nt was observed a change of the pressure pulse immediately after the start~     of and during exposure to EEFLE, modulated according to a set of specific frequencies~     recorded by digital photoplethysmography. This study aims to evaluate an autonomic response~     in individuals exposed in a single moment, by electromagnetic fields. This study does not~     intend to study a diagnostic or therapeutic procedure. For this reason, evolutive clinical~     data will not be considered during and after the study.~   "
143701|NCT01686399|"~     The aim of this protocol is to use a multidisciplinary approach to convey nutrition and~     activity messages to randomly selected Hadassah Medical Center employees. The intervention~     will be for one academic year and include frontal talks, email and internet focus group~     interactions, public demonstrations and a focused intervention within the hospital kitchen.~      The outcomes are specific parameters of dietary modifications, degree of physical activity~     and health related perspectives. Outcomes will be recorded at baseline and by the end of the~     intervention ( one year).~   "
143702|NCT01686386|"~     This is an open Label, Phase I/II, multicenter study. In the first phase it defines the~     maximum tolerated dose (MTD) of Bendamustine (B) given in combination with Lenalidomide (L)~     and low-dose Dexamethasone (d) and in the second phase it evaluates the antitumour activity~     of Bendamustine, Lenalidomide and Low-dose Dexamethasone (BdL) given in combination, in~     relapsed multiple myeloma patients.~   "
143703|NCT01686373|"~     The purpose of this study is to assess the changes in language processing of patients with~     chronic, post-stroke aphasia following the application of brain stimulation. The brain~     stimulation the investigators administer is called transcranial direct current stimulation~     (tDCS). It involves passing a weak electrical current through the brain between two~     electrodes in the form of damp sponges. One sponge will be placed over a specified area on~     the damaged left hemisphere, while the other sponge will be placed on the right scalp.~     Computer-controlled speech-language treatment will be administered during the application of~     tDCS.~   "
143704|NCT01686360|"~     The purpose of this study is to test the effects of objective risk information about breast~     cancer and mammography outcomes using a randomized control trial. Women between the ages of~     35 and 49 will receive information about their personal risk for breast cancer and be~     randomly assigned to receive data about a woman who should be screened, data about the~     potential outcomes of screening, or data about breast cancer deaths. Two presentation formats~     will be tested and compared.~   "
143705|NCT01686347|"~     The aim of the investigators study is to demonstrate the association between fetal cardiac~     rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine~     and/or sufentanil.~   "
143706|NCT01686334|"~     The primary aim of this innovative immunotherapeutic study is to determine whether the~     antileukemic effects seen in our previous phase I/II study can be confirmed in a large cohort~     of patients and whether dendritic cell vaccination can significantly prevent relapse and~     increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual~     disease.~   "
143707|NCT01686321|"~     Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's~     lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies~     have investigated the role of bendamustine in the treatment algorithm. The aim of the current~     B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of~     bendamustine and subcutaneous rituximab in old patients or in elderly patients with high~     comorbidity who do not qualify for a CHOP like treatment. The results of this study will form~     the basis of a larger, prospective randomized phase III trial.~   "
143717|NCT01686191|"~     Kidney disease is a common problem after heart transplantation. It may be caused by~     anti-rejection medications such as cyclosporine or tacrolimus. However, the reason why some~     people develop kidney problems after a heart transplant, but other people do not, is not~     fully known. This study plans to learn more about the relationship between a person's genetic~     make-up (DNA; deoxyribonucleic acid) and the risk of kidney problems after a heart~     transplant. The long-term goal of this research is to identify genetic variations that may~     help predict the development of kidney problems after heart transplantation.~   "
143708|NCT01686308|"~     Cataract is globally the most common cause of blindness and in Denmark the operation with -~     50.000 treatments per year - is the most common eye operation. The cause of cataract is~     growth and denaturation of the lens proteins. This leads to an increased absorption of blue~     light and increased light scatter. This may affect newly discovered cells in the retina that~     are involved in the regulation of the circadian rhythm. When the internal circadian rhythm is~     not synchronized with the external day and night a phase-shift occurs. Most people know of~     this discomfort as jet-lag, but the consequences may be much more severe such as heighten~     risk of cancer and cardiovascular disease.~      The goal of this project is to study how the circadian regulating cells of the retina is~     affected by cataract and by the operation. Cataract patients are studied before and after the~     operation with questionnaires, hormone and activity measurements and with a specialized pupil~     measurement that measures the indirect response of the circadian regulating cells to blue~     light.~      Results from this study aim to shed light on the regulatory mechanisms of the eye on the~     circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular~     lens is evaluated. This may have impact on clinical practise especially with regard to choice~     of intraocular lens and widened indications for cataract surgery.~   "
143709|NCT01686295|"~     The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation~     System when used as directed in promoting hair growth in men and women with androgenetic~     alopecia~   "
143710|NCT01686282|"~     Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans~     have been more concerned about their blood cholesterol levels and dietary cholesterol intakes~     rather than their overall cardiovascular health risk factors leading to CVD such as~     hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and~     physical activity. Statistics show that approximately 91% of individuals with CVD have~     vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to~     increased arterial stiffness.~      The investigators long-term goal is to provide feasible and effective dietary ways for pre-~     and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve~     vascular function and thereby reducing their cardiovascular risk and enhancing the quality of~     life. Blueberries are a rich source of phenolic compounds and these compounds may play an~     important role in promoting cardiovascular health. Considering the strong possibility that~     phytochemicals present in blueberry work additively or synergistically, it would be ideal to~     investigate the cardioprotective effects of blueberry as a whole. The investigators overall~     objective to bring forth evidence that blueberry consumption will reduce BP and~     cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and~     autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The~     investigators hypothesize that blueberry supplementation will improve vascular function and~     will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this~     study will provide a foundation for disseminating feasible, safe approaches for preventing~     and combating hypertension at its early stage which does not require drug therapy.~   "
143711|NCT01686269|"~     Vascular stenosis as a result of neointimal hyperplasia is a major clinical problem that has~     an impact on multiple and diverse disciplines, including cardiology (coronary restenosis),~     cardiothoracic and vascular surgery (saphenous vein and polytetrafluoroethylene [PTFE] graft~     failure), neurology (carotid stenosis), nephrology (dialysis access dysfunction), and~     transplant medicine (chronic allograft rejection in hearts and kidneys). [1] In marked~     contrast to the deleterious effects of smooth muscle progenitor cells on neointimal~     hyperplasia, circulating endothelial progenitor cells (EPCs) are believed to play an~     important role in vascular repair and in the inhibition of neointimal hyperplasia. [2]~     Endothelial progenitor cells (EPCs) circulate in adult peripheral blood and contribute to~     neovascularization. Satoshi et al. have demonstrated that lineage-committed EPCs and~     CD34-positive mononuclear cells, their putative precursors, are mobilized during an acute~     ischemic event in humans. [3] Reduced levels of circulating EPCs independently predict~     atherosclerotic disease progression, thus supporting an important role for endogenous~     vascular repair to modulate the clinical course of coronary artery disease. [4] These~     observations prompt the hypothesis that circulating EPCs may provide an endogenous repair~     mechanism to counteract surgery-induced endothelial cell injury and to replace dysfunctional~     endothelium perioperatively. Therefore, the investigators examined whether levels of~     circulating EPCs correlate with time course and outcomes of coronary artery bypass surgery to~     establish a clinical role of endogenous endothelial repair mediated by circulating EPCs.~   "
143712|NCT01686256|"~     A Multi-Center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium~     Tc 99m EC20) in Women with Suspected Ovarian or Endometrial Cancer.~      Phase I - The proposed indication for FolateScan is disease or pathological assessment of~     ovarian or endometrial masses.~   "
143713|NCT01686243|"~     The aim of this study is to demonstrate the feasibility of a new technique using real time~     ultrasound guided paramedian approach to the epidural space. This approach will use~     transverse view of the spine utilizing curvilinear low frequency ultrasound probe Sonosite S~     nerve and echogenic 17G tuohy needles  Pajunk TuohySono~      The investigators believe that this new technique is helpful to get the best anatomic~     landmark for epidural catheter placement using the real-time ultrasound.~      Measurable outcomes:~        -  Block performance time.~        -  Block success rate.~        -  Needle Depth to epidural space~      Block success rate will be measured as the rate of cases that will have successful insertion~     of the epidural catheter using ultrasound guidance and the case is done completely under~     epidural anesthesia.~      All cases that will be converted to general anesthesia will be counted unsuccessful.~      Other measurable outcome data that will be collected will include needle depth to the~     epidural space, and ultrasound measured depth to the lamina~   "
143714|NCT01686230|"~     This trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic~     stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and~     waiting-list. And to confirm the specificity of acupoints on meridian.~   "
143715|NCT01686217|"~     The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different~     strengths of ASP015K extended release formulation and an immediate release formulation and to~     evaluate food effect on extended release strengths in healthy volunteers.~   "
143719|NCT01686165|"~     This study looks at what effects (good and bad) a drug called PXD-101 (belinostat) in~     combination with the radioactive drug Zevalin (yttrium Y 90 ibritumomab tiuxetan) has on~     patients with relapsed aggressive (high-risk) non-Hodgkin lymphoma. Studies in the laboratory~     suggest that drugs such as PXD101 can act upon specific cancer cell processes to cause either~     death of the cancer cells or prevention of their growth. In human studies with a small number~     of patients with this lymphoma, PXD-101 has shown the ability to shrink and slow tumor~     growth. When Zevalin is delivered directly to the tumor, the lymphoma cells are destroyed and~     this may result in the disappearance of the tumor (remission)~   "
143720|NCT01686152|"~     To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and~     Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic~     keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy~     of each of the two active treatments is superior to that of the Vehicle cream.~   "
143721|NCT01686139|"~     Diabetes Mellitus (DM) can be regarded as one of the epidemics of the western world.~      DM contributes to severe morbidity and mortality due to damage in the target organs~     (neuropathy, vasculopathy, nephropathy, retinopathy).~      It affects the quality of life of the patients because of increased rate of blindness, IHD,~     stroke, end stage renal failure, hemodialysis and lower limb amputations (LLA).The Diabetic~     Foot (DF) is defined as destruction or infection of tissue/s in the foot of diabetic patients~     due to neurological damage and / or different levels of Peripheral Vascular Disease (PVD).~     Diabetic foot complications are the most common cause of lower extremity amputations in the~     industrialized world. The lifetime occurence of Diabetic Foot Ulcers (DFU) is 20% in diabetic~     patients.~      Between 15% - 25% of the foot ulcers will lead to lower limb amputations.~      It has been shown that Mesenchymal Stem Cells (MSCs) could be an effective therapy for many~     diseases including acute respiratory distress syndrome, spinal cord injury, liver injury and~     critical limb ischemia.~      Stem cells can be obtained from either the patient (autologous) or non-related healthy donors~     (allogeneic).~      The purpose of this study is to determine the safety and efficacy of cultured Bone Marrow~     Mesenchymal Stromal Cells (BM-MSCs) from allogeneic donors for treatment of chronic leg~     wounds of diabetic patients.~   "
143722|NCT01686126|"~     Currently the standard treatment for early stage endometrial cancer or endometrial~     hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and~     removal of both ovaries. While highly effective, this surgery carries significant side~     effects for:~        -  young women who still wish to have children and would lose fertility; and~        -  women with one or more disorders (or diseases) in addition to the early stage~          endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are~          at risk for surgical complications making surgery unsafe.~      This study will access a new approach to the treatment of endometrial cancer to spare women~     of having to undergo major surgery that may be unwanted or unnecessary.~      Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent~     thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement~     therapy (HRT). However it is not approved to treat early stage endometrial cancer or~     endometrial hyperplasia with atypia. This research project will test to see if Mirena is an~     effective treatment for early stage endometrial cancer and endometrial hyperplasia with~     atypia.~      Metformin is approved in Australia to treat Diabetes. However it is not approved to treat~     early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an~     experimental treatment for early stage endometrial cancer and endometrial hyperplasia with~     atypia. This means that it must be tested to see if it is an effective treatment for early~     stage endometrial cancer and endometrial hyperplasia with atypia.~      Weight loss interventions are feasible and safe, and already being implemented by~     gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight~     induces a large biological effect (for example reduces incidence of diabetes by 58%, and~     hypertension by 26%).~   "
143723|NCT01686113|"~     This study will examine whether or not short, daily exposures change a person's ability to~     detect free fatty acids in a solution by its taste. Repeated exposure should improve a~     person's ability to detect free fatty acids.~   "
143724|NCT01686100|"~     Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients~     with coronary artery disease. This is done by using alternative blood vessels (grafts) to~     bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where~     surrounding tissue is removed, this may damage the vessel and influence its patency.~      The no-touch technique was developed by Professor Domingos Souza at the Department of~     Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes~     taking out the vein with its surrounding tissue and by this way the vessel is less damaged.~     The first two follow ups have shown that no-touch grafts had better patency than~     conventionally extracted graft at 18 months and 8.5 years.~      This long term follow up is a continuation of the randomized trial started in 1993 where the~     patency and incidence of stenoses in the no touch and conventional vein grafts has been~     studied.~   "
143725|NCT01686087|"~     The goal of this study is to understand whether patients with obsessive-compulsive disorder~     (OCD) on serotonin reuptake inhibitors (SRIs) who receive a type of Cognitive-behavioral~     therapy called Exposure and Ritual Prevention (EX/RP) can discontinue their medication if~     they first do well with EX/RP.~   "
143726|NCT01686074|"~     This project is a comprehensive study, with main focus on motor control, comparing patients~     with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome~     (FMS). Focus of the present project will be on detailed movement analysis in a movement~     laboratory and involve functional tasks such as walking and standing. Investigations will~     also comprise muscle activity, reaction time and fine motor control.~   "
143727|NCT01686061|"~     The purpose of this survey is to collect detailed information on patients treated for~     blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including~     how often they are treated with botulinum toxin, how long their treatment lasts, how~     satisfied they are with their treatment, and if there is any improvement in their symptoms~     with the treatment.~   "
143728|NCT01686048|"~     Ambrosia is known for its allergenicity in the USA causing hay fever and asthma. Israel has~     always been considered clean of Ambrosia but over the past years growth of Ambrosia plants~     has been detected in several locations in Israel.~      In the proposed study, patients referred for routine allergic evaluation will also be skin~     tested with Ambrosia allergens, in addition to their regular prick skin tests with all other~     airborne allergens.~   "
143729|NCT01686022|"~     Allergic rhinitis patients are the patients who have nasal symptoms when triggered by indoor~     or outdoor allergens. Outdoor allergen can be divided into grass, tree, or weed. The type of~     grass or weed are different in various part of the world. The allergens from grass and weed~     has never been studied in Thailand. This study will find the major allergen from Bermuda~     grass, Johnson grass, Para grass, sedge, and ragweed, which are very common in Thailand. In~     addition, the investigators will study about the cross-reactivity among these group of~     allergen.~   "
143730|NCT01686009|"~     The provision of analgesia to patients in pain is a fundamental necessity of emergency~     department practice and is usually accomplished using IV opioids. However, significant~     barriers exist to the provision of timely analgesia by the IV route.~      The use of the IN route for medication delivery provides an efficient and relatively painless~     mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and~     to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring~     that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid,~     easy-administered and well-tolerated method for providing analgesia in the ED setting.~   "
143731|NCT01685996|"~     Randomized trial to evaluate whether zonisamide can enhance varenicline-induced smoking~     cessation.~   "
143732|NCT01685983|"~     The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral~     abiraterone acetate and oral prednisolone in men with metastatic-castration resistant~     prostate cancer (mCRPC) and with disease progression following treatment with a~     docetaxel-containing chemotherapy.~   "
143733|NCT01685970|"~     Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel~     preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance~     patient tolerability and have similar bowel cleansing efficacy compared to standard method~     using high volume split-dose PEG.~      The investigators aimed to evaluate the efficacy and tolerability of bowel preparation~     protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L)~     split-dose for afternoon colonoscopy.~   "
143734|NCT01685957|"~     Recent decades have shown an alarming increase in obesity. Obesity is associated with high~     costs for both the individual and for society. It is therefore important to prevent and treat~     obesity. The investigators believe that if you add a self-help weightloss book and teach~     cooking skills to a standard dietary treatment, then it will result in greater weight loss~     than with dietary treatment alone. However, this has not yet been studied. Since it will~     require more resources, it is important to investigate whether it also works better before~     changing the current treatment.~      Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and~     cooking classes are more effective than dietary treatment alone in changes in body weight and~     body composition in obese persons over a period of 12 months. There is no difference if the~     intervention are based on the national dietary guidelines or a relative low-gi and~     high-protein diet.~      Secondary to investigate the impact the interventions have; on diet quality and quantity, on~     markers of metabolic syndrome and on how many subjects complete the study.~   "
143735|NCT01685944|"~     This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body~     fat and body weight in subjects with BMI 25-30 kg/m2.~   "
143736|NCT01685931|"~     The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly~     dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated~     by oral antipsychotics and with acute symptom of schizophrenia.~   "
143737|NCT01685918|"~     Study objectives~        1. Comparison of drug persistency rates between elderly RA patients and young RA patients~          with biological DMARDs~        2. Analysis of discontinuation reasons & influencing factors of drug discontinuation in~          elderly RA patients and young RA patients~        3. Comparison of the occurrence of adverse events & treatment outcomes between elderly RA~          patients and young RA patients~   "
143738|NCT01685905|"~     The purposes of this study~        1. to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G),~          and determine the level of agreement between two tests in patients with rheumatic~          diseases~        2. to evaluate the difference in the occurrence of active TB in patients who receive both~          QFT-G and TST compared with those who receive only TST for detecting of Latent~          tuberculosis infection(LTBI) who are candidates of TNF inhibitors.~   "
143739|NCT01685892|"~     This multi-center, open-label, dose-finding study will evaluate the safety and~     pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199)~     administered in combination with obinutuzumab to participants with relapsed/refractory or~     previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages~     for each participant population: a dose-finding stage and a safety-expansion stage. The~     dose-finding stage will explore multiple doses of venetoclax to be used in combination with a~     fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug~     administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B~     (venetoclax introduced after obinutuzumab).~   "
143740|NCT01685879|"~     Certain types of rice have more dietary fiber than others. This type of rice is known a high~     amylose rice. This study hypothesizes that high-amylose rice, will decrease blood glucose~     and insulin responses after consumption compared to conventional rice in healthy adults, ages~     18-40. Eighteen healthy men and women will participate in this study. This study will~     determine how high blood glucose and insulin values rise after eating a portion of rice. This~     study will also evaluate hunger ratings after consuming rice. The results of this study will~     help researchers better understand how diet can influence diabetes management.~   "
143741|NCT01685866|"~     Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral~     veins in children having forecasted difficult venous access and could facilitate the venous~     access.The main goal is to reduce the time necessary to get a venous access during the~     inhalation anesthesia induction.~   "
143742|NCT01685853|"~     The present study is intended to evaluate the effectiveness, tolerability, compliance, and~     feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L~     Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of~     colonoscopy, vs the standard 4L split PEG solution.~   "
143743|NCT01685840|"~     The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy~     compared with usual care in high risk patients with left ventricular systolic dysfunction.~   "
143744|NCT01685827|"~     This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral~     treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared~     to reference treatment NECT. The trial will try to demonstrate that Fexinidazole is not~     inferior to NECT treatment.~   "
143745|NCT01685814|"~     The investigators propose this study utilizing Lenalidomide, Adriamycin, Dexamethasone (RAD)~     as comparator arm for Lenalidomide, Bortezomib, Dexamethasone (VRD) with the latter being~     considered a novel standard as an induction protocol, since response in general occurs~     early after starting treatment we decided to choose three cycles of either induction regimen.~      Together with the novel compounds, tandem high-dose melphalan is still the standard of~     care; it seems desirable to re-address the question of the number of transplant (single vs.~     double high-dose melphalan) procedures required in the context of triplet-induction protocols~     utilizing at least one of the novel compounds.~      Thus, the question to be asked in the current protocol is whether immediate lenalidomide~     maintenance (i.e. following one cycle of high-dose therapy) as an investigational agent will~     result in identical progression free survival (PFS) when compared to tandem high-dose~     melphalan with deferred maintenance therapy.~      Despite induction with novel compounds, approximately 25 - 40% of patients will be in less~     than very good partial response. Very recently, achievement of less than VGPR was confirmed~     to negatively impact on both PFS as well as overall survival (OS). Therefore, allogeneic stem~     cell transplantation is considered the standard of care in patients with suboptimal response~     to a first autograft.~      In the current protocol, the standard for favourable responders (tandem-autologous~     transplant) is combined with 3 years of lenalidomide maintenance. This approach will be~     investigated for patients with less than VGPR following a first autotransplant and compared~     to the current standard of intensification in poor responders (allogeneic transplantation).~   "
143746|NCT01685801|"~     This study is a multiple within participant crossover study to evaluate the effect of~     ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF)~     who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator~     (CFTR) function.~   "
143747|NCT01685788|"~     The overall aim of the project is to gain insight in sensory deficits and recovery patterns~     in the upper limb post stroke and its association with brain lesion localisation.~     Furthermore, the investigators will identify associations of deficits in sensory modalities~     with upper limb impairments, activities and participation at different time points after~     stroke. Identification of the sensory deficits, along with further insights in their relation~     with objective neurophysiological and neuroanatomical measures will contribute to the~     amelioration of goal-setting for the rehabilitation of upper extremity function after stroke.~     These functions are indispensable during several daily activities as well in different sports~     and leisure activities. This project is an important step towards a better delineating of~     treatment interventions for the upper limb and to a better guiding of individual needs for~     post-stroke treatment in the future.~   "
143748|NCT01685775|"~     Laparoscopic surgery has become the golden standard for the removal of the gallbladder.~     Recently, developments have been made so that operations can be performed through a natural~     orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study~     compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation~     using 2-3mm instruments in female patients. It also examines the benefits and disadvantages~     related to postoperative pain, cosmetic aspects, and potential physiological alterations to~     the transvaginal approach that affect sexual intercourse.~   "
143749|NCT01685762|"~     The purpose of this study is to see if metformin will be effective in making endometrial~     hyperplasia without atypia better by returning the tissue to a normal state.~   "
143750|NCT01685749|"~     Stingray injuries can be a hazard shared by many types of beachgoers. Stingrays often lie in~     the sand and when stepped on by the unsuspecting beachgoer their tail snaps foreword,~     resulting in a barbed stinger injecting venom into the victim. Little exists in the current~     literature on the natural history of stingray injuries. Most of the existing literature looks~     at the incidence of stings, and to a certain extent the demographic of people who seek care.~     To our knowledge no study has attempted to collect a more inclusive population of those~     people who are stung and follow them prospectively to determine the incidence of medical~     intervention, infection, etc.~      This study aims to describe and quantify the natural history of stingray injuries and to~     better understand their time course and medical requirements. The study setting will be Seal~     Beach, which reports some of the greatest number of annual stingray injuries for any single~     beach on the pacific coast. Participants will be identified by the Seal Beach lifeguards who~     are believed to treat the majority of stingray injuries suffered at the beach. Eligible~     persons will be consented for participation over the phone by research personnel. If enrolled~     in the study they will receive a phone call by research personnel one week and one month~     after the injury that will collect information about the symptoms they have experienced and~     the medical interventions they have received, if any. This study is strictly observational in~     nature and will not involve any interventions on the part of study personnel or alter the~     manner in which or types of medical assessments or treatments.~   "
143751|NCT01685736|"~     Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements,~     24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that~     allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3~     nights, 3 readings/night).~   "
143771|NCT01685476|"~     In clinical practice, intracranial pressure (ICP) represents a key parameter for diagnosing~     and treating several conditions. Physicians having to manage cases of head trauma, stroke and~     hydrocephalus need to assess the time course of ICP, yet they are often unwilling to~     implement invasive monitoring beyond the acute stage, on account of high septic risks.~     Standard techniques include direct ventricular manometry or measurement in the parenchyma~     with electronic or fiberoptic devices. Therefore, the design of non-invasive clinical methods~     for gaining access to pressure changes is an important challenge. Fluctuations of ICP are~     transmitted to the fluid spaces of the inner ear through the cochlear aqueduct. The~     Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the~     intra-labyrinthic pressure modify the functional activities of the outer hair cells in the~     cochlea. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure,~     which is detected as modifications in cochlear activities. Cochlear activities' recording are~     non-invasive and technically simple. A probe is gently inserted into the outer portion of the~     external ear canal.~      The objective of this study is to assess prospectively the accuracy and the precision of a~     new method for ICP monitoring (using cochlear activities) compared with invasive gold~     standard CSF pressure monitoring.~   "
143752|NCT01685723|"~     Background: Smoking cessation can largely improve cancer prognosis and quality of life among~     cancer patients. However, few patients are aware of the importance to quit at the stage, or~     they have difficulties to quit by self.~      Aim: to examine the effectiveness of a smoking cessation intervention using a risk~     communication approach~      Design: A randomized controlled trial~      Setting: Outpatient clinics of the Clinical Oncology Departments of five major hospitals in~     different regions of Hong Kong~      Subject: Smokers who attend medical follow-up visits at outpatient clinics of the Clinical~     Oncology Departments of five major hospitals in different regions of Hong Kong and who met~     the inclusion criteria were invited to participate.~      Intervention: At baseline, intervention group receives:~        1. a face-to-face individualized brief advice based on risk communication for 15-30 minutes~          from the nurse counselors;~        2. examination of exhale CO level; and~        3. a generic standard self-help smoking cessation booklet. They will receive a booster~          intervention at 1 week. Control group will receive standard care and a generic self-help~          smoking cessation booklet.~      Outcome: Primary outcome is the self-reported 7-day point prevalence quit rate at 6-month~     follow up. Secondary outcomes include:~        1. self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up;~        2. biochemically validated quit rate at 6-month follow-up; and~        3. percentage of patients reduced smoking by at least 50% at 6- and 12-month follow-up~          compared to baseline.~      Significance: This study develops and validates practical smoking cessation interventions~     targeted to cancer patients to improve their cancer prognosis and in long-term.~   "
143753|NCT01685710|"~     The aim of the study is to determine whether the application of a glyceryl trinitrate patch~     (GTN patch) helps arteriovenous fistulas, created for renal dialysis access, mature so that~     they can be used.~   "
143754|NCT01685697|"~     Most premature babies have difficulty breathing at birth and need help (what we call~     resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation~     device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we~     call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world.~      To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth~     and nose. The clinical team tries to achieve a good seal between the face and the mask. A~     problem of mask ventilation is that air can escape between the mask and the face (what we~     call mask leak). Currently, two different types of facemasks (Laerdal mask or Fisher &~     Paykel mask) are routinely used in the delivery room at The Royal Alexandra Hospital.~      The purpose of this study is to find out if one facemask is leaking less between the face and~     the mask.~   "
143755|NCT01685684|"~     The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared~     with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic~     low back pain requiring around-the-clock opioid analgesia for an extended period of time.~   "
143756|NCT01685671|"~     The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after~     SC administration in health male volunteers~   "
143757|NCT01685658|"~     The main objective of this study was to demonstrate the non-inferiority of intravenous~     paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency~     ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30~     minutes.~   "
143758|NCT01685645|"~     The pupillary pain-meter AlgiScan ® with integrated nociceptive stimulator is a portable,~     battery-operated device which automatically measures, by means of an infrared camera, pupil~     diameter. This is measured in response to noxious stimulation produced by a tetanus at a~     frequency of 100 Hz for 5 seconds. Its intensity varies from 10 to 60 mA. The recording is~     performed for a period of 13 seconds (3 seconds prior to stimulation, stimulation for 5~     seconds, 5 seconds after the stimulation). An interval of 3 minutes is allowed between the~     two measurements (right and left), which is significantly higher than the time necessary to~     return to normal (about 20seconds).~      The pupillary pain index (PPI) ranges from 0 to 10 and is a composite measure of the~     pupillary diameter reflex to the tetanus stimuli delivered by the AlgiScan device. Smaller~     scores indicate increased analgesia.~      The main objective of this study is to determine whether PPI index variation can determine a~     prognostic threshold of analgesic efficacy of unilateral lower limb sensory nerve block~     before incision. The measurements are performed after bilateral nociceptive stimulation~     (blocked side versus non-blocked side) in patients under general anesthesia for major knee~     surgery.~   "
143759|NCT01685632|"~     Intra Peritoneal Chemo Hyperthermia (IPCH) is a recently validated option for the treatment~     of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program~     demonstrated a significant improvement of the late stages (i.e. carcinomatosis) of the~     disease. From a clinical point of view, within the first 24 hours after IPCH, patients~     undergo a systemic inflammatory response syndrome, and therefore require to be monitored in~     an intensive care unit. From a metabolic perspective, preliminary data have been shown a~     significant anaerobic style disturbance of energetic metabolism, suggesting a deep cellular~     energetic deficit throughout IPCH process.~      Putative contradictory effects of IPCH, like the increase of chemotherapy-related cellular~     toxicity due to heat and on the other hand the initiation of a stress protein response (heat~     shock response) which helps to reduce the cell injuries, leads to conduct a research project~     on the underlying mechanisms: consequences, in terms of patient's care and follow-up, are of~     high relevance.~      The primary goal is a multimodal assessment of the IPCH-related cell modifications: signaling~     pathways, apoptosis and antitumoral immune response.~      The assessment criteria include Heat shock protein expression (blood/cell ratio) compared to~     baseline values, apoptosis and immune response before/after IPCH.~      The scheduled sample size is 30 patients having an IPCH and 30 patients contraindicated per~     surgery.~   "
143781|NCT01685346|"~     This is a pilot study to test the hypothesis that biofeedback-mediated stress management~     (BFSM) training can be used to reduce distress and enhance quality of life in patients with~     non-small cell lung cancer (NSCLC). Most patients with advanced NSCLC have significant~     physical symptoms, but even those who do not have physical symptoms have high levels of~     anxiety and depression.~   "
143783|NCT01685320|"~     Forces applied on soft upper tissues by different laryngoscope blades during direct~     laryngoscopy and intubation are considered to be major stimuli to cause serious damages to~     the patients. The aim of this study is to compare the force and pressure applied to soft~     tissue in order to achieve the same glottis view comparing direct laryngoscopy and~     videolaryngoscopy in vivo.~   "
143760|NCT01685619|"~     This clinical study will provide the study specimens (samples of bone marrow and blood) and~     the clinical data for a pan-Canadian collaborative research project developed by the MDS/AML~     Research Consortium. The goal of this project involves the evaluation and potential~     validation of five novel prognostic tests for myelodysplasia (MDS) and/or acute myeloid~     leukemia (AML), as well as an analysis of health economic and socio-ethical implications~     related to the potential introduction of these tests into the clinical setting. The~     over-arching goal is to improve the outcomes of patients with MDS and AML. The primary~     hypothesis is that one or more of the laboratory tests being evaluated in conjunction with~     this study, either alone or in combination with other laboratory tests (either established or~     under investigation in this project), will have statistically significant prognostic value~     either alone or in combination with established clinical risk factors.~      The clinical study will involve the enrollment of 200 adults with AML and 200 adults with MDS~     over a 2.5 year period. Participants will be followed on study for two years. Bone marrow and~     blood specimens will be collected at diagnosis and at other time points as required for the~     development of the five laboratory tests.~      Participants will be assigned to treatment according to local institutional practice and will~     be followed for up to 2 years. Health economic and quality of life questionnaires will be~     administered at key time points. Data will be collected regarding participant~     characteristics, diagnosis, disease features, treatment and clinical outcome.~   "
143761|NCT01685606|"~     The study of whether an infusion of blood cells called lymphocytes from a donor can stimulate~     the immune system to fight your leukemia/lymphoma.~   "
143762|NCT01685593|"~     We conducted a controlled randomized trial examining the ability of the Mott abdominal~     Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy~     patients~   "
143763|NCT01685580|"~     Surgical treatment is the standard treatment for localized forms of lung cancer non-small~     cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is~     a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing~     this procedure is a major public health issue. The non-invasive ventilation is a technique~     commonly used postoperatively in acute respiratory distress and in the treatment of sleep~     apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the~     non-invasive ventilation achieved during 7 days minimum before the intervention could~     significantly reduce postoperative complications in patients with an obstructive or~     restrictive disorder, obesity or chronic heart failure.~      The aim of the study is to demonstrate that the non-invasive ventilation in two pressure~     levels achieved during at least 7 days before surgery lung resection (lobectomy or~     segmentectomy) halved the pulmonary and cardiovascular postoperative patients with~     obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.~   "
143764|NCT01685567|"~     The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™~     Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection~     during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also~     facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or~     diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA~     approved carotid artery stent for the treatment of carotid artery disease.~   "
143765|NCT01685554|"~     The aim of our study was to evaluate the effect of different temperature regimens of~     cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical~     correction of acquired heart diseases.~   "
143766|NCT01685541|"~     The electronic medical record (EMR) offers a new method to provide patients with information~     about their visits with a clinician. The EMR can generate personalized and patient specific~     handouts at the end of the visit that can recap the topics covered during that visit. These~     After Visit Summaries (AVS) can be automatically generated with information contained in the~     patient's chart. The AVS has the potential to improve patient retention of information needed~     for adherence to treatment plans, and follow-up instructions, and to facilitate information~     transfer between healthcare settings. However, the content and formatting of the AVS to~     optimize patients' information retention and satisfaction with the visit is not known. In~     this study, we will develop and test in a randomized trial three different versions of an AVS~     to determine the AVS content that maximizes patient satisfaction and retention of information~     on the AVS,and adherence to physician instructions. The three versions of the AVS developed~     from patient and physician input will be compared to a control condition which consists of~     current practice in each setting.~   "
143767|NCT01685528|"~     The purpose of this study is to determine the feasibility and acceptability of providing~     evidence-based, person-centered, culturally tailored treatment for anxiety and/or depression~     via telephone to rural Veterans receiving home-based primary care.~   "
143768|NCT01685515|"~     The purposes of this study are to observe if oral tetrahydrouridine and decitabine can~     increase fetal hemoglobin levels and improve the symptoms of sickle cell disease, and to~     monitor how patient's bodies react to oral tetrahydrouridine and decitabine.~   "
143769|NCT01685502|"~     The objective of this study is to assess the efficacy and safety under practical use of~     Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1~     year observation period.~   "
143770|NCT01685489|"~     This is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day~     lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by~     the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for~     three cycles. Study drug will be discontinued on day 15 of the third docetaxel cycle to allow~     for a 7-day washout period before the fourth dose of docetaxel. Pharmacokinetic (PK) analysis~     of docetaxel will be conducted during docetaxel cycle 1 (combination therapy) and cycle 4~     (docetaxel alone). Serum for future PSK PK analysis will be collected on days 1, 3, and 15 of~     PSK/placebo lead-in and during cycles 1 and 4.~   "
143782|NCT01685333|"~     The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and~     pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects~     following administration of single intravenous dose. The objective of this randomized,~     crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of~     the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced~     by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count~     following a single-dose intravenous administration of 100 IU/kg in healthy subjects.~   "
143772|NCT01685463|"~     Specific Primary Aims include:~      Aim # 1. The investigators explore the feasibility of using the TMS to investigate the~     cortical excitability and to inhibit meth cue craving in meth dependent population. The~     investigators anticipate that meth elevates cortical excitability measured by motor~     threshold, causes changes of cortical silent period, and RC. The investigators also~     anticipate that paired pulse measures (short-interval intracortical inhibition,~     short-interval intracortical facilitation and long-interval intracortical inhibition) will be~     different from healthy control, which are more directly linked to glutamatergic cortical~     facilitation and GABAergic inhibition, respectively.~      Aim # 2. Given the change of the cortical excitability in meth users, the investigators will~     use inhibiting TMS (1 Hz) over medial prefrontal cortex to study whether TMS can be used to~     reduce cue craving. The investigators hypothesize that repetitive TMS reduce meth cue craving~     in meth dependent population compared with sham rTMS.~   "
143773|NCT01685450|"~     The intracranial pressure (ICP), defined by the hydrostatic pressure of the cerebrospinal~     fluid (CSF), is a key parameter for diagnosing and treating several neurosurgical diseases.~     Continuous ICP monitoring has an important place in neuro-intensive care for patients with~     severe head trauma and severe meningeal hemorrhage.~      Until now the assessment of ICP requires invasive methods, with a pressure transducer either~     within the ventricular CSF or within the brain parenchyma. The pressure sensor placement is~     performed in a neurosurgery department. These invasive methods have also disadvantages:~     highest risk of infections, catheter misplaced, and risk of bleeding. All these justify the~     development of a non invasive method. The Biophysics Laboratory (School of Medicine of~     Clermont-Ferrand) described that the intra-labyrinthic pressure (ILP) modify the functional~     activities of the outer hair cells in the cochlea.~      Cochlear activities' recording is non-invasive and technically simple. A probe is gently~     inserted into the outer portion of the external ear canal.~      Anatomical studies showed communication between the subarachnoid spaces and the perilymphatic~     compartment by the cochlear aqueduct. Thereby, increases in ICP are transferred to increases~     in intra-cochlear pressure, which is detected as modifications in cochlear activities.~      CSF dynamic tests, as constant flow infusion test, are conducted in patients in the diagnosis~     of the idiopathic adult hydrocephalus syndrome. Artificial CSF is infused through a lumbar~     needle, into the CSF space at a constant rate, and the corresponding rise in ICP is~     registered and analyzed.~      The objective of this study is to assess prospectively the accuracy and the precision of a~     new method for non invasive ICP measurement (using cochlear activities) compared with~     invasive gold standard CSF pressure measurement during CSF dynamic tests.~   "
143774|NCT01685437|"~     This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in~     subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21~     days before the initial injection of study drug in the first treatment cycle. Enrollment will~     include all subjects who meet the eligibility criteria and who received placebo and completed~     one of the Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804.~   "
143775|NCT01685424|"~     This postmarketing study was conducted to describe prescribing patterns for etoricoxib~     (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded~     in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA)~     General Practice Research Database (GPRD).~   "
143776|NCT01685411|"~     This is a treatment guideline to allow routine clinical data to be collected and maintained~     in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as~     part of the historical database maintained by the department.~   "
143777|NCT01685398|"~     Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population.~     The characteristic natural history of this tumor is rapid growth in the first year of life~     and follows by spontaneous involution. However, it may cause cosmetic unacceptable. Early~     intervention in superficial IH may help to minimize the risk of residual aesthetic problems.~     Topical timolol, a non selective beta-blocker, is an emerging treatment which has been~     reported in efficacy and safety for the treatment of IH. However, the reported studies were~     case-series or small study. This study is a prospective double-blind,randomized-controlled~     study to evaluate the efficacy and safety of 0.5% timolol maleate solution for treatment in~     superficial IH. The patient will be treated with topical timolol for at least 6 months and~     instructed to 4 times daily apply 1-2 drop of timolol solution on the lesion and rub over the~     entire lesion with a finger. Photographs of the lesion will be taken at the baseline and~     every 1-month visit. Clinical evaluation of the treatment efficacy is carried out by 2~     investigators independently to determine the change in lesion size and visual analogue scale~     of the lesion color. The main outcome is to evaluate the efficacy of 0.5% timolol maleate~     solution in treatment of infantile hemangioma compared to placebo.~   "
143778|NCT01685385|"~     Difficulty in breathing or increased rate of breathing are common causes of admission to~     intensive care unit. This may be due to heart failure, or other causes such as infection in~     the lungs. Treating doctors usually perform Chest X-ray, ECG, and other tests to know if~     breathlessness is due to heart failure or other cause. Doctors also give medicines to treat~     heart failure, or other conditions of the lungs based on the symptoms and investigation~     results. BNP is released by heart which is not functioning well. However BNP levels are also~     high in case of severe infection.Hence there is equipoise in utility of BNP measurements~     among critically ill patients, and it is not a current standard of care. The current cost of~     this test (about 1000 rupees per measurement) is high, and hence its utility needs to be~     carefully examined before a widespread use. The investigators intend to test the hypothesize~     that that on-admission BNP measurements, help clinicians identify CHF early, which may modify~     therapeutic decisions, and improve outcomes. The current study is designed with an objective~     to determine if on-admission BNP value and availability of its test results to treating~     physicians will reduce in-hospital, and 30-day mortality and in-hospital morbidity.~   "
143779|NCT01685372|"~     The purpose of this study is to determine whether Fluzone High Dose increases the immune~     response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone~     in immunocompromised children and young adults. Safety and efficacy data will also be~     collected.~   "
143780|NCT01685359|"~     The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau)~     pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®~     - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose.~     The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic~     and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau~     Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing~     plasma concentration of the drug and the reticulocyte count following a multiple intravenous~     administration during 4 weeks of 100 IU/kg in healthy subjects.~   "
143784|NCT01685307|"~     Few is known on meat protein digestibility in humans and the impact of cooking process, while~     excessive intake of processed meat has been suggested to increase the risk of colorectal~     cancer.~      This study aims to measure in vivo in humans the real digestibility of beef meat proteins~     depending 2 cooking processes, using ileal tubes and stable isotopes.~   "
143785|NCT01685294|"~     This study will examine the effects of a first-line treatment for major depressive disorder~     (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.~   "
143786|NCT01685281|"~     study objectives are to compare the efficacy, safety and tolerability of two doses of MG01CI~     (1400 mg and 700 mg) to Placebo for the treatment of symptoms in adults diagnosed with~     PI-ADHD.~      subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as~     follows:~        1. week 1:1400 mg, week 2:700 mg, week 3:placebo~        2. week 1:700 mg,week 2: placebo,week 3:1400 mg~        3. week 1: placebo, week2:1400 mg, week 3 700 mg~      The study will consist of three periods: a screening period of up to one week, a 3-week~     double-blind treatment period, and a one-week safety follow-up period.~   "
143787|NCT01685268|"~     A 2-part, Phase 1-2, open-label, parallel group, randomized study in patients with~     Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to treatment with~     abiraterone and steroids. In Part A (Phase 1), patients will continue to receive the same~     doses of abiraterone and steroids they were receiving prior to study entry and will be~     randomized to receive 1 of 2 different treatment regimens of AT13387 in combination with~     abiraterone. Once the best regimen is established in Part A, based on safety and antitumor~     activity, patients will be randomized to the selected treatment regimen and dose of AT13387~     in combination with abiraterone or AT13387 alone in Part B (Phase 2).~   "
143788|NCT01685255|"~     This is an open-label, randomized, phase 2 study of an IDO inhibitor, INCB024360 versus~     tamoxifen in biochemical recurrent only ovarian cancer patients following complete remission~     with first-line chemotherapy.~   "
143789|NCT01685242|"~     The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%~     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in~     the conjunctival allergen challenge (CAC) model.~   "
143790|NCT01685229|"~     This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS)~     patients treated with balloon sinus dilation (BSD) versus continued medical management.~   "
143791|NCT01685216|"~     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme~     glucocerebrosidase (GCB). Gaucher disease has been classified into 3 clinical subtypes based~     on the presence or absence of neurological symptoms and the severity of these neurological~     symptoms. Patients with type 2 Gaucher disease present with acute neurological deterioration,~     and those with type 3 disease typically display a more sub acute neurological course. Type 1~     Gaucher disease, the most common form accounting for more than 90% of all Gaucher disease~     cases, does not involve the central nervous system.~      The purpose of this clinical research study is to investigate the safety and effectiveness of~     velaglucerase alfa in patients with type 3 Gaucher disease.~   "
143792|NCT01685203|"~     The purpose of this study is to evaluate the safety and efficacy of co-administration of~     ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as~     ombitasvir) in adults with chronic hepatitis C virus infection.~   "
143793|NCT01685190|"~     Prostate cancer is the most common male cancer in the UK with 35,000 cases diagnosed~     annually. 35% of these are locally advanced disease. These patients have a high chance of~     pelvic lymph node involvement and have relatively poor prostate cancer survival rates of~     22.5% at 10 years.~      One of the standard treatments for these patients is radiotherapy to the prostate. PIVOTAL is~     a multi-centre phase II non-comparative randomised feasibility trial, in which patients with~     a high chance of pelvic lymph node involvement are randomised between prostate radiotherapy~     alone and prostate + pelvic radiotherapy.~      Both groups will receive radiotherapy called Intensity Modulated Radiation Therapy (IMRT).~     This is a relatively new method of shaping radiotherapy treatment beams which allows the~     tumour to be treated more precisely, whilst avoiding more of the surrounding normal, healthy~     tissues (particularly the rectum, bladder and bowel). Using IMRT, it is possible to deliver~     higher doses of radiotherapy to the pelvis than with previous radiotherapy methods - this has~     been tested in a single hospital, single group setting and levels of side effects (toxicity)~     were acceptable.~      PIVOTAL aims to find out whether toxicity levels at 18 weeks from the start of radiotherapy~     remain acceptable when treatment is given in multiple cancer centres across the UK. It is~     randomised to ensure unbiased collection of acute toxicity data and to provide information on~     patients' willingness to participate in a randomised study. Should the phase II study be~     successful, the investigators would develop a phase III trial to compare treatment~     effectiveness (disease control).~      Patients who enter PIVOTAL will be followed up for two years from the start of radiotherapy~     and data relating to toxicity will be collected. They will also be asked to complete patient~     related symptoms questionnaires. Data related to disease recurrence will then be collected~     annually from patients' standard hospital visits.~   "
143794|NCT01685177|"~     Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a~     modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is~     performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up.~     Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least~     equally to standard duodenal switch as a second step after sleeve gastrectomy in the~     super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal~     bypass is simpler to perform, quicker and has less postoperative short, mid and long-term~     complications.~   "
143795|NCT01685164|"~     As intrauterine contraception is an increasingly popular form of contraception the objective~     of our study is to examine if uterine size or posture affects the insertion or use of~     intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device~     (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.~   "
143796|NCT01685151|"~     To evaluate the efficacy and safety of once a day ramelteon tablets for sublingual~     administration (TAK-375SL) in the maintenance treatment of bipolar 1 disorder.~   "
143797|NCT01685138|"~     A single-arm, open-label, two-stage multicenter, phase II study. Patients will be~     pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd will continue until~     the patient experiences unacceptable toxicity that precludes further treatment, discontinues~     treatment at the discretion of the investigator or patient, starts a new anticancer therapy~     and/or dies. LDK378 may be continued beyond RECIST defined PD as assessed by the~     investigator, if in the judgment of the investigator, there is evidence of clinical benefit.~     Patients who discontinue the study medication in the absence of progression will continue to~     be followed for tumor assessment until the time of PD as assessed by the investigator. Male~     and female patients aged 18 or over with ALK-rearranged NSCLC will be screened for~     eligibility. Patients must have received no prior crizotinib, and must be chemotherapy-naïve~     or have been pretreated with cytotoxic chemotherapy (up to three prior lines)~   "
143798|NCT01685125|"~     This phase II trial studies how well giving abiraterone acetate and prednisone with or~     without dasatinib works in treating patients with metastatic, hormone-resistant prostate~     cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as~     abiraterone acetate, may lessen the amount of androgens made by the body. Dasatinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not~     yet known whether abiraterone acetate and prednisone is more effective than abiraterone~     acetate, prednisone, and dasatinib in treating prostate cancer~   "
143799|NCT01685112|"~     Although few cases reported successful treatment of septic shock using extracorporeal~     membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment~     (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a~     randomized study to allocate patients in such critical condition, we aimed to conduct a~     retrospective observational study using propensity score matched analysis to compare the~     survival of adults with septic shock treated by ECMO or conventional treatment.~   "
143800|NCT01685099|"~     1. To investigate the difference of PE inflammation/apoptosis-associated markers between TB~          pleurisy and non-TB pleurisy~        2. To investigate the difference of neutrophil apoptosis in exudative PE between TB~          pleurisy and non-TB pleurisy~        3. To investigate the change of apoptosis pattern of PE neutrophil, before and after TB~          antigen stimulation, and compare the difference between TB pleurisy and non-TB pleurisy~        4. To investigate diagnostic aid of the inflammation/apoptosis-associated markers and~          apoptosis pattern of PE neutrophil for tuberculous pleurisy~   "
143801|NCT01685086|"~     To follow-up the latent tuberculosis infection and evaluate the risk of developing active~     tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis~   "
143802|NCT01685073|"~     The number of people seeking treatment for marijuana-related problems is on the rise, yet~     there is no currently accepted medication proven to help them quit. Frequent marijuana users~     have reported that they have trouble sleeping when they try to quit, and that the loss of~     sleep can lead to relapse. This research is designed to measure the severity of sleep~     problems in people as they are trying to quit heavy use of marijuana, and to investigate~     whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to~     stop using marijuana.~   "
143803|NCT01685060|"~     A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd~     continued until the patient experienced unacceptable toxicity that precluded further~     treatment, discontinued treatment at the discretion of the investigator or patient, started a~     new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined~     progressive disease (PD) as assessed by the investigator if, in the judgment of the~     investigator, there was evidence of clinical benefit. In these patients tumor assessment~     would continue as per the schedule of assessments until treatment with LDK378 was permanently~     discontinued. Patients who discontinued the study medication in the absence of progression~     continued to be followed for tumor assessment until the time of PD as assessed by the~     investigator~   "
143804|NCT01685047|"~     The purpose of this investigation is to determine the prevalence of device-recorded ST~     segment changes occurring before appropriate ICD therapies (ATP or Shock) and to define their~     temporal relationship to ventricular arrhythmias.~   "
143805|NCT01685034|"~     Eosinophilic esophagitis (EoE) is a disease that has increased in incidence over the past~     decade that affects males predominantly, and in adults, is characterized by heartburn,~     dysphagia, strictures and food impactions. These symptoms may require emergent endoscopic~     removal of foods and esophageal dilations due to remodeling causing significant impairment in~     quality of life. Treatment options are limited and often not well tolerated or effective.~     There is poor understanding of the natural history and long term prognosis. It has been~     associated with allergic sensitization; a high percentage of affected individuals having~     associated atopy and current literature demonstrates a seasonal distribution of incidence and~     severity of symptoms. Allergy immunotherapy (AIT) is a well established and effective~     treatment for allergic rhinitis and asthma which can induce tolerance to environmental~     allergens.~      Given the efficacy of AIT and the association of aeroallergen sensitization and even seasonal~     variation of EoE symptoms, we hypothesized that AIT may be a treatment option for patients~     with EoE.~   "
143806|NCT01685021|"~     This is an open-label, multicentre study to characterize the safety and preliminary efficacy~     of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell~     acute lymphoblastic leukemia (B-ALL)~   "
143807|NCT01685008|"~     This is an open-label, multicentre study to characterize the safety and preliminary efficacy~     of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory~     non-Hodgkin´s lymphoma (NHL) who have received at least 1 prior therapy containing rituximab~     (at least once).~   "
143808|NCT01684995|"~     The goal of this study is to test, in combination with the nicotine patch, the incremental~     efficacy of a motivationally tailored behavioral intervention over a minimal intervention.~     The interventions will be delivered through primary care medical clinics. The defined~     population comprises low income, less educated smokers who will vary in their level of~     motivation to quit smoking. Patients will be randomly assigned within clinics to one of two~     interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and~     (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored~     motivational intervention, a behavioral skills counseling session for smoking cessation.~   "
143809|NCT01684982|"~     Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in~     patient with acute myocardial infarction treated with primary percutaneous coronary~     intervention (PCI)~   "
143810|NCT01684969|"~     This will be a blinded study to compare the absorption of topical haloperidol with placebo~   "
143811|NCT01684956|"~     The investigators are doing this research study to find out if the type of needle used to~     administer them affects the speed with which insulin and glucagon get into the blood. The~     investigators will compare a traditional insulin needle to an injection device, called the~     MicronJet, that uses microneedles to deliver medication into the top layer of your skin.~   "
143834|NCT01684657|"~     The purpose of this research study is to find out the potential benefits and safety of~     asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.~      It is hypothesized that individuals who are randomly assigned to asenapine will have an~     improvement in speech as compared to a placebo.~   "
143812|NCT01684943|"~     The investigators are doing this research study to compare the pharmacokinetics (rate of~     absorption) of insulin lispro (Humalog), insulin aspart (Novolog), and insulin glulisine~     (Apidra) within individual subjects.~      Additionally, the investigators will perform a preliminary feasibility evaluation of a~     minimally invasive continuous insulin monitoring (CIM) device and its use to derive PK~     parameters in human subjects.~   "
143813|NCT01684930|"~     The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high~     nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised~     exercise training at the limb ischemic threshold (SET) will produce a greater clinical~     benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic~     threshold (PET).~   "
143814|NCT01684917|"~     The overall objective of the research is to develop new methods for studying the link between~     diet, health and disease.~      The enquiry consists of two part. A metabolomic biomarker discovery study followed by a~     randomised controlled trial of moderate dietary induced weight loss.~      A cohort of moderately overweight men and women will undergo a metabolomic study follow by~     randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week~     period. This intervention will improve the volunteer's body composition and reduce their risk~     of developing diabetes.~      Extensive tests will be conducted before and after the dietary intervention using emerging~     technologies with current state-of-the-art methods. These tests will monitor the numerous~     physiological adaptations that have occurred on a gene, cell, organ and organismic level.~      The study will, therefore, aim for a scientific breakthrough by developing a series of novel~     biological markers that can accurately determine an individual's health status.~   "
143815|NCT01684904|"~     The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a~     regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal~     proton modality, followed by definitive surgery. In most combined-modality trials to date,~     chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil.~      In designing the regimen, the investigators attempt to improve on the standard~     cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the~     regimen. This agent has activity against advanced esophageal cancer and is also a potent~     radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in~     reduced toxicity of various combination regimens similar to that used by CROSS trial and~     allows for easier administration in the outpatient setting.4 Third, for localized esophageal~     cancer, dose distribution patterns achievable with proton beam could potentially offer~     important clinical advantages relative to those achievable with x-rays (photons).19 Based on~     this, the investigators believe that this study should be conducted with the radiation~     modality that offers the best dosimetry achievable at our institution.~   "
143816|NCT01684891|"~     This is a single-center, open label, multiple dose study to investigate the pharmacokinetics~     of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of~     [13C]-labeled IV microdoses and an oral [14C]-labeled dose of RG1662 in healthy male~     volunteers. The anticipated time of study treatment is 4 weeks.~   "
143817|NCT01684878|"~     This two-part, multicenter study will evaluate the safety, tolerability and efficacy of~     pertuzumab in combination with standard chemotherapy in women with recurrent~     platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in,~     participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized,~     double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in~     combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).~   "
143818|NCT01684865|"~     This prospective observational study will evaluate the safety and efficacy of first-line~     rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma.~     Participants initiated on rituximab maintenance therapy according to the standard of care and~     in line with the current summary of product characteristics will be followed for a maximum of~     3 years or until disease progression occurs.~   "
143819|NCT01684852|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall~     be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product~     according to the instructions for use six times daily in both eyes over a period of 28 days.~     Response to treatment is recorded at day 28.~   "
143820|NCT01684839|"~     Neuroma excision and digital nerve reconstruction remain the best option for the treatment of~     Painful Digital Neuroma (PDN). When the distal nerve end is preserved, conventional~     nonvascularized nerve grafting is the primary option to bridge the defect. The investigators~     hypothesize the pedicled nerve flap taken from the dorsal branch of the homolateral digital~     nerve is better than conventional methods for reconstruction of the digital nerve defect~     after painful neuroma resection.~      This study reports treatment of painful digital neuroma using a pedicled nerve flap taken~     from the dorsal branch of homolateral digital nerve. From May 2007 to March 2010, the~     patients had previous nerve injuries with or without nerve repair. The mechanisms of injury~     include sharp cut, avulsion and crush. The defects were between the middle of the distal~     phalanx and the palmar digital crease.~   "
143821|NCT01684826|"~     ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise~     reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose~     significantly. This is realized by anatomy-specific optimization of the full acquisition~     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing~     engine) for every clinical task individually. Furthermore, smaller focal spot sizes and~     shorter pulses are used, which are known to positively influence image quality . The final~     effect on the clinical image quality is investigated in this study.~   "
143822|NCT01684813|"~     The purpose of this study is to determine if, in type 2 diabetic patients undergoing~     treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading~     dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of~     75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at~     24-36 hours of treatment.~   "
143823|NCT01684800|"~     The purpose of the study is to investigate the efficacy and safety of two different dose~     levels of desmopressin orally disintegrating tablets against placebo for the treatment of~     nocturia in adult women during 12 weeks treatment~   "
143824|NCT01684787|"~     In the current practice patients with normal levels of ALT were not treated. However, a~     percentage of patients will present an advanced grade of fibrosis and cirrhosis.~      Another reason to treat is the similar response to the treatment than elevated ALT patients~     published recently in mono-infected patients.~      The investigators have not data concerning the evolution and response to the treatment in~     co-infected patients with normal ALT.~      In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it~     assumes a behavior similar between mono and co-infected patients and the results are~     different.~      In the case of normal ALT the investigators do not know if the natural history in co-infected~     patients is similar than the mono-infected patients, and also the response of the treatment.~      This study prospective and controls is the answer of this question. The main hypothesis is if~     the response of treatment in co-infected patients is not inferior than mono-infected~     patients.~      The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin~     in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE~     (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning~     genotype, gender and hospital.~   "
143825|NCT01684774|"~     The investigators will be comparing ultrasound-guided (USG) ankle block and anatomic~     landmark-guided (ALG) ankle block to determine which of these procedures is better in~     surgical anesthesia and in postoperative pain relief.~   "
143826|NCT01684761|"~     The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell~     Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis~     (SPMS).~   "
143827|NCT01684748|"~     Overweight and obesity, which afflicts ~65% of the U.S. population and more than 1 billion~     people worldwide, increases the risk of developing hypertension. Activation of the renin~     angiotensin system (RAS) is an important mechanism by which obesity leads to hypertension. In~     addition to its vasoconstricting and sodium retaining actions, angiotensin II also has potent~     pro-inflammatory actions including macrophage infiltration and expression of proinflammatory~     cytokines in target tissues. Adipose tissue and skeletal muscle appear to be a key sites for~     the generation of proinflammatory cytokines. Although angiotensin II receptor blockade~     reduces inflammation in many tissues, the effects on adipose tissue and skeletal muscle in~     humans are not clear. Importantly, the chronic low grade inflammatory state that accompanies~     obesity complicates hypertension by contributing to insulin resistance and accelerating~     cardiovascular disease. Therefore, the general aim of the present proposal will be to~     determine the influence of angiotensin II receptor blockade on adipose tissue and skeletal~     muscle inflammation and its relation to improvements in insulin sensitivity, if observed, in~     obese hypertensive humans. To address these aims, 44 obese (BMI>30 kg/m2) hypertensive~     (BP>140 systolic and/or 90 diastolic) individuals (age=50-65 years) will be randomized to~     receive 8 weeks of either the angiotensin II receptor antagonist, olmesartan medoxomil, or no~     treatment in a crossover manner. Subcutaneous adipose tissue and skeletal muscle biopsies~     will be obtained and insulin sensitivity (intravenous glucose tolerance tests) will be~     assessed at baseline and following 8 weeks of each intervention. A two week washout period~     will separate the interventions.~   "
143828|NCT01684735|"~     Evaluation of the response to chemotherapy in breast cancer patients by the use of~     Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy,~     after one and 3 cycles of therapy and at the end of the therapy.~   "
143829|NCT01684722|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among participants in VITAL with a history~     of diabetes and will examine whether vitamin D or fish oil prevents the development and~     progression of diabetic kidney disease.~   "
143830|NCT01684709|"~     This study compares the medical and psychological effects of telemonitoring plus intensified~     self-management support to those of usual care alone for patients with poorly controlled type~     2 diabetes mellitus (DM). If this intervention proves effective without increasing costs or~     clinician burden, then its implementation could yield major public health benefits,~     especially for vulnerable and underserved DM patients, and broader societal benefit may occur~     through increased helping behavior and strengthened social ties.~   "
143831|NCT01684696|"~     Lung cancer is the leading cause of cancer death in both men and women. Lung cancer is unique~     because of racial disparity, persistent mortality rate, and social stigma. Lung cancer stigma~     (LCS) and difficult patient-clinician communication may be an underlying factor in health~     disparities in lung cancer. The purpose of this study is to PILOT test, in a diverse sample~     of lung cancer patients the effectiveness of the mHealth Tool for Lung Cancer patients~     (mHealthTLC), an interactive, immersive 3-dimensional iPad application that allows~     individuals to experience first person virtual visits with their clinicians, to improve~     patient-clinician communication, decrease LCS, and promote optimal self-management. The study~     hypotheses are that patients who receive the mHealth TLC will improve their ability to~     communicate effectively with their clinicians and will report decreased stigma related to~     their lung cancer diagnosis compared to the attention control group.~   "
143832|NCT01684683|"~     Theophylline was well recommended in the treatment of chronic obstructive pulmonary disease~     (COPD) and asthma. However, there is no supporting evidence for their efficacy in the~     treatment of bronchiectasis. Our hypothesis is that theophylline will play a role in~     bronchiectasis. Our purpose is to examine the efficacy and safety of 24 weeks treatment with~     theophylline in subjects with non-cystic fibrosis bronchiectasis.~   "
143833|NCT01684670|"~     This research study is designed to investigate the feasibility and treatment effects of a~     behavioral speech treatment in adults and children with Down Syndrome (DS) and dysarthria.~     The speech sessions will provide an intensive, articulation-based intervention focused on~     increasing effort during speech production via use of clear speech. A single subject~     multiple baselines across subjects design will be employed in a total of six subjects divided~     into two groups of three. Changes in dependent measures will be determined by visual~     inspection, effect size determination, and time series analysis. The study follows accepted~     procedures in rehabilitation treatment and research and there are minimal foreseeable risks~     associated with participation.~   "
143835|NCT01684644|"~     The purpose of this study is to investigate the effectiveness of parent training in the~     treatment of ADHD in young children (ages 3-7) referred to Danish child mental health~     services. Medication is not recommended as first-line treatment for young children with ADHD.~     Parent training is recommended, but has not been formally introduced or established in~     Denmark. The study will investigate the effectiveness of a parent training programme~     specifically developed to target ADHD symptoms in young children; The New Forest Parenting~     Programme, against Treatment as Usual for children diagnosed with ADHD at two different child~     mental health clinics in Denmark.~   "
143836|NCT01684631|"~     The objective is to evaluate the implant survival rate for patients implanted with a~     PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the~     treatment of a severe hip disease and true femoral cervical fracture.~   "
143837|NCT01684618|"~     -  Due to the increased risk of brain damage, continuous monitoring of the cerebral~          oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to~          detect induced changes in the cerebral regional saturation.~        -  The purpose of the study is to investigate our hypothesis that a particular CPAP flow~          pressure optimizes the regional cerebral oxygenation.~   "
143838|NCT01684605|"~     The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after~     IV administration in health male volunteers~   "
143839|NCT01684592|"~     Smoking is a leading cause of death and other negative health outcomes. While a high~     percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months~     postpartum. We propose developing and pilot testing a phone-based postpartum continuing care~     (PPCC) protocol based on existing evidence-based approaches to increase smoking cessation,~     reduce relapse, increase early re-intervention, and reduce infant exposure to environmental~     tobacco smoke in the postpartum period.~   "
143840|NCT01684579|"~     Recent studies have shown that some behavioral factors such as physical activity and exercise~     may improve quality of life and outcome in patients with breast cancer as well as decrease~     body fat, increase lean mass and reduce cancer-promoting hormones. None of these studies have~     been performed in African-American women with breast cancer. The medical field needs to~     understand how exercise may benefit cancer patients, particularly African Americans, and how~     to optimize these benefits to improve the quality of life, prognosis and survival.~   "
143841|NCT01684566|"~     To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral~     mucositis in patients receiving conditioning treatment for hematopoietic stem cell~     transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral~     mucositis scores defined by the World Health Organisation (WHO) oral toxicity scale assessed~     daily by the investigator over the 28-day study period.~   "
143842|NCT01684553|"~     It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and~     lesser feelings of hunger and desire to eat and higher levels of fullness after the meal~     compared to eating the same meal more quickly.~   "
143843|NCT01684540|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray. In addition~     the effectiveness and safety shall be compared to a Sinupret forte. The patient applies~     Ectoin® Rhinitis Nasal Spray or takes Sinupret forte according to the instructions for use.~     The observation takes place over a period of 14 days. Response to treatment is recorded at~     day 7 and day 14 by the physician and in daily by the patient in a dairy.~   "
143844|NCT01684527|"~     The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence~     the population of lung immature myeloid cells and dendritic cells in a way that will impair~     their ability to invoke an effective immune response and lead to prolonged inflammation,~     angiogenesis and scarring. This may lead in turn to disturbed lung function.~      Our aim is to determine the presence and phenotype of immature myeloid cells present in~     respiratory secretions of children with RSV bronchiolitis as compared to non-RSV~     bronchiolitis and healthy controls.~   "
143845|NCT01684514|"~     Confocal laser endomicroscopy (CLE) is a novel method in evaluation of microscopic structures~     in vivo. The examination is carried out with a confocal laser endomicroscope, which is either~     part of the endoscope (manufactured by Pentax) or probe based (manufactured by Cellvizio).~     Hereby, all parts of the gastrointestinal (GI) tract can be examined. The method has~     potential to replace conventional microscopy and the dynamic nature of the procedure allows~     visualization of structures and cellular processes in almost real-time. This provides us with~     a potentially new diagnostic tool with a promising future. To date only a few studies have~     been published on inflammatory bowel disease (IBD) and in the literature high-quality~     research is still lacking.~      The project consists of a blinded prospective observation and methodology study including~     inter- and intra-observation of patients with proctitis before and after initiation of local~     treatment.~      Hypothesis: CLE can be used to assess the degree and extend of acute and chronic inflammation~     and treatment response in patients with ulcerative colitis and is a sensitive supplementary~     to conventional diagnostics.~   "
143846|NCT01684501|"~     The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot~     and evaluate if it provides a physiological generation of power at the ankle in transtibial~     amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e.~     robotic system).~   "
143847|NCT01684488|"~     The research will first examine data obtained from YRI participants to investigate effects of~     the group sessions on psychosocial and functioning outcomes in youth.~      In pursuit of this aim, this research will investigate the following hypothesis:~     Participation in the Youth Readiness Intervention will reduce symptoms of internalizing,~     externalizing, trauma-related symptoms, and improve prosocial skills and functioning among~     war-affected 15-24 year olds in Sierra Leone.~      The research also intends to examine whether youth enrolled in a psychosocial Youth~     Readiness Intervention (YRI) and a complementary education program fare better than an~     education-only control group, a psychosocial-only control group, and a waitlist control~     group.~      In pursuit of this second aim, this research will investigate the following hypothesis: A~     combined psychosocial-education program is an effective paradigm for improving psychosocial,~     functional, educational, and economic self-sufficiency outcomes among war-affected youth.~   "
143848|NCT01684475|"~     The purpose of this study is to assess the ability of CJH1 to increase the sensitivity of~     dopamine receptors and thereby reduce symptoms of Parkinson's Disease.~   "
143850|NCT01684449|"~     The soft tissue sarcomas (STS) constitute an infrequent group of malignant neoplasms of~     mesenchymal origin. In Spain, the approximate incidence is of 2 new cases per 100.000~     inhabitants every year. In patients with metastatic STS, the average survival is very short,~     approximately 12 months. The systemic treatment of the metastatic disease has had a very~     limited development, with few satisfactory results. This facts reflect the urgent need to~     identify new active agents for treatment of these patients.~      The molecular pathway of the serine/threonine kinase mammalian target of rapamycin (mTOR)~     plays a central role in the regulation of the proteins translation, cellular growth and~     metabolism (Meric-Bernstam F et al. 2009). Currently, the mTOR pathway is considered a~     relevant target for the development of anti-cancer drugs, as rapamycin. Preliminary results~     of some clinical trials suggest that mTOR inhibitors could have some clinical activity for~     different types of sarcoma, including STS (Chawla et al Proc.ASCO 2006; Schuetze et al.~     Proc.ASCO 2006).~      Gemcitabine is a chemotherapy antimetabolite agent with a broad antitumoral spectrum. The~     activity of this drug to treat resistant sarcomas and its reduced toxicity make from~     gemcitabine an adequate candidate for its study in combination with new drugs addressed to~     molecular targets in the STS treatment.~      Pre-clinical studies suggest that mTOR inhibitors could have a potential synergistic or~     additive effect with some chemotherapy agents. The combination of rapamycin and gemcitabine~     seems to be a reasonable strategy to explore for the STS treatment.~   "
143851|NCT01684436|"~     This study will access changes in tear protein levels and symptoms of dry eye following~     insertion of a punctal plug.~   "
143852|NCT01684423|"~     The purpose of this study is to find out whether rivaroxaban is safe to use in children and~     how long it stays in the body. There will also be a check for bleeding and worsening of blood~     clots.~   "
143853|NCT01684410|"~     This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the~     safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day~     for three weeks in subjects aged 18 years and older with cystic fibrosis (CF). The treatment~     duration in this study was intended to provide multi-dose safety information prior to~     proceeding to longer durations of exposure.~   "
143854|NCT01684397|"~     This phase I/II trial studies the side effects and best dose of pazopanib hydrochloride and~     bevacizumab and to see how well they work in treating patients with previously untreated~     kidney cancer that has spread to other places in the body (metastatic). Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by blocking~     blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can prevent tumor growth~     by blocking the ability of tumor cells to grow and spread. Giving pazopanib hydrochloride~     together with bevacizumab may kill more tumor cells.~   "
143855|NCT01684384|"~     In this study the consequences of exacerbations will be visualized by high resolution~     computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity~     (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based~     airway dimensions and computational fluid dynamic (CFD) -based resistance values will be~     correlated with changes in patient reported outcomes (PROs) and lung function tests recorded~     at the same time.~   "
143856|NCT01684371|"~     The treatment of osteoarthritis, a disease that eventually affects the majority of the older~     population, involves the alleviation of symptoms such as pain and stiffness, and the~     reduction of inflammation. A double-blind, placebo-controlled, crossover study will be~     performed to examine the effect of topical application of Elmore Oil, a herbal remedy~     (containing Eucalyptus oil, Tea tree oil, Olive oil and Vanilla), which has recently been~     reported to have anti-inflammatory properties, on the symptoms of osteoarthritis.~   "
143857|NCT01684358|"~     This unblinded, randomized controlled trial (RCT) among women to determine:~      1)if unprotected sex as measured prostate-specific antigen (PSA) will be more among women who~     receive a contraceptive implant immediately at baseline during three months of follow up~     compared to women who receive the implant at the three month follow-up visit.~   "
143858|NCT01684345|"~     The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of~     active non-infectious intermediate, posterior, or pan- uveitis.~   "
143859|NCT01684332|"~     The aim of this study is to investigate the effects of an acute intake of three different~     types of strawberry jam, differing in the carbohydrates and antioxidants content, on~     postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in~     healthy adults.~   "
143860|NCT01684319|"~     Various digestive manifestations are common in infants less than 6 months and have a~     significant impact on morbidity and quality of life of the family. In a prospective study on~     more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of~     these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%),~     constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate,~     and their cause is often difficult to determine. Frequently, the pediatrician will exclude~     cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked.~     This measure causes significant additional costs through the use of extensively hydrolyzed~     milk specifically for children and involves an elimination diet of all foods containing cow's~     milk sometimes for several years. This can negatively influence the growth of the child.~      If the involvement of milk in these pathologies is suggested by some early studies (35% for~     colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current~     state of knowledge if these gastrointestinal symptoms are actually due to an allergy to~     milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy.~     However, various tests have proven their effectiveness in the investigation of non~     IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.~   "
143861|NCT01684306|"~     There is growing debate on the use of drugs that can promote cognitive enhancement.~     Amphetamine-like drugs have been employed as cognitive enhancers, but all of them have~     important side effects and may induce addiction. In our study, we will investigate the use of~     modafinil which, in recent years, has been proposed as cognitive enhancer. Modafinil appears~     to have less side effects compared to amphetamine-like drugs and we will analyzed whether the~     drug can influence cognitive performances and the brain resting state network activity of~     healthy young subjects.~   "
143862|NCT01684293|"~     This study integrates a model of occupational-therapy based cognitive rehabilitation as part~     of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive~     impairment and quality of life would improve and that cocaine use would decrease in those~     participants receiving occupational-therapy based cognitive rehabilitation.~   "
143863|NCT01684280|"~     To investigate:~        1. Associations between miRNA and insulin signaling-related gene expressions in abdominal~          adipose tissues in obese subjects.~        2. Differences in miRNAs expressed by intrabdominal omental adipose tissues between~          genders.~   "
143864|NCT01684267|"~     To test the usability and effectiveness of a robotic device, called the Robotic Gait~     Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2)~     patients with stroke with gait abnormalities secondary to impaired knee function.~   "
143865|NCT01684254|"~     The present project will focus on evaluating the technical efficacy of the in-shoe gait~     monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of~     children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.~   "
143866|NCT01684241|"~     Clinical first-in-human dose escalation study evaluating the safety and tolerability of~     intranodal administration of an RNA-based cancer vaccine targeting two tumor-associated~     antigens in patients with advanced melanoma~   "
143867|NCT01684228|"~     End stage renal disease (ESRD) is a severe clinical state of irreversible loss of endogenous~     kidney function, shortening life expectancy, if left untreated. In the state of ESRD, over~     5000 uremic toxins are accumulated in the body causing dysfunction of various organ systems.~     The survival of these patients depends on renal replacement therapies, such as hemodialysis~     (HD), which artificially purifies the blood from toxins. The investigators assume that some~     of the uremic toxins are also present in the patient's exhaled breath, and could be detected~     by a non-invasive and highly sensitive test: a NA-NOSE artificial olfactory system. It is~     based on analysis of volatile organic compounds (VOCs), a novel, non-invasive field in~     medical diagnostics. The NA-NOSE is made from an array of nanosensors, and was developed by~     our collaborator Dr. Hossam Haick (Chemical Engineering, Technion).~      In the current study, the investigators utilize this technology to identify VOCs in the~     exhaled breath of dialysis patients, and to characterize certain patterns of expression that~     could potentially help in future monitoring of HD adequacy. The investigators plan to collect~     150 breath samples from patients before and during dialysis, and from healthy subjects. All~     participants provide a signed informed consent. Subsequently, analysis of samples will be~     done at Dr. Haick's laboratory, using Gas-Chromatography/Mass-Spectrometry and parameters~     extracted from each sensor response.~   "
143868|NCT01684215|"~     This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1~     portion is a single-country, non-randomized, open label, clinical trial which will evaluate~     the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a single~     agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination with~     letrozole in the first-line treatment of Japanese patients with ER(+) HER2(-) ABC. The Phase~     2 portion is a single-country, non-randomized, open-label, single-cohort, multi-center~     clinical trial to evaluate the efficacy and safety of PD-0332991 in combination with~     letrozole for the first-line treatment of postmenopausal Japanese patients with ER(+) HER2(-)~     ABC.~   "
143869|NCT01684202|"~     OPC-41061 will be administered to patients with volume overload associated with cancer, first~     by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine~     volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic effects, and~     safety and to determine the effective initial and maintenance doses of OPC-41061.~   "
143870|NCT01684189|"~     Objectives：~        1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile~          episodes in patients receiving chemotherapy~        2. To explore the percentage/distribution of infectious origins of febrile neutropenia~        3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia~        4. To explore clinical outcomes of different infectious origins/pathogens in febrile~          neutropenia episodes~        5. To have a clear view of therapeutic actions in the management of hematological patients~          with febrile neutropenia and suspected fungal-related febrile episodes~   "
143871|NCT01684176|"~     Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk~     of a new stroke, however, poor adherence to secondary prevention medications occurs~     frequently within this patient group. The purpose of this study is to evaluate whether a~     complex tailored pharmacist intervention will lead to increased adherence to secondary stroke~     prevention medications and less new stroke events when compared to a usual care group.~     Interventions focus on motivational interviewing, medication review and telephone follow up.~   "
143872|NCT01684163|"~     GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major~     depressive disorder (depression) who have responded inadequately to another antidepressant~     drug during the current episode. This trial will assess the effects of GLYX-13 on depression~     when added to another antidepressant drug that the patient is already taking.~   "
143873|NCT01684150|"~     The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety~     of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary~     assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias bearing~     rearrangements of the MLL gene.~      Currently this study is in the MLL-r restricted/expansion phase and is only enrolling~     patients with rearrangements involving the MLL gene, including 11q23 or partial tandem~     duplications (PTD).~   "
143874|NCT01684137|"~     Reduction of the total IgE antibody, improved vital capacity and lung volume measured by~     spirometry.~      Improving quality of life observed in the visual analogue scale (VAS).~   "
143875|NCT01684124|"~     The investigators hypothesize that it is feasible and safe to deliver a conservative approach~     to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on~     average,10 days).~   "
143876|NCT01684111|"~     To investigate the maximum tolerated dose of BIBF 1120, safety and pharmacokinetics in~     escalating doses administered with Vinorelbine i.v. in elderly patients with advanced~     Non-Small Lung Cancer (Stage IV).~   "
143877|NCT01684098|"~     The folate receptor is over-expressed on many types of cancer cells and new folate receptor~     targeted therapies are being developed to target cancer cells that over-express the folate~     receptor. As with other targeted therapies, it is important to develop diagnostic tests that~     will provide accurate information on folate receptor status and aid in selecting patients~     that may benefit from folate-targeted therapy.~   "
143878|NCT01684085|"~     This study is designed to test the effect of an explanation about the first sleep following~     trauma exposure, on the development of Post Traumatic Stress Disorder (PTSD) in the months~     following the traumatic event.~   "
143879|NCT01684072|"~     The purpose of this study is to observe the occurrence of adverse reaction and antibody~     positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of~     live attenuated varicella vaccine without gelatin.~   "
143880|NCT01684059|"~     The ability of spermatozoa to produce reactive oxygen species (ROS) has been respected since~     the 1940's. Oxidative stress limits the functional competence of mammalian spermatozoa via~     lipid peroxidation, the induction of oxidative DNA damage and the formation of protein~     adducts. Nitric oxide (NO) is a free radical generated from the oxidation of L-arginine to~     L-citrulline by reduced nicotinamide adenine dinucleotide phosphate (NADPH)-dependent NO~     synthases. Several studies suggest that the overproduction of this free radical and the~     subsequent excessive exposure to oxidative conditions have a potential pathogenetic~     implication, which due to the reduction of sperm motility. The present study was conducted to~     study the effect of Zn supplementation on the levels of NO synthase and arginase in semen of~     patients with asthenozoospmia.~   "
143881|NCT01684046|"~     The purpose of this study was to evaluate the performance of Opti-Free® PureMoist®~     Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand~     name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.~   "
143882|NCT01684033|"~     The purpose of this study was to evaluate the performance of Opti-Free® PureMoist®~     Multi-Purpose Disinfecting Solution (MPDS) compared to Biotrue™ Multipurpose Solution (MPS)~     in silicone hydrogel contact lens wearers.~   "
143883|NCT01684020|"~     Rhinoplasty (nasal reconstruction i.e. a nose job) is a surgical procedure performed on the~     nose to correct a medical problem or change the appearance of the nose. During the healing~     process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may~     or may not lessen these effects. This study is looking to see the effects of ARTISS on~     adhering tissue and improving wound healing in an external rhinoplasty. The purpose of this~     study is to evaluate the safety and effectiveness of rhinoplasty using ARTISS compared to~     rhinoplasty without using ARTISS in patients undergoing rhinoplasty performed through an~     external approach.~   "
143884|NCT01684007|"~     The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both~     eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant~     eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral~     implantation) at Month 3 following the second eye surgery.~   "
143885|NCT01683994|"~     Background:~      - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is~     approved for medullary thyroid cancer. However, studies have shown that prostate tumors~     respond to it. Docetaxel and prednisone are standard treatments for advanced prostate cancer.~     Researchers want see if adding cabozantinib to these two drugs can be a safe and effective~     treatment for this type of cancer.~      Objectives:~      - To test the safety and effectiveness of cabozantinib with standard treatments for advanced~     prostate cancer.~      Eligibility:~      - Individuals at least 18 years of age who have advanced prostate cancer that has not~     responded to standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will also be performed.~        -  Participants will receive the cancer drugs over 21-day cycles of treatment. They will~          take docetaxel and cabozantinib on day 1 of each cycle. Each docetaxel infusion will~          take about 1 hour. They will also take prednisone by mouth twice each day.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the study drugs for as long as their cancer does not~          worsen and side effects are not too severe.~   "
143886|NCT01683981|"~     Due to vasodilatory properties of the NO, one of the therapeutic approaches for IPAH is oral~     use of nitric oxide precursors (10). Efficacy of L-arginine is well-documented in the current~     literature but there is paucity of data with regard to L-citrulline- malate. Hence, this~     study will evaluate therapeutic efficacy of L-citrulline- malate in two categories of~     patients with pulmonary hypertension (IPAH, and Eisenmeger syndrome). This randomized~     clinical trial utilizes 6-minute walk, pro BNP levels and the echocardiographic indexes an~     indicator of functional improvement of the patients.~   "
143887|NCT01683968|"~     This study is designed to investigate the presence and absence of abnormal heart muscle~     contractions during sickle cell crises.~      You will be asked to do echocardiography during and after your admission to the hospital. We~     will compare tow pictures and study the differences.~   "
143888|NCT01683955|"~     This study aims to assess postoperative blood loss and transfusion rates in total hip~     replacement after one-time administration of topical tranexamic acid.~   "
143889|NCT01683942|"~     Development of a novel computer software that will assist in measuring the cup/disc ratio in~     digital stereo optic disc images.~   "
143890|NCT01683929|"~     The goal of this study is to determine the hormonal/metabolic reponse to ingestion of sugar~     compared to consuming artificial sweetened drink, and to evalute macronutrient consumption 24~     hours post ingestion of the drinks.~      We hypothesize that artificially sweetened (AS) consumption will lead to a relatively similar~     hormonal/metabolic responses as glucose consumption and therefore to secondary rise of~     caloric intake.~   "
143891|NCT01683916|"~     Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses.~     Anesthetic requirements and stress hormone response are compared in SCI patients undergoing~     anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or~     remifentanil.~   "
144055|NCT01681771|"~     The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term~     effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on~     depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in~     patients with chronic heart failure and depression.~   "
143892|NCT01683903|"~     Treatment of chronic heart failure requires multidisciplinary approaches with a recognized~     role for cardiac rehabilitation. Rehabilitation helps to improve patient's functional,~     decrease morbidity and mortality, decrease rehospitalization rate, thereby reducing costs of~     this disease. After recovery from the acute phase of cardiac infarction, patients admitted to~     the rehabilitation center will follow the usual rehabilitation program during the~     hospitalization period. This step precludes outpatient follow-up period in our day hospital,~     in accordance with their physicians and cardiologists who manage the monitoring. The study~     INCARD (Insuffisance Cardiaque en Readaptation Durable) will be developed to evaluate the~     benefits of a sustainable rehabilitation heart failure on patients treated optimally and~     educated during a follow-up period of 24 months. The main objective of the study will be to~     compare the benefits of rehabilitation between coronary (C) and non-coronary (NC) patients~     for each evaluation time point, periodically recorded~   "
143893|NCT01683890|"~     To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring~     after simple hysterectomy and to analyze the influence of bladder symptoms and sexual~     function change on quality of life of patients.~   "
143894|NCT01683877|"~     To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian~     function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy~   "
143895|NCT01683864|"~     Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer~   "
143896|NCT01683851|"~     Hypothesis~      The use of Isolite® system does not produce upper airway obstruction in the pediatric~     population during dental treatment with conscious sedation.~      Purpose:~      Report the changes in airway patency and pediatric patient's behavior when Isolite® system is~     used for dental treatment with conscious sedation.~      Objectives:~        1. Determine changes in pulse rate~        2. Determine changes in SpO2~        3. Recognize breath sound's changes possibly associated with airway blockage~        4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental~          treatment under conscious sedation~        5. Relate the use of Isolite® with the frequency of head reposition to open the airway.~   "
143897|NCT01683838|"~     Normally, nerve fibers carry electrical impulses through the spinal cord, providing~     communication between the brain and the arms and legs. In people with spinal cord injury,~     some fibers may be destroyed at the site of injury, while others remain connected but do not~     work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal~     cord injury may have spasticity which is muscle spasms or muscle stiffness that makes~     movement difficult. Fampridine-SR is an experimental drug that increases the ability of the~     nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on~     moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as~     bladder control, bowel function and sexual function. The study will also examine the possible~     risks of taking Fampridine-SR.~   "
143898|NCT01683825|"~     The primary aim of this pilot study is to determine whether amyloid deposits in the heart can~     be measured non-invasively by F-18 florbetapir (Trade Name: Amyvid) positron emission~     tomography (PET) in 30 individuals with documented cardiac amyloidosis. We will also enroll~     15 individuals without cardiac amyloidosis to undergo the F-18 florbetapir imaging as a~     control group.~      The primary hypothesis of this study is that a specific amyloid binding radiotracer will bind~     to the myocardial amyloid deposits and help quantify cardiac amyloid burden.~      A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of~     the myocardium.~   "
143899|NCT01683812|"~     The purpose of this descriptive study is to provide information on the feasibility of using~     the cranial cup, a new positioning device, in a small sample of prematurely born infants with~     elongated head shapes as a result of laying on their abdomens, during the convalescent phase~     of their hospitalizations.~   "
143900|NCT01683799|"~     The purpose if the study is to determine whether improving sleep, especially slow wave or~     deep sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity~     and inflammatory responses to pain, and improves OA-related pain.~   "
143901|NCT01683786|"~     Purpose:~      To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment~     for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with~     undetectable HCV RNA at wk 8.~      Study Design:~      a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype~     1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (<50 IU/ml)~     will be recruited into 2 arms(30 in each arm). Patients must receive pegylated interferon-α2b~     at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before entering~     this study.~   "
143902|NCT01683773|"~     This trial will investigate the administration of two new tuberculosis vaccines, called~     AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these~     vaccines are given one after the other. The trial will assess the safety of both vaccines and~     also their ability to stimulate an immune response within the body. It is hoped that when~     these two vaccines are given in sequence, the combined immune response is even better than~     when each vaccine is used individually.~   "
143903|NCT01683760|"~     The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used~     as prophylaxis of invasive fungal infection in premature infants.~   "
143904|NCT01683747|"~     The premise of this study is that enteral tranexamic acid will help to maintain small bowel~     integrity, which is often compromised by critical illness due to inadequate cardiovascular~     perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease~     morbidity in critically ill patients.~   "
143905|NCT01683734|"~     The purpose of this study is to monitor the renal function of patients who have an antibiotic~     laden spacer in place to treat an infected hip or knee arthroplasty.~   "
143906|NCT01683721|"~     The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System~     in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).~   "
143907|NCT01683708|"~     The aim of the present study was therefore to evaluate if the perioperative administration of~     symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for~     hepato-biliary and pancreatic surgery.~   "
143908|NCT01683695|"~     This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose~     study that will enroll approximately 40 systemic lupus erythematosus subjects with active~     lupus arthritis.~   "
143910|NCT01683669|"~     Noisy Pressure Support Ventilation (noisy-PSV) would lead to improved lung function, while~     preserving respiratory muscle unloading. Basically, noisy PSV differs from other assisted~     mechanical ventilation modes that may also increase the variability of the respiratory~     pattern (e.g. proportional assist ventilation) by the fact that the variability does not~     depend on changes in the patient's inspiratory efforts.~      The aim of this study is to evaluate the optimal variability for noisy PSV in patients with~     ALI based on its effects on respiratory mechanics, breathing comfort, gas exchange, and~     hemodynamics. The investigators hypothesize that noise in pressure support leads to~     variations in VT that are able to improve lung function and that physiologic variables~     respond differently to the degree of variability in pressure support~   "
143911|NCT01683656|"~     HIV-infected patients are at increased risk for cardiovascular disease. Large investigations~     support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a~     treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only~     through its benefit in terms of lipid profile, but also by reducing atherosclerotic~     inflammation.~      The study aims at showing that a therapy targeting HDL-C increase in HIV-infected patients on~     suppressive cART has the potential for reducing subclinical atherosclerotic inflammation~     associated with HIV itself in HIV-individuals on cART.~      NILACH is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to test~     the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness (IMT)~     in 90 subjects.~        -  Regimen 1: ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5~          to the end of the study (the titration aims to reduce adverse reactions)~        -  Regimen 2: ER niacin/laropiprant placebo p.m.~      The primary end point is the change in mean common carotid intima-media thickness from~     baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group.~      The proposed in vivo experiments should provide insights on the potential benefits of niacin~     treatment of cardiovascular disease in HIV patients. In addition, we will be able to further~     clarify the role of systemic inflammatory mediators in the development of early~     atherosclerosis of HIV-infected patients on antiretroviral therapy. Detection and treatment~     of non-infectious co-morbidities such as cardiovascular diseases have become essential for~     HIV-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere~     management of opportunistic infections or virologic suppression.~   "
143912|NCT01683643|"~     The purpose of the study is to determine whether SBIRT is an effective intervention with~     inmates and to estimate the costs of providing SBIRT to this population.~   "
143913|NCT01683630|"~     This study compares the epidemiology and clinical outcomes of laboratory confirmed influenza~     type A to type B following clinical diagnosis of influenza. Multivariate models are used to~     assess the effects of influenza type on clinical outcomes while accounting for potential~     confounders.~   "
143914|NCT01683617|"~     Psychological stress occurs when an individual perceives that environmental demands tax or~     exceed his or her adaptive capacity. In this view, stressful experiences are conceptualized~     as person-environment transactions, whose result is dependent on the impact of the external~     stimulus. This is mediated by the person's appraisal of the significance of the stimulus, of~     the personal, social and cultural resources available and of the efficacy of the coping~     efforts.~      Extreme levels of stress can have a negative influence on one's professional life and can~     disrupt both the social and personal life of an individual. Stress can also cause different~     physiological and psychological disorders such as anxiety, chronic headaches, depression,~     withdrawal symptoms, nausea, phobias, blood pressure problems, heart impairments and others.~      Stress Management Therapy can help to overcome counter effects of stress. Usually various~     techniques are used including relaxation, interaction, biofeedback and Cognitive Behavior~     Therapy methods. According to the Cochrane Database of Systematic Reviews the best validated~     approach covering both stress management and stress treatment is the Cognitive Behavioral~     Therapy (CBT) approach.~      The trouble with stress is that it is very personal. Thus, stress-related disorders depend a~     great deal on how the person experiencing a stressor is put together —psychologically and~     physically. So the focus for assessment, prediction and treatment has to be the person's~     situated experience.~      To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new~     paradigm for e-health - Interreality - that integrates contextualized assessment and~     treatment within a hybrid environment, bridging physical and virtual world.~      From the clinical point of view the INTERSTRESS solution may offer the following innovations~     to current traditional protocols for stress management:~        -  Objective and quantitative assessment of user's stress level using biosensors and~          behavioral analysis;~        -  Provision of warnings and motivating feedbacks to improve self awareness, compliance and~          long term outcome;~        -  Decision Support System (DSS) for treatment planning through data fusion and detection~          algorithms.~   "
143915|NCT01683604|"~     This multi-center, observational study will evaluate the treatment patterns in clinical~     practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA)~     who have had an inadequate response (or were intolerant to) treatment with non-biological~     disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be~     collected from each eligible participant initiated on tocilizumab treatment by their treating~     physician according to approved label for 6 months from start of treatment.~   "
143916|NCT01683591|"~     Dysphagia occurs relatively commonly in patients with acute stroke, and can lead to~     aspiration pneumonia and malnutrition. By using the stroke registry of our hospital, we will~     evaluate the feasibility and usefulness of Dysphagia screening in Acute Stroke using~     High-resolution impedance manometry (DASH). The hypothesis tested in this study is that~     high-resolution impedance manometry (HRiM) can provide the clinical efficacy to evaluate~     dysphagia and the diet plan in acute stroke patients.~   "
143917|NCT01683578|"~     Variable ventilation has been shown to improve lung function and reduce lung damage as well~     as inflammation in different models of the acute respiratory distress syndrome. Also,~     variable ventilation is able to recruit lungs. The present study will investigate whether~     variable as compared to non-variable ventilation improves post-operative lung function and~     reduces systemic inflammation in patients submitted to open abdominal surgery.~   "
143918|NCT01683565|"~     The purpose of this study is to examine whether supplementation with certain polyunsaturated~     fatty acids can help development and behavior of children born preterm.~   "
143919|NCT01683552|"~     Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine~     kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the~     effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological~     therapy-induced pruritus.~   "
144052|NCT01681810|"~     This research study is being conducted to examine the effects of daily inorganic nitrite~     treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese~     adults with the metabolic syndrome and high blood pressure. Ultimately, oral nitrite therapy~     may have a major impact on the prevention and treatment of both diabetes and cardiovascular~     disease.~   "
143920|NCT01683539|"~     This study is aimed at evaluating whether the computer-based cognitive exercises in the~     Thinking Skills for Work (TSW) program are critical to improving work and cognitive outcomes~     in consumers with serious mental illness and cognitive impairment enrolled in supported~     employment (SE), or whether a streamlined version of TSW without this component (the~     Cognitive Skills for Work (CSW) program) is equally effective for some or all consumers. An~     RCT will be conducted at two sites (Mental Health Center of Greater Manchester in New~     Hampshire and Thresholds Inc. in Illinois) with 244 consumers randomly assigned to one of two~     groups (122 each, with approximately 122 participants having schizophrenia or schizoaffective~     disorder and 122 of the participants having other diagnoses): 1) TSW, or 2) CSW. The TSW and~     CSW programs will be delivered by the same Cognitive Specialists, who will work as members of~     the SE team to integrate cognitive and vocational services. All participants will continue to~     receive SE services. Participants will be assessed at baseline, post-treatment at 8 months~     (after completion of the active teaching components of TSW or CSW), and at 16 and 24 months~     post-baseline to evaluate cognitive functioning, symptoms, and quality of life. All work~     outcomes will be tracked weekly.~      In addition, a supplementary study, commencing in September 2015, will assess a promising~     biomarker for understanding the mechanisms underlying the effects of cognitive remediation,~     brain-derived neurotrophic factor (BDNF), in new enrollees in the parent R01 study. This~     supplement will complement the aims of the parent R01 by shedding light on possible~     mechanisms related to how TSW works and for whom, thereby informing efforts to refine and~     improve the program, as well as targeting individuals who fail to benefit. The supplement~     will take place at the same sites as the parent R01.~   "
143921|NCT01683526|"~     The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent~     endotracheal intubation of critically-ill patients has not been well-described in the~     literature. This study will answer whether using a VL will impact on the efficacy and safety~     of intubation compared with a traditional direct laryngoscopy.~   "
143922|NCT01683513|"~     In this study the investigators compare the traditional way of triggering with a new way in~     patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper~     Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/~     ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and~     pregnancy rate.~   "
143923|NCT01683500|"~     Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The~     shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters~     are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers.~        -  Trial with medical device~   "
143924|NCT01683487|"~     I. To investigate time measurement from emergency room admission to first antibiotic~     administration.~      II. To evaluate risk factors for prolonged time to first antibiotic administration.~      III. To correlate time measurement with Charlson comorbidity index and multimorbidity~     patterns.~      IV. To investigate the impact of a delayed time to first antibiotic administration on the~     outcome~   "
143925|NCT01683474|"~     1. objectives~             -  Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by~               femoral artery~             -  Evaluate safety and clinical benefit of percutaneous implantation of the Venue~               MedTech aortic valve prosthesis.~             -  Continuous observe 12 months of safety and efficacy.~        2. Approximately 80 patients presenting with native aortic valve stenosis necessitating~          valve replacement which are considered unsuitable for Surgical Valve Replacement, with a~          high surgical risk, as attested to by both the surgeon and the cardiologist are~          recruited in the study.~        3. Safety and performance will be evaluated at discharge and at 30 days post procedure.~          Valve safety, performance and placement will be followed up at 6 and 12 months~          post-procedure.~   "
143926|NCT01683461|"~     This is a randomized controlled intervention trial with 1,500 pregnant and postpartum women~     to examine the efficacy of an enhanced model of ongoing post-test support for women attending~     antenatal and postnatal care in KwaZulu-Natal, South Africa. Through the intervention, the~     investigators will tailor voluntary counseling and testing (VCT) for HIV to the ANC setting~     and provide a continuum of psychosocial support for pregnant women through: (1) a~     standardized health education video before HIV pre-test counseling; (2) HIV pre- and~     post-test counseling sessions that prepare women for decisions related to testing, serostatus~     disclosure and anti-retroviral (ARV) prophylaxis and help women plan strategies for sexual~     risk behavior change; (3) two additional post-test counseling sessions postpartum focusing on~     legal education and referral, partner testing, sexual risk behavior change and family~     planning decisions and; (4) an active referral system to post-test support groups run by a~     clinically trained staff psychologist and (5) an active referral system to legal services run~     by a lawyer at the clinic.~      Through this intervention trial the investigators will be testing the following hypotheses:~      H1: Women receiving the intervention will have significantly lower sexual risk of HIV at 14~     weeks and 9-months post-partum as compared to women in the control arm. Sexual risk of HIV~     will be measured by: STI incidence (Trichomonas vaginalis, Neisseria gonorrhea and~     Chlamydia), consistent condom use, unprotected sex in past 30 days, and unprotected sex since~     delivery.~      H2: Women receiving the intervention will report significantly better outcomes related to~     prevention of mother to child transmission (PMTCT) service uptake at 14 weeks and 9 months~     post-partum as compared to women in the control arm. PMTCT service uptake will be measured by~     acceptance of HIV VCT among HIV-positive and HIV-negative women; acceptance of ARVs,~     adherence to national infant feeding guidelines, and family planning use among HIV-positive~     women.~      H3: Women in the intervention arm will report significantly better psychosocial outcomes at~     14 weeks and 9 months post-partum as compared to women in the control arm. Psychosocial~     outcomes will be measured by: perceived social support, emotional distress, and partner~     violence among HIV-positive and HIV-negative women.~   "
143927|NCT01683448|"~     This study will be a retrospective study. The patient data from the electronic medical~     records and existing database will be collected and analyzed. Primary endpoints will be~     postoperative mortality (within 30 days) and overall complications and length of hospital~     stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia,~     ischemia, stroke, neurological complications, length of ICU stay, re-admission rate,~     infections, pulmonary complications, length of intubation time, length of ventilation time,~     and acute renal failure.~   "
143928|NCT01683435|"~     We would like to determine if HBA® testing of sperm in couples with presumed idiopathic~     infertility will reveal lower binding percentages than in couples with an identifiable cause~     of infertility either male factor or tubal factor~   "
143929|NCT01683422|"~     The current trial will provide important data on the recurrence rates and patterns of failure~     using state of the art target agent, chemotherapy and proton beam technology for patients~     with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater~     would be considered evidence of a regimen potentially worthy of further study as a new~     treatment paradigm in one arm in a future phase III trial.~   "
143930|NCT01683409|"~     This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the~     treatment of participants with mild to moderate diabetic kidney disease.~   "
143931|NCT01683396|"~     The purpose of this proof-of-concept study is to determine whether gevokizumab is effective~     in the treatment of active inflammatory, erosive osteoarthritis of the hand.~   "
144053|NCT01681797|"~     The purpose of this study is to determine whether fluorescence angiography is an~     effectiveness technique for the localization of vascular perforators and their area of~     perfusion and for the postoperative monitoring of flap perfusion.~   "
144054|NCT01681784|"~     To determine the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations~     in diagnosing different urodynamic diagnoses.~   "
143932|NCT01683383|"~     Hypoxic ischemic encephalopathy (HIE) remains a major cause of death and severe disability~     despite advances in neonatal and perinatal medicine. Therapeutic hypothermia is the single~     most promising intervention for HIE. Reduction of brain temperature by 2° to 5°C has shown to~     be neuroprotective in newborn and adult animal models of brain ischemia. Therapeutic~     hypothermia instituted within 6 hours of birth has been shown to significantly improve~     survival and neurodevelopmental outcome in term newborns with HIE. Hypothermia is most~     effective if begun during the latent period, before the secondary energy failure. It is not~     known whether cooling initiated after 6 hours of age is effective.~      The goal of this proposal is to test the efficacy of the cooling device in achieving the~     target temperatures in patients with moderate to severe HIE during transport when compared~     with current practices.~   "
143933|NCT01683370|"~     STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values,~     emergency calls and consultations for fever, and on hospitalizations for FN in children and~     adolescents with cancer~        -  to describe the frequency of episodes of FN, and of other clinically relevant FN-related~          measures~        -  to compare these frequencies and measures in reality vs. applying Bernese standard~          limits for defining fever (ear temperature ≥39.0°C)~        -  to compare these frequencies and measures applying the Bernese standard limit of ≥39.0°C~          (LimitStandard) vs. a range of hypothetically lower limits defining fever (LimitLow)~        -  to determine if it would be useful to perform an interventional study on the question of~          different fever limits, powered to study both efficacy (frequency of FN) and safety (AE~          in delayed FN diagnosis)~        -  to use the platform of this prospective study to explore if the serum level of cortisol~          is associated with adverse events in FN~      HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions~     of fever from ear temperature 39.0°C to lower limits would~        -  increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint).~        -  increase the rate of other clinically important FN-related measures related to~          chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related~          measures during treatment of FN episodes diagnosed in reality (secondary endpoints~          4,5,6).~        -  not relevantly decrease the proportion of FN with AE (secondary endpoint 7).~   "
143934|NCT01683357|"~     It is not rare that two-stage hepatectomy for multiple bilobar colorectal liver metastases~     (CLM) be left incomplete because of disease progression or technical reasons. One-stage~     hepatectomy seems a feasible and safe alternative, however, long-term results are lacking.~     This study aims to provide evidence that one-stage hepatectomy compelling tumor exposure~     provides adequate long-term results with low risk of local recurrences.~   "
143935|NCT01683331|"~     Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in~     decreasing the incidence of NODAT among de novo kidney transplant patients with manifested~     post-transplant hyperglycemia during the first week after transplantation.~      Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress~     related to the surgery and use of higher doses of immunosuppressive medications, and leads to~     lower incidence of NODAT at 1 and 2 years.~      Specific Aim 2: To determine the improvement in overall glycemic control with the early~     initiation of insulin therapy.~      Hypothesis 2: Early initiation of insulin therapy results in greater overall control of~     glycemia compared to standard care of dietary counseling, life-style modification, oral~     hypoglycemic agents and/or insulin as needed at 1 year.~      Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to~     the early initiation of insulin therapy at one year post-transplantation.~      Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of~     post-transplant hyperglycemia and preserves better beta-cell function at 1 year.~   "
143936|NCT01683318|"~     The current study aims to test the efficacy of treatment for a device that utilises a thermal~     pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in~     patients suffering from meibomian gland dysfunction.~      Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators~     will monitor them for changes in tear film and lipid composition, as well as changes in the~     anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye~     symptoms will be documented in form of questionnaires.~      The investigators hypothesize that the treatment will be effective in improving clinical~     signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian~     Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to~     patients in Singapore.~   "
143937|NCT01683305|"~     This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of~     cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically~     detectable tumors, and those who have detectable tumors, 2) identify all the detectable~     markers and 3) establish that biomarkers detected in NAF could also be detected in the~     biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable~     tumors.~   "
143938|NCT01683292|"~     In this first study of inhaled apomorphine in Parkinson's disease patients, the primary~     objective is to find the minimum efficacious dose of apomorphine that is useful in rescuing~     patients during 'off' periods. Safety, tolerability and pharmacokinetics of inhaled~     apomorphine will be assessed during the study.~   "
143939|NCT01683279|"~     Patients with relapsed leukemia often develop resistance to chemotherapy. For this reason, we~     are attempting to use a patient's own T cells, which can be genetically modified to expresses~     a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill the~     leukemic cells though the recognition of CD19, a protein expressed on the surface of the~     majority of pediatric ALL. This is a phase I study designed to determine the maximum~     tolerated dose of the CAR+ T cells and define the toxicity of the treatment. As a secondary~     aim, we will be looking at the efficacy of the T cells on eradicating the patient's leukemic~     cells.~   "
143953|NCT01683097|"~     This study aims at assessing factors that affect patient choices for end of life care. 300~     patients would be assigned either to a control arm (questionnaire alone) or intervention arm~     (standardized explanation+ questionnaire). Our intervention is a standardized explanation~     which explains what code status, advance directive and end of life care mean. Based on~     patient responses, factors that affect choices of code status would be analyzed. We will also~     evaluate if a standardized explanation improves patient understanding of end of life issues.~     This would be determined by generating a composite score of correct responses to a subset of~     objective questions in the questionnaire~   "
143940|NCT01683266|"~     Primary Objective:~        -  To compare the efficacy of a new formulation of insulin glargine and Lantus (overall,~          regardless the injection time) in terms of change of HbA1c from baseline to endpoint~          (scheduled Month 6) in participants with type 1 diabetes mellitus~      Secondary Objective:~        -  To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms~          of:~        -  Change of HbA1c from baseline to endpoint (scheduled Month 6)~        -  Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma~          glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma~          glucose (8-point profiles), glucose variability, treatment satisfaction and health~          related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)~        -  Reaching target HbA1c values and controlled plasma glucose (all and reaching target~          without hypoglycemia)~        -  Frequency of occurrence and diurnal distribution of hypoglycemia by category of~          hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)~        -  Safety and tolerability of HOE901-U300 including development of anti-insulin antibody~          (AIAs) during the 12-month study period~   "
143941|NCT01683253|"~     The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved~     and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist~     to levodopa/carbidopa in patients with Parkinson's disease who have been treated with~     dopaminergic medications.~   "
143942|NCT01683240|"~     Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic~     device, which is designed to give a better flexibility to the cholangioscopy tip in order to~     enable optimal diagnostic and therapeutic precondition. Other than the conventional~     mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at~     the side of a specially developed duodenoscope (mother part) which is prepositioned distally~     to the control unit, near to the patient's mouth. Better manoeuverability of the device tip~     will lead to both a better accuracy in taking biopsies as well as a better flexibility in~     lithotripsy manoeuvres. This study is designed to test the efficiency of the device in~     relation to this assumption.~   "
143943|NCT01683227|"~     Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive,~     integrated public health approach to identify and deliver a spectrum of early detection and~     intervention services for substance use in general medical care settings. These settings,~     such as emergency department visits, offer a potential teachable moment because patients~     may have perceptions of vulnerability about their health, and therefore be particularly~     receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT~     is effective in reducing alcohol use at varying levels of severity in a myriad of health care~     settings including primary care, emergency departments, and trauma centers. Although the~     SBIRT approach has shown promise for alcohol, relatively little is known about its~     effectiveness for adult illicit drug use specifically.~      This will be among the first studies to rigorously test the SBIRT approach for drug use. It~     will evaluate the effectiveness of SBIRT for drug use and related factors for 700~     multi-ethnic ED patients using a two-group randomized repeated-measures design in which~     biologically-validated drug use abstinence and related outcomes of an intervention group are~     compared to those of an attention-placebo control group. Over a 14-month period,~     bilingual/bicultural Health Educators recruited participants who reported past 30-day illicit~     drug use in excess of risky alcohol use from the waiting areas of two large hospital's ED and~     trauma units. Following consent procedures and standardized baseline assessments, Health~     Educators randomly assigned participants to one of the two conditions. The intervention group~     received Life Shift, an SBIRT drug use intervention matched to the participant's drug use~     risk level. The control group received the same type and quantity of intervention in an~     unrelated area—Driving and Traffic Safety (Shift Gears program), also matched to their~     driving/traffic risk level. A 6-month face-to-face follow-up visit by trained measurement~     technicians blind to the participant's assigned condition collected standardized self-report~     past 30-day drug use measures (ASI-Lite)and hair samples for validating self-reported~     abstinence. Additional outcome variables are changes in the frequency of drug use, functional~     status measures (i.e., medical problems, psychiatric problems, and alcohol use), and health~     care utilization.~   "
143944|NCT01683214|"~     The investigators are conducting this study to test the usefulness of a new type of analysis~     of electroencephalographic (EEG) recordings called brain network activation or BNA. BNA~     allows to identify patterns of activation in brain networks and to track their changes over~     time. The investigators want to examine the possible role of brain network activation (BNA)~     in the diagnosis of mood disorders and predicting improvement over time. The procedure~     conducted with patients diagnosed with a mood disorder will be compared to people who do not~     have a mood disorder.~   "
143945|NCT01683201|"~     The aim of this research project is to evaluate the efficacy of a specific functional~     exercise programme to improve pain, stiffness and physical function in patients post total~     hip replacement from week 12 to week 18 post surgery.~   "
143946|NCT01683188|"~     This is a research study to evaluate treatment of metastatic melanoma patients with a~     combination of drugs. The combination being studied is vemurafenib (also known as Zelboraf®)~     and High Dose Interleukin-2 (abbreviated as HD IL-2 and known as Proleukin®). The combination~     of vemurafenib and HD IL-2 immunotherapy may enhance the response.~   "
143947|NCT01683175|"~     This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation~     IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR)~     19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.~   "
143948|NCT01683162|"~     Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in~     preterm infants, a showed efficacy and a good clinical and biological safety profile. The~     objective of this study was to assess the effects of a new olive-oil based lipid emulsion~     compared with the traditional lipid emulsions.~   "
143949|NCT01683149|"~     H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator,~     but will not be recruiting locally.~      The purpose of this research study is to establish a dose of the combination of drugs,~     Topotecan and Sorafenib in children. This will be called the maximum tolerated dose. The~     chemotherapy in this study is a combination of Topotecan and Sorafenib. The investigators are~     trying to find the highest dose of Topotecan and Sorafenib that can be given safely to~     children with Refractory or Recurrent Pediatric Solid Malignancies. The investigators will do~     this by testing different doses of these drugs in different groups of children. The~     investigators will also study how the body processes these drugs.~   "
143950|NCT01683136|"~     This is an open study.approximately 20 patients diagnosed with Borderline Personality~     Disorder (in case patient is under drug treatment, treatment should be stable within the~     prior 4 weeks before study entry).Starting from the third day, subjects would undergo rTMS~     (repetitive Transcranial Magnetic Stimulation) for five days a week, for four weeks, and will~     be clinically evaluated in order to monitor for improvement.~      The investigators anticipate a significant reduction in symptoms severity at the end of the~     treatment compared to study entry.~   "
143955|NCT01683071|"~     The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome~     bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect~     achieved following single dose injection femoral nerve block with liposome bupivacaine, and~     (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be~     tested in Part 2.~      Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the~     analgesic effect of single injection femoral nerve block of a single dose level of liposome~     bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).~   "
143956|NCT01683058|"~     The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program~     and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the~     treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive~     treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297)~     will allow the subjects who complete Trial 291 to enter this open label trial at the~     investigator's discretion, where additional safety and tolerability data will be collected.~   "
143957|NCT01683045|"~     The purpose of this study is to demonstrate that the Estech COBRA Surgical System is an~     effective treatment for patients with irregular heart beats who are undergoing heart surgery.~   "
143958|NCT01683032|"~     Creative cognition plays an important role in art, invention and innovation, as well as in~     everyday life and thus has a significant effect on society as a whole. Research with healthy,~     normal participants and those with attention deficit hyperactivity disorder indicates a~     possible inverse relationship between attentional function and creativity. This evidence~     raises the possibility that Methylphenidate (MPH; Ritalin) could decrease creativity in~     people using it for cognitive enhancement. However, this question has not been addressed by~     previous studies. Hence, the present study aims to examine the effect of MPH on creativity in~     healthy young adults.~   "
143959|NCT01683019|"~     This feasibility study investigates effects of EEG-based low frequency, low emission magnetic~     cortical stimulation in comparison to a sham treatment in subjects with moderate to severe~     depressive disorder.~   "
143960|NCT01683006|"~     The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy~     rate during hypothermia after cardiac arrest.~   "
143961|NCT01682993|"~     Topography guided laser treatment enables the surgeon to correct higher order aberrations in~     corneas with irregular astigmatism. Several case reports and small uncontrolled trials have~     been published on the combination of this treatment with corneal cross linking (CCL) in~     patients with ectatic corneal diseases.~      This randomized study will evaluate the safety and efficacy of a combined treatment of~     corneal cross linking with a partial topography guided excimer laser treatment in eyes with~     progressive ectatic corneal diseases.~   "
143962|NCT01682980|"~     The overall contribution of this study is to increase the knowledge of the efficacy of~     strength and aerobic exercise on knee related quality of life, knee pain,physical function~     and the morphology of the cartilage in patients with knee osteoarthritis (OA). Knee OA is one~     of the most important diseases within musculoskeletal conditions affecting a considerable~     number of people worldwide. This randomized controlled trial will involve one intervention~     group delivered strength exercises compared to another intervention group delivered aerobic~     exercise (ergometer cycling). The two intervention groups will be compared to a control group~     undergoing usual care. Cost-effectiveness analysis will be performed comparing the three~     groups. The study is funded from The Research Council of Norway.~   "
143963|NCT01682967|"~     Headache following accidental dural punction as during epidural analgesia can be severe and~     sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural~     puncture. Although spontaneous resolution of headaches is common in most patients within 7~     days, in 20% can they be persistent and in some very disabling. The exact reason for the~     characteristic headache is unknown, but it is believed to be the result of leakage of~     cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the more~     severe and persistent the headache. This is why larger needles (lower gauge) are known to~     have a higher incidence of PDPH. However, the type of needle also seems to play an important~     role in the likelihood of PDPH.~      Headache following accidental PDPH is very typical as it increases significantly when sitting~     or standing and often disappears completely on lying down. It is typically located in the~     back of the head, accentuated by light and often decreases with intake of large quantity of~     fluids. In many cases, it is self-limiting and most often decreases with time and bed rest.~      Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage,~     as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing~     that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test the~     hypothesis that measurement of hearing loss may be a diagnostic method for confirmation of~     clinical symptoms and signs of accidental PDPH.~   "
143964|NCT01682954|"~     The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for~     diabetes prevention among employees with prediabetes.~   "
143965|NCT01682941|"~     RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer.~     Isoflavones are compounds found in soy food that may prevent cancer.~      PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in treating~     patients with recurrent prostate cancer or rising prostate-specific antigen~   "
143966|NCT01682928|"~     OBJECTIVE: To assess the efficacy of subtotal immersion therapy as an option to improve~     maternal intravascular volume thereby improving both maternal and fetal hemodynamic status~     with reversal of oligohydramnios. This will be measured utilizing the Amniotic Fluid Volume~     (AFV) as the primary outcome. Secondary outcomes will be measured using Fetal Doppler~     Studies, Maternal vital signs (Blood Pressure, Pulse Pressure, Weight, Pulse) and~     input/output.~      HYPOTHESIS: Oligohydramnios, secondary to depleted maternal intravascular volume, can be~     reversed by improving feto- and uteroplacental perfusion with subtotal immersion therapy.~   "
143997|NCT01682525|"~     To provide a novel fertility preservation option for patients facing a fertility threatening~     cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation~     program. To determine if ovarian tissue cryopreservation provides women with a useful,~     successful option for fertility preservation~      The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an~     alternative option for fertility preservation.~   "
143967|NCT01682915|"~     Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, clinically and~     genetically heterogeneous neuropsychiatric disorder with lifelong executive dysfunctions. The~     ultimate goal of this 3-year case-control imaging genomic study with unaffected siblings and~     typically developing (TD) children as controls is to identify useful imaging endophenotype~     for ADHD by investigating the structural connectivity, as assessed by diffusion spectrum~     imaging (DSI), and functional connectivity, as assessed by resting-state fMRI (rsfMRI) of~     brain regions related to cognitive/executive controls with regards to the ADHD status and the~     presence of dopamine transporter gene variants (DAT1).~      Specific Aims:~        1. to validate the executive functions, visuospatial memory, and structural and functional~          connectivity in frontostriatal, and frontoparietal circuitries as effective~          neurocognitive endophenotypes;~        2. to correlate the data from structural and functional connectivity, neuropsychology, and~          ADHD core symptoms stratifying by the presence of ADHD, proband-unaffected sibling~          dyads, and the presence of DAT1 variant; and~        3. To investigate reported candidate genes, in addition to DAT1 variant, related to~          dopamine and noradrenergic neurotransmitter systems in the association with~          neurocognitive endophenotypes such as DRD1, DRD2, DRD4, DRD5, DBH, MAO-A, ADRA2A,~          ADRA2C, NET, and COMT.~   "
143968|NCT01682902|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects~     with type 1 diabetes.~   "
143969|NCT01682889|"~     The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on~     hemodynamic and on parameters of microcirculation in patients with peripheral arterial~     occlusive disease (PAOD).~   "
143970|NCT01682876|"~     This study was designed to conduct a comparative trial to further evaluate the safety,~     immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine,~     given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2~     through 10 years of age.~   "
143971|NCT01682863|"~     This study is to assess the safety and tolerability of two different doses of QVA149 and~     QAB149 in patients with moderate to severe airflow limitation.~   "
143972|NCT01682850|"~     This study seeks to study the effectiveness of a short mindfulness based pulmonary~     rehabilitation program prior to a surgical resection in patients with lung cancer and severe~     Chronic Obstructive Lung Disease (COPD).~   "
143973|NCT01682837|"~     Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood~     pressure among patients with pre- or Stage I hypertension on their customary diet.~   "
143974|NCT01682824|"~     The goal of this research study is to learn more about eating practices of survivors of~     childhood Central Nervous System (CNS) tumors (including brain and spinal cord tumors).~      Recent research shows that childhood cancer survivors are experiencing many health issues~     months or even years after active cancer treatment (for example, irregular blood sugar~     levels, overweight/obesity, and heart disease). To address this growing concern, researchers~     at MD Anderson Children's Cancer Hospital and Texas Children's Cancer Center have joined~     forces to learn more about how to design a program that would promote healthy lifestyles~     among survivors of childhood cancer.~   "
143975|NCT01682811|"~     GENERAL OBJECTIVE The general objective is to assess the safety and efficacy of photodynamic~     therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin.~      SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and~     efficacy of PDT using 5-aminolevulinic acid (ALA) and 630 nm light in the treatment of benign~     dermal neurofibromas.~      Specifically, the primary goal of the current study is to determine the maximum tolerable~     light doses that can be administered to subjects undergoing topical photoillumination~     photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical~     Solution.~   "
143976|NCT01682798|"~     The purpose of this study is to determine whether Yili Chang Qing Pro-ABB yoghurt is~     effective in improving mild constipation and the intestinal micro-ecology environment &~     alimentation.~   "
143977|NCT01682785|"~     Aim 1 is to study prevalence and 1 year incidence of metabolic syndrome in major depressive~     disorder and factors correlation.~      Aim 2 is to study prevalence and 1 year incidence of thyroid dysfunction in major depressive~     disorder and factors correlation.~   "
143978|NCT01682772|"~     This is an open-label, single arm, two part adaptive design phase II trial of Olaparib in~     patients with advanced castration resistant prostate cancer.~      The trial aims to evaluate the the anti-tumour activity of Olaparib in metastatic castration~     resistant prostate cancer, identify molecular signatures of tumour cells in responding and~     non-responding patients, and to identify predictive biomarkers of Olaparib response.~   "
143979|NCT01682759|"~     This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the~     sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic~     control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks,~     the mean change from baseline in hemoglobin A1C (A1C) in participants treated with~     omarigliptin is non-inferior compared with that in participants treated with glimepiride.~   "
143980|NCT01682746|"~     The goal of this proposal is to evaluate a new Photodynamic Therapy (PDT) modification which~     could revolutionize the treatment of brain tumors in children and adults. There are currently~     few cases published involving the use of PDT in infratentorial (in the posterior fossa) brain~     tumors in general and specifically those occurring in children. The investigators propose to~     test a technique, for the first time in the U.S., that demonstrated in Australian adult~     glioblastoma patients dramatic long-term, survival rates of 57% (anaplastic astrocytoma) and~     37% (glioblastoma multiforme). These results are unprecedented in any other treatment~     protocol.~      Photodynamic therapy (PDT) is a paradigm shift in the treatment of tumors from the~     traditional resection and systemic chemotherapy methods. The principle behind photodynamic~     therapy is light-mediated activation of a photosensitizer that is selectively accumulated in~     the target tissue, causing tumor cell destruction through singlet oxygen production.~     Therefore, the photosensitizer is considered to be the first critical element in PDT~     procedures, and the activation procedure is the second step. The methodology used in this~     proposal utilizes more intensive laser light and larger Photofrin photosensitizer doses than~     prior PDT protocols in the U.S. for brain tumor patients. The PDT will consist of~     photoillumination at 630 nm beginning at the center of the tumor resection cavity, and~     delivering a total energy of 240 J cm−2. The investigators feel that the light should~     penetrate far enough into the tissue to reach migrating tumor cells, and destroy these cells~     without harming the healthy cells in which they are dispersed.~      The investigators will be testing the hypothesis that pediatric subjects with~     progressive/recurrent malignant brain tumors undergoing PDT with increased doses of~     Photofrin® and light energy than were used in our previous clinical study will show better~     progression free survival (PFS) and overall survival (OS) outcomes. PDT will also be~     effective against infratentorial tumors. The specific aims include determining the maximum~     tolerable dose (MTD) of Photofrin in children and looking for preliminary effectiveness~     trends.~   "
143981|NCT01682733|"~     The proposed study is a prospective, pilot study to assess the feasibility of a novel~     endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for~     the primary treatment of obesity. The investigators aim to recruit ten subjects with a body~     mass index between 30-40 for this study. Vertical sutures will be performed using the~     endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum~     toxin(approximately 30 units) will be injected around the sutures insertion sites in half of~     the subjects randomly to slow down muscular grinding of the stomach to see if it improves~     durability of the procedure.~   "
143982|NCT01682720|"~     This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with~     ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.~   "
143983|NCT01682707|"~     Opioids provide greater patient comfort during intubation, but are not able to abolish~     completely the release adrenergic hormones during the laryngoscopy, which may cause~     undesirable hemodynamic changes.~      In this study the investigators selected two techniques commonly used for intubation,~     laryngoscopy and track light, so the investigators can verify which intubation techniques~     provides less hemodynamic changes in coronary patients under standard anesthesia induction.~   "
143984|NCT01682694|"~     A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected~     by a reduction in serum C-reactive protein.~   "
143985|NCT01682681|"~     The purpose of this study is to evaluate the long-term retention rate of topiramate in~     participants with epilepsy (seizure disorder).~   "
143986|NCT01682668|"~     This program aims to understand the role of the subthalamic nucleus in the control of the~     movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction~     contributes to akinesia and how the STN stimulation improves motor signs in PD patients .~   "
143987|NCT01682655|"~     In the past decades, obesity in children is much more prevalent in the world. Given the~     increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.~      Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat~     content in adults.~      The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP)~     influence fatty liver in obese children and adolescent.~   "
143988|NCT01682642|"~     In this study of endometriosis patients we compare a common treatment of surgical therapy and~     medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In~     both cases they immediately start In Vitro Fertilization (IVF) treatment.~   "
143989|NCT01682629|"~     The investigative team's purpose for conducting this research is to improve effective and~     efficient translation and implementation of evidence based advanced life support practice to~     providers of care for children. This specific project aims to accomplish 2 major goals. The~     investigators aim to evaluate the utility of a debriefing script specifically designed to~     facilitate debriefing when used by novice Pediatric Advanced Life Support instructors during~     low and high realism simulation-based learning. Secondly, the investigators hope to evaluate~     the effectiveness of high realism simulation vs. low realism simulation in achieving~     PALS-based educational outcomes, such as knowledge and skill acquisition.~      The investigators hypothesize that SCRIPTED debriefing by novice instructors following low~     and high fidelity simulation-based learning will :~        1. Improve the cognitive performance and knowledge of multidisciplinary team members as~          assessed by a cognitive performance tool and multiple choice testing compared with more~          traditional, NON-SCRIPTED debriefing;~        2. Improve the behavioural, teamwork and communication skills of multidisciplinary team~          members as assessed by a validated assessment tool compared with more traditional,~          NON-SCRIPTED debriefing;~      The investigators hypothesize that HIGH REALISM simulation-based learning will:~        1. Improve the cognitive performance and knowledge of multidisciplinary team members as~          assessed by a cognitive performance tool and multiple choice testing compared with more~          traditional, LOW REALISM simulation;~        2. Improve the behavioural, teamwork and communication skills of multidisciplinary team~          members as assessed by a validated assessment tool compared with more traditional, LOW~          REALISM simulation;~   "
143990|NCT01682616|"~     This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of~     ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic~     Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess~     the safety profile, to determine the maximum tolerated dose and establish the Recommended~     Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose~     escalation portion of the study will include approximately 30 subjects. Once the recommended~     phase two dose and schedule have been determined, up to 20 additional subjects will be~     enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi,~     or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs,~     as defined by iwCLL NCI/WG criteria for tumor response, subjects may re-initiate ABT-199.~   "
143991|NCT01682603|"~     To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on~     neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of~     expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of~     patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI)~     patients.~   "
143992|NCT01682590|"~     The purpose of this multicentric, randomized controlled trial is to assess whether the timing~     of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90~     days in patients with severe acute kidney injury at the failure stage (according to RIFLE~     criteria) during the initial phase of septic shock.~   "
143993|NCT01682577|"~     The objective of this study was to find out whether the bioavailability of PT Dexa Medica's~     formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the~     innovator's product (Prexum® 4 mg, Servier).~   "
143994|NCT01682564|"~     To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on~     blood pressure in patients with hypertension diagnosed congestive heart failure~   "
143995|NCT01682551|"~     This trial is aimed to evaluate the effects of Wu Zhu Yu Tang on the prevention of Acute~     Mountain Sickness(AMS).~   "
143996|NCT01682538|"~     The study is primarily being performed in order to demonstrate bioequivalence between the~     Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also~     contain a comparison of the bioavailability of the suspension given with food and on an empty~     stomach.~   "
143998|NCT01682512|"~     The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI~     695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and~     rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on~     the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to~     Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.~   "
143999|NCT01682499|"~     This is a pilot study evaluating the feasibility of intravenous calcium and magnesium (Ca/Mg)~     infusion for prevention of taxane induced neuropathy in patients with early stage breast~     cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for 4 cycles~     or every week for 12 weeks.~   "
144000|NCT01682486|"~     The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s~     tolerability, safety and performance and compare it to a standard un-coated Endotracheal~     tube.~   "
144001|NCT01682473|"~     To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of~     ZSTK474 in patients with advanced solid malignancies.~   "
144002|NCT01682460|"~     Research indicates that many people who are being treated for glaucoma have dry eyes. The~     purpose of this study is to test the use of artificial tears to alleviate dryness signs and~     symptoms in people who are using medication to treat glaucoma. The study hypothesis is that~     the use of artificial tears will result in an improvement in clinical signs and symptoms~     associated with dry eyes.~   "
144003|NCT01682447|"~     The purpose of this project is to investigate whether a 12-week, fulltime pulmonary~     rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life~     in patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
144004|NCT01682434|"~     Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate~     myopia.~      Advances over the last decade have allowed LASIK to also correct higher order wavefront~     aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided~     treatment. However, it remains to be established whether there is a beneficial effect in~     higher degrees of myopia.~      The study aims to determine whether myopic subjects (-6 to -10 diopters) with~     higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided~     treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional~     treatment in the other.~   "
144005|NCT01682421|"~     After corneal transplantation, topical corticosteroids are used to reduce the risk of~     rejection.~      However, the optimal postoperative treatment regimen is unknown. In most cases, a topical~     steroid is administered for at least 6 months after surgery, but it remains to be determined~     whether potent steroids offer better protection than weak steroids. Also, the length of the~     treatment is debated.~      Since the use of steroids is not without potential serious ocular side effects, it is of~     considerable importance to investigate these problems.~      The study aims to examine the frequency of rejection episodes after posterior lamellar~     keratoplasty; specifically comparing a short course of potent steroids versus a long course~     of weak steroids.~   "
144006|NCT01682408|"~     Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is~     Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted~     State, and to Assess the Relative Bioavailability of Process Variants of Tablets~   "
144007|NCT01682395|"~     The purpose of this study is to obtain a better understanding of the best management of~     left-sided colonic emergencies.~   "
144008|NCT01682382|"~     Subjects with wet AMD, dry AMD, and age-matched controls will undergo routine occular~     measurements, will provide a blood and cheek cell sample, and will have macular pigment~     optical density (MPOD) measured to determine if there is an association between genetics,~     MPOD and the risk of progression to wet AMD.~   "
144009|NCT01682369|"~     Infants and young children do not respond as well as adults to the flu vaccines currently~     available in the UK. Fluad, is a different type of influenza vaccine that has been available~     in the European continent for the last decade, and contains an adjuvant known as MF59.~      This vaccine has been used extensively in adults over 65 years of age. It has been~     administered to over 4000 children in previous studies, which have shown that it produces an~     enhanced immune response in children compared with traditional vaccines, and that it is safe~     in this age group. It is, however, not yet licensed for use in children. The reason for this~     new study is to gain a better understanding of the how this vaccine is stimulating the immune~     system, by looking to see which parts of the genetic code are 'switched on' in response to~     immunisation, and to see how this differs from the response to currently used flu vaccines.~      To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive~     either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines~     currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find~     out whether it is possible to identify patterns of genetic response which can predict~     responses to immunisation. Being able to do so could potentially enable more rapid~     development of vaccines against influenza and other diseases in the future. We will also~     measure how well the immune system responds to the two vaccines and look at any side effects.~      The study is funded by Aditec is a collaborative research programme that aims to accelerate~     the development of novel and powerful immunisation technologies for the next generation of~     human vaccines.~   "
144025|NCT01682161|"~     The purpose of this study is to evaluate the change of medication satisfaction measured by~     Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are~     switched into paliperidone palmitate, either immediately or in a delayed mode.~   "
144026|NCT01682148|"~     The aim of this study is to compare Dysport treatment results after current clinical practice~     injection technique and high-concentration dilution to the neuromuscular junction targeted~     injection technique and low-concentration dilution in the elbow joint assessed by Modified~     Ashworth Scale 4 weeks post treatment. The hypothesis is that one high volume injection~     centrally located in the area/band of the NMJ zones will be as effective as the technique~     used today in current medical practice.~   "
144027|NCT01682135|"~     This trial is testing ramucirumab (LY3009806) administered to Chinese participants with~     advanced solid tumors that are resistant to standard therapy or for whom no standard therapy~     is available. The purpose of this study is to evaluate how safe ramucirumab is and whether it~     causes any side effects. The study will also measure how much ramucirumab gets into the blood~     stream and how long it takes the body to get rid of it.~   "
144010|NCT01682356|"~     The purpose of this study is to determine if nitrates in a food, in this case - beetroot~     juice (BRJ) - is efficacious in improving exercise tolerance and/or peak power in patients~     with heart failure. The investigators will also determine if BRJ improves blood pressure,~     exercise efficiency, vascular and muscle function, and whether blood levels of nitrates~     increase hourly for a total of 4 hours after BRJ ingestion. A secondary aim is to determine~     if BRJ-derived nitrates are still effective at 1, 2 and 4 weeks after starting treatment. A~     tertiary aim is to determine the variation in the 6 minute walk test. Subjects will answer a~     basic medical information sheet and undergo a 6-minute walk test. After at least a 48 hours~     rest, subjects will be asked to repeat the 6 minutes' walk. The investigators will (1)~     determine if BRJ (as compared to placebo) improves peak power output in heart failure~     patients and controls (at ~ 1½ to 2 hours after ingestion); (2) compare the changes in~     cardiac muscle (on average ~ 8-12 hours after) BRJ or placebo ingestion in patients who will~     be undergoing an left ventricle (LV) assist device placement for clinical purposes. (a~     cross-sectional study); (3) determine if BRJ decreases elevated pulmonary artery (PA)~     pressures or improves vascular and/or microvascular function (at ~ 1½ - 2 hours after~     ingestion) in patients who are already coming in for a PA catheter placement for clinical~     purposes; (4) compare the physiological changes after BRJ ingestion in non-heart failure~     control subjects with those of patients with heart failure. Endpoints measured at the same~     time points after ingestion. The investigators hypothesize (1) that patients with heart~     failure and controls will have improved exercise capacity and power at lower oxygen cost (and~     thereby greater efficiency) ~ 1½- 2 hours after ingesting beet juice (BRJ) than after~     ingesting placebo (beet juice without nitrates); (2) that patients with heart failure will~     have a greater physiologic response to BRJ than non-heart failure controls since the former~     have worse physiological function to start with; (3) that patients with high pulmonary artery~     pressures will have an improvement in the pressures after ingestion with BRJ; (4) that~     myocardial perfusion will be higher after BRJ ingestion than after placebo; (5) that cyclic~     guanosine monophosphate (cGMP) levels will be increased in left ventricle assist device~     (LVAD) samples after BRJ ingestion compared with placebo.~   "
144011|NCT01682343|"~     The purpose of this study is to investigate the appetite, insulin and incretin hormone~     responses to a high-calcium meal.~   "
144012|NCT01682330|"~     The purpose of the present study is to evaluate the long-term effects of 1 year of~     high-intensity fitness training and low-intensity whole-body vibration training on muscle~     strength and functionality. Therefore, muscle strength and functionality are measured after a~     6-yr interval in older adults (65+).~   "
144013|NCT01682317|"~     The purpose of this study is to address the gap in knowledge regarding the relationship~     between eating frequency and weight loss.~   "
144014|NCT01682304|"~     Preliminary data from the investigator's lab identified novel patterns of differential DNA~     methylation in genes regulating cardiovascular and metabolic function in blood from women~     during the first trimester of pregnancy who were destined to develop preeclampsia (PE) in the~     third trimester. Further, common patterns of differential DNA methylation were found in the~     common genes from placental tissue at time of birth in the same women after diagnosis with~     PE, suggesting that the epigenomic patterns that predict pregnancy-induced hypertension may~     also underlie the development of chronic hypertension years after.~      It is unknown whether aberrant DNA methylation in pregnancy-induced hypertension is the~     mechanism by which chronic hypertension develops in these women remote from pregnancy nor is~     it known if hypertension remote from PE is as responsive to therapeutic treatment of~     hypertension compared to women who develop hypertension without history of PE. The~     investigators plan to objectively test the central hypothesis and attain the objective of~     this project~   "
144015|NCT01682291|"~     The primary objective of this study is to compare the efficacy and tolerability of a~     life-style modifications protocol versus a protocol including life-style modifications along~     with a novel combination of dietary supplement in the management of subjects diagnosed as~     having pre-hypertension.~      The novel formulation includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna~     (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250~     mg/day)~   "
144016|NCT01682278|"~     The aim of this study is to evaluate if amalgam removal is associated with improved~     self-reported health, compared to no amalgam removal. The main target group consists of a~     group of patients with medically unexplained physical symptoms (MUPS), which they attribute~     to dental amalgam restorations. The patients should furthermore express the wish to have~     these amalgam fillings removed. The project is designed as a prospective cohort study,~     consisting of three groups recruited separately. The main target group will be compared with~     two comparison groups: one group of patients with MUPS recruited from general practice and~     one group of healthy study patients, recruited at dental practice. The primary research~     question is if amalgam removal is associated with improved self-reported health, compared to~     no amalgam removal, one year after completed amalgam removal.~   "
144017|NCT01682265|"~     The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency~     6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP)~     patients.~   "
144018|NCT01682252|"~     This study is being done as the doctor investigators would like to lessen the amount of blood~     transfusions given to patients. Patients who receive blood transfusions have a greater chance~     of developing complications after surgery. There is a device called the Cell Saver that~     allows the doctors to process blood that is lost during surgery and return it to the patient.~     This lessens the amount of transfused blood the patients receive. This device is not used for~     patients undergoing surgery for muscular skeletal tumors.The investigators are not sure~     whether tumor cells are present in the blood which is lost during the course of an operation~     like yours. The goal of this study is to see if we lessen the amount of blood transfusions~     given to patients who may have tumor or cancerous cells present in their blood. One way to do~     this is to test the blood that is circulating in your veins and also to test the blood which~     is lost during the course of your operation~   "
144019|NCT01682239|"~     Chronic right ventricular apical pacing has been associated with negative hemodynamic~     effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors.~     An important factor seems to be optimal lead positioning. Data regarding left ventricular~     function impaired by lead positioning is insufficient. The aim of the present study therefore~     is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing~     (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and~     clinical outcome.~   "
144020|NCT01682226|"~     The purpose of this study is to find out whether the addition of blood stem cells from a~     close family member, when added to umbilical cord blood will make the transplant safer.~   "
144021|NCT01682213|"~     In this study, the investigator's want to find out if dabrafenib can stop stage IIIC melanoma~     from coming back after surgery.~   "
144022|NCT01682200|"~     This study was conducted to determine the effects and side effects of ProOxy facial spray in~     the treatment of acne.~   "
144023|NCT01682187|"~     This is a study of oral LY2157299 as monotherapy and in combination with lomustine in~     participants with recurrent malignant glioma.~   "
144024|NCT01682174|"~     The purpose of this study is to assess whether added food ingredient(s) affect glycaemic~     responses to a liquid meal tolerance test (LMTT).~   "
144028|NCT01682122|"~     Wide Pulse Pressure is frequently present in the normal, full-term neonatal population. This~     study will evaluate the frequency and persistence of wide pulse pressure in the neonatal~     population. Using a prospective study design in the Regular newborn and Observation nurseries~     of SIUH, North site. Healthy newborns that are between 0-72 hrs of age will have their blood~     pressures measured using the oscillometric method. This data will offer insight into whether~     the presence of wide pulse pressure in otherwise healthy newborn infants warrants further~     cardiovascular evaluation~   "
144029|NCT01682109|"~     Palatability testing of a new paediatric formulation of valacyclovir in children 4-12 years~     of age and at least one of their parents. Children will be included, who received~     (val)acyclovir prophylaxis in the past, or will probably need it in the future i.e. children~     with primary immune deficiency or cancer.~   "
144030|NCT01682096|"~     The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is~     problematic when both, electrocardiogram and serum troponins are normal. Multidetector row~     computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of~     coronary artery disease.~      The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic~     strategy based on MDCT as compared to a strategy using stress echocardiography in the workup~     of patient with chest pain, normal electrocardiogram, normal troponins and suspected coronary~     artery disease. Additionally, the cost associated with both strategies will be compared.~      Methods. A total of 150 patients with acute chest pain coming to the emergency room with~     intermediate probability of significant coronary artery disease, normal ECG and troponins~     will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients~     showing coronary stenosis >50% at MDCT or abnormal stress echocardiography or inconclusive~     results will be admitted for further study. The primary endpoint of the study is the~     detection of an acute coronary syndrome, defined as typical or atypical angina with~     documented significant coronary artery disease (>50% stenosis) on invasive coronariography, a~     positive stress test or the occurrence of cardiac death, myocardial infarction or need for~     revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be~     evaluated by an experienced radiologist and cardiologist.~   "
144031|NCT01682083|"~     This is a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with~     trametinib versus two placebos in the adjuvant treatment of melanoma after surgical~     resection. Patients with completely resected, histologically confirmed, BRAF V600E/K~     mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc]~     cutaneous melanoma will be screened for eligibility. Subjects will be randomized to receive~     either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily~     [QD]) combination therapy or two placebos for 12 months.~   "
144032|NCT01682070|"~     The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum~     pratense based on reduction of upper airways reactivity after 5 months of treatment with~     different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety~     and tolerability will be assessed by the number of related Adverse Events of different~     dosages of SUBLIVAC FIX Phleum pratense compared to placebo.~   "
144033|NCT01682057|"~     The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic~     Coupler System (ACS) in patients with severe hypertension.~   "
144034|NCT01682044|"~     This phase II trial studies the side effects and how well giving pegfilgrastim together with~     rituximab works in treating patients with untreated, relapsed, or refractory follicular~     lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL).~     Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells~     found in bone marrow or peripheral blood and may help the immune system recover from the side~     effects of therapy. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer to grow and spread. Others find cancer cells~     and help kill them or tumor cancer-killing substances to them. Giving pegfilgrastim together~     with rituximab may kill more cancer cells~   "
144035|NCT01682031|"~     This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing~     mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin~     and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients~     receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more~     effective than a placebo in reducing mucositis~   "
144036|NCT01682018|"~     The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves~     (Zephyr) would reduce native lung overinflation in patients that underwent single lung~     transplantation due to emphysema, and improve their well being and pulmonary function tests.~   "
144037|NCT01682005|"~     This study aims to estimate the clinical and cost impact of RV vaccinations (both Rotateq®~     and Rotarix®) among children aged less than 5 years using insurance claims data from~     commercial plans and Medicaid low-income population. The impact of incomplete and complete RV~     vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8 months,~     8 months and onwards ) and calendar time of RV vaccination (e.g., 2006 onward).~   "
144038|NCT01681992|"~     The purpose of this study is to evaluate end of shelf-life potency in terms of the~     immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck~     & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).~   "
144039|NCT01681979|"~     Asthma is reported to affect between 3-14% of pregnancies making asthma medicines one of the~     most commonly used classes of medicines during pregnancy. Maternal asthma and in particular~     poorly controlled asthma has been found to be associated with a number of adverse perinatal~     outcomes including preterm delivery, low birth weight and pre-eclampsia. At present little is~     known about the safety in humans of many anti-asthma medicines when used during pregnancy. As~     a result all inhaled corticosteroids, with the exception of budesonide which is category B,~     have an FDA pregnancy category C, indicative of the fact there are no adequate and well~     controlled studies in humans.~      Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often~     in combination with the long-acting β-agonist salmeterol. Owing to small numbers of pregnancy~     exposures in the past, little is known about the safety of fluticasone propionate when used~     during pregnancy. A recent feasibility study, however, has shown that there are sufficient~     numbers of first trimester exposed pregnancies on the General Practice Research Database~     (GPRD) to allow the overall risk of major congenital malformations (MCMs) to be evaluated.~     This study also demonstrated that using data from the GPRD it is possible to determine an~     individual's exposure to anti-asthma medicines during pregnancy and to classify her treatment~     in terms of the British Thoracic Society treatment steps based on linked prescription and~     primary care data.~      The aims of this study are to 1) evaluate the safety profile of fluticasone propionate (FP)~     compared with exposure to all other inhaled corticosteroids with all major congenital~     malformations combined as the primary endpoint, whilst taking into account potential~     confounders and exposure to other anti-asthma medicine; and 2) test the null hypothesis that~     exposure to fluticasone propionate during the first trimester of pregnancy is not associated~     with increased overall risk of all major congenital malformations when compared to the risk~     in those exposed to other inhaled corticosteroids during the first trimester of pregnancy.~      The study will be a retrospective cohort study and will use data from the United Kingdom's~     General Practice Research Database (GPRD). The GPRD contains longitudinal medical records~     collected within UK primary care. All medical symptoms and diagnoses are recorded in the~     database, including those relating to pregnancy, in the form of Read Codes. In addition to~     coded data GPs have the option of recording un-coded comments ('free text'), such as more~     detailed descriptions of diagnoses or treatments along with information provided to them via~     hospital letters, referrals and discharge summaries.~      As the recording of stillbirths, neonatal deaths and pre-term births on the GPRD has not been~     verified, a verification exercise will be carried out. This will involve requesting and~     reviewing free text comments for 100 stillbirths, 100 neonatal deaths and 100 pre-term~     births. Free text comments will be requested if they are associated with a medical code~     related to pregnancy, delivery, post natal visits, death, post mortem, hospital letters and~     other forms of communication. If the free text is not found to be informative we will send~     questionnaires to the woman's GP.~      All outcomes will be identified and verified blinded to asthma treatment and severity levels.~   "
144040|NCT01681966|"~     LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended~     for local infiltration into surgical wounds. The purpose of this study is to determine the~     ease of usage and administration of LNP in the surgical setting, to follow the~     Pharmacokinetic (PK) profile of LNP over 72 hours and evaluate the duration of analgesia~     witnessed in the surgical setting.~   "
144041|NCT01681953|"~     The overall objective of this trial is to evaluate the efficacy and safety of repeated~     Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with~     alpha-Mannosidosis~   "
144042|NCT01681940|"~     The overall objective is to evaluate the long-term efficacy, safety and tolerability of~     repeated Lamazym i.v. treatment in patients 5-21 years of age with alpha-Mannosidosis~   "
144056|NCT01681758|"~     We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in~     patients after cardiac surgery who are mechanically ventilated leads to a significant~     decrease in the amount of fluid given to such patients in the first 24 hours after surgery~   "
144043|NCT01681927|"~     Idiopathic edema (IE) is an ill-defined syndrome of uncertain etiology that occurs virtually~     exclusively in women. It has also been referred to as cyclical edema, periodic edema, fluid~     retention syndrome and orthostatic edema.~      The present studies were designed to 1. Improve our ability to identify patients with~     idiopathic edema by extending the clinical criteria from an increase in weight of > 1.4 kg~     between 8 AM to 10 PM to the inclusion of nocturia, a very important component to the~     history. Additional aims are to: 2. Demonstrate orthostatic weight gain with or without edema~     in idiopathic edema and autonomic failure that will identify a greater number of patients~     suffering from variable degrees of weight gain and compare to controls or other conditions~     associated with edema. The study will focus mainly on subjects with polycystic ovaries and~     autonomic failure. 3. Provide a reasonable course of therapy that is presently not well~     defined. 4. Provide evidence that orthostatic edema or weight gain has two common etiologies,~     a. an increase in vascular membrane as in idiopathic edema and b. pooling of blood in the~     lower extremities in autonomic failure due to a lack of vascular tone.~   "
144044|NCT01681914|"~     Utilizing funding through the President´s Emergency Plan for AIDS Relief (PEPFAR) this~     project seeks to assess the effectiveness of a subset of the new Mozambican clinical~     guidelines for the diagnosis, initial management, and follow-up ( >1 follow-up visit to~     determine response to initial and/or second-line therapy) of common signs and symptoms in~     HIV-infected adult patients as used under field conditions by Mozambique-based clinicians in~     MOH health facilities in Zambézia province, Mozambique. The operational feasibility of the~     new guidelines will be described; they will be compared to the previous standard of care for~     the problem(s) of interest, and the clinical importance of differences between guidelines~     designed for Mozambican non-physician clinicians and new guidelines (also issued in late~     2009) for Mozambican physicians will be described. The subset of guidelines to be addressed~     in the current phase of this 2-year project includes algorithms for diagnosis and management~     of acute fever, persistent fever, and anemia.~   "
144045|NCT01681901|"~     This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older~     patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may~     help find breast cancer and find out how far the disease has spread~   "
144046|NCT01681888|"~     Movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent~     voluntary movement. Studies have suggested that using biofeedback to increase awareness of~     muscle activation can improve motor function in patients with motor deficits. The~     investigators hypothesize that the daily use of a surface electromyographic (SEMG)~     biofeedback device for one month will improve motor function in children and young adults~     with dystonia, hypertonia, and/or spasticity. The SEMG biofeedback device is worn over the~     muscle(s) the subject has difficulty in controlling and provides vibratory feedback about~     muscle activation. Groups of children and young adults (ages 3-21), with dystonia,~     hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory~     feedback device on their affected muscle(s) for 5 hours a day for one month. The device will~     vibrate and emit a blue light when the muscle is activated. At the start of the experiment,~     subjects will be tested on the Goal Attainment Scale (GAS), the Pediatric/Adolescent Outcomes~     Data Collections Instruments (PODCI), and the Barry Albright Dystonia Scale (BAD). For one~     month, subjects will practice goals without device. After a month, subject will be assessed~     again and be given device to practice goals for a month. After one month, the subjects will~     be tested on the outcome measures again and return device.~   "
144047|NCT01681875|"~     Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine~     content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction,~     other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure,~     intention to quit, compensatory smoking, other tobacco use, cigarette characteristics,~     cognitive function, cardiovascular function, and perceived risk. We will also consider~     differences between conditions in compliance with product use.~   "
144048|NCT01681862|"~     High blood pressure is the number one cause of death for Blacks in the United States. A major~     reason for the high rates of cardiovascular deaths is poor blood pressure control. Improving~     blood pressure control leads to large reductions in cardiovascular deaths in Blacks and can~     be achieved through interventions targeting self-management behaviors. Yet, despite the~     proven benefits of these interventions, there is little evidence of their role in~     community-based settings. In NYC, the Department of Health and Mental Hygiene (DOHMH) has~     developed Keep on Track, a volunteer-run, community program that aims to lower blood pressure~     of older adults through blood pressure monitoring sessions, brief counseling and health~     education. With support from DOHMH, lay health workers at faith-based organizations and~     senior centers take blood pressure readings for community members, record their readings on~     index cards and provide counseling to support lifestyle change and health care access.~     However, lay health workers administrating the program report difficulties managing the~     volume of tracking cards, and express interest in better tools to manage the information. To~     address this limitation, the primary aim of this study is to test the feasibility of~     implementing a Personal Health Record (PHR) system in two predominately Black churches in NYC~     to help lay health workers track changes in blood pressure and health behaviors of the~     participating congregants. The secondary aims are to evaluate the effect of the PHR system on~     changes in blood pressure, physical activity, weight loss, fruit and vegetable intake, and~     number of visits to a primary care physician from baseline to 9 months. The investigators~     hypothesize that congregants who enroll in the PHR system will have a greater reduction in~     BP; an increased intake of fruits and vegetables and levels of physical activity; weight~     loss; and report a great number of visits to their doctor at 9 months.~   "
144049|NCT01681849|"~     The purpose of this study was to assess the effects of the medication paroxetine on symptoms~     of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related~     to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD~     symptoms accompanied by changes in brain functional response to reminders of childhood~     trauma.~   "
144050|NCT01681836|"~     This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will~     result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited~     toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in~     vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and~     nitrite capsules for cardiovascular disease.~   "
144051|NCT01681823|"~     To determine if the oral administration of PectaSol-C Modified Citrus Pectin (MCP) is~     effective at improving Prostate Specific Antigen (PSA) kinetics in men with biochemical~     relapsed prostate cancer and serial increases in PSA levels. Also, documentation of any side~     effects or benefits within parameter of the study is included.~   "
144057|NCT01681745|"~     This study is designed to characterize the biological response of the epidermis, dermis and~     subcutaneous tissue to treatment with the myoscience Cryo-Touch III system.~   "
144060|NCT01681706|"~     The purpose of this non-interventional study is to implement a survey initiative to assess~     HIV prevalence for one or more diseases and/or conditions within a specific segment of the~     population not yet diagnosed with HIV, who presents for care with the specific~     disease/condition.~      The list of diseases below is not indicative of the most important indicator diseases for HIV~     but rather a list of diseases suggested for surveillance.~      This study will enrol patients presenting with the following diseases/conditions:~        1. Presenting for care of malignant lymphoma, irrespective of type~        2. Presenting for care of cervical or anal dysplasia or cancer, (Cervical CIN II and above)~        3. Presenting for care of Hepatitis B or C virus infection (acute or chronic - and~          irrespective of time of diagnosis relative to time of survey),~        4. Presenting with ongoing mononucleosis-like illness~        5. Presenting with unexplained leukocytopenia or thrombocytopenia lasting at least 4 weeks~        6. Presenting with seborrheic dermatitis / exanthema~        7. Presenting with pneumonia, admitted to hospital for at least 24h~        8. Presenting with unexplained lymphadenopathy~        9. Presenting with peripheral neuropathy of unknown cause (diagnosed by neurologist)~       10. Presenting with primary lung cancer~       11. Presenting with severe or recalcitrant psoriasis (newly diagnosed)~   "
144061|NCT01681693|"~     The current study is part of a large multi-investigator grant to look at the pharmacogenetics~     of a number of membrane transporters. The investigators will study individuals with~     particular genotypes of the human organic cation transporter, (hOCT3), and the multidrug and~     toxin extrusion transporter, MATE1 to test the hypothesis that genetic variation in hOCT3 and~     hMATE1 are associated with variation in the pharmacokinetics and/or pharmacodynamics of the~     antidiabetic agent, metformin.~   "
144062|NCT01681680|"~     The current study is part of a large multi-investigator grant to look at the pharmacogenetics~     of a number of membrane transporters. The investigators will study individuals with~     particular genotypes of the human organic cation transporter, (hOCT2), and the multidrug and~     toxin extrusion transporters, MATE1, MATE2-K to test the hypothesis that genetic variation in~     hOCT2, hMATEE1 and hMATE2-K are associated with variation in the pharmacokinetics and/or~     pharmacodynamics of the antidiabetic agent, metformin.~   "
144063|NCT01681667|"~     Ibuprofen (also known as Advil or Motrin) is a medication that is known to reduce pain. It is~     also known that ibuprofen levels in the blood rise higher and faster if the medication is~     taken in liquid suspension. This study will attempt to determine if ibuprofen suspended in a~     liquid works to relieve sore throat pain faster than pills of ibuprofen. It will also~     determine whether patients with sore throat prefer to take pill or liquid form of the~     medication.~   "
144064|NCT01681654|"~     Research on physical activity and nutrition interventions aimed at positively impacting~     symptom management, treatment-related recovery and quality of life has largely excluded head~     and neck cancer populations. This translates into a lack of clinical programming available~     for these patient populations. Head and neck cancer patients deal with severe weight loss,~     with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times,~     decreased quality of life (QoL), and impaired physical functioning. To date, interventions to~     address body composition issues have focused solely on diet, despite findings that~     nutritional therapy alone is insufficient to mitigate changes. A combined physical activity~     and nutrition intervention, that also incorporates important educational components known to~     positively impact behaviour change, is warranted for this population. Pilot work suggests~     that there is large patient demand and clinic support from the health care professionals for~     a comprehensive program. Therefore, the purpose of the present study is to examine the impact~     of timing of a 12-week PA and nutrition intervention (either during or following treatment)~     for HN cancer patients on body composition, recovery, serum inflammatory markers and quality~     of life. In addition, the investigators will examine the impact of a 12-week maintenance~     program, delivered immediately following the intervention, on adherence, patient-reported~     outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and~     side-effects), as well as return to work. The investigators hypothesize that (1) patients who~     are randomized to the intervention at treatment start will experience improved symptom~     management and decreased lean body composition changes, directly improving recovery and QoL;~     (2) patients who receive a maintenance support program will have better long-term adherence~     and therefore superior treatment-related symptom management, physical and psychosocial~     functioning; and (3) return to work indices will improve and healthcare utilization costs~     will be lower in the participants who receive the immediate intervention (vs. delayed) as~     well as in those who receive the maintenance program (vs. no maintenance). This research will~     facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path~     for a physical activity and wellness education model that can be implemented in other cancer~     centers.~   "
144065|NCT01681641|"~     Parkinson's disease is a chronic progressive neurological disorder. Symptoms are tremor,~     slowness in movement, rigidity and postural instability. As the disease progresses and~     treatment with L-dopa is no longer sufficient, some patients may be treated with deep brain~     stimulation.~      When treated with deep brain stimulation, electrodes are inserted in the affected area of the~     brain and through stimulation, motor symptoms of Parkinson's disease are significantly~     reduced.~      During the first year of DBS treatment patients and spouses may experience changes in~     everyday life and illness trajectory posing new opportunities as well as new challenges.~      The purpose of the study is to develop an individualised and targeted nursing program to~     support patients and relatives manage changes and challenges in life the first three months~     after Deep Brain Stimulation. The intervention is expected to generate important knowledge~     that will serve as a foundation for the further development of a future nursing program.~   "
144066|NCT01681628|"~     Thought Field Therapy (TFT) is a simple technique that involves tapping on points of the body~     corresponding to the meridians used in acupuncture. By using specific sequences, TFT can be~     used to treat a variety of psychological problems. Patients can be taught to treat~     themselves, and lay people can be trained to treat others in their community, as has been~     shown for narrative exposure therapy.~      Thought Field Therapy has been used to treat whole communities who have suffered~     psychological trauma following natural disasters and violent conflicts. In these~     circumstances, TFT can be used as a stand-alone therapy, or as an adjunct to other~     psychological therapies, by removing the pain of re-living the traumatic events.~      Studies in Rwanda have shown that individuals within a community can be treated with brief~     TFT sessions. Both short-term and longer-term improvements in scores of Post-Traumatic Stress~     Disorder (PTSD) measurement scales have been demonstrated.~      The Kasese District in Uganda has suffered from factional conflicts and the consequences of~     the ongoing struggles in neighbouring countries for many years. Although the government has~     controlled the situation and secured the borders, many are still haunted by the psychological~     consequences.~      The purpose of the study is to validate the model of addressing widespread psychological~     trauma following conflict by training community leaders to help others in their community~     using TFT.~      Thirty-six community leaders will be given a two-day training in algorithm level~     trauma-relief TFT. They will then treat 128 volunteers for their traumas, using TFT, who will~     be assessed before and one week after treatment by the post-traumatic stress disorder~     check-list questionnaire for civilians (PCL-C). As a control, a further 128 volunteers will~     join a wait-list group, who will be assessed at the same time, but treated later.~      PCL-C scores before and after treatment will be compared with the wait-list group scores~     before and after waiting, but before their treatment.~      A follow-up assessment of the participants will be undertaken 1 to 2 years later.~   "
144067|NCT01681615|"~     The investigators want to find new challenge test for Acetylsalicylic hypersensitivity /~     Aspirin hypersensitivity. The investigators suggest that this new test will be as efficient~     as the already established protocols in terms of sensitivity and specificity.~   "
144068|NCT01681602|"~     Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only~     temporarily slow down progression.~      Exercise has the potential to improve cognition, psychological symptoms, physical performance~     and quality of life, but evidence is scarce. Previous trials are short, often underpowered~     and involving home based light exercise programs. Most have included nursing homes residents~     with severe or undefined dementia. The aim of the ADEX trial is to establish whether exercise~     is effective in improving cognition, physical performance and quality of life as well as~     reducing the prevalence of psychological symptoms among AD patients.~      Methods: The ADEX Trial is a multicentre, single-blind, randomized clinical trial. Based on~     power calculations the investigators plan to recruit 192 home-dwelling patients aged 50-90~     years with mild to moderate AD. The participants will be randomly allocated into two groups:~     An intervention group attending 16 weeks of continuously supervised moderate aerobic exercise~     1 hour three times a week and a control group only receiving usual care. The hypothesis is~     that aerobic exercise will improve physical function, the cognitive and daily functioning and~     quality of life in people with mild to moderate AS.~      Blood sampling will be performed in all subjects to examine effects on biomarkers. A subgroup~     of the patients will also undergo MRI, PiB-PET and lumbar puncture to investigate structural~     changes and β-amyloid accumulation.~      Further, a health-economic analysis will be performed.~      Recruitment was started in January 2012. Last study visits are planned to be performed in~     January 2014 and results will be available in 2014. This RCT will contribute to evidence~     regarding the potential effects of a systematic program of physical exercise for patients~     with Alzheimer's disease.~   "
144069|NCT01681589|"~     The purpose of this pilot study is to investigate the relationship between attention and~     emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the~     cognitive mechanisms of emotional processing in patients with TBI, and explore novel~     treatment strategies to improve emotional regulation using with transcranial direct current~     stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.~   "
144070|NCT01681576|"~     This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and~     blood pressure in salt-sensitive Asian hypertensive patients.~   "
144071|NCT01681563|"~     This is a phase II multicenter, non-comparative, open label study in older previously~     untreated Chronic Lymphocytic Leukaemia patients, requiring therapy, aimed at defining the~     efficacy profile (ORR, CRR and TTP) of pentostatin and cyclophosphamide given in combination~     with Ofatumumab (PCO).~   "
144072|NCT01681550|"~     The use of dipeptidyl-peptidase 4 (DPP-4) inhibitors and glucagon like peptide 1 (GLP1)~     analogues for the treatment of diabetic mellitus (DM) type 2 is growing (1,2). Currently,~     some of these agents have been approved in combination with insulin. The potential for~     combined use with insulin has garnered increasing attention due to reduce side effects~     associated with insulin therapy and improve glycemic control. Some investigators reported~     that GLP-1 analogue combined with insulin reduces HbA1c and weight with low risk of~     hypoglycemia and high treatment satisfaction (3). However, their duration of treatment was~     short time with less than a mean of 3.0 years and the alterations of chronic diabetic~     complications by combination with incretin-based and insulin therapies are not known.~      We evaluated the long effects of adding incretin-based therapy (DPP-4 inhibitors or GLP-1~     analogues) to insulin therapy on glycated hemoglobin (HbA1c) as glycemic control, body mass~     index (BMI), blood pressure (BP), insulin dosage, frequency of hypoglycemia, and chronic~     diabetic complications for 5 years-treatments.~   "
144073|NCT01681537|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational combination of drugs. Phase I studies also try to define the appropriate~     dose of the investigational combination of drugs to use for further studies.~     Investigational means that the combination of drugs is still being studied and that~     research doctors are trying to find out more about it. It also means that the FDA has not~     approved this combination of drugs for AML. As part of this research study, you will take~     lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are~     commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with~     multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered~     investigational in this research study because it is not approved by the FDA for patients~     with AML.~      Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or~     IMID. This drug is successful in the treatment of patients with multiple myeloma and some~     patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that~     lenalidomide may also be effective in patients with AML. Since we know that many patients who~     receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia),~     we are studying the addition of lenalidomide to MEC.~      In this research study, we are looking for the highest dose of lenalidomide that can be given~     safely with MEC.~   "
144074|NCT01681524|"~     The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to~     determine if the study drug in PET imaging is better than SPECT imaging currently used for~     this purpose.~   "
144075|NCT01681511|"~     The primary objective of this pilot study is to demonstrate the feasibility of recruiting~     eligible patients for the purposes of assessing the temporal aspects and rates of Catheter~     Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that~     the numbers needed for a pivotal study can be better estimated.~   "
144076|NCT01681498|"~     This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the~     feasibility of extracting fECGs in a volunteer population.~   "
144100|NCT01681186|"~     This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the~     safety and side effects of LY2940680 in healthy people. Part A will involve two groups of~     participants, each taking up to two single doses of LY2940680 at different dose levels. There~     is a minimum 14 day washout period between each of the participant's doses. The purpose of~     Part B is to study how much of the study drug, in capsule or tablet form, gets into the~     bloodstream and how long the body takes to get rid of it. In addition, the effect of food and~     a proton pump inhibitor on LY2940680 will be studied. Part B will involve one group of~     participants who will take four single doses of 100 mg LY2940680. There is a minimum 7 day~     washout period between doses. Participants may only enroll in one part. Screening is required~     within 28 days prior to the start of the study.~   "
144077|NCT01681485|"~     Lung cancer has been the leading cancer worldwide, which can be divided into small cell lung~     cancer (SCLC) and non-small cell lung cancer (NSCLC) based on biology, therapy, and~     prognosis. NSCLC accounts for more than 85% of all lung cancer cases and has a poor prognosis~     with only 15% of all lung cancer patients alive 5 years or more after diagnosis.~      Traditional Chinese medicine (TCM) originated from Chinese philosophy is a different medical~     system from conventional western medicine. It focuses on health maintenance and emphasizes on~     harmonizing the imbalance of body. Current studies show that TCM has the advantages of~     increasing the sensitivity of chemo- and radio-therapeutics, reducing the side effects and~     chemo- and radio-therapeutics associated complications, improving patients' quality of life~     and survival time. However, how TCM can work with conventional medicine for the treatment of~     carcinoma is still an important research topic worldwide. Syndrome, the essential concept in~     TCM theory, is a diagnostic conclusion of the pathological changes at a certain stage of a~     disease, including the location, cause, and nature as well as the trend of development.~      This study aims to investigate the distribution of TCM syndromes, the changing pattern among~     NSCLC patients before and after having surgery, chemotherapy and radiation therapy, and the~     correlations with patient quality of life and progression free survival. The results are~     important for establishing guidelines for TCM practice and research in future.~   "
144078|NCT01681472|"~     The purpose of this study is to compare the concentration of [6R] 5,10-methylene-THF,~     5-formyl-THF, 5-methyl-THF and THF in the tumor, in adjacent mucosa and in plasma in patients~     with colon cancer receiving two different does of Modufolin® and Levoleucovorin (Isovorin®)~     respectively (60 and 200 mg/m2).~   "
144079|NCT01681459|"~     In lean subjects, free fatty acid (FFA) promotes gut hormone release, delays gastric~     emptying, and reduces appetite and energy intake more than an isocaloric load of triglyceride~     (TG). In obesity, the gastrointestinal sensitivity to food components may be reduced. In this~     study, the investigators compare the effects of the FFA oleic acid and the TG olive oil on~     gut hormone secretion, gastric emptying, appetite sensation, and subsequent energy intake in~     lean and severely obese subjects.~   "
144080|NCT01681446|"~     The purpose of the study is to determine whether interferon-alpha is effective in the~     treatment of low miR-26 expression patients with HCC after curative resection.~   "
144081|NCT01681433|"~     This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427 to~     continuing abiraterone acetate and prednisone treatment in men with metastatic~     castrate-resistant prostate cancer (MCRPC) who have prostate-specific antigen (PSA)~     progression~   "
144082|NCT01681420|"~     Conduct a randomized controlled trial (RCT) to test the hypothesis that offering~     client-centered HIV counseling and testing (HCT) to blood donor candidates will reduce the~     risk of HIV contamination in the blood supply and also increase appropriate referrals to~     preventive and care services to persons in need in São Paulo, Brazil.~   "
144083|NCT01681407|"~     A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in~     depressive patients, treated with SSRI medications. It is an observational clinical~     bio-markers laboratory controlled research with no device.~      The research includes two groups; one for patients diagnosed of having depression, and will~     get a standard SSRI medication regimen. Second group is for control subjects without~     depression. An option for a third group is planned to include first degree relatives of the~     depressed patients. After giving their informed consents, subjects and patients will go~     through standard clinical psychiatric interview, and routine clinical lab tests. Clinical~     standard, specific depression and anxiety questionnaires will be held at four follow-up~     meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. Subjects and patients will be asked~     to give blood samples at these points of time for the lab processing: Complete plasma~     proteomics and specific micro-RNA levels.~   "
144084|NCT01681394|"~     It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce~     blood pressure. However, the mechanisms implicated in these effects have not been elucidated~     yet. The purpose of this study is to evaluate changes in gene expression induced by the~     administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells~     (PBMC) in humans.~   "
144085|NCT01681381|"~     This is a prospective, multi-center, open label, randomized study to evaluate the efficacy~     and safety of The TIVOLI Biodegradable polymer Rapamycin-Eluting Stent comparing with The~     FIREBIRD2™ Rapamycin-eluting Stent (DES) for Treatment Coronary Revascularization.~   "
144086|NCT01681368|"~     Background:~      - Birinapant is an experimental cancer treatment drug. It removes certain proteins in cells,~     which helps to kill the cells. The drug is more likely to cause the death of cancer cells~     than normal cells because cancer cells have more of these proteins. Studies suggest that it~     can help treat ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.~     Researchers want to see how well Birinapant works against the three types of cancer.~      Objectives:~      - To test the effectiveness of Birinapant for ovarian, primary peritoneal, or fallopian tube~     cancer.~      Eligibility:~      - Women at least 18 years of age who have ovarian, primary peritoneal, or fallopian tube~     cancer that has not responded to standard treatment.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected. Tumor tissue samples may be collected before treatment.~          Imaging studies will also be performed.~        -  Participants will have an infusion of Birinapant once per week for 3 weeks in a row,~          followed by a break for a week on the fourth week. This 4-week schedule is one cycle of~          treatment.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Another optional tumor biopsy will be collected 6 weeks after the start of treatment.~        -  Treatment will continue as long as the cancer does not grow and the side effects are not~          severe.~   "
144087|NCT01681355|"~     This study is initiated to investigate the gastrointestinal tolerance of a new infant formula~     in healthy, term, Asian infants.~   "
144118|NCT01680952|"~     This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) +~     Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil~     in Kidney Transplant Patients.~   "
144252|NCT01679210|"~     The overall goal of this randomized controlled trial is to test the efficacy of a culturally~     and linguistically modified, individually-tailored lifestyle intervention to reduce risk~     factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a~     history of abnormal glucose tolerance during pregnancy.~   "
144088|NCT01681342|"~     Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment~     for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a~     combination of external beam radiation therapy and intracavitary treatment. Low dose rate~     intracavitary brachytherapy treatment is already well studied. But high dose rate~     brachytherapy is a relatively new alternative.~      In brachytherapy, major developments have been made in the integration of 3D imaging and~     computerized 3D treatment planning. Medical imaging improvements allowed for better~     definition of tumoral volumes and organs at risk.~      The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of~     these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of~     volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis,~     small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix~     cancer. However its use is not easy in many brachytherapy departments.~      This study will evaluate the feasibility and sparing of organs at risk for high dose rate~     brachytherapy if volume delineation is done at each of the two sessions performed with 3D~     RMN.~   "
144089|NCT01681329|"~     Generalized Anxiety Disorder (GAD) is a condition characterized by chronic and excessive~     worry and anxiety. Our group has developed a cognitive-behavioural treatment (CBT) for GAD~     that has been tested in four previous clinical trials. The findings show that 60 to 70% of~     affected individuals attain GAD remission and that 50 to 55% achieve high endstate~     functioning following the treatment. Although these numbers are encouraging, there remain a~     considerable proportion of individuals who do not fully benefit from treatment. In our most~     recent CIHR-funded treatment study, we assessed the impact of information processing on the~     efficacy of CBT for GAD. Our findings show: a) that the tendency to negatively interpret~     ambiguous information at pre-treatment was associated with greater GAD symptoms at~     post-treatment; and b) that patients who were less successful at changing their negative~     interpretation style were also less responsive to CBT. Given that computerized interpretation~     modification training has been shown to be effective for decreasing the negative~     interpretation style of anxious individuals, the goal of the current proposal is to determine~     whether such training can augment the efficacy of CBT for adults with GAD. A total of 138~     individuals with a primary diagnosis of GAD will be randomly allocated to one of two~     conditions: a) CBT plus interpretation modification training or b) CBT plus non-active~     training. CBT will consist of 14 weekly sessions, with interpretation modification training~     (or non-active training) administered prior to each session. Measures of GAD symptoms,~     psychopathology, cognitive vulnerability, and interpretation style will be administered at~     pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study~     will provide information about the efficacy, clinical usefulness, and mechanisms of~     interpretation modification training in combination with CBT.~   "
144090|NCT01681316|"~     The purpose of this study is to evaluate the effect of Danhong Injection on the relief of~     angina with the use of the Seattle Angina Questionnaire among patients with stable angina~     patients~   "
144091|NCT01681303|"~     Recent research work has directed especial attention toward a distinct group of uremic~     retension molecules, called protein-bound uremic toxins. The prototypes of this group of~     uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production of~     free radical and impair antioxidant system and exerts direct toxicity on different cells and~     organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of these~     protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis of~     kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic~     patients. In hemodialysis, high serum p-cresol level is associated with higher cardiovascular~     mortality.~      AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It has~     superior adsorption ability for certain small-molecular weight organic compounds known to~     accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of~     AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it was~     reported that AST-120 suppressed the increase in serum creatinine levels, prevented~     proteinuria, improved uremic symptoms, and, consequently, led to the postponement of dialysis~     therapy.~      Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized~     AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the~     morbidity- mortality of CKD patients.~      The principal aim of this prospective cohort study is to investigate the effectiveness of~     AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of~     this relationship can help to establish new therapeutic strategy in the treatment of~     late-stage CKD patients.~   "
144092|NCT01681290|"~     The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated~     synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type~     1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy~     (DPN).~   "
144093|NCT01681277|"~     The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics~     of multiple rising doses of BI 113608 in healthy male volunteers~   "
144094|NCT01681264|"~     Dual medication (guanfacine and morphine) as a standard treatment for chronic pain.~   "
144095|NCT01681251|"~     The management and delivery of intravenous fluids during surgical operations is one of the~     important duties for anesthesiologists.~      The goal of this study was to determine if goal directed fluid therapy, titrated using the~     FloTrac monitor's measurement of stroke volume variation results in a decrease in the length~     of stay of patients undergoing open abdominal aneurysm repair.~   "
144096|NCT01681238|"~     There is growing evidence that the risk of postoperative complications can be decreased by~     optimizing the amount and type of infusion fluids given during surgery, steered by~     goal-directed therapy based on flow-related hemodynamic parameters, particularly in high-risk~     patients. This study is undertaken subsequently to test the hypothesis that the~     intraoperative goal-directed strategy based on FloTrac/Vigileo, a minimally invasive monitor,~     can partially prevented postoperative complications and shorten hospital stay in the elderly~     high-risk patients undergoing total hip replacement with continuous spinal anaesthesia .~   "
144097|NCT01681225|"~     This phase II multi-centered, randomized controlled trial of mechanical ventilation directed~     by esophageal pressure measurement will test the primary hypothesis that using a strategy of~     maintaining a minimal but positive transpulmonary pressure (Ptp = airway pressure minus~     pleural pressure) throughout the ventilatory cycle will lead to an improvement in patient~     survival.~   "
144098|NCT01681212|"~     The purpose of this study is to determine the survival rate after 1 year of treatment with~     ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable) or~     Stage IV melanoma.~   "
144099|NCT01681199|"~     The study is designed to assess the effect of statin on atherosclesrosis progression as well~     as to explore its potential mechanism besides lipid modifying , such as effect on~     inflammation and vascular calcification.~   "
144101|NCT01681173|"~     High intake of insoluble fiber is strongly associated with a reduced incidence of diabetes~     and cardiovascular events in prospective observation studies. Our primary objective is to~     compare a life style diabetes prevention program(PRAEDIAS) with and without added insoluble~     fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals with~     impaired glucose tolerance. Subjects with IGT not willing to participate in the intervention~     will be used as independent controls. Secondary aims are to identify mechanisms of action~     with regard to body composition, anti-inflammatory and metabolic effects of fibers. We~     propose a randomized, prospective intervention study. The results will be of general~     relevance for guidance of fiber intake in the population and will help the food industry to~     design healthy high fiber foods. Fiber can be added at low cost to numerous foods. Increased~     fiber intake may therefore provide a simple non-cognitive prevention strategy effective at~     the population level.~   "
144102|NCT01681160|"~     This study was a Kind of clinical trial with equal randomization, that have been done from~     January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128~     diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is~     one of the more important aims for health professional specially for nurses.One of this new~     treatment is maggot therapy.~   "
144103|NCT01681147|"~     The purpose of this study is to find out whether women who have had gestational diabetes will~     make healthier lifestyle choices, achieve weight goals, and complete postpartum care~     assessments after receiving two online classes on healthy nutrition and exercise classes at 6~     weeks - 3 months and at 9 months postpartum.~   "
144104|NCT01681134|"~     The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects~     (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.~   "
144105|NCT01681121|"~     This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in~     the treatment of excessive daytime sleepiness in adults with narcolepsy.~   "
144106|NCT01681108|"~     The purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for~     children and adolescents to lose weight and promote their self esteem in a fun atmosphere.~   "
144107|NCT01681095|"~     The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold~     cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic~     arrest.~   "
144108|NCT01681082|"~     The general purpose of this study is to examine the effect of tai chi training on cognitive~     function in young adults. The investigators will test subjects enrolled in a semester-long~     tai chi course along with control subjects. The specific aims are to measure duration of~     practice, cognitive function, physical balance, and Attention Deficit Hyperactivity Disorder~     (ADHD) indicators. The investigators primary hypotheses are that, compared to controls,~     subjects in the tai chi course will show improvements in (1a) spatial working memory and (1b)~     response inhibition. The investigators secondary hypotheses are that, among the subjects~     participating in the tai chi course, these cognitive improvements will correlate with (2a)~     improvements in balance and (2b) duration of tai chi practice, and that, among all~     participants, (2c) ADHD indications will correlate with cognitive measures.~   "
144109|NCT01681069|"~     Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the~     subjects' body weight, body fat and safety parameters are monitored~   "
144110|NCT01681056|"~     The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality~     of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is~     quality of life.~      The hypothesis of this study is that autosuggestion will increase geriatric patient's quality~     of life based on its impact to psycho-neuro-endocrine-immune pathways.~   "
144111|NCT01681043|"~     Sleep investigation in respirator treated ICU patients: the importance of intensive~     environment.~      Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and~     increased mortality.~      The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise,~     light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep~     quality in respirator treated ICU patients.~      Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc.~     AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary~     circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m.~     after randomization.~   "
144112|NCT01681030|"~     This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of~     EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture~     line bleeding in cardiovascular surgery.~   "
144113|NCT01681017|"~     The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality~     (fresh stillbirths or early neonatal deaths) among births > 1500g of training birth~     attendants at health facilities in the Helping Babies Breathe (HBB) and Essential Newborn~     Care (ENC) curricula. These facilities are located within clusters in the Global Network for~     Women's and Children's Health Research sites in Belgaum and Nagpur, India, and Eldoret,~     Kenya.~   "
144114|NCT01681004|"~     The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis~     (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of~     the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo~     specific, targeted non-surgical treatment of the SI joint.~   "
144115|NCT01680991|"~     This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety~     of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+)~     malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated~     time on study treatment is 24 weeks.~   "
144116|NCT01680978|"~     A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to~     assess the effect of aleglitazar on cardiac energetics and function in patients with~     uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are~     drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg~     aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients~     will cross over to the treatment not yet received.~   "
144117|NCT01680965|"~     To study the safety and side effects of Ofatumumab in the treatment of chronic~     graft-versus-host disease (GvHD). This study will also evaluate effectiveness of Ofatumumab~     when added to standard steroid treatment for chronic graft-versus-host disease~   "
144119|NCT01680939|"~     Every year thousands of young children with obstructive sleep apnea undergo surgery which~     requires them to be prescribed pain medication. The current standard in North America is~     administration of opioids, mainly codeine or morphine; however in many areas of the world~     including Canada, nonsteroidal anti-inflammatory medications such as ibuprofen are used. Some~     North American surgeons are uncertain regarding the potential of ibuprofen to increase~     bleeding following surgery. The results of research studies have been inconclusive overall.~     Due to recent codeine fatalities in children following adenotonsillectomy, codeine has been~     removed from the formulary at many Pediatric institutions. Some surgeons have begun to use~     oral morphine as an alternate to codeine, which necessitates the need to find safe~     alternative analgesics in this treatment group.~      The primary objectives of this study is to assess the safety(1) and efficacy (2) of morphine~     and ibuprofen in children with sleep apnea.~      An interim analysis will be conducted after recruitment of 70 patients, to monitor both~     safety and efficacy~   "
144120|NCT01680926|"~     Overweight patients with type 2 diabetes are often being treated with an intensified insulin~     therapy. However, in many cases, even a high insulin dosage (> 100 U per day) does not~     achieve satisfying metabolic control. A new therapy option is necessary that makes it~     possible to lower the daily insulin requirement and to improve metabolic control. The aim of~     this study was to investigate whether a protein-rich meal replacement is suitable to lower~     the daily insulin requirement and to reduce HbA1c and body weight.~   "
144121|NCT01680913|"~     Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In~     obese patients, the commonly used landmarks may be difficult or even impossible to feel. In~     addition, the spine can be hidden beneath a layer of fatty tissue.~      Ultrasound is useful for finding the correct injection site in pregnant patients, but the~     usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The~     potential benefits for obese patients from the use of ultrasound include shortening the~     duration of the procedure, increasing patient comfort, decreasing the total number of~     attempts, and aiding in the choice of appropriate needle length for the patient.~      The investigators hypothesize that there is no difference in time to perform a spinal~     anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients~     with BMI > 35.~   "
144122|NCT01680900|"~     This is a pilot study to determine proof in principle that vilazodone, a selective serotonin~     reuptake inhibitor and 5HT1a agonist, reduces the frequency and severity of menopausal hot~     flashes relative to placebo. A secondary aim is to evaluate improvement in menopause-related~     quality of life.~   "
144123|NCT01680887|"~     This is a double-blind placebo-controlled clinical trial (n = 200) of varenicline for the~     treatment of cocaine dependence that utilizes contingency management to promote treatment~     attendance.~   "
144124|NCT01680874|"~     The purpose of this study is to determine whether a probiotic, when used together with~     standard treatment, is effective in reducing duration of symptoms and preventing recurrence~     of infection in older adults with a first episode of C. difficile infection.~   "
144125|NCT01680861|"~     A recent therapeutic strategy following renal transplantation includes simultaneous use of~     reduced calcineurin inhibitor (CNI) dosing and maximized use of a non-nephrotoxic,~     antiproliferative drug (inosine monophosphate dehydrogenase (IMPDH) or TOR inhibitor), with~     the goals of reducing/avoiding CNI nephrotoxicity, the incidence of acute rejection, and~     chronic allograft injury (CAI) (i.e., interstitial fibrosis/tubular atrophy), leading to more~     favorable longer-term patient and graft survival.1-7 Early corticosteroid withdrawal has also~     been used in the attempt to avoid well-known side effects while maintaining favorable patient~     and graft survival.8-10 While the investigators center and numerous other centers have also~     included single agent, antibody induction utilizing the lymphodepleting polyclonal antibody~     rabbit anti-human thymocyte globulin (ATG), nondepleting human anti-interleukin-2 receptor~     (CD25) monoclonal antibody daclizumab (Dac) or basiliximab, or lymphodepleting humanized~     anti-CD52 monoclonal antibody alemtuzumab,11-17 evidence now suggests that an even more~     effective induction strategy may include the combined use of more than one induction agent~     (each with fewer doses than if used alone), with the goal of bringing the kidney transplant~     recipient even closer (through more effectively timed lymphodepletion) to an optimally~     immunosuppressed state, allowing further reduction in long-term maintenance drug dosing.18-25~     The investigators have now successfully used dual ATG/Dac induction therapy in both~     kidney-alone23-24 and simultaneous kidney-pancreas (SPK) transplantation,18-20 and a recent~     report from the investigators center of kidney-alone and SPK recipients shows that the~     addition of anti-CD25 to ATG for induction therapy more effectively delays the return of~     peripheral blood CD25+ cells.25 In the kidney-alone recipient study 3 doses of ATG were~     combined with 2 doses of Dac for induction,23-24 vs. the investigators previous studies~     utilizing single agent induction with 7 doses of ATG or 5 doses of Dac.4,16,17 Successful~     combination of ATG/basiliximab as dual induction in kidney transplantation has also been~     reported elsewhere,21-22 along with equivalency in clinical outcomes using daclizumab vs.~     basiliximab.13~   "
144126|NCT01680848|"~     The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for~     diagnosis, treatment, and prevention of dental caries.~   "
144127|NCT01680835|"~     This post-approval study is designed to confirm the long-term safety and effectiveness of the~     EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial~     femoral artery (SFA) and proximal popliteal arteries.~   "
144128|NCT01680822|"~     Little is known about the disease caused by the nontuberculous or environmental mycobacteria~     (NTM) and only limited data are available showing treatment outcome. This project will study~     the patients with nontuberculous mycobacterial (NTM) diseases in the University of Illinois~     Hospital & Health Sciences System (UIMC). The aim of study is finding treatment outcome and~     risk factors that are associated with treatment failure in NTM patients. This is a~     retrospective, observational study for collecting data on patients with NTM in UIMC. The~     study initially involves populating the study of NTM patients seen at UIMC during the study~     period. This will add our knowledge about current treatment outcome of patients with NTM~     diseases and will be of interest to physicians, and public health authorities.~   "
144129|NCT01680809|"~     This study seeks to determine if compliance with compression therapy is increased in patients~     with healed venous insufficiency ulcerations when lower levels of compression therapy are~     prescribed. This study will measure compliance with compression therapy at low levels of~     compression. It will also seek to determine if compression therapy aids in the prevention of~     venous insufficiency ulcer recurrence.~   "
144130|NCT01680796|"~     This is an open-label phase I study in which dovitinib is given in combination with~     bortezomib and dexamethasone. Dovitinib dose escalation is planned in order to determine its~     maximum tolerated dose when given in this combination.~   "
144131|NCT01680783|"~     The objective of our study is to evaluate the efficacy of helmet ventilation as compared with~     Face mask in patients with respiratory failure.~   "
144132|NCT01680770|"~     The objective of our study is to determine the correlation of transthoracic ultrasonographic~     indices of fluid responsiveness to changes in direct measures of cardiac output and to~     compare them to other established predictors of fluid responsiveness such as central venous~     pressure variation, systolic arterial pressure variation and pulse pressure variation in a~     broad population of patients.~      Hypothesis: There will be a significant difference in the inferior vena cava respiratory~     variation and subclavian vein respiratory variation between responders and non-responders to~     intravenous fluid challenge in a broad population of patients with shock.~   "
144133|NCT01680757|"~     This study is a prospective, multicenter, non‐randomized trial of a stand‐alone procedure for~     left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic~     events who are contraindicated for or intolerant of oral anticoagulation therapy. This study~     will enroll 100 participant, who will receive the LAA ligation study treatment. The objective~     of this registry is to assess the effectiveness of permanent exclusion of the LAA using the~     LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard~     anticoagulation therapy. The results of the study will be used to assess outcomes within the~     first year, post‐treatment.~   "
144134|NCT01680744|"~     To protect kidney function during the transplantation process by inducing mild hypothermia in~     the deceased organ donor before organs are recovered~   "
144135|NCT01680731|"~     The purpose of this study is to investigate of the differences in pelvic floor anatomy and~     function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a~     forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women~     within 1-5 years after first delivery who did not have an internal delivery will be included.~     The total number of subjects is forty. This will include ten primiparous subjects who have~     undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous~     vaginal delivery and ten who have undergone primary elective cesarean section.~   "
144136|NCT01680718|"~     It has long been established that interpersonal relationships can have a profound impact on~     health and well-being. Yet, we are still learning about the complex biological processes that~     contribute to positive social interactions and the ability to develop and maintain social~     relationships. Recent research has begun to focus on oxytocin and vasopressin, neuropeptides~     that are naturally produced in the hypothalamus, because administration of these~     neuropeptides has been associated with increased trust, generosity, empathy, cooperation,~     memory of social stimuli (e.g., faces), and brain activity in neural regions associated with~     social and emotional processes. To date, several aspects of oxytocin and vasopressin's~     effects on social behavior have been unexplored. As such, the overarching goal of this~     project is to examine the effects of intranasal oxytocin and vasopressin on social working~     memory, deception detection, sensitivity to interpersonal distance, empathy, and altruistic~     behavior. Understanding how oxytocin and vasopressin influence these aspects of social~     functioning will help to inform research that has begun to establish the potential for use of~     these neuropeptides in psychiatric disorders such as autism spectrum disorders and~     schizophrenia that are characterized by social deficits. For this study, we will recruit 150~     healthy adults without a history of medical or psychiatric illness to come to the laboratory.~     In the first session, participants will complete several questionnaires. In the second~     session, participants will be randomly assigned to receive oxytocin, vasopressin, or placebo.~     The study nurses will measure temperature, heart rate, and blood pressure (female~     participants will also be asked to undergo a pregnancy test) before drug administration.~     Participants will then complete computer tasks. During the second session, we will also~     collect a saliva sample for genetic analysis and participants will be asked to complete~     several additional questionnaires. At the end of the experimental session, participants will~     be fully debriefed.~      The investigators hypothesize that compared to placebo, oxytocin and/or vasopressin will~     improve social working memory and deception detection, and increase empathy and altruism. It~     is also hypothesized that main effects will not be found for oxytocin or vasopressin, but~     rather, analyses of relevant moderators will elucidate these findings.~   "
144137|NCT01680705|"~     The aim of this study is to determine what the ideal frequency of high-volume sinonasal~     saline irrigation in the early postoperative period following ESS for medically refractory~     CRS. We will evaluate once, twice, and three times daily frequency sinonasal saline~     irrigation protocols. Our hypothesis is that three times a day sinonasal saline irrigations~     for the first week is ideal with no difference between frequencies after 1 week.~   "
144138|NCT01680692|"~     The purpose of this study is to evaluate whether a new regional anesthesia technique would~     provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot~     drop after knee replacement surgery.~   "
144139|NCT01680679|"~     Influenza viruses are significant causes of human illness and death in developed and~     developing countries. This study will measure the ability of influenza vaccine given to~     children in India to protect both the children and unimmunized persons around them from~     influenza. It will also determine whether the best time to immunize in a country like India~     that has both summer and winter outbreaks of influenza is in the fall, as is done now, or~     whether immunization should be in the spring to protect against influenza infections in the~     summer.~   "
144140|NCT01680666|"~     The investigators hypothesized that, in children undergoing venous cannulation for central~     line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in~     successful venous cannulation at first attempt compared to landmark guided cannulation.~   "
144141|NCT01680653|"~     The incidence of low blood sugar and hypoglycemic seizures at diabetes camp has been reduced~     thanks to overnight blood glucose level testing. The timing of the overnight blood test is~     often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic events~     at camp are occurring. It is also unclear what the most appropriate treatment for nocturnal~     hypoglycemia is: simple carbohydrates, or mini-glucagon.~      In this study, we will use Continuous Glucose Monitors (CGMs) that will send subject data~     securely to a remote computer located in the medical cottage at camp throughout the night.~     Study staff will monitor the computer and will intervene on low blood sugar as it occurs in~     real time. On half of the nights, campers will receive mini-glucagon for low blood sugar, and~     on the rest, they will receive standard carbohydrate treatment.~   "
144158|NCT01680432|"~     Constipation is a common gastrointestinal motility disorder, chronic condition that often~     negatively affects the daily lives of patients due to their symptoms, such as infrequent~     stools, hard stools, straining or painful defecation, cramping, bloating and flatulence.~     Stress, poor diet and sedentary lifestyle are part of modern lifestyle, which contributes to~     the onset of constipation. One way to reduce constipation through nutritional management of~     affected individuals is through consumption of probiotic products, which beneficially affect~     the development of microbial flora in the intestine, helping to improve the symptoms of~     constipation. Among these foods, the market is a fresh cheese, plus Bifidobacterium lactis,~     which according to its maker, when consumed as part of a healthy diet, presents beneficial~     effects in improving symptoms of constipation.~      Hypothesis: The fresh cheese enriched with Bifidobacterium lactis relieves symptoms~     constipation.~   "
144142|NCT01680640|"~     Non-alcoholic fatty liver disease (NAFLD) is a liver condition in which fat builds up in the~     liver not caused by alcohol. The liver is an organ that is not designed to build up fat.~     NAFLD is common in people who have too much body fat in their abdomen or who have diabetes~     (high blood sugar), but does not always exist with these conditions. NAFLD can also occur in~     thin people too. NAFLD can be harmful to the liver and may cause the liver to fail over time.~     NAFLD may also cause adult (or type 2) diabetes and also heart disease. In people who already~     have diabetes, NAFLD can cause glucose (sugar) levels to be too high.~      Our intestines (guts) contain healthy bacteria and some harmful bacteria (bugs). This balance~     of healthy and harmful bugs is essential for the normal workings of our intestine to digest~     food. Providing these bacteria do not leak out into the blood they do not cause harm. If the~     balance of healthy to harmful bugs is upset, the harmful can cause problems and leak out into~     the blood. Because the liver is connected to the intestine by blood vessels the harmful~     bacteria can get to the liver and cause problems. These bacteria can cause the liver and the~     body to build up too much fat and might cause NAFLD and obesity. In this study, we will test~     the effects of a supplement (synbiotic) taken during the day, that contains a mixture of~     'good' healthy bacteria (probiotic) and a sugar (prebiotic) that is not broken down and~     absorbed into the blood. We will test whether the synbiotic supplement has beneficial effects~     on the NAFLD liver condition and on factors linked to too much body fat, diabetes and heart~     disease.~   "
144143|NCT01680627|"~     The purpose of this research is to examine the effectiveness of the Computerized Alcohol~     Screening and Brief Intervention (CASI) in adolescent patients in the Emergency Department at~     the UC Irvine Medical Center. This research study will evaluate the effectiveness of the~     brief intervention compared to standard of care (no intervention). Brief interventions have a~     high potential impact in ED. Computerized alcohol screening and brief intervention (CASI) is~     a fast and easy to use tool for patients and healthcare providers. CASI provides the Alcohol~     Use Disorders Identification Test (AUDIT-C)4, from the World Health Organization and CRAFFT3,~     followed by a brief intervention and customized alcohol intake recommendations for the~     patient. This study will also determine the effectiveness of the brief intervention in~     reducing alcohol use/abuse in adolescents between 12-17 years of age.~      The overall goal of this study is to identify at risk alcohol use/abuse in adolescents and~     provide an intervention at an early stage. The current data to support alcohol and screening~     and brief intervention in adolescents is limited. The researchers hope that this research~     study will add to the overall body of knowledge in support of using the emergency department~     as a tool in public health, as it relates to the individual patients morbidity and mortality~     (pancreatitis, cirrhosis) and to the societal costs of alcohol use (lost days of work, motor~     vehicle collisions).~   "
144144|NCT01680614|"~     The purpose of this research is to examine the effectiveness of computerized alcohol~     screening and brief intervention in the UC Irvine Medical Center Emergency Department (ED)~     and Trauma Patients. Brief interventions have a high potential impact in ED and Trauma~     populations. Computerized alcohol screening and brief intervention (CASI) is a fast and easy~     to use tool for patients and healthcare providers. CASI mitigates barriers to proper~     screening and intervention, including time, availability of trained personnel, patient~     comfort, and language barriers. CASI provides the Alcohol Use Disorders Identification Test~     (AUDIT) followed by a brief intervention and customized alcohol intake recomendations for the~     patient.~      The intervention of this study will be the addition of a brief CASI questionnaire to the~     standard of care for a random subset of subjects. All subjects who screen positive for~     hazardous alcohol use will be followed up and reassessed for alcohol use. The researchers~     hypothesize that the addition of CASI will lead to a decrease in alcohol intake within three~     months. The basis of this research is evidence of the effectiveness in the CASI system, the~     growing public health issue of alcohol abuse, the need to be able to provide effective~     screening and brief intervention in the high volume ED settings, and findings that the~     primary method to reduce traumatic death is prevention.~   "
144145|NCT01680601|"~     Surgical correction of congenital heart defects in children requires the utilization of~     cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions~     during surgery. During this process the patient´s circulation is controlled by a bypass~     machine which provides several functions:~        1. Controls the patient's blood flow by pumping of blood in the patient's body.~        2. Controls the correct oxygen levels in the patient's blood.~        3. Regulates the temperature and fluid level of the blood. This process triggers negative~          responses in the heart and throughout the whole body, potentially resulting in injury to~          the heart and other organs such as brain, kidneys and lungs.~      Remote ischaemic preconditioning (RIPC) describes a procedure that could potentially reduce~     the injury to heart muscle during cardiac surgery. The procedure consists of the inflation of~     a blood pressure cuff on the child's leg for three 5 minute cycles. This process acts by~     briefly reducing blood flow to the leg muscle, which will then activate the body´s own~     protective mechanisms and thereby reduce heart injury.~      Several animal studies have been used to help the understanding of the mechanisms behind this~     process, and trials in human adults have showed optimistic results; however evidence~     regarding the paediatric population is limited and necessary since children present different~     basal profiles, risks and requirements.~      The investigators propose a randomized clinical trial assessing the efficacy of RIPC to~     provide protection against injury to the heart and other organs in children going through~     cardiac surgery using CPB at the Royal Hospital for Sick Children. The research project will~     have a translational approach, integrating basic molecular mechanisms to clinical outcome.~     The investigators hope it will allow the understanding and utilisation of the patient´s own~     protective mechanisms, reducing CPB-related injury and ultimately improving patient outcome.~   "
144146|NCT01680588|"~     This is a phase 2, open-label, multiple-center, non-randomized single dose study to assess~     the safety and efficacy of [18F]NAV4694 PET imaging in detecting beta-amyloid plaque in the~     brain in subjects with probable AD compared with healthy volunteers.~   "
144147|NCT01680575|"~     To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia~     induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian~     cancer and to validate this model.~   "
144159|NCT01680419|"~     An urgent and growing need exists for interventions that support the long-term adjustment and~     mental health needs of OIF/OEF veterans and their relationship partners after the return from~     deployment. This project will complete production of a multimedia intervention program for~     autonomous use, delivered by Internet and mobile app technology, that teaches couples~     selected mind/body interventions and massage techniques to promote stress reduction,~     compassion, resiliency and relationship re-integration. A four-armed randomized trial will~     evaluate mental health outcomes as a free-standing program and as complementary to a current~     standard of care structured group program.~   "
145825|NCT01658371|"~     Genetic polymorphism affects plasma concentration of antiretroviral therapy in HIV patients.~     The investigators investigate the prevalence of genetic polymorphism affecting efavirenz~     metabolism and the corresponding pharmacokinetics of different genotypes.~   "
144148|NCT01680562|"~     In vivo differentiation of benign and malignant skin lesions is a fundamental issue in~     clinical dermatology. Malignant skin diseases are known to be accompanied by structural~     alterations. Conventional excisional biopsies and further histopathology are regarded as the~     reference standard for investigating these pathologies. Biopsies are invasive procedures and~     additionally may cause side effects. Therefore, research efforts are focused on the~     development of diagnostic techniques capable of providing in vivo information on the skin's~     structure. Optical coherence tomography (OCT) is a technical application, which allows the~     identification of microscopic patterns indicative for benign and malignant skin lesions. OCT~     is a promising noninvasive imaging technique for the micromorphology of the skin. So far,~     it's clinical application, as an additional diagnostic tool for malignant skin lesions has~     been studied in a limited extend. To evaluate the clinical usefulness of OCT, we conducted a~     prospective pilot study at the Department of Dermatology, Medical University of Vienna. The~     study is in cooperation with the Center of Biomedical Engineering and Physics at the Medical~     University of Vienna.~      A total of 70 malignant skin lesions was evaluated during this prospective pilot study.~     Diagnoses based on OCT imaging as an additional diagnostic tool, were compared to those based~     on the clinical standard pathway at the Department of Dermatology, Medical University of~     Vienna. For the purpose of this study, the histopathological diagnosis was used as the~     reference diagnostic standard.~      The major aims of this study is the investigation of the ability of ultrahigh resolution OCT~     to identify fine morphological characteristics associated with basal cell carcinoma, actinic~     keratosis, superficial squamous cell carcinoma, seborrheic keratosis, melanocytic nevi and~     melanoma.~        -  To correlate the morphologic features identified with ultrahigh resolution OCT with~          routine histopathology~        -  To investigate the clinical feasibility of ultrahigh resolution and spectroscopic OCT~          technology~        -  To assess the effectiveness of ultrahigh resolution and spectroscopic OCT imaging to~          diagnose various melanocytic and non-melanocytic skin tumors~        -  To compare the diagnostic capabilities of ultrahigh resolution OCT with standard~          non-invasive diagnostic procedures such as epiluminescence microscopy~   "
144149|NCT01680549|"~     The purpose of this project is to study the effects of gabapentin on pain control in the~     perioperative and post-operative period of total knee arthroplasty.~   "
144150|NCT01680536|"~     The purpose of the study is to investigate the possible benefits of giving the anti-HIV drug~     maraviroc to people who are taking darunavir/ritonavir alone for their HIV treatment. Many~     people successfully take only darunavir/ritonavir treatment for their HIV. However, there are~     some concerns that this treatment may not reach some areas of the body, such as the brain and~     spinal cord (central nervous system or CNS), as effectively as it does the bloodstream.~      There is already a large clinical study looking at any differences between 'conventional' HIV~     treatment with 3 drugs and single drug treatment with a protease inhibitor, also called PI~     monotherapy, such as darunavir/ritonavir. This includes differences in the effects on the~     CNS. However, this study will only be finished in 2013.~      The investigators know that maraviroc can reach the CNS very effectively. The investigators~     in this study will investigate the effect of adding maraviroc to darunavir/ritonavir~     monotherapy by looking at levels of inflammation within the fluid that surrounds the CNS,~     called cerebrospinal fluid or CSF.~      Maraviroc is a licensed drug for the treatment of HIV treatment.. It showed good results in 2~     clinical studies when it was taken by people whose HIV virus had developed resistance to~     previous HIV treatments.~      This study will also investigate safety as well as monitor effectiveness when patients take~     maraviroc is taken on top of normal treatment of darunavir/ritonavir monotherapy.~      Maraviroc has been shown to be present in the fluid that surrounds the brain in people taking~     Maraviroc. It is not known if whether the presence of Maraviroc has any impact on brain~     function. Therefore this study will also investigate brain (neurocognitive) functioning with~     a computer test and some written tests.~   "
144151|NCT01680523|"~     To compare 5-year overall survival between patients who undergo radical hysterectomy followed~     by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO~     stage IB2 and IIA2 cervical cancer~   "
144152|NCT01680510|"~     Retinitis pigmentosa is a genetically disease consisting of progressive retinal degeneration~     starting in the rods. Its prevalence is 1:4000 people and is the fourth most common blinding~     disease in Israel in 2004 [7% of all blindness]. The investigators treated a non-progressive~     form of the disease [Fundus Albipunctatus] by oral therapy of the food supplement made from~     alga Dunaliella Bardawil composed of approximately 50% 9-cis β-carotene. The alga Dunaliella~     Bardawil accumulates high concentration of β -carotene when grown under appropriate~     conditions. The β -carotene of the alga is composed of approximately 50% of all-trans - β~     carotene and 50% 9-cis β -carotene.~      The 9-cis β -carotene has been shown to be a precursor of 9-cis retinoic acid both in-vitro~     in human intestinal mucosa and in-vivo in a ferret, perfused with 9-cis b-carotene. The night~     vision, as measured objectively by electroretinography (ERG) more than doubled in six~     patients tested following treatment. The visual field was also improved significantly. In a~     more recent study the investigators treated 29 retinitis pigmentosa patients with the 9-cis b~     Carotene algae Dunaliella Bardawil in a double masked placebo control cross over trial.~     Significant improvement in retinal function was recorded in 34% of the patients.~   "
144153|NCT01680497|"~     A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM~     VOLIFT™ for the correction of moderate to severe nasolabial folds~   "
144154|NCT01680484|"~     There are multiple factors affecting the variability and acceleration pattern of fetal heart~     rate (FHR) pattern. However, fetal activity is considered as the main determinant. Any factor~     decreasing fetal activity causes a decrease in FHR variability. Fetal activity may be~     stimulated by manual manipulation, sound, light, change in maternal position and maternal~     ingestion of glucose. Among those, ingestion of any kind of food or juice is most frequently~     practiced in outpatient settings. This is not only medical but also a social routine. In this~     study the investigators have chosen the two most popular so-called 'fetal accelerators',~     chocolate and orange juice against no intervention and tried to find any usefulness of these~     on non-reactive NST patterns.~   "
144155|NCT01680471|"~     Sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating~     airway properties, has acquired widespread acceptance in children. However, sevoflurane has~     been reported to be associated with emergence agitation in children, with a reported~     incidence of up to 80%.~      The purpose of this study is to verify that the prophylactic use of midazolam, which is a~     GABA A receptor inhibitor, given five minutes before the end of strabismus surgery reduces~     the incidence of emergence agitation after sevoflurane anesthesia in children.~     Simultaneously, this study aims to find out the proper dose of midazolam with minimum~     disturbance to patient's emergence time.~   "
144156|NCT01680458|"~     To collect the efficacy and safety information of fluconazole on infant subjects related to~     their appropriate use in daily practice.~   "
144157|NCT01680445|"~     The telephone interviews will be conducted to gather information on goal setting and goal~     attainment from men and women with osteoarthritis.~   "
144171|NCT01680263|"~     The aim of this study was to determine the effects of kinesiotaping in comparison to NSAIDs~     and physical therapy in treatment of pes anserinus tendino-bursitis.~   "
144160|NCT01680406|"~     The investigators hypothesize that the addition of primaquine (PQ) to both~     artemether-lumefantrine (AL) and chloroquine (CQ) for the treatment of Plasmodium vivax~     infection will result in decreased chance of relapse by about 60%.~      The investigators plan to assess the therapeutic efficacy of AL compared to combined AL + PQ~     and CQ compared to combined CQ + PQ against P. vivax infection. They also plan to determine~     the number of recurrent vivax episodes in patients receiving PQ compared to those who don't~     receive PQ. Patients aged above 1 year with symptomatic malaria presenting to health centers~     will be enrolled for treatment with AL, AL+PQ, CQ, or CQ+PQ for P. vivax infection.~      Phase 1 of the study will monitor the clinical, parasitological, and hematological parameters~     for P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug~     efficacy. Phase 2 will continue monthly follow-up of these patients for one year to assess~     frequency of recurring vivax infections. Results from this research study will be used to~     assist Ethiopia in assessing their current national malaria drug policies.~   "
144161|NCT01680393|"~     This study is a 3-legged randomized study examining whether during shoulder surgery performed~     in the beach chair position active compressions of the lower leg with a sequential~     compression device (SCD) have a superior effect on stabilizing cerebral and circulatory~     hemodynamics when compared to TED stockings or a control group without any stockings.~   "
144162|NCT01680380|"~     The purpose of this study is to evaluate the feasibility of tracking breathing during sleep~     with non-contact sensors (for example, microphones or wireless movement sensors). The~     investigators will use the data collected with these sensors to develop algorithms for~     tracking breathing during sleep. The investigators will assess the performance of the~     algorithms by comparing automatic output against manually-generated labels.~   "
144163|NCT01680367|"~     This study is to determine what dressing would work best to heal and keep from hurting, the~     split-thickness skin graft donor site which will be done as part of the patient's surgical~     procedure. Currently there is a dressing that is transparent and it is placed on the wound~     after surgery and wrapped with gauze and an elastic bandage. Two days after the surgery the~     gauze and elastic bandages are removed and the area is left with the transparent dressing.~     Sometimes the dressing needs to be changed because it leaks. On the fifth day this dressing~     is removed and the wound is left open to air. The dressing researchers are studying is a~     dressing that has been used for different types of wounds, as well as this type of wound. It~     is applied in the same manner; however, it is left in place until it falls off independently,~     usually around post-operative (post-op) day 10.~   "
144164|NCT01680354|"~     Laser correction for myopia and astigmatism using an excimer laser has been performed with~     success for several years.~      During the last 2 years, a new method for correction of refractive errors has emerged. In the~     method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is~     subsequently removed. For simple myopia this method has proved effective and on par with~     excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the~     treatment of astigmatism.~      In the study, patients with high astigmatism are treated with conventional LASIK for~     astigmatism in one eye and with ReLEx for astigmatism in the other.~   "
144165|NCT01680341|"~     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).~      The aim of the trial is to compare the efficacy and safety of two different titration~     algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes~     mellitus previously treated with insulin glargine.~   "
144166|NCT01680328|"~     This trial is conducted in Europe. The aim of this trial is to assess and describe the pain~     in relation to subcutaneous (under the skin) injection of different combinations of injection~     speed and volume with respect to acceptance of the injection pain and backflow.~   "
144167|NCT01680315|"~     The regulation of our food intake is on the short-term guided by appetite and satiety signals~     generated by the sight and consumption of food. Food intake is not only regulated by appetite~     and satiety signals - external cues also play an important role.~      It has been observed that food intake and the pleasure derived from consumption is affected~     by manipulation of the external cues.~      The investigators will assess the contribution of food anticipation (calorie information) and~     actual consumption of a test food (calorie intake) on in satiety responses (such as ghrelin~     responses, appetite and subsequent food intake). The investigators expect the information on~     the amount of calories, rather than the actual amount of calories in the food, to predict the~     ghrelin responses and the subsequent intake of a second meal.~   "
144168|NCT01680302|"~     This is a substudy of Generation 100. In that study, 4000 healthy persons between 70 and 75~     will be randomised do moderate intensity, high intensity or control group, with 3 years of~     exercise. The investigators will follow these persons and register all who develop atrial~     fibrillation during these 3 years, and at follow-up after ended intervention to see if there~     is differences in the number of persons who develop atrial fibrillation in the 3 groups.~   "
144169|NCT01680289|"~     The aim of this study is to determinate the influence of an alternative adhesive application~     protocol (i.e. consecutive application of an extra adhesive layer)on restoration longevity in~     primary molars.~   "
144170|NCT01680276|"~     Many people with intellectual disability have challenging behaviour which often has serious~     consequences such as the prescription of long term medication, in-patient admissions and~     disruption of normal daily activities. Community intellectual disability services may have~     difficulties in helping people with challenging behavior. Available research suggests that~     Positive Behavior Support (PBS), a training system that teaches staff how to manage these~     situations, can benefit service users who may show improvements in challenging behavior and~     quality of life. The investigators do not know of any study so far that has examined the~     clinical and cost effectiveness of PBS that is provided by staff in routine clinical practice~     in community intellectual disability services. If PBS proved to be better than treatment as~     usual, it would have important implications for the management of a very vulnerable group of~     service users. In this trial, health staff will receive accredited training in PBS available~     in a manual written by PBS experts. It will give details of how to understand challenging~     behavior and develop a management plan and how to implement it and monitor whether it has~     achieved its goals. Twenty community intellectual disability services and 260 service users~     with mild to severe intellectual disability and challenging behavior will be invited to take~     part in the study. The sample size calculations are based on our pilot study and allow for~     non participation of 10% and inflation due to the number of community intellectual disability~     teams and staff that will take part. The teams will be randomly allocated into one of two~     conditions. Half will be in the PBS arm (but will also have treatment as usual) and half will~     be in the treatment as usual only group. The investigators will carry out assessments of~     challenging behavior, use of services, quality of life, mental health, aggression and family~     and paid carer burden at six and 12 months. The investigators will monitor treatment fidelity~     and the investigators will talk to a sample of paid and family carers, service users, staff~     and managers about what they think of the treatment and how best the investigators can~     deliver it in routine care. The main outcome is reduction in challenging behavior at one year~     after the randomization. The investigators will also carry out a health economic evaluation~     to examine the costs and consequences of staff training in PBS.~   "
144173|NCT01680237|"~     Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety~     disorders. Although the efficacy of psychological treatment for panic disorder with~     agoraphobia has been the subject of a great deal of research, studies comparing~     cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect~     small to moderate differences. Therefore, the primary purpose of the present study is to~     investigate if the combination of cognitive techniques with exposure in vivo is superior to~     the effects of exposure alone for patients with moderate to severe agoraphobia.~   "
144174|NCT01680224|"~     Obesity is a major US public health problem. Few obesity prevention programs have reduced~     risk for weight gain over follow-up and those that have are very intensive, making~     dissemination difficult and costly. A brief 3-hr selective prevention program (Healthy~     Weight) targeting young adults with body dissatisfaction involving participant-driven healthy~     dietary and physical activity lifestyle changes significantly reduced increases in body mass~     index (BMI) and obesity onset relative to alternative interventions and assessment-only~     controls through 3-yr follow-up, though effects were small in magnitude. To enhance efficacy,~     the investigators added dissonance-inducing activities regarding unhealthy dietary and~     activity practices, drawing from a highly efficacious dissonance-based eating disorder~     prevention program. A pilot trial found that this new Project Health intervention~     significantly reduced increases in BMI relative to both the Healthy Weight intervention and~     an educational brochure condition from pre to post. The investigators propose to conduct a~     rigorous multisite effectiveness trial that will test whether adding the dissonance-induction~     elements to the originally Healthy Weight intervention improves weight gain prevention~     effects. 360 college students at risk for future weight by virtue of their age and weight~     concerns will be randomized one of three conditions: (1) a refined 6-hr group-based~     dissonance-based Project Health, (2) a 6-hr group-based Healthy Weight intervention, or (3) a~     psychoeducational video (Weight of the World) condition. Participants will complete~     assessments of % body fat, mediators (including objectively measured physical activity),~     moderators, and other outcomes at pre, post, and 6, 12, and 24 month follow-ups.~   "
144175|NCT01680211|"~     Objective of this study is to determine the safety and efficacy of administration of herbal~     supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks~     in the management of prediabetes and mild to moderate hyperlipidemia.~   "
144176|NCT01680198|"~     The primary aim of this study was to test the hypothesis that Paricalcitol, an active form of~     vitamin D, improved endothelial function in stage 3-4 chronic kidney disease (CKD) patients.~     A secondary aim of this trial was to study the relationship between endothelial function and~     plasma/serum and genetic biomarkers of bone mineral disorders in CKD (BMD-CKD) and renin~     angiotensin-aldosteron system (RAS) (angiotensin II and plasma renin activity).~   "
144177|NCT01680185|"~     The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment~     with short acting insulin, applied continuously through an insulin pump, (i) improves~     glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers~     further β-cell protection, in comparison to the standard of care control group, and the basal~     insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented~     insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic~     events. Patients in the SAPT-NODAT study will be followed through 24 months~     post-transplantation.~   "
144178|NCT01680172|"~     Depression is common in patients with cancer. Current medications for depression, while~     effective, take several weeks to take effect. Ketamine has emerged as a drug with promise for~     cancer patients. In two reported cases, a single dose of ketamine induced rapid and~     moderately sustained symptom reduction in depression and anxiety with no adverse side~     effects. Benefit was seen in as little as 1 hour and sustained up to 30 days. This study is a~     randomized, double-blind, placebo-controlled investigation testing whether a single dose of~     ketamine improves depression and anxiety relative to placebo in patients with cancer.~   "
144179|NCT01680159|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650~     at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the~     treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but~     decreased thereafter.~   "
144180|NCT01680146|"~     Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a~     major impact on our healthcare system due to increased morbidity and greater need for~     hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to~     improve dietary intake of the elderly. It has already been shown that ingestion of dietary~     protein stimulates muscle protein synthesis and inhibits muscle protein breakdown, resulting~     in an overall positive net protein balance. However, the impact of fat (as part of the meal)~     on dietary protein-induced muscle protein synthesis remains largely unknown. Based on~     previous studies by other research groups, we hypothesize that fat further stimulates the~     muscle anabolic response to protein ingestion.~      Objective: The primary objective of this study is to investigate the effect of a single~     meal-like amount of protein with or without fat on postprandial muscle protein synthesis~     rates in healthy elderly men. Furthermore, as a secondary objective, we will assess digestion~     and absorption kinetics.~      Study design: double-blind randomized intervention study Study population: 24 healthy elderly~     men (55-85 y) Intervention: one group (n=12) will consume a test beverage of 350 mL~     containing 20 g of intrinsically labeled casein, and the other group (n=12) will consume a~     beverage of the same volume containing 20 g of casein plus 20 g of fat.~      Main study parameters/endpoints: Primary endpoint: muscle protein synthesis rates. Secondary~     endpoint: digestion and absorption kinetics.~   "
144181|NCT01680133|"~     Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent~     excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could~     play an important role in the development and exacerbating of insulin resistance. Therefore,~     the investigators propose to study the regulation of adipose tissue and skeletal muscle~     lipolysis, as well as further characterize the intracellular lipolytic pathways within these~     tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.~   "
144655|NCT01673945|"~     The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in~     the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent~     organs, with the aim of establishing for which lesions and from which location the capability~     of the FV-EUS will be superior, equal or, inferior to the CLA-EUS~   "
144182|NCT01680120|"~     Fixation of fractured neck of femur is a common Orthopedic surgery. Anaesthesia can be~     challenging in some cases like in haemodynamical unstable patients.~      The investigators have evidence of minimum effective local anaesthetic dose (MLAD) in hip~     replacement surgery but MLAD to achieve surgical anaesthesia for operative fixation of FNF is~     still unknown.~      A step-up/step-down methodology was used successfully in regional anaesthesia and also in~     other areas of anaesthesia.~      In pregnant ladies in whom spinal anaesthesia is performed on the side, significant~     correlation exist between the vertebral length measured from cervical 7 to the iliac creast~     and MLAD.~      The investigators aim it was to determine the MLAD of hyperbaric 0.5% bupivacaine required~     for Continuous spinal anaesthesia for the operative fixation of FNF.~   "
144183|NCT01680107|"~     The purpose of this study is to determine whether d-cycloserine augments the clinical effects~     of exposure-based cognitive-behaviour therapy for panic disorder.~   "
144184|NCT01680094|"~     The purpose of this study is to assess the safety and ability of panobinostat to re-activate~     HIV transcription in latently infected CD4+ T-cells among HIV-infected patients on stable~     antiretroviral therapy~   "
144185|NCT01680081|"~     This study was designed as a prospective multicenter trial to determine the accuracy of~     combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic~     perfusion imaging in patients with suspicious coronary artery disease compared conventional~     coronary angiography and quantitative dynamic perfusion MRI as standard reference.~   "
144186|NCT01680068|"~     Macular hole is a hole formation which takes place in the center of the retina. Such a hole~     needs surgical steps in order to close. Closure of the macular hole will lead to a~     substantially improvement of vision in most cases. Following macular hole surgery a tamponade~     of intraocular gas is normally injected in order to keep the macula dry for the postoperative~     period. Postoperative face down position for a week was earlier standard. Several authors~     report of good closure rates with both air tamponade or lack of face down positioning. In~     this study standard pars plana vitrectomy with peeling of the internal limiting membrane~     (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down~     positioning will not be used.~   "
144187|NCT01680055|"~     This study is designed to collect bone marrow and/or peripheral blood cells and plasma, for~     the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed~     aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine~   "
144188|NCT01680042|"~     several studies have investigated healing effect of phenytoin.In this study we investigate~     healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste~     after oral biopsy.~   "
144189|NCT01680029|"~     To evaluate the performance and safety of the PBASE-system when used in the treatment of~     acute migraine episodes of moderate to severe intensity. The study will evaluate the effect~     of treatment on migraine pain and symptoms during an acute attack and also any long-term~     effect.~   "
144190|NCT01680016|"~     This study was designed to evaluate the safety and immunogenicity of two simulated~     postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese~     children and older adults.~   "
144191|NCT01680003|"~     This is a multi-center, double blind, parallel group placebo controlled randomised trial~     designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri~     (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a~     treatment period of 48 weeks~   "
144192|NCT01679990|"~     The objective of the study is to establish the safety profile of~      Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects~     comprising of 4 treatment groups:~        1. Double treatment of PLX-PAD low dose~        2. Double treatment of PLX-PAD high dose~        3. Double treatment of Placebo~        4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will~          receive the assigned treatment twice to the affected leg, within 12-weeks interval~          between each treatment.~      The study will be comprised of 5 stages:~      Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by~     additional injection after 12 weeks and with follow-up of 12 months post second injection~   "
144193|NCT01679977|"~     Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two~     different types of training.~   "
144194|NCT01679964|"~     Switching from the ritonavir-boosted protease inhibitor component to raltegravir in stable~     HIV-infected adult patients receiving combination therapy will demonstrate improved clinical~     tolerability or lipid profiles with sustained plasma virological response (<50 copies/ml).~   "
144195|NCT01679951|"~     The purpose of this dose range finding study is to assess the effectiveness, safety and~     tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients~     with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.~   "
144196|NCT01679938|"~     The overall objective is to determine the impact of comprehensive, multifaceted, child~     care-based intervention to prevent obesity among children 2 through 5 years of age. The~     specific aims are:~        1. To determine the extent to which the intervention, compared with the control condition,~          results in a smaller age-associated increase in body mass index (BMI) after a 6-month~          intervention (primary outcome) and a 1-year follow-up period among children.~        2. To determine the extent to which the intervention, compared with the control condition,~          reduces the proportion of children who are obese (BMI >95th percentile for age and sex).~        3. To determine the extent to which the intervention, compared with the control condition,~          results in:~             1. improved dietary, physical activity and television-viewing behaviors among~               children, specifically, reducing the consumption of sugar-sweetened beverages, high~               calorie/low nutrient-dense snack foods, and fast food, increasing active time, and~               reducing TV/video viewing time;~             2. improved home food and activity environment, specifically, decreasing availability~               of sugar-sweetened beverages and high calorie/low nutrient-dense snack foods, and~               increasing parental support for healthy eating and regular physical activity;~             3. improved child care center food and activity environment, specifically, increasing~               opportunities for healthy eating and physical activity, and increasing support and~               encouragement of children's behavior change by child care providers;~        4. To assess the feasibility and acceptability of the intervention among child care~          providers and families.~      METHODS. The investigators will conduct a cluster-randomized controlled trial in 16 IMSS~     child care centers in Mexico City. The investigators will randomly assign 8 child care~     centers to the intervention condition and 8 to an assessment-only control condition.~      Multifaceted intervention. The resulting intervention will involve four main components:~        1. Training of child care providers.~        2. Curriculum sessions for children.~        3. Family outreach activities.~        4. Maintenance activities. Outcome and process measurements. Age-associated BMI (child's),~          changes in child's key obesity-related behaviors, changes in the child's home food and~          activity environment, and changes in child care food and activity environment. At the~          intervention and control child care sites, changes from baseline to one year for all~          outcome variables will be measured.~   "
144293|NCT01678664|"~     Determine wether 24 months treatment with everolimus prolongs progression free survival rate~     (based on a central assessment) after embolisation ou chemoembolisation for liver metastases.~        -  H0 a 24 months progression free survival rate less than 35% is unacceptable~        -  H1 a 24 months progression free survival rate greater than 35% would show that~          everolimus treatment is beneficial, the expected 24 months progression free survival~          rate being 50%~   "
144197|NCT01679925|"~     GnRH agonists are used in the treatment of precocious puberty in order to improve adult~     height.However,the psychosocial impact of precocious puberty is often used by the clinician~     at diagnosis to justify treatment, but can not yet be properly assessed. It can not be~     considered as a rational neither for the indication to treatment, nor to assess its potential~     efficacy.~      The overall objective of this work is to improve the conditions leading to the therapeutic~     decision and the procedures for monitoring girls with idiopathic central precocious puberty.~   "
144198|NCT01679912|"~     This clinical trial aims to compare morbidity and cost associated with acute attacks of~     hereditary angioedema in patients with an intervention based on a support after a phone call~     to the call center (SOS HAE) from a group of patients does not change their practice.~   "
144199|NCT01679899|"~     This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to~     compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone~     Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.~      A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The~     active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator,~     gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.~   "
144200|NCT01679886|"~     The main objective of this study will be to compare the diagnostic performances of~     82Rubidium-PET associated to pharmacologic stress (Persantine) to 99mTc-Sestamibi-SPECT with~     CZT cameras associated to a stress test (exercise, pharmacological, mixed) for detection of~     myocardial ischemia in a population of overweighed patients on one hand, and women on the~     other hand, in a population with an intermediate prevalence of coronary artery disease (≥ 3~     cardiovascular risk factors in asymptomatic patients or prevalence of CAD ≥ 30 % using the~     DIAMOND-FORRESTER score in symptomatic patients).~   "
144201|NCT01679873|"~     Objective: The aim of this study is to assess the impact of reporting, in abstracts of~     randomized controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs)~     of the authors on General Practitioners' confidence in the abstracts' conclusions.~      Design: Randomized Controlled Trial in 3 arms. Participants: General Practitioners (GP). They~     will be recruited among residents from the Primary Care department of the Paris Descartes~     University and among a GP network who agreed to participate to research studies.~      The allocation of participants will be done by a computerized randomization list, the~     sequence will be created by an independent statistician with a ratio 1: 1: 1. Participants~     will be blind of the hypothesis and of the randomization. Allocation concealment will be~     provided because only the statistician will have access to the randomization list.~      Methods: Three interventions will be assessed corresponding to three different types of~     abstracts: 1) abstracts not reporting neither the funding sources neither COIs of authors, 2)~     abstracts reporting funding sources and 3) abstracts reporting funding sources and COIs of~     authors.~      A sample of abstracts will be selected from published randomized trials, testing superiority,~     assessing pharmacological treatment, in the field of Primary Care and General Practice and~     having a conclusion in favor of the beneficial effect of experimental treatment in terms of~     tolerance and / or efficacy. They will then be standardized and modified to obtain three~     types of abstracts: 1) with funding sources, 2) with funding sources and COIs and 3) without~     either source of funding or COIs.~      Participants will be asked to assess one abstract of their randomization arm. Outcome: The~     primary endpoint will be the GPs' confidence in conclusions. The secondary endpoints will be~     the quality perception of the study and the interpretation of the benefit of experimental~     treatment. Responses will be ranged by a 10-point numeric scale.~      Potential interests: This study takes place in the field of Primary Care. We believe that~     better understandings of impact of funding sources and conflicts of interests are necessary~     to allow more transparency in medical research and in his translation into medical practice.~      Sample size expected: 354 participants.~   "
144202|NCT01679860|"~     Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival~     (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation~     (allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative~     conditioning is used. Reduced intensity conditionings (RIC) can decrease transplant related~     toxicity and mortality. The investigators have recently proved feasibility and potential~     efficacy of a RIC regimen in relapsed PTCL patients.~      We want to investigate whether it is possible to improve the outcome of alk negative PTCL~     pts, stage II-IV at diagnosis, by intensifying the therapeutic approach.~      The intensification will be obtained by combining intensive chemotherapy, alemtuzumab~     (anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years~     (Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between~     61 and 70 years(Clinical Study B).~   "
144203|NCT01679847|"~     The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier~     penetration of the elemene.~   "
144204|NCT01679834|"~     This multicenter, observational study will assess the efficacy and the safety of Pegasys~     (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C.~     Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local~     guidelines. Data will be collected for 96 weeks.~   "
144205|NCT01679821|"~     It was proposed in this study to evaluate the prevalence of TMD signs and symptoms in State~     University of West of Parana's dental students with natural dentition, in patients with~     removable partial dentures and double complete dentures.~   "
144206|NCT01679808|"~     Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy~     in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study.~     A garden hose was compressed from one side to simulate the posterior wall of the trachea~     bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was~     increasingly compressed in eight steps. Resistance was measured at each step for airflows 1~     l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a~     computer to estimate the cross sectional area reduction and the corresponding distance~     between the bulging (posterior)and the opposite (anterior) wall (AP-distance).~      Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy.~     The tracheal obstruction was observed during forced expiration and cough, and the cross~     sectional area reduction was estimated using the results from the model study.~   "
144207|NCT01679795|"~     The aim of this study is to evaluate the vascular effects of tibolone on climateric women~     measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound~     and compare to placebo.~   "
144208|NCT01679782|"~     The purpose of this study is to determine whether nervous system alterations and motor drive~     failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we~     will look after the role of nocturnal hypoxia in these alterations.~   "
144209|NCT01679769|"~     The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and~     radiology methods in patients with chronic hepatitis B in mainland China.~   "
144210|NCT01679756|"~     The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal~     anastomosis (EA) after laparoscopic right hemicolectomy for cancer.~   "
144211|NCT01679743|"~     Background:~      - Brain metastases are cancer cells that have spread to the brain from primary cancers in~     other organs. These tumors can be removed surgically. However, researchers are trying to find~     better ways to treat brain metastases. A new drug, GRN1005, has been designed to cross into~     the brain and deliver the cancer treatment drug paclitaxel to treat tumors. Researchers want~     to see how well GRN1005 works on brain metastases from breast or lung cancer.~      Objectives:~      - To test the safety and effectiveness of GRN1005 in treating brain metastases from breast or~     lung cancer.~      Eligibility:~      - Individuals at least 18 years of age who have breast or lung cancer that has spread to the~     brain.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor tissue samples may also be collected. Imaging studies~          will also be performed.~        -  Participants who have breast cancer will be divided into two groups. Those whose cancer~          contains the HER2 protein will be treated with the drug Herceptin as well as GRN1005.~          Those without HER2 will have only GRN1005.~        -  Participants who have lung cancer will also have only GRN1005.~        -  All participants will have two doses of GRN1005, each 3 weeks apart. On the day the~          second dose of GRN1005 is given, participants will undergo surgery to remove the brain~          tumors.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~   "
144212|NCT01679730|"~     To investigate the changes of gastrointestinal microbiota in irritable bowel syndrome~     patients by hydrogen breath test and molecular-based analysis of microbiota in~     gastrointestinal tract~   "
144213|NCT01679717|"~     In this randomized controlled trial the investigators want to investigate whether early~     versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a~     faster recovery of hand function. The investigators also want to explore patients'~     satisfaction with the two different treatment regimes. The participants in the control group~     will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in~     a splint for six weeks. The participants in the intervention group will use a soft splint for~     six weeks, but will be instructed to remove the splint daily to perform exercises for the~     thumb. A total of 70 patients will be included in the study.~   "
144214|NCT01679704|"~     This study is initiated to investigate the glycemic index value of ten food products.~   "
144215|NCT01679691|"~     Epidural anesthesia is a very useful tool in lower limb salvage surgery, which helps pain~     control intra and more importantly post-operative pain. It is a well-known effect of epidural~     injections to cause a sympathetic stimulation and consequently vasodilatation in the lower~     limb vessels.~      Since epidural catheters can cause vasodilatation in lower limb vessels, they can~     subsequently lead to increased intra and post-operative bleeding from the surgical wound.~      The study will involve all patients having a bone tumor in the lower limb and subjected to~     tumor resection and reconstruction by prosthesis.~      The patient will be randomized according to the administration of epidural anesthesia into~     two arms, an arm in which epidural anesthesia was employed and another arm in which the~     patient was subjected only to general anesthesia and the amount of intra and postoperative~     bleeding will be compared in both arms.~   "
144216|NCT01679678|"~     This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety~     and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical~     control. The study will enroll adult subjects with post traumatic/post surgical, venus~     insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be~     followed for 12 weeks.~   "
144217|NCT01679665|"~     Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1~     and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good~     safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the~     candidate vaccine for the phase 3 clinical trial.~      This clinical trial is a supplementary phase 2 trial, which is designed to study the gene~     expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5~     years old use a systems biology approach combined with microarray analysis，RT-PCR and~     neutralizing antibody testing for PBMC and serum collected form the studied children~     population, to predict immunogenicity, and explore mechanistic insights about the EV71~     vaccine.~   "
144218|NCT01679652|"~     Investigators want investigate the following hypothesis:~        1. Nebivolol increases nitric oxide activity in the systemic circulation and the kidney~        2. The increased activity of nitric oxide during nebivolol treatment can be demonstrated by~          inhibition of NO synthesis with L-NMMA. We expect increased responses in blood pressure~          and sodium excretion is expected during nebivolol treatment compared to placebo.~   "
144219|NCT01679639|"~     This open-label, fixed-sequence, three-period, single group study will evaluate the effects~     of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will~     receive single doses of aleglitazar in all three periods and single doses of rifampicin in~     periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is~     up to 14 weeks.~   "
144220|NCT01679626|"~     In anesthesia, intubation is a technique used to secure an airway. This technique is not~     always straightforward. Sometimes it is difficult to place an endotracheal tube. There are~     two manners of giving pressure to the patients neck, to improve view and facilitate~     intubation.~      The investigators hypothesize that by giving this pressure the effective work area is likely~     to be smaller. The investigators would like to quantify this effect by measuring the~     effective work area, using a specially designed computer program.~   "
144221|NCT01679613|"~     The objective of the current study is to investigate the relative bioavailability of a single~     dose of nintedanib low or high dose with and without coadministration of ketoconazole at~     steady state~   "
144222|NCT01679600|"~     The propose of this study is to evaluate the feasibility and the clinical efficiency of~     feedback-controlled robotics-assisted treadmill exercise (RATE) technology for cardiovascular~     rehabilitation early after stroke. The investigators hypothesize that feedback-controlled~     RATE might be suitable and effective to improve cardiovascular fitness and functional~     carryover in non-ambulatory individuals with sub-acute stroke.~   "
144305|NCT01678508|"~     In a population-based study to explore the impact of TPMT-status on the risk of relapse and~     of second cancer among all patients treated according to the NOPHO ALL2000.~   "
144656|NCT01673932|"~     The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear~     cells (UCBMC) treatment of chronic ischemic stroke.~   "
144223|NCT01679587|"~     Primary objective was to assess in subjects with CKD: Safety and tolerability of molidustat~     (BAY 85-3934), effects of molidustat on non-invasive hemodynamics Secondary objectives were~     to assess: Effects on pharmacodynamic parameters of erythropoiesis (erythropoietin,~     reticulocytes, erythrocytes, hemoglobin, hematocrit), pharmacokinetics of molidustat,~     exploratory biomarkers, ie, midregional pro-atrial natriuretic peptide, midregional~     pro-adrenomedullin, plasma renin activity, and optionally B-type natriuretic peptide,~     vascular endothelial growth factor, cyclic guanosine monophosphate, cyclic adenosine~     monophosphate, and noradrenaline~   "
144224|NCT01679574|"~     The purpose of this study is to compare and determine the efficacy of letrozole~     administration to that of combined metformin and Clomiphene in infertile women with~     polycystic ovary syndrome (PCOS) not treated before with any ovulation induction agent~   "
144225|NCT01679561|"~     Both organ-specific and systemic autoimmunity are associated with an increased prevalence of~     recurrent miscarriage and reproductive failure, rendering the role of the maternal~     immunological system in fertility a key concept. It is believed by some that central to this~     theme is the maternal cytokine profile, with particularly T-helper (Th) cells. Immune~     modulating therapies have therefore been mooted as potential therapeutic strategies. Recent~     reports of high pregnancy rates achievable in women with RIF have added fuel to the debate~     regarding the effectiveness of intralipids in modulating the immune system.~   "
144226|NCT01679548|"~     To compare the efficacy between single-port and three-port laparoscopic assisted vaginal~     hysterectomy in patients with benign or preinvasive uterine disease~   "
144227|NCT01679535|"~     This study will determine if an education program about hygiene and child feeding practices,~     taught by local village community health workers, will improve child growth and decrease the~     prevalence of childhood malnutrition in a rural region of Kenya.~   "
144228|NCT01679522|"~     To compare the feasibility, safety, and efficacy between single-port and four-port~     laparoscopic surgical staging in patients with early stage endometrial cancer.~   "
144229|NCT01679509|"~     To compare the safety and efficacy between single-port and three-port adnexal surgery in~     patients with benign ovarian and tubal disease~   "
144230|NCT01679496|"~     The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory~     markers after intake of food items with different fatty acid composition.~   "
144231|NCT01679483|"~     To compare the incidence of lymphocele and lymphatic ascites between patient who use versus~     who do not use FloSeal during lymph node dissection~   "
144232|NCT01679470|"~     This is an open-label, single-center, single-dose efficacy pilot study of AuroLase Therapy in~     the treatment of subjects with primary and/or metastatic tumors of the lung where there is~     airway obstruction. In this study patients will be given a systemic IV infusion of particles~     and a subsequent escalating dose of laser radiation delivered by optical fiber via~     bronchoscopy.~   "
144233|NCT01679457|"~     The objective of this study is to learn how to improve treatment for clients who are working~     hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but~     who are not making the progress that would typically be expected. Therefore, the~     investigators will be comparing the performance of such clients in a treatment as usual~     (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance~     and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The~     investigators hypothesize that clients will perform significantly better in the ACT-focused~     ERP session than they will in the TAU-ERP session. More specifically, the investigators~     hypothesize that clients and an independent rater will report that in the ACT-focused ERP~     session, clients performed significantly fewer rituals and/or avoidance behaviors, exerted~     significantly more effort, had significantly less difficulty getting started with the ERP,~     were significantly less influenced by their uncomfortable thoughts/feelings, were~     significantly more willing to experience discomfort, were significantly more focused on~     working towards what is important to the client. The investigators also hypothesize that an~     independent rater will rate clients as significantly more compliant with the ACT-focused ERP~     session than with the TAU-ERP session. The investigators also hypothesize that clients will~     rate the ACT-focused ERP session as significantly more preferable and acceptable than the~     TAU-ERP session, and that they will report being significantly more willing to do the~     ACT-focused ERP session again.~   "
144234|NCT01679444|"~     This protocol will investigate the neurobiological underpinnings of alcohol craving in~     recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This~     clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and~     other brain metabolites correlate to measures of alcohol craving severity~   "
144235|NCT01679431|"~     Calcific aortic stenosis (AS) has become the most common cardiac disease after coronary~     artery disease and hypertension. Unfortunately no medical therapies have been proven to~     decrease either the progression of valve stenosis or the resulting adverse effects on~     myocardial remodeling and function. In light of the studies performed in PROGRESSA, it~     becomes obvious that: i) AS is a complex and actively regulated process that involves the~     interaction of several pathways including lipid infiltration and retention, chronic~     inflammation, osteogenic activation, and active mineralization within the valvular tissues;~     ii) AS is not a disease strictly limited to the aortic valve but rather a systemic disease~     that often involves calcification and stiffening of the aorta and impairment of LV function~     as a consequence of pressure overload. Our findings suggest that the dysmetabolic milieu~     linked to visceral obesity may accelerate the deterioration of the structure and function not~     only of the aortic valve but also of the aorta and of the left ventricle. These findings open~     new avenues of research and provide strong impetus for the elaboration of prospective studies~     focusing on the valvulo-metabolic risk in AS.~      The general hypotheses are: The metabolic abnormalities linked to visceral obesity accelerate~     (1) the progression of valvular calcification and stenosis, aortic calcification and~     stiffness; (2) the progression of myocardial fibrosis and dysfunction.~      The general objectives of the study are to elucidate the mechanisms implicated in the~     pathogenesis of AS and to identify the metabolic factors that determine the progression of:~     i) aortic valve calcification and stenosis; ii) myocardial fibrosis and dysfunction; and iii)~     clinical outcomes.~      This study will contribute to identifying the key metabolic determinants of AS progression~     and will pave the way for the future development of non surgical therapies for this disease.~     The results of this study would provide strong support to the realization of randomized trial~     to test the efficacy of lifestyle modification program or new pharmacological treatment~     aiming at the reduction of visceral fat and associated metabolic abnormalities in the AS~     population. Furthermore, this study will contribute to the identification of novel blood and~     imaging biomarkers of faster disease progression, which will help to optimize risk~     stratification and timing of AVR in the AS population.~   "
144236|NCT01679418|"~     Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and~     Vomiting (PONV)~   "
144237|NCT01679405|"~     An open-label, uncontrolled, multicenter phase I/Ib trial to investigate safety and efficacy~     of BIBW 2992 added to the standard therapy of Gemcitabine/Cisplatin in chemo-naïve patients~     with advanced and/or metastatic adenocarcinoma of the biliary tract~   "
144241|NCT01679353|"~     A caudal anesthesia is one of the most commonly used technique providing intra and~     postoperative analgesia in pediatric low abdominal surgery. The practice of adding adjunct~     analgesic drugs to local anesthetics for caudal block is common. The most commonly used drugs~     are opioids, clonidine, and ketamine. However, their use has been limited by adverse effects~     in children.~      Recently, the importance of magnesium in analgesic effects has been increased. Magnesium is~     the fourth most abundant cation in the body. It has antinociceptive effects in human and~     these effects are primarily based on the regulation of calcium influx into the cell.~     Magnesium is a physiological calcium antagonist and blocks N-methyl-D-aspartate (NMDA)~     receptor and such NMDA antagonism prevents the central sensitization from nociceptive~     stimulation. Many study suggested that epidurally administered magnesium could reduce the~     postoperative pain in adults. But few studies are available about the use of magnesium in~     pediatrics.~      The investigators performed prospective randomized double-blind study to examine the~     analgesic effect of magnesium added to ropivacaine and ropivacaine alone in caudal analgesia~     on postoperative pain control in pediatric patients undergoing inguinal hernia repair.~      80 children (aged 2- 6 yr) undergoing inguinal hernia repair were included in this~     prospective, randomized, double-blinded study. After inhalation induction of general~     anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal~     saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium~     50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR. Postoperative pain~     was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS,~     0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be~     followed for the duration of hospital stay, an expected average of 3 hours.~      After discharge, rescue analgesic consumption, pain scores (Parents Postoperative Pain~     Measurement, PPPM), and adverse effects were evaluated for 48h.~      The time to first supplemental oral analgesic medication demand was defined as the time from~     the end of surgery to the first registration of a PPPM( 0 - 15) ≥ 6 by parent's observation.~     48 hours after surgery, reports of delayed side effects and demands for rescue analgesics~     from the child were gathered from parents via a telephone interview.~   "
144242|NCT01679340|"~     To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and~     III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less~     toxicity.~   "
144243|NCT01679327|"~     This study evaluates the relationship of biomarker expression and efficacy of bevacizumab~     plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the~     treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3~     expression in tumor tissue by IHC and detect those protein expression level in plasma by~     ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D~     expression level in plasma by ELISA. The aim of the study is to identify whether those~     biomarkers could predict Bevacizumab efficacy.~   "
144244|NCT01679314|"~     The study will assess the treatment of patients with Chronic Obstructive Pulmonary Disease~     (COPD) stage III and IV who will self administer the AlphaCore stimulation three times a day~     over a course of 2 months. Patients will either receive an active AlphaCore device or a Sham~     device during these two months while not knowing which device they have been provided. At the~     end of the two months, all patients will be asked to continue in the study for another 2~     months to self administer with the active AlphaCore device. Subjects will complete diaries at~     home on their breathing and quality of life and will return to the clinic monthly for~     assessment by the investigator.~   "
144245|NCT01679301|"~     The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30~     participants (to allow for 20 completers) with a prescription for nocturnal oxygen, and~     meeting all eligibility criteria. All participants will undergo a single night~     polysomnography testing in a sleep lab while they're SpO2 is monitored. The study has a~     cross-over design, in which participants will receive their oxygen prescription in two~     different modes at different times during the night. The assignment (sleep vs. continuous~     mode) to which participants will initiate the night will be randomized, and all participants~     will utilize each of the two modes during the study. The hypothesis of this study is that~     there will not be a significant difference in oxygen saturation (SpO2) for participants while~     they use the SimplyGo Portable Oxygen Concentrator, set in 'Sleep Mode', or pulsed oxygen~     flow, as compared to their SpO2 while on continuous flow oxygen during sleep during the~     course of the one night sleep study.~   "
144246|NCT01679288|"~     The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA)~     and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general~     practitioner in Primary Health Care.~   "
144247|NCT01679275|"~     Congenital heart disease with need for early surgery in newborns is associated with an~     increased incidence in global impairment in development. The causes of these late adverse~     neurologic outcomes are multifactoral and include both fixed (or patient-specific factors)~     and modifiable factors. They relate to both the mechanism of central nervous system injury~     associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is~     a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The~     importance of cerebral monitoring in neonates with congenital heart problems at risk of~     developing neurological complications is increasingly recognized. In this way the most~     vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in~     (timing of) treatment.~   "
144248|NCT01679262|"~     There are several studies that have measured various oropharyngeal airway space distances~     using radiological method. However, direct confirmation of optimal size of oropharyneal~     airways (OPAs) in individual using fiberoptic bronchoscope (FOB) is lacking as now. The~     purposes of this study were to directly determinate the proper size of OPA in individual by~     FOB via different sizes of OPA in adults under general anestheisia. Additionally, we examine~     the relationships among the size of OPA, straight length from the incisors to the tip of the~     epiglottis by laryngoscopy, patient height, and external facial measurements.~   "
144249|NCT01679249|"~     An understanding of fluid changes that occur during hemodialysis (HD) with ultrafiltration~     (UF) is essential for determining the efficacy of HD, as well as for reducing complications~     related to hypovolemia or, conversely, chronic volume overload.~   "
144250|NCT01679236|"~     A. The study follows a randomized controlled design with approximately 60 smokers with a~     history of alcohol abuse age 18-29. The study will compare a 7-week mindfulness intervention~     to a matched 7-week education intervention to evaluate intervention effect on smoking~     cessation and reduction in alcohol use. The primary hypothesis is that the mindfulness~     intervention will yield statistically significantly higher smoking abstinence than controls~     as measured by carbon monoxide breath test and Time Line Follow Back at at the end of~     treatment (2-weeks post smoking cessation attempt).~   "
144251|NCT01679223|"~     The purpose of this study is to measure the level of AlloMax™ incorporation (cellular~     infiltration, collagen production, and neovascularization) in human breast reconstruction.~     The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast~     capsule at the 3-4 month time point.~   "
144253|NCT01679197|"~     This study involves research about an investigational medicine called metreleptin. The reason~     for this study is to find out how metreleptin can improve non-alcoholic steatohepatitis or~     nonalcoholic fatty liver disease associated with lipodystrophy, a rare disorder associated~     with abnormal loss of the body's fat tissue. In this study, metreleptin is considered to be~     investigational for the treatment of lipodystrophy. Metreleptin will be given via injections~     under the skin. We plan to continue therapy for a period of one year and evaluate the change~     in liver disease by a liver biopsy. We will also follow the metabolic parameters (e.g. blood~     cholesterol, liver function, insulin resistance) and body composition characteristics (e.g.~     the pattern of fat distribution in the body).~   "
144254|NCT01679184|"~     Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to~     living kidney transplantation and randomize these individuals into a desensitization protocol~     in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment~     and up to 6 months post transplant.~      If desensitization is needed prior to transplantation in individuals with a negative~     crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with~     routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine~     levels) as well as protocol biopsy evaluations.~   "
144255|NCT01679171|"~     Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome~     (e.g. hospital survival) of an ICU stay is improving in this population but little data have~     been published on long-term outcome. Beyond survival, outcome assessment in the elderly~     requires to evaluate several aspects of health: mental status, activity of daily living,~     pain, depression, frailty… referred by geriatrician as comprehensive geriatric assessment'~     (CGA).~      The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients~     mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will~     be performed on the patients' site of living.~      This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.~   "
144256|NCT01679158|"~     The purpose of this study is to evaluate the impact of minor variations in Incisionless~     Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety,~     and weight loss in the treatment of primary obesity. It will confirm, in an open prospective~     study, the action mechanisms for the POSE endoscopic treatment technique for obesity, and~     it will help determine if they are maintained at least 6 months following the procedure.~     Durability of weight loss will be tracked through post-POSE visits up to 18 months following~     the procedure.~   "
144257|NCT01679145|"~     The aim of this project is to assess which behavioral and neuroimaging alterations associated~     with reward- based learning predict relapse in alcohol- dependent patients within a follow-~     up period of 12 months.~      The investigators will explore how these alterations interact with clinical and psychosocial~     factors which can modify the relapse risk. Functional magnetic resonance imaging (fMRI) and~     positron emission tomography (PET) will be used to identify neurofunctional abnormalities in~     neurotransmitter systems. The investigators will also provide data for genetic analysis and~     modeling.~      Patients will be detoxified in an inpatient setting and followed for 12 months using the~     Time-Line Follow- Back Procedure. Clinical assessments, behavioral paradigms of learning and~     brain imaging will be carried out within at least 4 half- lives after any psychotropic~     medication.~      The investigators will implement and apply functional imaging paradigms assessing~     Pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters~     of learning with alcohol craving, intake and prospective relapse risk.~   "
144258|NCT01679132|"~     The BAROSTIM NEO HTN trial is a prospective, randomized, controlled trial to demonstrate the~     safety and efficacy of the Barostim Neo system in subjects with resistant hypertension.~      Currently, the BAROSTIM NEO HTN trial is not actively enrolling. CVRx is conducting long-term~     follow-up of patients implanted with the BAROSTIM NEO device. This update was not done for~     any subject protection concerns that would preclude continuation of the investigation.~   "
144259|NCT01679119|"~     The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in~     combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell~     Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based~     chemotherapy.~      There is no standard of care for the treatment of this group of patients. If demonstrated to~     be efficacious and safe to deliver this regimen will be further tested in a phase III trial~     to determine whether this should become the standard of care amongst patients with DLBCL not~     fit for anthracycline (R-CHOP).~   "
144260|NCT01679106|"~     Up to 174 patients undergoing renal transplantation will be randomized to one of two groups.~     Randomization will be based on computer-generated codes using random block sizes ranging from~     4 to 8.~      Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA~      The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores~     will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic~     benefit. In addition, the presence of any pain at the incision site will be noted at the 1~     month surgical follow-up to determine any evidence of chronic pain.~      The investigators hypothesis is that unilateral kidney transplant patients with a continuous~     TAP catheter will have decreased pain scores and opioid usage compared to those receiving~     standard analgesic therapy.~   "
144261|NCT01679093|"~     The purpose of our study is to determine if there is an antagonism between drugs used in the~     prevention of postoperative nausea and vomiting (PONV) on the analgesia led by acetaminophen~     after thyroidectomy.~   "
144262|NCT01679080|"~     Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are~     fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the~     present study is to investigate the effect of treatment of adult OI patients with~     bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture~     risk and quality of life.~      The investigators will therefore conduct a double blind, placebo controlled trial, taking~     genotype and previous antiresorptive therapy into account.~   "
144319|NCT01678326|"~     The purpose of this study is to prospectively compare the efficacy of endoscopic~     ultrasound-guided biliary interventions (EUS-rendezvous or direct EUS-guided therapy) to that~     of advanced ERCP cannulation techniques in the setting of difficult cannulation. We~     hypothesize that EUS-guided interventions will be more successful and may be associated with~     the same complications as using advanced ERCP techniques in cases of difficult bile duct~     access.~   "
144263|NCT01679067|"~     To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people~     are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more~     likely to be diagnosed with opportunistic infections, their risk of death is higher and their~     rate of immunological improvement is slower (Mussini C et al., 2008). These patients often~     present a real challenge due to their advanced clinical status (Borghi V et al., 2008).~     Unfortunately, little is known about the clinical presentation of these patients, their~     responses to antiretroviral treatment and especially about the changes in the adaptive and~     innate immunity of the GALT.~   "
144264|NCT01679054|"~     This is a retrospective cost-minimization analysis study to compare the costs of treatment~     with EOF vs EOX regimens in patients with gastric cancer (GC) in Hong Kong. Patient baseline~     characteristics and cost data will be extracted from records and compared.~   "
144265|NCT01679041|"~     The purpose of this study is to evaluate the toxicity and the effectiveness of high dose~     chemotherapy with HPC transplant Multiple Sclerosis that has failed at least two lines of~     therapy~   "
144266|NCT01679028|"~     The purpose of this study is to see how safe an investigational new drug (T89) is and how~     well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.~   "
144267|NCT01679015|"~     Evaluating the percentage of patients that suffer from eye allergies and determining whether~     they also have dry eyes.~   "
144268|NCT01679002|"~     To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of~     BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to~     assess the tolerability of such regimens in healthy subjects.~   "
144269|NCT01678989|"~     Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of~     children of BD parents and diagnosed with and BD children whether or not brain has affected~     zones. These groups were compared to healthy controls and whether or not the mental health of~     children is influenced will be evaluated by the clinical investigation.~   "
144270|NCT01678976|"~     To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single~     900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a~     single 900 mg dose of BIA 2-093 and Oxcarbazepine.~   "
144271|NCT01678963|"~     The purpose of this study is to evaluate the safety and efficacy of topical ophthalmic~     squalamine lactate eye drops in treating patients with neovascular age-related macular~     degeneration (wet AMD), a degenerative retinal eye disease that causes a progressive,~     irreversible, severe loss of central vision.~   "
144272|NCT01678950|"~     Recently, an uncalibrated minimally invasive Pulse-code Modulator (PCM) has been developed:~     the MostCare system. This monitoring system is powered by Pressure Recording Analytical~     Method (PRAM), which is based on the mathematical analysis of the arterial pressure profile~     changes. It allows beat-to-beat Stroke Volume (SV) assessment from the pressure signal~     recorded invasively in radial, brachial, or femoral arteries. The most innovative features of~     this method are: 1) the lack of a calibration requirement, 2) the analysis of the arterial~     wave signal is performed at 1000 Hz, 3) a dedicated arterial catheter-transducer is~     unnecessary. MostCare is powered by PRAM (Pressure Recording Analytical Method) algorithm.~     The investigators primary end-point was to evaluate the relationship between Cardiac Output~     (CO) measured by MostCare with CO calculated with Echo-Doppler in Intensive Care Unit (ICU)~     patients under different clinical conditions. As a secondary end-point the investigators~     evaluated the relationship between CO measured by MostCare with CO obtained with~     thermodilution techniques (standard bolus thermodilution or transpulmonary thermodilution,~     i.e. PiCCO system). This is a prospective multicentre observational study.~   "
144273|NCT01678937|"~     This study is being done with the purpose of trying to understand if and why transplant~     recipients may develop tolerance to their transplanted organ. Tolerance means being able to~     lower or take away immunosuppression (anti-rejection medications) without causing organ~     rejection.~   "
144274|NCT01678924|"~     This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia~     (PHN).~   "
144275|NCT01678911|"~     This study is done to investigate the pain relieving effects of the study drug Gralise (a~     novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects with~     Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis will be~     recruited. The purpose of this research is to look at how the study drug can be used to~     benefit people who experience this type of pain. This is a phase IV study done to study the~     safety and effectiveness of the drug. At this point the drug has been approved by the Food~     and Drug Administration and has been reported to be well tolerated and effective in the~     treatment of various chronic pain conditions, particularly in neuropathic pain. About 36~     subjects will take part in this study.~   "
144276|NCT01678898|"~     This is the first human treatment with PRX-102, an enzyme being developed as a long-term~     enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha~     galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be~     evaluated in this study of increasing doses. Patients will be treated with infusions every~     two weeks for 12 weeks (7 infusions).~   "
144277|NCT01678885|"~     The primary purpose of this study is to test different methods of measuring energy balance,~     including food intake and energy expenditure. Another primary purpose of this study is to see~     if energy expenditure predicts weight and change after a weight loss diet. A secondary aim~     will be to test the reliability and validity of the Actical accelerometer, SenseWear~     Armbands, and the Intelligent Device for Energy Expenditure and Activity (IDEAA) monitors at~     measuring activity energy expenditure (AEE) and total daily energy expenditure (TEE) against~     the gold standard, doubly-labeled water (DLW). Similarly, we will test whether the estimated~     energy expenditure or posture allocation from the 3 devices is associated with weight change~     during and following a low calorie diet (LCD).~   "
144278|NCT01678872|"~     The purpose of this study is to examine the long term safety of an experimental gene transfer~     agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.~   "
144333|NCT01678144|"~     The purpose of the trial is to demonstrate the safety, performance and implantability of the~     Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial~     aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty~     rings.~   "
144279|NCT01678859|"~     Infertility affects approximately one in six couples1. In approximately one third of cases,~     there is no cause found as to why a couple are unable to conceive2. In order for natural~     pregnancy to occur, sperm must pass through the cervix (neck of the womb) and swim to the~     woman's Fallopian tubes so that fertilisation of one of the woman's eggs can occur. It is~     known that mid-cycle mucus at the cervix is essential for sperm to gain access to the uterus~     and tubes.~      There is evidence that the composition of this mucus in women may affect fertility but this~     area has not been studied well in recent years, partly because fertility treatments such as~     IVF bypass the cervix.~      Research in sheep and cows in UCD has shown interesting differences in the cervical mucus of~     fertile and infertile animals. It appears that the mucus not only helps sperm to get to the~     uterus but may also help the sperm to mature and be ready to fertilise an egg. This mucus may~     also help prevent bacteria and infection reaching the womb.~      In conjunction with colleagues in UCD, under the leadership of Professor S Carrington, the~     investigators would like to investigate some of the properties of human cervical mucus.The~     investigators propose to do this by taking samples of cervical mucus around the time of~     ovulation and also approximately one week later in fertile women and sub-fertile women. Then~     to monitor ovulation with an ultrasound scan (follicle tracking) of the woman's ovaries and~     urinary ovulation kits and take blood for oestrogen, progesterone, LH and FSH levels.~      The investigators wish to determine if there are differences between the mucus of these women~     and how it may impact on sperm function and on fertility.~   "
144280|NCT01678846|"~     The purpose of this study is to determine whether use of the Good Schools Toolkit is~     effective in reducing violence against children in primary schools.~   "
144281|NCT01678833|"~     Background:~      Although some treatments for substance abuse are considered effective for some people who are~     drug dependent, many others do not benefit as much over time. Researchers are working to find~     out what characteristics predict treatment response. They also want to determine how to~     design treatments that are more effective for a greater number of substance abusers. This~     pilot study involves providing drug addicts with cognitive behavioral therapy (CBT), a~     treatment considered to be one of the most effective in reducing substance-abuse, to identify~     ways in which the brain works that may predict and explain treatment effects. A comparison~     group will be included that receives only standard psychotherapy or talk therapy. This~     approach will enable researchers to determine what factors might be interfering with~     favorable treatment outcomes and how to refine or develop new treatments that work well for~     more people.~      Objectives:~      - To identify individual characteristics which predict and explain the effects of CBT in~     people with opiate dependence.~      Eligibility:~        -  Males between 18 and 60 years of age who are dependent on opioids (such as heroin).~        -  Participants must be willing to take buprenorphine and receive substance abuse~          counseling.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Researchers will ask questions about participants ability to cope in certain situations,~          along with questions about drug use and lifestyle issues. These questions will be asked~          twice, before and after completing treatment.~        -  Participants will be placed into one of two groups. One group will have CBT twice a week~          for 8 weeks. The other group will have standard counseling twice per week. Both groups~          will take buprenorphine as part of the drug abuse treatment.~        -  Participants will have other tests during this study. They will have imaging studies to~          look at brain function. These studies will test thinking and decision making.~   "
144282|NCT01678820|"~     The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin~     fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control~     while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks~     of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated~     with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.~   "
144283|NCT01678807|"~     The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU]~     and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust~     mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least~     one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house~     dust mite-induced allergic rhinitis/rhinoconjunctivitis.~   "
144284|NCT01678794|"~     To advance our understanding of the mechanisms of human cardiorenal syndrome with emphasis~     upon the interaction of diuretic therapy and the renal-angiotensin-aldosterone -system and~     cGMP pathway.~      The belief is that the chronic AT1 receptor blockade in subjects with compensated CHF and~     renal dysfunction will improve renal function with increased sodium excretion, glomerular~     filtration rate and effective renal plasma flow and renal function reserve as compared to the~     response of placebo-treated subjects.~   "
144285|NCT01678781|"~     A study to evaluate, by country and overall, the changes from baseline of the irritable bowel~     syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with~     Duspatalin® or Dicetel® in IBS patients.~   "
144286|NCT01678755|"~     This is an efficacy study evaluating a experimental treatment for cognitive deficits in~     adults with schizophrenia.~   "
144287|NCT01678742|"~     The aim of our study is to investigate the effects of high-protein diet on satiety and~     incretin hormones in patients with diabetes.~   "
144288|NCT01678729|"~     To determine the influence of pupil size in refractive surgery. If any influence exist.~   "
144289|NCT01678716|"~     This complex evaluation of a large-scale program uses a cluster-randomized design where 20~     geographic clusters (subdistricts) were randomized to study two sets of interventions. For~     the evaluation of behavior change interventions only, the 20 clusters were randomized to 10~     intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a~     market-based model for delivering micronutrient powders (MNP) along with behavior change~     interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior~     Change Communication (BCC)-only area and MNP+BCC areas.~   "
144290|NCT01678703|"~     This study compares the effectiveness of cervical preparation before second trimester~     abortion using laminaria versus vaginal Misoprostol.~      The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol~     is superior to mechanical preparation using laminaria.~      The investigators believe that medical preparation makes the procedure easier to perform,~     equally safe, without addition of pain or discomfort.~   "
144291|NCT01678690|"~     Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort),~     to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4)~     administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and~     safety will also be assessed during this 1-week period.~   "
144292|NCT01678677|"~     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8~     different formulations of investigational NTHI vaccine in current and former smokers, 50-70~     years of age.~   "
144669|NCT01673763|"~     The presented study is designed to analyze the efficacy of pancreatic stent insertion in~     patients undergoing ERCP with accidental cannulation of the pancreatic duct.~   "
144294|NCT01678651|"~     Different kinetics markers have been proposed to select embryos with higher implantation~     rates. The effect of external factors on these markers, such as the stimulation protocol~     should be analyzed. There are two different types of FSH that are commonly used for in vitro~     fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of each~     kind of hormone on embryo kinetcis is still unknown. The aim of this study is to observe if~     there is a difference in embryo kinetics and morphology as well as oocyte morphological~     parameters between the two types of FSH and therefore to analyze if such markers can be used~     despite of the stimulation protocols chosen.~   "
144295|NCT01678638|"~     The purpose of this study is to determine whether early (before NICU discharge) or late~     (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who~     have an inguinal hernia.~   "
144296|NCT01678625|"~     Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care~     unit when muscle relaxant drugs have been used in the operating room. The only method of~     reliably detecting the presence of neuromuscular blockade is through the use of quantitative~     neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and~     display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio~     of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this~     ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the~     endotracheal tube can be removed. At the present time, there is only one~     commercially-available quantitative monitor available in the United States -the TOF-Watch. It~     is not used by many clinicians because it requires experience to obtain accurate results, is~     expensive, and is subject to interference by factors in the operating room. The aim of this~     investigation is to examine a new quantitative monitor (the T4-EMG (EMG = electromyography)~     that may not be subject to the same limitations as the TOF-Watch AMG (AMG =~     acceleromyography). In order to study the accuracy of this new device, the T4-EMG will be~     compared to the current clinical gold standard, the TOF-Watch.~   "
144297|NCT01678612|"~     Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality.~     Commonly touched items in the patient care environment harbor microorganisms that may~     contribute to HAI risk. The purpose of this study is to assess whether placement of~     copper-alloy surfaced objects in a pediatric intensive care unit (PICU) reduce risk of HAI in~     comparison with non-copper surfaced objects.~   "
144298|NCT01678599|"~     The purpose of this study is to estimate the gain in sensitivity of several multiple-sample~     strategies of PCR samples with respect to the current standard (single sample of 10 ml) to~     detect Chagas chronic stage at baseline and to identify the optimal sampling strategy based~     on the sensitivity, cost,the completeness of sampling and the acceptability for study~     patients.~   "
144299|NCT01678586|"~     In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized~     clinical trial to compare the clinical effectiveness of radicular pain relief by either~     acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative~     Sensory Testing (QST).~   "
144300|NCT01678573|"~     The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations~     change over time) of abiraterone acetate after oral administration of abiraterone acetate at~     different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under~     fasted conditions.~   "
144301|NCT01678560|"~     Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to~     the patient in terms of serious co-morbidities and results in a great cost to the VA Health~     Care System to treat the co-morbidities, which include heart disease, stroke and~     neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and~     studies have shown a poor adherence to treatment. The investigators hypothesize that using~     wireless technology will lead to early detection of problems of treatment use and will~     translate into early remedial action which will improve the use and effectiveness of~     treatment. The investigators will compare two methods. Usual care involves downloading data~     from PAP machines at designated 3-month intervals, requiring a face-to-face clinician visit.~     Wireless care involved more frequent monitoring and intervention in the event of anomalies in~     treatment use or effectiveness.~   "
144302|NCT01678547|"~     Stroke are the main causes of motor disability among adults and are expected to impose an~     increasing social and economic burden for our Country. The impact of stroke on patients is~     enormous, with negative ramifications on the persons participation in social, vocational, and~     recreational activities. It is the primary cause of long-term disability in these countries.~     At the present stage, it is well known that control of balance during upright standing~     depends upon the central integration of afferent information from vestibular, somatosensory~     (proprioceptive, tactile), and visual systems, which constitute a multilink neural network~     for the control of neck, hip, and ankle joints. More recently, it has been studied at the~     level of cerebral cortex; vestibular inputs would reach face/neck representation of primary~     somatosensory cortex and would be then integrated with visual and somatosensory inputs in~     intraparietal, posterior end of the insula and medial superior temporal cortices. Remarkably,~     balance impairment and the associated risk of falling represent one of the most prominent and~     potentially disabling features in stroke subjects. The specific aims of this project are: to~     verify whether the robotics lower limb treatment with body weight support is more effective~     than the treadmill treatment in the reduction of motor impairment in Stroke patients, and to~     improve the quality of the gait and the endurance and to analyze possible improvements in~     terms of physiological biomechanical gait through analysis of spatio-temporal parameters.~   "
144303|NCT01678534|"~     Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind,~     placebo-controlled, with sequential inclusion of patients~   "
144304|NCT01678521|"~     Inflammation plays a major role in atherosclerosis. Pentraxin 3 (PTX3) a multifunctional~     pattern-recognition protein, is expressed in many tissues/cells, including innate immunity~     cells, endothelium and atherosclerotic plaques. Its role is controversial: it may exert~     protective cardiovascular effects and/or it may be an indicator of plaque vulnerability and~     future cardiovascular risk.~      LDL-Apheresis removes apoB100-containing lipoproteins and it can prevent progression of~     coronary artery disease (CAD). LDL-Apheresis exerts non-lipidic beneficial effects on the~     procoagulatory state and on hemorheology. No data exist about the effects of LDL-Apheresis on~     plasma PTX3 levels.~   "
144306|NCT01678495|"~     It has proposed the use of ST without microbubble treatment in randomized association with~     both intravenous and intra-arterial thrombolysis, but combined treatment (rtPA + U.S.)~     associated with MB diagnostic not yet been investigated in a randomized study.~      The aim of this study is to evaluate efficacy of the combined treatment (r-rtPA+US+MB) vs the~     standard rtPA treatment in a randomized study in consecutive patients with acute ischemic~     stroke.~      We expect to demonstrate that the combined treatment (rtPA+US+MB) will be statistically~     superior to standard treatment in terms of recanalization rate.~   "
144307|NCT01678482|"~     This is a clinical research study to determine the ability of the Clear device to treat mild~     to moderate inflammatory acne, and to determine if the average person is able to use the~     device properly according to the labeling as describe in the operator manual.~      The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in~     which the subjects will be treating themselves with the Clear device, and 2 follow-up visits~     to evaluate the results. The clinical result will be assessed by the investigator for~     improvement in the acne condition. Treatment will be performed on the face of subjects~     enrolled and who meet the inclusion criteria.~   "
144308|NCT01678469|"~     Background Gestational diabetes mellitus (GDM) is defined as a defect of glucose tolerance~     with its onset or its first recognition during pregnancy and that usually disappears, at~     least temporarily, after delivery. Its prevalence generally ranges between 3 and 6%, but may~     reach 12 to 15% in high-risk populations or specific ethnic groups. GDM increases the risk of~     potentially severe maternal, fetal and neonatal complications (gestational hypertension,~     pre-eclampsia, caesarean delivery; macrosomia; shoulder dystocia). These risks are linearly~     correlated with the level of maternal hyperglycaemia. GDM is due to a failure of pancreatic~     beta cells to sustain compensatory insulin secretion for insulin resistance that is~     physiological in pregnancy but can be much more pronounced in some women, especially in case~     of overweight or obesity. Maternal obesity is a major risk factor of GDM. Yet, micronutrient~     deficiencies are frequently reported in obese patients. Some nutritional deficiencies,~     concerning particularly some lipophilic micronutrients (vitamin A, vitamin D, vitamin E,~     carotenoids) may be associated with diseases linked to insulin resistance. Numerous studies~     show an inverse relationship between plasma concentrations and/or dietary intake of these~     micronutrients and incidence of type 2 diabetes. Vitamin D deficiency could be involved in~     the pathogenesis of type 2 diabetes through an alteration of insulin secretion and~     sensitivity. Deficiencies in vitamin A, vitamin E or carotenoids (in particular lycopene and~     beta carotene) increase oxidative stress and pro-inflammatory status, and could thus be~     implied in the physiopathology of insulin resistance and glucose intolerance.~      Some case-control studies find an inverse correlation between the plasma concentrations of~     vitamin D during pregnancy and the incidence of GDM, independently of age, ethnic origin and~     of body mass index. Data are scarce for vitamin A and vitamin E, and are lacking for~     carotenoids. Besides, the few available studies are mainly descriptive ones, without clear~     explanations on underlying mechanisms. The favourable effects of these micronutrients on~     insulin sensitivity could be partially mediated by adipokines and/or pro-inflammatory~     cytokines secreted at the level of the adipose tissue. Numerous studies showed that women~     developing GDM during their pregnancy presented with a significant decrease in the~     circulating rates of adiponectin, (that is an adipokine with anti-inflammatory and~     insulin-sensitizing properties) and a significant increase in the secretion of the~     pro-inflammatory cytokines implied in the physiopathology of insulin resistance. In our~     laboratory (INRA unit 1260), we showed in experimental works conducted in vitro in human~     adipocytes and in vivo in mice that vitamin E could induce the transcription and the~     secretion of adiponectin; we also showed that vitamin D or lycopene could modulate the~     inflammatory reaction in the adipose tissue, which is involved in the physiopathology of~     insulin resistance.~      Aims and methods We hypothesise that, in pregnant women, there is a link between plasma~     concentrations and dietary intakes of lipophilic micronutrients (mainly vitamins A, D, E and~     carotenoids), secretion of adipokines and pro-inflammatory cytokines, and risk of developing~     a GDM; we also hypothesise that this relationship is independent of age, body mass index,~     ethnic origin and other main risk factors of GDM. To test this hypothesis, we aim to lead a~     transversal monocentric study, within a population of 500 pregnant women submitted to a~     systematic screening of GDM by an oral glucose tolerance test (OGTT) in the Hôpital Nord of~     Marseilles.~      The main criterion of evaluation of the link between lipophilic micronutrients and GDM will~     be a nutritional score calculated as follows: for each micronutrient (vitamin A, D, E,~     lycopene, beta carotene, alpha carotene, lutein), we will attribute 0 point if the patient is~     situated in the lowest quartile, 1 or 2 points in the following quartiles, and 3 points in~     the highest quartile. At the end, each patient will thus have a score between 0 and 21~     reflecting the global status of these micronutrients.~      The main secondary objectives will be to define the relationships between the plasma~     concentrations and dietary intakes of these micronutrients and 1/the value of glycemia and~     insulinemia during OGTT 2/the degree of insulin sensitivity estimated by the measure of HOMA~     index, 3/the circulating rates of some adipokines (mainly adiponectin, leptin, chemerin) and~     pro-inflammatory cytokines (TNF alpha, IL-1, IL-6), and 4/the children's birth weight.~   "
144309|NCT01678456|"~     Prospective registration and independent assessment of SAE associated with atrial~     fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by~     a Critical Event Committee.~   "
144310|NCT01678443|"~     This phase I trial studies the side effects and best dose of monoclonal antibody therapy~     before stem cell transplant in treating patients with relapsed or refractory lymphoid~     malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal~     antibody BC8, can find cancer cells and carry cancer-killing substances to them without~     harming normal cells. When the healthy stem cells from a donor are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets. Giving radiolabeled monoclonal antibody before a stem cell transplant may be~     an effective treatment for relapsed or refractory lymphoid malignancies.~   "
144311|NCT01678430|"~     The purpose of this study is to compare ofatumumab & chlorambucil (O-Chl) versus ofatumumab &~     bendamustine (O-B) in patients with Chronic Lymphocytic Leukaemia who are considered not fit~     enough for rituximab, fludarabine & cyclophosphamide (R-FC).~   "
144312|NCT01678417|"~     Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of~     less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has~     relatively good prognosis, continual treatment is needed due to frequent relapse. FL with~     histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma.~     Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of~     relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using~     131I-rituximab in refractory or relapsed patients with FL or MCL~   "
144313|NCT01678404|"~     Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with~     variable differentiation status, which is distributed to a variety of organs.~      A high response rate and long term survival is possible through surgery or radiation therapy~     alone in the case of limited disease. However frequent relapse and progression is observed~     despite of long term survival. The treatment after relapse has not been established yet.~      So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or~     relapsed patients with MZL.~   "
144314|NCT01678391|"~     To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone~     removal without use of fluoroscopy. Success for this study will be defined as the successful~     removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will~     only be used at the end of a presumed successful procedure to confirm that all stones are~     removed.~   "
144315|NCT01678378|"~     This community-partnered participatory study will work within high school health centers~     (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level intervention~     to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The goal of this~     study is to examine the effectiveness of the School Health Center Healthy Adolescent~     Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the SHC clinic~     environment, and the schools in which the SHCs are located. Evaluation of the intervention~     will involve random assignment of eight comparable SHCs in the Greater Bay Area of California~     that provide comprehensive health services, to either intervention or control sites.~     Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200) will be~     assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20 weeks~     follow-up to examine intervention effects on knowledge and self-efficacy regarding ARA, harm~     reduction and ARA-related resources as well as intentions to intervene with peers. For youth~     reporting recent ARA victimization, the investigators will assess for increases in ARA~     disclosure, resource utilization, as well as reduction in ARA victimization.~   "
144316|NCT01678365|"~     A prospective open randomized study conducted between July 1st 2008 and June 30th, 2009.~     Included were children younger than 14 years with Complicated appendicitis randomly assigned~     either to a single daily dose of Ceftriaxone and Metronidazole or Ampicillin, Gentamicin, and~     Metronidazole. The outcome variables compared were: maximum daily temperatures, overall~     duration of fever, time return to oral intake, length of antibiotic therapy, results of~     repeat WBC measure, general/intra abdominal complications, need for intra abdominal abscess~     drainage, Length of stay and adverse reaction.~   "
144317|NCT01678352|"~     This is a pilot study of a vaccination regime that is designed to efficiently induce~     anti-tumor T-cell responses in patients with WHO grade II glioma. The proposed regime with~     BTIC Lysate in combination with imiquimod, an FDA-approved immune response modifier will~     induce potent anti-glioma immune response with minimal or no toxicity.~   "
144318|NCT01678339|"~     Thi is an observational, non interventional, cohort analysis by using administrative~     databases (drugs treatment, laboratory and diagnostic tests, specialist visits and~     hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute~     Coronary Syndrome (ACS) event.~   "
144501|NCT01675960|"~     This study is a prospective, randomized, double blind, placebo controlled, crossover clinical~     trial looking at whether gabapentin can provide symptom relief for chronic irritability in~     neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and~     safe for children with chronic irritability that persists despite identification and~     appropriate management of symptom sources.~   "
144320|NCT01678313|"~     To investigate the therapeutic effect and safety of celecoxib adding on doxazosin and the~     potential predictive value of the absence of prostate cancer in the treatment of patients~     with LUTS/BPH and an elevated serum PSA level.~      Patients who meet all eligible requirements for entry into the study will be randomized into~     one of the two treatment groups for 3 months in 2:1 ratio as shown below:~        1. Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)~        2. Doxazosin 4mg every day (QD)~   "
144321|NCT01678300|"~     The purpose of this protocol is:~        1. To quantify the prevalence of adherence to topical mesalamine in patients with UC~        2. To describe the determinants of medication adherence in patients with UC prescribed~          topical mesalamine~   "
144322|NCT01678287|"~     This is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after~     repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy~     adult male and female subjects.~   "
144323|NCT01678274|"~     Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes~     affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence~     of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and~     autoimmune diseases in general.~      Our study aim is:~        -  Using MRI to further characterize and find risk factors leading to aortic dilation.~        -  Using MRI to assess the degree of aortic distensibility.~        -  Using Computed tomography x-ray scanning of the heart and coronary arteries to~          characterize the prevalence and degree of ischemic heart disease and coronary anomalies.~        -  Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of~          aortic stiffness when compared to controls using end points as Pulse Wave Velocity,~          Augmentation Index and Central Pulse Pressure.~   "
144324|NCT01678261|"~     The human genetic material consists of 46 chromosomes of which two are sex chromosomes. The~     sex-chromosome from the mother is the X and from the father the Y-chromosome. Hence a male~     consist of one Y and one X chromosome and a female of 2 X-chromosomes. Alterations in the~     number of sex-chromosomes and in particular the X-chromosome is fundamental to the~     development of numerous syndromes such as Turner syndrome (45,X), Klinefelter syndrome~     (47,XXY), triple X syndrome (47,XXX) and double Y syndrome (47,XYY). Despite the obvious~     association between the X-chromosome and disease only one gene has been shown to be of~     significance, namely the short stature homeobox gene (SHOX). Turner syndrome is the most well~     characterized and the typical diseases affecting the syndrome are:~        -  An Increased risk of diseases where one's own immune system reacts against one's own~          body (autoimmune diseases) and where the cause of this is not known; For example~          diabetes and hypothyroidism.~        -  Increased risk of abortion and death in uteri~        -  Underdeveloped ovaries with the inability to produce sex hormones and being infertile.~        -  Congenital malformations of the major arteries and the heart of unknown origin.~        -  Alterations in the development of the brain, especially with respect to the social and~          cognitive dimensions.~        -  Increased incidence obesity, hypertension, diabetes and osteoporosis.~      In healthy women with to normal X-chromosomes, the one of the X-chromosomes is switched off~     (silenced). The X-chromosome which is silenced varies from cell to cell. The silencing is~     controlled by a part of the X-chromosome designated XIC (X-inactivation center). The~     inactivation/silencing of the X-chromosome is initiated by a gene named Xist-gene (the X~     inactivation specific transcript).This gene encodes specific structures so called lincRNAs~     (long intervening specific transcripts) which are very similar to our genetic material (DNA)~     but which is not coding for proteins. The final result is that women are X-chromosome mosaics~     with one X-chromosome from the mother and the other X from the father. However, numerous~     genes on the X-chromosome escape this silencing process by an unknown mechanism.~     Approximately two third of the genes are silenced, 15 % avoid silencing and 20 percent are~     silenced or escape depending on the tissue of origin.~      The aforementioned long non-protein-coding parts of our genetic material (LincRNAs) are~     abundant and produced in large quantities but their wole as respect to health and disease~     need further clarification. Studies indicate that these LincRNAs interact with the protein~     coding part of our genetic material modifying which genes are translated into proteins and~     which are not. During this re-modelling there is left foot prints on the genetic material~     which can indicate if it is a modification that results in silencing or translation of the~     gene. It is possible to map these foot prints along the entire X-chromosome using molecular~     techniques like ChIP (Chromatin immunoprecipitation) and ChIP-seq (deep sequencing).~      The understanding achieved so far as to the interplay between our genetic material and~     disease has arisen from genetic syndromes which as the X-chromosome syndromes are relatively~     frequent and show clear manifestations of disease giving the researcher a possibility to~     identify genetic material linked to the disease. Turner and Klinefelter syndrome are, as the~     remaining sex chromosome syndromes, excellent human disease models and can as such help to~     elaborate on processes contributing to the development of diseases like diabetes,~     hypothyroidism, main artery dilation and ischemic heart disease.~      The purpose of the study is to:~        1. Define the changes in the non-coding part of the X-chromosome.~        2. Identify the transcriptome (non-coding part of the X-chromosome)as respect to the RNA~          generated from the X-chromosome.~        3. Identify changes in the coding and non-coding parts of the X-chromosome which are~          specific in relation to Turner syndrome and which can explain the diseases seen in~          Turner syndrome.~        4. Study tissue affected by disease in order to look for changes in the X-chromosome with~          respect to both the coding and non-coding part of the chromosome.~      6. Determine if certain genes escape X-chromosome silencing and to establish if this is~     associated with the parent of origin.~   "
144325|NCT01678248|"~     to determine the effectivness of intravitreal avastin injection on visual acuity on people~     that suffer from central retinal vein occlusion~   "
144326|NCT01678235|"~     The aim of this study is to determine whether insulin glulisine is more effective in~     postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1~     diabetes (T1DM) treated with insulin pump (CSII).~   "
144327|NCT01678222|"~     Background:~      - The immune system contains several different types of cells in the blood and other parts of~     the body. The body can fight infections well with the right balance of these cell types. The~     wrong balance of cell types may cause diseases, such as allergies or asthma. The COX-2 gene~     may help decide the balance of cell types that the body makes as part of the immune system.~     It may also play a role in certain immune system diseases. Researchers want to see how COX-2~     affects the cells in the immune system.~      Objectives:~      - To study how the COX-2 gene works in the body s immune system.~      Eligibility:~      - Individuals 18 years of age and above who are part of the Environmental Polymorphisms~     Registry.~      Design:~        -  Participants will have one study visit at the National Institutes of Health. They will~          collect a urine sample at home on the morning of the study visit.~        -  Participants will have a physical exam and medical history. They will provide a blood~          sample. They will also give researchers the urine sample they collected that morning.~        -  No treatment will be provided as part of this study.~   "
144328|NCT01678209|"~     The growing number of medications used to treat attention-deficit/hyperactivity disorder~     (ADHD) raises important questions about whether different medications have similar or~     different therapeutic mechanisms of action. We have recently shown that the stimulant~     methylphenidate (MPH) and the non-stimulant atomoxetine (ATX) produce clinical improvement~     via a common mechanism in motor cortex, and distinct actions in frontostriatal and midline~     cingulate-precuneus regions. These exciting findings offer a window into the common and~     unique neurophysiological mechanisms of response to stimulant and non-stimulant treatments.~     However, the interpretation and clinical utility of these results would be greatly enhanced~     by in-depth investigation of the impact of the two treatments on relevant neural networks,~     and analyses which evaluate whether improvement is achieved via normalization or other~     adaptive changes in brain function.~   "
144329|NCT01678196|"~     This project begins to evaluate the effectiveness of a web-based family outreach tool that is~     designed to promote treatment engagement among Veterans with posttraumatic stress disorder~     (PTSD) or alcohol use disorders (AUDs) but who have not yet engaged in mental health care.~     The National Center for PTSD has developed an on-line, Veteran-tailored, interactive web tool~     called VA - Community Reinforcement and Family Training (VA-CRAFT) that trains family members~     to effectively help their Veterans to engage in treatment for PTSD and/or AUDs. This project~     will provide preliminary information about VA-CRAFT's effectiveness.~   "
144330|NCT01678183|"~     This study is a pilot study. The investigators have designed a randomized, controlled trial~     of financial incentives in medication adherence, focusing primarily on poorly-controlled~     diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that~     many patients do not take their medications as prescribed by their doctors. This contributes~     to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and~     death. The investigators hypothesize that use of a financial incentive will motivate patients~     to improve their medication adherence and ultimately their control of their chronic diseases.~      The investigators plan to identify patients who get Primary Care at Boston Medical Center who~     still have high blood sugars more than a year after their diabetes diagnosis, and randomize~     them to a control arm, or one of two intervention arms. Subjects will be approached at the~     time of a regularly-scheduled appointment with their Primary Care doctor and offered the~     opportunity to participate in the study. All subjects who agree to participate in the study~     will meet with a Clinical Pharmacologist to review their medications in detail, and then~     undergo randomization. Subjects in the first intervention group will receive a cash incentive~     for picking up medications for the targeted conditions from the pharmacy each month. Subjects~     in the second intervention group will receive a cash incentive for picking up medications for~     the targeted conditions from the pharmacy each month, and a one-time payment at the~     conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators~     will enroll a total of 100 subjects in the study, and anticipate an observational cohort of~     approximately 1,000 patients.~      All patients who are eligible for the study but who are not enrolled in the study and have~     not declined to participate in the study will become the observational cohort for the study.~     The observational cohort will be used to determine whether randomization to the control arm~     of the study has a negative, rather than neutral, effect on patients.~      At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to~     have their blood pressure checked and to have their blood drawn so that their blood sugar and~     cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel,~     systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and~     macrovascular complications, and death.~   "
144331|NCT01678170|"~     This trial is going to evaluate the value of blood-oxygen functional imaging technology in~     the diagnosis of breast diseases.~   "
144332|NCT01678157|"~     The objective of this study is to examine the safety and efficacy of porcine acellular dermal~     matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of~     laparoscopic large paraesophageal hernia repair.~   "
144334|NCT01678131|"~     This study will evaluate the technical feasibility of using fine needle aspiration (FNA) of~     liver tissue to obtain vaniprevir (MK-7009) liver pharmacokinetic (PK) data, working towards~     identifying a minimally invasive, reproducible platform to measure liver PK. The study will~     be done in 2 parts. In Part 1, participants will be randomized to one of five FNA/core needle~     biopsy (CNB) time-point collection sequences. In Part 2, participants will be randomized to~     one of two possible doses of vaniprevir and will be assigned to one of five FNA/CNB~     time-point collection sequences; participants in Part 2 will also receive background therapy~     with pegylated interferon alpha-2b (Peg-IFN alpha-2b) and ribavirin (RBV). The primary~     hypothesis is that there is a greater than 80% posterior probability that vaniprevir~     concentrations are successfully obtained at least 60% of the time from FNA liver samples~     collected at 2 of 3 specified timepoints.~   "
144335|NCT01678118|"~     Patient navigators have been shown to assist people seeking cancer screening and other~     medical services. The purpose of this study is to see whether a patient navigator can link~     smokers to available community resources shown to help smokers quit smoking.~   "
144336|NCT01678105|"~     This is a non-randomized, phase II, open label study of dovitinib in patients with~     progressive, recurrent and/or metastatic adenoid cystic carcinoma (ACC). The primary purpose~     of this study is to assess the anti-cancer effects of dovitinib in this population in order~     to evaluate whether dovitinib is worthy of further study in patients with progressive ACC.~   "
144337|NCT01678092|"~     A phase 1 single center study in which omalizumab is dosed normally (according to the product~     insert) in subjects with atopic dermatitis.~   "
144338|NCT01678079|"~     This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka,~     Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg,~     1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one~     with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and~     the other with a micronutrient supplement powder containing encapsulated calcium at the same~     dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium~     absorption will be measured using the dual stable isotope method. For each test, the~     formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable~     isotope will be given orally and a 42Ca-labeled stable isotope dose will be given~     intravenously. Urine will be collected for 48 hours to measure calcium absorption.~   "
144339|NCT01678066|"~     Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate~     information when placed on a patient's Right or Left side.~      Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac~     output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The~     FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the~     manufacturer in pediatric and adult patients with leads placed on the left side. However,~     sometimes the surgical site and/or patient position precludes placement of the monitor leads~     on the left side. In such situations it would be useful to know whether placement of the~     monitor's leads on a patient's right side gives accurate cardiac output data. We will~     prospectively collect, and compare, simultaneous physiologic data for all enrolled children~     using two monitors, one on the patient's right side and one on the patient's left side.~   "
144340|NCT01678053|"~     Vocal process granulomas are inflammatory masses caused in part by vocal trauma that arise in~     the posterior aspect of the vocal folds and result in throat pain, difficulty swallowing,~     hoarseness, and globus sensation. Antireflux therapy treats most granulomas, but many are~     recalcitrant to this therapy or take months to years to resolve. Botulinum toxin injection~     into the thyroarytenoid muscle has been effectively employed for recalcitrant granuloma, but~     causes significant voice loss, occasional difficulty swallowing and, in our clinical~     experience, is associated with significant recurrence. The investigators propose injecting~     another muscle in the larynx called the interarytenoid muscle with botulinum toxin type A to~     maintain the benefit of injection with less loss of voice. The investigators have shown the~     effectiveness of this treatment in a small, retrospective analysis.~   "
144341|NCT01678040|"~     One of the many uses of cardiac magnetic resonance (CMR) is the assessment of right~     ventricular (RV) volumes. There are a number of congenital heart defects and acquired~     conditions in which management decisions are fundamentally based on ventricular volumes. The~     gold standard for assessment of RV volume is CMR. It has better near-field resolution than~     echo and excellent contrast between the blood pool and the myocardium. CMR is more suitable~     to the irregular geometry of the RV. The objectives of this study are (1) to assess~     ventricular volumes in the fasting state and after oral hydration in order to assess the~     effect of fluid status on ventricular volumes as measured by CMR; (2) to evaluate the effect~     of hydration on ventricular volumes compared the effect of with inter-observer and~     intra-observer variability, and; (3) to evaluate the effects of chamber volume on chamber~     deformation, including strain and peak strain rate. This study hypothesizes that (1)~     hydration status has an effect on right and left heart volumes, measured by CMR in healthy~     volunteers; (2) the effect of volume status will be a more significant contributor to~     variability in RV volumetry than that of inter-observer variability and intra-observer~     variability, and; (3) atrial and Ventricular deformation corrected for chamber size or volume~     is more accurate than when uncorrected for volume.~   "
144342|NCT01678027|"~     This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence~     of gastric cancer in subjects with family history of gastric cancer.~   "
144343|NCT01678014|"~     Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and~     young adult women. There are many methods in the treatment of AN, such as family therapy,~     cognitive behavioral therapy, psychotherapy and so on. However, almost 50% of patients are~     refractory to all current medical treatment and never fully recover and the standardized~     mortality ratio over the first 10 years is about 10%. For treatment-refractory anorexia,~     stereotactic functional neurosurgery may be the better choice. Deep brain stimulation and~     capsulotomy are the most used methods which has been proved effective in obsessive and~     compulsive disorders, depression and other psychiatric disorders. Many case reports indicate~     that deep brain stimulation or capsulotomy may be effective in the treatment of AN. As there~     are some common pathways between AN and other psychiatric disorder. The investigators have a~     hypothesis that deep brain stimulation and capsulotomy may be promising methods in the~     treatment of AN.~   "
144344|NCT01678001|"~     The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of~     the foot.~      Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.~      The current standard orthopaedic management of plantar fasciitis begins with nonsurgical~     treatment modalities. Surgical treatment of plantar fasciitis is indicated only if~     nonsurgical means fail.~      A newer method of treating plantar fasciitis before resorting to surgery is the use of~     Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis~     with Xeomin is important, as there are limited studies on the subject to date. The purpose of~     this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in~     one physician's (J.A.) practice at Rothman Institute Orthopaedics through a~     placebo-controlled, randomized, double-blinded study.~   "
144345|NCT01677988|"~     This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research~     study is to determine the safety and effectiveness of modified Folfirinox and radiation~     therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening~     tests will be done to determine if subjects are eligible for participation in this study. If~     subjects are eligible to participate and agree to participate they will begin chemotherapy.~     After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of~     completing radiation therapy, subjects will have surgery. There will also be post-treatment~     and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after~     their initial registration.~   "
144346|NCT01677975|"~     The goal with this study is to evaluate the value of dynamic lymphscintigraphy and~     ultrasoundscanning preoperative in patients with melanomas.~   "
144347|NCT01677962|"~     The main purpose of this study is to examine the safety of the study drug in patients with~     locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know~     about any side effects a patient may have when given the study drug. Another goal of the~     study is to determine if combining dendritic cells and the study drug can be possibly used as~     a vaccine for this disease. Dendritic cells are cells that are present in the body's immune~     system that help your body fight disease.~   "
144348|NCT01677949|"~     Study Design:~      This is a two-stage Phase II trial investigating the efficacy of Clofarabine,~     Cyclophosphamide and Etoposide in acute leukemia patients with detectable minimal residual~     disease (MRD) prior to allo-HCT. The primary objective is to determine the impact of the~     study treatment in eliminating the presence of minimal residual disease without causing a~     significant delay of allo-HCT due to treatment related toxicity. The intent of this study is~     to allow patients to proceed to transplant (independent of this study) within 42 days of Day~     1 of Clofarabine based therapy.~   "
144349|NCT01677936|"~     The objective of this study is to compare the effects of Raisins three times per day versus~     alternative snacks three times per day on blood sugar control and cardiovascular risk factors~     (weight, waist circumference, blood pressure, cholesterol levels) in patients with Type 2~     Diabetes Mellitus. These effects will be studied over a 12 week period.~   "
144350|NCT01677923|"~     The investigators hypothesize that Metformin decreases weight, normalizes lipid profile and~     increases insulin sensitivity; the study team hope to get better effect of weight decrease~     and metabolic processes repair in the intensive treatment group with intervention of physical~     activity, diet correction and Metformin use.~   "
144351|NCT01677910|"~     The primary objective of the study is to confirm that at least 1 or more doses of telotristat~     etiprate compared to placebo is effective in reducing the number of daily bowel movements~     (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the~     trial in patients not adequately controlled by current SSA therapy.~   "
144352|NCT01677897|"~     The purpose of this study is to assess the impact of the addition of metformin to abiraterone~     on survival in patients with metastatic prostate cancer~   "
144353|NCT01677884|"~     The purpose of the study is to assessed the efficiency of treatment based on the objective~     response rate (RECIST 1.1)~   "
144354|NCT01677871|"~     During the Study:~        -  Subject is required to visit every week for the first 2 months and then every month till~          completion of study or as and when required~        -  The usual symptomatic and supportive treatment of Chronic Liver Disease, including use~          of antiviral, will be given to all patients.~        -  Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular~          Treatment.~        -  Liver function tests (LFT) will be done weekly during first 2 months then at one month~          interval or as when required.~        -  The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of~          clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9.~          Patients not improving at 4 weeks after initiation of treatment will be shifted to~          alternative regimens and will be excluded from the study.~   "
144355|NCT01677858|"~     The study had the following primary objectives:~        -  Phase 1: to determine the maximum tolerated dose (MTD) of once-weekly (QW) carfilzomib~          and dexamethasone for patients with relapsed or refractory multiple myeloma who have~          received 1 to 3 prior therapies~        -  Phase 2: to estimate the overall response rate (ORR) for patients with relapsed or~          refractory multiple myeloma who received 1 to 3 prior therapies treated with carfilzomib~          and dexamethasone QW at the MTD established in phase 1.~   "
144356|NCT01677845|"~     The aim of this study is to determine the maximum tolerated dose of hypo-fractionated~     radiation therapy and the toxicity of the treatment program.~      Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this~     phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT).~     Dose escalation will be as follows:~      There will be 3 cohorts consisting of 3 patients each.~   "
144377|NCT01677572|"~     The primary objective of this study is to evaluate the safety and tolerability of multiple~     doses of Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) in participants with~     prodromal or mild Alzheimer's Disease (AD). The secondary objectives of this study are to~     assess the effect on cerebral amyloid plaque content as measured by florbetapir-fluorine-18~     (18F-AV-45F-AV-45) positron emission tomography (PET) imaging, to assess the multiple dose~     serum concentrations of Aducanumab and to evaluate the immunogenicity of Aducanumab after~     multiple dose administration in this population.~   "
144357|NCT01677832|"~     Children and adolescents with ADHD are impulsive and have difficulties in regulating their~     behaviors. It has been suggested that a core deficit in inhibitory control may account for~     dysfunctional behaviors associated with this disorder. Previous research has shown that~     medication and the self-regulation strategy of making implementation intentions (i.e.,~     if-then plans) are effective in enhancing children's inhibitory control, which is reflected~     in the behavioral as well as electrophysiological (e.g., Electroencephalogram; EEG) data on a~     Go/NoGo task in children with ADHD. As suggested by earlier research, however, forming~     implementation intentions may have different effects on people who are embedded in different~     cultures.~      The aim of the present study is to compare the effects of medication and the self-regulation~     of forming implementation intentions by assessing the behavioral performance and~     corresponding brain activity during a Go/NoGo task in children and adolescents with and~     without ADHD under two different cultural contexts. Further, this study also aims at~     investigating the potential moderating effects of culture on making if-then plans. More~     important, as we know, this will be the first study to compare the effectiveness of forming~     implementation intentions on children and adolescents with ADHD in a cross-cultural way,~     which is meaningful for researchers to explore the degree of its application and expected to~     provide clinical psychologists an alternative perspective for ADHD treatment in the near~     future.~   "
144358|NCT01677819|"~     The objectives of this study are to investigate:~        1. the effect of methylphenidate on attention;~        2. the relations between methylphenidate and inhibition control and working memory;~        3. the relations between inhibition control and verbal attention and working memory;~        4. the effect of methylphenidate on the changes of neuropsychological functioning and blood~          pressure.~   "
144359|NCT01677806|"~     Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom~     medical management has not been successful or for those who are at risk for developing~     complications due to long-term immobilization. Recently, three randomized controlled trials~     (RCT) concerning PVP have been published with conflicting results. Two RCTs with a sham~     control intervention failed to show an advantage of vertebroplasty over placebo for~     participants with acute, subacute, and chronic fractures or severe pain. In the third RCT,~     PVP compared to optimal conservative treatment showed significant immediate postoperative~     pain relief in the vertebroplasty group, but not at 3 and 12 months. To examine these issues,~     this study is initiated to compare PVP with conservative therapy in patients with~     osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP~     increases the incidence of new compression fractures in adjacent vertebrae.~   "
144360|NCT01677793|"~     Magnetic resonance imaging (MRI) is a premier modality to investigate structures and~     functions of human brain. In studies of children and adolescents, noninvasiveness of MRI~     makes it especially applicable. Developmental trajectory of gray matter volume and cortical~     thickness has been well studied in western countries. However, significant variability of~     brain structure has been reported between Chinese and Caucasian, and the variation may also~     exist in developmental trajectory of the brain. However, the maturation processes of neural~     fiber tracts in white matter are less understood. Diffusion tensor imaging (DTI), which has~     been frequently used to investigate the integrity of fibertracts in the literature, is~     limited in dealing with crossing fibers. Diffusion spectrum imaging (DSI) is a newly~     developed technique to improve the resolution of crossing fibers, and it is more suitable for~     detailed tractography assessment. In addition to establishing the template of brain structure~     (T1 and T2) and structural connectivity of our child, adolescent, and young adult population,~     the study has the following three aims.~        1. To describe gender effect and developmental change of brain volume of different cortical~          and subcortical regions, thickness of cortex brain, and structural connectivity (e.g.,~          frono-striatal, fronto-pareital, fronto-temporal and fronto-cerebeller tracts and~          superior longitudinal fasciculus II) across childhood through adolescent to adulthood;~        2. To examine the gender effects and developmental change of attention, executive function~          and visual memory from childhood to adulthood and whether gender moderates these~          developmental changes; and~        3. To correlate the structural connectivity and brain size and neuropsychological function~          within the same subjects.~   "
144361|NCT01677780|"~     This open-label, extension study is designed to provide continuing treatment with RO5045337~     to participants who have completed parent studies NO21279 (NCT00623870), NO21280~     (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).~     Participants are eligible to participate in this study if they have completed required Phase~     1 study assessments for primary objectives of respective parent protocol and are having~     evidence of clinical benefit (as defined by the parent protocol). Participants will continue~     the most similar dose and formulation available (which does not exceed the maximum tolerated~     dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and~     the same schedule of RO5045337 treatment that they were receiving at the time of~     transitioning from the parent clinical study protocol.~   "
144362|NCT01677767|"~     This observational study will evaluate the use in clinical practice and efficacy of Mircera~     (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis~     receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be~     followed for 24 weeks.~   "
144363|NCT01677754|"~     This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled~     study will evaluate the efficacy and safety of RO4602522 in participants with moderate~     severity Alzheimer's disease. Participants who are taking background therapy of~     acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4~     months before screening will be randomized to receive either one of two doses of RO4602522 or~     placebo for 12 months.~   "
144378|NCT01677559|"~     This phase I trial studies the side effects and the best dose of MLN8237 (alisertib) when~     given together with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)~     in treating patients with solid malignancies that are metastatic or cannot be removed by~     surgery. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as nab-paclitaxel work by killing the cells~     or by stopping them from dividing. Giving alisertib together with nab-paclitaxel may provide~     a more effective anticancer treatment with fewer side effects.~   "
144364|NCT01677741|"~     This is a 2-part, study to determine the safety, tolerability and pharmacokinetics of oral~     dabrafenib in children and adolescent subjects with advanced BRAF V600 mutation-positive~     solid tumors. Part 1 (dose escalation study) will identify the recommended Part 2~     (tumor-specific expansion study) dose and regimen using a dose-escalation procedure.~     Approximately 6 to 18 subjects will participate in Part 1 and will receive a starting dose of~     3 mg/kg and dose will deescalate or escalate between 1.5 milligram (mg)/kilogram (kg) and 6~     mg/kg. Up to 6 subjects will be enrolled at one dose level dependent upon the number of~     subjects at the current dose level, the number of subjects who have experienced a dose~     limiting toxicity (DLT) at the current dose level, and the number of subjects enrolled but~     with data pending at the current dose level. Escalation may proceed until either a maximum~     tolerated dose (MTD) is established, or until the dose in which the median pharmacokinetic~     parameters consistent with exposure in adults are achieved. Cohorts may be added in order to~     evaluate additional dose levels. Part 2 consists of four disease-specific cohorts of subjects~     with tumors known to have BRAF V600 activation (pediatric low-grade gliomas, pediatric~     high-grade gliomas, Langerhans cell histiocytosis [LCH], and other tumors such as melanoma~     and papillary thyroid carcinoma [PTC]). Each cohort will enroll at least 10 subjects with a~     pre-dose and at least 1 post-dose disease assessment. In both the parts of the study, on Day~     1, a single first dose will be administered, and repeat dosing will begin on Day 2. PK~     sampling will be performed on Day 1 and Day 15 for subjects >=25 kg in weight. For subjects~     <25 kg and >=10 kg in weight, blood samples for PK analysis will be collected on Day 1 and~     Day 15. For subjects <10kg in weight, blood samples for PK analysis will be collected after~     repeated administration on Day 15 only. Safety and tolerability will be assessed throughout~     the study. Treatment with dabrafenib will be continued until disease progression or until no~     clinical benefit or development of an unacceptable toxicity, or until they withdraw consent~     or begin a new therapy. At the end of treatment, a final study visit will occur.~   "
144365|NCT01677728|"~     The aim of this study is to explore whether target therapy in combination with chemotherapy~     as treatment could improve survival or tumor response in patients undergoing Synchronic~     Hepatectomy for Colorectal Liver Metastases.~   "
144366|NCT01677715|"~     Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on~     Immunity and Physical Intestinal Canal~   "
144367|NCT01677702|"~     The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective~     in reducing the occurrence of flu symptoms.~   "
144368|NCT01677689|"~     Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue~     cyanobacterium with patented freeze-thaw lysis and extraction method. According to the~     preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral~     ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause~     illness, paralysis and even death, especially in children and elderly people. This phase II~     study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in~     subjects with seasonal influenza.~   "
144369|NCT01677676|"~     This study has been designed to evaluate the safety and immunogenicity of two different~     formulations of FP-01.1 as well as build on the data set from the first in human study~     FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best~     formulation of the vaccine to evaluate in efficacy studies.~   "
144370|NCT01677663|"~     Autism or autism spectrum disorder (ASD) is a relatively common (0.3% in Taiwan),~     multi-factorial, genetically and clinically heterogeneous, childhood-onset neurodevelopmental~     disorder. Due to its high heritability and severe long-term impairment without available~     laboratory diagnosis, effective prevention or treatment, this disastrous disease has been~     prioritized for molecular genetic studies. Recent CNVs investigation to identify rare~     variants and GWA study with endophenotype approaches are promising strategies to identify~     common genetic variants. In addition to intermediate phenotypes such as head circumstance,~     speech delay, social impairments and stereotyped behaviors, evidence has demonstrated that~     neuropsychology and neuroimages may be useful endophenotypes for autism. Dlgap2, Fbxo25, and~     Arhgef10 knoutout mice generated from our previous CNV results will be characterized.~   "
144371|NCT01677650|"~     The overall objective is to develop a patient oriented research program to efficiently~     evaluate the effects of pharmacogenetic variants on the dose-response relationships and~     safety of opioids and non-opioid analgesics. If an opioid regimen can be created that~     produces excellent opioid analgesia with minimal toxicity related to supratherapeutic opioid~     concentrations (i.e., ventilatory depression), other non-opioid analgesics (i.e.,~     gabapentin/pregabalin, ketamine, lidocaine, cyclooxygenase inhibitors, etc.) that may~     decrease preoperative opioid requirements can be more efficiently and safely evaluated. These~     interventions may limit the opioid related toxicities related to effect site concentrations~     that are below those required when opioids are the predominant analgesic, such as opioid~     related ileus. Methadone's slow elimination clearance and limited pharmacokinetic drug-drug~     interactions make it an attractive perioperative opioid. The first step towards personalized~     opioid analgesia is to determine the effect of common pharmacogenetic variants that affect~     either methadone metabolism (CYP2B6) or opioid elimination.~   "
144372|NCT01677637|"~     Osteoporosis is the most common disease of bone and characterized firstly by low bone mass~     and secondly, impaired bone microarchitecture structure resulting in reduced strength and~     increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal~     Osteoporosis Osteoporosis & elderly and senile osteoporosis) and secondary. The most common~     form is postmenopausal osteoporosis. It occurs in women after menopause and is associated~     with decreased estrogen production, which normally occurs at this age women Osteoporosis~     usually occurs after age 50, it is very common in women than in men, and its frequency~     increases with advancing age.~   "
144373|NCT01677624|"~     To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in~     Japanese subjects with hypervascular tumor or arteriovenous malformation~   "
144374|NCT01677611|"~     Animal studies indicate that resveratrol, a phytoalexin enriched in the skin of red grapes~     and a constituent of red wine, is associated with longevity likely through the increased~     production of a protein, SIRT1.~      The trial is a proof-of-concept study primarily designed to examine for the first time in~     humans, the effect of 12 weeks of oral resveratrol on skeletal muscle SIRT1 expression in 10~     patients with T2DM in a randomized, placebo-controlled, double-blind fashion. Secondary~     outcomes include measures of AMPK, p-AMPK and GLUT4 expression levels, energy expenditure,~     physical activity levels, distribution of abdominal adipose tissue and skeletal muscle fiber~     type composition, body weight, HbA1c, plasma lipid subfraction, adiponectin levels and~     insulin sensitivity.~   "
144375|NCT01677598|"~     The purpose of this study is to determine how patients use ustekinumab (label-recommended or~     other/missed dose interval) in Asia-Pacific countries.~   "
144376|NCT01677585|"~     The purpose of this study is to compile real-world clinical outcomes data for the PROMUS~     Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element~     and PROMUS Element Plus Stent System) in routine clinical practice in China.~   "
144379|NCT01677546|"~     Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models.~     Together with wireless communication with blood glucose meter potentially facilitates~     achieving the target post prandial glucose levels. In this RCT authors assessed whether use~     of wireless communication between compatible devices: MiniMed insulin pump and blood glucose~     meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is~     the impact of exerting this tool on metabolic control in type 1 diabetic patients.~   "
144380|NCT01677533|"~     The PROVE aims to test the efficacy of panel management support and educational intervention~     in VA Primary Care Clinical Microsystems. The study will test three increasingly intensive~     methods for implementing panel management strategies among health care providers in VA~     primary care clinics: providing only panel data, providing panel management support, and~     providing support plus clinical microsystem-enhancing education and training.It is~     hypothesized that the group receiving panel management and educational interventions will~     have better smoking cessation and hypertension outcomes than the group receiving only panel~     management assistance. It is further supposed that the later will have better smoking~     cessation and hypertension patient outcomes than the data-only group.~   "
144381|NCT01677520|"~     The overall purpose of this study is to enhance identification and isolation of ADSCs and~     adipocytes, to find the optimum culturing conditions to increase growth and volume of grafts,~     and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections are used~     in aesthetic surgery but tend to disassemble over time. If the investigators can enhance~     growth and volume of fat in culture, the investigators could use fat grafts in reconstruction~     of cancer and traumatic injury defects with the patients own cultured fat cells and grafts.~   "
144382|NCT01677507|"~     Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to~     medications is a critical barrier for the clinician to consistently provide highly effective~     IOP-based treatments. Current trial-and error approaches to glaucoma management are~     inefficient and have not addressed this barrier as there are no predictive factors for drug~     response. Our long-term goal is to improve outcomes by identifying biomarkers and~     environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of~     disease progression, poor response to treatment, and large IOP fluctuation. Our purpose of~     this research project is to address this critical barrier by focusing on physiological~     factors that predict IOP response to drugs.~   "
144383|NCT01677494|"~     Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement~     imaging), biology (markers of collagen turn-over) and proteomics~   "
144384|NCT01677481|"~     The study compares radiation exposure parameters between coronary angiography procedures~     performed by left wrist, right wrist or groin (femoral) procedure access site~   "
144385|NCT01677468|"~     The aim of this study was to evaluate whether survival of patients who underwent TACE with~     unresectable HCC can benefit from intermediate-levels of embolization.~   "
144386|NCT01677455|"~     The purpose of this study is to determine if ganetespib (STA-9090) is effective in the~     treatment of patients with HER2+ or triple negative breast cancer who have not received prior~     systemic treatment in the metastatic setting.~   "
144387|NCT01677442|"~     The purpose of this study is to compare results of general Video-assisted Thoracic Surgery~     (VATS) operations under no-intubated thoracic epidural anesthesia (NTEA) versus those of a~     control group operated under general anesthesia with double-lumen endotracheal intubation.~   "
144388|NCT01677429|"~     Hypotheses~      The investigators hypothesize that among individuals who suffer from panic disorder there is~     higher incidence of co-morbid balance impairment than in the healthy population.~      The investigators hypothesize that the treatment of panic disorder, through the treatment of~     co-morbid balance impairment using virtual reality (VR) exposure therapy environment, is more~     effective than the exposure to still pictures from the same scene in VR without balance~     challenge or comparing to standard cognitive behavioral therapy (CBT) for the treatment of~     panic disorder.~      Rationale~      This research relies on previous studies, which have shown mutuality between anxiety and~     balance impairment, even if only sub-clinical. The VR-based training environment enables~     multi-sensorial stimulus in a dynamic interactively changing setting. With the addition of a~     cognitive task (dual task distracting the fear), the investigators can add cognitive load and~     therefore challenge the control of balance even more. Individuals who suffer from balance~     impairment avoid their exposure to many balance-challenging situations - a fact that may~     increase their anxiety. The investigators assume that a considerable number of PD individuals~     also experience balance control impairments - mostly subclinical ones. Moreover, balance~     impairment accompanies other psychiatric disorders, though not enough literature exists on~     the subject.~   "
144389|NCT01677416|"~     Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of~     patients with rheumatoid arthritis (RA) and normal controls, determine the association~     between ultrasound and global disease activity, function and goniometric measures in patients~     with RA and determine the correlation between ultrasound and radiography in the detection of~     bone erosion.~      Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform,~     calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal [MTP] joints) of 50~     healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated~     bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power~     Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.~   "
144390|NCT01677403|"~     This is a study to evaluate the efficacy,indications,adverse reactions and resistance of~     combined administration of nebulized tobramycin compared with systemic administration alone~     in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.~   "
144391|NCT01677390|"~     This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of~     SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell~     carcinoma.~   "
144392|NCT01677377|"~     Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages~     of risperidone with clinically stable schizophrenia~   "
144562|NCT01675167|"~     The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is~     effective in treating opioid-experienced subjects, with moderate to severe chronic low back~     pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period~     of time.~   "
144393|NCT01677364|"~     Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were~     randomised into elective induction and spontaneous labour groups only after bishop score was~     equal to or more than 6.It was concluded that induction of labour with oxytocin is a~     relatively safe procedure in women with low risk heart disease with NYHA class I and II. It~     resulted in a similar caesarean delivery rate and was not associated with more maternal and~     neonatal complications.~   "
144394|NCT01677351|"~     Clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant~     therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular~     and blood pressure and arrhythmias.The objective of this study is evaluating the analgesic~     effect of clonidine and its repercussion on arterial and intraocular pressure and arrhythmias~     for cataract surgery.~   "
144395|NCT01677338|"~     This study is a multi-center, open-label comparison study and aimed to evaluate the~     preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying~     abnormal (delayed) gastric emptying rates in subjects.~   "
144396|NCT01677325|"~     To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a~     Chinese herb formula.~   "
144397|NCT01677312|"~     This study compares the 19G and 25G needles for procuring tissue samples from the pancreas~     during Endoscopic Ultrasound (EUS) procedures.~   "
144398|NCT01677299|"~     This study will evaluate how EFB0027 and EFB0026 behave in subjects with type 2 diabetes~     mellitus.~      In addition, this study will compare the effects of EFB0027 and EFB0026 on circulating~     concentrations of glucose and gastrointestinal hormones in subjects with type 2 diabetes~     mellitus.~   "
144399|NCT01677286|"~     The tetracycline antibiotic doxycycline disrupts A beta amyloid fibrils (AB) in Alzheimer's~     disease, transthyretin (ATTR) amyloid fibrils in familial amyloidotic polyneuropathy, and~     immunoglobulin light chain (AL) amyloid fibrils in transgenic mouse models of disease. If~     untreated, amyloid deposits impair organ function, affecting the morbidity and mortality of~     patients.~      This single-center, twelve-month, open-label, prospective, pilot phase II study aims to~     determine whether doxycycline reduces amyloid deposits and improves organ function in~     patients with systemic or localized amyloidosis.~      The investigators plan to enroll patients with measurable amyloid disease according to~     internationally-accepted diagnostic criteria. Patients must have stable organ function at~     enrollment. Eligible subjects not receiving active treatments for amyloidosis affecting their~     kidneys, heart, aerodigestive tracts, peripheral or autonomic nervous system(s), lungs, eyes,~     skin, bladder, or breasts will undergo evaluations at baseline, 6 months, and 12 months - or~     more frequently as clinically indicated.~      Over 45 years experience indicates doxycycline is a safe, well tolerated antibiotic. The~     investigators will use standard grading systems to assess doxycycline response following~     twelve months of treatment.~   "
144400|NCT01677273|"~     The primary aim is to examine and compare the effects of hydrolyzed casein (HC), intact~     casein (IC) and intact whey protein (IWP) on diet-induced thermogenesis (DIT). Furthermore,~     to study the effects on appetite regulation assessed by subjective appetite sensations, ad~     libitum energy intake and appetite regulating hormones.~      Whey and casein differ in absorption and digestion rate, with whey being a fast protein and~     casein being a slow protein. When casein undergoes hydrolysis the absorption and digestion~     rates approaches the rates of whey. In the present study the importance of absorption rate~     and amino acid composition, in regards to energy expenditure and appetite regulation, will be~     examined. HC and IC have identical amino acid composition, but differ in absorption rate,~     whereas HC and IWP have similar absorption rates, but differ in amino acid composition. We~     hypothesize that consumption of HC will increase DIT and fat oxidation to a greater extend~     that IC. Moreover, that HC and IWP will increase satiety shortly after protein consumption,~     whereas IC will be more satiating after several hours.~      The study is a controlled, randomized, 3-arm crossover study. It consists of three visits in~     a respiratory chamber separated by at least two weeks. 26 healthy, overweight and obese (BMI~     27-35 kg/m2) young men will be enrolled and randomized to the order of the three protein~     supplements (HC, IC or IWP). At each visit protein supplements (containing either HC, IC or~     IWP) will be served as breakfast, lunch and dinner. Respiratory measures will be obtained~     over 24 hours and appetite will be assessed by visual analogue scales and appetite regulating~     hormones. Furthermore, ad libitum energy intake will be assessed.~   "
144401|NCT01677260|"~     This was a single centre, single-blind, randomized, balanced, combined single dose study~     under fasting condition and multiple doses study under fed condition with normal~     diabetic-meal, two-period, two-sequence cross-over study to to compare the bioavailability of~     metformin hydrochloride 500 mg extended release caplet (test drug) and metformin~     hydrochloride 500 mg prolonged release tablet (reference formulation).~   "
144402|NCT01677247|"~     This was a randomized, single blind, two-period, two sequence cross-over study under fasting~     condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test~     and reference formulations).~   "
144403|NCT01677234|"~     Blood pressure is typically measured with a non-invasive cuff placed on the upper arm. This~     cuff cannot take accurate measurements when the patient's arm is moving. Anesthesia for a~     cesarean delivery frequently causes the patient to shiver and their arm to shake, and~     sometimes to the extent that blood pressure cannot be measured. A cuff placed on the wrist~     may be more effective when a patient is shivering because their lower arm moves less and can~     be more easily stabilized. We will be taking simultaneous blood pressure measurements both~     just before and during cesarean deliveries in order to compare blood pressure at the upper~     arm versus the wrist.~   "
144404|NCT01677221|"~     This prospective, open-label study will be conducted in 15 healthy subjects per clinical site~     ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to 5~     lesions treated on the face, chest or back with the Acleara insert. Subjects will receive up~     to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any~     adverse events.~   "
144405|NCT01677208|"~     The purpose of this study is to determine whether Danhong injection is effective in the~     treatment of acute ischemic stroke.~   "
144652|NCT01673984|"~     The purpose of this study is to demonstrate that treatment with a 6-monthly injection of~     hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy~     injections available for treating prostate cancer. The study will also aim to answer whether~     both doctors and patients would prefer treatment with a 6-monthly injection rather than~     injections every 3 months.~   "
144406|NCT01677195|"~     The primary purpose of the study is to evaluate the effectiveness of a naturally occurring~     clay substance (ACCS100) in reducing harmful effects of aflatoxin exposure (a carcinogen) and~     fumonisin (a cancer promoter). This clay substance contains of a variety of minerals~     including calcium, sodium, potassium, and magnesium. UPSN and similar aluminosilicate~     minerals have been regularly used as dietary supplements by humans and animals, and the~     safety of this naturally occurring clay substance has been tested in clinical trials. The FDA~     treats such minerals or nutritional supplements as a drug when tested for potential of~     lessening the likelihood of disease (i.e., potential for mitigating disease).~      This study involves the use of an investigational drug called Hydrated Sodium Calcium~     Aluminosilicate (ACCS100). Investigational means that the drug has not yet been approved~     by the U.S. Food & Drug Administration (FDA) for reducing harmful effects mycotoxin exposure~     in humans.~   "
144407|NCT01677182|"~     To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated~     with Bipolar 1 Disorder.~   "
144408|NCT01677169|"~     The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH)~     and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral~     blood lymphocytes of cigarette smokers.~   "
144409|NCT01677156|"~     The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus~     CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings~     (PRESET)--was designed as an observational, post-market, real-world registry to evaluate~     patterns of care, including referrals to a cardiologist, cardiac stress testing, CT~     angiography, within the first month after Corus CAD (ASGES) testing.~   "
144410|NCT01677143|"~     Pre-emptive local anaesthetics are widely used in laparoscopic surgery, but there is no~     really consistent evidence that it is useful. Studies in the literature have shown~     contradicting results. At our hospital we are currently using pre-emptive local anaesthetics~     in the trocar areas, but as the literature does not give a clear and clinically relevant~     answer, we need to find out more. This study aims to see if pre-emptive local anaesthetics~     are useful in the setting of our day-case, laparoscopic surgery.~   "
144411|NCT01677130|"~     The Acute Respiratory Distress Syndrome (ARDS) is a clinical syndrome of progressive dyspnea~     and refractory hypoxemia caused by various reasons. Although in recent years a variety of~     supportive care measures have significant progress, but the mortality rate of patients with~     ARDS is still as high as 35-40%. Mechanical ventilation is one of the main treatments with~     ARDS, which is widely used in clinical. The rational mechanical ventilation strategy can~     improve the oxygenation of patients with ARDS and reduce lung injury. Patients with ARDS~     usually have alveolar epithelial and pulmonary capillary endothelial injury, and the lesion~     has heterogeneity. The protective mechanical ventilation strategies chosen by patients with~     ARDS in clinical practice are gradually being accepted and applied. The High-frequency~     oscillatory ventilation (HFOV) is a ventilation way with high respiratory rate and low tidal~     volume. Compared with conventional mechanical ventilation, HFOV may be able to more~     effectively improve oxygenation and reduce ventilator-associated lung injury. HFOV and~     protective ventilation strategy in ARDS is consistent with an important position in the~     treatment of ARDS, but not been widely adopted in clinical practice and is still only as a~     salvage treatment. Therefore, this study intends to use HFOV treatment with conventional~     mechanical ventilation by matching the cases in patients with ARDS. By comparing the~     influences of the patient's condition and mortality with HFOV, the clinical efficacy, safety,~     and health economics effectiveness of HFOV are further investigated and adaption time and~     parameter settings of HFOV are explored, which provide better treatment options for patients~     with ARDS and improve their prognosis.~   "
144412|NCT01677117|"~     Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate~     can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main~     cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to~     improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical~     ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been~     challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians~     have more choices in the face of hypoxemia, and with the deepening understanding of ECMO,~     ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been recognized~     by the majority of medical workers. Therefore, we assume that accurately grasping the ECMO~     indications and standardizing the implementation of treatment can significantly improve the~     prognosis, shorter hospital stays, lower hospitalization costs.~   "
144413|NCT01677104|"~     Incretins have become a successful drug target in the repertoire of medications used for the~     treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on~     the vascular system in humans, independent of their glucose lowering actions and data are~     only derived from ex vivo studies in animals. Particularly little is known about clinically~     relevant benefits of GLP-1 and its analogues on the microvascular system of individuals with~     type 2 diabetes.~      The vascular effect could be medicated by endogenous GLP-1 (9,36) amide, the breakdown~     product of GLP-1 (7,36) amide which has a low affinity for the GLP-1 receptor. The~     investigators hypothesis is that the co-administration of DPP-IV inhibitors will lack the~     beneficial effects of GLP-1 on the vascular system as GLP-1 (9,36) amide will not be produced~     by the body.~      The study aims to examine the response of GLP-1 and its analogues on small blood vessels and~     examine the effect of the addition of DPP-IV inhibition in healthy lean individuals, obese~     individuals and subjects with Type 2 diabetes.~   "
144414|NCT01677091|"~     The main objective of this study is to test the effectiveness of a rehabilitation program~     with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.~   "
144450|NCT01676623|"~     Alive & Thrive is an initiative that aims to improve infant and young child feeding practices~     and reduce childhood stunting. In Vietnam, Alive & Thrive's primary intervention is~     implemented through a social franchise linked with the government's health system. The impact~     evaluation is conducted using a cluster-randomized design in which 20 commune health centers~     (CHC) were assigned to the social franchise model, and 20 CHC were assigned to routine~     government services. Repeated cross-sectional baseline and endline surveys will be used to~     assess the public health impact of this intervention. The baseline was in 2010 and an endline~     survey in the same communities will be conducted in 2014. Mixed methods process evaluation~     will be conducted in 2011, 2012 and 2013 to study the pathways through which the program~     impact is achieved.~   "
144415|NCT01677078|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) is a non invasive technique which was~     shown to be effective in the treatment of major depression.~      The dorsolateral prefrontal cortex (DLPFC) is the anatomic target in rTMS studies and the~     standard (manual) '5-cm method' for positioning the coil over DLPFC is the reference.~     Nevertheless, it has been criticized due to poor targeting accuracies attributed to~     inter-subject variability.~      Such an inaccuracy could have any therapeutic consequences as a decrease in rTMS efficacy.~      Preliminary findings suggest that a more reproductible and accurate method, based upon a~     neuronavigation system could allow for a better efficacy. This finding has to be replicated~     with sound methodology.~      Investigator's objective is to compare efficacy on mood of coil positioning based upon a~     neuronavigation device versus coil positioning based upon the standard method.~   "
144416|NCT01677065|"~     To determine whether the bioavailability of the controlled-release test formulation is at~     least as high as that for the commercial reference drug.~   "
144417|NCT01677052|"~     The primary purpose of this registry is to obtain real world clinical use of contact force~     measurements during ablation procedures.~   "
144418|NCT01677039|"~     The study is designed to test whether or not the rate and extent of absorption of oxycodone~     from a proprietary controlled-release formulation is significantly affected by~     co-administration of alcohol compared with controlled conditions (when the formulation is~     administered with water). The primary pharmacokinetic parameters are the peak concentration~     of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area~     under the plasma concentration-time curve (AUC).~   "
144419|NCT01677026|"~     The primary objectives of the Registry are to:~        1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical~          performance to a larger number of centers in the post market phase and~        2. Collect additional evidence to support reimbursement and clinical acceptance and long~          term follow up~   "
144420|NCT01677013|"~     The study is aimed to evaluate the safety and efficiency of autologous bone marrow~     mononuclear cell transplantation in treating selective patients with type 2 Diabetes~     Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote~     β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate~     local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin~     and improve β-cells function.~   "
144421|NCT01677000|"~     Establish an international registry of over 400 patients with deep infections involving the~     bone and/or joint from≥20 centers representing all regions of the world with varied hospital~     and surgeon practice settings to ensure that registry analyses and research reflect typical~     clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare~     researchers. Using a data collection platform that minimizes entry burden, collects most~     information at the time of surgery, and uses Internet technology to minimize data entry. The~     registry will include:~        1. baseline patient attributes;~        2. surgical approach, implants and technology;~        3. hospital course;~        4. surgeon and institutional characteristics;~        5. longitudinal patient outcome,~        6. post-procedure complications and revisions,~        7. serum/tissue/drainage samples.~   "
144422|NCT01676987|"~     To evaluate the efficacy and safety of a fixed-dose, single-capsule~     budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both~     delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was~     Randomized, double-blind, multicenter, phase III, parallel clinical trial.~   "
144423|NCT01676974|"~     Objectives: Prospectively study the influence of foreign travel and associated risk factors~     on the acquisition of AMR in the endogenous microbiota of healthy individuals and the~     subsequent persistence of AMR carriage and transmission to household members of these~     carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of~     bacterial infections in the year after travel (compared to non-carriers). Explore the full~     width of AMR genes and transferable genetic elements acquired during international travel.~   "
144424|NCT01676961|"~     This phase II trial studies how well romiplostim works in increasing low platelet counts in~     patients with multiple myeloma receiving chemotherapy. Romiplostim may cause the body to make~     platelets after chemotherapy~   "
144425|NCT01676948|"~     This two-part open-label, multi-arm, non-comparative study will collect long-term safety,~     efficacy and tolerability data from patients who were responsive to canakinumab from study~     CACZ885G2301E1 (Cohort 1), and from patients who are treatment naïve to canakinumab (Cohort~     2). In addition, the effect of inactivated vaccines in an SJIA patient population will be~     assessed for the development of adequate (protective) antibody levels following immunization~     according to respective local vaccination guidelines.~      Study Part I:~      All patients will be treated with canakinumab 4 mg/kg every 4 weeks (or 2 mg/kg every 4 weeks~     for Cohort 1 patients who are receiving that dose in CACZ885G2301E1) until study end unless~     discontinuation occurs, or until they qualify for Part II of the study.~      Study Part II:~      Patients who are eligible will be randomized to receive canakinumab at a reduced dose or~     prolonged dose interval (see requirements for dose reduction/dose interval prolongation~     below).~      Patients in Cohort 1 receiving 2 mg/kg q4wk in CACZ885G2301E1 will not be randomized but will~     be part of the treatment arm canakinumab dose reduction if they are eligible.~   "
144426|NCT01676935|"~     This is a long term extension study to evaluate safety and tolerability of subjects who~     complete study M10-985 which is evaluating a new treatment for subjects with mild to moderate~     Alzheimer's disease.~   "
144427|NCT01676922|"~     This observational study will evaluate the use of Avastin (bevacizumab) and conventional~     chemotherapy in patients >/= 70 years of age with previously untreated metastatic colorectal~     cancer. Data will be collected from each patient from initiation of treatment until disease~     progression occurs (minimum follow-up 12 months).~   "
144467|NCT01676402|"~     This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety,~     tolerability, and immunogenicity of same season and sequential season vaccination schedules~     consisting of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) and licensed trivalent~     influenza vaccine (TIV) administered intradermally (ID) or intramuscularly (IM). The~     hypothesis is that evaluation of these investigational schedules will inform development of~     novel influenza vaccine strategies that may offer improved and cross-protective immunity~     against antigenically diverse influenza strains.~   "
144428|NCT01676909|"~     Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress~     Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in~     increased risk of disability, high health care spending, reduced quality of life and early~     mortality. Physical wellness is increasingly recognized as a key component of the VA's~     commitment to developing recovery-oriented and Veteran-centered mental health treatment.~     There is also growing recognition of the value of interventions that promote and improve~     patient self-management of chronic medical conditions. Building on the established efficacy~     of consumer facilitated medical illness self-management programming used in the general~     population and two recent adaptations for use with SMI adults in the public health sector~     (including the investigators' own evaluation of an intervention called Living Well), the~     investigators propose to complete a randomized controlled effectiveness trial of the Living~     Well intervention and simultaneously conduct a well specified process evaluation to optimize~     knowledge accrual regarding important factors that may improve future adoption,~     implementation and sustainability of the Living Well intervention in the VA system of care.~   "
144429|NCT01676896|"~     Asthma is the most common chronic childhood illness and disproportionately affects children~     who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with~     children who live in rural areas or have included Mexican American children in their samples.~     This study builds on the original R01NR007770 with findings that demonstrated the~     intervention could improve children's asthma self-management, asthma knowledge, metered dose~     inhaler skill, asthma severity, and parents' asthma management and access to care. In this~     competing continuation, the investigators added a third arm to the current research design~     with schools randomized into either an in-school asthma intervention, an in-school~     attention-control intervention, or an alternate intervention-delivery format of a single~     5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American,~     African-American, and White rural school-aged children (grades 2-5) who have asthma and their~     parents. In addition, the investigators propose adding a non-invasive measure of chronic~     airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma~     management on airway inflammation. Families will be followed for a full year with data~     collection at baseline and at 1-month, 4-months, and 7-months after the intervention to~     assess improvement in children's asthma morbidity, asthma severity, airway inflammation,~     family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop~     group and the School-Home group will demonstrate equivalent improvements, but greater~     improvements than the Attention-Control group in:(H1.1) their asthma severity and airway~     inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office~     visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time~     4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms~     will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the~     pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to~     the Attention-Control group.~   "
144430|NCT01676883|"~     Studies have confirmed the association between plantar callosities and severely obese~     individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for~     estimating body composition because it is easy to use, noninvasive, relatively inexpensive,~     and can be performed across a wide range of subjects.~      Our hypotheses for this study are: (1)plantar callosities influence the body composition~     measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates the~     percentage of body fat compared with air-displacement plethysmography (BodPod).~   "
144431|NCT01676870|"~     The primary objective of the study is to compare in a real-world setting the efficacy of~     traditional training (today's guideline, vigorously or moderate exercise) and amount of~     aerobic interval training (1-AIT) in reduction of risk factors constituting metabolic~     syndrome.~      The secondary objective is to compare the efficacy of traditional moderate training (today's~     guideline) and amount of aerobic interval training (1-AIT vs. 4-AIT) in improving aerobic~     capacity, cardiovascular function, skeletal muscle contractile function, skeletal muscle~     energy metabolism, left ventricle systolic and diastolic function at rest and right~     ventricular function.~      The investigators hypothesized that aerobic interval training would reverse features of the~     metabolic syndrome more than traditional training.~   "
144432|NCT01676857|"~     The purpose of this study is to identify biomarkers that can be utilized in the diagnosis of~     chronic pelvic pain syndrome in men.~   "
144433|NCT01676844|"~     There is a deficit in the number of 'age-appropriate' formulations available for the delivery~     of medicines to children. Liquid preparations are considered the 'gold standard' for~     delivering medicines to children however many of these are formulated using ingredients which~     can be toxic to children (e.g. preservatives, alcohols), particularly to neonatal babies (< 4~     weeks old) who do not possess the metabolic processes and mature organ function of older~     children or adults. Rapidly dissolving oral thin films (OTFs) dissolve quickly in the saliva,~     releasing the active ingredient(s) without the need for chewing or water, making them ideally~     suited to patients who find it difficult to swallow other oral dosage forms such as tablets~     or capsules. The aim of this study is to demonstrate that OTFs can offer a safe and effective~     alternative for oral administration of phosphate supplements to neonatal infants for the~     treatment of hypophosphataemia and osteopenia of prematurity. It is hypothesised that this~     treatment will be equal to standard therapy using an oral solution. Babies born before 32~     weeks gestational age are routinely supplemented with oral phosphate as soon as they have~     been established on oral feeds in order to prevent bone disorders such as osteopenia. Babies~     recruited to this study will be given phosphate supplementation as per NHS Greater Glasgow~     and Clyde guidelines. This single-centre cross-over study will take place in the intensive~     care and special care baby units at the Princess Royal Maternity in Glasgow. The~     investigators aim to recruit 20-30 babies and will use blood phosphate levels (obtained from~     routine sampling only) to evaluate treatment effect. Babies will be randomised to receive~     either OTFs or oral solution of potassium acid phosphate for 2 weeks followed by 2 weeks of~     the other therapy. The investigators hypothesise that OTF treatment will be equivalent to~     standard oral solution.~   "
144434|NCT01676831|"~     The objective of this study is to explore the safety and the preliminary efficacy of two~     concentrations (0.06% and 0.03%)gel that is applied to lesions of early stage (IA, IB,IIA)~     Cutaneous T Cell Lymphoma patients.~      This study is supported by grant 1R01FD004092-01A1 from the Office of Orphan Products~     Development, FDA.~   "
144435|NCT01676818|"~     This phase II trial studies how well eribulin mesylate works in treating patients with~     advanced or recurrent cervical cancer. Drugs used in chemotherapy, such as eribulin mesylate,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing~   "
144449|NCT01676636|"~     The SickKids-led research team is currently developing a prenatal micronutrient powder that~     will contain calcium, iron, and folic acid with different absorption characteristics. Once~     the powder is developed, it can be incorporated into various oral delivery vehicles. The~     overall effectiveness of a micronutrient program is highly dependent on the acceptance and~     regular consumption of supplements (i.e., adherence) by the targeted users. This is a study~     of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the~     innovative prenatal multiple micronutrient supplement: traditional tablets, oral~     disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with~     a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study~     hypothesizes that that the formulation of the delivery vehicle will impact preference,~     acceptability, and palatability.~   "
144436|NCT01676805|"~     Background:~      - Lab studies help researchers better understand cancer biology. This information may lead to~     new methods for diagnosing or treating cancer. To develop these studies, researchers want to~     collect samples from people with cancer or precancer conditions of the lymph system. These~     conditions include multiple myeloma, different types of lymphoma, and adult~     leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor~     and skin tissue.~      Objectives:~      - To collect tissue samples to study different types of lymph cancer.~      Eligibility:~      - Individuals at least 18 years of age who have a lymphoid cancer or precancer condition.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Different samples will be collected for study. Blood samples will be collected at the~          initial testing. More blood samples will be collected at different treatment points.~          Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue~          and skin tissue biopsies will also be collected for study.~        -  Treatment will not be provided as part of this study.~   "
144437|NCT01676792|"~     This pilot clinical study is to evaluate the efficacy & safety of SR-T100 gel (2.3% of SM in~     Solanum undatum plant extract) in patients with VIN(s) or EGW(s).~   "
144438|NCT01676779|"~     This is an open label, 2-arm, 1-stage, randomized controlled phase II study in patients with~     AJCC stage IIIB/C & -IV melanoma. At baseline tumor assessment (using total body FDG-PET/CT),~     patients should be free from measurable tumor lesions (according to RECISTv1.1 definitions)~     following prior local therapy (e.g. following surgical resection, isolated limb perfusion,~     radiofrequency ablation, cryotherapy, radiotherapy, electrochemotherapy, …). Patients should~     not have symptomatic non-measurable tumor lesions (e.g. bone metastasis, or pleural~     effusion), and lesions treated by prior local therapy should be free from progression.~     Patients should not have received any prior systemic therapy (non-experimental or~     experimental).~   "
144439|NCT01676766|"~     The purpose of this study is to utilize flavoprotein fluorescence and fundus autofluorescence~     to detect progression of Stargardt macular dystrophy in a pediatric population over the~     course of a year with the hope of aiding future therapeutic risk-benefit decisions and~     assessment of outcomes.~      Stargardt macular dystrophy is the most common of the juvenile-onset macular dystrophies.~     Despite determination of ABCA4 as the causative gene, clinicians have been challenged by~     variability in clinical phenotypes. Given the recent initiation of clinical trials to assess~     novel treatments (e.g. gene therapy), there is a need to identify patients with the worst~     prognosis.~      The investigators have observed that pediatric patients lose central visual function faster~     than their adult counterparts. Thus, they present an ideal cohort with which to determine the~     utility of novel modalities to detect early change. These include flavoprotein fluorescence,~     a new imaging technique for detecting mitochondrial dysfunction developed at the University~     of Michigan. Fundus autofluorescence (FAF) is another commonly utilized technique of~     evaluating hereditary eye diseases. The investigators have developed a novel means of~     quantifying FAF signatures that will allow documentation of severity as well as detection of~     progression.~   "
144440|NCT01676753|"~     The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose~     (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced~     breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients~     with metastatic or locally advanced and unresectable triple negative breast cancer, to~     evaluate the efficacy of combined dinaciclib and pembrolizumab.~   "
144441|NCT01676740|"~     To establish the efficacy of screening for anemia and treatment of mild anemia with iron and~     vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative~     allogeneic blood transfusion.~   "
144442|NCT01676727|"~     This study is intended to collect data regarding the clinical utility, safety and performance~     of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in~     patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic~     access (DA) is selected. As part of the study analysis, resource utilization together with~     the Quality of Life questionnaires data will provide an important input into cost~     effectiveness analysis.~   "
144443|NCT01676714|"~     The purpose of this study is to find out if dovitinib is an effective treatment for patients~     with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on~     anti-vascular endothelial growth factor (VEGF) treatment.~   "
144444|NCT01676701|"~     The purpose of this study is to evaluate the serum concentration of tabalumab after the~     administration using either prefilled syringe or auto-injector after the initial loading dose~     and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety~     extension.~   "
144445|NCT01676688|"~     The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at~     home or in out-of hospital locations.~   "
144446|NCT01676675|"~     Influenza is an acute respiratory infection caused by influenza virus with high incidence and~     serious complications even causing death. According to the announcement released by the World~     Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2 billion~     and 0.5 to 1 million people died. The emergence of a new subtype of influenza virus may cause~     an influenza pandemic with occurence once every 10 to 50 years which cause serious adverse~     consequences for human health and social welfare worldwide.~      From 1997 to 2003，the H5N1 virus infection has increased highly and gradually spreaded to~     Europe, Africa and other countries and regions. High mortality caused by H5N1 virus has~     attracted the WHO and national government great attention. So it is meaningful to develop~     vaccine to provide effective antibody to reduce the number of infections.~      The objective of this study is to evaluate the safety and preliminary immunogenicity of a~     whole virus inactivated influenza H5N1 vaccine.~   "
144447|NCT01676662|"~     The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace~     Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence~     (SUI) in adult females.~   "
144448|NCT01676649|"~     The safety of the combination of ipilimumab with carboplatin/paclitaxel treatment with two~     different dosing schedules will be investigated in patients with metastatic melanoma. This~     protocol will also investigate both the clinical benefit of this combination and the features~     of the host immune system that may predict response to ipilimumab with chemotherapy in~     patients with unresectable Stage III and Stage IV melanoma.~   "
144451|NCT01676610|"~     Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign~     of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid,~     portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation~     (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting.~     In this research study, we propose to test the hypothesis that the use of pulse oximetry to~     detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible~     for the identification of the infants most urgently in need of medical care. We will enroll~     1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi.~     Infants will undergo brief clinical assessment by a community health worker (CHW) based on~     the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm,~     assessment by two pulse oximetry devices, and examination by a physician. The primary~     outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain~     measurement, number of infants for who repeat measurements are required), and concordance~     between paired measurements on separate devices.~   "
144452|NCT01676597|"~     -  The study will be a prospective open labelled double blinded randomized controlled~          study.~        -  The study will be conducted on patients admitted to Department of Hepatology from 2012~          to 2014 at Institute of Liver and Biliary Sciences, New Delhi~        -  Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be~          started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.~        -  Patients not responding to this therapy will be given divided into 2 arms with one arm~          receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 weeks.~   "
144453|NCT01676584|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers.~     Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135~     or placebo subcutaneously.~   "
144454|NCT01676571|"~     The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu~     AA21004 (Vortioxetine) in the Chinese population.~   "
144455|NCT01676558|"~     Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in~     Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use~     aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status,~     refractoriness, and relapsed disease still remains. So we investigate the efficacy of~     radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.~   "
144456|NCT01676545|"~     (A retrospective case control study to validate the association between Interleukin-1 gene~     variations and adult chronic periodontal disease in Chinese (Shanghai))~   "
144457|NCT01676532|"~     This is a prospective cross sectional study to assess the feasibility of a school based~     health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in~     Toronto. The SBHC allows inner-city children who face barriers to accessing health care the~     opportunity to receive health care in their school.The primary aim of this study is to~     determine utilization of the SBHC. Establishing feasibility of the SBHC would support further~     development and expansion of this program into other inner city schools.~   "
144458|NCT01676519|"~     Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary~     intervention (PCI) in whom development of critical limb ischemia was prospectively assessed~     by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary~     endpoint of the study.~   "
144459|NCT01676506|"~     Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis)~     treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).~   "
144460|NCT01676493|"~     This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate~     in pediatric subjects with mild to moderate post-procedural pain.~   "
144461|NCT01676480|"~     The purpose of the present study is to investigate if endurance training can be used as a~     therapeutic action against the adverse metabolic disturbances and unfavourable changes in~     body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate~     cancer patients.~   "
144462|NCT01676467|"~     This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers~     and normal healthy subjects, to compare the biological markers of disease and inflammation.~   "
144463|NCT01676454|"~     The purpose of this study is to determine if vasopressin is used up by the body during~     traumatic shock (severe low blood pressure due to trauma).~   "
144464|NCT01676441|"~     This phase II/III clinical trial is designed to evaluate the safety and efficacy of~     autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.~   "
144465|NCT01676428|"~     This is a proof of concept study, to assess the feasibility of introducing a novel~     high-precision radiotherapy technique called stereotactic radiosurgery (SRS) or~     stereotactic body radiotherapy (SBRT) for the treatment of kidney cancers in Australia.~     This study aims to invite 20 patients with renal cell carcinoma and 10 patients with isolated~     adrenal metastases from non-small cell carcinoma who are either medically inoperable, high~     risk for surgery, or decline surgery to participate. In cohort of patients with renal cell~     carcinoma, both patients with primary disease only, and those patients who have limited~     metastases (≤5) will be eligible. Besides technical feasibility of delivering this treatment,~     this study will be to assess efficacy, toxicity and tumour response using a novel imaging~     biomarker called diffusion weighted-MRI.~   "
144466|NCT01676415|"~     The purpose of this study is to determine the most effective route to administer steroids to~     patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with~     nasal polyps (CRSsNP). The investigators would like to better understand whether orally~     administered steroids results in superior results when compared with nasally sprayed~     steroids. The investigators propose to test the hypothesis that for patients with~     radiographically proven CRSsNP, routine medical therapy consisting of a short course of~     systemic corticosteroids is superior to topical corticosteroids for relieving inflammation~     and the symptoms of CRS.~   "
144468|NCT01676389|"~     The purpose of this study is to determine how osteopathic manual medicine (OMM) will affect~     core autism features including social and communication deficits. The investigators believe~     that OMM approaches can positively influence some features associated with Autism/Autism~     Spectrum Disorder (ASD).~   "
144469|NCT01676376|"~     Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate~     feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an~     external vein support device for use over saphenous vein grafts during coronary artery bypass~     surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh~     (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study~     subject will receive one SVG with the eSVS Mesh.~   "
144470|NCT01676363|"~     Diflunisal is an anti-inflammatory drug (like ASA or ibuprofen) that has been used as a~     painkiller for 20 years. Recent research shows that it may have an anti-HIV effect in the~     laboratory. Approximately 20 HIV-infected adults who are not receiving antiretroviral therapy~     will be given diflunisal by mouth twice daily for 4 weeks, at a dose that has been shown to~     be safe when used to treat pain. Subjects will be monitored closely for safety and will have~     frequent blood tests during the study to see if the drug has any effect on the level of HIV~     in their blood.~   "
144471|NCT01676350|"~     By doing this study, the investigators hope to learn whether patients with difficult to~     obtain IV access who are treated with IO access are more satisfied with their care and have~     better outcomes. The investigators are specifically studying the time difference between~     groups and the difference in the number of attempts required to obtain vascular access and~     begin to treat with fluids and medications. The study will also measure patient satisfaction~     and procedural pain, the frequency of central line placement, the length of stay in the~     hospital and emergency department, and adverse events to intravascular access to determine~     whether IO access can improve these measures.~      The investigators hypothesize that the use of a protocol utilizing an IO device for select~     patients with failed IV access will reduce the time requirements to obtain vascular access,~     reduce the number of attempts needed to obtain IV access, reduce the ED LOS, and have no~     negative impact on patient satisfaction compared to the current ED practices.~   "
144472|NCT01676337|"~     This project proposes administer and evaluate via a randomized controlled trail a text~     message-based appointment reminder system to promote attendance at clinic appointments after~     ED discharge.~   "
144473|NCT01676324|"~     Hypothesis:~      Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with~     Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to~     colonoscopy in the management of patients with Inflammatory Bowel Disease.~      Objectives:~      By means of a survey from the ordering physician we would assess:~      Primary Endpoint~      1. The Percentage of time that the Fecal Calprotectin result caused the physician to change~     the management of a patient.~      Secondary Endpoints~        1. To determine if the Fecal Calprotectin result influenced the number of endoscopies~          performed~        2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when~          endoscopy was performed.~        3. To assess the correlation between the Fecal Calprotectin level and symptoms as measured~          by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if~          endoscopy was performed).~   "
144474|NCT01676311|"~     We will explore the use of Huperzine A in patients who have sustained a moderate to severe~     Traumatic Brain Injury. We aim to determine whether Huperzine A, as compared with placebo,~     would have an effect on memory function after TBI. Additionally, we aim to determine whether~     use of Huperzine A in these patients can change brain activity (as indexed by EEG and~     Transcranial Magnetic Stimulation - TMS), and reduce prevalence/frequency of post-traumatic~     seizures. We also aim to evaluate the safety of Huperzine A in this population as compared~     with placebo.~   "
144475|NCT01676298|"~     The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a~     qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and~     *17 genotypes from genomic DNA obtained from buccal swab samples. The objective of the study~     is to evaluate the performance of the FRX System under multivariate conditions including~     different days, sites, operators and systems.~   "
144476|NCT01676285|"~     Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with~     cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of~     complications in liver disease. The purpose of this prospective, randomized trial is to~     determine whether metoprolol succinate can revert cardiac dysfunction secondary to cirrhosis~     (cirrhotic cardiomyopathy), and prevent complications (renal dysfunction, mortality). A total~     of 100 patients with cirrhotic cardiomyopathy will be randomized (Group R) to receive~     metoprolol succinate or placebo; other 25 patients without cirrhotic cardiomyopathy (Group F)~     will only be followed up without medication. All patients will be evaluated in the beginning~     and again after six months. The assessment protocol includes clinical evaluation,~     electrocardiogram, echocardiogram, laboratory analysis and life quality questionaire. The end~     points will be cardiac remodeling, electrophysiologic changes, sympathetic activity,~     laboratory issue changes, renal function, quality of life, and mortality.~   "
144477|NCT01676272|"~     Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers,~     data comparing one type of modality to another are scarce. This investigation is a~     prospective randomized study comparing a bioengineered skin substitute to a human skin~     allograft.~   "
144478|NCT01676259|"~     In this Phase II study a dose of 2.8 mg (eight 0.35 mg siG12D-LODERs) will be administered in~     12-week cycles to patients with unresectable locally advanced pancreatic cancer combined with~     chemotherapy treatment.~      Primary Outcome:~      - Progression-free survival (PFS) in the study population.~   "
144479|NCT01676246|"~     Flupirtine is metabolized in-vitro via carbamate cleavage and N acetylation to glucuronides~     and mercapturic acid derivatives. The formation of reactive, toxic intermediate products may~     be influenced by genetic polymorphisms of the involved conjugative metabolic pathways. So the~     purpose of this study is to measure pharmacokinetics, metabolism and analgesic effects of~     flupirtine in dependence on the function of NAT2, UGT1A1 and GSTP1.~   "
144491|NCT01676090|"~     To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like~     growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex~     and pubertal stage of a healthy paediatric Spanish population.~   "
144653|NCT01673971|"~     The investigators hypothesize that there are differences between infantile hemangiomas (IH)~     during the proliferating and involuting phases and in response to medical treatment that can~     be detected by optical tomography of these hemangiomas.~   "
144480|NCT01676233|"~     Primary Objective:~      - To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a~     new formulation of insulin glargine and Lantus at steady state~      Secondary Objectives:~        -  To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose~          (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;~        -  To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters~          (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));~        -  To compare the occurrence of hypoglycemia between the 2 treatments;~        -  To assess the safety and tolerability of a new formulation of insulin glargine.~   "
144481|NCT01676220|"~     Primary Objective:~      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of~     change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants~     with type 2 diabetes mellitus~      Secondary Objectives:~      To compare a new formulation of insulin glargine and Lantus in terms of:~      - occurrence of nocturnal hypoglycemia~   "
144482|NCT01676207|"~     In contrast to the extensively studied coronary collateral circulation within the heart,~     clinical attention has been paid only anecdotally to extracardiac-to-coronary anastomoses.~     Usually this has been in the form of case reports giving account of angiographically visible~     anastomoses between the coronary circulation and the internal mammary artery (IMA), typically~     in the presence of a chronic occlusion of a coronary artery. In the anatomical literature,the~     most common types of extracardiac anastomoses include bronchial-to-coronary-artery and~     IMA-to-coronary-artery connections. Anastomoses between the IMA and the coronary circulation~     have been documented to occur in 12% of post-mortem patients with CAD.~      Importantly, hitherto existing observations typically have relied on visual methods~     insensitive for the adequate detection especially of structurally present but poorly~     functional anastomoses. On a diagnostic coronary angiogram, collaterals are visible only if~     the recipient vessel is subtotally stenotic or fully occluded, or can be rendered visible~     during coronary spasm or by temporary balloon occlusion of the recipient artery and~     simultaneous injection of contrast medium into the other arteries, respectively. Similarly,~     the macroscopic pathologic postmortem examination is likely to underestimate the true number~     of extracardiac coronary collaterals.~      The purpose of this study is to determine the in vivo prevalence and functional distribution~     of IMA-to-coronary collateral supply via both the right and the left coronary artery.~   "
144483|NCT01676194|"~     The hope to treat more patients with hepatocellular carcinoma successfully is however~     tempered by the shortage of donors leading to an increasing waiting time for liver~     transplantation (LT). Intention-to-treat analysis have showed that the reported excellent~     long-term outcome is curtailed and significantly hampered by the growing incidence of~     patients who must be removed from the waiting list because of tumor progression. A way to~     face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic~     options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most~     common modality used. While there are many studies concerning TACE in this setting, none are~     controlled studies and thus there is no firm evidence concerning its efficacy in reducing~     drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial~     complications…) while waiting for LT. Most of the available data have been based upon~     analysis of patients who received a transplant and have not included patients who were~     eligible for LT but died, or showed progression, before it could be performed. Therefore,~     studies conducted on an intention-to-treat basis are needed to clarify the benefit and the~     risks of TACE prior to LT in patients with hepatocellular carcinoma.~   "
144484|NCT01676181|"~     Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in~     treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.~   "
144485|NCT01676168|"~     Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.~   "
144486|NCT01676155|"~     To compare the serum apoptosis-associated markers between patients with active TB and~     patients with LTBI To evaluate the efficiency of apoptosis-associated markers to~     differentiate potential of active TB from LTBI~   "
144487|NCT01676142|"~     1. To compare TLR-2 expression of peripheral blood mononuclear cells and serum downstream~          cytokines in those with MAC or MAB pulmonary infection and those with MAC or MAB~          pulmonary colonization and controls.~        2. To investigate the response of TLR-2 expression and cytokines activation to NTM~          stimulation test in patients with MAC or MAB pulmonary infection and colonization and~          controls.~        3. To validate the NTM stimulation test for NTM pulmonary infection.~   "
144488|NCT01676129|"~     The purpose of this study is to measure the effect of nocipoint therapy on patients with~     temporomandibular joint disorders (TMD) and compare it with the effect of standard electrical~     stimulation therapy.~   "
144489|NCT01676116|"~     This trial is conducted in Europe, Oceania and the United States of America (USA).~      The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in~     controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like~     peptide-1 (GLP-1) receptor agonist and OAD therapy.~   "
144490|NCT01676103|"~     The objective of this experiment is:~        -  Primary: To determine the effects of tyrosine supplementation on orthostatic hypotension~          in people with PD.~        -  Secondary: To determine the effects of tyrosine supplementation in people with PD with~          autonomic insufficiency on HR, BP, and norepinephrine responses during acute exercise~          stress.~      Orthostatic hypotension and autonomic abnormalities are a common problem for individuals who~     suffer from PD, especially as it leads to lightheadedness and falling. For those affected, it~     can drastically reduce quality of life. It has been hypothesized that tyrosine may impact~     upon individuals suffering from PD. There is ample evidence in animal models that supports~     our theory; however there is no clinical evidence of the impact tyrosine supplementation may~     have in PD patients who suffer from orthostatic hypotension and blunted BP and HR responses.~     Positive findings that supplemental tyrosine increases BP and HR in people with PD during~     daily activities such as standing up from a chair and walking can lead to new therapies to~     improve Parkinsonian orthostatic hypotension.~      Hypothesis We will test the hypothesis that symptomatic individuals with PD on dopamine~     therapy who suffer from orthostatic hypotension and blunted HR and BP responses will improve~     after tyrosine supplementation.~   "
144492|NCT01676077|"~     The Clinical Outcome Study for Dysferlinopathy is being performed in centres in Europe (UK-~     Newcastle; Spain- Barcelona, Sevilla; Germany- Berlin, Munich; Italy- Padova; France- Paris,~     Marseille), USA (Charlotte, NC; Columbus, OH; Washington, DC; St.Louis, MO, Stanford CA),~     Japan (Tokyo) and Australia (Sydney). Oversight and funding for this study is being provided~     by the Jain Foundation, a non-profit foundation dedicated to finding therapies for~     dysferlinopathies(LGMD2b/Miyoshi). The aim of this Clinical Outcome Study is to determine~     the clinical outcome measures required for future clinical trials, characterize the disease~     progression of dysferlinopathy and collect biological samples for the identification of~     disease markers that are needed to non-invasively monitor the disease during clinical trials.~     Without this information, effective clinical trials cannot be performed.~      This study is recruiting a large number of genetically confirmed dysferlinopathy patients~     aged 10 years or older, who are ambulant or non-ambulant. Participants will be assessed at 6~     visits over 3 years via medical, physiotherapy, and MRI/MRS assessments, as well as standard~     blood tests. Optionally, the participants can donate blood samples and a skin sample for use~     in the identification of disease markers and other approved research.~   "
144493|NCT01676064|"~     The aim of this study was to quantify the Intraocular Pressure (IOP) changes in patients~     undergoing laparoscopic hysterectomy at different time points and body positions throughout~     the procedure, and to explore the influence of perioperative fluid management on the~     fluctuations of IOP during perioperative period.~   "
144494|NCT01676051|"~     The purposes of this study are to identify the common bacterial flora on the hand and~     evaluate the efficacy of readily available skin-preparation solutions in the elimination of~     bacterial pathogens from the surgical site following skin preparation. The null hypothesis is~     that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in~     pre-operative skin preparation in clean, elective hand surgery cases.~   "
144495|NCT01676038|"~     The success of total knee arthroplasty depends on a number of factors including pre-operative~     range of movement, obesity, medical comorbidities, prosthesis design, preparation and~     implantation of the prosthesis, soft tissue balancing, as well as implants alignment. Optimal~     placement of the implants within 3° of the mechanical axis of the lower limb has been proven~     to reduce wear and early implant failure.~      Compared to conventional techniques, computer-Aided Navigation total knee arthroplasty has~     been widely used in the last decade and have been proven to improve the accuracy of~     prosthesis placement and lower limb alignment by reducing the number of outliers with more~     than 3° deviation from the mechanical axis. However, its use also involves a steep learning~     curve, high initial capital cost and longer duration of surgery.~      Traditional computer-navigated TKA using optical tracking systems also requires fixation of~     the femoral and tibial reference arrays to bone using anchoring pins. Complications reported~     with the use of these pins include either femoral or tibial fracture, pin site pain, pin site~     infection and osteomyelitis. The investigators study aims to investigate the accuracy of a~     new pinless navigation system for TKA that will avoid these complications.~   "
144496|NCT01676025|"~     The purpose of this study is to compare two surgical methods of adrenalectomy. One is called~     PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at~     patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through~     patient's abdominal cavity after making 3 or 4 holes in the abdomen.~   "
144497|NCT01676012|"~     Through technological improvement a new technique has become available in the form of~     high-definition (HD-) bronchoscopy. Current normal video white light bronchoscopy is the~     standard, and video-autofluorescence bronchoscopy (AFB) is offered by specialized centers~     only. The impact of this development with high-definition videobronchoscopy using a 1.1~     megapixel chip on the diagnostic performance of bronchoscopy is however unknown.~      The aim of the present study therefore is to explore the diagnostic performance (sensitivity~     and specificity) of HD-videobronchoscopy, HD + surface enhancement (iScan filtering~     technique) and HD + tone enhancement filtering in comparison to standard WLB and dual mode~     SAFE3000 autofluorescence videobronchoscopy in a high risk population.~   "
144498|NCT01675999|"~     In patients with locally advanced colon cancer (high risk stage II and stage III), curative~     surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However,~     for 30-40% of these patients, the current curative treatment strategy of surgical excision~     followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate~     distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an~     attractive concept for locally advanced colon cancer and has the potential to impact upon~     both of these causes of failure. Optimum systemic therapy at the earliest possible~     opportunity may be more effective at eradicating distant metastases than the same treatment~     given after the delay and immunological stress of surgery. Added to this, shrinking the~     primary tumor before surgery may reduce the risk of incomplete surgical excision, and the~     risk of tumor cell shedding during surgery.~      ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy (response~     rate) and feasibility (safety, tolerance) of these two chemotherapy regimens (FOLFOX-4 alone~     and FOLFOX-4+Cetuximab) in a neoadjuvant strategy in patients with locally advanced colon~     cancer. Control arm includes patients for whom standard treatment comprises surgery followed~     by adjuvant FOLFOX-4 chemotherapy. This phase II study will assess the feasibility of a~     neoadjuvant strategy in these patients and determine which neoadjuvant regimen is the most~     effective in terms of response rate.~   "
144499|NCT01675986|"~     The insertion of long-lasting intravenous device is done under local anesthesia. Currently,~     in the investigators hospital, no premedication is given to the patients. However, this~     procedure occurs in a particular emotional context related to the diagnosis of cancer or~     malign hemopathies.~      Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure~     can be questionable.~      Hydroxyzine is the reference molecule for premedication because of its anxiolytic and~     anti-histaminic properties A new agent, pregabalin, shares also the same properties~      The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on~     the anxiety score as a premedication during the insertion of long-lasting intravenous device~     under local anesthesia.~   "
144500|NCT01675973|"~     The purpose of this study is to assess the effect of severe renal impairment on the~     steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects with~     normal renal function.~   "
144502|NCT01675947|"~     This study will seek to enroll 50 persons who have central or non-central geographic atrophy~     (GA) associated with age-related macular degeneration (AMD). GA in treated eye must be~     between 0.75 disk areas (DA) and 8 DA. Eligible participants will be randomly chosen to~     receive one of the following treatments in the study eye:~        1. A 20 μL (440 μg) intravitreal (IVT) injection of sirolimus, or~        2. A sham treatment (subconjunctival injection of lidocaine) Participants with two (2)~          eligible eyes will have one eye randomly assigned to receive intravitreal sirolimus and~          no sham in the fellow eye.~      The first injection will begin at Day 0, which may occur on the date of screening/enrollment~     or up to two weeks following screening/enrollment visit, and every month thereafter. The~     visit schedule is as follows:~        1. A clinical evaluation, including safety measures, will occur monthly.~        2. Vision will be measured at the screening/enrollment visit and at 2, 3, 6, 9, 12, 18 and~          24 months after the first injection has occurred.~        3. Fundus autofluorescence will occur at screening/enrollment and at 2, 6, 12, 18 and 24~          months after the first injection has occurred.~        4. Fundus color photography and optical coherence tomography will occur at~          screening/enrollment and at 6, 12, 18 and 24 months after the first injection has~          occurred.~      The primary goal is to evaluate whether the persons receiving the sirolimus injections show a~     slower worsening of geographic atrophy compared to the persons receiving the sham injections.~     A secondary goal is to evaluate the impact of sirolimus on vision compared to the sham.~      NOTE: As of May 30, 2014, study injections were discontinued due to safety concerns. No~     further enrollments will occur and follow-up will continue on all active study participants~     on a quarterly basis. That is, on visits coinciding with 3 month intervals from date of~     enrollment.~   "
144503|NCT01675934|"~     Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in~     the proximal colon compared to the distal colon. Possible reasons for this include bowel~     preparation often being worse in the proximal colon as well as flat depressed lesions being~     more common in the proximal colon.~      Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the~     proximal colon is not currently routinely performed due to concerns of perforation and~     possibly because of the increased time required.~      Proximal colon retroflexion has been shown to be safe and effective without any~     complications, but data regarding ability to retroflex with certain types of colonoscopes is~     limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric~     colonoscopes. Studies have not been performed to comparatively evaluate the success rates of~     standard adult and pediatric colonoscopes and whether either type of instrument confers a~     greater polyp detection rate.~   "
144504|NCT01675921|"~     The investigators hypothesize that at the end of the 12-month trial, teenagers regularly~     self-monitoring their asthma control with ACT administered through Facebook will have~     improved ACT scores as compared with teenagers receiving usual care.~   "
144505|NCT01675908|"~     Compare the performance of full covered metal stents and plastic stents for preoperative~     biliary decompression~   "
144506|NCT01675895|"~     The main objective was to test the hypothesis that adding lidocaine to hyperbaric~     levobupivacaine could change the duration of levobupivacaine spinal block.~   "
144507|NCT01675882|"~     The objectives of this dose-finding study for the treatment of peanut allergy are:~        -  To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg~          peanut protein per patch) to significantly desensitize peanut-allergic subjects to~          peanut after 12 months of treatment.~        -  To evaluate the safety of a long-term treatment with Viaskin Peanut.~   "
144508|NCT01675869|"~     The purpose of this study is to see if an intervention training executive functions like~     attention, working memory, and self-regulation for preschoolers at risk for~     Attention-Deficit/Hyperactivity Disorder is feasible, acceptable to families, and improves~     attention, behavior, and functioning.~   "
144509|NCT01675856|"~     Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The~     condition accounts for 150 per 100,000 populations. A National United Kingdom reported a~     crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of~     patients at their presentation, there remains a subgroup of patients who continue to bleed or~     develop recurrent bleeding. In these patients, the mortality increases manifolds. If these~     high-risk patients can be identified, early interventions may improve their outcomes.~      Several prognostic indices are in use for the purpose of patient stratification. They include~     the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite~     score which incorporates clinical parameters as well as findings during endoscopy which was~     derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the~     prediction for the need of further intervention loosely defined as the need for transfusion,~     endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for~     early discharge.~   "
144510|NCT01675843|"~     The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy~     rates in women with polycystic ovary syndrome. Infertile women with pcos will receive~     gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse~     (TI)~   "
144511|NCT01675830|"~     This is a phase I descriptive pilot study to determine the feasibility of using the Heat~     Retention Head Wrap on infants during the re-warming period following cardio-pulmonary~     bypass.~   "
144512|NCT01675817|"~     Recent work has shown that heparin rebound is common after cardiac surgery.~      The exact doze of protamine required to neutralize heparin at the end of CPB is unknown.~     Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also~     unknown if precise titration of protamine perioperatively in cardiac surgery can influence~     transfusion requirements after cardiac surgery.~   "
144513|NCT01675804|"~     Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation~     (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of~     children with attention deficit/hyperactivity disorder (ADHD).~   "
144514|NCT01675791|"~     The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree~     AIT administered once daily in order to define a dose-range that would be suitable for~     at-home administration.~   "
144515|NCT01675778|"~     Pain is the most common complaint for patients presenting to the emergency department (ED).~     Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and~     responses to intravenous opioids vary widely and are influenced by multiple factors. The~     objective of the current study is to examine the association between total body weight, BMI~     (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.~   "
144572|NCT01675037|"~     Background: Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment~     of obstructive hydrocephalus in children and adults. Perforation of the third ventricle floor~     which is part of the hypothalamic-pituitary neuronal network is the key of this surgical~     procedure.~      Purpose: There are no prospective data available about the endocrine effects after ETV in~     children and adults. The principal aim of this prospective study is to evaluate the~     variability of hypothalamic-pituitary hormones and clinical effects in children and adults~     after ETV in order to plan a multicentric study.~   "
144516|NCT01675765|"~     This clinical trial will evaluate the safety and immune response of the sequential~     administration cancer vaccine CRS-207 (with or without cyclophosphamide) followed by standard~     of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of~     Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause~     disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been~     engineered to elicit an immune response against the tumor-associated antigen mesothelin,~     which has been shown to be present at higher levels on certain tumor cells (such as~     mesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy~     regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving~     CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or~     objective tumor response.~   "
144517|NCT01675752|"~     1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol~     Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and~     adenomatous <10 mm polyps with that of histology in an European multi-center study. To assess~     variability among endoscopists in NBI accuracy. We also aim to assess whether this technology~     impacts the appropriateness of surveillance intervals.~      Design: 1) Before starting the patient enrollment, the participating endoscopists will attend~     an internet-based training program on the in vivo differentiation between hyperplastic and~     adenomatous polyps. Following this course, a qualifying examination will be required for each~     endoscopist to be included.~      2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for~     inclusion. Patients with at least one histologically verified <10 mm polyp will be included.~     In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in~     order to rank between a high- and a low- level of diagnostic confidence, and thereafter will~     be sent for histological assessment. NBI- and histological accuracy in differentiating~     between hyperplastic and adenomatous lesions will be analyzed and compared, in order to~     assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI~     feasibility and accuracy in the study population, and to assess the variability among the~     endoscopists. Secondary outcome measures will be a cost analysis on how much savings would be~     achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical~     inference on how many patients would be scheduled for an inappropriate post-polypectomy~     follow up, when follow up schedule is based on NBI classification. Clinical results will be~     analyzed using various statistical measures of significance.~      Clinical Site Locations: 10 European centres with NBI-technology~      1 NBI-expert endoscopist for each centre Enrollment: 160 small (<10 mm) polyps at each site~     Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.~   "
144518|NCT01675739|"~     The purpose of this study is to evaluate the effectiveness of SMS (short message service of~     mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.~   "
144519|NCT01675726|"~     AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very~     preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL~     reported by a French general population of reference. 3) to determine whether~     socio-demographic factors, neonatal features and neurocognitive status were impacting their~     QoL.~      METHODS:~        -  Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier,~          Nantes, Nîmes, Nice and Rouen).~        -  Inclusion criteria: all infants born before 28 weeks of gestation between January 2005~          and December 2007, from 7 to 9 years old of age at the time of evaluation.~        -  Written agreement to participate: collected from parents.~        -  Data collection: reports of children's QoL by children and their parents (using~          standardized validated questionnaires); clinical information about the children,~          obtained through a medical examination; children neurocognitive profile.~        -  Duration of inclusion: over 24 months.~        -  Population: of the six structures, approximately 300 children will be evaluated~          consistent with the active files of the participating centres and an attrition rate of~          30%.~      PERSPECTIVES This is one of the first studies to collect self-reported data on quality of~     life of school-age children (7-9 years) born before 28 weeks of gestation. A better~     understanding of demographic and clinical determinants of QOL of school-age very preterm~     children may help clinicians involved in the care of these children in their ethical and~     medical considerations.~   "
144520|NCT01675713|"~     The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (> 1~     year) term effects on body composition and psychological health after a 10 to 14-weeks~     comprehensive lifestyle modification program for the treatment of severe obesity.~      The aims of the PhD project are to investigate whether an intensive lifestyle intervention~     leads to acute and short term (< 1 year) changes in:~        1. The BMI/Weight~        2. Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and~          visceral fat area)~        3. Psychosocial factors such as eating behavior, anxiety and depression symptoms and~          health-related quality of life~   "
144521|NCT01675700|"~     The purpose of this study is to determine whether a topical nitroglycerine patch applied~     daily over a trapezius trigger point can improve patients' symptoms.~      If there is improvement, this open label study will help determine the degree of improvement~     and contribute to the design of a larger double blind placebo controlled trial.~      We would consider moving forward to a large randomized trial if:~        -  The intervention is acceptable to patients (>= 70%) and~        -  Compliance is satisfactory (>=80%) and~        -  We find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the~          VAS.~   "
144522|NCT01675687|"~     This study is designed to verify that web based follow up intervention after a classic~     multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise~     self-efficacy, improve drop out rate and advance sustainability after weight loss of obese~     women.~      Research Questions and Hypotheses~        -  How does a web based follow up intervention change self-efficacy of women participating~          in an obesity intervention?~        -  How does a web based follow up intervention affect the drop out rate of women~          participating in an obesity intervention?~        -  How does a web based follow up intervention influence sustainability of women~          participating in an obesity intervention?~   "
144523|NCT01675674|"~     This study is being done to learn how many children and young adults who come to pediatric~     rheumatology clinics may have mucopolysaccharidosis (MPS). The study tests for 4 of the types~     of MPS: I, II, IVA, and VI. This can help researchers decide whether to create a screening~     program for MPS at pediatric rheumatology clinics. This study is being done in rheumatology~     clinics because the first symptoms of MPS are often joint problems such as stiff joints, and~     rheumatologists may be the first doctors that a patient with MPS visits. The study will also~     evaluate the utility of dried blood spot testing for MPS.~   "
144524|NCT01675661|"~     The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200~     mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on~     cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).~   "
144525|NCT01675648|"~     In Singapore, opiate substitution medication e.g. methadone is only licensed for use with~     specific population. The standard treatment is one week of detoxification assisted with~     diazepam and symptomatic treatment followed by one week of rehabilitation. However, diazepam~     is highly addictive and widely abused among heroin users and pharmacologically, does not~     reduce the physical and psychological craving for opioids which can trigger relapse. Many~     opiate patients undergoing inpatient detoxification leave prematurely (i.e. PID: patient~     initiated discharge) because of the severity of unpleasant withdrawal symptoms. The purpose~     of the study is to establish an alternative medication to reduce opiate withdrawal symptoms~     for use in Singapore by evaluating the clinical efficacy of Lofexidine versus Diazepam in the~     management of the opiate withdrawal syndrome during inpatient detoxification.~   "
144526|NCT01675635|"~     The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized~     patients with moderate to severe pain following surgery.~   "
144527|NCT01675622|"~     The efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus~     morphine immediate-release tablets in the treatment of cancer pain.~   "
144528|NCT01675609|"~     The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate~     0.025% ophthalmic solution used four times daily in a population of adult and geriatric~     subjects~   "
144529|NCT01675596|"~     The objective of the study is to observe the safety, efficacy and cost effectiveness of the~     Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.~   "
144530|NCT01675583|"~     The purpose of this study is to investigate the efficacy of an optical device designed and~     developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized~     that the blood flow velocity of the wound site will provide critical information on the~     efficacy of hyperbaric oxygen therapy.~   "
144531|NCT01675570|"~     The primary purpose of this study is to assess the efficacy, tolerability and safety of~     RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.~   "
144532|NCT01675557|"~     The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses~     to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney~     Disease subjects requiring chronic hemodialysis.~   "
144533|NCT01675544|"~     Purpose of the study: To identify whether Electrocardiographic QRS voltage changes (between~     admission and pre-discharge) and pre discharge 6- minute walk test in patients admitted with~     acute heart failure can identify patients at risk for recurrent admissions for heart failure.~   "
144534|NCT01675531|"~     A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin~     (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy)~     who need opioid combination treatment with existing pregabalin of last dose prior to study~     enrollment without changing.~      The investigators will assess study objectives as below.~      Primary objective~        -  To assess the pain reduction rate after 4 weeks treatment from baseline (week 0)~      Secondary objectives~        -  To assess the Functional Assessment of Cancer Therapy/Gynecologic Oncology~          Group-Neurotoxicity (FACIT-GOG/NTX)~        -  To assess physician's overall satisfaction~        -  To assess subject's overall satisfaction~        -  To assess safety~      The investigators have a hypothesis that Targin will show favorable efficacy & safety profile~     for CIPN patients.~   "
144535|NCT01675518|"~     This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics~     of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is~     administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991~     in fasted and fed conditions are compared.~   "
144536|NCT01675505|"~     The purpose of the study is to investigate whether there are prognostic factors regarding the~     mental and functional adjustment of colon cancer patients following curative surgery.~     Patients will be selected using specific inclusion criteria. Prognostic factors investigated~     include personality characteristics, initial distress, medical, social and economic factors.~     The utmost purpose of the study is to assist clinicians with the timely identification of~     vulnerable patients in order to ensure their proper management and their optimal adjustment.~      Moreover this is the first study using the Distress Thermometer in Greek patients with~     cancer.~   "
144537|NCT01675492|"~     To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and~     effective in the treatment of mixed astigmatism.~   "
144538|NCT01675479|"~     Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe~     and effective for the treatment of Hyperopia.~   "
144539|NCT01675466|"~     Patients with acute abdominal pain comprise a significant proportion of attendances at~     emergency departments. These patients account for about a third of general surgical~     admissions in a typical day. In some cases, the diagnosis is clear from baseline~     investigations (for example in cases of pancreatitis). In other cases, the diagnosis remains~     unclear but there are signs that necessitate urgent surgery (for example in cases of~     appendicitis). A final group exists where no clear explanation for the pain is found and~     where there are insufficient clinical signs to warrant surgery. These patients are said to~     have non specific abdominal pain (NSAP) and present a management dilemma.~      Traditionally such patients are managed with a strategy of active observation. Patients are~     examined at regular intervals and may undergo imaging. In some cases, symptoms and signs~     progress and surgery is needed while in other cases resolution may occur or a diagnosis may~     be reached non-operatively allowing focused medical treatment. Recently, two alternative~     strategies have emerged. Early cross-sectional imaging using CT scanning may identify~     conditions whilst being non-invasive. This would allow diagnosis and treatment would follow.~     The alternative strategy of early laparoscopy (key hole surgery) offers the possibility of~     concomitant therapy, but is invasive.~      The study hypothesis is that in patients with acute non-specific abdominal pain active~     management with laparoscopy on admission will reduce hospital stay and costs when compared to~     traditional active observation, without increasing complications.~   "
144573|NCT01675024|"~     This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine~     after single and multiple doses of Rotigotine transdermal patch, and also to investigate the~     safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.~   "
144540|NCT01675453|"~     The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac~     surgery patients. Systemic inflammatory response initiated by CPB through releasing of~     several mediators lead to altered endothelial integrity and in consequence the leakage of~     proteins and fluids from the intravascular to the interstitial compartment is occurred.~     Increased capillary permeability and decreased colloid osmotic pressure were shown to play a~     key role for fluid shift and increasing of extravascular water. Further tissue edema can~     result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to~     adverse outcomes.~      Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid~     shift from the intracellular and the interstitial spaces of tissue into the intravascular~     compartment.~      The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6%~     hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass~     grafting with cardiopulmonary bypass.~   "
144541|NCT01675440|"~     To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of~     symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the~     risk of surgical aortic valve replacement has a predicted operative mortality or serious,~     irreversible morbidity risk of ≥50% at 30 days.~   "
144542|NCT01675427|"~     This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes~     with disease characteristics and demographics in treatment-naïve and treatment-experienced~     chronic hepatitis C patients, including patients with HIV co-infection. There will be a~     single study visit for testing.~   "
144543|NCT01675414|"~     The purpose of this research study is to help us learn if children with Autism Spectrum~     Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than~     children without ASD do. The investigators hope to learn if children with ASD and~     gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and~     aggression, more than children with ASD but no GI disorders do. The investigators want to~     learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children~     with ASD also have gastrointestinal disorders.~      Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not~     identified by current diagnostic evaluation.~      Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an~     elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing~     children. The investigators anticipate that the proposed study will raise the standard of~     medical care for children with ASD by improving current methods of identifying GI dysfunction~     and determining whether there is a significant relationship between GI dysfunction and PB in~     this population.~   "
144544|NCT01675401|"~     An increased body mass impairs vascular function (VF), an important characteristic of~     subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases.~     However, a wide variety of in vivo VF markers exists each measuring different aspects of VF.~     Each of these markers addresses a different aspect of the vasculature. Studies comparing~     under standardized conditions the differences and relationships of the many different VF~     measurements in lean and abdominally overweight / obese subjects are missing. Also, there is~     a great need to know which of these markers are sensitive to dietary challenges.~      Therefore, it is imperative to conduct an extensive study on dietary effects and~     interrelationships of a broad spectrum of VF measurements and plasma biomarkers in lean and~     overweight / obese subjects. Focus will be on FMD, a well accepted biomarker for~     cardiovascular disease. The investigators propose to examine, in a two-way~     parallel-randomized human intervention study, the effects of weight-loss in abdominally~     overweight / obese men on VF markers and plasma biomarkers related to low-grade inflammation~     and vascular activity during the fasting and both the postprandial and hyperinsulinemic~     state. Furthermore, differences - and relations between - VF measurements and plasma~     biomarkers will be compared cross-sectionally between lean and abdominally overweight / obese~     male subjects.~   "
144545|NCT01675388|"~     Newborn infants with severe respiratory failure are treated with extracorporeal membrane~     oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for~     brain injury as a result of hypoxia and blood flow changes in the brain prior to and during~     ECMO. The investigators propose a clinical trial of a novel treatment (cooling during ECMO)~     and novel diagnostic tool (advanced MRI techniques) that will lead to improved outcomes,~     early diagnosis and intervention for brain injury, decreased cost and duration of clinical~     trials, decrease in the burden of chronic neurologic disease and disability in society, thus~     improving the health and quality of life of these infants as they progress through childhood~     into adulthood.~   "
144546|NCT01675375|"~     The purpose of this research is to determine if an investigational thin shield can~     effectively reduce discomfort following Laser Vision Correction.~   "
144547|NCT01675362|"~     This study will be conducted to evaluate the protective effects and mechanisms of~     antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and~     angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.~   "
144548|NCT01675349|"~     The objective of this study is to determine the biologic activity of a Chenopodium album~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
144549|NCT01675336|"~     A retrospective case control study to validate the association between Interleukin-1 gene~     variations and adult chronic periodontal disease in Chinese (Taiwan).~   "
144563|NCT01675154|"~     Funding Source - FDA OOPD~      This study is being done to find out whether an investigational (not approved by FDA ) drug~     called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in~     combination can treat the high blood fat (elevated triglycerides)levels found in the~     condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone,~     the current standard medical care.~      It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in~     lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The~     researchers are interested in learning whether any one of these drugs when given alone or in~     combination is more effective and safe in treating T1HLP.~   "
144574|NCT01675011|"~     This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years~     with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six~     (36) months following uterine fibroid embolization.~   "
144550|NCT01675323|"~     Restless Legs Syndrome (RLS) research has focused on the sensory features and failed to~     address an important aspect of RLS; i.e. a 'hyperarousal' or profound chronic sleep loss~     without significant excessive daytime sleepiness. This hyperarousal produces RLS symptoms by~     overwhelming the normal inhibitory processes needed to decrease sensory and motor cortical~     activity for resting and sleep. Thus the hyperarousal produces both the RLS need to move when~     trying to rest and the inability to maintain sleep. The biological consequences of this~     hyperarousal process on sleep (increased wake time) and cortical excitability (as~     demonstrated by transcranial magnetic stimulation (TMS)) are postulated to reflect increased~     degree of excitatory glutamatergic activity, and therefore affected brain regions will show~     relatively increased glutamate (Glu) and glutamine (Gln) on MR spectroscopy (MRS). Changes in~     inhibitory activity and GABA may also occur, but less significantly than the increase in~     Glu/Gln. Our pilot MRS data discovered a new abnormality in RLS: increased Thalamic Glx (Glu~     + Gln) that correlated well with sleep measures of hyperarousal. Glx levels are not specific~     for the neurotransmitter role of Glu.~      In this project RLS and matching controls subjects will be studied using polysomnograms (PSG)~     and TMS and 7T MRI for MRS that provides accurate measurement of Gln levels, which reflect~     mostly neurotransmitter Glu activity. The first aim is to confirm that Gln is increased in~     the thalamus and to determine if this also occurs in the motor and sensory cortices. The~     relation between Glu, Gln and GABA will also be evaluated. Second, assessments will be made~     of the degree of relation between Gln increase and the hyperarousal effects on sleep and~     cortical excitability (TMS). This would demonstrate that abnormally increased Glu activity is~     primary to RLS hyperarousal and radically changes the emphasis in RLS to be less on dopamine~     and more on Glu-hyperarousal as a major feature of RLS.This is an entirely new direction for~     RLS research and treatment development. The new concept of hyperarousal adds a missing~     dimension to understanding RLS, namely the discovery of the Glu abnormality and its central~     relation to the other hyperarousal features.~   "
144551|NCT01675310|"~     Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that~     affect between 1 to 14% of population around the world.~      There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican~     population.~      Metformin has been used during pregnancy in women with gestational diabetes and women with~     polycystic ovary syndrome, with acceptable security for mother and fetus.~      Metformin decrease the insulin resistance and weight gain, we believe that metformin may be~     decrease the risk of gestational diabetes mellitus in high risk women.~   "
144552|NCT01675297|"~     The purpose of this study is to evaluate the efficacy and the safety of Risedronate,~     cholecalciferol combination tablet in patients with Osteoporosis.~   "
144553|NCT01675284|"~     The focus of this study is to evaluate the safety, reactogenicity and humoral immune~     responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg~     HA to human subjects.~   "
144554|NCT01675271|"~     The focus of this study is on individualized exercise prescription on primary prevention of~     cardiovascular diseases (CVD). Special attention is set on autonomic nervous system function~     and inflammation.~      This study will seek novel, cost-effective models of exercise prescription that will~     emphasize individuals own response on her health and which would be easily implemented to~     primary health care as primary prevention for CVD. According to power calculation,sixty women~     planning pregnancy with BMI equal or over 30 and/or history of GDM will be recruited and~     randomized to an individual exercise arm (n=20), a general exercise arm (n=20) and a control~     arm (n=20). General intervention group will receive general exercise and dietary counselling~     whereas a personal exercise and dietary programs will be planned for individualized exercise~     group. Those randomized to the control arm will receive no dietary and exercise information.~      Clinical exercise tests and autonomic nervous system tests will be performed in the beginning~     of the study and after 3 months intervention. Blood samples for markers of inflammation,~     glucose homeostasis and lipid status will be collected from prepregnancy period until 1 years~     after delivery.~   "
144555|NCT01675258|"~     Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the~     world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are~     mostly diagnosed only at later stages of the disease's course through histoimmune staining~     and molecular biology processes on the tissues biopsied from the gastrointestinal system~     under invasive diagnostic procedures of colonoscopy.~      Oral fluid presents a large protein complexity and has been recently used as a diagnostic~     biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the~     colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to~     bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal~     cancers. Proteomic technologies provide the tools needed to discover and identify~     disease-associated biomarkers.~      The aim of the present study is to identify salivary bio-markers in patients suffering from~     colorectal cancers.~   "
144556|NCT01675245|"~     The purpose of this study is to acquire information on the usage, effectiveness, safety, and~     levels of health care resource utilization associated with Velcade therapy in recurrent and~     refractory multiple myeloma patients who are initiating Velcade and various combination~     therapies within the approved indication in a naturalistic setting.~   "
144557|NCT01675232|"~     The purpose of this study is to investigate the efficacy of two different corticosteroid~     ointment application regimens for the treatment of eczema (atopic dermatitis).~   "
144558|NCT01675219|"~     Bladder cancer (BC), the second most common urological malignancy, is an important public~     health issue. One of the main challenges in the treatment of bladder cancer if the prevention~     of recurrences of non-invasive tumors, which is also associated with significant costs.~      The current study will investigate optimal treatment of patients with bladder cancer with~     high risk of tumor recurrence but low risk of progression. The main interest is comparison of~     photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy~     of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.~   "
144559|NCT01675206|"~     This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis~     patients.~   "
144560|NCT01675193|"~     The purpose of this study is to determine the optimal screening intervals and~     cost-effectiveness of population-based vision screening in preverbal children in the~     Netherlands.~   "
144561|NCT01675180|"~     Purpose/Objective of the study:~      The main objective of the study is to investigate oral health awareness and attitudes towards~     oral health among Norwegian pregnant women and assess the impact of information about oral~     hygiene on the risk of dental caries during pregnancy.~      The hypothesis of the study are:~        1. The state of oral health during pregnancy depends on pregnant woman's preventive oral~          hygiene behaviour and practice.~        2. Pregnant women with high level of oral health awareness and positive attitude towards~          oral health are more likely to visit their dentists regularly and have better oral~          hygiene compared to those with less awareness.~        3. Proper information and guidance on oral hygiene care provided during pregnancy can help~          to improve oral bacteriological milieu and reduce the dental caries risk among pregnant~          women.~   "
144564|NCT01675141|"~     Background:~        -  Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed~          at controlling symptoms and reducing the number of myeloma cells. It continues until the~          cancer stops responding to treatment. At that time, treatment may switch to maintenance~          therapy, which is given to try to extend the response of the first therapy for as long~          as possible. Research suggests that lenalidomide maintenance therapy may delay the time~          for myeloma cells to start to grow and possibly improve survival.~        -  Lenalidomide is a drug that may reduce or prevent the growth of cancer cells.~          Researchers want to look at the long-term effect of lenalidomide on immune cells. It~          will also look at the effects of extended treatment on the cancer and the immune system.~      Objectives:~      - To test the long-term effectiveness of lenalidomide therapy for multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age with newly diagnosed or relapsed multiple myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          sample will be collected. A bone scan and bone marrow biopsy will also be performed.~        -  Participants will receive lenalidomide maintenance treatment. It will be given according~          to the standard of care for multiple myeloma. Participants will take lenalidomide every~          day for 21 days of repeated 28-day cycles.~        -  Treatment will be monitored with frequent blood tests. Blood tests will look at the~          effect of the treatment on the immune system.~        -  Treatment will continue as long as the cancer does not worsen and the side effects are~          not severe.~   "
144565|NCT01675128|"~     Background:~      - Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the~     deoxyribonucleic acid (DNA) of growing cancer cells. It is most often used with other~     chemotherapy drugs. Researchers want to test it with an experimental drug, ISIS 183750. They~     want to see if the drugs are a safe and effective treatment for advanced solid tumors or~     colorectal cancer that has not responded to other treatments.~      Objectives:~      - To test the safety and effectiveness of ISIS 183750 with irinotecan for advanced solid~     tumors or colorectal cancer.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors or colorectal cancer that has~     not responded to other treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected. Tumor tissue samples may be collected as well before and~          after treatment. Imaging studies will also be performed.~        -  Participants will take ISIS 183750 once a week for 28-day cycles of treatment. On the~          first cycle, they will also have ISIS 183750 on days 3 and 5.~        -  Participants will take irinotecan every second week, beginning on day 15 of the first~          cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Treatment will continue as long as the cancer does not grow and the side effects are not~          severe.~   "
144566|NCT01675115|"~     The objective of this study is to investigate the efficacy and safety of BNG-1 in patients~     with ischemic stroke. The efficacy assessment will be based on the functional outcome while~     the safety will be reviewed by the adverse events and laboratory examinations.~   "
144567|NCT01675102|"~     17p-/p53-mutated chronic lymphocytic leukemia (CLL) is an orphan disease, accounting for~     approximately 5% of newly diagnosed CLL. This subgroup of patients has a very poor outcome~     after chemoimmunotherapy. Allogeneic HCT may change the poor prognosis. In a retrospective~     EBMT-analysis on 44 patients with advanced 17p-CLL 2-year progression-free survival was 45%~     (95% CI, 30% to 60%) after allogeneic HCT (Allogeneic hematopoietic stem-cell transplantation~     for chronic lymphocytic leukemia with 17p deletion: a retrospective European Group for Blood~     and Marrow Transplantation analysis. J Clin Oncol, 2008, 26, 5094-5100).~      Referring to these favorable results and small additional series, patients with 17p-CLL~     requiring therapy are considered to have an indication for allogeneic transplantation by many~     CLL study groups. Several CLL study groups recommend allogeneic HCT in 17p-CLL as part of the~     first- or second line treatment.~      The aim is to collect additional evidence on allogeneic HCT in 17p-/p53-mutated CLL in first~     or second remission by a non-interventional prospective study. Patients shall be registered~     prior to HCT at the Leiden Office in order to rule out a reporting bias after~     transplantation.~   "
144568|NCT01675089|"~     The purpose of this study is to determine whether zolendronic acid, a third generation~     bisphosphonate, is effective in preventing bone loss in the first year after kidney~     transplantation.~   "
144569|NCT01675076|"~     The purpose of this study is to determine the best strategy to manage novel oral~     anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators~     hypothesize that performing device surgery without interruption of the novel oral~     anti-coagulant will result in a reduced rate of clinically significant hematoma.~   "
144570|NCT01675063|"~     The overall goal of this collaborative study is to advance the novel pulse contour analysis~     to the point at which it can be incorporated into a real-time device. The specific objective~     is to establish an auto-calibration algorithm that conveniently yields cardiac output (CO) in~     units of liters-per-minute. To achieve this objective, the waveforms for analysis and~     reference pulmonary artery catheter CO measurements will be recorded from critically ill~     patients and then analyzed off-line at Retia Medical. Successful completion of this study may~     ultimately help lead to improved outcomes of critically ill patients.~   "
144571|NCT01675050|"~     The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover~     trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in~     children, achieving a greater response than that observed with placebo. In addition to~     assessing self-report of pain and other symptoms, the investigators also propose to perform~     experimental somatic pain testing to determine if there is evidence of~     peripherally-maintained central sensitization in children with FAP. The investigators also~     hypothesize that there will be an increase in somatic pain threshold after completion of a~     Cyproheptadine course compared to baseline testing prior to treatment, and compared to~     placebo. This would allow children with FAP to return to normal function, improve symptoms~     and overall general well-being~   "
144588|NCT01674829|"~     To evaluate the safety and tolerability of MA09-hRPE cellular therapy in patients with~     advanced dry AMD To evaluate the safety of the surgical procedures when used to implant~     MA09-hRPE cells To assess the number of hRPE cells to be transplanted in future studies To~     evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of~     MA09-hRPE cellular therapy.~   "
144575|NCT01674998|"~     The purpose of this research study is to determine if safe, simple and non-invasive tests~     such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify~     neurological disorders before typical symptoms occur. Researchers believe that early~     identification of these disorders could lead to treatments to prevent, delay, or slow the~     development of one of more of these diseases. Some people with REM sleep behavior disorder~     (RBD) may go on to develop Parkinson's disease or another related neurological disorder, but~     many do not.~   "
144576|NCT01674985|"~     The purpose of this study is to investigate whether infusion of G-CSF mobilized~     HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine~     chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.~   "
144577|NCT01674972|"~     The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1~     receptor agonists are used for the treatment of T2DM. Insulin resistance is a~     pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect~     in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1~     secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared~     to healthy controls. The results of this study will expand the knowledge of the~     pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.~   "
144578|NCT01674959|"~     Radiation therapy plus concurrent chemotherapy has been demonstrated a significant~     improvement in overall and disease-free survival according to Intergroup Trial 0116 in~     patients with gastric cancer after surgical complete resection. Advantage of application of~     IMRT has been shown in planning comparison studies for postoperative gastric patients. So the~     investigators designed the trial to see safety and efficacy of postoperative concurrent~     chemoradiotherapy of capecitabine combined with IMRT for stage II/II gastric cancer.~   "
144579|NCT01674946|"~     The purpose of this study is do determine the functional significance of the G~     protein-coupled receptor TGR5 in the secretion of GI satiation peptides by using natural bile~     acids and oleanolic acid (triterpenoid compound of plant origin) as TGR5 agonists.~   "
144580|NCT01674933|"~     The study will compare the effectiveness of Duraphat® fluoride varnish in preventing any~     further dental decay among 3-4 year old children in nursery schools.~      It is important to ascertain the additional preventive value that fluoride varnish may~     provide when applied in conjunction with other preventive measures which form part of a~     national dental health improvement programme targeting children at risk from dental decay.~     1600 children will be recruited into the study for 2 years.~   "
144581|NCT01674920|"~     CHOICES is a program to provide children and families with lifetime tools and lifestyle~     strategies to achieve and maintain a healthy body size. Both parents and children get active,~     learn about the food choices they can make, and about the roles of TV in their lives. Led by~     physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences~     that connect into the participants' daily lives. In the study, the families were divided into~     two groups, beginning their classes 6 months apart. Body measurements were taken at baseline~     and every 4 months to 16 months.~   "
144582|NCT01674907|"~     This observational study will evaluate the use in clinical practice and the efficacy of~     Avastin (bevacizumab) in patients with metastatic colorectal cancer who have not received~     prior chemotherapy treatment in the metastatic setting. Patients for whom the treating~     physician has decided to initiate therapy with Avastin will be followed for 10 months.~   "
144583|NCT01674894|"~     This post-marketing, single-center prospective study will be conducted in an open-label,~     non-interventional setting, for women seeking fertility treatment and will describe cleavage~     dynamics in relation to the age of the oocyte and gonadotrophin treatment.~   "
144584|NCT01674881|"~     A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for~     breast cancer experience negative sequelae in the form of pain following treatment. Chronic~     pain is known to be associated with impaired social and emotional functioning, and thus~     presents a particular concern.~      Mindfulness-based intervention is among the complementary, psychological treatments, which~     cancer patients commonly seek out in relation to the course of their illness. Despite the~     popularity of mindfulness-based intervention among cancer patients, no studies have so far~     investigated the effect of mindfulness-based intervention on chronic pain in breast cancer~     patients. While no studies so far have focused on pain, there is evidence to suggest that~     mindfulness-based intervention is associated with improved psychosocial adaption to cancer.~     Furthermore, non-cancer research suggests that mindfulness-based intervention is associated~     with reduced pain experiences.~      The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy~     (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment~     for breast cancer and who experience chronic pain, will be randomized to an intervention~     group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the~     same time points, i.e. before the intervention (baseline), and three times after the~     intervention/control condition, with the last follow-up 6 months after the intervention. In~     addition, a number of potential moderators and mediators of the outcome will be explored. For~     example, recent studies indicate that adult attachment style may constitute an important~     moderator and/or mediator in the development of pain, and preliminary research has suggested~     that attachment style may moderate the effect of mindfulness-based intervention.~      The results will provide valuable new knowledge about the potential of MBCT as a treatment~     strategy for chronic pain in breast cancer patients, will contribute to the clarification of~     underlying mechanisms in the experience of and coping with pain, which could help the~     development of more effective, individualized interventions.~   "
144585|NCT01674868|"~     This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME~     study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the~     effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American~     sample of post-acute stroke patients. This trial will in addition examine the effect of~     treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial~     attention, as well as post-stroke fatigue and will evaluate the durability of observed~     effects. The results of this pilot trial will be used to develop power estimates for a larger~     trial and to evaluate recruitment and intervention completion rates for subjects in an~     American post-acute environment. There are two additional substudies: the first will use MRI~     to assess structural changes at the beginning and end of the intervention; the second will~     examine the relationship of serum biomarkers of inflammation to the intervention.~   "
144586|NCT01674855|"~     This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily~     G-CSF in chemotherapy-induced neutropenia.~   "
144587|NCT01674842|"~     This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients~     with ER negative, PR negative and HER2 negative breast cancer who have undergone~     breast-conserving surgery or mastectomy.~      Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of~     cisplatin when given concurrently with radiation therapy for participants with Stage II or~     III breast cancer who have undergone breast conserving surgery or mastectomy~   "
144589|NCT01674816|"~     Problem:~      Currently, no system allows precise kinematic assessment of the knee and accurate guiding of~     orthopedic surgical actions in a minimally invasive fashion. However, such a system would~     prove useful in the clinical setting to improve the quality of surgical interventions at the~     knee.~      Hypothesis:~      A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging~     and minimally invasive bony fixation allows precise kinematic assessment and surgical~     guidance in the routine clinical setting.~      Objectives :~        -  Demonstrating the capacity of the system to precisely measure 3D knee kinematics~        -  Quantifying the reproducibility of the kinematic measurements~        -  Measuring the impact of knee surgical procedures on knee kinematics~        -  Assessing the correlations between measured articular kinematics and clinical results~          after knee surgery~        -  Integrating the novel measuring system to the surgical flow of three knee surgical~          procedures~        -  Quantifying the precision and reproducibility of the surgical actions guided by the~          system~        -  Comparing the clinical results of surgeries guided by the system to those performed with~          the traditional technique~   "
144590|NCT01674803|"~     The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has~     led to a significant reduction in morbidity. However, the first generation of these devices~     had no positive impact on the mortality after PCI (compared to bare metal stents), which was~     greatly attributed to a somewhat increased incidence of late and very late stent thrombosis.~     Concerns about the role of durable polymers as a potential trigger of inflammation and~     finally adverse events also led to the development of DES with biodegradable coatings, which~     leave after degradation of the coating only a bare metal stent in the vessel wall that does~     not induce an inflammatory response. While such biodegradable polymer DES are increasingly~     used in clinical practice, there is no data available from head-to-head comparisons between~     biodegradable and contemporary third generation durable polymer DES.~   "
144591|NCT01674790|"~     The objective of the 'Exploring potential synergistic effects of aerobic exercise and~     cognitive training on cognition after stroke' pilot trial is to investigate the combined~     effects of aerobic and cognitive training on cognition after stroke. This is to lay the~     groundwork for a larger RCT on the same topic. Twenty patients greater than 6 months~     post-stroke will be randomly assigned into one of four following treatment groups: (i)~     aerobic training (AEROBIC group), (ii) cognitive training (COGNITIVE group), (iii) aerobic~     exercise plus cognitive training (AEROBIC+COGNITIVE group); and (iv) non-aerobic range of~     motion (ROM) and unstructured mental activity (CONTROL group) (for group descriptions, please~     see detailed description below). We hypothesize that the combination of aerobic exercise and~     cognitive training will be more effective in improving cognition after stroke than either~     treatment on its own.~   "
144592|NCT01674777|"~     This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics~     and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male~     subjects.~   "
144593|NCT01674764|"~     Despite many years of research, an incomprehensible amount of scientific efforts worldwide~     and billions of dollars invested, no effective therapy resulting in major neurological or~     functional recovery is available to date for traumatic spinal cord injury (tSCI). Although~     there is increasing experimental evidence from animal models that surgical decompression of~     the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data~     yet. The main explanations for this lack of convincing evidence are relatively small sample~     sizes in previous studies, their predominantly retrospective nature, suboptimal measurement~     methods for the assessment of neurological deficits, and inappropriate recording and~     documentation of potential confounding factors.~   "
144594|NCT01674751|"~     This pilot study will test the feasibility and potential effectiveness of a novel approach to~     improve food choices by employees about what to eat for lunch. The intervention involves the~     testing of an on-line pre-ordering food program with nutritional information linked to a~     hospital cafeteria. In this study, the investigators use positive reinforcement of feedback~     and price discounts during the intervention phase, and then withdraw those components in~     order to assess the potential for changes to be retained after the study is over.~      The study draws on principles from the field of behavioral economics and behavioral change.~     The investigators test the effectiveness of the intervention with 30 employees (study~     participants) who are overweight or obese. Based on a recent screening of over 5600 Einstein~     employees, 66% of those screened were identified as either overweight or obese. There are 3~     phases to the trial: baseline (P1), 4 week intervention, (P2) and tapering (intervention~     without reinforcement) (P3). Participants are randomized to one of two groups (intervention~     and wait-listed controls).~      Our primary hypotheses are that:~        1. Participants will purchase lunches with fewer calories during the intervention compared~          to baseline.~        2. Participants will purchases lunches with fewer calories in the tapering phase compared~          to baseline.~      Secondary hypotheses include that, compared with baseline, participants will order lunches~     with less fat. Changes in participant weight based on self selected goals, and in a measure~     of mindful eating will also be investigated. The investigators expect that participant~     adherence will be associated with improved outcomes compared to those who are less adherent.~   "
144595|NCT01674738|"~     This study wants to determine the activity of a first-line treatment related to Thymidylate~     Synthetase (TS) Expression. Patients with the diagnosis of non-squamous advanced~     Non-Small-Cell Lung-Cancer (Stage IV) and without evidence of EGFR mutation may be enclosed~     in this clinical trial.~   "
144596|NCT01674725|"~     The purpose of this study is to evaluate the safety and antiviral activity of~     ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267~     also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin~     (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without~     cirrhosis.~   "
144607|NCT01674582|"~     The main purposes with this trial is to investigate the potential of MRI with diffusion and~     blood volume, flow in brain to diagnose and to measure treatment effects in patients with~     intracranial tumors, especially gliomas and metastases in a prospective trial, to evaluate~     the possibilities to individually adjusted treatment in this category of patients depending~     on treatment outcomes measured by MRI, to perform clinical follow up in connection with MRI~     to evaluate a correlation and to perform testing of cognitive ability before, during, and~     after treatment and to investigate if given treatment causes any decrease in the patients~     habitual state.~   "
144597|NCT01674712|"~     This is a double-blind, randomized study designed to compare the efficacy and safety of two~     fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin~     145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the~     blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat~     in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has~     been marketed in more than 80 countries since 1975. Simvastatin is also used for the~     treatment of patients with a high level of cholesterol. These have also been marketed~     worldwide for more than 20 years. It is important to treat high levels of fats in the blood~     because it has been shown that even mildly elevated level of lipids in the blood can lead to~     diseases of the blood vessels. It has been shown in several studies and in clinical practice~     that the combination of fenofibrate plus simvastatin can lead to improved effects on blood~     fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the~     study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin~     145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing~     high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in~     reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.~   "
144598|NCT01674699|"~     The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether~     safety and outcomes of the device use in the commercial setting are comparable to the safety~     and outcomes of the device use in the IDE study.~   "
144599|NCT01674686|"~     The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin~     receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients~     with variant angina.~   "
144600|NCT01674673|"~     It is known that the treatment of panic disorder with medication and psychotherapy are both~     effective. Representative as a treatment for panic disorder, Selective serotonin reuptake~     inhibitors (SSRIs) are recommended as first-line treatment of panic disorder. In general, the~     initial reaction rate of panic disorder medication known to be frequently stopped early~     recurrence 70-80% It's too early, it is recommended that the duration of drug treatment for~     at least one year to be long-lasting. But whether it is appropriate for the duration of drug~     treatment to maintain a certain extent remains controversial, and maintain the medication for~     more than one year, even if the long-term effects known to be approximately 50% less than~     beyond being negative when remission based. Meanwhile, the typical method for the treatment~     of panic disorder psychology, cognitive behavioral therapy (Cognitive behavioral therapy) and~     looked comparable to the effect of the drug in the treatment of the known, especially in~     recent years when the combined treatment with medication can increase the long-term treatment~     of sexual reported that there's has been the subject of attention.~      But prospectively compare the long-term effects of these two treatments, research, especially~     the research about the long-term effects of the combined treatment with the drug treatment of~     panic disorder is very low, and almost nil is Researchers, drug treatment and the effect of~     the combined treatment in patients with panic disorder over two years prospective study to~     compare the plans were. And verification, the researchers performed only through this study~     by comparing the long-term effects of the combined treatment with medication combined~     treatment of medication to be more effective than if the reaction to the long-term treatment~     of panic disorder that can affect the clinical and biological factors navigate to evaluate~     them. In addition, long-term observational study, panic disorder patients' subjective quality~     of life actually improved to some extent on the map together proven to.~   "
144601|NCT01674660|"~     The purpose of this study is to explore the factors associated with interdialytic blood~     pressure variability in maintenance hemodialysis patients, especially the association between~     volume status and blood pressure variability.~   "
144602|NCT01674647|"~     A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo~     cardioversion (procedure to restore normal heart rhythm). The study will compare patients~     assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA).~     The study will measure common medical outcomes for this type of patient such as bleeding and~     stroke.~   "
144603|NCT01674634|"~     The primary objective of this study is to assess the safety of two concurrent injections of~     AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable~     cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of~     occurrence of targeted serious adverse events (tendon rupture/ligament injury and~     anaphylaxis) to historical rates of the same in clinical studies and post-marketing~     commercial use.~      The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.~   "
144604|NCT01674621|"~     To determine the clinical safety and efficacy of BA058 Transdermal in otherwise healthy~     postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD)~     and serum markers of bone metabolism when compared to Transdermal Placebo and BA058 Injection~     for 6 months of treatment.~   "
144605|NCT01674608|"~     Patients in the Intensive Care Unit (ICU) traditionally receive bed rest as part of their~     care. They develop muscle weakness even after only a few days of mechanical ventilation that~     may prolong their time in ICU and in hospital, but the nature of such weakness is poorly~     understood.~      The weakness that develops in ICU is more substantial than that which would result from bed~     rest alone and is referred to as ICU acquired weakness (ICUAW). This weakness might be due to~     the combination of inflammation and immobility. The exact mechanisms leading to the nerve and~     muscle damage which occurs in critical illness are not yet fully understood and require~     further investigation. However, it is known that ICUAW has an effect on a patient's ability~     to breathe without a ventilator, walk and perform simple activities (like washing and~     toileting) and often results in longer mechanical ventilation time and hence, longer hospital~     stays than might otherwise be expected. It may also affect a patient's ability to return home~     after their hospital stay. The recovery period in Australian and New Zealand ICU patients is~     unknown but a trial from Canada has reported ongoing weakness five years after leaving ICU.~     Weakness in survivors of intensive care is known to be a substantial problem. It is currently~     not known whether ICUAW may be avoided or its severity reduced with simple strategies of~     early exercise in ICU.~      There are no data about the level of activity and mobility in critically ill patients in~     Australian and New Zealand ICUs. These data are urgently required to plan a program of~     research to test whether increasing the level of mobility and activity in our critically ill~     patients is safe, feasible and efficacious in terms of reducing the severity of ICUAW and~     improving patient-centred outcomes. The program of research will first include a study to~     observe the mobility levels in 25 ICUs across Australia and New Zealand to determine safety,~     barriers to mobility and what type of activities are undertaken by our patients.~      From the observational data we plan to develop a pilot randomised controlled trial of early~     mobility and activity in intensive care units across Australia and New Zealand. This simple,~     cost-effective strategy may improve functional ability, decrease time on mechanical~     ventilation and improve long term outcomes in this patient group. By initiating such a~     program, ANZ investigators might be able to change future patient outcomes worldwide.~   "
144606|NCT01674595|"~     This trial is an open, national, multi-centre trial. The trial will be initiated after olive~     pollen season 2012 and subjects will receive treatment for 6 weeks.~      The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The~     frequency of patients with adverse reactions will be the primary endpoint.~      Frequency of patients with systemic reactions according to EAACI classification, increase in~     IgG4 and in IgE and reduction in immediate skin reactivity.~   "
144608|NCT01674569|"~     The objective of this study is to evaluate the safety and preliminary biologic~     activity/efficacy of X-82 in patients with wet Age-related Macular Degeneration (AMD).~     Preliminary efficacy will be assessed by change from baseline in visual acuity, fluorescein~     leakage, retinal thickness and fibrosis, if detectable, based on fundus examination, fundus~     photography, fluorescein angiography and optical coherence tomography (OCT).~   "
144609|NCT01674556|"~     The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable~     tumours~      The specific sub-objectives of the studies are:~        -  To quantify tumour sizes and relate it to the patient survival over time, dependent of~          treatment method.~        -  To evaluate and compare the toxic effects and safety of gemcitabine in combination with~          US contrast agent under sonication with gemcitabine alone.~        -  Develop and validate new ultrasound perfusion algorithms based on burst- replenishment~          for diagnosis and monitoring of therapy.~        -  To quantify gemcitabine and its main metabolites in plasma and in circulating~          mononuclear cells before, during and after pancreatic sonication, and to quantify the~          concentration of intracellular endogenous nucleotides in circulating mononuclear cells~          at the same time points.~        -  To assess plasma and tissue concentrations of gemcitabine, its main metabolites and~          endogenous nucleotides in those patients where surgical resection can be performed on~          standard clinical indications.~   "
144610|NCT01674543|"~     Schizophrenia is a severe mental illness, of psychosis being the most prevalent in society,~     affecting 1% of the population. The treatment of schizophrenia is basically done with~     antipsychotic drugs, although other non-pharmacological interventions, such as exercise, a~     form of treatment seems to be considered. Among the most recommended exercise for the general~     population, the investigators highlight the aerobic and resistance exercises. However, few~     studies have reported the positive effect of aerobic exercise in the pathogenesis of~     schizophrenia. In relation to resistance exercise and concurrent training, it is unknown if~     the effect in patients with the disease, especially when one considers the junction of the~     two types of exercises in the same training session (called concurrent training). However, it~     is known, through clinical studies and animal models, that exercise modifies the brain~     improves neuroplasticity, the mental condition of the individual frames and reverses~     neurodegeneration. Associated with improvement in schizophrenia, few clinical trials of~     aerobic exercise showed improvement in disease symptoms, reducing anxiety and depression, and~     clinical global improvement. The hypothesis is that the types of proposed training,~     resistance training and concurrent training can improve clinical symptoms of the disease, and~     improve the side effects caused by drugs. It is believed that the clinical changes are~     accompanied by increased serum IGF-1 by resistance training and aerobic training by BDNF.~   "
144611|NCT01674530|"~     The objective of this study is to evaluate the clinical equivalence and safety of the test~     formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd~     compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo~     Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation~   "
144612|NCT01674517|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
144613|NCT01674504|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
144614|NCT01674491|"~     Black soy peptides have been shown to possess properties that may decrease blood pressure. To~     examine the effects of black soy peptides supplementation on blood pressure and oxidative~     stress in subjects with pre-hypertension or stage I hypertension.~   "
144615|NCT01674478|"~     Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common~     devastating gastrointestinal diseases in premature infants. These infants often need surgical~     intervention to remove the dead bowel and create temporary enterostomies, resulting in short~     bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction~     to digest and absorb nutrients adequately.~      These infants are often nourished primarily with parental nutrition (PN) which can lead to~     many complications including PN-associated liver disease. However, with enteral feeding, the~     remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral~     fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty~     acids (LCPUFA) being the most beneficial in promoting bowel adaptation.~      Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation.~     Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and~     increase weight gain in some SBS infants. WThe investigators will soon have completed a~     randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled Early~     Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with~     Enterostomies. The preliminary data suggest that (a) by supplementing enteral ML/FO, we were~     able to decrease the use of IL; (b) premature infants in the treatment group who received~     ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and~     better weight gain (g/day) after reanastomosis than those who received routine care in~     control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in~     the treatment group than the control group although the difference was not statistically~     significant. Because the intervention consisted of both an increase in enteral fat intake as~     well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in~     the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat~     intake. Therefore, the investigators have designed a next randomized clinical trial to~     compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO~     will result in decreased systemic inflammation, as indicated by blood levels of~     inflammation-related proteins and indicators of oxidative stress.~   "
144616|NCT01674465|"~     Calcineurin Inhibitors (CNI) are drugs used to suppress the immune system when a person has a~     solid organ transplant. Although these drugs keep the transplanted organ from being rejected~     they are toxic to kidneys, or nephrotoxic. CNIs cause damage, called fibrosis, to kidneys.~      Fibrosis is a type of scarring that occurs in kidney tissue. Fibrosis can eventually lead to~     kidney failure. One of the pathways that cause fibrosis is a chronic lack of oxygen to the~     kidney tissue called hypoxia. There is a protein called Nox2 that may be involved in how~     this hypoxia happens in the kidney. The Department of Medicine-Nephrology at the University~     of Wisconsin is conducting a research study to see how much of the Nox2 protein is present in~     kidneys that may have fibrosis caused by CNIs and whether a certain type of Magnetic~     Resonance Imaging (MRI) can be used to tell in advance if the disease caused by CNIs is~     getting worse. Study hypothesis: MRI, a non-invasive technique, can be used to determine~     whether CNI induced kidney disease is getting worse. Additionally, the study aims to~     determine the role of Nox2 in CNI nephrotoxicity.~   "
144617|NCT01674452|"~     The aim of this study is the development and the implementation of a new protocol about~     home-based exercises, supported by an illustrated manual, for the treatment of individuals~     with stroke.~      The hypothesis is that this group of patients who are going to carry out the training of this~     study protocol are going to show improvement in measured parameters (functionality and~     physical performance), which allows this protocol to be improved and published as a proposal~     of physiotherapeutic treatment.~   "
144654|NCT01673958|"~     The aim of the present project is to compare the acute and chronic effect of stair descending~     versus stair ascending exercise on muscle damage and performance in elderly males with~     chronic heart failure.~   "
144618|NCT01674439|"~     Although first reports of the clinical use of adipose-derived regenerative cells (ADRC)~     suggest that this approach may be feasible and effective for soft tissue augmentation, there~     is a lack of randomized, controlled clinical trials in the literature. Hence, this study~     aimed to investigate whether a novel protocol for isolation of ADRC and their use in~     combination with fat tissue improve the long-term retention of the grafts in patients with~     craniofacial microsomia.~   "
144619|NCT01674426|"~     This is a randomized pilot study of the use of cognitive behavior therapy versus observation~     to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.~   "
144620|NCT01674413|"~     This is a study that invites adults with Crohn's disease and have been responding well to~     Adalimumab (Humira ®) for at least 6 months. Patients frequently discontinue maintenance~     medications in Crohn's disease, particularly when in remission. Patients want to know that~     they truly need to take a medication, yet they don't want to have flares. The purpose of this~     study is to see that if we monitor the patient, along with looking at changes in their stool~     samples, we can safely stop the maintenance medication Adalimumab for up to 48 weeks, or add~     as-needed dosing only, and keep them in remission.~   "
144621|NCT01674387|"~     Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy~     on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical~     basis for the chronic neck pain treatment and evaluation of efficacy.~   "
144622|NCT01674374|"~     The purpose of this study is to find out what effects (good and bad) SAMITAL (Vaccinium~     myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules) has on~     the management of mucositis (inflammation and ulceration that occurs in the mouth) brought on~     by chemotherapy and radiation therapy for squamous cell carcinoma of the head and neck~   "
144623|NCT01674361|"~     This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with~     obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin~     30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their~     background therapy with an SSRI. Participants will be allocated to one of two strata.~     Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will~     receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2~     visit. Participants in both strata will receive the study drug in addition to their~     background therapy with an SSRI until Week 16.~   "
144624|NCT01674348|"~     It is a phase II, randomized, double-blind, placebo-controlled study of P2202 in patients of~     type 2 diabetes mellitus, inadequately controlled with a stable dose of metformin or~     sulfonylurea or both.~   "
144625|NCT01674335|"~     Activity pacing (AP) is a commonly used treatment for people with chronic pain. Many people~     with pain try to continue their daily activities at the same level as they were able to~     manage before they had pain. This way of coping causes increases in their pain; they become~     discouraged and give up on their activities. AP treatments involve helping them regulate~     their activity level so that they can achieve important life goals. Although AP is widely~     used, its effectiveness is still unproven. There are two key approaches: The operant learning~     (OL) approach uses quotas related to time or goals the person sets. The energy conservation~     (EC) approach focuses on balancing patient energy expenditure. Both of these treatments have~     often been used with people with Fibromyalgia Syndrome (FMS), a common pain condition. We~     will examine the effects of these treatments on pain, fatigue, quality of life, physical~     functioning and mental well-being. We will also investigate whether other factors influence~     treatment effectiveness (e.g., a person's readiness to change, pain intensity level). 120 FMS~     patients will be randomly assigned to receive OL, EC, Delayed-OL or Delayed-EC. Data will be~     collected at baseline, at the end of treatment and at 3, 6 and 12 month follow-ups. FMS~     patients will be recruited consecutively from Rheumatologists at St. Joseph's Health Care~     London. OL and EC treatment manuals will be developed by experts in the field and both~     interventions will be given by two occupational therapists over a 3 month period as~     stand-alone interventions (10 sessions of 120 min). All sessions will be recorded in order~     to assess intervention fidelity. This study will be the first to base AP interventions on a~     clearly delineated theoretical framework. It will clarify whether AP strategies benefit~     individuals with FMS and whether either of these two approaches is more effective. Our~     results will help to direct clinical resources and funding toward the most beneficial~     interventions.~   "
144626|NCT01674322|"~     The purpose of this study is to investigate the absorption, the metabolic pathways and the~     excretion of ibrutinib in healthy male adult participants after administration of a single~     oral dose of 50 mg to 140 mg (5 mg/mL solution) of unlabeled ibrutinib admixed with 14C~     ibrutinib.~   "
144627|NCT01674309|"~     The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer,~     with an objective response rate of about 70 %. This phase II is to investigate if this~     systematic attack chemotherapy could control at the same time the rectal tumor and the~     synchronous metastasis without compromising secondarily the tumor or the metastasis resection~     or a radiochemotherapy administration.~        1. The main objective of the trial is to investigate the tumoral control rate at 4 months,~          according to the RECIST criteria (version 1.1).~        2. The secondary objectives are:~             -  safety of the treament,~             -  rate of local failure and local complication (occlusion, important bleedings,~               resistant pains with morphinic treatment, perforation),~             -  survival without local failure (radiological or clinical progression of the rectal~               cancer or local complication),~             -  rectal tumor response rate (CT scan, MRI and endocopy),~             -  metastasis response rate,~             -  disease free survival after complete resection (of primitive tumor and metastases),~             -  progression free survival (local or distal),~             -  overall survival, quality of life (QLQ-C30 + CR 29).~   "
144628|NCT01674296|"~     The purpose of this study is to develop a better understanding of factors affecting~     American's energy balance related behaviors - in this case, food intake and activity. In the~     present study we will describe the relative contributions of individual psychology and~     physiology (including metabolism, mood, and sleep habits) and external (season, stressors)~     contributions to changes in adiposity over a year in free-living individuals.~      This study will illuminate season's role in changes in energy balance related behaviors and~     body weight and composition. Ultimately, this information will be used to identify factors~     affecting food consumption and individual activity during seasonal periods to help to segment~     interventions for obesity prevention in mid-life women.~   "
144649|NCT01674023|"~     MicroRNAs are important regulators of many cellular functions but their expression profile in~     human vitreous is still unclear. Aim of this study is to investigate microRNA expression~     profile by PCR in human vitreous of patients with various vitreoretinal disorders and compare~     with that of patients with macular holes which are suggested to be similar to that of healthy~     subjects.~   "
144629|NCT01674283|"~     The success of in vitro fertilization is based mainly on uterine implantation embryo. An~     excessive uterine contractility may interfere with implantation by a movement of the embryo~     in the uterus. The inhibition of the uterine contractility may have a positive effect on~     success rate of in vitro fertilization. It is through parenteral injection of glucagon and~     its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the~     time of embryo transfer, the investigators intend to improve the pregnancy rates obtained~     after IVF.~   "
144630|NCT01674270|"~     To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on~     intratumoral levels of androgens.~   "
144631|NCT01674257|"~     Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks~     and strokes. PET CT and contrast-enhanced MRI scans are two new ways of assessing~     atherosclerosis. The investigators propose to perform PET CT and MRI scans on patients with~     hardening of the neck arteries due to undergo surgery to remove the hardened areas. The~     investigators will then be able to compare the hot spots found on these scans with what the~     investigators can see in the removed specimens under the microscope in the laboratory. This~     will give investigators insight into the value of PET CT and MRI as tools for assessing~     atherosclerosis. It will also provide the investigators with new information relating to the~     underlying processes that give rise to atherosclerosis and will pave the way for the future~     development of new treatments.~   "
144632|NCT01674244|"~     Despite the considerable efforts of the DoD and VA to improve awareness of mental health~     problems and access to care, many returning veterans still report substantial barriers to~     seeking traditional mental health care. Research suggests that a significant barrier to~     pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of~     this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the~     utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise~     and mindful breath training) in addressing global post-traumatic stress disorder (PTSD)~     symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD.~     Specifically, this study will examine whether a 12-week course of Integrative Exercise~     therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD~     symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves~     other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological~     distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist~     condition) and 3) whether such treatment is feasible and acceptable.~      A secondary aim of this study is to evaluate possible mechanisms underlying these effects~     such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic~     capacity, and improved sleep.~   "
144633|NCT01674231|"~     The investigators hope to learn about the effects of whole grapes, in the form of~     freeze-dried grape powder, on markers of health. Phytochemical rich food consumption is~     associated with protection against chronic diseases such as cardiovascular disease (CVD)~     demonstrating the ability to modify endothelial function and lipemia, but exact causal~     mechanisms are still not well understood. The investigators will examine metabolic and~     mechanistic effects of consumption of whole grape powder in chronic as well as acute settings~     in response to meal challenges by testing blood samples to determine if markers of health~     have improved.~      The central hypothesis of this project is that consumption of grapes in the form of a~     polyphenol-rich freeze-dried whole grape powder (WGP) will attenuate chronic and meal induced~     oxidative stress and inflammatory responses in obese individuals.~   "
144634|NCT01674218|"~     This is a Phase I, single-center, double-blinded, randomized, placebo-controlled, five-period~     cross-over clinical study of PA-824 to evaluate the effect of PA-824 and of PA-824 plus~     moxifloxacin on cardiac repolarization (QT/QTc interval duration) in a total of 75 healthy~     male and female participants, aged 18 to 45 years. Moxifloxacin will be used as an active~     control. Participants will be blinded to the treatments they will receive. The study consists~     of a screening period up to 26 days; enrollment, 1 day; five in-patient treatment periods~     consisting of an admission day (except in the first treatment period, when the pre-dose day~     is the baseline), dosing day and two post-dosing days; an out-patient period of at least~     three days and not more than 10 days between treatment periods; and a final visit 7 - 14 days~     after discharge from the last treatment period.~   "
144635|NCT01674205|"~     This study seeks to understand the host factors that affect the replication and immune~     response of seasonal and candidate pandemic live attenuated influenza vaccine (LAIV) in~     humans and to develop biomarkers that can predict the viral shedding and immune response to~     LAIVs.~   "
144636|NCT01674192|"~     The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of~     prucalopride in subjects with various degrees of renal impairment compared with normal renal~     function and to monitor the safety profile of prucalopride in subjects with renal impairment.~      Hypothesis:~      Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally~     impaired subjects compared with the normal population.~   "
144637|NCT01674179|"~     The purpose of this study is to retrospectively analyze Clinical and Nocturnal~     Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia.~      Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent~     awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during~     routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha~     intrusions may be an objective marker for Fibromyalgia and may correlate with current~     clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia.~   "
144638|NCT01674166|"~     The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03~     mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal~     retention.~      Hypothesis:~      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the~     adult pharmacokinetic profile~   "
144650|NCT01674010|"~     The primary purpose of this study is to determine whether ELND005 is effective in the~     maintenance treatment of bipolar 1 disorder when added to other therapies.~   "
144651|NCT01673997|"~     The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol~     Succinate Extended-Release Tablets 200 mg under fasting conditions~   "
144639|NCT01674153|"~     Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims~     of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of~     dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it~     is suggested that exercise increases the cardiac output, thus increases the blood flow to~     lower extremities. This leads to increased toxin removal from low blood flow regions. On the~     other hand, exercise can possibly dilate the vasculature and decrease the compartmental~     resistance. In this study, the investigators aim to investigate the exercise induced~     physiological changes which enhances the toxin removal. This information combined with~     patient specific mathematical models will encourage clinicians to opt for Optimal~     intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted~     renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin~     removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional~     hemodialysis.~   "
144640|NCT01674140|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or~     exemestane, may fight breast cancer by lowering the amount of estrogen the body makes.~     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It is not yet know whether hormone therapy is more effective when given with or~     without everolimus in treating breast cancer.~      PURPOSE: This randomized phase III trial studies how well giving hormone therapy together~     with or without everolimus work in treating patients with breast cancer.~   "
144641|NCT01674127|"~     The present study examined the effects of Methyldopa on uterine artery diameter, uterine~     artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with~     Preeclampsia, using Doppler ultrasound.~   "
144642|NCT01674114|"~     The purpose of this study is to investigate whether a regional-block (TAP block) in Caesarean~     section will give a measurable benefit in form of reducing Morphine consumption as compared~     to local infiltration of the wound with local anesthetic.~   "
144643|NCT01674101|"~     This application proposes a prospective clinical trial to evaluate the impact of adding a~     focused physical therapy (PT) intervention to the preoperative regimen of individuals~     diagnosed with a malignancy of the lower extremity (LE). The primary aim will be to determine~     if individuals diagnosed with a malignancy of the LE can participate in a 10 week~     preoperative strengthening, stretching, and aerobic exercise regimen.~   "
144644|NCT01674088|"~     Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US~     population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of~     the disease still remains unclear. It has been hypothesized that patients with IBS have~     alterations in the intestinal lining leading to release of toxic substances into the blood,~     commonly referred to as leaky gut. Current methods used to study leaky gut are both expensive~     and invasive. The investigators will test a new breath test to measure leaky gut in both IBS~     patients and subjects without IBS symptoms.~   "
144645|NCT01674075|"~     The J-Tip device (National Medical Products, Irvine, CA, USA) is a single-use, needle-free~     anesthesia delivery system, approximately 10cm long and weighing 9g that allow for the rapid~     delivery of lidocaine hydrochloride prior to peripheral venous access procedures. First~     introduced in 2001, it uses compressed carbon dioxide for drug delivery into the subcutaneous~     space. J-Tip is now approved by the U.S. Food and Drug Administration (FDA) for both children~     and adults.~      Designed for patients with needle anxiety and phobia, several clinical trials (Hollingsworth~     et al, 2000; Cooper JA et al, 2000) have shown the device to be effective with no significant~     untoward effects, including in children as young as 3 years old (Zempsky et al, 2008).~     However, two recent cases of toxic serum lidocaine levels in pediatric patients at~     Massachusetts General Hospital (MGH) following the use of the J-Tip device is concerning.~     Both patients were administered local anesthetic using the J-Tip device prior to needle-stick~     and toxicity screens returned with high levels of lidocaine (>6000 mcg/L).~      Currently, there is a limited amount of literature available on the safety profile of the~     J-Tip Delivery System and no study to date has evaluated serum lidocaine levels following its~     use, likely on the assumption that systemic absorption from the small amount of lidocaine~     within the device should be negligible. The two pediatric cases highlighted above, seem to~     suggest otherwise. The purpose of this pilot study is to assess the safety of the J-Tip~     device on a small population of healthy adults and to determine if elevated lidocaine levels~     are present systemically or locally. The primary outcome will be lidocaine serum levels~     following the administration of the J-Tip device measured at the local site and two distal~     sites to establish lidocaine serum levels following J-Tip administration. We expect lidocaine~     levels to be undetectable.~   "
144646|NCT01674062|"~     This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with~     Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on~     trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the~     efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and~     clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840~     milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab~     will be administered at the same schedule the participant was following before entry into the~     study. An additional cohort of participants at certain centers will receive pertuzumab~     monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks.~     These participants may have trastuzumab added to the regimen in the event of progression~     during single-agent pertuzumab treatment.~   "
144647|NCT01674049|"~     The purpose of the proposed study is to examine the timing of post-exercise feeding on 15~     hours post-exercise glycemic control and metabolic flexibility and in overweight and obese~     young men with a family history of type 2 diabetes.~      Aim 1 - To determine the temporal effects of post-exercise feeding (i.e., immediate~     post-exercise vs. 3 hours post-exercise) on glycemic control, peripheral insulin sensitivity,~     and metabolic flexibility (as evaluated by sleep RQ) in this same group of participants. We~     hypothesize that a 3 hour delay in nutrient ingestion will promote significantly greater~     improvements in glucose tolerance, metabolic flexibility, and peripheral insulin sensitivity~     both immediately and several hours post-ingestion.~   "
144648|NCT01674036|"~     The objectives of this study are to assess the tolerability, safety and pharmacokinetic~     parameters of Genz-682452 in healthy adult males, in two parts.~      Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential~     ascending single dose study;~      Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment~     crossover study with a minimum wash-out period; to obtain preliminary information on the~     pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and~     fasted conditions.~      Subjects are not allowed to participate in more than 1 part of the study.~   "
144657|NCT01673919|"~     This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra~     (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who~     completed the WA19977 core study. Patients will continue to receive RoActemra/Actemra 8 mg/kg~     intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.~   "
144658|NCT01673906|"~     The diagnostic work-up of patients suspected of having neuroendocrine tumours (NETs) has~     traditionally been a challenging issue. The last two decades have been marked by the~     application to use in the diagnosis of NETs of 3 newly available diagnostic techniques:~     endoscopic ultrasonography (EUS), multidetector CT (MDCT), and more recently, positron~     emission tomography using 68Ga-labelled octreotide analogues (PET). In a prospective study~     conducted at a single referral centre that compared PET with conventional somatostatin~     receptor scintigraphy and MDCT in diagnosis, staging and follow-up of patients affected by~     NET, PET detected more primary and secondary lesions than other methods. Recent studies~     investigated the clinical impact of PET in the management of patients affected by NET,~     previously studied by MDCT. The investigators recently reported the results of the~     investigation of 19 patients suspected of having primary pancreatic NET and studied by PET,~     MDCT and EUS. The investigators preliminary data suggest that PET may be slightly more~     sensitive than MDCT in detecting small (<2cm) pancreatic lesions; accuracy of PET and EUS is~     probably similar. No prospective study has yet been devoted to evaluate the accuracy of PET~     in the diagnosis and staging of primary duodenal-pancreatic NETs. Furthermore, the clinical~     impact of the adjunct of PET to the traditional protocols of diagnosis and staging of these~     tumours waits to be thoroughly evaluated. Thus the appropriate place of PET in the diagnostic~     algorithm of patients suspected of having duodenal-pancreatic NET remains undefined.~      The main aim of this project is to prospectively compare the accuracy of PET and MDCT in the~     diagnosis and staging of patients suspected of having duodenal-pancreatic NETs. The~     investigators hypothesised that PET is superior to MDCT in the diagnosis of these neoplasm~     (the dimension of the study sample is estimated in order to detect a 10% difference). The~     impact of PET on management plan of affected patients will also be evaluated. As a secondary~     endpoint of the study, the investigators will compare EUS, PET and MDCT in the diagnosis of~     primary duodenal-pancreatic NET. The study is designed as a multicentre, prospective,~     non-randomised clinical trial. All patients will undergo MDCT, PET and EUS in this fixed~     order.~   "
144659|NCT01673893|"~     The purpose of this registry is to determine if delivery of weight adjusted, in a large dose~     with either Abcixmab or Eptifibitide through the ClearWay™ RX, in patients admitted for~     primary coronary intervention lowers readmission rate. This is done in comparison to the~     historical control of the Medicare/Medicaid readmission database. The registry will record~     the use of the product during the index procedure, and determine whether or not the patient~     was readmitted within 30 days, related to the index procedure.~   "
144660|NCT01673880|"~     This is a single-center, open-label, randomized crossover study being conducted in three~     cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of~     three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose~     of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random~     sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.~   "
144661|NCT01673867|"~     The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as~     compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC)~     after failure of prior platinum-based chemotherapy~   "
144662|NCT01673854|"~     The purpose of this study is to assess the safety profile of vemurafenib, 960 mg,~     administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600~     mutated advanced/metastatic melanoma.~   "
144663|NCT01673841|"~     In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with~     relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that~     previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might~     be related to time delay issues and to the measurement technology.~      42 consenting patients undergoing elective off-pump coronary artery bypass grafting were~     included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead~     for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed~     just above the eyebrows, and the sensors of the other monitor were placed just above the~     former sensors. The sensors placement was determined at random by a computerized~     randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All~     variables were recorded continuously. The study ended at the end of the operation.~   "
144664|NCT01673828|"~     This study will provide initial data on the safety and effectiveness of allopregnanolone in~     improving neurobehavioral outcome and reducing mortality in adults with moderate and severe~     traumatic brain injury.~   "
144665|NCT01673815|"~     Fundoscopy is an important aspect of the neurological examination, but can be challenging in~     uncooperative children. This study explored whether viewing a video (selected by patient or~     caregiver) during eye examination improves the success, duration and ease of pediatric~     fundoscopy.~      Hypothesis: Showing a short video clip during a fundoscopic exam will increase the~     probability of successfully visualizing the optic disk and reduce the amount of time needed~     to perform a fundoscopic exam in children between 1-8 years old.~   "
144666|NCT01673802|"~     The purpose of this project is to evaluate the role of gadoxetate (Eovist®) enhanced~     dual-energy CT in better evaluating perihilar cholangiocarcinoma. This pilot project aims to~     address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher~     resolution delineation of these often infiltrative tumors on single-source, Dual-Energy~     Spectral Multi Detector CT (MDCT), capitalizing on improved spatial resolution achievable~     with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to~     aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the~     hilar variety.~   "
144667|NCT01673789|"~     Alopecia Areata (AA) is one of the most common T cell-mediated autoimmune diseases, leading~     to the chronic and relapsing hair loss. The prevalence of AA worldwide is 0.1 to 0.2%,~     affecting an estimated 5.3 million people in the United States. To date, the clinical~     therapies are limited and disappointed for the treatment of AA. Alternative approaches are~     needed. Increasing evidence demonstrates that stem cells possess the function of immune~     modulation. We established the Stem Cell Educator therapy by using cord blood-derived~     multipotent stem cells (CB-SCs)(Zhao Y, et al. BMC Medicine 2012). A closed-loop system that~     circulates a patient's blood through a blood cell separator, briefly co-cultures the~     patient's lymphocytes with adherent CB-SCs in vitro, and returns the educated lymphocytes~     (but not the CB-SCs) to the patient's circulation. Our clinical trial reveals that a single~     treatment with the Stem Cell Educator provides lasting reversal of autoimmunity that allows~     regeneration of islet beta cells and improvement of metabolic control in subjects with~     long-standing type 1 diabetes (T1D), which is another most common T cell-mediated autoimmune~     disorder in the United States. Here, we develop and explore the therapeutic effectiveness of~     Stem Cell Educator therapy in AA patients.~   "
144668|NCT01673776|"~     This study is designed to compare the outcome of patients with proximal femoral fractures~     with different perioperative regimes: a group with a multimodal intervention and a control~     group.~   "
144670|NCT01673750|"~     This is an observational study that seeks to gather information about perceptions of body~     image through the use of a one-time questionnaire completed by participants at the time of~     study enrollment.~      Effective management of Human Acquired Immune Deficiency Syndrome (AIDS) caused by the Human~     Immunodeficiency Virus (HIV) has become possible through the use of Highly Active~     Antiretroviral Treatment (HAART). As a result of more successful treatment options, HIV/AIDS~     has transitioned from a terminal illness to one which is treated as a chronic condition. One~     particular group that has been impacted tremendously by HIV in the United States is the~     adolescent population. As youth are living longer with HIV/AIDS, clinicians and researchers~     are beginning to examine ways in which the disease can affect one's physical health, mental~     health, and other psychosocial factors. Research emerging involving adults with HIV/AIDS has~     suggested that increased attention to and negative views of one's body image may be found at~     a higher rate in this group. To our knowledge, very few studies have examined this~     relationship in adolescents with HIV.~   "
144671|NCT01673737|"~     Primary Objective:~      Part A - Monotherapy:~      - To determine the maximum tolerated dose (MTD) of SAR260301 administered as monotherapy and~     either on a once or twice daily schedule, to patients with advanced solid tumors or~     lymphomas.~      Part B - Combination:~      - To determine the maximum tolerated dose (MTD) of SAR260301 administered in combination with~     the recommended standard dosage of vemurafenib to patients with unresectable / metastatic~     v-raf murine sarcoma viral oncogene homolog B1 (BRAF)-mutated melanoma.~      Secondary Objectives:~        -  To characterize the overall safety and tolerability profile of SAR260301 administered as~          monotherapy (Part A) and in combination with vemurafenib (Part B).~        -  To characterize the pharmacokinetic (PK) profile of SAR260301 administered as~          monotherapy (Part A) and in combination with vemurafenib (Part B) as well as vemurafenib~          PK in combination with SAR260301 (Part B)~        -  To evaluate food effect on SAR260301 PK (Part A)~        -  To assess preliminary antitumor activity according to Response Evaluation Criteria in~          Solid Tumors (RECIST 1.1 criteria).~        -  To assess preliminary antitumor activity using volumetric computed tomography (CT) or~          magnetic resonance imaging(MRI)~        -  To evaluate the pharmacodynamic (PD) effects of SAR260301 on blood and tumor.~        -  To evaluate PK/PD relationships.~        -  To identify the recommended phase 2 dose of SAR260301 in combination with vemurafenib~          (RP2D) (Part B only)~        -  To assess potential induction effect of SAR260301 on cytochrome P450 (CYP) isoenzyme 3A~          (CYP3A) (Part A)~   "
144672|NCT01673724|"~     The purpose of this study is to determine whether pramipexole and bromocriptine are effective~     in the treatment of non-motor symptoms in Parkinson's Disease.~   "
144673|NCT01673711|"~     This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk~     for lung cancer. Studying samples of urine in the laboratory from smokers who are at high~     risk for lung cancer may help doctors learn more about biomarkers related to cancer.~   "
144674|NCT01673698|"~     The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific~     evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and~     exercise in the treatment of obese subjects with one or more obesity-related comorbid~     conditions.~   "
144675|NCT01673685|"~     Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to~     improve quality of life and other outcomes for patients with chronic obstructive pulmonary~     disease.~   "
144676|NCT01673672|"~     The purpose of this study is to assess the therapeutic potential and safety/tolerability of~     study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to~     severe allergic asthma not sufficiently controlled on current standard controller therapy.~      Altogether 360 patients randomized to 4 treatment groups will be included. The study compares~     three dose strength with placebo. Each patient receives 7 injections of study drug or~     undistinguishable placebo. Key outcome measures are patient reported parameters on their~     asthma.~   "
144677|NCT01673659|"~     The objectives of this study is to demonstrate bioequivalence (comparable safety and~     efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic~     rhinitis.~   "
144678|NCT01673646|"~     To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in~     Japanese patients with active acromegaly or pituitary gigantism. Primary objective is to~     assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to <~     2.5 µg/L and the normalization of IGF-1 at 3 months of study treatment.~   "
144679|NCT01673633|"~     One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular~     involvement. Mostly involved joints in SSc were reported as wrist,~     carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little~     knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of this~     joint in SSc.~   "
144680|NCT01673620|"~     The purpose of this study is to assess the safety and tolerability of montelukast 10~     mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.~   "
144681|NCT01673607|"~     The immune response at primary tumor has a major role in the prognosis of colorectal cancer~     (CRC). Some studies suggest a prognosis value of cytotoxic T cell and memory T cells at~     primary tumor greater than tumoral stage. There is no work in the literature that has~     examined the prognosis value of the immune response in liver metastases. To study immune~     cells (histology) and inflammatory response (cytokines) in liver metastases is a challenge to~     understand the effectiveness of chemotherapy used in this situation.~      The chemotherapy used in liver metastases of colorectal cancer also have effects on~     non-tumoral liver tumor and therefore can interfere with postoperative complications of~     hepatic resection. Sinusoidal dilatation is present in 20% to 80% of patients who received~     oxaliplatin before hepatectomy. Steatosis is frequently observed after administration of 5-FU~     alone or in combination with irinotecan. This steatosis may also be accompanied by~     inflammatory lesions (steatohepatitis), especially after administration of oxaliplatin or~     irinotecan and is associated with increased postoperative mortality. The hepatic toxicity of~     new biological agents is not well known (cetuximab and bevacizumab). The mechanisms of~     chemotherapy-induced toxicities are currently unknown. The main objective is to analyze the~     profile of the immune response in liver metastases of CRC and find the link with the~     radiological response. Measurements will be made by quantitative RT-PCR on frozen liver~     biopsies. Secondary objective is to seek a correlation between the histological lesions~     induced by chemotherapy and non-invasive tests for liver fibrosis. The secondary endpoints~     are rate of immune cells, histologic response (percentage of tumor necrosis), disease-free~     survival, the non-invasive test of fibrosis, the chemotherapy-induced liver injury, cytokines~     and circulating angiogenic factors.~   "
144695|NCT01673412|"~     This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU)~     characteristics known as possible prognostic markers, and which sociodemographic and~     psychologic factors associated with VLU are associated with complete healing at 24 weeks.~   "
144682|NCT01673594|"~     The purpose of this study is to a) assess the efficacy of naltrexone in preventing~     stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere~     with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether~     naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We~     predict that naltrexone will successfully prevent stimulant-induced euphoria without~     interfering with the ability of stimulants to effectively treat ADHD in adults. This study~     will be an 8 -week trial with young adults (18-24) with ADHD.~   "
144683|NCT01673581|"~     This study will evaluate the usefulness of an informational website designed to educate~     patients with prostate cancer about their options for treatment. The investigators hope that~     this website will assist patients with making informed decisions about their care and~     improving their satisfaction with the treatments they choose.~   "
144684|NCT01673568|"~     Postoperative seroma formation is one of the most common complications after ventral hernia~     repair. Although some seromas may not have clinical impact, postoperative seroma formation~     often causes pain and discomfort and may even compromise wound healing. The use of~     postoperative abdominal binder is often recommended after ventral hernia repair to prevent~     seroma and diminish pain, but still with no scientific evidence. The primary aim of the~     present study is to investigate the effect of postoperative abdominal binders after~     laparoscopic ventral hernia repair on postoperative pain, discomfort and quality of life.~     Secondary, we register seroma formation.~      Method and material Randomized, controlled, multi-center, investigator-blinded study. A~     minimum of 56 patients (2X28 umbi/epi) are included, inclusion number is based on power~     calculations. Patients are randomized either to abdominal binder or no abdominal binder. The~     abdominal binder is worn from immediately after the operation and continuously for 7 days,~     night and day. Outcomes are based on patient self-reported registrations using Visual Analog~     Scales (VAS) and Carolina Comfort Scale (CCS), which is a validated, hernia-specific tool to~     estimate quality of life, pain and discomfort. Patients are followed-up for 30 days. For~     secondary outcome we use ultrasound to measure the volume of seroma formation. We use~     Mann-Witney, non-parametric statistics calculating the seroma formation and Friedmanns test~     for pain, discomfort and quality of life for the effect of time on inter- and intragroup~     differences during the study period. P < 0.05 is considered significant.~   "
144685|NCT01673555|"~     This protocol is designed to explore whether short-term therapy with GSK1278863 affects PASP~     under normoxic and hypoxic conditions in healthy volunteers. Healthy subjects will be~     evaluated using echocardiography to estimate PASP based on the velocity of the tricuspid~     regurgitant jet. Resting PASP will be assessed under normoxic (room air) conditions, as well~     as after 30 minutes' exposure to 15% O2 before, during, and after short-term treatment with~     GSK1278863.~   "
144686|NCT01673542|"~     Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of~     dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the~     puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required~     for a 50% difference with the standard deviation of the control group, a significance level~     of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35~     patients per group.~      The expected benefit is the reduction of pain at the skin puncture during the realization of~     BAX.~      Improving professional practice and quality care~   "
144687|NCT01673529|"~     A two part, randomized, double-blind, placebo controlled study to investigate the effects of~     topical doses of SB705498 in healthy volunteers.~   "
144688|NCT01673516|"~     The purpose of this study is to demonstrate that Renal Sympathetic Denervation (RDN) improves~     the control of blood pressure (BP) in patients with treatment-resistant hypertension, as~     compared to intensive medical therapy (IMT) using hemodynamic parameters and then applying a~     predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) during~     6 months intensive treatment program (receiving antihypertensive care according to the 2007~     ESH Guidelines). Working hypothesis: When it is possible to disrupt the sympatho-renal axis~     by RDN - BP reduction occurs to a greater extent and more rapidly than applying intensive~     medical therapy using IHM.~   "
144689|NCT01673503|"~     The purpose of this study is to compare visual acuity, safety, predictability, corneal~     biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule~     extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after~     ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.~   "
144690|NCT01673490|"~     Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90~     subjects will be enrolled so that among them at least 57 will complete the 6-month treatment~     period and evaluable for analysis.~      -Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination~     therapy for six month in BPH patients by monitoring category, frequency and severity of~     adverse events encountered during the treatment period.~      -Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin~     combination therapy with regard to symptom improvement in BPH patients by monitoring and~     analyzing of changes in IPSS and Qmax after 6 months of treatment.~   "
144691|NCT01673464|"~     The main purpose of this study is to prospectively examine changes in Brain Network~     Activation(BNA)following concussion in high school athletes. In addition, the study will~     examine the relationship between changes in BNA to symptoms, cognitive performance and~     vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high~     school athletes with concussion.~   "
144692|NCT01673451|"~     This is a single-center, randomized, double-blind, placebo-controlled, sequential,~     multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy~     adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening~     dosing).~   "
144693|NCT01673438|"~     This is a phase 1b open-label study to investigate the safety and maximum tolerated dose of~     aldoxorubicin plus doxorubicin HCl adminstered as infusion every 3 weeks for up to 8 cycles~     in subjects with advance solid tumors.~   "
144694|NCT01673425|"~     The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be~     effective in children but less effective in adults. Our hypothesis is that this relative~     failure is due to adults having enough anti-flu IgA antibody in nasal secretions to~     neutralize the weakened vaccine virus.~   "
144697|NCT01673386|"~     This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride~     and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for~     Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score (0~     vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2~     treatment arms. The study consists of two 12-week treatment periods with a 1-week washout in~     between. Subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and~     sunitinib sequentially. The study is designed to compare subject treatment preference, as~     well as overall safety and tolerability, frequency of dose modifications and kidney-specific~     health outcomes/QoL.~   "
144698|NCT01673373|"~     The purpose of this trial is to test how well the iCAST™ RX Stent works in patients diagnosed~     with atherosclerotic renal artery stenosis and whether or not increased blood flow by the~     stent will help to control blood pressure.~   "
144699|NCT01673360|"~     To monitor post-market performance through evaluation of short and long-term performance via:~        -  Efficacy~        -  Safety~        -  Patient reported outcomes~   "
144700|NCT01673347|"~     Using the concept of an implant acting as a spacer and stabilizer, the proposed study will~     evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of~     the great toe.~   "
144701|NCT01673334|"~     We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates~     of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic~     tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield~     than core biopsy.~   "
144702|NCT01673321|"~     This study compared the effects of dairy products, including milk and yogurt, with different~     amounts of proteins on responses of appetite, glucose and insulin and on food intake at a~     meal served 120 minutes later in healthy adult male individuals.~   "
144703|NCT01673308|"~     This is a Phase II study to evaluate the efficacy of second-line lenalidomide monotherapy for~     myelodysplastic syndrome (MDS) patients who failed to hypomethylating agents.~   "
144704|NCT01673295|"~     OBJECTIVE To test whether Rituximab (RTX) is efficacious to achieve complete renal response~     (CR) in Lupus Nephritis (LN) patients with persistent proteinuria (≥1g/d) despite at least 6~     months of standard of care (SOC).~      STUDY DESIGN Investigator-initiated randomized international open multicentric 104-week~     study.~   "
144705|NCT01673282|"~     This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in~     clinical practice and will also evaluate the subsequent change in the drug load of patients~     after addition of VIMPAT® to their treatment regimen.~   "
144706|NCT01673269|"~     When a doctor performs Endoscopic retrograde cholangiopancreatography ERCP (Endoscopy to~     examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The~     tube passes beyond the stomach and into an opening in the liver called the bile duct. Another~     small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile~     duct to ensure that there are no cancers or stones in the bile duct and occasionally to take~     a sample from the bile duct. The purpose of our study is to examine wither performing this~     procedure can transmit bacteria from the bile duct to the main blood stream.~   "
144707|NCT01673256|"~     The objective of this study is to assess the atrial fibrillation (AF) episode detection when~     using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).~   "
144708|NCT01673243|"~     Little is known about what factors influence parental decisions to participate or to decline~     participation in tobacco trials offered in the pediatric clinical setting. Further, it is~     unclear what proportion of parents treated in our setting would elect to receive formal~     assistance with quitting smoking or consider alternative approaches that could facilitate~     eventual smoking cessation. While the recommendation to parents is generally to quit smoking,~     some may be unwilling or unable to quit and prefer more achievable alternative treatment~     goals. Some parent smokers may be unlikely to participate in an intervention aimed only at~     cessation but would be willing to participate in an intervention focused on establishing~     smoke-free environments for their child. Parents are typically not offered a choice regarding~     the type of intervention they receive and many interventions are not tailored to their~     readiness to quit smoking or designed to reach multiple family members in the home who may~     also smoke. Quitting smoking and establishing smoke-free homes and cars are distinct, yet~     challenging, goals for parents and families. Both approaches can directly, or indirectly,~     help parents to quit smoking, reduce the child's exposure to second-hand smoke (SHS), and~     initiate an important dialogue with families about tobacco control. How parental~     acceptability of smoking interventions is affected by the context of their child's treatment~     for cancer or SCD, as well as survivorship, warrants further study.~   "
144709|NCT01673230|"~     Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when~     pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires~     adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices~     of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not~     been showed until now when LVEF is altered.~   "
144710|NCT01673217|"~     This phase I trial is studying the side effects and best dose of decitabine when given~     together with pegylated liposomal doxorubicin hydrochloride and vaccine therapy in treating~     patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal~     cancer. Drugs used in chemotherapy, such as decitabine and pegylated liposomal doxorubicin~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Vaccines made from a peptide or antigen may help~     the body build an effective immune response to kill tumor cells. Giving combination~     chemotherapy together with vaccine therapy may kill more tumor cells~   "
144734|NCT01672905|"~     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the~     laboratory may help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in~     samples from patients treated for prostate cancer on trial ECOG-E9802.~   "
144807|NCT01671956|"~     This is a randomized, double blind, placebo-controlled, parallel group multi-center study in~     adult patients with active moderate to severe UC . Eligible patients will be randomly~     assigned in a 2:1 ratio to one of two treatment groups, bertilimumab 10 mg/kg or matching~     placebo, respectively~   "
144711|NCT01673204|"~     Worldwide, the most common cause of chronic kidney disease (CKD) and end stage renal disease~     (ESRD) is diabetes. Unlike the past, in south korea, diabetes account for more than 40% of~     ESRD. According to WHO reports in 1998, 100 million people had type 2 diabetes in 1997, and~     there is expected to increase by 300 million people in 2025. In addition, the expected~     survival time of patients with diabetes increase compared to previous. In the future, ESRD~     due to type 2 diabetes is expected to have a significant impact on the health industry.~     Therefore, prevention of progression to CKD and ESRD in diabetic patients is important to~     aspect of national health and economic problems. How to stop the progression of diabetic~     nephropathy is part of modern medicine to be solved.~      Strict glycemic control, blood pressure regulation, and use of renin-angiotensin system (RAS)~     blockers inhibit the development and progression of diabetic nephropathy. Microalbuminuria in~     diabetic patients has been recognized as a predictor of progression of diabetic nephropathy.~     Thus, the prevention of elevated urinary albumin excretion is an important therapeutic target~     for the prevention of renal and cardiovascular events.~      In patients with diabetes and hypertension, the drugs that block the RAS are used to treat~     proteinuria, but still a large number of patients with proteinuria are uncontrolled. In~     addition, ACE inhibitors or ARB agents actually have a limited effect on reducing the risk of~     cardiovascular or renal outcome. Also, sulodexide or pentoxyphylline which is reducing~     proteinuria have some weak evidence in terms of efficacy and safety. Therefore, the~     introduction of new alternative drugs are required.~      Already several study reported that calcitriol or paricalcitol in the renal injury model have~     renopreventive effect. In addition, in diabetic renal injury mice model reported that vitamin~     D receptor deficiency leads to glomerulosclerosis. Inhibition of the RAS with combination of~     paricalcitol and RAS inhibitors effectively prevent renal injury in diabetic nephropathy.~     Recently, Dick de Zeeuw et al reported that addition of paricalcitol to RAS inhibition safely~     lower residual albuminuria in patients with diabetic nephropathy. Recent studies reported~     that elevated concentrations of serum markers of the TNFα and Fas-pathways are strongly~     associated with decreased renal function in diabetic patients. However, the role of these~     markers in early progressive renal function decline are not clear. Therefore, the objective~     of this study is to identify the renoprotective effect as an new treatment of activated~     vitamin D (Calcitriol) indicating the TNF-α-related anti-inflammatory action and to seek the~     role as an important biomarker that the changes of TNFR in diabetic nephropathy can predict~     response to treatment.~   "
144712|NCT01673191|"~     There is a need to find an effective therapy for diabetic patients who develop macular edema~     after cataract surgery.~   "
144713|NCT01673178|"~     This is a trial in obese subjects who have poor lipid control with and without Type 2~     diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of~     PF-05231023~   "
144714|NCT01673165|"~     The purpose of this study is to determine if the use of fortified skimmed mother's milk is a~     safe alternative to specialized formula in the treatment of chylothorax following~     cardiothoracic surgery.~   "
144715|NCT01673152|"~     This study is designed to assess the effect of oligofructose administration for 12 weeks on~     Body Mass Index (BMI) of overweight and obese children.~   "
144716|NCT01673139|"~     This is a substudy of Generation 100. The investigators will follow the persons with atrial~     fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial~     fibrillation, symptoms, use of health services or echocardiographic findings.~   "
144717|NCT01673126|"~     Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to~     the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and~     attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised~     (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a~     double-blind sham-controlled experimental design.~   "
144718|NCT01673113|"~     Cryolipolysis with Zeltiq CoolSculpting device is a novel method of non-invasive fat removal.~     The technique works by application of cold plates to the skin surface for a single cooling~     cycle lasting 60 minutes, after which a cold-induced inflammatory panniculitis leads to~     selective loss of fat. There is no histologic evidence of necrotic or inflammatory damage to~     skin or nerves, however a single small human study has reported prolonged temporary altered~     sensation (hypoesthesia) in the area of cryolipolysis procedure. This hypoesthesia seen in~     about 2/3 of patients, is completely reversible, lasts up to 8 weeks after treatment, and~     suggests that cooling under these conditions can temporarily alter sensory nerve function.~      The purpose of this study is to further characterize the reversible cutaneous sensory~     function alteration after cryolipolysis with Zeltiq CoolSculpting device. Using multiple~     modalities of sensory nerve function we hope to elucidate the details of cryolipolysis~     induced sensory nerve alteration.~   "
144719|NCT01673100|"~     The purpose of this study is to test the feasibility of using targeted daily cell phone~     interaction to facilitate behavior change for physical activity in previously-sedentary~     individuals who have recently undergone a percutaneous coronary intervention (PCI).~   "
144720|NCT01673087|"~     Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient~     way to evaluate the biological impact of day-to-day stressors that people encounter as they~     go about their lives, since saliva is so easy to collect. However, the biological meaning of~     saliva cortisol measures has never been carefully examined. The goal of this study is to~     collect saliva from a large group of people as they go about their every-day lives, to~     measure their cortisol levels, and then study them in the laboratory where Investigators can~     learn more about how their stress response system (which produces cortisol) is really~     functioning. Investigators can then determine much more precisely what saliva cortisol levels~     really mean in terms of stress system biology. This will allow investigators to obtain much~     more useful information from the next decade of research on naturalistic stress and its~     biological impact using saliva cortisol measures, helping investigators to understand how~     stress undermines health and how to combat this effect.~   "
144721|NCT01673074|"~     The primary objective of the study is to determine the maximally tolerated photodynamic~     therapy (PDT) dose and drug-light interval of PDT using light and HPPH in patients with~     pleural malignancy who have undergone a maximal resection.~   "
144722|NCT01673061|"~     Cutaneous abscesses (boils) are collections of pus or infection in the skin, and are a~     frequent reason for emergency department visits. The only proven cure for abscesses is~     cutting them open and allowing the infection to drain, but this procedure is often painful.~     Currently, the usual method of pain control is to inject a numbing medication (lidocaine)~     into the site, but this injection itself is often painful and sometimes does not offer full~     pain relief. Although there has been some research into the use of non-injected numbing~     agents as another option, no studies have looked at the use of numbing sprays (vapocoolant)~     in this context specifically. The hypothesis of this study is that numbing spray is as good~     as injected numbing medication at relieving pain in patients having small abscesses opened~     and drained. This theory will be tested by taking two groups of patients having small~     abscesses drained in the Emergency Department, and assigning one group to get a numbing~     injection, and the other to get a numbing spray. Their levels of pain and satisfaction will~     be recorded before, during, and after the procedure, and the two groups will be compared.~   "
144723|NCT01673048|"~     Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced~     diaphyseal femoral fractures in children. However, some literature report high complication~     rates (10-50%) in complex fractures. Data of our own patients with special emphasis on~     complications showed also mediocre results. Thus, a biomechanical study was conducted to~     search for modifications. In this study the stiffness with a 3rd nail implanted was compared~     to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde~     ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral~     fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd~     from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm).~     Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression~     (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal~     rotation and 9° compression directions implantation of 3 nails became standard treatment for~     all dislocated femoral fractures at our department.~      All patients were followed prospectively. The following data was collected: Type of~     osteosynthesis, any kind of complication (additional procedures like cast or external~     fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time~     until full weight bearing and time until implant removal. At follow-up the legs were~     controlled for a possible length discrepancy and a possible deviation of axis. Patients`~     satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further~     on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1~     and 3-4 months (dependend on age).~      Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing,~     fracture, femur, treatment, children, adolescents.~   "
144724|NCT01673035|"~     Background~      Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with~     functional disability. Cognitive behavior therapy (CBT) and behavioral stress management~     (BSM) have been showed to be effective in the treatment of severe health anxiety. The~     mechanisms of the treatments are however poorly understood. In addition, effective~     psychological treatments are accessible to only a few. One prior RCT has shown that~     internet-based CBT could be effective in comparison to waiting list controls. More studies on~     internet-based CBT is essential to establish evidence. In addition, few studies with~     sufficient power have investigated the effect of CBT in comparison to other active~     treatments.~      Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to~     behavioral stress management (n=110) for adult participants with severe health anxiety. BSM~     is considered a comparison treatment for two reasons: it has been shown to be effective and~     it lacks exposure and response prevention, which is suggested to be an important mechanism in~     CBT.~      Participants in both treatments are expected to be significantly improved on measures of~     health anxiety. Participants receiving CBT are expected to be significantly more improved~     compared to participants receiving BSM.~   "
144725|NCT01673022|"~     Description:~      This is a multi-institutional study investigating the sensitivity and negative predictive~     value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after~     cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or~     cervical cancer at the time of their robotic surgical staging.~      Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by~     sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph~     nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel~     pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine~     pathologic processing according to standard of care for these surgical procedures. The~     pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity~     and negative predictive value in their ability to detect metastatic disease.~   "
144726|NCT01673009|"~     THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients~     with plexiform neurofibromas~   "
144727|NCT01672996|"~     To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To~     evaluate the safety and tolerability of low concentration Ioforminol Injections. Study~     recruits healthy volunteers.~   "
144728|NCT01672983|"~     This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of~     ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as~     ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b)~     or genotype 2 (HCV GT2) infection who were previous treated with pegylated~     interferon/ribavirin (pegIFN/RBV).~   "
144729|NCT01672970|"~     This multi-center observational study will evaluate the use of RoActemra/Actemra~     (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on~     RoActemra/Actemra treatment according to the local label will be followed for 6 months.~   "
144730|NCT01672957|"~     This observational study will evaluate renal function in participants who underwent renal~     allograft transplantation and are started on combined immunosuppressive treatment containing~     mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months~     following transplantation.~   "
144731|NCT01672944|"~     The purpose of this study is to evaluate English and Spanish language educational materials~     that inform the community about a type of cancer research that involves the collection,~     storage, and processing of biospecimens. Part A of this study involved creating surveys about~     biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin to~     evaluate education materials about biospecimen donation and research.~      Phase II consists of two independent randomized controlled trials. Each trial is being~     conducted independently to test English and Spanish language materials (75 subjects each).~   "
144732|NCT01672931|"~     We believe that there is an association between BMI and oocyte diameter in women undergoing~     IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF.~     One group will have BMI 20-25 and the other group will have BMI above 30.~   "
144733|NCT01672918|"~     Background:~      - Autoimmune lymphoproliferative syndrome (ALPS) is a genetic disorder of the lymph system.~     People with ALPS often have swollen lymph nodes, especially in the neck and armpit. They also~     have a much higher risk of developing lymphoma. It is not always easy to determine whether~     the swollen lymph nodes are caused by ALPS or by lymphoma. Researchers want to see whether~     different imaging studies can show the difference between ALPS and lymphoma. The studies used~     will be positron emission tomography (PET) and computed tomography (CT). Researchers will use~     a drug called fluorodeoxyglucose (FDG) to look at the lymph nodes.~      Objectives:~      - To see how well imaging studies can distinguish between swollen lymph nodes caused by ALPS~     or by lymphoma.~      Eligibility:~        -  Individuals must be 5 years of age or older and enrolled on the National Institutes of~          Health natural history study of ALPS.~        -  Participants should either have lymphoma or have symptoms that suggest possible~          lymphoma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have an FDG-PET/CT scan. It will be performed according to standard~          procedures.~        -  If the results of the scan do not show lymphoma, participants will stay on the study for~          1 year for clinical follow up. They may have a second FDG-PET/CT scan if there is a~          change in symptoms. Such changes include further enlargement of lymph nodes, unexplained~          fevers, or weight loss.~        -  If the results of the scan show evidence of new or worsening lymphoma, treatment on this~          study will end. Further tests based on clinical symptoms, including a lymph node biopsy,~          may be done under the ALPS natural history study to rule out or make a diagnosis of~          lymphoma.~   "
144735|NCT01672892|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This randomized phase III trial is studying two different methods of radiation and~     their side effects and comparing how well they work in treating endometrial and cervical~     cancer after surgery.~   "
144736|NCT01672879|"~     The primary objective of this study is to evaluate the safety and efficacy of simtuzumab~     (GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).~     It will consist of 2 phases:~        -  Randomized Double-Blind Phase~        -  Open Label Phase (optional)~   "
144737|NCT01672866|"~     The primary objective of this study is to evaluate whether simtuzumab (formerly referred to~     as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the~     clinical progression to cirrhosis in participants with non-alcoholic steatohepatitis (NASH).~      It will consist of 2 phases:~        -  Randomized Double-Blind Phase~        -  Open Label Phase (optional)~   "
144738|NCT01672853|"~     The purpose of this study is to evaluate whether Simtuzumab (GS-6624) is effective at~     preventing the progression of liver fibrosis in subjects with PSC.~   "
144739|NCT01672840|"~     The proposed study Dose And Response to Cocoa (DARC), will examine variation in dose of~     cocoa-containing product consumption over an 8-week period and assess effects on blood~     pressure, endothelial function and arterial stiffness. The randomized, controlled, modified~     Latin square parallel design will compare the effects of two doses of cocoa consumption on~     blood pressure, endothelial function and arterial stiffness in 120 adults with stage 1~     hypertension.~   "
144740|NCT01672827|"~     To Evaluate the Effectiveness of an Electronic Training Program for Orienting and~     Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.~   "
144741|NCT01672814|"~     This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure,~     also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen~     crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in~     patients with keratoconus.~   "
144742|NCT01672801|"~     The main purpose of this study is to test the effectiveness of nimodipine in preventing a~     luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene~     citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation~     to allow adequate recruitment of follicles, proper maturation of a dominant follicle before~     ovulation, and effectively time insemination with semen to allow fertilization of a mature~     egg to occur.~      The investigators are also conducting this study to determine medication side effect profile~     (including lightheadedness or dizziness from low blood pressure or rapid heart rate,~     headache, and nausea), patient treatment compliance, and clinical pregnancy (positive~     pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle~     stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on~     these hormones.~      As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of~     gonadotropin releasing hormone in animal and preliminary human studies. The investigators~     hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge~     during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients~     undergoing assisted reproduction with intrauterine insemination (IUI).~   "
144743|NCT01672788|"~     The primary objective of this trial is to establish bioequivalence of two FDC tablets and the~     single tablets when administered together after a high fat high caloric meal.~   "
144744|NCT01672775|"~     The purpose of this study is to evaluate the safety and pharmacokinetics and assess the~     immunogenicity and effectiveness of AGS-16C3F in subjects with renal cell cancer (RCC).~   "
144745|NCT01672762|"~     This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to~     diabetic patients.~   "
144746|NCT01672749|"~     The foremost challenge when managing early onset scoliosis (curve deformity before the age of~     10) is to prevent curve progression while maintaining growth of the spine. Current treatment~     options require repetitive interventions as the spine and the child grow. This study will~     compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué~     Trolley screws~      Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer~     re-operations after 3 years of follow-up (FU) than patients included in the comparison group~   "
144747|NCT01672736|"~     This is a multi-center, open-label, non-randomized study. Patients will receive ASP7487~     (OSI-906) in combination with bortezomib and dexamethasone. Phase 1 involves dose escalation~     of the combination, whereas Phase 2 involves the expansion of ASP7487 (OSI-906) combined with~     bortezomib and dexamethasone at the MTD to establish the ORR. This trial will accrue patients~     with relapsed or relapsed/refractory MM - a disease state for which bortezomib is approved to~     treat by the FDA and Health Canada. The combination of ASP7487 (OSI-906) with bortezomib is~     supported by pre-clinical work in MM in which the combination with an IGF1-R inhibitor~     enhances anti-tumor activity of bortezomib.~   "
144748|NCT01672723|"~     From birth we rely on others for comfort and care and derive pleasure from being together.~     Research from the fields of health psychology, social psychology, and public health converge~     to highlight the importance of having and maintaining good relationships for overall health.~     Indeed, having close friends and family and feeling connected to them has been called a basic~     need, similar to our need for food and water. It may not be a coincidence then that feelings~     of connection rely on similar systems in the body as other needs that are both basic and~     highly pleasing and rewarding. For instance, its possible that opioids, a substance in the~     body associated with pleasant, euphoric feelings, may also be important for connecting with~     others. This study will examine the role of opioids in feeling connected to others by~     administering a drug called naltrexone, that effects opioid processing in the body, on~     perceptions and feelings toward a number of tasks in the lab. Additionally, to assess the~     effects of naltrexone outside of the lab, participants will complete daily diary responses~     via text and online surveys.~      40 participants will take both placebo and naltrexone. Participants will complete two~     sessions, one in each drug condition, in which they complete a number of tasks including~     reading messages on a computer screen, holding a number of objects, and viewing images while~     undergoing electric shocks. Participants will also complete a daily diary for 14 days while~     on naltrexone and placebo. Prior to these lab sessions participants will be screened at~     UCLA's Clinical & Translational Research Center (CTRC) to ensure that they are healthy and~     that it is safe for them to take the study drug.~      We hypothesize that people will report feeling less socially connected when on naltrexone~     compared to placebo and will show subsequent changes in social behavior outside of the lab.~   "
144808|NCT01671943|"~     The purpose of this study is to evaluate the clinical feasibility and safety of the~     ICESENSE3TM cryotherapy system for the ablation of small malignant invasive breast tumors.~   "
144749|NCT01672710|"~     Gulf War illness is found in about one fourth of veterans of the 1990-1991 Gulf War and is~     characterized by persistent memory and concentration problems, headaches, fatigue and muscle~     and joint pain. It is not known what causes the illness, but exposure to chemicals is~     suspected. The Hubbard detoxification program consists of exercise and sauna therapy together~     with administration of several dietary supplements, particularly crystalline niacin used at~     increasing concentrations over a period of about four weeks. The investigators hypothesize~     that this program will reduce symptoms, as tested by administration of cognitive and quality~     of life tests and serum clinical chemistry tests.~   "
144750|NCT01672697|"~     Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in~     the post-partum period after a vaginal delivery complicated by genital trauma help to improve~     a woman's quality of life, specifically in regard to anal incontinence. To be able to study~     this, the investigators need to know how well the muscles of a woman's pelvic floor function~     after a vaginal delivery and this requires measuring their strength during a pelvic exam. At~     present, there are no studies that have looked at whether the intervention of PT/BT improves~     a woman's anal incontinence quality of life after sustaining genital trauma during vaginal~     deliveries~   "
144751|NCT01672684|"~     This randomized phase I trial studies at-home group video calling sessions in quality of life~     in rural patients with breast cancer. At-home group video calling support sessions may~     improve the well-being and quality of life of women who have breast cancer~   "
144752|NCT01672671|"~     The purpose of this study is to assess efficacy of platinum-based neoadjuvant chemotherapy in~     correlation with BRCA1-associated DNA repair dysfunction in patients with early triple~     negative breast cancer.~   "
144753|NCT01672658|"~     The goal of this clinical research study at RIC is to determine the value and benefit of the~     SK multimodal balance training system through independent clinical evaluations. The~     functional benefit of the SK Balance system will be measured by any improvements in balance~     and functional assessments.~      This study is primarily funded through Engineering Acoustics as a subcontract for a phase II~     Small Business Innovation Research by the Department of Defense.~      3) Hypotheses & Research Objectives and Purpose:~      The specific research questions to be addressed are:~        1. How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT~          intervention on balance and functional gait measures in mild traumatic brain injury~          (mTBI) participants.~        2. How do SKBS measurement tools compare to standard clinical assessments of gait and~          balance in mTBI patients The purpose of this clinical research study is to compare the~          value and benefit of the SK multimodal balance training system in combination with~          traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone~          through independent clinical evaluations. The functional benefit of the SK Balance~          system will be measured by any improvements in clinical measures of balance, functional~          mobility, and gait assessment.~   "
144754|NCT01672645|"~     The purpose of this study is to determine the safety and tolerability of multiple doses of~     PF-05402536 and PF-06413367 in healthy adult smokers.~   "
144755|NCT01672632|"~     It has been shown that large fat cells are associated with more risks for insulin resistance~     and more cardiovascular risk factors such as high cholesterol or triglycerides.~   "
144756|NCT01672619|"~     Being the craniostenoses sutural basically a disease, the fact that the brain being trapped~     in an enclosure that does not have complacency required to accompany their growth constitutes~     the challenge of treatment, which aims to restore the complacency of the suture and correct~     the stenotic compensatory cranial deformity.~      This paper proposes the combination of a helicoid osteotomy distraction osteogenesis provided~     by the use of springs distracting.~   "
144757|NCT01672606|"~     This study describe the effect of partial neuromuscular blockade of rocuronium on the acute~     hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.~   "
144758|NCT01672593|"~     Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of~     low-output ECFs. The primary objectives of this study are to compare the clinical efficacy,~     safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin~     sealant Bioseal® in the management of patients with low-output volume ECFs.~   "
144759|NCT01672580|"~     This project will examine the spread of health interventions with a randomized control trial~     design by introducing public health interventions in 32 villages in the Honduran Department~     of Lempira. Based on identified public health needs in the region, namely improved drinking~     water and diet, this study will provide training on the use of chlorine (sodium hypochlorite)~     for water purification and multivitamins for nutritional supplementation. In some villages,~     individuals selected for their social connectedness will be trained and given coupons that~     can be redeemed for either chlorine bleach or multivitamins, and these persons will be asked~     to spread this information and distribute coupons to four people of their choosing. In other~     villages, individuals selected at random will receive the same training, materials, and~     instructions. A second wave of coupon distribution will provide coupons to those who received~     a coupon from the original seed groups so that they may disperse these coupons further out~     in the social networks. Over the following months, study investigators will look at how~     knowledge of these health practices, and uptake or and adherence to the practices, spreads~     throughout the villages.~      More specifically, the investigators will examine the speed and extent of spreading of these~     new health practices after introducing them to three different initial seed groups: (1)~     people chosen on the basis of being named as a friend by many people in their village, (2)~     people chosen based on being named as a friend by a randomly chosen individual, and (3) a~     group of randomly chosen individuals. It is hypothesized that spread will occur faster and/or~     to a greater extent when the intervention is started in groups 1 and 2 versus group 3~     (control group).~   "
144760|NCT01672567|"~     The purpose of this study is to determine the effects of daily consumption of eggs or egg~     substitute for 6 weeks on endothelial function and on cholesterol and lipoprotein levels in~     participants with clinically established coronary heart disease (CHD).~   "
144790|NCT01672177|"~     The main aim of the project is to evaluate a self-care intervention program aimed at~     enhancing the ability of mildly disabled and healthy older persons in Singapore to manage~     their health.~      A secondary aim of the study is to evaluate the effectiveness of training community health~     workers located within Senior Activity Centres in Singapore to support the self-care capacity~     development amongst older persons in the locale.~   "
144761|NCT01672554|"~     This research will explore whether Quetiapine XR used primarily to treat psychosis may also~     cover for comorbid anxiety disorder and offer advantages in patients with schizophrenia and~     comorboid anxiety disorder. Preliminary data on pharmacological properties of Quetiapine and~     its metabolites and intuitive impression from our clinical experience lead to believe that~     Seroquel XR use in monotherapy may offer advantages over other antipsychotics in treating~     co-morbid anxiety disorder in patients suffering from schizophrenia. This open label switch~     study conducted in a schizophrenic population intends to verify this hypothesis.~   "
144762|NCT01672541|"~     The Dating Matters: Strategies to Promote Healthy Teen Relationships Initiative intends to~     promote respectful, nonviolent dating relationships among adolescents living in high-risk,~     urban communities. CDC has developed a comprehensive approach to promoting respectful,~     non-violent relationships based on current evidence based and evidence informed strategies.~     This comprehensive approach includes: school-based curricula for 6th, 7th, and 8th grade~     students; separate parent programs for parents of 6th, 7th, and 8th grade students; a~     communications campaign involving social media and near-peer brand ambassadors; an online~     training about dating violence for educators; policy assessment at the school or community~     level; and development and validation of school and community level indicators of teen dating~     violence. Additionally, schools assigned to the comprehensive condition will also receive~     intensive training and technical assistance to support implementation of these components.~     Among 4 U.S. sites, 44 schools will be randomly assigned to implement either the Dating~     Matters comprehensive approach or the standard of care approach, which we are~     operationalizing as Safe Dates, a an evidence based student curriculum for 8th graders. We~     hypothesize that the comprehensive approach will be more effective than the standard approach~     at preventing the perpetration and victimization of teen dating violence over time and at~     promoting positive relationship behaviors over time.~   "
144763|NCT01672528|"~     A multicentre, prospective observational study to develop, evaluate and validate Patient~     Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic~     cardiac arrhythmias~   "
144764|NCT01672515|"~     Stroke is one of the three leading causes of human death, and a major cause of adult~     disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent~     cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce~     infarct size of cerebral infarction. Investigators hypothesized that postconditioning would~     reduce infarct volume of ischemic stroke patients.~   "
144765|NCT01672502|"~     Firefighters frequently work extended duration shifts and long work weeks which have adverse~     effects on alertness, health, safety and performance. This protocol uses a survey instrument~     to examine the effects of extended duration shifts on safety outcomes (e.g., motor vehicle~     crashes, accidents, injuries), health (e.g., diagnosis and treatment of sleep disorders,~     improved general health indices, decreased number of sick days), and performance (e.g.,~     decreased response time). This study will expand understanding of the nature, scope, etiology~     and consequences of firefighter fatigue and increase our ability to develop guidelines that~     can be generalized across fire departments throughout North America. This study could provide~     an avenue to make lasting policy improvements that could enhance the safety, health, and~     performance of firefighters.~   "
144766|NCT01672489|"~     The purpose of this protocol is to assess the risk of drowsy driving amongst shift workers~     using objective measures of drowsiness and driving performance in an instrumented research~     vehicle.~   "
144767|NCT01672476|"~     A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive~     Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild~     to Moderate Essential Hypertension~   "
144768|NCT01672463|"~     This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot~     cohort of human recurrent malignant glioma patients. All patients will have been previously~     treated with the standard-of-care treatment which includes surgical resection, radiation and~     chemotherapy, and in some cases treatment for recurrent disease with investigational agents~     or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established~     by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic~     acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on~     this protocol.~   "
144769|NCT01672450|"~     This is a single center, open phase I dose escalation study. This study will assess the~     highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2~     (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous,~     subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the~     drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the~     combination.~   "
144770|NCT01672437|"~     The Danish regions aim to implement antenatal education in small groups for all expectant~     parents. The effects of general antenatal education for childbirth or parenthood, or both,~     remain largely unknown. Also it is unknown if antenatal education in small groups is superior~     to antenatal lectures which is currently standard care.~      The aim of the trial is to evaluate if antenatal birth and parent preparation in small groups~     can increase parenting resources thereby easing birth and creating a smoother and less~     stressful transition to parenthood among the participants, compared to those allocated to~     standard care. This in turn is hypothesized to improve health and thriving among newborn~     families and affect their use of healthcare services. A thorough process evaluation will be~     conducted highlighting enabling factors and barriers to the implementation. Finally~     cost-effectiveness analysis will be conducted.~      Individually randomised trial sited at Hvidovre Hospital, a large birth clinic in the~     Copenhagen Capital Region of Denmark.~      Participants: 1756 pregnant women ≥ 18 years old, recruited before 20+0 weeks gestation, due~     to give birth at Hvidovre Hospital. Being legally able and willing to provide signed consent,~     and being fluent in Danish.~      Women are randomised to receive:~        1. A research-based birth and parenting program. The intervention consists of 4 sessions in~          small groups that last for 2,5 hours per session at 25, 33 and 35 weeks of gestation,~          and a post-natal session 5 weeks after expected due date.~        2. Standard care (control group). The pregnant woman and her partner are offered two~          antenatal lectures in an auditorium.~      The allocation of participants to the intervention will be 1:1 to the intervention and the~     control group.~      Data will be collected via questionnaires at baseline, 37 weeks gestation, 9 weeks~     post-partum, 6 months post-partum and 1 year post-partum, via the hospital obstetric~     database, and via the national registers. Analyses will be intention to treat. Subgroup~     analysis will be conducted in relation to personal and demographic characteristics. Process~     evaluation will be conducted using questionnaires and qualitative interviews. The incremental~     societal cost of the intervention will be computed and compared to the measured outcomes in a~     cost-effectiveness analysis.~      Outcomes: Stress, parenting alliance, depressive symptoms, wellbeing obstetric intervention,~     use of health care services, self-efficacy, divorce.~   "
144803|NCT01672008|"~     This study is designed to evaluate the safety, tolerability and efficacy profile of NOX-100~     to reduce intradialytic hypotension (IDH) in patients undergoing chronic hemodialysis (HD).~   "
144771|NCT01672424|"~     Hypothesis: The volume of gastric contents will be the same for a high protein drink versus~     ice chips as measured by ultrasound at 20 minute intervals for two hours in the laboring~     parturient.~      Specific Aim: To determine the volume of gastric contents at various time intervals (every 20~     minutes for 2 hours) in patients with an epidural that are given a high protein drink versus~     those that are given ice chips, with ultrasound.~   "
144772|NCT01672411|"~     In Europe, prostate cancer (PCa) is the most common solid neoplasm, with an incidence rate of~     214 cases per 1000 men, outnumbering lung and colorectal cancer. Early detection tests have~     been developed in order to identify PCa while it is still confined to the prostate gland.~      The two most commonly used tests are digital rectal examination and serum prostate-specific~     antigen (PSA) level: however, most of cases is detected in the so called T1c stage, i.e. for~     PSA increasing only. As marker, PSA is organ-specific but not cancer-specific, and its levels~     may change as result of physical activity, sexual activity, in the presence of benign~     prostatic hyperplasia (BPH), acute and chronic prostatitis, as well as in the presence of~     PCa.~      A total serum PSA of 4.0 ng/ml has traditionally been used as threshold for considering~     prostate biopsy and large programs for the early detection of prostate cancer have shown that~     almost 70% of cancer cases can be detected using a PSA cutoff of 4.0 ng/ml. However, using a~     PSA threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected~     (false-negative) and the false-positive rate is 65%. To improve the usefulness of PSA for~     identifying patients who require biopsy, the PSA threshold has been lowered at 2 ng/ml;~     moreover, the levels of free and bound PSA have been assessed, together with PSA density (the~     rate of PSA over the prostate volume) and PSA velocity (the rate of PSA increase), which seem~     to have some validity for detecting prostate cancer.~      Recent studies have shown that other new biomarkers could be used in the diagnosis of early~     prostate cancer as they showed a higher sensitivity and specificity. In the last two years,~     several investigators showed that PSA isoform [−2] proPSA (p2PSA) and its derivatives,~     namely, percentage of p2PSA to free PSA (%p2PSA) and the Prostate Health Index [PHI; (p2PSA /~     free PSA) × √tPSA)] improve the accuracy of total PSA (tPSA) and percentage of free PSA~     (%fPSA) in predicting the presence of PCa at prostate biopsy and they are also related to PCa~     aggressiveness at biopsy.~      The aim of this study is to confirm the diagnostic and prognostic predictive value of~     prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index~     in the detection of prostate cancer in patients with a PSA 2-10 ng/ml and/or suspicious DRE.~   "
144773|NCT01672398|"~     Background: Patients hospitalized with complex chronic conditions frequently experience~     preventable short-term readmissions due to inadequate transition support. Although structured~     discharge planning with telephone follow-up improves transition outcomes, these services~     often are unavailable, and proactive outreach is often inadequate once the patient returns~     home. Informal caregivers are invaluable for ensuring successful transitions, but many~     patients live alone, have an in-home caregiver who is struggling with competing demands, or~     live at a distance from adult children or other potential sources of support. New models are~     needed for transition support that include low-cost technologies and more structured~     assistance for patients' informal caregiving network, while providing patients' clinical~     teams with the information they need to avert health crises.~      Objectives: Consistent with Agency for Healthcare Research and Quality goals to improve~     transitions using accessible health IT, we will evaluate a novel intervention designed to~     improve the effectiveness of transition support for common chronic conditions via three~     mechanisms of action: (a) direct tailored communication to patients via automated calls post~     discharge, (b) support for informal caregivers via structured feedback about the patient's~     status and advice about how they can help, and (c) support for proactive care management~     including a web-based disease management tool, automated alerts about potential problems, and~     the capacity for asynchronous communication with patients and their caregivers. Specifically,~     the trial will determine: 1) whether the CarePartner intervention improves patients'~     readmission risk and functional status; 2) the impact of the intervention on patients'~     self-care behaviors and the quality of the transition process; and 3) whether the~     intervention improves caregiver burden and stress levels.~   "
144774|NCT01672385|"~     Background: Older hospitalized adults frequently experience preventable short-term~     readmissions due to inadequate transition support. Although proactive telephone follow-up~     improves transition outcomes, these services often are unsystematic and of low intensity.~     Informal caregivers are invaluable for ensuring successful transitions, but many patients~     live alone, have an in-home caregiver who is struggling with competing demands, or live at a~     distance from adult children or other potential sources of support. New models are needed for~     transition support that include low-cost technologies and more structured assistance for~     patients' informal caregiving network, while providing patients' clinical teams with the~     information they need to avert health crises.~      Objectives: Consistent with NIA's goals to improve transition outcomes, we will evaluate a~     novel intervention designed to improve the effectiveness of transition support for older~     adults with common chronic conditions via three mechanisms of action: (a) direct tailored~     communication to patients via regular automated calls post discharge, (b) support for~     informal caregivers living outside of the patient's household via structured feedback about~     the patient's status and advice about how they can help, and (c) support for proactive care~     management including a web-based disease management tool, automated alerts about potential~     problems, and the capacity for asynchronous communication with patients and their caregivers.~     Specifically, the trial will determine: 1) whether the CarePartner intervention improves~     patients' readmission risk and functional status; 2) the impact of the intervention on~     patients' self-care behaviors and the quality of the transition process; and 3) whether the~     intervention improves caregiver burden and stress levels.~   "
144775|NCT01672372|"~     The proposed study is a 60-day, randomized, double-blind, placebo-controlled trial to~     evaluate the efficacy of a methylated vitamin B complex nutritional supplement (Max Stress~     B™) for improving depressive and anxiety symptoms according to the Beck Depression and~     Anxiety Inventories, respectively, in 60 patients (18+ years of age) diagnosed with major~     depression or other forms of depressive disorders and an elevated level of homocysteine (> 10~     µmol/L) at baseline. Secondary outcomes will include anthropometrics for body composition,~     blood pressure and pulse, level of physical activity, dietary intake, and quality of life.~     Participants will be assessed at baseline and 30 and 60 days. The study will consist of two~     treatment arms: (a) vitamin B complex nutritional supplement and (b) placebo.~      The information obtained in this study will help in determining the efficacy of using~     nutritional supplements for improving the outcomes of people with depression.~   "
144776|NCT01672359|"~     A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC~     Synergy® and Catalyn® on cognitive and immune function markers and quality of life among~     healthy older adults with no history of significant cognitive deficits~   "
144777|NCT01672346|"~     In this prospective randomized study, we aim to compare the rate of PV reconnection following~     PVAI performed at different energy settings (30 Watts vs 40 Watts) where dormant PV~     conduction will be unmasked by adenosine-provocation.~   "
144778|NCT01672333|"~     Early stage diagnosis of gastric cancer has ensued different approaches in its resection~     strategies. In order to increase the proportion of cases that undergo radical resection and~     reduce the recurrence rate, different pre-operative treatments are introduced. Here, the~     investigators investigate an active preoperative chemotherapeutic regimen to in patients with~     locally advanced gastric cancer.~   "
144804|NCT01671995|"~     This study examines whether a nurse monitored management program at the hospital heart~     failure outpatient clinic can improve quality of life in elderly patients with chronic heart~     failure, as compared to standard treatment in primary healthcare.~   "
144779|NCT01672320|"~     The objectives of this study are to evaluate the clinical value of robotic-assisted total hip~     arthroplasty with respect to acetabular cup implantation, and to document the long-term~     clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained~     at every study site to evaluate the basic clinical outcomes and post-operative component~     placement accuracy of each MAKO® THA patient.~      The hypothesis is that robotic preparation of the acetabulum will significantly reduce the~     variability and inaccuracy in the component alignment parameters that lead to post-operative~     complications, including implant failure.~   "
144780|NCT01672307|"~     The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of~     eyebrows.~   "
144781|NCT01672294|"~     Informal caregivers provide a majority of care for patients during serious illness. Lack of~     preparation and completion may leave caregivers less capable of caring for a loved one or~     making crucial decisions influencing care.~      This study will examine whether a preparation and completion intervention reduces caregiver~     anxiety, depression, anticipatory grief, and burden and improves patient quality of life and~     health care use.~   "
144782|NCT01672281|"~     In endurance sports competitions such as cycling, an athlete's capacity to sustain submaximum~     power (i.e. endurance capacity) strongly influences overall race performance. Endurance~     capacity can be increased by both long, continuous endurance exercise at moderate oxygen~     consumption, and high-intensity (at or above peak oxygen consumption) interval training.~     However, it has also been shown that resistance exercise, if performed in addition to~     endurance exercise, can further enhance endurance capacity. The investigators have recently~     described a novel training method, which is based on combined vibration and resistance~     training and superimposed vascular occlusion. Based on the investigators previous results~     showing that this type of training leads to marked increases in endurance capacity in~     previously untrained young women, the investigators aim at investigating whether the method~     is also effective in increasing endurance capacity in highly endurance-trained young men, and~     whether the method leads to bigger improvements relative to resistance exercise alone.~     Besides the functional outcomes the investigators are also interested in the specificity of~     the cellular adaptations with respect to the two trainings methods.~   "
144783|NCT01672268|"~     This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People~     with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter~     aortic valve implantation (TAVI).~   "
144784|NCT01672255|"~     Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote~     weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and~     HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced by~     diabetic individuals because of the fear of low blood sugar (hypoglycemia). My laboratory has~     demonstrated that Autonomic nervous system (ANS) counterregulatory failure plays an important~     role in exercise associated hypoglycemia in Type 1 DM. ANS responses are significantly~     reduced in Type 1 DM and are further blunted by antecedent episodes of hypoglycemia.~     Furthermore, there is a large sexual dimorphism of reduced ANS responses during submaximal~     exercise in both Type 1 DM and healthy individuals that is unexplained. Accumulating data are~     demonstrating that serotonergic pathways can regulate ANS discharge. Generally, serotonergic~     pathways are inhibitory but both single and longer term administration of selective serotonin~     reuptake inhibitors (SSRI's) such as Prozac has been demonstrated to increase basal~     epinephrine levels and enhance baroreflex control of Sympathetic nervous system (SNS)~     activity. What is unknown is whether fluoxetine can also enhance SNS responses and also~     override the large ANS sexual dimorphism present during sub maximal exercise. Therefore, the~     purpose of this study is to determine if the SSRI fluoxetine (Prozac) can improve SNS~     responses during exercise.~   "
144785|NCT01672242|"~     Respiratory distress is a common problem in an intensive care unit. There are multiple~     mechanisms that are used to help patients who are in respiratory distress including~     mechanical ventilation, continuous positive airway pressure (CPAP), bilevel positive airway~     pressure (BiPAP), high flow oxygen, and oxygen supplementation through nasal cannula or a~     facemask.~      The purpose of this study is to evaluate the mechanism by which Vapotherm, a high flow oxygen~     system, provides breathing support. Vapotherm provides high flow oxygen at different flow~     rates, meaning one can increase the amount of oxygen flow to help with breathing support. The~     investigators believe that this high flow oxygen system may provide similar breathing support~     that a continuous positive airway pressure machine (CPAP) machine does.~   "
144786|NCT01672229|"~     This study will investigate whether bortezomib can control the immune system and can be used~     to treat GVHD. Bortezomib has been used with not too many serious side effects in patients~     with multiple myeloma who will undergo transplant and also for acute graft versus host~     disease.~   "
144787|NCT01672216|"~     Previous studies revealed only a low evidence for the various biofeedback methods and pelvic~     floor exercises for treatment of chronic obstipation. The number of randomized controlled~     trials is low with in part significant systemic deficiencies. However, the results from the~     previous study with 3T treatment in patients with obstructed defecation syndrome (ODS) are so~     promising that a further randomized controlled trial appears useful to demonstrate a higher~     degree of evidence. The purpose of this study is to determine whether triple target treatment~     (3T) or EMG-Biofeedback alone are effective in the treatment of chronic obstipation and if~     the duration of treatment (3, 6 or 9 months) influence the efficacy.~   "
144788|NCT01672203|"~     Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased~     morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for~     development of CTEPH. It is not known, whether the location of pulmonary embolism (central~     vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been~     performed to assess the CTEPH incidence in different populations: in patients with central~     vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.~   "
144789|NCT01672190|"~     The purpose of this study is to assess the feasibility of recruiting women with urinary~     incontinence into a randomized controlled trial of a yoga therapy program.~   "
144805|NCT01671982|"~     To assess the drug concentrations of tenofovir (TDF) in HIV-infected Thai adults with~     moderate renal function impairment when administered at the recommended dose of 300 mg every~     48 hours, and at an alternative dose of 150 mg every 24 hours.~   "
144791|NCT01672164|"~     The main focus of this study is to develop blood and/or urine tests that will help to detect~     early signs of rejection in people who have had a liver transplant. Researchers will examine~     blood, urine, and tissue samples and try to identify markers for certain conditions such as~     rejection, response to therapy, and scarring of the liver. Additionally, researchers would~     like to identify biomarkers that can detect damage to the native kidneys before blood levels~     of creatinine rises. By studying gene expression, researchers hope to be able to diagnose~     these conditions earlier and improve liver survival.~   "
144792|NCT01672151|"~     The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune~     Thrombocytopenic Purpura (RITP) and explore the further mechanism.~   "
144793|NCT01672138|"~     This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal~     atrial fibrillation patients using different ablation strategies such as 1) PVAI alone, 2)~     PVAI+ CFAE, 3) PVAI+ CFAE+ non-PV trigger ablation.~      [ PVAI: Pulmonary Vein Antrum Isolation CFAE: Complex Fractionated Atrial Electrograms Non-PV~     triggers: Triggers arising from sites other than pulmonary veins]~   "
144794|NCT01672125|"~     Lymphedema is one side effect of breast cancer treatment. Measuring the edematous limb~     enables monitoring changes in the lymphedema and the effect of treatment. Circumference~     measurement using a measuring tape is an inexpensive simple method and therefore useful and~     widespread in clinical practice. Circumference measurement performance varies amongst~     therapists and lacks uniformity in the literature. To date, the effect of different limb~     positions on measurement results has not been examined.~      Purpose: The purpose of this study is to describe 1) the effect of position on upper limb~     volume measurement by using circumference measurement and 2) to examine whether the~     difference between positions are similar in the upper limbs of the same woman, and 3) between~     groups of women who are in the intensive phase, in the maintenance phase of lymphedema~     treatment and women without lymphedema~   "
144795|NCT01672112|"~     The efficacy of codeine is dependent on its demethylation to morphine. This extent of~     demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic~     variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors.~      Codeine has been the mainstay of analgesia for patients after craniotomy for many years.~     Traditionally, craniotomies were not thought to be very painful procedures, hence the use of~     codeine, a moderately potent opioid (when compared to morphine).~      However, in recent years, it has been found that up to 70% of post-craniotomy patients have~     moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies~     have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and~     patients on these stronger opioids generally had lower pain scores and better satisfaction.~      No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral~     codeine.~      Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain~     relief in post-craniotomy patients.~   "
144796|NCT01672099|"~     In this study, the beneficial effect of a nutrient enriched dairy product will be~     investigated on vitamin K-status. To achive this benefit, the study product contains extra~     vitamin K2. In addition, extra dairy minerals have been added to the study product that may~     support general health.~   "
144797|NCT01672086|"~     The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a~     retrospective, multi-center, single-arm study intended to collect data on the survivorship~     and long-term safety and effectiveness of the device.~   "
144798|NCT01672073|"~     The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the~     arterial line doesn't significantly attenuate the arterial pressure wave form. The principal~     aim of the trial will be:~      • To obtain quantitative data allowing investigation of the pressure wave form obtained in a~     standard arterial line compared to various arterial lines fitted with the Proxima 3.~   "
144799|NCT01672060|"~     Nurse-Family Partnership (NFP) is a primary prevention program that was developed by Dr.~     David Olds in the United States (US) with the goal of helping vulnerable young first-time~     mothers and their children. The program involves public health nurses (PHNs) visiting mothers~     in their homes, providing intensive supports starting in pregnancy and continuing until~     children reach their second birthday. Studies in the US have shown that NFP significantly~     reduces child maltreatment and child behaviour problems, while also improving children's~     early learning and mother's economic self-sufficiency. Economic studies have also shown that~     the program pays for itself over the long-term. However, NFP has never been tested in Canada.~     Due to major differences in our populations and in our public services, we do not know~     whether NFP will show the same benefits here. We therefore plan to conduct a scientific~     evaluation of NFP's effectiveness in British Columbia (BC), in close collaboration with the~     BC government and BC's Health Authorities. Using randomized-controlled trial methods, NFP's~     effectiveness will be specifically evaluated in comparison with existing perinatal services~     in BC regarding outcomes across three fundamental domains: 1) pregnancy and birth; 2) child~     health and development; and 3) maternal health and life course. Findings from this evaluation~     will be used to improve the NFP program — to better meet the needs of vulnerable young~     mothers and their children in BC.~   "
144800|NCT01672047|"~     The investigators hypothesize that the chronic kidney disease patients who suffer from~     vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery~     calcification and hyperparathyroidism will be improved.~   "
144801|NCT01672034|"~     The purpose with this study is to investigate whether gastric bypass surgery and the~     following weight reduction impact the tone in esophageal sphincters and the esophageal~     function.~      In a previous study our group used high resolution solid-state manometry to investigate the~     pressure in the esophagus and esophageal sphincters in obese patients going through~     laparoscopic bariatric surgery. These studies showed that the barrier pressure between the~     stomach and esophagus is significantly lower in obese compared to lean patients. In this~     study the investigators will examine these patients once more, now after weight reduction to~     see whether the barrier pressure is back to normal compared to lean patients.~   "
144802|NCT01672021|"~     Because MRI can provide increased brain and liver lesion detection as compared with CT, the~     investigators hypothesize that FDG-PET/MRI will provide concordant or improved lesion~     detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation~     dose.~   "
144806|NCT01671969|"~     The purpose of this study is to determine whether a very low calorie diet will stabilize or~     improve diabetic kidney disease.~   "
144809|NCT01671930|"~     Introduction~      Cardiovascular disease is the leading cause of death in the Western world. The main cause for~     cardiovascular events is the development of atherosclerosis in the coronary arteries. In more~     than 70% of cases, myocardial infarctions are caused by atherosclerotic plaque rupture, which~     results in subsequent formation of an occluding thrombus. Plaques that have a high risk of~     rupture are called vulnerable plaques. Cardiovascular imaging provides a complementary~     diagnostic approach in the assessment of cardiovascular risk in patients. However, the lack~     of biological detection possibilities of current imaging technologies limits their predictive~     value. For instance, multi detector computed tomography (MDCT) is an excellent tool to~     visualize coronary atherosclerosis. However, individual risk assessment is still problematic.~     Which of the diagnosed atherosclerotic plaques will undergo plaque rupture and lead to acute~     vascular events is currently hard to predict. Potentially, serum biomarkers could help~     identify the patient at risk. A wide variety of prognostic markers related to atherosclerosis~     have been identified in the past to predict for cardiovascular events. Nevertheless, their~     predictive value in individual patients is still limited. A difficulty in serum biomarker~     research is the requirement of large patient cohorts to study the relation between event rate~     and serum biomarker levels. The necessity to perform lengthy and costly studies, hinders the~     translation of novel cardiovascular serum biomarkers into the clinic. An alternative approach~     could be to study the correlation between levels of serum biomarkers and the presence of~     atherosclerosis in the coronary arteries.~      Study objectives~      Primary objective of the present analysis is to investigate the predictive value of a variety~     of serum biomarkers to predict atherosclerosis in the coronary tree of patients undergoing~     cardiac MDCT.~      Design and Methods~      Patients undergoing cardiac MDCT are eligible for the study. Excluded are patients with acute~     coronary syndrome, hemodynamic instability, pregnancy, severe renal insufficiency, allergy~     for contrast medium and inability to obtain informed consent. Permission to store the serum~     samples for future analysis of new prognostic markers for cardiovascular events will be~     acquired from the patients. Written information is send to the patient at least 1 week prior~     to CT. The samples will be stored coded, at the Biobank Maastricht, for a maximum duration of~     15 years. Once measurements from the samples will be performed, the serum samples will be~     sent by the Biobank coded to the analyzing researchers, which have no access to the key file~     where codes are linked to the specific hospital identity number. This file will be stored by~     an independent researcher at the Cardiology department of the Maastricht University Medical~     Center. The assessment of atherosclerotic burden of the coronary tree will be performed by~     cardiac MDCT specialists blinded to the clinical data and serum biomarker outcome. Biomarker~     levels are correlated to the severity and amount of coronary artery disease as assessed by~     cardiac MDCT.~   "
144810|NCT01671917|"~     The purpose of this study is to determine whether a standardized education and exercise~     program proposed before a total knee replacement for knee osteoarthritis is effective in~     functional recovery after surgery.~   "
144811|NCT01671904|"~     This multi-center, open-label, dose-finding study will evaluate the safety and~     pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with~     bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to~     participants with relapsed/refractory or previously untreated CLL. The study will explore two~     schedules for drug administration, Schedule A (venetoclax introduced before other agents) and~     Schedule B (introduced after other agents). In addition, the study will explore two~     venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is optional).~     The study is comprised of two stages for each participant population: a dose-finding stage~     and a safety-expansion stage. The dose-finding stage will explore multiple doses of~     venetoclax to be used in combination with fixed doses of BR or BG.~   "
144812|NCT01671891|"~     Rectal cancer is one of the most common malignant tumors in the world. However, there's also~     no reliable and sensitive method to monitor diseases and evaluate therapy responses till now.~     Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a~     promising method in this field. This study is to investigate the role of circulating tumor~     cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.~   "
144813|NCT01671878|"~     In this study, postprandial glucose and insulin responses of different foods will be measured~     in individuals with varying body weight.~   "
144814|NCT01671865|"~     The purpose of this research study is to identify and study changes in muscle in people with~     facioscapulohumeral muscular dystrophy using magnetic resonance imaging and spectroscopy.~   "
144815|NCT01671852|"~     Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep~     characterized by prolonged partial upper airway obstruction and/or intermittent complete~     obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition~     occurs in 2-5% of children and can occur at any age, but it is most common in children~     between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease,~     growth delay, poor learning and behavioral problems such as inattention and hyperactivity.~     The most common underlying risk factor for the development of OSA is enlargement of tonsils~     and adenoids. Given the potential risk of complications associated with surgery of the~     tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been~     considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent~     Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to~     moderate OSA4. The authors recommended that further randomised controlled studies were~     required to evaluate the efficacy of INCSs in children with OSA. In particular they~     recommended that future studies should employ sleep studies to look for any improvement with~     INCSs, and should include children with more severe OSA, as these are the patients at the~     greatest risk of complications of surgery and would benefit most from a non-surgical~     treatment. The purpose of this study is therefore to explore the efficacy of INCSs in~     children with the full spectrum of OSA severity, including sleep study analysis., and longer~     term follow-up.~   "
144816|NCT01671839|"~     The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System~     for the improvement in the appearance of cellulite.~   "
144817|NCT01671826|"~     Autologous stem cell transplantation remains the gold standard of treatment for newly~     diagnosed patients under the age of 65. Even though it is also regularly performed above the~     age of 65, there are very few data in this patient population. The investigators will capture~     safety and efficacy data in that setting.~   "
144818|NCT01671813|"~     The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in~     patients with a certain type of large B-Cell Lymphoma. The side effects (unwanted effects) of~     SGN-35 in patients with this certain type of large B-Cell Lymphoma will also be studied. It~     is not known if brentuximab vedotin is better or worse than other treatment that might be~     given.~   "
144819|NCT01671800|"~     The objective of this study is to determine if Myobloc significantly decreases~     prosthesis-associated symptomatic sweating in amputees when compared to a saline solution~     placebo. The study is randomized, double-blind, placebo-controlled, crossover trial with a~     total enrollment of 32 amputee subjects.~   "
144820|NCT01671787|"~     This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil~     fumarate (TDF).~   "
144821|NCT01671774|"~     The purpose of the trial is to assess the immunological effects and their kinetics, the~     safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of~     Interleukin-2 in subjects with advanced gastroesophageal cancer.~   "
144822|NCT01671761|"~     Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in~     two age groups: adolescents and young adults.~   "
144823|NCT01671748|"~     Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard~     treatment in the UK for patients with VLUs is compression bandaging or stockings. The MIST~     ultrasound system is a noncontact device which delivers low frequency ultrasound through a~     gentle saline mist directed at a patient's wound. This study aims to determine whether the~     use of the MIST device used in combination with standard treatments can improve healing of~     VLUs compared to UK standard practice. This will be assessed by measuring any reduction in~     wound size in the two groups after receiving 8 weeks of either Standard Care once a week or~     MIST combined with Standard Care three times a week.~   "
144824|NCT01671735|"~     This study will collect baseline survey data from a NCP funded VA Diabetes Prevention Program~     (VA DPP) clinical demonstration program at three medical centers on VA DPP participants and~     VA DPP-eligible VA MOVE! participants to identify baseline participant demographic~     characteristics; attitudes and beliefs about diet, exercise and weight loss, and psychosocial~     constructs such as social support; and self-regulation skills that predict 6-month weight~     loss and program attendance. The data collected will contribute to our knowledge of~     pre-diabetic Veterans' attitudes and beliefs about diet, exercise and weight loss, to our~     understanding of how different programs may impact weight loss, and to evidence-based~     targeting in future clinical implementation projects. It will also provide baseline quality~     of life data for use in a future cost-effectiveness analysis.~   "
144825|NCT01671722|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
144826|NCT01671709|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
144827|NCT01671696|"~     The main hypothesis being tested is that imaging and serologic biomarkers of apoptosis and~     progressive extracellular matrix remodeling will precede echocardiographic indices of~     systolic and diastolic function among childhood cancer survivors treated with anthracyclines~     thus allowing evaluation of new therapies to prevent and manage heart failure in these~     patients.~   "
144828|NCT01671683|"~     The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant~     chemotherapy with capecitabine during the resting periods in patients with locally advanced~     rectal cancer.~   "
144829|NCT01671670|"~     Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia~      Design:~        -  A single blind randomized controlled trial~        -  200 participants will be included~        -  Two arms: acupuncture and sham acupuncture group~   "
144830|NCT01671657|"~     The purpose of this clinical investigation is to gather data to evaluate the impact of using~     Eeva with traditional morphology grading on implantation rates.~   "
144831|NCT01671644|"~     The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva~     with traditional morphology grading on clinical pregnancy rates.~   "
144832|NCT01671631|"~     The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration~     is currently required for functional evaluation of stenosis severity using the fractional~     flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the~     instantaneous wave-free ratio (iFR), was recently introduced.~      Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free~     pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow~     reserve (FFR) in ACS patients.~   "
144833|NCT01671618|"~     The purpose of this prospective study is to compare point-of-care focused cardiac ultrasound~     (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending~     aortic dimensions. We hypothesize that FOCUS will demonstrate good agreement with CTA in the~     measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal~     disease.~   "
144834|NCT01671605|"~     There is currently little understanding of macrophage cholesterol homeostasis and foam cell~     formation across the spectrum of CKD. We hypothesize that an inverse relationship exist~     between the severity of CKD and processes underlying foam cell formation, and that the~     relationship becomes independent of serum lipoprotein levels as renal function declines. We~     propose to systematically examine scavenger receptors and cholesterol uptake as well as~     cholesterol transporters and efflux mechanisms in individuals with normal renal function,~     patients with moderate CKD. We further propose to determine if processed contributing to foam~     cell formation are related to the plasma lipid profile and if the relationship is modified by~     co-morbidities, such as diabetes, obesity, systemic inflammation which are common in this~     population and directly influence vascular integrity. These data will be critically important~     to understand when the abnormality starts and will provide crucial information.~   "
144835|NCT01671592|"~     This study will evaluate the safety and feasibility MRI tracking of a vaccine produced from a~     persons cancer cells injected intradermally once a day for 3 consecutive days. One of the~     daily doses will contain a chemical that can be detected by an MRI. That will be either the~     1st or 3rd day of the 3 day course. On that day MRI scans will be performed 6 and 24 hours~     after the injection on that day. Patients may be able to receive booster doses every 1-2~     months~   "
144836|NCT01671579|"~     To establish the accuracy of bowel ultrasound in the follow-up of known (previously~     diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance~     imaging technology used to obtain detailed images of the small bowel) as the reference~     standard.~   "
144837|NCT01671566|"~     Adults with congenital heart disease have various degrees of impaired exercise capacity~     compared to healthy controls. Impaired exercise capacity makes everyday activities more~     difficult and demanding. There are few studies on effect of exercise training in adults with~     congenital heart disease. The hypothesis of this study is that structured home based exercise~     training will improve exercise capacity and health status in the studied population.~   "
144856|NCT01671319|"~     The purpose of this study is to determine the feasibility of giving standard TC chemotherapy~     on a dose dense schedule (ddTC) as well as evaluating the nature and frequency of ddTC side~     effects.~   "
144857|NCT01671306|"~     Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral~     development in non-diabetic patients with stable coronary artery disease. Our aim in this~     study is to find out any possible relationship between the levels of circulating monocyte~     subsets and coronary collateral development in type 2 diabetic patients.~   "
144838|NCT01671553|"~     Background The home is the primary source of SHS exposure. The scientific evidence shows that~     there is no risk-free level of exposure to SHS that stop smoking is the sole way to~     completely eliminate the risk of SHS exposure. Although research studies indicated that~     smoking bans in restaurants, bars, and workplaces can significantly reduce the level of SHS~     exposure, governments lack the authority to restrict smoking in homes. Therefore, parental~     cessation is a more effective means to reduce the SHS exposure.~      Aim The aims are (1) to promote smoking cessation in the community and (2) assess the effect~     of different smoking cessation approaches through the Smoke-free Teen Contest. The specific~     objectives of the study are to test the effectiveness of different smoking cessation~     approaches on quit rate and change in smoking behaviours among smokers who are referred by~     Hong Kong Council on Smoking and Health (COSH).~      Methods The referred smokers were nominated by primary 1 to secondary 3 students who joined~     the Smoke-free Teen Contest organized by COSH. Two domains of outcome will be assessed: (1)~     the primary outcome is the self-reported 7-day point prevalence (pp) quit rate at 6 months~     and (2)the secondary outcomes included (i) biochemical validated quit rate at 6 months and~     (ii) rate of smoking reduction by at least of half and (iii) number of quit attempts at 6~     months.~      Procedure Smokers, who are referred by the Hong Kong Council on Smoking and Health (COSH),~     were nominated by primary 1 to secondary 3 students joined Smoke-free Teen Contest organized~     by COSH. Those smokers will be randomized into two groups (Intervention group and Control~     group) using the clustered randomization method by school. After the clustered randomization,~     the oral consent of eligible subjects were obtained to the study through telephone interview.~     Intervention group will receive 1,2,3, 8-week and 6-month telephone follow-up after baseline,~     while control group will only receive 6-month telephone follow-up after baseline. Those~     participants who reported to have stopped smoking will be invited for biochemical validation~     of smoking status at 6-month follow-up.~      Hypothesis We hypothesize that the intensive telephone counselling plus NRT treatment will~     lead to significant increases in rates of smoking cessation in the intervention groups than~     the control group.~   "
144839|NCT01671540|"~     In this study the invetigators seek an answer on the following hypothesis:~        -  What are the long term effects of an IPV treatment evaluated with classical outcome~          parameters? (FEV1, Raw)~        -  Is the possible effect noticeable on the novel technique and is this comparable with the~          classical outcome parameters?~   "
144840|NCT01671527|"~     The purpose of this research study is to determine the physical brain changes in people with~     cervical dystonia after deep brain stimulation (DBS) surgery and as compared to healthy~     controls. We will do this by measuring your body's response to transcranial magnetic~     stimulation (TMS) before and/or after DBS surgery.~      TMS is a non-invasive procedure during which you sit in a chair that looks like one you would~     find at the dentist's office. A nerve stimulator is placed on the wrist of the right hand to~     stimulate the median nerve; the intensity of the nerve stimulator is gradually increased~     until the right thumb begins to twitch. A magnetic coil is placed on the scalp on one side of~     the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles~     in the opposite hand.~      If you are a control subject, and therefore will not/have not have DBS surgery, we will~     measure the body's response to TMS for comparison purposes. We expect that the electrical~     differences in the brain may be related to the physical benefits some patients with primary~     cervical dystonia receive from DBS surgery.~   "
144841|NCT01671514|"~     The major goal of this study is to characterize the ability of dark chocolate enriched in~     epicatechin (a component of dark chocolate) to improve the structural and functional features~     of mitochondria in two groups~        1. Patients with heart failure (HF) and type 2 diabetes (DM2) and~        2. Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed~          by VO2 max)~      We propose that a 3 month treatment with dark chocolate will lead to a significant~     improvement in exercise capacity which will be secondary to the improvement in skeletal~     muscle structure from epicatechin.~   "
144842|NCT01671501|"~     This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol~     screen; and examines innovative behavioral interventions, and their cost effectiveness, for~     hazardous drinking within a large HIV primary care clinic. We will compare Motivational~     Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the~     interventions on hazardous drinking, comorbid drug use, enrollment in substance use treatment~     programs, and HIV outcomes including antiretroviral therapy adherence, HIV RNA control, and~     unsafe sex. Given the well-known adverse effects of hazardous drinking on HIV care and~     outcomes, the proposed study has the potential to make a significant impact in the care of~     HIV patients.~   "
144843|NCT01671488|"~     The main purpose of this study is to study the safety and effectiveness of ADXS11-001 when~     combined with standard chemotherapy and radiation treatment for anal cancer. ADXS11-001 is an~     investigational agent that is not approved by the FDA to treat anal cancer or any other~     cancer.~   "
144844|NCT01671475|"~     The proposed study aims to test the impact of microEEG on clinical management (diagnosis and~     treatment) of emergency department patients with Altered Mental Status (AMS). The study will~     utilize a portable, wireless, FDA-approved device (microEEG) as the intervention. Patients~     will be randomized to routine care plus microEEG (experimental arm) or routine care alone~     (control arm). The investigators hypothesize that incorporating microEEG in the work up of~     patients with AMS will impact the clinical management of these patients.~   "
144845|NCT01671462|"~     The purpose of the study is to compare the results of the Becton Dickinson (BD) Human~     Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV~     diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or~     residual) and a BD cervical brush in BD transport medium to reference histology results from~     biopsy.~   "
144846|NCT01671449|"~     A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly)~     versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric~     cancer~   "
144858|NCT01671293|"~     The purpose of this study is to determine whether a multi-component remote care model~     (telephone-based) is effective to achieve the modification of unhealthy eating practices and~     increase physical activity in adults who have prediabetes and over-weight/obesity. The~     effectiveness of the remote care model will be determined with respect to the mentioned~     practices as well as anthropometric parameters (Waist circumference and Weight) and clinical~     parameters (Fasting Glucose, Triglycerides, Total Cholesterol) which are sensitive to changes~     in these habits. The counseling intervention is the core of the multi-component tele-care~     model, which also includes counseling-through text messages, supply of Educational material~     and self-monitoring equipment (pedometers and measuring tape for patients to check their~     waist circumference).~   "
144859|NCT01671280|"~     To collect the efficacy and safety information of Azithromycin IV related to their~     appropriate use in daily practice~   "
144901|NCT01670721|"~     Primary Objective:~      To evaluate the safety of aflibercept in participants with mCRC treated with~     irinotecan/5-Fluorouracil (5-FU) combination (FOLFIRI) after failure of an oxaliplatin-based~     regimen (participants similar to those evaluated in the VELOUR trial [EFC10262, NCT00561470])~     according to side effects prevention and management guidelines.~      Secondary Objective:~      To document the Health-Related Quality of Life (HRQL) of aflibercept in this participant~     population.~   "
144847|NCT01671436|"~     Major Depressive Disorder (MDD) is a serious, costly and highly prevalent condition. However,~     currently available treatment options have limited efficacy. The aim of this pilot study is~     to determine whether patients suffering from MDD who have not responded to at least one~     antidepressant trial may actively engage in a novel group therapy, Central Meditation and~     Imagery Therapy (CMIT). Preliminary results with individual patients suggest that CMIT~     techniques may have benefit for major depression. The purpose of this trial is to assess the~     feasibility of a group form of CMIT for the treatment of major depression. The trial will~     also seek to identify neurophysiological and cardiovascular predictors of treatment response.~      In this study, 10 subjects with major depressive disorder will receive antidepressant~     treatment augmentation with group meditation and mental imagery therapy for a total of 12~     weeks, as well as daily meditation practice. Group sessions will also involve gentle yogic~     stretches. The subjects will be limited to those who remain depressed despite at least one~     trial of antidepressant medication. Changes in brain activity and heart rate variability will~     be measured at three time points utilizing electroencephalography (EEG) and pulse monitors.~     Depression symptoms will be measured at several time points using questionnaires and~     objective measures. Participation will require a total of 15 visits for weekly therapy and~     the measurements. Two-month follow-up questionnaires will be mailed to the subjects after~     study end to assess durability of any improvements in depressive symptoms.~   "
144848|NCT01671423|"~     Cellulitis is the medical term for an infection of the skin, with symptoms including redness,~     swelling, warmth, and pain. This group of symptoms is called inflammation, and is caused by~     the body's immune system responding to the infection. Standard care for cellulitis is using~     antibiotics to destroy the infection, but the inflammation can persist and cause a great deal~     of pain. The hypothesis of this study is that adding a single dose of an oral steroid~     (prednisone), which tempers the immune response, will reduce inflammation, reduce pain, and~     speed recovery. This hypothesis will be examined by recruiting a group of patients with~     cellulitis, and randomizing them to two sub-groups: one group will receive a dose of~     prednisone, while the other group will receive a placebo. Neither group will know what they~     received unless there is a problem. These subjects will be followed up at the 48 hour mark~     and the 7 day mark, and will have their results compared.~   "
144849|NCT01671410|"~     The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after~     utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS.~     This trial will investigate the safety and tolerability of sublingual buprenorphine in~     infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in~     those who are breastfeeding.~   "
144850|NCT01671397|"~     The prevalence of obesity has steadily increased in the United States. This can lead to the~     worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and~     osteoarthritis. The medical management of obesity involves dietary counseling and education,~     behavioral counseling with goal setting, and exercise. Patients with short sleep periods in~     the range of 5 to 7 hours per night are often heavier than normal sleepers even after~     controlling for other factors. We hypothesize that the addition of focused counseling on~     healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help~     women lose weight.~   "
144851|NCT01671384|"~     Spinal muscular atrophy (SMA), an autosomal recessive disorder, is characterized by muscle~     weakness due to degeneration of anterior horn cells in the spinal cord and brain stem nuclei.~     It has a variable incidence of 1 in 6700 to 1 in 25000 live births and prevalence of 0.12 to~     25 per 10,000 populations in different geographic areas and genetic constitution. A~     homozygous deletion/mutation involving exon 7 in SMN1 (survival motor neuron 1) is present in~     around 95% of the cases, resulting in the biochemical deficiency of the SMN protein. A~     genomic duplication at the same locus produces nearly identical SMN2 (survival motor neuron~     2) that differs from SMN1 by a nucleotide substitution that promotes exon 7 exclusion thus~     giving rise to only a fraction of the full length protein. Phenotypic variation in SMA~     correlates with the number of SMN2 gene copies and the level of SMN protein in cells.~      Several hypotheses including defective inhibition of apoptosis, glutamate excitotoxicity and~     lack of a neurotrophic factor(s) in nerve or muscle have been speculated in the pathogenesis~     of SMA.~      Valproic acid (VPA), a histone deacetylase (HDAC) inhibitor, directly increases SMN~     expression in SMA patient-derived cell lines in vitro. Till date 3 open label trials and 1~     placebo controlled RCT of VPA in human subjects have been published, all indicating a~     possible benefit in strength and/or motor function. Till date there is no effective therapy~     for SMA. Therapy is mainly supportive and palliative which can prolong lifespan and prevent~     complications to some extent without actually curing the disease.~      Children with SMA may have a reduced capacity to synthesis carnitine consequent to~     significantly diminished skeletal muscle mass. VPA independently inhibits carnitine transport~     and its metabolites deplete carnitine levels by binding to them. So along with valproate~     these patients should be supplemented with carnitine.~      With this background the investigators have planned a double blind randomized placebo~     controlled trial of Valproate and levocarnitine in 60 children (30 each in intervention and~     control arm) with Spinal Muscular Atrophy aged 2-15 years over a 2 year period with one~     baseline and four follow up visits. The study will be conducted in the Department of~     Pediatrics, AIIMS at the Myopathy clinic.~   "
144852|NCT01671371|"~     The purpose of this study is to determine whether point-of-care (bedside) ultrasound assists~     physicians in the evaluation and management of patients with syncope.~   "
144853|NCT01671358|"~     This study is to determine if medication cabinets located outside of isolation rooms in~     hospitals and their contents, particularly medications and the delivery folders are at a~     higher risk of having harmful bacteria on them.~   "
144854|NCT01671345|"~     Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the~     prevalence of diabetes at almost 20 percent in VA patients and the prevalence of diabetes in~     the VA is higher among racial and ethnic minorities. Poorly controlled diabetes leads to a~     number of complications including cardiovascular disease, blindness, amputation, and end~     stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as~     diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care~     is related at least in part to effective communication in medical encounters. This project is~     designed to test a video intervention to improve patients' communication behaviors. Doctors~     will also receive a communication skills training program. The project will assess the impact~     of the training programs on communication and outcomes. The study is designed to help make~     patient care more patient-centered, which is one of the six aims for improvement in the IOM~     Report, Crossing the Quality Chasm and is a goal of VA transformation efforts.~   "
144855|NCT01671332|"~     The overall purpose of the study is to determine whether or not the inclusion of suramin to~     standard treatment with docetaxel improves progression-free survival for patients with~     advanced non-small cell lung cancer in the second and third line settings.~   "
144860|NCT01671267|"~     The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers,~     allegedly due to the substantial load of these body regions during work. Work disability is a~     common consequence of these pains. Lowering the physical exposure through ergonomic~     intervention may be a strategy to reduce the workload. An alternative strategy could be to~     increase the physical capacity through strength training of the shoulder-, arm- and~     hand-muscles. This study investigates the effect of two contrasting interventions, i.e. load~     reduction (ergonomic intervention) versus training of physical capacity (strength training)~     on pain and work disability in slaughterhouse workers.~      The main hypothesis is that strength training intervention for 10 weeks compared with~     ergonomic intervention results in reduced pain of the shoulder, arm and hand.~   "
144861|NCT01671254|"~     The purpose of this 8-week intervention trial is to investigate the effect of a dietary~     supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in~     healthy hyperlipidemic subjects~   "
144862|NCT01671241|"~     Hypothermia after delivery is a world-wide problem associated with morbidity and mortality.~     The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is~     unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin~     wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very~     preterm babies and represents the standard of care recommended by the International~     Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce~     heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the~     proportions of hypothermic infants at NICU admission (temperature <34°C) in the wrapped group~     (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The~     combination of body and head protection with a polyethylene wrap needs to be evaluated~     further. The investigators conducted a prospective, randomized, controlled trial in very~     preterm infants to evaluate whether a polyethylene total body wrapping (body plus head)~     prevents heat loss after delivery better than polyethylene occlusive wrapping.~   "
144863|NCT01671228|"~     The purpose of this research is to develop a patient decision aid in paper and web formats to~     help patients with chronic kidney disease make informed dialysis treatment decisions.~   "
144864|NCT01671215|"~     fibroids are common among women in fertile age. the relation between fibroids and infertility~     is controversial. our goal is to claculate a ratio between uterine cavity - endometrium &~     myometrium in normal uterine s and study the interference of the cavity in uterine s with~     fibroids.~   "
144865|NCT01671189|"~     Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation~     tool to automate appointment confirmation and rescheduling. Working in parallel with the San~     Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will~     automate reminders that request text responses from patients to either confirm or request to~     reschedule their upcoming appointments. While simple in concept, this tool aims to free up~     scarce clinical resources which are currently allocated to daily patient phone call~     reminders. With funding from a Bay Area foundation, the investigators will develop and pilot~     this open-source software tool in a 12-month randomized-controlled trial, slated to begin in~     October 2012. The endpoints of the study will aim to demonstrate improvements in both~     appointment adherence and glycemic control.~   "
144866|NCT01671176|"~     To assess implant stability, implant loss, adverse skin reactions, and Quality of Life~     Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to~     determine the feasibility of fitting the sound processor 3 weeks after surgical implantation,~     and to investigate if the type of skin reactions following implantation could be related to~     the demographic data of subjects and the type of surgical technique used~   "
144867|NCT01671163|"~     The purpose of this research study is to evaluate placing the radiation therapy markers~     (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic~     Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the~     end. The ultrasound will allow the doctor's to see where the radiation therapy markers~     (Fiducial) is to be placed as outlined by the Radiation Oncologist.~   "
144868|NCT01671150|"~     Depressive disorders occur at a high rate in patients with inflammatory disorders, with a~     point prevalence of 15-29%, which is two to three times greater than that observed in the~     general population. Substantial evidence has shown that inflammation and increases in~     proinflammatory cytokine activity play a critical role in the onset and perpetuation of~     depression and depressive symptoms (e.g. insomnia, fatigue) in those who are co-morbid for~     inflammatory disorders. Consistent with this, experimental work has shown that an~     inflammatory challenge can increase depressed mood in an otherwise healthy sample. Based on~     these findings, there has been a growing interest in whether inflammatory processes can~     contribute to depression in a causal manner and how these effects might occur.~      Given the observation that inflammatory processes trigger social withdrawal, coupled with~     evidence that feelings of 'social disconnection' play a critical role in the onset and~     perpetuation of (non-inflammatory forms of) depression, it is surprising that the social~     psychological consequences of inflammation and their contribution to depression have not been~     more fully explored. Here, we suggest that inflammation may increase feelings of social~     disconnection and that these social psychological changes may be an important contributor to~     inflammation-associated depression. Indeed, preliminary data demonstrated that an~     experimentally-induced inflammatory challenge (endotoxin) led to increases in self-reported~     feelings of social disconnection (e.g., I feel disconnected from others) in addition to~     increases in depressed mood. Aside from these findings, however, there are no studies that~     have explored the effect of inflammatory processes on social experience in humans. The~     over-arching objective of this proposal is to explore the experiential and neural correlates~     of inflammatory-induced changes in social experience (e.g., feelings of social~     disconnection), which may provide a critical missing link in understanding the relationship~     between inflammation and depression.~      Participants (n=100) will be randomly assigned to receive either endotoxin or placebo and~     will then be monitored for the next six hours. Blood draws to assess cytokine levels as well~     as self-reported feelings of social disconnection and depressed mood will be collected~     hourly. In addition, at the time of peak cytokine response, participants will complete a~     neuroimaging session to examine the effect of inflammatory challenge on neural sensitivity to~     social rejection and social acceptance. It is hypothesized that endotoxin will increase~     feelings of social disconnection over time, and that the underlying neural sensitivities that~     give rise to these feelings (e.g., increased neural sensitivity to social rejection;~     decreased neural sensitivity to social acceptance) will contribute to inflammatory-induced~     depressed mood.~   "
144869|NCT01671137|"~     The present study has several aims:~        1. Establish whether Lactobacillus Rhamnosus Strain GG is able to prevent the onset of IBS~          in a high risk group of children enrolled after an acute gastroenteritis (the study has~          been powered to this aim).~        2. Establish whether Lactobacillus Rhamnosus Strain GG is able to stabilize the intestinal~          microbiota after an acute gastroenteritis.~        3. Define the intestinal microbiota of children following an acute gastroenteritis and~          identify, if possible, a modification of the microbiota that can predict the emergence~          of Irritable Bowel Syndrome.~   "
144928|NCT01670370|"~     The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and~     Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with~     DLBCL~   "
144929|NCT01670357|"~     This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared~     with placebo in dry eye syndrome.~   "
144870|NCT01671124|"~     Considering the potential modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang~     supplementation on mood, this study is a clinical study of Soline® (product mixed with Salvia~     divinorum, Lycium, Chenpi and Dihuang ) supplementation to investigate the effect of~     attenuating the occurrence of depression. The study will enroll 100 patients who meet the~     inclusion and exclusion criteria. The trial will be concluded when a total of evaluable 80~     patients (40 patients in each treatment group).~   "
144871|NCT01671111|"~     The purpose of this extension study is to evaluate SSP-004184AQ in patients with~     transfusional iron overload and to provide data on long term safety and efficacy.~      SSP-004184AQ is an iron chelator under development for chronic daily oral administration to~     patients with transfusional iron overload~   "
144872|NCT01671098|"~     Sinonasal gas exchange is facilitated by the unique anatomy and topography of the sinonasal~     interface that represents a collection of airfoils creating an aerodynamic structure. The~     airflow during respiration generates positive and negative pressures that power the gas~     exchange between the sinuses and the nose. Major surgical alteration of the interface reduces~     the rate and velocity of the exchange. Minimally invasive procedures aimed at preserving the~     natural anatomy, topography and aerodynamic configuration of the interface will have~     negligible effects on sinonasal gas exchange.~   "
144873|NCT01671085|"~     This is a study in healthy participants with high levels of bad cholesterol who are already~     taking a popular type of cholesterol-lowering medication called statins. Following multiple~     doses of LY3015014, investigators will study the safety and tolerability of the drug, how the~     body handles the drug, and the drug's effect on the body. Participants will remain in the~     study for about 3 months, not including screening. Screening is required within 28 days~     before the study starts.~   "
144874|NCT01671072|"~     The purpose of this study is to determine whether TissueGene-C, an allogeneic human~     chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients~     with degenerative arthritis~   "
144875|NCT01671059|"~     This non-interventional study evaluated the use and efficacy of tocilizumab~     (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis. Eligible~     participants initiated on tocilizumab treatment according to the approved label were followed~     for 6 months.~   "
144876|NCT01671046|"~     This multi-center, prospective observational study will evaluate the correlation of liver~     biopsy and transient elastography in liver fibrosis assessment in patients with chronic~     hepatitis C. Data will be collected for 96 weeks.~   "
144877|NCT01671033|"~     From the scarce literature it showed that computer/internet-aided cognitive behavior therapy~     (CBT) was superior to waitlist and placebo assignment across outcome measures, and the~     effects of computer/internet-aided CBT were equal to therapist-delivered treatment across~     anxiety disorders. The aim of this study is to evidence the effectiveness of internet-based~     relaxation with biofeedback treatment for panic disorder.~   "
144878|NCT01671020|"~     Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and~     single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb®~     tablet (fimasartan) in healthy subjects~   "
144879|NCT01671007|"~     In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at~     risk for stroke are enrolled to characterize the target population and to collect real world~     data on important outcome events. For administrative purposes the study is divided into two~     protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area)~     countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in~     both protocols is estimated to be 48,000 patients, and all these patients will be included in~     the data analysis for study 1160.129.~   "
144880|NCT01670994|"~     This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801~     in patients who have relapsed or refractory multiple myeloma.~   "
144881|NCT01670981|"~     This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T~     compared to placebo (vehicle control) when administered via transendocardial catheter-based~     injections to patients with end stage heart failure due to IDCM, who have no reasonable~     revascularization options (either surgical or percutaneous interventional) likely to provide~     clinical benefit.~   "
144882|NCT01670968|"~     Primary Objective:~      To examine changes in expression of genes [particularly ABCA1 and SREBP2] involved in reverse~     cholesterol transport (RCT) in monocytes from HIV-infected subjects starting antiretroviral~     therapy and the different effect of NNRTI and PI based regimens~      Secondary Objective:~      To examine changes in monocyte intracellular cholesterol content in HIV-infected subjects~     starting antiretroviral therapy and the different effect of NNRTI and PI based regimens~   "
144883|NCT01670955|"~     PROTOCOL FOR THE STUDY OF THE SAFETY AND EFFICACY OF JOBELYN, IN THE PREOPERATIVE MANAGEMENT~     OF ANAEMIA IN GYNAECOLOGICAL PATIENTS~   "
144884|NCT01670942|"~     The purpose of this research is to see if people who have had a collapsed lung that has been~     re-expanded can be safely taken to an elevation that a person might experience while in a~     commercial airplane without having their lung partially collapse again, or have any symptoms~     such as feeling short of breath or having oxygen levels in the blood decrease while at the~     simulated altitude.~      The investigators hypothesize that subjects who have had a collapsed lung that has been~     re-expanded will not have any adverse symptoms or signs while subjected to a simulated~     altitude of 8400 feet (565mm Hg) or 12650 ft (471mm Hg).~   "
144885|NCT01670929|"~     In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice~     daily), started soon as possible at luteal phase and after a positive pregnancy test and~     continued to 28 weeks of gestation, compared to placebo, ).~   "
144886|NCT01670916|"~     Probiotics is given routinely to infants admitted to the department of neonatology during the~     first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence~     of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical~     records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1~     March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009~     will be compared.~   "
144930|NCT01670344|"~     This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative~     positioning system in the clinical setting of orthopedic surgery.~      Aim of the study is the validation and comparison of the innovative medical device with the~     current standard method.~   "
144887|NCT01670903|"~     Abdominal aortic aneurysm (AAA) is a common disease that develops from degeneration of the~     aortic wall. The natural history of AAA is gradual expansion and if left untreated may result~     in rupture and death. The mechanism of the development of this disease is unknown however it~     appears to be multifactorial and possibly related to degradation processes within the~     arterial wall. There is growing evidence that Angiotensin receptor blockers ( ARBS) may have~     an inhibitory effect on remodelling processes within the arterial wall, thus inhibiting~     degeneration of the vessel wall.~      Study hypothesis: ARBS are associated with smaller diameters of aortas among hypertensive~     patients, and are associated with a lower rate of aortic expansion compared to other~     antihypertensive drugs.~   "
144888|NCT01670890|"~     Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant~     gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ.~     Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment~     procedure has not been established yet.~      The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of~     TMZ and CDDP in patients with recurrent malignant gliomas~   "
144889|NCT01670877|"~     This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how~     HER2 mutated cancer responds to treatment with neratinib.~   "
144890|NCT01670864|"~     Background According to the report of Census & Statistics Department, there are still 659,300~     daily smokers (11.1%) in Hong Kong and smoking kills over 7,000 people per year. The Quit and~     Win programme provided another opportunity to reach large group of smokers, and it aims to~     widespread quit attempts among smokers via incentives in order to boost up the number of~     quitters. Although such competitions appear to reach large cohorts of smokers, there is still~     insufficient evidence of its effectiveness in helping smokers to achieve complete cessation.~      Aim This project aims to promote and evaluate community-based smoking cessation services~     through the Quit to Win Contest organised in the 18 districts of Hong Kong. The specific~     objectives of the study are (1) to build capacity in the community on smoking cessation~     through a training programme; (2) to empower the participated NGOs (a) to raise the awareness~     of smoking cessation in the community level; (b) to reach as many smokers as possible; (c) to~     arouse the interest of smokers to quit, through organizing the Quit to Win Contest; (3) to~     test the effectiveness of community-based on-site face-to-face counselling and Short Message~     Service (SMS) message vs. self-help booklet to assist current smokers to quit smoking; and~     (4) to build-up a community-based participatory research (CBPR) model in smoking cessation~     intervention at a district level in Hong Kong.~      Methods A community-based participatory (CBP) approach, which is an effective way to engage~     public health researchers and community members (NGOs, other major stakeholders, and~     participants), will be used. Two domains of outcome will be assessed: (1) Effectiveness of~     smoking cessation interventions, (2) process evaluation of the recruitment activities~     including number of eligible participants and amount of publicity.~      Procedure At the recruitment sites, after screening for eligibility of participants for the~     Quit to Win Contest, smoking counselor will measure eligible participant's level of carbon~     monoxide (CO) on expired air, and provide the self-help smoking cessation materials developed~     by the Hong Kong Council on Smoking and Health (COSH). Then the counselor will explain and~     invite the participants to join the cluster randomized controlled trial on smoking cessation~     intervention. Participants will be allocated to one of the groups of the smoking cessation~     intervention. 3- and 6-month follow-ups will be conducted~      Hypothesis We hypothesize that the on-site brief smoking cessation advice will lead to~     significant increases in rates of smoking cessation in the intervention group than the~     control group (with the self-help materials only). Another hypothesis to be tested is that~     the intervention of sending SMS messages of smoking cessation advice is effective to increase~     the quit rate comparing to the control group.~   "
144891|NCT01670851|"~     This is a prospective, multicenter, single arm, observational pilot study to assess the~     clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction~     following eLAPE and simultaneous stoma reinforcement.~   "
144892|NCT01670838|"~     This is a prospective cohort study investigating cardiac function and cardiac biomarkers in~     patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to~     document the incidence of myocardial dysfunction,to find the predictive factors of myocardial~     dysfunction, describe heart rate variability and to assess the impact of all cardiac problems~     on morbidity and mortality.~   "
144893|NCT01670825|"~     The aim of this study is to determine whether pulsed radiofrequency or steroids are better~     for occipital neuralgia. Seventy-six patients with ON or migraine with tenderness over the~     occipital nerve who respond to occipital nerve blocks (hereafter included under the broad~     category ON) will be randomized in a 1:1 ratio to receive either corticosteroid and local~     anesthetic injections (n=38) or local anesthetic and PRF of the occipital nerve(s) (n=38) for~     occipital neuralgia. Both patients and the treating & evaluating physicians will be blinded.~     The first follow-up visit will be at 6 weeks. Patients who obtain significant pain relief~     will remain in the study. Those patients who fail to obtain any benefit will exit the study~     and be allowed to crossover to the other treatments or receive alternative care. The second~     follow-up will be at 3 months and the final follow-up will be at 6-months post-procedure.~   "
144894|NCT01670812|"~     The purpose of this study is to investigate efficacy and safety of fresh frozen plasma(FFP),~     high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic~     leukemia.~   "
144895|NCT01670799|"~     The purpose of this study is to evaluate the anti-cancer effect of a pain medication called~     ketorolac (Toradol) on ovarian cancer cells in the abdominal (peritoneal) cavity after~     surgery for ovarian, fallopian tube or primary peritoneal cancer.~   "
144896|NCT01670786|"~     Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural~     effusion, with minimal adverse events, especially reducing dose.~   "
144897|NCT01670773|"~     This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy~     humans.~   "
144898|NCT01670760|"~     The core temperature of the body normally decreases in response to anesthesia. Deep tissue~     temperature can be used to estimate of body core temperature. Deep tissue temperature of the~     forehead will be measured using a new technology known as zero-heat-flux thermometry. The~     usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal~     temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously~     during surgery and compared for agreement. The hypothesis of this trial is that deep tissue~     temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal~     temperatures during surgery.~   "
144899|NCT01670747|"~     In this study gas-exchange and respiratory mechanics variations to PEEP change will be~     correlated to CT lung morphological modifications assessed at different airway pressures (5,~     15, 30 and 45 cmH2O).~   "
144900|NCT01670734|"~     Primary Objective:~      Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab~     SAR236553 (REGN727).~      Secondary Objectives:~        -  Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with~          mild and moderate hepatic impairment and in matched subjects with normal hepatic~          function.~        -  Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with~          hepatic impairment and in matched subjects with normal hepatic function.~   "
144902|NCT01670708|"~     The purpose of the Multisite Evaluation of the Honest Opportunity Probation with Enforcement~     Demonstration Field Experiment (the HOPE DFE Evaluation) is to conduct a randomized control~     trial (RCT) replication of the original Hawaii HOPE program and evaluation. The HOPE program~     provides strict oversight of probationers through a HOPE Court judge and intensive probation~     supervision, including random drug testing, coupled with swift and certain sanctions in~     response to positive results on random drug tests and other violations of conditions of~     supervision. The HOPE DFE Evaluation is being conducted among probation populations in four~     sites and will identify the effectiveness of swift and certain sanctions on targeted~     outcomes, both primary (appointment no-shows, positive urine tests, re-arrest rates) and~     secondary (revocation rates, jail days served, prison days sentenced).~   "
144903|NCT01670695|"~     This is an cohort study to investigate the disease course and treatment response of patients~     with IgG4-related disease.~   "
144904|NCT01670682|"~     Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous~     fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh~     are both developed in China for vaginal apex fixation, the former is native tissue repairs,~     and the latter is augmentation with mesh.~      This study is designed to determine the effectiveness and safety of ischia spinous fascia~     fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh~     for the treatment of pelvic organ prolapse stage III.~      Patients enrolled into the study will be followed up for up to 3 years after surgery.~     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before~     and after surgery, patient satisfaction through quality of life and sexual function~     questionnaires before and after surgery, and peri-operative complication rates will be~     evaluated.~   "
144905|NCT01670669|"~     The purpose of this study is characterize the efficacy, safety, tolerability, and~     steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a~     solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal~     retention (FFR) for 8 weeks.~      Hypothesis:~      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the~     adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the~     adult profile.~   "
144906|NCT01670656|"~     The study investigates four vaginal ring groups with respect to relief of primary~     dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant~     treatment efficacy in relief of primary dysmenorrhea.~   "
144907|NCT01670643|"~     The most common goal for patients with vision loss who present for vision rehabilitation is~     to be able to read. The video magnifier (a device which combines a video camera and a screen~     to view the print being magnified) is the device which most often allows low-vision~     individuals to read successfully for extended periods of time. Previous studies on the~     outcomes of vision rehabilitation have not identified which components of the vision~     rehabilitation are effective. The hypothesis of this project is that providing a video camera~     magnifier, with basic training in operating the device, will allow patients to enhance both~     objective reading ability and subjective report of reading competence.~   "
144908|NCT01670630|"~     The purpose of this study is to estimate if a novel sheathed speculum provides improved~     visualization of the cervix compared to a standard (non sheathed) speculum, and to estimate~     if the sheathed speculum causes less discomfort during the examination.~   "
144909|NCT01670617|"~     The purpose of this study is to evaluate the long-term relief of pain and return to function~     for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed~     product and has been used in more than 7,500 patients over the last 7 years.~   "
144910|NCT01670604|"~     This study compares the effect of infusion of two types of modern hydroxyethyl starch on the~     renal function and acid-base in patients undergoing urologic surgery.~   "
144911|NCT01670591|"~     Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the~     universal prevention level, developed by Swedish researchers for the school years 4 -9. By~     defining and teaching school rules to all teachers and students, and by consistently~     acknowledging students when meeting behavioural expectations, the program aims to reduce~     problem behaviours in school areas and to improve the classroom learning climate. Against~     this background, the purpose of this study is to examine whether PS is more effective than~     schools' ordinary practices in meeting these goals.~   "
144912|NCT01670578|"~     The investigators hypothesized that intra-articular injections of Platelet-rich Plasma (PRP)~     to treat knee degenerative articular cartilage pathology could determine pain relief and~     recovery of knee function with overall clinical outcome comparable or even better than~     viscosupplementation, which is a common injective approach applied in this kind of pathology.~     To this purpose the investigators designed a double blind randomized controlled trial~     comparing PRP vs viscosupplementation.~      A power analysis has been performed for the primary endpoint of IKDC (International Knee~     Documentation Committee) subjective score improvement at the 12-month follow-up for PRP. From~     a pilot study, a standard deviation of 15.2 points was found. With an alpha error of 0.05, a~     beta error of 0.2 and a minimal clinically significant difference of 6.7 points corresponding~     at 1/3 of the documented mean improvement, the minimum sample size was 83 for each group.~     Considering a possible drop out of 15%, 96 patients per group are required for total 192~     patients, selected according to well-defined inclusion criteria (see 'Eligibility criteria'~     section). Patients are then assigned to two different treatment groups, according to a~     randomization list. The first group of treatment consists of three weekly intra-articular~     injections of autologous PRP obtained with the following procedure: a 150-ml autologous~     venous blood sample undergoes 2 centrifugations (the first at 1480 rpm for 6 minutes to~     separate erythrocytes, and a second at 3400 rpm for 15 minutes to concentrate platelets) to~     produced 20 ml of PRP. This unit of PRP is then divided into 4 small units of 5 ml each. One~     unit is sent to the laboratory for analysis of platelet concentration and for a quality test,~     3 units are stored at -30° C.~      The second treatment group consists of patients receiving three weekly injections of~     hyaluronic acid (Hyalubrix 30 mg/2ml, Fidia Farmaceutici Spa, Italy;Molecular Weight: 1500~     kDa).~      To guarantee the blinding of the patients, all of them undergo blood harvesting to obtain~     autologous PRP which will be used only in half of them, according to the aforementioned~     randomization list. One week after the PRP production, the injective treatment starts, with 3~     weekly injections of PRP or HA. At the moment of the injection the syringe is properly~     covered to prevent the patient from discovering the substance he was receiving. After the~     injection, patients are sent home with instructions to limit the use of the leg for at least~     24 h and to use cold therapy/ice on the affected area to relieve pain. During this period,~     the use of non-steroidal medication is forbidden.~      Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using~     clinical subjective scores and objective parameters to determine clinical outcome (see~     'Outcome measure' section). Patient satisfaction and adverse events will be also reported.~     All the clinical evaluations are performed by a medical staff not involved in the injective~     procedure, in order to keep the study double blinded. At the end of the study, the nature of~     the injected substance is revealed to the patients.~   "
144913|NCT01670565|"~     This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled,~     proof-of-concept pilot study. All participants will first be treated with mycophenolate~     mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half~     will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early~     diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity~     measured by an improvement in skin thickening and stability of pulmonary function test~     measurements when compared to patients treated with placebo/MMF.~   "
144914|NCT01670552|"~     The purpose of this study is to evaluate the safety of an association with one~     anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and~     one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.~   "
144915|NCT01670539|"~     The purpose of this study is to learn more about using a home machine Telemonitor to find~     problems people with lung cancer may have after being discharged from the hospital and help~     them manage problems by contacting their healthcare provider.The study hypothesis is that~     patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses~     on telemonitor data risks/implications for the first two weeks after hospital discharge, will~     be able to self-report their signs/ symptoms to the clinician resulting in decreased use of~     costly health care resources over 60 days.~   "
144931|NCT01670331|"~     Is it feasible to perform a randomized controlled trial to assess whether or not~     psychological preparation seminars prior to bariatric (weight loss) surgery are beneficial to~     the investigators patients?~   "
145328|NCT01665144|"~     Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment~     duration in patients with secondary progressive multiple sclerosis (Core Part) followed by~     extended treatment with open-label BAF312 to obtain data on long-term safety, tolerabiilty~     and efficacy (Extension Part).~   "
144916|NCT01670526|"~     Difficulties with intellectual functioning, particularly memory functions, are common and~     source of long-term disability after Traumatic Brain Injury (TBI). However, there is very~     little information about pharmacologic (i.e., medication) treatments targeting these~     deficits. There are growing data showing brain abnormalities in acetylcholine, the chemical~     system that manages memory, in TBI. These findings provide the rationale for the use of~     cholinesterase inhibitors, medications that modulate this system, in TBI patients. As the~     prevalence of TBI among Veterans of recent military conflicts increases, becoming a~     signature injury of the Iraq and Afghanistan conflicts, it is of utmost importance to the~     Veterans Health Administration to collect scientific data on the efficacy of pharmacological~     treatments for intellectual difficulties in TBI patients. This study will evaluate the~     effects of the cholinesterase inhibitor rivastigmine transdermal patch in Veterans with TBI~     and posttraumatic memory problems. Results will provide much needed data that will help treat~     Veterans with TBI.~   "
144917|NCT01670513|"~     Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area~     affected will be enrolled in the study.~   "
144918|NCT01670500|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well~     it works in treating a specific cancer. Investigational means that cisplatin is still being~     studied for use in this setting and that research doctors are trying to find out more about~     it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation~     carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer.~     Cisplatin has been approved by the FDA for treatment of other cancers.~      The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown~     to be active in the treatment of women with breast cancer and a BRCA mutation. In this study,~     we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide~     (AC) that you might receive if you did not participate in this study.~   "
144919|NCT01670487|"~     To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in~     decreasing the pain of intravenous cannulation.~      To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water)~     stream.~   "
144920|NCT01670474|"~     Surface thrombogenicity of standard double lumen catheters (stDLC) and surface modified~     film-coated domain structured double lumen catheters (fcDLC) consisting of a novel reactive~     polyurethane copolymer coating showed that in vitro measured surface thrombogenicity was~     reduced in the modified catheter compared with standard catheter. The clinical investigation~     revealed that both number of days before catheter removal according to clinical requirements~     and number of treatments per catheter were significantly higher with the modified catheter as~     compared with the standard catheter.~      Recombinant tissue plasminogen activator (rt-PA) has been used primarily to treat catheter~     thrombosis. The relatively high cost of rt-PA and its theoretical potential to cause~     bleeding, as well as the morbidity and mortality associated with catheter malfunction and~     infection, justify the need for more definitive evidence of the efficacy of rt-PA as a~     locking solution.~      No study aims to evaluate the impact of rt-PA locking in long-term Hemodialysis (HD) uncuffed~     catheters survival.~   "
144921|NCT01670461|"~     Advance Care Planning (ACP) prepares patients and their loved ones for future health care~     decisions, including end-of-life decisions. Yet, the needs of adolescent oncology patients~     for participation in ACP, despite its priority, is not well studied. Our goal is to test a~     model of ACP that anticipates these issues, fully empowers the family and adolescent, and~     keeps the key role of health care professionals central, building on our earlier work. We~     hypothesized FAmily CEntered (FACE) ACP, would: (1) increase congruence in treatment~     preferences between adolescents and surrogates; (2) decrease decisional conflict for~     adolescents; and (3) increase quality of communication compared with controls.~   "
144922|NCT01670448|"~     Pain after breast cancer surgery could be severe and about 1/3 of patients will develop~     chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral~     muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of~     this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor~     and major breast surgery. The prevention of chronic pain following surgery will also be~     evaluated.~   "
144923|NCT01670435|"~     This study is a post-marketing surveillance in Japan, and it is a local prospective and~     observational study of patients who have received Ciproxan intravenously as a first-line~     treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical~     or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective~     of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A~     total of 3,000 patients are to be enrolled and assessed during the period of treatment with~     Ciproxan.~   "
144924|NCT01670422|"~     Clinically, recurrence and life-threatening complications are challenging problems for~     chronic suppurative osteomyelitis of the jaw. There is no quantitative analysis or report~     about the causes of or risk factors for the two problems. Doctors identify the causes or risk~     factors only through clinical experience. The investigators performed a retrospective study~     of 322 patients with chronic suppurative osteomyelitis of the jaw. The risk factors for the~     above mentioned two problems were analyzed by logistic regression analysis. The investigators~     found that some of the patients' general conditions, including age, admission temperature,~     admission white blood cell count, pre-admission antibiotic administration without~     consultation, location of the lesion, and general patient condition, were the risk factors.~     The results indicate that doctors should be mindful of those risk factors and that the~     management should be more aggressive when the above risk factors are present.~   "
144925|NCT01670409|"~     The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year~     local control and overall survival rates in patients with esophageal squamous cell carcinoma~     receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.~   "
144926|NCT01670396|"~     The investigators hypothesized that genetic variants of G protein influence the development~     of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).~   "
144927|NCT01670383|"~     The objective of this study is to find a new therapeutic strategy by investigating the serial~     serum samples of patients with sepsis or postresuscitation state.~   "
144932|NCT01670318|"~     Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium~     everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the~     identical antiproliferative agent and polymer but with a novel platinum chromium scaffold~     designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity,~     radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex~     coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left~     main trunk disease, and small vessel diseases is still unknown.~   "
144933|NCT01670305|"~     Residual pockets and furcation defects are challenging sites that require additional~     periodontal therapy. The aim of this study is evaluate 1)the effect of a single photodynamic~     therapy (PDT) as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT~     in association with scaling and root planing (SRP) in class II furcation lesions with probing~     pocket depth (PPD) >5mm and bleeding on probing (BoP). A blind randomized controlled clinical~     trial was conducted in subjects presenting at least three residual pockets in single root~     teeth and subjects with at least one molar presenting class II furcation defect. To evaluate~     the effect of a single PDT as monotherapy in residual pockets, the selected sites were~     assigned to receive: PDT alone, photosensitizer alone or SRP alone. To evaluate the effect of~     PDT in association with SRP in class II furcation lesions, the selected sites were assigned~     to PDT+SRP or SRP alone. Clinical, microbiological and immunoenzymatic analyses were assessed~     at baseline, 3 and 6 months post-therapies.~   "
144934|NCT01670292|"~     This is a biomechanical study which is Project 1 in the Developmental Center for Clinical and~     Translational Research in Chiropractic (DCRC I) (NIH/NCCAM grant 1 U19 AT004663-01; principal~     investigator Christine Goertz, DC, PhD). This study is designed to monitor both physiological~     and patient self-report outcome variables. In addition, as there is little quantitative~     information on Spinal Manipulation Technique procedures reported in clinical trials, the~     study is designed to collect preliminary kinetic measures of the spinal manipulation~     technique delivery (i.e. force-time profiles).~   "
144935|NCT01670279|"~     The purpose of this study is to assess the safety and tolerability of ascending multiple oral~     doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.~   "
144936|NCT01670266|"~     The primary objective of this study is to evaluate the safety and tolerability of 3 planned~     doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension~     (OHT) or mild open angle-glaucoma (OAG).~      The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the~     pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its~     tolerability following morning and evening dosing.~   "
144937|NCT01670253|"~     The primary objective is to investigate whether intake of approximately 200 ml of sugary~     fluid 2 hours before the scheduled gastroscopy of the abdomen can reduce the discomfort of~     fasting period for patients without reducing the quality of the study.~      Current standard for fasting and fluid intake before gastroscopy is completely fasting 6~     hours before the study. Studies in patients in general anesthesia has been found that it does~     not increase the risk of aspiration of stomach content during the operation by allowing the~     patient to drink up to 2 hours prior to anesthesia induction. There are no studies that have~     examined the quality gastroscopy using this fasting procedure. Some studies show that intake~     of sugary liquids do not have significant effect on gastric emptying.~      There are not deemed to be ethical problems with this study, as it seeks to show that a more~     lenient standard procedure in endoscopy is as safe as the established. The study is~     considered safe.~   "
144938|NCT01670240|"~     This study wants to investigate the efficiency of biological treatment for chronic pouchitis.~     Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It~     is examined in patients with ulcerative colitis.~      The primary objective evaluation is to evaluate the clinically effect of biological therapy~     (adalimumab) in patients with chronic pouchitis.~      Secondary objective is to evaluate the effect of biological therapy on the endoscopical and~     histological inflammatory activity.~      It is a double-blinded randomized placebo controlled study.~   "
144939|NCT01670227|"~     The purpose of this study was to determine whether ParentCorps promotes academic achievement~     and prevents mental health problems in children living in disadvantaged urban communities~   "
144940|NCT01670214|"~     Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of~     migraine or decrease them even in the patients with refractory migraine.~   "
144941|NCT01670201|"~     The investigator will identify the test donor site and test location will be considered on~     the upper anterior thighs as being the most suitable if available. Circumferential donors~     will be considered acceptable as well.~      Treatment will be initiated in the operation room following debridement and split thickness~     grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and~     dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked~     lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be~     applied directly to study site. Secondary dressing will include covering with ace wrap.~      Healing should be asses after 10-14 days.~   "
144942|NCT01670188|"~     The purpose of this study is to see if a compression device on the arm where a peripherally~     inserted central catheter (PICC) line has been inserted can prevent the formation of a blood~     clot around the PICC line.~   "
144943|NCT01670175|"~     This is a Phase I study of the combination of three drugs: sirolimus, cyclophosphamide, and~     topotecan. This is the first study to evaluate the safety and clinical activity of the~     combination of oral sirolimus, oral cyclophosphamide and oral topotecan in pediatric and~     young adult patients with relapsed and refractory solid tumors.~      In this phase I study, the mTOR inhibitor sirolimus will be administered in combination with~     oral cyclophosphamide and oral topotecan to children with relapsed or refractory solid~     tumors. The primary aim of this study is to recommend a phase II dose schedule and describe~     the toxicity of this combination. Myelosuppression will be a targeted toxicity.~   "
144944|NCT01670162|"~     The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept~     injection in a population of neovascular AMD patients that have been previously treated with~     2.0 mg ranibizumab for persistent PEDs.~   "
144945|NCT01670149|"~     Clostridium difficile associated diarrhoea is an important cause of morbidity in patients~     treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of~     initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a~     poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. We plan to~     carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin given~     in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.~   "
144946|NCT01670136|"~     The purpose of this study is to learn more about the safety and dosing of sildenafil in~     infants.~   "
144947|NCT01670123|"~     This three-year intervention development proposal is submitted to the NIMH DATR Mood~     Disorders/Sleep Disorders Program A2-AID and is led by a New Investigator. The goal of this~     study is to further develop and then evaluate the clinical utility of a new personalized~     smart-phone intervention to enhance illness self-management in people with bipolar disorder.~     Bipolar disorder is a heterogeneous fluctuating condition and a leading source of disability.~     Consistent with NIMH Strategic Aim 3.2, self-monitoring tools are vital to clinical~     management and evidence-based psychosocial interventions for bipolar disorder. Practice~     guidelines state that all patients should receive education in self-monitoring and~     identifying adaptive responses to early warning signs and symptoms. Advances in technology~     have enabled electronic monitoring of patient-reported outcomes using mobile devices - an~     assessment strategy called Ecological Momentary Assessment (EMA). Using freely available~     software, we have developed a preliminary version of a novel smart-phone intervention that~     integrates EMA with brief psychosocial intervention designed for people with bipolar~     disorder. Mobile real-time interventions have been successfully applied in other chronic~     illnesses and have theoretical advantages over clinic-based interventions in motivating and~     cuing health-protective behavior. Our new intervention is called Personalized Real-Time~     Intervention for Stabilizing Mood (PRISM), and it delivers tailored intervention content~     naturalistically at the moment that symptoms occur. We recently conducted a small~     proof-of-concept study of PRISM in outpatient adults with bipolar disorder that suggests the~     intervention is feasible, presents no technological or operational barriers, yields data that~     corresponds with clinical ratings, and is perceived as useful by participants. Building from~     our preliminary work, we propose to further develop the intervention based on participant~     feedback and theoretically-driven enhancements. We will then conduct a randomized trial to~     assess the clinical utility of this new intervention over 12 weeks. Specifically, we will~     randomize a sample of 90 adults aged 18 and older with Bipolar Disorder I or II to one of two~     experimental conditions. Participants in both conditions will participate in two in-person~     sessions adapted from an evidence-based psychosocial intervention for bipolar disorder, aimed~     at identifying early warning signs and adaptive responses to symptom fluctuations. The~     Control condition will participate in the in-person sessions, and the PRISM condition will~     also utilize the smart phone device for 12 weeks. In this pilot trial, we will compare~     outcomes between the two conditions on standard clinical ratings of depressive and manic~     symptoms, along with psychosocial functioning. We will assess predictors of compliance and~     changes in outcomes in the PRISM condition to inform a larger effectiveness trial. We will~     use exploratory analyses to further refine the intervention, including capitalizing on the~     rich repeated measures obtained by the device. This study will provide a strong basis for a~     larger effectiveness trial, along with a potentially useful tool to enhance self-management~     in bipolar disorder. PUBLIC HEALTH RELEVANCE: Bipolar disorder is a leading cause of~     disability, and many people do not have access to evidence-based psychosocial interventions.~     Mobile devices may prove more effective than clinic-based interventions, because they deliver~     self-management strategies at the moment that symptoms occur. To lead to a larger~     effectiveness study, we propose to further develop our novel intervention uses mobile~     technology to monitor and intervene with symptoms in real-time, and then conduct a 12-week~     randomized trial in 90 patients to evaluate the acceptability and short-term efficacy of our~     smart-phone based intervention for bipolar disorder.~   "
144948|NCT01670110|"~     The purpose of this study is to compare SOM230 treatment to placebo. The investigators will~     also assess the efficacy and safety of SOM230 in reducing total liver volume and improving~     quality of life.~   "
144949|NCT01670097|"~     The goal of this clinical research study is to learn if dexamethasone can help reduce~     shortness of breath in cancer patients. Researchers also want to learn if it can help to~     improve lung function and quality of life. In this study, dexamethasone will be compared to a~     placebo.~      Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help~     patients with shortness of breath.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
144950|NCT01670084|"~     In this study researchers want to find out more about the side effects of a new drug for~     Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic~     myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to~     nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD~     is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin~     (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for~     patients with cluster of differentiation [CD]20 positive disease). Researchers don't know all~     the ways that this drug may affect people~   "
144951|NCT01670071|"~     The purpose of this study is to compare the effect of oral paliperidone extended-release and~     oral risperidone immediate-release on cognitive function, especially the category fluency of~     Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0), in patients with an~     established diagnosis of schizophrenia.~   "
144952|NCT01670058|"~     -  The prevalence of Belatacept use~        -  The characteristics of Belatacept users and the temporal trends in these characteristics~        -  Characteristics of adult kidney-only transplant recipients who are treated with~          Belatacept vs. who are treated with Calcineurin inhibitors (CNI)-based regimens at the~          time of transplantation, and the temporal trends in these characteristics during 7 years~          post approval of Belatacept.~   "
144953|NCT01670045|"~     This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra~     (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients~     initiated on RoActemra/Actemra treatment according to the licensed label will be followed for~     6 months.~   "
144954|NCT01670032|"~     This study will be a multicenter, randomized, vehicle controlled, parallel, group, double~     blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to~     one of four treatment groups: 1.5% CD07223 Topical Gel applied BID; 1.5% CD07223 Topical Gel~     applied TID; Vehicle Topical Gel applied BID;Vehicle Topical Gel applied TID. All treatments~     will be administered for 7 days. Disease activity for the Target Lesion will be evaluated~     using the Skin Infection Rating Scale (SIRS) Score.~   "
144955|NCT01670019|"~     This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing~     antidepressant treatment in patients with major depression who have not had a complete~     therapeutic response to treatment with the antidepressant alone.~      The investigators hypothesize that added asenapine will produce greater reductions in~     depression than will added placebo.~   "
144956|NCT01669993|"~     The purposes of the study are to identify 1) the patient (demographic and clinical) and~     health care system factors predictive of immediate and late postoperative adverse outcomes in~     children undergoing tonsillectomy. 2) Evaluate the preoperative use of the sleep~     questionnaire to identify children at risk for immediate and late postoperative adverse~     outcomes in children undergoing tonsillectomy.~   "
144957|NCT01669980|"~     This is a study of safety and effectiveness of ceftaroline fosamil in children with~     Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.~   "
144958|NCT01669967|"~     Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic~     pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is~     good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the~     management of neuropathic pain in the short term - up to six hours.~   "
144959|NCT01669954|"~     The purpose of this study is to determine the bone mineral density in male and female~     patients with HIV infection according to age groups.~      This will enable a practical approach to screening for osteoporosis and the management and~     prevention of fragility fractures in people with HIV.~      In addition, all risk factors commonly associated with fragility fractures and osteoporosis~     are collected, as is HIV drug history.~      Hence, as secondary outcomes, the associations with reduced bone mineral density can be~     ascertained.~   "
144960|NCT01669941|"~     Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of~     maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy~     (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals~     in the second and third trimesters of pregnancy irrespective of the presence of malaria~     parasitemia, is currently recommended for HIV-negative women in all areas with stable~     moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer~     used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be~     decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for~     IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy~     (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care~     (FANC) with treatment of women who screen positive.~      The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a~     reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an~     area with decreasing malaria transmission and high levels of SP resistance in Kenya.~   "
144961|NCT01669928|"~     A randomised crossover trial of anti-hypertensive medication dosing regimen in effective~     blood pressure control.~      To investigate whether there is a difference in 24 hour blood pressure (BP) control when~     antihypertensive medications are taken in the morning compared with the evening. The~     identification of any significant difference could lead to more effective therapeutic~     management of arterial hypertension, which in turn would result in a reduced cardiovascular~     burden, lower costs and a better quality of life for hypertensive patients.~   "
144962|NCT01669915|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial~     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among participants in VITAL and will~     examine whether vitamin D or fish oil is associated with cognitive decline in 3000 older~     participants of VITAL.~   "
144963|NCT01669902|"~     This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab)~     in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use~     methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for~     6 months.~   "
144964|NCT01669889|"~     This multi-center, non-drug study will explore the relationship between exploratory~     biomarkers and functional dimensions in male adult individuals with Autistic Disorder or~     Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of~     assessments on study visit Day 1.~   "
144965|NCT01669876|"~     To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on~     blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's~     Disease (AD) in subjects with mild to moderate AD.~   "
144966|NCT01669863|"~     Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute~     respiratory failure~   "
144967|NCT01669850|"~     The purpose of this study is to determine whether handsewn anastomosis versus clipped~     technique is associated with more complications, fistula failures, surgical cost and surgical~     time.~   "
144968|NCT01669837|"~     Prospective, multicenter, observational registry to collect data of laparoscopic inguinal~     hernia repair using surgical tissue glue fixation. The objective is to determine the~     prevalence of chronic pain at 1 year.~   "
144969|NCT01669824|"~     In this non-interventional one year study, data about overall and particularly~     gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are~     collected by basic questionnaires, which are handed out by pharmacists to patients who~     acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter)~     Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study.~     After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get~     information about safety, usage and compliance under everyday's conditions, because in~     Germany low-dose aspirin is an OTC product with Rx indication.~   "
144970|NCT01669811|"~     This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to~     evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20~     mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux~     esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of~     presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA)~     classification~   "
144971|NCT01669798|"~     The main purpose of this study is to see if BIBF 1120 can increase the number of women with~     bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress~     for at least six months.~   "
144972|NCT01669785|"~     The study is intended to verify through clinical measurement that the NUPRO Sensodyne~     Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended~     relief up to 28 days.~   "
144973|NCT01669772|"~     DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These~     plants have been used in oriental traditional medicine for the treatment of gastrointestinal~     maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in~     functional dyspepsia patients and proved to have comparable safety and efficacy. However,~     its' exact effect on the gastrointestinal motility has not been completely elucidated. This~     study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.~   "
144974|NCT01669759|"~     The purpose of the present study was to investigate the correlation between the severity of~     fatigue, and the severity of qi deficiency and blood stasis.~   "
144975|NCT01669746|"~     Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female~     subjects with hair loss.~   "
144976|NCT01669733|"~     The purpose of this research is to study the effect music has on women undergoing surgical~     breast biopsy. Through the facilitation of live and/or recorded music listening, we will~     examine the perception of patient anxiety, the total amount of propofol required to obtain a~     BIS reading of 70, and recovery time in the PACU. We will also collect data and evaluate the~     effect of live and/or recorded music on patient satisfaction. It is hypothesized that:~        1. Patients in the live and recorded music groups will experience less anxiety than the~          non-music (standard care) group.~        2. Patients in the live and recorded music groups will experience a reduction in the amount~          of anesthesia needed to reach a state of moderate sedation compared to the non-music~          (standard care) group.~   "
144977|NCT01669720|"~     The main purpose of this study is to evaluate if aflibercept can reduce the chance that~     metastatic (spread of) colorectal cancer can grow back after finishing standard treatment.~     The study will also look at the side effects of aflibercept and the effect on quality of~     life.~   "
144978|NCT01669707|"~     The purpose of this study is to determine whether Endostar pumping into vein with~     Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly~     in the treatment of Non-Small Cell Lung Cancer (NSCLC).~   "
144979|NCT01669694|"~     This study is collecting serum and urine samples at various time points during pelvic floor~     physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and~     proteomics at various time points.~   "
144980|NCT01669681|"~     The severe asthma is a major source of expenses in term of public health, while it concerns~     no more than 5 % of the asthmatics. The expenses is direct (medicines, hospitalizations,~     care) but especially indirect (absenteeisms, etc.). The forward-looking follow-up of cohort~     of more than 500 severe asthmatic patients multicentrique in an already widely established~     cohort (COBRA, at present in Visit 9 (one every 6 months) is an once-in-a-lifetime~     opportunity, coupled with the data of the CPAM, to identify well the evolution in time of a~     real medical economic variable. The possibility of dynamic follow-up of the expenses compared~     to the medical data offers perspectives of evaluation cost-efficiency of the informed~     therapeutic procedures. It is possible to couple in a forward-looking and dynamic way the~     data of health stemming from a cohort with the economic data stemming from the CPAM. This~     variable included in a Cluster's algorithm has to allow to identify the interventions the~     more and the less cost effective. The main objective of this study is to realize a cost~     estimate of care of the severe asthma. The variation of the costs will be also studied. The~     recruited patients are patients already included in the cohort COBRA in the centers of~     Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.~   "
144981|NCT01669668|"~     This phase II trial studies how effectively radiofrequency ablation prevents recurrence of~     hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency~     ablation uses a high-frequency, electric current to kill tumor cells.~   "
144982|NCT01669655|"~     To characterize nutrient levels in breastfeeding infants and their mothers.~   "
144983|NCT01669642|"~     The purpose of the study is to find the dose of rapidly administered ketamine in 3 different~     pediatric age groups (2-5, 6-11 and 12-17) for abscess drainage and fracture reduction.~      Ketamine is the most common drug administered to children to facilitate painful procedures in~     the emergency setting because it achieves potent sedation, pain relief and amnesia with~     minimal adverse cardiopulmonary effects.(1-5) However, the 1-2 hour recovery period (1,6)~     associated with standard ketamine administration guidelines(7) strains work flow because it~     requires bedside one-on-one nurse monitoring in a treatment room, tying up these limited and~     valuable resources. Consequently, a combination of two other drugs, propofol + fentanyl~     (P/F), with recovery of 20-30 minutes, is rapidly gaining popularity for procedural sedation~     despite more frequent respiratory depression, apnea and hypotension caused by this~     technique.(2,4,8,9)~      The investigators believe recovery associated with our novel method for administering~     ketamine is significantly shorter than with the standard larger dose more slowly administered~     ketamine technique(7). Through the investigators clinical experience, the investigators have~     found rapid infusion of smaller than standard doses of ketamine safely achieves the drug's~     sedative effect, with the benefit of more rapid recovery due to the use of a smaller dose.~     However, this novel technique challenges published beliefs that time of recovery from~     ketamine sedation does not differ significantly with the dose administered, within the usual~     dose ranges, and that rapid infusion may cause respiratory depression, similar to that seen~     with other classes of sedative-analgesic drugs.(7,10) the investigators believe the slow~     infusion recommended by standard guidelines(7) requires a larger ketamine dose necessary to~     achieve effective sedation, and, consequently, prolongs recovery. It is the prolonged~     recovery that has prompted increased use of other less safe but briefer sedatives, such as~     propofol/fentanyl. By demonstrating patients recover rapidly with new ketamine technique,~     without increased adverse cardiopulmonary effects, the investigators will provide clinicians~     with an important new method for ketamine procedural sedation. The investigators believe~     clinicians will prefer more rapid recovery ketamine technique because it is safer and reduces~     pain and distress better than the propofol/fentanyl combination for sedation.~      The investigators complete proposal requires two steps. In Step One, this proposal, the~     investigators will determine the minimum effective dose of rapidly infused ketamine that~     achieves deep sedation for at least 5 minutes in 95% of children (ED95). Two groups of~     patients will be studied: one group is patients undergoing abscess incision and drainage and~     the other group is patients undergoing fracture reduction in our Emergency Department. The~     investigators believe that the ED95 is different for both the groups as the severity of pain~     is different. The investigators will compare the safety and recovery times to published~     standard ketamine techniques. In the following study, Step Two, the investigators will~     compare this novel technique, in a blinded randomized trial using the ED95 ketamine dose~     determined in Step One to the standard ketamine technique to determine if the novel technique~     results in significantly shorter recovery without an increase in the frequency of adverse~     effects. The study the investigators are proposing in this submission is Step One only.~   "
144984|NCT01669629|"~     This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a~     primary hypothesis of comparing the handling of each lens. Additional secondary markers are~     measured looking at subjective comfort and vision of the lenses.~   "
144985|NCT01669616|"~     The primary objective of the trial is to collect SCOUT DS, random capillary glucose and~     Hemoglobin A1c measurements from subject 18 years of age or older.~   "
144986|NCT01669603|"~     The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive~     host responses to rhinovirus infection.~   "
144987|NCT01669590|"~     The goal of the research project is to determine how aging and inactivity reduce the muscle~     anabolic effect of nutrients and lead to muscle and functional loss. The central hypothesis~     is that aging reduces mTORC1 signaling and the expression of skeletal muscle amino acid~     transporters in response to anabolic stimulation leading to reduced muscle adaptation to~     increased intracellular amino acid requirements. The investigators further hypothesize that~     inactivity exacerbates this effect with significant muscle and functional loss, and~     rehabilitation restores muscle signaling, metabolism and function to baseline values.~   "
144988|NCT01669577|"~     Prospective observational trial searching for independent predictors of mortality. Data was~     collected at trauma scene, ER, three and 24 hours of hospital stay.The patients will be~     followed for 30 days after hospital admission.~   "
144989|NCT01669564|"~     This study will evaluate a new tool, based on our currently implemented Functional~     Assessment Screening Tablets (FAST), and activate patients to partner with their physicians.~     Completion of this project, FAST-PRI, will provide important information on the effectiveness~     of using HIT patient feedback to inform and activate patients and promote health behavior~     change.~      Aim 1 Hypotheses: Patients who receive self-management support through HIT patient feedback~     (intervention) will be more likely than patients who do not receive such feedback (control)~     to:~        -  Initiate discussions with their provider regarding study-designated PRI;~        -  Have discussions with their providers, regardless of the initiator, regarding~          study-designated PRI; and~        -  Perceive these discussions of study-designated PRI to be useful. Approach: We will~          conduct a 12-month randomized controlled trial of HIT patient feedback, clustered at the~          physician level, in an academic group medical practice. Patients and providers will~          complete questionnaires regarding discussions of health behaviors and HRQoL at each~          clinical encounter.~      Aim 2 Hypotheses: HIT patient feedback will result in: 1) increased number of smoking quit~     attempts, 2) increased physical activity, and 3) improved mental HRQoL at six, and twelve~     months.~      Approach: Patient participants will complete questionnaires regarding smoking quit attempts,~     physical activity, and their mental HRQoL at baseline, six and twelve months.~      Aim 3 Hypotheses: For each study-designated PRI, patients who receive HIT patient feedback~     will: 1) receive more treatment recommendations (e.g., nurse educator, pharmacist, social~     worker referrals); 2) act on more treatment recommendations; and 3) exhibit improved~     self-efficacy regarding their ability to make positive lifestyle changes and improve their~     HRQoL; physicians whose patients receive HIT patient feedback will have higher self-efficacy~     regarding their ability to influence their patients to make positive lifestyle changes and~     improve HRQoL. These, in addition to discussions (Aim 1), will mediate the relationship~     between HIT patient feedback and improvements in study-designated PRI.~      Approach: We will survey patients and physicians and abstract referral data from the~     electronic medical record (EMR).~   "
144990|NCT01669551|"~     This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or~     transesophageal echo in patients with structural and valvular heart disease who are already~     scheduled to undergo a percutaneous intervention. Specifically those patients would be those~     scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac~     catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve~     replacement.~   "
144991|NCT01669538|"~     This is a randomized, double-blind, placebo-controlled study to test whether a medication~     called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces~     cognitive problems that smokers experience during a quit attempt.~   "
144992|NCT01669525|"~     The purpose of this study to determine if measurement of maternal serum biomarkers and~     evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy~     outcomes.~   "
145000|NCT01669421|"~     The current treatment of individuals with alpha-1 antitrypsin deficiency (AATD) who develop~     lung disease (COPD) is the administration of intravenous purified alpha-1 antitrypsin~     (augmentation therapy) at a fixed dose of 60 mg/kg per week. This dose aims at increasing the~     deficient AAT serum levels just above a predetermined safety threshold of 11 uM. However,~     normal levels of AAT are between 25-50 uM.~      AAT has shown not only to inhibit lung proteases such as neutrophil elastase, but also to~     modulate inflammation. Given that many subjects with AATD who receive augmentation therapy~     still have significant lung disease and inflammation, this study will evaluate whether~     doubling the dose to 120 mg/kg/week has an effect in decreasing lung inflammation.~      Only the dosing of 60 mg/kg /week has received FDA approval. FDA has granted an IND number to~     this study to test the higher dose of 120 mg/kg/week.~      The study will evaluate systemic (serum) and pulmonary (bronchoscopy samples)markers of~     inflammation in 3 phases: standard dose (4 weeks), double dose (4 weeks) and standard dose (4~     weeks).~   "
145001|NCT01669408|"~     Elevated body temperature was shown to be associated with worse outcome in acute stroke~     patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital~     cooling with cold infusions in stroke patients.~   "
144993|NCT01669512|"~     ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied~     in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated~     viruses which have been modified so that they cannot reproduce in humans. Genetic information~     has been added to make them express proteins of the malaria parasite so that they stimulate~     an immune response against malaria. This trial examines whether a compound called Matrix M™~     can be used in efforts to improve on how well the vaccines work at preventing malaria.~      Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines.~     In this trial, Matrix M™ will be combined with each of the vaccines. The objectives are to~     assess the safety of the vaccines when combined with Matrix M™, and to determine what effect~     Matrix M™ has on the immune responses to the vaccines.~      We will assess the safety of the vaccines (ChAd63 METRAP combined with Matrix M™; and MVA~     METRAP combined with Matrix M™) by administering them to healthy volunteers and monitoring~     them for 6 months in total. Eight volunteers will receive the vaccines with the low dose of~     Matrix M™, eight will receive the vaccines with the standard dose of Matrix M™, and six~     volunteers will receive the vaccines alone as a comparison group. We will also look at what~     effect Matrix M™ has on the immune responses to the vaccines, as measured from blood tests.~     Volunteers will have study visits to the Clinical Centre for Vaccinology and Tropical~     Medicine on the Churchill Hospital site, Oxford, where they will have vaccinations, have~     blood taken to monitor safety and measure immune responses to vaccination, and be monitored~     for symptoms/side effects from vaccination.~   "
144994|NCT01669499|"~     Cancer patients with pain due to bone metastases are often treated with external irradiation~     in order to reduce pain. However, patients may experience a temporary increase of pain~     shortly after irradiation, a so-called pain flare. This study investigates whether a short~     course of a drug called dexamethasone may prevent the occurrence of a pain flare. Patients,~     who are irradiated for painful bone metastases are randomized into three groups. Group 1~     receives placebo during four days, group 2 receives dexamethasone on the day of the~     irradiation and placebo during three days, and group 3 receives dexamethasone during four~     days. All patients complete a questionnaire on pain, side-effects of treatment and quality of~     life during 14 days and after four weeks. This study will define whether dexamethasone~     decreases the occurrence of a pain flare after irradiation for painful bone metastases, and,~     if so, whether four days of treatment with dexamethasone is better dan one day of treatment.~   "
144995|NCT01669486|"~     The purpose of this research is to find the best system for assessing the pain of critically~     ill patient in Intensive Care Unit (ICU).~      At first the investigators assess the sedation of the patient with the scale~     sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the~     patient is too sedated or delirious the investigators consider him unable to use the Visual~     Analogic Scale (VAS).~      The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and~     Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in~     three different moments: before, during and after the nurses' care.~      The investigators compare the scales between them. Then, every time the investigators value~     the score of these scales with the self-report of patients with the VAS scale (when it is~     possible) and finally with the physiological parameters (blood pressure, heart rate and~     respiratory rate).~      In the end, the investigators compare two different classes of patient: the surgical and~     medical one. The investigators search for some differences in the perception of the pain~     between these two classes.~   "
144996|NCT01669473|"~     This study seeks to evaluate a low-literacy strategy in a primary health care setting for~     promoting safe and effective prescription medication use among English and Spanish-speaking~     patients with diabetes.~      The investigators hypothesize that in comparison with patients receiving standard care, the~     patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better~     understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies~     in their medication lists; 3) take their medication regimen more efficiently; 4) have greater~     adherence to their medication regimen.~   "
144997|NCT01669460|"~     The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce~     fatigue in prostate cancer patients receiving LHRH agonist therapy.~   "
144998|NCT01669447|"~     Significant difference in the parameter settings of early optical coherence tomography (OCT~     spectal domain) in patients with subfoveal neovascular membrane realacionada age after~     treatment with a single intravitreal injection of Lucentis.~   "
144999|NCT01669434|"~     Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and~     including the morning of a non-cardiac, non-vascular surgery will experience more~     intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.~      Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and~     including the morning of a non-cardiac, non-vascular surgery will experience better~     postoperative control of hypertension than those who transiently hold their chronic ACEI~     preoperatively.~      Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and~     including the morning of a non-cardiac, non-vascular surgery will experience less acute renal~     failure than those who transiently hold their chronic ACEI preoperatively.~      Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic~     blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and~     including the morning of a non-cardiac, non-vascular surgery will experience more~     intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.~      Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who~     continue their chronic ACEI therapy up to and including the morning of a non-cardiac,~     non-vascular surgery will experience more intraoperative hypotension than those who~     transiently hold their chronic ACEI preoperatively.~   "
145002|NCT01669395|"~     The purpose of this study is to investigate the effect of an early, coordinated~     rehabilitation intervention for patients with severe heart failure in NYHA class III and IV~     with a ejection fraction of <40% of normal cardiac function measured on frequency of~     readmissions, physical ability and participation in activities of daily living and quality of~     life.~   "
145365|NCT01664663|"~     The purpose of this study is to examine the valu of individually dose escalated radiotherapy~     compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy~     for patients with locally advanced non small cell lung cancer (stage III) with good~     performance status.~   "
145003|NCT01669382|"~     Background:~      Vascular closure devices (VCD) were developed to reduce access site bleedings, to improve~     patients´ comfort, and to accelerate ambulation after percutaneous coronary interventions~     (PCI). Despite higher complications rates in earlier studies, current data suggest similar~     complication rates or better outcomes after the use of VCD as compared to manual compression.~     ExoSeal (Cordis, Warren, NJ, USA) is a new, extravascular polyglycol acid (PGA) plug which~     occludes the puncture channel. Whether the use of this extravascular closure device is as~     effective as the more widely used plug/anchor mediated devices, has not been evaluated so~     far.~      We performed a randomized, multicentre, single-blinded trial to compare the efficacy of the~     extravascular closure device ExoSeal in comparison to the collagen-based plug/anchor mediated~     AngioSeal system.~      Methods:~      304 patients receiving diagnostic angiography and/or PCI will be included in three centers.~     Exclusion criteria are contraindications for any VCD including 1. severe calcification of the~     access vessel, 2. severe peripheral artery disease, 3. puncture in the origin of the profound~     femoral artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the femoral or iliac~     artery, 5. marked obesity or cachexia (BMI >40 or <20) and 6. patients on continuous~     medication with oral anticoagulants.~      After the procedure, angiography of the accessed femoral artery is performed to rule out~     major risk factors for retroperitoneal hemorrhage, relevant peripheral stenoses of the common~     or the superficial femoral artery, or a location of the puncture site in the bifurcation of~     the profundal femoral artery.~      We hypothesise, that the use of an extravascular closure device is not inferior to an~     anchor/plug mediated device regarding the occurrence of the following complications:~     bleeding, need for vascular surgery and device failure (primary endpoints). Secondary~     endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm~     within 24 hours after insertion of the device. Power was 80%, alpha 0.05. Bleeding will be~     defined according to the TIMI criteria. The study is actively enrolling patients, last~     inclusion will take place in September 2012.~      Results and Conclusions:~      Outcome data including the primary endpoint (bleeding, need for vascular surgery and device~     failure) will be presented for the first time.~   "
145004|NCT01669369|"~     The purpose of this study is to determine whether Lithium Carbonate combined with~     neo-adjuvant chemotherapy improve the prognosis of osteosarcoma~   "
145005|NCT01669356|"~     Malnutrition is common in esophagus cancer patients, especially after surgery therapy.~     Whether parenteral supplement with enteral nutrtion is benificial for patients after~     esophagectomy is controversial, when compared with enteral nutrition alone. In this study,~     the investigators are to examine the effect of enteral nutrition supplemented with parenteral~     nutrtion on nutrition status after esophagectomy.~   "
145006|NCT01669343|"~     The purpose of this study is to examine how key patient factors, including body size affect~     how well letrozole suppresses circulating estrogen levels.~      This study has two components: (1) Part A - an observational phase to evaluate the impact of~     vitamin D and obesity on estrogen suppression in post-menopausal women already receiving~     letrozole treatment, and (2) Part B - an interventional phase for women with body mass index~     (BM) > 25 kg/m2.~      If BMI or other patient factors reduce the effectiveness of letrozole, modifications to~     treatment recommendations and studies to test higher dosing of letrozole may be needed to~     maximize the benefit of this treatment and minimize the risk of the breast cancer coming~     back.~   "
145007|NCT01669330|"~     The most widely used operative technique for gastroesophageal reflux is total fundoplication~     where the gastric fundus is sutured around the distal esophagus like a wrap. This operation~     effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related~     to over-competence of the gastroesophageal junction. 40% of the operated patients experience~     increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique~     where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of~     the front wall of the esophagus is covered with fundus. An anterior fundoplication is un~     attempt to create a more physiologic reflux control and less functional problems~     postoperatively. The aim with this study is to compare the results postoperatively, both~     short time and long time results.~   "
145008|NCT01669317|"~     This study is designed to demonstrate that cherry juice is effective in treating insomnia,~     and to show that it works by inhibiting an enzyme that will be measured in the blood.~   "
145009|NCT01669304|"~     Vestibular migraine (VM) and chronic subjective dizziness (CSD) commonly cause vertigo,~     unsteadiness and dizziness. Clinical investigators are studying these illnesses to understand~     them better. VM and CSD occur together in about 1/3 of patients. That makes it hard to~     diagnose them accurately and decide what treatments to use. As a result, doctors and patients~     may be confused about these diagnoses. The goal of this study was use two different~     medications to tease apart the symptoms of VM and CSD.~      Patients who have VM and CSD together were given either verapamil or sertraline for 12 weeks.~     These medications are used to treat VM and CSD, though they are not approved for this~     purpose. Verapamil is believed to have stronger effects on symptoms of VM. Sertraline is~     believed to have stronger effects on symptoms of CSD. By comparing the responses of patients~     to these two medications, the researchers hoped to learn more about the key features of VM~     and CSD.~   "
145010|NCT01669291|"~     The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long~     protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for~     assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.~   "
145011|NCT01669278|"~     The processing of standard flexible nasopharyngoscopes is a time-consuming and costly~     process. The goal of this study is to determine the efficiency and cost-effectiveness of~     sheathed flexible endoscope in an office setting.~   "
145012|NCT01669265|"~     This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early~     breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by~     one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.~      The aim of the present study is to assess the intraoperative positive SLN total tumor load~     (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN~     metastasis in patients with clinically node-negative early-stage breast cancer.~   "
145013|NCT01669252|"~     This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory~     pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with~     operable Stage III HER2 non-overexpressing breast cancer.~   "
145014|NCT01669239|"~     This is a prospective, multicenter, single-arm, phase II study to evaluate the safety of~     neoadjuvant liposomal doxorubicin plus paclitaxel, trastuzumab, and pertuzumab in patients~     with HER2-positive breast cancer~   "
145015|NCT01669226|"~     The purpose of this study is to evaluate the role of an additional intraperitoneal~     chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.~   "
145016|NCT01669213|"~     The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3~     receptor antagonists on prevention of hypotension after spinal anesthesia~   "
145020|NCT01669161|"~     Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll.~     Patients will be randomized to one of two groups - a group implanted with a device that~     allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no~     implant). Patients have two baseline evaluations, one evaluation after implant but before~     initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS,~     followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of~     treatment. The intent is to assess safety and provide preliminary effectiveness information~     for VNS for upper limb functional improvement after stroke. Implanted patients may receive~     longer-term treatment and follow-up after the acute study.~   "
145021|NCT01669148|"~     The primary hypothesis to be tested is:~      The detection of breast cancer will be increased with tomosynthesis (3D) imaging~   "
145022|NCT01669135|"~     The cerebral oxygen saturation is assessed by means of near-infrared spectometry in~     parturients undergoing cesarean delivery under spinal anesthesia. The investigators~     hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.~   "
145023|NCT01669122|"~     This is a randomized, single center, open label, single dose, four way crossover study in~     fasted healthy male subjects to compare the pharmacokinetics of nicotine following~     administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg~     nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12~     hours post dose in each treatment session and plasma samples analyzed for nicotine levels.~   "
145024|NCT01669109|"~     Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques,~     and meditation. It is used in India since centuries to improve well-being and cope with~     diseases and is gaining more and more interest in Europe and the US. While studies have~     demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients~     with colorectal cancer are available yet. The purpose of this study is to investigate the~     effect of Hatha Yoga in patients with colorectal cancer.~   "
145025|NCT01669096|"~     The purpose of this study is to assess the safety and immunogenicity of two doses of the TB~     vaccine administered according to a 0, 1 month schedule. In, addition, blood samples~     collected at different time points after vaccination will be analysed to see when exactly~     genes are activated by the vaccine using an assay called mRNA expression profiling. The~     different methods for mRNA expression profiling using whole blood samples versus Peripheral~     Blood Mononuclear cell(s) (PBMCs), will also be compared.~   "
145026|NCT01669083|"~     GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst~     implantation in women undergoing IVF treatment. This study will be the first dosing~     experience with this compound in women. It is important to characterize the pharmacokinetics~     of GSK557296 in women to determine the most appropriate doses and dosing regimens for future~     clinical studies. Understanding the pharmacokinetics of GSK557296 in women will also enable~     more accurate characterization of any exposure-response relationship in future studies.~      Two previous studies with GSK557296 were conducted in men with oral doses ranging from 10~     milligram (mg) to 200 mg. GSK557296 is being studied in women for the indication of enhanced~     embryo and or blastocyst implantation in women undergoing IVF treatment. This is a bridging~     study to characterize the pharmacokinetics of GSK557296 in women to determine the most~     appropriate doses and dosing regimens for future clinical studies.~      This is a non-randomized, open label, adaptive design study in healthy female volunteers. A~     maximum total of 48 subjects, will participate in different cohorts. Subjects in Cohort 1~     will receive 10 mg single dose followed by repeat dose. A one week break will occur to allow~     for analysis of the PK data, prior to starting the second Cohort. Subjects in Cohort 2 will~     receive 150 mg single dose followed by repeat dose. Cohort 3 and Cohort 4 were adaptive based~     on the requirement of additional doses to be studies after PK data will be analyzed from each~     of the first 2 cohorts.~   "
145027|NCT01669070|"~     The purpose of this study is to demonstrate dose proportionality of the FF (50 microgram~     (mcg), 100 mcg or 200 mcg), when administered as a single and repeat dose from the NDPI~     containing FF formulated with lactose. In addition, the aim of this study is to determine the~     absolute bioavailability of the FF single strip product using the high strength product~     administered as a single dose with multiple inhalations and using 250 mcg intravenous (IV)~     FF.~      This is a, part-randomized, open-label, 4 way crossover study (4 periods) in healthy adult~     subjects. During each period, subjects will receive FF in the morning and serial~     pharmacokinetic (PK) sampling (for up to 10 days for the inhaled treatment and up to 3 days~     for the IV treatment) and safety assessments will be performed. Each period will be separated~     by a washout period of at least 7 days and a follow-up telephone call will occur 7 -14 days~     after the last dose of study drug. The total duration of the study will be approximately~     13-14 weeks for each subject.~   "
145028|NCT01669057|"~     The objective of this study is to investigate the effect of parental peri-natal environmental~     risk factors and genetic factors on the development of Congenital Heart Disease (CHD). Our~     hypothesis is that the distributions of some environmental and genetic risk factors~     significantly differ between neonates with and without CHD.~   "
145029|NCT01669044|"~     The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic~     qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be~     easily roused, these advances shows dexmedetomidine may be a effective and safe sedative~     agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics~     (such as bradycardia, hypotension), the investigators want to further research the effects of~     dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance~     Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely~     effects like bradycardia and hypotension, so the investigators want to compare the effect of~     dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to~     further research the mechanism of haemodynamics of dexmedetomidine.~   "
145030|NCT01669031|"~     Unreliability and visual field variability is a known problem with automated perimetry in~     both developing and developed country settings. This study will look at the effects of a~     computer program that allows new patients to practice the visual field exam before taking the~     actual exam. Our hypothesis is that the intervention group will have less variability as~     measured by mean deviation between exams and greater reliability as measured by the standard~     unreliability indexes of false positive rate, false negative rate, and fixation losses.~   "
145031|NCT01669018|"~     Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of~     nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a~     relevant technique in patients with severe cardiac comorbidity. The technique is a safer~     alternative compared to general or spinal anesthesia in these fragile patients.~      The most recognized technique with ultrasound guidance (Karmakars technique) is technically~     demanding and based on injection of local anesthetic relatively close to the exit of the~     spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal~     prompting a risk of low blood pressure. This may be fatal in high risk patients.~      The investigators have developed a simple technique based on injection away from the spinal~     canal. The investigators expect minimal risk of spread of local anesthetic to the spinal~     canal with this technique.~      This randomized, double blinded trial compares the new technique to the established technique~     of ultrasound guided blockade of the lumbar plexus.~      The hypothesis is that the new technique has a higher success rate with reduced effect on~     blood pressure for ultrasound guided lumbar plexus block compared to the established~     technique.~   "
145032|NCT01669005|"~     Objectives: Invasive infections are the leading cause of morbidity and mortality in patients~     treated for hematological malignancies. Blood cultures are often negative in neutropenic~     patients because of low-burden of organisms, previous antibiotic therapy or non-infectious~     reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.~      Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before~     febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for~     multiplex PCR at admission and 3x/week thereafter until discharge or recovery from~     neutropenia~   "
145033|NCT01668992|"~     The study will evaluate the impact of a family-based intervention on the well-being of~     Burmese migrant and displaced children and families living in Tak province, Thailand. The~     methodology used in the impact evaluation study is a randomized waitlist controlled trial.~      The study hypothesizes that participation in a family-based intervention will lead to~     improved parenting practices and child and family outcomes, as follows.~      Primary hypotheses:~        1. Parents/caregivers participating in the family-based intervention will report increased~          knowledge and use of positive parenting skills compared to control;~        2. Parents/caregivers participating in the family-based intervention will report less use~          of physical punishment and other harsh forms of discipline compared to control;~        3. Parents/caregivers and children participating in the family-based intervention will~          report higher levels of family functioning and cohesion compared to control.~      Secondary hypotheses:~        1. Parents/caregivers and children participating in the family-based intervention will~          report lower levels of externalizing and internalizing child behaviors compared to~          control;~        2. Parents/caregivers and children participating in the family-based intervention will~          report higher levels of child resilience and psychosocial well-being compared to~          control;~        3. Parents/caregivers participating in the family-based intervention will report lower~          levels of alcohol use compared to control.~   "
145034|NCT01668979|"~     The study is aimed to assess a new system for the automatic detection, quantification and~     treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The~     system is comprized of a treadmill and a virtual reality simulation which provides a~     motor-cognitive challenge to provoke NF. The challenges provided by the system are~     individualized and using machine learning algorithms will enable the identification and~     detection of NF under different conditions and allow for the most suitable treatment.~   "
145035|NCT01668966|"~     This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01649804)~     will evaluate the safety and efficacy of tocilizumab in participants with early moderate to~     severe rheumatoid arthritis who have completed the 104-week WA19926 (NCT01649804) core study.~     Eligible participants will be those who are expected to benefit from the study medicine based~     on the investigator's discretion.~   "
145036|NCT01668953|"~     Tennis elbow is the most common cause of lateral elbow pain, generally caused by either~     work or sports related repetitive strain. In this condition, a tendon along the outside of~     the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.~      Many treatments have been attempted, including physiotherapy and steroids, with little~     success. One treatment which has been very effective is the injection of the patients own~     blood (taken from their other non-affected arm) into their abnormal tendon. The blood~     recruits the patients own healing factors and heals the damaged tendon. As platelets are~     thought to be largely responsible, injection of concentrated platelets, extracted from the~     patient's blood (platelet rich plasma) is a newer, but expensive, technique.~      At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a~     ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing~     (tendon fenestration) is the better treatment.~      The objective of this trial is to compare platelet rich plasma, whole blood, dry needle~     tendon fenestration, and sham injection (with physical therapy) to identify the best and most~     cost-effective therapy for this debilitating condition.~   "
145037|NCT01668940|"~     The primary objective of this study is to assess the effectiveness of Lillipops in the~     improvement of morning sickness symptoms. Secondary objectives are to assess if there are any~     changes to concurrent symptoms that may intensify NVP, such as metallic taste or~     gastrointestinal issues (e.g. heartburn, acid reflux, indigestion and gas), as well as~     preference for freezie flavours.~   "
145038|NCT01668927|"~     The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone,~     amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these~     three antimicrobials was rare. It is necessary to assess the efficacy and safety of these~     four bismuth-containing quadruple regimens with above antibiotics as empirical rescue~     therapies for H. pylori eradication.~   "
145081|NCT01668368|"~     Patients with acute respiratory failure exhibiting decreased respiratory system compliance~     with hypoxemia or carbon dioxide retention are often difficult to ventilate with current~     guidelines that limit applied plateau pressure Yet, these guidelines do not take into~     consideration chest wall mechanics. The investigators sought to determine whether partition~     of the respiratory system into its components by measuring esophageal pressure and thus~     assessment of pleural pressure, would help in patients with acute respiratory failure to~     identify the factors contributing to low respiratory system compliance.~   "
145039|NCT01668914|"~     In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is~     another important lymphatic channel of the breast. The status of IMLNs also provides~     important prognostic information for breast cancer patients. The technical evolvements of~     sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for~     assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was~     performed in the patients with clinically negative axillary nodes. However, previous~     published studies concerning patients with breast cancer who all underwent a radical~     mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary~     metastases. For this reason, IM-SLNB is even more important for clinically axillary~     node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early~     breast cancer patients with clinically positive axillary nodes.~   "
145040|NCT01668901|"~     In this study, the investigators examine whether aspirin or warfarin is useful for atrial~     fibrillation patients with chronic kidney disease.~   "
145041|NCT01668888|"~     Inflammation has been known to be a pivotal pathogenic mechanism of obesity-related disorders~     such as type 2 diabetes, metabolic syndrome and atherosclerosis. Adipose tissue functions as~     a major endocrine organ by adipokine mediated modulation of a number of signaling cascades in~     target tissues, that has pro-inflammatory or anti-inflammatory activities. Progranulin and~     CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to clarify~     the clinical meaning of these two adipokines in the subjects with or without metabolic~     syndrome~   "
145042|NCT01668875|"~     The purpose of this study is to explore acute hemodynamic and ventilatory responses to~     head-down 30 degree postural drainage position in patients with blunt chest and/or abdominal~     injury in the traumatic intensive care unit.~   "
145043|NCT01668862|"~     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of~     human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study~     is being conducted in 2 centers in India. The primary end points are Visual Analog Score~     (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is~     improvement in ultrasonography form randomization to End of study.~   "
145044|NCT01668849|"~     This study will evaluate the ability of grape exosomes, given to the subject as grape powder,~     as an important anti-inflammatory agent to reduce the incidence of oral mucositis during~     radiation and chemotherapy treatment for head and neck tumors.~   "
145045|NCT01668836|"~     Women have a natural protection that gives them greater longevity. One hypothesis most~     commonly used is the estrogen protection in the premenopausal period. However many studies of~     various forms of hormone replacement therapy proved ineffective in promoting additional~     protection for women. Thus, it is discussed other ways of protection associated with~     longevity in women. Of these, the sirtuin system was found in several animal studies to be~     associated with longevity. This system also showed, through the involvement of several~     metabolic pathways, an important protection against the process of atherosclerosis. But the~     activity of this system in humans is unknown and if it is more active in women than in men.~     The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55~     to 65 years, and their influence on the main metabolic pathways related to longevity and the~     process of atherosclerosis. The research protocol includes analysis of the influence of~     sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of~     inflammation and homeostasis, before and after the interventions with caloric restriction or~     resveratrol administration. It is expected of this study mechanistic conclusion for longevity~     and possible clinical applications in the mechanism of atherosclerosis prevention.~   "
145046|NCT01668823|"~     This phase I trial is studying the side effects and best dose of photodynamic therapy using~     HPPH in treating patients with lung cancer. Photodynamic therapy uses a drug, such as HPPH,~     that becomes active when it is exposed to a certain kind of light. When the drug is active,~     cancer cells are killed.~   "
145047|NCT01668810|"~     The investigators aimed to examine the psychotropic prescription pattern in China.~   "
145048|NCT01668797|"~     The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo~     as maintenance treatment in adults with schizophrenia.~   "
145049|NCT01668784|"~     The purpose of the study is to compare the clinical benefit, as measured by duration of~     overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic~     clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy~   "
145050|NCT01668771|"~     Background:~      - Self-affirmation is the process of reflecting on values that a person considers important.~     This process may encourage people to be more open to information about health risks. It may~     also encourage them to change their behaviors or lifestyle to decrease these health risks.~     Researchers want to look at the effect of self-affirmation on people s responses to new~     health risk information. Because recent studies have linked alcohol consumption to increased~     risk of breast cancer, the study will focus on alcohol s link to breast cancer.~      Objectives:~      - To study how self-affirmation can change opinions following a message about a health risk.~      Eligibility:~      - Women at least 18 years of age who drink at least two alcoholic beverages per week and/or~     at least three alcoholic beverages per sitting.~      Design:~        -  Participants will be recruited through an online panel. The study will be conducted~          entirely online.~        -  Participants will respond to two short studies. The first will ask about life events and~          how they make people feel. The second will look at how people respond to information~          about alcohol and breast cancer.~        -  For the first study, participants will write a paragraph or two about an important event~          in their lives. They will answer questions about how that event made them feel. They~          will also write a paragraph about an important personal value.~        -  For the second study, participants will read information about alcohol and breast cancer~          risk. They will then answer questions about this information. They will also answer~          questions about their beliefs about alcohol and breast cancer.~        -  Participants will receive financial compensation for being in this study.~   "
145093|NCT01668212|"~     Perifollicular Doppler could reflect the quality of the follicle's vascularization and,~     consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the~     analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.~      The goal of this study is to evaluate if there is a link, in natural cycle In Vitro~     Fertilization, between the quality of the vascularization and the one of the oocyte, the~     embryo and the pregnancy.~   "
145051|NCT01668758|"~     Background:~      - The amount of blood flowing in brain areas goes up when those areas are being used for~     activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a~     common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also~     be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI.~     Researchers want to compare fMRI and NIRS to see whether they give similar results. These~     studies will be used to look at people who have had a traumatic brain injury.~      Objectives:~      - To test how well NIRS measure changes in blood flow in the brain after a traumatic brain~     injury.~      Eligibility:~        -  Individuals between 18 and 60 years of age who have had a traumatic brain injury.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Researchers may~          ask to see brain images during from previous MRI scans.~        -  Participants will have a NIRS scan of the brain. They will be asked to do certain tasks~          while inside the scanner. These tasks will involve responding to images that appear on a~          screen.~        -  Treatment will not be provided as part of this study.~   "
145052|NCT01668745|"~     Background: All observational studies and a few randomised controlled trials (RCT) suggest~     that early measles vaccine (MV), in particular an early two-dose strategy, has a much better~     effect on overall mortality than later MV. These results suggest that MV has a non-measles~     related beneficial effect on child survival.~      Objective: To evaluate in a multi-center RCT the effect on child survival and other health~     indicators of a two-dose measles vaccination schedule by providing an additional dose of~     Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard~     measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and~     Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site~     separately and a 32% reduction overall. Based on the results from the RCT, the investigators~     will assess the cost-effectiveness of the intervention.~      Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance~     System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and~     campaign vaccinations will be collected regularly through home visits and health centre~     registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3),~     the children will be eligible for enrollment in the trial if they are not severely ill.~     Eligible children will be invited to take part in the trial. Provided parental informed~     consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9~     months. Cost estimates will be based on consumption of services and average cost per unit.~     The incremental cost effectiveness ratio will be calculated.~      Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each~     site the investigators intend to enroll at least 4050 children in Burkina Faso. The children~     will be followed for survival and hospitalisations to 3 years of age or to the end of the~     study after three years. The investigators will analyse the effects by site and combined; by~     sex and season; possible interactions with other interventions like campaigns with drugs,~     vaccines or micronutrients will be explored.~      Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of~     maternal antibody levels on subsequent antibody responses to MV. The children will be~     followed to 24 months of age and samples collected at 4, 9 and 24 months of age.~   "
145053|NCT01668732|"~     Heroin addiction has emerged as a serious problem with tremendous impacts on the addicts and~     the society. Since the introduction of opioids substitutive treatment in 2006, more than~     30,000 heroin addicts had received treatment, and nearly 12,000 continued on treatment~     currently. However, an unknown proportion of patients hidden in community remained~     un-treatment. To motivate the community heroin addicts is thus a challenging task.~      It is suggested that decision making deficit is core feature which determine outcomes and~     treatment motivations in patients with addiction disorders. Recently, the state-of-the-art~     development of epigenetics uncover that environmental modification, via altering level of DNA~     methylation and gene expression will influence on neurocognitive functioning.~      Via respondent-driven sampling, this study aims to recruit a representative sample targeting~     at the hard-to-reach community heroin addicts. The goal of this study is to identify the~     clinical feature as well as decision making-related neurocognitive deficit in these patients.~     Moreover, the investigators will explore the interplay of clinical features, DNA methylation~     and gene expressions on opioids receptor genes. The findings will help to clarify the~     clinical characteristics of community heroin addicts, to uncover the links between DNA~     methylation and clinical features of heroin addiction and to develop modifiable treatment~     targets in the future.~   "
145054|NCT01668719|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     elotuzumab and to see how well it works when given together with lenalidomide, bortezomib,~     and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely~     to recur (come back), or spread (high-risk). Lenalidomide and bortezomib may stop the growth~     of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as lenalidomide and dexamethasone, also work in different ways to kill~     cancer cells, by stopping them from dividing, or by stopping them from spreading. Giving~     elotuzumab together with lenalidomide, bortezomib, and dexamethasone may be a better way to~     block cancer growth.~   "
145055|NCT01668706|"~     Opioid abuse is a complex problem, which not only impacts on addicts' physical and~     psychological health individually, but also threats the society. Recently, spread of HIV via~     sexual behavior and needle sharing among injecting drug users (IDUs) also becomes a serious~     public health problem all over the world. In Taiwan, since the first HIV-infected IDU~     identified in 1987, the incident cases have mounted to 2,461 in 2005. To prevent the~     epidemics of HIV among IDUs, the Center for Disease Control (CDC) thus collaborated with~     Department of Justice and implemented harm reduction programs in 2005. It is the milestone~     that opioid addiction is officially treated as a health rather than a legal issue in Taiwan.~     Among the harm reduction programs of needle and syringe exchange for IDUs as well as~     substitution treatment for opioid dependence, methadone maintenance treatment (MMT) is one of~     the most important parts. Till 2008, there were over 13,000 heroin addicts participated in~     more than 80 MMT programs.~      Although the clinical evidences have proven the superior effectiveness of maintenance therapy~     in ameliorating illicit substances abuse, decreasing criminality and improving quality of~     life, there are common problems of sleep disturbance and neurocognitive impairments among the~     subjects receiving opioid medications. The concerns of the adverse effects might thus~     frustrate the subjects' motivation and compliance to maintain treatments. However, sleep~     disturbance and neurocognitive impairments related to opioid medications are often neglected~     in the clinical practices and there are scanty researches focusing on these crucial issues in~     the existing literature.~      In this prospective study, four groups of subjects including methadone maintenance treatment,~     buprenorphine/naloxone, medication-free opioid ex-addicts and healthy volunteers will be~     enrolled. Via the comprehensive assessments including clinical interview, neurocognitive~     examinations, electrocardiogram-based sleep breathing detector and pharmacogenomical~     evaluation, we will not only have the opportunities to have more insights on the impacts of~     opioid medications on sleep and neurocognitive performances, but also develop more adequate~     strategies to improve motivation and outcome in treating the opioid addicts.~   "
145056|NCT01668693|"~     The purpose of this study is to demonstrate the clinical efficiency of the Endometrial~     Receptivity Array (ERA) diagnostic tool in patients with repetitive implantation failure~     (RIF), leading to the new concept of the personalized window of implantation (pWOI) as~     diagnostic and treatment of patients with RIF of endometrial origin.~   "
145094|NCT01668199|"~     A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.~   "
145057|NCT01668680|"~     Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy~     which may be toxic +/- exhausting are candidates for an effective and more convenient~     maintenance treatment.~      Objectives:~        1. To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM)~          regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.~        2. To discover predictive factors for response to this LDM regimen.~      Hypothesis:~        1. The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM~          chemotherapy.~        2. Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation~          of certain enzymes in the tumor may discover predictive factors of response to LDM~          chemotherapy in metastatic CRC patients.~   "
145058|NCT01668667|"~     Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently~     approved in the United States for the treatment of adults with moderate-to-severe primary~     Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy, tolerability,~     and safety of GEn at lower doses (450 and 300 mg/day) as well as the already approved dose of~     600 mg/day versus placebo for the treatment of subjects with moderate to severe primary RLS.~     This study is being conducted as a post-marketing commitment (PMC) as a condition of the~     approval of HORIZANT tablets (NDA 022399).~   "
145059|NCT01668654|"~     The purpose of this study is to evaluate the long-term safety and tolerability of~     retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset~     seizures (12 to < 18 years old) or Lennox-Gastaut Syndrome (12 to <30 years old) who have~     participated in a previous (parent) study.~   "
145060|NCT01668641|"~     -  Ninety patients suffering from active rheumatoid arthritis despite continued treatment~          with methotrexate will be evaluated for improvement of disease activity when taking~          GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks.~        -  During the course of the study, patients will also be examined for any side effects that~          may occur, and the amount of GLPG0634 present in the blood as well as the effects of~          GLPG0634 on disease- and mechanism of action-related parameters in the blood will be~          determined.~   "
145061|NCT01668628|"~     The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal~     dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and~     depression over time.~   "
145062|NCT01668615|"~     The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are~     effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).~   "
145063|NCT01668602|"~     Stroke is the number one cause of disability. Difficulty with walking affects most stroke~     survivors. The focus of this project is to understand the effects of different methods (such~     as treadmill walking and electrical stimulation) that can be used to improve walking in~     people with stroke. In this study, patients with stroke and healthy people who have not had a~     stroke will be tested. Study participants will take part in walking evaluation and training~     sessions. Walking patterns will be measured using automatic cameras and standard clinical~     tests. Also, magnetic brain stimulation maybe used to measure brain-muscle connections, and~     muscle stimulation may be used to measure spinal-cord circuits during the training. This~     research will provide information on how different factors that affect walking in stroke~     change with walking training. The investigators hypothesize that improvements in brain~     excitability of the muscles targeted by walking training will occur after training, and these~     changes in brain excitability will be related to improvements in walking patterns. By~     improving our understanding of walking rehabilitation, this study can help improve walking~     function and disability in people with stroke.~   "
145064|NCT01668589|"~     The main objective of this observational study was to describe medication-taking behavior of~     patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.~   "
145065|NCT01668576|"~     The major limitation to long term survival in lung transplant recipients is the development~     of graft failure over time, termed bronchiolitis obliterans. The conventional therapies used~     to prevent rejection are not effective in preventing bronchiolitis obliterans. Therefore, new~     therapies are needed to address this problem. A growing body of research has focused on a~     unique population of bone marrow cells termed Mesenchymal Stem Cells (MSCs) to improve a~     range of medical conditions including heart failure, autoimmune disease, and inflammatory~     bowel disease. MSCs can prevent animal models of bronchiolitis obliterans. Because of this~     information, it is plausible that MSCs could help patients as a potential treatment in lung~     transplantation.~      This proposal will test the immunologic properties of MSCs generated from such individuals to~     answer the question of whether generation of whether it would be feasible to use such cells~     in the future to prevent entities such as bronchiolitis obliterans.~      The Investigator will approach patients who are being considered for a lung transplant~     because of end stage lung disease. Enrolled patients will undergo a bone marrow aspiration~     where a small amount of fluid is removed from their pelvic bone. Cells obtained in this~     procedure will be expanded in the Emory/Georgia Tech Cell Lab. MSCs will be expanded in this~     lab using cell culture conditions which are standardly used for MSCs.~   "
145066|NCT01668563|"~     The purpose of this study is to compare the clinical outcome of surgical clipping and~     endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT~     Study.~   "
145067|NCT01668550|"~     The purpose of this study is to determine the maximum tolerated dose of the oral Src/Abl~     inhibitor AZD0424, and to find tolerable and effective AZD0424 combination regimens for the~     treatment of advanced solid tumours~   "
145068|NCT01668537|"~     A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and~     safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox~     vaccine in vaccinia-naïve healthy subjects~   "
145069|NCT01668524|"~     This single-site, dose-escalation study will evaluate safety and tolerability of increasing~     concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular~     Hypertension~   "
145070|NCT01668511|"~     To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with~     osteoarthritis of the knee.~   "
145452|NCT01663311|"~     Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways~     contributing to the perception of phantom sounds, and the regulatory neural network~     responsible for the generation of the individual amount of suffering caused by chronic~     tinnitus.~   "
145071|NCT01668498|"~     80 - 90 % of the patients treated with anti-EGFR antibodies (panitumumab or cetuximab)~     experience skin toxicity, mostly acne like skin rash.~      A standardized treatment of skin rash is neither established as standard arm for clinical~     trials nor as guideline for the treatment of skin toxicity in clinical practice. While an~     improvement of QoL has been demonstrated for panitumumab and cetuximab in comparison to best~     supportive care the data basis for patient related outcomes regarding skin toxicity deriving~     from randomized trials is still small.~      Recent surveys among German oncologist revealed that physicians are reluctant to use oral~     antibiotics as preemptive treatment . Only 19 out of 110 oncologists stated that they are~     thinking about using preemptive treatment in patients with acne-like skin rash.~      Thus, in the present trial two main questions will be addressed:~      (i) Can preemptive treatment with oral doxycycline be replaced by a sequential skin treatment~     strategy (i.e. local treatment with erythromycin followed by doxycycline in case of~     inefficacy = development of acne) without compromising treatment efficacy of skin toxicity~     treatment? (ii) Comparison of general and skin related QoL between both treatment arms.~   "
145072|NCT01668485|"~     Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic~     control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if~     insulin independence is not achieved. However, the extent and underlying metabolic pathways~     of this improvement are unknown. Investigators therefore compare systemic glucose turnover~     including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring~     islet transplant recipients, matched type 1 diabetic subjects who did not receive islet~     transplantation, and matched healthy non-diabetic subjects.~   "
145073|NCT01668472|"~     Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as~     compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart~     review after delivery.~   "
145074|NCT01668459|"~     A study for patients with confirmed locally advanced or metastatic Transitional Cell~     Carcinoma of the bladder or upper urinary tracts who have developed progressive disease~     within 12 months of their platinum based chemotherapy. The study aims to compare the overall~     response rate of cabazitaxel treatment versus best supportive care including single agent~     chemotherapy.~   "
145075|NCT01668446|"~     The target of this study was an estimate the result of sildenafil on ultrasonographic~     endometrial thickness, endometrial pattern investigation estrogen level on the day of~     progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo~     transfer cycles .~   "
145076|NCT01668433|"~     The emergence of partial artemisinin resistance in Plasmodium falciparum on the Cambodia-Thai~     border and more recently on the Myanmar-Thai border jeopardizes the renewed global efforts of~     control and elimination of malaria. Containment of this severe threat requires reduction of~     transmission of the resistant phenotype by adding gametocytocidal drugs to the treatment of~     falciparum malaria. Mathematical models also predict that transmission blocking will be~     required if the goal of malaria elimination is to be achieved. The only drug currently~     available with strong gametocytocidal properties against the more mature gametocytes is~     primaquine. However, the oxidative properties of primaquine readily causes acute haemolysis~     in glucose 6 phosphate dehydrogenase (G6PD) deficiency, the degree of which appears to be~     inversely related to G6PD enzyme activity. Because of these safety concerns, primaquine is~     not widely deployed in treatment regimens for falciparum malaria, even in areas with~     documented artemisinin resistance. Methylene blue, which does not exert its action through an~     oxidative mechanism, is a promising alternative as a gametocytocidal adjuvant to artemisinin~     combination therapies (ACTs). Paul Ehrlich discovered methylene blue as the first synthetic~     drug ever to treat malaria. In contrast with primaquine, the thiazine dye methylene blue~     asserts its properties as an oxidizing agent only at very high doses, whereas at~     pharmacologic doses it has reducing agent properties and is for this reason used as a~     medication for the treatment of methemoglobinemia. A recent laboratory study identified~     methylene blue as a potent inhibitor of gametocyte development across all stages, almost~     fully abolishing P. falciparum transmission to mosquitoes at concentrations readily~     achievable in humans. In addition, a recent clinical study in 180 children with uncomplicated~     falciparum malaria in Burkina Faso showed that, compared to artesunate-amodiaquine alone,~     addition of the cheap drug methylene blue to either artesunate or amodiaquine importantly~     reduced gametocyte carrier rates measured at days 3, 7, and 14 of follow-up. This effect was~     seen both in patients with and without P. falciparum gametocytaemia at baseline. The current~     series of studies will investigate further methylene blue as a potential gametocytocidal drug~     in the treatment of uncomplicated falciparum malaria.~   "
145077|NCT01668420|"~     The thermal stimulation have been proven effective in upper extremity of stroke patients.~     Therefore, this study explored the efficacy of thermal stimulation in lower extremity of~     stroke patients.~   "
145078|NCT01668407|"~     The effectiveness of non-pharmacological treatment on gait impairment on Parkinson Disease~     (PD) such as exercises has been demonstrated; in particular an example for patient tailored~     exercises is physiotherapy. The goal of physiotherapy treatment is to enable PD patients to~     maintain their maximum level of mobility, activity, and independence. Several systematic~     reviews and clinical studies have shown that physical therapy can contribute to minimize the~     disabling effects of motor and sensory impairments in order to enhance participation in~     societal roles and quality of life. The use of electromechanical devices such as treadmill~     training (a supplement to conventional therapies) in the last years has also been used with~     PD patients and a systematic Cochrane has been conducted by Mehrholz in 2010 to assess the~     effectiveness and acceptability of treadmill training in the treatment of gait disorders for~     patients with PD. In the last years new robotic assisted device can be used in gait training~     in neurological disorder. Till now only few studies, have focused on the effects of~     exoskeleton or end effector robot-assisted training in PD patients, with a interesting~     preliminary results.~   "
145079|NCT01668394|"~     Background: It is well known that cardiac rehabilitation has potential to reduce morbidity~     and mortality, but not all patients complete CR. This LC-REHAB trial aims to compare the~     effect of a new patient education method called learning and coping strategies to that of~     standard care.~      Design: Randomised controlled trial, 1:1 ratio. Participants: Patients above 18 years newly~     hospitalised with either ischaemic heart disease or heart failure.~      Setting: Three hospital Units in Central Denmark Region. Intervention: Cardiac rehabilitation~     with addition of learning and coping strategies which include participation of experienced~     patients as co-educators, clarifuing interviews, and inductive teaching style.~      Control arm: Standard care cardiac rehabilitation with a decuctive teaching style.~      Outcomes: Adherence to cardiac rehabilitation, morbidity, mortality, risk factors, lifestyle,~     health related quality of life, return to work.~   "
145080|NCT01668381|"~     The purpose of this study is to determine the enumeration and function changes of regulatory~     t cells in peripheral blood of hepatocellular carcinoma patients before and 1 week, 4 weeks~     after ablation therapy.~   "
145082|NCT01668355|"~     People with serious mental illness have difficulty making good use of primary care, and die,~     on average, years earlier than others in the population. The greatest contributors to this~     premature mortality are medical illnesses, especially cardiovascular disease and cancer. The~     Patient Centered Medical Home is a model for reorganizing primary care practice so that~     healthcare is more effective, efficient, and user-friendly. It has been implemented across VA~     as the, Patient Aligned Care Team (PACT). It is unclear, however, how this PACT model~     applies to people whose predominant illness is treated by specialists. This is the case for~     people with serious mental illness (SMI), many of whom receive ongoing treatment at mental~     health clinics. To achieve optimal health outcomes in the population with SMI, it may be~     necessary to adapt the PACT model so that it includes approaches that have proven to improve~     healthcare in this population. This project implements an adapted SMI-PACT model, and~     evaluates its effect on Veterans with SMI.~   "
145083|NCT01668342|"~     Mild traumatic brain injury (MTBI) is frequently seen in the ED, post-concussive symptoms are~     common post-injury, and few MTBI patients receive treatment or follow-up for these symptoms.~     Cell phones are ubiquitous, text messaging (SMS) is a cheap and increasingly common form of~     communication, potentially allowing for accurate assessment of symptom patterns after MTBI~     and provision of basic education support . The investigators seek to assess the feasibility~     of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or~     admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based~     symptom reports correlate with phone-based follow-up reports at 14 days and whether~     additional SMS-based educational feedback alters daily symptom patterns.~   "
145084|NCT01668329|"~     Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its~     outcome has not been improved despite the knowledge on inflammatory processes; a reason for~     these lack of results may lay on the lack of data on the precise dynamics of inflammatory and~     anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring~     of the inflammatory process on a small group of non-immunocompromised patients. Our goal is~     to obtain quality data, repeated over time, by limiting the technical variability.~   "
145085|NCT01668316|"~     The purpose of this study is to determine the effectiveness of a worksite diet and exercise~     program on weight loss in postpartum women.~   "
145086|NCT01668303|"~     The objective of the proposed study is to adapt and implement an efficacious adolescent~     substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug~     court service system. Additionally, the investigators will also examine the extent to which~     MDFT can enhance the effectiveness of existing juvenile drug court services in terms of~     decreasing drug use, delinquent behavior and arrests and improving school and vocational~     outcomes. The study design is a fully randomized controlled trial.~   "
145087|NCT01668290|"~     Patients who present with chest pain are investigated with tests designed to confirm or~     exclude the presence of Coronary Artery Disease (CAD), as well as determine risk of poor~     outcome. It is not known which imaging test would be best when used first for investigating a~     patient presenting with exertional chest pain. This trial is designed to compare outcomes of~     the use of coronary CT, stress echocardiography and nuclear perfusion (SPECT) in a pilot~     study. Patients with no history of coronary disease presenting with chest pain will be~     randomly assigned to one of the three test modalities as the initial imaging test. The three~     imaging strategies will be compared regarding the subsequent use of healthcare resources over~     a year.~   "
145088|NCT01668277|"~     Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in~     the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand~     the circulating volume, thus allowing more blood to flow and reducing pressure in the artery,~     vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce~     both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular~     resistance decreases more or to the same degree as the systemic resistance, infusion of~     hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The~     primary objective of this study is to investigate how a clinically relevant dose of~     hypertonic saline affects the systemic and pulmonary circulations in children undergoing~     cardiac catheterization during general anesthesia. This study hypothesizes that an infusion~     of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than~     the systemic vascular resistance.~   "
145089|NCT01668264|"~     Diastolic function is poorly studied in children with congenital heart disease. This is~     mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to~     echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue~     characterization. The main advantage of echocardiography is a better temporal resolution~     which allows the study of short events like early relaxation. Overall there is a lack of~     studies correlating different echocardiographic and MRI parameters of heart function in~     pediatric populations with congenital or acquired heart diseases. This study will address~     specific questions on specific groups of patients that might bring more insight into chamber~     interaction and cardiac function. This study hypothesizes the following:~        -  Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo~          might be the best method for follow-up.~        -  Cardiac remodeling associated with chronic loading results in changes in diastolic~          properties related to changes in cardiac mass and volume. This is related to changes in~          cardiac mechanics influencing diastolic parameters. Especially the influence on twisting~          and untwisting will be studied.~        -  Regional myocardial fibrosis and scarring may account for regional systolic and~          diastolic dysfunction with possible prognostic impact~   "
145090|NCT01668251|"~     The goal of this study is to compare the features of Turner syndrome in girls who are~     diagnosed before birth because of fetal concerns versus those who are diagnosed when their~     mother has an amniocentesis for another reason.~   "
145091|NCT01668238|"~     The purpose of this stage of study is to establish discriminant among healthy tissue, benign~     and malignant thyroid and breast tumors by fourier transform infrared spectrometry variables.~   "
145092|NCT01668225|"~     Recently, scientists look into G-CSF (Granulocyte - Colony Stimulatin Factor). The use of~     this molecule is increasing in reproduction pathology. High level of follicular and blood~     G-CSF on the day of oocyte retrieval could correlate with higher pregnancy and implantation~     rates.~   "
145095|NCT01668186|"~     The Peroxisome Biogenesis Disorders (PBD) are a group of inherited disorders due to defects~     in peroxisome assembly causing complex developmental and metabolic sequelae. In spite of~     advancements in peroxisome biology, the pathophysiology remains unknown, the spectrum of~     phenotypes poorly characterized and the natural history not yet systematically reported. Our~     aims are to further define this population clinically, biochemically and genetically. The~     investigators will prospectively follow patients from Canada, the US and internationally, and~     collect data from medical evaluations, blood, urine and imaging studies that would be~     performed on a clinical care basis. Patients unable to attend clinics can participate in this~     study by mailing in their medical information. The investigators will use this information to~     identify standards of care and improve management.~   "
145096|NCT01668173|"~     The purpose of this study is to test a new drug called AUY922. AUY922 is not FDA-approved.~     AUY922 is a new kind of drug that attacks a protein called HSP90. HSP90 is found in both~     normal and cancer cells, but the investigators think it is more important in cancer cells.~      This study will see if AUY922 helps people with myelofibrosis, essential thrombocythemia and~     polycythemia vera. This study will also see if AUY922 is safe in people with myelofibrosis,~     essential thrombocythemia and polycythemia vera. It will find out what effects, good and/or~     bad, AUY922 has on the patient and the disease. The researchers hope that this study will~     help them to find better treatments for primary myelofibrosis, essential thrombocythemia and~     polycythemia vera.~   "
145097|NCT01668160|"~     The specific aim is to quantify the stability of the acetabular and femoral components of a~     revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In~     this way, the investigators will gain insight into the outcome of the current state of the~     art of revision arthroplasty surgery. In the past, acetabular and femoral component stability~     has been measured using radiostereometric analysis (RSA) and when patients having revision~     total hip operations were compared to patients undergoing primary total hip operations it was~     possible to determine differences in stability and this was predictive of the intermediate to~     long-term performance of the acetabular and femoral reconstruction. The investigators propose~     to use this established, high resolution technique to assess and compare the stability of the~     revision implants.~   "
145098|NCT01668147|"~     The purpose of this research study is to determine the effects of ritonavir and efavirenz on~     the activity of P-glycoprotein in human brain.~      Screening~      Health self-assessment and undergo a medical history and physical examination, including a~     structured interview to screen for history of medical conditions, fasting blood glucose and~     HIV blood tests, urine HCG pregnancy test for women of childbearing potential will be~     performed within 24hr of study drug administration~      Study visits Subjects will be studied on three occasions, with a washout between sessions.~     Sessions 1: Control (no pretreatment) - intravenous administration of 10 - 14 mCi of [11C]~     desmethyl-loperamide (dLop) with PET/CT imaging Session 2: Pretreatment with oral ritonavir~     for 3 days followed by intravenous administration of 10 - 14 mCi of [11C]dLOP with PET/CT~     imaging Session3: Pretreatment with oral efavirenz for 14 days followed by intravenous~     administration of 10 - 14 mCi of [11C]dLOP with PET/CT imaging~   "
145099|NCT01668134|"~     This study is being done to determine if targeted radiation therapy (stereotactic) can be~     given to treat liver cancer, for patient who are unable to undergo surgery, over a short~     period of time with a small amount of side effects.~   "
145100|NCT01668121|"~     The primary objective of this study is to evaluate the acceptance range with which two~     Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting. The~     secondary objective is to compare pharmacokinetic parameters of the reference product batches~     and Budesonide/formoterol Easyhaler.~   "
145101|NCT01668108|"~     The main purpose of this observational study with Paclitaxel is to determine the number of~     treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special~     circumstance of ambulant chemotherapy.~      onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted~     packaging sizes as to decrease the excess quantity to be discarded follows also this~     objective.~      Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison~     to Docetaxel. To this purpose, data regarding co medications and adverse events are also~     collected.~   "
145102|NCT01668095|"~     This research trial studies tumor tissue to identify important proteins and biomarkers from~     patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot~     be cured or controlled with treatment. Studying samples of tumor tissue from patients with~     cancer in the laboratory may help doctors identify biomarkers related to cancer.~   "
145103|NCT01668082|"~     The study is designed to use infusion of a non-radioactive, naturally occurring isotope of~     glucose (13C) in patients undergoing surgical resection for a newly identified brain mass to~     obtain the metabolic phenotype of the tumor, and correlate it with the histopathological~     diagnosis. In each patient, 13C NMR spectral analysis of tumor extracts will be obtained~     after intraoperative infusion of [U-13C]glucose or [1,2-13C]glucose. Whenever feasible,~     patients will undergo 3 preoperative imaging studies - 18FDG-PET, diffusion tensor imaging~     with 1H-spectroscopy on 3T MR scanner, and ultra high resolution MR imaging on the 7T MR~     scanner. The results of these imaging studies will be correlated with the metabolic phenotype~     to generate a comprehensive non-invasive view of the tumor with the goal of identifying~     infiltrative, metabolically active tumor cells within the brain. In addition, a comprehensive~     molecular profile of the tumor will be obtained and enable a genotype-metabolic phenotype~     comparative analysis.~      Correlative Translational Research The investigators will obtain tumor tissue from each~     patient for comprehensive molecular analysis (array CGH, expression profiling, methylation~     profiling) which will be correlated with tumor histology, the metabolites identified by 1H-MR~     spectroscopy and the 13Cglucose metabolic profile. Patients will be followed at designated~     time points along their treatment course to obtain information about ongoing treatment and~     response, time to tumor progression and overall survival. These parameters will be used in~     correlational analysis with the metabolic phenotype.~   "
145317|NCT01665287|"~     Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The~     commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to~     test for their relative sensitivity for low oxygen levels just after birth on term infants~     born by elective cesarean section. Reproducibility will be examined by replacements of the~     sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be~     used.~   "
145104|NCT01668069|"~     Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in~     efficacy to the combination of pyridoxine and doxylamine, the currently recommended first~     line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians~     and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are~     using ondansetron as first line in practice. Despite this practice and the recommendations~     from ACOG, there is not data to suggest that ether practice is superior. This will be the~     first prospective, randomized, double blind, controlled trial comparing the two treatments.~     We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes~     of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely~     benefit from less Emergency Department visits, urgent clinic visits, and admissions for~     progression to hyperemesis gravidarum.~   "
145105|NCT01668056|"~     Ovarian stimulation is an important phase of in vitro fertilization (IVF) treatments. The~     harvest of a larger number of viable eggs per cycle compensate eventual laboratory~     difficulties and allow for the selection of embryos with higher implantation potential. In~     the current protocols, based on the most prevailing theory of ovarian follicular development,~     stimulation drugs are usually started on the second or third day after the beginning of~     menses. The follicular phase of the menstrual cycle is believed to be the only favorable~     moment for follicular development.~      In the early 2000's a new model of human ovarian follicular development (follicular waves)~     has been proposed based on frequent transvaginal ultrasound observations between two~     ovulations. It has been shown that ovarian antral follicles develop in synchronous groups,~     two to three times in a cycle. In fact the follicular wave phenomenon has been initially~     described in the 80's on domestic animals, like the mare and the cow. Moreover, studies in~     these animals have shown that synchronizing the start of the ovarian stimulation drugs with~     the beginning of a follicular wave yields better results for assisted reproductive~     treatments. Consequently in ovarian stimulation protocols for animal assisted reproduction it~     is important to control the initiation of a follicular wave.~      Current protocols of ovarian stimulation for IVF in women do not consider the start of a~     follicular wave to begin drug administration. Therefore the purpose of this study is to~     evaluate two methods to control the emergence of a follicular wave (ovulation induction and~     dominant follicle aspiration) and to investigate the effects of synchronizing ovarian~     stimulation for IVF with follicular wave emergence in women compared to one of the current~     stimulation protocols (flexible GnRH protocol).~   "
145106|NCT01668043|"~     The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting~     the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective~     when multiple doses are administered by intravenous infusion to asymptomatic HIV-1 infected~     adults and to assess pharmacokinetic parameters of the antibody in blood and on cells. The~     neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive~     cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1~     infection.~   "
145107|NCT01668030|"~     Forty percent of patients admitted to the contributing regional burn unit over a five month~     period received facial burns (n=14). The purpose of this study is to examine if the time~     until a granulation bed is well established can be decreased be using an enzymatic agent,~     when compared to a second standard ointment, for patients with partial-thickness facial~     burns. The current study will use a prospective, experimental study design in which each~     individual will be their own matched control. That is, each individual will receive both the~     experimental ointment (one-side of the face) and the standard ointment (other-side of the~     face). Outcomes measured will be the benefits (e.g., decreased in the time until granulation~     bed establishment) one ointment achieves in partial-thickness facial burns when compared to a~     second ointment. Exploratory analyses will examine the relationships among demographic~     variables, granulation bed establishment time, pain, anxiety, itching, and scarring. That is,~     testing whether the time until granulation establishment may be associated with an~     individual's demographic variables, treatment type, pain, anxiety, itching levels, and~     scarring. Significance for all analysis will be at the 0.05 level. The investigators~     hypothesize that promoting rapid granulation bed establishment will decrease hospital length~     of stays, costs, risk of infection, and possibly associated appearance changes. The results~     from the current study will provide preliminary findings for a future, more sophisticated~     study.~   "
145108|NCT01668017|"~     This is a two-part trial. Solid tumor in this protocol means solid tumor excluding~     hepatocellular carcinoma (HCC).~      Part 1: Dose Escalation Phase in subjects with solid tumor (Cohort A) and HCC (Cohort B). The~     dose will be increased from 45 mg twice a day (BID) with 3+3 cohort method up to the~     recommended phase 2 dose (RP2D) of pimasertib established as single agent in the global~     studies for each arm independently.~      Part 2: The Maximum Tolerated Dose (MTD) defined in Part 1 will be confirmed in more subjects~     in Cohort A (N=18) and Cohort B (N=6) separately.~      Following the recommendation by the Safety Monitoring Committee, Cohort B was discontinued~     due to hepatocellular carcinoma (HCC) and there will be no further enrollment of subjects to~     this cohort. This decision is based upon review of safety and efficacy information.~   "
145109|NCT01668004|"~     The objective of this study is to determine the difference in the annual incidence rate of~     uveitis attacks in participants with ankylosing spondylitis (AS) before start initial~     anti-TNF therapy and after treatment with golimumab (GLM).~   "
145110|NCT01667991|"~     Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve~     the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are~     different between countries, will affect the accuracy of etiological diagnoses according to~     the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the~     accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria~     in China.~   "
145136|NCT01667653|"~     This is randomized, double-blind, placebo controlled, single centre; 21 days phase II~     clinical trial on healthy volunteers. Following baseline visit at the day of randomization,~     treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic~     treatment subjects will also receive the study treatment, either probiotic or placebo. Daily~     Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect~     fecal samples for microbiological examination. The primary objective of the study is to~     evaluate the maintenance of intestinal microbiota composition during antibiotic treatment~     with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects~     associated with antibiotic use.~   "
145111|NCT01667978|"~     The purpose of this study is to learn if women taking the atazanavir and ritonavir have lower~     levels of a birth control medication called norethindrone. Norethindrone (also called the~     mini pill) is an FDA (Food and Drug Administration) approved progestin-only birth control~     pill used to prevent pregnancy. Norethindrone is the standard medication used in women who~     take the progestin only pill to prevent pregnancy. There are other birth control pills which~     contain different medications. The investigators want to learn if HIV medications (atazanavir~     and ritonavir) make the blood level of this birth control pill higher or lower. If the levels~     of norethindrone are too low it may not work to prevent pregnancy. The investigators also~     hope to learn about changes in the vaginal fluids and cervical fluids when women are taking~     this birth control pill.~   "
145112|NCT01667965|"~     The purpose of this study is to assess the effectiveness and acceptability of a recently~     created informative video geared for patients who have been evaluated by a radiation~     oncologist for palliative radiation therapy during a hospitalization at Memorial~     Sloan-Kettering Cancer Center. Palliative radiation therapy is radiation therapy that is~     given to patients with the purpose of easing symptoms from cancer. It is not given with the~     intent to cure the cancer. The video presents basic information about palliative radiation~     and palliative care.~   "
145113|NCT01667952|"~     The purpose of this study is to establish a registry of survivors of cancer, tumor, or a~     related illness.~   "
145114|NCT01667939|"~     Nuclear factor kappa B (NF-κB) pathway and oxidative stress participate in endothelial~     dysfunction, which is one of the causes of preeclampsia. Among the human antioxidant~     mechanisms there are the enzymes catalase (CAT), glutathione peroxidase (GPx) and superoxide~     dismutase (SOD). Our aim was to measure NF-κB and oxidative stress in pregnant women~     submitted to an individualized diet during pregnancy.~   "
145115|NCT01667926|"~     Ketamine infusions resulted in an acute reduction in global depression scores and in severity~     of suicidal ideation. The investigators therefore plan to investigate the feasibility and~     efficacy of repeated intravenous administration of ketamine in severely depressed, treatment~     resistant patients. The results of the study could lead to development of new strategies for~     treating depression.~   "
145116|NCT01667913|"~     The purpose of this study is to examine the relative (ICC) and absolute intertester~     reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient~     facility. The data collection is conducted by two physiotherapists, who are blinded to each~     other. The physiotherapists are randomized so they each are doing an equal number of baseline~     tests.~   "
145117|NCT01667900|"~     This is a study of dulaglutide in Chinese participants. The purpose of the study is to~     determine how the body processes dulaglutide and how dulaglutide affects the body. This study~     has 2 parts: Part A - single dose of dulaglutide administered to healthy participants in 2 of~     3 study periods. There is a minimum 28-day washout between periods. Part A will last~     approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants~     with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks.~      Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this~     study.~   "
145118|NCT01667887|"~     The objective of this study is to document callus formation and healing of fractures~     stabilized with locking plates utilizing modern MotionLoc screws that provide controlled~     axial micro-motion to actively promote fracture healing.~   "
145119|NCT01667874|"~     The purpose of this study is to determine if Collatamp, a small flat sponge soaked with~     antibiotics will help to improve the success rate of the treatment of acute joint infections~     after a joint replacement surgery. Our hypothesis is that those patients receiving the~     Collatamp sponges will have an improved success with respect to the eradication of infection~     at one year following treatment.~   "
145120|NCT01667861|"~     The purpose of this study is to determine the impact of playing wind instruments for the~     development of ocular hypertension and glaucoma, together with investigating the prevalence~     of visual problems and eye diseases in (professional) musicians.~   "
145121|NCT01667848|"~     The purpose of this study is to determine the effect of warmed, humidified carbon dioxide~     Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.~   "
145122|NCT01667835|"~     The purpose of this randomized, control pilot study is to measure the effects of a gentle, 12~     week hatha yoga program on post-menopausal, obese, sedentary South Asian women at risk for~     cardiovascular disease. Hatha yoga is a form of structured physical exercises known as~     asanas, combined with breathing exercises called pranayama, and relaxation techniques. The~     yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing~     exercises (pranayama) that can be easily replicated and readily performed by individuals who~     are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.~   "
145123|NCT01667822|"~     Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from~     mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy~     (CBT) has been shown to be an effective treatment of these disorders. Despite the strong~     evidence for CBT there is a lack of evidence-based psychological treatment in primary care.~     For various reasons, the progress of research has not affected clinical practice. For~     successful implementation of CBT in primary care cost-effective therapies, access to~     therapists with proper training and supervision, evidence-based manuals and management that~     support the implementation is needed.~      Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All~     patients are first treated with self-help CBT (N = 400). Patients that do not improve after~     treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based~     on published studies 2/3 is expected to be improved after self-help and therefore do not~     undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to~     individual CBT (N = 67) or continued self-help treatment (N = 67).~   "
145148|NCT01667497|"~     Multiple Sclerosis (MS) patients often complain of cognitive fatigue. There is currently no~     treatment for this symptom. Fampridine SR is a recently approved medication that improves~     walking ability and walking speed in MS patients. It is thought that it might have the same~     positive effect on cognitive fatigue. This study will compare fampridine 10mg twice a day to~     placebo in order to determine if there is any benefit of this medication for cognitive~     fatigue in MS.~   "
145124|NCT01667809|"~     Background: Common mental illness, such as anxiety disorders and depression, is the main~     cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be~     effective in alleviating target symptoms of these disorders, but its effect on sick leave~     rates has not been sufficiently addressed. The investigators have developed an intervention~     called return to work (RTW), which is based in cognitive behavioral theory, that has a~     primary aim of helping sick-listed patients with common mental illness return to work. This~     new treatment has not been evaluated in a randomized controlled trial.~      Aims: The aim of this study is to investigate the effect of CBT and RTW for subclinical~     common mental illness in a randomized controlled trial conducted in primary care.~     Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. Main outcomes~     are days of sick leave and clinician severity rating of psychiatric symptoms. This study~     could contribute to new knowledge regarding how to best treat patients on sick leave with~     mild common mental illness.~   "
145125|NCT01667796|"~     This is a pilot study of oral vitamin D supplementation to determine if patients with~     Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum~     25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or~     relevant gene expression response to oral vitamin D supplementation differs in patients with~     MS and healthy controls.~   "
145126|NCT01667783|"~     Weight loss is effective in reducing many complications of obesity, with the majority of~     patients who undergo bariatric surgery having substantial improvements in their~     weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to~     moderate obesity to compare how losing 10% of initial body weight via one of three common~     weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass~     surgery, and adjustable gastric banding) affects diabetes. While the investigators do not~     expect this pilot study to provide definitive answers, it will provide valuable information~     to design a larger trial which will help guide therapy for people with mild-moderate obesity~     and substantial comorbidities.~   "
145127|NCT01667770|"~     This research study is to find out which types of dural grafts used during surgery for Chiari~     Malformations are superior. We believe that autologous dural grafts are superior to~     non-autologous grafts.~   "
145128|NCT01667757|"~     Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound~     imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES)~     implantation, were used in < 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria~     satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or~     not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was~     proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous~     studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful~     predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging~     criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of~     this study was to investigate angiographic and IVUS parameters in which corresponding FFR and~     evaluate their optimal physiologic criteria after DES implantation.~   "
145129|NCT01667744|"~     Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or~     emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary~     Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In~     addition, behavioral treatment of emotional distress is known to decrease symptoms, and~     treatment usage. The present protocol tests whether the addition of a medication known to~     reduce emotional distress can also reduce symptoms and treatment usage.~      This will done by recruiting patients with ACS during their hospital stay, randomizing them~     to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6~     months.~   "
145130|NCT01667731|"~     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)~     plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are~     coinfected with HIV-1.~   "
145131|NCT01667718|"~     To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and~     without Bismuth for H.pylori treatment.~   "
145132|NCT01667705|"~     -  Rationale: Recently, research that demonstrates a clear relationship between the built~          healthcare environment and the health and wellbeing of patients has come available.~          Patients in a CT scan suite are usually anxious. The environment has been shown to lower~          stress; a painting or piece of art for example, can capture and hold attention and~          thereby lower negative thoughts and evoke positive emotions. Sights of nature have~          demonstrated to be especially effective in recuperating from stress, presumably because~          the human brain has evolved in a natural environment. The current study will investigate~          the effects of exposure to nature in the CT scan suite. A SkyCeiling, a large, slightly~          illuminated, photographic illusion of a real sky view is placed above the CT scan. The~          main hypothesis of this study is that a sky view will lead to a lower level of anxiety~          in the CT scan suite.~        -  Objective: The primary objective of this study is to examine the effect of a view of~          nature on a patient's stress and anxiety. Secondary objectives are to study the effects~          of a view of nature on a patient's environmental appraisals of the CT suite,~          satisfaction with the provided service, and trust in the healthcare provider.~   "
145133|NCT01667692|"~     The Aim of this study is comparison between two regimens containing clarithromycinand~     azithromycin.~   "
145134|NCT01667679|"~     This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through~     the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine~     headaches in 30 minutes after use.~   "
145135|NCT01667666|"~     This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a~     preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human~     research indicate that aerosolized salt water might help reduce harmful inflammation with~     minimal risks.~   "
145180|NCT01667081|"~     This is a three-year (except for participants with chronic kidney disease [CKD] or cirrhosis)~     multicenter study to follow participants who received at least one dose of grazoprevir~     (MK-5172) in a previous study to determine whether they remain hepatitis C virus (HCV)-RNA~     negative over time, and to determine if they have developed antiviral resistance. The study~     will also evaluate long-term adverse events in this population. Participants from MK-5172-052~     (NCT02092350) with CKD or cirrhosis will be followed for five years.~   "
145137|NCT01667640|"~     Microneurosurgical resection of intracerebral metastases leads to prolonged survival and~     relief of symptoms in selected patients.~      To minimize the risk of intracranial recurrence whole brain irradiation has been established~     as standard adjuvant treatment in those patients. Sector irradiation resembles a brain -~     tissue - sparing method by focusing the irradiation in the area of the tumor bed and a~     surrounding 1mm security margin.~      The aim of this study is to investigate whether adjuvant sector-irradiation following~     microsurgical resection is equal to adjuvant whole brain irradiation in terms of local~     control and superior to in terms of quality of life and neurocognitive deficits in a~     prospective randomized trial.~   "
145138|NCT01667627|"~     We present the study design of a clinical trial designed to assess the clinical effects of~     the multispecies probiotic combination BIO-25 in IBS-D patients. To this aim the primary~     endpoints of the study will be improvement in abdominal pain and stool consistency. The study~     will also be designed and powered to investigate the effect of the probiotic BIO-25 on the~     putative inflammation-associated parameters related to microinflammation in IBS, using~     postulated improvements in Hs-CRP, and calprotectin as markers of that effect. Additional~     aims of the study will examine the possible effect of probiotic BIO-25 on the cholinergic~     status.~   "
145139|NCT01667614|"~     The detrimental effects of aldostrone are not adequately arrested by the use of angiotensin~     converting enzyme (ACE), angiotensin II receptor blocker (ARB) or a combination of both.~     Recent evidence has provided robust evidence that aldostrone escape plays an important role~     in this regard. It is believed that aldostrone escape occurs quite commonly with reports~     indicating prevalence rates as high as 22% with ARBs and 40% with ACE inhibitors. In a trial~     of patients with diabetes and hypertension it was shown that treatment of aldostrone escape~     with spironolactone 25 mg daily for three months significantly reduces proteinuria. A number~     of other trials have similarly observed that addition of spironolactone to an ACE inhibitor~     based regimen provides additional benefits on proteinuria reduction, blood pressure control,~     and prevention of glomerular filtration rate (GFR) decline. Most of the available trials in~     this regard are of short duration (e.g. three months), and have added spironolactone to an~     ACE or ACE+ARB based regimen (the so-called triple blockade). Currently, evidence evaluating~     efficacy of a combined ARB+spironolactone regimen compared with conventional double RAS~     blockade (i.e. ACE+ARB) is lacking. Hence, this randomized open label trial was initiated to~     determine the effects of addition of spironolactone 25 mg daily to losartan over a period of~     18 months.~   "
145140|NCT01667601|"~     Only a few intervention studies have also focused on changing patients' negative thoughts and~     feelings towards the illness and their relationship to the suffering caused by those~     thoughts, which is evidenced to empower psychosocial functioning and control of distressing~     thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress~     Reduction program. This controlled trial is designed to test the effects of a~     mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia~     on their symptom severity, illness insight and psychosocial functioning.~   "
145141|NCT01667588|"~     Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with~     a reported prevalence of 60-80%. To date three studies have reported on SDs in children with~     CKD but these have all been based on questionnaire data alone. The findings were not~     confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a~     validated tool to assess the sleep/ wake cycle over a prolonged period in the home. This is~     highly relevant given the poor sensitivity and specificity of even validated questionnaires~     alone. The effect of untreated pediatric SD is pervasive. This study will provide the first~     objective assessment of SDs using PSGs in children with severe CKD, both on and off dialysis.~     Therefore, we will recognize and when possible treat SD in this severe CKD cohort potentially~     contributing to their immediate management (eg improved control of hypertension, improved~     school performance), while improving their Quality of Life (QOL) and helping ensure they~     achieve their full potential.~   "
145142|NCT01667575|"~     The purpose of this study is to observe the efficacy of ten day triple therapy-based,~     bismuth-containing quadruple therapy for H.pylori treatment.~   "
145143|NCT01667562|"~     This open-label, multi-center study will evaluate the progression-free survival and safety of~     erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with~     activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor~     (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or~     unacceptable toxicity.~   "
145144|NCT01667549|"~     The goals of the proposed research are to specify the timing and consequences of the~     sensitive period for flavor learning in infants who are being breastfed or formula fed. The~     investigators will conduct a randomized within- and between-subject study of women and their~     infants during a 15-month window.~   "
145145|NCT01667536|"~     This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and~     performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic~     lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI~     were also assessed, as judged by histopathology results.~   "
145146|NCT01667523|"~     An altered permeability has been proposed to play an important role in the pathogenesis of~     several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel~     disease. Nutrients derived from food are able to influence the permeability of the intestine~     and can therefore also affect gastrointestinal symptoms. In this study, the investigators~     will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot~     peppers and cinnamon, respectively, on gastrointestinal physiology.~      Objective:~      To obtain more information about the effects of capsaicin and cinnamaldehyde on the~     intestine, these substances will be infused directly in the duodenum. Hereafter, the~     permeability of the intestine, gallbladder motility and the effects on satiety will be~     assessed.~      Hypothesis:~      Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial~     barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin~     from enterochromaffin cells as determined by the multi sugar permeability test~   "
145147|NCT01667510|"~     The hypothesis of the study is that supplementation with Cardio Mato (a Tomato Extracted~     Lycopene)for 12 weeks will decrease the blood pressure of subjects with prehypertension~     compared to Placebo.~   "
145149|NCT01667484|"~     Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis~     (MS) and can occur independently of physical disability. It is the most common reason, along~     with physical fatigue, for MS patients to stop working. The most frequent complaint is~     problems with multi-tasking or thinking quickly, which corresponds to impairment in the~     cognitive domain of processing speed. Currently there is treatment available to prevent~     relapses and physical disability but there are no medications that have been shown to treat~     cognitive impairment. Amphetamines have been beneficial for selective attention and~     processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain~     injury. This is study will determine whether Adderall XR improves objective measures of~     processing speed and attention in MS patients impaired in this cognitive domain, by comparing~     two doses of Adderall XR (5 and 10mg) to placebo before and after the medication is~     administered. The results of this study will help provide data to design a larger study to~     determine if Adderall XR, and potentially other amphetamine drugs, will help treat cognitive~     impairment in MS patients.~   "
145150|NCT01667471|"~     This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra~     (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who~     completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical~     response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra~     8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.~   "
145151|NCT01667458|"~     This observational study will evaluate the presence and evolution of fatigue on treatment~     with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis~     who have an inadequate response to at least two DMARDs (one of them methotrexate) or to~     anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg~     intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.~   "
145152|NCT01667445|"~     The purpose of this study is to determine the contribution of spinal epimorph to patient's~     perioperative pain management in Total Knee Arthroplasty (TKA). This study is designed to~     determine whether spinal epimorph and its associated complications is a necessary addition to~     provide adequate analgesia given the multimodal approach to pain management. It is~     hypothesized that perioperative local infiltration with a cocktail of local and systemic~     analgesics will provide equal analgesia to patients who are given both local infiltration and~     spinal epimorph perioperatively.~   "
145153|NCT01667432|"~     This prospective, multicenter, observational study will evaluate on-treatment predictors of~     response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving~     treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the~     summary of product characteristics. Data will be collected from patients for the duration of~     their treatment and for up to 24 weeks thereafter.~   "
145154|NCT01667419|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF~     mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two~     separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA~     (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in~     diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer~     (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC~     cutaneous melanoma, as defined by this classification scheme. Within each cohort,~     participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a~     52-week period.~   "
145155|NCT01667406|"~     Infertility affects one in six couples in the United Kingdom (UK) and has devastating~     physical, social and emotional consequences for affected couples. In vitro fertilisation~     (IVF) treatment is now widely and successfully used to enable infertile couples to conceive.~     However, IVF treatment can result in the potentially life threatening condition, ovarian~     hyperstimulation syndrome (OHSS). Mild forms of OHSS occur in approximately 1 in 3 of all IVF~     cycles, whilst approximately 1 in 10 IVF cycles result in moderate or severe OHSS. OHSS is~     caused by the use of human chorionic gonadotrophin (hCG) used in IVF treatment to stimulate~     oocyte (egg) maturation. Kisspeptin is a hormone which stimulates reproductive hormone~     secretion and is responsible for the release of reproductive hormones which result in oocyte~     maturation and ovulation (the release of an egg from the ovary). The significant advantage of~     kisspeptin over current treatments to stimulate ovulation, is that it would stimulate a more~     physiological increase in reproductive hormones and oocyte maturation during IVF treatment.~     The aims of this project are to investigate whether administration of kisspeptin to women can~     result in oocyte maturation.~   "
145156|NCT01667393|"~     Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the~     IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive~     atherosclerotic popliteal artery disease.~   "
145157|NCT01667380|"~     This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene~     glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on~     dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.~   "
145158|NCT01667367|"~     This single-center, single-blind, placebo-controlled, parallel-group study with crossover~     component will evaluate the GABAAalpha5 receptor expression, occupancy and functional~     connectivity in the brains of individuals with Down syndrome and healthy controls following~     single dose RG1662. Participants will receive a single dose of placebo before the imaging~     session (PET and MRI), and a single dose of RG1662 before the second imaging session.~   "
145159|NCT01667354|"~     The primary aim of this trial is to test the effectiveness of an intervention to train~     primary care physicians to determine if it leads to decreased parental vaccine hesitancy.~   "
145206|NCT01666743|"~     The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in~     elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic~     therapy in the hospital.~   "
145318|NCT01665274|"~     The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative~     chemotherapy is superior or not to operation directly for locally advanced gastric cancer in~     terms of 3 year disease-free survival (DFS) rate.~   "
145160|NCT01667341|"~     Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts~     of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each~     cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:~        1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)~        2. GEN-003: Antigens alone~        3. Placebo (DPBS diluent)~      Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot~     Group. Immunization of the remainder of the Group Continuation Group) is contingent upon~     successful review of data from the Pilot Group through Day 7 after immunization. Dose~     escalation to the next dose level Cohort proceeds after evaluation of safety data from all~     patients in the prior Cohort and only after all specified safety criteria are met. The total~     numbers of patients in each Group and Cohort are as follows:~        -  10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)~        -  30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)~        -  100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)~        -  Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)~      Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at~     3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done~     twice daily for 28 days prior to the first immunization (baseline shedding), and again~     following the last immunization. Follow-up for safety monitoring will be conducted for 12~     months after the last immunization.~   "
145161|NCT01667328|"~     This randomized controlled interventional study is designed to determine whether breast~     cancer surgical patients receiving presurgical massage therapy performed by a licensed~     massage therapist have decreased average anxiety levels compared to the control group of~     breast cancer surgical patients who do not receive massage therapy.~   "
145162|NCT01667315|"~     The use of ultrasound in regional anesthesia enables reduction in the local anesthetic~     volume. The present study aimed to determine the minimum effective volume of 0.375%~     bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery.~     Following approval by the Research Ethics Committee, patients with a physical condition of I~     or II according to the American Society of Anesthesiologists, between 21 and 65 years old and~     subjected to elective surgery of the shoulder and interscalene brachial plexus block will be~     recruited. The volume of the anesthetic will be determined using a step-up/step-down method~     and based on the outcome of the preceding block. Positive or negative block results in a 1mL~     reduction or increase in volume, respectively. The success of the block is defined as the~     presence of motor block in two muscle groups and the absence of thermal and pain sensations~     in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic paralysis,~     pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours. Data will~     undergo statistical analysis in order to determine minimum effective volume of 0.375%~     bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic function,~     evaluate diaphragm paralysis and its influence in pulmonary function.~   "
145163|NCT01667302|"~     The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy~     followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.~   "
145164|NCT01667289|"~     The purpose of this study is to prove the superiority of concurrent chemoradiation compared~     with radiotherapy alone in patients with low risk NK/T-cell lymphoma.~   "
145165|NCT01667276|"~     This is an observational study to assess the experience of current depot medroxyprogesterone~     acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject~     and offer recommendations for the introduction of this method.~   "
145166|NCT01667263|"~     Randomized, open-label, multicentre study to compare the efficacy and safety of ATRA plus~     danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.~   "
145167|NCT01667250|"~     The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled~     pilot study is to study feasibility and collect preliminary clinical data related to the~     safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the~     GammaCore device for the prevention of chronic migraine, and to support the development and~     approval of a larger pivotal study.~   "
145168|NCT01667237|"~     The general objectives of this study are to verify the feasibility of a short home-based~     rehabilitation program for cancer patients prior to lung resection surgery, and to quantify~     its effects on aerobic capacity, exercise tolerance and skeletal muscle strength.~      Therefore, the hypotheses of this study are that:~        1. Implementation of a short home-based rehabilitation program (4 weeks) based on exercise~          training is feasible and safe in patients with lung cancer resection candidates.~        2. Compared to control patients, patients included in the home-based rehabilitation program~          will improve significantly their aerobic capacity, exercise tolerance and arms and legs~          muscle force.~   "
145169|NCT01667224|"~     Obesity is a major health issue worldwide; there is a constant raise in obesity related death~     each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent.~     However, the efficacy and safety of Actiponin supplementation on body weight regulation in~     humans are lacking.~   "
145170|NCT01667211|"~     Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis~     cervical cancer, to evaluate the efficacy and toxic reaction.~   "
145171|NCT01667198|"~     Professional societies recommend that endoscopists measure their ceacal intubation rate,~     adenoma detection rate as indicators of the screening colonoscopy quality. However, it is~     uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability in~     the detection of adenomas. The investigators hypothesize that a hands-on-training~     intervention tailored to the results of environmental assessment and audit on colonoscopy~     quality indicators results in higher adenoma detection rate improvement than simple audit and~     feedback. The investigators further hypothesize that by training the leaders of the screening~     centres, the effect of the intervention will be further disseminated among other endoscopists~     from the participating centers, and will thus result in additional increase in individual~     adenoma detection rate.~      The primary aim is to compare the impact on adenoma detection rate of two screening~     colonoscopy improvement programs:~        1. Tailored training intervention.~        2. Audit feedback on colonoscopy quality indicators.~   "
145872|NCT01657747|"~     The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a~     non-invasive method for~        -  accurate staging of patient suspected having ovarian cancer~        -  early treatment assessment~        -  detecting tumor recurrence~   "
145172|NCT01667185|"~     The primary objective of the study is to evaluate the safety and effectiveness of the G4~     System (System) when used as an adjuvant to blood glucose testing over a 7-day period in~     pediatric subjects with diabetes mellitus.~      System effectiveness will be primarily evaluated with comparison to laboratory reference~     Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be~     evaluated in terms of point and rate accuracy of the system in reference to YSI. The point~     accuracy is measured as the proportion of G4 System values that are within ±20% of YSI~     reference value for glucose levels >80 mg/dL and ±20 mg/dL at YSI glucose levels <80 mg/dL.~     The trend accuracy of the device performance, i.e., continuous glucose error grid analysis,~     will be evaluated as well as the temporal accuracy at different glucose rates of changes and~     different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary~     matched paired (Sensor-YSI) measurements will be collected during one in-clinic session.~     System effectiveness will also be evaluated with SMBG measurements similarly.~      Safety data of the system will also be collected and safety will be characterized by the~     incidence of Adverse Device Effects (ADE) experienced by study participants.~      Other objectives include the evaluation of device performance at an alternate site (the upper~     buttocks).~   "
145173|NCT01667172|"~     Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive Protein~     devices (POC CRP devices) in comparison with laboratory CRP testing on children and adults.~      Research questions:~        1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP~          values measured at the clinical laboratory?~        2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable?~          2.1.1. Comparison of 2 measurements in the same patient on 1 device~          (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on~          2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices~          equally userfriendly in a general practice surgery? (userfriendliness~   "
145174|NCT01667159|"~     This study will examine the effectiveness of an integrated treatment for adolescents who are~     depressed and use alcohol in an intensive outpatient setting in the community.~   "
145175|NCT01667146|"~     Some people develop the condition called acute respiratory distress syndrome (ARDS). This is~     a condition where the lungs have become injured from one of a number of various causes, and~     do not work as they normally do to provide oxygen and remove carbon dioxide from the body.~     This can lead to a reduced amount of oxygen in the patient's bloodstream. Patients with ARDS~     are admitted to the intensive care unit (ICU) and need help with their breathing by being~     connected to a ventilator (breathing machine). ARDS can lead to injury in other organs of the~     body causing other problems but also death.~      Over the past few years, reducing the size of each breath delivered by the ventilator in~     conjunction with the use of an occasional sustained deep breath called a recruitment~     manoeuvre have been used to try to prevent further damage to the lungs in people with ARDS.~     This ventilator strategy (termed the PHARLAP strategy) has been shown in a small research~     study to have some beneficial effects without causing any obvious harm, when compared to a~     current best practice ventilator strategy. The main beneficial effects of the PHARLAP~     strategy were to increase the amount of oxygen in the blood and to reduce markers of~     inflammation (the body reacting to a disease process) in the body. This study was too small~     to make a strong conclusion, so this study will be much larger and will assess whether~     patients who have developed ARDS are better off when we use the PHARLAP strategy. Three~     hundred and forty patients will be enrolled into this study in multiple ICUs across Australia~     and New Zealand.~      The study hypothesis is that the PHARLAP strategy group will have a higher number of~     ventilator free days at day 28 than the control group.~   "
145176|NCT01667133|"~     The purpose of this study is to assess the safety and efficacy of ponatinib in Japanese~     patients with chronic myeloid leukemia (CML) who have experienced failure of dasatinib or~     nilotinib or with Ph+ acute lymphoblastic leukemia (ALL) following failure of prior tyrosine~     kinase inhibitors (TKIs).~   "
145177|NCT01667120|"~     The general purpose of this study is to characterize the safety profile of ketorolac in~     infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective~     in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg~     intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9%~     normal saline as placebo.~      Primary: The primary purpose of this study is to compare bleeding events in neonates who~     receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that~     ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.~      Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine~     output per shift, platelet counts, hemoglobin levels, number of days on the ventilator,~     amount of narcotic administered, blood pressure, and reintubation events on all patients in~     this study as secondary study points.~   "
145178|NCT01667107|"~     This single site study will examine plasma and alveolar compartment (AC) levels of~     posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant~     recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal~     infection rates will be assessed following transplantation.~   "
145179|NCT01667094|"~     Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of~     secretions, especially in the lungs. By adulthood, the majority of patients with CF will have~     a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung~     infections. This usually results in worsening respiratory symptoms and often an acute~     deterioration in their lung function. They are usually treated with antibiotics that target~     the Pseudomonas aeruginosa. These antibiotics are typically given as short intravenous~     infusions several times a day. This study aims to compare the standard method of giving these~     antibiotics with a different strategy of giving these antibiotics to see if this can improve~     the outcomes of treatment of these infections and reduce the amount of Pseudomonas aeruginosa~     in the lungs of these patients. This strategy consists of giving the same antibiotics~     continuously, to ensure there is always enough antibiotic in the bloodstream and the lung to~     be able to kill the bacteria.~   "
145319|NCT01665261|"~     The purpose of this study is to test the accuracy of 7 indicators in screening congenital~     heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these~     indicators could be applied in the nationwide newborn CHD screening. The investigator's~     hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable~     accuracy.~   "
145181|NCT01667068|"~     Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is~     rising. Different cohorts are observing an increased risk for cardiovascular diseases in this~     aging HIV-infected population. Traditional cardiovascular risk factors like smoking are more~     frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection and~     metabolic disorders also caused by some antiretroviral substances as special non-traditional~     risk factors in HIV-infected persons can influence the development of cardiovascular diseases~     additionally. Therefore new research focus in special risk profile associated with~     HIV-infection or antiretroviral treatment and prevention for HIV-infected patients is~     developing.~      This present study is an ongoing prospective regional multicenter trial that was conducted to~     analyse the incidence, prevalence and clinical course of cardiovacular disorders in~     HIV-infected out-patients.~      Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion, pulmonary~     hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial endocarditis and~     heart valve disorders. In addition to previously stated disorders of the heart, the premature~     atherosclerosis of coronary arteries, a further even more important disease of the heart in~     this patient population, went into the focus of most HIV-researchers and physicians.~   "
145182|NCT01667055|"~     The true prevalence of drug allergy in patients with a history of penicillin/aminopenicillin~     allergy will be determined by using commercially available standard skin test reagents and~     the diagnostic agents available in Thailand. We hypothesize that only minority of patients~     with such a history are truly allergic.~   "
145183|NCT01667042|"~     This is a mechanistic research study to evaluate the relationship between cough, reflux, and~     aspiration in patients with systemic sclerosis (scleroderma).~   "
145184|NCT01667029|"~     The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid~     arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this~     study, the investigators will evaluate whether sulfasalazine improves pain due to painful~     peripheral neuropathy.~   "
145185|NCT01667016|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
145186|NCT01667003|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
145187|NCT01666990|"~     HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually~     leads to clinically significant immunodeficiency. A chronic generalized immune activation is~     now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1~     immunity and disease progression during chronic HIV-1 infection. However, it is still unknown~     whether reducing immune activation will restore CD4 T cell counts and leading to immune~     reconstitution in chronic HIV infection. Tripterygium Wilfordii Hook F (TwHF) has been~     demonstrated to decrease immune activation of the host, and can suppress inflammation in~     human diseases. Here, the investigators propose a hypothesis that TwHF can reduce immune~     over-activation which subsequently leads to the restoration of CD4 T-cell counts and immune~     reconstitution in HIV-infected immune non-responders.~   "
145188|NCT01666977|"~     The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug~     measuring progression free survival.~   "
145189|NCT01666964|"~     We would like to ascertain the prevalence of hypopituitarism after combat-related TBI. This~     will lead to enhanced awareness, recognition, and treatment of hypopituitarism, which can~     have life-saving ramifications and enhance quality of life and rehabilitation efforts in our~     combat veterans.~   "
145190|NCT01666951|"~     The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets~     administered once-daily compared to Prograf capsules administered twice-daily after kidney~     transplantation.~   "
145191|NCT01666938|"~     The purpose of this study is to investigate the effects of phone counselling support as a~     strategy to increase physical activity in people with diabetes.~   "
145192|NCT01666925|"~     Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials become~     more widely available. However, transmission still persists and it appears that additional~     control measures are required. The leading malaria vaccine candidate in development is RTS,S~     which has efficacy against clinical malaria measured at 30-50% in the field. This partial~     protection might be enhanced by combination with other components. The other vaccination~     approach that has produced repeatable efficacy in humans is the use of viral vectors to~     induce T cell responses. Previous attempts with this vaccine approach have been effective in~     challenge studies in Oxford, but ineffective in the field, probably because of reduced~     immunogenicity.~      Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity~     by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified~     vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with~     thrombospondin- related adhesion protein (ME-TRAP).~      The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and~     partial protection in 5 out of 14 volunteers in challenge studies.~      The investigators propose a Phase 2b study of 120 healthy adult men in Kenya. The~     investigators will assess the efficacy and further evaluate the immunogenicity and safety~     profile of the vaccine regimen. The investigators also intend to assess the correlates of~     efficacy and natural immunity.~   "
145193|NCT01666912|"~     This is a prospective study comparing two groups of 48 adolescent women each. The~     intervention group will receive a contraceptive implant postpartum, prior to discharge from~     the hospital. The control group will receive a contraceptive implant at the usual 6 week~     postpartum clinic visit. During prenatal care, participants will be consented and screened~     for enrollment. After delivery, these women will be assessed and consented for enrollment~     into the study. Women who consent for enrollment will be randomized. Women will be followed~     up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each~     follow up, women will be assessed for continuation of and satisfaction with this method of~     contraception.~   "
145194|NCT01666899|"~     The purpose of this study is to investigate the effects of radiation therapy following~     mastectomy on skin and blood vessels and to use information gathered to determine an ideal~     time for breast reconstruction after radiation.~   "
145320|NCT01665248|"~     The purpose of this study is to evaluate the correlations between active calcification and~     vulnerable plaque.~   "
145195|NCT01666886|"~     In the protocol Predicting therapeutic outcome of mandibular advancement device treatment in~     obstructive sleep apnea (PROMAD), 100 patients with obstructive sleep apnea are included and~     started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography~     with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results~     of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD~     in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the~     most effective protrusion should be a weighted compromise between efficacy and side-effects~     of MAD therapy.~      In patients with insufficient results on the polysomnography with the MAD at 75% of maximal~     protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at~     the follow-up visit after the polysomnography with the MAD. After habituation and adaptation~     period but within 2 months after the first polysomnography with MAD, a new polysomnography~     will be performed to assess the effect of the 90% protruded position.~   "
145196|NCT01666873|"~     Evaluation of the clinical results after total knee prosthesis, and correlation with the~     alignment of the lower limb.~      Radiological measurements by means of 3D technology will be performed. The clinical result~     will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee~     score-questionnaire).~   "
145197|NCT01666860|"~     During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior~     Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of~     the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed~     and replaced by a bone graft. These patients form the population of this study. The goal of~     this study is to evaluate their current medical condition and to determine the clinical~     outcome.~      The clinical result will be stipulated by means of standardized questionnaires (VAS-score,~     Oswestry low Back Pain Questionnaire and SF-36)~   "
145198|NCT01666847|"~     Milking the umbilical cord from the placental end toward the infant has been shown to benefit~     preterm infants when compared to either clamping the umbilical cord immediately or waiting~     delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown~     to improve heart and lung function, reduces the need for blood transfusion, and reduces the~     risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical~     cord, however in extremely premature infants is not considered safe, since it also delays the~     resuscitation that these infants need immediately after birth. Milking the umbilical cord is~     believed have similar benefits to delaying the clamping of the cord, but can be done much~     faster (seconds rather than minutes). In this study, the cord will milked three times over~     about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for~     routine care. Participants of this study will be randomly assigned to one of two study~     groups: the first group will have the cord milking intervention and the second group will not~     have any intervention other than routine, immediate cord clamping with routine care of mother~     and infant. Data will be collected about the mother prior to delivery and data will also be~     collected about the baby using computerized health records. The data will look at short term~     changes in red blood cell volumes, the need for blood transfusions, and rates of known~     complications of prematurity, including longer term developmental complications at 18-24~     months.~      The hypothesis is that milking the umbilical cord before cutting the cord will lead to a~     higher hemoglobin concentration and decrease the need for blood transfusions in extremely~     preterm neonates compared to the current standard of immediately clamping the umbilical cord.~   "
145199|NCT01666834|"~     The characteristics and outcomes of a mixed group of critically ill patients who received~     mechanical ventilation are not known in China.~      A 1 month Cross-section survey will be performed with the aim of describing the~     characteristics and outcomes of conventional mechanical ventilation and treatment of acute~     respiratory distress syndrome in intensive care units in China.~   "
145200|NCT01666821|"~     To investigate pathomorphological and functional variations of choroidal neovascularization~     (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical~     coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative~     AMD.~   "
145201|NCT01666808|"~     Prostate cancer is the most common solid tumor, with approximately 200,000 new cases~     diagnosed per year. Several different local therapies are available for treatment, including~     surgery and radiotherapy Significant advances have been made in the technical aspects of~     surgery and of radiotherapy which have improved both the cancer control outcomes as well as~     the morbidity of treatment. Despite these significant advances, approximately 30% of patients~     treated with definitive local therapy experience recurrent disease. Recurrent disease after~     prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA~     level is often of limited use in differentiating local recurrence (ie. recurrence in the~     prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence).~      One PET radiotracer which has shown promise in the staging and restaging of patients with~     prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid~     (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher~     accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with~     suspected recurrent prostate carcinoma.~      The major goal in this proposed investigation is to use advanced molecular imaging to better~     guide post-prostatectomy decision making, in terms of guiding the decision to deliver~     radiotherapy, and in terms of the exact areas treated with radiotherapy.~      Investigators will perform a study with 162 patients in whom there is a strong suspicion of~     prostate cancer that has returned to the body after having a prostatectomy. Half of these~     patients will have radiotherapy decision-making and delivery per the usual routine, and half~     of these patients will have the radiotherapy decision and volumes guided by the FACBC test.~     The major goal of the investigation is to see whether the FACBC improves the selection and~     the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.~   "
145202|NCT01666795|"~     The objective of this human study was to evaluate the association between the specificity of~     anti-platelet autoantibodies and response to IVIG treatment.~   "
145203|NCT01666782|"~     The safety and immunogenicity of high dose influenza vaccine has not been studied in young~     patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and~     safety of high dose influenza to standard dose influenza vaccine in adult oncology patients~     who are younger than 65 years old receiving chemotherapy.~   "
145204|NCT01666769|"~     Determine proper dosing of micafungin in children supported with extracorporeal membrane~     oxygenation (ECMO).~   "
145205|NCT01666756|"~     This phase I trial studies the side effects and best dose of Chinese herbal formulation~     PHY906 when given together with sorafenib tosylate in treating patients with advanced liver~     cancer. Biological therapies, such as Chinese herbal formulation PHY906, may interfere with~     the growth of tumor cells and slow the growth of tumors. Sorafenib tosylate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib~     tosylate may also stop the growth of liver cancer by blocking blood flow to the tumor. Giving~     Chinese herbal formulation PHY906 together with sorafenib tosylate may work better in~     treating advanced liver cancer.~   "
145207|NCT01666730|"~     This phase II trial studies how well metformin hydrochloride, leucovorin calcium,~     fluorouracil, and oxaliplatin work in treating patients with metastatic pancreatic cancer.~     Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil,~     and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving metformin hydrochloride together with~     combination chemotherapy may kill more tumor cells~   "
145208|NCT01666717|"~     The purpose of the study is to evaluate fecal metabolites profiles of Inflammatory Bowel~     Disease(IBD) patients versus healthy controls (HC).~   "
145209|NCT01666704|"~     The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic~     plaque inflammation~   "
145210|NCT01666691|"~     The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for~     certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly~     subcutaneous injections for 12 weeks.~   "
145211|NCT01666678|"~     The purpose of the current trial is to evaluate the bioavailability of a single oral dose of~     naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently~     marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or~     DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.~   "
145212|NCT01666665|"~     Massive pediatric burns are associated with a persistent and sustained hypermetabolic~     response characterized by elevated levels of circulating catecholamine's, cortisol, and~     glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound~     healing. Insulin and metformin have demonstrated anabolic activity with minimal associated~     side effects. However, it is unknown whether the beneficial effects arise from tight~     euglycemic control or direct effect of insulin action. We hypothesize that during acute~     hospitalization, administration of metformin at a dose titrated to maintain blood glucose~     between 80-180 mg/dl will accelerate wound healing and recovery in children with severe~     thermal injury and will have beneficial long-term effects on muscle strength, immune~     function, and wound healing.~   "
145213|NCT01666652|"~     The study is designed to afford a first time in humans (FTiH) safety and immunogenicity~     assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine~     candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or~     AS03B (adjuvants used in Glaxo Smith Kline (GSK) Biologicals' hepatitis B candidate vaccine,~     malaria candidate vaccine and pandemic flu vaccine, respectively). Each vaccine candidate~     will contain 1 µg of purified virus antigen per each of the four DENV types. Additionally,~     the study will evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of~     purified virus antigen per each of the four DENV types. The control group will receive a~     saline placebo. All experimental vaccinations will be administered according to a 2-dose~     schedule, 28 days apart.~   "
145214|NCT01666639|"~     Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain~     has proven its short-term effectiveness. Exercise therapy plays a major role in such a~     combination of treatments. There is a considerable need to develop theory-based exercise~     interventions which foster a long-term adherence to physical activity. Furthermore, an~     integration of behavioral elements such as coping competencies regarding back pain is needed.~     It is not yet clear, which specific part of multidisciplinary rehabilitation causes its~     effects. The role of exercise therapy has yet to be investigated. Aim of this study is the~     implementation of a standardized behavioral exercise therapy into an existing~     behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is~     that the participation in the behavioral exercise therapy leads to greater short- and~     long-term improvements in functional capacity compared to the usual care.~   "
145215|NCT01666626|"~     The purpose of this study is to determine whether ultrasound-based assessment of intestinal~     stiffness in patients with Crohn's disease predicts the effectiveness of medical therapy or~     the need for surgical resection.~   "
145216|NCT01666613|"~     The purpose of this study is to look at drug levels of AZD8683 in blood when the drug is~     administered in different ways - orally, intravenously or inhaled (with two different~     devices), to healthy subjects~   "
145217|NCT01666600|"~     Patients with glioblastoma at first or second progression who have failed standard treatment~     that must have included radiochemotherapy with temozolomide and who are a candidate for a~     reirradiation can be included into the trial. In the phase I part the minimal tolerated dose~     (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II~     will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.~   "
145218|NCT01666587|"~     The purposes of this study are two-fold. The first purpose is to determine the effect of~     taking vitamins on the recovery of an artery (blood vessel) following an induced temporary~     injury. The second purpose is to determine whether a specific vasodilator is less abundant~     after the injury and whether this contributes to increased constriction or after the injury.~     Finally, does vitamin consumption have an effect on the recovery from the injury if one of~     the substances in the blood that causes vessels to enlarge (dilate) is stopped?~   "
145219|NCT01666574|"~     This study is to determine if two breakfasts of equivalent calories, an oat based breakfast~     cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also~     determine if the two calorically equivalent oat-based breakfast cereals give different~     caloric intakes at a lunch meal that participants will eat to their satisfaction.~   "
145220|NCT01666561|"~     To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an~     equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety~     over the 4 hour period following breakfast.~   "
145254|NCT01666119|"~     This is an open label study in opioid dependent subjects maintained on a stabilized dose of~     Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA~     Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized~     on Suboxone (buprenorphine/naloxone) tablets or films.~      Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.~     This dose will be taken throughout the 12-week treatment period with dose adjustments as~     clinically indicated for either the control of opioid dependence or adverse events (AEs).~   "
145255|NCT01666106|"~     Osteonecrosis of the Jaw (ONJ) Case Registry~   "
145221|NCT01666548|"~     The purpose of this study is to investigate the clinical, cognitive outcome and psychosocial~     outcome of haemolytic uraemic syndrome in childhood.~      The haemolytic uraemic syndrome (HUS) is the leading cause of acute renal failure in~     childhood. The more common typical HUS is mostly caused by Shigatoxin-producing~     enterohaemorrhagic Escherichia coli (EHEC). The rarer atypical HUS is mainly caused by~     different genetic abnormalities in complement regulatory proteins.~      About 50 till 60 percent of all patients with HUS develop a severe acute renal failure and~     require dialysis. Resulting from new diagnostic and therapeutic approaches the survival rate~     increased during the last years. Despite this, there are only few data concerning long-term~     prognosis, cognitive and motoric development, as well as psychological coping and~     health-related quality of life of affected children and their parents.~   "
145222|NCT01666535|"~     The investigators will compare the immunogenicity of influenza vaccine in adults and children~     with inflammatory bowel disease by timing of vaccine in relation to maintenance infliximab~     dosing. The primary objective is to compare the proportion of IBD patients on maintenance~     infliximab who mount serologic protection to each component of the influenza vaccination~     between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients~     vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection~     will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary objective is to~     compare the proportion of IBD patients who mount an immunogenic response (≥ 4-fold increase~     from pre to post-vaccination titer) to each component of the influenza vaccination between~     patients vaccinated on day of infliximab infusion and those vaccinated at the mid-point.~   "
145223|NCT01666522|"~     In the present study the aim was to determine the prevalence of sarcopenia and to evaluate~     the effectiveness of an exercise program and vitamin D supplementation in enhancing muscle~     mass and strength in community-dwelling older adults with osteopenia /osteoporosis.~      One hundred and forty-five individuals aged 65 years and above with documented~     osteopenia/osteoporosis were scanned for sarcopenia. The participants were randomly assigned~     to one of four groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D~     (n= 36) or Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute~     3-day/week exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day~     and the control group was provided with health education using videotaped presentations,~     physician talks on topics concerning bone and muscle health. Body composition was measured~     DEXA. Vitamin D levels were measured and PA was measured using the Baecke Physical Activity~     Questionnaire. Physical performance was assessed using upper limb grip strength, walking~     speed and knee extension strength. All data was collected at baseline and at 4 months.~   "
145224|NCT01666509|"~     Rossoseq™ is registered for the treatment of inflammatory skin conditions. Rosacea is one~     such inflammatory skin disorder that has not been studied yet for the use of Rossoseq™.~     Whilst rosacea is showing features of an inflammatory skin disorder [1], particularly stage 1~     is poorly understood and treatment options are limited and therefore this study - within the~     target indication - will contribute to the learning about rosacea.~   "
145225|NCT01666496|"~     The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy~     of an interactive video game the investigators are developing at reducing risk behaviors in~     at-risk teens.~   "
145226|NCT01666483|"~     A total of 86 patients underwent total hysterectomy. Three of them refused randomization, 34~     were randomly assigned to undergo to laparoendoscopic single-site surgery (LESS) and 34 to~     undergo micro-laparoscopy (M-LPS).Laparoscopic hysterectomy can be safely performed by M-LPS~     and LESS.~   "
145227|NCT01666470|"~     Quality of life of patients with a history of drug allergy in Thailand will be studied.~   "
145228|NCT01666457|"~     The specific aim of this pre-post trial is to compare data regarding oral feeding, length of~     stay, and growth outcomes of 100 NICU infants to these same outcomes following the~     implementation of a developmentally supportive, infant driven feeding program with the NICU~     staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding~     program on a second sample of 100 NICU infants at Children's Memorial Hospital.~      The specific research questions considered in this study are:~        1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically~          fragile infants in the NICU at discharge and at 3 months post-term?~        2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile~          infants in the NICU at discharge and at 3 months post-term?~        3. What is the impact of implementing the SOFFI on the length of stay of medically fragile~          infants in the NICU?~        4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU~          staff evaluations and communications related to managing oral feedings with medically~          fragile infants?~   "
145229|NCT01666444|"~     The purpose of this study is to compare the overall survival of patients treated with~     VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women~     with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal~     cancer.~      VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple~     components of the innate immune system and is being developed as a novel therapeutic agent~     for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports~     the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD~     resulted in a significant reduction in tumor growth compared to either agent alone and an~     increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and~     VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study~     and appears to be generally well-tolerated.~   "
145278|NCT01665807|"~     The investigators hypothesize that people working in an acute care hospital setting will be~     able to successfully self-administer the intradermal vaccine (Intanza) in less time than~     nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The~     investigators also hypothesize that people administering the intradermal vaccine for the~     second time will take less time to successfully administer than people administering it for~     the first time.~   "
145279|NCT01665794|"~     The study will investigate the effects of adding carfilzomib to the combination of~     pomalidomide and dexamethasone in sequential dose escalation cohorts in patients with~     relapsed or refractory multiple myeloma. This portion of the study is complete.~      This study will also investigate the effects of adding daratumumab to the combination of~     carfilzomib, pomalidomide and dexamethasone.~   "
145230|NCT01666431|"~     Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high~     frequency of EGF-R expression. EGFR is an important regulator of tumour progression and~     proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or~     HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition~     of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the~     investigators hypothesise that EGFR signalling pathway and its interactions play an important~     role in the SCC pathogenesis and represent a good therapeutic target from these tumours.~      Primary Objectives:~      To evaluate the tumour response macroscopically in patients with primary cutaneous SCC~     lesions and in concomitant SCC in situ (AK).~      Secondary Objectives:~        -  To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in~          patients with SCC as measured by time to first AE or SAE within the study period.~        -  To investigate the molecular tumour response of squamous cell carcinoma lesions in~          patients under lapatinib treatment using a set of variables.~        -  Trial with medicinal product~   "
145231|NCT01666418|"~     This is an open, monocentric, pilot study to determine the metabolic activity~     (glucose-uptake) in vivo during monotherapy with pazopanib in comparison to combination~     therapy with pazopanib plus paclitaxel and to investigate the transcriptional profile of~     cutaneous melanoma metastasis before and during the therapy (pazopanib vs. pazopanib plus~     paclitaxel) in subjects with unresectable Stage III or Stage IV melanoma who have not~     received prior cytotoxic chemotherapy.~      Primary Objective:~      Evaluation of metabolic activity in vivo~      Secondary Objective:~      Determination of changes in gene expression profiling Evaluation of the antitumor activity of~     the combination in terms of progression free survival (PFS). Changes in S100 and LDH during~     therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)~        -  Trial with medicinal product~   "
145232|NCT01666405|"~     The purpose of this study is to determine the effectiveness of percutaneous tibial nerve~     stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc.,~     Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).~   "
145233|NCT01666392|"~     The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation~     has an impact on inflammation and lean body mass in older adults. The investigators expect~     that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass~     compared to placebo.~   "
145234|NCT01666379|"~     The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both~     administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol~     in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.~   "
145235|NCT01666366|"~     Bilateral internal thoracic arteries (BITA) demonstrated superiority over other grafts to the~     left coronary system in terms of patency and survival benefit. Several BITA configurations~     are proposed for left-sided myocardial revascularization, but the ideal BITA assemblage is~     still unidentified.~      From 03/2003 to 08/2006, 1297 consecutive patients underwent isolated bypass surgery in our~     institution. 481 patients met the inclusion criteria for randomization and 304 (64%) were~     randomized. Patients were allocated to BITA in situ grafting (n=147) or Y configuration~     (n=152) then evaluated for clinical, functional, and angiographic outcome after 6 months, 3~     and 7 years . Patient telephone interviews were conducted every 3 months and a stress test~     performed twice yearly under the referring cardiologist's supervision. Angiographic follow-up~     was performed 6 months after surgery. The primary and secondary end points were,~     respectively, major adverse cerebro-cardiovascular events (MACCE) and the proportion of ITA~     grafts that were completely occluded at follow-up angiography.~   "
145236|NCT01666353|"~     This study aims to develop methods for quantitative imaging of solid tumors in patients who~     are receiving immunotherapies that have a delayed mechanism of action.~      PET imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and~     is able to detect melanomas and other tumors, some of which are undetectable by CT. FDG PET~     is now used commonly in detecting melanoma in humans as melanomas quite consistently have~     high glucose metabolism. PET with FDG can image the response of tumors to therapy, but has~     not been extensively evaluated in melanoma nor in immunotherapy for melanoma. PET has been~     shown to be highly predictive of outcomes of patients following radioimmunotherapy of~     lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy~     initiation.~      In order to develop PET/CT as a tool to detect early evidence of response in patients with~     solid tumors receiving immune checkpoint blockade, investigators propose to perform PET/CT~     imaging prior to therapy, again between days 21 and 28, and finally at 4 months~     post-treatment initiation. Each scan will be assessed qualitatively and quantitatively.~     Investigators will use the PERCIST criteria to determine peak and maximum standardized uptake~     values corrected for lean body mass (SUL) in tumor, tumor volumes, and tumor total glycolytic~     volumes, and will use CT from PET/CT to measure tumor size by immune RECIST criteria. (See~     section on Outcome Evaluation below.) Investigators will assess whether early changes in~     tumor metabolism seen on FDG PET are predictive of progression free and overall survival~     outcomes. Through these systematic pilot studies, investigators hope to better link FDG PET~     measurements to individual patient responses to immune checkpoint blockade therapy and better~     understand and refine this emerging and often effective therapeutic approach.~   "
145237|NCT01666340|"~     Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The~     extent of reduction will be intensity dependent.~   "
145238|NCT01666327|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel~     disease.~   "
145239|NCT01666314|"~     This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the~     pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly~     with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer~   "
145240|NCT01666301|"~     Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing~     the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration~     interval decreases hemoglobin variability. The benefit of reducing the administration~     interval was however lessened by the variability induced by more frequent dosage adjustments.~     The purpose of this study was to analyze the reticulocyte and hemoglobin kinetics under~     different ESAs and administration intervals in a collective of chronic hemodialysis patients.~      Methods: The study was designed as an open-label, randomized, four-period cross-over~     investigation, including 30 patients under chronic hemodialysis at the regional hospital of~     Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies~     (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were~     compared with each other. The mean square successive difference of hemoglobin, reticulocyte~     count and ESAs dose was used to quantify variability. We distinguished a short- and a~     long-term variability based respectively on the weekly and monthly successive difference.~   "
145241|NCT01666288|"~     Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often difficult~     to diagnose due to the wide heterogeneity of clinical manifestations. The inciting agent is~     often difficult to pinpoint and may include food, environmental allergens in patients~     undergoing allergen immunotherapy, insect stings, and medications. Evidence of allergy by~     demonstration of a positive skin test to the inciting agent, is helpful only if skin testing~     is available. The only diagnostic modality that is useful in the diagnosis of anaphylaxis~     when IgE skin testing is not available and the inciting agent is unknown, is an elevated~     serum tryptase level. However, a diagnosis of anaphylaxis can be made without a tryptase~     level or if the tryptase level is normal. A simple, non-invasive test for patients with~     anaphylaxis is not currently available and would be helpful to diagnose and to guide further~     management options.~      Patients who develop anaphylaxis to environmental allergens or venoms during routine~     outpatient subcutaneous allergen or venom immunotherapy are an ideal population to study as~     we are able to evaluate these specific reactions in a controlled, clinical environment.~     Although anaphylaxis is uncommon, the incidence has been estimated to vary between 0.01 and 4~     percent of all allergy injections. Subcutaneous allergen or venom immunotherapies are a well~     established form of therapy for patients with allergic rhinitis, allergic asthma, or a~     confirmed sensitivity to stinging insects. Serial blood sampling can be performed in this~     group of patients during a reaction and at baseline one week after a reaction, thereby~     allowing each patient to serve as his or her own biological control.~      Metabolomics is the study of metabolic pathways and the unique biochemical molecules which~     result from the regulatory response to physiological stressors, disease processes, drug~     therapy, or allergen or venom immunotherapy. By measuring changes in metabolite~     concentrations, the range of biochemical effects and therapeutic intervention can be~     determined.~      The investigator plans to use metabolic profiling of blood samples collected at the time of~     anaphylaxis and one week after, to see if a simple, non-invasive test for patients with~     anaphylaxis could be developed.~   "
145242|NCT01666275|"~     Metabolomics is the study of metabolic pathways and the unique biochemical molecules which~     result from the regulatory response to physiological stressors, disease processes, or drug~     therapy. By measuring changes in metabolite concentrations, the range of biochemical effects~     and therapeutic intervention can be determined.~      Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease~     characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to~     aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin~     during challenge/desensitization is equivalent to an allergic drug reaction however we are~     able to evaluate these specific reactions in a controlled, clinical environment. This~     population of patients undergoing aspirin desensitization is ideal for studying metabolomics~     as serial blood sampling can be performed in patients before, during a reaction, and after~     aspirin desensitization, thereby allowing each patient to serve as his or her own biological~     control. The investigator hopes that this study of metabolomics will allow for better methods~     of identifying anaphylaxis in the future.~   "
145243|NCT01666262|"~     The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live~     Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral~     immune response of the above vaccine after intranasal application by using HAI test, micro~     neutralization assays.~   "
145244|NCT01666249|"~     The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific~     antibodies against factor D and neutralizes D antigen present in the Rh-positive fetal red~     blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).~     This a immunization study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh~     and Coombs negative women with risk sensitization.~   "
145245|NCT01666236|"~     Study the effectiveness of the treatment detachment of retinal pigment epithelium secondary~     to polypoidal choroidal vasculopathy. Efficacy will be assessed by regression of polyp area~     after twelve months, compared to baseline. Treatment under study is a triple therapy with: 1)~     reduced-fluence photodynamic therapy (PDT), 2) intravitreal (IVT) triamcinolone and, 3) IVT~     ranibizumab, for the treatment of detachment of the retinal pigment epithelium (PED)~     secondary to Polypoidal Choroidal Vasculopathy (PCV).~   "
145246|NCT01666223|"~     The purpose of this study is to describe the physiological, pathophysiological and~     potentially therapeutic implications of bile-induced glucagon-like peptide-1 (GLP-1)~     secretion in human glucose homeostasis.~   "
145247|NCT01666210|"~     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)~     depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation~     and pain in subjects who have undergone cataract extraction with intra-ocular lens~     implantation.~   "
145248|NCT01666197|"~     The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet~     compared with placebo taken three times a day in subjects with acute ankle sprains under~     'in-use' conditions, in particular with regard to pain relief.~   "
145249|NCT01666184|"~     Study Design:~      Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for~     pancreatic cancer; (3) willing to sign informed consent.~      The pancreatic tumor, tissue specimen and blood sample before or after treatment will be~     collected from department of pathology, surgery or diagnostic medicine.~   "
145250|NCT01666171|"~     RATIONALE: Learning about the effect of metformin hydrochloride in breast density of women~     with early-stage breast cancer may help plan treatment.~      PURPOSE: This trial studies changes in breast density in patients with early-stage breast~     cancer treated with metformin hydrochloride or placebo on CAN-NCIC-MA.32.~   "
145251|NCT01666158|"~     Consenting patients scheduled for esophageal resection surgery will be randomized to receive~     standard nutrition counseling (including nutritional supplements as needed) or standard~     nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.~      It is hypothesized that, compared with the group receiving nutrition alone, the addition of~     physical exercise to nutrition starting before surgery and continuing for 8 weeks after~     surgery will have a significantly greater impact on functional walking capacity during the~     prehabilitation period and during the postoperative period, and on the incidence of~     postoperative pulmonary complications.~   "
145252|NCT01666145|"~     Advanced Image Guidance for this study was used during laparoscopic microwave ablation~     surgery to help the surgeon accurately place the ablation needle into the tumor of patients~     diagnosed with liver cancer.~   "
145253|NCT01666132|"~     Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients~     with chronic ischemic heart disease and LVEF < 40%. The primary objective is to determine~     whether the administration of the cells improves recovery of the left ventricular function.~     Secondary objective is the finding of clinical or paraclinical parameters to predict~     potential benefits of the treatment (basing on MRI characteristics such as size,~     transmurality of the myocardial infarction and peri-lesional ischemia).~      In the first part of the study 10 patients are treated without control group. This phase~     serves as feasibility and safety part of the study.~   "
145321|NCT01665235|"~     Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with~     intracranial artery stenosis~   "
145256|NCT01666093|"~     Background: Lower limb arterial revascularization procedures, either percutaneously or~     surgically performed, are an established treatment modality of ischemic foot ulcers,~     especially in the setting of a critical limb ischemia. Many other lower limb ulcers are~     secondary to a combined disease, which may include a concomitant venous disease (chronic~     venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel~     disease). In this setting, and especially in the absence of a concomitant severe~     macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb~     revascularization have so far never been evaluated in a prospective study.~      Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular~     revascularization approach of the lower limb, in all consecutive patients presenting with a~     non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e.~     mixed-origin ulcers).~      Material and methods: This prospective study will consecutively include all patients~     presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer~     co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous~     disease, infectious disease or inflammatory disorder must be previously evaluated and~     adequately treated (i.e. compression stocking, varices stripping, antibiotics, local ±~     systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be~     obtained in all patients. The arterial screening must included an ankle-brachial index (ABI)~     and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot~     and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This~     arterial work-up must be compatible with the presence of a mild to moderate peripheral artery~     disease without any sign or criteria suggesting the presence of a critical limb ischemia.~      End-points: The success rate of perform an endovascular revascularization intervention in all~     consecutive patients which qualify according to the inclusion criteria (technical~     feasibility). Establish the proportion of procedural related complications (safety). Analyze~     the clinical and the para-clinical improvements in term of heal of the ulcers, as well as the~     improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure (efficacy).~      Sample size: The investigators plan to include ≈ 30 patients in two years. After 1 year of~     enrollment the investigators will perform an interim analysis and will decide at that moment,~     according to the observed end-points, if prolonging the study would be of any scientific~     value or if the study has to be interrupt earlier because of a significant improvement of all~     already treated ulcers.~   "
145257|NCT01666080|"~     This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell~     transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant~     or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total~     body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve~     an acceptable level of donor-derived engraftment following a previous allogeneic HCT.~   "
145258|NCT01666067|"~     The investigators hypothesize that vytorin will improve insulin resistance compared with~     simvastatin~   "
145259|NCT01666054|"~     The study hypothesis is that reducing patient-ventilator asynchrony will reduce time required~     to wean from mechanical ventilation. The purpose of this pilot study is (1) to assess study~     feasibility in terms of recruitment, protocol adherence and efficacy of the intervention for~     reducing asynchrony, (2) to assess baseline rates of asynchrony and outcomes in the control~     arm in order to perform sample size calculations, if needed, for further, larger studies~     designed to detect differences in weaning time in specific, predefined populations and (3) to~     examine how often ineffective triggering (and therefore reduced ventilator respiratory rate)~     at higher levels of pressure support lead to a false conclusion that higher levels of support~     are needed to diminish respiratory distress.~   "
145260|NCT01666041|"~     The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared~     with fenofibrate~   "
145261|NCT01666028|"~     The main objective of this study is to determine the feasibility, efficacy and safety of~     automated closed-loop glucose control in the home setting over a short term period. The data~     and experienced gained from this study will be utilised in planning future home studies.~      This is an open-label, three centre, randomised, crossover design, involving two, 8 day~     (first day in the clinical research facility and seven days at home) study periods during~     which glucose levels will be controlled either by an automated closed-loop system or by~     subjects usual insulin pump therapy in random order. A total of up to 24 adults (aiming for~     18 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be~     recruited through diabetes clinics and other established methods in participating centres.~      Subjects will receive appropriate training in the safe use of closed-loop insulin delivery~     system. During the 24 hour in-patient stay subjects will be encouraged to mimic their usual~     day and will be allowed to walk inside hospital premises. Subjects will be advised to~     discontinue automated closed-loop insulin delivery and follow their usual insulin pump~     therapy for periods of strenuous exercise during the 7 day home study phase.~      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by~     CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the~     time spent with glucose levels above and below target, as recorded by CGM, and other~     CGM-based metrics, and for the stay at the clinical research facility, time spent in the~     target range, above and below the target range as measured by plasma glucose.~   "
145262|NCT01666015|"~     Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship~     and cure various oncologic diseases. However, this therapy is associated with high mortality~     rates and numerous negative side-effects. The recovery of the immune system is a special~     concern and plays a key role in the success of this treatment. In healthy populations it is~     known that exercise plays an important role in immune system regulation, but little is known~     about the role of exercise in the hematological and immunological recovery of children~     undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized~     Controlled Trial is: study the effect of an exercise program on immune cell recovery in~     patients undergoing autologous stem cell transplantation. The Secondary objective is to~     determine if an exercise intervention might diminish the deterioration of quality of life,~     physical fitness, and the acquisition of a sedentary lifestyle.~      Methods~      Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to~     18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or~     control group. The exercise group will participate in a two-phase exercise intervention (in~     and outpatient) from hospitalization until 10 weeks after discharge. The exercise program~     includes strength, flexibility and aerobic exercise. During the inpatient phase this program~     will be performed 5 times/week and will be supervised. The outpatient phase will combine a~     supervised session with two home-based exercise sessions with the use of the Wii device. The~     control group will follow the standard protocol without any specific exercise program. A~     range of outcomes, including quantitative and functional recovery of immune system, cytokine~     levels in serum, NK cells and their subset recovery and function, and gene expression of~     activating and inhibitory NK cell receptors, body composition, nutrition, quality of life,~     fatigue, health-related fitness assessment and physical activity levels will be examined,~     providing the most comprehensive assessment to date.~      Discussion We expect to find an improvement in the immunological recovery, quality of life,~     decreased acquisition of sedentary behavior and less fitness deconditioning.~   "
145263|NCT01666002|"~     The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond~     pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will~     compare the success rates of those receiving laser treatments with untreated patients. This~     study will provide a clinical basis for determining the relative effectiveness of an~     increasingly utilized treatment method.~   "
145322|NCT01665222|"~     The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide~     from 2 tablet products and determine if the 2 products were bioequivalent to each other.~   "
145323|NCT01665209|"~     The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide~     from 2 tablet products and determine if the 2 products were bioequivalent to each other.~   "
145264|NCT01665989|"~     This research project has two primary specific aims in the Partners HealthCare clinical~     population and setting:~        1. To compare the effects of two interventions, a translation of the Look AHEAD lifestyle~          behavioral intervention program with usual care (UC) (brief nutrition counseling and~          referral to Nutrition Services, the current standard), on the primary outcome of weight~          loss and secondary outcomes of HbA1c, blood pressure, fasting lipid levels, and~          prescription medication (doses and costs) for diabetes and its related conditions.~           We hypothesize that participants who receive the translation of the Look AHEAD program~          will lose significantly more weight and have lower glycemia, blood pressure,~          cholesterol, and drug doses and costs for these conditions than participants who receive~          UC.~        2. To compare the effects of the two interventions on health behaviors, self-efficacy,~          diabetes-specific quality-of-life and patient satisfaction with quality of care.~      We hypothesize that participants who receive the translation of the Look AHEAD program will~     be more satisfied with their care and will experience greater improvements in health~     behavior, self-efficacy, and diabetes-specific quality-of-life compared to participants who~     receive UC.~      Secondary specific aim: To assess the cost-effectiveness of the two interventions and the~     potential cost savings in terms of reductions in medication doses. In the current~     environment, a cost effective approach to lifestyle change is imperative. The costs and~     benefits of the interventions in this project will be carefully analyzed.~   "
145265|NCT01665976|"~     This single center, randomized, single dose, open-label, four period cross-over study will~     evaluate the relative bioavailability of RO4917838 and the effect of food following oral~     administration in healthy volunteers. Subjects will receive in randomized order single oral~     doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838~     hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days~     between treatments. Anticipated time on study will be up to 23 weeks.~   "
145266|NCT01665963|"~     Patients receiving oral anticoagulation or anti-platelet therapy are at high risk of hematoma~     after device implantation. This study intends to examine the efficacy of the TopClosure(c)~     System in wound healing in these patients.~   "
145267|NCT01665950|"~     Primary Aim: To estimate the antidepressant efficacy of simvastatin versus placebo as an~     adjunct to lithium, valproate, and/or other atypical antipsychotic therapy among individuals~     with bipolar I disorder in a nonpsychotic major depressive episode.~      Hypothesis: Simvastatin will be superior to placebo in improvement of depressive symptoms~     assessed by the Montgomery-Asberg Depression Rating Scale (MADRS).~   "
145268|NCT01665937|"~     STA-9090 works by inhibiting the function of a protein in tumor cells called Hsp90. Hsp90 is~     thought to play a role in tumor growth. By interfering with this protein's function, STA-9090~     may help kill tumor cells. This drug has been used in other research studies and information~     from those studies suggests that this agent may help to slow tumor growth in HCC.~      The purpose of this research study is to find the highest dose of STA-9090 that can safely be~     given to participants with advanced HCC. The investigators will also get more information~     about the safety of STA-9090 and perform tests to learn more about how STA-9090 affects the~     body.~   "
145269|NCT01665924|"~     The purpose of the study is to evaluate the amount of compound present in the blood~     (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy~     subjects.~      During the course of the study, the effect of aging on the pharmacokinetics as well as the~     effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics)~     will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy~     subjects will be characterized.~   "
145270|NCT01665911|"~     The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind~     and will utilize a 5-way cross-over study design with a primary objective to determine if a~     higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary~     objectives are to determine in a higher concentration of fluoride in milk will provide a~     greater caries preventive effect and if the caries preventive effect of fluoridated milk~     follows a dose-response pattern.~   "
145271|NCT01665898|"~     Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon~     polyps.~   "
145272|NCT01665885|"~     HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy,~     tolerability, practicability and safety of endovascular versus surface cooling in awake~     stroke patients.~   "
145273|NCT01665872|"~     Phase II of the MOMS Partnership aims to:~        1. conduct a needs assessment of the mental health of mothers residing in New Haven, CT;~        2. provide on-site group intervention services (randomized by housing community) to improve~          signs/symptoms of depression/stress/trauma among mothers living onsite.~   "
145274|NCT01665859|"~     Umbilical and epigastric hernia repairs are common and performed by numerous surgical~     techniques. Considering that the hernia repairs in general are relatively small and simple~     procedures there are disproportionate poor results.~      The aim of present study is to determine surgical risk factors for readmission after~     umbilical and epigastric hernia repair and to report risk factors for later reoperation for~     recurrence.~   "
145275|NCT01665846|"~     The purpose of this study is to describe the radiologic findings on brain MRI after~     ferumoxytol administration in HIV-infected patients with cognitive impairment.~   "
145276|NCT01665833|"~     We hypothesize that Coronary Artery Disease (CAD) severity assessed by SYNTAX score is an~     independent predictor of recurrent or persistent angina following coronary revascularization.~     The SYNTAX score is a score that suggests the severity of coronary artery disease detected by~     coronary angiography. Coronary revascularization is a procedure that occurs in two ways, a~     percutaneous coronary intervention (PCI) and a coronary artery bypass graft (CABG) and is~     done when there is narrowing and blockage or hardening of the arteries (atherosclerosis)~     surrounding the heart. Narrowing and blockages reduce blood flow to parts of the heart~     causing chest pain (known as angina) and sometimes myocardial infarction.~   "
145277|NCT01665820|"~     Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more~     effective in identifying referrable murmurs than using a traditional stethoscope.~   "
145324|NCT01665196|"~     This is an open-label study to investigate the diagnostic performance of 18F-FDG PET/CT~     (positron emission tomography/computed tomography) in evaluation of patients with~     IgG4-related disease. A single dose of 18F-FDG will be intravenously injected into patients~     with IgG4-related disease before and after treatment.~   "
145280|NCT01665781|"~     Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore~     subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence~     of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m~     plus the presence of one or more of the following: gastrointestinal symptoms (anorexia,~     nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass~     is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO)~     secretion begins hours after ascent and stimulates bone marrow production of red blood cells,~     but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that~     EPO therapy weeks before altitude exposure decrease high altitude illness.~      In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM)~     reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal~     oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the~     basis of this report, USARIEM did not recommend use of recombinant EPO for altitude~     acclimatization.~      However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO~     therapy have been shown to decrease fatigue and increase work capacity and exercise~     tolerance. In addition, improvement in CNS function and cognitive ability has been noted with~     EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold;~     decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are~     symptoms associated with high altitude illness.~      The investigators also reported improved muscle energy metabolism with EPO in dialysis~     patients, but not with RBC transfusion.~      In this study, the investigators will conduct a randomised controlled trial to assess the~     effect of EPO administration on AMS at an altitude of 4,130 m.~   "
145281|NCT01665768|"~     This research is being done to determine if combining an investigational drug called~     Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose~     chemotherapy.~   "
145282|NCT01665755|"~     In this study, we are comparing the difference in outcomes between patients who were given~     shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before~     CPR is started. The study population will be all cardiac arrest patients attended by the~     staff of the Emergency Department who fulfil the eligibility criteria. Patients will be~     managed according to currently approved cardiac arrest protocols. Patients confirmed in~     cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest~     compressions are delivered by an automated device) is prepared. Mechanical CPR should be~     started as soon as possible (<1 minute). If patients are eligible to be shocked, they will~     receive shocks either during upstroke of CPR or before CPR is started.~      Thus the purpose of this study is to answer the question whether are there improvement in~     survival between when shocks are given during upstroke and before CPR is started.~   "
145283|NCT01665742|"~     The number of overweight and obese children has increased in Ireland at a greater rate than~     worldwide trends. The poor eating patterns that drive adolescent obesity leads to an increase~     in the number of unhealthy inflammatory hormones and fats circulating in the blood which~     increase an adolescent's risk of developing diabetes and heart disease later in life. Dietary~     patterns have changed whereby key nutrients that are found in fruit, vegetables and fish,~     which are known to have beneficial effects and reduce risk of obesity and diabetes in later~     life, may need to be replaced. This project will determine whether a key anti-inflammatory~     nutrient supplement taken for 8 weeks will improve the metabolic profile of adolescents aged~     13-18 years old. Detailed cellular analysis will determine the cellular and molecular~     mechanisms to provide a thorough explanation of the health effects of this intervention.~   "
145284|NCT01665729|"~     Negligence or contempt of the etiology and pathogenesis of minor ischaemic stroke in the~     early diagnosis and effective treatment leads to more than 40-50% of patient with recurrent~     episodes, and 10% patient died. Therefore, diagnosis and treatment of minor ischaemic stroke~     according to the etiology and pathogenesis is important.~      The 2007 Korean modified TOAST type got some progress, but there exists two major~     disadvantages: imperfect diagnosis and pathogenesis of perforator artery infarction etiology;~     lack of typing according to the pathogenesis of large atherosclerotic infarction and taking~     measures of treatment according to the new types. Recently, domestic professor Gaoshan~     proposes new approach to diagnose and treat minor ischaemic stroke according to the etiology~     and pathogenesis of CISS typing, but the pathogenesis of hypoperfusion infarction with severe~     stenosis of large artery is unclear. Is it low perfusion? Or artery-artery embolization? Or~     both? How to distinguish the pathogenesis of branch artery disease: by atherosclerosis? Or~     hyalinosis? Or both? How to check the validity of clinical types? This study take different~     interventions according to different types and observation of the long term clinical results~     of intervention( mortality, recurrence rate, disability rate and rate of cerebral hemorrhage~     and subarachnoid hemorrhage), in order to clarify the new types can indeed solve the current~     problem of minor ischaemic stroke with high mortality, recurrence rate, disability rate and~     rate of cerebral hemorrhage and subarachnoid hemorrhage.~   "
145285|NCT01665716|"~     In healthy women, early menopause is an event that is associated with the exacerbation of~     several risk factors of cardiovascular and skeletal disease. The occurrence of an early~     menopause may have even greater impact in women with type 1 diabetes mellitus (DM-1). A small~     number of studies has demonstrated that DM-1 patients experience cycle irregularity and~     menopause at a younger age compared to controls. In addition, initial studies have suggested~     that also in regular cycling DM-1 women a decreased ovarian reserve status for age is~     present. The explanation for this early decay in ovarian reserve in DM-1 patients remains~     unknown. Next to auto immunity, vascular factors may be possible contributors to accelerated~     ovarian ageing in DM-1 patients.~      Confirmation of more accelerated ovarian ageing in DM-1 women is urgently needed in view of~     the added risk factors outlined above. Also, the mechanisms behind the advanced ovarian~     ageing, with focus on vascular factors, may shed new light on our understanding of the~     ovarian ageing process per se.~   "
145286|NCT01665703|"~     This pilot study is designed to evaluate imaging parameters indicative of underlying tumor~     biology. Patients with large renal masses (>3 cm, or at the discretion of the investigator)~     who are planning to undergo nephrectomy will be identified, and recruited to undergo a~     contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography~     (MR-FDG-PET) scan.~   "
145325|NCT01665183|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has~     been used to treat patients that have cancers that require arginine. In this study, ADI will~     be combined with the well known chemotherapy cisplatin, and the safety and potential efficacy~     of this combination will be explored in patients with cancers that require arginine.~   "
145326|NCT01665170|"~     A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora~     incarnata L. in an acute stressful situation~   "
145287|NCT01665690|"~     The Washington State Community Expedited Partner Therapy Trial is a stepped-wedge community~     level randomized trial designed to test the hypothesis that a public health program designed~     to increase the use of expedited partner therapy can decrease the prevalence of chlamydial~     infection in young women and the incidence of gonorrhea in Washington state. The study~     intervention will be modeled after and intervention previously evaluated in King County WA~     (Golden MR, Sex Transm Dis 2007;598-603). The intervention has two components: 1) promotion~     of patient delivered partner therapy (PDPT) use by medical providers in accordance with~     Washington state guidelines; and 2) targeted provision of partner services. PDPT use will be~     promoted through education and by making medication packs for PDPT available statewide.~     Medical providers will refer selected persons with gonorrhea or chlamydial infection for~     partner services based on defined criteria associated with failure to ensure partners'~     treatment. The intervention will be instituted in four waves separated by 6-9 months. Each~     wave will include approximately 6 local health jurisdictions. The order in which health~     jurisdictions initiate the intervention will be randomly assigned. The study's primary~     endpoint will be the prevalence of chlamydial infection in women age 15-25 tested through~     clinics participating in the state's Infertility Prevention Project (IPP) and the incidence~     of gonorrhea among women as determined through public health reporting.~   "
145288|NCT01665677|"~     Hematopoietic stem cell transplantation is a procedure in which a person receives blood~     forming stem cells from a person called a donor. The stem cells can be obtained from the~     hollow part of the hip bone or from blood.~      A serious problem with this treatment is graft-versus-host disease (GVHD). This happens when~     stem cells from the donor attack normal cells of the recipient. Currently, there is no~     universal standard of care in the United States to prevent GVHD.~      This study is being done to see if a medicine that is used to lower cholesterol can also help~     in reducing GVHD.~      Patients will receive atorvastatin daily by mouth starting 14 days before stem cell~     transplant. They will continue to take atorvastatin until 180 days after transplant. This~     medicine may be stopped earlier if there is a bad side effect or a severe GVHD. Patients will~     also receive standard treatment to prevent GVHD. Patients will undergo many tests that are~     standard for their treatment at West Virginia University (WVU), including blood tests to~     check blood counts, kidney function and HIV status; blood test to check for pregnancy; Multi~     Gated Acquisition Scan (MUGA scan)or echocardiogram to test heart function; lung function~     testing; and bone marrow aspirate or biopsy. Patients will also have the option to provide~     blood samples for optional research related to the study.~   "
145289|NCT01665664|"~     Underfeeding in the critically ill patient is a common observable fact throughout intensive~     care units. Patients who develop caloric deficit during their stay in the ICU have been shown~     in previous reports to be associated with increased complications such as increased rate of~     infections, and nosocomial blood stream infections. Yet, other studies have shown that~     patients with moderate caloric deficit may be associated with better outcome than patients~     who receive higher levels of caloric intake.~   "
145290|NCT01665651|"~     Patients with serious chronic renal insufficiency usually develop secondary osteoporosis or~     bone loss, especially those with chronic dialysis, and the degree of bone loss is corrected~     with decrease of renal function. In traditional Chinese medicine, kidney function is~     considered to dominate bone development and metabolism. Kidney Yin and Yang replenishment~     will help improve bone development and metabolism.~   "
145291|NCT01665638|"~     The purpose of this study is to assess whether treatment with a single oral 300 mg dose of~     canagliflozin alters the kinetics (ie, clearance/removal from body) of serum C-peptide (a~     protein released from the pancreas during insulin secretion) in healthy adult volunteers.~   "
145292|NCT01665625|"~     Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic~     cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic~     cancer for over two decades and combinations of gemcitabine with different chemotherapeutic~     drugs have been investigated to improve the outcomes of pancreatic cancer. However, no~     substantial improvement in patient survival has been achieved. Locoregional chemotherapy via~     intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug~     concentrations and reducing systemic toxicities. In this study, the investigators hypothesis~     that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy.~     The investigators will analyze and evaluate the effect and safety of an implanted~     percutaneous left subclavian artery port-catheter drug delivery system for regional~     chemotherapy of inoperable pancreatic carcinoma.~   "
145293|NCT01665612|"~     The purpose of the clinical investigation is to assess the clinical and subjective~     performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two~     silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).~   "
145294|NCT01665599|"~     This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone~     concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy~     of testosterone gel (2%) delivered using an applicator.~   "
145303|NCT01665482|"~     Rationale: It is well established that increased intake of saturated fatty acids (SFA) is~     associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by~     dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to~     clarify the association between dietary fatty acids and metabolic risk markers beyond lipid~     profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy~     replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited~     evidence is available on the effects of dietary fatty acids on insulin sensitivity and~     secretion. The current study is designed to investigate the effects of SFA versus MUFA versus~     CARB on insulinemic response and lipid metabolism in healthy individuals with central~     obesity.~      Study design: A randomized, crossover, single blind design study was carried out. The~     subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day~     during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein~     content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy~     intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based~     on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total~     energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000~     kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the~     exchange from oleic acid (C18:1).~      Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence~     insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid~     metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be~     comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin~     sensitivity, endothelial and vascular function and inflammation~   "
145304|NCT01665469|"~     The hypothesis of the study is that tomato extracted lycopene will be able to decrease~     postprandial oxidation and inﬂammation in healthy weight men and women when compared to~     Placebo.~   "
145295|NCT01665586|"~     Recently many studies reported that intraoperative dexmedetomidine administration undergoing~     spinal anesthesia give a satisfactory sedation in elderly patients and cause less respiratory~     depressions compared other sedatives(e.g. benzodiazepine) But the optimal dose of~     dexmedetomidine for sedative effect in elderly patients undergoing spinal anesthesia was not~     got general consensus.~      The investigators hypothesized that the dose requirements would be lower than in elderly~     patients than young patients. Furthermore, intrathecal small dose opioids enhance the~     analgesia provided by bupivacaine due to synergistic effects and it would reduce the dose of~     dexmedetomidine.~      The purpose of this study was to determine the dose of dexmedetomidine to provide~     satisfactory sedation undergoing spinal anesthesia with or without additive small dose~     intrathecal opioids.~      Elderly patients(65~85 years old) undergoing TURP or TURB were enrolled in this~     single-blinded study. Forty patients were randomly assigned to receive intrathecal hyperbaric~     bupivacaine 6mg coadministered with 20mcg fentanyl or placebo normal saline 0.4cc. After the~     induction (bilateral T10 sensory level to pinprick within 5 mins of intrathecal drug~     administration), continuous intravenous dexmedetomidine was started in dose of 0.8, 0.6, 0.5,~     0.4, 0.3, or 0.2mcg. Successful sedation was defined as OASS score 3 or 4 within 20 minutes~     of dexmedetomidine infusion. The dose of dexmedetomidine was selected for each patient~     according to an up and down method. Intraoperative arterial pressure, heart rate, and~     bispectral index was compared. Postoperative pain score, the time for the regression of~     sensory and motor was recorded for further analysis.~   "
145296|NCT01665573|"~     The purpose of this double blind, randomized, controlled, proof-of-concept study is to test~     the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On~     three days over not more than two weeks, subjects will be trained to associate cues with two~     different stimuli, then this association will be extinguished. Cannabinoid receptor~     stimulation will be accomplished indirectly by harnessing the brain's capacity to~     endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents~     degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845.~     Some details of this study have not been disclosed to preserve the study design.~   "
145297|NCT01665560|"~     The overarching goal of this project is to understand how nicotine addiction interacts with~     feeding behaviors and brain representation of food reward. The current proposal is part of a~     larger effort to begin a program of research to elucidate similarities and differences in~     perception of, and behavioral and neural response to, food and cigarette aromas as a function~     of 1) smoking status (smokers, ex-smokers who do gain weight, ex-smokers who do not gain~     weight, non-smokers), 2) internal state (hungry, full), and 3) cigarette deprivation (acute,~     chronic). A general hypothesis is that there are overlapping neural mechanisms governing food~     reward and cigarette reward in smokers and that this overlap includes incentive salience~     encoding.~   "
145298|NCT01665547|"~     Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation~     induction in women with clomiphene resistant PCOS~   "
145299|NCT01665534|"~     Salt is a main environmental risk factor involved in atherosclerotic complications and in the~     high risk of a variety of cardiovascular (CV) diseases including hypertension, left~     ventricular hypertrophy (LVH), chronic kidney disease (CKD) and heart failure. The link~     between sodium and cardiovascular disease is complex and involves blood pressure (BP)~     dependent and independent mechanisms. Among the latter, inflammation is suspected to be a~     major effector of arterial damage brought about by the salt excess in animal models. In~     humans, C-Reactive Protein (CRP) associated directly with dietary salt intake in a~     population-based survey but such a link was not confirmed in other studies. This apparent~     discrepancy may depend on the observational (i.e., open to confounding) nature of these~     studies. Inflammatory cytokines are essential for the short term systemic response to~     environmental stressors. For example it is well established that TNF-α, a cytokine that~     modulates renin gene expression by signalling via TNF-receptor 2, exerts a protective effect~     for the myocardium in a stressful condition like experimental cardiac ischemia while low~     levels of adiponectin have a detrimental effect in the same setting. Thus, the~     inflammation-sodium relationship may be non-linear and severe salt restriction may actually~     trigger inflammation, a hypothesis suggested by the observation that biomarkers of~     inflammation rose in response to salt depletion in a sequential study in essential~     hypertensives. However, the lack of randomization in this study leaves open the question~     whether the observed pro-inflammatory effect was due to change in salt intake or to other,~     unmeasured time-dependent effect(s). With this background in mind the investigators setup a~     randomized, single masked, cross-over study to assess the effect of a short term very low~     salt diet on biomarkers of innate immunity in patients with uncomplicated essential~     hypertension.~   "
145300|NCT01665521|"~     Our research will examine a chest pain care strategy, called the HEART pathway, which is~     designed to correctly identify Emergency Department patients at high-risk for cardiovascular~     events, likely to benefit from further testing, and patients at very-low-risk for~     cardiovascular events, who may be safely discharged home. By using an individual's risk~     assessment to determining testing, we hope to improve the quality and efficiency of the care~     delivered to Emergency Department patients with chest pain. Our study will determine if the~     HEART pathway, which combines a clinical decision rule, the HEART score, and two serial~     troponin measurements, will reduce stress testing and cardiovascular imaging, decrease~     hospital length of stay, and reduce cost compared to usual care, while maintaining safety.~   "
145301|NCT01665508|"~     Women have less significant blockages of coronary arteries, however have greater symptoms and~     worse outcomes compared to their age-matched male counterparts. This paradox has led to the~     recognition and importance of the microvasculature ( small vessels) as a contributor to~     symptoms and outcomes. Nebivolol has unique antioxidant properties and dilates blood vessels~     and it is therefore proposed that treatment with nebivolol will reduce angina (chest~     symptoms) in women with microvascular disease as well as improve exercise capacity, reduce~     resource utilization and improve other measures of artery function.~   "
145302|NCT01665495|"~     The DROP study is a prospective, multi center, randomized, open-label trial to test the~     efficacy and safety of extended catheter pericardial drainage in patients with non-malignant~     pericardial effusions.~   "
145316|NCT01665300|"~     Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type~     2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment~     has been mandated to detect myocardial dysfunction because of the risk of heart failure with~     this treatment. Myocardial deformation imaging is a sensitive means of detecting LV~     dysfunction, but this technique has not been evaluated in patients treated with trastuzumab.~     The aim of this study was to investigate whether changes in tissue deformation, assessed by~     myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than~     conventional echocardiographic measures in patients treated with trastuzumab.~   "
145305|NCT01665456|"~     Kenya is one of the countries in sub-Saharan Africa that still experience high maternal~     mortality. For instance, in 2008/09 maternal mortality ratio was estimated to be 488/100,000~     live births. Direct obstetric complications such as puerperal sepsis, postpartum hemorrhage,~     pre-eclampsia and eclampsia, obstructed labor and indirect causes including HIV, malaria and~     anemia in pregnancy are responsible for the majority of these cases. Just under 44% of births~     in Kenya are delivered under the supervision of a skilled birth attendant.~      The overall objective of this study is to determine the effect of provider type in the~     occurrence and management of serious childbirth related complications among postpartum women~     at the community level in Bungoma and Lugari Districts of Western Province, Kenya.~      The proposed study will employ a case control study design in which women with obstetric~     complication(s)will be cases and women without obstetric complications will be controls.~     Controls will be sampled concurrently with the cases. Each time a new case is diagnosed, a~     control is selected from the population at risk in the neighborhood at that point in time.~      The study population will consist of women aged 15-49 years with a delivery in the past 12~     months. A woman who reports having experienced a birth-related complication will be recruited~     as a case while woman who reports having experienced no complication during child-birth will~     be recruited as a control.~   "
145306|NCT01665430|"~     This multicenter, open-label, single arm long-term extension of study WA19926 will evaluate~     the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with early,~     moderate to severe rheumatoid arthritis who have completed the WA19926 core study. Eligible~     participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104~     weeks.~   "
145307|NCT01665417|"~     This study is designed to compare the efficacy and safety of first-line icotinib treatment~     and first-line chemotherapy followed by maintenance treatment with icotinib.~   "
145308|NCT01665404|"~     This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on~     the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a~     single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a~     cross-over design. The anticipated time on study treatment is 40 days.~   "
145309|NCT01665391|"~     The primary objectives of this trial are as follows:~        -  to compare the achievement of a partial remission (PR) or complete remission (CR) in~          urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab~          versus placebo~        -  to compare the safety profile of patients treated with fresolimumab versus placebo~      The secondary objectives are as follows:~        -  To compare the reduction in proteinuria in patients treated with fresolimumab versus~          placebo~        -  To evaluate fresolimumab dose-dependent reduction in proteinuria~        -  To compare the change in renal function (estimated glomerular filtration rate [eGFR]) in~          patients treated with fresolimumab versus placebo~        -  To evaluate the multiple-dose pharmacokinetics of fresolimumab~   "
145310|NCT01665378|"~     Low birth weight and anemia remain intractable problems in many developing countries despite~     considerable efforts to address them. Intervening with just prenatal iron-folate (IFA)~     supplements may not be the best approach given the substantial demands for iron by maternal~     and fetal tissues. Therefore, there is an urgent need to evaluate the additional contribution~     of prepregnancy interventions. We propose a double blind randomized controlled trial in rural~     Vietnam to evaluate the efficacy of weekly pre- pregnancy IFA or Multiple Micronutrient (MM)~     supplements on birth outcomes and maternal and infant iron status compared to providing only~     prenatal IFA supplements. This project is a collaborative effort between Emory University,~     USA and Thainguyen University of Medicine and Pharmacy, Vietnam. Eligible and willing women~     of reproductive age (WRA) will be assigned randomly to one of the following 3 groups of~     pre-pregnancy weekly supplementation: 1) FA (control) 2) IFA and 3) MM. All women will~     receive daily IFA when pregnant. We will recruit ~ 5000 WRA to obtain a sample of at least~     1650 mother-infant pairs, which, at 90% power, will allow us to detect differences of ~ 60 g~     in birth weight between any two groups. Data on obstetric history, socio-demographic status,~     iron status, anthropometry and dietary intakes will be obtained at baseline. Key outcome~     measures will be 1) offspring's size and gestational age at birth 2) offspring's iron status~     at birth and 3 months of age and 3) maternal iron status at the beginning of pregnancy, 1 and~     3 months post-partum. Intention to treat approach will be used to compare the various~     intervention groups. This study is timely and responds to the WHO Global Expert Consultation~     (2007) which identified the need to evaluate the long term benefits of weekly IFA and MM~     supplementation in WRA. The findings will provide the necessary evidence to policy makers to~     recommend weekly MM or IFA supplements to WRA to improve birth outcomes. The central~     hypothesis is that pre-pregnancy weekly IFA or MM supplementation followed by prenatal IFA~     and MM supplementation respectively, will improve birth outcomes as well as maternal and~     infant iron status compared to current practice of providing only prenatal IFA supplements.~     This hypothesis will be tested by conducting a randomized double-blinded placebo-controlled~     trial in Vietnam.~   "
145311|NCT01665365|"~     The aim of this prospective follow-up study is to investigate 5-year clinical outcome in~     patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning~     before primary percutaneous coronary intervention.~   "
145312|NCT01665352|"~     The purpose of this study is to compare the safety and effect of TTP054 versus placebo on~     glucose control in patients with type 2 diabetes.~   "
145313|NCT01665339|"~     Investigators presumed that preload consumers will have more weight reduction and lower risk~     of cardiovascular disease~   "
145314|NCT01665326|"~     This is a longitudinal natural history study of Infantile Pompe disease. The investigators~     will regularly collect and review medical information for up to 10 years regarding the~     diagnosis of Pompe disease, response to enzyme replacement (ERT) using alglucosidase alfa~     (Myozyme) and response to immunosuppressive therapy in cases at risk for developing or those~     who have developed high and sustained antibodies to ERT. A subset of de-identified~     information about the natural history of Pompe disease and the response to treatment will be~     incorporated into the Lysosomal Disease Network (LDN) disease registry. The LDN is a~     nonprofit organization of scientists located around the world whose research focuses on~     Lysosomal disease.~      The specific aims of this study are:~        1. To determine and correlate Cross-Reactive Immunological Material (CRIM) status with the~          GAA gene mutations found on these patients~        2. To validate an approach for determining CRIM status from whole blood sample, with the~          gold standard determination of CRIM status by skin fibroblasts and mutation analysis~        3. To explore the clinical treatment response and natural history of CRIM-positive and~          CRIM-negative Pompe disease patients with and without immune modulation~        4. To investigate the role of immune response to treatment~   "
145315|NCT01665313|"~     The attention and clinical performance of physician might be decreased after outpatient~     clinic session compared to those measured before outpatient clinic.~   "
145327|NCT01665157|"~     The purpose of this study is to evaluate the efficacy and the acceptability of low-residue~     diet package (Enimaclin®) as diet control before colonoscopy.~   "
145329|NCT01665131|"~     Implantable cardiac defibrillators (ICDs) are devices that are put into patients at high risk~     of sudden cardiac death. They are used to treat life threatening heart rhythm disorders. They~     have conventionally consisted of a generator sitting under the skin of the chest and leads~     which pass from veins in the collar bone region to the heart. Problems with these devices can~     necessitate extraction, with the commonest reason being infection. If extraction is required~     for infection then re-implantation is usually deferred for approximately one week whilst~     antibiotics are given so that the risk of infection of the new device can be minimised. This~     has considerable implications for healthcare resources. A new ICD has been developed that is~     entirely subcutaneous with no intravenous element. It is already in clinical use and is~     positioned remote from conventional ICD sites. With no intravenous element there is very~     little risk of infection in the blood affecting the new device. It is therefore likely to be~     possible to re-implant these devices immediately after extracting a conventional system. The~     aim of this research is to assess the outcome in patients re-implanted with this device~     immediately after conventional ICD system extraction. This data will be compared compared to~     those who have conventional systems re-implanted after the necessary delay.~   "
145330|NCT01665118|"~     The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio~     Frequency) device in the reduction of thigh circumference.~   "
145331|NCT01665105|"~     The purpose of this present study was to investigate the effect of electroacupuncture at both~     Zusanli and at both Yanglingquan acupoints on autonomic nerve modulating cardiovascular~     activity, and skin blood flow and skin temperature. The investigators use pulse rate~     variability to investigate autonomic nerve modulates cardiovascular function, and using~     distant skin blood flow and skin temperature recordings to investigate the relationship~     between the same names meridian of hand and foot.~   "
145332|NCT01665092|"~     Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate~     oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling~     and cardiac mechanical efficiency. The overall goal of this proposal is to investigate~     L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators~     will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor~     dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an~     associated decrease in 28-day mortality suggesting the need for further phase III study. To~     accomplish this the investigators will conduct a phase II, double blinded, placebo~     controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent~     septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or~     high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early~     resuscitative care.~   "
145333|NCT01665079|"~     The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of~     a single bolus dose of propofol in obese patients and to extract a time to peak effect~     (t-peak) from the estimated model parameters.~   "
145334|NCT01665066|"~     The aim of the present study is to compare serum nicotine levels of different e-Cigarette~     strength with usual cigarettes. Serum levels of carcinogenic and toxic substances will be~     also compared.~   "
145335|NCT01665053|"~     The purpose of this study is to assess the safety and effectiveness of the SYNERGY~     Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with~     atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries~     ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).~   "
145336|NCT01665040|"~     The primary objective of this study is to investigate patient satisfaction with treatment~     using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.~   "
145337|NCT01665027|"~     The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to~     2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction~     in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of~     delivery by vacuum in C/S with normal caesarean section.~   "
145338|NCT01665014|"~     The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole~     preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT)~     followed by high-dose melphalan used prior to second autoHSCT is safe and effective in~     patients with multiple myeloma (MM).~   "
145339|NCT01665001|"~     The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if~     individual therapeutic approach taking into account biological and phenotypic differences as~     well as response at the level of minimal residual disease is associated with improved outcome~     of adults with precursor lymphoid neoplasms~   "
145340|NCT01664988|"~     Gestational hypertension is the main cause of maternal and fetal mortality, however, it has~     no definite effective treatment. nowadays, the stress management approaches are use for~     essential hypertension. So, this study aimed is study the effect of progressive muscular~     relaxation and breathing control technique on blood pressure during pregnancy.~      this 3-groups clinical trial has been done in Mashhad Health Centers and Governmental~     hospitals. 60 pregnant women with systolic blood pressure less than 135 mm Hg or diastolic~     blood pressure more than 85 mm Hg who met inclusion criteria were assigned into three groups~     of progressive muscular relaxation, breathing control and control. In tow experiment groups,~     exercises were controlled by one day personally and the rest by CD, BP before and after~     interventions was controlled for 4 weeks. In control group blood pressure was measured before~     and after 15 minutes with no intervention.~   "
145341|NCT01664975|"~     The purpose of this study is to evaluate the efficacy and safety of GDPT regiment~     (gemcitabine，cisplatin,Prednisone ,Thalidomide~      ) for patients with Peripheral T-cell lymphoma.~   "
145342|NCT01664962|"~     The purpose of this study is to investigate the possibility of an association between~     Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic~     markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase~     (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).~   "
145343|NCT01664949|"~     This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop~     formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops~     (OPTIVE™) in subjects with dry eye disease.~   "
145344|NCT01664936|"~     The purpose of this study is to see if a new way of imaging called the Cerenkov luminescence~     or effect that is used with a standard clinical PET/CT and/or investigation scans can be done~     in order to capture tumor sizes. The investigators believe endoscopies and surgical~     procedures could benefit from this type of imaging in the future. The Cerenkov imaging could~     be used as a guide for surgical resections.~      The purpose of this study is to use the Cerenkov light from FDG, Iodine-131 tracer sand/or~     other investigational tracers to image tumors and its sizes in the head, neck, breast,~     axillary and pelvic regions with a highly sensitive camera. The investigators will be trying~     to see if we can get another picture of the tumor using the Cerenkov light as part of the~     standard clinical scan or therapy.~   "
145345|NCT01664923|"~     The purpose of this study is to determine the safety and efficacy of enzalutamide vs~     bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have~     disease progression despite primary androgen deprivation therapy.~   "
145346|NCT01664910|"~     The goal of this clinical research study is to learn which dose level of inotuzumab~     ozogamicin (CMC-544) work best when given with fludarabine and bendamustine, with or without~     rituximab, before a stem cell transplant.The safety of this treatment will also be studied.~      Fludarabine, bendamustine, and rituximab are commonly given before stem cell transplants.~     These drugs are designed to kill cancerous cells and suppress your immune system in order to~     lower the risk of stem cell transplant rejection.~      Inotuzumab ozogamicin is designed to kill cancerous cells and reduce the risk of the cancer~     coming back.~      This is an investigational study. Inotuzumab ozogamicin is not FDA approved or commercially~     available. It is currently being used for research purposes only.~      All other drugs given on this study are FDA approved and commercially available.~      Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.~   "
145347|NCT01664897|"~     The goal of this clinical research study is to learn if erlotinib can help to control AML.~     The safety of this drug will also be studied.~   "
145348|NCT01664884|"~     The aim of this study is to explore the levels of internalized stigma in a sample of young~     patients with bipolar disorder or schizophrenia.~   "
145349|NCT01664871|"~     There is growing worldwide interest in the use of diammine silver fluoride (DSF) as a topical~     agent to treat dentin hypersensitivity and dental caries. It has been available in various~     formulations for many years, but its safety profile has never been fully characterized.~      This preliminary study determined the applied doses (3 teeth treated), maximum serum~     concentrations, and time to maximum serum concentration for fluoride and silver in 6 adults~     over 4 h. Fluoride was determined using the indirect diffusion method with a fluoride~     selective electrode, and silver was determined using inductively coupled plasma-mass~     spectrometry. The mean amount of DSF solution applied to the 3 teeth was 7.57 mg (6.04 µL).~   "
145350|NCT01664858|"~     CE-MARC 2 is a randomised controlled trial to determine diagnosis and patient management in~     patients presenting to outpatient clinics with suspected stable angina. Cardiac Magnetic~     Resonance Imaging (at 3Tesla) will be evaluated prospectively against current best clinical~     practice (defined by international guidelines). The study hypothesis is that 3Tesla~     CMR-guided management of patients with suspected stable angina is superior to current~     clinical practice based on 1) the principles of the National Institutes for Clinical~     Excellence (NICE) CG95 guidelines (2010); 2) SPECT AHA appropriateness criteria, in terms of~     avoiding study-defined unnecessary invasive coronary angiography.~   "
145351|NCT01664845|"~     The aim of the study is to investigate the treatment response of metformin, Peg-IFN and~     ribavirin combination therapy for chronic hepatitis C virus (HCV).~   "
145352|NCT01664832|"~     The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as~     compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants~     immediately after extubation when recovering from Respiratory distress syndrome (RDS).~      Another objective is to examine the effects for synchronized non-invasive mechanical~     ventilation on gas exchange and cerebral oxygen saturation.~   "
145353|NCT01664819|"~     Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor~     Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from~     1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural~     villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15~     mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no~     significant difference in cataract formation between the antioxidant group and placebo. In~     this follow-up study, we will return to study villages to determine whether rates of cataract~     surgery are different in the 2 groups.~      1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts~     Study: effects of antioxidant supplements on cataract progression in South India. The British~     journal of ophthalmology 2006;90:847-51.~   "
145354|NCT01664806|"~     Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy~     operation. The appearance of burns are common following laparoscopic cholecystectomy;~     particularly at the port site of the active electrode. Willson et al found that 9 out of 19~     skin biopsies from the skin adjacent to the port site of the monopolar instrument's active~     electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997)~     11:653] Authors have speculated that using different generator modes may lead to less~     capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support~     these speculations.~      The investigators hypothesize that capacitive coupling electrosurgical injuries from~     monopolar instruments are occurring during laparoscopic cholecystectomy operations. The~     investigators hypothesize that use of blend modes will reduce the incidence of capacitive~     coupling thermal injuries during laparoscopic operations in comparison to coag modes.~   "
145355|NCT01664793|"~     The purpose of this study is to increase childhood influenza vaccination rates using the FDA~     licensed influenza vaccines according to national guidelines in a randomized cluster trial in~     which primary care offices are randomized to intervention or control with the control group~     receiving the intervention in the second year.~   "
145502|NCT01662661|"~     The purpose of this study is to assess the relative bioavailability (the degree to which the~     study medication becomes available in the blood circulation) of JNJ-47910382, given as an~     uncoated tablet and as a suspension, after a single oral dose of 200 mg in healthy adult~     participants under fed conditions.~   "
145356|NCT01664780|"~     Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI)~     imaging to assess liver fibrosis in patients after orthotopic liver transplantation.~      Material and methods: We prospectively assess the performance of ARFI imaging in planned 100~     patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left~     and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the~     results with clinical data and B-mode criteria.~      ARFI elastometry is an increasingly popular non-invasive method for the assessment of hepatic~     fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically in~     patients after orthotopic liver transplantation. Therefore we want to establish standard~     values in this population.~   "
145357|NCT01664767|"~     The chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the~     airways characterized by fixed airflow obstruction, with important systemic co-morbidities.~     The obstruction is usually progressive and irreversible despite chronic therapy. Cigarette~     smoking is the major cause of this disease. COPD is an important cause of morbidity and~     mortality worldwide. Numerous studies have shown that oxidative stress plays a key role in~     the pathogenesis of COPD. In particular, the active metabolites of oxygen such as superoxide~     anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative~     processes at the cellular level. These molecules can alter the extracellular matrix~     remodeling, cell respiration, cell proliferation, cellular repair and the immune response in~     the lung. All these events are key elements in the pathogenesis of COPD.~      Currently available treatments for COPD (i.e. long-acting bronchodilators and inhaled~     corticosteroids) have not demonstrated a significant in vivo antioxidant effect. The thermal~     inhalation treatments are a therapeutic strategy used since many years in an empirical way in~     patients with COPD. Indeed, the evidence of effectiveness of spa treatment in patients with~     COPD are very limited.~      The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water~     inhalation on oxidant stress in the airways of stable COPD patients.~   "
145358|NCT01664754|"~     This phase I trial studies the side effects and best dose of exemestane in combination with~     pemetrexed disodium and carboplatin in treating post-menopausal women with stage IV non-small~     cell lung cancer. Exemestane may stop the growth of tumor calls by blocking some of the~     enzymes need for cell growth. Drugs used in chemotherapy, such as pemetrexed disodium and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving exemestane together with pemetrexed disodium~     and carboplatin may kill more tumor cells~   "
145359|NCT01664741|"~     The proposed research will provide significant new gender-specific information of scientific~     and clinical relevance on the function of the mu-opioid system in nicotine dependence and~     therapeutic effectiveness of nicotine replacement therapy (NRT). The studies will help to~     explain the differences in the prevalence of smoking in men and women, sex-specific~     differences in nicotine craving and withdrawal as well as the poorer therapeutic response to~     NRT. This work may pave the way to the design of improved pharmacotherapies that can more~     effectively target the endogenous opioid system in the treatment of nicotine dependence.~   "
145360|NCT01664728|"~     The purpose of this study is to provide access to abiraterone acetate for patients who have~     completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and~     continue to receive clinical benefit from this treatment.~   "
145361|NCT01664715|"~     The investigators will conduct a randomized trial to evaluate the effectiveness of 3 levels~     of recommended exercise in initially overweight and obese sedentary men and women on the~     prevention of weight regain. Participants will complete a 3 mo. weight loss intervention of~     decreased energy intake (EI) and increased energy expenditure (100 minutes of physical~     activity per week). Participants achieving clinically significant weight loss (> 5% of~     initial weight), will be randomly assigned to 12 mos. of exercise at levels of energy~     expenditure of exercise (EEEx) recommended by Health and Human Services (HHS), American~     College of Sports Medicine(ACSM), Institute of Medicine (IOM): 150, 225, or 300 minutes per~     week. Major outcome assessments will occur prior to weight loss (-3 mos.), at completion of~     weight loss (0 mos.), at the midpoint (6 mos.), and completion of weight maintenance (12~     mos.).~   "
145362|NCT01664702|"~     The investigators propose a randomized trial comparing higher levels of dairy intake compared~     to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13,~     overweight (>85%) who are currently consuming 1 or fewer servings of dairy per day. Each~     participant will be randomized to either higher or lower levels of dairy intake. A baseline~     calorimeter stay will determine 24-hour energy needs. Participants will then receive the diet~     they have been randomized to receive for 6 days and will then have a second calorimeter stay.~     During this 2nd stay, each participant will continue to receive the diet they were randomized~     to receive and will achieve a 300 kcal energy deficit through physical activity. The~     investigators hypothesize that children who receive a 300 kcal energy deficit from the energy~     expenditure of exercise and receive 3 to 4 servings of dairy products will show greater~     increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of~     exercise and receive 1 or fewer servings of dairy products.~   "
145363|NCT01664689|"~     Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by~     providing endothelial protection, maintaining space, as well as facilitating surgical~     maneuvers, including IOL implantation. Equally important is the ease of use, good~     visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a~     single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2%~     hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these~     in clinical scenarios, there is no randomized trial comparing intraoperative performance and~     postoperative outcomes. The aim of this study was to compare intraoperative performance and~     postoperative outcomes following microcoaxial phacoemulsification when using one of the three~     OVDs~   "
145364|NCT01664676|"~     Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against~     diabetic nephropathy. We hypothesise that this is also the case in humans. This study will~     investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2~     diabetic patients. Impact on basic kidney physiological will be determined and kidney injury~     markers will be measured as surrogate parameters of kidney protection.~   "
145366|NCT01664650|"~     The 15-25% of the population of developed countries suffers for metabolic syndrome. It is~     associated with a 2-4 fold increase in cardiovascular morbility and mortality and with a 5- 9~     fold increase in developing type II diabetes. MS prevalence increases after the onset of~     menopause, because of estrogen deficiency. It is still not clear if menopause itself~     increases the risk of cardiovascular diseases in al women or only in those that develop MS.~     Many MS patients that show slight modification in cardiovascular and metabolic parameters are~     not generally pharmacologically treated since diabetes or alteration in the lipid profile are~     not evidenced. In this respect it is of importance to develop new therapeutic strategies to~     prevent and treat MS. Genistein (4,5,7-trihydroxyisoflavone), shown a potentially preventive~     role on the cardiovascular apparatus in post-menopausal women, may be termed as selective ER~     modulator (SERM), since it reveals both ER-alpha full agonist and ER-beta partial agonist~     activity.~   "
145367|NCT01664637|"~     The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given~     prior to meals three times a day compared to placebo (capsule that looks like active study~     drug but contains no active drug), administered for 12 weeks, in diabetic subjects with~     symptoms associated with gastroparesis.~   "
145368|NCT01664624|"~     The purpose of this study is to assess the effect of roflumilast plus alogliptin on~     glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.~   "
145369|NCT01664611|"~     Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the~     peri/immediate post infarct period. However little is known as to the effect of repeated~     remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on~     ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial,~     the investigators intend to carry out daily remote ischaemic conditioning in post MI~     patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following~     a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic~     resonance imaging.~   "
145370|NCT01664598|"~     This open-label, single arm, multicenter long-term extension study of WA19926 will evaluate~     the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to~     severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible~     patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104~     weeks.~   "
145371|NCT01664585|"~     The aim of this intervention study is to examine whether tailored exercise therapy training~     is effective and cost-effective to decrease headache frequency and intensity, reduce~     medication used for chronic headache and patients´ absence from work, improve their neck~     muscle force, cervical spine mobility, functional ability and quality of life, and increase~     general physical activity in chronic headache women at regular work during a 6-month~     intervention.~      The intervention itself with pilot-tested upper-neck specific exercise regimen aims that~     patients would independently commit to train and exercise to reduce their headache, and thus~     increase their quality of life. In addition, reduced pain and frequency of headache may~     increase the objectively measured daily physical activity of chronic headache patients.~   "
145372|NCT01664572|"~     Microcirculation, especially skin microcirculation, is a window towards systemic vascular~     function in magnitude and underlying mechanisms. Different techniques have been developed to~     assess the microcirculation. Among these techniques, laser technology is used to perform~     non-invasive microvascular assessments. Although this technique is widely used, different~     methodological issues remain. This study aims at defining the way to use lasers for clinical~     use.~   "
145373|NCT01664559|"~     Intrauterine device (IUD) placement can be painful for patients during and after the~     procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly~     effective long acting reversible contraception. Currently there are no proven effective~     methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and~     Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after~     IUD insertion although it is used by some providers for this purpose. It is a strong NSAID~     that is indicated for the treatment of moderate acute pain. In the intramuscular form it has~     an analgesia onset of action at 30min, thus may be a plausible option for pain management in~     the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia~     and have not been proven to be effective in reducing pain associated with IUD placement. The~     primary aim of this study is to determine whether ketorolac (Toradol) decreases pain~     associated with intrauterine device placement compared to placebo. We hypothesize that~     administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion~     will decrease pain scores by at least 20mm on a visual analog scale at various time points~     during IUD insertion when compared to placebo of normal saline injection.~   "
145374|NCT01664546|"~     An Observational, blind and prospective study of Preimplantational Aneuploidy Screening by~     aCGH in Trophectoderm Biopsy~   "
145375|NCT01664533|"~     This prospective, multicenter observational study will evaluate the efficacy, safety, and~     tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally~     advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after~     pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until~     withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.~   "
145376|NCT01664520|"~     The purpose of this study is to investigate how dexmedetomidine affects static and dynamic~     autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal~     subarachnoid haemorrhage (SAH) patients.~   "
145377|NCT01664507|"~     Croup is common illness presenting emergency department with dyspnea. The main treatment for~     croup is nebulized L-epinephrine and steroid. The study for the dose of nebulized~     L-epinephrine is restricted that the study of comparision between racemic epinephrine and~     L-epinephrine.~      The investigators conducted this study to compare the effectiveness of low dose L-epinephrine~     with conventional dose L-epinephrine.~   "
145378|NCT01664494|"~     This multi-center observational study will evaluate the use of Xeloda (capecitabine) in~     patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced~     gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving~     treatment with Xeloda according to product label will be followed for up to 10 months.~   "
145379|NCT01664273|"~     Gene transfer by electroporation (gene electrotransfer) uses short electric pulses to~     transiently permeabilise the cell membrane enabling passage of plasmid DNA into the cell~     cytosol. It is an efficient non-viral method for gene delivery to various tissues. In this~     phase I dose-escalating study, patients will be treated with intramuscular gene~     electrotransfer of plasmid AMEP. Plasmid AMEP encodes protein AMEP which bind to α5β1 og αvβ3~     integrins. Primary end point of the trial is safety and secondary end points are efficacy,~     pharmacokinetics and evaluation of potential discomfort associated with the treatment~     procedure using VAS (Visual Analogue Scale).~   "
145380|NCT01664260|"~     It has been suggested that N-acetylcysteine exerts neuroprotective effects by regulating~     neurotransmitters and cell signaling pathways. We hypothesize that oral N-acetylcysteine~     augmentation will help reduce symptoms in patients with posttraumatic stress disorder as well~     as improve cognitive functions. We also expect that the N-acetylcysteine augmentation will~     induce change in structural, functional, and neurochemical aspects of the brain.~      In this study, we plan to conduct a randomized, double-blind, placebo-controlled augmentation~     study with N-acetylcysteine in addition to escitalopram. We will assess the efficacy and~     safety of the N-acetylcysteine augmentation.~   "
145381|NCT01664247|"~     This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial~     is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide~     (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type~     2 diabetes qualifying for treatment intensification.~   "
145382|NCT01664234|"~     Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study.~     Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins,~     trisomy 21, or similar congenital malformations. Patients with American Society of~     Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital~     heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy~     with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by~     a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.~     Randomization (1:1) will be based on computer-generated codes with random block sizes and~     stratified by hospital; allocation will be concealed and provided to clinicians via a secure~     web site that will be accessed shortly before induction of anesthesia.~   "
145383|NCT01664221|"~     The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and~     pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects~     following administration of multiple intravenous dose. The objective of this randomized,~     parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of~     the test drug Eritromax® marketed by Blau Farmacêutica, compared to the comparator drug~     Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the~     reticulocyte count following a multiple intravenous administration during 4 weeks of 100~     IU/kg in healthy subjects.~   "
145384|NCT01664195|"~     The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and~     pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects~     following administration of single intravenous dose. The objective of this randomized,~     crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of~     the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced~     by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count~     following a single-dose intravenous administration of 100 IU/kg in healthy subjects.~   "
145385|NCT01664182|"~     This randomized phase II trial studies how well trebananib with or without bevacizumab,~     pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate works in treating patients~     with kidney cancer that has spread to other places in the body and usually cannot be cured or~     controlled with treatment. Trebananib may stop the growth of tumor cells by blocking blood~     flow to the tumor. Bevacizumab, pazopanib hydrochloride, sorafenib tosylate, and sunitinib~     malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth or by blocking blood flow to the tumor. It is not yet known whether giving trebananib~     with or without bevacizumab, pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate~     is more effective in treating kidney cancer.~   "
145386|NCT01664169|"~     RATIONALE: Studying plasma samples from patients with pancreatic cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with pancreatic~     cancer treated on study CALGB-80303.~   "
145387|NCT01664156|"~     1. Objectives~             1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet~               in women~             2. to establish scientific evidence for the use of Korean red ginseng by investigating~               changes of infrared thermography~        2. Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity~          of hands and feet more effectively than placebo after 8 weeks administration of~          interventions- Korean red ginseng or the placebo.~   "
145388|NCT01664143|"~     This single-center, randomized, double-blind, placebo-controlled study will evaluate the~     safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers~     will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time~     on study treatment is 14 days.~   "
145389|NCT01664130|"~     This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating~     patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able~     to send x-rays directly to the tumor and cause less damage to normal tissue~   "
145390|NCT01664117|"~     This observational multicenter study will evaluate the management of disease and safety in~     clinical practice in patients with moderate to severe rheumatoid arthritis receiving any~     biological therapies in monotherapy.~   "
145391|NCT01664104|"~     This observational, multi-center study will evaluate the treatment regimen, treatment~     responses and safety of tocilizumab therapy in a routine clinical practice in participants~     with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a~     maximum study duration of 18 months.~   "
145772|NCT01659086|"~     The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of~     different formulations of a two-dose primary series and booster vaccination of monovalent~     Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18~     to 64 years of age.~   "
145392|NCT01664091|"~     This research study is being done to carefully evaluate the effect of giving radiation~     therapy after temporary breast reconstruction. The investigators want to see if this type of~     reconstruction combined with radiation will look better (once the final reconstruction has~     been completed) and will reduce the risk that the participant will develop complications that~     sometimes occur with other kinds of reconstruction procedures. The investigators also want to~     know if it is easier to give the radiation with this type of reconstruction than with other~     kinds of reconstruction procedures. The reconstruction procedure involves the temporary use~     of a tissue expander and an acellular dermal matrix (ADM).~   "
145393|NCT01664078|"~     The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects~     with abdominal aortic aneurysms requiring endovascular repair.~   "
145394|NCT01664065|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     Ceftaroline in a group of patients with renal disease and matching healthy subjects with~     normal renal function~   "
145395|NCT01664052|"~     This study has been designed to evaluate an investigational model of the Essure System for~     Permanent Birth Control. The investigational device is designed to offer all the advantages~     of the currently approved device. In addition, the investigational device offers immediate,~     permanent contraception without a three-month waiting period or 90-day confirmation test.~     This study has been designed to evaluate the effectiveness of the investigational device in~     causing tubal occlusion from insert placement through three months of wearing.~   "
145396|NCT01664039|"~     The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular~     pressure (IOP) and ocular surface and inflammatory biomarkers.~   "
145397|NCT01664026|"~     To evaluate the effect of a 6-month web-based lifestyle modification program with and without~     telephone counseling versus usual care in obese patients with cardiovascular risk factors on:~        -  Weight Loss~        -  Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol,~          HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.~        -  Physical activity and eating habits~        -  Quality of life~   "
145398|NCT01664013|"~     The purpose of this study is to investigate the impact of botulinum toxin treatment in~     quality of life(QoL) in cervical dystonia patients~   "
145399|NCT01664000|"~     In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important~     role in protecting the body. p53 functions by activating proteins that repair DNA and kill~     cells that have genetic mutations such as in cancers. Research experiments showed that when~     cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that~     inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis),~     a protein that causes tumor cell death. Because of these activities, slowing cancer cell~     growth and causing cancer cell death, Kevetrin may help to treat tumors.~   "
145400|NCT01663987|"~     A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess~     the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in~     Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an~     acute exacerbation (Hospital Discharge 1)~   "
145401|NCT01663974|"~     The study aims to evaluate:~        -  the frequency of subsyndromal symptoms or disorders observed during interepisode phases~          in bipolar patients, particularly after a depressive episode in which these subsyndromal~          disorders are the most frequent~        -  the functional impact of these disorders, factors or symptom thresholds associated with~          functional remission, and factors associated with symptomatic remission over a~          sufficient follow-up (12 months).~   "
145402|NCT01663961|"~     A study that evaluates the interaction in healthy subjects of the heart drug Digoxin on~     YM178, when the latter is taken on a continuous basis, in order to establish that there is no~     risk to patients who may take this combination of drugs.~   "
145403|NCT01663948|"~     The purpose of the international plastic bronchitis registry is to understand the natural~     course and long term health outcomes of subjects diagnosed with plastic bronchitis due to~     different types of casts. This provides essential data for identifying best practices and~     treatments. The secondary aim is to understand the structure of casts and mechanism of their~     formation.~   "
145404|NCT01663935|"~     The purpose of the study is to evaluate and document physiologic and functional changes in~     visual performance and retinal function of patients diagnosed with albinism (a dopamine~     deficiency state) following a trial of oral Levodopa/carbidopa treatment.~   "
145405|NCT01663922|"~     The purpose of the study is to look at whether taking a new medication for hepatitis C~     (boceprevir) together with a herbal remedy commonly used for the treatment of depression~     (SJW) has any effect on the levels of boceprevir in the blood, compared to when boceprevir is~     taken on its own.~      Treatment of hepatitis C genotype-1, has recently been significantly improved with the~     addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to this~     class of antiviral drugs and it is administered in combinations with other drugs to treat~     hepatitis C. One of the common side effects of treatment for hepatitis C is low mood~     (depression) for which treated patients may self-medicate with preparations containing St.~     Johns Wort (SJW).~      SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may~     result in a change in how both of these drugs usually work. It is therefore important to find~     out if the levels of boceprevir in the blood are significantly affected by taking SJW.~      The study aims to help us understand whether it will be safe to take SJW whilst being~     simultaneously treated for hepatitis C with boceprevir.~   "
145406|NCT01663909|"~     Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain~     management a complex task. Several studies have found out that pharmacological interventions~     alone were not enough to provide optimal pain management for these patients. The~     investigators developed a DVD on guided imagery, customized for teenagers, to help them cope~     better with their pain. The investigators believe that this type of intervention combined~     with their usual analgesic medication will help them to control their pain and foster~     rehabilitation.~   "
145407|NCT01663896|"~     To define and evaluate OCT stent guidance parameters through prospective data collection in~     PCI procedures of de novo lesions.~   "
145408|NCT01663883|"~     Constant despite changes in perfusion pressure. It is observed in many vascular beds of the~     human body to prevent that variations in perfusion pressure are directly transmitted into~     changes in blood flow. This is necessary to prevent ischemia and/or hypoxia during decreased~     blood flow and bleeding or increased capillary pressure during increased blood flow.~      In the eye, several studies have reported that retinal blood flow is autoregulated over a~     wide range of ocular perfusion pressures. Unfortunately only few data are available for the~     optic nerve head. To gain data about autoregulation is of special importance given that~     several important ocular diseases such as glaucoma and age-related macular degeneration are~     associated with impaired autoregulation. In humans most data were collected using laser~     Doppler flowmetry.~      The present study aims to investigate the phenomenon of transient reduction in blood flow and~     to gain insight in the regulatory mechanisms of optic nerve head blood flow during isometric~     exercise.~   "
145409|NCT01663870|"~     The goal of this research study to learn about breast cancer survivorship and possible ways~     to improve breast cancer survivorship programs using technology.~      Objectives:~      Objective 1: Assess breast cancer survivors on the acceptability of and preferences for the~     integration of patient navigation and an eHealth technology platform to improve care in the~     Survivorship Clinic at Lyndon B. Johnson Hospital.~      Objective 2: Assess clinic stakeholders acceptability of and preferences for the integration~     of patient navigation and an eHealth technology platform to improve care for breast cancer~     patients in the Survivorship Clinic at Lyndon B. Johnson Hospital.~   "
145410|NCT01663857|"~     A study for women with ovarian cancer that has returned at least 6 months after~     platinum-based chemotherapy.~   "
145411|NCT01663844|"~     This study includes two sub-trials. Both are included in this singe registration since they~     have parallel inclusion of participants and have been approved by the Swedish ethics board~     together in one application.~      Trial 1 includes patients with both insomnia and major or minor depression. Participants are~     randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or~     to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The~     primary purpose is to evaluate changes in insomnia and depression severity for the~     combination treatment compared to the depression treatment, after treatment and at 6 and 36~     months follow up. A secondary purpose is to evaluate cognitive functioning before and after~     treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through~     mass media and the Internet psychiatry clinic's regular patient recruitment.~      Trial 2 includes patients with insomnia who do not meet criteria for major or minor~     depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks~     patients that are judged to be at risk of treatment failure are randomized to either~     continued treatment or treatment with added support intended to enhance outcome. The primary~     purpose is to evaluate change in insomnia severity for participants who get added support,~     compared to continued treatment with regular support level. A secondary purpose is to~     evaluate cognitive functioning before and after treatment, as well as cost effectiveness.~     Recruitment is done in the Stockholm County through mass media and the Internet psychiatry~     clinic's regular patient recruitment.~      NOTE:~      The first participants in trial 1 will be regarded as pilots, due to problems with the~     experimental treatment: technical issues as well as problems with the design of treatment~     modules. These problems were corrected when discovered. 12 participants in the experimental~     arm were affected by these errors. The pilot participants will not be included in the main~     analyses of data. This was decided upon on 31st of October 2014.~   "
145412|NCT01663831|"~     The scaling up of Long Lasting Insecticidal Nets (LLIN) and the expansion of Indoor Residual~     Spraying (IRS) has contributed to a significant decrease of malaria worldwide. However these~     control methods tackle only indoor and night biting vectors. The proportion of transmission~     occurring outdoors and before sleeping hours or so-called residual transmission is steadily~     increasing and may compromise the effort towards malaria elimination.~      The purpose of this study is to raise evidence on the effectiveness of mass use of topical~     repellents in addition to LLINs in controlling malaria infections.~      A multidisciplinary approach will be used to collect information on the most important~     factors that contribute to the successful reduction of residual malaria transmission. In a~     first objective the epidemiological efficacy of repellents on prevalence of malaria carriers~     and malaria incidence will be assessed. To achieve this goal 98 communities will be randomly~     assigned to one of two treatment arms (LLIN and LLIN + repellent). Within a community a cross~     sectional random sample of 65 people will be drawn at the beginning and the end of the~     malaria season to obtain an estimate of the malaria prevalence. The second objective will~     handle the entomological efficacy and persistence of the topical repellent on malaria~     vectors. And lastly the acceptability, adherence and adequacy of the topical repellents will~     be studied in a third objective.~   "
145413|NCT01663818|"~     A multi-center, post-CE Mark study designed to evaluate the performance of the Intact~     Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.;~     post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty~     (PTA) of superficial femoral or popliteal artery(ies).~   "
145414|NCT01663805|"~     This is an open, randomized, single-center study. The selected patients will be first divided~     into two major groups according to the type of organ to be transplanted: standard criteria~     donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to~     one of the treatments: tacrolimus (TAC) or everolimus (EVL).~      All patients received induction therapy with basiliximab (BXB) and maintenance with~     Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary~     objectives: To characterize the molecular profile of cytokines in kidneys obtained from~     deceased donors such as standard (SCD) and extended criteria (ECD) in biopsies taken before~     and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in~     the expression of these molecules. And as Secondaries objectives: To correlate the pattern of~     cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection~     and patient and graft survival.~   "
145415|NCT01663792|"~     Could daily consumption of seaweed help explain lower postmenopausal breast cancer (BC)~     incidence and mortality rates in Japan? This small proof of principle clinical trial was~     designed to test the idea that the same amount of seaweed normally eaten in Japan would~     induce metabolic changes when given to non-seaweed consuming healthy postmenopausal American~     women. The participants were given 10 capsules a day (about 1 tablespoon) for 3 months.~     During the first month the capsules contained placebo, the second month seaweed, and the~     third month placebo. We collected blood and urine samples after each treatment period and~     tested for changes in protein expression that might be related to consuming seaweed.~   "
145486|NCT01662869|"~     This randomized, multicenter, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid,~     and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor~     (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction.~     Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in~     combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until~     disease progression, unacceptable toxicity, participant or physician decision to discontinue~     treatment.~   "
145416|NCT01663779|"~     Arterial catheterization is frequently performed on critically ill patients for invasive~     blood pressure monitoring and/or frequent blood draws, especially arterial blood gas~     analysis. The distal part of the radial artery (wrist) is the preferred access site.~      The potential complications of the procedure are mostly minor and comprise temporary~     occlusion of the radial artery (RA), hematoma, local infection or bleeding from the puncture~     site. Major complications including vessel aneurysm or occlusion with threat to hand~     viability are rare.~      The standard approach to catheterization is blind puncture of the RA while locating its~     pulse by palpation, followed by threading a 20 Gauge (20G) angio-catheter into the vessel.~     Alternatively ultrasound can be used to locate the vessel and guide needle insertion.~      To our knowledge, four prospective randomized trials (PRT)5-8 comparing palpation with~     ultrasound-guided RA catheterization have been conducted so far and one meta-analysis looked~     at the pooled data obtained from these. The results showed that ultrasound guidance increased~     the first-attempt success rate at RA catheterization by 71% compared to palpation. The use of~     ultrasound also significantly reduced the time to successful catheterization, the number of~     punctures as well as the amount of catheters required per procedure.~      None of the prior randomized trials has been conducted in an ICU setting and in three out of~     the four studies the arterial lines were placed in patients undergoing elective surgery. The~     investigators hypothesized that ultrasound could improve first attempt success rate while~     placing arterial catheters in an ICU setting. Ultrasound may also reduce total time to~     successful insertion and reduce complications.~      The investigators plan to randomize patients to either a palpation technique or ultrasound~     guided catheter insertion and record the above outcomes.~   "
145417|NCT01663766|"~     This study will assess the safety and tolerability of milatuzumab (IMMU-115) when added to a~     standard regimen to prevent Graft vs. Host Disease (GVHD) in patients with hematologic~     malignancies undergoing stem cell transplant.~   "
145418|NCT01663753|"~     Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and~     brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment.~     Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to~     treatment before surgery. A positive predictive value of 75% was found in a small study~     making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach.~     Diffusion-weighted MRI was also described as an early and sensitive indicator in other~     diseases.~      Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in~     the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary~     objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted~     MRI diagnostic performances.~      Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2~     cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a~     18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the~     brachytherapy. The total follow-up duration (study participation) of patients will be 11~     weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until~     18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.~      Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to~     assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it~     could improve clinical practices and be helpful to decide whether the patient needs surgery~     or not after radiochemotherapy and brachytherapy.~   "
145419|NCT01663740|"~     This observational study will compare spermatogenesis in male adult renal transplant~     recipients receiving valganciclovir versus untreated matched controls. Data will be collected~     from each patient for up to 52 weeks post transplant.~   "
145420|NCT01663727|"~     This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to~     evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel~     in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast~     cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All~     patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks~     during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV~     infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease~     progression, unacceptable toxicity or death from any cause occurs.~   "
145421|NCT01663714|"~     This is a phase II, open-label, multicenter study of the efficacy and safety of sequential~     administration of CVP x 6 followed by tositumomab and iodine I 131 tositumomab (formerly~     referred to as tositumomab and iodine I 131 tositumomab). All patients who complete three~     cycles of CVP, regardless of response, will be eligible for treatment with tositumomab and~     iodine I 131 tositumomab. Subjects who have rapidly progressive disease prior to completing~     three cycles of CVP may be removed from study.~      In order to proceed to tositumomab and iodine I 131 tositumomab therapy, patients must have~     completed six cycles of CVP within 20 weeks as described. Patients may proceed to Iodine-131~     Anti-B1 Antibody if they have progressive disease documented at the response evaluation~     following 6 cycles of CVP. In addition, patients must still meet the eligibility inclusion~     exclusion criteria based upon the week 20 assessments, as applicable. Patients must also have~     an average of ≤25% bone marrow involved by NHL to receive treatment with tositumomab and~     iodine I 131 tositumomab. The dosimetric dose of tositumomab and iodine I 131 tositumomab~     must be given within 28 days of the response evaluation following CVP and no later than 56~     days from the first day of the sixth cycle of CVP.~   "
145422|NCT01663701|"~     This study is a randomized control trial assessing the impact of a simple evidence-based~     protocol for the treatment severe sepsis with hypotension in Zambia. This is a follow-up~     study to the Simplified Severe Sepsis Protocol (SSSP) study. The intervention protocol~     consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and~     blood transfusion when necessary. It is hypothesized that the protocol will significantly~     decrease in-hospital mortality in patients with severe sepsis and hypotension.~   "
145423|NCT01663688|"~     The purpose of this clinical study is to collect and evaluate the data from eye scans using~     an investigational three-dimensional eye imaging photography device called the Nidek Optical~     Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique~     that uses invisible wavelengths of light to make detailed images of the tissues at the back~     of the eye. These images provide information that physicians may use to help diagnose eye~     conditions and/or to monitor changes in the eye during treatment.~   "
145487|NCT01662856|"~     The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols~     provides a measurable benefit when compared to hemostasis achieved through conventional~     surgical technique (suture) and by standard hemostatic action, such as mechanical pressure~     through manual compression. This study has a Preliminary Part (I) in which all subjects are~     treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized~     in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.~   "
145424|NCT01663675|"~     Trisomy 21 or Down syndrome, is the most common genetic cause of cognitive disability.~     Currently, in Alsace, the birth prevalence is about 1 in 1600 live births, which means 10~     liveborns with Down syndrome each year.If screening and prenatal diagnosis of children with~     trisomy 21, as well as medical care, social and educational integration in childhood was the~     subject of much research and has led to remarkable progress in terms of health and medical~     care, it is not the same for the knowledge about adolescents and adults.Despite a more and~     more higher life expectancy, the evolution of trisomy 21 in adulthood is often marked by a~     deterioration in health status, with a regression of acquired psychomotor skills, often~     attributed only to the precocious occurrence of Alzheimer's dementia. Nevertheless, it seems~     that the diagnosis of Alzheimer's dementia is often overdiagnosed, and it is well established~     that only a fraction of Down syndrome patients will develop this type of dementia. Too often~     a decline in general health, behavioral changes and decreased cognitive abilities are only~     attributed to the Down syndrome with an early dementia without looking for an underlying,~     potentially curable, disease.This study aims to better evaluate the health and social status~     of 100 adults with trisomy 21 in Alsace. The medical evaluation will include a comprehensive~     assessment of health status and quality of life conducted by the geneticist, a cardiac,~     sensory, hormonal, biological and radiological evaluation. A speech-language and psychomotor~     evaluation will also be conducted. A psychiatric consultation and a psychometric assessment~     will aim to assess cognitive function and to search for associated mood disorders.The~     expected results are to better know the natural history of trisomy 21 in adulthood, with the~     determination of the frequency of morbid events specific to adulthood, and also to improve~     the medical and paramedical care with the establishment of a monitoring program to prevent~     the occurrence of these morbid events.~   "
145425|NCT01663662|"~     It is well known that the use of loop diuretics in acute setting may decrease glomerular~     filtration rate (GFR) and increase serum creatinine leading to renal dysfunction. Loop~     diuretic induced elevation in serum creatinine can lead to increase in length of hospital~     stay and possibly morbidity. Previous studies have suggested that tolvaptan unlike aggressive~     loop diuretic therapy may not activate neurohormonal system nor decrease renal blood flow.~     These properties may make tolvaptan a useful addition to diuretic therapy to prevent renal~     dysfunction in high-risk patients. Therefore the primary objective of this study is to~     determine if the use of tolvaptan in combination with diuretic therapy may prevent~     development of renal dysfunction in high risk patients with heart failure.~      Hypothesis: Administration of tolvaptan in combination with continuous loop diuretic therapy~     in acutely decompensated heart failure patients at high risk for developing diuretic induced~     renal dysfunction will have a lower proportion of patients increasing their serum creatinine~     > 0.3 mg/dL within a 96 hour time frame as compared to patients just receiving standard of~     care continuous infusion diuretic.~   "
145426|NCT01663649|"~     200 persons (100 with multiple sclerosis and 100 with epilepsy) with depressive symptoms are~     recruited via the multiple sclerosis clinics of the University Medical Center~     Hamburg-Eppendorf and the epilepsy centre Alsterdorf and randomly assigned either to the~     online program deprexis or to a wait-list control condition. All participants receive~     free-of-charge online access to deprexis either immediately or with a six month delay.~      At three time points (1. prior to intervention, 2. after completion of the intervention nine~     weeks later and 3. at follow-up six month later), both groups are assessed via an anonymous~     online survey, which was implemented using the software package OPST®.~      The survey consists of different questionnaires. The Beck Depression Inventory (BDI)~     represents the primary outcome (IIT analysis for pre versus post). It is assumed that the~     severity of depressive symptoms will improve to a significantly greater extent in the~     deprexis than in the wait-list control condition in the course of nine weeks and will be~     maintained in a six month follow-up.~   "
145427|NCT01663636|"~     To pilot test a mobile phone SMS system that will provide periodical messaging texts to~     mothers or custodians of infants who come for their first dose vaccines within the first 3~     months of life to improve timely immunization coverage, vaccine acceptance and ensure vaccine~     safety monitoring. The intervention will include a cloud-based information system alimented~     by mobile phone data entry at the health post nurse level, that links child vaccination~     status and is able to remind parents and nurses of the need for next vaccination appointment~     and provide a system for reporting of adverse events following immunization in the immediate~     post-vaccination period.~   "
145428|NCT01663623|"~     The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination~     with azathioprine, for the maintenance of remission following a standard induction regimen in~     patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in~     this study is 1 to 1 which means that participants have an equal chance of receiving~     belimumab or placebo.~   "
145429|NCT01663610|"~     This study is a randomized controlled trial (RCT) to evaluate the effect of an~     internet-based, guided self-help course for individuals who have recivied an ADHD diagnsis or~     struggle with organizing daily life and/or easily get distracted. The course (vardagsSMART)~     teach the participants how to use a Smartphone to better organize their everday life and will~     be compared to a wait list control group (CONT) that later will recieve the same course~     without guidance from a supervisor(selfSMART). It is hypothesized that VardagsSMART will be~     superior to CONT on ability to organize everyday life and ADHD-symptoms, and that~     vardagsSMART will be superior to selfSMART on adherence, understanding and perecived~     usefullness.~   "
145430|NCT01663597|"~     Aberrations play a significant role in the visual process and can be divided in lower-order~     and higher-order aberrations. The former can be measured using the commercially available IOL~     Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity.~     Higher-order aberrations do not significantly influence visual acuity but affect the quality~     of vision and can cause halos, double vision, and night vision disturbances.~      Background Cataract surgery has become a routine procedure in the developed countries. During~     this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However,~     these lenses do not account for individual optical biometry data or aberrations. Therefore,~     it is important to provide data for ametropic and emmetropic eyes as this information might~     improve future intraocular lens design and lead to individually adapted lenses for yielding~     optimal visual acuity and quality results.~      The aim of the present study is to clarify the correlation between refractive errors/axial~     eye length and spherical aberrations of the cornea.~   "
145488|NCT01662843|"~     The B-RIPPED scan is a standardized ultrasound evaluation of pulmonary B-lines, Right~     ventricle size and strain, Inferior Vena Cava collapsibility, Pleural and Pericardial~     Effusion, Pneumothorax, Ejection Fraction, and lower extremity Deep Venous Thrombosis.~     Primary outcomes measured are the magnitude of change in differential diagnoses.~   "
145489|NCT01662830|"~     The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump~     Start (Medifast's 5 & 1) Plan on the following indices: weight loss, anthropometric changes,~     and reduction in common markers of coronary heart disease.~   "
145431|NCT01663584|"~     The purpose of this study is to collect blood samples to enable validation of genetic testing~     for diseases within a multi-disease carrier screening panel. Samples will be collected from~     adult women or men who have previously tested positive as carriers for various recessive~     conditions. These are healthy adults who carry a mutation that might place them at increased~     risk of having a child with a specific genetic disorder. Study participation will be open to~     adults that were previously tested as part of their routine medical care and where test~     results demonstrated positive carrier status for a specific genetic disease. Samples will be~     tested for the disease mutation for which the subjects provides documentation of prior~     testing.~   "
145432|NCT01663571|"~     Protocol Summary~      Constitutive STAT3 activity is implicated in many malignancies including Cutaneous T Cell~     Lymphoma. It is also essential for Th17 differentiation, a subset of CD4 effector T cell,~     implicated in chronic inflammatory conditions and possibly CTCL. HDAC inhibitors have shown~     activity in CTCL but their exact mechanism of action is not known. It is known that HDAC~     inhibitors regulate STAT3 transcriptional activity and hence can potentially be active in~     CTCL through modulation of the STAT3 pathway. The hypothesis is that Th17 cytokines~     contribute to the initiation of cancer by creating a pro-inflammatory microenvironment that~     predisposes cells to neoplastic transformation. To probe this, the investigators will compare~     the differences in cytokine production and gene expression in the skin resident T cells from~     patients with benign dermatoses and CTCL as well as in the blood/circulating lymphocytes of~     healthy donors and Sezary syndrome (SS). The investigators will also investigate whether HDAC~     inhibitors have a direct impact on the number of Th17 cells, the cytokine production by these~     cells and phosphorylated STAT3 protein in CTCL with subsequent treatment cycles.~      The objectives of this study are 1. Observe the epigenetic, transcriptional and phenotypic~     changes that take place in T cell during malignant transformation 2. Understand the mechanism~     of action of HDAC inhibitors in CTCL.~      Methods: Skin biopsy specimens from cutaneous T cell lymphoma (CTCL) patients and benign skin~     conditions namely eczema, dermatitis and psoriasis will be obtained through a standard punch~     biopsy procedure from the skin lesion.~      Additionally, 15 ml of peripheral blood from CTCL patients who have Sezary syndrome (SS) and~     from patients with benign skin condition will be collected.~      CTCL patients, who are starting treatment with HDAC Inhibitors namely Vorinostat and~     Romidepsin, will have a total of 3 skin biopsies and/or blood draws. The first procedure~     would be before starting treatment with either of these HDAC inhibitors. Two more skin~     biopsies and/or blood draws will be performed after first and second cycle of treatment.~      Levels of Th17 cytokines, IL-17, IL -22 and pSTAT3 protein will be determined by IHC staining~     in the skin and cytokine levels in the blood will be assayed by sandwich ELISA method.The~     investigators will also assay the mRNA levels of the transcription factors of the different T~     effector cells by qPCR.~   "
145433|NCT01663558|"~     Context:~      Men who have sex with men (MSM) are at increased risk for HPV-related anal neoplasia and anal~     squamous cell carcinoma; concomitant HIV infection roughly doubles that risk.~      Objectives:~        1. To compare the efficacy of ablative therapy to topical imiquimod therapy in the~          management of anal dysplasia in HIV-infected men.~        2. To describe relationship between cytologic grade of anal dysplasia (as reported on~          screening anal Pap test) and pathologic grade reported on anal mucosa histopathologic~          examination.~        3. To describe demographic, sexual practices, HPV-specific, and HIV-specific correlates of~          anal dysplasia.~        4. To describe adverse effects associated with ablative therapy and topical imiquimod~          therapy.~      Design:~      Prospective, randomized controlled clinical trial. This will be a pilot study. All subjects~     will undergo baseline anal Pap, HRA with biopsies as indicated, and anal HPV testing. If AIN~     2 or 3 is discovered on histopathologic examination, subject will be offered observation only~     or treatment. If he chooses treatment, he will be randomized to: 1) imiquimod anal~     suppositories three times weekly for 3 months, or 2) appropriate ablative therapy as~     determined by colorectal surgeon. During imiquimod treatment (not applicable to ablative~     group as their treatment will be completed in one visit) subjects will be followed for 2~     weeks, 4 weeks, 8 weeks, and 12 weeks with anal Pap, HRA with biopsies as indicated, and anal~     HPV testing. After therapy completed in each treatment group, subjects will be followed for 1~     month, 3 months, 6 months, 9 months, and 12 months post-therapy with anal Pap, HRA with~     biopsies as indicated, and anal HPV testing. Observation only subjects will be evaluated~     every 3 months with anal Pap, HRA with biopsies as indicated, and anal HPV testing for 12~     months. We have chosen a goal of 30 subjects in each treatment group and 10 subjects in the~     observation only group based on the likelihood of enrolling a study of this type in a~     reasonable amount of time.~      Main Outcome Measures:~        1. Anal Pap cytologic grade, including regression and recurrence during course of study~        2. HPV type in anal canal, including regression and recurrence during course of study~        3. Anal histology, including regression and recurrence during course of study~        4. Adverse effects experienced during treatment, recorded in symptom log~   "
145434|NCT01663545|"~     Background:~        -  The brain is protected by a barrier that keeps toxins in the blood from reaching the~          brain. However, this barrier can also keep useful medications from reaching the brain.~          P-glycoprotein (P-gp) is a brain protein that is part of the blood-brain barrier. The~          level of P-gp is higher in people with epilepsy than in people without epilepsy. These~          different levels of P-gp may explain why some people have seizures that do not respond~          well to medications. Researchers want to see if P-gp can affect the response to epilepsy~          medications.~        -  Epilepsy may also be associated with brain inflammation. Researchers also want to look~          at the part of the brain affected by epilepsy to see if inflammation is present.~      Objectives:~        -  To see if P-gp can affect the response to epilepsy medications.~        -  To see if inflammation is present in the part of the brain affected by epilepsy.~      Eligibility:~        -  <TAB>Individuals between 18 and 60 years of age who have temporal lobe epilepsy. We plan~          to study some patients whose seizures are well controlled by drugs, and some whose~          seizures are not controlled.~        -  <TAB>~        -  Healthy volunteers between 18 and 60 years of age.~      Design:~        -  This study requires four or five visits to the NIH Clinical Center over the course of a~          year. The visits will be outpatient visits and will last from 2 to 5 hours.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  All participants will have two positron emission tomography (PET) scans. The scans will~          take place during different visits. Different drugs will be used in each scan. One drug~          will be used to temporarily block the effect of P-gp in the brain. The other drug will~          show areas of inflammation in the brain.~        -  Participants with epilepsy will have a third PET scan. This scan will also look at P-gp~          activity in the brain. However, it will not use the drug that blocks the effect of P-gp.~        -  All participants will also have one magnetic resonance imaging scan. This scan will help~          show brain function.~   "
145435|NCT01663532|"~     The primary purpose of this study is to evaluate the overall efficacy of aripiprazole~     intramuscular (IM) depot as acute treatment in subjects with schizophrenia.~      The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot~     administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.~   "
145436|NCT01663519|"~     Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients~     at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1%~     to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines~     Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the~     feet, education and prescription of insoles in combination with well fitting shoes are~     supposed to decrease the risk of ulcers and prevent amputation. Further research is, however,~     needed to evaluate the effectiveness of these commonly prescribed insoles. The aim of this~     study is to compare three different types of insoles with respect to pressure distribution.~     Every 6 months follow-up is assessed until 24 months is reached.~   "
145437|NCT01663506|"~     This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra~     (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients~     initiated on RoActemra/Actemra treatment according to the local label will be followed for 12~     months.~   "
145438|NCT01663493|"~     This study will examine whether there is any difference in number of passes needed to~     diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different~     types of needles.~   "
145490|NCT01662817|"~     The purpose of this study is to assess the effectiveness of systematic screening for~     depression in high-risk patient participants in everyday clinical practice. Systematic~     screening for depression in high-risk patients is recommended to be included as a usual~     practice but its effectiveness in this context remains controversial. In this study, 35~     primary care physicians (PCPs) in Spain were assigned to intervention (receive one day~     training in depression screening guidelines and use guidelines for six months) and 34 PCPs~     were assigned to a control group (manage depression in the usual way for six months). There~     were a total of 525 patient participants with MDD.~   "
145439|NCT01663480|"~     The primary purpose of mechanical ventilation is to sufficiently unload the respiratory~     muscles and maintain adequate ventilation in spontaneously breathing patients. When the~     mechanical ventilatory assist is synchronized to the patient's inspiratory effort, both the~     patient and the mechanical ventilator will contribute to the lung-distending pressure,~     necessary to overcome inspiratory load and generate the tidal volume (Vt). Unfortunately,~     conventional modes of mechanical ventilation cannot quantify the impact of the ventilatory~     assist performed by the ventilator and the patient. Inadequate levels of assist are~     associated with adverse effects such as development of fatigue or patient-ventilator~     dissynchrony and diaphragm impairment, and over assist also lead to diaphragm atrophy and~     weaning delay.~      The newly introduced neurally adjusted ventilatory assist (NAVA) has made it possible to~     measure the neural activity of the respiratory centers (expressed by the diaphragm electrical~     activity, EAdi). EAdi is a validated variable to quantify the neural respiratory drive,~     little is known about its usefulness to evaluate the contribution of the patient's~     inspiratory muscle effort relative to that of the mechanical ventilator, which would be of~     crucial importance to appropriately titrate the level of assist.~      During NAVA, the patient's efficiency to transform neural effort (EAdi) into Vt, expressed as~     neuroventilatory efficiency (NVE), may be a useful predictor for determining the contribution~     of the patient and the ventilator to generate a breath.~   "
145440|NCT01663467|"~     The purpose of this study is to prove the efficacy of the internet and smartphone~     application-delivered tinnitus retraining therapy (TRT).~   "
145441|NCT01663454|"~     The purpose of this pilot study is to assist the preparation of a larger multi-center study.~     The main aim is to determine the feasibility of conducting computerized working memory~     training in a group of children with cerebral palsy.~   "
145442|NCT01663441|"~     This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the~     optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter~     randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of~     Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11~     (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240~     cancer patients undergoing chemotherapy.~   "
145443|NCT01663428|"~     This study evaluates the ability of a newly designed splint called Sup-ER Splint to improve~     the arm function and anatomy of children with birth related brachial plexus injuries.~   "
145444|NCT01663415|"~     The purpose of this study is to investigate radiographic progression-free survival (PFS) of~     enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant~     prostate cancer who have symptomatic disease.~   "
145445|NCT01663402|"~     Primary Objective:~      To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events~     (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction~     (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in~     patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to~     randomization and are treated with evidence-based medical and dietary management of~     dyslipidemia.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD~          event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic~          stroke, all cause mortality).~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the effect of alirocumab on lipid parameters.~   "
145446|NCT01663389|"~     This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study.~     This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion,~     and pharmacokinetics of GSK1322322 in 6 healthy adult male subjects through the sampling of~     blood, urine, and feces.~      Each subject will participate in the study for approximately 7 to 8 weeks i.e., 30 day~     screening period, two dosing periods (approximately 8 days each) and a follow up visit.~      The subjects will be admitted to the clinical unit on Day 1 of the first treatment period and~     remain in the unit for up to approximately 16 days through the end of the second treatment~     period.~      On Day 1 of Period 1, each subject will receive 14C radiolabeled GSK1322322 as a single~     therapeutic intravenous (IV) dose (1000 milligrams [mg]). When the total radioactivity is <1%~     of the administered dose in all subjects, Period 2 dosing will begin (approximately 8 days~     after the IV dose). On Day 1 of Period 2, each subject will receive single therapeutic oral~     solution dose (1200 mg). Blood, urine, bile and fecal samples will be collected during both~     the periods. The subject may be discharged from the unit as early as Day 8 of Period 2.~     Subjects will visit the study unit for the follow-up visit 7 to 10 days following discharge~     from the unit.~   "
145447|NCT01663376|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     critical limb ischemia~   "
145448|NCT01663363|"~     The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and~     effective for the correction of myopic refractive errors.~   "
145449|NCT01663350|"~     This is a prospective, multi‐center observational study designed to compare the test results~     of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening~     for fetal chromosome abnormalities in 'all-risk' pregnancies.~   "
145450|NCT01663337|"~     The broad, long-term objective of the current research is to improve treatment outcomes for~     individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and~     dependence (AUD).~      The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and~     cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP)~     treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes.~      The study will randomize 235 PTSD/AUD participants recruited from the VA and from the~     community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the~     AO condition will be re-randomized after the treatment phase to either RP or CPT. Individuals~     will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and 12-months~     post-treatment and will monitor symptoms daily throughout treatment.~   "
145451|NCT01663324|"~     Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory~     neural pathways contributing to the perception of phantom sounds.~   "
145453|NCT01663298|"~     Periodontal wound healing is a complex multifactorial process that involves interactions~     among various cells, growth factors, hormones and extracellular matrices. Although still~     poorly understood, these interactions trigger a series of events that lead to new tissue~     formation. One growth factor that plays an important role in wound healing is fibroblast~     growth factor 2 (FGF2). Many animal and human studies have shown this protein is effective in~     periodontal regeneration. Recently, epigenetic modifications, such as DNA methylation, have~     been associated with changes in patterns of gene expression. Preliminary data suggests that~     FGF2 gene may be differentially methylated in periodontal tissues. Aberrant gene promoter~     methylation in smokers and diabetics has also been reported in many studies. However, the~     role of DNA methylation in wound healing has not yet been investigated.~      The investigators hypothesize that the methylation status of FGF2 gene can affect the levels~     of FGF2 secreted during wound healing phase after dental implant surgery. The investigators~     also hypothesize there exists a difference in methylation levels of FGF2 gene in healthy,~     smoking and diabetic patients that can interfere with wound healing. The investigators seek~     to determine whether DNA methylation plays a role in wound healing and whether the~     methylation level of FGF2 gene varies among healthy, smoking and diabetic patients.~   "
145454|NCT01663285|"~     The main purpose of this study is to look at the cancer-free survival at two years of~     subjects with high risk upper tract urothelial cancer when treated with the combination of~     two chemotherapy drugs called Gemcitabine and Cisplatin followed by surgery to remove the~     kidney, all or part of the ureter (ureters are tubes made of smooth muscle fibers that propel~     urine from the kidneys to the urinary bladder), and a cuff of bladder where the ureter drains~     into the bladder. Other purposes of the study include looking at the safety of Gemcitabine~     and Cisplatin before surgery for this type of cancer, time to recurrence of cancer, and~     overall survival.~      Exploratory integrative tumor sequencing:~      The purpose of this part of the study is to test deoxyribonucleic acid (DNA) and ribonucleic~     acid (RNA) in various types of samples (tissue and blood) to detect different types of cancer~     genetic changes in upper tract urothelial cancer (UTUC) to help develop future studies in~     UTUC. DNA and RNA contain key instructions for cell function and help determine the~     characteristics of each individual such as hair, eye, and skin color, height, susceptibility~     to diseases, and other characteristics.~   "
145455|NCT01663272|"~     Gemcitabine is considered one of the standard drugs for advanced pancreatic cancer and is~     approved by the FDA to treat it. Cabozantinib is a new drug that has demonstrated~     effectiveness against pancreatic cancer in laboratory experiments, especially when given with~     gemcitabine. Initial studies with cabozantinib in pancreatic cancer have shown some activity~     against the disease. The purpose of this study is to determine the safest and highest dose of~     cabozantinib that can be given together with standard doses of gemcitabine in patients with~     pancreatic cancer. This study will determine the safety and tolerability of this two drug~     combination.~   "
145456|NCT01663259|"~     Taking into account the excellent prognosis of patients with HPV-positive oropharyngeal~     cancer with < 10 pack-year smoking, the investigators hypothesize that reducing the intensity~     of therapy for these patients will reduce treatment sequelae, notably long-term dysphagia,~     without affecting their cure rates. The main Aim is to assess whether reducing treatment~     intensity, by replacing concurrent chemotherapy with cetuximab, will indeed achieve improved~     long-term toxicity.~      The primary objectives include the following: to confirm that reducing treatment intensity in~     patients with HPV-related oropharyngeal cancer and < 10 pack-year smoking history by~     replacing concurrent chemotherapy with concurrent cetuximab, does not significantly increase~     the proportion of patients whose tumors recur, compared to our previous experience in similar~     patients receiving chemo-RT and to compare the toxicity in patients receiving cetuximab-RT to~     similar patients treated with 7 weeks of chemotherapy concurrent with RT (standard therapy)~     in UMCC 2-21.~   "
145457|NCT01663246|"~     The investigators are conducting research about oral health and saliva to find out more about~     the impact of radiation therapy on the oral health of patients.~      In order to better understand the role of saliva in maintaining oral health in these~     patients, the investigators will be collecting, storing, and analyzing the quality of saliva,~     including the protein content, collected from patients following radiation therapy as well as~     saliva collected from normal healthy adults.~   "
145458|NCT01663233|"~     This study will assess whether LCZ696 when used in combination with amlodipine will provide~     greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not~     adequately responsive to amlodipine therapy.~   "
145459|NCT01663220|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
145460|NCT01663207|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
145461|NCT01663194|"~     Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with~     adverse outcomes among patients with coronary artery disease, its role during the acute phase~     of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. This~     study sought to investigate the association of the pre-procedural N/L ratio within-hospital~     and long-term outcomes among STEMI patients undergoing primary percutaneous coronary~     intervention (PCI).~   "
145491|NCT01662804|"~     The purpose of this study is to find out if humanized 3F8 (Hu3F8) when combined with~     interleukin-2 (rIL2) is safe for treating neuroblastoma and other cancers. A phase 1 study~     means the investigators are trying to find out what side effects happen when higher and~     higher doses of a drug are used.~      The investigators want to find out what effects, good and/or bad, Hu3F8 combined with rIL2~     has on cancer. The amount of Hu3F8 that patients gets will depend on when they start~     treatment on this study. The amount of rIL2 will be the same for all patients. The~     investigators also want to find out more about how Hu3F8 works and how effective it is in~     attacking the disease when combined with rIL2.~   "
145503|NCT01662648|"~     The purpose of this study is to explore the efficacy of flexibly dosed paliperidone~     extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms~     of emotional instability, detachment from reality, often with delusions and hallucinations,~     and withdrawal into the self) who were previously unsuccessfully treated with other oral~     antipsychotics.~   "
145462|NCT01663181|"~     At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled~     for outpatient cystoscopy or urodynamic testing will be asked to participate in the study.~     Patients will be called one day after the examination and will be asked about pain and their~     general state of health.~      The purpose of this study it to investigate pain perception in urogynecologic patients during~     outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The~     investigators will also investigate the difference between anticipated and actual pain~     perception. The investigators will test the null hypothesis that there is no difference in~     patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary~     hypothesis will be that there is no difference between patients´ anticipated amount of pain~     and the actually experienced pain during cystoscopy and urodynamic testing.~      According to power calculation, a sample size of 52 patients per group will be needed to~     detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant~     difference - with 95% power and a two-sided significance level of 0.05.~      Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy~     and the participation in another clinical study at the same time.~   "
145463|NCT01663168|"~     - Background and study aims?~      Some of the drugs used to treat HIV (anti-retrovirals, or ARVs) can affect the blood levels~     of other drugs used to treat TB - called a drug-drug interaction. The main drug used in~     second-line therapy, Aluvia (lopinavir/ritonavir), is one of the drugs that has this effect.~     This is why people on second-line ARVs usually cannot use one of the main TB drugs,~     rifampicin, and instead will be prescribed a slightly different drug called rifabutin,~     which is less affected by these drug-drug interactions. Although blood levels of rifabutin~     are not as badly affected by Aluvia as blood levels of rifampicin, rifabutin levels in the~     blood are still increased a lot by taking Aluvia at the same time. This could lead to higher~     levels of side-effects because there is more drug in the body. So in the past doctors have~     suggested that instead of taking rifabutin every day with Aluvia, it should only be taken~     three times a week, on Mondays, Wednesdays and Fridays. However, in the last 2 years, new~     studies have suggested that this three times a week regimen might not be enough and that it~     may not completely cure TB. So the purpose of this study is to find out whether taking~     rifabutin every day with Aluvia really does lead to more side-effects, and whether taking~     rifabutin three times a week with Aluvia really does lead to much lower levels of rifabutin~     in the blood.~      - Who can participate?~      This substudy is specifically for people who are already taking anti-TB drugs in EARNEST, or~     who need to start anti-TB drugs whilst they are in the EARNEST trial.~      - What does the study involve?~      Participants will be selected (by chance, chosen by a computer) to one of the following two~     rifabutin groups:~      Group 1: Rifabutin (150 mg) taken three times a week on Monday/Wednesday/Friday Group 2:~     Rifabutin (150 mg) taken every day On these days, one capsule of rifabutin (150 mg) should be~     taken in the morning by mouth.~      Participants will be asked to attend clinic 2 and 12 weeks after entering the sub-study then~     every 6 weeks until the end of their TB treatment, and then return to their usual EARNEST~     follow-up schedule. This is roughly the same visit schedule for people with TB who are~     usually seen more frequently than those without TB, whether or not the patients join this~     sub-study. The 2 week visit is specifically so the investigators can make sure participants~     are doing OK on rifabutin and to check carefully that they don't have any side-effects. At~     all these visits (including the day when participants enroll into the substudy) the~     investigators will take an extra 10 ml (two teaspoons) of blood to do laboratory tests for~     side-effects of rifabutin, and to measure the levels of rifabutin and other ARVs in the blood~     - these are called pharmacokinetic or PK studies. On the day of these visits,~     participants should not take their dose of rifabutin until after this blood draw, so the~     investigators can measure the lowest amount of drug likely in their blood. Instead,~     participants should bring the rifabutin dose to clinic, so that they can take it straight~     after the blood draw. At the visit 12 weeks after starting rifabutin, participants will need~     to stay in clinic for a second blood draw of ~3 ml (half a teaspoon) around 4 hours after~     they take the rifabutin dose immediately after the first blood draw. We use this second~     sample to see how quickly rifabutin enters the blood. At this special visit the investigators~     will make sure participants are first seen as early as possible, so they don't have to stay~     any longer than necessary for the second blood draw to be taken 4 hours later. After~     participants have completed their TB treatment they will stay in EARNEST until the end of the~     trial (144 weeks on second-line therapy).~      - What are the possible benefits and risks of participating?~      If participants are allocated to Group 1 (150 mg rifabutin three times a week), there is a~     risk that they may have lower levels of rifabutin in your blood and this may be less~     effective at treating the TB. However, participants should have fewer side-effects. In~     contrast, if participants are allocated to Group 2 (150 mg rifabutin daily), here is a risk~     that they may get more side-effects, but the levels of rifabutin in the blood should be more~     than high enough to have a good chance of curing the TB. Having blood taken may cause some~     discomfort and/or bruising in some people. It is currently impossible to know which rifabutin~     regimen would be best and participants may find in years to come that they may or may not~     have received the best treatment.~        -  Where is the study run from?~           9 EARNEST sites in Uganda as follows: JCRC Kampala, IDI, San Raphael of St Francis~          Hospital (Nsambya), JCRC Mbarara, JCRC Mbale, JCRC Kabale, JCRC Kakira, JCRC Gulu~        -  When is study starting and how long is it expected to run?~      Start 05/03/2012 finish on 31/01/2014~      - Who is funding the study? Abbott~   "
145464|NCT01663155|"~     The investigators would like to see if lung cancer screening with chest x-rays,computer aided~     detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more~     responsive to treatment. The investigators would also like to see if early detection will~     reduce the incidence of symptomatic advanced lung cancer compared to no screening in former~     and current smokers with or without a family history of lung cancer who are 40-75 years old.~   "
145465|NCT01663142|"~     Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood.~     This disease, due to its morbidity and mortality, poses a significant public health problem~     in France. Apart from the involvement of bacterial factors and those involving the~     permeability of the epithelial barrier, it is now well recognized that several factors are~     associated with genetic predisposition in some of these patients. Among these factors, the~     Nod2 mutations were first identified. Studies concerning the presence of these mutations and~     the severity of disease results were sometimes conflicting. Very recently, new interesting~     mutations in genes involved in autophagy were found with greater frequency in patients with~     Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been particularly~     shown on large patient cohorts,the IRGM polymorphism was associated with a progressive~     disease, with histological severity scores. One of the severity criteria of Crohn's disease~     is the early recurrence observed in some patients after surgical resection of the injured~     segment. Predictive factors for such recurrence after surgery are not known or not.~   "
145466|NCT01663129|"~     To determine the magnitude and rate of bone mass deficits following initiation of~     glucocorticoid therapy for the treatment of pediatric leukemia, rheumatic conditions and~     nephrotic syndrome, we propose a 6 year, prospective study in 12 academic, tertiary care~     centres across Canada.~      The investigators hypothesize that glucocorticoid-treated children with leukemia, rheumatic~     conditions and nephrotic syndrome will fail to accrue bone mass at a normal rate, and that~     deficits in mineral accrual will occur in a glucocorticoid dose- and duration-dependent~     fashion. We also hypothesize that the fracture incidence will increase with concomitant~     reductions in bone mass.~   "
145467|NCT01663116|"~     Phase Ib/IIa clinical trial of a new medicinal product of the somatic cell therapy class~     (eASCs). This study is designed as a multicenter, single blind, fixed dose escalation, with~     three treatment groups, controlled with placebo (randomization 3:1) whose target population~     are patients with rheumatoid arthritis refractory to at least two biologic.~   "
145468|NCT01663103|"~     Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic~     kidney disease (CKD); however, this increased risk is only partially explained by traditional~     cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a key mechanism~     contributing to vascular dysfunction (i.e., large elastic artery stiffening and endothelial~     dysfunction). Inhibiting inflammation improves vascular dysfunction in other populations~     characterized by chronic inflammation. However, it is currently unknown if reducing~     inflammation with an interleukin-1 (IL-1) blocker enhances vascular function in CKD patients.~     Aim 1 will assess the efficacy of IL-1 blocking with rilonacept for treating vascular~     dysfunction in patients with stage III or IV CKD (estimated glomerular filtration rate 15-60~     mL/min/1.73 m2). Aim 2 will determine if blocking IL-1 with rilonacept also reduces~     inflammation and oxidative stress. These studies could shift clinical practice guidelines by~     establishing a novel therapy for reducing CVD risk in CKD patients not requiring chronic~     hemodialysis.~   "
145469|NCT01663090|"~     This research study is a pilot study to evaluate a new contrast agent, ferumoxytol, for the~     purpose of imaging lymph node metastases in patients with soft tissue sarcoma. This contrast~     agent is an investigational drug. Investigational means that the drug is still being~     studied and that research doctors are trying to find out more about it. It also means that~     the FDA has not approved ferumoxytol for this use. This drug has been used to image adults~     with other forms of cancer, however, it has only been used to image a small number of~     pediatric patients. Ferumoxytol has never been used to image sarcoma.~   "
145492|NCT01662791|"~     The potential role of small bowel bacterial overgrowth (SBBO) in weight loss occurring in~     patients with Parkinson's Disease (PD) has not previously been examined. Our hypothesis was~     that SBBO is an important contributor to the development of weight loss in individuals with~     PD. The investigators proposed to 1) examine the role of SBBO in weight loss occurring in~     patients with PD and 2) determine the response to its treatment with a poorly absorbed~     antibiotic. The investigators performed a prospective, observational case-control study (Part~     1) with an open-label therapeutic component (Part 2). Cases were defined as those PD patients~     who experienced significant weight loss while Controls were defined as those PD patients who~     did not experience significant weight loss.~   "
145493|NCT01662778|"~     The objective here is to determine that the efficiency of inhaled drug delivery can be~     improved by using a fine mist cloud of drug particles (as opposed to a coarse mist cloud of~     drug particles). This information will be valuable in designing new inhalers in order to~     improve their beneficial effects and reduce their side effects, by using the least possible~     drug dose to achieve a good patient response.~   "
145470|NCT01663077|"~     Approximately 30-60% of all schizophrenia patients who fail to respond to typical~     antipsychotics may respond to Clozapine. Clozapine has long been considered the gold~     standard within the atypical neuroleptic spectrum, backed by years of clinical experience~     and research, but uncertainties remain in some aspects of this drug. One such question is the~     link between dose, blood levels and patient clinical response. The Clozapine therapeutic~     plasma levels range between 250 - 450 ng/mL creating difficulties in using these results in~     routine clinical practice. Approximately 30% - 51% of treatment-resistant schizophrenia~     patients do not fully respond to Clozapine, a poorly understood phenomenon. Factors relevant~     to Clozapine-resistance include co-morbidity, drug misuse, poor adherence, inadequate~     duration of treatment and inadequate dose/plasma-levels. Pharmacogenetic factors such as~     different polymorphisms in involved genes may play a role. Pharmacodynamic and genetic data~     appear important in determining the clinical response to Clozapine. Clozapine-treated~     patients possessing different 3A4 polymorphisms, may respond differently as compared to other~     patients having normal 3A4 alleles. Recently, the CYP2D6 has also been involved in this drug~     metabolic pathway. Population pharmacokinetics of clozapine evaluated with the nonparametric~     maximum likelihood method. This pharmacogenetic explanation/hypothesis may explain Clozapine-~     resistance in schizophrenics.~      The high variability in plasma levels requires a large study in order to be able to determine~     correlation between clinical efficacy and plasma levels and genotyping. A preliminary study~     will enable power analysis and adequate determination of sample size.~   "
145471|NCT01663064|"~     The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory~     Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of~     abdominal aortic aneurysms.~   "
145472|NCT01663051|"~     This prospective, non-randomized, multi-center study is intended to evaluate the Zilver®~     Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.~   "
145473|NCT01663038|"~     The purpose of this study is to compare pharmacokinetics between fixed-dose combination and~     separate combination of clopidogrel 75mg/aspirin 100mg.~   "
145474|NCT01663025|"~     This randomised controlled trial aims to compare the effectiveness of hand reflexology~     received during office based vein surgery, under local anaesthetic on patient's reports of~     pain and anxiety, compared to usual standard care.~   "
145475|NCT01663012|"~     High Grade Gliomas, including anaplastic astrocytomas, anaplastic oligodendrogliomas and~     glioblastomas (GBM), are the most common and most aggressive primary brain tumors. Prognosis~     for patients with high-grade gliomas remains poor. The estimated median survival for patients~     with GBM is between 12 to 18 months. Recurrence after initial therapy with temozolomide and~     radiation is nearly universal. Since May 2009, the majority of patients in the US with an~     initial recurrence of high-grade glioma receive bevacizumab, a monoclonal antibody against~     vascular endothelial growth factor (VEGF), which is thought to prevent angiogenesis in these~     highly vascular tumors. BEV has response rates from 32-62% and has improved overall median~     survival in patients with recurrent high-grade gliomas1. However, the response is short~     lived, and nearly 100% of patients eventually progress despite bevacizumab. No~     chemotherapeutic agent administered following progression through bevacizumab has made a~     significant impact on survival. Patients progress to death within 1-5 months after resistance~     develops. Therefore, patients with high-grade gliomas who have progressed through bevacizumab~     represent a population in dire need of a feasible and tolerable treatment.~      NKTR-102 is a topoisomerase I inhibitor polymer conjugate that was engineered by attaching~     irinotecan molecules to a polyethylene glycol (PEG) polymer using a biodegradable linker.~     Irinotecan released from NKTR-102 following administration is further metabolized to the~     active metabolite, 7-ethyl-10-hydroxy-camptothecin (SN38), that causes DNA damage through~     inhibition of topoisomerase. The goal in designing NKTR-102 was to attenuate or eliminate~     some of the limiting side effects of irinotecan while improving efficacy by modifying the~     distribution of the agent within the body. The size and structure of NKTR-102 results in~     marked alteration in pharmacokinetic (PK) profile for the SN38 derived from NKTR-102 compared~     to that following irinotecan: the maximal plasma concentration (Cmax) is reduced 5- to~     10-fold and the half-life (t1/2 ) of SN38 is increased from 2 days to approximately 50 days.~     This altered profile leads to constant exposure of the tumor to the active drug. In addition,~     the large NKTR-102 molecule does not freely pass out of intact vasculature, which may account~     for relatively higher concentrations of the compound and the active metabolites in tumor~     tissues in in vivo models, where the local vasculature may be relatively more permeable. A~     145 mg/m2 dose of NKTR-102, the dose intended for use in this phase II clinical trial (and~     being used in the phase III clinical program), results in approximately the same plasma~     exposure to SN38 as a 350 mg/m2 dose of irinotecan, but exposure is protracted, resulting in~     continuous exposure between dosing cycles and lower Cmax. NKTR-102 was therefore developed as~     a new chemotherapeutic agent that may improve the clinical outcomes of patients.~   "
145476|NCT01662999|"~     The purpose of this study is to evaluate whether the pharmacokinetics (body~     concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when~     they are administered together~   "
145477|NCT01662986|"~     A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess~     the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in~     Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an~     acute exacerbation (Hospital Discharge Study 2)~   "
145478|NCT01662973|"~     Primary biliary cirrhosis (PBC) is a slowly progressive disease that causes substantial loss~     of intrahepatic bile ducts, ultimately resulting in cholestasis, advanced fibrosis,~     cirrhosis, liver failure and even hepatocellular carcinoma. Histologically, the disease is~     characterized by chronic portal inflammation with infiltration, destruction and loss of the~     epithelial cells in the small-sized and medium-sized bile ducts. Currently, Ursodeoxycholic~     acid (UDCA) in a dose of 13-15mg/kg/day is recommended as therapeutic drugs for PBC by AASLD~     and is approved for this indication by the U.S. Food and Drug Administration (FDA). Treatment~     with UDCA may delay disease progression and prolong survival free of liver transplantation.~     However, one out of three patients does not adequately respond to UDCA therapy and many need~     additional medical therapy or liver transplantation, or both. UC-MSC has been application for~     the treatment of several severe autoimmune diseases, such as immune thrombocytopenia,~     systemic lupus erythematosus, and therapy-resistant rheumatoid arthritis. In this study, the~     safety and efficacy of UC-MSC transplantation for PBC patients will be evaluated.~   "
145479|NCT01662960|"~     The purpose of the study is to determine whether an existing treatment for problems that~     participants have with making movements after a stroke can be performed at home.~   "
145480|NCT01662947|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the efficiency of device.~        2. Test methods and procedures: Clinical test in two positions: Seated and Supine.~        3. DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.~        4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and~          range: 0-300 mmHg.~        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Meet the requirements of SP10.~   "
145481|NCT01662934|"~     The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine~     could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.~   "
145482|NCT01662921|"~     We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting~     insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with~     gestational diabetes mellitus.~   "
145483|NCT01662908|"~     Assess the relative change in thrombus volume as determined by two assessments (Baseline and~     Day 14-21) with magnetic resonance venography (MRV) in subjects with deep-vein thrombosis~     (DVT) treated with either an edoxaban monotherapy regimen or a low molecular weight (LMW)~     heparin/warfarin regimen.~   "
145484|NCT01662895|"~     The main purpose of this study is to determine whether treatment with deferoxamine mesylate~     is of sufficient promise to improve outcome before pursuing a larger clinical trial to~     examine its effectiveness as a treatment for brain hemorrhage.~   "
145485|NCT01662882|"~     Evaluate florbetapir (18F) positron emission tomography (PET) imaging for distinguishing~     Japanese healthy control subjects, from Japanese subjects with Alzheimer's disease (AD) or~     Mild cognitive impairment (MCI).~   "
145494|NCT01662765|"~     The aim of the study was to compare the results of conservative and surgical treatment, to~     create an algorithm for the management of the disease, and gain more information about the~     etiology, pathogenesis, and course of the disease. The investigators hypothesise that~     surgical treatment of UPS will be better than conservative management in terms of recurrence~     rate, healing time, patient comfort and satisfaction, and cost effectiveness.~   "
145495|NCT01662752|"~     The main objective of this study is to determine whether the first (sentinel) lymph nodes in~     the drainage pathway of colonic tumour can be detected at the time of surgery using a new~     technique. The detection method is to inject a fluorescent dye (indocyanine green) adjacent~     to the tumour. The dye will then be seen as it fluoresces in the light form the near infrared~     spectrum that can be used at the time of the laparoscopic (keyhole) surgery. An endoscope is~     placed in the colon (colonoscopy) during surgery and the tracer fluorescent agent is injected~     around the tumour. The mesentery in which the lymph nodes draining the tumour are located~     will then be examined by laparoscopy as it is expected that fluorescence will be identified~     within approximately 5 minutes of the injection. The first lymph node or nodes that take up~     the fluorescent dye will then be marked by placing a clip or a stitch by them. After the~     surgery has been completed and colon removed all lymph nodes can be examined microscopically~     by the pathologist, paying a particular attention to whether any tumour cells are present in~     the sentinel lymph nodes and whether the presence or the absence of tumour cells in that node~     accurately reflects the tumour status of the rest of the specimen.~      If this pilot demonstrates that sentinel lymph nodes can be reliably detected, we have~     developed a technique which allows us to remove a small area (less than 5 cm) of the colon.~     Using this procedure should decrease complications following traditional surgery. We however~     also need a method that allows accurate assessment of the lymph nodes draining the tumour.~     This pilot trial will examine our ability to detect such 'sentinel' lymph nodes so that we~     can use their status (positive for cancer cells or negative) to determine whether a smaller~     operation such as full thickness localised excision is adequate treatment for the patient and~     that they can avoid a larger operation.~   "
145496|NCT01662739|"~     Gastric cancer remains one of the leading causes of cancer-related deaths worldwide. There is~     difference between different countries in the world in the incidence and outcome. Also Italy~     on its inside shows a variability between regions and Lombardy hold the most incidence and~     mortality Italian rate, with the province of Cremona as one of the leading area with its~     gastric cancer mortality rate. (http://www.aslcremona.it/html/atlante/introduzione.htm).~     Tumor specialized registry can be viewed as one of the main strategies for studying and~     monitoring the impact of an important cancer diagnosis. In addition the information obtained~     from it can be translated into preventive measures and health surveillance that might lead to~     a better control of this tumor in a province with a so high mortality rate. Project purpose~     is to define the incidence of gastric cancer in the province of Cremona and the correlation~     with environmental, familiar, genetic and social factors; to adopt prevention strategies to~     reduce the impact of the disease and to create a gastric cancer bio-bank, including blood and~     tissue samples, for collaborative research projects regarding molecular and cellular aspects~     of gastric cancer.~   "
145497|NCT01662726|"~     This study is investigating the effects of a new hormone treatment for breast cancer called~     Irosustat. Seventy percent of breast cancers in post-menopausal wome rely on oestrogen to~     grow therefore are likely to respond to hormone therapy. Irosustat blocks a different pathway~     of steroid synthesis to Aromatase, reducing in this way oestrogen levels in the body. As less~     oestrogen reaches the breast cancer, it grows more slowly or stops growing altogether.~      IPET will recruit postmenopausal women with early, hormone sensitive, treatment naive breast~     cancer will receive 40mg of Irosustat once daily for 2 weeks. The effects of Irosustat on~     breast cancer will be evaluated by PET scans (Positron Emission Tomography) using a~     radioactive substance called FLT as a tracer. The scans will be performed in a PET-CT scanner~     which combines a PET scan and a CT scan (Computer Tomography) into one scan. This type of~     scan can show how body tissues are working, as well as what they look like. FLT-PET scans~     will be performed before and following treatment with Irosustat. As cancer cells grow faster~     than the normal cells around them, they will take up more of the radioactive substance, and~     so stand out clearly on the scan. If Irosustat is slowing down the cancer growth, the cancer~     will take up less of the tracer.~      Blood samples will be taken at regular intervals to assess what the new drug does to the body~     and the safety and tolerability of Irosustat will be assessed. The study incorporates~     translation aspects/endpoints which are based on the collection of tumour biopsies before and~     after treatment with Irosustat although the later biopsy is not mandatory.~   "
145498|NCT01662713|"~     The purpose of this research study is to find out if a non-invasive imaging device called~     Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels~     that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details~     of your skin without needing to use any invasive techniques such as surgery or biopsy.~   "
145499|NCT01662700|"~     In Thailand, the proportion of P.vivax infection has now been increasing and is equal to~     Plasmodium falciparum since 1998. The incidence of P.vivax has recently been reported as 20~     per 1000 population per year. Unlike Plasmodium falciparum, P.vivax infection rarely develops~     into complicated malaria and death is unusual. However, P.vivax has a dormant stage (the~     hypnozoite) that persists in the human liver and may cause relapse weeks, months, or even~     years later. Therefore, P.vivax infection is considered to have greater impact on morbidity~     than mortality, resulting in significant social and economic burden. Moreover, it is very~     difficult to control P.vivax transmission, because gametocytes appear almost simultaneously~     with schizonts.~      Radical treatment of the infection, therefore, normally consists of a blood schizontocidal~     course of chloroquine and a course primaquine for the elimination of the hypnozoites as~     anti-relapse therapy. In Thailand, chloroquine and primaquine have remained the mainstay~     chemotherapeutics for the treatment of P.vivax for more than 60 years and resistance has not~     yet been reported . The relapse rates at day 28 are about 50% without primaquine therapy and~     about 20% with standard primaquine therapy. Relapse has not been observed among patients~     receiving high dose primaquine therapy (30 mg daily for 14 days).~      Since January 2007, the evidence of reduced susceptibility of Plasmodium falciparum to~     artemisinins in Western Cambodia at Thai-Cambodia border was first presented and confirmed in~     a subsequent detailed pharmacokinetic-pharmacodynamic study. Nevertheless, a trend of gradual~     decline of in vitro sensitivity to chloroquine has been documented in some areas of the~     country, particularly Thai-Myanmar border. There has been no clinical-parasitological~     evidence of chloroquine resistant P.vivax in Thai-Cambodia border, Thailand.~      The objectives of the present study are to assess in vivo efficacy of first line regimen of~     chloroquine given with primaquine, and in vitro susceptibility of P.vivax isolates in areas~     along Thai-Cambodia border, Thailand.~   "
145500|NCT01662687|"~     Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to~     demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared~     with the intravenous and oral Granisetron in the prevention of CINV associated with~     moderately emetogenic Chemotherapy.~      Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for 1-4~     days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy. Eligible~     patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2~     days prior to ME chemotherapy).~        -  Sancuso patch~        -  Kytril inj.+Kytril tab.~      The patch will be applied 2days (48-24h) prior to first daily dose of the moderately~     emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed~     daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be~     collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up until~     14 days after the final dose of IP. Serious adverse events will be followed-up until they are~     resolved, stable or until the patient is lost to follow-up.~   "
145501|NCT01662674|"~     This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of~     the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison~     to each component administered in healthy male volunteers.~   "
145504|NCT01662635|"~     Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is~     critically important to select those patients who are more likely to have the ALK mutation.~     Clinical characteristics of patients with mutations in the target gene should also be known,~     so that the incidence of a given target mutation is established in a specific population.~     There is not incidence known in Mexican population, but it is believed it is greater.~   "
145505|NCT01662622|"~     Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to~     investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC~     of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)~     in middle aged subjects.~   "
145506|NCT01662609|"~     The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early~     stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the~     development of pancreatic cancer. Endoscopic refers to the use of an instrument called an~     endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound~     refers to an imaging technique that uses sound waves to produce pictures. EUS in this~     research study is a method of combining endoscopy and ultrasound imaging to obtain high~     quality images of the pancreas.~   "
145507|NCT01662596|"~     The purpose of the study is to estimate the rate of risk factors for appearance of disease or~     fetal malformations in a population who turn to hospital Hillel Yaffe and examine whether~     there is a difference in the rate of early testing for diseases or birth defects in the~     fetus.~      Understanding the population and its risk factors, will allow specific reference to these~     risk factors to lowering them to eventually reduce the rate of congenital malformations in~     this population.~   "
145508|NCT01662583|"~     Influenza remains a potentially significant and largely preventable source of morbidity and~     mortality, yet vaccine coverage is low. Young children are at particular risk for~     underimmunization because they may need to receive 2 doses in a current season. Even among~     those young children that initiate vaccination, only 40% receive the important second dose,~     yet one dose does not confer adequate protection. Low-income, urban children may be at~     particular risk of not receiving two doses. While traditional mail and phone immunization~     reminders notifying families that a vaccine is due have had limited efficacy in low-income,~     urban populations, we have demonstrated the success of using text messages. Comparing the~     effectiveness of different forms of reminders on receipt of this critical second dose of~     influenza vaccine has not been studied. Besides failure to remember to return for subsequent~     doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health~     literacy regarding influenza vaccination, particularly associated with understanding the need~     for a second dose since not all children require it. Text messaging offers the ability to~     combine health literacy promoting information and reminders in a scalable, efficient manner~     for populations at high risk for underimmunization, limited health literacy, and influenza~     spread. Therefore, the purpose of this study is to determine whether the provision of~     interactive vaccine health literacy-promoting information in text message vaccine reminders~     improves receipt and timeliness of the second dose of influenza vaccine within a season for~     underserved children in need of two doses.~   "
145509|NCT01662570|"~     The rise in childhood overweightness and concomitant increase in chronic disease risk~     warrants exploration into the effectiveness of interventions targeting the eating and~     activity habits of overweight youth. This research study developed and tested a Beverage~     Choice and Lifestyle Modification (BCLM) intervention for 4 to 8 year old children who are~     at-risk for being overweight or are overweight and who consume large amounts of sugar~     sweetened beverages and juice. The overall study objectives were to test the acceptability~     and effectiveness of the BCLM intervention for improving the weight status, energy (kcal)~     intake, beverage selections and beverage preferences of children in targeted age and BMI~     group. The investigators hypothesized that those children randomized to the BCLM group will~     show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and~     energy intake than those assigned to our Nutrition Education (NE) group.~   "
145510|NCT01662557|"~     Childhood overweight continues to increase at an alarming rate and the need exists to find~     effective, accessible intervention strategies to prevent and treat children who are at risk~     for being overweight or are already overweight. The primary care setting provides an~     attractive option for families wishing to receive treatment, yet little is known about the~     feasibility, acceptance or efficacy of this intervention setting. The purpose of this study~     was to test two different primary care treatments that were intended to increase fruit and~     vegetable intake, increase physical activity, and reduce sedentary activity in children ages~     4-8, who are overweight or at risk for becoming overweight. Both treatments involved the~     child and a parent/caregiver and both were conducted over a four month period. The~     parent/child dyads were selected from the pool of families who receive their primary care~     within the Geisinger Medical Center geographic area and who have been identified by their~     pediatrician as being overweight or at risk for becoming overweight (BMI >85th percentile for~     age). One group received weekly mailings which focused on healthy eating, promotion of fruit~     and vegetable intake and physical activity, and methods to reduce TV viewing time. The second~     group received a group-based intervention at one of the Geisinger Pediatric Clinic sites~     using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV~     viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid~     profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as~     treatment satisfaction and acceptance. The investigators hypothesized that children who~     receive Family Behavior Modification (FBM) in the primary care setting will show greater~     reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference,~     and that children receiving FBM will show greater improvements in dietary intake, increased~     physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.~   "
145511|NCT01662544|"~     Bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and~     children. Multiple supportive therapies have been tried in infants with bronchiolitis~     including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date~     supportive therapy with oxygen is the only proven therapy to decrease respiratory distress in~     infants with bronchiolitis, with hypertonic saline showing a borderline statistically~     significant improvement. This prospective, randomized study will compare CSS and PEWS scores~     on infants who receive oxygen by standard flow nasal cannula and to those who receive oxygen~     via Humidified High-Flow Nasal Cannula (HHFNC). The results will help determine if infants~     with viral bronchiolitis who receive humidified high flow nasal cannula oxygen therapy have~     improved Clinical Severity Score (CSS) and Pediatric Early Warning System (PEWS) scores and~     ultimately decreased lengths of admissions when compared to patients treated with nasal~     cannula oxygen therapy with/without bronchodilator therapy.~      Hypothesis Heated Humidified High-flow Nasal Cannula Delivery of Oxygen decreases respiratory~     distress as measured by pediatric CSS and PEWS when compared with routine nasal cannula~     oxygen delivery in infants with bronchiolitis.~   "
145516|NCT01662466|"~     The purpose of this study is to determine the effect of treatment with trans-dermal~     testosterone cream compared to placebo on measures of ovarian reserve, oocyte and embryo~     quality, and pregnancy rates among women with evidence of diminished ovarian reserve that~     have persistently low serum testosterone and free testosterone after completing six previous~     weeks of DHEA supplementation.~   "
145517|NCT01662453|"~     The main purpose of this study is to develop a North American registry for SUDEP cases;~     requesting family members of epilepsy patients who died suddenly of unclear causes (SUDEP) to~     contact the study team. The family members who decide to participate in the study will be~     asked to complete a brief telephone interview about their loved one's epilepsy and seizure~     history and the circumstances of his or her death. If the death has occurred within the past~     24 hours, and the family is willing to consider donating tissue to the study, the subject~     will be transferred to the Autism Tissue Program, and the remainder of the phone interview~     will be conducted at a later time.~      In addition to the phone interview, the family will be asked to provide access to the~     deceased's medical records. Any costs involved in obtaining medical records will be covered~     by the study, and all medical information will remain completely confidential.~   "
145518|NCT01662440|"~     Establish non-inferiority of the immune response and evaluate the safety and tolerability of~     Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to~     either of 2 schedules for preexposure prophylaxis.~   "
145519|NCT01662427|"~     To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in~     Parkinson's disease patients and caregivers.~   "
145520|NCT01662414|"~     This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo~     (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease.~      The principal objective is to evaluate the changes in biomarkers of oxidative stress~     and,plasma amino acids, as well as improvement of clinical symptoms and brain function~   "
145521|NCT01662401|"~     After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in~     the postoperative period. As a routine part of the procedure, surgeons inject local~     anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most~     children will still require additional pain medications after surgery. The purpose of the~     study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal~     nerve) will give better pain relief, decreasing pain medication requirements and increasing~     comfort during the postoperative period.~   "
145522|NCT01662388|"~     Several techniques have been advocated to get good contacts in dental composite restorations~     including interdental separation ring. The investigators study focuses on using separation~     ring with circumferential matrix band instead of a sectional band. Moreover, the~     investigators have attempted to study proximal tightness and proximal contours of composite~     restoration as separate variables~   "
145523|NCT01662375|"~     The Maastricht III procedure consists of performing organ donation in patients in whom~     cardiac arrest is consecutive to a decision to withdraw life support.This MIII procedure is~     not applied in France, in contrast with other industrialized countries.The proposed study is~     designed to evaluate the feasibility of adapting the MIII procedure in France by conducting a~     single-centre, prospective study. Within the population of patients admitted to the Nantes~     University Hospital Medical Intensive Care Unit for whom a clinical team meeting decides to~     withdraw life support, the investigators want to determine the delay elapsed between the life~     support withdrawing and the onset of spontaneous cardiac arrest, that is without any~     intentional procedure susceptible of precipitate the death onset. The cardiovascular state~     observed during this period and its duration determine the viability of the organs harvested.~     The invetigators also want to determine the incidence of refusal of organ donation that would~     be formulated by the family and/or loved ones if they had been asked to consent to an MIII~     procedure at the time of announcement of the clinical team's decision to withdraw life~     support.Anonymous data concerning the patient will be collected by using a predefined grid,~     completed partly by the medical team in charge of the patient and partly by a CRA from data~     in the patient's medical file.The study with families and/or loved ones will be conducted in~     the context of the CHU de NANTES Clinical Ethics Unit and according to this unit's~     methodology. The main working tool used by the Clinical Ethics Unit consists of interviews~     between its members and the various parties participating in elaboration of a decision (in~     this case, the virtual possibility of organ donation according to the MIII procedure).The~     purpose of this interview is to stimulate reflection on issues not previously considered, by~     introducing new elements and by using, as a tool, the principles of biomedical ethics~     developed by Beauchamps and Childress. This study should be able to determine which types of~     patients could be concerned by the Maastricht III procedure. The expected results should help~     to define the quantitative impact and feasibility of this procedure on organ donation and~     could be used to subsequently propose a larger-scale multicenter prospective study.~   "
145524|NCT01662362|"~     The study is conducted to meet an FDA post market commitment to collect and report data on~     the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are~     FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA~     Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified~     donor specimens will be tested with ABBOTT ESA Chagas assay.~   "
145525|NCT01662349|"~     The purpose of this study is to evaluate the safety of treating human skin with atmospheric~     plasma and get an initial evaluation of the efficacy of this treatment for acne.~   "
145526|NCT01662336|"~     The overall purpose of the study was to describe the real-life adherence, effectiveness and~     safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency~     virus (HIV)-positive patients who were receiving treatment with lopinavir / ritonavir (LPV/r;~     Kaletra®) in Canada.~   "
145527|NCT01662323|"~     The purpose of this study is to determine whether it is possible to improve the care of~     general practitioners for patients with heart failure. The investigators try to reach that~     goal by training the GP's for 90 minutes in uptitrating the recommended medication according~     the guidelines. After 6 month the investigators ask the patients to fill out a questionary.~     The investigators ask them about their quality of live.~   "
145528|NCT01662310|"~     The purpose of this study is to evaluate the efficacy, tolerability and safety of~     paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in~     the prevention of relapse in schizophrenia participants.~   "
145578|NCT01661647|"~     Problem : Precise and personalized 3D knee kinematic assessment during physical and daily~     life activities is a challenge; therefore, it was never performed on an important number of~     individuals. However, a better understanding of 3D knee kinematics during such activities~     would allow a better understanding of this often injured joint.~      Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation~     device that can be used under local anesthesiaallows for precise and reproducible assessment~     of 3D knee kinematics during physical and daily life activities.~      Objectives :~        -  To study human knee 3D kinematics during dynamic activities using a novel minimally~          invasive measuring system~        -  Investigate the correlations between standard clinical knee laxity tests and measured 3D~          knee kinematics during dynamic activities~   "
145529|NCT01662297|"~     This is a pilot comparative effectiveness study designed to determine whether trazodone is as~     effective as quetiapine for treatment of insomnia in veterans with a history of addiction and~     mental health issues. The study will have two concurrent phases (parts); first an~     acceptability determination phase, to determine whether and why (or why not) veterans already~     taking quetiapine are willing to try an alternative to quetiapine for sleep; and second, a~     randomized trial phase which will test whether staying on quetiapine has any advantage over~     switching to trazodone. The purpose of the first phase will be a) to document the proportions~     of patients and physicians who are willing to agree to such a switch, b) to characterize~     sociodemographic and clinical characteristics of potentially eligible subjects associated~     with a willingness to switch from quetiapine to trazodone and c) to record the reasons given~     why patients and their prescribers are (or are not) willing to accept a switch from~     quetiapine to trazodone. It will also function to provide some educational background to~     patients and a reminder to providers about the potential severe side-effects of quetiapine,~     and will thus facilitate clinical informed consent for the clinical trial phase of the study.~     Completion of the first part of the study will also serve as the screening component for part~     II. Part II includes, first, obtaining written informed consent from eligible subjects, and~     then randomly assigning them to continue quetiapine or to be switched to trazodone in~     open-label real world fashion for the duration of 4 weeks, followed by another four weeks~     of open, non-randomized follow- up. The purpose of the second part of the study is to~     determine if trazodone is an adequate substitute for quetiapine, primarily in terms of~     treating insomnia. The investigators hypothesize that trazodone will not be inferior to~     quetiapine in maintaining good quality of sleep measured by sleep scales (i.e., scores will~     not significantly worsen once switched). This study is open to Veterans in the VA system~     only. Eligible subjects must have a history of dual diagnosis (i.e., a history of addiction~     and mental illness).~   "
145530|NCT01662284|"~     The purpose of this study is to assess the use of investigational compound 124I-NM404 for~     accurate detection and characterization of a wide variety of solid primary and metastatic~     malignancies anywhere in the body.~   "
145531|NCT01662271|"~     The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life,~     psychosocial situation, and health of the affected youth. However, as few of these~     adolescents seek medical care, little is known about the longitudinal course of adolescent~     extreme obesity.~      In this study, the investigators aim to provide structured care for adolescents with obesity~     and extreme obesity over a prolonged period of time, and to gain information on the course of~     obesity and the success of different treatment options. The study is a subproject of the~     Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects~     of structured care, short: Youth with Extreme obesity Study (YES), which aims at improving~     the medical care and social support structures for youth with obesity and extreme obesity in~     Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years~     (initially up to 21 years) are eligible to participate. Participants will have a physical~     check-up every 12 months (initially every 6 months), complete questionnaires on their health,~     socioeconomic status and wellbeing, and are offered blood test and diagnostic procedures to~     assess comorbidities. Participants are offered support and guidance for social and vocational~     integration. The study will evaluate and inform treatment and support options for adolescents~     with extreme obesity.~   "
145532|NCT01662258|"~     This is a prospective interventional study to assess laboratory testing which will identify~     the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent~     selection for patients with community acquired-pneumonia (CAP).~      Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with~     respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted~     narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to~     Empiric therapy in patients with viral pneumonia~   "
145533|NCT01662232|"~     Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired~     endothelial function (assessed as flow-mediated dilation) represents an early marker for~     later cardiovascular events. Epidemiological and experimental studies suggest that~     consumption of tea is associated with lower progression of atherosclerosis and reduced~     cardiovascular mortality.~      Tea contains high amounts of polyphenols with important biological activities. The green tea~     catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound~     in vitro. However, little is known about its contribution to beneficial effects of tea in~     vivo.~      In this crossover study the impact of a single dose of EGCG applied in different forms (green~     tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in~     healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to~     appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in~     cardiovascular protective effects of green tea in vivo. The outcomes will provide insights~     about the role of EGCG in different application forms to improvements of endothelial function~     in humans.~   "
145534|NCT01662219|"~     Pain and discomfort after anterior cervical spine surgery is difficult to quantify and quoted~     as moderate in severity, often needing oral opioid analgesics. In addition, these patients~     are more prone for postoperative respiratory complication due to airway edema secondary to~     surgical retraction or wound hematoma. Opioid analgesics provide good pain control but~     postoperative nausea and vomiting and respiratory depression are undesirable in these~     patients who are at risk for postoperative wound hematoma and airway edema The use of~     multimodal analgesia is rapidly becoming the 'standard of care' for preventing pain after~     ambulatory procedures at most surgery centers throughout the world . The purpose of this~     study is to determine whether superficial cervical plexus block will improve the~     postoperative quality of recovery as measured by Quality of Recovery 40 questionnaire~     (QoR-40) in patients undergoing elective anterior cervical discectomy and fusion.~   "
145535|NCT01662206|"~     The purpose of this study is to determine whether healthy older adults, aged 65 to 80 years,~     consuming a probiotic each day for three weeks will have improved immune strength and~     digestive health. It is hypothesized that older adults consuming the probiotics will see a~     shift in their microbiota towards the healthy bacteria resulting in a greater proportion of~     immune cells, decreased inflammation, and better digestive health.~   "
145579|NCT01661634|"~     The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous~     (IV) ularitide infusion on the clinical status and outcome of patients with acute~     decompensated heart failure (ADHF).~   "
145580|NCT01661621|"~     This study is a prospective randomized, open label, controlled, double arm, post-marketing~     study to compare the treatment efficacy of first-line antimuscarinics and α-blockers~     monotherapy for men with moderate to severe lower urinary tract symptoms (LUTS)~     (International Prostate Symptom Score (IPSS-T) ≥8) and IPSS voiding-to-storage subscore ratio~     (IPSS-V/S) ≤1.~   "
145581|NCT01661608|"~     The primary objective is to collect data on the use of the EndoSurgical Operating System~     (EOS) for gastric tissue approximation during primary gastric restrictive procedures.~   "
145536|NCT01662193|"~     The epidemic of type 2 diabetes is an enormous public health problem in all parts of the~     world, with 366 million cases by 2030. Chronic inflammation has been postulated to play a~     role in the pathogenesis of type 2 diabetes. High levels of adiponectin and inflammatory~     biomarkers are known as a new risk factor for diabetes. There is accumulating evidence~     suggesting that altered vitamin D and calcium homeostasis affect the development of type 2~     diabetes, but it is still unclear whether that effects are through reducing the level of~     adipocytokines and inflammatory biomarkers or not. This study has been designed to evaluate~     the effects of vitamin D and calcium supplementations alone and in combination on~     inflammatory biomarkers and adypocytokines in type 2 diabetic patients.~      This study is a single masked, controlled randomized trial with period of 8 weeks. 120~     diabetic patients who met the inclusion criteria will enroll in this study. Subjects will~     randomly assign in to four groups. Randomization will be achieved by permuted blocks with~     stratification by age, sex, BMI, type of diabetes and dose of medication. Group1 will receive~     50000 IU of vitamin D3 per week plus calcium placebo, group2 will received 1000 mg of calcium~     carbonate per day plus vitamin D placebo, group 3 will receive 50000 IU of vitamin D3 plus~     100 of mg calcium carbonate per day and group four will receive calcium and vitamin D~     placebos. Total cholesterol, HDL, LDL, serum triglyceride, serum glucose, serum insulin,~     HbA1C, leptin, adiponectin and inflammatory biomarkers such as TNF-alpha, IL-6 and high~     sensitivity C reactive protein (hs-CRP) will be determine by taking blood samples at the~     baseline and at the end of intervention. Systolic and diastolic blood pressure and~     anthropometric measurements (height, weight, hip and waist circumferences) will be measured~     at the baseline and after 8 weeks of intervention. 3 dietary records and 3 physical activity~     records will be taken at 2,4 and 6 week of intervention to make sure that all subjects~     maintain their usual diet and physical activity during intervention.~   "
145537|NCT01662180|"~     This large prospective multi-center cohort study aims to identify patient's characteristics~     that significantly influence ovarian response to mild stimulation with a fixed dose of 75 IU~     recombinant FSH.~   "
145538|NCT01662167|"~     The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.~   "
145539|NCT01662154|"~     Anesthetizing nerves in the extremities is an effective way to freeze an area in preparation~     for surgery. The doctor injects local anesthetic in an appropriate area, interrupting signals~     from nerves in that area that control movement and sensation. Depending on how much~     anesthetic is injected, the doctor can impair both movement and sensation or sensation alone.~     Currently, there are a few methods used to determine how much sensation a patient has in an~     area, such as testing the patient's response to a pinprick or cold sensation on the skin.~     Unfortunately, these methods are subjective and don't always give an accurate measurement of~     how extensive the block is. For this reason, a more accurate and objective method of~     assessing nerve blocks is needed. We wish to perform a study to test two nerve stimulation~     devices to compare their ability to give adequate measurements of nerve activity before and~     after local anesthesia. If we find that a common nerve stimulator can consistently give~     accurate readings of nerve activity, anesthesiologists may be able to use this device to~     determine how well a nerve block is working and adjust the patient's anesthesia accordingly.~   "
145540|NCT01662141|"~     The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper~     management of severely hemodynamic compromised patients. A new ultrasound dilution method~     (COstatus) for cardiac output measurement has been developed.~   "
145541|NCT01662128|"~     Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with~     more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy~     of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental~     group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21~     days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And~     the control group will not receive any adjuvant therapy.Finally the investigators will assess~     the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using~     medications.~   "
145542|NCT01662115|"~     The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative~     period influences surgical outcome in patients undergoing colorectal surgery.~   "
145543|NCT01662102|"~     The purpose of this study is to evaluate the effect of consolidation treatment Zevalin®~     versus maintenance treatment with Rituxan® on progression-free survival (PFS) following~     response induction with chemotherapy plus rituximab in previously untreated patients with~     follicular lymphoma.~   "
145544|NCT01662089|"~     Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient.~     But the type of patient, efficacy, and side effect in detail of zinc supplement are not well~     characterized. The purpose of this study is to determine efficacy and side effect of chelated~     zinc in FPHL who using 5%minoxidil solution.~   "
145545|NCT01662076|"~     Cancer-related fatigue has been described as a subjective feeling of physical, emotional,~     and/or cognitive tiredness. Fatigue is frequently identified as one of the most troublesome~     symptoms in pediatric cancer patients. Fatigue affects children with cancer throughout the~     trajectory of their disease. Treatment interventions for cancer-related fatigue have been~     largely unsuccessful. Homeopathy involves treatment of patients with diluted natural~     substances aimed at stimulating the body's healing system. In the efficacy trial literature,~     individualized homeopathy shows the most promise over other forms of homeopathic~     intervention. Individualized homeopathic treatment involves a unique yet established method~     of case taking. During the consultation, the homeopath asks a series of broad questions to~     elicit subjective symptoms related to the patient's disease, their medical history, as well~     as particular characteristics (physical or psychological) related to the individual. This~     study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat~     their fatigue. This study hypothesizes that homeopathic treatment will effectively treat~     fatigue.~   "
145546|NCT01662063|"~     This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in~     participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414)~     or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants~     will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96~     weeks.~   "
145582|NCT01661595|"~     This study is funded by the Moody Endowment. In this project, we will investigate the~     potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle~     anabolism, muscle strength, physical function, and body composition in older individuals.~     Further, we will determine whether augmentation of NO-mediated signaling reduces fatigue and~     fatigability.~   "
145773|NCT01659073|"~     The investigators propose that Arterial Spin Labelling Functional Magnetic Imaging will be~     able to capture functional changes associated with caloric vestibular stimulation and better~     delineate the etiology of the pain augmentation that has been documented with this~     intervention.~   "
145547|NCT01662050|"~     A phase 2 study of standard R‐BAC (rituximab 375 mg/m2, bendamustine 70 mg/m2, ara‐c 800~     mg/m2) has been recently ultimated at the Vicenza Hematology Department involving several~     regional centers on both untreated and previously treated patients with Mantle Cell Lymphoma~     (MCL). An interim analysis conducted on 30 patients showed that rituximab + bendamustine +~     ara‐c combination had very good clinical activity, but a quite relevant hematological~     toxicity, especially in previously treated and older patients (Visco C, ICML 2011 Lugano~     Conference, Poster 236).~      Objectives:~      The primary objective is to determine the activity (complete remission rate according to~     Cheson 2007 criteria) and safety of age‐adjusted Rituximab‐Bendamustine‐Cytarabine (RBAC500)~     regimen at the end of treatment in older untreated patients with MCL.~      The secondary objectives are to determine:~        -  The rate of molecular response (characterized by labs of the FIL)~        -  The progression‐free survival (PFS)~        -  The overall survival (OS)~        -  The duration of responses (DOR)~        -  The rate of patients that complete the expected treatment schedule (6 courses)~        -  The rate of patients that are subject to dose reductions or delays~   "
145548|NCT01662037|"~     Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to~     investigate if Bosentan therapy can modify the outcome of children with functional single~     ventricle.~   "
145549|NCT01662024|"~     Gastric restriction is an important principle of both roux-en-Y gastric bypass and~     laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing~     System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric~     size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of~     this system has the potential to reduce the complications associated with current surgical~     approaches while effecting the desired gastric restriction. The primary objective is to~     collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery,~     Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive~     procedures.~   "
145550|NCT01662011|"~     Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that~     delivers ventilatory assist in proportion to neural effort. It was a controlled randomized~     single-center prospective study in order to explore the efficacy of this new mode of~     mechanical ventilation after corrective open-heart surgery for congenital heart disease.~   "
145551|NCT01661998|"~     The purpose of this study is to evaluate the relationship of A) The distal fusion level B)~     The total length of fusion and the post-operative range of motion in the unfused vertebral~     segments below the fusion in patients with Adolescent Idiopathic Scoliosis.~   "
145552|NCT01661985|"~     The purpose of this on-going study is to study the number of days after antibiotic treatment~     has commenced (due to infection caused by the sexually transmitted bacteria Chlamydia~     trachomatis (CT) and Mycoplasma genitalium(Mg)) it takes to be cured i.e to get a negative~     test result. The specimens are analyzed on first-catch-urine (men) or patient's self-obtained~     vaginal sample with quantitive nucleic acid amplification test(NAAT). A secondary aim is to~     detect macrolide resistant Mg-strains and study whether there are any emerging macrolide~     resistant Mg-strains after treatment with azithromycin. A third aim is to study whether the~     participating subjects are adherent to the study protocol meaning 12 samples taken during a~     period of four weeks.~   "
145553|NCT01661972|"~     The Primary Phase I objectives are to determine the recommended phase II dose for the~     capecitabine and aflibercept doublet combination; and to describe any dose limiting and~     non-dose limiting toxicities. The Phase II Primary objective is to determine progression free~     survival associated with this regimen. The Phase II secondary objectives are to determine~     response rate associated with this regimen; to determine overall survival associated with~     this regimen; and to explore any correlation of clinical outcome with baseline and on~     treatment changes in blood-based angiogenesis biomarkers.~      This open-label, non-randomized phase I/II trial is designed to assess the safety,~     tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic~     colorectal cancer.~   "
145554|NCT01661959|"~     The purpose of this study is to analyze the long-term outcomes of surgical treatment of~     idiopathic scoliosis of all curve patterns treated by either anterior or posterior~     procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic~     scoliosis.~   "
145555|NCT01661946|"~     Currently, two similar medications are available for injection into the eye to treat a~     variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab~     (Avastin). They both have a similar mechanism of action and work equally well, however only~     ranibizumab was designed for use in the eye. It is significantly more expensive per injection~     than bevacizumab (by a factor of roughly 40x).~      In published studies trends have been noted towards an increased rate of systemic side~     effects such as heart attacks and strokes. This is presumably due to absorption of the~     drug(s) from the eye into the bloodstream, however this has never been shown before. The~     purpose of the investigators study was to compare the bloodstream levels of bevacizumab and~     ranibizumab at various time points after injection into the eye. This required the creation~     of a sophisticated assay to measure blood levels of the drugs.~   "
145556|NCT01661933|"~     We have established that the hookworm Necator americanus (Na) dramatically alters the local~     and systemic immune landscape of the infected human host. Consistent with the principle of~     desensitisation, diet managed celiac disease subjects previously infected by us with Na will~     be invited to receive small incremental doses of gluten as pasta (3-25 mm straw of spaghetti)~     over 16 weeks. Each participant will then be carefully re-assessed to determine if it is~     appropriate to undertake a 12-week gluten challenge.~   "
145590|NCT01661491|"~     Cystic Fibrosis (CF) is a fatal, recessive genetic disorder characterized by progressive~     inflammation and lung damage. It is unclear whether current treatment strategies, which focus~     on detection and eradication of pathogenic microorganisms in the lung, are the best way to~     prevent the initiation of early inflammation and lung damage. This study asks how early~     acquisition of microbial flora occurs in infants with CF and healthy baby controls, and~     whether this process initiates or influences early inflammation and clinical disease~     progression in CF.~   "
145591|NCT01661478|"~     The purpose of this quality improvement research project is to briefly survey attitudes among~     healthcare providers toward patients with substance use disorders before and after substance~     abuse counselors are placed in the Emergency Room.~   "
145557|NCT01661920|"~     The duration of antibiotic treatment in community-acquired pneumonia (CAP) lasts about 9-10~     days, and is determined empirically. The last North American guideline for CAP recommends~     using clinical stability criteria as a reference to establish the duration of antibiotic~     treatment, which would result in about 5 days of antibiotic use for the majority of pneumonia~     cases. In order to validate this proposal we propose to carry out a randomized multicenter~     double-blind (until the 5th day) clinical trial with adult CAP patients admitted to 4~     hospitals in Euskadi. A control group (with routine treatment) will be compared with an~     intervention group (antibiotic treatment for at least 5 days, which will be interrupted if~     temperature is =< 37,8ºC for at least 48 hours and no more than one sign of clinical~     instability is assessed), with regards to: mortality at 15 days, clinical recovery by days 10~     and 30, clinical improvement after days 5 and 10 as evaluated by PRO scales, duration of~     antibiotic treatment. A non-inferiority dichotomous sequential analysis will be performed~     (for mortality after 15 days, clinical recovery by day 10 and in follow-up at 30 days,~     clinical improvement after days 5 and 10, with PRO scales) as well as a superiority analysis~     for the duration of the antibiotic treatment. A total of 1100 patients will be recruited,~     following their signed consent, during the inclusion period (18 months). Stability criteria~     will be measured daily. The rest of the variables will be measured at admission and by~     telephone on days 10 and 30.~   "
145558|NCT01661907|"~     Postoperative delirium is a common complication in critically ill patients after surgery. Its~     occurrence is associated with worse outcomes of the patients. The pathophysiology of delirium~     remains poorly understood. A universal phenomenon is that delirium was frequently identified~     in elderly patients after major complicated surgery, but was rarely noted after minor~     ambulatory surgery (such as cataract surgery). This indicated that stress response produced~     by surgery might have an important role in the pathogenesis of delirium. It has been reported~     that, when compared with general anesthesia and postoperative intravenous analgesia,~     neuraxial anesthesia and analgesia reduced the occurrence of postoperative complications and~     mortality in high risk patients. Combined epidural-general anesthesia is frequently used in~     clinical practice. This anesthesia method provides advantages of both epidural and general~     anesthesia, i.e. it blocks the afferent pathway of nociceptive stimulus by neuraxial blockade~     during and after surgery, and allows patients to endure lengthy complicated operations~     without any awareness. The investigators hypothesize that combined epidural-general~     anesthesia and postoperative epidural analgesia can decrease the incidence of postoperative~     delirium and, thus, improve the prognosis of critically ill elderly patients undergoing major~     surgery. The purpose of this study is to compare the effects of combined epidural-general~     anesthesia/postoperative epidural analgesia and general anesthesia/postoperative intravenous~     analgesia on the incidence of postoperative delirium in elderly patients undergoing major~     surgery.~   "
145559|NCT01661894|"~     The primary objective is to examine the efficacy of 8-weeks of a locally developed~     brain-computer interface based system (BrainpalTM)intervention for improving attention and~     memory in normal elderly. We hypothesize that elderly who have completed the training program~     will have significant improvement in their attention and memory compared to the controls,~     based on the Repeatable Battery for the Assessment of Neuropsychological Status.~   "
145560|NCT01661881|"~     Mantle cell lymphoma (MCL) is not curable with conventional therapy. This study sought to~     improve upon standard of care in newly diagnosed, untreated MCL patients who were~     transplant-eligible using drugs already established as active in MCL. The combination of~     Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize~     pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with~     tolerable toxicity.~   "
145561|NCT01661868|"~     This research study is a way of gaining new knowledge about a drug called olaparib in women~     who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1)~     or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the~     exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from~     repairing their DNA. In this research study, we are looking to see how well the drug olaparib~     works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well~     as those who have received a prior PARP inhibitor and whose cancer has re-grown after~     receiving that PARP inhibitor.~   "
145562|NCT01661855|"~     This study will examine the potential efficacy and safety of riluzole for core and associated~     symptom domains of autism and will explore biological markers of safety and treatment~     response.~   "
145563|NCT01661842|"~     Autoimmune hepatitis (AIH) is characterized by chronic inflammation of the liver, interface~     hepatitis, hypergammaglobulinemia, and the presence of autoantibodies. Disease presentation~     is varied but typically is based on characteristic aminotransferase elevations, histological~     abnormalities, elevated levels of serum globulins, and the presence of one or more~     autoantibodies. Two types of juvenile AIH have been identified according to seropositivity~     for smooth muscle and /or antinuclear antibody (AIH type 1) or liver kidney microsomal~     antibody (AIH type 2). Standard therapy in clinic consists of a combination of~     corticosteroids and azathioprine, which displays the efficacy in 80% of patients. However, 7%~     of patients deteriorate despite compliance with the standard corticosteroid regiments~     (treatment failure),13% of patients improve but not to a degree that satisfies remission~     criteria (incomplete response), 13% of patients develop serious drug-induced complications,~     and 50%-86% of patients will relapse after drug withdrawal. These serious drawbacks~     counterbalance the benefits of conventional therapy, and they are compelling reasons to~     refine current treatment strategies and pursue alternative therapies. UC-MSC has been the~     application for the treatment of several severe autoimmune diseases, such as immune~     thrombocytopenia, systemic lupus erythematosus, and therapy-resistant rheumatoid arthritis.~     In this study, the safety and efficacy of UC-MSC transplantation for AIH patients will be~     evaluated.~   "
145564|NCT01661829|"~     In patients who underwent sphincter preserving surgery with toal mesorectal excision and~     diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators~     would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal~     function after stoma closure.~   "
145565|NCT01661816|"~     The study aims to analyse and decode interviews of patient with breast cancer, and then~     established according a multidimensional profile specific to the population and to create a~     questionnaire tha will allow a practical and qualitative evaluation of the quality of life.~   "
145568|NCT01661777|"~     The purpose of this study is to evaluate the benefit of treatment of refractory Eustachian~     tube dysfunction with standard treatment for endolymphatic hydrops. Eustachian tube~     dysfunction is a common diagnosis made in otolaryngology related to abnormal pressure~     equalization of the middle ear space related to a swollen, inflamed, or occluded Eustachian~     tube. The symptoms of this include perceived hearing loss, a feeling of fullness in the~     affected ear/ears, ear pain, ear popping, and occasionally imbalance. These symptoms overlap~     with a more rare and difficult to diagnose condition known as endolymphatic hydrops, or an~     overproduction to fluid in the inner ear. The treatment for these two conditions are distinct~     and traditionally, patients are treated for Eustachian tube dysfunction first as it is much~     more common and there are several treatments, namely nasal steroids, antihistamines, and~     pressure equalization tubes. For patients who do not improve with these treatments, they are~     often treated with diuretics and a low salt diet to treat for supposed endolymphatic hydrops.~     There has never been a study to investigate the utility of these treatments in patients with~     refractory Eustachian tube dysfunction. There is also reason to believe that chronic ETD with~     effusion can lead to both inner and middle ear dysfunction. Thus, this study aims to~     determine the benefit of standard endolymphatic hydrops treatment on patient with refractory~     Eustachian tube dysfunction symptoms in a prospective fashion.~      Hypothesis:~      Patients with refractory Eustachian tube dysfunction (patients with no or minimal symptom~     improvement despite nasal steroid and antihistamine treatment followed by myringotomy tube~     placement) have an element of endolymphatic hydrops and these patient's symptoms will improve~     with a low sodium diet and diuretic.~   "
145569|NCT01661764|"~     Colorectal cancer is the second leading cause of cancer-related death within the United~     States. Animal models and observational studies have suggested that marine-derived n-3~     polyunsaturated fatty acids [PUFA] such as eicosapentanoic acid [EPA] and docosahexanoic acid~     [DHA] may reduce the risk of colorectal cancer. In addition, it may be the relative~     proportion of n-3 to n-6 PUFAs that best determines the chemopreventive effects of fish oils.~     This ratio is important because the n-6 PUFA, arachidonic acid (ARA), is converted via the~     cyclo-oxygenase (COX) pathway to prostaglandin E2 (PGE2), an inflammatory eicosanoid~     overproduced in colorectal neoplasms while EPA is converted to the anti-inflammatory~     prostaglandin E3 (PGE3). While the ratio of n-6 to n-3 PUFAs can be altered through dietary~     changes, genetic factors may also influence this ratio. Recent genetic studies have~     demonstrated that much of the tissue levels of ARA is determined by differences in a gene~     called fatty acid desaturase 1 (FADS1). FADS1 is the rate-limiting enzyme in the conversion~     of linoleic acid, the most commonly consumed PUFA in the Western diet, to ARA, and one~     particular genetic variant caller rs174537 is associated with lower fatty acid desaturase~     activity and subsequently lower tissue levels of ARA.~      The study hypothesis is that individuals with genetically determined lower activity of FADS1~     will derive greater benefit from fish oil supplementation than individuals with higher FADS1~     activity because of lower tissue levels of ARA and subsequently a more favorable n-6 to n-3~     PUFA ratio. To test this hypothesis the investigators will recruit 150 participants with~     recently identified adenomatous polyps and conduct a 6-month double blind 3 X 2 factorial~     randomized controlled trial. The first factor will be FADS1 genotype (GG, GT, and TT) and the~     second factor will be fish oil supplementation (fish oil versus placebo). The primary outcome~     will be the change in rectal epithelial cell growth and cell death. Secondary outcomes will~     include rectal epithelial cell expression of genes important in PGE2 production, rectal cell~     production of PGE2 and PGE3, rectal mucosal tissue levels of fatty acids, and changes in~     biomarkers of inflammation (C-reactive protein), adipokines (leptin, adiponectin), and~     markers of insulin sensitivity.~      The specific aims include: 1) to determine the efficacy of fish oil supplements on rectal~     epithelial cell proliferation indexes and markers of rectal crypt apoptosis, and 2) to~     determine the effect of genetically-determined fatty acid desaturase 1 activity on fish oil~     supplementation for colorectal cancer chemoprevention. The investigators long-term objectives~     are to determine genetic factors that might influence the efficacy of fish oil~     supplementation in order to conduct a more definitive adenoma recurrence trial using~     marine-derived n-3 PUFAs. The investigators anticipate that fish oil will have~     anti-neoplastic effect and individuals with low FADS1 activity will have a greater response~     compared to individuals with high FADS1 activity~   "
145570|NCT01661751|"~     The clinical trial was designed to evaluate the safety and immunogenicity against Group~     ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of~     age and older.~   "
145571|NCT01661738|"~     The clinical trial was designed to evaluate the safety and immunogenicity against Group~     ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of~     age and older.~   "
145572|NCT01661725|"~     The clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal~     Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.~   "
145573|NCT01661712|"~     The aim of this randomized, double-blinded, sham-controlled cross-over trial is to~     demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the~     pharyngeal dilator muscles to reduce sleep-disordered breathing.~   "
145574|NCT01661699|"~     The purpose of this study is to check blood and urine levels to further define markers/tests~     in the blood and urine that would be useful in following patients with obstructive sleep~     apnea and then to see if by wearing CPAP every night, these markers can be reduced. This~     research is being done because currently there are no effective blood or urine markers to~     determine how well CPAP is working.~   "
145575|NCT01661686|"~     The purpose of this study is to determine whether fully covered or partially covered metal~     stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary~     outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a~     stent or tumour related cause in a 6-month follow-up~   "
145576|NCT01661673|"~     This study is being conducted to determine the safety, tolerability, pharmacokinetics, and~     effects of EVP-0962 on cerebral spinal fluid Amyloid concentrations in healthy subjects and~     in subjects with mild cognitive impairment or early Alzheimer's disease.~   "
145577|NCT01661660|"~     Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems,~     behavioural and psychological symptoms (BPSD), and an impairment of activities of daily~     living (IADL) are frequently encountered and usually show an impact on autonomy maintenance,~     prognostic and care during the prodromal and early stages of the disease.~      Such symptoms are noticeable before the diagnosis of dementia and their occurrences as well~     as their intensity increase with the evolution of the disease.~      Apathy, initially defined as a reduction of motivated behaviours, is the most frequently~     observed BPSD. Apathy is clinically defined by a significant reduction or complete loss of~     interest, initiative capacity and emotional blunting. Accordingly, apathy is characterized by~     diminished goal-directed cognitions and behaviours.~      Behavioural and psychological assessment relies essentially on neuropsychiatric scales. These~     are used to gather precise data regarding patient's clinical state from interviews with the~     patient, the career or from clinical impressions during the consultation. From their apparent~     simplicity they have made their way into daily clinical practices, yet neuropsychiatric~     scales are reportedly biased by the assessors' subjectivity.~      However, some tools whose allow simple, fast and objectively valid assessments are not widely~     used.~      Hence, the use of ICT such as actigraphy (wearable device assessing locomotion activities),~     automatized audio-video recognition and signal analysis from events, may be of interest in~     addition to current assessment methods.~      The aim of this study is to implement an objective assessment of goal directed activities and~     autonomy in an experimental design including predefined actions. The setting includes video~     cameras, microphones, actigraphic and Galvanic Skin Response sensors for recording and~     computer-based recognition of events using audio-video data, locomotion data and sinusal~     variability respectively as well as extracting biomarkers for supporting detection of~     dementia at early stages and supporting ongoing tracking of the dementia disease state. The~     following population will be included: patients with Mild Cognitive Impairment (n=50),~     patients with Alzheimer's disease (n=50) and control participants (n=50).~      This work will provide further objective information for clinical practitioner in order to~     detect behavioral disturbances such as apathy.~   "
145583|NCT01661582|"~     Exposure to particulate air pollution is associated with increases in cardiovascular~     mortality and morbidity. The pathophysiological mechanisms underlying this observation are~     emerging, and exposure to particulate air pollution has been shown to result in increases in~     blood pressure and arterial tone, impaired vascular function and an increased tendency for~     blood to clot as well as an increase in atherosclerotic plaque burden. Recent evidence from~     panel studies and controlled exposure studies have suggested an increase in myocardial~     ischaemia (a reduction in blood flow to the heart) following exposure. In this study we aim~     to investigate directly myocardial (heart) blood flow following exposure to diesel exhaust~     (as a model of urban air pollution) using CT/PET myocardial perfusion imaging in male~     patients with stable coronary disease and healthy male controls. We hypothesize that~     following exposure to dilute diesel exhaust:~        1. Myocardial blood flow will be reduced~        2. Coronary flow reserve will be impaired~        3. The magnitude of impairment will be higher in patients with coronary disease as compared~          to healthy controls~   "
145584|NCT01661569|"~     We propose a randomised controlled trial in a workplace setting to investigate whether a~     smartphone-delivered programme of mindfulness meditation influences psychological and~     biological indicators of well-being.~      We hypothesise that after 8 weeks participants who complete the meditation programme will~     show increases in psychological well-being and reduced activation of stress-related~     biological pathways.~   "
145585|NCT01661556|"~     Melasma is an acquired discoloration of the skin characterized by brown colour changes~     commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The~     control group will receive treatment with topical Hydroquinone (4%), and the other group~     topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for~     melasma patients. The estimated number of subjects to be recruited and randomized for the~     study is at least 30. The purpose of this study is determine if there is a difference in the~     effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be~     assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry~     and histological assessment will be also evaluated. Occurrence of adverse effects will also~     be recorded.~   "
145586|NCT01661543|"~     The purpose of this study is to compare how regularly eating (dried) beans or peas or rice~     (control) lowers blood lipids, particularly Low Density Lipoprotein cholesterol and total~     cholesterol, in mildly hypercholesterolemic men and women. The investigators hypothesize that~     regularly eating beans or peas will significantly improve blood lipid profiles in these~     people.~      Participants in this study will consume 1 study food item 5 out of 7 days a week containing~     beans or peas or rice for a total of 6 weeks. This study will benefit Canadian pulse growers~     by enhancing development of food products for human consumption and supporting marketing~     strategies to increase awareness that a diet rich in pulses can improve human health.~     Measuring changes in blood and urinary polyphenol levels will help to verify whether these~     compounds play a role in the beneficial actions of beans and peas and subsequently assist~     with the identification of the beneficial bean/pea components. This in turn, will enable crop~     breeders to select for plants that are rich in these compounds.~   "
145587|NCT01661530|"~     In the last forty years the prevalence of asthma has increased in westernised countries. We~     have hypothesised that this increase may be a consequence of changing diet. Several birth~     cohort studies have now reported an association between reduced maternal vitamin E intake~     during pregnancy and childhood asthma.~      However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy~     reduces the risk of childhood asthma. We are planning a large placebo controlled trial in~     pregnant women, to investigate whether optimisation of dietary vitamin E intake to the~     recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary~     intervention using vitamin E in its natural form of food is more likely to be successful and~     acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women~     can optimise their vitamin E intake using a personalised dietary plan with the help of a~     dietitian however this intervention was complex and could not be translated into everyday~     use. With commercial support we have developed a range of soups containing foods naturally~     rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of~     similar tasting and looking placebo soups has also been developed. In this study we will~     pilot a randomised controlled trial of the active and placebo soups to ascertain whether~     pregnant women are willing and able to optimise their vitamin E intake during pregnancy using~     the soups in order to reduce the risk of their child developing asthma. optimising maternal~     vitamin E intake during pregnancy.~   "
145588|NCT01661517|"~     This study will be a quality improvement project to review the effectiveness and barriers to~     effectiveness of a new clinical program in the emergency room to provide substance use~     screening followed by brief motivational interviewing and referral to treatment for patients~     who meet criteria for problem substance use. This study will consist of a chart review of the~     results of the screens performed by substance use counselors and correlating them to~     institutional variables such as wait time in the emergency room and length of stay as well as~     to patient variables obtained by chart review such as medical diagnosis and sociodemographic~     variables.~   "
145589|NCT01661504|"~     The overall goal of this proposed study is to develop the state of knowledge in the area of~     gender-based violence and reproductive health by conducting a randomized controlled trial to~     improve the health care provider's capacity to screen for intimate partner violence and to~     mitigate associated risk among women health clinic patrons of reproductive age (ages18-44)~     with recent experiences of physical or sexual partner violence in Mexico City and its~     surrounding area.~      The specific research objectives are as follows:~        1. To increase mid-level health care providers' capacity to identify Intimate Partner~          Violence (IPV) and assist women with risk mitigation~        2. Utilizing a randomized controlled trial, to assess the impact of an enhanced health care~          worker screening and counselling program on (a) past year severe IPV (sexual or~          physical), including severe IPV; (b) reproductive coercion (c) use of community-based~          resources and safety planning; and (d) quality of life; versus minimum standard of care~        3. To qualitatively examine which programmatic components may serve as mechanisms for~          observed changes stated in the second objective~        4. To synthesize study findings and a) create recommendations for clinic-based intervention~          programs to address IPV in low and middle income countries and b) disseminate~          information as reports, presentation, and peer-reviewed publications~   "
145592|NCT01661465|"~     To ensure consistent documentation of alcohol and substance use, the emergency medicine is~     initiating a new standard of care for substance use screening: the use of a brief~     self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed~     in triage. This questionnaire will allow emergency medicine patients presenting to the~     emergency room. This study will also review medical records after one year of the index~     emergency room visit to establish rates or re-presentation and hospitalization correlated~     with different substance use.~   "
145593|NCT01661452|"~     A survey (patient self-report) of patients presenting to UAB emergency room, outpatient~     trauma clinics and substance abuse center for symptoms of post-traumatic stress disorder and~     maladaptive coping responses after the widespread tornado disaster that occurred in Alabama~     in April 2011.~   "
145594|NCT01661439|"~     Preconceptional use of low molecular weight heparin (enoxaparin) and aspirin in patient with~     recurrent miscarriages with positive anti phospholipid antibodies increase the implantation~     rate and the duration of pregnancy with low complications to the mother and the baby.~   "
145595|NCT01661426|"~     The traditional weight loss diet recommended by health professionals has been a low-fat,~     high-carbohydrate, calorie restricted diet. This recommendation has been challenged by a~     number of alternative dietary strategies, particularly low-carbohydrate diets. In several~     recent weight loss studies insulin resistant adults had more success with low- vs.~     high-carbohydrate diets, in contrast to insulin sensitive adults who had either more success~     or comparable success with the low-fat diets. The investigators enrolled 61 people with a~     wide range of insulin sensitivity/resistance. After determining their insulin resistance~     status, the investigators will split them in the middle and randomly assign them to one of~     four groups for six months: (1) Low-Carbohydrate/Insulin Resistant (LC/IR); (2)~     Low-Carbohydrate/Insulin Sensitive (LC/IS); (3) Low-Fat/Insulin Resistant (LF/IR); and (4)~     Low-Fat/Insulin Sensitive (LF/IS) (15 people/group). After 6 months the participants will~     switch diet for the following 6 months, i.e. those randomized to the Low-Carbohydrate diet~     will switch to the Low-Fat diet and vice-versa. The primary outcome of this study is to~     determine whether weight loss success can be increased if one follows the dietary approach~     appropriately matched to their insulin resistance status. Secondary outcomes include fasting~     insulin, glucose, lipids, and fatty acid composition.~   "
145596|NCT01661413|"~     Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy.~     Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during~     treatment reported by paediatric cancer survivors. Complete prevention of both nausea and~     vomiting is the goal of anti-vomiting and nausea medications. It is important to understand~     whether or not certain chemotherapeutic treatments are more or less likely to cause these~     symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal~     methotrexate is an important part of chemotherapy for the prevention and treatment of central~     nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The~     likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and~     vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal~     methotrexate will cause nausea and vomiting will therefore be important to optimize treatment~     for these side-effects of chemotherapy. The primary aim of this prospective study is to~     evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric~     cancer patients.~   "
145597|NCT01661400|"~     The purpose of this research study is to determine whether taking either of two low dose~     drugs that would prevent new blood vessels from growing after stem cell transplant is~     feasible, and what the side effects of taking each of these drugs after autologous transplant~     might be. The reason the investigators are looking at these drugs is because one of the~     things that allows tumors to grow quickly is their ability to stimulate the growth of new~     blood vessels. By suppressing the growth of new blood vessels after stem cell transplant, the~     investigators hope to prevent the tumors from coming back or continuing to grow.~   "
145598|NCT01661387|"~     As a post-approval requirement of the European Medicines Agency, this European patient post~     authorization safety study is an observational study being conducted to monitor the safety of~     long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine~     clinical practice in patients with chronic adrenal insufficiency (primary or secondary).~   "
145599|NCT01661374|"~     In this study the investigators will collect mucus from mechanical ventilated patients and~     patients with COPD to study the effect of temperature and humidity, on the biophysical~     properties of the airway mucus. It is hypothesised that changes in inspired gas temperature~     and humidity (over time) may affect the biophysical properties of the airway mucus and reduce~     the airway's ability to clear mucus, resulting in deleterious clinical affects.~   "
145600|NCT01661361|"~     Recently, it was reported that when vancomycin levels are determined after port sampling,~     levels can be falsely increased potentially leading to wrong dose adjustments.~      The investigators conducted an in vitro experiment using several central venous port devices,~     in which different flushing techniques were evaluated yielding residual vancomycin levels of~     less than 0.5 mg/L.~      In this study, the investigators want to evaluate this flushing technique in vivo in 15~     patients admitted with catheter-related infection and treated with systemic vancomycin and~     vancomycin antibiotic lock.~      The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained~     via port sampling.~   "
145601|NCT01661348|"~     Aim 1: Assess the effectiveness of the Prevena Incision Management System in decreasing~     postoperative surgical site infections in the obese parturient undergoing non-emergent~     cesarean delivery.~      Aim 2: Assess patient satisfaction after using the Prevena Incision Management System~     following a non-emergent cesarean delivery.~      Our overall long term goal is to reduce morbidity and incidence of surgical site infection~     (SSI) in obese parturient who undergo non-emergent cesarean delivery.~   "
145602|NCT01661335|"~     The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the~     standard therapy will help children who receive chemotherapy to have less nausea and~     vomiting.~   "
145774|NCT01659060|"~     The purpose of this study is to to test the feasibility of design methods and procedures for~     later use on a larger scale and to examine the acute and chronic effect of consumption of~     flavanol-rich chocolate on endothelium function and blood pressure in healthy pregnant women.~   "
145603|NCT01661322|"~     The risk of recurrence is greatest immediately after stroke or Transient Ischaemic Attack~     (TIA). Existing prevention strategies (antithrombotic, lipid/blood pressure lowering,~     endarterectomy) reduce, not abolish, further events. Dual antiplatelet therapy - aspirin &~     clopidogrel (AC) for IHD, aspirin & dipyridamole (AD) for stroke, is superior to aspirin~     monotherapy. The investigators hypothesise that triple antiplatelet therapy (ACD) will be~     superior to AD in patients at high-risk of recurrence, providing bleeding does not become~     excessive.~      Design: TARDIS is a multicentre, parallel-group, prospective, randomised, open-label,~     blinded-endpoint, controlled trial. In the start-up phase, the investigators will assess over~     3 years the safety, tolerability and feasibility of intensive therapy (ACD) versus guideline~     therapy (AD) given for 1 month in 750 patients with acute stroke/TIA. The main phase will~     then assess the safety and efficacy of ACD in up to 3500 patients. The primary outcome is~     ordinal stroke (fatal/severe non-fatal/mild/TIA/none) at 90 days. Secondary outcomes include~     death, MI, vascular events, function, bleeding, serious adverse events; sub-studies will~     assess cerebral emboli and platelet function.~   "
145604|NCT01661309|"~     Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary~     animal produce, which can elevate homocysteine. There is strong evidence indicating that~     elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as~     primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant~     decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin~     B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.~   "
145605|NCT01661296|"~     Infections caused by the protozoan parasite Leishmania include cutaneous (CL), mucosal (ML)~     and visceral leishmaniasis (VL). Over 12 million people currently suffer from leishmaniasis,~     and approximately 2 million new cases occur annually, making it a major global health~     problem. CL CL caused by Leishmania tropica is endemic around the city of Bikaner in Thar~     Desert region of the State of Rajasthan . WHO recommends antimonials such as sodium~     stibogluconate (SSG) to treat CL. However, these drugs are toxic and have poor patient~     compliance as they require multiple intramuscular or intralesional injections for 3 weeks. In~     addition, the emergence of drug-resistant strains is rapidly increasing worldwide. We are~     interested in novel treatments for CL that are safe, easy to administer and effective in~     inducing long-term cure. Recently, radio-frequency-induced heat (RFH) therapy has been used~     to treat CL. This treatment involves the controlled and localized delivery of~     radiofrequencies into lesions for 30-60 seconds under local anesthesia. Several short-term~     follow-up (4-5 months) studies as well as one long-term follow-up (12 months) study involving~     US soldiers who were infected with L. major in Iraq found that RFH therapy was comparable, or~     even better, than systemic antimonials. However, more studies are needed to establish~     long-term efficacy of RFH therapy in treatment of CL caused by other Leishmania species that~     are difficult to treat with conventional drugs, and to determine the risk of disease~     recurrence if any in patients living in Leishmania endemic regions. The goal of this trial is~     to compare long term efficacy of RFH therapy in treatment of CL caused by L. tropica in~     patients residing in Leishmania-endemic regions of India.~   "
145606|NCT01661283|"~     To determine the clinical response rate of everolimus in combination with bevacizumab for~     patients with chemotherapy refractory sporadic or neurofibromatosis type 1 (NF1) associated~     malignant peripheral nerve sheath tumor (MPNST). To evaluate the toxicity and safety of~     everolimus in combination with bevacizumab in individuals with MPNST~   "
145607|NCT01661270|"~     Primary Objective:~      To evaluate the improvement in progression-free survival (PFS) of aflibercept versus placebo~     in participants with metastatic colorectal cancer treated with FOLFIRI as second-line~     treatment for metastatic disease.~      Secondary Objectives:~      To compare the overall survival (OS) in the 2 treatment arms. To compare the overall response~     rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To~     assess immunogenicity of intravenous (IV) aflibercept in selected centers.~   "
145608|NCT01661257|"~     This study investigated the expression of T-cell immunoglobulin- and mucin-domain-containing~     molecule 3 (TIM-3) in the colonic mucosa and/or the peripheral blood of children with Crohn's~     disease during anti TNF-α (infliximab) therapy.~   "
145609|NCT01661244|"~     RV568 is being developed as a possible treatment of smoking related lung disease (also known~     as Chronic Obstructive Pulmonary Disease - COPD).~      The main purpose of this study is to examine the safety and tolerability of a new inhaled~     formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and~     Part B. Part A (Cohorts 1, 2 & 3) will investigate 6 different dose levels of RV568 given as~     a single dose and Part B (Cohorts 4 & 5) will investigate 2 different dose levels of RV568~     given once a day for 14 days.~   "
145610|NCT01661231|"~     BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from~     BIOFLEX-I EU will be pooled with data in the IDE. The objective of this study is to~     separately demonstrate the clinical performance of BIOTRONIK's Astron and Pulsar-18 stents in~     the European arm of the BIOFLEX-I IDE (NCT01319812). The Pulsar-18 stent will be used for the~     treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA)~     or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of~     the common or external iliac artery lesions.~   "
145611|NCT01661218|"~     The investigators aim to determine the complications and risk factors related with~     peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer~     patients.~   "
145612|NCT01661205|"~     The purpose of this study is to assess the safety and technical feasibility of treating~     subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation~     in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar~     System, with mapping and additional lesion creation/ gap closure (as needed) provided by~     currently approved catheter technology, when the epicardial and endocardial phases are~     performed in a staged manner within 1-10 days apart, during the same hospitalization.~   "
145653|NCT01660672|"~     Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20%~     and leaving one third of survivors with long term neurologic and psychiatric sequelae.~     Seizures occur commonly with CM and are associated with an increased risk of death and~     neuropsychiatric disabilities. In this Malawi-based, dose- escalation, safety and feasibility~     study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for~     future efficacy studies aimed at improving seizure control and ultimately decreasing the~     neurologic morbidity of pediatric CM.~   "
145613|NCT01661192|"~     At a previous study the investigators have assessed the safety and efficacy of treatment with~     AAT(Alpha 1 Antitrypsin)in newly diagnosed type 1 diabetes subjects aiming at beta cells~     preservation .~      Since treatment with AAT is expected to be a chronic treatment; stopping treatment will~     probably result in eventual loss of the preserved beta-cell function. Indeed, other~     investigational drugs aiming at beta cells preservation have shown that patients who were~     initially treated and maintained their initial beta-cell function, required continuation of~     treatment or they lost the beta-cell function.~      Therefore, in this extension study, patients who were previously treated with AAT and~     maintained clinically significant beta-cell function are offered a continuation of treatment,~     since they are likely to benefit from use of the medication.~      The proposed study is aimed to assess the long term effect of AAT in subjects with type 1~     diabetes mellitus: safety and tolerability of treatment, and effect on beta-cell function.~      Subjects who have completed all visits of the 008 study will be offered to participate in the~     extension study.~      The study will be consist off two main arms as following:~      Arm 1: Subjects who maintained peak stimulated C-peptide secretion ≥ 0.2 nmol/L will continue~     treatment with AAT for up to 18 treatments according to the dosage group they were allocated~     to in the 008 study.~      Arm 2:~      Subjects who have not maintained peak stimulated C-peptide secretion ≥ 0.2nmol/L and subjects~     with peak stimulated C -peptide secretion ≥ 0.2 nmol/L who are reluctant to receive~     additional study drug.~      Clinical follow up for all subjects in both arms will be for 3 years~   "
145614|NCT01661179|"~     Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese~     Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma.~   "
145615|NCT01661166|"~     The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity~     (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and~     to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients.~     Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.~   "
145616|NCT01661153|"~     This prospective observational study will evaluate the use in clinical practice, efficacy and~     safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with~     HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up~     to 2.5 years.~   "
145617|NCT01661140|"~     This randomized, placebo-controlled, double-blind study will compare the safety and efficacy~     of tapering methotrexate (MTX) versus maintaining MTX dosage in patients with severe active~     rheumatoid arthritis and an inadequate response to disease-modifying antirheumatic drugs~     (DMARDs) initiated on treatment with tocilizumab. Participants will receive tocilizumab 8~     mg/kg intravenously every 4 weeks and MTX orally weekly throughout the study. At Week 24,~     participants achieving a good/moderate EULAR response will be randomized receiving the MTX~     Tapering arm or MTX Maintenance arm. Up to Week 56 participants will receive either tapering~     or stable dose MTX in combination with tocilizumab. From Week 56 to Week 72 participants will~     receive tocilizumab monotherapy.~   "
145618|NCT01661127|"~     Psoriasis is associated with increases in markers of inflammation in the skin and blood and~     increasingly is thought to be a systemic inflammatory disease and risk factor for incident~     diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death.~     Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial~     emotional impact on an individual, which is not necessarily related to the extent of skin~     disease.~      FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner~     that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that~     chronic disease such as end stage renal disease with depressive symptoms have decreased~     cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was~     designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of~     cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms~     in patients with psoriasis.~   "
145619|NCT01661114|"~     Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers~     leading to responses in a substantial minority and increasing survival. The use of the~     FOLFIRINOX regimen is limited by its' intensity and toxicity. Previous protocol and clinical~     experience within the University of Michigan Pancreatic Program leads to an expectation of~     tolerance and efficacy of the proposed regimen. Advantages of the proposed regimen relative~     to FOLFIRINOX include:~        1. Substitution of gemcitabine for irinotecan. Single agent activity of gemcitabine is at~          least as good as irinotecan (probably better, especially when delivered by FDR~          [fixed-dose rate] infusion) and gemcitabine is much better tolerated with less diarrhea,~          nausea/emesis, myelosuppression and alopecia.~        2. Deletion of leucovorin infusion and 5FU bolus injection will lessen myelosuppression,~          mucositis and diarrhea.~        3. Substitution of cisplatin for oxaliplatin will reduce cost of therapy and avoid cold~          aggravated dysesthesia.~      Presuming evidence of efficacy and confirmation of tolerance with the proposed regimen, the~     investigators believe this treatment may be more widely applicable to pancreatic-biliary~     cancer patients, including those with advanced disease as well as being considered for use in~     locally advanced and neo- and adjuvant settings.~   "
145620|NCT01661101|"~     Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying~     than those who do not. One in 10 patients with myocardial injury will die within 30 days of~     surgery. This risk of death exists up to one year after myocardial injury. There are~     currently no treatments or guidelines available for heart injury after surgery, but there is~     evidence that taking a blood-thinner can prevent some of the deaths, both in the short and~     long-term. The purpose of this trial is to test the effect of two drugs (dabigatran and~     omeprazole) that may prevent mortality, major cardiovascular complications and major upper~     gastrointestinal bleeding in patients who have had myocardial injury after noncardiac~     surgery.~   "
145621|NCT01661088|"~     The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination~     of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic~     disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to~     address local disease, will achieve a significant improvement R0 resection (Radiation~     oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and~     enhance disease free and overall survival in this patient population.~   "
145775|NCT01659047|"~     The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and~     duration of tumor control~   "
145622|NCT01661075|"~     The purpose of this pilot project is to determine whether using inertial sensors placed on~     the waist during routine clinical balance testing (i.e. Balance Error Scoring System) (BESS),~     will be a more immediate, objective, reliable and sensitive way to measure and quantify~     balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators~     are also trying to observe if the sensors can be used to detect balance recovery after a~     mTBI.~      The investigators hypothesis is that collegiate atheltes with mTBI injury will have different~     recovery periods between their cognitive testing(IMPACT) and their balance measures.~   "
145623|NCT01661062|"~     Cone beam CT (computed tomography) is a developing technology which allows CT images to be~     obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to~     produce detailed pictures of structures in the body.) In this study, cone beam CT scans will~     be obtained before individual radiation treatment sessions for head and neck cancer. The~     information gathered from these scans will be used by the researchers to look at patient~     movement as well as changes in the amount of normal and tumor tissue throughout the course of~     radiation therapy. The researchers will use this information to create hypothetical radiation~     treatment plans, which will be used as the basis for future research. The cone beam CT scan~     data will not be used to alter the actual radiation treatment of any of the patients enrolled~     on the study. In addition, tests of salivary output and swallowing and questionnaires about~     quality of life will be made to assess how the doses of radiation affect them.~   "
145624|NCT01661049|"~     To see how a cohorte of 55 patients over periode 1997-2011 were mannaged, treated and~     survived duodenal cancer. Also to see how advanced the tumors were at time of diagnose and at~     time of operation.~   "
145625|NCT01661036|"~     Background:~      - The Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey is designed to look at~     health-related topics. It is being developed for the Department of Health and Human Services.~     Researchers want to see how easy or difficult the FLASHE survey questions are to understand~     and answer. They will interview parents and teenagers to test the survey questions.~      Objectives:~      - To test the FLASHE survey questions on teenagers and their parents.~      Eligibility:~        -  Adolescents between 11 and 18 years of age.~        -  Parents of the participating adolescents.~      Design:~        -  Participants will have a one-on-one interview to test the survey questions. The~          interview will last up to an hour and a half. Participants will be allowed to skip any~          questions that they do not wish to answer.~        -  Participants will receive financial compensation for their time.~   "
145626|NCT01661023|"~     Background:~      - Breast cancer is becoming more common in Africa. A higher number of cases appear in women~     under age 35 than in the developed world. However, little is known about the factors that may~     contribute to breast cancer in Africa. Researchers want to collect information from female~     patients in teaching hospitals in Accra and Kumasi, Ghana and to compare this information~     with that obtained from healthy women in the general population. These two hospitals treat~     most breast cancers in Ghana. The data will provide information regarding factors that~     predispose to the development of breast cancer among women in Ghana.~      Objectives:~      - To identify and study breast cancer risk factors in women in Ghana.~      Eligibility:~        -  Women between 18 and 74 years of age who are diagnosed with breast cancer.~        -  Participants will come from teaching hospitals in Accra and Kumasi, Ghana. Women without~          breast cancer will be identified from the 2010 Ghanaian Census for comparison purposes~      Design:~        -  Participants will answer questions about their health and lifestyle.~        -  Height, weight, and waist/hip measurements will be collected.~        -  Blood and saliva samples will be collected.~        -  Participants will be given a collection kit to collect a stool sample.~        -  Treatment will not be provided as part of this study.~   "
145627|NCT01661010|"~     Purpose/Lay Summary: Background:~      - Chromosomes are the structures inside of each cell that carry our genetic material (genes).~     Certain differences in the sex chromosomes are known to cause various diseases, such as~     infertility, Turner syndrome, or Klinefelter syndrome. However, it is not fully understood~     why these differences are seen and what clinical findings may be caused with different sex~     chromosome variants. This study is seeking to learn more about the genetic and clinical~     characteristics of disorders related to the X and Y chromosomes.~      Objectives:~      - To study related medical conditions in people with sex chromosome variants.~      Eligibility:~        -  Patients with known sex chromosome differences may be eligible to participate.~        -  Healthy volunteers age 18 - 55~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  This study will last about 5 days. Participants will have a variety of endocrine and~          other tests. They will provide blood, urine, and semen samples for these tests.~        -  Imaging studies of the heart and abdomen will be performed. These tests may include~          ultrasounds and magnetic resonance imaging.~        -  Participants will also have their vision and hearing checked.~        -  Healthy volunteers with have a single day visit for a medical history, physical exam,~          and blood and skin samples.~        -  Treatment will not be provided as part of this study.~        -  Compensation is offered.~   "
145639|NCT01660854|"~     In a previous study (NL33904.091.10) the investigators challenged 24 volunteers after~     Chloroquine Prophylaxis Sporozoites (CPS) immunization with 45, 30 or 15 infected~     mosquito-bites respectively. The availability of this immunized cohort opens the unique~     opportunity to determine protection to a heterologous challenge for both of the protected and~     unprotected volunteers as the previous challenge infection might have served as immunological~     boost to the unprotected volunteers.~      In the current observational, proof of principle study, the investigators aim to investigate~     the protection on an individual basis of these previously immunized and challenged volunteers~     against a heterologous P. falciparum challenge.~   "
145640|NCT01660841|"~     Purpose of the study is to look at the safety (what are the side effects) and efficacy (how~     well does it work) of gadobutrol when used for taking images of the brain and spine. The~     results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images~     taken without contrast (gadobutrol).~   "
145665|NCT01660516|"~     Tea consumption may impact upon the decrease in endothelial function after IR-injury.~     However, no previous study directly examined the potential of tea to impact upon the change~     in endothelial function after IR-injury.~      The investigators hypothesize that tea consumption counteracts endothelial damage in response~     to ischaemia reperfusion injury in healthy humans.~   "
145628|NCT01660997|"~     Background:~      - Smoldering multiple myeloma (SMM) is a condition that can lead to multiple myeloma, a type~     of blood cancer. In many high-risk cases, SMM can develop into multiple myeloma in less than~     2 years. The current standard of care for SMM is follow-up without treatment until multiple~     myeloma develops. However, some drugs are being studied to see if they can slow down or~     prevent the disease from progressing. One such drug is MLN9708. It has shown some results~     against multiple myeloma. Researchers want to combine MLN9708 with dexamethasone to see how~     it works against high-risk SMM.~      Objectives:~      - To see if MLN9708 with dexamethasone is a safe and effective treatment for high-risk~     smoldering multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age who have high-risk smoldering multiple myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and a bone marrow biopsy may also be~          performed.~        -  Participants will take MLN9708 and dexamethasone on a regular schedule for 28 days. They~          will take each drug four times at regular intervals during each cycle of treatment.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will have 12 cycles of treatment. After four cycles, patients will be~          recommended to have their own stem cells collected and stored. This will allow the~          potential application of a highdose melpahalan/autologous stem cell transplant in the~          event there is a need in the future (not part of this study).~        -  After 12 cycles, participants will keep taking MLN9708 as long as the disease does not~          progress and the side effects are not too severe.~   "
145629|NCT01660984|"~     Background:~      - Medullary thyroid cancer (MTC) is a rare cancer of the thyroid gland. In children and~     adults, it is often part of a condition called Multiple Endocrine Neoplasia 2 (MEN2). MEN2 is~     usually caused by a genetic mutation, and it can cause a number of problems in addition to~     MTC. These problems include adrenal gland tumors, hormone changes, and problems with the~     bones and other organs. Not much is known about how MTC develops over time, especially in~     people with MEN2. Researchers want to study MTC in children and adults and see how it affects~     their growth and development.~      Objectives:~      - To study how medullary thyroid cancer affects children and adults over time.~      Eligibility:~      - Children and adults who have medullary thyroid cancer.~      Design:~        -  Participants will be screened with a brief physical exam and medical history. Blood and~          tissue samples will be collected to see whether participants have the MEN2 genetic~          mutation.~        -  Treatment will not be provided as part of this study. However, participants will be~          receiving standard care for MTC. They may be eligible for other clinical trials at the~          National Institutes of Health.~        -  Participants will have regular study visits every 6 to 12 months to evaluate their MTC~          and any treatment. Blood tests, imaging studies, and other tests may be performed as~          needed to monitor the disease.~        -  Participants and their parents/guardians will also complete questionnaires about their~          health and emotions during the study.~   "
145630|NCT01660971|"~     This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and~     dasatinib when given together with erlotinib hydrochloride in treating patients with~     pancreatic cancer that has spread to other places in the body or cannot be removed by~     surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Dasatinib and erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and~     dasatinib together with erlotinib hydrochloride may kill more tumor cells.~   "
145631|NCT01660958|"~     Project Grow Smart evaluates the impact fortification with multiple micronutrient powders~     (MNP) vs. placebo (one vitamin) on child development (primary outcome) and on micronutrient~     status, growth, and morbidity (secondary outcomes) among young children in rural India~     (Nalgonda district of Telegana). There is an infant phase and a preschool phase;~     investigators, study team members, and participants are unaware of whether the fortification~     is MNP vs. placebo.~      The infant phase (enrollment age: 6-14 months) is a 4-cell factorial randomized trial (MNP~     vs. placebo and early learning vs. routine care), conducted through home visits. Sachets~     (MNP/placebo) are distributed to be mixed with food. The hypotheses in the infant phase are:~     1) MNP leads to better development, growth, and micronutrient status; 2) Early learning leads~     to better development; 3) Integrated MNP plus early learning leads to better development~     through both additive and synergistic processes. Developmental evaluations and anthropometric~     measurements are conducted at baseline, mid-line (6 months), and end-line (12 months). Blood~     draws for micronutrient status are performed at baseline and endline. Morbidity measures are~     collected monthly using a morbidity form, modeled after the Demographic and Health Survey.~      The preschool phase (enrollment age: 30-48 months) is conducted in Anganwadi Centers (AWC)~     (preschools). AWC are classified as high or low stimulation, based on an objective~     observational rating system of the physical environment of the preschools and teacher-child~     interactions. Preschools are categorized into high/low-quality based on median split,~     followed by random assignment of MNP/placebo nested within high/low-quality preschools. The~     hypotheses in the preschool phase are: 1)MNP leads to better development, growth, and~     micronutrient status; 2) the effect of the MNP on preschoolers' development varies by the~     quality of the AWC, with stronger effects among preschoolers in high-quality AWCs. The~     intervention has been modified to coincide with the academic term (September-May).~     Evaluations are conducted at baseline (September) and end-line (prior to May), with an~     8-month intervention period.~   "
145632|NCT01660945|"~     The investigator hypothesize that vytorin may improve vascular and insulin resistance in~     hypercholesterolemic patients~   "
145633|NCT01660932|"~     The investigators hypothesize that omega does-dependently improves vascular and insulin~     resistance.~   "
145634|NCT01660919|"~     The investigators hypothesize that rosuvastatin does-dependently worsens insulin sensitivity.~   "
145635|NCT01660906|"~     This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse~     Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from~     imatinib to dasatinib.~   "
145636|NCT01660893|"~     The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and~     Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.~   "
145637|NCT01660880|"~     -  To estimate dopamine receptor occupancy by aripiprazole using computer simulation~        -  To measure dopamine receptor occupancy by aripiprazole in patients treated with the~          antipsychotics~        -  To validate the simulation result by comparing the receptor occupancy from the~          simulation with that from the patients~   "
145638|NCT01660867|"~     This is a prospective, randomized, controlled, double-blinded, clinical trial~      Subject : 3mo ~ 24mo. aged infants with bronchiolitis~      The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.~   "
145666|NCT01660503|"~     Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in~     rats and in adolescent boys and girls.~   "
145641|NCT01660828|"~     Strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin~     levels. The underlying mechanism is not yet elucidated, but could be explained by changes due~     to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion~     injury. If the mechanism underlying the troponin release during exercise is similar to that~     of ischemia reperfusion injury (IRI), than it should be susceptible to remote ischemic~     preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI. To test this~     hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding~     RIPC.~   "
145642|NCT01660815|"~     This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed~     throughout the body of Japanese subjects.~   "
145643|NCT01660802|"~     This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug~     Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month~     double-blind period versus sham followed by a 2 month open label period.~   "
145644|NCT01660789|"~     This study aims to evaluate the effect of a 40- week multifactorial intervention against~     overweight, obesity and physical inactivity in Danish children.~      The investigators wish to examine 40 children before and after the Fit for Kids~     intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip~     ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat~     mass.~      Furthermore the investigators wish to examine the more specific inflammatory, metabolic and~     hormonal effect of the intervention with a more extensive examination programme.~      The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring, pedometer~     monitoring, cognitive testing, Continuous Glucose Monitoring System, different metabolic and~     inflammatory markers and an oral glucose tolerance test. The study will take place at Centre~     of Inflammation and Metabolism, Rigshospitalet, Copenhagen.~      The study is a randomised controlled trial with a gradual rollout. The 40 children will be~     randomised. Twenty children will start the intervention at baseline and 20 children will~     start after the first 20 weeks of intervention, thus providing a control group.~      The investigators expect to find a significant reduction in BMI, total body fat mass and~     systolic blood pressure after the intervention. As for the more extensive tests, the data~     approach is explorative, as the investigators look at more statistical dependent variables.~     The contribution of this project is a further description on the effect of intervention~     against overweight and physical inactivity on the metabolic and inflammatory response.~   "
145645|NCT01660776|"~     Diffuse large B-cell lymphomas (DLBCLs) represent 25 to 30% of adult non-Hodgkin lymphomas in~     western countries. DLBCLs are aggressive cancer but potentially curable with multi-agent~     chemotherapy. Whereas R-CHOP regimen has led to a marked improvement in survival, this~     disease remains a biologically heterogeneous entity. New therapeutic strategies are required~     including identification of patients' subgroups with different prognostic.~      This project is based on BMS_LyTrans and Goelams 075 clinical trial. A study of whole blood~     transcriptome in 75 DLBCL patients and in 87 controls showed that PD-L1 (CD274) gene was~     overexpressed in DLBCL patients. Preliminary results demonstrated that PD-L1 is detected in~     plasma of DLBCL patients with a significantly higher concentration than in controls. This~     protein was selected as a potential biomarker because of its established role in anti-tumoral~     immunity. Interaction between PD-L1 and its receptor PD-1 is known to inhibit activation of~     immune responses by inducing T-lymphocytes anergy and/or apoptosis. Moreover, a direct~     involvement of PD-L1 in the protection of cancer cells from lysis by activated T lymphocytes~     has been demonstrated. PD-L1 expression has been described in several solid tumours,~     including ovary cancer, breast cancer, colon cancer, renal cell carcinoma, non-small cell~     lung carcinoma and in hematological malignancies such as T-NHL, MM and Hodgkin's lymphoma.~     Furthermore the expression of PD-L1 by tumour cells is associated with poor prognosis. The~     blockade of PD-L1/PD-1 axis may represent a novel therapeutic approach in aggressive cancers.~     These first results incite to identify the cells releasing soluble PD-L1 and to investigate~     its role in the anti-tumoral immunity in DLBCL patients.~      The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at~     diagnosis in comparison to others tumours known to express PD-L1 (metastatic breast cancer,~     Hodgkin's lymphoma, non-small cell lung cancer).~   "
145646|NCT01660763|"~     The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA~     System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute~     moderate to severe post-operative pain after total unilateral knee or total unilateral hip~     replacement surgery.~   "
145647|NCT01660750|"~     This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated~     dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex)~     prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant~     eligible multiple myeloma.~   "
145648|NCT01660737|"~     The aim of this observational study is to document the therapeutic use of PASCALLERG ® for~     hay fever. Based on the survey is a decrease in disease-specific symptoms when taking~     PASCALLERG ® over a period of 4 weeks will be documented. In addition to the compatibility~     can be assessed.~   "
145649|NCT01660724|"~     The main purpose of the study is to evaluate whether the routine use of ultrasound guided~     arterial puncture can increase the proportion of patients who only needs one puncture attempt~     in order to successfully extract enough blood to make an arterial blood gas analysis, when~     ultrasound guided arterial puncture is compared to conventional arterial puncture technique.~   "
145650|NCT01660711|"~     The purpose of the study is to demonstrate that it is possible to administer chemotherapy~     prior to and following surgery for pancreatic cancer which is considered operable. The~     chemotherapy chosen is that which has been shown to be the most effective in treating~     metastatic disease, and the goal is both to investigate whether this is tolerable and also to~     investigate the efficacy of this approach in terms of disease response and survival.~   "
145651|NCT01660698|"~     The purpose of the current study is to evaluate the effect of administering a probiotic~     strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in~     seasonal allergic rhinitis subjects.~   "
145652|NCT01660685|"~     This is a randomized controlled trial with enhanced usual care treatment control. The aim is~     to determine the effects of journaling and use of resource website on weight loss. There will~     be two groups of 55 participants each. The intervention condition will be asked to record~     daily weight, physical activity steps taken and pre-portioned food items and to complete two~     daily journaling activities. Participants will also receive weekly tracing data, a weekly~     blog from the principal investigator and have access to a weight control website. The control~     group will not have access to the tracking, journaling or website for three months.~     Investigators hypothesize that a website paired with tracking and journaling will be more~     effective in helping participants lose weight.~   "
145776|NCT01659034|"~     The purpose of this study is to evaluate safety of reduction of thienopyridine treatment~     period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.~   "
145654|NCT01660659|"~     Personal exposure to Indoor Air Pollution (IAP) is a known risk factor of severe pneumonia,~     which is the number one killer of children under five in developing countries. The main~     source of IAP in developing countries is cooking fires, with an estimated 3 billion people~     still reliant on biomass stoves for their daily cooking. This study will test the~     effectiveness of an intervention aimed to reduce IAP, as well as help to quantify the~     relationship between exposure (IAP) and infection (pneumococcal carriage).~      In Phase I (adjunct pilot study L2010.99), 3 fuels and 5 stoves were tested to measure~     harmful pollutant emissions. The preliminary results showed that the largest difference was~     found in the fuels (briquettes cleaner than wood), with a smaller difference found between a~     couple of the improved stoves and the traditional 3-stone. Re-testing of selected stove/fuel~     combinations to confirm findings has just been completed. Phase II (this proposal) will test~     the biomass briquettes in a randomized clinical trial to measure actual IAP reductions in~     households. A proof of concept pneumococcal survey will also be conducted as a secondary~     study to see whether reduced exposure to IAP affects pneumococcal carriage in babies and~     mothers~   "
145655|NCT01660646|"~     This is a cluster Tuberculosis (TB) randomized trial in which enhanced case finding (ECF)~     strategy will be compared to passive TB case reporting in The Gambia. And that the impact of~     ECF on community and household transmission of TB will also be assessed.~      The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will~     increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost~     effective manner. The impact of ECF on community and household transmission of TB will also~     be assessed. The investigators hope this trial will contribute to this evidence base. The~     timing alongside a nationwide TB prevalence survey is particularly of benefit as that would~     provide a baseline for disease burden against which the investigators may be able to compare~     case notification or case detection in selected clusters~   "
145656|NCT01660633|"~     The purpose of this trial is to confirm the safety and efficacy of high-dose Melphalan HCL~     for Injection (Propylene Glycol-Free) as a myeloablative conditioning regimen in multiple~     myeloma patients (MM) undergoing autologous transplantation.~   "
145657|NCT01660620|"~     We hypothesize that topical betaxolol will reduce the development of severe retinopathy of~     prematurity.~   "
145658|NCT01660607|"~     For patients with hematologic malignancies undergoing allogeneic myeloablative (MA) HCT with~     a T cell depleted graft, the infusion of naturally occurring regulatory T cells with~     conventional T cells (T cell addback) in pre-defined doses and ratios will reduce the~     incidence of acute graft vs host disease while augmenting the graft vs leukemia effect and~     improving immune reconstitution.~   "
145659|NCT01660594|"~     Patients with stable chest pain presenting to general practitioners in UK are routinely~     referred to the chest pain clinics in the hospitals. They are assessed by clinical history~     including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT~     calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying~     calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical~     Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain who~     have low likelihood of coronary artery disease (CAD). They recommend that patients with low~     likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have~     non-cardiac chest pain. However, there is controversy regarding relationship of absent~     calcification with significant CAD and its prognostic value.~      At our institution, we have been performing CTCS in this patient cohort since 2003. We plan~     to retrospectively review the usefulness in CTCS in patients with different likelihood for~     significant CAD, particularly in patients with absent calcium and compare with the~     traditional assessment. We also plan to follow-up these patients for any myocardial~     infarction and death from any cause.~   "
145660|NCT01660581|"~     The purpose of the study is to evaluate the efficacy of therapy with autological CD133+ cells~     in patients with angina resistant to pharmacological treatment and without the possibility of~     effective revascularization. Cells will be isolated from patients bone marrow and~     administered directly into the muscle of left ventricle. The main objective is to assess the~     treatments' influence on improvement of myocardial perfusion and function, and on decrease of~     occurrence of symptomatic angina.~   "
145661|NCT01660568|"~     We retrospectively review patients with refractory or relapsed ENKL who received a~     gemcitabine-containing regimen~   "
145662|NCT01660555|"~     The human microbiota forms a highly complex ecosystem with its host, consisting of hundreds~     of different species of microorganisms, the majority of which have not yet been cultured.~     With the recent advent of small subunit rRNA (SSU rRNA) gene sequencing technology, it is~     estimated that the number of specific gastrointestinal tract phylotypes is more than 1800.~     Sampling techniques might constitute a major confounder in the read-out of highly sensitive~     techniques such as SSU-DNA analysis.~      It is not properly established whether there is a difference in distribution of luminal~     bacteria or mucosa adherent bacteria proximal or distal in the colon. In addition, 'bowel~     lavage' before endoscopy might result in a disturbance of the microbiota in the bowel. For~     this proof of concept study a novel device capable of taking 'protected' biopsies has been~     designed.~      We hypothesize that the distribution of mucosal and luminal microbiota changes from proximal~     to distal in the colon, and by taking 'protected biopsies' there will be the opportunity to~     show the real distribution of microbiota according to the localisation in the colon.~      Furthermore, we hypothesize that microbial diversity will differ after bowel lavage.~   "
145663|NCT01660542|"~     This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of~     sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by~     4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or~     cytologically confirmed axillary lymph nodes metastasis.~   "
145664|NCT01660529|"~     Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV~     multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive basiliximab~     20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be administered at the~     time of Vaccines 1,3, and 5. Patients who remain clinically stable after the fourth vaccine,~     may continue to receive vaccinations every 4 weeks for up to 2 years.~   "
145777|NCT01659021|"~     This study will evaluate the effect of the addition of idelalisib (GS-1101) to ofatumumab on~     progression-free survival (PFS) in participants with previously treated chronic lymphocytic~     leukemia (CLL).~   "
145667|NCT01660490|"~     An expert panel of surgeons agreed that there is not any established, standardized approach~     to the teaching of intraoperative imaging and that there may be practice gaps in decision~     making and the use of imaging among trauma surgeons.~      The panel is set to initiate a consensus-based evaluation process to develop a list of~     criteria for assessing images and would like to validate these criteria for differentiating~     good quality versus poor quality images in term of reliability and accuracy.~   "
145668|NCT01660477|"~     The purpose of this two part study is to assess the effect of multiple doses of isavuconazole~     on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the effect of multiple~     doses of lopinavir/ritonavir on the pharmacokinetics of isavuconazole.~      Part 1 of the study includes 12 subjects randomized to receive either isavuconazole alone or~     isavuconazole in combination with lopinavir/ritonavir. The purpose of Part 1 is to evaluate~     safety and tolerability and to establish the effect of multiple doses of lopinavir/ritonavir~     on isavuconazole.~      Part 2, if initiated, includes 54 subjects randomized to receive isavuconazole alone,~     lopinavir/ritonavir alone, or isavuconazole in combination with lopinavir/ritonavir.~   "
145669|NCT01660464|"~     Cognitive-behavioral based guided self-help for parents of adolescents with~     Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and~     effectiveness study. The treatment is offered under routine-care conditions of the~     health-care system in Germany. Practicability, treatment participation and effectiveness is~     documented and tested in a one-group pre-test/post-test design.~   "
145670|NCT01660451|"~     The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in~     patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after~     standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group.~     The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of~     BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be~     enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics~     and biomarkers. Quality of life will be a further objective of part B of the study.~      In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed~     to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.~      After an up to 28-day screening period, eligible patients will start treatment with~     BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).~      Treatment will be continued until disease has progressed or until another criterion is met~     for withdrawal from study. An end-of-treatment visit will be performed within 7 days after~     discontinuation of study treatment. Thirty to 35 days after last study drug administration, a~     safety followup visit will be performed for the collection of adverse events (AEs) and~     concomitant medication data. Patients will be contacted quarterly to determine overall~     survival status up to 3 years after last patient first treatment. In Part B, patients will~     enter the Active Assessment Followup Period. The end of study notification to Health~     Authorities will be based on the completion of the collection of survival data.~      The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at~     Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months~     during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor~     tissue and blood samples will be collected for biomarker analysis (mandatory) and for central~     pathology review (part B), fresh biopsy tissue will also be collected if available.~   "
145671|NCT01660438|"~     This is a prospective, non-randomized, observational, multicenter study in which urethral~     length is measured in women with surgically-correctable stress urinary incontinence who~     undergo a suburethral sling operative procedure.~   "
145672|NCT01660425|"~     The main purpose of this study is to evaluate the effectiveness of a parenting enhancement~     training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity~     Disorder (ADHD) who are already medicated with methylphenidate.~   "
145673|NCT01660412|"~     Pain during nuclear medicine breast lymphnode detection procedures has been reported as high~     as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain~     can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures.~      In sites other then the breast, using Bicarbonate to make the injection's pH closer to~     natural, attempts to lower the pain levels will be performed.~      Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be~     reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH~     7.40.~   "
145674|NCT01660399|"~     This predictive, randomized, double-blind, multi-center trial is going to evaluate the~     efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a~     second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous~     cell lung cancer patients.~   "
145675|NCT01660386|"~     The objective of this study is to demonstrate the different effects of two DPP-4~     inhibitors(Sitagliptin, Saxagliptin)and the insulin secretagogue: glimepiride on first and~     second phase insulin secretion by using a Biphase-Hyperglycemic Clamp and to explore the~     different effects of the study drugs on the GLP-1 response, and the glucagon concentration~     which indicates alpha cell function in healthy subjects.~   "
145676|NCT01660373|"~     This is a single-center, open-label prospective randomized pharmacodynamic investigation of~     two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment~     elevation acute coronary syndrome(NSTE-ACS) for 24 hours~        1. Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid)~        2. Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min~             -  both agents will be given on top of aspirin~   "
145677|NCT01660360|"~     The primary objective of this study is to assess the safety, tolerability, and maximum~     tolerated dose (MTD) of Tanibirumab in patients with advanced or metastatic cancer who are~     refractory or for whom there are no standard therapeutic option.~        -  To evaluate the pharmacokinetics of Tanibirumab in such patients~        -  To determine a recommended phase II dose (RP2D) of Tanibirumab based on above~          assessments~   "
145678|NCT01660347|"~     This clinical trial studies how well donor stem cell boost works in treating patients with~     low blood cells after donor stem cell transplant. Donor stem cell boost may increase low~     blood cell counts caused by hematologic cancer or its treatment.~   "
145679|NCT01660334|"~     To collect the efficacy and safety information of voriconazole related to their appropriate~     use in daily practice.~   "
145680|NCT01660321|"~     A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in~     pediatric subjects 6 months to 4 years of age with an active head lice infestation.~   "
145703|NCT01659983|"~     Research hypothesis:~      Does delayed primary wound closure after appendectomy in adults with complicated appendicitis~     reduce postoperative superficial surgical site infection compare to primary wound closure.~      Study design:~      This study is a multicenter randomized controlled trial of delay versus primary wound closure~     in complicated appendicitis.~      Setting:~      Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira~     Hospital, and Pathumthani Hospital~      Participants:~      Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as~     gangrenous or ruptured appendicitis.~      Outcome:~      Superficial surgical site infection~      Period of study:~      August 2012 - August 2014~   "
145681|NCT01660308|"~     Fibroblast froth factors (FGFs) are humoral factors identified by their ability to stimulate~     cell proliferation1. They play different roles in the regulation of cell proliferation,~     differentiation and function. Most FGF family members act as paracrine factors. But~     FGF19(FGF19) subfamily members, including FGF19, 21, and 23, work as endocrine factors to~     regulate bile acid, carbohydrate and phosphate metabolism2. Of these, FGF23 plays an~     important role in phosphate and bone metabolism3. FGF23 gene encodes 251 amino acids,~     including a 24-amino acid signal peptide4. The secreted FGF23 is a protein consisted of 227~     amino acids. It works by binding to a Klotho-FGF receptor 1c (FGF1c) complex5. FGF suppresses~     the expression of type 2a and 2c sodium-phosphate cotransporters, which mediate phosphate~     reabsorption in proximal tubules.6 FGF23 decreases 25-hydroxyvitamin D-1α-hydroxylase~     expression and enhances 25-hydroxyvitamin D-24-hydroxylase expression6. Therefore, FGF23~     reduces serum 1,25-dihydroxyvitamin D〔1,25(OH)2D〕, which stimulates intestinal calcium and~     phosphate absorption. FGF23 decreases serum phosphate through the above mechanisms FGF23~     over-expression might result in hypophosphatemic rickets and osteomalacia.~      Tumor induced osteomalacia (TIO) is a paraneoplastic syndrome usually caused by benign~     phosphaturic mesenchymal tumors. Symptoms are nonspecific, such as general weakness, fatigue,~     and bone pain. Sometimes fracture may occurs. The responsible tumors are sometimes small and~     difficult to detect. Tumors secrete FGF23. FGF23 reduced phosphate reabsorption in the~     proximal tubules and decrease 1,25(OH)2D levels, which result in hypophosphatemia and then~     osteomalacia.~      The investigators would like to observe the changes of FGF23 in patients who receive~     operation or medical treatment and hope this will benefit future treatment.~   "
145682|NCT01660295|"~     This study will assess the pharmacokinetics in subjects with severe renal insufficiency and~     healthy subjects.~   "
145683|NCT01660256|"~     The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective~     compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a~     reference drug.~   "
145684|NCT01660243|"~     This study is being conducted to investigate the efficacy of MT-9938 compared with placebo~     after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the~     effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains,~     especially those which recent research suggests have a positive correlation with overall~     survival for this patient group. The study will consist of the following phases: Screening (1~     to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating~     in a Follow-up Visit (1 week after the last dose).~   "
145685|NCT01660230|"~     The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and~     multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.~   "
145686|NCT01660217|"~     This is a randomized controlled study. The control group will consist of adult subjects and~     the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis (AD),~     who are visiting a dermatologist for a standard AD office visit. In the control group, only~     verbal instruction (VI), the standard of care, will be provided. The intervention group will~     receive a similar VI with an additional component: an eczema education handout, as well as an~     individualized written Eczema Action Plan (EAP) that will illustrate how to recognize disease~     flare-ups and subsequent remissions. In addition, the EAP will provide detailed step-wise~     instructions regarding treatment modifications for the above-mentioned variations in~     treatment severity. To ensure that all patients ultimately receive the same level of care,~     the control group will also receive an EAP at the end of their consultation.~      The goal of this study is to assess subjects' perception in the provider's use of an EAP and~     its effectiveness in helping patients understand their disease and management plan. In order~     to evaluate the primary end-points, subjects in both the control and treatment groups will be~     asked to complete post-consultation surveys. Four post-consultation outcomes will be~     measured: (1) caregivers' understanding of the disease and treatment, (2) caregivers' comfort~     level in following the EAP at home, (3) caregivers' anxiety level in managing the AD at home,~     and (4) caregivers' preference for VI + EAP as compared to VI alone, EAP alone, or neither~     the EAP nor the VI.~   "
145687|NCT01660204|"~     The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic~     strategies for patients with community-acquired pneumonia admitted to the hospital, but not~     the ICU.~   "
145688|NCT01660191|"~     The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin~     or Rosuvastatin.~   "
145689|NCT01660178|"~     To describe the profile of newborns undergoing early stimulation in a neonatal intensive care~     unit, characterizing the study population, according to its variables and neonatal risk~     factors, indications for treatment of early stimulation.~   "
145690|NCT01660165|"~     There is increasing evidence that psychosocial factors may affect health by means of~     biological effects and changes in behavioral health. Observational studies suggest an~     association between low levels of one long chain n-3 fatty acids, DHA (docosahexaenoic acid),~     after pregnancy and the occurrence of postpartum depression (PPD). This is an observational~     cohort with 4 waves of follow-up and a nested clinical trial with pregnant women residing in~     the city of Rio de Janeiro. The general objective is to describe the magnitude and identify~     factors associated to common mental disorders (CMD) during pregnancy and postpartum giving~     emphasis to maternal nutritional status.~      Main specific objectives:~        1. To evaluate the effect of CMD in the pattern of occurrence of selected maternal and~          child outcomes (inadequacy of gestational weight gain, postpartum weight retention, low~          birthweight, small for gestational weight and prematurity), considering the effect of~          other determinant factors, and~        2. To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.~   "
145691|NCT01660152|"~     The purpose of this study is to determine which technique in using a vacuum erection device~     (VED) is best. Erectile dysfunction (ED) after robotic prostate cancer surgery is a concern~     for both the surgeon and the patient. Recent studies have shown that beginning to use the~     vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile~     shrinkage. This is a potential issue that can occur because of decreased blood flow after~     prostate cancer surgery. This study will allow researchers to determine and compare vacuum~     therapy techniques and erectile function outcomes of patients who have prostate cancer~     surgery~   "
145692|NCT01660139|"~     This study is to assess the practice of complementary and alternative medicine (CAM) for skin~     related conditions among patients in the Primary Care and Dermatology clinics.~   "
145704|NCT01659970|"~     This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in~     second line in patients with locally advanced or metastatic squamous non-small cell lung~     cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients~     will be followed for 12 months.~   "
145778|NCT01659008|"~     Treatment with Estradiol is non-inferior to treatment with Tranexamic acid in reducing the~     amount and duration of menstrual blood loss in women with cyclic heavy menstrual bleeding~   "
145693|NCT01660126|"~     Subclinical hypothyroidism (SCH) is a common condition among older men and women. Although by~     definition SCH comprises biochemically mild thyroid hormone deficiency without overt~     symptoms, it is a possible contributor to multiple problems in older age. Thyroid hormone has~     effects on numerous physiological systems, including the vascular tree, heart, skeletal~     muscle and brain. Therefore, thyroxine substitution to overcome thyroid hormone deficiency~     has the potential to give multisystem benefits to older people with SCH.~      Small studies have reported reduced atherosclerosis and improved heart function with~     thyroxine replacement, but no large clinical trials have been performed. Therefore the~     available evidence is limited, leading to major variations in guidelines and clinical~     practice, with uncertainty regarding the indications for screening and treatment. The~     investigators propose a multicentre randomised placebo controlled trial to assess the impact~     of thyroxine replacement in a minimum of 540 older adults (maximum 750) with persisting SCH~     (excluding those in whom it is a temporary phenomenon who are unlikely to benefit). The~     investigators will include older men and women with a wide age range and of varying health~     status. Outcomes include health related quality of life, muscle strength, executive cognitive~     function and cardiovascular events, with a minimum of 1 year of follow up. Blood and urine~     samples will be stored in a biobank, to allow future research on causes of ill health in~     older people with SCH.~      The investigators have the support of patient advocacy groups and a consortium with the wide~     range of expertise and experience required to conduct large scale multicentre clinical~     trials. The proposal explores the multisystem and quality of life benefits to older people of~     a tailored approach to management of SCH.~      This clinical trial should definitively clarify whether thyroxine treatment for SCH provides~     benefits that are relevant for patients. This trial will provide strong evidence with the~     potential to improve clinical practice, reduce health care costs and promote healthy ageing~     of older adults.~   "
145694|NCT01660100|"~     Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF)~     ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation~     plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be~     conducted in patients with different types of AF: paroxysmal AF (PAF) and non-PAF (Persistent~     AF and Long Standing Persistent AF).~      Hypothesis: In addition to permanent pulmonary vein antrum isolation, proven isolation of~     left atrial posterior wall is associated with more freedom from atrial arrhythmia at~     long-term follow-up after atrial fibrillation ablation, especially in non-PAF patients.~   "
145695|NCT01660087|"~     The overall objective of this proposal is to develop a non-invasive, inexpensive and accurate~     device that detects VOCs in exhaled breath for lung cancer screening. Toward this goal, the~     team will design and fabricate a biophotonic platform consists of arrays of silicon~     micro-ring resonator sensors coated with polymers with different organic functionalities, in~     which each sensor is widely responsive to a variety of VOCs for the detection of lung cancer~     by means of breath testing. The team will identify signature VOCs as lung cancer biomarkers~     by comparison VOC contents between alveolar gas that directly sampled from the nodule or mass~     and exhaled breath using gas chromatography/ mass spectrometry.~      The specific aims of this proposal are as followings:~      Aim 1: To develop a biophotonic platform for the detection of VOCs~      Aim 2: To achieve multiplex detection of VOCs with high sensitivity and specificity using a~     novel biophotonic device.~      Aim 3: To evaluate the device as a lung cancer screening tool by testing both healthy and~     lung cancer breath samples~   "
145696|NCT01660074|"~     The purpose of ths study was to evaluate the glycemic index and glycemic response of food and~     products that produced in Tiwan. The food and product are in includes local produced fruits,~     starchy food and bread made from resistant starch.~   "
145697|NCT01660061|"~     To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with~     the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.~   "
145698|NCT01660048|"~     Since laparoscopic inguinal hernia was introduced in 1990, it has now become the most~     commonly performed hernia repair in NSW. Traditionally this is done with 3 small incisions: a~     2 cm incision under the navel for insertion of the camera and two 1 cm incisions below the~     navel for insertion of trocars into which dissecting instruments are inserted to perform the~     repair. Although this method has been shown to be relatively safe and efficient there are~     reports of bowel and vascular injuries from the insertion of the smaller trocars which are~     usually sharp. These can cause serious injuries.~      Since 2009, a newer method of performing the key hole repair has been developed. This~     involves placing a special single port under the navel via a 2-2.5cm incision and into which~     3 blunt trocars are inserted. This negates the risks of injuries from sharp trocars. In~     addition the fact that only a single incision is used this could potentially result in less~     pain, reduced incidence of wound complications including infection and improved cosmetic~     results.~      However these potential advantages have not been proven in rigorous clinical studies as the~     single port technique is still relatively new. It is hoped that this study will prove that~     the single port technique is at least as effective and efficient as the conventional~     technique in the cure of hernias and may have additional benefits as enumerated above.~      Neither you nor your surgeon will know which procedure (three port or single port hernia~     repair) until you are already asleep in the operating room and a random number selecting~     process will automatically assign you to one procedure or the other. Sometimes it is not~     possible to perform the single port safely in which case your procedure will be converted to~     a three ports procedure.~      All patients having surgical treatment of groin hernia at Holroyd Private Hospital are~     subject to very careful assessment and study. All patients are requested to report~     immediately if there are any problems. Any problems would normally be reported to your~     treating surgeon who has primary responsibility for your care. Problems can be reported~     directly to Holroyd Private Hospital. Any information in your medical records is subject to~     stringent confidentiality requirements. The hospital is bound by the Australian Privacy~     Council Charter as regards confidentiality and privacy.~   "
145699|NCT01660035|"~     The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in~     the REVERSE and RAFT pivotal studies in real-world clinical practice.~   "
145700|NCT01660022|"~     A Phase I Study to investigate the safety, tolerability & pharmacokinetics of co-administered~     single doses of OZ439 and Piperaquine to healthy subjects.~   "
145701|NCT01660009|"~     Prior work suggests exposure to low glucose levels (hypoglycemia) is associated with~     increased cardiovascular risk. However, whether there is a causal relationship between~     cardiovascular events and hypoglycemia remains unclear with conflicting data in the~     literature. In this study, we plan to study whether acute exposure of patients to clinically~     relevant (50-60 milligrams/deciliter) levels of hypoglycemia induces or worsens blood vessel~     endothelial dysfunction- a key 1st step in the development of heart attacks and strokes. This~     will be determined in humans both with and with type 2 diabetes.~   "
145702|NCT01659996|"~     The aim of the study is to further characterize the safety and immunogenicity of Menactra® in~     the population <2 years of age when administered alone and when the second dose is~     administered concomitantly with the 4th dose of Pentacel®, a licensed pediatric vaccine.~      Primary Objectives:~        -  To evaluate and compare the antibody responses to meningococcal serogroups A, C, Y, and~          W-135 induced by 2 injections of Menactra® in subjects aged 9 months at the first~          vaccination visit and 15 to 18 months at the second vaccination visit.~        -  To evaluate and compare the antibody responses to Pertussis (pertussis toxoid [PT],~          filamentous haemagglutinin [FHA] and pertactin [PRN]) antigens induced by a dose of~          Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of~          Pentacel® administered alone.~        -  To evaluate and compare the antibody responses to polyribosylribitol phosphate (PRP),~          tetanus and diphtheria antigens induced by a dose of Pentacel® when administered~          concomitantly with Menactra® to those elicited by a dose of Pentacel® alone.~      Observational Objectives:~        -  To describe the safety profile (immediate unsolicited AEs within 30 minutes of each~          trial vaccination, solicited reactions within 7 days of each vaccination, unsolicited~          AEs within 30 days of each vaccination, and serious adverse events [SAEs] throughout the~          course of the trial from Day 0 up to Day 30 after the last trial vaccination[s]) in all~          trial groups~        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135,~          measured by SBA HC, 30 days after the second Menactra® administration~        -  To describe the antibody responses to Pentacel® (PT, FHA, PRN, FIM, diphtheria, tetanus,~          polio, PRP) measured by enzyme-linked immunosorbent assay (ELISA), radioimmunoassay~          (RIA), or functional assays.~   "
145705|NCT01659957|"~     In treating alcoholism, many studies show Behavioral Couples Therapy (BCT) is more effective~     than typical counseling, but BCT is not widely used because standard BCT delivered one couple~     at a time is costly to deliver and does not fit with the primary group therapy focus of most~     community clinics. The proposed study will test with married or cohabiting alcoholic patients~     whether a group format for BCT will produce similar positive outcomes as standard BCT, and~     deliver these results at a lower cost. If outcomes are favorable, this could prompt clinics~     to start using group BCT and improve outcomes for alcoholic patients and their families.~   "
145706|NCT01659944|"~     The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg~     twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in~     healthy adults.~      The secondary objective is to assess the safety and tolerability of a single oral dose of~     metoprolol 50 mg when administered alone and in combination with repeated oral doses of~     eliglustat 150 mg BID in healthy adults.~   "
145707|NCT01659931|"~     The objective of this study was to prove the bioequivalence of Montelukast Tablet under~     fasted conditions~   "
145708|NCT01659918|"~     The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed~     conditions~   "
145709|NCT01659905|"~     The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet~     under fasted conditions.~   "
145710|NCT01659892|"~     The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet~     under fed conditions~   "
145711|NCT01659879|"~     The aim of this study is to determine whether multimedia based health information presented~     in a pediatric acute ward to parents of children with breathing difficulties due to lower~     respiratory tract infections, is more effective than verbal information to reduce the~     parent's anxiety and to increase satisfaction with nursing care and health information.~   "
145712|NCT01659866|"~     This study is being conducted in men scheduled to undergo transrectal ultrasound-guided~     prostate biopsy (TRUSP). Traditionally prior to prostate biopsy, an antibiotic,~     ciprofloxacin, has been given to men to prevent biopsy-related infections. In recent years as~     ciprofloxacin resistance has increased in the community, more and more men are becoming~     infected with ciprofloxacin-resistant bacteria after prostate biopsy. This study is being~     done to determine if obtaining rectal swab cultures and choosing antibiotics based on these~     culture results will result in fewer infectious complications than giving all men~     ciprofloxacin.~      The investigators will compare 2 groups: men whose rectal swabs do not show~     ciprofloxacin-resistant bacteria will receive ciprofloxacin prior to biopsy, and men whose~     swabs do show ciprofloxacin-resistant bacteria will receive alternative antibiotics based on~     their culture results. Our hypothesis is that these 2 groups will have equal numbers of~     post-biopsy infectious complications and both groups will have fewer infectious complications~     than a historical group who received empiric ciprofloxacin without the benefit of rectal swab~     culture results.~   "
145713|NCT01659853|"~     The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel~     0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily~     in subjects with moderate to severe facial erythema of rosacea.~   "
145714|NCT01659840|"~     The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the~     same efficacy in relieving pain and improving the quality of life of TMD patients~   "
145715|NCT01659827|"~     The purpose of this study is to determine whether the AmnioFix Injectable human amniotic~     membrane is effective in the treatment of recalcitrant plantar fasciitis.~   "
145716|NCT01659814|"~     The overall aim of this study is to utilize an integrative research model in order to~     dynamically assess reward-related dopamine (DA) transmission in major depressive disorder~     (MDD) and test the role of dysfunctional DA release in depression and anhedonia.~      The first arm of this line of research (PET scan) aims to investigate phasic DA release in~     MDD during incentive motivation. The investigators will utilize an established molecular~     imaging technique to measure striatal DA release dynamically during performance of testing~     and control versions of a monetary incentive delay task, which involves anticipation and~     receipt of monetary rewards. In doing so, this experiment will link together independent~     lines of research that have associated depression with decreased hedonic responsiveness,~     impaired reinforcement learning and dysfunctional DA transmission. We hypothesize that,~     relative to matched controls, unmedicated MDD subjects will show reduced reward-related~     ligand (11C-raclopride) displacement. Reduced ligand displacement will be interpreted as~     indicating reduced task-induced release of endogenous striatal DA in response to~     reward-predicting cues and unpredictable reward in MDD subjects.~      In the second arm of this research (EEG recording), the investigators aim to probe the~     spatio-temporal dynamics of brain mechanisms underlying positive and negative reinforcement~     learning in MDD and their relations to phasic DA. Participants will perform the probabilistic~     stimulus selection task (PSST) while event-related potentials (ERPs) are collected. The~     investigators expect that, relative to matched controls, unmedicated MDD subjects will show~     reduced positive reinforcement learning, potentiated negative reinforcement learning, and~     larger (i.e., more negative) feedback-related negativity (FRN) in response to positive~     reinforcement (indicative of reduced DA transmission). Moreover, the investigators~     hypothesize that a more negative FRN in response to positive reinforcement will be associated~     with decreased striatal raclopride displacement (i.e., lower release of endogenous DA) as~     measured by PET in the first part of the study. This experiment will investigate the effects~     of blunted DA transmission on behavioral and ERP markers of both positive and negative~     reinforcement learning.~   "
145717|NCT01659801|"~     With age, a human crystalline lens opacifies (cataract) disabling the eye in generating a~     clear, well contrasted image. The only therapeutic solution to this problem is surgical~     replacement of the crystalline lens with an intraocular lens (cataract surgery).~      In addition to the cataract, the person might suffer from pre-existing cormeal astigmatism.~     In cases of severe corneal astigmatism, the standard IOL might not provide the optimal~     result, and additional surgical procedures as Incisional Keratotomy or Limbal Relaxing~     Incisions might be required.~      BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior~     alternative to surgical treatment of pre-existing corneal astigmatism.~      The BunnyLens TR IOL is designed for micro-incision cataract surgery (MICS), through 1.8mm~     incisions.~      The aims of this study are to:~        -  Demonstrate a reduction in refractive cylinder compared to pre-operative corneal~          astigmatism~        -  Exceed monocular best corrected distance visual acuity results provided in ISO~          guidelines.~   "
145718|NCT01659788|"~     The goal of the investigators research is to explore energy production of the ovarian~     follicle in older reproductive age women at the time of oocyte retrieval.~   "
145770|NCT01659112|"~     The purpose of the study is to determine the effects of the addition of core stabilization~     exercises to a traditional upper extremity rehabilitation program in upper extremity~     injuries.~   "
145792|NCT01658813|"~     The purpose of this study is to determine whether the combination of a 5-Fluorouracil (5-FU)~     and interferon, which is able to stimulate the immune system to kill cancer cells, will help~     to increase tumor shrinkage in previously-treated metastatic gastrointestinal, kidney, or~     lung Cancer.~   "
145719|NCT01659775|"~     This is a multicenter, randomized, open-label, paralleled-group, active-controlled study.~      The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System~     (GTDS) efficacy compared with the ondansetron efficacy with regard to Complete Response (CR)~     of Chemotherapy Induced Nausea and Vomiting (CINV).~      Patients scheduled to receive the one cycle of a HE chemotherapy regimen administered for 1-5~     days will attend a Screening Visit 2 to 14 days before start of HE chemotherapy. Eligible~     patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2~     days prior to HE chemotherapy).~        -  Sancuso patch~        -  Zofran inj. + Zofran tab.~      The patch will be applied 2days (48-24h) prior to first daily dose of the highly emetogenic~     chemotherapy regimen and remain in place for 5 days after start of chemotherapy. The patient~     will be assessed daily until 5days after first chemotherapy administration. Adverse Events~     (AEs) will be collected until 2 days after the final dose of IP. Non-serious AEs will be~     followed-up until 2 days after the final dose of IP. Serious adverse events will be~     followed-up until they are resolved, stable or until the patient is lost to follow-up.~   "
145720|NCT01659762|"~     In this Phase I trial the investigators intend to show safety and tolerability of autologous~     MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media. Fresh,~     non cryopreserved, autologous MSCs will delivered intravenously as a single bolus dose in a~     dose escalation phase I study. The investigators intend to test whether the product is~     clinically safe in adults (18-65 years old) with CD and to determine maximal deliverable~     dose. Secondary endpoint will monitor effectiveness using CDAI as an endpoint.~   "
145721|NCT01659749|"~     The purpose of this project is to study the effectiveness of teaching teens and young women~     with Phenylketonuria (PKU) or Maple Syrup Urine Disease (MSUD) about their disease and~     nutrition related issues in a camp environment. It will also look at pregnancy outcome~     results in women with PKU who attended Metabolic Camp and compare their results to other~     women with PKU who have not attended the Metabolic Camp.~   "
145722|NCT01659736|"~     This study is investigating a new indication of Transcranial Magnetic Stimulation (TMS) by~     conducting a pilot randomized-controlled trial (RCT) comparing structural~     neuronavigation-directed TMS to Sham-TMS Placebo therapy for treatment of Generalized Anxiety~     Disorder (GAD).~   "
145723|NCT01659723|"~     The primary objective of this study is to assess the relief of symptoms after Hyperbaric~     Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate~     cancer Index Composite (EPIC)symptom estimation scale as primary variable.~      Study hypothesis:~        -  HBOT can reduce or reverse the change or otherwise limit the damage of the bladder~          function and/or structure, which arose as a result of radiation therapy of cancer in the~          pelvic region organs.~        -  The effects of HBOT are associated with relief of symptoms that, at least in part, is~          related to the reduction of the extent of the radiation damage.~        -  Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as~          a sign of an improved function of the mucosa.~        -  Treatment results of HBOT remains, in whole or in part, during the follow-up (residual~          effect)~   "
145724|NCT01659710|"~     The purpose of this study is to research a new type of test for cerebral palsy that can be~     performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test~     involves a standardized video recording of a baby's natural movements for about 10 minutes.~     The video recorded movements are evaluated by a special trained observer and also by a~     computer program. There are some small studies from Europe that suggest that this type of~     evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators~     do not know if this type of evaluation is reliable in large groups of infants, including~     infants from Children's Memorial Hospital, who tend to be sicker and have more complicated~     illnesses than many of the European infants. The investigators would therefore like to~     evaluate whether this type of video recording could be used in the future for early diagnosis~     of cerebral palsy.~   "
145725|NCT01659697|"~     This study will evaluate the feasibility and efficacy of two interventions of lifestyle (~     intensive and less intensive) to prevent diabetes in patients from Ethiopian origin, aged 25~     to 55 years old with prediabetes living in Israel and insured by Clalit Health Services in~     the Central district, using resources existing in this Health Care system (HMO).~   "
145726|NCT01659684|"~     Because the potential benefit of standard intravenous immunoglobulins (IVIG) - obtained from~     unselected donor pools including a varying proportion of donors previously exposed to CMV -~     has not yet been explored in pregnant women, the investigators performed a longitudinal~     prospective study on the possible efficacy of IVIG for prevention or therapy of fetal CMV~     infection.~   "
145727|NCT01659671|"~     Hypothesis:Pharyngeal surgery (UPPP) reduces significantly the nightly respiratory breathing~     pauses (apnoeas-hypopnoeas) and improves the daytime symptoms compared to expectancy for 6~     months in patients with OSAS.~      Background: Obstructive sleep apnea syndrome (OSAS) is associated with an increased risk of~     poor sleep quality, excessive daytime sleepiness and prolonged reaction time, which can~     elevate the risk for traffic accidents. Increased morbidity and three to four times increased~     mortality in these patients are well documented, mainly in the cardiovascular field.~     Pharyngeal surgery, i.e. uvulopalatopharyngoplasty (UPPP) opens up the airway and was the~     predominant treatment for OSAS worldwide before continuous positive airway pressure (CPAP)~     devices became widely available in the 1990s. Since then, the main treatment for OSAS has~     been CPAP, but an increasing number of patients are also treated with mandibular retaining~     device (MRD). UPPP as treatment for OSAS has been performed for 30 years. The evidence-grade~     for the efficacy has so far been very low, and the side-effects and complication rate has~     raised the question whether there is a place for surgical treatment of OSAS. However, the~     compliance for CPAP and dental devices are quite low (50-60%), leaving a lot of patients~     untreated if surgery is not offered. RCT UPPP is still missing and called for.~   "
145728|NCT01659658|"~     The purpose of this study is to determine whether dexamethasone plus IXAZOMIB improves~     hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and~     mortality rate versus a physician's choice of a chemotherapy regimen in participants~     diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.~   "
145924|NCT01657071|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by~     Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in~     healthy male volunteers.~   "
145729|NCT01659645|"~     Breast carcinoma is the most frequent cancer in women, affecting an estimated 207,090 in 2010~     leading to 39,840 cancer related deaths.~      Fludeoxyglucose F 18 Injection (FDG) Positron Emission Tomography, (PET) or PET-CT has become~     the a standard method for isolating the tumor. However, FDG is insensitive in small breast~     tumors and certain histologic types such as lobular, certain types of breast carcinoma. In~     addition, FDG uptake can be nonspecific since inflammatory some benign lesions may also~     evidence have accumulation of this radiotracer. Hence there is a need for a tracer/imaging~     tool that increases the ability to characterize detect breast carcinoma and to detect~     locoregional spread, as well as monitor therapeutic treatment response.~      anti-3-[18F]. anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC) is an amino acid~     based PET radiotracer which has shown utility in detecting a variety of tumors. In cell~     culture experiments,FACBC has shown uptake in the breast tumor cell line.~      The primary aim of this study is to determine if FACBC PET-CT demonstrates uptake within~     breast carcinoma (primary site and/or locoregional lymph nodes) and to study uptake kinetics~     via time-activity curves from dynamic imaging characteristics. The investigators will enroll~     12 patients who have a breast mass or masses and/or lymph nodes naïve to therapy about to~     undergo biopsy or post-biopsy pre-therapy. All patients will undergo standard of care imaging~     as appropriate such as mammography, ultrasound, MR, and/or FDG PET-CT scanning. The~     investigators will then compare findings to determine if this radiotracer is worthy of~     further study in a more comprehensive experiment.~   "
145730|NCT01659632|"~     Most of the early gastric cancer are asymptomatic. Symptoms of advanced gastric cancer are~     weight loss, abdominal pain, nausea, vomiting, anorexia dysphagia, gastrointestinal bleeding.~     Gastric cancer found according to warning symptoms such as gastrointestinal bleeding, weight~     loss usually can not be cured. Therefore, early gastric cancer can not be detected and~     impossible to treatment if endoscopy is performed according to the warning signs. National~     gastric cancer screening is conducted in men and women of more than 40 years old. The purpose~     of screening for gastric cancer is discovering a case of possible cure, so increasing the~     survival rate. The purpose of this study is review of the feasibility of screening for~     gastric cancer.~   "
145731|NCT01659619|"~     Erythromycin has a prokinetic effect through Motilin receptor. It evokes migrating motor~     complex with longer and stronger contraction.~      In patients with upper gastrointestinal bleeding, It has been shown that erythromycin could~     clear the stomach of blood, so visual examination could be improved.~      Frequent food stasis is encounted when we examine patients with subtotal gastrectomy. It is~     postulated that erythromycin reduce food stasis and help to improve endoscopy in these cases.~   "
145732|NCT01659606|"~     Dyskeratosis congenita is a disease that affects numerous parts of the body, most typically~     causing failure of the blood system. Lung disease, liver disease and cancer are other~     frequent causes of illness and death. Bone marrow transplantation (BMT) can cure the blood~     system but can make the lung and liver disease and risk of cancer worse, because of DNA~     damaging agents such as alkylators and radiation that are typically used in the procedure.~     Based on the biology of DC, we hypothesize that it may be possible to avoid these DNA~     damaging agents in patients with DC, and still have a successful BMT. In this protocol we~     will test whether a regimen that avoids DNA alkylators and radiation can permit successful~     BMT without compromising survival in patients with DC.~   "
145733|NCT01659593|"~     Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the~     disease. They effect personal life. Their management may be overlooked. The evidence-based~     program proposes exercises to both stimulate preserved functions and develop new abilities~     compensating for cognitive disabilities.~      Aim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed~     for MS patients, compared to an interactive discussion program(DISINT) 140 multiple sclerosis~     patients will be randomly assigned in one the program for 13 sessions over a 6-month period.~      Main outcome criteria is evolution of SRT-LIST before and after program.~   "
145734|NCT01659580|"~     This phase III study is designed as a double blind, randomized, multi-nation, multi-center,~     placebo controlled clinical research, which aims to evaluate the safety and efficacy of~     Dantonic® (T89) in patients with chronic stable angina pectoris.~   "
145735|NCT01659567|"~     This prospective observational study will investigate predictive values of virological~     response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive~     participants with chronic hepatitis C. Participants will be treated with pegylated interferon~     alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of~     96 weeks.~   "
145736|NCT01659554|"~     The primary objective of this study is to investigate the feasibility, tolerability and~     safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC)~     followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary~     peritoneal, and fallopian tube carcinomas.~   "
145737|NCT01659541|"~     The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire~     leads, to produce an effective cough in patients with spinal cord injuries.~   "
145738|NCT01659528|"~     The purpose of this study is to establish nomograms of penile length and width throughout the~     weeks of pregnancy.~   "
145739|NCT01659515|"~     The primary purpose of this protocol is to make arbekacin available for treatment of patients~     with infections caused by multidrug-resistant organisms when treatment with other antibiotics~     cannot be used due to unavailability, intolerance, contraindications, or treatment~     non-response.~   "
145740|NCT01659502|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of TL-118~     alone or in combination with pancreatic cancer chemotherapy.~   "
145741|NCT01659489|"~     Adnexal torsion , is a severe, though uncommon gynecological emergency, with a prevalence of~     2.7-3%. The need for prompt diagnosis and treatment in order to save ovarian tissue has been~     realized a long time ago. A marker that will aid in the diagnosis of torsion and prevent~     missed diagnosis and unecessary loss of ovarian tissue, while not increasing the rate of~     unecessary laparoscopic interventions is much needed. To our knowledge, such marker has not~     been found. The purpose of this study is to find a marker using blood/serum from patients~     undergoing laparoscopy for suspected ovarian torsion~   "
145949|NCT01656746|"~     This study is being done to evaluate single incision laparoscopic surgery (SILS) for~     colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended~     to standardize the SILS technique for colorectal diseases~   "
145742|NCT01659476|"~     The objectives of this research are to compare (i) the bronchodilating and (ii) the~     bronchoprotective effects of deep inspirations (DIs) in individuals with: (a) asthma, (b)~     CVA, (c) methacholine-induced cough but normal airway sensitivity and .~      (d) in healthy individuals (without asthma, chronic cough or asymptomatic airway~     hyperresponsiveness).~      Hypotheses:~      i. The bronchodilating effect of a DI will be: (a) absent or impaired in individuals with~     classic asthma; (b) impaired in individuals with CVA; (c) preserved in individuals with~     methacholine-induced cough but normal airway sensitivity; and (d) preserved in healthy~     individuals (without asthma, chronic cough or asymptomatic airway hyperresponsiveness).~      ii. The bronchoprotective effect of a DI will be: (a) absent in individuals with classic~     asthma; (b) impaired in individuals with CVA; (c) preserved in those with~     methacholine-induced cough but normal airway sensitivity; and (d) preserved in healthy~     individuals (without asthma, chronic cough or asymptomatic airway hyperresponsiveness).~      iii. Healthy individuals without asthma, chronic cough, or asymptomatic airway~     hyperresponsiveness, will not cough, or develop significant dyspnea, small airways~     obstruction or dynamic hyperinflation during high-dose methacholine bronchoprovocation.~   "
145743|NCT01659463|"~     Material for caries prevention dont have better results compared with non-operatory~     interventions.~   "
145744|NCT01659450|"~     Investigators presumed that low energy density (LED) diet consumers will have lower risk of~     cardiovascular disease and are able to maintain their weight longer .~   "
145745|NCT01659437|"~     This is a WHO-sponsored trial.~      Combination therapy with streptomycin and rifampicin has been the standard antibiotic~     treatment for M. ulcerans infection since 2004. In March 2010, a WHO Technical Advisory Group~     recommended that a trial be carried out to develop a fully oral treatment for the disease.~     Although the current treatment is effective, injection with streptomycin is a problem.~     Several small observational studies (published and unpublished) have shown that a fully oral~     treatment is promising.~      This WHO sponsored study will be a randomized, controlled open label non-inferiority phase~     II/III, multi-centre trial (1 centre in Benin and 4 centres in Ghana), with two parallel~     treatment groups. The ultimate goal is to search for an effective alternative treatment to~     the current standard WHO-recommended therapy for all forms of Buruli ulcer, which includes~     injections of streptomycin with inherent logistic, operational and safety disadvantages.~      Financial and material support:~        1. American Leprosy Missions, USA~        2. Raoul Follereau Foundation, France~        3. MAP International, USA~        4. Sanofi, France~        5. 7th Framework Programme of the European Union: BuruliVac project (241500)~        6. Aranz Medical Limited, New Zealand~   "
145746|NCT01659424|"~     Standard treatment for rectum cancer is a pre-surgery course of external beam radiotherapy~     given with chemotherapy at the same time. External beam radiation can increase side effects~     both short and long-term by exposing normal tissue nearby the tumor such as the bladder,~     bowel and sexual organs. Instead, this study will use a different way of delivering radiation~     called brachytherapy to decrease normal tissue radiation exposure. Patient will be given~     three chemotherapy medications both before and after surgery: oxaliplatin (also called~     EloxatinTM) in combination with 5-fluorouracil (5-FU) and leucovorin (also called Folinic~     Acid).~      The purpose of this study is to find out whether giving chemotherapy and brachytherapy before~     surgery can: 1) enable patient's surgeon to successfully remove tumor 2) lower the risk of~     tumor recurrence 3) avoid patient having the side effects related to chemotherapy and~     external beam radiation therapy and 4) improve patient's ability to complete chemotherapy.~   "
145747|NCT01659411|"~     Multi-center, observational, U.S.-based longitudinal program. Data will be collected~     prospectively for 3 years. Individual physician feedback will be provided on data collected~     with the purpose of improving the management of patients - quality enhancement research~     initiative (QuERI) process from adult patients enrolled with a history of repaired Congenital~     Heart Disease (CHD).~   "
145748|NCT01659398|"~     The aim of this study is to investigate whether enhanced external counterpulsation (EECP)~     therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time~     enhance or slow down breakdown of cognitive function in patients diagnosed with mild~     cognitive impairment (MCI).~   "
145749|NCT01659385|"~     The purpose of this study is to evaluate Leptin levels in females, in the setting of~     papillary thyroid cancer, benign thyroid nodules, and in normal females without thyroid~     disease.~   "
145750|NCT01659372|"~     tempromandibuar disorders are a group of heterogenous pathologies affecting temporomandibular~     joint,muscles or both.in more than 90%of cases muscles are the origin of pain.TMDs cause~     pain,movement disability and deficit in quality of life.in more than 90%of cases pain is the~     major complaint.we run this investigation to find the analgesic effct of low level laser~     therapy versus pharmacotherapy with naproxen in improving pain.~   "
145751|NCT01659359|"~     In recent studies using virtual reality has been proposed as a non pharmacological methods~     for pain relief but until this time , its effects has not been assessed on pain and anxiety~     during episiotomy repair. To determine the effectiveness of virtual reality Glasses on pain~     and anxiety in Primiparity women during episiotomy repair.~   "
145752|NCT01659346|"~     Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be~     screened for presence of large esophageal varices and will be randomized between~     non-selective beta blocker versus primary endoscopic variceal ligation. They will be followed~     to assess the rate of reduction of index bleed rate as well as survival difference between~     the groups.~   "
145753|NCT01659333|"~     Dry weight (DW) assessment is essential for the efficient treatment of peritoneal dialysis~     (PD) patients but so far objective methods for DW assessment have not been established for~     daily clinical practice. Our aim was to evaluate hydration state in PD patients by using a~     body composition monitor (BCM) and calf bioimpedance (c-BI) and N-terminal prohormone of~     brain natriuretic peptide (NT-proBNP) levels and to compare both methods with arterial~     stiffness.~   "
145771|NCT01659099|"~     This study is designed to investigate:~        -  the interest of a new monoclonal antibody (GA101)versus rituximab~        -  the interest of PET to identify early responders~      Patients will receive either rituximab (standard treatment), either GA101 (study treatment),~     according to the randomization arm.~      The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to~     site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and~     after 4 chemotherapy cycles, to identify early patients responders, for who consolidation~     with ASCT is not required.~   "
145754|NCT01659320|"~     This research study will examine whether elderly depressed patients whose depressive symptoms~     do not respond satisfactorily to therapy with a mood stabilizer or antidepressant alone gain~     any benefit from taking minocycline alone or in addition to their antidepressant or mood~     stabilizer medication. Minocycline is a commonly used antibiotic medication with~     anti-inflammatory properties. It is hoped that information gained from this study will help~     the investigators better understand the role of inflammation in depression, and whether~     decreasing inflammation will lead to improvement in the symptoms of depression and cognitive~     function.~   "
145755|NCT01659307|"~     This is a double-blind, placebo-controled, randomized trial to investigate if aspirin~     pre-treatment has anti-inflammatory effects in a model of acute lung injury induced by~     inhaled endotoxin (LPS) in healthy human volunteers.~   "
145756|NCT01659294|"~     This study will examine whether patients with diabetes who are either 1) newly discharged~     from hospital or 2) referred to an endocrinologist for management will have better diabetes~     outcomes when their care is managed primarily by a dedicated case manager (intervention) than~     by an endocrinologist (standard care) after 6 months of treatment.~   "
145757|NCT01659281|"~     The main purpose of this study is to compare artesunate-mefloquine combination therapy given~     for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum~     malaria.~   "
145758|NCT01659268|"~     The purpose of this study is to compare if there difference in acquisition of knowledge and~     skills in airway management to baccalaureate nursing students submitted to different learning~     strategies: exhibition-dialogued class and practical activity in skill lab with low-fidelity~     mannequin or simulation class with low-fidelity mannequin.~   "
145759|NCT01659255|"~     This is an open-label, multi-center, phase I dose-escalation study to investigate the safety~     and tolerability of ONO/GS-4059 given as monotherapy to patients with relapsed/refractory NHL~     and CLL.~   "
145760|NCT01659242|"~     In rheumatoid arthritis patients with active disease despite optimal treatment with~     methotrexate, the main objective of this pilot study is to use advance imaging tools such as~     magnetic resonance imaging and ultrasound to evaluate which treatment option is more~     efficacious: initiating methotrexate/sulfasalazine combination therapy, or switching to~     leflunomide monotherapy~   "
145761|NCT01659229|"~     The investigators are comparing the range of movements the knees of patients who had total~     knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a~     Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee~     system designed to combine function with wear resistance. It can accommodate up to 150~     degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which~     can accommodate up to 120 degrees of flexion.~   "
145762|NCT01659216|"~     The purpose of this study is to determine whether electrical pudendal nerve stimulation with~     acupuncture needles as electrodes has a good long-term therapeutic effect on the~     urgency-frequency syndrome in women.~   "
145763|NCT01659203|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational intervention. Phase I studies also try to define the appropriate dose of~     the investigational therapy to use for further studies. Investigational means that the~     intervention is still being studied and that research doctors are trying to find out more~     about it.~      Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen.~     Typically, patients with retroperitoneal sarcomas either have surgery for the removal of~     their tumors alone, or have their tumors removed, followed by standard radiation therapy, or~     have pre-operative radiation followed by surgery. When conventional radiation therapy is~     delivered after surgery, it can damage normal tissue. In this study, you will undergo proton~     beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor.~      Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny~     particles with positive charge that can be controlled to travel a certain distance and stop~     inside the body. In theory, this allows better control of where the radiation dose is~     delivered as compared to photons. Since proton radiation is more targeted, it may help to~     reduce unwanted side effects from radiation.~      In this study, a standard dose of radiation will be given to the majority of the tumor, while~     a simultaneously integrated boost of additional radiation will be given to certain areas of~     the tumor identified as higher risk. This means that a higher radiation dose will be given to~     the higher risk areas of the tumor.~      The purpose of this study is to determine the highest dose of radiation therapy with protons~     or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the~     effectiveness of proton beam radiation therapy as an intervention for patients with~     retroperitoneal sarcomas.~   "
145764|NCT01659190|"~     Urinary infection is one of the most common bacterial infections in pediatrics and requires~     urine collections to be diagnosed. In France, among children under 3, urine samples are~     collected thanks to collecting bags.~      Work teams have set as their main goal to compare the different levels of acute pain involved~     for children under 3 during the removing of the collecting bag, depending on the use, or not,~     of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a main~     endpoint, the difference between the results assigned to the acute pain by a pain evaluation~     scale (FLACC: Face-Legs-Activity-Cry-Consolability).~   "
145765|NCT01659177|"~     The study will evaluate the effect of food on absorption of LY2140023 in blood. This study~     involves a single dose of 80 mg LY2140023 taken as a tablet by mouth on 2 occasions, once on~     an empty stomach and once after eating breakfast. There is a minimum 3 day washout between~     doses. This study will last approximately 16 days not including screening. Screening is~     required within 30 days prior to the start of the study.~   "
145766|NCT01659164|"~     The purpose of this uncontrolled pilot study is to develop and make an initial evaluation of~     a new treatment manual for treatment of ADHD in adults. The objectives in the treatment is to~     build relational skills, skills in organizing and structuring everyday life, handle difficult~     emotions and impulses etc. The treatment will be in a group format and it is hypothesized~     that the psychological intervention will result in reduced ADHD symptoms and to decreased~     experience of stress and depressive symptoms. The uncontrolled design does not allow for any~     causal inferences from the results, this pilot study is primarily to be seen as a preparation~     before a subsequent RCT.~   "
145767|NCT01659151|"~     The purpose of this study is to find out more about the effects of an investigational~     combination of medicines, which includes special immune cells (T-cells).~      A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes are a kind of white blood~     cell that protect the body from viral infections, help other cells fight bacterial and fungal~     infections, produce antibodies, fight cancers, and coordinate the activities of other cells~     in the immune system.~   "
145768|NCT01659138|"~     Primary Objective:~      To assess the efficacy of SAR339658~      Secondary Objective:~      To assess the safety of SAR339658~   "
145769|NCT01659125|"~     The primary aim of this study is to learn about who is most likely to benefit from guided~     self-help (GSH) for obsessive-compulsive disorder (OCD).~   "
145779|NCT01658995|"~     This is a double-blinded, randomized, prospective placebo-controlled clinical trial to be~     conducted within the Mayo Clinic and the Mayo Clinic Health System.~      The goal of the research study is to gather information to determine whether Doxycycline is~     effective for the treatment of unacceptable bleeding associated with the etonogestrel~     subdermal implant (ESI), as compared to placebo.~   "
145780|NCT01658982|"~     Optimizing patient survival and organ utility is a constant struggle for the liver transplant~     community. Despite rigorous cardiovascular evaluation before liver transplantation~     cardiovascular events are one of the leading causes of post-transplant morbidity and~     mortality in both early and late post transplant periods. Poor performance on measures of~     cardiopulmonary fitness has been associated with worse outcomes in liver transplant~     candidates. The investigators seek to determine the feasibility of obtaining measures of~     cardiopulmonary performance in liver transplant candidates from standard cardiopulmonary~     exercise testing (CPET) and from a modified 3 minute step test and to determine whether the 3~     minute step test is suitable for the assessment of cardiopulmonary fitness in a future~     outcome study.~   "
145781|NCT01658956|"~     The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile~     neutropenia among patients with breast cancer, treated with chemotherapy and presenting with~     a low to moderate risk of developing febrile neutropenia.~   "
145782|NCT01658943|"~     This randomized phase II trial studies how well selumetinib and Akt inhibitor MK2206 work~     compared to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) therapy in~     treating patients with metastatic pancreatic cancer previously treated with chemotherapy.~     Selumetinib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet know whether selumetinib and Akt~     inhibitor MK2206 are more effective than oxaliplatin and fluorouracil in treating patients~     with metastatic pancreatic cancer.~   "
145783|NCT01658930|"~     The reason this study is being done is to see if a simple hysterectomy is as good as a~     radical hysterectomy in preventing cancer of the cervix from returning, and whether, because~     less tissue surrounding the uterus is removed during surgery, there are fewer side-effects~     after the surgery and in the long-term.~   "
145784|NCT01658917|"~     Background:~      The NCI Surgery Branch has developed experimental therapies that involve taking white blood~     cells from patients' tumor or from their blood, growing them in the laboratory in large~     numbers, and then giving the cells back to the patient.~      Objective:~      This study will allow tissue samples obtained during the protocol screening process to be~     used for future and ongoing research in the NCI Surgery Branch~      Eligibility:~      Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment~     Protocol~      Design~      Patients will undergo testing and evaluations as required by the appropriate NCI Surgery~     Branch Treatment protocol~   "
145785|NCT01658904|"~     Background:~      - Plasma cell myeloma is a type of cancer that affects the plasma cells in the bone marrow.~     It can be difficult to treat with chemotherapy. One possible treatment combines chemotherapy~     with a stem cell transplant. To make this treatment more effective, researchers want to give~     another drug along with the transplant. This drug, carfilzomib, is often used to help treat~     plasma cell myeloma. However, it is not usually given along with the transplant. Researchers~     want to see if it is safe and effective to combine the stem cell transplant with carfilzomib,~     and if it improves the results of the transplant.~      Objectives:~      - To test the safety and effectiveness of carfilzomib given with stem cell transplant for~     plasma cell myeloma.~      Eligibility:~      - Individuals between 18 and 75 years of age who are having a stem cell transplant to treat~     plasma cell myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and a bone marrow biopsy will also be~          performed.~        -  Participants will have their own stem cells collected for the transplant. The transplant~          will be performed according to the standard of care.~        -  All participants will receive carfilzomib on the first 2 days after transplant. The~          study doctors will determine the number of additional doses that they may have.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~   "
145786|NCT01658891|"~     single center, double-blind, double-dummy, 2-way cross over study in asthmatic children~     already treated with inhaled corticosteroids~   "
145787|NCT01658878|"~     The first part of the study is the Dose Escalation Phase designed to establish the safety of~     nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular~     carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B~     virus (HBV)-infected subjects).~      The second part of the study is the Expansion Phase designed to generate additional clinical~     data at specified doses for each of the 3 cohorts. A third cohort has been added in this~     study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A~     fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus~     ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data~     will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added~     to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and~     nivolumab with ipilimumab in combination with cabozantinib.~   "
145788|NCT01658865|"~     The purpose of this study is to assese esophageal motor function by simplified transnasal~     endoscopy compared with esophageal manometry.~   "
145789|NCT01658852|"~     Recent study showed that SIBO is common among postgastrectomy patients and It appears to be~     associated with postprandial intestinal symptoms and might aggravate late hypoglycemia. SIBO~     could be a new therapeutic target for managing intestinal symptoms in postgastrectomy~     patients.The purpose of this study is to determine whether antiboitic (metronidazole) is~     effective in patients with postgasrectomy syndrome~   "
145790|NCT01658839|"~     The purpose of this study was to assess the safety and describe the steady-state plasma~     pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation)~     following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension~     patients.~   "
145791|NCT01658826|"~     The aim of the study is to evaluate the safety and efficacy of AIC316 (pritelivir) 100 mg~     once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital~     shedding.~   "
145793|NCT01658800|"~     The purpose of this study is to test an investigational vaccine known as VAX161C. An~     investigational vaccine is one that is not licensed for commercial use in the by the United~     States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for the~     influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject~     will receive the VAX161C vaccine at one of six doses to see which dose is the best. VaxInnate~     wants to find out how safe these doses of vaccines are and how well they are tolerated by~     people who receive them. To measure how effective each type of the vaccine is, VaxInnate will~     test the ability of the body to develop an immune response, which means how the body~     recognizes and defends itself against the influenza virus.~   "
145794|NCT01658787|"~     Prospective, observational Registry to obtain data on device performance and clinical~     outcomes.~   "
145795|NCT01658774|"~     Many school children in Kenya are infected with plasmodia and helminth species and are at~     risk of coinfection. It has been suggested that the immune response evoked by helminth~     infections may modify immune responses to plasmodia species and consequently alter infection~     and disease risks. However, studies conducted to date have been typically cross-sectional and~     produced conflicting results, and there is a need for longitudinal studies to better~     understand the clinical consequences for individuals harbouring coinfection. This study aims~     to investigate the impact of intensive (once every 3 months) anthelminthic treatment versus~     annual treatment on the risk of clinical malaria and on immune responses among school~     children aged 5-14 years in Western Province. Specifically, this study aims to investigate~     the impact of intensive anthelminthic treatment on (i) the incidence of clinical malaria in~     school children, assessed using active case detection; (ii) the prevalence and density of~     Plasmodium spp. infection, using repeat cross-sectional surveys; and (iii) malaria and~     helminth specific immune responses. The study hypothesis is that intensive anthelminthic~     treatment among children infected with either Ascaris lumbricoides or hookworm modifies human~     host immune responses to plasmodia and helminth infections, and therefore alters the risk of~     Plasmodium infection and clinical disease.~      This individually randomised trial will recruit 1,450 children aged 5-14 years found to be~     infected with either Ascaris lumbricoides or hookworm species. Recruited children will be~     randomized to receive albendazole treatment either every three months or annually and~     monitored through periodic surveillance for clinical malaria episodes over 18 months. In~     addition, blood samples will be collected from sub-sample of children and screened for~     malaria specific immunoglobulin (Ig)G1 and IgG3 and helminth specific IgE, IgG2, IgG4 and~     IgM. Cell culture supernatants will be assayed for interferon (IFN)-γ, tumor necrosis factor~     (TNF)-α, interleukin (IL)-10, IL-5, IL-4 and IL-2.~   "
145796|NCT01658761|"~     Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was~     evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it~     may improve visual outcome.~   "
145797|NCT01658748|"~     The purpose of this study is to determine whether deep brain stimulation of the basolateral~     nucleus (BLn) of the amygdala, on both sides of the brain, can safely reduce symptoms of~     post-traumatic stress disorder (PTSD) in combat veterans whose condition has not improved~     despite extensive treatment with currently available medication and psychotherapy~     interventions.~   "
145798|NCT01658735|"~     The intent of this project is to execute a high-quality double-blinded randomized controlled~     clinical trial that compares the H-Wave® device with a commonly used TENS device with a~     sub-therapeutic electrocurrent device. This study will provide a definable level of evidence~     for treatment efficacy, and provide a basis for evidence-based recommendation for or against~     utilization for these two modalities. The results for H-Wave® device, if positive, could~     significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for~     symptomatic relief, and reduce overall disability and health care costs associated with~     chronic low back pain.~   "
145799|NCT01658722|"~     A Phase 3b, Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in~     Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies~     ELN115727-301 and 302 but did not Enroll in Study ELN115727-351.~   "
145800|NCT01658709|"~     The objective of this study is to determine if a clinical measure can be used effectively to~     predict ankle injury in high school and collegiate athletes across a variety of sports.~      Hypothesis: For each ankle injury category (lateral ankle sprain, medial ankle sprain,~     syndesmosis ankle sprain, Achilles rupture, fracture) participants that suffer these injuries~     will have a significantly lower SEBT normalized composite score and FMS composite score~     compared to those participants that do not suffer the injury~      Hypothesis #1b: Similar to a previous study examining high school basketball players22, using~     receiver operator characteristic (ROC) curves, we will be able to calculate likelihood~     ratios, odds ratios, sensitivity and specificity and determine the ideal cut-off point of the~     SEBT normalized composite score and FMS composite score that will be able to predict the risk~     of each ankle injury category (lateral ankle sprain, medial ankle sprain, syndesmosis ankle~     sprain, Achilles rupture, fracture).~      Athletes from identified sites will perform measures of the star excursion balance test~     (SEBT) and the Functional Movement Screen FMS before the first day of practice. During the~     competition season, the number of practice and competition person exposures, as well as the~     number of ankle injuries, will be recorded. The rate of ankle injuries/exposure will be~     calculated and compared with the pre-season SEBT scores to create a simple and a complex~     prediction model for risk of ankle injury~   "
145801|NCT01658696|"~     Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials become~     more widely available. However, transmission still persists and it appears that additional~     control measures are required. The leading malaria vaccine candidate in development is RTS,S~     which has efficacy against clinical malaria measured at 30-50% in the field. This partial~     protection might be enhanced by combination with other components. The other vaccination~     approach that has produced repeatable efficacy in humans is the use of viral vectors to~     induce T cell responses. Previous attempts with this vaccine approach have been effective in~     challenge studies in Oxford, but ineffective in the field, probably because of reduced~     immunogenicity with previous vector platforms.~      Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity~     by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified~     vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with~     thrombospondin- related adhesion protein (ME-TRAP).~      The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and~     partial protection in 5 out of 14 volunteers in challenge studies.~      The investigators propose a Phase 2b study of 120 healthy adult men in Senegal. The~     investigators will assess the efficacy and further evaluate the immunogenicity and safety~     profile of the vaccine regimen. The investigators also intend to assess the correlates of~     efficacy and natural immunity.~   "
145823|NCT01658397|"~     In this study, we will be studying the effects of acute calorie deprivation (a 10-day fast)~     on bone marrow fat, other fat stores and bone parameters. We will be measuring changes in~     bone marrow fat using magnetic resonance spectroscopy and will use MRI to measure~     subcutaneous and visceral fat depots. Our hypothesis is that levels of bone marrow fat will~     increase after an acute fast.~   "
145802|NCT01658683|"~     The purpose of this study is to develop a new intervention to improve the transition of~     patients from structured, supervised exercise to self-managed home- or approved~     community-based exercise programs in an effort to increase maintenance of exercise behaviour~     post cardiac rehabilitation (CR). The goal of the study is that those receiving the~     intervention will engage in at least 30 minutes of physical activity at a moderate or~     vigorous intensity 5 or more days per week, 26, 52 and 78 weeks after CR compared to those in~     the usual care group. The new intervention will be delivered by trained exercise facilitators~     (physiotherapists or exercise specialists) and will make use of: small group counseling~     teleconferences (5 sessions); personal telephone contacts (3 sessions), and community program~     demonstrations that would facilitate linkages between patients and approved community~     programs known as Heart Wise Exercise programs available in Ottawa and Toronto. The trial~     will be conducted at the Minto Prevention and Rehabilitation Centre at the University of~     Ottawa Heart Institute and the Cardiovascular Rehabilitation and Prevention Centre at the~     University Health Network (Peter Munk Cardiac Centre [PMCC] and Toronto Rehabilitation~     Institute [TRI]) sites. The study has a target enrollment of 604 participants.~   "
145803|NCT01658670|"~     The purpose of this study is to determine the efficacy of the Heart Failure Exercise and~     Resistance Training (HEART) Camp behavioral exercise training intervention on long-term~     adherence to exercise at 18 months in patients with heart failure. The central hypothesis is~     that the HEART Camp intervention group (HC) will have significantly better adherence to~     exercise at 18 months.~   "
145804|NCT01658657|"~     The purpose of this study is to investigate the effect of plasma renin activity-guided~     therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that~     can be measured to determine your hypertension subtype. Once the subtype is known, doctors~     can prescribe specific medications to target your specific hypertension subtype. This study~     will investigate whether targeting the specific hypertension subtype helps to achieve blood~     pressure control sooner and with fewer medications compared to a standard fixed dose~     combination therapy.~   "
145805|NCT01658644|"~     Communication is critical within healthcare, and is the root cause of most errors. With~     increased adoption and use of new information technologies and mediated communication~     systems, such as Electronic Health Records (EHR), that support visual content, hospitals can~     begin to look at the potential of photographic aids to improve patient satisfaction,~     clinician communication, and ultimately quality of care. Having pictures of clinicians and~     patients may improve communication by improving knowledge of who is part of the care team and~     may reduce electronic ordering or documentation on the wrong patient.~      Despite the importance of communication between clinicians and the many advances within~     information and communication technologies, there is a lack of literature documenting systems~     that are effective at improving communication. Our research study will provide an overview on~     the communication models and technologies used in Canadian hospitals and add insights to the~     impacts of these technological adoption.~      Research Question: How does the use of photographic influence patients' hospital experience?~      Specifically, do photographic aids (photographs of clinicians' faces) influence:~        1. Patient's ability to identify their clinical care team members~        2. Patient's ability to identify their care team members and know their individual roles~        3. Patient's satisfaction with their hospital experience~   "
145806|NCT01658631|"~     The purpose of this study is to compare the non invasive measurement of arterial pressure~     (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)~        -  during induction of general anesthesia,~        -  during a leg raising test in the Intensive Care Unit~   "
145807|NCT01658618|"~     This observations safety study is intended for subject who participated in the 802-247-09-029~     study with the investigational product HP802-247 for venous leg ulcers and received at least~     one application of HP802-247 or Vehicle (an inactive substance). This study is being done for~     the following purposes:~        1. to identify new adverse events,~        2. to examine ongoing adverse events not resolved in subjects who participated in the~          802-247-09-029 trial,~        3. to record wound status, and~        4. to determine if there are differences in Health Related Quality of Life (HRQoL)~          associated with the treatment assignment from the 802-247-09-029 Trial.~      Investigational means that HP802-247 has not been approved by the U.S. Food and Drug~     Administration (FDA).~   "
145808|NCT01658605|"~     GSK1605786 is an oral antagonist specific for the chemokine receptor CCR9 in development for~     treatment of small bowel and colonic Crohn's disease (CD). The purpose of this Phase II proof~     of concept study is to investigate the efficacy and safety of GSK1605786 (500 mg twice daily)~     administered orally for 16 weeks for the treatment of patients with active ulcerative colitis~     (UC). A key secondary objective is to understand the mechanism by which GSK1605786 is acting~     and to this end samples will be collected to confirm the degree of inhibition of CCR9 on T~     lymphocytes in the blood of patients, and to explore the relationship between concentration~     of drug and changes in lymphocyte and antigen presenting cell populations in the peripheral~     circulation and in the colon. Patients recruited at specified investigational sites will be~     invited to participate in an optional sub-study to explore the effects of GSK1605786 on~     trafficking of technetium labelled T cells using Single Photon Emission Computerized~     Tomography (SPECT). Specifically, the technique will be used to follow trafficking to large~     intestine and thymus and findings linked to pharmacokinetics of GSK1605786, receptor~     occupancy and clinical efficacy outcomes~   "
145809|NCT01658592|"~     The main objective of this study is to assess the efficacy of bilateral deep brain~     stimulation (DBS) of the nucleus accumbens (NAc) and the ventral anterior internal capsule~     (VC) as a novel treatment in severe alcohol addiction. The included patients have been~     treated so far with drugs that inhibits alcohol, or psychological behavior training.~      Our hypothesis is that bilateral NAc-VC DBS will significantly reduce the craving for alcohol~     and thus enable the patients to decrease their alcohol intake substantially.~   "
145810|NCT01658579|"~     Primary Objective:~        -  To compare the glucose control during treatment with a new formulation of insulin~          glargine and Lantus in adult participants with type 1 diabetes mellitus~      Secondary Objectives:~        -  To compare a new formulation of insulin glargine and Lantus given in the morning or in~          the evening~        -  To compare the incidence and frequency of hypoglycemic episodes~        -  To assess the safety and tolerability of the new formulation of insulin glargine~   "
145811|NCT01658553|"~     A multicenter, non-randomized, placebo-controlled, single dosing schedule, subject-blinded~     study to evaluate the effect of GSK1120212 on the electrical activity of the heart as~     compared to placebo in subjects with solid tumor cancers. All subjects will undergo Screening~     assessments within 21 days prior to the start of the study treatment to determine their~     eligibility for enrollment in the study. Eligible subjects will receive study treatment~     administered over a period of 15 days followed by a post-treatment follow-up visit. Study~     treatment (GSK1120212-matched placebo) will be blinded to subjects. Subjects will receive~     GSK1120212-matched placebo on one day during the first 14 days of dosing. On all other days~     the subject will receive a once-daily 2 mg dose of GSK1120212 except for Day 15 when the~     subject will receive 3mg dose of GSK1120212 12-lead ECG recordings will be obtained from~     continuous ECG recordings obtained via a 12-lead Holter monitor on Study Days 1 and 15 while~     subjects are in the clinical research unit. The effect of GSK1120212 on the electrical~     activity of the heart will be determined by time-matched ECGs obtained at the same time~     points relative to dosing on these days. Ambulatory blood pressure readings will be obtained~     from continuous 24-hour recordings via an ambulatory blood pressure monitor The effect of~     GSK1120212 on blood pressure parameters will be determined by blood pressure readings~     obtained at the same time points relative to dosing on Study Days 1 and 15. Serial blood~     samples to analyze the concentration of study drug in the subject's blood will be obtained at~     the same time points relative to dosing on Study Days 1 and 15. Subjects who are eligible for~     continued treatment with GSK1120212 may continue treatment under the rollover study MEK114375~     (drug study number). A post-treatment follow-up visit will be conducted within 28 days of the~     last dose of study treatment for all subjects who do not continue treatment in the rollover~     study MEK114375.~   "
145812|NCT01658540|"~     The primary purpose of this study is to assess safety and efficacy of the Drug Eluting~     Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic~     obstructive vascular disease in patients presenting with long lesions. As secondary aim this~     study is going to explore treatment effect on a number of procedural and clinical endpoints~     in order to collect information to design a future comparative effectiveness study.~   "
145813|NCT01658527|"~     The objective of this randomized phase II open label trial is to determine the anti-tumor~     activity of TAK-700 (Orteronel) as compared to bicalutamide in terms of clinical~     progression-free survival in prostate cancer patients who failed 1st line treatment with LHRH~     (luteinizing hormone-releasing hormone) agonists or surgical castration.~   "
145814|NCT01658514|"~     This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in~     subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction,~     or severe kidney dysfunction. The safety and tolerability of Met DR was also examined. In~     addition, this study compared the behavior of a single dose of Met DR with that of~     extended-release metformin (Met XR) and placebo in subjects with the varying levels of kidney~     function described above.~   "
145815|NCT01658501|"~     Primary objective:~      The primary objective of this study is to define the dose response of Glymera as measured as~     the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.~      Secondary objectives:~      The secondary objectives are to:~        -  Describe incidence, severity, and duration of reported gastrointestinal side effects of~          Glymera compared to active comparator;~        -  Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo~          and active comparator;~        -  Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of~          dosing compared to placebo and active comparator;~        -  Describe the frequencies of adverse events in the treatment groups; and~        -  Describe the above endpoints for the following subgroups of subjects according to~          baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin~          only, sulfonylurea only, or metformin and sulfonylurea combination therapy.~   "
145816|NCT01658488|"~     The purpose of this study is to see if rice enriched in iron will help women with~     iron-deficient anemia restore their blood counts more efficiently than the standard rice not~     enriched with iron.~   "
145817|NCT01658475|"~     This study was performed to evaluate prospectively the diagnostic utility of a blood IgG~     antibody titer test against periodontal pathogens.~   "
145818|NCT01658462|"~     National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy /~     Second-line chemotherapy for locally recurrent or metastatic breast cancer.~   "
145819|NCT01658449|"~     The purpose of this study is to compare the tolerability and acceptability of a formulation~     containing Hypertonic saline 7% (HS) alone and a formulation containing HS and Hyaluronic~     acid 0.1% in a population of Cystic Fibrosis (CF) patients who already showed poor tolerance~     to HS.~   "
145820|NCT01658436|"~     This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC)~     versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET)~     after failure of mTOR inhibitor therapy.~      Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single~     arm, open label design and Stage 2 was planned to be a randomized, double-blind study.~      However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.~   "
145821|NCT01658423|"~     The current study examined the effect of maturity on the sprint and jump performances in a~     single year age group of 13 year old boys.~   "
145822|NCT01658410|"~     Background: Although selected cardiac surgery can be performed off-pump, the vast majority of~     cardiac surgical procedures today are performed with the support of cardiopulmonary bypass~     (CPB). Blood cardioplegia is used to protect the heart during aortic cross-clamping. However,~     negative effects of myocardial hypoxia during surgery are often aggravated by~     ischemia/reperfusion injury. In addition, cardiopulmonary bypass leads to an inflammatory~     response including endothelial cell activation.~      Comparable to the reperfusion injury following acute myocardial infarction resolved by~     percutaneous coronary intervention, the microcirculatory impairment observed after cardiac~     surgery may be caused by endothelin 1 (ET-1). ET-1 is a potent vasoconstrictor peptide~     upregulated in myocardial ischemia-reperfusion injury. Short-term administration of the~     selective ETA receptor blocker BQ-123 was found safe in a pilot study including patients with~     acute myocardial infarction.~      Hypothesis: Acute local ETA receptor blockade by intracoronary administered BQ-123 reduces~     myocardial injury.~      Methods: BQ-123 will be administered in patients undergoing on-pump aorto-coronary bypass~     grafting to the left anterior descending coronary artery with the use a left inner mammary~     artery graft and at least one vein graft. Subjects will be randomized to receive the~     endothelin-A receptor blocker BQ-123 or placebo administered intracoronarily in combination~     with cardioplegia in a double-blind manner. The primary endpoint will be enzymatic infarct~     size.~      Clinical perspective: The implementation of BQ-123 as an add-on pharmacologic therapy in~     cardiac surgery performed with the use of cardiopulmonary bypass could lead to improved~     tissue reperfusion and reduced ischemia/reperfusion injury, potentially impacting clinical~     long-term outcome.~   "
145824|NCT01658384|"~     This study is designed to evaluate the effect of Tysabri on cognition in multiple sclerosis~     (MS) patients. During a period of 24 months, the study will assess the evolution of cognitive~     function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and the~     CogState battery of tests.~   "
145826|NCT01658358|"~     Objectives:~      Phase I part~        -  Primary Objective: To determine the recommended dose of the combination of lapatinib~          with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic~          breast cancer.~        -  Secondary Objectives:To define the safety profile; To observe the response rate and~          progression free survival~      Phase II part~        -  Primary Objective :To determined the objective response rate of the combination of~          lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive~          metastatic breast cancer.~        -  Secondary Objectives:To define the safety profile; To determined the progression free~          survival~   "
145827|NCT01658345|"~     Aortic stenosis (AS), or narrowing of the aortic valve, is the commonest condition requiring~     valve surgery in the developed world. It is currently not known what determines who will go~     on to develop symptoms. Exercise testing may be able to identify these patients better than~     the severity of the narrowing itself, but with some limitations.~      The purpose of this study is to compare whether MRI scanning or exercise testing can better~     identify patients with AS who are likely to benefit from surgery.~      Design: The investigators will measure blood flow to the heart muscle with MRI scanning and~     perform exercise testing in 170 patients with AS and follow them for up to up to 2 years.~     Expected outcomes: MRI scanning will more accurately identify those patients with AS who will~     need surgery during this period. Anticipated Health Benefits: improved selection of patients~     with AS who are likely to benefit from early surgery. This is likely to reduce deaths in such~     patients.~   "
145828|NCT01658332|"~     TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer~     (CIRCUBRONCH)~      BACKGROUND : Circulating tumor cells identification is a new field of research in oncology,~     and some studies have been conducted with success on breast and prostate cancer. Nearly 80%~     of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells~     identification and monitoring these cells after treatment could help the clinicians to detect~     relapse or be a prognostic factor.~      PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage~     lung cancers (IIIB and IV).~      SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the~     therapeutic response. Prognostic value of identification of circulating tumor cells at the~     time of diagnosis.~      STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification~     of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.~      Duration of the inclusions: 54 months.~      Duration of the study: 66 months.~      PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a~     cut-off of 5 cells/7,5 ml of blood.~      SAMPLE SIZE : 200 patients~      STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage~     IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating~     tumor cells per 7,5 ml of blood.~   "
145829|NCT01658319|"~     This phase I trial is studying the side effects and best dose of methoxyamine when given~     together with fludarabine phosphate in treating patients with relapsed or refractory~     hematologic malignancies. Drugs used in chemotherapy, such as methoxyamine and fludarabine~     phosphate, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving methoxyamine together with fludarabine~     phosphate may kill more cancer cells.~   "
145830|NCT01658306|"~     The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a~     beneficial effect on outcomes of cerebral small vessel disease (CSV).~   "
145831|NCT01658293|"~     Sensory and/or motor deficits in upper limb following stroke often have negative impacts on~     their daily living. Thermal stimulation with hot and cold pack alternatively incorporated~     into conventional rehabilitation has been reported and proved to be effective for upper limb~     functional recovery after stroke. However, whether hot- and cold-water stimulation~     alternatively based on thermal stimulation also has the effect still remains unknown. The aim~     of present study is to investigate the facilitated effect of hot and cold water stimulation~     alternatively on upper limb after stroke.~   "
145832|NCT01658280|"~     The main purpose of the present study is to assess whether the sensitivity of~     Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of~     conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.~   "
145833|NCT01658267|"~     This study will assess compliance with dietary recommendations, in conjunction with a~     nutritional supplement to meet the nutritional requirements in children and the effects of~     the compliance on promoting growth in children who are at risk of under-nutrition.~   "
145834|NCT01658254|"~     The gap between the high number of registered trials and the few ones where results were~     available (in registries or in journals) has been identified as a major problem distorting~     the scientific evidence available. As a consequence, the FDAAA (Food and Drug Administration~     Amendments Act) added on September 27, 2007 a requirements policy regarding publication of~     summary results on the publicly accessible registry ClinicalTrials.gov. Reporting of summary~     results is required for applicable clinical trials no later than one year after the~     primary completion date, i.e. the date of collection of primary outcome data on the last~     patient to be enrolled. 'Applicable clinical trials', is the term used in the FDAAA to~     designate trials that may be subject to the registration and reporting requirements.~      Not complying with the reporting requirements can result in penalties, such as withholding of~     National Institute of Health grant or funding and civil monetary penalties of up to $10,000 a~     day. Despite the possibility of incurring penalties for not complying with the posting~     requirement, compliance remains globally poor.~      In this current study, the primary objective will be to test the hypothesis that sending an~     email looking as a survey, reminding the necessity of posting results to the trials'~     responsible parties registered in ClinicalTrials.gov and subject to mandatory reporting but~     not complying with it, will increase the results posting rate.~   "
145853|NCT01657994|"~     The purpose of this research study is to learn more about the usefulness of a physical~     therapy treatment that combines robot-assisted walking with electrical impulses that help to~     make muscles contract. This treatment is intended for children with cerebral palsy. Up to~     eleven children with cerebral palsy will receive up to 18 treatments and will have several~     evaluations before and after treatment.~   "
145854|NCT01657981|"~     The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with~     a radio labeled drinking solution.~   "
145835|NCT01658241|"~     This study is looking at the effects of Panobinostat, an investigational treatment, on cancer~     cells in patients who have Hodgkin lymphoma (a cancer of the immune system with specific~     Hodgkin/Reed Sternberg Cells), T-cell lymphoma (a cancer of the immune system with too many T~     lymphocytes), chronic lymphocytic leukemia or prolymphocytic leukaemia (immune system with~     too many lymphocytes in the blood stream), lymphoplasmacytic lymphoma (immune system with too~     many plasma cells or B lymphocytes) or myeloma (a cancer of plasma cells).~      Panobinostat is a new drug which has led to disease improvement in some patients with Hodgkin~     lymphoma, certain types of T-cell lymphoma, myeloma and some B cell lymphomas. Not all~     patients benefit from panobinostat.~      The researchers wish to look at the effects of panobinostat on cancer cells. The aim of this~     project is find out which patients or diseases are likely to respond to treatment with~     panobinostat in the future and to see if there are particular features of the patient or of~     the cancer that affects the likelihood of the way individuals respond to panobinostat.~      Panobinostat is an oral medication (taken by mouth) that effects the way cancer cells and in~     normal cells make proteins. Panobinostat has been used in several clinical trials around the~     world. The largest trials generally have fewer than 200 patients and are in Hodgkin lymphoma,~     cutaneous T-cell lymphoma, and myeloma where between one in five and one in three patients~     have significant improvement in their disease.~      Researchers will look at samples of tumour before treatment and during treatment. This will~     be one of the first studies to look at how cancer cells change following treatment with this~     drug. It is unusual because it requires repeated biopsies of the participant's tumour.~     Panobinostat is considered an experimental (or investigational) drug and not approved by any~     regulatory authority (such as the Food and Drug Administration, FDA in the USA or by the~     Therapeutics Goods and Administration, TGA, in Australia) to treat any type of cancer.~     Therefore, Panobinostat is not approved to treat patients who have been diagnosed with~     refractory or relapsed cancer.~      A total of 30 patients with one of the diseases listed above will be enrolled at Peter~     MacCallum Cancer Centre.~      It is expected it will take about 2 to 3 years to recruit 30 patients and that on average~     patients will take part for six to eighteen months. This time could be shorter or longer~     depending on how well the treatment works in each individual. While the trial will take up to~     4 years to complete, the science studies may take longer.~   "
145836|NCT01658228|"~     Patients presenting with depression (DEP) and cognitive impairment (CI), represent a unique,~     understudied population that is difficult to diagnose, treat and estimate prognosis. Our~     pilot data, supported by the literature, suggest that many DEP-CI patients show cognitive~     decline and often convert to dementia, primarily Alzheimer's disease (AD). In DEP-CI, there~     is a lack of data on treatment response of mood symptoms to antidepressant treatment and~     particularly of cognitive deficits to cognitive enhancer treatment. Our initial pilot data in~     a double-blind study showed that donepezil was superior to placebo in improving memory in~     antidepressant-treated DEP-CI patients. In a second pilot study, open label es-citalopram~     plus memantine treatment led to a low rate of conversion to dementia.~      In this proposed pilot clinical trial, the investigators will evaluate, treat and follow a~     broad sample of 80 DEP-CI patients at NYSPI/Columbia University Medical Center (N = 40) and~     Duke University Medical Center (N = 40). Recruitment will be from clinics and/or~     advertisements. In the treatment protocol, all 80 DEP-CI patients will receive baseline mood~     and memory assessments and open antidepressant treatment with citalopram for 8 weeks. At 8~     weeks, repeat assessment will occur and patients whose depression has responded to citalopram~     will be randomized to add-on donepezil or placebo. Non-responders to citalopram will receive~     open treatment with venlafaxine and will be randomized 8 weeks later (16 weeks of open~     antidepressant treatment) to add-on donepezil or placebo. Patients will be followed for a~     total period of 18 months with continuous open antidepressant treatment during the trial.~      Donepezil is being studied in order to increase the likelihood of obtaining a signal. If the~     results are positive, the investigators can begin clarifying the mechanism(s) in subsequent~     trials. Baseline apolipoprotein E e4 genotype, odor identification deficits, and MRI~     hippocampal and entorhinal cortex atrophy will be explored as predictors of donepezil~     response in the 18-month trial. Improving cognition and delaying conversion to a clinical~     diagnosis of dementia in this high risk group will enhance quality of life, reduce family~     burden, and markedly diminish overall health care costs.~   "
145837|NCT01658215|"~     The purpose of this study is to compare the relative bioavailability of nicotine following~     repeated applications of a new transdermal formulation to that of a reference formulation.~      Up to day 7~   "
145838|NCT01658202|"~     The purpose of this study is to compare the relative bioavailability of nicotine following~     single application of a new transdermal formulation to that of a reference formulation.~      4 single 24hour applications separated by 48hour intervals.~   "
145839|NCT01658176|"~     PF-04691502 is an inhibitor of PI3K and mTOR kinase. Exemestane is an aromatase inhibitor for~     the treatment of advanced breast cancer in women whose disease has progressed following~     tamoxifen therapy. The combination of PF-04691502 and exemestane might mitigate resistance to~     hormonal therapy and result in greater clinical benefit than exemestane alone in women with~     estrogen receptor positive advanced breast cancer.~   "
145840|NCT01658163|"~     The investigators prospectively studied the results of wound closure after abdominoplasty~     with randomized use of PrineoTM and conventional suturing to assess the possible difference~     in outcome between these two methods.Follow-up visits to the outpatient clinic were scheduled~     at 2 weeks, 6 months and 12 months after surgery. A panel consisting of three plastic~     surgeons and three plastic surgery residents assessed the wound and scar appearance during~     the three follow-up visits.~   "
145841|NCT01658150|"~     The purpose of this study is to evaluate the use of the drug isradipine for cognitive~     enhancement in patients diagnosed with schizophrenia and schizoaffective disorder.~   "
145842|NCT01658137|"~     Genetic factors contribute to risk factors for cardiovascular disease, such as blood lipids,~     blood pressure, obesity, diabetes, and may also influence dietary choices, physical activity,~     and responses to stress. The most robust genetic variant associated with myocardial~     infarction (MI) is the 9p21 variant, which may raise the risk of MI by up to 40% in those who~     carry 2 copies of the gene. The investigators recently found that among those who carry the~     9p21 variant, the risk of MI may be turned off if individuals eat a diet high in fruits and~     vegetables. The investigators seek to determine how a prudent or anti-inflammatory diet~     interacts with the 9p21 risk allele to alter the risk of MI.~   "
145843|NCT01658124|"~     Severe bleeding in the digestive system is a common symptom of many diseases. Each year,~     about 50,000 people end up in British hospitals because of this problem and about 5,000 of~     them die. The most common cause of this bleeding is stomach ulcers. In sub-Saharan Africa,~     schistosomiasis (parasitic worms) is responsible for about 130,000 deaths from stomach~     bleeding each year. From previous research in other bleeding conditions such as surgery and~     trauma, we know that a drug called tranexamic acid can reduce bleeding and save lives. We now~     want to do the HALT-IT trial to see if giving tranexamic acid can save lives and if there are~     any complications in people with severe bleeding from the digestive system.~   "
145855|NCT01657968|"~     The primary purpose of the present study is to investigate the usefulness of Procalcitonin as~     a supplement to the Streptococcal antigen test and Centor criteria in the differential~     diagnose making between Streptococcal and non-Streptococcal acute tonsillitis.~      Furthermore, the investigators aim to examine Procalcitonin as a diagnostic marker in acute~     tonsillitis due to Fusobacterium Necrophorum.~   "
145856|NCT01657955|"~     The purpose of this study is to determine whether bendamustine is effective in the treatment~     of initial treatment of Chronic Lymphocytic Leukemia (CLL).~   "
145857|NCT01657942|"~     The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential~     to be an effective non-invasive treatment for intermediate risk, organ-confined prostate~     lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring~     treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated~     patients, as described above.~   "
145844|NCT01658111|"~     Numerous studies showed that ascertaining the effectiveness of rehabilitative interventions~     on conditions leading to long-term disability, such as stroke, is a complex task because the~     outcome depends on many interacting factors. Several studies underline the importance of~     brain plasticity and its therapeutic potential in neurological disorders. Accredited theories~     of cortical reorganization after brain lesion endorse the use of early, intensive,~     repetitive, and context-related exercise as optimal strategies to promote motor relearning~     and minimize motor deficit. The use of robotic systems in upper limb motor rehabilitation~     programs has been already demonstrated to provide safe and intensive treatment to subjects~     with motor impairments due to a neurological injury: several studies showed the advantages of~     robotic therapy on chronic post-stroke patients, even if no consistent influence on~     functional abilities was found and evidence of better results providing intensive treatments,~     both robotic and conventional rehabilitative techniques, was found. Recent development and~     recent trial in robot-assisted rehabilitation has shown the great potential of robotic~     devices for delivering repetitive training, thus facilitating a high intensity and a large~     dose of training during sub-acute and chronic phases of stroke rehabilitation. The proposed~     project, through a randomized controlled observer-blind multicenter trial is aimed at~     evaluating the effectiveness of robot-assisted therapy as additional treatment to the~     standard physical therapy in the early phase after stroke onset and evaluating in conjunction~     with EEG and EMG recordings the effects of the rehabilitative treatments in a quantitative,~     measurable way, by providing reliable and objective methods for measuring functional recovery~     after stroke.~   "
145845|NCT01658098|"~     This research will use the Edinburgh Scale Of Post partum depression to evaluate patients~     during their 4th to 6th after delivery, and the investigators will compare the results with~     those found in other countries with population with similar characteristics as ours~   "
145846|NCT01658085|"~     Study Design Multinodular Goiter (MNG) patients requiring surgery were referred to the~     Endocrine Surgery Unit.~      Indirect laryngoscopy was routinely performed preoperatively to assess normal motility in~     vocal folds (VF). Ultrasounds (US) study was performed the month previous to surgery to~     evaluate thyroid volume. Eligible patients met the following criteria: to have MNG, age~     between 18 and 80 and consent to be included in the study. Exclusion criteria included~     previous neck surgery, vocal fold impairment, permanent or transitory NSAID or analgesic~     treatment, coagulation disorders and any cognitive impairment.~      Eligible patients were proposed to enter a randomized study with 2 arms in which we compared~     the use of two harmonic scalpel devices: ACE14S and Harmonic Focus (Ethicon Endo-Surgery,~     Cincinnati, OH, USA).~      The main endpoint was operative time. Secondary endpoints were total and relative (%) time of~     use of the device along thyroidectomy, recurrent laryngeal nerve (RLN) injury and~     hypocalcaemia (both persistent or temporary), number of ligatures, length of skin incision,~     postoperative pain according to a visual scale of pain, QOL after thyroidectomy (EuroQOL) and~     budget impact analysis.~      All patients were operated on by 2 surgeons, one senior (responsible for the Endocrine~     Surgery Unit) and one junior under supervision.~      Randomization Randomization was performed the same day of surgery at the OR by using a closed~     envelope. Patients were randomized to Group I (ACE14S) or Group II (HF) and allocated in a~     1:1 proportion; they reminded blinded until the end of the study about the device used.~      The haemostasis device was communicated to the surgeon previous to start surgery. Medical~     staff of the Endocrine Surgery Unit collected clinical data.~      Surgical Technique Total thyroidectomy (TT), defined as total bilateral extracapsular~     lobectomy 9, was performed using HF or ACE14S for vessel division. Monopolar and bipolar~     forceps for cutting and coagulation were routinely used. Ties were used under surgeon's~     criteria according to size of the vessels and/or the need to obtain haemostasis in the~     vicinity of the RLN when bipolar forceps were not considered safe enough.~   "
145847|NCT01658072|"~     The best way to provide analgesia after total hip arthroplasty is hotly debated. There are~     two protocols in use at Hospital for Special Surgery(HSS). Both protocols have their~     proponents, but there are limited data for making an informed choice of protocols. For total~     hip arthroplasty at HSS, epidural analgesia is used most frequently as it reduces pain with~     physical therapy. However, epidural analgesia can be associated with nausea, pruritis,~     dizziness, and orthostatic hypotension. These side-effects can slow physical therapy and may~     prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided~     to use a different analgesic protocol, based on a peri-articular injection. This protocol~     avoids epidural analgesia and systemic opioids. However, patients are given oral opioids as~     part of a multimodal pain therapy. The investigators propose to compare peri-articular~     injection to epidural patient controlled analgesia (Epidural PCA). The investigators will~     enroll 90 total patients (45 per study arm). The enrollment period will be approximately one~     year and the duration of the follow-up with study patients will be three months following~     their procedure.~   "
145848|NCT01658059|"~     Pharmacological interventions to aid behavior management's techniques are commonly used in~     pediatric dentistry. The aim of the medicaments is to control behavior and allow safe~     completion of a dental procedure. Homeopathic remedy is safe and can be effective to control~     behavior and decrease anxiety in children during dental treatment.~      Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety~     before dental treatment.~      2. To assess the effectiveness of homeopathic remedy in facilitating dental treatment for~     anxious children.~      Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will~     receive homeopathic remedy\placebo before dental treatment. Anxiety reduction will be~     measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS),~     and Houpt behavior scale.~      Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation~     during dental treatment.~   "
145849|NCT01658046|"~     Skeletal muscle dysfunction impairs exercise capacity, quality of life and prognosis in~     chronic obstructive pulmonary disease (COPD). The purpose of this prospective randomized~     controlled study was to evaluate effects of Neuromuscular electrical stimulation (NMES) plus~     quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training~     (control group) on muscle function, exercise capacity, health related quality of life,~     activities of daily living, and self-efficacy in patients with COPD who are eligible and able~     to participate in endurance training.~   "
145850|NCT01658033|"~     The objective of this phase II study is to evaluate efficacy and safety of avastin plus~     modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five~     patients will be enrolled into this study.~   "
145851|NCT01658020|"~     The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple~     dose of Zabofloxacin Tablet 400 mg.~   "
145852|NCT01658007|"~     The investigators want to learn about treating relapsed/refractory lymphoblastic leukemia and~     lymphoma with a drug called sirolimus. The investigators are using sirolimus along with other~     cancer drugs that are often given to patients with relapsed leukemia and lymphoma.~      The main purpose of this study is to determine if sirolimus can be given safely in~     combination with standard drugs used to treat relapsed lymphoblastic leukemia/lymphoma.~   "
145858|NCT01657929|"~     The purpose of this study is to determine the safety, tolerability, and immunogenicity in~     healthy adult subjects of an investigational vaccine being developed for the prevention of~     pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant~     influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based~     expression system assembling into virus-like particles together with the adjuvant GLA-AF.~   "
145859|NCT01657916|"~     Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align~     Urethral Support System.~   "
145860|NCT01657903|"~     The purpose of this study is to compare and evaluate the ability of two European Union (EU)~     regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a~     modified in-situ model of dental erosion and remineralization. A positive control i.e~     fluoride containing toothpaste marketed in EU will also be compared to non-fluoride~     toothpaste.~   "
145861|NCT01657890|"~     The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy~     non-elderly and elderly male and female subjects.~   "
145862|NCT01657877|"~     In situ study to compare treatment effect on enamel remineralization potential, measured by~     surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will~     explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice~     containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only~     dentifrice.~   "
145863|NCT01657864|"~     The objective of the study is to quantify the number of cases of aseptic meningitis among~     users of Lamotrigine. This study is a cross-sectional study design using data on lamotrigine~     patients within the Thomson Reuters MarketScan® Commercial database (MarketScan database).~     The MarketScan database is a US-based insurance claims database representative of a US~     insured population and includes supplemental datao n Medicare patients. This cross-sectional~     study will evaluate the number of cases of aseptic meningitis among lamotrigine users during~     the duration of lamotrigine therapy, with an extended exposure window of 30 days after~     completing therapy.~      The MarketScan® Database is an US insurance claims database that is held in-house at GSK,~     which can be interrogated to examine rates of prescribing and medical conditions that can be~     captured via ICD-9 diagnoses codes. The MarketScan database captures person-specific clinical~     utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug,~     and carve-out services from a selection of large employers, health plans, and government and~     public organizations. The annual medical databases include private sector health data from~     approximately 100 payers. In 2011, there were approximately 35 million patients on the~     database. The Commercial Claims and Encounters Database represents the medical experience of~     insured employees and their dependents for active employees, early retirees, COBRA continues,~     and their dependents insured by employer-sponsored plans (i.e., non-Medicare eligibles). In~     addition, a linked Medstat Medicare database contains predominantly fee-for-service plan data~     in insurance plans where both the Medicare-paid amounts and the employer-paid amounts were~     available and evident on the claims.The data are HIPAA compliant thus all patients have been~     anonymized.~   "
145864|NCT01657851|"~     Open-label, randomized, single dose, two-treatment, two-way crossover study~   "
145865|NCT01657838|"~     The purpose of this study is to assess the effect of ketoconazole at steady state on the~     pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.~   "
145866|NCT01657825|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of warfarin after single dose administration.~   "
145867|NCT01657812|"~     Clinically, combining epidural with general anaesthesia may confer many advantages to~     patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia~     can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis,~     spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However,~     establishing epidural anesthesia is not without risks and contraindications, including~     refusal by the patient, technical failure, unintentional dural puncture, waist and back pain~     and local anaesthetic toxicity. When neurologic complications do occur, the resulting~     morbidity and mortality is considerable. Dexmedetomidine is a potent α2-adrenoceptor agonist~     with an 8 times greater affinity for α2-adrenoceptors than clonidine. This class of agent is~     known to have sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing~     effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and attenuate~     the stress response associated with surgery.1 Unlike epidural anaesthesia, dexmedetomidine is~     easy to administer and no potential for neurological damage. The investigators hypothesize~     that the dexmedetomidine reduces the stress response of surgery to the similar extent to~     epidural anaesthesia when used in conjunction with a standard general anaesthesia for~     abdominal surgery.~   "
145868|NCT01657799|"~     The primary objective of this study is to evaluate the efficacy and safety of veliparib and~     whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer~     (NSCLC).~   "
145869|NCT01657786|"~     Postoperative nausea and vomiting (PONV) is a common and distressing complication in patients~     undergoing general anesthesia. However, although 5-hydroxytryptamine type 3 (5-HT3) receptor~     antagonists have significantly reduced PONV, it is reported that over 35% of patients treated~     with ondansetron experience PONV. Though the cause of failure in ondansetron treatment is not~     clear, the investigators assumed that polymorphism in the 5-HT3 receptor gene would~     contribute to such inter-individual variation. In this study, the investigators examine~     whether the polymorphisms of 5-HT3 receptor gene affect the efficacy of ondansetron to~     prevent PONV in patients undergoing general anesthesia for laparoscopic surgery.~   "
145870|NCT01657773|"~     The aim of this sudy is to investigate the prevalence of colorectal cancer (CRC) in patients~     with nonalcoholic fatty liver disease (NAFLD) and evaluate whether NAFLD is a risk factor for~     CRC.~   "
145871|NCT01657760|"~     Alcohol use disorders (AUDs) are highly prevalent among U.S. civilians, and even more~     prevalent in the U.S. Veteran population. AUDs are frequently co-morbid with depressive~     symptoms in psychiatric clinical populations, resulting in an increased severity of both~     conditions. Indeed, returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)~     Veterans have extraordinarily high rates of alcohol misuse and co-morbid psychiatric~     symptoms, indicating that future Veteran clinical populations will be particularly affected~     by AUDs. While FDA-approved medications are available to treat AUDs, their efficacy is low~     compared to available psychosocial treatments. Despite the lack of evidence for efficacy from~     controlled trials, antidepressants are frequently prescribed to clinical populations~     (including Veterans) with active AUDs. A better understanding of patient-level clinical~     variables that may confer poor response to treatment with antidepressants would allow~     clinicians better tools to distinguish those alcohol-dependent Veterans likely to do worse~     with antidepressant treatment.~   "
145950|NCT01656733|"~     This is a clinical trial to determine if the nicotine inhaler in combination with counseling~     will help pregnant women quit smoking, and whether it is safe when compared to placebo (an~     inactive inhaler).~   "
145873|NCT01657734|"~     Malignant gliomas are aggressive tumours with poor prognosis despite the current multimodal~     treatment. Hence, there is a clear need for new, effective therapies, among which immune~     therapy has emerged as a promising treatment option.~      When interpreting follow-up magnetic resonance (MR) examinations, the radiologist is often~     confronted with images that are difficult to interpret with the conventional anatomical~     imaging techniques. The difference between tumour relapse and therapy-mediated changes is not~     always distinctive.~      In this project, the investigators attempt to characterize the inflammatory response with~     parameters from advanced MRI techniques like MR spectroscopy, MR perfusion imaging and~     MR-diffusion imaging. These techniques allow characterization of cellular properties like~     metabolism and tissue structure respectively. Doing so, the investigators will monitor~     disease evolution in order to timely detect treatment failure, thereby allowing appropriate~     switch in patient management.~   "
145874|NCT01657721|"~     The overall objective of the current study is to determine whether computerized Working~     Memory (WM) training will enhance WM capacity in college students with Attention Deficit~     Hyperactivity Disorder (ADHD). There are also four additional objectives. The first is to~     investigate whether the program's efficacy is impacted by the duration of the daily training~     sessions. The second is to determine whether improvements in WM will generalize to secondary~     outcome tasks, such as inhibitory control and planning. The third objective is to examine~     whether WM training will also ameliorate ADHD symptoms of inattention and hyperactivity. The~     last objective is to investigate whether improvements will be maintained at a two month~     follow-up period. The investigators will also be assessing healthy control participants,who~     will not be receiving treatment, but will be used as a basis of comparison with the ADHD~     participants,~      It is expected that the computerized WM training program will enhance WM capacity in college~     students with ADHD. In addition, it is believed that these increases in WM capacity will also~     lead to improvements in other executive functions. It is also hypothesized that WM training~     will lead to a reduction in ADHD symptomology. Lastly, these improvements should be~     maintained at three month follow-up.~   "
145875|NCT01657708|"~     Background:~      Shared Decision Making (SDM) refers to a process of health care delivery in which~     practitioners and clients seeking help with decisions, collaborate to access relevant~     information and enable client-centered selections of health care resources (1, 2). SDM leads~     to better treatment adherence and outcomes for people with a medical problem (3). SDM~     principles have previously been used in psychiatry to improve antipsychotic and~     antidepressant medication adherence (4, 5); however, these principles have yet to be applied~     to psychiatric rehabilitation (6).~      The current research uniquely aims to test the development and implementation of a SDM~     intervention for people with psychotic spectrum disorders (e.g., schizophrenia and affective~     disorder) during the referral process to psychiatric rehabilitation services. The study will~     be conducted this year using a randomly selected sample from the population of people with~     psychotic spectrum disorders hospitalized in SHALVATA psychiatric hospital in Israel. It aims~     to facilitate better treatment and rehabilitation outcomes. It has received the support and~     approval of the Mental Health Division of the Ministry of Health (MOH) in Israel, the~     institutional review board (IRB) by the university of Haifa, Israel and a Helsinki committee~     approval by SHALVATA psychiatric hospital and the MOH in Israel.~      References~        1. Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: What does~          it mean?(or it takes at least two to tango). Soc Sci Med. 1997;44(5):681-92.~        2. Adams JR, Drake RE. Shared decision-making and evidence-based practice. Community Ment~          Health J. 2006;42(1):87-105.~        3. Joosten EAG, DeFuentes-Merillas L, De Weert GH, Sensky T, Van Der Staak, C. P. F., De~          Jong, C. A. J. Systematic review of the effects of shared decision-making on patient~          satisfaction, treatment adherence and health status. Psychother Psychosom.~          2008;77(4):219-26.~        4. Hamann J, Cohen R, Leucht S, Busch R, Kissling W. Do patients with schizophrenia wish to~          be involved in decisions about their medical treatment? Am J Psychiatry.~          2005;162(12):2382.~        5. Hamann J, Langer B, Winkler V, Busch R, Cohen R, Leucht S, et al. Shared decision making~          for in-patients with schizophrenia. Acta Psychiatr Scand. 2006;114(4):265-73.~        6. Drake RE, Deegan PE, Rapp C. The promise of shared decision making in mental health.~          Psychiatr Rehabil J. 2010;34(1):7-13.~   "
145876|NCT01657695|"~     Our long-term objective is to develop a new tool based on a (molecular-biology) integrated~     imaging technology able to characterize and categorize hepatocellular carcinoma (HCC)~     patients in need of liver transplant (LT). To this end, our study aims at correlating~     specific imaging traits and fractional growth of individual tumors collected over a~     restricted time frame (T0 and at week 7 after first tumor detection), with a molecular~     signature, obtained by custom microarray, histochemical and cytokine analysis. This should~     allow us to translate a series of purely morphologic information into a meaningful~     pathobiologic data sets. Validation of the integrated molecular-imaging tool will be~     performed prospectively by correlating the imaging-molecular data with HCC outcome in term of~     survival and disease-free survival after down staging procedures.~   "
145877|NCT01657682|"~     This pilot Phase II study is designed to evaluate the efficacy and tolerability of crenolanib~     in two cohorts of AML patients with FLT3 activation mutations (patients whose leukemia has~     recurred after prior chemotherapy not including a FLT3 TKI and patients whose leukemia has~     progressed after prior therapy with a FLT3 TKI).~   "
145878|NCT01657669|"~     This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection~     administered in subject who have active choroidal neovascularization due to Age Related~     Macular Degeneration (AMD).~   "
145879|NCT01657656|"~     Hypothesis~      That improving vitamin D status among TB patients will speed the pace of bacteriological~     cure, and will enhance immune responses to TB infection~   "
145880|NCT01657643|"~     The main purpose of the study is to find out if probiotics (healthy bacteria found in yogurt)~     can improve the health-related quality of life (HRQL) during upper respiratory infections~     (like the common cold) in college students living in residence hall on-campus at Framingham~     State University (Framingham, MA) who are randomized to receive a probiotic or placebo candy~     daily for 12 weeks. HRQL is a subjective measure, defined as the aspects of quality of life~     (i.e., one's satisfaction with their life) that related specifically to a person's health~     (for example, ability to carry out normal daily activities). The investigators hypothesize~     that HRQL during URIs will be significantly higher in the probiotic groups compared to the~     placebo group. The proposed study will also seek to address the following secondary~     objectives: missed school and work days due to a upper respiratory infection.~   "
145881|NCT01657630|"~     This is an open, prospective, descriptive study aiming to evaluate the change in treatment~     satisfaction of primary care givers of young children who use the Accu-Chek Combo System.~     Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System~     on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment~     Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a~     distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes~     related therapeutic information will be collected and data about the use of the device~     components will be downloaded from the Accu-Chek Combo System~   "
145882|NCT01657617|"~     It is apparent that local control for Non-small Cell Lung Cancer (NSCLC) remains a~     significant problem. Conventional radiation therapy techniques have limitations for the dose~     that can be delivered to a chest tumor mass due to the adjacent dose limiting organs.~     Mounting evidence supports the use of hypofractionated stereotactically delivered radiation~     therapy to control lung cancer with acceptable toxicity profiles.~      Thus the investigators propose to increase the doses of radiation to residual masses of NSCL~     to a BED > 100 Gy by the addition of two fractions of stereotactically delivered boost~     radiation therapy to residual disease post-conventional chemoradiation to at least 59.4 Gy in~     180 cGy fractions. Using the linear quadratic equation to model doses of radiation therapy,~     59.4 Gy would have a BED of approximately 70 Gy. Single fraction stereotactic body radiation~     therapy (SBRT) of 10 Gy would have a BED of approximately 20 Gy. Thus the addition of two~     fractions of 10Gy of SBRT to limited volumes of PET residual disease would theoretically~     result in higher degrees of local control of lung cancer masses, achieving a minimum~     cumulative BED of approximately 110Gy-equivalent.~   "
145883|NCT01657604|"~     Advances in Chronic Myeloid Leukemia (CML) therapy led to an expected survival prolongation~     of > 20 years after diagnosis. So far, discontinuation of tyrosine kinase inhibitors led to~     recurrence of disease in the majority of patients. The trial aims to improve treatment~     strategies in CML by improving induction therapy and deescalating maintenance therapy using~     low dose IFN as inducer of immunosurveillance. The trial will provide important data on the~     duration of active therapy in CML patients. Considering the rapidly increasing prevalence of~     CML this is of individual but also socioeconomic importance.~   "
145884|NCT01657591|"~     This is a multi-cohort, dose-escalation study of XL888 with a fixed dose of vemurafenib. New~     dose escalation or de-escalation cohorts will be assigned by the Principal Investigator (PI)~     with discussion with appropriate co-investigators once safety and tolerability is known for a~     given cohort in accordance to dose escalation rules. Participants will be defined to be~     enrolled within a cohort upon receipt of first dose of XL888/vemurafenib.~   "
145885|NCT01657578|"~     The principal aim of this trial is to determine the minimum effective dose of omeprazole in~     neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry),~     to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24 after~     initiation of omeprazole.~      The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon~     other pHmetry parameters, (2) to characterize the population pharmacokinetics and~     pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal~     pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates.~   "
145886|NCT01657565|"~     Introduction: An increasing proportion of childhood appendicitis is treated with laparoscopic~     appendectomy (LA). The investigators wanted to elucidate the outcome of childhood~     appendicitis treated primarily by residents in a university hospital.~      Material and methods: All children (age<16 years) treated surgically with appendectomy in our~     department between January 2006 and January 2011 were retrospectively identified.~     Readmission, reoperation or postoperative length of stay (LOS) exceeding five days were~     considered as non-satisfactory outcomes.~   "
145887|NCT01657552|"~     The purpose of the current Phase I, open-label, three-period, single sequence, crossover~     study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag~     (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this~     study there will be a screening visit, three treatment periods, and a follow-up visit. In~     Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK)~     sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with~     PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP~     on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit~     within 10 to 14 days of the last dose of study drugs. The total duration of the study from~     Screening to Follow-up will be approximately 9 weeks.~   "
145888|NCT01657539|"~     Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp.~     lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms~     of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment.~     Methods: A crossover, double-blind, randomized and placebo controlled clinical trial will be~     performed with 26 volunteers during 4 periods. During periods 2 and 4 (2 weeks each) the~     volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt~     which did not contain probiotic. Periods 1 and 3 were run-in and wash-out periods of 1 and 4~     weeks, respectively. Experimental samples of saliva and biofilm will be collected from each~     participant at the end of each phase. Mutans streptococci, lactobacilli, total aciduric~     microorganisms, Candida spp. and total cultivable microorganisms will be counted. The values~     before and after the treatment will be compared with Wilcoxon's test (p<0.05).~   "
145889|NCT01657526|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK~     Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.~   "
145890|NCT01657513|"~     TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are~     well-tolerated with few side effects.~      Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some~     do not respond at all while others respond initially but gradually lose effect despite~     increased dose and more frequent administration.~      The cause of treatment failure is largely unknown and it may be production of tnf-alfa~     neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis and~     inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.~   "
145891|NCT01657500|"~     The purpose of this study is to compare the success of storing a donor cornea in Optisol GS,~     the current standard vs. storing the donor cornea in Life4°C, a newer solution. The donor~     cornea to be used for EK will be provided by an eye bank and will have been stored in either~     an Optisol GS solution or a Life 4°C solution. At 6 months, the doctors will determine~     whether there are any comparable differences in cell loss and graft clarity between the two~     donor corneas.~   "
145892|NCT01657487|"~     This study is to investigate and compare treatment efficacy with high and medium dose of~     fluticasone in combination with salmeterol in COPD patients.~   "
145893|NCT01657474|"~     The purpose of this study is to determine whether a weekly application of EpiFix human~     amniotic membrane is more effective than a biweekly application (every two weeks) in the~     treatment of diabetic foot ulcers.~   "
145894|NCT01657461|"~     The primary study objective is to determine if subjects experiencing an acute ischemic stroke~     due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization~     Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS)~     than those subjects treated with IV t-PA alone~   "
145895|NCT01657448|"~     The purpose of this study is to evaluate the efficacy of the combination of Methenamine +~     Methylthioninium chloride compared to phenazopyridine (comparator product) in the symptomatic~     relief of dysuria.~   "
145896|NCT01657435|"~     This study is intended to gather medium (0-5 years) and long-term (6-10 years) information~     regarding the performance and safety of the commercially available Ceramax™ Ceramic on~     Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase~     and a clinical outcomes phase.~      In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered~     for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective~     evaluations and radiographs will be completed annually.~      In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey~     will be mailed to subjects annually.~   "
145897|NCT01657422|"~     PACE+ was developed to address the increased number of adolescents in our country that are at~     risk for cardiovascular disease, cancer, and other diseases due to inactivity, obesity, and~     malnourishment. PACE+ will evaluate the efficacy of an integrated clinical and home-based~     intervention to improve physical activity and nutrition behaviors in adolescents ages 11-15~     over a period of 2 years.~      This study is unique in that it will be one of the first to evaluate a combined physical~     activity and nutrition intervention for youth that revolves around the primary health care~     setting. The PACE+ intervention is particularly innovative in that three components -~     computer, provider counseling, and an extended home-based intervention - are unified through~     a common theoretical framework.~   "
145898|NCT01657409|"~     Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or~     without urge urinary incontinence (UUI) that may affect the patients' quality of life.~     Current medical treatments are usually unsuccessful in completely eradicating urgency~     sensation. Intra-detrusor injection of botulinum toxin A (BoNT-A) modulates the release of~     neurotransmitters from sensory nerve endings and effectively modulates the inflammatory~     process mediated by nociceptive afferent nerve dysfunction. Satisfactory clinical results~     were achieved with intravesical BoNT-A injection, which increased bladder capacity and~     decreased urgency sensation in patients with neurogenic or idiopathic detrusor overactivity~     (NDO, IDO). Excellent results were achieved with injection of either 100 U or 200 U of~     BoNT-A. Episodes of frequency, urgency, and UUI were reduced, maximal cystometric capacity~     increased, maximal detrusor pressure (Pdet) decreased, and the quality of life index also~     improved significantly. However, post void residual (PVR) volume increased significantly and~     some patients required clean intermittent catheterization (CIC) to evacuate the PVR.~     Dose-related adverse events (AE) increased with increasing dose of BoNT-A. Therefore,~     adjustments of the BoNT-A dose and sites of injection might minimize the de novo AE and help~     to maintain success rates.~   "
145899|NCT01657396|"~     The primary objective of this study is to evaluate the effectiveness and feasibility of the~     implementation of revised standards of care for oral hygiene (SAGE Q-care q2 Oral Cleansing~     and Suctioning System with and without chlorhexidine gluconate) relative to the current~     routine standard of care in mechanically ventilated patients admitted to the adult Intensive~     Care Units in Alberta Health Services Calgary Zone. This pilot study will evaluate the~     feasibility of performing a larger definitive study. The primary assessment of effectiveness~     for the definitive study will be the proportion of patients who develop ventilator-associated~     pneumonia.~   "
145900|NCT01657383|"~     The collection of data regarding patient outcomes after surgical intervention creates~     imperative knowledge to include surgeon performance, cost analysis, base for surgical~     research and publication, which in turn assist surgeons to improve the standard of care~     utilizing evidence-based practice.~   "
145901|NCT01657370|"~     The purpose of this study is to characterize the pharmacokinetics of MK-1602 in the treatment~     of acute migraine, including the influence of demographic and other variables on MK-1602~     pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations and~     efficacy of the drug.~   "
145902|NCT01657357|"~     Follow up study of patients, who despite periacetabular osteotomy, need a total hip~     arthroplasty, to see outcome.~   "
145903|NCT01657344|"~     The objectives of this study are to: develop an emergency care visit registry for pediatric~     patients for Quality Improvement purposes and to support future research; to use the~     emergency care visit registry to collect stakeholder-prioritized emergency care performance~     improvement measures for important pediatric medical and trauma conditions at the level of~     the Emergency Department (ED) and individual clinical; and report emergency care performance~     improvement measures to individual ED clinicians and sites, and measure subsequent changes in~     quality performance. The hypothesis is that by providing this type of information to~     individual clinicians will result in improved performance and decreased variability~     (variation) of care for an individual clinician, between different clinicians, and eventually~     between hospital sites.~   "
145904|NCT01657331|"~     This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab~     vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or~     Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial~     treatment(s). Patients will be accrued at Columbia University Medical Center (CUMC) and at~     two subsites in Canada.~   "
145905|NCT01657318|"~     In this study, the investigators hypothesize that the use of olivamine-containing products in~     the management of patients with compromised nonhealing lower extremity ulcers is feasible in~     the Philippine setting. It will result in complete ulcer healing or wound closure after 16~     weeks.~   "
145906|NCT01657305|"~     The main purpose of this phase III clinical trial was to compare intra-individually the~     efficacy, safety and tolerability of Oleogel-S10 and non-adhesive wound dressing versus~     non-adhesive wound dressing only in accelerating the wound healing of Split-Thickness Skin~     Graft (STSG) donor sites.~   "
145907|NCT01657292|"~     The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10~     in the acceleration of wound healing of grade 2a burn wounds.~   "
145951|NCT01656720|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of NRL001 in~     the treatment of faecal incontinence, compared against placebo~   "
145908|NCT01657279|"~     Background: Several risk score models are now available to assist clinicians estimate~     outcomes after an acute ischemic stroke. Limited information is available on the predictive~     value of these scores compared to real outcomes and clinical judgment.~      Objectives: To compare clinician judgment with the use of a validated stroke risk score~     (iScore) and patients' outcomes.~   "
145909|NCT01657266|"~     The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution~     PRO-155 in patients post phacoemulsification.~   "
145910|NCT01657253|"~     The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution~     PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with~     ophthalmic solution Systane®~   "
145911|NCT01657240|"~     The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution~     PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic~     conjunctivitis.~   "
145912|NCT01657227|"~     Objective:~        -  To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by~          influencing disease self-management through lifestyle modification and by helping~          primary care professionals to improve health care provided to patients.~        -  To assess the effectiveness and cost-effectiveness of two complex interventions~          (education and behavioural modification, independently and conjointly, for primary~          health care teams (PHCT) and patients and their relatives) to improve the health results~          in people with T2DM.~      Methodology:~      Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands.~     Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures:~     HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm.~     Intervention: G1: Interventions on the patients: Educational and habit modification group~     program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge~     about the disease and their abilities; b) Computer-based clinical decision support system; c)~     Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group.~     Patients receive only the usual care.~   "
145913|NCT01657214|"~     Primary Objective:~      In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844.~      In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in~     patients with measurable and MET gene amplification (including gastric cancer patients).~      Secondary Objectives:~      To characterize and confirm the global safety profile of SAR125844 including cumulative~     toxicities.~      To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects~     (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the~     relationship of MET gene amplification status with antitumor effects.~      To evaluate other pharmacodynamic biomarkers.~   "
145914|NCT01657201|"~     The purpose of this study is to evaluate the pharmacokinetic properties and safety of~     SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).~   "
145915|NCT01657188|"~     Prospective, follow-up registry of heart failure patients with or without sleep-disordered~     breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with~     Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac~     performance and event-free survival.~   "
145916|NCT01657175|"~     This study aim to assess quality of life of patients 0-5 years after oesophageal or gastric~     cancer surgery and to develop and test an information and support program aiming to enhance~     the patients quality of life (QOL) after surgery. The project contains 3 part-studies~     focusing on the patients life after surgery.~      Data will be collected through focus group interviews and a randomized controlled trial (RCT)~     study.~   "
145917|NCT01657162|"~     The purpose of this study is to provide 24 months of standard of care data on subjects~     previously enrolled in study BA058-05-003.~   "
145918|NCT01657149|"~     To investigate the effects of lymphatic drainage massage performed immediately after total~     knee replacement in relation to reduction of limb circumference, pain reduction and~     functional improvement.~   "
145919|NCT01657136|"~     The aim of this study is to prospectively compare the effectiveness and safety of ivabradine~     and beta-blockers in the treatment of inappropriate sinus tachycardia.~   "
145920|NCT01657123|"~     Exposure to stress alters the activity of the adrenomedullary, adrenocortical and sympathetic~     nervous system, depending on the type and intensity of the stressor. Physical exercise~     represents a stress condition influencing many systems in the body. Given a workload of at~     least 70-85% of Vo2max, exercise is a potent stimulus of the hypothalamic-pituitary-adrenal~     (HPA)-axis. The increased endogenous cortisol secretion results in important metabolic and~     cardiovascular effects to maintain cellular and organ homeostasis. Patients with Addison's~     disease are not able to meet the increased demand of adrenal steroids in case of physical~     exercise, which may result in an impaired exercise capacity and a prolonged post-exercise~     recovery. We hypothesize that a hydrocortisone stress dose increases exercise capacity and~     improves post-exercise recovery in patients with Addison's disease.~   "
145921|NCT01657110|"~     Mild to moderate facial acne is an extremely common disease of teenagers and young adults.~     This pilot study will investigate whether treatment with a gel containing tea tree oil~     reduces numbers of acne lesions and improves acne in twenty otherwise healthy consenting~     participants. The hypothesis is that treatment with tea tree oil gel will result in a~     significant improvement in acne after 12 weeks of treatment.~   "
145922|NCT01657097|"~     Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was~     performed to gain information on this inflammation, including effect of intranasal~     corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.~      The study was randomised, placebo-controlled double-blind in patients, monoallergic to~     grasspollen, presenting symptoms of rhinitis and asthma during season.~      Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of~     treatment intranasal allergen challenge was performed. Measurements were performed during the~     full study period.~      The study was performed out of pollen season.~   "
145923|NCT01657084|"~     By enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is induced,~     without causing hypoxia in the patient.~      Based on the scientific literature on the subject, the study hypothesis is that the fall in~     body pH will be able to stop and/or prevent epileptic brain activity.~   "
145925|NCT01657058|"~     Soluble, viscous fibre has been established as an effective dietary component for lowering~     postprandial glycemia and promoting satiety. The effectiveness of viscous fibre has been~     related to its ability to increase the viscosity of the intra-luminal contents of the small~     intestine. Hence, the proposed mechanism with which soluble fibre affects the glycemic~     response, dependent on the viscosity development in the gut, would require that soluble fibre~     be extractable from the food matrix. This, in part, may be dependent on the food matrix that~     the soluble fibre is incorporated in. While properties of soluble fibre and their~     physiological effects have been studied extensively, limited data exists on the most~     effective mode of administration of fibre to optimize benefits. Furthermore, there are no~     studies to date that have evaluated how different modes of highly viscous soluble fibre would~     affect the subsequent meal. Hence, we propose a research study to determine whether the form~     of administration, taking into consideration the carbohydrate availability of a viscous fibre~     blend supplement, has a significant impact on postprandial and second meal glycemic response~     and subjective satiety in healthy individuals.~   "
145926|NCT01657045|"~     This study will investigate the safety and efficacy of using JVS-100 to accelerate wound~     healing and reduce scar formation in subjects receiving surgical incisions (sternotomies)~     during cardiovascular surgery. Twenty-five (25) subjects receiving a median sternotomy of 16~     - 25 cm in the process of cardiothoracic surgery will be enrolled consecutively and be~     followed for 6 months post-dosing. Three cohorts of approximately 8 subjects each will be~     enrolled, and within each cohort subjects will be randomized 3:1 to receive a single set of~     needle-free dermal injections of either JVS-100 or placebo. JVS-100 or placebo will be~     delivered along the edge of the sternal wound using a needle-free injection device that has~     FDA-clearance for subcutaneous injections.~   "
145927|NCT01657032|"~     Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized,~     double blind, placebo-control trial was performed to assess the effectiveness of both LGG and~     smectite in management of children with acute gastroenteritis (AGE).~   "
145928|NCT01657019|"~     To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or~     70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults~   "
145929|NCT01657006|"~     The investigators intend to prospectively enroll consecutive patients, without known ischemic~     heart disease, referred by their physician for routine exercise MPI at a tertiary care~     center.~      Prior to the MPI (nuclear stress test), eligible and consenting patients will undergo a~     one-hour period of Holter ECG digital recording. Application of ECG electrodes will be~     performed by medical technicians following standard recommendations, utilizing approved~     Holter device & stickers. The Holter ECG data will be used for the offline heart rate~     variability (HRV) analysis by the HeartTrends device.~      Immediately following data acquisition, all patients will undergo an exercise MPI according~     to accepted clinical practice guidelines.~      Following the MPI, there will be no interference with patient management, which will be~     conducted by the patients' treating physicians according to current guidelines, unaware of~     HRV results.~      Analysis of recorded ECG data for HRV will be performed blinded to the EST and MPI results,~     by HeartTrends device.~      The results of the HRV tests will not be available to treating physicians and will not be~     used to guide patient management. Patients will be followed for 6 months for the occurrence~     of coronary interventions and MACE, defined as: death, myocardial infarction, unstable~     angina, or any coronary revascularization.~   "
145930|NCT01656993|"~     Background: Blood clots cause poor outcomes, including death, in babies with heart defects~     that require a surgical connection (shunt) to provide blood flow to their lungs. Aspirin~     (ASA) blocks the part of the blood that helps clots form (platelets). Aspirin is used in~     babies with shunts to prevent blood clots. The dose of aspirin given to babies is based on~     adult research. Because babies are different from adults, the investigators do not know if~     the dose is enough to block platelets, or if it is too much and may cause bleeding. The~     investigators can test the platelets using a blood test called Thromboelastography with~     Platelet Mapping (TEG-PM). This test needs a small amount of blood so it can be used in~     babies.~      Hypothesis and Specific Aims: The investigators suspect the aspirin doses typically given~     babies are not enough to block platelets and prevent blood clots in their shunts. The~     investigators want to determine the percentage of babies whose platelets are not blocked~     enough (< 70% inhibition), by using TEG-PM. The investigators also want to determine how~     often bleeding or clots occur in babies receiving aspirin.~   "
145931|NCT01656980|"~     The purpose of the study is to determine the safety and efficacy of intracranially implanted~     Carmustine in the treatment of patients with primary malignant glioma.~   "
145932|NCT01656967|"~     The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu®~     Aura-I and the Intubating Laryngeal Mask Airway (ILMA), regarding time to intubate, ease of~     insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu~     Aura-I, ease and success rate of intubation, airway morbidity, and patient comfort in~     patients undergoing general anesthesia for elective surgery.~   "
145933|NCT01656954|"~     The purpose of this study is to understand and document measurements in heart stroke volume~     (the volume or amount of blood pumped per heart beat) and cardiac output (the volume or~     amount of blood pumped by your heart per minute) during a passive leg raise maneuver~     (elevation of the legs), and to determine if these measurements can predict changes in the~     same as a result of fluid or blood product administration.~   "
145934|NCT01656941|"~     The purpose of this study is to examine the role of genetic variation in the oxidative stress~     response on critical perioperative and short-term outcomes after neonatal heart surgery. The~     goals will be to determine 1) if the oxidative stress pathway is an important one for~     therapeutic intervention in neonates with severe congenital heart defects and 2) if variants~     in the oxidative response pathway can be used to identify patients at increased risk for~     adverse outcomes.~   "
145935|NCT01656928|"~     This study assesses the impact of a nutritional intervention aimed at reducing childhood~     overweight in German preschoolers.~   "
145952|NCT01656707|"~     The purpose of this study is to examine an Adaptive Treatment approach in order to improve~     outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.~   "
145936|NCT01656915|"~     Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an~     inflammatory response and examine differences in the inflammatory response between healthy~     and compromised subjects.~      The purpose of the current study is to examine the inflammatory response in a younger~     population (35-45 yrs old) to see whether in this population also differences in the ex vivo~     LPS induced cytokine response exists between healthy and compromised subjects, as is seen in~     elderly subjects. Overweight subjects showing a state of disturbed blood glucose control will~     be included as subjects with compromised health and compared to healthy lean subjects with~     the same age (shifting from healthy towards unhealthy, not diseased).~      Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory~     cytokine response in a healthy population that is different from a response of the~     compromised population. The investigators will include subjects aged 35-45 years that differ~     in health characteristics, especially blood HbA1c, fat% and waist circumference.~   "
145937|NCT01656902|"~     In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation~     technique) is compared to standard of care therapy (microfracture) to treat traumatic~     cartilage defects of the knee for efficacy and safety. The investigated study treatment~     NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes~     derived from the patient in a previous tissue harvest procedure. Allocation to the study~     treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational~     product). Follow-up data for efficacy is collected for 2 years: follow-up visits are~     performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment;~     additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after~     treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for~     implantation surgery), and blood withdrawal for safety within the first year after treatment.~     Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is~     done as substudy at specific sites only.~   "
145938|NCT01656889|"~     This study is being done to find out if an investigational product called HP802-247 can help~     people with venous leg ulcers. Investigational means that HP802-247 has not been approved by~     the U.S. Food and Drug Administration (FDA).~      This research is being done to compare the efficacy of HP802-247 plus compression therapy~     against Vehicle plus compression therapy in achieving complete wound closure over the 12-week~     treatment period. Vehicle looks the same as HP802-247 but contains no cells.~   "
145939|NCT01656876|"~     The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror~     therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people~     with stroke.~   "
145940|NCT01656863|"~     The purpose of this study is to determine parental attitudes towards oral rehydration therapy~     for children with mild to moderate dehydration.~   "
145941|NCT01656850|"~     The purpose of the study is to examine whether almond consumption for 3 month will help~     Chinese patients with type 2 diabetes control blood glucose and decrease risk factors of~     cardiovascular disease.~   "
145942|NCT01656837|"~     Parental substance abuse is a leading determinant of child maltreatment and, consequently, is~     often linked with negative clinical outcomes for children, exorbitant financial costs for the~     child welfare system, and serious social costs for the investigators nation. Yet, in spite of~     the seriousness of child maltreatment in the context of parental substance abuse and that~     there are well-established effective treatments for adult substance abuse, substance-abusing~     parents in the child welfare system are less likely to be offered services and receive~     services. Well-integrated treatments for the dual problem of substance abuse and child~     maltreatment are virtually nonexistent in the research literature. This study is a randomized~     controlled trial comparing Comprehensive Community Treatment to Multisystemic~     Therapy-Building Stronger Families (MST-BSF), an integrated model of two evidence-based~     treatments for parental substance abuse and child maltreatment that has shown promise in a~     4-year pilot.~      Statement of Study Hypothesis:~      Compared to Comprehensive Community Treatment, parents receiving MST-BSF will show greater~     reductions in parental substance abuse and psychological distress, greater increases in~     employment, drug-free activities, social support, and positive parenting, and fewer incidents~     of reabuse of a child. Children whose families receive MST-BSF will experience fewer child~     out-of-home placements and greater reductions in internalizing symptoms such as anxiety.~   "
145943|NCT01656824|"~     Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil~     reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice~     and transform their bone marrow cells into non-Bv8 producing cells. than we will implant~     primary human tumor tissue (taken from surgical specimens after informed consent)in those~     mice and follow-up on the mice.~   "
145944|NCT01656811|"~     Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II,~     parallel-group study of up to four weeks in duration. The study consisted of a screening~     visit followed by a one-week single blind placebo period. At next visit, each subject was~     randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180~     mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4~     times a day for 21 days.~   "
145945|NCT01656798|"~     The main objective of this study is to estimate the effect of food on sildenafil~     pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of~     sildenafil citrate.~   "
145946|NCT01656785|"~     This is an open-label brain PET/CT (positron emission tomography/computed tomography) study~     to investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in evaluation of stroke~     patients in convalescence. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg~     BNOTA-PRGD2) will be intravenously injected into the patients. Visual and semi-quantitative~     method will be used to assess the PET/CT images. Changes of 18F-FDG PET/CT, enhanced brain~     MRI or CT, and any adverse events will be collected from the patients.~   "
145947|NCT01656772|"~     This study will evaluate the use of a robotic device that is remotely controlled to maneuver~     a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation~     procedures.~   "
145948|NCT01656759|"~     Applying a fibrin spray, after knee device implantation, will help in reducing patient blood~     loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased~     blood loss there should be a reduced need for blood transfusions.~   "
145953|NCT01656694|"~     This study will be conducted to assess the survivorship of a particular prosthesis used in~     unicompartmental knee arthroplasties. Patients undergoing this procedure have been diagnosed~     with isolated medial or lateral compartmental arthritis and have failed conservative~     treatment. The patients received a unicompartmental knee replacement using the Sigma® HP~     Partial Knee System.~   "
145954|NCT01656681|"~     The purpose of this 2-stage intervention study is to investigate the effect of a novel~     nutraceutical (containing tetrahydro iso-alpha acids derived from hops) on weight loss and~     weight loss maintenance in obese participants.~   "
145955|NCT01656668|"~     The purpose of this study is to investigate the effect of BC1036 (theobromine) on~     cough-related quality of life and cough severity following 2 weeks' treatment.~   "
145956|NCT01656655|"~     PTSD affects a wide variety of symptoms, some of which have been shown to disrupt family~     relationships. This study will examine some of the effects on parenting, from the perspective~     of the parent with PTSD.~   "
145957|NCT01656642|"~     This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of~     atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with~     vemurafenib or vemurafenib plus cobimetinib in participants with BRAFV600-mutation positive~     metastatic melanoma. Enrolled participants may continue treatment until they are no longer~     experiencing clinical benefit as assessed by the investigator and in alignment with the~     protocol.~   "
145958|NCT01656629|"~     Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility~     fractures are devastating consequences of osteoporosis. The most common treatment approach in~     osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Parathyroid~     hormone (PTH) stimulates bone formation and is the only anabolic drug available. Dual therapy~     with ALN and PTH is not as effective as single-drug therapy in preventing fracture. Bone~     progenitor cells (MSCs) are recruited to sites of bone remodeling when a growth factor called~     Transforming Growth Factor Beta (TGF-β1) is released from bone. Different osteoporosis~     medicines may have differing effects on this process. The effects of ALN versus PTH on bone~     progenitor recruitment in humans are unknown. This is a randomized, clinical trial of ALN,~     PTH, and calcium and vitamin D in post-menopausal women with low bone mass. Women will be~     treated for 3 months with ALN or PTH or calcium and vitamin D. Data collected will include~     bone biopsies for histomorphometry and micro computed tomography (µCT), bone marrow aspirates~     for molecular studies, peripheral blood to detect circulating bone progenitor cells and dual~     X-ray absorptiometry. The investigators hypothesize that in humans, PTH will 1) increase bone~     progenitor number, 2) enhance recruitment of bone progenitor cells to bone resorption sites,~     and 3) increase bone progenitor number in peripheral circulation. Furthermore, the~     investigators hypothesize that ALN treatment will have the opposite effect. Understanding the~     differences in bone progenitor cell activity and recruitment during osteoporosis therapy will~     provide a mechanistic rationale for effective use of PTH and anti-resorptive drugs in~     osteoporosis treatment.~   "
145959|NCT01656616|"~     The costs to a rural emergency medical services (EMS) system of a change from a traditional~     cyanide antidote kit to a kit containing hydroxocobalamin alone are currently unknown. The~     purpose of this study is to use current EMS data to calculate the costs to a rural EMS system~     associated with the adoption of a hydroxocobalamin protocol for the treatment of suspected~     cyanide exposure.~   "
145960|NCT01656603|"~     This study will evaluate the safety of infusion of the investigational cord blood units by~     carefully documenting all infusion-related problems.~   "
145961|NCT01656590|"~     The research protocol will be submitted for approval to the institutional review board of~     Columbia University Medical Center. An attempt will be made to recruit at least 6 juvenile~     patients between the ages of 8 and 17, preferably who are still ambulatory.~      Subjects meeting all eligibility criteria will undergo a full history and physical~     examination, including details of age of onset of symptoms, distribution and severity of~     muscle weakness, muscle function, pulmonary function, and nutritional status. Subjects will~     undergo an electrocardiogram (ECG), spirometry, muscule strength evaluation, exercise~     capacity, functional muscle tests, laboratory tests, and muscle biopsy. Quality of life will~     be assessed via SF 36 questionnaire. Functional ability and level of handicap will be~     assessed by Rotterdam handicap scale. Written informed consent will be obtained from all~     subjects.~      All patients, who will have received enzyme replacement therapy (ERT) for at least 2 years,~     will be evaluated prior to institution of high protein nutrition and exercise therapy plus~     nocturnal enteral feeding (HPET + NEF)(baseline), then again at 3 months, 6 months and 12~     months into treatment. The following parameters will be evaluated-~        -  Skeletal Muscle Function~        -  Biochemical parameters from collected blood sample Muscle Biopsy will be obtained at~          baseline and at 12 months. Biopsy specimens, obtained from thigh muscle at baseline and~          a repeat biopsy of the corresponding area of the other leg at 12 months, will be~          analyzed as follows:.~        -  Histology and electron microscopy~        -  Autophagic and lysosomal function evaluation~        -  Body composition Body mass index (BMI), body composition, lean body mass, and fat mass~          will be measured at each visit by bioelectric impedance analysis using BI-101Q RJL~          Systems, software 3.1b~   "
145962|NCT01656577|"~     Background:~      - Stress can cause people to give in to temptations to eat less healthily. People who are on~     weight loss diets often have problems sticking to their diets when they are stressed. Some~     tests have shown that the drug pexacerfont can help reduce stress-related seeking of~     high-calorie foods. However, it has not been tested on reducing food craving. Researchers~     want to test pexacerfont on people who are on diets to see if it can reduce stress-related~     food cravings.~      Objectives:~      - To see if pexacerfont can help reduce stress-induced food cravings.~      Eligibility:~      - Individuals between 21 and 65 years of age who are on a diet to control their weight.~      Design:~        -  Participants will be screened with a physical exam and medical history. This study~          requires seven visits over about 35 days.~        -  Participants will take either pexacerfont or placebo pills during the study. They will~          have three pills every morning. They will record video of themselves taking the pills~          every day.~        -  Every evening, participants will fill out a questionnaire. It will ask questions about~          feelings and behaviors related to eating and food craving.~        -  Participants will have regular study visits while taking the pills. The visits will~          involve questions about stressful situations and food cravings. One visit will involve a~          mildly stressful math test, followed by tasting of different foods. This test will look~          at whether pexacerfont can affect food preferences. Participants will provide blood and~          saliva samples as directed at these study visits.~        -  Participants will have follow-up phone calls 1, 3, and 6 months after the end of the~          study.~   "
146071|NCT01655147|"~     The purpose of this study is to assess the effects of repeated daily administration of~     rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone~     following single-dose administration of abiraterone acetate tablets in healthy male~     participants.~   "
145963|NCT01656564|"~     Background:~      - Long-term survival with the human immunodeficiency virus (HIV) is not well understood.~     Adults who were infected with HIV as children have lived with the virus for many years.~     However, the effect of HIV on this group of people has not been studied in depth. Researchers~     are interested in studying how HIV infection and the medicines used to treat it affect people~     who were infected early in life. They want to find out if there are any problems with how~     HIV-infected children grow and develop as adults, especially if they have developed heart~     problems. As part of this study, people with HIV will be compared with healthy volunteers.~      Objectives:~      - To study the effect of HIV infection and treatment on people who acquired HIV infection in~     early life.~      Eligibility:~        -  Individuals at least 18 years of age who were infected with HIV before age 10.~        -  Healthy volunteers at least 18 years of age who have no history of heart disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will have~          regular study visits about once a year for up to 10 years to collect health information.~        -  Blood and urine samples will be collected to look at kidney and liver function.~        -  X-ray scans will be used to look at bone density and the amount of fat and muscle in the~          body.~        -  Heart function tests and imaging studies, including ultrasound and echocardiograms, will~          be used to look more closely at the heart.~        -  Treatment will not be provided as part of this study.~   "
145964|NCT01656551|"~     The purposes of this study are to test whether the addition of cisplatin to single agent~     chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with~     non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs~     survival as compared to gemcitabine in elderly patients with non squamous NSCLC.~   "
145965|NCT01656538|"~     Researchers doing this study want to evaluate the side effects of Reolysin when given~     together with paclitaxel. As these drugs have not been given together before, 6-9 patients~     will be treated with paclitaxel plus reolysin to ensure that side effects are tolerable.~   "
145966|NCT01656525|"~     Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and~     preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to~     moderate AD.~   "
145967|NCT01656512|"~     Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for~     one fourth of all childhood cancers & 74 % of childhood leukemia. Based upon drug registry~     data, children prescribed more than three courses of systemic glucocorticoids yearly faced a~     20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids~     were discontinued, and fracture rates returned to expected for age by 1 year after treatment~     (Journal Of Clinical Endocrinology & Metabolism 2009). The investigators will study the role~     of bisphosphonates in the prevention of secondary osteoporosis in children & adolescents~     treated for ALL in the Children's Cancer Hospital -Egypt.~   "
145968|NCT01656499|"~     The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism~     and gut health~   "
145969|NCT01656486|"~     Patients that have undergone pre-operative radiation for pancreatic carcinoma, that upon~     pathologic examination of the normal portion of the pancreatic gland that was in the~     radiation field showed acute and chronic changes in the pancreatic cells. The hypothesis for~     utilizing stereotactic radiation on pancreatic fistulae is that the treatment will decrease~     pancreatic secretions, thus decreasing autodigestion.~   "
145970|NCT01656473|"~     The purpose of this study is to evaluate the preliminary effectiveness and feasibility of an~     integrated treatment approach for youth with concurrent disorders. The combined intervention~     will include individual sessions of Motivational Interviewing, followed by inclusion in a~     Dialectical Behaviour Therapy skills-based group.~      The following main hypotheses will be examined:~        1. Youth with CD who receive an MI intervention will show increased motivation and~          readiness to change from pre to post MI intervention.~        2. Youth with CD who participate in a DBT intervention (orientation session followed by~          12-week DBT skills training group)will show reductions in substance use and improvements~          in mental health, coping and affect regulation between pre to post treatment. The~          investigators expect that these treatment gains will be maintained at three-month~          follow-up.~   "
145971|NCT01656460|"~     The purpose of this study is to evaluate the efficacy and toxicity stereotactic body~     radiation (SBRT) as consolidation following standard chemoradiation for patients with stage~     III non-small cell lung cancer.~   "
145972|NCT01656447|"~     The overall objective of the Scleroderma Registry is to support and promote the basic science~     and clinical research of this complex rheumatic disease at the Hospital for Special Surgery~     (HSS). The registry facilitates our understanding of the clinical features, pathobiology,~     genetics of Scleroderma. This will ultimately lead to a potential treatment for this~     currently untreatable condition.~   "
145973|NCT01656434|"~     The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate +~     17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active~     American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were~     assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol~     (NETA-EE) COC. The safety of NOMAC-E2 was also assessed.~      Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of~     Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio~     was adapted accordingly for participants randomized after the sample size increase.~   "
145986|NCT01656252|"~     Patients with Acute Myeloid Leukemia (AML) in complete remission will receive eltrombopag~     while undergoing consolidation chemotherapy with high-dose cytarabine. Eltrombopag may help~     increase the number of platelets during chemotherapy and may help prevent the risk of~     bleeding.~      Phase I will study the side effects, best dose and platelet effects of eltrombopag when given~     with consolidation chemotherapy. After the maximum safe and tolerated dose and schedule is~     found in Phase I, the study will proceed to Phase II. Phase II will confirm the dose and~     schedule of eltrombopag identified in Phase I that can increase platelet counts in patients~     receiving consolidation therapy.~   "
145987|NCT01656239|"~     The purpose of this study is to determine the dose level(s) of fedovapagon which result in a~     decrease in the mean nocturnal void frequency.~   "
145988|NCT01656226|"~     The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona~     AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis~     patients after 6 months of treatment.~   "
145974|NCT01656421|"~     Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of~     cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular~     disease is a major cause of death in such patients and it may be related to excess stiffening~     of the walls of major arteries, such as the aorta, and it has been suggested to represent~     premature aging. However, there is little known of the development of these problems, which~     were previously considered to be due to smoking and which is now known not to be the only~     factor. The investigators will study a large group of patients with mild to very severe~     airflow obstruction based on the NICE 2010 classification of severity and a matched~     comparator group free of COPD. This study involves three assessments of the development of~     the complications of COPD over a five year period. The key measure will be the rate of change~     in the aortic wall stiffness, an accepted indicator of the risk of heart disease. Changes in~     wall stiffness will be related to the severity of lung disease; other known cardiovascular~     risk factors, such as high blood pressure, increased blood cholesterol and to cardiovascular~     events including heart attacks and death; and to the presence of other complications, such as~     osteoporosis, muscle wasting and diabetes mellitus. These measures will be analysed in the~     context of changes in bodywide inflammation and metabolic function and the changes in the~     rate of ageing. This increased knowledge of interacting factors in the complications of COPD~     is likely to lead to studies of treatments to avoid their development.~   "
145975|NCT01656408|"~     This randomized, double-blind, placebo-controlled, multiple-rising-dose study will evaluate~     the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8150 in healthy young~     men, in male participants with mild to moderate hypertension, in elderly male and female~     participants with mild to moderate hypertension, and in male and female participants with~     resistant hypertension. A primary study hypothesis is that there is at least one dose that~     does not increase heart rate (HR) to a clinically meaningful extent in male participants with~     mild to moderate hypertension and in elderly participants with mild to moderate hypertension~     on either Day 1 or the last Day of multiple dosing (Daylast), as measured by Time-weighted~     Average Across 24 hours (TWA0-24hrs). The hypothesis is met if mean increase (MK-8150 -~     placebo) in TWA0-24hrs HR in the identified groups is ≤15 beats per minute on Day 1 and~     Daylast.~   "
145976|NCT01656395|"~     The purpose of this adaptive-design study is to evaluate the dose-related effectiveness and~     safety of MK-1029, alone or in combination with montelukast, compared to placebo and to~     montelukast alone, in the treatment of persistent asthma in adults.~   "
145977|NCT01656382|"~     The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7~     days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of~     patients with disseminated cryptococcosis and HIV.~   "
145978|NCT01656369|"~     The aim of the study is to compare Delorme operation alone or with post anal repair and~     levatorplasty for treating complete rectal prolapse.consecutive patients who were treated for~     complete rectal prolapse at the Colorectal Surgery Unit were eligible for the study.The~     patients were randomized into two groups: Group I: consisted of patients were subjected to~     delorme operation only. Group II: consisted of patients were subjected to delorme operation~     with post anal repair and levatorplasty.~   "
145979|NCT01656356|"~     The purpose of this study is to evaluate safety and reactogenicity of live attenuated~     influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO,~     in Thailand to previously healthy Thais.~   "
145980|NCT01656343|"~     -  To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD)~          in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept~          at the time of transplantation~        -  To estimate the incidence rates of PTLD in adult, EBV seropositive, kidney alone~          transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the~          time of transplantation~        -  To compare the PTLD incidence rates in adult, EBV seropositive, kidney alone transplant~          recipients treated with belatacept to the rates in adult, EBV seropositive, kidney alone~          transplant recipients treated with CNI-based regimens at the time of transplantation~   "
145981|NCT01656330|"~     The purpose of this study is to assess the use of 2 different Prothrombin Complex~     Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of~     rivaroxaban in healthy adult volunteers.~   "
145982|NCT01656317|"~     The study's main objective will be to assess which effect early initiated rehabilitation has~     on the frequency of complications and the level of physical and cognitive functioning after~     aneurysmal subarachnoid hemorrhage (SAH).~      To this end the following aspects will be investigated:~      The frequency of complications (with special emphasis on pulmonary~     complications,thromboembolic events, cerebral vasospasm, unintended discontinuation of drains~     and lines)~        -  Length of stay in hospitals and socio-economic impact~        -  Physical and cognitive function in the early and chronic phase after SAH~        -  Health-related quality of life and participation in society in the chronic phase~   "
145983|NCT01656304|"~     This pilot phase II trial studies how well giving bevacizumab works in treating patients with~     relapsed prostate cancer that did not respond to hormone therapy. Monoclonal antibodies, such~     as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or tumor-killing~     substances to them. Bevacizumab may also stop the growth of prostate cancer by blocking blood~     flow to the tumor~   "
145984|NCT01656278|"~     The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided~     treatment strategy based on a predefined treatment algorithm can prevent progression of~     erosive joint damage, increase remission rate and improve functional level in the short and~     long term in patients with rheumatoid arthritis (RA).~   "
145985|NCT01656265|"~     The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in~     hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the~     recommended dose of ARQ 197 in advanced HCC patients.~   "
146017|NCT01655849|"~     This study will compare Z160 and placebo in patients with Lumbosacral Radiculopathy for~     safety and efficacy for a period of 6 weeks.~   "
146116|NCT01654510|"~     The goal of the proposed research is to design and develop a culturally appropriate,~     vocationally focused, sustainable, cognitive-behavioral intervention for unemployed,~     economically disadvantaged, urban-dwelling persons whose job attainment efforts have been~     undermined by the presence of social anxiety disorder.~   "
145989|NCT01656213|"~     TITLE Randomised Control Trial (RCT) for improving functional outcome from stroke in renal~     disease patients DESIGN Eandomised Conrol Study AIMS~        1. Undertake detailed characterisation of stroke (including recently developed imaging~          techniques at Imperial) of stroke in renal disease patients including clinical, imaging~          and epidemiological data~        2. To Investigate if passive intervention using hand grip device during dialysis sessions~          will improve functional outcome from stroke in end stage renal disease patients.~      OUTCOME MEASURES~        1. Primary outcome:. 3 months change in Upper-Extremity Fugl-Meyer scores.~        2. Secondary outcome: 3 months change in NIHS & Bartel scores~      POPULATION Ischaemic and haemorrhagic stroke patients with renal disease treated at~     Hammersmith's Hospital's renal Unit. .~      ELIGIBILITY Data of all patients with renal disease and imaging proven stroke will be~     retrospectively analysed. RCT will be conducted on End Stage Renal Disease patients with~     acute (<7 days) stroke affecting arm.~      DURATION 2 years~   "
145990|NCT01656200|"~     Japanese encephalitis (JE) live attenuated vaccine SA14-14-2 has been in use for more more~     than 20 years in Asia. JE vaccine SA14-14-2 is licensed in India and has been widely used~     since 2006. JE vaccines give protection by generating a neutralizing antibody response, but~     both naturally exposed persons and patients with JE also have T cell responses. Whether JE~     vaccine SA14-14-2 elicits T cell responses is unknown. This study tests the hypothesis that T~     cell responses are generated in response to JE SA14-14-2 vaccination. The aim of this study~     is to characterize T cell responses to JE vaccine SA14-14-2 in healthy people, and to~     investigate differences in T cell responses between natural exposure, vaccination and~     disease.~   "
145991|NCT01656187|"~     The purpose of the study is to determine if an investigational drug called memantine,used~     here as add-on therapy, is associated with improvements in memory, mood and asthma symptoms.~     We will also examine changes in the brain by taking images or pictures using an MRI/MRS.~   "
145992|NCT01656174|"~     The objective of this study is to test individual donor samples (IDSs) with the~     investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue~     Assay in the clinical setting.~   "
145993|NCT01656161|"~     The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg~     6-month formulation administered by the subcutaneous (under the skin) route in:~        -  achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days~          after investigational medicinal product (IMP) injection], and~        -  in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month~          12 (Day 337) in participants with advanced prostate cancer.~   "
145994|NCT01656148|"~     Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two~     pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking~     speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk~     Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not~     been investigated in patients responding to the drug measured by the abovementioned test.~      The question is if this will be the case and also if another walking test, termed the Six~     Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.~      Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not~     less sensitive to the effect of Fampridine-SR than T25FW.~   "
145995|NCT01656135|"~     To investigate the progression of the immunological response in living-donor kidney~     transplant recipients treated with a standard immunosuppressive regimen. Clinical,~     immunological, and health-economic data collected during this Reference Group Trial will be~     used to corroborate historical renal transplantation statistics and generate reference ranges~     for future clinical studies that will test immunoregulatory cell therapy as an adjunct~     immunosuppressive treatment in renal transplantation.~   "
145996|NCT01656122|"~     The purpose of this study is to assess the pharmacokinetic parameters for ABC and 3TC in~     HIV-infected children younger than 18 years old with body weight ≥ 14 kgs.~   "
145997|NCT01656109|"~     There are no data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in~     HIV-infected Asian children. Therefore, the investigators aim to evaluate the~     pharmacokinetics, efficacy and safety of ATV/r-based HAART in Thai HIV-infected children.~   "
145998|NCT01656096|"~     The purpose of this study is to examine the benefit of renal sympathetic denervation in~     patients with mild refractory hypertension~   "
145999|NCT01656083|"~     Research indicated that the relapse rate of smokers who attempted to give up smoking without~     drug and other assistance is up to 90-95% while the successful cessation rate may be improved~     a lot with assistance to quit smoking. There are two kinds of measures to help smokers quit~     smoking: one is psychological and behavioral intervention, including the advice to quit~     smoking provided by doctors during daily health service and smoking cessation hotline;~     another is provision of drug therapy. 2008 smoking cessation Guidance plays emphasis on the~     effectiveness of smoking cessation of Varenicline and also on role of doctor's behavioral~     intervention in smoking cessation as Class A of evidence-based rating; among which, doctor's~     consultation (three minutes) at minimum intensity is effective; high-intensity consultation~     (more than ten minutes) is more effective than that of low-intensity consultation; and return~     visit for more than four times will distinctively improve the smoking abstinence rate. It is~     unrealistic to apply high-intensity and high-frequency smoking cessation intervention on all~     smokers due to the busy clinical work of domestic doctors. Systematic and standardized short~     message intervention system may be helpful to improve abstinence rate. Meanwhile, it can~     reduce human labor and physical resources, and improve the frequency of follow-up visit to~     smokers. It is observed during the process of offering smoking cessation services to smokers~     that, it would be one of the very effective measures to provide timely and useful information~     to smokers at several critical phases of smoking cessation course (such as three weeks before~     smoking cessation, prevention of relapse, etc.). Doctors, however, are usually passive during~     this period and unable to provide assistance to smokers with initiative. As people are more~     and more aware of the harmfulness of smoking and more and more smokers are increasingly~     willing to give up smoking, it is necessary to create an instant active information~     distribution system, which provides immediate active smoking cessation short message support~     through universally used mobile phone short message service to achieve the purpose of helping~     them quit smoking.~   "
146000|NCT01656070|"~     Along with its effects on bone metabolism, vitamin D is an important modulator of the immune~     system. Experimental studies have shown that the active metabolite of vitamin D [1,25(OH)2D]~     is able to skew the T cell compartment into a more anti-inflammatory state, with inhibition~     of Th1 and Th17 cells and promotion of Th2 and T regulatory subsets.~      In the context of HIV infection, in which Th1 subpopulations are devoted to inhibit viral~     replication, any alteration of the Th1/Th2 balance would be of concern.~      The aim of this Randomized Controlled Trial is to test wether oral supplementation with~     cholecalciferol could be able: 1) to improve vitamin D status and, 2) to play an~     immunomodulatory role, in vertically HIV-infected children and young adults with~     hypovitaminosis D.~   "
146001|NCT01656057|"~     The last couple of years it has been shown that bile acids not only acts as simple~     emulsifiers of fat, but constitutes a complex metabolic integrator which not only have an~     influence on fat digestion and lipid metabolism, but also modulates the energy expenditure in~     (brown) adipose tissue and muscle tissue. This action is due to stimulation of the receptor~     TGR5 by bile acids. Recently scientists have discovered that this receptor in rodents is also~     expressed on the surface of intestinal L-cells (which normally secrets Glucagon-Like~     Peptide-1 (GLP-1) in response to nutrient stimulation). The stimulation of this receptor has~     shown a GLP-1 secretion from the intestinal cells which is interesting since GLP-1 has a~     central role in maintaining normal glucose tolerance and thus blood sugar. Given the above,~     bile acids has an important impact on intestinal GLP-1 secretion. Whether these scientific~     findings can be proven in human beings is uncertain.~      The primary hypothesis is that stimulating gall bladder emptying via Cholecystokinin (CCK) in~     healthy subjects will result in a significant GLP-1 response. We also hypothesize that adding~     orally Metformin or a sequestrant (a bile acid binder) will further enhance this GLP-1~     response.~   "
146002|NCT01656044|"~     The purpose of this research study is to evaluate if a negative-pressure dressing placed over~     a surgical incision can reduce the risk of developing a surgical site infection compared to a~     commonly-used sterile gauze incision dressing. In this study, the negative-pressure dressing~     will be compared to a standard post-surgical sterile gauze dressing. In this study patients~     will either receive a negative-pressure dressing or a standard sterile gauze dressing~   "
146003|NCT01656031|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to~     see how well they work in treating patients with refractory or relapsed acute myeloid~     leukemia or acute lymphoblastic leukemia.~   "
146004|NCT01656018|"~     The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what~     the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics~     (what the medication does to the body) of TMC278 long acting (slowly effective after initial~     dosage and maintaining its effects over a long period of time) when administered as an~     intramuscular (ie, in to the muscle) injection in adult participants who are seronegative for~     human immunodeficiency virus type 1 (HIV-1).~   "
146005|NCT01656005|"~     Beta blockers are a type of medication mainly used for heart disease. They are commonly used~     to treat 'angina' and to prevent heart attacks. Patients with COPD are more likely to suffer~     from heart disease and so already benefit from this treatment for this reason. In addition to~     this, new research suggests that there may be further benefit of using beta blockers for~     COPD, even without also having heart disease.~      The reason why beta blockers are not widely used in COPD at present is because of their~     potential to make symptoms of COPD worse by causing the airways to narrow. Beta blockers are~     the opposite type of medication to 'beta-agonists' such as salbutamol which you may be taking~     for symptoms of breathlessness or wheezing. Nevertheless beta blockers are still used in COPD~     where the benefits (for example heart disease) outweigh any risks.~      Current COPD treatment includes inhaled steroids and long acting beta agonists, often given~     in a combination inhaler (e.g. Seretide or Symbicort) to treat both airway inflammation and~     airway narrowing, leading to improvement in symptoms. Another drug commonly used is~     Tiotropium (Spiriva) which is another type of long acting inhaler medication to help with~     widening the airways.~      In this study, we wish to find out if two different types of beta blocker cause different~     effects on the airways in COPD patients. One type of beta blocker is more 'selective' in~     acting mainly on the heart, with the other type having more general or 'non-selective'~     effects on both the heart and lungs. By doing this we will also be able to look at how the~     beta blockers work alongside the 'usual' inhaler treatment described above.~   "
146006|NCT01655992|"~     Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.~   "
146007|NCT01655979|"~     The human being has shown that he can live and work in the space environment, but due to the~     lack of essential mechanical load on muscle and bone, the fluid-shift as well as alterations~     in the acid-base balance (mainly on account of nutritional factors), the exposure to~     microgravity results in a gradual degradation of muscle, bone and cartilage, deconditioning~     of the cardiovascular system and metabolic changes. Countermeasures to prevent all the~     deconditioning of the physiological systems are not yet fully effective and require further~     investigation.~      A commonly utilized model of simulating the physiological effects of microgravity on the~     human organism on ground is the 6° head-down-tilt bed rest. In the present study the model~     has been used to study potential countermeasures to spaceflight-associated deconditioning.~      One of the most constrictive changes appearing during space flight as well as during bed~     rest, are disuse-induced muscle losses. These are associated with a decrease in muscle~     protein synthesis, rather then an increase in muscle protein breakdown. Besides an effective~     training countermeasure, nutritional countermeasures gain respect in this context:~     supplementing conventional diets with whey protein or essential amino acids has been shown to~     increase muscle protein synthesis. Due to these anabolic properties whey protein seems~     promising to counteract disuse-induced muscle wasting.~      Drawbacks of a high protein intake are calciuric effects, ascribed to the proton-release when~     metabolizing sulfur-containing amino acids. The so called 'low grade metabolic acidosis' has~     also shown to activate osteoclastic bone resorption and muscle protein degradation.~     Therefore, to maximize the anabolic potential of a whey protein supplementation, the~     acidogenic properties need to be compensated. As previous works suggest, a shift of acid base~     balance into the acid direction and the resulting changes in bone and protein turnover may be~     hindered by supplementing alkaline mineral salts.~      In this regard, a mid-term bed rest study was performed in order to investigate the effect of~     a combined whey protein (0.6 g/kg body weight/day) and potassium bicarbonate (90 mmol/day)~     supplementation as a potential countermeasure to multiple physiological and metabolic~     alterations on the human body resulting from real and simulated microgravity.~   "
146008|NCT01655966|"~     Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4.~     Conventional standard of care treatment has modest response with only 50% sustained virologic~     response. Recent reports have suggested an augmented response with the addition of vitamin D.~     This is a prospective randomized trial to assess the effectiveness of adding vitamin D to~     standard of care for chronic hepatitis C genotype 4.~   "
146018|NCT01655836|"~     The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes~     called internal radiation therapy. High dose rate brachytherapy is a procedure that involves~     temporarily placing radioactive material inside the patient's body for about 10-20 minutes.~     Then, the remainder of the radiation treatment will be given over a 3 week period using~     stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves~     the delivery of very high individual doses of radiation to tumors with high precision. This~     allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose~     of this study is to determine the safety of brachytherapy when combined with hypofractionated~     SBRT.~   "
146009|NCT01655953|"~     The study aimed to examine the effects of an alkalinisation of a NaCl (sodium chloride,~     salt)-rich diet on acid base status, bone metabolism, protein turnover and other influenced~     physiological systems. Due to increased urinary calcium excretion and bone resorption a high~     NaCl-intake is considered as a risk factor for osteoporosis. On the contrary an alkaline diet~     is known to have a beneficial influence on bone metabolism. Therefore the investigators~     hypothesized that an alkaline diet can reduce NaCl-induced bone resorption.~      8 healthy male volunteers took part in a stationary study carried out in the metabolic ward~     of the German Aerospace Center. The study consisted of 2 campaigns, each lasting 16 days.~     Both campaigns were divided into 5 days of adaptation, 10 days of intervention and 1.5 days~     of stationary recovery. During the intervention period the volunteers diet was NaCl-rich (7.7~     mmol Na/kg body weight/day) and supplemented in one campaign by 90 mmol potassium bicarbonate~     (KHCO3) in a randomized cross-over design. The other campaign served as control.~      Bone metabolism was studied by bone formation markers in the fasting morning blood and~     24h-urinary bone resorption markers. Acid base status was assessed by blood gas analyses in~     the fasted and the postprandial state as well as urinary markers. Protein turnover was~     studied with stable isotopes. Further physiological systems like energy metabolism and the~     cardiovascular system are also under investigation.~   "
146010|NCT01655940|"~     In this prospective study to try to standardize the care for patients, the investigators are~     planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy~     in determining the cerebral oxygen saturation as determined by jugular bulb oxygen~     saturation. Also, the investigators will compare these devices in terms of their response to~     changes in hemodynamics that occur during cardiac surgery.~   "
146011|NCT01655927|"~     The purpose of this study is to determine whether Tranexamic Acid is effective or not in the~     reduction of intraoperative bleeding loss in brain tumors resections.~   "
146012|NCT01655914|"~     This study compare the pharmacokinetic (PK) profile of sublingual CRLS035 (two doses) to I.V~     flumazenil administration.~      Selection of study drug dosage: CRLS035 - sublingual Flumazenil will be administrated at a~     final dosage of 1.1 mg per 100 µl and 2.2 mg (200 µl) in a sublingual spray administration.~      Currently, Flumazenil is given as an IV drug with a repetitive administration of doses of 0.2~     mg up to 3 mg per hour. As the bioavailability of Flumazenil is expected to be lower than the~     IV administration, 1.1 mg and 2.2 mg will be tested in sublingual delivery. The suggested~     doses in this study are very safe according to the following data: first, sublingual and~     buccal administration of Flumazenil have been detailed previously with similar and higher~     doses with no side effects, secondly, IV dose may reach 3 mg and thirdly, oral administration~     has been reported as up to 600 mg/dose.~      The purpose of this study is to determine the single dose PK profile of SL CRLS035. This~     study is designed to collect short-term safety data and to monitor the PK profile of CRLS035.~      Primary Objective The primary objective is to determine the single dose safety and PK profile~     of SL CRLS035 using the marketed IV flumazenil formulation as the comparator.~      Secondary Objectives The secondary objectives are to (1) characterize the concentration time~     course of two dose levels of SL CRLS035 to support dose selection for Phase 2 and 3 studies~     and to evaluate the safety and tolerability of flumazenil formulations; (2)To evaluate the~     effect of high fat diet and water consumption on the PK profile.~   "
146013|NCT01655901|"~     STATEMENT OF THE PROBLEM: Video games have enormous mass appeal, are omnipresent in the daily~     schedule of most children and youth and have been linked to the obesity epidemic. The~     investigators research group recently reported that sedentary video game playing increases~     food intake in adolescents. Interestingly, the overconsumption of food associated with seated~     video game play was observed without increased sensations of hunger and appetite, as~     previously observed with television viewing. Active video games offer an appealing~     opportunity for increasing energy expenditure and promoting healthy body weight among~     children and youth who might otherwise be spending time in sedentary screen-based activities.~     However, significant increases in energy expenditure as a result of active video game play~     might be of little importance to energy balance if one compensates by increasing energy~     intake and/or decreasing physical activity. Studies to date have failed to measure energy~     intake so it is currently unknown the effects of active video games on daily energy balance.~      OBJECTIVE: The main aim of this study is to examine the acute effects of playing active video~     games on energy intake and expenditure.~      HYPOTHESIS: The investigators hypothesize that the increase in energy expenditure promoted by~     active video games will be offset by compensatory adjustments in food intake and spontaneous~     physical activity subsequent to the intervention.~      RESEARCH PLAN: With the use of a randomized crossover design, 30 normal-weight and 30 obese~     adolescents between 13 and 17 years of age will complete three 1-hour experimental~     conditions, namely (1) resting in a sitting position (control condition), (2) playing Xbox~     360 (sedentary video game condition) and (3) playing Kinect (active video game condition),~     followed by an ad libitum lunch. The primary outcomes will be acute (24-h) and short-term~     (3-day) energy intake and expenditure. Food intake will be measured using an ad libitum test~     meal immediately following the intervention, a food menu for the remainder of the day and a~     dietary record for the subsequent 3-day period. Energy expenditure will be measured using~     indirect calorimetry during the intervention and an Actical accelerometer for the subsequent~     3-day period. Secondary outcomes will include appetite sensations (visual analogue scales),~     stress markers (heart rate variability, blood pressure, and mental workload), and levels of~     appetite-related hormones and substrates (glucose, insulin, cortisol, leptin, and ghrelin).~      RELEVANCE: The present study is innovative and likely to result in a number of new and~     important findings that can inform future recommendations. If the investigators confirm our~     hypothesis, the clinical implication will be to rethink the strategy of promoting active~     video games as an intervention tool for the prevention of overweight and obesity in youth.~   "
146014|NCT01655888|"~     RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of~     tremelimumab in malignant mesothelioma (MM) patients.~      PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive~     schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive~     investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until~     confirmed disease progression.~   "
146015|NCT01655875|"~     This study is for patients 2-21 years old who have acute leukemia that has not responded well~     to chemotherapy and will have a bone marrow transplant. This is a pilot (phase 1) study of~     AMD3100(also called Plerixafor, Mozobil). AMD3100 is given in combination with a standard~     pre-transplant conditioning regimen (total body irradiation, etoposide and cyclophosphamide).~     The conditioning regimen is the treatment that is given just before the transplant. This~     treatment kills leukemia cells as well as healthy bone marrow and immune cells. Researchers~     want to learn more about how AMD3100 affects acute leukemia cells. Blood and bone marrow~     samples from study participants will be collected to find out if AMD3100 is making patients'~     cells more sensitive to the conditioning regimen and to find out how it does this.~      The first six patients receive three daily doses (240 mcg/kg via IV). If it appears that~     three doses do not significantly increase the side effects of transplant conditioning, the~     investigators will give a second group of six patients five daily doses.~   "
146016|NCT01655862|"~     This is an observational study to assess health-related quality of life in patients with~     cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.~   "
146019|NCT01655823|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of~     many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin,~     bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in~     greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing~     is often either decreased or discontinued potentially affecting tumor responsiveness,~     prognosis, and survival.~      There is an unmet medical need for treatment of cancer patients with chemotherapy induced~     neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of~     multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic~     pain caused by chemotherapy.~   "
146020|NCT01655810|"~     African-Americans have higher rates of cardiovascular disease morbidity and mortality, as~     well as vitamin D deficiency. Multiple observational studies have demonstrated an increased~     risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation~     between cardiovascular disease and vitamin D levels; however, there is a lack of~     interventional trials exploring this connection. The objective of this proposal is to address~     the hypothesis that treatment of vitamin D deficiency in African Americans with type 2~     diabetes will improve subclinical markers of cardiovascular disease.~   "
146021|NCT01655797|"~     The aim of this study was to investigate the clinical effectiveness of protocol-driven~     cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel~     (primary care nurses and social workers) in general medical practice with unselected~     patients, in line with a stepped care approach. The study design was a randomised controlled~     parallel group design, with allocation to CBT and waiting list control group (WL). Following~     an active treatment-control period, the control group were re-assigned to CBT. The study~     hypothesis was that the CBT group would experience less symptoms of insomnia after treatment~     compared with the WL group. Primary outcome measure was a brief self-report screening form,~     Insomnia severity index.~   "
146022|NCT01655784|"~     This trial is being conducted in order to compare angiographic outcomes in patients receiving~     0.014-0.0155 platinum framing and filling coils (larger diameter coils) versus those treated~     solely with coils less than 0.014 (with a standard diameter).~      Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients~     receiving 0.014-0.0155 platinum coils during embolization compared to those receiving~     smaller-diameter coils.~   "
146023|NCT01655771|"~     The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated~     by the body and to evaluate whether it is safe and well tolerated.~   "
146024|NCT01655758|"~     This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of~     drugs acting either on aqueous humor production (inflow drugs) or on aqueous humor outflow~     (outflow drugs) in human eyes affected by ocular hypertension and virgin to treatment. The~     enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and~     n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured. It is hypothesised that~     outflow drugs may offer a better and more stable control of IOP through the 24 hours.~   "
146025|NCT01655745|"~     This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma~     of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This~     pilot study is designed to provide preliminary information on the accuracy of [18F]~     Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of~     muscle-invasive bladder cancer.~   "
146026|NCT01655732|"~     S. mutans counts have been found to be high in women with high level of untreated caries. In~     Pakistan 95% of all carious lesions are untreated that is an alarming situation. A majority~     of mother's have high level of caries and pose an increase risk of vertically transmitting it~     to their children. Therefore, the aim of this study is to determine the effect of A Traumatic~     Restorative Treatment(ART) in reducing S. mutans count in pregnant women and indirectly~     reduce the vertical transmission of S. mutans to their children so that ART as a preventive~     program may be provided and promoted in periurban areas where there is a lack of~     accessibility to oral health care.~   "
146027|NCT01655719|"~     Through this trial the investigators hope to learn if a drug, Actos (pioglitazone), is useful~     in treating a certain kind of metastatic thyroid cancer. Actos is approved by the FDA to~     treat diabetes. It has not been approved by the FDA to treat cancer, so its use in this study~     is considered experimental.~   "
146028|NCT01655706|"~     This study is a pilot to assess feasibility of the protocol in patients and controls across~     six participating sites. The goal is to identify biological markers (biomarkers)that can be~     measured at baseline or early in treatment to predict treatment outcome in individual~     patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using~     interview and self-report measures), molecular (from blood samples) and neurobiological~     (using neuroimaging and EEG).~   "
146029|NCT01655693|"~     The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is~     effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma (HCC)~     after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis and~     with good liver functions are eligible. Only those who can not benefit from treatment for~     which efficacy is demonstrated are eligible.~      These patients are usually proposed either best standard of care (BSC) or participation to~     clinical trials. Patients eligible for the RELIVE study will receive either DT at 20 mg/m2 or~     DT at 30 mg/m2 or the BSC.~   "
146030|NCT01655680|"~     This is a safety and efficacy study evaluating a experimental treatment for cognitive~     deficits in adults with schizophrenia.~   "
146031|NCT01655667|"~     To characterise and understand the current UK COPD population including demographics, active~     comorbidities and missed opportunities for COPD diagnosis in the years previous to diagnosis~   "
146042|NCT01655524|"~     The investigators developed a modified regadenoson nuclear stress test of the heart that~     incorporates an aminophylline injection following regadenoson (The ASSUAGE protocol). The~     modified (ASSUAGE) protocol has been associated with fewer side effects and was better~     tolerated by patients.~      This study will investigate whether the modified regadenoson stress protocol (ASSUAGE)~     produces blood flow pattern to the heart similar to that of a standard regadenoson stress~     protocol. In proven to be the case, the ASSUAGE protocol has the potential to be used on a~     wide scale instead of the current standard protocol.~   "
146043|NCT01655511|"~     This study in healthy male and female volunteers will investigate the safety and tolerability~     of three increasing oral doses of tafamidis~   "
146032|NCT01655654|"~     The primary purpose of this study is to identify the percentage of health care workers~     working in an acute care hospital who have high blood pressure, to determine the awareness of~     their blood pressure status, and to see how well it is managed. Study participants will come~     from the following three distinctly different types of departments: telemetry (clinical),~     non-telemetry (clinical), and non-direct patient care staff. All study participants are~     offered educational information surrounding high blood pressure and review the recommendation~     for their primary care engagement. Study participants with high blood pressure will be asked~     to continue in the study for up to 6 months. It is intended that each study participant who~     continues will take their blood pressure three times a day and record the results in a study~     provided diary. Each study participant should also make some of the suggested changes that~     promote a healthier lifestyle including exercising, improving their diet, and seeing their~     primary care provider. It is the thought that these changes will reduce the study~     participant's blood pressure. The secondary purpose is to determine the effect shift work has~     on these hospital employees and the potential positive effects of the three interventions.~   "
146033|NCT01655641|"~     Primary objective of the study is to compare requirement of blood transfusion and mortality~     in patients receiving Tranexamic acid (Cyklokapron®) and those not receiving it.~      Secondary objective is to; assess the re-bleeding events; need for surgical intervention;~     length of stay in Intensive care unit in between the two groups.~   "
146034|NCT01655628|"~     Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in Southern China~     and South Asia. After radiotherapy, some patients with nasopharyngeal carcinoma still had~     distant metastasis. In recent years, some chemotherapeutic agents, such as gemcitabine,~     cisplatin, were used to treat patients with advanced nasopharyngeal carcinoma, including~     those with local recurrence and distant metastases, with a certain short-term effect.~     However, chemotherapy alone is still not ideal for effectively improving the prognosis of~     patients with advanced nasopharyngeal carcinoma. Therefore, it is necessary to develop~     more-effective adjuvant therapies.~      CIK cells (cytokine induced killer cells, CIK) are a population of heterogeneous cells~     generated by the in vitro amplification of mononuclear cells in peripheral blood. The cells~     are co-induced with multiple cytokines; the lymphocytes with co-expression of CD3+CD56+ have~     the strongest anti-tumor effect. Because of their non-MHC restricted tumor killing activity,~     CIK cells have a powerful anti-tumor effect both in vitro and in vivo, which spans a broad~     anti-tumor spectrum.~      In this study, the patients with post-radiotherapy distant metastasis of NPC will be treated~     with autologous CIK cells in combination with Gemcitabine plus Cisplatin regimen~     chemotherapy(GC). The purpose of this study is to observe and evaluate the toxic side effects~     and the short- and long-term efficacy of CIK used in combination with GC chemotherapy to~     treat NPC in patients with distant metastasis after radiotherapy. Patients and Methods: 40~     patients with distant metastasis after radiotherapy will accept 4 cycles chemotherapy of~     Gemcitabine plus cisplatin regimen and then are randomized divided into 2 groups. The 20~     patients in GC+CIK group will be treated with maintaining therapy of adoptive autologous CIK~     cell transfusion sequentially; the other 20 patients will be followed-up only without CIK~     cells treatment. The safety of chemotherapy and CIK cells transfusion and the tumor~     regression status will be observed. The early response and long-term efficacy of two groups~     patients who accept GC chemotherapy or GC +CIK bio-therapy will be investigated.~   "
146035|NCT01655615|"~     The Preventure Program is the first and only school-based alcohol and drug prevention program~     that has been shown to prevent onset and growth in alcohol and substance misuse in British~     and Canadian youth. Unlike universal programs that tend to promote generic coping skills and~     balance normative attitudes around substance use, this selected personality-targeted approach~     is based on a psychosocial model and validated by Dr Patricia Conrod and targets four~     personality-specific motivational pathways to substance misuse: Hopelessness, Anxiety~     Sensitivity, Impulsivity and Sensation Seeking, each associated with different motives for~     substance use, drug use profiles and patterns of non-addictive psychopathology.~      As a primary goal of the Coventure project, the investigators propose a long-term trial of~     this intervention strategy to examine how this evidence-based intervention can reduce onset~     of substance use disorders in young people and related secondary mental health, academic and~     cognitive outcomes.~      As a secondary goal, the investigators propose to use sensitive neuropsychological measures~     to examine how this evidence-based intervention can positively impact on cognitive~     development over the course of adolescence, to tease apart some of the mechanisms involved in~     the causal pathway from early onset substance use to poor cognitive development and long-term~     addiction outcomes.~   "
146036|NCT01655602|"~     This study aim to compare cosmetic results between 3 trichophytic closure techniques for~     donor site (the trimming of upper, lower and both edge of linear incision) in hair~     transplantation.~   "
146037|NCT01655589|"~     The main purpose of this study is to investigate the association between VEGF gene~     polymorphism and the response to intravitreal drugs in neovascular age-related macular~     degeneration. This is a retrospective review of patients treated between 2008 and 2012 at the~     Institute of Vision, in Belo Horizonte, Brazil.~   "
146038|NCT01655576|"~     The purpose of this study is to determine if placental drainage shortens third period of~     labor and reduces postpartum blood lost.~   "
146039|NCT01655563|"~     Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid~     organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus~     through genetics will help in early attainment and maintenance of the correct dosage level in~     the early post-transplant period. This pilot dose-finding trial will help to determine a~     dosing strategy guided by genotypes and age for solid organ transplant recipients that will~     be further validated through a multi-centre trial as an immediate next step. The study~     hypothesizes that dosage levels determined through age and genotype will be attained faster~     and more accurately than the standard dosing procedures in the 14-days after the transplant.~     Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster~     recovery (tested through the kidneys' ability to clear creatine from the blood) and result in~     lower frequencies of adverse effects and rejection of the transplant.~   "
146040|NCT01655550|"~     The investigators seek to demonstrate the non-superiority of oral contrast versus no oral~     contrast in intravenously enhanced CT in the outpatient setting. The investigators want to~     decrease preparation time for the patient and decrease delay in obtaining the study which~     will ultimately lead to faster results and an increased level of patient convenience.~      The investigators hypothesis: Oral contrast does not significantly affect the diagnostic~     confidence of interpreting radiologists in intravenously enhanced abdominal CT scans.~   "
146041|NCT01655537|"~     Fibromyalgia is a common rheumatologic disorder. Many patients complain of cognitive~     dysfunction as part of their symptoms.~      The investigators aim to assess this cognitive dysfunction through extensive neuro-cognitive~     testing.~   "
146044|NCT01655498|"~     The objective of this study is to obtain preliminary efficacy and safety data on the use of~     the LivSure System (now called the Eclipse™ System) in women with fecal incontinence.~   "
146045|NCT01655485|"~     The purpose of the research is to test the effectiveness of the social story intervention~     delivered using the iPAD application Going to Imaging on the anxiety, challenging child~     behaviors, child injuries and completion rates among children with ASD undergoing medical~     imaging procedures. A secondary purpose is to test the effect of this intervention on the~     anxiety levels of the parents of ASD children undergoing medical imaging procedures.~      Hypotheses:~      H1: Children with ASD who are exposed to a story book Here the investigators go to medical~     imaging (x-ray) to prepare for medical imaging compared with children with ASD exposed to~     treatment as usual (TAU) will have:~        1. Lower anxiety as measured by heart rate respiratory rate, and blood pressure (baseline~          compared to up to two hours later).~        2. Exhibit fewer challenging behaviors as measured by a behavior observation scale~          (developed for the study (up to 2 hours after baseline)~        3. Higher procedure completion rate.~        4. Shorter time to complete a procedure.~        5. Less child injuries.~           H2: Compared to parents of ASD children exposed to treatment as usual (TAU), parents of~          children with ASD who are exposed to a story book Here the investigators go to medical~          imaging (x-ray) to prepare for medical imaging will have:~        6. Lower state anxiety as measured by the State Anxiety Inventory ( baseline ).~   "
146046|NCT01655472|"~     Schizophrenia is a common disorder with a lifetime prevalence of about 1%.Genetic studies~     strongly suggest a genetic component to the inheritance of schizophrenia. Structural~     neuroimaging studies have provided consistent evidence for brain abnormalities in~     schizophrenia. The timing of brain abnormalities in schizophrenia has not been determined~     yet.~      The investigators hypothesize that brain structural changes can be detected in neonatal life.~     The investigators hypothesize that offspring of schizophrenic patients will have higher rates~     of brain structural changes in the neonatal period. The investigators propose to study early~     development of fetuses in offspring of patients with schizophrenia. The study is a~     multi-center prospective trial.~   "
146047|NCT01655459|"~     Introduction: Although the LMA insertion is not difficult and majority of the cases with LMA~     fare well in ventilation, the FOB assessment demonstrates a high incidence of LMA~     malpositioning. The LMA must be seated at the laryngeal inlet with the occlusion of~     esophageal inlet by the inflated tip. When we meet the signs of LMA malposition, we then~     reinsert the LMA. The laryngoscopic grading of Rowbottom et al. is commonly used for LMA~     position, but the rotated degree of LMA was not considered in that grading. We hypothesized~     that the LMA can affect the position of the arytenoids/thyroid cartilages and it may be~     detected on ultrasound. This study was designed to assess the predictability of the rotated~     LMA according to the position change of arytenoids/thyroid cartilages using ultrasound.~      Methods: Children, aged 1 ms - 6 years, undergoing infraumbilical surgery were enrolled to~     this study. Ultrasound was performed on supraglottic and vocal cords area before and after~     LMA insertion. Transverse images were obtained on end-expiratory phase. LMA-position was~     evaluated with Bonfils fiberscopy. Position grading was made as usual. If grade >3 was~     showed, LMA was repositioned while fiberscopic watching. If the face of LMA was rotated to~     one-side, the LMA was rotated to the opposite side a little. The ultrasound findings of pre-~     and post-LMA were compared. On fiberscopic images, conventional LMA grade and the degree of~     rotation were measured.~   "
146048|NCT01655446|"~     The purpose of this proposal is 1) to compare the relative effects of the robotic~     rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare~     the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the~     RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will~     potentially influence the functional outcomes after interventions.~   "
146049|NCT01655433|"~     This study will look at the safety of treating patients with heart attack with mild~     hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the~     Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and~     with adequate performance.~   "
146050|NCT01655420|"~     This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related~     quality of life (QoL) of 300 civilian participants prior to and three months following~     state-of-the-art laser in situ keratomileusis (LASIK).~   "
146051|NCT01655407|"~     The purpose of this research study is to test how well the investigational treatment,~     Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds.~      The areas of the body that are treated with ESS-W will be compared to similar areas treated~     with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG) will~     be performed by taking healthy skin from one area of the body and placing it on the burned~     area.~   "
146052|NCT01655394|"~     IVIg exert a variety of different immunomodulatory effects and several mechanism of action~     have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in~     patients with immune-mediated neuropathies will be explored.~   "
146053|NCT01655381|"~     This open-label, single arm, multicenter long-term extension study will evaluate the safety~     and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe~     rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible~     participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104~     weeks.~   "
146054|NCT01655368|"~     This multi-center, 2-arm interventional study within different mental health care settings~     (psychiatry: in-patient, day-unit and out-patient, as well as psychiatric rehabilitation)~     evaluates a psychotherapeutic group intervention to improve stigma coping and empowerment~     using a psychotherapeutic module embedded in a psychoeducational group therapy.~   "
146055|NCT01655355|"~     Between the years 1999-2011 70 patients went through a revision of the hip joint(revision~     after not successful Total or Partial Hip Replacement). During the revision the Acetabular~     implant was found to be stable and it was decided not to replace it. The polyethylene insert~     was replaced and was fixated using a cement. Our purpose is to evaluate the physical~     condition of these patients.~   "
146056|NCT01655342|"~     Clinical and radiographic assessment of Biodentine® as a pulp dressing material for pulpotomy~     treatment in human primary molars.~   "
146069|NCT01655173|"~     The purpose of this study is to determine if adults with autism spectrum disorder and with~     normal intelligence improve from 36 sessions (1 calendar year) of group treatment with~     Cognitive Behavioural Therapy or recreational activity in groups with 6-8 participants.~   "
146057|NCT01655329|"~     This is a study to determine whether or not a new type of software is, or is not, of benefit.~     The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect~     tubes, lines and wires that may be placed within a patients chest. These types of devices are~     commonly used for very sick patients in intensive care units and are also used following~     surgery and in the treatment of cancer. This study will test radiologist's detection of the~     tips of these devices comparing the results with standard chest radiographs and the the~     modified chest radiographs. The primary interest is in the time used to interpret the~     radiograph. We will determine if there is any change in accuracy of detection.~   "
146058|NCT01655316|"~     PSVT is a common rhythm disorder in emergency department which can be recurrent in some~     cases.~      Intravenous Adenosine is the drug of choice in PSVT control in acute settings but is a very~     short acting agent.~      Providing a complementary medication to decrease the rate of recurrence of PSVT after its~     initial control will be promising.~      This study evaluates the role of the oral Verapamil in recurrence control of PSVT in~     emergency situations.~   "
146059|NCT01655303|"~     Rate control in atrial fibrillation is a usual battle in emergency departments. Oral~     medications have a natural superiority to intravenous ones because they are easy-to-use and~     decrease the workload in busy emergency departments.~      This study wants to find an effective oral medication for rate control in rapid ventricular~     response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are~     compared in patients with a stable hemodynamic status.~   "
146060|NCT01655290|"~     This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate~     dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed~     enhancement cardiac Magnetic Resonance Imaging~   "
146061|NCT01655277|"~     Our objective was to determine if an ultrasound guided ACB can preserve quadriceps strength,~     thus minimizing weakness of knee extension compared with ultrasound guided femoral nerve~     block. Our primary outcome was the percent of maximum voluntary isometric contraction (MVIC)~     of knee extension preserved at 30 mins after either an ACB or FNB. Secondary outcomes~     included MVIC of knee extension at 60 min, hip adduction at 30 and 60 mins, and assessment of~     fall risk with the Berg Balance Scale (BBS) at 30 minutes.~   "
146062|NCT01655264|"~     The overall goal of the study is to evaluate the clinical effectiveness of a home-based~     tele-motion-rehabilitation (TMR) program in improving functional status of people who had~     stroke. We hypothesize that the clinical effectiveness within a mock-up set up in the~     hospital of the TMR will be greater in comparison to self-training exercise carried out at~     home in improving outcomes of Range of Motion and functional performance of the weak upper~     extremity.~      Twenty-four subjects who had a stroke, aged between 18 and 80 years, and living at home will~     participate. Subjects will be 2-72 months post stroke, and no longer receiving rehabilitation~     as in or out patient. They will have moderate impairment of the affected upper extremity~     determined by range of motion (ROM). Subjects will be evaluated for motor and cognitive~     abilities for a total of 5-6 hours by a skilled therapist who will be blind to group's~     assignment of the subjects. The evaluations will be repeated 3 times, once before the~     intervention commences, once immediately following the intervention and once four weeks after~     the intervention.~      Subjects will be randomized into the two groups (TMR versus self-training treatment) with~     matching for level of impairment of the upper extremity by a person who is not part of the~     study. Each subject will receive twelve 45-60 min sessions over 4 weeks while seated. The~     control group will receive self-training exercises that are based on conventional therapy~     using principles of motor control and will include training of upper extremity movements in~     order to achieve better use of the affected arm in ADL. The experimental group will receive~     TMR treatment of comparable duration and intensity to those in the conventional treatment~     group with remote online monitoring by the therapist. Treatment feedback will be given in the~     form of Knowledge of results (game scores) and Knowledge of performance (feedback of~     compensatory movements made while using the upper extremity) to enhance motor learning. The~     software will generate a report which will include the duration and type of exercises~     performed by the subject.~      The Gertner TMR system is implemented via Microsoft's Kinect three-dimensional) camera-based~     gesture recognition technology. Using the patient's natural hand and body movements control~     all activity within customized computer games. The system runs off a standard desktop~     computer and is displayed on a large television screen.~   "
146063|NCT01655251|"~     To evaluate the effect of video discharge instructions on return visits to the ER or ED~     within 72 hours of the original visit for children with febrile illnesses.~   "
146064|NCT01655238|"~     The investigators are concerned about anesthetizing obese children in outpatient locations in~     case they need prolonged stay, increased respiratory interventions, or need for~     post-operative narcotics. The investigators will be using a screening guideline to help us~     determine the higher risk child based on BMI and co-morbid conditions. The investigators will~     also be doing a retrospective chart review of 300 patients with BMI 95% and looking at~     various factors during the operative and post-operative period.~   "
146065|NCT01655225|"~     The purpose of this study is to find a recommended dose level and schedule of dosing~     LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The~     study will also explore the changes to various markers in blood cells and potentially tumor~     cells. Finally, the study will help document any antitumor activity this drug may have.~      In Part A of this study, participants with advanced/metastatic cancer (including lymphoma)~     will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in~     different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.~   "
146066|NCT01655212|"~     The objective of the trial is to investigate whether early treatment with oral valganciclovir~     of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can~     prevent progression of hearing loss.~   "
146067|NCT01655199|"~     During the previous phases of the project (Phase I and II), two new field tests have been~     designed and validated for an integration in a primary care setting in Chronic Obstructive~     Pulmonary Disease (COPD). These new field tests are 3-min paced-walk test (3MPWT) and 3-min~     paced step test (3MPST). If the validity and sensitivity of the TM3 could be highlighted,~     particularly by the reduction of dyspnea level following bronchodilatation, Phase II~     highlight that the 3MPST does not allow to detect this decrease of dyspnea after~     bronchodilatation. The use of too high step rates could explain these results through a~     hypothesis relative to neuromechanical coupling of dyspnea. The main objective of this trial~     is to follow the investigations on the sensitivity of 3MPST to detect the effects of~     pharmacological intervention on the exertional dyspnea in COPD patient. The hypothesis of~     this work is that the use of lower step rates cadences could allow to detect an improvement~     of exertional dyspnea following treatment-induced bronchodilatation, contrary to higher step~     rates.~   "
146068|NCT01655186|"~     This multicenter, randomized, double-blind, placebo-controlled Phase 2 safety study will~     assess the effect of bardoxolone methyl relative to placebo on body weight and fat mass in~     approximately 60 patients with stage 4 Chronic Kidney Disease (CKD) and Type 2 Diabetes~     Mellitus (T2DM).~   "
146072|NCT01655134|"~     The telemonitoring systems for congestive HF did not yet prove their efficacy despite initial~     encouraging results. Decongestion is one of the main objectives in Congestive HF, but an~     appropriate titration of diuretics is warranted, since long-term use of diuretics was~     consistently found associated with adverse outcomes. The investigators showed (ROSSIGNOL et~     al., JACC 2011, Circulation 2012) that the aldosterone antagonist eplerenone has diuretic~     effects, as assessed by an estimated plasma volume depletion, in addition to~     potassium-sparing properties, independently from renal function variations. These three~     parameters were independently associated with patient outcomes and may therefore be potential~     monitoring/and therapeutic targets in patients with congestive HF.~      Main objective :~      To assess the variations of estimated plasma volume, serum potassium and estimated glomerular~     filtration rate after an hospitalization for decompensated HF, by using a home-based finger~     capillary punction for 5 consecutive days per week during the two months postdischarge, using~     an approved dedicated device (ABOTT iSTAT).~      Secondary objectives :~        1. to assess the correlations between plasma volume, serum potassium and estimated~          glomerular filtration rate variations (as measured by Istat, and by a weekly venous~          punction) and body weight, home blood pressure measurement, dyspnea self assessment~          variations.~        2. bio banking (serum, plasma, urine) for further biomarker studies, one a weekly basis~   "
146073|NCT01655121|"~     Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune~     response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and~     liver failure.~      There are few studies on dietary management in hepatitis and most of theme have focused on~     micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of~     other diseases associated, but few recommendations have been made regarding a complete~     dietary approach. Fiber has been proven to increase the excretion of nitrogen products and~     consequently reduce its blood levels and an adequate protein intake (1.2g/kg) has shown to~     decrease endogenous catabolism in cirrhotics patients.~      The implementation of a high protein high fiber nutrition plan and improves nutritional~     status of patients with autoimmune cirrhosis.~   "
146074|NCT01655108|"~     This study aims to investigate the effectiveness and safety of mesotherapy for the treatment~     of female pattern alopecia.~        -  Sixty female subjects between 18 and 65 years diagnosed with female pattern hair loss~          will undergo mesotherapy sessions weekly for ten weeks.~        -  One group will receive 0.5%/2ml minoxidil application and a control group will receive~          application of placebo (saline 0.9%).~        -  Biopsy of the scalp, trichogram and trichoscopy (Fotofinder) will be performed before~          and 08 weeks after treatment as a method objective evaluation of the response~   "
146075|NCT01655095|"~     Colon capsule endoscopy is a technology that has been developed as a noninvasive method of~     examining the large bowel. The biggest limitation to its use has been finding a bowel~     preparation that will both clean the colon adequately for good visualization of the mucosa~     and also help propel the capsule through the colon. Most studies have been conducted in~     Europe using bowel preparation medications that are not approved for use in North America.~      The purpose of this study is to compare a combination of polyethylene glycol (PEG) and~     prucalopride to Picosalax and prucalopride to determine which regime will give a better colon~     cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are used~     routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved for~     use in Canada which improves intestinal motility and should help with colon capsule transit.~      Patients who are being referred for colonoscopy will be enrolled in the study and randomized~     to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation~     with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard bowel~     preparation, patients randomized to the Picosalax group will take dulcolax three nights~     before the test and then again two nights before the test. The evening before the test~     patients will take either PEG 2L or one sachet of Picosalax. The following morning they will~     take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They will~     then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours they~     will return to the endoscopy unit where they will undergo a colonoscopy, which is the~     standard of care for examination of the colon.~      The images from the colon capsule will be reviewed and the quality of bowel preparation will~     be graded using a previously validated scale. It is hypothesized that the Picosalax and~     prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as~     there will be less turbid fluid in the colon and allow for a better view of the mucosa. Polyp~     detection and abnormalities of the mucosa detected with the colon capsule will also be~     compared to polyps and abnormalities detected at the time of colonoscopy.~   "
146076|NCT01655082|"~     The purpose of this study is to evaluate the safety profile of a repeated application of a~     new transdermal patch compared to a reference product during 3 weeks, in a large population.~   "
146077|NCT01655069|"~     This was a 40-week study to investigate how safe and effective solifenacin solution was in~     treating children or adolescents with symptoms of overactive bladder (OAB), who completed~     study 905-CL-076 (NCT01565707).~   "
146078|NCT01655056|"~     The study aims to investigate the effect of YM150 and to compare gender and ethnic~     differences in healthy Caucasian and Japanese male and female subjects.~   "
146079|NCT01655043|"~     Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the~     U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery~     disease that is considered most accurate is coronary angiography however it involves risk and~     radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi~     qualitative analysis of the myocardial perfusion images.~      In this proposal the investigators will develop a means to calculate Coronary Flow Reserve~     (CFR) using the MRI. the investigators approach has the potential to reduce mortality from~     myocardial infarction by effecting a change in the patient management paradigm. Absolute~     quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with~     more accuracy than the semi-quantitative or qualitative analysis of perfusion images.~     Measurement of Coronary Flow Reserve is important for the following reasons: decrease of~     coronary flow reserve has been identified as a first effect of CAD; it provides an objective~     measure of treatment efficacy.~      The purpose of this study is to compare images from nuclear stress test and/or coronary~     angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary~     artery disease calculating myocardial blood flow using a novel MRI technique combined to an~     extracellular Gadolinium-based contrast agent and stressor agent~   "
146080|NCT01655030|"~     The purpose of this study is to determine whether creatine monohydrate is effective as an~     adjuvant treatment for bipolar depression.~   "
146081|NCT01655017|"~     Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis~     amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on adipose~     biopsies appears to to predict weight loss response after a bariatric surgery. Non invasive~     tools to measure fibrosis needs to be validated. The investigators primary aim is to validate~     a new device able to measure adipose tissue stiffness.~      Thus the investigators plan to compare the stiffness results obtained with the device to the~     quantification of fibrosis using immuno-chemistry in massively obese patient's candidates to~     a bariatric surgery.~   "
146082|NCT01655004|"~     Aromatase inhibitors have led to significant improvements in clinical outcomes for women with~     postmenopausal hormone receptor-positive advanced breast cancer. However, there is a notable~     absence of phase III comparisons among the three agents and therefore no clear indication of~     the superiority of one AI over the others. Furthermore, there remains a distinct lack of~     predictive biomarkers of AI efficacy and toxicity to inform clinical decisions. The metabolic~     pathways of exemestane have recently been delineated and UGT2B17 is the most active hepatic~     gluconoryltransferase responsible for the glucuronidation of the crucial active exemestane~     metabolite, 17-dihydroxyexemestane. The UGT2B17*2/*2 deletion genotype is associated with~     markedly reduced glucuronidation of 17-dihydroxyexemestane in vitro and is found more~     commonly in Asians than Caucasians (60-70% vs less than 10%). Our research group recently~     demonstrated significant reduction in glucuronidation of vorinostat, a UGT2B17 substrate,~     with a trend towards improved clinical benefit rate and progression-free survival in Asian~     breast cancer patients who were UGT2B17*2 homozygotes treated with this compound. In-vivo~     studies correlating UGT2B17*2 genotype with exemestane pharmacokinetics and pharmacodynamics~     are lacking. We hypothesize that individuals with UGT2B17*2/*2 genotype have reduced~     glucuronidation of 17-dihydroxyexemestane and therefore have increased exposure to the active~     drug, resulting in improved treatment efficacy. We propose a study of exemestane in hormone~     receptor positive post-menopausal advanced breast cancer patients with prospective~     correlation of treatment outcome by UGT2B17 genotype. The primary endpoint is the correlation~     of genotype (UGT2B17*2/*2 vs those with at least one wild-type variant) with clinical benefit~     rate, and secondary endpoints include its association with exemestane pharmacokinetics,~     progression-free survival, overall survival and musculoskeletal toxicities.~   "
146083|NCT01654991|"~     This study randomizes St. Louis men to home-based STD screening or clinic-based STD~     screening. Home-based screening will be completed through the mail and clinic-based screening~     in a local clinical setting. We hypothesize that men randomized to home-based screening will~     be more likely to complete screening.~   "
146084|NCT01654965|"~     This phase I trial studies the side effects and best dose of tivantinib and topotecan~     hydrochloride in treating patients with advanced or metastatic solid tumors. Tivantinib and~     topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
146085|NCT01654939|"~     For HIV-infected patients who have access to treatment, liver diseases are a major cause of~     morbidity and mortality. Hepatitis C is the most frequently encountered liver condition in~     this population. Both diseases allow a higher level of poisonous substances (toxins) normally~     produced by the bacteria present in the gut to enter the bloodstream. This leads to a chronic~     inflammatory state, which results in faster development of liver scars (fibrosis) and~     ultimately, end stage disease (cirrhosis). To prevent this from happening, the use of~     antibiotics has been attempted to reduce the quantity of gut flora in the hopes of lowering~     the amount of toxins produced. These trials have shown promising results, but the antibiotics~     studied had major side effects and were not designed for continuous use. Rifaximin is a non~     absorbable antibiotic with very few side effects. It is already used for long periods of time~     in cirrhotic patients to treat the effects of cirrhosis on the brain (encephalopathy). This~     project will try to determine if rifaximin, by reducing the level of toxins produced by the~     bacteria in the gut, can improve the evolution of liver fibrosis in HIV-infected patients~     with hepatitis C. In this pilot study, ten patients with HIV and HCV infection will be~     followed for one year. In addition, 10 patients with HCV mono infection will also be~     followed. Both populations will be included if they are starting on rifaximin, for its~     currently approved FDA indication (hepatic encephalopathy).~   "
146086|NCT01654926|"~     Ultrafiltration (UF) technology is unique for its ability to extract fluid as an isotonic~     solution, therefore not causing substantial changes in NaCl concentrations, and the use of~     peripheral veins makes it feasible to use in out of hospital medical centers, for non~     compensated Heart Failure (HF) with a low response to diuretics. The use of UF in the United~     States and Europe in out of hospital HF centers is accepted as daily practice. Therefore the~     hypothesis of this study is that it is feasible for a professional team to effectively use~     the UF for short courses on non compensated HF patients with low or no response to Diuretics,~     in a dedicated out of hospital HF center.~   "
146087|NCT01654913|"~     This study examines the effect of oxygen supplementation on the non-invasive measurement of~     hemoglobin.~   "
146088|NCT01654900|"~     The purposes of the investigators study is to examine the overall survival and quality of~     life in elderly patients (> 75 years) undergoing open heart surgery at Hadassah medical~     center between 2008-2011. All alive patients will be phone interviewed using the 36-item~     short form health survey. Results will be compared to similar health survey results~     (36-SF)obtained from a group of Israeli adults who had no open heart surgery (controlled~     group). The investigators hypothesize that elderly patients achieve improvement in quality of~     life after open heart surgery with acceptable operative morbidity and mortality.~   "
146089|NCT01654887|"~     The primary objective of this study is to determine if lung ultrasound (LUS) can replace~     chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, we are~     looking for an overall reduction of CXR when LUS is used first. Our null hypothesis is that~     LUS cannot replace CXR for diagnosing pneumonia. Our alternate hypothesis is that LUS can~     replace CXR for diagnosing pneumonia. Our secondary objectives include: (1) a comparison of~     unscheduled healthcare visits after the index Emergency Department (ED) visit between those~     subjects who undergo CXR first and those who undergo LUS first, (2) an evaluation of the rate~     of antibiotic use between the two groups, (3) a comparison of the admission rates, and (4) a~     comparison of the length of stay in the Emergency Department between the two groups.~   "
146090|NCT01654874|"~     This trial is a single-blind, cross-over design. Up to three patients with confirmed~     metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses~     of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation~     B). Whole-body planar scintigraphic images will be acquired at various time points on the day~     of study drug administration. A pelvic SPECT/CT image will be acquired on the day of study~     drug administration. Blood will be collected for pharmacokinetic measurements following study~     drug administration. Each participant will receive an initial study drug administration~     (preparation A) and a second study drug administration (preparation B) approximately 7 to 21~     days later. A final follow-up visit will occur approximately 2 - 3 weeks after the second~     study drug administration.~   "
146100|NCT01654718|"~     This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg~     delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is~     equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy~     Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of~     Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of Wyeth~     Laboratories, USA in healthy, adult, human, male subjects under fed conditions.~   "
146091|NCT01654861|"~     -  The combination of gemcitabine and HDIVC is safe and may favorably change the clinical~          course for an individual patient.~        -  The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in~          preclinical models, where HDIVC creates a pro-oxidative effect that adds to the~          anti-tumor effect of gemcitabine.~        -  The combination of gemcitabine and HDIVC may improve Progression Free Survival (PFS).~        -  The dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg~          infusion may create sustained elevation in Vitamin C plasma levels for increased~          cytotoxic effect.~        -  The addition of HDIVC & oral supplementation of Vitamin C to standard treatment with~          gemcitabine may improve quality of life for patients with comparison to prior to~          treatment start of this protocol.~        -  CA 19-9 and inflammatory markers may show trends for patients in this trial.~   "
146092|NCT01654848|"~     In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT)~     Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological~     findings in thrombocytes and anti-body patterns is going to be investigated.~   "
146093|NCT01654835|"~     The investigators thus propose to use an innovative randomized effectiveness trial design to~     test the theory that early automatic identification of a ¡ Low Systolic Blood Pressure¡±~     clinical condition and decision-support alerts will prompt earlier hemodynamic support and a~     consequently reduce the duration of such conditions. Specifically, the investigators will~     test the hypothesis that providing DSS alerts in regards to hypotension reduces the duration~     of hypotensive episodes. The core of the investigators study will be an existing electronic~     anesthesia record and smart-alarm decision-support system. All patients undergoing surgery at~     Hillcrest will be randomly assigned to routine care or to DSS support. In patients assigned~     to DSS support, a systolic blood pressure less than 80 mmHg will generate a warning within~     three minutes after detection. Clinicians will be free to act on the alert, ignore the alert,~     or to consider the provided information without acting on it. The randomization, complete~     anesthesia record, detailed record of hypotensive events, alerts provided, clinician~     responses, and SAP response, will be captured by the investigators electronic record-keeping~     system. The investigators primary outcome will be the duration of time the patient has a~     systolic blood pressure less than 80 mmHg. Secondary outcome will be duration of~     hospitalization. The investigators will assess the effect of the alert on the primary outcome~     of time to SBP returning to above 80 mmHg using survival analysis, with time to event~     censored (and considered a non-event) at either the end of surgery or end of monitoring if~     patient did not return to above 80 mmHg.~   "
146094|NCT01654822|"~     This study aims to prove that, by a one-time topical spray on the cervix, AV2-DM is an~     effective antiviral in reducing on short term (3 months) the human papillomavirus (HPV)~     infection.~        -  Primary endpoint: significant drop in viral load AV2-DM versus placebo~        -  Secondary endpoint:the number of patients with adverse events~   "
146095|NCT01654809|"~     The purpose of this study is to observe the adverse reaction ratio and hemagglutination~     inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split~     influenza virus vaccine in different population.~   "
146096|NCT01654796|"~     This study is looking at the safety and efficacy of low field magnetic stimulation (LFMS) for~     treating patients with treatment resistant depression who are taking an antidepressant that~     is not working for them.~   "
146097|NCT01654783|"~     The objectives of this study are to investigate how oral 5-ASA drugs have been used in the~     condition without symptoms such as abdominal pain or diarrhea/bloody stool (remission stage),~     or in the transition from the condition with symptoms such as abdominal pain or~     diarrhea/bloody stool (active stage) to the remission stage in ulcerative colitis and to~     study how many patients will be able to maintain the remission stage during the observation~     period and how many times the patients will experience the active stage (relapse), as well as~     how symptoms will change during the observation period to discover better treatment plans.~   "
146098|NCT01654770|"~     Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with~     significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The~     mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a~     meta-analysis of 10 studies showed that VCE and DBE have an equivalent diagnosis yields in~     patients with obscure GIB (62% for VCE and 56% for DBE).2 The limitation of this~     meta-analysis study was that the included studies examined patients with occult OGIB and~     overt OGIB. Comparing with occult OGIB, patients with overt OGIB are more likely to present a~     significant lesion that causes a recurrent bleeding which subsequently increases risk of~     morbidity and mortality.3 According to emergency endoscopy concept from upper and lower GIB,~     patients with overt OGIB have been demonstrated the usefulness of urgent VCE and urgent DBE~     in a diagnosis tool with an impact on clinical management.4-7 Although previous studies~     showed promising data about the use of urgent enteroscopy, the debate about using VCE or DBE~     first in patients with massive overt OGIB is still uncertain. Thus in this study, we~     conducted the prospective study to compare urgent VCE with urgent DBE in patients with~     massive overt OGIB.~   "
146099|NCT01654731|"~     Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease that eventually leads~     to end-stage liver failure and death unless liver transplantation (LT) is performed.~     Ursodeoxycholic acid (UDCA) administered orally at the daily dose of 13-15 mg/kg is currently~     the only drug approved for the treatment of PBC. UDCA consistently improves biochemical liver~     tests, prolongs survival without LT, and delays histological progression as well as the~     occurrence of portal hypertension. However, a significant proportion (40%) of patients~     treated with UDCA shows an incomplete biochemical response and remains at high risk of death~     or LT. The development of new treatments in combination with UDCA is therefore needed.~     Several candidates exist among which is Bezafibrate. Bezafibrate belongs to the fibrates'~     pharmacological class, which has been developed 4 decades ago for the treatment of mixed~     hyperlipidaemia. Bezafibrate is cheap, widely available and well tolerated. There is now a~     substantial body of circumstantial evidence supporting that fibrates, and Bezafibrate in~     particular, are well tolerated and can improve biochemical liver tests in patients with PBC~     with incomplete response to UDCA. However, despite several positive successful pilot studies,~     there are still no phase 3 randomized placebo-controlled trials of fibrates for the treatment~     of PBC. The purpose of this protocol is therefore to conduct such a trial in a selected~     population of patients with PBC based on an incomplete biochemical response after 6 months of~     UDCA therapy.~   "
146101|NCT01654705|"~     This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg~     delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent~     to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy~     Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of~     Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of Wyeth~     Pharmaceuticals Inc., USA in healthy, adult, human, male subjects under fasting~     conditions.condition.~   "
146102|NCT01654692|"~     This study is designed to assess the safety and efficacy of a combination of ipilimumab and~     fotemustine in Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma.~   "
146103|NCT01654679|"~     The purpose of this study is to dermine whether local-water filtered infrared-A (wIRA)~     irradiation can reduce postoperative wound infection. wIRA irradiation is applied 20min~     directly preoperatively, before patients underwent abdominal surgery. The wIRA is a harmless~     light source, that has been described before. We test the impact and clinical outcome of~     patients undergoing a one-time preoperative wIRA irradiation on postoperative wound healing.~   "
146104|NCT01654666|"~     Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory~     effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the~     investigators will use clinical outcome, serum biochemical markers and brain magnetic~     resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory~     effects on patients undergoing carotid artery stenting.~   "
146105|NCT01654653|"~     The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown~     that colloid is better as compared to crystalloids. Several previous studies have~     demonstrated that Hypertonic Sodium Lactate (HSL) administration during cardiac surgery shows~     a promising effect. This study aims to compare hemodynamic effects and fluid balance of HSL~     with 6% Hydroxy Ethyl Starch (HES).~   "
146106|NCT01654640|"~     The purpose of this study is the evaluation of effect of metformin on obesity and metabolic~     disturbance in patients taking clozapine.~   "
146107|NCT01654627|"~     The purpose of this study is to examine the safety and usefulness of the Regenecure guided~     bone regeneration membrane for stimulating bone growth in patients that don't have enough~     bone for dental implant placement. The study will include 16 patients in each group, 20~     non-smokers and 12 smokers, a total of 32 patients will participate in the study.~   "
146108|NCT01654614|"~     Primary objective of this study was to evaluate the diagnostic capability of keratoconus~     match index (KMI) and keratoconus match probability (KMP) indexes in forme fruste keratoconus~     (FFK), and their association with a series of Pentacam-derived keratconus (KC) indexes. KMI~     and KMP parameters are KC-specifc indexes that are measured by Ocular Response Analyzer~     (ORA), based on the distinct ORA-derived waveform characteristics of KC eyes.~      Study participants were recruited from the Cornea Outpatient service in a consecutive if~     eligible basis. Two study groups were formed: a) FFK group (FFKG) that included patients~     diagnosed with FFK, and, b) Control group (CG) was formed by refractive surgery candidates.~      All ORA (Reichert Ophthalmic Instrument, Buffalo, NY, USA, software version: 3.01)and~     Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were~     performed by the same experienced operator in a consistent way~   "
146109|NCT01654601|"~     To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg.~   "
146110|NCT01654588|"~     Bronchial challenge tests (BCT) are being used to diagnose bronchial hyperactivity (BHR) and~     quantify its severity.In older children and adults, BCT is done using spirometry to measure~     the value of 20% fall in FEV1 as an indicator for positive reactivity.~      However, in young children and infants that cannot perform spirometry, other measurements are~     used as indicators for BHR. Traditionally, in these populations, appearance of wheezing on~     auscultation is used as the indicator for BHR. More recently, other measures like 50%~     increase in respiratory rate or 5% decreases in oxygen saturation are mentioned as possible~     options to determine positive BHR. Nevertheless, as these measurements probably measure~     different parameters they could vary in time of appearance.~      The investigators also noted that in older children who perform spirometry, the order of~     appearance of these different physiologic measures is not constant.~      Decrease in O2 saturation, appearance of wheezing and increase in respiratory rate (RR) do~     not all appear at the same time and not in the same order of events.~      Some children are noted to have a decrease in FEV1 without wheezing - those children can be~     difficult to diagnose as asthmatics in the primary care setting where asthma is being~     diagnosed on clinical grounds alone: wheezing and response to bronchodilators. Children who~     do not wheeze are difficult to diagnose and therefore, are not getting the appropriate~     treatment.~      Nevertheless, the data in current literature is very scant or not existing regarding these~     issues. Thus the investigators designed a study to prospectively try to answer the questions:~     do clinically significant differences exist in the concentration of the metacholine and / or~     adenosine at the time time of appearances of these parameters, what comes first, and if so,~     how does it affect the diagnosis and the severity assessment of HRA in different age groups?~   "
146111|NCT01654575|"~     Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently~     exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to~     decrease synovitis in many inflammatory joint diseases, particularly rheumatoid~     arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in~     decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic~     criteria of primary knee OA with knee pain, were included in this study.Patients meeting the~     eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral~     MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and~     secondary outcome measures included improvements in physical function scores.There was a~     statistically significant reduction in pain and improvement in function in the MTX group~     compared to the placebo group at 16 weeks.~   "
146112|NCT01654562|"~     Primary objective: To examine the short-term effects of of simvastatin on the vision on males~     with choroideremia, evaluated by full-field scotopic threshold testing. The investigators~     hypothesize that they will see a reversible decrease in the dark-adapted vision in~     participants taking simvastatin.~   "
146113|NCT01654549|"~     The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat~     content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)~     index, and anthropometric measurements (body mass index and waist circumference)in~     non-diabetic subjects with non-alcoholic fatty liver disease.~   "
146114|NCT01654536|"~     This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the~     nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered~     once daily to male and female subjects 12 years and older diagnosed with PAR.~   "
146115|NCT01654523|"~     The goals of the study are to further design, develop, and test an awareness enhancement and~     monitoring device, which will be used in the self-awareness training and general treatment of~     patients with compulsive hair-pulling behaviors, or trichotillomania.~   "
146117|NCT01654497|"~     The purpose of this study is to try to determine the maximum safe dose of dexanabinol that~     can be administered to people with brain cancer. Other purposes of this study are to:~        -  find out what effects (good and bad) dexanabinol has;~        -  see how much drug gets into the body by collecting blood and cerebrospinal fluid for use~          in pharmacokinetic (PK) studies;~        -  learn more about how dexanabinol might affect the growth of cancer cells;~        -  look at biomarkers (biochemical features that can be used to measure the progress of~          disease or the effects of a drug).~   "
146118|NCT01654484|"~     The purpose of this study is to investigate the safety and efficacy of up to three~     concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as~     monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in~     subjects with primary open-angle glaucoma or ocular hypertension.~   "
146119|NCT01654471|"~     The aim of the study is to validate the Korean version of Walking Impairment Questionnaire in~     patients with peripheral arterial occlusive disease.~   "
146120|NCT01654458|"~     There is a high prevalence of sexual and body image problems among women treated for~     gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly~     personal nature of these problems, women are often reluctant to speak to their doctors about~     these concerns and have few resources for support and information. The research team will~     conduct a prospective randomized controlled trail (RCT) to test the benefits of GyneGals, a~     12-week online (i.e. Internet-based) support group intervention for women who are sexually~     distressed due to gynecologic cancer and its treatment.~      The primary aim of this study is to determine whether a professionally-facilitated,~     information-rich, online support group is beneficial for women who are sexually distressed~     due to gynecologic cancer and the side effects of treatment.~   "
146121|NCT01654445|"~     This trial will enroll patients that have been diagnosed with a transient ischemic attack~     (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a~     minor stroke faces the possibility of long-term disability and even death, regardless of~     treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve or~     worsen over the hours or days immediately following a stroke. The purpose of this research~     trial is to study the effects of a clot-dissolving drug, tenecteplase (TNK-tPA), as a~     treatment for patients who arrive within twelve hours from stroke onset. This study is~     attempting to see if TNK-tPA given through a vein in the arm (intravenous) to patients is a~     safe treatment for stroke patients. Neither the safety nor the effectiveness of this~     treatment has been proven yet.~      This trial will be conducted at several site in Canada.~      Dr Michael Hill and Dr. Shelagh Coutts are the Principal Investigators of this trial,~     coordinated at the University of Calgary, Foothills Medical Centre.~   "
146122|NCT01654432|"~     General anesthesia and morphine based pain medicine analgesia has been the mainstay of~     practice in breast cancer surgery at Women's College Hospital. There is evidence to suggest~     that patients have a better recovery, with less pain and nausea and vomiting when nerve~     blocks or freezing of nerves are given in addition to a general anesthetic. Specifically for~     breast cancer surgery, evidence has suggested that the use of paravertebral blocks provide~     patients with a better quality of recovery after surgery. The aim of this study is to examine~     whether patients who receive the nerve blocks using an ultrasound machine in addition to~     general anesthesia have a better quality of recovery than patients who receive a general~     anesthetic alone. The hypothesis is that patients receiving ultrasound-guided paravertebral~     blocks (PVB) with propofol-based general anesthesia (GA) will have a better quality of~     recovery than patients receiving general anesthesia-opioid-analgesia. Quality of recovery~     will be assessed using a modification of the QoR-27, a validated instrument to assess~     postoperative recovery in an ambulatory surgical population.~   "
146123|NCT01654419|"~     THE PURPOSE OF THE STUDY IS COMPARE THE QUANTITY OF DISTAL MOVEMENT OF THE UPPER CANINE AND~     MOLAR USING CLASS II ELASTICS WITH AND WITHOUT SLIDING JIG IN A PERIOD OF 3 MONTHS~   "
146124|NCT01654406|"~     Fractional CO2 laser can improve the Cesarian scar~   "
146125|NCT01654393|"~     The purpose of the study is to help doctors in emergency departments know whether triage~     nurse initiated radiographs, in accordance to the Ottawa ankle rule, before emergency~     physician assessment will shorten emergency patients' visit. The investigators will examine~     the number of missed fractures between the two groups, the emergency physicians' willingness~     to apply OAR and triage nurses' satisfaction.~   "
146126|NCT01654380|"~     LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.~     This study is designed to understand how the body handles the investigational drug, what~     effect this investigational drug has on the body and how much should be given. This study~     will also measure how much of the investigational drug gets into the blood stream and how~     long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in~     healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus~     (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including~     screening. Screening will be performed within 30 days of the start of the study.~   "
146127|NCT01654367|"~     Select patients of primary breast cancer whose hormone receptor is positive and accepted~     postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with~     zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase~     treatment. Assess the disease-free survival; overall survival; combination of security, as~     well as the situation of bone loss.~   "
146128|NCT01654354|"~     Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide~     768.86mg) in abdominal CT~   "
146129|NCT01654341|"~     The MID-Frail STUDY project focuses on the use of interventions designed to improve~     functional status and enhance quality of life (rather than traditional treatments such as~     glucose- and blood pressure- lowering) by acting on the mechanisms involved in producing~     frailty and its progression to adverse outcomes.~   "
146130|NCT01654328|"~     The purpose of this study is to investigate if home-hydration is a non inferior alternative~     for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk~     patients.~   "
146171|NCT01653795|"~     The aim of this randomized prospective study is to compare two single-use laryngeal mask~     airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators~     hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA~     Unique.~   "
146131|NCT01654315|"~     Of the 5.7 million stroke survivors in the United States, up to 80% exhibit significant~     weakness in one arm (called hemiparesis). This devastating impairment undermines~     performance of valued activities and quality of life. Although rehabilitation is commonly~     provided, conventional affected arm rehabilitative strategies have negative evidence, or no~     evidence, supporting their use. Thus, there remains a need for evidence-based rehabilitative~     strategies for arm hemiparesis.~      Newer rehabilitative approaches emphasize repetitive, task-specific practice (RTP)~     incorporating the affected arm. However, many of these promising regimens require~     participation in intensive therapies, and most are only efficacious on the least impaired~     patients. Thus, there remains a need for an efficacious, practical RTP technique to address~     moderate affected arm hemiparesis.~      To address the above shortfalls, one of the investigators team members piloted an innovative~     brace integrating electromyography (EMG) and robotics. In his case series, 8 stroke patients~     exhibiting moderate arm impairment successfully participated in RTP, with the brace (called~     the Myomo) detecting and augmenting their movement attempts. Aided by the Myomo,~     participation in the RTP regimen reduced subjects' affected arm impairment and spasticity.~     The next logical step is to test Myomo + RTP efficacy using randomized controlled methods and~     an appropriate sample size.~   "
146132|NCT01654302|"~     Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number~     of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this~     condition. This study examines a different topical approach, utilizing a topical anesthetic~     agent, to evaluate if application of such an agent would provide relief of exercise-induced~     knee pain in people with knee OA.~   "
146133|NCT01654289|"~     The primary goal of this project is to determine whether behavioral training in mindfulness~     meditation or moderate intensity sustained exercise will lead to reductions in acute~     respiratory infection (ARI) illness, such as common cold and influenza like illness.~     Specifically, this project aims to:~        1. Determine whether an 8-week training program in mindfulness meditation, as compared to~          the control group, will lead to significant reductions in incidence, duration, and~          severity of ARI illness.~        2. Determine whether an 8-week training program in moderate intensity sustained exercise,~          as compared to the control group, will lead to reductions in incidence, duration, and~          severity of ARI illness.~        3. Assess whether any observed reductions in ARI illness are accompanied by fewer~          ARI-related health care visits and less time lost to productive work (reduced~          absenteeism).~        4. Compare the potential benefits of mindfulness meditation to those from moderate~          intensity sustained exercise.~        5. Discern potential mediating factors and causal pathways that might help explain how~          these interventions lead to improved ARI illness-related outcomes.~      The investigators' preliminary findings suggest substantial benefit of these interventions in~     terms of reduced incidence, duration and severity of ARI illness, with corresponding~     reductions in days of work lost to illness. If the proposed research confirms these findings,~     there will be major implications for public and private health-related policy and practice,~     as well as for scientific knowledge regarding health maintenance and disease prevention.~   "
146134|NCT01654276|"~     This study is being done to evaluate whether the medication, febuxostat, can improve the~     degree of insulin resistance and other features of the metabolic syndrome (high blood~     pressure, elevated insulin levels, excess body fat around the waist, and/or high cholesterol)~     by lowering uric acid levels in the blood.~   "
146135|NCT01654263|"~     The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study~     will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two~     groups of participants (55 through 74 years of age). First group vaccine naïve participants~     will be open-label to receive a single injection of 0.5 mL PCV13. Second group of participant~     previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) will be~     randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each arm (Group IIA or~     Group IIB). Blood samples will be obtained at baseline, at one month and six months~     post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are~     statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least~     some of the vaccine serotypes among participants 55 through 74 years of age previously~     vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study~   "
146136|NCT01654250|"~     The safety and efficacy of a chewable formulation of extended-release methylphenidate will be~     studied in children with ADHD~   "
146137|NCT01654237|"~     The hypothesis of this study is that there will be a variety of factors influencing the~     musculoskeletal complaints among workers of different sectors.~      Work-related musculoskeletal disorders (WMSDs) account for more than 30% of occupational~     diseases in the world. In order to organize the strategic actions that will be developed for~     the prevention of MSDs, it is essential to analyze in advance the peculiar situations of the~     different sectors of a workplace. The objectives of this study were to determine the~     prevalence of musculoskeletal complaints among workers in a medium-sized industry by~     comparing its sectors and to investigate the influence of occupational and non-occupational~     factors in the increase of complaints.~   "
146138|NCT01654224|"~     The purpose of the study is to compare the performance of two currently available influenza~     (flu) vaccines. This study will try and determine if the high dose flu vaccine provides~     protection that is the same or better than that of regular dose flu vaccine. Both the regular~     dose and the high dose flu vaccines are approved by the FDA for use in older adults.~   "
146139|NCT01654211|"~     This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous~     danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on~     the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.~   "
146168|NCT01653834|"~     This research study is being done to see if lymphocytes can be collected from patients with~     high grade gliomas before they start standard radiation and chemotherapy. (Lymphocytes are~     cells that normally circulate in the blood and are an essential part of the immune system).~     The investigators goal is to store these and give them back to the patient after radiation is~     completed. This is part of a larger effort that will attempt to preserve the immune system~     from the effects of radiation and chemotherapy.~   "
146169|NCT01653821|"~     The aim of the study is to determine safety, tolerability and feasibility of unilateral and~     bilateral carotid body excision in patients with systolic heart failure and peripheral~     chemoreceptor hypersensitivity.~   "
146140|NCT01654198|"~     When patients with psoriasis develop joint pain, it is often hard to decide whether or not~     the pain is due to psoriatic arthritis (PsA). At this time, doctors use information from the~     history and physical exam to determine the diagnosis. X-rays, magnetic resonance imaging~     (MRI) and ultrasound have been used to help with the diagnosis but all three have~     limitations. A newer imaging technique, whole body Positron Emission Tomography/Computed~     Tomography (PET/CT) uses the idea that inflammatory cells take up sugar to locate~     inflammation in the body. Because patients with PsA have inflammatory cells in their joints~     and tendons, this type of scan allows the physician to take a picture of the whole body and~     locate inflammation. The investigators have found that some patients with psoriasis (but~     without arthritis) have inflammation in joints and tendons even before the patient has~     symptoms. In this study, the investigators will explore how well PET/CT works for assessing~     inflammation in patients with PsA. This would be a very exciting tool that could be used to~     find and treat inflammation before it causes damage or pain.~   "
146141|NCT01654185|"~     The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic~     breast cancer.~   "
146142|NCT01654172|"~     Cocoa flavanols form part of the family of chemicals (also found in red wine and tea) which~     have aroused interest due to population studies suggesting that diets high in these~     substances might reduce risks of heart disease. In the laboratory, these flavanols have been~     shown to cause blood vessels to widen and blood flow to increase. As dysfunction in this~     ability of blood vessels to widen is now thought to play a central role in the complications~     of diabetes, novel ways to mitigate this are constantly being sought.~      The present study aims to use non-invasive magnetic resonance imaging (MRI) to measure foot~     and brain blood flow before and after 7 days consumption of a cocoa drink high in flavanols,~     in subjects with diabetes, with and without peripheral neuropathy.~   "
146143|NCT01654159|"~     The main objective of this research is to assess visual function and optical performance of~     CE marked, implanted intraocular lenses to understand the individual factors that affect~     their performance and how these may be improved in future designs and to evaluate measurement~     techniques.~      All outcome measures will be captured 3-6 months after surgery~   "
146144|NCT01654146|"~     The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or~     carboplatin at a lower dose every week) is more effective than standard chemotherapy~     (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian~     cancer. The investigators also want to see if weekly chemotherapy causes more or fewer~     side-effects than standard chemotherapy.~   "
146145|NCT01654133|"~     The purpose of this study is to evaluate visceral function, after endovascular repair of~     thoracoabdominal aneurysms.~   "
146146|NCT01654120|"~     The purpose of this study is to determine the effect of adding liraglutide to high dose~     insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated~     Type 2 diabetes with insulin requirements of > 100 units of insulin per day.~   "
146147|NCT01654107|"~     The investigators propose to develop a theory-based smoking cessation intervention (called~     Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling~     sessions and use of nicotine lozenge for 12 weeks. The investigators will test the~     feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and~     prolonged abstinence).~   "
146148|NCT01654094|"~     The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the~     Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in~     burn wounds resulting from thermal burn injuries.~   "
146149|NCT01654081|"~     The goal of this trial is to demonstrate the potential clinical benefit of irinotecan~     chemotherapy in patients with a specific NSCLC phenotype, ISG15-positive. The use of~     irinotecan in subjects with ISG15-positive NSCLC will be associated with an improved rate of~     clinical benefit (objective response, disease stability, and time to progression) compared to~     historical controls that were not previously selected for ISG-15 expression.~   "
146150|NCT01654068|"~     The purpose of this study is to determine if Conformal High Dose Intensity Modulated~     Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal~     column. This study involves patients who have been diagnosed with metastatic cancer to the~     thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the~     area of concern. The goal is to prove that this is not only a safe form of treatment, but~     that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer~     coming back in the area that the investigators treat which may reduce the risk of developing~     symptoms like pain in the future.~   "
146151|NCT01654055|"~     Morphine is the gold standard for treatment of severe acute pain but it has a number of~     adverse effects.~      No study has so far managed to identify the morphine-induced adverse drug reactions. The~     primary objective of this study is to determine predictive factors of morphine-induced~     adverse drug reaction when it is used in emergency departments.~   "
146152|NCT01654042|"~     More than 2 million patients in North America are treated with warfarin - a blood thinner -~     to prevent blood clots in arteries or veins. The treatment has to be monitored with a blood~     test and the dose changed accordingly every 1-4 weeks. One third of the patients have very~     stable results and hardly ever have to change the dose. The investigators wish to show that~     the level of control of the treatment with warfarin in these very stable patients is not~     worse with 12-weekly testing. A pilot study the investigators performed indicated that~     12-weekly testing would be safe but this has to be confirmed in a large study. One third of~     patients taking warfarin have not had any changes in the dose for the past 6 months or~     longer. These patients will be asked about participation in the study. They will be~     randomized to testing and dosing every 4 or 12 weeks. Each patient is in the study until it~     ends, which will be minimum 1 year and can be up to about 4 years. The study is designed to~     show that 12-weekly testing does not significantly increase the risk for major bleeding or~     blood clots. The results would be important for a large number of patients. An increase of~     the interval between blood tests from 4 to 12 weeks would reduce the burden for these~     patients on life-long treatment considerably.~   "
146170|NCT01653808|"~     The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio~     210H dialyzer between two dialysis modalities, conventional hemodialysis and on line~     hemodiafiltration.~   "
146153|NCT01654029|"~     The most frequent consequence of a stroke is a communication impairment. When patients cannot~     articulate their needs, frustration and agitation are frequent responses, often resulting in~     poor optimization of post-stroke function. Staff's lack of knowledge of communication~     strategies exacerbates the problem. A key component of patient-centred care is the ability of~     staff to communicate in such a way that allows them to understand the patient's needs.~     Members of our team developed the patient-centred communication intervention (PCCI) targeting~     registered and unregulated staff caring for complex continuing care (CCC) patients with~     communication impairments post stroke. The purpose of the study is to examine if the PCCI~     results in improved patients' quality of life and in improved staff attitudes and skills in~     caring for patients with communication impairments.~   "
146154|NCT01654016|"~     Aim of the study:~      To investigate if there is a differences in expression of inflammatory markers in venous wall~     and blood among patients treated with Detralex and those not treated with Detralex (control~     group).~   "
146155|NCT01654003|"~     This study wants to compared the safety and efficacy of GDTs using standard pressure-related~     parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in~     septic patients requiring emergency surgery.~   "
146156|NCT01653990|"~     A single-center, randomized, double-blinded, 2-way crossover, placebo-controlled study to~     assess the QTc interval after administration of single oral dose of 400mg Moxifloxacin in~     healthy Chinese subjects.~   "
146157|NCT01653977|"~     This study compares the safety and efficacy of GDTs using standard pressure-related~     parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in~     trauma patients requiring emergency surgery.~   "
146158|NCT01653964|"~     The primary objective of this work is to determine if half-dose Molecular Breast Imaging~     (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied~     can achieve image quality and diagnostic accuracy non-inferior to that of standard MBI~     performed with 8 millicurie (mCi) Tc-99m sestamibi.~   "
146159|NCT01653951|"~     The results of the pre-pilot and pilot studies will be used to determine the feasibility of a~     fully powered trial that will test the effectiveness of two different approaches to diabetes~     management in an uninsured diabetic population who receives their care from a community based~     free clinic, namely nurse-directed interdisciplinary care management compared to peer-led~     self management. Effective programs for the uninsured diabetic will benefit both the~     individual and society by preventing serious illness, decreasing mortality and disability,~     decreasing medical debt, stimulating economic growth, improving business productivity,~     reducing job lock, decreasing health disparities, improving quality of life, and reducing~     cost shifting by decreasing uncompensated care. Findings will be generalizable to uninsured~     and insured patients across a wide spectrum of chronic conditions.~   "
146160|NCT01653938|"~     This is a randomized controlled trial of a CPR video decision aid in patients with advanced~     congestive heart failure (CHF).~   "
146161|NCT01653925|"~     The purpose of this study is to determine whether marine omega-3 fatty acids and~     5-alpha-reductase inhibitor are effective in the progression of prostate cancer for low-risk~     prostate cancer patients.~   "
146162|NCT01653912|"~     -  Dose-finding study of GSK2110183 administered in combination with carboplatin and~          paclitaxel to any subject with recurrent ovarian cancer.~        -  Safety and efficacy study of GSK2110183 administered in combination with carboplatin and~          paclitaxel to subjects with platinum-resistant ovarian cancer.~   "
146163|NCT01653899|"~     This is an Investigator Initiated, Phase I/II study, where Type 1 diabetic participants will~     receive a 14 day oral treatment of the investigational caspase inhibitor drug IDN-6556~     following their first islet transplant. Two pilot studies are proposed to establish the~     optimal safety and efficacy dose of IDN-6556 (25 mg twice daily (Pilot 1) or a loading dose~     of 100 mg two hours prior to transplantation, then two 50 mg doses following transplant (Day~     0) (Pilot 2). This will be followed by 50 mg three times daily). Participants of both pilot~     studies will receive islet cell transplants under the University of Alberta's~     standard-of-care therapy.~      Secondary objectives include:~        1. To determine the proportion of subjects treated with IDN-6556 who achieve and maintain~          insulin independence after the first or subsequent islet transplant.~        2. To obtain preliminary data on the efficacy of IDN-6556 to maintain adequate~          immunological protection against both allo- and autoimmunity of islet transplant~          recipients.~   "
146164|NCT01653886|"~     A pilot study was conducted to develop the study menus that were similar in appearance,~     aroma, and taste.~   "
146165|NCT01653873|"~     After vertebroplasty, many patients will suffer from 2nd fracture in the vertebral column.~     With analyzing of the images done right after the 1st vertebroplasty, we can define the~     parameters from different imaging and they can be predictors of the future fracture.~   "
146166|NCT01653860|"~     The purpose of this study is to investigate the effectiveness of the Brøset anger management~     model in reducing violent behavior amongst clients who are violent in intimate partnerships~     and who voluntarily seek help.~      Violence in intimate partnerships constitutes a serious problem worldwide and there is reason~     to believe that cognitive behavior therapy has some effect on the reduction of violent~     behavior. However, there are currently too few randomized controlled studies to conclude~     about the effectiveness of cognitive behavior therapy for this client group.~   "
146167|NCT01653847|"~     The immune system is the body's defense against infection and other disease. After~     transplantation, the body sees the new organ as foreign and tries to destroy or reject~     it. Immunosuppressive medications help to prevent the immune system from attacking a~     transplanted organ. The primary purpose of this study is to investigate the impact of two~     maintenance immunosuppressive regimens. Subjects who enroll in this study will be randomly~     selected to have tacrolimus and everolimus (group 1) or tacrolimus and mycophenolate mofetil~     (group 2) as their immunosuppression medication.~      This study will enroll adult patients who are scheduled to receive a kidney transplant.~      The study is designed to understand the mechanisms of Everolimus in regards to kidney~     function in transplant recipients. The investigators hypothesis is that decreased exposure to~     Tacrolimus to the immune system will then translate in better renal allograft function.~   "
146172|NCT01653782|"~     This randomized controlled study will evaluate the cost effectiveness of a yoga intervention~     compared to two evidence based programs; giving advice to stay active and guided exercise~     sessions. The first active program includes a six week standardized strength training program~     where the participants are personally instructed by a trained physiotherapist. The second~     active program is a six week standardized kundalini yoga program with group sessions twice a~     week lead by an experienced yoga instructor. Both programs consist of two exercise sessions~     per week and lasts for six weeks. After six weeks the participants are instructed to continue~     practicing their program twice a week on their own. The hypothesis are that a kundalini yoga~     program as an early intervention for Low Back Pain (LBP) is more cost effective than the two~     other interventions studied.~      Participants were recruited through the occupational health services and by advertisement in~     the local press. Study subjects eligible for inclusion were informed of the study either by~     health care personnel at the occupational health care centers or by a research assistant at~     the Karolinska Institutet. Subjects were informed that if they were eligible to participate~     in the study they would be given the opportunity to participate in one of three approaches~     for treatment of neck and back pain.~   "
146173|NCT01653769|"~     Surgery on the aorta can be associated with significant blood loss. Most commonly this is due~     to bleeding at the site of aortic anastomosis. Surgical bleeding is associated with~     significant morbidity.~      One way to prevent bleeding is to use a special glue (sealant) after performing large~     connections on the aorta. The goal of this study is to compare the different methods surgeons~     use to stop/prevent bleeding.~      The study team will collect medical information about patients before, during, and after~     surgery on their aortas, including the methods used to prevent bleeding. This information may~     help doctors improve the way that they care for these patients.~   "
146174|NCT01653756|"~     The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung~     function in mild asthmatic subjects following allergen challenge.~   "
146175|NCT01653743|"~     This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the~     efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single~     5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin~     (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation.~     Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective~     is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.~   "
146176|NCT01653730|"~     Background: Portable oxygen concentrators (POCs) featuring the latest integrated oxygen~     conserving devices (OCDs) provide greater patient accessibility and mobility during~     ambulation and travel. Recent POCs are compact, lightweight, battery-operated, and require no~     refill-time, thus meeting patients' clinical and lifestyle needs. There is, however, a lack~     of research on the clinical performance of the latest POCs that could help to determine their~     ability to maintain patients' oxygen saturations ≥ 90 % during exercise.~      Aim: The purpose of this study is to compare the ability of three POCs, with maximum oxygen~     production capabilities of 950 to 3000 ml per minute, to maintain oxygen saturations ≥ 90 %~     in patients with chronic lung disease during exercise.~      Method: Six minute walk tests (6-MWTs) will be administered in order to measure oxygen~     saturations by pulse oximetry (SpO2) in up to 20 patients with a diagnosis of either Chronic~     Obstructive Pulmonary Disease (COPD), or Pulmonary Fibrosis (PF) with documented exertional~     oxygen desaturations of ≤ 85% on room air. All participants will participate in 4 different~     6-minute walk tests: the first will be a control walk performed with the participants'~     current oxygen system set at their prescribed exertional flow rate. Then, the participants~     will perform a walk test with each of the three POCs set at the units' maximum pulse dose~     setting. The order in which the participants use the POCs will be randomly assigned using a~     sequence generator.~      Hypothesis: It is hypothesized that all three POCs will provide oxygen saturations ≥ 90 %~     during exercise in patients with chronic lung disease with moderate to severe exertional~     oxygen desaturation.~   "
146177|NCT01653717|"~     The goal of this clinical research study is to find the highest tolerable dose of T cells~     that can be given in combination with standard chemotherapy to patients with CLL. The safety~     of this combination will also be studied.~      The T cells being used in this study are a type of white blood cell that will be taken from~     your blood and then genetically changed in a laboratory. The process of changing the DNA (the~     genetic material of cells) of the T cells is called a gene transfer. After the gene transfer~     is complete, the genetically changed T-cells will be put back into your body. These T cells~     may help prevent cancer cells from coming back.~   "
146178|NCT01653704|"~     The purpose of this study is to compare the effectiveness in learning crisis resource~     management (CRM) principles when being an active participant in simulation-based education~     versus being an observer participant. The investigators hypothesize that active participants~     will improve their CRM skills more than observer participants.~   "
146179|NCT01653691|"~     Pulse-dye laser therapy has been used to treat the redness, tightness and discomfort of~     hypertrophic scars resulting from burn injuries. To date the effectiveness of laser therapy~     on children's burned scars has not been measured.~   "
146180|NCT01653678|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial~     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. The VITAL Hypertension ancillary study is being conducted among participants~     in VITAL and will examine whether vitamin D or omega-3 fatty acids are related to changes in~     blood pressure and hypertension.~   "
146191|NCT01653535|"~     The primary aim of this project is to evaluate the effects of a comprehensive intervention to~     prevent severe and chronic conduct problems in a sample of children selected as high-risk~     when they first entered school. It is hypothesized that the intervention will have positive~     effects on proximal child behavior in middle school, and high school affecting long-term~     adolescent outcomes such as conduct disorder, juvenile delinquency, school dropout, substance~     use, teen pregnancy, relational competence with peers, romantic partners and parents,~     education and employment and social and community integration.~   "
146192|NCT01653522|"~     The purpose of this study is to determine the effects of triptans and doxycycline on~     neuroinflammatory markers in acute migraine.~   "
146181|NCT01653665|"~     Despite the introduction of multiple preventative measures rates of hospital acquired~     infection in the intensive care unit remain high. New approaches to tackling this problem are~     required. The neutrophil (a type of white blood cell) is the key cell fighting bacterial and~     fungal infection in the body. This research group has already shown that the majority of~     patients on intensive care have neutrophils which don't ingest germs effectively and are~     therefore less able to fight infection. These patients, whose white blood cells don't work~     properly, are much more likely to develop a second infection whilst in hospital (hospital~     acquired infection).~      Previous work done by this group has shown that by adding a drug called granulocyte~     macrophagecolony stimulating~      factor (GM-CSF) to a sample of blood from these patients in the lab, it is possible to~     restore the ability of the white blood cells to ingest bacteria and fight infection.~      This study will test whether it is possible to restore the capacity of patients' white blood~     cells to eat germs by giving them GM-CSF as an injection while they are on intensive care.~      The study will involve identifying adult patients on intensive care whose white blood cells~     don't work properly in this way. Patients taking part in the study will receive an injection,~     under the skin, of either the drug, GM-CSF, or a solution which will have no effect~     (placebo). The investigators will compare whether those patients who have received the GM-CSF~     injection have an improvement in the function of the white blood cells compared to those who~     don't.~      As well as looking at the function of the white blood cells the investigators will also study~     whether there is a difference in the rates of infection picked up in hospital between the two~     groups.~      This study is funded by the Medical Research Council.~   "
146182|NCT01653652|"~     The purpose of the current study is to evaluate the efficacy of administering a probiotic in~     adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.~   "
146183|NCT01653639|"~     This is a single dose, open-label, randomized, crossover study in subjects with severe~     Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY~     14-2222).~   "
146184|NCT01653626|"~     A matched pair cluster-randomized trial of this intervention package will be conducted in~     four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of~     the Republic of Guatemala, using the health clinic as the unit of randomization. No external~     intervention is planned for control facilities, although enhanced monitoring, surveillance~     and data collection will occur throughout the study in all facilities in the four districts.~      The package includes 3 interventions: 1) To train health care professionals in emergency~     obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ,~     multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a~     social marketing strategy that promotes institution-based delivery; and 3) To integrate the~     role of obstetric nurse and professional midwife in intervention communities to act as~     liaisons between traditional birth attendants (TBA) and public health units. A fourth,~     cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to~     strengthen information systems and monitor perinatal outcomes throughout the two years of the~     study.~   "
146185|NCT01653613|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This laboratory study is looking into genes in samples from younger patients with~     acute lymphoblastic leukemia (ALL).~   "
146186|NCT01653600|"~     The nitinol stent has proven superior primary patency than balloon angioplasty in superficial~     femoral artery lesions. Recent stent design improvements focus on decreasing stent fracture~     rates which can negatively impact patency rates by rearranging strut alignment. In the~     literature, however, prospective, randomized, controlled, clinical trial for comparison of~     stent fracture and primary patency between different nitinol stents has never been performed~     except one study; SMART versus Luminexx stent named SuperSL trial. LifeStent is similar to~     S.M.A.R.T. stent in the design consisted of the peak-to-valley connected with S-shaped bridge~     but is different in lesser bridge (4 bridge vs. 6 bridge), large cell size on stent ends, and~     larger cell size than S.M.A.R.T. On the other hand, Recent meta-analysis has shown that the~     efficaty of cilostazol in the atherosclerotic femoropopliteal lesion was proven. However,~     still specific data regarding a variety of antiplatelet regimen in implanted femoropopliteal~     lesion are limited. Upto date, in the literature, never has never been performed the clinical~     trial for optimal duration of cilostazol use in the patient undergone stent implantation for~     femoropopliteal lesion. Thus, The purpose of our study is to examine and compare Primary~     patency and stent fracture between different two-nitinol stents (S.M.A.R.T. CONTROL versus~     Lifestent) in femoropopliteal arterial lesion and to examine and compare the optimal duration~     of cilostazol use.~   "
146187|NCT01653587|"~     Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive~     strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular~     closure device would decrease the prevalence of vascular complications at puncture site,~     reaching the non-inferiority criterion when compared to the radial access.~   "
146188|NCT01653574|"~     The hypothesis of this clinical research study is to discover if the study drug Famitinib~     Malate can shrink or slow the growth of pretreated HER2-negative metastatic breast cancer.~   "
146189|NCT01653561|"~     The hypothesis of this clinical research study is to discover if the study drug apatinib can~     shrink or slow the growth of pretreated non-triple-negative metastatic breast cancer.~   "
146190|NCT01653548|"~     The aim of the present project is to develop and evaluate a novel and brief method of~     generalizing habituation (i.e., calming down after being upset) from an original learning~     context in the laboratory to other contexts inside and outside the laboratory. Specifically,~     the primary aim of this project is to evaluate whether novel habituation reminders (HRs)~     introduced following personally-relevant emotional stressors reduce acute negative emotions~     and psychological distress outside of an original learning context. Using a team of basic and~     applied scientists, over 4 years the investigators expect to screen 420 adult outpatients to~     enroll 250 study participants who have extreme difficulties with emotion regulation. These~     250 participants will be randomly assigned to one of eight experimental groups, with the~     experimental design leading them through 1 or 2 of 3 project experiments.~      Actual enrollment: 372 adult outpatients signed consent and enrolled into the study. 222~     participants were eligible and began the study. Out of the 222, 210 completed the study (as~     opposed to the desired 250).~      Experiment 1 will evaluate whether novel auditory HRs following personally-relevant emotional~     stressors differentially reduce psychological distress and negative emotions (via self-report~     and psychophysiology), compared to no HRs, within the same and different lab contexts after a~     1 week delay. Experiment 2 will evaluate whether HRs differentially reduce negative emotions,~     psychological distress, difficulties with emotion regulation, and psychiatric symptoms,~     compared to sham sounds outside the laboratory across a 1 week period, using 8x daily~     assessments of distress and emotions and automated HRs/shams when acute negative emotions are~     present. An automated server and cellular phone system will be used to assess distress and~     emotional states and to deliver HRs/shams. Experiment 3 will examine the feasibility,~     acceptability, and preliminary effect size estimates when participants self-initiate the use~     of HRs in their daily lives across a 2 week period when acute negative emotions are present.~     The specific randomization rules across the 8 groups are explained in detail in the full~     protocol .~      Risks in this study may arise from 1) the assessment interviews and questionnaires, and 2)~     discussing and hearing self-reported distressing events. Initial analyses will focus on the~     success of randomization to groups. The investigators will examine group differences on~     possible covariates (e.g., demographic variables) and those that are different across~     conditions will be used as covariates. Preliminary analyses will examine distributional~     properties of primary outcome measures and correlations among outcome measures and possible~     covariates. The investigators will set alpha at .05 for all analyses of primary hypotheses.~     To examine the influence of psychiatric symptoms (compared to the HR) on primary outcomes,~     the investigators will examine the relationship between baseline clinically relevant~     psychiatric variables (e.g., symptom severity) and changes in SUDS, emotional arousal, and~     clinical outcomes over time and if appropriate include these variables in primary analyses.~     Full data analytic plans are described in the full protocol.~   "
146195|NCT01653483|"~     This is a randomized, double-blind, placebo-controlled, repeat dose, 2-period, incomplete~     block, crossover, safety and pharmacokinetic (PK) study to evaluate 3 once-daily doses of~     umeclidinium (GSK573719; UMEC) in adolescent asthma subjects aged 12 through 17 years,) who~     are currently using asthma medications that do not contain inhaled corticosteroids (non-ICS).~     The objectives are to investigate safety and tolerability, and PK after a 7-day (+2) repeat~     once-daily dose of UMEC (15.6, 62.5, and 250 mcg) in asthmatic adolescent subjects. Safety~     endpoints will include reported adverse events, vital signs, ECGs, clinical laboratory tests,~     and rescue albuterol use. The PK endpoints will include serial PK (plasma and urine)~     concentrations and derived parameters.~      Twenty four subjects will be randomized to participate in the study for up to 7 weeks~     (including: an initial screening visit, a 7 to 14-day run-in, and 2 treatment periods each of~     7 (+2) day duration, with a washout period of 7-14 days between treatment periods). There~     will be a Follow-up Visit approximately one week after the end of the second treatment~     period. Subjects will refrain from using rescue medication for 4 hours prior to any clinic~     visits, unless for emergency.~      During each treatment period, study medication will be taken once in the morning until the~     morning of Day 7 (+2 days) when subjects will return to the clinic for study assessments and~     take the last dose of study medication. On Day 7 (+2), subjects will remain in the clinic~     overnight for serial assessments (ECG, and PK plasma and urine samples over the 24-hours).~   "
146196|NCT01653470|"~     The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in~     combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus~     Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic~     solid tumors~   "
146197|NCT01653457|"~     Fibromyalgia (FM) is a chronic rheumatic disease of high prevalence and great clinical~     impact. However, the treatment for FM has limited efficacy, with an effect size of about 0.5.~     Recent studies have found raised levels of glutamate in the insula, hippocampus and posterior~     cingulate cortex regions of the brain. This has led a number of authors to suggest the~     usefulness of glutamate blocking drugs in the treatment of FM.~      Aims: To evaluate the efficacy of memantine in the treatment of pain and other symptoms of FM~     and to assess its efficacy in reducing brain glutamate levels in patients with FM. Material~     and methods: Randomized controlled trial, of six months duration (including a dose adjustment~     period of one month). 60 patients with FM will be recruited for inclusion in the study upon~     fulfillment of selection criteria, and they will be randomized in two groups: A) Treatment~     group (n=30), will receive 20 mg of memantine o.d ; B) Control group (n=30) will receive~     placebo. The main objective is to assess the efficacy of memantine in the treatment of pain~     (pain threshold, pain perception) and other symptoms in fibromyalgia (cognitive state, health~     status, state of anxiety and depression, quality of life and perceived improvement.~     Discussion: There is a need for the development of innovative and more effective alternatives~     for the treatment of FM. This clinical trial will determine whether memantine can be~     considered as an option in the treatment of FM patients.~   "
146198|NCT01653444|"~     The purpose of this study is to evaluate the safety and exploratory efficacy of GC1119~     (recombinant human α-galactosidase A) for enzyme replacement therapy in Fabry disease~     patients.~   "
146199|NCT01653431|"~     The study will examine whether the effects of computerized brain training are enhanced when~     training is combined with mild brain stimulation in patients with mild cognitive impairment.~     We hypothesize that this combination will produce greater improvements in cognitive~     functioning than computerized brain training alone.~   "
146200|NCT01653418|"~     BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used~     conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell~     transplantation. Since these components are all effective in myeloma and bortezomib has shown~     promising results in the transplant setting, here the investigators propose a phase II study~     to investigate the combination of bortezomib and BEAM as a new conditioning regimen for~     patients who relapse or progress after the first autologous transplantation and for whom a~     second autologous transplant is considered.~   "
146201|NCT01653405|"~     Over 100,000 VHA patients receive anticoagulants (blood thinners) each year to prevent blood~     clots (including strokes). Too much anticoagulation increases the risk of serious or even~     fatal bleeding, and too little anticoagulation fails to protect the patient against blood~     clots. VHA anticoagulation clinics vary widely on how much time their patients spend in the~     therapeutic range, the range within which they are protected from clots but not at excessive~     risk of bleeding. Anticoagulation clinics can improve anticoagulation control by following~     several relatively simple procedures, including following-up promptly when patients are out~     of range and focusing on educating and supporting patients with poor control. In this study,~     the investigators will promote these practices at the anticoagulation clinics of the New~     England VA region, with a goal of improving anticoagulation control.~   "
146202|NCT01653392|"~     The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine~     during pregnancy is independently associated with adverse maternal, pregnancy, or infant~     health outcomes.~   "
146203|NCT01653379|"~     This is an open-label, dose-ranging study of the vitamin D analog DP001 in patients with~     end-stage renal disease (ESRD). The primary goals of this 4-week Phase 2A study are to~     identify an appropriate starting dose of DP001 to be used in subsequent studies in this~     population and for evaluation of pharmacokinetics of DP001 in ESRD patients.~   "
146217|NCT01653197|"~     The mailer will encourage those who are due for mammograms, colonoscopies, blood pressure or~     cholesterol tests to receive the appropriate test. This particular mailer will only be sent~     to Evive clients in need to the test in question. The research will examine differences in~     follow-through on this recommendation among the targeted population over the 3-12 month~     period following the mailing as a function of experimental condition.~   "
146218|NCT01653184|"~     The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with~     age-related macular degeneration.~   "
146219|NCT01653171|"~     The purpose of this study is to determine whether premedication with Simethicone or~     Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy~     compared with use of water or no preparation.~   "
146204|NCT01653366|"~     This study is a randomized prospective clinical trial of women with metastatic breast cancer.~     The purpose of the study is to test if an intervention of regular physical activity review~     and physical activity goal setting will allow the subjects to achieve a moderate increase in~     physical activity of 6,000 steps per week. The physical activity review will consist of~     weekly telephone call to inquire about symptoms and to set physical activity goals. The study~     will also look to see if the goal setting intervention will affect the time to progression,~     change in BMI, and quality of life. Quality of life will be measured by answers to~     questionnaires provided to subjects at regular intervals during the course of the study.~     Finally, the study will examine the impact of physical activity on expression of tumor~     molecular molecules, insulin levels, and estradiol levels.~      Through an intervention of regular physical activity review and goal setting, the~     investigators hypothesize that a moderate increase in level of physical activity of 6000~     steps per week or more can be obtained by patients with metastatic breast cancer who receive~     a goal setting intervention. The investigators propose that those who are able to achieve and~     maintain greater than or equal to 22500 steps per week will demonstrate biologic and~     molecular differences compared to those who are not able to achieve that level of physical~     activity. The investigators expect that people who are more active will have longer to~     progression.~   "
146205|NCT01653353|"~     Residents of nursing homes are endangered by malnutrition and vitamin D deficiency. Our study~     checks compliance with Swiss federal recommendations on vitamin D and calcium supplementation~     among residents of a Swiss nursing home. A peer physician-applied recommendation on~     compliance with the federal recommendations with individual evaluation of the residents will~     be sent to the physicians in care. After one year, data will be collected again.~   "
146206|NCT01653340|"~     The purpose of this study is to assess short- and long-term safety, tolerability and efficacy~     of cervical High Frequency Spinal Cord Stimulation (HF-SCS) in patients suffering from~     chronic migraine refractory to conventional medical therapy.~   "
146207|NCT01653327|"~     -  The primary objective is to determine the reduction in pain score by ketamine mouthwash~          compared to placebo in head and neck cancer patients with refractory mucositis.~        -  The secondary objectives are to describe the duration of analgesia and adverse effects~          associated with ketamine and placebo.~   "
146208|NCT01653314|"~     The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg~     (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.~   "
146209|NCT01653301|"~     -  INTERACT study: to evaluate the pathological response rate in cT3 rectal cancer~        -  LEADER study: to evaluate the impact on local control of local excision~   "
146210|NCT01653288|"~     This study will evaluate the impact of a psychosocial intervention, Coping Coach, delivered~     online to children who have experience an acute medical event.~      The core study hypotheses are that children receiving the intervention will (1) endorse fewer~     maladaptive trauma-related appraisals and (2) demonstrate more adaptive coping (more~     support-seeking, more cognitive restructuring, less avoidant coping) at a 6-week follow-up,~     and (3) demonstrate lower severity of post traumatic stress (PTS) symptoms and higher health~     related quality of life (HRQOL) at 12 week follow-up.~   "
146211|NCT01653275|"~     The investigators propose a 24 week clinical research trial (12 week observational period~     followed by 12 week MedSD intervention) with feasibility of diet adoption and markers of bone~     turnover as the primary outcomes.~   "
146212|NCT01653262|"~     Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects~     with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side~     effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis~     testing will be performed.~   "
146213|NCT01653249|"~     This study will consist of 300 women aged 18-50 years. The study will show that a new~     therapeutic human papillomavirus (HPV) vaccine designed to regress a precancerous condition~     called high-grade squamous intraepithelial neoplasia (HSIL)is safe. HPV is known to cause~     cervical, vaginal, oral, and anal cancers. This novel vaccine will consist of a synthetically~     made fragment of HPV protein called E6 and yeast extract called Candin®. Previous studies~     have revealed that immune response to E6 is important in fighting HPV. We also know that~     injecting Candin has anti-HPV effect since it has been used to treat common warts which are~     caused by different types of HPV. The current standard treatment for HSIL is loop electrical~     excision procedure (LEEP). The immune system is the part of the body that fights infection~     and cancer. This research study will also examine the immune response to the vaccine and its~     effectiveness in regressing HSIL. Volunteers would be eligible to enroll in the study if they~     have had a recent Papanicolaou (Pap) smear result indicating HSIL or Cannot rule out HSIL,~     and if they meet the inclusion/exclusion criteria. Subjects will be eligible to receive~     vaccinations if biopsy confirms HSIL. A series of four vaccinations will be given roughly 3~     weeks apart, and LEEP will be performed at the end of the study approximately 12 weeks after~     the last vaccination.~   "
146214|NCT01653236|"~     Hypothesis Combination of Boceprevir with Ribavirin in treatment-naïve patients with genotype~     4 chronic hepatitis C infection will increase the proportion of patients achieving sustained~     viral response compared to standard treatment alone.~   "
146215|NCT01653223|"~     Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It~     was also reported that statins could protect endothelial function and cardiac function during~     coronary artery bypass graft. We recent found simvastatin reduced myocardial injury during~     noncoronary artery cardiac surgery in single medical center. We further investigate that~     whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with~     cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two~     medical centers.~   "
146216|NCT01653210|"~     This overall research goal will be to develop a mobile-based module to improve glycemic~     control during the menstrual cycle in women with Type 1 diabetes mellitus (T1DM). This module~     will run on an Android Operating System (OS) and will be available as: (i) a stand-alone~     application and (ii) an important additional component to a larger system, the Diabetes~     Assistant (DiAs) - a mobile-based medical platform for diabetes applications. This proposal~     aims to build one such application or module targeting the improvement of diabetes control in~     younger women who experience glucose variation related to their menstrual cycle.~   "
146220|NCT01653158|"~     This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel~     in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment~     option.~   "
146221|NCT01653145|"~     The purpose of this trial is to examine the metabolic and behavioral effects of a positive~     energy balance induced by adding food to the usual level of activity.~      It is hypothesized that: 1) food intake will not differ significantly after 2 days of~     positive energy balance induced by a high carbohydrate vs. high fat diet when both diets are~     low in energy density, and 2) food intake will be higher after a positive energy balance~     induced by a high fat/high energy dense diet vs. a high fat/low energy dense diet.~   "
146222|NCT01653132|"~     This study is being conducted this study to determine whether injections of Xeomin®, a type~     of botulinum toxin into the glands that produce saliva (one pair just below and in front of~     the ear and the other just under the jaw line) are safe and effective to treat excessive~     saliva, or drooling in patients with Parkinson's Disease (PD)/parkinsonism.~   "
146223|NCT01653119|"~     The purpose of this study is to explore the effect of 20mg high loading dose of rosuvastatin~     on recurrent events in patients with established DM who is admitted for an ACS.~   "
146224|NCT01653106|"~     The purpose of this study is to compare the effect of short-term (2 hours/120 minutes) and~     long-term (6 hours/360 minutes) schedules of crushed ice therapy (cryotherapy). Patients that~     receive high dose melphalan for bone marrow transplantation commonly develop significant~     mouth pain and sores (oral mucositis) unless cryotherapy is utilized. The goal of this study~     is to scientifically determine (using randomization and a larger sample size) if a short-term~     schedule is as effective as the standard long-term schedule in preventing, or minimizing the~     symptoms involved with oral mucositis. The study is also trying to determine the best dose of~     melphalan and how patient's body breaks down melphalan and will obtain blood through central~     venous catheter to measure the amount of melphalan in patient's blood at specific times after~     the melphalan is infused~   "
146225|NCT01653093|"~     In standard clinical care, the prostate is imaged by magnetic resonance imaging (MRI) which~     is a procedure to take pictures of body structures by using a strong magnetic field and radio~     waves. The strength of the magnet used is expressed in the unit Tesla (T); a higher Tesla~     number means the magnet has stronger pull. Standard magnetic resonance imaging of the~     prostate uses a magnet 1.5 Tesla strong as well as a specialized endorectal coil (antenna)~     inserted into the body due to the limitations using an external body coil at this magnet~     strength. MRI using a 3 Tesla magnet has a theoretical advantage over imaging at 1.5 Tesla of~     creating a signal twice as strong that can be received by the antennas, resulting in better~     pictures. The goal of this study is to make the MRI procedure more comfortable for patients~     by using an external coil instead of an endorectal coil. With this study, researchers also~     want to help patients' health care teams, the surgeons in particular. Researchers will assess~     the impact of prostate MRI, without an endorectal coil, done at 3 Tesla and with an external~     body coil on helping doctors decide which approaches to disease therapy might be best for~     patients as well as correlate patients' study images with all other clinical imaging~   "
146226|NCT01653080|"~     This study is being done due to a new imaging method that may help others in the future to~     improve evaluation of diseases in the eye and eye socket and to help make a decision~     concerning best treatment of the disease. Previous studies suggests that dynamic contrast~     enhanced MRI is ideally suited to show small structures in the eye and eye socket as well as~     to provide information about the eye socket such as blood circulation. This research may also~     provide information about the likelihood of the tumor spreading from the eye into other~     organs as well as correlate the study images with all other clinical imaging~   "
146227|NCT01653067|"~     The STORM-trial consists of two parts. In the part I (dose escalation of Temsirolimus) the~     primary objective is to establish a maximum tolerated dose of Temsirolimus in combination~     with Rituximab and DHAP. Secondary objective is to prove ability to mobilize stem cells in~     patients scheduled to high dose therapy.~      In the part II (full target dose) the primary objective is to evaluate the ORR in patients~     with relapsed diffuse large B cell lymphoma (DLBCL). The secondary objective is to evaluate~     progression free survival (PFS), overall survival (OS) and Toxicity.~   "
146228|NCT01653054|"~     The rationale for this study is that the risk of anal dysplasia in patients with inflammatory~     bowel disease (IBD) as compared to the general population has yet to be investigated~     prospectively. There have only been a few articles examining this relationship - preliminary~     results have suggested that patients with IBD are at increased risk for abnormal anal pap~     smears. As high grade anal dysplasia is strongly associated with an increased risk of anal~     carcinoma, it is important to identify all high risk groups that might benefit from routine~     screening. This pilot study aims to determine whether patients with IBD in our Bronx~     population have an increased risk of abnormal anal Pap smears. We hypothesize that there will~     be an increased incidence of abnormal anal pap smears in patients with IBD who have been~     treated with immunosuppressants, given that chronic immunosuppression is related to increased~     HPV infection.~   "
146229|NCT01653041|"~     Recipients from living donors kidneys HLA-identical were lower risk for acute rejection,~     graft loss or death. There is no clear definition of what is ideal immunosuppressive regimen~     for this population.~      Everolimus (EVR) was associated with lower incidence of viral infections and also the lowest~     incidence of neoplasms. Furthermore, immunosuppressive regimens based everolimus allow the~     reduction or elimination of calcineurin inhibitors reducing cardiovascular risks associated~     with chronic use of these agents. Moreover, the use of EVR is associated with increased~     incidence of proteinuria, which associated mechanism has not been fully elucidated. Knowing~     that proteinuria may be the first indication of recurrence of the underlying renal disease,~     detailed information about the patient's medical history and histological analysis of the~     graft may contribute with additional knowledge in this area.~      The aim of this prospective, open, single arm study that will be performed only in the~     Hospital do Rim e Hipertensão, is investigating the outcomes of kidney transplantation in~     recipients of HLA identical living donor, receiving an everolimus-based immunosuppressive~     regimen. This will include 100 recipients of first or second kidney transplant from a living~     donor HLA identical to the Kidney and Hypertension Hospital, which will be followed by a~     period of 12 months.~   "
146230|NCT01653028|"~     This phase II trial studies how well alisertib works in treating patients with sarcoma that~     has spread to other places in the body and usually cannot be cured or controlled with~     treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
146231|NCT01653015|"~     There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit~     over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who~     are unvaccinated through herd immunity. The goal of this randomized clinical trial is to~     determine whether immunizing children in Hutterite colonies with LAIV can provide increased~     community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from~     Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary~     outcome of this study will be laboratory-confirmed influenza as detected by PCR in all~     participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include~     influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.~   "
146232|NCT01653002|"~     A DNA hypermethylation of the gene locus SHOX2 can be frequently found in lung cancer tissue.~     The purpose of this study is to determine whether the assessment of the hypermethylation~     level of SHOX2 in specimens obtained by endosonographic guided bronchoscopy makes a~     contribution to lung cancer staging.~   "
146233|NCT01652989|"~     The PILI @ Work project is a 5 year randomized control trial to adapt a weight loss program~     for the employees of Native Hawaiian-serving organizations in Hawai'i. The study has two~     specific aims:~      Specific Aim 1: To adapt and implement a weight loss and weight loss maintenance program in~     Native Hawaiian-serving organizations, working with employee representatives to determine how~     the intervention can be best implemented with employees at the worksites. Specific Aim 2:~     Among employees participating in the program, to test whether weight loss maintenance program~     in DVD format is as effective as the weight loss maintenance program in a group face to face~     format in maintaining weight loss for employees who complete weight loss program.~      The investigators hypothesize that the PILI @ Work interventions can be effectively adapted~     and implemented in a worksite settings with active participation by employees and employers.~     The investigators also hypothesize that overweight (BMI ≥ 25) and obese (BMI ≥ 30) employees~     who complete weight loss portion of the intervention, and are randomized to received the~     weight loss maintenance intervention via DVD will have similar success at maintaining weight~     loss compared to those randomized to PILI Maintenance in group meetings or settings. The~     investigators hypothesize that will will also be true for physical functioning,blood~     pressure, daily self-weighing, low to moderate fat and low calorie diets, and daily physical~     activity.~   "
146234|NCT01652976|"~     The purpose of this research study is to determine if the study drug, dasatinib, given in~     combination with 5-Fluorouracil, leucovorin and oxaliplatin (FOLFOX) will work against~     metastatic pancreatic cancer.~      Dasatinib is a Food and Drug Administration (FDA) approved drug for treating chronic~     myelogenous leukemia and acute lymphoblastic leukemia, however it is not currently approved~     for use in the treatment of pancreatic cancer.~   "
146235|NCT01652963|"~     The proposed research aims to investigate whether people with intellectual disabilities are~     able to understand and apply the theoretical principles of cognitive behaviour therapy (CBT)~     regarding the interaction between events, beliefs and emotions. Two studies are designed to~     assess and train the ability to link events, beliefs and emotions.~      Study 1 pilots computer-based tasks to assess the ability to link events, beliefs and~     emotions as well as a computer-based training programme aimed to link events and emotions.~     Task and training stimuli will be presented by line drawings to investigate whether a~     picture-based approach can reduce the impact of verbal ability on task performance. Training~     effectiveness is evaluated compared to a no-training control task.~      Study 2 compares the line drawings-based approach of Study 1 to a photographic approach to~     investigate whether the use of photographs can increase training effectiveness and further~     reduce the impact of verbal ability. It is hypothesised that the high reality value of~     photographic task stimuli, as compared to line drawings, will have positive effects on the~     assessment and training of CBT skills. It is anticipated that the findings of this research~     will improve our ability to help people with intellectual disabilities receive CBT.~   "
146236|NCT01652950|"~     Background: Physical inactivity and increased sedentary activity are major lifestyle factors~     that contribute to increasing burden of disease globally. There is evidence that the rise in~     prevalence of non-communicable diseases (NCDs) was largely responsible for growth in private~     insurance spending between 1987 and 2002 in the USA. There is renewed interest by health~     plans to implement incentivized health promotion programs, in an effort to change health~     behavior and thereby reduce health care costs related to NCDs. However, the literature on the~     role of incentives and rewards in influencing physical activity behavior, specifically, is~     relatively sparse, and the field of behavioral economics applied to health behavior is~     relatively new.~      Most studies that have been conducted typically report findings with limited, well-defined~     incentives that are offered for a short period. These studies generally have shown a~     moderation in health care costs compared to non-participants. In a cross-sectional study of~     approximately 940,000 members of a national private health insurance, Discovery Health, the~     investigators have previously demonstrated a significant and inverse relationship between~     levels of participation in fitness-related activities and medical claims associated with~     hospital admissions. More recently, in a retrospective, longitudinal analysis over 5 yrs,~     amongst more than 300,000 members, the investigators found that participation in~     fitness-related activities increased over a 5-yr period and was associated with a~     significantly lower probability of hospital admissions and inpatient claims costs.~      Aim: The current study primarily aims to prospectively compare the effectiveness of diverse~     incentives on physical activity behavior, monthly over a 12 month period following~     registration, in a cohort of newly-enrolled, adult members of the Vitality health promotion~     program.~      Study sample and random allocation to groups: Newly enrolled adult members of the Discovery~     Health medical plan and who have, themselves, prospectively registered for the Vitality~     health promotion program, will be eligible for the study, and will be invited to participate~     by Discovery Health. This recruitment, enrollment and random allocation to groups will be~     initiated via a web-based email communication, from Discovery Health, over a period of 5~     months. A final sample of 9000 adult members will be randomly allocated by Discovery Vitality~     (with replacement) to one of six study (incentive) groups (n=1500 per group) and followed~     each month for a period of 12 months.~      The intervention arms include a Control group, in which members will be offered no additional~     incentives, other than the existing incentives, to engage in all points-earning physical~     activity. There will also be a Communication Group, in which members will be offered the base~     program and, in addition, will be sent bi-weekly communications by alternating email and text~     messaging which included information on the importance of physical activity, tips on~     accumulating fitness points on the base program, a status update of points earned and~     information on benefits and rewards offered.~      The incentive arms are comprised of a Direct Payment Group, a Charity Incentive Group, a~     Lottery Pay-out Group, and a Choice Group. In each case, members will be offered the base~     program and supplementary communication described above. In addition, individuals will be~     offered the equivalent of one of four possible incentive amounts depending on the level of~     participation in fitness-related activities. Enrollment will be over a period of 5 months,~     and the intervention will take place over a period of 12 months, following registration, with~     a monthly pay-out for the incentive arms of the trial.~      The following outcomes of interest will be measured:~        -  Number of new participants (registration) in the fitness programs of Vitality~        -  Points earned, as a proxy for levels of participation, for engaging in physical activity~          (gym visits)~        -  Self-reported measures of physical activity levels, smoking and healthy eating behaviors~        -  Health care claims (de-personalized) for the 12 month period following the 12 months~          intervention~        -  Survey of attitudes to incentives and rewards in the post-study questionnaire~      Ethical considerations: Ethics approval has been obtained from the University of Cape Town/~     University of Pennsylvania Research Ethics committees. Consent will be obtained from each~     subject, who agree to participate or 'opt out' and agree that their medical claims and~     utilization data may be examined in a de-personalised manner according to their group, and~     level of participation. Further, should a member choose to drop out in the course of the~     study, or refuse to participate, there will be no adverse impact on their medical plan~     coverage and they are free to withdraw without prejudice at any time during the course of the~     study.~   "
146237|NCT01652937|"~     Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with~     Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying~     Antirheumatic Drugs (DMARDs).~   "
146238|NCT01652924|"~     The purpose of this study is to determine whether mechanical ventilation with facial mask~     during induction anesthesia in the population of 1month to 14years is associated with less~     risk of gastric insufflations as compared with manual ventilation.~   "
146239|NCT01652911|"~     This is an open-label, single arm, non-randomized safety and efficacy study, where~     participants with Type-1 diabetes will receive the Sernova Cell Pouch™ implanted in the~     subcutaneous site, two to approximately twelve weeks prior to transplantation of islets into~     the Cell Pouch™.~      The primary objective of this study is to assess the safety of the Sernova Cell Pouch™ in~     adult participants with Type-1 diabetes receiving islet transplantation for the first time.~      Secondary objectives are the following:~        1. To determine the proportion of subjects implanted with the Cell Pouch™ and transplanted~          with islets into the Cell Pouch™ who achieve and maintain insulin independence after~          islet transplantation.~        2. To obtain preliminary data on the efficacy of the Cell Pouch™ to maintain adequate~          immunological protection against both allo- and autoimmunity of islet transplant~          recipients.~        3. To determine through retrospective analysis comparative metabolic function and~          engraftment efficiency using patients undergoing standard intraportal islet~          transplantation under the current alemtuzumab standard of care protocol.~   "
146240|NCT01652898|"~     The study consists of a Pilot Phase (to assess safety and the local tolerability of highest~     AOP LDLA202 dose versus placebo) and a Main Treatment Phase (to compare PK, PD and safety and~     tolerability of AOP LDLA202, ONO LDL50 and esmolol bolus administrations by measurement of~     blood concentrations of landiolol, esmolol and their metabolites, and by monitoring ECG,~     blood pressure and adverse events).~   "
146241|NCT01652885|"~     The purpose of this study is to investigate the safety, tolerability, and systemic exposure~     of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.~   "
146242|NCT01652872|"~     A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with~     chronic kidney disease and not on dialysis will be randomized 1:1 to 1 of 2 dosing strategies~     to evaluate the proportion of subjects receiving at least one red blood cell transfusion. In~     the Hb-based titration group, darbepoetin alfa doses will be titrated to maintain hemoglobin~     (Hb) ≥ 10.0 g/dL. In the fixed dose group, subjects will receive a fixed dose of darbepoetin~     alfa. Treatment group, darbepoetin alfa doses, and protocol specified Hb concentrations will~     be blinded. Subjects will be followed for approximately 2 years from the date of~     randomization.~   "
146243|NCT01652859|"~     The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different~     liposomal amphotericin B injections after single IV infusion at the same dose in normal~     healthy subjects.~   "
146244|NCT01652833|"~     To ensure the appropriate administration of Vectibix for the treatment of mCRC with wild-type~     KRAS in real-world practice, it is important to understand the awareness of practicing~     oncologists regarding the correct indication and appropriate administration of Vectibix. It~     is also critical to monitor changes in oncologists' awareness and practice between the~     different rounds of the study.~   "
146245|NCT01652820|"~     Randomized study in 2 arms, without any masking in patients with non small cell lung cancer,~     histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA,~     according to the TNM classification of the American Joint Committee for cancer. In one arm~     will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed~     by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by~     concurrent radiotherapy with carboplatin-docetaxel~   "
146246|NCT01652807|"~     This study looks at an 8-week hatha yoga intervention for women reporting high levels of~     stress, a risk factor for various forms of psychopathology.~   "
146247|NCT01652794|"~     The purpose of this phase I study is to determine the highest dose of carboplatin and~     gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic~     cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called~     the maximum tolerated dose (MTD). To determine the MTD, patients will receive different~     amounts of carboplatin and gemcitabine.~   "
146248|NCT01652781|"~     Approved dosing schedule of azacitidine for myelodysplastic syndrome (MDS) is 75 mg/m^2/day~     subcutaneous for 7 consecutive days every 28 days, which is based on the data from standard~     chemotherapy regimen and a Phase I safety clinical trial. Since the optimal dosage of this~     drug has not been found yet, it remains as a subject of clinical study that needs to be~     examined. If initial toxicity is minimized by developing dosage/regimen that replaces the~     standard therapy, it will be possible to provide continuous treatment with increased~     convenience by patients and treating physicians as well as improvement for safety in elderly~     patients or those with serious cytopenia. In addition, it is expected to lead to a better~     response by strictly keeping a treatment schedule.~      Recent US study showed that 5-day regimen showed similar treatment results, but retrospective~     data from Spain showed lower response rate in 5-day regimen. Considering the recent~     circumstances around dosage and schedule of azacitidine in lower risk MDS, a Phase II~     clinical trial is planned in lower risk MDS patients in order to explore the efficacy in~     5-day treatment by comparing prospectively with 7-day standard regimen.~   "
146249|NCT01652768|"~     The purpose of this pilot study is to investigate the feasibility of an early palliative care~     intervention (PRESENCE: Providing Resources Education, Support, and Enabling New brain tumor~     patients to Cope Effectively) and the effect of the intervention on patient and caregiver~     distress.~   "
146250|NCT01652755|"~     To evaluate the utility of plasma cystatin C(pCysC) as a predictive and diagnostic marker of~     acute kidney injury(AKI) in patients undergone cardiopulmonary bypass surgery.~   "
146251|NCT01652742|"~     To investigate the pharmacokinetics and pharmacodynamics of BI 135585 XX following single~     dose administration.~   "
146252|NCT01652729|"~     To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once~     weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in~     subjects with type 2 diabetes mellitus.~   "
146253|NCT01652716|"~     To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once~     weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with~     type 2 diabetes mellitus.~      To examine the long-term (52 weeks of treatment) safety and effect on glucose control of~     exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.~   "
146254|NCT01652703|"~     The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every~     2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in~     low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in~     Japanese adults with hypercholesterolemia and high cardiovascular risk.~   "
146255|NCT01652690|"~     The objective of this prospective, observational study in Czech Republic and Slovakia is to~     describe per country the characteristics of women treated with denosumab in routine clinical~     practice and the clinical management of these patients during the first 2 years of treatment.~     In addition, the study aims to collect safety data in the real-life clinical practice~     settings on adverse drug reactions (ADRs) and serious ADRs.~   "
146256|NCT01652677|"~     The aim of research to study therapeutic possibilities of navigation transcranial magnetic~     stimulation in stroke rehabilitation, finding optimal protocol.~   "
146257|NCT01652664|"~     The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of~     Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution~     (0.5% or 0.25%) in pediatric glaucoma patients.~   "
146258|NCT01652651|"~     The purpose of this study is to report preliminary outcomes of executive function and~     psychopathology symptoms of a manual-based psychological intervention for adolescents~     diagnosed with learning disorders- I can succeed (ICS).~   "
146259|NCT01652638|"~     The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic~     profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by~     Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP~     Pharmaceuticals, through the determination of activity of the following markers:~        -  Anti-FXa;~        -  Anti-FIIA.~   "
146260|NCT01652625|"~     Recurrent aphthous stomatitis (RAS) is a common recurrent oral disorder with no curative~     treatment available to date. The challenge remains in patients that do develop drug~     resistance and/or secondary infection, although topical corticosteroids and antimicrobials~     are the first therapeutic choice. The aim of the study was to evaluate the efficacy and~     safety of an herbal extract of Yunnan Baiyao formulated in toothpaste as an alternative~     therapy for minor RAS.~      Yunnan Baiyao is a well-known traditional Chinese medicine, formulated in a powder or capsule~     form. It was initially and widely used in wounds for its anti-hemorrhagic hemostatic~     function, and further in gastrointestinal bleeding. Yunnan Baiyao powder has been generally~     applied on RAS among Chinese population.~      In this study, a randomized, double-blind, placebo-controlled clinical trial (from March 2010~     to March 2011) was conducted on a cohort of 227 minor RAS patients. The toothpaste containing~     Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days.~     An assessment of ulcerative size and pain was recorded on Day 0 (baseline), Day 3 and Day 5.~     Any noted adverse reactions were recorded.~   "
146261|NCT01652612|"~     Hypoxia frequently develops during one lung ventilation in the supine position.The objective~     of this article is to study the impact of preemptive alveolar recruitment and subsequent~     positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung~     ventilation in the supine position in patients undergoing thoracic surgery .~   "
146262|NCT01652599|"~     The purpose of this study is to determine the response rate and response duration with the~     combination of eltrombopag and high-dose dexamethasone~   "
146263|NCT01652586|"~     Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and~     analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are~     associated with respiratory depression and hypotension. The aim of this study was to compare~     the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect~     without serious respiratory depression, with conventional midazolam/remifentanil combination~     on sedative and analgesic levels in patients undergoing endocardial ablation.~   "
146264|NCT01652573|"~     X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United~     States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone~     call FGF23, which makes the body waste phosphate. This study is designed to determine if~     nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and~     reduce phosphate wasting in patients with XLH. In this study the investigators will:~        1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels~          of FGF23 in patients with XLH.~        2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH.~        3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D~          and calcium absorption from the intestine.~        4. Make sure that nasal calcitonin is safe and well tolerated.~   "
146265|NCT01652560|"~     - The purpose of this study is to evaluate the efficacy and safety of the application of~     bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.~   "
146266|NCT01652547|"~     This study will evaluate the preliminary safety, pharmacokinetics, and anti-tumor activity of~     pasireotide s.c. in patients with metastatic melanoma or metastatic Merkel cell carcinoma.~     The study consists of three phases: screening, intra-patient dose-escalation, and follow-up~     phases.~      In the screening phase patient will be informed of all aspects of the study and sign informed~     consent forms and then be screened for study eligibility.~      During the intra-patient dose escalation phase, 18 patients will be treated with pasireotide~     s.c. 300 μg t.i.d. for 2 weeks. If there are no unacceptable AEs, defined as drug-related~     clinically meaningful, uncontrolled grade 3 or any grade 4 toxicities, patients will be dose~     escalated to 600 μg t.i.d. for 2 more weeks, then 900 μg t.i.d. for 2 weeks and then 1200 μg~     for 2 weeks provided that there are no unacceptable AEs. Each patient will be in the dose~     escalation phase for a maximum of 8 weeks.~      At end of the intra-patient dose escalation phase, patients will be allowed to switch to 80~     mg pasireotide LAR i.m. q 28 d (or a lower dose in case of toxicity) for an additional 6~     months or until disease progression, or unacceptable AEs, or patient withdraws consent. In~     addition, all patients will keep their pasireotide s.c. t.i.d. treatment (same dose as that~     at the end of the 8-week dose escalation phase) during the first 2 weeks of the LAR follow-up~     phase, except on the day receiving the first LAR dose because of an anticipated initial burst~     of drug release.~   "
146267|NCT01652534|"~     The purpose of this study is to explore the efficacy of the drug Amantadine for the treatment~     of freezing of gait in patients with Parkinson's Disease. The investigators hypothesize that~     amantadine is useful for management of freezing of gait in subjects with Parkinson's Disease.~   "
146268|NCT01652521|"~     The effects of pleural drainage on lung mechanics are unknown. Insertion of esophageal~     balloon will allow us to measure and assess pleural pressure, and thus assess any possible~     effects of pleural fluid drainage may have on lung mechanics.~   "
146269|NCT01652508|"~     The purpose of this study is to evaluate the feasibility and potential efficacy of Acceptance~     and Commitment Therapy (ACT) in enhancing smoking cessation among attendees in primary~     healthcare settings.~   "
146270|NCT01652495|"~     The purpose of this study is to compare the efficacy and effects on the~     hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types~     of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder~     tendinopathy.~   "
146271|NCT01652482|"~     This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy~     of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU],~     and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with~     Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after~     first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be~     randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated~     time on study treatment is until disease progression or unacceptable toxicity occurs.~   "
146310|NCT01651975|"~     Dysphagia is extremely common. The importance of providing adequate nutritional support to~     persons with dysphagia is the cornerstone to exceptional care. Diet modification with~     thickening agents is an essential aspect of this nutritional support. The purpose of this~     investigation is to compare the efficacy of a starch based (Thickenup or TU) to a gel based~     thickening agent (Thickenup Advance or TUA).~   "
146272|NCT01652469|"~     Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are~     assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then~     randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel).~      It is hypothesized that the VeriStrat test results are able to predict the benefit of~     treatment with erlotinib vs docetaxel. This would suggest a significant improvement in~     progression-free survival for VSG patients when treated with Erlotinib, and no significant~     improvement in VSP patients who receive the same treatment.~   "
146273|NCT01652456|"~     This is a multicenter, interventional, randomized study for preventive and therapeutic~     strategies for patients with head and neck or Lung cancer; contribution of an addiction~     support~   "
146274|NCT01652443|"~     The current study will explore relationships and health in the OEF/OIF Veteran population.~     Specifically, this study will examine PTSD symptom severity, traumatic brain injury,~     relationship satisfaction, leisure, general health ratings, feelings of burdensomeness and~     belongingness, and suicidal ideation.~   "
146275|NCT01652430|"~     This study plans to examine if symptoms of PTSD affect how Veterans who have served in combat~     think and react to certain information, and whether or not this has an influence on suicidal~     thoughts.~   "
146276|NCT01652417|"~     Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown.~     Despite this treatment, most patients will have chronic kidney disease. From our previous~     studies, the investigators believe that high dose steroids by methylprednisolone bolus will~     improve patient outcome and renal function.~   "
146277|NCT01652404|"~     The purpose of this study is to give conclusive evidence on whether serial PCT~     (Procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic~     treatment duration in patients with sepsis in the pediatric ICU (Intensive Care Unit).~   "
146278|NCT01652391|"~     Insufficient cognitive control over emotional distracters is characteristic for major~     depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is~     associated with this deficit. In this study the investigators assess the effect of an~     enhancement of dlPFC activity in MDD patients by anodal transcranial direct current~     stimulation (tDCS) on cognitive control.~      In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators~     determine the effect of a single-session tDCS to the left dlPFC on cognitive control in MDD~     patients and healthy controls. To assess the cognitive control the investigators use a~     delayed response working memory (DWM) task with pictures of varying valence presented during~     the delay period.~   "
146279|NCT01652378|"~     In the proposed study, the investigators will assess the brain response to medication probes~     the investigators have previously studied with SPECT. The brain response to ondansetron and~     lidocaine infusions will be measured Arterial Spin Labeling and functional connectivity MRI~     (fcMRI).~   "
146280|NCT01652365|"~     The purpose of this study is to assess the feasibility and impact of introducing subsidized~     malaria rapid diagnostic tests (RDTs) into retail sector drug shops in Uganda. This is a~     randomized controlled trial at the village level, taking place in 6 districts in Eastern~     Uganda. Licensed drug shops in selected villages were trained in proper RDT storage,~     administration, interpretation and disposal and were given access to subsidized RDTs for~     sale. This study explores whether drug shop owners--when given access to training and~     subsidized RDTs--will choose to promote and sell RDTs to customers and, if so, at what volume~     and what price. The investigators also explore whether shops will safely store, administer,~     interpret and dispose of RDTs and to what extent they will use RDT results to guide treatment~     recommendations. Finally, the study explores whether making RDTs available for sale in local~     drug shops has a community level impact on diagnostic testing and appropriate treatment for~     malaria.~   "
146281|NCT01652352|"~     Researchers from the University of South Florida's Rehabilitation Engineering program are~     looking for volunteers to participate in a research study for experimental evaluation of~     wheelchair-mounted robotic arms (WMRAs).~      Participants will operate commercially available and developmental WMRAs in a physical test~     environment. The study will serve to identify desirable design features of WMRAs and input~     devices so that future production systems may further increase the quality of life of~     potential users.~      The study will also promote both the justification of prescribing WMRAs to enhance quality of~     life through the proposed standard testing method, and awareness for the emerging assistive~     robotics industry.~   "
146282|NCT01652339|"~     To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male~     subjects~        -  PK parameter evaluation~        -  Safety profile evaluation~   "
146283|NCT01652326|"~     The overarching goal of this project is to improve the clinical quality of patients with~     Benzodiazepine-resistant alcohol withdrawal syndrome.~   "
146284|NCT01652313|"~     The purpose of this study is to fulfil regulatory requirements for registration of a new~     chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease~     (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the~     efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase~     III studies.~   "
146285|NCT01652300|"~     Periodontal diseased during pregnancy are associated with many unpleasant prenatal~     consequences including preeclampsia, preterm labor, and low birth weight (LBW). Treatment of~     such diseases and observance of oral and dental hygiene may to some large extent prevent such~     consequences. Unfortunately previous studies have shown that pregnant women have very little~     knowledge of oral and dental health implications. Given the fact that pregnancy my be a~     unique opportunity to initiate correct hygienic behaviors in young women, this paper has~     focused on studying the effects of oral and dental health education during pregnancy.~      In this single blind clinical trial study,140 pregnant women receiving care from Khaje Rabi~     Regional Health Center in Mashhad city who were members of a community based multi-center~     were chosen by systematic clustering methods and randomly allocated into test and control~     groups. After intervention, two questionnaires were completed for demographic and pregnancy~     details of the participants. Knowledge, health belief and health behavior were assessed~     before intervention. The test group had two educational sessions lasting 1 hour, focused on~     oral and dental health and especially on oral and dental health during pregnancy. women in~     the control group received no education. Knowledge, health belief and health behavior were~     assessed immediately after and one month after intervention of all participants. Analysis of~     data was done using SPSS, t-test and chi-square tests.~   "
146286|NCT01652287|"~     The investigators believe a readily available drink containing a high dose of probiotics has~     the potential to improve compliance through many of these mechanisms. This product also has~     the potential to positively impact the health of children and adults around the world, as~     yogurt will likely be more appealing to both children and their parents for long term~     consumption than pharmaceutical-like preparations. In addition to the benefits associated~     with the consumption of probiotics, there is an increased health benefit from consuming~     yogurt, a nutrient dense food.~      More specifically, the rationale for this Phase I study is to determine safety of this yogurt~     drink and comply with FDA recommendations pertaining to an Investigational New Drug~     application. The investigators hypothesize that BB-12 is safe in generally healthy children~     ages 1-5 years.~   "
146287|NCT01652274|"~     It is well known that traffic accidents are one of the major reasons for death in childhood.~     Unfortunately scientific and statistical data usually comes from developed countries. In this~     study, the investigators will try to evaluate Turkish families' knowledge on Child Passenger~     Safety, observe how they carry their babies in the car and investigated the reasons behind~     the undesired behaviors.~   "
146288|NCT01652261|"~     The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and~     dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with~     treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine,~     procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG)~     positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has~     non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is~     to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.~   "
146289|NCT01652248|"~     Patients with pacemakers often have undiagnosed heart muscle weakness. When a pacemaker~     battery has run down, it is easily replaced by a short procedure. In those with heart muscle~     weakness, who use their pacemaker most of the time (rather than acting just as a back-up) the~     investigators want to find out if adding a further lead to their pacemaker system improves~     their heart's function, kidney function and exercise capacity.~   "
146290|NCT01652235|"~     The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a~     clinical trial approved by US FDA to study the safety and effectiveness of the Zenith®~     p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic~     aneurysms.~   "
146291|NCT01652222|"~     The purpose of the study is to assess the efficacy of the systematic application of the~     CONEM-BETA game in the subjective welfare of family caregivers of patients with Alzheimer's~     disease or other advanced stage dementia.~   "
146292|NCT01652209|"~     Through the injection of Hearticellgram-AMI into acute myocardial infarction patients who are~     the primary targets of the drug, long term efficacy in the improvement of the left ventricle~     ejection fraction upon the first cell treatment is to be evaluated and compared with the~     current existing treatments (contemporary drug treatment).This study will also compare the~     efficacy and safety of single dose of hearticellgram-AMI to a two dose regimen of~     hearticellgram-AMI.~   "
146293|NCT01652196|"~     This phase II trial studies how well giving aflibercept together with combination~     chemotherapy works in treating patients with previously untreated colon or rectal cancer that~     is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may stop the~     growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving aflibercept together with combination chemotherapy may kill more tumor cells~   "
146294|NCT01652183|"~     The insertion of an urinary catheter in a patient undergoing a surgical procedure, especially~     in urinary interventions, may lead to catheter-related bladder discomfort with varying~     degrees of severity during the postoperative period. Catheter-related bladder discomfort~     (CRBD) symptoms associated with indwelling urinary catheter are similar to overactive bladder~     symptoms such as discomfort in the suprapubic region, urinary urgency, frequency, burning~     sensation with or without urge incontinence. Paracetamol is a drug with proven efficiency for~     the management of mild and moderate postoperative pain. In this study, the investigators~     hypothesized to address the effect of single-dose intravenous paracetamol on postoperative~     CRBD following percutaneous nephrolithotomy surgery (PNL).~   "
146295|NCT01652170|"~     This study will consist of a brief interaction with the subject or parent or guardian to~     obtain consent, collect a blood sample, medical history, and physical examination of those~     who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well~     as processed into plasma in order to compute the APPY1 Test result, which is based on a~     combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the~     APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for~     those subjects that were discharged from the ED without an appendectomy or diagnosis of acute~     appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly~     reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing~     radiation in children, adolescents, and young adults.~   "
146296|NCT01652157|"~     This is a long-term study in cystic fibrosis patients who are participating in the Cystic~     Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder~     called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at~     their regular clinical care visits over a 10-year period and approached if they develop~     symptoms of fibrosing colonopathy for collection and use of further detailed information.~   "
146297|NCT01652144|"~     The purpose of this study is to find out what effects a new drug AT7519M has on mantle cell~     lymphoma.~   "
146309|NCT01651988|"~     OBJECTIVE: To determine the efficacy of ketamine-propofol anesthesia in a mixture 1:2 (1 mg~     of ketamine per 2 mg of propofol) for short minimally invasive surgical procedures.~      METHODS: The investigators performed a prospective study through randomization of 77 patients~     undergoing short surgical procedures in two study groups: one received a mixture of~     ketamine-propofol in a 1:1 ratio, and the other received a 1:2 mixture. Data were stored in~     an Excel spreadsheet and analyzed using the statistical program Epi-Info (TM) 3.5.3. The~     investigators performed the comparison of qualitative and quantitative variables.~      KEY WORDS: ketamine, propofol, anesthesia.~   "
146298|NCT01652131|"~     There is no objective evidence of how long intravenous solutions remain inside venous blood~     vessels after they have been administered, therefore there is no definite guideline of how to~     administer them in the preoperative setting. Besides, obese patients represent a particular~     group of subjects as they theoretically with-hold a constant inflammatory response and that~     would modify the way solutions behave intravenously, that is how long they remain inside.~      Having said this, we wish to describe the way colloid solutions behave in this group of~     patients by taking serial blood samples in 12 obese patients after a colloid infusion, to~     calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time it~     remains intravascularly.~      All this in the hope this information will help, in the near future, to establish a more~     objective way to use these solutions and avoid possible complications due to~     over-administration.~   "
146299|NCT01652118|"~     The purpose of this study is to determine of clarithromycin effect on developing of~     bronchopulmonary dysplasia in preterm babies.~   "
146300|NCT01652105|"~     Randomized clinical trial of two preoperative diets before bariatric surgery (gastric~     bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected~     for a gastric bypass procedure~   "
146301|NCT01652092|"~     This is a standard of care treatment guideline for allogeneic hematopoetic stem cell~     transplant (HSCT) in patients with primary immune deficiencies.~   "
146302|NCT01652079|"~     This research study is a Phase II clinical trial. In addition to studying safety, Phase II~     clinical trials test if the investigational drug is effective and whether the drug works in~     treating a specific cancer. Investigational means that the drug is still being studied and~     that research doctors are trying to find out more about it-such as the safest dose to use,~     the side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA (the U.S. Food and Drug Administration) has not yet~     approved CRLX101 for your type of cancer.~      Camptothecin is a chemical extracted from plants that is the basis for the standard~     FDA-approved chemotherapy drugs irinotecan and topotecan. Camptothecin works by interfering~     with the way cells divide and multiply. The investigational drug CRLX101 is a formulation of~     camptothecin and a large molecule (nanoparticle)that appears to allow more of the~     camptothecin to get into tumors and stay in tumors. The persistence of the CRLX101 in the~     tumor may increase the probability that the tumor cells will be damaged.~      CRLX101 has been well tolerated in the laboratory and in participants with different kinds of~     cancer.~      Bevacizumab (Avastin) is a VEGF inhibitor which has activity in many kinds of cancer.~     Bevacizumab has been successfully combined with many chemotherapy partners.~      It has been hypothesized that the combination of bevacizumab with CRLX101 might have unique~     clinical activity in combination in the treatment of this disease due to the simultaneous~     inhibition of distinct steps along the HIF → (CAIX) → VEGF → VEGFR2 pathway. Specifically, it~     is hypothesized that CRLX101-mediated inhibition of HIF-1α carries with it the potential to~     interrupt hypoxia and HIF-1α-associated resistance to VEGFR inhibitors. It is hoped that this~     combination will work to treat your type of cancer.~   "
146303|NCT01652066|"~     the aim of the study is to get evidence for an enhancement of immune status in subjects after~     probiotics mixture consumption ( lactobacillus gasseri PA 16/8, Bifidobacterrium longum SP~     07/3, Bifidobacterium bifidum MF 20/5) based on influenza vaccination model - compared to~     placebo.~   "
146304|NCT01652053|"~     The primary endpoints of the investigation will include assessment of the maintenance of disc~     height demonstrated by radiographic evidence based on plain radiographs and MRI and relief of~     pain as measured by Visual Analog Scale (VAS) at six months post-surgery. It is anticipated~     that outcomes with the InterCushion Disc Nucleus Prosthesis (DNP) will be comparable to or~     better than the historical published results for discectomy alone.~   "
146305|NCT01652040|"~     The goal of this proposal is to investigate the efficacy of a complimentary approach of~     evoked resistance training and testosterone replacement therapy on the changes in body~     composition and metabolic profile after SCI. The proposed method could become a recommended~     and simple intervention especially for individuals with limited access and poor tolerance to~     exercise. The rationale is based on the evidence that individuals with SCI experience decline~     in anabolic hormones which may be responsible for the deterioration in body composition and~     metabolic profiles and leads to increase obesity, type 2 diabetes mellitus, dyslipidemia and~     subsequently cardiovascular disease. The designed study will provide explanation to the~     adaptations in the energy source of the muscle cells in response to training.~   "
146306|NCT01652027|"~     Hemophilia A is a congenital bleeding disorder caused by deficiency of factor VIII (FVIII)~     and is treated by replacement therapy with FVIII concentrate. Approximately 30% of people~     with severe hemophilia A develop neutralizing antibodies, called FVIII inhibitors, which~     interfere with the function of FVIII concentrates. The reason that some, but not all, people~     with severe hemophilia A develop inhibitors is incompletely understood. Understanding~     individual and environmental risk factors is important to be able to prevent and possibly~     treat inhibitors. This study will look at individual and treatment characteristics in babies~     with severe hemophilia A who have not yet received treatment with FVIII (called Previously~     Untreated Patients, or PUPS). Subjects in the study will be asked to provide diaries of~     treatments, medications, and illnesses. Treatment will be directed by the subjects'~     physician, but all subjects will receive Advate, a third-generation recombinant FVIII~     product. Subjects will have blood drawn for laboratory tests, which include studies of the~     immune system and genetic studies of the FVIII mutation, before and 7-9 days after the first~     treatment with FVIII, and 5 days (+/-2 days) after the 5th, 10th, 20th, 30th, 40th, and 50th~     days of treatment with FVIII (exposure days). The duration of the study will be first 50~     treatments or 3 years, whichever comes first.~   "
146307|NCT01652014|"~     This study will determine the safety and applicability of experimental forms of umbilical~     cord blood (UCB) transplantation for patients with high risk hematologic malignancies who~     might benefit from a hematopoietic stem cell transplant (HSCT) but who do not have a standard~     donor option (no available HLA-matched related donor (MRD), HLA-matched unrelated donor~     (MUD)), or single UCB unit with adequate cell number and HLA-match).~   "
146308|NCT01652001|"~     The aim of our study was to evaluate the clinical efficacy of a topical sialogogue spray~     containing 1% malic acid on patients affected by xerostomia caused by drugs.~      This research took the form of a double-blind, randomized clinical trial at Faculty of~     Dentistry of University of Granada (Spain). Participants with antidepressant-induced and~     antihypertensive-induce xerostomia were divided into two groups: for the first 'intervention~     group' a topical sialogogue spray (1% malic acid) was applied, while for the second 'control~     group', a placebo spray was applied; for both groups the sprays were applied on demand during~     two weeks. The Dry Mouth Questionnaire (DMQ) was used to evaluate xerostomia levels before~     and after product/placebo application. Unstimulated and stimulated salivary flows rates,~     before and after application, were measured.~   "
146311|NCT01651962|"~     Labor pain is a major factor in making the placement of an epidural catheter difficult. The~     epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve~     this goal as fast and safely as possible it would be helpful to have a parturient who can~     tolerate and co-operate with the placement of the epidural catheter.~      Briefly stopping contractions, the cause of labor pain, could be the key to achieve this~     goal.~      This study will evaluate the safety, efficacy and duration of the drug terbutaline for this~     purpose.~   "
146312|NCT01651949|"~     This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV~     vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV~     efficacy findings in young women to young men based on the demonstration of similar~     immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody~     responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody~     responses in young women.~   "
146313|NCT01651936|"~     The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate~     (MTX) in participants with active rheumatoid arthritis (RA) and an inadequate response or~     intolerance to anti-tumor necrosis factor α (anti-TNF-α) therapy. The primary hypothesis of~     this study is that among participants with active RA, MK-8457 100 mg twice daily (BID) + MTX~     will be superior to placebo + MTX as measured by the change in Disease Activity Score 28~     C-Reactive Protein (DAS28-CRP) after 12 weeks of treatment.~   "
146314|NCT01651923|"~     The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic~     profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by~     Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP~     Pharmaceuticals, through the determination of activity of the following markers:~        -  Anti-FXa;~        -  Anti-FIIA.~   "
146315|NCT01651910|"~     The aim of the following study is to identify if cancer patients in pain report unmet~     supportive care needs that are comparable to the general cancer population or if these unmet~     needs are exacerbated depending on whether their pain is controlled, uncontrolled or if the~     patients have intermittent breakthrough pain. 312 cancer patients, who have reported to have~     either controlled, uncontrolled or breakthrough pain, will complete a series of~     questionnaires at two time points. The primary outcome is to determine the prevalence of~     self-perceived unmet supportive care needs, as identified by the Supportive Care Needs Survey~     -Short Form (SCNS-SF), in people who have pain caused by their cancer or cancer treatment.~      Hypothesis- Patients with pain caused by their cancer or cancer treatments will report unmet~     needs, which will increase if their pain is uncontrolled or if they have breakthrough pain.~      Secondary Objectives-~        1. To establish if other confounding factors -such as age, gender, marital status,~          diagnosis, educational level and treatment, are significant predictors in the reporting~          of unmet needs of people with cancer or cancer treatment related pain.~        2. To establish if there are any other symptoms, identified by the Memorial Symptom~          Assessment Scale - Short Form (MSAS-SF), that are significant predictors in the~          reporting of unmet needs of people with cancer or cancer treatment related pain.~        3. To compare the prevalence and severity of self-perceived unmet supportive care needs~          between people who experience controlled pain, uncontrolled pain and breakthrough pain.~        4. To compare the prevalence and severity of unmet supportive care needs of people whose~          pain has become controlled or uncontrolled over a period of four weeks.~        5. To identify if there are any changes in the participants' symptoms, Eastern Cooperative~          Oncology Group (ECOG) performance score or treatment that could contribute to a change~          in the reporting unmet needs between time point one and two.~        6. To establish if there are any characteristics of breakthrough pain, such as the~          frequency or severity of pain episodes, that have an association with prevalence and the~          severity of the unmet supportive care needs reported by patients with breakthrough pain~          caused by their cancer or cancer related treatments. Factors will be identified by the~          Breakthrough pain Assessment Tool (BAT).~   "
146316|NCT01651897|"~     Delirium occurs in 10% of older emergency department (ED) patients, yet it remains poorly~     understood. To date, the predominance of delirium studies have been conducted in hospitalized~     patients and therefore have limited generalizability to the ED. Understanding ED delirium's~     natural course and its effect on outcomes is not well characterized. The investigators~     hypothesize that a significant proportion of patients who are delirious in the ED will remain~     delirious in the hospital, and persistent cases of ED delirium will be significantly~     associated with higher 6-month mortality and accelerated functional decline. To test this~     hypothesis, the investigators will perform a prospective cohort study that will enroll 150~     older ED patients with delirium and a random selection of 150 older ED patients without~     delirium; both groups will comprise of admitted ED patients only. Once enrolled in the ED,~     the investigators will assess patients for 7 days during hospitalization and perform phone~     follow-up at 6-months.~   "
146317|NCT01651884|"~     The purpose of this study is to assess the changes in language processing of patients with~     chronic aphasia after receiving non-invasive brain stimulation.Previous research using~     traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has~     shown that persons with aphasia show more improvement after treatment when that treatment is~     accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver~     current to more specific locations in the brain. This new delivery method is called~     high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse~     current delivery) or HD-tDCS (more focal current delivery) will be the better approach for~     enhancing treatment outcomes. To answer this question, computerized speech-language treatment~     will be administered during the application of the different forms of brain stimulation.~   "
146318|NCT01651871|"~     The primary objective of the study was to examine the efficacy and safety of~     S-555739/cetirizine HCl compared with the individual components and placebo.~   "
146319|NCT01651858|"~     The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy~     male volunteers.~   "
146320|NCT01651845|"~     We have developed an innovative optical molecular imaging platform (called PRODIGI) based on~     high-resolution fluorescence and white-light technologies in a hand-held, real-time,~     high-resolution, non-invasive format. PRODIGI offers a non-contact means of obtaining~     instantaneous image-based measurements of diagnostically-relevant biological and molecular~     information of a wound and surrounding skin tissues for the first time and could have~     significant impact on improving conventional wound care, management, and guidance of~     intervention.~      The investigators hypothesize that real-time imaging of tissue autofluorescence signals~     emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within~     complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound~     closure), detect wound bacterial contamination and/or infection that is occult under standard~     clinical white light evaluation, and guide intervention during wound care.~   "
146321|NCT01651832|"~     Aim of the study is to increase the proportion of indicated patients with colorectal cancer~     undergoing adjuvant chemotherapy following surgical resection through an optimized symptom~     management and logistical support.~   "
146336|NCT01651637|"~     The aim of this study is to investigate the safety and tolerability of intratracheal~     administration of two different single doses of CHF 5633 in preterm neonates with RDS in~     terms of adverse events, adverse drug reactions, hematology and biochemistry values, the~     incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and~     mortality.~   "
146322|NCT01651819|"~     Urological physical therapy is described to improve urinary symptoms in patients with~     myelopathy or neurological dysfunction and to increase the quality of life. Although it was~     never tested on HTLV-1 associated overactive bladder syndrome, an disabling disease that is~     common seen in HAM/TSP patients but can also appear as an isolated form. Our hypothesis is~     that urological physical therapy can improve urinary symptoms like incontinence, urgency and~     nocturia in HTLV-1 infected population with those complains.~   "
146323|NCT01651806|"~     Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious~     than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This~     includes having a greater impact on decreasing blood loss without increasing the occurrence~     of adverse thromboembolic events in patients undergoing primary, elective total knee~     arthroplasty.~      Secondary - TA will decrease blood loss more effectively in women than in men undergoing this~     procedure.~   "
146324|NCT01651793|"~     The purpose of this study is to determine which substances in cocoa produces changes in~     mental energy. This is a double blind study. The primary outcome measures are performance on~     tasks of sustained attention (serial subtract, continuous performance test and Bakan task) at~     pre and 90, 120 and 160 minutes post intervention, energy and fatigue symptoms (profile of~     mood state), and ratings of motivation to perform cognitive tasks. The assigned interventions~     are the following:~      Active comparator 1 High flavanol, high theobromine, high caffeine, single dose~     administration in hot water vehicle Active comparator 2 High flavanol, high theobromine, low~     caffeine, single dose administration in hot water vehicle Active comparator 3 Low flavanol,~     high theobromine, high caffeine, single dose administration in hot water vehicle Active~     comparator 4 Low flavanol, low theobromine, high caffeine, single dose administration in hot~     water vehicle Inactive comparator No flavanol, no theobromine, no caffeine, single dose~     administration in hot water vehicle~   "
146325|NCT01651780|"~     The objective of this study is to assess the safety and efficacy of using bivalirudin instead~     of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The~     primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with~     heparin in TAVR procedures. Results for all participants enrolled into the randomized trial~     (BRAVO 3) are presented.~   "
146326|NCT01651767|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (what~     the body does to the medication) and antiviral activity of JNJ-47910382 when administered in~     different dosing regimens in Caucasian genotype-1 chronic HCV-infected patients.~   "
146327|NCT01651754|"~     Postcancer fatigue (PCF) is a frequently occurring, severe and invalidating problem,~     impairing quality of life. Patients with chronic fatigue syndrome (CFS) also suffer from~     severe fatigue symptoms. Although it is possible to effectively treat CFS, the nature of the~     underlying physiology remains unclear. The presence of an underlying immunological problem~     has been suggested as an explanation for PCF and CFS. The aim of this study is to compare the~     humoral and cellular immune responses upon influenza vaccination in PCF patients, CFS~     patients, non-fatigued cancer survivors, and healthy controls.~      PCF (n=20) and CFS patients (n=20) will be vaccinated against influenza. Age and gender~     matched non-fatigued cancer survivors (n=20) and healthy controls (n=20) will be included for~     comparison. Antibody responses will be measured at baseline and at day 21 by a~     hemagglutination inhibition test. T cell responses will be measured at baseline and at day 7~     by lymphocyte proliferation, activation, and cytokine secretion.~   "
146328|NCT01651741|"~     The aims of this study are to investigate the effect of seaweeds which is one of the main~     ingredients of Korean traditional food 'Kimchi' and probiotics on intestinal function of~     healthy subjects.~   "
146329|NCT01651728|"~     The objective is to assess the effect of simvastatin on immunology, inflammatory, and~     coagulation responses, and mortality in elderly with pneumonia based. The primary outcome is~     mortality event.~      The hypothesis of this study is that simvastatin therapy will reduce mortality in elderly~     with pneumonia.~   "
146330|NCT01651715|"~     The purpose of this study is to determine whether early self-treatment with homeopathic~     dilutions of oral antibodies to a key-protein of the immune system are effective and safe in~     the treatment of viral upper respiratory tract infections~   "
146331|NCT01651702|"~     Three dimensional anatomical mapping is an established method facilitating ablation of~     cardiac arrhythmias. The most commonly used systems are CARTO® System (Biosense Webster,~     Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA).~     These two systems has been compared in only a few studies. Recent technical advances resulted~     in the development of new versions of both systems. To the best of the investigators~     knowledge no studies have been performed for direct comparison of the newer versions of these~     two systems. The aim of the study to compare two systems for the use in the ablation of~     complex arrhythmias.~   "
146332|NCT01651689|"~     Hair disorders, expecialy scarring alopecia were diagnosed by scalp biopsy specimens in~     horizontal and vertical sections.(1-4) Data on hair density in Thais are lacking, although in~     Asians have more fewer hairs than whites.(5-7)Howevery, previous study from East Asian just~     had only one study and the data was more differently from West Asian and whites. Then this~     study was performed to evaluate hair density in Thais, and compared to previous study.~   "
146333|NCT01651676|"~     The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of~     life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary~     disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days)~     during the implementation of a LABD (Long-acting bronchodilator) treatment.~      The main objective is to compare the total Score of the VQ11 auto-questionnaire before and~     after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality~     of life linked to health, specifically in the COPD.~   "
146334|NCT01651663|"~     The purpose of this study is to determine whether Arbidol (Umifenovir) is effective in the~     treatment and Prophylaxis of Influenza and Common Cold~   "
146335|NCT01651650|"~     Phase IIa, single-centre, open-label, single-arm study, to evaluate the inspiration profile~     through the NEXThaler® device in adult asthmatic patients with varying degrees of disease~     control.~   "
146454|NCT01650103|"~     The purpose of this study is to verify any existing relationship between mixed oxygen~     saturation (from central venous catheter) and urinary sodium, potassium, chloride in~     determining the volemic state and renal perfusion of patients undergoing major surgical~     interventions.~   "
146337|NCT01651624|"~     RATIONALE: Computed tomographic colonography (CTC) has proven to be accurate in detecting~     colorectal neoplasms and may be a primary test in colorectal cancer screening.~      PURPOSE: This clinical trial will compare participation rate, diagnostic yield and costs of~     computed tomographic colonography, faecal occult blood test (FOBT) and colonoscopy (CO) as a~     primary screening test in a population-based programme.~   "
146338|NCT01651611|"~     The purpose of this study is to determine whether public housing residents trained in Tobacco~     Cessation and Motivational Interviewing Techniques to become Tobacco Treatment Advocates(TTA)~     will be effective in increasing the quit rate of smokers in Boston Public Housing. The~     investigators hypothesize that smokers that receive multiple TTA visits will be more likely~     to (1) use smoking cessation resources and (2) quit compared to smokers who receive a single~     visit.~   "
146339|NCT01651598|"~     In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of~     multiple dose administration of BI 144807 will be investigated in otherwise healthy,~     controlled asthmatic patients~   "
146340|NCT01651585|"~     The infection with cytomegalovirus (CMV) is the first cause of congenital neurological~     handicap of infectious origin. It is probable that the néonatale viral load is correlated~     with becoming of infected new-born babies. Among the active antiviral treatments against CMV,~     valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the~     pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to~     evaluate it in a study. Decrease the fœtal viral load could make possible to decrease~     symptomatology néonatale in a group of infected fœtuses.~   "
146341|NCT01651572|"~     The purpose of this study is to determine the incidence of post-operative residual~     curarization in our patients and to determine if Cisatracurium and Rocuronium behave~     differently from each other in terms of residual curarization.~   "
146342|NCT01651559|"~     This is a two-center study aimed to assess the efficacy of Dead Sea Minerals in alleviating~     symptoms of Psoriasis Vulgaris, in 50 patients undergoing phototherapy. A bilateral left~     right comparison will be made, after using the study product and the placebo, for 8 weeks,~     twice daily, on each of the body sides (left right). In addition to the clinical evaluations,~     skin biochemistry will be studied using non-invasive techniques. The latter will be~     correlated with the clinical results of the patients. These will serve for future development~     of diagnostic assays and personalized therapies.~   "
146343|NCT01651546|"~     The aim of the study is to create and validate a specific test named Intermittent~     Catheterization Acceptance Test (I-CAT), assessing the acceptance of clean intermittent~     self catheterization (CISC) in a neurological and no neurological population with indication~     to self catheterization.~      CISC avoids urological complications in bladder with chronic and improves quality of life.~     Despite theses challenges, the learning of CISC can face some physical, cognitive and~     psychological difficulties. Recently, we have validate a new test for predicting the physical~     and cognitive abilities to practice CISC named PP-Test. Meanwhile, psychological factors~     are not explored in this test. To our knowledge, no study has been conducted in order to~     demonstrate in a prospective trial, which kind of psychological barriers can exist. Likewise~     it would be interesting to create a new test assessing the psychological acceptance of the~     patients to CISC before learning (I-CAT). Based on the results of this self-assessment test,~     the specific nurse could then change her speech by playing down the importance of some fear~     and anxiety described by the patients. The learning of CISC would be facilitated.~   "
146344|NCT01651533|"~     Stroke is the leading cause of disability in the United States, producing motor impairments~     that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is~     particularly disabling, is the primary impairment underlying stroke-related disability, and~     the most frequent impairment treated by therapists in the United States. This study will test~     efficacy of a promising technique in reducing arm disability and increasing function, thereby~     improving outcomes and health, reducing care costs, for community dwelling patients with~     stroke-induced hemiparesis.~   "
146345|NCT01651520|"~     In this study the investigators will use PET and 11C-Flumazenil to visualize and quantify~     neuronal injury in the cortex and the deep gray matter of Multiple Sclerosis patients at an~     early stage. The investigators will follow up patients to determine the prognostic value of~     this neuronal injury.~   "
146346|NCT01651507|"~     this is a multicenter retrospective study on patients with pulmonary LCH who were~     sequentially evaluated by concomitant lung HRCT and lung function testing. The objectives of~     this study were: 1) to determine the changes over time of lung function parameters in~     patients with pulmonary LCH; 2) to compare the variations of HRCT and lung function results~     during follow-up; 3) to address the respective interest of these investigations for~     identifying the patients who eventually will experience a progression of their disease.~   "
146347|NCT01651494|"~     This study will be a double-blind, randomized, placebo-controlled study of a single dose~     (20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be~     randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the~     inpatient clinic at a minimum of the night prior to first dose. The subjects will stay in the~     inpatient clinic for the duration of dosing and one day after dosing, they will be required~     to come back for follow-up visits on study days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days), and~     90 (+/-10 days). The safety parameters will include abnormal laboratory values, adverse~     events and clinical observations.~   "
146348|NCT01651481|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10 mg)~     and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102~   "
146349|NCT01651468|"~     Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to~     assist in wound healing and bleeding arrest. It contains herbs such as Red Clover, Liquorice,~     Raspberry, Ginger and more. The present study will evaluate the formula on the coagulation~     system.~   "
146350|NCT01651455|"~     The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2~     different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.~   "
146402|NCT01650779|"~     This is an exploratory study to evaluate changes in glycosphingolipid levels and other~     (exploratory) Fabry disease parameters in male Fabry disease participants who were previously~     treated with agalsidase alfa (Replagal®) 0.2 milligram per kilogram (mg/kg) every two weeks~     (q2w) and who are being switched to agalsidase beta (Fabrazyme®) 1.0 mg/kg q2w.~   "
146351|NCT01651442|"~     Chronic insomnia is a prevalent disorder associated with increased health care costs,~     impaired functioning, and an increased risk for developing serious psychiatric disorders.~     Cognitive-behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications~     are the most widely supported approaches for insomnia management. Unfortunately, few studies~     have compared the psychological/behavioral therapies and BzRAs for insomnia treatment.~     Moreover, insomnia treatment studies have been limited by small, highly screened study~     samples, fixed-dose and fixed-agent pharmacotherapy strategies that do not represent usual~     adjustable dosing practices, relatively short follow-up intervals, and reliance on~     self-report or polysomnographic (PSG) sleep parameters as outcomes, rather than on more~     clinically relevant indicators of remission. Finally, studies have yet to test the benefits~     of treatment sequencing for those who do not respond to initial their insomnia therapy. This~     multi-site project will address these limitations. Two study sites will enroll a total of 224~     participants who meet broad criteria for a chronic insomnia disorder, and a sizeable portion~     (60%) of this sample will have insomnia occurring comorbid to a psychiatric disorder.~     Participants will be evaluated with clinical assessments and PSG, and then will be randomly~     assigned to first-stage therapy with an easy-to-administer behavioral insomnia therapy (BT)~     or zolpidem (most widely prescribed BzRA). Centrally trained therapists will administer~     therapies according to manualized, albeit flexible, treatment algorithms. Initial outcomes~     will be assessed after 6 weeks, and treatment remitters will be followed for the next 12~     months on maintenance therapy. Those not achieving remission will be offered re-randomization~     to a second, 6-week treatment involving pharmacotherapy (zolpidem or trazodone) or~     psychological therapy (BT or cognitive therapy-CT). All participants will be re-evaluated 12~     weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing~     their final treatment. Insomnia remission, defined categorically as a score < 8 on the~     Insomnia Severity Index, will serve as the primary outcome for treatment comparisons.~     Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of~     sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Our~     over-arching goal is to obtain new information that aids in the development of clinical~     guidelines for managing insomnia sufferers with and without comorbid psychiatric conditions.~   "
146352|NCT01651429|"~     Resilience is the ability to cope effectively and adapt to a wide range of stressful~     environmental challenges. Sleep loss has been shown to reduce activity in the brain regions~     responsible for resilience. The ability to resist the effects of sleep loss appears to be a~     stable, trait-like quality. This study will attempt to predict individuals' trait-resistance~     to sleep loss based on their neurobiology.~   "
146353|NCT01651416|"~     In areas of Africa where malaria is only a problem during a short rainy season, monthly~     courses of antimalarial drugs can provide very effective prevention of malaria in children.~     This approach, called intermittent preventive treatment in children (IPTc) but now known as~     Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where~     malaria is transmitted for longer each year. It is uncertain if IPTc would be effective,~     acceptable to communities or sustainable when delivered over a longer period, but this is an~     important public health question of key interest to policy makers, because in areas with a~     longer transmission season, the burden of malaria is typically higher than in highly seasonal~     areas.~      Another form of prevention that would be operationally easier for African countries to put~     into practice would be to treat malaria patients with long-lasting antimalarials, which~     protect children against further malaria episodes for several weeks. Because malaria~     disproportionately affects certain high risk children more than others, causing repeated~     attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and~     effective way to target limited resources at the individuals who most need protection. This~     may be particularly beneficial where malaria is a seasonal problem, because repeated malaria~     attacks will not only be borne by a few unfortunate children, but will also occur close~     together in time.~      The investigators propose a clinical trial to evaluate these two forms of chemoprevention in~     Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years~     of age currently have access to diagnosis and treatment of malaria via by community based~     health workers. Children enrolled in the study will receive either the standard~     community-based diagnosis and treatment, treatment with a longer-acting artemisinin~     combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria~     chemoprevention (SMC) during the peak in transmission.~   "
146354|NCT01651403|"~     This placebo-controlled study evaluates the efficacy, safety and tolerability of tenofovir~     disoproxil fumarate (TDF) in participants 2 to < 12 years old with chronic Hepatitis B~     infection. While studies have shown significant virologic response in adults and adolescents,~     the effect in children is not well established. This study will provide valuable data that~     can help establish the efficacy and safety profiles of TDF in children. The study will~     consist of 48 weeks of blinded randomized treatment, after which participants will switch to~     open-label TDF treatment for an additional 144 weeks.~   "
146355|NCT01651390|"~     To determine in a randomized controlled trial (RCT) whether percutaneous coronary~     intervention - in patients with in-stent restenosis in either bare metal stents or drug~     eluting stents - with the Pantera Lux balloon is angiographically non-inferior to~     percutaneous intervention with the Orsiro stent 6 months post-procedure.~   "
146356|NCT01651377|"~     The purposes of this study are as follows: 1. To assess the cardiovascular and subjective~     effects of cocaine during treatment with pramipexole and placebo. 2. To assess the~     reinforcing effects of cocaine, measured using choice procedures, during treatment with~     pramipexole and placebo.~   "
146357|NCT01651364|"~     The purpose of this study is to determine the effects of treatment with cabergoline, compared~     to treatment with placebo, on cocaine induced craving and subjective effects in~     cocaine-dependent human volunteers.~   "
146358|NCT01651351|"~     The purpose of this study was to generate sufficient safety and tolerability information in~     support of an increase in the infusion rate of intravenous GLASSIA in the prescribing~     information from 0.04 to 0.2 mL/kg/min.~   "
146359|NCT01651338|"~     Chronic pains can affect the life quality. This study has performed in the first time in~     Mashhad.The purpose of the present study was to examine the effect of acupuncture on the life~     quality of 150 patients who suffered from chronic pain. Some people like performing~     acupuncture because they believed it's free of risks and beneficial.~      In order to achieve this purpose, we had examined the life quality of the patients before and~     after acupuncture. This study was randomly performed on 150 patients aged between 17-75. They~     were suffering from chronic pain.~      The questionnaire is based on WHO QOL. The questionnaires were filled out once before~     acupuncture and once 12 weeks after it.~   "
146360|NCT01651325|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of dextromethorphan in healthy adult subjects.~   "
146361|NCT01651312|"~     The study aims to assess the routes and the extent of metabolism and excretion of YM178 after~     a single dose of 14C-radiolabeled YM178 administered as a drinking solution in healthy male~     volunteers.~   "
146362|NCT01651299|"~     The primary objective of the study is to evaluate the responsiveness and utility of several~     clinical outcome assessments in the setting of copperhead snakebite. The secondary objective~     is to characterize the clinical course of signs, symptoms and impairment during the recovery~     phase of copperhead snakebite.~   "
146403|NCT01650766|"~     The primary purpose of the study is to investigate the correlation between the efficacy and~     toxicity of S-1 on gastric cancers and the expression of thymidylate synthase (TS),~     dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase(OPRT).~   "
146363|NCT01651286|"~     Recently, the investigators demonstrated that nasal route ventilation is superior to the~     nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The~     investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask~     ventilation during the induction of general anesthesia by: 1) producing a better seal than~     full face mask, and 2)establishing a greater airway patency and more effectively ventilate~     than full face mask ventilation. The investigators intend to test this hypothesis on adult~     patients during the induction of general anesthesia in the absence of muscle relaxation.~   "
146364|NCT01651273|"~     The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in~     patients with high cholesterol.~   "
146365|NCT01651260|"~     Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the~     nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may~     result in accidental slippage of the tube into a mainstream bronchus or into the pharynx.~     Hollister Incorporated is assessing the functionality and performance of an endotracheal tube~     securement device.~   "
146366|NCT01651247|"~     This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® [GSK Biologicals'~     Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant)~     and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus~     Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine~     products. The samples have been collected at pre-determined time points from a subset of~     subjects who participated in selected studies [217744/085 and 213503/048] conducted in the~     United States.~   "
146367|NCT01651234|"~     The purpose of this study is to evaluate the safety, tolerability and characterize the PK, PD~     f\profile.~   "
146368|NCT01651221|"~     Increasing exposure to a single orosensory cue without ingestion of additional energy may~     promote an increased rate of habituation, more rapid satiation, and reduced intake. This~     exposure can occur via smell (olfactory) and taste (gustatory) systems.It is not clear if~     repeated exposure via the combined olfactory and gustatory systems increases the rate of~     habituation more so than repeated exposure through one of these systems. Thus, the purpose of~     this investigation is to examine the amount of salivation occurring in 12 trials of exposure~     to a food via the olfactory, gustatory, and combined olfactory and gustatory systems. The~     primary dependent variable will be the amount of salivation in the 12 trials. It is~     hypothesized that a more rapid decrease in salivation will occur across trials in the~     combined olfactory and gustatory exposure as compared to the other two conditions, indicating~     a more rapid rate of habituation.~   "
146369|NCT01651208|"~     The purpose of this study is to evaluate if the use of a phone based motivational~     interviewing among minority populations who received a coronary stent can improve adherence~     to antiplatelet agents from approximately 51% to 66% (15 percentage point increase) at 12~     months post stent placement when compared to a mailed educational DVD.~   "
146370|NCT01651195|"~     The purpose of this study is to evaluate the effect of regular consumption of probiotic~     tablets in preventing illnesses in Finnish healthy adults attending military service.~   "
146371|NCT01651182|"~     Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss~     and blood transfusion requirements in the following patient populations: multisystem trauma,~     liver transplantation, cardiac surgery and spine surgery. Patients undergoing major liver~     resection are at risk of severe perioperative blood loss and may also benefit from~     perioperative TXA administration.~      This open label, non-randomized study to evaluate the pharmacokinetic and pharmacodynamic~     properties of two well studied dosing regimens of TXA will provide guidance in determining~     the optimal TXA dosing regimen for patients undergoing major liver resection. Compelling~     evidence of the effectiveness of TXA comes from the large multicentred, multi-national~     CRASH-2 trial where TXA was administered as a 1 g bolus + 1 g infusion over 8 hours. In liver~     transplant surgery, the following dose regimen has been shown to have great effect:10 mg/kg/h~     from the start of surgery until 2 hours after reperfusion of the liver transplant.~      Although TXA is not currently approved for use in patients undergoing major liver resection,~     Health Canada has allowed the use of tranexamic acid for use in this research study.~   "
146372|NCT01651169|"~     Previous studies using transcranial magnetic stimulation (TMS) with paired pulse protocols~     have shown that a conditioning TMS pulse applied to the human motor cortex changes the~     excitability of motor pathways from the motor cortex to spinal motorneurons. These effects~     depended on the stimulus intensity of both conditioning and test pulse and also the ISI). A~     characteristical sequence of inhibition (short interval cortical inhibition [SICI],~     GABA-Aerg), facilitation (intracortical facilitation [ICF]), and inhibition again (long~     interval cortical inhibition [LICI], GABA-Berg) is thought to be physiologically involved in~     motor control. Previous studies have also shown that neuronal inhibitory motor circuits are~     also disturbed in ADHD which will be restored by using methylphenidate. In this study the~     investigators sought to investigate if methamphetamine abuse (from the same chemical class of~     medications) will alter such effects of methylphenidate.~   "
146373|NCT01651156|"~     A randomized, double-blind, multicenter, placebo-controlled, parallel study to evaluate the~     efficacy and safety of Tolvaptan in the treatment of patients with cardiac edema (body fluid~     retention caused by congestive heart failure) based on the conventional therapy.~      To evaluate the efficacy and safety of Tolvaptan 15 mg on congestive heart failure patients~     with body fluid retention after current diuretic treatment, after continuous treatment of 7~     days' oral Tolvaptan 15mg or placebo.~   "
146374|NCT01651143|"~     Primary Objective:~      - To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients~     with diffuse cutaneous systemic sclerosis.~      Secondary Objectives:~        -  To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis~          as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor~          signaling markers in blood and skin;~        -  To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis~          as measured by the modified Rodnan Skin Score (mRSS);~        -  To explore the effect of SAR100842 on quality of life as measured by the Scleroderma~          Modified Health Assessment Questionnaire (SHAQ);~        -  To document long term safety of SAR100842 during the extension part.~   "
146455|NCT01650090|"~     To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in~     delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission~     following one or two prior pulmonary relapses.~   "
146375|NCT01651130|"~     Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the~     most common uterotonic drug used to prevent and treat PPH in North America, however, there~     are some limitations to its use. Oxytocin has a very short duration of action, which requires~     a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians~     and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of~     carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post~     partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts~     4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater~     efficacy rate. However, a dose response study to determine the minimum effective dose of~     carbetocin has not yet been published. The investigators hypothesize that the minimum~     effective dose (ED90) is at least 20mcgs (or perhaps below) in women undergoing elective~     Cesarean delivery.~   "
146376|NCT01651117|"~     The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race~     population of poorly controlled diabetic Veterans. Also, the study aims to assess the effects~     of becoming a mentor on those who originally were mentees. It is expected that participants~     in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of~     race or ethnicity at the end of the intervention.~   "
146377|NCT01651104|"~     To evaluate the safety of a single intramuscular (IM) injection of trivalent adjuvanted~     influenza study vaccine, formulation 2012/2013, in elderly subjects and the antibody response~     to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and~     hemagglutination inhibition (HI) at approximately 21 days postimmunization in elderly~     subjects in compliance with the requirements of the current EU recommendations for clinical~     trials related to yearly licensing of influenza vaccines.~   "
146378|NCT01651091|"~     The purpose of this study is to investigate the effects of an eight-week long group-based~     secular intervention known as Meditation Awareness Training (MAT) on psychosocial functioning~     in prison participants.~   "
146379|NCT01651078|"~     The need for new technologies and devices in the field of neurosurgery is well established.~     In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser thermotherapy~     tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue~     caused by tumors and lesions. This post-marketing, multi-center study will include patients~     with metastatic tumors who failed stereotactic radiosurgery and are already scheduled for~     NeuroBlate procedure. The study will collect clinical outcome, Quality of Life (QoL) and,~     where feasible, healthcare utilization data for publication.~   "
146380|NCT01651065|"~     The purpose of this randomized trial is to study the efficacy of a novel social propagation~     intervention which integrates social network induction with health education for weight and~     metabolic control among patients with type 2 diabetes, BMI of 25-30+, and cardiovascular~     disease. The intervention takes place in the form of a community health program, where~     participants who enroll in this program will be asked if they would like to take part in the~     study to evaluate its efficacy. Thus, the investigators will study the efficacy of social~     networks in propagating changes in lifestyle factors for diabetes and chronic disease~     management~   "
146381|NCT01651052|"~     The purpose of this observational trial is to gather further clinical data to confirm the~     safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this~     trial population.~   "
146382|NCT01651039|"~     The purpose of this clinical research study is to find out the effects of a drug called~     panobinostat (LBH589) when given to people like you with multiple myeloma in combination with~     the drugs lenalidomide and dexamethasone. The safety of this combination of drugs will also~     be studied. Your physical state, changes in the state of your multiple myeloma, and~     laboratory findings taken while on-study will help us decide if panobinostat combined with~     dexamethasone and lenalidomide is safe and effective.~      This goal of this study therefore is to determine the activity of the combination of~     panobinostat thrice weekly every other week, lenalidomide, and weekly dexamethasone in a~     similar group of subjects. The doses of lenalidomide and dexamethasone will be that which is~     approved by the FDA for multiple myeloma and you will take each drug at a specific frequency~     over a 4 week (28 day) period. This period is called a study cycle.~   "
146383|NCT01651026|"~     The purpose of this study is to describe the diagnostic and treatment procedures employed for~     patients with rectal cancer in each participating center. Outcomes to treatment, costs of~     treatment will be described. Exploratory analyses will be done to identify factor that~     influence patient prognosis, as well as factors that predict patient response to treatment.~   "
146384|NCT01651013|"~     The purpose of this study is to describe the treatments received and outcomes of patients~     with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of~     the tumor, and to describe the costs of treatments. Information will also be collected~     regarding risk factors, variables among treatment centers and patients, and explorative~     analyses will be done to try to identify factors that impact prognosis and factors that~     predict tolerability and response to treatment.~   "
146385|NCT01651000|"~     This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact~     parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and~     tolerability of CTAP101 will also be evaluated~   "
146386|NCT01650987|"~     Evaluate the toxicities of cervix and corpus uteri carcinomas treatment~   "
146387|NCT01650974|"~     The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen~     therapy during diagnostic bronchoscopy.~   "
146388|NCT01650961|"~     The purpose of this study is to assess the effects of palonosetron on corrected QT interval~     duration during and after general anesthesia.~   "
146389|NCT01650948|"~     Patients with AMD will provide cheek cell samples to determine if their is a correlation~     between genotype (DNA markers) and phenotype (the type of AMD the patient has).~   "
146413|NCT01650636|"~     The purpose of this study is to test the effects of a videotelephone-delivered~     patient-partner dual-focused cognitive behavioral stress management intervention on chronic~     fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in~     patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that~     videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM)~     intervention improves patient CFS symptoms relative to a videophone-delivered patient-partner~     Health Information (PP-T- HI) condition.~   "
146390|NCT01650935|"~     Oxalate restricted diet is routinely prescribed in clinical practice of nephrolithiasis~     patients with hyperoxaluria. The effect of dietary oxalate on urinary oxalate is however~     controversial. Some studies do not implicate dietary oxalate as a major risk factor for~     nephrolithiasis. The Dietary Approaches to Stop Hypertension (DASH) diet, which is high in~     fruits and vegetables, moderate in low-fat dairy products, and low in animal protein~     represents a novel potential means of kidney stone prevention. The effect of a DASH-style~     diet on relative urinary supersaturations is however uncertain. Higher consumption of fruits~     and vegetables may increase urinary oxalate but also increases urinary citrate, an important~     inhibitor of calcium saturation.All the above data lead us to hypothesize that a DASH diet~     other than an oxalate restricted diet, which is routinely administered in clinical practice,~     might be beneficial in lowering urinary relative supersaturations of calcium oxalate in~     recurrent stone formers with hyperoxaluria.~      Recurrent stone formers with hyperoxaluria (urine oxalate>32.8) are allocated into 2 groups.~     The first group is prescribed an oxalate restricted diet. The second group are asked to~     follow a calorie-controlled DASH diet plan while drink water in the same amounts. 24-h urine~     is collected 2 times before study visits at baseline, 1 time on week 6 and 2 times at the end~     of the study.~   "
146391|NCT01650922|"~     To look for patterns of polymorphisms in DNA repair in both germline and tumor cells samples.~   "
146392|NCT01650909|"~     This study is an independent sub-study of the protocol titled PKU-016: A double-blind,~     placebo-controlled, randomized study to evaluate the safety and therapeutic effects of~     sapropterin dihydrochloride on neuro-psychiatric symptoms in subjects with phenylketonuria~     (PKU ASCEND).~      The primary objective of this study is to determine oxidative stress in patients with~     classical phenylketonuria (PKU) enrolled in PKU-016, using a brain scan (called an HMPAO~     SPECT) at baseline and 26 weeks, and blood redox biomarkers.~   "
146393|NCT01650896|"~     The typical delirium study between 1989 and 2005 compared delirium management in a specialty~     unit such as geriatric medicine with delirium management in general medicine (in most cases~     the research diagnosis of delirium was not communicated to the general medicine group). This~     study will provide open diagnosis of delirium by the CAM to both the geriatric medicine and~     general medicine groups (medical staff, patients, families) plus daily monitoring of delirium~     using digit span and delirium index which is reported to both patient groups. It will also~     compare confusion assessment method (CAM)to a novel diagnostic system of Paul Regal with~     respect to hard endpoints (survival and return home). Hypotheses: 1) General medicine can~     manage delirium as well as geriatric medicine when delirium is openly diagnosed and monitored~     daily (even in speciality units it is rare to find daily measurement of tools such as~     delirium index); 2) The Regal diagnostic system will be superior to the CAM in predicting~     hard endpoints (survival and return home rate for patients living in the community).~   "
146394|NCT01650883|"~     The purpose of this study is to determine whether one of two Vitamin D3 (cholecalciferol)~     oral treatment regimens is superior to the other in normalizing Vitamin 25 OHD serum levels.~     While these two regimens in the end provide equal total dosing, the two arms differ in~     frequency and dosing during a 40 day treatment plan. The primary endpoint will be a direct~     comparison of two dosing regimens of Vitamin D3 repletion at day 40 (+/- 3 days) using a~     paired T-test. Secondary endpoints include record of adverse events throughout the 40 day~     study period as well as changes in basic laboratory values including CMP and ionized Calcium.~      The investigators hypothesize that the Cholecalciferol (Vitamin D3) daily dosing arm of 5000~     IU daily will result in more efficient replacement as compared to the 50,000 IU dosing given~     every 10 days. Our goal will be to achieve a serum Vitamin 25 OH D level of > 50 mg/dL at day~     40. The investigators propose that 75% of the subjects on daily Vitamin D3 will achieve this~     level and that 35% of the subjects in the every 10 days dosing arm will reach this goal.~   "
146395|NCT01650870|"~     The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline~     lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the~     physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale~     (BBPS).~   "
146396|NCT01650857|"~     Pulmonary hypertension (PH) leads to impaired physical condition (PC), body composition (BC)~     and health-related quality of life (HRQOL). We hypothesized that a 3 week inpatient pulmonary~     rehabilitation (PR) improves PC, BC and HRQOL.~   "
146397|NCT01650844|"~     This project aims to improve guideline-based asthma care using enhanced communication and~     screening tools, telemedicine and directly observed therapy of preventive medications in city~     schools. Web-based screening will be used to identify children with persistent or poorly~     controlled asthma and to send reports to the child's primary care doctor. Children in the~     SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed a~     daily preventive asthma medication to be taken through school-based directly observed~     therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention for~     improving guideline based care, enhancing adherence to effective preventive medications and~     at reducing morbidity among young urban children with asthma.~   "
146398|NCT01650831|"~     The purpose of this study is to confirm equivalence of a new generation breath analyzer~     (Modified BreathID) in its ability to detect H. pylori compared to the currently approved~     BreathID® System.~   "
146399|NCT01650818|"~     The purpose of this study is to compare the safety and the effects of moderate-intensity~     aerobic endurance training to those of an usual physical therapy intervention on exercise~     capacity and quality of life in patients with amyotrophic lateral sclerosis (ALS).~   "
146400|NCT01650805|"~     The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients~     with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.~   "
146401|NCT01650792|"~     The main purpose of the study is to determine noninvasive markers of brain involvement in~     Chagas disease. In a subgroup of patients with high intensity transient signals (HITS) on~     transcranial Doppler monitorization, the investigators aim to determine the efficacy and~     safety of aspirin in preventing microembolization in patients with no previous history of~     stroke. Specific aims are listed bellow:~      (1) to establish brain magnetic resonance imaging markers of stroke risk in patients with~     Chagasic heart failure (HF); (2) to determine whether biomarkers can predict stroke risk in~     patients with Chagasic HF; and (3) to evaluate the efficacy of antiplatelet treatment in~     decreasing microembolization rate in patients with Chagasic HF.~   "
146404|NCT01650753|"~     Healthy adults referred to as the absence of intestinal disorders, liver and kidney problems,~     lactose intolerance, and no use of ongoing medication for chronic diseases will be recruited.~     This research study will test the persistence of the probiotic (healthy bacterial) strain~     Bifidobacterium longum spp. longum in the human gastrointestinal tract after it is consumed,~     how it is tolerated, and its interactions with other micro-organisms already present in your~     gastrointestinal tract. The strain used is similar to bacteria used in probiotic yogurts, and~     the species Bifidobacterium is generally regarded as safe. The patient will be asked to will~     be consume a probiotic powder containing Bifidobacterium longum spp. longum strain AH1206 and~     a placebo in a random order, with neither the patient nor the investigators knowing the~     identity of the preparations given. Persistence or presence of the probiotic strain will be~     based on analysis of fecal (stool or bowel movement) samples provided.~   "
146405|NCT01650740|"~     In recent years, there has been growing evidence that antidepressants are only marginally~     effective compared to placebo for mild to moderate depression. In other words, although many~     people improve when they take antidepressant medications, almost as many get better with~     placebo pills. One possible solution to this problem would be to give patients a trail of a~     placebo prior to giving them an antidepressant, however there are ethical issues with doing~     this deceptively. New evidence from other placebo-responsive disorders such as irritable~     bowel syndrome shows that people may benefit from placebos even if they know they are taking~     them. This study aims to determine whether giving placebos without deception to people with~     major depressive disorder followed by the option to switch to an antidepressant is an~     effective strategy. There will be 3 groups of subjects. The first group is a standard~     treatment arm and will receive duloxetine, an antidepressant. The second will be given a~     placebo with the option to switch to duloxetine if they do not improve. The third group will~     receive supportive clinical visits the option to switch to duloxetine if they do not improve.~     This design will allow us to determine whether a sequenced treatment of a placebo without~     deception and then the option to switch to an antidepressant is a viable strategy. It will~     also help us to determine to what degree the benefit comes from the ritual of receiving and~     taking the placebo tablet versus the benefit of visits with a doctor alone. The primary~     hypothesis is that there will be a less than 5% difference between response rates after 12~     weeks in the sequenced placebo-then-antidepressant treatment group (both subjects who have~     remained on placebo as well as those who have switched to the antidepressant will be~     considered as one group) compared to the immediate antidepressant therapy group.~   "
146406|NCT01650727|"~     The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib~     therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small~     lymphocytic lymphoma (SLL).~   "
146407|NCT01650714|"~     The proposed study will assess the efficacy and safety of the innovative endoscopic technique~     for the acquisition of full thickness gastric muscle wall biopsies. Having access to full~     thickness biopsies will allow an increased understanding of the pathophysiology of~     gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis,~     pseudoobstruction and other motility disorders. This information is essential to development~     of more targeted and effective therapy than currently available. Despite the high prevalence~     of functional gastrointestinal disorders and its significant impact on social and health care~     costs, the underlying cause is not well understood and there is no effective specific~     treatment to successfully alleviate patient symptoms.~   "
146408|NCT01650701|"~     The purpose of this study is to find out if lenalidomide when given along with rituximab can~     help to control the disease and also increase the length of your response (complete or~     partial response) compared to the standard of care rituximab chemotherapy treatment.~   "
146409|NCT01650688|"~     Epiblepharon is a very common condition among Asian children and is a fold of the skin and~     underlying pretarsal orbicularis muscle that overlaps the eyelid margin and pushes the lashes~     against the cornea. It is manifested by the anterior lamella overriding the posterior lamella~     which causes the lashes to brush against the cornea. Although the prevalence of epiblepharon~     is known to be high among Asians, its cause remains controversial. Several etiological~     factors may be involved in the pathogenesis of epiblepharon.~      Although epiblepharon in the lower lids lessens and disappears with age in many cases,~     surgery must be performed at an early age in severe cases in order to prevent ocular trauma~     as the vertically oriented cilia of the lashes can erode the corneal epithelium. Induced~     keratitis and astigmatism are indications for surgical intervention.~      Over our many years of surgical experience, the investigators came to realize that the~     severity of epiblepharon was reduced when patients were under general anesthesia during~     surgery. The purpose of this study was to investigate the role of the orbicularis muscle in~     the pathogenesis of lower lid epiblepharon and to analyze the differences in the severity of~     epiblepharon in the upright versus the supine position and before and after the induction of~     general anesthesia.~   "
146410|NCT01650675|"~     The purpose of this study is to assess the validity of an indirect computer-delivered~     screener for drug use and assess the efficacy of a computer-delivered brief intervention with~     urban post-partum women at-risk for substance abuse and HIV during the post-partum period.~   "
146411|NCT01650662|"~     Infarct size is a major determinant of prognosis after myocardial infarction (MI). It has~     been reported that Cyclosporine A (CsA) administered immediately prior to percutaneous~     coronary intervention (PCI) significantly could reduce reperfusion injury and consequently~     infarct size in ST elevation MI (STEMI) patients.~      CYCLE trial is a multicenter, controlled, randomized open label study, with blind assessment~     of endpoint measures. The objective is to determine whether a single i.v. dose of CsA within~     6 hour onset of symptoms of STEMI in 444 patients, improves outcomes after successful primary~     PCI, by reducing myocardial injury associated to reperfusion.~   "
146412|NCT01650649|"~     The primary objective of this study is to assess QTc (an interval of the heart rhythm)~     interaction effects between lofexidine and methadone. The secondary objectives of the study~     are to evaluate the safety and tolerability of lofexidine by evaluating and monitoring~     pharmacokinetics (amounts of drug in the blood), vital signs (heart rate and blood pressure)~     and adverse events (side effects) when co-administered with methadone; to describe effects on~     opiate withdrawal when lofexidine is introduced following a 50% methadone dose reduction, as~     required to elicit a withdrawal response; and to evaluate the QTc interaction effects of~     lofexidine compared with placebo. The investigators hypothesize that while both agents~     (lofexidine and methadone) are known to prolong the QTc interval, the combination of the~     drugs will not create an additive effect which creates a significant safety concern. The~     investigators further hypothesize that subjects will be able to tolerate the therapeutic dose~     of lofexidine (0.8 mg four times daily) when the methadone maintenance dose is lowered to~     elicit withdrawal.~   "
146439|NCT01650298|"~     The purpose of this study is to determine whether it is safe to stop anticoagulation~     medication in patients with a history of atrial fibrillation (AF) based on information from a~     pacemaker or implantable cardioverter defibrillator (ICD).~   "
146414|NCT01650623|"~     The aim of this study is to compare two physical therapy training consisting of gait training~     that are distinguished by one being associated with tasks that require handling of the main~     executive functions, performed by individuals with Parkinson's Disease.~      The investigators hypothesis is that the experimental group (EG), which hold gait training~     with higher cognitive demands (dual-task condition), will make improvements in the parameters~     measured (functionality of gait and cognitive ability) to a greater extent compared to the~     control group (CG), which hold gait training without executive tasks (single-task condition).~   "
146415|NCT01650610|"~     The aim of this study is the development and implementation of a new protocol of a physical~     therapy training, based on a gait training associated with executive tasks, for treatment of~     individuals with Parkinson's Disease.~      The hypothesis is that this group of patients who will carry out training of this study~     protocol will show improvement in measured parameters (functionality of gait and cognitive~     ability), which allows this protocol to be improved and published as a proposal of~     physiotherapeutic treatment.~   "
146416|NCT01650597|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     single ascending doses as well as repeated doses of JNJ-42165279 in healthy male~     participants.~   "
146417|NCT01650584|"~     To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease~     (DED)~   "
146418|NCT01650571|"~     Currently, standard wound care practice is suboptimal at assessing wound remodeling and~     bacterial infection in real-time. An alternative and complimentary means of providing~     real-time imaging of connective tissue re-modeling and bacterial infection may greatly~     increase the early detection of infection thus leading to rapid therapeutic intervention. Our~     new device, PRODIGI(TM), images tissue and bacterial autofluorescence (without agents) and~     may provide this clinically-important capability.~      In preliminary preclinical testing, the investigators have discovered that when wounds are~     illuminated by violet/blue light, endogenous collagen in the connective tissue matrix emit a~     characteristic green fluorescent signal, while most pathogenic bacterial species emit a~     unique red fluorescence signal due to the production of endogenous porphyrins. Therefore,~     with autofluorescence imaging, no exogenous contrast agents are needed during imaging, making~     this approach particularly appealing as a diagnostic imaging method for clinical use.~      The investigators hypothesize that real-time imaging of tissue autofluorescence signals~     emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within~     complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound~     closure), detect wound bacterial contamination and/or infection that is occult under standard~     clinical white light evaluation, and guide intervention and wound care.~   "
146419|NCT01650558|"~     The purpose of this study is to determine if there is a benefit to taking~     trimethoprim-sulfamethoxazole (TS) as prophylaxis among HIV positive adults who have viral~     load suppression and a good clinical response on anti-retroviral therapy (ART). If there is a~     benefit, then is it due to antimalarial or antibacterial properties.~      The investigators hypothesize that there will be a long-term benefit on survival and disease~     control in the context of prophylaxis and that the benefit will largely be attributed to~     prevention of malaria. The main study hypothesis is that 1)TS and chloroquine (CQ) will~     decrease the rates of morbidity and mortality among adults after 6 or more months of ART and~     2) CQ prophylaxis will be associated with more prolonged viral suppression and higher CD4~     cell counts than TS prophylaxis or no prophylaxis.~   "
146420|NCT01650545|"~     This is a single-center pilot study to investigate the efficacy and safety of aerosolized~     liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients~     with bronchiolitis obliterans syndrome (BOS).~      The primary objective is to evaluate the efficacy of liposomal cyclosporine A in the~     treatment of chronic rejection. Pulmonary function and changes in BOS grade are the primary~     end points.~   "
146421|NCT01650532|"~     The investigators propose to test the effects of an 8-week supervised, site-based, group yoga~     intervention on cognition and functional fitness in older adults. The SAY Exercise study will~     compare the yoga group to a stretching group to determine if the program improves attention~     and cognition, reduces functional limitations, enhances functional performance in everyday~     activities, as well as psychological health in sedentary older adults between 55-80 years of~     age. The investigators also propose to assess heart rate variability using a 3-lead EKG and~     salivary cortisol levels to understand the moderators of the yoga-cognition relationship.~   "
146422|NCT01650519|"~     The intent of this study is to assess the analgesic efficacy of IV ibuprofen when~     administered at induction of anesthesia. Results from this pilot study will be used to design~     and determine the appropriate statistical power for a larger, multi-center randomized study.~   "
146423|NCT01650506|"~     Extended phase 1 trial of combined metformin and erlotinib in advanced triple negative breast~     cancer patients. The goals of the study are to establish the maximum tolerated combined~     dosing of erlotinib and metformin as well as deciding if there is a potential clinical~     utility of the combination in treating patients with triple negative breast cancer.~   "
146424|NCT01650493|"~     Three toothpastes will be compared, two toothpastes in each subject, to establish whether~     changes in the depth or area of an artificially created area of tooth decay is the same for~     each toothpaste.~   "
146425|NCT01650480|"~     The purpose of this study is to develop, refine and pilot a novel complex (HELP-COPD)~     assessment, undertaken during or immediately after a hospital admission, which addresses the~     holistic care needs of people with severe chronic obstructive pulmonary disease (COPD).~   "
146426|NCT01650467|"~     The main objective of this study is to evaluate the existence of a relationship between the~     presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence~     of primary resistance to the treatment of CML by imatinib.~   "
146452|NCT01650129|"~     This trial is conducted in Japan. The aim of this trial is to investigate the safety and~     efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human~     insulin (BHI) 50 in subjects with type 2 diabetes.~   "
146453|NCT01650116|"~     The purpose of this study is to verify any existing relationship between urinary parameters~     (such as excretion of sodium, chlorine, urinary partial CO2 pressure [PuCO2]) and general~     volemic indicators (such as PiCCO, ScvO2, O2 delivery) during liver transplant.~   "
146427|NCT01650454|"~     The increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the~     aging of the population is a major issue of public health. The prevalence of sleep~     disturbances is about 50% in dementia patients. Sleep in dementia is mainly characterized by~     prolonged night-time awakenings, sometimes with longer sleep latency and/or early awakening.~     The presence of these sleep disturbances is the main reason for the institutionalization of~     AD patients, as well as a major cause of the deterioration of the caregivers' sleep. The~     MEMENTO cohort is composed of patients with isolated memory complaints or mild cognitive~     impairment, at high risk to develop dementia. All voluntary patients from the CMRR (Center of~     Memory, resources and Research) of Bordeaux (MEMENTO cohort) will be tested at inclusion and~     followed-up 1 year later. For these two evaluations, actigraphic monitoring at home, 2-night~     polysomnography (PSG) monitoring at hospital including a 24-hour period of urinary melatonin~     dosage, neuropsychological tests battery, a virtual reality tool and questionnaires will be~     used.~   "
146428|NCT01650441|"~     The objective of this study is to evaluate the effect of the combination of formoterol and~     beclometasone dipropionate in a dry powder inhaler (NEXThaler®) on central and peripheral~     airway dimensions in asthmatic patients. Therefore Computational Fluid Dynamics (CFD) will be~     used. Further more, the effect of this combination therapy on lung function (spirometry,~     resistance and diffusion), the Asthma Control Test (ACT™) and the Asthma Control~     Questionnaire (ACQ) will be assessed and the safety will be evaluated.~   "
146429|NCT01650428|"~     The purpose of this study is to evaluate the efficacy, toxicity and feasibility of FOLFOX/~     bevacizumab and FOLFOXIRI/ bevacizumab neoadjuvant therapy in poor prognosis rectal cancer as~     defined by MRI.~   "
146430|NCT01650415|"~     This randomized placebo-controlled trial aims to investigate the efficacy and safety of~     erythropoetin for children with cerebral palsy.~   "
146431|NCT01650402|"~     This study will evaluate different treatment strategies for high blood pressure using~     medications approved by the US Food and Drug Administration (FDA) for the treatment of high~     blood pressure. The study will compare the effects of an intensive reduction of 24-hour~     average blood pressure to a standard reduction of 24-hour mean blood pressure on controlling~     declines in mobility (speed and agility of walking) and cognition (ability to think and~     process information) in an aging population.~   "
146432|NCT01650389|"~     Rationale: The Bacille Calmette-Guérin (BCG) vaccine protects children against disseminated~     tuberculosis (TB) including TB meningitis and miliary TB, but efficacy against pulmonary TB~     is inconsistent among children and adults. Administration of live attenuated BCG to infants~     known to be HIV infected is contraindicated by the World Health Organization (WHO), due to~     the risk of serious vaccine adverse events (BCG disease. Developing countries, which lack~     capacity for integration of early infant HIV testing with infant vaccination schedules, have~     not fully implemented the WHO guidelines on BCG vaccination of HIV exposed infants. Newborn~     infants of HIV infected mothers continue to receive routine BCG before HIV infection has been~     excluded.~      Clinical trials of new viral-vectored TB vaccines, including MVA85A, a modified vaccinia~     virus Ankara (MVA) vaccine expressing the Mycobacterium tuberculosis antigen 85A, have to~     date enrolled infants who were already vaccinated with routine BCG at birth. However, TB~     vaccination regimens that depend on newborn BCG will remain unsafe for HIV infected infants.~     Infants of HIV infected mothers, who constituted 29% of babies born in South Africa in 2009,~     would benefit from a new TB vaccination strategy, in which BCG is delayed until after HIV~     infection has been excluded. These HIV exposed infants also have greater increased risk of TB~     disease. Testing the safety and immunogenicity of MVA85A vaccine prime, followed by selective~     delayed BCG boost, in HIV exposed newborns, is a critical step towards delivery of a new TB~     vaccine regimen that is safe and effective for all infants, regardless of HIV exposure.~      Study Design: Double blinded, randomised, controlled trial. HIV exposed infants will be~     randomised 1:1 to receive single dose, intradermal MVA85A vaccine or Candin® control at~     birth. The first 60 infants enrolled in the trial will form a pilot safety cohort for formal~     Data Monitoring & Ethics Committee (DMEC) safety review. Thereafter, safety and~     immunogenicity outcomes will be measured in all infants.~      Study Population: Infants (n=340) born to HIV infected mothers receiving antiretroviral~     therapy (ART) or Prevention of Mother to Child Transmission (PMTCT) prophylaxis.~      Sites: Worcester (University of Cape Town) and Khayelitsha (Stellenbosch University), South~     Africa~      Study Intervention: Newborn infants will receive 1 x 108 pfu MVA85A vaccine or Candin®~     control by intradermal injection. Infants confirmed HIV uninfected by HIV PCR will receive~     BCG Vaccine SSI at 8 weeks of age. Infants confirmed HIV infected by HIV PCR will not receive~     BCG.~      Primary specific aims:~      To evaluate the safety of MVA85A given at birth to HIV exposed uninfected infants.~      To evaluate the safety of BCG given at 8 weeks of age to HIV exposed uninfected infants,~     using an MVA85A prime and BCG boost strategy.~      Secondary specific aims:~      To evaluate the immunogenicity of MVA85A given at birth to HIV exposed uninfected infants.~      To evaluate the immunogenicity of BCG given at 8 weeks of age to HIV exposed uninfected~     infants, using an MVA85A prime and BCG boost strategy.~      Safety endpoints:~      Local, regional, and systemic adverse events (AEs) and serious adverse events (SAEs).~      Immunology endpoints:~      Frequencies of CD4 and CD8 T cells producing any of 4 cytokines (IL-17, IFN-γ, TNF-α, or~     IL-2), or polyfunctional combinations of these cytokines simultaneously, following~     stimulation with antigen Ag85A or BCG, measured by whole blood intracellular cytokine assay~     (WB-ICS).~      Specific proliferative capacity of CD8 and CD4 T cells that produce any of the three~     cytokines (IFN-γ, TNF-α, and/or IL-2) or combinations of these cytokines simultaneously,~     measured by a novel whole blood 6-day lymphoproliferative flow cytometric assay (WB-prolif).~      Relative proportions and absolute numbers of peripheral blood myeloid and lymphoid cell~     subsets, measured directly ex vivo by flow cytometry.~      Study groups: The first 60 infants enrolled in Study Group 1 will undergo intensive safety~     evaluation, followed by DMEC review of Day-28 safety data. The DMEC will make a formal~     recommendation on continuation of enrollment and/or changes to the protocol, based on this~     safety review. Study Groups 2-5 will be evaluated for clinical safety and immunology~     outcomes.~      Statistical Analysis: Cumulative 12-month incidence of local, regional, and systemic AEs, by~     category, will be compared for HIV exposed uninfected subjects receiving MVA85A vaccine or~     Candin® control at birth. The sample size has 90% probability of detecting an SAE with a true~     occurrence rate of 1.5% in infants receiving MVA85A vaccine and 80% power to detect a 15%~     difference in the rate of non-serious AEs (20% compared to 35%) between the two study arms~     (p<0.05). Multivariate models will be built to explore longitudinal immunological data and~     identify independent associations with MVA85A vaccination and covariates of interest.~   "
146433|NCT01650376|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of the~     investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in~     patients with relapsed ovarian cancer or uterine cancer. Furthermore, the investigators~     intend to study the safety and tolerability of the study treatment, response to treatment,~     time to disease progression, and overall survival.~   "
146434|NCT01650363|"~     This is a randomized controlled clinical trial in which the combination of 4 different CAM~     modalities (Complementary & Alternative Medicine) will be applied during the postoperative~     period to patients undergoing open heart- or lung surgery and expected to be hospitalized for~     more than 5 days.~      Elective and Urgent surgical patients will be randomly assigned to a treatment - and to a~     control group. The treatment group will be treated with a combination of 4 different CAM~     modalities (Homeopathy, Osteopathy, and Acupuncture & Reflexology) . The control group will~     be treated with Homeopathic placebo medication.~      The main Outcome measurement in the study will be the Quality of recovery 40 questionnaire~     (QoR- 40) that will be filled out on postoperative days: 3, 5, and 7 respectively. Secondary~     outcome measurements will be Blood &Saliva Cortisol levels, DHES levels in the blood as~     surrogates of stress, IL-2 levels as measures of the immune system. Further parameters to be~     measured include: LOS (length of stay), Level of Pain, mobility, level of satisfaction, GI~     symptoms (nausea, first bowel movement), post-operative complications& side effects.~      All patients participating in the trial will sign an informed consent form . The trial is~     expected to be conducted over a period of 12 months. Prior to the trial a pilot study will be~     conducted on a group of 30 patients in order to determine the needed sample size for the~     trial.~   "
146435|NCT01650350|"~     will scientifically evaluate whether Low Dose Naltrexone (LDN) has activity in refractory~     solid tumors within the context of a phase II clinical study~   "
146436|NCT01650337|"~     BACKGROUND: The nascent field of mobile health (mHealth) is expanding with impressive speed.~     In March 2012, experts estimated that 40,000 health related smartphone applications were on~     the market but little is known about the effectiveness of these programs. To our knowledge,~     no studies have evaluated whether weight loss can be successfully achieved through use of a~     smartphone application or how these applications could be used in primary care practice.~      PURPOSE: To evaluate the effectiveness of a popular, free smartphone application for weight~     loss and calorie counting in a primary care setting.~      METHODS: The first phase of this study involved a community based participatory approach to~     select the intervention. Patient focus groups were conducted and analyzed to explore~     patients' preferences regarding various text-message versus smartphone programs. The second~     phase of this study, described here, will be a randomized controlled trial with overweight~     primary care patients exposed to one of two conditions for 6 months: (1) usual care; (2)~     usual care plus smartphone application, which includes instructing participants on how to use~     the application and encouraging them to use the applications' reminders and social networking~     features. The primary outcome of interest is weight change at 3 and 6 months. Two-sample~     t-test or Wilcoxon rank sum test will be used to compare weight change between groups, as~     appropriate. ANCOVA models will be used to examine weight change after adjusting for~     covariates such as education, sex and age. Repeated measures analysis will be carried out to~     compare weight change between the groups using baseline, 3 month and 6 month data. In~     addition to an intent-to-treat analysis, the investigators will also conduct a treatment~     received analysis, adjusting for the extent of application use in both the intervention and~     control arms.~      CONCLUSIONS: This study will demonstrate whether a smartphone application introduced in~     primary care settings and incorporated into the visit can produce weight loss. Study findings~     could inform a national discourse on the value of smartphone applications in routine clinical~     practice.~   "
146437|NCT01650324|"~     The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and~     pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male subjects.~   "
146438|NCT01650311|"~     Alterations in normal serotonin (5-hydroxytryptamine;5-HT) signaling have been reported in~     ulcerative colitis (UC) and Crohn's disease (CD). Studies report an increase in~     enterochromaffin (EC) cell, main source of 5-HT in the gut, numbers in CD and UC patients.~     Up-regulated expression of mucosal Tryptophan hydroxylase (TPH)-1, catalytic enzyme in 5-HT~     production, messenger RNA (mRNA) have been found in CD patients in remission who are~     suffering the irritable bowel syndrome (IBS)-like symptoms. Alterations in normal 5-HT~     signaling has also been reported in animal models of inflammatory bowel disease (IBD). Thus,~     the aim of the proposed research project will be to study the alterations in 5-HT signalling~     accompanying GI inflammatory conditions, such as IBD.~   "
146440|NCT01650285|"~     There is a high relapse rate for patients who have undergone prostatectomy and have~     pathologic extracapsular prostate extension, positive surgical margins or seminal vesicle~     involvement (pathologic stage 3 disease). While adjuvant radiation improves progression-free~     and overall survival, approximately half of these patients will develop recurrence.~     Similarly, radiation therapy has become the standard salvage therapy for patients with rising~     PSA >0.1 - < 2.0 ng/mL. In common solid tumors such as NSCLC, head and neck cancer and upper~     gastrointestinal cancers, the addition of chemotherapy to radiation improves survival. It is~     hypothesized that the addition of radiosensitizing chemotherapy to standard adjuvant~     radiation will improve survival in patients with stage 3 prostate cancer after prostatectomy~     and patients with rising PSA < 2.0 ng.mL without detectable disease. Taxanes are powerful~     radiation enhancers since they synchronize tumor cells in G2/M the most radiosensitive phase~     of the cell cycle.17,18 Cabazitaxel is the most active taxane in the treatment of prostate~     cancer. Therefore, we propose a phase I study establishing the optimal dose of cabazitaxel~     with adjuvant radiation for stage 3 prostate cancer after prostatectomy (PSA undetectable - <~     2.0 ng/mL). and for patients with persistent or rising PSA post prostatectomy (PSA >0.1 - <~     2.0 ng/mL).~   "
146441|NCT01650272|"~     5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic~     alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5%~     Minoxidil in solution is the first choice preparation for treatment, therefore allergic~     contact dermatitis to solution was report up to 5.7% (Ebner H. et al,1995). Propylene glycol~     which is the main solvent of these solution, was the main responsible to allergic contact~     dermatitis with positive patch test up to 81.8% (Friedman ES. et al. 2002) One of the~     alternative solution using butylene glycol as the solvent was invented to solve the problem.~     In Siriraj hospital the investigators using this new solvent and made our in house product~     called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have~     not been investigated. This study is conducted to evaluated efficacy and safety of 5%~     Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.~   "
146442|NCT01650259|"~     Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as~     monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics~     of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral~     antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic~     drug).~   "
146443|NCT01650246|"~     This study will assess the serum uric acid lowering effects and safety of lesinurad over a~     long-term timeframe.~   "
146444|NCT01650233|"~     This study assesses the impact of a mindfulness-based stress reduction program compared with~     a health education program for urban middle-school male youth on outcomes of psychological~     symptoms, coping, stress, sleep, and behavior.~   "
146445|NCT01650220|"~     This is an observational study designed to determine whether veterans with PTSD have a higher~     risk of heart disease than those without PTSD. Cardiovascular risk will be assessed by~     interview and review of medical records, carotid artery ultrasound, and blood tests measuring~     markers of inflammation. Study participation is approximately 6 months. The eligible study~     population is veterans of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF),~     age 28 through 38 years.~   "
146446|NCT01650207|"~     Shoulder pain has been reported to be one of the most common complications after stroke.~     Several factors have been related to shoulder pain after stroke such as paralysis, restricted~     range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship~     between these factors and pain was not discussed.~      The aim of this study is to identify the efficacy of electroacupuncture in reducing upper~     limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life~     (QOL) for stroke patients.~   "
146447|NCT01650194|"~     The purpose of this study is to explore the safety and tolerability of enzalutamide in~     combination with abiraterone acetate plus prednisone. Subjects diagnosed with cancer of the~     prostate that is getting worse and spread to the bone despite receiving hormone treatment~     will be enrolled and receive study treatment until disease progression.~   "
146448|NCT01650181|"~     Non-alcoholic steatohepatitis represents 10 - 15% total cases of hepatic cirrhosis. In the~     upcoming years, the economic burden of this disease will increase and will mean an important~     problem for our health system due to obesity epidemic.~      There are several treatments for non-alcoholic steatohepatitis; however, none of them have~     overcome a healthy lifestyle including diet, exercise and some drugs related with insulin~     metabolism.~      There after, using hepatoprotective drugs and antioxidants have been recommended as an~     eligible therapy to reduce the progression from fatty liver to steatohepatitis and cirrhosis.~     Being this approach not only an experimental item yet but also an unavoidable reality.~      The purpose of this randomized controlled study is explore the effects of~     siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with~     fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic~     parameters.~   "
146449|NCT01650168|"~     This study compares the risks of short- and long-term use of NOMAC-E2 (containing a fixed~     dose of nomegestrol acetate and estradiol) compared with levonorgestrel-containing combined~     oral contraceptives (COC-LNG) in a study population representative of the actual users of the~     individual preparations.~   "
146450|NCT01650155|"~     To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following~     intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection.~     Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics~     of BI 1005273.~   "
146451|NCT01650142|"~     Thanks to the investigators previous study the investigators demonstrated the influence of~     modifying genes in the phenotypic expression of neurofibromatosis 1 (Hum Mol Genet. 2009; 18~     (15) :2768-78). Indeed, analysis of the intra-and inter-family variability performed using~     the investigators phenotype/genotype database demonstrated a strong genetic component for~     most clinical features. The investigators results suggest the involvement of genetic factors,~     not related to the NF1 gene, the modifiers. The objective of this project is to identify the~     modifiers involved in the variability of clinical expression of NF1. The investigators will~     focus in particular variants involved in the development and progression of neurofibromas.~   "
146458|NCT01650051|"~     The primary objective is to evaluate the safety and efficacy of Phenazopyridine HCl Tablets,~     USP 200 mg as a short term analgesic treatment of pain upon urination associated with~     Uncomplicated Urinary Tract Infections (uUTI).~      The secondary exploratory objective is to evaluate safety and efficacy of Phenazopyridine HCl~     Tablets, USP 200 mg as a short term analgesic treatment of burning upon urination associated~     with uUTI.~   "
146459|NCT01650038|"~     Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon.~     Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early~     adulthood and lead to life-long substantial morbidity. There is no medical treatment~     available that meets the desired criteria of high efficacy versus low adverse effects. The~     current prevailing hypothesis regarding the cause of UC states that the pathogenesis involves~     an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal~     microbiota in a genetically predisposed individual. Systematic investigation into the effect~     of correcting the dysbiosis in ulcerative colitis patients has never been performed. The most~     radical way to restore the presumably disturbed natural homeostasis in UC is to perform~     faecal transplantation from a healthy donor. In this trial the potential beneficial effects~     of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be~     studied in a phase II randomised placebo controlled design.~      Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks~     (primary), as well as time to recurrence, intra individual changes in faecal samples and~     mucosal biopsies. Follow up is 12 months.~   "
146460|NCT01650025|"~     Obesity in children has become a significant social problem considering that nowadays 4 to 5~     % of all children are obese in the industrialized countries with increased incidence in~     Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic syndrome~     in 30% of the children and is considered as a state of chronic inflammation inducing the~     production of pro-inflammatory cytokines which determine metabolic and endocrine alterations~     on the organism. It has been observed that obesity is also linked to a change in the~     intestinal microflora with a reduction of Bacterioides and bifidobacteria and a decrease of~     Firmicutes and Staphylococcus aureus. The qualitative and quantitative analysis of the~     metabolites may provide us with a characterization of the existing phenotypes and variations~     in relation to the changes of the physiological state, in particular when supplemented or not~     with a probiotic preparation.~   "
146461|NCT01650012|"~     Forty percent of patients that require dialysis for kidney failure die within three years~     mostly due to heart disease. Heart failure and high blood pressure are common problems in~     patients that require dialysis and are key causes of death due to heart disease. Eplerenone~     is a drug that is very effective at improving heart failure and reducing blood pressure in~     patients that do not require dialysis. There is currently no evidence to tell physicians~     whether eplerenone would have similar benefits in patients that require dialysis. This~     evidence can only be reliably generated by performing a large scale study. Before such a~     study is undertaken, the investigators must determine whether eplerenone will be well~     tolerated and safe in patients that require dialysis. The investigators will perform an~     initial small trial called the Pilot trial in Hemodialysis patients undergoing Aldosterone~     antagoniSm with Eplerenone (PHASE) to determine if eplerenone is a well tolerated, safe~     medication to use in a very large, global study that will show whether or not eplerenone~     reduces important outcomes for patients like death from heart causes.~   "
146462|NCT01649999|"~     This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the~     dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects~     given ASP015K for 12 weeks.~   "
146463|NCT01649986|"~     Cardiovascular prevention include a class I indication to statins in addition to~     non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk'~     according to current scientific guidelines. In the real world, however, statin treatment is~     often discontinued due to side effects.~      In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom~     only non-pharmacologic intervention and prevention strategies are currently prescribed.~      Along with non-pharmacologic intervention and prevention strategies, newer approaches to~     reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived~     from foods with cholesterol lowering actions.~      The primary objective of this study is twofold:~      First, to prospectively compare in the real world clinical practice the efficacy and~     tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic~     intervention with a nutraceutical-based protocol in patients in whom statin treatment is not~     tolerated or is not indicated.~      Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a~     nutraceutical-based protocol among European countries.~   "
146464|NCT01649973|"~     Laryngeal view of the patient and anesthesiologist's discomfort level during endotracheal~     intubation in relation to the various heights of operating table has not been investigated.~     The investigators hypothesis is higher table height will improve the laryngeal exposure.~   "
146465|NCT01649960|"~     The investigators will do the study in two phases. The first phase will be a pilot study on~     up to 18 participants [patients 60 years or older with coronary artery disease (CAD)~     undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)~     or patients who are eligible to undergo and participate in cardiac rehabilitation (CR)]; up~     to 6 participants each will be given oral daily rapamycin (0.5, 1, and 2mg) dose for the~     duration of CR. Baseline and follow-up data will be collected for age-associated impairment~     (AAI): frailty (primary endpoint) and quality of life (QOL),senescent-associated secretory~     phenotype (SASP)and abdominal/thigh subcutaneous adipose biopsy for measurement of adipocyte~     mitochondrial DNA copy number and to quantitate the number of senescent preadipocytes. Safety~     of rapamycin will be assessed by periodic clinical follow-up, blood draws, and serum~     rapamycin levels. Following completion of the pilot phase, the data will be analyzed. If~     favorable changes are noted in the SASP or AAI, the investigators will start a phase 2~     randomized trial.~      Second phase: In a prospective, randomized, clinical trial design, patients 60 years or older~     will be randomized at the time of CR to a standardized exercise protocol, or exercise~     protocol with the addition of low-dose rapamycin to test the hypothesis whether low-dose~     rapamycin (demonstrated in the pilot trial to improve SASP/AAI) will improve measures of AAI,~     SASP, or findings on the fat biopsy as compared to exercise alone. The null hypotheses are~     that there is no improvement with rapamycin in measures of AAI or SASP.~   "
146466|NCT01649947|"~     The purpose of this study is to examine the combination of one standard treatment for lung~     cancer plus an additional drug, hydroxychloroquine. The standard treatment for lung cancer~     being used includes 2 chemotherapy drugs, called paclitaxel and carboplatin. Some patients~     who have a specific type of lung cancer can also receive another drug, a drug that targets~     blood vessels, called bevacizumab (also known as avastin). Hydroxychloroquine is an FDA~     approved drug for the treatment of malaria, rheumatoid arthritis and lupus erythematosis.~   "
146467|NCT01649934|"~     The purpose of the current pilot study will be to utilize implementation intentions to~     increase patient compliance with appointment attendance. Participants in the current study~     will be individuals referred for evaluation of their treatment needs. Experimental groups~     will create a simple induction consisting of what/when/where statements (implementation~     intentions) with the intention of increasing their rate of calling to schedule and~     subsequently attend appointments associated with their care. It is anticipated that~     participants who take an active role in their plan and utilize the implementation intention~     procedures will be more likely to make and attend the appointments suggested by their~     treating clinician. This pilot project will provide valuable initial data as to the potential~     effectiveness of a simple, cost-effective means of increasing appointment attendance. If~     successful, it could lead to cost savings and a decrease in the appointment wait time for~     people by increasing the utilization of available appointments.~   "
146468|NCT01649921|"~     The primary aim of this study is to assess the effects of adjunctive therapy with Interferon~     (IFN)-gamma on immune function in patients with septic shock in a placebo-controlled manner.~     Moreover, the investigators want to evaluate new markers that could be used to identify~     patients with immunoparalysis, and to monitor the patient's immunological response to IFN-γ.~     In addition, mechanistic studies will be performed to further elucidate mechanisms (such as~     epigenetic modifications) behind immunoparalysis and the effects of IFN-γ on these~     mechanisms. With use of the results the investigators will obtain in this pilot study, the~     investigators will conduct a large multicentre clinical trial with IFN-γ.~   "
146469|NCT01649908|"~     Different cross clamping techniques in aortic surgery causes different cardiac stress~   "
146470|NCT01649895|"~     The purpose of this study is to examine if D-Cycloserine is an effective adjunct to~     internet-based cognitive behaviour therapy for patients with obsessive-compulsive disorder.~   "
146471|NCT01649882|"~     Correct positioning of the endotracheal tube (ETT) is crucial to ensure safe ventilation. To~     date, no test that can verify this right after intubation at the bedside exists. Indirect~     tests have false negative and positive results leading to complications or at least~     difficulties in performing effective ventilation of patients.~      Bedside ultrasound could fill this need. Although bedside ultrasound may not be possible or~     useful in routine intubations, it may prove useful in difficult or questionable cases, where~     current clinical exams/techniques may not offer a reliable indication of endotracheal tube~     depth.~   "
146472|NCT01649869|"~     This is an international, multi-center, double-blind, placebo-controlled evaluation~     valganciclovir treatment for up to 54 children (up to 4 years of age) with~     virologically-confirmed congenital CMV infection and hearing loss. Subject participation will~     be over a six-month period and study subjects will be stratified according to age. The~     primary objective is to assess whether a six-week course of oral valganciclovir can stabilize~     the hearing of children with congenital CMV infection who present with hearing loss.~   "
146473|NCT01649856|"~     This multicenter, randomized, open label parallel-group study will evaluate the efficacy and~     safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with~     CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell~     lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg~     subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8~     cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study~     treatment is 6 months.~   "
146474|NCT01649843|"~     Achalasia is a rare esophageal motility disorder, which is characterized clinically by~     symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are~     primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal~     sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus.~     Unfortunately, no therapy returns normal esophageal function. Treatment is therefore directed~     at lowering the LES pressure, with the aim of reducing the functional obstruction to bolus~     transit at this site. Current treatments can be endoscopic or surgical. Peroral endoscopic~     myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy~     technique intending a permanent cure from primary achalasia in some centers. The~     investigators purpose was to further evaluate the efficacy and the feasibility of POEM for~     patients with achalasia in a prospective larger study.~   "
146475|NCT01649830|"~     Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative~     nature and frequent growth in eloquent area in brain often makes total resection impossible.~     Until now, no agreement has been achieved on the treatment of LGG without total resection.~     Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade~     gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas.~     However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to~     be defined. In this randomized controlled trial, the investigators will test the hypothesis~     that radiotherapy with subsequent TMZ chemotherapy is superior to improve the~     progression-free survival of patients with residue LGG without significant impairment to~     quality of life compared to radiotherapy alone.~   "
146476|NCT01649817|"~     This multicenter, retrospective observational study will evaluate compliance an reasons for~     withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with~     intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be~     collected from each eligible patient over a period of 6 months.~   "
146477|NCT01649804|"~     This extension study of WA19926 will assess the long-term safety and the efficacy of~     RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis.~     Participants who have completed the core study WA19926 are eligible to participate.~     Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The~     anticipated time on study drug is 104 weeks.~   "
146478|NCT01649791|"~     This clinical trial studies lenalidomide as chemoprevention in treating patients with~     high-risk, early stage B-cell chronic lymphocytic leukemia (B-CLL). Chemoprevention is the~     use of certain drugs to keep cancer from forming. The use of lenalidomide may slow disease~     progression in patients with early stage B-cell chronic lymphocytic leukemia~   "
146479|NCT01649778|"~     This is a global, multi-centre, long-term, prospective, observational study to evaluate~     treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated~     for the first time with pazopanib. The study is designed to enroll approximately 700-1000~     patients in over the course of an enrollment period of approximately 18 months.There are no~     protocol-mandated visits or procedures associated with the study. Each patient is expected to~     participate for a maximum of 30 months or until premature discontinuation (i.e., due to~     death, withdrawal of consent, lost to follow-up or study termination).~   "
146480|NCT01649765|"~     This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of~     belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic~     lupus erythematosus~   "
146481|NCT01649752|"~     Background:~      Improving implantation rates in ICSI cycles has been the focus of research in recent decades.~     Because success rates is not satisfactory enough especially when transferring good embryos to~     the uterine cavity and pregnancy does not occur. Trying to improve endometrial receptivity,~     the investigators have thought about stem cell therapy as stem cells have played a pivotal~     role in regenerative medicine in many pathologies as myocardial infarction, Diabetes Mellitus~     and spinal cord injuries.~      Garget and Healy reported in 2011 treatment of a case with Asherman's syndrome by~     administration of bone marrow stem cells in the uterine cavity. Endometrial growth and~     improved vascularity has been observed by ultrasound follow-up and Doppler study of~     endometrial blood flow. Endometrial regeneration has been enough to support pregnancy through~     successful IVF trial.~      The investigators have succeeded in previous work to isolate MSC from placental tissue and~     differentiate it to endometrium-like cells. The investigators compared the differentiation~     ability of placental derived mesenchymal stem cells (MSC) and Wharton Jelly derived MSC to~     differentiate to endometrium under 3 different culture conditions: endometrium conditioned~     medium (ECM), follicular fluid (FF) conditioned medium and medium containing both. The~     investigators found that placental MSC has better differentiating ability to endometrium~     especially under culture conditions containing both ECM and FF as evidenced by prominent~     appearance of glandular pattern and expression of progesterone receptors in differentiated~     cells.~      Therefore the investigators need to direct this study and test the effect of placental~     derived MSC in improving implantation rates in patients with recurrent implantation failure,~     unresponsive endometrium to ovulation induction drugs or with endometrial atrophy or advanced~     maternal age planning for ICSI trial.~      Patients and Methods:~      60 patients attending Kasr El-Aini assisted reproduction unit and private IVF center will be~     randomized to three groups by computer generated programs:~      The first group, patients randomized to receive differentiated stem cell therapy:~      After ovum pick-up, MSC differentiated to endometrium is deposited in the uterine cavity~     through an IUI catheter. Embryo transfer will be done at day 5 at the blastocyst stage to~     allow enough time for endometrial regeneration and increased endometrial receptivity.~      The second group, patients randomized to receive undifferentiated stem cell therapy:~      Immediately postmenstrual undifferentiated MSC is deposited in the uterine cavity through an~     IUI catheter to allow enough time for the MSC to differentiate as it needs 7-10 days for~     differentiation. Ovum pick-up will be done as usual while all other steps will be the same~     including embryo transfer which will be done at day 5.~      The third group, control group:~      Patients are randomized to receive no stem cell therapy; All ICSI steps from ovulation~     induction protocol to embryo transfer conditions will be the same for all groups.~      Informed consent will be taken from the patients after detailed explanation of all steps of~     the procedure.~   "
146482|NCT01649739|"~     Patients with pulmonary arterial hypertension (PAH) suffer from breathlessness, poor quality~     of life and inability to function, despite medical therapy Current consensus states that~     combination therapy with different classes of PAH-specific therapy is likely to bring~     additional benefit to PAH patients. In this study we plan to study how exercise performance~     changes when the phosphodiesterase inhibitor vardenafil is added to patients who remain~     symptomatic from PAH when treated with inhaled iloprost.~      Following baseline assessment, all Patients will start vardenafil 10 mg bid. If the drug is~     tolerated by the patients, after a two week period, up titration to 20 mg bid will be~     permitted, at the discretion of the investigators.~      According to treatment protocol up titration will be done carefully and whenever side effects~     will be reported up titration will be stopped or dosage will be decreased or stopped~     according to the investigator judgment.~      Systemic BP will be measured at baseline assessment. The patient will attend the clinic for~     the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg.~      Systemic BP will be measured at baseline assessment. The patient will attend the clinic for~     the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg. A fall~     in SBP of>30 mmHg will be considered significant or any smaller value at the discretion of~     the investigator. BP will be measured according to the following protocol.~      Pre-dose Immediately before administration of vardenafil. This will be timed approximately~     one hour prior to the next planned dose of iloprost.~      Pre-inhalation One hour post vardenafil dose, immediately prior to iloprost inhalation.~      Post-inhalation Immediately following completion of iloprost inhalation and every fifteen~     minutes for one hour.~      Prior to discharge Two hours following the iloprost.~      Later monitoring At all follow-up visits, BP will be measured.~      This is an open-label study to evaluate the safety and efficacy of adding higher doses of~     vardenafil to inhaled iloprost over 3 months.~   "
146483|NCT01649726|"~     Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem~     reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous~     breathing is established the apnea test (according to the American Academy of Neurology's~     Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and~     cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some~     data suggest modifying the apnea test : replace the ventilator switching off with continuous~     positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP)~     increased the level of lung harvest but they were not sufficient because these studies were~     monocentric, non randomized and with little patients,. That why the aim of the present study~     is to compare the standard strategy and CPAP strategy with a prospective, multicenter,~     randomized study.~   "
146484|NCT01649713|"~     This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for~     injection (trivalent, seasonal influenza vaccine, active ingredient content: 15~     μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single~     intramuscular injection of Fluval AB suspension for injection, as measured by~     haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of~     adverse events) of a single intramuscular injection of Fluval AB suspension for injection.~   "
146485|NCT01649700|"~     The study is to investigate the efficacy and safety of autologous transplantation of~     adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain~     injury.~   "
146486|NCT01649687|"~     The study is to investigate the efficacy and safety of allogenous transplantation of~     adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.~   "
146487|NCT01649674|"~     The purpose of this study is to to compare two bowel preparation regimens of patients who~     will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient~     satisfaction.~   "
146488|NCT01649661|"~     The purpose of this study is to learn about how a woman's health history influences what a~     normal breast looks like on an MRI. The investigators also want to learn about how the amount~     of different natural hormones a woman has affects how the breast looks on an MRI. The~     investigator's hope is that this will help to find women at a high-risk of breast cancer.~   "
146489|NCT01649648|"~     This is a pilot study to test feasibility and safety of collection, preparation and infusion~     of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby~     is born with signs of brain injury. The cord blood used is fresh (not frozen and then~     thawed).~   "
146490|NCT01649635|"~     Primary Objective:~      - To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3~     neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.~      Secondary Objectives:~        -  PSA response rate;~        -  Descriptive assessment of CTC (circulating Tumor Cells);~        -  Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the~          treatment period;~        -  Description of the Health Quality of Life of the patients;~        -  Incidence of adverse events.~   "
146491|NCT01649622|"~     The goal of this clinical research study is to learn if bendamustine can help to control~     Acute Lymphoblastic Leukemia/Lymphoma (ALL). The safety of this drug will also be studied.~      Bendamustine is designed to damage and destroy the DNA of cancer cells, which may cause them~     to die.~   "
146492|NCT01649609|"~     BK virus infections after kidney transplant are increasing and can result in damage to the~     transplanted kidney. Currently, the universally accepted treatment is to decrease the~     strength of the antirejection medications but it is unclear what medications should be~     lowered and to what extent. The investigators propose to perform a study with patients who~     have BK virus detected in their blood during routine screening that appears to be increasing.~     The investigators will use two different strategies that involve different combinations of~     standard anti-rejection medications at lower dosages. Patients will be assigned to one of the~     two groups in a random manner across the two hospitals participating in the study. Patients~     will be followed for at least a year to determine if one strategy was more effective than the~     other in preventing an increase in the number of viruses in the blood stream and whether~     either one was more effective in reducing the negative impact of the infection on the~     functioning of the transplanted kidney.~   "
146493|NCT01649596|"~     The purpose of this proposed study is to evaluate a normothermia protocol that includes~     preoperative warming and standard intra operative temperature management in patients~     undergoing general surgery.~   "
146494|NCT01649583|"~     The purpose of this study is to see if use of a device called the Jaw Dynasplint® System can~     be used during and immediately after cancer treatment. The Dynasplint® is a stretching device~     that is used to treat joint stiffness and limited range of motion in the jaw. The device is~     currently approved for treatment of trismus once it has developed. This study will~     investigate the use of the device during and immediately after cancer treatment to prevent~     trismus.~   "
146495|NCT01649570|"~     This trial is conducted in Japan. The aim of this trial is to investigate the safety and~     efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes~     treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.~   "
146496|NCT01649557|"~     This will be a multicenter, 52 week, open label study to assess the safety and tolerability~     of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study~     will be conducted on an outpatient basis. Enrollment into the study will be drawn from~     eligible subjects who have completed participation in Study 331-07- 203 and who, in the~     investigator's judgment, would benefit from continued treatment with oral OPC-34712.~   "
146497|NCT01649544|"~     In pre-operative cardiac surgery, 30 to 40% of patients with mitral valvulopathy have had~     episodes of paroxysmal atrial fibrillation (PAF) or are in permanent or chronic atrial~     fibrillation (CAF). According to the 1999 PMSI data, close to 4000 mitral valve interventions~     were performed in France, in other words, more than 1000 patients present with this condition~     annually; despite a surgical correction of their valvulopathy, patients presenting with a~     pre-operative chronic atrial fibrillation remain in fibrillation following surgery despite~     treatment with anti-arrhythmic agents associated or not with a cardioversion. Thus, the~     survival rate without AF recurrence is 10% at 1 year and 5% at 2 years in patients with AF~     prior to surgery; on the other hand, patients in sinus rhythm at the time of surgery and~     without an antecedent of AF exhibit an incidence of no AF of 90% and 74% at 1 and 2 years,~     respectively. It has also been shown in numerous studies that the long-term morbidity in~     patients with atrial valve surgery is higher in those with AF.~      For more than 10 years, radio-frequency techniques using the endocavitary approach have shown~     a greater efficacy in maintaining sinus rhythm than drug therapy even though the techniques~     are invasive. These radio-frequency techniques were developed and tested during mitral~     surgery, but, to the investigators knowledge, there is only one randomized study that was~     carried out in a population with permanent AF using radio-frequency technique via the~     endocardial approach. Maintenance of sinus rhythm was obtained in only 44.4% of patients~     versus 4.5% in the control group; these results are not in accordance with the published~     prospective and retrospective registries using the technique peri-operatively. The principal~     problem of this study is the absence of medical treatment in the control group. In addition,~     the use of the radio-frequency technique requires an atriotomy resulting in a prolonged~     surgical time, which increases the peri-operative morbidity.~      Other simpler ablation techniques have been developed, such as the one using ultrasound. In~     comparison with the radio-frequency method, this latter technique presents numerous~     advantages including the absence of an atriotomy due to the fact that the epicardial pathway~     is used, a short procedure time (11 min on average), excellent reproducibility, the~     transmural character of the lesions, along with the simplicity of application. There is not,~     to the investigators knowledge, a randomized study comparing the peri-operative ultrasound~     technique (EPICOR) in mitral valve surgery with the conservative reference treatment, notably~     mitral valve surgery coupled with long-term amiodarone treatment. In effect, while amiodarone~     is the most efficacious anti-arrhythmic agent in the long-term, this drug is associated with~     a high percentage of significant side effects, close to 20% at 2 years. The only available~     results using the ultrasound technique are the registries pertaining to the follow-up of~     patients undergoing cardiac mitral or aortic surgery, with an antecedent of AF. The results~     appear to be encouraging with 85% of cases maintained in sinus rhythm at 12 months in the~     most recent studies. In this clinical context, a French multi-centric registry evaluated the~     peri-operative treatment of AF with all of the proposed techniques (cryotherapy,~     radio-frequency, and ultrasound). The percentage of maintenance of sinus rhythm appears to be~     lower than in the historical registries, at the level of 60%, but the techniques used in this~     registry were multiple even if 50% of patients were treated with ultrasound; in addition,~     there was no randomization and follow-up was only for 6 months.~   "
146498|NCT01649531|"~     The aim of the present study is to test whether there is a difference in the marginal bone~     level change between implants with and without cantilevers.~   "
146499|NCT01649518|"~     Osteoarthritis is the most common affection of joints worldwide. Multiple international~     guidelines on the approach and treatment of knee osteoarthritis are available. Nevertheless~     there seems to be a gap between usual care and the preferred one.~      A vigorous set of evidence-based quality indicators on osteoarthritis diagnosis and therapy~     was developed by a multidisciplinary expert team. This project aims to map usual care and to~     explore the gaps between usual care and international guidelines in a second stage. This will~     enable us to develop a tightly targeted quality improvement intervention later on.~   "
146500|NCT01649505|"~     The purpose of this study is to investigate the efficacy of an alternative surgical technique~     and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a~     build-up of clear bodily fluids in a place on the body where tissue has been removed by~     surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days~     after surgery, after the drainage tubes have been removed. The breast area involved in the~     surgery may have a spot that's swollen and feels like there is liquid under the skin~   "
146501|NCT01649492|"~     The goal of this study is to evaluate the actual potential for in vivo pineapple juice~     inhibition with CYP2C9 substrates in human volunteers with use of diclofenac as a marker of~     CYP2C9 activity.~   "
146502|NCT01649479|"~     The main objective of this study is to estimate the lifetime prevalence of major psychiatric~     disorders (axis I DSM-IV; Diagnostic and Statistical Manual of Mental Disorders, version IV)~     in a large sample of patients with developed clinical signs of pure obstetrical~     antiphospholipid syndrome (suspected APS).~   "
146503|NCT01649466|"~     This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin~     add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate~     glycemic control on their current sulfonylurea monotherapy to give treating physicians a~     guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is~     not sufficient to reach glycemic control.~   "
146504|NCT01649453|"~     The study prospectively assesses the change in cancer-specific clinical decisions and~     outcomes before and after physicians received results from the Pathwork® Tissue of Origin~     (TOO) Test for patients whose primary site of cancer origin is uncertain.~   "
146521|NCT01649206|"~     Percutaneous radiofrequency thermal ablation (RTA) was reported as an effective tool for the~     management of thyroid nodules (TNs). This study aims to validate RTA as a valid approach for~     patients with compressive TNs for whom surgery is contraindicated or refused. Two groups of~     subjects with TNs (one group to treat with RTA and a matched untreated control group) will be~     evaluated in term of TN volume, thyroid hormones and clinical symptoms.~   "
146574|NCT01648504|"~     The investigators will attempt to improve the patient experience before colonoscopy. The~     investigators will provide an in-office ipad video series and an electronic web guide to help~     patients learn all the best ways to prepare for colonoscopy. The investigators will then~     follow the patients who receive this eGuide to colonoscopy and observe whether or not they~     enjoyed the additional access to information from their providers, and will monitor whether~     or not they were better prepared for their colonoscopy.~   "
146505|NCT01649440|"~     The occurrence of sepsis and its relevant multiple organ dysfunction remain a major problem~     in intensive care units with high morbidity and mortality. The differentiation between~     non-infectious and infectious etiologies, severity and organ function evaluation, and~     prognostic assessment are all challenging in routine clinical practice. Many biomarkers have~     been suggested for these purpose; however sensitivity and specificity even of high-ranking~     biomarkers still remain insufficient. Recently, metabolic profiling has attracted interest~     for biomarker discovery. In this study, LC-MS/MS will be perform to identify serum metabolic~     biomarkers for differentiation of SIRS/sepsis, severity and organ function evaluation, and~     prognostic assessment among 65 patients. The investigators enrolled 35 patients who were~     diagnosed with sepsis, 15 patients who were diagnosed with SIRS, and 15 normal patients.~     Moreover, the sepsis were further divided into sepsis, severe sepsis, and sepsis patients~     before death. Small metabolites that were present in patient serum samples were measured by~     LC-MS/MS techniques and analyzed using multivariate statistical methods, such as Principal~     Component Analysis (PCA), Partial Least Squares-Discriminant Analysis (PLS-DA), and~     Orthogonal Partial Least Squares Discriminant Analysis. Based on the multivariate statistical~     analysis above, the investigators could distinguish sepsis from normal and SIRS; distinguish~     the difference among sepsis, severe sepsis and death. We hypothesis that some metabolites as~     identified in this study are promising biomarker candidates in the field of sepsis diagnosis~     and treatment.~   "
146506|NCT01649427|"~     The purpose of this study is to investigate if Tacrolimus Hexal® has similar pharmacokinetic~     properties compared to Prograf® in de novo renal transplant patients and whether the~     comparable exposure results in similar renal function.~   "
146507|NCT01649401|"~     The main objective of this study is to determine whether the use of the PARI LC Sprint Sp~     nebulizer in the treatment of asthma in children under 36 months reduces the duration of~     hospitalization.~   "
146508|NCT01649388|"~     This study involves the use of an enriched hematopoetic stem cell infusion (stem cells,~     produced by the bone marrow) from the same donor who provided the original kidney transplant.~     This kidney transplant may have taken place months to years previously.~   "
146509|NCT01649375|"~     This study will assess the efficacy and safety of secukinumab in patients with active~     ankylosing spondylitis who are tolerant to or have had an inadequate response to NSAIDs,~     DMARDs and / or TNFα inhibitor~   "
146510|NCT01649362|"~     The objective of this study is to evaluate the efficacy of an oral stimulation program on the~     length of the transition period in preterm infants (primary outcome), the length of hospital~     stay and the breastfeeding rates at discharge (secondary outcomes).~   "
146511|NCT01649349|"~     The purpose of this studyis to assess the feasibility and safety of novel designed two-piece~     nasogastric tube.~   "
146512|NCT01649336|"~     This is a Phase 1 study during which patients with platinum-resistant epithelial ovarian,~     fallopian tube or primary peritoneal cancer will receive investigational study drug MEK162~     and paclitaxel. Patients will receive increasing doses of study drug in combination with~     paclitaxel in order to achieve the highest dose of study drug possible that will not cause~     unacceptable side effects. Patients will be followed to see what side effects the combination~     causes and what effectiveness the combination has, if any, in treating the cancer.~     Approximately 36 patients from the US will be enrolled in this study.~   "
146513|NCT01649310|"~     The whole body vibration offers better treatment adherence among the elderly, minimizing~     effort and additional stress to the cardiovascular system and skeletal muscles compared to~     conventional exercise programs.~      Hypothesis: Patients with COPD undergoing a training program on the whole body vibration show~     better performance in the 6MWT and improvement in muscle strength.~   "
146514|NCT01649297|"~     The aim of this study is to investigate the efficacy and safety of two doses (high and low)~     of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus~     (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a~     twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose~     once daily or split vs. low dose once daily or split). This is done to evaluate whether a~     twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once~     daily dosing when given on top of metformin background therapy.~   "
146515|NCT01649284|"~     This is an open-label, multi-center, single-arm trial, designed to provide early access to~     afatinib and to provide additional information on the safety and efficacy of afatinib in~     advanced NSCLC patients who harbor an EGFR mutation.~   "
146516|NCT01649271|"~     The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in~     combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the~     efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2~     overexpressing metastatic breast cancer.~   "
146517|NCT01649258|"~     This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal~     system work in preventing nausea and vomiting in patients with breast cancer undergoing~     chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients~     treated with chemotherapy~   "
146518|NCT01649245|"~     It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant~     interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in~     treatment of Egyptian patients with chronic hepatitis C for 48 weeks.~      hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end of~     treatment, as well as 24 weeks after therapy is completed.~   "
146519|NCT01649232|"~     In the present study the aim is to examine whether transcranial direct-current stimulation~     (tDCS) generated excitability changes and induce modifications of functional cortical~     architecture in Attention Deficit Hyperactivity Disorder (ADHD) patients. To achieve this,~     the investigators used an event-related potential (ERP) analysis based on 20 channel EEG~     recordings in ADHD subjects before and after bipolar tDCS-anode stimulation over F3/F4 or~     T5/T6 or P4/P3, during resting state and measure clinical scores and visual CPT tasks~     changes. Time courses and topography of independent component visual ERPs were compared~     before and after tDCS.~   "
146520|NCT01649219|"~     Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and~     2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom~     impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.~   "
146522|NCT01649193|"~     The purpose of this study is to determine the important change in the Short Physical~     Performance Battery (SPPB) when used in patients with lung disease. The SPPB is a simple~     physical test that measures balance and the functioning of the legs. It has been widely used~     in healthy elderly populations and predicts hospital admission and the onset of disability.~     The SPPB has not previously been used in patients with lung disease, and it is not clear what~     change in this test is considered meaningful and worthwhile by patients or doctors (the~     minimal clinically important difference: MID). Knowing what the MID for the SPPB will allow~     researchers and doctors to evaluate the effectiveness of current and new treatments, and to~     detect improvement or deterioration in the condition of patients.~   "
146523|NCT01649180|"~     The purpose of this study is to see how well the study drug, axitinib, helps control renal~     (kidney) cancer that has come back (recurrent) or spread (metastatic). Patients must have~     already been treated as a participant in a clinical trial with sunitinib, sorafenib,~     pazopanib or placebo (sugar pill) after their initial surgery.~      This study will examine the effect of adjuvant tyrosine kinase inhibition (TKI) therapy~     (sorafenib, sunitinib or pazopanib) on subsequent exposure to TKI with axitinib in the~     first-line recurrent or metastatic setting.~   "
146524|NCT01649167|"~     Background: Obesity in pregnancy is increasing and is a risk factor for metabolic pathology~     such as preeclampsia. Leptin is an adipokine which has a direct relationship to obesity.~      Aim: to measure leptin in lean, obese and diabetic pregnant women at three months intervals~     throughout their pregnancies.~      Methods: Pregnant women were recruited in the 1st trimester of pregnancy, and three groups~     were formed: a) with pregestational Body Mass Index (BMI) less than 25 kg/m2, b) BMI higher~     than 25 kg/m2 and c) with Gestational Diabetes Mellitus (GDM). Serum levels of leptin were~     measured with radioimmunoassay (RIA) technique.~   "
146525|NCT01649154|"~     The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery.~     The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative~     blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of~     post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to~     traditional dissection in a prospective randomized trial of total thyroidectomy procedures,~     for benign disease.~   "
146526|NCT01649141|"~     This effectiveness study is being conducted to determine whether Trauma-Focused Cognitive~     Therapy (TF-CBT), a treatment model developed in specialty clinics by experts in the~     treatment of child sexual abuse, can be effectively transported to a state-contracted~     community mental health agency in the state of Delaware and used effectively by clinicians~     with little prior TF-CBT experience. The sample is comprised of youths receiving public~     mental health services and with diverse trauma histories.~   "
146527|NCT01649128|"~     For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators~     established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of~     Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down~     syndrome screening.~   "
146528|NCT01649115|"~     The purpose of this study is to evaluate the effectiveness of the Healthy Lifestyles Passport~     Program (HLPP) in preventing infant and childhood obesity. It is hypothesized that the~     participants in the intervention arm will exhibit less excessive weight-for-length gain from~     4- to 6-months of age. In 2-years and 5-years, it is predicted that the participants in the~     intervention arm will yield lower Body Mass Index (BMI) z-scores than the participants in the~     control arm, who receive usual care.~   "
146529|NCT01649102|"~     The trial aims to compare the performance of two tunneled cuffed catheters (TCC) in chronic~     hemodialysis patients. The design of the catheter may affect the propensity for thrombosis~     and hence intraluminal infection, as well the percentage of recirculation and hence the~     efficiency of dialysis.~   "
146530|NCT01649089|"~     This clinical trial studies the physical function and quality-of-life before and after~     surgery in patients with stage I cervical cancer. Studying quality-of-life in patients~     undergoing surgery for cervical cancer may help determine the intermediate-term and long-term~     effects of surgery.~   "
146531|NCT01649063|"~     Dystocia is the most common indication for primary cesarean section. The most common cause of~     dystocia is uterine dysfunction. In all cephalopelvic disproportion studies, more attention~     is usually paid on fetus and pelvic rather than on the role of uterine contraction in~     delivery. So we decided to determine the relationship between dystocia and uterine~     contraction patterns.~   "
146532|NCT01649050|"~     To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due~     to multiple sclerosis~   "
146533|NCT01649037|"~     All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or~     during hospitalization will be included in the study.~      The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory~     tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and liver~     histology, when available.~   "
146534|NCT01649024|"~     The study is designed to define the immunologic and clinical activity of Tremelimumab in~     patients with advanced mesothelioma.~   "
146535|NCT01649011|"~     The purpose of the study is to validate in Mexico a spanish translation of the 2.1a Oswestry~     Disability Index (ODI) version in patients with low back pain.~      Internal consistency, reproducibility and reliability will be addressed scoring the results~     of the translated version at two time frames. A previously spanish validated translation of~     the of the Roland Morris Disability Questionnaire (RMDQ) will be used to compare and evaluate~     both versions.~   "
146546|NCT01648868|"~     In this protocol we aim to use rTMS to better characterize STS role in normal and abnormal~     social cognition. With that purpose, we will measure the effect of inhibitory and excitatory~     rTMS on the fixation time on social scenes (using eye-tracking methodology) or on the ability~     to recognize human voice/sounds.~   "
146575|NCT01648491|"~     Determine safety and effectiveness of the technique using autologous stem cells in the~     treatment of urinary incontinence in one male subject.~   "
146586|NCT01648257|"~     This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods)~     in healthy adult subjects. During each period, subjects will receive a single dose of~     GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8~     days) and safety assessments will be performed. Each period will be separated by a washout~     period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose~     of study drug.~   "
146536|NCT01648998|"~     Stimulating the mineralocorticoid receptor (MR) may restore a disturbed balance as seen in~     depression. In this double-blind, randomized, placebo-controlled trial the investigators will~     test the effects of a single dose (500mg) fludrocortisone, an MR-agonist, on the information~     processing in healthy female volunteers (N = 2x20).~      The investigators want to investigate whether the acute administration of fludrocortisone~     (FC) in healthy females enhances the appraisal of emotional information related to~     depression, hypothesizing that:~        -  FC relative to placebo selectively improves the recognition of happy and fearful faces:~          resulting in more correct responses and faster RTs.~        -  FC induces a bias towards more positive self-description and an improved memory for~          positive information.~      Female participants were selected because the haplotype MRI180V is related to depression~     vulnerability in women, not in men. If the effects of fludrocortisone are comparable to the~     effects of antidepressants on the same tests and the same population, it might be a first~     indication that fludrocortisone may function as an antidepressant.~   "
146537|NCT01648985|"~     In acute stroke patients about 20 % have known diabetes. There is a doubled risk of recurrent~     stroke in diabetic patients. It has been shown that antiplatelet drugs are not as effective~     in diabetic patients as in non-diabetic patients. In acute stroke patients around 80 % have~     impaired glucose tolerance, which will improve after one month till about 60 %.~      This study includes acute patients with minor stroke or TIA. They are followed up at one and~     six months and then at every six months for at least four years. The investigators perform an~     OGTT and haemostatic tests within the first days after onset and then at one month. Blood~     pressure, metabolic parameters, bodyweight, physical activity and diet are collected at each~     visit. The investigators give the patients information about lifestyle changes as needed.~      As part of the study there is an interventional study, Medicine Yoga, an open randomized~     controlled study. Patients are randomized to 16 sessions of Yoga under professional~     instructions and a CD for home training or controls.~      The aims of this study are to investigate glucose tolerance in acute stroke and TIA patients,~     and its relation to the different haemostatic variables. The importance of glucose tolerance,~     haemostatic variables and other risk factors (blood pressure, lipids, BMI,) on cardiovascular~     events will be investigated and the possibility to affect these risk factors by lifestyle~     changes and Yoga. The effect of different antiplatelet drugs will be investigated in relation~     to glucose tolerance.~   "
146538|NCT01648972|"~     After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this~     time patients are often unable to eat and drink, and do not pass any flatus or stool. Though~     this resolves within a few days for most, there are a significant number (around 30%) who go~     on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It~     has been clearly shown that this group of patients have worse health outcomes and spend a~     longer time in hospital.~      The aim of this study is to trial a drug - gastrografin - in the management of prolonged~     postoperative ileus. Gastrografin is safe, economical, readily available, and has been used~     with great success in the similar condition of bowel obstruction. It is predicted that~     gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording~     affected patients a better outcome from surgery.~   "
146539|NCT01648959|"~     Various parts of the brain are sensitive to various anesthetics.We like to study the effect~     of dexmedetomidine on the different parts of the brain in patients who are coming for DBS~     electrode removal under sedation.~   "
146540|NCT01648946|"~     Blood transfusion in critical ill patients has been associated to several complications and~     worse outcome. Particularly in oncologic patients, red blood cell transfusion has been~     investigated as a factor of worse outcome and cancer recurrence due impairment of cellular~     immunity. Although red blood cell transfusion has decreased in worldwide clinical practice,~     this issue still remains a matter of controversy in oncologic patients. There are no~     prospective studies comparing outcomes between restrictive or liberal blood transfusion~     strategy in oncologic critical patients. This study is a prospective and randomized study~     comparing clinical outcomes between two strategies of transfusion in oncologic critical~     patients - liberal or restrictive.~   "
146541|NCT01648933|"~     The study aims at assessing diagnostic and therapeutic impact of Rubidium-82 PET in cardiac~     sarcoidosis.~   "
146542|NCT01648920|"~     Objective: To explore the utility of Fractional Exhaled Nitric Oxide (FeNO) compared with~     Methacholine Challenge (MCC) testing in assessing patients with suspected but undiagnosed~     asthma~      Number of participants: Approximately 50 subjects will be enrolled~      Reference product: NIOX MINO® Instrument (09-1100)~      Performance assessments: FeNO measurements will be performed according to the Perform FeNO~     Measurement guidelines on page 7 of the NIOX MINO® User Manual. MCC testing will be~     performed according to the ATS guidelines and the allergy and asthma specialists procedure~     for conducting MCC tests~      Safety assessments: The Investigator is responsible for the detection, reporting, and~     documentation of events meeting the definition of an Adverse Event (AE) and/or Serious~     Injuries as provided in this clinical investigation plan from the time that informed consent~     has been provided and during the study period~      Criteria for evaluations: This is an exploratory study and there are currently no plans for a~     formal statistical analysis. Information gained from this study may used to design and power~     subsequent studies in patients with suspected but undiagnosed asthma. Information collected~     will be summarized in a clinical study report~   "
146543|NCT01648907|"~     This study is a large national multicenter, longitudinal, prospective follow-up of patients~     presenting with early inflammatory back pain in order to set up a database to facilitate~     several investigations on diagnosis, prognosis, epidemiology, pathogenesis and~     medico-economics in the field of early inflammatory back pain and spondyloarthritis~   "
146544|NCT01648894|"~     At the end of the neoadjuvant radiochemotherapy, patients are seen by their surgeon to~     planify the surgery. During this visit, the study will be explained them and their consent~     obtained. They will then be randomized between the two groups 7 weeks vs. 11 weeks. Patients~     were reviewed 15 days before surgery and at 1 and 3 months after surgery. Participation in~     this study does not change treatment, investigations and consultations usually necessary for~     management of rectal cancer. The objective is to improve the pathological complete response~     rate of the rectal cancer.~   "
146545|NCT01648881|"~     Patients with dissection of the descending aorta will be followed up according to a precise~     timeline.~   "
146547|NCT01648855|"~     Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and~     neonatal morbidity and mortality worldwide. Imbalance between circulating angiogenic and~     antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of~     preeclampsia. Patients with preeclampsia have a higher circulating concentration of~     antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR-~     1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and~     a lower maternal circulating concentration of free angiogenic factors (ie, vascular~     endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a~     normal pregnancy. Bronchopulmonary dysplasia is the main respiratory sequelae of preterm~     birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent~     studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in~     the number of small arteries and on abnormal distribution of vessels within the distal lungs.~     This is associated with reduced lung VEGF expression. The main objective of this~     population-based study, ie in intra uterine growth restricted preterm babies born before 30~     weeks of gestational age, was to examine whether levels of sFlt1 at birth in maternal and~     umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD.~   "
146548|NCT01648842|"~     Hypothesis : Vitamin D serum concentration is decreased in the first trimester in pregnant~     women who will develop preeclampsia in the second or third trimester compare to a control~     group Primary purpose : To determine the vitamin D status in the first trimester in a large~     population of french pregnant women in order to evaluate the importance of the vitamin D~     deficiency in France and correlate this deficiency with preeclampsia~   "
146549|NCT01648829|"~     Levels of platelet reactivity in patients on Dual Antiplatelet Therapy (DAPT) can be~     influenced by concomitant treatment with medications (i.e. statins) that inhibit the CYP3A4~     system involved in the activation of clopidogrel. Atorvastatin and simvastatin are~     metabolized by CYP3A4. Pitavastatin, unlike other statins, is little metabolized, most of the~     dose being excreted unchanged in bile, and biotransformation through the cytochrome P450~     system is minimal. Indeed, pitavastatin's cyclopropyl group diverts the drug away from~     metabolism by CYP3A4 and allows only a small amount of clinically insignificant metabolism by~     CYP2C9.~      The primary objective of this study is to compare the pharmacodynamic effects of a~     CYP3A4-metabolized statin (atorvastatin) versus a non-CYP3A4-metabolized statin~     (pitavastatin) in patients showing high platelet reactivity while on DAPT.~   "
146550|NCT01648816|"~     The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a~     higher maternal morbidity and mortality, and also with pervasive effects on the emotional,~     cognitive and behavioral development of the infant.~      Stressful life events, socio-demographic and obstetrical risk factors have been associated~     with the risk of PPD. Genetics risk factors of PPD have also been identified. We are~     presently studying for the first time how maternal stressors may interact with genetic~     factors to increase the risk of PPD (Gene x Environment interaction).~   "
146551|NCT01648803|"~     The purpose of this study is to measure motor fluctuations and dyskinesias in patients with~     Parkinson's disease using movement sensors (accelerometers and gyroscopes) to determine if~     this is a feasible measure to use in addition to self report, and eventually the goal will be~     to replace self report with a more reliable measure such as movement sensors.~   "
146552|NCT01648790|"~     The purpose of this study is to evaluate the amount of drug available in the body when given~     to healthy participants as two different formulations with or without a meal. In addition,~     this study will evaluate how much of the drug gets into the blood stream and how long the~     body takes to get rid of it. Information about any side effects that may occur will also be~     collected. Each participant will receive a total of five different treatments. Each treatment~     is given by mouth, once a day. The treatment period lasts for five consecutive days.~   "
146553|NCT01648777|"~     Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase~     their mortality. While chest physical therapy plays a crucial role to prevent postoperative~     pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical~     therapy. The continuous local anesthetic infusion by multiperforated catheter decreases~     sternum pain. Because of this optimal pain management, early chest physical therapy could be~     more efficient and could contribute to decrease the rate of pneumonia.~      The aim of this study is to test if management of sternotomy pain using continuous local~     anesthetic infusion by multiperforated catheter may contribute to decrease the rate of~     perioperative pneumonia.~   "
146554|NCT01648764|"~     The purpose of this study is to evaluate two different dosing regimens of LY2334737 in~     participants with cancer that is advanced and/or has spread to other parts of the body.~     Information about side effects will be collected.~   "
146555|NCT01648751|"~     This is a randomized controlled trial in which women with symptomatic mild pelvic organ~     prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus~     placebo to see if a combined approach to treatment leads to improvement in clinical outcomes.~     The investigators predict that PFPT in combination with vaginal estrogen will lead to~     decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker~     data.~   "
146556|NCT01648738|"~     The purpose of this study is to determine whether an intensive 5 days long multidisciplinary~     program (including spa therapy, exercises and patients'education) is more effective regarding~     return to work than usual care in subacute and chronic low back pain for people in sick leave~     from 4 to 24 weeks duration, and for which an extension of sick leave is considered~   "
146557|NCT01648725|"~     Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what~     extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.~      A particular aspect of this study is that induction is provided by a closed-loop system which~     delivers propofol according to bispectral index.~   "
146571|NCT01648543|"~     Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best~     method of lumbar sympathetic ganglion block is not established. The investigators would~     compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's~     entry point is 7~7.5cm from midline of spinous process of lumbar spine. The other is angular~     method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison~     modified Reid method with angular method would be helpful for finding best method of lumbar~     sympathetic ganglion block.~   "
146558|NCT01648712|"~     Optimal anticoagulation is mandatory during CPB in order to avoid hemostatic system~     activation. Platelet dysfunction is commonly observed after procedures performed under~     cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and bleeding~     in the postoperative period.~      Coating of the surface has been shown to diminish these effects.Biocompatible surfaces,~     extracorporeal circulation technologies mimic critical characteristics of the vascular~     endothelium to provide thromboresistance and enhanced blood compatibility. Recently, a new~     physiologic non heparin coating with different functional aspects was developed as an~     alternative to heparin based biological coatings. This bio-passive Hydrophilic Polymer~     Coating Without Heparin (BalanceTM Bio-Passive surface) and pediatric oxygenation system~     (Affinity PixieTM Oxygenation System), is designed to mimic the natural interfaces of blood.~     The aim of this study is to compare the influence of a Balance - coated CPB system in~     pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation~     and hemostatic activation.~   "
146559|NCT01648699|"~     The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral~     System (OROS) hydromorphone using standardized conversion from prior opioid therapy among~     participants with cancer pain.~   "
146560|NCT01648686|"~     The purpose of this study is to determine whether the oral alendronate treatment of~     post-menopausal osteoporosis could be a risk factor for jaw bone healing after dental~     extraction.~   "
146561|NCT01648673|"~     The main purpose of this pilot study is to evaluate an impact of JHI CR Platform on patient~     referral, recruitment and retention rates and overall patient satisfaction in cardiovascular~     rehabilitation programs at the HFHS.~   "
146562|NCT01648660|"~     The primary objective of LUTEGA 2 is it to determine the long term effect (about 2 more years~     after LUTEGA 1, NCT00763659) of the supplementation with a fixed combination of~     lutein/zeaxanthin and omega-3- fatty acids in two different dosages on the optical density~     (OD) of macular pigment in patients with non- exudative age related maculopathy. The dosage~     groups are crossed after LUTEGA 1.~   "
146563|NCT01648647|"~     Copeptin is accepted as a marker of stress. We want to evaluate the preoperative and early~     postoperative copeptin leavens in patients undergoing different aortic valve procedures~   "
146564|NCT01648634|"~     The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the~     development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15~     year-old.~   "
146565|NCT01648621|"~     Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases~     referred to as comorbidities. Often these patients require health care by a variety of health~     care professionals from services linked to hospitals and in the community. Unfortunately,~     sometimes it may be difficult for these patients to receive appropriate care in a timely~     manner resulting in a trip to the emergency department. As well, patients may benefit from~     education that enables them to recognize early signs indicating they are getting sicker and~     to self-manage their disease. Our study will examine a strategy that includes a case manager~     who will make weekly phone contact with COPD patients with comorbidity that present either to~     the emergency department or are admitted to hospital. Weekly contact will focus on teaching~     patients to recognize worsening symptoms and self-management strategies. The case manager~     will work with patients, caregivers, community health care providers and hospital specialists~     to promote communication and optimize care delivery. The investigators will examine the~     impact of our intervention on the need for emergency department visits and hospital~     admission. The investigators will also examine the impact on patients' health related quality~     of life, number of COPD exacerbations, and disease progression.~   "
146566|NCT01648608|"~     Select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy~     and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant~     chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the~     same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of~     TAC and Exemestane.~   "
146567|NCT01648595|"~     Background: There are two methods of pharmacologic and non- pharmacologic for reducing pain~     of delivery. It is necessary to be known effect of these drugs on the mother and fetus during~     labor adverse. Therefore, the purpose of this study was determination of effect of Fentanyl~     intravenously on pain severity during the active phase of labor.~   "
146568|NCT01648582|"~     The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe~     compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who~     have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM)~     (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended~     by their healthcare providers.~   "
146569|NCT01648569|"~     Although the vast majority of patients with Papillary Thyroid Microcarcinoma (PTMC) have~     excellent long-term outcomes, some patients experience tumor recurrence, either locally or,~     less frequently, as distant metastases, with some patients dying due to this disease. The~     natural course of PTMC has not always been universally accepted, thus creating controversy~     concerning the diagnosis and treatment of PTMC. Further, it is not yet possible to~     confidently identify PTMCs that would take aggressive courses if left untreated. Treatment~     recommendations range from observation alone to vigorous intervention featuring total~     thyroidectomy, prophylactic cervical lymph node dissection, and adjuvant RI ablation.~     Therefore, no consensus has yet been reached on the biological aggressiveness of PTMC or on~     which therapy is the most appropriate. Moreover, the impact of several clinicopathologic risk~     factors, including tumor size, is unclear, although patients with tumors ≤ 0.5cm in diameter~     may have a better prognosis than patients with tumors 0.5-1 cm in size.~      Most studies evaluating the proper extent of surgery for PTMC have been retrospective in~     design. A prospective, long-term, randomized study in a large number of patients, however,~     may not be feasible owing to the need for an extensive follow-up duration, the costs~     associated with such a study, and, particularly, its ethical constraints. Consequently, it is~     not currently possible to determine the prognosis of patients with PTMC or the proper~     therapeutic approach in these patients. The investigators therefore compared long-term~     outcomes after total thyroidectomy (TT: total or near-total thyroidectomy) or less than total~     thyroidectomy (LT: lobectomy or subtotal thyroidectomy) in a large cohort of patients with~     PTMC, using propensity-score matching to adjust for the uncontrolled assignment of surgical~     extent in these patients. In addition, the investigators evaluated whether tumor size, ≤ 0.5~     cm or > 0.5 cm, had a significant impact in determining the extent of surgery in patients~     with PTMC.~   "
146570|NCT01648556|"~     It is about a multicentric study prospective of more than patients' 60 years with a~     thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so~     certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO,~     the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis~     of PTI.~   "
146572|NCT01648530|"~     This is a population internet-based study to characterize migraine clinical course and impact~     on family.~   "
146576|NCT01648478|"~     Previous studies have demonstrated defects in the trafficking and translocation of GLUT4~     glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin~     resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which~     collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin.~     The extracellular domain of IRAP is cleaved and released in the bloodstream.~      Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.~      In this study the investigators seek to confirm this hypothesis by using the gold standard of~     insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.~      It is a multicenter descriptive study.~   "
146577|NCT01648465|"~     The purpose of this study is to explore the efficacy and safety of everolimus administered as~     a first-line treatment in newly-diagnosed patients with advanced or inoperable~     Gastrointestinal (GI) or pancreatic neuroendocrine tumors.~   "
146578|NCT01648452|"~     Background:~        -  Achromatopsia is an inherited condition that causes vision loss because cells in the~          retina do not work properly. It causes loss of acuity, sensitivity to light, and loss of~          color vision. There are no effective treatments for achromatopsia.~        -  Four genes currently are known to cause achromatopsia. One of these, the cyclic~          nucleotide-gated channel beta 3 (CNGB3) gene, is the cause in about 50 percent of~          people.~        -  CNTF is a natural chemical found in the body that promotes survival and function of~          nerve cells. CNTF has been shown to be effective in treating retinal disease in animals~          and can slow vision loss.~        -  CNTF has also been studied in over 250 people with retinal disease other than~          achromatopsia. In these studies, a CNTF implant was placed into the eye during a simple~          surgery. The implant releases CNTF inside the eye, near the retina. These studies~          suggested that a CNTF implant might help vision in some eye diseases.~      Objectives:~        -  To learn whether a CNTF implant is safe for people with CNGB3 achromatopsia.~        -  To learn whether CNTF can improve visual acuity or color vision, and whether it may~          reduce sensitivity to light in people with CNGB3 achromatopsia.~      Eligibility:~      You may be able to take part in this study if you:~        -  Are at least 18 years old.~        -  Test positive for mutations in the CNGB3 gene and have no mutations in another~          achromatopsia gene.~        -  Have 20/100 vision or worse in at least one eye.~        -  Are not pregnant or nursing.~      Design:~        -  To determine if you can take part, we will ask about your medical history and do a~          physical examination and an eye examination. Blood and urine samples will be taken.~        -  This study requires 11 visits to the National Eye Institute over 3 years.~        -  One visit will be for the implant surgery. The implant will be placed in one eye only.~        -  Study visits will take place 1 day after implant surgery, and again 1 week later and 1~          month, 3 months, 6 months, 1 year, 1.5 years and 3 years later. These visits will help~          us evaluate the safety and benefit of the implant on your eye.~        -  At the 3 year visit, you can choose to keep the CNTF implant in your eye, or you can~          have us remove it.~   "
146579|NCT01648348|"~     This partially randomized phase I/II trial studies the side effects and the best dose of~     anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how~     well they work in treating patients with glioblastoma multiforme that has come back.~     Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may~     find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together~     with bevacizumab may be an effective treatment for glioblastoma multiforme.~   "
146580|NCT01648335|"~     Dislocation of the glenohumeral joint of the shoulder is a common orthopedic clinical~     problem. The majority of the dislocations are anterior (about 95%) while the rest are~     posterior and inferior. After reduction of the initial dislocation, the treatment's goal is~     to prevent recurrent dislocations. In spite of treatment, the recurrence rate is 80-90% in~     the population aged 18-29. There is an age-related decrease in the recurrence rate, with the~     only 2-3% for ages 60-70. It has been calculated that 1 in 200 soldiers in the Israeli Army~     between the ages of 17 and 33 suffers from recurrent shoulder dislocations [1].~      The traditional treatment for primary (first-time) shoulder anterior dislocation has been~     immobilization of the shoulder in internal rotation in a soft dressing called universal~     shoulder immobilizer (USI) for 3-6 weeks. However, there is a lack of evidence-based~     information to demonstrate the effectiveness of this treatment. Posterior dislocations are~     immobilized in external rotation. Work presented previously in the Orthopaedic Research~     Society and more recently at the American Academy of Orthopaedic Surgeons suggests that~     immobilization of the shoulder after reduction of anterior dislocation is best in external~     rotation and not in internal rotation. MRI studies have shown that the labral tear, which is~     the hallmark of most traumatic anterior dislocations, is best reduced to its anatomical~     position when the shoulder is immobilized in external and not in internal rotation.~     Preliminary data indicates that immobilization in external rotation of the primary traumatic~     shoulder dislocations may lower the incidence of reoccurrence.~      The traditional shoulder immobilizer is a generic bandage produced by several companies. In~     the current study, the investigators will use a USI distributed by Uriel® company (Uriel~     #87), which can be modified to hold the shoulder in external rotation.~   "
146581|NCT01648322|"~     This is a randomized open label dose finding study to evaluate the efficacy and safety of~     F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.~   "
146582|NCT01648309|"~     The purpose of this study is to examine the neuropsychological effects of transvascular~     aortic valve implantation (TAVI). Patients undergoing TAVI usually suffer from congestive~     heart failure and low cardiac output which may limit their cognitive abilities. TAVI results~     in significant improvements in cardiac function and therefore may improve cognitive~     functions. However, TAVI may also be associated with stroke and may therefore have a negative~     impact on cognition. Therefore, in this study the investigators wish to perform a battery of~     standardized neuropsychological tests before and after TAVI to test the net effects of TAVI~     on cognitive performance over time.~      The investigators plan to include all patients planned to have TAVI in the study and to test~     them before, 3,7, 30 and 360 days post TAVI with a standardized battery of test.~   "
146583|NCT01648296|"~     A single center, open-label baseline controlled imaging study to designed to assess whether~     Positron Emission Tomography (PET) measurements of myocardial Fatty Acid (FA) metabolism~     performed with [18F]FluorbetaOx correlates with measurements using [11C]palmitate. This study~     involves the investigational use of a PET radioactive tracer, fluorine-18 radiolabeled fatty~     acid analog, [18F]FluorbetaOx designed to measure beta oxidation of fatty acids in the~     myocardium. The investigators propose to evaluate the feasibility of the method in heart~     failure patients with dilated non-ischemic cardiomyopathy (DCM) with or without type-2~     diabetes mellitus (T2DM) and obese subjects (Body Mass Index of ≥ 30kg/m2) with or without~     T2DM and normal healthy subjects to provide a wide range of perturbations in myocardial FA~     metabolism.~      Specific objectives include:~        1. To assess the diagnostic quality of [18F]FluorbetaOx PET images and kinetics at the~          proposed 10 millicurie (mCi) dose.~        2. To quantitatively determine the relationship between PET measurements of myocardial FA~          metabolism obtained with [18F]FluorbetaOx and those using [11C]Palmitate.~        3. To calculate human dosimetry based on the human biodistribution of [18F]FluorbetaOx.~        4. Correlate measurements of myocardial FA metabolism with changes in left ventricular~          (LV)structure and function performed on a clinically indicated echocardiography at 6-9~          months after imaging.~   "
146584|NCT01648283|"~     This research study will determine if genetic variation in CYP2B6 affects how the body~     metabolizes methadone.~   "
146585|NCT01648270|"~     The purpose of this study is to see how healthy volunteers bodies handle buprenorphine.~   "
146587|NCT01648244|"~     The primary purpose of this study is to determine whether the use of CADS by primary care~     providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care~     relative to a usual care group in terms of objective outcome measures of glycemic control~     (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of~     subjective ratings by patients.~   "
146588|NCT01648231|"~     The purpose of this study is to evaluate the comparative bioavailability of two fixed dose~     combination tablet formulations of amlodipine and losartan in healthy volunteers. Subjects~     will receive each of the following three treatments administered in a randomized three-way~     crossover design: a reference treatment consisting of a 5mg amlodipine tablet and 100mg~     losartan tablet; a fixed dose combination tablet consisting of 5mg amlodipine and 100mg~     losartan; and another fixed dose combination tablet consisting of 5mg amlodipine and 100mg~     losartan; all three treatments will be administered once orally and in a fasted state. Serial~     blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of~     amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite).~     Safety assessments will include measurements of orthostatic vital signs, electrocardiograms~     (ECG), collection of adverse events (AE) and clinical laboratory tests.~   "
146589|NCT01648218|"~     No consensus guidelines exist for management of post-transplant glucocorticoid induced~     hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety~     of insulin regimens have been proposed, including mealtime short-acting regular or analog~     insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal~     insulin alone such as glargine or detemir. However, no randomized trial has ever examined~     different insulin regimens to determine which most effectively controls post-transplant~     steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three~     commonly used insulin regimens used for managing post-transplant once-daily~     glucocorticoid-induced hyperglycemia to determine which is most effective:~        -  Group 1: Intermediate-acting (NPH) insulin at breakfast~        -  Group 2: Short-acting insulin (regular or aspart) before meals~        -  Group 3: Insulin glargine at breakfast~      Question/Hypothesis:~      Among three commonly used insulin regimens, which is most effective for managing~     post-transplant once-daily glucocorticoid-induced hyperglycemia?~   "
146590|NCT01648205|"~     The purpose of this study is to determine whether late sodium channel blockade might be~     effective in shortening the QTc interval in various LQT3 mutations and be considered as a~     safe therapeutic option for LQT3 patients.~   "
146591|NCT01648192|"~     This study is the first study of losmapimod in Japanese subjects. This study will be a~     single-center, single blind, phase I and two part study to characterize the safety,~     tolerability, pharmacokinetic and pharmacodynamic profiles in healthy Japanese volunteers~     (male and female of non-childbearing potential). Part1 will be a single dose, randomized,~     three-period, placebo-controlled and dose escalation part. Each subject will participate in 3~     dosing sessions, and receive, on separate days, three of four treatments of losmapimod 2.5,~     7.5 and 20 mg, and the matching placebo in the fasted state after overnight fast (at least 10~     hours). The design incorporates sufficient washout between treatments (at least 7 days after~     the previous administration), and is an efficient design for the study objectives. Part 2~     will be a fixed dose and placebo-controlled part. Each subject will participate in one dosing~     session, and receive losmapimod 7.5 mg or the matching placebo twice daily in the fasted~     state for 14 days. Only subjects will be blind to the sequence and dose studied. The study~     will include the placebo treatment to allow a valid evaluation of adverse events attributable~     to treatment versus those independent of treatment. Approximately 18 subjects in each part~     will receive treatments of losmapimod and/or placebo in the design. The primary objective of~     the study is to characterize the safety and tolerability of single doses and repeat doses of~     losmapimod in healthy Japanese subjects. Serial pharmacokinetic samples will be collected and~     safety assessments will be performed following each dose.~   "
146592|NCT01648179|"~     This study is an open-label, randomized, single dose, four period, balanced crossover study~     to assess in eligible healthy male or female subjects.~   "
146593|NCT01648166|"~     This is a research study about the relationship between lung cancer and environmental risk~     factors. The purpose of this study is to try to understand the effects of trace elements such~     as arsenic and chromium, as well as radon on the development of lung cancer. To do this, the~     investigators will collect information and environmental and biologic specimens from people~     who live in Appalachian Kentucky who a) have lung cancer or b) don't have lung cancer and~     will serve as control subjects. The investigators will create a specimen repository of from~     these people and their residences to compare differences in many risks factors for cancer. By~     doing this study, the investigators hope to learn why there are more lung cancers in~     Kentucky's fifth Congressional District than anywhere else in the nation.~   "
146594|NCT01648153|"~     GSK1070806 is a humanised IgG1/kappa antibody which is directed against the soluble cytokine~     interleukin-18 (IL-18). The aims of this placebo controlled study are to evaluate the~     efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1070806 in obese~     subjects with Type 2 diabetes mellitus (T2DM), and to gain a better understanding of the~     mechanism by which GSK1070806 exerts its therapeutic effects.~   "
146595|NCT01648140|"~     GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being~     developed for the treatment of chronic HCV infection. This Phase II, multicenter,~     parallel-group, randomized, dose-ranging study will assess the safety and tolerability,~     antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in~     combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100~     treatment-naïve subjects with chronic genotype 1 HCV infection.~      In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with~     genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of~     GSK2336805.~   "
146596|NCT01648127|"~     The purpose of this study is to characterize plasma and urinary concentrations of ceftaroline~     following intravenous administration of a single dose of ceftaroline 600 mg in healthy~     subjects who are normal weight, overweight, and obese.~   "
146597|NCT01648114|"~     The investigators will conduct an educational intervention for pregnant women who are~     planning to breastfeed to promote exclusive breastfeeding and to increase the duration of~     breastfeeding.~   "
146619|NCT01647828|"~     The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD)~     of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2,~     multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of~     OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously~     untreated stage IV pancreatic cancer.~   "
146598|NCT01648101|"~     The immediate release (IR) formulation of retigabine has been shown to be superior to placebo~     as adjunctive therapy in 3 adequate and well-controlled studies in subjects with~     drug-resistant partial-onset seizures (POS) who had previously failed to respond to two or~     more antiepileptic drugs (AEDs) and were still having seizures despite current treatment with~     1, 2, or 3 AEDs. However, of 1244 subjects randomly assigned to treatment in these 3 clinical~     studies, only 10 were Asian subjects and only 5 of these Asian subjects were randomly~     assigned to treatment with retigabine. Therefore, this Phase III study is being conducted to~     evaluate the efficacy, safety and tolerability, and health outcomes of retigabine, at doses~     of 900 mg/day and 600 mg/day, compared with placebo in adult Asian subjects with~     drug-resistant POS.~   "
146599|NCT01648088|"~     The presence of Staph in/on a patient who will undergo total joint replacement is a risk in~     that the patient could go on to develop infection at the surgery site after surgery. The~     purpose of this study is to evaluate if it is beneficial to to administer a questionnaire and~     obtain cultures from various body sites from patients prior to surgery and also to determine~     which body site(s) provide the best source of possible staph presence. If the pre operative~     cultures indicate staph is present, an Infectious Disease specialist will be consulted for~     standard of medical care consultation and treatment management. All patients scheduled to~     have total joint arthroplasty are eligible to participate. The research team will follow the~     study patients for 2 years after they undergo prosthetic joint implantation to monitor for~     development of prosthetic joint infection.~   "
146600|NCT01648075|"~     Probiotics are microorganisms that when administered in adequate amounts can confer health~     benefits. In vitro and clinical studies support the idea that lactobacilli have protective~     effects on oral health. A recent study in which preschoolers consumed milk drinks enriched~     with Lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits~     to children.~      The aim of this study is to evaluate the effect of daily consumption of milk beverages~     enriched with Lactobacillus rhamnosus on the incidence of caries in preschool Chilean~     children.~   "
146601|NCT01648062|"~     This randomised controlled trial assessed the efficacy of four mental imagery techniques for~     improving sleep and its related behaviour: (1) imagery focused on reducing arousal levels;~     (2) imagery incorporating implementation intentions (a strategy designed to link specified~     behaviour with the anticipated context) for sleep-related behaviour; (3) a combination of~     imagery using arousal reduction and implementation intention strategies; or (4) a condition~     where participants were asked to imagine their typical post work activities.~   "
146602|NCT01648049|"~     Insomnia and depression are two of the most prevalent mental health disorders and often~     co-occur.~      Health disparities in rural America and among African-Americans are well documented. The~     investigators propose an R34 exploratory project to test the feasibility of delivering~     high-fidelity insomnia and depression psychological services to an underserved population.~     Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat rural,~     predominantly African-American older adults who present to their primary care physician with~     co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study series (n = 10)~     focusing on treatment development/refinement and patient acceptability. In stage 2,~     feasibility will be experimentally tested with 46 participants randomized to integrated~     cognitive-behavior therapy (CBT) + usual care or to usual care only in an effectiveness pilot~     study. The treatment will combine/integrate compact CBT for insomnia (including relaxation,~     sleep restriction, and stimulus control) and for depression (including cognitive therapy and~     behavioral activation). The experimental intervention comprises delivering CBT services by~     videoconferencing to patients in primary care settings who live in rural areas. Treatment~     will be evaluated by pre, post, and follow-up self report instruments on insomnia,~     depression, and quality of life. In addition, the stage 1 pilot will use investigator~     designed quantitative and qualitative measures to evaluate critical process variables~     including patient acceptability of the video format, patient acceptability of the treatments,~     and obstacles to adherence. Depending on stage 1 data, these measures may be incorporated~     into stage 2 as well. Several innovative features of this exploratory project include:~     intervening with CBT on both disorders hoping to gain a synergy by their combined~     presentation; use of telehealth to deliver treatment to distant locations; translation of~     efficacy findings to an effectiveness trial; treatment will be delivered in the primary care~     setting, the preferred locale of rural, older adults; the study will extend knowledge of the~     range of CBT applications by enrolling under-represented groups with respect to ethnicity,~     literacy, and financial resources.~      The primary aims of this project are (1) to determine the feasibility and maximal therapy~     characteristics of integrated CBT for co-occurring insomnia/depression in both the case study~     series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data on~     whether participants receiving integrated CBT + usual care show comparable or greater~     reductions in insomnia symptoms compared to participants receiving usual care at~     posttreatment and follow-up, and (3) collect pilot data on whether participants receiving~     integrated CBT + usual care show comparable or greater reductions in depression symptoms~     compared to participants receiving usual care at posttreatment and follow-up.~   "
146603|NCT01648036|"~     Life-threatening infections account for 10% of all intensive care unit admissions and~     constitute the second more frequent cause of death in the ICU after heart diseases. The most~     common cause of death in patients admitted with life-threatening infections is multi-organ~     failure that is mediated by severe inflammation. Given the relationship between inflammation~     and blood clotting, blood-thinners (also called anticoagulants) have been used to decrease~     inflammation and the formation of small clots. Several lines of evidence suggest that~     heparin, a proven and inexpensive blood-thinner, may reduce improve survival in patients~     diagnosed with life-threatening infection. The primary objective of this study is to~     demonstrate the feasibility of enrolling patients in a large randomized controlled trial~     investigating heparin in patients with severe infections. In this study, patients with~     life-threatening infections will have an equal chance of receiving an intravenous infusion of~     heparin, or a low dose of a similar drug to prevent of blood clots while patients are~     immobile. The primary purpose of the study is to demonstrate that an average of 2 patients~     per site, per month, can be enrolled. Other measures of feasibility include the consent rate,~     the number of protocol violations that occur during the trial, and the number of dose~     reductions needed due to excessive anticoagulation. To study the biologic effects of heparin~     in patients with severe infection, specific laboratory markers will be measured and analyzed.~     If the feasibility of the trial is confirmed, a large randomized trial designed to tell if~     heparin can safely improve survival will be conducted. Given its low cost and availability,~     if heparin is shown to improve survival in patients with severe infection, adoption of this~     therapy on a global scale is anticipated.~   "
146604|NCT01648023|"~     The purpose of this study is to find out if the combination of trans-arterial~     chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more~     effective than just receiving the infusional chemotherapy alone.~   "
146605|NCT01648010|"~     The purpose of this study is to evaluate the safety of intravesical instillation of TC-3~     Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary~     bladder.~   "
146620|NCT01647815|"~     The main objective of this study is the demonstration of an increase of over 50% of the~     surface visible on ultrasound (mm2) of the axillary vein and subclavian vein in arm abduction~     (90 °) and external rotation (90 °) with respect to the surface of the subclavian vein along~     the arm body.~   "
146606|NCT01647997|"~     Sepsis is characterized by hyperlactatemia, the severity of which is proportionate with~     sepsis severity. The pathophysiological mechanisms (increased lactate production vs decreased~     lactate utilization; tissues involved in sepsis-induced lactate production) remain largely~     unknown.~      In this study, the investigators will assess whole body and regional metabolism in healthy~     young male subjects on two occasions, once after administration of an intravenous bacterial~     endotoxin challenge, and once without intervention.~      In one group of subjects, whole body lactate metabolism will be measured over 10 hours after~     the endotoxin challenge~        -  Energy expenditure and net substrate oxidation rates (indirect calorimetry)~        -  Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)~        -  Glucose kinetics (measured with 6,6 d2 glucose)~        -  Hemodynamic parameters and body temperature~        -  Blood clinical chemistry In one group of subjects, whole body lactate metabolism will be~          measured over 10 hours after the endotoxin challenge~        -  Energy expenditure and net substrate oxidation rates (indirect calorimetry)~        -  Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)~        -  Glucose kinetics (measured with 6,6 d2 glucose)~        -  Hemodynamic parameters and body temperature~        -  Blood clinical chemistry~      In a second group of subjects, regional muscle lactate metabolism will be measured over 10~     hours after the endotoxin challenge by means of muscle microdialysis~   "
146607|NCT01647984|"~     Study on the role of a combination of nutraceuticals (Ritmonutra) with an effect on benign~     supraventricular and ventricular extrasystoles in subjects free of a specific organic heart~     disease. It has been suggested treatment with a nutritional supplement, able to normalize the~     'cardiac electrophysiology' and help to maintain wellness. Ritmonutra ® is a combination of~     nutraceuticals®, including Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin and~     Vitamin E, help to normalize the heart pacing, reducing the total number of benign~     extrasystoles and consequently improving the quality of life.~   "
146608|NCT01647971|"~     The purpose of this study is to determine whether ublituximab is safe and effective in~     patients with relapsed or refractory B-cell lymphoma who were previously treated with~     rituximab.~   "
146609|NCT01647958|"~     The purpose of this study is to assess the efficacy and safety of Transoral Incisionless~     Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI)~     therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with~     refractory symptoms on Proton Pump Inhibitors (PPIs).~   "
146610|NCT01647945|"~     Mutations in bone morphogenetic protein receptor 2 (BMPR2) are present in >80% of familial~     and ~20% of sporadic pulmonary arterial hypertension (PAH) patients. Furthermore~     dysfunctional BMP signaling is a general feature of pulmonary hypertension even in~     non-familial PAH.~      We therefore hypothesized that increasing BMP signaling might prevent and reverse the~     disease. We screened > 3500 FDA approved drugs for their propensity to increase BMP signaling~     and found FK506 (Tacrolimus) to be a strong activator of BMP signaling. Tacrolimus restored~     normal function of pulmonary artery endothelial cells, prevented and reversed experimental~     PAH in mice and rats.~      Given that Tacrolimus is already FDA approved with a known side-effect profile, it is an~     ideal candidate drug to use in patients with pulmonary arterial hypertension.~      The aims of our trial are:~        1. Establish the Safety of FK506 in patients with PAH.~        2. Evaluate the Efficacy of FK506 in PAH~        3. Identify ideal candidates for future FK506 phase III clinical trial.~   "
146611|NCT01647932|"~     The purpose of this study is to determine whether a combined diuretic therapy (loop diuretics~     with thiazide-type diuretics) is more effective (in terms of improving fluid overload~     symptoms) among patients with decompensated heart failure in comparison with loop diuretic~     alone.~   "
146612|NCT01647919|"~     The purpose of the study is to examine the efficacy of cogniVida™ on learning and memory~     performance (executive function, associative, spatial and verbal memory) as well as on mood~     and attention parameters after four, eight and eleven weeks of supplementation and in~     comparison with placebo.~      cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by~     the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug~     Administration does not strictly regulate herbs and dietary supplements. The investigators do~     not claim that this supplement is meant to treat any ailment.~   "
146613|NCT01647906|"~     The purpose of this observational study is to evaluate the safety and effectiveness of the~     Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a~     real world setting.~   "
146614|NCT01647893|"~     A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose~     Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001~     Intravenously Administered in Healthy Male Subjects~   "
146615|NCT01647880|"~     In the MOVING study should be examined, whether early therapeutic intervention with~     fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a~     comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual~     evoked potentials (mVEP) after 6 month compared to baseline.~   "
146616|NCT01647867|"~     Our project, established through collaboration between clinicians (Oscar Lambret~     Center-University Hospital) and scientists (IBL), aims to evaluate the expression of Met~     fragments in the lung cancer (LC). Unlike previous studies on Met by sequencing, in situ~     hybridization or immunohistochemistry, the investigators propose a protein analysis by~     Western blot of tumor samples and healthy tissue. This approach will evaluate the expression~     of full-length receptor, the potential presence of intracellular fragments, and their~     phosphorylation status.~   "
146617|NCT01647854|"~     The aim of the study is to investigate the safety and efficacy of the operation of a~     prehospital teleconsultation system in the Emergency Medical Service.~   "
146618|NCT01647841|"~     The purpose of this study is to understand how differences in the nutritional status and~     concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant~     women living in a semi-rural and rural region of northern Tanzania affect fetal growth,~     pregnancy outcomes and early infant health and development. The study hypothesis is that HIV+~     women will have worse nutritional status and a greater degree of cachexia which will~     negatively impact fetal growth, pregnancy outcomes and early infancy health and development.~   "
146621|NCT01647802|"~     The main objective of this study is to evaluate via a physiological analysis of the movements~     involved in standing, the level of forward flexion of the spine (in cm on the horizontal~     axis) obtained with the apparatus Tina and to compare levels obtained in the same patients~     with stander/transfer devices Turner and Vertic'Easy.~   "
146622|NCT01647789|"~     This study will assess the safety and preliminary antitumor activity of CFG920, a new CYP17~     inhibitor in castration resistant prostate cancer patients who are abiraterone naive or~     abiraterone resistant.~   "
146623|NCT01647776|"~     The investigators propose a screening population-based study to systematically evaluate the~     accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy~     screening. In addition, the investigators propose a genetic epidemiologic study of the~     relation between colon polyps, an established precursor of colon cancer, and two factors that~     may influence risk for colon cancer: candidate genes and diet.~   "
146624|NCT01647763|"~     Background:~      Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive~     procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less~     postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy~     are examples for such modern procedures. Hemorrhoidal artery ligation causes less post~     operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate.~     Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence~     rate without increasing the post operative pain.~      Hypothesis and aim:~      The study tries to prove the assumption that combined hemorrhoidal artery ligation and~     rectoanal repair cause less pain and have less post operative complications than stapled~     hemorrhoidopexy.~   "
146625|NCT01647750|"~     All patients with hypothyroidism are currently treated the same way, regardless of age. The~     investigators want to look at whether people aged 80 years or older would benefit from being~     treated with lower doses of levothyroxine. There are three reasons why the investigators~     think this could be beneficial, but this is not yet proven:~        1. Some older people with hypothyroidism may have few symptoms.~        2. Doctors look at the amount of Thyroid Stimulating Hormone (TSH) in the patient's blood~          to decide the dose of Thyroxine received. The standard normal TSH range used to~          determine the dose of levothyroxine is from younger people. The investigators wonder~          whether this is appropriate to all age ranges particularly as the investigators know~          that older people may normally have higher TSH values.~        3. If TSH levels are too low there may be a slight increased risk of problems such as~          brittle bones or an irregular heartbeat.~      The best way to test whether older people benefit from lower doses of levothyroxine is by a~     large clinical trial. Before the investigators can do this, the investigators need to run a~     smaller clinical trial called a pilot study (SORTED 1) to examine whether this is practical~     and acceptable. The pilot study aims to recruit 50 patients with hypothyroidism aged 80 or~     above.~      Participants will be randomly allocated to receive their routine or lower dose of~     levothyroxine. Follow-up will be conducted over approximately 25 weeks.~      The investigators also propose a qualitative study (SORTED 2) to specifically understand~     patient's willingness to take part in a RCT and participant's experience of the intervention.~      Finally, the investigators propose a retrospective cohort study of 400 treated hypothyroid~     patients aged 80 years or more registered in 2008 in Primary Care Practices with the aim of~     studying outcomes after 4 years. The cohort study will collect data required to inform a~     sample size calculation for a future full study where the primary outcome will be 4 year~     mortality.~   "
146626|NCT01647737|"~     The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia~     patent pending formulation of natural plant extracts on patients with xerostomia. The major~     component of this formulation is green tea extract with a defined composition of polyphenols.~     Epidemiological studies suggest that phytochemicals in green tea possess beneficial effects~     on autoimmune and inflammatory diseases. Thus far, there is little evidence to indicate any~     marked and direct immunomodulatory effect of green tea on T or B lymphocytes. However, there~     is considerable evidence for green tea polyphenols (GTPs), major phytochemicals found in~     green tea extract, having properties consistent with effects on cells of tissues that would~     be protective towards local inflammation.~   "
146627|NCT01647724|"~     The opportunity of a home, self-collected sample, opens the chance to remove some of the~     barriers that may discourage women from participating to screening programmes or performing~     HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as~     compared with tests performed at a clinic. It allows for privacy, reduces discomfort and~     women know nobody would have to handle their body.~      Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women~     at cervical cancer screening.~   "
146628|NCT01647711|"~     This trial is divided into Part A and Part B. The primary objective of Part A is to establish~     the Maximal Tolerated Dose of intermittent high dose afatinib. The primary objective of Part~     B is to assess the response rate of patients with non-small cell lung cancer with EGFR T790M~     mutations to a dose of intermittent afatinib established in Part A.~      The secondary objective is to explore tumor response and tumor-derived biological markers of~     response to afatinib, as well as pharmacokinetic parameters of afatinib.~   "
146629|NCT01647698|"~     This project will investigate the feasibility and preliminary effectiveness of an intensive~     and focused working memory training program for patients in the early stages of PD receiving~     dopaminergic therapy. The investigators hypothesize that working memory training will be an~     effective method of improving working memory and related cognitive and behavioural functions~     in PD patients.~   "
146630|NCT01647685|"~     A promising strategy to reduce CVD is to directly target inflammation at the level of the~     vessel wall. A potential drawback of anti-inflammatory strategies pertains to the thin line~     between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression. One of~     the strategies to limit systemic immunosuppression is to strive for local delivery and~     prolonged efficacy and low systemic burden of the drug by encapsulating the compound in~     liposomes.~      Liposome-encapsulated drugs efficiently target lesions and accumulate at a much higher extent~     at desired areas of interest. Thus, local delivery and prolonged efficacy can be very~     important tools to overcome the potential drawback anti-inflammatory drugs; namely an~     inappropriate immune suppression. In the present project, the investigators therefore aim to~     evaluate the delivery and superior efficacy of Nanocort above Prednison or placebo in~     patients with peripheral artery disease due to atherosclerosis. Because these patients will~     undergo an endarteriectomy the investigators will be able to collect atherosclerotic material~     after drug administration and thus evaluate the local delivery and compare the effects of~     Nanocort to Prednison or Placebo.~   "
146631|NCT01647672|"~     Select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them~     with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as~     neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of~     Albumin-bound Paclitaxel.~   "
146632|NCT01647659|"~     The purpose of this open-label, randomized, 2-treatment, 2-period crossover study with~     incomplete washout is to evaluate the relative bioavailability of 2mg GSK1120212 pediatric~     oral solution formulation in comparison to 2mg GSK1120212 tablet formulation, to investigate~     the safety and tolerability of a single dose of the GSK1120212 pediatric oral solution~     formulation as compared to a single dose of the GSK1120212 tablet formulation, and to~     investigate the palatability of the GSK1120212 pediatric oral solution formulation.~      Subjects will be assigned to one of two possible treatment sequences according to the~     randomization code provided to the sites by GSK: a single dose of 2mg GSK1120212 pediatric~     oral solution formulation then a single dose of 2mg GSK1120212 tablet formulation, or a~     single dose of 2mg GSK1120212 tablet formulation, then a single dose of 2mg GSK1120212~     pediatric oral solution formulation. Administration of GSK1120212 in either sequence will be~     followed by 7 days of serial blood sampling for pharmacokinetic analysis of plasma~     GSK1120212. Safety assessments, including assessment of adverse events, clinical laboratory~     values (hematology, clinical chemistry and urinalysis) and vital signs, will be made~     throughout the study. After completing the pharmacokinetic assessments for two periods,~     eligible subjects may transition to MEK114375, an open-label rollover study of GSK1120212.~   "
146633|NCT01647646|"~     In real life, the investigators will be using different strategies including SMART therapy or~     other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.~   "
146634|NCT01647633|"~     Over 20 million Americans have allergic nasal symptoms including stuffiness, sneezing and a~     runny nose. AkPharma's Calcium Glycerophosphate used as a nasal spray wash is believed to~     improve these symptoms without side effects common to over the counter and prescription~     medication. It is hypothesized that Calcium Glycerophosphate will have a perceived~     improvement in breathing comfort.~   "
146635|NCT01647620|"~     A study to investigate the concentrations of a new drug DPOC-4088 in blood, and to study the~     effect of this drug on blood clotting parameters. Furthermore the relation between the blood~     concentrations and the blood clotting effect will be investigated. Safety will be~     investigated as well. The objective of these investigations is to determine the optimal dose~     of DPOC-4088 that, achieves a relevant increase in a specific blood clotting parameter (the~     ecarin clotting time) without safety concerns.~   "
146636|NCT01647607|"~     The purpose of this study is to address gaps in care of young women with breast cancer by~     determining whether educational interventions focusing on issues unique to young women with~     breast cancer and healthy lifestyles for women with breast cancer help to improve care of~     young breast cancer patients. The investigators believe that if addressed early in a young~     woman's care, concerns related to fertility, body image, sexual dysfunction, and physical~     activity will improve the satisfaction with care and quality of life of this vulnerable~     population. The research will be conducted by exporting refined, previously piloted~     educational interventions to 14 academic sites and 40 community medical clinics. The~     investigators will compare how interaction with each intervention affects patients' quality~     of life and satisfaction with quality of care.~   "
146637|NCT01647594|"~     This is a pilot study, which will inform a larger study to evaluate the Young Women's~     Intervention (YWI). The goal of this research is to develop, implement and test a refined~     exportable and sustainable education and support intervention for young women with breast~     cancer and their oncology providers. This pilot study will test the feasibility of the Young~     Women's Intervention (YWI) as well as a Physical Activity Intervention (PAI) at four unique~     sites. In addition, it will include a qualitative assessment, through focus groups and key~     informant interviews, of concerns facing young women with breast cancer. The investigators~     aim to use the findings from this pilot study to inform a larger future Young Women's~     Intervention (YWI) study where the YWI intervention will be compared to a Physical Activity~     Intervention (PAI).~   "
146638|NCT01647581|"~     A randomized trial aimed at determining whether or not hemoclips are effective in preventing~     post-polypectomy bleeds on polyps that are 10mm in size or greater.~   "
146639|NCT01647568|"~     At our VA hospital, in general, it is the policy of our GI lab to not stop our patients~     anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we~     believe the risk of stopping these sort of medications outweigh the risks of a complication~     from a colonoscopy.~      Therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any~     anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We~     perform the procedure just like we normally would and then follow-up with the patient 7 and~     30 days after their procedure.~   "
146640|NCT01647555|"~     This study evaluates the skin toxicities in patients with epidermoid cancer, treated by~     Radiotherapy in association with Cetuximab.~   "
146641|NCT01647542|"~     The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific~     adults with type 2 diabetes mellitus (T2DM).~   "
146642|NCT01647529|"~     Objective of this study is to investigate the intracameral level of ganciclovir following~     topical application of 0.15% ganciclovir gel (VIRGAN©) for Cytomegalovirus (CMV) anterior~     uveitis and endothelitis. Thirty patients who are diagnosed with CMV anterior segment~     infection, either uveitis or endothelitis, who have a positive aqueous real time PCR (RT-PCR)~     and/or positive tetraplex PCR for CMV and have not had any form of ganciclovir treatment in~     the past 1 month, will be recruited in the study after taking an informed consent. with~     active CMV anterior segment infection confirmed by a positive aqueous real time PCR (RT-PCR)~     and have not had any form of ganciclovir treatment in the past 1 month were recruited in the~     study. Patients were given 0.15% ganciclovir gel 1cc 5 times a day for 6 weeks. Following 6~     weeks of treatment, tears and aqueous samples will be collected. Aqueous will be sent for~     RT-PCR for CMV status. Ganciclovir drug level in both tears and aqueous will be measured by~     HPLC method. Clinically, degree of the intraocular inflammation, Intraocular pressure (IOP)~     and central corneal thickness (CCT) will be recorded at baseline and post-treatment.~   "
146643|NCT01647516|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     ulcerative colitis (UC).~   "
146776|NCT01645280|"~     The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in~     reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA)~     despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and~     CNTO 1959 in this population.~   "
146644|NCT01647503|"~     Primary hyperparathyroidism (PHPT) is one of the common endocrine disorders. The major~     clinical symptoms involve stones, bones, abdominal groans and psychiatric moans. Increased~     parathyroid cell proliferation and decreased calcium-mediated control of the PTH secretion~     are characteristic findings. The most common cause of PHPT is adenoma followed by hyperplasia~     and carcinoma.The molecular mechanisms involved in parathyroid tumorigenesis are partially~     known. Few genes have been identified and their roles are under study.~      The genes which are under study by different groups are unable to give a definite direction~     towards the understanding of parathyroid tumorigenesis and the mechanism involved in~     overgrowth of parathyroid tissue. So identifying different proteins and their regulation~     pattern from adenomas to carcinomas will be the initial steps towards understanding the~     proteins involved in tumorigenesis of parathyroid tissues. By using proteomics approach one~     can generate protein level information. In this study, using a combined approach based on 2 D~     gel electrophoresis and mass spectrometry (MS), the investigators propose to study a~     comparative proteomics to examine the changes of protein profiles in parathyroid tumor~     tissues with normal and hyperplasic parathyroid tissues. This work plan will help us to~     understand differentially expressed proteins in patients with PHPT. This will help in~     understanding the disease and identifying better diagnostic and curative measures of the~     disease. The investigators are also planning to access nuclear morphometry changes in~     sporadic parathyroid tumors. It will help in establishing cellular and nuclear change pattern~     variations from normal to parathyroid tumors.~   "
146645|NCT01647490|"~     This study is a long-term, prospective, and controlled evaluation of the mechanical~     dyssynchrony induced by right ventricular apical pacing, both in acute (spontaneous and~     stimulated) and chronic (12 and 24 months); the study also evaluates the benefit of an~     alternative pacing site through measures of dyssynchrony in acute and chronic.~   "
146646|NCT01647477|"~     This study aims to determine the impact of sociocognitive and emotional factors on the time~     of the initial consult~   "
146647|NCT01647464|"~     Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study~     is to determine whether there is retention of ultrasound contrast agents in the renal~     microcirculation, which has been described in mice.~   "
146648|NCT01647451|"~     This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease~     activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to~     placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX)~     therapy.~   "
146649|NCT01647438|"~     Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the~     feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle~     intervention to improve the cardiovascular health of underserved South Asian (Indian,~     Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will be~     randomly assigned to either a group to receive heart disease prevention classes or to another~     group where they will receive written materials about heart disease prevention.~   "
146650|NCT01647425|"~     This is an multicenter study for preventive and therapeutic strategies for patients with head~     and neck cancer~   "
146651|NCT01647412|"~     Of the estimated one million Americans with inflammatory bowel disease (IBD), approximately~     20-30% develop this condition during childhood or adolescence, most of whom have Crohn's~     disease (CD). It appears that some individuals are genetically susceptible to certain~     nutrients, causing inflammation and disturbance of their immune system, as well as disruption~     of the intestinal barrier. This leads to malnutrition and inhibited growth, with many~     patients experiencing intense abdominal pain and diarrhea.~      Most physicians treat the disease with drugs that suppress the immune system and decrease the~     inflammatory process. Although these drugs frequently induce remission, most patients~     experience a subsequent return of symptoms and fail to catch up on their growth.~     Additionally, serious side effects are associated with these drugs.~      Individuals genetically prone to CD are believed to have a leaky gut that allows substances~     to pass through the intestinal wall and react with the underlying immune system. Furthermore,~     those nutrients that are toxic to these individuals pass through the decreased intestinal~     barrier triggering an extreme immune response. Nutrients that have been implicated include~     grains, except rice, dairy products, and any food containing carrageenan. Excluding these~     nutrients from the diet has been shown to beneficial for CD patients. Certain nutraceuticals,~     such as curcumin and omega-3 fatty acids, have been shown to provide anti-inflammatory~     effects in IBD patients. In addition, the administration growth hormone (GH), has been shown~     to alleviate symptoms, by enhancing the repair of the intestinal epithelium, preventing toxic~     antigens from reaching the underlying lamina propria.~      Previous studies and case reports provide incomplete evidence that exclusion diet with~     nutraceuticals (DNT) and GH lead to sustained long term remission in juvenile CD,~     discontinuation of other CD drugs, and catch up growth. This study is designed to test this~     hypothesis. Patients in the treatment group will be treated with DNT and GH, while continuing~     to receive medications from their physician while the control group will receive DNT, placebo~     injections instead of GH. We predict that the treatment group will show greater improvement~     than the control group.~   "
146652|NCT01647399|"~     Asthma has become considerably more prevalent and severe in the U.S. during the last 40~     years, particularly affecting youth in urban areas, yet the reasons for this are not clear.~     There is increasing evidence that vitamin D insufficiency contributes to more severe asthma~     through increased risk of respiratory infections and decreased sensitivity to~     glucocorticoids. Indeed, low vitamin D levels are linked with the need for exogenous~     glucocorticoids and increased asthma severity. Particularly relevant to health disparities,~     we showed a strong association between vitamin D insufficiency and asthma in urban African~     American (AA) youth. Importantly, AA youth in ours and other studies had lower vitamin D~     levels than non-AA participants.~      Because AA youth residing in urban Washington, DC have markedly worse asthma than other~     racial/ethnic groups (e.g. prevalence rate 20% higher than the national rate 15 and emergency~     department utilization rates up to 5 times the national rates and nearly 10 times the Healthy~     People 2010 target rate), we will utilize our access to this population at the extreme of~     asthma disparities to examine the contribution of vitamin D to disparities in the chronic~     control and acute severity of asthma. The overall goal of this study is to provide critical~     epidemiological/molecular information that will inform the interpretation of ongoing and~     impending randomized clinical trials of vitamin D supplementation in asthma, especially with~     regard to urban AA youth with asthma. We hypothesize that low serum 25-hydroxyvitamin D~     [25(OH)D] levels are associated with poor chronic asthma control, worse acute asthma~     severity, and glucocorticoid insensitivity. The knowledge generated by the experiments in~     this application will be crucial to translation of this inexpensive, easily-accessible, and~     thereby potentially disparity-reducing prospective therapy for asthma.~   "
146668|NCT01647191|"~     The proposed study will investigate the knowledge level, attitudes, and perceptions among~     staff of Methadone Maintenance Treatment (MMT) clinics and intravenous drug users (IDUs) who~     attending MMT clinics, which is the most reachable population for HCV/HIV intervention in~     China. This study will also explore the barriers that prevent IDUs from getting HCV/HIV~     intervention/prevention and medical care services. This study will help to understand and~     address this important problem in China and other Asian countries.~   "
146669|NCT01647178|"~     The proposed trial is to evaluate the use of the TORQ closure assistance device and how it~     affects pain in the sternum, breathing and quality of life compared to traditional use of~     needle drivers or similar to close sternal wires.~   "
146653|NCT01647386|"~     Motivated by the growing number of revision total knee arthroplasty (TKAs) and the interest~     among surgeons to quantify the effectiveness of specific implant designs, the goal of the~     current project is to use Radiostereometric Analysis (RSA) to provide conclusive and~     clinically relevant results on fixation of the tibial component with the DePuy M.B.T.~     Revision TKA system using Metaphyseal Sleeves.~      Does the tibial component of the M.B.T. Revision Knee System achieve adequate fixation to the~     underlying bone (proximal tibia) as measured by migration? • Null Hypothesis: The maximum~     total point motion (MTPM) value of migration of the M.B.T. Revision Knee System component~     between postoperative years one and two does not exceed 0.2 mm indicating adequate long-term~     fixation at the bone-implant interface.~      • Alternative Hypothesis: The MTPM value of migration of the M.B.T. Revision Knee System~     component between postoperative years one and two does exceed 0.2 mm indicating inadequate~     long-term fixation at the bone-implant interface.~      b) In what proportion of patients is adequate fixation achieved?~   "
146654|NCT01647373|"~     All existing medical literatue regarding axial length (AL) changes after scleral buckling~     surgery for retinal detachment, descibes changes after solid silicone buckling. In this~     hospital, the investigators use only silicone sponge buckling, which has different properties~     and a different buckle profile. there are no studies in the literature describing tha AL~     changes after sponge buckling, or whether the AL change is less or more than with solid~     silicone buckles. The investigators wish to determine whether the AL change profile with~     their silicone sponge is significantly different, and if so, whether this is clinically~     important in determining the better choice of buckle material to be preferred.~   "
146655|NCT01647360|"~     Dydrogesterone is a retroprogesterone with a molecular structure similar to natural~     progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low~     antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic~     activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.~      In this study, women suffering from menorrhagia and who are treated with dydrogesterone will~     be observed for impact on QoL with the reduction in severity of bleeding.~   "
146656|NCT01647347|"~     The study investigates the effect of supra- and subgingival rinsing of 10% PVP prior to~     ultrasonic debridement in patients with periodontitis (as compared to rinsing with water) in~     terms of post treatment bacteraemia.~      Study design: Randomized split-mouth (cross-over) study on 20 generally healthy subjects.~   "
146657|NCT01647334|"~     This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent~     treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too~     large for standard curative treatment. The study will use adaptive radiotherapy to achieve~     these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during~     the course of treatment due to patient and tumor variations (ie. weight loss or tumor~     shrinkage). This may allow for dose escalation, while limiting the side effects.~   "
146658|NCT01647321|"~     Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for~     which there are no existing therapies that alter the disease course. This research will~     utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal~     of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling~     will improve walking in subjects with SPMS.~   "
146659|NCT01647308|"~     The purpose of this study is to evaluate the effects of ISIS ISIS-APOCIIIRX on Triglyceride~     Levels and Insulin Sensitivity in Subjects with Type 2 Diabetes on stable treatment with~     metformin.~   "
146660|NCT01647295|"~     The primary objective of this work will first to characterize in typical childhood, visual~     exploratory behavior and pupillary response associated with salience of human social stimuli~     (faces and body movements), and then to evaluate these markers in children with autism.~      The second objective of this work will be to achieve in a population of children with autism~     a longitudinal evaluation of these markers during development and therapeutics.~   "
146661|NCT01647282|"~     The purpose of this study is to determine the effect of local application of minocycline~     microspheres on the periodontal inflammation and bone loss prevention in patients diagnosed~     with moderate-severe chronic periodontitis within a periodontal maintenance program.~   "
146662|NCT01647269|"~     The purpose of this study is to investigate whether deep brain stimulation (DBS) of the~     globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS) and~     whether this treatment has any influence on social, psychological and behavioral disability~     and quality of life.~   "
146663|NCT01647256|"~     The primary purpose of this study is to evaluate if eating a high fat meal versus not eating~     any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second~     purpose is to gain further information about the safety of Nikkomycin Z in healthy adults.~   "
146664|NCT01647243|"~     The purpose of this study is to investigate if preoperative strength training will result in~     faster recovery and higher level of function six weeks after total knee arthroplasty (TKA).~   "
146665|NCT01647230|"~     The aim of this study is to observe how the hemodynamic changes induced by spinal blockade~     affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent~     during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting~     cardiac output and cerebral blood flow. These complications of spinal anaesthesia could~     decline cognitive function. In this way a non invasive monitoring technique as cerebral~     oximetry is useful for the safety of anesthetic procedure.~   "
146666|NCT01647217|"~     This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol~     (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis~     (reducing ocular demodex counts and achieving the clinical improvement with minimal or no~     irritation).~   "
146667|NCT01647204|"~     The primary objective of the study is to determine if the use of volunteers employed~     specifically to focus on mealtime assistance can increase food and nutrient intake of~     patients admitted to an acute Care of the Elderly ward. The sustainability of providing~     helpers to increase dietary intake over a year will be assessed and linked to actual dietary~     intake. The secondary objectives are to assess the association between dietary intake~     resulting from mealtime assistance and patient satisfaction, malnutrition risk, body~     composition, grip strength, length of hospital stay and hospital mortality.~   "
146670|NCT01647165|"~     Background: Bortezomib is a drug approved by the Food and Drug Administration (FDA) to treat~     patients with multiple myeloma. It is given by intravenous injection. Lenalidomide is a drug~     that alters the immune system. It may also help suppress tumor growth. It is approved by the~     FDA to treat some types of blood cancers. Dexamethasone prevents or treats inflammation. It~     is sometimes used to treat multiple myeloma.~      Objectives: The purpose of this study examine how the combination of the study drugs affects~     myeloma.~      Eligibility:~        -  Participants at least 18 years old who have multiple myeloma that has come back, did not~          respond to treatment, or worsened while being treated.~        -  Participants who may be pregnant will be tested to ensure that they are not pregnant.~      Design:~        -  Participants will be screened with a history and physical examination. Blood work and~          urine samples will be taken. A series of x-rays of all bones will be done. A bone marrow~          biopsy will be done.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Treatment will continue as long as the cancer does not grow or spread and no serious~          side effects develop.~        -  There will be up to eight 21-day treatment cycles.~        -  Bortezomib is given by subcutaneous (under the skin) (SC) injection on days 1, 4, 8, and~          11 of the cycle.~        -  Lenalidomide is given by mouth on days 1 14 of the cycle.~        -  Dexamethasone is given by mouth on days 1, 2, 4, 5, 8, 9, 11, and 12 of the cycle.~        -  Following cycle eight, if the disease is stable or better, participants will receive~          bortezomib SC at the dose given at the end of cycle eight.~        -  Participants will take valacyclovir or acyclovir while taking bortezomib to prevent~          virus infections.~   "
146671|NCT01647152|"~     Background:~      - Uveitis is an eye inflammation that can cause vision loss. It is treated with eye drops,~     drugs and sometimes surgery. In some people, treatment may not prevent vision loss. A type of~     white blood cells called T-cells often have a role in causing uveitis. In some cases of~     uveitis, T-cells attack the eye and cause inflammation. A drug called ustekinumab reduces~     inflammation from these T-cells. Researchers want to see if ustekinumab can be used to treat~     uveitis.~      Objectives:~      - To see if ustekinumab can be used to treat uveitis.~      Eligibility:~      - Individuals at least 18 years of age who have active uveitis that needs treatment.~      Design:~        -  Participants will be screened with a physical exam, eye exam, and medical history. Blood~          and urine samples will be taken.~        -  Participants will have at least eight clinic visits during the 64-week study period.~          After the first visit, visits will occur at 2, 4, and 8 weeks, and then every 12 weeks.~        -  Participants will have a ustekinumab injection at the first study visit. They will have~          additional doses at the second and third visits, and then every 12 weeks until 1 year~          after the first dose (Week 52).~        -  Treatment will be monitored with frequent blood tests and eye exams. Other standard~          treatments for uveitis may be given as needed.~        -  There will be a final study visit 3 months after the last injection.~   "
146672|NCT01646866|"~     Rationale: Autism Spectrum Disorder (ASD) is defined by deficits in social interaction and~     communication identified before the age of 3 years. Modified Checklist for Autism in Toddlers~     (M-CHAT) is a sensitive tool for ASD screening in children 16-23 months. A limited number of~     studies with a small number of patients have documented the developmental profile of children~     with ASD during infancy. Retrospective evaluations of videotaped behavior of children with~     ASD at 8 months and at 12 months identified early signs of ASD. A few studies found early~     signs of ASD during infancy in siblings of autistic children. Data documenting the age of~     onset and regression in ASD is controversial and limited. No large prospective studies~     documented the specific developmental profile of children with ASD starting at 6 months of~     age. Defining a specific autistic pattern on a developmental screening test could help~     identify infants at risk for ASD and improve their outcome through earlier diagnosis and~     treatment. More recently, genetic tests have been shown to aid in early identification of ASD~     which facilitates earlier intervention. Genetic testing among siblings of children with~     autism can aid in identification of autism or other related disorders in the siblings.~      PURPOSE: The purpose of this study is to learn about the early signs of autism in siblings of~     children with autism spectrum disorders.~        -  The investigators will enroll siblings of children with ASD. Those siblings who~          completed the Red Flags for Communication scale (RFC) at 6 months and/or at 12 months~          and failed the RFC at 12 months will be given a genetic screening test.~        -  It is the investigators goal to define a specific autistic pattern on a developmental~          screening test that could help identify sibling infants at risk for ASD and improve~          their outcome through earlier diagnosis and treatment and to evaluate if the results of~          the clinical screening test will correlate with the results of the genetic screening~          test.~   "
146673|NCT01646853|"~     The objective of this study is to determine the optimal radiation dosage used in concurrent~     chemo-radiotherapy in Chinese population. A dose climbing experiment is carried out with an~     initiate dose of 50Gy conventionally applied in Western countries.~   "
146674|NCT01646840|"~     This study will assess the relative bioavailability of a capsule formulation of PF-04958242,~     relative to a oral solution formulation of PF-04958242 in healthy adult subjects.~   "
146675|NCT01646827|"~     The purpose of this study is to determine whether aripiprazole injection into the shoulder or~     the buttocks produces similar effects in the body~   "
146676|NCT01646814|"~     This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury~     after the oral administration of an investigational product, PL2200, and a marketed 325 mg~     immediate-release aspirin product. Each group will be treated with either an~     immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and~     evaluated via an endoscope for any gastrointestinal injury that may have been caused by study~     medication.~   "
146677|NCT01646801|"~     The purpose of this study is to demonstrate the Safety and effectiveness of the use of NMB's~     drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral~     arterial disease.~   "
146678|NCT01646788|"~     The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's~     percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of~     Arteriovenous (AV) Dialysis Fistulae/Grafts.~   "
146699|NCT01646502|"~     Chronic wounds cause significant morbidity and cost our healthcare system millions of dollars~     each year.Their healing is slowed by biofilms, communities of bacteria surrounded by a~     protective layer that stops the immune system and antibiotics from getting close enough to~     kill them. The investigators will develop a new strategy to destroy biofilms using a protein~     made from bacteria that live on our skin.The Staphylococcus epidermidis Esp protein will be~     used to destroy Staphylococcus aureus biofilms, the most common bacterium in chronic wounds.~     The investigators hypothesize that the use of the Esp protein will breakdown S. aureus~     biofilms, decrease bacterial colonization of chronic wounds and improve healing times.~   "
146700|NCT01646489|"~     The purpose of this study is to assess the safety, tolerability, and affect on blood levels~     of miravirsen and telaprevir when administered together.~   "
147291|NCT01638507|"~     The purpose of this post approval study is to conduct a prospective, multicenter evaluation~     of the procedural and clinical outcomes of subjects that are treated with the commercially~     available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.~   "
146679|NCT01646775|"~     Background: For cancer to grow and metastasize, inflammatory and immunologic conditions in~     the host must be favorable. The perioperative period provides inflammatory and immunologic~     changes that may be pro-malignant. Anesthetic medications, including the use of opioid~     medication, may contribute to these changes.~      Hypothesis: The investigators hypothesize that perioperative immunologic changes in patients~     undergoing resection of hepatic colorectal cancer recurrence, as measured by natural killer~     cell function and cytokine levels, will undergo less alterations in those who receive only~     epidural bupivacaine, as compared to those who receive epidural bupivacaine and fentanyl.~      Methods: In this double blind control trial patients with no extra-hepatic evidence of~     cancer, undergoing a planned curative resection of hepatic recurrence of colorectal cancer,~     will be randomized to receive an epidural with bupivacaine and fentanyl, or bupivacaine~     alone. No other perioperative opioid medication will be given, and post-operative analgesia~     will be supplemented with acetaminophen and gabapentin. Blood samples and pain ratings using~     a verbal analogue scale will be obtained preoperatively, immediately and 6 hours~     postoperatively, and then daily until removal of the epidural catheter. Samples will be~     analyzed for levels of interleukin 2, 6, 8, 10, 12, 16, 17,TNF-α, TGF α and β, MCP-1, CRP,~     and NK cell activity. Cytokines will be measured using a suspension bead array immunoassay~     kit, and NK activity will be measured using flow cytometry of isolated peripheral blood~     mononuclear cells exposed to the K562 cell line and treated with fluorescent antibodies to~     intracellular markers of activation. Data will be compared between groups using t-tests, or~     Mann-Whitney tests as appropriate. To demonstrate a 50% smaller decrease of NK cell activity~     in the bupivacaine group as compared to the bupivacaine and fentanyl group the investigators~     will need to randomize a total of 30 patients.~   "
146680|NCT01646762|"~     This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation~     works in treating patients with multiple myeloma that has returned or did not respond to~     treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading.~   "
146681|NCT01646749|"~     The purpose of this study is to determine ad libitum daily energy intake, body weight changes~     and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive~     days, and in relation to age, gender, body mass index (BMI) and fat mass and~     obesity-associated (FTO) gene alleles.~   "
146682|NCT01646736|"~     Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral~     T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of~     patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical~     trial. Observation period of 24 weeks.~   "
146683|NCT01646723|"~     The objectives of our project are to: 1.) Develop a training program and manual for~     volunteers to implement evidence-based, non-pharmacological interventions for~     neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit and~     train volunteers using the VALID program and pilot test the volunteer-led program with 20~     individuals with Alzheimer's disease and NPS in a LTC facility in Kingston; and, 3.) Evaluate~     the effects of the VALID program on the symptoms of NPS, patient quality of life, volunteer's~     experience, and LTC staff stress.~   "
146684|NCT01646710|"~     The study aims to explore ways in which optifood can be developed to create relevant food~     based recommendation (FBR) and to used for advocacy purposes.~      The optifood tool will be pilot tested with relevant organizations and refine FBRs for the~     target population. Its performance will be assessed in the hands of Government/NGOs in Peru,~     Thailand and India to provide guidance on incorporating into their advocacy programs.~     Qualitative and quantitative methods will be used.~   "
146685|NCT01646697|"~     This study is being done to investigate another way of evaluating margin status after~     pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional~     method of surgical pathology~   "
146686|NCT01646684|"~     After failure of initial ADT, addition of an anti-androgen is established to treat castration~     resistant prostate cancer (CRPC). Substitution of the first anti-androgen and anti-androgen~     withdrawal results in treatment responses in 25-40% of patients for 4-6 months. A more~     effective second line treatment after failure of first ADT could prolong the time until the~     state of symptomatic HRPC, which is currently treated with docetaxel and accompanied by~     significant side effects. Since the importance of the IGF-signaling in PC is not only~     indicated by preclinical results but also by clinical efficacy of somatostatin analogs,~     further clinical research with the new somatostatin analog pasireotide is warranted.~      This study is designed to define the maximum tolerated dose (MTD) of pasireotide LAR in~     patients with castration resistant prostate cancer (CRPC). It also aims for a preliminary~     efficacy evaluation of pasireotide within the dose expansion part at the MTD. Preliminary~     efficacy will be assessed by evaluation of different measures of prostate cancer e.g. changes~     in PSA, disease control rate (RECIST 1.1), symptoms and changes of biomarkers linked to the~     mode of action of pasireotide LAR. The study will also explore characteristics of patients~     who might benefit most from this treatment approach~   "
146687|NCT01646671|"~     This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive~     Japanese patients~   "
146688|NCT01646645|"~     The purpose of this study is to see how well transfusions of T-cells work in treating CMV.~     T-cells are a type of white blood cell that helps protect the body from infection. A~     transfusion is the process by which blood from one person is transferred to the blood of~     another. In this case, the T-cells are made from the blood of donors who are immune to CMV.~     The T-cells are then grown and taught to attack the CMV virus in a lab.~   "
146689|NCT01646632|"~     Questions: Does an evidence-based exercise program increase activities of daily living and~     physical fitness in institutionalized older adults? Does this program decrease the care~     dependency of institutionalized older adults? Design: A randomized control trial using~     group-based exercise was performed in 14 assisted-living facilities for the elderly (>70~     years old).~      Outcome measures: Outcome measures were performance on ADL, physical fitness, and care~     dependency measures. The exercise program comprised group-based progressive resistance~     training, balance training, and functional training. The control intervention comprised~     social group meetings.~   "
146690|NCT01646619|"~     The purpose of this study is to assess whether the addition of a drug such as Magnesium~     sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated~     at birth provides additional benefit to the babies' survival and outcome compared to cooling~     alone.~   "
146726|NCT01646151|"~     An observational study comparing changing from an IOP-lowering treatment to a~     bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular~     hypertension (OHT). Visits and treatment are per normal clinical practice.~   "
147307|NCT01638299|"~     Feasibility study assessing the ability of an insulin pump-controlling algorithm to minimize~     hypoglycemia and hyperglycemia in patients with type 1 diabetes in a clinical research~     setting.~   "
146691|NCT01646606|"~     In infants hospitalized with bronchiolitis, a common infection in the lungs caused by a~     virus, it is uncertain on how to best monitor their oxygen levels. It is common to place a~     probe on infants hands or legs to monitor oxygen levels. The probe can be used to monitor~     oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours~     (intermittent oxygen monitoring). There is reason to believe that placing children with~     bronchiolitis on continuous monitoring might result in children staying longer in hospital~     than needed. This is a research study that is aiming to provide data to plan a larger~     research study to answer the question of whether intermittent oxygen monitoring is better~     than continuous oxygen monitoring. This study is part of a larger initiative to determine the~     best way to care for children with bronchiolitis, including making sure that children do not~     stay in hospital longer than needed.~      Parents will be asked to participate in this research study if their child is hospitalized~     with bronchiolitis and has been stable for at least 6 hours, meaning that he/she is not~     having more trouble breathing or does not require more supplemental oxygen. If they agree~     participate, the child will have one of the two oxygen monitoring strategies: intermittent or~     continuous monitoring. Each child will have an equal chance of getting one or the other of~     these two monitoring strategies.~      The study team will review the children's charts to determine the number of tests ordered,~     the need for intensive care unit help or admissions, the number of blood tests and chest~     x-rays the treating doctors ordered, and the length of hospital stay. Parents will be~     contacted about 4-5 days after discharge to ask if there were any unscheduled visits to~     doctors or emergency rooms after discharge. The investigators will the parents to fill out a~     scale twice a day asking how well their child is feeding. The investigators will also them to~     rate their anxiety level once a day.~      The information from this study will help plan and support an application for external~     funding. The results of a larger study could potentially decrease unnecessary monitoring,~     oxygen supplementation, and hospital stay and thereby improve quality of care with large cost~     savings. A reduction in length of hospital stay for this common hospital condition would also~     reduce the burden of hospitalization to families and reduce the risks associated with harm in~     the hospital setting such as infection and medical error.~   "
146692|NCT01646593|"~     The objective of the trial is to provide regorafenib to subjects diagnosed with metastatic~     and / or unresectable GIST who have progressed after standard therapy.~      Selected additional safety information on regorafenib will be collected and progression-free~     survival (PFS) will be estimated.~   "
146693|NCT01646580|"~     Ciclopirox olamine (Ciclochem®) is a pyridone broad spectrum antifungal drug which has shown~     activity on dermatophytes, yeasts, moulds, actinomycetes and some bacteria. Its mechanism of~     action is based on a fungicidal activity by inhibiting the cellular captation of essential~     substances needed for the metabolism and growth of the fungi. On the other hand, this drug~     binds irreversibly with cell structures as mitochondria, ribosomes, microsomes and cell wall.~     After dermal application, Ciclopirox olamine undergoes skin penetration, being only absorbed~     a 1,5% of the applied dose. Clinical efficacy has been studied in patients above 10 years~     with superficial dermatomycoses (dermatophytoses, candidiasis and pityriasis versicolor) and~     the percentage of clinical healing ranged from 77% to 91% after 2-4 weeks of twice a day~     topical application. In all the studies, the safety profile has been very good, showing only~     a very low rate of adverse events of mild to moderate intensity. There are very few previous~     available data on the application of this compound in children under 10 years of age. A~     single study had been performed with a solution formulation in patients from 6 to 29 months~     with diaper candidiasis, showing good efficacy and tolerability in these patients. The~     present study aims to show the safety and tolerability of ciclopirox olamine in a cream~     formulation in patients from 3 months to 10 years with dermatomycoses.~   "
146694|NCT01646567|"~     The purpose of this study is to assess the safety, tolerability and clinical activity of the~     SHP-141C topical cream formulations in patients with plaque type psoriasis.~   "
146695|NCT01646554|"~     Patients presenting with multiple innumerable liver metastases will probably never come to~     resection, however, for all others, including patients with numerous multiple metastases or~     large metastases, resection should be considered after limited chemotherapy.~      There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin.~     FOLFOX was used in the previous EORTC study and is again recommended.~      The addition of targeted agents to standard chemotherapy in the perioperative strategy for~     mCRC might increase the ORR and R0 resectability, without significant increase in toxicity,~     therefore translating to a better outcome.~      BOS2 (EORTC 40091) was designed to test this hypothesis in patients with a KRAS wold-type~     profile.~      It was decided in parallel to design an open label, randomized, multi-center, 2-arm phase~     II-III study this time aimed at enrolling KRAS mutated patients.~      Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Aflibercept + Surgery~   "
146696|NCT01646541|"~     Most patients with mitral valve disease are symptomatic with shortness of breath and a~     limited activity level prior to mitral valve surgery. Despite surgical repair or replacement~     of the mitral valve, many patients remain symptomatic with an impaired ability to live an~     active lifestyle. Often after extensive evaluation, no other pulmonary, left ventricular~     dysfunction, or valvular heart disease is responsible for the continued symptoms, and some of~     these patients will be limited by persistent pulmonary hypertension (PH) at rest or with~     exertion that is responsible for limiting their activity level and impacting their quality of~     their life.~      It is our goal in the proposed study to systematically characterize symptomatic and~     asymptomatic patients greater than six months after mitral valve surgery using clinical data,~     echocardiographic evaluation, laboratory assessment, and in some patients, invasive~     hemodynamic measurements. The investigators will screen asymptomatic and symptomatic patients~     with resting echocardiography and also with echocardiography during exercise, as many~     patients will exhibit exercise-induced PH following mitral valve surgery. Pulmonary artery~     (PA) pressure will be estimated from echocardiography using Doppler-derived calculations. If~     elevated PA pressures are observed with echocardiography, then symptomatic patients will~     undergo right heart catheterization for invasive pressure measurement, which is the~     gold-standard for the diagnosis of PH. When PH is present and there is a normal wedge~     pressure (PCWP) during invasive pressure measurement, further assessment to identify~     potential candidates for PH therapy will be performed. This involves having patients breathe~     inhaled nitric oxide, a rapid-acting, pulmonary vasodilator with a short half-life. While~     breathing inhaled nitric oxide, blood pressure, PA pressure, PCWP, and cardiac output will be~     monitored to characterize individuals who could benefit symptomatically from pharmacotherapy~     to treat underlying PH. It is important to note that only a small minority of patients~     exhibit a positive vasodilator response and those with PH and a normal PCWP without an~     initial vasodilator response would still be identified as candidates for chronic PH therapy.~      The information generated from this proposed research will make a significant contribution to~     the understanding of PH in a group of patients in whom it has not been previously studied.~     Scientific reports on the evaluation of patients with PH after mitral valve surgery are~     almost nonexistent from the modern era. Furthermore, patients with PH due to mitral valve~     disease have been excluded from clinical trials of agents currently approved by the U.S. Food~     and Drug Administration (FDA) to treat PH. Therefore, this work will carefully characterize~     PA pressures in an objective manner in a group of patients following mitral valve surgery who~     remain limited with respect to their activity levels. In addition, the investigators will~     gain a better understanding of the frequency with which patients have PH and a normal PCWP,~     which identifies a cohort of patients who could have an improvement in their symptoms and~     quality of life with chronic vasodilator treatment.~   "
146697|NCT01646528|"~     The study aims to:~        1. Explore the properties of mesenchymal black spots, and to determine the value of~          mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser~          endomicroscopy (CLE).~        2. Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in~          patients with gastric mesenchymal black spot during CLE imaging.~   "
146698|NCT01646515|"~     The purpose of this study is to determine if udenafil improves exercise tolerance in patients~     with systolic heart failure.~   "
146777|NCT01645267|"~     In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected~     with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from~     the iliac crest to support the osteotomy. In the planned study a group of children will be~     operated with an artificial bone graft material and thus avoiding the need harvesting of bone~     graft at the iliac crest.~   "
146701|NCT01646476|"~     Malignant gastric outlet obstruction can result from gastric adenocarcinoma, leading to~     intractable vomiting, nausea, and poor oral food intake. Although self-expandable metallic~     stent (SEMS) insertion has excellent technical and clinical success rates for relieving~     gastric outlet obstruction symptoms, the uncovered SEMS is susceptible to re-stenosis because~     of tumor ingrowth through openings between the stent wire filaments. Therefore, the most~     common reason for stent failure in uncovered stents is tumor ingrowth.~      The covered SEMS has a membrane that prevents ingrowth through the mesh wall and consequently~     shows lower rate of re-stenosis than uncovered SEMS. However, covered SEMS has a higher risk~     of stent migration compared to uncovered SEMS. Recent prospective, randomized study showed~     that there was no significant difference between uncovered and covered SEMS in terms of stent~     patency rate as well as technical and clinical success rates.~      Recently the investigators developed new covered SEMS for gastric outlet obstruction. This~     new covered SEMS has features that may contribute to reducing migration rate: 1) partially~     covered design; 2)less radial force in central portion of stent; 3) presence of lasso which~     enable position of stent to be adjusted after deployment; 4)presence of protrusion in both~     sides of stent. This prospective, randomized study aimed to compare the effectiveness and~     side effects of newly developed covered SEMS with those of uncovered SEMS in patients with~     malignant gastric outlet obstruction from gastric cancer.~   "
146702|NCT01646463|"~     In the U.S., rates of preterm birth and low birth weight have increased over the past 30~     years. Poor birth outcomes are especially high among racial/ethnic minority populations.~     Maternal stress is an important factor that can lead to negative birth outcomes. Thus,~     programs that reduce stress during pregnancy could improve birth outcomes. Initial pilot work~     tested a mindfulness-based approach to stress reduction during pregnancy. Women in the pilot~     study had lower stress and improved coping after the program. For the current study,~     mindfulness is added to an existing prenatal healthcare program called CenteringPregnancy~     (CP). CP provides prenatal care through 10 group sessions. This study compares CP with a~     version of CP infused with mindfulness skills training. Effects of the two versions of CP on~     psychological stress and coping, stress hormones, and birth outcomes will be tested. Data~     will be collected from participants three times: twice during pregnancy and once after birth.~     Medical records will provide data on birth outcomes and other health factors. The study will~     provide initial information about a mind-body program to reduce stress and improve birth~     outcomes. Data from the study will inform the development of an R01 proposal for a larger~     study. The study will also help advance the long term goal of reducing health disparities.~   "
146703|NCT01646450|"~     A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as~     first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC~     and mutated EGFR.~   "
146704|NCT01646437|"~     The randomized 2x2x2 factorial design placebo controlled trial will enroll 5000 participants~     (women 60 years or older and men 55 years or older) without known heart disease or prior~     stroke and without a clear indication or contraindication to any of the study medications.~     Eligible and consenting individuals will be randomized to receive either the active study~     medications or placebo (dummy pills) and will be monitored for an average of 5 years. The~     study will include people from at 10 countries, will be conducted by an international group~     of scientists and physicians and will be coordinated by the Population Health Research~     Institute at Hamilton Health Sciences.~   "
146705|NCT01646424|"~     The aim of this study is to describe patient preferences on budesonide/formoterol fix dose~     combination for the treatment of their COPD, and to find those factors more strongly~     associated to a better attitude to medication.~   "
146706|NCT01646411|"~     For the development of a Point of Care IVD test kit for acute phase disease detection against~     a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed~     positive and 200 clinically normal serum and whole blood matched specimens for specificity~     and sensitivity determination for each marker. The positive samples must be IgM positive~     using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.~   "
146707|NCT01646398|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a~     single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of~     23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.~   "
146708|NCT01646385|"~     This study will assess the rates of serious adverse events and death in adult rheumatoid~     arthritis patients treated with etanercept over the long-term in real-life clinical practice.~     It will also assess whether there is any difference in the rate of serious adverse events in~     patients trated with etanercept in comparision to patients treated with conventional~     disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition quantify the~     efficacy of etanercept in this population by assessing the rates of important clinical~     outcomes such as changes in disease activity and disability/functioning.~   "
146709|NCT01646372|"~     The purpose of this study is to investigate whether formal instruction on the use of~     cognitive aids in managing a crisis will result in better longterm retention of knowledge and~     skills. In particular, this study examines the impact of cognitive aid teaching on the~     Advanced Cardiac Life Support course.~   "
146710|NCT01646359|"~     In patients under mechanical ventilation, Usefulness of dynamic indices based on the~     heart-lung interactions for guiding volume resuscitation has been well validated. Recently,~     validity of pulse pressure variation (PPV) has been also reported to predict fluid~     responsiveness. Oesophageal Doppler (OED) allows continuous monitoring of several important~     hemodynamic variables. Of the OED variables, corrected flow time (FTc) has been evaluated and~     used as a preload index, and has been reported to predict fluid responsiveness. Prone~     position caused physiologic and hemodynamic changes and influenced the predictability and~     cut-off values of SVV and PPV for fluid responsiveness. In this prospective controlled study,~     the investigators evaluated the validity of PPV and FTc as predictors for fluid~     responsiveness in supine and prone position in patients undergoing posterior lumbar spinal~     fusion~   "
146711|NCT01646346|"~     The Purpose of this study is to evaluate the feasibility of using image guidance and~     four-dimensional computed tomography to reduce the volume of non target breast tissue that is~     treated with accelerated partial breast irradiation via the external beam technique.~   "
146778|NCT01645254|"~     The main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of the~     decoction of the aerial parts of Argemone mexicana (AM), administered in healthy volunteers.~   "
146712|NCT01646333|"~     This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving~     training compared to supportive therapy in individuals with Parkinson's Disease with Mild~     Cognitive Impairment (MCI) and their support persons. Participants will be randomly assigned~     to receive memory and problem solving training or supportive therapy for 2-months. A 6-month~     follow up evaluation will establish if benefits remain over time. Impact of these therapies~     on thinking abilities, physical health, and patient and support person ratings of thinking~     skills, mood and quality of life will be evaluated. The memory and problem solving training~     is hypothesized to result in greater improvements and/or stability of function on~     neuropsychological tests of attention, working memory, learning, and memory skills compared~     to the supportive therapy condition. Both conditions are hypothesized to result in improved~     mood and quality of life ratings.~      Results from this study will determine whether memory and problem solving therapies and~     supportive therapy are easily used by and beneficial for individuals with Parkinson's Disease~     and Mild Cognitive Impairment. If positive benefit is observed, information from this study~     will be used to further optimize these therapies for larger trials designed to evaluate the~     value of the therapies for individuals with Parkinson's Disease and their support persons.~   "
146713|NCT01646320|"~     The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple~     combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes~     after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of~     this treatment will also be studied.~   "
146714|NCT01646307|"~     This randomized, open label, parallel-group study is designed to investigate whether~     periprocedural intensive statin therapy with atorvastatin versus rosuvastatin administration~     before PCI and 30-day continuous intensive treatment is superior to usual care, in terms of~     cardiovascular events for Chinese elderly patients.~   "
146715|NCT01646294|"~     The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed~     and eliminated from the body, and how well it is tolerated, when given in three different~     tablet formulations (sustained release) once a day with and without food, and to compare the~     results with the profile of the YM178 immediate release formulation taken twice daily without~     food.~   "
146716|NCT01646281|"~     Atrial fibrillation (AF) is associated with decreased atrial contractility which is~     associated with stroke. Decreased contractility becomes apparent after cardioversion of~     atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved~     contractility immediately after cardioversion may prevent arrhythmia progression. In~     addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to~     convert atrial fibrillation to sinus rhythm and at the same time increase atrial~     contractility. The latter has not yet been shown in humans and is subject of the present~     investigation. Our hypothesis is that in humans the contractility of the atria is higher~     after administration of vernakalant compared to flecainide. If indeed vernakalant improves~     atrial contractility after cardioversion further studies into the effect on long-term~     arrhythmia progression and stroke prevention may follow.~   "
146717|NCT01646268|"~     The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious~     in Chinese subjects with early-stage idiopathic Parkinson's disease.~   "
146718|NCT01646255|"~     The primary objective of this study was to demonstrate that Rotigotine transdermal patch is~     efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an~     adjuvant therapy.~   "
146719|NCT01646242|"~     Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm.~     However, complete removal of diminutive polyps is required to prevent tumor recurrence and~     development of potential interval cancers. Currently, a variety of polypectomy techniques~     such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the~     removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there~     are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal~     of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare~     polypectomy with cold forceps polypectomy using double biopsy technique for removal of~     diminutive colorectal polyps.~   "
146720|NCT01646229|"~     Septic shock of intra-abdominal origin is likely due to Gram-negative bacteria or mixed~     pathogens and associated with high levels of endotoxin. The injury to the endothelium results~     in an increase of endothelial permeability, interstitial edema and release of nitric oxide~     (NO) that is a very potent vasodilatator. [6] Polymyxins obtained from the Gram-positive~     bacterium Bacillus polymyxa are antibiotics known for their ability to bind LPS in the outer~     membrane of the Gram-negative bacterial cell wall as well as free endotoxins with high~     affinity. Polymyxin-B has been shown to block the activation of cells by a wide variety of~     LPS. Studies converged to show an improvement in the treatment of septic shock by removing~     circulating endotoxin.Starting Polymyxin-B hemoperfusion during the operative time is to~     block the initiation of various deleterious biological cascades induced by endotoxemia such~     as systemic inflammation, disseminated coagulation disorders, and shock, leading to organ~     dysfunction and death.~   "
146721|NCT01646216|"~     The purpose of this study is to determine whether split belt or conventional treadmill~     training can be used to treat walking pattern deficits from stroke and to determine whether~     this improves gait asymmetry and metabolic efficiency.~   "
146722|NCT01646203|"~     A study to evaluate the safety and tolerability of IMC-TR1 in patients with advanced solid~     tumors, as well as gather evidence of anti-tumor activity.~   "
146723|NCT01646190|"~     Fast-track (FT) surgery is a multimodal, multidisciplinary-team approach to reduce~     perioperative surgical stress and injury after colorectal surgery, resulting in lower~     morbidity and enhanced recovery. As fast-track approach could probably be the most beneficial~     for senior patients to reduce postoperative morbidity and better preserve independency, only~     scarce information is available in senior population. Therefore a randomized controlled trial~     is initiated in our institution compare a senior dedicated fast-track approach to modern~     standard care after colorectal surgery.~   "
146724|NCT01646177|"~     This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to~     etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.~   "
146725|NCT01646164|"~     Dill is herbaceous and aromatic herb used in order to convenient and shorter labor in Iran.~     The objective of this study was to evaluate the effect of Dill seed on uterus contractions in~     active phase of labor.~   "
146727|NCT01646138|"~     Background:~      - A challenge study exposes a person to a disease and allows researchers to study the disease~     through the body's healing process. An influenza challenge study that looks at different~     amounts of the flu virus can provide more information on the smallest amount needed to cause~     an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy~     volunteers to see how the body responds to the virus.~      Objectives:~        -  To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate~          flu infection in a healthy adult.~        -  To study how the body s immune system responds to the virus.~      Eligibility:~        -  Healthy volunteers at least 18 years of age.~        -  Participants must be willing to remain in isolation for a minimum of 9 days.~      Design:~        -  Participants will be admitted to a hospital inpatient isolation unit. They will be~          screened with a physical exam and medical history. They will also have heart and lung~          function tests. Blood, urine, and nasal swab/wash samples will be collected.~        -  Participants will receive a single nasal spray of the flu virus. They will stay on the~          inpatient unit for at least 9 days.~        -  Participants will be monitored for the length of their stay. They will have frequent~          blood tests and other procedures as needed.~        -  Participants will be allowed to go home once they have had two negative tests for the~          virus. The tests will be given on two consecutive days....~   "
146728|NCT01646125|"~     The purpose of this study was to determine if AUY922 had superior efficacy when compared to~     chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.~      The primary purpose of this study was to compare the efficacy of AUY922, when administered~     i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients~     with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed~     resistance to EGFR TKI.~   "
146729|NCT01646112|"~     Background:~        -  Individuals have varying tolerances for receiving ambiguous information. However, not~          much is known about how ambiguous genetic testing information is received. Also, not~          much is known about how at-risk individuals internalize and process these results. More~          information is needed about how this information affects a person s life.~        -  Lynch Syndrome is a genetic condition that carries a high risk of colon cancer and other~          cancers. Individuals at risk for Lynch Syndrome can have genetic testing for it. The~          test may confirm a diagnosis and determine actions that can be taken. Results from~          genetic testing can also affect the perspectives of relatives who might also be~          affected. However, genetic testing can also produce variants of unknown significance~          (VUS). VUS are data that may not provide enough information to make decisions.~          Researchers want to study people who have received a VUS result for genetic testing for~          Lynch Syndrome.~      Objectives:~      - To learn more about the impact and experience of receiving a VUS for Lynch Syndrome genetic~     testing.~      Eligibility:~      - Individuals at least 18 years of age who have recently had a VUS result on a genetic test~     for Lynch Syndrome.~      Design:~        -  Participants will be asked to answer demographic questions. They will also have a 45- to~          60-minute phone interview.~        -  During the phone interview, participants will be asked a series of questions about their~          diagnosis. They will be asked about how they received the result and how they felt right~          after receiving it. They will also discuss who they have spoken to about the result.~   "
146730|NCT01646099|"~     This study is being done to evaluate the effectiveness of a Sun Protection Strategies~     internet-based program for kidney transplant recipients. Since the medication taken to~     preserve the kidney transplant puts kidney transplant recipients at increased risk of~     developing a sunburn as well a skin cancer, the program will help people learn how to~     practice effective sun protection for their condition.~   "
146731|NCT01646086|"~     To achieve the long term goal of strengthening behavioral weight loss programs, the purpose~     of this project is to test an enhanced, daily weight tracking instruction against the current~     standard of care (weekly weight tracking) and an alternative mode of care (no weight~     tracking).~      The investigators postulate that daily weight tracking will boost ongoing awareness of and~     engagement in dietary intake and physical activity monitoring, thus improving weight loss~     outcomes. The central hypothesis of the study is that daily weight tracking will improve~     weight loss processes and outcomes relative to less frequent weight tracking, without adverse~     effects.~   "
146732|NCT01646073|"~     A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate~     to severe plaque psoriasis.~   "
146733|NCT01646060|"~     Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood~     volume and blood loss of a patient during surgery, post operatively and/or in recovery. This~     monitoring device will identify baseline blood volume and relative changes in blood volume~     using a specific algorithm to compare and review data already monitored during surgery,~     displaying blood volume and blood loss in real-time.~   "
146734|NCT01646047|"~     This study will evaluate the effects of a novel multi-component dietary supplement on the~     visual function and retinal structure of patients with diabetes with both no diabetic~     retinopathy and mild to moderate diabetic retinopathy. This is a placebo-controlled trial and~     neither subjects nor examiners will know if any given subject is taking active supplement or~     placebo.~      The hypothesis is that the supplement will improve visual function and retinal structure in~     subjects on active supplement~   "
146735|NCT01646034|"~     This study investigates the effect of high-dose alkylating chemotherapy compared with~     standard chemotherapy as part of a multimodality treatment approach in patients with~     oligo-metastatic breast cancer harboring homologous recombination deficiency.~   "
146736|NCT01646021|"~     The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus~     temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at~     least 1 prior chemotherapy regimen.~   "
146737|NCT01646008|"~     The purpose of this study is to study the correlation between carbon dioxide measured by~     capnography at the enf of exhalation and arterial blood in COPD patients with nasal cannula~     in critical care unit.~   "
146779|NCT01645241|"~     The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in~     oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes~     donors . This study will be performed in egg recipients and donors but this type of treatment~     is meant to be implemented in fertility preservation patients~   "
146780|NCT01645228|"~     To validate the capability of non-invasive bio-image tests in prediction of significant~     coronary stenosis of symptomatic adults.~   "
146738|NCT01645995|"~     Specific policies on obesity reduction often include a recommendation to reduce sugar~     consumption as a means of lowering overall caloric intake. Reformulating processed foods~     (e.g. sugary products) is considered one of the key options for improving population diet.~     The implications of regular consumption of reformulated products are not fully understood.~     Previous studies have demonstrated that dietary compensation is common, although the extent~     is not fully elucidated. In addition to the perceived impact of sugar consumption on weight~     control, high sugar intake, specifically sucrose and fructose, has been implicated in the~     increase of plasma lipids and markers of insulin resistance. However to date no randomised~     controlled study has investigated whether the consumption of reformulated low sugar products~     as components of a habitual diet have a significant impact on plasma lipid, insulin or~     glucose concentrations within a free-living, non-diseased population. It is hypothesised that~     exchange of reformulated, low sugar food products for habitually consumed foods will result~     in dietary compensation and minimal weight change compared with unmodified products and will~     have little impact on plasma glucose, insulin and lipid levels.~   "
146739|NCT01645982|"~     The purpose of this study is to compare the changes measured by Somanetics Invos cerebral~     oximeter to the mean arterial pressure at brain level in patients having elective shoulder~     replacement surgery. The Somanetics Invos System measures and monitors the oxygen saturation~     (rS02) of blood in the brain tissues to help prevent brain injury or other complications. The~     investigators hypothesize that maintaining normocarbia and systemic mean arterial pressure at~     or above 70mmHg during general anesthesia in the beach chair position will decrease the~     number of cerebral deoxygenation events during the procedure.~   "
146740|NCT01645969|"~     This multicenter, prospective, observational study will evaluate the one-year outcomes in~     HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a)~     in Arm A of study ML22265. Data will be collected from each patient for up to one year~     post-therapy.~   "
146741|NCT01645956|"~     The importance of exercise for weight control is well documented; however if exercise results~     in an increase in food intake, the beneficial effect of exercise may not be seen. This study~     addresses a gap in the current literature and examines why some people eat more after~     exercise and why some people eat less and also examines whether these responses are~     consistent over time. Participants in this study will be asked to come to our center on 7~     different occasions over a 3-4 month period. The first visit will be an assessment visit~     where body weight and body composition will be measured, questionnaires will be completed,~     and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions~     with visits in each pair separated by 48-96 hours) the procedures will be nearly identical.~     Upon arrival at our center, participants will consume a meal replacement, complete a series~     of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be~     resting and 3 will be exercising). One hour following the exercise/resting session,~     individuals will be given access to a buffet of food, unaware that their food intake will be~     monitored. All food will be weighed and measured before and after the eating period and the~     amount of food consumed after each pair of exercise and resting conditions will be compared~     to one another. It is hypothesized that the difference in food intake will be consistent~     across pairs of testing sessions. Findings from this study will help us to better understand~     the relationship between exercise and food intake and may ultimately lead to future studies~     that can address the clinically significant question of why some individuals gain weight and~     others lose weight when engaging in exercise training programs. Findings from this study may~     also help to develop exercise programs that maximize the beneficial effect of exercise on~     body weight.~   "
146742|NCT01645943|"~     The guidelines of clinical practice, based on the randomized studies, recommend an invasive~     strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with~     comorbidities are excluded from the randomized studies and the observational registries~     showthat patients with comoribidities undergo fewer cardiac catheterizations. The aim is to~     investigate the benefit of the invasive strategy in patients with NSTEACS and comorbidities.~      Patients hospitalized with NSTEACS, older than 70 years and with significant comorbidities,~     will be included. The latter will be defined as at least 2 of the following: peripheral~     artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal~     failure and anemia. The included patients will be randomized to an invasive (routine coronary~     angiogram) or conservative (coronary angiogram only if recurrent or inducible ischemia)~     strategy. All patients will receive medical treatment according to current recommendations.~      The main outcome will be death, reinfarction or readmissions by heart cause at one-year~     follow-up. The hypothesis is that an invasive strategy will improve prognosis in patients~     with NSTEACS and comorbidities.~   "
146743|NCT01645930|"~     The purpose of this Phase 1 study is to characterize the Pharmacokinetic (PK) and~     tolerability of Oral IXAZOMIB when administered in combination with lenalidomide and~     dexamethasone in adult Asian patients with Relapsed and/or Refractory Multiple Myeloma~   "
146744|NCT01645917|"~     The purpose of the study is to determine the permanency of PV isolation with the Arctic Front~     Advance cryoablation system in paroxysmal AF patients. It will also provide data on acute~     procedural outcomes and measures as well as clinical AF recurrence in these patients~     approximately 3 months post-ablation.~   "
146745|NCT01645904|"~     The goal of this research study is to create an internet-based program designed to improve~     the communication of health and health history information among family members affected by~     Lynch syndrome.~   "
146746|NCT01645891|"~     The purpose of this study is to evaluate the safety and effectiveness of Continuous Diffusion~     of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers. The primary objective of~     this study is to evaluate the effectiveness of CDO in combination with standard moist wound~     therapy (MWT) on wound healing as compared to standard MWT alone.~   "
146759|NCT01645709|"~     This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the~     safety, tolerability, and efficacy of Intra-Articular (IA) verapamil in the treatment of~     joint pain in patients with knee osteoarthritis (OA). Subjects will discontinue all analgesic~     medications for the entire duration of the study, except for acetaminophen (taken on an as~     needed basis at no more than 2 g/day). At visit 2, subjects who meet all entry criteria will~     be randomized to receive a single injection of IA verapamil or IA placebo at a ratio of 1:1.~     Treatments will be given with fluoroscopy or ultrasound to confirm needle placement. Subjects~     will be monitored for blood pressure and heart rate (sitting and standing) for at least 1~     hour post-injection. Subjects will be evaluated at weeks 1, 2, 3, 4, 6, 8, and 12 after~     treatment.~   "
146760|NCT01645696|"~     The purpose of this study is to investigate the accuracy and performance of a new~     subcutaneous continuous glucose monitor (BD-CGM, Becton Dickinson) in hyperglycemic (high~     blood sugar) and hypoglycemic (low blood sugar) clamp conditions and during meal excursions~     over the course of 72 hours as compared to a commercially available monitor.~   "
146747|NCT01645878|"~     Exclusive breastfeeding is very important for an infant's growth and development.~     Self-efficacy is a modifiable psychological variable in sustained breastfeeding that is~     defined as a mother's confidence in her perceived ability about successful exclusive~     breastfeeding. Self- efficacy beliefs function as an important set of human motivation ,~     affect , and action which operate on action, through motivation, cognitive and affective~     interventing process. teaching strategies ,based on Bandura,s self-efficacy theory and adult~     learning principles were incorporated in this research design. In regards with the importance~     of education in increasing breastfeeding self-efficacy and exclusive breastfeeding, the~     current study was conducted in order to compare of the effectiveness of two educational~     methods, i.e., Hands on and Hands off on breastfeeding self-efficacy in primiparous~     mothers.~      In the present clinical trial, 136 nursing mother were randomly assigned to one of the three~     groups. Participants in the experimental groups received one of the structured one-on-one~     educational sessions (i.e., hands off or hands on) within the first two hours of giving~     birth. Mothers in control group received usual postpartum care. Follow-up assessments were~     conducted one, four, and eight weeks after the birth. Data collection was done through~     interview forms, examination and observation, checklist of breastfeeding status,~     breastfeeding self-efficacy and daily-feeding form.~   "
146748|NCT01645865|"~     Although gains have been made in achieving the health-related Millennium Development Goals~     (MDG), much is still needed in countries affected by high levels of HIV/AIDS. Prevention of~     mother-to-child transmission (PMTCT) is a cornerstone strategy in reducing infant mortality~     from HIV. The study will employ a cluster randomized control trial (cRCT) with 26 health~     facilities randomized to two arms (intervention or control) to determine the effect of mobile~     phone technology on completion of key PMTCT milestones from antenatal to six weeks~     postpartum. The study will examine the acceptability, effectiveness, and cost of implementing~     a PMTCT-focused mHealth strategy among HIV-infected pregnant women, health workers, and male~     partners.~   "
146749|NCT01645852|"~     The purpose of this study is to measure the effect of a short-term low calorie diet on~     patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.~   "
146750|NCT01645839|"~     The purpose of this study is to compare the neurological progression free survival with the~     use of an intrathecal chemotherapy with liposomal cytarabine (DepoCyte®) in leptomeningeal~     metastasis of breast cancer (versus no intrathecal treatment).~   "
146751|NCT01645826|"~     The purpose of this study is to determine if cardizem is effective in the treatment of nitric~     oxide non-responder pulmonary arterial hypertension.~   "
146752|NCT01645800|"~     The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks~     lysozyme administration in patients with COPD.~   "
146753|NCT01645787|"~     The purpose of this study is to assess whether 4-AP (Dalfampridine-ER, Ampyra) improves~     walking ability and endurance in adult patients with Spinal muscular atrophy (SMA) Type 3~     compared to placebo and whether the duration of treatment affects outcome.~   "
146754|NCT01645774|"~     Subcutaneous heparin injection is one of the most frequent nurses' clinical care. This study~     aimed to Identify and compare the effects of four different injection duration on pain and~     bruising associated with subcutaneous injection of heparin in 90 patients. Four injection~     methods were used for them:~      A: 10s injections duration~      B: 10s injection duration and waiting 10s before withdrawing the needle~      C: 15s injection duration and waiting 5s before withdrawing the needle~      D: 5s injection duration and waiting 15s before withdrawing the needle.~      Bruising was measured by a flexible millimeter ruler 48h after each injection; and pain was~     measured by pain visual analogue scale immediately after the injection. Data will be analyzed~     by SPSS.~   "
146755|NCT01645761|"~     Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a~     reduction in mucus viscosity. As part of the search for more effective forms of therapy~     against H. pylori when it colonizes not only the surface of the surface mucosal cells but~     also the surface mucous gel layer covering the mucosal surface of the stomach. The~     investigators decided to investigate whether or not endonase might have additive effect of~     pronase on the efficacy of eradication therapy against Helicobacter pylori.~   "
146756|NCT01645748|"~     The purpose of this study was to evaluate the tolerability and efficacy of a combination of~     weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy in patients with~     locally advanced head and neck squamous cell carcinoma (HNSCC).~   "
146757|NCT01645735|"~     The purpose of this study is to determine whether ceftaroline is effective and safe for the~     treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for~     infection due to Methicillin-resistant Staphylococcus aureus (MRSA).~   "
146758|NCT01645722|"~     The objective of this pilot study is to assess the efficacy of minimally invasive autologous~     fat transfers at the amputation sites and the modulation of pain at the respective sites. Our~     investigators hypothesize that autologous fat grafting can provide a minimally invasive~     therapy to effectively mitigate pain syndromes at amputation sites, by introducing volume~     stable subcutaneous tissue over bony prominences and peripheral nerve trunks, thereby~     avoiding major surgical revisions and preserving limb length. The investigators further~     hypothesize that enriching the fat graft with autologous adipose stromal cells, a~     regenerative medicine approach, will lead to improved retention of the fat graft over time~     and result in a more favorable outcome.~      The Investigators will evaluate:~        1. Treatment of painful amputation sites in 5 patients with fat grafting, intended to~          provide additional subcutaneous tissue padding over bony structures and nerve trunks.~          Limb anatomy and healing of the graft over time, along with stability/persistence of the~          new tissue, will be assessed by high resolution CT scanning with 3D reconstruction.~          Patients will be followed for 24 months after treatment to define long term outcomes.~          Patients will be enrolled who have pain at an amputation site that limits function~          and/or interferes with the ability to use a prosthesis.~        2. Biologic properties of the cells within the fat graft and correlate with clinical~          outcomes. This will include adipose stem cell yield per volume of fat tissue, cell~          proliferation, capacity for adipogenic differentiation, lipolysis, and cell~          sub-population analysis by multiparameter flow cytometry. Results of these assays will~          be correlated with graft volume retention to search for predictors of good clinical~          outcome that are related to variation on adipose biology between subjects.~        3. Quality of life measurements in patients before and after autologous fat grafting using~          validated psychosocial measures. This will include SF 36, the Beck inventory, and~          instruments designed for assessing limb function.~   "
146761|NCT01645566|"~     This is a prospective randomized controlled study. The aim of this study is to~        1. describe the stress patterns experienced during a CPR situation;~        2. investigate whether the perceived stress was associated with CPR performance in terms of~          hands-on time and time to start CPR;~        3. to investigate whether this task focusing strategy reduces perceived stress levels, and~        4. whether this translates into better CPR performance. Based on findings that clear,~          directive leadership can enhance performance in cardiac resuscitation, we further 5)~          investigate if stress was associated with fewer leadership statements.~   "
146762|NCT01645475|"~     Nocturnal enuresis affects 10% of the 7-year-old children and is essentially caused by a~     mismatch between nocturnal bladder capacity and the amount of urine produced during the night~     together with failure of the child to awaken in response to a full bladder.Urine~     overproduction at night or nocturnal polyuria (NP) is a major factor contributing to~     monosymptomatic nocturnal enuresis (MNE) pathophysiology in a large proportion of patients.~      Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion,~     the synthetic AVP analogue desmopressin is widely used to treat MNE.~      It is recommended by the International Consultation on Incontinence (grade A,level 1).~     Desmopressin is available in 3 different formulations: nasal spray, tablet and the newest~     form melt.~      Baeyens et al demonstrated an increased prevalence of attention deficit-hyperactivity~     disorder (ADHD) in children with MNE According to recent data there is a high incidence of~     periodic limb movements in sleep at night in children with nocturnal enuresis. Those children~     have an increased cortical arousability leading to awakening.~      The frequent awakening most likely has an influence on concentration and other ADHD-symptoms~     in daily life.~      This study will assess the impact of desmopressin melt on prepulse inhibition, ADHD-symptoms,~     cognition and learning, sleep, quality of life and self esteem.~      New patients aged 6-16 years with monosymptomatic nocturnal enuresis, nocturnal polyuria and~     sleep problems are tested before the start of the study medication desmopressin melt (T1) and~     6 months later (T2). It is a multi-method, multi-informant study.~   "
146763|NCT01645449|"~     The purpose of this study is to compare and evaluate the single-dose oral bioavailability and~     to monitor the safety of subjects.~   "
146764|NCT01645436|"~     The aim of this randomized controlled trial on Physical Activity and Pediatric Cancer (PAPEC)~     is to assess the impact of an exercise program intervention in pediatric cancer patients~     undergoing chemotherapy for solid tumors. The investigators hypothesized the intervention~     will have a beneficial effect on the study outcomes.~   "
146765|NCT01645423|"~     The purpose of this study is to compare and evaluate the single-dose oral bioavailability and~     to monitor the safety of subjects.~   "
146766|NCT01645410|"~     The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg~     of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland~     Pharmaceuticals in healthy, adult, human subjects under fed condition.~   "
146767|NCT01645397|"~     The purpose of this study is to assess if in steroid naïve asthmatic children with elevated~     baseline exhaled nitric oxide, treatment with inhaled steroid and normalization of exhaled~     nitric oxide level results in restoration of the bronchodilator response to deep inhalation.~   "
146768|NCT01645384|"~     The purpose of this study is to monitor clinical status, adverse events and laboratory~     investigations and assess relative safety and tolerance of Atorvastatin formulations under~     fasting conditions.~   "
146769|NCT01645371|"~     This qualitative research is to assess the validity of the stool symptom screener that will~     be used in patients with chronic opioid-induced constipation to determine the adequacy of~     their response to laxatives.~   "
146770|NCT01645358|"~     Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation~     (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic~     Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory~     failure, it is largely employed as a rotating strategy when the facial mask is poorly~     tolerated.~      In a multicenter randomized controlled trial, the investigators will compare the clinical~     efficacy of a new helmet designed to specifically improve the performance in chronic~     obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.~   "
146771|NCT01645345|"~     To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the~     treatment of acne scars and wrinkles.~   "
146772|NCT01645332|"~     This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with~     12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic~     control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and~     2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin~     level, lipid profile, and body weight.~   "
146773|NCT01645319|"~     The primary objectives of the study are:~        1. To compare the proportion of patients who achieve a successful response to treatment~          (reduction in Intraocular Pressure (IOP) of >15%) between patients treated with laser~          surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty) with~          patients receiving additional medications, at 1-year post-treatment initiation.~        2. To compare the proportion of patients who achieve a successful response to treatment~          (reduction in IOP of >15%) between patients treated with other procedures (including~          incisional surgery, drainage device procedures, and other glaucoma procedures) with~          patients receiving additional medications, at 1-year-post-treatment initiation.~      The study is a prospective, observational cohort study and will not provide or recommend any~     treatment. Patients who have failed initial medical therapy with two glaucoma medications~     will be identified and enrolled at the time of scheduling of a laser surgery procedure or~     other procedure such as incisional surgery or drainage device, or initiation of an additional~     course of therapy with medication as determined by their physician. This inception cohort of~     new initiators of laser surgical treatment, other procedures, or additional medical therapy~     will be followed for 12 months. All decisions regarding treatment are solely at the~     discretion of the physician in accordance with their usual practice. Enrollment is expected~     to begin in February 2011 and continue through 12 months of follow-up after enrollment~     targets have been reached.~   "
146774|NCT01645306|"~     Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks~     (TIAs), amaurosis fugax or stroke receive either Revacept (single dose) plus antiplatelet~     monotherapy or monotherapy alone.~      Patients receive a single dose of trial medication by intravenous infusion for 20 minutes.~     Patients are followed up one and three days after treatment, at 3 months and by a telephone~     interview at 12 months.~   "
146775|NCT01645293|"~     Patients with cutaneous CD30 positive lymphoma will receive systemical and topical treatment~     with their own genetically modified T cells. Treatment evaluation consists of assessment of~     safety and preliminary evidence of response.~   "
147308|NCT01638286|"~     A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a~     pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy~     male subjects.~   "
146781|NCT01645215|"~     Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular~     endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent~     inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted~     to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the~     pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-013 at single doses and~     multiple doses .~   "
146782|NCT01645202|"~     A randomized controlled multicenter study comparing the acute hemodynamic performance of the~     Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk~     patients with severe symptomatic aortic stenosis.~   "
146783|NCT01645189|"~     The objective of this study is to determine the safety and efficacy of once weekly dosing of~     idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome~     patients < 6 years old.~   "
146784|NCT01645176|"~     The purpose of this study of a combination therapy of hydroxychloroquine and atorvastatin is~     to learn about the effects in inflammation and pain in patients with Osteoarthritis of the~     knee. These medications are FDA approved and commercially available.~   "
146785|NCT01645163|"~     The study aims to develop, design pilot a mHealth intervention strengthen complementary~     feeding (CF) components of the ICDS program.~      The methods will include explaining views of caregivers of infants aged 9-11 months, AWWs and~     other ICDS personnel on the feasibility, acceptability and the best means of using mobile~     phones to deliver CF counselling. Based on the feedback an intervention will be developed and~     pilot tested.~   "
146786|NCT01645150|"~     The purpose of this pilot study is to determine the effects of a 12-week resistance training~     program on cancer related fatigue in cancer patients receiving tyrosine kinase inhibitor~     (TKI) therapy. It is hypothesized that incidence and severity of cancer related fatigue can~     be reduced by exercise training in this population which leads to an improved treatment~     completion rate.~   "
146787|NCT01645137|"~     The use of complementary and alternative medicine in neonatal ward has been steadily rising~     during the last decade. This integrated medicine approach has been shown to be helpful to~     improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to~     premature infants to reduce the length of stay and to cope with clinical complications.~     Results from previous studies documented the positive association between OMT and shorter~     period of hospitalisation as well as improvement of clinical conditions. The aim of this~     nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in~     premature infants across 3 neonatal intensive care units (NICU).~   "
146788|NCT01645124|"~     CYTO-PV is a phase III Prospective, Randomized, Open-label, with Blinded Endpoint evaluation~     (PROBE), multi-center, clinical trial in patients with diagnosis of Polycythemia vera (PV)~     treated at the best of recommended therapies (e.g.adequate control of standard cardiovascular~     risk factors). Irrespective of randomized interventions, all patients will be administered~     low-dose aspirin (when not contraindicated), i.e.the standard antithrombotic treatment in PV~     patients.~      The purpose of this study to demonstrate that a more intensive cytoreductive therapy, plus~     low-dose aspirin when not contraindicated, with phlebotomy and/or hydroxyurea (HU), aimed at~     maintaining hematocrit (HCT) < 45% is more effective than a less intensive cytoreduction~     (either with phlebotomy or HU plus low-dose aspirin when not contraindicated) maintaining HCT~     in the range of 45-50% in the reduction of CV deaths plus thrombotic events (stroke, acute~     coronary syndrome [ACS], transient ischemic attack [TIA], pulmonary embolism [PE], splanchnic~     thrombosis, deep vein thrombosis [DVT], and any other clinically relevant thrombotic event),~     in patients with Polycythemia Vera treated at the best of recommended therapies (e.g.~     adequate control of standard cardiovascular risk factors).~   "
146789|NCT01645111|"~     The current study would prospectively evaluate the dosing requirements, efficacy and safety~     of clevidipine for controlled hypotension during spinal surgery in the pediatric population.~     As the investigators currently have projects underway which include those patients having~     scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing~     scoliosis surgery for neuromuscular disease.~   "
146790|NCT01645098|"~     This is an interventional study on Duchenne muscular dystrophy patients who will be receiving~     sedation for a muscle biopsy as part of another study.~   "
146791|NCT01645085|"~     A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different~     Formulations of Fostamatinib.~   "
146792|NCT01645072|"~     Epilepsy is a frequent cause of morbidity in the pediatric age group. Many catastrophic~     epilepsies present during infancy and childhood1. Seizures in these epileptic disorders are~     difficult to control; sometimes only at the expense of multiple and toxic levels of~     antiepileptic medications. The shortcomings of antiepileptic drug therapy and epilepsy~     surgery warrants the need for alternative treatments. Ketogenic diet is effective for~     refractory epilepsies (33% of patients with refractory epilepsy have more than 50% reduction~     in seizures from the baseline and 15-20% become seizure free) and has gained widespread~     acceptance. Low glycemic index diet treatment (LGIT) is designed as a variant of ketogenic~     diet. There are retrospective studies on LGIT in childhood refractory epilepsy reporting~     seizure reduction comparable to that of patients on ketogenic diet. There have been no~     randomized controlled trials assessing the efficacy of the low glycemic index diet in~     refractory epilepsy. In this study we plan to assess the efficacy of LGIT among children with~     drug refractory epilepsy.~   "
146793|NCT01645059|"~     This is an observational, cross-sectional study that the main objective is to describe the~     patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a~     metastasis after or during the adjuvant treatment.~   "
146794|NCT01645046|"~     The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a~     natural hypolipidemic compound, coenzyme A （CoA） capsule in Chinese patients with moderate~     dyslipidemia.~   "
146845|NCT01644383|"~     Logotherapy has never been evaluated in HIV-infected teenagers. In this study, we will~     evaluate the meaning of life by using The Purpose in Life Test and the affect of logotherapy~     in HIV infected youth at HIV-NAT, Thai Red Cross AIDS Research Centre and King Chulalongkorn~     Memorial Hospital.~   "
146846|NCT01644370|"~     To explore allergen-specific effector and regulatory T cell response in HIV-infected children~     before and after HAART initiation~   "
146795|NCT01645033|"~     The purpose of this study is to determine if a computerized version of Cognitive Behavioral~     Therapy (CBT) can improve high-risk sexual behaviors in patients attending an outpatient~     methadone treatment clinic. This population is at high risk for contracting and spreading~     hepatitis and HIV. When added to their treatment as usual (TAU), the CBT session will~     increase the total exposure of clients to education about how to reduce risky sexual and~     needle use behaviors and provides real world examples. This study seeks to determine if the~     use of this CBT program is easily added into the clinical program and if patients are~     satisfied with its use.~      The main hypothesis is that the use of computerized CBT in addition to treatment as usual~     will improve knowledge and reduce occurrences of unprotected sexual activity. The study will~     also look at patient and clinic costs related to the CBT intervention, drug use and~     retention/adherence.~   "
146796|NCT01645020|"~     Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer~     postoperative complications especially less pain caused by the mesh mass.~   "
146797|NCT01645007|"~     Primary Aims:~        1. Evaluate HBV (Hepatitis B Virus) infection prevalence among Druze in the Galilee.~        2. Educate the population in order to reduce transmission~        3. Increase awareness among primary care providers~      Secondary Aims:~        1. Identify chronic HBV infected patients who need to be followed and treated,~        2. Identify HBV infected women in a childbearing age~        3. Identify non immunized individuals and recommend vaccination~        4. Identify previously vaccinated individuals who are not immunized~        5. Identify previously vaccinated individuals who became infected~      Study Design:~      Study population is targeted to native Israeli Druze. We aim for evaluating up to 20,000~     people from Druze communities in the Galilee area~      This work will be divided into three sections:~        1. Increasing awareness: lectures and local events will be taken place in the communities.~          Written information will be given and primary care-providers mainly family doctors,~          nurses and obstetric surgeons will be involved.~        2. All participants, upon signing a consent will:~             -  Fill up a questioner~             -  Checked for weight, height and waist circumflex~             -  Have a blood sample taken~        3. Results and recommendations will be forwarded to all participants~   "
146798|NCT01644994|"~     The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin)~     combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural~     pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by~     evaluation of the safety in a dose-escalating model (phase I), and confirmation of safety and~     efficacy in phase II with the maximum tolerated dose in phase I.~   "
146799|NCT01644981|"~     Serial quantitative measurements of plasma pro-endothelin-1 concentrations in very preterm~     infants. Comparing pro-endothelin-1 with established clinical indices of bronchopulmonary~     dysplasia (BPD). Hypothesis: Pulmonary-vascular remodeling in infants developing BPD is~     directly related to circulating pro-endothelin-1, which therefore serves as surrogate marker~     of BPD.~   "
146800|NCT01644968|"~     This study is designed to determine the safety and highest tolerated dose of anti-OX40 in~     patients with advanced cancer.~   "
146801|NCT01644955|"~     This study is being done to evaluate the toxicity and safety of carboplatin administered by~     convection enhanced delivery into the tumor in patients with high grade glial neoplasms. This~     study is a dose escalating study, (the dose of the study drug is increased at set time~     points). Carboplatin is in a class of drugs known as platinum-containing compounds; it slows~     or stops the growth of cancer cells in your body. Convection enhanced delivery involves~     placing one or more catheters into the brain and delivering chemotherapy through those~     catheters directly into the brain~   "
146802|NCT01644942|"~     The study aims to determine in obese patients the implication of intramuscular lipid~     accumulation in relation with insulin resistance and defect in lipid oxidation.~   "
146803|NCT01644929|"~     Rehabilitation after stroke improves motor functions by promoting plastic changes however,~     after completing standard rehabilitation, 50-60% of patients still exhibit some degree of~     motor impairment and require at least partial assistance in activities of day living.~     Therefore, the exploration of other approaches to promote recovery is compulsory. Non~     invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms~     in inducing neuroplastic changes in the human cortex and an emerging field of research is~     focusing on the possibility of coupling both therapies in order to achieve an additive effect~     and improve outcome.~      We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS)~     with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke~     patients may improve upper limb motor recovery in humans.~      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.~     Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers~     of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer~     Assessment Upper Extremity according to the severity of the deficit, the patient will be~     randomized to receive besides standardized physical/occupational treatment according to the~     Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12~     patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of~     treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3~     (12 patients) will receive routine physical/occupational treatment and sham tDCS for six~     weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months.~     Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index,~     the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip~     strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at~     month 6 depression will be assessed by the Hamilton depression Rating Scale.~   "
146817|NCT01644747|"~     The aim is to investigate the effect of transcranial Direct Current Stimulation (tDCS)~     applied at the anodal left CDLPF of patients with resistant depression compared to patients~     treated with conventional therapy. The tDCS is used in add-on drug treatment in resistant~     depression stabilized for 4 weeks (antidepressant as SSRIs (Selective Serotonin Reuptake~     Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients~     and lithium for bipolar patients). The delay of 4 weeks is a minimum to observe a~     non-response. Moreover, in term of ethical point of view, it's difficult to wait 6 to 8 weeks~     to observe the non-response to treatment.~      This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients (48~     unipolar plus 12 bipolar patients per group. Patients will be selected in the psychiatric~     department of the University Hospital of different centers and the two groups are matched for~     age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).~      After giving informed consent, patients will be evaluated by a psychiatrist using the~     Hamilton Depression Rating Scale (HDRS), Montgomery Asberg Depression Rating Scale (MADRS),~     the STAI and Beck Depression Inventory (BDI) and for bipolar patient only, by the Young Mania~     Rating Scale (YMRS). The complete assessment takes 50 minutes. A neuropsychologist assessment~     will be also realized during 20 minutes using the Crossing of Test (COT), the Trail Making~     Test (TMT), the Isaacs Set Test (IST) and the Cardebat fluency Task.~      After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will~     be directed by 30-minute session. A psychometric assessment will be conducted again at the~     end of treatment week and 4, 12 and finally 24 weeks after stopping treatment. The~     neuropsychologist assessment will be conducted again 4 weeks after the end of treatment.~     Scales of comfort and acceptability will also be proposed to the patient to determine whether~     any gene is caused by this treatment.~      These people will be recruited on a voluntary basis, after notification and consent in the 6~     research centers. This study was conducted over a period of 36 months.~      This study was supporting by a grant from the French Hospital Program of Clinical Reseach~     (PHRC N/2011-60-2011-A01074-37)~   "
146804|NCT01644916|"~     Chronic obstructive pulmonary disease (COPD) stands out among chronic diseases with its high~     and rising prevalence and mortality, poor quality of life, high re-hospitalization rates and~     societal burden of care. Current therapeutic and management practices are generally met with~     limited success. Research in recent years have highlighted the high level of psychiatric~     co-morbidity in COPD patients, and the major prognostic significance of anxiety/depression in~     COPD outcomes such as re-hospitalization, smoking cessation, quality of life, and survival.~     This suggests that addressing psychiatric and psycho-social aspects of care prominent in COPD~     patients may have strongly positive impact on outcomes, but the available evidence of~     effectiveness is limited.~      The primary aim of the proposed research is to evaluate the effectiveness of a holistic~     disease management paradigm of psychiatric liaison consultation (CL) that integrates~     psychiatric and respiratory care to improve outcomes for COPD patients. This integrated~     psychiatric consultation liaison (IPCL) management paradigm includes the routine screening~     and structured collaborative care of anxiety and major depressive symptoms and~     depressive/anxiety disorder in COPD patients. We postulate that the IPCL care paradigm would~     reduce mood symptoms, increase smoking quit rates, reduce symptom burden and functional~     disability, and improve quality of life, while reducing rehospitalization, emergency~     department (ED) and unscheduled physician visits. A secondary aim is to evaluate its cost~     effectiveness by concurrently collecting resource utilization data.~   "
146805|NCT01644903|"~     This study is being done to test blood, urine and tissue samples to see if this can help~     decide if CKD (Chronic Kidney Disease), AR (Acute Rejection) and HCV (Hepatitis C Virus) can~     be identified in its early stages. CKD damage to the kidneys, AR and HCV all lower the body's~     ability to function properly. Early detection of these conditions could assist with~     successful treatment and possibly lead to less repeat organ transplants.~   "
146806|NCT01644890|"~     To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to~     paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent~     breast cancer.~   "
146807|NCT01644877|"~     This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen~     and diagnosed with a parainfluenza infection.~   "
146808|NCT01644864|"~     This is a prospective randomized double-blind placebo controlled study (0.375% Ropivacaine~     vs. 0.9% saline) designed to evaluate the effectiveness of transverse abdominis plane (TAP)~     block in the first 48 hours after c-section in patients receiving methadone therapy. The TAP~     block will be performed by a regional anesthesiologist in the operating room after delivery~     of the baby.~   "
146809|NCT01644851|"~     The purpose of this pilot study is to determine the effects of computer-based training in~     executive functioning compared to word games on cognitive and emotional aspects of~     combat-related PTSD.~   "
146810|NCT01644838|"~     It is always considered to shorten the duration of delivery without compromising the mother~     and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research~     is very limited, with conflicting results regarding the efficacy of these two drugs. So the~     investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on~     length of active phase of the first stage of labor.~   "
146811|NCT01644825|"~     The purpose of this study is to evaluate the safety and activity of adding pazopanib to~     weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or~     refractory to treatment with platinum based therapy.~   "
146812|NCT01644812|"~     This two-site (Southern Methodist University (SMU) and Boston University (BU)) study aims to~     examine the effectiveness of exercise interventions for the treatment of generalized anxiety~     disorder (GAD). If effective, the use of exercise as a component of treatment for GAD would~     have a significant public health impact. In addition to improving GAD treatment outcome,~     exercise is expected to offer health benefits and promote further lifestyle changes.~      The present study involves the randomization of 52 adults with GAD to either a 12-week~     combined supervised- home-based moderate-intensity aerobic exercise protocol (EX) or a~     12-week combined supervised- home-based stretching protocol (CTRL). The investigators~     hypothesize that participants in the EX intervention will evidence greater improvements in~     anxiety symptoms and quality of life relative to individuals receiving the control~     intervention.~   "
146813|NCT01644799|"~     Biologic therapies, such as lenalidomide, may stimulate the immune system in different ways~     and stop cancer cells from growing. Idelalisib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. This phase I trial studies the side~     effects and the best dose of lenalidomide when giving together with idelalisib in treating~     patients with recurrent follicular lymphoma.~   "
146814|NCT01644786|"~     The purpose of the biobank is to enable future genomic based research on this Head and Neck~     Cancer patient population. The investigators will try to identify tumor factors that will~     predict cancer-related outcome in order to improve the outcome prediction after treatment in~     a patient-individualized manner.~   "
146815|NCT01644773|"~     This is a phase I study to find the highest tolerable dose of crizotinib and dasatinib given~     in combination to patients with diffuse intrinsic pontine glioma (DIPG) and other types of~     high grade gliomas (HGG). Participants will receive escalating doses until the highest dose~     is determined. Participants will be enrolled in two strata: stratum A for recurrent/~     progressive tumors and stratum B for recently diagnosed patients who have completed standard~     radiation therapy without progressive disease. Up to 7 dosage levels will be tested. Both~     drugs are taken orally daily, once per day. Correlative pharmacokinetic and biology studies~     are planned, as well as advanced methods of magnetic resonance imaging (MRI).~   "
146816|NCT01644760|"~     The main objective of this study is to determine a threshold value of diaphragmatic excursion~     (ultrasound measures: expiration versus inspiration)that best predicts a 50% collapsibility~     of the inferior vena cava.~   "
146818|NCT01644734|"~     To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH~     maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the~     real life setting of COPD patients, previously treated with short-acting bronchodilator on~     regular or as-needed basis.~   "
146871|NCT01644032|"~     The aim of the study is to evaluate the safety and efficacy of telemedically supported and~     delegated pain therapy in the Emergency Medical Service (EMS).~   "
146872|NCT01644019|"~     The aim of the study is to investigate the quality of prehospital emergency care in acute~     stroke, when paramedics are supported telemedically by an EMS physician.~   "
146819|NCT01644721|"~     Background: All observational studies and a few randomised controlled trials (RCT) suggest~     that early measles vaccine (MV), in particular an early two-dose strategy, has a much better~     effect on overall mortality than later MV. These results suggest that MV has a non-measles~     related beneficial effect on child survival.~      Objective: To evaluate in a two-site RCT the effect on child survival and other health~     indicators of a two-dose measles vaccination schedule by providing an additional dose of~     Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard~     measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina Faso.~     The investigators will test a 40-43% reduction of mortality at each site separately and a 32%~     reduction overall. Based on the results from the RCT, the investigators will assess the~     cost-effectiveness of the intervention.~      Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance~     System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations~     will be collected regularly through home visits and health centre registers. Four weeks after~     having received the third dose of pentavalent vaccine (Penta3), the children will be eligible~     for enrollment in the trial if they are not severely ill. Eligible children will be invited~     to take part in the trial. Provided parental informed consent is given, the children will be~     randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based~     on consumption of services and average cost per unit. The incremental cost effectiveness~     ratio will be calculated.~      Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each~     site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The~     children will be followed for survival and hospitalisations to 3 years of age or to the end~     of the study after three years. The investigators will analyse the effects by site and~     combined; by sex and season; possible interactions with other interventions like campaigns~     with drugs, vaccines or micronutrients will be explored.~      Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of~     maternal antibody levels on subsequent antibody responses to MV. The children will be~     followed to 24 months of age and samples collected at 4, 9 and 24 months of age.~   "
146820|NCT01644708|"~     Overweight and obesity put an heavy burden over people's health. Many methods are reported in~     medical literature but none of them proved to be effective in maintaining the results~     achieved over time. Motivational change remains a fundamental step towards the maintenance of~     a new lifestyle. Strengthening personal capabilities and self-esteem seem to be key~     strategies in motivating persons for change and facilitating a capacity of coping.~      The aim of this study is to observe the effects of an individual empowerment program on the~     health of a group of overweight/obese persons.~   "
146821|NCT01644695|"~     Abdominal wall incisional hernia is a common finding in patients who have undergone previous~     intra-abdominal surgeries. Common methods of abdominal fascial closure include primary~     closure, mesh inlay versus onlay, with or without component separation. All these methods~     have been shown to have recurrence rates for hernia between 3%-60% in the literature. The~     study describes the investigators innovative and preferred method for reconstruction of the~     abdominal wall as BARS (bony anchoring reinforcement system). This method manages the~     abdominal fascial integrity to reduce the recurrence of incisional hernia while providing an~     aesthetically superior abdominal wall contour.~   "
146822|NCT01644682|"~     Visceral leishmaniasis (VL) is a public health problem in Bangladesh, India and Nepal. To~     control the disease in these three countries a National kala-azar elimination program is~     ongoing. One of the major pillars of the elimination program is VL vector control. Currently~     there is a no public VL vector control program in Bangladesh. In India the program is~     depending on Indoor Residual Spraying with insecticides. IRS with DDT and in Nepal on~     Alpha-cypermethrin. The sand fly, vector of VL is already resistant to DDT and hurdles~     related with IRS i.e. funds, logistics and human resources make IRS unsustainable VL vector~     control method in Nepal. Thus alternative to IRS for VL vector control is highly desirable~     for the success of national kala-azar elimination program in these three countries.~      Through current research activities we will compare the effectiveness of three effective VL~     vector control methods. They are 1) Plastering of household walls with lime (a traditional~     method known in the study areas),treatment of possible sand-fly breeding places with lime and~     bleaching powder; 2) Installing durable wall lining containing deltamethrin in the main~     living room(s) of households; 3) Impregnation of existing bed-nets with slow release~     insecticide tablet containing deltamethrin.~      The study finding will be important for the national elimination program of the three~     countries through discovering the most effective VL vector control method.~   "
146823|NCT01644669|"~     The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System~     when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the~     Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when~     used as stand-alone radiation treatment in breast conserving therapy in women with early~     stage breast cancer.~   "
146824|NCT01644656|"~     The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type~     of ultrasound) in assessing the pressure of the portal vein (the major vein passing through~     the liver) and the amount of liver fibrosis in patients with chronic liver disease.~   "
146825|NCT01644643|"~     To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with~     complicated urinary tract infections and complicated intra-abdominal infections.~   "
146826|NCT01644630|"~     The aim of this study is to test whether or not the use of screw-retained implant crowns on~     customized zirconia abutments results in biological, technical and esthetic outcomes similar~     to those obtained with cemented all-ceramic crowns on customized zirconia abutments, both~     made with a computer-aided design and manufacturing procedure (CAD/CAM).~      The null-hypotheses is that marginal bone level change is equal at screw-retained and~     cemented crowns~   "
146827|NCT01644617|"~     The purpose of this study is to evaluate the dose-related effectiveness, the safety and the~     tolerability of MK-8237, compared to placebo, in the treatment of house dust mite~     (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that~     administration of MK-8237, compared to placebo, results in dose-related improvement in the~     average total nasal symptom score (TNSS) determined during environmental exposure chamber~     (EEC) challenge.~   "
146828|NCT01644604|"~     The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a~     safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3~     or more anti-hypertensive medications of different classes, of which one must be a diuretic,~     as best available antihypertensive therapy~   "
146829|NCT01644591|"~     The goal of this clinical research study is to find out if stereotactic radiosurgery (SRS)~     can control the disease in patients with more than 3 melanoma brain tumors.~      SRS is the delivery of focused, high-dose radiation given in a single session to the tumors~     with a minimal dose given to uninvolved areas of the brain.~      This is an investigational study. Up to 49 patients will take part in this study. All will be~     enrolled at MD Anderson.~   "
146830|NCT01644578|"~     This research study is being done to look at a new MRI imaging software, Siemens~     Interventional Software, to see if we can improve our ability to see and treat cancerous~     tumors.~   "
146833|NCT01644539|"~     The amount and kind of food which is ingested influences the regulation of meal size. Neural~     signals from the gastrointestinal tract travel via the vagus nerve to the brainstem and~     thalamus, which projects to the rest of the brain, in particular the hypothalamus, amygdala~     and primary sensory cortices. In neuroimaging studies in which the stomach was distended with~     a gastric balloon activation was observed in the right insula, left posterior amygdala, left~     posterior insula, left inferior frontal gyrus and anterior cingulate cortex. So far, no study~     has examined the effects of the ingestion or infusion of a food on the brain. In addition to~     neural signals, hormonal signals are important for meal termination. Hormones like insulin,~     ghrelin and cholecystokinin interact with gastric as well as sensory signals in the process~     of satiation, which ultimately leads to meal termination. The aim of this study is to~     investigate the interaction between food administration, hormone responses and brain~     responses. To this end an oral or intra-gastric load will be administered while measuring~     brain activity (functional magnetic resonance imaging) and hormone concentrations. Subjects~     will participate in one trainings session and in three functional magnetic resonance imaging~     (fMRI) sessions (35-min fMRI scan). A training session will take 40-minutes and consists of~     placing a naso-gastric tube and ingesting 500 ml of chocolate milk orally. The fMRI sessions~     will consist of three conditions: in condition one (A) 500ml of chocolate milk will be~     administrated orally. In condition two (B) and three (C) an intra-gastric load of 500 ml is~     administrated.~   "
146834|NCT01644526|"~     The ability to selectively control blood flow through an arteriovenous (AV) graft only when~     it is needed for dialysis may reduce the current repetitive complications such as thrombosis,~     venous hypertension post-dialysis bleeding, and blood steal from the extremities. The~     Hemoaccess Valve System (HVS) allows an AV graft to be turned on to blood flow when it is~     needed for dialysis then when dialysis is concluded, the device shuts off arterial blood flow~     and residual blood in the graft is flushed back into the body, using the dialysis blood~     lines. Once the graft is cleared of blood, the venous valve is then closed. Heparinized~     sterile saline reside in the graft between dialysis sessions. By having only saline in the~     graft and restoring normal blood flow to the artery and vein, it is believed that this will~     dramatically reduce the current complications associated with now having blood diverted~     through the graft 24/7.~   "
146835|NCT01644513|"~     Patients with AMD who are being or have been treated with eye injections of drugs known as~     anti-VEGF agents with either good or poor response will have DNA collected with check swabs~     for analysis.~   "
146836|NCT01644500|"~     The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe~     compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate~     glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.~   "
146837|NCT01644487|"~     The objectives of this study are to compare directly conventional balloon angioplasty alone~     versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty~     with self-expanding stent is superior to conventional balloon angioplasty - in the~     infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting~     and analyzing the cases of each patient group in a prospective multicenter randomized~     clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of~     angioplasty with self-expanding stent in the infrapopliteal arteries.~      Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in~     critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to~     conventional PTA in the aspect of vascular restenosis rate.~   "
146838|NCT01644474|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in~     comparison with ezetimibe after 24 weeks of treatment in participants with~     hypercholesterolemia.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time~          points~        -  To evaluate the effect of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
146839|NCT01644461|"~     This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous~     Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is~     being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle~     Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile~     and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in~     photographic assessment, Physician's assessment scores, Patient's assessment scores form~     enrollment to end of study.~   "
146840|NCT01644448|"~     This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of~     Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is~     being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self~     assessment score. The secondary endpoints are improvement in photographic assessment form~     randomization to end of study.~   "
146841|NCT01644435|"~     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of~     Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2~     centers in India. The primary endpoint is change in the Global Acne scarring classification~     scores from screening to end of the study. The secondary endpoints are Photographic~     Assessment, Physicians assessment score and Patients self assessment score.~   "
146842|NCT01644422|"~     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of~     Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair~     transplantation. The study is being conducted at 2 centers in India. The primary endpoints~     are Increase in Hair Follicle viability after transplant, Improvement in Caliber & Density of~     hair and Improvement in Photographic assessment from randomization to end of study. The~     secondary endpoints are Physicians and Patients self assessment score.~   "
146843|NCT01644409|"~     Long term open label study on safety and durability of the Urgent-SQ tibial implant device~     for refractory overactive bladder syndrome (OAB).~   "
146844|NCT01644396|"~     This is an open-label study designed to establish the safety and effectiveness of adalimumab~     in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.~   "
146847|NCT01644357|"~     Only a few well-designed studies have investigated the effect of pharmaceutical care on~     asthma patients and to date there are no published studies investigating this effect~     specifically on severe and refractory asthma.~      The objective of this study is evaluate the effect of pharmaceutical care on asthma control~     and quality of life (QoL) of patients with severe or refractory asthma compared with~     pharmacist dispensation only.~   "
146848|NCT01644344|"~     The standard post-operative radiographic protocol for the monitoring of fractures at HSC~     includes post-operative in hospital radiographs as well as radiographs at the two week follow~     up appointment. This is in addition to good quality intra-operative radiographs. With current~     operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal~     fixation. In fact, patients are often allowed to take weight through the fractured limb~     immediately post-operatively. In these cases, redundant post-operative radiographs likely~     represent an avoidable cost to the system financially, and an avoidable cost to the patient~     in additional time spent in hospital and unnecessary radiation exposure.~   "
146849|NCT01644331|"~     The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo~     as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute~     decompensated heart failure~      The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will~     be more effective at relieving dyspnea than fixed dose furosemide alone~   "
146850|NCT01644318|"~     The purpose of this study is to measure serum CXCL9 and CXCL11 levels in patients with~     autoimmune thyroiditis and habitual abortions~   "
146851|NCT01644305|"~     The purpose of this study is to determine the plasma levels of GDF-9 and GDF-15, and their~     association with bone and cardiovascular parameters in patients with Polycystic Ovary~     Syndrome.~   "
146852|NCT01644292|"~     The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills~     home training program for older adults in preparation for a third phase feasibility study.~   "
146853|NCT01644279|"~     The age-related loss of muscle mass and strength, also termed sarcopenia, is a commonly~     recognized consequence of aging and has been associated with frailty, functional loss,~     hospitalization, and increased mortality among older people. Sarcopenia and its consequences~     have a considerable economic impact, since it has been estimated that the healthcare cost~     attributable to sarcopenia in the US in 2000 was $ 18.5 billions. Preclinical animal models~     strongly suggest that apoptosis, a programmed cell death, might play a prominent role in the~     age-related muscle wasting. In specific aim one, the investigators will assess the extent of~     muscle apoptosis in muscle biopsies obtained from the vastus lateralis muscle of young~     control subjects (ages 20-35) and high-performance and low-performance older subjects (age~     range 70-99 years). In specific aim 2, the investigators will investigate the role of Poly~     (ADP-ribose) polymerase 1 (PARP-1) and apoptosis-inducing factor (AIF) in the induction of~     skeletal muscle apoptosis. In specific aim 3, the investigators propose to investigate the~     contribution of the muscle energy deficit, due to the age-related mitochondrial dysfunction,~     in the development of muscle wasting. Finally, in specific aim 4, the investigators propose~     to reassess after four years physical performance, muscle mass and the extent of muscle~     apoptosis, in the high-performing participants, in order to correlate eventual decline in~     physical function, muscle mass and functional status, with changes in muscle apoptosis and in~     biochemical parameters in this very old population. Physical performance will be established~     according to the summary performance score obtained in the Short Form Physical Performance~     Battery (SPPB). In addition to the SPPB the investigators will also employ hand grip strength~     and knee extensor strength tests and the investigators will quantify muscle contractile area~     using 3D magnetic resonance imaging. Disability will be assessed using a self-report~     questionnaire. These studies will enhance our understanding of the biology and~     pathophysiology underlying the geriatric syndrome of sarcopenia and provide significant and~     novel insights that will enable us to identify new potential targets for interventions aimed~     at preventing and treating sarcopenia and functional impairment in older adults.~   "
146854|NCT01644253|"~     The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination~     with rituximab, in combination with obinutuzumab, in combination with rituximab and~     idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with~     bendamustine in patients with PTCL.~   "
146855|NCT01644240|"~     This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the~     safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy~     adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy~     elderly subject population is included to evaluate the safety, tolerability, and PK of~     TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for~     all cohorts will be conducted within 21 days before the first dose.~   "
146856|NCT01644227|"~     Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip~     arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.~      Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk~     but increase the incidence of postoperative infection.~   "
146857|NCT01644214|"~     Objectives: Pelvic organ prolapse (POP) is a common condition for which pessaries are~     commonly used in conservative treatment. Despite their prevalence, there is no literature to~     guide the management of pessaries. Our objective is to determine whether patients managed~     with a pessary for POP are more satisfied with follow-up at 3 or 6 month intervals and if~     there is any difference in complications rates between the two groups.~      Hypothesis: The investigators hypothesize that there will be higher patient satisfaction in~     the group randomized to 6 month follow-up intervals and that there will be no difference in~     complication rates between the two follow-up groups.~      Method: The investigators will conduct a prospective randomized control trial comparing~     patient satisfaction and complication rates between patients with pessaries randomized to~     either 3 or 6 month follow-up intervals over 1 year.~   "
146858|NCT01644201|"~     One out of two adults in Canada is currently overweight and therefore at increased risk for a~     number of medical conditions including diabetes, high blood pressure, heart attacks and~     stroke. Obesity is less prevalent in populations consuming large amounts of dietary fibre,~     suggesting that fibre intake could play an important role in prevention and progression of~     obesity and diabetes and other conditions. Several studies have suggested that fibre has a~     positive effect on blood sugar and may help lower body weight.~      The purpose of this study is to help better understand the effect of adding fibre~     supplementation to a low calorie diet on blood sugar control and weight loss. The~     investigators hypothesize that blood sugar control will improve in participants in the fibre~     supplementation group.~      Men and women, with stable Type 2 Diabetes (e.g. no medication change in the last 3 months),~     between 18 - 75 years of age, and with a Body Mass Index (BMI) between 27 - 60 kg/m2 can~     participate in this study.~   "
146873|NCT01644006|"~     The aim of the study is to investigate the quality of prehospital emergency care in acute~     coronary syndromes, when paramedics are supported telemedically by an EMS physician.~   "
146859|NCT01644188|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as~     add-on therapy to stable maximally tolerated daily statin therapy in comparison with~     ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high~     cardiovascular (CV) risk.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time~          points~        -  To evaluate the effect of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
146860|NCT01644175|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein~     convertase subtilisin/kexin type 9 (PCSK9).~      Primary Objective of the study:~        -  To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by~          alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or~          without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of~          treatment in high cardiovascular (CV) risk participants with hypercholesterolemia~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time~          points~        -  To evaluate the effect of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
146861|NCT01644162|"~     The aim of this study is to determine whether respiratory disease exacerbations (a sudden~     worsening of symptoms) can be predicted by variables that are monitored by non-invasive~     ventilators (small machines that assist breathing) in patients requiring long term home~     ventilation.~      The investigators hypothesise that acute exacerbations of patients with respiratory disease~     and ventilatory failure will be predicted by changes in the respiratory variables monitored~     and stored by ventilators during chronic home ventilator use.~   "
146862|NCT01644149|"~     The primary objective of this study was to evaluate if administration of a seasonal flu~     vaccine using a jet injector device is comparable to traditional needle and syringe delivery~     for eliciting an immune response. A secondary objective was to compare the safety of the two~     delivery methods.~   "
146863|NCT01644136|"~     This study is being performed to investigate if the application of Arista absorbable hemostat~     (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles. Lymphoceles are~     collections of lymphatic fluid which can occur after a lymph node dissection for cancer.~     These fluid collections can become symptomatic in some patients. Arista would be applied to~     one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the~     number of postoperative lymph fluid collections seen on a computed tomography (CT) scan after~     surgery~   "
146864|NCT01644123|"~     Spasticity is a condition that results from damage to the central nervous system and causes~     painful muscle contractures that drastically affect level of independence, activities of~     daily living, and quality of life. Although there are well-known and accepted treatments for~     spasticity, spasticity is often left undertreated; the specific reasons for this observation~     are unknown. Because there is no blood test or scan that indicates the presence of~     spasticity, diagnosis is based entirely on physician impression. Therefore, the investigators~     hypothesize that one reason that spasticity is undertreated is due to the lack of a~     standardized diagnostic procedure. This study attempts to test the reliability of a~     diagnostic flowchart that seeks to increase the accuracy of physician diagnosis of~     spasticity.~   "
146865|NCT01644110|"~     The proposed study is an open-label, single-arm, Phase-Ib/II trial to assess the efficacy of~     oral drug combination ruxolitinib and pomalidomide in primary and secondary MF patients.~   "
146866|NCT01644097|"~     This randomized phase II clinical trial studies probiotic supplementation in preventing~     treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may~     help prevent diarrhea caused by treatment with chemotherapy.~   "
146867|NCT01644084|"~     It is advantageous to use 5% human albumin (HA) in patients undergoing cardiopulmonary bypass~     (CPB), because preexposure of the synthetic surfaces of the CPB circuit to albumin decreases~     coagulopathy, platelet aggregation, immune responses. However the use of albumin is limited,~     because it is expensive and can rarely cause infection.~      Hydroxyethyl starch (HES) decreases clot strength and prolong clot formation. A recently~     developed 6% HES 130/0.4 is known to have fewer effects on hemostasis. However Schramlo AA et~     al. reported that short time infusion of HES 130/0.4 after cardiac surgery produced~     impairment in fibrin formation and clot strength in thromboelastometry tracings.~      Coagulopathy is directly related to bleeding and massive postoperative bleeding increases the~     risk of reoperation. Therefore it is important to avoid administration of fluids that can~     inhibit homeostasis after CPB.~      The purpose of this study is to investigate the effect of 6% HES 130/0.4 as a component of~     priming solution on coagulation compared to 5% HA.~   "
146868|NCT01644071|"~     Aggressive behavior (AB) is a major burden to society with severe socio-economic~     consequences. Genetic studies suggest a high heritability of AB; in particular, the low~     expressing allele of the MAOA gene (MAOA-L) has been associated with increased AB. Recent~     neural aggression models have suggested a dysfunctional emotion regulation circuit including~     amygdala, orbitofrontal, and anterior cingulate cortex. Dysregulated serotonergic (5-HT)~     projections from the anterior cingulate cortex to the amygdala have been suggested to promote~     aggressive behavior. This finding is well in line with the observation that the MAOA-L allele~     leads to a reduced expression of monoamine oxidase A and thus to an overflow of 5-HT in~     serotonergic cortico-amygdalar projections. However, due to methodological and ethical~     constraints, the neural substrates of AB are difficult to assess. A possible solution is the~     use of virtual violence which permits AB against virtual characters without direct~     consequences for any real person and can be easily applied in functional imaging experiments.~     There is evidence that virtual and real aggression share common neural substrates. AB in~     violent video games inhibits rostral anterior cingulate cortex (ACC) and amygdala in line~     with the suggested neurophysiological circuits underlying real-life AB.~   "
146869|NCT01644058|"~     Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular~     overdenture assisted by 2 immediately loaded unsplinted implants.~   "
146870|NCT01644045|"~     The aim of the study is to investigate the quality of prehospital emergency care in acute~     respiratory emergencies, when paramedics are supported telemedically by an EMS physician.~   "
146874|NCT01643993|"~     Techniques to improve pregnancy and delivery rates in IVF cycles have focused not only on the~     embryos transferred, but also the conditions in the uterus at the time of transfer and~     implantation. Prior studies have shown that embryos secrete human chorionic gonadotropin~     (hCG) prior to implantation. However, in IVF cycles, the embryos have limited time to secrete~     hCG before implantation must occur because embryos are placed into the uterus rather than~     traveling there from the fallopian tubes. Recent studies have shown that the introduction of~     hCG into the uterus prior to embryo transfer may make the uterus more receptive to~     implantation. These studies involved day 3 embryos and the investigators are seeking to~     evaluate the potential benefits of hCG on implantation rates of blastocysts (day 5 or day 6~     embryos).~      The purpose of this study is to determine whether infusion of human chorionic gonadotropin~     (hCG) into the uterus immediately prior to embryo transfer results in increased implantation~     rates.~      The entire IVF cycle, fresh or frozen, will be conducted per routine. All laboratory culture~     conditions will be per routine. In fresh and frozen IVF cycles, an embryo transfer will be~     performed per routine.~      At the time of embryo transfer, participants will be randomly assigned to either the control~     group or the hCG group. Patients in the hCG group will have a mock embryo transfer with 20µL~     of transfer media including 500IU of hCG. Patients in the control group will have a mock~     embryo transfer with 20µL of transfer media.~      All post-transfer care and pregnancy monitoring will be identical and per routine protocol.~   "
146875|NCT01643980|"~     The preterm birth is considered as a main problem in the modern obstetrics, being the~     responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the~     significant medical advances, the rate of prematurity has not declined over the past 40 years~     and even continues to rise in the developed countries. In order to decrease the prematurity~     is necessary that two premises: to identify the pregnant women at risk of preterm birth, and~     dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm~     delivery. The investigators propose a clinical trial with the objective to identify effective~     strategies to reduce the premature birth (34 weeks and earlier) rate in the population of~     pregnant women at risk for premature birth, which will be identified by ultrasound during the~     second trimester of their pregnancy.~      The investigators intend to compare two accepted strategies: administration of progesterone~     (vaginally) or the placement of vaginal pessaries. These 2 strategies are affordable, easy to~     apply, and they present very few maternal-fetal secondary effects.~   "
146876|NCT01643967|"~     This is a open, phase III, multicenter, prospective, comparative, controlled, randomized~     clinical trial to evaluate the efficacy and safety of the use of ozone released by Philozon~     Medplus device versus conventional therapy in treating patients with diabetic foot.~   "
146877|NCT01643954|"~     This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.~   "
146878|NCT01643941|"~     This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of~     a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose~     level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). The main goal of the study is to~     determine how safe and well tolerated the vaccine is as well as to describe the immune~     response elicited by the vaccine in healthy adults aged 65 to <86 years. In addition, the~     study aims to assess the effect of the Staphylococcus aureus vaccine on the presence of the~     Staphylococcus aureus within the nose, throat and perineal skin of healthy adults aged 65 to~     <86 years.~   "
146879|NCT01643928|"~     This extension study will evaluate the safety (including immunogenicity) of treatment with~     rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from~     rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment~     access to subjects with active rheumatoid arthritis who have participated for at least 16~     weeks in other studies in the rituximab Pfizer program.~   "
146880|NCT01643915|"~     The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric~     patients during dental treatment improves when a cartoon film is viewed or a videogame is~     played as methods of distraction.~   "
146881|NCT01643902|"~     The primary objective of this study is to evaluate the safety of intravenous tissue~     plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and~     presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting~     standard criteria for treatment with IV tPA for acute stroke.~      The hypothesis is that patients that wake up with stroke symptoms may have developed the~     stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the~     ED within that time, therefore IV tPA should be safe and effective in this population.~   "
146882|NCT01643889|"~     The purpose of this study is to assess the effects of single and multiple doses of~     domperidone on the QTc interval duration in healthy adult volunteers at domperidone doses of~     10 mg four times a day (q.i.d.) and 20 mg q.i.d.~   "
146883|NCT01643876|"~     Palatal brushing has several advantages including removal of debris and stimulation of blood~     flow and saliva, which may help to prevent or treat oral diseases, such as denture-related~     stomatitis in complete denture wearers.~      However, there is no previous clinical trial testing this effect. Therefore, the~     investigators goal is to evaluate whether palatal brushing may change the severity of denture~     stomatitis and counts of microbes on denture and palatal mucosa.~      After an initial exam and data collection, participants will receive instructions about~     palatal brushing and they will be assessed after 1 and 3 months. Collection of data will~     include patient-reported information, intraoral photographs and swabbing (for counting~     microbes).~      Tested Hypotheses:~        -  There is no difference in the extent of palatal inflammation in edentulous patients with~          denture stomatitis before and after 3 months of palatal brushing.~        -  There is no difference in the number of colony forming unit (CFU) of Candida isolated~          from palate and denture of patients affected by denture stomatitis before and after 3~          months of palatal brushing.~   "
146884|NCT01643863|"~     This multi-center observational study will evaluate the use of RoActemra/Actemra~     (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible patients~     initiated on RoActemra/Actemra treatment according to the licensed label will be followed for~     6 months.~   "
147326|NCT01638052|"~     The investigators goal is to determine the efficacy and duration of analgesia with the~     addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of~     the great auricular nerve in children undergoing tympanomastoid surgery.~   "
146885|NCT01643850|"~     This study, designed as a proof of concept study of MCS110 in pigmented villonodular~     synovitis, will assess the clinical response to MCS110 treatment in Pigmented Villonodular~     Synovitis (PVNS) and Giant cell tumor of the tendon sheath (GCTTS) patients after multiple~     intravenous doses of MCS110 using magnetic resonance imaging to assess tumor volume, and to~     evaluate pharmacokinetics/pharmacodynamics, safety and tolerability in this population.~   "
146886|NCT01643837|"~     There are many current medical treatments for mastalgia, but few have been proven effective.~     Our objective is to evaluate the effectiveness of osteopathic manipulative treatment as~     compared to a light touch protocol and standard management in the treatment of women with~     cyclical and non-cyclical mastalgia. We will compare duration of the pain, severity of the~     pain and the effect of the pain on quality of life.~   "
146887|NCT01643824|"~     This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy~     (PBT) for HCC patients in hepatitis B endemic area.~   "
146888|NCT01643811|"~     The purpose of this study is to determine whether the extent of gastrectomy and anastomosis~     type affect chronic metabolic disease such as diabetes and hypertension in early gastric~     cancer patients.~   "
146889|NCT01643798|"~     Studies have shown that transcranial magnetic stimulation (TMS), a non-invasive form of brain~     stimulation, can reduce pain in the laboratory and in the clinic. The purpose of this study~     is to investigate how TMS relieves pain and affects pain circuitry in the brain. One of the~     primary study hypotheses is that opioid blockade will significantly reduce the pain relief~     produced by left prefrontal cortex TMS.~   "
146890|NCT01643785|"~     Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a~     reduction in mucus viscosity. As part of the search for more effective forms of therapy~     against H. pylori when it colonizes not only the surface of the surface mucosal cells but~     also the surface mucous gel layer covering the mucosal surface of the stomach. The~     investigators decided to investigate whether or not endonase might have additive effect of~     pronase on the efficacy of the second-line eradication therapy against Helicobacter pylori.~   "
146891|NCT01643772|"~     A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a~     multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with~     pain.It will be a single center, open label, randomized, oral administration study.~   "
146892|NCT01643759|"~     This is a single center, open label, randomized, parallel group single dose pharmacokinetic~     (PK) study.~   "
146893|NCT01643746|"~     The primary goal of this trial is to compare prospectively stent opening of Supera (IDEV~     Technologies) versus a reference stent (LifeStent, Bard Medical) using C-arm CT. A secondary~     goal is to correlate stent opening with stent patency as documented by Doppler ultrasound at~     one year post implantation.~   "
146894|NCT01643733|"~     Hypothesis: The primary objective of this study is to assess whether using a flow measurement~     device, in this case the Transonics flow device, as an end-point to interventional treatment~     of diseased dialysis fistulae can help increase immediate treatment success in terms of~     quality of dialysis immediately following the treatment and increasing time to~     reintervention.~   "
146895|NCT01643720|"~     In the proposed study, the investigators would like to investigate the emotion regulation~     (ER) strategies children with Autism Spectrum Disorders (ASD) demonstrate, and the influence~     parents have on their children's ER. More specifically, the investigators would like to~     examine what are the ER mechanisms that parents use, what mechanisms of self regulation~     children with autism internalize, and how parents support and improve the ER capabilities of~     their child with ASD. These will be studied in a behavioral level, using micro-analysis of~     parent-child interaction, and in a physiological level, using indexes of stress control and~     affiliation. In addition, in order for parental ER support to be effective, it is important~     to consider more innate neuro-developmental difficulties children with ASD demonstrate that~     strongly affect their ability to regulate themselves. These include sensory regulation~     difficulties, temperament, attention disorders and poor executive functioning.~      Hypotheses:~        1. ER strategies used by children with ASD will be more poorly developed and less~          effective, compared to those of children in the control groups.~        2. Difficult temperament and sensory regulation difficulties will hamper ER in children~          with ASD.~        3. ER strategies of parents of children with ASD will be more poorly developed and less~          effective than those of parents in the control groups.~        4. Good parental self-ER and parental attunement to the child will be predictive of~          improved ER in children with ASD, and in parent-child synchrony, both in the behavioral~          and in the physiological levels.~   "
146896|NCT01643707|"~     Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)~      The study is expected to provide evidence to support claim(s) that:~        -  Education and process improvement initiatives can improve the diagnosis of and~          appropriate therapy application for sinus node dysfunction (SND)~        -  The quality improvement methods studied have general applicability and can be used by~          all centers~        -  Appropriate treatment minimizes caregiver burden~        -  Appropriate treatment improves quality of life (QOL) and functional status compared to~          pre-implant~   "
146897|NCT01643694|"~     To determine if physicians who complete brief tasks intended to promote meaning in work and~     job satisfaction, foster teamwork and social support at work, nuture personal relationships~     and work-life balance, recognize and build on personal strengths, encourage effective problem~     solving, and promote positive emotions have improved resilience, meaning in work, and~     engagement at work.~   "
146898|NCT01643681|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     lumbar intervertebral disc degeneration.~   "
146924|NCT01643343|"~     The purpose of this research is to study joint attention. Joint attention plays a critical~     role in social and language development in children with and without autism. Joint attention~     is the shared attention between a child and another person. This study seeks to set a~     standard benchmark of frequency scores for joint attention. Finding a rate of engaging in~     joint attention behavior would offer a benchmark for all researchers and practitioners~     working with learners with and without autism.~   "
146925|NCT01643330|"~     The purpose of this trial is to assess whether MYDICAR can reduce the frequency and/or delay~     heart failure related hospitalizations in persons with advanced heart failure when added to~     their maximal and optimized therapy.~   "
146899|NCT01643668|"~     This research is a phase II clinical trial. Phase II clinical trials test the effectiveness~     of an investigational intervention to learn whether it works in treating a specific cancer.~     Investigational means that the study intervention is still being studied and that research~     doctors are trying to find out more about it. It also means that the FDA has not yet approved~     this study intervention for your type of cancer.~      All participants on this study are treated in an identical manner. The investigators are~     doing this study because there continues to be a significant risk of relapse of disease after~     reduced intensity transplantation. In studies which have compared transplants using~     high-doses of chemotherapy and/or radiation versus reduced intensity transplants, patients~     undergoing reduced intensity transplants appear to have higher rates of relapse, but lower~     rates of toxicity and complication. This study attempts to utilize clofarabine, a newer~     chemotherapy agent shown to be quite active in AML, ALL, and MDS, to increase the anti-tumor~     effects of the conditioning regimen without accumulating unacceptable toxicity.~      The reduced intensity allogeneic stem cell transplantation procedure involves giving you~     chemotherapy in relatively less intense doses to suppress your immune system. This is~     followed by an infusion of healthy blood stem cells from a matched related donor or a matched~     unrelated volunteer donor. It is hoped that these donor cells can eventually then attack any~     cancer cells which remain.~      In this research study, the investigators are looking to see how well this new combination of~     busulfan and clofarabine works in reduced intensity allogeneic stem cell transplantation. By~     works the investigators mean to analyze safety, ability of donor cells to engraft (take~     hold), as well as measures of complications including toxicity, infections, graft-vs-host~     disease (GVHD), and relapse.~   "
146900|NCT01643655|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     avascular necrosis of the femoral head.~   "
146901|NCT01643642|"~     This study compares both clinical effectiveness and cost-effectiveness of a brief,~     intensified therapy and diagnostic method for patients with mood and/or anxiety disorders~     with Treatment As Usual (TAU) at five outpatient Mental Healthcare Centers in the~     Netherlands.~   "
146902|NCT01643629|"~     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of~     Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being~     conducted at 2 centers in India. The primary endpoints are Improvement in Caliber & Density~     of hair and Improvement in Photographic assessment from randomization to end of study. The~     secondary endpoints are Physicians and Patients self assessment score.~   "
146903|NCT01643616|"~     For distal sciatic nerve block this prospective, randomised comparison with ultrasound guided~     distal subepineural block tested the hypothesis, that intraepineural injection of local~     anesthetic using nerve stimulation technique is common and associated with high success rate.~   "
146904|NCT01643603|"~     This study uses a drug called dasatinib to produce an anti-cancer effect called large~     granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as~     natural killer cells that remove cancer cells. Researchers think that dasatinib may cause~     large granular lymphocyte expansion to happen in patients who have received a blood stem cell~     transplant (SCT) between 3 to 15 months after the SCT. In this research study, researchers~     want to find how well dasatinib can be tolerated, the best dose to take of dasatinib and how~     to estimate how often large granular lymphocytic cellular expansion happens at the best dose~     of dasatinib.~   "
146905|NCT01643590|"~     This is a randomized, double-blind, placebo controlled Phase II study is designed to assess~     the safety and efficacy of using JVS-100 to treat heart failure.~   "
146906|NCT01643577|"~     Gastroparesis is a disorder characterized by delayed gastric emptying leading to symptoms of~     nausea, vomiting, bloating, and abdominal pain. A common cause is diabetes but even more~     often it occurs in otherwise healthy individuals. The symptoms of gastroparesis can~     significantly alter a patient's quality of life. Current therapies are limited. In this~     study, the investigators seek to determine if twice weekly acupuncture treatments can improve~     symptoms of gastroparesis.~   "
146907|NCT01643564|"~     Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft~     dysfunction.~   "
146908|NCT01643551|"~     An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD~     recipients before and following VAD implantation.~   "
146909|NCT01643538|"~     The goal of this randomized and controlled trial is to test whether a financial incentive of~     a donation to achieve a social goal is more effective to motivate and sustain a daily walking~     habit than the same dollar value given to an older adult. The investigators will achieve this~     using a novel computer platform utilizing a digital pedometer-internet interface.~   "
146910|NCT01643525|"~     That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity to~     hyper acute ischemic stroke than does CT.~   "
146911|NCT01643512|"~     Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the United~     States. The cause of NAFLD is poorly defined but is thought to involve complex interactions~     of genetic and environmental factors. NAFLD is often associated with the traits of the~     metabolic syndrome including diabetes, high cholesterol or elevated blood pressure.~     Currently, there are no accurate noninvasive means of evaluating NAFLD and its more serious~     form which includes inflammation that may lead to severe scarring in the liver. The goal of~     this study is to evaluate shared genetic factors that underlie NAFLD and features of the~     metabolic syndrome as determined by blood work and radiographic studies in a cohort of twins~     and first degree relatives.~   "
146912|NCT01643499|"~     This study is being done to determine the dose of a chemotherapy drug (irinotecan [irinotecan~     hydrochloride]) that can be tolerated as part of a combination of drugs. There is a~     combination of chemotherapy drugs often used to treat gastrointestinal cancer, which consists~     of 5-FU (fluorouracil), leucovorin (leucovorin calcium), irinotecan and oxaliplatin and is~     known as FOLFIRINOX. FOLFIRINOX is a current drug therapy combination (or regimen) used for~     people with advanced pancreatic cancer, although this combination is not Food and Drug~     Administration (FDA) approved for this indication. FOLFIRINOX was recently shown in a~     separate clinical trial to increase survival compared to another commonly used drug in~     pancreatic cancer called gemcitabine. FOLFIRINOX is also a reasonable regimen for those with~     other advanced cancers of the gastrointestinal tract, including colon cancer, rectal cancer,~     esophagus cancer, stomach cancer, gall bladder cancer, bile duct cancer, ampullary cancer,~     and cancers with an unknown primary location. The best dose of irinotecan to use in~     FOLFIRINOX is not known. This study will analyze one gene (uridine 5'-diphospho [UDP]~     glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] gene) of subjects for the presence~     of an alteration in that gene, which may affect how the body handles irinotecan. Genes help~     determine some of the investigators individual characteristics, such as eye color, height and~     skin tone. Genes may also determine why people get certain diseases and how medicines may~     affect them. The result of the genetic analysis will divide subjects into one of three~     groups: A, B, or C. Group A (approximately 45% of subjects) will receive the standard dose of~     irinotecan. Group B (approximately 45% of subjects) will receive a lower dose of irinotecan.~     Group C (approximately 10% of subjects) will receive an even lower dose of irinotecan~   "
146941|NCT01643122|"~     Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the~     Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable,~     valid and able to detect changes over time in approximately 250 patients with mild, moderate~     or severe endometriosis confirmed by laparoscopy.~   "
146913|NCT01643486|"~     Hypothesis: The use of a program that assists with selection of the appropriate number of~     phosphate binders for a meal based on patient specific factors will result in improved serum~     phosphate control, a reduction in overall number of phosphate binders used and enhanced~     patient satisfaction.~      Primary Aim: To determine if teaching patients to use a 'phosphate counting' program~     installed on an iTouch that selects the appropriate amount of phosphate binder to be taken~     with each meal is associated with better phosphate control than usual care.~      Research Plan: There will be 3 phases to the study. Phase 1: Recruitment of 60 peritoneal~     dialysis (PD) patients. The information generated from this phase will be used to develop the~     iTouch program for phosphate counting and matching binder number. Phase 2: iTouch program~     once developed will be pilot tested on a convenience sample of 10 PD patients and modified if~     required. Phase 3: Randomized controlled trial of 92 PD patients to determine if using the~     iTouch phosphate counting program reduces serum phosphate compared to controls. Success would~     be based on seeing a statistically significant difference in serum phosphate as expected from~     our sample size calculation~   "
146914|NCT01643473|"~     The purpose of this study is to to culturally tailor a technology-based individualized~     adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are~     non-adherent to their medications, and determine its acceptability.~   "
146915|NCT01643460|"~     The purpose of this study is to track outcomes and complications of patients at IUMC referred~     by physicians for EUS-guided pancreatic cyst ablation. This information is essential in order~     to disseminate future published information to physicians about this technique. A database~     will be created to track these patients undergoing an already scheduled/planned procedure.~     Phone calls at selected intervals will be made following the procedure to track any~     complications that occur~   "
146916|NCT01643447|"~     The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it~     can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that~     Ulinastatin can improve survival in HCC patients or not.~   "
146917|NCT01643434|"~     Resistant hypertension (ReHy) is an emerging clinical and public health problem which tends~     to increase because populations are living longer and there is a growing global epidemic of~     obesity, diabetes and sleep apnea. It is also tempting to speculate that the excessive~     dietary salt ingestion reported in many countries can contribute substantially to the risk of~     ReHy development. ReHy is defined as persistent high blood pressure (above the target goal)~     in spite of the use of at least 3 antihypertensive agents of different classes, one of them~     must being diuretics.~      Data regarding the exact prevalence of ReHy are very limited. In addition, little data is~     available about 3-drug combinations but a simplified treatment algorithm has demonstrated~     that a combination of a diuretic plus an angiotensin-converting enzyme inhibitors (ACEi) or~     an angiotensin-receptor blocker (ARB) plus diuretic, adding a calcium channel blocker when~     necessary, controlled 64% of hypertensive patients and, in addition, was even more efficient~     than the current guideline-based management. By contrast, the fourth drug to be added-on the~     triple regimen is still controversial and guided by empirical choices or personal~     preferences. Recent studies suggest the emerging role of spironolactone as the first-line~     fourth drug for treating resistant hypertension. Conversely, because of the~     pathophysiological rationale, others have proposed the use of β-blockers or even centrally~     acting agents for managing the sympathetic hyperactivity. The present concerns about the~     limited blood pressure reducing effect of β-blockers, especially in elderly people, the~     potent effect of centrally acting agents and our personal experience are pointing to~     clonidine as the fourth drug to be added-on to a multidrug combination for reaching optimal~     blood pressure in patients with ReHy. Nevertheless, no studies have been performed comparing,~     head-to-head, which one is the best fourth drug (spironolactone or clonidine) to be added-on~     to a common used multidrug combination in order to treat this condition.~      Therefore, the principal objectives of the ReHOT Trial are to assess prospectively: (1) the~     prevalence of ReHy in a cohort of outpatients with stage II hypertension; (2) the effect of~     spironolactone on blood pressure, in comparison to clonidine, when added to a multidrug~     combination consisting of chlorthalidone plus ACEi (or ARB) plus amlodipine, all of 3~     up-titrated to the highest dose; (3) the role of measuring sympathetic nervous system~     activity and renin-angiotensin-aldosterone activity on predicting the response of blood~     pressure to spironolactone and clonidine.~   "
146918|NCT01643421|"~     The purpose of this study is to determine the effects of a deep inspiration combined to~     expiratory positive airway pressure protocol on respiratory function, quality of life,~     exercise tolerance and heart rate variability in adults with severe asthma.~   "
146919|NCT01643408|"~     This study will utilize Erwinaze via intravenous administration in patients between the ages~     of 1 and 30 who have experienced an allergy to their frontline therapy. The study will~     determine the proportion of patients with 2 day nadir serum asparaginase activity levels that~     are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.~   "
146920|NCT01643395|"~     The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering~     from acute non osteoporotic vertebral compression fracture.~      Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to~     prevent further collapse.~      Our study will compare vertebroplasty versus conservative therapy (brace).~   "
146921|NCT01643382|"~     Based on multiple prior studies, kidney transplant recipients with diabetes are at higher~     risk for poor initial graft function after transplant. Our study is designed to determine if~     tight blood sugar control around the time of kidney transplant will improve short term graft~     function.~   "
146922|NCT01643369|"~     Important health benefits of meditation may be conferred as much by what people actually do~     and say in their daily lives as by how they self-perceive the effect of training on their~     behavior and emotions. To test this hypothesis, and to explore whether specific elements of~     meditation (e.g. compassion vs. mindfulness) have different effects on real-world social~     behavior, the current project proposes to use the Electronically Activated Recorder (EAR) in~     a randomized, longitudinal design to objectively measure whether meditation does indeed make~     people behave in happier, kinder and more prosocial ways in their daily lives. This design~     will permit an exploratory analysis of how such behavioral transformations might relate to~     subjective reports of meditative effects. To accomplish these objectives, 108 medically~     healthy adults will be randomized to 8 weeks training in compassion meditation (n=36),~     Mindfulness Attention Training (MAT) (n = 36) or to an active control condition consisting of~     a health education discussion group (n=36). Prior to randomization and again upon completion~     of these interventions, all subjects will participate in an EAR protocol to evaluate the~     effect of meditation training on their real-world prosocial and affiliative behavior. Based~     on prior research and direct pilot data from 25 participants, prosocial and affiliative~     behavior will be assessed as the amount of (1) shown empathy and affection, (2) laughing vs.~     sighing, (3) arguing and complaining, (4) time spent interacting with others vs. alone, (5)~     meaningful conversations, (6) socially inclusive (i.e. use of we/us) vs. self-focused~     (i.e. use of I/me) first person language. Following the first EAR assessment, subjects~     will commence 8 weeks of compassion meditation training, MAT, or attendance in the health~     discussion group. Following these interventions subjects will participate in EAR monitoring~     identical to the initial assessment. To assess whether changes in daily behavior are~     sustained over a longer period, all subjects will undergo a final EAR assessment 6 months~     following completion of the study interventions. Self-report measures of social integration~     and support and behavioral/lifestyle variables that might be associated with EAR outcomes~     will be evaluated prior to each EAR assessment and treated as covariates.~   "
146923|NCT01643356|"~     The study will use a comprehensive behavioral intervention adapted for pregnant women to~     change dietary intake, eating behavior and physical activity. The central hypothesis of this~     study is that the intervention will reduce excess gestational weight gain and achieve~     clinical and metabolic benefits in obese and overweight pregnant women and their infants over~     the first year of life.~   "
146926|NCT01643317|"~     Screening studies for Abdominal Aortic Aneurysms (AAA) in 65 to 79 years aged men, have shown~     a significant reduction in AAA related mortality. In addition, the cost-effectiveness of~     screening for AAA in men in the Netherlands has been demonstrated by using a Markov model.~     Screening might be even more (cost-) effective if targeted on high risk groups, such as~     patients with a particular cardiovascular disease with a known increased risk of having an~     AAA.~      Project SCAN (Screening CardioVascular patients for Aortic aNeurysms) is a project focused on~     targeted AAA screening to proactively diagnose patients at high risk of having an aneurysm~     that eventually may rupture. This pilot project aims to study the value of a screening~     protocol in daily practice to detect AAA's in high risk patients.~   "
146927|NCT01643304|"~     This field based, questionnaire study will document observational data on womens perception~     of menstrual bleeding in a cross-section of women in Sweden. Each subject will complete the~     questionnaire at one occasion.~   "
146928|NCT01643291|"~     Hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment~     and therapy. When LP is difficult, the patient may endure multiple attempts, prolonged~     anesthesia time, and with failure of LP may require fluoroscopy-guidance with associated~     radiation exposure. This investigation will evaluate lumbar punctures performed in the~     intraoperative setting by oncologists with ultrasound guidance performed by the~     anesthesiologist in the leukemic pediatric population. The investigators hypothesis is that~     anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of~     attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.~   "
146929|NCT01643278|"~     This phase I trial studies the side effects and best dose of dasatinib when given together~     with ipilimumab in treating patients with gastrointestinal stromal tumors or other sarcomas~     that cannot be removed by surgery or have spread to other places in the body. Dasatinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways by~     targeting certain cells. Giving dasatinib together with ipilimumab may be a better treatment~     for patients with gastrointestinal stromal tumors or other sarcomas.~   "
146930|NCT01643265|"~     The purpose of this study will allow us to examine how quickly and to what extent plasma~     amino acids levels rise after ingesting a single dose of either whey or albumin protein. The~     investigators anticipate that the amino acids from albumin concentrate protein will rise as~     quickly and to the same extent as amino acids from whey protein. These findings will help us~     to understand the biological availability of these proteins and efficacy of the supplement so~     that consumers may be presented with nutritional options.~   "
146931|NCT01643252|"~     The objectives of this study are to evaluate the safety and efficacy of corneal collagen~     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as~     compared to placebo in impeding the progression of, and/or reducing, maximum corneal~     curvature.~   "
146932|NCT01643239|"~     The purpose of this study will employ clinical assessment tools to examine the effects of~     modified constraint-induced therapy (mCIT) on the more affected upper extremity of children~     with cerebral palsy.~   "
146933|NCT01643226|"~     The objectives of this study are to evaluate the safety and efficacy of corneal collagen~     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as~     compared to placebo in impeding the progression of, and/or reducing, maximum corneal~     curvature.~   "
146934|NCT01643213|"~     The purpose of this study is to evaluate patient preference of the Boston Scientific~     Corporation (BSC) commercially approved spinal cord stimulation (SCS) systems with the~     Observational Mechanical Gateway (OMG) in patients who failed non-BSC SCS trial therapy.~   "
146935|NCT01643200|"~     Evaluate the safety and feasibility of the Medtronic Zotarolimus stent to improve erectile~     function in males with sub-optimal response to PDE5i therapy due to atherosclerotic lesions~     of the internal iliac and/or internal pudendal arteries.~   "
146936|NCT01643187|"~     The purpose of this study is to measure the impact of a fortified food on the nutritional and~     micronutrient status of malnourished children, compared with milk. The changes to be~     evaluated include the indicators weight for height, height for age, weight for age, mid-arm~     circumferance for age; and levels of hemoglobin, serum zinc, serum ferritin, serum folic~     acid, erythrocyte folic acid, serum vitamin B12, and urinary iodine.~   "
146937|NCT01643174|"~     Within defined groups of primary malignant and benign bone and soft tissue spine tumors, what~     variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with overall~     survival?~   "
146938|NCT01643161|"~     Functional (psychogenic or somatoform) symptoms are commonly observed in neurology clinics.~     There is no known empirically validated treatment approach to functional symptoms. Cognitive~     Behavioral Therapy (CBT) can be effective, but there are major obstacles to its provision.~     The investigators will test the hypothesis that adding a CBT-based guided self-help (GSH) as~     compared to treatment as usual (TAU) improves patient outcomes.~   "
146939|NCT01643148|"~     Objective:~      Evaluate body mass index (BMI), leptin, Leptin/adiponectin (L/A) ratio and cancer antigen~     (CA) 15-3 together as reliable biomarkers for breast cancer.~      Patients:~      Consecutive patients aged between 40 - 60 years, with breast disease and informed consent.~      Interventions:~      Patients' Anthropometric and laboratorial characteristics classified by BMI in the group of~     cancer and patients with benign breast disease as well as biochemical tests of leptin,~     adiponectin,CA 15-3, hemoglobin, glucose low-density lipoprotein cholesterol (LDLC),~     high-density lipoprotein cholesterol (HDLC) levels were obtained as well as a blood sample to~     analyze CA 15-3 levels with a electrochemiluminescence immunoassay.~      Hypothesis:~      Using together leptin, L/A ratio, CA 15-3 and BMI could offer a reliable approach to detect~     high risk women to develop breast cancer.~   "
146940|NCT01643135|"~     Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations~     such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few~     studies in laminectomy had conflicting results and varying in doses. The objective is to~     compare perioperative bleeding in major laminectomy between patients receive doubles doses of~     tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).~   "
146952|NCT01642979|"~     Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is~     designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in~     patients with classic paroxysmal nocturnal hemoglobinuria.~   "
146942|NCT01643109|"~     CIMT has shown great promise in helping children and adults regain lost function in a~     disabled limb by forcing its use through an intensive motor training program and constraining~     the unaffected arm with a cast. However, relatively little is known about the underlying~     mechanisms of CIMT in hemiplegic CP. This project will use an integrated translation model to~     explore neuroimaging predictors of a positive clinical response to CIMT.~   "
146943|NCT01643096|"~     The purpose of this study is to determine the effect of Zataria multiflora Boiss and Sumac on~     the thermic effect of food, activity of sympathetic - parasympathetic system: comparison~     between warm and cold temperament people.~   "
146944|NCT01643083|"~     Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people~     in the community. However, results of current pharmacological treatment on functional~     dyspepsia are unsatisfactory. Rifaximin is a minimally absorbed antibiotic that has been used~     in treatment of non-constipated irritable bowel syndrome (IBS). In particular, bloating and~     abdominal pain was improved by rifaximin treatment in this group of IBS patients. Whilst~     there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators~     test whether rifaximin is also effective in curing post-prandial distress symptoms related to~     dyspepsia.~   "
146945|NCT01643070|"~     To investigate the feasibility of preoperative chemoradiation with oxaliplatin plus~     capecitabine, with or without prior induction chemotherapy in patients with locally advanced~     or marginally resectable rectal cancer with resectable synchronous liver metastases.~   "
146946|NCT01643057|"~     The purpose of this study is to explore physiological interventions and biomarkers for Apnea~     of Prematurity in newborn infants.~   "
146947|NCT01643044|"~     The purpose of this study is to lay the ground work for a fully powered clinical trial of a~     computer-delivered screener and intervention for alcohol use during pregnancy. The pilot~     study will include:~        1. Evaluation of the usefulness of handheld devices and anonymous screening for self report~          of at-risk alcohol use among pregnant women.~        2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the~          detection of at-risk drinking in pregnant women.~        3. Evaluation of the efficacy of a computer-delivered brief intervention and use of~          tailored handouts to supplement the computer-based brief intervention focusing on~          alcohol use during pregnancy.~   "
146948|NCT01643031|"~     In recent years numerous studies have shown that the response of patients to the~     anti-platelet drug clopidogrel is widely variable. Furthermore, patients who do not respond~     well to the drug (resistant) have been shown to be at increased risk to develop cardiac~     events, including myocardial infarction and mortality. It thus seems reasonable to test the~     efficacy of the drug (by platelet function tests) and modify treatment accordingly. However,~     a large study that examined a strategy of routine testing of clopidogrel response in~     thousands of patients (GRAVITAS study) did not show any clinical benefit. This study was~     limited, however, by a very low event rate (2.3%), and by the strategy employed to treat~     patients with low response (increasing the clopidogrel dose), which is currently known to be~     ineffective in many patients with low response. To overcome these limitations the~     investigators plan to examine a high risk population - patients with diabetes planned to~     undergo coronary angiography - and to treat clopidogrel low responders by switching their~     treatment to the potent anti-platelet drug ticagrelor, which has been shown to overcome~     clopidogrel low response.~      The investigators hypothesize that patients with diabetes and low response to clopidogrel~     will benefit clinically from switching therapy to ticagrelor. The main endpoint of the study~     will be the risk of myocardial enzyme elevation following percutaneous coronary intervention~     (PCI); a marker which has been strongly associated with poor clinical outcome.~      The aim of the study is, therefore, to assess whether a strategy of monitoring platelet~     function during clopidogrel treatment in patients with diabetes undergoing PCI, and modifying~     treatment to ticagrelor in patients with low response, will be associated with reduced risk~     of myocardial enzyme release.~      The investigators plan to enroll patients with treated diabetes, planned to undergo coronary~     angiography. Patients with acute or recent myocardial infarction will be excluded. They will~     be tested for response to clopidogrel by the VerifyNow P2Y12 assay (either on chronic~     clopidogrel treatment or 12-24 hours after receiving 300 mg clopidogrel). Patients with low~     response to clopidogrel (≥ 208 PRU) will be randomized to either continued treatment with~     clopidogrel (75 mg/day), or switching of treatment to ticagrelor (90 mg twice a day) for 30~     days (followed by continued clopidogrel therapy). The primary endpoint will be the rate of~     troponin of CK-MB (cardiac enzymes) measured 20-24 hours after the PCI. Secondary endpoints~     will be the occurrence of adverse clinical endpoints - myocardial infarction, need for urgent~     revascularization or mortality at 30 days. The investigators aim to enroll 100 patients in~     each study group (ticagrelor vs. continued clopidogrel). Assuming a clopidogrel low response~     rate of 40% among patients with diabetes, about 500 patients would have to be screened to~     identify 200 patients with low response.~   "
146949|NCT01643018|"~     Echinococcosis in humans is a parasitic tapeworm infection, caused by a larval stage (the~     metacestode) of Echinococcus species. The infection can be asymptomatic or severe, causing~     extensive organ damage and even death of the patient.~      Echinococcosis is one of the most neglected parasitic diseases and the lack of the~     prospective randomised studies supports this idea. Development of new drugs and other~     treatment modalities receives very little attention, if any. In most developed countries,~     Cystic Echinococcosis (CE) is an imported disease of very low incidence and prevalence and is~     found almost exclusively in migrants from endemic regions. In endemic regions, predominantly~     settings with limited resources, patient numbers are high.~      The aim of the hydatid cyst treatment is the death of the parasite and consequently the cure~     of the disease. It has to be done with a minimal risk and maximum comfort for the patient,~     and always paying attention to avoid complications, secondary hydatidosis, and relapses.~      There are several treatment modalities. Of them the most preferred surgical method is~     traditional cyst management through a laparotomy incision. Same can be done with laparoscopy.~     In the past 15 years significant advances in laparoscopic surgical skills and techniques~     combined with explosive advances in laparoscopic technology have encouraged the application~     of laparoscopy to the evaluation and treatment of solid organs including the liver. There are~     many studies about the laparoscopic treatment of liver hydatid cyst published in the~     literature and the feasibility of this procedure has been demonstrated by them. While the~     majority of them are case reports or case series, there are some relatively large series~     comparing open versus laparoscopic surgery published in the last decade, which all are not~     randomized trial.~   "
146950|NCT01643005|"~     This study seeks to develop, implement, and assess an innovative 15-session couple-based~     intervention to be delivered in a group format to young parents that aims to strengthen~     relationships and reduce HIV risk. The ultimate goal of our intervention is to reduce HIV/STD~     risk (concurrency, number of partners, unprotected sex), strengthen relationships, and~     improve parenting among young parenting heterosexual couples.~   "
146951|NCT01642992|"~     The COBIS II registry is a multi-center, real-world registry of drug-eluting stenting in~     coronary bifurcation lesions in South Korea. From 18 major coronary intervention centers in~     Korea, a total of 2,873 patients were enrolled in this database between January 2003 and~     December 2009.~      The aim of the study was to investigate long-term clinical results and predictors of adverse~     outcomes after percutaneous coronary intervention with drug-eluting stents for coronary~     bifurcation lesions in South Korea.~   "
146953|NCT01642966|"~     This is a prospective, randomized, single-blind, investigator-initiated, crossover study.~     Patients with Acute Coronary Syndrome (ACS) subjected to percutaneous coronary intervention~     (PCI), are randomized after informed consent, in a 1:1 ratio to either ticagrelor 90mg x2 or~     prasugrel 10mg x1 for 15 days. At Day 15± 2 days, coronary diastolic blood flow velocity in~     left anterior descending artery (LAD) is evaluated at baseline (bCBFV) and under 2 min~     adenosine infusions (maximal diastolic CBFV- maxCBFV) at gradually increasing doses of~     50μg/kg/min, 80μg/kg/min, 110μg/kg/min and 140μg/kg/min with at least 5 min recovery~     intervals between infusions. A crossover directly to the alternate treatment is performed~     followed by the same evaluation at Day 30±2 days .~   "
146954|NCT01642953|"~     Study preparation~        -  To progress this prospective study, the investigators analyzed the retrospective data of~          426 patients who had been managed with conventional critical pathway after gastric~          cancer surgery during last 1 year.~        -  Through this retrospective analysis, we decided the inclusion criteria which showed~          significantly the lower complication rate and shorter hospital stay.~      Method for Prospective study~        -  Patients who enroll in this prospective study are administered and are supplied a liquid~          diet one day before surgery without bowel preparation.~        -  After gastric cancer surgery, they start sips of water on postoperative first day, and~          they are discharged once they exhibit at least three times soft diet without specific~          complaint and had normal clinical status and physical examination.~   "
146955|NCT01642940|"~     This is a prospective, randomized, single-center, single blind, investigator initiated, two~     period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS),~     treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected~     to percutaneous coronary intervention (PCI), will be randomized after a baseline platelet~     reactivity (PR) assessment (24 hours post PCI) while under clopidogrel in a 1:1 ratio to~     either prasugrel 10mg or ticagrelor 180mg for 15 days followed by crossover directly to the~     alternate therapy for an additional 15 days without an intervening washout period.~   "
146956|NCT01642927|"~     A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and~     post Left Ventricular Assist Device (LVAD) patients.~   "
146957|NCT01642914|"~     The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with~     placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This~     study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients~     who are eligible will be randomized to one of two doses of linaclotide or placebo for 12~     weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency,~     as well as other abdominal and bowel symptoms of CC.~   "
146958|NCT01642901|"~     Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture~     prevention and the associated morbidity of bed rest and further secondary complications.~     Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more~     effective than other agents in reducing bone mass resorption and leg fractures in~     post-menopausal women, but has not been studied in patients with acute SCI. This will be a~     randomized, double-blind, placebo-controlled trial of IV ZA to prevent bone loss early after~     SCI. Up to 48 subjects will be randomized to receive a one-time dose of 5 mg of IV ZA versus~     placebo within 21 days of an SCI.~   "
146959|NCT01642888|"~     Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and~     therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.~      The new skin test is named C-Tb. Like the current tuberculin skin test, PPD, the C-Tb test is~     injected just under the skin and will, when positive, show redness and/or swelling at the~     injection site while a negative test will leave no reactions. The investigators hope that~     this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test~     e.g. may show a reaction if the person tested is BCG vaccinated.~      The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB~     disease.~      With focus on age, HIV status and CD4 count the following analyses are done (in an overall~     perspective):~        -  To compare the C-Tb test to a blood test, the QuantiFERON test.~        -  To compare the C-Tb test to the PPD test that is currently being used.~        -  To assess the safety of the C-Tb test.~   "
146960|NCT01642875|"~     Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative~     complications often preclude or delay adequate oral nutrition and nutritional support may be~     required. However, the role of perioperative nutritional supplementation in well-nourished~     patients remains controversial.~      The purpose of this study is to compare the influence of early enteral and oral nutrition on~     postoperative course and complications after pancreatoduodenectomy.~      96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral~     nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive~     standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be~     started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated~     level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and~     oral intake will be advanced as tolerated.~   "
146961|NCT01642862|"~     The inter- and intra-variability in the pharmacokinetic parameters of different formulations~     and doses of simvastatin in healthy subjects and in subjects with celiac disease in remission~     will be evaluated. Additionally, baseline values of pharmacokinetic parameters of simvastatin~     for both study groups will be determined.~   "
146971|NCT01642732|"~     The purposes of this study are to:~        -  Determine the safest and highest dose of the study drug RAD001 (Everolimus) that can be~          taken in combination with hormonal and radiation therapy in men with high risk prostate~          cancer.~        -  Evaluate changes in patient reported quality of life~        -  Evaluate biomarkers from prostate tumor samples. Biomarkers are various traits which can~          be used to identify the progress of a disease or condition, which can help researchers~          determine the effect the study treatment has on the tumor. Biomarkers can also help~          determine areas for further research.~   "
147170|NCT01640093|"~     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the~     medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet~     formulations compared with the current commercial abiraterone acetate tablet formulation in~     healthy male participants, under fasted conditions, at a single dose of 1000 mg.~   "
146962|NCT01642849|"~     This study will assess the effect of high protein (HP) and high carbohydrate (HC) diets on~     weight loss and other metabolic parameters.~      Rationale: The prevalence of obesity is on the rise in the US. The health hazards of obesity~     have been well established. The detrimental effects of obesity on cardiovascular, metabolic~     and psychological parameters as well as the excess cost to the national health budget are~     astounding. One way of treatment and prevention of obesity has been the use of diet and~     exercise. In the absence of well-established superiority of one diet over another, different~     scientifically unproven diets are in common use. A palatable diet providing satiety as well~     as all essential nutrients may go a long way in treating over-weight individuals. Another~     factor has been the long-term adherence to such weight loss regimens, which in general have~     been poor. Protein diets have been known to provide greater satiety and reduced energy intake~     than carbohydrate diets, but definite long-term studies are sparse. For this study the~     investigators will recruit and study 24 normal, pre-menopausal obese women (12 on HP diet and~     12 on HC diet), and compare their weight loss and changes in metabolic parameters between the~     two diets.~   "
146963|NCT01642836|"~     Stanford Goals is a large-scale, community-based randomized controlled trial of an~     innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to~     treating overweight and obese children. Primary Research Question: Will a 3-year, innovative,~     interdisciplinary, multi-component, multi-level, multi-setting (MMM) community-based~     intervention to treat overweight and obese children significantly reduce BMI compared to an~     enhanced standard care/health and nutrition education active comparison intervention?~   "
146964|NCT01642823|"~     Many children with the childhood cancer, Retinoblastoma, have surgery to remove the tumor and~     sometimes the entire eye. The purpose of this study is to collect the extra tissue from~     patients who undergo tumor removal for laboratory experiments that will help us understand~     not only what occurs in retinoblastoma cells but also how cells normally function. Some of~     these studies will include an evaluation of how cells control the way that genes are~     expressed, how cells know to become retinal cells, how cells remain retinal cells, how~     cells lose their identity as retinal cells, what changes make retinoblastoma cells different~     from normal retinal cells, and what changes make some retinoblastomas worse than others.~   "
146965|NCT01642810|"~     A recent study published by the Canadian Pain Society estimated the direct health care costs~     of chronic pain to be about 6 billion dollars. Over 1/3 of all Canadians reported that they~     either missed work or experienced reduced productivity due to chronic pain. Fibromyalgia~     Syndrome (FMS)is a condition that affects up to 10% of the Canadian population, many of whom~     are still in the prime of their lives. While pain and fatigue are prominent symptoms, FMS~     sufferers often experience sleep disturbance, gastrointestinal upset, chronic headache,~     memory and thinking problems, and depression. Standard treatments focus on medication and~     physical exercise but are not always successful. Acceptance-Based behavioural therapy (ABBT)~     is a relatively new approach that has been effective not only in treating mental health~     concerns such as anxiety and depression, but also other medical conditions such as diabetes~     and chronic pain. A novel ABBT for FMS was developed and pilot tested with a small group of~     participants. The results of this preliminary study were promising. Unfortunately, many~     people cannot adequately access available treatment due to long wait lists, prohibitive~     costs, or time/location constraints. Online treatments may offer improved access to care~     without reducing the effectiveness of treatment. Therefore, the ABBT for FMS used in the~     pilot study is being adapted to an online format and will be evaluated with a larger group of~     participants. A wait-list/control group will be employed to evaluate the effectiveness of the~     online treatment as compared with treatment-as-usual. If found effective, this treatment~     would offer patients easier access to care at a significantly reduced cost to the health care~     system.~   "
146966|NCT01642797|"~     i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted~     mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations~     compared to WLE with standard biopsy protocol.~      ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with~     standard biopsy, can reduce the number of biopsies needed per patient for detection of~     gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.~      iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric~     IM/IN/CA.~   "
146967|NCT01642784|"~     Objective of this registry study is to compare strategy of complete vs. target lesion-only~     primary PCI (percutaneous coronary intervention) in IRA (infarct related artery) in STEMI (ST~     elevation myocardial infarction) patients.~   "
146968|NCT01642771|"~     Recent clinical studies showed that triple-negative breast cancer patients (ER-/PR-/HER2-)~     may benefit more from Capecitabine chemotherapy. However, the optimum post-operative adjuvant~     Capecitabine chemotherapy regimen has not been determined for Chinese population with~     triple-negative breast cancer. Thus it's necessary to conduct a multi-center Phase III~     clinical trial to verify efficacy and safety of Capecitabine in the treatment of~     triple-negative breast cancer. In this study, a prospective, randomized, open, multi-center~     Phase III clinical study was conducted to compare efficacy and safety of sequential Docetaxel~     followed by Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential Docetaxel and~     Capecitabine followed by Capecitabine/Epirubicin/Cyclophosphamide (XEC) as post-operative~     adjuvant chemotherapy in the treatment of triple-negative breast cancer in Chinese~     population.~   "
146969|NCT01642758|"~     Beta thalassemia intermedia syndromes are genetic anemias caused by mutations which reduce~     production of beta globin, a major component of adult hemoglobin A, the protein which~     delivers oxygen throughout the body. Patients suffer from poor growth, fatigue, heart~     failure, endocrine deficiencies, and eventually, many require chronic blood transfusions.~     There is no approved therapeutic for the deficiency of beta globin chains in beta~     thalassemia.~      This trial will study an oral therapeutic which stimulates production of fetal globin, an~     alternate type which is produced by all humans, but is normally switched off in infancy. This~     type of globin can compensate for the missing protein in beta thalassemia.~   "
146970|NCT01642745|"~     The study will compare the airway responses to two bronchoconstricting agents, mannitol and~     methacholine.~   "
147171|NCT01640080|"~     The purpose of this study is to assess the efficacy of esketamine compared with placebo in~     improving symptoms of depression in patients with treatment resistant depression.~   "
146972|NCT01642719|"~     Higher rates of mortality have been found both in short sleepers (< 6 hr/night) and long~     sleepers (> 8 hr/night), but there has been little experimental investigation of the effects~     of chronic, moderate sleep loss in long or average sleepers. Some scientists argue that older~     adults might be particularly vulnerable to negative effects of sleep loss, whereas other~     scientists argue that many older adults spend too much time in bed, and that moderate~     reduction of time-in-bed could help increase the quality of their sleep, and could even~     promote health and longevity, particularly in long sleepers. At 4 sites across the US, we~     will conduct a large (200 people), randomized, controlled, 5- year study to examine whether a~     1-hour reduction of time spent in bed for 12 weeks has negative or positive effects on~     multiple health-related outcomes, including inflammation, sleepiness, body weight, mood,~     glucose regulation, quality of life, incidence of illness, and incidence of automobile~     accidents in older long sleepers as compared to older average sleepers.~   "
146973|NCT01642706|"~     B cells are known to play an important role in auto-immune diseases by activating T cells,~     secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells~     named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis~     in mouse models. Bregs have also been identified in humans.~   "
146974|NCT01642693|"~     The purpose of the study is evaluate the histological changes of the dentinal-pulp complex~     and root resorption in maxillary premolars with intrusive orthodontic movement under a low~     power laser effects.~   "
146975|NCT01642680|"~     The number of long-term cancer survivors is growing. As a result, treatment-related morbidity~     - such as cardiovascular disease, metabolic syndrome, functional decline and fatigue - is~     impacting quality of life and impairing survival. Metabolic syndrome in the general~     population is currently treated with lifestyle advice to increase physical activity (PA) and~     reduce caloric intake. This approach is still underused as standard care for cancer~     survivors. The aim of this study is investigate whether a tailored PA program that starts~     early (during curative chemotherapy with cardiovascular toxic potential) is superior in terms~     of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular~     morbidity to a program that starts late (after completion of chemotherapy).~   "
146976|NCT01642667|"~     The aim of this study is to elucidate the efficacy and safety of pharmacoinvasive therapy by~     using prourokinase (prouk), a unique fibrin-specific agent, in patients with ST-segment~     elevation myocardial infarction (STEMI)~   "
146977|NCT01642654|"~     Objectives:~      The purpose of this research was to assess modifications caused by a concurrent water~     exercise program on plasma nitrite (NO3), cerebral vascular resistance and cholesterol in the~     elderly and analyze the correlations between these variables after intervention.~      Methods The sample was composed of 40 women mean age 69,21 ±5,27 years old, divided into an~     intervention (WG) and control group (CG). It was to measure nitrite concentration (NO3) by~     the Griess reaction; internal cerebral arteries were assessed by Doppler ultrasound to~     determine the resistivity index and Cholesterol was determined using the colorimetric~     enzymatic method and test kit. Intervention with water exercise program consisted of three~     weekly sessions for 16 weeks.~   "
146978|NCT01642641|"~     The purpose of the present study is to determine: 1) the efficacy of 2 periodontal surgical~     procedures, the conservative simplified papilla preservation technique and the more resective~     open flap debridement with osseous recontouring, in the treatment of chronic periodontitis in~     terms of clinical, radiographic, microbiological, immunological and PROMs, comparing them to~     non-surgical subgingival debridement and 2) if possible, determine the surgical procedure~     which leads to pocket elimination or to the lowest number of residual pockets.~   "
146979|NCT01642628|"~     Intuitively, the investigators surmise the initial and subsequent viewing of a breast site~     following mastectomy may be traumatic. A qualitative study on the experience of viewing self~     in the mirror for a woman who has had a mastectomy has confirmed the experience is unique for~     each individual, and may well be difficult. This research study aims to determine if these~     difficult moments may be buffered by a mirror intervention providing women who are scheduled~     for a mastectomy with a hand held mirror, instructions by a Oncology Nurse Navigator (ONN) on~     how to use the mirror in initial and subsequent dressing changes, and offering to discuss any~     concerns or questions.~      The purpose of this study is to evaluate the feasibility of a nursing mirror educational~     intervention and determine if it is of potential value for women scheduled for a mastectomy.~     Results from this pilot study will help determine whether the research design, setting,~     sample, instruments, data collection and data analysis are appropriate and practical for a~     larger study.~      Hypothesis~      Women, ages 18 and over, who have had a mastectomy, and receive a planned pre-operative~     education and self-reflection intervention will have relatively improved anxiety, body image,~     depression and emotional well-being scores one to three weeks post-operatively as compared to~     those who received usual care.~   "
146980|NCT01642615|"~     The purpose of this study is to assess the safety and effectiveness of treatment with once~     daily oral administration of dexlansoprazole delayed-release capsules in adolescents with~     erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.~   "
146981|NCT01642602|"~     The purpose of this study was to assess the safety and effectiveness of once daily oral~     administration of dexlansoprazole delayed-release capsules in adolescent participants with~     symptomatic non-erosive gastroesophageal reflux disease (GERD).~   "
146982|NCT01642589|"~     The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in~     support of registration of the vaccine in South Korea.~      Primary Objective:~        -  To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y~          and W-135, 28 days after a single dose of Menactra®.~      Secondary objectives:~        -  To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion~          rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine~        -  To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.~        -  To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers~          before and 28 days after a single dose of Menactra® or Adacel® vaccine.~   "
146983|NCT01642576|"~     This study aims to compare the effects of 8 months of diet modification, with or without~     exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation and~     quality of life in obese men.~   "
146984|NCT01642563|"~     Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and~     severity after transfusion of standard platelets versus platelets prepared with two~     commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of~     standard versus PRT platelets. The two technologies will be analyzed separately.~      Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets~     versus incidence in recipients of control (standard) platelets.~      Secondary endpoints: time to the first grade 2 or greater bleeding event after the first~     study transfusion; proportion of transfusions given to treat breakthrough bleeding; number of~     days with grade 2 or greater bleeding during the period of platelet transfusion support;~     number of platelet units transfused and total dose of platelets transfused per day of~     thrombocytopenic platelet support; proportion of patients with acute transfusion reactions;~     post-transfusion platelet count increments~      Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization,~     frequency of clinical refractoriness to platelet transfusion with demonstrated HLA~     alloimmunization, frequency of clinical refractoriness to platelet transfusion that is~     persistent during the period of platelet support in the absence of HLA or human platelet~     antigen (HPA) alloimmunization~      Patients will be evaluated for 4 weeks after randomization.~   "
146985|NCT01642550|"~     The purpose of this study is to determine if administration of RM-131 is effective in~     improving appetite and gastrointestinal symptoms leading to the recovery of patients with~     anorexia nervosa in the outpatient setting.~   "
146986|NCT01642537|"~     The purpose of this study is a feasibility study for the Rhythmia Medical Mapping System and~     Mapping Catheter on patients undergoing catheter ablation procedures for the treatment of~     cardiac tachyarrhythmias.~   "
146987|NCT01642524|"~     The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present~     with an injury to their head which makes them unconscios. The study compares two different~     fluids given to the patient in the out of hospital setting by a paramedic. The two fluids are~     salt water (standard treatment) versus a higher concentration of salt water mixed with a~     sugar (study fluid). The patients have an equal chance of receiving either fluid and the~     paramedic and the patient and the treating trauma surgeon do not know which fluid was~     provided in the out of hospital setting.~   "
146988|NCT01642511|"~     In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also~     the first-echelon nodal drainage site for metastasis and provides important prognostic~     information in breast cancer patients. The internal mammary sentinel lymph node biopsy~     (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But~     the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is~     carried out to improve the visualization rate of IMSLN with modified techniques: (1) The~     radiotracer is injected intraparenchymally into 2~4 quadrants of breast. (2) The radiotracer~     is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic~     guidance.~   "
146989|NCT01642498|"~     The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in~     patients with treatment-resistant hypertension.~   "
146990|NCT01642485|"~     Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough~     electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval,~     which may affect pharmacokinetics (PK) and/or pharmacodynamics (PD) of the study drug.~     However, there is no published data clarifying this issue. There is also a paucity of data~     investigating ethnic differences of the effects of medicines on QTc.~      The aims of the study were to compare the effect of different food contents to placebo on the~     changes in ECG and to demonstrate the effect of insulin, C-peptide and glucose on the ECG.~     This was done by giving different treatments on separate days, which included intravenous~     insulin, a high carbohydrate breakfast [>70%], and a calorie reduced low carbohydrate~     American FDA standard breakfast. Moxifloxacin 400 mg was used as a positive control and was~     given with and without food to Caucasian and Japanese volunteers to investigate racial~     differences.~   "
146991|NCT01642472|"~     This is a phase III, multicentre, long-term open-label extension of the phase III study:~     Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III~     extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month~     open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl~     extension 2 (PGL11-024).~      This proposed study consists of 4 further consecutive courses of 3 months (84 days) open~     label ulipristal acetate 10mg once daily treatment each separated by a drug free period.~   "
146992|NCT01642459|"~     The investigators hypothesis that aneurysms and stenoses will be decreased if the direction~     of inserted arterial needle were same as the direction of blood flow, when compared to the~     opposite direction puncture.~   "
146993|NCT01642446|"~     There is no consensus about the optimal treatment of hepatocellular carcinoma (HCC) with~     cirrhotic portal hypertension, While this group of patients are classified as hepatectomy~     contraindication according to guidelines from National Comprehensive Cancer Network (NCCN)~     and American Association for the Study of Liver Diseases (AASLD). With improvement of~     surgical technique, preoperative evaluation, and perioperative management,especially the~     Precise Hepatectomy Technique, more and more studies confirmed the safety of surgical~     intervention to hepatocellular carcinoma (HCC) patients with cirrhotic portal~     hypertension.However, most of the previous studies were either retrospective or with small~     samples.~      The investigators project is a prospective randomized controlled trial, planning to compare~     the safety, efficacy and quality of life between precise hepatectomy and combined~     interventional treatment on hepatocellular carcinoma (HCC) with cirrhotic portal~     hypertension, to make a further understanding of optimal strategy.~   "
147001|NCT01642342|"~     This study is about an experimental drug called sEphB4-HSA (recombinant albumin fusion~     protein sEphB4-HSA). This research study will be the first time sEphB4-HSA is given to~     people. sEphB4-HSA prevents tumor cells from multiplying and blocks several compounds that~     promote the growth of blood vessels that bring nutrients to the tumor. sEphB4-HSA has shrunk~     colon, lung, breast, glioma, melanoma, prostate and Kaposi's sarcoma tumors in mice~   "
147002|NCT01642329|"~     The purpose of this Registry is creating a database management that allows continuous~     monitoring characteristics, evolution, prognostic indicators and management of patients with~     ACS admitted in Portuguese Hospitals, and identify the appropriateness of clinical practice~     recommendations for diagnosis and treatment of ACS and monitor its evolution.~   "
146994|NCT01642433|"~     The most likely outcome of smoking cessation attempts is relapse, underscoring the need to~     advance novel treatments. Preclinical research shows that the noradrenergic system is~     critical for modulating drug-seeking behavior and recent findings indicate that the~     α1-adrenergic antagonist prazosin reduces nicotine self-administration and reinstatement.~     Presently, data on prazosin's effects on nicotine-related behaviour in humans is lacking. An~     efficient method for screening novel smoking cessation medications is to integrate human~     laboratory paradigms in the context of brief, randomized trials of smoking cessation that~     include smokers motivated to quit. This study aims to provide an initial test of prazosin for~     smoking cessation by implementing a brief, randomized trial that will include both human~     laboratory and clinical phenotypes. This approach will allow an efficient but sensitive~     method for medication screening that maximizes clinical validity.~   "
146995|NCT01642420|"~     Alzheimers disease (AD) is the most common course of cognitive decline and thereby the course~     of more than half of all cases of dementia. A proper AD diagnosis is rested on a number of~     examinations and tests, which combined can make AD diagnosis likely. But no single test or~     examination can unambiguous determine whether the patient has AD or not. Comparatively no~     examination or test can with accuracy predict whether a healthy person or a person with only~     mild cognitive (MCI)impairment in time will evolve AD.~      Quantitative Electroencephalography (qEEG), cerebrospinal fluid (CSF) biomarkers, linear CT~     analyses and Timed Up and Go - Dual Task (TUG-DT) are relatively inexpensive and and widely~     available diagnostic methods, which have the potential to diagnose AD at an early stage in a~     reliable accurate way. But they also have the potential to predict which patients diagnosed~     with MCI have particular risk of developing dementia.~      The purpose of the study is to investigate the relations between qEEG, CSF biomarkers, CT~     analyses and TUG-DT outcome and clinical features in healthy persons as well as patients with~     MCI and AD Furthermore to investigate whether qEEG or CSF biomarkers can predict which~     patients with MCI will in time evolve AD.~   "
146996|NCT01642407|"~     Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease.~     In many patients, the course of PAH is a steady deterioration and reduced life expectancy.~      Sildenafil was approved by the European Commission for the treatment of PAH in pediatric~     patients in May 2011, making it the first agent to be approved for the treatment of children~     with PAH. The approval was based on the largest placebo-controlled study to be conducted in~     this population. The recommended dose in pediatric patients aged 1 year to 17 years old is 10~     mg TID in patients ≤ 20 kg and 20 mg TID for patients > 20 kg. Higher doses are not~     recommended in pediatrics patients.~      This study is an open-label, multi-center study to investigate safety, efficacy and~     pharmacokinetics of sildenafil citrate in Japanese pediatric patients with PAH.~   "
146997|NCT01642394|"~     Main objective:To evaluate the effectiveness of the Diabetes Self-Management Programme~     (DSMP) on the metabolic control, cardiovascular risk reduction, quality of life and~     self-efficacy in adult patients with type 2 diabetes, compared with current standard care of~     patients with type 2 diabetes, in the context of Osakidetza's Primary Care network.~      Secondary objectives:~        -  To evaluate the impact of the implementation of DSMP in the use of health services.~        -  To assess the impact of DSMP in the cost of treatment of the involved population.~        -  To evaluate the improvement in physical activity and diet patterns among the~          participants.~        -  To describe the feasibility of implementing the DSMP in the Basque Country's primary~          health care system Methodology: Randomized clinical trial in which patients diagnosed~          with type 2 diabetes aged between 18 and 80 years pertaining to 4 primary regions of the~          Basque country, who agree to participate in the study, will be randomly assigned to two~          groups: the intervention group (the DSMP programme) and the control group. The~          intervention will be performed by trained patients with type 2 diabetes and health~          professionals and it will consist in 6 group sessions of two and a half hours each, on a~          weekly basis with a overall duration of 6 weeks. The session content includes techniques~          for dealing with problems, promotion of exercise, nutrition concepts, proper use of~          medication, effective communication and basic knowledge about diabetes and its~          complications. The sessions are supported with educational material. The main outcome is~          the improvement of HbA1c (glycated hemoglobin) levels. Secondary outcomes are reduction~          of cardiovascular risk, increase of quality of life and self-efficacy. The results will~          be analyzed at 6, 12 and 24 months after the intervention.~      Hypothesis: An educational intervention on patients with type 2 diabetes mellitus based on~     the program DSMP conducted by previously trained lay persons and health professionals,~     improve metabolic control as measured on a 0.5% decrease in Hb A1c (Clar, 2010),compared to~     regular health education. On the other hand, it is expected to see improvements in the~     quality of life for these patients. The intervention may reduce the weight and cardiovascular~     risk due to changes in the physical activity and diet patterns, getting to a more appropriate~     use of health services and medication. It is expected that changes in the variables occur 6~     months after the intervention and remain over the time~   "
146998|NCT01642381|"~     The purpose of this study is to investigate the critical components of motivational~     interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic~     drinking. The study will disaggregate MI into its component parts and test full MI compared~     to MI without its directive strategies. This study will test whether the directive elements~     of MI are critical or whether MI effects may be attributable solely to its Rogerian,~     non-directive components. For more information, go to http://caspirnyc.org/p_motion.html~   "
146999|NCT01642368|"~     The goal of the Optimum Omega-3 (OO3) Diet Study is to assess whether swapping specific food~     ingredients in diets can significantly change omega-3 blood profiles with 10 weeks of a 7-day~     menu in men and women (18-40 years old). We want to look at the effect on a person's response~     to cognition, satiety and physical fitness. Investigators think that low omega-6 and moderate~     omega-3 fatty acid diets may regulate emotional response and help to return to normal after~     load carrying activities. We plan to test the effects of improving overall fatty acids on~     emotional response, satiety, and physical fitness levels by a diet with an improved omega-3~     to omega-6 diet compared to a control diet.~   "
147000|NCT01642355|"~     The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults~     to Achieve Cardiovascular Targets) is to determine the best management strategy for patients~     undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will~     enroll 400 patients post-cardiovascular intervention. The study will compare different~     cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult,~     and (3) cardiovascular prevention consult with a behavioral intervention program over a~     6-month period. The trial hypothesis is that for patients undergoing a cardiovascular~     intervention, a prevention consult and behavioral intervention is superior to usual care in~     reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary~     endpoints include other lipid values, metabolic risk, smoking cessation, physical activity,~     nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin~     enrollment in the June of 2012.~   "
147038|NCT01641848|"~     The primary objective of this study is to collect preoperative, operative and postoperative~     clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total~     Ankle Prosthesis.~   "
147039|NCT01641835|"~     Collect OCT data to evaluate the range and age trend of ocular measurements.~   "
147003|NCT01642316|"~     Testing and teaching are completely interrelated in education process; using various kinds of~     tests teachers are able to anticipate about the strong and weak points of learning in~     students, their progress and their accomplishment. The influence a test on teaching and~     learning is commonly referred to as washback. Testing washback is a twisted concept that~     becomes even more complex under a various interpretations of the washback phenomenon on~     teaching and learning. This study aimed to describe washback behaviors of students, in the~     low stakes testing in an ESP environment in two-fold. First, the study investigated the~     effects of different formative tests on Iranian medical students' English reading~     comprehension achievement. Secondly, the study explores the effects of washback on the~     students' attitudes toward English reading comprehension. The pre- and post-tests and one~     questionnaire were used to collect the data from Iranian medical students. Data were analyzed~     by paired t-test, t-test, and Mann-Whitney U test.~   "
147004|NCT01642303|"~     Improvement of the internet and its tremendous growth has caused significant progress in~     transformation of information. Nowadays in any place of the world and in any time of the day~     by accessing through internet every student can use different kinds of information in World~     Wide Web which let him to make the best decision what, how and when to study. One of these~     educational technologies which are beneficial to learners is vodcast or video recording which~     are accessible through the internet.This paper is going to examine the listening~     comprehension in EFL learners and whether it may be improved by using vodcasts. So106~     language learners of four different classes of Iranian higher intermediate in an English~     institute were chosen for this study. These learners were pre-tested by IELTS Listening~     Comprehension. Two classes were chosen as subject group which consisted of 54 learners. The~     remaining two classes were chosen as control group which consisted of 52 learners. Both~     groups were taught Listening Impact book, but students in subject group were provided some~     vodcasts based on the topic of their lessons. After 12 weeks of teaching both groups were~     post-tested.listening comprehension will be compared using independent t-test and paired~     t-test.~   "
147005|NCT01642277|"~     No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection~     (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as~     evidenced by routine microbiology cultures. Recent work by the group on the genitourinary~     microbiome (GUM) has shown that female urine, even in the absence of culture evidence of~     bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine~     and sequenced to identify bacterial species present in urine. From this the investigators can~     hypothesize that urinary bacteria contribute to urinary symptoms and that there is a~     difference in the bacterial communities in the urine of women who respond to Solifenacin, a~     drug used to treat OAB, versus those that do not.~   "
147006|NCT01642264|"~     The primary aim of this study was to develop an interactive Internet-based program~     (WeBREATHe: Web-Based Respiratory Education About Tobacco and Health) to train pediatric~     respiratory therapists and nurses to provide brief, hospital-based tobacco cessation~     interventions to parents of pediatric patients. The WeBREATHe program was based on a Phase I~     prototype which was evaluated with 50 pediatric respiratory therapists and nurses.~      In Phase II, the investigators redesigned and expanded the program with input from 50~     educators, nurses and respiratory therapists from Cincinnati Children's Hospital Medical~     Center. Then the investigators evaluated the Phase II program in a randomized trial in which~     215 respiratory therapists and nurses from two large, urban children's hospitals were~     randomly assigned within hospital to either the Intervention (Training) Condition, or to a~     Delayed Treatment (Training) Control condition.~      Participants' demographic and tobacco use history were measured at baseline, and tobacco~     cessation intervention behaviors, attitudes, knowledge, perceived barriers, and self-efficacy~     regarding delivery of a tobacco cessation intervention were measured at baseline, 1 week~     post-training, and at 3 months post-training. User satisfaction measures were also collected~     at 1 week post-training from Intervention Condition participants. The investigators~     hypothesized that participants in the Intervention Condition would have increased tobacco~     cessation behaviors, positive attitudes and self-efficacy, and decreased perceived barriers~     than participants i the Delayed-Treatment Control Condition.~      Following evaluation, the investigators developed a final version of the interactive training~     program and created the administrative infrastructure for a marketable product.~   "
147007|NCT01642251|"~     This randomized phase I/II trial studies the side effects and best dose of veliparib when~     given together with or without cisplatin and etoposide and to see how well they work in~     treating patients with extensive stage small cell lung cancer or large cell neuroendocrine~     non-small cell lung cancer that has spread to other parts of the body. Drugs used in~     chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving cisplatin and etoposide with or without veliparib may work~     better in treating patients with extensive stage small cell lung cancer or metastatic large~     cell neuroendocrine non-small cell lung cancer.~   "
147008|NCT01642238|"~     The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin and~     bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and~     bivalirudin).~   "
147009|NCT01642225|"~     Purpose of the study:~      The specific aims of this study are to evaluate overall efficacy and safety of the~     pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors~     affecting treatment outcomes in order to improve patient selection and treatment protocols~     for future patients.~   "
147010|NCT01642212|"~     This is a clinical trial to test an experimental drug for the treatment of Eosinophilic~     Esophagitis (EoE)~   "
147011|NCT01642199|"~     The primary aim of this study is to determine whether reduced intensity behavioral weight~     loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than~     rBWL + Mentor Health Coaches and rBWL alone.~   "
147212|NCT01639534|"~     The purpose of the study is to determine if a new blood test can help the doctor determine if~     there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the brain.~     In this study the investigators are analyzing your blood for a new test that might help~     doctors decide if symptoms are from a neurologic problem.~   "
147012|NCT01642186|"~     There is no effective standard treatment for fibrolamellar liver cancer that cannot be~     removed by surgery. The investigators want to find out what effects, good and/or bad, 3 drugs~     called letrozole, leuprolide and everolimus will have on cancer. All of these drugs are FDA~     approved for the treatment of different cancers. Letrozole and leuprolide stop the body from~     producing estrogen, a normal hormone produced by the body. Too much estrogen may help~     fibrolamellar liver cancer grow. Everolimus is a drug that may block other chemicals in the~     body that can help cancer grow. The combination of letrozole and leuprolide plus everolimus~     may work well together.~   "
147013|NCT01642173|"~     The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an~     integral role in early atherosclerosis, and contributes to the mechanism of coronary~     endothelial dysfunction and to the structural and mechanical properties that characterize~     plaque vulnerability. Thus, the investigators study will characterize prospectively the~     correlation between the functional and structural vascular wall properties, and the activity~     of the Lp-PLA2 pathway.~   "
147014|NCT01642160|"~     Does an internet based text or email interaction and education improve CPAP compliance for~     patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.~   "
147015|NCT01642147|"~     Few studies look into cerebral blood flow (CBF) changes during emergence from general~     anesthesia for craniotomy. The purpose of this study is to demonstrate CBF changes during~     emergence from general anesthesia for craniotomy, through monitoring blood oxygen saturation~     of jugular vein bulb and transcranial Doppler.~   "
147016|NCT01642134|"~     The purpose of this study is to determine the incidence of major vascular events (ischemic or~     haemorrhagics) at the third month after initiation of the antithrombotic treatment (oral~     anticoagulation or dual antiplatelet therapy) in both arms followed TAVI.~   "
147017|NCT01642121|"~     This laboratory study is looking into biomarkers in samples from younger patients with acute~     myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer~   "
147018|NCT01642108|"~     Type 2 diabetes mellitus (T2DM) results from early phase insulin secretory defect and insulin~     resistance. Studies have shown that most of the populations in which insulin resistance is~     considered to be the primary pathogenetic cause of diabetes, have a higher degree of obesity~     than those of primary insulin defect. Meanwhile, defective early insulin secretion plays a~     predominant role in the non-obese subtype of T2DM which includes majority of Japanese~     patients.~      Sitagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor as indicated for the treatment of~     T2DM. Sitagliptin increases plasma concentrations of active glucagon-like peptide-1 (GLP-1)~     and active glucose-dependent insulinotropic peptide (GIP) two- to three-fold in patients with~     T2DM. The effect of sitagliptin on GLP-1 results in lower fasting and postprandial glucose~     concentrations through increases in glucose dependent insulin release and suppression of~     inappropriate glucagon secretion. Namely, several mechanistic studies using standardized meal~     showed that sitagliptin improved glucose control with decreased glucagon levels and increased~     insulin concentration in obese or overweight T2DM patients with BMI > 25 kg/m2. However, how~     sitagliptin affects islet function, including glucagon secretion in non-obese patients with~     low insulin secretion are not known. Therefore, the investigators will examine the effect of~     sitagliptin on glycemic control and the mechanism involved using a standardized test meal in~     non-obese Japanese patients with T2DM whose BMI levels are < 25 kg/m2.~   "
147019|NCT01642095|"~     This laboratory study is looking into biomarkers in samples from younger patients with kidney~     cancer. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors find better ways to treat cancer.~   "
147020|NCT01642082|"~     This phase II trial studies how well dalantercept works in treating patients with endometrial~     cancer that has come back or is persistent. Dalantercept may stop the growth of endometrial~     cancer by blocking blood flow to the tumor.~   "
147021|NCT01642069|"~     This laboratory study is looking into genes in samples from younger patients with acute~     megakaryoblastic leukemia (AMKL). Studying samples of blood, tissue, and bone marrow from~     patients with cancer in the laboratory may help doctors learn more about changes that occur~     in RNA and identify biomarkers related to cancer~   "
147022|NCT01642056|"~     Background:~        -  Mitochondria are the parts of cells that help produce energy. Metabolism is the process~          by which the body uses energy to help cells grow and reproduce. Metabolic and~          mitochondrial disorders affect the body s ability to produce and store energy. These~          disorders can cause a wide variety of problems, but most often they affect the muscles~          and the brain, where energy requirements are high. Treatment is difficult because the~          exact source of the problem is hard to detect.~        -  EPI-743 is a new drug that is based on vitamin E. Tests have shown that it can help~          improve the function of cells with mitochondrial problems. It may be able to treat~          people with genetic disorders that affect metabolism and mitochondria.~      Objectives:~      - To see if EPI-743 can improve energy production and use in people with mitochondrial or~     metabolic disorders.~      Eligibility:~      - Children between 2 and 11 years of age who have metabolic or mitochondrial problems.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  The study will last about 13 months. Participants will have seven 3- to 5-day inpatient~          study visits about 3 months apart.~        -  Participants will take either EPI-743 or a placebo for the first 6 months of the study.~          After 6 months, there will be a 1-month rest period. Then, those who received EPI-743 in~          the first 6 months will take the placebo for the next 6 months. Those who had the~          placebo will take EPI-743.~        -  During each inpatient study visit, participants will have a physical exam. A 24-hour~          urine collection will be obtained. Blood samples will also be taken. Imaging studies and~          other tests may be performed as directed by the study researchers.~   "
147023|NCT01642043|"~     Greater trochanteric pain syndrome (GTPS) is a common cause of musculoskeletal pain.~      The primary aim of this study is to describe the soft tissue and bony structural ultrasound~     (US) findings identified in the lateral hip and iliotibial band (ITB) in patients presenting~     with greater trochanteric pain syndrome (GTPS) in an outpatient rheumatology clinic.~   "
147024|NCT01642030|"~     Pain is very common in persons with a history of addiction, but few studies have examined the~     best treatment of pain in this population. This is a study to determine the pain relief~     provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons maintained~     on stable doses of methadone or buprenorphine. Experimental sessions will require overnight~     stays on a residential research unit. In these sessions, persons will be exposed to standard~     experimental pain techniques at baseline and then rate the relief (if any) provided by the~     study medication when exposed to the same techniques. Persons will be asked to participate in~     2 or 3 sessions, each separated by at least 7 days.~   "
147025|NCT01642017|"~     This is an open-label, multicenter, non-randomized, phase 1 dose escalation clinical trial to~     determine the MTD (Maximal Tolerated Dose) of Pazopanib in a population of frail elderly~     patients, selected according to the International Society of Geriatric Oncology~     (SIOG)classification (Group 2).~      It is expected that a total number of 30 patients maximum will be enrolled in the study on 30~     months : 18 months accrual - 12 months follow up.~      Eligible patients will be enrolled into a standard 3+3 design with a starting dose of~     Pazopanib administered orally at 400 mg per day, in 28-day cycles. Then, further dose levels~     will be explored.~      Toxicity of the schedule will be assessed during the first cycle. Patients will receive study~     medication until disease progression. After treatment discontinuation, patients will be~     followed during one year.~   "
147026|NCT01642004|"~     The purpose of the study is to compare the overall survival of BMS-936558 as compared with~     Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of~     prior platinum-based chemotherapy.~   "
147027|NCT01641991|"~     A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of~     BioThrax® in varying dose regimens with the primary objective of obtaining information on~     possible dose-sparing strategies in the event of a major biothreat.~   "
147028|NCT01641978|"~     The assessment of the level of consciousness in patients admitted to intensive care units~     (ICU) can be complicated because the variables that are evaluated can be interpreted in a~     different way by different observers.~      The main objective is to determine interobserver agreement of the Glasgow Coma Scale (GCS)~     among ICU nurses and assess whether professional experience change the results. Secondary~     objective: to determine interobserver agreement in each of the three components (motor~     response, verbal and eye opening) of the GCS~   "
147029|NCT01641965|"~     Timing of initiating domiciliary no invasive ventilation (NIV) in amyotrophic lateral~     sclerosis patients remains unclear. The hypothesis of the study is that the early use of NIV,~     in the initial phase of respiratory muscle weakness, improves the prognosis of ALS patients.~      Principal objective: To evaluate the impact of early NIV in the survival of ALS patients.~      Secondary objectives:To determine the effects from early NIV in the progression of~     respiratory muscle weakness. To analyze the impact of early NIV in the quality of life of ALS~     patients. To evaluate the correlation between the FVC and other parameters of respiratory~     evaluation (maximal inspiratory pressure (MIP), sniff nasal inspiratory pressure (SNP),~     nocturnal desaturation) and their utility in the early indication of the NIV. To evaluate the~     tolerance to the early NIV.~      Methods: multicentric, randomized, open-label, controlled clinical trial with a parallel~     treatment design. Patients will be included when their FVC reaches the threshold of the 75%~     of the predicted value and will be randomized in: Group A: the NIV treatment will begin~     immediately and Group B: the NIV treatment will be started when patients fulfil at least one~     of the following criteria: (i) FVC < 50% predicted, (ii) orthopnea, and/or (iii) PaCO2 > 45~     mmHg. Follow-up visits will be done every three months with pulmonary function test,~     nocturnal pulse oximetry, quality of life and quality of sleep tests, assessment of disease~     progression (ALSFSR-R scale), tolerance and compliance with NIV.~   "
147030|NCT01641952|"~     This observational, prospective, multicenter study will evaluate the efficacy and safety of~     MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response~     or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according~     to the current standard and in line with the summary of product characteristics at a dose of~     1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.~   "
147031|NCT01641939|"~     This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and~     safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel)~     treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive~     advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized~     with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram~     per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab~     emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per~     meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per~     investigator choice). At the end of the first stage of the study, the dose and schedule of~     trastuzumab emtansine that will be used in the second stage of the study will be selected by~     an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made~     after approximately 100 participants across all three study arms have been treated for at~     least 12 weeks.~      Once a trastuzumab emtansine regimen has been selected, Stage I participants who were~     assigned to the treatment arm which was selected for Stage II of the study and participants~     who were in the standard taxane group will continue to receive their assigned treatment~     regimen. Stage I participants who were assigned to the regimen that was not selected for~     further evaluation will continue to receive their assigned regimen and will continue to be~     followed for efficacy and safety. In Stage II of the study, additional participants will be~     recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab~     emtansine or to the standard taxane therapy. Participants will receive study treatment until~     disease progression, unacceptable toxicity, initiation of another cancer therapy or~     withdrawal.~   "
147032|NCT01641926|"~     This study is being done to compare the safety and efficacy of PEG-Intron™ to that of~     PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg]~     positive or negative) who have not previously been treated with interferon.~   "
147033|NCT01641913|"~     Do patient's with eosinophilic esophagitis have increased small intestinal permeability and~     if this changes in response to topically administered esophageal steroids?~   "
147034|NCT01641900|"~     The investigators will test the hypothesis that the sleep medication, eszopiclone, can~     normalize brain activity during sleep and improve memory in patients with schizophrenia. The~     investigators will do this by measuring sleep and memory performance on two conditions~     separated by one week: taking 3 mg of eszopiclone and taking placebo. The investigators will~     study healthy subjects and chronic, medicated outpatients with schizophrenia.~   "
147035|NCT01641887|"~     The study is to test a decision aid that is designed to help patients make decision regarding~     management of their gastroesophageal reflux disease (GERD). Once the decision aid is~     constructed we will test and assess the aid on ~100 patients who have GERD to assess~     effectiveness.~   "
147036|NCT01641874|"~     The purpose of the study is to explore if a subgroup of people with osteoarthritic knees can~     be identified using the McKenzie System of Mechanical Diagnosis and Therapy.~      In the spine this subgroup, termed derangement,has been shown to respond rapidly to specific~     directional exercises.~      The trial will explore whether these derangements in the knee respond to specific exercises~     compared to a control group with no exercises and non-derangement knees given general~     exercises.~   "
147037|NCT01641861|"~     The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison~     to the conventional drilling method.~   "
147040|NCT01641822|"~     The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen~     with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in~     adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa~     (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be~     eligible for randomization in the comparative phase if they have not received non-study oral~     antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between~     Visits 2 and 3, have not developed a condition requiring hospitalization or other change in~     clinical status which, in the opinion of the investigator would preclude their ability to~     continue in the study, and have demonstrated at least 50% TIS compliance. Participants~     enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each~     cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28~     days.~   "
147041|NCT01641809|"~     The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral~     activity and tolerability in HIV-1 infected, antiretroviral naive subjects.~      This study consists of two parts:~      Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4~     treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of~     GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of~     open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse~     transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either~     abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the~     Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete~     24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1~     ribonucleic acid [RNA] <50 copies per milliliter [c/mL] before Week 24, with no signs of~     virologic rebound) will become eligible for the Maintenance Phase of this study.~      Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue~     their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily~     for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug~     ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects~     randomized to the EFV arm will continue on their randomized regimen through Week 96.~      After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to~     continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and~     until it is locally approved and commercially available.~   "
147042|NCT01641796|"~     This is an expanded access treatment protocol designed to provide a topical cream treatment~     option to military health care beneficiaries with parasitologically confirmed uncomplicated~     Cutaneous Leishmaniasis.~   "
147043|NCT01641783|"~     Gastric cancer remains one of the major causes of cancer deaths around the world,especially~     in Asia. For advanced gastric cancer,even if treated with chemotherapy,the prognosis is still~     poor, so the investigators urgently need an effective strategy to treat advanced gastric~     cancer, however, there was no recommended First-line chemotherapy for advanced gastric~     cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound (Nab) Paclitaxel~     (Abraxane，ABI-007) with high effectiveness and low toxicity had been approved in breast~     cancer as first-line chemotherapy in many countries. The investigator then initiated a~     prospective phase II clinical trial with Nab-Paclitaxel plus Capecitabine as the first-line~     treatment in advanced gastric cancer to observe the efficacy and safety.~   "
147044|NCT01641770|"~     The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS)~     plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe~     malnutrition.~   "
147045|NCT01641757|"~     Periodontitis is a destructive chronic infection of the gums, ligaments, and bone,~     predominantly caused by Gram-negative bacteria. Individuals with periodontal disease are at~     increased risk of systemic diseases. Increased prevalence of periodontal disease has been~     reported in patients with chronic kidney disease, especially in dialysis patients. Chronic~     kidney disease (CKD) is the progressive loss of kidney function over time. When kidneys loose~     their 85-90 % function, dialysis is performed. Efficacy of dialysis is checked by serum~     albumin levels. Lower-than-normal levels of serum albumin may be a sign of kidney diseases.~     Hypoalbuminemia has been demonstrated to be a strong predictor of death in chronic renal~     failure. A proposed mechanism for the effect of periodontitis on the development of kidney~     disease is systemic inflammation. The deleterious effects of systemic inflammation on kidney~     function could occur during the period of active periodontal infection and accumulate during~     the life time of the individual. This randomized control trial is designed to observe the~     effect of non-surgical periodontal therapy on serum albumin levels of patients on maintenance~     hemodialysis therapy. Patients will undergo periodontal examination and their serum albumin~     levels will be checked. Then they will be randomly divided in two groups. One group will be~     given non surgical periodontal treatment and second group will be offered late treatment.~     After 6 weeks 1st group will be reevaluated by serum albumin level and periodontal~     examination to observe the effect of non-surgical periodontal therapy. Statistical analyses~     shall be performed using SPSS software. T tests and Chi-sq tests shall be used to test~     differences according to periodontal status for continuous and categorical variables,~     respectively. The level of significance is set at p<0.05.~   "
147046|NCT01641744|"~     The study examines the effectiveness of parent-child Group Attachment Based Intervention~     (GABI) in reducing risk of maltreatment in infants and toddlers compared with parenting~     skills classes. GABI directly addresses the needs of isolated, marginalized families, with~     the goals of of enhancing parent coping and resilience, and improving parent-child attachment~     relationships.~      We hypothesize that compared to usual care, GABI will be associated with improved child,~     parent and parent-child outcomes.~   "
147047|NCT01641731|"~     Induction of oral tolerance in children allergic to cow's milk proteins is not risk-free. The~     analysis of factors that may influence the outcome is of utmost importance.~      The aim of the study is to analyse the efficacy and safety of the induction phase of oral~     tolerance induction according to specific IgE level, as well as adverse events during the~     maintenance phase.~      Patients allergic to cow's milk are to be included in an oral tolerance induction protocol.~     Patients will be grouped according to specific IgE levels in serum (ImmunoCAP) into group I~     (sIgE<3.5 kU/L), II (sIgE 3.5-17 kU/L) and III (>17-50kU/L). Allergic children with similar~     characteristics will included as a control group. Visits are established at 1, 6 and 12~     months after the induction phase. Serum specific IgE levels to cow's milk and its proteins~     will be determined at inclusion, and at 6 and 12 months visits after the induction phase.~   "
147086|NCT01641224|"~     The purpose of this study is to test the efficacy and safety of pinaverium and an herbal~     medication for irritable bowel syndrome (IBS). Pinaverium has been in many countries, but~     there is no randomized, double-blind, large sample size, and placebo-controlled study on this~     medication yet. Tong Xie Yao Fang (Formula for pain and diarrhea) is a historically and~     contemporarily used traditional Chinese medicine that can be used for IBS. The hypothesis is~     that the two remedies are effective and safe for IBS treatment when tested by modern clinical~     standards and criteria.~   "
147048|NCT01641718|"~     Inguinal hernia repairs belong to the most common surgical procedures worldwide. Increasingly~     they are performed using endoscopical techniques (laparoscopy). Many surgeons prefer to cover~     the hernia gap with a mesh to prevent recurrence. For it, the mesh must be fixed tightly, but~     tension free. During laparoscopic surgery the mesh is fixed commonly with staples or tissue~     glue. However, it is not uncommon that staples cause pain at the staple sites while moving.~     In addition, staples can cause scarring of the abdominal wall leading to chronic pain.~      Aim of the study is to provide evidence that mesh fixation with tissue glue causes less~     postoperative pain compared to fixation with staples.~      Patients with unilateral inguinal hernia will be randomized to receive either mesh fixation~     with tissue glue or staples (ratio 1:1).~      Patients with bilateral inguinal hernia will receive mesh fixation with tissue glue on one~     side and staple fixation on the other side. The side treated with tissue glue will be~     randomized (ratio 1:1).~   "
147049|NCT01641705|"~     Rheumatoid arthritis (RA) is an autoimmune disease of unknown etiology characterized by~     peripheral polyarthritis, symmetric, which leads to joint destruction and deformity. It is~     estimated that the RA reaches about 0.5% of the population. According to data from DATASUS,~     was responsible for 26,671 hospitalizations, 229 deaths and cost exceeding R$ 20 million in~     2005-2007.~      The main bodily changes are related to joint problems, however, systemic manifestations are~     also found in organs such as lung and heart. Although cardiovascular diseases are the most~     responsible of the deaths AR, pulmonary complications are common and account for 10% to 15%~     of all mortality. Anaya and colleagues point out that the pulmonary involvement contributes~     significant morbidity and mortality in these patients. Although pulmonary involvement is a~     frequent manifestation in RA, the prevalence and nature of rheumatoid lung disease has not~     yet been precisely established. Several lung disorders such as interstitial pulmonary~     fibrosis, pulmonary nodules and bronchiolitis may ocorrer1. Laitinen et al point out that~     studies of lung function appear to be a valuable helper for radiography in the evaluation of~     pulmonary involvement in connective tissue diseases. Previous studies indicate that patients~     with RA have an increased incidence of abnormal lung function, according to assessments~     including spirometry, lung volume tests and diffusion capacity of carbon monoxide.~      Thus, the main objective of this study is to analyze the respiratory mechanics of patients~     with RA. Specific objectives were to seek to understand whether a relationship exists between~     duration of rheumatoid disease and lung function in these patients.~      For this, the investigators used 18 subjects in the control group, free of pulmonary disease~     and / or heart, all nonsmokers. In the RA group, a total of 72 patients divided into 4 groups~     of 18 volunteers each, classified according to disease duration (0-5 years, 6-10 years, 11-15~     years and> or = 16 years). It is noteworthy that all patients in the RA group will also be~     non-smokers, since it is already known in the literature that smoking impairs lung function.~     All individuals will perform the function test with a trained technician and qualified to~     function. The examinations will be conducted: Forced oscillation technique and spirometry, in~     that order.~   "
147050|NCT01641692|"~     This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block~     design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with~     placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are~     currently using non-ICS controller medications. Subjects will participate in the study for up~     to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure~     adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will~     be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment~     sequence.~      A sub-group of subjects at selected sites (approximately 30% of the total population) will~     have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic~     sampling at the start and end of each treatment period. Safety assessments will include~     monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily~     PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic~     analysis.~   "
147051|NCT01641679|"~     After initial treatment of differentiated thyroid cancer patients (DTC) are followed by a~     blood test, a biomarker called thyroglobulin, in order to detect a possible recurrence.~     Nowadays patients are treated 'blindly' with high dose radioactive iodine to treat a~     suspected recurrence. However, the scan made after therapy to verify the effect of the~     treatment shows that in up to 50% the treatment could be considered as futile.~      124I - a radioactive isotope - in combination with whole body PET became recently available~     for use in the follow-up of DTC. This could make it possible before the therapy with high~     dose radioactive iodine to determine the extensiveness of the disease and whether effect of~     the therapy could be expected. Additionally, recurrent DTC lesions that do not accumulate~     iodine can be found without the futile treatment with 131I. FDG-PET (another PET modality) is~     able to detect these lesions. The value of FDG-PET before 131I treatment however has not been~     tested.~      The combination of these two diagnostic tools, 124I-PET and FDG-PET, has a potential to allow~     earlier and better restaging and selection for treatment~   "
147052|NCT01641666|"~     This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three~     times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg~     once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day)~     PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C,~     Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.~   "
147053|NCT01641653|"~     This research is being done to investigate if patients who receive a commonly used sedative~     drug, known as midazolam, are likely to have high blood sugar levels during the stressful~     period during and immediately after surgery. A sedative drug is used to relax a person~     without making them sleepy. This drug is also helpful in reducing the memory of the stressful~     experience before the anesthesiologists administers anesthesia. Everyone has glucose or sugar~     in their blood stream. This sugar gives energy to our organs to allow them to work. Since~     high blood sugar levels may be associated with complications like wound infections, the~     investigators research is being done to find if patients who receive a sedative medication~     prior to their surgical procedure have lower blood sugars during the surgery then a patient~     who does not receive the sedation. The investigators would like to know if the administration~     of this commonly used drug will help patients maintain a normal glucose level during a~     stressful period.~   "
147054|NCT01641640|"~     This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated~     interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with~     hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral~     response (SVR) 12 weeks after discontinuation of therapy (SVR12).~   "
147122|NCT01640730|"~     This study is for patients with advanced non small cell lung cancer that has progressed~     despite standard of care. The purpose of the study is to see if Kanglaite injection has any~     effect on survival.~   "
147123|NCT01640717|"~     The primary objective is to assess safety and efficacy data of Escherichia coli-derived cPMP~     in patients with molybdenum cofactor deficiency (MoCD).~   "
147055|NCT01641627|"~     Confinement to bed, which occurs in many pathological situations, induces a muscle atrophy~     and a loss of muscle strength. Muscle atrophy is associated to impaired performance in motor~     tasks, such as posture and locomotion, and is therefore a major cause of loss of autonomy. It~     requires a stay in follow-up and rehabilitation service, and thus lengthens the duration of~     hospitalisation.~      Data underline the importance of afferent input integrity in the maintenance of muscle~     characteristics and postural control, and suggest that countermeasure programs based on the~     stimulation of proprioceptive inputs could be efficient to prevent muscle atrophy and falls.~     In particular, fundamental studies performed in rodents by the investigators laboratory have~     demonstrated that the adverse structural and functional adaptations which occur during muscle~     deconditioning can be counteracted through adequate physiological stimuli such as activation~     of proprioceptors. Based on this scientific expertise, the investigators aim is thus to~     prevent muscle atrophy and its functional consequences on posture and locomotion, following a~     surgical intervention in humans .~      The investigators will develop a device allowing stimulation of foot and ankle~     proprioceptors. In order to facilitate the evaluation of its efficiency, the device will be~     tested on a selected population confined to bed during a post-operative period (knee~     replacement). It efficiency will be evaluated by means of three parameters: muscle force of~     ankle plantar flexor, muscle volume of lower limb muscles, functional outcome (gait and~     balance analysis).~      The technique developed in the present project could bring benefits to patients confined to~     bed, or in elderly. Preventing or retarding development of muscle atrophy will beneficiate to~     health and quality of life of these patients. In addition, this device might allow to~     consider therapeutic strategies for prevention of atrophy in neuromuscular pathologies.~   "
147056|NCT01641614|"~     The purpose of this study is to evaluate the immediately clinic and ultramicroscopic~     myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested~     heart versus on-pump empty beating heart surgical techniques.~   "
147057|NCT01641601|"~     This is a randomized study evaluating the impact of pre-hospital cervical ripening with a~     transcervical Foley balloon before labor induction in full-term pregnancies on the length of~     inpatient labor induction and maternal satisfaction with the labor induction process. The~     investigators hypothesize that women who receive pre-hospital cervical ripening will have a~     shorter duration of inpatient labor induction as compared to women without pre-hospital~     cervical ripening.~   "
147058|NCT01641588|"~     The aim of this trial has been to explore the effects of self-positioning on cognitive~     performance in the work environment using a standardized cognitive test battery to evaluate~     executive function under two conditions: sitting and standing.~   "
147059|NCT01641575|"~     The purpose of the first part of the study is to evaluate the safety, tolerability, and~     pharmacokinetics of ascending doses of gemcitabine elaidate in combination with cisplatin~     given to patients with advanced solid tumors, and to select a dose for further evaluation in~     the second part of the study.~      The purpose of the second part of the study is to determine the safety, tolerability, and~     exploratory clinical activity of gemcitabine elaidate in combination with cisplatin given to~     patients with Stage IIIb/IV non-small-cell lung cancer (NSCLC).~   "
147060|NCT01641562|"~     Breast cancer represents the most frequent form of neoplasia in women worldwide, being~     responsible of 1.6% of annual deaths. Therefore, it is a major public health issue and~     research in this field should be a priority. Taxanes, such as paclitaxel and docetaxel, are~     extremely powerful antineoplastic drugs, which alone or in association to anthracyclines,~     increase survival and lower the recurrence rate of cancer, but their use is limited by~     cardiotoxicity. Cardiotoxicity can appear early or late after therapy, and may vary from~     subclinical myocardial dysfunction to irreversible heart failure. Currently, cardiac~     dysfunction induced by taxanes is diagnosed through classical echocardiographic parameters.~     However, these cannot detect subtle, early changes of cardiac structure and function.~     Consequently, description of new parameters, which could detect cardiac dysfunction in an~     early stage, becomes essential for detecting the group of patients at risk for irreversible~     heart failure. The objectives of the investigators project, in patients with breast cancer~     treated with taxanes, are to investigate their mechanisms which lead to cardiac dysfunction,~     to describe new parameters for the early diagnosis of cardiotoxicity, and to define~     predictive models for cardiotoxicity. Meanwhile, project will publish the results in~     prestigious journals, leading to an increase of the visibility of Romanian research~     internationally.~   "
147061|NCT01641549|"~     Malfunction of mechanical heart valves due to clot formation is a potentially devastating~     complication. It often results in heart failure, death or stroke. This condition occurs~     frequently in patients with mechanical valves in developing countries because they are unable~     to monitor and adjust the dose of blood thinning medications. The best treatment modality for~     the treatment of patients with this condition is not known. There is no reliable data from~     clinical trials to guide treatment and there are no firm guidelines. Treatment with~     clot-busting drugs is most commonly used because these drugs (e.g., streptokinase) are~     readily available, cheap, and easy to use. However, this treatment is associated with high~     rates of treatment-related side-effects (death, life-threatening bleeding and stroke).~     Moreover, some recent studies suggest that clot-busting drugs may not be as efficacious in~     restoring valve function, as previously believed. Emergency surgery is less often used~     because it is more expensive and the required facilities and manpower are not available at~     all times at all places. But there is evidence to suggest that surgery results in better~     success rates with a lower risk of bleeding and stroke. Well-designed prospective randomised~     trials (the gold-standard for reliable evidence) comparing the efficacy, safety and~     cost-effectiveness of the two modalities, are needed to help doctors in developing countries~     make informed decisions when treating patients with clotted mechanical heart valves. The~     investigators propose to perform a randomised controlled trial comparing emergency surgery~     with treatment with clot-busting agents in patients with clotted mechanical valves. The study~     will be conducted over 4 years at a single, university hospital in a developing country. This~     study will determine how often patients who are treated with surgery will be discharged from~     hospital, with completely restored valve function, without having suffered a stroke or~     life-threatening bleeding, when compared to those who received clot-busting drugs. The~     investigators will also find out which of the treatments is safe and cost-effective.~   "
147062|NCT01641536|"~     This study is an open label, dose escalation study using the classical 3+3 design to~     determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA~     therapeutic vaccine administered by Electroporation in combination with Entecavir in chronic~     hepatitis B patients.~   "
147074|NCT01641380|"~     While there have been major declines in teenage pregnancy around the country, Baltimore,~     Maryland has continued to experience increases over the last several years. Access and~     adherence to contraception has been found to be a major contributor to declines in teen~     pregnancy worldwide. The aim of this proof of concept pilot project is to determine the~     feasibility and acceptability of a text messaging reminder system for communicating with~     urban adolescents using Depo-Provera for long-acting contraception. We will randomize urban~     adolescent girls who have elected Depo-Provera for ongoing contraception to receive either~     standard counseling and clinic appointment reminders or a text messaging (DepoTEXT) follow-up~     intervention. Participants in the DepoTEXT intervention will receive reminders for clinic~     visits and encouraging messages each month for STI prevention. The primary outcomes being~     measured are 1) delivery of text messages 2) preliminary effectiveness for improving~     adherence 3) patient satisfaction with the text messaging program.~   "
147063|NCT01641523|"~     Multicenter, prospective, comparative, observational study with regular follow-up visits.~      The project's aim is long-term follow-up of patients affected by large and complex~     craniolacuniae treated, in standard clinical practice, with CustomBone Service™ Cranial~     (porous bio-mimetic hydroxyapatite custom-made medical device for cranioplasty), autologous~     bone or polymethilmethacrylate customized prosthesis and to compare the clinical outcome and~     safety among the three treatments.~      Elegibility to each treatment will respect the standard clinical practice. Each investigator~     will respect his own hospital criteria for cranial reconstruction.~      Each centre's agreement to participate the study is totally voluntary.~      The study sample size has not been defined on statistical criteria: the study population was~     set at 100 consecutive patients treated with cranioplasty reconstruction with one of the~     three foreseen group.~      Each investigator will not be allowed to enrol more then 20 patients to avoid an enrolment~     imbalance between centres involved.~      Primary study end-points are: evaluation of adverse event incidence after surgical treatment.~      Secondary end-points are: quality of life improvement, evaluation of bone continuity~     restoration evaluated by CT scan analysis, neurological improvement.~   "
147064|NCT01641510|"~     The investigators hypothesize that reduced loading dose of prasugrel followed by reduced~     maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism~     undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24~     hours and 30 days later which is associated with major adverse cardiovascular events.~   "
147065|NCT01641497|"~     Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years~     with a endometrial cancer.~   "
147066|NCT01641484|"~     Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate~     is inexplicably close to 30%. However, important volume of those tumors and their hypoxia~     degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.~      Persistence of tumor hypoxia could be a predictive factor of local control~   "
147067|NCT01641471|"~     Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total~     Knee Arrhtoplasty (TKA)~   "
147068|NCT01641458|"~     The fluoropyrimidines 5-fluorouracil (5FU) and capecitabine (Cp) are among the most commonly~     used anticancer drugs. Still, there is much controversy about the correct dosing, and the~     fact that a minority of patients experience severe, sometimes even lethal toxicity following~     treatment. One important factor predisposing patients to severe toxicity is deficiency in the~     5FU-catabolic enzyme dihydropyrimidine dehydrogenase (DPD). Our group identified 4 DPD risk~     alleles in over 300 Swiss cancer patients, that resulted in a 8-times increased risk of~     experiencing severe toxicity from 5FU or Cp. In patients receiving 5FU as a continuous~     infusion, there are accumulating data that keeping the AUC of 5FU between 20-30 mg*h/L is~     beneficial in terms of treatment toxicity and activity. In this study, patients carrying at~     least 1/4 DPD risk alleles will receive a 50% dose reduction of either 5FU or Cp, with the~     potential of later dose increases in the abscence of severe toxicity. Additionally, patients~     receiving i.v. 5FU will undergo therapeutic drug monitoring at the end of the 2-day~     continuous infusion, with subsequent dose adaptations to target a 5FU AUC of 20-30 mg*h/L.~     The primary study objective is to reduce the incidence of severe treatment-related toxicity~     from 13% (in historical controls) to 5% in study patients.~   "
147069|NCT01641445|"~     This study will help to determine whether the medication, topiramate, reduces alcohol use~     among adolescents with alcohol dependence. It will also help answer the question, How does~     topiramate reduce drinking in teenagers? Understanding how topiramate may reduce drinking in~     adolescents would allow for a more targeted pharmacotherapeutic approach to treatment and~     help to identify additional medications that may hold promise for improving treatment~     outcomes for youth.~   "
147070|NCT01641432|"~     Problems with attention are a common and debilitating consequence of brain injury. Studies~     show that poor attention is the number one predictor of poor cognitive functioning one year~     post-injury. This is due to the fact that attention is a necessary component of more complex~     cognitive functions such as learning & memory, multi-tasking and problem solving. In many~     cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect~     syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the~     brain is plastic and remodeled throughout life by learning and experience, enabling the~     strengthening of cognitive skills or abilities. The investigators own research has shown that~     brief, daily computerized cognitive training that is sufficiently challenging, goal-directed~     and adaptive enables intact brain structures to restore balance in attention and compensate~     for disruptions in cognitive functioning.~   "
147071|NCT01641419|"~     The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the~     duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle~     surgery. The investigators also want to find out if there is a difference between 4 and 8 mg~     dose of dexamethasone.~   "
147072|NCT01641406|"~     The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast~     carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the~     utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype~     test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the clinical~     anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients. To~     evaluate the prognostic factors associated associated with pathological response as measured~     by the residual cancer burden tool.~   "
147073|NCT01641393|"~     The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as~     compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with~     Cystic Fibrosis in subjects 12 years of age and older.~   "
147075|NCT01641367|"~     The study was done to:~        -  test a strategy of using a resistance test to choose anti-HIV drugs~        -  see how well combinations of new anti-HIV drugs work to lower HIV infection~        -  see if taking new anti-HIV drugs together is safe and tolerable~        -  see if text messages improve people's anti-HIV drug-taking behavior (only at sites~          participating in the adherence study)~        -  in people taking certain combinations of anti-HIV drugs with an anti-TB drug, compare~          how these drugs act in the body~        -  to see how people do after they stop having frequent clinic visits as part of a research~          study~   "
147076|NCT01641354|"~     Knock knees or genu valgus necessitates in some children corrective surgery with partial~     closure of the growth plate at level of the knee.~   "
147077|NCT01641341|"~     Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced~     randomization and a cross-over to active treatment for placebo treated individuals who do not~     respond to the placebo treatment. Data collected will help determine the feasibility of the~     study design in primary care offices. Patient outcome data will provide a more precise~     estimate of power for a larger, classic randomized trial to determine if such a study can be~     reasonably undertaken within primary care practices.~      Aims: The aims of this pilot study are to: 1) Evaluate how well Genova Diagnostics (GDx) IBS~     tests can be integrated into primary care, 2) examine the effects of the Genova Diagnostics~     (GDx) test on treatment, and 3) observe and track patients' health, quality of life and~     clinical outcomes related to IBS during the study period.~   "
147078|NCT01641328|"~     Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually~     among older adults, in which a person notices a decline in attention or memory, and performs~     worse than normal on cognitive tests of such. People with MCI are more likely to develop~     Alzheimer's disease or related dementia than others their same age, and so MCI is thought of~     as an early warning sign of progressive cognitive decline.~      While some forms of MCI may be brought about by purely genetic causes, other cases may be due~     to a withdrawal of cognitive engagement with the world. In these cases, a rigorous program of~     cognitive training may be beneficial, halting or reversing symptom progression.~      The current study will evaluate a multifaceted cognitive activation program on older adults~     with MCI. This group program is intensive, running for 10 weeks, 3 times per week, for a~     total of 100 hours of training. Training consists of meditation exercises for broad attention~     activation, Tai Chi exercises to integrate cognition with body awareness, and cognitive~     training through computerized attention, memory, and problem solving exercise.~      Subjective impressions and objective measures of cognitive ability will be measured before~     and after the intervention. The investigators will also examine effects on mood and levels of~     daily function. Results will be compared to a waitlisted control group. The control group~     will subsequently be entered into a home-based version of the program for 10 weeks, with~     assessment before and after training, to look at the importance of the group meeting dynamic~     in promoting cognitive change.~   "
147079|NCT01641315|"~     Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to~     be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen~     with rabies immunoglobulin have never been studied in the aspect that the immunity level~     would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This~     study would access this subject.~   "
147080|NCT01641302|"~     The steep Trendelenburg position and pneumoperitoneum during laparoscopic surgery have the~     potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed~     that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with~     signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by~     ultrasonographic measurement of ONSD during laparoscopic surgery.~   "
147081|NCT01641289|"~     Blackwater fever, characterized by intravascular haemolysis and hemoglobinuria, is an~     important cause of renal impairment and mortality in severe malaria caused by Plasmodium~     falciparum. The largest malaria clinical trials report blackwater incidences of 5-7% in Asian~     adults and 4% in African children with severe malaria treated with artesunate or quinine. The~     prevalence of blackwater fever in Chittagong, Bangladesh is 15% with associated rates of~     renal failure and mortality of 42.9% and 14.2% respectively.~      The fundamental characteristic of blackwater fever is the presence of intravascular hemolysis~     of both infected and uninfected erythrocytes and release of free haemoglobin. The cytotoxic~     free haemoglobin present can cause severe oxidative damage as a result of haem redox cycling~     yielding ferric and ferryl heme, which generate radical species that induce lipid~     peroxidation and subsequent production of F2-isoprostanes (F2-IsoPs). Evidence suggests that~     F2-IsoPs generated by the hemoprotein-catalyzed oxidation of lipids are responsible for the~     oxidative damage and vasoconstriction associated with renal injury in haemolytic disorders~     and rhabdomyolysis.~      A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol is a~     potent inhibitor of hemoprotein-catalyzed lipid peroxidation by reducing ferryl heme to its~     less toxic ferric state and quenching globin radicals. In a recent proof of concept trial,~     paracetamol at therapeutic levels was shown to significantly decrease oxidant kidney injury,~     improve renal function and reduce renal damage by inhibiting the hemoprotein-catalyzed lipid~     peroxidation in a rat model of rhabdomyolysis-induced renal injury. Since adults with severe~     malaria demonstrate increased concentrations of cell-free haemoglobin, and urinary F2-IsoPs,~     the investigators hypothesize that this novel inhibitory mechanism of paracetamol may provide~     renal protection in this population by reducing the hemoprotein-induced lipid peroxidation.~     As there is currently no consensus that exists concerning adequate medical treatment for~     blackwater fever, the potential application of this safe and extensively used drug would be~     of great benefit.~   "
147082|NCT01641276|"~     The propose of this study is to identification of a group of specific amplitude-modulated~     frequencies of low intensity electromagnetic fields that is associated with biofeedback upon~     exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma.~   "
147083|NCT01641263|"~     The objective of this study is to evaluate the ability of a behavioral intervention,~     cognitive behavioral therapy for sleep quality (CBT-SQ) to reduce sleep complaints,~     depression recurrence, and cellular and genomic markers of inflammation in older adults with~     sleep complaints who have a prior history of depression. The investigators aim to: 1)~     evaluate the effects of CBT-SQ vs. Sleep Seminar (SS) on objective (actigraphy) and~     subjective (sleep diary; questionnaire) measures of sleep symptoms over a two-year follow-up;~     2) determine the effects of CBT-SQ vs. SS on recurrence of depressive symptoms and depression~     episode(s) over a two-year follow-up. The investigators will also secondarily examine the~     effects of CBT-SQ vs. SS on cellular and genomic markers of inflammation over a two-year~     follow-up, and explore whether markers of inflammation and cytokine genes can explain~     variability in the risk of depression recurrence in those older adults receiving CBT-SQ vs.~     SS. The present study is highly significant by being the first study, to the investigators~     knowledge, to focus on the prevention of depression in community dwelling older adults who~     have a history of depression, and by targeting sleep disturbance, a modifiable risk factor to~     prevent depression recurrence.~   "
147084|NCT01641250|"~     This multi-center, open-label study will evaluate the safety, pharmacokinetics,~     pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in~     patients with acute myelogenous leukemia. In Part A, patients will receive multiple~     escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus~     up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time~     on study treatment is until disease progression or unacceptable toxicity occurs.~   "
147085|NCT01641237|"~     The proposed study will evaluate the performance of fluoride delivered from a new dentifrice~     formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by~     testing four dentifrices covering a range of sodium fluoride concentration.~   "
147087|NCT01641211|"~     This is a feasibility study to determine whether the Expanding Networks for Latinos through~     Community Engagement (ENLaCE) can be used to recruit Latino children into a randomized,~     controlled trial (RCT) to improve their asthma medication device technique. Children will be~     recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch~     device technique videos (experimental group; n=50) or a nutrition video (control group, n=50)~     in Spanish or English after a regularly-scheduled medical visit. Children's device technique~     will be assessed before and after the visit. Process evaluation data will also be collected.~     The investigators hypothesize that children in the intervention group will have better device~     technique post-intervention than the control group.~   "
147088|NCT01641198|"~     Between 1992 and 1996, 58 subjects were enrolled in a randomised, short and long term~     superiority single centre prospective clinical trial. Each subject was randomly assigned to~     receive 5 mandibular endosseous implants of 3 types (B, SW, SC). All subjects were aged~     between 25 and 56 years, were in excellent physical and mental health, non smokers, not~     taking any prescribed medication, not suffering from TMJ or facial pain abnormalities and~     were treated with complete removable dental prostheses of both jaws for at least one year.~     All subjects were skeletal class I intermaxillary relationship and had at least 1 cm of bone~     height between the superior and inferior cortical tables as well as at least 6 mm. of~     buccal-lingual bone width in the anterior mandibular region between the mental foramina. All~     subjects had type 2 and/or type 3 mandibular bone quality in this area and specifically~     requested a fixed complete dental prosthesis over the mandibular implants accompanied by a~     conventional complete removable maxillary prosthesis. Standardized radiographs of the osseous~     healing around the abutment-implant interface were taken at 12 months after prostheses~     insertion and are to be taken presently and in future at 15 years or more after prostheses~     insertion using the same standardized protocol and equipment. The 3 implant types, B, SW and~     SC, are approved and commercially available in North America. They are paralleled, screw~     endosseous and are composed of commercially pure titanium. Two of the implant types are~     almost identical in design except that one of the implant types (SW) has an acid etched~     microtextured surface versus the smooth, machined non acid etched surface of the other (B).~     The third implant type (SC) possess a very similar design to the others but its~     smooth-surfaced collar is narrower and longer than the smooth surfaced collars of the B and~     SW implant types which are identical. The SC implant type also has an acid etched~     microtextured surface identical to that of the SW implant.~   "
147089|NCT01641185|"~     The purpose of this study is to evaluate the safety and feasibility of primary~     hypofractionated irradiation of the prostate with carbon ions or protons using the raster~     scan technique.~   "
147090|NCT01641172|"~     Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a~     prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These~     chemosensory changes are distressing for patients and can lead to changes in appetite, food~     choice, and nutrient intake. These changes can result in malnutrition and weight loss.~     Possibly, also unhealthy eating patterns can be developed due to these taste and smell~     changes, given the high prevalence of obesity among survivors of certain cancer types. The~     primary objective is to investigate the nature, prevalence, and duration of taste and smell~     changes in patients with disseminated testicular cancer treated with cisplatin based~     chemotherapy.~   "
147091|NCT01641159|"~     The purpose of this study is to evaluate whether or not buspirone is effective in preventing~     relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to~     enter outpatient treatment upon inpatient/residential discharge.~   "
147092|NCT01641146|"~     HIV continues to spread among Black men who have sex with men (MSM), but few interventions~     target high-risk Black men who have sex with men and women (MSMW). Black MSMW with histories~     of childhood sexual abuse (CSA) may be an especially vulnerable population for: a) high-risk~     sexual behaviors; b) negative psychological sequelae (e.g., depressive or posttraumatic~     stress disorder (PTSD) symptoms); and c) neurobiological abnormalities in cardiovascular,~     neuroendocrine and/or immune systems (e.g., cortisol and norepinephrine), and HIV/AIDS~     progression. The purpose of this study was to test an HIV risk reduction intervention, guided~     by the Social Learning Theory, the Ecological Model, and the concept of allostatic load, a~     composite of the cumulative effects of stress on biological systems including~     psychoneuroimmunologic markers. The investigators tested the 6-session Enhanced Sexual Health~     Intervention for Men (ES-HIM) on 88 non-gay identifying HIV-positive Black MSMW with~     histories of CSA. The outcomes were to reduce high-risk sexual behaviors (i.e., unprotected~     anal and vaginal sex and number of sex partners) and negative psychological symptoms of~     depression and PTSD. Links between these outcomes and biomarkers of stress were also~     explored. Randomization to either the ES-HIM or a health promotion control group occurred~     with study participants assessed at baseline, post, 3- and 6-months.~   "
147093|NCT01641133|"~     The primary aim of this study is to assess the reactogenicity of Synflorix™ vaccine and~     Prevenar 13™ vaccine after primary vaccination at 2 and 4 months of age with either~     Synflorix™ or Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™, respectively. In addition,~     this study aims at assessing the safety, reactogenicity, immunogenicity and antibody~     persistence (approximately 8-11 months following primary vaccination) of the Synflorix™~     vaccine and Prevenar 13™ vaccine after primary vaccination at 2 and 4 months of age with~     either Synflorix™ or Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™, respectively. This~     study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix™~     vaccine when given as a booster dose at 12-15 months of age following primary vaccination at~     2 and 4 months of age with either Synflorix™ vaccine or Prevenar 13™ vaccine or Prevenar 13™~     and Synflorix™, respectively.~   "
147094|NCT01641120|"~     The purpose of this study is to evaluate patients' views when injecting Avonex~     intramuscularly.~   "
147095|NCT01641107|"~     Drug resistance resulting from emergence of Imatinib-resistant BCR-ABL clones is a~     significant problem in Ph positive ALL patients because after a very good initial response to~     one TKI inhibitor, many patients relapse within one year, relapse being almost always~     associated with a BCR-ABL kinase domain point mutation. The patients who relapse after~     treatment with one TKI can be rescued to remission with another TKI, but the second remission~     is usually shorter than the previous one. A more potent TKI inhibitor, and pan-active not~     only on all the BCR-ABL variants (including the second generation TKI resistant T315I~     mutant), but also on others molecular targets can do better. In this context, Ponatinib is a~     novel synthetic orally active tyrosine kinase inhibitor (TKI), specifically developed to~     inhibit BCR-ABL, the fusion protein that is the product of the Philadelphia chromosome (Ph)~     in chronic myeloid leukemia (CML) and in a subset of acute lymphoblastic leukemia (Ph+ ALL).~     It potently inhibits the BCR-ABL protein as well as mutated forms of the protein that arise~     in patients resistant to prior therapies with TKIs. Ponatinib has been demonstrated to~     inhibit all the mutations that have been detected so far, in vitro and in vivo and to~     uniformly suppress the emerge of single-mutant clones in a mutagenesis assay. In the Phase II~     study, 41% of Philadelphia chromosome positive acute lymphoblastic leukemia patients treated~     with Ponatinib achieved major hematologic response, 47% had a major cytogenetic response, 38%~     obtained a complete cytogenetic response, showing that Ponatinib provides significant benefit~     despite previous intolerance or refractoriness to other TKIs. The Phase I trial showed that~     patients with a more recent diagnosis had increased rates of major molecular response: 79%~     for 14 patients with 0 to 5 years since diagnosis vs. 29% for 14 patients with more than 5 to~     9 years since diagnosis (P=0.02) and 27% for 15 patients with more than 9 to 24 years since~     diagnosis (P=0.009). These characteristics support the hypothesis for a role of Ponatinib not~     only in patients resistant to prior TKI therapy but also in untreated ALL Ph+ patients, in~     order to prevent the emergence of resistant caused by the selection of mutated Ph+ clones and~     in order to avoid rapid progression of the disease.~   "
147096|NCT01641094|"~     Chronic hepatitis C infection (HCV) is a disease that affects worldwide about 170 million~     people. The previous standard of care therapy of chronic HCV patients consists of~     pegylated-IFN-α combined with ribavirin, and results in sustained clearance of HCV-RNA in~     only about 50% of the HCV genotype 1 infected patients. Telaprevir, a NS3A-4A inhibitor, has~     previously proven to offer therapeutic options to previous non-responders to the standard of~     care. Although, not all chronic HCV patients benefit from telaprevir and it is still not~     known why certain patients are also non-responsive to this triple therapy. In this study we~     try to understand why certain patients are also non-responsive to telaprevir, how triple~     therapy modulates the responsiveness to IFN-α and what the immunological consequences are of~     treatment with telaprevir, either directly or as a result of telaprevir-induced reduction of~     HCV-RNA levels.~   "
147097|NCT01641081|"~     The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol~     fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to~     moderate asthma.~      This study will include a screening visit followed by a 4 month treatment period.~   "
147098|NCT01641068|"~     The purpose of this study is to examine thinking abilities, mood, and quality of life in~     cancer survivors before and after an 8-week group-based memory and thinking skills workshop.~     Research participants will include people treated for cancer in the past. Researchers would~     like to know if there is a relationship between baseline performance on timed attention and~     memory tasks before receiving memory and thinking skills workshop designed to improve~     cognition, and performance on such tasks after the workshop.~   "
147099|NCT01641055|"~     The purpose of this study is to compare the possible health benefits of intake of proteins~     from salmon, herring, cod and milk on glucose tolerance in overweight and obese adults.~     Overweight and obese subjects often have reduced glucose tolerance, and previous findings~     from a study on cod proteins suggested that glucose tolerance was improved.~   "
147100|NCT01641042|"~     The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of~     the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease~     and compare it to its activity in healthy subjects.~   "
147101|NCT01641029|"~     Pyelonephritis is a serious infection that manifests with fever, back pain, nausea, and~     vomiting. In the U.S., it is estimated that there are 20 cases of pyelonephritis per 10,000~     annually, with the highest incidence in young women. Escherichia coli (E. coli) causes over~     80% of these infections. Over the last two decades, E. coli resistance has emerged to~     commonly prescribed antimicrobials, such as ampicillin and trimethoprim-sulfamethoxazole~     (TMP/SMX). Most recently, resistance to fluoroquinolones and strains producing~     extended-spectrum beta-lactamases (ESBL) have been observed. In order to better understand~     the evolution and current state of antibiotic resistance among E. coli urinary tract isolates~     so as to better inform treatment decisions, the investigators propose to conduct an~     investigation to: a) determine the prevalence of antimicrobial resistance among E. coli~     causing acute pyelonephritis in various patient groups, and specifically healthy~     community-dwellers with uncomplicated infections, b) determine the specific prevalence of~     fluoroquinolone-resistance and ESBL-producing E. coli, and c) determine potential risk~     factors for fluoroquinolone and ESBL-producing E. coli infections.~   "
147102|NCT01641016|"~     The overall aim of the BREATHER trial is to evaluate the role of Short-Cycle Therapy (SCT) in~     the management of HIV-infected young people who have responded well to antiretroviral therapy~     (ART) and to determine whether young people with chronic HIV infection undergoing Short-Cycle~     Therapy of five days on ART and two days off maintain the same level of viral load~     suppression as those on continuous therapy, over 48 weeks.~      To assess the advantages and disadvantages of the strategy, the incidence of toxicities,~     immunological control, resistance mutations, acceptability, quality of life and adherence to~     the randomised strategy will also be compared.~      Importantly, because of insufficient data on short-term viral load rebound after stopping ART~     in this population, the trial will incorporate an initial pilot phase in selected centres, to~     assess the safety of the SCT strategy by evaluating detailed HIV-1 RNA profiles of~     participants on the SCT strategy.~   "
147103|NCT01641003|"~     1. to evaluate insoluble fibrinogen particles (iFP), as a tool for harvesting, growing and~          transferring attachment-dependent cancer stem cells and comparing it to the standard~          method ( coated plate) .~        2. to evaluate whether using iFP for growing CSC can yield better results of isolating and~          enriching CSCs from fresh tumors than other conventional methods~   "
147104|NCT01640990|"~     This study is a single dose evaluation using an open label dose escalating design. Cohort1~     will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion~     over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5~     hours (total dose of 12mcg) and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg).~     Subjects will have continuous cardiac monitoring throughout the dosing period and up to 2~     hours after cessation of the intravenous infusion. PK measurements and measurement of~     erythropoietin and platelet activation will also be done. Samples for PK will be taken at 30~     minute intervals during the infusion of GW328267X up to and including 1 hour after cessation~     of the intravenous infusion. Samples for erythropoietin and platelet aggregation will be~     done.~      Cohort 2 is optional and may be carried out in the event that the dose of GW328267X given in~     Cohort 1 is both well tolerated and subjects do not meet the stopping criteria. The decision~     to proceed to Cohort 2 and the dose level will be made by the GSK Study Team and the~     Investigator based on safety, tolerability and preliminary PK/PD data obtained in Cohort 1.~     It is planned that the maximum total dose given to any subject will not exceed 150mcg. Cohort~     2 will consist of 3 healthy male volunteers and the study procedures for this additional~     Cohort will be the same as that described for Cohort 1.~   "
147105|NCT01640977|"~     The study is a prospective non-concurrent controlled observational evaluation of short-term~     operative results. As such, study sites will capture perioperative (through 6-week~     postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar~     interbody fusion) procedures. After this open experience, these same sites will capture the~     corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF~     variant was performed. The data from both series of cases will be compiled to identify~     similarities and differences between the techniques.~   "
147106|NCT01640964|"~     The main purpose of this exploratory study was to investigate the effect of serelaxin~     (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis~     and portal hypertension. Measurements were acquired non-invasively using magnetic resonance~     angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein~     during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study~     part B), to determine the acute haemodynamic response to serelaxin (RLX030).~   "
147107|NCT01640951|"~     CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307~     (core studies). This extension study planned to collect up to four years of long-term safety,~     tolerability and efficacy data of secukinumab in both the fixed interval regimen and the~     retreatment at start of relapse regimen. All subjects who completed the full study treatment~     period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to~     participate in this extension study. In this extension study, the prefilled syringe (PFS)~     liquid formulation of secukinumab was used.~   "
147108|NCT01640925|"~     This prospective, randomized, controlled trial will compare the incidence of nosocomial~     infections (composite of primary bloodstream infections, catheter-associated urinary tract~     infections, ventilator-associated pneumonia, and surgical site infections) that occur in~     intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who~     receive standard bathing (soap and water or non-medicated cloths).~   "
147109|NCT01640912|"~     The primary purpose of this study is to evaluate the safety and tolerability of a single~     intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that~     will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo~     on scarring at these incision sites will be evaluated visually and histologically.~   "
147110|NCT01640899|"~     The aims of this study were to evaluate the effects of insoles on pain, daily activities and~     physical activity level, and to investigate the relation between satisfaction with the~     insoles and their actual use in individuals with LE pain.~   "
147111|NCT01640886|"~     In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and~     methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's~     bacteriophage-based diagnostic platform.~   "
147112|NCT01640873|"~     This study will assess the initial safety, tolerability, pharmacokinetics, and~     pharmacodynamics of MK-8655, after single and multiple daily oral administrations to~     participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting~     plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.~   "
147113|NCT01640860|"~     This study is designed to determined the feasibility and safety in advanced esophageal cancer~     treated with docetaxel and cisplatin cocurrent chemoradiotherapy. The primary end points were~     clinical best response and response rate and secondary endpoints were progression free~     survival and overall survival.~   "
147114|NCT01640847|"~     This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in~     combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for~     patients with painful bone metastases.~   "
147115|NCT01640834|"~     This study involves taking a single dose of 100 mg or 300 mg LY2409021 or placebo (an~     inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug~     will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes~     a 7 day hospitalization period at the clinical research unit (CRU) and will involve screening~     within 30 days of the start of the study as well as telephone consultations within 5 days~     after discharge from the CRU.~   "
147116|NCT01640821|"~     The Québec government launched in October 2006 an action plan (PAG) to reduce the prevalence~     of overweight and obesity among young people and adults by 2012. One of the five priorities~     of the PAG is to improve health services for individuals with weight-related issues. The~     development and implementation of sustainable weight-control strategies however remains a~     challenge, since weight loss is often regained by the majority of individuals over time.~     Health-At-Every-Size (HAES) interventions, which are mainly focusing on health rather that~     weight, have been proposed as an interesting alternative for individuals, mainly women, who~     are struggling with weight-related issues. Based on the HAES, Choisir de maigrir? (CdM?)~     program has been clearly identified by the PAG as one of the actions for improving health~     services and Quebec's government has already started a massive dissemination of the CdM?~     program in CSSS of Québec. In that context, it becomes imperative to rapidly assess the~     effectiveness and readiness of the program for a broad dissemination. The present research~     proposal falls directly within the scope of the PAG recommendation and the investigators~     general objective is to develop a population-based understanding of the effectiveness of the~     CdM? program in Quebec's CSSS by documenting the effects of the program on women's health in~     a natural setting.~   "
147117|NCT01640808|"~     The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in~     inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the~     disease, with the recurrence-free survival as the primary endpoint, in a multi-center,~     randomized, double-blind, placebo-controlled, parallel-group comparison study.~   "
147118|NCT01640782|"~     Open label, randomised, multicenter, superiority study for efficacy. Patients with~     histologically proven adenocarcinoma of the stomach or gastroesophageal junction without~     gross or microscopic evidence of residual disease after surgery with curative intent and~     fulfilling all the inclusion/exclusion criteria are eligible for this study.~   "
147119|NCT01640769|"~     Magnetic Resonance Image guided delivery of Left and Right Ventricular Leads to optimal~     myocardial targets will result in improved clinical response to CRT using Left Ventricular~     remodeling criteria.~   "
147120|NCT01640756|"~     To establish the safety and performance of the AqueSys Microfistula Implant in eyes with~     refractory glaucoma.~   "
147121|NCT01640743|"~     The objective of the study will be to evaluate the effect of different therapeutic~     immunosuppressive strategies currently employed in common clinical practice on regulatory T~     lymphocytes and to verify the hypothesis that the association of thymoglobulins - mTOR~     inhibitors - small doses of Tacrolimus not only represents a safe anti-rejection therapy but~     it can also lead to mid-term formation of a high amount of regulatory T cells and,~     consequently, a high grade of tolerance.~   "
147124|NCT01640704|"~     Numerous studies have examined potential causes for the racial differences in HTN prevalence~     and severity including baseline insulin levels, sympathetic nervous activity, intracellular~     calcium levels and intracellular sodium levels.[21-23] However, to our knowledge, there have~     been no studies examining the relationship of physician adherence to JNC guidelines to racial~     disparities in outcomes from HTN; nor have there been published studies examining the use of~     interventions such as computerized decision support tools or case-management to improve JNC~     adherence with the goal of reducing racial differences in blood pressure control. The aims of~     this study are: 1) To determine if physician's prescribing practices for HTN medications~     adhere to JNC guidelines for drug therapy.~      2) To determine if there are variations in adherence to JNC guidelines based on patient race.~      3) To determine if adherence to JNC guidelines improves blood pressure control. 4) To~     determine if the use of computerized medical reminders improves adherence to JNC guidelines.~   "
147125|NCT01640691|"~     The objectives of this single arm study are to evaluate the immune response and safety~     profiles of two injections of an inactivated whole-virion vaccine containing aluminum~     hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.~   "
147126|NCT01640678|"~     Autologous epidermal cell suspension grafting is an effective method of surgical treatment in~     vitiligo, which is suitable for treating larger areas with better cosmetic results as~     compared to other grafting methods. The ReCell Autologous Cell Harvesting Device (Avita~     Medical Europe Limited, Cambridge, UK) is an autologous cell harvesting device which,~     compared to other forms of autologous epidermal cell suspension grafting, is easier in use~     showing similar results. Furthermore, the ReCell device needs no laboratory facilities.~     Therefore, it is promising for patients with large vitiligo and piebaldism lesions.~      Objectives: Primary: to asses the efficacy and safety of autologous epidermal cell suspension~     grafting with the ReCell device after CO2 laser abrasion compared to CO2 laser abrasion alone~     and no treatment, in patients with piebaldism and stable vitiligo. Secondary: to assess the~     practical aspects and patients satisfaction of autologous epidermal cell suspension grafting~     with the ReCell device.~      Study design: Prospective observer blinded randomized controlled pilot study. Study~     population: 10 patients ≥ 18 years with stable segmental vitiligo or piebaldism who are under~     treatment at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical~     Centre University of Amsterdam.~      Methods: Three depigmented regions on the trunk or proximal extremities will be randomly~     allocated to; CO2 laser abrasion + ReCell autologous cell suspension grafting, or CO2 laser~     abrasion, or no treatment. After the transplantation, UV-treatment according to the standard~     treatment protocol of the NIPD will be started on all sites and continued for 3 months. Three~     and six months after grafting, the percentage of repigmentation of the lesions will be~     assessed.~   "
147127|NCT01640665|"~     The purpose of this study is to find the maximum tolerated dose of the combination of two~     drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug~     which is used to treat certain cancers. The drug Capecitabine is approved to treat patients~     with advanced breast cancer as well as early stage colon cancer.~   "
147128|NCT01640652|"~     In this study the investigators are testing a new vaccine against Neisseria meningitidis, the~     leading infective cause of childhood death in the UK. This bug (also known as meningococcus)~     can infect the lining of the brain (meningitis) or the blood stream (septicaemia) and can~     affect all ages, but especially children, adolescents and young adults.~      The bug is classified into different groups based on its outer capsule (or shell), and this~     study will test a new vaccine to protect against group B meningococcus (MenB) disease, which~     is the most common type in the UK.~      Vaccines are given to prepare the immune system to fight an infection. Vaccines work by~     stimulating the immune system to produce specialised proteins (called antibodies) and white~     blood cells designed to kill the bug later in life if needed.~      Vaccines against other types of meningococcus have been developed and saved many lives.~     However MenB is different because its outer capsule does not stimulate the immune system very~     effectively. There is therefore no broadly effective vaccine against MenB disease.~   "
147129|NCT01640639|"~     Several studies have shown that inflammation and matrix degradation have pathogenic effects~     on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the~     matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling~     process.~      The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory~     and antioncogenic properties that could be of benefit in case of congestive heart failure~     (CHF).~      Previous, small investigations have shown an improvement in left ventricular ejection~     fraction and a favorable cardiac remodeling during thalidomide therapy.~   "
147130|NCT01640626|"~     There is a sever lack in application of health education intervention for Soil Transmitted~     Disease (STH) in rural communities and in school children among Orang Asli in Pahang in~     Malaysia, and also there is a lack of information on the effect of different health education~     aspects on STH control in Malaysia, so the investigators think that introducing such new~     national educational package and for the first time in Malaysian's school will help children~     to make some behavior changes specially for the school children aiming to use these children~     as an educator agents to their families and preschool brothers and sisters, to build a base~     for this issue and to reduce STH intensity in these rural areas, which in turn will determine~     the best approach to health education intervention to be applied to other rural areas in~     Malaysia.~   "
147131|NCT01640613|"~     The aim of this study is to describe technique, efficiency, safety and satisfaction of~     ultrasound guided intermediate cervical plexus block for carotid endarterectomy.~      The investigators present a simple approach for carotid regional anaesthesia by an anterior~     way that has not been published yet.~   "
147132|NCT01640600|"~     The purpose of this project is to conduct a follow-up study with women that had participated~     in the Yale Pink and Blue Study of depression in pregnancy and birth outcomes. The Yale Pink~     and Blue Kids Study is a follow-up study with the mothers and also with the children they~     were pregnant with in Yale Pink and Blue. These children are now between the ages of 4 and 8~     years old, which is a perfect time to look at developmental outcomes in children. This study~     will look at children with exposure to nicotine or antidepressants during pregnancy, as well~     as children who were not exposed. The investigators hypothesis is that children who were~     exposed to either nicotine or antidepressants in pregnancy will have poorer developmental~     outcomes than children who were not exposed. The investigators are also interested in~     determining whether nicotine exposure or antidepressant exposure results in poorer outcomes.~      The investigators specific aims are:~        1. To determine whether pre-school and school aged offspring exposed to maternal cigarette~          smoking or antidepressants during pregnancy are more likely to have social-emotional~          problems compared to children who were not exposed to cigarettes or antidepressants~          during pregnancy.~        2. To determine whether pre-school and school aged children who were exposed to prenatal~          maternal cigarette smoking or antidepressants during pregnancy display cognitive~          impairments as compared to children who were not exposed to either prenatal maternal~          cigarette smoking or antidepressants.~        3. To determine if pre-school and school aged children who were exposed to maternal~          prenatal cigarette smoking or antidepressants display impaired motor development as~          compared to children who were not exposed to maternal cigarette smoking or~          antidepressants in pregnancy.~   "
147133|NCT01640587|"~     In camps for displaced persons located along the Thai-Myanmar border, mefloquine and~     artesunate combination therapy has been used since 1992. In vivo efficacy of a 3 day regimen~     of mefloquine + artesunate (MAS3) has been monitored regularly since its introduction in~     1992. In 2009 Carrara et al summarised the in vivo PCR-adjusted cure rates at Day 42 and Day~     63 in patients treated with MAS3 between 1995 and 2005, as well as the in-vitro parasite~     susceptibility to MAS3 during that same period, and the changes in pfmdr1 copy numbers.The~     proportion of patients with parasitaemia persisting on day-2 increased significantly from~     4.5% before 2001 to 21.9% after 2002 (p<0.001). Delayed parasite clearance was associated~     with increased risk of developing gametocytaemia (AOR = 2.29; 95% CI, 2.00-2.69, p = 0.002).~     MAS3 efficacy declined slightly but significantly (Hazards ratio 1.13; 95% CI, 1.07-1.19,~     p<0.001), although efficacy in 2007 remained well within acceptable limits: 96.5% (95% CI,~     91.0-98.7). The proportion of infections caused by parasites with increased pfmdr1 copy~     number rose from 30% (12/40) in 1996 to 53% (24/45) in 2006 (p = 0.012, test for trend).~      Evidence of reduced susceptibility to artemisinins in Western Cambodia was first reported in~     January 2007. Artemisinin resistance was manifest by a marked slowing of parasite clearance.~     A more recent analysis of parasite clearance data collected prospectively in patients with~     uncomplicated hyperparasitaemic malaria has shown a progressive decline in parasite clearance~     rates over the last decade suggesting a decline following the same trajectory as in Western~     Cambodia but with a time lag of a few years.~      Surveillance data collected in 2011 have shown a dramatic and worrying decline in efficacy of~     MAS3, albeit in a small number of patients. This decline in efficacy of mefloquine +~     artesunate is likely to be attributable to reduced parasite susceptibility to mefloquine. The~     other fixed dose combinations available dihydroartemisinin-piperaquine (DP) is the best~     option to replace mefloquine-artesunate since it is thought that it remains effective in the~     presence of high pfmdr1 copy numbers. In addition DP is administered once daily and needs no~     special dietary modification to ensure adequate absorption.~      In this study it is hypothesised that efficacy of DP (estimated to be 95%) will be~     significantly higher than that of MAS3 (estimated to be 65%), therefore the investigators~     propose to conduct a randomised controlled trial between DP and MAS3 for the treatment of~     P.falciparum.~   "
147134|NCT01640574|"~     In Southeast Asia, Plasmodium vivax (Pv) infection reaches 50-80% and bears a greater burden~     of disease than Plasmodium falciparum (Pf). As control over Pf improves, Pv will assume~     increasingly larger percentages of malaria prevalence. The chronicity of Pv, due to the~     latent liver stage (hypnozoite) not eradicated by chloroquine, causes recurring disability~     and compounds the economic burden of those with symptomatic disease. The only widely~     available treatment for hypnozoites is primaquine, which, because of challenges with~     tolerability, safety in G6PD deficient persons, and compliance, is not commonly prescribed~     for the treatment of Pv. Currently, chloroquine is used for the treatment of the blood stages~     of Pv, however, there are concerns about increasing parasite resistance. Alternative~     treatments, such as artesunate, should be considered in the future of the treatment of blood~     stage Pv. The use of primaquine in the treatment of hypnozoites (radical cure) should be~     emphasized so that transmission of Pv can be controlled.~      This study aims to determine the optimal primaquine regimen for radical cure of Plasmodium~     vivax. Chloroquine is currently the standard of treatment for Plasmodium vivax. Chloroquine~     may have synergistic effects when used with primaquine and due to its long half-life may~     delay the first relapse of vivax malaria. In contrast, artesunate does not have documented~     interactions with primaquine and has a very short half-life, thus, presumably will have no~     impact on first relapse. Combining primaquine with these two anti-malarials may lead to an~     alternative regimen for Pv infection and changing the primaquine dosing regimen may lead to a~     more practical and efficacious therapy.~   "
147135|NCT01640561|"~     Early childhood (up to age 5 yrs) is a period of dramatic change in the cognitive, emotional,~     social, and behavioral domains; children continuously progress by observing and interacting~     with the world around them. In the face of economic instability and nutritional, medical and~     educational deprivation, HIV-affected very young children are the most vulnerable HIV~     subgroup globally because their families are often the most vulnerable, with little margin~     for sustaining a favorable developmental milieu for the child. Through strategic caregiver~     interventions during this sensitive period of child neurodevelopment, our study findings have~     the potential for positively re-directing the developmental trajectories of tens of millions~     of HIV-affected children globally.~   "
147136|NCT01640548|"~     This non-interventional, retrospective, cross sectional chart review study will evaluate the~     management of rheumatoid arthritis patients with a biologic in monotherapy. Data from~     eligible patients will be collected from the patient's last visit on the prior rheumatoid~     arthritis treatment and from the most recent visit for the biological monotherapy.~   "
147137|NCT01640535|"~     The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast~     Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and~     Montelukast monotherapies and to compare the safety and tolerability of Concomitant~     Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and~     Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.~   "
147138|NCT01640522|"~     The purpose of this study is to test the efficacy of a collaborative care intervention to~     manage cancer-related symptoms and improve health related quality of life in patients~     diagnosed with hepatobiliary carcinoma.~   "
147139|NCT01640509|"~     The purpose of this study is to prove the safety and acceptability of treatment with the~     Synchrotron radiation by medium-term medical follow-up of the patients.~   "
147140|NCT01640496|"~     The purpose of this study is to test blood and tissue samples of people with Ulcerative~     Colitis (UC) to see what effects Vitamin D3 may have on the immune system. This research is~     being done because it could lead to the development of new treatment for people with~     Inflammatory Bowel Disease (IBD).~   "
147141|NCT01640483|"~     Post-hoc analysis of psychotherapy outcome data suggest that psychodynamic techniques for~     Major Depressive Disorder are differentially efficacious dependent on personality traits of~     the patient. More specifically, supportive techniques are hypothesized to be more efficacious~     for dependent patients, interpretative techniques to be more efficacious for self-critical~     patients, and mixed supportive/interpretative techniques to be more efficacious for mixed~     dependent/self-critical patients. Moreover, supportive techniques are hypothesized to impact~     on depressive symptoms through increased relational capacities while interpretative~     techniques impact through increased self-understanding.~      These hypotheses are tested in an experimental single case design with three dependent, three~     self-critical and three mixed dependent/self-critical depressive patients. These patients go~     through a time-limited (50 sessions) experimental treatment which exists of a sequence of~     four A phases (control conditions), one B phase (supportive techniques only), one C phase~     (interpretative techniques only), and one BC phase (mixed supportive/interpretative~     techniques).~   "
147142|NCT01640470|"~     Many individuals with mobility limitations, especially those who are older and have more~     severe impairments, use a combination of assistive devices and personal assistance to meet~     their needs. Assistive technology (AT), which includes devices such as wheelchairs, walkers,~     bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social~     participation (basic and instrumental activities of daily living) among these individuals and~     may decrease their dependence on human assistance. Although some research has reported~     beneficial outcomes of AT use, few studies have used controlled experimental designs.~     Furthermore, the results are often difficult to interpret because the AT interventions are~     only vaguely described. Another concern is that many individuals receive help from others,~     but scant attention has been paid to the impact of AT on caregivers. This neglect produces an~     incomplete portrayal of the effect of AT interventions. The proposed study addresses these~     deficiencies by evaluating the effects of a formalized dyadic AT intervention on individuals~     with mobility limitations and on their caregivers. The Assistive Technology Provision,~     Updating and Training (ATPUT)intervention involves a detailed in-home assessment of~     participants' current AT; the negotiation and implementation of a personal AT plan with the~     participants and their caregivers; and the provision of AT devices, non-structural home~     modifications, and device training.~      Objectives:~        1. To determine the efficacy of the Assistive Technology Provision, Updating and Training~          intervention for assistance users and for their caregivers.~        2. To explore how the intervention is experienced by these individuals and to help explain~          the study findings.~      General Hypotheses:~      The investigators anticipate this intervention will increase the daily activities and social~     participation of individuals with mobility limitations; decrease the psychological and~     physical demands on caregivers; and reduce the amount of caregiving required.~      Methodologies:~      This research will use a combination of quantitative and qualitative methods. The~     quantitative portion will be an experimental, single-blinded study in which the investigators~     randomly assign participants to either the ATPUT or a customary care group.~   "
147143|NCT01640457|"~     NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and~     efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy,~     and of the adjacent degenerated disc, if present. The objective of this clinical study is to~     provide basis for a confirmatory study design (endpoints, methodologies) (Phase II), and to~     develop a safety profile (Phase I). This study further aims at developing and validating~     known and new biologic markers for the quality and clinical efficacy of the product as~     requested in the context of identity, purity and potency characteristics of the~     medicinal/investigational product.~   "
147144|NCT01640444|"~     The purpose of the study is to explore the influence of BRAF and PIK3K status on the efficacy~     of FOLFIRI plus Bevacizumab or Cetuximab, as first line therapy of patients with RAS~     wild-type metastatic colorectal carcinoma and < 3 circulating tumor cells~   "
147145|NCT01640431|"~     The purpose of this study was to compare the efficacy of method Lumbar Segmental~     Stabilization and transcutaneous electrical nerve stimulation (TENS) on pain, functional~     disability and ability to activate the transversus abdominis (TrA) of individuals with~     chronic back pain caused by disc herniation.~   "
147146|NCT01640418|"~     In this study we would like to find a way to prevent sacral pressure ulcers in high-risk~     patients by the use of a Mepilex sacral dressing. The research question we would like to~     answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the~     prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk~     hospitalized patients?~   "
147147|NCT01640405|"~     The purpose of the study is to evaluate FOLFOX + bevacizumab versus FOLFOXIRI + bevacizumab~     as first line treatment of patients with metastatic colorectal cancer not previously treated~     and with three or more circulating tumoral cells.~   "
147148|NCT01640392|"~     The purpose of the MyLife MyStyle Evaluation Project is to determine whether the MyLife~     MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old~     African American men who have sex with men (MSM). Specifically, the project will test whether~     participants of the MyLife MyStyle program will report at least a 15% absolute decrease in~     frequency of unprotected anal sex with male partners at three and six months~     post-intervention compared with the wait-list control participants.~   "
147149|NCT01640379|"~     The investigators are enrolling 350 young women 13-21 years old diagnosed with pelvic~     inflammatory disease (PID) in Baltimore and randomize them to receive community health nurse~     (CHN) clinical support using a single post-PID face-to-face clinical evaluation and short~     messaging system communication support during the 30. The investigators hypothesize that~     repackaging the recommended Centers for Disease Control and Prevention (CDC) follow-up visit~     using a technology-enhanced community health nursing intervention (TECH-N) with integration~     of an evidence-based sexually transmitted infection (STI) prevention curriculum will reduce~     rates of short-term repeat infection by improving adherence to PID treatment and reducing~     unprotected intercourse and be more cost-effective compared with outpatient standard of care~     (and hospitalization).~   "
147150|NCT01640366|"~     The purpose of this study is to see if the use of a single-use negative pressure wound~     therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing~     complications following breast reduction surgery and to assess the medium-term aesthetic~     appearance and quality of the resultant scar,compared with standard of care dressings.~   "
147151|NCT01640353|"~     The purpose of this study is to evaluate the use of the iFuse Implant System to treat~     degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal~     separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a~     medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally~     invasive surgical procedure (one that uses a smaller incision and less damage to the skin and~     other tissues than standard surgery). The purpose of implanting the device is to stabilize~     and fuse the SI joint.~   "
147152|NCT01640340|"~     Palonosetron is different from ondansetron because it stays in the body longer and may~     prevent nausea and vomiting for a longer period of time than ondansetron. It is standard~     practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to~     prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these~     combinations are commonly used, they have never been compared to each other. The purpose of~     this study is to record the amount of nausea and vomiting, and the amount of rescue~     medication that is used with these two different anti-emetic regimens~   "
147169|NCT01640106|"~     The primary objective of this study is to obtain preliminary (pilot) data regarding the~     feasibility of using dietary omega-3 supplementation in children with significant delays in~     language skills; a related secondary objective is to compare adherence to a dosage schedule~     of two easy-to-take formulations. A tertiary objective of this study is to collect~     preliminary (pilot) data pre- and post-supplementation to identify potential improvement of~     skills in a specific area of language development.~   "
147153|NCT01640327|"~     This protocol was designed to evaluate the safety, clinical tolerability and immunogenicity~     of the Trivalent Influenza Virus Vaccine (TIVf, purified surface antigen, inactivated, egg~     derived), Northern Hemisphere formulation 2012/2013. The principal aim was to provide safety~     and immunogenicity data, in compliance to current EU Guidelines, with the intent of obtaining~     marketing approval of the vaccine formulation intended for use prior to the next influenza~     season in the Northern Hemisphere.~      The antibody response to each influenza vaccine antigen, was measured by hemagglutination~     inhibition (HI) and single radial hemolysis (SRH) at approximately 21 days postimmunization~     in adult and elderly subjects. The safety and immunogenicity of a single intramuscular (IM)~     injection of the vaccine was evaluated in compliance with the requirements of the current EU~     recommendations for clinical trials related to yearly licensing of influenza vaccines~     (CPMP/BWP/214/96).~   "
147154|NCT01640314|"~     The purpose of this study is to evaluate the safety of a single intramuscular (IM) injection~     of the cell derived subunit trivalent nonadjuvanted influenza vaccine in adult and elderly~     subjects and the antibody response to each influenza vaccine antigen, as measured by~     hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and~     elderly subjects in compliance with the requirements of the current EU recommendations for~     clinical trials related to yearly licensing of influenza vaccines.~   "
147155|NCT01640301|"~     This phase I/II trial studies the side effects of laboratory-treated T cells and to see how~     well they work in treating patients with high-risk acute myeloid leukemia (AML),~     myelodysplastic syndrome (MDS), or chronic myelogenous leukemia (CML) that has returned after~     a period of improvement (relapsed), previously treated with donor stem cell transplant.~     Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune~     system in different ways and stop cancer cells from growing. Placing a gene that has been~     created in the laboratory into a person's T cells may make the body build an immune response~     to kill cancer cells.~   "
147156|NCT01640288|"~     The purpose of this study is to develop and evaluate the usefulness of MRI using inert~     perfluorinated gases mixed with oxygen for regional assessment of pulmonary function. The~     proposed study seeks to determine regional qualitative and quantitative lung function~     information in the context of the clinical trajectory of chronic obstructive pulmonary~     disease (COPD) defined by the cross sectional cohort component. In the case of these~     perfluorinated (PFx)/oxygen mixtures, the availability of multi-liter quantities allows for~     wash-in/wash-out image acquisition and analysis allowing direct measures of gas trapping in a~     manner not easily achieved with any existing modality.~   "
147157|NCT01640275|"~     Previous work in animal models suggests that inhalational anesthetic agents may accelerate~     Alzheimer's disease pathogenesis, but it is unclear to what extent this may happen in humans.~     Here, the investigators propose to measure Alzheimer's disease-related neural markers in the~     cerebrospinal fluid (CSF) of patients exposed to anesthesia while undergoing neurosurgical~     procedures that require lumbar drain placement. Patients will be randomized to either receive~     inhalation anesthesia with isoflurane or intravenous anesthesia with propofol.~      CSF and blood samples will each be collected at the induction of anesthesia, and then again~     ten and twenty-four hours later. CSF samples will be assayed for amyloid beta, tau, and other~     Alzheimer's disease-associated markers; blood samples will be assayed for serum inflammatory~     markers and used for genotyping studies. These studies should clarify the effect of common~     anesthetic agents on Alzheimer's disease related neural markers.~   "
147158|NCT01640262|"~     Clinical staging of prostate cancer in Denmark is determined solely by digital rectal~     examination and sometimes by TRUS, even though the investigators know these examinations are~     inaccurate and have limitations. Since the majority of men diagnosed with prostate cancer~     will die with their disease and not of their disease, and the different treatment-options may~     imply greater side effects, it is important to improve the diagnostic localization and~     staging of the tumour for optimal clinical management and therapy selection.~      The development of modern multiparametric-high-field-magnetic-imaging (mMRI) offers new~     possibilities and approaches in detection, localization and staging of prostate cancer due to~     its high resolution and soft-tissue contrast. mMRI can provide information about the~     morphological, metabolic and cellular changes and characterize tissue- and tumour-~     vascularity and correlate it with tumour aggressiveness. This helps to locate and stage a~     possible tumour and to guide targeted-biopsies towards disease-suspicious areas.~     Internationally published data support the rapidly growing use of multiparametric MRI, as~     being the most sensitive and specific imaging tool for prostate cancer patients.~      While mMRI internationally is a well recognized and accepted method for detection,~     localization and staging of prostate cancer, the use of mMRI in the diagnosis of PCa in~     Denmark has never been applied. Therefore, this project is carried out in order to evaluate~     the use of modern mMRI in the diagnosis of prostate cancer in a Danish setup.~   "
147159|NCT01640249|"~     The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it~     causes any side effects. The study will also measure how much of the study drug gets into the~     blood stream and how long it takes the body to get rid of the study drug. The study drug will~     be given in the morning or evening with or without a meal.~      This is the first time that this study drug is being given to humans. This study is for~     research purposes only and is not intended to treat any medical condition.~   "
147160|NCT01640236|"~     This is a longitudinal Feasibility Study of a novel non-invasive device in assessing~     radiation dose exposure in humans. All patients receiving whole body irradiation therapy and~     meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements~     and slit-lamp examinations on up to eleven occasions starting prior to the first fractional~     dose of irradiation.~   "
147161|NCT01640223|"~     The aim this study is the acquisition and management of a data base for the development of~     the glycaemic regulation algorithms. This database will integrate the measures of blood~     glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of~     insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database~     will also contain the bolus of insulin injected at meals and the content of meals, the~     reduction insulin level during physical activity and the quantification of this physical~     activity. A study will also be conducted to compare the pharmacokinetics of a bolus of~     insulin identical with the JewelPUMP either the usual pump of the patient.~   "
147162|NCT01640210|"~     The main objective of the study is to verify the reliability of the solutes volumes issued by~     the Debiotech JewelPUMPTM controlled by its remote.~      Three clinical sites are participating in this study:~        -  CHSF, Service of Endocrinology and Diabetology, CORBEIL-ESSONNES (91): Dr. Guillaume~          CHARPENTIER, Dr. Sylvia FRANC~        -  Grenoble University Hospital, Department of Endocrinology, Diabetes Diseases, Nutrition,~          GRENOBLE (38): Pr Pierre-Yves BENHAMOU~        -  CHU Jean Minjoz, Department of Endocrinology and Diabetology, BESANCON (25): Professor~          Alfred PENFORNIS, Dr. Annie CLERGEOT~      The study will be conducted in 20 patients with type 1 diabetes treated by external insulin~     pump. Patients will be informed of the study during a screening visit. After signing the~     informed consent, they will return to the center where they will wear a JewelPUMPTM~     containing saline water, they will use their pumps in parallel. The investigator or nurse~     education will form the operation of the JewelPUMPTM and they will be instructed to replicate~     the same settings between their usual and JewelPUMPTM pump. The patient will be asked to~     complete visual analog scales of satisfaction with their usual treatment and the various~     elements of the devices (usual pump, and JewelPUMPTM) have been weighed using a precision~     balance to have a form of a base for comparison.~      Patients will leave home for a period of about three days, but they will have to come back~     every days to the center. They will be asked to collect all events arising (programming~     problems to deliver a bolus, hardware failure ...) in a booklet.~      At the end of study visit, patients will return to the center where the volumes will be~     assessed by the perfused weighed the various components and devices where they will complete~     the visual analog scales of satisfaction at endpoint.~   "
147163|NCT01640197|"~     The effects of chronic resveratrol supplementation have yet to be investigated in healthy~     humans. It is hypothesised that the effects will be different to those seen in acute~     supplementation. This study will look specifically at cognitive performance, cerebral blood~     flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It~     is hypothesized that these measures will be affected differently by acute and chronic~     supplementation.~   "
147164|NCT01640184|"~     It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney~     disease (CKD) patients who had not succeeded medical therapy and could not get~     parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable~     alternative treatment that help control secondary hyperparathyroidism in CKD patients~     presenting with enlarged parathyroid gland(s) visible at ultrasonography.~   "
147165|NCT01640171|"~     Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related~     macular degeneration, retinal vein occlusion, and diabetic macular edema are being~     administered in the United States at increasing rates. A 2010 study showed that in Canada and~     the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000~     citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal~     injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the~     four doctors in my retina group administered a total of 6,494 intravitreal injections; in~     2010, we administered 5021 intravitreal injections.~      Even though intravitreal injections are commonly administered, the optimal method of~     anesthetizing the eye prior to injection has yet to be determined. Some physicians use an~     anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use~     subconjunctival injected anesthetic.~      In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the~     American Society of Retina Specialists (the largest retina society in the world) asked about~     anesthetic methods for administering intravitreal injections, the following response was~     given by the 433 respondents:~        -  Topical anesthetic drop: 21.48%~        -  Topical viscous anesthetic: 23.33%~        -  Topical anesthetic & soaked cotton-tip or pledget: 29.79%~        -  Subconjunctival injection of anesthetic: 24.02%~        -  Other: 1.39%~      An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing~     optimal anesthetic prior to intravitreal injections. (Prenner 2011).~   "
147166|NCT01640158|"~     The primary objective of this study is to evaluate the effects of plasticity-based, adaptive~     cognitive remediation on the cognitive abilities, functional status and quality of life of~     soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a~     mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as~     compared to a computer-based control.~   "
147167|NCT01640145|"~     Maintenance of skeletal muscle mass is crucial during lifespan to retain health and~     functional autonomy. Sarcopenia, being the loss of muscle mass during aging, is a well-known~     phenomenon in the elderly and a major challenge viewed from an individual, and a~     socioeconomic point of view. Nevertheless, several studies have proved muscle tissue to be~     markedly affected by physical activity and nutritional interventions even at old age.~     Recently, a study in young individuals showed that an acute bout of easily tolerated low~     intensity exercise can prolong the muscle building effects of a milk protein intake compared~     to a non-exercised situation. Therefore, the major aim of the present project is to evaluate,~     whether a low intensity exercise regime in conjunction with milk protein supplementation can~     induce positive adaptations on parameters related to muscle size and function in elderly.~      The study focuses on the acute muscle protein synthesis response to low intensity exercise~     and protein supplementation measured with stable isotope tracer techniques. It is~     hypothesized that light muscle activity can augment and prolong the effects of protein~     feeding.~      If a light resistance exercise protocol as investigated in the present project can prove~     beneficial, elderly, frail elderly, and individuals undergoing rehabilitation can challenge~     sarcopenia in a new and tolerable way.~   "
147168|NCT01640119|"~     The investigators want to evaluate whether an original action based on the administration of~     alkali (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce~     mortality due to cardiovascular events.~      Methods: This is a proposal of Multicentric, prospective, cohort, randomized, open-label and~     controlled study.~      The investigators will Randomize 728 patients with Chronic Kidney Disease(CKD) stage 3b~     (CKD-3b) and CKD stage 4: 364 of these patients will be included in the study group called~     Bicarbonate Group (Bic), in which levels of bicarbonate should be kept > 24 mEq/l; the other~     364 patients will included in the Usual Treatment Group (no-Bic).~      Results: The aim of the Research Protocol is to demonstrate if that the optimal correction of~     uremic acidosis (with administration of sodium bicarbonate or of any other alkalinizing~     agent, e.g. sodium citrate) reduces renal and cardiovascular mortality.~      Conclusions. In conclusion the Work Group of the Conservative Therapy for Chronic Renal~     Insufficiency proposes this cohort, randomized, controlled, prospective, multicentric study~     to evaluate the effects of correction of acidosis on the progression of the kidney disease~     considered as renal death in End-Stage Renal Disease (ESRD) patients.~   "
147172|NCT01640067|"~     Primary aim of the trial~        1. to verify safety and tolerability of expanded human fetal neural stem cells~        2. to verify safety and tolerability of a microsurgery human fetal neural stem cells~          transplantation model~        3. to recognize each change in patient's quality of life~      Secondary aim of the trial~        1. assessment of the impact of human neural stem cells transplantation on the disability of~          ALS in a clinically significant and measurable way~        2. Assessment of the impact of human neural stem cells transplantation on mortality (all~          causes)~   "
147173|NCT01640054|"~     The purpose of this study is to evaluate the long term safety and tolerability of~     fostamatinib in patients in Asia with rheumatoid arthritis (RA).~   "
147174|NCT01640041|"~     The purpose of this study is to test an innovative, advanced FNS microstimulator technology~     developed by the Alfred Mann Foundation (Santa Clarita, CA) called, the Radio Frequency~     Microstimulation (RFM) Gait System that promises to provide FNS training for restoration of~     functional gait components in a manner at least as efficacious as current investigational FNS~     systems. The design features of the RFM Gait System are intended to address the problems with~     the current FNS systems. The RFM implant devices are small enough to be inserted using only a~     5 mm incision[3]. Because both the electrode (anode and cathode) are contained within the~     microstimulator, there are no lead wires traversing the skin, joints, or torso/limb~     junctures. Individual RFMs can be inserted at the motor points and nerves of each of the~     paretic muscles in the involved limb and coordinated using radio frequency technology.~   "
147175|NCT01640028|"~     The purpose of this study is to analyze the relationship between sebum excretion rate and the~     following factors:~        -  Hormone levels (testosterone, dehydroepiandrosterone sulfate)~        -  Expression of 5-α-reductase type 1 (a protein in sebaceous glands that transforms a~          hormone (testosterone) into another one that strongly stimulates sebum production)~        -  Diet~        -  Sun and ultraviolet light exposure.~        -  Facial washing routine~        -  Sleep patterns (time when you start sleeping and total sleep time)~      This study will analyze the relationship between sebum excretion rate and the various factors~     that may influence it in approximately 40 subjects. It will be conducted in one center~     located in Montreal. All devices are known and have already been used in the past.~   "
147176|NCT01640015|"~     The primary purpose of this study is to identify the effect of meal frequency on blood~     pressure (BP) levels of individuals.~   "
147177|NCT01640002|"~     It's a double blind, placebo controlled study to assess the efficacy of Propantheline Bromide~     to treat overactive bladder (OAB) in HTLV 1 infected patients.~      We think that the treatment of the OAB with Propantheline could reduce nocturia and frequency~     in sixty percent.~   "
147178|NCT01639989|"~     In this study we will try to show that performing Doppler of the Spiral arteries is doable.~     No outcome will be followed at this stage~   "
147179|NCT01639976|"~     Testing the whether Doppler studies after cytotec treatment can predict success of treatment.~   "
147180|NCT01639950|"~     Background:~      - Assessing pain levels is important to improve treatments for different illnesses. Most pain~     rating scales are used to determine pain levels in adults. Pain is also a common symptom~     among children who have cancer. Those who have genetic conditions that may lead to cancer may~     also have pain symptoms. However, the pain scales used for adults have not been fully tested~     in children and young adults. As a result, they may not be as accurate. Researchers want to~     test pain rating scales in children and young adults who have cancer and genetic conditions~     that can lead to cancer.~      Objectives:~      - To study the effectiveness of pain rating scales given to children and young adults with~     cancer and related genetic conditions.~      Eligibility:~        -  Children, adolescents, and young adults between 18 and 34 years of age who have cancer~          or other genetic conditions that can lead to cancer.~        -  Parents of participating children will also be eligible.~      Design:~        -  Participants with cancer or related genetic conditions will fill out four~          questionnaires. These questionnaires will ask about pain levels and how much pain~          interferes with daily life.~        -  Parents will fill out two questionnaires about their child s pain levels and how much~          pain interferes with the child s life.~        -  Pain treatments will not be provided as part of this study.~   "
147181|NCT01639937|"~     Background:~      - People with congenital heart disease may develop heart failure earlier that those who do~     not have the disease. One theory to explain this is that the heart s own blood supply may be~     different in people with congenital heart disease. Problems with this blood supply can~     severely damage the heart. This damage can be studied with a heart imaging test called a~     cardiac magnetic resonance imaging (MRI) scan. Researchers want to use this type of scan to~     look at the blood supply to the heart in people with congenital heart disease.~      Objectives:~      - To learn more about the blood supply to the heart in people with congenital heart disease.~      Eligibility:~      - Individuals at least 18 years of age who have heart defects caused by congenital heart~     disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have a cardiac MRI scan to look at the blood flow to the heart.~        -  Participants will also have a heart stress test to measure heart function during~          exercise.~        -  Other imaging studies of the heart may be performed to collect more information on heart~          function.~   "
147213|NCT01639521|"~     This study is about two chemotherapy study drug combinations (regimens) that are used for~     urothelial (bladder or upper urinary tract) cancer. Both study drug regimens, gemcitabine~     (gemcitabine hydrochloride) plus cisplatin, and high-dose-intensity MVAC (methotrexate,~     vinblastine, doxorubicin plus cisplatin), are standard chemotherapy regimens. Both regimens~     are used to treat people with urothelial cancer that has spread to other organs. Both study~     drug regimens have been proven to be effective in lowering the risk of the cancer coming~     back, but it is not known which regimen is the best. This study hopes to learn whether there~     is a difference in the effectiveness and side effects of these two study drug regimens when~     they are given to people who have had their urothelial cancer completely removed.~   "
147276|NCT01638702|"~     Peripherally inserted central catheter (PICC) are catheters that are placed mainly in the~     arms, but which pass in the veins to beside the heart. They are associated with occasional~     complications due to infection or blockage of the vein that they are in. The investigators~     want to investigate whether PICCs in the right arm have lower complications than those in the~     left. This difference in complication rates has been noticed in most other forms of central~     venous access.~   "
147182|NCT01639924|"~     Background:~      - Gastrointestinal diseases and disorders affect the throat, stomach, and intestines. There~     are many different kinds of these diseases. Clinical trials are being developed to study new~     ways to treat them. People who are interested in clinical trials need to be screened before~     they can take part in the studies. Researchers want to evaluate people with different stomach~     and intestine disorders to see if they are eligible for clinical trials.~      Objectives:~      - To study people who have gastrointestinal disorders and see if they are eligible for~     clinical trials.~      Eligibility:~      - Individuals at least 18 years of age who have or may have a gastrointestinal disorder.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood, urine,~          and stool samples will be collected. Imaging studies such as x-rays and ultrasound will~          check to see if the disorder has affected other organs.~        -  Participants may have tests as needed depending on their disorder. These tests include~          the following:~        -  Colonoscopy and endoscopy of the large intestine, esophagus, and stomach.~        -  Stomach acid analysis to look at stomach pH levels.~        -  Wireless capsule endoscopy to take pictures of the small intestine.~        -  Hydrogen breath testing to study issues like bloating, diarrhea, and constipation.~        -  Sitz Marker Study to see how fast stool moves through the colon.~        -  Participants may donate extra blood, urine, or stool samples for study. They may also~          donate stomach contents or tissue from the gut.~        -  Treatment will not be provided as part of this study. However, participants may be~          admitted to other clinical trials.~   "
147183|NCT01639911|"~     This phase I trial using the EffTox design will evaluate activity and safety of alisertib, an~     Aurora A kinase inhibitor, when given in combination with the selective VEGFR inhibitor~     pazopanib in patients with advanced, previously treated non-hematologic solid tumors.~   "
147184|NCT01639898|"~     POEMS syndrome is a rare form of B cell dyscrasia combining a proliferation usually of plasma~     cells, a polyneuropathy, osteocondensing bone lesions and multiple other clinical signs.~     Lenalidomide appears to be particularly efficient in this pathology.~      The investigators propose a phase II multicentre protocol, based on the use of lenalidomide~     combined with dexamethasone in patients presenting a POEMS syndrome, either de novo or~     resistant or in relapse.~      Patients who can be treated by local radiation or intensive treatment with stem cell support~     will undergo 2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before~     radiation or intensive treatment (Group 1), the other patients will undergo 9 cycles of the~     Len-Dex combination (Group 2).~      A biological study is coupled with this clinical protocol in order to define the best~     biological markers predicting clinical responses, to better understand the POEMS~     pathophysiological mechanisms and to set up a bank of samples which can be used to study this~     rare pathology.~   "
147185|NCT01639885|"~     This study investigates the feasibility and immunogenicity of the triple combination of~     gemcitabine, Peg-Intron and p53 SLP vaccination in patients with platinum-resistant ovarian~     cancer.~   "
147186|NCT01639872|"~     Many individuals with schizophrenia also suffer from marijuana addiction that worsens their~     problems related to schizophrenia. Most of the medications prescribed for schizophrenia have~     no effect on reducing marijuana use. Preliminary data suggests that clozapine, an atypical~     antipsychotic, may limit marijuana use in people diagnosed with schizophrenia, but it is not~     commonly used due to its side effects and is reserved for people who do not respond to other~     antipsychotic medications.~      In the proposed study, 132 individuals who are diagnosed with both schizophrenia and a~     cannabis use disorder will be randomized to a 12-week treatment course with either clozapine~     or risperidone (another commonly prescribed antipsychotic medication) to test the hypothesis~     that patient treated with clozapine will have decreased cannabis use as compared to patients~     treated with risperidone.~      Should this study indicate that clozapine will lessen marijuana use in persons diagnosed with~     schizophrenia more than risperidone, it will provide evidence needed to begin to shift~     clinical practice toward its use in this population.~   "
147187|NCT01639859|"~     The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous tumor~     foci, of normal peripheral zone, and of normal transition zone in the prostate. Images~     obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are~     compared to whole-mount histology.~   "
147188|NCT01639846|"~     To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic~     solution in alleviating the signs and symptoms of allergic conjunctivitis~   "
147189|NCT01639833|"~     The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic~     Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in~     subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve~     replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair,~     etc.), or CABG.~   "
147190|NCT01639820|"~     Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic~     lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the~     classical surgical treatment including identification of the sentinel nodes, full pelvic~     lymph-node dissection and radical hysterectomy.~      The experimental arm is only sentinel node identification + radical hysterectomy.~   "
147191|NCT01639807|"~     The purpose of this study is to compare Selective laser trabeculoplasty (SLT) and topical~     medications for initial treatment of open-angle glaucoma /Ocular Hypertension based on~     intraocular pressure reduction, treatment side effects, quality of life measures and costs in~     South Indian Population.~   "
147214|NCT01639508|"~     The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good~     and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or NTRK~     fusion, or increased MET or AXL activity.~      A phase II study looks at how effective a medication is at treating a specific type of cancer~     and collects information on the side effects of the study treatment.~      RET, ROS1, or NTRK fusion or increased MET or AXL activity gene leads to lung cancer cell~     growth. Cabozantinib is an oral medicine that inhibits of RET, ROS1, NTRK, MET, and AXL. In~     addition, this drug interferes with other cell pathways that also cause cancer cells to grow,~     form new blood vessels, and spread to other organs of the body. The goal of using~     cabozantinib is to shrink the cancer and to prevent it from growing~      Cabozantinib has been studied and shown to cause cancer shrinkage in other cancers such as~     medullary thyroid cancer and prostate cancer. We thus have a good idea of what side-effects~     it causes and can anticipate them.~   "
147192|NCT01639794|"~     This is an observational study which will look at the improvement in Lower Urinary Tract~     Symptoms (LUTS) in Irish men being treated with Vesitirim™ (solifenacin).~      Vesitirim™ is a competitive specific muscarinic receptor antagonist and has been used~     extensively for the treatment of OAB (Over Active Bladder) in women and has shown significant~     impact on urgency, frequency and incontinence in females. It is also indicated for the~     symptomatic treatment of urgency incontinence and/or increased urinary frequency and urgency~     in men. The purpose of this study is to evaluate LUTS storage symptom improvement in men with~     non neurogenic LUTS who have been prescribed Vesitirim™.~      The effect of Vesitirim (solifenacin) treatment on bothersome symptoms improvement will be~     measured using Over Active Bladder-q Short Form (OAB-qSF) and the Perception of Treatment~     Satisfaction (TS-VAS). The study will also help define some of the characteristics of the~     male population in Ireland who are treated with Vesitirim™ (solifenacin) as well as~     evaluating the effect of Vesitirim™ monotherapy or combination therapy on storage symptoms~     improvement (urgency, frequency and urge incontinence) using a bladder diary and IPSS~     (International Prostate Symptom Score). The study will also evaluate the effect of Vesitirim™~     monotherapy or combination therapy on nocturia using IPSS. The impact of LUTS on quality of~     life will also be assessed. Data will also be collected regarding adverse drug reactions.~   "
147193|NCT01639781|"~     Epidemiological studies suggest that certain foods rich in flavanols, including cocoa~     products, red wine, and tea, are associated with decreased cardiovascular mortality and~     morbidity. Dietary interventional studies have corroborated this finding and showed that~     flavanols can acutely and after sustained ingestion improve surrogate markers of~     cardiovascular risk including endothelial function. Endothelial dysfunction is the key event~     in the development and progression of cardiovascular disease. Aging is the major~     non-modifiable cardiovascular risk factor associated with progressive decline in endothelial~     function, vascular stiffening and increase in blood pressure. We hypothesize that flavanols~     can counteract age-dependent vascular changes by interacting with key mechanisms, most~     prominently endothelial function.~   "
147194|NCT01639768|"~     The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based~     on reduction of upper airways reactivity after 5 months of treatment with different dosages~     of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be~     assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch~     compared to placebo.~   "
147195|NCT01639755|"~     The purpose of this study is to obtain clinical experience with the use of new texture,~     shaped breast implants in bilateral primary breast augmentation.~   "
147196|NCT01639742|"~     The purpose of this study is to obtain clinical experience with the use of new texture, round~     breast implants in bilateral primary breast augmentation.~   "
147197|NCT01639729|"~     Determine whether the amount of drug absorbed is different if the tablet is placed under the~     tongue, placed between the cheek and gum, or swallowed.~   "
147198|NCT01639716|"~     The investigators hypothesized that Non Hodgkin lymphoma is using T helper 2 pathways. So~     that the investigators decided to study of cytokines related to T helper 2 pathways. It is~     well known that parasites and allergic situations also use T helper 2 pathways. Because that~     the investigators excluded the patients have parasites and allergic situations. All the~     patients were over 18. The investigators included the patients with non Hodgkin lymphoma~     which new diagnosed. It is observational study. The investigators took blood before~     chemotherapy and four months later. The investigators did not interfere with which~     chemotherapy will be given to patients. This decision was belong to hematologist or~     oncologist who will treat the patient.~   "
147199|NCT01639703|"~     The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT~     perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC)~     and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the~     aim to cover the entire liver.~   "
147200|NCT01639690|"~     The patient has inherited ß-thalassemia major through the genes. These genes have mistakes in~     them, so the body cannot make normal red blood cells. Stem cells are made in the bone marrow.~     They are the earliest form of blood cells.~      This study is being done to see if the investigators can make the stem cells produce normal~     red blood cells and hemoglobin. The investigators do this by collecting the stem cells. The~     genes with mistakes are removed from the cells. These cells are then treated so they have the~     corrected gene for making normal hemoglobin. These treated cells are given back to the~     patient through an injection (shot) in the vein. This is also known as gene transfer. In~     order for the body to accept these cells, the patient will need to receive a low dose of a~     drug called busulfan. It is a drug that will prepare the body to receive the new stem cells.~      This study will let the investigators know:~        -  If it is safe to give the patient the treated stem cells~        -  If the treated stem cells will go into the bone marrow without causing side effects.~      Gene transfer has been used for the past five years. It has been successful in treating many~     blood disorders. At least 20 patients have received the type of treatment that the patient~     will get on this study. This treatment for B-thalassemia major was developed here at Memorial~     Sloan Kettering (MSK). It was studied for a long time in the lab before being given to~     patients.~   "
147201|NCT01639677|"~     This is a randomized clinical trial assessing the outcome of two surgical strategies to treat~     severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss~     and weight loss maintenance but other factors as body composition, eating pattern, metabolic~     normalisation, energy expenditure will also be assessed.~   "
147202|NCT01639664|"~     The study objective is to clarify whether the application of high doses CPFA (coupled~     plasma-filtration adsorption) in addition to the current clinical practice is able to reduce~     hospital mortality in septic shock patients in intensive care unit (ICU).~   "
147215|NCT01639495|"~     This is a prospective, multicenter, non-randomized continued access clinical evaluation~     utilizing the THERMOCOOL® SMARTTOUCH™ catheter.~   "
147277|NCT01638689|"~     Healthy males were examined with positron emission tomography (PET) and the radioligand~     11C-AZ10419369, before and after administration of a single dose escitalopram. A change in~     the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was~     hypothesized to reflect a change in serotonin concentration.~   "
147203|NCT01639651|"~     For many years researchers have been documented that the shoulder of the throwing athlete~     acquires a increase in external rotation of the dominant limb compared to the contralateral~     side.This fact is followed with a loss of the internal rotation of the shoulder, which is~     related with a higher rate of injuries in this joint and it´s known as Glenohumeral Internal~     Rotation Deficit (GIRD).~      Among the approaches for this condition the literature is inconclusive due to the low~     methodological quality of clinical trials made,however, the manual therapy has been used with~     success to relief the pain and restore the range of motion.~      The purpose of this study is to analyse the effectiveness of a mobilization with movement~     technique to improve the internal rotation of the shoulder in throwing athletes with GIRD.~      It will be a randomized controlled trial with the CONSORT bases with 40 participants that~     will be divided into two groups:~        -  Control group that will be submitted for an evaluation of shoulder range of motion~          (internal/external rotation)of both limbs, upper limb active movements to warm-up (five~          minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) and~          revaluation immediately post-intervention and four weeks post-intervention.~        -  Mobilization group that will be submitted for an evaluation of shoulder range of motion~          (internal/external rotation)of both limbs, upper limb active movements to warm-up(five~          minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds)~          plus a mobilization with movement technique to improve internal rotation of the dominant~          shoulder (three sets of 10 repetitions)and revaluation immediately post-intervention and~          four weeks post-intervention.~      To evaluate the range of movement it will be use a standard goniometer with an attached~     customizes bubble inclinometer to ensure proper perpendicular alignment of the goniometer to~     the ground.~      The investigators hypothesis is that both group will have improvements in the internal~     rotation of the dominant shoulder, however, the mobilization group will have a statistically~     significant difference compared to control group immediately post-intervention. Four weeks~     post-intervention this difference will equalize, because of the only intervention applied.~      Results will be expressed as hazard ratios (HR) with their respective confidence intervals at~     95% and adopting α = 0.05. All analyzes will be performed by SPSS version 17.0~   "
147204|NCT01639638|"~     Treatment is considered successful if the difference in the response in the reduction of the~     affected area is above 30% for any of the doses compared to placebo Patients will be~     randomised to 1 of 3 treatment arms~        1. Placebo~        2. CIGB-300 - 5 mg~        3. CIGB-300 - 15 mg~      A two week screening visit will take place to assess patient eligibility, at least 2 to 5~     target lesions (area of the lesion between 20 to 80 mm2), should be identified. Patients~     included in the study will be randomly assigned to one of three study arms. Treatment~     consists of 3 perilesional applications at the base of the target lesion every 48 hours with~     a window of ±24hs.~      After each application the potential local and systemic adverse events will be identified and~     monitored.~      After the last application is made, weekly clinical evaluations for 3 weeks and then every~     two weeks, until week 12 will take place. At this time, clinical assessment of efficacy will~     be carried out that will define the response to treatment.~      After this visit, patients will be followed every 3 months until one year after the last~     treatment has been completed to confirm response and long-term security of the CIGB-300~     application.~      At screening, at 2 and 8 weeks as well as at 6 and 12 months post-treatment blood studies~     will be conducted to assess the safety from the systemic point of view.~   "
147205|NCT01639625|"~     They include patients who are candidates to complete concurrent treatment with endocavitary~     brachytherapy External radiation therapy + more QT based weekly cisplatin.~   "
147206|NCT01639612|"~     1. Purpose of the Study - This protocol aims to demonstrate the feasibility and safety of~     autologous ALD-451 cells administered intravenously in World Health Organization (WHO) grade~     IV malignant glioma patients following surgery, radiation therapy and temozolomide; as well~     as to obtain an initial description of the effects of ALD-451 cells on neuro-cognition~     allowing the design of a subsequent phase 2 trial of this intervention in patients with~     malignant glioma. The primary objective of this study is to demonstrate the safety of~     intravenously administered autologous bone marrow derived ALD-451 cells in the brain~     following surgery, radiation therapy and temozolomide in patients with WHO grade IV malignant~     glioma. The secondary objective of this study is to determine the recovery of ALD-451 from~     bone marrow of patients following radiation therapy and temozolomide. The exploratory~     objective of this study is to determine if intravenous administration of autologous ALD-451~     cells following surgery, radiation therapy and temozolomide in WHO grade IV malignant glioma~     patients may have an effect on subsequent deterioration of neurocognition and~     patient-reported outcomes.~   "
147207|NCT01639599|"~     Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and~     vomiting (PONV). However, precise dose-response studies have not been completed, especially~     in patients at high risk for PONV who require combination therapy. This study sought to~     identify the optimal dose of haloperidol that could be combined with dexamethasone without~     adverse effects in high-risk PONV patients receiving intravenous patient-controlled~     anesthesia (IV PCA) after gynecological laparoscopic surgery.~   "
147208|NCT01639586|"~     One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to~     helping families. It's also of major to involve the patient in the most active treatment~     possible, encouraging social inter relationship as well as cognitive and behavioural~     stimulation activities.~      In the frame of non drug related approaches to Alzheimer disease (AD), several research~     projects and actions have already been conducted, but no specific study concerning the~     efficiency of different types of respite care structures have been conducted so far in~     France. The present project concerns the thematic of the frame Development and~     diversification of respite care structures.~      A platform is defined in the Alzheimer Plan as a diversified range of despite structures~     according to patients' needs and informal caregivers' expectations providing several~     objectives:~      Two objectives targeting the informal caregivers:~        -  offer spare time or tutored~        -  inform, support and accompany~      Two objectives targeting the patients:~        -  encourage maintain of the patient social life and relationships and work together~          towards his/her psychological and emotional well-being~        -  contribute to improve functional cognitive and sensory capacities~      The study COMPARSE suggests to compare for the patient - informal caregiver couple, the~     impact of three different groups of patient care on health profit; resit platform (P), the~     day care group (D), the control group without access to a respite structure (C).~   "
147209|NCT01639573|"~     This phase I/II pilot trial seeks to demonstrate that prolonged administration of Campath-1H~     without prior marrow or stem cell harvesting can result in immunoablation similar to that~     achieved by hematopoietic stem cell transplantation (HSCT) from either bone marrow or~     peripheral blood stem cell sources in children and adolescents with severe treatment~     refractory systemic sclerosis (SSc).~   "
147210|NCT01639560|"~     The purpose of this study is to determine if varenicline is effective in treating tobacco~     dependence in adults who smoke 5-10 cigarettes per day.~   "
147211|NCT01639547|"~     The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD)~     plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the~     clearance of HCV viremia 24 weeks after treatment end~   "
147216|NCT01639482|"~     Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using~     18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).~     The following hypothesis will be tested: Antidepressant response or remission in depressed~     BPD patients will be associated with changes in cortical (prefrontal, parietal, premotor) and~     paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior cingulate, and~     anterior insula) regions, consistent with SRI antidepressant response in unipolar depressed~     patients.~   "
147217|NCT01639469|"~     This project is investigating whether a one-year in-home exercise program will reduce the~     rate of falls and improve strength and quality of life in patients with Parkinson's disease.~   "
147218|NCT01639456|"~     This is a phase II trial designed to test the safety and efficacy (disease free survival~     [DFS]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute~     myelogenous leukemia (AML). The natural killer (NK) cell product will be given to patients 60~     years and older who are in a first complete remission after 1 or 2 courses of standard AML~     induction. After a preparative regimen of cyclophosphamide and fludarabine, patients will~     receive a single infusion of either CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a~     short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.~   "
147219|NCT01639443|"~     In this research study, investigators use colonoscopy as a case example to evaluate a~     predictive overbooking model derived using patient-level predictors of absenteeism. The~     no-show overbooking intervention employs a logistic regression model that uses patient data~     to predict the odds of no-showing with 80% accuracy. These projected no-show appointments~     will be overbooked by clerks for patients who agree to join a fast track short-call line.~     By rapidly processing endoscopy patients and moving them out of traditional slots,~     investigators predict more scheduling slots would become available for patients awaiting~     colonoscopy.~   "
147220|NCT01639430|"~     Retrospective analysis of a quality measurement project examining the quality of vital~     parameter measurement in consecutive patients >= 75 years presenting to the emergency~     department.~      Primary goal of the study is to evaluate the diagnostic accuracy of body temperature~     measurement using different methods to diagnose infection in patients >= 75 years presenting~     to the emergency department. The secondary goal is to compare the reliability of tympanal and~     temporal artery thermometry with rectal temperature measurement.~   "
147221|NCT01639417|"~     The purpose of this study is to better understand why some women with breast cancer develop~     chronic pain.~   "
147222|NCT01639404|"~     This study aims to evaluate the efficacy of umbilical cord blood therapy for children with~     cerebral palsy.~   "
147223|NCT01639391|"~     Patients with ALS will be included in the reference center for ALS in hospital La Pitié~     Salpêtrière, Paris.~      The study proposes to investigate the pathophysiology of ALS by setting up a fibroblast bank~     for studying molecular, cellular and genetic parameters of the pathology.~      iPS (induced pluripotent stem cells) and then differentiated cells will be generated.~      The pathophysiology of ALS will be studied on the 3 types of cells (fibroblasts, iPS,~     differentiated cells).~   "
147224|NCT01639378|"~     The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety~     and effectiveness of renal denervation in subjects with chronic systolic heart failure.~     Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system~     that delivers radio frequency (RF) energy through the luminal surface of the renal artery.~   "
147225|NCT01639365|"~     The pressure exerted by the ablation catheter on the tissue has been shown to play an~     important role on determining the size and the potential efficacy of the ablation lesions. A~     direct information on the force exerted by the catheter tip obtained from the SmartTouch~     technology might improve the assessment of the scar areas during electroanatomical mapping in~     patients with ventricular tachycardia (VT) due to ischemic disease or cardiomyopathy. The~     objectives of the study are to compare the areas of scar (defined as a low-voltage threshold)~     obtained from the conventional voltage map with those obtained after the contact map~     information is available to the operator and to determine if the availability of the contact~     information allows an improvement of the electroanatomic map by correcting the points taken~     in no-contact areas. Twenty to 30 consecutive patients with ventricular arrhythmias due to~     ischemic heart disease or dilated cardiomyopathy undergoing VT ablation will be included in a~     prospective, one-center, non-randomized study. A voltage map of the left ventricle will be~     obtained using the CARTO-3 navigation system and the scar areas as well as the areas of~     potential interest for ablation will be delineated in the standard way and saved as the~     control map. The force information will be recorded by the system but will not be available~     to the operator until the control map is saved. Following this step the contact map will be~     available to the operator to be compared with the control map and further mapping and point~     acquisition will be allowed to correct the areas previously acquired with poor or no contact.~     The final map after corrections have been made will be saved as the corrected map. The~     ablation procedure will then be performed as usual. Both maps will be compared in a deferred~     way to know how are classified the areas without contact when no pressure information is~     available, and how many non-contact points are falsely assumed to be low-voltage or dense~     scar points. These comparisons will give information on how much the standard electroanatomic~     map can be improved when the force information is added.~   "
147226|NCT01639352|"~     The hypothesis of this clinical trial is that hepatocellular carcinomas contain somatostatin~     receptors which make them sensitive to the inhibitory effects of a new somatostatin analog,~     SOM230. This analog has greater and broader binding affinity to somatostatin receptors~     compared to the current drug in use, sandostatin LAR. Thus, SOM230 has the potential to be~     more effective in the treatment of patients with hepatocellular carcinoma.~   "
147227|NCT01639339|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab~     in adult patients with active lupus nephritis.~   "
147228|NCT01639326|"~     This study aims to use the corresponding pharmacogenetic analysis to increase the dose of~     irinotecan in the schemes commonly used standard chemotherapy in advanced colorectal cancer~     treatment first. The project aims to improve the therapeutic index of chemotherapy. This~     optimization is raised based on the administration of different doses of the drug depending~     on the genotype UGT1A1 gene. The research team proposes this project to demonstrate how the~     administration of high doses of irinotecan in the FOLFIRI scheme in patients with genotype~     UGT1A1 favorable (wild homozygous * 1 / * 1 and heterozygous * 1 / * 28), significantly~     improves the efficiency of the antineoplastic agent without significant increase in toxicity.~     Secondarily will assess the possible prognostic factors related to tolerance and efficacy.~      The primary objective is to evaluate the efficacy of high doses of irinotecan in the FOLFIRI~     scheme in patients with metastatic colorectal cancer with a favorable genotype UGT1A1 (wild~     homozygous * 1 / * 1 and heterozygous * 1 / * 28).~   "
147229|NCT01639313|"~     A growing interest in monitoring cardiac output (CO) non-invasively has emerged, however its~     determination has been difficult using the standard approaches. The aim of the study is to~     evaluate the accuracy and precision of pulse contour analysis (PCA) as compared to cardiac~     magnetic resonance imaging (CMR).~   "
147230|NCT01639300|"~     The purpose of this study is to assess the safety and tolerability of single ascending doses,~     as well as of repeated administrations of GNbAC1 in MS patients.~      Scientific research has shown that the expression of genes of a virus which is integrated in~     the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a~     critical role in the causation of multiple sclerosis.~      GNbAC1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of MSRV~     that might contribute to the development or deterioration of multiple sclerosis.~   "
147231|NCT01639287|"~     There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically~     painless synovitis in the hands.~      The objective of this study is to compare painless synovitis with painful synovitis according~     to the sonographic (Gray-scale and power Doppler) findings.~      A sonographic examination (Gray-scale and power Doppler) will be done to evaluate~     metacarpophalangeal joints of patients without local painful and will be a comparison with~     patients with local painful.~   "
147232|NCT01639274|"~     Highly active antiretroviral therapy (HAART) has considerably improved survival of~     HIV-infected patients. Opportunist diseases and cancers linked to immunodepression have~     largely regressed. Challenge is now the management of cardio-vascular diseases, nephrologic,~     neurologic, osteo-articular diseases, chronic hepatitis and cancer no linked to~     immunodepression. All this comorbidities are more reported in HIV-infected patients than in~     general non-HIV infected patients. Those are directly linked to the effect of chronic~     HIV-infection on ageing, metabolic effects of HAART, and way of life characterising this~     population.~      Chronic obstructive pulmonary disease (COPD) results from tobacco consumption. Bronchial~     chronic infection, immunity, and ageing are also involved in the physiopathology of COPD.~     This disease has never been evaluated in a large prospective cohort of HIV-infected patients~     whereas there is a known increase of tobacco consumption and pulmonary infection in this~     population regardless to the general population.~      Characterisation of COPD disease in HIV patients will allow us to make an hypothetic~     epidemiological link between HIV- HAART and COPD independently of tobacco consumption, and to~     study different physiopathologic hypothesis evocated in COPD genesis, like an accelerate~     pulmonary ageing.~   "
147233|NCT01639261|"~     Improvement of quality of life in patients with BO and establishment of a new third line~     therapy~   "
147234|NCT01639248|"~     The purpose of this study is to determine the activity of ENMD-2076 as defined by the~     clinical benefit rate when patients with previously treated locally advanced or metastatic~     triple negative breast cancer are treated with daily oral ENMD-2076.~   "
147235|NCT01639235|"~     This is a study on a population of flight attendants who were exposed to occupational~     secondhand tobacco smoke (SHS). This research will examine associations between flight~     attendant SHS exposure and development of respiratory illnesses, reproductive problems, and~     cardiovascular diseases.~   "
147236|NCT01639222|"~     The purpose of this study is to demonstrate that the intestinal absorption of calcium from a~     newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount~     of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to~     baseline.~   "
147237|NCT01639209|"~     The purpose of this research study is to compare the outcomes of pneumatic retinopexy with~     the outcomes of vitrectomy (with or without scleral buckle) for the management of retinal~     detachment, in terms of anatomical success, functional success and impact on patient quality~     of life.~   "
147238|NCT01639196|"~     The purpose of this study is to explore the effects of writing about chronic pain on mental~     and physical health. The effectiveness of two different types of brief online writing~     interventions will be explored in individuals with chronic pain.~   "
147239|NCT01639183|"~     The purpose of this study is to investigate whether brushing the teeth of nursing home~     residents with a power toothbrush as compared with standard care typically provided in~     nursing homes, will increase caregiver compliance with the provision of daily oral care as~     well as lower oral and systemic inflammation.~   "
147240|NCT01639170|"~     The aim of this study is to evaluate if the presence of abdominal free air on a plain chest~     radiograph predicts gastrointestinal perforation. We aimed to enroll all patients undergoing~     abdominal surgery reporting major symptoms and signs suggestive of gastrointestinal~     perforation (abdominal pain, leukocytosis, fever) within the third postoperative day.~   "
147241|NCT01639157|"~     Cocaine use disorders are an unrelenting public health concern. Intensive research efforts~     have yielded behavioral interventions that reduce cocaine use, however, these interventions~     are not universally effective and treatment effects diminish over time. Development of a~     pharmacotherapy that enhances the efficacy of these interventions is a priority for the~     National Institute on Drug Abuse. This study proposes to determine the impact of buspirone~     maintenance on self-administration of cocaine and alternative reinforcers. These preliminary~     data will be used to support further research developing buspirone as a pharmacotherapy for~     cocaine use disorders. We hypothesize that buspirone will attenuate the reinforcing effects~     of cocaine and increase the reinforcing effects of alternative reinforcers.~   "
147242|NCT01639144|"~     The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing~     incision helps prevent infection and slow wound healing.~   "
147243|NCT01639131|"~     Determine the efficacy of combination Gemcitabine and Docetaxel chemotherapy in the treatment~     of metastatic colorectal cancer with CHFR and/or Microsatellite Instability (MSI) phenotype.~   "
147244|NCT01639118|"~     Primary ventral hernias, such as umbilical and epigastric hernias, are best repaired with~     abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh~     technology have been developed for the specific indication of small ventral hernias; this~     technique is very attractive because the mesh can be introduced through a nearly invisible~     scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the~     viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No~     literature is available on the adequate size of mesh needed to repair a hernia defect of an~     umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a~     large mesh device. Small hernias might benefit of repair with a small mesh device so no~     enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size~     to have more overlap of the mesh beyond the hernia defect.~      With this prospective cohort study the investigators want to explore the efficacy of C-QUR~     V-Patch of different sizes for the different sizes of hernia defects.~   "
147245|NCT01639105|"~     Rationale The cosmetic aspect of scars is a frequent reason for consultation. It plays an~     important role in patient satisfaction and self-image. Several treatment modalities are~     proposed for scars with variable success.~      Ablative fractional laser treatment is a rather new concept. Many microscopic small laser~     beams target the dermis in a grid pattern. The vertical columns of skin hit by the laser~     beams heat up. This thermal effect stimulates the wound healing and potentially leads to a~     remodeling of the skin structure.~      Ablative fractional laser treatment has been used successfully for treatment of pigment~     changes, wrinkles, acne scars and thermal burn wounds. It has been reported that CO2 ablative~     fractional laser treatment has a positive clinical effect on various types of scars however~     this has not been proven yet in a prospective randomized trial. The low morbidity of the~     treatment and the lack of convincing adapted treatment modalities for various types of scars~     make this treatment attractive.~      That's why the investigators aim with this randomized study to evaluate the clinical effect~     and the safety of 10 600 nm ablative fractional laser therapy for patients with recent scars~     due to surgical interventions.~      Goal Evaluate the efficacy of three 10 600 nm ablative fractional laser treatments for the~     above mentioned scars, three months after the last laser treatment, with a prospective~     randomized intra-patient controlled study.~      Study design Prospective single blinded randomized intra-patient controlled study. The study~     comprises 4 study visits.~      Study population The population consists of one group of patients with scars after recent~     surgical operations. The patients must meet the inclusion and exclusion criteria described in~     the protocol.~      Method The scar will be divided in two equal halves. The two halves will be randomized. One~     part will not be treated. The other part will undergo three times the 10 600 nm ablative~     laser therapy with 4 weeks interval between the treatments. The efficacy of the treatment~     will be evaluated three months after the last treatment with objective and subjective~     parameters.~      Most important study endpoints:~        -  Evaluation of the efficacy of the treatment. A blinded clinical scar evaluation will be~          done of the treated and untreated parts with the POSAS scar scale, by a study~          collaborator and by the patient himself, on a category scale of 0 to 10 (0 = normal~          skin, 10 = worst scar imaginable), before start and twelve weeks after the last~          treatment.~        -  Evaluation of the pain related to the treatment. The pain will be scored by the patient~          with the VAS category scale from 0 to 10 (0 = no pain, 10 = worst pain ever).~        -  Evaluation of the side effects of the treatment. A standardized form will be used.~        -  Evaluation of the global patient satisfaction regarding the treatment.~        -  Clinical photos, before start and twelve weeks after the last treatment.~   "
147246|NCT01639092|"~     With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil~     fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by~     polymerase chain reaction (PCR) assays became achievable in most NA treatment-naïve patients.~     Until recently, however, many patients commenced antiviral treatment with inferior NAs prior~     to the availability of TDF or ETV, such as lamivudine (LAM) which has a low genetic barrier~     to resistance.~      ETV resistance increase up to 51% of patients after 5 years of ETV treatment in~     lamivudine-refractory patients. Resistance to ETV appears to occur through a two-hit~     mechanism with initial selection of M204V/I mutation followed by amino acid substitutions at~     rtT184, rtS202, or rtM250.~      In vitro studies showed that ETV-resistant mutations are susceptible to TDF, but there are~     little clinical data on the efficacy of TDF monotherapy in patients with ETV-resistance.~      On the other hand, there was a retrospective cohort study reporting that, with the~     combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6~     months of treatment. Probability of reaching complete HBV DNA suppression was not decreased~     in patients with ADV or ETV-resistance.~      Thus, there is no consistent treatment recommendation for patients with ETV-resistance.~      In this clinical trial, the investigators will clarify whether tenofovir monotherapy is as~     effective as tenofovir plus entecavir in inducing complete virologic response in CHB patients~     with genotypic resistance to ETV and partial virologic response to ongoing treatment.~   "
147247|NCT01639079|"~     The primary goal of this project is to carry out a randomized controlled trial (RCT)~     comparing quit rates of a Spanish/English stop smoking Web site to those of a no-intervention~     or quit on your own control. The investigators have not included a no-intervention~     condition in previous Web studies and although 20% of participants quit smoking at one year~     are 20%, obtaining evidence that the investigators interventions yield higher abstinence~     rates than a no-intervention control is the next logical step. Furthermore, although the~     investigators Web site was designed in English and Spanish, the investigators success in~     attracting the U.S. Hispanic/Latino (HL) population in either language has been limited, so~     this project only will only conduct intensive telephone follow-up of HL smokers and add new~     recruitment methods to do so.~   "
147248|NCT01639066|"~     With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil~     fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by~     polymerase chain reaction (PCR) assays became achievable in most NA treatment-naïve patients.~     Until recently, however, many patients commenced antiviral treatment with inferior NAs prior~     to the availability of TDF or ETV, such as lamivudine (LAM) or adefovir (ADV) which has a low~     genetic barrier to resistance.~      For patients who developed genotypic resistance against ADV, the efficacy of TDF monotherapy~     is controversial. In recent studies, TDF monotherapy produced significant suppression of HBV~     replication. However, only half of patients with initial ADV resistance achieved an~     undetectable viral load (<15 IU/ml) with 48 weeks of therapy.~      On the other hand, there was a retrospective cohort study reporting that, with the~     combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6~     months of treatment. Probability of reaching complete HBV DNA suppression was not decreased~     in patients with ADV or ETV resistance.~      Together, these observations indicate that there is a controversy about the efficacy of TDF~     monotherapy in patients with genotypic resistance to ADV.~      Thus, in this clinical trial, the investigators will clarify whether tenofovir monotherapy is~     effective in inducing complete virologic response compared with tenofovir plus entecavir in~     CHB patients with genotypic resistance to ADV and partial virologic response to ongoing~     treatment.~   "
147249|NCT01639053|"~     This is a ten-year postapproval study to evaluate the long-term clinical performance of~     Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket~     environment.~   "
147250|NCT01639040|"~     The purpose of this study was to assess the safety of Dupilumab administered concomitantly~     with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis~     (AD).~   "
147273|NCT01638741|"~     The purpose of this study is to provide new knowledge about:~        -  Integration of rehabilitation in a highly specialized gynaecological department.~        -  Development and testing of an individually adapted rehabilitation process.~        -  Needs for rehabilitation among women with gynaecological cancer.~        -  Connection between adult attachment style for women with gynaecological cancer and their~          quality of life, rehabilitation needs and symptoms of depression /PTSD.~   "
147274|NCT01638728|"~     The investigators compared the depth of the RAE tube [Preformed oral tracheal tubes were~     first described by Ring, Adair and Elwyn (therefore called RAE tubes)] when fixed at the~     midline and at the angle of the mouth, and after fixing the tube at the angle.~   "
147275|NCT01638715|"~     The purpose of this study is to find biological response patterns of patients with rheumatoid~     arthritis to drugs with different biologic modes of action. This study should help to predict~     therapeutic responses and to find the right therapy for the right patient.~   "
147251|NCT01639027|"~     Reducing the length of labor is a highly desirable goal of intrapartum care, both from a~     perspective of maternal and fetal well-being, and for the providers of the birth services.~     Avoiding along, protracted labor entails shorter exposure to pain, anxiety and stress and~     would thus translate into a major improvement in maternal satisfaction with the childbirth~     experience.~      Based on the premise that shortening the length of labor is beneficial, interventions aimed~     at accelerating the progression of labor have been introduced routinely as part of standard~     labor management and care throughout the 20th century. Certain labor accelerative procedures,~     such as amniotomy, became common practice and have been put to the acid test of randomized~     control trials to evaluate their efficacy. Use of anticholinergics/antispasmodics as a method~     of augmenting labor was ﬁrst described in 1937 by Hirsch, who reported a decrease in labor~     length by two to four hours following Intrapartum administration of an atropine-like drug~     (Syntropan®)mainly among older nulliparas.~      Drotaverine, an isoquinolone derivative is a superior smooth muscle relaxant which acts~     specifically on spastic sites and corrects the cAMP and calcium balance relieving smooth~     muscle spasm.~      This inhibitory action is detected only in lower uterine segment during labor since muscle~     fibers in upper uterine segment are strongly affected by contractile effect of oxytocin. Use~     of drotaverine during pregnancy is free of any teratogenic and embryotoxic effects.~      The Research question is: Does the use of antispasmodic Drotaverine shorten the duration of~     active first stage of labor in nulliparous women as compared to placebo?~   "
147252|NCT01639014|"~     The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake~     inhibitor (SNRI) nin functional recovery after ischemic stroke.~   "
147253|NCT01639001|"~     This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single~     agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in~     First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer~     Patients. The objective of the study is to demonstrate that Crizotinib is superior to~     first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging~     Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose~     tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma~     Kinase) gene locus.~   "
147254|NCT01638988|"~     The results of studies conducted until now does not determine what the best way to treat~     infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study~     objective is to determine the best treatment for such patients. The long-term consequence~     health of women with PCOS are multiple. The woman with PCOS has a risk of developing~     metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin~     resistance plays an important role in all this medical condition. Clomiphene Citrate (CC)~     remains the first line treatment to induce ovulation in women with PCOS and anovulatory~     infertility.~   "
147255|NCT01638975|"~     This study tests a computerized cognitive training program designed for young individuals~     with compulsive hair pulling (also known as trichotillomania;TTM). Research suggests that~     individuals with TTM are characterized by poor cognitive abilities to suppress irrelevant~     response. This ability is called response inhibition. The current study tests a cognitive~     training program designed to improve individuals' cognitive abilities of response inhibition~     through a 8-session computerized training program. The investigators hypothesize that those~     who complete the response inhibition training program will show a greater reduction in hair~     pulling symptoms, compared to those assigned to a waitlist group.~   "
147256|NCT01638962|"~     The purpose of this study is to compare the effects of neuromuscular exercise and analgesic~     use on knee joint load, in patients with mild to moderate knee osteoarthritis (OA).~      It is expected that the two groups will receive equipotent pain relieving effect, despite~     this, the investigators expect a between group difference in knee joint load, and the~     exercise group will have a reduction in knee joint load.~   "
147257|NCT01638949|"~     Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight.~     An early diagnosis of AD is urgently needed as it would constitute a determinant breakthrough~     from a social, financial and research standpoints. Therefore, the investigators need~     predictive markers of AD, and neuroimaging is a particularly promising tool, especially when~     using complementary neuroimaging techniques and a longitudinal design, allowing to assess the~     relationships between the different biomarkers of the disease, their dynamic and their~     chronology.~   "
147258|NCT01638936|"~     The purpose of this study is to test safety and anti-tumor activity of BT062 in combination~     with lenalidomide and dexamethasone to define the best doses for treating patients with~     relapsed and refractory multiple myeloma.~   "
147259|NCT01638923|"~     To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and~     dienogest in the treatment of heavy menstrual bleeding~   "
147260|NCT01638910|"~     To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate~     and dienogest in healthy female subjects.~   "
147261|NCT01638897|"~     The purpose of this study is to evaluate long-term performance of the DF4 Connector System.~     This evaluation is based on the number of DF4 lead-related complications occurring during the~     study compared to the number of leads enrolled in the study. The DF4 systems will be followed~     for 5 years after implant. This study is required by FDA as a condition of approval of the~     DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance~     platform.~   "
147262|NCT01638884|"~     The purpose of this study is to investigate prospective merory (memory of intentions) in~     healthy controls and in aMCI (amnestic Mild Cognitive Impairment) and AD (Alzheimer Disease)~     patients.~   "
147263|NCT01638871|"~     The purpose of this study is to translate a proven pain coping skills intervention for~     osteoarthritis (OA) patients into an engaging and easy-to-use Internet-based intervention~     that uses innovative technologies to mimic traditional, in-person training sessions.~   "
147264|NCT01638858|"~     In this prospective, open-label clinical study is to investigate the behavior of the retinal~     functions during development of diabetic macular disease (DME) under the influence of~     Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used~     here as an objective criteria to information about the retinal function obtain.~   "
147265|NCT01638845|"~     INTRODUCTION: Hip Fracture is a public health problem because of its constantly increasing~     frequency and its high morbidity and mortality. The leading cause of death is cardiovascular~     decompensation, caused by painful phenomena associated with fracture and orthopedic~     surgery.With hip fracture, epidural local analgesia techniques have proven their benefit in~     mortality but are associated with numerous side effects that prevent routine use. Peripheral~     analgesic techniques locoregional the lumbar plexus, much safer, cause a decrease in~     postoperative pain after surgery for hip fracture and a decrease in mortality at 6 months.~     Elderly patients suffering from a hip fracture, no study has investigated the effect of local~     analgesia continuous femoral perineural catheter on the incidence of cardiovascular events in~     the perioperative period.~      OBJECTIVE: The main objective of this work is to show that perineural analgesia block~     continuous local anesthetic reduces the incidence of cardiovascular complications in the~     preoperative period of a patient with a hip fracture and fact, show that this technique~     decreases the incidence of mortality at one year of patients with a hip fracture (secondary~     objective).~      MATERIAL AND METHODS: This is a prospective, multicenter, randomized, descriptive type. It~     compares two populations of patients: one has a perineural analgesia by continuous infusion~     via a catheter of ropivacaine (n = 157) associated with a systemic analgesia and the other~     only systemic analgesia without development of a catheter perineural (n = 157). The duration~     of patient participation will be 12 months. In the first 24 hours after a hip fracture after~     randomization, study participants will benefit from the installation under strict asepsis, a~     continuous block by catheter, placed by an anesthesiologist experienced control room~     post-interventional. The local analgesia will be provided by continuous administration via~     the perineural catheter, ropivacaine for 5 days for the treated group. Except the local~     analgesia protocol, the protocols pre-and postoperative systemic analgesia and general~     anesthesia will be identical for all participants of the 2 groups, similar to techniques~     proposed in the context of everyday clinical practice, ensuring analgesia optimal for all~     patients in the study. The main features will be found three bioassays Troponin IC and 3~     electrocardiograms at the entrance to the hospital, J3 and J5 after inclusion. In addition,~     cardiovascular clinical monitoring and quantification of pain ( will be performed daily for 8~     days after inclusion. Finally, an assessment of higher functions by ladder MMS will be~     conducted at the entrance, J3, J5 and J8. Moreover, a survey of survival at 1 month, 3 months~     and 1 year will be realized.~   "
147266|NCT01638832|"~     This study will evaluate the association of non-alcoholic fatty liver disease and coronary~     artery disease. All patients presenting for coronary angiogram will receive the following~     examination:~        -  Transient Elastography and Controlled Attenuation Parameter using the FibroScan~        -  blood examination including biochemical markers The results of non-invasive liver~          steatosis and fibrosis measurement are compared with the results of coronary angiogram~          concerning the presence or absence of coronary artery disease.~   "
147267|NCT01638819|"~     Evaluate the efficacy of one infusion of stem cells from autologous umbilical cord blood in~     patients with autism over six months after infusion as measured by changes in expressive and~     receptive language.~      Also demonstrate improved behavior, learning, and changes in Serum tumor necrosis factor~     alpha (TNF-α), tumor necrosis factor beta (TNF-β), interleukin 1-alpha (IL-1α), interleukin~     1-beta (IL-1β), interleukin 6 (IL-6), interleukin 10 (IL-10), and interleukin 13 (IL-13).~   "
147268|NCT01638806|"~     Patients with acute myocardial infarction (AMI) are categorized according to the~     electrocardiogram (ECG) findings into: 1) patients with ST-Elevation Myocardial Infarction~     (STEMI), 2) patients with Bundle Branch Block Myocardial Infarction (BBBMI), and 3) remaining~     patients with so-called NON-ST-Elevation Myocardial Infarction (NONSTEMI).~      Patients with STEMI or BBBMI are treated with acute angioplasty (PPCI=primary percutaneous~     coronary intervention), and the sooner PPCI is performed the lower is the mortality. This is~     why prehospital diagnosis and field-triage of patients with STEMI directly to heart centers~     with PPCI facilities is recommended.~      In patients with NONSTEMI previous trials have indicated that early angioplasty, within 72~     hours of symptom onset, is associated with improved outcome when compared to late angioplasty~     or conservative therapy. No trials have so far been able to diagnose patients with NONSTEMI~     in the prehospital phase or immediately on arrival at a hospital, and triage them directly to~     PPCI. Implementation of point-of-care (POC) testing of biomarkers may enable prehospital or~     early inhospital establishment of the diagnosis NONSTEMI.~      The aim of the present trial is to identify patients with NONSTEMI in the prehospital phase~     or immediately on arrival at the local hospital based on a) symptoms, b) POC testing and c)~     ECG findings and then randomize patients to I) PPCI, or II) medical therapy and~     angiography/angioplasty within 72 hours (todays routine).~      Se below for detailed description~   "
147269|NCT01638793|"~     The present study is a randomized, prospective, single-blinded study. Patients presenting for~     colonoscopy under sedation will be included according to the statistical sample size~     calculation. Patients will be randomized to either group 1- capnographic monitoring or group~     2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia~     are documented and compared in both groups.~   "
147270|NCT01638780|"~     The main objective of the study is to investigate if resveratrol supplementation can improve~     overall and muscle-specific insulin sensitivity in type 2 diabetic patients.~      As a secondary objective the investigators want to investigate whether the improved insulin~     sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a~     reduced intrahepatic and cardiac lipid content.~   "
147271|NCT01638767|"~     Presently, a long protocol in an In Vitro Fertilization (IVF) cycle, patients need to take~     Marvelon, a drug that inhibits the follicular development at the beginning of the cycle in~     order to better control and also plan the onset of the ovary stimulation with gonadotropin.~      Marvelon is taken daily as soon as menstruation starts for a period of 14 to 21 days.~     Ideally, it has to be taken at the same time everyday and not be forgotten. This may cause~     higher stress level for some users. Presently on the market, there is a ring-shaped~     contraceptive device inserted in the vagina at day 1 of the cycle called NuvaRing. The~     purpose of this device is similar to an oral contraceptive. However, the benefit of NuvaRing~     is that it can be left in place for a period of up to 35 days without any other manipulation~     and keep an adequate rate of hormone for contraception. Moreover, NuvaRing shows better~     hormone stability in the blood. Although the side effects and the benefits are comparable for~     the two treatments, some studies have shown that more patients would respect the treatment~     with NuvaRing and that the level of satisfaction would be higher in women using NuvaRing when~     contraception is needed.~      The purpose of the study is to compare the rate of satisfaction as well as the level of~     stress in women using Marvelon daily or NuvaRing with single insertion in a long protocol.~     Moreover, this study allow us to verify if using NuvaRing, a vaginal contraceptive releasing~     constant daily doses for up to 35 days will allow us to facilitate the planning of In Vitro~     Fertilization cycles in long protocol.~   "
147272|NCT01638754|"~     Patients with heart failure and cardiomyopathy that have been referred for Cardiac~     Resynchronization Therapy (CRT) will have their CRT devices implanted using an image guided~     treatment plan for optimal lead delivery. The validation of image-guided CRT lead delivery~     will significantly advance the field of heart failure therapy.~   "
147278|NCT01638676|"~     The main purpose of this study is to evaluate the safety of Vemurafenib in combination with~     Metformin in melanoma patients. The phase II part of the study will also evaluate the~     clinical activity of the combined regiment. Based on pre-clinical studies and a phase I~     trial, the investigators hypothesize that the combination of an FDA-approved non-toxic dose~     of oral Metformin with Vemurafenib will yield little toxicity and improve clinical outcomes~     in terms of objective response rates and survival in metastatic melanoma patients.~   "
147279|NCT01638663|"~     The purpose of this study is to investigate the effect of tolvaptan on renal water, sodium~     and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure,~     pulse wave velocity (PWV) and augmentation index, basal and during inhibition of nitric oxide~     synthesis in healthy subjects.~   "
147280|NCT01638650|"~     This open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a~     modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients.~     Patients will receive Invirase 500 mg plus ritonavir 100 mg twice daily orally for the first~     week, followed by Invirase 1000 mg plus ritonavir 100 mg twice daily orally for the second~     week. The study treatment will be given in combination with two Nucleoside Reverse~     Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment~     guidelines. Anticipated time on study treatment is 14 days.~   "
147281|NCT01638637|"~     The objective of this study is to obtain female first-catch urine, vaginal, cervical and~     endocervical swabs and male first-catch urine and urethral swabs for testing with multiple~     APTIMA Assays on the Gen-Probe PANTHER® System~   "
147282|NCT01638624|"~     The release of tourniquet produces reactive oxygen species which can cause injury. Propofol~     is chemically similar to phenol-based free radical scavengers.~      Plasma total antioxidant capacity is a well-established marker of the overall protective~     effect of antioxidants in body fluids.The aim of the study is to investigate the effects of~     propofol on ischemia-reperfusion injury in total knee arthroplasty (TKA).~   "
147283|NCT01638611|"~     HIP2B is the stabilized form of the Human proIslet Peptide (HIP). Human proIslet Peptide is~     the human homolog of Islet Neogenesis Associated Protein (INGAP) peptide, which has shown~     signals of efficacy in type 1 and type 2 diabetes mellitus. In a mouse model of diabetes,~     repeat dose treatment with HIP results in new islet formation and improvement in blood~     glucose measurements.~      HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.~      The present clinical trial protocol proposes the first administration of HIP2B to humans with~     the goal of exploring the tolerability, safety and PK of HIP2B following subcutaneous single~     ascending doses.~   "
147284|NCT01638598|"~     Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after~     single rising doses (SRD) in healthy Asian male volunteers~   "
147285|NCT01638585|"~     In this randomized clinical trial (RCT) the investigators are trying to find out whether a~     low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum~     of 30 days is capable of prolonging the survival time without major amputation.~   "
147286|NCT01638572|"~     Well-regulated glycosylation is essential for the normal development of the nervous system.~     Altered expression of glycosyltransferases with resulting dysregulated glycosylation of~     neuroblastic cells might lead to the development of NB. The~     β1,4-N-acetylgalactosaminyltransferase III (B4GALNT3) exhibits GalNAc transferase activity to~     form the GalNAcβ1,4GlcNAc (LacdiNAc or LDN) structure. The Drosophila B4GALNTA, homolog of~     human B4GALNT3, has been suggested to regulate the neuronal development. By~     immunohistochemical studies, we demonstrated that the expression of B4GALNT3 correlated well~     with histological grade of differentiation in NB tumor samples. Since well differentiated~     tumors usually carry a better prognosis, we thus speculate that expression of B4GALNT3 in~     tumor tissues can a favorable prognostic factor of NB.~      To explore the role of B4GALNT3 in the prognosis of NB, we propose the following project with~     two specific aims:~      Aim Ⅰ: Establishing the significance of B4GALNT3 in the prognosis of NB: We plan to collect~     90 NB tumor samples, and evaluate the RNA and protein expression levels by Q-PCR, Western~     blot, and immunohistochemistry in the tumor samples. The results will be compared with the~     other clinicopathological and biological factors of NB. Also the expression levels of~     B4GALNT3 in tumor tissues will be correlated to the patients' outcome to clarify whether~     B4GALNT3 could be a prognosis marker of NB.~      Aim II: Clarifying the effects of B4GALNT3 on NB cell behavior in vitro and in vivo. For~     further strengthening the prognostic role of B4GALNT3 in NB, NB cell phenotype and behavior~     changes after overexpression or knock-down of B4GALNT3 are evaluated by in vitro assays as~     well as by a nude mice xenograft model.~      In summary, if our project can establish the role of B4GALNT3 expression in NB, we may~     further subclassify the NB patients, and give the NB patients more appropriate therapies to~     improve patients' outcome. Furthermore, B4GALNT3 could potentially serves as a therapeutic~     target in the future.~   "
147287|NCT01638559|"~     The primary objective of this study is to assess the efficacy of immunosuppression withdrawal~     (ISW) in pediatric liver transplant (tx) recipients.~   "
147288|NCT01638546|"~     This randomized phase II trial studies how well temozolomide with or without veliparib works~     in treating patients with small cell lung cancer that has returned or does not respond to~     treatment. Temozolomide works by damaging molecules inside the cancer cells, such as~     deoxyribonucleic acid (DNA), that are needed for cancer survival and growth. Veliparib may~     stop the growth of tumor cells by blocking proteins that are needed for repairing the damaged~     DNA and it may also help temozolomide to kill more cancer cells. It is not yet know whether~     temozolomide is more effective with or without veliparib in treating patients with relapsed~     or refractory small cell lung cancer.~   "
147289|NCT01638533|"~     This phase I trial studies the side effects and best dose of romidepsin in treating patients~     with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction.~     Romidepsin may stop the growth of cancer cells by entering the cancer cells and by blocking~     the activity of proteins that are important for the cancer's growth and survival.~   "
147290|NCT01638520|"~     New approaches are needed to achieve more rapid elimination of dormant mycobacteria and~     thereby shorten treatment for drug-sensitive and drug-resistant tuberculosis (TB). Dormant~     mycobacteria are relatively resistant to antibacterial drugs and approaches that enhance~     immune clearance have the potential to be more effective. Interleukin-4 (IL-4) is a key~     cytokine in the immune response to TB that may impair the clearance of mycobacteria. We~     hypothesize that pascolizumab, an anti-IL-4 monoclonal antibody, might be of value as an~     adjunct to standard treatment.~      The aims of this trial are to determine whether administration of pascolizumab as an adjunct~     to standard combination treatment for drug-sensitive TB produces changes in one or more~     parameters of bacterial or host response (including bacterial clearance, host clinical~     status, immune response, bacterial and host transcriptomics, lung imaging) that may indicate~     potential for enhanced sterilization and to confirm the safety of blocking IL-4 (previously~     demonstrated in healthy volunteers and patients with asthma) in patients with TB.~   "
147292|NCT01638494|"~     Calcium (Ca2+) and vitamin D (VitD) play an important role in child health. Aims. The~     investigators evaluated the daily intake of Ca2+ and VitD in healthy children; and the~     efficacy of Ca2+ and VitD supplementation. Daily Ca2 + and VitD intake was evaluated in~     consecutive healthy children through a validated questionnaire. Subjects with a daily Ca2 +~     and VitD intake < 70% of dietary reference intakes (DRIs) were invited to participate in~     prospective randomized trial with 2 groups of nutritional intervention: group 1, dietary~     counseling aiming to optimize daily Ca2+ and VitD intake plus administration of a~     commercially available Ca2 + and VitD supplementation product (Colecalcium®, Humana, Milan,~     Italy); group 2, dietary counseling alone. At the enrollment (T0) and after 4 months (T1)~     serum VitD levels were assessed.~   "
147293|NCT01638481|"~     The purpose of the study is to identify the inflammatory and coagulation pathways and~     mechanisms that are activated immediately following burn injury, and how they affect outcomes~     in terms of organ failure and death. This study also addresses the limitation of current~     tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in~     severely injured patients both in a comprehensive and rapid manner.~   "
147294|NCT01638468|"~     The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety,~     efficacy, adverse events and any new information that may surface regarding the use of the~     AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main~     pulmonary and lobar arteries ≥ 6mm in diameter.~   "
147295|NCT01638455|"~     Characterize Masimo noninvasive technology in spot check reading on subjects and make~     comparison to invasive blood sampling tested on reference analyzers.~   "
147296|NCT01638442|"~     The objectives of this study are to evaluate the safety and tolerability; and to determine~     the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.~   "
147297|NCT01638429|"~     The purpose of this study is to determine how certain types of bacteria in the human gut may~     affect weight gain, and contribute to the development of diabetes.~      The investigators initial studies have shown that gut bacteria that produce methane may~     directly affect weight gain. These bacteria, called methanogens, produce methane gas as a~     byproduct, which can be detected through breath testing. Methane can slow the passage of food~     through the intestines, which would allow extra time for uptake and absorption of nutrients~     and calories, and might contribute to weight gain. The investigators have also found that~     people who have increased levels of methane-producing bacteria in their intestines also have~     higher levels of glucose in their blood. Therefore, control of how the body responds to~     insulin and uses glucose may be altered in methane-producing individuals.~      This research study is designed to test the investigational use of the drugs neomycin and~     rifaximin that have been approved by the U.S Food and Drug Administration (FDA). While~     neomycin is FDA-approved for treating skin infections, preparing the bowel for surgery, and~     hepatic encephalopathy (a condition that occurs when a damaged liver cannot remove the toxins~     that a healthy liver normally would), and rifaximin is FDA-approved for treating travelers'~     diarrhea, they are not yet approved to be used together for the treatment of methanogens or~     obesity.~   "
147298|NCT01638416|"~     In Australia, blood for transfusion has a use by date of 42 days after collection. The~     actual age of blood given to patients depends on what is available at the time and the rate~     of usage. During the last decade, it has been reported that blood transfusion in patients~     admitted to intensive care was associated with an independent increase of mortality. Some~     research suggests that transfusion of fresher blood might help patients in the intensive care~     unit to reach a better recovery. This project will test whether patients who receive~     'fresher' blood do better than patients who receive 'standard issue' blood.~   "
147299|NCT01638403|"~     3. RATIONALE FOR BF2.649 IN NARCOLEPSY Narcolepsy is a disabling syndrome affecting the~     generation and organizations of sleep and wakefulness, first described by Westphal and~     Gelineau in 19th century. Excessive Daytime Sleepiness (EDS) and cataplexy are two main~     symptoms of narcolepsy. Other symptoms referred to as auxiliary symptoms are hypnagogic and~     hypnopompic hallucinations, sleep paralysis, dyssomnia and automatic behaviour. The~     prevalence of narcolepsy is estimated around 25 per 100 000 in Causasian population. It is~     often extremely incapacitating, interfering with every aspect of life, in work and social~     settings.~      Several breakthroughs in the understanding of physiopathology of narcolepsy have recently~     shown that most narcoleptic patients display a strongly decreased CSF level of orexins, a~     group of hypothalamic peptides with wake-promoting activity. It was also found that sporadic~     narcolepsy in dogs, mice and humans may also be related to a deficiency in the production of~     orexin ligands. Narcolepsy may be a neurodegenerative or autoimmune disorder resulting in a~     loss of hypothalamic neurons containing the orexin [Baumann CR & Bassetti CL Lancet Neurol.~     2005 ; Dauvilliers Y et al, Clin Neurophysiol. 2003 ].~      In accordance with guidelines published by the European task force [Billiard M et al, Eur J~     Neurol. 2006] , management of narcolepsy with or without cataplexy relies on several classes~     of drugs, namely stimulants for EDS, antidepressants for cataplexy and hypnosedative drugs~     for disturbed nocturnal sleep. The first line pharmacological treatment of EDS and~     irresistible episodes of sleep rely on Modafinil, 100-400 mg/day, given in two doses, one in~     the morning and one early in the afternoon, the need for amphetamines and amphetamine-like~     stimulants (e.g. methylphenidate) has been decreased. Sodium oxybate and antidepressants are~     main drug therapies of cataplexy.~      BF2.649, an H3R inverse agonist promotes significantly vigilance in mice knock out for the~     orexin gene, a reliable model of narcolepsy, whereas the animals remain calm, a difference~     with treatment by amphetamine-like drugs which induce psychomotor excitation. In addition,~     BF2.649 shows a significant inhibitory effect on the occurrence of narcolepsy episodes during~     the dark period. These narcolepsy episodes are to be compared to cataplexy episodes in human~     [Chemelli et al., Cell 1999] 11. In agreement, Modafinil, in humans, does not show any~     effects on cataplexy, even if it improves wakefulness by an ill-defined mechanism. Thus~     anticataplectic drugs, such as antidepressants, are given in addition to Modafinil to~     narcoleptic patients.~      Taken together, the preclinical and clinical results provide a compelling rationale for this~     study to verify and confirm, under randomized double-blind and placebo-controlled conditions,~     the safety and efficacy of escalating dose of BF2.649 in the treatment of EDS and cataplexy~     in narcolepsy.~      It is on the basis of preclinical studies, and on the observation of the first included~     patients, that the doses to be administered were determined.~   "
147300|NCT01638390|"~     The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl~     Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or~     elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.~   "
147301|NCT01638377|"~     This pilot study will explore the ways to link Ontario's remedial system for convicted~     drinking drivers to medical intervention, assess the receptiveness of the Back on Track~     client population to effective medical interventions, and assess the feasibility of a~     full-scale trial of pharmacotherapy for convicted drinking drivers.~   "
147302|NCT01638364|"~     The purpose of this study is to examine whether there is an increase in dopamine levels in~     the human striatum following an oral administration of alcohol, as has been evidenced in~     animal models. This will be a Positron Emission Tomography (PET) study using the radiotracer,~     [11C]-(+)-PHNO (11C]-( + )-4-propyl-~     3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol).~   "
147303|NCT01638351|"~     The purpose of this study is to investigate the effect of a 12-week progressive resistance~     training program on the skeletal muscle function, glycemic control, functional capacity, and~     quality of life in the elderly with type 2 diabetes mellitus.~   "
147304|NCT01638338|"~     The project aims to develop a new approach to risky drinkers by providing a facilitated~     website access and creating a local integrated support network.~      In order to do so:~      1) A non inferiority-randomised controlled study will be performed to test the hypothesis~     that: Brief intervention for risky drinkers delivered in primary care through facilitated~     access to an alcohol reduction website has non inferior outcomes to face to face brief~     intervention.~   "
147305|NCT01638325|"~     BC106 is a molecule that when injected with insulin lispro may change the speed of absorption~     of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin~     lispro and any side effects that might be associated with it, blood levels of insulin lispro~     after injection under the skin and how BC106 insulin lispro affects blood sugar after~     injection under the skin. There is a minimum 7 day washout between single doses.~   "
147306|NCT01638312|"~     The goal of this research is the attempt to implement a new research method based on modern~     electrochemistry successes, in particular the development of the polarographic method of~     fructose and fructose diphosphate identification and its implementation to detect the viral~     infection in early stage. There will be 20 samples from the HIV-infected patients and 30~     samples from the heath controls. The study will collect 10ml urine and examined fructose and~     fructose-diphosphate using the polarographic method.~   "
147309|NCT01638273|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.~      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.~      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption~     by Extending the Absorption Site.~      To overcome the shortcomings of the currently existing sustained release drug delivery~     technologies the investigators have recently developed a novel drug delivery system to enable~     a drug to be dissolved irrespective of the surrounding environment and further absorbed up to~     colon. The investigators coined this Geometrically Long Absorption Regulated System(GLARS).~   "
147310|NCT01638260|"~     - Rationale: Treatment with glucagon-like peptide 1 (GLP-1) has been shown to reduce plasma~     glucose levels to a further extent when added to standard therapy in type 2 diabetes~     mellitus. Given the well-known beneficial effects of GLP-1 analogues on glucose metabolism by~     stimulating insulin release, suppressing elevated glucagon levels, delaying gastric emptying~     and reducing food intake, it is anticipated that liraglutide developed by Novo Nordisk~     (Victoza®) also has beneficial effects in type 2 diabetes mellitus as has been proven by~     several trials. Type 2 diabetes mellitus is associated with obesity and sedentary lifestyle.~     Obesity occurs when energy intake exceeds energy expenditure (EE) over a period of time. It~     has been presumed that activity energy expenditure and daily energy expenditure are lower in~     most people in Western societies. Increasing non-exercise activity thermogenesis (NEAT),~     defined as all energy expended due to everyday activity, exclusive of volitional exercise,~     may be an effective way to maintain daily EE and combat overweight and obesity. One way to~     promote NEAT is to decrease the amount of time spent on sedentary behaviors (e.g. watching~     television).~      This leads us to hypothesize that adding NEAT to GLP-1 analogues in type 2 diabetes has an~     additive effect on glucose regulation, weight control and blood pressure. On the other hand,~     we hypothesize that a decrease in HbA1c, weight and blood pressure could add to an improved~     quality of life and less health care costs. Therefore, the primary purpose of this study is~     to determine the synergistic effect of liraglutide and activating lifestyle by increasing~     NEAT on glucose metabolism and weight. First line therapy of type 2 diabetes mellitus~     currently consists of lifestyle changes with metformin. When failure of this regime occurs,~     sulfonylurea derivates and/or thiazolidinediones can be added. One third of patients with~     type 2 diabetes mellitus fail with this regimen after 5 years of monotherapy, and nowadays~     GLP-1 analogues can be added to prevent deterioration of glycaemic control. However,~     comparison of this strategy with NEAT has not been performed and the synergistic effect of~     combination of GLP-1 with increasing NEAT has not been investigated. Treatment with GLP-1~     analogues in combination with NEAT could theoretically overcome all shortcomings of current~     treatment strategies of type 2 diabetes mellitus.~      Objective:~        -  Primary objectives~             -  To determine the change in HbA1c from baseline and end of treatment (26 weeks) and~               end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus~               liraglutide with NEAT~             -  To determine the change in weight from baseline and end of treatment (26 weeks) and~               end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus~               liraglutide with NEAT~        -  Secondary objectives~             -  To assess the change in blood pressure from baseline and end of treatment (26~               weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide~               versus liraglutide with NEAT~             -  To assess the change in quality of life from baseline and end of treatment (26~               weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide~               versus liraglutide with NEAT~             -  To assess the change in NEAT from baseline and end of treatment (26 weeks) and end~               of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus~               liraglutide with NEAT~             -  To asses the health-care related costs at baseline, after 26 weeks of treatment~               with liraglutide versus liraglutide with NEAT, and after 52 weeks (end of~               follow-up)~      Study design: Randomized controlled intervention study~      - Study population: Men and women with type 2 diabetes mellitus, insufficiënt glycaemic~     control during maximum (tolerable) dose monotherapy with metformin or a sulfonylurea derivate~     or during combination therapy with metformin and a sulfonylurea derivate or a~     thiazolinedione, HbA1c above 7,0%, age between 40 - 75 years old, BMI above 25 kg/m2~      Intervention: One group receives once daily subcutaneously liraglutide 1.8mg added to~     standard anti-diabetic care and the other group receives once daily subcutaneously~     liraglutide 1.8mg added to standard anti-diabetic care and an activating lifestyle by~     increasing NEAT~      Main study parameters/endpoints: The main study parameter is the percent change in HbA1c and~     weight. Secondary study parameters are change in blood pressure, quality of life as measured~     using EQ-5D and SF-36 questionnaire, NEAT as measured using an activPAL™ accelerometer and~     cost-effectiveness analysis.~   "
147311|NCT01638247|"~     A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or~     palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH~     analogue in male breast cancer patients (MALE).~   "
147312|NCT01638234|"~     Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin~     may aid sleep and also has anti-inflammatory properties, and has been suggested in managing~     sleep disturbance in AD patients. However, there has been no large randomized controlled~     trials. Hence the objective of this double-blind randomized controlled study is to determine~     whether supplementing melatonin is effective in improving sleep problems in children with AD.~   "
147313|NCT01638221|"~     This study will be comparing the patients overall satisfaction of two different meshes used~     in laparoscopic inguinal hernia repairs.~   "
147314|NCT01638208|"~     Aim~      To compare changes in gut microbiota of IBS patients and healthy controls using next~     generation sequencing method like Illumina sequencing based on 16S rDNA profiling.~      The major objectives of the study are:~      To characterize type of bacterial species and compare diversity of the host's gut microbiota~     in 20 Irritable bowel syndrome (IBS) patients with 16 healthy controls (HCs) using high~     through put culture-independent method like Illumina sequencing.~      To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8~     weeks.~      To study the improvement of symptoms after modulation of gut microbiota with probiotics (VSL~     #3) for more than 8 weeks.~   "
147315|NCT01638195|"~     This study is a prospective, single-institution trial wherein twenty subjects with refractory~     hypertension will receive the experimental focused ultrasound renal denervation therapy.~     Safety will be assessed by incidence and evaluation of serious adverse effects associated~     with the investigational procedure through 52-week evaluation of bilateral treatment.~     Clinical utility will also be evaluated by comparison pre and post therapy systolic and~     diastolic blood pressure and norepinephrine spillover.~   "
147316|NCT01638182|"~     The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins~     osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a~     nutritional dose range.~      The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to~     the RDA of vitamin K.~   "
147317|NCT01638169|"~     During the stand phase the DMD foot is too plantarflexed in addition patients adopt a higher~     flexion and abduction of the hip in order to advance the swinging limb. The aim of this work~     is to assess the immediate contribution of heels for these walking disturbance in children~     with muscular dystrophy disease.~   "
147318|NCT01638156|"~     This study will evaluate the importance of arterial stiffness and wave reflections as~     determinants of persistent left ventricular (LV) hypertrophy and fibrosis (assessed using~     cardiac magnetic resonance imaging [MRI]) after correction of severe stenosis of the aortic~     valve. The hypothesis will test whether stiff arteries and increased wave reflections impede~     pumping of blood by the LV after aortic valve replacement (AVR)and precent adequate~     regression (improvement) of hypertrophy and fibrosis of the myocardium despite correction of~     aortic valve stenosis.~   "
147319|NCT01638143|"~     The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7)~     after intake of three different vitamin K2 supplements.~   "
147320|NCT01638130|"~     The purpose of this study is to explore the experiences and needs of patients with a~     high-grade glioma and their caregivers. Semi-structured interviews with patients and~     caregivers will be conducted and analysed using Grounded-Theory approach.~   "
147321|NCT01638117|"~     The purpose of this study is to determine the cumulative irritation potential of the products~     listed by the Sponsor.~   "
147322|NCT01638104|"~     The purpose of this study was to investigate the safety and tolerability of ANX-042 when~     administered by continuous intravenous (IV) infusion in healthy volunteers.~   "
147323|NCT01638091|"~     Most colorectal cancers arise from polyps. Most polyps removed at colonoscopy are small. New~     technologies such as narrowband imaging (NBI) offer the possibility of in differentiation~     between precancerous and unimportant small polyps. Use of these technologies could decrease~     the costs and potentially the risks of screening and surveillance colonoscopy.~      Multiple studies have demonstrated the ability of experienced endoscopists to achieve high~     accuracy in differentiating polyp types using NBI.~      The investigators hypothesize that community-based endoscopists can learn to identify polyp~     type at colonoscopy with the aid of NBI through the use of an introductory didactic program,~     followed by practice based-learning, and that their experience can serve as guidelines for~     wider dissemination.~      The purpose of this study is to test an educational program combining a didactic program~     followed by practice-based learning that is designed to allow community-based endoscopists to~     become proficient at the use of NBI in the colon. This study will not affect the care of~     patients in any way. The research subjects will be the endoscopists, who will perform~     colonoscopy and polyp removal in the usual clinical fashion, with the addition of attempting~     to predict polyp type before resection.~   "
147324|NCT01638078|"~     Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated with~     restenosis in approximately 10% to 50% of cases.~      Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn~     delay healing and endothelialization and may lead to restenosis and atherosclerosis within~     the stented segments.~      The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory~     and antioncogenic properties that could be of benefit in case of PCI with stenting.~   "
147325|NCT01638065|"~     The objective of this study is to show VeinViewer® Vision is an effective vein visualization~     device for peripheral vascular access, pre-, during, and post access.~   "
147327|NCT01638039|"~     The aim of this study is to accelerate the development of vaccine candidates against~     diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan to~     identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study~     humoral and cellular immune parameters following natural infections with Shigella and ETEC,~     and to compare the level of pre-existing local, humoral and cellular immune parameters in~     cases of shigellosis and ETEC-associated diarrhea and in matched controls.~   "
147328|NCT01638026|"~     Study Objectives:~        1. To prove that the use of GnHR agonist for final oocyte maturation results in a higher~          percentage of mature oocytes than the use of hCG.~        2. To show an advantage in women's satisfaction in the proposed protocol versus the~          standard antagonist protocol In the study group women will receive GnRH agonist for~          oocyte maturation, followed by ovum pick-up which will be performed 35 hours later.~          Embryo transfer will be performed 48-72 hours after ovum pick-up. Luteal support will~          include HCG 1500 IU. Blood samples for BHCG, progesterone and estradiol will be obtained~          14 days after embryo transfer.~   "
147329|NCT01638013|"~     The purpose of this study is to evaluate the safety and efficacy of long-term administration~     of ASP015K in patients who have completed Phase IIb or Phase III studies.~   "
147330|NCT01638000|"~     The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50~     mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied~     with their treatment due to lack of efficacy.~   "
147331|NCT01637987|"~     The purpose of this study is to determine if the use of a vein identification assistive~     device increases nurse PIV insertion success within the first two attempts in children 0-12~     months of age when compared to unassisted methods.~   "
147332|NCT01637974|"~     The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine~     adhesions formation after any hysteroscopic surgery.~   "
147333|NCT01637961|"~     This phase II trial studies how well alisertib works in treating patients with leiomyosarcoma~     of the uterus that has come back or persistent. Alisertib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
147334|NCT01637948|"~     Traditional Chinese medicine (TCM) has been seen as the predominant way of treating disease~     in China over three thousand years. Certain TCM have scientifically proved to have~     anti-bacterial property. Patients having orthodontic treatment have higher risks of caries~     and gum diseases. The purpose of this study was to determine whether the use of TCM~     Mouthrinses in addition to toothbrushing and flossing has an added benefit for orthodontic~     patients in maintaining proper oral health.~   "
147335|NCT01637935|"~     To assess the potential association between pioglitazone and bladder cancer compared with~     non-pioglitazone users among patients with type 2 diabetes mellitus.~   "
147336|NCT01637922|"~     Otherwise healthy subjects who are currently bein maintained on either methadone or~     buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at~     least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs~     between BI 201335 and either methadone or buprenorphine/naloxone.~   "
147337|NCT01637909|"~     In hypertension, lifestyle modification has been proven to be effective in reducing blood~     pressure while decreasing the risk of cardiovascular disease. The dietary approaches to stop~     hypertension(DASH) diet, sodium restriction and exercise has been shown to reduce systolic~     blood pressure by 8-14mmHg, 2-8mmHg and 4-9mmHg, respectively. The DASH-sodium diet has been~     shown to have additional systolic blood pressure lowering effect of 7.2mmHg, which is equal~     to adding one antihypertensive drug. However, as the dietary pattern is different in the~     Korean population, the investigators cannot implement the data from Western countries~     directly to the Korean population. For example, the consumption of dairy products is much~     smaller in the Korean population when compared to the western population. Therefore, the~     effectiveness of DASH-sodium diet and exercise on blood pressure lowering in the Korean~     population is not well defined. In this study, the investigators sought to determine the~     effectiveness of the DASH-salt diet and DASH-salt diet plus exercise on brachial blood~     pressure lowering. The study will be performed on untreated prehypertension patients and~     uncontrolled hypertensive patients undergoing anti hypertensive treatment with blood pressure~     measured between 140-159mmHg/90-99mmHg at the time of enrollment.~   "
147338|NCT01637896|"~     The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting~     balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent~     implantation in terms of restenosis~   "
147339|NCT01637883|"~     To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal~     tube cuff for postoperative sore throat.~   "
147340|NCT01637870|"~     This study is aimed at determining whether or not the use of a wound suction device placed on~     the cesarean incision instead of a standard sterile dressing will decrease the prevalence of~     wound complications and wound infections in women at high risk for post operative~     complications. The study will first look at the infection and wound complication rate in~     women 6 months prior to the start date of the study by reviewing charts of women who have~     undergone a cesarean section. The study involves placing a single use, portable wound vacuum~     over the cesarean section incision and keeping it in place for 72h. The investigators will~     then compare the rates of wound infection and wound complications between these two groups.~      It is our hypothesis that negative pressure wound systems will decrease the wound infection~     and complication rate in this high risk population.~   "
147341|NCT01637857|"~     Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal~     sphincter resting pressure. No studies have investigated a possible role of FH in anal~     fissures (AF). We aim to evaluate the effectiveness of a diet in curing AF and the clinical~     effects of a double-blind placebo controlled (DBPC) challenge with cow's milk protein or~     wheat.~   "
147342|NCT01637844|"~     Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen~     (HBeAg) have an increased risk of becoming infected with HBV. This study will determine~     whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive~     pregnant women during the third trimester, in addition to standard immunoprophylaxis in~     infants, will be more effective than standard immunoprophylaxis alone at preventing HBV~     infections in these infants.~   "
147343|NCT01637831|"~     The recent literature shows an increased incidence of obstructive sleep apnea (OSA) in~     patients with idiopathic pulmonary fibrosis (IPF). On the other hand there are no published~     studies related to CPAP treatment in this patient group. The investigators aim was to assess~     the effect of CPAP on sleep and overall life quality parameters in IPF patients with OSA and~     to recognize and overcome possible difficulties in CPAP initiation and acceptance by these~     patients.~   "
147344|NCT01637818|"~     Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh~     plug for inguinal hernia repair based on the following published study Randomized clinical~     trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg.~     2007 Jan;94(1):36-41.~      Primary endpoints is recurrence.~   "
147345|NCT01637805|"~     The purpose of this study is to evaluate the clinical safety and preliminary efficacy of~     antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant~     adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.~   "
147346|NCT01637792|"~     The purpose of this study was to explore the impacts of different continuous ambulatory~     peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges~     CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in~     incident Chinese peritoneal dialysis patients.~   "
147347|NCT01637779|"~     There is no effect of a parent-directed fact sheet about pain management during childhood~     immunization and pre-test on parent learning about evidence-based pain relieving methods.~   "
147348|NCT01637766|"~     Metastatic malignant tumors comprise the vast majority of spinal tumors in adults. The most~     devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal~     and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a~     clinical entity known as cord compression that manifests with progressive loss of motor~     function and sensation in the legs, as well as bladder and bowel incontinence.~      The treatment of spinal metastases is mostly palliative with the goals of improving or~     maintaining neurologic function, achieving local tumor control, and spinal stability. Most~     patients with spinal metastatic disease are currently treated effectively with radiation~     therapy and/or surgery with good results. There are however certain limitations in the~     current treatment of SMD. Radiation therapy has two important limitations: 1) if the targeted~     SMD is in close proximity the spinal cord, delivery of high radiation doses is~     contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and~     2) there is limit on the cumulative amount of radiation dose, which means that recurrent~     tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned,~     the main limitation is that some patients are not fit for surgery because of medical~     co-morbidities.~      This phase I clinical research trial will test the hypothesis that a new minimally invasive~     treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients~     with SMD.~   "
147349|NCT01637753|"~     The purpose of the study is to determine the safety and efficacy of intracranially implanted~     Carmustine in the treatment of patients with recurrent malignant glioma.~   "
147350|NCT01637740|"~     A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic.~     Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR LS~     900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with~     those of cataract myopic eyes group without pseudoexfoliation syndrome.~   "
147351|NCT01637727|"~     The primary goal of this proposed research deals with estimating the risk of developing type~     2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a~     history of GDM. In addition, this study will attempt to evaluate the effect of parity on the~     late appearance of type 2 diabetes and metabolic syndrome in this unique population.~   "
147352|NCT01637714|"~     The investigators will evaluate the efficacy of multi-strain probiotics in adults with~     diarrhea predominant irritable bowel syndrome.~   "
147353|NCT01637701|"~     The goal of this study is to compare the perioperative and postoperative characters of~     plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients~     with large prostate.~   "
147354|NCT01637688|"~     The purpose of this study is to determine growth and protein status of infants with cow's~     milk protein allergy and treated with a newly innovated amino acid formula compared to those~     with a commercial amino acid formula.~   "
147355|NCT01637675|"~     Sodium tanshinone IIA sulfonate (STS) is a water-soluble derivative of tanshinone IIA~     isolated as the main pharmacologically active natural compound from a traditional Chinese~     herbal medicine,the dried root of Salvia miltiorrhiza Bunge known as Danshen. Danshen has~     been known for the function of improving body functions such as activating blood circulation~     and removing blood stasis according to the theory of traditional Chinese medicine. Danshen~     and its various formula products including STS have been long-time widely used in oriental~     countries, especially China to treat various inflammatory and cardiovascular diseases for its~     pharmacological actions, including vasodilatation, anticoagulation, anti-inflammation, and~     free radical scavenging,with negligible adverse effects observed.~      The investigator's objective is to evaluate whether STS exhibits beneficial effects on~     pulmonary hypertension. This is a randomized, controlled, multicentre clinical trial study.~     90 patients with pulmonary hypertension will be enrolled in this study.~   "
147356|NCT01637662|"~     To investigate headache score and accompanying symptoms during and after infusion of the~     natriuretic peptides.~   "
147357|NCT01637649|"~     -  This study attempts to elucidate whether stroke patients with dysphagia have reduced~          diaphragm movement during voluntary coughing, and also during deep inspiration and~          expiration than stroke patients without dysphagia.~        -  This study will also compare various spirometric measurements with the diaphragmatic~          motions.~   "
147370|NCT01637480|"~     The purpose of this study is to determined if a lower back treatment would change the hip and~     knee muscle activities in people with and without anterior knee pain. The investigators~     hypothesized that the lower back treatment may change the hip and knee muscle activities in~     people with anterior knee pain but not in people without anterior knee pain.~   "
147358|NCT01637636|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of tasimelteon (including its breakdown product) in the blood when taken alone and in~     combination with either rifampin or ketoconazole.~      Cytochrome P450 3A4 is an important enzyme produced by the body to breakdown certain~     medications. In this study, the effect that this important enzyme has on tasimelteon is being~     studied by assessing the effect rifampin and ketoconazole have on tasimelteon and how they~     are broken down by your body. Rifampin is a known inducer of Cytochrome P450 3A4 enzyme~     meaning that it increases the activity of the enzyme. Ketoconazole is a known inhibitor of~     Cytochrome P450 3A4 enzyme meaning that it decreases the activity of the enzyme.~      In addition, the safety and tolerability of tasimelteon will also be assessed throughout the~     study.~   "
147359|NCT01637623|"~     The purpose of this study is to determine if two medicines (allopurinol and losartan) can~     influence heart and blood vessel health compared to placebo in patients with sleep apnea who~     are using continuous positive airway pressure (CPAP).~   "
147360|NCT01637610|"~     The investigators will test the hypothesis that in a preterm population with a gestational~     age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than~     conventional methods (speculum examination for combination of pooling, nitrazine and ferning)~     for the detection of Preterm Prelabour Rupture of Membranes (PROM).~   "
147361|NCT01637597|"~     This is an exploratory study in patients with locally advanced or metastatic Non-small cell~     lung cancer. Patients who are eligible to apply for Extended Access Program of crizotinib~     must have ALK translocation detected by RT-PCR, IHC or FISH analyses methods.~   "
147362|NCT01637584|"~     The overarching objectives of this study are: 1) To investigate the neurobiology of~     posttraumatic stress disorder (PTSD) during Rapid Eye Movement (REM) and Non-Rapid Eye~     Movement (NREM) sleep relative to wakefulness; 2) To identify the neurobiological~     underpinnings of sleep treatment response to prazosin or placebo during wakefulness, REM~     sleep, and NREM sleep in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) (~     veterans with PTSD; and 3) To explore pre-treatment brain activity patterns during~     wakefulness, REM sleep, and NREM sleep that predict sleep treatment response. We will also~     explore the stability of the Positron Emission Tomography (PET) signal by comparing pre- and~     post-placebo changes in brain glucose metabolism in non-responders. For non-PTSD veterans,~     the stability of the PET signal will be evaluated in a subsample of 6 veterans without PTSD~     who will repeat the PET imaging procedures 8 weeks after the initial PET series.~      The overarching hypothesis is that PTSD is characterized by neurobiological alterations in~     the amygdala, medial prefrontal cortex (mPFC), and brain centers involved in the regulation~     of NREM and REM sleep, and that these neurobiological changes are normalized with effective~     sleep treatment.~   "
147363|NCT01637571|"~     The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP)~     related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would~     like to test its effectiveness in treating NCCP.~      The patient will undergo esophageal balloon distention testing (EBDT) before and after taking~     the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical~     properties of the esophagus. A catheter with a deflated balloon is placed through the mouth~     and into the esophagus and the balloon is inflated with water. ECG and labs will be done~     throughout the study as a measurement of safety.~   "
147364|NCT01637558|"~     The aims of this project are to:~        1. To evaluate the pharmacokinetics of first line antituberculosis drugs (isoniazid,~          rifampicin, pyrazinamide and ethambutol) when applying the 2010 WHO/IUATLD dosing~          guidelines across pediatric populations (0-12 years of age, HIV infected and uninfected,~          and with varied nutritional status) in Cape Town, South Africa and Blantyre, Malawi.~        2. To evaluate an 8-hourly weight band-based dosing strategy for lopinavir/ritonavir using~          the commercially available lopinavir/ritonavir (4:1 ratio) in children in South Africa~          receiving rifampicin-based antituberculosis treatment.~        3. To evaluate the pharmacokinetics of nevirapine in children in Malawi receiving~          rifampicin-based antituberculosis treatment.~   "
147365|NCT01637545|"~     Postoperative nausea and vomiting (PONV) is one of the most common and distressing~     complications after anaesthesia and surgery, and may lead to serious postoperative~     complications This prospective, randomized study designed to evaluate the best injection time~     to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3)~     antagonist in patients undergoing facial bone surgery.~   "
147366|NCT01637532|"~     The purpose of this interventional study is to determine the feasibility to combine standard~     chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy~     (Tocilizumab and Peg-Intron).~      This study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a monoclonal~     antibody against IL-6R (tocilizumab). High IL-6 levels correlate with poor prognosis and~     chemoresistance in ovarian cancer patients. In cases of chemoresistant ovarian cancer,~     therefore, modulation of the IL-6 pathway, by blocking the IL-6 receptor, may represent a~     promising strategy to both abolish drug resistance and amplify host immunity in patients with~     recurrent ovarian cancer. Blockade of the IL-6/IL-6R pathway may enhance immunogenic cell~     death and restore local normal DC maturation. In addition, the use of interferon-alpha~     (Peg-Intron) allows the full maturation of DC, thereby enhancing the anti-tumor response.~   "
147367|NCT01637519|"~     Kidney stones cause severe pain. Patients with a stone lodged in the ureter (the tube that~     drains the bladder), require urgent treatment with a stent to relieve the blockage. This~     tube, or ureteral stent, gives the patient relief until they can have their stone treated.~     This study is to evaluate a new type of ureteral stent to relieve pain from kidney stones.~     This stent is designed to drain the kidney and unlike other ureteral stents, is also designed~     to widen the ureter to help the stone pass on its own.~   "
147368|NCT01637506|"~     The purpose of this study is to add to the investigators' quest to understanding stone~     disease, by evaluating the metabolites excretion in urine and its relation to microflora~     present in the stool.~   "
147369|NCT01637493|"~     The purpose of this study is to examine the safety,tolerability,pharmacokinetics and~     pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.~   "
147371|NCT01637467|"~     Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using~     electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in~     people who are on bedrest due to critical illness in the intensive care unit. The purpose of~     this study is to determine the safety and feasibility of implementing EMS in critically ill~     patients who are on mechanical ventilation for greater than 7 days, and examine the effects~     of 4 weeks of EMS on leg muscle size, muscle strength and functional outcomes in these~     patients. The investigators hypothesize that EMS will be safe and feasible and that~     critically ill patients receiving EMS will show a smaller loss of muscle size and strength~     than those in the control group, who do not receive EMS.~   "
147372|NCT01637454|"~     Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal~     syndrome (HRS). However, there are very few studies on vasopressors in the management of type~     2 HRS. Terlipressin has been used commonly; however it is costly and not available in some~     countries. In the present study, the investigators evaluated safety and efficacy of~     terlipressin and noradrenaline in the treatment of type 2 HRS~   "
147373|NCT01637441|"~     The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent~     pathology in woman which can impair quality of life and generates pelvic, urinary or sexual~     functional disorders.~      It's considered that 8 % of women will be undergo surgery in this indication before the age~     of 80 years. Numerous surgical techniques have been described and we distinguish the~     interventions according to the route (vaginal or abdominal), and according to the use or not~     of synthetic mesh (non-absorbable) to increase the anatomical results.~   "
147374|NCT01637428|"~     The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device)~     will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to~     compression stockings which is the current gold standard of care.~   "
147375|NCT01637415|"~     Although there are several tools that can be used to evaluate the severity of ongoing alcohol~     withdrawal syndrome (AWS), there is no available tool that can predict which patients are at~     risk for developing AWS at the time admission, before the patient has developed AWS.~     Unfortunately, there are severe symptoms of alcohol withdrawal (e.g., seizures) which may~     develop early in the hospitalization, and before the development of other systemic symptoms~     which may warn medical personnel of the possibility of impeding alcohol withdrawal (e.g.,~     autonomic instability, delirium). The goal of this study is to evaluate the psychometric~     properties (e.g., predictive validity) of a new tool, the Prediction of Alcohol Withdrawal~     Severity Scale (PAWSS), on identifying which patients are at risk for developing complicated~     AWS (i.e., seizures, hallucinosis, delirium tremens) among hospitalized, medically ill~     patients.~   "
147376|NCT01637402|"~     The purpose of this study is to find out what effects, good and/or bad,an increased dose of~     Abiraterone Acetate in combination with prednisone has on patients and their prostate cancer.~     This study will investigate whether an increased-dose (2,000mg daily) is safe and potentially~     effective when given to patients whose cancer has grown while taking the standard dose.~   "
147377|NCT01637389|"~     Fundacion Cantaro Azul (FCA) is a non-profit organization in Baja California Sur, Mexico~     (BCS). Since 2006 FCA has piloted a safe drinking-water program in rural regions of BCS. The~     premise of their safe drinking-water programs has been the installation of household~     drinking-water disinfection systems which utilize an ultra-violet technology (UV) developed~     at the University of California, Berkeley. While the systems have been tested for safety and~     effectiveness at inactivating waterborne pathogens, FCA is interested in rigorously~     evaluating the impact of their safe drinking-water program at the population level. FCA is~     looking to expand their safe-water program during 2009 and 2010 to newly identified~     communities that lack safe-drinking water. In order to evaluate the community level~     effectiveness of their program FCA has agreed to randomize the timing of this expansion which~     will allow the lead investigators and key personal in this protocol to conduct a meaningful,~     scientific evaluation of the impact of their program through a randomized stepped wedge~     design.~      The research described in this protocol has four (4) primary objectives:~        1. To evaluate the impact the implementation of the safe drinking-water programs has on~          rates of gastrointestinal events in rural BCS communities;~        2. To evaluate the impact of the safe drinking-water programs on concentrations of fecal~          contamination in household drinking-water in rural BCS communities;~        3. To evaluate other-health and non-water impacts on communities where the safe-water~          programs are implemented, including school and work absenteeism, and health care costs;~        4. To identify household, program and system design characteristics that affect user~          compliance with the disinfection strategies.~      The investigators hypothesize that households that receive an UV based drinking-water~     disinfection system through the safe-water program will have reduced prevalence of~     gastrointestinal illness, and reductions in fecal contamination of household drinking-water,~     measured as concentrations of Escherichia Coli per 100 ml of water. Similarly, the~     investigators hypothesize that these communities will also have reduced health care costs,~     and school and work absenteeism due to the implementation of the safe drinking-water~     programs. The investigators further hypothesize that household level characteristics and~     specific program characteristics will differentially impact user compliance, measured as the~     sustained use of the systems over the course of the study. In order to evaluate the last~     hypothesis (Objective 4) two program variations will be rolled out to inform future~     programmatic decisions. A priori the investigators do not anticipate that these program~     variations will impact population measures for Objectives 1 and 2, but the investigators will~     explore these assumptions during analysis.~   "
147378|NCT01637376|"~     The purpose of this study is to evaluate the safety of I-PDT with Temoporfin for patients~     with Non-Resectable Non-Small-Cell Lung Cancer (NR-NSCLC). Several clinical studies suggested~     that photodynamic therapy (PDT) may be an effective treatment for patients with NR-NSCLC. PDT~     is a therapy where an external light source, such as laser, is used to activate a~     light-sensitive medicine to produce byproducts that can destroy cancer cells. In this study~     the investigators will use an experimental light sensitive medicine, Temoporfin, to perform~     interstitial PDT (I-PDT). In I-PDT, laser fibers are inserted into the tumor to activate the~     light-sensitive medicine.~   "
147379|NCT01637363|"~     In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick~     leave due to psychiatric sufferings. Mental health conditions are of great consequence not~     only to the sick-listed individual but also to his/her family and to society in general and~     in socioeconomic terms.~      The aim of this project is to systematically compare psychoeducation with the various~     standard offers to sick listed individuals with mental health conditions provided by job~     centers in four municipalities.~      Psychoeducation is employed within the psychiatric healthcare system and is defined as a~     group based treatment by means of educating participants about psychiatric conditions. In the~     present project, the employed psychoeducation focuses on psyche and work life, and its~     purpose is to impart knowledge about psychiatric conditions in order to provide the sick~     listed individuals with qualifications to understand, and, thereby, improve their own~     situation. Among others, there will be information about the symptoms of various psychiatric~     conditions, diagnoses, and treatment options. Furthermore, the participants will learn about~     specific, useful, cognitive tools in regards to the barriers and difficulties they might~     experience when reentering the work force and leave sickness absence behind.~      The project is designed as a randomized clinical trial in which the participants are offered~     either 1) psychoeducation as well as the standard offer to sick listed individuals provided~     by the municipality in which the individual lives or 2) the participants are offered merely~     the standard offer to sick listed individuals provided by the municipality.~      The target group consists of recently sick listed individuals with mental health issues -~     whether diagnosed or not. The individuals must be inhabitants of the municipalities of~     Struer, Lemvig, Skive, and Holstebro.~      The outcome measure is the determined as the duration of the sickness absence, the severity~     of the psychiatric condition, self-reported health, and `locus of control´. These outcome~     measurements are assessed at baseline and after 3 and 6 months.~   "
147417|NCT01636869|"~     Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot~     femoral nerve block and periarticular block, so we would like to know the plasma~     concentration of bupivacaine in these patients.~   "
147380|NCT01637350|"~     Different digestive tract reconstruction will affect the blood glucose level of gastric~     cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total~     gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which~     includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C~     -peptide and body weight of gastric cancer patients with type 2 diabetes.~   "
147381|NCT01637337|"~     To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in~     patients with >3cm renal pelvis stone.~   "
147382|NCT01637324|"~     Objectives~        1. To determine the impact of MSM-targeted multidisciplinary services on uptake of HIV~          voluntary counseling and testing (VCT)~        2. To determine the impact of MSM-targeted multidisciplinary services on the enrollment~          into care and retention of HIV-positive MSM~      Subject population: HIV-negative and HIV-positive MSM clients, age ≥18 years old, of the Thai~     Red Cross Anonymous Clinic (TRC-AC) in Bangkok Thailand, the Cipto Mangunkusumo Hospital in~     Jakarta, and the Sanglah Hospital in Bali, Indonesia~      Number of participants: 200 HIV-negative and 150 HIV-positive MSM participants~   "
147383|NCT01637311|"~     Achalasia is a rare esophageal motility disorder, which is characterized clinically by~     symptoms of dysphagia, regurgitation, weight loss and chest pain. With respect to long-term~     efficacy, Heller myotomy (HM) using an open or a laparoscopic approach has gained wide~     acceptance as the procedure of choice for the management of patients with primary achalasia~     in recent years. Although good or excellent long-term symptomatic response rates can be~     achieved in more than 90% of patients undergoing HM, recurrence or persistence of symptoms~     occurs in approximately 20%. Controversy exists regarding the therapy of patients with failed~     success after HM. Peroral endoscopic myotomy (POEM) has recently been described as a new~     minimally invasive endoscopic myotomy technique intending a permanent cure from primary~     achalasia. Our purpose was to evaluate the efficacy and the feasibility of POEM for patients~     with failed HM.~   "
147384|NCT01637298|"~     The goals of this application are to assess the usefulness of biomarkers, including p16~     proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV)~     types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying~     HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by~     anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it~     will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months,~     and perform HRA and biomarkers on all clients at baseline and every 12 months. Information~     from this study would inform AIN screening and follow up approaches in HIV-positive and~     HIV-negative MSM in both resource-limited and resource-rich settings.~   "
147385|NCT01637285|"~     The purpose of the study is to further evaluate the PK characteristics of PF-04856883.~   "
147386|NCT01637272|"~     multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide~     in patients with dumping syndrome~   "
147387|NCT01637259|"~     Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV.~     Antiretroviral therapy associated renal dysfunction has been predominantly described in terms~     of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur~     in the absence of significant reductions in eGFR. This substudy is an exploration of changes~     in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and~     safety of MVC as a switch for either nucleoside or nucleotide analogue reverse transcriptase~     inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with~     stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of~     combination antiretroviral therapy (cART).~   "
147388|NCT01637246|"~     This is a retrospective chart review and will assess changes in IOP after treatment with any~     fixed combination in patients who previously received monotherapy.~   "
147389|NCT01637233|"~     This substudy is a prospective, observational, open-label, randomised study within the MARCH~     study. The purpose of this substudy is to investigate the changes in cerebral function~     parameters at 5 timepoints over 96 weeks of the three different treatment arms within the~     MARCH study. The investigators hypothesise that there will be improvements in cerebral~     function in those patients randomised, as part of the parent study, into the maraviroc arms.~      the assessments in this CNS substudy will include:~        1. Neurocognitive function as assessed by a computerised testing battery called CogState;~        2. changes in cerebral metabolites as measured via 1H Magnetic Resonance Spectroscopy~          (1H-MRS)~      In those randomised to the maraviroc arms (arms 2 and 3) there is an optional Lumbar puncture~     at week 48. The cerebrospinal fluid will be used to measure maraviroc levels and an~     ultrasensitive CSF HIV-1 viral load. These results will be matched with levels in the plasma.~   "
147390|NCT01637220|"~     In about 10% of preoperative anaphylactic reactions to Neuro-Muscular Blocking Agents (NMBA)~     (114 patients analyzed at the BICHAT Hospital), a classical mechanism (mast cell- and~     IgE-dependent) is not identified. The mechanisms underlying these atypical anaphylactic~     reactions are unknown. The investigators have developed at the Pasteur Institute a murine~     model of anaphylaxis in which neutrophils, IgG and Platelet Activating Factor (PAF) play~     predominant roles. In addition, preliminary results obtained at the BICHAT Hospital suggest~     the presence of specific IgG anti-quaternary ammonium in the sera of patients that had~     developed a shock to NMBA anesthesia, but not in controls exposed to NMBA anesthesia or in~     normal blood donors. Finally, the release of neutrophil extracellular traps (NETs),~     extracellular filaments made of DNA and histones, may contribute to respiratory symptoms~     HYPOTHESIS: Neutrophils are implicated in NMBA -induced anaphylactic reactions in humans.~     Activated by IgG-NMBA complexes, which aggregate IgG receptors, neutrophils release PAF and~     NETs that are implicated in the cardiac and respiratory distress during anaphylaxis. It is~     possible that the activation of neutrophils: 1) explains the clinical features of atypical~     anaphylactic reactions (non-IgE mediated), 2) participates also in part to classical~     anaphylactic reactions GENERAL OBJECTIVE: Compare the percentage of circulating activated~     neutrophils in a group of patients immediately following a NMBA -induced shock (case) to that~     of a group of patients exposed to NMBA during anesthesia without developing a shock~     (control).~      SECONDARY OBJECTIVES:~      A) the day of the shock, quantify and compare between case and controls, 1) the level of~     circulating anti-quaternary ammonium IgG by immuno fluorometry, 2) the expression of IgG~     receptors (FcR) on the surface of neutrophils by cytometry, 3) the levels of circulating PAF~     by mass spectrometry, 4) the amount of NETs by immunofluorescence.~      B) 6 to 10 weeks after the shock perform, 1) cutaneous tests to NMBA, 2) a study of the~     capacity of stimulation of ex vivo neutrophils by IgG- NMBA complexes~   "
147521|NCT01635517|"~     The aims of the present study are to investigate prospectively the clinical course and~     outcome of the hospitalized heart failure patients treated with tolvaptan for management of~     fluid retention and serum sodium levels of less than 140 mEq/L and also to analyze the~     factors related with the efficacy including outcome of tolvaptan therapy.~   "
149150|NCT01614184|"~     The study goal is to develop a new method of intraoperative lymphatic mapping with~     fluorescent contrast agents to improve the outcome of therapeutic breast cancer surgery.~   "
147391|NCT01637207|"~     The Investigators aim to determine how easy it is for anaesthetists to identify the~     Cricothyroid membrane (CTM) in children and infants and whether ultrasound maybe useful in~     addition. The investigators aim to conduct a randomised single blinded trial to compare~     methods to detect the CTM.~      The first group of patients will be randomised to palpation of anatomical landmarks group.~     Prior to commencing the MRI scan the anaesthetist is timed to identify the CTM and then the~     trachea using a felt tip pen. A ficidual marker will be placed on the 2 marked areas.~      The second group of patients will be randomised to receive ultrasound. Prior to commencing~     the MRI scan the sonographer is timed to identify the CTM and then the trachea using a felt~     tip pen. A ficidual marker will be placed on the two marked areas.~   "
147392|NCT01637194|"~     This phase I trial studies the side effects and best dose of cetuximab when given together~     with everolimus in treating patients with metastatic or recurrent colon cancer or head and~     neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of~     tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus~     may be an effective treatment for colon cancer or head and neck cancer~   "
147393|NCT01637181|"~     A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA)~     techniques in patients with insufficiency of the great saphenous vein (GSV). There are~     multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode~     and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be~     equally effective in occluding the GSV. However, little is known about differences in~     patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial~     of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health~     related and varicose-specific questionnaires. The secondary outcomes are complications and~     effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower~     pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in~     complication rate and effectiveness between the two treatments.~   "
147394|NCT01637168|"~     The purpose of this study is to evaluate the efficacy and safety of two different drugs in~     the treatment of patients diagnosed with memory difficulties and a decline in cognitive~     function.~      This is a parallel distribution: a group of patients will be treated with a combination Panax~     Ginseng + Ginkgo Biloba + multivitamin + Polyminerals (EMS), and another group with Ginkgo~     Biloba (Tebonin ®).~   "
147395|NCT01637155|"~     Set the pattern of vitamin D supplementation in obese patients undergoing bariatric surgery~     in deficit of vitamin D.~      Patients receive a single oral dose of vitamin D, during the 28 days will be done a kinetic~     curve. Then and over the next 3 months, levels are normalized. Once normalized, will be~     administered another single oral dose to a second pharmacokinetic evaluation.~   "
147396|NCT01637142|"~     The purpose of this study is to assess the extent and rate of absorption of LY2140023 in~     healthy participants. The study has two periods. In Period 1, participants will receive a~     single oral dose of 80 mg LY2140023 followed by a 2-hour intravenous (IV) infusion of~     approximately 100 micrograms (µg) LY2140023 containing approximately 100 nCi [14C]-LY2140023.~     In Period 2, participants will receive an oral dose of 80 mg LY2140023 followed by a 2-hour~     IV infusion of approximately 100 µg LY404039 containing approximately 100 nCi [14C]-LY404039.~     There will be at least a 3-day washout between doses.~   "
147397|NCT01637129|"~     This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test~     tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal~     stroke.~   "
147398|NCT01637116|"~     The primary purpose of this study is to identify and characterize novel diagnostic markers~     for autoimmune urticaria, a subset of chronic spontaneous urticaria.~      Additional aims: include the comparison of the clinical profiles of autoreactive, autoimmune~     and non autoreactive / autoimmune urticaria and the quality of life impairment in these~     subsets of chronic spontaneous urticaria.~   "
147399|NCT01637103|"~     Depressive symptoms are highly frequent among cancer patients. These symptoms significantly~     impair quality of life (e.g., hopelessness, greater risk of suicidal behaviours) and may even~     affect patients' prognosis (e.g., through decreased adherence to cancer treatments).~     Cognitive therapy (CT) is an established treatment for depression in the general population,~     but its efficacy has not yet been investigated in non-metastatic cancer patients.~     Furthermore, because the accessibility to CT is very limited in routine cancer care and~     because many patients are reluctant to use pharmacological treatment, they often turn to~     alternative treatments such as bright light therapy (BLT), but empirical data on its efficacy~     are needed before its use can be recommended. Goal 1: To assess at post-treatment, as~     compared to a waiting-list control condition, the effect of bright light therapy (BLT) and~     cognitive therapy (CT): (1a) in reducing depressive symptoms; and (1b) in improving~     subjective and objective sleep parameters, in reducing fatigue and anxiety and in increasing~     patients' functioning and quality of life. Goal 2: To compare at post-treatment and at 3- and~     6-month follow-ups the effect of BLT and CT : (2a) in reducing depressive symptoms; and (2b)~     in improving subjective and objective parameters of sleep, in reducing fatigue and anxiety~     and in increasing patients' functioning and quality of life. It is hypothesized that, As~     compared to control patients after their waiting period, both BLT and CT groups will have~     significantly greater improvement of all symptoms at post-treatment. However, as compared to~     BLT patients, CT patients will show greater improvements of all symptoms at post-treatment~     and at 3- and 6-month follow-ups. This study will provide empirical data on the efficacy of~     two approaches for treating depressive symptoms in cancer patients in order to better inform~     the scientific community, health care providers, and patients on the most effective~     depression treatments to implement in cancer care.~   "
147400|NCT01637090|"~     CTCL is a rare form of lymphoma of the skin. While early stages are usually confined to the~     skin, later stages may spread to blood, lymph nodes and other organs. At this point, patients~     usually require systemic chemo. This study will investigate the effect of everolimus as~     treatment for recurrent or refractory CTCL. Participation in this study will last as long as~     the study doctor believes disease has not gotten worse, and patients continue to tolerate the~     study medication for a maximum of 1 year. Once off the treatment, patients will be followed~     for two years.~   "
147401|NCT01637077|"~     This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in~     patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.~   "
147402|NCT01637064|"~     By creating a registry, physicians will have the opportunity to understand the clinical~     outcomes of Myositis patients treated with Acthar. Despite the availability of clinical~     exams, muscle biopsies, and other testing, it is surmised that there may be a more important~     classification of myositis that physicians are not diagnosing which could possibly lead to~     improper treatment due to inaccurate diagnosis. There may be several types of immune and~     inflammatory myositis (IIM) that do not fit well into the typical sub classifications of~     myositis.~   "
149349|NCT01611584|"~     The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant~     tissue.~   "
147403|NCT01637051|"~     In a prospective randomised study two uncemented tibial components with different~     polyethylene modularities (Trabecular Metal Technology (TMT) Zimmer NexGen® monobloc and TMT~     Zimmer NexGen® modular) used for total knee arthroplasty (TKA) is evaluated. Both tibial~     component coatings are designed to provide excellent condition for bone ingrowth.~      The differences between the two tibial components are evaluated by measurements of migration~     of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the~     adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry~     (DEXA).~   "
147404|NCT01637038|"~     The investigators are trying to evaluate the clinical effect of remote ischemic~     postconditioning on liver graft function and postoperative renal function in subjects~     undergoing living-donor liver transplantation.~   "
147405|NCT01637025|"~     The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help~     stop bleeding in participants undergoing open cardiac, intra-abdominal (including~     retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some~     countries marketed as Tabotamp®)~   "
147406|NCT01637012|"~     To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of~     percutaneous coronary interventions in patients with coronary heart disease.~   "
147407|NCT01636999|"~     Nitrous oxide (N2O) has been used for the treatment of labor pains for over 150 years. The~     longevity of its use in clinical practice can be attributed to its excellent safety profile,~     ease of administration, and familiarity of use among health-care providers. Sedara is a~     self-administered 50% N2O, 50% oxygen gas mixture with pain relieving and anxiety reducing~     properties recently available for use in the United States (US) to treat various painful~     clnical situations, including labor pains.~      In the US, epidural or intravenous administration of narcotic medications is one of the most~     common and frequently requested treatments for patients experiencing labor pains. Although~     generally considered safe, complications are common with epidurals, including fetal distress,~     low blood pressure in the mother, respiratory distress, and headache. In our hospital system,~     the use of the synthetic intravenous painkiller, Butorphanol, is a mainstay of treatment for~     labor pains. It too can have undesirable side effects in the mother, including low blood~     pressure and breathing problems.~      Because Sedara has until recently been unavailable in the US, studies comparing its efficacy~     with other agents for labor pain have been confined to Europe, predominantly in the United~     Kingdom. Several studies have investigated the efficacy of Sedara versus inhalation and~     intravenous anesthetics in various countries. We have obtained several Sedara devices for use~     in the West Penn Allegheny Health System (WPAHS) Department of Anesthesiology and would like~     to examine its efficacy in our target population of women experiencing pain during early~     labor.~      Hypothesis - Sedara will provide equivalent or superior pain relief among term, adult~     parturients in early labor (less than 5cm cervical dilation) compared to intravenous~     butorphanol.~      Primary aim - Compare Sedara versus butorphanol in a single-blinded randomized trial with the~     main outcome measure being reduction in labor pains at various time intervals.~      Our findings may be significant in terms of improving safety and efficacy of pain relief~     among women experienceing labor pains. Given that Sedara has not been previously studied in~     the US, the results may influence current obstetrical and pain management practices.~   "
147408|NCT01636986|"~     The purpose of this study was to evaluate the performance of a novel silicone hydrogel~     contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY~     ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact~     lens-related dryness symptoms.~   "
147409|NCT01636973|"~     A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes~     patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of~     oxygenation and protection of airway damage. However, there is a lack of study about the~     effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung~     ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation~     and respiratory mechanics during one-lung ventilation .~   "
147410|NCT01636960|"~     This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN~     alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after~     definitive surgical resection including complete lymphadenectomy. Participants on this study~     will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to~     receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit~     (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a~     weekly basis is safe and tolerated.~   "
147411|NCT01636947|"~     This is an efficacy and safety study to compare aprepitant with ondansetron for the~     prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy~     (MEC) in participants with solid tumors. MECs include a number of commonly used cancer~     chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based~     regimens.~      The primary hypothesis of this study is that the Aprepitant Regimen is superior to the~     Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting~     Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.~   "
147412|NCT01636934|"~     The goal of this clinical research study is to learn if minocycline can reduce the side~     effects reported by patients with NSCLC who are receiving chemoradiation therapy. In this~     study, minocycline will be compared to a placebo.~      Minocycline is an antibiotic that may help to reduce side effects of chemoradiation therapy.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
147413|NCT01636921|"~     The Phase II goal of this clinical research study is to find the efficacy of this combination~     assessed by tumor response and local progression failure.~   "
147414|NCT01636908|"~     The purpose of this study is to determine intratumoral concentration of kinase inhibitors~     upon 2 weeks of treatment in tumor tissue of patients.~   "
147415|NCT01636895|"~     The study has two components: component A is a cohort study to determine the in vivo efficacy~     of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and component~     B is a cross sectional study of women delivering at the study hospitals to assess the~     effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context~     of increasing SP resistance. Results of component A and B studies will be used to model the~     relationship between the prevalence of molecular markers of SP resistance, in vivo efficacy~     to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for routine~     monitoring effectiveness of SP-IPTp as part of ANC surveillance.~   "
147416|NCT01636882|"~     This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA~     007 trial. There may be patients who have benefitted from the study drug and who might~     benefit from further treatment. In order to accommodate those patients further treatment to~     complete 48 weeks of CVA21 intratumoral injections will be made available.~   "
155399|NCT01532141|"~     The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067~     pharmacokinetics in healthy subjects.~   "
147418|NCT01636856|"~     Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea.~     Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator,~     breathing exercise and nasal lavage. The objectives are study the effects of therapy on~     oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on~     snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative~     expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal~     exercises) will have more modifications compared to the control group.~   "
147419|NCT01636843|"~     This trial is conducted in Europe, North America and South America. The aim of this trial is~     to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared~     to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to~     patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate~     (MTX) while on a stable background of MTX therapy.~   "
147420|NCT01636830|"~     The objective of this study is to evaluate the incidence of gingival fissures according to~     the type of brush used, soft and medium.~   "
147421|NCT01636817|"~     This trial is conducted in Europe, North America and South America. The aim of this trial is~     to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared~     to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to~     patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa~     biologics and are on a stable background of methotrexate (MTX) therapy.~   "
147422|NCT01636804|"~     On April 2, 2012 the manufacturer of the Quicksite® and Quickflex® leads, St. Jude Medical,~     released a voluntary medical device advisory regarding these leads' potential for problems~     with the silicone insulation covering one end of the lead, where it meets another section of~     the lead which is coated with a different insulating material (polyurethane). There has been~     a voluntary suspension of sales of these leads.~      There are approximately 179,000 of the above leads implanted worldwide with an estimated~     101,000 leads currently in service (59,000 in US). There have been 39 confirmed cases of the~     conductor portion of the lead becoming exposed from the silicone insulation~     (externalization), and the rate of occurrence of this type of problem is conservatively~     estimated at less than one percent. However, a review done by St. Jude Medical of returned~     Quicksite® and Quickflex® leads and available X-ray and fluoroscopic (x-ray movie) images of~     patients with these leads (from 1,219 patients) revealed a higher rate of 3-4%. It is~     presumed that there are patients whose leads have not yet been affected by this problem, but~     whose leads may show signs of structural changes on x-ray or fluoroscopy. This study seeks to~     determine what structural changes may be occurring in these leads, what signs might predict~     these changes, and what impact these changes may have on the lead and its performance.~   "
147423|NCT01636791|"~     Background: Common mental illness, such as anxiety disorders and depression, is the main~     cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be~     effective in alleviating target symptoms of these disorders, but its effect on sick leave~     rates has not been sufficiently addressed. The investigators have developed an intervention~     called return to work (RTW), which is based in cognitive behavioral theory, that has a~     primary aim of helping sick-listed patients with common mental illness return to work. This~     new treatment has not been evaluated in a randomized controlled trial.~      Aims: The aim of this study is to investigate the effect of CBT and RTW for common mental~     illness in a randomized controlled trial conducted in primary care. Participants will be~     randomized to diagnosis specific CBT (n=70), RTW (n=70), or a combination of the two~     treatments (n=70). Main outcomes are days of sick leave and clinician severity rating of~     psychiatric symptoms. This study could contribute to new knowledge regarding how to best~     treat patients on sick leave with common mental illness.~   "
147424|NCT01636778|"~     The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts~     in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count <80,000~     /μL, suggestive of compensated cirrhosis) to a level desirable to initiate antiviral therapy~     and to assess the ability of SB-497115-GR to maintain platelet counts at a level sufficient~     to minimise dose reductions of pegylated interferon (Peg-IFN) and ribavirin (RBV) therapy~     with the expectation that a lower rate of Peg-IFN dose reduction and omission will translate~     to a higher rate of sustained viral response.~   "
147425|NCT01636765|"~     This is a study to evaluate inter- and intra-rater reliability of the Clinician Erythema~     Assessment Scale. There is no treatment (intervention) associated with this study.~   "
147426|NCT01636752|"~     Care for people suffering from depressive symptoms should be given in a step-wise approach.~     One first step can be the provision of self-help material. Online self-help is an innovative~     way of providing self-help. The investigators want to study the effect of an interactive~     online self-help-program (Deprexis) in the treatment of mild to moderate depressive symptoms.~     Participants will be randomised to either twelve weeks of online-self help or a waiting-list~     control. Symptoms of depression and other aspects will be assessed over a one year period.~     Thereafter the controls will also receive online-self help. The investigators hypothesise~     that online self-help is superior to the control condition in alleviating depressive symptoms~     and preventing full blown depression.~   "
147427|NCT01636739|"~     This study aims to determine the incidence of intussusceptions (IS) (including suspected~     cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in~     Japan.~   "
147428|NCT01636726|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Work~     Package 2 and Workgroup 1. Primary aim of these studies is to develop, test and disseminate~     methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE)~     studies applicable to different safety issues and using different data sources. To achieve~     this, results from PE studies on five key adverse events (AEs) performed in different~     databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the~     studies in this protocol and not on the clinical consequences of the association under~     investigation .~      Asthma and chronic obstructive pulmonary disease (COPD) are the most common chronic airway~     diseases in the western world. For both, a stepwise treatment to reduce symptoms, improve~     lung function, and prevent risk of exacerbation is recommended using several drug classes~     according to guidelines published by e.g. the Global Initiative for Asthma [GINA guideline]~     and the Global Initiative for Chronic Obstructive Lung Disease [GOLD guideline],~     respectively. Beta-2-adrenoceptor agonists (B2A) are therapeutic mainstays in treating asthma~     and COPD due to their bronchodilative effects mediated by B2A. This drug class consists of~     two types of drugs: short acting B2A (SABA) which are used as a reliever medication and long~     acting B2A (LABA) which are used as maintenance / controller medication. Formoterol and~     salmeterol are the most frequently used LABA compounds with a half-life between 5-15 hrs and~     therefore, these compounds most commonly have labelled indications for use twice a day. .~      Focussing on cardiac side effects of B2A one must consider that drugs with an opposite~     mechanism of action (beta-adrenoceptor-antagonists) have well-known cardio protective effects~     and are widely used in patients suffering from e.g. ischemic heart disease, hypertension and~     acute myocardial infarction (AMI)). Conversely, stimulation of cardiac beta-adrenoceptors as~     done by B2A may have deleterious cardiovascular effects particularly in patients with cardiac~     risk factors. And in fact, tachycardia and arrhythmias are well-known side effects of B2A~     confirming a cardiac influence of these drugs particularly after oral therapy (due to a high~     systemic exposure) as stated in the respective summary of product characteristics (SPCs),~     e.g. clenbuterol (Spiropent(R)). Obviously, inhaled drugs cause much smaller systemic~     exposure but cardiac side effects (e.g. arrhythmias, tachycardia) are also described in the~     respective SPCs (e.g. formoterol [Foradil(R)). Furthermore, cardiac side were also reported~     after exposure with inhaled MA (e.g. ipratropium [Atrovent(R)].~      Several observational studies have been performed on the association between the usage of~     inhaled B2A and the occurrence of AMI. However, these studies have produced conflicting~     results. Reasons for this variation are numerous, e.g. small number of events (AMI) leading~     to poor precision of risk estimate, potential misclassification of potential cardiac events~     versus airway-related events due to similar clinical complaints, differences in populations~     of drug users, measurement of drug exposure, and background risk of AMI. Additionally, a~     consensus document was released in 2000, redefining AMI.~      To make comparing results possible, this protocol gives guidelines for conducting studies in~     the same way in five databases and across 3 designs (cohort, nested case-control,~     case-cross-over) on the association between inhaled LABA use and AMI. The main focus is to~     evaluate the impact of study design, population and database characteristics on the~     association between inhaled LABA and AMI.~      Data will be collected from the following databases: The Health Improvement Network (THIN),~     the General Practice Research Database (GPRD), the Dutch Mondriaan project, Base de Datos~     para la Investigación Farmacoepidemiológica en Atencion Primaria (BIFAP), the National~     Databases of Denmark, and the Bavarian statutory health insurance physicians' association~     database.~   "
147429|NCT01636713|"~     This is a 24-week, phase III multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study. The study will have 9 scheduled visits and a telephone contact~     Follow-up visit one week following the end of study treatment.~      The study primary endpoint is~      -Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169 Trough FEV1~     on Treatment Day 169 is defined as the mean of the FEV1 values obtained 23 and 24 hours after~     dosing on Treatment Day 168 (i.e. at the Week 24 visit).~      Secondary endpoints are;~        -  Mean TDI focal score at Week 24~        -  Weighted mean clinic visit FEV1 over 0 to 6 hours post-dose at Visit 2 (Day 1)~      Eligible subjects will be randomised to GSK573719/GW642444 125/25mcg, GSK573719/GW642444~     62.5/25mcg and placebo treatment groups in a 1:1:1 ratio such that of the planned 573 total~     number of randomised subjects, approximately 191 subjects will be randomised to each active~     treatment group and 191 subjects will be randomised to placebo. All treatments will be~     administered once daily in the morning by inhalation using a Novel Dry Powder Inhaler (NDPI).~      There will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects who~     meet the eligibility criteria at Screening (Visit.1) will complete a 7 to 14 day Run-In~     period followed by a 24-week Treatment period. Clinic visits will be at screening,~     Randomisation (Day1), Day2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after~     the Week 24 Visit (also referred as Treatment Day 169). A Follow-Up contact for adverse event~     assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early~     Withdrawal Visit. The total duration of subject participation, including Follow-up will be~     approximately 27 weeks. All subjects will be provided with albuterol/salbutamol for use on an~     as-needed basis throughout the Run-In and Study Treatment Periods.~      At screening, pre-bronchodilator spirometry will be performed followed by~     post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/FVC~     values will be used to determine subject eligibility. To further characterise bronchodilator~     responsiveness, post ipratropium testing will be conducted following completion of~     post-albuterol/salbutamol spirometry.~      Spirometry will be conducted at each post-randomisation clinic visit. Six hour post-dose~     serial spirometry will be conducted at Visit 2. Trough spirometry will be obtained 23 and 24~     hours after the previous day's dose of blinded study medication at Visits 3 to 9.~      Assessments of dyspnea will be obtained using the Baseline and Transition Dyspnoea Index~     (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnoea at~     baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change~     from baseline will be assessed using the TDI. Administration of the BDI and TDI should be~     done prior to spirometry and any other study-related procedures Disease specific health~     status will be evaluated using the St. George's Respiratory Questionnaire (SGRQ) and COPD~     Assessment Test (CAT), at baseline (Visit 2) and Visits 4, 6 and 8.~      The occurrence of adverse events will be evaluated throughout the study beginning at Visit 2.~     SAEs will be collected over the same time period as for AEs. However, any SAEs assessed as~     related to study participation (e.g., study treatment, protocol-mandated procedures, invasive~     tests, or change in existing therapy) or related to a GSK concomitant medication, will be~     recorded from the time a subject consents to participate in the study up to and including any~     follow up contact.~      Vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory~     tests (hematology and blood biochemistry) will be obtained at selected clinic visits.~      For determination of subject disposition, subjects will be considered to have completed the~     study, upon completion of Visit 9. There is no plan to provide any of the active study~     treatments for compassionate use following study completion.~      The Intent-to-Treat (ITT) population will be the primary population of interest, and is~     defined as all randomised subjects who have received at least one dose of the randomised~     study medication during the Treatment Period.~      Supplementary study conduct information not mandated to be present in this protocol is~     provided in the accompanying Study Procedures Manual (SPM). The SPM will provide the site~     personnel with administrative and detailed technical information that does not impact subject~     safety.~   "
147430|NCT01636700|"~     The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol~     infiltration or intravenous for tonsillectomy.~   "
147431|NCT01636687|"~     The purpose of this study is to demonstrate efficacy of autoinjector administered secukinumab~     at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to~     severe chronic plaque-type psoriasis.~   "
147542|NCT01635244|"~     The purpose of this study is to:~        1. Assess for hemodynamic differences at rest and with exercise between three clinically~          available tissue aortic valves.~        2. Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV~          hypertrophy, and changes in LV systolic and diastolic function) after aortic valve~          replacement for severe aortic stenosis (AS) between three clinically available aortic~          valve bioprosthesis.~   "
147432|NCT01636674|"~     The investigators are investigating the usefulness of 18F-Fluordeoxyglucose Positron Emission~     Tomography/ Computed Tomography (18F-FDG PET/CT) for staging and follow-up of colon cancer.~     Furthermore, the investigators combine 18F-FDG PET findings with clinical and~     histopathological features, circulating tumor cell (CTC) analyses, tumor gene expression and~     measurements of circulating cancer biomarkers sUPAR, TIMP-1 and CEA in order to predict tumor~     recurrence.~      The investigators hypothesis: The combination of functional imaging by 18F-FDG PET/CT and~     pre-existing and evolving molecular biomarkers will optimize tumor characterization, staging~     of disease and early detection of recurrence.~   "
147433|NCT01636661|"~     The primary objective of this proposal is to investigate the safety of use of transcranial~     Direct Current Stimulation (tDCS)in children with hemiparesis.~      The research question, Is transcranial Direct Current Stimulation safe for use in children~     with congenital hemiparesis? relates to two hypotheses:~        1. tDCS will not produce a major adverse event, including seizure activity.~        2. No change in paretic or nonparetic hand function or cognitive status will occur.~   "
147434|NCT01636648|"~     This was a prospective, non-randomized, multi-center, non-interventional post-market study.~     The study was a post-market long-term follow-up study based on the same cohort of patients~     (148 patients) enrolled in a previous investigational study from March 2007 to December 2009~     (ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005) involving 10 European sites.~     Patient follow-up took place on a yearly basis up to 10 years after the implant/enrollment.~     The primary objective of this study was to evaluate the safety and effectiveness of the~     Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.~      As this was an observational study, safety and efficacy data were summarized and described.~     There was no statistically powered study hypothesis.~   "
147435|NCT01636635|"~     The purpose of this study is to evaluate the effect of aging and weight loss on iron status~     and immune response in obese women. Iron deficiency and immune impairment are two of the~     numerous complications of obesity. The central hypothesis is that obesity-induced~     inflammation causes lower iron status through decreased iron absorption and availability in~     young and older obese women. Furthermore, the investigators hypothesize that this can be~     corrected with weight loss in both young and older obese women.~   "
147436|NCT01636622|"~     The goal of this clinical research study is to find the highest tolerable dose of vemurafenib~     that can be given in combination with carboplatin and paclitaxel patients with advanced~     cancer. The safety of the study drug combination will also be studied.~      Vemurafenib is designed to block a protein (called mutated BRAF) that is only found in moles~     (spots) of the skin and certain types of cancer cells. This drug may slow the growth of or~     kill these cells.~      Carboplatin is designed to slow the growth of cancer cells by stopping them from making new~     DNA (the genetic material of cells).~      Paclitaxel is designed to slow the growth of cancer cells by stopping them from dividing into~     new cells.~   "
147437|NCT01636609|"~     The goal of the Phase 1 part of this clinical research study is to learn the highest~     tolerable dose of cytarabine that can be given with tosedostat and the highest tolerable dose~     of 5-azacitidine that can be given with tosedostat to patients with AML or MDS.~      The goal of the Phase 2 part of the study is to learn if cytarabine with tosedostat and/or~     5-azacitidine with tosedostat can help to control the disease. The safety of these~     combinations will continue to be studied.~      Tosedostat is designed to block the production of proteins that cancer cells need to grow.~     Blocking these proteins may cause the cancer cells to die.~      Cytarabine is designed to insert itself into DNA (genetic material) of cancer cells and stop~     the DNA from repairing itself.~      5-azacitidine is designed to block certain proteins in cancer cells whose job is to stop the~     function of the tumor-fighting proteins. By blocking these proteins, the tumor-fighting genes~     may be able to work better.~   "
147438|NCT01636596|"~     The objectives of this project are to examine amyloid burden and cognition in a group of~     subjects diagnosed with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) before~     and after a six month course of insulin delivered weekly in a controlled pulsatile~     intravenous fashion in a clinical setting. The investigators central hypothesis is~     straightforward: The investigators predict that controlled pulsed IV infusion of insulin will~     improve cognition in patients with AD, and that this improvement will be correlated with a~     decrease in amyloid burden in these patients.~   "
147439|NCT01636583|"~     A water purifying system, called LifeStrawFamily (LSF), able to fortify water with zinc to a~     concentration of 4 mg/l has been developed. The aim of this study is to investigate whether~     the LSF strategy is advantageous in terms of zinc absorption compared to food fortification.~     This study wants to demonstrate whether aqueous zinc produced by the LSF device consumed~     within or outside meals is better absorbed than zinc from an enriched cereal-based staple~     food in healthy adults. In addition, the zinc absorption from the LSF-enriched water and from~     a fortified inhibitory cereal-based pudding will be compared.~   "
147440|NCT01636570|"~     The purpose of this study is to determine if treatment with vitamin D3 of 10,000~     International Units (IU) daily in vitamin D deficient patients for 6 months will improve B~     type natriuretic peptide (BNP), a marker of heart function, compared to placebo. The~     investigators also aim to determine if vitamin D helps cardiopulmonary function as evaluated~     by cardiopulmonary exercise test (CPX), laboratory values, strength, and quality of life in~     patients with stable congestive heart failure (Class II or III).~   "
147441|NCT01636557|"~     The main purpose of this study is to evaluate the potential effects of a single dose of~     sirukumab on the pharmacokinetics (what the body does to a drug) of study agents that are~     specific for cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, and CYP1A2) in patients~     with active rheumatoid arthritis (RA). This study will also assess the safety and~     tolerability of a single subcutaneous (SC, under the skin) dose of sirukumab in patients with~     active RA.~   "
147543|NCT01635231|"~     Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium-~     and water channels in the human kidney.~      Changes in the sodium-and water channel activity can be induced by blocking the sodium~     channels with diuretics in healthy subjects~   "
147544|NCT01635218|"~     The aim of this study was to determine whether individualized homeopathic treatment and~     fluoxetine are more efficient than placebo for moderate to severe depression in peri- and~     postmenopausal women.~   "
150434|NCT01597427|"~     The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary~     artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.~   "
147442|NCT01636544|"~     Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses.~     Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco~     consumption have been recognized for years as the main risk factors for development of OSCCs.~     However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or non-drinkers.~     Consequently, the hypothesis of another agent responsible has risen. Indeed, several studies~     have suggested the possibility that a virus could be associated with or be a causal agent of~     OSCC. The first objective is to detect and characterize the presence of infectious agent~     (mostly virus) transcripts in pre-malignant or malignant tumours from patients with OSCCs.The~     secondary objectives are (i) to associate and (ii) if possible define a causality link~     between these agents and a subset of potentially malignant disorders and/or OSCCs.~   "
147443|NCT01636531|"~     This multi-center, randomized, open-label, single-dose, parallel group study will assess the~     relative bioavailability, tolerability and dose-exposure relationship of a high concentration~     liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832)~     in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of~     either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.~   "
147444|NCT01636518|"~     Atrial Fibrillation (AF) is a form of rapid irregular heart rhythm that starts in the upper~     chambers of the heart (called atria) and is often associated with many health problems. It~     can cause stroke, palpitations and heart failure. The management of long standing (chronic)~     AF may require additional medications and blood thinners, potentially for life. It may also~     require procedures where the heart is shocked with an electrical current to restore normal~     rhythm. Some patients require a procedure called radiofrequency ablation to address the~     arrhythmia.~      The purpose of this registry is to collect information on patients undergoing this~     combination of procedures into a database, and to then use this information for scientific~     study to improve the treatment of atrial fibrillation.~   "
147445|NCT01636505|"~     The aim of this study is to performed a randomized controlled trial to evaluate the rate of~     genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and~     GnRH-antagonist ovarian stimulation protocols.~      Patients will be prospectively randomized in two groups: the first undergoing controlled~     ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist~     ovarian stimulation regimen.~      The end-points of the study include the number of genetically and chromosomally abnormal~     embryos, the pregnancy, the implantation and the healthy baby birth rate.~      The patients included in PGS program were selected on the base of advanced maternal age,~     repeated pregnancy lost and implantation failure whereas the patients who were know to carry~     sex-linked or monogenic disorders were considered for PGD strategy.~      The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the~     exclusion factors.~   "
147446|NCT01636492|"~     This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male~     volunteers. Subjects will be randomized in cohorts to receive single oral doses of either~     bitopertin or placebo.~   "
147447|NCT01636479|"~     Primary Objectives:~        -  To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the~          characterization of dose-limiting toxicities (DLTs).~        -  To assess biological activities in patients with dedifferentiated liposarcoma during MTD~          cohort expansion.~      Secondary Objectives:~        -  Pharmacokinetic (PK) profile of SAR405838.~        -  Biomarkers in association with SAR405838.~        -  Anti-tumor activity in response to SAR405838.~        -  Food effect on SAR405838 PK.~        -  Compliance with SAR405838 treatment.~        -  Cytochrome P450 3A4/5 (CYP3A4/5) activity.~   "
147448|NCT01636466|"~     The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®)~     in preventing antibody formation in patients with chronic failing kidney transplants.~     Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the~     prevention of rejection in kidney transplant.~      The primary objective for the study is to determine whether conversion of patients with~     chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent~     allosensitization. The secondary objective will be to determine whether conversion of~     patients with chronic renal graft failure to everolimus (elimination of calcineurin~     inhibitor) will delay the onset of dialysis.~   "
147449|NCT01636453|"~     To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive~     treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal~     carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent~     and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck,~     saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath~     and a delivery wire assembly. The implant component is made of superelastic and biocompatible~     nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial~     aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid~     terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating~     segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved~     embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a~     dome-to-neck ratio <2. Each patient will be followed and assessed for 2, 6 and 12 months~     after enrollment.~   "
147450|NCT01636440|"~     Conditioned pain modulation is the ability of the spine to describe changes in pain~     perception, if two different painful stimulations take place. The reliability of the~     conditioned pain modulation has not been studied, the instruments used to measure the~     conditioned pain modulation are sparse and have proven difficult to use in a well~     reproductible way. This study is using an existing pain test, relying on the reflex in a~     muscle after a painful electrical stimulation. We will test 34 healthy volunteers in order to~     test the reliability of the conditioned pain modulation with the nociceptive withdrawal~     reflex combined to a ice water test.~   "
147451|NCT01636427|"~     The purpose of this study is to assess differences in the risk profile and in the coronary~     angiographic presentation between STEMI and NSTEMI. Moreover possible relationship between~     myocardial infarction presentation and renal function will be investigated.~   "
147768|NCT01632293|"~     The purpose is to see how multiple sclerosis (MS) is associated with strength and sensation~     using MRI, in persons with MS. The investigators will also see whether exercise can improve~     these symptoms for persons with MS.~   "
147452|NCT01636414|"~     It is widely reported that a large percentage of total joint replacement patients receive~     allogeneic (human donor blood) blood transfusions due to perioperative blood loss with~     numbers ranging from 30% to 80%.~      The risks of allogenic blood transfusion are well documented in the literature. In addition,~     they are time-consuming: often lengthening hospital stay and decreasing the availability for~     postoperative physical therapy. Moreover, they are costly at several hundred dollars per~     unit, and allogeneic transfusions are linked with immunosuppression and increased~     postoperative infection rates and wound healing problems, which are devastating complications~     in this elective, joint replacement population. Several options are available for diminishing~     the need for allogenic blood transfusion following elective total joint replacement. These~     include the use of perioperative blood salvage devices (OrthoPAT) and tranexamic acid. While~     there is data to support the use of both OrthoPat and Tranexamic acid in primary total joint~     arthroplasty, there is little information comparing one versus the other in terms of efficacy~     and economics.~      The purpose of this study is to compare the safety, effectiveness and cost benefit of Hemovac~     drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total knee~     replacement surgery.~   "
147453|NCT01636401|"~     The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of~     aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic~     obstructive pulmonary disease (COPD).~   "
147454|NCT01636388|"~     The investigators intend to utilize reduced intensity conditioning and allogeneic stem cell~     transplant from EBV positive HLA matched sibling or unrelated adult donor combined with post~     AlloSCT allogeneic donor derived LMP specific cytotoxic T-lymphocyte (CTL) infusions in EBV~     positive patients with poor risk Hodgkin Lymphoma. One of three reduced intensity~     conditioning regimens predetermined at each institutional center of the Childhood, Adolescent~     and Young Adult Lymphoma Cell Therapy Consortium (LCTC) will be utilized for related or~     matched unrelated adult donor allogeneic transplant followed by donor LMP specific CTL~     infusion for three doses post AlloSCT. The investigators hypothesize that the addition of~     donor derived LMP specific CTLs will be safe and feasible.~   "
147455|NCT01636375|"~     This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the specific~     aims of this project are three-fold. First, the investigators intend to compare the amount of~     muscle atrophy and tendon damage that occurs around the hip between two commonly-used~     operative approaches: the direct-anterior approach and the posterior approach. Second, the~     investigators aim to provide baseline data on the amount of muscle atrophy and tendon damage~     that should reasonably be expected to occur with both of these approaches. Third, the~     investigators will document the degree of recovery of the periprosthetic soft tissues~     post-surgery in both patient groups.~      The investigators first hypothesis is that the posterior approach will demonstrate~     significantly more damage to the abductors, piriformis, and short external rotators than the~     direct anterior approach, which will demonstrate minimal soft tissue damage. The~     investigators second hypothesis is that both surgical approaches will cause some degree of~     baseline muscle damage and atrophy, in a predictable pattern. The investigators third~     hypothesis is that each of the surgical approaches inherently cause some degree of soft~     tissue damage, and that the periprosthetic soft tissues that are incised during the surgical~     exposure will recover in a predictable pattern which is consistent but unique within each~     group~   "
147456|NCT01636362|"~     Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total~     Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of~     the exclusion criteria and have given a signed and dated informed consent. Study site will be~     from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the~     burn is healed if that occurs earlier. All dressing changes will be performed at the clinic~     and gauze rolls will be used as secondary dressing. All dressing changes will be registered~     in a dressing log. All subjects will be consecutively allocated to a subject code.~   "
147457|NCT01636349|"~     The present study investigates the effects of recreational soccer in type 2 diabetic men in~     regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6~     month structured recreational soccer training and 10 men act as control with no change in~     lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans,~     echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting~     heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after 12~     and 24 weeks, respectively.~      The study examines the hypothesis that the high-intensity aerobic work profile combined with~     a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns,~     sudden stops) will improve glycaemic control, muscle and cardiac function and taken together~     will improve the overall health profile in type 2 diabetic men~   "
147458|NCT01636336|"~     The clinical studies propose to study the abuse-related effects of nicotine after~     progesterone administration during the follicular phase in women of reproductive age.~     Concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the~     role of the HPA axis in the abuse-related effects of nicotine.~   "
147459|NCT01636323|"~     The proposed clinical studies will evaluate the acute effects of nicotine on the~     hypothalamic-pituitary-gonadal axis in women to test the hypothesis that nicotine alters~     gonadal steroid hormones, and/or disrupts feedback regulation of ovarian hormones by anterior~     pituitary hormones.~   "
147460|NCT01636310|"~     The proposed clinical studies will analyze the interactions between nicotine, alterations in~     endocrine hormones, mood and cardiovascular measures. They also intend to examine the~     contribution of gender and menstrual cycle phase. These studies hypothesize that this novel~     focus on nicotine's rapid hormonal, cardiovascular and subjective effects will be important~     for developing novel biologic approaches to treatment for nicotine abuse and dependence as~     well as advancing our understanding of the neurobiology of nicotine reinforcement.~   "
147461|NCT01636297|"~     The purpose of this study is to gain a better understanding of how exercise training affects~     motor/hand function and brain function in those diagnosed with Parkinson's disease. The~     investigators want to study if exercise will improve hand function and improve the level of~     brain activity.~   "
147462|NCT01636284|"~     This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients~     with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with~     sorafenib, and the safe administration of JX-594 in five weekly IV infusions.~   "
147463|NCT01636271|"~     The overall objective of this integrated analysis is to evaluate the clinical safety and~     efficacy of long-term treatment with darapladib enteric coated tablets, 160mg, as compared to~     placebo when added to standard of care in subjects with clinical manifestations of~     cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome~     (ACS)). With respect to efficacy, the key purpose of this integrated analysis is to evaluate~     the effects of darapladib on the following endpoints: urgent coronary revascularization for~     myoacrdial ischemia, fatal/non-fatal stroke, time to subsequent Major Adverse Cardiovascular~     Event (MACE), and heart failure requiring hospitalization. The first occurrent of MACE, Major~     and total coronary events as well as the individual components of MACE will also be evaluated~     descriptively.~   "
147464|NCT01636258|"~     To examine whether a lifestyle program results in weight loss and thereby delays or prevents~     progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6~     weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants~     are randomized to receive all of the following: nutrition education, exercise instruction,~     stress management instruction, and culinary education or follow usual care. Outcomes include:~     blood sugars and cholesterol, weight, waist circumference, blood pressure, diet, physical~     activity, perceived stress, and class attendance. Analysis is by Intention to treat analysis~     of variance. Results will be used to help design larger randomized trial in the future.~   "
147465|NCT01636245|"~     The purpose of this study is to evaluate the immunogenicity and safety of three consecutive~     lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.~   "
147466|NCT01636232|"~     The higher rate of vitamin D deficiency is spotted among patients being hospitalized or in~     critical condition. Especially, vitamin D level below normal prolongs hospital stay and~     increases incidence of adverse prognosis and pushing up mortality of a number of diseases.~     However, it is remain unclear the relationship between vitamin D levels and critically ill,~     especially infection or sepsis. In this study, the investigators evaluate the significance of~     vitamin D for diagnosis and other relevant assessments of ICU cases, including vitamin D's~     relevance to sepsis, as well as its value in severity and prognosis assessment,~     high-performance liquid chromatography and tandem mass spectrometry was used to detect the~     quantification of the total 25(OH)D in serum of critically ill patients. The investigators~     speculate that measurement of vitamin D could be taken as an indicator for diagnosis and~     assessment in critically ill patients.~   "
147467|NCT01636219|"~     The major causes of morbidity and mortality in Cystic Fibrosis (CF) are linked to the process~     of chronic inflammatory of the airway, leading to the progressive damage of the small~     bronchioles and subsequently to the proximal bronchi. A connection between weaknesses of~     respiratory muscles in CF and deficits of CFTR in the muscle has been established.~     Insufficient cough in CF patients may advance re-current respiratory infections. A voluntary~     cough flow volume (C-FVC) profile incorporates the characteristics of the forced expiratory~     flow volume curve (FE-VC). The study aims to explore the correspondence of voluntary~     cough-flow-volume and maximum expiratory flow-volume maneuvers in relation to disease~     complications in CF patients.~   "
147468|NCT01636206|"~     The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution~     compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse~     events when administered BID for approximately 1 year.~   "
147469|NCT01636193|"~     This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect~     information regarding typical symptoms of intussusceptions and bloody stool in Japan.~   "
147470|NCT01636180|"~     REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg)~     administration in addition to high dose of clopidogrel continuous therapy (150 mg/day)~     results in higher inhibition of the platelets' aggregation in patients with myocardial~     infarction undergoing interventional treatment comparing to the standard therapy. Such~     treatment strategy will not cause increased risk of bleeding complications. In many trials~     treatment with to repeated loading doses of clopidogrel together with high dose of~     clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term~     therapy results, lower risk of ischemic complications. Currently, data regarding to the~     results of the above treatment are still limited.~   "
147471|NCT01636167|"~     To construct a computerized intraoperative keratometer to analyze the axis of corneal~     astigmatism accurately as well as rapidly by self-designed software during surgery.~   "
147472|NCT01636154|"~     The purpose of this study is to investigate the efficacy of fractions-based herbal~     combinations of clearing heat and promoting blood circulation treating acute ischemic stroke~     and the potential mechanism of it.~   "
147473|NCT01636141|"~     The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when~     given as a single dose and multidose to a defined area of one knee of healthy subjects.~   "
147474|NCT01636128|"~     The purpose of this study is to determine the effects of 2 drugs (sulindac and~     Difluoromethylornithine (DFMO)) either alone or in combination on biomarkers found in urine.~   "
147475|NCT01636115|"~     This study wants to understand which direction of shoulder movement and what posture of~     shoulder are best for the procedure of muscle strength testing of the muscle pectoralis~     major(PM). We will use muscle activity signals (sEMG) and force measurement to analyze the~     contribution of two parts of PM in three different contraction direction with three different~     shoulder postures.~   "
147476|NCT01636102|"~     To evaluate the safety of a single intramuscular (IM) injection of trivalent nonadjuvated~     influenza study vaccine, formulation 2012/2013, in adult and elderly subjects and the~     antibody response to each influenza vaccine antigen, as measured by single radial hemolysis~     (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult~     and elderly subjects in compliance with the requirements of the current EU recommendations~     for clinical trials related to yearly licensing of influenza vaccines.~   "
147477|NCT01636089|"~     The aim of this study is to compare bicarbonates versus saline for prevention of contrast~     induced acute kidney injury in critically ill patients.~   "
147478|NCT01636076|"~     To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to~     salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with~     COPD~   "
147781|NCT01632124|"~     Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab~     in patients with rheumatoid arthritis or inflammatory myositis.~   "
147479|NCT01636063|"~     Surgical abortion in the late first trimester and early second trimester is usually performed~     with the aid of a cervical preparing agent, which helps to open up the uterine cervix for the~     procedure. Routine use of cervical preparants is recommended by several organizations during~     this period of pregnancy before surgical abortion, especially in younger women or those who~     have not delivered a baby, because their cervices may be more difficult to dilate without a~     preparant.~      The standard medication used for cervical preparation is misoprostol. Unfortunately,~     misoprostol may cause uncomfortable uterine cramping and vaginal bleeding in patients who use~     it. Another medication called mifepristone has been shown to dilate the cervix better than~     misoprostol in the first trimester, but little information exists about using mifepristone in~     the late first trimester and early second trimester.~      The investigators plan to perform a prospective, double-blind, randomized trial to evaluate~     if mifepristone is a better cervical preparant than misoprostol. A total of 110 participants~     who are pregnant women desiring pregnancy termination 11 to 15 weeks gestational age will be~     recruited. Half will receive mifepristone and the other half misoprostol. The investigators~     will measure the amount of cervical dilation achieved right before a surgical abortion to~     determine if mifepristone is significantly different than misoprostol as a cervical preparant~     at this stage of pregnancy. The investigators expect that mifepristone will work better than~     misoprostol for this purpose.~      The investigators hope to generate information about mifepristone so that women and their~     health care providers can know more about mifepristone as an option for cervical preparation~     before surgical abortion.~   "
147480|NCT01636050|"~     The purpose of this study is to determine the effects of body mass-based squat training on~     body composition, muscular strength and motor fitness in adolescents.~   "
147481|NCT01636037|"~     Dopamine, a chemical in the brain, has been linked to schizophrenia for a number of years.~     More recently, there is evidence that certain areas affected in schizophrenia (e.g.~     motivation, cognition) may reflect too little dopamine, whereas symptoms like hallucinations~     and delusions have been linked to too much dopamine.~      This study is designed to evaluate the safety, tolerability, and efficacy of giving L-dopa~     (Sinemet) to see if it will improve those symptoms related to too little dopamine. L-dopa has~     been approved for other medical conditions (e.g. Parkinson's disease) and works to increase~     levels of dopamine.~      The investigators are linking this study with neuroimaging (fMRI) which will allows us to~     link any changes the investigators might find in clinical symptoms with changes in the brain.~     This information can prove useful in better understanding the mechanisms that account for~     these symptoms, as well as possible new treatments.~      At present , treatments for these other symptoms that seem important in functional measures~     of outcome (i.e. deficit symptoms, including amotivation; cognitive symptoms) in~     schizophrenia have not proven particularly effective. It is hoped that L-dopa may provide a~     treatment that is more effective; going forward, this information would also be useful in~     drug development and future lines of investigation.~        1. L-dopa will prove effective in improving deficit (also called 'primary negative' e.g.~          amotivation) and cognitive symptoms in schizophrenia.~        2. It will be well tolerated and not increase risk of psychotic symptoms when administered~          in conjunction with their regular antipsychotic medications.~   "
147482|NCT01636024|"~     The purpose of this study is to evaluate the safety profile and look at levels of AZD7594 and~     biomarkers in blood when the drug is administered inhaled to healthy subjects~   "
147483|NCT01636011|"~     The purpose of this study is to investigate the effect of selected Osteopathic Manipulative~     Medicine (OMM) techniques on the respiratory system of people with Parkinson's Disease (PD)~     in comparison to light touch. Effectiveness will be measured through pulmonary function~     tests, chest wall expansion, and voice analysis. Selected subjects will be randomly assigned~     to one of the two groups: OMM treatment group or light touch group. Although OMM treatment~     has been used on PD patients, a randomized controlled study has not been done to establish~     its effect on PD respiratory function. The authors believe that this study will show OMM's~     effectiveness.~   "
147484|NCT01635998|"~     The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in~     the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom~     a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF~     catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.~   "
147485|NCT01635985|"~     The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is~     administered in different ways - orally, intravenously or inhaled (with four different~     devices), to healthy subjects~   "
147486|NCT01635972|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of bupropion.~   "
147487|NCT01635959|"~     The purpose of this study is to calculate the prevalence of gastroesophageal reflux disease~     (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract symptoms~     in Egypt.~   "
147488|NCT01635946|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of atorvastatin.~   "
147489|NCT01635933|"~     The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared~     to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .~   "
147490|NCT01635920|"~     The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX®~     AQUA contact lenses.~   "
147491|NCT01635907|"~     This study is being conducted to evaluate whether the investigational drug Dovitinib, can~     shrink or slow the growth of cancer in patients with certain types of neuroendocrine tumors.~     This study will also further evaluate the safety of this drug.~   "
147492|NCT01635894|"~     The aims of the study were to attempt to answer the following questions; what proportion of~     women know how to and are able to exercise their pelvic floor and for those who cannot can~     they be trained and motivated to do so. This was a nested design comprising a prospective~     cohort study together with a controlled trial intervention after baseline assessment in the~     cohort study for a defined at-risk group.~   "
147493|NCT01635881|"~     To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA~     dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary~     arteries or bypass grafts.~   "
158911|NCT01486056|"~     This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG~     data.~   "
147494|NCT01635868|"~     Background Mesh repair reduces the risk of reoperation for recurrence in patients with small~     umbilical and epigastric hernias compared with sutured repair. However, reoperation for~     recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement~     may induce chronic pain. This study investigated the cumulated risk of recurrence after open~     mesh and sutured repair in small (≤2 cm) umbilical and epigastric hernias. Possible risk~     factors were evaluated for chronic pain and recurrence.~      Methods A cohort study with questionnaire-follow-up was conducted. Patients with primary,~     elective, open mesh or sutured repair for a small umbilical or epigastric hernia (≤2 cm) were~     included. Follow-up was performed by a validated questionnaire regarding suspicion of~     recurrence and chronic pain (moderate or severe). Suspected recurrence qualified for clinical~     examination. Recurrence was defined as reoperation for recurrence or clinical recurrence.~     Risk factors for recurrence and chronic pain were investigated by multivariate analyses.~      Results~      1 313 patients completed the questionnaire and/or clinical follow-up (83 % response rate) and~     follow-up time was median 40 months (range 0-66 months). The total cumulated recurrence rate~     55 months after primary repair was 10 % for mesh repair and 21 % for sutured repair~     (P=0.001). The incidence of chronic pain was 6 % after mesh repair and 5 % after sutured~     repair (P = 0.711). Recurrence was the only independent risk factor for chronic pain~     (P<0.001).~      Conclusion Mesh repair halved the long-term risk of recurrence after repair for small~     umbilical and epigastric hernias without increased risk of chronic pain.~   "
147495|NCT01635855|"~     A prospective, open-label 1-month post-approval study to evaluate the short term safety of~     Belotero® Balance in the re-treatment of nasolabial folds.~   "
147496|NCT01635842|"~     To understand the patients' meaning of the informed consent process in clinical trials.~      Objective of the study is:~        -  to assess, in a cohort of subjects included in clinical trials, whether the information~          and the informed Consent Forms conveyed to the patients have been understood~        -  to assess whether the choice to participate in a clinical trial is informed and aware~   "
147497|NCT01635829|"~     The purpose of this study is to investigate the potential pharmacokinetic (what the body does~     to the drug) interactions between multiple doses of phenytoin 200 mg every 12 hours or~     carbamazepine 200 mg every 12 hours and telaprevir 750 mg every 8 hours at steady-state~     (constant concentration of medication in the blood) in healthy participants.~   "
147498|NCT01635816|"~     The proposed Japanese Encephalitis (JE)Vaccine study is a four-arm double-blind randomized~     controlled single center trial to evaluate, by examining post-vaccination seroprotection~     titers, the lot-to-lot consistency of three lots of JE live attenuated SA 14-14-2 vaccine~     manufactured in a new GMP facility, and to establish non-inferiority of the new vaccine in~     comparison to a single lot of the same vaccine manufactured in the existing facility. The~     study will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to~     providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA~     14-14-2 vaccine among Bangladeshi children. This will be the first step to secure licensure~     for this life-saving vaccine in Bangladesh as well as provide data to support WHO~     prequalification of JE live attenuated SA 14-14-2 vaccine.~   "
147499|NCT01635803|"~     The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment~     of patients with macular edema secondary to a retinal vein occlusion (branch or central) as~     determined by the change in best-corrected visual acuity in the study eye from baseline to~     month 6.~   "
147500|NCT01635790|"~     The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in~     the treatment of patients with DME (OCT central area thickness > 275 μm) as determined by the~     change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6.~   "
147501|NCT01635777|"~     Miltefosine efficacy will be >85%~   "
147502|NCT01635764|"~     The purpose of this study to evaluate the long term safety, tolerability and efficacy of~     adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).~   "
147503|NCT01635751|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.~      GLA5PR GLARS tablet 150mg is a new once-a-day formulation which is made by GL Pharm Tech~     corporation.~      GLARS(Geometrically Long Absorption Regulated System) is new solution to sustained absorption~     by extending the absorption Site.~      To overcome the shortcomings of the currently existing sustained release drug delivery~     technologies the investigators have recently developed a novel drug delivery system to enable~     a drug to be dissolved irrespective of the surrounding environment and further absorbed up to~     colon. The investigators coined this Geometrically Long Absorption Regulated System(GLARS).~   "
147504|NCT01635738|"~     Many studies had demonstrated that probiotics could be applied in the prevention and adjuvant~     treatment for allergic diseases. In this study, we investigate the effects of Lactobacillus~     paracasei GMNL-133(LP), Lactobacillus fermentum GM-090 (LF), and Lactobacillus paracasei~     GMNL-133(LP) with Lactobacillus fermentum GM-090 (LF) combination products used for adjuvant~     treatment of atopic dermatitis and asthma.~   "
147505|NCT01635725|"~     The purpose of this investigation is validate a new bowel preparation scale and to compare it~     to existing bowel preparation scales.~   "
147506|NCT01635712|"~     Hsp90 is a chemical in the body that is involved int he promotion of cancer. SNX-5422 is an~     experimental drug that blocks Hsp90.~   "
147507|NCT01635699|"~     The purpose of this study is to determine the possible effects of uvulopalatopharngoplasty~     (UPPP) -which is a a therapy used on patients with Obstructive sleep apnea syndrome (OSAS- on~     oxidative damage.~   "
147508|NCT01635686|"~     The purpose of this study was to compare the safety and pharmacokinetic characteristics of~     DWP422 25 mg with those of ENBREL 25MG PFS INJ. after subcutaneous injection in healthy male~     volunteers.~   "
147509|NCT01635673|"~     The purpose of this study is to determine if whole body vibration exercise improves~     insulin/glucose dynamics and bone metabolism in Latino Boys.~   "
147545|NCT01635205|"~     This study examines randomized triple-blind clinical trial and the efficacy of paraspinous~     anesthetic block on the treatment of chronic pelvic pain in patients non-responsive to~     pharmacological management. Sixty patients will be randomly divided and allocated into group~     intervention (paraspinous anesthetic block) and control (placebo procedure in subcutaneous~     tissue).~   "
159118|NCT01483365|"~     The investigators are going to examine prospectively the need of luteal support after NC-FET.~   "
147510|NCT01635660|"~     This research project examines the effectiveness of different video laryngoscopes in a~     out-of-hospital emergency intubation. Since in preclinical airway management severe incidents~     with esophageal failures of intubation may partly happen or rather endotracheal Intubation~     may completely fail, it is of great importance to evaluate alternative ways of endotracheal~     intubation in out-of-hospital emergency medicine. Video laryngoscopy has been proven in~     everyday clinical practice and may clinically be superior in most situations when compared to~     endotracheal Intubation using a conventional laryngoscope. No data exist, if different video~     laryngoscope types perform differently in the out-of-hospital setting. The investigators~     hypothesize that there would be no difference with regard to intubation time, intubation~     success, and intubation morbidity between different models of video laryngoscopes.~   "
147511|NCT01635647|"~     Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows~     efficacy against malaria infection when tested in UK volunteers using sporozoite challenge~     experiments. It is a leading candidate vaccination strategy against malaria. In the field,~     Phase I studies have been conducted in adults in Kenya and The Gambia and children and~     infants in The Gambia. The vaccination strategy appears safe and well tolerated in these~     populations, and also shows impressive immunogenicity, not significantly different to that~     seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia~     shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be~     the ones to benefit most from such a vaccine against malaria. With this clinical development~     as background, the investigators now propose to evaluate efficacy against natural malaria~     infection in this important target group for an effective malaria vaccine, that is, 5-17~     month infants and children living in malaria endemic areas. The proposed study area, Banfora,~     Burkina Faso, is highly endemic for Plasmodium falciparum malaria.~   "
147512|NCT01635634|"~     The purpose of this randomized controlled study is to determine the effectiveness of cupping~     in patients with fibromyalgia compared to sham cupping.~   "
147513|NCT01635621|"~     The primary purpose of this multi-centre, double blind-study is to evaluate the clinical~     response of patients with moderate to severe Cohn's Disease (CD) following treatment with~     different doses and dose regimens of Olokizumab, relative to placebo.~   "
147514|NCT01635608|"~     To visualize the localization and to measure the volume of water in the small intestine by~     T2-weighted MRI imaging after oral administration of 240 ml water (non-caloric water) and~     after administration of 240 ml water containing 25.5 g sucrose (105 kcal, caloric water).~      To measure pharmacokinetics of the probe-drugs paracetamol, talinolol and amoxicillin after~     oral administration dissolved in 240 ml non-caloric and in 240 ml caloric water.~   "
147515|NCT01635595|"~     Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors~     according to the TNM 7th ed., however controversy is pending on the unique or dual~     pathogenesis (GERD or gastric-like cancerogenesis). It has been shown that biological~     patterns differ according to the presence (+) or absence (-) of Barrett's epithelium (BIM)~     and gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic~     spreading may differ according to the type of tumor. The investigators retrospectively~     investigated the pathways of lymphatic spreading in 194 consecutive patients who received~     radical surgery for adenocarcinoma of the esophagus and cardia with or without BIM and GIM.~   "
147516|NCT01635582|"~     The purpose of the study is to determine whether a novel computer gaming hand exercise~     regimen would improve hand function, decrease pain/ stiffness and be feasible in people with~     Rheumatoid arthritis or Osteoarthritis affecting the hands.~   "
147517|NCT01635569|"~     Obsessive-Compulsive Disorder (OCD) is a common neuropsychiatric illness beginning in~     childhood. Effective OCD treatments include cognitive-behaviour therapy (CBT) and medications~     but access to treatment is difficult and does not systematically include parents. The~     investigators will evaluate clinical and neural effects of Group-based Family CBT (GF-CBT),~     via a case-control study including: Group 1 - OCD cases receiving GF-CBT (N=90); Group 2 -~     OCD waitlist cases (N=90). Effects will be measured between baseline and completion of 12~     GF-CBT sessions: comparing OCD severity and functioning changes between Groups 1 and 2.~   "
147518|NCT01635556|"~     The goal of this pilot project is to offer outpatient Dialectical Behavior Therapy (DBT)~     treatment as described in Linehan's text (1993), which is considered an effective treatment~     of borderline personality disorder. This treatment consists of weekly individual~     psychotherapy, weekly group skills training, 24 hour telephone consultation, and weekly team~     consultation meetings for therapists. The investigators program is able to offer all of these~     components except the 24 hour phone consultation (which has been modified due to~     employment/union guidelines of interdisciplinary staff working within the investigators~     health care system). This project intends to offer the treatment for a period of 6 months.~      As such, this proposed research project seeks to assess the feasibility of implementing an~     outpatient DBT program within a public health care setting in Canada. This study also aims to~     evaluate this DBT program for clinical effectiveness in its modified format. Specifically,~     the investigators will examine relevant outcomes related to patient functioning (e.g.,~     depression, self-harm and suicidal behaviors, and admissions to hospital/ER visits) and~     improvement (e.g., improved quality of life, meeting work/employment goals) pre and post~     completion of this 6 month treatment program.~      The investigators hypotheses are that each patient will show improvement in all outcome~     variables (e.g., improved mood and quality of life, decreased self-harm, decreased ER visits~     and hospitalization visits, etc). The investigators also hypothesize that the investigators~     modified program will produce comparable results to those from studies of standard outpatient~     DBT.~   "
147519|NCT01635543|"~     Objective:~      The aim of this study is to investigate whether Crohn's Disease patients with peri-anal~     fistulas will suffer from sexual dysfunction in an attempt to help us identify Crohn's~     Disease patients that would benefit from sexual health interventions.~      Hypothesis:~      Crohn's patients with active perianal fistulas will have decreased sexual drive, performance,~     and satisfaction than those with Crohn's Disease in remission.~   "
147520|NCT01635530|"~     The main purpose of this study is to determine whether four weeks treatment with oral~     doxycycline is as effective as three weeks treatment with intravenous ceftriaxone in patients~     with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme~     neuroborreliosis and further define the manifestations and epidemiology of the disease in~     Finland.~   "
147522|NCT01635504|"~     Altered contour of the lower face is a frequent complication of human immunodeficiency virus~     (HIV). HIV facial lipoatrophy or loss of facial fat commonly results from antiretroviral~     therapy. Posterior cheek enlargement leading to a bulky and widened lower facial contour can~     also be seen in HIV. These changes can lead to significant cosmetic disfigurement and have an~     enormous psychosocial impact on patients. They also make individuals vulnerable by making~     them recognizable as persons living with HIV. Posterior cheek enlargement has not been well~     characterized. Both the parotid salivary gland and the masseter muscle are located in the~     posterior cheek region. Although parotid gland enlargement in a common complication of HIV,~     it is unknown whether enlargement of the masseter muscle also contributes. The investigators~     plan to study posterior cheek enlargement in HIV positive individuals. The investigators also~     plan to use botulinum toxin A as a novel treatment to improve the altered lower facial~     contour seen in HIV. This treatment has already demonstrated efficacy in HIV negative~     individuals with enlargement of the masseter muscle. Botulinum toxin has also been used~     safely in the salivary glands in individuals with excessive drooling resulting from~     neurological disease. In a trial HIV+ patient, the investigators have already demonstrated~     the efficacy of using botulinum toxin A in the treatment of posterior cheek enlargement,~     resulting from both parotid and masseter muscle enlargement. The investigators anticipate~     this study will increase our understanding of posterior cheek enlargement in HIV and lead to~     the development of a novel treatment for this important complication.~      The investigators hypothesize that posterior cheek enlargement in HIV+ patients will in some~     cases result from both masseter muscle hypertrophy as well as parotid gland enlargement. The~     investigators also hypothesize that the treatment of posterior cheek enlargement with~     botulinum toxin A will result in a more aesthetically appealing lower facial contour in HIV+~     patients. This has already been demonstrated in a trial HIV+ patient, in which there was a~     dramatic change in the volume of the masseter muscle and parotid gland 12 weeks after~     treatment with botulinum toxin A.~   "
147523|NCT01635491|"~     The purpose of this study is to describe gastrointestinal motility and transit times in~     healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal~     transit time (GITT) to GITT obtained using radioopaque markers.~      The investigators end points are to measure the transit times through different segments of~     the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.~      The study is descriptive and is designed to test and evaluate the usefulness of the Motilis~     3D-Transit system. The investigators hypothesize, that with the system transit times through~     different segments of the gastrointestinal canal can be measured.~      The design is made for evaluating the transit times, the inter-subject reproducibility and~     comparison with gold standard for colonic transit time measurement.~      The investigators have chosen to include 20 healthy volunteers.The study is descriptive and~     therefore power calculation is not needed.~   "
147524|NCT01635478|"~     EMERGENCY CANCER PAIN MANAGEMENT HAS BEEN INCONSISTENT AND INADEQUATE ACROSS THE GLOBE. THIS~     STUDY AIMS TO KNOW EMERGENCY ROOM CANCER PAIN PATTERNS AND TREATMENT ADEQUACY IN TERTIARY~     CARE CANCER HOSPITALS.~   "
147525|NCT01635465|"~     Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a~     recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine~     plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study~     with small sample.~   "
147526|NCT01635452|"~     This is a multi-center, prospective, non-interventional study of patients who have been~     diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a~     pre-operative treatment with ESMYA.~      The objectives of the study are to characterize and describe treatment with ESMYA and to~     evaluate the safety, effectiveness, and HRQL outcomes in this population~   "
147527|NCT01635439|"~     The purpose of the study was to compare the safety and efficacy of two agents used in~     induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2~     (Dinoprostone vaginal Tablet).~   "
147528|NCT01635426|"~     The study will compare the effect of Aspirin versus clopidogrel effect on uterine perfusion~     in women with unexplained recurrent pregnancy loss with decreased uterine artery pulsatility~     index.~      Null hypothesis: Women with recurrent miscarriage have the same blood flow after aspirin or~     clopidogrel treatment compared to their uterine artery pulsatility index before treatment.~   "
147529|NCT01635413|"~     This research is being done to compare the physical and quality of life benefits of two~     different types of exercise- tai chi versus strength training- for female cancer survivors~     who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to~     participants in a group that performs flexibility and relaxation exercises, which is expected~     to have different benefits than either tai chi or strength training.~   "
147530|NCT01635400|"~     The purpose of this study is to find out the correlation between uridine diphosphate~     glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and the side effect and efficacy of~     irinotecan in patients with small cell lung cancer.~   "
147531|NCT01635387|"~     Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study~     was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor~     improves mortality and cardiovascular outcomes in these high-risk population.~   "
147532|NCT01635374|"~     Achalasia is an esophageal motility disease that usually requires surgical intervention~     (esophagomyotomy). Laparoscopic techniques have reduced the morbidity associated with~     myotomy, but post-op GERD, wound infection, hernia and incisional pain are common. A new~     NOTES based procedure, per-oral endoscopic esophagomyotomy (POEM), has been developed that~     eliminates the need for skin incisions. All patients enrolled in this study, will have a~     thorough pre-op workup (including upper endoscopy, upper GI radiographs, high resolution~     esophageal manometry) confirming the diagnosis of achalasis at the Northwestern Esophageal~     Center. In this procedure, performed in the operating room under general anesthesia, a~     flexible endoscope is passed into the esophagus, a mucosal flap and a submucosal tunnel is~     created. This tunnel extends onto the stomach. The inner circular muscle layer of the lower~     esophagus and sphincter (LES) is identified and a myotomy is started 3-4cm distal to the~     mucosal flap and carried all the way onto the stomach. The mucosal opening is then closed~     with standard endoscopic clips. Patients will be admitted to the hospital and a gastrograffin~     esophagram will be performed on post-op day 1 to rule out esophageal leak. All patient will~     have a 2-3 week post-op appointment~      Patients with a confirmed diagnosis of achalasia may be offered POEM. The investigators~     hypothesize that POEM is feasible and safe and can effectively reduce residual LES pressure~     (as determined by manometry) and improve patients symptoms and quality of life.~   "
147546|NCT01635192|"~     Probiotics have become very popular and are by WHO defined as Live microorganisms which when~     administered in adequate amounts confer a health benefit on the host. For example,~     probiotics have been shown to contribute to improvements of abdominal discomfort and~     intestinal inflammation. The main hypothesis behind the present study is that probiotics~     influences mucosal regulatory systems, particularly the actions of the hormone Angiotensin II~     locally in the intestinal mucosa.~   "
147728|NCT01632813|"~     The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the~     hypothesis that children with a congenital heart disease (CHD) show more neurocognitive~     impairment at the second follow-up at 7 years old than at the first follow-up at the age of~     4, compared to healthy controls.~   "
147533|NCT01635361|"~     About 25% medicines prescribed for long term conditions are not taken as directed, and~     approximately 15% people receiving a new medicine take few, if any, doses. The New Medicine~     Service (NMS) is a community pharmacy service that started in England in October 2011 which~     involves the pharmacist providing additional support to patients starting a new medicine for~     some breathing problems (asthma & COPD), high blood pressure, adult onset diabetes or~     medicines which reduce blood clotting. It aims to improve the way patients take their~     medicines improving outcomes and reducing costs to the National Health Service (NHS).~      The investigators will assess the effectiveness and cost effectiveness of the NMS using a~     research study where some people will receive the NMS, and some won't, so The investigators~     can look at the effect of the NMS on problems with their medicines, medicines taking and use~     of the NHS in general. Data will be collected in the East Midlands, South Yorkshire and~     London areas.~      The investigators will recruit 500 patients from a range of different pharmacies and follow~     them up at six, ten and twenty six weeks after starting their new medicine to assess effects~     on medicines taking behaviour, patients' reported problems with medicines, referrals to their~     General Practitioner (GP) and use of NHS resources. The investigators will compare the data~     gathered from this study with that being collected routinely by all pharmacies in England to~     provide wider estimates of cost effectiveness.~      The investigators will also explore how the NMS service is being implemented by pharmacies. A~     sample of patients from the main study will be followed in more detail. This will involve~     recording the consultations with the pharmacist and also interviewing patients about their~     experience of the service. The investigators will interview the patients GP to investigate~     their views of the service. The investigators will also try to understand why people decline~     the invitation for the NMS~   "
147534|NCT01635348|"~     The purpose of this research study is to compare two different exercise treatments for~     walking problems in older adults. The investigators want to determine if participation in the~     exercise programs will improve walking and thinking abilities.~   "
147535|NCT01635335|"~     The proposed project will test an HIV prevention intervention for Latino parent-adolescents~     dyads. This randomized controlled trial will:~        1. Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV~          prevention intervention or a family-based General Health Promotion condition.~        2. Determine the efficacy of the Latino Family-based HIV prevention intervention from~          assessment of changes in HIV-related sexual behavior and attitudes over 18 months among~          a sample of 320 Latino parent-adolescent dyads.~        3. Determine the efficacy of the Latino Family-based HIV prevention intervention from~          assessment of changes in family relationships and parental monitoring/supervision over~          18 months among a sample of 320 Latino parent-adolescent dyads.~        4. Examine the association of other important constructs, such as religiosity,~          acculturation, cultural values, and sexual socialization with the primary outcomes.~      Based on a thorough review of the literature and preliminary data from a recent, small pilot~     study, the investigators hypotheses are:~        1. Compared to the General Health Promotion Control condition, the Family-Based HIV~          Prevention intervention will result in greater change with regard to primary outcome~          measures of safer sexual behavior (recent sexual activity, the number of unprotected sex~          acts, and intentions to use condoms) and safer HIV-related attitudes.~        2. Compared to the General Health Promotion Control condition, the Family-Based HIV~          Prevention intervention will result in greater change with regard to family~          relationships and parental monitoring/supervision through improved parent-child~          communication skills and they will mediate the intervention impact.~        3. Religiosity, acculturation, cultural values, and sexual socialization will have~          meaningful associations with the primary outcomes and will act as moderators of~          intervention impact.~   "
147536|NCT01635322|"~     The purpose of this study is to evaluate the correlation between the restoration of the~     sagittal balance and the improvement of the Quality of Life for patients with adult~     scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a~     spinal fusion surgery.~   "
147537|NCT01635309|"~     Worldwide 200 million adults annually undergo major noncardiac surgery and 5 million of these~     patients will suffer a major vascular complication. Despite the magnitude of this problem our~     capacity to predict these events is limited. Although perioperative myocardial infarction~     (MI) is the most common major perioperative cardiac complication, little is known about its~     pathophysiology. Coronary computed tomography angiography (CTA) is a potential non-invasive~     method for the detection of coronary artery disease and cardiac risk stratification in the~     non-operative setting; however, the value of this test to enhance risk prediction among~     patients scheduled for noncardiac surgery is unknown. This study is an international~     prospective cohort study to determine among patients with, or at risk of, atherosclerotic~     disease who are undergoing noncardiac surgery: 1) if preoperative coronary CTA has additional~     predictive value for the occurrence of major perioperative cardiac events and 2) the~     underlying coronary anatomy associated with perioperative MIs.~   "
147538|NCT01635296|"~     This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and~     efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous~     leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard~     induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2~     subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients who~     have relapsed or are refractory after at least one cytarabine/anthracycline containing~     regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2~     intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4 cycles of~     therapy, patients in Arm A who achieve hematologic response may continue additional cycles~     until disease progression.~   "
147539|NCT01635283|"~     The primary purpose of this phase II clinical trial is to determine the safety and effect on~     survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a~     treatment for low-grade glioma patients. Other goals of this study are to determine if the~     vaccine can cause an immune response against patients' cancer cells and slow the growth of~     their brain tumors~   "
147540|NCT01635270|"~     The purpose of this study is to establish on the market and to clinically evaluate a new~     strategy of treatment for patients with locally advanced non-small cell lung cancer using~     deformable repositioning of 4D imaging.~   "
147541|NCT01635257|"~     Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high~     D-dimer level should undergo a second level diagnostic test such as Multidetector Computed~     Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is~     expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is~     safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic~     role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT),~     TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or~     Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No~     previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined~     (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of~     multiorgan US.~      Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical~     suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value~     ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE~     diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA.~     PE was considered echographically present if CUS was positive for DVT or TTE was positive for~     RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the~     single and multiorgan US was calculated.~   "
147608|NCT01634373|"~     Objective:~      Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate~     Tablets 300 mg.~      Study Design:~      Randomized, Two-Way, Crossover, multiple Dose, and Open-Label~   "
177162|NCT01246245|"~     The incidence of pin site infection is related to the nursing management of external~     fixation.~   "
147547|NCT01635179|"~     To prevent bronchial aspiration during induction of anaesthesia it has been a common~     procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and~     thereby prevent aspiration. During the last ten years the efficiency of this maneuver has~     been discussed, since it probably prolong the intubation time and do not significantly~     reduces the risk of aspiration.~      The hypothesis is that Sellicks Maneuver prolong the time of intubation and reduces the view~     of the laryngeal inlet, during intubation with a videolaryngoscopy.~      The hypothesis is tested by a double-blinded randomized study where patients is intubated~     twice, with and without Sellicks Maneuver, in a randomized order. The specific cricoid~     pressure is blinded to the personal performing the intubation.~   "
147548|NCT01635166|"~     The purpose of this study is to monitor the performance of the DeltaMotion cup system in the~     treatment of patients with hip joint disease requiring a total hip replacement.Patients who~     enter the study will be evaluated at regular intervals following hip surgery using patient,~     clinical and x-ray assessments.~   "
147549|NCT01635153|"~     The objective of this randomized, controlled trial is to determine if adding a~     protein-calorie supplement (PCS) to the standard treatments for tuberculosis (TB) and HIV~     will improve health outcomes. The investigators will enroll 180 HIV-positive women with newly~     diagnosed active TB and without prior anti-retroviral therapy (ART). At baseline, the~     investigators will conduct dietary interviews, measure body composition, randomize subjects~     to receive a PCS (plus micronutritional supplements [MNS]) or control (MNS only) for the~     6-month duration of anti-TB therapy (ATT) plus an additional 2 mos (8 mos total). Subjects~     will be followed monthly and have CD4 counts at baseline, 2, 8 and 12 months. At 2 months~     (i.e., at the end of the 4 drug intensive phase of TB treatment and start of the 2 drug~     continuation phase), all subjects will be started on anti-retroviral therapy (ART) based on~     Tanzanian Ministry of Health guidelines (currently: AZT/3TC/efavirenz). The primary endpoint~     will be change in CD4 count after 8 months (i.e., at end of PCS/MNS intervention and 2 months~     after completion of ATT).~   "
147550|NCT01635140|"~     Hypofractionated radiotherapy reduce the patient and family burden through decreasing the~     overall treatment time. This study is to evaluate the clinical end results of the~     hypofractionated radiotherapy in DIPG compared to the conventional treatment. The~     non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital,~     stay or engagement, for more than its half with the same results.~   "
147551|NCT01635127|"~     Evaluation whether canakinumab leads to improvement of urticaria~   "
147552|NCT01635114|"~     The purpose of this study is to investigate the effects of the antioxidant resveratrol on~     liver fat content, body-composition and insulin sensitivity~      Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have~     health benefits such as improving fat metabolism, insulin action, and possibly extending~     lifespan. resVida™ is the name for the dietary supplement containing the natural antioxidant~     resveratrol. resVida™ will be supplied by DSM Nutritional Products, Ltd.~      resVida™ is considered a dietary supplement, and therefore it is not an approved drug by~     German Authority. It is regulated like a food. The makers of resVida™ make no claim that this~     supplement is meant to treat any ailment.~      This study is designed to investigate the health benefits of resveratrol.~   "
147553|NCT01635101|"~     The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV)~     acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates~     and infants (age < 2 years) compared to placebo plus standard of care rescue opioids as well~     as characterize the concentration-effect relationship (PK/PD) of the intravenous~     acetaminophen as compared to the control group.~   "
147554|NCT01635088|"~     Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects~     in chronic asthma. However, they also have largely unappreciated early effects when initiated~     as a controller therapy in a steroid-naïve population. Impulse oscillometry might reveal such~     an early effect better than spirometry. The investigators sought to examine the onset of~     action and sustained effects over 4 weeks treatment of mometasone furoate as measured by~     Impulse Oscillometry System (IOS) versus spirometry.~   "
147555|NCT01635075|"~     People with schizophrenia have two- to three-times the mortality risk of the general~     population. This is primarily due to their unusually high rates of cigarette smoking, as well~     as other cardiovascular risk factors such as physical inactivity, obesity, high blood~     cholesterol and diabetes. Effective smoking treatments are needed to reduce morbidity and~     mortality in this population. Over a dozen experimental studies indicate that walking and~     other forms of exercise acutely reduce cigarette craving, nicotine withdrawal symptoms and~     smoking behavior in non-psychiatric smokers. However, the effects of acute exercise on~     smoking measures have not been studied in smokers with schizophrenia. This study will use a~     within-subjects, repeated-measures design, in which participants will undergo 4 laboratory~     sessions (order counterbalanced across participants): (1) smoking cues followed by exercise,~     (2) smoking cues followed by passive activity, (3) neutral cues followed by exercise, (4)~     neutral cues followed by passive activity. Outcome measures include cigarette craving,~     nicotine withdrawal symptoms, mood and smoking behavior. If the results of this study~     indicate that walking acutely reduces craving and smoking in smokers with schizophrenia, the~     next step in this research would be to test the effectiveness of a smoking cessation~     intervention that incorporates exercise bouts as a behavioral strategy for improving smoking~     cessation rates in this population.~   "
147556|NCT01635062|"~     The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers~     renin-angiotensin system activity.~   "
147557|NCT01635049|"~     The purpose of this research study protocol is to collect imaging data on embryos followed to~     blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome~     screening (CCS) results, implantation and live birth.~   "
147558|NCT01635036|"~     The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva~     12-well Dish.~   "
147559|NCT01635023|"~     Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.~   "
147609|NCT01634360|"~     A 48-month open label multi-centered extension study to evaluate the long-term safety,~     tolerability and efficacy of E2007 in patients with Parkinson's Disease with wearing off~     motor fluctuations and on period Dyskinesias.~   "
154835|NCT01539590|"~     The study will evaluate the effect of BB3 to preserve myocardial (heart) tissue and function~     following myocardial infarction (heart attack).~   "
147560|NCT01635010|"~     Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase~     cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled~     clinical studies investigating the independent effects of OSA in the development of~     cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders~     such as inflammatory response, oxidative stress and vascular changes. The investigators~     hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular~     consequences in OSA patients would be less important.~      The purpose of this study is to analyze the effects of OSA in the absence of MS, on~     inflammatory, oxidative stress and vascular markers; to verify the influence of excessive~     daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal~     continuous positive airway pressure (nCPAP)in theses parameters.~   "
147561|NCT01634997|"~     The primary objective is to identify compare SCOUT DS to random capillary glucose for~     identification of at-risk subjects with dysglycemia defined by hemoglobin A1c ≥ 6.0%.~   "
147562|NCT01634984|"~     Selected 400 cases of women with primary breast cancer who were treated with operation~     randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly~     selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect~     the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.~   "
147563|NCT01634971|"~     Postoperative pancreatic fistula (POPF) and other surgical complications are common after~     pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct~     is important and a stent is usually placed in the operation, but it is still controversial~     whether the stent drainage is internal or external.~   "
147564|NCT01634958|"~     Specific immunotherapy for IgE mediated sensitization to grass pollen~      4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the~     optimum dose.~   "
147565|NCT01634945|"~     The proposed project is aimed at testing two interventions, namely a highly bioavailable iron~     compound and a combination of SP plus amodiaquine for intermittent preventive treatment (IPT)~     of malaria, to reduce anaemia in very young children.~   "
147566|NCT01634932|"~     Iron deficiency (ID) with or without anemia is still a main public health problem in~     sub-Saharan Africa and Southern Asia, especially in vulnerable population groups such as~     children below 5 years of age and women of reproductive age. The etiology of ID is~     multifactorial; but major causes are low iron dietary bioavailability and intake from~     monotonous cereal-based diets aggravated by chronic parasitic infections such as malaria and~     soil-transmitted helminthes. Approaches such as dietary diversification, supplementation with~     pharmacological iron doses, public health measures (e.g. deworming, malaria control) and food~     fortification with different iron compounds have notably reduced morbidity and mortality~     caused by ID but have not been universally successful. Biofortification is a new promising~     approach to combat micronutrient deficiencies such as ID. It is defined as the process of~     increasing the content and bioavailability of essential nutrients such as iron in crops by~     traditional plant breeding and/or genetic engineering. Pearl millet is a staple food for many~     people living in different areas of West Africa (e.g. Northern Benin) and India, two parts of~     the world, where ID is still widely prevalent. Therefore, pearl millet was one of the crops~     targeted for iron biofortification by HarvestPlus.~      To improve human iron status successfully, the additional iron gained through~     biofortification has to be at least as bioavailable as the iron in regular peal millet~     varieties. For that reason we are planning an iron absorption study where we will investigate~     the iron bioavailability from an iron-biofortified millet variety and compare it with the~     iron bioavailability from a regular-iron millet variety and from regular-iron millet~     fortified post-harvest with ferrous sulfate (FeSO4). Iron absorption will be determined by~     incorporation of labeled iron into erythrocytes, at least 14 days after the administration of~     the test meals containing labeled iron (stable isotope technique). The three different test~     meals based on 1) regular-iron, 2) iron-biofortified and 3) post-harvest iron-fortified~     millet will be administered as multiple meals i.e. each study participant will consume each~     test meal for a period of 5 days (2 portions/day; one in the morning, one for lunch). Twenty~     apparently healthy Beninese women with a low/marginal iron status (serum ferritin < 25 ;g/L),~     non-anemic or mildly anemic (hemoglobin >90 g/L), 18-30 years of age with a body weight < 65~     kg and normal body mass index will be included in the study.~      The results of the study will provide important insights on the iron bioavailability from~     regular, biofortified and post-harvest fortified staple crops such as pearl millet when~     feeding multiple meals as part of a more complex diet. The results can be applied to~     different meals based on pearl millet such as the West African millet pastes or the Indian~     flat breads.~   "
147567|NCT01634919|"~     •The purpose of this study is to compare the performance between liver biopsy and~     non-invasive fibrosis assessments evaluating anti-fibrotic efficacy of peginterferon plus~     ribavirin in patients with hepatitis C pre- and post-treatment~   "
147568|NCT01634906|"~     Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB)~     may be protective against atherosclerosis. However, statins may have an effect on ery-apoB.~      Objective: to investigate the effect of statins on ery-apoB levels.~      Study design: a non-randomized intervention study. Ery-apoB will be measured twice in~     volunteers who are on statin therapy for medical reasons. After a baseline measurement of~     ery-apoB volunteers will discontinue their statin use for a period of six weeks followed by a~     second measurement of ery-apoB. Consecutively subjects will start with their original statin~     therapy again.~      Study population: patients on statin therapy aged 18 years or older.~      Intervention: temporary discontinuation of statin therapy for a period of six weeks.~      Main study endpoints: changes in ery-apoB levels.~      Risks, burden and benefits on participation: volunteers will visit the outpatient clinic~     twice, the second visit will be exactly six weeks after the first visit. The volunteers'~     general practitioner and medical specialist (internist or cardiologist) will be informed~     about their participation. Subjects have to fast for 10 hours before every visit and venous~     blood samples will be drawn on both visits (a total of 36ml of blood). Subjects will~     discontinue their usual statin therapy for a period of six weeks. No major risks are involved~     with temporary discontinuation of statin therapy in stable chronic cardiovascular disease.~     Volunteers will receive 25 euro's in total for participation. Participation serves to further~     investigate the relation of statins and potentially beneficial binding of apoB on~     erythrocytes.~   "
147569|NCT01634893|"~     Patients with recurrent, refractory or metastatic solid tumors have a dismal prognosis with~     few viable treatment options. Hydroxychloroquine (HCQ) is an agent that has been widely used~     to treat malaria. Because HCQ also inhibits autophagy, a process central to survival of~     cancer in the face of metabolic stress, including the effects of anti-cancer therapy, it is~     now in human cancer trials combined with other agents to attempt to boost the efficacy of~     those agents. Autophagy inhibition improves the activity of sorafenib in hepatocellular~     carcinoma.~      Sorafenib is an oral multi-kinase inhibitor that blocks not only receptor tyrosine kinases~     such as KIT, VEGFR and PDGFR but also serine/threonine kinases along the RAS/RAF/MEK/ERK~     pathway.~      The investigators propose to treat patients with refractory or relapsed solid tumors with~     sorafenib, to boost its efficacy while attempting to mitigate its toxicity by combining with~     HCQ.~   "
155057|NCT01536704|"~     To compare the bio equivalence of new nicotine lozenge formulation with the reference~     nicotine lozenge so as to deliver the same nicotine blood profile.~   "
147570|NCT01634880|"~     Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery~     followed by postoperative radiation therapy. Studies have shown the superiority of combined~     modality therapy compared to surgery alone. Despite the addition of postoperative radiation~     therapy, the five-year survival for locally advanced salivary gland malignancies is poor~     (less than 60%). In salivary gland malignancies, the epidermal growth factor receptor (EGFR)~     is expressed in 25-85%; in certain histological types, like salivary duct carcinomas, the~     expression is higher. EGFR is a promising target of anticancer therapy. In squamous cell~     carcinoma of the head and neck, a phase III trial utilizing cetuximab added to radiation~     therapy improved both locoregional control and overall survival compared to radiation alone.~     Panitumumab is a novel, human, IgG2 EGFR monoclonal antibody that may be better tolerated and~     more efficacious than cetuximab. Here, the investigators hypothesize that the addition of~     panitumumab to standard radiotherapy in locally advanced salivary gland malignancies will~     improve recurrence-free survival (RFS).~   "
147571|NCT01634867|"~     This study will evaluate using intraosseous vascular access and intravenous vascular access~     to give pediatric patients the necessary medications to perform rapid sequence intubation,~     for patients with airway difficulties.~   "
147572|NCT01634854|"~     This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous~     oxytocin (Pitocin) in multiparous women who present at term for labor induction.~   "
147573|NCT01634841|"~     This will be a systematic investigation of the role of walnuts in preventing or slowing age~     related cognitive decline and age related macular degeneration. 700 subjects will be~     recruited between 2 sites, Loma Linda University in California, USA and Hospital Clinic in~     Barcelona, Spain. Participants will be randomly assigned to either the walnut group or the~     control group for a 2 year intervention. Baseline and annual data will be collected and~     analyzed.~   "
147574|NCT01634828|"~     The purpose of this study is to develop a mathematical algorithm which the investigators plan~     to use to more accurately estimate intraoperative blood loss.~   "
147575|NCT01634815|"~     Evaluation of a new biological criterion, the local capillary blood lactates to optimize the~     management of patients with chronic critical ischemia requiring revascularization fast.~     Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent~     ischemia in a limb revascularized.~   "
147576|NCT01634802|"~     The purpose of this study is to determine whether the use of a Computerized Decision Support~     System (CDSS) in form of alerts to clinicians enhances early detection of immunological~     treatment failure in HIV patients.~   "
147577|NCT01634789|"~     The purpose of this study is to evaluate 3 test formulations relative to a reference~     formulation.~   "
147578|NCT01634776|"~     Fatty acids or omega-3s are important in the human diet for brain development. Of the three~     main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3;~     docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been~     shown to be important in brain function. Conversely, little is known about the effects of ALA~     even though the body can make DHA and EPA from it. Because the rate at which ALA makes DHA~     and EPA is very slow, ALA is not considered an important source of DHA and EPA. However, in~     the human diet, ALA is more readily available, more easily consumed, and less expensive~     relative to animal sources of DHA and EPA. So, it is very important that the investigators~     explore the effects of supplementation with ALA. It is possible that the ALA to DHA and EPA~     conversion rate can be altered by methylation, an epigenetic form of gene expression and~     regulation. In the present study, the investigators will examine memory abilities and genetic~     baselines in 16-month-olds. The investigators will then supplement their food with ALA or~     control oil for 4 months. At 20 months, the investigators will collect outcome data on~     memory, fatty acid status, genetic variations, and methylation. The investigators hypothesize~     that the ALA supplementation will result in an increase in the rate of ALA to DHA and EPA~     conversion through methylation and genetic variations and subsequently, memory abilities will~     improve. The data from this study will be used to design a larger R01 grant.~   "
147579|NCT01634763|"~     Estimation of the Maximum tolerated dose (MTD) and/or Recommended dose (RD) of LDK378 as a~     single agent when administered orally to Japanese patients with tumors characterized by~     genetic alterations in anaplastic lymphoma kinase (ALK)~   "
147580|NCT01634750|"~     Background:~      - Hereditary inclusion body myopathy (HIBM) is a genetic disorder caused by mutations in a~     gene called GNE. This gene is responsible for producing a sugar called sialic acid. Low~     levels of sialic acid may cause muscle problems. Symptoms of HIBM include walking~     difficulties and muscle weakness, which usually start in a person s 20s or 30s and become~     worse over time.~      Researchers are studying a drug called ManNAc. It may be useful for treating HIBM. However,~     this drug is still being tested. Researchers want to see how ManNAc is absorbed into and~     removed from the blood. They will not be looking specifically at whether ManNAc can stop or~     slow the symptoms of HIBM.~      Objectives:~        -  <TAB>To study how MaNAc is absorbed into and removed from the blood in people with HIBM.~        -  <TAB>To study of safety of ManNAc in people with HIBM.~      Eligibility:~      - Individuals between 18 and 70 years of age who have HIBM.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have a 3 to 4-day inpatient stay for the main part of the study.~        -  Participants will be divided into groups of six. In each group, four will take ManNAc~          and two will take a placebo. Participants will not know which one they will receive.~        -  Participants will have a single dose of either ManNAc or placebo. They will be monitored~          for any possible side effects. Frequent blood samples will be collected during the 4-day~          stay.~        -  No treatment for HIBM will be provided as part of this study.~   "
147581|NCT01634737|"~     This study evaluates the diagnostic efficacy of CAP System (capsulated hydrophilic carrier~     polymer) for recombinant tropomyosin from shrimp extract in discriminating between subjects~     allergic to shrimp with CAP positive subjects allergic to mites, crustaceans asymptomatic but~     with a positive CAP to shrimp, to identify those at greatest risk of food reactions.~   "
147582|NCT01634724|"~     To test whether GnRHa withheld 2-3 days before ovulation trigger reduces the incidence of~     ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic~     ovaries (PCOs) who have been treated with gonadotropins for in vitro fertilization (IVF) or~     Intracytoplasmic sperm injection (ICSI).~   "
147583|NCT01634711|"~     The purpose of this study is to evaluate the safety of a resorbable polymer implant (Soft~     Tissue Regeneration's L-C Ligament) for replacement and regeneration of the anterior cruciate~     ligament (ACL). Approximately 15 patients at 2-3 different hospitals in Europe will~     participate in this study. The hypothesis of this study is that the L-C Ligament will~     successfully regenerate the ACL with clinical outcomes similar to or better than surgical~     intervention with auto graft tissue.~   "
147584|NCT01634698|"~     The relative-dose-response test (RDR) is considered to be the most accurate method for~     evaluating vitamin A nutritional status (VANS) in patients suffering from liver disease, as~     it infers the reserves of the vitamin in the liver. However, for the RDR test to reflect VANS~     in patients suffering from chronic liver disease, factors inherent to the disease need to be~     considered, such as possible malabsorption, advanced age, a drop in synthesis and/or the~     release of retinol binding protein (RBP), which would result in an inadequate response to the~     RDR test. Thus, the objective of present study is to assess the adequacy of two different~     protocol for using the RDR test in patients with cirrhosis and cirrhosis-related~     hepatocellular carcinoma.~      Methods: The sample group was comprised of 178 patients at Federal University of Rio de~     Janeiro University Hospital (111 men) with several etiologies of liver cirrhosis at different~     stages in the progression of the disease. They were sorted into two groups, according to the~     retinyl palmitate dosage (1500 IU or 2500 IU) received at T0 (blood sample taken following a~     12-hour fast). Following supplementation, the investigators took further blood samples five~     and seven hours later (T5 and T7). The investigators assessed VANS via concentrations of~     serum retinol and RBP, as well as by way of the RDR test. The cutoff points the investigators~     used for denoting inadequacy in the indicators retinol and RDR were, respectively, < 1.05~     µmol/L and ≥ 20%. To classify the degrees of severity of the disease the investigators used~     the criteria established by Child & Pugh (1973).~   "
147585|NCT01634685|"~     This is a phase I study incorporating bavituximab into the care of patients with rectal~     adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no~     reference therapy as we are trying to identify the MTD of bavituximab in this combination.~   "
147586|NCT01634672|"~     The purpose of this study is to determine the prevalence of GERD among chronic kidney disease~     with peritoneal dialysis and hemodialysis in Korea.~   "
147587|NCT01634659|"~     The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily~     disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.~   "
147588|NCT01634646|"~     This observational placebo-controlled pilot study is intended to document whether or not~     Lyzme5, an over-the-counter (OTC) proprietary nutritional supplement product can positively~     impact, (a) weight and, (b) cholesterol levels in man.~   "
147589|NCT01634633|"~     The aim of this study is to investigate the prevelence of endometrial nerve fibers in~     different gynecological pathologies~   "
147590|NCT01634620|"~     Objective: To characterize FeNO levels that may be indicative of eosinophilic airway~     inflammation in patients with chronic obstructive airways disease~      Number of participants: Approximately 200 subjects will be enrolled~      Reference product: NIOX MINO® Instrument (09-1100)~      Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be~     performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO®~     User Manual~      Safety assessments: The Investigator is responsible for the detection, reporting, and~     documentation of events meeting the definition of an Adverse Event (AE) and/or Serious~     Injuries as provided in this clinical investigation plan from the time that informed consent~     has been provided and during the study period~      Criteria for evaluations: This is an observational, pilot study and there are currently no~     plans for a formal statistical analysis. Information gained from this study may used to~     design subsequent studies in patients with chronic obstructive airways disease. Information~     collected will be summarized in a clinical study report but will not be subject to formal~     hypothesis testing~   "
147591|NCT01634607|"~     This study will compare and assess the prevalence of osteopenia and vitamin D deficiency as~     well as effects of TDF on the patients' bone among HIV positive and negative patients.~   "
147592|NCT01634594|"~     Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or~     the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that~     have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several~     different regimens are used to lower the patient's blood pressure, such as vasodilators,~     autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the effects~     that these agents have on the QTc and Tp-e intervals during deliberate hypotension is not~     known. Virtually every kind of anesthetic is reported to have some effect on the QTc and Tp-e~     intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the amount of~     anesthetics and drugs used to maintain low blood pressure is not small. Therefore, the effect~     that these agents may have on the QTc and Tp-e intervals may not be negligible. The~     investigators of the present study found that the high dose of commonly used hypotensive~     agents tend to prolong these variabilities to some extent. This study will be able to provide~     insight as to which hypotensive anesthesia regimen has the least effect on the QTc and Tp-e~     intervals, and therefore will be helpful in minimizing cardiovascular risks of deliberate~     hypotensive anesthesia.~   "
147593|NCT01634568|"~     A double-blind, randomised, placebo-controlled study of the safety, tolerability and~     pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male~     volunteers~   "
147594|NCT01634555|"~     The purpose of this study is to assess the effect of concomitant ramucirumab (IMC-1121B) on~     the pharmacokinetics of irinotecan and its metabolite SN-38 when coadministered with folinic~     acid and 5-fluorouracil, in participants with advanced malignant solid tumors resistant to~     standard therapy or for which no standard therapy is available.~   "
147595|NCT01634542|"~     This multicenter, prospective, non-interventional study will evaluate the prevalence and~     characteristics of patients with persistent symptoms of schizophrenia and the course of their~     illness over 24 months.~   "
147596|NCT01634529|"~     The purpose of this study is to investigate whether V158866 is safe when given to healthy~     male subjects in single and multiple doses.~   "
148985|NCT01616355|"~     The present study tried to integrate all aspects of denture care: patient satisfaction with~     the treatment, denture decontamination and base material defects after decontamination~     processing.~   "
147597|NCT01634516|"~     There has been an increase in asthma and allergic disease prevalence, especially in children.~     Given the high prevalence, and the associated high disease burden and costs, there is an~     urgent need to identify effective strategies for the primary prevention of asthma and~     allergy. A systematic review of the literature has found strong supportive epidemiological~     evidence of a protective role for the Mediterranean Diet (MD).~      The investigators aim is to undertake a pilot trial in a sample of pregnant women to~     establish recruitment, retention, a measurable change to a dietary intervention encouraging~     greater adherence to a MD during pregnancy, and acceptability of the dietary advice and diet~     modifications.~      This pilot study will be a 2-arm randomised controlled trial (RCT) in a sample population of~     around 50 Scottish pregnant women.~      This work ultimately aims to contribute to improving health outcomes through seeking to~     reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable~     in informing the subsequent planned definitive parallel group RCT.~   "
147598|NCT01634503|"~     This study is to determine maximum tolerable dose (MTD) of GX 188E by defining the safety~     profile the safety and maximum tolerated dose of GX-188E administered by electroporation in~     Cervical Intraepithelial Neoplasia grade 3 (CIN 3) patients.~   "
147599|NCT01634490|"~     Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively~     evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of~     the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A~     food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance~     acquisition. Main demographic and clinical characteristics were collected for each patient.~   "
147600|NCT01634477|"~     1. To describe the morbidity and clinical characteristics among HIV-infected patients and~          HIV-uninfected patients.~        2. To identify the risk factors for the complication or morbidity among HIV-infected~          patients and HIV-uninfected patients.~        3. To describe the mortality among HIV-infected patients and HIV-uninfected patients.~        4. To identify the risk factors for the cause of death among HIV-infected and~          HIV-uninfected patients.~   "
147601|NCT01634464|"~     In the PREOBE projects it is aimed to obtain genetic and biochemical biomarkers for the~     programming of obesity in early stages of life. This can be achieved by studying pregnant~     women with normal weight, overweight, obesity and gestational diabetes, and by analyzing how~     these conditions could impact on fetal growth and development; the risk of obesity in the~     offspring during the first 3 years of life will be also assessed (genetic polymorphisms of~     the most recognized genes related to obesity; gene expression of placental biomarkers~     indicators of early programming, polyunsaturated fatty acids, immunological and~     pro-inflammatory markers, analysis of endogenous and exogenous lipid peroxidation, allergies~     & neurodevelopmental assessment...). Moreover, the interaction of pathological maternal~     conditions with confounder factors that could have a role in the proposed outcomes will be~     also studied (maternal and child dietary intake, medical history and socioeconomic &~     environmental factors).~   "
147602|NCT01634451|"~     Intensive Care Units (ICUs) across Scotland are working with the Scottish Patient Safety~     Programme (SPSP) to reduce healthcare associated infections (HAls). This is being done~     through implementation of care bundles. Ensuring that ICU patients get the correct amount~     of sedation (medicine that makes patients sleepy) is part of this bundle, but is proving the~     most difficult to get right. It's important healthcare staff (nurses and doctors) get~     sedation levels correct because too much sedation is linked with increased hospital acquired~     infections (HAIs), longer intensive care (ICU) and hospital stays, and possibly higher death~     rates. This quality improvement project will develop and introduce three interventions that~     may improve sedation practice: first, an ICU sedation education package; second, feedback of~     sedation-related performance data (graphs and charts); and third, introduction of a CE~     (Conformité Européenne - With the CE marking on a product, the manufacturer ensures that the~     product conforms with the essential requirements of European regulations) marked new~     technology designed to improve sedation management. The investigators will study the effect~     these interventions, in different combinations, have on sedation management and quality in~     the participating ICUs. Eight ICUs in Scotland will take part in the project, pairs (2 ICUs)~     will be assigned randomly to different combinations as follows: 1.Enhanced education alone,~     2. Education plus process/outcome measure feedback (graphs and charts), 3. Education plus~     introduction of a new sedation monitoring technology, or 4. Education,process/outcome measure~     feedback, and sedation monitoring technology. The investigators will evaluate which~     combinations of education, feedback, and technology provide the most patient benefit in the~     NHS. In addition both nursing & medical staff will be observed in clinical practice &~     interviewed about their clinical practice to increase understanding about sedation management~     from different view points and inform the education package content. These data will also~     help implement the findings after the research is completed if a benefit is found.~   "
147603|NCT01634438|"~     At present, coronary angiogram is usually performed either through an artery in your groin or~     wrist. An important limitation of the wrist approach is an increase rate of blockage of the~     wrist artery. It is possible that the dose of blood thinner (i.e. heparin) may decrease the~     risk of blockage. Early studies seem to suggest that higher dose is required to reduce the~     risk of this important complication. However, to date there has not been a definitive study~     to determine the most appropriate heparin dose for the prevention of this complication. The~     main goal of this study is to determine the appropriate heparin dose to prevent wrist artery~     blockage and to determine risk factors for developing such a complication.~   "
147604|NCT01634425|"~     The purpose of this study is to determine if early diagnosis and risk stratification acquired~     through pre-hospital clinical assessment, 12-lead electrocardiogram and point of care~     biomarkers will facilitate enhanced triage and treatment in patients with presumed non-ST~     elevation acute coronary syndromes (NSTEMI).~   "
147605|NCT01634412|"~     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for~     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for~     bedtime use. The present trial is designed to assess the safety and tolerability of~     sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in~     increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1~     and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and~     cyclobenzaprine (5 mg tablets, or 2.4 mg iv).~   "
147606|NCT01634399|"~     Objective:~      Primary objective of the present study was to compare the single dose bioequivalence of~     Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the study were separated~     by a washout period of 7 days.~      Study Design:~      Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study~   "
147607|NCT01634386|"~     Objective:~      Primary objective of the present study was to compare the single dose bioequivalence of~     Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the fed were separated by~     a washout period of 7 days.~      Study Design:~      Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study~   "
155400|NCT01532128|"~     The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline~     pharmacokinetics in healthy subjects.~   "
147610|NCT01634347|"~     The treatment involves administering propranolol, a medication indicated for treating high~     blood pressure. Propranolol is hypothesized to reduce the strength of drug or alcohol~     cravings (an integral factor involved in relapse), specifically when memories of substance~     use are recalled. In this study, propranolol or a placebo will be administered to patients~     participating in a drug or alcohol rehabilitation facility once a week over three or six~     weeks. After receiving propranolol or placebo, strong memories associated with substance~     craving are recalled by asking participants to read aloud a summary of a substance use~     experience. The investigators hypothesize that participants who receive propranolol will~     report fewer and less intense drug or alcohol cravings than participants who receive the~     placebo or treatment-as-usual.~   "
147611|NCT01634334|"~     The purpose of this study is to determine if real-time feedback (lights/sounds) from small~     smoke particle monitors and brief coaching will encourage parents to reduce young children's~     secondhand tobacco smoke exposure in their home.~   "
147612|NCT01634321|"~     The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot~     Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.~   "
147613|NCT01634308|"~     The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP~     compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor~     augmentation.~   "
147614|NCT01634295|"~     The aim of present study is to evaluate the efficacy and safety of two dose combination of~     S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) compared with S-Amlodipine~     monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.~   "
147615|NCT01634282|"~     The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in~     patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate~     the efficacy of OPC-262~   "
147616|NCT01634269|"~     The primary objective of the present trial is to demonstrate the effectiveness of the~     MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic~     annuli and deemed difficult for surgical operation.~   "
147617|NCT01634256|"~     The investigators performed a double-blind parallel study in a group of showing mild hepatic~     injury subjects who were given Fermented turmeric over a period of 12 weeks. The~     investigators measured liver function parameters , including ALT(Alanine Transaminase),~     AST(Aspartate Transaminase), ALP(Alkaline Phosphatase), γ-GT(Gamma-Glutamyl Transferase), and~     serum bilirubin, and monitored their blood pressure.~   "
147618|NCT01634243|"~     The primary objective of this trial is to establish the maximum maintenance dose of SPM 962~     in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by~     conducting safety evaluation of each patient following once-daily transdermal doses of SPM~     962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard~     8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation~     period) Exploratory evaluation of each patient's maintenance dose will also be conducted with~     attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will~     also be examined.~   "
147619|NCT01634230|"~     This study is in patients with acute liver failure who are not responding to standard of~     care.~   "
147620|NCT01634217|"~     This is a phase I single center dose escalation study with an extension at the best available~     dose to determine the tolerability of inducible regulatory T cells (iTregs) when given to~     adult patients undergoing non-myeloablative HLA-identical sibling donor peripheral blood stem~     cell (PBSC) transplantation for the treatment of a high risk malignancy. Up to 5 dose cohorts~     will be tested. Once the tolerable dose is determined for iTregs, enrollment will continue~     with an additional 10 patients using sirolimus/Mycophenolate mofetil (MMF) graft-versus-host~     disease (GVHD) prophylaxis to gain further safety information and to provide pilot data in~     this treatment setting.~   "
147621|NCT01634204|"~     Since overweight and obesity, a risk factor for various diseases, is a prevalent problem in~     the modern society, it is important to search for new strategies to counteract this. In~     contrast to in person support, the internet provides a low cost opportunity, which is able to~     reach a large part of the population. Therefore a web-based weight loss program may be an~     adequate mean for many people. Now it is hypothesised that a web-based weight loss program is~     able to support a reduction of body weight and weight-related cardiovascular risk factors~     effectively and to promote a healthier lifestyle. It is expected that program use, compared~     to a control group, results in greater reductions in body weight and cardiovascular risk.~   "
147622|NCT01634191|"~     The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics,~     and the safety of a single oral dose of 30 mg of apremilast in healthy subjects.~   "
147623|NCT01634178|"~     The purpose of the study is to evaluate the effects of a high fat meal on the~     pharmacokinetics of a single dose of 30 mg of apremilast in healthy subjects.~   "
147624|NCT01634165|"~     This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There~     will be at least 6 days between each injection.~      The study will compare LY2963016 to Lantus at two different doses.~      This study is approximately 10 weeks long, not including screening. Screening is required~     within 4 weeks of the start of the study.~   "
147625|NCT01634152|"~     The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation~     solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over~     12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children~     (6 to 11 years old) with severe persistent asthma.~   "
147626|NCT01634139|"~     The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation~     solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over~     48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent~     asthma.~   "
147648|NCT01633853|"~     It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the~     Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3~     (Rocaltrol) in the patients with CKD stage 3-5.~   "
147649|NCT01633840|"~     This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be~     used in blinded low-dose food challenges.~   "
150859|NCT01591863|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of~     fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).~   "
147627|NCT01634126|"~     Colorectal cancer (CRC) is a leading cause of cancer death in the United States. Screening~     for CRC reduces CRC mortality, yet rates of screening in the United States remain low. Fecal~     occult blood testing (FOBT) has an established positive balance of benefit and risk, is the~     least expensive, and is the preferred method for nearly half of patients. A newer fecal~     screening test, the fecal immunochemical test (FIT), offers significant improvements over the~     FOBT. It is easier to use and is more sensitive at detecting both CRC and precancerous~     adenomas than the FOBT. The OC-Micro FIT is of particular interest because it is highly~     sensitive and specific and it is the only FIT test approved in the US that can be processed~     in an automated manner. Thus, the OC-Micro is an optimal method for use in mass screening~     programs to improve community CRC-screening rates. However, prior studies of OC-Micro suffer~     from several limitations: they were conducted in populations not optimal for assessing~     screening performance in average risk patients in the U.S. and the studies did not clearly~     establish optimal number of samples required and cut-points for test positivity. Therefore,~     the overall goal of MY-FIT is to capitalize on the highly integrated and extensive electronic~     medical record system of the study site to collect two separate sets of data that, when~     synthesized, will provide a thorough picture of the comparative patient adherence to,~     sensitivity, specificity, and costs of different protocols for using the OC-Micro FIT.~     Specifically, among KPNW members aged 50-75 who are at average risk for colorectal cancer~     (CRC) and who are due for CRC screening (n=78,000), the investigators propose to:~        1. Compare the sensitivity, specificity, positive predictive value, and negative predictive~          value for colorectal cancer and advanced adenoma (advanced neoplasia) between a~          single-sample FIT (1-FIT) and a two-sample FIT (2-FIT) using varying cut points for a~          positive test (n=2100).~        2. Compare patient adherence to completion of a 1-FIT versus a 2-FIT protocol (n=3000).~        3. Assess and compare cost per screen for a 1-FIT versus a 2-FIT protocol, and the cost per~          advanced neoplasia detected in a 1-FIT versus a 2-FIT protocol (using varying cut points~          for a positive test) (n=78,000).~      Answering the above questions will provide a much-needed strong evidence base for a~     best-practice, cost-effective method of using the OC-Micro FIT to screen for CRC in a general~     U.S. population.~   "
147628|NCT01634113|"~     The primary objective of this trial is to evaluate the safety and efficacy of two doses of~     tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the~     afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled~     corticosteroid (ICS) treatment.~   "
147629|NCT01634100|"~     The objectives of the trial are to investigate the effect of concurrent administration of~     rifampicin and probenecid on the pharmacokinetics of empagliflozin.~   "
147630|NCT01634087|"~     This is a study of INCB039110 in patients with chronic plaque psoriasis. This study will~     evaluate safety and efficacy parameters of INCB039110.~   "
147631|NCT01634074|"~     The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep~     therapy device.~   "
147632|NCT01634061|"~     This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone~     acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.~   "
147633|NCT01634048|"~     Obesity is a major problem worldwide and current dietary interventions are not proving to be~     enough to cease the increase in levels of obesity and its detrimental side effects, such as~     nonalcoholic fatty liver disease (NAFLD).~      Existing data suggests that adjustments in the macronutrient composition of the diet, more~     specifically the protein content, may have beneficial effects on body composition and an~     antiobesegenic effect on appetite. This may be important in terms of controlling body weight~     and reducing the amount of fatty tissue within our bodies and organs, and therefore~     preventing obesity and its health related side effects.~      The investigators will perform a study to investigate whether a high protein low energy diet~     compared to a normal protein low energy diet, in overweight adults can modify appetite and~     aid loss of weight and fat mass. Subjects will receive either a high protein low energy diet~     (1.34g protein/kg body weight) or a normal protein low energy diet (0.8g protein/kg body~     weight) in the form of 2 meal replacements and one conventional meal per day with 2 snacks~     for 12 weeks.~      HYPOTHESIS In overweight subjects with the metabolic syndrome, a 12 week dietary intervention~     with a high protein low energy diet will lead to a reduced appetite, body weight and fat~     mass, more specifically to a greater fall in levels of fat in the liver and pancreas than a~     low energy normal protein diet.~   "
147634|NCT01634035|"~     The investigators are studying the correlation between Hba1c and the mean plasma glucose in~     diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess~     glycemic control over a 3 months duration in hemodialysis patients~   "
147635|NCT01634022|"~     Acupuncture is a popular complementary/alternative therapy that has been in use for thousands~     of years for the treatment of various medical and psychiatric conditions, including Major~     Depressive Disorder (MDD). In this study, the investigators applied the investigators~     acupuncture-treatment-for-depression protocol, based on Traditional Chinese Medicine (TCM)~     principles for treating MDD, to depressed patients not taking any antidepressant medications~     (a protocol that the investigators previously piloted as a medication augmentation therapy~     for partial responders with MDD).~      The investigators specifically investigated the efficacy, safety, and tolerability of this~     TCM-based protocol for such patients, as well as potential differences in outcomes between~     weekly vs. twice-weekly treatment. The investigators hypothesized that acupuncture~     monotherapy would be associated with a response rate of at least 50%, which the investigators~     defined as a decrease in depressive symptoms from the beginning to the end of the study of~     50% or more, and that the response would be greater among patients who received acupuncture 2~     times per week (vs. 1 time per week). The investigators also hypothesized that acupuncture~     would be associated with minimal side effects.~   "
147636|NCT01634009|"~     SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional~     edema is an important cause of death in children globally including Bangladesh. The death~     rate among children hospitalized for SAM is still high. Severe malnutrition in children can~     be successfully treated by using WHO guidelines with or without minor modification. Since the~     Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for the~     treatment of children with SAM has gained ground, and huge amounts of RUTF are used~     particularly in African countries. RUTFs are an energy-dense lipid paste enriched with~     vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole milk~     powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix 1.6%.~     Although the CTC model promises treatment of SAM at a considerably lower cost than the~     previous inpatient model, the cost of RUTF is still considered a significant barrier to~     universal roll-out of SAM treatment and has made CTC implementation too expensive in many~     high-need countries.~      The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of~     raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy~     protein has a cost per kg protein that normally is below that of skim or whole milk powder,~     and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a high~     quality, complete protein that meets the daily protein requirements of growing children and~     adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile that~     has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of~     1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when fed~     as the sole protein source at minimum recommended intake levels.~      To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of~     the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked~     intervention trial 300 SAM children aged 6 to 59 months after completion of their~     stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will~     randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving~     -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit at~     the outpatient department of this Dhaka Hospital of icddr,b.~   "
147637|NCT01633996|"~     In this research study, the investigators piloted a uniform acupuncture treatment protocol~     among adults with depression who were taking an antidepressant medication that was providing~     only partial or no symptom alleviation. The study's aims were evaluate the efficacy, safety,~     and tolerability of acupuncture augmentation treatment among this population. The~     investigators hypothesized that acupuncture as an augmentation treatment would be associated~     with a response rate of at least 50%, which the investigators defined as a decrease in~     depressive symptoms from the beginning to the end of the study of 50% or more, and that the~     response would be greater among patients who received acupuncture 2 times per week (vs. 1~     time per week). The investigators also hypothesized that acupuncture would be associated with~     minimal side effects.~   "
147638|NCT01633983|"~     Central serous chorioretinopathy (CSC) is a disease of unknown origin however multiple~     reports have indicated correlation of appearance of CSC with exposure to exogenous or~     elevated levels of endogenous corticosteroid. Since the level of endogenous corticosteroids~     is upregulated in many inflammatory conditions, control of the inflammation may be beneficial~     in reducing this level thus eliminating the stimulus for CSC. Methotrexate (MTX) is widely~     used to control different types of inflammation. The investigators are going to try an~     escalating doses of MTX to treat CSC under full medical supervision.~   "
147639|NCT01633970|"~     This open-label, Phase Ib study that has six treatment arms is designed to assess the safety,~     pharmacology and preliminary efficacy of atezolizumab (MPDL3280A; an engineered~     anti-programmed death-ligand 1 [PDL1] antibody) administered with bevacizumab (Arm A) and~     with bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (FOLFOX) (Arm B),~     with carboplatin and paclitaxel (Arm C), with carboplatin and pemetrexed (Arm D), with~     carboplatin and nab-paclitaxel (Arm E), and with nab-paclitaxel (Arm F) in participants with~     locally advanced or metastatic solid tumors. The study includes dose escalation cohort for~     establishing the maximum tolerated dose (MTD) or maximum administered dose (MAD) and then~     expansion cohort will be initiated based on a selected dose level at or below the MTD or MAD.~   "
147640|NCT01633957|"~     Until very recently, warfarin is still the best drug of choice for long-term anticoagulation~     for patients with mechanical prosthetic heart valve. However, the complication of warfarin~     account for 75 percent of the whole complication after the mechanical prosthetic heart valve~     replacement.~      Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models~     using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2)~     explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have~     the potential to improve patient safety by reducing or eliminating serious adverse events.~     The investigators conducted a prospective, randomized, blinded, two arm trial to test this~     hypothesis.~   "
147641|NCT01633944|"~     The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is~     effective in treating opioid-naive subjects, with moderate to severe chronic low back pain~     (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of~     time.~   "
147642|NCT01633931|"~     The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat~     patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.~   "
147643|NCT01633918|"~     The purpose of this study is to find out whether an Internet-supported FeetEnergy approach~     and two home works integrated in three health education lessons can increase adolescents'~     active commuting to school and leisure-time physical activity and decrease their screen time.~   "
147644|NCT01633905|"~     Alcohol-dependence is the most widespread addiction in Western countries and leads to a wide~     range of impairments at cerebral and cognitive levels. It has also been showed that~     alcohol-dependence is associated with emotional disturbances, particularly for the decoding~     of emotional facial expressions (EFE). In view of the crucial role played by EFE to develop~     and maintain satisfactory interpersonal relations, this emotional processing impairment may~     have deleterious consequences on alcohol-dependent patient's social well-being, and this~     deficit is thus of particular clinical interest. Nevertheless, this deficit has up to now~     been evaluated only by means of experiments using paradigms with low ecological value (i.e.~     presentation of EFE in isolation and in the central vision field), while in the real life,~     emotional stimuli are most frequently appearing together with other emotional stimulations~     (particularly voices) and in the peripheral vision field. Moreover, the cerebral correlates~     of this emotional deficit are still to be determined.~      The present study thus aims at exploring the Emotional Facial Expressions (EFE) decoding in~     alcoholism using a more ecological paradigm, based on peripheral presentation of emotional~     crossmodal stimuli (i.e. the simultaneous presentation of emotionally congruent face and~     voice).~      Main aim: Determining the electrophysiological characteristics (latencies and amplitudes) of~     the event-related components elicited among recently detoxified alcohol-dependent~     participants, while performing an emotion-detection task on crossmodal stimuli (voices and/or~     faces) presented centrally or peripherally, and comparing these characteristics with those~     obtained among paired healthy participants.~      Secondary objectives:~        -  Exploring the electrophysiological pattern modifications among alcohol-dependent~          participants for the emotional faces and voices decoding (unimodal conditions), using~          spatio-temporal analyses methods.~        -  Exploring the electrophysiological waves associated with peripheral crossmodal stimuli~          processing among healthy participants.~        -  Exploring the behavioral correlates (reaction times and accuracy) of the~          emotion-detection task among alcohol-dependent participants while processing peripheral~          stimuli.~        -  Exploring the psychopathological comorbidities among alcohol-dependent participants and~          their influence on the behavioral and electrophysiological results.~   "
147645|NCT01633892|"~     Traumatic facial injuries, especially those sustained in military combat, are characterized~     by destruction of bone and soft tissue. While the bony structures of the face can be~     reconstructed, it is difficult to return the soft tissue back to its original form. Many~     times, fat grafting, a common cosmetic and reconstructive procedure, is used in hopes of~     improving the soft tissue deformity. Fat grafting is a procedure in which a person's own fat~     is taken from areas throughout the body, usually the thighs or abdomen, with a small~     liposuction tube. The fat is then transferred into the area that has lost volume or fullness.~     The fullness of the soft tissue area may decrease over time because the transferred fat can~     be reabsorbed by the body. Altering the current fat grafting procedure, slightly, could lead~     to less reabsorption and a lasting fullness of the soft tissue area outcome of the fat graft~     procedure.~      The investigators are conducting this research study to help us improve the surgical~     treatment of people who have suffered facial soft tissue loss as a result of trauma. The goal~     of this research study is to see how each person's fat grafts will maintain the fat over time~     and to measure the quality of life during a 9 month post-surgical follow-up period. The total~     duration of participation is approximately 11-12 months. In this study, the investigators~     will concentrate the fat in the fat grafting procedure to determine whether this process will~     maintain the fat over time. The areas treated with enhanced fat grafts will be compared with~     areas treated with standard of care fat grafts. At least two areas of your face will be~     treated with fat grafts, (standard of care fat grafts and concentrated fat grafts).~      This study is the second of two clinical studies at the University of Pittsburgh using each~     person's fat graft with concentration of fat cells in the graft to observe if there is less~     fat resorption compared to using fat grafts alone. Each study is using a different~     concentration of fat in the fat graft compared to the first clinical study.~   "
147646|NCT01633879|"~     This study tests the effectiveness of the bilingual Health and Success program, which aims to~     support Latino parents and schools in their efforts to promote the academic success and~     healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of~     HIV/AIDS in urban Latino communities.~   "
147647|NCT01633866|"~     The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil~     magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center~     (CCHMC).~   "
147650|NCT01633827|"~     In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep.~     This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an~     increased risk for developing high blood pressure. Currently, the best treatment for~     obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose~     (i.e. Continuous positive airway pressure [CPAP] treatment). While CPAP treatment stops the~     upper airway from closing in most people, many people have difficulty sleeping with the mask~     in place and therefore do not use the CPAP treatment. This research study is being conducted~     to learn whether using a combination of therapies (i.e. a sedative and oxygen therapy) will~     improve OSA severity by altering some of the traits that are responsible for the disorder.~   "
147651|NCT01633814|"~     Older women have an exaggerated increase in blood pressure during exercise. However, the~     reasons for this are unclear. It is important to investigate this phenomenon because a~     greater blood pressure response to exercise has been associated with an increased risk of~     stroke and mortality in otherwise healthy individuals. A unique aspect of aging in women is~     the profound change in hormone levels (i.e. estrogen and progesterone) associated with~     menopause. The influence of changes in estrogen and progesterone levels on the cardiovascular~     responses to exercise is poorly understood. However, it has been suggested that these~     hormones might change the responsiveness of the cardiovascular system. Possible mechanisms~     that could account for these changes are the arterial baroreflex and feedback from the~     exercising muscle (known as the exercise pressor reflex), both of which are known to~     powerfully modulate blood pressure during exercise. However, to date, few human studies have~     thoroughly examined the influence of changes in hormone levels on baroreflex function during~     exercise or the exercise pressor reflex in older women. As such, the purpose of this research~     project is to assess baroreflex function and the exercise pressor reflex in older women after~     transdermal estrogen and placebo.~   "
147652|NCT01633801|"~     Humidified high flow nasal prong oxygen therapy is a method for providing oxygen and CPAP.~     The delivery of high flows decreases dilution of the inhaled oxygen and, by matching~     patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole~     inspiratory phase. In addition, a flow-dependent effect of continuous positive airway~     pressure, possibly due to an air entrainment mechanism, has been documented in healthy~     volunteers and in patients with COPD.~      The investigators working hypothesis is that the use of post-extubation CPAP delivered via~     nasal cannulae in infants less than 18 months, post-bypass surgery will have better PaCO2~     values than infants extubated on to oxygen therapy.~   "
147653|NCT01633788|"~     This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in~     patients with meibomian gland dysfunction (MGD) in the eyelids.~   "
147654|NCT01633775|"~     The purpose of this study is to compare three-year outcomes of re-trabeculectomy with those~     of Ahmed glaucoma valve implantation in secondary surgical management of patients with~     primary open angle glaucoma (POAG) and a history of previous failed trabeculectomy.~   "
147655|NCT01633762|"~     The aim of the study is to assess the effect of eradication of gut microbiota on 1) glucose~     metabolism including postprandial plasma responses of the incretin hormones GIP and GLP-1,~     insulin, C-peptide and glucagon, 2) metabolomic profiles and resting energy expenditure (REE)~     3) appetite, satiety, food intake, gastric emptying and gall bladder emptying, 4) levels of~     markers of bone formation and resorption as well as serotonin, 5) markers of systemic~     inflammation, and 6) on the (prospective) composition of bacteria in faeces, blood and~     saliva. Thus, the overall objective is to provide detailed knowledge on the physiological~     role of gut microbiota combined with bioinformatic analyses of the functional implications of~     changes in bacteria composition on the level of both species and phylum.~   "
147656|NCT01633749|"~     Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013~     season for the prevention of influenza infection. The immunizing effect is being~     investigated, as well as its tolerability and safety.~   "
147657|NCT01633736|"~     This study's main aim is to look at targeted strength training for muscles at the hips.~     Specifically to consider whether targeted strength training not only effects strength of the~     specific muscles but also ability to stand on one leg (single leg balance) as well as walking~     in children with cerebral palsy? This study is a feasibility of method of investigation.~   "
147658|NCT01633723|"~     DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled,~     single/multiple dosing, dose escalation clinical trial with open-labelled food effect study~     of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after~     oral administration in healthy male subjects.~   "
147659|NCT01633710|"~     The study will compare Padd, a non-invasive automated optical device which uses a functional~     test to assess peripheral arterial disease (PAD), and Ankle brachial pressure index (ABPI) in~     the detection of PAD using as a gold standard, colour duplex ultrasound, in participants~     drawn from general practice, a hospital diabetic clinic and a tertiary vascular disease~     referral centre. The study hypothesis is that Padd performs at least as well as ABPI in~     detecting PAD.~   "
147660|NCT01633697|"~     The investigators hypothesize that education will improve exercise capacity, symptoms and~     quality of life in patients with chronic obstructive pulmonary disease (COPD). In addition,~     the investigators are interested in determining how education might alter various chemicals~     in the blood and exhaled breath that reflect inflammation in the lungs and the body as a~     whole.~      The investigators plan to enroll 42 patients into this study, with half of them participating~     at each of the two sites, Vermont Lung Center at the University of Vermont in Burlington,~     Vermont, and at Baylor College of Medicine in Houston, Texas. Participants will undergo a~     series of measurements and tests at the beginning of the study, receive formal education~     about COPD over the next 2 weeks, return at 6 weeks for a brief refresher session, and~     finally return after 12 weeks for repeat measurement and testing as was done at the~     beginning. Participants will be asked to keep a diary of symptoms, medication, and exercise~     during the study.~   "
147671|NCT01633554|"~     IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33~     has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We~     aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.~   "
147839|NCT01631357|"~     This randomized, open-label phase II/III study is to evaluate the effects of chemotherapy~     combination with autologous cytokine-induced killer Cell immunotherapy in patients with stage~     IIIb-IV squamous non-small-cell lung cancer~   "
147661|NCT01633684|"~     Because the diabetics are fracturing at a younger age than the general population (12), this~     leads us to believe there are significant factors that lead to fracture in Type 1 diabetes~     mellitus (DM) other than bone mineral density (BMD). Very little longitudinal data exists on~     BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data~     exists on pQCT in adults with Type 1 DM.~      Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral~     density (BMD) as measured by DXA compared to age and sex matched healthy controls.~   "
147662|NCT01633671|"~     In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care unit~     (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers were~     measured according to the standard hospital protocol. To definitively confirm or exclude APE,~     all patients underwent an angiographic CT-scan of the thorax.~   "
147663|NCT01633658|"~     The investigators hypothesize that native vitamin D will have more variability in 25(OH)D~     dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be~     a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500~     μg native vitamin D given orally.~   "
147664|NCT01633645|"~     The primary objective of this study is to establish the objective response rate (complete~     response + partial response) following treatment with VELCADE in combination with cisplatin~     plus gemcitabine in patients with locally advanced (Stage IIIb) or metastatic (stage IV~     non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for~     advanced disease~   "
147665|NCT01633632|"~     The purpose of this study is to determine whether Hatha Yoga can improve the chances of a~     successful smoking quit attempt.~   "
147666|NCT01633619|"~     The incidence of postoperative PJI is ranging from 0.5-2.5% for primary interventions and are~     reported up to 20% for revision procedure. In addition, hematogenous PJI can occur at any~     time after implantation and the risk of infection remains during the entire prosthesis~     indwelling time. Prosthetic joint infections (PJI) are associated with significant morbidity~     and costs to the healthcare system. Evidence for optimal management of PJI with best outcome~     and lowest expenses is limited and recommendations between countries vary significantly.~     There is unmet need to standardized diagnostic procedures and definition of infection as well~     as achieve a consensus for uniform treatment guidelines.The European Implant Cohort Study~     (EICS) is a multicenter European research project, including patients with PJI in a cohort~     representative for Europe. The EICS is established jointly by the Orthopedic and Traumatology~     surgeons, Infectious Diseases specialists and microbiologists of selected university and~     non-university institutions across Europe. The principal aim of the EICS is to improve the~     management of PJI and develop consensus guidelines across Europe. By systematic analysis of~     consecutively included patients with PJI, factors associated with best outcome regarding~     infection (assessed by the infection-free interval) and joint function (assessed by the~     degree of pain, mobility, range of motion) will be determined in a longitudinal prospective~     study with long-term follow-up. This is an investigator-initiated, open, prospective,~     multicenter observational study. Participating study centers will be university or~     non-university hospitals across Europe, which fulfill the following study conditions:~        -  Close collaboration between infectious diseases specialists, microbiologists and~          orthopedic/trauma surgeons,~        -  Availability of appropriate microbiological methods (following standard recommendations~          including sonication of removed prosthesis),~        -  Availability a dedicated study team (study nurse and/or research fellow) for regular~          eligibility screenings, patient inclusion procedure, real-time data collection and~          patient follow-up.~      This project may generate important scientific evidence for future guidelines regarding~     management of PJI, has the potential to initiate new multicenter substudies in an establish~     network, and may open further collaboration and exchange of skills between institutions~     across Europe.~   "
147667|NCT01633606|"~     The aim of the study is to develop a screening instrument, based on the nursing activities~     score, by which we can distinguish medium care patients from the intensive care patients in~     terms of nurse staffing.~      The main study question is: What is the most discriminative NAS cut off for medium care~     patient?~      Each nursing shift the NAS and TISS 28 scores will be calculated for each patient who is~     admitted to the 8 participating units.~      Nurses will be asked to answer 3 questions (see detailed description here under)at the end of~     their working shift concerning each patient appointed to them.~      Each morning medical staff and head nurses will be asked 2 questions (see detailed~     description here under) for concerning patient admitted to there ward.~      In order to determine the NAS cut off for medium care patient, all morning questionnaire~     scores will be compared to the NAS an TISS28 scores of that same morning.~      Secondary study questions are:~        -  Can NAS score based on one nursing shift predict the severity of care in the subsequent~          nursing shift?~        -  Is there a difference in appreciation of severity of care between nurses, head nurses~          and medical staff?~        -  Which variables influence the perception of severity of care?~        -  How does NAS relate to TISS28, APACHE and NEMS?~   "
147668|NCT01633593|"~     Nowadays features for the diagnosis of delirium are:~        1. Disturbance of consciousness (i.e. reduced clarity of environment awareness) with~          reduced ability to focus, sustain or shift attention;~        2. A change in cognition (such as memory deficit, disorientation, language disturbance) or~          the development of a perceptual disturbance that is not better accounted for by a~          pre-existing or evolving dementia;~        3. The disturbance develops over a short period of time (usually hours to days) and its~          severity fluctuates during the course of the day;~        4. There is evidence from the history, physical examination, or laboratory findings that~          the disorder is caused by the direct physiological consequences of a general medical~          condition, substance intoxication or substance withdrawal.~      Treatment of underlying clinical disease is important to remit the delirium. However, these~     procedures alone are not enough to remit the delirium early and to prevent sequels. There is~     a need for a specific and faster strategy to treat the delirium.~      The investigators want to test the hypothesis that an Anticholinesterase Inhibitor~     (donepezil) can reduce the duration of the delirium.~   "
147669|NCT01633580|"~     The purpose of the present study is to analyse if corifollitropin alfa, an agent for~     prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day~     2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.~   "
147670|NCT01633567|"~     For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living~     in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown~     great promise in reducing health risk behaviors across a variety of behaviors and population~     groups by enhancing the relevance of the health information. The primary aim of this study is~     to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs.~     a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and~     transgender (LGBT) smokers. The investigators anticipate that the culturally targeted~     intervention will be more effective at helping LGBT smokers to successfully stop smoking than~     will the non-targeted intervention.~   "
153352|NCT01559077|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of a single dose of ALN-TTR02 in healthy volunteer subjects.~   "
147672|NCT01633541|"~     To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction~     chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for~     the treatment of advanced cancer. It is hoped that the combination of this chemotherapy~     regimen will allow cancer patients to keep their voice box and to improve/maintain~     voice-related quality of life. The ultimate goal of this study is to prevent the surgery to~     remove subjects voice box.~   "
147673|NCT01633528|"~     It has been reported that low-dose aspirin and Heparin would lead to an increased Pregnancy~     rate in patients undergoing IVF-ET. Low-dose aspirin may improve uterine and ovarian~     perfusion and that aspirin might enhance endometrial receptivity and ovarian responsiveness~     as well, which could result in better implantation and pregnancy rates after IVF or ICSI~     treatment. This study assesses potential effects of low-dose aspirin (100 mg daily) on~     pregnancy rate following frozen embryo transfer.~   "
147674|NCT01633515|"~     A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the~     elderly utilizing intralesional cryosurgery.~      10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo~     intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus~     the BCC is frozen. Treatment success will be determined according to biopsy results 3 months~     after treatment~   "
147675|NCT01633502|"~     Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite~     rapid invasive treatment, circulatory support using positive inotropes and mechanical support~     with intra-aortic balloon counterpulsation (IABP), and evaluation of several new treatments~     during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%.~     An alternative to current management is restoration of the volume of blood pumped by the~     heart (cardiac output) using a ventricular assist device. In the acute setting this is~     difficult but can be done using the Impella device which is a catheter-based, axial flow pump~     that pumps blood directly from the left ventricle into the circulation thereby restoring~     blood flow to the failing organs. In 2012 a more powerful Impella has been introduced that is~     able to deliver 3.5l/min (approximately 75% of a normal cardiac output). The hypothesis of~     the current study is to reduce mortality and morbidity of patients with cardiogenic shock~     using the Impella cVAD. The study will be carried out as a randomized multicenter study where~     eligible patients will be randomized to receive conventional circulatory support or support~     with the Impella device and inotropic support if needed. A total of 360 patients are planned~     to be enrolled, and the primary endpoint will be death.~   "
147676|NCT01633489|"~     This is an observational, multi-center, international disease registry designed to collect~     longitudinal data and create a knowledge base that will be utilized to improve the care and~     treatment of patients with LAL Deficiency. Participation in the Registry by both physicians~     and patients is voluntary.~   "
147677|NCT01633476|"~     The purpose of this study is to determine whether Cytomegalovirus (CMV) reactivation in~     ANCA-associated vasculitis (AAV) patients can be effectively and safely reduced using an~     antiviral agent (valaciclovir) and whether this in turn improves the function of the immune~     system thereby also improving the body's ability to fight other infections.~      The primary hypothesis is that repeated episodes of CMV reactivation in AAV patients drive~     the expansion and functional impairment of CMV-specific T-cells, with increased~     susceptibility to infection. Inhibition of CMV replication with valaciclovir will block~     further stimulation of CMV specific T-cells and increase the functional capacity of the~     immune system.~   "
147678|NCT01633463|"~     EMERGENCY CANCER PAIN DRAWS CANCER PATIENT TO EMERGENCY DEPARTMENT FOR TREATMENT. HOWEVER,~     THERE HAS BEEN INCONSISTENCY AND INADEQUACY OF PAIN MANAGEMENT IN EMERGENCY DEPARTMENT. THIS~     STUDY OBSERVES THE STATUS OF PAIN ASSESSMENT AND ITS ADEQUACY IN EMERGENCY DEPARTMENT IN A~     TERTIARY CARE CANCER HOSPITAL.~   "
147679|NCT01633450|"~     One of the newest strategies to combat micronutrient deficiencies is the biofortification of~     staple foods, where higher levels of minerals are obtained through breeding of staple crops.~     The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when~     compared with a control rice fortified with zinc just before consumption.~   "
147680|NCT01633437|"~     The objectives of this study were to examine the cardiovascular sensitivity to oral tyramine~     after establishment of steady state with CX157 Modified Release (MR) Tablets, 125 mg~     administered twice per day (BID) in healthy volunteers compared to placebo; and to~     investigate the general safety, tolerability and pharmacokinetic profile of CX157 tablets at~     steady state compared to placebo.~   "
147681|NCT01633424|"~     Given the extremely limited availability of donated organs, transplant candidates must be~     carefully evaluated and selected to ensure the success of the transplant and value of the~     organ to the recipient. Medical criteria for pre-transplant evaluation of patients is well~     established, however, listing criteria for psychosocial risk factors (e.g., understanding of~     illness and transplant process, psychiatric history, support system, compliance, etc) is less~     standardized. The purpose of this research is to study the psychometric properties (e.g.,~     predictive validity) of the new pre-transplant Stanford Integrated Psychosocial Assessment~     for Transplant (SIPAT) examination in patients who received heart, kidney, liver, or lung~     transplant and underwent the SIPAT evaluation before treatment. This new screening tool was~     designed to standardize the evaluation process of psychosocial risk factors and their~     severity, in order to enhance predictions of medical and psychosocial outcomes of patients~     post-transplant.~      If the SIPAT is used for standard, pre-transplant assessment, risk factors that may be~     amenable to clinical intervention could be identified. In turn, this may assist in developing~     a comprehensive psychosocial treatment plan for each individual, with the ultimate goal of~     minimizing preventable problems, mitigating risk, and optimizing graft survival, patient~     function, and quality of life.~   "
147682|NCT01633411|"~     This is a feasibility study without a primary study hypothesis or statistical comparison.~   "
147729|NCT01632800|"~     This study is being conducted to improve magnetic resonance imaging (MRI) scans by reducing~     the time required for imaging. Experience has shown that unpleasant side-effects from~     magnetic pulses used in MRI (for example, tingling or tapping sensations) can be reduced when~     the magnetic pulses are shortened. In this study, we will explore whether this effect holds~     true when very short magnetic pulses are applied.~   "
150462|NCT01597050|"~     The purpose of this study is to determine the safety, efficacy and tolerability of topical~     R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)~     patients with active discoid lesions.~   "
147683|NCT01633398|"~     The ASIAN HF Registry is the first prospective multinational Asian registry of patients with~     symptomatic HF (stage C)11 including both HFrEF (ejection fraction <40%)3 and HFpEF (ejection~     fraction ≥50%), with the broad purpose of determining the mortality (incidence) burden of HF~     in Asian patients, and more specifically to define the burden and risk factors of Sudden~     Cardiac Deaths (SCD), as well as the sociocultural barriers to preventive device therapy. The~     study further aim to study the genetic variants associated with HFrEF versus HFpEF in our~     large Asian cohort.~      This proposed registry is expected to advance fundamental understanding of the burden and~     predictors of preventable death among Asian patients with HF. The knowledge gained will be~     critical for guiding resource allocation and planning preventive strategies to address the~     unmet and growing clinical needs of patients with cardiovascular disease in Asia.~   "
147684|NCT01633385|"~     The investigators plan to study the variability of lung function parameters and bronchial~     inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25 years~     compared with an age- and sex-matched control group. The investigators will perform a~     pulmonary function test (body plethysmography with TLCO), and measure the fraction of exhaled~     nitric oxide (eNO). Further a blood sample is drawn to determine the systemic inflammation.~     Finally induced sputum is collected and a cell count is performed, and cells and supernatants~     are analyzed for inflammatory markers. This investigation will be repeated after 4-6 weeks.~     The aim of this study is to define baseline values and the variability of possible outcome~     parameters for future interventional studies.~   "
147685|NCT01633372|"~     This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will~     evaluate safety and efficacy parameters of itacitinib (INCB039110).~   "
147686|NCT01633359|"~     Hypothesis: Peripheral blood Very Small Embryonic-like Stem Cells (VSELs) are different in~     coronary artery disease (CAD) patients from those without CAD, which might account for the~     benefits of Atorvastatin in CAD patients.~   "
147687|NCT01633346|"~     The purpose of this study is to know the level of expression and activation state of~     different transcription factors of the STAT family (STAT1, STAT3, STAT5A, STAT5B, STAT6) in~     the hematopoietic cells from tocilizumab treated patients.~   "
147688|NCT01633333|"~     Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of~     colonoscopy involving the use of water as the sole modality to aid colonoscope insertion,~     water exchange, has been described in recent research papers to decrease patient discomfort~     and pain, and to reduce the need for sedation during colonoscopy when compared with standard~     air insufflation. Carbon dioxide insufflation has been described to decrease patient~     discomfort after colonoscopy. No randomized trial has so far compared the use of water~     exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less~     discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients~     undergoing screening colonoscopy in two centers in Norway, one center in Poland and one~     center in The Netherlands will be enrolled and randomized to examination of either of the two~     methods.~   "
147689|NCT01633320|"~     The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index~     (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients~     undergoing general anesthesia.~   "
147690|NCT01633307|"~     Aim: to determine whether a nationwide teaching program delivered to medical doctors can~     decrease the use of inappropriate intravenous lines in internal medicine~   "
147691|NCT01633294|"~     The aims of this study are to determine whether antibiotics administered routinely in women~     presenting with premature rupture of membranes later than the 37+0 weeks of gestation can~     alter the rate of maternal and neonatal infection and to compare these rates between prompt~     (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to~     antibiotic prophylaxis.~   "
147692|NCT01633281|"~     A significant proportion (up to 60%) of myeloma patients treated with Bortezomib or~     thalidomide or both develop significant peripheral neuropathy (PN). Standard of care for this~     complication include drugs like gabapentin or pregabalin, which relieve symptoms only~     partially. PN of grade II or above mandates reduction in dose or frequency of Bortezomib or~     thalidomide, which may compromise treatment outcome. This clinical study explores whether, by~     intervening early in its course using acupuncture, progression of PN can be reversed,~     stabilized or retarded thereby allowing continuation of treatment on schedule.~   "
147693|NCT01633268|"~     Objective: In this study we will develop and apply imaging techniques to perform the first~     three-dimensional (3-D) measurements of brain biomechanics during mild head movement in~     healthy human subjects. Biomechanics is the application of mechanics, or the physical~     principles in action when force is applied to an object, to the anatomical structure and/or~     function of organisms. Such techniques will be invaluable for building computational models~     of brain biomechanics, understanding variability of brain biomechanics across individual~     characteristics, such as age and sex, and determining brain sub-structures at risk for damage~     when movement of the head is accelerated, such as during a traumatic event.~      Study Population: Measurements will be performed on 90 healthy men and women aged 18-50.~      Design: We will build upon the model pioneered by our collaborator, Dr. Philip Bayly. The~     model places a human subject in a magnetic resonance (MR) scanner with one of two head~     support units that allows a specific range of motion. Each head support is latched such that~     it can be released by the subject, and results in either a rotation of the head of~     approximately 30 degrees or a flexion-extension of the head of approximately 4 degrees.~     Although both supports are weighted so that the motion is repeatable if the subject is~     relaxed, the subject can easily counteract the weight. The resulting~     acceleration/deceleration is small (in the range of normal activities, such as turning one's~     head during swimming) and has been validated and used in other human investigations of brain~     biomechanics. The subject repeats the motion multiple times during the MR scan under their~     own volition and desired pace to measure motion of the head and brain.~      Outcome measures: This project is a pilot study evaluating the potential of extracting~     three-dimensional estimates of brain deformation, such as strain measurements, using MR~     imaging. A primary outcome of this project will be a fast MR acquisition sequence for~     measuring 3-D brain deformation. The sequence will be evaluated by applying the protocol to~     human subjects, followed by preliminary quantification of the reproducibility and stability~     of deformation measurements.~   "
147723|NCT01632878|"~     The OPTIMISE study is a prospective, multi-center, multi-national, structured data collection~     initiative, first compiling data on the current treatment of post myocardial infarction~     patients (screening-log) and then, prospectively evaluating only those patients being~     prescribed Omacor as part of their standard secondary prevention treatment. The aim is to~     observe the Omacor cohort of patients for a period of 12 months, collecting long term~     observational data as clinical and patient-reported outcomes, especially, but not~     exclusively, recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive~     Heart Failure (CHF). No predefined additional visits, medical tests, labs, procedures or~     interventions will be mandated. Only results from routinely performed tests, labs, procedures~     and/or interventions will be collected if available.~   "
147694|NCT01633255|"~     Background:~      - The experimental contrast agent [18]F-Fluciclatide is being tested for cancer treatment~     imaging studies. It is designed to show tumors in which new blood vessels are growing.~     Imaging studies with [18]F-Fluciclatide may help predict how well a tumor will respond to~     therapy that will prevent the growth of new blood vessels. Researchers will test~     [18]F-Fluciclatide before beginning treatment and after the first treatment cycle.~     Participants may also have a third scan with [18]F-Fluciclatide between 2 and 7 days after~     starting treatment to look for changes in blood vessel growth early after starting therapy.~      Objectives:~      - To test the safety and effectiveness of [18]F-Fluciclatide in predicting cancer treatment~     outcomes.~      Eligibility:~      - Individuals at least 18 years of age who will have kidney cancer treatment to stop tumor~     blood vessel growth.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor imaging studies and biopsies will be performed before~          starting the study.~        -  Participants will have two positron emission tomography (PET) and computed tomography~          (CT) scans. [18]F-Fluciclatide will be used for each scan. One scan will happen before~          the start of cancer treatment, and the second will happen after the first treatment~          cycle.~        -  Participants may also have an optional third PET/CT scan with [18]F-Fluciclatide. This~          scan will take place 2 to 7 days after beginning therapy.~        -  Depending on the location of the tumor, some participants may have an optional magnetic~          resonance imaging scan to look for changes in tumor blood flow and size. These scans~          will be done within 3 weeks of each [18]F-Fluciclatide PET/CT scan.~        -  The scans will be monitored with regular blood tests and vital signs.~        -  Participants will be followed for up to 1 year after the study to look for overall~          disease response to therapy.~   "
147695|NCT01633242|"~     Background:~      - Muscular dystrophy can affect the muscles used for heart function and breathing. Treatment~     usually involves drugs that help improve heart function. However, better types of heart~     imaging studies are needed to improve treatment of heart problems related to muscular~     dystrophy. Better heart imaging methods are especially needed for children with muscular~     dystrophy. Researchers want to test different heart imaging methods in children with muscular~     dystrophy. They will look at cardiac magnetic resonance imaging (MRI) and standard heart~     function tests.~      Objectives:~      - To develop and test new methods for imaging the heart in children with muscular dystrophy.~      Eligibility:~      - Children and adolescents between 8 and 17 years of age who have muscular dystrophy.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will provide a blood sample at the start of the study. They will also have~          heart function tests before having the imaging study.~        -  Participants will have a cardiac MRI scan that will last up to 60 minutes. Some tests~          will require a MRI contrast agent (a drug that helps the image appear more clearly on~          the scan).~   "
147696|NCT01633229|"~     Background:~        -  Bone marrow stromal cells (BMSC) from bone marrow biopsies can be used to treat~          disorders that cause inflammation and immune system diseases. BMSC have been used to~          treat graft versus host disease (GVHD), a complication that can develop after stem cell~          transplants. BMSC have also been used to treat other post-transplant complications, like~          marrow failure or tissue injury.~        -  The National Institutes of Health (NIH) has developed a procedure for collecting and~          preserving BMSC from volunteer donors. These donors have passed tests to ensure that~          their cells are healthy enough to be used for treatment. Researchers want to use the~          collected cells to treat people with GVHD, marrow failure, or tissue injury following~          stem cell transplants.~      Objectives:~      - To test the safety and effectiveness of NIH-collected BMSC to treat complications from stem~     cell transplants.~      Eligibility:~        -  Individuals between 18 and 75 years of age who have complications from stem cell~          transplants.~        -  Complications are acute GVHD, poor bone marrow function, or tissue or organ damage.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have imaging studies and blood tests.~        -  Participants will provide blood, skin, and bone marrow samples before the BMSC~          treatment. Additional samples, including tissue samples, will be collected after the~          start of treatment.~        -  Participants will have up to three BMSC infusions. There will be a week between each~          infusion. Participants will be monitored closely during each infusion. Any side effects~          will be treated.~        -  Treatment will be monitored with frequent blood tests and physical exams.~        -  After the end of the infusions, participants will have regular followup visits for up to~          2 years.~   "
147697|NCT01633216|"~     This randomized clinical trial will assess the immune response in infants following~     administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV~     type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short~     schedule with administration at two week intervals and the usual schedule at four week~     intervals. The results of this study will guide the Global Polio Eradication Program in the~     implementation of new strategies that may: 1) improve the quality of the response to~     outbreaks following importation of wild poliovirus type 1 by shortening the interval at which~     several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3~     poliovirus by using bOPV in outbreak responses in countries with weak routine immunization~     systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the~     replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.~   "
147698|NCT01633203|"~     This study will assess the efficacy and toxicity of perioperative chemotherapy with~     Epirubicin + Cisplatin + Capecitabine (ECX) in routine clinical practice in a network of~     public hospitals in Santiago, Chile.~   "
147699|NCT01633190|"~     -  Rotavirus Hospital Admissions Surveillance~        -  Retrospective surveillance for 2010 and 2011 for hospital admissions in children aged 0~          to 16 years due to rotavirus gastroenteritis will be completed by all centers of the~          IMPACT (Immunization Monitoring Program, ACTive) pediatric hospital network.~        -  Prospective surveillance of rotavirus-related admissions for children aged 0 to 16 years~          was conducted in 2012-14 inclusive and will be performed for an additional three years,~          2015, 2016 and 2017 at all 12 sites. Surveillance methodology will continue using the~          same case-finding strategy and the same case report form as in past surveillance (Case~          reporting is done electronically.~        -  Emergency Department Burden of Disease Case finding for all-cause diarrheal illness~          using ICD codes was undertaken prospectively for 2012 to 2014 and will not continue in~          the years 2015-17 inclusive. Systematic stool sampling was carried out for cases of~          gastroenteritis in children < 5 years of age presenting to the ED departments at the~          IMPACT hospitals in 2012 and 2013 and 5 of the 12 center hospitals in 2014. This~          component will not continue in to the 2015-17 protocol study years. However the admitted~          cases presenting to the IMPACT center hospitals with positive rotavirus will be reported~          and stool samples saved for genotyping at a later date.~   "
147700|NCT01633177|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial~     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among nondiabetic participants in~     VITAL and will examine whether vitamin D or fish oil prevent type 2 diabetes. Findings from~     this proposed study conducted within the VITAL trial will clarify whether vitamin D and~     omega-3 fatty acid supplementation reduces risk of type 2 diabetes and thus will inform~     public health and clinical guidelines for diabetes prevention.~   "
147724|NCT01632865|"~     To evaluate whether recanalization and stenting for symptomatic subacute and chronic~     veterbrobasilar artery occlusion is technically feasible, can prevent from recurrent ischemic~     events and promotes functional recovery of disability.~   "
147701|NCT01633164|"~     The purpose of this study is to evaluate the efficacy of a replicable, psychologically-based~     group education intervention, Re-Inventing Yourself after Spinal Cord Injury (SCI), which~     aims to enhance personal self-efficacy. A structured six-week, manualized, group therapy~     intervention that delivers positive psychology concepts within a cognitive-behavioral~     therapy-based model has been created for the purpose of developing a resilient and optimistic~     sense of efficacy for people with SCI. Concepts covered within this intervention include:~     reframing and restructuring a person's method of looking at events, building confidence by~     focusing on personal strengths, developing methods of recognizing and appreciating the good~     in one's life and expressing gratitude for positive attributes. The goals of this~     intervention are to increase personal self-efficacy, enhance emotional well-being and improve~     participation in society for people with SCI living in the community. The investigators~     hypothesize that persons receiving the intervention will demonstrate improved SCI-specific~     and overall self-efficacy as compared to waitlist controls.~   "
147702|NCT01633151|"~     The purpose of the study is to determine the precision of an unobtrusive sleep measurement~     system. The system measures a force sensor signal under the mattress and analyzes sleep~     quality. The system measures: time in bed, sleep stages, sleep fragmentation, heart rate,~     respiration rate, sleep related breathing disorders, and limb movements.~   "
147703|NCT01633138|"~     The purpose of this study is to investigate whether monetary reinforcement for performance~     will enhance the effects of cognitive remediation therapy for substance users seeking~     treatment at an outpatient facility.~   "
147704|NCT01633125|"~     The prevalence of psychological problems is high in prisons. Many prisoners have unmet needs~     for appropriate treatments. Although pilot studies have suggested music therapy to be a~     successful treatment modality for prisoners, more rigorous evidence is needed.~      This study aims to investigate the effectiveness of group music therapy to improve anxiety,~     depression, and self-esteem in prisoners. One hundred and ninety two inmates from a Chinese~     prison will be allocated to two groups through randomisation. The experimental group will~     participate in biweekly group music therapy for 10 weeks (20 sessions) while the control~     group will be placed on a waitlist. Anxiety, depression and self-esteem will be measured by~     self-report scales three times: before, at the middle, and at the end of the intervention.~     Logs by prisoners and daily behavior observation by trained prison guards will be used as~     additional information.~      This study will increase the knowledge of the effectiveness of group music therapy. Results~     will be generalizable to Chinese prisons but also internationally. Generalizability to~     clinical practice will be high, and findings will be able support the further development of~     music therapy in prison.~   "
147705|NCT01633112|"~     The purpose of this study is to compare 2 doses (0.25 mg and 0.50 mg) of fingolimod to~     glatiramer acetate (20 mg) and to evaluate the efficacy of fingolimod 0.25 mg for the~     treatment of patients with relapsing-remitting MS (RRMS).~   "
147706|NCT01633099|"~     The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine~     in the treatment of elderly Acute Myeloid Leukemia (AML) patients.~   "
147707|NCT01633086|"~     This is a randomized, double-blind, placebo-controlled, 2-period crossover, 12-week trial to~     be conducted in 50 subjects with painful diabetic neuropathy. The objective of this trial is~     to assess the safety and efficacy of NO gel, a NO donor, as compared with a placebo gel, in~     symptom relief of subjects with painful diabetic neuropathy.~   "
147708|NCT01633073|"~     The aim of this randomized prospective study is to compare two single-use laryngeal mask~     airways with a provision of a gastric drain tube allowing for evacuation of gastric contents,~     the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure~     ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not~     be significantly different clinically (higher) when compared with the LMA Supreme.~   "
147709|NCT01633060|"~     This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and~     safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast~     cancer who progressed on or after mTor inhibitor based treatment.~   "
147710|NCT01633047|"~     The anterior cruciate ligament (ACL) is frequently injured, and it is the structure of the~     athlete´s knee which has the highest prevalence of reconstruction. Given this postoperative~     ACL reconstruction scenario the investigator find in literature the effectiveness of~     neuromuscular electrical stimulation (NMES) as an adjuvant treatment for strengthening the~     quadriceps muscle. The intensity of NMES and the training duration are important factors for~     a successful treatment.~      The purpose of this study is to compare two rehabilitation protocols in patients during the~     post operative of the ACL reconstruction over the strength of knee extension and control of~     edema.~      It will be a randomized controlled study with the CONSORT bases with 40 participants that~     will be divided into two groups: Control group that will be submitted only to physical~     therapy exercises, and the Intervention group that will be submitted to physical therapy~     exercises plus electrical stimulation (low frequency device with a current of 47 Hz with~     symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of~     1.8 s). The procedure will last six weeks. It will be evaluated the pre intervention~     quadriceps muscle extension force by means of a manual dynamometer, and the joint swelling~     through the perimeter. This procedure will be repeated after six weeks of intervention.~   "
147711|NCT01633034|"~     The purpose of the research is to collect and examine spinal disc and ligament tissues to see~     if there are any biological markers that can be correlated with MRI images to help us learn~     more about causes of back pain. Spinal discs are the pillow-like cushions between the bones~     of the spine. They act as shock-absorbers for the spine. Spinal ligaments support the disc~     structure during movement.~   "
147725|NCT01632852|"~     This is a first in human, prospective, multicenter, nonrandomized, open-label,~     dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and~     immunogenicity of repeat doses of CSL362.~   "
147726|NCT01632839|"~     The primary objective of this study is the psychometric validation of two questionnaires~     (PISQ-R and a new questionnaire on sexuality) as compared to a non specific questionnaire on~     female sexual function (FSFI).~   "
147727|NCT01632826|"~     To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a~     likelihood of benefit from the pomalidomide treatment while the medication is not~     commercially available~   "
147712|NCT01633021|"~     Background:~      - Knowing one s family medical history is a part of staying healthy. Some health risks run in~     families, and knowing these risks can promote more healthy behavior. Different social and~     cultural factors may affect how family members share this information. Genetic risk~     information that is shared in one family may not be shared in the same way in another. This~     information may also be shared differently between spouses, siblings, or parents and~     children. It may even be shared with more distant relatives. Knowing the information that~     family members share and how they share it may help researchers improve genetic disease~     treatment and support plans. Family surveys of people who have genetic health risks may help~     provide this information.~      Objectives:~      - To study how family members affected by genetic-related diseases share health information~     with each other.~      Eligibility:~        -  Individuals at least 18 years of age who can read English or Spanish.~        -  Participants affected by a genetic disease or be related or married to someone who has~          the disease.~      Design:~        -  Participants will be screened with an initial questionnaire. They will identify their~          genetic disease and provide a basic health history.~        -  Participants who have the disease will complete an online survey or participate in a~          personal interview. The questions will take about 45 minutes to 1 hour to answer. The~          survey will ask about family health history and family support. Participants will also~          provide referrals to a spouse or relatives who will participate in the study.~        -  The spouse or relative will answer a similar survey. The survey will ask about health~          history and support for the spouse/relative with the disease.~        -  A gift card will be given as thanks for participating in the study.~   "
147713|NCT01633008|"~     Background:~        -  Neurofibromatosis type 1 (NF1) is a genetic disorder that can cause frequent and~          significant pain. This pain can have a severe impact on a person s quality of life.~        -  Acceptance and Commitment Therapy (ACT) is a new type of therapy that may help people~          manage pain. It teaches behavioral techniques that can be used to change how people~          react to pain. ACT may help people with NF1 cope better with the pain associated with~          the disorder. Researchers want to test ACT techniques to see if they can improve coping~          in people with NF1 pain.~      Objectives:~      - To see if ACT can help treat chronic pain in adolescents and young adults who have NF1.~      Eligibility:~      - Adolescents and young adults between 12 and 21 years of age who have chronic pain~     associated with NF1.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          complete a set of questionnaires about their pain levels, quality of life, and~          medications that they are taking.~        -  Participants will take part in a training workshop for ACT. It will consist of three~          2-hour sessions over 2 consecutive days. The workshop will teach techniques for setting~          goals that reflect personal values, and changing the focus from pain avoidance to pain~          management. There will be practice exercises between each session.~        -  At the end of the workshop, participants will receive a workbook with the exercises to~          continue to practice at home. Participants will be encouraged to spend at least 20~          minutes, three times per week, on these practice exercises.~        -  There will be a followup phone call to check on pain management after the workshop.~        -  Three months after the first study visit, participants will complete the study~          questionnaires again from home. They will provide more information about how they are~          managing their pain. The questionnaires will be returned by mail in an envelope provided~          by the study team.~   "
147714|NCT01632995|"~     This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure~     prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine~     (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually transmitted disease (STD)~     clinics and a community health center in the United States.~   "
147715|NCT01632982|"~     This study will develop and evaluate the preliminary efficacy and cost-effectiveness of a~     mobile phone-delivered psychosocial intervention for opioid-dependent adults (N=219) in~     methadone maintenance treatment (MMT). A three-arm, randomized clinical trial will evaluate~     the relative efficacy of: (1) standard MMT; (2) standard MMT plus the mobile intervention;~     and (3) a mobile-based control condition on the primary outcomes of treatment retention and~     opioid use (assessed via urine toxicology). If results are promising, this novel therapeutic~     tool may have a tremendous impact on improving access to and effectiveness of substance abuse~     treatment in a variety of other populations (and could also be adapted for an array of other~     behavioral health applications), while significantly limiting costs.~   "
147716|NCT01632969|"~     The purpose of this study is to improve the quality of care provided for head and neck cancer~     patients. By better understanding the end of life experiences of dying patients and their~     families, the investigators hope to better anticipate and improve upon the experiences of~     future patients and their families.~   "
147717|NCT01632956|"~     There are few breast cancer support groups that focus on the specific needs of Chinese women.~     The purpose of this study is to learn about two different ways of providing support groups to~     help women of Chinese descent cope with the difficulties of a diagnosis of breast cancer and~     its treatment. The investigators want to learn about how best to support Chinese women with~     breast cancer by providing two different types of groups: an in-person support group and a~     virtual (online/phone) support group.~   "
147718|NCT01632943|"~     This study is to evaluate efficacy and safety of renal denervation in the treatment of~     uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45~     subjects. The study will be conducted at up to 8 actively enrolling investigational sites.~     The primary endpoint is change in Office Systolic Blood Pressure from baseline to 6 months~     post-procedure.~   "
147719|NCT01632930|"~     The ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis~     of prostate cancer, the first human cancer and second leading cause of cancer death. Overall,~     in more than half of cases, prostate biopsies performed in search of a prostate cancer are~     negative. In this population, there is no consensus recommendation on how to care, leading to~     repeated invasive biopsies, potential sources of complications.~      The PCA3 urine test (ProgensaTM, GenProbe) is an innovative diagnostic tool to predict the~     positivity of prostate biopsies, especially in patients who had at least one negative biopsy.~     Proposed in clinical practice in France as a commercial kit, it is expensive and is not~     covered by health insurance. It is therefore essential to assess the medical and economic~     impact of its introduction into medical practice.~      The investigators propose to set up a study of high standard of proof, multicenter, based on~     recruitment of patients treated in hospitals. This working hypothesis is that the~     availability of the PCA3 test results would reduce the number of invasive biopsies performed~     incorrectly in patients already had at least one negative biopsy, thus improving the~     diagnostic strategy of prostate cancer.~   "
147720|NCT01632917|"~     The objectives of this trial are to evaluate the safety and tolerability of ATX-101~     injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations.~   "
147721|NCT01632904|"~     The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects~     treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the~     percent of subjects who achieve a clinically meaningful symptom improvement (ie, total~     symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is~     also designed to demonstrate that these responses are durable with continued treatment.~   "
147722|NCT01632891|"~     The purpose of this study is to see if antiretroviral therapy (ART) is safe and works at~     getting rid of malaria in blood and to see whether one type of ART is better than another.~     This study may offer information for further research in looking at whether ART plays a role~     in the prevention and treatment of malaria.~   "
153353|NCT01559064|"~     This is a prospective, observational study of the volumizing effect of aesthetic use of~     Juvéderm VOLUMA® with lidocaine in the mid-face area.~   "
147730|NCT01632787|"~     Patients with acute exacerbation of chronic headache disorder present frequently to the~     Emergency Department (ED) for pain management. A novel etiology of headaches is Vertical~     Heterophoria (VH), a poorly understood and little recognized binocular vision malady that~     when treated with realigning prismatic spectacle lenses results in marked reduction in~     headache and other associated VH symptoms.~      This study aims to determine the accuracy of the Vertical Heterophoria Symptom Questionnaire~     (VHSQ) in identifying a ED headache patients who will experience significant reduction in VH~     symptoms with use of realigning prismatic spectacle lenses. This study's secondary purpose is~     to determine if VH is a common cause of chronic headache disorders in ED headache patients.~      To achieve these goals, a prospective observational study will be performed on ED headache~     patients > 18 years old. All will be given the VHSQ, and all will be assessed for a diagnosis~     of VH by an optometrist who will utilize a novel VH testing method. High and low score groups~     on the VHSQ will then be compared to each other to determine the prevalence of VH in each.~   "
147731|NCT01632774|"~     Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents~     relatively rare, but potentially serious leading to death at scene in most of the cases. The~     study was undertaken to delineate mortality and its risk factors on three different levels~     (pre-hospital, in-hospital and overall). Between 1990 and 2003, all consecutive patients and~     victims with traumatic aortic rupture were retrospectively analyzed by reviewing hospital and~     autopsy records.~   "
147732|NCT01632761|"~     The VITamin D and OmegaA-3 TriaL (VITAL; NCT01169259) is a randomized clinical trial in~     20,000 U.S. men and women studying whether taking daily dietary supplements of vitamin D3~     (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among VITAL participants and will study~     whether vitamin D or fish oil: (A) in the overall VITAL cohort, reduces the number of persons~     diagnosed with anemia and (B) in a subcohort of 900 participants seen in Boston, effects~     long-term changes of the proteins in blood in both anemic and non-anemic individuals who~     provide blood samples at the start of the study and again 2 years later.~   "
147733|NCT01632748|"~     This research is being carried out in order to compare two alternative versions of the~     Neurotech Vital Devices which have been set up to provide two different types of stimulation.~     Both these devices will be fully functioning devices and the investigators want to collect~     information on your perception of the two alternative modes. The patient will be asked to~     provide feedback on both devices which will look identical. The patient will not be told in~     which order the units were given to them until the completion of your visit.~   "
147734|NCT01632735|"~     The primary purpose of this study is to test the effectiveness of a pilot mobile based~     continuing care program (monitoring/feedback texting) relative to standard continuing care as~     usual in reducing relapse and improving psychosocial functioning outcomes in a youth~     population (under 24) with substance abuse problems.~   "
147735|NCT01632722|"~     Early-stage colorectal cancer(CRC)is localized and resectable, but 20% of the patients have~     metastatic disease at the time of diagnosis and 50% of all patients eventually die of the~     disease. The most frequent site of colorectal metastases is the liver, which accounts for 30%~     to 60% of cases. In these patients, the extent of liver disease is the main determinant of~     survival. Hepatectomy is the only potentially curative therapy for colorectal liver~     metastases (CLM), but when traditional criteria for resectability were used, only 10% of~     patients were candidates for surgical resection.~      Although adjuvant systemic therapy after resection of primary colorectal tumors is well~     established, there are relatively few data on the use of postoperative therapy vs. surgery~     alone in patients who have undergone resection of liver metastases. In this trial, the~     absolute increase in the 3-year PFS rate with the addition of FOLFOX4 was a modest but~     significant 9% in patients who had resection (from 33% to 42%; P = .025). For improving~     survival in patients with CLM, several studies with biologic agents have been tried. The use~     of bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), has~     resulted in increased response rates in patients with stage IV colorectal cancer and improved~     OS and PFS. In an ongoing phase II trial presented in ASCO 2008, in patients who were~     potentially curable through resection of liver metastases, perioperative treatment with~     capecitabine and oxaliplatin (XELOX) plus bevacizumab yielded an overall response rate of 73%~     with stable disease in 21% and a mean PFS of 27 months. Response to chemotherapy~     significantly correlated with a prolonged PFS (P < .001).~      On the basis of these backgrounds, we designed a phase II study to compare the effectiveness~     of combination chemotherapy with perioperative or postoperative bevacizumab treatment in~     patients with CLM.~   "
147736|NCT01632709|"~     The purpose of this study is to see how Post Amputation Pain (PAP) affects the body and brain~     by using sensory testing (such as pinprick testing), taking pictures of your brain (using a~     functional magnetic resonance imaging (fMRI) machine) and biomedical interventions (such as~     an injection of pain medicine). All medicines and the fMRI machine used during this study are~     FDA approved. The investigators hope that by learning the causes of PAP, the investigators~     can help future amputees.~   "
147737|NCT01632696|"~     Tumor Imaging of I-124 PGN65 in Solid Tumors~   "
147738|NCT01632683|"~     This study evaluates success rates of tracheal intubation (passing a breathing tube)for~     patients who may be more challenging to intubate while utilizing one of two devices that~     facilitate placement of the tube with video technology.~   "
147739|NCT01632670|"~     The purpose of this study is to determine the effect of music therapy before, during, and~     after cardiac catheterization is associated on (a) change in reactive hyperemia index~     measured before and after catheterization using peripheral arterial tonometry and (b) patient~     stress and discomfort measured by a questionnaire, as compared to the standard of care (no~     music during cardiac catheterization).~      The hypothesis of the study is that music therapy during cardiac catheterization will be~     associated with more favorable change in reactive hyperemia and higher patient satisfaction~     compared to no music playback.~   "
147762|NCT01632371|"~     The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated~     balloon (PCB) is superior to PCB alone for the treatment of restenosis within limus-eluting~     stents (LES)~   "
147763|NCT01632358|"~     The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients~     with dyslipidemia.~   "
147764|NCT01632345|"~     The hypothesis tested in this study is that doravirine (MK-1439) at the final dose selected~     is superior to efavirenz, each given in combination with TRUVADA®, as measured by the~     percentage of participants with CNS events by Week 8. If superiority is established at Week~     8, the same hypothesis will be tested for Week 24.~   "
147765|NCT01632332|"~     The purpose of this study is to look at the safety and immune response to a vaccine used in~     patients previously treated for HER2 (human epidermal growth factor receptor 2) positive~     breast cancer.~   "
147740|NCT01632657|"~     Patients with unruptured brain aneurysms and pain syndromes like trigeminal neuralgias often~     undergo minimally invasive brain surgery with a smaller incision,shorter duration of~     procedure and in some patients the possibility of going home on same day. Postoperative pain,~     nausea and vomiting are sometimes difficult to manage with conventional medications. This~     affects recovery from surgery and often delays discharge from the hospital. This study looks~     at the use of a medication called sumatriptan which is a drug that has been used in the~     treatment of migraine headaches for a very long time. This drug works on the receptors in the~     lining of the brain and around the nerves which maybe associated with pain. The purpose of~     this study is to determine if this pain medication sumatriptan given at the end of the~     surgery improves the postoperative course in terms of less pain, less nausea and vomiting and~     generally having a better postoperative quality of recovery.~      Our main hypothesis is that subcutaneous sumatriptan (6mg) administered at the end of surgery~     will improve the postoperative quality of recovery at 24 hours after elective minimally~     invasive craniotomies.~   "
147741|NCT01632644|"~     The primary objective of this study is to investigate the patient experience during skin~     biopsy.~   "
147742|NCT01632631|"~     Ongoing technological advances, especially in the field of image processing, have refined~     medical simulations to offer life-like replications of medical and surgical procedures in a~     variety of specialties. Patient-specific image data are incorporated into these simulations,~     and transformed into a 3D model. This enables the practitioner and his/her team to perform~     and practice 'real' cases on a virtual patient prior to performing the real procedure on the~     actual patient. This new technology has been referred to as 'patient-specific' rehearsal,~     also 'mission' or 'procedure' rehearsal.~      Research has already proven that simulated patient-specific rehearsal of a carotid artery~     stenting procedure may enhance surgical and team performance.~      The PROcedure rehearsal software can now also be used to practice patient-specific~     endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a~     challenging and complex procedure like EVAR may not only influence device selection based on~     preoperative planning, but also improve the technical performance of the surgeon/radiologist~     and the awareness and communication within the entire endovascular team. However, further~     research is needed to evaluate if this new technology may enhance clinical safety and~     efficiency, i.e. if patients actually benefit from physicians and team members conducting~     patient-specific rehearsals of EVAR interventions.~   "
147743|NCT01632618|"~     Low back pain (LBP) is the most frequently reported musculoskeletal problem and third most~     frequently reported symptom of any kind in people over the age of 75. In fact, 17.3% of all~     visits to physicians for LBP involve individuals over 65. In older adults, LBP has been~     associated with a host of negative consequences, including decreased physical function,~     increased fall risk, increased mood disturbance and increased health care utilization.~     Surprisingly, little research has focused on LBP in people over 65. But, recent evidence~     demonstrates that LBP is associated with increased intramuscular fat infiltration in the~     abdominal and paraspinal muscles and that this altered muscle composition increases the risk~     of mobility-related functional decline in older adults. While trunk muscle training (TMT) has~     been used in younger LBP groups, it is unproven in elders and, alone may not be sufficient to~     substantially improve function and symptoms, given the compromised state of ages muscle. TMT~     augmented with neuromuscular electrical stimulation (NMES) known to improve strength and~     function beyond the capacity of volitional exercise alone, may provide greater improvements.~     Treatment of chronic LBP in older adults using an exercise intervention has been hypothesized~     as a way to prevent functional decline and frailty progression; however this hypothesis has~     yet to be experimentally confirmed. In this exploratory study, the investigators will test~     the hypothesis that TMT plus NMES will result in reduced disability and pain severity~     compared to usual care in elders with chronic LBP.~   "
147744|NCT01632605|"~     The purpose of this study is to evaluate the safety of a daily single oral dose of sirolimus~     in patients with advanced autosomal dominant polycystic kidney disease.~   "
147745|NCT01632592|"~     Obesity is strongly associated with risk of cardiovascular disease (CVD). Data increasingly~     suggest that visceral adipose tissue (VAT) accumulation -- or increased abdominal fat -- is~     particularly deleterious to cardiovascular health, but further study is needed to test this~     idea. Increased abdominal fat may also be associated with lower secretion of a hormone called~     growth hormone (GH), which helps the body burn fat. The current study aims to carefully~     characterize relationships between abdominal fat and CVD. In addition, by using a medication~     called growth hormone releasing hormone, which is a strategy to reduce abdominal fat, the~     investigators will test the hypothesis that abdominal fat contributes uniquely to increased~     arterial inflammation.~      In the first part of this study, the investigators will investigate both lean (healthy~     weight) individuals and individuals with increased abdominal fat. The investigators will~     study their body composition, cardiovascular risk measures, insulin sensitivity, and growth~     hormone dynamics, with the hypothesis that abdominal fat, independent of general obesity,~     will be strongly associated with arterial wall thickening and atherosclerotic inflammation.~     The investigators will assess arterial wall thickness, plaque morphology, and atherosclerotic~     inflammation, and the investigators will determine associations between these variables and~     regional fat accumulation, with particular attention to abdominal fat.~      The second, treatment part of the study will be only for individuals with increased abdominal~     fat who are found to have low growth hormone secretion. In that part of the study, the~     investigators will test the effects of a growth hormone releasing hormone (GHRH) analogue to~     reduce abdominal fat and, consequently, reduce arterial inflammation. The investigators~     hypothesize that abdominal fat reduction, independent of changes in growth hormone, will~     reduce arterial inflammation and arterial wall thickness.~   "
147746|NCT01632579|"~     This is a phase I study of LY3023703 in healthy participants. The purposes of this study are~     to look at safety, how well the study drug is tolerated, how much of the study drug gets into~     the blood stream, and how long it takes the body to get rid of it when given to humans.~     Information about any side effects that may occur will also be collected. Participants will~     remain in the study for approximately 3 months. This study is for research purposes only and~     is not intended to treat any medical condition.~   "
147747|NCT01632566|"~     The purposes of this study are to look at safety, how well the study drug is tolerated, how~     much of the study drug gets into the blood stream, and how long it takes the body to get rid~     of it when given to healthy Japanese and non-Japanese participants as multiple doses. In~     addition, effects of 28-day oral dosing of LY3131207 on the amount of a cholesterol-lowering~     drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of~     it will be determined. The effects of LY3131207 after single and 28-day dosing on blood~     pressure will also be studied. Information about any side effects that may occur will be~     collected.~   "
147766|NCT01632319|"~     The purpose of this study is to investigate the effectiveness of 2 different therapy courses~     for undergraduate college students who binge drink and experience depressive symptoms.~   "
147767|NCT01632306|"~     Purpose of this phase I/II study is to test how well LY2090314 works in combination with~     different chemotherapies in treating participants with metastatic pancreatic cancer.~   "
147748|NCT01632553|"~     This study looks at the biological effect of domestic violence and abuse (DVA) on women's~     mental health. The mechanisms through which DVA causes mental disorders are very poorly~     understood. Similar to other demands, DVA activates the biological stress system, of which~     the chief component is the hypothalamic-pituitary-adrenal (HPA) axis, which produces chemical~     cortisol. Cortisol levels increase in response to short-term demand and help organisms deal~     with it by changing the processes of getting energy from food and also mental function.~     However constant activation of the HPA axis can cause damage and accelerate disease.~      This study tests the hypothesis that compared to non-abused women all abuse victims have~     altered diurnal rhythm in cortisol secretion and that the pattern of this alteration is~     predicted by abuse characteristics, such as its type, severity, duration, and cessation. To~     examine the hypothesis the following research questions will be addressed: 1) whether~     cortisol levels are related to mental health state; 2) whether cortisol levels are related to~     type, severity, duration and cessation of DVA; 3) whether there is any difference in cortisol~     concentrations between those women exposed to both childhood abuse and DVA and those who have~     experienced only the latter; 4) whether cortisol levels vary between women, living in refuge~     and those not living in refuge?~      To answer these research questions 214 women will be recruited in a domestic violence agency.~     Baseline and 3-monthly follow-up measures will be taken over 6 months after recruitment.~     Women will be asked to fill in a questionnaire to evaluate their demographics, health,~     experience of childhood abuse and DVA. Women's weight and height will be taken. In addition~     participants will be asked to take three saliva samples: 1st in the evening in bed, 2nd -~     next morning immediately upon awakening, and the 3rd - in thirty minutes after awakening.~     Saliva will be collected by chewing (for 2 minutes) the cotton pledget provided with plastic~     tube and returned by post or via collection by the researcher. Then the saliva samples will~     be tested for cortisol and cortisone.~      Results of the study will increase our understanding of the biological mechanisms of DVA~     impact on a woman's health and tell researchers and practitioners about the possibility of~     using cortisol as an indicator to diagnose abuse-related health problems and assess~     effectiveness of medical care for abuse survivors.~   "
147749|NCT01632540|"~     This study will be a prospective observational study of real world BDP nasal aerosol users~     with PAR, with or without seasonal allergic rhinitis (SAR). Subjects will respond to monthly~     online surveys regarding rhinitis control, concomitant medical conditions, concomitant~     (non-AR) medications, current AR therapy, and adverse events.~   "
147750|NCT01632527|"~     The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of~     unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy~     secondary to age-related macular degeneration.~   "
147751|NCT01632514|"~     Hypocalcemia is a frequent adverse event after thyroidectomy. It is usually related to~     hypoparathyroidism, but preoperative hypocalcemia, hypomagnesemia or vitamin D deficiency~     contributes to it. This study aims to determine the frequency of vitamin D deficiency or~     insufficiency in patients submitted to thyroidectomy, to define the risk attributed to~     vitamin D deficiency to postoperative hypocalcemia, to identify other factors associated to~     postoperative calcium disorder, and to evaluate the benefit of preoperative treatment of~     vitamin D deficiency to prevent postoperative hypocalcemia.~   "
147752|NCT01632501|"~     The freedom of choice in medicine is based on the physician's ability to treat their patients~     with the best available therapy. The armamentarium for percutaneous intervention is~     frequently determined on the basis of subjective criteria and the experience of the~     interventional cardiologist. The evaluation of devices used in coronary intervention,~     especially angiography and its clinical outcomes, has rarely been investigated; the~     exceptions are studies on stents. Therefore, the freedom of choice for the interventional~     cardiologist has been challenged, especially because of cost restrictions. This way this~     study aims to assess the safety and efficacy of a device of a single brand in performing~     percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and~     stents) in selected patients.~   "
147753|NCT01632488|"~     The study aims to:~        1. Determine whether the density of epithelial gaps in terminal ileum of patients with~          irritable bowel syndrome (IBS) is different from that in inflammatory bowel disease~          (IBD) patients and normal controls by confocal laser endomicroscopy (CLE).~        2. Evaluate the relationship between the density of epithelial gaps and IBS subtypes, and~          visceral hypersensitivity.~   "
147754|NCT01632475|"~     This is a long term follow-up study of the open label, single-center, phase I clinical trial~     to evaluate the safety of Pneumostem® in premature infants with BPD.~   "
147755|NCT01632462|"~     Background VSL#3 has been reported as an effective adjuvant therapy both in inducing and~     maintaining remission in pediatric patients affected by Ulcerative Colitis. In addition, it~     has been shown that VSL#3 is able to modulates barrier function, intestinal permeability, and~     innate host functions, which if altered, could have a profound impact on the state of~     colitis. However it is still unclear how VSL#3-induced changes in microbial composition~     affect the status of intestinal inflammation and no study have investigated the efficacy of~     VSL#3 in the maintenance of remission in pediatric patients with Crohn's disease (CD).~      Objectives The purpose of this study will be to evaluate the effect of a probiotic~     formulation, VSL#3, versus placebo, on metabolic profile, intestinal permeability,~     microbiota, cytokines and chemokines expression in pediatric patients with CD in remission of~     disease. In addition, the efficacy of VSL#3 on the maintenance of remission will be assessed~     and the safety and the tolerability of the probiotic formula will be evaluated.~      Methods This investigation will be a prospective, multicenter, randomized, double-blind,~     placebo-controlled, cross-over trial. The study will include 50 children affected by CD in~     remission of disease, as defined by a PCDAI < 10, under treatment with Azathioprine~     associated or not to 5-ASA and will be articulated in 6 months as follows. All children will~     be randomised to a treatment group receiving for 2 months either 1-2 packet containing 900~     billion bacteria/day of VSL#3 according to their weight, and a group receiving the placebo~     drug. Assignment to therapy or placebo will be determined according to a computer-generated~     randomization scheme. At the completion of the 8 weeks, a wash-out period of 6 weeks will~     be done, when no preparation will be administered. Then each patient will be switched to the~     other group and followed likewise for further 8 weeks. All patients will continue regular~     medications throughout the study period. A group of 10 volunteer healthy children, comparable~     in age and sex, will be used as reference group for the analysis of metabolic profile.~     Patients will be assessed clinically at baseline and every 8 weeks until the completion of~     the study, at 24 weeks or at the time of relapse. At every visit data will be collected~     including patient questionnaires regarding disease activity (stool frequency, stool~     consistency, hematochezia, abdominal pain, extraintestinal manifestations of disease, and~     overall patient functioning). Additional information collected at the first visit included~     demographic data, family history, and symptom onset. Physical examination will be performed~     at each visit by a paediatrician and included an abdominal examination and examination for~     extraintestinal manifestations of CD. Routine blood tests for CD, cellobiose/mannitol small~     intestinal permeability study, stool cultures, stool calprotectin, will be performed at every~     visit and/or at the time of relapse. Urine will be collected for the analysis of metabolic~     profile with mono and bi-dimensional high-resolution 1H NMR spectroscopy. PCDAI and a~     physician's global assessment will be used to measure disease activity. At baseline and at 24~     weeks the patients will undergo ileocolonoscopy to evaluate and endoscopic and histological~     activity of disease. Evaluation of microbiota on biopsies and stool samples will be performed~     at the time of ileocolonoscopies using Fluorescence In Situ Hybridization. Colon biopsies~     cultures will be performed in order to evaluate cytokines and chemokines patterns by~     multiplex assay. Additional data will be collected during the study regarding the safety and~     tolerability of therapy with VSL #3. Statistical analysis will be performed using SPSS~     version 15 (SPSS Inc, Chicago, Illinois, USA). Variables will be screened for their~     distribution and appropriate parametric or non parametric tests will be adopted as required.~     Cross-tabulations will be evaluated by using the Fisher test and χ2test. Statistical~     significance will be predetermined as P < 0.05.~      Expected results The investigators expect to find profound alterations in metabolic profiles,~     intestinal permeability, microbiota, cytokines and chemokine patterns of patients affected by~     CD. The administration of VSL#3 is expected to ameliorate all these alterations eventually~     identified. From a clinical point of view the effects of VSL#3 could be translated in~     prolonged clinical remission maintenance, offering a new therapeutic tool in the treatment of~     CD.~   "
147756|NCT01632449|"~     This is an single-blind, single-center, two-period crossover, PK profile study. Each subject~     will be randomized to one of two treatment sequences. Both treatment sequences will be~     enrolled concurrently.~   "
147757|NCT01632436|"~     This study will be conducted in patients with metastatic cancer and either moderate, severe,~     or no hepatic impairment who have failed other antineoplastic therapies or for whom there is~     no standard therapy. The study will be conducted in two stages. Using an existing pixantrone~     population pharmacokinetic (PPK) model, a model-based strategy will be used to evaluate the~     findings from the first stage of the study conducted in patients with moderate hepatic~     impairment and matched controls. The PPK evaluation will be completed prior to enrolling~     patients with severe hepatic impairment and additional matched controls during the second~     stage of the study. Patients with hepatic impairment will be paired with matched control~     patients with normal hepatic function, matched on gender, age, and body surface area (BSA).~   "
147758|NCT01632423|"~     This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice~     for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).~   "
147759|NCT01632410|"~     The study describes the autonomic control system function in subjects post stroke in~     comparison with healthy subjects.~      Aims: To describe the Autonomic hart rate control system function in post stroke subjects in~     different rehabilitation levels in comparison with healthy subjects.~      To examine the reflective reaction of the autonomic control system as reflected in the heart~     rate variability to stimulations subjects in different rehabilitation levels in comparison~     with healthy subjects.~      To examine the autonomic control system reaction as reflected in the heart rate variability~     to physical and cognitive action subjects in different rehabilitation levels in comparison~     with healthy subjects.~   "
147760|NCT01632397|"~     Following formative work, the proposed study is an open-label, pilot, randomized, two arm~     trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a~     cognitive-behavioral based adherence intervention or health education with supportive~     counseling.~   "
147761|NCT01632384|"~     The purpose of this study is to see how the brain differs between smoking regularly and after~     not smoking for 24 hours. The investigators will be using an MRI machine to get the~     information from adult smokers and non-smokers while they lie in the scanner with their eyes~     closed. Smokers will be scanned when they have not smoked for 24 hrs and shortly after~     smoking. It is our hypothesis that brain activity will be altered after not smoking for 24~     hours.~   "
147769|NCT01632280|"~     In this project the investigators aim to improve eating control and weight loss outcomes in~     patients undergoing LAGB with an innovative brain-based intervention. Specifically, the~     investigators will enhance the activity of the right inferior frontal gyrus, a core region of~     the brain circuit of inhibitory control, using transcranial direct current stimulation~     (tDCS).~   "
147770|NCT01632267|"~     Antidepressants are among the most widely prescribed medications, yet only 35-45% of patients~     achieve remission following an initial antidepressant trial. The financial burden of~     treatment failures in direct treatment costs, disability, decreased productivity, and missed~     work may in part derive from a mismatch between optimal, and actual, medications prescribed.~     The present one year retrospective study seeks to evaluate the indirect and direct healthcare~     costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in relation to an~     interpretive reporting system designed to predict antidepressant responses based on DNA~     variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin transporter gene~     (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.~   "
147771|NCT01632254|"~     The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify~     the plaque composition and lipid content of plaques and will have the potential for repeated~     in vivo measurements. To investigate sensitivity and specificity of 3.0 Tesla MRI and MRS for~     dimension and composition assessment of carotid artery plaques, in particularly those plaques~     with lipid rich necrotic cores. This non-invasive cross-sectional study, compares carotid~     parameters of in-vivo 3.0 Tesla MRI, MRS and B-mode ultrasound with histology specimens~     collected at endarterectomy.~   "
147772|NCT01632241|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab~     in adult patients of black race with systemic lupus erythematosus (SLE; lupus).~   "
147773|NCT01632228|"~     This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate~     the safety and efficacy of onartuzumab in combination with bevacizumab as compared to~     bevacizumab alone in participants with recurrent glioblastoma. Participants will be~     randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus~     bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity,~     participants or physician decision to discontinue, or death.~   "
147774|NCT01632215|"~     The purpose of this study was to evaluate the postoperative analgesic effect of preoperative~     gabapentine for carpal tunnel syndrome surgery.~   "
147775|NCT01632202|"~     Seprafilm is an FDA-approved temporary bioresorbable barrier that physically separates~     opposing tissue surfaces. The physical presence of the membrane separates adhesiogenic tissue~     while the normal tissue repair process takes place. When used in the abdominopelvic cavity,~     it has been shown to reduce the incidence of adhesions.~      The intrauterine cavity is a potential space where the walls of the uterus are collapsed upon~     itself in the normal state. It has been demonstrated that the trauma of removing a submucosal~     fibroid with electrocautery exposes the uterus to great potential for intrauterine adhesions~     since the raw charred surface is directly opposed to the opposite endometrial surface.~     Previous studies have shown that the placement of hyaluronic acid in the intrauterine cavity~     after a myomectomy is not only safe, but also decreases the incidence of intrauterine~     adhesions.~      The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine~     cavity and creating a temporary physical barrier between the walls of the uterus, that they~     will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48~     hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one~     week, the investigators anticipate that the patient will have minimal to no discomfort; since~     no physical device is being left in the endometrial cavity, the uterus will not be~     contracting more than it does in its normal postoperative state.~   "
147776|NCT01632189|"~     This study will evaluate effects of treatment with varenicline, a smoking cessation drug, on~     the dopaminergic system by using Positron Emission Tomography (PET) imaging with new~     radioligand, [11C]-(+)-PHNO. The investigators primary hypothesis is that chronic varenicline~     administration will increase dopamine (DA) receptors levels ([11C](+)PHNO) within the human~     brain.~   "
147777|NCT01632176|"~     This randomized controlled trial (RCT) study is a small scale test of the feasibility and~     preliminary efficacy of a brief motivational interview-style intervention. The intervention~     took place in the pediatric emergency departments by a trained interventionist and will~     followed an intervention algorithm developed by a team of dating abuse and brief intervention~     experts. The research design is as follows: the investigators will randomize youth ages 12-19~     years old to one of two groups: one group who receives the intervention (N=~18), and the~     other which does not (N=~18). The investigators compared changes in outcomes from baseline to~     1-month follow-up for those in both groups. The investigators looked at outcomes including~     dating abuse-related knowledge, attitudes about the use of violence to resolve conflict, and~     dating abuse behavior (perpetration and/or victimization).~      Statement of study hypothesis: Youth who receive the intervention will show improvements in~     dating abuse-related knowledge, attitudes and behavior that are maintained for 1 month, while~     those in the comparison group will show no similar change.~   "
147778|NCT01632163|"~     Primary Objective:~      - To assess the effects on glycemic control of lixisenatide in comparison to placebo as an~     add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over~     a period of 24 weeks in insufficiently controlled type 2 diabetic patients.~      Secondary Objectives:~        -  To assess the effects of lixisenatide over 24 weeks on :~             -  percentage of patients reaching HbA1c<7% or ≤6.5%,~             -  2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during~               standardized meal challenge test,~             -  fasting plasma glucose (FPG),~             -  change in 7-point self-monitored plasma glucose (SMPG) profile),~             -  body weight,~             -  change in daily basal insulin dose.~        -  To assess lixisenatide safety and tolerability.~        -  To assess anti-lixisenatide antibody development.~   "
147779|NCT01632150|"~     The purpose of this study is to determine the safety and tolerability of elotuzumab~     administered in combination with thalidomide and dexamethasone in the treatment of relapsed~     and/or refractory multiple myeloma.~   "
147780|NCT01632137|"~     The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic~     suspension in subjects with dry eye syndrome.~   "
147782|NCT01632111|"~     The objective of this study is to investigate whether Agalsidase alpha, a drug commonly~     prescribed in patients with Fabry disease, is associated with improvement of the pulmonary~     involvement. According to the Global Initiative for Obstructive Lung Disease (GOLD), the~     surrogate markers for obstructive lung diseases are a decrease in both forced expiratory~     volume in one second (FEV1) and FEV1/FVC ratio, whereas FVC is the forced vital capacity.~     However, the measurement of these lung function parameters is indicated as yearly follow-up~     examinations with or without the treatment of Agalsidase alpha in patients with Fabry~     disease.~   "
147783|NCT01632098|"~     Obesity is one of the biggest public health challenges today and in the years to come,~     particularly due to its rising prevalence in children and adolescents. In addition to the~     increased health risks for each individual, obesity causes a tremendous economic burden on~     the healthcare system.~      Here, the investigators will examine the impact of extreme obesity on healthcare utilization,~     costs, and health related quality of life in adolescents. The study is a subproject of the~     Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects~     of structured care study, short: Youth with Extreme obesity Study (YES), which aims at~     improving the medical care and social support structures for youth with obesity and extreme~     obesity in Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and~     24.9 years (initially up to 21 years) are eligible to participate. Participants will complete~     questionnaires to assess health related quality of life and utilization of healthcare. These~     questionnaires will be applied at baseline and then every 12 months (initially every 6~     months) during health check-ups. As part of the other subprojects of YES, participants will~     be invited to complete further questionnaires and will be offered a thorough medical~     examination, medical care and psycho-social support.~      The investigators expect to provide valid and up-to-date information on costs and~     health-related quality of life for obese adolescents. This information will help in the~     planning of useful and cost effective preventive and therapeutic strategies, and improve the~     medical care and support structures for obese adolescents.~   "
147784|NCT01632085|"~     Reduce the risk of nosocomial transmission of germs related to the reusability of the~     laryngoscope handle. The alternative is to replace it with a disposable device, provided that~     it is as effective as the reference strategy at a reasonable cost.~   "
147785|NCT01632072|"~     The purpose of this study is to determine whether a nutrition intervention during a~     rehabilitation stay followed by nutritional advice after discharge, can improve the~     nutritional status of the patients after 3 months.~   "
147786|NCT01632059|"~     Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine~     Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as~     prognostic value.~      This study looks into ADMA as a good prognostic factor for sepsis. Further more the~     dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.~   "
147787|NCT01632046|"~     Peritoneal Dialysis (PD) is the preferred treatment modality in children with end-stage renal~     disease. Unfortunately progressive alterations of the peritoneal membrane occur with time on~     PD, leading to a continuous loss of peritoneal transport function. Recently, double-chambered~     PD solutions with less Glucose Degradation Products (GDPs) and neutral pH have been approved~     for the European market. Short term administration suggests comparable clearance rates~     compared with conventional solutions. In vitro studies demonstrate an improved local immune~     defense system. To compensate for metabolic acidosis, the available solutions either contain~     lactate or bicarbonate, the impact of either buffer on long term acidosis control and~     peritoneal membrane integrity, however, is unknown.~      The prospective, European multi-center study will provide the first long term administration~     of pH neutral, low GDP solutions in children. 60 children will randomly be treated with a~     bicarbonate (BicaVera) and a lactate based solution (Balance), respectively. The primary end~     point will be the effect of either PD-solution on peritoneal transport characteristics (D/P~     Creatinine). Secondary end-points will be the effects on ultrafiltration capacity, acid-base~     balance, peritoneal morphology, incidence and severity of peritonitis, and on surrogate~     parameters of biocompatibility and carbonyl stress. Moreover, potential genetic determinants~     of the peritoneal transporter status and of the continued morphological transformation of the~     peritoneum will be assessed.~      After a 2 month run-in period, using a conventional, acidic, single-chambered PD-solution,~     the patients will be randomized to a 10 month study period using BicaVera and Balance,~     respectively. Dialysis regime and follow up in the out-patient clinic will be performed~     according to clinical needs (every 4 weeks); episodes of peritonitis will be treated~     according to international guidelines. Bicarbonate supplements will be prescribed at a dose~     of 0.5 mmol/kg *d, if blood bicarbonate levels fall below 17 mmol/l. PD adequacy will be~     verified by routine, monthly venous blood sampling and a capillary blood gas analysis. 2-5 ml~     of blood will be drawn for analysis of relevant gene polymorphisms. At study entry, after 3,~     6 and 10 months, a 24h dialysate- and urine collection, a peritoneal equilibration test an~     intraperitoneal pressure measurement will be performed. Peritoneal biopsies will be obtained~     at any time of abdominal surgery. Adverse events will be screened meticulously. The trial~     will be carried out in accordance with the German medicines act (AMG) and other local~     requirements, with particular reference to the ICH guidelines for Good Clinical Practice, and~     the declaration of Helsinki. At study end, the patients will decide together with the~     responsible physician which PD-fluid should be used further one.~   "
147788|NCT01632033|"~     The purpose of this study is to test the routine faisibility of a questionnaire to estimate~     walking impairment(The WELCH questionnaire) in patients investigated for suspected PAD.~   "
147789|NCT01632020|"~     The purpose of this study is to investigate the effects of short term oral Metformin therapy~     on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal~     adenocarcinoma.~      It is hypothesized that there are independent actions of Metformin on the outcome of subjects~     with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC cell growth~     will correlate with this drug's effects on markers mentioned above, because the markers are~     closely related to tumor growth and metastases.~   "
147790|NCT01632007|"~     The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in~     diabetic patients.~   "
147791|NCT01631994|"~     Summary:~      This study investigates the use of oral dissolving metoclopramide during standard video~     capsule endoscopy. Metoclopramide is a pro -motility agent, that is, this medication helps~     with movement through the stomach and small bowel. This study will help us determine the~     effectiveness of oral dissolving metoclopramide on transit time through the stomach and small~     bowel of the video capsule that is ingested. This study may help with better diagnoses of~     pathology in the small bowel. Each patient enrolled in the study will either be assigned to a~     group that only ingests the capsule or the group that receives the oral dissolving~     metoclopramide plus capsule. Each patient will undergo the same standard procedures and~     precaution used during standard video capsule endoscopy. The patients that will qualify for~     the study are patients that are in need of video capsule endoscopy for further imaging of the~     small bowel. The patients must meet the inclusion criteria provided in the protocol and must~     not meet any of the exclusion criteria in the protocol. The hypothesis is that the patients~     that ingest the metoclopramide will have better capsule images and transit time and will~     allow for enhanced diagnosis of small bowel pathology.~   "
147792|NCT01631981|"~     This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo~     controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics~     of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration~     for the treatment of pain symptoms suggestive of endometriosis. The target population will be~     women of reproductive age with symptoms suggestive of endometriosis.~   "
147793|NCT01631968|"~     Prospective randomized study in cemented primary total knee arthroplasty. In one group the~     cement used was standard cement, without any antibiotics and in the other group the cement~     used was loaded with 0.5 g of erythromycin and 3 million units of colistin in 40 g of cement.~     In all cases intravenous antibiotics prophylaxis against infection was used. In both groups~     the cement was mechanically mixed in a vacuum. One deep drain tube was placed for 24 hours in~     all cases. The main variable was the presence of infection according to the Center of Disease~     Control criteria with a minimum of 12 months follow-up.~   "
147874|NCT01630902|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan~     Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were~     separated by a washout period of 21 days during fasting study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
160915|NCT01459757|"~     Retrospective correlation of clinical outcomes data with mutational status in GIST subjects~     treated with sunitinib.~   "
147794|NCT01631955|"~     Although Cystitis includes a clinical syndrome characterized by various combinations of~     dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or~     abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI~     (referred to as cystitis) has been focused microorganisms and drug-resistance. There has been~     little research on Clinical aspects on cystitis treatment such as bothersomeness, or the~     impact of symptoms on patients' quality of life (QoL). The investigators want to study for~     Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment(Ciprobay)~     in Acute Uncomplicated Cystitis in Korean Women.~   "
147795|NCT01631942|"~     This trial is conducted in Europe. The aim of this trial is to investigate safety,~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to~     healthy male subjects and subjects with haemophilia.~   "
147796|NCT01631929|"~     This is a randomized controlled trial comparing the time needed to get the conditions to~     space hourly controls to controls every 4 hours, using the one bag system versus the two bags~     system, in the initial treatment of children with diabetic ketoacidosis. After fast infusion~     of isotonic saline solution (20 ml/kg) to prevent shock, the administration of maintenance~     fluids and insulin therapy is indicated. Hourly plasmatic levels of glucose controls could~     determine changes in glucose IV administration. On using the classic one bag system each~     change determine a bag change. Using the two bag system allows to deliver the patient the~     appropriate glucose infusion in less time.~   "
147797|NCT01631916|"~     The purpose of this study is to determine the efficacy of addition of corticosteroid therapy~     to antibiotics in children hospitalized with community-acquired pneumonia.~      The hypothesis is that the use of corticosteroids decreases the length of stay in children~     hospitalized with community-acquired pneumonia.~   "
147798|NCT01631903|"~     The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four~     doses of vaginally administered Proellex in premenopausal women with uterine fibroids~     confirmed by ultrasound.~   "
147799|NCT01631890|"~     Consecutive patients who meet the eligibility criteria will be enrolled into the study. All~     patients with gastric varices with no history of gastric variceal bleed (Group C) will~     undergo Endoscopic ultrasound and Upper Gastrointestinal Endoscopy at baseline, at the end of~     first year and at the end of study.~      The patients who presented to Institute of Liver and Biliary Sciences with gastric variceal~     bleed or develop Gastric Variceal bleed during hospital stay will be randomized into Group -A~     (conventional Upper Gastrointestinal Endoscopy + Glue) and Group-B (Endoscopic Ultrasound~     followed by Upper Gastrointestinal Endoscopy+Glue) therapy for gastric varices. Total 90~     patients will be enrolled and randomized into group A and Group B after resuscitation and~     urgent Upper Gastrointestinal Endoscopy with standard therapy for bleeding gastric varices to~     achieve hemostasis.~   "
147800|NCT01631877|"~     After successful screening the cases of cirrhosis of liver irrespective of the etiology who~     have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will~     be recorded and the patient will be randomized into either interventional (acenocoumarol) or~     placebo group along with first five days of subcutaneous Low Molecular Weight Heparin inj.~     Enoxaparin in the interventional arm and placebo injection in the control arm. Every 3~     monthly the Doppler screening for recanalization of portal vein thrombus will be done with~     monitoring of International Normalized Ratio (INR)with target INR 2-3. Both the groups will~     receive the therapy for one year irrespective of the Doppler findings in relation to portal~     vein thrombus re-canalization.Then one year drug free monitoring will be done in both the~     groups as per the primary or secondary outcome. .~   "
147801|NCT01631864|"~     This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and~     oxidative metabolism in obese hypertensive subjects.~   "
147802|NCT01631851|"~     In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder~     (ASD) often exhibit disruptive behavior problems including irritability, tantrums,~     noncompliance, and aggression. This is a pilot study of Cognitive-Behavioral Therapy, also~     known as Anger Control Training, in adolescents with high-functioning ASD. CBT teaches~     children to recognize antecedents and consequences of problem behavior and to use emotion~     regulation and problem-solving skills to reduce irritability, aggression and noncompliance.~     This form of CBT has been well-studied in typically developing children with disruptive~     behavior and we are investigating if this treatment can be feasible and helpful, with~     appropriate modifications, for irritability and disruptive behavior in ASD.~   "
147803|NCT01631838|"~     The objective of this study is to address the anti-thrombotic effects of tocotrienols~     supplementation via modulation of platelet activation, thrombotic markers, inflammatory~     markers and endothelial function.~      It is hypothesized that 2 weeks supplementation of tocotrienols will be able to suppress~     platelet aggregation in subjects with metabolic syndrome.~   "
147804|NCT01631825|"~     -  To investigate the safety of once-daily repeated transdermal administration of SPM 962~          within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's~          disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label~          uncontrolled study.~        -  To investigate efficacy of SPM 962 in an exploratory manner.~   "
147805|NCT01631812|"~     The primary objective of this study is to investigate safety of SPM 962 in advanced PD~     patients in a multi-center, open-label, non-controlled study following once-daily multiple~     transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54~     weeks). Efficacy is also to be exploratory investigated.~   "
147806|NCT01631799|"~     Total knee replacement is very common in Germany. After surgery patients have severe pain in~     the knee; initiation of the physiotherapy, however, is important in the first three days~     after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are~     commonly used after surgery. Both methods are used in Germany. Both methods have advantages~     and disadvantages. We wanted to answer the question which method of analgesia - after total~     knee replacement - is better concerning complications and function (after 3 months) ?~   "
147875|NCT01630889|"~     The purpose of this open-label extension study is to evaluate long-term efficacy and safety~     of FG-4592 in maintaining hemoglobin in dialysis and non-dialysis CKD patients who have~     completed the Treatment Period of an FG-4592 FibroGen-sponsored anemia study.~   "
147807|NCT01631786|"~     Ultrasonography is currently the most common diagnostic tool for imaging the female~     reproductive tissues. However, clinical ultrasonography is limited to the detection of~     ovarian structures ≥ 2 mm, with an inability to image microanatomy including small antral~     follicles and oocytes. The objective of this study is to determine whether the synchrotron~     can be used to effectively image bovine and human ovaries ex situ. We hypothesize that~     synchrotron imaging will provide greater resolution and thereby allow the detection of fine~     structural details of the ovary compared to conventional ultrasonography. Ovaries will be~     imaged using conventional ultrasonography, synchrotron and histology. We anticipate that our~     results will provide important information about ovarian physiology which can be applied to~     the study of female reproductive dysfunctions.~   "
147808|NCT01631773|"~     We hypothesize that the miRNA expression in subjects with nasal polyps and~     Aspirin-exacerbated respiratory disease (AERD) differs from the miRNA expressed in subjects~     with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD).~   "
147809|NCT01631760|"~     We hypothesize that there is a statistically significant difference in miRNA profiling and~     expression of subjects with asthma upon its exacerbation compared to patient's baseline level~     or following effective treatment of an exacerbation of asthma. Therefore, plasma miRNA~     profiling may provide noninvasive, highly specific and sensitive biomarkers for asthma~     exacerbation's detection and treatment follow-up.~   "
147810|NCT01631747|"~     The prevalence of maternal overweight and obesity has nearly doubled in the United States~     since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus 23%~     in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially within~     certain racial, ethnic, and lower socioeconomic groups leading to increased adverse maternal~     and birth outcomes. This study will recruit, randomize and test in 300 ethnically diverse~     OW/OB pregnant women a behavioral intervention aimed at controlling gestational weight gain~     (GWG) through recommended diet, activity and lifestyle changes that are to be maintained~     postpartum. Outcomes include anthropometric (height, weight, percent body fat) metabolic~     (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein) and~     behavioral measures (diet. physical activity, sleep and stress). In addition, babies will be~     measured for length, weight and percent body fat. The goal is to limit excessive gestational~     weight gain through improved maternal lifestyle that can be maintained and modelled for the~     family post partum and beyond.~   "
147811|NCT01631721|"~     The purpose of this study is to understand the factors that lead to adolescent sexual risk~     behavior by investigating both the family contexts and romantic relationships that influence~     adolescent couples' decision-making.~   "
147812|NCT01631708|"~     Haemochromatosis is a preventable genetic iron overload disorder. Untreated, it can shorten~     life due mainly to liver cirrhosis and cancer. It can be prevented by blood donation to~     maintain normal iron levels. It is unclear, however, whether treatment is necessary when~     individuals have moderate elevation of iron in the body. This research project will study the~     effects of treatment in this group by assessing a number of scans, questionnaires and blood~     tests in treated and untreated individuals.~   "
147813|NCT01631695|"~     In this study, the performances of Medasense's non-invasive pain monitoring is compared with~     standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with~     a subjective pain level assessment. The subjective pain level is assessed by the~     anesthesiologist when the patient is under general anesthesia and by the patient and a nurse~     in post anesthetic care unit (PACU).~      The study is based on recording and analyzing the subject's physiological signals, while~     recording painful events, medication dosing and different clinical signs.~   "
147814|NCT01631682|"~     The aim of this project is to create fear conditioning paradigm within which the relative~     strengths of various novel pharmacological and behavioral interventions can be tested. These~     interventions are intended to reduce the fearfulness associated with fear conditioning by~     blocking a memory process known as reconsolidation. In fear conditioning, a conditioned~     stimulus (CS) is paired with an aversive unconditioned stimulus (US) such as an electric~     shock, until presentation of the CS alone comes to elicit a fear conditioned response (CR).~     The investigators hypothesize that by using a more highly prepared CS (i.e. video of~     spiders); more sensitive subjects (individuals with stronger acquired CRs); and additional~     experimental probes for the presence of the latent CR, the investigators may develop a normal~     human paradigm that is not plagued by previously observed floor effects (i.e. intervention is~     100% effective), within which both the established techniques of propranolol and delayed~     extinction will produce significant, but only partial, CR reduction. This would leave room to~     test and compare potentially more powerful candidate reconsolidation-blocking or~     memory-updating interventions. To achieve these aims, subjects will undergo a four-day fear~     conditioning and delayed extinction protocol. Skin conductance response data will be gathered~     across the different phases of the experiment.~   "
147815|NCT01631669|"~     Hypotheses:~      H1: Celecoxib, when given less than five days after injury will result in a statistical~     decrease in the incidence and/or severity of radiographically apparent Heterotopic~     Ossification when compared to controls.~      H2a: A biomarker profile will accurately predict which patients in the treatment group will~     respond to Celecoxib prophylaxis for Heterotopic Ossification.~      H2b: A biomarker profile will accurately predict which patients in the control group are at~     highest risk of developing Heterotopic Ossification~   "
147816|NCT01631656|"~     This is a single center, open-label, split-face, prospective study of ten to fifteen subjects~     seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will~     be screened for eligibility for vascular laser therapy outside of the confines of this~     protocol. Once approved for laser, subjects will be screened for study enrollment and topical~     treatment of their rosacea at the Screening/Baseline visit. All subjects will receive Finacea~     15% gel and will be instructed to apply the study drug to one half of the face, twice daily.~     Drug application will be modified just prior to and after the subjects' laser treatment to~     reduce irritation. Subjects will undergo Vascular Nd:Yag laser therapy to involved areas over~     the whole face two weeks after initiating Finacea treatment. Subjects will continue to use~     Finacea gel to one half of the face for the duration of the study.~   "
147817|NCT01631643|"~     Evaluation of the clinical benefits of One Touch VerioIQ system.~   "
155203|NCT01534793|"~     This observational study aims at describing the learning curve of the Holmium Enucleation of~     the Prostate (HoLEP) technique using a LUMENIS laser device by senior attending urologists.~   "
147818|NCT01631630|"~     Background:~      - Drinking too much alcohol can injure cells in the body. Inflammation is the body s reaction~     to injured cells. Studies show that inflammation can cause cravings for alcohol. Researchers~     want to see if pioglitazone, a drug that decreases inflammation, can reduce alcohol craving.~     If so, it might help develop new ways to help alcoholics with craving.~      Objectives:~      - To see if pioglitazone can reduce alcohol craving.~      Eligibility:~      - Adults between 21 and 65 years of age who are alcoholic and have been drinking within the~     past month.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will also be collected.~        -  All participants will have inpatient treatment at the National Institutes of Health~          Clinical Center for the 5 weeks of the study. They will have standard treatment for~          alcoholism during their inpatient stay.~        -  Half of the people in this study will have pioglitazone. The other half will have a~          placebo.~        -  Participants will have different studies during their stay. These studies will include~          the following:~        -  Personalized audio recordings of stressful, alcohol-related, and neutral events to~          monitor mood~        -  Imaging studies to test alcohol cravings~        -  Questionnaires about mood and alcohol cravings~        -  Lumbar puncture to collect spinal fluid~        -  Inflammation test to see if the study drug can block alcohol cravings~        -  After the end of the 5-week study, all participants will be offered follow-up outpatient~          care through the Clinical Center, or referral to outside treatment.~   "
147819|NCT01631617|"~     Background:~      - Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have~     infections with S. aureus bacteria. Researchers want to study how eczema treatments affect~     the number and the type of bacteria on the skin.~      Objectives:~      - To study the effect of eczema treatments on skin bacteria.~      Eligibility:~        -  Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis.~        -  Healthy volunteers between 18 and 40 years of age with no history of eczema.~      Design:~        -  Participants will be screened with a physical exam and medical history. Research samples~          will be collected. Skin biopsies may also be performed.~        -  All participants will be assigned to one of several study groups.~        -  This study will last for up to 1 year. Healthy volunteers must not have taken~          antibiotics in the year before the start of the study.~        -  All participants will have regular study visits during their 1-year participation. More~          research samples will be collected at these visits.~   "
147820|NCT01631604|"~     The purpose of this study is to quantify the safety degree of the patient's gait, to detect~     the reason for the fall and quantify the biomechanical parameters related to fall. This study~     also aims to evaluate the effect of different rehabilitation treatments and their effect on~     the risk of falling.~   "
147821|NCT01631591|"~     Eosinophilic esophagitis is characterized by an eosinophilic infiltration of the esophagus.~     It presents clinically with a variety of symptoms including dysphagia, emesis, and food~     impaction. Although the underlying mechanism is different, gastroesophageal reflux can~     present with similar clinical findings but can be distinguished from eosinophilic esophagitis~     by the number of eosinophils present on esophageal biopsy. In children, food allergies play a~     role in exacerbating eosinophilic esophagitis, but the role of food allergies in adults is~     uncertain. In this study, we aim to determine the prevalence of food allergies in a cohort of~     adults with eosinophilic esophagitis.~   "
147822|NCT01631578|"~     A prospective randomized controlled trial (RCT) to determine the effect of injecting an~     autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into~     oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.~   "
147823|NCT01631565|"~     There is recent evidence that early palliative care administered to patients helps for their~     quality of life (QoL). It is however not part of the standard multidisciplinary treatment.~      This study intents to evaluate the effect of early palliative care in patients with advanced~     Non-Small Cell Lung Cancer (NSCLC) compared to the standard of care.~   "
147824|NCT01631552|"~     The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single~     agent administered in 3-week treatment cycles for up to 8 cycles, in previously treated~     patients with advanced epithelial cancer.The secondary objectives are to obtain initial data~     concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. IMMU-132~     targets the TROP-2 antigen which is expressed on a variety of cancers. The antibody, RS7, is~     attached to SN38, which is the active metabolite of irinotecan. This is planned as a~     multi-center study. In Phase II, up to 130 patients (assessable) in triple-negative breast~     cancer, up to 100 patients (assessable) in non-small cell and small-cell lung cancer and up~     to 50 patients (assessable) per other cancer types included in the protocol will be studied~     at the 10 mg/kg dose.~   "
147825|NCT01631539|"~     The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded~     with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for~     wildtype KRAS unresectable liver metastases from colorectal cancer.~   "
147826|NCT01631526|"~     Hypovitaminosis D is highly prevalent in people with lung cancer, and may have adverse~     clinical consequences. The long and variable pharmacokinetic half-life of vitamin D makes~     prompt vitamin D replacement problematic. This is an open, one-armed therapeutic intervention~     using a loading dose of vitamin D that will be predicted to increase plasma 25-hydroxyvitamin~     D concentrations of every patient well into the normal range (> 100 nmol/L) within 2 or 3~     weeks and monitored after 2 and 3 weeks of loading and maintenance dose. Preliminary data~     will also be obtained to identify potentially clinical important outcome benefits for future~     investigation. The outcomes are~        1. plasma 25OHD concentration~        2. Vitamin D binding protein and other plasma concentrations~        3. Mood and symptom~   "
147827|NCT01631513|"~     The purpose of this study is to evaluate tapentadol Extended Release (ER) in the treatment of~     moderate to severe chronic pain in participants with a diagnosis of chronic low back pain~     (LBP) or osteoarthritis (OA) of the hip or knee after conversion from hydrocodone, oxycodone~     Controlled Release (CR), and/or morphine Sustained Release (SR).~   "
147876|NCT01630876|"~     This study compares the anatomical and visual outcomes of patients with idiopathic epiretinal~     membrane(ERM) treated by vitrectomy and membrane peeling with or without subtenon~     triamcinolone acetonide injection~   "
147877|NCT01630863|"~     To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment~     of central serous chorioretinopathy.~   "
147828|NCT01631500|"~     Minor mental health problems, MMHP, like mild depression and anxiety, and medically~     unexplained symptoms, MUS, symptoms with no known underlying organic disease, are strongly~     associated to each other. MMHP and MUS have an impact on well-being and quality of life, lead~     to impaired social and cognitive function and could result in reduced work capacity. The~     investigators have designed the present study as a pragmatic trial to investigate the~     effectiveness of an integrative treatment model, therapeutic acupuncture, versus conventional~     treatment in patients with MMHP or MUS in primary care. The investigators examined whether~     the effects of the integrative treatment model differed from those achieved with therapeutic~     acupuncture or conventional treatment. Primary endpoints were anxiety and depression~     (assessed with the Hospital Anxiety and Depression scale), health-related quality of life~     (SF-36) and coping with stress, sense of coherence (SOC) during the eight weeks of treatment~     interventions.~      Statistical power was calculated based on an expected 50% reduction in HAD anxiety and~     depression scores after eight weeks of integrative treatment; a 30% reduction in acupuncture;~     and 20% in conventional care. A total of 120 (40/arm) were needed to achieve a power of 83%~     at p <0.05. Treatment effects were calculated as the difference between values at baseline,~     after four weeks and after the complete intervention period, i.e. after eight weeks.~     Nonparametric analyses were carried out to test differences between independent samples~     (Kruskal-Wallis and Mann-Whitney U) and related samples (Wilcoxon).~   "
147829|NCT01631487|"~     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of~     JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in~     healthy Japanese adult male participants in Part 2.~   "
147830|NCT01631474|"~     CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent~     skin disorder. The purpose of this study is to compare the safety and efficacy of multiple~     concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.~   "
147831|NCT01631461|"~     The aim of this study is to investigate the prevalence of yeast and bacteria in women with~     breastfeeding pain and to identify signs and symptoms.~   "
147832|NCT01631448|"~     Globally there have been about 45,000 kidney transplants last year. Currently, the overall~     survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major~     challenge to overcome by the renal transplant surgeons, are surgical complications which may~     impact on patient morbidity and mortality, as well as graft function.~      The aim of the study is to assess whether application of fibrin seal prevents postoperative~     complications in patients undergoing kidney transplantation.~      Controlled clinical trial with single-blind evaluation in patients surgically intervened~     kidney transplantation. It will include all patients undergoing renal transplantation in this~     Medical Center, any gender and over than 16 years and under 60 years.~   "
147833|NCT01631435|"~     This is a prospective, multi-center (up to 6 sites) study which aims to To establish the~     effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by~     visualizing the small bowel and colon in patients with active symptoms associated with~     Crohn's disease (CD).~   "
147834|NCT01631422|"~     This single-center, open-label study will investigate the pharmacokinetics and elimination of~     a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers~     will receive a single oral dose of RO4602522.~   "
147835|NCT01631409|"~     This study is dedicated to determination of the long term effectiveness of coronary heart~     disease (CHD) treatments - cardiac shock wave therapy (CSWT) in comparison with other kinds~     of medical and surgical treatment. For that purpose the investigators will observe the~     patients with CHD who enrolled in this study in their routine course of treatment. But the~     investigators will not interfere with the patient treatment. Each participant will be~     followed-up for five years. The collected data will allow to determine if the particular~     method, CSWT, could really make any additional contribution to the more traditional methods~     of CHD treatment and if the CSWT is only temporarily effective or could exert the long term~     effect as well.~   "
147836|NCT01631396|"~     The study is a prospective, single center, double arm study aiming at the comparison of 2~     commercial neuromuscular block reversal drugs: Neostigmine (Cooper S.A.) and Sugammadex~     (MSD). A faster recovery from neuromuscular block is expected for patients receiving~     Sugammadex and this protocol is of high importance for anesthesia of morbid obese patients~     during bariatric surgery.~   "
147837|NCT01631383|"~     This study will test the safety and pharmacokinetic profile of l-THP with cocaine exposure in~     people who have a history of cocaine use. The subject will be admitted to the Brief Stay Unit~     (BSU), an inpatient facility at the Maryland Psychiatric Research Center, used for short term~     drug abuse or clinical trial studies. The participant will stay for 4 nights and 5 days.~     He/she will be randomized to either placebo or l-THP for three days. On the morning of Day 4,~     the subject will receive one cocaine dose (40 mg intranasal) and have testing for~     pharmacokinetic parameters for the following 10 hours. The subject will stay over one more~     night and will be discharged the following day. Approximately 40 subjects will be randomized~     to enroll the target sample of 30 (N=15 placebo, N=15 l-THP). In summary, each subject will~     come for a screening visit(s), then a 5-day, 4-night stay on a secure research unit. After~     cocaine administration day, the participant will stay overnight for one more day of~     observation and to permit substantial l-THP elimination from the body. The following morning~     we will get one additional blood specimen for l-THP (Day 5 at 24 hours after last dose (7:30~     am); then the participant will be discharged. A visit with blood collection on Day 6 at 55~     hours after last dose (2:30 pm) will be scheduled. A final follow-up visit will be scheduled~     4-7 days after unit discharge to ensure no persisting side effects.~   "
147838|NCT01631370|"~     Renal sympathetic nerves contribute to development of hypertension. Sympathetic overactivity~     also induces insulin resistance and it could therefore be assumed that a renal denervation~     might improve insulin sensitivity. Studies have shown that glucose metabolism is improved in~     patients with treatment resistant essential hypertension both 1 and 3 months after renal~     denervation compared to a control group with treatment resistant essential hypertension.~     Fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance~     assessed by HOMA-IR. The investigators wish to investigate the effect of renal denervation on~     insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and to~     investigate the degree of insulin resistance in muscle, liver and adipose tissue.~   "
147840|NCT01631344|"~     Background:~      Low back pain is the leading cause of disability, affecting the quality of life and work~     productivity.~      It is the most common reason for seek medical help and advice. Low back pain creates huge~     economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically~     defined with no preferred medical treatment~        1. Study objectives:~           To prove that consulting using the Stage of change model for daily physical activity~          will lead to long term improvement of pain, disability and well-being parameters of~          those suffering from chronic low back pain, people age 25-55, when compared to~          conventional Physical Therapy.~        2. Study hypotheses:~           The intervention groups vs. Physical Therapy group will demonstrate that the following~          parameters will improve after: 3 months, one, two and five years.~             1. Pain reduction.~             2. Less disability - improvement in daily activities.~             3. Better feeling of health and well-being.~             4. Increased and better compliance to daily sport activities.~             5. BMI reduction.~             6. Reduction of cigarette smoking.~             7. Reduction of usage of anti-analgesics and anti-inflammatory medications.~             8. Reduction in number of visits to Physical Therapy clinics due to low back pain.~        3. Methods:~      The present Randomized intervention study that will include 220 healthy individuals, males~     and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or~     without radiation to the legs that were referred to Maccabi Healthcare Services Physical~     Therapy clinics in the Sharon district in Israel.~      These individuals will be randomized to one of the following two groups:~        1. Conventional Physical Therapy.~        2. Physical Therapy focused on healthy lifestyle using the Stage of Change model.~      Non-dependent observer will follow-up on the outcome parameters via phone calls and filling~     the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5~     years.~   "
147841|NCT01631331|"~     The purpose of this study is to learn about the effect of vismodegib on sporadic basal cell~     carcinoma (BCCs) prior to surgical removal.~   "
147842|NCT01631318|"~     Patients are invited to participate in a research study of liver perfusion (how blood flows~     to the liver over time). Researchers hope to learn whether perfusion characteristics of liver~     metastases may be predictive of response to treatment and whether liver perfusion~     characteristics can be used to follow response to treatment. Patients were selected as a~     possible participant in this study because they are identified as having liver metastases~   "
147843|NCT01631305|"~     The purpose of this study is to determine whether levothyroxine is effective and safe in the~     treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive~     care unit.~   "
147844|NCT01631292|"~     In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese~     women, and hypothesize that it will not affect areal BMD, but will alter bone compartments~     (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum~     25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes~     include the influence of vitamin D and weight loss on markers of insulin resistance and on~     cognitive tests of attention, learning, and memory.~   "
147845|NCT01631279|"~     The purpose of this study is to determine the Maximum Tolerated Dose and the Dose-Limiting~     Toxicity of the drug to further evaluate safety and antitumor activity.~   "
147846|NCT01631266|"~     Tuberculosis (TB) continues to be the most important bacterial infection worldwide and~     therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.~      We are investigating a new skin test named C-Tb. Like the current tuberculin skin test (PPD),~     the C-Tb test is injected just under the skin and will, when positive, show redness and/or~     swelling at the injection site while a negative test will leave no reactions.~      The aim of this trial is to test the C-Tb skin test in volunteers. The volunteers are divided~     into four groups:~        -  Negative control group: Must have no history of exposure to a person with tuberculosis~          disease.~        -  Occasional contact: Must be in contact with a person with tuberculosis disease between 6~          hours/week and 6 hours/day~        -  Close contact: Must be in close contact with a person with tuberculosis disease for more~          than 6 hours/day for at least five days~        -  Positive control group: Must have a confirmed tuberculosis disease within the last 3~          years.~      The goals of this clinical trial are:~        -  To compare the C-Tb test to a blood test, the QuantiFERON test.~        -  To compare the C-Tb test to the PPD test that is currently being used.~        -  To assess the safety of the C-Tb test.~   "
147847|NCT01631253|"~     The purpose of this study is to investigate the impact on ovarian reserve after single- port,~     two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti~     mullerian hormone change.~   "
147848|NCT01631240|"~     This proposed calibration study is designed to evaluate the correlation of urinary sodium~     excretion between NHANES timed urine and 24-hour urine collections.~   "
147849|NCT01631227|"~     Aim of this study is to compare the blood pressure lowering effect of a new drug formulation~     of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide~     since years with proven efficacy. The new formulation is compared to the currently marketed~     eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be~     demonstrated.~   "
147850|NCT01631214|"~     The purpose of this study is to determine if treatment is effective in preventing fractures~     in women with postmenopausal osteoporosis~   "
147851|NCT01631201|"~     This study will test the safety and effectiveness of an investigational antibiotic drug,~     rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This~     study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1~     gram, which will be given as a single dose to women who have genital chlamydial infection.~   "
147852|NCT01631188|"~     The study is being done to determine if the Endovent pulmonary catheter kit, used for port~     access surgery, can be used as a passageway for a pacing wire. The study hypothesis is that~     the Endovent kit can be used effectively as a passageway for a pacing wire system.~   "
147853|NCT01631175|"~     Aim of this study is to develop and establish an indication-based algorithm for identifying~     particular stress patterns of patients with initial diagnosis of a sarcoma or a metastatic~     bone disease. A further aim was the establishment of an adequate psychosocial treatment~     within the clinical workday routine to support coping with illness and treatment.~   "
147854|NCT01631162|"~     The investigators assume that by analysis of different volatile organic compounds in the~     breath, using nanotechnology, the investigators will be able to identify a unique respiratory~     signature of different diseases including asthma, chronic obstructive pulmonary disease~     (COPD) and pulmonary hypertension.~   "
147878|NCT01630850|"~     The purpose of this study is to learn about the safety of islet transplantation for Type 1~     diabetes mellitus, which may provide more normal control of blood sugar without the need for~     insulin shots. Islets are special clusters of cells within the pancreas that produce insulin.~     These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.~   "
147879|NCT01630837|"~     The purpose of this study is to evaluate the frequency of oral hygiene in the maintenance of~     gingival health in patients with an adequate method of oral hygiene.~   "
147855|NCT01631149|"~     Rationale: A deep neuromuscular block is often associated with improved surgical conditions~     especially in laparoscopic surgery. However, a deep block comes at the expense of a variety~     of items that may conflict with the use of a deep surgical muscle blockade including a long~     recovery phase, the need for muscle reversal, postoperative ventilation, impaired~     postoperative breathing. With the introduction of Sugammadex there is now the possibility to~     reverse an even deep surgical block. This may overcome most if not all of the issues~     mentioned.~      Objective: To assess whether a deep neuromuscular block provides better surgical conditions~     than a moderately deep block as derived from a surgical rating score.~      Study design: Single center, double-blind randomized controlled trial. Study population: 24~     ASA I-III patients scheduled for laparoscopic renal (n=12, GROUP 1) or prostatic surgery~     (n=12, GROUP 2).~      Intervention: In both GROUP 1 and GROUP 2, 6 six patients will receive neuromuscular blockade~     according to current practice (atracurium (bolus) plus mivacurium (cont. infusion)) aimed at~     a moderately deep neuromuscular block (1-2 twitches in the Train of Four (TOF) monitor). The~     other six will receive a bolus plus continuous infusion with rocuronium aimed at a deep~     neuromuscular block (1-2 twitches post tetanic count (PTC)). All surgical procedures will be~     performed by one surgeon.~      Main study parameters/endpoints: To study the surgical conditions in patients undergoing~     laparoscopic renal or prostate surgery during deep versus less deep neuromuscular block as~     assessed by the surgical rating score.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Compared to current practice there will be no additional risk.~   "
147856|NCT01631136|"~     In France, lung cancer is responsible for more than 30000 each year. Progress was made in~     treatment of lung cancer in the last five years due to targeted therapies and to strategical~     evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of~     this strategical evolution. It is based on maintaining continuous therapeutical pression in~     order to preserve the therapeutical benefit obtained by the first line (induction~     chemotherapy). Several clinical trials showed that maintenance strategies increase the~     duration of controlled disease.~      There is two types of maintenance strategies:~        -  Continuous maintenance : prolongation of the treatment initially associated with platin~          until progression~        -  Switch maintenance : introduction of a new treatment after the end of induction~          chemotherapy~      The aim of this study is to compare two maintenance strategies~        -  A continuous maintenance by pemetrexed~        -  A switch maintenance or a continuous maintenance according to the response of induction~          chemotherapy.~   "
147857|NCT01631123|"~     This is an intervention study in healthy adult twins with the aim to investigate the genetic~     determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet~     versus an isocaloric low carbohydrate, high fat diet.~   "
147858|NCT01631110|"~     The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills~     the EMA requirements for re-registration of influenza vaccines.~   "
147859|NCT01631097|"~     This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics,~     safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of~     hepatic impairment and normal hepatic function.~   "
147860|NCT01631084|"~     In this demonstration project (Asia Pacific JADE and DIAMOND Program, AP-JD in short)~     supported by the Asia Diabetes Foundation (ADF), patients will be recruited from different~     sites across Asia, with each site recruiting at least 600 type 2 diabetic patients. After~     explanation by trained doctors and nurses, and with written informed consent, patients will~     be randomized to either the JADE (n=300, structured care) or DIAMOND (n=300, usual care)~     group.~      All patients will undergo a comprehensive assessment (CA) at baseline and yearly thereafter.~     Patients in the JADE group will be further managed by a doctor-nurse-HCA team according to a~     protocol based on risk stratification with predefined follow up (FU) schedules together with~     shared information and decision support (i.e. structured collaborative care). The DIAMOND~     protocol involves only baseline and yearly CA without predefined FU schedules or feedback of~     information between CA visits (i.e. usual care).~      The primary composite endpoint is all-diabetes related clinical endpoints. The secondary~     composite endpoint is attainment of treatment goals and/or control of risk factors. The~     tertiary changes are behavioral changes, psychological well being and quality of life.~   "
147861|NCT01631071|"~     The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills~     the EMA requirements for re-registration of influenza vaccines.~   "
147862|NCT01631058|"~     An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus low~     tacrolimus for the immunosuppression in renal transplantation in the elderly.~      To evaluate the pharmacokinetics of immunosuppressants that have been little studied in this~     population.~      To evaluate whether the polymorphism of the genes that determine the expression of~     metabolizing enzymes and transporters of xenobiotics interfere in the elderly, also in the~     younger population, absorption and metabolism of immunosuppressants.~      To evaluate the potential minimization of immunosuppression in this population refers to how~     does the re-population of peripheral lymphocytes, in this age group, after the use of~     lymphocyte-depleting agents such as thymoglobulin and subsequently maintained with two~     regimes.~      Clarify which markers of renal filtration exist today, cystatin C and serum creatinine, is~     the right to monitor renal function in elderly transplanted.~   "
147863|NCT01631045|"~     Scientists have studied how fasting and nutrients affect brain function in animals. The~     purpose of this study is to look at the effects of both fasting and food intake on brain~     function and memory in humans. To do this the investigators will use functional MRI to~     observe the brain and its function while fasting and after a meal. Understanding the action~     of these hormones in the brain may eventually lead to new ways to help people avoid obesity~     or lose weight.~   "
147864|NCT01631032|"~     Allergic rhinitis is a common but complicated immunologic disorder disease and multiple~     western medicine has been used for symptom control. Chinese herbal medicine, one of the most~     commonly used complementary and alternative medicine in Taiwan, has also be used for allergic~     rhinitis control. This study is designed to explore the efficacy and possible underlying~     immune-modulation effect of the BZYQT, which is one of the most famous Chinese herbal~     medicine used for allergic rhinitis in daily practice.~   "
155401|NCT01532115|"~     The purpose of this study is to evaluate the effect of BIA 9-1067 on the cardiac~     repolarization in adult healthy men and women volunteers.~   "
147865|NCT01631019|"~     Background: Moderate-intensity exercise training improves skeletal muscle aerobic capacity~     and increased oxidative enzyme activity, as well as exercise tolerance in Chronic Obstructive~     Pulmonary Disease (COPD) patients.~      Design: To investigate the home-based exercise training program can reduce inflammatory~     biomarkers in COPD.~      Setting: Conducted from January 2007 to December 2007 at a tertiary medical center, Chang~     Gung Memorial Hospital, Taiwan.~      Patients: Moderate to severe COPD receiving home exercise training, 12 using mobile phone~     assistance and 14 with free walk, were assessed for 6 months.~      Measurements: Incremental shuttle walk test (ISWT), spirometry, strength of limb muscles,~     C-reactive protein (CRP) and inflammatory cytokines.~   "
147866|NCT01631006|"~     Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of~     disability including heart failure, atrial fibrillation, and sudden death, with an annual~     mortality varying from 1% to 6%. Obstructive sleep apnea (OSA) is extremely common among~     patients with established cardiovascular disease, including hypertension and atrial~     fibrillation and when present may contribute to worse cardiovascular outcome. Although~     patients with HCM do not necessarily have typical characteristics of patients with OSA, such~     as obesity and increasing age, there is recent evidence that OSA is extremely common among~     patients with HCM, with a prevalence ranging from 32% to 71%. The presence of OSA among~     patients with HCM is independently associated with worse structural and functional impairment~     of the heart, including atrial and aorta enlargement, worse New York Heart Association~     functional class, and worse quality of life. Therefore, the recognition and treatment of OSA~     is a new area of research that may impact in the management of patients with HCM.~   "
147867|NCT01630993|"~     The purpose of this pilot study is to determine if umbilical cord milking at the time of~     scheduled cesarean section effects the hemoglobin and hematocrit levels of full-term infants~     as determined by hemoglobin and hematocrit levels at 36-48 hours of life. This study will~     help to establish the feasibility of umbilical cord milking as an alternative to delayed~     clamping at the time of planned cesarean section.~   "
147868|NCT01630980|"~     Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts,~     pistachios and walnuts) are an important source of unsaturated fatty acids, vegetable~     protein, and fibre, as well as minerals, vitamins, and phytonutrients. Although heart disease~     risk reduction claims for nuts have been permitted in the U.S. and general dietary guidelines~     and recommendations from heart associations recommend the consumption of nuts for heart~     protection, diabetes associations have not addressed nuts in their most recent~     recommendations. This omission is despite heart disease being a major cause of death in~     diabetes. There remains insufficient information on the usefulness of these foods in~     diabetes. To improve evidence-based guidance for tree nut recommendations, the investigators~     propose to conduct a systematic review of the effect of tree nuts on diabetes control and~     features of the metabolic syndrome. The systematic review process allows the combining of the~     results from many small studies in order to arrive at a pooled estimate, similar to a~     weighted average, of the true effect. The investigators will be able to explore whether~     eating tree nuts has different effects between men and women, in different age groups and~     background disease states, and whether or not the effect of tree nuts depends on the dose and~     background diet. The findings of this proposed knowledge synthesis will help improve the~     health of Canadians through informing diabetes association recommendations and heart~     association recommendations where they relate to diabetes.~   "
147869|NCT01630967|"~     Men with castrate resistant prostate cancer who are switched from a luteinizing~     hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in~     prostate-specific antigen (PSA).~   "
147870|NCT01630954|"~     Hydatidiform mole is a common complication of pregnancy with an incidence of 1in 400~     pregnancies in India. Although this is a benign condition , it is having the malignant~     potential too. A repeat curettage after evacuation of hydatidiform mole was generally~     advocated till 1990s. A thorough curettage at the time of initial evacuation was not~     performed because of larger size of uterus and risk of perforation. Subsequently a number of~     studies assessed the usefulness of repeat curettage and found it was unnecessary and not cost~     effective . However all these studies are retrospective in design and conducted in developed~     countries where hydatidiform mole is diagnosed earlier because of wider use of~     ultrasonography. Thus there is a need to perform a well designed prospective study to compare~     the effectiveness of single evacuation with double evacuation in treatment of hydatidiform~     mole for prevention of Gestational Trophoblastic Neoplasia.This study compares the~     effectiveness of single evacuation versus double evacuation for treatment of hydatidiform~     mole for prevention of gestational trophoblastic neoplasia .~   "
147871|NCT01630941|"~     The primary objective is to study the effect of Denosumab on Bone Mineral Density,~     Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The~     primary hypothesis is to demonstrate that Denosumab is superior to placebo.~   "
147872|NCT01630928|"~     The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is~     done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive,~     percutaneous technique where an ablation catheter is inserted through a femoral artery into~     the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia~     by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys,~     which in the Symplicity trials led to an impressive reduction of blood pressure (- 33 /-11~     mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have~     beneficial effects not only on blood pressure, but also on insulin sensitivity and~     hyperinsulinaemia.~      The investigators aim to introduce RDN as a clinical study where blood pressure reduction and~     methodical, technical aspects will be evaluated, but more importantly, also additional~     effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness,~     fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The~     investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL and~     sub-clinical organ damage.~   "
147873|NCT01630915|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 ×~     75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a~     washout period of 7 days.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
147880|NCT01630824|"~     Kidney transplantation is the treatment of choice for patients with end-stage renal disease.~     The purpose of this randomized and controlled study is to evaluate the efficacy of a~     structured education program for adult kidney transplant recipients. Patients are randomly~     assigned to an educational program or to a standard care control group. The education group~     receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney~     transplantation. Kidney transplant survival, number of rejections, infectious complications,~     length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life~     (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators~     postulate that the education group will have superior outcomes compared to the control group.~   "
147881|NCT01630811|"~     Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by~     the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8~     weeks over subjects given placebo.~      Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt~     Aggression Scale (OAS).~   "
147882|NCT01630798|"~     You are invited to participate in a research study to develop new ways to look for abnormal~     areas/tissues of the esophagus. The current endoscopes used to look at the esophagus are very~     good, but if the area doesn't look different to the naked eye, then the endoscope can't~     improve on that. The investigators are looking at using special fluorescent stains in~     addition to special endoscopes designed to see abnormal areas that are not obvious to the~     naked eye. Currently specialized microscopes and fluorescent stains are used in clinical~     laboratories but it takes several days of processing to get results. It may be very helpful~     to look for areas to sample for abnormal tissue during the endoscopy procedure.~      You are being asked to let us use fluorescent peptides with a special endoscope that allow~     us to see your esophagus with both fluorescent and white light during your upper GI~     endoscopy procedure to help target your biopsies. Peptides are small chains of amino acids~     (the building blocks that make up proteins) linked together. Our peptide is a chain of 7~     amino acids attached to a fluorescent dye called FITC (like the one used by your eye doctor).~      The investigators have prepared special fluorescent peptides, that will glow when a~     special light is used that should help us separate normal tissue from abnormal tissue. In~     this study, the investigators will apply the special fluorescent peptides by a spray catheter~     to your esophagus to help us target you biopsies. Both routine and targeted biopsies will be~     taken as your endoscopist feels is indicated.~      This is a phase 1b study. This means that although the investigators have applied the peptide~     to 25 people in our first research study, the investigators still need to learn more about~     fluorescent peptide in people. The Food and Drug Administration (FDA) has not approved this~     agent, but is allowing us to test it in this study. The main goal of this study is to see if~     the peptide glows well and if the investigators can take pictures of the areas that do~     glow.~      This is a research study of the peptide and our ability to see it light up or fluoresce.~     Being in this study and applying this peptide won't change how your biopsies are taken nor~     how your endoscopy is done.~   "
147883|NCT01630785|"~     The investigators record the outcome of patients whose surgery involved intraoperative~     neurophysiological monitoring~        -  Trial with surgical intervention~   "
147884|NCT01630772|"~     The aim of this study is to evaluate the influence that has a physical therapy protocol in~     maternal and fetal hemodynamics in relation to blood pressure, maternal and fetal responses~     and perinatal outcomes.~   "
147885|NCT01630759|"~     When women with diabetes become pregnant it is particularly important to control blood sugar~     levels to prevent complications. Women are advised to test their blood glucose levels seven~     times a day and to attend antenatal and diabetes clinics every 1-2 weeks throughout the~     pregnancy. For those living in rural areas in the North and West of Ireland getting to a~     hospital specialising in the management of diabetes and pregnancy on such a regular basis can~     be a challenge.~      Telemonitoring provides a possible solution to this problem by allowing patients to monitor~     their vital signs at home and transmit the information via telephone to their healthcare~     provider. If women could be safely monitored remotely for every other appointment it would~     mean that they would only need to visit the hospital once a month on a routine basis but with~     the option of attending the hospital if the remote telemonitoring indicated that this were~     necessary.~      The aim of this study is to assess the feasibility and the acceptability of using remote~     telemonitoring facilities between antenatal women with gestational diabetes and the diabetes~     team and the possibility of replacing alternate diabetic review clinics with remote~     telemonitoring. In addition this study will explore the feasibility of running a full~     randomised control trial of this topic.~      Women will be asked to monitor their blood sugar levels seven times a day which is part of~     usual care. However those in the remote telemonitoring group will be asked to measure their~     blood sugar using a meter that can transmit the results via a telephone line and to transmit~     them weekly. They will also be asked to measure their blood pressure and weight weekly and to~     download these results weekly for a health care professional to review. These results will be~     reviewed on a weekly basis by a health care professional who will contact the patient if~     necessary to discuss the results. Women will be followed-up from the date of diagnosis~     through to delivery.~      Both staff and patients will be asked to give their views on the safety and acceptability of~     remote telemonitoring through questionnaires, focus groups or interviews. The management~     decisions made on reviewing the intervention group in clinic and reviewing remote~     telemonitoring results will also be recorded. In order for remote telemonitoring to be a~     viable replacement for clinic review it must allow health care professionals to make~     comparable management decisions. Clinical data will be collected in order to provide~     descriptive statistics for those who take part and to ensure that this information could be~     collected in any future Randomised Control Trial (RCT) looking at this topic.~   "
147886|NCT01630746|"~     The purpose of this study is to evaluate the acid-inhibitory and dose-response efficacy of~     TAK-438 (20 mg, 40 mg) in patients with PPI-resistant erosive esophagitis.~   "
147887|NCT01630733|"~     The primary objective of the study is to compare overall survival of patients randomized to~     receiving custirsen in combination with docetaxel (Arm A) with patients randomized to receive~     docetaxel alone (Arm B).~   "
147888|NCT01630720|"~     There is a high prevalence of hypovitaminosis C and D in our hospital and other acute-care~     hospitals. Since the correction of these presumed deficiency states is simple, safe and~     inexpensive, their documented or suspected presence would normally be considered sufficient~     indication to correct them. However, the common practice is to ignore them. Identification of~     specific measurable medical consequences of hypovitaminosis C or D would provide a stronger~     case to treat or prevent in-hospital vitamin deficiency states.~      Biochemical deficiencies of vitamin C and D have both been linked to mood disturbance, and~     hypovitaminosis C reportedly increases blood histamine concentrations.~      We recently found that the provision of vitamin C (500 mg twice daily) but not vitamin D~     (1000 IU twice daily) promptly improved the average mood score of acutely hospitalized~     patients. We will now conduct a closely similar randomized clinical trial using a more~     adequate dose of vitamin D, namely 5000 IU/day for up to 10 days.~   "
147889|NCT01630694|"~     The purpose of this study is to identify differences in craniofacial morphology and tongue~     size between patients who have a history of difficult airway management and a control group~     of patients who had an uneventful airway management during induction of general anesthesia.~     In this study the investigators want to validate the hypothesis that there are craniofacial~     phenotypic differences between patients who have a history of difficult airway management and~     a control group of patients who have had an uneventful airway management during the induction~     of general anesthesia.~   "
147955|NCT01629823|"~     The CPAP trial is a 3-arm parallel design randomized sham-controlled trial. Participants are~     randomly assigned in equal allocation to one of three treatments: CPAP 10 cm water (H₂O)~     (high) vs. CPAP 5 cm H₂O (medium) vs. CPAP Sham (less than 1 cm H₂O, Low). The treatment~     period is 12 weeks with airways reactivity assessed at baseline, 6 and 12 weeks of treatment~     and after a 2 week washout.~   "
147956|NCT01629810|"~     The purpose of this study is to test the effectiveness of whole body periodic acceleration~     for helping with symptoms of aches and pains suffered by many patients.~   "
147890|NCT01630681|"~     The aim is to evaluate the effects of Internet based Stepped Care on anxiety, depression and~     health related quality of life in cancer patients with anxiety and depression symptoms,~     compared to Standard Care, and to evaluate the health-economic effects of the intervention.~     The investigators also want to examine the development of anxiety and depression symptoms and~     health related quality of life in cancer patients without initial symptoms.~      The primary hypothesis is that Internet based Stepped Care (I-SC) is more effective in~     relieving anxiety and depression symptoms in cancer patients, compared to Standard Care (SC).~     Secondary hypotheses are that less anxiety and depression symptoms also means improved health~     related quality of life and that I SC is cost-effective or at least cost neutral compared to~     standard care.~      The IT-platform Carebase.se is developed within U-CARE. The platform will be used for~     delivering of interventions and for collection of all patient reported outcomes. Patients~     with anxiety or depression symptoms according to the Hospital Anxiety and Depression Scale~     will be randomized to I SC or SC. Patients with no initial anxiety or depression symptoms~     will be included in descriptive studies. All patients, in the randomized controlled trial and~     the descriptive study will followed up during 24 months~      I-SC comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2).~     Step 1 starts directly after randomization and extends over a 24 months period. Step one~     comprises web-based patient education including psycho-education and easy interventions~     strategies employed in CBT. Step 1 also includes a FAQ, a discussion board for patients and a~     personal diary. Project staff (nurses) is responsible for the FAQ and to moderate the~     discussion board. The nurses will be supervised by a CBT psychologist. They can also turn to~     other experts in the project group for advices about how to answer patients' questions.~      Patients with remaining anxiety or depression symptoms at 1, 4 or 7 months after~     randomization will be offered Step 2. Step 2 comprise conventional Internet based CBT for~     common psychological concerns. The participants' chooses to work with modules that correspond~     to prioritized concerns, e.g. anxiety or depression. The CBT is structured and manualized and~     include conventional treatment methods with homework and weekly contacts with the~     psychologist. Step 2 extends over a 10-week period.~   "
147891|NCT01630668|"~     Background: In recent years, probiotics have shown promise in treating a variety of diseases.~     Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri~     NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.~      Objective: The purpose of the study is to determine the lipid lowering efficacy of a~     One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12~     weeks in subjects with hypercholesterolemia.~      Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm,~     multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in period~     and a 12-week intervention period.~   "
147892|NCT01630655|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan~     Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were~     separated by a washout period of 17 days during fasting study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
147893|NCT01630642|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 ×~     75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a~     washout period of 7 days.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
147894|NCT01630629|"~     Changes in maternal calcium metabolism are necessary during lactation to provide adequate~     calcium in breast milk for development of the newborn skeleton. The calcium in milk is~     derived from the maternal skeleton, resulting in significant bone loss, a process thought to~     be mediated by the actions of parathyroid hormone-related protein (PTHrP) in combination with~     a decreased estrogen levels. After weaning, bone lost during lactation is rapidly regained.~      Differences between African-American and Caucasian bone metabolism are well documented and~     include higher bone mineral density (BMD), lower risk of fragility fracture, lower~     25-hydroxyvitamin D (25(OH) D), and higher PTH in African-Americans compared to Caucasians.~     Most studies of bone metabolism in lactating women have been done in Caucasians. Because of~     differences in bone metabolism between African-Americans and Caucasians, we do not know~     whether African-Americans will have similar findings.~      The primary aim of this study is to compare the changes in bone mineral density (BMD) during~     lactation in African-Americans with those in Caucasians. It is not known whether the loss in~     BMD during lactation will be the same for both races. African-Americans display skeletal~     resistance to PTH with short-term infusions and have lower bone resorption, higher BMD and~     lower fracture risk than Caucasians. A recent study by our group indicated that lactating~     African-American mothers had slightly lower bone resorption but quantitatively similar bone~     formation compared to Caucasians. However, there was a significant increase of 2-3 fold in~     markers of bone formation and resorption in both groups. Therefore, it is currently not known~     whether the loss in BMD during lactation will be the same for both races. Primary outcome~     measures in this study will include spine, hip and radius BMD by Dual X-Ray Absorbiometry~     (DXA)Scans during lactation (at 2,12 and 24 weeks postpartum or at weaning if prior to 24~     weeks postpartum, and six months after weaning (+1 week). This longitudinal protocol will~     distinguish between two hypotheses. Either: a) as measured by BMD, bone loss in~     African-Americans during lactation will be equal to that in Caucasians, and skeletal recovery~     will be the same or possibly accelerated compared to Caucasians; or, b) African-Americans~     will be resistant to bone loss during lactation compared to Caucasians because of resistance~     to Parathyroid Hormone-related Protein (PTHrP).~   "
147895|NCT01630616|"~     This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of~     single doses of odanacatib in mature adolescents and young adults who are currently receiving~     glucocorticoid therapy. The primary hypotheses for the study are that a single dose of~     odanacatib is well tolerated in mature adolescents and following single dose administration~     of odanacatib 50 mg, there is no clinically important difference in AUC0-inf between mature~     adolescents and young adults.~   "
147896|NCT01630603|"~     Objectives:~        1. To determine the incidence of vitamin D deficiency among Israeli pregnant women~        2. To access whether maternal vitamin D status affects infant bone strength.~      Methods:~        1. Vitamin D levels -in cord blood and maternal blood~        2. The mother will fill a demographic and nutritional questionnaire~           The Infants:~        3. Growth assessment of the infants: weight length and head circumference~        4. Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)~   "
147897|NCT01630590|"~     The goal of this clinical research study is learn if adding cabozantinib (also known as~     XL184) to hormonal therapy can help to control prostate cancer. The safety of this drug will~     also be studied.~      Cabozantinib is designed to block certain proteins in your blood that cause cancer cells to~     grow. This may cause cancer cells to die.~   "
147898|NCT01630577|"~     We conducted this study to assess the value of early change in central venous pressure (CVP)~     in predicting fluid responsiveness in mechanically ventilated patients.~   "
147899|NCT01630564|"~     The goal of this clinical research study is to learn about the highest tolerated dose of T~     cells that can be safely given to patients whose cancer has returned after a UCBT.~   "
147900|NCT01630551|"~     Ocular surface disease (OSD) is a significant health problem that affects more than 10~     million persons in the United States alone. OSD is highly prevalent among medically treated~     patients with glaucoma and is associated with the number of intraocular pressure~     (IOP)-lowering medications used.~      The purpose of this study is to determine the potential effectiveness of anoritega-3 fatty~     acid nutritional supplement in the treatment of ocular surface disease associatedwith the~     use of glaucoma eye drops~   "
147901|NCT01630538|"~     The study hypothesis is that short-term low dose cyclophosphamide therapy will be effective~     in resolving inflammation in patients with late phase antibody-mediated rejection refractory~     to current standard of care treatment.~   "
162269|NCT01441869|"~     Study in healthy subjects to measure amount of drug in blood after dosing with different~     saxagliptin / metformin products.~   "
147902|NCT01630525|"~     Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia. Subtle~     executive cognitive function deficits can be detected at this early pre-dementia phase, more~     than 10 years before dementia. Among them, the digit symbol substitution task (DSST) has been~     shown to be altered very early, up to 13 years before dementia. This test, as many others~     executive function tests, requires a fine control of visuomotor coordination. Like executive~     functions, eye movements, particularly voluntary-guided saccades, are under the control of~     the frontal lobe and fronto-parietal networks. Previous studies have shown a deterioration of~     voluntary saccades in AD using various paradigms. There are no data in prodromal AD, although~     the pathological process of the disease affects very early brain structures implicated in~     saccades execution (eg. caudate nucleus and pre-cuneus).~   "
147903|NCT01630512|"~     The purpose of this study is to determine whether mindfulness-based cognitive therapy~     (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in~     patients with diabetes.~   "
147904|NCT01630499|"~     Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest~     among women with a history of breast cancer (stages 1-3) who are also overweight or obese.~     The purpose of this study is to compare a tailored nutrition, physical activity, and~     behavioral weight management program for breast cancer survivors against a widely available~     commercial weight management program. We hypothesize that an intervention tailored to the~     unique psychological, nutritional and physical needs of breast cancer survivors will provide~     superior physiological and psychological benefits compared to an existing commercial program.~   "
147905|NCT01630486|"~     The goals of the KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney~     Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to~     10-year follow-up, and 2) to investigate the renal progression, mortality, complications,~     risk factors, role of biochemical parameters and the genetic influence.~      KNOW-CKD Research Group comprises nephrologists, pediatric nephrologists, epidemiologists and~     statisticians from eleven centers in Korea. KNOW-CKD will enroll 2,850 individuals with CKD~     stage from 1 to 5 between 2011 and 2015 and follow them up to 10 years. Dialyzed patients or~     those with allograft kidney are excluded. At enrollment and at pre-specified intervals,~     laboratory tests will be conducted on the kidney function, biochemical profiles, anemia,~     cardiovascular complication (echocardiography, coronary CT, arterial stiffness), and mineral~     bone disorder. A biobank is also established for the DNA, serum and urine at regular~     interval. Information on the medical history, health questionnaires, QoL will also be~     collected. Web-based case-report forms (CRF) is developed for the systemic management of the~     patient data.~   "
147906|NCT01630473|"~     Orthodontic therapy allows for the treatment of dental malpositions in order to produce an~     adequate relationship between teeth during occlusion. Conventional orthodontic therapy~     applies slight forces and moves teeth slowly. It is generally performed during a 2 year~     minimum of time. Recent studies seem to suggest that orthodontic therapy time can be~     shortened by surgical assistance (corticotomy). This investigation is aimed to determine the~     velocity of tooth movement and changes in periodontal clinical parameters between~     corticotomy-assisted orthodontic therapy and conventional orthodontic therapy.~   "
147907|NCT01630460|"~     CMD can be inherited in an autosomal dominant or recessive trait. CMD may also be caused by~     de novo mutations. The goal of this study is to identify genes and regulatory elements on~     chromosomes that are the cause for CMD. The investigators also study blood samples and tissue~     samples from patients to learn about the processes that lead to this disorder. The~     investigators long-term goal is to find mechanisms to slow down bone deposition in CMD~     patients.~   "
147908|NCT01630447|"~     The goal of this research study is to identify genes and regulatory elements on chromosomes~     that cause cherubism. Together with the investigators collaborators the investigators also~     study blood samples and tissue samples from patients to learn about the processes that lead~     to this disorder. The long-term goal of researchers involved in this study is to find~     mechanisms to slow down bone resorption in cherubism patients.~   "
147909|NCT01630434|"~     A prospective, international, multi-center, randomized controlled trial comparing~     preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush~     and storage (Control Group).~   "
147910|NCT01630421|"~     The goal of this research study is to identify genes and regulatory elements on chromosomes~     that cause ACC. The investigators also study tissue samples from patients to learn about the~     processes that lead to this disorder.~   "
147911|NCT01630408|"~     This is a pilot feasibility study to determine the effects of an activated vitamin D compound~     (paricalcitol) on heart structure (size) and function (ability to relax) in patients with~     normal kidney function and a form of heart failure known as HFPEF (heart failure and~     preserved ejection fraction). This study will also examine heart failure-related~     hospitalizations and changes in cardiac-stretch and biological markers that are believed to~     change along with heart size. Patients in this pilot study will be treated for a period of 48~     weeks with paricalcitol at a dose previously approved by FDA (1 mcg per day) and followed-up~     for 4 weeks after treatment is completed.~   "
147912|NCT01630395|"~     The purpose of this study is to determine if a recruitment maneuver combined with protective~     ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to~     one-lung ventilation during thoracic surgery.~   "
147913|NCT01630382|"~     The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal~     fluid congestion.~   "
147914|NCT01630369|"~     Primary Objective:~      - To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2~     Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)~      Secondary Objectives:~        -  To evaluate the percentage of patients with Hb A1c < 7.5%,~        -  To evaluate the rate of hypoglycaemia (symptomatic, severe)~        -  To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb,~          Insuman Rapid after 6 month treatment~        -  To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment~        -  To assess the overall safety~        -  To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers~          after second test compare to the testing of the initial level)~   "
148125|NCT01627613|"~     The purpose of this study is to assess the effect of orally inhaled AP301 on alveolar liquid~     clearance in ALI (acute lung injury) patients with the purpose to assess the treatment~     associated changes of extravascular lung water (EVLW) within 7 days of treatment.~   "
147915|NCT01630356|"~     This study was designed to test the hypothesis whether a novel intervention that uses~     motivational interviewing along with immediate feedback and follow-up counseling calls is~     effective in educating the household members about the health hazards of smoking and~     secondhand smoke exposure and reducing children exposure to secondhand smoke at households in~     Armenia.~      The study was a randomized control trial with two arms: intervention and control groups.~      The sample population for the study included households with a non-smoking mother and at~     least one child 2 to 6 years of age residing with at least one daily smoker. The study team~     recruited the households through pediatrician's offices in polyclinics (primary healthcare~     facilities) utilizing multistage random sampling. Trained interviewers made two baseline (one~     week apart) and two 4-month follow-up household visits to conduct measurements, interviews~     and intervention. Measurements included surveys, air nicotine monitoring in homes and hair~     samples from children to assess changes in nicotine concentration over time.~      SHS concentration was estimated by sampling vapor-phase nicotine using a filter badge treated~     with sodium bisulfate. Airborne nicotine monitors were used in all homes to measure SHS~     concentration at baseline and 4 month follow-up. At least one monitor was used in each home,~     preferably in the main room in which the family congregates.~      Personal exposure to SHS in 2-6 years old children was assessed using biological samples of~     hair. A small sample of hair (approximately 30 - 50 strands, 2-3 cm) was cut near the hair~     root from the back of the scalp where there is the most uniform growth pattern between~     individuals which minimizes the variability of the results.~      The intervention included an in-person counseling session with distribution of a tailored~     educational brochure and demonstration/feedback measurement of indoor PM2.5 (at second~     baseline visit); it also included one and two months follow-up counseling calls. The control~     group received only a brief educational leaflet on the hazards of second-hand smoke exposure.~   "
147916|NCT01630343|"~     The Null Hypothesis is that there is no association between Pain regime and the functional~     performance among geriatric patients having traumatic hip fracture. Two limbs are being~     assessed:1. Three weeks of regular oral Panadol and Tramadol after hip fracture 2. Oral~     Panadol and tramadol taking in p.r.n. basis. Functional outcome including Numerical Rate~     Scale for pain assessment, Functional Independency Measure and Elderly Mobility Score are~     chosen.~   "
147917|NCT01630330|"~     There are multiple important factors which need to be monitored when conducting ablation for~     atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is~     now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation~     patients.~   "
147918|NCT01630317|"~     Slow continuous ultrafiltration using central vs peripheral line: feasibility of~     implementation, safety and efficacy in acute heart failure syndromes.~   "
147919|NCT01630304|"~     The purpose of this study is to determine whether weekly text-messages improve retention in~     care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).~   "
147920|NCT01630291|"~     The purpose of this study is to investigate whether electrical stimulation of the nerve~     innervating the tear gland results in tear production in subjects with severe Dry Eye.~   "
147921|NCT01630278|"~     Very premature infants with a large ductus, selected by an early echocardiogram, will receive~     either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated~     echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional~     age. The primary outcome will be survival without cerebral palsy at years.~   "
147922|NCT01630265|"~     Previous studies demonstrate that patients often have difficulty understanding their~     discharge instructions. Video discharge instructions have the potential to mitigate factors~     such as illiteracy and limited physician time, which may affect comprehension. Our goal is to~     determine if adding video discharge instructions affects caregivers' understanding of their~     child's emergency department (ED) visit, plan and follow-up.~   "
147923|NCT01630252|"~     This is a prospective, three-part (Part A1, Part A2 and Part B),Phase II study investigating~     the efficacy, safety, pharmacokinetics and pharmacodynamics of the JNK inhibitor PGL5001~     orally administered for up to 5 months with concomitant DMPA administration for the treatment~     of laparoscopically diagnosed inflammatory endometriosis. The part A1 is open-label, the~     parts A2 and B are double-blind.~      The target population will be women of reproductive age and suffering from newly diagnosed~     peritoneal and/or ovarian endometriosis.~   "
147924|NCT01630239|"~     This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal~     Therapy (LITT) in the treatment of liver tumors.~   "
147925|NCT01630226|"~     This is a single center, non-randomized, open label phase II trial to evaluate the clinical~     and pathologic response of neoadjuvant cisplatin-monotherapy in BRCA1 positive patients. The~     study will enroll patients with diagnosed breast cancer with a BRCA1 mutation. Patients will~     be eligible if they have primary breast cancer (measured on mammogram and ultrasound or MRI)~     and confirmed histological diagnosis of invasive breast cancer by core biopsy. If axilla~     lymph nodes will be suspected then fine needle aspiration biopsy will be performed. Patients~     will be drawn from one of three oncology centers: Szczecin, Bielsko-Biała and Kraków.~      Patients will obtain staging investigations and will be monitored. Once entry criteria is met~     and consent obtained, all patients will obtain baseline staging investigation within 3 weeks~     of trial registration. Routine investigations will include staging scans: mammography,~     ultrasound of the breast and axilla (assessment of breast tumor and axilla lymph nodes),~     assessment of chest/abdomen/pelvis (plain film, Computed Tomography [CT] and/or ultrasound as~     per local standards) and baseline blood work (Complete Blood Count [CBC], electrolytes,~     creatinine, Liver Function Tests [LFTs], calcium, albumin).~      Once staging investigations are complete, all patients will be treated with cisplatin~     chemotherapy at a dose of 75mg/m2 every three weeks for a total of four cycles (4 cycles of~     neoadjuvant chemotherapy). Clinical response will be evaluated every three weeks by the~     treating physician while on chemotherapy (tumour of the breast and axilla lymph nodes). After~     four cycles of chemotherapy the patient will then undergo definitive surgery (mastectomy or~     breast-conserving surgery). Sentinel lymph nodes procedure will be performed. In case of~     positive lymph nodes standard lymph nodes surgery will be performed. Pathological complete~     response will defined as no evidence of residual tumor in the breast and the axilla. There~     may be evidence of ductal carcinoma in situ. The pathology will reviewed by two independent~     pathologists.~      Following surgery patients will receive standard adjuvant chemotherapy at the discretion of~     the treating physician and if indicated, the patient will also receive radiotherapy and/or~     hormonal therapy and/or adjuvant trastuzumab at the description of the treating physician.~   "
147926|NCT01630213|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study (VITAL-Echo) is being conducted among participants in VITAL~     and will examine whether vitamin D compared to placebo: (1) reduces left ventricular (LV)~     mass in elderly individuals as measured with 2-dimensional echocardiography and (2) improves~     LV systolic and diastolic function as measured with tissue Doppler echocardiography.~   "
147979|NCT01629511|"~     The goal of this clinical research study is to learn the highest tolerable dose of~     gemcitabine (out of 4 possible doses) that can be given in combination with busulfan and~     clofarabine before an allogeneic stem cell transplant. Researchers also want to learn if this~     combination can help to control CLL. The safety of this treatment will also be studied.~      Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer~     cells to die. It is commonly used in stem cell transplants.~      Clofarabine and gemcitabine are designed to block the growth of cancer cells, which may cause~     the cancer cells to die.~   "
147927|NCT01630200|"~     Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory~     process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and~     mortality in COPD. Early changes of vascular integrity can be detected via markers of~     subclinical atherosclerosis.~      Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option~     in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an~     anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data.~      The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor~     Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of~     systemic inflammation in the peripheral circulation of patients with stable chronic~     obstructive pulmonary disease.~   "
147928|NCT01630187|"~     The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg~     vs 100 mcg) in preventing uterine atony during elective cesarean section.~   "
147929|NCT01630174|"~     To evaluate the effect of concomitant late course accelerated hyperfractionation~     radiochemotherapy with pemetrexed and cisplatin in patients with esophagus cancer~   "
147930|NCT01630161|"~     The purpose of this study is to test different ways to help cancer patients maintain their~     smoking abstinence. Participants may receive educational materials as part of the study.~   "
147931|NCT01630148|"~     The use of prophylaxis for venous thromboembolism (VTE) remains grossly underused for women~     who undergo gynecologic surgery for benign conditions world wide and especially in developing~     countries including our region. Having a research in our locality for the first time might~     raise awareness of the importance of VTE prophylaxis.~   "
147932|NCT01630135|"~     Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in~     Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be~     evaluated compared with placebo.~   "
147933|NCT01630122|"~     The goal of this study is to demonstrate the feasibility of using a novel, validated panel of~     Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the A/S signature) as a~     diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies.~      Objectives:~        1. To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.~        2. To define a fixed statistical model of histologic subtype prediction in NSCLC.~      Study methods: To establish FNA biopsy requirements for gene expression-based subtype~     classification of NSCLC, patients with presumed newly diagnosed NSCLC, where radiographic~     studies and clinical description favor a probable diagnosis of NSCLC, will undergo FNA biopsy~     according to current standard techniques . For this part of the study, approximately 40~     biopsies of confirmed NSCLC will be collected for analysis.~      To define a fixed statistical model of histologic subtype prediction in NSCLC, we will~     prospectively collect 50 FNAs. These FNAs will represent Adenocarcinoma (AC) and Squamous~     Cell Carcinoma (SCC) cases at a ratio of approximately 1:1. Additional cases of not otherwise~     specified (NOS), should they be encountered, may also be collected for later analysis. FNA~     samples qualified based on cell number or ribonucleic acid (RNA) yield (depending on the~     findings of our primary objective)will be assayed on the QGS platform.~   "
147934|NCT01630109|"~     Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to~     either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior~     to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled design.~     The outcomes to be assessed are capsule study completion rates, gastric transit time, small~     bowel transit time, and the effect of diabetes on pill capsule completion rates. The purpose~     of the study is to assess if metoclopramide given prior to pill capsule endoscopy has any~     effect on pill capsule completion rate, gastric transit time, small bowel transit time, and~     pill capsule completion rates in diabetes.~   "
147935|NCT01630096|"~     Once the lab test is positive for c. diff, the investigators will order the patient to have~     PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not~     clear 2 more liters may be ordered. At enrollment, the treatment arm will have an order for~     500 cc Normal saline to be given I.V. The patient will continue with antibiotic treatment as~     well. The investigators will plan to check c. diff tests daily to see when they become~     negative. The investigators will perform chart audit/review to track mortality, the length of~     stay, ICU days, surgical intervention, and APACHE scores (assessment of disease severity).~     Chart audit will be used to collect data on their diet and how they feel using a visual~     analog scale (collected by nursing staff daily as a standard procedure; see attached pain~     scale). Using chart audit, the investigators will record whether the patient is~     immunocompromised or not.~   "
147936|NCT01630083|"~     The purpose of the trial is to assess the therapeutic effects and the safety profile of~     IMAB362 combined with EOX (epirubicin, oxaliplatin, capecitabine) as first-line treatment for~     patients with advanced adenocarcinoma of the stomach, the esophagus or the gastroesophageal~     junction compared to EOX alone.~      Furthermore, sufficient binding of IMAB362 to the target cells is necessary for antitumoral~     activity. Thus, two dose levels ensuring a serum level above the in vitro predicted clinical~     efficacy threshold will be investigated.~   "
147937|NCT01630070|"~     The objective of this clinical study is to evaluate the immediate and long-term (up to 12~     month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the~     treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot ulcers)~     due to the presence of arterial lesions in the below-the-knee arteries of maximally 50mm~     long.~   "
147938|NCT01630057|"~     An open-label, randomized, multi-centre, superiority study to assess that, in patients who~     respond to zonisamide added as third drug after failure of a two-drug combination therapy,~     the triple therapy is superior to the conversion to a double therapy including zonisamide.~   "
147939|NCT01630044|"~     This is a prospective, non-randomized and unblinded study designed to generate preliminary~     data to assess the effect of a new portable non-invasive brainstem stimulator to treat~     migraine headaches in patients with episodic migraine headaches.~   "
148023|NCT01628939|"~     The purpose of this study is to determine~        1. the prevalence of lumbar facet joint pain detected by manual segmental provocation tests~        2. the prevalence of MRI findings of the lumbar facet joints (hypertrophy, effusion, edema)~        3. the association of lumbar facet joint pain and MRI findings on a segmental level~      in subjects with current low back pain and in a control group.~   "
147940|NCT01630031|"~     Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial~     fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to~     PVs reconnection. In this setting, all procedural means able to improve the quality of tissue~     lesions are welcome.~      Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a~     new catheter available on the market, was a valuable additional tool increasing the efficacy~     of the ablation procedure for PVI.~      Methods - Prospective observational non-randomized monocentric study. Patients with~     paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter~     ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF~     ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH Catheter,~     Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF or EZ STEER~     THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60 consecutive~     patients are enrolled in the study, with 30 patients in each group. All procedures is~     performed by the same experienced operator, not blinded to the catheter used. Except for CF~     information (with an objective of at least 10 g, associated to the most perpendicular vector~     obtainable), ablation procedures are carried out using identical approaches in both groups.~     Patients are discharged from hospital free of antiarrhythmic therapy. Patients are enrolled~     in a specific follow-up plan.~      Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion of~     patients free of AF after 12-month follow-up.~   "
147941|NCT01630018|"~     The purpose of this study is to determine the efficacy and safety of belotecan or topotecan~     in patients with recurrent or refractory ovarian cancer (AOC).~   "
147942|NCT01630005|"~     Strokes are the first cause of acquired physical disability among adults. Some studies proved~     that depression is often an unrecognized complication from stroke, associated with a vital~     prognosis, functional and cognitive pejorative diagnosis. It led us to pose the hypothesis of~     the existence of a particular psychological state after stroke particularly favorable to a~     psychotherapeutic alliance. So, this longitudinal monocentric study aims to estimate the~     feasibility of a talk therapy and its impact on the anxio-depressive symptomatology after~     stroke.~   "
147943|NCT01629992|"~     The investigators examined whether a written plus verbal preoperative counseling for patients~     undergoing open cholecystectomy would improve perioperative symptoms such as nausea, vomiting~     and pain.~   "
147944|NCT01629979|"~     The effects of treatment of transplantation of harvested autologous epidermal cells on~     vitiligo lesions followed by narrow-band UVB will be investigated in a randomized controlled~     study.~   "
147945|NCT01629966|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone~     relative to placebo in the treatment of generalized anxiety disorder (GAD)~   "
147946|NCT01629953|"~     This study continues to develop and refine best practices in the delivery of vocational~     services to veterans with histories of felony convictions and mental health/substance abuse~     difficulties. There are currently over 225,000 incarcerated veterans and it is estimated~     64,000 veterans are released from prisons annually. These veterans encounter significant~     difficulties in finding employment due to stigma, intrapersonal difficulties, and out-dated~     work skills. Additionally these veterans are more likely to be homeless than other~     population., Previous work has found that manual based, vocational groups led by trained~     vocational staff led to quicker employment compared to traditional vocational services and~     manual based self studies. To attempt to improve on previous results, this study adds~     principles and components of supported employment including ongoing follow-up, treatment team~     coordination, and community based assistance.~   "
147947|NCT01629940|"~     The investigators propose to obtain facial photographs for use in testing a computer~     algorithm that recognizes males at high risk for Hypohidrotic Ectodermal Dysplasia (XLHED).~     FDNA (www.fdna.com), a software company with expertise in the area of facial recognition, is~     collaborating with the Sponsor in algorithm development based on 2D photographs not requiring~     special photographic technologies. A frontal facial photograph will be taken at the time of~     study conduct. The anonymized photographs will be transmitted to FDNA for analysis. A limited~     number of unaffected controls will be also be recruited.~      A subset of affected males between ages 5 and 25 years will have the option of having a blood~     draw for a set of laboratory studies assessing nutritional status.~   "
147948|NCT01629927|"~     The study proposes to enroll male subjects affected by Hypohidrotic Ectodermal Dysplasia~     (XLHED). The sweat duct images will be acquired with a CE marked skin-imaging device and the~     sweat rate will be measured using a CE marked pilocarpine iontophoresis and collection~     system. The technologies for both imaging of sweat ducts and the measurement of maximal sweat~     rate have been used safely and without adverse events in our prior studies involving~     HED/XLHED subjects. Furthermore, this study will assess the feasibility of developing a~     non-invasive screening tool that will enable detection of clinical signs of XLHED based on an~     analysis of a two dimensional frontal photograph.~   "
147949|NCT01629914|"~     The main purpose of this study is to evaluate changes in brain functioning using an MRI~     machine following mindfulness meditation training.~   "
147950|NCT01629901|"~     This is a prospective, non-randomized study designed to generate preliminary data to assess~     the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral~     blood flow on normal healthy volunteers.~   "
147951|NCT01629888|"~     The purpose of this study is to investigate the safety of consumption of three times the~     standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.~   "
147952|NCT01629875|"~     The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in~     moderate to severe glabellar line patients.~   "
147953|NCT01629862|"~     The investigators will examine the possible synergistic effects of obstructive sleep apnea~     (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part~     investigation:~        -  A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy~          controls.~        -  A three-month randomized placebo-controlled trial of continuous positive airway pressure~          (CPAP) in subjects with OSA+DM.~   "
147954|NCT01629849|"~     To investigate safety, tolerability, pharmacokinetics including posology, and~     pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic~     subjects~   "
164618|NCT01410994|"~     The purpose of the project is to study the relationship between post-bariatric surgery~     changes in weight and renal parameters.~   "
147957|NCT01629797|"~     Acne vulgaris is a chronic inflammatory disorder of the skin in the pilosebaceous unit of the~     hair follicle, associated with oil production. It is found across skin types and is present~     in 85% of adolescents, representing a large affected population. Because of the universal~     nature of the disease, 36.3% of acne patients come from backgrounds other than Caucasian.~      The purpose of this study is to examine patient knowledge about acne in different populations~     and to assess the effectiveness of a teaching intervention on acne knowledge. The~     investigators aim is to better understand and subsequently reduce any potential health~     disparities within the minority populations.~      This project will evaluate differences in acne knowledge between different ethnic groups, and~     the efficacy of an educational intervention. Subjects will first complete a survey evaluating~     their knowledge of acne and how acne affects them psychosocially before an educational~     intervention. Immediately following the intervention, the patient's knowledge of acne will be~     evaluated again. Finally, two months after the intervention, a phone call will be made~     evaluating their retention of the education materials and their quality of life related to~     psychosocial effects of acne. Investigating this educational intervention and any current~     disparities in acne education and understanding will better allow us to educate and treat~     acne patients in the future.~   "
147958|NCT01629784|"~     Studies have shown that there are significant differences in severity and outcome of lupus in~     patients of colored skin compared with Caucasians. There are many factors that lead to this~     discrepancy: genetics, poverty, education level, as well as behavioral and cultural factors.~     Cutaneous Lupus Erythematosus (CLE) is a disease of flares and remissions with identifiable~     triggers. One of the most aggravating triggers in CLE is sun exposure. The investigators~     hypothesize that there are disparities in knowledge about photoprotection, leading to poorer~     outcomes in minority ethnic groups. This study aims to assess knowledge of risk factors and~     triggers, especially sun exposure, and the effects on quality of life of Caucasian and~     minority populations, by conducting an assessment survey and subsequent teaching intervention~     on appropriate skin protection techniques including appropriate sun screen application, and~     use of sun-protective clothing. After three months a survey to evaluate knowledge retention~     about and the application of the educational intervention will be conducted.~   "
147959|NCT01629771|"~     According to the World Health Organization, lymphatic filariasis, a mosquito-borne parasitic~     disease, is the second leading cause of disability worldwide. Across 81 countries,~     approximately 120 million people are infected with the disease, and of those infected, an~     estimated 40% reside in India alone. The most disfiguring symptoms of lymphatic filariasis,~     elephantiasis and lymphedema, cause long-term suffering in patients who are then often~     embarrassed or even rejected from their communities. Because of the disease's debilitating~     physical and social effects on patients, this study will explore the intersection of~     disability and health-related quality of life (HRQoL) in lymphatic filariasis patients in~     India. Specifically, HRQoL and disability in lymphatic filariasis subjects and age- and~     gender- matched control subjects will be compared. Two HRQoL tools , the general Dermatology~     Life Quality Index (DLQI) and a disease-specific instrument developed by a dermatology group~     in India will be used to gauge HRQol. In addition, the demographic and disease-specific~     factors associated with HRQoL and disability in filarial lymphedema subjects will be~     identified.~   "
147960|NCT01629758|"~     The purpose of this study is to determine whether the combination of the 2 drugs being~     investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the~     clinical benefits of two different schedules of the combination.~   "
147961|NCT01629745|"~     RATIONALE: Testing for minimal residual disease in blood samples from patients with acute~     lymphoblastic leukemia may help doctors plan better treatment.~      PURPOSE: This research trial studies a genetic test in detecting minimal residual disease in~     samples from younger patients registered on COG-AALL08B1 trial.~   "
147962|NCT01629732|"~     The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir~     (DCV) when given in combination with or without Ribavirin~   "
147963|NCT01629719|"~     Phase III clinical study, two samples, with assessor blind for the purpose of evaluating the~     efficacy and safety of the superiority of the use of barium sulphate 66.7% w/v (Opti-bar) as~     a contrast X-ray (X-ray).~   "
147964|NCT01629706|"~     The purpose of the study is to investigate the corneal epithelial cell response associated~     with lens wear that results in solution-induced corneal staining (Phase1) and to determine~     the cell appearance in symptomatic and asymptomatic contact lens wearers (Phase 2).~   "
147965|NCT01629693|"~     The purpose of this study is to evaluate differences in the comfort at the end of the month~     between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft~     contact lens wearers.~   "
147966|NCT01629680|"~     A number of common eye diseases such as age-related macular degeneration and glaucoma are~     associated with ocular perfusion abnormalities. Although this is well recognized there is not~     much possibility to improve blood flow to the posterior pole of the eye in these diseases.~      For many years, moxaverine has been used in the therapy of perfusion abnormalities in the~     brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the~     drug, but also on the rheological properties of red blood cells. In two recent studies the~     investigators have shown that intravenous moxaverine increases choroidal and retrobulbar~     blood flow in healthy young subjects, in elderly people with healthy eyes and in patients~     with eye diseases associated with hypoperfusion. The present study aims to investigate,~     whether ocular blood flow is also improved after oral administration of moxaverine.~   "
147967|NCT01629667|"~     To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function~     in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic,~     progressive, irreversible, and usually fatal lung disease of unknown cause.~   "
147968|NCT01629654|"~     Fatigue is a common complaint after stroke, reported by 39-72% of patients. Poststroke~     fatigue is related to poor neurological recovery, low level of activities of daily living,~     decreased quality of life and may possibly affect the ability to return to work. Little is~     known about strategies addressing post-stroke fatigue and their effectiveness.~      Aim: to develop, test and evaluate a health promotion program based on strategies addressing~     poststroke fatigue.~   "
149862|NCT01604863|"~     The primary purpose of this study is to determine the maximally tolerated dose (MTD) of~     HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus~     carboplatin, cisplatin plus etoposide, or docetaxel.~   "
147969|NCT01629641|"~     The purpose of this study is to determine the test-retest and inter-rater reliability and~     concurrent validity of two iPhone goniometric applications in the measurement of active~     shoulder external rotation as compared to a standard manual goniometer. The scientific~     hypotheses for this study are as follows:~        1. There will be significant Pearson correlations (>.8) to demonstrate test-retest~          reliability for each of the tools between the 1st and 2nd round of testing as assessed~          by novice testers.~        2. There will be significant intra-class correlation coefficients (>.8) to demonstrate~          inter-rater reliability between the novice tester and the experienced tester for each of~          the three tools.~        3. There will be significant Pearson correlations (>.8) to demonstrate concurrent validity~          between the standard goniometer and the photo capture application, the standard~          goniometer and the accelerometer-based application and the photo capture application~          with the accelerometer-based app. as assessed by novice testers.~   "
147970|NCT01629628|"~     This study will be a prospective, open label, randomized, comparative study. Comparing the~     efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in~     maintaining remission of post-operative CD patients, with a high risk of disease recurrence.~      Patient assessment for efficacy will be conducted through interval endoscopic surveillance at~     24 and 52 weeks.~      Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be~     re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude~     therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks.~      The investigators expect a substantial increase in both endoscopic, as well as clinical~     remission rate in patients on adalimumab therapy.~   "
147971|NCT01629615|"~     The purpose of this study is to evaluate the clinical activity of BKM120 in patients with~     metastatic triple-negative breast cancer.~   "
147972|NCT01629602|"~     Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss~     of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a~     challenge problem. To resolve this problem, we combined the nerve branch with the boomerang~     flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. For~     comparison, we also collected a consecutive series of 32 patients with similar injury in the~     finger treated using a cross finger flap and a secondary free nerve graft.~   "
147973|NCT01629589|"~     The aim of this study is to describe immunogenicity of a single booster dose of Adacel~     vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.~      Primary objective:~        -  To describe seroprotection rates against tetanus and diphtheria in subjects randomized~          to receive either Adacel or Boostrix vaccine.~      Observational objectives:~        -  To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean~          antibody concentrations (GMCs) in subjects randomized to receive either Adacel or~          Boostrix vaccine.~        -  To describe booster response rates against tetanus, diphtheria, and pertussis in~          subjects randomized to receive either Adacel or Boostrix vaccine.~        -  To describe the rates of adverse events (AEs) immediately post-vaccination, and the~          rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with~          Adacel or Boostrix vaccine from Visit 1 through Visit 2.~   "
147974|NCT01629576|"~     Investigate whether economic incentives help obese individuals to lose weight.~   "
147975|NCT01629563|"~     This is a Phase III, multicentre, randomized, double-blind, parallel group, long-term study~     investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment~     of uterine myoma. The target population is composed of pre-menopausal women with symptomatic~     uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to~     assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg~     doses on uterine bleeding, myoma size, pain and quality of life.~   "
147976|NCT01629550|"~     Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them~     are avoidable and can be prevent by improving aseptic practices during catheter insertion and~     maintenance. Indeed, the main route of catheter contamination for short-term catheters is the~     insertion site. Consequently, the quality of skin disinfection is the most effective~     preventive measure to reduce the incidence of these infections.~      This aim of the present study is to compare four strategies of skin disinfection to determine~     whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone~     iodine in reducing catheter infection and to assess whether a detersion phase prior to~     disinfection reduces catheter colonization as compared with no detersion.~   "
147977|NCT01629537|"~     Post Traumatic Stress Disorder (PTSD), is a devastating condition which causes distress or~     impairment in social, occupational or other important aspects of functioning. The occurrence~     of PTSD in the military is on the rise. This has significantly impacted military members,~     their families, and society as a whole. According to an expert panel convened by the~     Institute of Medicine in 2007, the effectiveness of most currently employed PTSD therapies is~     low. Safe and effective treatments are urgently needed. The specific aim of this~     investigation is to evaluate the effectiveness of a novel approach to relieve PTSD symptoms,~     utilizing a procedure commonly used in pain management, a Stellate Ganglion Block (SGB) with~     local anesthesia. Male soldiers experiencing moderate to severe symptoms of PTSD will be~     recruited for evaluation of Stellate Ganglion Block with local anesthesia as an intervention~     for PTSD treatment. Participants will be randomized to receive either the SGB with local~     anesthesia to C6 tubercle or a sham procedure involving a subcutaneous saline injection to~     the neck. The PTSD symptoms before and after the procedure will be measured using a~     comprehensive clinician-administered scale, self-report measures, objective measures of~     cognitive ability, and physiologic reactivity measures. Subjects will undergo assessment~     prior to the procedure, one week following the procedure, one month and 3 months following~     the procedure. Patients receiving sham injections will be allowed to cross over to the~     treatment group. Based on published case reports of Lipov et al in Chicago and Mulvaney et al~     from Walter Reed Medical Center, who utilized this technique to successfully treat soldiers~     with combat-related PTSD, we predict that the use of Stellate Ganglion Block will result in~     reduction of PTSD symptoms as measured by clinician-administered scales, self-report~     measures, objective measures of cognitive ability, and physiologic reactivity measures,~     leading to a significant and lasting reduction of PTSD symptoms.~   "
147978|NCT01629524|"~     Hypothesis of this study is that increased immunity of primary tumor affects the increased~     number of lymph node retrieved. This study investigates whether immunity-related cytokine~     expression on primary tumor, colonic mucosa, and serum is associated with the number of lymph~     node retrieved in colorectal cancer patients.~   "
148024|NCT01628926|"~     -  To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in~          order to confirm clinical value of SPM 962.~        -  To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.~        -  To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.~   "
176777|NCT01251289|"~     A retrospective review of the prevalence of Group B Streptococcus Positive Pregnant Patients~     in an Inner City Tertiary Care Center~   "
147980|NCT01629498|"~     The goal of this clinical research study is to learn if the dose of radiation to the tumor~     but not the surrounding healthy tissue could be increased by using intensity-modulated photon~     therapy (IMRT) or intensity-modulated proton beam therapy (IMPT).~      In Phase I of the study, researchers want to find the highest tolerable dose of IMPT or IMRT~     that can be given to the tumor.~      In Phase II, researchers want to learn if IMPT can help to control the disease compared with~     standard proton therapy when both are combined with standard chemotherapy. Participants will~     also receive standard chemotherapy. Proton therapy and photon therapy are types of radiation~     therapy that are designed to use a beam of proton or photon particles (similar to getting an~     x-ray) to send radiation inside the body to the tumor.~      In IMPT and IMRT, the amount or strength of the protons or photons will be adjusted according~     to the size, shape, and thickness of the tumor. In this study, the tumor will receive a~     higher dose by adjusting the energy and scanning time of the protons or photons, which is~     called simultaneous integrated boost (SIB). The treatment will be done with image guidance.~     This newer type of radiation is designed to give a higher than standard dose of treatment to~     the tumor. It is also designed to focus the treatment on the tumor to avoid affecting the~     healthy tissue around the tumor as much as standard treatments.~   "
147981|NCT01629485|"~     The investigators will perform a randomized controlled trial with a stratified-block design~     to compare the effect of the part versus whole task simulation training for TEP repairs.~   "
147982|NCT01629472|"~     There is some evidence that suggests that economic empowerment and challenging gender~     inequalities and prevailing ideas on masculinities will lead to a decrease in levels of~     partner violence. However, there is still a gap in our understanding of what elements are~     required. This project evaluates whether participation within a savings group and a~     discussion group confronting gender norms will lead to an increase in women's individual~     agency and decision-making ability that will improve their economic independence and decrease~     intimate partner violence in their homes.~   "
147983|NCT01629459|"~     Barth syndrome (BTHS) is a disorder that is characterized by heart failure, exercise~     intolerance and skeletal muscle weakness. Preliminary evidence demonstrates that endurance~     exercise training does not significantly improve exercise tolerance in BTHS. Because~     endurance exercise training targets a metabolic pathway that is adversely affected by BTHS,~     the investigators hypothesized that resistance training may improve exercise tolerance in~     BTHS because this type of training targets a different metabolic pathway than does endurance~     exercise. Therefore, the overall objective of the pilot/feasibility/proof-of-concept proposal~     is to collect preliminary data on the following hypothesis: Supervised resistance exercise~     training (3x/wk, 45min, 12 wks) will improve exercise tolerance, heart function, muscle~     strength and quality of life, and will be found safe in adolescents and young adults with~     BTHS.~   "
147984|NCT01629446|"~     The purpose of this study is to see how lofexidine (investigational study formulation drug)~     is absorbed, broken down, and removed from the body. To do this, a special form of the study~     drug will be used that has a radioactive carbon atom attached. Blood, urine, and feces~     samples will be collected at different times to measure the amount of the study drug and~     radioactivity they contain. The amount of radioactivity you will be exposed to is less than~     the amount of radiation from a regular X-ray.~   "
147985|NCT01629433|"~     In the last years, botulinum toxin type A (onab/A) has been increasingly used as a treatment~     option for overactive bladder symptoms in patients affected by either neurogenic and~     idiopathic detrusor overactivity (DO). How onab/A injected into the detrusor muscle improves~     overactive bladder symptoms in neurologic patients has been only partially investigated.Some~     evidence suggested that the neurotoxin probably reduces detrusor muscle contraction blocking~     detrusor muscle cholinergic innervation. However, recent experimental observations indicated~     that onab/A determines more complex effects on bladder activity acting on afferent~     innervations as well as on the efferent one. Only few experimental studies have investigated~     the activity of onab/A on bladder afferent nervous transmission. Experimental studies in~     animals showed that Nerve Growth Factor (NGF) elicits increased sensation, urgency and DO.~     Although there are some evidence on the ability of onab/A to improve DO and to reduce bladder~     and urinary content of NGF, how onab/A influences NGF expression and the expression of TrKa,~     p75 and TRPV1 receptors is still unclear. The hypothesis is that onab/A reduces NGF bladder~     tissue levels and in the same time it modulates the gene expression of NGF associated~     receptors (TrkA, p75 and TRPV1).~   "
147986|NCT01629420|"~     The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with~     endometriosis.~   "
147987|NCT01629407|"~     This is an epidemiological, non-interventional, prospective study to collect data on glaucoma~     progression in a routine setting. Patients may receive treatment at the discretion of their~     physician per local standard of care.~   "
147988|NCT01629394|"~     Postoperative residual curarization in the post anaesthesia unit has been associated to~     complications involving respiratory function and impaired laryngeal and pharyngeal muscles'~     function. Speed of reversal of neuromuscular blockade after administration of sugammadex~     versus neostigmine has been studied, but up to date no data are available concerning~     continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii in~     morbidly obese patients undergoing weight loss surgery. The investigators' aim in this~     prospective, double-blinded study was to compare train of four ( TOF ) values, the presence~     or absence of clinical criteria of postoperative residual curarization , the dose~     requirements and the side effects of sugammadex and neostigmine for the reversal of~     rocuronium induced neuromuscular blockade in patients undergoing laparoscopic or open surgery~     for morbid obesity.~   "
148025|NCT01628913|"~     This was a multicenter, open label, randomized phase II study to evaluate the efficacy and~     safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate~     grade pancreatic neuroendocrine tumor (pNET).~   "
148055|NCT01628523|"~     Despite its life-saving potential, the mechanical ventilator has great potential to do harm.~     Despite years of research, the mortality in acute lung injury (ALI) remains very high.~     Treatment options after ALI onset are very limited, therefore prevention may be the best~     option. Unfortunately, the emergency department has not been studied with respect to~     mechanical ventilation practices, and its contribution to ALI is unknown. The investigators~     hypothesize that mechanical ventilation is frequently used in the ED and for a variety of~     reasons, and that ED mechanical ventilation has an effect on long term outcomes.~   "
147989|NCT01629381|"~     Study Objective: To assess the value of Rivaroxaban for the prevention of venous~     thromboembolism (VTE) after knee arthroscopy (KA) taking the placebo as standard of~     reference.~      Study Population: Patients undergoing therapeutic KA at the study Centers, irrespective of~     the type and duration of the procedure, will be eligible for the study.~      Study Design: Multicenter, randomized, double blind superiority, phase II trial comparing two~     arms:~        -  (R-7d) Rivaroxaban (10 mg od os) for 7 days~        -  (PL-7d) Placebo for 7 days.~      Follow-up: 3-month period after the randomization~      Standard of Reference:Placebo will be the standard of reference in accordance to~     international guidelines~      Study length May 2012-December 2012~      Total patients number: 500 patients~      Primary Efficacy End-Point: Occurrence in the 3-month period after the randomization of at~     least one of the following events, objectively proven (by means of CCDU; multi-slice chest~     TC-angio; autopsy, if necessary, or clinical ground):~        -  All-cause mortality~        -  Symptomatic VTE~        -  Asymptomatic proximal DVT~      Secondary Efficacy End-point:~      • Combined incidence of all DVT plus symptomatic PE~      Primary Safety End-point: Incidence of major bleedings.~      Secondary Safety End-point: Overall incidence of bleeding~   "
147990|NCT01629368|"~     This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on~     the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a~     single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a~     cross-over design. The anticipated time on study treatment is 40 days.~   "
147991|NCT01629355|"~     The purpose of this study is to study the predictive value of SensoDetect-BERA as a~     diagnostic tool in clinical practice for schizophrenia and bipolar disorder.~   "
147992|NCT01629342|"~     STANDARDIZED PHYSICAL ACTIVITIES MEASURED BY ACCELEROMETERS Background and aims: Physical~     activity may be assessed by several different methods. However, the use of accelerometers is~     the most direct method available for real-time measurements. The piezoelectric element of~     accelerometers records an electric voltage during movement which is then transcribed to~     Activity Counts (AC). Few studies have used Actical accelerometers to assess standardized~     physical activities and most of these were not applicable to patients in a hospital setting.~     No previous studies have applied Actical accelerometers to the wrists or ankles during~     standardized activities. The aim of this study is to record AC during different standardized~     activities frequently done by patients hospitalized for acute ischemic stroke.~      Methods: Patients discharged since February 2012 after a transient ischemic attack have been~     invited to participate in the study scheduled for June-September 2012 (nexpected=25). All~     participants wear 5 accelerometers (Actical), one at each wrist and ankle and one over the~     hip. Standardized physical activities include:~        -  treadmill walking (5 minutes, 1 and 4km/h)~        -  staircase walking (1 floor, normal pace)~        -  cycling with fixed load (5 minutes)~        -  standing up from sitting position and sitting down again (x5)~        -  standing up from supine position~        -  turning from left to right and back while lying in bed~        -  raising outstretched arm 90° (x5, standing position)~        -  eating (5 minutes, sitting position)~        -  drinking a glass of water~        -  sleeping (6 hours)~   "
147993|NCT01629329|"~     The objective of this randomized, double blind study is to demonstrate that one dose oral~     excedrin migraine (acetaminophen, aspirin and caffeine) is not inferior when compared to~     one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the~     emergency department.~   "
147994|NCT01629316|"~     Purpose: The purpose of this study is to determine if a comprehensive intervention supporting~     seek-test-and-treat results in a significant reduction in the potential for HIV-infected~     prisoners to transmit their virus after release from prison.~      Aim 2: Compare the effect of standard prison test-and-treat (sTNT) with the TNT-imPACT~     (imPACT) intervention on viral load 24 weeks following prison release.~      Aim 3: Describe and model secondary outcomes, comparing them between sTNT and TNT-imPACT~     study arms. These outcomes include post-release HIV transmission risk behaviors, incident~     STIs, adherence to ART, medical care appointments, emergence of ART resistance mutations, and~     predicted HIV transmission events.~   "
147995|NCT01629303|"~     Subjects with refractory chronic constipation are offered two conventional therapeutic~     strategies: either medical treatment, either surgery (in the case of medication failure).~     Nevertheless, a procedure less invasive than surgery could be an alternative strategy: the~     sacral nerve modulation. This procedure consists in stimulating the nerves which control the~     contractions of the colon and so the defecation phenomenon. Several open trials have~     suggested that sacral nerve modulation may be effective in reducing constipation and related~     symptoms. The aim of this randomized clinical trial is to assess the efficacy of the sacral~     nerve stimulation in patients with constipation.~   "
147996|NCT01629290|"~     This study will be a cross-over single blinded clinical study to evaluate the in vitro~     fluoride release of three different brands of 5% NaF varnish. The goal of this study is to~     determine if different formulations of varnish lead to differing amounts of fluoride release.~     Despite their similar concentrations of NaF (5%), some in vitro data have suggested that they~     may differ in the amount of fluoride release. Determining fluoride release of these varnishes~     in vivo is important in assessing both the safety and efficacy of the product.~   "
147997|NCT01629277|"~     The ultimate goal of the investigators ongoing research is the development of a closed-loop~     system for insulin delivery, which can help people with type 1 diabetes (T1D) attain a tight~     glucose control avoiding the risk of hypoglycaemia. The main components of the system are a~     continuous glucose monitor (CGM), an insulin pump and a computer-based 'model-predictive~     algorithm', which computes the amount of insulin to be given by the insulin pump according to~     the CGM values. In the studies performed thus far the efficacy and safety of closed-loop~     glucose control was evaluated both overnight and over a prolonged period of time including~     the day-time in children and adolescents with T1D. The results showed that closed-loop~     improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the~     conventional insulin pump therapy.~      The objective of the current study is to test the performance of closed-loop further, by~     evaluating the system during common non-compliant behaviours in the administration of meal~     insulin doses in adolescents with T1D. This will pave the way for a more comprehensive use of~     closed loop systems to control glucose levels in T1D under various real-life mimicking~     common circumstances. The present study adopts an open-label, randomised, 2 period cross-over~     design whereby closed-loop insulin therapy will be compared with the conventional insulin~     pump therapy in 12 adolescents with T1D.~      Participants aged 12 to 18 years will be randomised for two 24 hour studies in a clinical~     research facility, during which glucose levels will be controlled by either the~     computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump~     therapy (control arm). On both occasions, participants will under-estimate and omit the~     meal-related insulin dose for the evening-meal and lunch, respectively. The study will take~     place at the Wellcome Trust Clinical Research Facility (WTCRF), Cambridge with participants~     recruited from paediatric diabetes clinics in England.~   "
147998|NCT01629264|"~     The intraocular pressure in the human bulbus requires that the wall of the eye shows a~     certain (bio)mechanical strength. The human cornea represents the anterior portion of this~     wall. Since several years, there is a growing interest in the ophthalmological community for~     identifying factors modulating the biomechanical stability of the human cornea. Reasons are~     twofold: advances in keratoconus research and the increasing numbers of refractive laser~     surgery procedures with (correspondingly) increasing numbers of complications due to~     non-respecting the limits of corneal biomechanics.~      There is evidence that oestrogen, but also thyroïd hormone changes have a major impact on~     corneal biomechanics. A number of recent observational studies have reported on keratoconus~     and refractive laser surgery patients with decompensating biomechanics during pregnancy.~      Both hormones also show physiological changes during pregnancy and little is known about the~     impact of these physiological changes on the human cornea.~      The aim of this study is to establish baseline values for physiological changes in the human~     cornea during pregnancy.~   "
147999|NCT01629251|"~     The main focus of our research is the development of a closed-loop system for glucose control~     in people with type 1 diabetes. After having demonstrated the safety and efficacy of~     overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to the~     daytime. Meal-related insulin dosing can be challenging and prandial insulin overdosing can~     be associated with the occurrence of postprandial hypoglycaemia, thus representing a~     confounding factor of hypoglycaemia free glucose control during the day. A further~     investigation is needed to evaluate alternative strategies for prandial insulin dosing. We~     will study eight adolescents with type 1 diabetes during closed-loop insulin delivery~     combined with either standard or reduced insulin doses with the meals, in a randomised~     crossover design. Stable glucose isotopes will be administered to collect data for modelling~     of glucose turnover around the meals, during daily activities and overnight.~      The information provided by the use of glucose isotopes would be very helpful to increase our~     understanding of the physiology of glucose turnover and to facilitate the development of an~     improved control algorithm. Ultimately this study will help with the development of a~     closed-loop system to match insulin infusions to change in glucose levels in real life~     conditions.~   "
148000|NCT01629238|"~     The purpose of this study is to describe the cardiovascular risk profile in subjects who~     consume a marketed drinkable low fat fermented milk enriched with plant sterol.~     Investigations are lead prospectively and retrospectively among adults enrolled from general~     practitioners' database.~   "
148001|NCT01629225|"~     The purpose of this study is to investigate the association between GRK4 polymorphisms and~     essential hypertension in southwestern Han Chinese and test whether these polymorphisms were~     associated with the changes in blood pressure in patients with essential hypertension treated~     with angiotensin II Type antagonist candesartan.~   "
148002|NCT01629212|"~     The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and~     Octylonium bromide in the Treatment of Irritable Bowel Syndrome.~   "
148003|NCT01629199|"~     The purpose of this clinical trial is to evaluate the safety and efficacy of rhEGF~     (recombinant human Epidermal Growth Factor) in diabetic foot ulcer patients with uncontrolled~     diabetes mellitus.~   "
148004|NCT01629186|"~     The nasopharyngeal oxygen (NPO) with Nose-close (NC) and Abdomen-compression (AC) technique~     may use for support or rescue asphyxiated infants during Flexible bronchoscopy.~   "
148005|NCT01629173|"~     The aim of the study was to investigate the effectiveness of dynamic impression insoles on~     plantar pressure and pain reduction. A dynamic impression insole was made by sequential~     padding with Plastazote and P-cell under daily walking compression. The pain levels and~     plantar pressure with the use of dynamic impression insole were assessed and compared with~     7-mm Ethylene Vinyl Acetate (EVA) control, 9-mm uncompressed Plastazote and custom molded~     insoles. Plantar pressure was measured by a Pedar-X mobile system, and pain level was~     assessed using a Visual Analog Scales.~   "
148006|NCT01629160|"~     The purpose of this study is to evaluate feasibility of using new technologies to~     characterize ventricular wall motion in patients indicated for mapping and ablation~     procedures. Echo will be performed preoperatively and patients will receive a 1-month~     followup telephone call.~   "
148007|NCT01629147|"~     Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in~     children 4-10 years of age.~   "
148008|NCT01629134|"~     A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine~     in the lips.~   "
148009|NCT01629121|"~     The hypothesis was that the implementation of a Safe Kids East Central brain injury~     prevention program targeting children and caregivers admitted to the Georgia Health Sciences~     University Children's Medical Center is feasible and that short-term treatment effects of~     injury prevention education on the child or adolescent and the caregiver will increase~     bicycle helmet use.~   "
148010|NCT01629108|"~     Background:~      - Researchers at the National Institutes of Health give many tests of hearing and balance.~     These tests can help detect problems that affect hearing or balance. It is important to know~     exactly how healthy people perform on each of these tests. This information will indicate~     when a test result is normal and when a test result shows a problem. Researchers also want to~     determine the best methods for each test.~      Objectives:~      - To test different types of hearing and balance tests, and collect information on normal~     values for each test.~      Eligibility:~      - Healthy volunteers between 5 and 70 years of age.~      Design:~        -  This study will require a single visit to the National Institutes of Health Clinical~          Center. It will include both screening tests and study tests of hearing and balance.~          Sometimes, a second visit may be required if a test is designed to measure the same~          thing on 2 different days. Each visit will last between 2 and 5 hours, depending on the~          number of tests scheduled per visit.~        -  Participants will have a physical exam and medical history. They will also have basic~          tests to check for normal hearing and balance.~        -  Participants may have different hearing tests, including the following:~        -  Auditory Evoked Potentials to study how the ears and brain handle sound information.~        -  Auditory Processing Tests to study how a person processes complex sounds like speech in~          background noise.~        -  Tests of middle ear and inner ear function.~        -  Participants may have different balance and inner ear tests, including the following:~        -  Balance test on a tilting platform.~        -  Different tests to measure how well the eyes, ears, and brain work together to help~          maintain balance.~        -  Treatment will not be needed as part of this study.~   "
148052|NCT01628562|"~     It was hypothesized that the use of esmolol as an alternative to remifentanil with~     sevoflurane inhalation anesthesia during intracranial surgery, could provide better~     hemodynamic conditions and cause lesser side effects in the perioperative period. It was the~     main objective of this study to compare the effect of esmolol and remifentanil on the~     incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The~     comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes~     were the secondary objectives.~   "
148011|NCT01629095|"~     Background:~      - Non-alcoholic fatty liver disease is the most common form of liver disease in the United~     States. It includes many conditions. Researchers want to study fatty liver disease by looking~     at people who have liver cirrhosis. They also want to look at people who are or were listed~     for liver transplants. Genetic studies may provide more information on the causes of these~     conditions.~      Objectives:~      - To study possible genetic causes of non-alcoholic fatty liver disease.~      Eligibility:~      - Individuals of any age who have non-alcoholic fatty liver disease and related conditions.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will provide a blood sample for genetic testing. Liver tissue from a~          transplant or biopsy may also be studied.~        -  Participants may also be asked to have an imaging study of the liver. This imaging study~          may be an x-ray or magnetic resonance imaging.~        -  No treatment will be provided as part of this research study.~   "
148012|NCT01629082|"~     Background:~        -  Several types of blood cancer are associated with poor outcomes including high-risk~          myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute~          myelogenous leukemia (AML). Many people with MDS, CMML, and AML are not candidates for~          standard treatments. New types of treatment are needed for these cancers.~        -  Clofarabine and lenalidomide are anticancer drugs. The first damages cancer cells in the~          body. The second can alter blood supply to abnormal cells or affect how the immune~          system attacks these cells. These drugs have been previously tested as treatments for~          MDS and leukemia. However, they have not been tried as a combination for MDS, CMML, and~          AML. Researchers want to see if these drugs are safe and effective for these types of~          cancer.~      Objectives:~      - To test the safety and effectiveness of clofarabine and lenalidomide for people with~     high-risk MDS, CMML, and AML.~      Eligibility:~        -  Individuals at least 18 years of age who have high-risk MDS, CMML, and AML.~        -  Participants must not be candidates for standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and bone~          marrow samples will be collected.~        -  Participants will have 5 days of treatment with clofarabine. It will be given through a~          vein during an inpatient hospital stay. If there are no serious side effects after the~          infusion, participants will continue treatment as outpatients.~        -  After 28 days, participants will have a bone marrow biopsy to check their response to~          treatment.~        -  After the biopsy, participants will start lenalidomide treatment. Half of the~          participants will take the drug for 28 days (one treatment cycle). The other half will~          take it for 56 days (two cycles). More blood tests and biopsies will be used to monitor~          treatment.~        -  If there are no serious side effects and the disease does not become worse, participants~          may keep taking lenalidomide at lower doses for up to 12 more cycles.~   "
148013|NCT01629069|"~     The overall aim of this protocol is to examine patient and care-giver outcomes and acceptance~     of a new 6 week intervention in Arizona for our transplant and cancer patients and their~     care-givers, designed to improve quality of life, decrease perceived stress, and improve~     medical outcomes, that has been approved as a pilot clinical program at Mayo Clinic in~     Arizona.~   "
148014|NCT01629056|"~     This study aims to investigate the benefit of a new impedance-based computer software~     application during routine catheter ablation for atrial fibrillation, to see if this~     information improves short and long term electrical disconnection of the pulmonary veins.~     This study will be a single blind prospective randomised control trial in patients undergoing~     AF ablation. Study participants will be randomly assigned to undergo parts of their pulmonary~     vein ablation with, and parts of their ablation without tissue contact data displayed for the~     doctor performing the ablation to see. The pulmonary veins will then be studied at the end of~     the procedure, and at any repeat procedure in the future, to look for a difference in the~     recovery rate of the ablations performed using contact data, compared to those ablations~     performed without the use of this contact data. If a reduction in tissue recovery is achieved~     through the use of this tissue contact data, it may lead in the future to a reduced need for~     repeat ablation procedures, and better outcomes for patients.~      The investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the~     recovery of conduction, and promote long-term pulmonary vein isolation in patients undergoing~     left atrial ablation for atrial fibrillation.~   "
148015|NCT01629043|"~     In a recent study it was found that neurologist care for Parkinson's provides a 20% reduction~     in nursing home placement, hip fracture, and death (Willis 2011). However, as the authors~     recognized, the investigators don't know what it is about expert care that delivers this~     benefit. The National Parkinson Foundation's Quality Improvement Initiative was designed to~     identify the components of great care that yield great outcomes. By capturing demographics,~     clinical interventions and outcomes over time from multiple centers across the U.S, Canada~     and internationally, the best care practices from different clinics and different healthcare~     systems will be analyzed.~   "
148016|NCT01629030|"~     The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts~     as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.~   "
148017|NCT01629017|"~     This project allows for the systematic collection and analysis of long-term follow-up~     clinical parameters in children who have received a stem cell transplant. The data collected~     will assist in determining appropriate intervention and treatment plans for patients enrolled~     on this study. In addition, future patients may benefit by having the ability to anticipate~     problems and develop methods of prevention or early intervention.~   "
148018|NCT01629004|"~     The investigators hope to determine whether the addition of an FOBT kit and educational~     materials to a second mailed invitation compared to a second mailed invitation alone~     increases use of appropriate screening tests (FOBT for average risk or colonoscopy if~     increased risk) by eligible persons within 6 months of the second mailing in:~     (1)Non-responders to an initial mailed CRC screening invitation from their family physician~     and, (2)Those who responded to the initial mailed CRC screening invitation and are due for~     repeat screening (i.e., recall patients). In addition, the investigators will also explore~     the impact of the investigators intervention in likely under-screened groups such as those~     living in more remote areas of the province and those with low socio-economic status as well~     as assessing the cost-effectiveness of this strategy.~   "
148019|NCT01628991|"~     This study is a single blind randomized clinical trial to compare the efficacy of a~     behavioral intervention program versus vaginal cones on Stress Urinary Incontinence (SUI).~   "
148020|NCT01628978|"~     The investigators are trying to evaluate the efficacy of ultrasonographic determination of~     depth of endotracheal tube placement in infants and young children by using the pleural~     sliding sign.~   "
148021|NCT01628965|"~     Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease~     patients who are not concomitantly treated with L-dopa will be investigated with a doses.~   "
148022|NCT01628952|"~     This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric,~     phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of~     the abdominal wall during laparoscopic digestive surgery.~   "
148026|NCT01628900|"~     The prevalence of acute pyelonephritis (PNA) is 60-75 000/year. They are traditionally~     classified as uncomplicated (60-65%) and complicated. If it is assumed that the uncomplicated~     PNA can be treated as outpatients with a cure rate of over 80%, the second group is very~     heterogeneous. Some patients are severely infected. But others, despite an older age,~     structural urologic abnormalities or a controlled history, have no risk factors and can be~     simply managed. The investigators propose to reclassify the PNA into 3 categories:~     uncomplicated PNA (PNA-1), the PNA of moderate severity (PNA-2), the major PNA (PNA-3) to~     test whether the PNA-2 can benefit from the same outpatient care that the PNA-1. The~     existence of biological markers of the severity of bacterial infections would further support~     a tailored approach. The pro-adrenomedullin (pro-ADM), successfully tested to identify severe~     community acquired pneumonia, is a an interesting candidate.~   "
148027|NCT01628887|"~     This clinical trial studies a supportive education program for Latina breast cancer~     survivors. The Bilingual Breast Cancer Education Intervention (BBCEI) may help Latina breast~     cancer survivors know what to expect after completing breast cancer treatment and prepare~     them to cope with cancer related survivorship issues~   "
148028|NCT01628874|"~     The purpose of this study is to evaluate the effectiveness of a needle-free jet-injection~     system with 1% buffered lidocaine for local anesthesia for lumbar punctures compared to a~     topical anesthetic agent. Our hypothesis is: A needle-free jet-injection system (J-Tip) with~     1% lidocaine will provide local anesthesia that is comparable to that of a topical anesthetic~     agent (EMLA cream) when performing lumbar punctures in children.~   "
148029|NCT01628861|"~     The purpose of this study is to determine whether an on-screen prompt put on the work~     computer every 30 minutes is effective in getting office workers to reduce prolonged periods~     of sitting at work.~   "
148030|NCT01628848|"~     The primary objective of this study is to investigate efficacy and safety of SPM 962 in~     advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study~     following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg~     (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also~     to be investigated with distribution of the maintenance dose and accumulated response rate of~     efficacy.~   "
148031|NCT01628835|"~     The study is a randomized, single-blinded, controlled intervention trial to compare the~     effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for~     Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.~   "
148032|NCT01628822|"~     The main objective of this protocol is to measure the improvement of the overall situation of~     patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment~     relaxation.~      Secondarily,is to evaluate the evolution of physical variables, psychological and social~     improvement of the quality of life. To evaluate the evolution of drug consumption~   "
148033|NCT01628809|"~     The purpose of this study is to determine the effects of a three-day mindfulness meditation~     retreat (vs. a three-day relaxation retreat) in stressed, unemployed, community adults on~     brain function, brain structure, and overall health and immunity.~   "
148034|NCT01628796|"~     Is it possible to improve the accuracy of injection into the acromio-clavicular joint with~     the use of ultrasound?~   "
148035|NCT01628783|"~     In this study the investigators use clinical, biological and imaging markers to develop~     predictive markers for remission from depression. The investigators compare individuals who~     have received placebo to individuals who have received 10 mg of escitalopram for one week. In~     this double-blind, randomized study the investigators a) compare the groups to observe the~     short-term effects of escitalopram and b) study the predictive value of these observations~     with respect to remission. Measures include, but are not restricted to, limbic emotional~     reactivity as assessed by fMRI, emotional processing, emotional memory, autobiographical~     memory.~   "
148036|NCT01628770|"~     The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron~     preparation will be equally effective in correction of postpartum iron deficiency anemia.~   "
148037|NCT01628757|"~     Cervical cancer is one of the major health problems for chinese women. Besides surgery and~     radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many~     studies.~      However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic~     effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic~     burden, but also more importantly save time to take more suitable treatments.~      This study is undertaken to build a model combine both clinical and genetic factors to~     predict the effects of neoadjuvant chemotherapy.~   "
148038|NCT01628744|"~     In adult, the prevalence of mycobacterial infections is increased with age is largely~     unknown. IFN-gamma-IL-12/23 axis or NF-kappaB pathways might also plays crucial roles in~     adult against mycobacteria. Based on this hypothesis, the investigators had applied a~     functional assay to these pathways in patients with mycobacterial infection.~   "
148039|NCT01628731|"~     This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide~     continuous infusion in total urine output production during the first 24 post operative~     hours.~   "
148040|NCT01628718|"~     The primary objective of this randomized controlled non-inferiority trial is to determine~     whether or not Adaptive Disclosure (AD), a new combat-specific psychotherapy for Post~     Traumatic Stress Disorder (PTSD), is as least as effective as Cognitive Processing Therapy,~     cognitive only version (CPT-C), in terms of its impact on deployment-related psychological~     health problems (specifically PTSD and depression) and functioning.~   "
148053|NCT01628549|"~     To evaluate the safety and effectiveness of 3 strengths of P005672 compared to placebo for~     the treatment of moderate to severe facial acne.~   "
148054|NCT01628536|"~     The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will~     reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a~     pre-operative setting.~   "
148056|NCT01628510|"~     The purpose of this study is to investigate the developmental effects of two different types~     of positioning used with premature infants in the neonatal intensive care unit.~   "
148057|NCT01628497|"~     This study is looking at the difference in exhaled nitric oxide levels in patients with and~     without laboratory evidence of filariasis.~   "
177698|NCT01239108|"~     Dose escalation study for subjects with Leukemia that has returned or has not responded to~     standard treatment.~   "
148041|NCT01628705|"~     Background: Obesity is a chronic degenerative disease, considered as cardiovascular risk~     factor, characterized by systemic inflammation and high levels of oxLDL. Clinical studies~     have suggested that drink green tea could improve these complications.~      Objective: Analyze the effect of a moderate-fat diet complemented with green tea on oxLDL,~     fat mass and TNFa in obese women.~      Design: Randomized, controlled clinical trial. Obese women, without other~     chronic-degenerative disease were divided using a computer-generated random sequence: control~     group (CON) with n=32, and intervention group (INT) with n=32; and were instructed to consume~     a moderate-fat diet, and INT group was instructed to complement the diet with green tea.~     Anthropometric and biochemical measurements were performed, and oxLDL and TNFa s levels were~     determined by ELISA. All parameters were realized at baseline and in the 1st, 2nd and 3rd~     months post-intervention. TNFa mRNA expression was determined by real-time RT-PCR (basal and~     final). The changes on lipid profile, oxLDL, fat mass and TNFalpha expression were reported~     of the comparison between basal and final time points. The statistical analysis was performed~     with SPSS software.~   "
148042|NCT01628692|"~     The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir~     with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who~     are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.~   "
148043|NCT01628679|"~     Hypothesis:~        1. Specific physiotherapy interventions will decrease pain, improve pelvic floor motor~          control, increase self efficacy, improve sexual function and decrease pain~          catastrophizing behaviour in women with provoked vulvar vestibulodynia.~           This study will look at specific physiotherapy treatment interventions to see if they~          decrease pain, improve pelvic floor motor control, increase self efficacy, improve~          sexual function and decrease pain catastophizing behaviour. Participants will fill out a~          questionnaire on their pain symptoms and complete standardized scales prior to starting~          treatment and after 4 sessions to determine change due to interventions.~        2. A combination of physiotherapy, group educational sessions and group cognitive~          behavioural therapy will have better outcomes than physiotherapy alone.~      Results of physiotherapy intervention alone will be compared to results of those treated with~     physiotherapy, group educational sessions and group cognitive behavioural therapy at a~     separate treatment centre. Physiotherapy interventions and outcome measures are the same~     between both groups.~      Justification:~      Standard treatment is hard to identify as many approaches are taken, none with any evidence~     to support them. This study aims to look at specific techniques (pelvic floor coordination~     and relaxation exercises, education on female sexual response and pain pathophysiology~     education) to see if there is a benefit.~   "
148044|NCT01628666|"~     The goal of the study is to compare whether a center-wide policy of incremental antibiotic~     therapy will reduce CIED infection rate compared to a policy of conventional antibiotic~     prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics~     used are approved for use and readily available.~   "
148045|NCT01628653|"~     The purpose of this study is to examine feasibility and efficacy of the Ubiquitous Spaced~     Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly~     individuals with mild cognitive impairment (MCI).~   "
148046|NCT01628640|"~     This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis~     virus expressing interferon beta in treating patients with liver cancer or solid tumors with~     lesions that have spread to other parts of the body and do not respond to treatment. The~     study virus has a gene inserted into it which will allow production of interferon beta, which~     is a substance that will restrict the spread of the virus to tumor cells and not healthy~     cells. It will also have some independent anti-cancer activity. Although the primary goal of~     this study is to evaluate the safety of delivery of this viral agent to people, patients may~     benefit clinically by having shrinkage or stabilization of their tumor or reduction in their~     cancer related symptoms (e.g., pain). Funding Source - FDA OOPD.~   "
148047|NCT01628627|"~     Aim of this study is to evaluate safety and efficacy of transcutaneous frequency modulated~     electromagnetic neural stimulation (FREMS) to treat symptomatic peripheral neuropathy in~     patients with diabetes mellitus.~   "
148048|NCT01628614|"~     This is an observational study and will evaluate IOP reduction in newly diagnosed patients~     with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the~     discretion of the participating physicians according to their clinical judgment and the local~     standard of medical care.~   "
148049|NCT01628601|"~     This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG)~     or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are~     prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their~     physician.~   "
148050|NCT01628588|"~     This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice~     for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).~   "
148051|NCT01628575|"~     Periodontally accelerated orthodontics, also known as PAO, is a novel technique combining~     alveolar corticotomy and bone grafting prior to commencing orthodontic treatment. Using this~     technique orthodontic de-crowding and space closing, can be completed in 60-70% less active~     orthodontic treatment time. The addition of particulated bone graft following decortication~     allows for the widening of the bucco-lingual alveolar bony dimension, thus creating space for~     the movement of teeth, without the creation of dehiscences, usually a negative sequel of the~     standard orthodontic treatment.~      Aim: To evaluate the use of the PAO technique for the treatment of 20 adult patients 1 year~     post orthodontic treatment.~      Methods: 20 periodontally healthy adult patients requiring orthodontic treatment were~     admitted in the departments of Periodontics and Orthodontics in Hadassah Medical Center. All~     patients underwent full orthodontic and periodontal examination upon admission including a~     pretreatment CBCT scan. Decortication followed by grafting was made after the orthodontic~     appliances have been placed. The orthodontic appliances were activated immediately after~     surgery and every 2 weeks. During the 1 year follow up a periodontal and orthodontic clinical~     evaluation were made, as well as a CBCT scan.~   "
148070|NCT01628328|"~     This study aims to examine the hypothesis of tumor cell dissemination after colonic stenting~     for obstructing colorectal cancer by measuring the level of plasma circulating tumor cell~     before and after the procedure of successful colonic stenting in patients.~   "
148058|NCT01628484|"~     The objectives of this monocentric investigator initiated exploratory clinical trial is to~     optimize allergen delivery across the epidermal barrier. The cornified outer epidermal layers~     represent the main barrier towards entry into the viable epidermal layers. In the latter we~     aim to target the allergen for uptake by professional antigen presenting cells, called~     Langerhans cells. At the same time as little allergen as possible should be delivered to the~     dermis. The latter contains a high density of sensitized mast cells eliciting local reactions~     and also a high density of blood vessels which could lead to systemic distribution of~     allergen and therefore to systemic allergic reactions.~      In birch pollen allergic individuals we will compare different methods of preparing the skin~     before application of the allergen. We will subsequently apply titrated allergen doses to the~     prepared skin areas to determine at which dose we start observing mast cell degranulation~     manifesting as hives.~      This will allow for determination of the maximal tolerated allergen dose for each skin~     preparation method.~      The skin preparation methods compared will be:~        -  Single pricking with prick lancet (Entaco LTD., Redditch, Worcestershire, UK,~          distributed by Stallergenes®).~        -  Tape stripping with conventional adhesive Tape (Tesa-film®).~        -  Microchanneling with Micro Needle Patch (Micro Skin System, 3M®). The methods are~          strongly connected to routine diagnostics of allergies with low risk associated.~      The clinical trial protocol has been submitted to the local Ethics Committee.~      This comparison of skin preparation methods and the determination of the maximal tolerated~     allergen dose will help us to further improve epicutaneous allergen immunotherapy, which has~     the potential to make allergen specific immunotherapy not only considerably shorter and~     safer, but also more convenient for patients. Skin preparation by microneedle patches is~     significantly less painful than conventional injection and can be self administered. This~     should help improve the acceptance of allergen specific immunotherapy, as well as treatment~     compliance.~   "
148059|NCT01628471|"~     Lung cancer is one of the most prevalent and lethal neoplasias in the world. Currently used~     chemotherapy regimens have been disappointing in improving overall survival. Decitabine is a~     S-phase pyrimidine analog that induces DNA hypomethylation. This drug is currently used to~     treat Myelodysplastic Syndrome ( MDS) and has been studied for the treatment of leukemia.~     Genistein, is a soy extracted non-toxic isoflavone and phytoestrogen, which has been shown to~     inhibit activity of cell signaling pathways, such as those driven by tyrosine kinases.~     Results from in vitro experiments unambiguously demonstrated that the combination of these~     two compounds induces a synergistic reduction of the multiplication of lung, colon, breast~     and leukemic cancer cells. Consequently, clinical evaluation of this drug combination is~     warranted in Non Small Cell Lung Cancer ( NSCLC), and it is hypothezised that this new~     regimen will safely improve overall tumor response rate and cancer progression free survival.~      The proposed trial is a two part study: The phase I part is an open-label, dose-escalation~     evaluation in subjects with advanced solid tumors who have failed standard therapies and for~     whom no curative therapeutic option exists.~      A cohort of three subjects will be treated per dose level. One cycle is 28 days. Five~     different, increasing dose levels ranging from 60 mg/m2 to 500 mg/m2 of IV decitabine~     combined with a fixed oral dose of 150 mg BID of genistein will be tested. The Maximum~     Tolerated Dose (MTD) will be determined based on the occurrence of Dose Limiting Toxicities~     (DLTs).~      In the phase IIa part of the study, only Stage IIIb and IV advanced NSCLC patients will be~     treated at the recommended decitabine MTD dose combined with genistein. Safety and~     preliminary efficacy will be assessed. It is expected that a maximum sample of 46 patients~     will be enrolled in this trial.~   "
148060|NCT01628458|"~     The purpose of the study is to determine the safety of radiofrequency ablation of locally~     advanced pancreatic cancer that can not be surgically removed with the current standard~     procedures. Complications after the operation will be registered. Moreover a pain score will~     be determined, length of hospital stay, chemotherapy, survival, progression free survival and~     a tumour marker.~   "
148061|NCT01628445|"~     Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated~     with improved blood glucose control, weight loss and low rates of hypoglycemia when used~     alone or in combination with metformin. Liraglutide has not been extensively tested in people~     with type 2 diabetes who are taking relatively large doses of insulin (>50 U/day). Often~     these patients are insulin resistant and despite using large doses of insulin are not able to~     achieve glucose targets. The rationale for this study is to assess if the addition of~     liraglutide in addition to usual care versus placebo can improve blood glucose levels in~     people not achieving a target HbA1C of less than 7.0%.~   "
148062|NCT01628432|"~     The study compares the effect of bilateral salpingectomy associated with conservative~     hysterectomy on ovarian function to the standard hysterectomy with conservation of both~     ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications,~     quality of life.~   "
148063|NCT01628419|"~     The purpose of the current investigation is to examine the effects of health intervention~     program at the workplace on health risks for cardiovascular disease, well-being and~     absenteeism at the workplace.~      Participants: 1500 male and female employees from 10 different companies across Israel will~     take part in the study. Age: older than 18 yrs.~      Hypothesis 1: The intervention program will have positive effects on the health risks for~     cardiovascular disease. For example: Will be reflected in a decrease in LDL and increase in~     HDL.~      Hypothesis 2: The intervention program will have positive effects on the absenteeism at the~     workplace (e.g. decrease in days of sick leave per employee).~   "
148064|NCT01628406|"~     The investigators record all indications, treatments and outcomes from patients treated at~     the Neurosurgery Department.~        -  Trial with surgical intervention~   "
148065|NCT01628393|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     relapsing multiple sclerosis (RMS).~   "
148066|NCT01628380|"~     Aim of the Study is to compare two-years disease-free survival of Cytoreductive Surgery (CRS)~     and Hyperthermic IntraPEritoneal Chemotherapy (HIPEC, CDDP+Paclitaxel) vs CRS alone in Stage~     IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response after 3~     cycles of 1st line chemotherapy (CBDCA +Paclitaxel).~   "
148067|NCT01628367|"~     An important result of healing after tooth extraction is a reduction in dimensions of the~     remaining bone at that site. This reduction of bone volume precludes successful restoration~     of the space using a dental implant. Bone augmentation has shown promise in clinical reports~     to reduce this loss of bone volume, thus allowing implant placement and restoration. The~     purpose of this study is to evaluate the clinical and radiographic outcomes of guided bone~     regeneration around dental implants placed in fresh extraction sockets.~   "
148068|NCT01628354|"~     The investigators hypothesize that it is safe and effective to treat patients with choroidal~     neovascularisation (abnormal blood vessels growing under the retina) secondary to causes~     other than age related macular degeneration (AMD) and pigment epithelial detachments~     (blisters of fluid under the retina) secondary to AMD with ranibizumab (Lucentis).~      These groups of patients have to date been excluded from the multicentre trials demonstrating~     significant benefit of Ranibizumab in the treatment of AMD.~   "
148069|NCT01628341|"~     This non-interventional study is conducted in Europe. The study is both retrospective and~     prospective.~      The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in~     insulin-treated patients with type 1 and type 2 diabetes.~   "
148108|NCT01627834|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,~     crossover, oral bioequivalence study.~   "
148071|NCT01628315|"~     -  To examine short- and long-term value of appearance of new active lesions in predicting~          extent of cortical and subcortical deep gray matter (SDGM) atrophy over 5 years in ASA~          (Avonex- Steroid-Azathioprine)study.~        -  To explore how accumulation of cortical and SDGM atrophy over 5 years differs with~          respect to the number of new active lesions or amount of disease activity, in early~          relapsing-remitting multiple sclerosis (RRMS) patients who did or did not develop~          sustained disability progression.~        -  To examine the relationship between development of cortical and SDGM atrophy and~          regional likelihood of development of new active lesions over 5 years.~   "
148072|NCT01628302|"~     The present prospective, randomized, crossover study is designed to investigate the effect of~     salt consumption on blood pressure in hypertensive subjects.~      Secondary objectives of the study are to evaluate the effect of salt consumption on blood~     pressure among the subjects who are hypertensive and obese and normal according to body mass~     index and to evaluate the effect of salt consumption on renin activity in hypertensive~     subjects.~   "
148073|NCT01628289|"~     Introduction: There is no debate that people with diabetes should be screened for the~     development of retinopathy which can threaten their sight. However, there is no routine~     screening for retinopathy in Hong Kong at present. Many overseas countries find that they~     miss a large proportion of their target population and, with reliance on co-payments for~     screening, as is the case with the limited opportunistic screening at present, the~     cost-effectiveness of any routine service in Hong Kong could be reduced as is predicted by~     Hart's inverse care law.~      Aim: This study will determine the potential cost-effectiveness of screening for retinopathy~     in Hong Kong under a free system and one in which a co-payment is charged.~      Methods: Primary care patients attending General Outpatient Clinics on Hong Kong Island for~     their routine diabetic care will randomly be offered screening either at no charge or with~     the normal co-payment of $65. Those who are willing and unwilling to be screened will be~     compared for their clinical, lifestyle and socioeconomic characteristics and those unwilling~     will be asked their reasons. The uptake of screening at no fee and with a payment will be~     compared as will the prevalence of retinopathy in the two fee groups. Subsequent screening at~     one year will be offered at the same fee and uptake again compared.~      The principal analyses will (a) identify the characteristics of those willing to be screened~     and reasons for not being screened (b) the uptake of screening when a co-payment is charged~     compared to when it is free (c) whether there is a difference in the prevalence of~     retinopathy between the group willing to pay and those who accept free screening and (d) the~     uptake of re-screening in year 2.~      The resulting cost-effectiveness model will use these data, the cost data collected during~     the study and overseas data on benefits of treatment to model the cost-effectiveness of~     screening for retinopathy in Hong Kong if it were to be offered free or with a co-payment.~     This information will be important to determine the most cost-effective means of implementing~     this preventative strategy to preserve sight and quality of life.~   "
148074|NCT01628276|"~     This trial seeks to investigate brain network changes following cognitive rehabilitation in~     MS patients. The investigators hypothesize that rehabilitation interventions improve~     connectivity in the brain.Novel Magnetic Resonance Imaging technique is performed to~     investigate changes in brain plasticity.~   "
148075|NCT01628263|"~     The aim of our study is to determine the feasibility of carrying out a randomized controlled~     trial (RCT) to investigate whether screening parents of children admitted to pediatric~     intensive care unit (PICU) so as to target follow-up at those most at risk of developing~     posttraumatic stress disorder (PTSD), is effective at reducing adverse psychological~     sequelae.~   "
148076|NCT01628250|"~     Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery~     technique to perform a resection for colon cancer. Besides, the segment of the colon~     containing the tumor, the resection area should include an intact mesocolon as an envelope to~     encase the possible route for metastasis. The routes include blood vessels, lymphatic drain~     and etc. Such hypothesis predicts better histopathological and higher oncological results~     which turns into better survival rate and better quality of life.~   "
148077|NCT01628237|"~     Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe~     handicap for patients and represents a considerable expense for healthcare system.~     Neurostimulation has currently not been validated in the treatment of back pain because of~     technological limitations in implantable spinal cord stimulation (SCS). The lack of a~     validated technique for back pain relief has prompted the development of newer devices,~     including leads with increased number of contacts (up to 16) and various geometric~     arrangements, the objective of which is to cover a larger area while attempting to extend,~     steer, or focus the electric field of the stimulation within the spinal cord regions. This~     led companies to design a new generation of multicolumn surgical leads that allow the~     activation of longitudinal and transverse electric fields (multicolumn spinal cord~     stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.~      The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal~     and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using~     axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment of~     lumbar pain.~      A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and~     80 years old suffering from refractory neuropathic pain of radicular origin with associated~     back pain will be included. Patients will be divided into two groups. One group with MSCS~     during the 12 months after the new generation electrode implantation and one group with CSCS~     during 6 months and MSCS between 6 and 12 months after the new generation electrode~     implantation.~      The following parameters will be evaluated during this study: overall pain VAS, leg pain VAS,~     back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating scale,~     Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and costing~     in relation to surgery and patient management.~   "
148078|NCT01628224|"~     This study involves two tasks. The first involves observation of patient care during~     simulated aeroevacuation missions in order to gauge task saturation. The second involves~     review of records from actual evacuation flights in order to determine the effects of task~     saturation on patient care.~   "
148079|NCT01628211|"~     The purpose of this study is to evaluate whether a second-look laparoscopy, followed by~     peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in~     case of peritoneal carcinosis, improves the overall survival of patients who have had radical~     resection of mucinous colorectal cancer.~   "
148080|NCT01628198|"~     Despite the development of many drug therapies designed to treat high blood pressure~     (hypertension), it remains a considerable and poorly managed health, social and economic~     burden. For various reasons, including the high health care costs of treatment, there are~     estimates that up to 65% of patients with high blood pressure have untreated and/or~     uncontrolled blood pressure (BP).~      Aside from its effect on kidney function, chronic high blood pressure increases the risk for~     stroke, and heart disease. It is also thought to be involved in the formation of irregular~     heartbeats. This link between high blood pressure and heart health has been well described,~     as has their combined effect on the aging and the obesity-battling Western world.~      A recently published study (Symplicity HTN-2 trial) established the benefit of a new~     treatment procedure, catheter-based renal sympathetic denervation (RSDN) for hypertension, as~     having enormous potential for the treatment of patients with high blood pressure. This~     multi-center trial will attempt to confirm and expand on these promising data. Patients who~     enroll in the trial will be followed for 4 years.~   "
148123|NCT01627639|"~     The purpose of this study is to determine whether acetazolamide are effective to reduce the~     length of mechanical ventilation in decompensated Chronic Obstructive Pulmonary Disease~     (COPD) patients developing pure or mixed metabolic alkalosis.~   "
148081|NCT01628185|"~     Pain assessment using self-report scales (Visual Analogue Scale, Numerical Rating Scale), is~     recommended in the general population, however it is not always possible in patients with~     altered neurological status such as sedated patients or patients with delirium. Consequently,~     pain assessment is highly challenging in these ICU patients. This is a prospective~     observational study assessing 3 behavioral pain scales in the ICU.~      The hypothesis of this proposal is that one of the three ICU pain scales has a more important~     reliability than the others. Such a scale could be recommended to be used to measure pain~     intensity in ICU patients not able to communicate.~   "
148082|NCT01628172|"~     Despite the development of numerous drug therapies designed to treat hypertension, it remains~     a considerable and poorly managed health, social and economic burden. For various reasons,~     including the significant health care costs of treatment, there are estimates that up to 65%~     of hypertensive patients have untreated and/or uncontrolled blood pressure (BP).~      Aside from its impact on renal function, chronic hypertension significantly increases the~     risk for stroke, coronary artery disease, heart failure, and vascular disease. It is believed~     to be involved in the progression of cardiac arrhythmias. This link between hypertension and~     cardiovascular health has been well described; as has their combined effect on the aging and~     obesity-battling Western world.~      The recently published results of the Symplicity HTN-2 trial (Renal sympathetic denervation~     in patients with treatment resistant hypertension) establishing the therapeutic benefit of~     catheter-based renal sympathetic denervation for hypertension, have enormous potential for~     the management of a large and challenging patient population. The proposed, multicenter trial~     will attempt to confirm and expand on this promising data by conducting a double-blinded,~     placebo-controlled trial.~      Patients may qualify to participate in this research study if their doctor has determined~     that they have drug-resistant, chronic hypertension.~      Overall participation in this research study should be about 13 months which includes about 1~     month to start the study procedure and 12 months of follow-up after the study procedure.~   "
148083|NCT01628159|"~     The purpose of the study is to collect additional safety and efficacy information on the~     Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the~     femoral and popliteal arteries.~   "
148084|NCT01628146|"~     This phase IV study is an open, prospective, single-center, single-surgeon bilateral eye~     study to investigate the bilateral uncorrected intermediate visual acuity of presbyopic~     hyperopic patients, who have been treated with Presbyopia Algorithm SUPRACOR.~   "
148085|NCT01628133|"~     The purpose of the study is to determine whether packed red blood cell (PRBC) transfusion~     affects intestinal blood flow of premature infants during feedings and if so, whether return~     of normal intestinal blood flow pattern occurs within 48 hours of blood transfusion.~      Abnormal intestinal responses to the feedings (insufficient postprandial blood flow increase~     in order to digest given feeding volume or overall decrease of intestinal blood flow) may~     predispose infants to feeding intolerance and to serious intestinal disease called~     necrotizing enterocolitis (NEC).~      Patent ductus arteriosus (PDA) is a relatively common heart condition found in young preterm~     infants that can lead to decreased blood flow in different organs, including intestines.~     Thus, the determination of the presence or absence of PDA is an important part of the study,~     since it can be a relevant confounding variable.~      In this study, the investigators will assess intestinal blood flow by using sonogram to~     measure velocity through the superior mesenteric artery (SMA), the artery supplying most of~     the intestine, both pre- and 45 minutes post feeding. The investigators will also use~     echocardiogram to determine the presence or absence of PDA. Each set of measurements will be~     done immediately before and after the transfusion, and again 24 and 48 hours after the~     transfusion.~      Specific Hypothesis: The investigators hypothesize that infants will have attenuated~     postprandial blood flow velocities in immediate posttransfusion state when compared to the~     pretransfusion values. The investigators further hypothesize that normal, pretransfusion~     postprandial blood flow velocities will be achieved 48 hrs after the blood transfusion.~   "
148086|NCT01628120|"~     To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC~     administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in~     patients treated for anemia associated with chronic renal failure and on hemodialysis.~   "
148087|NCT01628107|"~     The purpose of the study is to determine the long-term safety in treatment-emergent adverse~     events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of~     target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal~     failure and on hemodialysis.~   "
148088|NCT01628094|"~     This randomized, open-label, multicenter study will evaluate the safety , efficacy and~     tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus~     (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In~     Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731,~     RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further~     treatment-naïve patients will receive a successful regimen from Part 1, or a reduced~     intensity regimen, and patients who have previously experienced null response to~     interferon-based treatment will be added to the study.~   "
148089|NCT01628081|"~     This is a double blind, parallel group, randomized study with 12 weeks of daily oral~     administration of Dunaliella or placebo in psoriasis patients.~   "
148090|NCT01628068|"~     Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of~     gastrointestinal bleeding. The investigators propose the percutaneous stop the oral~     anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in~     patients receiving anticoagulant therapy for atrial fibrillation without associated valvular~     heart disease, to reduce significantly the risk of stroke while minimizing the risk of~     bleeding in a group of patients with high risk for both events.~      ELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is~     a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of~     atrial appendage left versus standard treatment with oral anticoagulants in patients with~     history of gastrointestinal bleeding and high embolic risk.~   "
148124|NCT01627626|"~     The aim of this study is to evaluate the effect of 0.1% pilocarpine mouthwash on subjective~     dryness, minor salivary flow rates and unstimulated whole salivary flow rate in xerostomic~     patients.~   "
179012|NCT01221818|"~     The purpose of this study is to evaluate the safety and tolerability of single oral ascending~     doses of E6007 in healthy subjects.~   "
148091|NCT01628055|"~     The purpose of the study is to evaluate the ability of IVIG to affect the rate of progression~     of brain ischemia, as evidenced by neuroimaging.~      The results of an ongoing epidemiological study indicate that patients with primary~     immunodeficiency (PID) on IVIG replacement therapy have an overall prevalence of stroke that~     is 5 times less than in the general population. Even more striking is the absence of stroke~     in IVIG-treated PID patients over 65, while in the same general population age group the~     stroke prevalence goes up to 8.1%. This suggests that the degree of stroke protection~     correlates with the length of IVIG treatment, since older PID patients have been treated with~     IVIG significantly longer than younger ones.~   "
148092|NCT01628042|"~     This study will investigate the impact of impaired renal function on the plasma~     pharmacokinetics of vibegron (MK-4618) to guide use of vibegron in clinical trials in~     participants with overactive bladder and to guide recommendations on potential dosing~     adjustments for individuals with varying degrees of renal impairment.~   "
148093|NCT01628029|"~     The goal of this clinical research study is to learn about the effects of different~     combinations of melatonin, supportive counseling, light therapy, and methylphenidate/placebo~     in patients with cancer having sleep problems. The safety of these treatment combinations~     will also be studied.~      Methylphenidate is designed to increase the activity of the central nervous system.~      Melatonin is a hormone that is made by the brain and may help in letting your body know when~     it is time to go to sleep and when it is time to wake up.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     symptom, disease or illness. It is designed to be compared with a study drug to learn if the~     study drug has any real effect.~      Light therapy is designed to help people sleep better.~      Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression,~     pain, and/or sleep disorders.~      The use of the therapies to treat sleep disturbance in combination is experimental.~   "
148094|NCT01628016|"~     The purpose of this study is to test whether attention bias modification training is an~     effective neurobehavioral therapy to improve depressive symptoms.That is whether attention~     bias modification training is superior to placebo in reducing depressive symptoms over 1 year~     after training.~   "
148095|NCT01628003|"~     It is hypothesized that the long-term results of rehabilitation and subsequent aging after~     Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive,~     emotional) reserves.~      The purpose of this study are:~        1. to determine whether such reserves exist.~        2. to study their convergent and discriminant validity.~        3. to study their characteristics.~   "
148096|NCT01627990|"~     The purpose of this study is to observe the tolerability, safety and efficacy of preventative~     treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.~   "
148097|NCT01627977|"~     The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin~     and brilliant blue to stain the internal limiting membrane as well as the epiretinal~     membranes during the Vitrectomy surgery.~   "
148098|NCT01627964|"~     The study develops software for motion analysis and assessment of cardiac function for~     cardiac images. Cardiac catheterization ventriculography of several randomly selected~     patients were taken from our hospital's PACS system. The investigators remove the patient~     information on the images, and use the image for motion analysis and assessment.~   "
148099|NCT01627951|"~     An effective vaccine against malaria is urgently needed to combat the scourge of this~     disease. Before candidate vaccines can be tested in endemic countries, they are first tested~     in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a~     candidate vaccine should be tested against multiple strains of malaria, representative of the~     disease's global distribution. To date, however, only one such strain (NF54) has been broadly~     used in CHMI's.~      The purpose of this study is to compare the course of infections with 2 novel malaria strains~     to those with NF54 in human volunteers.~   "
148100|NCT01627938|"~     This study will primarily address the question whether the combination of Mitoxantrone~     therapy with dexrazoxane can reduce cardiotoxic side effects in the treatment of Multiple~     Sclerosis patients in comparison to Mitoxantrone monotherapy.~   "
148101|NCT01627925|"~     Upper airway obstruction (UAO) is a frequently occurring complication during induction of~     general anesthesia. The American Society of Anesthesiologist (ASA) closed claim analysis of~     anesthesia complications indicate that a difficult airway is one of the most challenging~     scenarios continuously facing anesthesia providers.~      The mechanism of UAO during anesthesia has not been well understood. Posterior displacement~     of soft palate, tongue and epiglottis are believed to be the primary contributing factors.~     Obesity is well known to be an essential characteristic which reflects propensity to UAO. The~     mechanism of UAO during anesthesia shares many similarities with the upper airway obstruction~     observed during obstructive sleep apnea (OSA). Nasal continuous positive airway pressure~     (nCPAP) via nasal mask (NM) can maintain the airway patent with near 100% success in patients~     with OSA. Obesity is a major risk factors for obstructive sleep apnea and obese patients have~     a higher prevalence of UAO during anesthesia. Therefore, the investigators hypotheses that~     nCPAP should eliminate airway obstruction in obese patients under anesthesia. The~     investigators propose to test this hypothesis and determine the efficacy of nCPAP on~     maintaining airway patency in obese patients who require general anesthesia.~   "
148102|NCT01627912|"~     The purpose of this study is to investigate whether red and white wine consumption has acute~     effects on postprandial biochemical markers related to platelet aggregation, inflammation and~     oxidative stress compared to water or 12.5% ethanol aqueous solution consumption.~   "
148103|NCT01627899|"~     Evaluation of the clinical benefits of One Touch VerioIQ system~   "
148104|NCT01627886|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,~     crossover, oral bioequivalence study.~   "
148105|NCT01627873|"~     The purpose of this study is to investigate the effects of two different analgesic methods~     (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status~     of patients.~   "
148106|NCT01627860|"~     The purpose of this study is to examine seizure control and tolerability of Topiramate after~     either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.~   "
148107|NCT01627847|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,~     crossover, oral bioequivalence study.~   "
148109|NCT01627821|"~     This investigation will be conducted as an interventional intention-to-treat clinical study~     in a population of end stage heart failure patients who meet specific inclusion and exclusion~     criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label)~     and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with~     Post-Auricular Connector to an active control group treated with the PMA approved Thoratec~     HeartMate® II LVAS for Destination Therapy.~   "
148110|NCT01627808|"~     The purpose of this study is to analyze hemodynamic changes, in patients undergoing liver~     resection, through the Vigileo/FloTrac system.~   "
148111|NCT01627795|"~     Malignant mesothelioma is a rare neoplasm that arises most commonly from the mesothelial~     surfaces of the pleural cavity, occasionally from the peritoneal surface, and rarely from the~     tunica vaginalis or pericardium. It has an extremely poor prognosis with a median survival of~     4 to 13 months for untreated patients 1 and 6 to 18 months for treated patients, regardless~     of the therapeutic approach.~      The anticancer activity of Oshadi D and Oshadi R treatment was tested in preclinical studies~     and in phase I clinical study. Four metastatic mesothelioma patients are treated for 5 to 12~     months. The Oshadi D and Oshadi R combination treatment was generally well-tolerated with no~     dose-limiting toxicities observed.~   "
148112|NCT01627782|"~     The purpose of this study is to explore the optimal dose frequency of ketamine in patients~     with treatment-resistant depression (TRD).~   "
148113|NCT01627769|"~     It is well documented that following thermal burns injury the development of hypertrophic~     scars and keloid (HSK) ranges between 40 to 90%. on the other hand It is well documented that~     cryosurgery wounds generally heal with minimal tissue contraction, resulting in good cosmetic~     results and with minimal complications.~      The Aim of the study is To specify the burn and cryosurgery blister fluid for proteins,~     cytokines and cells and To compare between the above data regarding possible proteins,~     cytokines and cells, in regard to their possible effect on scarring and wound healing.~      Also to Identify those components which are present only in the cryosurgery blister and which~     might have an anti-scarring effect and to characterize them biochemically.~   "
148114|NCT01627756|"~     Cardiopulmonary bypass (CPB) is well known to induce a strong anti-inflammatory response. The~     investigators examined whether continued mechanical ventilation during CPB alters systemic~     immune activation.~   "
148115|NCT01627743|"~     This is a multi-center, prospective, non-interventional study that aims to evaluate in daily~     clinical practice, the possible corelation between patIent perception of the ability to~     perform morning activities and physician evaluation; patients with COPD, grade C and D.~   "
148116|NCT01627730|"~     This research work develops a diagnostic and feedback-providing system for self-learning by~     volunteers who are asked to log in to a website to study the required subjects in three~     weeks.~      The system establishes students' learning weaknesses and offered guidelines for their~     improvement until all such weaknesses are corrected.~      Assessment is based on students' relative growth scores, and their record profiles.~   "
148117|NCT01627717|"~     Infection by both HIV and hepatitis C virus (HCV)is frequent due to similar transmission~     modes. Near 20% of people living with HIV are also infected by HCV. People living with HIV~     are treated by anti-HIV medications that may interact with numerous other medications,~     including new medications against HCV.~      Boceprevir is one of these new HCV medications and it is now considered as part of the~     standard of care for people infected with HCV. Previous research has shown boceprevir may~     influence the capacity of the liver to breakdown (metabolize) certain medications and when~     these medications are used in combination with boceprevir, their blood concentrations may be~     increased or decreased which could increase the risk of side effects or decrease efficacy.~     Among the drugs having a potential for an interaction with boceprevir is maraviroc, an~     anti-HIV medication. If concentrations of maraviroc increase, people may experience more side~     effects. However, if concentrations of maraviroc decrease, people living with HIV may have a~     lower suppression of the virus. This could increase the risk for the HIV virus to develop~     resistance, that is that the treatment will no longer be effective. No studies have been~     conducted to investigate the effects of boceprevir on blood concentrations of maraviroc. This~     research project addresses this research question. This project, however, cannot be done with~     people living with HIV since resistance may develop in these people if the concentrations of~     maraviroc decrease. It is for this reason that the investigators wish to recruit healthy~     people not infected with HIV nor HCV.~      Eleven healthy volunteers will be included. They will receive maraviroc 150 mg (1 tablet)~     every 12 hours from days 1 to 19 inclusively. On day 5, a total of ten blood samples will be~     drawn during the following 12 hours (at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours after~     maraviroc morning dose intake) to measure the blood concentrations of maraviroc. Boceprevir~     800 mg (4 capsules) every 8 hours with food will be started on day 6 and continued until day~     19 inclusively. On day 19, after the morning maraviroc and boceprevir dose, another ten blood~     samples will be drawn over a 12 hour period. A phone follow-up will be done on day 26. Thus,~     the total study duration for subjects is 26 days. The investigators will compare the blood~     concentrations of maraviroc when given alone to the blood concentrations of maraviroc when~     given with boceprevir.~   "
148118|NCT01627704|"~     Compare the response rate after 6 months of hormone treatment (or a major change in hormone~     treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions~     taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in~     patients with all metastases taking up FES prior to treatment.~   "
148119|NCT01627691|"~     The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve~     System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe~     calcific aortic stenosis who are considered high risk for surgical valve replacement.~   "
148120|NCT01627678|"~     Background:~      Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which~     control the HIV infection and results in increases in CD4 cell counts and an undetectable~     viral load, many patients suffer from increased morbidity. There is evidence that presence of~     antibodies against the C5 region of gp120 strongly correlates with slower disease~     progression, and that loss of antibody responses to this region are associated with~     progression.~      Investigational product:~      Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the~     C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a~     non-neutralizing antibody against C5 region.~      Study objectives:~        1. To evaluate safety of the vaccination regimens~        2. To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell~          activation markers and other immune markers.~   "
148121|NCT01627665|"~     The study will address the impact of genetical variation of a protein involved in the~     intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.~   "
148122|NCT01627652|"~     This scientific study aims at studying human adaptations to high altitude and the studies~     will be conducted at the University of Zürich and during a 4 week high altitude expedition~     to the Jungfraujoch research station at 3450 m altitude. The proposal is made up of several~     independent biological research projects to be conducted in the same healthy volunteers~     participating in the study. Thus, the subjects will be studied at sea level, and then during~     4 weeks of acclimatization to high altitude, and for some experimental purposes all subjects~     will also be studied one and two weeks after return to sea level.~   "
148126|NCT01627600|"~     The aim of the Atahualpa project is to evaluate the cardiovascular (CVH) status of the~     inhabitants of a rural village of coastal Ecuador as well as to determine the prevalence and~     retrospective incidence of stroke and ischemic heart disease. The protocol may be used as a~     pilot for large-scale studies attempting to evaluate the CVH of rural or even urban centers~     of Latin America, to implement cost-effective strategies directed to reduce the burden of~     stroke and cardiovascular diseases in the population at large.~   "
148127|NCT01627587|"~     This is a two part study. Part A of the study will evaluate the metabolites of GSK221149~     following single and repeat oral dosing and will also assess the pharmacokinetics of~     GSK221149 when administered with a potent CYP3A4 inhibitor Ketoconazole. Part B of the study~     will look at the pharmacokinetics of GSK221149 following a high fat meal.~   "
148128|NCT01627574|"~     The long-term objectives of this research are to develop effective treatments to reduce~     unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served~     at-risk youth population.~   "
148129|NCT01627561|"~     The current study will evaluate the immunogenicity and safety of Cervarix when administered~     according to a 2-dose schedule with or without co-administration of GSK Biologicals' MMR and~     DTPa vaccines in 4-6 years old female subjects as compared to the standard 3-dose schedule in~     15-25 years old female subjects, the population in which the clinical efficacy has been~     demonstrated.~   "
148130|NCT01627548|"~     A pilot intervention of an existing intervention adapted for the returning warfighter~     population: a couples treatment for PTSD, Structured Approach Therapy (SAT), which emphasizes~     reducing the PTSD avoidance/numbing symptoms that are corrosive in families.~   "
148131|NCT01627535|"~     This clinical trial studies optical imaging in assessing activity during surgery in patients~     with brain tumors. New procedures, such as optical spectroscopy, may help doctors maximally~     remove brain tumors and minimize damage to normal brain.~   "
148132|NCT01627522|"~     Preoperative use of finastride will decrease the amount of perioperative blood loss during~     and after TURP~      The effect of finastride on decreasing the amount of perioperative blood loss during and~     after TURP is dose dependent~      Finastride will decrease microvascular density in prostate tissue and this effect is dose~     dependent~   "
148133|NCT01627509|"~     Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways~     :~        -  as Basal/bolus therapy (B/B) in four-five injections per day .~        -  as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is~          achieved, the more likely patient would suffer from hypoglycemic episodes. We propose~          that the probability of hypoglycemia and its severity has no difference in two main~          insulin therapy schemes mentioned above.~      The objective of the study is to compare the incidence of hypoglycemia and its severity in~     well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens,~     through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style~     Navigator).~   "
148134|NCT01627496|"~     The aim of this study is to determine the nutritional status, and factors affecting~     malnutrition in older people staying in hospitals.~      Objectives:~        -  To recruit a sample of older people in hospital~        -  To collect information on nutritional status, satisfaction with food-related life and~          experience with access to food in hospital.~        -  To assess the staffing attitudes to nutritional care of the older adult~        -  To undertake an audit of therapeutic ('special') diets served in hospitals, with respect~          to their nutritional adequacy and wastage~        -  To investigate predictors and correlates of malnutrition within the hospital setting and~          compare these relationships with those previously identified in care homes and the~          community.~        -  To make recommendations for practice to improve the nutritional status of hospitalised~          older adults.~   "
148135|NCT01627483|"~     The aim of this study is to investigate if prescribing of fall-risk increasing and~     fracture-preventing drugs can be improved in older hip fracture patients by assessments of~     risks of falls and fractures and medication reviews performed by a physician and forwarded to~     prescribing physicians.~   "
148136|NCT01627470|"~     The aim of the study is to evaluate the accuracy of continuous non-invasive AP monitoring~     (CNAP) compared to simultaneous IBP measurement in intensive care patients undergoing a~     transport in the ambulance car.~      Since CNAP finger blood pressure is calibrated to NBP level, a systematic bias between IBP~     and CNAP as described by a recent FDA meta analysis [ ] is expected. The most important~     factor of CNAP system performance is its ability to accurately track blood pressure changes.~     Thus, the purpose of this investigation is to show that the bias between CNAP and IBP falls~     within the expected range and that blood pressure alterations are detected instantaneously.~      The endpoints of the study are:~        -  The agreement of systolic, diastolic and mean CNAP and IBP readings determined on a~          beat-to-beat basis during:~        -  Takeover of the patient on the intensive care unit,~        -  Transport of the patient from the intensive care unit to the ambulance car~        -  Transport of the patient in the ambulance car~        -  The agreement of systolic, diastolic and mean CNAP and IBP blood pres-sure changes~          determined on a beat-to-beat basis during:~        -  Takeover of the patient on the intensive care unit,~        -  Transport of the patient from the intensive care unit to the ambulance car~        -  Transport of the patient in the ambulance car~      The beat-to-beat readings of CNAP and IBP will be automatically recorded electronically on a~     memory card in the transport monitor. CNAP data will additionally be recorded directly on the~     CNAP Monitor with a memory stick. Safety will be assessed by clinical observations as well as~     adverse events (AE) recording.~   "
148147|NCT01627314|"~     This study is an open-label randomized, prospectively and historically controlled trial of~     the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant~     following myeloablative or reduced intensity conditioning for subjects age 15-65 years with~     hematologic malignancies. A maximum of 60 eligible subjects will be enrolled and treated in~     the trial at approximately 10 centers within the U.S.~   "
148235|NCT01626170|"~     This laboratory study is looking into mechanisms of radiation therapy resistance in samples~     from younger patients with rhabdomyosarcoma. Studying samples of tissue from patients with~     cancer in the laboratory may help doctors learn more about changes that occur in DNA and~     identify biomarkers related to cancer. It may also help doctors find better ways to treat~     cancer~   "
156791|NCT01513863|"~     The objective of this study is to demonstrate that metronidazole 1% topical gel is effective~     for the treatment of patients with moderate to severe rosacea.~   "
148137|NCT01627457|"~     In this Prestudy which will be followed by the multicentral GEx- main-trial, the feasibility~     of a new cardiac rehabilitation device (GEx system) is proved with coronary heart disease~     patients who participate in cardiac rehabilitation training exercise at the rehabilitation~     clinic (phase II) and subsequently at home (phase III). The GEx system consists of a~     easy-to-wear vest with integrated electrodes to measure electrocardiogram (ECG), respiration~     and activity, furthermore of a PDA to collect and store the monitored data and a cradle to~     charge the batteries. Several physiological parameters are extracted from thes measured vital~     signs like heart rate, breathing rate, ECG and activity. In this pretrial first the GEx~     sensor system is validated during guided exercise of the patients in the rehabilitation~     clinic (phase II). Subsequently at home (phase III) the practicability of the vest and~     sensors and possible technical problems in real- life use are proved. This means after~     moderate training like walking, cycling or running at home for 3 weeks patients will report~     the feasibility of usage. The ECG data and breathing- frequency data will be analyzed to see~     if data are recorded and transmitted well in regard to technical problems.~   "
148138|NCT01627444|"~     Does ear acupuncture reduce anxiety in mother of very low birth weight infants?~   "
148139|NCT01627431|"~     The peripheral arterial disease (PAD) is a common atherosclerotic disease manifestation and~     its prevalence increase with age and with the simultaneous presence of cardiovascular risk~     factors.~      PAD patients are usually treated, as a first line treatment, with the exercise therapy,~     combined with the pharmacological antiplatelet therapy.~      In the case of first line therapy failure, PAD patients usually undergoing to invasive~     revascularization procedures.~      After a peripheral stent has been located, the major follow-up problem is the restenosis~     rate.~      Published studies describe how, in a large amount of patients, can be recognised an high~     residual platelet activity. These data about PAD patients at the moment are lacking .~      The authors would evaluate the incidence of PAD patients with an high residual platelet~     activity.~   "
148140|NCT01627418|"~     Aim~      The purpose of this study is to evaluate whether fuel subsidies reduce exacerbations of COPD~     among people aged over 55, and therefore whether providing such subsidies is a~     cost-beneficial policy initiative.~      The Warm Homes for Elder New Zealanders Study enrolled community-dwelling people aged over 55~     with moderate or worse COPD. Prior to the study commencing the houses were insulated (if~     feasible, & the house-owner agreed). Data were collected on the health and energy use of the~     participants.~      The households randomly assigned to the early intervention group had a subsidy to their~     power account their first winter in the study. The subsidy was the intervention and was~     designed to enable the participants, if they chose to do so, to keep their house warmer~     during the winter.~   "
148141|NCT01627392|"~     The purpose of the study is to learn more about tobacco dependence and nicotine metabolism in~     African-Americans and whites, by studying to see if how fast a person metabolizes nicotine~     (how the body breaks down nicotine into inactive compounds) affects how dependent they are on~     smoking cigarettes. The investigators believe that people with a faster rate of metabolism~     may have more severe nicotine withdrawal symptoms and also may have a harder time trying to~     quit smoking.~   "
148142|NCT01627379|"~     More than 50% of patients with esophageal cancer have locally advanced or metastatic disease~     at presentation. The use of chemotherapy for this patient group is increasing with the~     intention of local and distant tumor control, improving quality of life and prolongation of~     survival.~      Previous data suggested not only that EGFR antibody targeted therapy may be safely combined~     with cisplatin and 5-FU but also may increase the efficacy of standard cisplatin / 5-FU~     regime.~      In the present study, patients with nonresectable, advanced or metastatic esophageal squamous~     cell cancer (ESCC) will receive chemotherapy or chemotherapy plus panitumumab every 3 weeks~     until disease progression occurs.~      The primary objective is to demonstrate superiority of 5-FU, Cisplatin and Panitumumab over~     5-FU and Cisplatin alone in terms of overall survival in esophageal cancer.~   "
148143|NCT01627366|"~     Improvements in early detection and successful treatment of breast cancer have lead to a~     steady rise in the number of breast cancer (BC) survivors. With so many individuals living~     for extended periods after diagnosis, the Institute of Medicine (IOM) recommends the~     implementation of treatment summaries and survivorship care plans (TSSPs) as a mechanism to~     improve ongoing clinical and coordination of care, and to address the immediate~     post-treatment and long-term effects of cancer treatment, including the ongoing psychosocial~     burden of a cancer diagnosis. The need for TSSPs has also been strongly advocated by the~     American Society of Clinical Oncology's Quality Oncology Practice Initiative and TSSPs have~     been included in the recently introduced Comprehensive Cancer Improvement Act (H.R. 1844).~     This will be one of the first randomized controlled trials to test the efficacy of TSSPs.~      The investigators will recruit 500 low income, medically underserved women from two county~     public hospitals, LAC+USC Medical Center and Harbor-UCLA Medical Center, 10-24 months after~     breast cancer diagnosis for participation in a randomized controlled trial (RCT) designed to~     test the efficacy of TSSPs. The investigators will randomize these women into one of two~     groups: 1) a control condition of usual medical care and 2) an experimental condition of the~     control condition + a tailored TSSP + 1 face-to-face nurse counseling session, with all~     cancer specialists and primary care physicians of record also receiving the TSSP and a cover~     letter suggesting how they can be clinically utilized.~      The investigators specific aims are to assess and compare between experimental and control~     groups the following primary outcomes at one year post-intervention: 1) discussion and~     implementation of recommended breast cancer survivorship care, including surveillance and the~     evaluation and management of BC treatment-related symptoms, 2) patient satisfaction with~     survivorship communication and care, 3) pertinent aspects of health-related quality of life,~     and further, to then 4) assess the cost-consequences of the experimental intervention. This~     study will provide a unique opportunity to assess the efficacy of TSSPs in a low-income,~     underserved population of BC survivors known to be at high risk for poorer long-term~     outcomes, including in mental health, quality of life, recurrence and mortality, and will~     therefore allow us to demonstrate the greatest possible benefit of such an intervention.~   "
148144|NCT01627353|"~     The study is a blinded randomized clinical trial, comparing policies of high volume~     preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no~     wound infiltration and routine anesthesia) for post operative pain management after~     hysterectomy. Morphine use and pain will be measured during index admission, and pain will~     also be measured six weeks postoperatively. The study will be conducted at a single site,~     Rockyview General Hospital.~   "
148145|NCT01627340|"~     This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine)~     when administered as a primary vaccination course at 0, 1 and 6 months in adults with or~     without type 2 diabetes mellitus.~   "
148146|NCT01627327|"~     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone~     Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide~     inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who~     have or are at risk for co-morbid cardiovascular disease~   "
148148|NCT01627301|"~     Patients with post-traumatic stress disorder (PTSD)and prehypertension (borderline high blood~     pressure) are at higher risk for developing high blood pressure and heart disease. The~     purpose of this study is to test whether PTSD patients have exaggerated increases in blood~     pressure, heart rate, and adrenaline levels during different forms of stress, that might~     predispose them to developing high blood pressure and heart disease. This study will also~     evaluate whether regular sessions of slow breathing that is guided by a device (RESPeRATE)~     improves blood pressure, heart rate, and adrenaline levels during stress in patients with~     PTSD and prehypertension.~   "
148149|NCT01627288|"~     The purpose of this study is to determine the maximum tolerated dose of integrated boost~     radiation therapy when given with concurrent chemotherapy (cisplatin).~   "
148150|NCT01627275|"~     Allogeneic stem cell transplantation offers the hope of cure for a wide variety of~     hematologic malignancies. Mature donor T-cells play a critical role in the success or failure~     of this procedure and a subset of donor T-cells mediate graft-versus-host disease while other~     subsets provide the foundation for immune recovery. The major challenge in allogeneic stem~     cell transplantation is determining how to maximally exploit the beneficial effects mediated~     by T-cells without causing GvHD. This challenge could be overcome by selectively depleting~     the population of donor T-cells responsible for eliciting the GvHD response. The study~     hypothesis is depletion of naïve T-cells from the donor lymphocyte inoculum will not cause~     GVHD while providing T-cells to affect both anti-infection and anti-tumor responses.~   "
148151|NCT01627262|"~     The purpose of this study is to determine whether mesalamine is effective in the treatment of~     uncomplicated diverticular disease by reducing the pain.~   "
148152|NCT01627249|"~     Although multiple studies have suggested that treatment with ranibizumab is safe and~     efficacious and superior to focal/grid laser alone for patients with center-involved diabetic~     macular edema (DME), there may be barriers in place to widespread adoption of ranibizumab use~     given its high cost per dose and the need for multiple treatments over time. Prioritizing~     resources from a public health policy perspective could be easier if more precise estimates~     regarding the risks and benefits of other anti-vascular endothelial growth factor (anti-VEGF)~     therapies were available, especially when the difference in costs could be billions of~     dollars over just a few years. Thus, there is a clear rationale at this time to explore~     potential anti-VEGF alternatives to ranibizumab that might prove to be as or more~     efficacious, might deliver equally lasting or longer-lasting treatment effects, and cost~     substantially less. Of the potentially available alternative anti-VEGF agents for this trial,~     bevacizumab and aflibercept are the best candidates for a direct comparison study.~     Bevacizumab shares the most similar molecular structure, costs far less, and is widely~     available. Furthermore, there is already preliminary evidence to suggest that it may be~     efficacious in the treatment of DME and it is already being widely used for this indication.~     Although aflibercept has a similar cost per unit dose to ranibizumab, it has the potential to~     decrease treatment burden and associated cost. If results from a comparative trial~     demonstrate improved efficacy or suggest similar efficacy of bevacizumab or aflibercept over~     ranibizumab, this information might give clinicians scientific rationale to substitute either~     one of these drugs for ranibizumab in the treatment of DME, and might thereby have~     substantial implications for public policy in terms of future estimates of health care~     dollars and possibly number of treatments necessary for anti-VEGF treatment of diabetic~     macular disease.~      Because of its availability and lower cost, bevacizumab is already currently in widespread~     clinical use for treatment of DME despite the lack of FDA approval for this indication. Thus,~     a clinical trial that suggested whether bevacizumab could be used as a safe and efficacious~     alternative to ranibizumab could substantially impact nationwide practice patterns for~     treatment of DME by either validating the current use of bevacizumab or by demonstrating~     improved outcomes with ranibizumab or aflibercept treatment for DME.~      Study Objective The primary objective of the proposed research is to compare the efficacy and~     safety of (1) intravitreal aflibercept, (2) intravitreal bevacizumab, and (3) intravitreal~     ranibizumab when given to treat central-involved DME in eyes with visual acuity of 20/32 to~     20/320.~   "
148153|NCT01627236|"~     The investigators will investigate the clinicopathological features of chronic hepatitis B~     patients with severe exacerbation selected by uniform criteria, and treated with early~     introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to~     clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic~     therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The~     investigators also observe the immune index in the change before and after the treatment, in~     order to searching for some prognostic index.~   "
148154|NCT01627223|"~     This is a prospective, observational, open-label, 2-arm, parallel, multi-center study.~     Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI (such~     as lamivudine and entecavir) is medically recommended will be screened for eligibility. To~     target 74 evaluable subjects, approximately 82 patients should be recruited into this trial.~     After enrollment, all eligible subjects will be randomly assigned to one of the antiviral~     treatments below.~        -  Cohort 1: Lamivudine 100 mg p.o. q.d.~        -  Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, <~          4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and~          the first dose of observational drug should be administered on Day 1. The observational~          period of individual subject will be 12 weeks; however, both treatments could be~          continued after the end of study based on physician's clinical judgment.~      The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29, 85, and 180~     days after initiation of antiviral treatment. All assessments should be conducted based on~     routine practice of each hospital. Only the analysis of HBV DNA and anti-HDV will be~     performed in the central lab. For patients who are willing to provide the residual samples of~     HBV DNA assessment, the blood samples will be preserved appropriately. All AE(s) and SAE will~     be followed until resolution or the event is considered stable.~   "
148155|NCT01627210|"~     This is a prospective, non-randomized, observational study conducted in the United States.Up~     to sixty (60) subjects will be enrolled. The purpose of the study is to evaluate long-term~     utility and usability of Dexcom G4 Continuous Glucose Monitoring (CGM) System. Subjects will~     be followed monthly over a period of one year.~   "
148156|NCT01627197|"~     Effect of adjuvant intra-arterial chemotherapy to control tumor progression in patients~     cystectomized for locally advanced bladder cancer.~   "
148157|NCT01627184|"~     The purpose of this study is to evaluate CGM glycemic control using the Dexcom G4 system as~     well as system performance during high levels of activity and home use by adult athletes with~     insulin-requiring diabetes mellitus, over an extended period of time.~   "
148204|NCT01626573|"~     This is a study evaluating a 28-day course followed by a 56-day course of INCB039110 in~     patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy~     parameters of INCB039110.~   "
148205|NCT01626560|"~     Primary: To determine the influence of daptomycin on inflammatory cytokine (IL-1, TNF and~     IL-6) for the treatment of complicated cellulitis/erysipela compared with alternative~     treatment (vancomycin or oxacillin). Secondary: To evaluate the clinical outcome of both~     groups according to levels of the cytokines evaluated.~   "
155796|NCT01526915|"~     The main objective of our study is to assess, after tooth extraction, the efficacity of PRF~     in the prevention of healing delay and of jawbone osteochemonecrosis induced by~     bisphosphonates~   "
148158|NCT01627171|"~     Colonoscopic examinations are performed routinely in hospitalized patients for a variety of~     indications. However, numerous limitations exist in hospitalized patients preventing an~     endoscopist from performing high quality examinations; possibly necessitating repeated~     procedures leading to increased cost and re-exposure to their inherent risks. One such~     prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown~     to be a predictor of poor bowel preparation as these patients are older, less mobile and have~     more co morbidities than the outpatient population. Currently, no standardized (or optimized)~     bowel preparation type or regimen for administration exists for the hospital inpatient~     population undergoing colonoscopy. Studies in the outpatient population have demonstrated~     that timing and choice of cathartic medication effects the cleanliness of the bowel~     preparation but there is no such clinical evidence for in-patients who receive whatever~     cathartic agent is on hospital formulary. The purpose of the study is compare efficacy,~     patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax)~     to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of~     dosages.~   "
148159|NCT01627158|"~     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with~     the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.~   "
148160|NCT01627145|"~     Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for~     Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With~     Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient~     Perception of Bladder Condition.~   "
148161|NCT01627132|"~     The purpose of this study is to assess whether dasatinib can be discontinued without~     occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in~     complete molecular remission (CMR) while on dasatinib.~   "
148162|NCT01627119|"~     For the past 50 years, gastric cancer has been one of the ten most frequent cancers and the~     second leading cause of cancer-related death in the world. In Taiwan, it is the fifth most~     common cause of cancer-related deaths, accounting for 6.3% of all cancer deaths. The poor~     prognosis of gastric cancer is mostly caused by the extensive metastasis to the lymph nodes,~     liver, and peritoneal dissemination even if curative resection was performed. The main cause~     of recurrence after curative or noncurative resection of advanced tumors is peritoneal~     metastasis because of possible direct spillage and dissemination of tumor cells as a result~     of surgical manipulation, and it is associated with a poor prognosis. As yet, no effective~     treatment has been developed for this condition. The development of peritoneal metastasis is~     a multistep process, beginning with attachment to peritoneal mesothelial cells, retraction of~     the mesothelial cells and exposure of the basement membrane, attachment to the basement~     membrane, degradation in the extracellular matrix, proliferation by the cancer cells, and~     angiogenesis, and it is clear that many types of agents are involved at the various stages of~     this process. Developing a new therapeutic method for this mode of metastasis is very~     important for improvement of gastric cancer treatment.~      CTGF is a secretory protein belonging to the CCN family (one among the three originally~     discovered members: cysteine-rich61, CTGF, and nephroblastoma-overexpressed gene). It is a~     multifunctional growth factor involved in wound healing, inflammation, cell adhesion,~     chemotaxis, apoptosis, tumor growth, and fibrosis. Recent studies showed that overexpression~     of CTGF in human oral squamous cell carcinoma reduces cell growth and tumorigenecity. Similar~     tumor growth inhibitory effects were observed in lung cancer cells in which CTGF~     overexpression was less angiogenic and metastatic due to blocking of the VEGF A signaling~     pathway. CTGF was also reported to be a key regulator of colorectal cancer invasion and~     metastasis, and it appears to be a better prognostic factor. These studies suggest that CTGF~     may involve the processes of peritoneal metastasis which includes cancer cell adhesion in~     peritoneum, proliferation and angiogenesis. Peritoneal mesothelium is the first surface~     encountered by disseminated tumor cells and successful adhesion is, therefore, of paramount~     importance in metastasis formation. Therefore, we hypothesized that CTGF is a potential~     molecule target, which may be related to cell adhesion to peritoneum, the first step of~     peritoneal metastasis, and its exact mechanism may includes proliferation and angiogenesis.~      In order to answer these important questions, first, we have performed the preliminary~     studies to prove CTGF did express in different gastric cancer cell lines including AGS, N87,~     TSGH, and MKN-45 by using RT-PCR and Western blotting, and gastric cancer tissues by using~     immunohistochemical method. Second, we demonstrated different levels of CTGF expression in~     different cell lines pose different adhesion ability in in-vitro adhesion assay. Third, we~     conducted a transient CTGF-overexpressed MKN45 gastric cancer cell line, and~     CTGF-overexpressed cell line had lower adhesive ability compared to the control.~      Next step in this project, we will be studying the roles of CTGF plays in cellular and~     molecular biology in vitro and in vivo and clinical significance associated with therapeutic~     potential of peritoneal metastasis from gastric cancer. We will generate stable clones of~     MKN45 cells harboring CTGF and its control cell line to elucidate the roles of CTGF in cancer~     cell adhesion, proliferation and angiogenesis in peritoneum.~   "
148163|NCT01627106|"~     This study will compare vernakalant therapy to amiodarone therapy in the acute management of~     recent onset atrial fibrillation.~   "
148164|NCT01627093|"~     The goal of this data review research study is to collect medical record information from~     patients with head and neck cancer that have received or are scheduled to receive proton~     therapy at MD Anderson. Researchers will study the medical record information to try and~     improve therapy for future patients with head and neck cancer.~      This is an investigational study.~      Up to 450 participants will take part in this study. All will be enrolled at MD Anderson.~   "
148165|NCT01627080|"~     The goal of this clinical research study is to learn if the radiation that you will receive~     for esophageal cancer may cause the heart to create more proteins called cardiac biomarkers.~      When cardiac biomarkers are above normal levels, there may be heart damage. The relationship~     between cardiac biomarkers and radiation therapy has not been well studied. Learning more~     about this relationship may lead to better ways to check the heart during radiation therapy~     and predict heart problems.~   "
148166|NCT01627067|"~     The goal of this clinical research study is to learn if exemestane and everolimus combined~     with metformin can help to control breast cancer in patients who are obese or overweight and~     post-menopausal with hormone-receptor-positive breast cancer that has spread to other parts~     of the body.~      Exemestane is designed to decrease the ability of estrogen to help cancer cells grow. This~     could cause the cancer cells to die.~      Metformin is commonly used to control blood sugar levels in patients with diabetes. It is~     designed to lower insulin levels, which may slow or stop the growth of breast cancer cells.~      Everolimus is designed to block cells from dividing. This may cause cancer cells to die.~     Everolimus may also stop the growth of new blood vessels that help tumors grow.~   "
148167|NCT01627054|"~     The purpose of this study is to find out what effects a new drug AT7519M has on chronic~     lymphocytic leukemia.~   "
148168|NCT01627041|"~     This randomized phase II trial studies how well decitabine works when given together with~     daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia.~     Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Decitabine may help daunorubicin hydrochloride and cytarabine~     kill more cancer cells by making them more sensitive to the drugs. It is not yet known~     whether low-dose decitabine is more effective than high-dose decitabine when giving together~     with daunorubicin hydrochloride and cytarabine in treating acute myeloid leukemia.~   "
148169|NCT01627028|"~     To investigate the skeletal effect of Thai traditional massage by examining the changes in~     biochemical markers of bone turnover.~   "
148170|NCT01627015|"~     In this study, the safety, acceptance and metabolic effects in infants receiving a novel low~     glycaemic index follow-on formula will be investigated.~      After 4 week intervention period, metabolic response after feeding is significantly different~     between a follow-on formula containing low glycaemic carbohydrate and a conventional~     follow-on formula containing higher glycaemic carbohydrates.~   "
148171|NCT01627002|"~     The purpose of this study is to examine the safety, tolerability, immunogenicity and the way~     the body absorbs, distributes, breaks down and excretes various increasing single and~     multiple subcutaneous doses of PA401 in healthy subjects.~      This study will also look at the effect of PA401 on inflammation in the lungs following an~     inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum~     induction (a procedure performed to help to cough up sputum (phlegm)) after a single~     subcutaneous dose of two dose levels.~   "
148172|NCT01626989|"~     Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining~     if the new device will treat those participants no worse than when compared to its~     predecessor device.~   "
148173|NCT01626976|"~     This is the first-in-human study for an oral investigational compound, PF-06282999, in order~     to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose~     levels.~   "
148206|NCT01626547|"~     The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients~     receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple~     myeloma and who are treated with Retacrit™.~   "
149240|NCT01613001|"~     To study the first hypothesis, a retrospective cohort analysis of Air Force members from~     January 2005 to December 2010 will be performed to evaluate the association of obesity as an~     independent predictor variable with musculoskeletal disease as the dependent variable.~   "
148174|NCT01626963|"~     Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal~     resections, due to it's short-term benefits over conventional open surgery. In recent years,~     several studies have demonstrated that - in suitable patients - single-port access surgery~     (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It~     remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL.~      In this study, the investigators aim to randomise patients who are deemed suitable for SPA~     surgery to either SPA approach, or CL; in addition to clinical outcomes including length of~     operating time, post-operative pain scores, complications, quality of life indicators and~     cosmetic appearance, the investigators aim to compare the physiological response to trauma~     through biochemical markers (including C-reactive protein, White Blood Cell count) and~     cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according to~     intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group. The~     patients will be operated by surgeons proficient in both CL and SPA surgery, and followed-up~     for the duration of their hospitalisation as well as at their routine out-patient visits,~     using questionnaires.~   "
148175|NCT01626950|"~     The main objective of this study is to estimate of the link (odds ratio) between the~     precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at~     diagnosis (2 groups: CAS: stages 1 or 2 the good prognosis versus the witnesses: stage 3 or~     4 bad prognosis).~   "
148176|NCT01626937|"~     Goal of the study: To show that prehospital NPPV use for COPD decompensation, as compared to~     only standard medical treatment, might enable a decrease in intubation rate.~      Primary end point: the rate of endotracheal intubation in the first three hours after~     randomization.~      Secondary en points: rate of endotracheal intubation after third hour, rate of prehospital~     and ICU mortality, ICU days, effects on clinical parameters (respiratory rate, SpO2, heart~     rate, arterial blood pressure, consciousness) and arterial blood gases (pH, PaCO2, PaO2), 30~     days mortality, delays between first medical contact and in-hospital admission, relation~     between initial pH level and endotracheal intubation.~      Inclusion criteria: Adult patients (>18 years), with GCS≥10, known or suspected COPD and~     presenting acute respiratory decompensation with respiratory acidosis.~      Exclusion criteria: Cardiac or respiratory arrest, upper gastro intestinal tract haemorrhage,~     shock, serious ventricular arrhythmia, severe sepsis, multiple organ failure, serious~     cranial-facial trauma, upper airways obstruction, undrained pneumothorax,~     uncooperative-agitated patients refusing the technique, respiratory distress with bradypnoea~     < 12/min, pauses gasps repeated bradycardia, intractable vomiting, acute traumatic~     tetraplegia, persistant hemodynamic instability with PAS<90mmHg, ensuitable environment.~      Randomization: Assignment to NPPV group or standard therapy group will be performed at the~     time of arrival of the SAMU team to the patient, by calling a physician located at the~     calldispatch center who will connect to the web site of the clinical research unit from~     Bordeaux university hospital.~      Period of study: 25 months (24 months for patients inclusion and 1 month for follow-up).~      Number of patients: 199 patients in each group i.e 398 patients (significance level of 5%,~     power of 80%; 50% expected decrease of intubation rate, i.e. from 20 to 10%).~      Main investigator: Dr Pierre-Arnaud Fort, MD, Pôle Urgences-SAMU47-Réanimation, Centre~     Hospitalier Saint-Esprit - Agen.~      Participating centers : 20 SAMU-SMUR corresponding to 19 departments in France.~   "
148177|NCT01626924|"~     In case of insufficient oxygen supply to the brain of a newborn child (perinatal asphyxia),~     toxic compounds will be formed. These toxic compounds will damage the cells of the brain. 2~     Iminobiotin (2 IB) is an investigational medicinal product that is related to vitamin B7.~     From studies in animals it has been shown that 2-IB may prevent the formation of the toxic~     compounds. Also it has been shown to be safe in in studies in juvenile animals and in~     healthy, adult male volunteers. The doctors hope that this will prevent (part of) the~     potential brain damage that may result from lack of oxygen to the brain.~      This study is the first study in the target population: newborn with moderate to severe~     oxygen shortage during birth. In this study the investigators evaluate short term efficacy,~     safety and pharmacokinetics of 2-Iminobiotin. In the follow-up phase the investigators~     evaluate the long term efficacy and safety.~      The study hypothesis is that 2-Iminobiotin will help to decrease the brain damage after~     oxygen shortage and is indeed safe. The brain damage will be measured both in the first week~     and during the first two years of life. The study was designed as a study with two parts an~     open label pilot part (6 patients) and a double-blind randomised part (60 patients). Due to~     lack of recruitment it was decided in September2014 to stop recruitment after the open label~     pilot part of the study (6 patients).~   "
148178|NCT01626911|"~     Our animal studies found that continuous regional arterial infusion (CRAI in the celiac~     trunk) of low molecular weight heparin (LMWH) could alleviate inflammation, improve global~     hemodynamics and restore organ function in a porcine model of severe acute pancreatitis~     (SAP,unpublished).~      In this study, the investigators aim to evaluate the effects of CRAI of LMWH in the treatment~     of SAP patients. The investigators suppose CRAI could help improve the outcomes of these~     patients.~   "
148179|NCT01626898|"~     Wake Forest University is partnering with Chatham Social Health Council (a community-based~     organization) to conduct a randomized controlled trial to evaluate the efficacy of Hombres~     Ofreciendo Liderazgo y Apoyo (HOLA) en Grupos (Men Giving Leadership and Support in Groups),~     a Spanish-language HIV risk behavior intervention for Latino men who have sex with men (MSM)~     in rural North Carolina.~      Participants in the HOLA intervention, when compared to those in the comparison intervention,~     will report: increased consistent use of condoms during sexual intercourse; increased use of~     HIV and sexually transmitted disease (STD) counseling, testing, and treatment services;~     greater knowledge concerning the impact of HIV on communities (including Latino and MSM)and~     HIV risk behaviors and prevention strategies; more positive attitudes towards abstinence and~     condom use; increased self-efficacy to use and assert the use of condoms with sex partners;~     increased condom-use mastery scores; decreased barriers to risk reduction (e.g.~     health-compromising aspects of machismo); and enhanced partner and provider communication and~     sexual negotiation skills.~   "
148180|NCT01626885|"~     The objective of this study is to evaluate the long-term safety, tolerability, and efficacy~     of MP-214 in patients with receiving multiple drugs schizophrenia.~   "
148181|NCT01626872|"~     The objective of this study is to evaluate the long-term safety, tolerability, and efficacy~     of MP-214 in patients with schizophrenia.~   "
148182|NCT01626859|"~     The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of~     MP-214 in patients with schizophrenia.~   "
148183|NCT01626846|"~     The study will seek to determine whether there is a corresponding deficit in school~     performance for teenagers with NF1. Secondly, the study seeks to explore the issue of~     self-esteem in teenagers with NF1.~   "
148220|NCT01626365|"~     The purpose of this study is to investigate the effect of double-lumen tube thermosoftening~     before intubation to reduce postoperative hoarseness and sore throat.~   "
148184|NCT01626833|"~     Anorexia nervosa may be responsible for a catch- down or even an interruption of growth,~     delayed puberty and osteopenia with failure of acquisition of bone mass. The recovery of~     normal nutrition usually leads to a resumption of growth and pubertal development. However,~     despite a therapeutic nutritional and psychotherapeutic satisfactory approach, some patients~     have a significant short stature with reduced adult final height and a deficit of bone mass.~     The main objective is to evaluate the effect of growth hormone (hGH) treatment on the growth~     velocity in prepubertal children or children in early puberty with anorexia nervosa and~     significant reduction of height velocity. This is a single-center, controlled, randomized and~     double-blind clinical trial evaluating the efficacy of hGH treatment for 1 year against a~     placebo, on the growth velocity of prepubertal or children in early puberty with Anorexia~     nervosa and major catch-down.This period is followed by the evaluation of the hGH treatment~     in children receiving placebo and continued hGH treatment in the treatment arm for 1 year, in~     total 2 years of study for each child. This second period corresponds to an ethical~     consideration giving secondarily access to treatment for patients in the placebo group.~   "
148185|NCT01626820|"~     This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition~     (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and~     safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.~   "
148186|NCT01626807|"~     Just two generations ago, walking or bicycling to school was the norm for a substantial~     number of US children, e.g. 48% of children walked or biked to school in 1969 versus only 13%~     in 2009. This decline occurred in the same timeframe as the childhood obesity epidemic, which~     is at record high levels in the US and affects low-income and ethnic minority children the~     most. This project will test the walking school bus (WSB) program, in which children walk~     to and from school with adults, and its impact on low-income, ethnic minority children's~     walking to school, physical activity, and risk for obesity. Ultimately, this line of research~     has the potential to provide a low-cost, easy to disseminate program to reduce risk of~     obesity and cancer for at-risk children.~      The investigators Specific Aims among 3rd-5th grade children include:~      SA1) To recruit 770 child-parent dyads from 22 elementary schools over 4 years and conduct a~     cluster randomized controlled trial to assess the efficacy of a WSB program on children's~     walking to school, physical activity, and BMI z-score over a school-year SA2) To collect and~     analyze data on individual-, school-, and macro-level influences on changes to children's~     walking to school resulting from the WSB program~      The Primary Hypotheses to be tested, in comparison to control children, include:~      H1) The WSB program will increase children's walking to school over a school-year.~      H1a) Parents' outcome expectations and self-efficacy will mediate the relationship between~     the WSB and changes to children's walking to school.~      H1b) Walkability, safety, and acculturation will moderate changes to children's walking to~     school.~      H2) The WSB program will increase children's physical activity and decrease BMI z-scores over~     a school-year.~      H3) The WSB program will increase school-level pedestrian safety behaviors over a~     school-year.~   "
148187|NCT01626794|"~     This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured~     with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The~     primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV)~     antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks~     after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response~     rate at 6 weeks after vaccination 1.~   "
148188|NCT01626781|"~     The purpose of this study is the examination of Mapisal® versus urea hand-foot cream as~     prophylaxis for capecitabine-induced hand-foot syndrome (HFS) in patients with~     gastrointestinal tumors or breast cancer, to assess the efficacy of Mapisal®.~      Mapisal® is a medical device that is approved for the prophylaxis and treatment of HFS.~     Initial clinical data and case studies on the treatment and prophylaxis of Caelyx-induced HFS~     have been impressive. Because the pathomechanism of HFS caused by capecitabine is the same as~     for Caelyx-induced HFS, it is expected reason that administering Mapisal® should result in a~     significant reduction of HFS caused by capecitabine. The urea hand-foot cream was selected~     for the standard arm, because it is used commonly, is accepted by patients, and seems to have~     a positive influence on the severity of the HFS in the experience of many oncologists.~   "
148189|NCT01626768|"~     The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study,~     multi-center clinical investigation.~      The purpose of this clinical investigation is to collect high quality medical images of the~     Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the~     study will allow for lead design and testing processes better tailored to the implanted~     environment.~   "
148190|NCT01626755|"~     Phantom limb pain following amputation is a major problem. Current evidence how to best~     prevent phantom limb pain is equivocal because previous trials have included small numbers of~     patients, and tested heterogeneous patient collectives. There is some evidence that optimized~     perioperative pain control is effective in preventing phantom limb pain, but the potential~     added role of regional anesthesia has not been defined.~      Objective:~      The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point~     prevalence of phantom limb pain 12 months after transtibial amputation for peripheral~     vascular disease compared to optimized intravenous pain therapy.~      Study design:~      Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All~     patients will receive standard optimized intravenous anesthesia and analgesia (opiate~     patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group~     will receive additional infusion of local anesthetic via a sciatic nerve catheter placed~     under ultrasound guidance.~      Main outcome of this study:~      Point prevalence of chronic phantom limb pain after 12 months.~   "
148191|NCT01626742|"~     Evaluate effects of an oral nutritional supplement on healthcare outcomes in older~     hospitalized adults. Also referred to as the NOURISH Study - Nutrition effect On Unplanned~     Readmissions and Survival in Hospitalized patients.~   "
148221|NCT01626352|"~     This is a single-arm, Phase II study designed to enroll and treat up to 64 patients. All~     patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6~     cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion~     bendamustine Days 1 and 2 of Cycles 1 through 6 and ofatumumab Days 1 and 8 during Cycle 1~     only and on Day 1 of Cycles 2 through 6.~   "
148222|NCT01626339|"~     Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will~     be recruited in this prospective self-controlled trial. Fundus photography will carried out~     at baseline immediately before injection and at 3, 7 days and 30 days after the first~     injection. Using image analysis software, measurements summarized as the central retinal~     artery equivalent (CRAE) and central retinal vein equivalent (CRVE).~      Null Hypothesis: There is no significant difference between arteriolar/venular diameter~     before and after injection of intravitreal ranibizumab/bevacizumab in the treated and~     untreated eye~   "
148192|NCT01626729|"~     The U.S. food and beverage industry recently released a new front-of-package nutrition~     labeling system called Facts Up Front that will be used on thousands of food products. The~     purpose of this study was to test consumer understanding of the Facts Up Front nutrition~     labeling system compared to the Multiple Traffic Light system (Traffic Light). Facts Up Front~     displays grams/milligrams and % daily value information for various nutrients; Traffic Light~     uses an interpretive color-coded scheme to alert consumers to low, medium or high levels of~     certain nutrients. Participants in an Internet-based study were randomized to one of five~     front-of-package label conditions: 1) No Label; 2) Traffic Light; 3) Traffic Light plus~     information about protein and fiber (Traffic Light+); 4) Facts Up Front; or 5) Facts Up Front~     plus information about nutrients to encourage (Facts Up Front+). Total percentage correct~     quiz scores were generated reflecting participants' ability to compare two foods on nutrient~     levels, based on their labels, and to estimate amounts of saturated fat, sugar, sodium, fiber~     and protein in foods. 703 adult participants recruited through an online database in May 2011~     participated in this Internet-based study and data were analyzed in June 2011. The~     investigators hypothesized that the Traffic Light label groups would perform better than the~     Facts Up Front groups on all outcomes.~   "
148193|NCT01626716|"~     Late-life depression is associated with physical limitations, greater functional impairment,~     increased utilization and cost of health care, and suicide. Collaborative care, linking~     primary and mental health specialty care, has been shown to be effective for the treatment of~     late-life depression in primary care settings in Western countries. The primary aim of this~     project is to implement a depression care management intervention, and examine its~     effectiveness on the depressive symptoms of older patients in Korean primary care settings.~     Based on chronic disease management theory and previous Collaborative care management studies~     in western countries, we propose to test a Depression Care Management intervention,which~     includes care manager to support a primary care physician of depression in their old~     patients. Care manager'd role are monitoring the progress of treatment, supporting patient's~     adherence, educating patients/ family and facilitate communication between providers. Also~     psychiatrists provide consultation and supervision of care managers. Using a randomized~     controlled design, we will examine whether the Depression care management is an effective~     treatment for patients with late life depression in rural Korea. The primary outcome would be~     the improvement of depressive symptoms of patients in primary care setting.~   "
148194|NCT01626703|"~     Depression affect between 5% and 10% of older adults seen in the primary care~     setting.Late-life depression is often chronic or recurrent and is associated with substantial~     suffering, functional impairment, and diminished health-related quality of life.Depressed,~     older primary care patients are frequent users of general medical services and may have poor~     adherence to medical treatments.They are also at increased risk of death from suicide and~     medical illnesses. The aim of this study is to examine whether depression screening and~     health care practitioner feedback are increased depression treatment rate.~      Depression screening is provided 60 or more who visited community health care center with a~     15-item Geriatric Depression Scale.GDS scores of 10 or more were classified depression~     positive. Intervention group participants received twice remind calls from primary care~     nurse.~   "
148195|NCT01626690|"~     The purpose of this study is to determine if placement of a forced-air warming device prior~     to institution of regional anesthesia improves perioperative temperature control in patients~     undergoing total hip arthroplasty.~   "
148196|NCT01626677|"~     This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®,~     human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or~     defects, compared with microfracture. Subjects who participated in and completed the Phase~     III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.~   "
148197|NCT01626664|"~     The purpose of this study is to estimate the overall response rate of subjects with relapsed~     or refractory Adult T-cell Leukemia-Lymphoma (ATL).~   "
148198|NCT01626651|"~     The purpose of this study is to assess the potential effects of ketoconazole on the~     pharmacokinetics of ibrutinib in healthy participants.~   "
148199|NCT01626638|"~     The primary objective is to validate the diagnostic correlation between the intraoperative~     microendoscopic images and the conventional histological analysis on biopsy and/or surgical~     specimens on patients with epidermoid carcinoma.~   "
148200|NCT01626625|"~     The investigators hypothesized that mesenchymal stem cells can be isolated from fracture~     site, iliac crest, and tibial crest, and can be expanded to be used in the management of~     nonunion fracture.~   "
148201|NCT01626612|"~     Rational: Severe sepsis is one of the leading cause of mortality in intensive care unit~     patients. Early initiation of an appropriate empirical antimicrobial therapy is associated~     with improved outcomes. In order to avoid an increase of selection pressure and the emergence~     of multidrug resistant pathogens, guidelines recommend to streamline the antimicrobial~     therapy after the identification of the pathogen responsible for infection. This strategy has~     been evaluated in several observational studies. However, at the bedside, few randomized~     clinical trials tested this strategy prospectively.~      Method: the investigators conduct a randomized clinical trial comparing a strategy based on~     de-escalation (streamlining of the empirical antimicrobial therapy) and a conservative~     strategy (continuation of the empirical antimicrobial therapy). The investigators first aim~     was to show that a strategy based on de-escalation is not inferior to a conservative strategy~     in terms of intensive care unit length of stay. Secondary aims are to compare the rate of~     mortality rate, the emergence of multidrug resistant pathogens, and the feasibility of~     de-escalation. The study is performed in nine intensive care units from four institutions,~     and 120 patients are required to validate the investigators hypothesis. New technologies for~     the rapid diagnosis of severe infections are investigated in an ancillary study.~   "
148202|NCT01626599|"~     This study is designed to collect data to support development of a novel product designed to~     sense changes in heart rate or movement during periods of sleep in people with epilepsy. When~     a potential seizure is detected, the system sends out an audio-visual notification.~   "
148203|NCT01626586|"~     In this research study the investigators want more about how being in a group about diabetes~     helps your family versus individual treatment. The investigators are asking youth with~     diabetes and their parents to be in the research, because the investigators want to see if~     this diabetes group and/or individual therapy is helpful to your coping, adjustment, and~     family communication about diabetes.~   "
148207|NCT01626534|"~     Ticagrelor is a new P2Y12 ADP receptor antagonist. This drug demonstrated a faster onset of~     action and a higher potency compared to clopidogrel standard regimen. Consistently these~     properties were associated in the PLATO trial, and particularly in the percutaneous coronary~     intervention (PCI) arm of the study, with a lower incidence of thrombotic complications at~     one year follow-up but at a price of increased major bleedings (7,8). The major finding of~     the trial was a significant reduction in one year mortality in patients treated with~     ticagrelor. This reduction in mortality may not be related to the anti-platelet effect of the~     drug since another potent anti-platelet agent which was recently commercialized a did not~     exhibit any improvement in death compared to clopidogrel. Therefore there may be non anti~     platelet directed properties, or pleiotropic effects, of ticagrelor that could be involved in~     a reduction in mortality in acute coronary syndrome (ACS) patients. In fact together with its~     anti platelet properties, ticagrelor, has been shown to inhibit the uptake of adenosine by~     red cells, leading to an increase in adenosine plasma level and then activating the low~     affinity adenosine receptor thus potentially affecting the vascular homeostasis including~     endothelial cells. Therefore, it is hypothesis that the side effects and its benefit on~     mortality may be related to its interaction with adenosine metabolism. In line with this~     hypothesis, some adverse effects of ticagrelor (bradycardia and modulation of~     bronchoconstriction) are compatible with the activation of low affinity A1 or A2A adenosine~     receptors.~      In addition the investigators have recently demonstrated that P2Y12 ADP blockade did impact~     the endothelial compartment during PCI (9). In fact the investigators have observed that the~     level of PR inhibition achieved by clopidogrel before PCI correlated with the extent of~     endothelial damage during PCI. More potent anti platelet drugs such as ticagrelor may thus be~     associated with reduced peri-procedural endothelial lesion which could further improve the~     clinical prognosis of patients. The investigators have previously observed that endothelial~     marker of lesion and regeneration could be measured in the blood post PCI (10).~      Finally, in the response trial no patients in the ticagrelor arm had HTPR compared to 50% in~     the clopidogrel arm (7). This finding is surprising since recent data suggest that some~     patients still exhibit HTPR following the use of the very potent third generation~     thienopyridine prasugrel. This may be related to the fact that in the response trial only~     stable patients were included.~      The investigators aimed to evaluate the anti-platelet efficacy and pleiotropic effects of~     ticagrelor in acute coronary syndromes patients undergoing percutaneous coronary~     intervention.~   "
148208|NCT01626521|"~     To access the clinical usefulness of F1+2 in the diagnosis of PE in patients with AECOPD who~     require hospitalization. Specifically, to determine whether F1+2 may have an additional value~     in the subgroup of patients with an abnormal D-dimer,to determine whether it may increase the~     proportion of patients in whom PE can be safely ruled out and to determine the sensitivity,~     specificity and NPV of F1+2 at various cut-off values.~   "
148209|NCT01626508|"~     The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated~     breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution~     of the total content and plasma profile of essential fatty acids (EFA) in a population of~     premature infants.~   "
148210|NCT01626495|"~     This is a study for children who have been previously treated for Leukemia/Lymphoma. In~     particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B~     cells (a type of white cell), which contain the cancer. This is a new approach for treatment~     of Leukemia/Lymphoma that involves B cells (tumor cells). This study will take the subject's~     white blood cells (T cells) and modify them in order to target the cancer.~      The subject's T cells will be modified in one or two different ways that will allow the cells~     to identify and kill the tumor cells (B cells). Both ways of modifying the cells tells the T~     cells to go to the B cells (tumor cells) and turn on and potentially kill the B cells~     (tumor cells). The modification is a genetic change to the T cells, or gene transfer, in~     order to allow the modified T cells to recognize your tumor cells but not other normal cells~     in the subject's body. These modified cells are called chimeric antigen receptor 19 (CART19)~     T-cells.~   "
148211|NCT01626482|"~     Muscle fatigue affects adversely the athletes´ performance and it is therefore one of the~     most investigated topics currently. However we do not know accurately the mechanisms that~     produce it.~      The aim of this study is to determine the influence of the Kinesio taping (KT) application in~     the paravertebral muscle fatigue in a sample of healthy young subjects.~   "
148212|NCT01626469|"~     The purpose of this study is to the determine the effect of salt intake and Captopril on the~     ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.~   "
148213|NCT01626456|"~     This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS~     9070) during long-term treatment of subjects with stable schizophrenia.~   "
148214|NCT01626443|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of~     reproductive age and is characterized by menstrual abnormalities, clinical or biochemical~     hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often~     suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of~     developing several metabolic disorders. Inositol is a six-carbon polyol which has been~     characterized as an insulin sensitizer: it exists as nine different isomers and among them~     myo-inositol and D-chiroinositol are the most represented and studied in physiology and~     physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans~     administration has been reported to exert beneficial effects at metabolic, hormonal and~     ovarian levels.~      The aim of this randomized study is to evaluate the metabolic and ovaric effects of a~     six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and~     hyperinsulemia.~   "
148215|NCT01626430|"~     Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF)~     on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at~     risk for metabolic syndrome.~      Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and~     postprandial lipemia in individuals at risk for metabolic syndrome.~   "
148216|NCT01626417|"~     The objective of this clinical study is to examine the acute kinematics and kinetics of~     utilizing the Tibion Bionic Leg in a sample of chronic post-stroke patients performing~     sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings~     (internal to the device); to compare these metrics to baseline performance without the Bionic~     Leg; and to determine the Bionic Leg settings that optimize a restorative (equal force~     distribution) movement state in these patients.~   "
148217|NCT01626404|"~     Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients~     are underserved. The purpose of this prospective, observational study is to obtain~     multi-center data on the proportion of patients with CRT and/or ICD who are candidates for~     advanced heart failure treatment and obtain insights into patient and physician decisions~     regarding referral for advanced heart failure therapy.~   "
148218|NCT01626391|"~     The primary purpose of this study is to assess the safety and tolerability of TRx0237 when~     taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or~     rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.~   "
148219|NCT01626378|"~     The purpose of this study is to demonstrate the safety and efficacy of TRx0237 in the~     treatment of patients with behavioral variant frontotemporal dementia (bvFTD).~   "
148223|NCT01626326|"~     This is an initial pilot study to determine whether people will use a research version of an~     iPhone Stop Smoking app. The investigators primary measures will consist of rates of~     recruitment (that is, number of people installing the app), use of the app, and completion of~     follow-up surveys regarding self-reported smoking status. The investigators secondary measure~     will be obtained quit rates and number of cigarettes smoked before and after using the app.~      To enter the study, participants must download the app from iTunes at:~      https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8~   "
148224|NCT01626313|"~     The study will examine the effectiveness of an eight session, manualized individual family~     resiliency training (IFRT) for families with one OEF/OIF/OND veteran in promoting better~     family communication relating to return to post military life.~   "
148225|NCT01626300|"~     The purpose of this study is to determine if the daily use of a certain amount and type of~     milk component for 2 months provides a significant stimulation to the immune system and~     specifically increases the chances of being protected against pneumonia after the~     vaccination.~   "
148226|NCT01626287|"~     Perineal trauma is common during vaginal birth. The discomfort this causes can interfere with~     a woman's recovery and early motherhood.Mothers are offered a standard treatment after~     childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. However,~     a Cochrane review questions the efficacy of ice packs treatment. An alternative treatment~     that may be more comfortable and effective for women is warm water soaked black tea bags.~     Medicinal use of black tea bags has been based on their astringent (shrinking or~     constricting) properties and have been used for various medical applications.~      The investigators will conduct a pilot randomized controlled trial (RCT) of 40 pregnant~     mothers randomized to either intervention group (tea bags; n=20) or control group (ice packs;~     n=20). The goal of this pilot is to test the feasibility of a larger RCT by assessing~     recruitment, testing the protocol, and evaluating a proposed primary outcome objective of~     analgesic use during hospitalization as an indicator of pain. The investigators expect this~     pilot study to demonstrate feasibility for a large scale RCT to formally evaluate the~     efficacy of black tea bags to reduce perineal pain in this patient population.~   "
148227|NCT01626274|"~     The purpose of this study is to evaluate the feasibility of non-intrusive 24 hours~     non-invasive measurements with minimized LAVIMO sensor system. The LAVIMO-system is a~     photoplethysmographic device for reflective mode measurements of the optical damping upper~     skin layers inside of the ear canal at two different wave lengths. It consists of the in-ear~     sensor, the electronics and a PC. Vital signs parameter like heart rate, heart rate~     variability, breathing and arterial blood oxygenation are monitored in patients with sleep~     apnoea and compared to measurements of standard polysomnography of these patients during one~     night in the sleep laboratory.~   "
148228|NCT01626261|"~     The number of active electrical cardiac implants such as internal cardioverter defibrillators~     (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the~     last two decades. This has been paralleled by an increase in the number of sources of~     electromagnetic fields in daily life and occupational circumstances.~      To date it remains unclear whether patients are at risk of device failure when being~     subjected to these fields. There are currently no general guidelines available to help~     clinicians informing their patients about safety levels and behavior around these~     electromagnetic fields.~      This study aims to identify the thresholds of safe use of these devices and potential~     failures under worst-case conditions in 50/60 Hz fields (i.e.~      power line frequency). Device implanted patients will be exposed to electric, magnetic and~     combined fields of different intensity at various device programming (e.g. nominal and~     maximum sensitivity). The results will show whether patients are safe in public or~     occupational environments, which medical relevant disturbances can occur and if a correlation~     exists between disturbances and device type or patients physique.~   "
148229|NCT01626248|"~     The purpose of the study is to research the association between receiving Tysabri®~     (natalizumab), interferon beta-1a, glatiramer acetate or not having any treatment for your MS~     and how it may or may not impact certain white blood cells and other immunological markers.~     This information may be useful in identifying risk factors in developing progressive~     multifocal leukoencephalopathy (PML). It does appear that the risk increases with the total~     number of natalizumab infusions. Patients who have not yet started a disease modifying~     therapy or who have been on one other than natalizumab are needed as controls to see how~     these biomarkers change.~      Patients at various stages of natalizumab treatment as well as natalizumab naïve are needed~     to allow for analysis of the change in potential markers over time.~   "
148230|NCT01626235|"~     Study aims to assess patient-recorded outcomes of pain control medications prescribed in the~     ER after visits for specific painful injuries/illnesses.~   "
148231|NCT01626222|"~     The present multi-center, open-label, single-arm study aims to evaluate the efficacy and~     safety, quality of life and health resources utilization in postmenopausal women with hormone~     receptor positive breast cancer progressing following prior therapy with non-steroidal~     aromatase inhibitors (NSAI) treated with the combination of Everolimus and Exemestane.~   "
148232|NCT01626209|"~     Dose escalation study with a dose expansion phase, to evaluate safety, tolerability,~     pharmacokinetics and preliminary efficacy of two dose levels of BKM120 when administered~     orally.~   "
148233|NCT01626196|"~     Several factors are important in achieving a successful colonoscopy, including patient~     acceptability of the bowel cleansing procedure and the overall quality of cleansing.~      This observational study has been designed to explore the main determinants of acceptability~     of the bowel cleansing procedure to the patient in an Italian real life setting. In~     addition, the study is to examine the determinants of quality of bowel cleansing and describe~     aspects of the technical performance of the colonoscopy (time to reach the caecum and adenoma~     detection rate).~   "
148234|NCT01626183|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors identify and learn more about biomarkers related to cancer~      PURPOSE: This laboratory study is looking into RNA in samples from younger patients with~     T-cell (T) acute lymphoblastic leukemia (ALL).~   "
148794|NCT01618851|"~     This phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT~     with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients will~     be treated with three radiosurgical treatments (6.5 Gy per fraction) followed by IMRT (45 Gy~     in 25 fractions).~   "
148236|NCT01626157|"~     Inflammation is present in the Cystic fibrosis (CF) airway from the time of infancy, and~     worsens with the onset of chronic infection. Therapies with proven benefit are associated~     with decreased airway inflammation. Thus, sensitive and reproducible biomarkers of airway~     inflammation have long been sought as a necessary component to improved clinical care and to~     facilitate therapeutic trials for CF. FEV1, the standard outcome measure in CF, is recognized~     as an insensitive outcome measure. the investigators have identified a panel of 10 genes~     which sensitively predict resolution of pulmonary inflammation, in response to therapy of an~     acute pulmonary exacerbation. With the goal of yielding a technically simple but unique CF~     biomarker assay, the investigators have tested whether proteins signified by these genes show~     large changes in expression following treatment of acute pulmonary exacerbations. Protein~     quantifications are among the most common measurements performed in clinical laboratories~     around the world. Based on preliminary findings that changes in white blood cell proteins~     mirror changes seen in the genes, the investigators propose to identify top candidate~     proteins, from the investigators gene panel, which change in response to exacerbation~     therapy. Once identified, these proteins will be quantified directly with a new blood test~     which is inexpensive and simple to perform. The investigators propose to validate this blood~     test in a single site trial. If successful, this proposal will yield a biomarker assay that~     will be available to validate in a multi-site trial and provide unique insights into~     mechanisms that regulate white blood cell activation and recruitment in CF lung disease.~   "
148237|NCT01626144|"~     It is the investigators hypothesis that exemestane (EXE) metabolism is an important source of~     the inter-individual variation in EXE metabolic profiles and that polymorphisms in~     EXE-metabolizing enzymes may potentially play a role in affecting EXE therapeutic efficacy~     and toxicity. The goals of this clinical study are to (1) establish EXE metabolism profile~     kinetics, and (2) determine whether correlations exist in vivo between metabolizing enzyme~     genotype and urinary EXE metabolite profiles in women being treated with EXE. Together, these~     studies will allow us to fully characterize functionally-relevant polymorphisms in the~     EXE-metabolizing enzyme pathway that are potentially important in EXE clinical efficacy.~   "
148238|NCT01626131|"~     The primary objective of this pilot intervention study is to examine the efficacy of exercise~     for reducing the symptoms of posttraumatic stress disorder (PTSD) and other psychiatric and~     somatic symptoms. The sample will be composed of veterans aged 18-65 with combat-related PTSD~     (N = 40). Participants will be randomly assigned to one of two groups. Participants in the~     exercise training group (n = 20) will receive three 60-75 minute sessions per week of~     combination aerobic and resistance training for eight weeks. In the control stretching group,~     participants (n = 20) will receive training in whole-body flexibility three times per week~     for eight weeks. Secondary objectives include 1) determining feasibility of the intervention~     (as measured by the percentage of prescribed days of exercise completed by each participant,~     and percentage of time exercising completed at the prescribed intensity and duration); 2)~     determining the influence of exercise training on aerobic fitness and strength in the sample;~     and 3) determining whether psychiatric/somatic symptom improvements are associated with~     improvements in fitness and strength. Finally, exploratory objectives will include examining~     whether exercise training can improve early signs of heart disease, and whether certain~     biomarkers (using MRI and fMRI data and inflammatory markers) are associated with treatment~     response.~   "
148239|NCT01626118|"~     The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and~     effective for the treatment of postoperative bunionectomy pain.~   "
148240|NCT01626105|"~     This study is designed to accurately identify the pharmacogenetic determinants of risk of~     Factor VIII (FVIII) inhibitor development by focusing on only a select group of Hemophilia A~     (HA) patients who have: (i) received a recombinant FVIII therapeutic product containing the~     same primary amino acid sequence since their original diagnosis; (ii) verifiable FVIII~     infusion histories; and (iii) been tested regularly for FVIII inhibitor development.~   "
148241|NCT01626092|"~     This study is designed to test the ability to achieve donor hematopoietic engraftment while~     maintaining low rates of transplant-related mortality (TRM) in patients with high-risk~     lysosomal and peroxisomal disorders using a novel conditioning regimen for hematopoietic cell~     transplantation (HCT). After a reduced-intensity conditioning regimen using~     volumetric-modulated arc therapy (VMAT)-delivered low-dose total body irradiation (TBI) with~     highly conformal marrow boosting, patients will be transplanted using either a related or~     unrelated allograft. The cell source may be marrow, peripheral blood or cord blood based on~     donor availability.~   "
148242|NCT01626079|"~     The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy~     for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm~     the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe~     or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are~     treated per standard of care and who have been determined by the site's local heart team as~     not appropriate for mitral valve surgery. This randomized controlled trial will provide the~     opportunity to strengthen or add labeling claims regarding safety and clinical benefits of~     the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe~     functional mitral regurgitation.~      Approximately 610 subjects will be randomized at up to 100 investigational sites with~     approximately 305 subjects targeted to receive the study device.~      As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary~     exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise~     responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group)~     compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study~     subjects will contribute to the analyses of the COAPT primary and secondary endpoints)~      As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT~     enrollment is complete under the same investigational device exemption (IDE(G120024)). The~     objective of this study is to evaluate the MitraClip® NT System for the treatment of~     clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure~     subjects who are treated per standard of care and who have been determined by the site's~     local heart team as not appropriate for mitral valve surgery. The anticipated study Primary~     Completion date is July 2020 and the Study Completion Date is July 2024.~   "
148243|NCT01626066|"~     Real-time detection of cancer cells during surgical removal of a tumor is important.~     Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology~     when the margins (edges of the tissue) are examined to see if cancer cells are present. This~     may take a few to several days. Patients tissue with positive (cancer cells present) margins~     may require additional therapies including surgery. The purpose of this study is to determine~     a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that~     will show in the tumor area during surgery and may help facilitate visualization of tumor for~     its removal.~   "
148986|NCT01616342|"~     The purpose of this study is to determine the degree to which spinal cord stimulation added~     to comprehensive medical management can provide increased relief of chronic pain in patients~     with injuries sustained while on active military duty, measured by patient assessments of~     pain.~   "
148244|NCT01626053|"~     It is hypothesized for this study that the coupling of the Millon Behavioral Medicine~     Diagnostic, biopsychosocial evaluation, motivational interviewing, relapse prevention, and~     ongoing support can produce improved outcomes with diabetics who have previously been~     unsuccessful with the traditional care. This study examined the relationship between~     patients' HbA1c levels and patients' involvement in the ASMART program, a multifaceted~     program involving psychological intervention. The study was conducted through the Kosciusko~     Health Department and funded by K21 Health Foundation.~   "
148245|NCT01626040|"~     The purpose of this study is to examine the effects of current standard of care Polyethylene~     Gylcol powder (PEG-P)colonoscopy preparation on a patient's serum electrolytes, tolerance of~     the prep, and how well the bowel is cleansed. The primary aim is to determine the proportion~     of patients with clinically significant serum electrolyte abnormalities at the time of~     colonoscopy and how well the prep is tolerated. Secondary objectives include: 1) how well the~     bowel is cleansed with this preparation, and 2) to determine the most effective way to~     communicate instructions about the bowel preparation with the child and family.~   "
148246|NCT01626027|"~     The aims of this prospective, observational study are to assess the current use of depression~     care in Coronary Heart Disease (CHD) patients, and to provide estimates for the resources~     needed to implement guideline-oriented depression health care acceptable to CHD patients with~     comorbid depression.~   "
148247|NCT01626014|"~     Ovarian cancer accounts for more deaths than any other gynecologic malignancy. The majority~     of patients are diagnosed with Stage III-IV disease. Nearly 80% of these patients will recur~     resulting in 5-year survival rates of 14-32%. Although enrollment is increasing in hospice,~     hospice programs have been challenged to reach eligible patients. Several factors limit the~     number of people who enroll in hospice and the length of their hospice stay. Prognostication~     challenges and the increasing availability of cancer therapies for people with cancer set the~     stage for a mismatch between certification of a 6 month prognosis and contemporary medical~     care. Additionally patients often are not aware of hospice and the services they can provide.~   "
148248|NCT01626001|"~     The goal of this clinical research study is to learn about ways to possibly reduce scanning~     errors when using 4-dimensional computed tomography (4D CT) scans to check lung function in~     patients with esophageal or lung cancer.~   "
148249|NCT01625988|"~     To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in~     migraineurs with or without aura during 3 months of treatment.~   "
148250|NCT01625975|"~     Understanding bone growth and achieving bone deformity corrections re-mains one of the oldest~     challenges in paediatric orthopaedics.~      The purpose of this study is to investigate the clinical and biomechanical effects of~     implants for growth modulation in pediatric patients undergoing correction of leg length or~     deformities of the knee.~      The primary aim of the study is to assess outcome after growth modulation using the Eight~     plate (Orthofix) at the time of implant removal with regard to any Adverse Events (AE)~     related to the growth plates or implants under investigation. The secondary aims are to~     assess if the planned correction was achieved and if the achieved correction was maintained~     after implant removal. Furthermore, secondary aims include investigation of the number and~     type of revision surgeries, the proportions of any other local AE as well as any influencing~     factors for growth modulation.~   "
148251|NCT01625962|"~     This is a prospective, longitudinal cohort study to evaluate the associations between indices~     of brain structure and function (measured at baseline, as soon as possible after injury) and~     course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be service members~     who have sustained mild traumatic brain injury (classified as either impact-induced mTBI or~     blast-induced mTBI; n = 100 completers) or an extracranial injury (ECI) with no evidence of~     traumatic brain injury (TBI) (n = 100 completers). Subjects will complete an assessment~     battery at baseline and 6 months later that includes (1) structural magnetic resonance~     imaging (MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla magnet; (2)~     event-related brain potentials (ERPs) derived from brain electrical activity; (3)~     neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain~     structure and function derived from these assessments are hypothesized to demonstrate a~     significant relationship with course of PTSD symptoms, which will be measured at baseline, 3~     months, and 6 months.~   "
148252|NCT01625949|"~     Background: When an acute myocardial infarction occurs, the artery supplying the infarct zone~     should be opened within twenty four hours of onset of infarction. This has clearly been shown~     to be beneficial.~      If the patient presents later than 24 hours of onset, at that stage a large part of the~     damage to the heart is irreversible. Intervening at this stage (beyond 24 hours is~     controversial). Some trials suggest that opening the artery even at this stage positively~     modifies the remodeling process while other trials suggest that such a benefit is not seen.~      Hypothesis: Opening an infarct related artery after 24 hours (until 6 months) and combining~     it with intracoronary stem cell therapy may provide incremental benefit.It is possible that~     the lack of benefit seen with late revascularization (>24 hrs) after MI may be offset by~     giving intracoronary stem cells after opening the artery.~   "
148253|NCT01625936|"~     This is a Phase 1b, dose escalation study of the investigational agent, CRLX101, given in~     combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of~     this study is to determine the initial safety and effectiveness of this agent in combination~     with Bevacizumab. The investigators are also trying to determine the best dose level of~     CRLX101 to give in combination with bevacizumab. About 22 subjects will be enrolled in this~     study at the University of Pennsylvania.~   "
148274|NCT01625663|"~     Barth syndrome (BTHS) is an X-linked disorder caused by abnormal cardiolipin metabolism and~     is characterized by skeletal and cardiomyopathy and high mortality rates. Through clinical~     metabolism and imaging studies and pluripotent stem cell induction and molecular techniques~     on skin biopsy samples, this project will produce novel translational information regarding~     the pathogenesis of BTHS, reveal potential targets for interventions and provide unique data~     regarding nutrient metabolism and abnormal cardiolipin and mitochondrial function. This~     project has the potential to provide information that could significantly improve morbidity~     and mortality in children and young adults with BTHS and may have relevance to other non-BTHS~     related conditions such as aging and adult heart failure.~   "
155797|NCT01526902|"~     This study is designed to compare the relative performance related to subjective and~     objective vision between two multifocal soft contact lenses.~   "
148254|NCT01625923|"~     Gastroparesis is a disorder characterized by impaired gastric emptying in the absence of~     obstruction in the proximal GI tract. It is a common condition affecting up to 5 million~     persons in the United States alone. Despite this, metoclopramide is currently the only FDA~     approved medication for the treatment of gastroparesis. However, the evidence supporting~     metoclopramide in gastroparesis is fairly weak and was recently issued a black box warning~     because of potential irreversible side effects. There is clearly an urgent need for newer~     therapeutic options with better efficacy and tolerability. Olanzapine is a second generation~     anti-psychotic that is currently FDA approved for the treatment of schizophrenia and bipolar~     disorder. Because of actions at several receptors throughout the body, including dopamine and~     serotonin receptors, Olanzapine may provide anti-nausea and pro-motility effects in the~     stomach. Long-term use of olanzapine may also increase plasma levels of ghrelin. Ghrelin is a~     hormone produced by the gut that stimulates appetite and has also been shown to have~     beneficial effects on gastroparesis. The investigators hypothesize that olanzapine will be~     effective and safe in controlling symptoms as well as stimulate appetite and weight gain in~     gastroparesis. The investigators also hypothesize that olanzapine will stimulate gastric~     motility. Finally, the investigators hypothesize that olanzapine will modulate the secretion~     of ghrelin in gastroparesis. This pilot study may provide further information on the efficacy~     and safety of olanzapine in gastroparesis which could be utilized in a larger randomized,~     prospective study in the future.~   "
148255|NCT01625910|"~     Childhood obesity is a major public health problem in the U.S. Currently approximately one in~     three children is considered overweight or obese. Most overweight children grow to become~     overweight adults. It is unclear how effective pediatricians and other primary care~     physicians can be in assisting overweight children to normalize their body weight. Expert~     guidelines have been established, but are currently untested.~      This study will randomize overweight and obese children between the ages of 4 and 8 years old~     to either the recommended treatment guidelines or a control (non-intervention) group.~      The purpose of this study is to evaluate the ability (a) to recruit overweight children~     between the ages of 4 and 8 years old (b) to remeasure the children three months after~     enrollment and (c) to reduce childhood obesity via implementation of the recommended~     treatment guidelines.~   "
148256|NCT01625897|"~     The objective of this study is to evaluate the long-term safety, tolerability, and efficacy~     of MP-214 in patients with chronic phase or elderly schizophrenia.~   "
148257|NCT01625884|"~     In Turkey statin compliance is lower than EU countries. (EURIKA). We will assess the~     underlying causes of statin incompliance. The investigators will build patient and physician~     education programs to improve compliance in TURKEY. Our aim is to assess patients' and~     physicians' attitudes to statins by mean of HABIT Patient and Physician survey respectively.~   "
148258|NCT01625871|"~     The cure rate of artemether/lumefantrine in the treatment of vivax malaria.~   "
148259|NCT01625858|"~     The supraglottic airway device LMA Supreme has recently been introduced for pediatric~     patients. The investigators will prospectively evaluate success rate and airway leak pressure~     in everyday's clinical pediatric anesthesia practice. Primary hypothesis is that the LMA~     Supreme has a leak pressure with a 95% confidence interval of 18-22cmH2O. Leak pressures will~     be compared to results from other pediatric supraglottic airway devices previously studied by~     the investigators group. Secondary Hypothesis: The primary success rate of the LMA-S is~     higher than 90%; therefore, performance is similar to the performance of the Ambu Aura Once™~     and of the i-gel™. Study design: Prospective controlled observational cohort study.~      In a second step, we will include more pediatric supraglottic airway devices. Each new arm~     will be handled exactly the same, assuming the same hypothesis being justified.~   "
148260|NCT01625845|"~     The objective of this clinical trial is to evaluate whether an anti-inflammatory medication,~     pentoxifylline, reduces depressive symptoms and improves artery function. Participants in~     this trial will be older primary care patients (60 years and up) who are depressed but do not~     have a history of cardiovascular disease. Half of these patients will receive pentoxifylline,~     and half will receive placebo. In addition, participants in both arms will receive an~     evidence-based psychological treatment called Beating the Blues®, which is a computerized,~     cognitive behavioral treatment program for depression. The investigators will use~     questionnaires to assess change in depressive symptoms and an ultrasound test to measure~     change in artery function from pre- to post-treatment. It is hypothesized that patients who~     receive pentoxifylline will show greater improvements in both depression and artery function~     than patients who receive placebo.~   "
148261|NCT01625832|"~     Coronary artery disease (CAD) is the leading cause of morbidity and mortality in~     industrialized countries despite advances in medical, interventional, and surgical~     revascularization therapies. In both, acute myocardial infarction (AMI) and chronic stable~     disease, standard therapeutic approaches may fail to restore tissue perfusion. Indeed, a~     substantial number of chronic CAD patients may not be amenable to standard revascularization~     therapies or percutaneous coronary intervention (PCI) may fail to restore coronary artery~     patency following an acute vessel occlusion (no-reflow phenomenon, microvascular~     obstruction). As a consequence, the long pursued strategy of augmenting myocardial perfusion~     by diverting blood from the coronary venous system to an ischemic region (venous~     retroperfusion) has again gained attention during recent years. Occlusion of the coronary~     sinus (CSO) was introduced to provide retroperfusion by transient augmentation of coronary~     venous pressure. Different devices using CSO have been invented and evaluated in animal~     models and small clinical trials, e.g. intermittent CSO (ICSO) and pressure-controlled~     intermittent CSO (PICSO) which seem to be effective for myocardial salvage. However, they are~     not yet employed in clinical routine, and importantly, the exact underlying mechanisms by~     which retroperfusion due to CSO may reduce myocardial ischemia are not yet understood.~      As natural bypasses, coronary collaterals are anastomoses without an intervening capillary~     bed between portions of the same coronary artery or between different coronary arteries that~     represent an alternative source of blood supply to a myocardial area jeopardized by ischemia.~     Collaterals of the heart can be assessed quantitatively by coronary pressure measurements,~     which have become the gold standard (collateral flow index, CFI=[Poccl-CVP]/[Pao-CVP]).~     Theoretically, augmentation of coronary sinus pressure by CSO with an increase of venous~     backflow reaches the upstream collateral circulation, which in turn could lead to improved~     collateral flow from non-ischemic area(s) to an occluded, ischemic myocardial region by~     upstream flow diversion. On the other hand, when considering the formula to calculate~     pressure-derived CFI, it seems that augmentation of coronary back pressure would rather~     impair collateral flow (since central venous pressure is coronary sinus pressure). However,~     the regional effect of a global increase in coronary sinus pressure is unlikely to be as~     uniform as the above formula implies, i.e., the response is more pronounced in some than in~     other vascular territories. In experimental studies using dogs (with abundant collaterals),~     elevation of coronary sinus pressure caused an augmentation of regional myocardial blood flow~     in the collateralized area. In contrast, when ICSO was performed in pigs (which possess no~     preformed collaterals), it increased the pressure distal of an occluded LAD but did not~     improve blood flow or left ventricular function.~      In conclusion, experimental studies and pathophysiologic considerations suggest a necessary~     role of the collateral circulation for the beneficial effects of coronary sinus occlusion~     (CSO) observed in animals and humans; however, no clinical data are available so far on the~     effect of CSO on myocardial ischemia in the presence of varying collateral flow.~      Study hypotheses~        1. CSO decreases intra-coronary ECG ST-segment elevation during a 2-minute coronary~          occlusion.~        2. The decrease in occlusive intra-coronary ECG ST elevation during CSO is directly~          proportional to CFI.~        3. Coronary sinus oxygen saturation during coronary occlusion with CSO is directly~          proportional to CFI.~   "
148262|NCT01625819|"~     The objective of this research is to compare Tai Chi versus Resistance Exercise, Health~     Education and usual care for changes in cardiac functional capacity measured for ability of~     the heart to pump by measuring ejection fraction (EF), end systolic and diastolic volumes in~     heart failure (HF) patients. Also measured will be changes in physical function measured by~     walking speed and distance in the 6-min walk task, work performed during a bicycle task, and~     changes in daily physical activity. The investigators will compare groups for altered~     well-being including: depression, sleep disturbances, fatigue, mindfulness, spirituality and~     quality of life. In addition the investigators will compare groups for altered vascular and~     pro-inflammatory markers, catecholamines, and autonomic function at rest and in response to~     the bicycle task. Also, the investigators will assess cardiac related hospitalization and~     death over a 12 month period by examining medical records.~   "
148263|NCT01625806|"~     This single-center, open-label, parallel group study will evaluate the effects of multiple~     doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male~     volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects~     assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours)~     from Day 1 to Day 17.~   "
148275|NCT01625650|"~     The CORRONA CERTAIN Sub-study of the Consortium of Rheumatology Researchers of North America,~     Inc. is a Sub-study of the CORRONA Data Collection Program.~      The CERTAIN Sub-study is designed to systematically collect and document use patterns,~     effectiveness, comparative effectiveness and safety of biologic agents used in the management~     of Rheumatoid Arthritis (RA).~   "
149008|NCT01616056|"~     This phase II clinical trial studies how well bandage lenses work in treating patients with~     ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and~     damage caused by eye graft versus host disease.~   "
148264|NCT01625793|"~     The current study has been designed to identify behavioral and physiological mechanisms~     through which positive social connectivity (PCS) and negative social processes (NSP) interact~     with psychosocial stress to promote resilience in the context of illness. The investigators~     model inflammation (a central element of all disease states) through the use of treatment~     with interferon (IFN)-alpha, which provides a standardized regimen of chronic cytokine~     exposure known to produce profound behavioral disturbances, including depression, fatigue and~     sickness, in a high percentage of individuals. To objectively assess social processes, the~     current project will employ the Electronically Activated Recorder (EAR), which periodically~     and unobtrusively records snippets of ambient sounds in people's momentary environments. To~     objectively assess behavioral and physiological responses to psychosocial stress the current~     project will employ the Trier Social Stress Test (TSST), a standardized laboratory stressor~     known to reliably activate behavioral, neuroendocrine and inflammatory responses. These novel~     methodologies and model systems will be employed to test the hypotheses that (a) pre-existing~     affiliative and prosocial behavior will promote resilience in the context of chronic~     inflammation and that (b) —conversely—chronic inflammation will reduce affiliative and~     prosocial behavior via effects on stress reactivity, neuroendocrine function and sleep.~     Finally, it will explore (c) the potential mediating role of stress physiology. To test these~     hypotheses, 110 subjects with chronic hepatitis C virus infection will be randomized to~     receive treatment with pegylated IFN-alpha plus ribavirin or to postpone treatment for 6~     weeks: 55 subjects at University of Arizona and 55 subjects at Emory University. Prior to~     randomization and 6 weeks later all subjects will be evaluated with the EAR and sleep~     actigraphy in their home environments and will undergo TSST and 14 hour diurnal~     neuroendocrine and immune measurement.~   "
148265|NCT01625780|"~     Ilio-inguinal nerve blocks have a long history of efficacy in treatment of post-operative~     pain following inguinal surgery. Several anatomic studies have shown that the nerves~     supplying the inguinal area have a certain degree of variability with respect to their~     location between the internal and external oblique layers of the anterior abdominal wall.~     Furthermore, the standard single-shot approach to ilio-inguinal nerve blocks has a~     significant incidence of unintended femoral nerve block, which can impair patients' ability~     to walk after surgery. The investigators are proposing a new approach to the ilio-inguinal~     nerve block, which divides the total dose of local anesthetic into 3 equal parts, injecting~     each 1/3 into different layers of the anterior abdominal wall and sub-cutaneously. The~     investigators intend to show that this new technique, the Tsui approach, provides equal~     analgesia to the standard single-shot ultrasound-guided ilio-inguinal nerve block, while~     being faster to perform and having a lower incidence of unintended femoral nerve blockade.~     Patients under age 10 who are scheduled for elective inguinal surgery (hydrocele repair,~     orchidopexy, and inguinal hernia repair), who have already consented to an ilio-inguinal~     nerve block that is commonly placed for this type of procedure, will be approached to~     participate in this study. No increased risk is anticipated for these patients, as both~     ultrasound-guided and blind techniques are equally well-accepted in the literature for this~     type of block, and in addition there are few vascular or neural structures in this anatomical~     area (just medial and inferior to the anterior superior iliac spine) that may be damaged.~     Follow-up will be limited to an assessment of pain scores in the PACU post-operatively and~     any unintended femoral nerve blockade in post-PACU. This will not delay their hospital~     discharge as these are same-day surgery patients.~   "
148266|NCT01625767|"~     This is a two part study. Study 1 will compare Approach Avoidance Training (AAT) responses in~     smokers and nonsmokers in order to confirm that adolescent smokers experience cognitive bias~     towards tobacco-related stimuli.~   "
148267|NCT01625754|"~     Many studies have shown that those with coronary artery disease (CAD) have a more rapid~     decline in memory than expected and that they are at an increased risk of developing~     dementia. It is not understood how memory decline is linked to CAD; however, it has recently~     been discovered that certain byproducts of fat breakdown involved in the development of CAD,~     called ceramides, can harm brain cells. In the present study the investigators will recruit~     129 CAD patients from a cardiac rehabilitation facility and measure memory performance and~     blood ceramide concentrations at baseline, 3 months and 6 months. The investigators will also~     measure important blood messengers of inflammation and assess whether they are associated~     with ceramide production. In addition, relationships between ceramides and other aspects of~     brain function, such as thinking speed and the ability to plan and sort information will be~     explored.~   "
148268|NCT01625741|"~     This study explores the potential to improve the quality of response obtained after induction~     treatment in Chronic Lymphocytic Leukemia (CLL), by giving a short and intense consolidation~     schema using high-dose rituximab. Patients in suboptimal response (Minimal Residual Disease~     persistence) after induction will be selected, as well as those who have a Minimal Residual~     Disease (MRD) relapse after having achieved MRD negativity.~   "
148269|NCT01625728|"~     The purpose of the study A comparison of vocal demands with vocal performance among~     classroom teachers is to gather information about the voice production of teachers using~     three separate strategies: (a) measures of voice assessed with the Computerized Speech Lab~     (CSL) and the Phonatory Aerodynamic System (PAS) instruments in the SIUC Voice Lab.~   "
148270|NCT01625715|"~     The primary objective of this study is to evaluate, compared to non-treatment, the impact of~     a titrated dose (1 mg once a day, then 1 mg twice a day and finally a full 2 mg twice a day)~     of ketotifen on the adverse event profile emerging from a rapid peanut desensitization~     protocol, in children with established peanut allergy.~   "
148271|NCT01625702|"~     To identify the correlation of CTCs with clinical prognosis in advanced/metastatic gastric~     cancer. Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.~   "
148272|NCT01625689|"~     In this Phase II randomized controlled clinical trial, generally healthy male and female~     children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh.~     The study is expected to continue for at least 6 months following vaccination. The~     experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live~     Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to~     WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is~     administered in a 0.5 ml intranasal dose (one spray of 0.25 ml per nostril) via a reusable~     sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited~     in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in~     appearance to the active vaccine.~      The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24~     through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among~     children receiving study vaccine as compared to children receiving placebo.~   "
148273|NCT01625676|"~     The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia~     Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT~     versus standard treatment with the same intensity of intervention.~   "
148307|NCT01625234|"~     This is the first human study to use X-396 (ensartinib), a drug being developed for treatment~     of advanced cancers. The initial purpose of the study is to determine the largest amount of~     X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended~     Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor~     activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide~     early information on how the body handles the drug (pharmacokinetics) and on the efficacy of~     X-396.~   "
156792|NCT01513850|"~     The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a~     study drug) after liver transplantation.~   "
148276|NCT01625637|"~     This is a two part study. In Study 2, smokers who want to quit smoking will participate in a~     4 week smoking cessation program combining weekly cognitive behavioral therapy (CBT) with~     weekly regular-AAT or placebo-AAT training. We hypothesize that adolescent smokers will~     exhibit stronger approach tendencies towards smoking-related stimuli in the tobacco Approach~     Avoidance Training (AAT) task when compared with nonsmokers and that adolescent smokers who~     are trained to avoid smoking related stimuli using the AAT will avoid tobacco approach~     tendencies in the AAT test trials and the Implicit Association Task, when compared to~     adolescent smokers who are not exposed to AAT training. We also hypothesize that adolescent~     smokers who are trained to avoid tobacco in a training AAT in combination with CBT will have~     better abstinence rates compared to those who receive placebo AAT training with CBT.~   "
148277|NCT01625624|"~     The purpose of this study is to determine the effect of food products varying in composition,~     on energy in healthy adult subjects.~   "
148278|NCT01625611|"~     The primary purpose of the study is to increase our knowledge of receptor function in the~     brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has~     been approved for the treatment of alcohol dependence. Receptors are special molecules in the~     brain to which other molecules (neurotransmitters) attach during the normal every-day~     workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence~     suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking~     behavior. This study will try to determine if naltrexone's ability to attach to these~     receptors is related to its effectiveness. We will use PET (positron emission tomography) for~     this study. PET is a type of imaging device found in nuclear medicine. It is used for~     tracking the presence of injected radioactive materials in the body.~   "
148279|NCT01625598|"~     The hypothesis is that computer detection of the severity of diabetic retinopathy including~     the presence of clinically significant macular edema is not inferior to the detection using a~     dilated eye examination by a Board-certified ophthalmologist.~   "
148280|NCT01625585|"~     The goal of the present study is to investigate the clinical outcomes of patients with~     gastrointestinal bleeding originating from the small intestine following diagnostic~     investigation with single balloon enteroscopy. We hypothesize that single balloon enteroscopy~     can arrive at a diagnosis and provide therapeutics in a majority of patients with~     gastrointestinal bleeding originating in the small intestine.~   "
148281|NCT01625572|"~     The purpose of this study is to compare the quality of a transversus abdominis plane blockade~     with an intravenous pain therapy with opioids. Due to the relatively low side effect profile~     and comparably few contraindications, this method offers a good option, to be a standard~     procedure or better alternative in the treatment of pain in surgery of the prostate.~   "
148282|NCT01625559|"~     The purpose of this study is:~        -  To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD~          Group~        -  When-MA09-hRPE cell transplantation to evaluate the safety of surgical procedures.~        -  In future studies intended to assess the number of transplanted hRPE cells.~        -  In the past, MA09-hRPE cell therapy used in the study was to evaluate the validity of~          the potential.~        -  Homologous retinal pigment epithelial cells derived from embryonic stem cells, future~          studies of drugs that are used in representing the potential validity to evaluate the~          optimal dose.~   "
148283|NCT01625546|"~     Major depressive disorder (MDD) is predicted to be the second leading cause of disability~     worldwide by the year 2020. The economic burden of depression in the United States is~     significant: $83.1 billion in 2000 and increasing. Much of this burden comes from the high~     rate of sub-optimal treatment outcomes associated with the disorder. Indeed, only 50% of MDD~     patients recover in less than 12 weeks with adequate treatment, and up to 20% of patients~     will fail to adequately respond to all currently available interventions. Moreover, current~     treatments come at the cost of significant central nervous system (CNS) side effects, further~     highlighting the need for more effective treatments with fewer side effects. This study will~     compare temperature ranges from the investigators preliminary studies involving~     thermoafferent pathways resulting in antidepressant actions with lower temperature ranges not~     expected to activate these pathways as a control condition, with the goal to evaluate whether~     previous observations were related to the temperature range in question or can be achieved~     with other levels.~   "
148284|NCT01625533|"~     The purpose of this study is to assess the clinical safety and efficacy of dual-axis~     rotational coronary angiography (DARCA) in the diagnosis of coronary artery disease by~     directly comparing it to standard coronary angiography (SA).~   "
148285|NCT01625520|"~     A mono centre study to evaluate the efficacy of SOM230 in patients with progressive~     metastatic or postoperative persistent medullary thyroid cancer.~   "
148286|NCT01625507|"~     The study hypothesis is that individuals with type 2 diabetes (T2D), who adhere to the PANDA~     intervention, will have improved compliance with the nutritional therapy recommendations of~     the Canadian Diabetes Association. Specific objectives of this proposal: The objectives of~     the investigators PANDA (Physical Activity and Nutrition for Diabetes in Alberta) are to (a)~     to devise and evaluate the efficacy of a multi-level, practical, nutrition intervention~     program that promotes the individual factors required for effective self-management practices~     AND that explicitly incorporate strategies to improve food availability, accessibility and~     acceptability and (b) to use these interventions as a means to examine the relationships~     between food availability, accessibility, acceptability, adherence to Nutrition Therapy~     Guidelines, and metabolic indicators of diabetes control in people with type 2 diabetes.~   "
148287|NCT01625494|"~     Primary Objective:~      - To assess the proportion of patients with controlled Office Blood Pressure Measurements~     (OBPM), defined as Systolic blood pressure < 140 mmHg and Diastolic blood pressure <90mmHg,~     at the end of the study~      Secondary Objectives:~        -  To examine over time the antihypertensive effect of the 4 doses of the fixed combination~          therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic~          blood pressure)~        -  To examine the proportion of patients with controlled OBPM (systolic BP<140 mm Hg and~          diastolic BP<90 mmHg) of the different dose groups over time~        -  To determine the incidence and severity of adverse events.~   "
148288|NCT01625481|"~     The purpose of this study is to further assess the safety and performance of Seal-V as an~     adjunct to standard surgical procedure for achieving hemostasis in patients undergoing~     peripheral vascular reconstruction surgeries using synthetic grafts.~   "
148289|NCT01625468|"~     The burden of tobacco use falls disproportionately on low-income populations, through high~     rates of primary smoking and exposure to secondhand smoke. The remarkable progress in~     creating smoke-free environments in the U.S. over the past two decades has left smoker's~     homes as one of the primary sources of exposure to secondhand smoke for both children and~     nonsmoking adults. Intervention research that identifies effective and practical strategies~     for reaching the minority of households that still allow smoking in the home has considerable~     potential to reduce smoke exposure, but suitable channels to reach low-income families are~     limited. The proposed research will develop, evaluate and disseminate a brief smoke-free~     homes intervention through the established national infrastructure of 2-1-1 call centers.~     2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies~     or 4-1-1 for directory assistance, that links callers to community-based health and social~     services.~      The proposed research has four specific aims: 1) Conduct formative research on intervention~     messages and materials for promoting smoke-free homes in low-income populations, applicable~     to both smokers and nonsmokers as household change agents; 2) Conduct a randomized controlled~     trial in the Atlanta 2-1-1 service area to evaluate the efficacy of a brief intervention to~     create smoke-free homes among 2-1-1 callers; 3) Conduct replication studies in Houston and~     North Carolina 2-1-1 systems to systematically test the intervention in varied populations~     and tobacco control climates, and 4) Disseminate the research-tested smoke-free homes~     intervention through a variety of mechanisms including a national grants program to 2-1-1~     systems and through the Tobacco Technical Assistance Consortium's linkages to the state and~     local tobacco control infrastructure in the U.S.~   "
148290|NCT01625455|"~     The purpose of this randomized, double-blinded, placebo-controlled study is to test the~     hypothesis that administration of aprepitant will decrease the severity of pruritus in~     patients with Sèzary Syndrome.~   "
148291|NCT01625442|"~     The metabolic syndrome is associated with increased risk of cardiovascular disease and~     diabetes mellitus. The age-adjusted prevalence of the metabolic syndrome in the United States~     is 34% for men and 35% for women. Emerging alternative medicine worldwide led investigators~     to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit)~     in treatment of metabolic syndrome. Serum total cholesterol, serum LDL cholesterol, serum HDL~     cholesterol, serum triglyceride, Fasting Blood Sugar and hematocrit measured before and after~     45 days of treatment.~   "
148292|NCT01625429|"~     This is a single-center, prospective, single arm phase II study to evaluate the efficacy and~     safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as~     neoadjuvant therapy in operable locally advanced breast cancer patients. The primary~     objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample~     size is 30.~   "
148293|NCT01625416|"~     After traumatic injuries some people have difficulty returning to the routine of their~     everyday activities and may experience physical and emotional pain. The purpose of this study~     is to identify new ways of providing support for physically injured trauma survivors. All~     study procedures are designed to work around patient needs and be as flexible as possible in~     order to best fit into patients' post-injury recovery.~      Patients who are eligible for the study are randomly assigned to receive care as usual, or~     the new method of treatment, with the study Trauma Support Specialist (TSS). This TSS will~     be in contact with the patient for the next three months; they may visit the patient at the~     hospital or at outpatient medical appointments. The TSS will also be available to talk with~     the patient over the telephone. Overall, the TSS will be working with the patient to help~     with difficulties returning to his or her routine and overcoming physical and emotional pain~     experienced after the injury. We believe that patients who receive the new method of~     treatment, will be more able to return to daily routines and/or cope with the emotional~     stress that can occur after an injury. Intervention technology innovations including mHealth~     applications and web-based links will be included in the investigation.~   "
148294|NCT01625403|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant human B-type~     natriuretic peptide (rhBNP) on heart and renal function in patients with acute decompensated~     heart failure (ADHF) and acute renal injury (AKI).~   "
148295|NCT01625390|"~     Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one~     of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient~     levels. In a person with haemophilia, the clotting process is much slower and the person~     experiences bleeding episodes that can result in serious problems and potential disability.~      The current haemophilia standard of care is to maintain FVIII activity level above 1%.~     Sometimes, patients can develop antibodies (so called inhibitors) against FVIII and it is~     no longer effective at controlling bleeds. Bleeds in these patients are currently treated~     using other proteins involved in the clotting process.~      The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds~     in inhibitor patients. This study consists of two parts, A and B. The purpose of part A is~     to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to~     efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The~     purpose of part B is to confirm efficacy and safety of the dose found in part A in all~     participating patients (confirmatory part). Part B is expected to last 12-32 months.~      Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or~     B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6~     months, will participate in this study.~      Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response~     is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be~     required to keep an electronic diary.~   "
148296|NCT01625377|"~     The aims of the study was to evaluate the safety and efficacy of early introduction one month~     post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de~     novo liver transplant recipients and to evaluate if it leads to a better renal function 6~     month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS.~      The renal function was estimated by glomerular filtration rate.~   "
148308|NCT01625221|"~     The purpose of this feasibility study is to obtain preliminary safety and effectiveness~     information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX~     System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).~   "
148456|NCT01623284|"~     The study is designed to determine whether there are clinical features that can be used as~     biomarkers to predict whether underlying Alzheimer's pathology is the cause of a speech and~     language based dementia. The primary hypothesis is that the proportion of patients who test~     positive for beta-amyloid deposition will vary across different speech and language based~     dementias.~   "
148457|NCT01623271|"~     The purpose of this study is to see if an FDA-approved drug (Gralise) can help people with~     certain types of neuropathic pain without causing too many side effects.~   "
181006|NCT01195675|"~     The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c)~     interval more than placebo~   "
148297|NCT01625364|"~     The purpose was to evaluate effectiveness and impact of an academic and counseling asthma~     health education program (SHARP) for fourth- and fifth-grade students diagnosed with asthma.~     Students attending schools randomized to the low-dose control condition received Open Airways~     for Schools (OAS). The first aim was to evaluate the effectiveness of SHARP, compared to the~     low-dose group, for students on cognitive, psychosocial, and behavioral aspects of asthma~     management at 1, 12, and 24 months post-intervention. We hypothesized that compared to~     students enrolled in elementary schools who received the low-dose program, students in~     elementary schools that received SHARP would increase asthma knowledge (cognition) and~     logical reasoning abilities for managing acute episodes (cognition), acceptance of asthma as~     a chronic condition (psychosocial), and use of effective asthma health behaviors (behavior).~     The second aim was to evaluate the long-term impact of SHARP, compared to the low-dose group,~     for students on condition characteristics, use of healthcare services, and quality of life at~     12 and 24 months post intervention. We hypothesized that compared to students enrolled in~     elementary schools who received the low-dose program; students in elementary schools who~     received SHARP would decrease asthma severity, use of healthcare services, and school~     absenteeism due to asthma, and increase participation in life activities (quality of life).~   "
148298|NCT01625351|"~     This is a phase I study designed to determine the feasibility of transplantation using a~     novel transplant approach that employs a two-stage haploidentical cell infusion following~     myeloablative conditioning. This strategy, which includes selective depletion of naïve T~     cells, may speed immune reconstitution thereby potentially reducing the limitations of~     traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its~     potential therapeutic application. Additionally, the investigators intend to explore overall~     survival, event-free survival, hematopoietic cell recovery and engraftment as well as~     infection rates and complications in these patients.~   "
148299|NCT01625338|"~     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)~     in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults~     with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study~     and have not achieved sustained virologic response (SVR).~   "
148300|NCT01625325|"~     While obese and extremely obese youth are at increased risk of health complications,~     especially the extremely obese group rarely seek medical care. One of the underlying reasons~     might be the lack of adequate treatment options. This study is a subproject of the Medical~     and psychosocial implications of adolescent extreme obesity - acceptance and effects of~     structured care study, short: Youth with Extreme obesity Study (YES), which aims at~     improving the medical care and social support structures for youth with obesity and extreme~     obesity in Germany. In this subproject, information on the causes and consequences of extreme~     obesity will be gathered via questionnaires and medical examinations.~      Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially~     up to 21 years) are eligible to participate. Participants will be asked to complete a series~     of questionnaires on their general health, psychosocial situation and wellbeing in 2-3~     sessions. They will be offered a thorough medical examination comprising a general check-up,~     a fasting blood draw and oral glucose tolerance test, a focused orthopaedic examination, a~     sleep apnea screening, and an ultrasound of the liver. The aim of the study is to elicit the~     acceptance of diagnostic and therapeutic procedures, and to assess the frequency of~     co-morbidities in obese and extremely obese youth. This knowledge will optimize medical~     treatment and support options. Interested participants will be invited to participate in~     further steps of YES, which entail medical care and psycho-social support.~   "
148301|NCT01625312|"~     Coronary heart disease (CHD) pose a serious health threaten to population. Optimal~     revascularization strategy in multiple vessel coronary artery disease patients remains a~     subject of debate between interventional cardiologists and surgeons. Knowledge about the~     real-life revascularization pattern and outcomes in China is limited. By consecutively~     recruiting three vessel coronary heart disease patients in 25 geographically representative~     highest-rank hospitals, this study will examine revascularization strategy, and various~     real-life factors, that may affect patients lone-term recovery. Practical guidelines,~     appropriateness criteria and quality evaluative system for revascularization strategy will be~     established based on the findings, to improve patients outcomes in future finally.~   "
148302|NCT01625299|"~     We hypothesize that in children with autism dietary antigens can change the intestine, making~     it leaky and then affecting the brain changing their behavior.~   "
148303|NCT01625286|"~     The purpose of this study is to investigate the safety and efficacy of different doses and~     schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with~     advanced or metastatic breast cancer. Also to investigate a selected dose and schedule of~     AZD5363 in combination with paclitaxel vs. paclitaxel in combination with placebo in~     treatment of patients with estrogen receptor-positive advanced or metastatic breast cancer,~     including a subgroup who have the phosphoinositide-3-kinase, catalytic, alpha polypeptide~     (PIK3CA) tumour mutation.~   "
148304|NCT01625273|"~     The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant~     formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.~   "
148305|NCT01625260|"~     This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801~     combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing~     or intolerant), non-muscle invasive bladder cancer and refuse or are not medically fit to~     undergo a radical cystectomy recommended by the participating urologist as the standard next~     therapy per urologic guidelines. The purpose of this study is to confirm the safety and~     tolerability of a well-tolerated dose level of ALT-801, to determine the Recommended Dose~     level (RD) and characterize the immunogenicity of ALT-801 combined with gemcitabine in~     treated patients. The anti-tumor responses will also be assessed.~   "
148306|NCT01625247|"~     Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The~     role of routine drainage after LC to decrease postoperative morbidity is still an issue of~     considerable debate. The goal of this study was to assess to role of drains in LC, performed~     for acute inflamed gallbladder.~   "
149241|NCT01612988|"~     ICLL01 The BOMP trial: Phase II study of salvage treatment with Bendamustine, Ofatumumab and~     MethylPrednisolone (BOMP) in relapsed B-cell chronic lymphocytic leukemia (B-CLL).~      A study of the GOELAMS / GCFLLC-MW intergroup~   "
148309|NCT01625208|"~     This study will examine how successfully nerves are blocked or frozen for hand surgery.~     Traditionally, the nerves are frozen at the base of the neck, just above the clavicle or~     collarbone (the supraclavicular block). This is mostly successful by itself, and provides~     anesthesia of the entire arm. Occasionally, an additional nerve block is required further~     down the arm, as the supraclavicular block may have missed a segment, or it is taking too~     long to come on. In this study the investigators will compare the traditional technique, with~     a similar but lower volume supraclavicular block plus an immediate low volume block of one~     nerve further down the arm (the ulnar or median nerve block, depending on which digits are~     being operated on). The investigators will compare success rates, speed of onset, procedural~     comfort and length of time of weakness and numbness, plus any adverse events.~   "
148310|NCT01625195|"~     Nutrition is key to healthy aging for a number of diseases but the investigators have~     reported imbalances in the distribution of long chain omega-3 fatty acids (LC-omega-3) in the~     elderly and in the carriers of apolipoprotein E epsilon 4 (APOE4) isoform. Carrying APOE4~     isoform is currently recognized as being the most important genetic risk factor of cognitive~     decline. The investigators believe that dysregulation of LC-omega-3 metabolism is intimately~     link with higher risk of cognitive decline. The current project will investigate whether~     there is a causal relationship between LC-omega-3-enriched diet and cognition using, on the~     one hand, a randomized double-blind placebo-controlled design and on the other hand,~     transgenic mice carrying human APOE4. In both study, the investigators will focus~     specifically on the distribution (level) of LC-omega-3 into lipoproteins with age and/or~     APOE4 isoform to evaluate whether dysfunctional transport of LC-omega-3 is associated with~     lower cognitive scores on visuospatial capacity, verbal fluency or working memory. In APOE4~     mice, the investigators will evaluate LC-omega-3 brain uptake together with the level of~     LC-omega-3 in the brain membranes and the level of APOE protein within the brain. The present~     investigation will provide key basis for understanding how to develop nutritional strategies~     for healthy aging and the preservation of cognitive function.~   "
148311|NCT01625182|"~     The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of~     chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.~   "
148312|NCT01625169|"~     HIV positive pregnant women who receive potent combination antiretroviral therapy over at~     least the last trimester of pregnancy, and who have proper obstetric interventions and are~     able to avoid breast feeding, decrease the risk of having an infected infant to about 1%.~     Breast milk HIV-1 RNA (cell free) viral load is significantly associated with breast milk~     transmission, and a 2-fold increased risk of transmission associated with every 10-fold~     increase in breast milk viral load has been reported. In addition, cell associated virus (HIV~     DNA) was associated with a significant increase in risk of transmission independent of the~     level of cell-free viral RNA.~      However, multiple studies of HIV positive women giving birth have shown that exclusive~     breast-feeding carries a much lower risk of HIV transmission than mixed breast-feeding~     (defined as breast milk along with complementary food, other milk, and/or infant formula).~     The proposed study will measure the antiretroviral (ARV) drug etravirine concentrations in~     blood and breast milk in postpartum HIV positive women on HAART therapy. The short-term goal~     is to determine how much etravirine penetrates into breast milk, and whether it leads to~     undetectable HIV viral load in the breast milk and therefore has the potential to decrease~     the risk of transmission of HIV through breast milk. The long term goal is to see if breast~     milk HIV levels can be lowered sufficiently to prevent maternal to child transmission (MTCT)~     of HIV in infants receiving only breast feeding in resource poor areas.~   "
148313|NCT01625156|"~     This phase I trial studies the side effects and best dose of tivantinib when given in~     combination with temsirolimus in treating patients with solid tumors that have spread to~     other parts of the body or cannot be removed by surgery. Tivantinib and temsirolimus may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
148314|NCT01625143|"~     This laboratory study is looking into genes in samples from younger patients with relapsed~     acute lymphoblastic leukemia. Studying samples of tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat cancer.~   "
148315|NCT01625130|"~     Purpose: To determine if modulation of NRF2 with a Sulforaphane enriched supplement modifies~     responses to O3. Participants: Recruitment of up to 70 healthy volunteers, ages 18-50, for~     completion of 36 volunteers. Procedures: This is a randomized, placebo controlled 2x2~     crossover study of treatment with an NRF2 modifier versus placebo in healthy volunteers which~     will examine airway inflammation before and 4 hours after a 2 hour 0.4 ppm O3 exposure.~     Participants will be randomized to received either the NRF2 modifier, SFN oral supplement~     (i.e. broccoli sprout shake), or placebo (alfalfa shake) for 3 days followed by a 0.4 ppm O3~     exposure for 2 hours. At least 2 weeks later subjects will return for a 2nd supplementation~     treatment (using the alternative supplement to that provided initially) followed by an ozone~     exposure identical to the initial one.~   "
148316|NCT01625117|"~     The purpose of this study is examine, whether a treatment approach, which is specifically~     tailored for perpetrators who have participated in violence (a variant of Narrative Exposure~     Therapy) is effective in the reduction of instrumental aggression and symptoms of~     posttraumatic stress disorder.~   "
148317|NCT01625104|"~     The primary objective of this study is to assess whether an aggressive quality improvement~     intervention strategy will decrease time from hospital presentation to first balloon~     inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with~     primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were~     randomized to either aggressive intervention or control. The intervention consisted of Grand~     Rounds at each hospital, sharing of best practices, and coordinating center staff working~     closely with staff at each intervention hospital to discuss solutions to barriers to rapid~     treatment for STEMI patients.~   "
148380|NCT01624285|"~     The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and~     effective treatment option for preventing liver cancer in high risk patients following liver~     transplantation. Liver transplantation is a treatment option for liver cancer patients, but~     despite transplantation, the liver cancer can recur in the new, transplanted liver. It is not~     known whether sorafenib is effective in preventing cancer recurrence in high risk patients~     following liver transplantation~   "
148318|NCT01625091|"~     The primary objective of this study is to evaluate whether an intervention that involves the~     medication naltrexone, will reduce drinking and improve health outcomes in women with HIV~     infection and hazardous drinking. Our central hypotheses are that, compared to women who~     receive placebo (sugar pill containing no medicine), women who receive naltrexone will have~     decreased rates of hazardous drinking, improved HIV medication adherence, less rapid disease~     progression, and reduced sexual risk behavior. The study design will involve 240 HIV-infected~     women with hazardous drinking, who will be recruited from HIV clinics, neighborhoods and~     referrals in Miami, Florida.~      Eligible women will receive either a daily pill containing naltrexone (50mg) or an~     identical-appearing placebo for four months. All participants will receive encouragement and~     feedback related to their drinking regardless of medication assignment. The study~     participants will be assessed at two, four and seven months after enrollment. The proposed~     work is innovative because pharmacologic treatment for alcohol has not been evaluated in~     HIV-infected women. If our hypotheses are confirmed, the study findings would transform the~     approach to hazardous drinking within clinics serving HIV-infected women.~   "
148319|NCT01625078|"~     The investigators wish to accumulate initial data on the performance and safety of the Baska~     mask in paediatric patient population.~   "
148320|NCT01625065|"~     In this study medication compliance regarding current drug use is investigated using~     toxicological analyzes in two patient groups: patients from a pain management department and~     pre-surgical control patients. The aim is to explore the incidence of concealed and feigned~     substances and to determine the respective substance classes. Expecting that noncompliance is~     higher in the pain patient group, the investigators want to identify clinical risk factors~     for noncompliant drug report.~   "
148321|NCT01625052|"~     The investigators group has performed a number of studies on novel airway devices, including~     an observational study on the performance of a new supraglottic airway named Baska mask. In~     this new study the investigators wish to determine which criteria best predict the correct~     size of the Baska mask to be used in male patients~   "
148322|NCT01625039|"~     The introduction of a wellness programme for workers employed in a clothing factory will~     improve quality of life, pain, attendance at work and levels of physical activity.~   "
148323|NCT01625026|"~     By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but~     presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in~     laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high~     affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and~     glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively,~     that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone (GS)~     surgery where in addition to blood samples also biopsies are taken from the liver and in the~     case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder bile.~   "
148324|NCT01625013|"~     This study aims to study use of viscosupplementation as a treatment of pain for young~     individuals who are active. Typically viscosupplementation is considered an intervention for~     knee osteoarthritis often for older patients who are less active. Many young active patients~     can also develop knee osteoarthritis after trauma or surgery or for congenital reasons.~     Treatment of these patients commonly are steroid injections which have more biologically~     detrimental effects for cartilage compared to viscosupplementation Synvisc One injections~     which are a single injection will be used to determine effectiveness of reducing pain and~     maintaining an active healthy lifestyle for younger patients aged 30-50 years old.~   "
148325|NCT01625000|"~     The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214~     relative to placebo in patients with acute exacerbation of schizophrenia.~   "
148326|NCT01624987|"~     The project aims to investigate if trauma-related disorders and appetitive aggression can be~     reduced in former ex-combatants in DR Congo when a specific intervention (Narrative Exposure~     Therapy for Forensic Offender Rehabilitation, FORNET) is delivered by trained local personnel~     (phase 1). In a second step, the project aims to investigates the treatment success if this~     specific therapy is carried out by local personnel who have been trained by other local~     personnel (train the trainer, phase 2) under the supervision of experts of the University~     of Konstanz.~   "
148327|NCT01624974|"~     The purpose of this study is to evaluate the effect of MK-1029 on lung function in the~     treatment of adults who have persistent asthma that is uncontrolled with the use of~     montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for~     two separate 4-week treatment periods. All participants will also use ML during the treatment~     periods.~   "
148328|NCT01624961|"~     The study is designed to establish the best dose to safely infect healthy individuals with~     Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) injection.~   "
148329|NCT01624948|"~     This study is examining the safety and efficacy of converting anti-rejection therapy from~     mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus~     infection.~      The study will also determine if immune monitoring tests can detect an association between BK~     virus infection and transplant rejection episodes, based on the specific BKV infection~     treatment regimen.~      The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and~     tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and~     tacrolimus + prednisone in patients who have undergone renal transplantation and have active~     BKV infections.~   "
148421|NCT01623739|"~     The investigators are asking subjects to take part in a research study of soft tissue (gums)~     and bone (jawbone) healing around dental implants following tooth extraction. The~     investigators want to compare how the gums and the bone changes shape with healing in two~     different scenarios:~        1. When the implant is placed at the same time the tooth is extracted.~        2. When the tooth is extracted and then left to heal for a period of 4 to 8 weeks before~          the implant is placed.~      Previous studies have shown that both methods work and can give good results. In fact the two~     methods are used routinely as part of standard care but it is not known if the two procedures~     are equally good since they have never been compared in one same research study.~   "
149037|NCT01615679|"~     Non-interventional study to gain further information about the therapy progression in routine~     treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus will be~     on the improvement of the clinical global impression (CGI) in comparison to the outcome of~     randomized, controlled studies.~   "
148330|NCT01624935|"~     The enormous global burden of mental illness has been estimated through the publication of~     the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma~     such as natural disaster bear a particularly high burden of mental disorders, with depression~     and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric~     diagnoses. In traumatized populations, these disorders do not remit with replacement of~     material losses or resettlement to safe locations, but rather tend to become chronic~     conditions with attendant disability. PTSD and depression are risk factors for anger,~     interpersonal discord and violence, not only among those who have trauma and depression, but~     also among their spouses and children. This infectious model of trauma/violence is~     critically important in the setting of natural disaster, as increased levels of interpersonal~     violence within the afflicted community hinder its recovery. To date, there has been little~     research on the interpersonal effects of mass trauma. The proposed research is a randomized~     controlled trial of Interpersonal Therapy (IPT) versus wait list control (WLC) for~     survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy~     for depression, has been adapted for PTSD treatment and developing country settings. Measures~     will evaluate success of the treatment not only in terms of individual depression and PTSD~     symptoms, but also with respect to interpersonal functioning.~      Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet~     criteria for Depression and PTSD at the conclusion of the RCT.~      Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning~     than wait list controls.~   "
148331|NCT01624922|"~     Coronary heart disease (CHD) pose a serious health threaten to population. PCI, as a~     well-proved and booming measure in CHD management, is invasive and of high cost, however the~     knowledge about the real-life PCI use in China is limited. By consecutively recruiting PCI~     patients in 30 geographically representative highest-rank hospitals, this study will examine~     various real-life factors, that may affect patients recovery after the procedure. Practical~     guidelines, appropriateness criteria and quality evaluative system for PCI will be~     established based on the findings, to improve patients outcomes in future finally.~   "
148332|NCT01624909|"~     Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women,~     however little information is available about how evidence-based therapies are incorporated~     appropriately into routine clinical practice in China. In addition, basic data and evidence~     about safety and efficacy of treatment for AMI is limited. By consecutively recruiting AMI~     patients in 40 hospitals of different levels, this study will examine various real-life~     factors, that may affect patients recovery after a heart attack. Practical guidelines and~     risk model for AMI patients will be established based on the findings, to improve patients~     outcomes in future finally.~   "
148333|NCT01624896|"~     Coronary heart disease (CHD) is one of the leading causes of mortality and morbidity. PCI, as~     a well-proved and booming measure in CHD management, is invasive and of high cost, however~     the knowledge about the real-life PCI use in China is limited. Within a nation-wide and~     regional representative probability sample of hospitals in China, 14,000 CAG/PCI inpatient~     cases will be sampled randomly from 2001 to 2011. The sampled medical records will be~     reviewed and abstracted in the national coordinating centre, in order to evaluate the~     treatment pattern, outcomes, and cost for PCI, during the past decade. Basic data and~     innovative evidence will accelerate evidence-based clinical practice and policy making, and~     improve patients outcomes in future finally.~   "
148334|NCT01624883|"~     Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women,~     however the knowledge about the real-life AMI management in China is limited. Within a~     nation-wide and regional representative probability sample of hospitals in China, 27,800 AMI~     inpatient cases will be sampled randomly from 2001 to 2011. The sampled medical records will~     be reviewed and abstracted in the national coordinating centre, in order to evaluate the~     treatment pattern, outcomes, and cost for AMI patients, during the past decade. Basic data~     and innovative evidence will accelerate evidence-based clinical practice and policy making,~     and improve AMI patients outcomes finally.~   "
148335|NCT01624870|"~     The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with~     the Medtronic CoreValve bioprosthesis.~   "
148336|NCT01624857|"~     Depression is frequently observed in patients with coronary heart disease (CHD) and~     represents a significant risk factor for major cardiovascular events. Previous study has~     proved that high sensitive C-reactive protein (hsCRP) was an independent predictor for~     depression in CABG patients at 6 months after bypass surgery. Statins can effectively reduce~     the blood levels of hsCRP. This study aim to examine whether statins can improve the~     prognosis of depressive patients undergoing coronary artery bypass surgery through reducing~     the levels of hsCRP.~   "
148337|NCT01624844|"~     The purpose of this study is to investigate whether the dural sac volume as determined by a~     geometrical calculation following multilevel measurements of its transverse area and length~     by ultrasound imaging, correlates with the intrathecal spread of a single dose of hyperbaric~     bupivacaine in a non-obstetrical population.~   "
148338|NCT01624831|"~     In the current study, the investigators propose to measure the five domains of social~     cognition identified by the National Institute of Mental Health (NIMH) as relevant to~     individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition,~     social perception, and social knowledge). The investigators will also explore the association~     between different domains of social cognition and outcomes relevant to psychotic disorder~     (e.g., symptomatology, social functioning, and vocational functioning).~   "
148422|NCT01623726|"~     The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as~     complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized~     into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main outcome will~     be measured by specific clinical rating scales based on the assessment of negative symptoms.~     A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes~     shall include collateral effects evaluation, anxiety and depressive scales as well as~     clinical monitoring.~   "
148423|NCT01623713|"~     The purpose of this study is to determine whether iloperidone is effective in the treatment~     of Schizophrenia.~   "
149094|NCT01614912|"~     The study evaluates the long term safety and efficacy of SM-13496 in patients with~     schizophrenia.~   "
149095|NCT01614899|"~     The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients~     with schizophrenia.~   "
148339|NCT01624818|"~     Background: In Norway each year 130-150 children are born with heart disease that requires~     lifelong medical follow-up. Children with heart defects have reduced motor skills and reduced~     physical capacity compared with healthy peers. Increased knowledge in the children themselves~     and the general public, along with psychosocial interventions improve the child's ability to~     cope with the consequences of their disease. Descriptions of the experiences that Norwegian~     children with heart disease and their parents have about participation in rehabilitation~     programs is limited. Geilomo children's hospital has 75 years experience in rehabilitation of~     children with chronic illness, and started in 2005 to welcome children with heart disease. At~     present there is no rehabilitation institutions in Norway that has a special group programs~     for children with heart disease. Geilomo want to establish such a group for children aged 6-7~     years and 11-12 years.~      Main objective: The investigators will use of methods to learn more about the following:~      Study 1: The purpose is to generate knowledge about how children with heart disease and their~     relatives experience participation in a rehabilitation program at Geilomo children's~     hospital.~      Overarching question: How do children with heart disease and their guardians to participate~     in a rehabilitation program, and the impact of this on their daily life afterwards?~      Study 2: The purpose is to help a) to give the children an increased level of activity in the~     home environment.~      Question: Will children with heart disease increase their activity levels at home after a~     stay at Geilomo? 2b) for the children to improve their physical fitness. Question: Will~     children with heart disease have improved their physical condition three months after a stay~     at Geilomo?~      Work schedule: The project will have a duration of 3 years. The project will seek approval of~     the Regional Committee for Medical Research Ethics in May 2012. Interview Guide, information~     sheet and consent form has been prepared. Data collection for the study 2AB can start in~     March 2013. The first interviews will be conducted after 3 months, in June 2013. Data~     collection is expected to be completed in December 2013. The analysis will take place in~     parallel with the interview work. In 2014 and 2015 completed the writing of articles (3~     pieces) and publication of results.~      Method: In order to shed light on the problem in study 1, the investigators will use~     semi-structured interview. 16 children and 16 parents to be interviewed after 3 months. Study~     2a) To get information about their child's activity level in the home environment the~     investigators will use structured questionnaires. It is one form for children (36 persons)~     and another form for their parents (36 persons). Study 2b) All children (36 persons)~     conducting physical fitness test at the first visit and after three months. Children can be~     referred from across the country via the referral form. Dr. Henrik Holm (OUS) and Dr. Asle~     Hirth (HUS) determines participation according to inclusion and exclusion criteria.~      Parents submit a written consent on behalf of themselves and their children.~      Scientific significance: This application describes two related studies, both of which are~     expected to provide important information that can provide better services for children with~     heart disease.~   "
148340|NCT01624805|"~     You are being asked to take part in this study because you have aplastic anemia (AA) or~     low/int-1 risk myelodysplastic syndrome (MDS).~      The goal of this clinical research study is to learn if horse anti-thymocyte globulin (hATG),~     given in combination with methylprednisolone, cyclosporine, and G-CSF (filgrastim or~     pegfilgrastim), can help to control AA and/or low-int-1 risk MDS. The safety of this drug~     combination will also be studied.~      hATG is made from horse blood and targets immune cells known as T-lymphocytes. Since~     T-lymphocytes are believed to be involved in causing low blood counts in AA and in some cases~     of MDS, killing these cells may help treat the disease.~      Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This~     may help to improve low blood counts in AA and in some cases of MDS.~      Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help~     to fight infections and help improve the white blood cell count.~      This is an investigational study. hATG, cyclosporine, methylprednisolone, and~     filgrastim/pegfilgrastim are all FDA approved and commercially available for use in patients~     with AA and MDS. The use of filgrastim/pegfilgrastim with this drug combination is~     investigational.~      Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.~   "
148341|NCT01624792|"~     Loss of muscle protein is generally a central component of weight loss in Chronic Obstructive~     Pulmonary Disease (COPD) patients. Gains in muscle mass are difficult to achieve in COPD~     unless specific metabolic abnormalities are targeted. The investigators recently observed~     that alterations in protein metabolism are present in normal weight COPD patients. Elevated~     levels of protein synthesis and breakdown rates were found in this COPD group indicating that~     alterations are already present before muscle wasting occurs. The investigators recently~     observed that in order to enhance protein anabolism, manipulation of the composition of~     proteins and amino acids in nutrition is required in normal-weight COPD. Intake of casein~     protein resulted into significant protein anabolism in these patients. The anabolic response~     to casein protein was even higher than after whey protein intake.~      A substantial number of COPD patients, underweight as well as normal weight to obese, is~     characterized by an increased inflammatory response. This group failed to respond to~     nutritional therapy. Previous experimental research and clinical studies in cachectic~     conditions (mostly malignancy) indicate that polyunsaturated fatty acids (PUFA) are able to~     attenuate protein degradation by improving the anabolic response to feeding and by decreasing~     the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic~     acid (DHA)) has been shown to effectively inhibit weight loss in several disease states,~     however weight and muscle mass gain was not present or minimal.~      Until now, limited research has been done examining muscle protein metabolism and the~     response to EPA and DHA supplementation in patients with COPD.~      It is the investigator's hypothesis that supplementation of 2g/day EPA+DHA in COPD patients~     during 4 consecutive weeks will increase the muscle anabolic response to a high quality~     protein supplement as compared to a placebo, and supplementation of 3.5g/day EPA+DHA will~     increase the anabolic response even further. In the present study both the acute and chronic~     effects of EPA+DHA versus a placebo on muscle and whole body protein metabolism will be~     examined. The principal endpoint will be the extent of stimulation of net fractional muscle~     protein synthesis as this is the principal mechanism by which the effect of EPA+DHA on muscle~     anabolism can be measured. The endpoint will be assessed by isotope methodology which is~     thought to be the reference method.~   "
148342|NCT01624779|"~     The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal~     stem cells in the patients with spinal cord injury, Phase I Clinical study.~   "
148343|NCT01624766|"~     You are being asked to take part in this study because you have advanced cancer that has~     either gotten worse or is resistant to standard therapy.~      The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Afinitor (everolimus) either with Kineret (anakinra) or Xgeva (denosumab) that~     can be given to patients with advanced cancer. The safety of these drugs will also be~     studied.~      Everolimus is designed to stop cells from dividing.~      Anakinra is designated to block a protein that is involved in tumor development, new blood~     vessels growing, and spread of cancer.~      Denosumab is designed to block the activity of a protein, which may prevent bone~     complications in cancer that has spread to the bone.~      This is an investigational study. Everolimus is FDA approved and commercially available to~     treat pancreatic cancer that has gotten worse, advanced renal cell carcinoma, and a type of~     brain tumor called subependymal giant cell astrocytoma. Anakinra is FDA approved and~     commercially available for treatment of rheumatoid arthritis. Denosumab is FDA approved and~     commercially available to prevent bone problems in patients with solid tumors that have~     spread to the bone. The combination of everolimus either with anakinra or denosumab to treat~     advanced cancer is investigational.~      Up to 147 patients will take part in this study. All will be enrolled at MD Anderson.~   "
148424|NCT01623700|"~     This observational study will based on the Register of Information and Knowledge About~     Swedish Heart Intensive Care Admissions (RIKS-HIA) and the Swedish Coronary Angiography and~     Angioplasty Registry (SCAAR) which since 2009 are merged into The Swedish Web-system for~     Enhancement and Development of Evidence-based care in Heart disease Evaluated According to~     Recommended Therapies (SWEDEHEART).~      The aim of this study is to investigate the impact of different antithrombotic treatment~     options (treatment duration, type of treatment and combination of treatments) in Acute~     Coronary Syndrome (ACS) patients on outcomes such as recurrent ischemic events and mortality.~   "
148425|NCT01623687|"~     What is the intensity of F-PET uptake in healthy and osteo arthritic femur and acetabulum,~     compared to the uptake adjacent to four analyzed endoprosthetic components 1½ and 6 months~     after surgery?~   "
148344|NCT01624753|"~     Fibered confocal fluorescence microscopy (FCFM) (CellvizioR Lung, MaunaKea Technologies,~     France) could potentially provide diagnostic information on fibrosis and inflammation of the~     distal air spaces associated with diffuse parenchymal lung diseases without the need for lung~     biopsies, thereby fulfilling the gap in the investigators current medical practice of a~     minimally invasive procedures with few complications and a high diagnostic fidelity.~      In patients scheduled for bronchoscopy as part of regular clinical care/diagnostic workup,~     the investigators will offer the patient concurrent FCFM imaging to be performed during the~     bronchoscopic procedure. The investigators aim to identify and catalogue distinct and~     discriminating features seen on images obtained from fibered confocal fluorescence microscopy~     in this group of patients, and to correlate these findings with specific high resolution~     computed tomography (HRCT) features and pathological findings if available. Eventually the~     investigators hope to create diagnostic criteria for fibered confocal fluorescence microscopy~     image interpretation of specific diffuse parenchymal lung disease entities.~   "
148345|NCT01624740|"~     To determine the effects of varying spinal cord stimulation programming parameters, including~     stimulation rate, on pain intensity.~   "
148346|NCT01624727|"~     The purpose of the study is to target inflammation to reduce progression of noncalcified~     plaque in the coronary arteries using omega-3 fatty acid supplementation compared to standard~     of care.~   "
148347|NCT01624714|"~     The purpose of this study is to treat prospectively documented clinic patients with~     treatment-refractory multiple sclerosis that are naïve to alemtuzumab. Alemtuzumab shows~     efficacy and rate of serious adverse events (SAEs) which is equivalent or better than~     standard of care treatment strategies used previously for treatment-refractory multiple~     sclerosis.~   "
148348|NCT01624701|"~     This is a pilot clinical trial to assess the feasibility and efficacy of expanding umbilical~     cord blood derived blood stem cells for transplantation using a combination of chemical~     factors and stromal co-culture. Bone marrow (BM) mesenchymal stromal cells (MSC) will be~     obtained from a separate bone marrow donor. One cord blood unit will be expanded by this~     method while another cord blood unit will be infused without manipulation. The expanded cord~     blood unit will help boost the initial recovery of blood counts after transplantation, though~     it is expected that the unexpanded cord blood unit will provide the cells which will lead to~     long term engraftment of blood stem cells. A third cord blood unit will be identified for~     standby should the cord blood unit expansion fail.~   "
148349|NCT01624688|"~     The purpose of this study is to combine treatment options for tattoo removal in an attempt to~     completely remove a tattoo in one visit.~   "
148350|NCT01624675|"~     The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in~     children and adolescents with irritability associated with autistic disorder.~   "
148351|NCT01624662|"~     The primary objective of this study is to compare the efficacy of intranasal administration~     of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose~     device with placebo in subjects with bilateral nasal polyposis.~   "
148352|NCT01624649|"~     The purpose of this observational study is to explore the efficacy of methylphenidate~     hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity~     disorder (ADHD) by Kiddie-scheduled for affective disorders (SADS)-present and life time~     version (K-SADS-PL).~   "
148353|NCT01624636|"~     This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and~     efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular~     age-related macular degeneration (AMD)~   "
148354|NCT01624623|"~     This study will evaluate the daily use of a unique daily organ tracking system on target~     localization in patients treated with radiation therapy after radical prostatectomy for~     prostate cancer.~      Improved coverage of the target volume with radiotherapy could result in improved cancer~     control rates and decreased coverage of surrounding structures potentially decreasing~     treatment toxicity.~   "
148355|NCT01624610|"~     The purpose of the study is to find out if the diets often recommended for patients with~     Irritable Bowel Syndrome with diarrhea (IBS-D) provide adequate relief. The study will~     compare two diets that are used to treat IBS-D symptoms to see which one is more effective.~     The study will also measure the effect of these diets on the bowel flora, which are the good~     bacteria that inhabit the bowels in healthy people.~   "
148356|NCT01624597|"~     This randomized controlled trial will evaluate an intervention that provides parents with~     objective feedback about their teen's driving as well as strategies to improve communication~     with their teen about driving. We will recruit 180 newly-licensed teen drivers and a parent~     or guardian. Our main hypotheses are that: parent-teen dyads who receive feedback will have~     reduced driving errors and increased safety behaviors than dyads with no feedback; and,~     parent-teen dyads who receive instruction on communication techniques will have improved~     quality and quantity of communication about driving than dyads not learning these techniques.~   "
148357|NCT01624584|"~     First, can exposure therapy for childhood anxiety begin earlier in the course of treatment~     than current treatment manuals suggest?~      Second, is treating childhood anxiety with exposure therapy more effective and efficient than~     treating childhood anxiety with relaxation training + cognitive restructuring?~   "
148358|NCT01624571|"~     This clinical trial is conducted to determine the optimal dose of LD02GIFRO in improvement of~     gastrointestinal motility between each dose group by comparing the effectiveness and safety~     in patients undergoing colon resection.~   "
148426|NCT01623674|"~     The aim of the study was to asses the effect of sleep deprivation during nightshift by~     monitoring 30 surgeons in unit of surgical gastroenterology in 4 consecutive days. The first~     day was pre call= day 1, second day was on call= day 2, third day was the first post call day~     = day 3 and fourth day was the second post call= day 4. The surgeons were monitored in order~     to asses how performance was on call compared to pre call and post call. The hypothesis was~     that they would perform worse on call than pre call, and again slightly worse post call.~   "
148427|NCT01623661|"~     Patients with chronic kidney disease (CKD) have a defect in the tubular reabsorption of~     sodium, and therefore the ability to excrete a sodium load is diminished compared to healthy~     subjects.~      Urinary biomarkers reflects the water- and sodium-channel activity in the kidney and may be~     measured after an infusion with hypertonic saline in CKD patients and healthy subjects.~   "
148359|NCT01624558|"~     Malignant hyperthermia is a potentially fatal inherited disorder triggered by exposure to~     volatile anesthetic gases, most commonly recognized in children during anesthesia. Carbon~     filters have been used to scavenge various gases. A new carbon filter (Vapor Clean,~     Dynasthetics, LLC, Salt Lake City, Utah) with a 510(k) clearance specifically for scavenging~     anesthetic gases is being marketed, though the filter itself has never been studied in vivo.~     Bench studies conducted by the manufacturer of the product demonstrate it is extremely~     effective in reducing the volatile gas output from an anesthesia machine within 2 minutes.~     This pilot study will measure the effect on volatile gas concentration in non-malignant~     hyperthermia susceptible patients. Twelve (12) patients will undergo standard anesthetic~     induction using inhalational anesthetic (Sevoflurane®) and maintained on 3% for 30 minutes to~     attain steady state concentrations.1 At that time, a total intravenous anesthetic technique~     will be started and maintained throughout the case. Simultaneously a Vapor Clean filterset~     will be placed in the breathing circuit (inspiratory and expiratory limbs). Volatile gas~     concentration will be measured and recorded. This research will determine the feasibility of~     using this carbon filter to quickly reduce the breathing circuit gas concentration of~     volatile anesthetic in the clinical setting. This is fundamental in establishing this as a~     key life saving measure in eliminating the stimulus in a malignant hyperthermia event.~   "
148360|NCT01624545|"~     Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These~     hematomas develop after minor head trauma and increase in size over weeks. Patients usually~     present with headaches, gait disturbances, language problems or confusion. The state of the~     art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr~     hole trepanation.~      The optimal follow-up for operated patients remains controversial. Due to the known high rate~     of a second hematoma at the same place (usually within weeks), one strategy is to perform~     serial computer tomography scans in order to identify recurrent hematomas early. The~     radiologic evidence of a second hematoma often leads to reoperation, even if the patient has~     no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to~     closely follow the patient with neurological examinations and perform neuroimaging only in~     case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT~     scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a~     patient population marked by advanced age and fragility.~      The aim of the current study is to evaluate the role of computer tomography scanning in the~     postoperative follow-up after removal of a chronic subdural hematoma. Participants of this~     study will be allocated by chance to one of two study groups: Patients allocated to group A~     will receive a computer tomography scan on day 2 and again on day 30 after surgery in~     addition to a clinical examination. Patients allocated to group B will be examined clinically~     on day 2 and day 30 without computer tomography. All patients will undergo a final clinical~     examination after 6 months. The study will recruit 400 patients.~   "
148361|NCT01624532|"~     The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the~     Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.~   "
148362|NCT01624519|"~     The main objective of this study is to examine the agreement between arterial, central~     venous, and peripheral venous lactate values in a population of medical Intensive Care Unit~     (ICU) patients.~   "
148363|NCT01624506|"~     The Anti-Reflux Surgical Study has been established to:~        -  Collect data about anti-reflux surgical treatment options (magnetic sphincter~          augmentation and Fundoplication) in everyday clinical practice~        -  Track the clinical course of patients from pre-operative assessment to three years~          post-surgery~   "
148364|NCT01624493|"~     This phase I/II trial will determine the recommended dose and activity of BNC105P for~     patients with partially platinum sensitive ovarian cancer in first or second relapse.~   "
148365|NCT01624480|"~     This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and~     multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with~     excessive sleepiness associated with narcolepsy.~   "
148366|NCT01624467|"~     The purpose of this study is to determine whether treatment with necitumumab monotherapy~     affects the QT/QTc interval among participants with advanced solid tumors refractory to~     standard treatment or for which no standard treatment is available.~   "
148367|NCT01624454|"~     Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel~     cleansing, randomizing adult outpatients by invitation letter~   "
148368|NCT01624441|"~     This phase I clinical trial studies the side effects and the best dose of dinaciclib when~     given together with epirubicin hydrochloride (epirubicin) in patients with metastatic (cancer~     that has spread to other parts of the body) triple-negative breast cancer. Dinaciclib is~     designed to stop cancer cells from dividing into new cancer cells. Epirubicin is designed to~     block the way cancer cells grow and divide and may slow or stop cancer cells from spreading~     throughout the body. Researchers want to find out what is the highest tolerable dose of the~     experimental drug dinaciclib that can be given in combination with epirubicin in patients~     with metastatic triple negative breast cancer.~   "
148369|NCT01624428|"~     This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the~     influence of varenicline on reward processing, cognitive control, and regulation of craving~     in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when~     compared with those receiving placebo, will have differential brain responses to anticipation~     of rewards, during exposure to the Stroop task, and in response to tobacco cues.~   "
148428|NCT01623648|"~     The investigators hypothesis is that eating whey protein in the breakfast versus other~     proteins will results in higher satiety, reduced overall postprandial glycemia and more~     weight loss in obese diabetic individuals~   "
148458|NCT01623258|"~     The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node~     metastasis with sentinel lymph node (SLN) mapping.~      Null hypothesis: There is no difference in the rate of lymph node metastasis between~     conventional histopathological processing of lymph nodes and SLN mapping with detailed~     pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of~     colon carcinoma.~   "
149096|NCT01614886|"~     To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration~     of Rivastigmine patch in the Japanese population.~   "
185525|NCT01136226|"~     The purpose of this study is to determine if testosterone will recover to 90% by year 1 after~     using Eligard.~   "
148370|NCT01624415|"~     Humans attain binocular vision from the two retinal images of both eyes through a series of~     sensory and motor processes that culminate in the perception of stereoscopic depth. Looking~     at a scene creates two slightly different images on the retinas which is due to the eyes'~     different positions on the head. This so called binocular disparity provides information to~     calculate depth and therefore enables stereopsis. Physiologically the two retinal images are~     superimposed and merge into one stereoscopic image.~      If one image is presented to one eye in an experimental setting, and a completely different~     image is presented to the other eye, the investigators visual system, analogous to diplopic~     vision, is not able to fuse these image stimuli. Instead, a phenomenon called binocular~     rivalry occurs. Here, both images are seen alternating and the brain can switch back and~     forth between these images.~      The aim of the present study is to investigate the effects of objective changes to image~     quality on the investigators subjective stereoscopic perception. This psychophysiological~     testing is done by looking at different images and thereafter by subjective grading of the~     image quality.~      The investigators hypothesize that overlapping image modifications occurring in both eyes are~     detected immediately, but changes, that are rotated by 90 degrees against each other, should~     be suppressed and result in one stereoscopic image, reduced in image quality. Whether this~     also accounts for more detailed images, such as reading cards, is questionable.~   "
148371|NCT01624402|"~     Older adults who are stroke survivors can experience many challenges, including depression,~     cognitive dysfunction, and physical disability. Family members and other caregivers may~     struggle with helping stroke survivors adjust to life after stroke. This research study~     involves testing a modified form of problem-solving therapy called Ecosystem Focused Therapy~     (EFT) to help treat depression in older adult stroke survivors. EFT teaches problem-solving~     skills to patients to help them cope with problems related to stroke and depression, alters~     their physical environment to accommodate new needs resulting from stroke, and helps the~     family or caregiver to assist in the patient's adaptation. In addition this study will~     compare EFT to an education intervention to see which is more effective in treating depressed~     stroke survivors.~   "
148372|NCT01624389|"~     Alzheimer's disease (AD) may be one of the most pressing problems facing all countries around~     the world as the population ages.AD is a slowly evolving process that likes begins years to~     decades before the clinical symptoms area manifest. However, as one would like to identify~     the disease process at an earlier point in the clinical continuum, the precision of the~     diagnosis is reduced. Therefore, the challenge is to try to identify the process at the~     pre-dementia stage and enhance the specificity of the clinical diagnosis through the use of~     imaging and other biomarkers. Mild cognitive impairment (MCI) represents an attempt to~     characterize subjects at an early clinical phase of AD and subjects with MCI have been a~     target for prevention trials. There are two pathological landmarks, in terms of~     extra-cellular senile plaques and intracellular neurofibrillary tangles. Although present~     symptomatic treatments provide some benefit to patients with AD, they are not the solution~     for AD. Up to date, there are still no therapies can alter the underlying nature of the AD~     process. Therefore, the earlier the intervention takes place, presumably, the greater the~     protection against further neuronal damage will be appreciated.The Alzheimer's Disease~     Neuroimaging Initiate (ADNI) is a consortium of universities and medical centers in the~     United States and Canada established to develop standardized imaging techniques and~     biomarkers procedures in normal subjects, subjects with MCI and subjects with mild AD. ADNI~     has been a groundbreaking project, establishing pre-competitive collaboration and real-time~     data sharing among academia and industry investigators to clarify the relationships among~     demographic, genetic, clinical, cognitive, neuroimaging and biochemical measures throughout~     the course of AD neurobiology, in order to facilitate the development of effective~     therapeutics.This project has exceeded expectations, providing insights into disease~     mechanisms as well as hugely valuable advances, based primarily on the use of standardized~     biomarkers, to drug development programs. A number of the leading disease-modifying drug~     development programs are now employing ADNI methodology toward more efficient trial design,~     particularly in the critically important early (pre-dementia) AD population~   "
148373|NCT01624376|"~     The primary objective of this study is to investigate the safety and tolerability of locally~     administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.~      The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period~     and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after~     the last study visit.~   "
148374|NCT01624363|"~     The investigators are interested in performing a detailed examination of the pancreas via EUS~     (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The hypothesis~     is to make a statistical determination of how many pancreatic cysts the investigators~     discover incidentally.~   "
148375|NCT01624350|"~     This will be a prospective, multi-center, post-market, single arm observational study to~     collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of~     anorectal fistulas.~      The subjects will have baseline and day of surgery visits performed, and then subjects will~     return to the investigator for evaluation of defect and safety related morbidities at follow~     up visits scheduled at 1 month, 3 months, 6 months and 12 months post-surgery.~   "
148376|NCT01624337|"~     Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.~   "
148377|NCT01624324|"~     The aim of this study is to determine whether the plasma concentration of aminoglycoside in~     Indonesia neonates with infection are within safe and effective range and its association~     with cochlear toxicity and nephrotoxicity.~   "
148378|NCT01624311|"~     This is a pilot study which will test the safety and feasibility of hypothermia treatment as~     adjunct therapy to conventional treatment of hyperammonemic encephalopathy (HAE) in neonates~     versus conventional treatment (dialysis, nutritional therapy, and ammonia scavenging drugs)~     only. The endpoint of the pilot study will be reached when either 24 patients have been~     enrolled and no serious adverse events were observed, when no patient has been enrolled in 5~     years, or when serious adverse events occur which are clearly linked to the use of~     hypothermia. These would be serious complications not seen in patients on conventional~     therapy (dialysis , nutritional therapy, ammonia scavenging drugs) for HAE.~   "
148379|NCT01624298|"~     The purpose of this study is to study the effectiveness of Trauma Focused Cognitive~     Behavioral Therapy in subset of children who are affected by trauma with significant mental~     health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the~     severity of mental health symptoms experienced by traumatized children and adolescents in~     Lusaka and 2) determine the effectiveness of TF-CBT in reducing HIV risk taking behaviors and~     increasing coping strategies and health promotion activities in traumatized children and~     adolescents in Lusaka. The study will be integrated into current programing of the Serenity~     Harm Reduction Programme, a community and faith based organization focusing on mental health~     and substance use prevention and treatment, and its partners in 5 compounds.~   "
187207|NCT01114139|"~     To evaluate the efficacy and safety of IV ferumoxytol compared with placebo for the treatment~     of iron deficiency anemia (IDA).~   "
148381|NCT01624272|"~     The global loss of muscle mass and strength associated with aging is a cause of functional~     impairment and disability, particularly in the frail elderly. Respiratory function can be~     severely compromised if there is a decrease of respiratory (RM) strength complicated by the~     presence of comorbidities and physical immobility.~      Previous studies have shown that the specific RM training is an effective method to increase~     RM strength, both in healthy people and patients. In this case, specific RM training may be~     regarded as a beneficial alternative to improve RM function, and thus prevent physical and~     clinical deterioration in this population.~      The hypothesis is that specific RM training would improve RM strength and endurance in the~     experimental groups vs. control who do not participate in RM training.~      Institutionalized elderly people with an inability to walk were randomly allocated to a~     control group, a Threshold group or a Pranayama group. Both experimental groups performed a~     supervised RM training, five days a week for six consecutive weeks. The maximum inspiratory~     and expiratory pressures (MIP and MEP) and the maximum voluntary ventilation (MVV) were~     assessed at four time points in each of three groups.~   "
148382|NCT01624259|"~     The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide~     compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate~     glycemic control on metformin.~   "
148383|NCT01624246|"~     To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with~     augmented renal clearance (ARC).~   "
148384|NCT01624233|"~     This study will assess the safety and efficacy of ixekizumab in participants with moderate to~     severe psoriasis in Japan.~   "
148385|NCT01624220|"~     The goal of the first part of this clinical research study is to learn how to deliver more~     accurate radiation treatment of tumors in the spine. Researchers also want to learn how~     internal organs might move during radiation treatment.~      The goal of the second part of this study is to learn if it is safe to allow slightly more~     radiation to the normal esophagus when spinal tumors close by are being treated. This may~     result in better tumor control.~   "
148386|NCT01624207|"~     The generic formulation of atorvastatin (Atorva®) 20mg was not inferior to the branded~     formulation of atorvastatin (Lipitor®) 20mg in this 8-week treatment of hyperlipidemic Korean~     patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly higher~     in Atorva group. Both treatments were well tolerated.~   "
148387|NCT01624194|"~     Autism is a pervasive developmental disorder characterized by core deficits in social~     behavior and communication, and the presence of repetitive or stereotyped behaviors. It is~     one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88~     children in the United States. At present, pharmacotherapies target only associated features~     of autism, with no effective drug treatments for the social impairments. Several lines of~     evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for~     the core social deficits in autism. Here we will test the effects of twice daily intranasal~     OT (24 IU) over a 4-week period for enhancing social deficits in male and female children~     aged 6-12 years with autism. This research has high potential to lead to the development of~     more effective treatments and earlier interventions for children with autism.~   "
148388|NCT01624181|"~     With this study the investigators want to determine, if a fast identification of germs,~     causing hospital-acquired infections of the lower respiratory tract, is possible through the~     use of MCC-IMS technology - a method that allows on time detection and identification of very~     small amounts of substances in gas samples. Therefore aspiration samples from the respiratory~     tracts of ventilated patients, which are suspected to develop such an infection, will be~     collected, cultivated and analyzed by MCC-IMS. The investigators want to determine if MCC-IMS~     diagnostic could be a faster alternative to conventional microbiological methods. The results~     of the MCC-IMS analyses therefore will be compared with results of conventional~     microbiological methods.~   "
148389|NCT01624168|"~     The purpose of this study is to determine the feasibility of a 10-week tai chi chuan~     intervention as a treatment for anxiety and sleep quality in young adults.~   "
148390|NCT01624155|"~     Typically, the CTIS Pregnancy Health Information Line in the Department of Pediatrics, School~     of Medicine at the University of California educates pregnant women who call the Information~     Line after an exposure to a medication that might be harmful to the developing baby has~     already taken place, and therefore the opportunity for prevention of that exposure no longer~     exists. Frequently these pregnancies are unintended and occur due to the lack of effective~     contraceptive use. This study facilitates patient access at UCSD to specialized and~     individualized contraceptive counseling for women of reproductive age who are currently~     taking a medication that might be risky in a future pregnancy. This study also measures the~     impact of individualized contraceptive counseling in changing contraceptive behavior.~      Primary Hypothesis: EPIC (EMR)/physician-facilitated referral of female patients of~     reproductive age to an existing specialized counseling service at UCSD will improve the~     utilization of more effective contraception among women of reproductive age who are~     prescribed medications that might be harmful to the developing fetus.~   "
148391|NCT01624142|"~     A study to assess the long term safety and efficacy of Evolocumab (AMG145)on Low Density~     Lipoprotein-Cholesterol (LDL-C) in subjects with severe familial hypercholesterolemia.~   "
148392|NCT01624129|"~     The purpose of the study is to investigate if serological parameters such as extracellular~     Serum-Tryptase (ST) and eosinophilic cationic protein (ECP) are useful for the diagnosis~     and surveillance of the eosinophilic esophagitis (EE).~   "
148393|NCT01624116|"~     Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control~     between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting~     diabetics is to identify which treatment modality leads to the most stable blood glucose~     levels during a fast and how to smooth out these excursions and reduce risks of fast to a~     minimum.~   "
148394|NCT01624103|"~     Results from our preliminary study accepted as e-poster presentation on ESRA (Bordeaux,~     September 2012.) showed significant difference in Comfort Score during Ultrasound Guided~     Supraclavicular Brachial Plexus block (US-SCB) between young and elderly population. However,~     it is unknown whether the difference in Comfort score (1) was associated with reduction of~     local anesthetic (LA) volume in elderly or it is attributed to elderly population by itself.~     The aim of the study is to compare the Comfort score during US-SCB placement in elderly~     patients undergoing upper limb surgery performed with two different volumes of local~     anesthetics (20 ml vs 32 ml).~   "
148395|NCT01624090|"~     Background:~      - Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted~     against some forms of cancer, but was never accepted as a treatment. Research suggests that~     it may be useful against some cancers of the chest, such as lung and esophageal cancer or~     mesothelioma. Researchers want to see if mithramycin can be used to treat these types of~     cancer.~      Objectives:~      - To see if mithramycin is safe and effective against different chest cancers.~      Eligibility:~      - Individuals at least 18 years of age who have lung, esophagus, pleura, or mediastinum~     cancers.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and tumor tissue samples will be used to~          monitor the cancer before treatment.~        -  Participants will receive mithramycin every day for 7 days, followed by 7 days without~          treatment. Each 14-day round of treatment is called a cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the drug for as long as the side effects are not~          severe and the tumor responds to treatment.~   "
148396|NCT01624077|"~     The first trial will involve the generation of donor alloantigen-specific CD4+CD25+ Tregs~     from peripheral blood of pre-transplant patients, the administration of the CD4+CD25+ Tregs~     (1 x 106 cells/kg) at several intervals (for graft specific tolerance induction).~   "
148397|NCT01624064|"~     Enalapril would significantly reduce progression of renal disease in patients with Chronic~     Kidney Disease of Uncertain aetiology.~   "
148398|NCT01624051|"~     Cancer patients are highly variable in their body composition, specifically in the proportion~     of fat and muscle. Some patients tend to gain fat and lose muscle (or lean body mass) at the~     same time. These patients can develop severe muscle wasting, termed sarcopenia. Patients with~     sarcopenia have more severe treatment related toxicity requiring delays, dose reductions and~     stopping of treatment, and have reduced survival. One potential explanation for this is that~     patients with sarcopenia have a reduced volume of lean body mass into which chemotherapy~     drugs are distributed, resulting in a higher concentration and greater toxicity. This study~     will randomize lung cancer patients to either the standard dosing strategy based on body~     surface area or experimental, personalized dosing based on lean body mass. Based on~     retrospective findings in this patient population, the investigators expect to find that~     severe toxicity will be reduced for sarcopenic patients on the personalized dosing arm based~     on lean body mass.~   "
148399|NCT01624038|"~     The study hypothesis that treatment with Erythropoietin (EPO) combined with Human~     Erythropoietin (HUO) therapy will result in hematologic improvement in thalassemia intermedia~     patients.~      Second is to determine whether any of the following correlate with improved hematologic~     response:~      A decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline~     levels,baseline Erythropoietin levels,baseline hemoglobin levels and baseline reticulocyte~     counts (or % circulating nucleated erythroblasts/100 WBCs).~      Goal:~      The aim is to assess the possibility of steady increase of hemoglobin levels in thalassemia~     intermedia patients by at least 1g/dl above baseline levels during therapy using Hydroxyurea~     and Erythropoietin, growth evaluation,quality of life (QoL) and decline transfusion~     requirements during study period. Also to report and compare adverse events with other~     published data regarding.~   "
148400|NCT01624025|"~     A salvage treatment with combination of docetaxel and epirubicin in patients with~     unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based~     study~   "
148401|NCT01624012|"~     The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is~     better in noninvasive ventilation of premature infants than currently used Nasal Continuous~     Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.~      The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more~     synchronous with patient, which will lead to a decrease in need of inspired oxygen.~   "
148402|NCT01623986|"~     The purpose of this clinical study is to investigate if central venous pressure (CVP)~     measurements from the Mespere Venus 1000 System can be used for right atrial pressure (RAP)~     when estimating right ventricular systolic pressure (RVSP) in echocardiography labs.~   "
148403|NCT01623973|"~     To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that could~     interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify the~     impact on daily function, quality of life. In this pilot, randomized, blind and allocation~     concealment clinical trial, nineteen individuals with chronic stroke was randomly assigned,~     after the first evaluation, into two groups: group without restriction (G1), subject only to~     the specific training of paretic UL, and restricted group (G2), which underwent specific~     training of paretic UL and use of the restriction of non paretic UL~   "
148404|NCT01623960|"~     The primary aim of this study is to evaluate the overall quality of life in adult patients~     with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and~     to assess the impact of certain disease and drug related factors (treatment modality,~     presence of viral disease, inhibitor, etc.) on the quality of life.~   "
148405|NCT01623947|"~     Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve~     cycling performance and mental acuity in a dose-dependent response.~   "
148406|NCT01623934|"~     This study includes 2 phases. During phase 1, pregnant women are followed over the course of~     pregnancy. The phase 2 is a follow-up of the mother-child dyad at 3 and 5 year after~     delivery.~      The purpose of this phase 1 is to :~        -  assess the contribution and interactions of adipokines in the development of insulin~          resistance during pregnancy and gestational diabetes;~        -  assess levels of maternal adipokines as determinants of development and fetal growth;~        -  determine the genetic variations that influence levels of adipokines and glucose~          regulation during pregnancy and in newborns.~      The purpose of this phase 2 is to:~        -  identify DNA methylation variations at birth that are predictive of childhood~          overweight/obesity.~        -  identify maternal characteristics associated with DNA methylation variations predictive~          of childhood overweight/obesity.~        -  establish whether the loci predictive of childhood overweight/obesity at birth are still~          differentially methylated at 5 years of age (samples collected at 5 years of age).~        -  identify DNA methylation variations at birth that are predictive of childhood~          neurodevelopment problems at 3 and 5 years of age.~   "
189320|NCT01086436|"~     The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy~     children aged 2 to 6 years in China.~   "
148407|NCT01623921|"~     Background: Lung contusion affects 17%-25% of adult blunt trauma patients, and is the leading~     cause of death from blunt thoracic injury. Statins are lipid-lowering drugs with recently~     suggested anti-inflammatory and antioxidant properties. Cyclo-oxygenase-2 (COX-2) is a key~     enzyme in the production of prostaglandins (PG), and evidence suggests that COX-2 plays an~     important role in the pathogenesis of acute lung injury (ALI).~      Aims: The current study aims at evaluating the beneficial effects of statins and COX-2~     receptor inhibitors on ALI elicited by blunt trauma to the chest.~      Methods: After approval by the institutional ethics and a scientific committee, and obtaining~     informed consent , patients admitted to the emergency department (ED) due to blunt trauma~     with a diagnosis of lung contusion will be enrolled in the study.The effects of statins and~     COX 2 inhibitors on ALI will be assessed by recording clinical parameters and measuring~     inflammatory mediators levels in the serum and in the bronchoalveolar space.~      Expected results: The investigators expect to find that the proposed treatment will be~     effective in reducing ALI burden. The investigators also suppose that using a combination of~     those drugs will synergistically potentiate their effect on ALI.~   "
148408|NCT01623908|"~     The main purpose of this study is to observe and assess the impact of adjuvant zoledronate on~     bone density in breast cancer patients.~      The second purposes:~        -  The efficacy of adjuvant zoledronate~        -  The safety of adjuvant zoledronate~        -  The bone loss of breast cancer patients in Guangdong~        -  The correlation between bone loss of breast cancer patients and treatment of disease in~          Guangdong~   "
148409|NCT01623895|"~     To investigate effect of genetic variations on the toxicities and find optimal target~     population, the investigators planned to analyze the genetic polymorphisms of~     UDP-glucuronosyltransferase.~   "
148410|NCT01623882|"~     The primary purpose of this study is to evaluate the safety and efficacy of the concurrent~     use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous~     stasis lower extremity ulcers.~   "
148411|NCT01623869|"~     This phase II trial studies how well trebananib works in treating patients with advanced~     angiosarcoma that cannot be removed by surgery. Trebananib may stop the growth of tumor cells~     by blocking blood flow to the tumor.~   "
148412|NCT01623856|"~     This research studies genes associated with non-Hodgkin lymphoma in young patients. Studying~     samples of blood and tissue from patients with cancer in the laboratory may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to cancer~   "
148413|NCT01623843|"~     The purpose of this study is to determine whether surgical correction of hip impingement~     morphology via arthroscopic osteochondroplasty (shaving of bone) will provide improved~     clinical results (decreased pain and improved function) in adult patients with~     femoroacetabular impingement (FAI) compared to arthroscopic lavage (washing out of painful~     inflammation debris) and treating obvious damage of the hip joint.~   "
148414|NCT01623830|"~     The overall aim of this project is to determine if using a cue to trigger (and reactivate)~     the fear memory 10 minutes prior to exposure treatment sessions leads to less anxiety in~     patients with a fear of flying. The long term goals are to establish if targeting the~     reconsolidation of fear with a reminder of the fear is effective for human clinical~     populations in reducing relapse (return of fear). In this investigation, the investigators~     propose to treat 64 patients diagnosed with a fear of flying (FOF) using virtual reality~     exposure therapy (VRE). All patients in the study will receive exactly the same exposure~     treatment using a virtual airplane.~   "
148415|NCT01623817|"~     The goal of tish clinical research study is to identify that loading of vancomycin can~     faciliate rapid attainment of target trough serum vancomycin concentration.~   "
148416|NCT01623804|"~     The purpose of this pilot study is to determine the feasibility of conducting a high quality~     clinical trial to investigate the effects of low intensity, pulsed ultrasound on knee~     osteoarthritis pain and physical function.~   "
148417|NCT01623791|"~     The aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria,~     random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300~     mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe~     preeclampsia. The cross-sectional longitudinal study design used, 209 patients with~     pre-diagnosed preeclampsia in which in our inpatients clinic included this study. Random~     urine samples were taken before the 24 hour urine collection for spot urine analysis for~     evaluated proteinuria and protein/creatinin ratio. 24 hour urine analysis was performed in~     all patients as the gold standard of the urine total proteinuria.~   "
148418|NCT01623778|"~     Along with the improvement of the accuracy of detection of HBV serological markers, the~     optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection~     becomes feasible. Currently, the recommendation of optimized treatment especially interferon~     therapy are mainly based on retrospective studies, it still lacks prospective evidence. This~     study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks~     optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg~     positive CHB with inadequate response to 24 weeks interferon treatment.~   "
148419|NCT01623765|"~     To collect data of all patients who have undergone Endobronchial ultrasound for diagnosis or~     staging of suspected lung cancer~   "
148420|NCT01623752|"~     It is known from the COMET-trial that patients who start Enbrel treatment early have a great~     chance of reaching clinical remission and radiographic nonprogression. It is still unclear,~     however, how many patients with early arthritis achieve remission and radiographic~     nonprogression under the conditions of routine rheumatologic care and the local~     recommendations of Enbrel treatment (pre-treatment of at least 2 DMARDs, one of them MTX).~      Therefore, no robust x-ray data are available to show/demonstrate~        -  the average extent of x-ray damage in routine patients on Enbrel outside clinical~          studies.~        -  if the outstanding effect on structural damage of Enbrel can be reproduced in routine~          practice.~        -  that the 'Silent Progressor' is an issue relevant not only in clinical trials, but also~          for day-to-day decision making.~        -  the optimal onset of Enbrel treatment in the course of the disease to prevent~          radiographic damage~   "
148831|NCT01618370|"~     This study is a prospective, interventional, open-label, multi-center early access program~     for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate~     resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional~     short and long term safety data on the product.~   "
148429|NCT01623635|"~     Pain following laparoscopic surgery continues to be a clinically important problem with 80%~     or more patients requiring opioid analgesia post-operatively to control their pain. By~     reducing this surgical complication patients can experience less discomfort and be discharged~     from the recovery room more rapidly leading to reduced resource utilization and expense.~      HYPOTHESIS: Post-operative pain after laparoscopic procedures could be treated by topical~     anesthetics sprayed directly into the abdomen (inside the abdominal cavity, on the nerve~     endings of the visceral peritoneal lining and diaphragm surface) via the surgical incision~     METHODS: Randomized controlled trial on use of topical anesthetic (namely 0.25% ropivacaine)~     delivered directly onto the target sites both at the beginning and the end of surgery in~     patients undergoing laparoscopic gynecologic procedure for uterine or adnexal benign~     pathology. The drug will be delivered using a CE approved delivery system that will direct a~     fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the~     cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).~      GOAL: to assess the efficacy of intraperitoneal topical anesthesia in reducing postoperative~     pain, opioid requirements in patients undergoing laparoscopic gynecologic procedure for~     uterine or adnexal benign pathology~   "
148430|NCT01623622|"~     The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with~     severe upper limb hemiplegia following stroke.~   "
148431|NCT01623609|"~     The purpose of this study is to demonstrate the Bioequivalence, assess food administration on~     the Pharmacokinetics with naloxegol.~   "
148432|NCT01623596|"~     A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to~     fingolimod or approved disease modifying therapy. Patients will be be treatment naive or have~     only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) .~     Patients will be able to switch to different treatment for safety, efficacy, tolerability or~     convenience during the study.~      Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on~     treatment. Secondary objectives are to compare reasons for discontinuation, adverse events,~     cognitive impairment, medication satisfaction and change in brain volume measured by MRI.~   "
148433|NCT01623583|"~     An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a~     superior option for delivery of dialysis, but requires needles to be inserted. Patients on~     dialysis who indicate fear of needles as the reason for not switching from a long-term~     central venous catheter (CVC) access to a fistula or graft access and who otherwise meet the~     eligibility criterial will be asked to participate. Patients will receive either a standard~     or an enhanced intervention to address their fear of needles. The enhanced intervention~     includes the standard intervention plus video training about Synera and trying out an actual~     patch. Over the 4 months following the intervention, how many patients sign up to switch~     access will be tracked.~   "
148434|NCT01623570|"~     The aim of the study is to compare the efficacy and safety of r-hFSH+r-hLH in a 2:1 ratio~     with human Menopausal Gonadotropin Highly Purified (hMG-HP), in WHO type I anovulation, HH~     women.~      This open-label monocentric, randomized comparative trial, to receive the two different~     standard clinical practice treatments:~        -  1 vial of Pergoveris: (vial/powder 150 International unit (IU) r-hFSH+ 75IU r-hLH)~        -  2 vials of Menopur: (vials/powder hMG 75IU).~      Follicular development were monitored until the protocol hCG requirement is met and a single~     injection of hCG was administered.~      Main Outcome Measures were follicular development i.e. follicle ≥ 17 millimeters (mm),~     pre-ovulatory E2 ≥ 400 picomole/Liter (pmol/L) and mid-luteal phase Progesterone (P4) ≥ 25~     nanomole/Liter (nmol/L).~   "
148435|NCT01623557|"~     This study aims to assess the safety and effectiveness of four new candidate malaria~     vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS & MVA ME-TRAP. These vaccines consist of viruses~     (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans~     and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP).~     The hope is that these vaccines will induce immune responses in vaccinees that are able to~     prevent malaria.~      This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria~     infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP.~      The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and~     Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in~     Southampton, UK. The malaria challenge will take place at the insectary at Imperial College~     (Infection and Immunity Section) in London, UK.~   "
148436|NCT01623544|"~     The objective of this study is to compare the real-world effectiveness of BFC and FSC in~     asthma patients new to ICS/LABA combination therapy in a population of U.S. health plan~     enrollees.~   "
148437|NCT01623531|"~     The aim of the study is to show that first line treatment with concentrated fibrinogen has~     superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and~     cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.~   "
148438|NCT01623518|"~     This is a first in man dose escalation study, to assess the safety and immunogenicity of the~     candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults~     aged 18-50. Volunteers will be enrolled and doses will be escalated according to a 3+3~     study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine,~     volunteers will be followed up to assess the side effect profile of the vaccine and to take~     blood tests. A series of immunology assays will be performed to determine how potent the~     vaccine is at inducing an immune response.~   "
148453|NCT01623323|"~     This is an open-label, multicenter study designed to assess the safety of intranasal~     administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose~     device in subjects with chronic sinusitis with or without nasal polyps. The study consists of~     an up-to-7-day pretreatment phase followed a 3-month open-label treatment phase. The duration~     of each subject's participation is approximately 13 weeks.~   "
148454|NCT01623310|"~     This is an open-label, multicenter study designed to assess the safety of intranasal~     administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose~     device in subjects with chronic sinusitis with or without nasal polyps. The study consists of~     an up-to-7-day pretreatment phase followed a 12-month open-label treatment phase. The~     duration of each subject's participation is approximately 53 weeks.~   "
148455|NCT01623297|"~     A study will be conducted to determine if there is any cognitive benefit in elderly patients~     having open versus minimally invasive colon cancer surgery.~   "
148439|NCT01623505|"~     Research Aims~      The aims of this research study are:~        1. To determine which of the following three smoking cessation medications is most~          effective in achieving cessation:~             -  Nicotine Patch~             -  Nicotine Patch + gum or inhaler~             -  Varenicline (Champix;~        2. To investigate how often participants experience neuropsychiatric symptoms over the~          course of their cessation attempt and to assess whether:~             -  They occur more often when taking one medication versus another~             -  They occur more often in those with or without psychiatric illnesses.~      Hypotheses to be Tested~      The hypotheses to be tested include the following:~        1. The CO-confirmed continuous abstinence rate from 5 weeks to 52 weeks following a target~          quit date will be significantly higher in smokers receiving long-term transdermal NRT in~          combination with other NRT products or those receiving varenicline compared to those~          receiving transdermal NRT alone.~        2. Some participants will experience neuropsychiatric symptoms during their cessation~          attempt, and those in the varenicline group will experience a greater incidence of~          neuropsychiatric symptoms than those in the groups receiving transdermal NRT alone or in~          combination with other NRT products. Patients with psychiatric illnesses will report~          higher levels of withdrawal symptoms than those without psychiatric illnesses.~   "
148440|NCT01623492|"~     Eisenmenger Quality Enhancement Research Initiative (QuERI) is a multi-center, observational,~     US-based longitudinal program, with enrollment of consecutive Eisenmenger patients who meet~     enrollment. Patient data will be collected prospectively for three years. Individual~     physician feedback will be provided on data collected with the purpose of improving the~     management of patients - quality enhancement research initiative (QuERI) process.~   "
148441|NCT01623479|"~     This is an observational study of patients treated with bimatoprost 0.03% (Latisse®) for at~     least 12 months for hypotrichosis of the eyelashes.~   "
148442|NCT01623466|"~     Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will~     be evaluated.~   "
148443|NCT01623453|"~     This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of~     ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical~     trial.~   "
148444|NCT01623440|"~     This study aims to characterize the neurobiology of obesity in American Indians (AI) using~     functional MRIs to examine the correlation between brain response to food stimuli in AI~     women. A functional MRI (fMRI) is used to visualize brain activity when obese and lean AI~     women look at images of fattening food, non-fattening food and non-food objects. Additionally~     examined is the effect of the drug naltrexone to suppress brain response to visual food cues~     and calorie intake in the women.~   "
148445|NCT01623427|"~     Postoperative pain and time taken to return to normal activities after laparoscopic surgery~     are significantly shorter. Wound infections still occur and contribute to prolonged hospital~     stays and morbidity. Typically, port incision sites are covered with a standard dressing~     (approximating strips and a gauze). Although the umbilical wound infection rate in~     laparoscopic surgery is considered to be low, a recent study by Muensterer and Keijzer showed~     that the umbilical wound infection rate after single incision laparoscopic appendectomy in~     children is approximately 7%. In the same retrospective study, the investigators demonstrated~     that a simple low cost vacuum dressing can significantly reduce the infection rate. The aim~     of this prospective randomized controlled trial is to determine if the simple vacuum dressing~     is superior to a standard dressing in reducing laparoscopic postoperative umbilical wound~     infections. All patients under 17 years of age undergoing a laparoscopic operation in the~     Children's Hospital will be randomized to a standard postoperative dressing or a standard~     postoperative dressing with vacuum applied to it. The vacuum will be applied with a 22g~     needle on a 10ml syringe passed percutaneously from outside the dressing into the gauze and~     the air around the gauze is evacuated. The umbilical wounds will be evaluated 8-10 days~     postoperatively in the clinical research unit of the Manitoba Institute of Child Heath~     according to a standardized and validated wound evaluation tool from the Canadian Center for~     Disease Control. Primary outcome measure in this study is postoperative wound infection. A~     sample size calculation using the retrospective data demonstrated that the investigators need~     275 patients in each group for the Chi-squared test to have an 80% chance of detecting a~     difference in wound infection rate of 6% at the 5% level of significance. Based on the annual~     number of laparoscopic operations in the Children's Hospital (around 400) the investigators~     anticipate completing the inclusion of patients within a two-year period.~   "
148446|NCT01623414|"~     The purpose of this study is to examine the amount of sunlight exposure and vitamin D status~     of adolescent schoolchildren of South Asian ethnicity in each season throughout the year.~   "
148447|NCT01623401|"~     This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701~     FA once daily for 10 days and will include ophthalmologic and neurologic assessments.~   "
148448|NCT01623388|"~     This research is being done to find out if significant changes in blood glucose cause bad~     outcomes in patients with diabetes.~   "
148449|NCT01623375|"~     This trial is conducted in Europe. The aim of the trial is to investigate the absolute~     bioavailability of insulin degludec (IDeg) in healthy subjects.~   "
148450|NCT01623362|"~     The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride~     concentration in liquid dentifrices in the control of dental caries in early childhood, in~     non-fluoridated area. This study also aims to assess the effect of the consistency of liquid~     dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the~     toenails, to estimate the fluoride intake from these formulations.~   "
148451|NCT01623349|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational combination of drugs. Phase I studies also try to define the appropriate~     dose of the investigational combination to use for further studies. Investigational means~     that the combination of these drugs is still being studied and that research doctors are~     trying to find out more about it. It also means that the FDA has not approved either of these~     drugs nor the combination of being tested for use in patients, including people with your~     type of cancer.~      BKM120, BYL719 and olaparib are drugs that may stop cancer cells from growing abnormally.~     These drugs when combined in laboratory experiments with animals, have demonstrated~     anti-cancer activity. Information from these other research studies suggests that the~     following agents BKM120, BYL719 and olaparib, may help to shrink tumor cells in the types of~     cancers being studied in this research study.~      In this research study, the investigators are looking for the highest dose that can be given~     safely and also to see if the combination of BKM120 or BYL719 and olaparib is effective in~     treating your type of cancer.~   "
148452|NCT01623336|"~     The purpose of the study is to demonstrate the noninferiority of BIP48 (48 kDa peginterferon~     alfa-2b) compared to Pegasys ® (40 kDa peginterferon alfa-2a) associated with ribavirin, in~     naive patients with chronic hepatitis C.~   "
149097|NCT01614873|"~     Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical~     ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory~     Assist)~   "
148459|NCT01623245|"~     Cardiac amyloidosis are related to the accumulation of fibrillar proteins in the~     extracellular leading to disruption of the cardiac tissue architecture. Amyloidosis in~     transthyretin (TTR) are the most common hereditary amyloidosis but remain poorly studied at~     heart. This is serious and deadly. The prevalence of TTR amyloidosis is probably~     underestimated in hypertrophic cardiomyopathy (HCM) often of unknown etiology because of the~     lack of systematic implementation of myocardial biopsy because of their side effects.~   "
148460|NCT01623232|"~     This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants~     aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion~     adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three~     reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed,~     unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three viral~     strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine will be~     assessed.~   "
148461|NCT01623219|"~     The investigator proposes to examine treatment for Posttraumatic Stress Disorder for Veterans~     who served in Iraq and Afghanistan provided through telemedicine which connects patients to~     doctors in different locations using the internet. In this study, Veterans will receive~     prolonged exposure therapy (PE). This treatment has been shown to be effective in reducing~     PTSD symptoms. For this study 9 weekly 90 minute sessions will be given over a period of up~     to 3 months. The first 2 sessions of each treatment will involve education, rational and~     treatment preparation. Sessions 3-9 will consist of recounting the traumatic event out loud~     and repeatedly. The purpose of this study is to determine if this treatment is effective when~     given through telehealth. To this end, the investigators propose to enroll up to 20~     individuals who will access the investigators services through the GA telehealth network who~     has hundreds of telehealth sites across the state of Georgia. Patients will go to these sites~     to access the investigators therapists using GA telehealth equipment. The investigators~     hypothesize that PE delivered remotely through telemedicine will work to reduce the symptoms~     of PTSD.~   "
148462|NCT01623206|"~     The objective of this study is to find the maximum tolerated dose and preliminary efficacy of~     desmopressin as an haemostatic agent, when is administered to patients with colorectal cancer~     and rectal bleeding, before specific oncologic treatment with surgery and/or chemotherapy~     and/or radiotherapy.~   "
148463|NCT01623193|"~     This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia~     to more dilute 4:1 blood cardioplegia during cardiac surgery. The hypothesis is that~     all-blood cardioplegia will be associated with less blood transfusion and better cardiac~     function.~   "
148464|NCT01623180|"~     The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is~     non-inferior to a bare metal stent at one year as measured by the composite safety endpoint~     of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and~     that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at~     one year.~   "
148465|NCT01623167|"~     Background:~        -  Severe aplastic anemia is a rare and serious blood disorder. It happens when the immune~          system starts to attack the bone marrow cells. This causes the bone marrow to stop~          making red blood cells, platelets, and white blood cells. Standard treatment for this~          disease is horse-ATG and cyclosporine, which suppress the immune system and stop it from~          attacking the bone marrow. However, this treatment does not work in all people. Some~          people still have poor blood cell counts even after treatment.~        -  Eltrombopag is a drug designed to mimic a protein in the body called thrombopoietin. It~          helps the body to make more platelets. It may also cause the body to make more red and~          white blood cells. Studies have shown that eltrombopag may be useful when added to~          standard treatment for severe aplastic anemia. It may help improve poor blood cell~          counts.~      Objectives:~      - To test the safety and effectiveness of adding eltrombopag to standard immunosuppressive~     therapy for severe aplastic anemia.~      Eligibility:~      - Individuals at least 2 years of age who have severe aplastic anemia that has not yet been~     treated.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~          Blood and urine samples will be collected.~        -  Participants will start treatment with horse-ATG and cyclosporine. Treatment will be~          given according to the standard of care for the disease.~        -  Cohort 1: After 14 days, participants will start taking eltrombopag. They will take~          eltrombopag for up to 6 months.~        -  Cohort 2: After 14 days, participants will start taking eltrombopag. They will take~          eltrombopag for up to 3 months.~        -  Cohort 3 and Extension Cohort: Participants will start taking eltrombopag on Day 1. They~          will take eltrombopag for up to 6 months.~        -  Participants may receive other medications to prevent infections during treatment.~        -  Treatment will be monitored with frequent blood tests. Participants will also fill out~          questionnaires about their symptoms and their quality of life.~   "
148466|NCT01623154|"~     The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring~     13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath~     test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in~     pediatric subjects.~   "
148467|NCT01623141|"~     The aim of the study is to investigate the correlation between increased bone metabolism in~     the 3 phase bone scintigraphy (TPBS) and decreased pressure pain thresholds in patients with~     complex regional pain syndrome (CRPS) of the upper limb and a non-CRPS-group. The~     investigators assume that there will be a significant correlation between the investigated~     values in the CRPS-group whereas the non-CRPS-group shows no significant correlation.~   "
148468|NCT01623128|"~     A randomized, controlled trial will be conducted during which pregnant women will be~     randomized to receive the intervention - viewing a prenatal education video about how to~     breastfeed an infant - or the sham intervention - viewing a prenatal education video about~     maternal nutrition and physical activity during pregnancy. Participants will be interviewed~     via telephone at one, three, and six months post-partum to determine how they feed their~     infants at each of these time frames.~   "
148469|NCT01623115|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels~     after 24 weeks of treatment in comparison with placebo.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time~          points~        -  To evaluate the effects of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
148500|NCT01622686|"~     This randomized controlled trial seeks to test the effect of reformatted prescription drug~     container labels, compared to usual labels, on participants' understanding of their~     medications. The study will also assess the effect on self-efficacy and self-reported~     medication adherence. English and Spanish speaking patients are eligible, with a planned~     sample size of up to 500 adults.~   "
149131|NCT01614431|"~     This study intends to verify the interference of N acetyl cysteine in the progression of~     chronic kidney disease in patients with Nephropathic Cystinosis.~   "
195471|NCT01004809|"~     Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in~     Korean androgenetic alopecia patients~   "
148470|NCT01623102|"~     Advanced non-small-cell lung cancer (NSCLC) patients without epidermal growth factor receptor~     (EGFR) mutations show a poor prognosis. Gemcitabine combined with cisplatin chemotherapy is~     an effective treatment measures for EGFR mutation-negative NSCLC patients, but the prognosis~     remains poor. Chemotherapy combined with targeted monoclonal antibody treatment may be better~     treatment options in these patients. Monoclonal antibodies, such as bevacizumab, can block~     tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood~     vessels and spread. It is not yet known whether cisplatin and gemcitabine is more effective~     when given alone or with bevacizumab. This randomized trial studies how well giving cisplatin~     and gemcitabine alone or in combination with Bevacizumab (Avastin) works in treating patients~     with stage IIIB/IV non-squamous NSCLC without EGFR mutations.~   "
148471|NCT01623089|"~     Asthma is a heterogenous disease. Different patients have different presentations, course of~     disease and response to treatment.~      The investigators would like to study our population of more severe asthma and find out about~     their profile - demographic, clinical and inflammatory.~   "
148472|NCT01623076|"~     This study seeks to determine the biologic causes of inflammation in patients with Transverse~     Myelitis (TM) Neuromyelitis Optica Spectrum Disorder (NMOSD) and related conditions. While~     patients will be treated according to decisions with their treating physician, this study~     will collect data and samples from patients prospectively to gain a better understanding of~     the disease. We are seeking to understand why some patients respond to medications, while~     others do not. We also seek to understand what happens biologically, preceding relapses.~     Gathering these data and samples will allow researchers to identify new ways of diagnosing~     and treating these diseases. Data and samples will be shared with researchers around the~     world to support collaborative efforts to treat these conditions.~   "
148473|NCT01623063|"~     To detect similarities and differences in the endometrium of fertile and infertile patients~   "
148474|NCT01623050|"~     The purpose of this study is to assess safety and performance of the SinuSys Dilation System~     for dilation of the maxillary sinus ostium.~   "
148475|NCT01623037|"~     The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for~     non-invasive fat layer reduction in flanks for Asian patient population.~   "
148476|NCT01623024|"~     Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of disorders characterized by~     predominantly macrovesicular hepatic steatosis occurring in individuals in the absence of~     significant alcohol consumption. In this context it is possible to distinguish a condition of~     simple fatty liver, where the only histologic finding is the presence of steatosis, from a~     state of non-alcoholic steatohepatitis (NASH), characterized by hepatocellular~     injury/inflammation with or without fibrosis. The prevalence of NAFLD is around 20-30% in the~     general population. With a rapid increase in the risk factors for metabolic syndrome, NAFLD~     has become the most common cause of liver disease in Western countries. The clinical~     relevance of NAFLD arises from the fact that a considerable proportion of subjects (20-30%)~     develop NASH, and this condition can progress to cirrhosis in up to 15% of patients. In~     addition NAFLD, and particularly NASH, represents a cardiovascular risk factor, independent~     of other well-known conditions contributing to heart and vascular diseases.~      Lifestyle modification is the effective medical treatment recommended for NASH, while there~     is currently no pharmacologic therapy of proven benefit in these patients. Several pilot~     studies, using insulin sensitizers (thiazolidinediones or metformin), and antioxidants, like~     vitamin E, have provided inconclusive evidence that these drugs may improve clinical and~     histological features of NASH.~      In the complex and not completely understood pathogenic puzzle of NAFLD and NASH, also~     vitamin D might have an important role. Vitamin D deficiency is associated with many common~     pathological conditions frequently observed in NAFLD, like cardiovascular disease, and~     insulin resistance. A recent paper by Targher and colleagues showed low vitamin D serum~     levels in NAFLD patients, identifying an inverse relation between vitamin D levels and the~     severity of liver disease. In keeping with the above data, recent experimental evidence also~     suggested the potential ability of vitamin D, through interaction with its nuclear receptor~     (vitamin D receptor - VDR), to interfere with inflammatory response, T cell function and~     fibrogenesis. Therefore considering the link between vitamin D serum levels, severity of~     NAFLD, and risk factors for NAFLD, we speculate that vitamin D might represent a new~     therapeutic target in the management of NASH patients.~   "
148477|NCT01623011|"~     Shoulder problems causing pain and decreased function are very common. Many of these problems~     are related to the rotator cuff tendons. Shoulder arthroscopy surgery (keyhole surgery) is a~     common treatment for this pain. This can involve an Arthroscopic Subacromial Decompression~     (ASAD) an operation used to remove bony spurs which may be the cause of the pain. This~     procedure is widely used despite limited evidence of any effectiveness. This is a randomised~     controlled trial that will compare ASAD against an investigational shoulder arthroscopy~     (without spur removal/decompression) to indicate whether spur removal is really necessary and~     in turn, assessing the effectiveness of the ASAD procedure. Both surgical interventions are~     routine and will mirror each other except for the spur removal element. Both treatments will~     be compared against a control (non operative management with specialist reassessment) group~     to indicate whether surgery in general is effective for patients with subacromial pain.~     Patients randomised to either of the surgical options will be blinded to the type of surgery~     they have. This is a multicentre trial taking place in 10 centres in England and Wales. Two~     satellite studies will also take place. One will involve a subset of patients undergoing MRI~     scans to examine the effects of their shoulder pain on their brain transmissions. The other~     will involve collecting tissue samples from patients undergoing surgery.~   "
148478|NCT01622998|"~     The primary aim of this research study is to determine whether titrated, patient-directed~     transdermal patch NRT, based on smoking history and symptoms of nicotine withdrawal, improves~     long-term rates of smoking cessation in patients motivated to quit smoking when compared to~     patients using the standard transdermal NRT patch protocol. The following hypothesis will be~     tested: CO-validated continuous abstinence rate at 52 weeks post target quit date will be~     higher for the titrated, self-directed NRT group compared to the standard NRT treatment~     group.~   "
148479|NCT01622972|"~     The University of Nottingham have been developing new, non-invasive magnetic resonance~     imaging (MRI) techniques to image the bowel. Building on those studies the investigators want~     to study, in healthy volunteers, the effects of purging on the colon. The investigators plan~     two studies using their novel MRI techniques in healthy volunteers to demonstrate how doses~     of a preparation designed to clean the bowel alters small and large bowel water content and~     transit. The investigators will also define the changes induced in colonic microbiota and how~     these are linked to changes in transit and the structure of colonic contents. This~     experimental model is comparable to an episode of acute diarrhea, therefore this study will~     also improve their understanding of the effects of diarrhea on bowel physiology.~      Following from the above study, the investigators would like to extend this study on patients~     who have functional constipation and previously have not responded to conventional laxatives.~   "
195802|NCT01000467|"~     To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in~     healthy male subjects.~   "
148480|NCT01622959|"~     Pain is the most common reason that patients present to an emergency department (ED) and is~     often inadequately managed. Evidence suggests that acupuncture is effective for pain relief,~     yet it is rarely practiced in the ED.~      In 1998, a United States National Institute of Health Consensus Conference Panel reviewed the~     status of acupuncture and concluded that: There is sufficient evidence of acupuncture's~     value to expand its use into conventional medicine and to encourage further studies of its~     physiology and clinical value. Similarly, in 2002, the World Health Organisation (WHO)~     stated that acupuncture is a safe, simple and convenient therapy and that its effectiveness~     as analgesia has been established in controlled clinical studies.~      Notwithstanding these difficulties, it has been shown that acupuncture analgesia in the~     treatment of chronic pain is comparable to morphine and that its better safety profile and~     lack of dependence makes it the preferred method of choice for these conditions.~      There are very few clinical trials of acupuncture for acute pain to inform clinical practice;~     that's why we have the idea to do this study in our emergency department.~   "
148481|NCT01622946|"~     The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the~     suction drain following a total hip replacement~   "
148482|NCT01622933|"~     This clinical trial is to determine if the addition of a standard of care drug,~     interferon-alfa 2b (IFN), with an investigation vaccine will have any affect on the immune~     system and/or your cancer. The investigational vaccine will be made with genes that are~     specific to melanoma and will be given intradermally (i.d.) every two weeks for a total of 3~     vaccines.~      After the vaccines, subjects will be randomized to either receive a boost of high dose IFN or~     no boost. IFN will be administered intravenously (into a vein) for 5 consecutive days (Monday~     through Friday) every week for 4 weeks. Administration will begin approximately 30 days (± 7~     days) after the 3rd vaccine. The first dose of IFNα2b may begin within 10 business days of~     randomization. All subsequent procedure dates for Group A will be based on the date of the~     first dose of IFNα2b.~   "
148483|NCT01622920|"~     The investigators have now established a technique to measure enamel thickness which has been~     shown to work well in-vitro. The teeth tested so far, obtained from the Dental School Tissue~     Bank, have been molars or pre-molars. In these cases, the measurement is made more difficult~     by the curvature of the tooth surface and it seems likely that flatter larger, incisors would~     give more satisfactory results. The investigators therefore wish to establish in-vivo whether~     this hypothesis is correct.~   "
148484|NCT01622907|"~     Prospective, multi-center, investigator-driven trial. This study hypothesizes that combining~     surgical endoscopic and transcatheter techniques in a staged fashion provides superior~     clinical outcomes than isolated surgical/EP approaches in patients with persistent AF lasting~     > 1 year but > 5 years.~      The proposed procedure involves the creation of cardiac lesions with epicardially applied~     radiofrequency (RF) ablation through a minimally invasive surgical (MIS) approach followed by~     a delayed EP ablation procedure performed at 1-2 months from the surgical operation.~   "
148485|NCT01622894|"~     Genetics of mendelian forms of young onset Alzheimer Disease (GMAJ project)~      Introduction : Autosomal dominant forms of Alzheimer disease (AD) are characterized by young~     age of onset. In France the prevalence was estimated at around 1000 cases. The Phenotypical~     Expression: There is diversity in phenotypical expression, associating dementia, spastic~     paraplegia, early extrapyramidal syndrome, ataxia or stroke caused by severe cerebral amyloid~     angiopathy. Diversity in neuropathological expression is demonstrated by the presence of~     cotton wool plaques, Lewy bodies with Lewy neurites and severe cerebral amyloid angiopathy.~      The study of mendelian forms is decisive in the physiopathological comprehension of AD and~     related diseases, since the alteration of those genes involved is sufficient to cause the~     disease. In AD, identification of these genetic causes allows the formulation of the amyloid~     hypothesis, which is the basis of current therapeutic developments concerning the Ab peptide.~     Currently three genes (APP, PSEN1, PSEN2) are identified in early onset mendelian forms and~     their mutations are involved in 80% of the 139 French families, studied since 1993 within the~     framework of U614 and the National Reference Centre for Alzheimer Disease in young subjects~     (CNR-MAJ).These results are arguments in favor of the GMAJ project and have two main~     objectives:~      (i) to identify new genes in mendelian AD forms without detectable alteration on known genes.~      (ii) to correlate phenotypes and genotypes within families associated with known mutations~     and extend the description of the phenotypical spectrum.~      Population: Families eligible for this study are those with at least 2 individuals with AD~     criteria (clinical or neuropathological) with onset before 65 years of age. Duration of~     inclusion is 3 years. This multicentre study groups 23 clinical centres. The inclusion number~     is 50 new families per year.~      Method: Extension and description of families with unknown genetic causes, inclusion of novel~     families with autosomal dominant AD. The successive steps of the project are the following:~      (i) Thorough phenotypical characterization in order to document family history and~     characterize the probands and affected related subjects according to standardized protocol~     for clinical, neuropsychological, biological (biomarker determination in plasma and~     cerebrospinal fluid) and imaging data (MRI, TEMP).~      (ii) Identify known genetic causes (PSEN1/2, APP) with novel autosomal dominant families.~      (iii) Extend analysis of the pedigrees of families with unknown genetic causes.~      (iv) Identify novel genetic causes within these families which are negative for known~     mutations.~      This study uses 3 methods:~        -  pangenomic search is performed for microalterations (Copy Number Variants or CNV) by~          Comparative Genomic Hybridization (CGH) with high resolution (10 kb on average).~        -  potential targets are then validated by the study of large control populations,~          intrafamilial cosegregation and functional validation.~        -  the remaining families at the end of this stage will be characterized by means of high~          throughput sequencing of all exonic areas.~           (v) Follow up study of patients and siblings with 2 goals:~        -  evaluation of the disease course and consequences (individual, familial and social);~        -  occurrence of novel AD cases within the family.~      (vi) Neuropathological description with potential novel description of atypical AD cases.~      Results and consequences: Identification of novel genetic causes of AD are of importance in~     completing the mechanisms of the amyloidergic hypothesis. This project is useful to promote~     the guidelines on the genetic diagnosis of AD in France.~   "
148486|NCT01622881|"~     The investigators examined the efficacy of nefopam in patients undergoing kidney~     transplantation.~   "
148487|NCT01622868|"~     This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic~     radiosurgery with or without lapatinib ditosylate works in treating patients with breast~     cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2)~     on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill~     tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy~     that delivers a single, high dose of radiation directly to the tumor and may kill more tumor~     cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib~     ditosylate is an effective treatment for brain metastasis from breast cancer.~   "
148488|NCT01622855|"~     The purpose of this study was to evaluate whether a brief intervention in video format~     delivered in the post assault medical exam setting and including education about assault~     reactions and instruction in and modeling of successful coping strategies would reduce post~     assault drug use or abuse and PTSD symptoms as compared to standard care.~   "
148489|NCT01622842|"~     The overall objectives were to investigate if characteristic dimensions for tissue and~     vessels determined from measured bioimpedance spectra would provide the same values as~     dimensions determined from MR images of the upper arm and verify that temporal variations of~     impedances could be converted to blood pressure.~   "
148490|NCT01622829|"~     This study tries to improve patient's activity by a Prescription for Activity led by~     physiotherapists in secondary health care setting.~      Three groups are compared in regard to their increase of physical activity.~   "
148491|NCT01622816|"~     Comparing visual acuity measurements (measurements of how well you can see) using a standard~     ETDRS (Early Treatment Diabetic Retinopathy Study) chart and a handheld ETDRS chart~   "
148492|NCT01622803|"~     Internal biliary drainage using stent is used for malignant hilar obstruction such as~     cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.~      Bilateral drainage is more physiologic and have more long patency than unilateral drainage.~      There are two methods of bilateral drainage: Y-stent and side by side.~      However there are no clinical data about comparing the effectiveness of these two methods.~      Therefore the investigators want to compare the clinical outcomes of two methods:~      Y-stent and side by side.~   "
148526|NCT01622348|"~     The purpose of this study is to evaluate different dose levels of IMO-3100 compared to~     placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.~   "
148527|NCT01622335|"~     The study is prospective and double blind. In the clinic, patients undergoing hysterectomy~     that meet the criteria for inclusion into the study and agreed to participate in the study~     will be randomized into two groups.~   "
148528|NCT01622322|"~     The study is prospective and double blind. In the clinic, patients undergoing inguinal hernia~     surgery that meet the criteria for inclusion into the study and agreed to participate in the~     study will be randomized into two groups. In the first group of patients will receive Nitrous~     Oxide and In the second group of patients will receive oxygen during the general anesthesia.~   "
148493|NCT01622790|"~     Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in~     phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations~     (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of~     tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first line~     regimen due in large part to its convenient presentation as a full treatment regimen in a~     single product, other options are needed. A fixed-dose combination of DTG/abacavir~     (ABC)/lamivudine (3TC) is one such opportunity. Part A of this study will be a single-dose,~     two-treatment crossover pivotal bioequivalence (BE) evaluation of the DTG/ABC/3TC FDC tablet~     in 66 healthy subjects. The reference formulations in this trial will be the 50 mg DTG tablet~     that is currently being used in the Phase 3 clinical trials and the already marketed FDC~     tablet product EPZICOM™ (ABC 600 mg/3TC 300 mg).It is intended that the results of this~     pivotal bioequivalence study will show that the proposed commercial DTG/ABC/3TC FDC tablet~     formulation is bioequivalent to DTG plus EPZICOM administered as separate tablets. Part B of~     this study will evaluate the effect of a high fat meal on the FDC tablet in 12 healthy~     subjects that have already participated in Part A of the study. There will be a screening~     visit within 30 days prior to the first dose of study drug and a follow up visit within 7-14~     days after the last dose. There will be a 7 day washout between doses in each treatment~     period. The following PK parameters for DTG, ABC and 3TC will be measured: area under the~     concentration curve from time zero (pre-dose) extrapolated to infinite time~     (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the~     time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration~     (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of Cmax~     (tmax), terminal phase half-life (t½), terminal elimination phase rate constant (λz),~     percentage of AUC obtained by extrapolation (%AUCex),apparent clearance following oral dosing~     (CL/F) and apparent terminal phase volume~   "
148494|NCT01622777|"~     To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid~     peroxidation and nerve growth factor.~   "
148495|NCT01622764|"~     The research the investigators propose is a molecular imaging study of RO5323441, an antibody~     against placental growth factor (PlGF) in patients with recurrent GBM treated with~     bevacizumab, a drug against vascular endothelial growth factor (VEGF). Both VEGF and PlGF are~     molecules involved in tumor growth since they enable the development of tumor vasculature,~     thus delivery of oxygen and nutrients to the tumor. The treatment will consist of bevacizumab~     (i.v.) given every 2 weeks, until the patient has clinical benefit (no disease progression)~     or unacceptable toxicity. Meanwhile, patients will receive and injection of low protein-dose~     radiolabeled RO5323441 (89Zr-RO5323441) on day -3 and 11 of the first bevacizumab treatment~     cycle. Brain-only 89Zr-RO5323441 positron emission tomography (PET) will be performed at 2~     hours after each injection of 89Zr-RO5323441 on day -3 and 11. Whole body 89Zr-RO5323441 PET~     will be performed on day 1 and 15, before and after the first treatment with bevacizumab. The~     main purpose of this trial is to determine how much of RO5323441 actually gets into the~     recurrent GBM lesions, since for a drug to be active, it has to be able to reach cancer~     cells. As second aims, RO5323441 accumulation in normal, non-tumor organs, will be assessed,~     as well as how bevacizumab influences RO5323441 penetration into tumor lesions (to answer the~     question of combined bevacizumab + RO5323441 treatment in GBM) or RO5323441 biodistribution~     in non-tumor organs.~   "
148496|NCT01622751|"~     Context: Adiponectin is an adipose tissue-derived hormone with an insulin sensitizing effect,~     and has been related to obstructive sleep apnea syndrome. In addition, children with~     Prader-Willi syndrome (PWS) suffer from excessive daytime sleepiness and the abnormality of~     rapid eye movement (REM) sleep.~      Objective: To determine if the sleep stages are related to the plasma levels of adiponectin,~     resistin, and RBP4 (retinol binding protein-4), and whether these relationships are~     influenced by age, obesity and insulin resistance.~   "
148497|NCT01622725|"~     Since abdominal wall hernia repair is currently performed with the use of a mesh, side~     effects associated with the mesh are frequently reported during long term follow-up. These~     side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and~     inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh~     has been developed, which provides sufficient support and strength to allow efficient~     recovery of the abdominal wall, but also disappear from your body in three years time, so~     that you no longer have any synthetic material in your body. Previous resorbing meshes also~     disappeared but over a much shorter period of time, so that the hernia was insufficiently~     healed, with recurrence as a result.~      The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made~     of two commonly used polymers, however it will retain 50% of its initial strength after six~     months. This in theory is enough to provide support of the collagen healing process during~     the initial wound-healing phase, but also to support the transition of initial collagen to~     functional collagen.~      The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the~     anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias~     are not part of the study).~      Therefore the patients will be divided into two groups, one group will be treated with a~     resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will~     be no difference in the medication or the surgical techniques used.~   "
148498|NCT01622712|"~     The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol~     containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery,~     quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a~     multicenter (Belgian) prospective trial.~      Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia~     according the current surgical practice in the participating centers will be observed during~     one year post-surgery, after which they will have a CT scan of the surgical area in the groin~     to evaluate the mesh changes regarding shrinkage and migration.~   "
148499|NCT01622699|"~     Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns.~     Assessment of the degree of jaundice is usually done visually,and if necessary serum~     bilirubin is investigated in a blood sample. The visual assessment is subjective and can~     alternatively be replaced by transcutaneous measurement.The transcutaneous bilirubinometer is~     a validated measurement-tool, which provides us with an estimated serum~     bilirubin-concentration. Little is known about the effect of the actual use of a~     bilirubinometer on the quality of care. Further evidence is needed to evaluate whether~     transcutaneous bilirubin measurements improve clinical outcome (use of blood tests,~     phototherapy and exchange transfusion), shorten length of stay and reduce costs. Therefore we~     aim to perform a Randomized controlled trial to evaluate the cost-effectiveness of~     implementing the use of a transcutaneous bilirubinometer in jaundiced neonates, a gestational~     age of 32 weeks. The assessment of jaundice by use of a transcutaneous bilirubinometer is~     compared to visual assessment of jaundice~   "
152502|NCT01570205|"~     The objective of the study is to investigate safety, tolerability, and pharmacokinetics of~     XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to~     healthy male volunteers~   "
148501|NCT01622673|"~     This study will evaluate: (1) the effect of co-administration of single doses of calcium~     carbonate antacid and magnesium/aluminum hydroxide antacid on the steady-state plasma~     pharmacokinetic profile of raltegravir in human immunodeficiency virus (HIV)-infected~     participants; and (2) the effect of staggered dosing of a single dose of a magnesium/aluminum~     hydroxide antacid 2 hours before and 2 hours after administration of raltegravir on the~     steady-state plasma pharmacokinetic profile of raltegravir in the same participants.~      The study will determine whether (1) the C12hrs of steady-state raltegravir after~     co-administration of single doses of calcium carbonate antacid is decreased to a clinically~     meaningful degree compared with C12hrs after administration of raltegravir alone; and whether~     (2) the C12hrs of steady-state raltegravir after co-administration of a single dose of~     magnesium/aluminum hydroxide antacid is decreased to a clinically meaningful degree compared~     with the C12hrs after administration of raltegravir alone.~   "
148502|NCT01622660|"~     Gemcitabine and Cisplatin are standard chemotherapy drugs used to treat advanced urothelial~     cancer. There is no standard chemotherapy for patients who cannot receive Cisplatin. However,~     most patients are treated with the chemotherapy drugs Gemcitabine and Carboplatin.~      In this study, the researchers hope to learn what effects, good and/or bad, the combination~     of Gemcitabine and Pazopanib has on urothelial cancer. Gemcitabine is given intravenously~     (through the veins) and works by killing rapidly dividing cells in the body, including cancer~     cells. Pazopanib is an oral chemotherapy and works by decreasing the blood supply to tumors~     which limits the tumor's source of oxygen and nutrients.~      The combination of Gemcitabine and Pazopanib is being tested in research studies such as this~     one. As of August 2011, more than 18 patients with various types of cancer have received~     treatment with Gemcitabine and Pazopanib. The main goal of this clinical research study is to~     learn if the study drugs Gemcitabine and Pazopanib can shrink or slow the growth of~     urothelial cancer. The safety of this drug will also be studied. The physical state, changes~     in the size of the tumor, and laboratory findings will help us decide if the combination of~     Gemcitabine and Pazopanib is safe and effective.~   "
148503|NCT01622647|"~     The proposed study intends to investigate several aspects of the respiratory effects of~     intravenous sedation of patients undergoing spinal anesthesia for knee replacement surgery.~     The study will include assessment of PaCO2 during the intraoperative period. PaCO2 is~     expected to be elevated as a result of intravenous sedation and postural factors. Further,~     the study will investigate how application of Nasal Continuous Positive Airway Pressure~     (N-CPAP) may impact PaCO2.~   "
148504|NCT01622634|"~     The objective of this study is to determine the combined effects of a high-protein diet and~     high-intensity training on metabolic syndrome risk factors in women aged 30-65.~   "
148505|NCT01622621|"~     This randomized phase II trial is for medically inoperable early stage non-small cell lung~     cancer (NSCLC) patients. It is designed to compare the number of patients who are disease~     free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical~     intervention arms. SBRT is less invasive and felt to be equally effective to surgery for~     early stage NSCLC. Surgery is currently the standard of care for these patients. The~     hypothesis of this study is that SBRT is at least as good as surgery for disease free~     survival at 2 years.~   "
148506|NCT01622608|"~     The purpose of this study is to determine whether implementation of a web-based educational~     intervention using a vaccine information kiosk placed in primary care practice waiting~     rooms can reach a large number of parents and have a measurable impact on adolescent~     vaccination rates, specifically for Tdap, HPV, meningococcal, and influenza vaccines.~   "
148507|NCT01622595|"~     OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS~   "
148508|NCT01622582|"~     Engraftment Syndrome after Autologous Stem Cell Transplant: Retrospective Review in Patients~     with Multiple Myeloma~   "
148509|NCT01622569|"~     The primary objective of this study is to compare the efficacy of intranasal administration~     of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose~     device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will~     be used in the study: reduction of nasal congestion/obstruction symptoms at the end of Week 4~     of the double-blind treatment phase measured by the 7 day average instantaneous AM diary~     symptom scores, and reduction in total polyp grade (sum of scores from both nasal cavities)~     over the 16 weeks of the double-blind treatment phase as determined by the Lildholdt scale~     score measured by nasoendoscopy.~   "
148510|NCT01622556|"~     This is a phase II study to assess the day 180 event free and overall survival after~     administration of a specified combination of fludarabine, busulfan, Total Body Irradiation~     (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant~     in a single institution setting in patients with hematologic malignancies for whom allogeneic~     transplantation is indicated.~   "
148511|NCT01622543|"~     The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/~     bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab.~   "
148512|NCT01622530|"~     Amputees often choose not to wear prostheses due to marginal performance or may settle for a~     prosthesis that offers only cosmetic improvement, but lacks function. A simulation tool~     consisting of a robotics-based human body model (RHBM) to predict functional motions, and~     integrated modules for aid in prescription, training, comparative study, and determination of~     design parameters of upper extremity prostheses will be developed.~      The main objective of collecting and analyzing human movement during several common tasks is~     to optimize and validate the robotics based human model. The range of motion data of subjects~     performing activities of daily living such as opening a door, turning a wheel, grooming,~     eating, bilateral lifting, as well as recreational and sport activities such as swinging a~     baseball bat, and golf club will be analyzed. This motion analysis data will also be used to~     compare data between four groups: a control group (n=10), a braced group simulating~     prosthesis use (n=10), a group wearing a transradial prosthesis (n=10) and a group wearing a~     transhumeral prosthesis (n =10).~   "
148898|NCT01617499|"~     The aim of this pilot study is to evaluate the effects of a worksite wellness program on~     physical activity and cardiovascular disease risk factors among university employees. The~     investigators hypothesize that the proposed worksite wellness program will be effective for~     increasing daily physical activity and improving one or more cardiovascular disease risk~     factors among university employees.~   "
148513|NCT01622517|"~     The overall goal of the CTP to predict Response to recanalization in Ischemic Stroke Project~     (CRISP) is to develop a practical tool to identify acute stroke patients who are likely to~     benefit from endovascular therapy.~      The project has two main parts. During the first part, the investigators propose to develop a~     fully automated system (RAPID) for processing of CT Perfusion (CTP) images that will generate~     brain maps of the ischemic core and penumbra. There will be no patient enrollment in part one~     of this project.~      During the second part, the investigators aim to demonstrate that physicians in the emergency~     setting, with the aid of a fully automated CTP analysis program (RAPID), can accurately~     predict response to recanalization in stroke patients undergoing revascularization. To~     achieve this aim the investigators will conduct a prospective cohort study of 240 consecutive~     stroke patients who will undergo a CTP scan prior to endovascular therapy. The study will be~     conducted at four sites (Stanford University, St Luke's Hospital, University of Pittsburgh~     Medical Center, and Emory University/Grady Hospital). Patients will have an early follow-up~     MRI scan within 12+/-6 hours to assess reperfusion and a late follow-up MRI scan at day 5 to~     determine the final infarct.~   "
148514|NCT01622504|"~     This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie~     nasal spray (Test Product) and as a solution for injection (Comparator Product) administered~     intranasally using a mucosal atomization device (MAD).~   "
148515|NCT01622491|"~     Excellent immune responses following 1 or 2 doses of the GSK monovalent AS03-adjuvanted~     pandemic H1N1 (pH1N1) vaccines (e.g., Arepanrix®) have been documented in several trials.~     Observational studies have found that these vaccines were effective in preventing laboratory~     confirmed influenza infections. However, it remains unclear whether vaccination during the~     pandemic was associated with reductions in more clinically meaningful outcomes, such as~     hospitalizations, severe illness, complications, and death.~      The investigators propose to evaluate the effectiveness of the GSK adjuvanted and~     non-adjuvanted pH1N1 vaccines used in Manitoba in preventing hospitalization and severe~     illness (defined as illness necessitating admission to intensive care or associated with~     major complications) due to influenza or pneumonia by means of a case-control study using~     data from Manitoba Health (MH) administrative databases and the database of the Cadham~     Provincial Laboratory. The primary outcome will be hospitalization with laboratory-confirmed~     influenza or pneumonia. A secondary outcome will be hospitalization with influenza or~     pneumonia. The investigators will also assess the effectiveness of the above vaccines for~     different age groups and among high-risk populations, e.g., immunocompromised individuals.~   "
148516|NCT01622478|"~     Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently~     debatable. It is possible that the tumor response to chemotherapy may alter the lymphatic~     drainage thus causing lower SLN identification rate and higher false negative rate. Further,~     the response of NAC can be different in each lymph nodes. It is doubtful whether SLNB can~     accurately predict axillary lymph node (ALN) status after NAC. The aim of this study to~     determine the identification rate, the false-negative rate, and the accuracy of SLNB after~     NAC for node positive breast cancer.~   "
148517|NCT01622465|"~     The aim of this study is to evaluate the effects of an exercise program with a cycle~     ergometer in functional outcome and related-health quality of life (RHQL) in elderly patients~     with total hip arthroplasty.~   "
148518|NCT01622452|"~     Postoperative cognitive decline (POCD) is a frequent complication after cardiac surgery. It~     is estimated that 40-70% of all cardiac patients show cognitive dysfunction during the first~     post-surgical week. Six weeks after surgery, this incidence decreases to 10-40% and the~     figure remains stable over the long-term.~      The investigators will recruit 50 patients undergoing elective valve surgery and each patient~     will receive complete evaluation a) preoperative, one week before surgery; b) early~     postoperative, before hospital discharge; and c) late postoperative, 8 weeks follow up.~      The investigators will apply Diffusion Tensor Imaging, 1Proton-Magnetic Resonance~     Spectroscopy and Morphometry studies with correlation to neuropsychological test battery to~     evaluate POCD.~   "
148519|NCT01622439|"~     Patients with previously untreated diffuse large B-cell lymphoma will receive standard~     treatment with R-CHOP (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison)~     for 6 cycles, cycle length is 14 or 21 days. In addition, valproate is given three times~     daily day 1-3 in escalated doses. The rationale for adding valproate to standard treatment is~     invitro data indicating a sensitizing effect to chemotherapy, and an increase in CD~     20-expression.~      Patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels~     are 30, 60, 80, 100, 120, 140 mg/kg/day. A total of 20 patients will be treated at the MTD.~   "
148520|NCT01622426|"~     The investigators aim to assess the tolerance to a new commercially available Aaf in children~     affected by IgE- or non-IgE-mediated CMA.~   "
148521|NCT01622413|"~     This study compares an endoscopic transforaminal surgical technique for the treatment of a~     herniated disc to the standard microsurgical procedure. Clinical parameters as well as health~     economy will be assessed.~      The study hypothesis is that the endoscopic approach is equivalent or superior to~     microdiscectomy.~   "
148522|NCT01622400|"~     A dedicated therapeutic education program is an essential tool in the management of~     hypertension as well as in the control of other cardiovascular risk factors. The purpose of~     this study is therefore to evaluate the effect of such a therapeutic education program in~     general practice patients at high cardiovascular risk.~   "
148523|NCT01622387|"~     During coronary bypass surgery, veins are taken from the leg and applied to the heart and~     aorta to 'bypass' narrowings in the coronary arteries. However using an artery in the chest,~     the internal mammary artery, means that the bypass lasts longer than using veins. The~     investigators recently showed that using an artery from the arm as a bypass vessel, the~     radial artery, also had less furring up than veins 5 years after surgery. Now the~     investigators would like to ask patients to come back for an angiogram 10 years following~     surgery.~   "
148524|NCT01622374|"~     To examine the pre-operative effect of music for the mind compared to some other styles of~     music in patients undergoing dental procedures.~   "
148525|NCT01622361|"~     The purpose of this study is to compare neo-adjuvant therapy of cytotoxic chemotherapy versus~     GnRHa with tamoxifen , of response rate(RR) in patients of hormone responsive and HER2~     negative, lymph node positive, primary breast cancer in premenopausal women.~   "
196271|NCT00994305|"~     Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of~     deceased renal transplant patients.~   "
148529|NCT01622309|"~     Cardiovascular diseases (CVD) prevail as the main cause of death in developed and developing~     countries and are among the most frequent causes of disabilities in Brazil and in the world.~      Economic alternatives have been studied to assist in reducing cardiovascular risk factors.~     Within this context, the Solanum menogena, whose fruit known as eggplant is widely consumed~     in Brazil, is being used in alternative medicine with the purpose to reduce the~     concentrations of cholesterol, glucose and promote loss of body weight.~      Aubergine (eggplant) stands out for its high fibre content (approximately 40%) and low fat~     content. In addition, it is popularly known for its functional properties, aiding in reducing~     the risk of coronary diseases. The purplish coloring of the eggplant peel is attributed to~     the large amount of flavonoids, which have antioxidant properties and contribute to the~     flavor of eggplant.~      The investigators hypothesis is that the eggplant flour associated with a restricted calorie~     diet has effect in reduction in waist circumference, reduction of body fat and increasing~     HDL-cholesterol; this way, contributing to the reduction of cardiovascular risk factors~      All participants will be informed about the research and they will have to sign a consent~     form. The volunteers will be divided into two groups: one group will receive a~     restricted-calorie diet and supplementation with eggplant flour; and the other will receive a~     diet plus a placebo for 120 days, being both groups evaluated monthly. In each consultation,~     evaluation of weight, body composition, fulfillment of the diet and blood pressure~     measurement will be performed. In addition, blood will also be collected in order to~     determine glucose, insulin, total cholesterol, LDL, HDL, triglycerides, oxidized anti-LDL~     antibodies, 15-isoprostane and minerals (selenium, zinc, iron, manganese, magnesium and~     copper). The results will be analyzed by statistical program.~      The investigators expect that with the results obtained, the eggplant flour can be used as an~     ally in the prevention of cardiovascular diseases.~   "
148530|NCT01622296|"~     The purpose of this study is to determine the effectiveness of buffered local anesthesia~     injections to numb the gums and teeth during dental treatment. Adjusting the pH of lidocaine~     with sodium bicarbonate may reduce the pain of injection for both adults and children. In~     this study, the investigators will compare two local anesthetic preparations, a buffered~     anesthetic and the conventionally available anesthetic, for pain upon injection.~      Hypothesis: Anesthetic buffered to physiologic pH will result in a less painful injection~     compared to the acidic alternative used in most dental offices. This can be demonstrated by~     comparing two local anesthetic preparations, a buffered anesthetic and the conventionally~     available anesthetic, for pain upon injection.~   "
148531|NCT01622283|"~     This study will be a single center, open-label, randomized, single dose, in the fasted~     condition and 2-way crossover study to evaluate the pharmacokinetics, the safety and~     tolerability of levocetirizine oral solution 5 mg and cetirizine dry syrup 10 mg in Japanese~     healthy male subjects.~      Approximately 20 subjects will receive both treatments of levocetirizine oral solution 5 mg~     and cetirizine dry syrup 10 mg in the design. Serial pharmacokinetic samples will be~     collected and safety assessments will be performed following each dose.~      The primary objective of the study is to demonstrate the bioequivalence of levocetirizine in~     plasma, when given as levocetirizine oral solution 5 mg relative to cetirizine DS 10 mg in~     Japanese healthy male subjects.~   "
148532|NCT01622270|"~     The objective of this study is to investigate the changes in crohn on resting energy~     expenditure.~   "
148533|NCT01622257|"~     The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin~     or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding~     clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid~     profile.~   "
148534|NCT01622244|"~     The study will assess the effectiveness and cost-effectiveness of providing brief, intensive~     case management for frequent users of hospital Emergency Departments who have mental health~     and/or addictions problems. The goals of the intervention are to support patients' transition~     to community-based health and social services and supports - including primary and urgent~     psychiatric care, peer support and other community services and supports - so as to improve~     patient wellbeing and reduce avoidable ED visits and hospitalizations.~   "
148535|NCT01622231|"~     Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese~     paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will be evaluated.~     And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray~     over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with perennial~     allergic rhinitis will also be evaluated.~   "
148536|NCT01622218|"~     The purpose of our study to quantitatively examine the stress levels prior to surgery and the~     use of analgesics post surgery in both children and their parents following a preoperative~     intervention with a medical clown compared to children that were not exposed to this~     intervention.~   "
148537|NCT01622205|"~     Stroke is a generic term for cerebral infarction and cerebral haemorrhage and accounts for~     more patient days than any other single condition in Swedish health care. The Swedish~     guidelines for stroke treatment, issued by the national board for health and welfare,~     recommend early supported discharge for people with mild to moderate stroke. This is based on~     studies in which mean hospitalization was 18 days. The average length of stay in Sweden is 12~     days. Policy makers would, however, like to shorten length of stay even further, and many~     patients are anxious to get home. Where and how to get support at home after discharge~     varies.~      This study is a randomized controlled trial in which half of the subjects are randomly~     allocated to very early supported discharge and the other half receives usual treatment. The~     investigators believe that patients discharged very early with support will experience less~     anxiety compared with controls. The investigators believe that early supported discharge is~     safe and that there is no difference between groups in bodily function. In order to test~     differences between the groups, the study requires approximately 110 subjects.~      Everyone who comes to the stroke unit at the hospital with a mild to moderate stroke can be~     recruited to the study. The intervention is having a team from the stroke unit visiting the~     patient's home and train him/her according to the individualized goals. The controls are~     discharged according to routine with support from primary care if needed. Assessments are~     made by therapists who are not involved in the training upon returning home, at 1 month, 3 to~     12 months. The assessments include anxiety, motor activity, gait and balance, and ADL.~     Interviews will be done to highlight the subject's own experience.~      It is important to evaluate new methods and organizational changes prior to their~     implementation in health care. The investigators hope to show that very early supported~     discharge with rehabilitation is safe and provides confidence and less anxiety. Then it is~     possible to introduce a method that simultaneously improves patient outcome and increases~     availability of hospital beds.~   "
148538|NCT01622192|"~     The aim of the study is to determine the best method for measuring the extent and severity of~     the gum disease by comparing the repeatability of probing depths achieved by a manual probe~     when compared to an automated probe.~      Hypothesis~      The null hypothesis to be tested includes~        -  The automated probe does not improve the reproducibility of periodontal probing when~          compared to manual probing recordings~        -  The automated probe shows no advantage when comparing the reproducibility of~             -  Moderate sites~             -  Deep sites~             -  Single vs. multirooted teeth~             -  Different sextants~             -  Different surfaces of teeth Buccal vs. palatal/lingual Mesial vs. mid vs. distal~   "
148539|NCT01622179|"~     The purpose of this study is to estimate the effective of two suture methods in the treatment~     of Achilles rupture.~   "
156678|NCT01515371|"~     The purpose of this study is to identify out of up to three doses a safe and effective dose~     of Botulinum toxin type A for an injection into one side of the soft palate to treat snoring.~   "
148540|NCT01622166|"~     Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic~     art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of~     schizophrenia compared to a group of patients receiving treatment as usual.~      *Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission~     compared to TAU.~      *Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing~     function, self-efficacy and neuroleptic dosage compared to TAU.~   "
148541|NCT01622153|"~     1. The investigator hypothesize that the Laser pulpotomy will provide adequate and~          comparable success clinically in primary molars.~        2. The investigators hypothesize that the Laser pulpotomy will provide adequate and~          comparable success radiographically in primary molars.~   "
148542|NCT01622140|"~     This is a prospective cohort study of persons tested for latent tuberculosis infection at~     either high risk for exposure to Mycobacterium tuberculosis or high risk for progression to~     tuberculosis disease. The study will assess the relative performance and cost of three~     diagnostic tests for latent tuberculosis infection (tuberculin skin test, QuantiFERON-TB Gold~     In-Tube, and T-SPOT.TB) and will examine the rates of positive results among the cohort. This~     study will also determine the risk and rate of progression to active TB disease, overall and~     by the results of the three tests.~   "
148543|NCT01622127|"~     A novel concept of self-gripping mesh has been developed to achieve secure and long-term~     posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament~     polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which~     provide self-gripping properties during the first few months after implantation. The~     self-fixation of the mesh to the underlying tissues is instantly achieved at application,~     limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and~     damage cutaneous nerves), and providing a near tension-¬free repair.~      Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and~     painless treatment of incisional hernias and provides secure and efficient fixation mesh. On~     this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional~     hernia defect treatment. In order to assess the clinical outcomes following the use of~     ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has~     been initiated.~   "
148544|NCT01622114|"~     Achievement and maintenance of weight loss in obese individuals has proven difficult. Many~     hypotheses have suggested potential biological mechanisms to explain why weight loss attempts~     often fail, and the surrounding obesogenic environment also seems an obvious candidate. Among~     the biological factors proposed is gender, and weight loss trials have frequently shown that~     females are less successful than males at losing weight and at maintaining weight loss.~      Women's weight is influenced by the menstrual cycle, in which changes in hormonal levels and~     interactions work to modulate fertility. These hormones control the menstrual cycle and~     coordinate the required changes in energy intake, expenditure, and storage, whilst preparing~     the body for pregnancy every month. As reproduction is a primary biological function, these~     hormones may be such strong mediators of eating behavior that they influence the outcome of a~     weight loss attempt. The menstrual cycle should therefore be taken into consideration as a~     factor in the physiology of energy balance in premenopausal women.~      The cycle can be divided into three phases: menstruation or early follicular phase (days~     1-5), late follicular phase that lasts until ovulation (~days 6-14, and the luteal phase~     (days 15-28).~      Studies have shown that in the luteal phase of the menstrual cycle, women's energy intake and~     energy expenditure are increased and women experience more frequent cravings for foods,~     particularly those high in carbohydrate and fat, than during the follicular phase. A trend~     towards reduced carbohydrate utilization and increased fat oxidation in the luteal phase has~     also been reported, together with prolonged time to exhaustion when exercising at submaximal~     intensities. This suggests that the potential of the underlying physiology related to each~     phase of the menstrual cycle may be worth considering as an element in strategies to optimize~     weight loss.~      In 2010 the investigators carried out a 90-day randomized, controlled pilot study in order to~     gain feedback on and assess acceptance of the meal and exercise plans being used and to~     observe if less control visits than planed in the main study were sufficient to achieve good~     compliance. Twenty eight were sreened and 24 were included. Subjects were randomized to~     either program A (given meal and exercise plans in relation to phases of their menstrual~     cycles) or Program B (a reduced calorie diet, calorie-matched to program A). The pilot study~     showed that Group A (The Menstralean group) tended to have a greater average weight loss at~     60 days (-5.29 vs -3.57 kg, p = 0.06) and 90 days (-4.22 vs -2.75 kgs, p = 0.2) compared to~     the control groups. There was a dropout rate of 27%. This was primarily due to an inadequate~     number of control visits and contact with the subjects. Thus the Menstralean program seems to~     have the potential to enhance weight loss in overweight and obese women. However, the main~     study has to be carried out with more subjects in each group in a longer duration and with~     more support and contact with the subjects.~      The aim of the present trial is to examine the impact of the menstrual cycle on weight loss~     attempts in healthy overweight (BMI > 27 kg/m2) premenopausal women (18-40 years) randomized~     to two different weight management programs for a period of 6 months.~   "
148545|NCT01622101|"~     Background: Zantrex-3® is a popular dietary supplement for weight control, which consists of~     a combination of yerba mate, guarana, caffeine and damiana. The combination has previously~     been shown to decrease gastric emptying and its weight controlling effects may be related to~     increased satiety and thermogenesis.~      Objective: To investigate the effect of Zantrex-3® on energy expenditure, hemodynamic factors~     and subjective appetite sensations.~      Design: Twenty-three men (BMI: 23.9±3.2 kg/m2, mean±SD) participated in a randomized,~     double-blind, placebo-controlled crossover study. The Zantrex-3® compound contained 365 mg~     xantines (caffeine and caffeine-like stimulants), yerba mate, guarana and damiana. The~     thermogenic effect was measured for 3 hours post-intake. Blood pressure (BP), heart rate (HR)~     and appetite ratings were assessed every half hour.~   "
148546|NCT01622088|"~     The purpose of the study is to collect long-term safety data from subjects with Amyotrophic~     Lateral Sclerosis (ALS) exposed to dexpramipexole.~   "
148547|NCT01622075|"~     The purpose of this study is to evaluate the efficacy and safety of successful interventional~     therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent~     restenosis by paclitaxel -eluting PTCA- balloon catheter (3μg/mm2 balloon surface area)~     versus paclitaxel-eluting stent Taxus® Liberte, and the reference diameter of coronary artery~     stenosis is 2.5mm-4.0mm and the length ≤30mm.~   "
148548|NCT01622062|"~     The purpose of this study is to assess the 4-site one-week post-exposure prophylaxis (PEP)~     regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen.~      Primary objective:~        -  To demonstrate that PEP using the new one-week, 4-site (4-4-4-0-0) intradermal (ID)~          vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID~          vaccination regimen.~      Secondary objectives:~        -  Primary immunization: To describe the immune response in each group at Day 0, Day 14 and~          Day 90.~        -  Antibody persistence: To describe rabies virus-neutralizing antibody persistence during~          the 5 years after completion of PEP in each group.~        -  Booster vaccination: To describe the immune response induced by a single-visit 4-site~          intradermal booster vaccination in each group at Year 5.~        -  Safety: To describe the safety profile of each group after the primary and booster~          vaccinations.~   "
148549|NCT01622049|"~     Patients undergo a detailed ultrasound examination to rule out the presence of congenital~     anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS~     will be considered candidates for the trial. Patients will be counseled about the risks and~     benefits of all treatment options and will be free to choose any treatment option. They will~     then be asked to sign an informed consent. The procedure will be performed under local~     anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be~     introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be~     located endoscopically and will be lasered with YAG laser energy. An accessory port may be~     required in some cases. The procedure will be monitored both endoscopically and~     sonographically. The presence of fetal heart activity will be noted often during the~     procedure. An amniodrainage of the larger sac may be performed at the time of the procedure.~     The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on~     the first post operative day. Patients will undergo a weekly ultrasound examination for four~     weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will~     include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders,~     absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein,~     ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their~     corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive~     care unit will be followed through their discharge. Evidence of neurological or cardiac~     morbidity will be sought in each twin. If either of these complications is suspected,~     evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be~     followed up for neonatal, infant and childhood morbidity or mortality. It is requested that~     all placentas be delivered fresh to Tampa General Hospital in an icebox container for~     assessment. Placentas will be discarded after analysis.~   "
148638|NCT01620892|"~     The study seeks to evaluate the condition of patients 5 years after having undergone partial~     knee replacement for localized osteoarthritis of the knee. Participating patients will~     voluntarily undergo detailed evaluation of clinical and radiologic outcomes 5 years after~     surgery. The aims of the study are to describe the survivorship of the prostheses and the~     clinical results of patients, and to elucidate and describe the natural history disease of~     the untreated knee joint compartments after a partial replacement. Patients who were operated~     by the principal investigator 5 years previously will be invited to participate. The study is~     observational in nature; there is no element of experimentation or test of an intervention.~   "
148550|NCT01622036|"~     It is estimated that up to 30% of cancer patients die because of the effects of malnutrition,~     caused by a discrepancy between nutritional needs and intake (or utilization) of energy and~     essential nutrients. Malnutrition and its severe complication, cancer cachexia, are negative~     prognostic factors in neoplastic patients, inducing Decreased response and tolerance to~     antineoplastic treatments, decline in the functional status, reduced quality of life and~     reduced survival. Prevalence data on malnutrition in italian oncology patients are lacking~     and the available literature data on weight loss and malnutrition in oncology refer to~     patients in different phases of disease and therapy. Most importantly , strategies for~     prevention of malnutrition and cachexia in oncology are still largely disregarded and~     scarcely implemented.~      The main objective of this project is to assess the prevalence of malnutrition in patients~     undergoing first medical oncology visit in Italy. Secondary objective is to increase~     awareness of metabolic and nutritional issues among medical oncologists, thus favoring the~     inclusion of metabolic-nutritional screening and monitoring in medical oncology protocols.~     This would in turn contribute to reduce the negative consequences of malnutrition- and~     cachexia-related complications.~   "
148551|NCT01622023|"~     The aim of the present study is to prospectively evaluate whether performing an intra-uterine~     insemination 24 hours after the spontaneous LH peak may result in significantly higher~     ongoing pregnancy rates compared to 48 hours.~   "
148552|NCT01622010|"~     The purpose of this research is to determine if there is a greater behaviour change in self~     management of heart failure following reinforced multimedia education focusing on physical~     activity as compared to standard care. It is the investigators belief that participants who~     receive DVD education in addition to usual care will show improved self management in~     comparison to receiving usual care alone. The investigators anticipate fewer hospital~     admissions due to improved self care management.~   "
148553|NCT01621997|"~     To examine whether retraining via operation inspection or verbal education can reduce the~     risk for peritonitis in PD patients.~   "
148554|NCT01621984|"~     The purpose of this current prospective study is to assess the effects of a Therapeutic~     Riding exercise program conducted in patients suffering from neuromuscular disease. The~     exercise intervention aims at improving gross motor function, gross motor performance,~     balance, spasticity, posture and quality of life. Patients were randomized according to age,~     sex, mental ability and gross motor function. Furthermore, patients will be subdivided into~     categories of central nervous system (brain/ spinal cord) and peripheral (peripheral nerve or~     muscle) diseases. The exercise program duration will be 12 weeks, once a week with 30-40~     minutes sessions. Six measurements will be conducted: the Gross Motor Function Measure, the~     Gross Motor Performance Measure, the Quality of life Questionnaire for Children, the~     Pediatric Balance Scale, the dynamic plate in combination with x-ray for posture control, the~     Modified Ashworth Scale for spasticity and the Wisc 3 for mental ability. The results will be~     collected and evaluated using the statistical programme SPSS.~   "
148555|NCT01621971|"~     Our main hypothesis is that inhalation of milrinone can reduce the elevated pulmonary~     arterial pressure due to severe mitral valve regurgitation without compromising systemic~     hemodynamics. Therefore, the effects of a brief inhaled milrinone (IH) on pulmonary artery~     pressure are determined and compared to those of intravenous milrinone (IV) in severe mitral~     regurgitation patients undergoing mitral valve surgery.~   "
148556|NCT01621958|"~     Slip-related falls often cause injury; these often have catastrophic consequences, even among~     the healthiest older persons. Establishing a retainable preventive training regimen against~     slip-related falls would, without doubt, have major public health implications. In this~     study, investigators will demonstrate that older adults can significantly reduce their~     near-term risk of backward balance loss and falls through motor training with multiple~     protected slip exposure, and such adaptive improvements from such prophylactic training~     regimen can be retained over the course of a year.~   "
148557|NCT01621945|"~     The main objective of the study is to estimate the proportion of children, born between the~     06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with~     a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4),~     before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.~   "
148558|NCT01621932|"~     Randomized prospective study comparing the anterior capsule repair vs capsulectomy with~     regards to post-operative pain and range of motion outcomes in elective primary unilateral~     direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded~     for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by~     goniometer measurements and lateral hip radiographs in maximum flexion.~      The purpose of the study is to compare post-operative pain control and hip range of motion~     between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during~     direct anterior total hip arthroplasty.~   "
148559|NCT01621919|"~     S-1 has been also shown to be an effective drug for palliative chemotherapy in Eastern and~     Western GC patients. Recently, some case and small-sized studies have been reported on~     lacrimal drainage obstruction(LDO)caused by S-1.Suggested mechanism of LDO involves direct~     secretion of S-1 into the tear; thus the concentration of S-1 metabolite in tear is expected~     to be high in patients who developed LDO than in patients without LDO. We investigate the~     concentration of S-1 and its metabolites in tear and plasma and find out its correlation with~     side effects such as LDO. These results will also help us identify patients who are at high~     risk of developing S-1-associated side effects.~   "
148574|NCT01621724|"~     WT1 TCR gene therapy is a new treatment for acute myeloid leukaemia and chronic myeloid~     leukaemia.~      Patient's white blood cells (T cells) are modified to specifically fight the leukaemia cells~     by transferring a gene into the T cells, which allows them to recognize fragments of a~     protein called WT1. This protein is present on the surface of leukaemia cells at very high~     levels. The gene transferred to the T cells enables them to make a new T cell receptor (TCR),~     which will allow them to attack leukaemia cells with high levels of WT1 on their surface.~      Using this form of gene therapy the investigators can convert some of the patient's immune~     system's own T cells into T cells that the investigators hope will be much more effective at~     recognizing and killing leukaemia cells.~   "
148575|NCT01621711|"~     This component of a larger Center of Research Excellence Grant improves treatment for drug~     abuse by developing effective linkages between specialty drug treatment and primary health~     care.~   "
148560|NCT01621906|"~     The purpose of this study is to compare two different imaging methods to examine the response~     of brain metastases to WBRT. These two imaging methods will take pictures of the brain using~     : 1) a positron emission tomography (PET) scanner and 2) Magnetic Resonance Imaging (MRI)~     scanner. A PET scanner resembles a CT or MR scanner.PET scans use radioactive substances also~     called as radioactive markers to see cancer cells. We plan to use [18F]FLT as a radioactive~     marker. FLT is used to image tumor growth. FLT PET scan is a new clinical procedure. It is in~     the testing stage of development unlike FDG-PET which is used more commonly used. Therefore,~     this is considered a research study. This will help us evaluate whether this scan will be~     safe and better used in the future to evaluate tumors. The amount of radiation to the body is~     small. The radiation from the radiotracer drug will be gone from the body in a few hours.~     There is no radiation risk from the MRI scans. Additionally, we also plan to use MRI imaging~     of the brain. We expect that [18F]FLT PET is better when compared to MRI and will give us~     more information about the brain metastases after WBRT.~   "
148561|NCT01621893|"~     Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty~     procedure including changes in pain, function, and overall health.~   "
148562|NCT01621880|"~     Bevacizumab may have a better effect on brain necrosis caused by radiotherapy.This randomized~     trial aims to investigate whether bevacizumab may alleviate radiation-induced brain necrosis~     in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in~     patients receiving steroid therapy.~   "
148563|NCT01621867|"~     Cystic fibrosis is a genetic condition where epithelial cells, including from the respiratory~     tract, have an abnormal function of a surface protein, the cystic fibrosis transmembrane~     conductance regulator (CFTR) protein resulting from abnormal gene expression. The trial will~     assess the clinical efficacy, safety & tolerability and gene expression following repeated~     nebulised doses of a gene product coding for a normal CFTR protein, with the primary outcome~     of the trial assessing lung function.~   "
148564|NCT01621854|"~     This is a two-part Phase I, open label, dose-escalation, study of NUC-1031 as a single agent~     in patients with advanced solid tumours who have failed to respond to or who have relapsed~     after treatment with standard therapy. NUC-1031 is a ProTide of gemcitabine, a drug that has~     been used widely and effectively against cancers for many years. Both NUC-1031 and~     gemcitabine work by preventing cancer cells from dividing by attacking their DNA~     (deoxyribonucleic acid). Non clinical studies have shown that NUC-1031 is more effective than~     gemcitabine because it is able to reach cancer cells by passive diffusion, is less easily~     degraded by the cancer cell, and delivers the monophosphate form of the active agent. The~     first part of the study is to determine recommended phase 2 dose by dose escalation and the~     second part is to explore preliminary anti-tumour activity.~   "
148565|NCT01621841|"~     Glaucoma is a neurodegenerative disease representing the second cause of blindness worldwide.~     IOP (Intra occular pressure) is the most common risk factor, but not the only one as it is~     observed for normal tension glaucoma. Some studies have reported lesions of the optical~     pathways on MRI examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), by increasing~     spatial resolution and DTI (diffusion tensor Imaging)with fractional anisotropy could help us~     to analyze visual pathways and to determine the association with neurodegenerative diseases~     as Alzheimer.~      The investigators propose to compare volume and structure of the visual pathways between~     glaucoma patients and healthy subjects matched on age and sex.~      Glaucoma is a neurodegenerative disease characterized by loss of retinal ganglion cells,~     visual field deterioration and optic nerve cupping. Some studies have suggested that all the~     visual pathways could be damaged in glaucoma. Recently, a German study proved a significant~     reduction of volume of the optic radiations in glaucoma versus healthy subjects in MRI 3T.~     Some authors have also suggested that glaucoma could share similarities with the other~     neurodegenerative diseases like Alzheimer's disease. MRI 3T and DTI allow studying visual~     pathways with a high level of spatial resolution.Fractional anisotropy is a tag of~     microstructure.~   "
148566|NCT01621828|"~     The aim of this study is to investigate a possible reduction in pre-operative anxiety in~     patients undergoing major elective surgery, by providing multimedia information regarding the~     patient pathway to and from the Operating Theatre.~   "
148567|NCT01621815|"~     As the use of video games (VG) is rapidly increasing, many studies have tries to understand~     the effects of VG on the children and adolescents playing them.~      Most of the research was directed towards negative effects (especially violence, attention~     and school performance), producing mixed results.~      Recently, more studies had focused their attention on the opposite angle: The influence of~     the player's mental and behavioral parameters, influencing his VG playing patterns. The focus~     of most of these researches was time of playing, addictive patterns and exposure to violence.~      The current study will try to characterize the variance of VG playing pattern among~     adolescents diagnosed with psychiatric disorders, in order to better under the rich~     interaction between a player and his VG, and to understand whether VG playing patterns holds~     diagnostical clues for the child's diagnosis and his inner world.~   "
148568|NCT01621802|"~     The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®)~     in the US by generating immunogenicity and safety data in contrast to the US standard of~     care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six~     years of age.~   "
148569|NCT01621789|"~     Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during~     cataract phacoemulsification.~   "
148570|NCT01621776|"~     This study aims to compare the post-meal blood glucose values of two drugs in a real-world‟~     setting.~   "
148571|NCT01621763|"~     To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's~     formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation~     (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fed conditions and to~     assess the bioequivalence.~   "
148572|NCT01621750|"~     To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's~     formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation~     (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fasting conditions and~     to assess the bioequivalence.~   "
148573|NCT01621737|"~     The objective of the study is to compare the efficacy of intranasal oxytocin versus~     intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms~     despite being on adequate treatment with antipsychotic medication.~   "
148576|NCT01621698|"~     This project involves looking at the timing of providing pain relief for patients who are~     having lung surgery via the use of a small camera inserted into the chest with a scope (Video~     assisted thorascopy). This procedure can be the source of intense pain both immediately after~     the procedure and in the longer term leading to chronic pain problems.~      Local anaesthetic placed in the paravertebral space which is located adjacent to the spinal~     column, where the pain nerve fibres are located, is a well recognized method of providing~     pain relief for these procedures. It is currently unclear as to the best timings for~     providing this type of pain relief with some centres placing the local anaesthetic at the~     start of the procedure and some at the end. Placing a high volume of local anaesthetic into~     this area at the start of the case may provide better short and long term pain relief than~     placing it at the end of the procedure. The investigators hope to show a difference between~     the two timings to allow for better pain relief for these procedures. This would be a~     feasibility study that would lead onto a multicentre trial to eventually create a best~     practice protocol for pain relief for lung resection via this surgical method.~   "
148577|NCT01621685|"~     In 2004, the investigators initiated a human Capsaicin inhalation experiment under an~     Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject~     safety procedures instituted and approved by the Institutional Review Board (IRB). As part of~     the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid~     chromatography (HPLC). The investigation employed safety procedures while conducting the~     human inhalation investigations. In addition, during our investigations we observed~     discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist~     and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin~     solutions stored over a seven month period and refrigerated at 4degrees C and protected~     against ultraviolet light were examined.~   "
148578|NCT01621672|"~     The purpose of this study is to determine in a phase II trial, whether further maintenance~     therapy with Revlimid can extend the duration of progression-free survival and the duration~     of complete or near complete response compared to no further therapy beyond the TT3~     protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years~     with VTD (2003-33) or VRD (2006-66).~   "
148579|NCT01621659|"~     People with breast cancer and lymphoma often experience many short and long-term side effects~     as a result of both the cancer and the necessary treatments.~      Receiving extra assessments and care from teams of multiple health professionals has been~     shown to be helpful for people with other health problems, such as heart disease. These~     'multidisciplinary' teams may include nurses, doctors, pharmacists, dietitians, exercise~     therapists, counselors, and other specialists. Currently, the investigators do not know if~     receiving extra assessments from a multidisciplinary team is helpful for people receiving~     cancer treatment.~      In this study, the investigators hope to learn the effect of extra assessments and early~     interventions from teams of health care professionals in people diagnosed with cancer, during~     and after the treatment period.~      After initial assessments, participants will be randomized to multidisciplinary team~     intervention or usual care.~   "
148580|NCT01621646|"~     Cognitive impairment is also a major risk factor for development of dementia later in life.~     Findings from our studies suggest that the carotenoids, lutein and zeaxanthin may be~     important in cognitive function in the elderly. The investigators have previously reported~     eggs to be a highly bioavailable source of lutein and zeaxanthin. Our study evaluates~     long-term egg intervention as a treatment strategy for age-related cognitive impairment which~     could possibly prevent the onset of dementia. The investigators have also shown that lutein~     supplementation significantly improved verbal fluency scores in healthy older women. Our~     studies have shown that egg interventions can significantly increase serum lutein~     concentrations in older adults. Based on the sum of our findings, the next logical step will~     be to investigate the ability of lutein and zeaxanthin contained in eggs to influence~     cognitive function in older adults. The investigators hypothesize that there will be a~     significant increase in cognitive function measures in older adults provided with meals~     containing 2 egg/day at the end of 6 months, while no significant improvements will be~     observed in older adults given daily meals containing egg substitute.~      The proposed study is designed as a randomized, placebo controlled trial that tests the~     effects of 6 month supplementation with 2 eggs/day on cognitive function in older adults.~     Secondary analyses will determine whether baseline MP density predicts relative effectiveness~     of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of~     oxidative stress and inflammation.~   "
148581|NCT01621633|"~     This is a study to characterize the pharmacokinetics as well as safety and tolerability of a~     single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment~     compared to matched healthy subjects~   "
148582|NCT01621620|"~     objectives~        1. To study the sympatho-vagal balance effect on different limbs of pain perception.~        2. To determine whether it is the hypertension by itself or the baroreflex activation due~          to blood pressure rise that is responsible for the analgesic effect of acute~          hypertension.~      study questions~      The study questions are derived from the study objectives:~        1. Does sympatho-vagal balance influence pain perception?~        2. Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?~        3. Does sympatho-vagal balance influence temporal summation?~        4. Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex~          activation?~   "
148590|NCT01621516|"~     Under chronic immunosuppressive and corticosteroid therapy, transplant patients have a~     tendency to develop in the long-term diabetes. Patients who have received extra pancreatic~     tissue with their liver and small bowel transplantation have not yet developed insulin~     resistance or diabetes mellitus. We would like to investigate to which level insulin~     secretory capacity the extra pancreas together with the native pancreas has in these~     transplant patients using the hyperglycemic clamp. These data will be compared with the data~     obtained from healthy controls.~   "
148591|NCT01621503|"~     The primary objective of this clinical study is to collect clinical data to support an FDA~     510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary objective~     is to evaluate any adverse events found during the clinical study.~   "
148592|NCT01621490|"~     The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab~     in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood~     and tumor tissues of subjects with advanced melanoma (unresectable or advanced)~   "
148583|NCT01621607|"~     Background:~      - The risk for becoming addicted to drugs varies among individual, even those using similar~     drugs in a similar way. It is not known why some people become addicted and others do not.~     Studies suggest that some genes may increase the risk of addiction. Negative life experiences~     may also affect the risk of addiction. Researchers want to test smokers and nonsmokers to~     study genetic and brain function traits that may lead to drug addiction.~      Objectives:~      - To understand brain function in people who may be at a higher risk of drug addiction.~      Eligibility:~        -  Healthy volunteers between 18 and 55 years of age.~        -  Smokers (10 to 30 cigarettes per day for more than 2 years) and nonsmokers will be~          eligible.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will be~          tested for drug and alcohol use. A blood sample will be collected.~        -  The study will involve one visit. Participants will have a magnetic resonance imaging~          (MRI) scan.~        -  At the visit, participants will answer questions about their health and drug use habits.~          They will then be trained on the tasks they will do during the MRI scan. After the~          training, they will have the scan and perform the tasks. The scan and tasks will look at~          brain function related to rewards and impulsiveness.~        -  Other computer tests will be given after the scan. These tests will measure learning,~          memory, and impulsiveness....~   "
148584|NCT01621594|"~     Title: Evaluating New Radiation Techniques for Cardiovascular Imaging~      Background:~      - Imaging studies such as computed tomography (CT) scans involve the use of radiation to~     create the pictures. Heart and blood vessel CT scans can cause high radiation exposure.~     Different methods of creating CT pictures have been developed to reduce the radiation dose.~     Researchers want to see how effective these new methods are in producing accurate CT scans.~      Objectives:~      - To study new ways of taking pictures of the heart or blood vessels using computed~     tomography.~      Eligibility:~      - Adults at least 18 years of age who will be having imaging studies to help detect heart or~     blood vessel problems.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be taken to check kidney function.~        -  Participants will have a CT scan of the heart and blood vessels. A contrast agent may be~          used to improve the quality of the images. The scanning session may last up to 2 hours.~        -  Participants will have follow-up contact 90 days after the scan, and then yearly contact~          for the next 5 years.~   "
148585|NCT01621581|"~     Background:~      - Glial cell line-derived neurotrophic factor (GDNF) is a chemical that may help protect and~     strengthen brain cells that produce dopamine. Dopamine is a chemical that affects brain~     function. People with Parkinson's disease (PD) have problems producing dopamine in the brain.~     Researchers want to see if gene transfer can help deliver GDNF into the area of the brain~     that is damaged by PD. The gene transferred in this study, called AAV2-GDNF, may help produce~     GDNF to protect the damaged brain cells.~      Objectives:~      - To test the safety and effectiveness of AAV2-GDNF gene transfer for advanced PD.~      Eligibility:~      - Individuals at least 18 years of age who have advanced PD that is not well controlled by~     medications.~      Design:~        -  Participants will be in the study for about 5 years. There will be 18 outpatient study~          visits and a 3-day stay in the hospital. There may also be overnight stays for followup~          visits.~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Tests of PD symptoms and mood and memory will be given. Imaging~          studies will be used to find the right part of the brain to infuse the gene. The~          screening visit will take place up to 60 days before surgery.~        -  Participants will have a baseline visit about a month before the surgery. For 1 week~          before the baseline visit, participants will keep a diary on any motor problems. The~          visit will involve movement tests given before and after taking a regular dose of~          levodopa.~        -  Participants will have surgery to infuse AAV2-GDNF into the brain. The surgery will also~          include a lumbar puncture (spinal tap) to collect cerebrospinal fluid. After surgery,~          participants will recover in the hospital for at least 2 days.~        -  Participants will have another lumbar puncture 6 and 18 months after surgery. This will~          be an outpatient visit.~        -  Participants will have regular followup visits after the surgery. These visits will~          include neurological tests and movement studies. Visits with a neurosurgeon will take~          place 1, 2, and 4 weeks after surgery. Additional visits will take place every 3 months~          for the first 3 years, and then at longer intervals for up to 5 years.~   "
148586|NCT01621568|"~     Background:~      - Sunitinib is drug that is approved for treating various types of cancers, including kidney~     cancers. However, it has not been approved to treat cancers of the thymus. Sunitinib works by~     blocking proteins that are responsible for cell division and growth. Some of these proteins~     can be found on thymus cancer cells. Researchers want to see if sunitinib can be used to~     treat advanced thymus cancer. It will be given to people who have had at least one earlier~     chemotherapy treatment containing platinum.~      Objectives:~      - To see if sunitinib is a safe and effective treatment for advanced thymus cancer that has~     not responded to earlier treatments.~      Eligibility:~        -  Individuals at least 18 years of age who have advanced thymus cancer that has not~          responded to earlier treatments.~        -  At least one previous cancer treatment must have been chemotherapy treatment containing~          platinum.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and tumor biopsies will be used to check the~          severity of the cancer.~        -  Participants will take sunitinib tablets once a day, in the morning. They will take the~          tablets daily for 4 weeks, followed by 2 weeks of rest with no sunitinib. This 6-week~          period is called a cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Treatment cycles may be repeated as long as the tumor does not continue to grow and~          there are no severe side effects....~   "
148587|NCT01621555|"~     The purpose of this study is to investigate whether there is a correlation between a patients~     pain sensitivity and their subsequent post-operative pain and surgical outcome in~     arthroscopic shoulder surgery.~   "
148588|NCT01621542|"~     This clinical study is designed to evaluate the safety, immunogenicity and antitumor activity~     of WT2725. WT2725 will be administered to patients with advanced malignancies known to~     overexpress WT1~   "
148589|NCT01621529|"~     Use of positron emission tomography (PET) in determination of functional tumour volume can~     provide usable information for radiotherapy to define the irradiated volume.~      To determine the best tumour volume measure method, the investigators have chosen as model~     the breast cancer which allows us to study a stationary or moving organ by the patient~     position and belonging to a primary surgery.~      The used methodology is based on lesion volume measure in preoperative time, obtained with~     PET, and on the measure of specimen volume by the anatomic laboratory after surgery.~      This study's main objective is to compare this two measure of tumour size and secondarily to~     compare TEP with or without respiratory gating.~      The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3~     times:~      A whole body acquisition in supine position, follow by a centered tumour acquisition with~     respiratory gating, then an acquisition in prone position to immobilise the lesion.~      This study is monocentric and descriptive. It provides to include 30 patients in 1 year.~   "
148593|NCT01621477|"~     The primary aim of this protocol is to evaluate if the one-year survival is significantly~     improved in the group of patients who receive a T-cell replete haploidentical donor~     hematopoietic cell transplant (HCT) with a novel reduced intensity conditioning regimen.~     Study population will consist of patients (21 years or under) with hematologic malignancies~     that have relapsed or are refractory after prior allogeneic transplant. Toxicity will be~     evaluated by the rate of transplant related mortality and the rates of moderate and severe~     graft-versus-host disease (GvHD) at day 100. The investigators will describe event-free, and~     disease-free survival at one year, as well as the rates of hematopoietic recovery and donor~     engraftment and study comprehensively immune reconstitution following T-cell replete~     haploidentical transplantation.~   "
148594|NCT01621464|"~     Physiological stimulation therapy effectiveness will be proved with contractility sensor or~     CLS sensor (Closed Loop Stimulation), in BIOTRONIK CLS pacemakers to prevent from~     neuromediated syncope. Furthermore, not only will be investigated if this system eradicates~     syncopes, but also if the number of presyncopal episodes is reduced.~   "
148595|NCT01621451|"~     Aspirin and/or clopidogrel users are increasing due to increased prevalence of cardiovascular~     or cerebrovascular disease with an aging society in Korea. Also, the patients having~     endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for early~     gastric cancer or gastric premalignant lesions including adenoma and dysplasia are increasing~     among aspirin and/or clopidogrel users. Practically, aspirin or clopidogrel is recommended to~     be stopped for 5~14 days before EMR or ESD because bleeding risk during or after procedure.~     And it is recommended to restart of aspirin and/or clopidogrel as soon as possible if~     immediate bleeding during or after the procedure is not occurred in consideration of~     thromboembolic risk. However, early restarting of aspirin and/or clopidogrel raise the risk~     of delayed bleeding and the risk of complications associated with delayed ulcer healing.~     Although it is important to determine the timing of restarting aspirin and/or clopidogrel in~     consideration of complications of post-EMR/ESD ulcer and thromboembolic risk, there is no~     definite guideline about the timing of restarting aspirin and/or clopidogrel.~      This study is aimed to determine the timing of restarting aspirin and/or clopidogrel for the~     patients having EMR or ESD among aspirin and/or clopidogrel users. The investigators planned~     to compare the delayed bleeding rate and ulcer healing rate in patients with post-EMR/ESD~     ulcer when take proton pump inhibitor (pantoprazole 40 mg per day) between the patients~     restarting aspirin and/or clopidogrel within 3~4 days after the procedure and the patients~     restarting aspirin and/or clopidogrel 2 weeks after the procedure during 4 weeks. The primary~     endpoint is delayed ulcer bleeding rate at 4 weeks after EMR/ESD. The secondary end point is~     ulcer healing rate within 4 weeks.~   "
148596|NCT01621438|"~     This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel~     fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel~     disease. For this purpose, the clinical data of the patients with 3-vessel intermediate~     coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical~     needs, will be analyzed.~   "
148597|NCT01621425|"~     Docetaxel is used as a first line anti-cancer drug in the treatment of several cancers,~     mainly breast- and metastatic castration-resistant prostate carcinoma.~      Anti-cancer drugs are being dosed based on patients estimated Body Surface Area in order to~     equalize total drug exposure. Nevertheless, docetaxel treatment is characterized by highly~     interindividual pharmacokinetic variation leading to toxicity and under-treatment.~      The investigators will determine which anthropometric parameters, LBM, total body weight~     (TBW) or BSA correlate best to docetaxel exposure (AUC) for both males and females.~   "
148598|NCT01621412|"~     The investigators believe that disclosure of HIV status could influence medication adherence.~     If disclosure leads to social support, adherence could be improved. This study purpose is to~     assess correlation between disclosure and medication adherence, and to describe people whose~     HIV status has been disclosed to.~   "
148599|NCT01621399|"~     The purpose of this study is to determine if product 55394 is safe and efficacious for the~     treatment of bacterial vaginosis.~   "
148600|NCT01621386|"~     This study will explore the utility of magnetic resonance imaging (MRI) to assess ventilatory~     defects that occur due to asthma, determine the sensitivity and specificity of MRI in~     response to drug treatment, and whether MRI can serve as a biomarker of treatment effects due~     to asthma therapy.~   "
148601|NCT01621373|"~     The aim of the study is to explore the optimal propofol dose in neonates receiving a single~     intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE~     (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective~     non-INSURE procedures (term-preterm neonates).~   "
148602|NCT01621360|"~     The objective of this study is to determine if patients with femoroacetabular impingement~     (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years~     post-operative with respect to physical function, pain, and health related quality of life,~     compared to similar patients who receive conservative management, including medication and~     physiotherapy.~   "
148603|NCT01621347|"~     The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy~     and postpartum, and to record adherence barriers and facilitators.~   "
148604|NCT01621334|"~     This research is a stage 1b developmental trial evaluating an intervention called The Men's~     Domestic Abuse Check-Up with adult men abusing their intimate partners and also struggling~     with alcohol or drug use.~   "
148605|NCT01621321|"~     This is a research project to evaluate the efficacy and safety of two different treatment~     protocols in Allergic bronchopulmonary Aspergillosis.~   "
148617|NCT01621165|"~     Mania has been considered to be, in part, a hyperadrenergic state. One focus of treatment of~     mania involves directly targeting this hyperexcitable state by reducing arousal with~     antiadrenergic agents. This can be achieved by decreasing norepinephrine release by~     stimulating presynaptic inhibitory receptors. Prazosin, FDA approved for the treatment of~     high blood pressure works in part by blocking postsynaptic alpha-adrenergic receptors.~     Prazosin has been found to be clinically useful for the treatment of Post Traumatic Stress~     Disorder. It is reasonable, therefore, to anticipate that prazosin might be helpful in the~     treatment of mania.~   "
150464|NCT01597024|"~     The primary aim of this work is, to 'relate psychological and behavioural parameters of~     hunger/satiety and food preference to gut hormones, neural activation and energy metabolism~     by dietary manipulation, across the human lifespan'.~   "
148606|NCT01621308|"~     Almost all patients with type 1 diabetes mellitus (T1DM) need insulin treatment permanently.~     For selected patients who are unable to achieve glycaemic targets with subcutaneous (SC)~     insulin treatment, continuous intraperitoneal (IP) insulin infusion is an third-line~     alternative.~      Previous studies demonstrate that continuous intraperitoneal insulin infusion (CIPII) using~     an implantable pump device improves glycaemic control and quality of life in patients with~     'brittle' T1DM. Nevertheless, literature comparing IP and SC insulin treatment is scarce.~      The primary objective of this study is to compare the effects of IP insulin delivery to SC~     insulin delivery.The null hypothesis (H0) of the current study holds inferiority of CIPII~     compared to SC insulin regarding long-term glycaemic control. The alternative hypothesis (H1)~     is the inverse: CIPII is non-inferior to SC insulin. In summary, H0: CIPII is inferior to the~     SC insulin treatment H1: CIPII is not inferior to SC insulin treatment~      This is an investigator initiated, open label and prospective matched-control study with a~     non-inferiority design. The trial duration is 36 weeks and is conducted in a single-centre~     (Isala Clinics, Zwolle). If non-inferiority is established superiority analyses are~     performed.~   "
148607|NCT01621295|"~     Communication is an important component of comprehensive cancer care impacting patient~     satisfaction, adherence, and quality of life. The wide array of issues addressed in cancer~     clinical interactions makes communicating about a broad range of topics (including quality of~     life, communication, symptom control, complementary/alternative therapies, costs, treatment~     burden, prognosis, anxiety, side-effects, sexual function, palliative care options, etc.)~     especially interesting and potentially challenging. Some of these topics may not be routinely~     addressed in the clinical interaction or may require consultative support from other members~     of the comprehensive cancer care team. One frequently overlooked critical element in research~     on communication between cancer clinicians, their patients, and their primary care clinicians~     is describing real-time consultations between patients and their clinicians. These~     interactions provide rich material for assessing key psycho-social dynamics and identifying~     issues that patients find important in their care. In order to devise systems of care that~     optimize the patient experience, it is critical that clinicians and researchers understand,~     appreciate, and systematically characterize the richness and complexity of the~     decision-making process in routine cancer consultations between cancer patients and their~     treating clinicians. This study seeks to assess the patient experience in cancer care by~     observing patients and their physicians in their clinical interactions and following them for~     several months to see how their care went. By describing in-depth the conversations and~     experiences of patients in these clinical interactions, this study will lay the foundation~     for practice-based interventions to optimize patients' interactions with their cancer care~     teams.~   "
148608|NCT01621282|"~     Running successful journal club is of the important goals for postgraduate education.In this~     study, the effect of a 6-month interactive educational course on journal clubs of Mashhad~     Dental school was observed using a valid and reliable checklist(r=0.74). Data will be~     evaluated and compared using spss software by t-test.~   "
148609|NCT01621269|"~     Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12~     months~   "
148610|NCT01621256|"~     The purpose of this study is to determine whether ancrod is effective and safe in the~     treatment of sudden sensorineural hearing loss (SSHL).~   "
148611|NCT01621243|"~     People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and~     gemcitabine in combination with an investigational agent called necuparanib (M402). It is~     made from heparin, which is a well known blood thinner. Blood thinners have been shown in~     prior animal and human studies to have anti-cancer effects. Necuparanib has been~     re-engineered from heparin to have much lower blood thinning activity while keeping the~     anti-tumor activity. The investigators are testing whether necuparanib administered in~     combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel and~     gemcitabine.~   "
148612|NCT01621230|"~     The aim of this study is to measure the effects of bupivacaine administered via epidural~     catheters on indices of motor blockade ascertained during the second stage of labor. This is~     a randomized, double-blind, controlled trial designed to address the primary research~     question: Does bupivacaine lengthen the second stage of labor? The secondary research~     question is: Is there other evidence of motor blockade attributable to bupivacaine during the~     second stage of labor?~      The investigators know from prior studies that the length of the second stage in nulliparous~     women delivered at Parkland Hospital without epidural analgesia is 28 minutes. The~     investigators hypothesize in this now proposed study that epidural analgesia with bupivacaine~     will significantly increase this baseline from 28 minutes to 37 minutes or more (a 33%~     increase) thus implicating motor blockade. Baseline data for the Bromage and Breen scores~     during the second stage as well as the uterine contractility data are not available as these~     indices of motor blockade have not here-to-fore been studied in this context.~      Currently at Parkland Hospital, 82% of nulliparous women undergoing induction of labor at~     term receive continuous epidural infusions with bupivacaine during the first and second~     stages of labor. Such women will be identified when admitted for scheduled inductions at~     Parkland. After informed consent is obtained standard management of labor induction will be~     provided. Those consented women reaching 8 cm cervical dilation will be randomized. Group I~     will receive bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10~     cm dilation) and Group II will receive only fentanyl infusion via epidural catheter (see~     study procedure below). Both the patient and the caregiver will be blinded as to whether the~     patient is in the bupivacaine plus fentanyl arm or the fentanyl only arm. To detect a 33%~     increase (from 28 minutes to 37 minutes) in the primary outcome the investigators need a~     total of 310 women enrolled in the study (or 155 per arm). Assuming a 30% consent rate and~     given that approximately 1000 women meet the inclusion criteria each year at Parkland, the~     investigators project that this study could be completed in 12 months.~   "
148613|NCT01621217|"~     -  To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and~          mitomycin C when given together with the antibody cetuximab in patients with locally~          advanced cancer in the anal region~        -  To evaluate acute toxicity~        -  To evaluate late toxicity~        -  To evaluate response rate~        -  To evaluate recurrence free survival~        -  To evaluate overall survival~   "
148614|NCT01621204|"~     This is a study to investigate if eltrombopag can be used instead of Intravenous Immune~     Globulin (IVIG) in patients with ITP, to adequately raise their platelet count when they~     undergo minor or major surgery. Eltrombopag is a daily, oral pill approved for treatment of~     ITP. IVIG is a blood product frequently used to treat ITP. Patients with ITP who need surgery~     have to get treatment to increase their platelet count. IVIG is commonly used for this~     purpose but eltrombopag may be more effective and convenient for patients.~   "
148615|NCT01621191|"~     The purpose of the study is to assess the safety and efficacy of duloxetine in participants~     with fibromyalgia at long-term use.~   "
148616|NCT01621178|"~     The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide~     compared to insulin glargine in the treatment of participants with type 2 diabetes and~     moderate or severe chronic kidney disease.~   "
148618|NCT01621152|"~     Introduction: Acute kidney injury (AKI) increases mortality, hospital cost, and rate of~     progression toward end stage kidney disease 1-4. Early diagnosis and management of AKI is~     known to improve the above mentioned outcomes.~      Hypothesis: the investigators will design and validate an electronic surveillance tool to~     screen all the ICU admissions for the earlier, more efficient diagnosis of AKI and as a~     result improve the outcome of AKI in ICU patients.~      Methods: the investigators plan to use the patient database, and AKIN (AKI network)~     definition to design an electronic alert system to allow clinicians discover patients who~     develop AKI. Then a randomized clinical trial will be conducted to compare earlier~     intervention (based on Kidney Disease: Improving Global Outcomes [KDIGO] guidelines)~     initiated by AKI sniffer alert to the conventional management provided by primary physician~     in ICU.~   "
148619|NCT01621139|"~     The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the~     requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite~     recovery process, and 4) improve the quality of life.~   "
148620|NCT01621126|"~     In a study performed by the Harvard Shoulder Service, it has been documented that there is a~     significant incidence of neurologic complications of the Latarjet procedure for shoulder~     instability. 5 out of 52 patients had neurologic complaints post-operatively. 3 of these~     nerve palsies were transient, however 2 had not yet recovered fully at time of latest~     follow-up and returned to the operating room for exploration and neurolysis of the axillary~     nerve and brachial plexus.~      By using intra-operative neuromonitoring to determine exactly when there is a potential nerve~     injury during the procedure, the investigators will be able to modify what the investigators~     do at that step of the procedure, in order to decrease or possibly even eliminate the risk of~     neurologic injury.~   "
148621|NCT01621113|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of treatment~     with dalfampridine in combination with locomotor training in persons with chronic, motor~     incomplete SCI.~   "
148622|NCT01621100|"~     The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily~     OROS (Osmotic Release Oral System [a controlled release oral medication delivery system in~     the form of a tablet]) hydromorphone for cancer pain treatment in Korean cancer patients.~   "
148623|NCT01621087|"~     The substitution of polyunsaturated fatty acids (PUFA) for saturated fatty acids (SFA) is a~     cornerstone of worldwide dietary advice for coronary heart disease (CHD) risk reduction.~     However, clinical CHD benefits specific to the omega-6 PUFA linoleic acid (LA), and distinct~     from omega-3 PUFAs, have not been established. The Sydney Diet-Heart Study (SDHS; 1966-1973)~     was a randomized controlled secondary CHD prevention trial testing whether selectively~     increasing omega-6 LA from safflower oil in place of SFA reduced CHD and improved survival. A~     full analysis of mortality outcomes has not been published. The investigators recovered the~     original SDHS dataset, which included detailed longitudinal dietary, smoking and coded~     mortality data, permitting evaluation of smoking relapse rates, and all-cause, CVD and CHD~     mortality outcomes by nutrient intake and duration of diet exposure. Data recovery also~     permitted the first complete meta-analysis of LA intervention trials on mortality outcomes.~      Objectives are (1) to evaluate whether increasing dietary linoleic acid alters CVD and CHD~     mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed~     mortality differences.~   "
148624|NCT01621074|"~     During endurance exercise in the heavy and severe intensity domains, the rate at which~     metabolites that have been associated with the fatigue process (e.g. Pi, ADP, H, and~     extracellular K) accumulate increases. possibly leading to exercise cessation. Sodium~     bicarbonate, as a nutritional supplement, has gained attention over the past decades, because~     it might delay of offset fatigue. To date, there is a controversial discussion about which~     delivery mode (amount and frequency) might be best in optimizing endurance performance. Since~     the high ion load consequent to multiple ingestions might increase plasma volume, and~     consequently decrease bicarbonate concentrations, single acute ingestion could be more~     beneficial. However, in multi-day competitions or tournaments it might be necessary to use~     the supplement on a daily basis. Here, the investigators aim at investigating the effects of~     single dose or multiple dose (on five consecutive days) administration of bicarbonate vs.~     placebo increases endurance performance and acid-base homeostasis in trained male endurance~     athletes.~   "
148625|NCT01621061|"~     High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term~     residents at altitudes >2500 m, is characterized by dyspnea, hypoxemia, impaired exercise~     performance and hypertension in the pulmonary circulation. Whether sleep related breathing~     disturbances, common causes of nocturnal hypoxemia in lowlanders, are also prevalent in~     highlanders and promote pulmonary hypertension in highlanders is unknown. Therefore, the~     current study will investigate whether highlanders with high altitude pulmonary hypertension~     have a greater prevalence of sleep apnea than healthy highlanders and lowlanders.~   "
148626|NCT01621048|"~     Radiotherapy plays an important role in the curative treatment of head and neck cancer. This~     treatment however is associated with significant acute and late toxicity with xerostomia and~     dysphagia severely implicating the patient's quality of life. With highly conformal~     radiotherapy techniques it is possible to decrease de dose to the organs at risk while~     maintaining adequate doses to the tumour. In order to adequately register the effect of these~     techniques it is imperative to obtain standardized information on the acute and late~     treatment effects. With this study the investigators want to evaluate this toxicity using~     standardized and validated questionnaires during follow-up. This data will then be correlated~     to the doses delivered to the specific organs at risk.~   "
148627|NCT01621035|"~     The purpose of the present study is to evaluate the validity of 2 objective measures of~     physical activity among older adults. In addition, the investigators will examine the~     influence of functionality, walking aids, walking speed and step length on the accuracy.~   "
148628|NCT01621022|"~     Focus of this study was to determine if bupropion was more effective for smoking cessation~     when used alone or combined with nicotine gum.~   "
148629|NCT01621009|"~     The purpose of this study was to determine if bupropion plus counseling was more effective~     than bupropion alone or counseling alone in helping smokers quit smoking.~   "
148639|NCT01620866|"~     The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR),~     an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning,~     quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.~   "
148630|NCT01620996|"~     Study Purpose and Design~      The goal of this study is to improve CVD risk in a primary care adult population, with the~     following primary objectives~        1. To improve management of global cardiovascular risk of patients within two primary care~          practices, thereby improving their overall cardiac health.~        2. To increase patient compliance with lifestyle aimed at pharmaceutical interventions~          aimed at decreasing global cardiovascular risk.~      Secondary objectives of the study are:~        1. To examine the utility of a process to improve the management of global cardiovascular~          risk of patients within two primary care practices.~        2. To explore the utility of a process that links primary care practices with existing~          community resources in order to manage cardiac risk factors better among individuals~          within those primary care practices.~        3. To determine the economic impact of a global risk assessment and management process~          within a primary care setting.~   "
148631|NCT01620983|"~     Patients undergoing knee replacement surgery and who have high levels of pain catastrophizing~     are at risk for poor outcome. The clinical trial is designed to determine if a pain coping~     skills training intervention delivered by physical therapists and supervised by psychologists~     is more effective at reducing pain and improving function and is more cost effective than~     arthritis education or usual care.~   "
148632|NCT01620970|"~     Salvage chemotherapy for advanced urothelial cancer (UC) yields suboptimal response rates of~     15-40%, a median progression-free survival of 2-4 months and a median overall survival of 6~     months. A rationale for targeting angiogenesis in UC is supported by preclinical evidences~     and early signals of clinical activity of anti-VEGF TKI as demonstrated by our group with the~     use of pazopanib.~      Despite this activity, progression inevitably occurs and mechanisms determining resistance to~     conventional anti-angiogenic agents are under investigation.~      PF-03446962 (Pfizer Inc) is a novel fully human monoclonal antibody (mAb) against ALK1 with~     dose-dependent antiangiogenic activity as demonstrated in nonclinical studies in a chimera~     mouse model bearing human tumor xenograft. The investigators suggest that PF-03446962 may~     increase current results for patients with advanced urothelial cancer failing upfront~     chemotherapy due to its mechanisms of action. Due to the lack of reliable and reproducible~     predictors of response as well as of imaging tools to assess tumor response, the trial will~     provide incorporation of 18FDG-PET/CT and contrast-enhanced ultrasound to stage and evaluate~     response of urothelial cancers, together with standard imaging modalities (RECIST criteria).~     Blood and tissue samples will be collected for translational purposes.~   "
148633|NCT01620957|"~     Several studies in healthy volunteers have suggested that the synchronized functional~     connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and~     when required, a switch in the activity between the DMN and other networks involved in~     specific congnitive functions, would occur. This interaction permit to make the hypothesis,~     that baseline brain activity is likely to shape our ongoing  stream of consciousness  and~     could correlate with conscious perception. The investigators hypothesized that DMN~     connectivity strength would be related to the level of consciousness of brain-damaged~     patients. The investigators will follow severely brain-injured patient in coma. Clinical~     examination using standardized behavioural scales: FOUR score (Full Outline of~     UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI~     (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30~     (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state~     between 30 and 60 days, an additional clinical and brain imaging assessment will be performed~     to identify related changes in brain activity (visit 1*) Monitoring of vital parameters will~     be performed in patients by a senior anaesthesiologist throughout the experiment.~   "
148634|NCT01620944|"~     The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency~     virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48~     of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either one~     additional drug [Lamivudine (3TC) 300 mg daily] or 2 additional drugs~     [Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily].~   "
148635|NCT01620931|"~     This randomized, observer-blinded, placebo-controlled study will assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers.~     Subjects will be randomized in cohorts to receive single ascending intravenous or~     subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4,~     with a safety follow-up of 15 weeks after dosing.~   "
148636|NCT01620918|"~     -  Baseline:~             -  Standard preparation of the osteotomy~             -  Placement of 2 dental implants~             -  On each implant one of both types of healing abutments is placed~             -  Suturing~             -  Standardized radiography to measure bone-levels at baseline~             -  Digital impression of the surrounding gingiva with an intra-oral scanner (a~               non-invasive method) to measure the baseline level of the gingiva~        -  2 weeks after Baseline:~           o Removal of the sutures~        -  4 weeks after Baseline:~             -  A 2nd digital impression of the soft tissue with an intra-oral scanner~             -  Collecting crevicular fluid by placing paperpoints in the provided apertures in the~               healing abutments for 60 seconds without bleeding.~             -  Measuring of the pocket depth in the provided apertures in the healing abutments~               with an automated probe.~             -  Removal of the Healing Abutment with the attached soft tissue en-bloque.~             -  Placement of a new, regular, Encode Healing Abutment.~        -  10 weeks after Baseline:~             -  Start of standard prosthetic procedure. In this study we expect that the soft~               tissue attachment (i.e. the gingival attachment) will be stronger and earlier~               achieved at the nano-structured healing abutments than at the normal, uncoated~               healing abutments. This would lead to a more stable soft tissue complex on the long~               rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger~               attachment would mean a stronger barrier against micro-organisms and might~               influence the occurrence of peri-implantitis.~   "
148637|NCT01620905|"~     Cervical spine manipulation has been shown to be helpful for some patients with neck pain.~     This study sought to determine factors which were predictive of which patients with neck pain~     would benefit from manipulation.~   "
148640|NCT01620853|"~     The purpose of the study is the identification of chromosomal aberrations in non-small cell~     lung cancer (NSCLC) .~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classifying ALK FISH stained lung samples.~   "
148641|NCT01620840|"~     Lacosamide is a new antiepileptic drug (AED) marketed as Vimpat with three different~     formulations, tablets, oral syrup and a solution for intravenous infusion. Lacosamide is~     approved as adjunctive therapy in epilepsy patients with partial onset seizures with or~     without secondary generalization. The i.v. solution is used in patients in which oral~     administration is not possible or adequate. Bioequivalence with oral tablets and safety could~     be demonstrated in healthy volunteers and in patients switched from tablets to Lacosamide~     i.v. solution. A recently published study demonstrates the feasibility of single loading~     doses up to 300 mg. The aim of this Lacosamide i.v. registry is to collect systematically~     data on the safety, tolerability and administration procedures when Lacosmide i.v. is used in~     routine daily clinical practice, mainly in hospitals. These data will help treating~     physicians to optimize the use of Lacosamide i.v. in clinical routine.~   "
148642|NCT01620827|"~     This study is being conducted to evaluate the hypothesis that study subjects will be more~     responsive to follow-up phone calls made from personal cell phone numbers than from hospital~     landline numbers. To evaluate this, study subjects previously enrolled in a cardiac biomarker~     study (the Early Identification of Acute Coronary Syndrome study) were randomized to receive~     their follow-up phone calls (the calls associated with the Early ID study occur at 30 days~     and 1 year after initial enrollment) from either a hospital office landline or from the~     personal cell phones of the research assistants making these calls. This was done as a 1:1~     randomization. The number of call attempts required to reach the study subjects were recorded~     as the calls were made and the date of successful follow-up was recorded once contact was~     made.~   "
148643|NCT01620814|"~     Comparison of intravaginal misoprostol and dinoprostol for the purpose of cervical ripening~     before diagnostic hysteroscopy in the women at the reproductive age:RANDOMİSED,CONTROLLED~     PROSPECTİVE TRİAL Objective. Comparison with one another and with control group of vaginal~     dinoprostol and misoprostol with for the purpose of cervical ripening before diagnostic~     hysteroscopy.~      Population: It was planned for performing to 95 women who appealed to gynecology polyclinic~     and will be performed diagnostic hysteroscopy.~      Methods: Eighty-six women who will be performed diagnostic hysteroscopy assigned as randomize~     to three groups. It was planned that none procedure will be applied to group 1 for cervical~     ripening, vaginal misoprostol and vaginal dinoprostone will be practiced to Groups 2 and 3,~     respectively.~   "
148644|NCT01620801|"~     Hemophilia B is a bleeding disease in males due to very low levels of coagulation factor IX~     (FIX) in the blood. The current treatment is intravenous injection of FIX clotting factor~     concentrates, in response to bleeding. This study will focus on the severe, most common type~     of hemophilia B. This study plans to use a virus called adeno-associated virus (AAV), which~     in nature causes no disease, and can be engineered to deliver the human FIX gene (AAV8-hFIX19~     vector) to liver cells, where FIX is normally made. This study will use the AAV8-hFIX19~     vector.~   "
148645|NCT01620788|"~     The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan~     50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.~   "
148646|NCT01620775|"~     This study is designed to assess:~      Hypothesis #1: That there is a significant central pain component in a distinct subset of~     patients diagnosed with knee osteoarthritis(KOA), Chronic low back pain(CLBP), painful~     diabetic neuropathy(PDN.)~      Hypothesis # 2: To establish a reliable strategy for differentiation of central pain~     predominant from peripheral pain predominant knee osteoarthritis(KOA), chronic low back~     pain(CLBP)and peripheral diabetic neuropathy(PDN) patients using clinical features,~     experimental pain testing and magnetic resonance(MR) Spectroscopy.~   "
148647|NCT01620762|"~     The purpose of this study is to compare the treatment effect of two treatment regimens of~     Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue~     medication usage and Quality of Life.~   "
148648|NCT01620749|"~     The purpose of this study is to investigate the safety and potential effectiveness of the~     imaging compound 18F MEL050 for finding sites of melanoma.~   "
148649|NCT01620736|"~     This is a study of the effect of raltegravir on human T-cell leukemia virus type 1 (HTLV-1)~     viral load in asymptomatic patients. The study will enroll 14 subjects for a period of 2~     months of treatment and 1 month of followup. The study will assess the effect of raltegravir~     on virus load in peripheral blood lymphocytes, level of virus gene expression, and sites of~     viral integration.~   "
148650|NCT01620723|"~     The purpose of this study is to evaluate if the developed theory and evidence based programme~     has a positive effect on mother's breastfeeding self efficacy, establishing an effective~     breastfeeding and breastfeeding duration after short time hospitalization.~   "
148651|NCT01620710|"~     This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with~     higher daily doses and shorter total treatment time compared to standard fractionation) of~     the prostate bed with or without the pelvic lymph nodes.~   "
148652|NCT01620697|"~     While perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value~     as independent parameter in predicting postoperative complications after colorectal resection~     remains poorly investigated.~      The investigators want to test the value of perirenal fat as surrogate of visceral obesity as~     risk factor for morbidity in colorectal surgery and to compare it to the effect of Body mass~     index (BMI) and Waist- Hip ratio (WHR).~   "
148689|NCT01620216|"~     This phase II trial studies how well targeted therapy works in treating patients with acute~     lymphoblastic leukemia or acute myelogenous leukemia that has come back after a period of~     improvement or does not respond to treatment. Testing patients' blood or bone marrow to find~     out if their type of cancer may be sensitive to a specific drug may help doctors choose more~     effective treatments. Dasatinib, nilotinib, sunitinib malate, sorafenib tosylate, and~     ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving targeted therapy based on cancer type may be an effective~     treatment for acute lymphoblastic leukemia or acute myelogenous leukemia.~   "
148899|NCT01617486|"~     This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for~     Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT)~     and designed to reduce overweight in postpartum teens. The intervention will focus on the~     replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and~     sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion~     size, and walking).~   "
148653|NCT01620684|"~     This project will examine whether short-term (over a 12-hour period) pharmacological lowering~     of the stress hormone 'cortisol' improves the nervous system response to food intake in~     overweight or obese individuals who have metabolic syndrome.~      The investigators know from our previous research that overweight/obese persons who are~     insulin resistant, have a blunted sympathetic nervous response to carbohydrate ingestion.~     This means that they are less able to dissipate energy from caloric intake, which would~     favour the maintenance of the obese state. Cortisol adversely impacts on insulin action and~     transport into the brain and cortisol levels are often elevated in persons with central~     (abdominal) obesity.~      A randomized, double-blind, placebo controlled, cross-over design will be used to compare the~     effects of overnight treatment with metyrapone (15 mg/kg at midnight and 15 mg/kg at 6 am)~     versus placebo on sympathetic nervous system activity in response to a standard 75-g oral~     sugar (glucose) tolerance test. A 2 week washout will separate treatments.~      Metyrapone is a drug that reversibly inhibits the enzyme 11beta-hydroxylase, and therefore~     the production of cortisol. It is used clinically to test the activity of the adrenal gland~     (the key site of cortisol production) and the pituitary gland. The investigators anticipate~     that at the dosage used, it will lower blood cortisol concentration by 44 to 64% during the~     experimental morning.~      The study protocol comprises two screening visits and two experimental mornings. Key~     procedures will include:~        -  Assessment of insulin action (sensitivity) using the gold standard 'clamp' method.~        -  Measurement of sympathetic nervous system activity by both biochemical methods (isotope~          dilution which provides a measure of the apparent rate of release of 'noradrenaline'-the~          key neurotransmitter in the sympathetic nervous system) and direct intra-neuronal nerve~          recordings from the peroneal nerve in the lower leg.~        -  Indirect calorimetry to assess resting metabolic rate and the response to sugar~          ingestion.~        -  DEXA scan to quantify fat and lean mass.~        -  Assessment of arterial elasticity and calf blood flow by non-invasive methods.~        -  A standard 75g oral sugar tolerance test.~      The results will provide important new information regarding the role of cortisol on nervous~     system function in overweight/obese individuals.~   "
148654|NCT01620671|"~     The concept of enhanced recovery after surgery has become increasingly popular in elective~     abdominal surgeries. Yet, the role of this concept has not been described in emergency~     procedures. Therefore, this study aimed to investigate the feasibility of fast-track surgery~     in patients with perforated peptic ulcer.~   "
148655|NCT01620658|"~     The primary objective of the present trial is to compare the radiation attenuation provided~     by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection~     (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days~     of fluoroscopy guided cardiology interventions. The second objective is to compare the~     operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared~     to the standard fabric caps.~   "
148656|NCT01620645|"~     The UK Medical Research Council (MRC) together with the Association of British Pharmaceutical~     Industries (ABPI) have recently funded a program designed to foster collaboration between~     academic COPD researchers and the pharmaceutical industry in the UK, with the aim of~     developing and furthering our research capacity and expertise for the benefit of patients~     living with this prevalent and disabling condition. This builds on the strong international~     track record of COPD research in the UK. The program is divided into four work packages~     (WP1-4), each with specific aims. WP1 will collate and establish data from patient cohorts~     and share this information through the development of knowledge management platforms. WP2~     will specifically assess how airway micro-organisms impact on COPD and how the effects of~     bacteria and viruses may be modified. WP3 is concerned with tissue injury and repair which~     are fundamental processes in the development of COPD. WP4 will examine in detail the~     potential for improving patient outcomes by targeting the skeletal muscle dysfunction that~     can profoundly affect exercise capacity.~   "
148657|NCT01620632|"~     The purpose of this research study is to collect data on the technical aspects of~     Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients~     with Roux-en-Y gastric bypass surgery.~   "
148658|NCT01620619|"~     The null hypothesis is that there is no statistical difference between the two treatment~     groups for any outcome. The investigators suspect that patients who undergo a Bankart lesion~     repair with rotator interval closure will have lower quality of life and less external~     rotation compared to patients who undergo a Bankart lesion repair alone. No difference will~     be observed for recurrence rate between the two treatment groups~   "
148659|NCT01620606|"~     Functional abdominal pain (FAP) is a common complaint of childhood, associated with~     considerable health care costs, disruption of normal activity, emotional distress, and~     long-term health effects. The study will test a treatment approach which, if successful,~     would substantially change the treatment for FAP and potentially for a wide range of~     childhood medical problems where parental responses to symptoms contribute to these adverse~     effects. The study would also provide a model which would be much more accessible than~     traditional face-to-face therapies to a broader range of families in need than are currently~     served.~   "
148660|NCT01620593|"~     Prostate cancer is the most common non-cutaneous cancer in men. Patients with recurrent or~     metastatic prostate cancer are treated with androgen-deprivation therapy, often termed~     castration therapy. While the short and medium term benefits of castration are clear in~     relation to therapeutic efficacy in patients with prostate cancer, it is now appreciated that~     the resulting hypogonadism associated with castration is responsible for adverse consequences~     or metabolic syndrome that include increase in body mass index (BMI) and fat mass,~     hyperinsulinemia and insulin resistance, hyperlipidemia, reduced lean body mass (LBM) and~     muscle strength, osteoporosis, sexual dysfunction, poor quality of life and higher~     cardiovascular mortality. Lower testosterone levels in men independently predict the~     development of metabolic syndrome. Low testosterone levels in men are associated with insulin~     resistance and diabetes. Metformin is commonly prescribed for the treatment of type II~     diabetes because it lowers both glucose and insulin levels. Studies show preliminary evidence~     that metformin might have both antineoplastic and chemopreventative activity. Castration~     therapy decreases insulin sensitivity, adversely alters lipid profiles and results in weight~     gain, and it may be associated with a greater incidence of diabetes and cardiovascular~     disease. Little is known about the optimal strategy to mitigate the adverse metabolic effects~     of castration in men with prostate cancer. The rationale for using metformin in castrated men~     with advanced prostate cancer stems from the observation that castration therapy is~     associated with the metabolic syndrome, hyperinsulinemia and insulin resistance. Furthermore,~     reports that hyperinsulinemia stimulates insulin receptor expression on prostate cancer~     leading to tumor growth and development of castrate resistant prostate cancer suggest~     metformin through its activation of the AMPK-LKBI pathway reduces liver gluconeogenesis~     secondarily decreasing insulin levels may circumvent tumor growth and resistance to~     castration therapy. More importantly, evidence that metformin inhibits the mTOR pathway~     implicates an added therapeutic benefit as an anti-cancer agent.~   "
148661|NCT01620580|"~     Self-management intervention may decrease symptom burden and improve functioning over time.~   "
148690|NCT01620203|"~     Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can~     have considerable effects on neurodevelopmental outcome.~      The investigators showed that preterm infants with severe ICH have decreased cerebral~     oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of~     decreased cerebral oxygenation in preterm infants and the effects on cerebral function are~     unknown.~      This longitudinal observation study will evaluate physiologic parameters to determine trends~     in cerebral oxygenation and function in preterm infants with ICH in comparison to infants~     without ICH.~   "
159608|NCT01476969|"~     The purpose of this study is to determine whether Remote Ischemic Perconditioning is~     effective on Acute kidney injury in adult valve replacement.~   "
148662|NCT01620567|"~     Cognitive impairment is also a major risk factor for development of dementia later in life.~     Findings from the investigators studies suggest that the carotenoids, lutein and zeaxanthin~     may be important in cognitive function in the elderly. Avocados are a source of these~     carotenoids. The investigators study evaluates long-term avocado intervention as a treatment~     strategy for age-related cognitive impairment which could possibly prevent the onset of~     dementia. The investigators have also shown that lutein supplementation significantly~     improved verbal fluency scores in healthy older women. Based on these findings, the next~     logical step will be to investigate the ability of lutein and zeaxanthin contained in~     avocados to influence cognitive function in older adults. The investigators hypothesize that~     there will be a significant increase in cognitive function measures in older adults provided~     with meals containing 1 avocado/day at the end of 6 months, while no significant improvements~     will be observed in older adults given daily meals containing chickpeas and/or potatoes.~      The proposed study is designed as a randomized, placebo controlled trial that tests the~     effects of 6 month supplementation with 1 avocado/day on cognitive function in older adults.~     Secondary analyses will determine whether baseline macular pigment (lutein in retina which~     canbe measured non invasivley) density predicts relative effectiveness of the intervention on~     cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and~     inflammation.~   "
148663|NCT01620554|"~     Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5~     parallel groups (dose-range).~   "
148664|NCT01620541|"~     End-stage ankle arthritis (ESAA) is a debilitating condition associated with severe pain,~     dysfunction, and reduced quality of life. Many patients with ESAA have difficulty walking for~     even 100 feet or up a single flight of stairs. Patients seeking surgery for ESAA have two~     primary treatment options: ankle arthrodesis (i.e., ankle fusion) and ankle arthroplasty~     (i.e., ankle replacement). Few studies have directly compared the effectiveness of these two~     procedures, and no randomized controlled trials (RCTs) have been performed.~      The investigators will compare the following in subjects undergoing ankle arthrodesis and~     ankle arthroplasty before surgery, and post-surgery at 3 and 6 months, and on an annual basis~     up to ten years.~        1. Overall physical function and ankle specific function~        2. Ankle pain intensity and interference with activities~        3. Activity levels~        4. Overall general health~        5. Post-surgical complication rates~      The investigators will also identify prognostic factors that are predictive of higher~     physical function, ankle specific function, reduced pain, improved general health, and~     overall patient satisfaction.~   "
148665|NCT01620528|"~     A randomized study evaluating the safety and efficacy of elagolix in the management of~     moderate to severe endometriosis-associated pain in adult premenopausal female subjects.~   "
148666|NCT01620515|"~     This study is designed to evaluate the safety and efficacy of a single injection of NX-1207~     for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients~     currently undergoing active surveillance. Study participants currently on active surveillance~     will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5~     mg or 15 mg) followed by active surveillance or to no treatment (continued active~     surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate~     biopsy.~   "
148667|NCT01620502|"~     The first part is a double-blind placebo-controlled trial to identify the effects of omega-3~     polyunsaturated fatty acids (PUFAs) in prevention of IFN-induced depression. The second part~     is a double-blind trial to identify the antidepressant effects of omega-3 PUFAs in patients~     with IFN-induced depression.~   "
148668|NCT01620489|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to investigate the efficacy and safety of liraglutide in subjects with type 2~     diabetes and moderate renal impairment.~      The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin~     regimen.~   "
148669|NCT01620476|"~     This trial is conducted in Japan. The aim of this trial is to assess the safety and~     tolerability of liraglutide in healthy Japanese male subjects.~   "
148670|NCT01620463|"~     This trial is conducted in Japan. The aim of this trial is to assess the safety and~     tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.~   "
148671|NCT01620450|"~     This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced~     by current process and the NN2000 process in healthy Japanese subjects.~   "
148672|NCT01620437|"~     This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence~     of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.~   "
148673|NCT01620424|"~     This trial is conducted in Japan. The aim of this trial is to investigate the~     pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and~     biphasic insulin aspart 50 (NN-X14Mix5050) in subjects with type 2 diabetes.~   "
148674|NCT01620411|"~     This study aims to investigate the relative effectiveness of two different pain management~     plans for injuries sustained while active duty in the military. One arm of the study has~     subjects undergo standard comprehensive medical management, while the other adds the~     placement of a spinal cord stimulator, a common procedure for the alleviation of pain.~   "
148691|NCT01620190|"~     This research study examines the use of Abraxane (paclitaxel albumin-stabilized nanoparticle~     formulation) in patients with lung cancer. Abraxane is a chemotherapy approved to treat~     patients with breast cancer. Doctors want to know if Abraxane is safe and effective in~     treating patients with lung cancer that has spread to other places in the body and usually~     cannot be cured or controlled with treatment (advanced) and epidermal growth factor receptor~     (EGFR) mutations.~   "
148692|NCT01620177|"~     The purpose of this study is to expand understanding of the effects of cannabis on driving~     performance with and without the presence of low levels of alcohol.~      This project will involve the development a of a protocol and driving environment that is~     sensitive to the effects of cannabis on driving performance by building on prior driving~     situations used previously for testing the effects of alcohol on driving.~   "
149034|NCT01615718|"~     In this study, the investigators aim to investigate the effects of non-invasive~     neurostimulation - low-intensity transcranial electrical stimulation in conjunction with~     transcranial ultrasound (TUS)- on the motor symptoms associated with Parkinson's disease. The~     investigators want to see if there is a difference between active and sham stimulation on~     these motor symptoms.~   "
148675|NCT01620398|"~     There are no studies exploring the benefits of a diet composed of typical Brazilian food in~     the secondary prevention of cardiovascular diseases. Randomized studies show that the~     Mediterranean diet is beneficial for patients with established cardiovascular disease or in~     risk for CVD development. Indeed, nutritional composition of the Mediterranean Diet is one of~     main references for dietary guidelines for treatment and prevention of CVD in Brazil and the~     world. However, in many countries, such as Brazil, most foods of the Mediterranean diet are~     not widely available, may be expensive or are not part of population eating habits. So, the~     prescription of the Mediterranean diet intervention for cardiovascular disease to the~     Brazilian population may not be feasible, leading to a low adherence. In this context,~     patients with established CVD have a low compliance to nutritional prescription. The BALANCE~     Program, considers 3 concepts: a) A dietary prescription guided by nutritional content~     recommendations from the Brazilian national guidelines; b) A nutritional education program~     based on fun, playful strategies and suggestions of affordable foods; and c) Intensive~     follow-up through one-on-one visits, group sessions, and phone calls. This is the first~     proposal to use these concepts concurrently with the objective to increase adherence of~     secondary prevention patients to the diet proposed by the guidelines. Therefore, The primary~     outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction,~     stroke, myocardial revascularization, amputation for peripheral arterial disease, or~     hospitalization for unstable angina.~   "
148676|NCT01620385|"~     The primary purpose of the research is to study how individuals who wear cochlear implants~     process sounds in noisy environments and also whether newly designed programs can help~     improve the communicative ability of cochlear implant patients in noisy situations.~   "
148677|NCT01620372|"~     The FCCSS is a multicentric national large-scale collaborative population-based study of~     children treated for a solid tumor before 2000 in France and before the age of 19 years.~      The study is concerned by improving knowledge about the long-term effects caused by cancer~     and its treatments including adverse health and social outcomes.~      The main reason of the FCCSS is to estimate the risk of adverse health and social outcomes~     that may occur after a cancer treatment and to prevent them by providing adapted follow-up~     care.~      The cohort will be followed for up to 20 years from 2011.~   "
148678|NCT01620359|"~     The goal of this prospective, non-randomized, single-arm, multi site, international study is~     to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the~     ablation of breast cancer and of MRI.~      The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume in~     a treatable and device accessible location.~   "
148679|NCT01620346|"~     The objective of this study was to evaluate the advanced maternal age as a rationale for~     performing intracytoplasmic morphologically selected sperm injection (IMSI).~      This prospective randomized study included couples undergoing intracytoplasmic sperm~     injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly~     allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33).~     The groups were compared with regard to fertilization rate, percentage of high-quality~     embryos, implantation, pregnancy and miscarriage rates.~   "
148680|NCT01620333|"~     This trial is conducted in Japan. The aim of this trial is to investigate the~     pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70~     (NN-X14Mix70) in Japanese healthy volunteers.~   "
148681|NCT01620320|"~     Left main stenosis use to be treated by bypass but with the improvement of angioplasty~     techniques, an increasing number of patients are submit to left main coronary angioplasty.~     Consequences of left main intra stent stenosis can be disastrous yet, for the moment, no~     precise recommendation concerning the follow up of these patients exist. The investigators~     ought to determine if stress echocardiography can predict left main intra stent stenosis as~     well (non inferiorly)as control angiography that use to be done.~   "
148682|NCT01620307|"~     Severe H1N1 pneumonia with acute respiratory failure shows hyperactive immune cells~     infiltration of lung. Rapamune, a mTOR inhibitor, modulates the immune response by blocking~     activation of T- and B-cells. To investigate the clinical efficiency of rapamune in severe~     H1N1 pneumonia with respiratory failure, this study was conducted.~   "
148683|NCT01620294|"~     After open colorectal surgery the surgical site infection (SSI) is very high among abdominal~     surgeries. The goal of the investigators randomized, prospective, multicentric,~     internet-based study is to compare rate of SSI after surgery of colon and rectum by using~     triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are~     involved in this study. Two arms are separated by computer randomization at abdominal wall~     closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus).~     Triclosan is an antiseptic material which the investigators hope will provide better local~     infection control at the site with reducing the risk of bacterial colonisation.~   "
148684|NCT01620281|"~     This pilot study is designed to evaluate the efficacy of the no!no!Back continuous passive~     motion device in relieving of mild to moderate non-specific low back pain.~   "
148685|NCT01620268|"~     This study will evaluate the clinical efficacy and safety of a combination of leflunomide and~     orotic acid in kidney transplant patients with high levels of Polyoma BK viruria for the~     purpose of preventing Polyoma BK viremia and Nephropathy that could lead to kidney transplant~     loss from viral damage, acute rejection or both.~   "
148686|NCT01620255|"~     To determine the dose or doses of PF-00547659 that will be the most effective to improve or~     halt the disease symptoms in patients with moderate to severe ulcerative colitis.~   "
148687|NCT01620242|"~     This is a multi-center phase II study assessing whether cabazitaxel could be efficient for~     treatment of recurrent or metastatic head and neck cancer after failure of cisplatin,~     cetuximab and taxanes.~   "
148688|NCT01620229|"~     This phase I/II trial studies the side effects and best way to give brentuximab vedotin and~     to see how well it works after donor stem cell transplant in treating patients with~     hematologic malignancies. Monoclonal antibodies, such as brentuximab vedotin, can block~     cancer growth in different ways. Some block the ability of cancer to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them. Monoclonal~     antibodies may kill cancer cells that are left after donor stem cell transplant.~   "
152565|NCT01569386|"~     Low intensity physical activity by half squat of the elderly people with hemiplegia~     significantly slow down the pulse wave velocity of the arteries of the lower limbs of the~     paralyzed side within 8 weeks.~   "
148693|NCT01620164|"~     Parkinson's disease is characterized by motor deficits, improved by dopaminergic intakes.~     Besides motor symptoms, visual troubles are observed in patients with Parkinson's disease, in~     particular spatial orientation problems including 3D vision. However, although these visual~     disturbances are commonly reported by the patients and their family in our clinical~     experience, they have not been the subject of specific clinical studies yet.~      Parkinsonian patients report deficits in 3D vision leading to a loss of visuomotor ability,~     locomotor functions and to falls. Despite these frequent complaints, little is known about 3D~     vision in Parkinson's disease. The investigators want in this project to precisely estimate~     3D deficits in parkinsonian patients by assessing their psychophysical performances in 3D~     vision tasks to compare to age matched control subjects' performances.~   "
148694|NCT01620151|"~     Primary: To compare the post-operative pain in patients with neck extension and without neck~     extension.~      Secondary: To determine the benefit of neck exposure and peri-operative complications, which~     include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and~     hypocalcaemia in both groups.~      Hypothesis: Patients who undergoing thyroidectomy without neck extension will have less~     post-operative pain and there are no significant difference of post-operation complications~     between both groups.~   "
148695|NCT01620138|"~     There are no available medical treatment options for patients with non-functioning pituitary~     adenomas (NFPA) or with resistant prolactinomas to dopamine agonists (DA) who are not cured~     by surgery. The study of the receptors by quantitative messenger ribonucleic acid (mRNA)~     expression levels and immunohistochemistry analysis might end with a better understanding of~     these tumors. Besides that, it will be assessed the in vitro and in vivo responses to~     pasireotide (for NFPA and prolactinomas) and cabergoline (for NFPA). These responses will be~     compared with the receptor expressions which may be a tool as a predicting element of the~     response to these compounds.~   "
148696|NCT01620125|"~     Recent data suggest that the trillions of bacteria in the investigators gastrointestinal~     tracts (gut microbiota) can function as an environmental factor that modulates the amount of~     body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant~     to developing diet-induced obesity and have lower fasting insulin and glucose and improved~     glucose tolerance. Administration of the probiotic bacterium Lactobacillus strain in~     fermented milk for 12 weeks reduced adiposity and body weight in obese adults, possibly by~     reducing lipid absorption and inflammatory status. However, there are no studies to the~     investigators knowledge that address whether probiotic supplementation improves glucose~     metabolism in type 2 diabetes patients.~   "
148697|NCT01620112|"~     The purpose of this study is to determine whether different clonidine concentration on~     axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the~     sensory and motor block onset time and duration, postoperative analgesia duration,~     postoperative pain intensity~   "
148698|NCT01620099|"~     Asthma is an inflammatory disease affecting the whole respiratory system, from central to~     peripheral airways. Anti-inflammatory treatment with inhaled corticosteroids (ICS), with or~     without long-acting β2-adrenoceptor agonists (LABA), is the cornerstone of asthma management~     [GINA Guideline - available at www.ginasthma.com]. Nevertheless, a considerable subset of~     asthmatic patients neither benefits from ICS nor gain optimal asthma control even with~     ICS/LABA combinations.~      The involvement of the distal lung, i.e. the peripheral membranous bronchioles < 2 mm in~     diameter (so-called small airways), in the pathogenesis of asthma has been extensively~     investigated and its significance debated. However, whether specifically targeting distal~     lung abnormalities can lead to further clinical benefit is still an open question. In this~     context, interest has been raised by hydrofluoroalkane (HFA) pressurised metered-dose~     inhalers, which can deliver compounds with a mass median aerodynamic diameter that is~     significantly smaller than other available devices, leading to increase peripheral airways~     drug deposition.~      Up to 30% of asthmatic patients smoke, mirroring the rate found in the general population.~     Several data document that smoking habit negatively affect corticosteroid efficacy in asthma.~     In particular, asthmatic patients who smoke experience faster lung function decline,~     increased frequency of exacerbations and reduced asthma control despite being regularly~     treated. Several molecular mechanisms have been proposed to address the issue of reduced~     corticosteroids responsiveness in smoker patients. However it has been never investigated~     whether reduced corticosteroid responsiveness in asthmatic patients who smoke can be related~     to more severe small airways involvement leading to impaired distribution or impaired~     peripheral deposition of inhaled corticosteroids. If this is the case, asthmatic patients who~     smoke might benefit from a pharmacological approach able to target and to reach small~     airways.~   "
148699|NCT01620086|"~     This study compares the efficacy of low and high frequency repetitive transcranial magnetic~     stimulation (rTMS) as a means of treating subjects with schizophrenia. Magnetic pulses~     delivered over the scalp cause brain activity. This activity has been shown to help decrease~     the intensity and frequency of auditory hallucinations (AH) in schizophrenia. The~     investigators will compare whether low or high frequencies work best. The investigators will~     also examine what changes occur in the brain that are related to improvement.~   "
148700|NCT01620073|"~     The investigators hypothesize that home based HIV counseling and testing can increase male~     partner uptake of HIV testing during pregnancy.~      The investigators study aims through a randomized clinical trial to determine whether a~     home-based model (HBM) versus a partner-friendly clinic model (PFM) can increase male uptake~     of HIV counseling and testing during pregnancy.~   "
148701|NCT01620060|"~     This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose~     study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum,~     autistic spectrum disorder, or other psychiatric disorders.~   "
148702|NCT01620047|"~     Major surgery involving the knee is often associated with severe postoperative pain.~     Postoperative pain control remains a significant contributor to delayed recovery and length~     of hospital stay. Approaches to minimize postoperative pain after surgery are a matter of~     major concern due to the need for early mobilization, a crucial factor in good postoperative~     rehabilitation. Femoral nerve blocks by either continuous infusion or single injection of~     anesthetics provide an effective method for analgesia while minimizing the need for systemic~     opioid therapy, reducing the opioid induced side effects, and facilitating early ambulation.~     Administration of fentanyl has shown to be a highly effective method to control pain after~     Total Knee Replacement (TKR). The investigators hypothesize that fentanyl infusions will~     result in greater post-operative strength in the operative knee.~   "
148765|NCT01619228|"~     The skin barrier lipids will be lower in premature infants than in full term infants and will~     become normal over 3-4 months after birth. The higher skin pH in premature infants will be~     related to an altered lipid composition which will change as the skin acidifies.~   "
152566|NCT01569373|"~     Samples of blood and urine will be analyzed for biomarkers to check their predictivity of~     Graft-versus-Host Disease (GVHD) outcomes.~   "
148703|NCT01620034|"~     Stereotactic Body Radiotherapy (SBRT) has emerged as a new treatment option for peripherally~     located lung tumours, offering very high rates of tumour eradication, with minimal side~     effects. Even though this treatment option is being adopted in more and more cancer centres,~     there is still no consensus about the optimal schedule for the radiation treatment. Generally~     speaking, most lung SBRT schedules involve delivering 3-4 days of radiation. At the~     Sunnybrook Odette Cancer Centre, the lung SBRT policy is to deliver 4 days of radiation over~     11 days (each treatment given once very 3rd day). However, some centres deliver the same~     treatment over 4 days in a row (each treatment given once daily over 4 days). There is no~     evidence from the published literature to suggest that there is any difference in side~     effects between delivering the SBRT over 4 days versus 11 days. To confirm this, the~     investigators propose to conduct a comparative (randomized) study to compare these 2~     approaches.~   "
148704|NCT01620021|"~     Hypotheses:~      • A wearable sensor system can be used to accurately monitor three common gait parameters:~     gait speed, stride length, and torso motion.~      Objectives:~      This study will examine the feasibility of using wearable sensors to monitor common gait~     parameters: gait speed, stride length and torso motion. A wearable sensor system of 8~     commercially available inertial measurement units (IMU) will be composed. These sensors will~     work in unison to monitor the gait parameters.~      Technical Objectives~        -  Gather information on commercially available IMUs~        -  Use computer software to monitor and record data from IMUs~        -  Develop an algorithm that can monitor volunteer gait speed, stride length and torso~          motion~        -  Develop a graphical algorithm that compares healthy patient data to potential mild~          traumatic brain injury (mTBI ) candidates~        -  Determine if there is a potential for mTBI determination using the wearable sensors~        -  Accurately validate the wearable sensor system to the gait parameters measured using a~          Vicon motion analysis system~   "
148705|NCT01620008|"~     The purpose of this study is to determine if delaying cord clamping at the birth of term~     infants effects the early brain development (myelin deposition)as determined by quantitative~     MRI at 4 and 10 months and developmental testing at 4, 10 and 24 months. This study will help~     to establish a scientific basis for the timing of cord clamping with reference to brain~     development.~   "
148706|NCT01619995|"~     The goal of this project is to evaluate the applicability of non-invasive optical imaging for~     the measurement of brain function during investigation of the lower urinary tract.~   "
148707|NCT01619982|"~     The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will~     decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk~     population 2) to develop better understanding of vancomycin and cefazolin pharmacokinetics in~     children undergoing cardiopulmonary bypass (CPB) 3) to assess the barriers to vancomycin~     dosing peri-operatively 4) to assess side effects and risks associated with peri-operative~     vancomycin administration. This will allow us to improve patient care by better understanding~     the benefits or the risks of peri-operative vancomycin administration and potentially~     decrease cefazolin-resistant surgical site infections.~      In addition, this study gives us the opportunity to evaluate cefazolin and vancomycin~     pharmacokinetics (pK) on children on CPB.~      The investigators will take blood samples from 20 patients. In 10 patients the investigators~     will do Cefazolin pK analysis and in the other 10 the investigators will do pK Vancomycin~     analysis. For the remainder of 292 patients, only prospective chart review will be done to~     determine the incidence of SSIs.~      This data will be compared with 936 controls who received only Cefazolin pre-operatively as~     prophylaxis for SSI's.~   "
148708|NCT01619969|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate~     the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with~     Confirmed Dengue Fever.~   "
148709|NCT01619956|"~     The osteotome sinus floor elevation (OSFE) technique has been proved to be a predictable~     procedure for successful implant placement in posterior maxillae with limited bone height~     under sinus. OSFE is considered to be minimal invasive and minimal traumatic while having a~     limitation with regard to the residual bone height. According to the consensus conference in~     1996, OSFE technique without bone grafting should be limited to RBH ranging from 7mm to 9mm.~     However, recent studies reported favorable results even with RBH of around 4mm. Moreover,~     there is still controversy regarding the necessity of a grafting material in order to~     maintain the space for new bone formation. Spontaneous bone formation was observed for OSFE~     without grafting by some researches.~      Due to the lack of randomized controlled trial (RCTs), there is still no clear guideline for~     implant therapy in posterior maxillae with limited bone height. Neither is there any evidence~     to recommend or contraindicate the application of grafting materials in combination with~     OSFE.~      The present RCT is aimed to evaluate the clinical success of OSFE with RBH of 2mm to 6 mm and~     to study whether the application of grafting material in combination with OSFE will be more~     favorable. The hypothesis is that the application of simultaneous grafting has no significant~     advantage in terms of clinical success. Spontaneous bone formation can be observed with~     implants placed using OSFE without grafting.~      90 systemically healthy adults consecutively admitted for oral implant therapy will be~     randomly assigned to 3 test groups. Only one implant system will be used to minimize the~     implant-originated influencing factors. Bio-Oss® will be chosen as the bone substitute as it~     is currently the typical xenograft available. Autogenous bone will be also used as it is~     deemed as 'gold standard' for bone graft materials.~      A panoramic radiograph and an intra-oral radiograph should be taken to assess the~     pretreatment bone height under sinus. For T1 group, the autogenous bone chips harvested~     during the drilling procedure will be mixed up with Bio-Oss®. And the mixture is placed into~     the 'socket' by osteotomes when elevating the sinus membrane until the final depth. For T2~     group, only Bio-Oss® will be placed into the 'socket' by osteotomes when elevating the sinus~     membrane until the final depth. No grafting materials will be used for T3 group. The subjects~     will be recalled for follow-up visits at 3 months, 6 months, 1 year, 2 years and 3 years~     after surgery for clinical and radiographic examination. Implant protrusion length,~     endo-sinus bone gain and crestal bone level will be measured on the radiographs using~     specialized software. ANOVA will be performed for the success rates of the 3 groups.~     Descriptive statistics will be used for the radiographic parameters.~      The present study is aimed to provide preliminary evidence for an important clinical question~     that whether OSFE is predictable and reliable with RBH of less than 6mm and whether the~     application of grafting materials is necessary for this indication.~   "
148710|NCT01619943|"~     The New Orleans Criteria (NOC) and the Canadian CT Head Rules (CCHR) have been developed to~     decrease the number of normal computed tomography (CT) in mild head injury (MHI). The aim is~     to compare the clinical performance of these 2 decision rules for indentifying patients with~     intracranial traumatic lesions and those who required an emergent neurosurgical intervention~     following MHI.~   "
148711|NCT01619930|"~     The purpose of this study is to compare an internet-based behavioral activation program with~     a physical activation program, as treatments for mild to moderate depression. The added~     effect of rationale and motivational interviewing will also be studied, as well as the~     effects of relapse prevention program.~   "
148789|NCT01618916|"~     This is a phase 1 study in otherwise healthy participants with high LDL cholesterol.~     Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body~     handles the drug, and the drug's effect on the body will be evaluated. Participants will~     participate in the study for approximately 3 months not including screening. Screening is~     required within 42 days prior to the start of the study.~   "
148712|NCT01619917|"~     While the literature tends to support the use of laser therapy in the management of burn~     scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser~     therapy can be quite expensive when compared to other treatment modalities for burn scars,~     and while promising, its true usefulness has yet to be conclusively demonstrated. For this~     reason, our assessing the effects of fractional vascular lasers on burn scars. It has been~     hypothesized that the fractional vascular lasers work on mature scars to decrease scar~     formation, and the fractional laser works on scar that is quiescent to promote remodelling.~     The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the~     mesh pattern created by meshed split thickness skin graft).~      Objective:~      To determine the benefit of fractional vascular laser treatment in improving burn scar~     height, texture, vascularity and pliability in late burn scars.~   "
148713|NCT01619904|"~     A Pancreas Transplant is the accepted treatment in patients with Insulin Dependent Diabetes~     Mellitus (IDDM) and end-organ failure. Simultaneous Pancreas and Kidney (SPK) Transplant is~     done in over 90% of cases. At present there is a 5- 8% 30-day mortality with over 80% graft~     survival at 1 year. At Manchester Royal Infirmary (MRI) approximately 40 cases are done per~     year.~      Goal-Directed Therapy (GDT) involves fluid resuscitation intra-operatively and early in the~     post-operative period, guided by cardiac output monitoring. The mechanism of therapeutic~     benefit is thought to be related to improved tissue oxygenation and oxygen delivery. There~     are a number of studies showing significantly improved biochemical markers of inflammation in~     animal models and in studies on septic patients (patients with an overwhelming infection)~     following GDT. Studies have also shown that GDT improves clinical outcome in post-operative~     patients and in serum inflammatory mediators. These studies have looked at major abdominal~     surgery but none have investigated transplant patients. Given the nature of surgery we feel~     that our patients would benefit with reduced Intensive Care Unit stay, reduced length of~     hospital stays and reduced rates of post-operative complications.~      The study will be conducted on all adult patients undergoing pancreas transplant at MRI. It~     will last for 2 years and we hope to recruit 60 patients~      Patients will be randomised into Standard Therapy (ST) or GDT groups, with ST being current~     practice. Each intervention will last for six hours post-operatively before continuing with~     normal care thereafter. Omental fat biopsies will be taken from patients intra-operatively~     and blood samples will be taken from patients at regular intervals for 72 hours intra- and~     post- operatively. Patients will be followed up daily while an in-patient and at~     three-monthly intervals in out-patients for 1 year.~   "
148714|NCT01619891|"~     Despite recent advances and even when receiving optimal therapy, patients with chronic heart~     failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent~     symptoms. The investigators have shown that patients attending the Leeds Integrated Heart~     Failure Service are also frequently deficient in vitamin D and that the severity of the~     deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and~     response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle~     contractile function, immune function, pancreatic insulin release, and neuro-hormonal~     homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has~     demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a~     randomised, placebo-controlled developmental clinical study in 250 patients with CHF and~     vitamin D deficiency. The present study is designed to detect whether vitamin D has~     pathophysiologically important effects, as well as providing preliminary evidence of efficacy~     and safety by examining cardiac function (using cardiac magnetic resonance imaging) and~     submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data to~     inform a larger multi-centre efficacy and effectiveness study.~   "
148715|NCT01619878|"~     The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data~     following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body~     weight (BW) with uncomplicated falciparum malaria.~   "
148716|NCT01619865|"~     This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging,~     and measurement of response to treatment in patients with somatostatin receptor positive~     tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care~     which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high~     resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in~     diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those~     patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as~     anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used~     to measure response to treatment. These studies will be obtained with the long term goal of~     submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and~     children.~   "
148717|NCT01619852|"~     The study seeks to investigate a safe and inexpensive strategy to reduce persistent~     post-surgical pain that can affect up to 60% of patients undergoing surgical procedures. It~     also seeks to investigate specific brain changes associated with the development of chronic~     pain. This may lead to the development of more specific and more effective treatments.~      Hypotheses:~        1. Perioperative systemic lidocaine reduces the incidence of chronic pain in patients~          undergoing surgical procedures.~        2. There is a specific brain morphological/function change associated with the development~          of chronic pain.~   "
148718|NCT01619839|"~     NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe~     chronic pain - active as a mu agonist, but with inherent molecular properties designed to~     provide a unique clinical profile, including most notably, reduced CNS side effects and an~     attenuated attractiveness as a target of abuse.~   "
148719|NCT01619826|"~     The objective of this study is to use a randomized controlled design to determine whether~     cardiorespiratory fitness training improves neurocognitive function and academic performance~     during preadolescent development.~   "
148720|NCT01619813|"~     The purpose of this study is to find out if giving Reolysin in combination with docetaxel and~     prednisone can offer better results than standard therapy with docetaxel and prednisone.~   "
148721|NCT01619800|"~     The goal of this trial is to test the effect/benefit of a FDA approved blended pacemaker~     sensor which responds only by comparing physical activity, heart rate, and breathing rate;~     compared to the accelerometer pacemaker sensor which respond only by comparing physical~     activity and the heart rate in patients whose heart is unable increase its heart rate~     according to increase physical activity or demand (Chronotropic Incompetence). Only one~     pacemaker family will be used in this clinical trial whereas the out of box configuration~     is the blended sensor which can also be made to act only as an accelerometer.~   "
148722|NCT01619787|"~     The goal of the proposed study is to apply experimental economics in an online grocery store~     shopping model to examine the effects of pricing on hypothetical food purchases~   "
148723|NCT01619774|"~     The goal of this clinical research study is to learn if the combination of 2 drugs dabrafenib~     and trametinib can help to control melanoma that has or has not spread to the brain. The~     safety of this drug combination will also be studied.~      Dabrafenib is designed to block the mutated BRAF protein. This mutation is only found in~     moles of the skin and in melanoma cells. By blocking the protein, the drug may slow the~     growth of or kill cancer cells that have the protein.~      Trametinib is designed to block certain proteins that cause cancer cells to grow and~     multiply. This may cause the cancer cells to die.~   "
148724|NCT01619761|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if giving cells called natural killer~     (NK) cells after receiving a chemotherapy treatment and a UCB transplant can improve response~     in patients with leukemia, lymphoma, or MM. The safety of this treatment and whether NK cells~     can lessen the risk of graft vs. host disease (GVHD) will also be studied.~      Patients with a disease that is CD20-positive will also receive rituximab on this study.~      The first 3 patients enrolled on this study will not receive NK cells but will receive a cord~     blood transplant.~      UCB and NK cells may be able to kill leukemia, lymphoma, or myeloma cells that remain in your~     body after chemotherapy treatment.~      The UCB cells are also designed to increase blood production and strengthen your immune~     system.~      This is an investigational study. Cyclophosphamide, fludarabine, melphalan, lenalidomide, and~     the UCB transplant procedure are all FDA approved and commercially available for the~     treatment of CLL. Cyclophosphamide is approved for the treatment of CLL. Fludarabine is~     approved for treatment of refractory CLL. Melphalan is approved for the treatment of multiple~     myeloma (MM) but has been used in transplant conditioning regimens. Lenalidomide is approved~     for the treatment of low risk myelodysplastic syndromes and for MM. Rituximab is approved for~     the treatment of CD20 positive B-cell lymphomas and chronic lymphocytic leukemia (in~     combination with chemotherapy).~      The use of NK cells in patients is investigational.~      Up to 13 participants will be enrolled in this study. All will be enrolled at MD Anderson.~   "
148725|NCT01619748|"~     Peripheral vascular function is impaired in people with obstructive sleep apnoea who are~     untreated compared with age-, weight- and sex-matched healthy controls.~   "
148726|NCT01619735|"~     The purpose of this study is to evaluate outcomes of an established procedure for treatment~     of kidney stones that are present within the inner aspect of the kidney. This procedure is~     called flexible ureteroscopy, which involves placing a small camera through the urethra while~     anesthetized (asleep), up the ureter (the tube connecting kidney and bladder) and into the~     kidney to the kidney stone. Then, the stone is broken into tiny fragments using a small laser~     called a Holmium laser. While this treatment is a well-established option for treatment of~     these stones, there are several different techniques used to help eliminate them from the~     kidney. Some urologists treat the stone by a method called active extraction whereby the~     ureteroscope is passed back and forth into the kidney to remove all visible stone fragments.~     Others use a method called dusting whereby the stones are broken into tiny fragments or~     dust with the intention that achieving such a small stone size will allow the stones to~     pass spontaneously. There has not been a systematic and rigorous comparison of these~     techniques in terms of treatment outcomes. By collecting information on the success of~     treatment, the investigators hope to provide benchmark data for future studies of kidney~     stone treatment and improve the care of all patients who need surgery for their kidney~     stones.~      The investigators hypothesize that the stone free rate for renal stone(s) 5-15 mm is around~     90% and that the stone clearance rate with be 20% higher in those patients that undergo~     complete stone fragment extraction versus those that undergo stone dusting (residual~     fragments < 2mm).~   "
148727|NCT01619722|"~     Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease~     (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in~     France, because it is treatable by a diet low in phenylalanine. This plan is required upon~     confirmation of diagnosis and continued until the age of 8 years. The current trend is to~     continue the scheme at least until adolescence. Unlike other countries, in France there are~     no recommendations for a plan for life. Knowledge about the natural history of PKU in~     adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic~     factors are poorly documented. On the other hand, there is no consensus on the therapeutic~     management of this disease in adulthood and monitoring that could be directed towards the~     detection of neurological disorders and nutrition. Social integration and quality of life of~     adults PKU patients living in France have not been studied.~   "
148728|NCT01619709|"~     To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic~     intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We~     hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid~     Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage~     (probably related to hypertension).~   "
148729|NCT01619696|"~     The objective of the present project is to validate the feasibility of a multimodal~     radiological pathway while on chemoradiotherapy, in order to validate potentially predictive~     factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.~   "
148730|NCT01619683|"~     To determine the effects of 12 months of treatment with Androxal on bone mineral density in~     men with secondary hypogonadism.~   "
148731|NCT01619670|"~     Epidermolysis Bullosa (EB) is a very rare disease, with a severe impact on the life of the~     patient and the caregiver. Epidermolysis Bullosa (EB) comprises a group of genetically~     determined skin fragility disorders characterized by blistering of the skin and mucosae~     following mild mechanical trauma. There is no specific proven treatment for any form of EB,~     and the mainstay of clinical management is based on protection and avoidance of provoking~     factors. Chronic nonhealing erosions and ulcers have been treated with conventional~     split-thickness skin grafts. Alternatively some patients may benefit from the use of~     autologous or allogeneic cultured keratinocyte grafts.~   "
148732|NCT01619657|"~     The purpose of this study is to assess whether 6% hypertonic saline (HS) is a safe and~     effective preventive therapy in newborns and infants with cystic fibrosis (CF).~   "
148790|NCT01618903|"~     The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg~     intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy~     volunteers.~   "
148733|NCT01619644|"~     An exploratory phase 2 therapeutic trial in children from 6 to 21, RTS carriers, randomized~     to be treated either with sodium valproate with the usual pediatric dosage (30 mg/kg/j), or~     by placebo for one year.~      The investigator would like to include children because they could best profit from it due to~     their neuronal plasticity as CBP and EP300 take effect through neuronal and synaptic~     plasticity.~      The therapeutic effect of sodium valproate in RTS patients will be assessed thanks to a~     clinical approach (learning and memory neuropsychological evaluation, fine motor skills~     assessment by pointing), to a biological approach (histone acetylation functional tests), and~     to imaging (morphological and functional MRI).~   "
148734|NCT01619631|"~     The purpose of this study is to conduct a pilot randomized controlled trial (RCT) that~     provides the feasibility, safety, and preliminary efficacy data required to design a large~     scale trial evaluating Tai Chi for Chinese Americans with major depressive disorder (MDD) who~     are not on antidepressant medications.~   "
148735|NCT01619618|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This laboratory study is looking at biomarkers in samples from patients with~     recurrent or metastatic head and neck cancer treated on ECOG-E1302 trial.~   "
148736|NCT01619605|"~     The purpose of this study was to investigate the utility of serum tryptase for the~     confirmation of shrimp-induced anaphylaxis.~   "
148737|NCT01619592|"~     Inclusion criteria: adult diabetes patients on multiple daily insulin injections or using an~     insulin pump; Internet users Exclusion criteria: having a severe mental illness Patients will~     be recruited during the conventional consult. If they want to participate, they will get~     detailed information regarding the study; after giving consent; they will sign the informed~     consent form and they will get a unique study number.~      The patient will than complete a questionnaire on a secured website (https://) using the~     unique study number. After completing this questionnaire, the patient will be randomised~     either into a group 'standard care + direct start with web-based diabetes education'~     (intervention group) or they will enter into the other group (control) receiving standard~     care. Three months after the start of the study, all patients will be asked to complete the~     questionnaire again and the patients into the control group will also get access to 'standard~     care + web-based diabetes education'. The questionnaire will have to be completed on months~     6, year 1 and year 2. At the time of completing the questionnaire, HbA1c will be determined.~     This is part of the routine examination in each participating hospital (UZGent and AZ~     Nikolaas). The determination of HbA1c is not study-specific but the value will be taken into~     the study.~      The web-based questionnaire:~      Patients will enter on a website including general study-information. They also have to~     explicitly click a button to proceed to the questionnaire. After clicking on 'I am prepared~     to participate in the study' they will see a second webpage retrieving some general~     information. After receiving this real basic information; they will be redirected to a secure~     website (https://) and will make use of a unique study number. Only the main researcher will~     have the possibility to link the general information to the unique study number.~      The informed consent form:~      The patient will be asked for added information. He/she will have to sign specific pages~     giving explicitly informed consent for information retrieved from the 'mutualiteit' (National~     Health Service - NHS).~      On the NHS information will be asked regarding the health costs. These figures should make it~     possible to have a more objective figure of the costs associated to diabetes (care).~      The patient can stop on every moment the study participation. Once decided he/she wants to~     stop, he/she will receive standard care.~      Study hypotheses: the QoL will improve by the use of web-based diabetes education; there will~     be a reduction in costs using web-based diabetes education; there will be at least an~     equal-stay or improvement of the HbA1c while using web-based diabetes education.~   "
148738|NCT01619579|"~     Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved~     Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and~     psychological assessment. This non-invasive device is able to rapidly raise the core body~     temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating~     element. The change in body temperature may change the sympathetic nervous system's activity~     and thereby reduce Fibromyalgia pain.~   "
148739|NCT01619566|"~     Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber~     characteristics. This can be used to predict which future patients will respond to~     Duloxetine.~   "
148740|NCT01619553|"~     Keloids have a strong genetic component. The goal of this study is to identify genes and~     regulatory elements on chromosomes that are the cause for keloids or contribute to keloid~     scarring.~   "
148741|NCT01619540|"~     Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive~     pulmonary disease (AECOPD).~      This association is frequently underestimated with regard to the difficulty of clinical~     diagnosis .~      The investigators expect that Valsalva Maneuver (VM) could be useful in this issue.~   "
148742|NCT01619527|"~     The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence~     of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg~     tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under~     fed and fasted conditions) in healthy participants.~   "
148743|NCT01619514|"~     The purpose of this study is to evaluate the use of advanced quantitative mass spectometry~     (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor and to~     compare the protein profile between different subtypes of breast cancer (ER positive, HER2~     positive, triple negative). A maximum of 100 breast tumor specimens will be obtained from the~     NUHS Tissue repository, comprising approximately equal proportion of ER positive, HER2~     positive, and triple negative tumors. Samples will be analyzed using advanced Mass~     Spectrometry (Super SILAC) as a discovery platform to identify novel protein biomarkers that~     may be important in cancer. DNA and RNA will also be extracted from tumor samples for~     correlative analysis with the proteomics data. Genomics and proteomics data will be~     correlated with clinical data including treatment response and survival data. Importance of~     proposed research to science or medicine:Identification of tumor biomarkers may allow better~     prognostication, follow-up, and selection of treatment for cancer patients in the future.~     Potential benefits and risks: No direct benefit to the patient. Risk to the subjects is~     minimal as there is no direct patient contact, and analysis is done on previously donated~     tumor samples. Patients have previously provided consent to donate their samples for research~     into the NUHS Tissue Repository.~      Novel tumor biomarkers that determine tumor biology, including prognosis and treatment~     sensitivity, may be detectable using the novel advanced quantitative mass spectromy method~     (Super SILAC). Different subtypes of breast cancers will have different proteomic profiles~     analyzed using super SILAC.~   "
148900|NCT01617473|"~     The use of peripheral blood stem cells(PBSCs) is rapidly growing in the allogeneic~     transplantation setting as an alternative to bone marrow (BM).It was found that the use of~     PBSCs is associated with faster hematologic recovery but have yielded differing results~     regarding the incidence of graft-versus-host-disease (GVHD) and relapse.~      The study hypothesis:~      transplantation of mobilized PBSC to haploidentical donor with standard-risk leukemia had~     comparable engraftment and non-relapse mortality to mobilized BM combined with PBSCs~   "
161580|NCT01451073|"~     The purpose of the study is to evaluate the ability of injections Ji Gami(TM) to induce hair~     growth in male and female subjects with hair loss.~   "
148744|NCT01619501|"~     The overall goal of this research is to enhance the investigators understanding of the~     pathways involved in lung cancer, and to identify new biomarkers and/or therapeutic targets.~     By comparing gene expression between normal lung tissue and tumors growing in lung-specific~     C/EBPa KO mice, the investigators have identified the Bmi-1 proto-oncogene as being~     abnormally upregulated in C/EBPa-deleted tumors. Subsequently, the investigators have~     validated this observation in human lung cancer, implicating the investigators KO mice are an~     effective discovery tool for lung cancer research. Through similar approaches, the~     investigators have already identified (Sonic Hedgehog, SHH), and plan to identify other~     pathways which are abnormally regulated in C/EBPa-/- tumors. In parallel, the investigators~     will proceed to define the clinical relevance of the SHH pathway and the other~     newly-discovered molecular aberrations, by analyzing their expression and correlate it to~     C/EBPa expression on the samples of patients with NSCLC at NUHS. If the investigators~     preliminary data on Bmi-1 will be confirmed, this proto-oncogene may generate useful~     correlates that could be used in diagnosis and treatment of lung cancer, as well as identify~     new prognostic/predictive markers in lung cancer. Similarly, SHH pathway-components may~     behave as potential biomarkers and therapeutic tools for C/EBPa-related lung cancers.~      This proposal seeks to test the hypothesis that pathways which are dysregulated in lung~     tumors growing in a lung-specific C/EBPa KO model can be utilized as discovery tools to~     identify genes involved in human lung cancer pathogenesis.~   "
148745|NCT01619488|"~     This study is to determine if the Lap-band system is safe and effective for use in morbidly~     obese adolescents.~   "
148746|NCT01619475|"~     The study is being conducted for the following reasons:~        1. To determine the prevalence, course, and predictors of poor Health Related Quality of~          Life (HRQOL) outcomes associated with living donor donation.~        2. To collect data and biosamples prior to, during, and after a living donor liver~          transplant (LDLT) among all donors and recipients for use by other adult-to-adult living~          donor liver transplant studies and future studies.~        3. To study the effects of pressure and flow on the outcomes of LDLT.~        4. To characterize the differences between living donor liver transplant and deceased donor~          liver transplant in terms of recipient post-transplant outcomes including patient and~          graft survival, surgical morbidity, and resource utilization.~        5. To compare the long-term histological outcomes in recipients of LDLT and deceased donor~          liver transplant (DDLT) with recurrent hepatitis C virus (HCV) infection.~        6. To understand the history of pain management and to measure quality of care in pain~          control in living donors following partial hepatectomy.~   "
148747|NCT01619462|"~     The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent~     pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New~     Guinean children, who experience early dense upper respiratory tract colonisation with a~     broad range of pneumococcal serotypes, and to compare antibody titres following a booster~     dose of polysaccharide vaccine at 9 months with those children who received no booster at the~     same age.~   "
148748|NCT01619449|"~     To evaluate the efficacy of continuous renal replacement therapy (CRRT) during orthotopic~     liver transplantation (OLT) in clearing excess solutes and improving acid-base parameters.~     The investigators hypothesize that the use of intra-operative CRRT in OLT recipients is~     associated with increased solute removal and improved acid-base statues when compared to~     controls who do not receive CRRT~   "
148749|NCT01619436|"~     The purpose of this study is the randomized blind research of the assessment of the different~     levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass~     (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during~     cardiac surgery, the investigators would like to know if the glycemia levels in clondine~     group will be lower than placebo group.~   "
148750|NCT01619423|"~     The present trial is designed to determine whether pre-treatment with PledOx lowers the~     frequency and severity of side effects from FOLFOX6 administration in patients with~     metastatic colorectal cancer.~      The efficacy of two different doses of PledOx will be assessed when added to FOLFOX6~     chemotherapy as first line treatment of metastatic colorectal cancer.~   "
148751|NCT01619410|"~     In this pilot study, the objective is to determine the prevalence of asymptomatic carriage of~     S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either~     linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the~     investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of~     ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus~     isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient~     population before and after therapy. Given the results of a recent study on linezolid and~     vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA~     carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous~     abscesses than it is with oral clindamycin.~   "
148752|NCT01619397|"~     This Clinical Investigation is designed to provide tolerance, acceptability and safety data~     of a new condom coating, in its intended use to support future application for CE Mark.~   "
148753|NCT01619384|"~     This proposed study aims to determine whether decreasing stress levels in persons with~     posttraumatic stress disorder (PTSD) can lead to a change in the intestinal microbiota,~     assessed 8 weeks after enrollment.~   "
148754|NCT01619371|"~     The purpose of this study is to analyze the effectiveness of an FDA approved Class II medical~     device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of engorgement.~   "
148791|NCT01618890|"~     Study hypothesis:~      Hepatic venous pressure gradient (HVPG)-directed primary prophylaxis with nonselective~     beta-blocker therapy (NSBB) leads to a reduction in first variceal bleeding episodes and is~     cost-effective in the long term.~      Study design:~      A multi-center randomized controlled study comparing nonselective beta-blocker therapy guided~     by the hemodynamic response as determined by the difference in HVPG before and after starting~     oral NSBB therapy, to standard heart rate-guided NSBB therapy in patients with esophageal~     varices due to liver cirrhosis without a history of esophageal variceal hemorrhage.~      Primary study parameters/outcome of the study:~      First variceal bleeding episodes occurring within the first two years.~      Secondary study parameters/outcome of the study:~        -  Mortality~        -  Occurrence of other cirrhosis-related complications~        -  Occurrence of hepatocellular carcinoma~        -  Costs of treatments~        -  Adverse effects~   "
148755|NCT01619358|"~     Multiple myeloma is an incurable bone marrow cancer characterized by an abnormal expansion of~     plasma cells that secretes monoclonal immunoglobulin. Over the years, the molecular and~     genetic heterogeneity of the disease have been dissected. With the maturation of~     technologies, the time is ripe now to apply genomics to diagnose, classify, risk-stratify and~     prognosticate myeloma in the clinical setting and use this information to guide current~     treatment. The investigators hypothesize that the use of gene expression profiling as a~     single test will be more economical, efficient and accurate compared to the current standard~     panel of tests done at diagnosis. The investigators also hypothesize that the investigator~     can use predictive markers to identify prospectively patients who will respond to Velcade and~     that with more effective trebasedonatment, ability to measure depth of response beyond~     conventional complete response become important since more patients are achieving~     conventionally determined complete response. Using a cohort of patients treated on a standard~     treatment protocol based on Velcade-based induction treatment followed by consolidation and~     maintenance treatment, the investigators will study specifically the feasibility and accuracy~     of gene expression diagnostics, the predictive power of the investigators predefined~     predictive markers and the clinical utility of minimal residual disease measurement in~     myeloma. The results of the investigators study will allow us to improve the diagnosis, and~     prognostication of MM patients~        1. The investigators hypothesized that this will speed up diagnosis, provide comprehensive~          information for the classification and risk stratification of MM patients and can~          completely replace the current FISH assay and may be cheaper.~        2. The investigators hypothesized that TRAF3 deletion or mutation and MYC activation will~          identify patients that will have a significantly better response to Velcade.~        3. Modern treatment induced deeper response. More sensitive method of disease detection~          will allow us to know the fully extent of response to these treatment~   "
148756|NCT01619345|"~     This trial is conducted in Europe. The aim of this trial is to investigate whether the volume~     of water administered with NN9924 affects the anatomical location (stomach or proximal small~     bowel) of tablet erosion.~   "
148757|NCT01619332|"~     This study is a three part study to assess the safety and efficacy of LEZ763 on normal~     healthy volunteers and patients with Type 2 Diabetes.~   "
148758|NCT01619319|"~     Onset of psychotic disorders such as schizophrenia, typically occurs during late adolescence~     or early adulthood often resulting in chronic social and occupational disability. Deficits in~     cognition and functional outcome often precede the onset of full-blown psychosis although to~     a lesser degree than observed in schizophrenia. Recent progress in risk identification~     methodology has enabled reliable detection of persons who appear to be putatively prodromal~     for psychosis, that is, at clinical high risk (CHR) of developing a psychotic disorder. Since~     these CHR individuals already evidence cognitive deficits, which increase around the time of~     conversion, cognition is an excellent treatment target. Furthermore, there is clear evidence,~     in schizophrenia and in CHR samples, that deficits in cognition are related to poor~     functional outcome. Thus, treatments targeting cognition may consequently improve functional~     outcome. The primary aim of the project is to reduce cognitive deterioration and improve~     cognition among youths at CHR using cognitive remediation and to test the effectiveness of a~     new cognitive remediation program, the Brain Fitness program, in improving cognition of CHR~     individuals. A control treatment consisting of video games (VG) will be used. The primary~     hypothesis is that the BF group will have improved cognition at the end of treatment and 12~     months post baseline compared to the VG group. A secondary hypothesis is that improved~     cognition will be associated with improved functioning. This is a longitudinal, single blind,~     placebo controlled pilot trial of cognitive remediation in 36 CHR persons. Participants will~     be randomised to either the BF or VG program, which will be administered over a period of 3~     months. Assessments will occur at baseline, post treatment (3 months) and at 12 months after~     baseline. All subjects will be recruited in year 1 of the project and treatment will be~     completed by 15 months. The 40 hours of training will occur 4 days a week, for an hour each~     day, over a period of 10 -12 weeks.~   "
148759|NCT01619306|"~     Objectives:~      Primary objectives:~      • The investigators aim to conduct a questionnaire survey in a South-East Asian tertiary~     institution, to assess whether breast cancer patients and their physicians would consider the~     use of three different kinds of genetic tests currently available to breast cancer patients:~        -  BRCA1/2 germline testing,~        -  CYP2D6 genotyping and~        -  Oncotype DX® testing.~      Secondary objectives:~      To explore factors which might influence their decisions on genetic testing, including:~        1. Acceptability of the tests and anti-cancer management based on the test results~        2. Reliability and affordability of the test~        3. Ability of the test to influence treatment decisions~        4. Broader implications of the test, e.g., psychosocial, financial impact Study design:~          Cross-sectional study, Survey Questionnaires were developed for 3 categories of~          individuals:~             -  Patients with early stage breast cancer~             -  Healthcare professionals caring for breast cancer patients~             -  Medical students /cancer researchers The questionnaires for patients and medical~               students/cancer researchers are similar. The questionnaires contain a brief section~               on demographic information, interest in and past experience with genetic testing.~               Three hypothetical situations are described to determine if participants will agree~               to BRCA1/2 testing, CYP2D6 genotyping and Oncotype DX® testing, respectively. 18~               categorical 'yes'/ 'no' questions explore reasons for their decisions. Each~               scenario requires a short, hand-written response.~      The questionnaire for healthcare professionals contains a brief section on demographics and~     past experience with genetic testing. Three hypothetical situations are described to~     determine if healthcare professionals will recommend their patients for BRCA1/2 testing,~     CYP2D6 genotyping and Oncotype DX® testing, respectively. 12 categorical questions explore~     the reasons for their decision, and physicians are required to rank these in order of~     importance.~      Distribution of questionnaires:~      Questionnaires will be handed out to agreeable participants on the following occasions:~        1. Patients- National University Health System Cancer Centre Level 3 amp; 4 waiting areas~        2. Medical students - before or after lectures, or at personal contact~        3. Cancer researchers - before or after lectures, or at personal contact~        4. Healthcare professionals - before or after NUHS breast tumour board, or at personal~          contact Due caution will be exercised to ensure that the questionnaire is only handed~          out to subjects who are aged 21 years and above.~      No subject identity will be collected for these questionnaires.~      Rationale and Hypothesis:~      BRCA1/2 germline testing, CYP2D6 genotyping and Oncotype DX® testing have all been approved~     for use in clinical practice, but controversy still exists surrounding their utility, and~     apart from BRCA1/2 mutation testing in high-risk individuals, genetic tests are not routinely~     performed in Singapore. BRCA1/2 germline mutation testing is performed in individuals at high~     risk for hereditary cancer. CYP2D6 genotype testing predicts the benefit of adjuvant~     tamoxifen therapy; poor and intermediate metabolisers of tamoxifen may have a higher risk of~     breast cancer recurrence due to lower efficacy of tamoxifen because of less efficient~     conversion of tamoxifen to endoxifen, the active metabolite of tamoxifen. Oncotype DX®~     testing is a gene-expression profiling test performed on a formalin-fixed paraffin embedded~     tumour specimen, to predict the risk of breast cancer recurrence and guide decisions on~     adjuvant chemotherapy. Understanding the attitudes of patients and medical professionals~     toward these genetic tests may help to guide medical oncologists in their clinical~     recommendations and utilization of these tests in breast cancer patients.~   "
148760|NCT01619293|"~     Abstract:~      The most widely studied neuro-markers in traumatic brain injury (TBI) are S100B and neurone~     specific enolase (NSE). S-100B is localized in astroglia. This marker is used to predict~     neuronal damage caused by traumatic brain injury. The investigators conduct a study to derive~     and validate the measurement of S-100B in serum of patients with different types traumatic~     brain injuries.~   "
148761|NCT01619280|"~     Acute lung injury (ALI) is caused by a wide variety of conditions, but always characterized~     by hypoxia and non-cardiogenic pulmonary edema. Current treatment of ALI is supportive and~     treatment of the underlying cause. New therapies to treat severe ALI have not been shown to~     improve survival, and are limited by financial and logistical resources.~      The investigators propose to investigate the role of inhaled sodium nitroprusside (iSNP) in~     ALI. Sodium nitroprusside (SNP) is a vasodilator. When inhaled, SNP may travel to areas of~     the lung participating in gas exchange, and cause the blood vessels surrounding these areas~     to enlarge. This may result in an increase of blood vessels to these areas of the lung, and~     improve oxygenation. Currently, iSNP has not been studied in the adult population. Therefore,~     this study is intended to find the safety profile of varying doses of iSNP.~   "
148762|NCT01619267|"~     Infections related to implantable pacemakers or cardioverters defibrillators are sometimes~     difficult to be diagnosed. Diificulties in the diagnosis include a low sensitivity of~     standard markers of inflammation such as C-reactive protein or white blood cell count and the~     diagnosis is mainly based on the clinical presentation. The observational DIRT-study~     evaluates if new biomarkers may be more suitable to support a diagnosis of device associated~     infections than the currently available ones.~   "
148763|NCT01619254|"~     Impact exerted by intestinal parasitic infections is much higher in developing countries.~     School-aged children are at higher risk from the burden of disease, because they specially~     have many parasitic infections. The poor health results in deficits in physical and cognitive~     development and educational achievements. Nowadays, there is huge commitment among the global~     community to control intestinal parasitic infections and to improve nutritional status of~     young children in developing countries.~      Large-scale anthelminthic drug administration through vertical control programmes is still~     required for the foreseeable future and is, therefore, recommended by the World Health~     Organization (WHO). However, due to the inevitability of re-infection in endemic areas,~     children need to be treated regularly, and once morbidity control is consolidated, the~     strategy must shift to transmission control emphasising access to clean water and adequate~     sanitation. To lower dependency on 'drug only' approach and to enhance sustainability, from~     the onset of control activities, complementary measures should be implemented, that depend on~     available resources.~      Therefore, the investigators are proposing to undertake a randomised controlled trial to~     assess the impact of simple and easy-to-do hand hygiene intervention packages (hand washing~     with soap and hand finger nail clipping) on intestinal parasitic infection prevalence,~     intensity and re-infection rates and on haemoglobin concentration and anaemia prevalence~     rates among 6-15 years old schoolchildren. Our results will provide solid evidence on if and~     how hand hygiene practice affects infection prevalence and re-infection rates, as well as,~     anaemia prevalence among the highly vulnerable age group.~   "
148764|NCT01619241|"~     The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which~     patients will have poorer progression free survival and overall survival in advanced~     Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more~     aggressive treatment.~   "
148792|NCT01618877|"~     The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg~     intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.~   "
148766|NCT01619215|"~     Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease.~     In the absence of chronic alcohol abuse or other liver diseases, NAFLD incorporates a wide~     spectrum of liver pathologies and is defined by fatty infiltration of the liver (simple~     hepatosteatosis). It can progress to non-alcoholic steatohepatitis (NASH) and later fibrosis,~     cirrhosis, and eventually some patients may develop hepatocellular carcinoma with or without~     cirrhosis. The exact cause of NAFLD is yet to be cleared and it is, therefore, an active area~     for research. The diagnosis of NAFLD is achieved through histological examination of liver~     biopsies (invasive), non-invasive markers using serum biomarkers and imaging techniques are~     still under development. Pathological diagnosis can be then subcategorized based on several~     scoring systems. More widely used are the Brunt Score or NAS (NAFLD activity score) and the~     Kleiner's modified NAS.~      Obesity is highly associated with NAFLD, as the epidemic of obesity has made NAFLD more~     prevalent. In addition insulin resistance has been linked to NAFLD and this is explained by~     the increased influx of free fatty acids (FFAs) into the liver. FFA undergoes either~     β-oxidation or esterification with glycerol to form triglycerides (TGs), resulting in an~     additional source of fat in the liver. Due to the strong association of NAFLD with obesity,~     weight reduction procedures are used for the management of NAFLD. In fact, this has been~     shown to be effective by several studies. However, other studies have reported liver~     deterioration after bariatric intervention. This conflict is what makes the effects of~     bariatric procedures a challenging field for further studies. Consequently in this study we~     are aimed to examine histologic, metabolic and liver function changes induced by the~     different therapeutic bariatric procedures.~   "
148767|NCT01619202|"~     The purpose of this study is to examine differences in driving performance on a simulated~     driving assessment between novice teen drivers who receive the Risk Anticipation-Perception~     Training (RAPT) program and novice teen drivers who do not receive the training program.~   "
148768|NCT01619189|"~     Transplantation of allogeneic or autologous limbal epithelial stem cells cultured on human~     amniotic membrane with no feeders in eyes with total limbal deficiency. Prospective~     non-comparative monocentric study.~   "
148769|NCT01619176|"~     Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.~      The molecular bases of this recommendation are not known, the investigators want to compare~     with the usage of high-throughput molecular technologies the variations occurring in patients~     treated with acupuncture and conventional treatment with the ones treated with conventional~     treatment only. The investigators observe the variations in blood and in the gut microbiome.~   "
148770|NCT01619163|"~     Background: Osteoarthritis (OA), a common disabling condition, is the commonest type of~     arthritis worldwide. Knee OA is the 4th leading cause of disability in women. Pain is the~     leading symptom and is often chronic in nature leading to significant morbidity and decreased~     quality of life. Synovitis is prevalent in knee OA and treatment to relieve this synovitis~     may reduce pain.~      Objectives: A randomized double-blind placebo-controlled trial will be conducted to assess~     whether 6 weeks of daily low dose oral prednisolone will improve pain, mobility and systemic~     low-grade inflammation, in the short term and to determine if it sustained long term at 12~     weeks in older adults with moderate to severe knee OA.~      Methods: 125 community-dwelling older adults aged 65 years and above with primary knee OA~     diagnosed according to the ACR criteria for diagnosis of primary OA of the knee will~     berandomized 1:1. Sixty three will receive 7.5 mg/day of prednisolone and 62 will receive~     placebo together with their usual therapy for 6 weeks. The primary outcome measure will be~     pain reduction. Secondary outcome measures will be reduction in systemic inflammation and~     improvements in physical functioning scores. Alterations in dosage of analgesic/NSAID drugs~     used will be recorded. Safety and tolerability were also assessed. Data will be collected at~     baseline, 6 weeks and at 12 weeks to determine any change in results from those obtained at 6~     weeks. Exclusion criteria will include any inflammatory or serious medical condition.~      Knee OA will be documented by radiographic examination using the Kellgren-Lawrence scale.~     Symptomatic OA will be defined as the need to take NSAIDs daily and LequesneAlgofunctional~     Index (LFI)score > 4. Clinical assessment will be include: Visual Analogue Pain Scale (VAS,~     0-100), self-reported physical function as measured with the Western Ontario and McMaster~     Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores, and six-minute~     walk distance (6MWD). All patients will undergo a physical examination and will be questioned~     about the number of flares, pain and analgesic use. Blood samples will be collected and serum~     levels of IL-1, IL-6, TNF-alpha and hsCRP will be measured in all patients.~   "
148771|NCT01619150|"~     The purpose of this study is to investigate which pain mechanisms that can be affected by~     etoricoxib compared to placebo (inactive medication)in subjects with painful knee~     osteoarthritis af 4 weeks of treatment.~   "
148772|NCT01619137|"~     Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin~     treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study)~   "
148773|NCT01619124|"~     Nowadays approximately 80% of children and adolescents with acute lymphoblastic leukaemia~     (ALL) or lymphoblastic lymphoma (LBL) can be cured and become long-term survivors. Avascular~     osteonecroses (ON) appear as serious side-effect of antileukaemic treatment. Frequently ON~     are first diagnosed at higher and than irreversible stages (ARCO III, IV). At these advanced~     stages curative treatment options are not available. Hence ON are associated with~     considerable morbidity concerning pain and immobility and go along with long-term impairment~     of quality of life. Therefore early diagnosis of ON in the follow-up of children and young~     adults with ALL or LBL is a pressing object.~      Within the prospective multicentric observational OPAL-trial patients at risk (aged 10 years~     or older) treated according to the clinical trials ALL-BFM(Berlin-Frankfurt-Muenster Study~     Group), COALL or NHL (Non Hodgkin Lymphoma)-BFM in Germany should be examined with regard to~     the development of ON. By using a treatment associated, risk orientated assessment and~     examination incidence, symptoms and the clinical course of ON are investigated. The validity~     of MRI screening in the early diagnosis of ON in children and young adults is analysed.~      Systematical investigation of patients under antileukaemic treatment is intended to~     contribute to risk adapted diagnostic strategies and to serve as data base for the subsequent~     evaluation of preventive and interventional approaches for the treatment of ON. Long-term~     objective is the reduction of ON-associated morbidity.~   "
148774|NCT01619111|"~     The HER2 status in breast cancer patients may change during the course of the disease. In 30%~     of initially HER2-negative patients with circulating tumor cells (CTC), HER2-positive CTCs~     can be detected in peripheral blood samples(1). At present, it is unclear if therapy based on~     the HER2 status of CTC offers a clinical benefit for these patients. The DETECT III - trial~     compares lapatinib, as HER2-targeted therapy in combination with standard therapy versus~     standard therapy alone in those patients, with initially HER2-negative metastatic breast~     cancer and HER2-positive circulating tumor cells.~      As one of the first interventional trials based on the assessment of CTC phenotypes, the~     DETECT III - trial aims to evaluate the efficacy of HER2-targeted therapy in patients with~     MBC and HER2-positive CTCs as well as the significance of CTC as an early predictive marker~     for treatment response.~   "
148793|NCT01618864|"~     This study is designed to evaluate the efficacy and safety of the Luxe™ device for use in~     wrinkle and rosacea treatment.~      Up to 60 subjects will treat their periorbital and cheek areas daily for 4 weeks and then~     twice a week for an additional 4 weeks. Evaluations of improvement will be conducted at the~     clinic after enrollment and during the treatment at 1, 2, 4, and 8 weeks after initiation.~   "
148775|NCT01619098|"~     Hospital readmissions are common, costly, and potentially preventable. They are also~     potentially responsive to health system interventions. However, it is uncertain which~     components of care transition interventions are efficacious, for which populations, and at~     what cost. This randomized controlled study is part of a larger project that will evaluate a~     three-tiered quality improvement (QI) intervention intended to reduce hospital readmissions~     within 30 days post-discharge from an urban safety net hospital that serves a racially and~     linguistically diverse population (the randomized controlled study evaluates Tier 3). Few~     studies have evaluated care transition interventions to reduce readmissions among low-income,~     diverse patient populations, and the accumulated evidence on the effects of these~     multi-faceted interventions on readmission rates has been inconclusive. This project will~     take advantage of a unique sequence of three QI innovations to reduce hospital readmissions~     implemented beginning in 2007 in an integrated safety net health care system. The~     discharge-transfer tiers are as follows: 1) Tier 1 includes a comprehensive, individualized~     home care plan (HCP) reviewed by the medical service floor nurse with the patient prior to~     discharge; 2) Tier 2 adds the electronic transmission of the HCP to the patient's primary~     care medical home where, on the business day following discharge, a Registered Nurse makes an~     outreach telephone call to the discharged patient to confirm comprehension of the HCP and to~     address medical questions or needs; 3) Tier 3 further adds a community health worker, the~     Patient Navigator, to participate in bedside discussions to develop rapport and learn about~     patients' home situations, weekly outreach calls to assess patients' needs and to facilitate~     communication between the patient and the primary care team, and reminder calls to patients~     prior to all medical appointments to eliminate barriers to outpatient follow-up. The Aim of~     the study being registered is to evaluate the effects of an ongoing randomized natural~     experiment on readmissions, health care use, adherence to medication instructions, and~     preparedness for discharge. This natural experiment features random assignment to one of two~     QI interventions, Tier 2 or Tier 3, and exclusively targets patients at high risk for~     readmission, those with one or more of the following risk factors for readmission: discharge~     diagnosis of congestive heart failure or COPD; length of stay > 3 days; age > 60; or previous~     hospitalization within the past six months.~      The investigators hypothesize that the Patient Navigator intervention (Tier 3) compared to~     usual care (Tier 2) will increase the rates of 30-day post-discharge PCP visits; reduce~     30-day hospital readmission rates; and reduce the total number of days in hospital in the 180~     days following the index admission for high risk patients. The investigators further expect~     that the PN intervention will improve patient adherence to medication instructions in the HCP~     and reduce the probability of reported problems with post-discharge care.~   "
148776|NCT01619085|"~     The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in~     patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the~     follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and~     1199.34), who wish to continue treatment with BIBF 1120.~   "
148777|NCT01619072|"~     This randomized controlled community-based trial will assess the effectiveness of~     administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with~     standard of care for postpartum hemorrhage treatment at the community level, primarily home~     births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar~     districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this~     setting is referral to a higher level health facility.~   "
148778|NCT01619059|"~     The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple~     combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes~     after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of~     this treatment will also be studied.~   "
148779|NCT01619046|"~     The purpose of this study is to assess the safety, efficacy and pharmacokinetics of~     GreenGene™ F in subjects with severe hemophilia A previously treated (> 150 exposure days)~     with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (Factor~     VIII).~   "
148780|NCT01619033|"~     This is an open, parallel group study in subjects with normal renal function compared to~     those with renal dysfunction.~   "
148781|NCT01619020|"~     Colorectal (CRC) cancer is the third most common cancer in the United States and its~     incidence is rising in younger populations. Diet seems to affect risk for CRC.~      Many parts of our diet are processed and modified by the microbes or bacteria in our gut.~     There are many different types of bacteria in our gut, each one of us has a community of~     different types and amounts of each type.~      When we eat flaxseeds, certain types of bacteria will process them - producing compounds that~     can then affect our body. How much of these compounds are produced by each person depends on~     the community of bacteria in the gut.~      Flaxseed and in certain nuts contain lignans, compounds that may have health benefits. Gut~     bacteria can convert the lignans into biologically active compounds that in animal models~     prevent the development of colon cancer. The investigators will study how these biologically~     active compounds affect colon cell-signaling pathways important to colorectal cancer risk.~      Results from our study will bridge the current knowledge from animal studies and~     epidemiologic studies and may help to inform approaches for future CRC prevention.~   "
148782|NCT01619007|"~     Following the findings of the clinical trials in drug development, this global~     non-interventional cohort field study will investigate rivaroxaban under clinical practice~     conditions in comparison with current standard of care for patients with acute deep vein~     thrombosis (DVT).~      The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of~     acute DVT in routine clinical practice.~   "
148783|NCT01618994|"~     A study to determine whether completing a rigorous simulation protocol could provide novice~     robotic surgeons with actual advanced surgical skills in an operating room setting.~   "
148784|NCT01618981|"~     The purpose of this study is to assess left atrial pacing therapy in patients with atrial~     dyssynchrony syndrome and heart failure with preserved ejection fraction.~   "
148785|NCT01618968|"~     Relative Bioavailability Comparison study~   "
148786|NCT01618955|"~     The purpose of this study is to assess the usability of the VIBEX MTX device for SC~     self-injection of methotrexate.~   "
148787|NCT01618942|"~     This study was conducted to explore the influencing factors, subjects and testers' evaluation~     about pain measurement with hand-held pressure algometer with different size probes.~     Methods:100 healthy undergraduate students(50 males and 50 females) were recruited into this~     study. Pain measurement including pressure pain threshold (PPT) and pressure pain~     tolerance(PTO) was carried out by the hand-held pressure algometer with different size probes~     (from 1cm2 to 0.01cm2) on three different measuring spots in right forearm. We recorded~     subjects' skinfold thickness, time per test procedure, types of pain perception, receptivity~     and degree of accuracy as well as testers' level of laborious.~   "
148788|NCT01618929|"~     -  To search the effects of montelukast on the airway inflammation including FEV1%,~          FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge~          tests, the leukotriene levels in the exhaled breath condensate in asthmatic children~          with and without food allergy aged 6-18 years old.~        -  To define the patient groups with good response to montelukast and to define the~          parameters which predict the good response.~   "
148901|NCT01617460|"~     The objective of this study is to investigate the safety and efficacy of aripiprazole orally~     administered over long term in subjects who complete a short-term treatment study of~     pediatric Autistic Disorder (031-11-002 study).~   "
148795|NCT01618838|"~     Radiation therapy is a well-established treatment modality for clinically localized prostate~     cancer. Men who choose to undergo radiation treatments for prostate cancer will have to live~     with the side effects for many years. Attempts have been made to protect surrounding tissues~     while delivering high dosage of radiation to cancer. With the rectum being so close to the~     prostate, many patients still suffer from side effects caused by radiation injury to the~     rectum, especially those who received conventional external beam radiotherapy.~      CyberKnife is an FDA approved radiosurgical devise. Its flexible robotic arm allows radiation~     beams to be delivered in different directions, providing a highly conformal, uniform dose~     with steep dose gradients. Therefore, treatment with the CyberKnife radiosurgical system~     should minimize the toxicity to the surrounding structures. CyberKnife System also~     incorporates a dynamic tracking system to allow the robot to correct the targeting of~     therapeutic beams during treatment. These improvements allow for dose escalation within the~     prostate with less normal tissue toxicity.~      The purpose of this study is to estimate the proportion of patients with endoscopically~     detectable telangiectasia as the indication of radiation injury to the rectum, after~     CyberKnife Treatment for prostate cancer.~   "
148796|NCT01618825|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fed~     condition in healthy adult human subjects.~   "
148797|NCT01618812|"~     In a group of children with severe and painful flatfeet lengthening procedures of calcaneus~     can be indicated. In this study the investigators use an artificial bone graft technique to~     avoid removing bone graft from the iliac crest.~   "
148798|NCT01618799|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy adult human subjects.~   "
148799|NCT01618786|"~     This study will evaluate the efficacy of novel compliant flooring in reducing injuries due to~     falls in a long-term care facility, determine the cost effectiveness of this intervention,~     and assess perceptions about compliant flooring among staff, residents, and families.~      The investigators hypothesize that compliant flooring will (1) reduce the incidence of~     injuries due to falls in long-term care residents; (2) represent an overall cost-savings when~     material and implementation costs are considered relative to direct and indirect costs~     associated with injuries due to falls; and (3) be received positively by staff, residents,~     and their family members.~   "
148800|NCT01618773|"~     This observational study is designed to assess the long-term efficacy and safety of Epiduo~     (alone or in combination with other drugs) under daily clinical practice conditions in~     patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on~     quality of life and patient adherence will be assessed under marketed conditions.~   "
148801|NCT01618760|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult human subjects.~   "
148802|NCT01618747|"~     This single-arm, open-label, multicenter, observational study will evaluate the efficacy and~     safety of Avastin (bevacizumab) in patients with glioblastoma multiforme in first or second~     relapse. Data will be collected from eligible patients initiated on Avastin treatment~     according to local label for up to 3 years.~   "
148803|NCT01618734|"~     TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP)~     who received alternatively romiplostim and eltrombopag.~   "
148804|NCT01618721|"~     The study seeks to characterize data obtained from patients with a variety of lung diseases~     using ultrasound Doppler signals obtained from lung tissue. A standard ultrasound device in a~     Doppler mode is placed on the chest wall and the unique software the investigators have~     developed analyzes the signals reflected from within the lung. On the basis of of pilot~     studies performed previously the investigators expect to receive different signals from~     different diseases that will enable diagnosis of different lung diseases.~   "
148805|NCT01618708|"~     The primary objective of this study was to demonstrate any changes in assessments of pain for~     participants receiving Synvisc-One compared to control.~   "
148806|NCT01618695|"~     The purpose of this study is to confirm the efficacy and safety of perampanel compared to~     placebo in patients with refractory partial-onset seizures~   "
148807|NCT01618682|"~     The investigators hope to gain insights into the functional organization of the human~     cerebral cortex in response to upper limb amputation and surgical interventions including~     hand replantation and hand transplantation.~   "
148808|NCT01618669|"~     The purpose of this study is to demonstrate that the strength of agreement between single~     photon emission computed tomography (SPECT) imaging with regadenoson following inadequate~     exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the~     strength of agreement between two sequential regadenoson SPECT images without exercise.~   "
148809|NCT01618656|"~     Cannabis dependence is associated with changes in the brain's cannabinoid system. When~     cannabis dependent individuals try to quit using cannabis, some of them experience problems~     that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the~     problems related to quitting cannabis may facilitate abstinence. One way to do this is by~     harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids.~     One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the~     problems related to quitting cannabis use will be reduced by increasing the brain levels of~     anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will~     be less likely to relapse. Brain anandamide levels will be increased by blocking the~     breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of~     a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied~     in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent~     subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The~     trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient~     treatment phase and a 8 week follow-up phase. Abstinence and relapse will be measured at~     various times during this 12 week study.~   "
148810|NCT01618643|"~     Acetic acid chromoendoscopy is an established standard technique used to detect dysplasia~     within the gastrointestinal tract. Acetic acid spray helps to identify neoplasia by~     highlighting the surface pattern, highlighting the vascular pattern and by a process known as~     the aceto-whitening reaction, where tissues take acetic acid and turn white for a brief~     period and then slowly revert back to a normal colour. The neoplastic surface and vascular~     pattern are all very well described, and have played a big role in the recognition of early~     cancer. The aceto-whitening reaction is well described but the differential in timing between~     neoplastic and non-neoplastic areas is not well understood.~      The investigators aim to establish the differential in the timing of the disappearance of the~     aceto-whitening reaction between healthy tissue, dysplastic tissue, intramucosal cancer and~     invasive cancer after acetic acid dye spray in the oesophagus and colon. By understanding~     this better, the investigators may be able to predict with greater accuracy whether a~     highlighted abnormal area is cancer or high grade dysplasia, or whether it is low grade~     dysplasia or inflammation, which has significant prognostic implications for the patient.~      The investigators hypothesize that the differential in the timing of the disappearance of the~     aceto-whitening reaction between normal and abnormal tissue could help in the detection of~     gastrointestinal neoplasia.~   "
148811|NCT01618630|"~     Severe burns result in persistent and extensive fat deposition in liver and muscle tissue.~     This may be related to the prolonged insulin resistance observed following burn. In this~     study the investigators will test the hypothesis that essential amino acids act in synergy~     with exercise to improve liver steatosis and muscle lipid metabolism, and thus also affect~     insulin sensitivity. Children with burns will participate in six weeks of exercise training~     with/without amino acid supplementation. Before and after the intervention, measurements will~     be done to determine muscle and liver fat content, muscle fat and protein metabolism, and~     insulin sensitivity.~   "
148812|NCT01618617|"~     Subjects will be screened and will enter a placebo-only 2-week run-in period during which~     constipation symptoms will be evaluated and any disallowed products (e.g. probiotics) must be~     discontinued. Following successful completion of the run-in period, subjects will be~     randomized to probiotic (high or low-dose groups) or placebo. Subjects will then consume~     their assigned product daily for 6 weeks. Subjects will undergo abdominal x-rays on study~     days 0 and 42 to assess transit time with each examination preceded by 6 days of radiopaque~     Sitz marker ingestion. Subject diaries will be used to collect bowel movement frequency,~     stool consistency, concomitant medications, and adverse events each day during the trial.~     Stool samples will be collected at baseline and end of study to assess fecal probiotic count.~     PAC-QOL, WCS, and GSRS questionnaires will be administered at baseline and day 42. 24-hour~     food recalls will be administered at day 0 and 42 and the following parameters will be~     assessed: total calories, carbohydrate, fat, protein, fiber, and liquid intake. Weekly~     physical activity recalls will be completed.~   "
148813|NCT01618604|"~     Conditioned Pain Modulation (CPM) is a phenomenon which isn't examined enough. Many factors~     of influence such as gender, age and psyche are already known - but the duration of such~     effects, their reliability and the correlation between standardized Quantitative Sensory~     Testing (QST) and CPM is still unknown.~      In this study the investigators expect to find parameters in QST that correlate with the~     efficacy of Conditioned Pain Modulation. Knowing factors that indicate high or low potential~     CPM could help finding patients-at-risk and adapting their therapy.~   "
148814|NCT01618591|"~     The purpose of the trial is to develop the evidence on relative efficacy of 3 available~     single-dose loperamide adjuncted regimens for watery diarrhea and a single-dose regimen, with~     and without loperamide, for dysentery/febrile diarrhea required for informing decisions among~     these regimens. Information from this study will be used to develop management guidelines for~     the diagnosis and management of travelers' diarrhea (TD) among deployed United States and~     United Kingdom military personnel.~   "
148815|NCT01618578|"~     The present study investigates by means of the rubber hand illusion body image stability and~     sense of body ownership in patients with CRPS of the upper limb compared to patients with~     unilateral pain of origin other than CRPS and age and sex-matched healthy subjects.~   "
148816|NCT01618565|"~     This trial tests whether hands-on training is superior to expert demonstration regarding the~     management of shoulder dystocia (stuck shoulder) during delivery on a training model.~   "
148817|NCT01618552|"~     This study will determine whether practicing primary care providers (PCPs) can be trained to~     support patient self-care of depression and co-existing diabetes during office visits, and~     begin to explore whether this might improve depression and diabetes outcomes, and whether the~     effects of the training generalize to patients with health conditions other than depression~     and diabetes. This is important because most patients with chronic conditions struggle with~     self-care and are seen in primary care, yet PCPs are seldom trained to support self-care.~   "
148818|NCT01618539|"~     General Anesthesia is usually produced by an intravenous agent and then maintained with a~     breathing agent till the surgery is completed. However, there is a recent trend to produce~     and maintain general anesthesia solely with an intravenous agent, such as propofol, in view~     of its advantages. This delivery method is called Total Intravenous Anesthesia (TIVA). The~     depth of general anesthesia can be measured by an anesthetic depth monitoring device called~     Bispectral Index (BIS). The use of BIS to determine the depth of anesthesia has been well~     established whenever a breathing agent is used to maintain general anesthesia. However, the~     validity of using BIS with TIVA has not been adequately investigated. This study will compare~     the BIS values at different doses of TIVA in order to establish any correlation between the~     two. If such a correlation is established, BIS monitoring can safely be recommended to~     determine anesthetic depth under TIVA.~   "
148819|NCT01618526|"~     Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have~     anti-inflammatory effects and to change the composition of the faecal micro flora in the~     colon.~      In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome~     are randomized to two types of diet intervention: a low and a high fiber diet. The~     participants are subjected to endoscopy before and in the end of each intervention.~   "
148902|NCT01617447|"~     The objective of this study is to investigate the efficacy and safety of aripiprazole orally~     administered over a period of 8 weeks in pediatric patients with Autistic Disorder~   "
148820|NCT01618513|"~     Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily~     used after insufficient surgical intervention, but also as primary medical treatment in~     selected patients. Evaluation of treatment control is based on monitoring blood levels of~     growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease~     control during SA treatment is not always straightforward. It is usually based on~     normalization of IGF-I and achievement of a certain GH level. In approximately 40% of~     patients discordant values of GH and IGF-I levels are seen after treatment with SA, with~     normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation is~     unknown, but it indicates that SA may affect this difference.~      The primary objective of this study is to investigate if disease control during SA treatment~     is best achieved by monitoring either GH or IGF-I.~   "
148821|NCT01618500|"~     A novel computerised neuropsychological test battery for normal pressure hydrocephalus (NPH)~     has been developed. The aim is to provide the clinician with a free of charge, standardized~     tool, assessing the cognitive decline or improvements in the cognitive domains specific for~     NPH. Results from the battery indicate good reliability and validity for the computerized~     tests~      Results from the computerised battery seems promising. However, ability for the battery to~     detect cognitive improvements after a shunt operation remains to be tested.~      Study objectives~        1. Improvement after shunt. The aim of this study is to evaluate the effects of shunting on~          neuropsychological performance in NPH patients, using a computerized battery.~        2. Feasibility. The ability to complete the test battery by the intended patient group will~          be tested.~        3. Baseline profile. Baseline scores for NPH-patients will be compared to scores of healthy~          individuals (from previous study).~   "
148822|NCT01618487|"~     The investigator hopes to determine if one of three current standard of care surgeries for~     lateral epicondylitis (tennis elbow) is more effective than others. The three surgeries are:~     arthroscopic tenotomy, open tenotomy, and debridement and repair.~   "
148823|NCT01618474|"~     This trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel plus~     capecitabine)and XELOX (oxaliplatin plus capecitabine)as adjuvant chemotherapy for stage~     IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the~     optimal adjuvant regimen for such extremely high risk patients.~   "
148824|NCT01618461|"~     Research shows that well-developed icons and other pictorials aid in the comprehension of~     medication information and are effective in improving patients' medication management. This~     experimental study seeks to test the effect of icons and structured medication information on~     subjects' processing and recall of simulated medication instructions in a computer testing~     environment. The study planned to enroll 200 subjects.~   "
148825|NCT01618448|"~     A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy~     and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients with Heart~     Failure~   "
148826|NCT01618435|"~     The average life expectancy in Denmark is increasing resulting in an increasing part of the~     population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes~     constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back,~     especially when standing and walking, known as neurogenic claudication(Goh KJ FAU - Khalifa~     et al.). LSS occurs in a combination of degenerative changes in the lower back, including~     hypertrophy of the ligamentum flavus, arthrosis of the facet joints and bulging of the disc.~      Current treatment of LSS is varied ranging from non-operative conservative treatment to~     operation.~      Operative intervention shows very good results according to physical ability and~     pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.),~     but the most optimal treatment is still debated. Nevertheless, a decompression and, if~     needed, a spinal fusion is recommended.(Ausman).~      Clinical improvement including decrease of pain, improved ADL-function and an increased~     quality of life are parameters of highest interest and the purpose of an operation is clear:~     Making sufficient room for the affected nerves. In addition fusion is desired achieving~     stability avoiding a new compression of the nerves. Studies attending these issues find a~     correlation between fusion and clinical outcome, why obtained fusion of the affected levels~     are very important(Andersen et al.;Andersen et al.;Girardo et al.;Kornblum MB FAU -~     Fischgrund et al.).~      P-15, bound to Anorganisk Bone Mineral (ABM), called i-FACTOR®, shows fusion superiority, no~     side effects and no risk of transferring disease(Thorwarth et al. 5648-57;Thorwarth et al.~     789-95;Wenz, Oesch, and Horst 1599-606;Scarano et al. 318-24;Kubler et al. 171-79) why the~     investigators find this material suited for fusion surgery in the elderly.~      To the investigators knowledge this is the first prospective study comparing fusion rates and~     postoperative clinic with i-FACTOR vs allograft in older patients operated with decompression~     and spondylodesis because of spinal stenosis due to degenerative spondylolisthesis.~      Hypothesis:~      There are no difference in the clinical parameters measured by ODI and fusion rates comparing~     i-FACTOR® and allograft in non-instrumented posterolateral spondylodesis-operations in~     patients 60 years and older.~   "
148827|NCT01618422|"~     This is a prospective, randomized, parallel, controlled study comparing the efficacy and~     outcomes in the retreatment of pulmonary Tuberculosis (TB) in Guangzhou in a group using~     pretreatment susceptibility tests in selection of chemotherapy regimens and that in another~     group without using pretreatment susceptibility test results. The investigators hypothesize~     that selecting drug treatment on the basis of known susceptibility tests would lead to~     improved outcome compared with empiric treatment.~   "
148828|NCT01618409|"~     The purpose of this randomized controlled trial is to evaluate the effect of Spanish-language~     illustrated medication instructions (PictureRx cards), compared to traditional medication~     instructions, on Latinos' understanding of their medication regimens. The study will also~     assess the effect on self-reported medication adherence. Patients with diabetes who attend~     participating clinics are eligible. The target sample size is 200.~   "
148829|NCT01618396|"~     Previous studies have demonstrated that altered microvascular blood flow is an important~     marker of severe sepsis. Usually, these patients need invasive ventilatory support, frequent~     use of sedatives and it is unknown if these agents interfere or not on microvascular blood~     flow. The goal of this study was to compare effects of propofol and midazolam infusions on~     sublingual microcirculation of septic shock patients.~   "
148830|NCT01618383|"~     The clinical and pathological similarities between LRRK2 related parkinsonism and idiopathic~     Parkinson's disease (PD) indicate that monogenetic LRRK2 parkinsonism may be a paradigm for~     the development of Lewy bodies disease, and a careful look at discrepancies between these two~     conditions may provide insight into the pathogenesis of PD. The early involvement of the~     enteric nervous system (ENS) during PD led to theories that an as yet unidentified external~     agent entering the ENS causes PD . If lesions of the ENS are found in patients who present~     with a genetic form of parkinsonism would go against this notion, and thus provide insight to~     the pathophysiology of the disease.~   "
152577|NCT01569230|"~     The purpose of this study is to verify the efficacy and safety of acupuncture treatments~     (Individualized, Standardized acupuncture) for patients with knee osteoarthritis (OA).~   "
148832|NCT01618357|"~     The investigators' primary aim is to determine the number of participants who can handle the~     treatment within specific safety parameters, determine the number of participants who can~     handle safely the maximum tolerated dose (MTD) (within 50-200 mg/BID dose range) when~     combining Veliparib and radiation, as well as to identify side effects and their intensity at~     different dosing levels.~      The investigators' secondary aim is to determine the number of participants with~     post-operative adverse events associated with POPI as well as the pathologic complete and~     partial response rate in patients treated with POPI.~      The investigators' exploratory aim is to serially assess apoptosis/proliferation biomarkers,~     and gene and protein expression profiles for correlation with tumor response to POPI. This~     will be primarily evaluated in the expansion cohort.~      Study Plan:~      It will be a standard 3+3 dose finding trial in which the MTD will be defined as the dose~     below the level at which >1 DLT is observed in 3-6 patients. Women with node positive disease~     prior to NAC and >1.0 cm residual breast disease and/or clinically positive nodal disease~     after NAC will be offered participation in the research phase of this study.~      Women with residual disease >1cm or +LN after NAC (Med Onc's choice) will be offered~     pre-operative Veliparib and concurrent whole breast and regional nodal irradiation. Four (4)~     dose levels of Veliparib will be evaluated with concurrent whole breast and regional nodal~     irradiation (WB/RNI). The starting dose of Veliparib will be 50 mg BID, will increase in 50~     mg increments to a maximum of 200 mg BID and be delivered concurrently with 235 cGy QD x 16~     to the breast and SCV/Axilla. Once the MTD is determined we will further evaluate safety with~     an expansion cohort which will bring the total number of patients treated at the MTD to 20.~      Accrual: Up to 44 patients~   "
148833|NCT01618344|"~     To explore use of a smart-phone medication reminder application to promote adherence to oral~     medications by AYA with cancer.~   "
148834|NCT01618331|"~     The hypotheses is that regular post exercise supplementation increase fitness and daily~     activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy.~      All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen~     consumption and 6MWT is used as primarily effect goals. Secondary effect goals are risk of~     falls and daily activity level.~   "
148835|NCT01618318|"~     In the past, doctors separated people with asthma into two groups, those with allergic~     asthma (about 2/3rds of people) and those with non-allergic asthma. These labels are not~     much used now as the treatments for all people with asthma don't depend on this~     classification. However, new treatments for asthma may become available and the~     classification may again become important. It could be useful for clinicians to know how to~     identify which patients are likely to benefit from particular treatments.~      Additionally, some new blood tests are becoming available and some of these might help to~     categorise the type of asthma people have. What the study hopes to do is to identify patient~     features which make a diagnosis of allergic asthma more likely and to see which new blood~     tests are most likely to be helpful in confirming this diagnosis.~   "
148836|NCT01618305|"~     HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late~     stages of pregnancy need an effective medication regimen to reduce the risk of transmitting~     HIV to their children. This study will examine the virologic response, safety, and~     tolerability of two different ARV medication regimens in HIV-infected pregnant women who are~     between 20 and 36 weeks pregnant when they enter the study.~   "
148837|NCT01618292|"~     Compare changes in bowel function before, 6 months and one year after Robotic-assisted~     laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one~     year after Robotic-assisted laparoscopic sacral colpopexy.~   "
148838|NCT01618279|"~     The main aim of this study will evaluate differences in serum levels of tryptase in study~     population. Will be selected a number of 350 patients hospitalized for coronary heart~     disease.~   "
148839|NCT01618266|"~     Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.~   "
148840|NCT01618253|"~     To determine the maximum tolerated radiation dose with concurrent sorafenib for unresectable~     hepatocellular carcinoma that has not responded to transarterial chemoembolization.~   "
148841|NCT01618240|"~     First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators~     hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the~     ability to protect the airway during swallowing in long-term ventilated subjects. More~     specifically, the investigators hypothesized that low muscle strength is associated with the~     inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus~     residue scale (VPSR scale [NRS: 0-4] of > 1) and entering the materials into airway (PAS~     scale [1-8]> 1), which should predispose to endotracheal aspiration.~   "
148842|NCT01618227|"~     Loss of wrist flexion and extension is a common problem after wrist and forearm fractures~     that may lead to disability and unsatisfactory outcomes after fracture treatment. In many~     patients, this range of motion loss is caused by stiffness of the soft tissues. Such~     stiffness may loosen up and improve with rehabilitation. Static progressive splints apply a~     constant stretch upon the wrist resulting in a stretch relaxation and plastic deformation of~     the soft tissues. By altering the splint's bending angle, one can incrementally increase the~     force applied on either wrist flexion or extension. There are no data comparing~     rehabilitation with static-progressive splinting to rehabilitation without static-progressive~     splinting for the restoration of wrist flexion and extension after wrist or forearm~     fractures.~      Primary study hypothesis:~      Two months after study enrollment patients that use static progressive splinting have better~     wrist flexion and extension than patients that use standard therapy techniques.~      Secondary study hypotheses:~        1. Six months after study enrollment, subjects that use static progressive splinting have~          better wrist flexion and extension than those that use standard therapy techniques.~        2. Motion at enrollment, 2 months and 6 months after enrollment correlates with negative~          pain thoughts, pain anxiety, and depression.~        3. Six months after study enrollment, subjects that use static progressive splinting have~          had fewer physical/occupational therapy visits than those that use standard therapy~          techniques.~        4. Six months after study enrollment patients that use static progressive splinting have~          had fewer additional surgeries than patients that use standard therapy techniques.~      This study will employ a prospective randomized design. Subjects will be invited to enroll~     during their routine office follow-up visit. Informed consent will be obtained. Subjects will~     be randomized on a 1:1 ratio to rehabilitation with or without static progressive splinting.~      All subjects will have a standard rehabilitation program including physical or occupational~     therapy and home exercises throughout the study. The static progressive splint will be~     prescribed according to the randomization sequence. Upon receipt of the splint, subjects will~     be instructed in proper application and use by their treating therapist or a representative~     of the company. Subjects will be instructed to follow the daily splint wearing protocol~     provided by the device manufacturer. Use of the splints will be discontinued at the patient's~     discretion or when a plateau phase in active range of motion is achieved (defined as no~     measurable gains in active range of motion achieved in a 30-day period).~   "
148843|NCT01618214|"~     This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily~     individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the~     investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2~     diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD~     background treatment: Metformin plus/minus alpha-glucosidase inhibitor.~   "
148844|NCT01618201|"~     Migraine is prevalent in 10-12% of the population. It involves the development of a cranial~     perivascular neurogenic inflammation. Recent information suggests that migraine might be a~     risk factor to stroke. The possible mechanisms that might relate migraine and stroke are: 1.~     Migraineous infarction 2. A primary endothelial disorder. 3. Genetic relation 4. An ongoing~     inflammatory process. C reactive protein (CRP) is a sensitive marker for an inflammatory~     process.The data on the relation of migraine to inflammation is limited. The aim of the~     current study is to assess inflammatory factors as possible markers for migraine.~   "
148845|NCT01618188|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in~     subjects with type 1 diabetes.~   "
148846|NCT01618175|"~     Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all~     population groups, and is usually due to respiratory syncytial virus (RSV) infection. The~     main cause for hospitalization is often a need for oxygen, but can also include high fever~     (with a suspected secondary bacterial infection) or increasing respiratory distress. In a~     minority of cases (some of which can be identified in advance by defining risk groups) a~     serious illness may develop, including risk of respiratory failure and death. Most cases will~     just require supplemental oxygen and suction of secretions from the nose (as listed in the~     recommendations of the American Academy of Pediatrics - AAP). However, this apparently~     simple treatment still requires continued hospitalization. This results in a sharp increase~     in bed occupancy in Israeli hospital pediatric departments in the winter months. In recent~     years two studies from developed countries have been published where safety has been~     demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have~     not been published yet, for example for populations living in poor conditions. The General~     Health Services (Klalit) in Israel provides integrated hospital and community health service~     to the majority of the population living o in our region, thus presenting an opportunity for~     optimal interventions related to this disease.~   "
148847|NCT01618162|"~     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of~     this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in~     insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in~     combination with metformin. All subjects will continue their pre-trial SU treatment with or~     without metformin treatment without changing the frequency or dose throughout the trial.~   "
148848|NCT01618149|"~     The investigators hypothesized that the microarchitecture of bone influence the degree of~     periprosthetic bone loss after total knee arthroplasty surgery. The investigators collected~     the bone fragment at the distal femur while performing total knee replacement and take~     quantitative radiography analysis . Before and after the surgery(6 month ,12 month) , the~     investigators check the BMD at identical location of the distal femur by using dual energy~     absorptiometry. The investigators will use linear regression to evaluate the relationship~     between the microarchitecture and the degree of bone loss.~   "
148849|NCT01618136|"~     Overall Design: This is a multicenter, open-label, Phase 1/2 study which will be conducted in~     three arms (as described below). Each arm will be conducted in two parts: a Phase 1 part~     which will include dose escalation and a Phase 2 part which will include four cohorts in~     specific disease indications. Phase 1 will also include a food effect study of E7449 as a~     single agent. Once the MTD in the Phase 1 single agent arm and the Phase 1 combination arms~     of this study has been achieved, the sponsor will submit the relevant safety information and~     recommended Phase 2 dose to the IRB/Health Authorities. Arm 1: E7449 will be administered as~     a single agent. Arm 2: E7449 will be administered in combination with TMZ. Arm 3: E7449 will~     be administered in combination with carboplatin and paclitaxel~   "
148850|NCT01618123|"~     It is recognized that endothelial dysfunction is a major factor contributing to the~     atherogenic process. Abnormal function of the endothelium is detectable prior to obvious~     intimal lesions in patients with risk factors for atherosclerosis. Endothelial dysfunction is~     a systemic disorder and a key variable in the pathogenesis of atherosclerosis and its~     complications. Measurement of peripheral vasodilator response with fingertip peripheral~     arterial tonometry (PAT) technology (EndoPAT; Itamar Medical, Caesarea, Israel) is emerging~     as a useful method for assessing vascular function. EndoPAT may be a potential valid test~     increasing the accuracy, sensitivity and specificity for detection of subjects to chest pain~     unit (CPU) with chest pain but no obvious coronary artery disease (CAD). This is a relatively~     fast non-invasive bedside test, relatively low-cost and has no side effects. Therefore, the~     primary objective of the study is to test the hypothesis that abnormal endothelial function~     as assessed by EndoPAT testing will increase the prediction of the short (in-hospital) and~     long-term (1-year) outcome of patients presenting to the chest pain unit.~   "
148851|NCT01618110|"~     -  ADHD is one of the most common psychiatric disorders.~        -  While most of the attention is directed towards youth, 60% continue to suffer symptoms~          into adult life.~        -  Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are~          non-responders.~        -  Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially~          at right PFC.~        -  It is this study hypothesis that by stimulating the right PFC by TMS, it will be~          possible to alleviate ADHD symptoms.~        -  A 10 sessions of treatment will by applied on a randomly allocated group of patients,~          diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS~          treatment, and the second group will receive a sham treatment.~        -  Improvement of objective and subjective ADHD scale will be examined.~   "
148852|NCT01618097|"~     The purpose of this study is to advance the evidence base regarding methods for facilitating~     informed decisions among patients with knee and hip osteoarthritis by comparing DVD and~     online formats of decision aids for these conditions. The project will assess how these~     different formats impact key outcomes including: patient knowledge about treatment options,~     decisional conflict, preparation for decision making, decision self-efficacy, stage of~     decision making, and acceptability and usability of the decision aids.~   "
148853|NCT01618084|"~     The Trident Tritanium acetabular component of a total hip prosthesis is a new developed~     uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup~     will be compared with the Trident HA acetabular component in two equal sized groups. The~     Symax HA coated stem will be used as femoral component in both groups.~      Study Objectives:~        -  The primary objective is to determine the prosthetic migration of the uncemented~          acetabular and femoral total hip components using model based RSA technique~        -  Secondary objectives are on one hand to assess clinical outcome on the other hand~          assessing patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score,~          WOMAC, and EQ-5D questionnaires~        -  Tertiary objective is to assess bone remodeling of the uncemented acetabular components~          and the HA-coated Symax hip stem using QCT derived from usinf F18-fluoride PET in a~          cohort of 12 consecutive patients of this RCT~      A total of 50 patients will be enrolled in this RCT divided into two equal groups. Patients~     have to fulfill the inclusion and exclusion criteria.~      All evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery~     at 4 weeks, 3 and 6 months and 1 and 2 years.~   "
148854|NCT01618071|"~     Many types of cardiovascular disease begin when the layer of cells lining blood vessels~     (endothelial cells) start to function abnormally. This causes white blood cells (monocytes)~     to enter the blood vessel wall and eventually form lesions. Fats from foods we consume are~     carried in the blood for 3-8 hours after a fatty meal in small particles known as~     chylomicrons (CM) and chylomicron remnants (CMR). The overall aim of this project is to~     investigate the idea that n-3 polyunsaturated fatty acids (PUFA) protect against heart~     disease by modifying the effect of CMR on endothelial cells and monocytes. We hypothesize~     that n3-PUFA carried in CMR reduce detrimental events which promote blood vessel damage and~     activate protective mechanisms to improve the function of arteries.~   "
148855|NCT01618058|"~     The purpose of this trial is to determine if exposure to ARV-containing investigational~     products in IPM clinical trials will impact the natural history of HIV infection as measured~     by the virologic, immunologic and clinical outcomes of participants who become HIV-positive~     during the IPM 027 trial.~   "
148856|NCT01618045|"~     Fermented Papaya Preparation (FPP) is a sweet and granular substance available over the~     counter. FPP possesses antioxidant properties, which provide benefit against age-related~     complications, and is also known to protect red blood cells (RBCs) against oxidative damage~     and to help protect against severe forms of thalassemia. The investigators recently showed~     that ex vivo supplementation of FPP can correct respiratory burst performance of diabetic~     peripheral blood mononuclear cells (PBMC) via a Sp-1 dependant pathway. Based on these~     observations, the investigators propose to study the outcome that FPP supplementation has in~     patients with diabetes.~   "
148857|NCT01618032|"~     Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability~     (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries.~     Passive mobilization techniques to improve ankle dorsiflexion are commonly used in~     physiotherapy treatments. However, no studies have compared manipulative techniques of~     mobilization techniques in subjects with chronic ankle instability.~      The aim of this study is to compare the effects of two mobilization techniques on ankle~     dorsiflexion in patients with chronic ankle instability.~   "
148858|NCT01618019|"~     The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid~     (PUFA) can be beneficial for the patients with rheumatoid arthritis.~   "
148859|NCT01618006|"~     Cardiac bypass surgery is an important treatment for patients with severely blocked arteries~     (tubes that delivery oxygen and nutrients to the heart). Hundreds of thousands of these~     operations are done each year to help relieve patients' chest pain and to prevent future~     heart attacks. The surgery is done by bypassing blood flow around badly clogged arteries by~     sewing on healthy vessels from another part of the body (usually from the leg or the chest).~     Aspirin (a blood thinner) is given to patients once a day after their surgery because it~     stops sticky cells in the blood (platelets) from blocking these new vessels (which may lead~     to a future heart attack).~      Research has shown that aspirin does not work as well in people after they have bypass~     surgery as the investigators might expect (for reasons that are not fully understood). One~     reason aspirin may not work as well after surgery is because the body makes many more~     platelets after surgery than it would under normal circumstances. All of these new platelets~     overwhelm the aspirin and continue to be sticky and ready to block off arteries. The~     investigators believe that giving multiple daily doses of aspirin following bypass surgery is~     more effective than giving aspirin once daily at blocking platelet activity.~   "
148860|NCT01617993|"~     User questionnaire of Eeva System usability and reports of device malfunctions.~   "
148861|NCT01617980|"~     Radiotherapy, preferably combined with chemotherapy, is the treatment standard for locally~     advanced, unresectable non-small cell lung cancer (NSCLC). The tumor response to different~     therapy protocols is variable, with hypoxia known to be a major factor that negatively~     influences treatment effectiveness. Visualisation of tumor hypoxia prior to the use of modern~     radiation therapy strategies, such as intensity modulated radiation therapy (IMRT), might~     allow higher dose applications to the target volume, leading to improvement of therapy~     outcome. 18F-fluoromisonidazole dynamic positron emission tomography and computed tomography~     (18F-FMISO dPET-CT) and functional magnetic resonance imaging (functional MRI) are attractive~     strategies for imaging tumor hypoxia. The HIL trial is a single centre pilot study combining~     multimodal hypoxia imaging with 18F-FMISO dPET-CT and functional MRI and intensity modulated~     radiation therapy (IMRT) in patients with inoperable stage III NSCLC. 15 patients are~     recruited in the study. All patients undergo serial 18F-FMISO dPET-CT and functional MRI~     before treatment, at week 5 of radiotherapy and 6 weeks post treatment. Radiation therapy is~     performed as inversely planned IMRT after four dimensional computed tomography (4D-CT) based~     target volume definition. Hypoxia imaging is not included in target volume definition or IMRT~     dose prescription.~      Objectives of the trial are to characterize the correlation of 18F-FMISO dPET-CT and~     functional MRI for tumor hypoxia imaging in NSCLC and evaluate possible effects of radiation~     therapy on tumor re-oxygenation. Further objectives include the generation of data regarding~     the prognostic value of 18F-FMISO dPET-CT and functional MRI for locoregional control,~     progression free survival and overall survival of NSCLC treated with IMRT, which will form~     the basis for larger clinical trials focusing on possible interactions between tumor~     oxygenation and radiation outcome.~   "
148862|NCT01617967|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple doses of ALN-TTR02 in patients with transthyretin (TTR) mediated~     amyloidosis (ATTR).~   "
148863|NCT01617954|"~     This is a prospective study that will assess the impact of MammaPrint on chemotherapy +~     endocrine versus endocrine alone treatment decisions in patients with an Oncotype~     Intermediate Score.~   "
148864|NCT01617941|"~     It will provide a first evaluation of efficacy, safety and tolerability of BGG492 in patients~     with non-chronic migraine having more than 3 and less than 12 migraine attacks per 4 weeks.~   "
148865|NCT01617928|"~     This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) .~     Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine~     the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination~     with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives~     are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in~     the subjects.~   "
148866|NCT01617915|"~     In 2011, there was an estimated 233,000 cases of invasive breast cancer, and 39,970 deaths~     from breast cancer in the United States. The vast majority of patients are diagnosed with~     Stage I-III resectable and potentially curable disease, and for these patients, the most~     pressing questions are whether adjuvant endocrine or chemotherapy are indicated, and if so,~     how to determine whether these treatments are working. Adjuvant systemic therapy reduces~     relative recurrence rates by 30-50%, depending on the age of the patient and tumor~     characteristics. However, patients with early stage disease often do not bear measurable~     markers of disease such as an elevated cancer antigen 27-29 (CA27.29) or circulating tumor~     cells. Patients with early stage breast cancer are typically treated with adjuvant therapy~     based on historical evidence showing that such therapy prolongs survival in this population.~      Lung cancer is the most common malignancy and the leading cause of cancer-related death in~     the U.S. Approximately 220,000 new cases of lung cancer are diagnosed in the U.S. every year.~     Unfortunately, lung cancers are often diagnosed at later stages than breast cancer, due in~     part to little/no effective screening for lung cancer. As with breast cancer, patients are~     commonly treated with chemotherapeutic agents, but treatment regimens can take several weeks~     to months to elicit clinically detectable anti-tumor effects. A biomarker to assess early~     tumor response to therapy would benefit this patient population.~      The contents of dying tumor cells can be detected in the bloodstream, and this may be~     enhanced by the leaky vasculature of solid tumors. Protein biomarkers of tumor cell death are~     difficult to detect due to the complex nature of plasma and the lack of technical~     sensitivity. In contrast, DNA is easier to detect through polymerase chain reaction (PCR)~     amplification. Indeed, circulating tumor DNA has been detected in plasma from patients with~     osteosarcoma, breast cancer, and colorectal cancer. Until recently, it was impractical to~     develop an assay to routinely quantify circulating tumor DNA due to heterogeneity between~     patients and tumors. Advances in genomic technology now permit sequencing a tumor genome to~     identify patient-specific genomic aberrations. Major genomic alterations (i.e., insertions,~     amplifications, deletions, inversions, translocations) can be readily detected using PCR~     primers which will recognize tumor DNA but not normal DNA.~      While this strategy may be generally applicable to diverse types of solid tumors, two issues~     are apparent in breast cancer. Firstly, the incidence of chromosomal rearrangements varies~     widely. Whole-genome sequencing of 15 breast tumors revealed a range of 1-231 major genomic~     alterations (mean= 68), where 2 tumors had 1 alteration, and 9 tumors had > 20 alterations.~     Single-base point mutations are more common but difficult to reliably detect using PCR.~     Therefore, the investigators must consider that a small subset of patients may have a limited~     number of genomic alterations available for this assay. Secondly, intratumoral heterogeneity~     may mean that some genomic alterations are not present in every tumor cell. Such~     heterogeneity has been inferred from FISH and immunohistochemistry (IHC) studies for many~     years, and is now being verified at the genomic level. The investigators must consider that~     only a subpopulation of tumor cells may be sensitive to cytotoxic therapy, so changes in the~     levels of circulating tumor DNA may only be reflected with analysis of genomic alterations~     specific to the sensitive cells.~   "
148867|NCT01617902|"~     This study aims to evaluate the incidence and risk factors of hyperbilirubinemia following~     major cardiac or thoracic aorta surgery, and to determine the clinical impacts of the~     hyperbilirubinemia on postoperative mortality and morbidity.~   "
148868|NCT01617889|"~     The objective is to assess the comparative fat and calcium absorption, and gastrointestinal~     (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing~     different fat blends.~   "
153354|NCT01559051|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the health of patients with human Chronic~     Obstructive Pulmonary Disease.~   "
148869|NCT01617876|"~     When performing screening endoscopy, small focal gastric lesions are frequently encountered.~     Novel techniques in endoscopy, such as magnifying endoscopy (ME) with narrow-band imaging~     (NBI) and chromoendoscopy with acetic acid-indigocarmine mixture (AIM), are developing to~     enhance images of gastrointestinal tumor. Furthermore, observation of the microstructures of~     gastric mucosa by ME, including microvascular pattern and microsurface pattern, has been~     proposed in the recognition of early gastric cancer (EGC).~      This study is based on the hypothesis as follow:~        1. The microvascular structure could be clearly observed with magnifying endoscopy enhanced~          by narrow-band imaging (ME-NBI).~        2. The microsurface architecture could be clearly observed with magnifying endoscopy~          enhanced by acetic acid-indigocarmine mixture (ME-AIM).~        3. Enhanced ME (combining ME-NBI and ME-AIM), as compared to white-light endoscopy (WLE),~          has higher sensitivity and specificity for the differential diagnosing small focal~          gastric lesions.~   "
148870|NCT01617863|"~     The purpose of this study is to determine in soccer fans whether and to which extend positive~     or negative emotions during the European soccer Championship affects Central Hemodynamics,~     Arterial Stiffness, Heartrate and Endothelial Dysfunktion.~   "
148871|NCT01617850|"~     Physical rehabilitation is a key element in the treatment of patients with cardiovascular~     diseases, and recent evidence has shown that supervised exercise programmes can prevent~     cardiovascular events, improve physical function and quality of life. Individualized exercise~     prescription based on appropriate frequency, intensity and duration is recommended.~     Furthermore, recent studies have shown that physical cardiac exercise training can influence~     inflammation of the vessel wall and hence reduce development of arteriosclerosis in coronary~     vessels. In the literature are divergent conclusions on appropriate frequency and duration of~     physical rehabilitation programs in order to improve physical function and reduce~     arteriosclerosis.~      The purpose of this study is to investigate the efficacy of an optimized physical~     rehabilitation programme compared to a conventional programme on physical fitness, health~     related quality of life and vascular inflammation.~   "
148872|NCT01617837|"~     The aim of this study is to investigate if P6 acupressure may reduce postoperative nausea and~     vomiting in neurosurgical patients undergoing craniotomy.~   "
148873|NCT01617824|"~     Diabetes mellitus is characterized by chronic low grade inflammation, which is worsened by~     the co-existence of renal failure.~      One key aspect of chronic inflammatory diseases is the alteration in the polarization profile~     of circulating monocyte-macrophage cells.~      Namely, monocytes-macrophages can exist in a pro-inflammatory (M1) polarized form or an~     anti-inflammatory (M2) polarized state. Alterations in the M1/M2 balance is thought to~     contribute to inflammation within atherosclerotic lesions and visceral adipose tissue which,~     in turn, can worsen cardiovascular disease and metabolic features in type 2 diabetic~     patients.~      M1 and M2 are regulated by a complex interplay of soluble signaling molecules, many of which~     are substrate of the enzyme DPP-4 (dipeptidyl peptidase-4). Therefore, inhibition of DPP-4~     can affect the M1/M2 polarization balance.~      In this clinical trial, the investigators will test whether the DPP-4 inhibitor Linagliptin,~     compared to placebo, modifies the M1/M2 balance in type 2 diabetic patients with and without~     chronic renal failure.~      In addition, we will test whether DPP-4 inhibition with Linagliptin acutely affects~     endothelial progenitor cells (EPCs), which are vasculoprotective cells implicated in the~     pathobiology of diabetic complications.~   "
148874|NCT01617811|"~     The purpose of this study is to analyze the effects of epidural anesthesia and analgesia on~     intraoperative clinical outcome, postoperative recovery, metabolic changes, and immune~     functions of the patients receiving open liver resection.~   "
148875|NCT01617798|"~     Patients who are on mechanical ventilation in an intensive care unit often require diursis as~     part of their pre-extubation regimen. The drug of choice for diuresis has traditionally been~     furosemide. However, this drug cause hypernatremia (a rise in serum sodium) in a significant~     proportion of patients. Hypernatremia is traditionally treated by providing free water~     supplementation to the patient. This strategy creates a vicious and unproductive cycle of~     giving free water, and then diuresing it off. We propose a strategy for breaking this cycle~     by using a second diuretic-- metolazone-- which has a tendency to rid the body of more~     sodium, thereby minimizing hypernatremia.~   "
148876|NCT01617785|"~     Coronary heart disease (CHD) pose a serious health threaten to population. Optimal~     revascularization strategy in multiple vessel coronary artery disease patients remains a~     subject of debate between interventional cardiologists and surgeons. Knowledge about the~     real-life revascularization pattern and outcomes in China is limited. By consecutively~     recruiting three vessel coronary heart disease patients in 23 geographically representative~     highest-rank hospitals, this study will examine revascularization strategy, and various~     real-life factors, that may affect patients lone-term recovery. Practical guidelines,~     appropriateness criteria and quality evaluative system for revascularization strategy will be~     established based on the findings, to improve patients outcomes in future finally.~   "
148877|NCT01617772|"~     The aim of the present study was to compare the effects of simvastatin and L-carnitine~     coadministration versus simvastatin, L-Carnitine monotherapy on liver transaminases and liver~     elasticity in NASH patients.~   "
148878|NCT01617759|"~     Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in~     immunocompromised patients. Confirming the diagnosis is rarely accomplished as invasive~     procedures are hampered by neutropenia and low platelet count. Cerebrospinal fluid (CSF)~     cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for~     improving diagnostics. Therefore the performance of an established Aspergillus-specific~     nested PCR in CSF samples of immunocompromised patients with suspicion of CNS IA will be~     evaluated.~   "
148879|NCT01617746|"~     The purpose of this study will be to determine if blockade of endothelin 1 signalling via~     endothelin receptor A using ambrisentan or dual blockade (A&B) via bosentan can provide~     protection against methacholine induced bronchoconstriction in asthma.~   "
148903|NCT01617434|"~     This trial is conducted in Asia, Europe and North and South America. The aim of the trial is~     to investigate the effect of liraglutide versus placebo when added to basal insulin analogues~     with or without metformin in subjects with type 2 diabetes.~   "
149035|NCT01615705|"~     The purpose of this study is to evaluate whether biomarkers of inflammation, genetic~     thrombophilia and coagulation activation influence Post-Thrombotic Syndrome development in~     patients with symptomatic proximal deep venous thrombosis.~   "
148880|NCT01617733|"~     Nelson's syndrome, an expanding pituitary tumour, occurs in up to 30% of adults after~     bilateral adrenalectomy for Cushing's disease, for which no medical treatment exists. Plasma~     Adrenocorticotrophic hormone (ACTH) levels in these patients remain high, they are~     characteristically deeply pigmented, and may experience neurological effects as a consequence~     of the tumour. It is not known whether the tumour growth is due to the lack of cortisol~     feedback after adrenalectomy or whether the pituitary cells were preprogrammed to develop~     into a tumour.~      There is a real need for an effective medical management for Nelson's syndrome. This is~     especially true given the increasing data on the somewhat disappointing longterm outcome of~     transsphenoidal surgery, and the increasing use of aparoscopic bilateral adrenalectomy for~     failures of pituitary surgery or even as primary therapy for Cushing's disease. Therefore, it~     is likely that there will be increasing numbers of patients attending endocrine centres~     worldwide with Nelson's syndrome following bilateral adrenalectomy as part of their~     management for Cushing's disease. In view of this it is important to investigate all~     potential avenues for the treatment of Nelson's syndrome and translate any benefits to~     patients.~      This study, designed and initiated by the investigators, will assess if pasireotide reduces~     ACTH levels and tumour volume in patients with Nelson's syndrome. Patients will be recruited~     for a period of 32 weeks and receive 4 weeks of pasireotide twice daily and then 24 weeks of~     pasireotide long acting release therapy every 4 weeks. Over the 32 week protocol patients~     will make 12 visits for serial ACTH blood measurements and have 2 MRI scans to assess tumour~     volume.~   "
148881|NCT01617720|"~     This Study is designed to observe the clinical outcomes of patients requiring mitral repair~     that were treated with the CE certified Cardinal System.~   "
148882|NCT01617707|"~     Sedative endoscopic examination using sedative premedication has been undertaken to induce~     conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely~     used as a sedative premedication because it has lots of advantages, such as a short~     half-life, a faster onset of sedation and an excellent sedative hypnotic effect. However,~     midazolam has been used regardless of whether or not alcohol although using midazolam in~     chronic alcoholics is related to paradoxical reaction, characterized by increased~     talkativeness, emotional release, excitement, and excessive movement. In recent years,~     propofol has been used safety and effectively in sedative GI endoscopy because of its potent~     hypnotic effect and its ultrashort pharmacokinetic profile. Therefore, The present study was~     conducted to compare the safety and efficacy of BPS (propofol in combination with midazolam)~     with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic GI~     endoscopic procedures.~   "
148883|NCT01617694|"~     Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are~     known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The~     investigators will compare the effects of two drugs on prevention of cough during emergence~     from general sevoflurane anaesthesia.~   "
148884|NCT01617681|"~     To assess efficacy, safety and tolerability of valsartan when comparing two doses of~     valsartan in reducing and controlling blood pressure in children with hypertension with or~     without CKD.~   "
148885|NCT01617668|"~     To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in~     women with triple negative breast cancer whose tumors are positive for a defined pattern of~     gene expression~   "
148886|NCT01617655|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels~     after 24 weeks of treatment in comparison with placebo.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time~          points~        -  To evaluate the effects of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
148887|NCT01617642|"~     Acute intermittent porphyria (AIP) is an autosomal dominant inherited disease, which is~     relatively prevalent in northern Norway with a total of around 90 patients. This provides us~     with a special opportunity to study AIP. AIP is caused by a mutation in the porphobilinogen~     deaminase, an enzyme in the haem synthesis. AIP presents symptoms, particularly among fertile~     women and older men. Typical symptoms are abdominal pain and dark red urine, nausea,~     vomiting, constipation, muscle weakness and nerve damage including paraesthesia and even~     paresis. This is known as symptomatic or manifest AIP (MAIP). Others do not display symptoms,~     so-called latent AIP (LAIP). AIP attacks may be triggered by a host of medicaments which~     affect the haem synthesis, infections, alcohol and stress. Treatments of manifestations~     include high sugar intake (4 sugar lumps/hour), alternatively administer glucose and~     Normosang (synthetic haem arginate) by intravenous injection and removing triggering factors.~     Diet, glucose intake, dental health and inflammatory parameters will be examined. This study~     can provide new knowledge about why only some people develop symptoms of AIP. Main~     hypothesis: There are differences in the diet, iron status, inflammation and glucose~     metabolism of the MAIP group vs. the LAIP group and the control group.~   "
148888|NCT01617629|"~     The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian~     cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer~     eligible for study participation due to disease progression.~   "
148911|NCT01617330|"~     Proximity to traffic, particularly to diesel-powered heavy-duty vehicles, has been associated~     with inducing and enhancing allergies in children and adults. To investigate the basis for~     this association, a controlled exposure of allergic rhinitics to diesel exhaust was performed~     at a dose known to be pro-inflammatory in healthy individuals.~      The hypothesis was that airway inflammation would be augmented in allergic rhinitics~     following exposure to diesel exhaust at an environmentally pertinent particulate matter~     concentration.~      Fourteen allergic rhinitics were exposed in a double-blinded, randomised trial to both diesel~     exhaust at 100 microgram/m3 PM10 (representing an aerosol of nanoparticulate combustion~     particles, mean diameter 80 nm) and filtered air for two hours on separate occasions.~     Bronchoscopy with endobronchial mucosal biopsies and airway lavage was performed 18 hours~     post-exposure, and samples were analysed for markers of inflammation.~   "
148912|NCT01617317|"~     Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent~     plasma from patients recovered from H1N1 2009 influenza A infection, for patients with severe~     H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the length of~     stay in ICU and hospital.~   "
148889|NCT01617616|"~     Dysautonomia, primarily defined as postural orthostatic tachycardia syndrome (POTS) can~     seriously disrupt a child's daily activities. It is most commonly associated with nausea or~     abdominal pain. In preliminary studies, when orthostatic intolerance was treated with~     fludrocortisone, a standard therapy for orthostatic intolerance (OI), symptomatic improvement~     in nausea was observed. However, children with POTS were also observed to have higher supine~     mean arterial pressure (MAP) (preliminary data) and greater suppression of the baroreceptor~     reflex sensitivity (BRS) occurred upon up-right tilt. While fludrocortisone alleviates nausea~     associated with OI, its long-term use may pose long term health risks to children including~     worsening hypertension. Therefore, it is the objective of this study to define the mechanism~     for OI as it relates to nausea. The investigators hypothesize that OI resulting from changes~     in the autonomic nervous system is the likely mechanism for the nausea observed in the~     patients in this study. The investigators further hypothesize that this is potentially an~     early marker for future cardiovascular problems such as early onset hypertension and cardiac~     hypertrophy. The general objective of this protocol is to address this gap in knowledge by~     determining the autonomic characteristics of children with OI as well as defining~     neurohumoral profiles for these subjects to better understand the cause of the elevated~     supine in these subjects. By better understanding the potential mechanism for this condition,~     it is the investigators future goal to develop a more focused and safer treatment strategy.~     The investigators will study subjects between 10 to 18 years of age utilizing the tilt table~     to mimic daily life stressors and also measure serum levels of epinephrine, norepinephrine,~     rennin, angiotensin II, aldosterone, and vasopressin at baseline and during tilt. This study~     will generate data with high impact in that more rational treatments for management of~     dysautonomia could be chosen on the basis of the profile of dysautonomia and neurohumoral~     markers.~   "
148890|NCT01617603|"~     Type 2 diabetes is being acknowledged as a potential public health time bomb, whose incidence~     is predicted to double over the next 10 years in the UK, associated with the rise in obesity~     and increasing sedentary lifestyles. Increased insulin resistance has been shown to be an~     important feature of type 2 diabetes (especially in those presenting with obesity and in~     particular visceral or abdominal obesity). Insulin resistance is implicated as a risk factor~     of cardiovascular disease and may lead to pancreatic dysfunction through increased β-cell~     stress in the pancreas. A combination of insulin resistance and pancreatic beta cell failure~     then leads to type 2 diabetes. The main cause of morbidity and mortality in type 2 diabetes~     is cardiovascular disease as the condition is associated with impaired vascular functioning~     and increased levels of oxidation markers.~      Epidemiological studies suggest dietary flavonoids decrease the risk of death from coronary~     heart disease, cancer, and stroke. Flavonoid-rich foods include fruits and vegetables as well~     as tea, red wine, and chocolate. In a cohort of elderly men, cocoa intake was inversely~     associated with blood pressure and 15-year cardiovascular and all-cause mortality. It has~     been reported that in healthy humans, consumption of flavanol-rich dark chocolate decreased~     daytime and night time blood pressure, reduced insulin resistance, and improved nitric oxide~     dependent vaso-relaxation. Another trial found that cocoa powder increased postprandial~     insulinaemia in lean young adults. These research papers have led to the hypothesis that~     chocolate containing high cocoa liquor may help to reduce the risk of developing type 2~     diabetes.~      This study is design as a double-blind, controlled, single center, randomized, parallel~     design clinical trial. The primary outcome measure is to compare parameters of insulin~     resistance and glycaemic control in volunteers with type 2 diabetes after consumption of 3~     different chocolates (one dark and two milk chocolates) with a secondary outcome of~     endothelial function, cholesterol profile and oxidative stress. Subjects will undergo medical~     screening, anthropometry, physical activity and dietary assessments before randomization.~   "
148891|NCT01617590|"~     This study was intended to assess the efficacy and safety of different Disease-Modifying~     Antirheumatic Drugs cycle combination regimen using the American College of Rheumatology~     (ACR) criteria of 20% improvement in symptoms (ACR20) in managing active adult rheumatoid~     arthritis.~   "
148892|NCT01617577|"~     Filgrastim (G-CSF) is widely used for treatment of patients who have a deficiency of white~     blood cells. It is also routinely used to stimulate and mobilize stem/progenitor cells for~     bone marrow transplantation. In studies of thousands of healthy donor subjects treated with~     G-CSF, the side-effects profile has been reported to be mild and reversible. Currently, G-CSF~     is under investigation in clinical trials in Germany and the US that aim to enhance recovery~     from strokes and heart attacks. In animal studies, G-CSF has been observed to improve~     cognitive performance and to markedly reduce amyloid deposition in hippocampus and entorhinal~     cortex in a mouse model of Alzheimer's Disease (AD). Since this drug is being used safely in~     many people throughout the world, the investigators hypothesize that it will also be safe to~     give to patients with Alzheimer's disease and that it may improve some aspects of memory and~     thinking. The present pilot study has two goals or objectives: 1) to investigate the effects~     of a five day schedule of Filgrastim administration on cognitive function and 2) to assess~     its tolerability and safety in a small group (12 patients) with mild to moderate stage AD.~     Patients who are eligible for the study will be randomly assigned to one of two groups (n=6~     per group). One group will receive a five-day course of Filgrastim injections and the other~     group of subjects will receive vehicle injections (solution without drug). At the end of the~     first phase of the study (week 8), the groups will cross over to receive either vehicle or~     Filgrastim as appropriate. In this way all subjects will have received the active medication~     by the end of the study. After the study is finished the investigators should know whether or~     not Filgrastim improves some aspects of thinking and memory. And the investigators should~     know whether or not it is safe to give this medication to patients with Alzheimer's disease.~     To ensure that the drug is safe, a Safety Monitoring Committee will oversee the entire study.~     They will review all laboratory data, including complete blood counts, serum chemistry, EKGs~     and adverse events.~   "
148893|NCT01617564|"~     Paracervical blockage can reduce severe pain during second trimester induced medical~     abortion.~   "
148894|NCT01617551|"~     Catheter based renal denervation (CRD) in humans represents a promising new treatment of~     resistant hypertension. CRD is currently investigated as a treatment option in patients with~     resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in~     a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are~     randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which~     CRD reduce blood pressure are only partly understood and the interaction between renal~     sympathetic nerves and nitric oxide (NO) has not been investigated in humans.~      To Study the interaction between NO and renal sympathetic nerves, we designed the present~     substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are~     studied before and after CRD.~   "
148895|NCT01617538|"~     Objective:~      To monitor and evaluate the change of intracranial hemodynamics and MCA stenosis after~     24-week atorvastatin treatment using CEUS, CTA and DSA.~      Study design:~      Total 30 patients (60 arteries) will be enrolled in this study, who had MCA infarction within~     6 months prior to screening, and has not received any statins treatment before stroke.~      Eligible patient will receive atorvastatin 40mg treatment for 24 weeks. Hemodynamics changes~     and MCA stenosis will be evaluated using CEUS at baseline, 3-month,and 6-month. MCA stenosis,~     bloodstream velocity, as well as clinical symptoms will be assessed at each visit and~     compared to baseline.~   "
148896|NCT01617525|"~     The primary aim of this study is to compare, in a group of at-risk individuals, the role of~     three dietary patterns on indices of Cardiovascular Disease (CVD) risk: a) the recommended~     Korean pattern; b) the typical American diet, based on national dietary intake surveys; and~     c) the 2010 DGA diet pattern. A secondary aim will be to assess the effects of each diet on~     intestinal microbiota and on inflammatory biomarkers.~   "
148897|NCT01617512|"~     The purpose of this study is to determine if it is possible to identify activities in the~     daily accelerometer measures of a person with urinary disorders.~   "
148948|NCT01616849|"~     This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this~     study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with~     nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.~   "
148904|NCT01617421|"~     Background:~        -  People with arthritis should be active. Regular exercise leads to less pain, more~          energy, improved sleep, and better day-to-day function. Yet arthritis is one of the most~          common reasons people give for limiting activities.~        -  Yoga for arthritis has been studied before. However, few studies have included~          minorities. Making changes to yoga classes based on language and culture may help people~          use yoga to care for their arthritis symptoms. Researchers want to see if minority~          populations with arthritis will come to and benefit from yoga classes.~      Objectives:~      - To see if yoga classes designed for people with arthritis will be acceptable to minorities~     with arthritis.~      Eligibility:~        -  Adults at least 18 years of age who are enrolled in the Natural History of Rheumatic~          Disease in Minority Communities study.~        -  Participants will have osteoarthritis or rheumatoid arthritis.~        -  Participants will be able to speak and read English or Spanish.~      Design:~        -  The total study period covers 10 weeks.~        -  The first study visit will include an initial questionnaire about health and arthritis.~          Participants will also have a physical exam.~        -  Participants will have yoga classes twice a week for 8 weeks. The classes will be 1 hour~          long each.~        -  After completing the yoga classes, participants will complete another questionnaire~          about their health. They will have a final physical exam.~        -  Follow-up contact will be made 3 months after the end of the study.~   "
148905|NCT01617408|"~     Background:~      - The brain has two systems for recognizing objects. One system recognizes what an object is,~     and the other system recognizes where the object is located. However, there is much about how~     the brain handles and interprets the information from these two systems that is still~     unclear. Researchers want to study the parts of the brain that are involved in how vision is~     processed. They will use magnetic resonance imaging (MRI) and transcranial magnetic~     stimulation (TMS) on the brain. MRI measures what parts of the brain become more active when~     tasks are performed. TMS uses magnetic pulses to temporarily change the activity in parts of~     the brain.~      Objectives:~      - To better understand how people visually recognize different types of objects.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age.~      Design:~        -  This study includes many different experiments on vision. Each experiment may combine~          visual tasks, MRI scans, and TMS. Participants may be asked to have several different~          tests. Each test will require a separate visit to the National Institutes of Health.~        -  Participants will be screened with a physical exam and medical history. They will have a~          baseline brain scan at the first visit.~        -  Participants may do visual tasks alone, with MRI only, with TMS only, or with MRI and~          TMS combined. For the visual tasks, they will look at pictures of objects on a computer~          screen. Sometimes the images will appear very briefly (less than one-tenth of a second).~          Sometimes they will appear for up to 5 seconds. These images will be of things like~          faces, bodies, tools, and scenes. Participants will be asked to respond in different~          ways to the pictures. They may respond by typing on a computer keyboard or by pressing a~          button. Participants will have time to practice the tasks before the experiment.~        -  Participants will remain on the study for up to 3 years.~   "
148906|NCT01617395|"~     Background:~      - Research shows that both genes and the environment influence a person s risk for getting~     multiple sclerosis (MS). However, it is not possible to accurately predict who will develop~     MS. Researchers want to study people with MS and their family members. They have developed a~     Genetic and Environmental Risk Score for MS. This score combines information from a person's~     medical history and genes. It also includes environmental factors that may be related to~     developing MS. This study will test this risk score to see if it can help predict who will~     develop MS.~      Objectives:~      - To evaluate a score for genetic and environmental risk factors that may help predict~     whether a person will develop MS.~      Eligibility:~        -  Individuals at least 18 years of age who have MS.~        -  Individuals between 18 to 50 years of age who are the parent, brother, sister, or child~          of a person with MS.~      Design:~        -  People with MS will allow researchers to look at their personal and medical data. These~          data will have been collected in other MS-related studies.~        -  Relatives of people with MS will fill out a questionnaire and give blood and saliva~          samples. They will fill out the questionnaire again one year later.~        -  Some relatives will have additional optional testing. These tests will include a~          physical exam and imaging studies. There may also be other tests. These tests may be~          repeated every 1 to 5 years for 20 years.~   "
148907|NCT01617382|"~     The purpose of this study is to register the follow-up data of patients who, because of a~     peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC.~   "
148908|NCT01617369|"~     The purpose of this research study is to learn about how long hypertonic saline (HS) works in~     healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic~     Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up~     in the lungs. Hypertonic saline and other medications currently being developed may help~     patients with these lung diseases by speeding up mucus clearance from the lung. For these~     treatments to be effective, they likely need to be able to act for at lease several hours.~     Investigators are able to measure how lung treatments like hypertonic saline work by~     conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how~     long hypertonic saline works in people who do not have CF. Investigators plan to use this~     information to improve the design and testing of new treatments for patients with chronic~     bronchitis.~      Objectives:~        1. The investigators will use MCC measurements to determine the durability of action of~          hypertonic saline in healthy (i.e. non-CF) subjects.~        2. The investigators will determine the intra- and inter-individual variability of baseline~          MCC measurements using a slow inhalation/large particle protocol in healthy subjects to~          guide future sample size calculations.~   "
148909|NCT01617356|"~     Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be~     quite long lasting and debilitating. Dextrose injection with a small needle has be notably~     helpful in preliminary studies in reducing pain and improving jaw function. This randomized~     trial will compare dextrose injection with saline injection for temporomandibular(jaw)~     dysfunction, also known as TMD.~   "
148910|NCT01617343|"~     Spatial neglect represents one of the major cognitive disorders following stroke. Patients~     patients fail to be aware of objects or people to their left and orientate instead to their~     right side. Enduring neglect has been found to be a poor prognostic indicator for functional~     independence following stroke. Despite some promising experimental accounts there are no~     established treatments for this condition.~      The aim of this study is to test whether a combined treatment with hemifield eye patching~     (HEP) and optokinetic stimulation (OKS) can permanently reduce neglect behaviour and improve~     functional outcome in patients with hemispatial neglect following stroke.~      The investigators hypothesise that the treatment with HEP and OKS will lead to a greater~     reduction of neglect scoring in the neglect test battery as well as a greater improvement in~     functional independence scores as compared to the spontaneous clinical course of the~     usual-care control group.~   "
148913|NCT01617304|"~     The aim of the project is to investigate the effects of advanced glycation end products~     (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the~     human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is~     that i) food content of AGEs is lower using boiling and steaming cooking methods and that ii)~     AGEs formation in the body is lower at low dietary intake of certain sugar forms.~   "
148914|NCT01617291|"~     The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the~     pre-hospital setting of a four county emergency medical system (EMS) that serves both urban~     and rural communities improves meaningful survival from medical cardiac arrest.~   "
148915|NCT01617278|"~     The purpose of the study is to assess whether the use of I-scan during colonoscopy leads to~     an increased yield of adenomas in the colon among a population at increased risk for CRC.~      Primary Outcome:~      To estimate the mean number of adenomas per colonoscopy for both high definition white light~     colonoscopy and I-scan enhanced colonoscopy~      Secondary Outcomes:~        1. To estimate the recruitment rate~        2. Number of adenomas detected in the right colon during the second look~   "
148916|NCT01617265|"~     The purpose of the present study is to determine whether administration of sedation according~     to a strategy including a bundle of measures to prevent oversedation is associated with a~     reduction in mortality of intensive care unit patients requiring mechanical ventilation,~     compared to administration of sedation according to usual practices.~   "
148917|NCT01617252|"~     The main objective of this study is to evaluate the gas exchange (ventilation-perfusion~     ratio) with the system Optiflow® compared to facial mask among patients having an acute~     respiratory failure after cardiac surgery.~   "
148918|NCT01617239|"~     The goal of the study is to assess the safety and immune response after vaccination with~     different doses and vaccination schedules of virosomal influenza vaccine.~   "
148919|NCT01617226|"~     This is a multicentre, open-label, randomised phase II trial comparing azacitidine~     monotherapy with combined azacitidine and vorinostat in patients with newly diagnosed,~     relapsed or refractory acute myeloid leukaemia or high risk myelodysplastic syndromes~     ineligible for intensive chemotherapy.~   "
148920|NCT01617213|"~     This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy~     in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2)~     with autologous PBSC transplant.~   "
148921|NCT01617200|"~     Participants who have completed the 6-week trial P05688 can be screened for eligibility for~     this 26-week extension study in which they will continue treatment. The purpose of this trial~     is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice~     daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily~     (QD) is used as an active control.~   "
148922|NCT01617187|"~     The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually~     twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms)~     as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15~     mg orally once daily (QD) was used as an active control. The primary hypothesis is that at~     least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms~     as measured by the change from Baseline in the PANSS total score at Day 42. The first key~     secondary hypothesis is that at least one of the asenapine doses is superior to placebo in~     improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global~     Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is~     that at least one of the asenapine doses is superior to placebo in improving schizophrenia~     symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS~     Total Score) at Day 42.~   "
148923|NCT01617174|"~     The first goal of this study is to learn more about the experience of pain and other symptoms~     in men being treated for advanced prostate cancer. The second goal of the study is to~     identify reliable ways of measuring pain which will be used in future clinical trials of~     treatments for advanced prostate cancer.~   "
148924|NCT01617161|"~     We are studying whether men being treated for prostate cancer have the same amount of side~     effects from either one of two different external radiation treatments: IMRT or PBT. With~     IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another~     type of external radiation treatment for prostate cancer that is used in a few centers in the~     United States. Protons are tiny particles with positive charge that can be controlled to~     travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams~     instead of x-ray beams.~      IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing~     surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and~     are thought to be equally effective at curing prostate cancer. However, both treatments have~     also been shown to cause the potential side effects of radiation, including bowel, urinary~     and erectile problems. It is possible that side effect rates with PBT will be lower, the~     same, or even higher than with IMRT, but this has not been studied well to date. Though both~     of these radiation therapies have been used in the past to treat prostate cancer, there has~     never been a study that compares the effects of these two therapies to see which one has less~     side effects.~      In this research study, we are comparing IMRT to PBT to determine which therapy best~     minimizes the side effects of treatment.~   "
148925|NCT01617148|"~     This study will examine the use of Aflibercept in patients with exudative macular~     degeneration requiring intravitreal injections. Patients will be followed for 12 months.~   "
148926|NCT01617135|"~     The purpose of this study is to determine the safety, efficacy and pharmacokinetics following~     administration of CVT-301 in treatment of off episodes in Parkinson's Disease patients.~   "
148927|NCT01617122|"~     This protocol is designed to ascertain whether the bacteriophage 0X174 neoantigen is safe and~     effective as an antigen used in the evaluation of primary and secondary immune responses.~     Bacteriophage 0X174 is given intravenously 2 billion PFU/Kg of body weight; small blood~     specimens of 3-5 ml (about 1 teaspoon) are collected after 15 minutes, 7 days, 14 days, and~     28 days. Blood is collected at intervals following the administration of the bacteriophage~     and the number of phage/ml is determined by the agar overlay method using suspension of E.~     coli C and serially diluted patient's serum. Phage-specific IgG and IgM are measured by~     neutralization assay. Capacity of switch from IgM to IgG is determined.~   "
148928|NCT01617109|"~     The primary objective of this randomized, double-blind, placebo-controlled trial is to~     determine the effect of vitamin D and calcium supplementation (800IU and 2000mg,~     respectively) on biochemical indicators of nutritional status and bone health in military~     personnel during Army basic combat training (BCT) and Air Force basic military training~     (BMT).~      The investigators hypothesize that daily supplementation with vitamin D and calcium during~     military training will improve vitamin D status, stabilize PTH levels, and result in~     improvements in markers of bone health. As a result of the investigators study design, the~     findings will provide critically important data regarding the concentration of vitamin D in~     blood necessary to stabilize PTH levels and to optimize bone formation during initial~     military training.~   "
148929|NCT01617096|"~     This is a double-blind, randomised, placebo-controlled study to assess the safety and~     efficacy of a silicone elastomer vaginal matrix ring.~   "
148930|NCT01617083|"~     The purpose of this research study is to know if the antibiotic azithromycin, an antibiotic~     approved by the U.S. Food and Drug Administration (FDA) for treating infections, improves~     symptom severity in children with sudden and severe onset obsessive compulsive symptoms known~     as PANS, Pediatric Acute Onset Neuropsychiatric Syndrome, and PANDAS, Pediatric Autoimmune~     Neuropsychiatric Disorder Associated with Streptococcus. This study seeks to compare the~     effects of placebo vs. azithromycin on Obsessive Compulsive Disorder (OCD) symptom severity~     as well as to assess immune risk factors in children with PANDAS/PANS. Obsessions are~     repetitive, unwanted thoughts or worries that may be unpleasant, silly, or embarrassing.~     Compulsions are repetitive or ritualistic actions that are performed to ease anxiety or~     worries. Doctors think these symptoms may be caused or exacerbated by certain infections such~     as Streptococcus pyogenes, Mycoplasma pneumonia, Borrelia burgordfi, etc. These infections~     commonly cause strep throat, walking pneumonia, and Lyme Disease, among others.~      This study will involve a 4 week double-blind, placebo-controlled randomized trial of~     azithromycin (Double Blind Phase). At the end of this 4 week trial, the child will be~     assigned to azithromycin for 8 weeks (Open Label Phase). At the end of these 12 weeks, a~     Naturalistic Observation phase will assess the child's symptom characteristics for up to 40~     weeks.~      The study hypothesizes that children receiving antibiotic will show significantly greater~     overall improvement in severity compared with placebo, and that children with sudden onset of~     OCD and whose subsequent course shows dramatic fluctuations will have evidence of immune risk~     factors that predisposes to this presentation.~   "
148931|NCT01617070|"~     This study examines the effect of tetrahydrobiopterin (Kuvan) and Large Neutral Amino Acid~     (LNAA) therapy on melatonin and dopamine levels in individuals with Phenylketonuria (PKU).~     The investigators hypothesize that Kuvan therapy will improve melatonin secretion and urine~     dopamine levels to some extent. However significantly greater responses in melatonin and~     dopamine secretions may be observed with combined treatment with Kuvan and supplementation of~     LNAA.~   "
148932|NCT01617057|"~     The aim of this study is to assess the efficacy of a biphosphonate (tiludronic acid, Skelid®,~     Sanofi-Aventis) in the treatment of inner ear involvement in advanced otosclerosis~   "
148933|NCT01617044|"~     A double-blind randomized controlled trial comparing iron plus vitamin C plus probiotic~     (lactobacillus plantarum 299) to iron plus vitamin C plus placebo in correcting the iron~     deficiency in children with Restless leg syndrome (RLS) and iron deficiency. One hundred~     children with diagnosis of RLS will be recruited over a two- year period.~   "
148934|NCT01617031|"~     The aim of the study is to evaluate platelet function variations according to the delay since~     last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous~     Coronary Artery Disease.~   "
148935|NCT01617018|"~     PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients~     receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous~     psoriasis. It is resulting from the merging of two studies that share the same study~     population but address different objectives: PSOBIO, developed by academic dermatologists and~     epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU~     MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on~     safety issues, and Pso-TEQ, developed by industrials at the request of the French~     Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.~      The overall general objective of PSOBIO is to assess in real life the safety and efficacy~     of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional~     systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use~     of biological therapies in real life and long-term benefit.~   "
148936|NCT01617005|"~     This observational study will evaluate the safety and efficacy of tocilizumab in participants~     with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data~     will be collected from each eligible participant initiating tocilizumab treatment over 6~     months.~   "
148937|NCT01616992|"~     Interstitial cystitis/painful bladder syndrome (IC/PBS) causes severe bladder pain and~     extensive disability in a large group of women int he prime of their productive lives.~     Extensive study of the bladder itself has uncovered many abnormalities, but the investigators~     do not know if these are the cause or result of the disorder. None of these has led to any~     real long-term progress in treatment, so far. The investigators have found that other~     autonomic disorders often occur in both the patients themselves and in the family members of~     patients with IC/PBS. The investigators therefore propose to determine whether the main~     abnormality in IC/PBS actually lies in the autonomic nervous system, rather than the bladder.~     The investigators will do this through careful measurements of autonomic function and~     sensation in patients who have IC/PBS, both at rest, and under controlled psychological~     stress. The investigators will compare their measurements to patients with myofascial pelvic~     pain, to know which abnormalities are truly linked to IC/PBS, and which simply reflect the~     presence of pelvic pain.~   "
148962|NCT01616654|"~     To assess the efficacy and safety of different concentrations of CD5789 cream in subjects~     with acne vulgaris for the purpose of dose identification.~   "
149036|NCT01615692|"~     The purpose of this study is to evaluate leg health for one additional year in patients with~     symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic~     Syndrome (PTS) during the 2 years of follow up in the SOX Trial.~   "
162059|NCT01444638|"~     Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not~     have pre-spinal ultrasound examination of their back.~   "
148938|NCT01616979|"~     During cardiac displacement for off-pump coronary artery bypass(OPCAB) surgery, the presence~     of air underneath the displaced heart compromises the transgastric (TG) window for~     transoesophageal echocardiography(TOE). The investigators hypothesised that placing a~     saline-filled glove would enhance TG transmission of ultrasound and facilitate TOE imaging~     for monitoring left-ventricular regional wall motion (LV-RWM). For left circumflex coronary~     artery (LCX) grafting in OPCAB surgery (n=13), mid-oesophageal (ME) and TG TOE images are~     recorded before cardiac displacement (T control), after displacing and stabilising the heart~     (T-displaced), and after placing a saline bag (saline-filled surgical glove) underneath the~     displaced heart (T-saline bag). Following data are determined by integrated TG and ME TOE~     views (ME+TG) at T-control, T-displaced and T-saline bag: number of readable segments (NRS)~     in a 17-segment model; NRSs in basal and mid-TG short axis views; NRS in 5-LV segments of the~     LCX territory; the incidence of inadequate monitoring of LV-RWM (NRS < 14/16 except for the~     apex in 17-segment model).~   "
148939|NCT01616966|"~     Vocal cord injuries occur not only during tracheal intubation, but also during surgery and~     during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle~     relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less~     vocal cord injuries than a total intravenous anesthesia with propofol.~   "
148940|NCT01616953|"~     The purpose of this research is to determine if a patient's own bone marrow tissue can help~     regenerate bone in the area of the jaw where an implant will be placed. The name of the~     process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be~     collected and sent to a laboratory where it will be processed to form more cells. These new~     cells will then be transplanted in the regenerative site. The researchers are testing to see~     if these cells (BRC) will help form bone. The research will also determine if the implant~     will be more stable in the area with new bone growth.~   "
148941|NCT01616940|"~     The purpose of this study is to determine whether an enhanced peer intervention is effective~     in retaining and re-engaging at-risk people of color living with HIV/AIDS into care.~   "
148942|NCT01616927|"~     Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive cyst~     formation in both kidneys, in most patients leading to end stage renal disease. It is the~     most common hereditary renal disease with a prevalence of approximately 1 in 1,000 persons.~     The majority of patients also have progressive cyst formation in the liver, leading to pain,~     gastrointestinal discomfort and sometimes the need for liver transplantation. At present~     there is no proven therapeutic intervention to slow the rate of disease progression in human~     ADPKD. The development of renoprotective treatments that are well tolerated, is therefore of~     major importance.~      In this respect, somatostatin analogues are promising for especially polycystic liver~     disease, but also for the renal phenotype. However, the studies that have been performed thus~     far with these agents, were underpowered and of too short duration to reach a definitive~     conclusion on the potential reno- and hepatoprotective efficacy of somatostatin analogues.~     Therefore, the present study is designed as a randomised clinical trial with sufficient~     duration of follow-up to investigate whether the somatostatin analogue Lanreotide slows~     progression of polycystic kidney and liver disease in ADPKD-patients.~      To this end, 300 ADPKD patients, aged 18-60years, with an eGFR 30-60 ml/min/1.73 m2) will be~     randomized 1:1 to standard care or monthly subcutaneous lanreotide injections on top off~     standard care. These 300 subjects will go through 15 study visits in 3 years and 1 follow up~     visit. During these visits, questionnaires will be filled in, physical examinations will be~     performed, blood will be drawn and urine collected. After study completion, rate of renal~     function decline in lanreotide treated subjects will be compared to that of subject who~     received standard care.~   "
148943|NCT01616914|"~     Delirium has been associated with clinical outcomes in critical care setting. However, its~     subclinical form has not been investigated. The investigators aimed to establish the~     association of subclinical delirium with outcome.~   "
148944|NCT01616901|"~     The decision to extubate a patient after acute respiratory failure is based on clinical~     observation and measurement of pulmonary mechanics. Current extubation criteria(tidal volume,~     respiratory frequency...) lack of specificity. The best way to evaluate and predict patients~     breathing abilities after extubation is to challenge him to a spontaneous breathing trial~     (SBT) with endotracheal tube in place immediately before extubation to predict the patient's~     ability to breathe spontaneously after extubation. The intention is to approximate, while the~     patient is still intubated, the work of breathing that will be required of the patient after~     extubation. Different approaches of ventilatory settings are currently used for the~     preextubation SBT, whether pressure support ventilation (PSV), continuous positive airway~     pressure (CPAP), or spontaneous ventilation through an endotracheal tube (T piece), all~     supported by literature with different benefits. To the investigators knowledge, few studies~     define which mode of ventilation most closely approximates the work of breathing during~     spontaneous respiration after extubation, and none have studied a specific population of~     obese patient in respiratory weaning. The main objective of the investigators study is to~     determine, between five different SBT, which one is the best to approximate the work of~     breathing of obese patient after extubation.~   "
148945|NCT01616888|"~     The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting~     balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.~   "
148946|NCT01616875|"~     26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4~     cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given~     intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the~     overall response rate and to determine whether this approach warrants further research of a~     phase II/III study.Participation in 2 sub studies will also be offered to the participants.~        1. Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after~          cycle 1 and cycle 3.~        2. A pilot sub study involving the circulating tumour cell concentration from blood samples~          taken at baseline, prior to each cycle of chemotherapy and prior to surgery~   "
148947|NCT01616862|"~     Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung~     infections in people with CF. Many young children do not have Pa in their lungs but will~     become infected as they get older. The investigators want to learn more about how Pa is~     passed from person to person, especially to someone with Cystic Fibrosis (CF).~   "
148949|NCT01616836|"~     The aim of this study is to determine the best method of pain control that will help with~     rehabilitation after total knee arthroplasty (TKA). Currently, the best method for pain~     control after TKA appears to be continuous femoral nerve block (FNB) where a small tube is~     placed beside the nerve that provides sensation to a large part of the knee and local~     anesthetic infused after surgery causing numbness to the surgical site. A single injection~     method also exists and may provide similar benefits. Both methods require training and can~     result in side effects such as temporary weakness (while the local anesthetic is still~     working) that can inhibit rehabilitation. A newer method injecting local anesthetic into the~     joint after surgery (Local Infiltration Analgesia (LIA)) is becoming common, does not cause~     weakness and can be done quickly at the end of surgery. It is unknown if the pain control~     provided by LIA is as good as that of FNB. This study will compare the femoral nerve block,~     continuous femoral nerve block and LIA technique to determine which provides better pain~     relief after TKA.~   "
148950|NCT01616823|"~     In optimally managed HIV+ women with undetectable viral loads, who are on HAART and also~     receiving intrapartum IV ZDV, the risk of vertical transmission of HIV is independent of the~     length of time of rupture of membranes.~   "
148951|NCT01616810|"~     The purpose of this study is to determine the validity of a screening tool which has been~     designed to detect the presence or absence of lower urinary tract symptoms in the general~     female population.~   "
148952|NCT01616797|"~     The research proposes to use an innovative solution to shape brain circuits that support~     executive function and emotion reactivity -using targeted neurobehavioral intervention.~   "
148953|NCT01616784|"~     For type-1 diabetes, the aim of insulin therapy is to keep blood glucose close to normal~     while avoiding hypoglycaemia but this is severely limited by the relative crudeness of~     current insulin delivery in comparison with the physiology of the β-cells which secrete~     insulin. Insulin is generally administered by multiple injections MDI with the dose adjusted~     according to eating and exercise. Insulin can now also be administered using a pump (CSII),~     which is a device, roughly the size of a mobile phone and containing sufficient insulin to~     supply both the needs of basal metabolism throughout the day, and the boluses which have to~     cover meals. The use of CSII is expensive compared to injections, but there are important~     potential benefits which include improved glycaemic control, reduced risk of hypoglycaemia~     (low blood sugar) and a more flexible lifestyle and better quality of life. There have been~     no trials in adults that have compared CSII treatment with MDI where the same structured~     training in intensive insulin therapy has been given, so the precise benefit of the pump~     technology is still unclear. There is a need to establish this, and identify patients who~     benefit the most so that the Department of Health can calculate the proportion of adults that~     would benefit from CSII therapy and so ensure that commissioning bodies provide the necessary~     reimbursement. The aim of the trial is therefore to establish the added benefit of CSII~     therapy over multiple injections on glycaemic control and hypoglycaemia in individuals with~     Type 1 diabetes receiving similar high quality structured training (Dose Adjustment For~     Normal Eating:DAFNE) in insulin therapy. Additional assessments will include effects on~     quality of life and cost effectiveness.~   "
148954|NCT01616771|"~     The investigators evaluated the usefulness of the Glidescope(GVL) compared with direct~     laryngoscopy in patients whose airway management are anticipated difficult (C&L grade ≥3) by~     comparing the laryngoscopic view. Also, the investigators compared the effectiveness of~     smaller-size blade of GVL (GVLs) with standard blade of GVL selected by patient's weight~     (GVLw) in the same patients.~   "
148955|NCT01616758|"~     The primary efficacy analysis will be the clinical benefit at 6 months as measured by a~     modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary~     endpoints of objective response rate, progression free survival, time to progression,~     duration of response, effects on physical function, and effects on tumor progression in women~     with Androgen Receptor positive breast cancer will also be assessed.~   "
148956|NCT01616745|"~     The purpose of this study is to elucidate phenotypic, clinical, and genetic characteristics~     of Korean Nontuberculosis Mycobacteria (NTM) patients.~   "
148957|NCT01616732|"~     The investigators hypothesise that testosterone therapy will synergize with dietary~     intervention to achieve weight loss. Obese men will receive diet, and be randomised to either~     testosterone therapy or placebo. Primary outcomes will be weight and body composition.~   "
148958|NCT01616719|"~     DTRAX Graft is used to relieve nerve pressure in the neck in order to provide relief for~     Cervical Degenerative Disc Disease. This study is being conducted to determine the~     effectiveness of the graft, and to find out whether or not it provides better results or~     faster healing than traditional ways of performing surgery for Cervical Degenerative Disc~     Disease.~   "
148959|NCT01616693|"~     The percentage of participants with a serologic immune response (seroconversion or four-fold~     rise in rotavirus IgA antibodies) to rotavirus vaccine at 14 weeks of age among infants~     receiving zinc or probiotic supplements will be at least 15% higher and significantly better~     to that of infants who receive a placebo for zinc or probiotic supplement.~   "
148960|NCT01616680|"~     The purpose of this research is to test the safety and efficacy of brentuximab vedotin in~     patients with acute skin graft-versus-host disease (GVHD)~   "
148961|NCT01616667|"~     The aim of this study is to investigate the clinical outcome of the two different, but widely~     used, surgical approaches (Posterior approach and Lateral approach) of primary total hip~     arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main~     study and two sub-studies. The main study investigates the patient-reported outcome measures~     (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the~     level of physical function and pain within the first 3 month after surgery, and ii)~     investigate the potential difference the two approaches have on gait-patterns and maximal~     isometric hip-muscle-strength, within the first year after surgery. Both approaches are~     described with potential drawbacks. Posterior approach has a higher risk of dislocation of~     the prostheses and revision due to dislocation compared with Lateral approach. Contrary,~     Lateral approach is described with the potential drawbacks of pain, lower physical function,~     gait abnormalities and muscle weakness, leading to less satisfied patients. However,~     according to a Cochrane analysis from 2004 concludes, more investigation is needed to~     determine the extent of differences.~   "
148963|NCT01616641|"~     Rheumatoid arthritis (RA) can affect any synovial joint. Unlike the hand, ever so valued in~     the physical examination of patients with RA, the joints in the area of the jaw and neck may~     also be affected in this disease and have their involvement usually underdiagnosed. There are~     few studies evaluating the incidence of orofacial alteration in the examination as well as~     the correlation between bite force (BF) and clinical and functional parameters in these~     patients. The aim of our study was to chacacterize the orofacial alterations in RA patients,~     correlate the results of the orofacial evaluation with clinical and disease activity~     parameters, and correlate the bite force with the hand strenght.~   "
148964|NCT01616628|"~     Identifying effective strategies for improving healthier eating for low- income populations~     is both a clinical challenge and a public health priority. Approximately one-fifth of the~     children in the United States are either overweight or obese. Obesity is even more common in~     low- income populations as are other related health conditions such as diabetes, hypertension~     and cardiovascular diseases.~      The consumption of fruits and vegetables is strongly associated with the prevention and~     management of obesity and diabetes and cardiovascular diseases. Overall, only about 38% of~     Americans consume the recommended servings of vegetables and only 23% consume the suggested~     amount of fruit. Close to 20% of low- income households do not purchase fruits and vegetables~     at all.~      The proposed research offers an opportunity to investigate a different approach to incentives~     for healthier eating in a low-income urban population. Specifically, this study will examine~     a rewards-based incentive for fruit and vegetable purchases with rewards based on cumulative~     purchases. Previous studies have shown that incentives may be an effective means of promoting~     behavior change. The proposed study will provide essential data about the impact of targeted~     incentives to promote acquisition of fruits and vegetables by individuals living in~     households with young children. The investigators plan to design a subsequent, larger study~     based on the results of this study. In the proposed study, the investigators will~     specifically contribute to this knowledge by investigating the effects of rewards-based~     incentives that provide delayed reinforcement.~      SPECIFIC AIMS AND STUDY HYPOTHESES~      The goal of this study is to investigate whether incentives to low-income families to~     encourage purchase of healthier foods can be used to help stem the tide of childhood obesity.~     Although this study is a randomized trial, a major function is collecting data to be used in~     the design of a larger randomized controlled trial comparing two different interventions~     using incentives to promote healthier eating in low-income communities. The investigators~     will test a supermarket gift card with rewards based on purchases of fruits and vegetables~     during the intervention periods. The specific objective is to determine whether that~     incentive system—(where the rewards can be used to purchase anything in that supermarket)~     increases healthier food purchasing practices by low-income families. The primary outcomes~     are: number of servings, and percent of total food dollars spent on fruits and vegetables~     (fresh and frozen). The primary hypotheses are:~        1. Households in the intervention group will purchase more fruits and vegetables than~          controls per week, both during: a) each intervention phase as compared to the baseline~          period and b) in the follow up phase compared to the baseline period. (Between group~          comparisons over time of intervention versus control group)~           The secondary hypotheses are:~        2. Households in the intervention group will purchase more fruits and vegetables per week~          both during: a) each intervention phase as compared to the baseline period and b) in the~          follow up phase compared to baseline. (Within group comparisons over time)~   "
148965|NCT01616615|"~     To establish wether a prophylactic intervention from first trimester with low-dose of aspirin~     improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by~     abnormal uterine artery Doppler at first trimester~   "
148966|NCT01616602|"~     For obese patients, a randomized trial aimed at determining whether colonoscopy performance~     and patient comfort is improved if a patient is in the prone position (lay on their abdomen)~     versus the traditional left-sided position.~   "
148967|NCT01616589|"~     The purpose of this research is to determine if saliva samples can be used as an alternate~     sample type to test for fragile X. By using saliva instead of blood, it would be easier for~     patients to have fragile X testing.~   "
148968|NCT01616576|"~     The purpose of this study is to compare a new sound processing strategy to the current sound~     processing strategy.~   "
148969|NCT01616563|"~     The overall objective of the CHANGE initiative is to change the delivery of care in primary~     care clinics to treat disease by reducing reliance on drugs and hospitals through the~     promotion of scientifically validated nutritional concepts and exercise. Specifically, the~     objective is to identify patients from primary care clinics with metabolic syndrome who are~     not morbidly obese and use diet and exercise interventions to reverse the changes, reduce~     reliance on pharmacotherapy and prevent progression to diabetes and cardiovascular disease.~   "
148970|NCT01616550|"~     The purpose of this study is to assess the quality of postoperative pain management in a~     Canadian teaching hospital following thoracic surgery.~      Hypothesis: Postoperative pain management following thoracotomy or thoracoscopy is still~     suboptimal despite the evidence that adequate pain relief improves outcome.~   "
148971|NCT01616537|"~     Background Patient satisfaction with or acceptance of care assessment is increasingly taken~     into account in oncology. Most cancer and other critically-ill patients require a~     totally-implanted Central Venous Catheter (CVC) for their treatment consisting of a reservoir~     connected to a central venous catheter, which may or may not be valved. It is impossible to~     estimate the number of CVC used in oncology. However, some authors claim that, in 2005, over~     7 million CVCs were placed in the United States in both chronic and acute care. Although many~     patients fitted with a CVC are able to undertake activities which are hindered with other~     external vascular access devices, they are often physically or psychologically anxious about~     their device. To our knowledge, no validated questionnaire measuring patient acceptance of~     and satisfaction with their CVC has been reported in the literature. Based on these~     observations, the aim of our study was to develop and to validate a French-language~     questionnaire dubbed QASICC (Questionnaire for Acceptance of and Satisfaction with Implanted~     Central Venous Catheter) assessing patient satisfaction with and acceptance of their CVC.~     QASICC is designed as a multi-dimensional, self-administered questionnaire comprising~     approximately 30 items related to the use, appearance and pros and cons of the device as well~     as quality of life as perceived by patients using one for treatment.~      Objective The purpose of the study is to validate a French-language self-administered~     questionnaire (QASICC) designed to evaluate patients' satisfaction and acceptance concerning~     their totally-implanted central venous catheter: confirmatory validation of questionnaire~     psychometric properties.~      Study Design This is a prospective, multicenter, open study.~      Primary Outcome Measures:~      Questionnaire's 27 items tested on 990 patients to confirm QASICC internal structure:~        -  Items quality~        -  Dimensional structure~        -  Dimensional consistence~        -  Measure accuracy~        -  Measure reliability~        -  Sensitivity to change~   "
148972|NCT01616524|"~     The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon~     Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus~     Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to~     24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin~   "
148973|NCT01616511|"~     The objective of the study is to demonstrate the long-term safety and performance of the ATI~     Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in~     cluster headache subjects.~   "
148974|NCT01616498|"~     This pilot study is designed to determine the relationship between intra-myocellular lipids~     and muscle contractility in fibers from obese and non-obese older adults. Obese participants~     are being recruited for an on-going weight loss intervention study and this application seeks~     approval to recruit and enroll a lean comparison group of non-obese older adults. The primary~     goal of this study is to characterize the contractile properties of single muscle fibers and~     whole muscle in healthy, non-obese individuals under the same recording conditions the~     investigators used for the obese population to begin to determine whether fat infiltration~     accounts for diminished force.~   "
148975|NCT01616485|"~     The objective of this study is to evaluate the hemodynamic response to a sublingual dose of~     glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.~   "
148976|NCT01616472|"~     The study is designed to assess the association between steroid exposure and five potentially~     steroid-related adverse events within a cohort of individuals with systemic lupus~     erythematosus (SLE). Study objectives are to quantify the fraction of the risk of new (i)~     diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular necrosis~     that is attributable to cumulative corticosteroid exposure in SLE patients. The study will~     consist of five matched case-control analyses nested within the Hopkins Lupus Cohort. Cases~     will be incident SLE cases who have developed one of the case outcomes (diabetes,~     hypertension, cataracts, osteoporosis with fracture or vertebral collapse or avascular~     necrosis). Controls will be matched to cases on time since SLE diagnosis. The primary~     exposures to be assessed are cumulative dose of steroid (g) and cumulative duration of~     exposure to steroids. The extent of the risk associated with steroids will be explored~     through modeling of the relationship and through calculation of attributable risks of~     exposure (number of cases associated with the highest exposure quartile of each primary~     exposure).~   "
148977|NCT01616459|"~     The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two~     formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as~     3-dose primary vaccination during the first 6 months of life followed by a booster dose in~     the second year of life. To comply with the routine infant immunisation program, the licensed~     GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants~     with the pneumococcal study vaccines.~   "
148978|NCT01616446|"~     The purpose of this study is to evaluate whether there are differences in the~     pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed disease~     in children.~   "
148979|NCT01616433|"~     Older adults are at high risk for loss of independence because of age-related chronic health~     conditions. Of these chronic conditions, arthritis accounts for the largest proportion of the~     disability in the community. The investigators propose to target older adults who have~     self-reported arthritis or joint pain for dissemination of a disability prevention program.~     The program will be a collaborative effort of the Arthritis Foundation, the investigators~     Prevention Research Center staff and other key partners in the community. The project will~     develop information needed to provide guidance for implementation of the investigators~     intervention by other agencies and organizations. As a major thrust of the investigators CDC~     Prevention Research Center, the investigators have developed a comprehensive program focused~     on preventing disease and disability in older adults: the 10 Keys to Healthy Aging. Each of~     the 10 Keys disseminates proven approaches and current recommendations for prevention in~     older adults, focusing on age 65+ but also addressing age 50-65 years. The overall objective~     is to determine if an integrated evidence based exercise intervention (AFEP) combined with~     health education on preventive practices for older adults (10 Keys) is more effective for~     improving mobility and risk factors for mobility disability and use of preventive services~     compared to exercise alone (AFEP). The investigators will also propose to evaluate the impact~     of geographic location on outcomes and overall sustainability of the program.~   "
148980|NCT01616420|"~     The main purpose of this implementation science study is to find out if providing aPS at 18~     different Ministry of Health (MOH) VCT clinics in Kenya works and is cost-effective. This~     would enable co-investigators in the Kenyan MOH to justify funding to scale-up these~     services.~      The primary aim of the study is to find out whether providing aPS to sexual partners of newly~     tested HIV-infected individuals can result in more sexual partners getting counseled and HIV~     tested and linked to HIV care programs for initiation of ART if appropriate. The~     investigators hypothesize that aPS will increase rates of case-finding, linkages to care, and~     ART initiation and will not result in social harm.~      The second aim is whether aPS is cost-effective in the Kenyan setting. The investigators will~     estimate how much it costs (when compared to standard methods) to identify and link~     HIV-infected persons into care. The investigators will also determine how successful aPS is~     at preventing future HIV transmission events and other outcomes associated with untreated HIV~     infection. The investigators hypothesize that HIV prevalence among partners in the immediate~     aPS arm will be high enough to make this approach cost-effective from the payer and societal~     perspective.~      Finally, with the Kenya MOH, the investigators want to establish a nationwide monitoring~     system to evaluate why Kenyans are testing for HIV. In the future, when aPS is rolled out~     nationally, this will help Kenyan public health officials define the contribution of aPS to~     HIV case-finding. The investigators hypothesize that the proportion of newly tested~     HIV-infected individuals who report testing because of known exposure to a person with HIV~     will represent a significant proportion of new cases and the investigators will be able to~     identify places in Kenya where aPS will have the greatest impact on HIV treatment and~     prevention.~   "
148981|NCT01616407|"~     The purpose of this study is to assess and compare the effects of a single dose of~     3,4-methylenedioxymethamphetamine (MDMA)and methylphenidate (MPH) on emotional and social~     cognition in healthy subjects. The investigators hypothesize that MDMA enhances affective~     perception for positive and impairs perception for negative emotional stimuli compared to~     placebo or MPH.~   "
148982|NCT01616394|"~     The aim of the study is to evaluate the value of postoperative troponin in the prediction of~     mid term and long term mortality and morbidity in children with congenital heart disease~     undergoing cardiac surgery.~   "
148983|NCT01616381|"~     This protocol describes a 2-arm randomised controlled pilot study assessing the tolerance,~     safety and efficacy of sildenafil compared to control. The hypothesis is that sildenafil will~     be well tolerated and efficacious in patients with chronic heart failure (NYHA class II and~     III) with evidence of systolic dysfunction (EF ≤40 %) and secondary pulmonary hypertension~     (SPAP >40mmHg).~      Patients that satisfy the inclusion criteria will be randomized to sildenafil (40mg x 3) or~     placebo therapy for 6 months in a 2:1 blinded fashion. The placebo group will be compared to~     the active therapy group and analysed for differences in the main study end-points Patient~     Global Assessment and 6-Minute Walk Test.~      The study will also assess safety, tolerability, symptoms and quality of life.~   "
148984|NCT01616368|"~     The investigators propose to study the effect of mindfulness training on the eating behaviors~     and dietary intake of overweight or obese persons. Mindfulness skills training involves~     bringing non-judgmental attention to thoughts, emotions and bodily sensations - including~     hunger and satiety cues. It is hypothesized that as subjects advance through the 8-week class~     series, developing their capacity for mindfulness and in effect learn to pay attention to the~     sensations, assumptions, cognitions, and beliefs that underlie their eating behaviors, that~     their eating behaviors will improve. Specifically, the investigators hypothesize that 1)~     there will be significant improvements in the areas of uncontrolled and emotional eating, 2)~     there will be significant decreases in total caloric intake and significant increases in~     fruits and vegetables, and 3) there will be a positive significant relationship between the~     frequency/consistency of mindfulness practice and improvements from baseline to follow-up~     measures.~   "
148987|NCT01616329|"~     Alloantibodies can lead to serious clinical consequences and logistic problems like obtaining~     properly and timely matched blood for the patients who do develop these antibodies.~     Prevention of such serious events is possible by extended matching and typing of donor's~     blood against the patient's for all the possible antigens, but this process is cumbersome and~     costly. Identifying a high risk group will be a feasible first target for advanced matching a~     big step forward, and the aim of the investigators study. The aim of the project is to~     examine the association between clinical, environmental and genetic characteristics of the~     recipient of erythrocyte transfusions and the risk or resistance to immunization against~     erythrocyte alloantigens that he/she was exposed to during that transfusion episode.~   "
148988|NCT01616316|"~     Subfascial approach method in thyroidectomy maybe result in better quality of life than~     conventional approach method in thyroid disease patients~   "
148989|NCT01616303|"~     This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of~     oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when~     combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy~     (carboplatin and paclitaxel) alone in female patients with advanced ovarian cancer. This~     study is to confirm previous results that showed oregovomab was able to help the body to~     produce an immune response to CA125 (a target that has been identified on ovarian cancer~     cells) in patients with stage III-IV ovarian cancer when they were receiving chemotherapy for~     their disease. The primary aim of the study is to see how well these patients with advanced~     ovarian cancer make an immune response to CA125 by using a specific test (enzyme-linked~     immunospot (ELISPOT) assay) of the patient's blood. The study will also look at the side~     effects of the oregovomab, other immune response parameters, how well the patients respond to~     the treatment of their disease (how long it takes to show that their disease has progressed~     and how long these patients survive overall).~   "
148990|NCT01616290|"~     The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the~     adventitia of arteries following successful angioplasty (PTA).~   "
148991|NCT01616277|"~     The purpose of this study is to determine if the study drug, PF-06252616 is safe and well~     tolerated when given to adult healthy volunteers.~   "
148992|NCT01616264|"~     Thus, the aim of this study was to evaluate the reproducibility of the Computed Tomograph~     scan three-dimensional reconstruction method for the measurement of the TB pleural effusion~     volume in clinically stable patients.~   "
148993|NCT01616251|"~     Background:~        -  New Nordic diet guidelines advocate a reduction in consumption of protein from animal~          sources such as beef and pork, due to environmental concerns.~        -  Instead, intake of protein from vegetable sources such as legumes and pulses should be~          increased.~        -  A previous study showed that a meal enriched with vegetable protein increased the~          subjective sensation of satiety and decreased hunger and ad libitum energy intake (EI)~          compared to animal protein.~        -  This study did, however, not document that vegetable protein per se is more satiating~          than animal protein as the vegetable meal had higher fiber content. Fiber is a likely~          confounder.~        -  The protein from egg is sparingly investigated in relation to appetite. Few studies have~          found that eggs have a high satiety index but further investigation is needed.~      Objective:~      - To examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and~     ad libitum energy intake) compared to isocaloric meals enriched with either red meat or egg~     with similar distribution of macronutrients and content of dietary fibers.~      Design:~      Single-blind randomized 4-way crossover meal study~      Subjects:~      33 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2). Expected completers: n=30.~      End points:~        1. Subjective appetite (VAS) (every 30 min for 3 hours)~        2. Ad libitum EI (3 hours after lunch test meal)~   "
148994|NCT01616238|"~     The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to~     carry out a prospective, non randomised multi-arm study (including a choice of regimen~     intensity) to investigate the safety, tolerability and feasibility of a standardised therapy~     protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic~     standard of care upon which trials of novel therapies will be based in future. The design of~     the study will enable collection of a comprehensive dataset regarding the clinical outcome,~     Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously~     completely uncharacterised population, thus providing the essential platform for designing~     future randomised advanced phase studies in which new therapeutic approaches and novel~     therapies can be prospectively investigated.~   "
148995|NCT01616225|"~     This study (the Adjuvant Growth Hormone Study) is being done to see the effects of adding~     Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF).~     Growth Hormone is a protein that your body normally produces. Growth Hormone can act on~     several different organs, including the ovaries, where eggs are made. From evidence gathered~     from studies done by fertility doctors over the years, researchers believe that women who~     have not become pregnant through IVF in the past might have better results if they go on a~     course of Growth Hormone during the IVF treatment. However, more research needs to be done to~     confirm whether adding Growth Hormone is beneficial and also to find out the best time to~     start Growth Hormone treatment during IVF.~      We hope that our Adjuvant Growth Hormone study will help answer these questions.~   "
148996|NCT01616212|"~     The purpose of this study is to evaluate two brief, sustainable interventions for a sample of~     280 adolescents charged with an initial drug-related offense: Motivational Enhancement~     Therapy (MET) intervention for youth and the Parenting Wisely (PW) intervention for parents.~     Families are assessed for adolescent substance use, HIV-risk, recidivist substance-related~     offenses, treatment entry, and other areas of individual and family functioning.~      It is expected that the combined MET+PW interventions will be more effective than a~     treatment-as-usual intervention (drug education group) for adolescents with parents not~     participating in PW.~   "
148997|NCT01616199|"~     The purpose of the phase 1 portion of the study is to determine the maximally tolerated dose~     (MTD) or recommended dose (RD) and the safety/tolerability of PX-866 in combination~     vemurafenib in patients with any advanced BRAF-mutant cancer.~      The purpose of the phase 2 portion of the study is to compare progression free survival~     (PFS), antitumor activity (response rate), disease control rate (DCR), and the safety and~     tolerability of PX-866 in combination with vemurafenib vs. vemurafenib alone in patients with~     advanced BRAF-mutant melanoma at the doses recommended from Phase 1.~   "
148998|NCT01616186|"~     This is a phase II trial that follows the completion of the phase I UCSF trial of everolimus~     and sorafenib for Renal Cell Carcinoma (RCC). This trial will be for patients who have not~     had treatment for RCC before. This trial will have 2/3 patients getting everolimus/sorafenib~     treatment and 1/3 getting sunitinib, an FDA approved RCC drug. All three drugs are approved~     for advanced RCC when used individually, the combination of everolimus and sorafenib for RCC~     is not approved by the FDA.~   "
148999|NCT01616173|"~     Patients scheduled to have foot and ankle surgery will typically receive a single shot~     sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal~     post-operative analgesic plan. The investigators are investigating the use of perineural~     dexamethasone together with local anesthetics can improve the quality of recovery for~     patients receiving sciatic nerve blocks for foot and ankle surgery.~   "
149000|NCT01616160|"~     Aim 1: To assess steroid sensitivity to mometasone furoate (MF) in cultured nasal polyp~     explant tissue in vitro.~      Aim 2: To assess steroid sensitivity in vivo in each subject by comparing symptom scores,~     nasal endoscopic findings before and following 4 weeks of treatment with mometasone furoate~     nasal spray (MFNS) and by comparing tissue immunohistology in NP biopsies pre- and~     post-treatment withA MFNS.~      Aim 3: To characterize the molecular signature of gene mRNA expression in steroid-sensitive~     and steroid-resistant NP using microarray on NP tissue pre- and post-MFNS treatment.~      Hypothesis 1: Genes that regulate apoptosis are dysregulated in nasal polyp (NP) inflammatory~     cells, epithelial cells and smooth muscle actin myofibroblasts leading to persistence of~     inflammatory cell infiltration and abnormal epithelial and myofibroblast cellular~     proliferation. These can be corrected by mometasone. Apoptosis-regulating genes that cannot~     be corrected by mometasone are upregulated in steroid-resistant NP.~      Elucidation of this dysregulation may prove insightful in understanding the mechanism of~     action of mometasone in NP and identifying potential molecular targets that will increase~     steroid sensitivity or, conversely, overcome steroid resistance.~      Hypothesis 2: There is a molecular signature of gene expression in NP that signifies steroid~     sensitive NP (SS-NP). This signature is altered in steroid resistant NP (SR-NP).~      Elucidation of differences in the molecular signature of SS-NP versus SR-NP before and after~     treatment with mometasone furoate (MFNS) will provide novel insight into treatment of NP with~     steroids.~   "
149001|NCT01616147|"~     This randomized, controlled trial is proposed to study the effect, in a cohort of racially~     and ethnically diverse group of overweight and obese pregnant women, of an Intensive~     Lifestyle Intervention (ILI) which utilize cognitive behavioral strategies to help~     participants achieve and maintain changes in dietary intake and physical activity habits~     compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers'~     post-delivery weight retention. The hypothesis is that the percent body fat at birth will be~     significantly less in offspring from ILI mothers than UC mothers.~   "
149002|NCT01616134|"~     Korean red ginseng (KRG) is popular worldwide since it is believed to contain ingredients~     with a variety of health enhancement effects. Several in vitro studies and animal studies~     showed that ginseng has anti-obesity, anti-diabetic and anti-metabolic disease effects.~     Several studies involving type 2 diabetes mellitus (T2DM) patients reported that~     administration of KRG for 12 weeks resulted in positive effects on the maintenance of sugar~     control effect and improvement of insulin resistance Although there is evidence to suggest~     that KRG could efficacious reduction in postprandial glycemia, the benefits of long-term KRG~     in healthy individuals on insulin sensitivity has not yet been established. Therefore, we~     investigated whether KRG affected insulin sensitivity in healthy overweight or obese Korean~     subjects without overt diabetes.~   "
149003|NCT01616121|"~     It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will~     develop acute heart failure during their hospitalization. Currently, the investigators have~     no reliable parameter for prediction of evolving acute heart failure in such a group of~     patients. As a result, the investigators have no way of preventing acute heart failure.~     Treatment of these patients only begins after appearance of clinical signs of acute heart~     failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of~     evolving acute heart failure. This study will attempt to address whether preemptive lung~     impedance-guided therapy may prevent the development of overt acute heart failure and improve~     their clinical outcome.~   "
149004|NCT01616108|"~     This study seeks to determine if bupivacaine injection of eye muscles can make them stronger~     and stiffer, and thereby correct the position of eyes that are turned in or mis-aligned, a~     condition generally termed strabismus. It seeks further to find out the different effects of~     various concentrations or formulations of bupivacaine, and whether addition of Botox to other~     eye muscles can add to the effect of bupivacaine and enhance the correction of strabismus.~   "
149005|NCT01616095|"~     This study is designed as a follow up study to that performed in 2005.~      In the Baseline study (2005) extensive clinical whole body metabolic phenotyping was combined~     with in depth molecular and cellular biology analyses aimed at investigating the adipose~     tissue morphology as well as metabolic and inflammatory phenotypes in the adult GHD patients.~     Results published in (Ukropec et al., 2008)~      In this study identical endpoints will be investigated with the same methodology and within~     the same population; in order to seek relevant answers to questions on how the 6-yrs of rhGH~     therapy affects the~        -  whole body insulin sensitivity~        -  energy expenditure~        -  body fat distribution~        -  hepatic and skeletal muscle lipid content;~      as well as how it influences the adipose tissue~        -  endocrine,~        -  metabolic &~        -  inflammatory phenotypes.~      The strength of the planned study lies in the extensive whole body and adipose tissue~     phenotyping before and after the 6-year rhGH replacement therapy, that allows to determine~     the long-term effects of rhGH replacement therapy in GHD adults.~      Envisaged weakness is the limited size of the population; GHD adults (n=20); controls [age~     BMI and gender matched] (n=20). This, however, reflects [is limited by] the complexity of the~     study protocol as well as the stringency of the inclusion criteria.~      The clinical data obtained by methods of - integrated physiology would provide an excellent~     interpretation background for molecular-genetic studies at the tissue (adipose tissue) and~     cellular (adipocytes) level. Integration of the two could bring a new quality in the~     investigators understanding of metabolic derangements present in GHD, and will allow~     extending the investigators knowledge on the mechanisms of the long-term rhGH-therapy-induced~     improvement on body composition, metabolic health and the cardiovascular risk.~   "
149006|NCT01616082|"~     The purpose of this study is to better understand the different ways our bodies burn fat~     which may be important for obesity, diabetes, and cardiovascular disease.~   "
149007|NCT01616069|"~     This is a double blind randomization study, assessing hemodynamic response in patients who~     underwent a cardiopulmonary bypass graft (CABG) with cardiopulmonary bypass (CPB) using~     intraoperative trasnesophageal echocardiography (TEE) to know what inotropic drug will be~     batter to improve the heart function. Epinephrine, milrinone, dobutamine and levosimendan~     will be assessment.~   "
149009|NCT01616043|"~     The healing of full thickness skin defects treated with a split thickness skin graft (STSG)~     is frequently associated with excessive scarring and contraction. The psychological burden of~     poor cosmesis of these scarred regions as well as functional problems due to skin tightness~     and decreased joint mobility cause a very significant morbidity in these patients.~     Application of a dermal substitute underneath the split skin may improve the quality of the~     scar. Glyaderm is a dermal substitute derived from human skin and due to the elastin in this~     substitute it will contribute to a long term improvement of pliability and function and a~     better esthetic outcome.~      The main objective is to evaluate the difference in scar quality, after skin restoration of~     full thickness defects treated with Glyaderm® and STSG versus STSG alone. Secondary~     objectives are: to evaluate the percentage of Glyaderm® take before application of~     autografts, to compare healing time and percentage of autograft survival and bacterial load~     in full thickness defects treated with Glyaderm® and STSG versus STSG alone, and to conduct a~     concurrent cost-effectiveness and health related quality of life study (i.e. cost utility~     analysis).~      The study is an interventional, prospective, randomized and controlled interactive web based,~     study in a multicentre setting. Patients with full thickness burn wounds or full thickness~     skin defects will be evaluated before enrolment. A total of 120 patients will be included.~      All included patients will undergo full thickness removal of the burned skin or adequate~     debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol~     preserved allografts for wound bed preparation. At the second operation, 5-7 days after the~     first operation, the allografts are removed. If the wound bed is not suitable for grafting,~     additional wound bed preparation with allografts is required until the wound bed is~     satisfactory. If the wound bed is suitable for grafting, the patient is randomized to the~     Glyaderm® group or the control group. The wounds of the patients randomized to the Glyaderm®~     group are covered with Glyaderm®. After 6-8 days the wounds are finally covered with a thin~     STSG. In the control group, the wounds are immediately covered with a thin STSG.~      Up to one year after complete wound closure, patients are followed-up for scar evaluation and~     quality of life.~   "
149010|NCT01616030|"~     Patients treated surgically for a hip fracture have a need of rehabilitation for the regain~     of former functional skills. Despite an optimized fast track in-hospital rehabilitation~     program it has been found that patients with hip fracture within 2 weeks after the hip~     fracture loose more than half of their muscle strength in the fractured limb compared to~     non-fractured limb. New studies including patients with total hip arthroplasty and strength~     training applied early after surgery has shown promising results regarding prevention of loss~     of muscle strength. No similar study has been found including patients with hip fracture.~      The purpose of this study is to examine the feasibility of progressive knee-extension~     strength training of the hip fractured limb, starting Day 1 after surgical treatment for a~     hip fracture and proceeded every weekday during their hospital stay.~      The study will include 20 patients surgically treated for a cervical hip fracture and 20~     patients surgically treated for an intertrochanteric or subtrochanteric fracture. All~     patients are admitted from their own home. Age 60 years or older.~   "
149011|NCT01616017|"~     Cardiac output (CO) is an important hemodynamic variable in the management of critically ill~     patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential~     complications and there is increasing interest in less invasive methods of measuring CO. This~     study is designed to compare CO values from PAC thermodilution (COTD) and ultrasound dilution~     (COUD).~   "
149012|NCT01616004|"~     The purpose of this study is to determine whether N2O (laughing gas) has an antinociceptive~     effects in healthy volunteers.~   "
149013|NCT01615991|"~     Radiation synovectomy by intra-articular injection of beta-emitting radionuclides is~     considered a reliable and easy-to-perform therapy without harmful side-effects for the~     treatment of inflammatory joint disease in many countries.~      The goal of this study is to demonstrate Yttrium-90 citrate colloid or Rhenium-186 sulfide~     synovectomy are appropriate therapeutic interventions in patients with persistent active~     synovitis of a joint (characterized by pain, tenderness, and effusion) which is resistant to~     systemic therapy and intra-articular corticosteroid injections.~      The primary objective will be to assess the safety of an intra-articular administration of~     Yttrium-90 citrate colloid or Rhenium-186 sulfide.~      The secondary objective will be to assess the efficacy on synovitis.~   "
149014|NCT01615978|"~     This trial is conducted in Japan. The aim of this trial is to assess the safety after~     multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2~     diabetes.~   "
149015|NCT01615965|"~     The purpose of this study is to set up a model for detecting micrometastases in Lymph nodes~     of patients with prostate cancer by quantitative polymerase chain reaction and its impact on~     progression-free survival.~   "
149016|NCT01615952|"~     Blockade of the brachial plexus using a supraclavicular approach provides excellent~     anesthesia for upper extremity surgery. The most serious complication specific to this block~     is pneumothorax. Subsequent modifications of this block including the use of ultrasound have~     lowered the risk from 6% to <1%. Case reports remain and authors have described certain~     factors and strategies to reduce this risk. Most texts and journals describe the patient in a~     supine or semi-sitting position during the block. At the investigators institution the~     investigators perform the block in a semi-sitting position to facilitate needle tip~     visibility with ultrasound. The investigators plan to obtain ultrasound anatomic measurements~     in three different positions (supine, semi-sitting, sitting) using patients consented for~     supraclavicular nerve blocks.~   "
149017|NCT01615939|"~     The purpose of this study is to compare the incidence of postoperative symptoms of neurologic~     injury after a single shot infragluteal-parabiceps sciatic nerve block versus a continuous~     infragluteal-parabiceps sciatic nerve catheter.~   "
149018|NCT01615926|"~     Acute heart failure (AHF) is defined as a gradual or rapid change in heart failure (HF) signs~     and symptoms, such as shortness of breath (also called dyspnea or breathlessness), leg~     swelling, fatigue, breathlessness with exertion, trouble sleeping flat at night, and weight~     gain resulting in a need for urgent therapy. AHF results in over 1 million hospitalizations~     every year, resulting in an enormous public health burden. Approximately 1/3rd of patients~     will either be re-hospitalized or die within three months, and the resultant financial costs~     are large. As such, improving outcomes for AHF patients is critically important. Shortness of~     breath is the most common reason why patients with AHF present to the ER. As such,~     understanding how severe this symptom is, how much it improves with current treatments is~     very important to both patients and physicians. The purpose of this study is to determine the~     degree to which your shortness of breath improves during the first few days of~     hospitalization and its association with how fast you are breathing.~   "
149019|NCT01615913|"~     This study is to explore the optimization of anti‐onychomycosis patch with various~     formulation contents (three patch groups: 3%, 6% and 8% of terbinafine (contains 3‐mg, 6‐mg~     and 8‐mg/patch terbinafine, respectively) combined with fixed 2% ketoconazole (contains 2‐mg~     ketoconazole/patch) and its safety profile.~   "
149020|NCT01615900|"~     The main objective of this study is to optimize the coverage of renal transplant patients~     thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney~     Transplant Failure Score), associated with teleconsultations.~   "
149021|NCT01615887|"~     Amphetamines have been shown to improve cognition but its use is limited due to its side~     effects. Lisdexamfetamine is an amphetamine pro-drug, minimizing these effects and has been~     safely used in children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The~     investigators hypothesize that lisdexamfetamine may improve cognitive abilities in MS~     patients with documented cognitive dysfunction. Because lisdexamfetamine is a stimulant its~     positive effects should be observed primarily in the domains of processing speed and working~     memory. The investigators therefore propose a study in which the primary objective will be to~     assess the efficacy of lisdexamfetamine in improving attention and processing speed in MS.~     The secondary objectives will be (a) the assessment of the safety and tolerability of~     lisdexamfetamine in the MS population, and (b) to test for effects of the drug on other~     cognitive domains, depression, and self and informant reports of cognitive and executive~     function demanding activities and behaviors.~   "
149022|NCT01615874|"~     The purpose of this study is to assess the effect of one of five possible study medications~     used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years~     with persistent asthma.~   "
149023|NCT01615861|"~     The objective of this study is to evaluate clinical outcomes following sub-2 mm~     micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is~     evaluated in two Phases~        -  V4 (6M) endpoint: primary analysis~        -  V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis~   "
149024|NCT01615848|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine~     syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The~     elevated insulin characteristic of PCOS is likely to play a major role in its symptoms.~     restricted calorie High protein diet and mediterranean diet may improve insulin sensitivity~     and therefore lower androgen production in women with pcos women.the purpose of this study is~     to determine which diet is more effective in improving metabolic and reproductive outcomes.~   "
149025|NCT01615835|"~     Use of the EnSite NavX system to map the coronary vasculature during CRT implant~   "
149026|NCT01615822|"~     OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the~     advantage of a longer elimination half-life so is being developed to be administered together~     with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated~     malaria. The study findings will be used to inform the dose and design of future studies. The~     aim of the study is to establish the safety, tolerability and pharmacokinetics of~     co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy~     volunteers.~   "
149027|NCT01615809|"~     The trial evaluates the overall tolerability of the drug and the efficacy of aerosolised~     amphotericin B as a lipid complex (ABLC) for primary prophylaxis of invasive pulmonary~     aspergillosis (IPA) in pediatric patients with acute leukemia undergoing intensive~     chemotherapy.~   "
149028|NCT01615796|"~     GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of~     antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive~     pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative~     pathogens associated with respiratory tract, skin and soft tissue infections including~     isolates resistant to existing classes of antimicrobials.~   "
149029|NCT01615783|"~     Reports suggest that the Medicaid population includes a higher percentage of smokers than the~     general population. A high prevalence of smokers in a population is likely to lead to a~     higher burden of chronic obstructive pulmonary disease (COPD). Few studies have evaluated the~     economic burden of COPD in a Medicaid population. The objective of this observational,~     retrospective cohort study is to estimate the economic burden of COPD in subjects with a COPD~     diagnosis who are enrolled in Medicaid and are receiving maintenance treatment covered by~     Medicaid.~      Specifically, the null hypothesis for the primary outcome measure is that no difference is~     observed in all-cause costs between subjects with and without COPD. The test hypothesis is~     that there is a difference in all-cause costs between subjects with and without COPD.~      Secondary outcomes to be evaluated include all-cause resource use and COPD-related costs for~     the COPD cohort.~      The study uses a medical and pharmacy administrative claims database called MarketScan~     Medicaid Database that contains the medical, surgical, and prescription drug experience of~     nearly 7 million Medicaid recipients. This analysis will use data from 8 states.~   "
149030|NCT01615770|"~     Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment~     strategy in promoting longer-term smoking abstinence. The investigators will also conduct~     secondary analyses of mediators and moderators of treatment response.~   "
149031|NCT01615757|"~     The study will be conducted in the Department of Medical Oncology and Department of~     Haematology , AIIMS, Delhi. A total of 180 patients of Acute Myeloid Leukemia who are in~     complete remission after induction chemotherapy will be enrolled into the study and will be~     further randomized to the two study arms . ARM- A will receive Ara-c at 18 gm /m2 for 3~     cycles and ARM -B will receive Ara-c at 12 gm/m2 for 3 cycles according to the study~     protocol. Aim of the study will be to compare the efficacy of the two doses in terms of the~     relapse free survival and overall survival as well as time to relapse and toxicity /treatment~     related morbidity.~   "
149032|NCT01615744|"~     Between 1994-98 5 hospitals in Stockholm investigated calcaneal fractures in a randomised~     study.~      82 patients were included and randomized either to non-surgical treatment or surgical~     management with extensile lateral approach and reduction with Internal fixation (ORIF) The~     patients were followed and investigated at fixed intervals 2 weeks, 8 weeks, 3 months and 6~     months for clinical review. At 1 year and 8-12 years (mean 10 years) post-injury.~      Both clinical radiological data were collected and several scores were used. The primary~     outcomes scores used were SF-36 and VAS score.~      The results after 1 year and mean 10 years are presented.~   "
149033|NCT01615731|"~     A common practice for preparation for surgical abortion after 19 weeks gestation is the~     placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The~     investigators aim to study the addition of mifepristone as an adjunct to cervical dilation~     prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of~     painful procedures and time in clinic (or away from work/home) that multiple sets of dilators~     can require. The investigators hypothesize that one set of dilators with mifepristone will~     result in similar procedure times and decreased total time as two sets of dilators.~   "
149038|NCT01615666|"~     The purpose of this study is to use a functional MRI (fMRI) index to compare the brain~     activity of healthy volunteers to that of people with mild cognitive impairment (MCI) and~     Alzheimer's disease. The ultimate goal is to develop an early diagnostic tool for Alzheimer's~     disease.~      The study hypotheses are:~        1. The fMRI index will differentiate between Alzheimer's disease, non-Alzheimer's dementia,~          and healthy volunteers;~        2. The fMRI index will distinguish participants with MCI who convert to Alzheimer's disease~          from those who convert to a non-Alzheimer's dementia and those who remain stable;~        3. MCI participants with a lower fMRI index at baseline who convert will progress to~          Alzheimer's sooner than those with a higher fMRI index, and MCI participants with a~          faster rate of fMRI index decline who convert will have an earlier onset of Alzheimer's~          disease.~   "
149039|NCT01615653|"~     -  Hypothesis:~           - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the~          efficacy of neurolysis and subsequent pain control and survival in patients with~          pancreatic carcinoma.~        -  Rationale:~             -  Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal~               thereby only briefly remaining in contact with neural structures and limiting the~               degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result~               in diminished neurolysis and decrease efficacy.~   "
149040|NCT01615640|"~     The aim of the study is to assess the accuracy of dynamic contrast enhanced and~     diffusion-weighted MR Imaging in evaluating response to chemotherapy in osteosarcoma.~   "
149041|NCT01615627|"~     The investigators will test whether hypotonic (diluted) remodulin solution causes less pain~     than the eutonic (undiluted) solution supplied by the manufacturer.~   "
149042|NCT01615614|"~     The purpose of this study is to explore the pharmacokinetics of different dosing regimens of~     rilpivirine in combination with rifabutin in healthy participants.~   "
149043|NCT01615601|"~     The purpose of this study is to evaluate tolerability of darunavir (PREZISTA) or etravirine~     (INTELENCE) in patients infected with human immunodeficiency virus type 1 (HIV-1) who are~     naïve to these medications and in patients who have experienced tolerability issues on their~     current or prior combination antiretroviral therapy (cART). The tolerability is evaluated by~     switching the patients from their previous or current combination antiretroviral therapy~     (cART) to either darunavir or etravirine.~   "
149044|NCT01615588|"~     Five high methylglyoxal (460-667 mg/kg) Manuka honey samples were selected from different~     geographical locales around the North Island of New Zealand and tested for glycaemic index~     (GI) in 10 healthy volunteers in a single-blinded, randomised study. Participants were fed~     honey containing 25g of available carbohydrate in 200 ml water and the blood glucose~     responses measured (area under the curve; AUC) and compared to that of 25 g of available~     carbohydrate from glucose.~   "
149045|NCT01615575|"~     The aim of the present study was to compare the results of transanal haemorrhoidal~     dearterialisation and stapler haemorrhopidopexy in the treatment of grade III and IV~     haemorrhoids with a long-term follow-up.~   "
149046|NCT01615562|"~     The purpose of this study is to determine if changes in blood vessel health lead to the~     menstrual irregularities that women with PCOS experience. This research study will help~     determine if women with PCOS have early changes in their blood vessels called endothelial~     dysfunction, and if the number of progenitor cells (cells that in a healthy person repair~     blood vessel damage) are related to these blood vessel changes. To do so, we will compare~     ultrasound (soundwave) pictures of a large blood vessel in the arm and the results of blood~     tests between women with PCOS and other healthy women with normal menstrual periods.~   "
149047|NCT01615549|"~     Virtual reality devices are widely accepted tools to familiarize surgical novices with the~     principles of laparoscopy. Free Virtual reality training will be tested against basic~     training and efficacy assessed in a randomized controlled trial of surgical novices.~   "
149048|NCT01615536|"~     The hypothesis of this study is that canine fossa trephination (CFT) improves surgical~     outcomes for patients with a severely diseased maxillary sinus.~   "
149049|NCT01615523|"~     Hd-EEG and MRI measures are used to study the maturation of functional networks in order to~     identify the neural circuits underlying executive and memory processes in children born~     preterm. It will be determined whether children born preterm with executive function deficits~     will have an abnormal connectivity between basal ganglia and cortex due to WM injury.~     Moreover, the development of hd-EEG activity during sleep (coherence and travelling waves)~     and brain maturation of children and adolescents born preterm will be compared with the~     respective measures in healthy controls. This is of eminent importance as it helps to~     understand the nature of executive function and hence, it may help to develop neuroprotective~     strategies to prevent executive function deficits in these infants.~   "
149050|NCT01615510|"~     MOR-NRI like Tapentadol are expected to reduce signs and symptoms of central sensitisation~     besides effectively reducing pain intensity in pain. Human pain surrogate models can serve in~     this proof-of-concept study to further elucidate this assumption.~   "
149051|NCT01615497|"~     The investigators are conducting a randomized clinical trial of our new web-based version of~     the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically~     designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling~     at the Substance Abuse Treatment Unit (SATU). The computer-based training program (CBT4CBT)~     focuses on teaching basic coping skills, presenting examples of effective use of coping~     skills in a number of realistic situations in video form, and providing opportunities for~     patients to practice and review new skills while receiving substance abuse treatment.~   "
149052|NCT01615484|"~     The purpose of this research study is to learn about the safety of transplanting lungs~     obtained from non-heart-beating donors (NHBDs) that have been ventilated (attached to a~     breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion~     solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done~     outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device~     used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and~     ventilation is to learn how well the lungs work, and whether they are likely safe to~     transplant.~   "
150542|NCT01596010|"~     This trial is conducted in Europe. The aim of this trial is to investigate whether a~     reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of~     Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.~   "
149053|NCT01615471|"~     The Lose Now NC research study aims to determine feasibility by delivering a community based~     weight loss program for 4 months in Kannapolis, NC in a large group format compared with~     smaller group format, (recruiting approximately 225 participants from Mecklenburg and~     Cabarrus counties and randomizing them to large or small group in-person sessions coupled~     with an interim internet program) to examine reach and recruitment potential, pilot~     intervention procedures, collect process measures to determine satisfaction, adherence,~     attrition, and estimate weight loss for planning a larger trial.~   "
149054|NCT01615458|"~     This study will determine if a version of the chronic care model for individuals with mood~     disorders can improve patient health.~   "
149055|NCT01615445|"~     Previous animal studies have found that resveratrol supplementation significantly increased~     aerobic capacity. The investigators conducted a randomized placebo-controlled cross-over~     study to assess whether resveratrol could provide similar benefits in humans.~      All participants were assigned to two 4-week treatment periods, with a 2 week washout~     in-between. During one period, volunteers in received resveratrol and during the other~     period, they received identical-appearing placebo.~      The primary outcome of interest was change in exercise capacity, as measured by change in~     exercise duration on constant load exercise testing and change in aerobic capacity (peak VO2)~     on incremental exercise testing. Secondary outcomes were tolerability and side-effects~     associated with resveratrol.~   "
149056|NCT01615432|"~     Comparison of the effects of 4 ventilators dedicated to NIV (2 home ventilators and 2~     ventilators designed for NIV) on patient-ventilator synchrony and comfort in patients~     admitted in the intensive care unit for respiratory failure and treated with NIV.~   "
149057|NCT01615419|"~     This multi-center, observational study will evaluate the use in clinical practice and~     efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible~     patients initiated on RoActemra/Actemra treatment according to the approved label will be~     followed for 6 months.~   "
149058|NCT01615406|"~     This is a single arm, open label study of up to 24 prostate cancer patients scheduled for~     prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of~     99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard~     of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND)~     within two weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for~     visible uptake and compared with histopathology.~   "
149059|NCT01615393|"~     This prospective, randomized, single-blind, cross-over study will compare the bioavailability~     of Copegus (ribavirin) administered as tablets and ribavirin administered as capsules in~     healthy volunteers. Volunteers will be randomized to receive a single dose of 400 mg of~     ribavirin either as a capsule or as tablets; after a washout phase volunteers will be~     crossed-over to the other treatment. The anticipated time on study treatment is 10 days.~   "
149060|NCT01615380|"~     Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer~     and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be~     an efficacious treatment component in combating nicotine dependence, especially among women~     for whom concerns about weight gain during smoking cessation are an obstacle to successful~     quitting. In previous trials of women smokers, the investigators program of cognitive~     behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more~     efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to~     Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental~     Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the~     Commit to Quit program is well poised for a larger trial in a community setting where it has~     the potential to reach a large number of female smokers in a setting in which it can be~     sustained. In response to PA-03-126, Behavioral Therapies Development Program, the~     investigators propose a Stage III study in which they will conduct a trial to test the~     investigators CTQ smoking cessation program in the community setting of the local YMCAs. As~     stated in the PA, Stage III research is aimed at understanding if and how an efficacious~     therapy may be transported to the community. The investigators propose a randomized~     controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The~     trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT~     smoking cessation treatment plus contact control. In order to promote transportability to the~     YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is~     similar to the investigators CTQ exercise program, in that it is guided by trained staff and~     requires participants to exercise 3 times per week. If the exercise condition is found to be~     more efficacious than contact control when delivered at the YMCA by YMCA staff, then the~     investigators will be well positioned to partner with the YMCA to pursue widespread, national~     dissemination of this program.~   "
149061|NCT01615367|"~     Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in bipolar~     disorder, yet no empirically validated psychosocial interventions to manage risk factors for~     CVD in BD have been developed. The purpose of this study is to develop and test the~     feasibility of an integrated treatment to decrease CVD risk factors, while exploring whether~     the intervention improves overall functioning and mood symptoms. The designed treatment~     integrates theories on Nutrition strategies, Exercise interventions, and Wellness Treatment~     (NEW Tx) to address risk factors for CVD that co-occur with bipolar disorder. NEW Tx includes~     novel intervention strategies in each of these three modules, as well as modified and~     tailored empirically-supported strategies for bipolar disorder. The primary hypotheses are~     that NEW Tx will be feasible to deliver, acceptable to this population, and associated with~     improvements in CVD risk factors (i.e., waist circumference). Exploratory analyses will~     examine predictors of treatment response and the effect of NEW Tx on mood symptoms and~     overall functioning.~   "
149062|NCT01615354|"~     This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of~     aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy~     volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the~     other period volunteers will receive placebo.~   "
149063|NCT01615341|"~     Chronic allograft injury is the leading cause of graft loss in renal transplantation. The~     shortage of available kidneys for transplantation has reached crisis levels with increasing~     numbers of waiting list mortalities. Strategies to prolong graft survival are urgently~     needed. The pediatric and young adult transplant population is one in which repeat~     transplantation is inevitable and therefore, this group is one who will especially benefit~     from intervention to prolong graft survival. The hypothesis of this proposal is that~     subclinical viral infection is a modifiable risk factor in the pathogenesis of chronic~     allograft injury. The young age of the proposed study population is an ideal one to evaluate~     this objective due to the high prevalence of seronegative recipients. The studies outlined~     will determine the temporal relationship betWeween subclinical viremia, renal allograft~     infection and allograft injury. This will be the first prospective study in renal transplant~     recipients to systematically monitor subclinical viral infection both in peripheral blood and~     in the renal allograft with concurrent quantitative measures of renal function, allograft~     fibrosis, and innate immune activation. The investigators have chosen these 3 outcomes~     because they evaluate a spectrum of renal allograft injury and represent different stages -~     from early to late - in the pathophysiology that leads to renal allograft dysfunction. In~     addition, the role of virus specific T cell immune responses in the control of subclinical~     viral infection and associated allograft injury will be determined. These data are critical~     as they will provide insights into the pathogenesis of injury and will guide development of~     interventions strategies. Importantly, the current treatment strategies for viral disease do~     not prevent subclinical viral infection. Thus, the results of this study may identify that~     prevention, prophylaxis and/or treatment of subclinical viral replication as a long term~     strategy to prevent chronic allograft injury and prolong graft survival.~   "
149064|NCT01615328|"~     Anterior cervical discectomy and fusion (ACDF) has shown good treatment results for a variety~     of cervical spine diseases such as herniated intervertebral disc (HIVD), cervical spondylotic~     radiculopathy (CSR) and cervical spondylotic myelopathy (CSM). ACDF using autogenous iliac~     bone graft is gold standard, however, it may lead to donor-site morbidities. Preventing these~     complications, some authors have tried to use alterative bone graft substitutes. Among these~     alternatives, Cervios ChronOs™ which is the polyetheretherketone (PEEK) cage with~     b-tricalcium phosphate (TCP) has become popular and shown good clinical results. However,~     b-TCP has only osteoconduction ability of three osteogenic properties.~      Recently, Bonion™ which is the PEEK cage filled with hydroxyapatite (HA) / demineralized bone~     matrix (DBM) is introduced. HA/DBM mixture has abilities of osteoconduction and~     osteoinduction, therefore this alternative is expected to show superior bone fusion~     capability to PEEK cage with b-TCP. However, there has been no comparison study between the~     PEEK cage with b-TCP and the PEEK cage with HA/DBM. The purpose of this study is to evaluate~     bone fusion rate between these cervical spine cages using postoperative computed tomography~     (CT)~   "
149065|NCT01615315|"~     Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin~     treatment and hematuria in general population is not well known. The investigators will~     evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy~     large screened populations.~   "
149066|NCT01615302|"~     Rationale:~      Closure of the internal opening is the most accepted standard procedure in the treatment of~     peri-anal fistulas. The mucosal advancement flap is considered as golden standard. In one out~     of the three patients mucosal flap repair fails. Possible causal factors are incomplete~     clearance of pus and debris, incomplete closure of the internal opening, inappropriate host~     response in patients with risk factors like smoking or diabetes. Platelet derived growth~     factors may facilitate closure of the internal opening, especially in patients with impaired~     wound healing.~      Objective:~      The use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal~     advancement flap to achieve a better closure rate of complex peri-anal fistula's.~      Study design:~      Randomized, multicenter trial.~      Study population:~      Patients with complex cryptoglandular peri-anal fistula's.~      Intervention:~      Injection of PRP in the curretted fistula track under the mucosal flap.~      Main study parameters/endpoints:~        -  Recurrence rate~        -  Post-operative pain~        -  Continence~        -  Quality of life.~      Nature and extent of the burden and risks associated with participation, group relatedness:~      Because autologous blood is used, no extra risk are expected.~   "
149067|NCT01615289|"~     Green tea is being recognized as a beverage with potential benefits for human health and on~     cognitive function. In vitro and in vivo studies provide preliminary evidence that green tea~     intake may play a positive role in improving effects on cognitive functions. The~     investigators aim to examine the neural effects of green tea extract on brain activation in~     humans.~   "
149068|NCT01615276|"~     In the present study, the effect of a bolus of intrinsically labeled milk directly after~     one-legged NMES will be studied.~   "
149069|NCT01615263|"~     Lung isolation is frequently used during thoracic surgery. Two techniques are principally~     used: the double lumen tube (DLT) and the bronchial blocker (BB). BB is easy to use but its~     reputation is darken by the need of multiple repositioning during surgery and especially by a~     slower lung collapse than the DLT. Reading recent literature on the subject and according to~     the vast experience of numerous hospital centers, it seems that the slowness of lung collapse~     remains without any solution. This slowness in lung deflation is detrimental to the~     initiation of video-assisted thoracoscopy surgery (VATS) and could be exacerbated in chronic~     obstructive disease (COPD) patients. For this reason, BB use is discredited in numerous~     centers. However, at IUCPQ, the investigators rarely observe slow lung collapse when BB are~     used. For many years, the investigators have used a systematic denitrogenation of the lung~     before the initiation of one lung ventilation (OLV). Furthermore, when the patient is~     positioned in lateral decubitus, the investigators impose an apnea period of about 30 seconds~     to favor collapse of the isolated lung before inflating the cuff. This apnea is always~     limited by the occurrence of oxygen desaturation (≤97%). The investigators also proceed to a~     second period of apnea of 30 seconds associated to a deflated BB's cuff at the pleural~     opening. Subsequently, the investigators inflate the BB's cuff to obtain definitive lung~     isolation. The investigators hypothesis is that the use of two apnea periods, when isolating~     the lung with a BB, will allow the same quality of surgical exposure at 0, 5, 10 and 20~     minutes post opening of the pleura, compared to the one obtained with a DLT. The main~     objective of this study is first to compare the delay between the initiation of OLV and~     complete lung collapse obtained with BB and DLT, in two groups of patients undergoing VATS.~     Secondary objectives are: 1) to evaluate the quality of surgical exposure associated to the~     level of lung collapse, 2) to evaluate the quality of surgical exposure through the video~     camera, 3) to collect surgeons' opinion regarding the device (BB or DLT) that they thought~     was used during surgery. After obtaining institutional review board (IRB) approval, the~     investigators propose a study of 40 patients undergoing an elective VATS at the Institut~     universitaire de cardiologie et pneumologie de Québec (IUCPQ) involving an one lung~     ventilation. They will have to be 18 years old or more, to read, understand and sign an~     informed consent at their pre-operative evaluation. This study will be prospective,~     randomized, and blind to thoracic surgeons.~   "
149070|NCT01615250|"~     This is a randomized study of efficiency and safety of intramyocardial implantation of~     peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with~     myocardial ischemia after preparatory course of shock - wave therapy.~   "
149071|NCT01615237|"~     System level strategies for implementing tobacco use treatment guidelines exist but are~     insufficiently put into practice, particularly in dental care settings. Closing the gap~     between research and practice is stymied by the limited research on systems changes necessary~     to implement tobacco treatment in routine dental care. Drawing from a burgeoning~     dissemination science literature, the proposed study compares the cumulative benefit of the~     following three systems-level strategies: 1) staff training and clinical reminders, 2)~     provider feedback and 3) pay-for- performance (financial incentives), that have been widely~     endorsed by a 2001 Institute of Medicine Report, Crossing the Quality Chasm (IOM 2011) and~     the 2008 PHS Guidelines (Fiore 2007, Fiore 2008, IOM 2011).~      The investigators propose a 3-arm cluster randomized controlled trial that will analyze the~     implementation process and compare the cost and effectiveness of three implementation~     strategies: 1) Staff training and CBP in implementing PHS Guidelines; 2) CBP + provider~     performance feedback (PF) and 3) CBP + PF + Pay-for-performance (provider reimbursement for~     tobacco cessation treatment delivery). Guided by Organizational Change Theory and the Theory~     of Planned Behavior (Ajzen 1991, Damschroder 2009, Greenhalgh 2004, Solberg 2007) the~     investigators will identify multi-level factors that facilitate or impede the implementation~     process in dental clinics. Our primary outcome is improvement in provider delivery of tobacco~     cessation treatment found through extensive meta-analysis (Fiore 2008) to be an essential~     determinant of patient cessation outcomes. Our secondary outcome will be post-intervention~     patient-reported quit rates. In addition to examining the comparative effectiveness of the~     three implementation strategies, the investigators will use a mixed methods approach to~     examine implementation processes (Aim 2) to assess the degree to which the interventions are~     integrated into practice as intended and to clarify the mechanisms through which the~     intervention influences provider behavior.~   "
149151|NCT01614171|"~     Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of~     childhood osteoporosis and congenital blindness for which new treatments are needed. We have~     found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that~     growth hormone therapy will improve muscle mass and bone strength in OPPG.~   "
149072|NCT01615224|"~     Missed abortion is a condition where the fetus has perished but the miscarriage is not~     expelled. Women often present at a routine ultrasound or with a slight brownish discharge.~     Traditionally this condition has been treated with curettage or vacuum aspiration. Lately,~     medical treatment has become more common due to less risk of infection and other~     complications. The routine medical treatment is 800mcg of misoprostol administered vaginally.~     We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal~     misoprostol increases efficacy of the treatment.~   "
149073|NCT01615211|"~     In menstruation an effective shedding of the endometrial lining occurs. Both progesterone and~     estrogen levels fall sharply at this time. During medical abortion the endometrial shedding~     is sometimes ineffective causing an incomplete abortion which may cause prolonged bleeding or~     require surgical intervention. In medical abortion a progesterone antagonist is used as~     treatment but the estrogen levels are not targeted. The investigators wish to explore whether~     addition of letrozole or trilostane which target estrogen levels can lead to a more effective~     shedding of the endometrial lining.~   "
149074|NCT01615198|"~     The purpose of this study is to access the efficacy and safety of LCZ696 compared to~     olmesartan in elderly Asian patients for the treatment of hypertension.~   "
149075|NCT01615185|"~     Background: Surveys have shown that antipsychotic drug combinations are frequently~     prescribed. Amisulpride, an atypical antipsychotic agent, has low incidence of extrapyramidal~     symptom (EPS) but with high cost compared to sulpiride. The objective of the study is to~     compare the efficacy and safety of the 800-mg/d amisulpride and 400-mg/d amisulpride plus~     800-mg sulpiride in the treatment of acute psychotic exacerbations of schizophrenia.~      Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are~     randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800~     mg/d).The hypothesis is that the two treatment groups have the similar efficacy and safety,~     but different cost.~   "
149076|NCT01615172|"~     Comparision of two different cannulation techniques on the neurological outcome in cardiac~     surcical procedures. Study hypothesis: Cannulation of the axilaris artery can reduce~     neurolocical side effects.~   "
149077|NCT01615159|"~     The overall objective of this study is to assist the general public in achieving and~     maintaining the currently recommended sodium intake of 1500 mg/day through a reduced sodium~     intervention that emphasizes spices and herbs. The investigators hypothesize that after four~     weeks of eating a controlled diet, individuals will acclimate and adhere to a reduced sodium~     intake of 1500 mg/day and their taste preferences will change. The investigators also~     hypothesize that individuals in a low sodium behavioral intervention will maintain greater~     adherence to a dietary sodium intake of ≤ 1500 mg/day than individuals in a self-directed~     control group.~   "
149078|NCT01615146|"~     As a result of the underlying disease or its therapy, it is common for patients with blood~     cancers to have low platelet counts. While platelet transfusions may be beneficial in~     preventing or treating bleeding symptoms, in circumstances where the risk of bleeding is low~     they may be unnecessary or even harmful. As a blood product, transfusion of platelets may be~     associated with infectious or allergic complications, and frequent hospital visits for~     transfusion may adversely affect quality of life. Additionally, the potentially overuse of~     platelet products places a burden on health care resources.~      The benefit of the current practice of prophylactic platelet transfusions to prevent~     hemorrhage is unknown. The randomized data that exists is more than 25 years old and not~     informative given methodological limitations and the changing standards of supportive care.~     An alternative, therapeutic, strategy involves only administering platelets to control active~     bleeding.~      The standard of practice in inpatients receiving high dose chemotherapy (either for acute~     leukemia or as part of stem cell transplantation) is prophylactic platelet transfusions. In~     outpatients not receiving high dose chemotherapy, the risk of bleeding is significantly~     lower. No randomized trials have examined the optimal platelet transfusion strategy in~     outpatients with blood cancers undergoing supportive or palliative therapy. Thus the~     potential benefit of prophylactic transfusions in the outpatient setting is unknown.~      The investigators propose to perform a pilot randomized controlled trial to determine if a~     larger trial is possible. The ultimate goal is to determine if a strategy of therapeutic~     platelet transfusions is safe and effective in outpatients with blood cancers and low~     platelet counts.~   "
149079|NCT01615120|"~     Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum~     prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic~     Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with~     luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy.~     This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.~   "
149080|NCT01615107|"~     The paucity of published data concerning the issue of mechanical labor induction in the~     setting of Term PROM has led us to undertake the present clinical trial. This study is~     designed to compare the efficacy and safety of the standard Oxytocin induction protocol with~     the double-balloon catheter device with concurrent oxytocin administration in patients with~     Term PROM and unfavorable cervical conditions.~   "
149081|NCT01615094|"~     The study is designed to find out more about how mood and the nervous system affect the~     body's immune system. The investigators plan to study this in people who have been identified~     by their physician as being at-risk for the development of heart failure. There will be~     approximately 525 individuals participating in this study at UCSD and at the VASDHS.~     Individuals who will be asked to take part in this study will have a functional or structural~     heart problem apparent on an echocardiogram, or a previous heart attack, but no symptoms of~     heart failure. Some individuals will only complete one assessment (consisting of~     psychological questionnaires and interview, walk test, blood draw, and body measurements),~     whereas others deemed high-risk on the basis of a laboratory test, will be asked to~     complete that same assessment every 6 months for the duration of the study.~   "
149165|NCT01613989|"~     Computer assistance in prosthetic hip surgery is able to improve the accuracy of the surgery:~     Associating hip navigation and EOSTM imaging pre-operatively could simplify the procedure of~     hip navigation in lateral decubitus while maintaining the accuracy of the technique~   "
149583|NCT01608529|"~     It has patented a restriction and filtering device ventilatory nasal flow FeelBreathe with~     the aim of increase nasal airflow resistance, therefore the objective was to examine the~     effects of FeelBreathe with lung ventilation and gas exchange during exercise.~   "
149082|NCT01615081|"~     Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with~     other composition and amount of carbohydrates could be of interest in order to decrease the~     glucose and insulin responses after intake of a sweetened beverage/food. Malt extract has a~     sweet flavor but contains a different composition and amount of carbohydrates together with a~     small amount of protein compared to sucrose. Malt extract may therefore be a better~     alternative than sucrose as a sweetener due to a lower increase and more sustained blood~     glucose level. This could be of interest in relation to diabetes and appetite regulation but~     this is yet to be investigated.~      Thus the objective is to investigate the effect of malt extract vs. sucrose on:~        1. 3-hour change in the concentration of glucose and insulin~        2. 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)~        3. Ad libitum energy intake~      Design: 20 men will participate in the 2-way, randomized, double-blind crossover study. The~     test drinks is isocaloric with 75 g carbohydrates Test drinks: malt extract solution and~     sucrose solution (10%) Three-hour subjective appetite ratings and blood samples will be~     assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch~   "
149083|NCT01615068|"~     This multi-center, prospective observational study will evaluate the treatment patterns, and~     the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible~     patients will have an initial metastatic breast cancer diagnosis that has not been previously~     treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis.~     Data will be collected for up to 8 years.~   "
149084|NCT01615055|"~     Many cancer survivors are experiencing problems with memory and other cognitive abilities~     following cancer treatment. Little is known concerning the contributions of potentially~     preventive therapies on cognitive function, but animal studies have pointed to the potential~     value of the medication fluoxetine in this context. We aim to determine whether six months of~     fluoxetine therapy can preserve brain function in patients who have undergone chemotherapy,~     and examine potential biological mechanisms for its protective effects in humans. If use of~     fluoxetine in cancer patients can be validated in this manner, it will represent the first~     drug demonstrated to prevent cerebral dysfunction associated with exposure to chemotherapy.~     Moreover, as this involves an agent that is already FDA-cleared for other indications, widely~     commercially available throughout the U.S. and other parts of the world, and relatively~     inexpensive since it is obtainable in generic formulations, it would represent a~     pharmacologic approach that is amenable to rapid translation to the clinical setting.~   "
149085|NCT01615042|"~     Lenalidomide is a drug that alters the immune system and it may also be directly toxic to~     tumor. Therefore, in theory, it may reduce or prevent the growth of cancer cells or directly~     kill them. We will be studying how lenalidomide can be used to decrease bone marrow blast~     cells in preparation for a bone transplant.~   "
149086|NCT01615029|"~     The purpose of this study is to establish the safety profile of daratumumab when given in~     combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and~     refractory Multiple Myeloma (MM).~   "
149087|NCT01615016|"~     The lungs of infants born too early are extremely underdeveloped. Respiratory Distress~     Syndrome (RDS) is a condition that frequently develops in infants born more than 10 weeks~     early and leads to the collapse of their lungs. Because the lungs had not had enough time to~     mature, they lack a substance, called surfactant that prevents their collapse. To treat this~     problem, physicians apply surfactant to the lungs within the first few hours of life by way~     of the infant's airway using mechanical stimulation (ventilation). Although this treatment~     has significantly decreased the number of infants who die from RDS, the mechanical~     ventilation can cause damage to the tiny lungs that may lead to long term lung disease and~     breathing problems.~      The need for more gentle and less invasive methods of deliver the surfactant to the infant~     has led to the development of two new methods that require little or no mechanical~     ventilation. While both methods are known to work there is no study that has assessed whether~     one method is better than the other or causes fewer complications for the infant. The~     proposed study will determine if it is practical to conduct a clinical trial to compare both~     methods of surfactant administration and to gather preliminary data on which method gives~     better results. Should this study look promising, the resulting data will be used to design a~     larger clinical trial to compare the methods of mechanical ventilation. Results of such a~     trial would help us to understand the best way to administer surfactant to preterm infants~     and thus help doctors to better care for tiny infants at risk of lung disease.~   "
149088|NCT01615003|"~     In this study, typical cases of blood stasis syndrome of coronary heart disease are selected,~     by using microRNA chip, cDNA microarray and other bioinformatics technologies to filter and~     verify related miRNA and its target gene of Coronary Heart disease. Meanwhile, intervene by~     Xuesaitong soft capsules to investigate related miRNA and its target gene of Coronary Heart~     disease.~   "
149089|NCT01614990|"~     The purpose of this study is to evaluate the safety and efficacy of repeated oral~     administration of macimorelin at different doses daily for 1 week for the treatment of cancer~     cachexia.~   "
149090|NCT01614977|"~     Nontuberculous mycobacteriae (NTM) are a group of bacteria that typically cause infections of~     lymph nodes in the neck and face of otherwise healthy children.~      There are currently 3 strategies to manage these infections. Yet, all are not ideal and~     each has downsides.~        1. Surgery: removal of the affected lymph nodes is the most common approach but has the~          disadvantages of potential facial nerve paralysis, the possibility of recurrent~          infection that would require another operation and resolution with a cosmetically~          disturbing scar.~        2. Antibiotics: The antibiotic courses are prolonged and are associated frequently with~          adverse reactions. It is unclear if this treatment has a significant effect on the~          natural resolution process of the infection.~        3. Observation: follow-up the healing process without intervention. However the resolution~          may last a long period of time even more than a year. In almost all cases there will be~          spontaneous discharge of pus from the involved lymph nodes onto the skin that may last a~          few days. Later on a scar will form that may also be disturbing cosmetically.~      The inflammatory response of the body to infections may occasionally be severe. As a matter~     of fact its harmful consequences can be sometimes more serious than those of the bacteria~     that cause the infection. Prednisone and other anti inflammatory drugs have properties that~     could possibly prevent this.~      There is medical experience in using prednisone and similar drugs in addition to antibiotics~     in infectious diseases to decrease the inflammatory response against the infection. One of~     these infections is tuberculosis. The tuberculous bacteria have some common features with the~     nontuberculous mycobacteria. The investigators believe that the inflammatory process in~     infected lymph nodes with nontuberculous mycobacteria is the major cause for the discharge~     from the skin which later leads to the formation of a scar and to the prolonged resolution~     from the infection. Thus in order to hasten the resolution and to avoid formation of a neck~     or facial scar with its cosmetic consequences we suggest the use of prednisone in treating~     nontuberculus mycobacteria lymph nodes infections. Since prednisone depresses the~     inflammatory process as well as the immunity response, we chose to study the effect of~     prednisone combined with antibiotics (as the later will help to overcome the bacteria).~      The purpose of the study is to determine whether the addition of prednisone to antibiotic~     treatment of nontuberculous mycobacteria lymph nodes infections in the neck and face of~     children can hasten the resolution process and improve its cosmetic results.~      The diagnosis of nontuberculous mycobacteria lymph node infection will be based on evidence~     of bacterial growth in culture or on the presence of DNA of the bacteria in pus obtained from~     the involved lymph nodes by fine needle aspiration.~      Generally healthy children with evidence of infection will be offered to participate in the~     study. They will be randomly assigned into the following 2 groups for 8 weeks treatment:~        1. Antibiotics (2 types) and prednisone.~        2. Antibiotics (2 types) and placebo (a material that tastes and look like prednisone but~          does not have any medical effect).~      Prednisone will be given in a dose that will decrease into half twice: after 2 and after four~     weeks.~      Follow-up visits for monitoring the inflammatory process and its resolution as well as~     adverse reactions will be done around 2 weeks, 4 weeks 3 months and 6-8 months after~     beginning therapy,~      Blood tests and chest X-rays will be taken prior to the beginning of treatment. Blood tests~     will be also taken at the first follow-up visit.~      A photo of the face neck and the site of the involved lymph nodes will be taken before~     starting therapy and at each of the follow-up visit.~   "
149091|NCT01614964|"~     This is an initial efficacy study of a candidate antimalarial in human subjects with~     uncomplicated malaria caused by the most common and most important parasite in Africa~     (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P.~     falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug~     (AQ-13) by mouth over 3 days or the current standard treatment, which is 2 doses of Coartem~     twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly~     effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both~     chloroquine-susceptible and chloroquine-resistant parasites. Funding Source - FDA Office of~     Orphan Product Development (OOPD).~   "
149092|NCT01614951|"~     The purpose of this study is to investigate whether patients with a preoperative reduced~     pulmonary function have a better preserved oxygenation capacity after open heart surgery,~     using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with~     standard ECC (Extra Corporal Circulation).~   "
149093|NCT01614938|"~     The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin~     neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly~     cisplatin in locally advanced nasopharyngeal carcinoma.~   "
149098|NCT01614860|"~     Post-discharge mortality and re-hospitalization for acute heart failure (AHF) affects 15% and~     30% of patients respectively, within 90 days. With over 1 million annual hospitalizations and~     a financial cost exceeding 20 billion dollars, AHF is a major public health burden. Yet no~     AHF therapy to date definitively reduces morbidity and mortality, and in stark contrast to~     heart attack patients, highly rated evidence in guidelines do not exist. Although AHF is a~     syndrome and not one disease, typical treatment of patients hospitalized with AHF suggests~     otherwise. Despite substantial differences among AHF patients, therapy is largely uniform;~     patients receive medicine to help get rid of excess volume and little else. Although decades~     of empirical use support the symptomatic benefits of traditional therapies, outcomes remain~     extremely poor. As opposed to the one-size-fits-all‟ approach used unsuccessfully to date in~     clinical trials, identification of specific AHF patient sub-groups is critical, so that~     tailored therapies can be developed and tested. Preliminary data suggests that the~     neurohormone aldosterone may be detrimental in AHF patients. Furthermore, this hormone level~     appears to rise during hospitalization. The investigators therefore propose to identify~     specific AHF patient phenotypes associated with high serum aldosterone levels to subsequently~     address the hypothesis that early aldosterone blockade continued throughout hospitalization~     will decrease re-hospitalization and mortality. Specifically, the investigators hypothesize~     that AHF patients with elevated serum aldosterone levels have a distinct phenotype compared~     to those with lower or normal aldosterone levels. Specifically, they will be older, have a~     lower systolic blood pressure, lower EF, worse renal function, higher BNP, and previous~     hospitalization for HF.~   "
149099|NCT01614847|"~     Background:~      Osmolarity is defined as the concentration of particles dissolved in a solution. Normal tears~     contain various dissolved particles including proteins, salts and other electrolytes. The~     investigators plan to investigate how osmolarity of the tear film changes over time after~     instillation of artificial tears containing hyaluronate. This is one kind of artificial tear~     that is used to treat dry eye.~      Dry eye and tear osmolarity:~      Dry eye is a significant health problem, but diagnosis and treatment are often ambiguous and~     ineffective. There has been a resurgence of interest and research in dry eye in the past 5~     years, and tear osmolarity has emerged as perhaps, one of the most effective ways to evaluate~     tear quality and dry eye status. Dry eye is usually treated with artificial tears, and many~     formulations are available. The investigators will test an isotonic solution that contains~     hyaluronate. Hyaluronate binds water and should help to maintain water on the eye.~      Objective:~      We plan to study the time course of possible changes in tear film osmolarity following~     instillation of an isotonic artificial tear containing hyaluronate. The investigators will~     use the TearLab, a new clinical instrument that has been developed to quickly and easily~     measure tear film osmolarity. Understanding how artificial tears affect tear film osmolarity~     over time can help doctors determine efficacy and dosing schedules. The investigators will~     test the isotonic hyaluronate (Blink Contacts) artificial tears relative to normal saline~     solution.~      Hypothesis:~      The investigators should be able to measure a decrease in tear osmolarity over time following~     instillation due to the water-binding effect of hyaluronate artificial tears relative to a~     control (normal saline solution).~   "
149100|NCT01614834|"~     The aim of this study is to validate a previously developed patient reported outcome~     instrument (in project UCT-D) to assess disease control in chronic urticaria patients~     (Urticaria Control Test - UCT) of age 12 and older.~   "
149101|NCT01614821|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug, PCI-32765, to learn whether PCI-32765 works in~     treating a specific cancer. Investigational means that PCI-32765 is still being studied and~     that research doctors are trying to find out more about it-such as the safest dose to use,~     the side effects it may cause, and if PCI-32765 is effective for treating different types of~     cancer. It also means that the FDA has not yet approved PCI-32765 for use in patients,~     including people with Waldenstrom's Macroglobulinemia.~      PCI-32765 is a newly discovered drug that is being developed as an anti-cancer agent.~     PCI-32765 is a Bruton's tyrosine kinase (Btk) inhibitor drug which interrupts B cell receptor~     (BCR) signaling in lymphomas by selectively and irreversibly binding to the Btk protein,~     which then results in malignant cell death. This drug has been used in laboratory experiments~     and other research studies in B-cell malignancies and information from those other research~     studies suggests that PCI-32765 may be a treatment strategy for B-cell malignancies,~     including Waldenstrom's Macroglobulinemia.~      In this research study, the investigators are testing the safety and efficacy of PCI-32765 as~     a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.~   "
149102|NCT01614808|"~     This research study is looking at biomarkers in urine samples from patients with Wilms tumor.~     Studying samples of urine from patients with cancer in the laboratory may help doctors~     identify and learn more about biomarkers related to cancer. It may also help doctors predict~     how patients will respond to treatment~   "
149103|NCT01614795|"~     This phase II trial studies how well cixutumumab and temsirolimus work in treating patients~     with recurrent or refractory sarcoma. Monoclonal antibodies, such as cixutumumab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.~   "
149104|NCT01614782|"~     The purpose of this study is to assess the multiple rising dose safety/tolerability and~     pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and~     overweight/obese participants with Type 2 diabetes mellitus (T2DM).~   "
149105|NCT01614769|"~     This study aims to assess how glimepiride affects the recovery from hypoglycemia in~     participants with type 2 diabetes mellitus. The primary objective is to estimate the time~     taken by participants to recover from hypoglycemia to euglycemia after treatment with either~     2 mg or 4 mg of glimepiride when compared to placebo.~   "
149106|NCT01614756|"~     The purpose of the study is to determine safety and tolerability of IL-31 mAB~   "
149166|NCT01613976|"~     The purpose of this study is to confirm the safety and tolerability of oral panobinostat~     (PAN) in combination with a fixed dose of 5-Azacitidine (5-Aza) in adult Japanese patients~     with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid~     Leukemia (AML).~   "
149107|NCT01614743|"~     This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy~     and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients~     with rosacea.~      The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the~     cheek area. Upon study entry, subjects will be randomized to receive treatment with~     incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be~     prepared by an unblinded designee and both Physician Investigator (PI) and subject will~     remain blinded for the duration of the study. At the 16 week visit, control subjects will~     enter the rescue arm portion of the study and all study subjects will receive treatment with~     incobotulinumtoxinA to the cheek areas.~   "
149108|NCT01614730|"~     This user evaluation study is to verify that the Modified Neurotech Vital Device does not~     stimulate the pelvic floor muscles compared with the Neurotech Vital Device.~   "
149109|NCT01614717|"~     This investigation is a prospective, randomized, single-blinded and multicenter design.~      The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular~     (BiV) pacing in severely symptomatic hypertrophic obstructive cardiomyopathy (HOCM) patients~     with severe Left Ventricular Outflow Tract (LVOT) obstruction implanted with a Cardiac~     Resynchronization Therapy - Pacing (CRT-P) device.~      Randomization~        -  Implant will be performed (CRT-P).~        -  Patients will be randomized 1:1 to either Treatment Group (Optimized Biventricular (DDD)~          pacing) or Control Group (Back-up Atrial (AAI) pacing) during the first 12 months:~        -  Treatment Group. The patient´s device is programmed to optimized DDD BiV pacing~        -  Control Group. The patient´s device is programmed to back-up pacing AAI.~        -  After 12 months, the patients initially randomized to the Treatment Group (Optimized DDD~          Pacing) will continue in the same group. The patients initially randomized to Control~          Group (AAI Back-up Pacing) will be changed to the Treatment Group (Optimized DDD~          Pacing). And all the patients will be followed 12 months more.~   "
149110|NCT01614704|"~     Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than~     40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have~     improved the prognostic of these patients. They will all most likely to received~     chemotherapy. Despite the fact that chemotherapy has many side effects, these women do~     question the impact of the treatment on their ability to procreate.~      On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when~     medical care potentially affect fertility.~      Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols,~     provide fertility information, and help individualize fertility preservation supports.~      Principal objective is to ensure the absence of ovarian stimulation's side effects and assess~     chemotherapy effects on child carrying potential.~   "
149111|NCT01614691|"~     This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients~     with allergic rhinitis~   "
149112|NCT01614678|"~     The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses~     manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured~     using a semi-automatic process.~   "
149113|NCT01614665|"~     The purpose of this study is to compare how the body absorbs and processes two different~     formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children~     receiving an organ transplant, and how safe and effective they are over a longer period of~     time.~      This study is for children less than 16 years old. No minimum age has been set, however, to~     be included in this study participants must able to swallow the medication capsules intact.~   "
149114|NCT01614652|"~     Treatment of ischemic heart failure.~   "
149115|NCT01614639|"~     We are doing this research study to learn about how acupuncture treatment works. This study~     is being done to look at changes in the brain, NOT to treat pain. We want to learn about~     brain activity during acupuncture. We will look at brain activity when a heating device~     touches the skin of a subject before and after the subject has acupuncture, to see what~     changes.~   "
149116|NCT01614626|"~     The purpose of this study is to assess the longitudinal association between alcohol~     consumption and biomarkers of microbial translocation (sCD14) and inflammation/altered~     coagulation (IL-6/D-dimer); to establish a cohort of HIV-infected Russian drinkers; and to~     establish a sample repository.~   "
149117|NCT01614613|"~     The purpose of this study was to test the performance of an investigational Bayer Blood~     Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal was~     to obtain glucose samples from subjects with diabetes across the meter operating ranges. A~     capillary sample was collected from each subject at 3 different times during the visit to~     obtain natural capillary blood samples with a range of glucose concentrations. Some blood~     samples were glycolyzed to lower the glucose concentration levels and glucose solution was~     added to other samples to raise glucose concentration levels. All meter BG results were~     compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose~     Analyzer). All lancings and testing were performed by study staff.~   "
149118|NCT01614600|"~     The purpose of this study was to evaluate the reduction of contact lens-related dryness~     symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES®~     AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry~     Eye Questionnaire (CLDEQ).~   "
149119|NCT01614587|"~     The objective is to explore the genetic predisposition to early pelvic organ prolapse after~     adequate surgical repair by exploring the association between pelvic organ prolapse~     recurrences and certain polymorphisms.~   "
149132|NCT01614418|"~     Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial~     neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic~     surveillance, there is no other intervention which predictably eradicates pre-cancerous~     gastric lesions.~      Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly~     effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However,~     the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study,~     we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia~     (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated~     with endoscopic RFA. The safety and effects of RFA will be determined.~   "
149167|NCT01613963|"~     This is a study of visual outcomes in retinal disease that seeks to identify the causes of~     visual loss. This data will be used to predict which patients are at risk of losing vision~     and how they can be better treated.~   "
149120|NCT01614574|"~     Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB)~     that leads to progressive accumulation of glucocerebroside within macrophages and subsequent~     tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. The disease~     has been classified into 3 clinical subtypes based on the presence or absence of neurological~     symptoms and severity of neurological disease. Type 1 Gaucher disease affects an estimated~     30,000 persons worldwide and is the most common. Type 1 Gaucher disease does not involve the~     central nervous system. Patients with type 2 Gaucher disease present with acute neurological~     deterioration, which leads to early death. Those with type 3 disease typically display a more~     sub-acute neurological course, with later onset and slower progression.~      The primary objective of this study is to evaluate the safety of every other week dosing of~     velaglucerase alfa in Japanese patients with Gaucher disease.~      Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type~     1 Gaucher disease.~   "
149121|NCT01614561|"~     This was a multicenter survey of patients who were on lipid -lowering pharmacological~     treatment in 2 Levant countries namely Jordan and Lebanon. The purpose is to study the~     effects of cholesterol lowering drugs on the blood cholesterol levels of patients in Jordan~     and Lebanon.~      Data collected from each patient took place at a single visit. Each participating doctor~     filled the investigator questionnaire on his/her experience and perception of the management~     of the hypercholesterolemia of his/her patients. Each doctor was asked to indicate his/her~     general attitude on the diagnosis of hypercholesterolemia, the existing guidelines and goals~     and the various treatment options for high cholesterol in blood.~      Before being assessed by the investigator, patients recorded, on the patient questionnaire,~     their awareness of high blood cholesterol , their current lipid-lowering treatment schedule,~     their understanding of their condition and compliance in taking the medications on time.~      The investigators completed a Patient Record Form (PRF) with the patient's basic information,~     cardiovascular risk factors and the cardiovascular medical history, current lipid lowering~     drug treatment and the reason for the current therapy.~      A blood sample under fasting condition was drawn from each subject. A central laboratory in~     Jordan received all samples. Every sample was analyzed for its cholesterol blood level,~     fasting sugar level and hemoglobin A1C levels.~   "
149122|NCT01614548|"~     Some recent reports indicate that incidence of prostate cancer is increasing rapidly in~     China. However, no large-scale survey of prostate cancer has been done in central China, few~     data are available regarding its management. The investigators aimed to analyze the~     management of prostate cancer and compare the outcome of patients with such a survey.~      The investigators collected data of patients diagnosed with prostate cancer from the 2003 and~     2008 in central China. Data were disaggregated by rural and urban hukou. The survival rate of~     patients was analyzed using Kaplan-Meier method. Prognostic factors were analyzed using the~     log-rank test and Cox proportional hazards model.~   "
149123|NCT01614535|"~     The clinical studies demonstrate more powerful analgesic effect among female to both μ- and~     κ-opioid agonist (Fillingim et al. 2004). The antitussive effect of opioid is mediated~     predominantly by μ-, κ-opioid receptors (Kamei J. 1996). Therefore, the investigators~     hypothesized that there are sex differences in the antitussive responses to opioid.~      It has been reported that target-controlled infusion (TCI) of remifentanil can reduce cough~     against endotracheal tube during emergence from general anesthesia. Some studies, reporting~     the EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence in~     different sex and surgeries (B. Lee et al. 2009, E.M.Choi et al. 2012), showed differences in~     EC50 and EC95.~      The purpose of this study was to find out EC50 and EC95 of remifentanil in effect-site TCI~     for preventing cough during emergence in each sex and to evaluate whether there were sex~     differences in EC50 and EC95 of remifentanil in effect-site TCI or not.~   "
149124|NCT01614522|"~     The purpose of this study is to determine whether ASLAN001 has an effect in patients with~     recurrent or metastatic adenocarcinoma of the stomach, gastrooesophageal junction, or lower~     third of the oesophagus whose tumours over-express HER-1 and HER-2, or whose tumours are~     HER-2 gene-amplified.~      Maximum of 26 patients will participate in South Korea and the patients will be assigned to~     either group A or group B according to the results of tests done on tumor tissue obtained by~     biopsy to determine HER-1 and HER-2 status.~   "
149125|NCT01614509|"~     This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined~     therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the~     treatment of macular edema associated with branch retinal vein occlusion.~   "
149126|NCT01614496|"~     The aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop system,~     using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic~     subjects. Ten subjects will be enrolled and they will participate in a cross-over study with~     a control night, using their usual insulin pump pattern, and with a experimental night, being~     controlled for the closed loop system. Each night includes the overnight control and prandial~     control of the breakfast.~      The system proposes an insulin dose every 5 minutes according with the value of glucose~     displayed by the continuous glucose monitoring system.~   "
149127|NCT01614483|"~     The overall aim of the project is to provide proof-of-principle that biofortification of~     cassava with vitamin A is a viable strategy to improve vitamin A status of deficient~     populations.~   "
149128|NCT01614470|"~     The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects~     with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR)~     gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R,~     G1244E, S1251N, S1255P, or G1349D).~   "
149129|NCT01614457|"~     The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects~     with cystic fibrosis (CF) who have the R117H-CFTR mutation.~   "
149130|NCT01614444|"~     The current study will assess the efficacy of acupressure, a type of complementary and~     alternative medicine (CAM) in the Veteran population. Veterans with co-occurring mild~     traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) will be consented and~     randomly assigned to either an active or placebo acupressure treatment series of 8 sessions.~     The investigators will determine if acupressure affects aspects of day-to-day function, such~     as memory, sleep, mood, psychiatric health and stress resilience. This information will help~     identify potential treatment strategies to improve quality of life and overall function in~     this particular Veteran population.~   "
149133|NCT01614405|"~     Patients with primary biliary cirrhosis (PBC) develop progressive liver disease and often~     require liver transplantation. The cause of disease is unknown. It is thought to occur as a~     result of an infection in subjects that are more susceptible to disease than others. The~     investigators found evidence of retrovirus infection in patients with primary biliary~     cirrhosis. The investigators found that most patients with PBC have evidence of viral~     infection. Since then the investigators have conducted clinical studies using anti-viral~     therapy. The investigators found that PBC patients treated with combination anti-retrovirus~     therapy experienced significant reversal of the disease process. However, the changes were~     not substantial and the investigators are now looking for better antiviral regimens. Now the~     investigators have found a mouse model with a similar virus infection that develops a similar~     biliary disease. Importantly, the investigators found that antiviral therapy blocks the~     development of the disease in this mouse. The investigators have used this model to find~     safer and more effective antiviral treatments for patients with PBC. The investigators have~     now found out that a combination of highly active antiretroviral therapy with Truvada and~     Kaletra stops disease in the mouse and plan to use this combination to see if it works in~     patients with PBC.~   "
149134|NCT01614392|"~     This research study is looking to compare the effects of two uniquely different power~     training interventions (high force, lower velocity versus low force, high velocity) on~     changes in mobility status among older individuals at risk for mobility disability.~   "
149135|NCT01614379|"~     Diabetic foot ulcers often progresses after many years of diabetes where the patients system~     is so damaged that normal heeling of ulcers cannot happen. The physician at the clinic~     examines the foot, measuring its circulation and sensitivity. The measures are the blood~     pressure in comparison between foot and upper arm and oxygen level in the foot. The~     measurements have a direct connection to the blood circulation, but it doesn't visualize the~     blood circulation.~      Development of MR methods without the use of contrast agents have become so good that images~     of the blood veins can be used in treatment. This means that the MR images provide important~     information about the patient vessel wall stiffness and blood circulation without the use of~     the damaging substances. Hence the physician can perform the MR examination and in comparison~     with the test performed at the clinic he can make an improved and without risk diagnose.~     Using MR at a lot earlier stage in the treatment is expected to reduce the number of~     amputations. This is not only an economic advantage, but also an improvement of the patient~     quality of life.~      The objective of the study is to investigate type 1 diabetics oxygen level, vessel wall~     stiffness, blood circulation, tissue contribution and blood pressure in the foot with the use~     of conventional measurements in their treatment and with the added use of MR methods.~      This will provide the physician with valuable information of the patient illness and is~     expected to play an important role in the prevention of diabetic foot ulcers. We expect that~     MR research leads to a much improved prevention and treatment of aggressive and destructive~     diabetic foot ulcers. This will increase the general quality of life and reduce the large~     number of amputations performed every year.~   "
149136|NCT01614366|"~     The purpose of this study is to compare the different dose of DMTA07 (DM) combine with~     amlodipine in the treatment of mild to moderate essential hypertension, and to define the~     optimized dose of DM in the combination therapy.~   "
149137|NCT01614353|"~     Patients can easily be overwhelmed, confused and many times don't fully understand their~     need for new medications, or when the dosages are to be administered (patient research~     partner quote). The long-term goal of this study is to refine medication science by~     developing patient-centered assessment, monitoring and management guidelines for patients and~     health professionals. The objective is to advance knowledge about the medication-taking~     perspectives, experiences, and behaviors of older adults with multiple chronic medical~     conditions (MCMC) to inform future research related to patient-centered medication~     prescribing, monitoring and management. This pilot study addresses the following PCORI~     interest area: evaluating methods that can be used to assess the patient perspective when~     researching behaviors and choices within the patient's control that may influence outcomes.~     The rationale that underlies the proposed study is that medication-taking practices are~     wholly within patients' control, and are foundational to reducing complications and improving~     outcomes for those with MCMC. To meet the overall objective of this application, the~     following specific aims will be pursued: 1) identify perceptions and behaviors surrounding~     the medication-taking process of older adults with MCMC; and 2) generate an interpretation of~     the meaning of medication-taking among older adults with MCMC. To achieve these aims, data~     will be obtained in real time from patients (N=30) receiving a new prescription using smart~     phone technology. The smart phones will include prompts to help participants record thoughts~     about medication use throughout the day for 30 days. Findings from electronic diaries will be~     logged, analyzed and qualitatively analyzed. Some patients (n=15) will provide in-depth~     hermeneutic interviews to provide rich descriptions and interpretive commentary about the~     experience of receiving a new medication prescription. The objective is to uncover previously~     unidentified areas of common experience in older persons with multiple chronic conditions who~     have received a new prescription. Common experiences and patterns of influences, that are~     often surprising or unexpected, will be categorized and assessed. The expected outcomes of~     this pilot study are improved knowledge of medication-taking perceptions, experiences, and~     practices of older adults with MCMC—knowledge that is critical to advance patient-centered~     medication science.~   "
149138|NCT01614340|"~     The overall goal of this real-world comparative effectiveness research (CER) study is to~     reduce disability among older home health patients by treating their pain more effectively.~     To achieve this goal the investigators will conduct a cluster randomized controlled trial of~     a physical therapist (PT) delivered intervention provided to VNSNY home health care patients~     with activity-limiting pain. The intervention is an evidence-based non-pharmacological~     program to reduce pain and pain-related disability that utilizes cognitive-behavioral pain~     self-management (CBPSM) techniques.~   "
149147|NCT01614223|"~     Plantar fasciitis presents clinically as pain in the inner heal, which is the result of~     degeneration of the plantar fascia, an arch supporting ligament of the foot. It manifests~     predominantly in those subjected to sustained weight bearing or repetitive pounding~     activities. Plantar fasciitis is the most common cause of inferior foot pain. Although most~     cases resolving within 6 months, traditional treatment regiments such as orthotics and~     physiotherapy are occasionally unsuccessful in treating this limitation leading to chronic~     symptoms (Neufeld & Cerrato, 2008; Rompe, 2009; Roxas, 2005).~      Platelets are central players in clotting, inflammation and the wound healing response.~     Research has shown the potential of platelet rich plasma to accelerate wound healing in a~     variety of conditions including maxillo-fascial and plastic surgery, chronic wound healing~     and orthopaedics. Autologous Conditioned Plasma (ACP) is a novel treatment that may~     accelerate the healing of injured tissue. Treatment with ACP involves taking a blood sample~     from the patient, isolating the platelets and injecting them back into that patient at the~     injury site~   "
149148|NCT01614210|"~     The purpose of the study is to see if tumors respond to endocrine therapy by taking a total~     of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA~     (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.~   "
149139|NCT01614327|"~     The study is an Observational, Phase 0 designed to establish that the risk for diabetic~     retinopathy assigned by the RiskAnalyzer improves the reading accuracy and consistency of any~     reader and it decreases the inter-reader variability.~      Objectives: Objectives one, two, and three are arranged chronologically and in an increasing~     level of complexity as a three tiered approach to support the primary and secondary endpoint~     of the trial. Objective one is to test fully each system components of the study limited to a~     single site. Objective two is to evaluate the efficacy of the RiskAnalyzer to assign the risk~     of Diabetic Retinopathy in comparison to the gold standard. Objective three is to demonstrate~     that the reader's accuracy in grading images is improved when risk levels assigned by the~     RiskAnalyzer are made available to the reader while performing the grading of the images~     which is the primary endpoint of the trial Methods and Research Design: A network of clinical~     study sites will be established to meet the required number of cases needed as calculated by~     statistical analysis. Male and Female Subjects between the ages of 18-65 who are either~     pre-diabetic or diabetics will be eligible for participation in this study. Subjects will be~     recruited, consented, photographed and their images graded by two trained readers and~     analyzed by the RiskAnalyzer . The risk levels that are obtained from the RiskAnalyzer will~     be compared to the current gold standard practice, manual grading of each case by a reader.~     Data collected during this clinical trial will be reported to the referring physician in the~     form of a retinal screening report completed and signed by a licensed Ophthalmic professional~     and delivered to their attending physician. Risk levels for diabetic retinopathy obtained by~     use of the RiskAnalyzer will not be given to the attending physician under any circumstances~     in order to preserve standard of care for the patient.~      The sensitivity, specificity, receiver operating characteristic (ROC), and data flow process~     of the RiskAnalyzer, retinal image reading system will be analyzed and based on the current~     gold standard of a human reader. This study is a three-aims study, 24 month in length,~     prospective, case-only study of the performance of the RiskAnalyzer. The risk levels obtained~     from the RiskAnalyzer are not made visible, i.e. are not unmasked to either of the two~     readers. In year two, the risk levels obtained from the RiskAnalyzer for half of the studies~     are unmasked to the two readers while grading the image.~      Access to all study data and processes follows a role-based design. The clinical staff will~     have access only to clinical data but not the technical data. The technical team will have~     access to the technical data only but not the clinical data. The study coordinator will have~     access to all data. The use of computers will adhere to the Guidance for Industry~     Computerized Systems Used in Clinical Investigations and applicable sections of 21 CFRs part~     11.~   "
149140|NCT01614314|"~     The purpose of this study was to compare the performance of nursing undergraduates in~     dressing of tunneled central venous access in the simulator, according to the aid of a~     preceptorship or an auto-instructional guide.~   "
149141|NCT01614301|"~     A prospective phase I and consecutive phase II, twoarm, randomized multi-center trial of~     temsirolimus in combination with pioglitazone, etoricoxib and metronomic low-dose~     trofosfamide versus dacarbazine (DTIC) in patients with advanced melanoma~      Phase I: To determine the dose of temsirolimus to be used in phase II part of the study~      Phase II:~      To determine overall survival Secondary objectives~        -  To evalulate response rate~        -  To evaluate time to progression (TTP)~        -  To evalulate time to partial response (time to PR or better)(TPR)~        -  To evaluate quality of life~        -  To evaluate tolerability and safety~   "
149142|NCT01614288|"~     Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a~     knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life~     questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.~   "
149143|NCT01614275|"~     The purpose of this study is to determine the extent to which technology may be used to~     provide (a) state-of-the-art assessment and intervention for children diagnosed with autism~     and (b) parent and tutor training for those who care for these children.~      Children with autism often have problems with social interaction, language, and repetitive~     behavior (e.g., hand flapping and body rocking). Without early and intensive treatments, the~     long-term outcomes for children with autism are not very good; therefore, it is very~     important that effective treatments are started as soon as possible. Research has shown that~     Early Intensive Behavioral Interventions (EIBI) is an effective treatment for autism.~     Although EIBI is effective, most children with autism in military families do not receive~     EIBI because there are few professionals and paraprofessionals that are appropriately trained~     to do this, especially in the remote areas where military families tend to serve. The~     investigators want to show that web-based technologies (e.g., web-cams and internet-protocol~     cameras) can be used so that professionals in one place can treat children with autism~     anywhere in the world. The investigators also expect that providing these services will help~     children with autism improve their language, social, and academic skills. The investigators~     expect that the gains made by the children will help relieve many daily stressors and worries~     that families with children with autism have.~      Children with autism who lack adaptive skills require constant help and supervision from~     parents. Thus, the improvements in the child's functioning will allow the child to become~     more independent and decrease parent stress associated with the need to constantly watch and~     help the child. Because EIBI services produce lasting improvements long after the~     intervention has ended, this project will provide both short-term and long-term benefits to~     the children who participate in the study, which will provide lasting relief to these~     dedicated military families.~      In the long-term, this project may really change the way in which all (military and~     non-military) children and families get effective services that they cannot get now. Also,~     the results may help other professionals and researchers in psychology and medicine. That is,~     the results should be helpful to any kind of service that uses parent training and~     paraprofessionals. Most importantly, these services will improve the overall functioning of~     the children with autism and decrease the overall stress on these families as they continue~     to serve our country.~   "
149144|NCT01614262|"~     Continuous glucose monitoring (CGM) technology has advanced the treatment of people with~     diabetes, however to date this technology had been primarily limited to use in patients~     treated with insulin. CGM is a powerful tool that has the potential to enhance the care of~     patients treated with agents other than insulin; however this has not been tested. The~     purpose of this study is to determine whether improved glycemic control can be achieved~     through the use of intensive, periodic CGM monitoring in patients with T2DM treated with oral~     anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be utilized to~     determine if a larger, clinical effectiveness study to assess use of CGM to improve clinical~     outcomes in patients with T2DM treated with OADs is warranted.~   "
149145|NCT01614249|"~     Fish oil omega-3 supplements provide essential nutrients for brain health and functioning.~     These nutrients have been proven to be effective in reducing depressive symptoms. They have~     also been found to be effective and well tolerated in reducing the bad fat accumulation among~     patients infected with human immunodeficiency virus (HIV)and are using highly active~     antiretroviral treatment. The role of this nutritional supplement in combating depression~     among pregnant women who are living with HIV infection has however not been established. Yet,~     currently, more than 2 million pregnant women are estimated to be living with HIV infection~     globally. In Kenya, about 9.0% of pregnant women are HIV-seropositive.~      In this study, it is hypothesized that there is no difference in the levels of depressive~     symptoms among HIV infected pregnant women who are taking omega-3 fish oil supplements and~     those taking a placebo.~      The study will therefore seek to ascertain that taking omega-3 fish oil nutritional~     supplement has a significant positive effect on depressive symptoms among HIV infected~     pregnant women, compared to a placebo.~   "
149146|NCT01614236|"~     Proper pain relief is a major concern of patients worldwide. Preoperatively, one of the most~     common questions asked by patients pertains to the amount of pain they will experience after~     surgery how long it will last and how good will it be controlled. Pain concerns the surgical~     team as well, because of its correlation with clinical outcomes and patients' satisfaction~     rate . Studies have shown that negative clinical outcome with regard to pain control includes~     decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia, hypertension,~     myocardial ischemia, transition into chronic pain, poor wound healing, and psychological~     sequelae .~   "
149149|NCT01614197|"~     This is a phase I study of temsirolimus (Torisel) combined with dexamethasone,~     cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL),~     lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).~   "
149152|NCT01614158|"~     This present research project intends to collect five quantitative test series:~        -  perimetric examination using static stimuli, assessing the entire (80 degree) visual~          field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/~          magnitude of the visual field defect and its variability within the cohort and over time~        -  D-BCVA, using FrACT [Bach 2007] and EDTRS chart [Ferris 1982]~        -  RAPD (using swinging flashlight test).~        -  IOP (using applanation tonometer)~        -  RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic~          disk morphology will be documented by fundus photography. This assessment of the~          above-mentioned data is needed in order to allow for estimation of the spontaneous~          course / fluctuation of the (quantified) functional and morphometric parameters of the~          N-AION patients during the follow-up period. This is essential for the estimation of the~          sample size of the subsequently intended SINN study, that is intended to compare~          different therapeutic strategies in N-AION patients.~   "
149153|NCT01614145|"~     Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in~     cerebrospinal fluid samples of immunocompromised patients for identification of central~     nervous system aspergillosis.~   "
149154|NCT01614132|"~     The purpose of this study is to determine whether a combination of a radiochemotherapy~     (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in~     adult patients with medulloblastoma is tolerable.~   "
149155|NCT01614119|"~     While the exercise responses are classically described at the cardiorespiratory and muscle~     levels, recent data suggest that the brain is also significantly stressed by exercise and may~     even participate to performance limitation. In hypoxia in particular, cerebral responses to~     exercise may be altered and promote performance reduction during endurance exercise. In the~     present study, the investigators used innovative approaches to assess cerebral perturbations~     associated with exercise in hypoxia.~   "
149156|NCT01614106|"~     This study will evaluate the efficacy of an integrated Retention Clinic in achieving~     virologic suppression among HIV-infected cocaine (including crack) users by using a two-group~     randomized, prospective trial. Eligible participants will be randomized to one of the~     following two groups: 1) Retention Clinic or 2) Treatment as Usual. The intervention~     (Retention Clinic) group will receive up to 11 Patient Navigator sessions over a 6 month~     period and 9 sessions of substance abuse treatment over a 3 month period. Follow-up~     assessments will be conducted at 6 and 12 months post-randomization. Medical records will be~     reviewed to document use of HIV care, drug treatment and mental health services during the~     study period. A total of 360 HIV-infected individuals who report cocaine (including crack)~     use will be randomized across both sites (Miami, FL, and Atlanta, GA). Primary hypothesis is~     that more participants randomized to the Retention Clinic will have undetectable viral load~     than will participants randomized to the treatment as usual group.~   "
149157|NCT01614093|"~     The objective of this study is to test a single dose of intranasal oxytocin, compared to~     placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety~     signaling (behaviorally and/or by self report) compared to placebo. If this single dose pilot~     paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention~     or treatment for weight gain and overeating in people with schizophrenia.~   "
149158|NCT01614080|"~     intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic~     stroke. This effect is due to an early recanalization secondary to the lysis of the clot.~     However this effect may be counterbalanced by the increased risk of bleeding and also the~     neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain~     (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to~     determine whether the functional outcome after treatment by iv rt-PA depends on the ratio~     sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain~     haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).~   "
149159|NCT01614067|"~     In couples with infertility secondary to Diminished Ovarian Reserve, the investigators~     hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist~     (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.~   "
149160|NCT01614054|"~     The purpose of this study is to show that a patient-centered survey asking about smoking~     habits, with the option for nicotine replacement therapy (NRT) will increase the prescription~     rates among health care providers (HCP). The investigators also believe that this~     intervention can also lead to increased referrals to smoking cessation clinics and ultimately~     increase rates of smoking cessation.~   "
149161|NCT01614041|"~     The purpose of this study is to evaluate the efficacy and safety of comparative high dose~     Tandospirone Citrate in the treatment of patients with generalized anxiety disorder.~   "
149162|NCT01614028|"~     This study aims to investigate short-term outcomes following the use of two femoral stems~     used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.~   "
149163|NCT01614015|"~     The proposed effectiveness study examines differences in treatment outcomes of an~     observation-based supervision (BOOST) versus supervision as usual (SAU). The study will be~     implemented within 16 teams delivering FFT services at 11 sites in the California Institute~     of Mental Health (CIMH) system. The 16 FFT therapist teams will be randomly assigned either~     to BOOST or SAU. Each team will have 3 therapists who will treat 6 families for a total of 18~     families per team. Thus, each condition will include 24 therapists who will treat 144~     families. The project will be implemented in four staggered waves to establish a more even~     rate of data collection and treatment implementation to enhance the feasibility of the study~     by keeping staffing and project costs more constant across the 5-year project. Each wave will~     involve 4 FFT teams, 2 receiving BOOST and 2 receiving SAU. Teams will be randomized to~     supervision conditions. Outcome assessments of parents and adolescents will be conducted at~     baseline and at 4 months and 16 months after treatment initiation.~   "
149164|NCT01614002|"~     The main purpose of this observational study with Docetaxel is to determine the number of~     treatment cycles and the quantity of Doce onkovis needed therefore under the special~     circumstance of ambulant chemotherapy.~      onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted~     packaging sizes as to decrease the excess quantity to be discarded follows also this~     objective.~      Secondary objectives are the evaluation of the safety and tolerability of Doce onkovis. To~     this purpose data regarding co medications and adverse events are also collected.~   "
149168|NCT01613950|"~     The study is intended to investigate the safety of BYL719 and AUY922 in patients with~     advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination. In~     addition, the preliminary efficacy of BYL719 in combination with AUY922, and the~     pharmacokinetics of both drugs will be assessed. Patients will be eligible for this study, if~     their tumors carry either a molecular alteration of PIK3CA, or an amplification of HER2.~      The study includes a dose escalation part followed by a safety expansion phase.~   "
149169|NCT01613937|"~     Objective: The current study examined the effectiveness of a culturally-appropriate~     adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes~     risk in Latinas with a history of gestational diabetes mellitus (GDM).~      Research Design and Methods: Seventy-six Latinas aged 18-45 years with GDM in the past 3~     years participated in an 8-week group-based, peer-educator led lifestyle intervention based~     on the DPP, with adaptations appropriate to Latino culture and recent mothers. Clinical and~     self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up~     (month-6).~      Hypothesis-The modified culturally tailored DPP will improve risk factors associated with the~     development of type 2 DM.~   "
149170|NCT01613924|"~     The aim of our study is to determine the time to resolution of individual acne lesions using~     a popular handheld heat based device in comparison to no treatment and to standard topical~     therapy with benzoyl peroxide in order to determine its effectiveness in the spot treatment~     of acne vulgaris. Patient satisfaction and potential side effects will be examined as well.~   "
149171|NCT01613911|"~     This study will help describe how the human brain works when a person sees something, hears~     something, learns something, or thinks about something by recording brain activity that~     occurs when the person does a series of computer tasks. This study will be offered to people~     who are in the hospital to be monitored for epilepsy by using electrodes placed in the brain.~     The study will record brain activity that occurs when a patient does a memory task, for~     example.~   "
149172|NCT01613898|"~     The aim of the proposed study is to evaluate the risk for cardiovascular disease and~     'atherogenic' features of the serum in CTX and to determine preclinical atherosclerosis. The~     study will include an extensive assessment of lipoprotein profile and carotid artery~     intima-media thickness (cIMT) measurement.~      Lipid and lipoprotein profiles will include novel tests such as direct measurements of~     apolipoprotein A1,B,C2,C3 plasma levels, lipoprotein (a) levels, highly sensitive C-reactive~     protein levels and PLAC test that measures the levels of lipoprotein-associated phospholipase~     A2-a vascular-specific inflammatory enzyme implicated in the formation of atherosclerosis~   "
149173|NCT01613885|"~     The purpose of this study is to gain better understanding of how the immune system works in~     twins with and without allergic disease. Healthy volunteers are not specifically targeted.~     Healthy non-allergic study participants may be found through the course of evaluation for the~     presence of allergies.~   "
149174|NCT01613872|"~     This study is studying the effects of Mindfulness Based Stress Reduction (MBSR), a standard~     protocol of gentle yoga and breath meditation, on patients with Traumatic Brain Injury (TBI).~     The investigators are testing whether this intervention can help improve the stress response~     and increase resiliency and mindfulness for patients with TBI, which may lead to improved~     symptoms and neurocognitive function.~   "
149175|NCT01613859|"~     Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is~     an integral part of hemodynamic monitoring of critically ill patients whether it is done~     directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies~     to support the cardiovascular system in critically ill children with multi organ dysfunction.~     Because of the side effects involved in measuring cardiac output directly, intensive~     monitoring of patients is currently limited to an integrated assessment of tissue perfusion,~     oxygen delivery and cellular health both at regional and global levels. Currently available~     methods of measuring CO have their limitations and complications, and are not used routinely~     for bedside monitoring. Therefore, the investigators propose to use a newly developed method,~     termed COstatus for the monitoring of CO in patients admitted to PICU.~   "
149176|NCT01613846|"~     Sorafenib and pazopanib are both effective and promising treatments for advanced Renal Cell~     Carcinoma (RCC). Both drugs are registered for this indication. No prospective comparative~     data in advanced RCC (or other indications) have been published. A search in the~     clinicaltrials.gov database did not reveal any planned or ongoing studies. As sequential~     therapy is now the standard of treatment for advanced RCC it is important to evaluate in~     clinical trials what the value of different sequential strategies is. This needs to be done~     every time new agents are introduced into the treatment armamentarium. As there are no data~     yet on the sequential use of sorafenib followed by pazopanib or vice versa, this sequence,~     however, will most certainly be used in daily practice, it is required to examine efficacy~     and safety of this sequential approach in a clinical trial in a randomized setting.~      Therefore, the investigators have designed an open randomized study in patients not~     previously treated for advanced RCC. Suitable patients will be randomized (1:1) in 2 groups.~   "
149177|NCT01613833|"~     Osteoarthritis (OA) is the irreversible degeneration of articular cartilage and underlying~     bone. It poses a major healthcare problem as it is the leading cause of joint disease and~     disability in the United States. It was traditionally thought that OA was a consequence of~     aging and joint trauma. However, it is now thought that OA is a result of the interplay of~     multiple genetic, biomechanical, and biochemical factors that disrupt the normal homeostasis~     of cartilage, bone, and synovium.~      OA is classified into two groups, primary and secondary. Primary OA is classically~     polyarticular and peripheral while secondary OA can commonly be attributed to a specific~     cause, limited to a singular joint, and a result of trauma. It is known as post-traumatic OA~     (PTOA). Other causes of secondary OA include congenital disorders, calcium pyrophosphate~     dehydrate deposition disease, and other diseases. Regardless of classification, genetic~     variation in the normal metabolism of cartilage and bone is thought to play a role in the~     progression of OA. Furthermore, the polyarticular presentation of primary idiopathic~     osteoarthritis suggests that it may have a stronger genetic component as compared to~     secondary OA, indicating a deviation from normal cartilage and bone homeostasis.~      Matrix metalloproteinases (MMP) and their inhibitors take part in the metabolism of cartilage~     and bone. MMPs are enzymes that catalyze the degradation of elements within joint spaces~     while their inhibitors cease this activity. Alpha-2-Macroglobulin (A2M) is a~     naturally-occurring plasma glycoprotein that functions throughout multiple tissues and~     extracellular spaces as a protease inhibitor but does not normally reach high levels within~     the intra-articular joint space. A2M is believed to modulate the systemic inflammatory~     response by its ability to bait, trap, and clear various MMPs and cytokines. Concentrated A2M~     directly addresses the roles of cytokines and catabolic enzymes known to participate in the~     development of osteoarthritis. Cytonics has shown that A2M can inhibit cartilage degradation~     in vitro. As the role of MMPs and protease inhibitors have emerged as key components of OA,~     the investigation of regulators of MMP has become of interest to elucidate the pathogenesis~     and possible novel treatments of OA.~      This study aims to measure and correlate the levels of alpha-2-Macroglobulin (A2M) in plasma~     and knee joint OA between primary post-traumatic (PTOA) and secondary osteoarthritis groups.~   "
149178|NCT01613820|"~     Ketamine infusions resulted in an acute reduction in global depression scores and in severity~     of suicidal ideation. Scopolamine infusions produced also a significant improvement in~     depression that was sustained over time.~      We therefore plan to investigate the feasibility and efficacy of open-label repeated~     intravenous administration of ketamine and scopolamine combined in this population of~     severely depressed, treatment-resistant patients. The results from this study could lead to~     the development of new strategies for the treatment of patients with TRD.~   "
149179|NCT01613807|"~     Humalog® Mix50/50TM administered as 3 injections daily is equivalent to Humalog® plus Humulin~     N® insulin administered as 6 separate injections daily in terms of glucose control, but may~     have some advantages due to increased ease of use.~   "
149180|NCT01613794|"~     Epidemiological studies have shown a 2-3 fold increased long-term risk of arterial~     cardiovascular disease after venous thrombosis, most predominant in the first year following~     initial venous thrombosis. The results of recent observational studies that showed 40-50%~     risk reductions for first venous thrombosis occurrence when using a statin are in this aspect~     promising. The results are also somewhat surprising, because the mechanism behind this effect~     is unclear. Dyslipidemia may be the most plausible explanation to be considered. However, as~     dyslipidemia is not related to an increased risk of venous thrombosis, it is unlikely that~     statins decrease venous thrombosis risk by lipid lowering activities. Recent observations~     indicate that coagulation can activate the initial formation of atherosclerosis. Our~     hypothesis is therefore that the coagulation profile in persons with venous thrombosis is~     improved when using a statin, ultimately leading to less atherosclerosis: another well known~     property of statin use.~   "
149181|NCT01613781|"~     There have been reports of monitoring LSR during MVD surgery helps predicting the clinical~     outcome of MVD. However, there have been no evidence of which degree of partial neuromuscular~     blockade should be performed during LSR monitoring under sevoflurane anesthesia. Therefore,~     the investigators performed a randomized controlled trial to evaluate the effect of different~     degree of partial neuromuscular blockade on the LSR monitoring for MVD surgery.~   "
149182|NCT01613768|"~     Researchers are doing a research study to examine the use of eribulin (eribulin mesylate) in~     patients with salivary gland cancer. Researchers want to know if eribulin is safe and~     effective in treating salivary gland cancer.~   "
149183|NCT01613755|"~     The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole~     are often used concomitantly in patients with diabetes who have suffered a transient ischemic~     attack or stroke. It has recently been suggested that the gastrointestinal absorption of~     metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has~     been reported to inhibit hENT4 transport in vitro. The aim of this research proposal is to~     study the pharmacokinetic interaction between metformin and dipyridamole. The investigators~     hypothesize that dipyridamole reduces the gastrointestinal absorption of metformin. If this~     hypothesis can be confirmed, then the results of this study can explain in part the high~     variability in plasma metformin concentrations in patients treated with diabetes, and can be~     used to optimize pharmacotherapy in patients with diabetes.~   "
149184|NCT01613729|"~     The primary objective of the study is to compare the efficacy of Rosuvastatin 5 mg once daily~     with Rosuvastatin 10 mg once daily by assessment of the number of patients with~     hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy.~   "
149185|NCT01613716|"~     This study will examine the use of the dexamethasone implant (Ozurdex) in patients with~     macular edema associated with an epiretinal or preretinal membrane requiring surgical~     intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will~     be placed in the eye. Patients will be followed for 1 year.~   "
149186|NCT01613703|"~     The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in~     healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for~     TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the~     plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952~     in healthy subjects.~   "
149187|NCT01613690|"~     The purpose of this study is to see how the body processes and gets rid of NVA237 in people~     who have impaired kidney function compared to people whose kidney function is normal.~   "
149188|NCT01613677|"~     This is a single arm open label phase II trial to evaluate the oral daily use of BKM 120 in~     patients with recurrent unresectable or metastatic cervical cancer after palliative cisplatin~     based regimen failure.~      A complete treatment cycle is defined as a 28 days period.~   "
149189|NCT01613664|"~     Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice~     in the surgical management of patients with morbid obesity. However, this restrictive~     procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage~     (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently~     reliable technique to prevent these complications.~   "
149190|NCT01613651|"~     This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP)~     with pelvic drain placement to see how well it works compared to RALP without pelvic drain~     replacement in reducing adverse events after surgery in patients with prostate cancer.~   "
149207|NCT01613430|"~     The overall goal of the COACH study is to conduct a comparative effectiveness trial to assess~     the effectiveness of trained, participant-designated health coaches versus traditional health~     education efforts on cancer screening among African American older adults. We hypothesize~     that members of older adults' extended families can be trained to be effective coaches who~     support them through the cancer control spectrum, i.e., prevention, screening, diagnosis and~     treatment. This research objective is guided by the theoretical model of the PRECEDE-PROCEED~     conceptual framework that has been widely adopted in health promotion. The target~     jurisdictions for this study are Baltimore City (BC) and Prince George's County (PGC),~     Maryland. The study is anchored in community-based participatory research (CBPR) principles,~     involving community members in all its phases. The CBPR component is guided by Community~     Advisory Groups (CAGs) representing key stakeholders in the two jurisdictions. The CAGs are~     essential in determining the questions included in data collection instruments, mechanisms of~     recruitment, interpretation of findings, and dissemination of results within the target~     communities.~   "
149191|NCT01613638|"~     Congenital malformations rate is about 3% in France. There are already 5 registries in~     France, covering about 16% of French births: Paris Registry, (about 38 000 births /year),~     Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000~     births/year), Auvergne Registry, (about 14 000 births/year), and la Réunion Registry. The aim~     of malformation registries is to carry out epidemiologic surveillance of congenital~     anomalies. The objectives are mainly to provide essential epidemiologic information on~     congenital anomalies, to facilitate the early warning of teratogenic exposures, to act as an~     information and resource centre regarding clusters, to provide data for research related to~     the causes and prevention of congenital anomalies.~      A previous study was carried out in Brittany in 2008-2009, by the perinatal network of Ille~     et Vilaine, in collaboration with two research teams (Inserm U1085 and Inserm U 936), to~     record all cases of 4 types of congenital anomalies: congenital heart disease, spina bifida,~     diaphragmatic hernia and hypospadia. The results showed prevalence rates similar to those~     observed by Eurocat for spina bifida and diaphragmatic hernia, but a higher prevalence~     regarding congenital heart diseases and hypospadia. In this study the investigators could not~     determine whether this was due to a real higher frequency or to a particular exhaustiveness~     in the recording methodology.~      There are hypothesis about the role of intrauterine exposure to pesticides, known as~     endocrine disruptors, and the risk of congenital genital anomalies. Brittany is an intensive~     agricultural area, and it is thus worth studying the impact of pesticides exposure on~     congenital anomalies.~      There are also hypothesis on the impact of occupational exposure to solvents on congenital~     anomalies (Garlantezec 2009), and on the role of alcohol exposure (which concerns about 8%~     pregnant women in France) on oro-facial clefts and congenital heart diseases.~      The Registry of congenital anomalies in Brittany was set up in 2010. The main aim is to study~     the impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of~     congenital malformations diagnosed at births, by measuring the exposure both directly in~     meconium, and indirectly by questionnaires.~      Secondary objectives are to study other risk factors such as medicine intake, pregnancy~     illness…~   "
149192|NCT01613625|"~     Elastography is a emerging imaging technique that has demonstrated high reliability in the~     assessment of tissues stiffness and quantification of fibrosis particularly in adult's~     livers. This ultrasound exploration has no secondary effects. There is no study published in~     the pediatric population concerning the role of ultrasound elastrography in kidney. The aim~     of this study is to look for a correlation between the elastography's results and the kidney~     fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential~     diagnostic and/or prognostic role in the management of these patients which would limit~     invasive biopsy procedures.~   "
149193|NCT01613612|"~     The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell~     implantation combined with core decompression to single core decompression for the treatment~     of avascular necrosis of femoral head.~   "
149194|NCT01613599|"~     This prospective observational study will evaluate the long-term safety of MabThera/Rituxan~     (rituximab) in participants with granulomatosis with polyangiitis (Wegener's) or microscopic~     polyangiitis. Data will be collected for a maximum of 4 years from participants initiated on~     MabThera/Rituxan therapy by their physician according to prescribing information.~   "
149195|NCT01613586|"~     In this study several dose levels of ASP3652, given orally for 12 weeks, will be compared~     with placebo in the treatment of female patients with Bladder Pain Syndrome / Interstitial~     Cystitis.~   "
149196|NCT01613573|"~     The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG~     somatropin, which administered once per week, compared with the daily used somatropin, and to~     evaluate the safety and possibility to replace daily used somatropin.~   "
149197|NCT01613560|"~     This is a phase II, prospective, multi-center, open-label, non-randomized, controlled study.~     The objective of this study is to prospectively verify the relation of efficacy of~     neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary~     adjuvant chemotherapy to predict poor prognosis malignant breast cancer after neoadjuvant~     endocrinotherapy.~   "
149198|NCT01613547|"~     This study will be conducted as a randomized, double-blind, placebo-controlled trial to~     compare routine antibiotic prescription vs. no routine antibiotic prescription in the~     management of uncomplicated cases of severe acute malnutrition treated in the community in~     terms of nutritional recovery. The investigators hypothesize that there will be no~     significant difference in terms of the risk of nutritional recovery among children~     uncomplicated cases of severe acute malnutrition treated in the community that receive~     routine antibiotic prescription and those who receive no routine antibiotic prescription.~   "
149199|NCT01613534|"~     The aim of this study was to compare the efficacy and safety of two treatment regimens: argon~     plasma coagulation (APC) alone and APC in combination with sucralfate administered for~     chronic hemorrhagic radiation proctopathy.~   "
149200|NCT01613521|"~     This study is to assess how patients respond to their treatment for cervical cancer. This~     research does not involve a specific treatment for the cancer that will be recommended by the~     doctor and may include radiation therapy and/or chemotherapy. This is a separate research~     imaging study designed to assess how patients respond to their treatment for cervical cancer.~   "
149201|NCT01613508|"~     The primary aim of the study is to compare the results of an established, successful~     procedure, which is total hip arthroplasty through a mini-posterior approach to a less~     studied - increasingly popular procedure, which is total hip replacement through the direct~     anterior approach utilizing the orthopedic table.~   "
149202|NCT01613495|"~     The purpose of this study is to learn more about how octreotide (Sandostatin LAR® Depot)~     affects levels of ghrelin, hunger, and body weight in people with Prader-Willi Syndrome.~   "
149203|NCT01613482|"~     Evaluate the survival without metastasis in patients treated by Trastuzumab in association~     with other chemotherapies for a breast cancer expressing HER2-NEU.~   "
149204|NCT01613469|"~     This study will assess the complete clinical response (no clinical evidence of remaining~     disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal~     opening after radiation therapy given at the same time as chemotherapy over a 6 week period,~     followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins~     with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6~     weeks for one year.~   "
149205|NCT01613456|"~     The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae~     CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the~     irritable bowel syndrome (IBS)~   "
149206|NCT01613443|"~     Concentration determinations of anticoagulants require plasma instead of whole blood, and~     results are not immediately available to clinicians. Monitoring anticoagulants concentration~     along with bedside methods may provide an alternative guide for administration of the NOAC.~      The purpose of this investigation is to compare bedside coagulation assays in whole blood~     with plasma concentrations of the new oral anticoagulants (NOAC) in patients treated with~     therapeutic dosis of NOAC.~   "
150543|NCT01595997|"~     The overall purpose of this study is to support the development of a DLX105 topical~     formulation for the indication mild to moderate psoriasis vulgaris.~   "
149208|NCT01613417|"~     This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated~     comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects~     with brain tumors to confirm the identical overall technical and diagnostic performance of~     the two MR contrast agents.~   "
149209|NCT01613404|"~     The purpose of the study is to compare the 90 day and 12 month composite end point of death~     (all-cause mortality) and hospitalization in incident hemodialysis patients randomized to~     receive support from a dedicated case manager (intervention group) versus those not receiving~     support from a dedicated case manager (control group).~   "
149210|NCT01613391|"~     This study aimed to measure, compare apelin, resistin, visfatin levels in patients underwent~     to RYGBP, LAGB and their relation with obesity.~   "
149211|NCT01613378|"~     This multi-center, non-interventional study will evaluate the pattern of usage in clinical~     practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients~     initiated on treatment with tocilizumab according to the licensed Canadian product monograph~     recommendations will be followed for 12 months from the start of treatment.~   "
149212|NCT01613365|"~     Despite improvement of per and postoperative management, major pulmonary surgery continues to~     carry out a high morbidity with a significant mortality. Among postoperative complications,~     respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and~     serious, as well as being the primary cause of hospital death, after major pulmonary~     resections. Vast majority of these complications are notoriously infectious and should be~     considered as hospital-acquired infections. These complications result in a dramatic~     increased of substantial hospital costs in term of length of hospital stay, antibiotics and~     morbidity. Current management of these complications stands on antibiotics, oxygen supply and~     physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in~     near 25 % of cases.~      Recent data have suggested that proximal airways colonizations could be an essential first~     step in the pathogenesis of theses respiratory failures. Previous works have long~     demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer~     patients. These colonizations could act as a major predisposing factor to these postoperative~     respiratory failures. Because distal airways and lung parenchyma are free from bacteria at~     the moment of the surgery, respiratory complications should be the result from contamination~     by potential microorganisms belonging the upper aero-digestive tract. Consequently,~     decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first~     days after surgery could have a beneficial advantage in the prevention of these~     complications. This decontamination has been demonstrated to be effective in critically-ill~     patients in intensive care unit, in cardiac surgery and in esophageal surgery.~     Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly~     reduced the rate of postoperative global hospital-acquired infections and respiratory~     infectious as well. To date, data on the efficacy of this decontamination protocol in major~     pulmonary resections are not available.~   "
149213|NCT01613352|"~     The aim was to assess the patient compliance and medical and psychosocial effects of same day~     hospital discharge after breast conserving surgery and sentinel node biopsy only.~   "
149214|NCT01613339|"~     Affected balance capacity is common after a stroke due to paresis and sensory disturbances.~     The affected balance capacity may cause walking disturbances, falls and decreased mobility.~     Balance may be improved by physical therapy. A possible method for balance training is body~     awareness therapy, that was introduced in Sweden by Jacques Dropsy and Gertrud Roxendal.~     Earlier body awareness therapy was mostly used in psychiatric care but in the recent years~     the method has been used for people with long-tern pain, amputations and multiple sclerosis.~     Body awareness therapy includes exercises in lying, sitting and standing. Focus of the~     exercises are awareness of one´s movement behaviour, breathing patterns, resources and~     limitations. Postural control is an essential part in the exercises. Body awareness therapy~     could be used for people with stroke as a way to improve postural control. The aim of this~     study is to investigate if balance training using body awareness therapy can improve balance~     and walking in people after stroke. The interventions consists of body awareness therapy once~     a week for 8 weeks.~   "
149215|NCT01613326|"~     This study compared the efficacy and safety of NVA237 with tiotropium in patients with~     moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.~   "
149216|NCT01613313|"~     The purpose of this research is to evaluate the safest and most effective dose of a Food and~     Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of~     varying sizes that occur commonly in the adult population). The fat in the lipoma is like~     normal fat except that it is enclosed in a balloon-like structure which is made of collagen~     (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks~     down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size~     of the lipoma or removing it.~   "
149217|NCT01613300|"~     The aim of this study is rate of acute graft-versus-host disease II-IV measured at day~     +365according to conventional criteria (Przepiorka et al. 1995) in patients with high risk~     non-Hodgkin lymphoma B subjects with Allogeneic Stem Cell Transplant~   "
149218|NCT01613287|"~     This clinical investigation is a medical device trial to examine the safety and efficacy of~     TheraSorb® Ig flex adsorber treatment (as an add-on to conventional treatment) used~     exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy~     (5 treatments) performed over 5 to 8 consecutive days in patients with Idiopathic Pulmonary~     Arterial Hypertension and WHO functional classification III.~   "
149219|NCT01613274|"~     The purpose of this study is to determine if chewing mint-flavored sugarless gum after colon~     resection surgery decrease the time to first flatus, bowel movement and length of stay in the~     hospital.~   "
149220|NCT01613261|"~     This is a Multicenter, Open-label, Phase 1b Study of TAK-733 in Combination With Alisertib in~     Adult Patients With Advanced Nonhematologic Malignancies~   "
149221|NCT01613248|"~     The purpose of this study is to assess the effectiveness, safety and tolerability of a range~     of doses of MK-1602 versus placebo in the treatment of acute migraine.~   "
149222|NCT01613235|"~     The objective of this multi-centre, randomized controlled trial is to investigate the outcome~     after induced hypertension versus no induced hypertension in patients with delayed cerebral~     ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH), and to assess whether induced~     hypertension results in improved cerebral blood flow (CBF) as measured by means of~     perfusion-CT.~   "
149223|NCT01613222|"~     A 2 phase study to test the accuracy of SpO2 sensors with various patient monitors,~     co-oximeters, and modules.~   "
149224|NCT01613209|"~     The investigators want to find out whether a recently introduced combination of two blood~     pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering~     effect than a single active substance. In addition the investigators want to find out whether~     there is a difference in the changes in blood pressure over the course of a day depending on~     the time when the medications are taken (in the morning or at night). Male and female~     patients over 18 years of age may participate.~   "
149225|NCT01613196|"~     Tuberculosis (TB) remains a major public health problem. In extra-pulmonary forms, evidence~     of bacteriological cure is difficult to be obtained raising the need for other therapeutic~     assessment tools. 18F-Fluoro-deoxy-glucose (FDG) is a glucose analogue widely used in~     Positron Emission Tomography (PET). Its uptake is high in cancer cells and in inflammatory~     cells, especially in active TB foci. The hypothesis is a decrease in the uptake of FDG in the~     foci of TB during treatment permitting a non-invasive monitoring of therapeutic response. The~     main objective is to describe the evolution under treatment of the FDG uptake in PET imaging~     in TB foci in patients cured from lymph node and bone TB. Secondary objectives are to compare~     the decrease of FDG uptake according to type of location, to define the frequency of~     localizations revealed by FDG-PET and their impact on therapeutic management at the beginning~     and the end of treatment, and to describe the evolution of PET in patients not cured.~   "
149226|NCT01613183|"~     The objective of this study is to screen the effective core formulation in insomnia treatment~     with Chinese medicine with a double-blind, randomized, placebo-controlled trial.~   "
149227|NCT01613170|"~     The use of vaginal estrogen cream in conjunction with Toviaz will be more effective than the~     use of Toviaz alone for the treatment of overactive bladder.~   "
149228|NCT01613157|"~     The investigators would like to carry out this study to measure drug levels in HIV-infected~     women that are taking anti-HIV medications. This study will determine the predictors of high~     drug levels and will assess the association of drug levels and adverse events in women.~   "
149229|NCT01613144|"~     This is an Open-label, prospective, randomized, multi-center post-market study.~   "
149230|NCT01613131|"~     Hormonal treatment of perimenopausal women has frequently utilized oral contraceptive pills~     (OCPs). Because of their ability to suppress ovulation and establish cycle control, OCPs have~     become a popular option, and one that is FDA approved for use until menopause. However, use~     of OCPs in women in their 40's and 50's carries significant cardiovascular risks. Venous~     thromboembolism risk is 3-6 fold greater in OCP users, and the risk of myocardial infarction~     (MI) is approximately doubled in OCP users over the age of 40. This occurs at an age where~     the background population risk of MI begins to increase, such that the absolute number of~     cases rises substantially. Women with additional risk factors for cardiovascular disease have~     a much greater risk for MI (6-40-fold) in association with OCPs. There are also large~     subgroups of midlife women who are not candidates for OCP use, such a smokers and~     migraineurs. Moreover, the trend towards lower estrogen dosing with OCPs containing 20~     micrograms of ethinyl estradiol has not led to a detectable decrease in thromboembolic risk.~      Because of their increased potential risks, it is appropriate to seek alternatives to OCPs~     and to explore lower doses of hormones to relieve perimenopausal symptoms that occur prior to~     a woman's final menses. Recent evidence indicates that the hypothalamic-pituitary axis of~     reproductively aging women is more susceptible to suppression by sex steroids that previously~     believed. It is possible that hormone doses as low as 50 micrograms of transdermal estradiol~     (TDE) can suppress the hypothalamic-pituitary axis of midlife women. It is also tempting to~     speculate that the low but measurable circulating doses of levonorgestrel that are present~     when a woman uses the Mirena intrauterine system (IUS) can contribute to or even~     independently suppress the hypothalamic-pituitary axis, and reduce the hormonal fluctuations~     that result in worsening of perimenopausal symptoms. The combination of low dose TDE plus~     Mirena may therefore confer superior symptom control as well as contraceptive effectiveness,~     at far less risk.~   "
149231|NCT01613118|"~     This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor~     antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is~     safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).~   "
149232|NCT01613105|"~     In this prospective, non interventional, observational Post Marketing Survelliance study data~     are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of~     sulfonylurea under daily life treatment conditions.Specifically investigated is the influence~     of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when~     added to an already existing sulfonylurea therapy.The study is planned to carried out in~     25000 - 30000 patients from 200 trial sites in India.The Post Marketing Survelliance study~     will be performed with commercially available medication prescribed within regular practice~     of the physician. No other examination will be performed than would be done without Post~     Marketing Survelliance study.~   "
149233|NCT01613092|"~     The goal of the pilot study is to compare whether a centre-wide policy of incremental~     antibiotic therapy will reduce pacemaker infection compared to a policy of conventional~     antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This~     pilot study will provide feasibility information for a larger cluster randomized crossover~     design (CRCD).~   "
149234|NCT01613079|"~     Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the~     treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized,~     prospective multi-center clinical trial. Observation period of 24 weeks.~   "
149235|NCT01613066|"~     Cord blood (CB) from an unrelated donor is increasingly used an alternative source of~     hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched~     donor. However, the utilization of single-unit CB for transplantation of adult patients has~     been impeded by the low number of nucleated cells available from individual CB units. Direct~     intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose~     problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a~     phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult~     patients with advanced or high-risk hematological malignancies~   "
149236|NCT01613053|"~     Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.~   "
149237|NCT01613040|"~     This multiple-center, multiple-dose, randomized, double-blind, double-dummy,~     placebo-controlled, positive-controlled, parallel group study will investigate the effect of~     RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to~     one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C:~     placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin~     on Day 11. The anticipated time on study treatment is 11 days.~   "
149238|NCT01613027|"~     This observational study will evaluate the effect on disease activity and the safety in~     routine clinical practice of MabThera (rituximab) in participants with active seropositive~     rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor~     inhibitor (anti-TNF) therapies.~   "
149239|NCT01613014|"~     The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly~     percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to~     placebo. A heavy drinking day is 4 or more drinks per drinking day for women and 5 or more~     drinks per drinking day for men.~   "
149242|NCT01612975|"~     Following a lung resection procedure, patients have their pleural space drained of fluid that~     accumulates due to the severing of proximal vessels like lymph nodes. The volume of fluid~     pumped depends on the severity of the inflammation. The investigators are conduction this~     study to attempt to use painkillers with intrinsic anti-inflammatory action to try and reduce~     the degree of inflammation in patients' pleural cavity, thus ensuring patients are discharged~     faster, with a greater comfort level, and a hopefully lower rate of admission.~   "
149243|NCT01612962|"~     In this study, the investigators will perform a retrospective chart analysis of patients that~     underwent a bony debridement or amputation in the operating room at Georgetown University~     Hospital during 2009-2010 under Drs. Steinberg and Attinger. Chart reviews, medical records~     and operative reports via EMR and paper charts will be examined from inpatient records, the~     Center for Wound Healing, the Emergency Department as well as other institutions involved in~     the care of the subjects to gather data.~   "
149244|NCT01612949|"~     The aim of this project is to develop a computer algorithm that can accurately predict how~     easy or difficult it is to intubate a patient based upon digital photographs from three~     different perspectives. Such an application can provide a consistent, quantitative measure of~     intubation difficulty by analyzing facial features in captured photographs - features which~     have previously been shown to correlate with how easy or how hard it would be to perform the~     intubation procedure. This is in contrast to established subjective protocols that also serve~     to predict intubation difficulty, albeit with lower accuracy. A digital application has the~     potential to decrease potential complications related to intubation difficulty and increase~     patient safety.~   "
149245|NCT01612936|"~     The specific hypothesis for this study is that there are fundamental differences in T~     effector and T regulatory cell responses in the lung to allergens in allergic asthma (AA)~     when compared to allergic nonasthmatics (ANA) that account for the difference in clinical~     responses. We will address this by comparing T cell responses in AA versus ANA subjects.~     These experiments will correlate T cell responses with measures of airway physiology using~     state-of-the art lung imaging and examine mechanisms controlling T cell activation in the~     airways of AA and the function of airway T regulatory cells during AA.~   "
149246|NCT01612923|"~     The physical examination before an abortion is usually performed by a physician. However, in~     many countries access to physicians is limited. To increase access to safe abortion this~     study wishes to examine if midlevel providers such as specially trained midwives can provide~     safe abortion services. Midwives in study were specially trained to perform early pregnancy~     ultrasound and if needed to consult a physician. The midwife then provided the abortion~     service as well as the contraceptive advice. Women were randomized to receive the service~     from a midwife or a physician.~   "
149247|NCT01612910|"~     This study is being done to find out whether a nutritional supplement, called BioResponse-DIM~     (BR-DIM [oral microencapsulated diindolylmethane]), improves the survival for women who have~     residual cancer cells following surgery after chemotherapy for breast cancer. BR-DIM is an~     active ingredient in cruciferous vegetables (broccoli, brussels sprouts and cauliflower).~     Consumption of these vegetables has been associated with a decreased risk in several cancers.~     Researchers also hope to find out whether different biomarkers (also called markers) in the~     blood predict the chance of breast cancer returning. BR-DIM is thought to be effective in~     treating stage II-III breast cancer that is triple negative, AR positive (+), and where there~     is residual cancer cells in the breast after chemotherapy.~   "
149248|NCT01612897|"~     The investigators hypothesize that children seen in a clinic that uses a compute based system~     known as CHICA, which reminds pediatricians to screen at defined time point for autism, will~     be screened more consistently for autism and receive more timely diagnostic a treatment~     services.~   "
149249|NCT01612884|"~     Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize~     safety of coronary stenting by reducing heart attacks and repeat interventions while~     simultaneously minimizing adverse bleeding events. This study compares the efficacy of two~     laboratory guided treatment algorithms to personalize antiplatelet medication choice after~     coronary stenting~   "
149250|NCT01612871|"~     This is a biomedical and prospective study of interventional type. The trial will include 29~     patients over a period of 15 months + 24 months of follow up maximum.~      The study will be conduct in womens with metastatic invasive breast cancer or locally~     advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line~     hormone therapy for metastatic breast cancer) is indicated.~      The main objective of this pilot study is to evaluate the feasibility to detect in the~     circulating blood of patients, before treatment (T0), the presence of the fifteen tissular~     microRNAs described in preclinical studies as possibly involved in hormone~     resistance/sensitivity.~      In parallel of the detection of these specific miRNAs, we will conduct a larger scale~     analysis of circulating miRNAs in these patients before (T = 0) and after one month of~     treatment (T28).~   "
149251|NCT01612858|"~     The purpose of this study is to examine the relationship between insulin resistance and~     changes in body fat distribution in HIV-infected persons. This study measures insulin~     sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the~     effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body~     fat in this population.~   "
149252|NCT01612845|"~     The objective of this study was to prospectively evaluate the influence of local application~     of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically~     repaired tendons in patients with massive tears of the rotator cuff.~   "
149266|NCT01612663|"~     The purpose of this study is to test if specific therapeutic benefits of acupuncture are~     mostly attributable to contextual and psychosocial factors, such as patients' beliefs and~     expectations.The investigators propose using the 2 acupuncture methods, which refrains from~     inserting needles in the affected area, in order to evaluate the short-term and long-term~     efficacy of acupuncture in a clinical setting compared with placebo and compared with~     invasive needling that does not adhere to correct acupuncture rules.~   "
149267|NCT01612650|"~     This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a~     significant decrease of ultrasound cliches (and radiation exposure)~   "
153355|NCT01559038|"~     The current study will assess the real - life effectiveness of adalimumab in the management~     of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis~     (PsA).~   "
149253|NCT01612832|"~     Background:~      Proper pain relief is a major concern of patients worldwide. Preoperatively, one of the most~     common questions asked by patients pertains to the amount of pain they will experience after~     surgery how long it will last and how good will it be controlled. Pain concerns the surgical~     team as well, because of its correlation with clinical outcomes and patients' satisfaction~     rate. Studies have shown that negative clinical outcome with regard to pain control includes~     decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia, hypertension,~     myocardial ischemia, transition into chronic pain, poor wound healing, and psychological~     sequelae .~      Pain has been found to be one of the three most common medical causes of delayed/aborted~     discharge after ambulatory surgery, the other two being drowsiness and postoperative~     nausea/vomiting. Despite progress that has been made with regard to postoperative pain~     control, and the development of new standards for pain control, many patients continue to~     experience intense pain after surgery .~      Recent advances in the understanding of the particularities of central sensitization indicate~     that it plays an important role in post surgical and post traumatic pain and therefore should~     be avoided~   "
149254|NCT01612819|"~     Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients~   "
149255|NCT01612806|"~     To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the~     treatment of venous leg ulcers (VLUs).~   "
149256|NCT01612793|"~     This study will look at the safety, improving symptoms and decreasing the length of stay of~     patients admitted to the hospital with COPD.~   "
149257|NCT01612780|"~     The purpose of this study is to show clinically meaningful improvement in symptom severity~     after trans-nasal balloon dilation of the maxillary sinus outflow tract with or without~     balloon dilation of the frontal or sphenoid sinuses.~   "
149258|NCT01612767|"~     The purpose of this study is to demonstrate the safety and efficacy of the investigational~     BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native~     coronary arteries.~   "
149259|NCT01612754|"~     Aim of Study: Adverse effects from noise pollution in operation theatres have been throughly~     demonstrated. We assessed the impact of a noise reduction program in paediatric surgery.~      Methods: A prospective controlled study on 156 operations performed by 16 surgeons was~     conducted. The sound levels before and after a noise reduction program based on education,~     rules and technical devices (Sound Ear tm) were assessed. Endpoints were spatially resolved~     sound levels matched by the surgeon's biometric (saliva cortisol, electrodermal activity) and~     behavioural stress responses (questionnaires). These were correlated with mission protocols~     and NoiSeQ for individual noise sensitivity.~   "
149260|NCT01612741|"~     In this prospective, non interventional, observational Post Marketing Survelliance study data~     are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of~     metformin under daily life treatment conditions.Specifically investigated is the influence of~     Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added~     to an already existing metformin therapy.The study is planned to carried out in 25000 - 30000~     patients from 200 trial sites in India.The PMS study will be performed with commercially~     available medication prescribed within regular practice of the physician. No other~     examination will be performed than would be done without Post Marketing Survelliance study.~   "
149261|NCT01612728|"~     Aromatase inhibitors are the most effective adjuvant anti-hormonal therapy for estrogen~     receptor positive (ER+) post-menopausal breast cancer patients, with proven superiority over~     tamoxifen in terms of disease-free survival, time to recurrence, and contralateral breast~     cancer. However, approximately half of the women who take this drug will develop significant~     joint pains, termed Aromatase Inhibitor-Induced Arthralgia (AIA). Though this medicine should~     be taken for 5 years, the joint pain can be so troublesome that up to 13% may prematurely~     discontinue it because of the arthralgia, thus sacrificing their best chance of~     recurrence-free survival. Nonetheless, neither the etiology nor optimal management of AIA is~     clearly understood, leaving both doctor and patient rather frustrated.~      The investigators therefore propose to test the hypothesis that AIA can be effectively~     treated by a new clinical algorithm, and that effective treatment of the problem will lead to~     improved compliance with Aromatase Inhibitor (AI) therapy. The algorithm is a clinical~     pathway for treating AIA which incorporates, in a rational and step-wise manner, a series of~     interventions based on the available evidence. Interventions include acupuncture, pain~     medication, weight bearing exercise, and other commonly used therapies for AIA.~      The investigators will enroll 100 women who are beginning adjuvant AI therapy and assess each~     woman's baseline joint pains via a questionnaire as well as grip strength measurement. The~     investigators will then periodically repeat these tests during AI therapy in order to~     systematically quantify and characterize AIA. Those women who develop AIA during the course~     of the study will be placed on the clinical algorithm, and the investigators will observe~     whether their joint pains significantly improve (as measured by questionnaire and grip~     strength measurement) after institution of the algorithm. The investigators will also~     determine whether their compliance is improved compared to historical controls, and at least~     non-inferior to the women in the study who do not develop AIA. Finally, the investigators~     will measure serum estrogen level at baseline and then periodically during AI therapy to~     investigate whether more dramatic decline in estrogen level after initiation of an AI leads~     to significant AIA and earlier time to onset.~      This study targets a very common cause of pain among breast cancer survivors and aims to~     offer an effective treatment strategy to alleviate pain and improve quality of life as well~     as medication compliance.~   "
149262|NCT01612715|"~     Cat allergies are a major trigger of asthma. Therapies are being developed to control the~     allergic response to cats. We are interested in measuring a type of white blood cell which is~     linked to cat allergies, which will help us understand how to use new therapies in people who~     suffer from cat allergies and asthma. We will study cat-allergic individuals with stable,~     mild asthma who will be exposed to cat allergens. We will measure various white blood cells,~     including the cells that are linked to cat allergies, to determine whether the number of~     these cells changes following cat exposure. These cells will be measured from the blood and~     bone marrow by removing samples using a needle. These cells will also be measured from the~     lungs by inserting a bronchoscope into the airways and drawing up fluid containing cells.~     This study will improve our understanding of the harmful versus protective role of these~     cat-specific cells, and will allow for development of better drugs for treatment of asthma~     triggered by cat exposure.~   "
149263|NCT01612702|"~     This study was conducted to determine the efficacy of an additional preemptive, single,~     low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting~     (PONV), pain level, and the safety in terms of wound complications in patients managed with~     our antiemetic protocol based on Ramosetron following TKA.~   "
149264|NCT01612689|"~     This is a prospective, unblinded sub-study to the E-30 to gather physiological data.~   "
149265|NCT01612676|"~     The purpose of this trial is to investigate the potential of FE 202158 as a treatment which~     can stabilize blood pressure for treatment of patients in early septic shock.~   "
149303|NCT01612182|"~     The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement~     therapy.~   "
149268|NCT01612637|"~     Purpose The aim of this study is to examine if a structured pelvic floor muscle training~     combined with lifestyle advice with can improve pelvic organ prolapse (POP) symptoms more~     than structured lifestyle advice programme alone.~      Background Pelvic organ prolapse (POP) is a common condition among adult women and almost one~     in ten women experience symptoms caused by POP. The key symptom of POP is seeing or feeling a~     bulge in the vaginal opening but POP often gives other symptoms, such as pain, difficulty~     emptying the bladder or the bowel, incontinence and sexual problems such as dyspareunia.~      A majority of women with POP will be offered reconstructive surgery but the risk of~     reoperations is substantial and surgery may cause new symptoms. In one out of four women~     surgery does not relieve symptoms and the women have been exposed to unnecessary risk of~     complications.~      It is therefore important to evaluate the effect of conservative treatments for POP. New~     studies have shown that pelvic floor muscle training offered in combination with lifestyle~     advice has a significant on POP symptoms and objective measures of POP compared to a~     lifestyle advice leaflet alone.~      No studies have compared the effect of a combined pelvic floor muscle training and lifestyle~     advice programme with a structured programme of lifestyle advice and hypothetically the~     structured lifestyle advice programme could have a substantial effect on its own. Our~     hypothesis is that the pelvic floor muscle training is a vital component of a conservative~     treatment for POP.~      Methods In this single-blind randomised controlled study women with POP will randomised to~     either a programme of structured pelvic floor muscle training combined with lifestyle advice~     or a structured lifestyle advice programme alone. Both groups will receive the same lifestyle~     advices through six (separate) lectures within 12 weeks. The training group will be examined~     and individually instructed in pelvic floor muscle training before the intervention starts~     and they will, in continuation with their lifestyle lectures, perform pelvic floor muscle~     training as group training~   "
149269|NCT01612624|"~     Rationale: Acromegaly is the clinical syndrome that results from an excess of growth hormone~     (GH). Craniofacial and hand disproportions due to soft tissue swelling and new bone formation~     are highly prevalent in patients with active acromegaly. Besides the cosmetic aspects, these~     changes can impair the quality of life because of the significant morbidity with respect to~     oral, maxillofacial and hand pathologies as well as respiratory problems such as sleep apnea~     and changes in speech. At present it is unclear if these craniofacial and hand~     disproportions, sleep apnea and speech changes are (partially) reversible after successful~     treatment. Therefore there is no consensus about the information patients should be given~     about (partial) recovery of facial and hand disproportions after treatment and how the~     follow-up with respect to oral, maxillofacial, respiratory and hand pathology should be~     organized. Facial and hand analysis using a 3D stereophotograph and a 3D fusion model of a 3D~     stereophotograph and a 3D skull reconstruction via cone beam computed tomography (CT)-scan~     makes it possible to investigate the craniofacial changes due to acromegaly in all facial~     dimensions together (dentition, bone and soft tissue) and the relational proportions between~     these facial structures. 3D stereophotography can do the same for the soft tissues of the~     hand. Combined with disease specific and general quality of life (QOL) questionnaires, a~     correlation between quality of life and craniofacial and hand disproportions can be~     determined. Combined with sleep- and speech analysis, a correlation between sleep apnea,~     speech and craniofacial disproportions can be determined.~      Primary objective: To investigate the changes in facial- and hand analysis in patients with~     acromegaly as a result of medical treatment and pituitary surgery, and to investigate the~     changes in relational proportions between facial- and hand structures, incidence and severity~     of sleep apnea, incidence and severity of speech changes and QOL.~      Study design: a prospective case-control study. Study population: Approximately thirty~     patients newly diagnosed with acromegaly . The results of facial and hand analysis, sleep~     apnea research and speech analysis of the patient group in different phases of the disease~     will be compared to the results of a healthy control group.~      Main study parameters/endpoints: Parameters of facial analysis with 3D stereophotography and~     cone beam CT and hand analysis with 3D stereophotography , biochemical parameters of disease~     activity, disease related QOL assessed by 2 validated QOL questionnaires (,the AcroQol and~     RAND-36 ), speech analysis, the results of the voice handicap index questionnaire and~     severity of sleep apnea assessed by complete overnight polysomnography and the Epworth~     sleepiness scale questionnaire.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: As a result of participating in this study, subjects have to undergo a cone beam~     CT. The cone beam CT is associated with exposure to X-ray radiation of 0.069-0.135mSv. This~     is the same amount of radiation as the amount of background radiation that each person~     receives in 7 days time during daily life. No adverse effects are expected from this amount~     of exposure. The investigations will take 10-70 minutes adjacent to every regular outpatient~     clinic visit. In addition , for polysomnography, subjects will be investigated overnight one~     or three times in 2,5 years, depending on the results of the first screening polysomnography.~      Assessment of changes in body appearance, sleep disturbances, speech changes and QOL in a~     prospective longitudinal fashion will increase the knowledge of the impact of the disease on~     patient perception of well-being and functioning and will help us refine the treatment goals~     in patients with acromegaly~   "
149270|NCT01612611|"~     The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai~     injection in hospital results in adverse events or adverse drug reactions.~   "
149271|NCT01612598|"~     Patients enrolled in phase I clinical trials could potentially benefit from palliative care~     concurrently, yet limited evidence is available to support such a change in care. The primary~     purpose of this study is to test the feasibility of a palliative care intervention (PCI) for~     patients participating in a phase I therapeutic clinical trial~   "
149272|NCT01612585|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke and~     coronary heart disease in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 30,000 patients.~   "
149273|NCT01612572|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia~     、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children~     acute hot diseases in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 20,000 patients.~   "
149274|NCT01612559|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      Kudiezi is kind of Chinese Medicine injection used for treating coronary heart disease and~     angina pectoris in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 30,000 patients.~   "
149275|NCT01612546|"~     This pilot clinical trial studies cyclodextrin-based nanopharmaceutical CRLX101 in treating~     patients with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that has~     progressed through at least one prior regimen of chemotherapy and cannot be removed by~     surgery. CRLX101 delivers the cytotoxic topoisomerase-1 inhibitor camptothecin into tumor~     cells and is hypothesized to interrupt the growth of tumor cells.~   "
149276|NCT01612533|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart~     disease in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 20,000 patients.~   "
149277|NCT01612520|"~     The objective of the study is to analyze the effectiveness and the cost-effectiveness of~     telecoching in improving glyceamic control and other modifiable risk factors in patients with~     type 2 diabetes compared to usual care only.~   "
149278|NCT01612507|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     different dose regimens of Ceftaroline~   "
149279|NCT01612494|"~     This single center, blinded, randomized controlled trial evaluated the use of hypertonic~     saline versus normal saline as therapy for the symptoms of pediatric concussion post head~     injury.~      The study hypothesis was that hypertonic saline would improve symptoms of pediatric~     concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale~     as compared to normal saline.~      The null hypothesis was that there would be no difference in change of reported pain in~     either group.~   "
149280|NCT01612481|"~     Cancer surveillance has a significant cost and generate anxiety for the patient.~      It is important to avoid exams that will not modify health support or whose results wont~     allow to decide.~   "
149281|NCT01612468|"~     A randomised, double-blind, placebo controlled study of the effect of liraglutide as an~     additional treatment to insulin on HbA1c, body weight and hypoglycaemia in poorly regulated~     type 1 diabetes patients.~      Background: Treatment with glucagon-like peptid 1 (GLP-1) agonists liraglutide and exanatide~     leads to weight loss and decrease in haemoglobin A1c in oral anti diabetic treated type 2~     diabetes patients.~      It is estimated that 40-50 % of type 1 diabetes patients in the US suffers from overweight or~     poor glycaemic control (HbA1c > 8 %).~      Small studies, not placebo controlled, reports effects of adding liraglutide to a group of~     well regulated (HbA1c < 7.5 %) normal to overweight insulin treated type 1 diabetes patients~     for 24 weeks. A decrease in HbA1c, weight, insulin doses and glycaemic excursions measured by~     continuous glucose monitoring was seen.~      Primary objective:To investigate the effect of liraglutide 1.8 mg once daily compared to~     placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an add-on therapy~     to insulin. Secondary objectives:To investigate the effect of liraglutide as an add-on~     therapy to insulin compared to placebo on change in:Weight, insulin dose,hypoglycaemic~     events, CGM, BMI, body composition, quality of life, treatment satisfaction,food preferences,~     meal test, CIMT, PWV and 24 hour blood pressure.~   "
149282|NCT01612455|"~     The purpose of this study is to implement and assess a behavioral and structural intervention~     in Russia designed to support and motivate HIV-infected narcology heroin dependent patients~     (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care and ultimately improve~     their HIV outcomes. The central hypothesis is that an intervention that involves coordination~     between the narcology and HIV systems via HIV case management delivered by a peer to help~     motivate and reduce barriers to HIV care will lead to engagement in HIV care.~   "
149283|NCT01612442|"~     In Ghana the level of malnutrition is high among children below five years of age,~     particularly in rural areas. The objective of the study was to investigate the effects of an~     education intervention aimed at addressing poor complementary feeding (CF) practices on the~     food intakes and growth of young children in the Upper Manya Krobo district of Ghana.~      Interviews and focus group discussions involving community health and agricultural workers,~     as well as caregivers of children 6-24 months old were conducted to investigate the~     facilitators and challenges to optimal CF practices and education on CF. The trials of~     improved practices (TIPs) method was used to test the feasibility and acceptability of~     potential education messages among mothers of young children (6-24 months) living in the~     study area. Child welfare clinic centers in the area were randomly assigned to one of three~     groups which were control, nutrition education and integrated education. Mothers of children~     6-24 months in the integrated education group received monthly nutrition education from~     community health volunteers and agricultural education from agricultural extension agents for~     six months in addition to standard monthly child growth monitoring services from community~     health nurses. Mothers in the nutrition education group received monthly nutrition education~     from community health volunteers for six months in addition to standard care. Mothers of 6-24~     months in the control group received only the standard monthly child monitoring services. The~     effects of the educational intervention on maternal knowledge on optimal complementary~     feeding, as well as food intakes and growth of young children were determined among 367~     mother-child dyads over a period of at least six months. The study hypothesised that mothers~     receiving the education would have improved knowledge on good complementary feeding practices~     compared to those in the control group. The study also hypothesised that young children in~     the integrated education would have better nutrient intakes and growth compared those in the~     nutrition education and control groups, and those in the nutrition education group would have~     better nutrient intakes and growth than the children in the control group.~      From the interviews and focus group discussions, reported initiation of CF was satisfactory,~     while other reported practices such as the addition of animal source foods, vegetables and~     fruits to young children's diet were found to be sub-optimal. Poverty and maternal time~     constraints were identified as the main challenges of optimal complementary feeding, while~     farming was seen as a facilitator. Lack of education materials, language barrier, maternal~     time constraints and lack of in-service training for health workers were the main challenges~     to education on complementary feeding. From the TIPS study, mothers expressed their~     willingness to improve the diets of their 6-24 months old children by adding or increasing~     the amount of animal source foods, dark-green leafy vegetables and fruits, as well as~     increasing feeding frequency daily. However, availability and affordability of protein-rich~     foods like animal source foods, groundnut paste and soya beans powder was a challenge for~     some mothers.~      The intervention did not lead to a significant improvement in maternal knowledge on~     complementary feeding practices. However, it showed a tendency to reverse a general~     decreasing trend in knowledge among mothers on appropriate complementary feeding practices in~     the study area. Significantly more children in the integrated education group consumed animal~     source foods compared those in the other two groups when compared at nine months after~     baseline. However, the intervention did not improve the general nutrient intakes and growth~     of the young children in the study area.~   "
149284|NCT01612429|"~     This is a pilot study to evaluate the effects of amino acid supplementation on the structure~     of certain proteins in the blood of dialysis patients. Patients with end stage renal disease~     (ESRD) usually have high levels of urea that may interact with blood proteins and change~     their structure by a process known as carbamylation. The investigators are interested in~     determining whether carbamylation is linked to adverse outcomes in dialysis patients and have~     hypothesized that supplementation with a balanced formulation of amino acids can reduce the~     amount of carbamylation that occurs. In this study, dialysis patients (n= up to 30) will~     receive intravenous supplementation with an FDA-approved amino acid solution (NephrAmine®,~     5.4% amino acids) during regular dialysis sessions (3 times weekly for 6 weeks). During the 6~     weeks of therapy and for 2 weeks of follow-up, blood will be drawn from patients' existing~     hemodialysis access ports (~60 ml total per month) to measure levels of carbamylated albumin,~     amino acids, and standard laboratory values. Patients will be closely monitored for safety~     and tolerability of the amino acid therapy. For each treated subject, we will follow an~     additional individual that is not receiving treatment to serve as a control (no~     intervention).~   "
149285|NCT01612416|"~     The aim of this study is to examine whether there is a difference in macular ganglion cell~     complex thickness and retinal nerve fiber layer thickness in early-stage Primary open angle~     glaucoma and normal tension glaucoma with spectral domain OCT.~   "
149286|NCT01612403|"~     There are several causes leading to male infertility, like oxidative stress, and nutritional~     deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three~     types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands~     (LMW). The present study was conducted to study the effect of Zn supplementation on the~     quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels~     in semen of patients with asthenozoospmia.~   "
149287|NCT01612390|"~     Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third~     and fourth stages of labor~   "
149288|NCT01612377|"~     This study will compare an experimental drug called Z102 (combination of prednisolone and~     dipyridamole, against prednisone 5mg and prednisone 7.5mg in patients with moderate to severe~     Rheumatoid Arthritis for a period of 52 weeks.~   "
149289|NCT01612364|"~     This is a double-blind randomized controlled trial to evaluate the efficacy of the~     sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients~     with CRPS I refractory to medical treatment will be subjected to four physical therapy~     sessions and then the randomized for experimental or control block and then more four~     physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary~     outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain~     inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and~     WHOQOL-brief).~   "
149290|NCT01612351|"~     The purpose of this study is to see if a three method risk adapted design using induction~     chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make~     treatment of squamous cell carcinoma of the head and neck (SCCHN) better.~   "
149291|NCT01612338|"~     The University of Michigan (UM) Schools of Nursing, Public Health, and Medicine, the Michigan~     Department of Community Health (MDCH) and the Michigan Cancer Consortium (MCC) are conducting~     a multidisciplinary academic/practice three-year project to increase appropriate breast~     cancer screening for young breast cancer survivors and their cancer-free, female relatives at~     greatest risk for breast cancer. The aims of this project are to: 1) identify and survey 3000~     breast cancer survivors reported to the Michigan Cancer Surveillance Program who were~     diagnosed between the ages of 20-45 years regarding their breast cancer screening~     utilization; 2) identify and survey the survivors' female relatives regarding their breast~     cancer screening utilization; and 3) implement two versions (targeted vs. enhanced tailored)~     of an evidence-based intervention recommended by the Guide to Community Preventive Services~     to increase breast cancer screening. A follow-up survey will assess the effectiveness of each~     intervention on a) breast cancer screening utilization; b) perceived barriers and~     facilitators to screening; c) self-efficacy in utilizing screening services; d) family~     support related to screening; e) knowledge of the genetics of breast cancer and personal risk~     factors; and f) satisfaction with the intervention.~   "
149292|NCT01612325|"~     Radioembolisation is a known method for the treatment of liver tumors and or livermetastases.~     Currently small beadlets called microspheres are used that are loaded with the beta radiation~     emitting Yttrium-90. Holmium-166 microspheres have different physical characteristics~     including good visualisation in gammacameras due to the gamma emission. Because of the higher~     specific activity higher radiation doses to the liver will be used compared to the standard~     Yttrium treatment. It is hypothesized that higher doses of irradiation have an improved~     antitumor effect.~   "
149293|NCT01612312|"~     Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is~     recommended by current guidelines, there are insufficient data to unequivocally support~     thrombectomy in patients with non-STEMI (NSTEMI). The Thrombus Aspiration in ThrOmbus~     containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial is~     a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. The~     hypothesis is that under the background of early revascularization, adjunctive thrombectomy~     in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less~     microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in~     patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two~     treatment arms. The primary endpoint is the extent of MO assessed by CMR. Secondary endpoints~     include infarct size and myocardial salvage assessed by CMR, enzymatic infarct size as well~     as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow post-PCI and~     myocardial blush grade. Furthermore, clinical endpoints including death, myocardial~     reinfarction, target vessel revascularization and new congestive heart failure will be~     recorded at 6 and 12 months. Safety will be assessed by bleeding and stroke. In summary, the~     TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve~     myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit~     vessel reperfused by early PCI.~   "
149294|NCT01612299|"~     Primary objectives: A. To evaluate the effect of Zortress® versus standard immunosuppression~     therapy on progression of CAC as evidenced by changes in Agatston scores from baseline and at~     6, and 12 months in renal transplantation patients. B. To investigate progression of CAC in~     patients undergoing renal transplantation within the study period.~      Secondary objectives:~        1. To evaluate in renal transplantation the effect of Zortress® versus standard~          immunosuppression therapy on bone mass as evidenced by changes in quantitative computed~          tomography (QCT) and dual energy X-ray absorptiometry (DXA).~        2. To evaluate in renal transplantation the effect of Zortress® versus standard~          immunosuppression therapy on activity of bone forming and resorbing cells as evidenced~          by changes in bone histology.~        3. To evaluate in renal transplantation the effect of Zortress® versus standard~          immunosuppression therapy on biochemical parameters of bone turnover as evidenced by~          changes in serum Parathyroid Hormone (PTH), Bone-Specific Alkaline Phosphatase (BSAP),~          Tartrate-Resistant Acid Phosphatase (TRAP), Sclerostin, Receptor Activator of Nuclear~          factor Kappa B Ligand (RANKL), Osteoprotegerin (OPG), , serum CTX (C-terminal~          telopeptide of type 1 collagen), and urinary NTX (N-terminal cross link telopeptide).~        4. To evaluate in renal transplantation the effect of Zortress® versus standard~          immunosuppression therapy on cardiovascular events, graft rejection and patient~          survival.~   "
149295|NCT01612286|"~     The investigators designed this study to evaluate the efficiency and the acute toxicities of~     recombinant human endostatin (endostar) combined with chemotherapy in the metastatic~     nasopharyngeal carcinoma (NPC).~   "
149296|NCT01612273|"~     To explore the efficacy of triflusal in patients with symptomatic peripheral microcirculation~     dysfunction. Triflusal is a salicylate compound approved in several countries as~     antithrombotic agent and it additionally has vasodilatory effect. The hypothesis is to~     explore if there is a improvement of peripheral microcirculation by triflusal.~   "
149297|NCT01612260|"~     The purpose of this study is to assess the effects of Chinese medicine Shensong Yangxin~     capsule for the chronic cardiac dysfunction complicated with ventricular premature beats.~   "
149298|NCT01612247|"~     Patients with stage II-III breast cancer who do not achieve a pathologic complete response to~     neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose continuous~     cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and~     radiotherapy. The primary endpoint is to assess toxicity and safety with secondary endpoints~     of cytokine correlates and relapse free survival (RFS) at 2 years. The investigators design~     tests the null hypothesis (H0) that the true primary toxicity event rate will be 5% or less,~     against an alternative hypothesis (HA) event rate of 25% or more.~   "
149299|NCT01612234|"~     High intakes of saturated fat are associated with diabetes. Our work has shown that the two~     most common fatty acids in the North American diet, palmitic acid (saturated fat) and oleic~     acid (monounsaturated fat) are metabolized differently and have opposite effects on fat~     burning. The proposed study will examine biochemical and molecular mechanisms for how a high~     saturated fat diet versus a low saturated fat/high monounsaturated fat diet alters the action~     of the hormone, insulin, in skeletal muscle.~   "
149300|NCT01612221|"~     This is a phase II intervention to propose a new melanoma chemoprevention agent. The~     investigators believe oxidative stress/damage in nevi is a probable indication for melanoma~     risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi~     from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate~     whether administration of NAC around the time of UV exposure will reduce melanoma risk in~     high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and~     2) examine key genetic variants that will identify which individuals are most likely to~     benefit from chemoprotection.~   "
149301|NCT01612208|"~     The objective of this study is to document callus formation and healing of fractures~     stabilized with locking plates utilizing modern MotionLoc screws that provide controlled~     axial micro-motion to actively promote fracture healing.~   "
149302|NCT01612195|"~     Anal abscess-fistula disease is of common occurrence and has a significant impact on the~     quality of life of affected individuals. The course of abscess-fistula disease as well as its~     treatment modalities may affect anal continence. The present cohort study investigates the~     results of anal fistula plug surgery. In particular, this study focus on the impact of anal~     fistula plug surgery on fistula healing, quality of life, and anal continence. Fifty patients~     will be included and followed up at 6 weeks and 6 months after surgery in the clinic of~     participating surgeons.~   "
149304|NCT01612169|"~     Primary Objective: This study will evaluate the most effective strategy in achieving HIV~     virologic suppression among HIV-infected substance users recruited from the hospital setting~     who are randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN); 2)~     Patient Navigator + Contingency Management (PN+CM); and 3) Treatment as Usual (TAU).~      Primary Hypothesis: The rate of viral suppression (plasma HIV viral load of <= 200 copies/mL)~     relative to non-suppression or all-cause mortality in the 3 study groups will differ from~     each other at the 12 month follow-up.~      Sub-hypothesis 1. The rate of virologic suppression (plasma HIV viral load of <= 200~     copies/mL) in the PN+CM group will be greater than that in the TAU group.~      Sub-hypothesis 2. The rate of virologic suppression in the PN+CM group will be greater than~     that in the PN group.~      Sub-hypothesis 3. The rate of virologic suppression in the PN group will be greater than that~     in the TAU group.~      Secondary Objectives:~        1. To evaluate the effect of the experimental interventions on: HIV virological suppression~          and CD4 T-cell count changes at 6 months post-randomization; engagement in HIV primary~          care and visit attendance; and rate of hospitalizations.~        2. To evaluate the effect of the experimental interventions on: drug use frequency and~          severity; and drug use treatment engagement and session attendance.~        3. To assess selected mechanisms of action of the intervention (.i.e. mediators of~          intervention effect).~        4. To assess potential characteristics associated with differential treatment effectiveness~          (i.e. moderators of intervention effect).~        5. To evaluate the incremental cost and cost-effectiveness of the interventions.~   "
149305|NCT01612156|"~     The purpose of this study is to determine a difference in patient reported pain levels~     before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel~     or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when~     compared to lubricant gel.~   "
149306|NCT01612143|"~     This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess~     the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule~     formulation in healthy volunteers. Subjects will be randomized to one of four treatment~     sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule~     formulation with or without a high fat meal, with a washout period of at least 14 days~     between treatments.~   "
149307|NCT01612130|"~     The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg~     in single oral doses one hour preoperative as conscious sedation during the impacted lower~     third molar surgery.~   "
149308|NCT01612117|"~     Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine~     (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular,~     uNGAL has been used for early detection of AKI in the emergency department, after~     cardiopulmonary bypass or following CM administration.~      This study will be conducted to assess the possible value of urinary Neutrophil~     Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy~     (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP)~     and whether or not uNGAL correlates with the volume of contrast medium (CM) used.~   "
149309|NCT01612104|"~     The purpose of this pilot-study is to evaluate a cognitive behavioral method Psychological~     First Aid used with a group of children (11-16 years) in high risk of developing~     psychological problems. Participants are recruited from a low-threshold program (The~     Children's House in Oslo) where counseling is given to children suspected of being~     physically or sexually abused, or having witnessed domestic violence. The study includes~     twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological~     problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed~     at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be~     assessed daily.~   "
149310|NCT01612091|"~     The Mobile Messenger is a unified, portable and intelligent device that integrates~     information from multiple patient monitors, mechanical ventilators, infusion pumps and~     clinical information systems on a mobile platform. It will allow nurses, respiratory~     therapists and physicians to continuously monitor and coordinate care of critically ill~     patients. This study will use a participatory design process to guide the design of an~     integrated mobile device. Next, we will evaluate the proposed device in a simulated ICU~     setting.~   "
149311|NCT01612078|"~     Orthostatic hypotension is a major complication of hemodialysis and interferes with everyday~     activities in hemodialysis patients. Since information regarding the use of droxidopa in~     clinical trials relating to orthostatic hypotension of chronic hemodialysis patients is~     limited in Taiwan, this study is designed for evaluation the efficacy and safety profile of~     droxidopa on orthostatic hypotension treatment / prevention in hemodialysis patients.~   "
149312|NCT01612065|"~     Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal~     route is the best, optimum dose not yet known.~   "
149313|NCT01612052|"~     The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides~     coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive~     bacteria, and some gram-negative bacteria which may not be adequate antibiotic treatment at~     the time of vascular surgery and result in an increased hospital length of stay, increased~     cost of care, and an increased risk of morbidity and mortality as a consequence of surgical~     site infections. Thus, the investigators want to compare whether Methicillin-resistant~     Staphylococcus Aureaus (MRSA) antibiotic prophylaxis with Cefazolin plus Daptomycin is~     superior to Cefazolin plus Vancomycin in the reduction of surgical site infection (SSI)~     following open arterial revascularization procedures requiring a groin plus lower extremity~     incision. The investigators hypothesis is that Cefazolin plus Daptomycin is superior to~     Cefazolin plus Vancomycin in the prevention of SSI for high risk patients undergoing open~     groin plus lower extremity procedures.~   "
149314|NCT01612039|"~     This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study.~     Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be~     randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000~     mg/d) or matching placebo in a 1:1 ratio for 8 weeks.~      The study hypothesis is that treatment with ASP3291 compared to placebo will improve a~     patient's ulcerative colitis endoscopic score from baseline to Week 8.~   "
153959|NCT01551108|"~     This study is designed to determine if parents can deliver an intervention that will help~     increase physical activity in their children. The parents will be given the intervention~     through their mobile phones.~   "
149315|NCT01612026|"~     In the investigators vascular practice, either fluoroscopic- or ultrasound-guided technique~     is routinely used to obtain femoral arterial access. Ultrasound-guidance is frequently used~     in patients with weak or absent pulses, known abnormal vascular anatomy, need for bypass~     graft puncture, and to ensure accurate arterial puncture in patients expected to receive~     large doses of blood-thinning medications during or after the procedure. For those~     practitioners experienced with ultrasound-guided access techniques, it is considered highly~     accurate and easy to use; thus, some physicians routinely use this tool. A well-designed~     study is needed to truly assess the accuracy of the ultrasound technique and to determine~     whether it may reduce complications of arterial access in vascular patients.~      By demonstrating the safest, most accurate and efficient technique for obtaining arterial~     access during catheter-based procedures, the investigators could significantly reduce~     morbidity and mortality associated with complications of arterial puncture. Length of~     hospital stay, management costs and patient discomfort could be reduced by minimizing~     complication rates.~   "
149316|NCT01612013|"~     Contrast-induced acute kidney injury is a common cause of acquired in-hospital renal~     insufficiency and is associated with prolonged hospitalization and unfavorable early and late~     outcomes. The investigators sought to compare 4 different strategies (intravenous high-dose~     of N-acetylcysteine, sodium bicarbonate, the combination of both, and saline alone) in the~     prevention of contrast-induced acute kidney injury in patients undergoing coronary~     angiography using high-osmolar contrast media defined by creatinine and cystatin C serum~     levels.~   "
149317|NCT01612000|"~     The purpose of this study is to investigate the safety and immunogenicity of a recombinant~     hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at~     3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA~     formulation.~   "
149318|NCT01611987|"~     Despite the benefits of exercise and physical activity people with Multiple Sclerosis (MS)~     are relatively inactive. Physical activity is important for persons with disabilities to~     maintain physical function. A lack of physical activity can contribute to heart disease,~     osteoporosis, obesity, and diabetes. At the moment, the best way for people with MS to~     exercise and be physical activity is unknown. People with MS report not knowing what to do.~     This is a barrier to exercise.~      The global aim of this study is to contribute evidence for the role of targeted exercise in~     altering MS outcomes over time. The design is a randomized controlled trial (RCT). The~     primary research question is to what extent does an MS Tailored Exercise Program (MSTEP)~     result in greater improvements in exercise capacity and related outcomes in comparison to a~     program based on general guidelines for exercise among people with MS who are sedentary and~     wish to engage in exercise as part of MS self-management. The primary outcome for this~     question is exercise capacity measured using cycle ergometry. However exercise efficiency,~     functional ambulation, strength, components of quality of life including frequency and~     intensity of fatigue symptoms, mood, global physical function, health perception, and illness~     intrusiveness, will also be measured as components of a global response outcome. The first~     confirmatory hypothesis is that MSTEP will result in a greater proportion of people making~     clinically relevant gains (at least 10% change) in exercise capacity than with general~     guidelines after 12 months of intervention; a secondary hypothesis is that, while there may~     be some decline in exercise capacity among individuals from end of intervention to follow-up~     one year later, the decline will be greater in the general guideline group augmenting the~     difference between groups in the proportion making 10% change from study entry to 24 months.~     In other words, gains will be maintained more for the MSTEP group over the general guideline~     group.~      An exploratory hypothesis is that more of the targeted outcomes will improve with the MSTEP~     program than the general guideline approach. An explanatory hypothesis is that these gains~     will be accompanied by reports of greater exercise enjoyment and exercise self-efficacy~     (confidence) with the MSTEP program than with the general guideline program leading to more~     consistent exercise engagement and improved long-term adherence.~   "
149319|NCT01611974|"~     This study will assess safety, antiviral activity, and pharmacokinetics of different doses of~     maribavir administered orally for up to 24 weeks for treatment of CMV infections that are~     resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in~     recipients of stem cell or solid organ transplants.~   "
149320|NCT01611961|"~     Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel~     developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was~     evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients~     with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects~     of DT-LM compared to commerical docetaxel.~   "
149321|NCT01611948|"~     Cannabis is the most widely used illicit drug in the United States, and worldwide, with 1 in~     10 users estimated to meet diagnostic criteria for cannabis dependence. Avoidance of~     withdrawal symptoms (e.g., disturbances in mood, sleep, and craving) is a common relapse~     precipitant. Cannabis use also impairs executive cognitive functions thereby increasing~     vulnerability to relapse and reducing the ability to benefit from behavioral therapy. There~     are no pharmacological treatments for cannabis dependence, despite the large number of~     afflicted individuals and the limitations of behavioral therapies which do not remediate~     withdrawal and are associated with high rates of treatment failure. The primary aim of this~     clinical trial is to evaluate the efficacy and safety of a novel neurokinin1 (NK1) receptor~     antagonist, aprepitant (Emend), (125mg/day), in outpatients with current cannabis dependence.~     The main hypothesis to be tested is to evaluate the relative efficacy of aprepitant 125 mg/d~     vs. placebo for reducing cannabis withdrawal symptoms in cannabis dependent outpatients,~     specifically anxiety, mood, craving and sleep.~   "
149322|NCT01611935|"~     Trauma patients, who are transfused with multiple blood products to treat shock due to blood~     loss, frequently develop inappropriately low vasopressin levels. Vasopressin is a hormone~     necessary to maintain an adequate blood pressure and low levels have been associated with the~     need for increased transfusions, vasopressors and additional morbidity. Vasopressin is~     routinely used in the ICU to treat septic shock and other disease processes resulting in~     decreased vasopressin levels and low blood pressure. This study will investigate the~     potential benefit of early vasopressin supplementation during the resuscitation of trauma~     patients and the applicability of using copeptin as a vasopressin biomarker. Trauma patients~     who receive 6 or more units of blood product within 12 hours of arrival will be randomized to~     receive a vasopressin bolus plus infusion or a similar volume of a placebo (normal saline)~     for 48 hours. Serial blood samples will be taken for 5 days post-injury. Clinical and~     demographic data will be recorded prospectively.~   "
149323|NCT01611922|"~     The purpose of this study is to assess eyelid margin staining, termed lid wiper~     epitheliopathy (LWE), in three populations. The hypothesis is LWE will be more prevalent in~     symptomatic contact lens wearers than non-symptomatic contact lens wearers and least~     prevalent in asymptomatic non-contact lens wearers.~   "
149348|NCT01611597|"~     Validation of a measure specifically suitable to evaluate the residual function of upper~     limbs of non-ambulant neuromuscular patients, especially with Duchenne muscular dystrophy and~     spinal muscular atrophy.~      This approach is of fundamental importance for clinical monitoring and preparing the future~     therapeutic trials.~   "
149324|NCT01611909|"~     This study aims to investigate the efficacy and safety of topical p-menthane-3,8-diol~     (PMD)-rich Corymbia Citriodora oil (Citriodiol®) in children with impetigo. Citriodiol® is~     already known to be effective as an insect repellent and is safe in its topical application.~     The investigators have also found in our laboratory that it is bactericidal against~     Staphylococcus aureus, the bacteria responsible for causing impetigo. Parents are always~     searching for a natural alternative to antibiotics (the current gold standard treatment for~     impetigo), and the investigators believe Citriodiol® could provide this possible alternative.~   "
149325|NCT01611896|"~     The purpose of this study is to investigate if selenium supplementation to the standard~     treatment with anti-thyroid drugs in patients with Graves' hyperthyroidism, will lead to a~     fewer people with anti-thyroid treatment failure and faster remission, in terms of better~     quality of life during the first year of treatment and more patients staying in remission.~   "
149326|NCT01611883|"~     This study will examine the effect of ezetimibe on glucose metabolism in participants with~     Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated~     hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the~     placebo control group.~   "
149327|NCT01611870|"~     The purpose of this study is to evaluate the performance of AVAPS AE therapy in COPD patients~     during nocturnal ventilation.~   "
149328|NCT01611857|"~     This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with~     advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in~     Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is~     hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this~     regimen.~   "
149329|NCT01611844|"~     The only test available for in vivo diagnosis of tuberculosis is the intradermal injection of~     tuberculin according to the Mantoux method (also named tuberculosis skin test or PPD skin~     test).~      The tuberculin skin test is based on a delayed-type hypersensitivity skin reaction However,~     this test needs to be performed by trained personnel, presents problem of reproducibility,~     and its interpretation is not well standardized (measure in millimeters of skin induration 48~     to 72 hours after the PPD skin test).~      The new generation BD micro needle used in this study should solve the technical~     difficulties; intradermal administration of tuberculin could then be made by any personnel.~      A non-invasive and objective instrumental method of reading the test will be also tested .~   "
149330|NCT01611831|"~     The main objective is to assess the efficacy of Acceptance & Commitment Therapy (ACT) in~     group for the treatment of fibromyalgia. The secondary aims are: 1.- To assess the~     cost-effectiveness of ACT and 2.- To assess the efficacy of ACT in other variables such as~     anxiety, depression, pain or global function. 3.- To evaluate the usefulness or~     electroencephalographic cordance as a prognostic variable of the treatment.~      HYPOTHESIS: ACT in group is effective for improvement of pain acceptance and other outcome~     variables (pain, anxiety, depression, global function) in fibromyalgia, and it is~     cost-effective. Cordance is an useful predictor of treatment efficacy in these patients.~      DESIGN: Multicentre, randomized, controlled study, with parallel groups, and a 6-month~     follow-up period. Participants will be randomly allocated to one of two conditions: 1.- Group~     Acceptation & Commitment Therapy or 2.- Treatment as usual by his general practitioner.~     Patients diagnosed of fibromyalgia, according to the American College of Rheumatology, will~     be recruited in primary care. Assuming an alpha=0.05 and p=80%, using two tails, and~     calculating 5% of refusals, it will be necessary a sample size of 55 patients for each group~     of patients.~   "
149331|NCT01611818|"~     BACKGROUND: Major depression will become the second most important cause of disability in~     2020. Computerised cognitive-behaviour therapy could be an efficacious and cost-effective~     option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided~     psychotherapy have been carried out.~      AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major~     depression in the Spanish health system.~      METHODS: The study is made up of 3 phases: 1.- Development of a computerised~     cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter~     controlled, randomized study: A sample (N=450 patients) with mild/moderate depression~     recruited in primary care. They should have internet availability at home, not receive any~     previous psychological treatment, and not suffer from any other severe somatic or~     psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity~     Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided~     Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI~     psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be~     also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume~     of health and social services). Patients will be assessed at baseline, 3 and 12 months. An~     intention to treat and a per protocol analysis will be performed.~   "
149332|NCT01611805|"~     This is an double-blind, single dose, four-period, crossover study in Japanese healthy male~     volunteers to assess the pharmacokinetics and safety/tolerability of single doses of~     GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg~     GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose~     ascending crossover design. Serial pharmacokinetic samples will be collected following each~     dose and safety assessments will be performed. The pharmacokinetics and dose proportionality~     of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and~     1000 mg under fasted conditions will be assessed. In addition, a comparison will be made~     between the pharmacokinetics of GSK1605786 under fed and fasted conditions.~   "
149345|NCT01611636|"~     The incidence and prevalence of the allergic, autoimmune and rheumatic diseases are different~     all over the world. The relative impact of gene and environment on diseases can be revealed~     by studies from different populations. National Health Insurance database in Taiwan provides~     a wealth of epidemiology study, which can contribute to the understanding of these diseases.~     However, national health care database did not contain test results and clinical details. The~     database of the hospital records can provide complimentary clinical details. Via the~     comparison of databases of the National health Institutes and the investigators hospital, the~     investigators hope that the characteristics and outcomes of these patients can be better~     understood.~   "
149346|NCT01611623|"~     Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an~     experimental drug that blocks Hsp90. It is being evaluated for safety in patients with~     cancer.~   "
149333|NCT01611792|"~     Low back pain affects 80% of Americans at some time during their lives. Although recovery~     usually occurs within 6 months, there is a 50% recurrence within one year's time. It has long~     been thought that poor control of trunk muscle may lead to abnormal forces across the spine,~     which then damage local spinal structures, thus, leading to low back pain. However, the~     investigators know little about the function of specific trunk muscles in healthy subjects~     during various activities of daily life. Furthermore, the precise muscle dysfunction~     associated with low back pain has not been well characterized at all. In addition, the~     investigators know little about which exercise protocol is most beneficial for particular~     subgroups of people with low back pain. Thus, the purposes of this study are to learn more~     about: 1) how trunk muscles are affected by low back pain; 2) which exercises might be most~     beneficial for people with certain kinds of low back pain; and 3) how these exercises~     influence trunk muscle function. By having a better understanding of which trunk muscles are~     affected by low back pain, rehabilitation specialists can design exercise programs and~     therapeutic interventions that are more specific and more effective.~   "
149334|NCT01611779|"~     The objective of this study is to assess the feasibility and safety of tongue suspension~     using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive~     sleep apnea (OSA).~   "
149335|NCT01611766|"~     The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and~     validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian~     cancer.~   "
149336|NCT01611753|"~     The purpose of this study was to evaluate the immediate effects of red blood cells~     transfusion on central venous oxygen saturation and lactate levels in septic shock patients~     randomized to two different hemoglobin levels.~      The influence of red blood cell (RBC) transfusion on the adequacy of oxygen delivery (DO2)~     and supply (VO2) could be assessed by systemic oxygen variables such as central venous oxygen~     saturation (ScvO2) and lactate levels. Although it is not clear that alterations in these~     parameters actually represent an improvement in the DO2/VO2 ratio, they might represent a~     better transfusion trigger than the absolute hemoglobin value.~      Patients admitted with a diagnosis of septic shock and hemoglobin levels lower than 9.0 g/dL~     , less than 48 hours of shock diagnosis, were included, a central venous catheter in the~     superior vena cava and signed informed consent. The investigators randomized all patients~     into two groups. Patients in the liberal group received transfusions immediately, as the~     objective was to maintain hemoglobin levels above 9.0 g/dL. In the restrictive group,~     transfusion was withheld until their hemoglobin levels fell below 7.0 g/dL.~      Each time a patient received a transfusion, the investigators collected a set of laboratory~     tests, including hemoglobin levels, ScvO2 and lactate, at two time points, immediately before~     transfusion and one hour after its ending.~      The sample size was calculated by considering that in 80% of the transfusions in patients in~     the restrictive group ScvO2 would improve compared to only 45% of those in the liberal group,~     with an alpha error of 0.05 and 80% power. Improvement was defined as an increase of 5% over~     the pre-transfusion ScvO2. Twenty-eight transfusions in each group would be necessary, but to~     correct for potential non-parametric distribution of the main variables, the number was~     adjusted to 35 transfusions in each group.~      Trends in ScvO2 and lactate were categorized as worsening or improving. The investigators~     defined improvement when ScvO2 reached 70% in patients with baseline levels below this~     threshold or when there was an absolute increase of at least 5% after transfusion. Any~     increase in patients with previous ScvO2 ≥ 70% was considered to be no change. Worsening~     was defined as a reduction of 5% in the previous levels or a decline to less than 70% in~     patients with pre-transfusion levels in the range of 70 to 75%. The investigators also~     carried out a ROC curve analysis to assess the accuracy of the pre-transfusion hemoglobin~     levels, pre-transfusion lactate and pre-transfusion ScvO2 in predicting the patients whose~     ScvO2 would increase more than 5% with transfusion. For this analysis, the investigators used~     a different approach because it would also be necessary to analyze patients with a lower~     chance of response to assess the prediction of response. Thus, this analysis included all~     patients with ScvO2 below 75%, rather than only those below 70%. As before, the investigators~     defined improvement as any increase ≥ 5%. The investigators did not consider patients with~     levels above 75% in this analysis, as the physiological interpretation of this situation is~     challenging. The investigators considered as altered any lactate levels above 1.5 times the~     reference level, and a change ≥ 10% was defined as improvement or worsening. In patients with~     baseline normal levels, the status was recorded as worsening if a 10% increase was detected.~     Afterwards, the investigators tested the association between these categorized variables and~     the baseline levels of hemoglobin. The impact on perfusion was also assessed by the~     determination of Δlactate (lactate post-transfusion x 100/lactate pre-transfusion) and ΔScvO2~     (ScvO2 post-transfusion x 100/ScvO2 pre-transfusion), and their correlation with the baseline~     hemoglobin levels was analyzed using the Spearman correlation test.~      In all tests, the results were considered significant if the p level was lower than 0.05.~   "
149337|NCT01611740|"~     Hospital-acquired infections are common complications in preterm infants. The diagnosis has~     to be fast and accurate. Indeed, the early identification of a suspected infection is very~     important, since the early administration of antibiotics lowers the risk of septic shock and~     improves long term outcome in the infected newborns who survive. Besides, a high specificity~     in the diagnosis of infection allows for the reduction of inappropriate treatment and thus~     prevents the emergence of antibiotic resistance.~      The aim of this study is to develop a computer-assisted diagnosis tool, based on the real~     time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of~     infection of the preterm infant, at the bedside.~   "
149338|NCT01611727|"~     Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical~     issue. There are emerging data which suggest that mutation carriers may respond differently~     than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary~     cancers for a range of pathologic and molecular factors, including tumor grade and histologic~     appearance. Several studies have shown that the response to treatment for women with a~     BRCA1-associated breast cancer reflects the underlying tumor biology, in particular, the~     impairment of the DNA damage response and repair pathways, and that it is possible to exploit~     the sensitivity of BRCA1-associated cancers to DNA damage.~      It is equally important that the investigators evaluate the benefit of cisplatin in women~     with disseminated breast cancer, including those who have previously been treated with one or~     more chemotherapy regimens. This study is undertaken to evaluate the efficacy of cisplatin~     chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary objective is to~     determine the objective response rate of cisplatin in BRCA1 carriers with metastatic breast~     cancer. The secondary objectives are to determine 3-year survival and to evaluate the~     toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.~   "
149339|NCT01611714|"~     This study will 1) Develop two interventions: a) an audit-feedback email intervention that~     provides clinicians with data on CT scan ordering practices by patient race; and b) a~     clinical decision support (CDS) message in the electronic medical record headache template;~     and 2) Compare the effectiveness of these 2 interventions in eliminating a previously~     observed Black-White disparity in CT scanning rates to rule out subarachnoid hemorrhage~     (SAH).~   "
149340|NCT01611701|"~     The aim of this prospective randomized double-blind study was to compare the efficacy and~     safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after~     failed first radiofrequency ablation.~   "
149341|NCT01611688|"~     This trial is conducted in Europe. The aim of this trial is to describe the safety and~     tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in~     subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.~   "
149342|NCT01611675|"~     This research study was intended to be a Phase I/II clinical trial, but the trial was~     terminated before the phase 1 portion was completed. Phase I clinical trials test the safety~     of an investigational combination of drugs. Phase I studies also try to define the~     appropriate dose of the investigational drug combination to use for the Phase II portion of~     the study, which will enroll more participants and continue to study the effects of the drug~     and the safest dose. Investigational means that the combination of vemurafenib and~     leflunomide is still being studied and that research doctors are trying to find out more~     about it. It also means that the FDA has not approved this drug combination for your type of~     cancer.~      Genes are a specific part of your cell materials which send code messages to determine what~     the investigators bodies look like, such as eye color, and instruct cells to control growth~     and development of the body. Researchers have found that a large number of melanoma cells~     have mutations in the BRAF gene. Normally, the BRAF gene helps to control how cells grow.~     Mutations in the BRAF gene may disrupt this control and allow cells in the skin to change~     into cancer cells, in which case, the cells keep dividing and growing out of control.~     Specifically, it has been shown that vemurafenib blocks the effects of these mutations in the~     BRAF gene, and, as a result, may help to prevent cancer growth. The FDA has approved~     vemurafenib for use in patients with BRAF mutation positive melanoma that is unable to be~     removed by surgery (unresectable) or that has spread (metastatic).~      Leflunomide is in a class of medications called disease-modifying antirheumatic drugs~     (DMARDs). It is FDA approved for the treatment of rheumatoid arthritis and it is believed to~     decrease inflammation in that setting. However it is not approved for treatment of melanoma.~     The researchers of this study believe this agent may help prevent cancer growth as well as~     enhance the properties of drugs that target the BRAF gene (such as vemurafenib) based on~     recently published laboratory research, and would like to learn more about any effects this~     combination may have on your disease.~      The main purposes of this study are to determine the highest dose of vemurafenib and~     leflunomide that can be given in combination without causing severe side effects, to see~     whether the combination of vemurafenib and leflunomide is safe in participants with BRAF~     mutant metastatic melanoma and to learn if the combination of vemurafenib and leflunomide~     shows any signs of effectively treating your disease.~   "
149343|NCT01611662|"~     The purpose of this research study is to find out what effects, good and/or bad, dose-dense~     (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given~     before surgery have on patients and their muscle invasive bladder cancer.~   "
149344|NCT01611649|"~     The objective of this study is to determine whether the use of a mix of dairy lipids and~     plant oils in infant formula can increase the sum of omega-3 fatty acids levels in membrane~     phospholipids of red blood cells (RBC) in 4 month-old infants compared with a formula~     containing only lipids of plant origin.~   "
149347|NCT01611610|"~     The aim of this project is to establish a network of clinical teams including the major~     neuromuscular centers in Europe.~      We plan to work together to find the best common outcome measures for the following~     multicenter therapeutic trials.~   "
149350|NCT01611571|"~     The purpose of this study is to develop new treatment options for osteoporosis in men. The~     Investigators will study two medications and three treatment regimens. First, risedronate~     (FDA approved) will be studied as monotherapy. Second, the investigators will study~     injectable parathyroid hormone (PTH 134, teriparatide; FDA approved), as a therapy for male~     osteoporosis. PTH, a naturally occurring hormone produced by the parathyroid glands, is one~     of the most important regulators of bone metabolism. The drug being studied in this protocol,~     teriparatide, is the first aminoterminal 34 amino acids of the native 84amino acid peptide.~     Teriparatide contains all of the classical biological activities of native PTH. In studies of~     postmenopausal women, in a small study of 23 men with osteoporosis and a larger study of 437~     men treatment with teriparatide led to significant increases in bone density. Although~     teriparatide and actonel are now approved for osteoporosis in men additional studies of these~     medications are needed in order to establish how best to use these drugs. This study is~     focused on an entirely new treatment approach, namely the combination of two medications for~     the treatment of osteoporosis risedronate with teriparatide to evaluate whether combination~     therapy is superior to therapy with either medication alone. This study is also designed to~     assess the extent to which risedronate maintains increases in bone density after a course of~     mono or combination therapy.~   "
149351|NCT01611558|"~     To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall~     response associated with ipilimumab treatment~   "
149352|NCT01611545|"~     The aim of this biospecimen repository is to evaluate an individual's genotype, identify the~     variances, and understand how they relate to treatment with clopidogrel.~   "
149353|NCT01611532|"~     Acute pancreatitis is a multi-system disease with an unpredictable clinical course and~     significant morbidity and mortality Approximately 20% of patients develop multi-organ failure~     requiring management within a critical care environment However much of the pathophysiology~     of the disease, particularly understanding why some patients develop life-threatening disease~     whilst others have a relatively benign course, remains unclear.~      It well recognised that intra-abdominal hypertension (IAH) is a cause for organ dysfunction~     in critically ill patients and is associated with higher morbidity and mortality rates~     (Sugrue et al., 1999). Abdominal compartment syndrome (defined as an increase in~     intra-abdominal pressure (IAP) >20mmHg) is associated with new organ failure (Malbrain et~     al., 2006). The mechanisms believed to contribute to IAH in acute pancreatitis include~     increased capillary permeability, hypoalbuminaemia and volume overload (third space~     losses), producing retroperitoneal and visceral oedema (Dambrauskas et al., 2009).~      Several small studies have recently described the link between intra-abdominal hypertension~     and adverse outcome in acute pancreatitis ( Dambrauskas et al., 2009; de Waele et al., 2005),~     however none of the authors appreciate the potential predictive value of there conclusions or~     the potential as a target for therapeutic intervention to alter the disease course.~      This study aims to study the natural history of intra-abdominal pressures in acute~     pancreatitis and determine whether they truly do have a predictive value or whether they are~     simply another marker of organ failure in a multi-system disease with notoriously poor~     outcome.~   "
149354|NCT01611519|"~     Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery~     with an epidural catheter in place?~   "
149355|NCT01611506|"~     RATIONALE: Radiotherapy is currently the most efficient way to induce pathologic responses,~     which are associated with a favorable prognosis in localized tumors. Novel radiotherapy~     techniques are associated with significantly less toxicity than traditional radiation~     protocols and permit to avoid the toxicity to adjacent organs. Established chemotherapy~     regimens, such as cisplatin and capecitabine, and monoclonal antibodies, such as cetuximab,~     can block tumor growth in different ways. Giving radiation therapy together with cisplatin~     and cetuximab before surgery aims to induce a pathological response and improve the prognosis~     after surgery.~      PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy~     when given together with cisplatin and cetuximab in treating patients who are undergoing~     surgery for locally advanced gastric cancer.~   "
149356|NCT01611493|"~     A potential complicating factor affecting implants is crestal bone loss. The causes of~     crestal bone loss are attributed to several factors. Among those hypothesized, proof for one~     or another cause remains obscure. Clinical documentation suggests that implant design may be~     a key factor. While the evidence is inconclusive, various authors suggest that it is a result~     of a combination of effects including (1) limited drilling procedure and restricted~     second-stage surgery 2, (2) rough implant surface in crestal bone 3, (3) microthread design~     for implant stiffness 4, (4) loading along a conus versus a flat interface 5, and (5) the~     absence of a significant microgap 6.~      The practice of platform switching (e.g. placing a 4 mm diameter abutment on a 5 mm implant~     seating surface physically moves the inflammatory cell infiltrate zone away from the crestal~     bone). The growing body of anecdotal platform switch evidence supports this biological width~     hypothesis. Here the biological width refers to the height of the dento-gingival attachment~     apparatus around a normal tooth and is defined as the distance necessary for a healthy~     existence of bone and soft tissue from the most apical extent of a dental restoration.~      To formally test this hypothesis the current study has been designed. The Prevail implant has~     been made with an integrated medialized seating surface that establishes a platform switching~     function. This implant moves the implant/abutment interface away from the crestal bone and~     may therefore reduce the amount of bone loss observed in the standard (non-medialized)~     Osseotite implant design. The objective of this study is to evaluate crestal bone levels~     adjacent to the implant reference point from the time of implant placement to a period of two~     years after loading.~   "
149357|NCT01611480|"~     The aim is to evaluate efficacy and safety of three different dosing regimens of Limtop in a~     study involving 96 patients with actinic keratosis on the head or face.~   "
149370|NCT01611311|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 409306 in healthy young and elderly male and female volunteers following oral~     administration of repeated rising doses, given once daily over 14 days to young healthy~     genotyped and elderly healthy male/female volunteers.~   "
149384|NCT01611129|"~     The purpose of this study is to determine whether the use of 'patient journey' model in~     internet-based counseling of a person with hearing impairment is a feasible approach in~     management of emotional and social consequences, anxiety and depression, readiness to change~     and acceptance of hearing loss.~   "
149358|NCT01611467|"~     Part 1: To characterize the biotransformation and excretion of CC-223 following a single~     20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in~     healthy male subjects; and to evaluate the tolerability of CC-223 after a single 20-mg oral~     dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male~     adult subjects Part 2: To evaluate the effect of a high-fat meal on the pharmacokinetics (PK)~     of CC-223 following a single 20-mg oral dose of CC-223 tablet; To evaluate the effect of a~     high-fat meal on the PK of M1, the principal pharmacologically-active metabolite, following a~     single 20-mg oral dose of CC-223 tablet; and to evaluate the tolerability of CC-223 after a~     single 20-mg oral dose of CC-223 tablet in healthy male adult subjects.~   "
149359|NCT01611454|"~     The PREFER II trial primary objective of the trial is to show how much radiation attenuation~     is provided by XPF thyroid collars in absolute and relative terms.~   "
149360|NCT01611441|"~     The main purpose of the study is to better understand how specific proteins/markers in blood,~     urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and~     joint tissue are involved in osteoarthritis of the knee. The aim is to investigate if there~     is a correlation between x-ray results, specific proteins/markers and different types of pain~     in patients with osteoarthritis of the knee. The study consists of 3 visits over 3-20 days~     and the last visit will be the day of surgery.~   "
149361|NCT01611428|"~     A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.~   "
149362|NCT01611415|"~     A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions~     between furosemide and ipragliflozin (ASP1941) in healthy volunteers.~   "
149363|NCT01611402|"~     Background:~      - Tuberculosis (TB) infection is particularly deadly when it happens in people who are also~     infected with the human immunodeficiency virus (HIV). However, not much is known about how~     these two infections affect each other. Some people who have HIV or TB infections develop~     health problems after they start taking either HIV or TB medications or both. These drugs can~     improve the body s ability to fight infections, but sometimes this sudden improvement can~     make the infected person initially become sicker. Researchers want to study how these~     infections affect the immune system and the gene expression of people who have TB and may or~     may not have HIV, to see if there is a pattern of gene expression that may predict whether~     people starting treatment may get sicker initially.~      Objectives:~      - To study the gene expression and immune systems of people with TB who may or may not also~     have HIV.~      Eligibility:~        -  Adults at least 18 years of age who have tuberculosis.~        -  Participants will be drawn from study sites in the United States and China.~      Design:~        -  Participants will be divided into three study groups. The first group will have TB but~          not HIV. The second group will have both TB and HIV that have not been treated. The~          third group will have both TB and HIV that are currently being treated.~        -  All participants will have a single study visit. Blood samples will be collected at this~          visit. A medical history will also be collected.~        -  No treatment will be provided as part of this study.~   "
149364|NCT01611389|"~     The aim of this study is to evaluate the effect of minimizing right ventricular pacing in~     dual-chamber pacemaker patients with sinus node disease (SND) and first degree~     atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure~     measures.~   "
149365|NCT01611376|"~     The investigators validated ICG's(impedance cardiography) usefulness during the abdominal~     surgery, by comparing it with FloTrac/Vigileo™ (Edwards Lifesciences,Irvine, CA, USA)~   "
149366|NCT01611363|"~     In this study the effect of ipragliflozin on glucose homeostasis in healthy subjects and T2DM~     subjects, and the effect of exposure of ipragliflozin on urinary glucose excretion and plasma~     glucose in T2DM subjects will be investigated.~   "
149367|NCT01611350|"~     The purpose of this study is to determine the effectiveness of different sales offers and~     different marketing messages to increase the uptake of energy efficient cookstoves.~      This research will address the following major barriers to the acquisition and correct use of~     improved cookstoves into four main categories:~        -  Inappropriate product or marketing for intended users~        -  Lack of consumer trust in new products~        -  Failure to address consumers' financial constraints~        -  Failure to achieve behavioral change~      To do so this research includes 3 Randomized Controlled Trials including:RCT 1- Testing the~     Effectiveness of Marketing Messages in Increasing Willingness to Pay; RCT 2- Testing the~     Effectiveness of the Novel Sales Offer and its ability to Increase Uptake of Purchasing~     Energy Efficient Cookstoves; and RCT 3-Measure the Effects of Fuel Efficient Cookstoves on~     Health, Fuel Use and Time Spent Collecting Fuel.~      RCT 1 studies the price women are willing to pay for the improved stove. It will also test~     the effects of the two most effective marketing messages identified during the Phase 1~     Feasibility stage (e.g., improved health, saves time, and has high status) on increasing~     willingness to pay. RCT 1 will run second price auctions in 36 parishes with an average of 60~     participants per meeting.~      From RCT 1, RCT 2 tests the effect of a Novel Sales Offer- which includes a free trial, and~     time payments- on purchasing decisions of participants versus those that receive the~     Traditional Offer- a cash and carry offer. Based on a pilot in urban Kampala conducted by Dr.~     David I. Levine (co-P.I. on this project) results show a 44% uptake for households offered~     the novel offer vs. a 4% uptake for those offered the traditional offer. The hypothesis is a~     novel offer will significantly increase uptake of fuel efficient cookstoves in rural Uganda~     when compared to a traditional offer.~      RCT 3 measures the impacts of fuel efficient cookstoves on health, fuel usage, and time spent~     collecting fuel. For RCT 3 we will randomize those who accept the Novel Offer into early and~     late groups. To measure the impacts of improved stoves on health, fuel use, time spent~     collecting fuel, etc., there will be a baseline and follow-up survey and associated~     quantitative measures on our full sample and a small endline on select quantitative measures~     for a sub-sample.~   "
149368|NCT01611337|"~     Therapeutic alliance, and drug observance are major difficulties in the care of persons~     presenting schizophrenic symptomatology. They appear to be linked to insight, the~     consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it,~     but usually without using specific evaluation tool. Insight is usually not evaluated during~     care, and its evolution is also not known, although it is highly probable that a positive~     evolution of insight for a person in hospital correlated to an adapted and optimal care by~     the medical and nursing teams. The investigators do not know examples of insight evaluation~     during a sequence of hospital care, or any evidence of insight variation in relation to~     evolution abilities of some schizophrenic patients cared in hospital.~      The investigators propose here to evaluate insight in people presenting schizophrenia or~     related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better~     characterize insight variations, and identify the sociodemographic, clinical and therapeutic~     variables linked to it.~   "
149369|NCT01611324|"~     The purpose of this study is to assess if a dilution with 1.4% sodium bicarbonate of a 2%~     mepivacaine+epinephrine solution, can be effective in reducing the pain associated with local~     infiltration anesthesia, during ambulatory phlebectomy procedures.~   "
162558|NCT01438099|"~     This study wants to investigate if ultrasound assisted epidural catheter insertion for labor~     analgesia is easier and safer to the standard epidural technique.~   "
149371|NCT01611298|"~     This research study is for subjects that are receiving a bone marrow transplant. As part of~     the transplant subjects will receive stem cells from a donor who has agreed to donate stem~     cells for them. Unfortunately, it takes a long time for the immune system to recover after a~     bone marrow transplant. This makes it more likely for patients to develop serious infections.~      This study is being done to better understand how the immune system will recover after~     transplant. The immune system includes the cells that help fight infection. This study will~     help investigators understand which patients are at risk for developing infections after~     transplant.~      All children and adults receive standard vaccines (shots) during their lifetime to provide~     protection from many different infections. One such infection is tetanus, a bacteria that can~     cause life-threatening problems. After transplant patients no longer have protection from~     infections such as tetanus. Therefore, most patients need to receive all their vaccine~     (shots) again after transplant. This is usually done 1-2 years after transplant, since it may~     take that long for patients to have a normal immune system.~      However, the investigators believe that the time it will take for the patient to develop~     normal protection against tetanus can be shortened if both the patient and the patient's stem~     cell donor receive a tetanus vaccine.~      The goal of this study is to determine if giving a tetanus vaccine to the donor and the~     patient will provide the patient with enough protection (immunity) to prevent infection~     following bone marrow transplant.~   "
149372|NCT01611285|"~     Within the general objective of investigating optimal medical techniques for pelvic prolapse~     repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more~     cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision~     analysis as the comparative strategy~   "
149373|NCT01611272|"~     To identify the following items through the post marketing surveillance under routine~     clinical practice after marketing authorization of Brilinta Tablet: the occurrence of~     unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events~     (AEs), the factors that may influence safety and efficacy of the drug.~   "
149374|NCT01611259|"~     This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus~     Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated~     Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.~   "
149375|NCT01611246|"~     The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the~     Acclarent Iontophoresis System with Earset (IPSES).~   "
149376|NCT01611233|"~     DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a~     higher than expected revision rate reported in the England/Wales and Australian national~     joint registries. There are two types of ASR hip implants used for total hip replacement~     surgery:~        -  ASR XL Hip System~        -  ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the~          study sponsor. MGH is conducting this study with the help of funding from DePuy~          Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects~          around the world. The countries include the United States of America, Australia, South~          Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test~          results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH will~          analyze the data annually for 6 years.~      The purpose of this study is to follow patients who have the ASR hip system for the next 6~     years. The findings of this study may help surgeons to make better informed decisions about~     monitoring and treatment of patients with ASR hip systems.~   "
149377|NCT01611220|"~     Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to~     a healthy level, but high percentage of patients relapse during the first year following the~     discharge. The development of strategies to overcome this problem represents a priority for~     clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program~     based on cognitive dissonance theory developed for hospitalized patients.~   "
149378|NCT01611207|"~     The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or~     Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic~     Subcutaneous Abdominal Wound healing-impairments (ISAW).~   "
149379|NCT01611194|"~     Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy~     for persistent post-concussive symptoms after mild tramatic brain injury~   "
149380|NCT01611181|"~     Hemoboost is a registered natural product containing specially processed haemolysed~     haemoglobin and iron dextran. It is marketed for human use on the basis of many years' use~     and documented effect in veterinary medicine. Iron dextran was introduced for use in human~     medicine in 1954.~      Krauterblut is a registered natural product made from a number of herbs where the active~     substance is ferrous gluconate. Both drugs have been available for a number of years and have~     become increasingly popular among patients and healthcare staff due to a reduction in adverse~     effects.~      The objective of this study is to determine the effect and adverse effects of the natural~     products Hemoboost and Kräuterblut compared with the usually administered ferrous sulphate in~     knee arthroplasty.~   "
149381|NCT01611168|"~     The proposed research study aims to determine whether applying the University of Pittsburgh~     Medical Center Nurse-Directed Diabetes Management Protocols (NDMPs) leads to improved~     clinical outcome and process measures as recommended by American Diabetes Association (ADA),~     quality of life, treatment satisfaction and medication adherence for adults with diabetes,~     and favorable providers' satisfaction as compared to usual diabetes care. Furthermore, the~     cost-effectiveness of performing the NDMPs compared to usual diabetes care in primary care~     settings will also be assessed.~   "
149382|NCT01611155|"~     You are being asked to take part in this research study because you are going to be treated~     with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes~     neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the~     effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on~     oxaliplatin-induced neuropathy (numbing, tingling and/or pain)~   "
149383|NCT01611142|"~     The primary objective of this study is to determine the overall response rate of KW-0761 for~     the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the~     receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are~     considered to play a role both in the recruitment of immune and inflammatory cells for~     anti-tumor response and in the selective homing of neoplastic B and T cells.~   "
149385|NCT01611116|"~     Standard chemotherapy is capable of eliminating most leukemic blasts in acute myeloblastic~     leukemia (AML), while leukemia-initiating cells are not sufficiently eradicated. As a~     consequence, refractory disease and relapse frequently occur in AML, especially in elderly~     patients. The investigators propose that the addition of temsirolimus may improve standard~     AML chemotherapy. Furthermore, temsirolimus may specifically target the leukemia-initiating~     cells in AML, thereby reducing the risk of leukemia relapse.~      The study's main part is preceded by a open label run-in part, in which optimal temsirolimus~     dose and schedule for the main part o the study will be determined.~   "
149386|NCT01611103|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities. In this research, a 9 volt battery is used to~     deliver very weak electrical current to the surface of the scalp while participants complete~     cognitive tasks. Our aim is to find out whether tDCS will improve task performance in adults~     over the age of 55.~   "
149387|NCT01611090|"~     The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in~     combination with bendamustine and rituximab in patients with relapsed or refractory chronic~     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).~   "
149388|NCT01611077|"~     The investigators want to find out if a treatment with a new combination of two different~     antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately~     elevated blood pressure is more effective than treatment with just one substance~     (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve~     comparable baseline conditions. Treatment is then started with the single substance. After~     six weeks, therapy is changed to another single substance and after a further six weeks, to~     the fixed combination tablet. Blood pressure is determined by office measurements taken by~     the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may be~     male or female and must be over 18 years of age.~   "
149389|NCT01611064|"~     Hand surgery requires a reduced blood flow to the hand during the operation, which is~     achieved using a tourniquet (tightly inflated circumferential cuff) around the upper arm.~     However this tourniquet is painful. This study investigates whether breathing oxygen can~     reduce the pain associated with the tourniquet to both improve patient experience and~     potentially to allow longer operations to be completed under a local anaesthetic (rather than~     a general anaesthetic, where the patient is put to sleep, which is more costly, time~     consuming and risky for the patient).~   "
149390|NCT01611051|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was~     independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2~     trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma~     half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to~     determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia~     following chemotherapy in patients with breast cancer.~   "
149391|NCT01611038|"~     The primary objective of this study is to determine if vitamin supplementation with a~     naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine)~     can restore disruption of circadian rhythm in shift workers.~   "
149392|NCT01611025|"~     This is a retrospective, multicentre, observational study to assess the trends in antibiotic~     utilization and hospital ecology with respect to susceptibility patterns of selected~     bacterial isolates to the utilized antibiotics.~   "
149393|NCT01611012|"~     The purpose of this study is to determine the type and degree of inflammatory parameters in~     peripheral blood of asthma patients compared to analysis of induced sputum.~      115 asthma patients visiting the outpatient clinic of the University Medical Center will be~     included. Blood samples are obtained and sputum induction is performed.~      Hypothesis: in asthma the analysis of type and degree of inflammation in peripheral blood by~     changes in phenotypes of leukocytes is at least as reliable as analysis of cells obtained~     from induced sputum~   "
149394|NCT01610999|"~     In order to keep our immune systems healthy over our lifetime, certain cells in the bone~     marrow and lymph nodes called stromal cells nurture the immune cells and protect them from~     damage. Stromal cells and blood cells communicate using a protein called SDF1a. The~     investigators think that cancer cells including lymphoma and multiple myeloma can trick the~     stromal cells into helping them avoid damage from chemotherapy by using SDF1a.~      Plerixafor is a drug developed to block the effects of SDF1a and has been approved by the~     Federal Drug Administration (FDA) for use in humans to help release blood stem cells from the~     bone marrow for use in transplantation. The use of plerixafor to interrupt communication~     between stromal cells and cancer has not been approved by the FDA and is experimental.~   "
149395|NCT01610986|"~     The purpose of this study is to determine whether glucose-fructose intake during training~     increases lactate transport and oxidation and improve endurance performance.~   "
149396|NCT01610973|"~     The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front~     of the eye.~      When the eye becomes opaque, the eye is not seeing and the only way to restore the visual~     acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). In~     half the cases the opacification of the cornea is secondary to dysfunction of the~     endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of~     regulating the moisture of the corneal thickness and therefore its transparency.~      While the total corneal transplantation has long been the only intervention for these~     diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called~     endothelial transplant or graft lamellar later. This intervention is now experiencing~     significant success as it reduces very significantly the incidence of complications found~     after transplantation of total cornea and the visual recovery period. This type of transplant~     is still difficult to achieve and the best technique is not yet established.~      Indeed, posterior lamellar transplantation of the cornea may be done manually or using an~     automated device. Manual techniques allow the preparation of grafts extremely thin but are~     difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may~     be less efficient in visual recovery.~      The aim of this project is to conduct a prospective study in order to compare these two~     techniques in terms of postoperative visual recovery and the vitality of the graft during the~     first year. To date, there is no such study.~      The department of Ophthalmology in the University Hospital of Rouen is one of the most famous~     French teams in the field of cornea transplants and receives many patients from different~     French regions. The recruitment of 40 patients needed to study should be done without great~     difficulty over a period of 18 months.~   "
149635|NCT01607853|"~     The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied~     then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20~     minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24~     hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ~     Dumas and JR Scholtz.~   "
149397|NCT01610960|"~     Noninvasive ventilation (NIV) is a well established, safe, and effective technique in~     improving gas exchange while reducing dyspnea and inspiratory effort in patients with either~     hypoxemic and hypercapnic acute respiratory failure (ARF) and averts the risk secondary to~     endotracheal intubation.Crucial factors for NIV success, in any forms of respiratory failure,~     are the tolerance to the interface used and the ability of the interface to unload~     inspiratory-muscle. Helmet is better tolerated over time, allowing continuous application of~     NIV for longer periods, while face mask has been proved to be more efficient at iso-support~     in unloading the respiratory muscles and improving patient-ventilator synchrony. Helmet NEXT~     (CaStar, NIV model, Starmed, Mirandola, Italy) is a novel type of helmet with a better~     compliant wall, that avoid the use of armpit braces potentially improving, compared to the~     standard helmet, both pressurization and patient-ventilator interaction and tolerance. The~     objective of this study is to compare the effects of NIV delivered via face mask, standard~     helmet, and NEXT helmet in terms of work of breathing, patient-ventilator interaction, and~     comfort.~   "
149398|NCT01610947|"~     Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or~     infliximab), and in stable low disease activity for at least 6 months, will be randomized~     into 2 groups: either keeping on their usual treatment with stable doses or progressive~     spacing of injections of their treatment. Follow-up will be done every 3 months during 12~     months, with regular monitoring of disease activity and, in patients from the group~     spacing, modification of the rhythm of injections according to health state and predefined~     protocol.~   "
149399|NCT01610934|"~     The purpose of this study is to evaluate the treatment potential of GLP-1-analogues in~     patients with Maturity Onset Diabetes of the Young (MODY) compared to common treatment.~   "
149400|NCT01610921|"~     Asthma is a frequently occurring inflammatory lung disease that affects the whole bronchial~     tree including the small airways (<2mm). Since the introduction of the solution~     hydrofluoroalkane (HFA) technology it is possible to generate medication with small particles~     of approximately 1-2 μm, and therefore to reach the small airways. However, at this moment~     the investigators have no reliable instruments to identify the asthmatic subjects who~     particularly benefit from treatment with inhaled small particles. Recently the investigators~     research group investigated whether provocation with small and large particles AMP is able to~     identify responders and non-responders to treatment with small and large particles of inhaled~     corticosteroids. This provocation technique gave promising results but needs further~     optimization.~      The aim of this study is to determine the optimal particle size of dry powder adenosine to~     assess small airway involvement in asthma. Secondary, to provide insight in the associations~     between the standard test, executed with nebulized AMP, and the new test, executed with dry~     powder Adenosine.~   "
149401|NCT01610908|"~     The primary aim of this multicenter randomized controlled trial is to compare the effect of a~     6 month Schroth exercise program combined with standard-of-care to standard-of-care alone~     on scoliosis curve severity measured using the Cobb angle.~      Secondary aims include:~        1. To determine the effect of Schroth exercises at 6 months on secondary outcomes including~          quality-of-life, spinal appearance, objective posture and spinal muscle endurance~          measurements.~        2. To determine the efficacy of 6 months of Schroth therapy offered to control participants~          after completing 6 months in the standard-of care group (using subjects as their own~          controls)~        3. To determine if the effects of the 6 months supervised Schroth exercise program can be~          maintained after supervised therapy is terminated.~      At Hopital Ste-Justine, the following secondary aims will be pursued to examine the~     preliminary evidence about the effect of Global Postural Re-education (to satisfy the local~     ethics committee request because Global Postural Re-education exercises were offered~     routinely to patients at that institution prior to the trial).~      A. To compare the effect and to quantify the treatment effect sizes of 6 months of Global~     Postural Re-education exercises with North American standard Care consisting of only~     observation and bracing to Schroth exercises combined with North American standard care~     and to North American standard care alone on scoliosis curve severity measured using the~     Cobb angle.~      B. To estimate the effect and quantify the treatment effect sizes of 6 months of Global~     Postural Re-education exercises with North American standard Care to Schroth exercises~     combined with North American standard care and to North American standard care alone on~     outcomes including quality-of-life, perceived spinal appearance, objective posture and spinal~     muscle endurance measurements.~      C. To determine if the effects of Global Postural Re-education exercises with North American~     standard Care can be maintained after discontinuing supervision.~      D. To estimate the feasibility of conducting a randomized trial focused on Global Postural~     Re-education exercises by quantifying enrollment rates, attendance at scheduled exercise~     sessions and compliance with the home exercises prescribed.~   "
149402|NCT01610895|"~     The objective of the study is to examine the effect of adding a strict low-residue lunch on~     the day before colonoscopy has on clinical efficacy and patient tolerability of bowel~     preparation, with patients receiving split-dose Polyethylene Glycol Based Lavage.~      The primary outcomes will be 1) quality of preparation in cleansing the colon and 2) patient~     satisfaction~   "
149403|NCT01610882|"~     This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's~     recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps~     determine what medication they need. Traditionally, this involves asking the child to rate~     their pain on a scale from 1 to 10, by moving a slider along a coloured scale or pointing to~     one of a series of faces on a piece of card. The Panda uses the same methods, but presents~     them on a smartphone screen. Our evaluation will ensure that the Panda gives the same pain~     scores as the traditional methods.~   "
149404|NCT01610869|"~     The primary objective is to explore the efficacy and safety of an all oral combination of~     BIBF 1120 (an inhibitor of angiogenic signalling) and metronomic cyclophosphamide in patients~     with multiply-relapsed advanced ovarian cancer, who have completed a minimum of two lines of~     previous chemotherapy and who for any reason are not suitable for further 'standard'~     intravenous chemotherapy treatments.~   "
149405|NCT01610856|"~     Proper bowel cleansing prior is an essential requirement for the conduct of colonoscopy.~     However, due to the nature of cleansing process, the ideal bowel cleansing preparation~     remains elusive.~      The objective of this study is to compare the efficacy, safety and tolerability of oral~     polyethylene glycol lavage given either as a single dose or split dose. The study will be a~     randomized controlled single blind two group study. The primary study outcomes will be the~     previously validated Ottawa bowel preparation score.~   "
149464|NCT01610076|"~     This is a single-center, randomized control trial of a code status video as an educational~     tool in the intensive care unit. Subjects are stratified by patient or surrogate and are~     randomized to either watch an educational video on code status or not watch the video. They~     are then asked knowledge base questions regarding code status as well as questions pertaining~     to comfort regarding code status. Participants randomized to watch the video are also asked~     questions related to acceptance of the video.~   "
149465|NCT01610063|"~     This was a study of a genotyping tool that reported on how subjects responded to medications~     and could be used in a community psychiatry practice to improve medication choice for~     depression. After the DNA test, an interpretive report was provided to the subjects'~     physicians. The hypothesis of this pilot study was that it was feasible to use this~     pharmacogenomic algorithm in a new setting to treat depressed subjects..~   "
149406|NCT01610843|"~     The aim of this study is to collect information about the clinical course and characteristics~     of sarcoidosis patients around the world through web-based surveys. Recruitment is directed~     at and driven by patients in the sarcoidosis community. This will allow the the investigators~     to study sarcoidosis patients across all demographic, geographic, and socioeconomic~     boundaries, not just patients seen at large research centers. The investigators believe this~     study can give investigators a broader and less biased view of sarcoidosis. The investigators~     would also like to collect genetic samples on this population to assess genetic variance in~     different phenotypes.~      The information for the study would be provided through a web based survey system that can be~     accessed by patients or physicians of patients from any computer with Internet access. This~     system would collect clinical information in sufficient detail so that the phenotype of~     individual patients can be evaluated. Upon agreeing to participate in further research~     studies through the website, subjects will also have the opportunity to provide a DNA sample.~   "
149407|NCT01610830|"~     Henoch Schonlein Purpura (HSP), vasculitis of small vessels with deposits of IgA, is~     considered by many authors as the systemic form of Berger's disease (IgA-N). IgA-N is~     characterized by IgA1 deposits in mesangial areas associated with mesangial proliferation.~     These two diseases remain the leading cause of ESRD by primitive glomerulopathy in Western~     countries. In recent years, considerable progress has been made in understanding the~     pathophysiological mechanisms of IgA-N. However, only a high rate of proteinuria at one year~     or the presence of severe glomerular inflammation on renal biopsy remain predictors of long~     term renal function. Moreover, the high variability of HSP clinical expression, from few~     purpura skin lesions that evolve favourably spontaneously, to rapidly progressive renal~     failure, remains so far unexplained but suggests the existence of individual genetic~     susceptibility.~      In the first part of the study, we will study key factors based on physiopathological data~     obtained by our laboratory as well as by other groups. The second part of the study concerns~     genetic factors. Although the candidate genes that may confer a particular susceptibility to~     the disease, to progress to ESRD or respond to treatment are many, the genes involved in~     inflammation or controlling renin-angiotensin system are of particular interest.~      We will apply these results by studying patients with HSP showing three distinct phenotypes~     (HSP with isolated cutaneous purpura or associated with minimal or severe renal disease) at~     diagnosis and after clinical remission.~      The purpose of this study is to assess whether the phenotype at diagnosis is associated with~     the physiological markers and if one of them predicts a pejorative evolution of renal disease~     at 1 year. Meanwhile, study of polymorphism of selected genes of interest could allow~     identification of patients with specific genetic susceptibility or with bad prognosis factors~     who would be thus eligible for specific treatment.~   "
149408|NCT01610817|"~     Adverse drug events (ADEs) are responsible for 3.6% of the hospitalisations in France. 50% of~     these ADEs could be preventable. Cardiovascular drugs are frequently involved in ADEs. A~     common underlying factor of such events is inadequate communication between patients and~     medical personnel. General practitioners (GP) often initiate the treatment of hypertension,~     being generally the first prescribers of these medications. 12.6% of the patients present an~     ADE with hypertensive drug after 3 months. The InPAct procedure is a tool to facilitate~     communication in order to improve patient safety in primary care. In the context of the~     primary care prescription of an antihypertensive drug, the GP informs the patient about~     hypertension, cardiovascular risk, and the benefits and risks of antihypertensive drugs,~     which helps the patient to detect and declare situations involving a heightened risk of~     antihypertensive-related ADEs. The aim of the InPAct study is to evaluate the efficiency of~     the InPAct intervention in primary care.~   "
149409|NCT01610804|"~     The purpose of this study is to determine changes in choroidal thickness in patients with~     Central Serous Chorioretinopathy (CSCR) during the first 3 months after initial diagnosis via~     Enhanced-Depth-Imaging-Spectral-Domain-Optical-Coherence-Tomography (EDI-OCT).~      Study hypothesis: Since exudative changes in the choroid seem to constitute the primary~     pathology of CSCR, changes in choroidal thickness compared to healthy eyes should be present~     and be visible using EDI-OCT.~   "
149410|NCT01610791|"~     This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra~     (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an~     inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive~     RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6~     infusions).~   "
149411|NCT01610778|"~     This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2~     diabetes on medication.~   "
149412|NCT01610765|"~     This study is to identify if a Novel Antiviral Drug could be used to treat babies with Herpes~     Simplex Virus (HSV) with central nervous system (CNS) disease. In this study the~     investigators will identify the best dose for young children as well as identify additional~     safety information about the Novel Antiviral Drug.~   "
149413|NCT01610752|"~     The purpose of this study is to determine how to help manage weight gain during pregnancy.~     This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in~     expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in~     overweight and obese pregnant women.~   "
149414|NCT01610739|"~     This study aims to examine the effect of carpal tunnel release on blood flow to the median~     nerve using SPY scope imaging to view the perfusion to the nerve.~   "
149415|NCT01610726|"~     The purpose of this study is to evaluate the health cost and clinical outcome by introducing~     enhanced recovery (ERAS) compared to conventional recovery in colorectal surgery.~   "
149416|NCT01610713|"~     An open-label extension study in which patients with multiple sclerosis received GW-1000-02~     [named Sativex® in Canada and also named Sativex® Oromucosal Spray] for four weeks in an~     open-label manner.~   "
149417|NCT01610700|"~     A study to compare the efficacy of GW-1000-02 [named Sativex® in Canada and also named~     Sativex® Oromucosal Spray] with placebo in relieving five key symptoms of Multiple Sclerosis~     after six weeks of therapy.~   "
149418|NCT01610687|"~     An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02~     treatment in multiple sclerosis.~   "
149466|NCT01610050|"~     This study will evaluate safety and tolerability to determine the MTD/RD.~   "
149467|NCT01610037|"~     The study will assess the long-term safety of the fixed combination product QVA149 versus~     placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary~     Disease (COPD) patients with moderate to severe airflow limitation.~   "
149468|NCT01610024|"~     Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung~     disease.~      Using the already established pulmonary rehabilitation model, we aim to split the group of 8~     into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on~     alternate (differing) weeks to see if it improves their overall exercise tolerance.~   "
149419|NCT01610674|"~     OBJECTIVE/RESEARCH QUESTION Optimising glycaemic control during hospital stay reduces rate of~     infections, length of stay and mortality,in particular in surgical patients. In guidelines~     and literature recommendations on optimal perioperative diabetes care are described.~     Nevertheless, in daily practice, perioperative glycaemic control is very often not achieved.~     This study aims at developing an implementation strategy that is tested on feasibility to~     improve perioperative diabetes care in terms of effectiveness, experiences and costs.~      DESIGN/OUTCOME MEASURES/IMPLEMENTATION STRATEGY A step-wise implementation model is applied:~     1) recommendations on optimal perioperative diabetes care (e.g. the administration of~     intravenous insulin, encouragement of diabetes self-management) are systematically translated~     into quality indicators; 2a) using these quality indicators, current care is measured by~     performing a medical record search among 400 patients in 6 hospitals; 2b) barriers and~     facilitators for optimal care are measured by performing interviews with professionals and,~     e.g. regarding self-management, with patients; 3) based on this information an implementation~     strategy is developed;4) implementation activities are enacted and 5) evaluated in a~     controlled before-after design in 6 hospitals providing before and after intervention 400~     patients.~      DATA ANALYSIS To obtain an indication of the effectiveness of the strategy, baseline and post~     intervention outcomes of intervention hospitals are compared with outcomes in control~     hospitals, using the quality indicators. Experiences of participants in the intervention~     hospitals will be measured to, if necessary, adapt the strategy to make it more effective and~     acceptable.~      ECONOMIC EVALUATION A cost analysis of the implementation strategy will take place.~     Implementation costs will be related to the difference in percentage of patients treated as~     described in the quality indicators before and after implementation. Information on the costs~     and effects at the patient level will also be compared before and after the implementation of~     the recommendations on optimal care.~   "
149420|NCT01610661|"~     The aim of this study is to determine the effect of habituation to diets with different types~     of carbohydrate (simple-carb, refined-carb, unrefined-carb) on selected Cardiovascular~     Disease (CVD) risk indicators.~   "
149421|NCT01610648|"~     The study is being conducted to test the ability of a simple questionnaire to detect mild,~     moderate or severe obstructive sleep apnea. The investigators are also investigating whether~     adding the size of the neck and waist can add to the accuracy of the questionnaire.~      The study will be conducted at the Center for Sleep Medicine at Tufts Medical Center. The~     investigators hope to enroll 250 patients in our study at Tufts Medical Center.~   "
149422|NCT01610635|"~     It is hypothesised that the number of donations made by English blood donors will be greater~     with reduced vs. standard inter-donation intervals. The null hypothesis is that there will be~     no difference in donations between treatment groups; this may arise if reduced inter-donation~     intervals result in a greater number of donation deferrals (due to low haemoglobin) and/or an~     unacceptable burden to donors.~   "
149423|NCT01610622|"~     Presently there is no apparatus, clinically available, for routine determination of cardiac~     output (CO) in children. The goal of this research is to develop new technology that will~     help determine CO in neonates.~   "
149424|NCT01610609|"~     Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by~     race and low socioeconomic status. Statins have been shown to decrease the risk of~     cardiovascular events among individuals with high CVD risk. Yet, despite increased statin use~     and overall declining CVD rates, disparities in statin use and disparities in the control of~     high cholesterol by race, ethnicity, and socioeconomic status have persisted.~      Objective: To improve the appropriate use of statins for primary cardiovascular disease~     prevention among high risk individuals at community health centers through a system of~     population health management that uses electronic health record (EHR) data to identify~     patients for targeted education and outreach.~      Aim 1: Conduct a randomized controlled trial among individuals with 10-year risk for~     myocardial infarction or coronary death of 10% or higher to determine if the population~     health management intervention, compared to usual care, results in higher rates of documented~     statin treatment discussions within 6 months (primary process outcome), higher rates of~     statin prescribing within 6 months (secondary process outcome), and higher rates of~     significant low-density lipoprotein cholesterol (LDL-C) lowering defined as a follow up LDL-C~     ≥30 mg/dL lower than baseline (primary clinical outcome).~      Aim 2: Interview patients who received the intervention to identify barriers to success~      Aim 3: Assess the overall costs of the intervention and the costs per each patient who~     achieves significant LDL-C lowering compared to patient who received usual care.~   "
149425|NCT01610596|"~     This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to~     determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied~     twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible~     subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or~     Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed~     50 grams.~   "
149426|NCT01610583|"~     Background:~        -  Health literacy means being able to understand basic health care information. This~          information can include drug labels and prescription instructions. It can also include~          doctor s instructions. Better health literacy can help improve a person s health~          outcomes.~        -  Many minorities have low health literacy. Latinos in particular have both low health~          literacy and poor health outcomes. Language barriers such as poor reading skills can~          contribute to problems with health literacy. Researchers want to develop a new health~          literacy measuring tool. This tool will focus on genetic literacy, which involves~          understanding personal risk of health problems. The tool will be written in Spanish. The~          study will work with Spanish-speaking Latinos to develop and test this genetic literacy~          tool.~      Objectives:~      - To develop a Spanish-language tool to study genetic literacy.~      Eligibility:~      - Spanish-speaking Latino adults between 18 and 75 years of age.~      Design:~        -  Participants will be screened with a brief interview. No personal samples will be~          needed.~        -  Participants will complete the genetic literacy questionnaire. It will be given in~          Spanish.~        -  The tool will ask about participants personal and family health history. It will also~          ask about their understanding of genetic terms and genetic testing. Other personal~          information, such as level of education, will be collected.~        -  Participants will receive a gift card for completing the survey.~        -  No treatment or genetic counseling will be provided as part of this study.~   "
149481|NCT01609855|"~     The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at~     time of caecal intubation, increases the adenoma detection rate.~   "
149482|NCT01609842|"~     Percutaneous coronary intervention (PCI) is a common invasive cardiovascular procedure~     performed in the VA with over 13,000 procedures in FY10. Clopidogrel is a critical adjuvant~     therapy following PCI with stent placement and is generally recommended for up to 1 year~     following the procedure. Despite the evidence supporting clopidogrel use, studies both~     outside and within the VA suggest that poor adherence to clopidogrel is common. However,~     prior interventions targeting non-adherence have not specifically focused on clopidogrel~     adherence among PCI patients.~      There are many potential reasons for early clopidogrel discontinuation that involve patient~     and healthcare system factors. Patients reported the following reasons for discontinuing~     clopidogrel within 1 month after drug-eluting stent (DES) implantation: 1) misunderstanding~     the intended treatment duration; 2) conflicting recommendations about intended duration; 3)~     cost of the medication; and 4) patients' own decision to stop. In contrast, patients who~     continued to take clopidogrel reported the following as helpful: 1) communication such as~     letters from their physician; and 2) receiving specific instructions on clopidogrel use.~     These findings suggest that there are specific interventions that can be implemented to~     improve clopidogrel adherence.~      Multi-modal interventions that incorporate frequent follow-up, especially with pharmacists~     and use interactive voice response (IVR) technology have improved medication adherence. IVR~     technology is a computer-based telephone system which initiates calls, receives calls,~     provides information, and collects data from users. IVR is currently a mainstay in the VA~     where patients frequently interact with these automated systems to get clinic appointments~     and/or refill prescriptions. IVR as part of multi-modal interventions have been well received~     by patients, increased adherence to medications (e.g., statins), and improved clinical~     outcomes (e.g., blood pressure, diabetes symptoms, health status). In addition, the~     investigators have successfully used IVR as part of a multi-modal, multi-site intervention~     including pharmacists to improve blood pressure levels among hypertensive patients.~     Accordingly, the investigators have designed the intervention to improve clopidogrel~     adherence that builds on the investigators' prior work and other successful adherence~     interventions from the literature.~      The investigators propose a hybrid effectiveness-implementation study of a multi-faceted~     intervention to improve clopidogrel adherence at VA PCI centers. The investigators will use~     the VA's Cardiovascular Assessment Reporting and Tracking (CART-CL), a uniform cath lab~     procedure reporting tool at all VA cath labs. The intervention consists of 4 components: a)~     an alert from CART-CL will be sent to an inpatient pharmacist prior to discharge that a~     patient has received a stent; b) a pharmacist will bring clopidogrel to the patient's bedside~     prior to hospital discharge as well as educate the patient on the importance of and adherence~     to clopidogrel following PCI; c) interactive voice response (IVR) calls will be made to~     patients prior to the time of clopidogrel refill to remind patients and to facilitate refills~     during follow-up; and d) a Patient Aligned Care Team (PACT) member will contact patients who~     delay filling clopidogrel.~   "
149483|NCT01609829|"~     The normal, the anticipated difficult and the unanticipated difficult airway are trained in~     the patient safety simulation center (University Hospital Zürich) and the training is being~     observed by video installation.~      Step 1: normal airway (Phantom), technical training~      Step 2: difficult airway (SimMan 3G), technical training~      Step 3: Simulation of normal and difficult airway management on ICU (SimMan 3G), technical~     and non-technical (CRM - crew resource management) training.~   "
149427|NCT01610570|"~     Background:~      - Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted~     against some forms of cancer, but was never accepted as a treatment. Research suggests that~     it may be useful against some solid tumors, particularly Ewing sarcoma. Researchers want to~     see if mithramycin can be used to treat solid tumors in children and adults. It will be~     tested in different groups of people, including those with a type of Ewing sarcoma that~     contains a chemical called Ewings sarcoma - friend leukemia integration 1 transcription~     factor (EWS-FLI1).~      Objectives:~      - To see if mithramycin is safe and effective against solid tumors and Ewing sarcoma in~     children and adults.~      Eligibility:~        -  Children and young adults between 1 and 17 years of age with solid tumors that have not~          responded to standard treatment.~        -  Adults at least 18 years of age with EWS-FLI1 Ewing sarcoma that has not responded to~          standard treatment.~        -  Children and young adults between 1 and 17 years of age with EWS-FLI1 Ewing sarcoma that~          has not responded to standard treatment.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and tumor tissue samples will be used to~          monitor the cancer before treatment. Individuals with solid brain tumors will not be~          eligible.~        -  Participants will receive mithramycin every day for 7 days, followed by 14 days without~          treatment. Each 28-day round of treatment is called a cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the drug for as long as the side effects are not~          severe and the tumor responds to treatment.~   "
149428|NCT01610557|"~     Background:~        -  Diabetic macular edema is a common eye complication of diabetes. It causes the blood~          vessels in the retina at the back of the eye to leak, causing swelling. The macula is~          the center part of the retina that is important for seeing fine details and for tasks~          such as reading, driving, or sewing. Swelling of the macula leads to vision loss and~          possible blindness. Inflammation may play a role in diabetic macular edema. It is also~          possible that there is a problem with the blood vessels and the blood supply to cells of~          the retina.~        -  A chemical in the body called vascular endothelial growth factor (VEGF) is important in~          the formation of blood vessels in the body. Lowering VEGF levels may help treat diabetic~          macular edema by reducing abnormal leaking blood vessels in the eye. Drugs that can~          lower or block VEGF include ranibizumab and bevacizumab. Both drugs have been shown to~          help treat diabetic macular edema. Researchers want to see if one of the drugs works~          better than the other.~      Objective: To compare the effectiveness of ranibizumab and bevacizumab injections for~     diabetic macular edema.~      Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least~     one eye.~      Design:~        -  Participants will be screened with a physical exam and medical history. A full eye exam~          will be performed. Blood and urine samples will be collected.~        -  One eye will be selected as the study eye to receive treatment. If both eyes are~          affected, both eyes may be enrolled in the study and receive different drug treatments.~        -  The main part of the study will last for 9 months. At each study visit, participants~          will have physical exams and eye exams. They will answer questions about their health~          and any side effects from the drugs.~        -  Participants will be assigned to one of four groups. Two groups will have two series of~          ranibizumab and one series of bevacizumab shots. The other two groups will have two~          series of bevacizumab and one series of ranibizumab shots. A series is three eye~          injections of the same drug every 4 weeks. The injections will be given at these study~          visits. The series order will vary for the different groups.~        -  After 9 months, participants will continue to have additional study visits. If the~          treatment seems to be successful, the study doctor may increase the time between visits.~          Study injections may be given as needed every 4 weeks for up to 3 years.~        -  Participants may have laser treatments in a study eye if needed. After being in the~          study for 1 year, they may also have steroid injections or other treatments as directed~          for the macular edema.~   "
149429|NCT01610544|"~     Background:~      - Imaging studies like positron emission tomography (PET) and computed tomography (CT) scans~     are used to detect tumor responses to cancer treatment. However, it may be difficult to~     detect early response to lung cancer or thymoma treatment with standard PET/CT scans. These~     scans cannot easily show a difference between remaining cancer cells and inflammation.~     Researchers want to try a new PET/CT scan tracer that may be able to show the difference~     between these cells. 18F-Fluorothymidine (18F-FLT) is better at showing which cells are still~     actively dividing. PET/CT scans with 18F-FLT may help show if tumor cells are responding to~     early stages of treatment.~      Objectives:~      - To see if 18F-FLT is a safe and effective imaging study tracer to show early cancer~     response to treatment.~      Eligibility:~      - Individuals at least 18 years of age who are being treated for lung cancer or thymoma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood, urine,~          and tumor tissue samples will be collected.~        -  Participants will have two PET/CT scans on separate days before starting chemotherapy.~          One scan will be with a standard radiotracer. The other will be with the 18F-FLT tracer.~        -  About 2 weeks after starting chemotherapy, participants will repeat the two PET/CT scans~          on separate days. Additional blood samples will be collected at this time.~   "
149430|NCT01610531|"~     Melanoma is nowadays an important public health problem because its growing incidence. Mass~     screening for melanoma is not recommended worldwide because of its low cost-effectiveness.~     Nevertheless targeted screening for patients at high risk for melanoma is promoted. This~     study is designed to assess the effectiveness and the acceptability of a melanoma targeted~     screening of melanoma, to estimate the risk function to develop a melanoma among patients at~     high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma~     targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a~     registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk~     according to the SAMScore were proposed a skin examination by their GP every year.~   "
149431|NCT01610518|"~     The ability of oat β-glucan to lower postprandial glycemic responses has been attributed to~     the viscosity of the solution in which the fibre is solubilized. To our knowledge, no studies~     have investigated the effect of β-glucan solutions on glycemic response when concentration,~     and thus viscosity, is varied by changing the solution volume but not the β-glucan dose.~     Therefore, the investigators will test the effects of altering β-glucan solution viscosity by~     altering solution volume at a fixed amount of β-glucan fibre.~   "
149432|NCT01610505|"~     The purpose of the post-market study is to demonstrate that the KineSpring System is~     non-inferior to high tibial osteotomy in safety and effectiveness in the treatment of~     symptoms associated with osteoarthritis of the medial compartment of the knee.~   "
149484|NCT01609816|"~     This study uses a drug called dasatinib to produce an anti-cancer effect called large~     granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as~     natural killer cells that remove cancer cells. Researchers think that dasatinib may cause~     large granular lymphocyte expansion to happen in patients who have received a blood stem cell~     transplant (SCT) between 3 to 15 months after the blood SCT. In this research study,~     researchers want to find how well dasatinib can be tolerated, the best dose to take of~     dasatinib and to estimate how often large granular lymphocytic cellular expansion happens at~     the best dose of dasatinib.~   "
154980|NCT01537705|"~     A clinical outcomes study measuring reduction in pain and numbness experienced in four types~     of peripheral neuropathy patients during 60 day administration of the an amino acid~     formulation.~   "
149433|NCT01610492|"~     This is a phase II, open label, experimental medicine study to evaluate the efficacy, safety~     and mechanism of action of belimumab in subjects with antiphospholipase A2 receptor (PLA2R)~     autoantibody positive idiopathic membranous glomerulonephropathy (IMGN), and to profile the~     relationship between biomarkers, autoantibody status and clinical response. 10 milligrams per~     kilogram (mg/kg) belimumab intravenous (IV) will be administered at weeks 0, 2, and then~     every 4 weeks, over a 24-week treatment period in subjects with anti-PLA2R antibody positive~     IMGN followed by a further long term treatment period until subjects reach remission of~     proteinuria, up to a maximum of 2 years total treatment. All subjects will receive background~     supportive therapy throughout the study. The dosing frequency will be adjusted to every 2~     weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is~     greater than 1000 milligrams per millimole (mg/mmol) [greater than 10 grams(g)/24 hours (h)],~     to compensate for loss of belimumab in the urine. Effects on mechanistic markers will be~     measured by the level of proteinuria, levels of anti-PLA2R antibodies, and various other~     measures of kidney function. These will be compared to historical data. The pharmacokinetics~     of belimumab will be measured to confirm dosing in heavily proteinuric subjects.~     Pharmacodynamic (PD) markers, biomarkers and Quality of Life(QoL) in IMGN subjects will also~     be investigated. Safety will be assessed by adverse events (AE), clinical laboratory~     evaluations, and vital signs.~   "
149434|NCT01610479|"~     This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid~     tumors.~   "
149435|NCT01610466|"~     Laparoscopic bariatric surgery is an advanced laparoscopic procedure with a potential for~     significant morbidity and mortality along the early part of a surgeon's learning curve.~     Simulation-based training has been shown to improve a surgeon's technical performance and~     shorten the learning curves in the operating room. Despite these benefits, there is no~     evidence-based ex-vivo training curriculum for laparoscopic bariatric surgery. The purpose of~     this study is to design and validate such a curriculum. This curriculum will include~     cognitive training, technical laparoscopic skills training (laparoscopic gastrojejunostomy~     and jejunojejunostomy) and non-technical skills training in a simulated environment. The~     investigators will assess the effectiveness of the proposed curriculum by conducting a~     randomized single blinded controlled trial. Cognitive knowledge (multiple choice test),~     technical skills (performance of a procedure in the operating room) and non-technical skills~     (performance in a simulated crisis scenario in a simulated environment) will be compared~     between curriculum trained and conventionally trained groups. The investigators hypothesize~     that curriculum trained group will have superior knowledge, technical skill and non-technical~     skills compared to conventionally trained group.~   "
149436|NCT01610453|"~     Objectives~        1. To assess if head-perineum distance and angle of progression measured with transperineal~          ultrasound by the obstetrician on call can predict delivery mode in primiparous women~          with prolonged first stage of labour.~        2. To compare ultrasound assessments and clinical examinations.~   "
149437|NCT01610440|"~     Duchenne muscular dystrophy (DMD), an X-linked recessive genetic disease always progressed~     slowly，tends to leading proximal skeletal muscle atrophy and weakness of limbs, as well as~     impaired respiratory muscle and cardiac muscle. To a large extent, patients always lose motor~     function gradually and die for heart failure or severe infection at the end stage of DMD. At~     present, the treatment strategy relies on heteropathy accompanied with rehabilitation~     training. However, the therapeutic effect remains extremely limited.~      Human umbilical cord mesenchymal stem cells (hUC-MSCs) have been evidenced to improve motor~     function, increase muscle strength and reduce abnormal levels of related enzymes, such as~     creatine kinase (CK), lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and~     aspartate aminotransferase (AST). This study is aimed to explore the safety and efficacy of~     hUC-MSCs transplantation for DMD.~   "
149438|NCT01610427|"~     The purpose of this study is to investigate a combined set of parameters deemed to impact the~     quality of CMI analyses in terms of the proportion of viable lymphocytes in antiretroviral~     therapy-naïve HIV-1 infected subjects.~   "
149439|NCT01610414|"~     The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A~     in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant~     recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy~     (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in~     reducing the risk of developing HZ in this population.~   "
149440|NCT01610401|"~     In acute myocardial infarction early restoration of coronary blood flow is the most effective~     strategy to limit infarct-size. Paradoxically, reperfusion itself also aggravates myocardial~     injury and contributes to final infarct size, a process termed 'reperfusion injury'. Ischemia~     and reperfusion (IR)-induced endothelial dysfunction seems to play a pivotal role in this~     process, resulting in vasoconstriction and reduced blood flow to the already ischemic tissue.~     Recently, it has been shown that the glucose-lowering drug metformin is able to limit~     IR-injury in murine models of myocardial infarction, probably by increased formation of the~     endogenous nucleoside adenosine. In the current research proposal, the investigators aim to~     translate this finding to the human in vivo situation, using flow-mediated dilation (FMD) of~     the brachial artery as a well-validated model of (endothelial) IR-injury.~   "
149441|NCT01610388|"~     This first time in human (FTIH) study will be the first administration of GSK1322322 as an~     intravenous formulation and will investigate safety, tolerability, and pharmacokinetics in~     healthy subjects. One cohort of subjects will undergo bronchoalveolar lavage (BAL) for~     determination of GSK1322322 concentrations in lung with simultaneous comparison to plasma~     concentrations to evaluate drug penetration in the lung. The study will evaluate the absolute~     bioavailability of an oral tablet formulation as compared to the IV formulation.In addition,~     Amendment 01 will enable the investigation of an improved IV formulation (GSK1322322J~     mesylate salt) in an additional repeat dosing cohort and the supra-therapeutic cohort.~   "
149485|NCT01609803|"~     This research trial studies protein expression in tissue samples from younger patients with~     rhabdomyosarcoma. Studying samples of tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors find better ways to treat cancer.~   "
155313|NCT01533311|"~     The nonpolypoid colorectal neoplasms (NP-CRNs) are relatively common in patients with~     gastrointestinal alarm systoms. The depressed lesions have a greater risk of having cancer~     than flat and polypoid lesions.~   "
149442|NCT01610375|"~     The aim of this study is to investigate the feasibility, safety and accuracy of a telephone~     follow-up for women previously treatment for endometrial cancer.~      To achieve this aim, potentially eligible women attending the Queensland Centre for~     Gynaecological Cancer (QCGC) outpatient clinic for review following previous treatment for~     endometrial cancer will be recruited by this study. The study aims to recruit all new~     patients as well as all patients who return to QCGC for their follow-up and who had treatment~     within the previous 2 years.~      The proposed project will involve generation of an evidence-based checklist of signs and~     symptoms of disease recurrence from a thorough literature review. The generated symptom~     checklist will be pilot tested and the refined symptom checklist will be used to follow study~     participants over a period of 12 months.~      During the follow-up period, the basic standard of follow-up after primary treatment for~     endometrial cancer at the QCGC, Royal Brisbane and Women's Hospital (RBWH)will not be~     altered; however, the study participants will be interview via telephone 2 to 5 days prior to~     their scheduled review dates.~      The main outcome measure will be the estimated recurrence rate as derived from the telephone~     assessment and this will be compared to the clinically detected recurrences as recorded in~     patients' medical files.~      It is hypothesized, that the telephone follow-up will identify 90% of all recurrences~     correctly that are later confirmed during the clinical follow-up.~      In addition to the main outcome, we will also assess patients' satisfaction with each of the~     follow-up programs, whether or not lifestyle behaviours were queried and support offered to~     improve wellbeing.~   "
149443|NCT01610362|"~     Dosage of rabies immune globulin was calculated from the victim's body weight, then the~     amount of rabies immune globulin would be injected as much as possible to all of the wounds.~     Increase dosage of rabies immune globulin was needed in situation of multiple severe~     bite-wounds especially among children whose had lower body weight than adults. Our study~     would be conducted in order to determine whether the increase dosage of rabies immune~     globulin would interfere with the protective antibody levels against rabies.~   "
149444|NCT01610336|"~     This study will assess the safety and efficacy of escalating doses INC280 when added to~     gefitinib in patients with lung cancer that are known to have dysregulation of the c-MET~     pathway and who have failed after benefiting on a prior treatment with either gefitinib or~     erlotinib.~   "
149445|NCT01610323|"~     In pregnancy, the adoption or pursuit of a sedentary lifestyle contributes to the development~     of co-morbid conditions such as hypertension, maternal and childhood obesity, gestational~     diabetes, pre-eclampsia, cesarean section and delivery of large-for-gestational-age infants~     (LGA).~      The aim of this study is to test the hypothesis that obese, pregnant women following a~     supervised moderate intensity physical conditioning program during the 2nd trimester of~     pregnancy will maintain a higher level of physical activity up to the end of pregnancy, as~     compared to women in the control group. We will also conduct a pilot study on the feasibility~     to examine the effects of the intervention on maternal fitness and neonatal anthropometry.~   "
149446|NCT01610310|"~     The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and~     tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or~     prefilled syringe (PFS) in healthy volunteers to support the development of the autoinjector.~   "
149447|NCT01610297|"~     This was a prospective, single-arm, multicenter, national, phase II clinical study. The~     purpose of this Phase II study was to examine the safety and efficacy of deferasirox to~     decrease iron overload (IOL) in the posttransplant period in patients with beta-thalassemia~     major.~   "
149448|NCT01610284|"~     The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant~     is effective and safe in treating patients with hormone receptor-positive, HER2-negative~     locally advanced or metastatic breast cancer refractory to aromatase inhibitor.~   "
149449|NCT01610271|"~     Airborne particles are present in all indoor environments including the operating room. Most~     of these particles come from the surgical staff moving around in the room, positioning of the~     patient during surgery, and the movement of surgical equipment and supplies. While the amount~     of particulate in an operating room is much, much less than is found in a typical home or~     public space, some particulate is usually present no matter how the room and air are cleaned~     and filtered. Typically these few particulate cause no problems, but the goal is always to~     have the cleanest air possible during surgery. The Air Barrier System (ABS) consists of a~     reusable blower and a sterile nozzle. The blower feeds filtered air into the sterile~     disposable nozzle, which disperses a constant stream of gentle, high purity air over the~     surgical incision. This stream of air forms a shield over the surgical area to prevent~     airborne particulate from settling into the open wound. This is particularly critical for~     long-duration surgeries, such as procedures that involve the implantation of a prosthesis.~     The main objective of this research study is to determine whether the ABS can reduce the~     potential for surgical site infection during total hip replacement, spinal fusion, or lower~     extremity bypass grafting procedures. These procedures were chosen because each is a~     long-duration procedure which involves implantation of prosthesis.~   "
149450|NCT01610258|"~     The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level~     modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in~     women hospitalized for PPROM.~   "
149451|NCT01610245|"~     This study is a global multicenter randomized factorial double-blind, placebo-controlled~     trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally~     twice daily for five days compared to a placebo in the treatment of acute uncomplicated~     influenza and (ii) efficacy and safety of combination therapy with nitazoxanide 600 mg plus~     Oseltamivir 75 mg co-administered orally twice daily for five days compared to nitazoxanide~     monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy (75 mg b.i.d. for 5 days)~     in the treatment of acute uncomplicated influenza.~   "
149452|NCT01610232|"~     The investigators hypothesis is that the infrared-LED illumination during treadmill training~     can enhance physical performance in postmenopausal women. The basis for such a hypothesis is~     based on the fact that the light therapy during the intense metabolic stage caused by~     exercise may be more efficient.~   "
149566|NCT01608750|"~     The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI)~     treatment in patients with functional dyspepsia.~   "
162738|NCT01435733|"~     The purpose of this study is to investigate whether the presence of a child with Autism~     Spectrum Disorder places parents at increased risk for divorce.~   "
149453|NCT01610219|"~     The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a~     concerning public health trend. There has been little research testing ways to prevent the~     development of this disease in children who are at increased risk to develop T2D. This study~     tests a family treatment program that treats 4-8 year old children who are at risk for T2D~     because they are overweight and have a family history of the disease. Sixty at risk children~     and their parents were assigned to one of 2 treatment conditions. Half of the families~     (randomly determined) received an intensive family treatment program that trains parents in~     how to increase healthier foods choices and physical activity for themselves and their~     children using behavior modification strategies. Children receiving this treatment were~     allowed to taste new fruits and vegetables used a pedometer to record how far they walked~     every day, and were given a tool box of toys and interactive games which promoted physical~     activity. The other half of the families only received instruction about healthier choices,~     but received no behavioral modification strategies or physical activity promotion tools.~     Improvements in children's body weight, blood measures, and behavior patterns were measured~     after treatment ended (6 months) and then again after 12 months. The results may lead to a~     better understanding of how family members can positively influence young children's~     behaviors to help prevent T2D. The objective of proposed study was to test a family-based~     intervention designed to reduce excess body weight, improve metabolic and cardiovascular~     profile, and improve diet and physical activity levels in 4 - 8 year old youth who are at~     risk for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial.~      Primary Hypotheses:~        1. Compared to children receiving NPA, children receiving LMDP will show greater reductions~          in excess body weight, greater improvements in metabolic and cardiovascular measures,~          improved diet, increased physical activity, and reduced television viewing.~        2. Greater reductions in child excess body weight will be associated with greater~          improvements in metabolic and cardiovascular measures.~      Secondary Hypotheses:~        1. Compared to parents receiving the NPA intervention, parents receiving the LMDP~          intervention will show greater reductions in BMI.~        2. Greater improvements in parent BMI will be associated with greater improvements in child~          body composition, metabolic and cardiovascular measures, and behavioral outcomes.~        3. Compared to families receiving the NPA intervention, families receiving the LMDP~          intervention will show an increase in the number of fruits and vegetables and lower~          energy density foods stored at home.~   "
149454|NCT01610206|"~     Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common~     cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian~     cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients~     with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib~     is a novel agent has recently been approved for the treatment of subjects with advanced renal~     cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers~     such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and~     safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for~     recurrent or persistent ovarian cancer. This is an open label study in which subjects will be~     randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib.~     Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle.~     Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All~     subjects will be monitored for toxicity and other indicators of safety (labs, physical exams,~     vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5~     years following the conclusion of treatment to evaluate efficacy. The primary endpoints of~     the study are progression free survival and overall survival, which will be assessed at three~     years.~   "
149455|NCT01610193|"~     PSP (Pancreatic Stone Protein) is a compound naturally produced mainly in the pancreas and~     the gut. There is evidence from experimental and clinical trials that the levels of PSP in~     the blood rise in the presence of inflammation or infection. What is not yet well known about~     PSP is whether it is superior to other established blood tests (e.g. WBC or CRP) in~     predicting appendicitis in patients that present at the emergency room with abdominal pain~     and a clinical suspicion of appendicitis.~   "
149456|NCT01610180|"~     With conventional treatments (i.e. iv Ig, steroids) the overall response rate of ITP~     secondary to LPD is generally lower than in primary ITP, and usually not higher than 50% (95%~     CI 27-72). Eltrombopag which has proved very effective in primary ITP could be effective also~     in ITP secondary to LPDs.~      This novel ITP specific treatment might spare these patients not only from bleeding risk but~     also from toxic or inappropriate cytotoxic therapies, not otherwise demanded by the burden of~     the underlying disease.~   "
149457|NCT01610167|"~     The study is intended to verify through clinical measurement that the NUPRO Sensodyne~     Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended~     relief up to 28 days.~   "
149458|NCT01610154|"~     1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon~          release and improve glucose control in Chinese type 2 diabetic.~        2. There are different effects of Sitagliptin therapy on blood glucose regulation,~          pancreatic alpha & beta cell function are different in lean (BMI<25) and overweight~          (BMI>25) Chinese type 2 diabetics.~        3. The purpose of this study is to determine whether glucagon release may contribute over~          30% to the hyperglycemia in Chinese type 2 diabetics.~   "
149459|NCT01610141|"~     The purpose of this study is to determine whether pharmacogenetic guided dosing of warfarin~     is promising for the improvement of efficiency, therapeutic efficacy, and, especially, safety~     of warfarin therapy than a dosing regimen without the pharmacogenetic information in Chinese~     patients initiated on warfarin anticoagulation.~   "
149460|NCT01610128|"~     The aim of the project is to develop a patient reported outcome instrument to assess disease~     control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.~   "
149461|NCT01610115|"~     To elucidate the natural course of chronic hepatitis B by serial HBV DNA and alanine~     aminotransferase (ALT) levels during pregnancy~   "
149462|NCT01610102|"~     The primary objective of this study is to collect long term clinical follow-up data on all~     patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0~   "
149463|NCT01610089|"~     The urea cycle consists of a series of chemical reactions through which the body converts~     toxic waste- nitrogen into a substance called urea that can be disposed of easily. While~     disposal of nitrogen is the major function of the urea cycle, recent research has shown that~     some enzymes of the urea cycle are also important for the production of nitric oxide. Nitric~     oxide is an important chemical that has many functions in the human body including regulation~     of blood pressure. Through this study, the investigators will study the production of nitric~     oxide in subjects with citrullinemia type 1 by administering stable isotopes to these~     subjects. Stable isotopes are harmless compounds that can be used to track and measure the~     production of specific compounds in the human body. The overall goal of this study is to~     understand if citrullinemia patients have a deficiency of nitric oxide production. This~     knowledge may have an impact on the treatment of patients with citrullinemia.~   "
149777|NCT01605981|"~     This is an open label, non randomized, prospective, multicenter, phase II clinical trial~     evaluating nilotinib 400 mg BID for the treatment of newly diagnosed CML-AP patients.~      Patients enrolled into the study will receive 400mg of nilotinib, orally, twice daily~     (800mg/day)~   "
149469|NCT01610011|"~     The purpose of this study is to use proton magnetic resonance spectroscopy (MRS) at 4 Tesla~     to measure brain glycine levels noninvasively at baseline and for 2 hours after a single oral~     dose of a concentrated glycine-containing beverage, and to compare MRS glycine measurements~     to glycine blood levels in samples obtained after each MRS spectrum.~      The investigators hypothesize that they will observe a high correlation between the magnitude~     increases in brain and plasma glycine levels over this time frame.~      The investigators also hypothesize that we will observe large intersubject variability in~     glycine uptake rates into brain and blood.~      The investigators also hypothesize that subjects with a glycine decarboxylase (GLDC) mutation~     (triplication) will have lower baseline plasma and brain glycine levels and will experience~     smaller brain and plasma glycine increases after glycine consumption than controls or family~     members without the GLDC mutation.~   "
149470|NCT01609998|"~     This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to~     evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the~     2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV vaccine.~     The comparator groups will receive licensed 2012/2013 TIV as prime and boost. The hypothesis~     is that the 2012/2013 HA DNA prime-TIV boost regimen will be safe and result in a broader and~     more durable immune response than is observed in age-matched comparator TIV-TIV groups.~   "
149471|NCT01609985|"~     The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute,~     prospective, non-randomized multi-center feasibility clinical trial. The purpose of this~     clinical trial is to collect data to assist in the testing and finalization of a hemodynamic~     sensor-based cardiac resynchronization therapy (CRT) optimization scheme.~   "
149472|NCT01609972|"~     The purpose of this investigational study is to establish the safety and effectiveness of~     electrical stimulation delivered to the spinal cord in subjects with chronic, intractable~     pain of the trunk and/or limbs and will be a comparison of the Senza System with commercially~     available SCS systems.~   "
149473|NCT01609959|"~     The purpose of this study is to compare blood pressure lowering effect of azilsartan with~     that of valsartan in Japanese patients with hypertension who have already taken normal-dose~     angiotensin II receptor blockers.~   "
149474|NCT01609946|"~     The study is an open, prospective multicenter study. According to the statistical sample size~     calculation 593 patients with thyroid nodules ≥ 5mm in size will be included in the study.~     Reference methods are cytology obtained by Fine needle aspiration biopsy (FNAB) or histology~     obtained by surgery.~      All patients will receive an B-mode and Duplex ultrasound examination of the thyroid gland,~     as well as Realtime Elastography of thyroid nodules.~      Results of B-mode and Duplex ultrasound are compared to Realtime Elastography to evaluate the~     additional value of Realtime Elastography in the diagnostic work up of thyroid nodules.~   "
149475|NCT01609933|"~     A study to evaluate the safety and effect of treatment with experimental antiviral drugs in~     combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who~     did not respond to treatment in a previous AbbVie/Abbott combination study.~   "
149476|NCT01609920|"~     The aim of this study is to examine the diagnostic performance of gadofosveset enhanced~     magnetic resonance imaging lymphography (MRL).~      The diagnostic performance of MRL will be determined on the basis of a node-to-node matching~     of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel~     lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the~     golden standard for nodal involvement.~   "
149477|NCT01609907|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and~     valsartan in healthy male volunteers.~   "
149478|NCT01609894|"~     The proposed research will investigate individualized fortification of breast milk based on~     daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind~     controlled trial. The combination of additional fat, carbohydrate and protein and commercial~     fortifier will be added to ensure that the milk contains the target amounts of nutrient.~     Growth and development of these infants will be compared with that of infants fed mother's~     milk that has been supplemented with the current standard amounts. The postnatal growth of~     the infants will be assessed by measuring weight, length and head circumference and fat and~     lean mass using highly accurate, non-invasive methods throughout the intervention period and~     at the first follow-up visit after discharge at 3 months. Neurological development will be~     analyzed at the age of 18 months.~      The investigators hypothesize that individualized fortification of breast milk improves the~     nutritional intake of preterm infants, optimizing growth, and thus this will positively~     impact neurodevelopment and health.~   "
149479|NCT01609881|"~     Objective of the research study:~        1. To measure anterior chamber and vitreous ketorolac (Acuvail®) concentrations after~          topical administration in patients undergoing routine vitrectomy to determine the~          ability of the medication to penetrate into the anterior chamber and vitreous cavity,~          and to compare these levels to the IC50 for the cyclooxygenase-1 and -2 enzymes (COX-1~          and COX-2)~        2. To measure vitreous concentrations of prostaglandin subtypes (PGE, PGD, PGF) and other~          inflammatory mediators (Interleukin-1β [IL-1β], IL-6, IL-8, tumor necrosis factor~          [TNF]-α, VEGF) in both diabetic and nondiabetic patients undergoing vitrectomy~        3. To determine if topical ketorolac (Acuvail®) can penetrate the anterior chamber and~          vitreous cavity sufficiently to decrease levels of intraocular inflammatory mediators~          that have been shown to be elevated in diabetic patients~        4. To serve as a precursor to a 5-year longitudinal clinical trial to determine if~          chronically administered topical ketorolac (Acuvail®) can prevent, delay or slow~          diabetic retinopathy.~      Research hypothesis~        1. Ketorolac (Acuvail®) will penetrate the anterior chamber and vitreous cavity~          sufficiently to achieve levels above the IC50 for COX-1 and COX-2~        2. Prostaglandin and other inflammatory mediator levels in the anterior chamber and~          vitreous cavity will be significantly higher among diabetic patients than nondiabetic~          controls~        3. Acuvail® can significantly lower anterior chamber and vitreous cavity levels of~          prostaglandins and other inflammatory mediators in diabetic patients~   "
149480|NCT01609868|"~     The investigators hypothesis that premature infants receiving a commercially available liquid~     protein modular will have improved growth when compared with premature infants receiving a~     commercially available powder protein modular.~   "
149486|NCT01609790|"~     This partially randomized phase II trial with a safety run-in component studies the side~     effects and how well bevacizumab given with or without trebananib works in treating patients~     with brain tumors that have come back (recurrent). Monoclonal antibodies, such as~     bevacizumab, may block tumor growth in different ways by targeting certain cells. Trebananib~     may stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known~     whether giving bevacizumab together with trebananib is more effective than bevacizumab alone~     in treating brain tumors.~   "
149487|NCT01609777|"~     A handover Tool for doctors and nurses improves the quality of handovers compared to~     handovers that are being conducted without a tool.~      In the present study the investigators will develop and evaluate a handover Tool for doctors~     and nurses. The investigators seek to answer the following research questions:~        1. Does the tool improve quality (i.e. efficiency and accuracy)?~        2. Does the tool improve safety relevant attitude an perceived team collaboration?~   "
149488|NCT01609764|"~     Ageing is associated with a reduction of physical activity, movement efficiency, and quality~     of sleep. This leads to reduced health and well being in elderly subjects. Exercise training~     can increase movement efficiency and quality of sleep.~      Objectives:~        1. Laboratory validation test of body acceleration based indexes for movement efficiency~          and quality of sleep;~        2. Cross-sectional analysis to assess relations between these indexes and age;~        3. Intervention study to assess the effect of exercise training on daily life movement~          efficiency and quality of sleep in ageing subjects~      45 healthy human volunteers, age 50-83 yr, BMI 20-30 kg/m2 are divided in control or~     intervention group. Subjects that will have practiced fitness activities in the previous~     year, as well as pregnant or lactating women, will be excluded.~   "
149489|NCT01609751|"~     There is evidence to show that daily probiotic Lactobacillus casei Shirota (LcS) in the form~     of Yakult fermented milk supports a healthy balanced population of friendly gut bacteria.~     This, coupled with evidence from four European trials showing probiotic benefit for recurrent~     diverticulitis and an understanding of how the disease develops, indicates that LcS may also~     be beneficial. The investigators plan to undertake a pilot study investigating whether~     consumption of once daily probiotic LcS as Yakult fermented milk would help either prevent~     attacks of diverticulitis completely or significantly reduce frequency of attacks. Subjects~     will be recruited from Surrey primary care units and will be closely monitored for 12 months~     whilst being supplied with a daily dose of for the full 12 months to see if this improves gut~     health.~   "
149490|NCT01609738|"~     Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right~     ventricular apex (RVA) has become the most frequently used ventricular pacing site. However,~     RVA pacing has been shown to cause left ventricular (LV) dyssynchrony wich can lead to LV~     dysfunction and development of heart failure. Recent studies in animals have demonstrated~     that pacing at the LV septum induces significantly less ventricular dyssynchrony than RVA~     pacing and is able to improve LV function to a similar degree as biventricular (BiV) pacing.~     In addition it was shown that a LV septum lead can be placed permanently by driving a lead~     with extended helix from the RV side through the inter-ventricular septum into the LV~     endocardial layer. This was shown to be a feasible and safe procedure and lead stability was~     shown during four months of follow-up in otherwise healthy and active canines. LV septum~     pacing may therefore be a good treatment alternative in patients with symptomatic~     bradycardia, as well as patients with an indication for cardiac resynchronization therapy~     (CRT). The purpose of this study is to translate the findings from preclinical studies to the~     clinical situation by investigating the feasibility, long-term lead stability and safety of~     LV septum pacing by transvenous approach through the inter-ventricular septum in patients.~   "
149491|NCT01609725|"~     Gingival inflammation has been associated with cardiovascular diseases, including heart~     attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose~     and C reactive protein. The treatment of gingival diseases decreases the concentration of~     these risk factors in the blood of cardiovascular patients.~   "
149492|NCT01609712|"~     Patients with vertebral fractures often have problems to straighten and as a consequence of~     impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to~     the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer~     expansion of the lung. Pain is also caused by respiratory excursions of the chest which~     hinder the patients to use their entire lung volume.~      Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing~     stability to the fracture.~      In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.~   "
149493|NCT01609699|"~     The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical~     motion within fat tissues and cells for the purpose of producing mechanical cellular membrane~     disruption. It is intended for reduction in body circumference.~      The primary objective of this study is to evaluate the efficacy of the Contour I - Y System~     on abdominal circumference reduction relative to baseline pretreatment values using different~     treatment methods.~      The primary efficacy endpoint in this trial is Statistical Difference of Circumference~     reduction between Baseline measurement and at follow-up measurement.~   "
149494|NCT01609686|"~     Cardiopulmonary bypass surgery is associated with extensive blood loss in upto 20% of~     patients. Tranexamic acid (TXA) is a routinely administered antifibrinolytic agent that~     reduces blood loss and blood transfusion requirement. However, standard dosing of TXA in~     patients suffering from renal dysfunction and undergoing cardiopulmonary bypass surgery may~     lead to higher blood concentration of TXA when compared to the patients with normal renal~     function. Solid phase microextraction (SPME) is a fast and simple method to measure TXA~     levels. This prospective study on cadiac surgical patients undergoing cardiopulmonary bypass~     aims to study the pharmacokinetics of TXA in patients with renal dysfunction. Two patient~     groups will be studied who will receive either TXA 50mg/kg bolus or BART regimen (30 mg/kg,~     16 mg/kg/h + 2 mg/kg pump prime) depending on the type of cardiac surgical procedure and~     bleeding risk.~      Hypothesis: Standard dosing of TXA used in cardiac surgery result in higher blood~     concentration of TXA in patients with renal dysfunction when compared to patients with normal~     renal function.~   "
150795|NCT01592708|"~     The purpose of this study is to determine whether a multi-modal anesthesia and pain control~     protocol reduces post-operative and post-discharge nausea and vomiting (PONV and PDNV) in~     patients undergoing upper jaw corrective surgery.~   "
149495|NCT01609673|"~     In the present study, the investigators propose a conversion scheme with 50% reduction in CNI~     dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10~     ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes.~      The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic®~     and Certican® significantly improves renal function compared with the standard regimen of~     CNI.~   "
149496|NCT01609660|"~     The purpose of this study is to assess the impact of probiotic administration (Saccharomyces~     boulardii) on patients undergoing colorectal resections comparing to the routine protocol by~     assessing: (1)intestinal microbiota modulation using RT-PCR to measure cytokine in the~     mucosa; (2) assess postoperative complications, mainly infectious and mortality, as well as~     length of hospital stay~   "
149497|NCT01609647|"~     High platelet reactivity unit (PRU) after loading dose clopidogrel in patients undergoing~     percutaneous coronary intervention (PCI) is related to high risk of short and long term~     recurrent ischemic events including stent thrombosis.~      The investigators hypothesize that additional loading of prasugrel in patients with high PRU~     after clopidogrel loading would be superior to additional loading of clopidogrel in reducing~     platelet reactivity and thereby result in lower risk of short term recurrent ischemic events.~   "
149498|NCT01609634|"~     This study is initiated to investigate the effect of a new infant formula in healthy term~     subjects on growth, body composition, tolerance and safety.~   "
149499|NCT01609621|"~     The objective of this prospective, non-randomized, multicenter, post-market, observational~     study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access~     and to cross infrainguinal arterial occlusions.~   "
149500|NCT01609608|"~     1. Aim: The aim of this trial was to determine whether whole-body vibration (WBV) induced~          via a non-invasive oscillation platform could improve symptoms and health-related~          quality of life (HRQOL) in patients with chronic functional constipation.~        2. Methods: A single-blinded, randomized, control trial was performed in a single Hospital~          in Taiwan. Patients diagnosed with chronic functional constipation, as per the Rome III~          diagnostic criteria were included and randomized to either the WBV treatment or no~          treatment (control) group. The treatment group received six 15-minute sessions of WBV~          therapy over a two-week period. Patients received vibrations of 2 mm in amplitude at a~          frequency of 12 Hz. The primary outcome was assessed by the constipation severity~          instrument (CSI). The secondary outcome was improvements in HRQOL.~   "
149501|NCT01609595|"~     Beta thalassemia intermedia is an inherited blood disease caused by molecular mutations which~     reduce the beta globin protein chain of adult hemoglobin A, the protein in red blood cells~     which carries oxygen throughout the body. Beta thalassemias cause progressively severe~     anemia, widespread organ damage, and often require blood transfusions. There is no FDA~     approved therapeutic to treat the underlying cause of beta thalassemia. Fetal hemoglobin is~     another type of endogenous hemoglobin which can replace the reduced beta globin protein,~     reduce the anemia, and even abolish transfusion requirements. This type of hemoglobin is~     normally suppressed in infancy.~      Sodium 2,2 dimethylbutyrate (ST20, or HQK-1001) is a small molecule which stimulates~     production of fetal hemoglobin in nonhuman primates and in human patients in Phase I/II~     trials.~      This is a Phase 2 open-label trial to evaluate the ability of this oral therapeutic to reduce~     anemia in patients with beta thalassemia intermedia, when administered once daily for 26~     weeks. All participants will receive the study drug.~   "
149502|NCT01609582|"~     The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite~     events exists following long term treatment with TAK-875 compared with placebo.~   "
149503|NCT01609569|"~     The aim of this study is to determine on preliminary basis weather an elevated pro-calcitonin~     level can be used to assess ischemia as a result of coronary artery complications during~     percutaneous coronary intervention (PCI).~   "
149504|NCT01609556|"~     The purpose of this study is to test IMGN853 in patients with FOLR-1 positive tumors.~   "
149505|NCT01609543|"~     This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of~     Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or~     metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR)~     activating mutations. Patients will receive Tarceva 150 mg orally daily until disease~     progression or unacceptable toxicity occurs.~   "
149506|NCT01609530|"~     Verruca vulgaris (VV), or the common wart, is a relatively prevalent and often frustrating~     cutaneous disease to treat. A single, highly effective therapy for the treatment of VV has~     not been found. Liquid nitrogen is considered the standard of care for VV and studies report~     a 44% to 47% cure rate. In search of more efficacious and convenient therapeutic options, a~     variety of lasers have been reported in the treatment of VV including the Nd:YAG laser~     (1064nm). Lasers offer the potential for decreased treatment associated pain, fewer office~     visits, higher cure rates and lower recurrence rates. However, many of the available~     published studies draw conclusions from case reports and small case series without any~     randomized controlled trials. A randomized, controlled study is needed to evaluate the~     efficacy of the microsecond Nd:YAG (1064nm) compared to conventional cryotherapy.~      This study will use the Cutera CoolGlide Nd:YAG laser that operates in the infrared spectrum~     at a wavelength of 1064nm. This a single site, double blind, randomized controlled clinical~     trial to evaluate the efficacy of the Nd:YAG laser (Cutera) in the treatment of verruca~     vulgaris of the hands and feet versus conventional liquid nitrogen therapy.~      The investigators hypothesize that there will be a significantly higher number of warts with~     complete resolution at 4 months follow-up in the Nd:YAG treated group versus the liquid~     nitrogen therapy group. The investigators also hypothesize that there will be a faster time~     to complete resolution of the verruca in the Nd:YAG treated group versus the liquid nitrogen~     treated group.~   "
149507|NCT01609517|"~     In these prospective observational study, the investigators are trying to evaluate (1) the~     influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal~     anesthetic outcome by logistic regression analysis.~   "
149508|NCT01609504|"~     The present prospective randomized study investigated the results of ELRR (ENDOLUMINAL~     LOCO-REGIONAL RESECTION BY TRANSANAL ENDOSCOPIC MICROSURGERY) versus LTME (LAPAROSCOPIC TOTAL~     MESORECTAL EXCISION) in the management of 100 patients with iT2N0M0 small low rectal cancer~     after Neoadjuvant Treatment.~   "
149509|NCT01609491|"~     In ophthalmic surgery the specific anaesthesiological challenges necessitate the~     administration of a combination of relatively high doses of hypnotics and analgetics. In~     order to preserve adequate organ perfusion, there is often a need to administer~     pharmacological agents for haemodynamic support. Depending on the experience of the~     anaesthetist a continuous infusion of phenylephrine or norepinephrine is used. It is~     currently not known which of these agents has the most favorable haemodynamical profile.~      Haemodynamic parameters (continuous blood pressure, cardiac index, stroke volume and systemic~     resistance), peripheral tissue oxygenation and cerebral tissue oxygenation will be monitored~     noninvasively using the Nexfin® , Inspectra®, and Foresight® and O2C® monitoring devices.~   "
149510|NCT01609478|"~     To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with~     persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.~   "
149511|NCT01609465|"~     There is currently no published algorithm for secondary prevention prognosis of CHD that is~     representative of the England GP-registered population and that includes both symptomatic and~     asymptomatic patients (as identified through primary care). In this paper the investigators~     will exploit routinely collected information in clinical practice to model CHD prognosis~     based on a large contemporary open cohort of stable CAD patients. Although the investigators~     model is based on data from GP practices in England only, the investigators believe that this~     population is sufficiently heterogeneous in terms of ethnic mix, socioeconomic background,~     predisposing characteristics and lifestyles to generate a prognostic model with good~     generalizing power to the wider population.~      Among the research questions the investigators will try to answer is whether established risk~     factors for primary care prevention (smoking, hypertension, dyslipidaemia, diabetes) are also~     reliable for risk-stratification of patients who have already developed CAD. Similarly, the~     investigators will examine whether strong predictors of adverse outcomes in ACS patients in~     the short term, such as admission SBP and heart rate, are also associated with their long~     term prognosis.~   "
149512|NCT01609452|"~     The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when~     administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura~     (ITP).~   "
149513|NCT01609439|"~     The purpose of this study is to determine if pre-operative vitamin D supplementation lowers~     the incidence of post-operative transient or permanent hypoparathyroidism in patients~     undergoing total thyroidectomy.~   "
149514|NCT01609426|"~     The primary purpose of the study is to identify the factors of steroid dependency in~     childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of~     nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the~     first manifestation. Different clinical and biological factors will be analyzed: age of first~     manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization~     in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes~     involved in the response to steroid therapy.~   "
149515|NCT01609413|"~     In a crossover, single blind, randomized trial the calcium bioavailability of two calcium~     supplements will be compared.That is AlgaeCal®(Algaecal Inc, Vancouver, Canada)(1 dose is 3~     capsules of 180 mg calcium), derived from ocean algae and the proprietary calcium supplement~     Caltrate 600® (Wyeth Consumer Healthcare, Inc).~      After a screening visits 20 healthy male subjects aged 20-50 years will spend a day at the~     research center to examine calcium bioavailability data. They will be randomized to consume~     either first the AlgaeCal® supplement or the Caltrate 600® supplement. After a one week~     wash-out period subjects will be supplemented with the other supplement. During the~     examination day blood and urine samples will be collected before and until eight hours after~     the supplementation for analyses of calcium, creatinine, phosphorus, albumin and 25 Hydroxy~     vitamin D. Subjects are instructed to avoid taking calcium and/or vitamin D supplements 1~     week before and during the entire study period. In addition, they are not allowed to take~     medication that may affect calcium metabolism.~      The hypothesis of the study is that calcium bioavailability of the AlgaeCal® supplement will~     be higher than that of the Caltrate 600® supplement.~   "
149516|NCT01609400|"~     The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term~     safety and evaluation if a satisfactory breast cancer screening can be performed in subjects~     treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also~     performed.~   "
149517|NCT01609387|"~     This study is a double blind randomized controlled trial.~   "
149518|NCT01609374|"~     This is a prospective, concurrently controlled, multi-center study to evaluate the safety and~     effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior~     cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy~     with or without cord compression. Some participating sites will enroll just M6-C patients,~     while others will enroll just ACDF patients.~      Patients eligible for study enrollment will present with degenerative cervical radiculopathy~     requiring surgical intervention, confirmed clinically and radiographically, at one vertebral~     level from C3 to C7.~      A total of 243 subjects will be included at up to 20 sites.~   "
149519|NCT01609361|"~     Rehabilitation program improves operative results following conventional open colorectal~     surgery. Very few data are available on such program in laparoscopic colorectal surgery.~   "
149520|NCT01609348|"~     This study will test the use of venlafaxine to treat the depression in Alzheimer's Disease.~     Venlafaxine works by increasing natural substances in the brain (serotonin and~     norepinephrine) that help maintain mental balance. Alzheimer's disease (AD) is the commonest~     neurodegenerative disease of aging and the cause of major financial and emotional burden to~     patients, families and caregivers, and society. Depression is a very common symptom of AD,~     affecting as many as 50% of patients over their illness. Depression in AD (Alzheimer's~     disease) contributes greatly to patient disability and caregiver distress. Neither~     psychosocial interventions nor psychotropic medications have proven effective to date for the~     treatment of depression in AD.Venlafaxine is approved by the U.S. Food and Drug~     Administration (FDA) for the treatment of major depression but it is not known whether or not~     it can help depression in Alzheimer's Disease.~   "
149863|NCT01604850|"~     This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin~     (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus~     (HCV) infection as assessed by the proportion of participants with sustained virologic~     response (SVR) 12 weeks after discontinuation of therapy (SVR12).~   "
149521|NCT01609335|"~     Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated~     diagnostic criteria for AD where their role is to identify the pathophysiological processes~     underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are~     brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to~     effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much~     be divided into normal and abnormal ranges. This requires that a cut point(s) be established~     in the continuous distribution of values for each biomarker.~      The investigators objective in this proposal is to obtain imaging biomarker data in a group~     of individuals who are appropriate for establishing normative values for AD biomarkers. The~     investigators believe the most valid approach to establishing biomarker cut points is to base~     them on the upper bound of the range observed in young to early-middle-age subjects in whom~     the presence of occult AD pathology is extremely unlikely. Based on a large volume of~     community-based autopsy data, that upper age limit would be about 50 years old. The lower age~     bound for a group of subjects used to establish normative AD biomarker values would have to~     be based on considerations of brain maturation, which may continue into the middle- to~     late-20s. Thus, taking the above into consideration, the ideal age range for establishing~     normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages~     30-49 years old.~   "
149522|NCT01609322|"~     This project aims to test the efficacy of an in-home intervention, Activity, Balance,~     Learning, and Exposure (ABLE), which integrates exposure therapy with cognitive~     restructuring, exercise, and home safety evaluation for older adults with excessive fear of~     falling. The intervention will be conducted by a licensed physical therapist. A control~     intervention will be conducted by a health educator. The specific aims of the study are to~     test the feasibility, acceptability, tolerability, and safety of the ABLE intervention.~   "
149523|NCT01609309|"~     -  Laparoscopic distal subtotal gastrectomy with lymph node dissection as minimally~          invasive surgery has gained popularity for the treatment of early gastric cancer in East~          Asian countries, even though the long-term follow-up outcome based on multicenter~          randomized clinical trial (RCT) is still awaited.~        -  For the patient with locally advanced gastric cancer, several studies indicated that~          laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically~          feasible and safe procedure by experienced surgeons in high-volume specialized~          hospitals. However, the application of it is controversial mainly due to lack of solid~          evidence on the oncologic efficacy. Therefore, conventional open approach is still the~          current standard for advanced gastric cancer.~        -  Nowadays, the proportion of patients with locally advanced gastric cancer is estimated~          up to 80 per cent of all gastric cancer cases in China. Before the clinical application~          of laparoscopic procedure for the treatment with curative intent to advanced gastric~          cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must~          be verified.~        -  Accordingly,the comparison of intraoperative and postoperative complications between~          laparoscopic and open distal subtotal gastrectomy for over 65 years old patients with~          gastric cancer based on a randomized controlled trial is needed.~   "
149524|NCT01609296|"~     The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug~     Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral~     and/or popliteal arteries in a real world patient population.~   "
149525|NCT01609283|"~     The purpose of this study is to determine determine the safety of intraspinal delivery of~     mesenchymal stem cells (MSCs) to the cerebral spinal fluid of patients with Amyotrophic~     Lateral Sclerosis (ALS) using a dose-escalation study.~   "
149526|NCT01609270|"~     Post-marketing surveillance registry of the CardioRoot graft.~   "
149527|NCT01609257|"~     The purpose of this study is to determine whether the norovirus vaccine is effective in~     preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge~     dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the~     vaccine.~   "
149528|NCT01609244|"~     Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with~     complex sleep apnea during continuous positive airway pressure (CPAP) treatment.~   "
149529|NCT01609231|"~     The purpose of this adaptive trial is to compare the progression-free survival of~     participants with metastatic rectal carcinoma when treated with dalotuzumab + irinotecan~     therapy relative to participants treated with cetuximab + irinotecan.~   "
149530|NCT01609218|"~     The study will evaluate effect of activated charcoal on absorption of LY2140023. The study~     involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth two times~     during study (once with activated charcoal, once without activated charcoal). This study will~     last approximately 16 days not including screening. Screening is required within 30 days~     prior to study entry.~   "
149531|NCT01609205|"~     The purpose is to study the relationship between RA disease activity based on Doppler~     quantification and the subsequent clinical response (EULAR response) to treatment with~     Adalimumab during 12 months. The purpose is also to compare the Doppler quantification with~     conventional clinical methods and semiquantitative Doppler assessment.~   "
149532|NCT01609192|"~     The project's background: Sickle cell disease is, at present in France, the most frequent~     genetic illness. Recent progress in its treatment, in particular the use of hydroxyurea, has~     considerably modified the prognosis of this disease. Many more patients now reach~     reproductive age and do consider fathering. Exceptional studies have reported the potential~     impact of this medical treatment on the sperm parameters and fertility of male patients. In a~     retrospective analysis, the investigators found that the observed alterations of semen~     parameters due to sickle cell disease seem to be exacerbated by hydroxyurea treatment.~      The study hypothesis: A large prospective study is essential to assess the potential adverse~     impact of the medical treatment of sickle cell disease on spermatogenesis and consider the~     advisability of proposing sperm cryopreservation before this treatment is started.~      Primary purpose of the protocol: evaluate the impact of a treatment by hydroxyurea (20-30~     mg/kg/day), 6 months after its beginning, in 34 men with sickle cell disease (18-60 years~     old). The main trial criterion will be the average difference of the concentration of~     spermatozoa s (millions/ml) in the ejaculate, before and after 6 months of medical treatment.~   "
149533|NCT01609179|"~     A treatment protocol that enables patients to have continued access to IPI-926.~   "
149534|NCT01609166|"~     Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective~     preventative treatment has been definitively demonstrated. This trial is conducted on the~     basis of preliminary data that a 3% allopurinol-based topical agent may prevent HFS.~      A randomized, double-blind phase III trial will evaluate 40 patients receiving their first~     ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days.~     Patients will be randomly assigned to a 3% allopurinol versus a placebo cream, which will be~     applied to the hands and feet twice per day for 6 months after the start of capecitabine.~     Patients will be examined every month and the investigators will take some photographs of~     hands and feet. HFS toxicity grade (Common Terminology Criteria for Adverse Events~     [CTCAE]v3.0) will be also collected at baseline and at the end of each cycle. The primary end~     point is the incidence of moderate/severe HFS symptoms at the end of capecitabine treatment ,~     based on the patient-reported dermatological exploration.~   "
149535|NCT01609153|"~     A study to examine whether an antipsychotic combination treatment of olanzapine and~     amisulpride is more effective than olanzapine and amisulpride alone.~   "
149536|NCT01609140|"~     The purpose of this study is to evaluate the safety and cholesterol lowering effects of~     MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a~     high risk of cardiovascular events and LDL-c levels well above goal.~   "
149537|NCT01609127|"~     This study is being conducted to compare the efficacy and safety of tesetaxel administered~     once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive~     weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in~     a 21-day cycle.~   "
149538|NCT01609114|"~     The concurrent use of chemotherapy during radiation therapy (CCRT) is now the important~     treatment stratagem for locally advanced head and neck cancer or nasopharyngeal cancer (NPC).~     For these cases, 5-Fluorouracil (5-FU) and cisplatin (CDDP) are the most commonly used agents~     of CCRT. It plays an important role to improve the treatment outcome and increases the~     opportunities for organ preservation.~      In the past, Radiotherapy (RT) was solely used as a local treatment and its effect was~     estimated by local effect model. However, growing evidence shows that irradiation has direct~     DNA damage-dependent effects as well as sending signals to neighboring cells. Recently, the~     investigators reported that abdominal irradiation could significantly modulate the systemic~     pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the~     daily treatment dose for target treatment in an experimental rat model. Additionally, the~     results from a clinical investigation showed that colorectal cancer patients with lower AUC~     of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these~     lines of evidence support the importance and necessity to search for the mediators~     responsible for the unexpected effect of local RT on systemic pharmacokinetics of~     chemotherapeutic agents, such as 5-FU.~      In the present study, the investigators examined whether the phenomena and mechanism of~     RT-PK(pharmacokinetics) is a fact for different anticancer drugs and for different part in~     human.~   "
149539|NCT01609101|"~     In this randomised crossover trial we measure the space between the right side of the~     laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients with~     a normal mouth opening. We compare the remaining spaces for seven different~     videolaryngoscopes and compare these to a classic Macintosh laryngoscope.~   "
149540|NCT01609088|"~     The study will determine whether acute and chronic consumption of a beverage containing~     erythritol will improve endothelial function in patients with type 2 diabetes mellitus.~   "
149541|NCT01609075|"~     This observational, multicenter, retrospective/prospective study will evaluate the use of~     Avastin (bevacizumab) in clinical practice in patients with metastatic colorectal cancer.~     Patients having initiated first-line treatment with a fluoropyrimidine-based chemotherapy and~     Avastin will be followed for up to 15 months.~   "
149542|NCT01609062|"~     The primary objective of this study was to evaluate the safety of a 2.0 mg/kg/week and a 4.0~     mg/kg/week of BMN 110 in patients with Morquio A syndrome for up to 196 weeks. Secondary~     objectives were to investigate the effect of the two doses on exercise capacity for up to 196~     weeks. In addition, the pharmacokinetic (PK) parameters of both doses of BMN 110 was~     assessed.~   "
149543|NCT01609049|"~     This prospective observational study will evaluate the efficacy and safety of peginterferon~     alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including~     participants with compensated liver cirrhosis, in clinical practice.~   "
149544|NCT01609036|"~     This observational study will evaluate the safety and efficacy of MabThera/Rituxan~     (rituximab) in previously untreated patients with follicular lymphoma. Data will be collected~     for 3 years~   "
149545|NCT01609023|"~     This observational study will evaluate the safety and efficacy of rituximab in combination~     with chemotherapy in first- and second-line treatment of participants with cluster of~     differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be~     collected from eligible participants receiving rituximab according to the Summary of Product~     Characteristics (SPC) during 6 months of treatment.~   "
149546|NCT01609010|"~     This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan~     (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with~     follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either~     MabThera/Rituxan 375 mg/m2 intravenously weekly for 4 weeks or Roferon-A 3 MIU/day~     subcutaneously in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 plus MabThera/Rituxan 375~     mg/m2 weekly iv in Weeks 3-6. Patients who have a response will receive an additional cycle~     of treatment. The anticipated time on study treatment is up to 6 months.~   "
149547|NCT01608997|"~     Rotator cuff tears are common amongst 50-60 year olds with no connection to their physical~     activity. When symptomatic, the injury affects all aspects of general health, quality of life~     and function. Surgical intervention is recommended only if conservative treatment fails. The~     purpose of the surgical intervention is to reduce pain, and improve function while improving~     range of motion and muscle strength around the shoulder. The purpose of the current study is~     to measure physical, functional, expectation, satisfaction and quality of life outcomes after~     rotator cuff repair surgery. Another purpose is to learn the reproducibility components of~     the above outcomes.~   "
149888|NCT01604525|"~     The RealU2 is a randomized controlled trial to determine the efficacy of an online health and~     wellness program for young adults with the addition of individualized peer health coaching.~   "
149548|NCT01608984|"~     Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces~     myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with~     cross-clamp fibrillation or blood cardioplegia for myocardial protection. The molecular~     mechanisms leading to these effects are yet not fully understood. The purpose of the present~     study is to validate previous studies and gather further evidence for RIPC during CABG with~     blood cardioplegia, furthermore to determine, whether or not RIPC is still operative during~     Off-pump coronary artery bypass surgery (OPCAB), finally to elucidate intra-cellular~     mechanisms involved in myocardial protection by RIPC and their possible systemic mediators.~   "
149549|NCT01608971|"~     Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of~     heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies~     suggest that an overdose of protamine has anticoagulant effects which might lead to bleeding~     complications. Heparin levels usually decrease during cardiac surgery with CPB. Therefore, a~     protamine regimen based on the initial heparin dose before CPB might lead to overdose of~     protamine. In contrast, a protamine regimen based on the actual heparin concentration may~     avoid this condition. The investigators compare both regimens of protamine dosing in patients~     undergoing complex surgery with CPB and assess its effect on the amount of protamine given,~     markers of the coagulation system, utilization of blood products and perioperative blood~     loss.~   "
149550|NCT01608958|"~     The study will evaluate whether prophylactic oxytocin administered in the third stage of~     labor via IV infusion results in a lower mean blood loss compared to IM injection.~   "
149551|NCT01608945|"~     The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with~     impairment of liver function. Perioperative steroid administration has been advocated to~     reduce liver damage. The aim of this prospective, randomized study was to determine whether~     steroid administration can reduce liver injury and impact the prognosis~   "
149552|NCT01608932|"~     The purpose of this study is to evaluate whether telemonitoring of frail patients with~     chronic diseases produces benefits in terms of reduced readmissions, improved health related~     quality of life, and improved health status. In addition, the trial evaluates the economic~     and organisational impact of the telemonitoring service and examines its acceptability by~     patients and health professionals.~   "
149553|NCT01608919|"~     This study plans to learn more about the role of 2 blood tests in predicting who might~     develop a blood clot in their arm or leg after major surgery. The investigators know that~     patients who have cancer and major surgery have a higher than normal risk of getting blood~     clots in the veins of their arms or legs. This can be very dangerous because the clot can~     move into your lungs.~   "
149554|NCT01608906|"~     This study plans to learn more about what is the best treatment to prevent blood clots in~     patients in intensive care units (ICU's). The investigators know that patients who are in~     ICU's have a higher than normal risk of getting blood clots in the veins of their arms or~     legs. This can be very dangerous as the clot may move into the lungs. To prevent this, the~     standard treatment is to give low dose heparin subcutaneously 3 times a day (usually 5000~     units at each dose). In this study the investigators are randomizing patients to receive~     either standard of care or low dose intravenous heparin in a continuous infusion.~   "
149555|NCT01608893|"~     Atrial fibrillation (AF) is the most common sustained heart rhythm disorder and is associated~     with significant symptoms and health problems including an increased risk of stroke and~     death. Current drug therapies are often ineffective and associated with significant side~     effects. Abnormalities of calcium regulation in cells may lead to triggers for AF. Emerging~     data suggest that abnormal intracellular calcium regulation mediated through the ryanodine~     receptor in heart cells may contribute to AF. Recently the investigators have shown that the~     β-blocker carvedilol which is most commonly used to treat patients with heart failure,~     modifies calcium regulation mediated through the ryanodine receptor. At present this drug is~     not frequently used to treat AF. Therefore the investigators will conduct a randomized trial~     comparing carvedilol to metoprolol for prevention of paroxysmal AF. This may result in~     improved health and quality of life for people who suffer AF.~   "
149556|NCT01608880|"~     Background:~      Mastectomy flap necrosis (MFN) is a common complication that affects recovery, reconstructive~     success and aesthetic outcome. Nitroglycerin (NTG) ointment is a potent topical vasodilator~     that increases local blood flow by dilating arteries and veins without altering the ratio of~     pre- to post-capillary resistance. There are no studies that evaluate whether the application~     of NTG ointment in patients undergoing Skin-sparing mastectomy (SSM) or nipple-sparing~     mastectomy (NSM) and immediate reconstruction decreases the rate of mastectomy flap necrosis.~      Objective:~      To evaluate if the post-operative application of NTG ointment improve rates of MFN in~     patients undergoing SSM or NSM with immediate breast reconstruction compared to patients~     receiving placebo.~      Hypothesis:~      In patients undergoing SSM and immediate breast reconstruction there will be a decrease in~     the rate of MFN in those who receive NTG ointment compared to those who receive placebo.~   "
149567|NCT01608737|"~     The objectives of this study are:~        1. To evaluate the efficacy and safety of two different treatment regimens with BI 201335~          (high dose given for 12 weeks or low dose given for 24 weeks both in combination with~          Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in~          treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients.~        2. Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in~          combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in~          chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV~          treatment.~   "
149568|NCT01608724|"~     The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with~     type 2 diabetes mellitus.~   "
149569|NCT01608711|"~     The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4~     administered in combination with gemcitabine in subjects previously treated in protocol~     2008002.~   "
149570|NCT01608698|"~     The purpose of this study is to evaluate different side effect in contraceptive use of two~     oral combined contraceptive pills (OCP)in combination of 30 mcg ethinylestradiol/2 mg~     chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®),~     especially body weight change.~   "
165205|NCT01403311|"~     This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in~     removing malignant brain tumors during surgery.~   "
149557|NCT01608867|"~     This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid~     tumor for which there is no remaining standard curative therapy. Subjects will be assessed~     for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim~     analyses will be performed.~      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon~     enrollment, subjects will receive OMP-54F28 until disease progression. All subjects will~     receive Vitamin D3 daily and calcium carbonate twice daily from Day 0 through 30 days~     following the discontinuation of OMP-54F28.~      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). Subjects~     will be dosed at 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks. No dose~     escalation or reduction will be allowed within a dose cohort. Intermediate doses (i.e., doses~     between the dose levels listed above) may also be tested upon agreement with the~     investigators and the study sponsor. In addition, alternate dosing schedule cohorts of~     OMP-54F28 (eg. every 4 week or every 6 week dosing) can be studied upon agreement with the~     investigators and the study sponsor. These alternative less frequent dosing schedules may be~     evaluated if emerging data suggest that once every 3 week dosing results in tolerability~     concerns. The first 2 subjects enrolled in a cohort will not be treated on the same day. The~     dose may be administered at any time during the day. Three subjects will be treated at each~     dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences~     a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a~     DLT, no further subjects will be dosed at that level and 3 additional subjects will be added~     to the preceding dose cohort unless 6 subjects have already been treated at that dose level.~     Subjects will be assessed for DLTs from Days 0-28. Dose escalation for newly enrolled~     subjects, if appropriate, will occur after all subjects in a cohort have completed their Day~     28 DLT assessment. Subjects who have a >2-fold increase of their fasting β-CTX or a decline~     of >3% in their bone mineral density (BMD) from screening or a T-score decline to <-2.5 in~     the total femur or L1-L4 DEXA scan measurement will be started on zoledronic acid. Subjects~     with stable disease or a response at Day 56 will be allowed to continue to receive OMP-54F28~     until disease progression. An additional 6 subjects will be enrolled in an expansion cohort~     at the highest dose level that results in <2 of the 6 subjects experiencing a Grade 3 (not~     including a Grade 3 infusion reaction that resolves in 24 hours) or Grade 4 adverse event~     (DLT). Tumors of particular interest for inclusion in the expansion cohort include sarcomas,~     basal cell carcinoma, ovarian cancer, desmoid tumors and prostate cancer given the known~     importance of the Wnt pathway in these malignancies.~   "
149558|NCT01608854|"~     In spine surgery, postoperative spinal drains are often utilized to prevent fluid buildup~     around the spinal cord. The purpose of this study is to determine whether postoperative~     antibiotic treatment continued for the duration of time a drain is in place results in a~     lower infection rate than antibiotics given for only 24 hours postoperatively.~   "
149559|NCT01608841|"~     The purpose of this study is to investigate the influence of epidermal growth factor receptor~     mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.~   "
149560|NCT01608828|"~     Studies suggest that strabismus has a negative impact on a person's self-image, interpersonal~     relationships, emotional and psychosocial state (4-15). There are, however, few such studies~     based in Asia, and the functional and psycho-social impact of disease is often neglected in~     our management of strabismus in Singapore. The aim of this pilot study is to measure~     quality-of-life (QOL) among strabismic children in Singapore so as to better understand the~     functional and psychosocial issues faced by these children in their daily living. The~     investigators also hope to evaluate the performance of the Intermittent Exotropia~     Questionnaire (IXTQ) (2) and Adult Strabismus Quality of Life Questionnaire (AS-20) (1) and~     to determine if differences between child and parental perceptions exist.~      60 children with strabismus presenting to the KKWCH Eye Centre and their parents will be~     invited to participate in the study and answer questions in 2 Pediatric Eye Disease~     Investigator Group (PEDIG)-validated questionnaires (i.e. the IXTQ and AS-20). 30 children~     aged 5-7 years will answer the 12-question IXTQ (5-7 years), while 30 children aged 8-16~     years will answer the 12-question IXTQ (8-16 years) and the 20-question AS-20 questionnaires.~     Their parents will answer the self-administered IXTQ child-proxy (12 questions), IXTQ~     parental (17 questions) and modified AS20 child-proxy questionnaires (20 questions). For~     comparison, 60 aged-matched children without strabismus or amblyopia (30 aged 5-7 years, and~     30 aged 8-16) and their parents will also be invited to answer similar questionnaires~     (controls).~      Results will be analysed question-by-question and then by composite score, and comparison~     will be made between child and parental-proxy measures, as well as with scores obtained from~     myopic children. It is hoped, that from this study, we will be able to assess the usefulness~     of the IXTQ and AS-20 instruments as measures of QOL in strabismic children, and to assess~     the feasibility of its use in a larger study looking at the impact of strabismus and its~     treatment in Singaporean children.~   "
149561|NCT01608815|"~     This study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide~     vaccine in Japanese participants to support registration of the product in Japan.~      Primary Objective:~      To describe the seroconversion rate (percentage of subjects with at least a 4-fold increase~     of their Vi antibody titer) between Day 0 before vaccination and Day 28 after vaccination~     with typhoid Vi polysaccharide (SP093) vaccine in subjects aged 2 years and above.~      Secondary Objectives:~        -  To describe the safety profile of a single dose of typhoid Vi polysaccharide vaccine up~          to 28 days after vaccination, in subjects aged 2 years and above.~        -  To describe the immune response following a single dose of typhoid Vi polysaccharide~          vaccine in subjects aged 2 years and above.~   "
149562|NCT01608802|"~     Despite overwhelming need for effective HIV palliative care in sub-Saharan Africa, a~     systematic appraisal of the literature found almost no outcome or evaluative evidence.~      Aim:~      The investigators aim to evaluate the efficacy of HIV palliative care training and a simple~     palliative care assessment tool provided to nurses of patients on Antiretroviral Therapy~     (ART), and to evaluate this in terms of patient outcomes under clinical experimental~     conditions in 2 African countries using randomised controlled trial (RCT) designs.~      Intervention being tested:~      Within each well-established HIV ART clinic, patients will be randomly allocated to either~     continue receiving standard care (control group) or to receive standard care plus~     appointments with a clinic nurse trained in basic palliative care (intervention group).~      Methods:~      Design: Each Phase III clinical trial (i.e. one trial in each of 2 countries) will be powered~     and conducted in parallel to a common research design protocol, thus permitting evidence of~     outcomes that reflects 2 different ART providers, providing evidence of palliative care~     efficacy relevant to different HIV care settings.~      Primary outcome: Each trial has been powered to a primary endpoint of pain control.~      Secondary outcomes: The secondary outcomes are the core domains of palliative care as defined~     by the WHO (i.e. physical, including symptoms, psychological, social and spiritual) and~     measured by the APCA African POS. Further secondary outcomes measured will be: adherence to~     treatment; risk behaviours; health-related quality of life; psychological morbidity.~      Inclusion: Patients will be screened and invited into the trial if they are on ART, score 3-5~     on the 0-5 APCA African POS pain or symptom items, are 18 years or older, and can give~     informed consent to trial entry and data collection.~      Analysis: An intention-to-treat analysis will be conducted to determine treatment response~     differences between the two conditions. In order to maximise the efficiency of longitudinal~     data, multi-level modelling will be applied as appropriate.~   "
149563|NCT01608789|"~     This study is a prospective, single arm, non-randomized, multi-center clinical study that~     will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male~     Sling in post-prostatectomy urinary incontinence.~   "
149564|NCT01608776|"~     To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care~     (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).~   "
149565|NCT01608763|"~     The major objective of this project is to conduct a randomized controlled trial comparing the~     impact of the normative feedback and other personalized feedback components of the Check Your~     Drinking (CYD) Internet-based intervention in the general population. Eligible problem~     drinking participants will be randomly assigned to one of four conditions in a 2 by 2 design~     - to receive just the normative feedback component of the CYD intervention, just the other~     personalized feedback information, to a no intervention control condition, or to receive the~     full CYD intervention. The no intervention control condition will not be sent any~     intervention materials but will instead be sent a list of the different components of the CYD~     feedback and will be asked to think about how useful they would find each of them. All~     participants will be followed-up at 3 months.~   "
149571|NCT01608685|"~     Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for~     the detection of tuberculosis (latent or active infection) than the tuberculin skin test~     (TST) in immunocompetent individuals. However, very little data are available concerning the~     relative performance of IGRA and TST in immunosuppressed individuals from other causes than~     HIV.~      The investigators hypothesize that IGRAs would be more sensitive and specific than the TST in~     a group of renal transplant recipients under chronic immunosuppressive treatment for~     detecting latent tuberculosis infection.~   "
149572|NCT01608672|"~     This is an observational study assessing patient satisfaction following at least 5 years of~     BOTOX® treatment for glabellar lines.~   "
149573|NCT01608659|"~     This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A~     for the treatment of facial lines.~   "
149574|NCT01608646|"~     In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin~     chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.~   "
149575|NCT01608633|"~     Pain after dry needling or injection in the muscle is a frequent secondary effect in the~     treatment of myofascial pain syndrome. In this trial spray and stretch technique is evaluated~     as a method to reduce this soreness. As well, the characteristics and the different factors~     that influence in this pain will be described.~   "
149576|NCT01608620|"~     Since uncontrolled observational studies first linked fructose to the epidemic of obesity~     almost a decade ago, it has become a focus of intense concern regarding its role in the~     obesity epidemic and increasing burden of cardiometabolic disease. Despite the uncertainties~     in the evidence, international health organizations have cautioned against moderate to high~     intakes fructose-containing sugars, especially those from sugar sweetened beverages (SSBs).~     To improve the evidence on which nutrition recommendations are based, the investigators~     propose to study of the role of fructose-containing sugars in the development of~     overweight/obesity, diabetes, hypertension, gout, and cardiovascular disease, by undertaking~     a series of systematic syntheses of the available prospective cohort studies. Prospective~     cohort studies have the advantage of relating real world intakes of sugars to clinically~     meaningful disease endpoints over long durations of follow-up. The findings generated by this~     proposed knowledge synthesis will help improve the health of consumers through informing~     recommendations for the general public, as well as those at risk of diabetes and~     cardiovascular disease.~   "
149577|NCT01608607|"~     Since uncontrolled observational studies first linked fructose to the epidemic of obesity~     almost a decade ago, it has become a focus of intense concern regarding its role in the~     obesity epidemic. Despite the uncertainties in the evidence,the recommendations of~     international health organizations have cautioned against moderate to high intakes~     fructose-containing sugars, especially those from sugar sweetened beverages (SSBs). To~     improve the evidence on which nutrition recommendations are based, the investigators propose~     to study of the effect of fructose-containing sugar sweetened beverages (SSBs)on body weight,~     by undertaking a systematic synthesis of the data taken from all available clinical studies~     in humans. This technique has the strength of allowing all of the available data to be pooled~     together and differences to be explored in groups of different study participants (healthy~     humans of different sex, weight, and age and in those with diseases which predispose to~     disturbances in metabolism, such as diabetes) with dietary fructose in different forms,~     doses, and with differing durations of exposure. The findings generated by this proposed~     knowledge synthesis will help improve the health of consumers through informing~     recommendations for the general public, as well as those at risk of diabetes and~     cardiovascular disease.~   "
149578|NCT01608594|"~     The purpose of this study is to evaluate the safety and potential effectiveness of a new~     treatment for advanced and recurrent melanoma involving the combination of Ipilimumab and~     IFN-α2b before surgery and to test for biomarker studies in blood and/or tumor to better~     understand this disease, how best to treat it and what patients should be treated with this~     combination.~   "
149579|NCT01608581|"~     The aim of this study was to evaluate the effectiveness of a targeted burn prevention message~     on burn safety knowledge and behavior.~   "
149580|NCT01608568|"~     1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh~     attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique~     using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech~     Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed~     delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      1.2 SECONDARY OBJECTIVE - To compare robotic assisted laparoscopic sacrocolpopexy anatomic~     failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed~     absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0~     non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The~     investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates.~      2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with~     self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals,~     Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using~     0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1~     barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver,~     Canada) will be less costly than the standard fixation interrupted technique using 0~     non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.~      2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based~     on subjective surgeon satisfaction questionnaires.~   "
149581|NCT01608555|"~     The study will include 10 adult patients with cystic fibrosis. The aim of the study is to~     evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial~     load in the airways. Secondary end-point is the evaluation of variation in bacterial~     susceptibility during and at the end of study period.~   "
149582|NCT01608542|"~     This is a single and multiple dose study in healthy male and female (of non-child bearing~     potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib.~     Fostamatinib is being developed for the treatment of rheumatoid arthritis.~   "
149584|NCT01608516|"~     The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection~     of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI~     and US and to determine the contribution of each imaging technique. Current gold standard for~     inflammation is histopathology.~      Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with~     atheromatous plaques in the carotid artery eligible for endarterectomy.~   "
149585|NCT01608503|"~     The subclavian vein (SCV) is a preferred site for placement of central venous catheter.~     However, pneumothorax is a major concern during subclavian venous catheterization. Lung~     deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the~     distance between the pleura and the SCV. The investigators evaluated the effect of lung~     deflation on the relative position between the pleura and the line of the imaginary needle~     pathway during supraclavicular and infraclavicular approach to the subclavian vein (SCV)~     using ultrasonography.~   "
149586|NCT01608490|"~     Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the~     PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System~   "
149587|NCT01608477|"~     Over the past decades, survival rates in heart transplantation recipients improved~     significantly, due to advancements in regimens of immunosuppressives and surgical techniques,~     but are still limited to the first 12 months post transplantation. Long-term survival remains~     almost unchanged indicating the need to identify and improve relevant factors. Evidence in~     other chronically-ill patient populations shows that the healthcare system (e.g. level of~     chronic illness management (CIM)) and patient self-management (e.g. adherence) drive~     improvements in outcomes.~      The BRIGHT study is the first multi-centre, multi-continental study examining healthcare~     system and heart transplant centres chronic illness management practice patterns and~     potential correlates of immunosuppressive medication nonadherence.~      The knowledge gained will inform clinicians, researchers and healthcare policy makers about~     the level(s) interventions need to be implemented at to improve long-term outcomes for~     transplant recipients.~   "
149588|NCT01608464|"~     The purpose of this study is to improve their outcome by either changing the chemotherapy~     drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will~     improve their outcome.~   "
149589|NCT01608451|"~     Randomized Controlled Trial of Neoadjuvant Progesterone and Vitamin D3 in women with Large~     Operable Breast Cancer and Locally Advanced Breast Cancer - A Feasibility Study~      Primary Progesterone Timing of surgery during the menstrual cycle and its impact on survival~     in premenopausal women with operable breast cancer has been extensively researched and~     reinvestigated by Badwe et al in the randomized clinical trial of 'Primary Progesterone~     Therapy for Operable Breast Cancer' at Tata Memorial Hospital. The underlying assumption was~     that the presence of unopposed estrogen (in follicular phase) at the time surgery may be~     deleterious for survival and that circulating progesterone might counteract this deleterious~     effect.~      Vitamin D3 The most prominent physiological role of hormonally active form of vitamin D3,~     1,25-dihydroxyvitamin D3 (1,25(OH)2D3 or calcitriol), is regulation of calcium and~     phosphorous homeostasis and bone metabolism via an intracellular receptor (VDR) which is a~     member of steroid thyroid hormone super-family of receptors. The VDR receptors are also found~     in other tissues like breast and prostate.~      Vitamin D compounds have also been implicated in promotion of apoptosis in breast cancer~     cells and evidence suggests that 1,25(OH)2D3 and its synthetic analogues may potentiate~     responsiveness of breast cancer cells to conventional cytotoxic agents.~      Objectives~        1. To see the effect of primary progesterone on survival in women with high risk breast~          cancer (large operable and locally advanced breast cancer)~        2. To see the effect of Vitamin D3 as an antiproliferative, cytotoxic and apoptotic agent~          (negative growth regulator) by evaluation of surrogate markers of proliferation and~          apoptosis.~      Inclusion Criteria:~        -  Unilateral breast cancer~        -  Large operable breast cancer/LOBC (T3N0M0 or T3N1M0) and Locally advanced breast~          cancer/LABC (T3N1-2M0; T2N2M0)~        -  Age <70 years~        -  Fit for CT~      Exclusion Criteria:~        -  Prior Incision Biopsy or Excision Biopsy~        -  Metastatic breast cancer~        -  Renal failure or deranged Renal Function Test~        -  Hypoparathyroidism~        -  Pregnant or lactating mothers or women of childbearing age not practicing contraception~        -  Patient on any of the following drugs: Magnesium-containing antacids, Digitalis,~          Phenytoin barbiturates, Thiazide diuretics.~        -  Previous history of other cancers except cured skin and cervical carcinoma in situ.~      Methodology / Treatment plan~      The study drugs (Injectable Progesterone and Vitamin D3) will be tested in the neoadjuvant~     setting prior to administration of each chemotherapy cycle, in a 2x2 factorial design as~     below:~      Neoadjuvant D3 will be administered as Inj. Arachitol 300,000 IU/ml intramuscular, before~     each chemotherapy cycle.~      Neoadjuvant Progesterone used will be administered as single IM depot injection 500mg 5 days~     prior to each CT cycle and surgery date.~      Primary Objectives Disease-free survival~      Secondary Objectives Improvements in overall survival Tumor response~   "
149590|NCT01608438|"~     People with tetraplegia often retain some level of mobility of the upper body. The proposed~     study will test the hypothesis that it is possible to develop personalized interfaces, which~     utilize the residual mobility to enable paralyzed persons to control computers, wheelchairs~     and other assistive devices. If successful the project will result into the establishment of~     a new family of human-machine interfaces based on wearable sensors that adapt their functions~     to their users' abilities.~   "
149591|NCT01608425|"~     Telemedicine technology enables a direct and online text- and image communication in the~     treatment system from patient to the ulcer specialist. The technology is expected to have~     patient-related, economic and therapeutic benefits. The study is a substudy of a larger~     project entitled Renewing Health, where also the economic and management aspects are~     highlighted. However, only few randomized prospective studies are conducted in this field.~     The purpose of the study is in a randomized prospective study, to assess the impact of the~     introduction of the telemedicine technology as consultation form between ulcer-nurses in the~     primary sector and the wound clinics at the hospitals in the region. It is assessed whether~     the technology can be adopted without incurring the patient a risk. The study aims to perform~     an impact analysis of the introduction of new technologies for telemedicine wound monitoring~     in the treatment of diabetic foot ulcers through different studies.~   "
149592|NCT01608412|"~     The study hypotheses to be tested in this study are:~        -  Conversion to everolimus at 3 months post-transplantation is safe and effective;~        -  Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months~          pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection,~          tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant~          recipients;~        -  Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can~          be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant~          recipients.~   "
149593|NCT01608399|"~     The main aim of this study is to (1) evaluate the effectiveness of metacognitive therapy for~     major depressive disorder. Additional aims are to (2) investigate patterns of change and the~     mechanisms of action involved during treatment, and to (3) examine the impact of~     meta-cognitions in the treatment and relapse prevention of depression.~   "
149594|NCT01608386|"~     Anterior approach results in better operative and survival outcomes compared with the~     conventional approach in patients with large hepatocellular carcinoma (HCC), but anterior~     approach has the problem of bleeding from the hepatic vein.~      Our previous study showed that infrahepatic inferior vena cava (IVC) clamping can reduce~     blood loss during conventional hepatic resection. The investigators guess infrahepatic IVC~     clamping may also reduce blood loss in anterior approach right hepatic resection. So the~     investigators conduct this prospective, randomized, controlled trial to compare anterior~     approach combined with infrahepatic IVC clamping and anterior approach in major right~     hepatectomy for large HCC.~   "
149595|NCT01608373|"~     This prospective randomized study aims to comparison the effectiveness of intravenous~     lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in~     patients undergoing laparoscopic cholecystectomy.~      A total of 83 patients will be randomized into one of three groups (group C or group I or~     group P) based on Excel number generation.~      Patients in group C will receive normal saline intravenous injection, and patients in group I~     will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous~     lidocaine infusion of 2 mg/kg/hr.~      Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg~     lidocaine and normal saline 100cc.~      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients~     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4, 8,~     12, 24, 48 hours postoperatively.~   "
149811|NCT01605539|"~     Despite the current available therapies for opioid-dependent patients, most patients relapse.~     This research project focuses on the development of a novel compound, cannabidiol, to~     modulate opioid craving in humans based on animal models showing its selective effectiveness~     to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse~     would be of tremendous medical and public health value.~   "
149596|NCT01608360|"~     This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine~     injection on the relief of pain in patients undergoing thyroidectomy.~      A total 56 patients will be randomized into one of two groups(group C or group I) based on~     Excel number generation.~      Patients in group C will receive normal saline intravenous injection, and patients in group I~     will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous~     lidocaine infusion of 2mg/kg/hr.~      Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients~     pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of~     nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.~   "
149597|NCT01608347|"~     Recurrent miscarriage (RM) is traditionally defined as three or more consecutive miscarriages~     occurring before 20 weeks post-menstruation. It is one of the most common clinical problems~     in reproduction, yet a definite cause can be established in only 50 percent of cases (ACOG~     practice bulletin, 2002). Many etiological factors have been proposed but none of them has~     been fully substantiated. RM has been directly associated with maternal thrombophilic~     disorders, parental chromosomal anomalies, and structural uterine anomalies and indirectly~     with maternal immune dysfunction and endocrine abnormalities.~      The association between pregnancy loss and antiphospholipid antibodies (aPL) was first~     noticed in the latter third of the last century. The antiphospholipid syndrome (APS) is~     characterized by the presence of antiphospholipid antibodies (APLA), associated with venous~     and/or arterial thrombosis, and/or pregnancy loss. The adverse pregnancy outcomes associated~     with the presence of APLAs include: recurrent fetal loss, intrauterine growth restriction~     (IUGR), and severe pre-eclampsia especially of early onset.~      Testing the effect of Heparin in treatment of cases with RA but negative for APA has bee done~     in few animal and clinical studies. Animal studies showed that the subset of cases with~     disorders suspicious for APS but who had negative test results for LAC and aCL is carrying~     antibodies pathogenic to murine pregnancy. Testing other immunoglobulin G may provide~     additional means to identify cases with an yet uncharacterized immune condition. Moreover,~     the clinical relevance of low levels of APLA in these women remains unproved.~      Randomized prospective study was done to assess the efficacy of early thromboprophylaxis of~     Low molecular weight heparin (LMWH) (Enoxaparin sodium 20 mg, once daily subcutaneously) in~     women with a history of recurrent miscarriages without identifiable causes versus no~     treatment. The results showed that, there is a significant reduction in the incidence of both~     early and late miscarriages (8.8% vs 4.1%) (2.3% versus 1.1%) with or without treatment,~     respectively.~      Cochrane Database systemic review (2005) shows randomized comparative studies for treating~     recurrent miscarriage in women without antiphospholipid syndrome. The first group treated by~     low dose aspirin alone and the second group treated by low dose aspirin + LMWH. The result of~     these studies shows that no significant differences between the two groups and identify the~     need of large randomized controlled trial to solve this problem.~      The above evidence suggests the probability of presence of untested LAC and aCL or very low~     levels of APLA by commonly used methods in women with recurrent miscarriage. These antibodies~     may explain recurrent miscarriage in cases with negative antiphospholipid antibodies. It~     remains to test the efficacy of heparin (proven effective treatment in those with positive~     antibodies) in the patients with negative antibodies. Finding a solution to this frustrating~     problem may open the way for an unsolved problem.~      The proposed study is an open labeled randomized controlled trial (RCT) To evaluate the~     effect of LMWH versus no heparin in treatment of recurrent miscarriage that is negative for~     antiphospholipid antibodies testing.~   "
149598|NCT01608334|"~     Adequate sensory block for surgical procedure without side effects and immediate mobilization~     after surgery are desirable anesthetic technique in various surgeries. Considering the~     sensory innervations to the prostate, a sensory block up to L1 - T12 is adequate to the TURP.~     Low-dose intrathecal local anesthetics may meet these criteria, but occasional lack of~     sufficient sensory block could be troublesome. In this randomized study, the investigators~     evaluated the spinal anesthetic characteristics following intrathecal administration of~     bupivacaine 1 mg with fentanyl or sufentanil in elderly patients undergoing TURP.~   "
149599|NCT01608321|"~     This study was designed to evaluate the effect of repetitive Transcranial Magnetic~     Stimulation (rTMS) in the resolution of Chronic Pain. Participants will be Veterans from the~     first Gulf War (GW1) who often suffer from chronic pain problems.~   "
149600|NCT01608308|"~     The purpose of this study is to assess the use of IV acetaminophen (Ofirmev) as a and safe~     and efficacious agent in reducing post-operative pain; we hypothesize that its use will~     reduce post-operative pain when compared to a control group using the visual analogue score~     (VAS) analog pain scoring system.~   "
149601|NCT01608295|"~     The purpose of this study is to examine the effects of vilazodone for the treatment of~     depression in older adults.~   "
149602|NCT01608282|"~     OPEN (Osteoarthritis Physical Activity and Exercise Net) is a website created based on a well~     developed behavioural theory. This intervention is developed for people with early knee~     osteoarthritis (OA) who have been sedentary. The investigators aim to engage these~     individuals to become physically active at a time when their joint symptoms tend to be mild.~     The primary goal of this proof-of-concept randomized controlled trial is to determine if the~     OPEN website plus an information pamphlet about OA will improve participation in physical~     activity in persons with early knee OA, compared to those who receive only the pamphlet.~   "
149603|NCT01608269|"~     The purpose of this study is to assess the safety, tolerability, and antivira activity of~     Epzicom in virologically controlled HIV subjects.~   "
149604|NCT01608256|"~     The Purpose of this study is to assess the effect of MCI on driving ability by using on road~     driving test. The relationship between their driving outcome and their cognitive decline will~     be examined.~   "
149605|NCT01608243|"~     The purpose of this study is to investigate the safety of different doses of sublingual~     tablets of house dust mite allergen extracts in adults with house dust mite-associated~     allergic asthma.~   "
149606|NCT01608230|"~     This study is being done to learn more about genetic mutations in cancer cells and to find~     out how the development of new technologies can increase knowledge of these mutations and~     possibly predict an individual's response to certain treatments.~   "
149607|NCT01608217|"~     This is a phase II, randomized, placebo-controlled, double-blind, parallel-group, multicentre~     study to the efficacy and safety of low dose delta-9-THC in behavioural disturbances and pain~     in patients with mild to severe dementia, when added to an analgesic treatment with~     acetaminophen.~      It is hypothesized that Namisol® will lead to more behavioural disturbances than placebo,~     when added to an analgesic treatment with acetaminophen, and as measured by a change in~     Neuropsychiatric Inventory (NPI) score, after a three week treatment period.~      It is expected that this will be due, primarily, to psychoactive effects of Namisol® and~     secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is~     expected that a reduction in NPS will positively affect quality of life and lead to better~     functioning in daily living.~   "
149608|NCT01608204|"~     The correlation between Busulfan Pharmacokinetics in AML transplanted patients and their GST~     (A1,T1,M1 and P1), MDR-1 genetic profile. If a pre-genetic testing of those genes can be~     utilized as biomarkers of SOS and/or HGVHD. This study is not an interventional study it is~     only checking the GST gene and MDR-1 gene~   "
149609|NCT01608191|"~     The aim of this study is to evaluate if an internet-based CBT (Cognitive Behavioral Therapy)~     programme for weight stability after LCD (Low Calorie diet) treatment for obesity, can reduce~     weight gain and improve weight stability, self reported health, pain, eating behavior,~     fatigue and mood.~      Adults with obesity and health problems in primary health care are invited to be part of the~     study. The geographical area is Orebro county which has in all 29 primary health care~     centers. Population is 276 000, and according to population studies around 15% of the adult~     population has a BodyMassIndex (BMI) over 30, which is characterized as obesity according to~     WHO.~      Specific objectives are;~        -  To evaluate if internet-based CBT treatment after LCD improves weight stability after 1~          and 2 years.~        -  To evaluate if weight loss improves metabolic parameters such as HbA1c, blood glucose,~          Cholesterol, Low density lipoproteins (LDL),High density lipoproteins (HDL) ,~          triglycerides (TG) and Bloodpressure (BP)~        -  To evaluate weight loss influence on quality of life, body pain, eating behavior,~          obesity related problems, fatigue and mood, and to see if CBT program for weight~          stability also improves these factors~        -  To evaluate if LCD treatment is a possible treatment for obesity in ordinary primary~          health care~      Patients taking part in the study, undergo a 12 week period of Low Calorie Diet (LCD)~     treatment, followed by a 12 week reintroduction to ordinary food. During this period the~     patient has contact with the primary health care nurse and doctor. After 24 weeks of~     treatment, the patient who follows the study is supposed to have lost around 10% of initial~     weight.All patients losing more than 7% weight during the first 24 weeks, are randomized to~     either ordinary follow up (group 1) or an internet-based CBT programme for weight stability~     (group 2). All patients in the study are followed at 1 year by doctor, and at 2 year by nurse~     visit.~   "
149636|NCT01607840|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities and alter functional connectivity in individuals~     with Schizophrenia. In this research, a 9 volt battery is used to deliver very weak~     electrical current to the surface of the scalp while participants complete cognitive tasks.~     Participants also receive a brain scan before and after stimulation. Our aim is to determine~     if tDCS can improve mental abilities in individuals with schizophrenia.~   "
149847|NCT01605071|"~     The aim of the current study is to test whether the effect of estrogen on insulin metabolism~     depends on the timing of treatment relative to when a woman went through menopause. The~     investigators hypothesize that estrogen will improve insulin sensitivity in early~     postmenopausal women, but decrease insulin sensitivity in late postmenopausal women.~   "
149610|NCT01608178|"~     Background:~      - Succinic semialdehyde dehydrogenase (SSADH) deficiency is a rare genetic disease that~     results in changes to certain brain chemicals. These chemicals may affect brain excitability,~     or how likely nerve cells are to turn on. Changes in brain excitability may help to explain~     the symptoms of the disease, including learning and memory problems, seizures, and poor~     balance. A supplement called taurine may help people with SSADH deficiency by working on the~     brain chemical GABA. GABA helps to regulate brain activity. Researchers want to see if~     taurine can help people with SSADH deficiency.~      Objectives:~      - To learn more about how taurine affects the brain in people with SSADH deficiency.~      Eligibility:~      - Individuals at least 12 years of age who have SSADH deficiency.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and urine samples. They will also take taurine supplements as part of this~          protocol.~        -  Participants will have two sets of study tests. One set will be given while participants~          are taking taurine. The second will be given when they are not taking it. Each testing~          session will take about 2 days to complete.~        -  Half of the participants will have the off taurine testing before starting on the~          taurine supplement. The other half will start taking taurine first, have the on~          taurine testing, and have the off taurine testing about 3 months after stopping~          taurine. Participants may decide the order in which they will have the testing done.~        -  Participants will have the following tests at the two test visits:~        -  Paper and pencil tests of learning and memory.~        -  Transcranial magnetic stimulation to study the excitability of nerve cells.~        -  Imaging studies to show GABA receptors in the brain and measure their activity.~        -  Electroencephalogram to measure brain waves.~        -  Lumbar puncture to collect spinal fluid.~        -  Participants will be monitored with regular study visits while they receive the taurine~          supplement treatment.~   "
149611|NCT01608165|"~     The number of people diagnosed with kidney cancer has doubled over the past 20 years, making~     it the eight most common cancer in the UK. Most tumours are less than 4cm in size, but over~     80% of these are malignant (cancerous) and if left untreated, will slowly grow and spread.~     Current standard treatment for these small kidney cancers is to remove the diseased part of~     the kidney in an operation called a partial nephrectomy, but this can be quite a difficult~     operation. Because of the small tumour size and difficulties with the operation, other~     treatments have been developed to destroy the tumours. These treatments include~     radiofrequency ablation, which means that the tumour is destroyed by heat, and cryoablation,~     which means that the tumour is frozen and destroyed.~      Although removing the part of the diseased kidney in an operation is the tried and tested way~     to treat the kidney cancer, it does have risks and complications, such as bleeding. The other~     two treatments are less intrusive to the patient, and are less complicated as they do not~     require such a large operation as having part of the kidney removed, but it is not known if~     they are as good at destroying all of the tumour, and whether or not patients who have their~     tumour destroyed with these new methods require further treatment in future.~      In this study, the investigators are trying to determine if a large-scale study comparing~     these treatments is possible which is why this is called a feasibility study. The~     investigators are also looking at whether patients would be willing to be randomly assigned~     to a treatment group. The results of this study will then be compared to see how effective~     each of the treatments were and whether the number of patients who were happy to be randomly~     assigned to a treatment could be used to determine the number of patients required in a~     large-scale trial.~   "
149612|NCT01608152|"~     Objectives:~      Aim 1. Develop a prototype intervention electronic game that implements a baseline testable~     feature set, including features for social networking within a virtual game space, managing~     an intermittent mediated reward cycle, goal setting and tracking, and collaborative problem~     solving.~      Aim 2. Evaluate the technical merit, feasibility, user perception and acceptance of the~     prototype system with adolescents and young adults (AYAs) allogeneic hematopoietic stem cell~     transplantation (HSCTs) patients in recovery.~   "
149613|NCT01608139|"~     The goal of this clinical research study is to learn the highest tolerable dose of the~     combination of curcumin, vorinostat, and sorafenib that can be given to patients with~     advanced solid cancer. The safety of this drug combination will also be studied.~   "
149614|NCT01608126|"~     The purpose of the study is to compare efficacy, complications and safety of the standard~     method of Combined (superficial and deep) cervical plexus block (SDCPB) with Ultrasound~     guided Medial Cervical plexus block technique (MCPB).~      Hypothesis: Ultrasound assisted MCPB is safer than SDCPB with similar efficacy.~   "
149615|NCT01608113|"~     Treatment naive patients with subfoveal nAMD initially treated monthly with intravitreal~     anti-VEGF and subsequently PRN, will be included in this study. Patients will be investigated~     for the first 2 years monthly and subsequently according to disease activity but at least~     every two months. Patients will be examined with 4m BCVA ETDRS distance visual acuity,~     reading acuity measured by Radner-Reading-Charts, contrast sensitivity by Pelli-Robson score,~     microperimetry and HD-OCT.~   "
149616|NCT01608100|"~     The objective of the study is to evaluate the performance and intended use of a new cardiac~     biomarker test, Troponin I, in an intended use population. Blood specimens will be tested~     using the new investigational test that detects the level of Troponin I. Results will be~     compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.~   "
149617|NCT01608087|"~     This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish~     pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.~   "
149618|NCT01608074|"~     Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral~     salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the~     investigators suggest, is to suppress the tubal source of possible dysplastic cells from~     which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.~   "
149619|NCT01608061|"~     The primary objective of this feasibility study is to evaluate the safety of DBS-f in~     patients with mild Alzheimer's disease by assessing all device and/or therapy related adverse~     events. The secondary objective is to preliminarily estimate the treatment effect size on the~     outcomes of interest at 12 months post-randomization. The objectives do not involve formal~     tests of hypotheses.~   "
149620|NCT01608048|"~     The objective of this study is to investigate the effect of transcutaneous electrical~     acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization.~   "
149621|NCT01608035|"~     The goal of this study is to determine if pre-operative placement of the continuous~     peripheral nerve block by an anesthesiologist using ultrasound technology is more effective~     than a continuous peripheral nerve block placed during the surgery by a surgeon for patients~     undergoing a limb amputation~   "
149637|NCT01607827|"~     The investigators aim to assess the procedure time and miss rate of polyps when performing~     polypectomy in the colon on the way up* and down** or only on the way down**.~      (* advancing the scope to the cecum, ** pulling back the scope after intubation of the~     cecum). Our hypothesis is that using the strategy to remove all visible polyps firstly on the~     way up and secondly on the way down is less time consuming and misses less polyps as with the~     strategy to remove polyps only on the way down.~   "
149757|NCT01606241|"~     This phase I clinical trial studies the side effects of vaccine therapy and cyclophosphamide~     in treating patients with stage II-III breast cancer or stage II-IV ovarian, primary~     peritoneal or fallopian tube cancer. Vaccines made from peptides may help the body build an~     effective immune response to kill tumor cells. Drugs used in chemotherapy, such as~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving vaccine~     therapy and cyclophosphamide may kill more tumor cells.~   "
149622|NCT01608022|"~     Esophageal cancer (EC) is the eighth most common cause of cancer-related death in the~     worldwide. Systemic chemotherapy in patients with metastatic EC has limited effectiveness,~     resulting in a median survival of 8 months to 10months. The low activity and brief duration~     of benefit for chemotherapy to palliate advanced disease make clear need to identify new~     active agents.~      Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to~     poor prognosis in patients with EC. The association between EGFR-activated signaling pathways~     and tumor cell survival are well documented in many studies. Some EGFR tyrosine kinase~     inhibitors (TKIs) already showed clinical efficacy against EC. A study with erlotinib showed~     objective response rate of 15% (2 of 13 patients), but activity was limited to squamous cell~     type.8 In another study, thirty patients with malignant solid tumor were treated with~     BIBW2992, irreversible inhibitor of EGFR and HER2, and one of four EC patients achieved~     partial response.~      PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. In~     preclinical studies, PF-00299804 has much lower IC50 values than gefitinib in cell lines~     engineered to express EGFRvIII mutations (1.2 nM versus 2,700 nM) and produces tumor growth~     inhibition in gefitinib-resistant xenografts. PF-00299804 reportedly have clinical anti-tumor~     activity in patients with non-small cell lung cancer and head and neck squamous cell~     carcinoma with manageable toxicity.~      The aim of current trial is to evaluate the antitumor efficacy and safety profile of~     PF-00299804 and to identify biomarker to predict the tumor response to PF-00299804.~   "
149623|NCT01608009|"~     The purpose of this study is to assess [18F] -fluciclatide as a biomarker of response to~     pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and~     paclitaxel in platinum-resistant ovarian cancer patients.~   "
149624|NCT01607996|"~     The aim of the study is to evaluate the safety, the potential beneficial effect of epidural~     anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute~     pancreatitis.~   "
149625|NCT01607983|"~     The study involves documenting the effects of inhaled nitric oxide upon ventricular-arterial~     coupling in patients with congenital heart disease and passive pulmonary blood flow.~     Consenting patients undergoing a clinically-indicated cardiac catheterization will be given~     inhaled nitric oxide for 10 minutes while intraventricular pressure-volume analysis will be~     make via conduction catheters.~   "
149626|NCT01607970|"~     The purpose of this study is to determine whether oxytocin affects the modulation of startle~     reactivity by aversive social stimuli and to investigate the oxytocin effect on moral~     judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR)~     polymorphisms on behavioral responses to social stimuli.~   "
149627|NCT01607957|"~     The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in~     patients with refractory metastatic colorectal cancer.~   "
149628|NCT01607944|"~     Incretin hormones (GLP-1 and GIP) have insulin secretory effects on the pancreas that are~     glucose dependent. Extrapancreatic effects of incretin hormones are reported, however the~     glucose dependency of these effects have not been examined. In type 2 diabetes, pancreatic~     endocrine function and incretin metabolism are impaired. The investigators hypothesize that~     extrapancreatic effects of incretin hormones are glucose depedent and dysregulated in~     subjects with type 2 diabetes.~      Healthy control subjects and type 2 diabetics will undergo pancreatic clamps. In brief,~     somatostatin will be infused to inhibit pancreatic endocrine function and basal levels of~     insulin, glucagon, and growth hormone will be replace via infusion. Metabolic flux will be~     studied during euglycemic and hyperglycemic stages of the pancreatic clamp. Each subject will~     undergo 3 trials involving the co-infusion of either saline(Control Trial), GLP-1, or GIP.~     Glucose metabolism will be assessed using 13C-glucose stable isotope methodology combined~     with indirect calorimetry and expired breath isotope ratio analysis. Blood flow and~     flow-mediated dilation will be measured using ultrasound Doppler. Skeletal muscle and~     abdominal adipose biopsies will be taken to examine intracellular signalling.~   "
149629|NCT01607931|"~     Human volunteers will be stratified by oral glucose tolerance status: normal glucose~     tolerant, impaired glucose tolerant, and type 2 diabetic. All subjects will undergo 4~     experimental trials: [1] an oral glucose tolerance test (OGTT) combined with infused and~     ingested stable isotopes of glucose to assess glucose kinetics. [2] a 1 hour bout of cycling~     exercise at 50% of maximum power output, immediately followed by the same OGTT combined with~     stable isotope glucose tracers used in trial 1. [3] an isoglycemic clamp to match the plasma~     glucose profile measured in trial 1. [4] a 1 hour bout of cycling exercise at 50% of maximum~     power output, immediately followed by an isoglycemic clamp to match the plasma glucose~     profile measured in trial 2.~      Exercise-induced changes in oral glucose tolerance, glucose kinetics, insulin and glucagon~     secretion, and the incretin effect will be examined. The exercise responses will be compared~     between the subjects groups of different glucose tolerance status.~   "
149630|NCT01607918|"~     The investigators aimed to compare the eradication rates of sequential therapy for 10 days~     versus triple therapy for 14 days~   "
149631|NCT01607905|"~     Phase 1 study to evaluate the safety and tolerability of KPT-330 and determine the~     Recommended Phase 2 Dose (RP2D) of KPT- 330 for advanced or metastatic solid tumor~     malignancies.~   "
149632|NCT01607892|"~     The purpose of this research study is to find out more information relating to the highest~     dose of KCP-330 that can be given safely and side effects it may cause, to examine how the~     body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the~     effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its~     effectiveness in treating cancer.~   "
149633|NCT01607879|"~     This is a study of HMB plus amino acids in older men with prostate cancer starting androgen~     deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional~     supplementation will decrease the loss of muscle mass and strength that occurs when men start~     ADT.~   "
149634|NCT01607866|"~     The most common benign tumor of the parotid gland is the so called pleomorphic adenoma.~     Although benign, this tumor may recur after surgical removal due to tumor cells left behind~     during the surgical operation. Thus, pleomorphic adenomas have been treated with wide~     resection similar to malignant tumors. This extensive surgery often leads to injury to the~     motor nerves responsible for facial expression and eye protection. The investigators propose~     less extensive surgery which should be thorough enough to prevent tumor recurrence while~     keeping the facial nerve out of risk.~   "
149638|NCT01607814|"~     Patients with cirrhosis can have abnormalities in laboratory tests reflecting changes in~     primary and secondary haemostasis.~      Such changes have been considered particularly relevant in the bleeding complications that~     occur in cirrhosis.~      However, several studies have shown that routine diagnostic tests are not clinically useful~     to stratify bleeding risk in patients with cirrhosis. Moreover, treatments used to increase~     platelet count or to modulate platelet function could potentially do harm. Consequently the~     optimal management of bleeding complications is still a matter of discussion.~      Moreover, in the last two decades there has been an increased recognition that not only~     bleeding but also thrombosis complicates the clinical course of cirrhosis. Over the last~     years, emerge that in vivo platelet function and coagulation cascade might be modulated by an~     alteration of pro-oxidant and antioxidant balance. Thus It has previously been demonstrated~     that chronic liver diseases are characterized by increased oxidative stress state.~      Aim of the study is to analyse the relationship between oxidative stress, haemostatic balance~     and clinical complications in cirrhosis.~   "
149639|NCT01607801|"~     background Operation for small umbilical hernias is one of the most common surgical~     procedures, but the best surgical technique, including the choice of suture or mesh remains~     unknown.~      It is well known that using non-absorbable sutures in closure of the abdomen, diminishes the~     risk of incisional hernias and wound healing problems.It has also been found that the use of~     resorbable suture in fixation of the mesh in Lichtesteins procedure leads to greater risk of~     recurrence of the hernia. Furthermore, it has been stated in smaller studies, that the use of~     the mesh in open operation for a small umbilical hernia has lower risk of recurrence (approx.~     1-3%) than sutured repair (10-12 %). However, the scientific literature is deficient, with~     few patients.~      The purpose of this study is to describe reoperation rate of recurrence after small umbilical~     hernias, depending on choice of sutures in both regular repair and in mesh repair.~      Hypothesis: sutured repair with non-absorbable suture has lower recurrence rates than with~     other types of sutures, whereas mesh repair has even lower recurrence rates in small~     umbilical hernia repairs.~   "
149640|NCT01607788|"~     The investigators propose a prospective, web-based database (developed within the framework~     of Quickbase, Intuit) which will allow an evaluation of the data for patients with a liver~     tumour who receive a liver transplant. Each site will continue to transplant according to~     their own criteria for inclusion on the waiting list. Each center will be responsible to~     enter a short list of data points at time of listing, transplant, and at 1 and 2 years post~     transplant. Data will be gathered prospectively through a web-based anaonymized database, and~     outcomes analyzed yearly X5 for tumour recurrence and patient survival.~   "
149641|NCT01607775|"~     Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate~     cage was designed and prospectively implanted in patients with a mono- or bilevel cervical~     pathology. As control, a commercially available PEEK-cage was used, patients were randomized~     using minimization randomization, controlling for age and bone mineral densitiy. The~     investigators hypothesize that the newly developed cage has similar clinical and radiological~     qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.~   "
149642|NCT01607762|"~     The purpose of this study is to compare capillary (the smallest of a body's blood vessels)~     and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single~     oral, immediate-release dose to healthy participants.~   "
149643|NCT01607749|"~     Undertake a study of educational intervention in primary schools in Andalusia~      HYPOTHESIS:~      There are differences in quality of life associated with asthma (as measured by the~     questionnaire PAQLQ) and the level of asthma control in students with asthma aged 11 and 12~     years who receive an educational intervention with their peers without asthma versus those~     receiving standard information in schools.~      OBJECTIVES: To compare the control of asthma symptoms, quality of life in asthma and asthma~     knowledge among a group receiving an educational intervention delivered by specialist~     teachers of physical education (MEEF) in Primary Schools (CEIP) and control.~      MÉTODOS group: Randomized controlled single-blind.~      POPULATION: Students of 11 and 12 years old in Andalusia~      Sample size: 258 children / children with asthma for a mean contrast (alpha error of 3.4%.~     80% power, a confidence level of 95% considering 20% loss. 2580 students will be enrolled~     prevalence of asthma 10%) . Conglomerates of the CEIP in urban, rural, public and~     private-reached.~      INTERVENTION: Training MEEF with the educational program Sports and Health Asthma and~     subsequent delivery, then the students MEEF are 5th and 6th grade ( 3 sessions). CONTROL: The~     standard instruction in schools. OUTCOME VARIABLES: Quality of life (Juniper) and control~     del asthma en niños(CAN) in asthmatics, Knowledge (NAKQ questionnaire) and attitudes toward~     asthma (all students and teachers). Pre-intervention (T0), post-intervention at 5-6 months~     (T1)~      Independent variables: Sex, suffering or not asthma, intervention / control, type CEIP.~      STATISTICAL ANALYSIS: Comparison of continuous variables: T Students (If normal distribution)~     Mann-Whitney (If non-normal distribution). To study qualitative variables chi-square test~     (normal distribution) and Kruskal-Wallis ( no-normal distribution).~   "
149644|NCT01607736|"~     Older individuals suffer from falls and fear of falling. The purpose of this study was to~     determine the effectiveness of a novel virtual gait training on walking performance and fear~     of falling in older adults, and to evaluate the feasibility of the virtual gait training~     program. The investigators hypothesize that virtual gait training in older adults over a~     three week period will both improve gait parameters as measured by a GAITRite® electronic~     walkway system, and reduce their fear of falling as measured by the Falls Efficacy~     Scale-International version.~   "
149645|NCT01607723|"~     Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +)~     are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the~     electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of~     this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies,~     and sleep pattern between NAVA and PAV+.~   "
149646|NCT01607710|"~     The investigators are seeking to locate the brain regions of interest in generalized anxiety~     disorder (GAD) using both structural (sMRI) and functional magnetic resonance imaging (fMRI).~     The MRI will be used to measure changes in blood flow in the brain while at rest and while~     completing tasks designed to elicit symptoms of anxiety. Results from a nonclinical control~     group and a GAD group will be compared to determine whether they exhibit different areas of~     brain activity during the tasks.~   "
149676|NCT01607294|"~     This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in~     subjects with type 2 diabetes.~   "
149758|NCT01606228|"~     The purpose of this study is to explore the tolerability, safety and efficacy of flexibly~     dosed paliperidone extended release (ER) among patients with schizophrenia.~   "
151287|NCT01586234|"~     The primary goal of this study is to determine if excimer laser smoothing of the cornea~     before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative~     Best Spectacle Corrected Visual Acuity (BSCVA).~   "
149647|NCT01607697|"~     Scientific Abstract:~      The investigators propose a study to examine the impact of a Mindfulness Based Intervention~     (MBI) on the quality of life and Non-Motor Symptoms (NMS) of persons with Parkinson's disease~     (PD).~      NMS add significantly to the disease burden and negatively impact the quality of life in PD~     (1,2). In a previous study the investigators confirmed the high prevalence of NMS in PD~     patients with either early- or late-onset of disease (3). Despite currently available~     treatments, PD leads to worsening disability and there remains a need for new approaches. A~     Mindfulness Based Intervention may provide an important adjuvant therapy in the treatment of~     PD in relation to NMS and quality of life.~      A minimum of 100 patients will be randomly assigned to the MBI or 'Treatment As Usual' (TAU)~     groups. Clinical assessments (motor and non-motor scores) will be performed in both groups.~     The TAU group will be offered MBI after completion of the study.~      To the best of our knowledge, this is the first large scale study using MBI in this~     indication.~   "
149648|NCT01607684|"~     The purpose of this study is to determine whether Magnetic Marker Monitoring is an~     appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects~     with diabetic polyneuropathy.~   "
149649|NCT01607671|"~     The purpose of this study is to evaluate the feasibility of rapid evaluation and~     administration of ophthalmic Timolol maleate in the treatment of non-arteritic anterior~     ischemic optic neuropathy. Secondary goals are to evaluate if such treatment reduces the~     progression or improves recovery of patients who are randomly assigned to treatment versus~     standard of care.~   "
149650|NCT01607658|"~     The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2~     intranasal testosterone gel to placebo on the occurrence of orgasm.~   "
149651|NCT01607645|"~     The goals of this study are to learn about the effectiveness, the side-effects, if waiting to~     give the idarubicin and cytarabine may change the side effects or effectiveness, and to~     identify factors to predict for responses to this therapy. The trial will examine combination~     of three chemotherapy drugs. These drugs are decitabine, idarubicin, and cytarabine.~   "
149652|NCT01607632|"~     A before and after study of veterans who took part in a 12-week loving-kindness meditation~     course as an adjunct to their usual care for posttraumatic stress disorder.~   "
149653|NCT01607619|"~     The investigators are studying a dietary supplement called anatabine in a lozenge form named~     RCP006. The main purpose of this study is to evaluate the effects of this dietary supplement~     on normal human inflammatory function. The investigators will see this effect in volunteers~     who have markers of higher levels of inflammation to begin with. The investigators anticipate~     that anatabine will reduce markers of inflammation. Therefore the investigators are looking~     for volunteers with high blood levels of C-reactive Protein (CRP) and will monitor the blood~     CRP levels at several time points throughout the study.~   "
149654|NCT01607593|"~     This is a multicenter retrospective study to investigate the dosage regimens of sertraline in~     the treatment of Posttraumatic Stress Disorder (PTSD) under current medical practice and the~     efficacy and safety of this drug in patients with PTSD. Data will be collected from the~     medical records of patients with PTSD.~   "
149655|NCT01607580|"~     Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only,~     option for the treatment of leukemia. However, GVHD rate was still high after haploidentical~     HSCT.~      It was found in our previous study that CD4/CD8>=1.16、CD56bright NK>1.9×106/kg in the graft~     was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).~      The study hypothesis:~      Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after~     unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of~     acute GVHD~   "
149656|NCT01607554|"~     Certain genetic factors can affect a patient's potential sensitivity to therapeutic drugs and~     other agents. There is a factor called ISG15 which might help doctors better identify~     patients with advanced non-small cell lung cancer (NSCLC) whose tumors may be more sensitive~     to the drug called Irinotecan. This factor is elevated in roughly 30% of NSCLC cases.~     Irinotecan is an agent that inhibits the enzyme called topoisomerase I that is involved in~     cell growth, and it has been FDA approved for 17 years for another type of cancer.~   "
149657|NCT01607541|"~     Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all~     adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment~     delays and disruptions are widespread. Heterosexuals at high risk (HHR) are significantly~     less likely to test for HIV, are more likely to be diagnosed with HIV late, and experience~     serious barriers to entering care compared to other groups. The investigators research team~     has studied HHR in New York City (NYC) as part of the CDC's National HIV Behavioral~     Surveillance (NHBS) studies. The investigators found an HIV prevalence rate of 7.4% among HHR~     in NYC, and only 6% of these infections had been previously diagnosed. Further, in central~     Brooklyn, 10% were newly diagnosed with HIV. The proposed study will use NHBS methodology to~     target HHR in central Brooklyn.~      The primary goal of the proposed study is to evaluate the efficacy of a peer-driven~     intervention (PDI) to seek, test, treat and retain HHR. The investigators will also compare~     the effectiveness of two sampling methods to reach HHR: Respondent-driven sampling (a~     peer-based approach) versus venue-based sampling (a location-based approach).~      The two main study hypotheses are:~      (H1): Participants recruited by respondent-driven sampling (RDS) will be more likely to test~     positive for HIV compared to those recruited via venue-based sampling (VBS).~      H2): Participants in the Test and Treat: phase of the peer-driven intervention (all of whom~     will be HIV-infected) will show a shorter time to an HIV clinical appointment, a shorter time~     to starting HIV medication (when medically indicated), higher rates of viral load~     suppression, and higher rates of retention in care compared to those in the control arm.~   "
149677|NCT01607281|"~     The study is designed to determine anaesthetists ability to locate the right internal jugular~     vein(IJV) and left IJV using a landmark technique. Initially, a questionnaire was completed~     detecting previous user experience. An ultrasound probe, using the midpoint as an 'imaginary~     needle', was placed on the neck of a healthy volunteer and the image recorded. Both~     anaesthetist and volunteer were blinded to the screen until the image was stored.~     Anaesthetists were grouped into senior or junior by the total number of IJV canulation~     experience. The success rate is going to be measured as pass or fail.~   "
149772|NCT01606046|"~     The purpose of this study is to compare the effects of vapocoolant spray and topical~     lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle~     electromyography.~   "
149658|NCT01607528|"~     Liver cirrhosis is the 10th most common cause of death in the western world. Infection is the~     most common precipitant of deterioration of liver function in cirrhosis. Endotoxin, derived~     from gram-negative organisms in the gut, can enter the circulation due to increased gut~     permeability and contributes to neutrophil dysfunction, infection risk and mortality in~     alcoholic cirrhotics. As probiotics decrease gram-negative organisms in the gut and/or~     decrease gut permeability, the investigators hypothesize that probiotic treatment would~     restore neutrophil function and prevent infection in alcoholic cirrhosis.~      The investigators hypothesize that administration of a probiotic mixture in patients with~     liver cirrhosis will improve innate immune function through alteration of the gut bacterial~     flora and gut barrier integrity.~      The aim of this randomised, double-blinded placebo-controlled study is to assess whether food~     supplementation with probiotic mixture improves neutrophil phagocytic capacity in patients~     with cirrhosis and decreases the incidence of significant infections.~      92 patients with alcoholic cirrhosis will be included according to a sample size calculation~     from preliminary data. Patients will be randomized in two groups: Group 1 receives a~     probiotic mixture Group 2 receives a similar looking and tasting placebo without bacteria.~     The recruited patients will be treated for 6 months. Besides routine clinical and laboratory~     assessments, neutrophil function, toll-like receptor expression, endotoxin levels, bacterial~     DNA, cytokine levels, albumin oxidation, gut permeability and analysis of gut microflora will~     be performed. Furthermore nutritional status and quality of life will be assessed.~      Primary endpoints will be neutrophil phagocytosis. Secondary endpoints will be significant~     infection, neutrophil oxidative burst, neutrophil toll-like receptor expression, endotoxin~     levels, bacterial DNA; cytokine levels, albumin oxidation, gut barrier function and bacterial~     flora, nutritional status and quality of life.~      If our hypothesis holds true, probiotics will provide an easily applicable and cost effective~     method to improve immune function and to prevent infection in liver cirrhosis. It is possible~     that this can improve survival of patients with liver cirrhosis.~   "
149659|NCT01607515|"~     Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25~     mmHg in the right heart catheterization.~      There are different forms of PH defined in the classification of Dana Point 2008.~      PH is diagnosed with right heart catheterization but there are other non invasive methods~     which can be used for screening like echocardiography, stress echocardiography and cardio~     pulmonary exercise testing.~      For prognosis of PH patients the limitation of the pulmonary circulation is very important.~     Therefore the cardiac index (CI) is a good parameter for the right ventricular function. The~     gold standard for CI measures is the thermodilution, an invasive method performed during~     right heart catheterization.~   "
149660|NCT01607502|"~     Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25~     mmHg measured in the right heart catheterization.~      There are different forms of PH defined in the classification of Dana Point 2008.~      PH is diagnosed with right heart catheterization but there are other non invasive methods~     which can be used for screening like the echocardiography, stress echocardiography and cardio~     pulmonary exercise testing. In the diagnosis process and in the follow up of PH patients~     biomarkers like NTproBNP are helpful. There are no specific biomarkers for the disease which~     can make the diagnosis process easier and predict prognosis.~      The systematic data collection in a data base provides better information about patients in~     daily routine and clinical studies as well as in the design of new studies.~   "
149661|NCT01607489|"~     The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of~     pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT). In~     this pilot study the investigators investigate patients who underwent right heart~     catheterisation with DE-CT to determine hemodynamic parameters and control the results by~     other clinical investigations. The investigators expect that using this non-invasive method,~     parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume,~     blood flow and perfusion heterogeneity, can be determined.~   "
149662|NCT01607476|"~     The intent of this research protocol is to test the equivalency of two amyloid imaging drugs~     (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there~     will be no significant difference in the distribution of the agents to areas of amyloid~     deposition in the brain or to other normal brain structures. Recent data have shown~     similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or mild~     cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has~     been published. It is important to understand differences in the images and biodistribution~     from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain~     structures such as white matter appear to differ slightly and could affect image performance.~   "
149663|NCT01607463|"~     The purpose of this study was to investigate whether transcutaneous electrical nerve~     stimulation (TENS) could reduce pain during cannulation of vein.~   "
149664|NCT01607450|"~     The objective of this proposal is to provide quantitative dose-response data for effects of~     GLP-1 on myocardial glucose uptake in healthy control subjects and obese type 2 diabetic~     subjects, in support of the design of later studies evaluating therapeutic applications of~     GLP-1 to heart disease.~      Aim 1: To measure the effects of GLP-1 infusion on myocardial fuel selection in lean healthy~     humans under fasting (fatty acid-dominant) conditions. Four groups of 10 lean healthy~     subjects will be studied during infusions of 0 (saline control), 0.5, 1.5, and 4.0~     pmol/kg/min GLP-1 (one study per subject). Cardiac metabolism will be measured using PET,~     using a dual-tracer approach which allows measurement of myocardial glucose uptake (the~     primary endpoint) along with total oxidation rate and myocardial perfusion (secondary~     endpoints). In concert with measures of circulating metabolites and regulatory hormones, the~     investigators will produce the most comprehensive assessment of actions of GLP-1 on~     myocardial metabolism in humans to date. Effects of each dose will be compared to the saline~     control, plus the investigators will combine all data and use nonlinear curve-fitting to~     derive sensitivity (ED50) and maximal responses for GLP-1 effects on myocardial glucose~     uptake.~      Aim 2: To measure the effects of GLP-1 infusion on myocardial fuel selection in obese type 2~     diabetic humans under fasting (fatty acid-dominant) conditions Four groups of 10 obese type 2~     diabetic subjects will be studied during infusions of 0, 0.5, 1.5, and 4.0 pmol/kg/min GLP-1~     as under Aim 1. Analyses will be parallel to those described under Aim 1. Results from Aims 1~     and 2 will be combined to allow direct comparison of the dose-response between nondiabetic~     control and type 2 diabetic subjects.~      No literature has been published to inform dose selection in the design of clinical trials of~     GLP-1 for modulation of heart fuel selection. With our expertise and experience in PET~     measurement of heart metabolism in diabetes, the investigators are uniquely positioned to~     fill this gap in knowledge. These studies are a necessary preamble to further evaluation of~     the potential for GLP-1 based treatments in heart disease.~   "
149665|NCT01607437|"~     No former studies have done long-term evaluation on patients reconstructed with hamstrings~     graft, the use of Howells tibial guide and transtibial drilling of the femoral graft tunnel.~     The investigators aim to evaluate clinical, radiographic and subjective outcome at a minimum~     of 10 years after surgery. According to former published studies on alike methods, the use of~     transtibial drilling of the femoral graft tunnel causes an increased rotational instability~     of the knee. The investigators aim to map the clinical stability of this group as well as~     evaluating the general outcome at the long-time horizon.~   "
149701|NCT01606969|"~     Scalp infiltration with Epinephrine- containing lidocaine solution is common method for~     craniotomy but it may result in transient but significant hypotension in patients undergoing~     neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently~     reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine~     response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus~     theologically appropriate for reducing bleeding during scalp incision in craniotomy.~      The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on~     hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.~   "
149666|NCT01607424|"~     Rationale:~      Cognitive deficits are a core feature in schizophrenia. Conventional treatments~     (antipsychotic medication and psychological treatments) have limited effects so cognitive~     remediation programs were designed to alleviate the problems. Interventions typically involve~     a variety of exercises in a paper and pencil or a computerized format with a growing number~     of specialized computer programs now being developed. However, many of these programs lack~     specificity which does not allow an individual's specific needs to be addressed. More~     targeted interventions might increase the effects of therapy so RECOS - COgnitive REmediation~     for Schizophrenia - was developed to fit this gap.~      Methods: This is a multicenter, randomized, controlled study comparing patients aged 18 to 45~     years suffering from schizophrenia according to DSM-IV-TR. RECOS will be compared to an~     already validated program (CRT).~      220 patients will be randomized as follows :~        -  Arm 1 : RECOS (42 h)~        -  Arm 2 : CRT (42 h) The recruitment is performed by psychiatrists in Lyon, Paris,~          Clermont-de-l'Oise, Niort, Bordeaux, Ville-Evrard and Lausanne.~   "
149667|NCT01607411|"~     An in situ model will be used to evaluate and compare enamel remineralization of human enamel~     specimens after single use of experimental children's toothpastes.~   "
149668|NCT01607398|"~     The study will be conducted in a respiratory specialist institute in Japan, with standardized~     techniques and data assurance checks to optimize data quality. The licensed dosage and~     administration of Adoair in Japan will be applied in this study. Each subject will receive~     treatment options in a randomized blinded fashion. Subjects will be randomized following a~     4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for~     12 weeks.~   "
149669|NCT01607385|"~     A single blind, randomized, placebo-controlled, dose escalating study to evaluate the safety,~     tolerability, pharmacokinetic and pharmacodynamic parameters of repeat doses of GSK2330672 in~     healthy volunteers, given alone and with a single day of dosing with GSK1614235~   "
149670|NCT01607372|"~     GSK2245035 is a highly selective Toll-like receptor 7 (TLR7) agonist that stimulates~     preferentially the induction of type I interferons. Intranasal (i.n.) administration of~     GSK2245035 in humans causes immune changes in the upper airways milieu that may alter~     bystander immune responsiveness to aeroallergens and contribute to reduction of allergic~     reactivity in subjects with respiratory allergies. The purpose of this study is to examine~     the safety and pharmacodynamics (PD) of repeat dosing with i.n. GSK2245035 in subjects with~     respiratory allergies. The safety and pharmacodynamic response of four weekly administrations~     of escalating doses of i.n. GSK2245035 will be investigated and the maximum tolerated dose~     will be established. The study will be conducted in patients with symptomatic allergic~     rhinitis and mild asthma. The overall duration of the study will be up to a maximum of~     approximately 122 days considering 90 days screening period, 22 days treatment period and 10~     days follow-up period.~   "
149671|NCT01607359|"~     Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter~     ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with~     warfarin are well established, the relative risk and benefit of dabigatran in this setting~     are unknown. The purposes of the study are to assess the efficacy of warfarin versus~     dabigatran in the prevention of stroke and other systemic embolic complications before and~     after catheter ablation for AF, and to compare the prevalence of serious bleeding~     complications with the two OAC agents.~   "
149672|NCT01607346|"~     This is a multicentre, open label study to examine the effect of ezogabine/retigabine on the~     voiding function of adult subjects with drug-resistant partial onset seizures (POS). Subjects~     fulfilling the study entry criteria at Screening and at Baseline including a comprehensive~     eye examination by an ophthalmologist or retina specialist and a skin assessment by the~     investigator will receive ezogabine/retigabine.~      The starting dose of ezogabine/retigabine will be 300 mg/day. Subjects will be up titrated by~     150 mg/day weekly up to the maximum ezogabine/retigabine daily dose of 1200 mg (or the~     highest tolerated dose). During the 49 days of the treatment phase, subjects will undergo~     three repeat non-invasive assessments of voiding function. In addition, subjects who meet~     pre-determined criteria for voiding dysfunction will undergo multichannel cystometry in order~     to characterise bladder hypocontractility, bladder outlet obstruction or a combination of~     events which clinically is manifest with difficulty emptying the bladder or acute urinary~     retention.~      At the end of the Treatment Phase, all subjects will enter the Taper Phase, a 3-week down~     titration period. Subjects who have new findings of abnormal pigmentation of the retina,~     unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin,~     lip, nail, or mucosa since baseline will be asked to enter the Safety Follow-Up /~     Continuation Phase. All subjects will undergo 6-monthly comprehensive eye examinations during~     the Safety Follow-Up / Continuation Phase. Subjects who have not developed abnormal~     discoloration of the skin, lips, nails or mucosa will continue to undergo skin assessments by~     the investigator. Any subject who has developed abnormal discoloration of the skin, lips,~     nails or mucosa since baseline will be referred to a dermatologist for evaluation and~     6-monthly follow up assessments. All subjects will continue to be followed until the~     pigmentation and/or discoloration has resolved or stabilised, as defined by no change over 2~     consecutive 6-monthly assessments conducted over at least 12 months after discontinuation of~     ezogabine/retigabine.~   "
149673|NCT01607333|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and~     disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on five key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation.~      In the present project, investigators use Columbia Classification Algorithm of suicide~     assessment (C-CASA) definitions as a basis to specify the operational definitions of the~     different aspects of suicidality. The focus of the main analyses is on attempted suicide~     including completed suicide. This is due to statistical power issues. However, investigators~     will apply two additional outcome definitions in sensitivity analyses: 1) completed suicide~     only and 2) completed suicide, suicide attempt, preparatory acts toward imminent suicidal~     behavior, suicidal ideation plus indeterminate or potentially suicidal events. Investigators~     will not include terms which clearly indicate an accidental event, or self-injurious behavior~     without a suicidal intent. These definitions are listed in the statistical analysis plan~     together with lists of terms from the dictionaries used in the different databases.~      The objectives of this study are to 1) Compare the study results which are based on two data~     sources (he UK General Practice Research Database (GPRD) and Danish registries) and different~     designs and evaluate the impact of design and population differences on the outcome of the~     study results (the UK database 'The Health Improvement Network' (THIN) may be included in~     these analyses as well); 2) Evaluate the strengths and weaknesses of the two data sources to~     study a possible association of antiepileptic drug (AED) use and suicidality, in particular~     the specific outcomes of death from suicide, hospitalization due to suicide attempt, and~     reports of the aspects of suicidality by the patients; 3) Estimate risks of completed~     suicide, completed suicide and attempted suicide, and completed suicide, suicide attempt,~     preparatory acts toward imminent suicidal behavior, suicidal ideation plus indeterminate or~     potentially suicidal events overall for all AEDs and by individual AEDs prescribed in UK and~     Denmark; and 4) Describe the patterns of AED prescribing in six European databases (GPRD and~     THIN, UK; Danish registries; Mondriaan, Netherlands; Bavaria, Germany; Base de Datos para la~     Investigación Farmacoepidemiologica en Atencion Primaria (BIFAP), Spain).~   "
149674|NCT01607320|"~     This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic~     ovarian syndrome (PCOS).~   "
149675|NCT01607307|"~     A multicenter randomized-controlled trial of daikenchuto (TJ-100), a traditional Japanese~     herbal medicine (Kampo), to investigate its effect on intestinal dysmotility and for the~     prevention of postoperative paralytic ileus.~   "
149678|NCT01607268|"~     This research study will be conducted in patients with primary autonomic failure, a disabling~     condition that is associated with low blood pressure upon standing. These patients are also~     not able to control for changes in their blood pressure due to a loss of cardiovascular~     reflexes that are mediated within the brain. The purpose of this study is to determine~     whether magnetic resonance spectroscopy (MRS), a non-invasive imaging technique, can measure~     levels of chemicals (neurotransmitters) in the dorsal medulla, a brain area important for~     control of cardiovascular function, in autonomic failure patients. Importantly, this study~     will determine whether there are differences in brain chemicals between patients with~     peripheral versus central origins of their autonomic failure. The hypothesis is that the~     neurotransmitter profile in the medulla will be intact in patients with peripheral autonomic~     failure compared to those with central impairment. Overall, this study will provide insight~     into understanding the mechanisms involved in autonomic failure and will determine whether a~     single session of MRS imaging can improve the ability to make an accurate diagnosis in these~     patients. This would lessen the need for more extensive and invasive clinical testing.~   "
149679|NCT01607255|"~     Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal~     cancer screening. Population studies have shown that traditional air colonoscopy fails to~     eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The~     investigators aim to establish the superior effectiveness of combining chromoendoscopy with~     the water exchange method in detecting more proximal diminutive adenomas during screening~     colonoscopy in sedated Veterans. An improved adenoma detection rate associated with optical~     colonoscopy will minimize the risk of missed lesions. The improvement may translate into a~     remedy for the limitations of screening colonoscopy in the proximal colon, e.g. a higher~     adenoma detection rate may minimize the burden of post screening colonoscopy interval~     colorectal cancers among the veteran population.~   "
149680|NCT01607242|"~     Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and~     swallowing function.~   "
149681|NCT01607229|"~     SPECIFIC AIM:~      Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium~     water (D2O) measurements.~      HYPOTHESIS:~      The Biospace Body Composition Analyzers are valid tools for measuring total body water and~     body composition.~   "
149682|NCT01607216|"~     This is an observational study that proposes to collect clinical, physiological, cellular and~     molecular information in an attempt to identify a set of factors that may predict the risk~     for persistent lung disease in babies born prematurely.~   "
149683|NCT01607203|"~     The purpose of this study is to see whether patients triggered with only human Chorion~     Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate~     than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.~   "
149684|NCT01607190|"~     The purpose of this study is to validate a predictive model of diabetic retinopathy~     progression in patients with diabetes mellitus type 2 patients to clinically significant~     macular edema (CSME) needing treatment either photocoagulation or intravitreal injections~     (ITV) using non-invasive techniques.~   "
149685|NCT01607177|"~     Preoperative exercise has been shown to improve physiological and functional capacity in~     patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients~     undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the~     setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is~     also thought to increase the likelihood that they will exercise postoperatively. However,~     compliance to this advice is extremely low. Text-message interventions have been shown to~     improve compliance to other lifestyle interventions. The investigators will compare the rate~     of compliance to preoperative exercise prior to bariatric surgery in patients who receive a~     daily text message to those who do not. The investigators will also compare weight loss.~   "
149686|NCT01607164|"~     This study is pilot testing a self-help automated Website (similar to a self-help book)~     designed to help individuals to learn methods to manage their mood. The methods are~     cognitive-behavioral skills found effective in the treatment of depression when provided by~     live therapists. The purpose of the study is to determine the number of individuals who will~     visit the site, use the site, and respond to online surveys reporting their mood levels while~     using the site, and at 1, 3, and 6 months after starting to use the site. The investigators~     want to eventually examine whether learning these methods online would help prevent~     depression.~   "
149687|NCT01607151|"~     Though TTM is ubiquitously used in the neuro-intensive care unit, there is limited experience~     with the use of TTM after intracerebral hemorrhage (ICH), the most devastating type of~     stroke. TTM may be a an intervention to improve patient outcomes. This trial addresses the~     safety and tolerability of a protocol of ultra-early TTM after ICH/IPH and may be the basis~     for future larger clinical trials.~   "
149688|NCT01607138|"~     Swallowing and speech difficulties will be observed in patients post laryngectomy. These~     difficulties will cause decreased in quality of life.~   "
149689|NCT01607125|"~     The purpose of this study is to determine if Vortioxetine 20 mg/day will lead to changes in~     neural activity (BOLD signal), as measured using fMRI, in brain areas associated with~     executive functioning and memory during cognitive task performances compared to placebo in~     subjects remitted from depression and in controls, and to explore if Vortioxetine will lead~     to improved cognitive performance in the absence of depression.~   "
149690|NCT01607112|"~     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'~     trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in~     adults (18 to 60 years) and in elderly (over 60 years).~   "
149702|NCT01606956|"~     Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion~     in adult patients. However, it is not proven how much the cuff should be inflated. The aim of~     this study is to compare efficacy between the method using the resting volume and the method~     using half the maximum volume for partial cuff inflation.~   "
149703|NCT01606943|"~     Clinical profiles and outcomes of patients with acute aortic dissection have not yet been~     evaluated in China. The aim of this study is to establish clinical registry of acute aortic~     dissection in China and to analyze clinical features, managements and outcomes of Chinese~     patients with acute aortic dissection.~   "
149691|NCT01607099|"~     For effective cleansing of the bowel prior to colonoscopy polyethylene glycol (e.g. macrogol)~     has widely been used in Germany. Usually patients have to drink between 4 an 6 liter of~     macrogol in a split dose (3 liter on the day before and 1 to 3 liter on the of the~     examination). One handicap of using polyethylene glycol is the occurence of nausea and~     vomiting which is due to the high amount of the laxativ and its bad taste. Therefore in a~     pilot study the investigators have detected a high fraction of patients who consider the~     cleansing procedure wich macrogol as very distressing. Thus patient acceptance of the~     colonoscopy procedure altogether is low.~      Since a few month sodium picosulfate/magnesium citrate is available for bowel cleansing in~     Germany. This preparation tastes better and needs less fluid intake. Usually 150 ml of sodium~     picosulfate/magnesium citrate are given twice within a 12 hour interval. Patients are~     instructed to drink plenty of water in addition to the laxative. In the mentioned pilot study~     the investigators found the cleansing procedure with picosulfate/magnesium citrate to be much~     more compatible compared to the macrogol regime. The effectiveness expressed by the cleanness~     of the bowel was equal in both groups.~      The investigators believe that a new protocol which contains sodium picosulfate/magnesium~     citrate instead of macrogol will benefit the patients by fewer abdominal side effects while~     cleanness of the bowel at the same time will be warranted. This presumption is the reason for~     the present study.~   "
149692|NCT01607086|"~     The objective of this sensory analysis study is to determine whether volunteers observe a~     significant difference in organoleptic properties between lamotrigine (430C78) cherry~     flavoured orally disintegrating tablets (ODT) and a placebo cherry flavoured orally~     disintegrating tablet. The aim is to assess the value of the placebo as a marketing aid,~     whereby physicians and patients may assess the personal acceptability of the organoleptic~     properties and potential convenience prior to prescription of the ODT formulation.~   "
149693|NCT01607073|"~     This study will assess how well the drug verapamil can improve control of seizures and~     dysautonomia symptoms in children and young adults diagnosed with Dravet syndrome. The safety~     of verapamil when given with all concomitant medications will also be assessed.~   "
149694|NCT01607060|"~     MAIN FEATURES OF THE STUDY: therapeutic intervention. Constipation is a frequent complication~     in critical ill patients. The disaccharide lactulose has a laxative osmotic activity. Given~     the scant evidence and the potential risk associated with constipation in seriously ill~     patients, this study aims to assess the impact of laxative therapy in the prognosis of~     critically ill patients.~      Study hypothesis: Constipation is part of the clinical spectrum of intestinal dysfunction and~     if treated can result in improved prognosis for critically ill patients.~   "
149695|NCT01607047|"~     Leptospirosis is a zoonosis of worldwide distribution whose incidence is higher in the~     tropics, where conditions for transmissions are favorable. The disease is endemic in~     Martinique and Guadeloupe, two Caribbean islands of the French West Indies. In tropical~     areas, many wild and domestic animals serve as reservoirs for pathogenic Leptospira strains~     and contaminate the environment by shedding the organisms in their urine. Humans are usually~     infected through abraded skin or mucous membrane contact with water contaminated by the urine~     of animal reservoirs, and less frequently by direct contact with animals or their urine. The~     mean incubation period is 10 days, with a usual range of 2-20 days. Clinical manifestations~     are protean and the spectrum of symptoms range from subclinical or mild anicteric febrile~     illness to acute renal failure and respiratory distress syndrome which are associated with~     high mortality rates.~      The microscopic agglutination test (MAT) and culture are the reference standard test for~     diagnosis of leptospirosis, but they are only available in reference laboratories and their~     conclusive results requires convalescent sample or prolonged incubation. At present, only~     direct detection methods using PCR might provide rapid diagnosis during the early acute stage~     of the illness, when treatment is likely to have the greatest benefit.~      Quantitative PCR also offers the ability to measure level of leptospiremia in clinical~     samples. Using qPCR based diagnosis, the investigators have the opportunity to study the~     association of level of leptospiremia and clinical manifestations in French West Indies. All~     qPCR-positive samples will be used for molecular typing.~   "
149696|NCT01607034|"~     To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in~     intact tablet form in the fasted and fed states in healthy volunteers.~   "
149697|NCT01607021|"~     The aim of this study is to investigate the relationships between interleukin 28B genetic~     variants and the response to treatment of chronic hepatitis C in Chinese children.~   "
149698|NCT01607008|"~     Prostate cancer is one of most common cancers in America, affecting 1 in 6 men. External beam~     radiation therapy is one of the common methods to treat prostate cancer. Although~     radiotherapy is effective, side effects to the adjacent normal organs limit the therapeutic~     ratio. Those side effects are usually associated with the radiation damage of the normal~     tissue surrounding prostate, e.g. bladder, urethra and rectum etc. Both effectiveness and the~     side effects of radiation treatment are often accessed after whole course of radiotherapy,~     which makes the early intervention difficult. The current research project is a feasibility~     study of utilizing advanced magnetic resonance imaging (MRI) techniques to access~     radiotherapy treatment response of prostate cancer during and right after radiotherapy.~      Many advanced MRI techniques, e.g. spectroscopy (MRS), diffusion-weighted (DWI), dynamic~     contrast enhanced (DCE) perfusion weighted images, have been used in radiology departments~     for diagnostic purpose. This research project is to study the feasibility of using advanced~     MRI sequences to monitor tissue response during and after radiotherapy. The tissue changes~     revealed from MRI can provide physicians early information on possible tumor recurrence and~     normal tissue toxicity, therefore, the early intervention may be possible to spare normal~     tissue and cure the patient. The project is designed to combine several different advanced~     MRI imaging techniques systematically to study tissue changes during radiotherapy, which has~     not been seen elsewhere to date.~      Another important goal of this research project is to study the feasibility of associating~     functional MRI with radiation treatment dose distribution. Tissue response during radiation~     treatment depends on dose. The functional MRI can provide more information than simple~     anatomic information. Mapping the functional MRI spatially and associating them with 3D dose~     distribution in radiation treatment planning system is one important step to quantitative~     assess the relationship between radiation treatment and tissue changes due to the radiation.~   "
149699|NCT01606995|"~     This is an international observational study in patients with non-valvular atrial~     fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent~     stroke or non-central nervous system systemic embolism.~   "
149700|NCT01606982|"~     The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor~     its safety in patients with metastatic castration-resistant prostate cancer previously~     treated with docetaxel-based chemotherapy.~   "
149773|NCT01606033|"~     This study aims to assess anxiety/depression and life quality of patients included in~     clinical trials versus patients treated in a standard way.~   "
151288|NCT01586221|"~     The purpose of this study is to see if group Music Therapy and Physical Therapy will help in~     the recovery from stroke. It is hoped that music and physical therapy in a group setting will~     help physical, mental, and social well-being.~   "
149704|NCT01606930|"~     The purpose of this controlled pilot study is to determine whether an intervention aimed at~     patients will improve partnering, shared decision-making and open communication. Results from~     this pilot study will inform how to best proceed with a larger multi-centered randomized~     controlled trial.~      The specific hypothesis for this pilot study is to:~        1. Test the feasibility of a simple patient-centered intervention.~        2. Test the correlation between patient readiness to actively engage in conversation~          (assessed using a pre-visit patient survey) and actual patient behaviors in the~          encounter.~        3. Develop a coding tool that will quantify patient activation in clinical encounters.~        4. Test whether activating patients who are more involved and revealing in the~          patient-clinician dyad will improve patient and clinician outcomes.~   "
149705|NCT01606917|"~     The purpose of this study is to examine the effects of a weight reduction program in adults,~     seen in a primary care setting, with overweight/obesity perceived as a health problem or with~     diseases related to overweight/obesity and ambitions to achieve weight reduction as part of~     treatment.~   "
149706|NCT01606904|"~     The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight~     loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart~     diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects~     suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and~     follow how they benefit from the program in order to achieve maintained weight loss. Also,~     the associations between weight loss, physical activity and musculoskeletal disorders are~     studied.~   "
149707|NCT01606891|"~     The goal of the Minnesota center is to integrate primary care, home, and community-based~     intervention strategies to promote sustained patterns of change in food intake, physical~     activity, and body weight among low income, ethnically diverse children. A culturally matched~     family connector will create linkages among the settings to support parents in making home~     environment and parenting behavior changes conducive to healthy growth and development in~     their children.~      Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted~     randomized controlled intervention on the primary outcome, child BMI, compared to a standard~     primary care-only intervention among 500 low income ethnic minority two to four year old~     children who are at or above the 50th percentile of BMI for age and gender.~      Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower~     BMI at 24 and 36 months, compared with children in the standard primary care only control~     group.~      Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted~     intervention on secondary outcomes, including change in child energy intake and physical~     activity energy expenditure, compared to a standard primary care-only intervention.~      Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower~     energy intake and higher energy expenditure over the three-year period, compared with~     children in the standard primary care-only control group.~      Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on~     hypothesized mediators of change in dietary intake, physical activity, and BMI.~      Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and~     physical activity environment will mediate changes in child energy intake and expenditure,~     and body mass index.~   "
149708|NCT01606878|"~     This phase I trial studies the side effects and the best dose of crizotinib giving together~     with combination chemotherapy in treating younger patients with relapsed or refractory solid~     tumors or anaplastic large cell lymphoma. Crizotinib may stop the growth of tumor or cancer~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as cyclophosphamide, topotecan hydrochloride, dexrazoxane hydrochloride, doxorubicin~     hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing~   "
149709|NCT01606865|"~     The aim of the study is to evaluate if there is an association between platelet inhibition~     and surgery-related bleeding in patients undergoing non-cardiac surgery during dual~     antiplatelet therapy.~   "
149710|NCT01606852|"~     Mechanical ventilation (MV) is the most frequently used life-support modality in intensive~     care units (ICUs). To reduce anxiety, stress and promote tolerance of MV, nurses frequently~     administer a variety of sedative medications to their patients based on subjective~     observations.~      The investigators hypothesize that patient-controlled sedation, compared to~     clinician-directed sedation, will decrease sedative exposure while decreasing patient anxiety~     during the episode of mechanical ventilation.~   "
149711|NCT01606839|"~     The study hypothesis is that accuracy of CO measurement by IGR does not differ from classical~     CO measurement methods such as thermodilution or direct Fick method. This is why the study~     aims to determine whether non invasive cardiac output (CO) measurement using inert gas~     rebreathing (IGR)is a suitable method in patients with pulmonary hypertension. In order to~     examine this, the IGR method will be used in patients undergoing diagnostic or follow-up~     right heart catheterization.~   "
149712|NCT01606826|"~     The mission of the SARP is to improve the understanding of severe asthma through integrated~     study of its clinical and biological features and to evaluate their changes over time. The~     ultimate goal of these efforts is to promote better treatments for severe asthma.~   "
149713|NCT01606813|"~     The investigators will conduct a randomized controlled trial comparing the effects of three~     interventions on weight loss at 12 months. The investigators propose to test the impact of~     integrating an effective automated Internet weight control program into primary care by~     recruiting patients and randomizing them to one of three conditions: A) Brief physician~     counseling plus usual care, B) Brief physician counseling plus referral and access to the~     Internet weight control program and, C) Brief physician counseling plus referral and access~     to the Internet weight control program plus brief follow-up email notes of support and~     accountability from Primary Care Physicians. The investigators hypothesize that an online~     program for weight control can be more effective by enhancing online follow-up with PCPs.~   "
149714|NCT01606800|"~     The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks)~     versus standard 48 week treatment in previously untreated adult participants with chronic~     hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as~     HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.~   "
149734|NCT01606540|"~     It is believed that some painkillers (NSAID drugs) slow bone healing but the knowledge is~     based only on experimental studies with animals whose results are automatically translated~     for humans. The purpose is to examine whether these drugs slow bone healing and what~     relationship there is between different bone examinations, scan for osteoporosis, bone marker~     laboratory tests, radiological controls and histology of newly formed bone under a~     microscope.~   "
149774|NCT01606020|"~     The effects of sleep deprivation (SD) on performance, while contradictory at first glance,~     are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal~     versus prolonged exercises. This latter type of exercise leads to the most important~     performance decrements after SD.~   "
151289|NCT01586208|"~     Identify the most effective dose of valproic acid when used in combination with phenytoin for~     treatment of patients with refractory status epilepticus, which allow a better clinical~     course and prognosis of the disease.~   "
149715|NCT01606787|"~     The purpose of this study is to determine if a medication called mannitol, can help the~     kidney maintain its function after kidney surgery. Mannitol is used to cause an increase in~     urine production (it is a diuretic). For many years, mannitol has been given to patients in~     the hope it would improve the kidney's circulation, and in doing so reduce the impact of the~     surgery on the kidney.~      Mannitol is given during the surgery before the blood supply to the kidney is stopped. The~     blood supply to the kidney is stopped in order to minimize any blood loss during the removal~     of the tumor, and also to assist the surgeons view of the kidney anatomy. Once the tumor is~     removed the blood supply to the kidney is resumed. Sometimes a side effect of this temporary~     reduction in blood supply to the kidney is the loss of some kidney function. This may happen~     either in the short term (right away) or long term (months or years later). In studies done~     on animals, mannitol was able to lessen this damage to kidney function. However, no human~     study has ever confirmed that mannitol has the same helpful effect in humans. There is some~     suggestion that it may have no effect. Because sufficient research has yet to be done on~     humans, many surgeons do not give mannitol. A recent study, conducted at Memorial Sloan~     Kettering which looked back at patients who had undergone partial nephrectomies, an operation~     where only the portion of the kidney that contains the tumor is removed and enables the~     normal, unaffected portion of the kidney to be preserved. The results of this study~     demonstrated no significant difference in kidney function when the investigators compared~     patients who were given mannitol to those who were not. The investigators hope that this~     study will help clarify the effectiveness or not of mannitol on kidney function. During the~     surgery to remove the kidney tumor, patients will receive either mannitol or a placebo. A~     placebo, is a harmless medication that has no effects. The impact of mannitol compared to the~     placebo will be assessed by routine blood tests and imaging (kidney scan) 6 months after your~     surgery.~   "
149716|NCT01606774|"~     The investigators plan to identify 80 pregnant women at low risk for obstetrical~     complications and replace 4-5 routine third trimester visits with a structured program of~     home weight, blood pressure and urine protein monitoring along with regular structured phone~     interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is~     both safe and acceptable.~   "
149717|NCT01606761|"~     The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction~     of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are~     unresponsive or intolerant to treatment with anti-TNF-alpha agents.~   "
149718|NCT01606748|"~     The purpose of this study is to investigate the pharmacokinetics (PK) of necitumumab in~     combination with gemcitabine-cisplatin in participants with advanced malignant solid tumors~     and to assess the potential for drug-drug interactions between necitumumab and~     gemcitabine-cisplatin.~   "
149719|NCT01606735|"~     This study will test the efficacy and safety of IBI-10090 in the treatment of ocular~     inflammation after ocular surgery.~   "
149720|NCT01606722|"~     To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations~     and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.~   "
149721|NCT01606709|"~     The purpose of this study is to compare gene expression profiles in endometrial biopsies~     during the window of implantation after triggers of oocyte maturation using GnRH agonist or~     hCG and compared with their natural cycles in order to identify genes that may be~     dysregulated in GnRH agonist-triggered cycles.~      The investigators also intend to evaluate patients feeling of well being and physical quality~     of life after GnRH agonist trigger compared with hCG trigger~   "
149722|NCT01606696|"~     The purpose of this study is to compare the effect higher intensity interval exercise (HIIT)~     with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients~     with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation.~   "
149723|NCT01606683|"~     The purpose of this study is the evaluation with untargeted modalities, of the urine~     metabolomic profile in a group of infants fed with a standard formula, a group of infants fed~     with a formula supplemented with functional ingredients and a group of breast-fed infants.~   "
149724|NCT01606670|"~     The primary objective of this study is to evaluate the perception of pain associated with~     Parkinson´s Disease in patients who receive Neupro® for the first time.~   "
149725|NCT01606657|"~     In this study, the investigators are trying to find out if washing out the abscess (pocket of~     pus) with fluid will help, instead of only taking out the pus. Your care will be the same as~     usual, except that you will be selected randomly to have your abscess washed out with fluid,~     or not.~   "
149726|NCT01606644|"~     Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue~     injury to salivary gland tissue.~   "
149727|NCT01606631|"~     The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of~     infectious diseases. They are one of the top ten causes of death in industrialized countries.~     But an eventual protective role of beta-blockers (anti-hypertensive drug) in their occurrence~     on a community infection has never been studied. The objective of this study is to evaluate~     this role.~   "
149728|NCT01606618|"~     With improved life expectancy over the last fifty years, spina bifida has become a disease of~     the adult. One of the major stakes for these patients is the preservation of a regular~     follow-up of uro-nephrologicals risk factors and of a respect for the rules of self~     management of their neurological bladder.~      The main objective of this study is to highlight a difference in the level of global~     self-esteem among a population of adult patients with spina bifida and a population of adult~     patients with traumatic spinal cord injury gained the same level of neurological.~   "
149729|NCT01606605|"~     The investigators perform a retrospective microarray gene expression profiling study of FFPE~     from a cohort of DLBCL patients with whole genome cDNA mediated Annealing Selection and~     Ligation (WG-DASL) assay. The investigators also study the pattern of microRNA from patients~     with diffuse large B-cell lymphoma. The results of gene expression profiles and microRNA is~     correlated with clinical outcomes of diffuse large B-cell lymphoma.~   "
149730|NCT01606592|"~     The efficacy of two forms of psychotherapy with panic disordered patients, a~     cognitive-behavioral and a psychodynamic one, are compared under two different, randomized~     conditions: randomization or self-selection. The basic hypotheses are that the efficacy of~     both treatments is higher and that the efficacy difference is smaller under self-selection~     than randomized conditions.~   "
149731|NCT01606579|"~     PRI-724 is a new investigational drug being studied to treat subjects with cancer who have~     advanced myeloid malignancies. PRI-724 is thought to work by blocking the Wnt signaling~     pathway that cancer cells need to grow and spread (metastasize).~   "
149732|NCT01606566|"~     The purpose of this study is to evaluate the efficacy and safety of PC-A11 with superficial~     and/or interstitial laser light application in patients with recurrent SCCHN.~   "
149733|NCT01606553|"~     The purpose of this study is to determine whether a high intensity short duration inspiratory~     muscle training is feasible, secure and effective to improve respiratory muscle function~     (strength and resistance), health-related quality of life, and to assess potential~     correlations with health resources utilization.~   "
149735|NCT01606527|"~     The proposed study is a prospective, randomized, double-blind, placebo-controlled clinical~     trial evaluating ibuprofen and placebo for the prevention of neurological forms of altitude~     illness [including high altitude headache (HAH), acute mountain sickness (AMS), high altitude~     cerebral edema (HACE), and an emerging concept of High Altitude Anxiety]. The study will take~     place in the spring and summer of 2012 at the Marine Corps Mountain Warfare Training Center~     in the Eastern Sierras near Bridgeport, California. US Marines from near sea level will~     participate in battalion-level training exercises at between 8,500-11,500 Feet, where some~     altitude illness is expected. Concurrent measures used to determine objective markers of~     altitude illness, such that validated clinical scales, rapid cognitive screening tests, will~     inform us of symptoms of altitude illness.~   "
149736|NCT01606514|"~     A single disaster, terrorist attack, or other large-scale incident can adversely affect~     thousands of youth and families. Immediate consequences may include unmet basic needs and~     high economic burden, particularly among underserved populations. Disasters also can~     dramatically affect family roles and relationships over time (e.g., family routines, marital~     stress, parent-child interactions). Whereas most youth are resilient in the aftermath of~     disasters (i.e., do not develop serious mental health or health-risk problems), the~     prevalence of various problems of public health significance (e.g., PTSD, depression,~     substance abuse) clearly increases in this population. This underscores the need for~     effective, widely accessible, culturally-appropriate and cost-efficient interventions that~     foster resilience or rapid recovery relative to the health effects of disasters. Yet, few~     evidence-informed resources are available to youth and families to facilitate post-disaster~     resilience and recovery. Primary aims of this project are: (a) to develop a Web-based~     intervention for disaster-affected adolescents and parents targeting prevalent health-related~     correlates of disasters (i.e., development phase), (b) to conduct a randomized controlled~     population-based study to examine feasibility and preliminary efficacy of the intervention~     (i.e., randomized controlled trial [RCT] phase) and cultural relevance (i.e., perceived~     applicability of the intervention to one's cultural group), and (c) to refine the~     intervention based on RCT-phase data.~   "
149737|NCT01606501|"~     The primary aim this prospective longitudinal observational outcomes study is to compare 18~     month functional outcomes and health related quality of life (HRQoL) of patients undergoing~     salvage versus amputation following severe distal tibia, ankle and/or foot fractures with~     major soft tissue, bone and/or ankle articular surface loss. Functional outcomes and HRQoL~     will be measured using well established self reported measures, including the Veterans Rand~     Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).~      Hypothesis 1: As a group, salvage patients with severe distal tibia, ankle and/or foot~     injuries with major soft tissue, bone and/or ankle articular surface loss will have similar~     functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of~     injury).~      Hypothesis 2: The subgroup of salvage patients who have either (1) a soft tissue injury that~     requires tissue transfer; (2) articular damage requiring arthrodesis of the ankle joint; or~     (3) bone loss at the distal tibia or ankle will have better functional outcomes and HRQoL had~     they undergone a transtibial amputation (within 6 weeks of injury).~   "
149738|NCT01606488|"~     Postoperative cognitive decline (POCD) affects up to 50% of non-cardiac surgical patients~     greater than or equal to 65 years of age.~      This study will test the hypothesis that preoperative presence of brain beta-amyloid plaques~     in non-demented subjects increases postoperative cognitive decline (POCD) in elderly subjects~     scheduled for hip or knee replacement.~      The investigators hypothesize that preoperative beta-amyloid plaques will predict~     postoperative cognitive decline.~   "
149739|NCT01606475|"~     The purpose of this study is to evaluate the safety and efficacy of islet transplants from~     human cadaver donors into type 1 or surgical diabetes mellitus patients who experience~     frequent acute or advanced chronic complications but do not qualify for other islet~     transplant trials. Under this protocol, patients may receive intraportal alloislet transplant~     under one of the following scenarios:~        1. islet transplant alone~        2. simultaneous islet-kidney transplant, or 3)islet after kidney transplant.~   "
149740|NCT01606462|"~     The purpose of this study is to determine whether oxytocin influences memory of social~     stimuli and reaction to social stimuli. Furthermore the investigators explore the effect of~     oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social~     stimuli.~   "
149741|NCT01606449|"~     Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can~     achieve outcomes that afford the patient lifelong satisfaction. The published results~     obtained with this surgery may not be considered to be definitive in relation to the length~     of follow-up or patients' life expectancy. The real recurrence rates and the results of~     surgery for GERD are difficult to assess due to the lack of serial time points during the~     follow-up. Further bias may have been introduced into the analysis by a lack of appropriate~     controls. The results of surgical therapy for type II-IV HH are even more controversial~     because of the high rate of anatomical relapse and the different methods of follow-up adopted~     in reported case series.~      Aim of this study is to clarify the value of surgical therapy for type II-IV HH. The~     investigators report on patients who were followed up after surgery at various time points~     over the course of 30 years.~   "
149742|NCT01606436|"~     This study will determine if a single dose of pomaglumetad methionil affects the electrical~     activity in the heart in people with schizophrenia. This study will also help determine how a~     single high dose of pomaglumetad methionil is tolerated by participants.~   "
149743|NCT01606423|"~     This is a study to measure the effect that various doses of LY2409021 have on blood sugar~     levels and on the amount of glucose released by the liver, when glucagon is given to increase~     these. Each participant may receive up to 2 single doses of LY2409021 in 2 different study~     periods, with a minimum 13-day washout between dosing periods. This study is approximately 9~     weeks long, not including screening. A screening appointment is required within 6 weeks prior~     to the start of the study.~   "
149775|NCT01606007|"~     The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS~     -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin~     (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of~     this treatment will also be studied.~   "
169950|NCT01341054|"~     To determine the Chamomilla recutita solution dose needed to reduce the intensity and~     evolution time of oral mucositis in adult subjects submitted to HSCT.~   "
149744|NCT01606410|"~     Rationale: Ischaemic preconditioning (IP) refers to the reduction of ischemia-reperfusion~     injury induced by a brief preceding period of ischemia. Also the arterial endothelium can be~     protected by IP. Several studies performed in animals and humans have demonstrated that the~     protective effects of IP are attenuated with aging. However, no previous study directly~     examined the underlying mechanisms of this observation. Possibly, the reduced protective~     effect of IP with aging relates to a direct effect on the endothelium, consequently leading~     to an attenuated ability of IP to prevent endothelial dysfunction after ischaemia reperfusion~     injury.~      Several previous studies failed to demonstrate the ability of pharmacological stimuli to~     mimic the beneficial effects of IP in aged vessels. Restoration of the age-related reduction~     in effectiveness of IP may be possible through exercise training. In aged animals, physical~     training restores the efficacy of ischemic preconditioning. Indirect evidence indicates that~     physical activity, independent of other cardiovascular risk factors, protects against a~     occurrence as well as the severity of a myocardial infarction in humans. Although this~     suggests that physical activity may beneficially influence the age-related reduction in IP,~     no previous study provided direct evidence for this hypothesis.~      Objective: To examine the impact of age and physical fitness on the ability of ischaemic~     preconditioning to protect endothelial damage in response to ischaemia reperfusion injury in~     healthy humans. A secondary objective is to explore the role of Toll-like receptor (TLR)~     signalling in the induction of IP in young and old subjects.~   "
149745|NCT01606397|"~     The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary~     purpose of this study is to help answer the following research questions, and not to provide~     treatment for diabetes :~        -  The safety of LY2409021 and any side effects that might be associated with it following~          4 weeks of doses~        -  How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks~        -  How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other~          naturally occurring substances before and after a meal~        -  How LY2409021 works when given with metformin~        -  How daily dosing of LY2409021 affects the cells that produce insulin~   "
149746|NCT01606384|"~     Primary Objective:~      - To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on~     hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.~      Secondary Objectives:~        -  To evaluate the tolerability and safety of SSR149415 in patients with major depressive~          disorder.~        -  To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients~          with major depressive disorder.~        -  To evaluate plasma concentrations of SSR149415.~   "
149747|NCT01606371|"~     The main purpose of this study is to determine the safety of LY2409021 in healthy~     participants and participants with diabetes. The study drug is given as single oral doses.~     Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing~     periods. Side effects will be documented. This study is approximately 9 weeks long, not~     including screening. Screening is required within 6 weeks prior to the start of the study.~   "
149748|NCT01606358|"~     In patients with an ovarian cancer, the treatment is currently based on surgery and~     chemotherapy.~      The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T~     cells has never been evaluated.~      The long term goal is to give a rational to combine conventional treatment of ovarian cancer~     with immunotherapy based on Vgamma9Vdelta2 T cells.~   "
149749|NCT01606345|"~     The purpose of this study is to learn more about how well the drug valrubicin (VALSTAR®)~     works to help treat the patient's cancer when administered through a nephrostomy tube~     inserted through their back into their kidney. The study is also being done to determine how~     safe and easy it is to tolerate valrubicin at specific dose levels, as well as the way in~     which the drug is eliminated from the human body (Pharmacokinetics or PK).~   "
149750|NCT01606332|"~     In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a~     postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing~     shoulder pain and improving range of motion compared to a single-dose interscalene block.~   "
149751|NCT01606319|"~     The Acetaminophen Versus Ibuprofen in Children with Asthma study will test the primary~     hypothesis that in preschool children 12-59 months of age with persistent asthma on~     standardized asthma therapy, the number of asthma exacerbations requiring systemic~     corticosteroids will be more frequent in children randomized to receive acetaminophen as~     compared to those randomized to receive ibuprofen on an as needed basis for fevers and pain.~   "
149752|NCT01606306|"~     The INFANT study will test whether, in preschool children 12-59 months of age with persistent~     asthma, the following Step 2 asthma therapies will provide similar degrees of asthma control:~        1. Daily inhaled corticosteroid (ICS) treatment,~        2. Daily leukotriene receptor antagonist (LTRA) treatment, and~        3. As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.~   "
149753|NCT01606293|"~     Objectives:~      Primary: 1. To assess the feasibility of using social networking groups to survey patients~     with rare cancers.~      Secondary:1. To elucidate the current means for diagnosis and treatment of women with small~     and large cell carcinomas of the cervix. 2. To evaluate anxiety regarding diagnosis,~     treatment, and recurrence among women with small and large cell carcinomas of the cervix.~   "
149754|NCT01606280|"~     This study examines the value of stem cell transplantation in managing light chain~     amyloidisis.~   "
149755|NCT01606267|"~     The purpose of this study is to to measure the effect of the HEP+ICCM program relative to~     routine HEP approach in rural Ethiopia on changes in coverage of case management of common~     childhood illnesses and severe acute malnutrition, reductions in mortality among children~     under the age of five, and improvements in nutritional status using a rigorous evaluation~     design.~   "
149756|NCT01606254|"~     The purpose of this study is to assess the pharmacokinetics (the study of the way a drug~     enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in~     participants with schizophrenia (psychiatric disorder with symptoms of emotional instability,~     detachment from reality, often with delusions and hallucinations, and withdrawal into the~     self).~   "
149776|NCT01605994|"~     Includes a placebo-controlled sequential, ascending multiple-dose panels (10 panels, 8~     ascending doses, and 2 fixed Japanese Panels exploring safety, tolerability, and~     Pharmacokinetic (PK) measures~   "
149759|NCT01606215|"~     This is a randomised, double-blind crossover study to study the effect of intravenous~     treatment with autologous (derived from the individuals themselves) mesenchymal stem cells~     (MSCs)in patients with multiple sclerosis (MS).~      Current treatments for MS target the immune system and are not curative. There is much~     interest in MSCs as they have the potential to not only affect the immune system but may also~     promote repair. This study will use MSCs that are harvested from the bone marrow and grown~     for up to 52 days before being given back to the person from whom they were harvested. This~     avoids any chemotherapy so is therefore safer than other types of stem cells. In this~     crossover study, everyone will receive their own stem cells back but in half it will be~     delayed by 24 weeks.~      The primary outcomes are to check that the procedure is safe and to measure any changes on~     the MRI at 24 weeks. Other more exploratory measures will try to assess effects on repair in~     the central nervous system (CNS).~   "
149760|NCT01606202|"~     A study to investigate the effects of sublingual cannabis based medicine extracts on~     neuropathic pain associated with spinal cord injury.~   "
149761|NCT01606189|"~     A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with~     placebo in the treatment of chronic pain due to brachial plexus injury.~   "
149762|NCT01606176|"~     To investigate the ability of a cannabis based medicine extract to relieve chronic refractory~     pain of neurological origin.~   "
149763|NCT01606163|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male~     adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous~     injection.~   "
149764|NCT01606150|"~     The purpose of this study is to compare two medications used to numb an infant's back when~     performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain~     cerebrospinal fluid (CSF). This is achieved by inserting a small needle between the infant's~     vertebrae. In the past, doctors did not know if newborns could feel the pain from a procedure~     like this in the same way that adults do. Investigators now know that the newborns do~     experience pain during this procedure, but we do not know the best way to control this pain.~     Investigators also think that when the newborns have pain, they move during the test. The~     movement can increase the chance of having blood mix with this normally clear fluid leading~     to limitations in our clinical application of these results. This study will compare the~     injected and topical forms of Lidocaine to see which gives us better pain control and more~     clear results. The investigators hypothesize that subcutaneous 1% Lidocaine, due to its~     deeper penetration, will be 25% superior to topical liposomal Lidocaine (LMX-4) in both the~     rate of clinically useful results and pain scores. The investigators hypothesize that both~     forms of Lidocaine will be 25% superior to our historical control cohort in the rate of~     clinically useful results.~   "
149765|NCT01606137|"~     Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it~     in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.~   "
149766|NCT01606124|"~     This phase II trial studies how well Polyphenon E works in treating patients with high-risk~     of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal~     cancer.~   "
149767|NCT01606111|"~     The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on~     therapy to standard care in patients with acute traumatic brain injury (TBI). The study~     duration for each patient is 180 days.~   "
149768|NCT01606098|"~     The clinical benefit of resection of the primary tumour in patients with synchronous~     unresectable metastases is not known. In the literature studies usually describe~     retrospective selected patients with synchronous metastases treated with or without resection~     of the primary tumour. All these studies are biased in patient selection and there are no~     prospective randomized studies on this topic. In patients with few or absent symptoms of the~     primary tumour, arguments both in favour and against initial resection have been presented,~     and therefore a randomized trial is warranted. Although recent publications suggest that~     resection of the primary tumour in synchronous metastasized colon cancer patients might not~     be necessary, this appears to be based on feasibility and not on clinical outcome. Several~     studies comparing large groups of patients with or without resection of the primary tumour~     suggest an improved survival when the primary tumour is resected. A potential benefit of~     resection of the primary tumour is to prevent complications of the primary tumour during~     chemotherapy treatment or during later stages of the disease. A recent analysis of the CAIRO~     and CAIRO2 data showed that metastatic colon cancer patients who had a resection of the~     primary tumour prior to study entry, had an improved survival compared to patients without a~     resection of the primary tumour. However, these patients were selected after the primary~     tumour was resected and therefore these results are not corrected for surgical morbidity and~     mortality. The investigators here propose a randomized trial in order to demonstrate that~     resection of the primary tumour does improve overall survival.~   "
149769|NCT01606085|"~     The purposes of this study are:~        1. to develop and test an integrated self care intervention for Heart Failure (HF)patients~          with Diabetes (DM) for its effects on patient outcomes including health related quality~          of life (HRQOL), physical function and health resource utilization.~        2. to assess the costs and cost effectiveness of the intervention.~      The intervention is designed to go beyond usual care of providing separate Heart Failure (HF)~     and Diabetes (DM) patient education by educating HF-DM patients on integrated self care and~     self management related to a HF-DM diet, HF-DM medication-taking behaviors, physical~     activity, and HF-DM symptom monitoring and management. An integrated self care intervention~     will compare HF-DM patients who receive the intervention with those who receive usual~     care-attention control for effects on patient outcomes,self care process measures, and health~     care utilization. If effective, the intervention will lead to improved self care, improved~     quality of life, and reduced health care resource use and costs. This study will facilitate~     greater understanding of self care within the context of two chronic illnesses and will lead~     directly to improved clinical practice and future research on comorbid self care in Heart~     Failure.~   "
149770|NCT01606072|"~     The propose for this study is to evaluate the safety and tolerability of desmopressin when~     administered perioperatively to patients with breast cancer undergoing surgery as first~     treatment, and select the optimum dose for the clinical development of the product.~   "
149771|NCT01606059|"~     The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920~     in healthy male volunteers under fasting condition.~   "
149778|NCT01605968|"~     Study objective:~      The objective of this study is to evaluate through clinical criteria the clinical efficacy~     and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as~     effective and safe as Aquacel® Ag. Dressing.~      Study devices:~        -  Study device: BCT Silver Bandage~        -  Comparator device:ConvaTecAquacel® Ag Hydrofiber Dressing~      Study design:~        -  Randomized, Open-label, interventional, comparative, preventive study with Blinded~          evaluator.~        -  All subjects must meet all the inclusion & exclusion criteria to enter this study in~          pre-operative phase.~        -  Eligible subjects will be enrolled after a scheduled operative procedure.~        -  There is SEVEN visits in this study (one screening eligibility phase up to 7 days before~          OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th~          day, 12th day and two follow up visit on the 28th and the 42nd post-operative day.~        -  During each scheduled visit, each subject will have colored picture of his wound after~          dressing been removed, and on visit V6 for wound evaluation by blinded PI.~      Number of subjects: It is expected to recruit ≧150 eligible subjects.~      Study Duration: About eighteen month.~   "
149779|NCT01605955|"~     The purpose of this study is to validate the SpO2 accuracy of pulse oximeter equipment in~     comparison to gold-standard measurements of blood SaO2 by a CO-oximeter~   "
149780|NCT01605942|"~     This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior~     segment inflammation and pain following cataract extraction with lens implantation.~   "
149781|NCT01605929|"~     The primary objective of this prospective, descriptive study is to evaluate the success rate~     of the retroclavicular brachial plexus block and catheter placement in 60 adult patients~     undergoing hand, wrist, or forearm surgery. The investigators will also evaluate any~     difficulties performing the procedure, the onset time and distribution of the block,~     incidence of adverse events, and patient's acceptance of the block.~   "
149782|NCT01605916|"~     The objective of this study will be to investigate the safety and tolerability of AZD6244~     given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients~     with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung~     Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following~     the combination regimen dose escalation phase (Part A) of the study additional patients may~     be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability,~     pharmacokinetics and biological activity of the combination in this patient population.~   "
149783|NCT01605903|"~     Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in~     children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous~     in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal~     anti-inflammatory medication (NSAID), is an effective pain medication. Recent guidelines,~     published by the American Academy of Otolaryngology, advocated use of ibuprofen after~     tonsillectomy. However, NSAIDs are associated with altered platelet function and a~     theoretical increased risk of bleeding after surgery. The investigators would like to explore~     the effect that ibuprofen has on postoperative bleeding, as well as validate previous studies~     demonstrating it is an effective pain medication after tonsillectomy.~   "
149784|NCT01605890|"~     The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same~     sensibility to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are~     appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy~     including PI is less effective for HIV-2. Also, the choice of ARTs in a second line treatment~     is limited. The first line optimal treatment has to be defined by a prospective and~     randomized evaluation of other strategies. The primary endpoint will be adapted to the~     specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical~     trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to~     the classical triple therapy, shows an immunovirological response, at least, as good as the~     one obtained with the triple therapy. The hypothesis is that the low ART response observed in~     HIV-2 infection is due to a low virological strength of the ARTs used and that the~     combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at~     week 48.~   "
149785|NCT01605877|"~     The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +2.5~     D Multifocal IOL Model SN6AD2 [SV25T0] in Japanese cataract patients.~   "
149786|NCT01605864|"~     Community-acquired bacterial pneumonia, which is often called CAP, is a bacterial infection~     in the lungs and is treated with antibiotics. Sometimes people need to be in the hospital to~     be treated for CAP. Usually, hospitalized persons with CAP are given two antibiotics~     together. These antibiotics usually include a cephalosporin and a macrolide. The most~     commonly used cephalosporin at Albany Medical Center Hospital is ceftriaxone. The most~     commonly used macrolides at Albany Medical Center Hospital are azithromycin and doxycycline.~      This research is being done to find out how well a new cephalosporin antibiotic, called~     ceftaroline, works in combination with a macrolide for the treatment of CAP. Ceftaroline is~     similar to ceftriaxone. Ceftaroline was recently approved by the FDA to treat pneumonia in~     hospitalized patients based on two research studies. In one study, ceftaroline was better~     than ceftriaxone. In the second study, ceftaroline was just as good as ceftriaxone.~     Ceftaroline was very well tolerated in both clinical studies and it was found to be as safe~     as ceftriaxone.~   "
149787|NCT01605851|"~     The primary objective of this study is to evaluate clinical success and performance of the~     GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen~     Ovale (PFO).~   "
149810|NCT01605552|"~     The objective of this clinical trial is to evaluate whether a computerized depression~     treatment, delivered before the onset of heart disease, reduces the risk of heart disease in~     the future. Participants in this trial will be primary care patients who are depressed but do~     not have a history of heart disease. Half of these patients will receive a standard treatment~     (usual care), and the other half will receive eight weeks of an evidence-based psychological~     treatment called Beating the Blues®, which is a computerized, cognitive behavioral treatment~     program for depression. To evaluate change in heart disease risk, the investigators will~     measure the functioning of the arteries using ultrasound before and after the treatment. It~     is hypothesized that patients who receive Beating the Blues® will show greater improvements~     in both depression and artery function than patients who receive standard treatment.~   "
149788|NCT01605838|"~     BACKGROUND: The brain is very sensitive to both excessive and insufficient flow of blood.~     Cerebral blood flow (CBF) is normally auto-regulated by the blood vessels in the brain, but~     this protective mechanism is often disturbed after a traumatic brain injury (TBI). Impairment~     or loss of the CBF autoregulation makes the brain vulnerable to oscillations of either~     arterial blood pressure (ABP) or intracranial pressure (ICP). The ideal management of TBI~     patients, therefore, involves continuous measurement and management of the cerebral perfusion~     pressure (CPP = ABP - ICP) but the measurement of CPP is currently possible only with~     specialized equipment and expertise that is not available in all institutions. The~     investigators have converted a no-longer used system that continuously monitors CBF~     autoregulation using rheoencephalography (REG) technology into a modern, small,~     battery-powered, low-cost monitor (aka BM-1) that acquires the REG signals using only~     noninvasive electrodes placed on the skin/scalp. REG data can then be used to calculate the~     optimal CPP to maintain in each individual patient. BM-1 is also capable of monitoring~     electroencephalography (EEG) and impedance plethysmography (IPG), which can, respectively, be~     used to measure brain electrical activity and changes in peripheral blood flow caused by~     blood pressure changes.~      OBJECTIVES: The primary objectives are to (Obj. 1) demonstrate that REG acquired~     noninvasively is equal to the well-established but invasive method using intracranial~     pressure (ICP) monitoring, (Obj. 2) retrospectively test the idea that TBI patients have a~     less favorable outcome if their CPP were found less optimal using the REG data, and (Obj. 3)~     determine if noninvasive IPG or the PPG finger sensor monitoring (used to measure heart rate~     in doctor's offices) can replace the invasive monitoring of arterial blood pressure (ABP).~      METHODOLOGY: This is an observational study with retrospective data analysis. 20 adult~     patients (18-65 yrs) with acute TBI, who meet the inclusion/exclusion criteria, will be~     enrolled on a first-come-first-enroll basis. The enrolled patients will have the REG, EEG and~     IPG signals monitored for the duration of ICU stay or 15 days, whichever is shorter. Standard~     neurological assessment will be made at the patient's discharge from the ICU and at 3 months~     after injury. The study is expected to end June 2013.~   "
149789|NCT01605825|"~     This is a multi-center, safety and tolerability study in subjects with chronic stable~     sensorimotor deficits after ischemic stroke. It has been designed as a double-blind,~     placebo-controlled, 2-period crossover study.~   "
149790|NCT01605812|"~     In this study, the investigators examined the capsule-IOL interaction including anterior and~     posterior capsule adhesion, contact between posterior capsule and the posterior edge of~     intraocular lense (IOL), configuration of capsular bend and the incidence of posterior~     capsular opacity (PCO) between high myopia eyes and emmetropia eyes.~   "
149791|NCT01605799|"~     The goals of this project are~        -  1) to evaluate the effectiveness of a CBT treatment module addressing the mental health~          and functional impact of killing in the war zone,~        -  2) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility~          of the CBT treatment module, which would be used to further refine the intervention, and~        -  3) to gather data on clinician stakeholders' perceptions of acceptability and~          feasibility of the CBT treatment module, which would be used to ensure that the module~          could be easily integrated into EBT for PTSD.~   "
149792|NCT01605786|"~     This study intends to test the hypothesis that the malaria antigen PfPEBS, manufactured as a~     synthetic protein and adjuvanted with aluminium hydroxide will be well-tolerated and~     immunogenic (Phase 1), functionally active against the erythrocytic stages (Phase 1) and~     efficacious (Phase 2) against the pre-erythrocytic stages in protecting against an artificial~     malaria challenge using Pf sporozoites in a healthy adult population.~   "
149793|NCT01605773|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes.~   "
149794|NCT01605760|"~     The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in~     patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust~     mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis~     and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick~     tests, serum-specific IgE and nasal provocation tests were included. Patients were~     individually randomised to groups: active or placebo using a double-blind method. A total of~     51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R,~     Stallergens, France) and 57 in the placebo group were monitored for three years. The patients~     had to record on a diary card whenever they used anti-allergic medications.~   "
149795|NCT01605747|"~     The primary objective of this study is to determine if probiotic prophylaxis has immunologic~     and gastrointestinal advantages in pediatric burn patients.~   "
149796|NCT01605734|"~     TACE is widely used in patients with unresectable HCC. However, it is a non-curative~     approach; thus ,strategies to further improve the survival of these patients are needed.~     Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic~     therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that~     the combination of TACE with sorafenib could improve the survival of patients with~     unresectable HCC.~   "
149797|NCT01605721|"~     Objectives:~        1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE~          PRIMETM in a cohort of real world patients and lesion subsets.~        2. To determine clinical device and procedural success during commercial use of XIENCE~          PRIMETM coronary stent~      Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM~      Study period~        -  Patient enrollment: 2011.05 ~ 2012.04~        -  End of follow-up period: 2015. 02 (3 years of follow-up)~      Primary endpoint~      : Target Lesion Failure (TLF) rate at 12 months~      Secondary endpoint:~        -  In-stent & In-segment Late Loss at 9 months~        -  Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3~          years (very late)~        -  Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)~        -  Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years~        -  Composite rate of cardiac death and any MI up to 3 years~        -  Composite rate of all death and any MI up to 3 years~        -  Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat~          revascularization up to 3 years~        -  Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up~          to 3 years~        -  Procedural success up to 1 day~        -  Angiographic success up to 1 day~   "
149798|NCT01605708|"~     The purpose of this study is to assess the clinical activity on refractory moderate-to-severe~     pruritus of a single intravenous (IV) dose of REGN846 in adult patients with~     moderate-to-severe atopic dermatitis (AD).~   "
149799|NCT01605695|"~     The discovery that inducible nitric oxide synthase (iNOS) circulates in people who are~     developing the sepsis pathology has provided an opportunity to develop a first-in-class~     diagnostic test for the onset of sepsis. This study is designed to determine the normal human~     plasma level of circulating iNOS as the initial reference level against which hospitalized~     patients at risk for the development of sepsis can be compared to ascertain if the patient is~     at risk for becoming septic based upon an elevated level of plasma iNOS.~   "
149800|NCT01605682|"~     Berry fruits are widely recognised as natural functional food products. They contain several~     different phytochemicals which have potential to modulate human health and wellbeing. There~     is however some debate regarding the mechanisms driving their health promoting properties.~      Despite the wide health promoting properties of fruit extracts reported in the literature,~     considerable interest over the past decade has primarily been focused on their roles in~     reducing risk factors associated with cancer and heart disease. Consequently, there remains a~     paucity of actual scientific information on their role in modulating brain functions, such as~     mood, learning and memory, any decrements of which have very negative impacts on the quality~     of life.~      A prior study carried out as the first study of my PhD, attempted to bridge this gap in~     knowledge and found promising results after acutely supplementing participants with a fruit~     based drink. The findings showed that there was an increased vigilance on attention related~     psychometric tasks and an increased feeling of calmness. The investigators have hypothesised~     that these cognitive enhancing effects are due to the monoamine oxidase (MAO) inhibiting~     effect of the fruit drink, our ex vivo findings support this with a 96% reduction in MAO-B~     activity.~      The aims of the current study are threefold: to extend the findings of my previous~     investigation by extending the tasks explored; to ascertain if the positive results of the~     first study are dose dependent; and to investigate whether a lower dose can facilitate~     greater changes in behaviour.~   "
149801|NCT01605669|"~     According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with~     asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE)~     performed annually for severe disease, every 1-2 years for moderate disease and every 3-5~     years for mild disease. This results in a multitude of screening studies in the investigators~     patient population. 3M has developed a new stethoscope and phonocardiography software capable~     of identifying the peak intensity of the AS murmur and tracking it as it moves towards the~     second heart sound potentially indicating increasing severity of disease. Currently there~     exists no data to demonstrate that the aortic stenosis acceleration index (ASAI) correlates~     to disease severity or progression of disease. The ASAI measures the timing of the peak~     intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1)~     where s1 is the first heart sound; S2 is the second heart sound and x with the time between~     S1 and the peak intensity of the murmur. In this study the investigators propose to correlate~     the ASAI to standard TTE measurements of aortic stenosis severity.~   "
149802|NCT01605656|"~     The goal of this study is to better understand the factors that might prevent HIV-positive~     women from having routine pap smear screenings. Researchers also want to learn what might~     make it easier or encourage women to have these screenings.~   "
149803|NCT01605643|"~     Use of tobacco is very high among Alaska Native women. The investigators are conducting a~     three phase study. The first phase will examine biomarkers of tobacco exposure in pregnant~     women and their newborns. The second phase is a qualitative study to translate the biomarker~     findings into intervention messages. The third phase is a pilot of the biomarker feedback~     intervention compared with a control condition.~   "
149804|NCT01605630|"~     The no show rate for mammography screening is high among Navajo women. One barrier to~     preventive screening is a lack of cancer literacy including low knowledge and cultural~     attitudes (e.g., fatalism) about screening. The investigators will examine the potential~     feasibility and acceptability of a cancer literacy intervention for families of Navajo women~     who have no showed for three consecutive times to mammography screening who have never or~     rarely been screened in the past.~   "
149805|NCT01605617|"~     The investigators are studying two FDA-approved modalities used to treat overactive bladder~     to determine if they improve overactive bladder with or without urge incontinence when used~     together rather than separately, percutaneous tibial nerve stimulation (PTNS) versus PTNS and~     fesoterodine fumarate.~   "
149806|NCT01605604|"~     The pupose of the study is to determine the effectiveness of the Buddhist integrated group~     intervention improve the mindfulness in adolescents by a randomized controlled trial.The~     study divede the adolescents in two groups group A recieved the 8 time Buddhist group~     interventions.Group recieved nothing.The measurement were done pre and post intervention at~     week1 and week8.The mindfulness score ,the EQ,the MASS score were compared between both~     groups.~   "
149807|NCT01605591|"~     The purpose of this study is to comparing the effects of different double-lumen endotracheal~     tube's bending type in tracheal intubation.~   "
149808|NCT01605578|"~     The purpose of this study is to compare, in healthy women, the adipose tissue composition~     between abdomen and thigh and then determine whether differences exist independently of the~     state of obesity.~      The findings of this study may help to explain the mechanism contributing to a beneficial~     role of gluteo-femoral fat contrasting with a deleterious role of abdominal fat on~     cardiovascular and metabolic dysfunctions.~   "
149809|NCT01605565|"~     Cystic fibrosis (CF) is characterized by airway inflammation and infection leading to~     progressive destruction of lungs. One of the most important abnormalities in CF is an~     abnormal processing of the mutated CFTR protein through the endoplasmic reticulum that causes~     abnormal location or even absence of the protein at the apical plasma membrane of airway~     epithelial cells. This abnormality results in a marked dehydration of the airway surface~     fluid, decreased mucus transport and airway obstruction. Nevertheless, the events that occur~     very early during the progression of the disease at the airway level in infants are not~     known. At cellular level, it has also been reported that the CFTR expression and localization~     could be related to the differentiation state of the airway epithelium. Furthermore, it has~     been reported that gap junctions could be involved in dysregulate inflammation process. In CF~     infants, many answers are still lacking. For a better understanding of the early stages of~     cystic fibrosis, it is of major interest to study respiratory epithelial cells obtained as~     early as possible. In 15 CF infants and 15 control infants, a nasal brushing will be~     performed by means of a soft sterile cytology brush. Samples will be used for cytological and~     functional studies: ciliary beating frequency, cAMP-dependent chloride efflux, potassium~     efflux, tight and gap junctions functionalities. These studies will be done in basal~     conditions and will be repeated after activation of the nasal epithelial cells by the~     bacteria, such as Staphylococcus aureus, which can be found very early in the course of CF~     disease.~   "
155314|NCT01533298|"~     The purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in~     comparison to SmofKabiven peripheral in postoperative patients requiring parenteral~     nutrition.~   "
149812|NCT01605526|"~     This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and~     efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma.~     Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of~     each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each~     cycle for up to 6 cycles.~   "
149813|NCT01605513|"~     The purpose of this study is to determine whether PEG-IFN-SA is safe, tolerant and effective~     in the treatment of HCV patients.~   "
149814|NCT01605500|"~     The purpose of this study is to determine whether the alert tones emitted by the latest~     generation of Medtronic implantable cardioverter-defibrillators (ICDs) are audible to~     patients.~      ICD patients can have difficulties hearing the beeps, which are designed to notify patients~     of possible lead or generator malfunction. In fact, the only published study of this issue,~     conducted at Englewood Hospital and Medical Center, revealed that only 50% of patients with~     older Medtronic devices were able to hear alerts. Since then, modifications to the alert have~     been made by Medtronic. This study will establish the real-world value of these changes and~     also provide useful in vivo information regarding the validity of the in vitro techniques~     which have been used thus far to design the Patient Alert feature.~   "
149815|NCT01605487|"~     Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg~     doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier~     element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany)~     will be used. This allows skin exposure to 12 different temperatures from 4 to 42 °C~     simultaneously in a standardized and reproducible way and thus the determination of~     individual temperature and/or stimulation time thresholds.~      In addition mediators related from activated must cells such as histamine, PAF, PGD2 should~     be identified in the period between the application of stimulus and the appearance of~     symptoms of cold urticaria and should be characterized qualitatively and quantitatively.~   "
149816|NCT01605474|"~     This study examines whether outpatient pre-induction cervical ripening improves patient~     satisfaction and is safe and effective.~   "
149817|NCT01605461|"~     Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose~     of [14C]-BI 207127 and to characterize the metabolic profile following single dose~     administration.~   "
149818|NCT01605448|"~     The investigators are investigating the benefits of a mind/body intervention, Mindfulness~     Based Stress Reduction, for adults with Mild Cognitive Impairment.~   "
149819|NCT01605435|"~     Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting~     (sarcopenia) and unintentional weight loss. There are currently no approved therapies for~     frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the~     brain. The purpose of this study is to determine the optimal subcutaneous ghrelin dose as a~     potential intervention for frail elderly individuals. We will examine food intake and~     metabolic parameters after placebo and ghrelin administration at three escalating~     subcutaneously administered doses.~   "
149820|NCT01605422|"~     Dietary pulses (beans, peas, chickpeas, and lentils), more commonly known as legumes, are~     generally recognized as healthy components of the diet. Canada's Food Guide encourages~     consumptions of meat alternatives, such as beans more often; and the dietary guidelines for~     Americans both recommend consumption of 3 cups of legumes per week. However, there remains~     insufficient information on the usefulness of these foods in protecting heart health. To~     improve evidence-based guidance for dietary pulse recommendations, the investigators propose~     to conduct a systematic review of the effect of dietary pulse consumption on after-meal blood~     sugar levels, appetite, and food intake regulation to help explain their mechanism for~     improving longterm blood sugar and body weight control. The systematic review process allows~     the combining of the results from many small studies in order to arrive at a pooled estimate,~     similar to a weighted average, of the true effect. The investigators will be able to explore~     whether eating pulses has different effects between men and women, in different age groups~     and background disease states, and whether or not the effect of pulses depends on the dose~     and background diet. The findings of this proposed knowledge synthesis will help improve the~     health of Canadians through informing recommendations for the general public, as well as~     those at risk of heart disease and diabetes.~   "
149821|NCT01605409|"~     Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation~     algorithms and postcardiac arrest care have been improved there is an urgent need for~     measures leading to a higher survival rate.~      Emergency cardiopulmonary bypass (ECPB - artificial heart and lung outside the patients body)~     is a method which has shown good results in case reports and animal studies for cardiac~     arrest care.~      The study will be performed as comparison between the new treatment option of ECPB versus the~     standard of care treatment.~      Aim of our study is to determine the feasibility of ECPB installed in an emergency department~     to improve the rate of patients restoration of spontaneous circulation.~   "
149822|NCT01605396|"~     The purpose of the study is to evaluate the progression free survival (PFS) of ridaforolimus,~     dalotuzumab and exemestane (R/D/E) compared to the combination of ridaforolimus and~     exemestane (R/E) in post-menopausal participants with breast cancer.~   "
149823|NCT01605383|"~     The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral~     head in comparison to the standard treatment of isolated core decompression.~      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by ex-vivo expanded autologous~     mesenchymal stem cells fixed in allogenic bone tissue.~      The working hypothesis proposes that the tissue engineering is a valid and useful technique~     to achieve bone regeneration, avoiding the progression to collapse of the femoral head.~   "
149824|NCT01605370|"~     The purpose of this study is to evaluate if a drug called nebivolol can reverse inappropriate~     left ventricular mass (LVM) when compared to the standard of care drug metoprolol.~   "
149848|NCT01605058|"~     The purpose of this study is to evaluate the visual performance of a trifocal intraocular~     lens at distance, near and intermediate viewing, by way of visual acuity measurement,~     contrast sensitivity.~      Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.~   "
149849|NCT01605045|"~     The aim of this study is to evaluate the effects of screening using the fluoroscopy-save~     function on reduction of radiation exposure and quality of angiogram during cardiac~     catheterization when compared to traditional cinematography-guided coronary angiography.~   "
149825|NCT01605357|"~     Cerebral edema is seen heterogenous group of neurological disease states that mainly fall~     under the categories of metabolic, infectious, neoplasia, cerebrovascular, and traumatic~     brain injury disease states. Regardless of the driving force, cerebral edema is defined as~     the accumulation of fluid in the brain's intracellular and extracellular spaces. This occurs~     secondary to alterations in the complex interplay between four distinct fluid compartments~     within the cranium. In any human cranium; fluid is contained in the blood, the cerebrospinal~     fluid, interstitial fluid of the brain parenchyma, and the intracellular fluid of the neurons~     and glia. Fluid movement occurs normally between these compartments and depends on specific~     concentrations of solutes (such as sodium) and water. In brain-injured states, the normal~     regulation of this process is disturbed and cerebral edema can develop. Cerebral edema leads~     to increased intracranial pressure and mortality secondary to brain tissue compression, given~     the confines of the fixed-volume cranium. Additionally, secondary neuronal dysfunction or~     death can occur at the cellular level secondary to the disruption of ion gradients that~     control metabolism and function.~      While studies utilizing bolus dosing of hyperosmolar therapy to target signs or symptoms of~     increased intracranial pressure secondary to cerebral edema are numerous, there is a paucity~     of studies relating to continuous infusion of hyperosmolar therapy for targeted sustained~     hypernatremia for the prevention and treatment of cerebral edema. The investigators~     hypothesize that induced, sustained hypernatremia following traumatic brain injury will~     decrease the rate of cerebral edema formation and improve patient outcomes.~   "
149826|NCT01605344|"~     The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetic~     profile of irinotecan and SN-38. To further evaluate the safety of atorvastatin in~     combination with FOLFIRI. To further evaluate the safety and of irinotecan in combination~     with atorvastatin.~   "
149827|NCT01605331|"~     As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH~     deficiency has been known to improve metabolic impairment and quality of life. Patients,~     however, do have to tolerate daily injections of GH (rhGH).~   "
149828|NCT01605318|"~     This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles,~     once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with~     metastatic colorectal cancer who have been previously treated with at least one prior~     irinotecan-containing regimen. The study is being done to evaluate whether the study drug is~     safe and tolerable at different dose levels with these dosing schedules and to obtain~     preliminary information on its efficacy.~   "
149829|NCT01605305|"~     The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to~     progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic~     esophagus.~   "
149830|NCT01605292|"~     Radial artery access for cardiac catheterization can require multiple attempts. Multiple~     attempts increase the time required, patient discomfort, and the risk of arterial spasm.~     Ultrasound guidance has been shown in other studies to reduce the number of attempts and~     complications in central venous and femoral artery access. This study will test if the~     addition of ultrasound guidance reduces the number of attempts and time required to access~     the radial artery.~   "
149831|NCT01605279|"~     Low systemic flow as measured by Doppler-echocardiography has been associated with poor~     neurological outcome. Yet, it has not been systematically evaluated whether the treatment of~     this hemodynamic condition is beneficial or not. This study aims to evaluate if treating low~     systemic flow in preterm infants with dobutamine has any effect on the cerebral circulation~     and in newborn prognosis.~   "
149832|NCT01605266|"~     INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic,~     serologic and environmental factors contributing to nephrotic syndrome and disease~     progression.~   "
149833|NCT01605253|"~     The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is~     effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep~     disturbance. The investigators will also examine the impact of treatment on sleep patterns,~     memory recall bias, and level of inflammatory markers (cytokines). The investigators predict~     eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms,~     memory recall bias, and level of inflammatory markers.~   "
149834|NCT01605240|"~     For simple fractures treated in the emergency department with cast immobilisation only,~     ibuprofen has been shown to be superior to, or a least or equivalent to codeine with less~     side effects. These and other studies have commented that their results may not be applicable~     to children who have fractures that require reduction. There is currently no literature on~     the management of postoperative pain following reduction of paediatric fractures. The~     investigators aim therefore is to investigate whether either of the two most commonly~     prescribed analgesics is superior to the other for postoperative pain management following~     closed reductions of paediatric forearm fractures. Also, if one agent has more side effects~     than the other.~   "
149835|NCT01605227|"~     This study will evaluate the effect of cabozantinib compared to prednisone on overall~     survival in men with previously treated metastatic castration-resistant prostate cancer with~     bone-dominant disease who have experienced disease progression on docetaxel-containing~     chemotherapy and abiraterone or MDV3100.~   "
149850|NCT01605032|"~     This phase II trial studies how well busulfan, melphalan, and bortezomib before first-line~     stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy~     before a peripheral blood stem cell transplant may stop the growth of cancer cells by~     stopping them from dividing or killing them. After treatment, stem cells are collected from~     the patient's blood and stored. The stem cells are then returned to the patient to replace~     the blood-forming cells that were destroyed by the chemotherapy.~   "
149851|NCT01605019|"~     The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an~     FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks~     in blood vessels during surgery.~      This study is evaluating CoSeal™ when it is applied to various areas of the heart during the~     surgery to implant a Left Ventricular Assist Device (LVAD). the investigators are looking for~     evidence which indicates that CoSeal™ may be useful in reducing or stopping bleeding, the~     occurrence of micro emboli (small particles of air or blood), and the formation of cardiac~     adhesions (scar tissue strands that may form around the heart in the area of a previous LVAD~     operation) in patients who undergo LVAD implantation surgery.~   "
149836|NCT01605214|"~     Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality~     following lung transplant and is characterized by acute lung injury and capillary leak~     leading to an increase in extravascular lung water index (ELWI) and impaired graft function.~     PGD has many features in common with acute respiratory distress syndrome (ARDS). PGD may be~     life-threatening and can also lead to impaired long term lung function. In ARDS, a~     restrictive fluid strategy has been associated with an improvement in lung function and~     outcomes. Accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid~     management and limiting the extent of ELWI that accumulates in the setting of PGD are~     lacking. Using transpulmonary thermodilution to estimate ELWI and the pulmonary permeability~     index (PPI) represents a novel approach to fluid management, which has been used in patients~     with ARDS, but to date not in the transplant setting. To determine if these measurements may~     better guide the management of lung transplant patients, the investigators first wish to~     establish whether these methods are able to predict the onset of clinical pulmonary edema~     earlier, whether they correlated with traditional markers of PGD, and whether they may be~     useful for predicting outcomes.~      AIM 1: The investigators will evaluate the correlation between ELWI and current surrogates of~     pulmonary edema in lung transplant patients with and without Primary Graft Dysfunction (PGD)~      AIM 2: The investigators will correlate the use of ELWI and PPI to determine the presence and~     severity of PGD.~      AIM 3: a) The investigators will determine whether early measurements of ELWI and PPI can~     predict the onset of PGD.~      b) Across different strata of PGD, the investigators will determine whether ELWI and PPI have~     a differential effect on duration of mechanical ventilation.~      The results of the study will be used for the following:~        1. Provide the rationale for routine monitoring of ELWI to detect PGD if found to be more~          discriminatory and have a stronger association with outcome compared to the current gold~          standard.~        2. Provide the means of early identification of those as risk of developing PGD in order to~          guide management decisions or future therapeutic interventions aimed at preventing or~          treating PGD.~        3. Provide the requisite groundwork for a clinical trial comparing the effects of an~          ELWI-driven protocol versus usual care on ICU outcomes in lung transplant recipients.~   "
149837|NCT01605201|"~     The purpose of this study is to investigate the safety and feasibility of implanting an~     engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes~     within a collagen type I/III membrane into the cartilage defect on the femoral condyle and/or~     trochlea of the knee after a traumatic injury.~   "
149838|NCT01605188|"~     The aim of our study is to prospectively identify, at diagnosis, factors predictive of~     non-response or loss of response in patients with inflammatory bowel disease treated with~     anti-TNF.~   "
149839|NCT01605175|"~     The aim of this study is to prospectively identify, at diagnosis of the disease, factors~     predictive of mucosal healing in patients with inflammatory bowel disease treated with~     anti-TNF.~   "
149840|NCT01605162|"~     This is a Phase 2, open-label, multicenter study to assess the PFS-6m of E7016 at the~     selected dose of 320-mg once daily (QD) in combination with 150-mg/m2 of Temozolomide (TMZ)~     in subjects with wt BRAF Stage IV or unresectable Stage III melanoma with disease~     progression. Eligible subjects must have measurable disease according to Response Evaluation~     Criteria in Solid Tumors (RECIST).~   "
149841|NCT01605149|"~     Type 1 Diabetes Mellitus is a disease that has an effect on bone mineral density. It is~     unclear how and when it effects the bone density. The investigators are studying the effects~     of diabetes on bone mass compared to children without diabetes.~   "
149842|NCT01605136|"~     This is a randomized placebo-controlled study to be conducted in two parallel study arms for~     a six month period (three doses). Between 75 and 100 eligible patients will be enrolled.~     Patients will receive afamelanotide (16 mg implants) or placebo according to the following~     dosing regimen:~        -  Group A will be administered afamelanotide implants on Days 0, 60 and 120~        -  Group B will be administered placebo implants on Days 0, 60 and 120~      The number and severity of phototoxic reactions, the type and duration of sun exposure,~     treatment-emergent adverse events and the use of concomitant medication will be recorded by~     patients in study diaries between Days 0 and 180. Quality of life will be measured using the~     DLQI and EPP-QoL at Days 0, 60, 120 and 180. Participants will visit the clinic on Days 60,~     120 and 180 for assessments of adverse events.~      A subset of patients will be photoprovoked on the lower back and dorsal surface of the hand~     and the minimal symptom dose (MSD) will be determined on Days 0, 30, 60, 90 and 120.~   "
149843|NCT01605123|"~     The investigators hypothesize that cardiovascular and metabolic alterations due to obesity~     already manifest at childhood age.~      To identify these alterations and risk factors, the investigators have established a cohort~     of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of~     cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity~     and inflammation. Follow-up analyses are planned after 2 years (completed) and additionally~     after 5, 7 and 9 years.~      In addition, the investigators will assess the effects of increased physical activity and~     exercise on cardiovascular function.~   "
149844|NCT01605110|"~     The aim of this study is to test the effect of Hyperbaric Oxygen Therapy) HBOT (100% oxygen;~     2.0 ATA; 90 minute total exposure) and compare against a hyperbaric sham treatment (HBST)~     (patient's breathing room air; 2.0 ATA; 90 minute exposure) in reducing edema and ecchymosis.~     HBOT will be applied as a single pre-operative and a single post-operative treatment for~     patients undergoing eyelid surgery. Briefly, patients will be exposed to HBOT 2-4 hours prior~     to undergoing surgery, 2-4 hours post-surgery and healing will be assessed at day 3, 10, 21,~     30 & 90 days after surgery. Edema and ecchymosis will be assessed in a time series to~     determine the extent that HBOT reduces these clinical signs. The primary null hypothesis to~     test will be that no differences in scores will exist between treatment and control at day 3,~     10 & 21 post-surgery. A secondary null hypothesis to test is the time required to change a~     score will be no different between the two groups.~      HBOT=hyperbaric oxygen therapy; HBST=hyperbaric sham treatment~   "
149845|NCT01605097|"~     This study will investigate the feasibility of using technology of ultrasound guided HDR~     brachytherapy to focally increase dose to regions within the prostate that are heavily~     infiltrated with cancer. Such regions, referred to as dominant intraprostatic lesions (DIL)~     can be visualized using diffusion contrast enhanced MRI employing an endo-rectal coil. The~     magnetic resonance (MR) images can be fused with the planning transrectal ultrasound (TRUS)~     prior to the brachytherapy procedure to design a dose distribution that will encompass the~     malignant volume with higher than the prescription dose. By its nature, brachytherapy has~     subvolumes that receive (for example)125% of the prescription dose or 150% of the~     prescription dose. With TRUS-guided and TRUS-planned HDR these areas can be manipulated to~     coincide with the DIL. The limit of dose escalation has been reached at whole prostate~     external beam doses of 81-86 Gy and still failure rates for intermediate and high risk~     disease are unacceptable. There is much interest in focal dose escalation and TRUS-guided HDR~     brachytherapy is perfectly suited to achieving this.~   "
149846|NCT01605084|"~     The purpose of this study is to determine the proportion of subjects with HIV-1 RNA < 50 c/mL~     at Week 48 in patients who failed their first line therapy containing a non-nucleoside~     reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor~   "
149852|NCT01605006|"~     This post-approval study will follow 60 participants who have ALS, documented chronic~     hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical~     implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who~     are successfully implanted with the device will use it for daily diaphragm conditioning~     sessions. Participants will be followed for at least two years (until the last enrolled~     participant reaches the 2-year follow-up visit). Safety and probable benefit outcome measures~     will be assessed.~   "
149853|NCT01604993|"~     The purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates~     on aortic augmentation index, brachial and aortic blood pressures, and subendocardial~     viability ration (SEVR).~   "
149854|NCT01604980|"~     Minimal data are available on protein requirements throughout the lifespan. Currently~     available recommendations are based on nitrogen balance data. The limitations of the nitrogen~     balance method have been well described. Importantly, nitrogen balanced underestimates~     requirements.~      The current DRI requirement for healthy adult males is based on the reanalysis of the~     nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by~     Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83~     (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group~     estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2~     g/kg/day (mean and RDA).~      Currently there are no studies on protein requirement in the elderly. In a recent nutrition~     survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70~     years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents~     about 15 % of calories. Depending on the calculations used for ideal body weight some older~     adults could be getting higher or lower than requirement. There is no scientifically derived~     protein estimate for older adults. Therefore there is a need to measurer protein requirement~     in that population.~      The goal of this study therefore is to measure the protein requirement of female elderly~     subjects >75 years using the IAAO technique.~   "
149855|NCT01604954|"~     Weight management is a critical issue in developed countries where the prevalence of obesity~     is always increasing. While the mismatch of energy intake and energy expenditure is~     recognized as a leading cause of obesity, knowledge related to the determinants of healthy~     eating patterns are still an important issue to further address. Various nutrition-education~     campaigns have been implemented as a way to increase knowledge about healthy foods and~     facilitate the adoption of better eating behaviors. There is currently social and politic~     pressure on health authorities to increase availability of nutrition information as a way to~     tackle the obesity epidemic. Does nutrition information on food labels really contribute to~     improving dietary intake among the population and to helping them to better manage their body~     weight? Some evidence suggests that describing foods as healthy might have unintended~     enhancement effects on the acute amount of food and calories consumed. A better understanding~     of how and why nutrient and calorie labels influence acute and chronic intake is thus needed.~     This study investigate how providing nutritional information on food labels influences intake~     and eating-related variables over a 10-day period among women characterized by varying levels~     of adiposity. As it has never been investigated before, the present research will provide~     important knowledge on the long-term impacts of different food labeling strategies on the~     regulation of food intake. It will also help to determine whether weight status could~     influence the effects of perceptions about foods on intake, so that the investigators can~     identify individuals who mostly tend to overeat in specific situations. Consumer advocacy~     organizations are urging government to adopt policies regarding food labeling. Such research~     is thus of great relevance for the promotion of healthy body weight at the population level,~     as it will clearly contribute to assess how food labels should be used by health governing~     bodies in the context of the obesity epidemic.~   "
149856|NCT01604941|"~     The purpose of this study is to evaluate SSP-004184AQ in patients with transfusional iron~     overload whose primary diagnosis is hereditary or congenital anemia.~      SSP-004184AQ is an iron chelator under development for chronic daily oral administration to~     patients with transfusional iron overload.~   "
149857|NCT01604928|"~     The study is intended to test efficacy, safety and tolerability of two doses of YM178 against~     placebo and tolterodine to treat patients with symptoms of over active bladder.~   "
149858|NCT01604915|"~     Single shot caudal epidural block is one of the most widespread technique for pediatric pain~     management after infraumbilical surgical procedures.~      However, in a significant proportion of patients, despite good initial analgesia from a~     caudal block with local anesthetic, pain develops after the block resolves.~      In order to decrease postoperative analgesic requirements after caudal block, various drugs~     such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been~     investigated. However, their use has been limited by adverse effects in children.~      Recently, many study suggested that epidurally administered dexamethasone could reduce the~     incidence and severity of postoperative pain in adults. But there is no study concerning the~     use of dexamethasone, as an adjuvant agent for the caudal epidural block in children.~      The investigators performed prospective randomized double-blind study to examine the~     analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal~     analgesia on postoperative pain control in pediatric patients undergoing orchiopexy.~      80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this prospective,~     randomized, double-blinded study. After inhalation induction of general anesthesia, caudal~     block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg~     added to ropivacaine 0.15% 1.5ml/kg was administered to Group R , dexamethasone 0.1mg/kg~     added to ropivacaine 0.15% 1.5ml/kg to Group DR. Postoperative pain was recorded at 30min and~     1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) and Faces Legs~     Activity Cry Consolability tool (FLACC, 0-10). Participants will be followed for the duration~     of hospital stay, an expected average of 3 hours.~      After discharge, rescue analgesic consumption, pain scores, and adverse effects were~     evaluated for 24h.~      The time to first supplemental oral analgesic medication demand was defined as the time from~     the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation.~     Twenty-four hours after surgery, reports of delayed side effects and demands for rescue~     analgesics from the child were gathered from parents via a telephone interview.~   "
149859|NCT01604902|"~     PURPOSE - The purpose of this study is to identify and determine miRNA expression and their~     targets before and during biological treatment of psoriatic patients.~      HYPOTHESIS - Changes in the expression of specific miRNAs play an important role for the~     cytokine expression profile seen in lesional psoriatic skin. miRNAs may therefore serve as a~     potential target for future anti-psoriatic treatment as well as possible predictors of~     biological treatment response.~      PERSPECTIVES - The results from this novel research project will increase the investigators~     understanding of the underlying mechanisms leading to psoriasis. Furthermore it is possible~     that predictors of treatment response can be identified. Identification of biomarkers~     predicting treatment outcome will individualize patient care, reduce number of treatment~     failures and thereby have a tremendous socio-economic impact and increase the patients~     quality of life.~   "
149860|NCT01604889|"~     The study design includes an open-label, dose escalation phase followed by a blinded,~     randomized phase, which combines INCB024360 (an oral IDO1 inhibitor) with an approved therapy~     and compares to approved therapy plus placebo in metastatic melanoma patients.~   "
149861|NCT01604876|"~     The purpose of this clinical trial is to investigate whether light therapy is a suitable~     treatment option for depression and insomnia in Parkinson's disease.~   "
159655|NCT01476332|"~     The purpose of this two-part study is to evaluate safety, tolerability and pharmacokinetics~     of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers.~   "
149864|NCT01604837|"~     The recommended entry angle for superior hypogastric plexus block is different among~     references, and there is a need for suggesting a more accurate entry angle for this~     procedure. The investigators are trying to evaluate the entry angle for superior hypogastric~     plexus block by measuring these angle on the computed tomography image and apply these angle~     to the real patients.~   "
149865|NCT01604824|"~     The purpose of this study is to assess the pharmacodynamic (PD) effect of alirocumab on serum~     low-density lipoprotein cholesterol (LDL-C) in patients with autosomal dominant~     hypercholesterolemia (ADH) and gain-of-function mutations (GOFm) in 1 or both alleles of the~     proprotein convertase subtilisin/kexin type 9 (PCSK9) gene or with a loss-of-function~     mutation (LOFm) in 1 or more alleles of the apolipoprotein B-100 gene (apoB).~   "
149866|NCT01604811|"~     Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent~     published works pointed out that urine and serum markers could be used for detection of~     prostatic inflammation.~      The aim of the study is to assess the activity on inflammation biomarkers (serum and urine~     inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the~     treatment of urinary symptoms related to BPH.~      The potential links between serum and urinary markers of inflammation and BPH clinical~     symptoms at baseline and on treatment will be explored.~   "
149867|NCT01604798|"~     No ideal serum biomarker currently exists for the early diagnosis of colorectal cancer (CRC).~     Therefore, it is urgent that accurate and reliable serum biomarkers be identified.~   "
149868|NCT01604785|"~     There has been little advancement in abortive migraine therapies in recent decades, and few~     proven treatments exist for acute migraine, particularly in children. Propofol, a general~     anesthetic, has been suggested to be effective for the treatment of migraine headaches in~     adults when used in subanesthetic doses (lower doses than those used for anesthesia or~     sedation). Initial retrospective review of the investigators experience with propofol for~     migraine in children suggests that it is safe and may be more effective than standard~     treatments used in the emergency department. The investigators retrospective series had a~     small subject population and a larger study is needed to compare propofol to current~     available treatments.~      All subjects presenting to the pediatric emergency department with signs/symptoms of migraine~     headache will be screened for the study. Subjects who are eligible will be provided~     information about the study and consent/assent forms from a member of the research team, and~     asked whether they are interested in participating.~      All study subjects will receive acetaminophen (Tylenol) or ibuprofen (Motrin) for their~     headache if they have not already tried these first-line treatments at home; those with~     persistent symptoms requiring further treatment who consent to participate in the study will~     be randomized to receive either standard treatment or propofol. Standard treatment currently~     consists of a cocktail of medications that include anti-nausea medicines (metoclopramide~     and diphenhydramine) and an analgesic (ketorolac) as well as intravenous fluids. Subjects~     assigned to the experimental group (Propofol) will receive the same intravenous fluids and up~     to five doses of propofol. All subjects will undergo assessment of their pain (self-rated on~     a scale from 0-10) before and after treatment. During treatment they will have close~     monitoring of their vital signs. No additional laboratory tests or procedures are involved.~     Post-visit clinical data will be collected from the subject's medical record and subjects~     will be called by telephone 24-48 hours after discharge from the emergency department to ask~     how they are doing and whether they required any additional treatments such as home~     medications or by other medical professionals other than OHSU.~      The study data will be presented in summary tables that outline subjects' clinical~     presentation prior to treatments, and response to study drug during their visit. The main~     variables of interest include effectiveness (determined as a reduction in self-reported pain~     score), length of stay in the pediatric emergency department, recurrent headache requiring~     emergency treatment within 24 hours and whether any adverse effects occur. These will be~     compared between the 2 study groups with basic statistics.~   "
149869|NCT01604772|"~     This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with~     progressive, recurrent, or metastatic adenoid cyst carcinoma (cancer). Akt inhibitor MK2206~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
149870|NCT01604759|"~     In this study the investigators are conducting research to determine whether a new optical~     device using polarization reflectance spectroscopy can help doctors or dentists identify~     abnormalities in the mouth that require follow-up. To establish this, measurements are needed~     from a large number of individuals with different abnormalities in their mouth.~      The investigators believe the proposed approach has potential to improve and enable mass~     screening for precancerous and early cancers of the oral cavity by improving the predictive~     value of oral cavity exams, particularly for less experienced practitioners.~      The information from this study will be compared to results from the pathology report of the~     tissue taken from your mouth.~      Hypothesis:~        1. Polarized reflectance spectroscopy can distinguish high-risk oral lesion from normal and~          reactive oral lesions.~        2. Polarized reflectance spectroscopy can capture low-grade oral lesions that have~          characteristics associated with a high risk of progression to cancer.~   "
149871|NCT01604746|"~     The purpose of this study is to verify the long-term safety of a 2.5 µg, adjuvanted~     (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine.~   "
149872|NCT01604733|"~     Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in~     patients taking lipid lowering agents for at least 3 months ( with no drug change or dose~     amendment for a minimum of 6 weeks).~   "
149873|NCT01604720|"~     Sample size definition provides important information, allowing the groundwork for~     transparent reporting. The sample predefinition allows the trial to be large enough to be~     able to address the question that is being asked.~      The aim of the present study is to assess, in all the randomized controlled trials (RCT)~     included in the Cochrane Hepato-Biliary Group (CHBG) systematic reviews, the quality of~     reporting sample size the accuracy of the calculations, the accuracy of the a priori~     assumptions and the effect on the agreement with pooled results in meta-analyses.~   "
149874|NCT01604707|"~     Background An increasing number of patients are suffering from stress-related symptoms and~     diseases. No scientific studies have examined the effects of Medical yoga on stress-related~     symptoms in patients in primary care. The purpose of this study was to evaluate Medical yoga~     treatment in patients with stress-related symptoms and diagnosis in primary health care.~      Methods A randomized, controlled study was performed at a primary health care centre in~     Sweden from March to June 2011. Patients were randomly allocated to a control group receiving~     standard care, or a yoga group treated with Medical yoga for 1 hour, once a week, over a~     12-week period in addition to the standard care. A total of 37 men and women, mean age 53±12~     years, seeking care for stress-related symptoms at the primary health care centre were~     included and followed up after the 12-week study period. General stress level (measured using~     Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety~     and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia~     Severity Index (ISI)), pain (visual analogue scale (VAS)) and overall health status (Euro~     Quality of Life-VAS (EQ-VAS)) were measured before and after 12 weeks.~   "
151290|NCT01586195|"~     This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf~     (vemurafenib) in participants with locally-advanced, unresectable, stage IIIc or metastatic~     melanoma and activating exon 15 BRAF mutations other than V600E.~   "
149875|NCT01604694|"~     Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently~     more and more anaesthetists are turning to regional analgesia for anterior abdominal wall~     surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound~     guidance.~      The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in~     post operative period of abdominoplasty.~   "
149876|NCT01604681|"~     The purpose of this study is to evaluate the effect of supplementation with flaxseed oil~     combined with a nutritional counseling in reducing cardiovascular risk factors in~     homocysteine , biomarkers of inflammation, oxidative stress, improving quality of life and~     cognitive decline in hypertensive and dyslipidemic genotyped for the C677T and A1298C~     polymorphisms of methylenetetrahydrofolate reductase gene.~   "
149877|NCT01604668|"~     There is no study hypothesis. The purpose of this study is to compare the accuracy of the: 1)~     SpHb (Radical 7 Pulse Co-Oximetry with SpHb™) RevF sensor (currently marketed), 2) the SpHb~     RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed~     version) in patients undergoing spine surgery.~   "
149878|NCT01604655|"~     The purpose of this study is to determine the best initial test in patients admitted to the~     hospital complaining of chest pain.~   "
149879|NCT01604642|"~     The goal of the investigators study is to investigate the role of a hormone named Activin A~     (ActA) in the development of the skeletal muscle atrophy caused by cancer. According to the~     investigators hypothesis, ActA could be released by the tumor and activate a muscle atrophy~     gene program. To answer this question, the investigators plan first to compare circulating~     levels of ActA in cancer patients with and without cachexia. In a second step, the~     investigators would like to assess whether ActA circulating levels are predictive for the~     development of cachexia and short survival.~   "
149880|NCT01604629|"~     The purpose of this study is to demonstrate that patients with Spondylarthropathies in~     remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior~     to the currently recommended dose schedule.~   "
149881|NCT01604616|"~     The purpose of the article is, to investigate the efficacy and safety of perfluorocarbon~     liquid (PFCL) ,as a short term postoperative tamponade for treating retinal detachment~     ,associated with giant retinal tears.~   "
149882|NCT01604603|"~     Background: Menstrual disturbance is the major complain in reproductive age women, the~     clinical and biochemical characteristics of women with different menstrual disturbance had~     not been well-understood. Objective: To study the clinical and biochemical characteristics of~     women with oligomenorrhea, amenorrhea, and premature ovarian failure. Method: Retrospective~     study, medical records reviewed in patients who visited to outpatient clinic of Reproductive~     Medicine in Taipei Medical University - Wan Fang Hospital form 2009 Jan. 1 to 2011 Nov. 31.~     Including criteria: Patients had sufficient medical records (anthropometric, endocrine,~     metabolic, lipid parameters) and age less than 45. Excluding criteria: (1) Women who~     experienced menarche <3 years before the beginning of the study; (2) Women who received~     hormones or drugs for major medical diseases; (3) Women who presented ovarian cysts or~     ovarian tumors, uterine abnormality; (4) Women who were >45 years old.~   "
149883|NCT01604590|"~     This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is~     being treated with bevacizumab. This study will use a new MRI technique to compare the images~     of blood vessels and tumor structure to the effectiveness of bevacizumab.~   "
149884|NCT01604577|"~     The primary research goals of this application are to characterize social factors including~     health literacy and numeracy skills of CKD patients and examine associations with knowledge,~     self-efficacy, self-care behaviors, and clinical outcomes, and to examine the impact of an~     efficient interactive educational intervention to facilitate patient-provider communication.~     The investigators will accomplish these goals by executing a cluster-randomized controlled~     trial and performing detailed analysis of baseline measures. The specific aims of this study~     are:~      Specific Aim 1: Determine the association of social factors with patient kidney knowledge,~     self-efficacy, participation in self-care behaviors, and clinical outcomes in moderate to~     advanced CKD.~      Hypothesis: In patients with CKD, low health literacy and numeracy is common and associated~     with older age, non-white race, fewer years of education, lower socioeconomic (income)~     status, less kidney knowledge, lower self-efficacy of self-care, and less adherence with~     medication and diet self-care recommendations. Low literacy/numeracy is also associated with~     higher blood pressures, more proteinuria, and more severe dysfunction of renal clearance.~      Specific Aim 2: Evaluate the impact of a tailored literacy-sensitive educational tool used~     cooperatively by physicians and patients to improve self-care and outcomes in CKD.~      Hypothesis: Utilization of a concise literacy-sensitive physician-delivered educational tool~     will be feasible and associated with higher patient kidney knowledge, self-efficacy of~     self-care and greater adherence to medication and nutrition recommendations compared to usual~     care.~   "
149885|NCT01604564|"~     The purpose of this registry is to collect information about patients in which a pouch has~     been created to improve in the future the quality of the surgery of the pouch.~   "
149886|NCT01604551|"~     Microparticles (MPs) result from plasma cell membrane remodeling and shedding after cell~     stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with~     emerging role in pathophysiology of immune and cardiovascular diseases. MPs have been~     characterized during septic shock and may contribute to dissemination of pro-inflammatory and~     procoagulant mediators. This is a prospective observational study of circulating MPs and~     blood coagulation in 100 septic shock patients admitted in 3 tertiary hospitals medical ICU~     at baseline (D1), D2, D3, D4 and D7.~   "
149887|NCT01604538|"~     RAZIONALE~      Pulmonary embolism is a complex disease, with a highly variable clincal presentation.~     Diagnosis starts with clinical probability assessment mainly based on medical history and~     rapidly available clinical data. Pulmonary embolism can be managed by emergency department,~     cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical~     management can varies based on the attitude of the attending physician.~      Diagnosis is a crucial point as it can influence short term mortality.~      OBJECTIVE~      The registry has 3 main objectives:~        1. educational objective,~        2. improvement in the knowledge of epidemiology, management and outcome of acute pulmonary~          embolism in Italy~        3. scientific objective~   "
170468|NCT01334112|"~     The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the~     treatment of unresectable/metastatic hepatocellular carcinoma (HCC)~   "
149889|NCT01604512|"~     This study will examine if MRI perfusion and PET/CT can tell growing tumor and radiation~     injury apart. MRI perfusion looks at the blood vessels in the tumor. PET/CT looks if the~     tumor cells are actively growing. The investigators will do these two tests and see which one~     is better.~      Patients will remain on study until the completion of either the MRI perfusion or PET/CT that~     are within 12 weeks of each other. After one of these scans, the patient will have no active~     interventions and will be off study.~      Optional: Restriction Spectrum Imaging (RSI) Sequence RSI sequence is an advanced way of~     looking at your brain. The scan allows doctors to see how water is moving within brain tumors~     or within brain cells. The extra sequence takes additional 4-5 minutes in the scanner. The~     RSI sequence is optional. The patient will only be asked to participate if the doctor~     believes that it will be helpful.~      Off study: Patients will remain on study until the completion of either the MRI perfusion or~     PET/CT that are within 12 weeks of each other. After one of these scans, the patient will~     have no active interventions and will be off study. Patients will obtain a standard of care~     brain MRI scan about every 2-3 months. These MRI scans will be used to track disease~     progression.~   "
149890|NCT01604499|"~     This study builds on the framework of a previously implemented color-coded food labeling~     intervention in a hospital cafeteria by testing the incremental effectiveness of providing~     employees with individual feedback and incentives for increasing healthy purchases in a 3-arm~     randomized controlled trial. The investigators hypothesize that employees assigned to receive~     feedback will increase healthy purchases more than employees who receive no contact and that~     employees who receive feedback plus incentives will increase healthy purchases more than~     those who receive feedback alone.~   "
149891|NCT01604486|"~     There is a sharp rise in the rate of coronary heart disease diagnoses and chest pain~     consultations in the 90 days before a first heart attack. There is some evidence that chest~     pain and angina symptoms in this period have a beneficial effect on heart attack outcomes in~     hospital and shortly after discharge. However, the available evidence is lacking in three key~     areas. First it is based on a retrospective patient report of symptoms after the heart attack~     has occurred; this means that patients are required to survive their heart attack and may~     make errors when reporting prior symptoms. Second, evidence for an effect on longer term~     outcomes, and coronary outcomes in particular (e.g. coronary death, further heart attacks)~     are unknown. Third, there is conflicting evidence that these effects might differ by age, in~     men and women, and according to treatment in hospital.~      The investigators hope to address the limitations in the evidence by performing a large,~     prospective study of the occurrence, timing and effect of different types of symptoms and~     disease diagnoses occurring before heart attack.~      The investigators hypothesise that prospectively collected, clinical measures of chest pain~     symptoms and cardiovascular diagnoses in primary care will have a beneficial effect on short~     term coronary mortality and may have a beneficial effect on longer term coronary outcomes.~   "
149892|NCT01604473|"~     An arterio-venous fistula is a surgical procedure that supports access for people undergoing~     hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to~     better understand the factors that contribute to the successful maturation of an~     arterio-venous fistula. A primary aim of this study is to see if endothelial function (the~     biochemical events initiated by cells lining the arteries) is associated with successful~     maturation. Other aims include determining if pro-inflammatory markers in the blood or~     evidence of gene expression are associated with successful maturation.~   "
149893|NCT01604460|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part V is comparing~     standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso~     wrap in full term infants from resuscitation to one hour after birth.~   "
149894|NCT01604447|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part V is comparing use of~     a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following~     removal from their incubator to assist with temperature regulation.~   "
149895|NCT01604434|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part III is for preterm/low~     birth weight infants with or without a plastic torso wrap during the first hour after birth~     to assist with temperature regulation during placement in an incubator.~   "
149896|NCT01604421|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part II is for preterm/low~     birth weight infant with or without plastic head cover used from 1 hour after birth until~     discharge or 24 hours after birth to assist with temperature regulation.~   "
149897|NCT01604408|"~     LY2495655 is an investigational drug being tested for muscle wasting.~   "
149898|NCT01604395|"~     The purpose of this study is to evaluate the long-term safety and effectiveness of growth~     hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS~     (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS~     (Idiopathic Short Stature).~   "
149899|NCT01604382|"~     Patients undergoing elective total knee arthroplasty are randomized to either intrathecal~     anesthesia, wound infiltration with local anesthetics and standardized postoperative care (NA~     = neuraxial anesthesia) or general anesthesia, intraoperative glucocorticoids with~     accelerated postoperative care principles (GA). The study hypothesis is that GA would reduce~     length-of-hospital stay. Outcome variables are postoperative nausea and vomiting,~     mobilization rate, pain, requirement of analgesics, and length-of-hospital stay.~   "
149900|NCT01604369|"~     The hypothesis of the present study is to evaluate cryoablation(cooling of the tissue) as~     standard therapy of common atrial flutter,focusing on efficacy, feasibility, procedure time,~     and patient content.~      The purpose of this study is to determine whether cryoablation, performed only by operators~     experienced in cryothermic ablation is effective and safe in the treatment of atrial flutter.~   "
149901|NCT01604356|"~     Retinitis Pigmentosa (RP) patients are interested in trying alternative therapies to attempt~     to slow, halt or reverse the retinal disease process, and claim success with some approaches~     such as acupuncture, but this potential treatment has not been put to the test of objective,~     rigorous scientific study conducted in western society. In this pilot study, the~     investigators aim to evaluate an acupuncture treatment tailored to the RP population for its~     feasibility to improve visual function, specifically visual field and dark adaptation. The~     study results may provide a basis for eye care providers' recommendations to RP patients~     regarding whether to consider acupuncture as a potential treatment modality. If our~     hypotheses regarding improvements in vision beyond typical test variability are supported,~     our future research goals include the conduct of a larger clinical trial with involving~     randomization and a placebo control for acupuncture in RP.~   "
149902|NCT01604343|"~     The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction~     of the signs and symptoms of rheumatoid arthritis (RA) and inhibition of radiographic~     progression in patients with active RA who are unresponsive to treatment with~     disease-modifying antirheumatic drugs (DMARD).~   "
149903|NCT01604330|"~     The main objective of this study is to show the effectiveness to a year of baclofen compared~     to placebo, on the proportion of patients with a low risk alcohol consumption or no,~     according to the WHO standards.~   "
149904|NCT01604317|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low~     birth weight infant with or without plastic head cover used during resuscitation.~   "
149905|NCT01604304|"~     Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave~     lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature,~     the two procedures are available to treat these stones with a good stone free rate. There is~     no prospective randomized study comparing these two treatments. Our study will define with a~     good level of evidence which technique is the best with regard to the stone free rate,~     secondary procedure rate and adverse effect.~   "
149906|NCT01604291|"~     This multi-center, observational study will evaluate the efficacy and safety of dual and~     triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis~     C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin~     plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to~     24 weeks of follow-up.~   "
149907|NCT01604278|"~     This study assessed the efficacy, safety and tolerability of the co-administration of NVA237~     plus indacaterol taken once daily versus indacaterol taken once daily in patients with~     moderate to severe Chronic Obstructive Pulmonary Disease.~   "
149908|NCT01604265|"~     To investigate the ability of Sativex to relieve central neuropathic pain in multiple~     sclerosis subjects.~   "
149909|NCT01604252|"~     This multi-center, prospective, observational cohort study will evaluate the effectiveness,~     safety and utilization of treatments in patients with advanced basal cell carcinoma and basal~     cell carcinoma nevus syndrome. The total study duration is anticipated to be a maximum of 8~     years, including 3 years for patient recruitment and 5 years follow-up.~   "
149910|NCT01604239|"~     This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events~     than celecoxib in subjects with osteoarthritis.~   "
149911|NCT01604226|"~     The BIS is influenced by multiple parameters, such as age,gender, body weight, height, muscle~     relaxants, hepatic function, co-administered drugs, surgical stimulation, but is thought to~     be influenced mainly by propofol and remifentanil infusion dose. As such, the investigators~     postulate that the BIS value could be predicted by the estimated effects-site concentration~     of propofol and remifentanil, and try to establish a multiple linear regression model for~     predicting BIS value.~   "
149912|NCT01604213|"~     The purpose of this study is to demonstrate that combined vildagliptin-metformin therapy is~     associated with clinically significant reductions in biological markers of inflammation,~     pro-thrombogenicity, and atherosclerosis as compared to metformin mono-therapy in a~     population of diabetic patients with coronary artery disease who undergo cardiac~     rehabilitation.~      The pre-specified established biological markers of inflammation, pro-thrombogenicity, and~     atherosclerosis will include: interleukin-6 (IL-6 - primary biological marker), hs-CRP,~     platelet reactivity testing, MMP-9, Interleukin 1 beta (IL-1 beta) and adiponectin levels.~   "
149913|NCT01604200|"~     20% of Canadians are hypertensive with approximately 200,000 new cases each year. Early~     detection of hypertension affects outcomes, reducing the risk for heart attack, stroke,~     kidney disease, and dementia. Screening strategies are required to identify the more than one~     third of Canadians with unrolled high blood pressure, in particular, younger men unaware of~     their condition, women over sixty years old, and underserved groups.~      A collaborative practice model linking dentists to other healthcare providers in a reporting~     network is a promising model for hypertension detection and management. There are 20,129~     licensed dentists in Canada who graduate with the ability to measure blood pressure, and 74%~     of the population visits a dentist each year. This represents an opportunity, but information~     is required on Dental attitudes toward screening for hypertension before attempting to~     initiate a screening model. To engage dentists in hypertension detection requires an~     understanding of the practice environment and the factors that shape their beliefs, attitudes~     and behaviours regarding routine hypertension screening in their practices.~   "
149935|NCT01603914|"~     The aim of this project is to answer the following questions:~      To determine the incidence of catheter related bacteremia (CRB) with three strategies of~     central venous catheter exchange in critically ill adult patients with major burn and to~     determine the regimen that will minimize the risk of bacteremia.~      To determine the incidence rate of catheter colonization in adult patients with major burns.~      The scientific knowledge to be acquired through this project is of likely benefit to the care~     of critically ill patients with burns injury as follows:~      The intention is to improve the outcomes in critically ill patients by minimizing one of the~     most frequent causes of infection in the Burn Intensive Care Unit, those from central venous~     catheters. Decreasing infections will decrease morbidity, decrease length of stay, decrease~     costs, and decrease mortality.~   "
149914|NCT01604187|"~     Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the~     patient. The pain associated with the procedure is not caused by the insertion of the scope~     but from inflating of the colon in order to do the inspection. It has been shown that~     colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients~     feel discomfort during the procedure. Factors predicting a painful colonoscopy are~     female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy~     (Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are~     associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or analgesia~     are achieved by administering a benzodiazepine or a combination of a benzodiazepine and an~     opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine (Dere et al. 2009) or by~     using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol as monotherapy did not~     significantly decrease pain intensity or endoscopist's evaluation of colonoscopy (Grossi et~     al. 2004). Currently, intravenous midazolam is the drug used most commonly to introduce some~     sedation for colonoscopy. Intravenous sedation definitely increases the cost of procedure;~     drug administration, need for pulse oximetry monitoring and the need for follow-up after the~     procedure make colonoscopy sometimes expensive and troublesome. It has also been shown, that~     low-dose midazolam neither relieves discomfort nor makes patients forget it (Elphick et al.~     2009).~      Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal~     sublingual formulation of fentanyl has been developed to further improve the management of~     pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed~     under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by~     the body through the mucous membrane. After administration of buccal fentanyl maximum plasma~     drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl~     concentrations versus time following buccal and sublingual administration are very similar~     (Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the~     tongue at the deepest part. Sublingual administration is an easy and non-invasive method of~     pain treatment for the patient coming to colonoscopy done as an office based procedure. Other~     advantages compared to invasive methods are improved comfort of patients and no need for~     intravenous access because of pain relief. Before, it has been used in the management of~     breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and~     well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use~     of transmucosal tablet for colonoscopy patients is a quite new approach.~   "
149915|NCT01604174|"~     The purpose of this clinical trial is to compare the effectiveness of a new interactive~     virtual telerehabilitation (IVT) system with the conventional program in the rehabilitation~     of patients after total knee arthroplasty.~   "
149916|NCT01604161|"~     This study is conducted in Japan. The aim of this study is to collect information about the~     efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature~     with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature~     with Turner Syndrome where epiphysial discs are not closed.~   "
149917|NCT01604148|"~     Persistent detrusor overactivity (DO) after transurethral prostatectomy results in~     symptomatic failure in more than one third of the patients. Storage symptoms are major~     complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate~     (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction~     (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in~     conjunction with the prescription of the anticholinergic drugs.~   "
149918|NCT01604135|"~     The purpose of this study is to determine whether corneal collagen crosslinking is effective~     in the treatment of progressive keratoconus.~   "
149919|NCT01604122|"~     This study is an online (web-based) or paper-based survey for patients with transthyretin~     familial amyloidosis polyneuropathy (TTR-FAP) and caregivers. The results will be used to~     describe the emotional, physical, and financial impact of having TTR-FAP or caring for~     someone who has the disease.~   "
149920|NCT01604109|"~     The purpose of this study is to determine if adding daily application of CPP-ACP containing~     paste for one year is superior to regular fluoride tooth brushing in preventing dental caries~     in high caries risk Thai preschool children.~   "
149921|NCT01604096|"~     Use of information campaigns and educational interventions directed to citizens and supported~     by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by~     several studies with conflicting results. These interventions are potentially relevant,~     favouring the reduction of unnecessary use of medicines and related risks. Several studies~     have specifically evaluated the promotion of the appropriate use of antibiotics in adults and~     children, with variable results. A controlled study has been proposed to evaluate the~     feasibility and effectiveness of a multifaceted intervention aimed at reducing antibiotic~     prescription by increasing awareness on risks of their unnecessary use.~      Information has been provided to citizens through several media (posters, local TV, radio and~     newspapers, video terminals, websites of Local Health Authorities). Brochures with~     information on expected benefits and risks of antibiotics has also been available, either~     with direct access in waiting rooms and pharmacies or handed out and mediated by doctors.~     Physicians and pharmacists received specific data on local antibiotic resistance. A small~     group of representative doctors have also actively participated in defining the campaign key~     messages. A sample of general practitioners and paediatricians have been trained in patient~     counselling strategies.~      The information campaign has been implemented in two Provinces of Emilia-Romagna during the~     fall-winter season (November 2011-February 2012). Change in the overall prescribing rate of~     antibiotics (expressed as DDD per 1000 inhabitants/day) in the intervention area will be~     compared versus other areas in the same Region. Knowledge and attitudes of the general~     population will be evaluated through a phone and internet survey on a representative sample.~      This study could observe a reduction lower than 5% in the prescribing rate of antibiotics.~   "
149922|NCT01604083|"~     The aim of the ETPOS study is to describe differences in transfusion habits throughout Europe~     and to correlate these habits to perioperative outcome parameters. Special focus is put on~     the number of PRBCs (packed red blood cells) transfused and the ratio of PRBCs to other blood~     products or coagulation factors in the operating room. Furthermore the motivation of~     physicians to transfuse PRBC and blood products in the operating room will be investigated.~   "
149923|NCT01604070|"~     Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises~     flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with hyperextension~     of the metatarsophalangeal (MTP).~      Etiologies of hammertoe deformity include a foot in which the second ray is longer than the~     first, MTP synovitis and instability, inflammatory arthropathies, neuromuscular conditions,~     and ill-fitting shoe wear. When a foot's second ray is longer than the first and shoe wear~     does not fit correctly, flexion of the PIP joint occurs to accommodate the shoe. This length~     difference also causes MTP synovitis to develop from overuse of the second MTP joint.~     Attenuation of the collateral ligaments and plantar plate result, and the MTP joint~     hyperextends and may even progress to dorsal subluxation or dislocation (see image below).~     Rheumatoid arthritis causes hammertoe deformity by progressive MTP joint destruction, leading~     to MTP joint subluxation and dislocation.~      With all 3 of these etiologies, the extensor digitorum longus (EDL) tendon gradually loses~     mechanical advantage at the PIP joint, as does the flexor digitorum longus (FDL) tendon at~     the MTP joint. The intrinsic muscles fire and sublux dorsally, as the MTP hyperextends. They~     now extend the MTP joint and flex the PIP joint, as opposed to their usual functions of~     flexing the MTP joint and extending the PIP joint.~   "
149924|NCT01604057|"~     This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a~     biomarker of bone formation in postmenopausal women with low bone mass.~   "
149925|NCT01604044|"~     This study evaluates the effects of different therapies in ovulation induction in~     Intrauterine Insemination Cycles.~   "
149926|NCT01604031|"~     This is a research study to determine the safety and effectiveness of using special cells~     that may make the subject's immune system fight their chronic lymphocytic leukemia (CLL) in~     combination with a drug called Lenalidomide.~      To do this, the investigators will put a special gene into cancer cells that have been taken~     from the subject. This will be done in the laboratory. This gene will make the cells produce~     interleukin 2 (IL-2), which is a natural substance that may help the subject's immune system~     kill cancer cells. Additionally, the investigators will stimulate the cancer cells with~     normal embryonic fibroblasts (cells that develop into normal connective tissues in the body)~     so that they will make another natural protein called CD40 ligand (CD40L). Some of these~     cells will then be put back into the subject's body with the goal that they will act like a~     vaccine and stimulate the immune system to attack the CLL cells.~      The investigators have already conducted a study similar to this in other subjects with CLL.~     In those subjects the investigators saw some changes in the subject's immune system that~     might indicate that the modified cells were helping their immune system fight the cancer.~     However, in most of the subjects this change in the immune system went away after the~     injections were stopped. The investigators think that this may be due to a high level of~     cells called T regulatory cells. T regulatory cells are part of the immune system and prevent~     excessive reactions from other cells in the body. Studies have shown that reducing T~     regulatory cells allows the body to fight the cancer for a longer period of time.~      Recent studies have shown that using Lenalidomide helps the body reduce T regulatory cells.~     Using Lenalidomide along with the injections (shots) might help the body fight the cancer for~     a longer period of time. Lenalidomide is also called Revlimid.~      In this study the investigators want to see if they can make the change in the immune system~     last longer by giving Lenalidomide before and at the same time as the vaccine. The~     investigators hope that this might produce a better response directed at the CLL cells.~     Subjects will receive injections for about a year~   "
149927|NCT01604018|"~     Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic~     rhinoconjunctivitis and/or asthma.~      The purpose of this optional observational follow-on study is to further evaluate~     rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who~     completed all dosing visits in study CP005 and all visits in study CP005A approximately two~     years after the start of treatment.~   "
149928|NCT01604005|"~     The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT~     radiotherapy is effective in preventing or delaying the onset of chest nodules in patients~     with Mesothelioma.~   "
149929|NCT01603992|"~     Background:~      - Marijuana is the most widely used illicit drug in the world, yet relatively little is known~     about users who try to quit without formal treatment ( spontaneous quitting). Studies have~     suggested that there are some common strategies that many individuals use in spontaneous~     quitting, such as changing one s lifestyle or identity, reminding oneself of negative~     consequences, support from family and friends, and religion. However, more research is needed~     to determine potential treatment strategies for marijuana use.~      Objectives:~        -  To identify strategies used to help with marijuana quitting among non-treatment seeking~          adult marijuana users.~        -  To identify withdrawal symptoms experienced during marijuana quitting and their~          relationship to the quitting strategies used and the outcome of the quit attempt.~        -  To evaluate whether subgroups of marijuana users differ in their experience of marijuana~          quitting.~      Eligibility:~      - Individuals at least 18 years of age who have made at least one attempt to quit marijuana~     use.~      Design:~        -  The study will consist of one visit of approximately 1 to 2 hours.~        -  Participants will fill out three questionnaires. The questionnaires have different types~          of questions, and will ask about background and lifestyle, marijuana use and craving~          patterns and behaviors, and difficulties in previous attempts to quit using marijuana.~   "
149930|NCT01603979|"~     This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate~     the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD)~     and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and~     preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once~     every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid~     tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated~     in an expansion cohort at the RP2D for safety and anti-tumor activity.~   "
149931|NCT01603966|"~     This study is to determine whether the AggreGuide platelet aggregometer can discern the~     effect of low dose aspirin on subjects platelet aggregation using arachidonic acid as the~     agonist.~   "
149932|NCT01603953|"~     Protein-energy malnutrition and muscle wasting are a common finding among patients with liver~     cirrhosis. Its prevalence may range from 50-90% depending on the methods used for nutritional~     assessment. Even stable cirrhotic patients referred as Child A have muscle depletion and the~     majority of patients classified as Child C have significant depletion. Malnutrition has been~     shown to be related to several complications of cirrhosis~      Despite the importance of nutritional status in patient's outcome, there is no gold standard~     for nutritional assessment. Traditional techniques used in healthy subjects to assess~     nutritional status cannot be used in cirrhotic patients due especially to ascites and~     peripheral edema, and altered rates of biochemical markers due to liver failure.~      Bioelectrical impedance vector analysis has emerged as a useful method to assess body~     composition and nutritional status especially in patients at the extremes of body weight~     (fluid overload, excess of adipose tissue, etc.).~      The aim of this study is to evaluate whether malnutrition assessed by bioelectrical impedance~     vector analysis is related to the development of hepatic encephalopathy~   "
149933|NCT01603940|"~     The purpose of this study is to compare losartan and benazepril in diabetic patients whose~     high blood pressure is not controlled by amlodipine and its relationship to statin current~     use.~   "
149934|NCT01603927|"~     Bowel cancer is a common disorder in the UK. Most cancers happen when a type of polyp, called~     an adenoma, becomes cancerous. Polyps are growths in the large bowel that can be cancerous,~     non-cancerous, or pre-cancerous (adenoma). Polyps are most commonly detected during~     colonoscopy (camera test of the lower bowel). The removal of adenomas has been shown to~     reduce the subsequent risk of bowel cancer. Current practice is that all polyps are removed~     or biopsied to allow a laboratory diagnosis (histology). This is important as it influences~     if and when patients require follow-up colonoscopies, known as the surveillance interval.~     Patients with only non-cancerous polyps do not need surveillance.~      A new blue light technology, called narrow band imaging (NBI), used during colonoscopy can~     help colonoscopists (doctor or nurse performing the procedure)differentiate between polyp~     types during colonoscopy. NBI is currently available in a large number of UK endoscopy units~     however is variably used. Studies from 'expert' centres have demonstrated that NBI allows~     accurate optical diagnosis of colonic polyps. Benefits of optical diagnosis include avoiding~     removal of non-cancerous polyps and an immediate (on the day) diagnosis for the patient~     including the surveillance interval.~      The primary aim of this study is to evaluate the accuracy with which colonoscopists assess~     the required surveillance interval using optical diagnosis when compared with histology in~     non-expert centres. The investigators will invite 2500 patients, who have been referred for~     colonoscopy, to participate. Patients will undergo a routine colonoscopy the only addition~     being the use of NBI during the procedure. Colonoscopists will provide an optical diagnosis~     at the time of colonoscopy in addition to polyp removal or biopsy.~      The investigators will compare surveillance intervals provided using optical diagnosis with~     the diagnosis from histology and thereby the accuracy with which colonoscopists can use the~     technology. The investigators will also calculate the cost savings to the NHS.~   "
149936|NCT01603901|"~     Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard~     technology for treatment of various chronic and acute wounds. The investigators plan to~     evaluate the efficacy and ease of use of this device.~   "
149937|NCT01603888|"~     B-type natriuretic Peptide (BNP) is a cardiac hormone secreted from the cardiac myocytes in~     response to volume load. Plasma levels of BNP, as measured by immunoassay methods, are~     elevated in patients with heart diseases. However, the biological effects of BNP are blunted~     in heart failure and other cardiac conditions. Moreover, the peptide levels are also elevated~     in non cardiac conditions such as the neonatal period, sepsis and renal failure. Recent~     investigations suggest alteration of the peptide molecular structure in heart failure. These~     alterations may explain, at least partially, the reduced biological activities of BNP in~     heart failure.~      Immunoreactive BNP and NT-proBNP have been identified in human urine. It has been suggested~     that urinary BNP correlates with plasma BNP, and may serve as a non-invasive measure for this~     cardiac marker. It is unclear what BNP fractions are cleared in the urine in health and~     disease.~      The aim of the proposed studies is to elucidate precisely the molecular form of BNP in~     various disease and specific physiological states in plasma and urine of infants and~     children.~   "
149938|NCT01603875|"~     Pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies~     Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.~      After the pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell~     Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 42 are 0.5~     IU/ml or more.~      And Simulated post-exposure rabies booster vaccination with a new Chromatographically~     Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies~     vaccine.~      After the simulated post-exposure rabies booster vaccination with a new Chromatographically~     Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients~     on day 14 after the booster are 0.5 IU/ml or more.~   "
149939|NCT01603862|"~     Dementia is serious problem and around 700 000 people are affected in the UK alone. Currently~     there is no cure however early diagnosis and effective treatment offers hope for reducing the~     impact. Dementia sufferers require care due to physical disability, cognitive deficits,~     social isolation and emotional symptoms (depression). Delaying the onset of dementia will~     improve quality of life for patients and reduce the cost of residential care (£42 000 per~     person per year).~      People with mild cognitive impairment (MCI) are at high risk of developing dementia. They~     have impaired cognitive abilities, such as memory, but still manage their everyday~     activities. Studies show that 8 out of 10 people with MCI will have developed dementia 6~     years after diagnosis.~      Regular physical activities and performing a variety of cognitive activities reduce the risk~     of dementia and improves abilities and quality of life in healthy people. Therefore a~     combination of these activities may reduce the risk of developing dementia in MCI. The~     investigators want to see if they can develop a program which combines these activities in a~     fun and social way that gets people active and keeps them active. The aims are to improve~     fitness, cognition and quality of life. The investigators plan to use computers and the~     internet to help with the activities and to make them available to people who are isolated.~     Physical activity will involve walking from home, cognitive activities will be computer based~     games and puzzles and socialising will involve regular varied group-based activities.~     Participants (128) will be recruited from the UCL Derwent Memory Clinic and will complete a~     26 week program. They will then be followed up yearly to monitor their progress. The main~     outcome of the study is engagement in the activities. The investigators will also measure~     fitness, cognition, quality of life and conversion to dementia.~   "
149940|NCT01603849|"~     Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer~     (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally~     advanced or metastatic disease. Important to mention the number of patients that progress or~     recur in central nervous system (CNS). It has been reported that patients with~     adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (CEA) are~     in the highest risk to develop brain metastasis. In small cell lung cancer, treatment with~     prophylactic cranial irradiation (PCI) is the standard of care in patients without~     progression after locoregional or systemic treatment because the proven benefit in overall~     survival (OS) and progression free survival (PFS). However, in NSCLC PCI has not been able to~     prove any survival benefit, only in CNS PFS, probably because there is no trial, to our~     knowledge, of PCI in NSCLC that include only the specific group of patients considered in~     high risk of developing brain metastasis.~   "
149941|NCT01603836|"~     The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with~     allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing.~     Allograft by itself is not an effective material as a posterior onlay graft for the PLF in~     adult surgery.~   "
149942|NCT01603784|"~     The purpose of this randomized, controlled, prospective study is to evaluate the benefits of~     combining aerobic exercise with cognitive training for optimizing cognitive function. The~     study will enroll 109 men and women, age 55-75 years who are in stable health and without~     contraindications to exercise or evidence of dementia or cognitive impairment. Individuals~     will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health~     Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training, and~     Home Exercise and Health Education. Participants will undergo measurements of cognitive~     function, physical performance, and complete questionaires about daily activities, physical~     activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after~     baseline.~   "
149943|NCT01603771|"~     The goal of this pilot study is to evaluate whether healthy, sedentary older adults have~     increased activation of specific brain areas, in response to exercise and cognitive training,~     in comparison to a control group, and whether improvements in psychometric test performance~     are related to increased activation of brain networks. Participants, between age 55-75 years~     will be recruited from an ongoing study of exercise and cognitive training, to undergo Blood~     Oxygen Level Dependent (BOLD) functional magnetic imaging (fcMRI).~   "
149944|NCT01603758|"~     The underlying hypothesis is that whole body cholesterol - including cholesterol present in~     tissues that cannot be measured by standard blood tests - is related to heart disease risk.~     Endogenous cholesterol will be labeled with an intravenous infusion of one type of~     cholesterol tracer and dietary cholesterol will be labeled with another. These tracers will~     be used to measure how fast cholesterol is synthesized and excreted using mass spectrometry~     to distinguish the tracers. Data will be related to circulating biomarkers (blood tests) and~     to the thickness of the lining of the carotid artery. The effect of the drug ezetimibe on~     these processes will also be determined. Successful completion of this study will give us~     more knowledge about cholesterol metabolism that may be useful in designing new drugs and~     treatments for patients with heart disease, especially those that are already receiving~     maximum amounts of current medications.~   "
149945|NCT01603732|"~     The goal of this study is to find out if there is any association between a mother's exposure~     to bacteria that normally causes strep throat and her baby's developing heart disease/heart~     defect.~   "
149946|NCT01603719|"~     The purpose of this clinical trial is to evaluate the effect of a new infant starter formula~     with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.~   "
149947|NCT01603563|"~     The aim of this R34 study is to develop and test the feasibility of a Stepped Care~     intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will focus~     on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive Behavioral~     Therapy (SC-TF-CBT) in a small open trial (N=10). Phase II will consist of a randomized~     controlled trial (N=54) examining the efficacy of SC-TF-CBT relative to standard~     Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)on a number of outcome measures,~     treatment acceptability and satisfaction, and costs of treatment delivery. Findings from this~     pilot study will establish the feasibility and preliminary efficacy (see Kraemer et al.,~     2006) of SC-TF-CBT before progressing to a larger, randomized R01 to examine the~     effectiveness of SC-TF-CBT for early childhood PTSD.~   "
149948|NCT01603550|"~     This proposed laboratory study will extend previous findings on relationships between~     cognitive function and nutritional status to conditions that more closely resemble military~     operations where aerobic exercise, inadequate nutritional intake and sleep deprivation~     combine to degrade cognitive function. The investigators will examine cognitive function,~     brain activity and glucose levels in volunteers who are calorie-deprived, performing high~     workload cognitive tests, exercising and, in one arm of the study, are sleep-deprived for~     approximately 48 hours. A comprehensive cognitive test battery will be repeatedly~     administered and several cognitive tests will be administered when volunteers are exercising.~     Interstitial glucose levels will be assessed and whole body nitrogen utilization determined.~     The effects of energy restriction and the physiological basis of the relationship between~     peripheral glucose levels and cognitive function will be examined using a state-of-the-art~     imaging technology, functional Magnetic Resonance Imaging (fMRI). This technique will allow~     any key brain regions affected by caloric deprivation to be identified.~   "
149949|NCT01603537|"~     Trauma is the leading cause of death among persons below 60 years of age. It is a~     well-established belief that optimal treatment in the early phase after trauma has a major~     impact on mortality, and the implementation of specific educational programs for trauma care~     have been a widely adopted strategy aimed at improving the outcome. This strategy has high~     face validity, but the underlying evidence is poor. The Prehospital Trauma Life Support~     (PHTLS) program was introduced in 1983 aiming to integrate prehospital trauma care with the~     Advanced Trauma Life Support (ATLS) program. Approximately half a million prehospital~     caregivers in over 50 countries have taken the PHTLS course. It has been recognized as one of~     the leading educational programs for prehospital emergency trauma care. However, the~     scientific support for improved patient outcome from courses such as PHTLS and ATLS is~     limited. According to a Cochrane analysis published 2010 there is no evidence to recommend~     advanced life-support (ALS) training for ambulance crews. Another Cochrane analysis~     concerning ATLS gave similar results and a recent study indicated even worsened outcome after~     the implementation of ATLS. An observational study in the county of Uppsala indicated reduced~     mortality after the implementation of PHTLS but the estimate was uncertain due to a low~     overall mortality. The aim of this study is to further investigate the association between~     PHTLS training of ambulance crew members and the outcome in trauma patients in a larger study~     population. To accomplish this the investigators will use an epidemiological semi-individual~     design applied to all victims of traffic injury that occurred during the implementation~     period of the PHTLS course in Sweden (1998-2004). Four outcomes and subsets of patients will~     be analyzed: Mortality before hospital admission, mortality within 30 days, time to death~     among survivors to hospital admission and return to work among survivors to hospital~     discharge.~   "
149950|NCT01603524|"~     This proposal outlines the design of a cluster randomized controlled trial to compare the~     effectiveness of a new approach to integrating smoking cessation services into routine~     interactions with patients in the primary care setting using an adaptation of the Ottawa~     Model for Smoking Cessation (OMSC). The OMSC aims to systematically identify the smoking~     status of all patients, provide brief cessation advice, and offer evidence-based cessation~     support to those interested in embarking on a quit attempt. This study will provide important~     new evidence to assist with the development of a more comprehensive cessation system in the~     province of Ontario and across Canada.~   "
149951|NCT01603511|"~     The study will compare the rewarming effectiveness of heat donation through the head or the~     torso during rewarming of mildly hypothermic subjects. Warming will be accomplished through~     either forced-air warming or using a charcoal heater; both units are commonly used for~     warming. The investigators hypothesize that head warming will be as, or more, effective~     compared to~   "
149952|NCT01603498|"~     The main aim of the present study was to investigate the effect of preemptive dexamethasone~     and methylprednisolone to prevent pain, swelling and limitation in mouth opening following~     third molar extraction.~   "
149953|NCT01603407|"~     The Finding the Optimum Regimen for Duchenne Muscular Dystrophy (FOR DMD) study will compare~     three ways of giving corticosteroids to boys with Duchenne muscular dystrophy (DMD) to~     determine which of the three ways increases muscle strength the most, and which causes the~     fewest side effects. Using the results of this study, the investigators aim to provide~     patients and families with clearer information about the best way to take these drugs.~   "
149954|NCT01603823|"~     The purpose of this study is to investigate the morphological and angiological retinal~     changes in different macular diseases.~   "
149955|NCT01603810|"~     Optical coherence tomography (OCT) is an imaging technique which shows the internal structure~     of living tissue (in vivo). It is safe, quick and painless to perform, and does not damage~     the tissue in any way. Recent advances in the technology mean that it can now be used to take~     images of the internal structure of the skin. This is useful because certain conditions, such~     as skin cancers, alter this structure. At present a suspected skin cancer is identified by~     taking a sample (a biopsy) which is analysed under the microscope to confirm the diagnosis.~     The cancer is then excised including a margin of apparently healthy-looking skin around it to~     ensure that the entirety of the tumour is removed. The excised tumour is then analysed again~     under a microscope to confirm that it was indeed completely removed (histology), after which~     a further operation is required to repair the defect.~      The purpose of this study is to evaluate OCT imaging of a particular type of skin cancer~     called a basal cell carcinoma (BCC), and in particular BCCs affecting the skin around the~     eyes (periocular). The study will compare the ability of OCT to define the margin of the BCC~     with the current 'gold standard' of histology. OCT could potentially improve the~     investigators ability to define the margins of the tumour before surgery and become a guide~     for minimally invasive surgery. The preservation of healthy tissue represents a priority,~     particularly in the area of the skin surrounding the eye.~   "
149956|NCT01603797|"~     The aim of this study was to investigate if guided internet-delivered acceptance and~     commitment therapy (ACT)would help chronic pain patients.~   "
150806|NCT01592552|"~     The purpose of this research project is to collect and store blood samples and clinical data.~     Researchers can then use the stored samples in future studies. Through such studies, they~     hope to find new ways to detect, treat, and maybe even prevent or cure health problems.~   "
149957|NCT01603745|"~     Polycystic ovary syndrome (PCOS) is often associated with pathological conditions, such as~     insulin resistance (IR), type 2 diabetes (DM2), obesity and it has potentially increased risk~     for cardiovascular disease (CVD). Of note, risk factors for CVD including dyslipidaemia,~     hypertension, oxidative stress and inflammation are associated with PCOS. The investigators~     want to evaluate the effects of two different types of E/P therapy on cardiovascular risk in~     PCOS.~   "
149958|NCT01603706|"~     The purpose of this study is to evaluate the use of radial strain imaging using speckle~     tracking analysis to predict the response to CRT in patients with ischemic cardiomyopathy~     (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT~     indication. Thus assessing the value of lead localization determined by radial strain imaging~     in a prospective, randomized manner.~   "
149959|NCT01603693|"~     Amongst the consequences of missing teeth are change of appearance and difficulties in~     mastication and speech. Dental implants in the maxilla or mandible provide a common treatment~     modality by offering anchorage to fixed or removable fixtures. In many cases, the lack of~     teeth is accompanied by lack of appropriate bone volume in the desired area for dental~     implant placement. Possible causes for this lack of sufficient bone volume are varied and~     include earlier bone atrophy, traumatic tooth extraction and bone resorption due to~     periodontal disease. In such cases, dental implant placement is preceded by alveolar bone~     augmentation . Guided Bone Regeneration (GBR) is a common bone augmentation technique in~     which a bulk of bone substitute is placed in the area which needs more volume before placing~     a dental implant. The bone substitute is covered with an inert membrane and may provide a~     scaffold and encourage cells from the patient to reach the area and build new bone volume. A~     common bone substitute in use for that matter is Deproteinized bovine bone mineral (DBBM)~     which resembles human bone and helps encourage new bone formation. On the contrary its~     structural stability during placement and early healing is low. Bi-Phasic Calcium-Sulphate is~     another common bone substitute with easy handling properties and good structural stability~     during early healing. Its replacement by natural bone contributes to the augmentation~     process. Although DBBM efficacy in GBR process has been investigated, using DBBM in~     combination with bi-phasic calcium-sulphate as a binding material during GBR was not~     examined. This prospective study will examine augmented bone quality and quantity following a~     GBR procedure with common approved bone substitutes: DBBM (Bio-Oss, Geistlich) alone or in a~     combination with bi-phasic Calcium-sulphate (BondBone, Augma). The GBR procedures will~     precede dental implant placement as custom. The quality and quantity of the new formed bone~     will be assessed by a C.T (computerized tomography) which is done routinely before dental~     implant placement and by further analyses of bone residues which will follow drilling the~     dental implant placement site while preparing it (as common).~   "
149960|NCT01603680|"~     1. Evaluation of the efficacy of the circumferential versus non circumferential~          distribution of mepivacaine around the median and ulnar nerves.~        2. Evaluation the onset of action of mepivacaine in circumferential versus non~          circumferential distribution around the median and ulnar nerves.~        3. Spread of mepivacaine after injection guided by ultrasonography.~        4. Complications of both anesthetic techniques in postoperative time.~   "
149961|NCT01603667|"~     The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg~     versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an~     acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90.~      The secondary objectives are as follows:~        -  To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel~          Index (BI) score at Day 90.~        -  To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent~          stroke, cardiovascular events and death of all causes.~        -  To evaluate the safety of PG2 Injection 500 mg treatment~   "
149962|NCT01603654|"~     Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon~     preparation affects the quality of colon cleansing. The study is aimed at comparing the~     efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and~     low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor~     bowel preparation.~   "
149963|NCT01603641|"~     This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the~     treatment of pediatric lower limb spasticity.~   "
149964|NCT01603628|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in~     pediatric patients with lower limb spasticity.~   "
149965|NCT01603615|"~     This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the~     treatment of pediatric upper limb spasticity.~   "
149966|NCT01603602|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in~     pediatric patients with upper limb spasticity.~   "
149967|NCT01603589|"~     The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC)~     extracorporeal circulation on perfusion characteristics and remote end-organ protection~     (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting~     (CABG).~   "
149968|NCT01603576|"~     This study will be an initial proof of concept study, to evaluate safety and efficacy of a~     prototype suprachoroidal retinal implant~   "
149969|NCT01603485|"~     The purpose of this study is to estimate the pharmacokinetics (PK) of 3 different~     modified-release formulations of lersivirine and compare it to the PK of the~     immediate-release tablet. The effect of food on the PK of one of the modified-release tablets~     will also be assess along with the safety and tolerability of each treatment.~   "
149970|NCT01603472|"~     Parenteral nutrition (PN) is the provision of nutrients via the intravenous route. Parenteral~     nutrition associated metabolic bone disease (MBD) was first described in children in the~     1980s. Since then, there has been little to no research into the underlying relationship and~     as a result, little evidence on which to base clinical care. In adults, MBD is associated~     with increased fractures. At the Hospital for Sick children in Toronto, an intestinal failure~     program has been set up since 2003. This is the only intestinal failure program in Canada and~     receives country wide referrals. Most of the patients have short bowel syndrome (SBS) and~     require PN for prolonged periods, or for life. About 90% of these patients have MBD, and some~     have had bone fractures. An understanding of the etiology of MBD would provide information to~     guide care, and prevent this condition. Funding for this area of research however is~     challenging because intestinal failure requiring long term PN is a rare condition, accounting~     for approximately 200 - 300 children in all of Canada. The goal of this study therefore is to~     gather pilot data on markers of MBD in children on long term PN, and to compare these markers~     to age and gender matched control patients who are fed by mouth or feeding tube. The~     information gathered from this study will help us begin to understand what is actually~     happening in the bones of children on long term PN and will form the basis for future studies~     and improved clinical care.~   "
149971|NCT01603459|"~     The purpose of this study is to determine whether injections with increasing doses (up to 800~     units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in~     treating patients with spasticity on one body side due to cerebral causes.~   "
149972|NCT01603446|"~     MELAS patients suffer from exercise intolerance, weakness, poor vision or blindness, poor~     growth, developmental delay, and deafness. They also have unique 'stroke-like' episodes~     (SLEs) which are not due to blockages of large or medium arteries. These 'strokes' are~     thought to be due to energy failure of very small brain blood vessels combined with energy~     failure in the mitochondria (cell battery) of the brain cells, especially in the back region~     of the brain in the vision centre. This leads to visual loss and paralysis. The overall goal~     of this study is to better understand the mechanism of these SLEs at the level of the brain~     cells and small blood vessels.~   "
149973|NCT01603433|"~     This is a single center, prospective, non-randomized, feasibility study for the evaluation of~     safety, efficacy and performance of the Sapheon™ Closure System for the treatment of~     incompetent saphenous veins.~   "
149974|NCT01603420|"~     The purpose of this study is to compare the effects on prostate cancer using radiation~     therapy with or without chemotherapy.~   "
149975|NCT01603394|"~     The primary objective is to explore whether sensory symptom cluster analysis is useful for~     predicting treatment response in Postherpetic Neuralgia.~   "
149976|NCT01603381|"~     The investigators intend to assess the following:~        -  the efficacy of CBTi in treating insomnia during recovery,~        -  does a family history of alcoholism moderate the insomnia symptoms,~        -  does an improvement in insomnia lead to a decrease in impulsivity.~   "
149977|NCT01603368|"~     Mortality and incidence of severe complications is still high among extremely premature~     infants. Common causes of severe complications in this population are poor nutrition,~     necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common~     problem resulting in prolonged need for intravenous lines and poor nutrition.~      The aim of the study is to evaluate whether supplementation with the probiotic bacterium~     Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight~     increases feeding tolerance to breast milk and thereby improves nutrition, increases growth~     and reduces serious complications and mortality in this population. Beyond this, possible~     mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.~   "
149978|NCT01603355|"~     The investigators are doing this research study to see if tocilizumab (Actemra) is safe and~     effective when used for severe or refractory non-infectious uveitis. Uveitis is an~     inflammation of the eye that is caused by the body's immune system reacting against the eye~     tissues.~   "
149979|NCT01603342|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     determine the feasibility of demonstrating a quantifiable change from baseline in punch~     biopsy-induced bleeding durations and blood loss volumes in healthy subjects after receiving~     clopidogrel anti-platelet therapy.~   "
149980|NCT01603329|"~     The goal of this project is to increase patient adherence to medication using communications~     and incentives for physicians. The investigators are partnering with a health insurance~     company, Humana Inc, to design and implement an incentives program for physicians whose~     patients increase their medication adherence for oral diabetes medication, hypertension (ACEI~     or ARB) medication, and/or cholesterol (statins) medication. The investigators will use~     behavioral economics to explore the best way to communicate the incentives to the physicians.~   "
149981|NCT01603316|"~     The investigators have found that many patients getting treatment for cancer have trouble~     getting enough to eat, or do not always have enough money for food. When a patient has these~     problems it can lead to difficulties with completing cancer treatment. Across New York City,~     there are many hospitals that offer their patients food pantry services on location. The~     investigators would like to compare how food pantries within the hospital and two other food~     assistance options: monthly food vouchers and weekly grocery deliveries maybe possible~     solutions to this problem. The patient will be randomly assigned to one of the three~     different food program groups, which means everyone has an equal chance in being in any~     group, like a flip of a coin. The investigators hope to learn how to best help patients with~     trouble getting food and to see if this will help with completing cancer treatment.~   "
149982|NCT01603303|"~     Aromatase inhibitors (AIs) are used to try to stop breast cancer from forming or returning~     after treatment in women who are in menopause and who had breast cancer that was sensitive to~     the hormone estrogen.~      The goal of this study is to learn if it is possible to prevent some AI side effects,~     particularly problems with vaginal dryness and pain during sexual activity. Researchers also~     want to compare 2 new vaginal moisturizers to see if using them regularly helps women avoid~     vaginal dryness. Researchers want to see if preventing these side effects will decrease the~     number of women who stop taking AIs due to the side effects they cause.~   "
149983|NCT01603290|"~     The purposes of this study are to (1) explore the severity of symptom of leukemia patients~     experienced before and after chemotherapy in hospital, (2) investigate the trajectories of~     the fatigue and physical fitness, and their related factors, and (3) the correlation between~     fatigue and physical fitness~   "
149984|NCT01603277|"~     This study will evaluate the safety, tolerability and efficacy of a single dose level of~     KB003 in subjects with inadequately controlled asthma.~   "
149985|NCT01603264|"~     In this study, healthy male volunteers will receive a single intravenous administration of~     either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union). During the~     course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in~     the blood, and by comparing these levels among the different administration arms of~     PF-05280014 and the US-licensed and EU-approved trastuzumab products. Safety, tolerability,~     and immunologic response also will be evaluated throughout.~   "
149986|NCT01603251|"~     The purpose of this study is to determine the safety and impact of ivermectin, administered~     as single or repeated dose, in combination with artemether-lumefantrine in reducing the~     proportion of mosquitoes that survive and become infected after feeding on a blood meal from~     a malaria-infected individual.~   "
150003|NCT01603030|"~     This is a Unicentric, double-blind, randomized, two-arm, parallel-group study to demonstrate~     the efficacy of moxifloxacin/prednisolone acetate fixed combination compared with individual~     administration of moxifloxacin + acetate Prednisolone Eye drops in Prevention of Post~     Operative Inflammation and Infection in LASIK surgery.~   "
155402|NCT01532102|"~     The purpose of this study is to determine the safety, tolerability and efficacy of the~     topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human~     papillomavirus (HPV).~   "
149987|NCT01603238|"~     This was an open-label, non-randomised, single-dose study in 6 healthy male subjects.~     Subjects attended a screening visit within 28 days before drug administration. Subjects were~     admitted to the clinical unit on the morning of the day before dosing (Day -1) and received a~     single oral administration of study drug in a fasted state on Day 1. Subjects were resident~     in the clinic for up to 7 days after dosing; they could be discharged sooner if a mass~     balance cumulative recovery of >95% was achieved, or if a mass balance cumulative recovery of~     >90% was achieved and <1% was collected within 2 separate, consecutive 24 h periods. At~     specified times during the study period, blood samples were taken and urine and faeces were~     collected for PK analysis. Safety assessments were also performed.~   "
149988|NCT01603225|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities, such as speech, language and other efforts at~     communication in individuals with autism.~      In this research, battery powered device is used to deliver very weak electrical current to~     the surface of the scalp while participants are involved in tasks aimed at training or~     measuring communicative efforts, speech, language or related cognitive functions. Our aim is~     to find out whether tDCS will improve these mental abilities.~   "
149989|NCT01603212|"~     The goal of the Phase I part of this clinical research study is to find the highest tolerable~     dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with~     interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this~     combination will also be studied.~      The goal of Phase II is to learn if this study drug combination can help to control advanced~     or metastatic melanoma.~   "
149990|NCT01603199|"~     Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a~     progressive course that can lead to liver cirrhosis. There are few studies on dietary~     management in primary biliary cirrhosis and most of them have focused on micronutrients~     specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent~     hyperlipidemia, but few recommendations have been made regarding a complete dietary approach.~     Fiber has been proven to increase the excretion of nitrogen products and consequently reduce~     its blood levels, and an adequate protein intake (1- 1.5 g per kg) has shown to decrease~     endogenous catabolism in cirrhotic patients.~      The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the~     nutritional status of patients with primary biliary cirrhosis.~   "
149991|NCT01603186|"~     This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single~     dose pivotal study. The purpose of this study is to assess the bioequivalence between Test~     Product and the corresponding Reference Product under fed condition in normal, healthy,~     adult, human subjects.~   "
149992|NCT01603173|"~     This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single~     dose pivotal study. The purpose of this study is to assess the bioequivalence between Test~     Product and the corresponding Reference Product under fasting condition in normal, healthy,~     adult, human subjects.~   "
149993|NCT01603160|"~     The objective of this study is to design, implement and test quality improvement measures to~     improve the care of adults with sickle cell disease in the emergency department.~   "
149994|NCT01603147|"~     The primary objective is to determine the safety and tolerability of single, ascending~     intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse~     event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.Phase 1a,~     randomized, placebo-controlled, first-in-human (FIH) study of intravenously administered~     ch-mAb7F9. The study will be a double-blind, dose-escalation study. Each subject will receive~     a single dose of ch-mAb7F9 or placebo (saline).~   "
149995|NCT01603134|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over comparative pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in normal, healthy, adult, human male subjects.~   "
149996|NCT01603121|"~     The primary goal of the study is to investigate the safety and tolerability of the~     investigational drug lisofylline, when administered under the skin or in the vein, in people~     with type 1 diabetes. A second aim is to determine how much drug is available in the blood~     after injection under the skin, compared to injection in the vein.~   "
149997|NCT01603108|"~     The purpose of this study is to determine if the administration of a poorly-absorbable~     antibiotic (rifaximin) for the first three months after liver transplant will reduce the~     amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent~     hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that~     comes from the bacteria in intestines and may cause scarring in the liver.~      Approximately 60 subjects will participate in this study. Subjects will be part of the study~     for approximately 1 year post transplant.~   "
149998|NCT01603095|"~     Multicenter, multinational study to collect consistent baseline growth measurements on~     pediatric patients with Achondroplasia being considered for subsequent enrollment in future~     studies sponsored by BioMarin. No study drug is administered.~   "
149999|NCT01603082|"~     The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS~     patients undergoing an Ad Hoc PCI~   "
150000|NCT01603069|"~     This is a study where AZD3241 or placebo is given to patients with Parkinson's disease in a~     blinded and randomized assignment. The main objective is to see if safety and tolerability of~     the drug is acceptable.~   "
150001|NCT01603056|"~     Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix~     compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or~     without asthma.~      Sublingual immunotherapy has been used during several years and has been shown to provide~     benefits compare to traditional subcutaneous treatment. This study will investigate if~     improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a~     consequence of being treated under specific immunotherapy.~      This study aim also to contribute to the documentation of tolerability and safety profile of~     Pangramin HDM Mix.~   "
150002|NCT01603043|"~     The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT)~     injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size~     change from baseline at Month 12.~   "
160092|NCT01470612|"~     This study is an open label, long-term extension study for subjects with moderate to severe~     ulcerative colitis designed to evaluate long term therapy of CP-690,550.~   "
150004|NCT01603017|"~     Nuclear Magnetic Resonance Therapy (NMRT) is gaining as a novel mode of therapy in~     osteoarthrosis. A prospective double blind randomised study of 100 patients was conducted to~     investigate efficacy of NMRT in the treatment of mild to moderate osteoarthrosis (OA) of the~     knee joint.~      The null hypothesis was that there is no benefit of NMRT over placebo in mild to moderate~     oteoarthosis of the knee.~   "
150005|NCT01603004|"~     Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic~     neuroendocrine tumors (NETs). In addition, some traditional chemotherapies are often used to~     treat pancreatic NETs. Traditional chemotherapy is also known as cytotoxic therapy and~     works by killing cells that are actively dividing. There have been no studies to compare the~     different types of treatment. Since the patient is eligible for treatment with either~     sunitinib, everolimus or traditional chemotherapy it can help us identify factors that may~     help future patients benefit from these therapies.~   "
150006|NCT01602991|"~     This study aims to determine that this new technology, nasopharyngoendoscopy, is just as~     effective in diagnosing problems as the current gold standard.~   "
150007|NCT01602978|"~     The purpose of this study is to investigate whether a validated sensor that is able to~     measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth~     Variability Index (PVI)] are in your blood during surgery can help your doctors manage how~     much fluid and possibly blood you need to get during your surgery. The hope of the study is~     that the device may provide an early indication you are having bleeding and this may mean you~     need to be treated with a transfusion. Our current method of checking this is by getting a~     blood sample for analysis. The investigators hope is that this device may be able to alert~     the clinician of the need for blood or fluids without a blood draw being needed.~   "
150008|NCT01602965|"~     The purpose of this study is to evaluate the most effectiveness between a personalized~     nutritional program with a counseling monthly phone call Versus personalized nutritional~     program with self help Informative Booklet in a group of obesity or overweight patients~     without counseling phone call.~   "
150009|NCT01602952|"~     A Phase I/II multicenter study of IY5511HCl in Philadelphia chromosome positive chronic~     myeloid leukemia patients without optimal response or tolerance to Bcr-Abl tyrosine kinase~     inhibitors (Imatinib and/ or Dasatinib, Nilotinib) In this study, The efficacy and safety of~     CML patients who are resistant or intolerable to imatinib in the Chronic and Accelerated~     phases.~      Phase 1~      1. To investigate the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicity (DLT) of~     oral Radotinib HCl bid (twice daily) in the Philadelphia chromosome-positive CML subjects who~     are resistant, suboptimal responsive, or intolerant to imatinib OR resistant or intolerant to~     at least one second-generation targeted anticancer agent while being resistant, suboptimal~     responsive, or intolerant to imatinib simultaneously.~      Phase 2~        1. To investigate safety of oral Radotinib HCl in CML patients who are resistant or~          intolerable to imatinib in the chronic and accelerated phases.~        2. To evaluate hematologic and cytogenetic efficacy of oral Radotinib HCl in CML patients~          who are resistant or intolerable to imatinib in the chronic and accelerated phases.~   "
150010|NCT01602939|"~     The aim of this study is to evaluate the efficacy in terms of clinical and biological~     response rates of Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with~     advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.~   "
150011|NCT01602926|"~     Hallux valgus is a common deformity of the big toe, defined as medial deviation of the first~     metatarsal bone along with lateral deviation of the first toe. Surgery has been shown to be~     beneficial when compared to orthotics or no treatment. While generally effective, surgery is~     associated with significant post-operative pain and disability, with several weeks of limited~     mobility. Minimally invasive techniques have the potential to lead to increased patient~     satisfaction while still achieving adequate correction of the deformity.~      This trial is a non-inferiority treatment study, with open-label, randomized, prospective,~     controlled, parallel experimental design, to compare the clinical and radiographic outcomes~     of a minimally invasive surgery versus a conventional surgery for hallux valgus. This trial~     examines two different surgical interventions. No drug or device is being evaluated in this~     trial.~      60 to 100 patients, over the age of 18 years, undergoing surgical correction of mild to~     moderate hallux valgus will be enrolled in the trial. The patients will be randomized to two~     groups, one treated with a conventional distal osteotomy surgery, the other treated with a~     minimally invasive surgery. Randomization will occur immediately prior to surgery via a~     multitude of opaque envelopes containing a coded group assignment. Due to the differences in~     the techniques, neither the investigator and the subject can be effectively blinded to the~     group assignment. Data collection for the outcomes measures will occur preop, and then post~     of at 2 weeks, 12 weeks, and at 1,2, and 3 years.~      The primary outcomes measure is the Manchester-Oxford Foot Questionnaire Score (MOXFQ).~     Manchester-Oxford Foot Questionnaire' (MOXFQ), a 16 item patient-reported questionnaire~     consisting of three domains/scales: 'Walking/standing' (seven items), 'Pain' (five items) and~     'Social interaction' (four items). The MOXFQ is a validated disease-specific outcomes scale~     for foot and ankle surgery which has been shown to be responsive and reliable.~      Secondary outcome measures are preoperative to postoperative change in hallux valgus angle~     (HVA). Radiographic outcomes parameters will be measured using weight-bearing radiographs to~     analyze preoperative and postoperative hallux valgus angle, and the correction or~     normalization thereof. (Degrees of correction = 2 week preoperative HVA - 12 week~     postoperative HVA.)~   "
150012|NCT01602913|"~     Type 2 Diabetes (T2DM) is a life-long, chronic condition affecting an individuals' ability to~     regulate glucose levels in the blood. Diabetes can cause many severe complications if not~     treated properly. Hyperglycemia is a regular effect of uncontrolled diabetes and can lead to~     complications such as cardiovascular disease, chronic renal failure, diabetic retinopathy and~     inability to maintain a healthy body weight.~      Cardiovascular Disease (CVD) is now the leading cause of death worldwide, affecting millions~     of people in both developed and non-developed countries. The buildup of cholesterol in the~     bloodstream may cause the excess to be deposited in the coronary arteries of the heart and~     the carotid arteries of the brain. The cholesterol deposits are a factor of the plaques that~     cause blockage of the arteries which can in turn lead to heart disease and stroke. By~     lowering the blood levels of cholesterol, risks of heart disease, strokes and heart attacks~     are reduced. Medications such as HMG-CoA reductase inhibitors and fibrates are useful in the~     prevention of CVD.~      Pravastatin is a member of the drug class of statins, also known as HMG-CoA reductase~     inhibitors, and is shown as an adjunctive therapy to diet. It is known to reduce the amount~     of cholesterol and other fatty substances in the blood. In addition, pravastatin is indicated~     to reduce the risk of myocardial infarction, revascularization and cardiovascular mortality~     in hypercholesterolemic patients who do not have clinically apparent coronary heart disease.~     The recommended starting dose for adults is 40 mg once daily. For patients who do not reach~     the LDL-C goal with 40 mg, it is recommended to use an 80 mg dose. For persons with~     significant renal impairment the recommended dose is 10 mg. Children aged 8-13 years have a~     recommended starting dose of 20 mg daily. Adolescents aged 14 to 18 years have a recommended~     starting dose of 40 mg daily.~      Depression is known as the most common mental disorder and most prevalent type of mood~     disorder today. It can be seen as a state of mood, a symptom, a syndrome or as a clinical~     diagnosis. Depression is a common disorder, affecting about 121 million people worldwide.~     Depression is more likely to co-occur with medical illnesses such as stroke, heart disease,~     cancer and diabetes. Up to one-quarter of people with diabetes are estimated to experience~     depression which is two times more than those who do not suffer from diabetes. Studies have~     shown that major depression mainly occurs in 2¬4 percent of people in the community, in 5-10~     percent of primary care patients and 10-14 percent of medical inpatients. Also, recent~     studies have estimated that the symptoms continue over a 6 month to one year period in~     patients with major depression. The severity of the symptoms and the incidence of medical~     illness are expected to predict the persistence of depression. Depression can be treated~     effectively by a variety of antidepressants and/or psychotherapies. If treated appropriately,~     over 80 percent of people who suffer from depression can be helped.~      Paroxetine is an orally administered selective serotonin reuptake inhibitor (SSRI)~     antidepressant. It was the first antidepressant that was formally approved in the United~     States for the treatment of panic attacks, major depression, post¬traumatic stress disorder,~     social anxiety, generalized anxiety disorder, panic disorder and obsessive-compulsive~     disorder. Paroxetine has a well-established safety profile and it shares the common side~     effects and contraindications of other SSRI's which include nausea and somnolence and is~     associated with weight gain.~      This study proposes to conduct a retrospective cohort study to assess the risk of new onset~     diabetes among patients undergoing treatment with Pravastatin or other statins, and~     Paroxetine or other SSRI's. This study will compare the risk of co administration of two drug~     classes versus the use of each agent alone. In addition, the risk among patients prescribed~     Paroxetine and fibrates in combination, relative to the use of Paroxetine singly, will be~     examined to determine whether any interaction found between Paroxetine and statins extends to~     other drugs indicated for hypercholesterolemia.~      The first primary objective of the study is to estimate the incidence of Type 2 Diabetes~     (T2DM) among patients newly exposed to pravastatin in combination with paroxetine, or other~     SSRIs, compared to those newly exposed to pravastatin alone. The second primary objective is~     to estimate the incidence of Type 2 Diabetes (T2DM) among patients newly exposed to~     paroxetine in combination with pravastatin, other statins, or fibrates, compared to those~     newly exposed to paroxetine alone.~   "
150013|NCT01602900|"~     This study will investigate if a new experimental drug to treat Huntington's Disease gets~     into the brain. If it does get into the brain the study will explore the relationship between~     the amount of drug in the brain and the amount of drug in the blood. The study will involve~     healthy male volunteers.~   "
150014|NCT01602887|"~     This is a BA study comparing the bioavailability of two new capsule formulations and one~     solution formulation to the isethionate capsule used in phase 1 and 2 trials in healthy~     volunteers.~   "
150015|NCT01602874|"~     The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone~     regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal~     infections (cIAI) and community acquired pneumonia (CAP).~   "
150016|NCT01602861|"~     The purpose of this study is to assess whether the diuretic drug spironolactone can prevent~     chronic damage to transplanted kidneys caused by the medication that prevents rejection.~      Spironolactone prevents the effects of the hormone aldosterone. Aldosterone is suspected of~     being involved in the processes leading to chronic rejection of transplanted kidneys. Hence,~     by blocking the effects of aldosterone we hope to be able to prevent loss of kidney function~     in transplant patients.~   "
150085|NCT01601964|"~     The aim of this study is to determine plasma Vascular Endothelial Growth Factor level and~     change in patient with ectopic pregnancy who needs to surgical treatment.~      Patient with ectopic pregnancy diagnosed and treated with medically or surgically will be~     included in the study. This is an observational study.The plasma Vascular Endothelial Growth~     Factor level will be measured first day and two day after the diagnosis of ectopic pregnancy.~   "
150017|NCT01602848|"~     Medicaid-insured patients with frequent hospitalizations account for a disproportionate share~     of visits and costs, and have caught the attention of policy makers, creating an impetus for~     hospitals and health care providers to better understand and control associated expenditures.~     Many such patients have specific unmet health and social needs. Based on our extensive pilot~     work with this population, the New York State Department of Health recently awarded the New~     York City Health and Hospitals Corporation one of seven statewide contracts to implement a~     Chronic Illness Demonstration Project, aimed at improving care and reducing healthcare~     expenditures for high cost Medicaid patients. Within this framework, the investigators~     propose a group-randomized trial design to test whether specific outcomes related to health,~     functional status, and quality of life resulting from a patient-centered, intensive care~     coordination and management intervention correlate with improved linkage to primary care~     while reducing hospitalizations and emergency department visits. The investigators will then~     relate these benefits to program costs using standard cost-effectiveness analysis techniques.~     Given that there are few examples of successful interventions for this population and~     currently unparalleled Medicaid spending, there is an urgent need to demonstrate that~     interventions to improve care coordination and optimize patients' use of the health and~     social care system result in more efficient and less costly care.~   "
150018|NCT01602835|"~     This is a prospective cross-sectional, observational, single-center study of Alport patients,~     in which a single, first morning voided urine collection will be acquired and used to~     validate assays of urine biomarkers that reflect changes in glomerular protein filtration~     barrier function.~      The purpose of this study is to identify biomarkers indicative of changes in glomerular~     filtration function that occur during the course of proteinuric renal diseases such as Alport~     nephropathy.~   "
150019|NCT01602822|"~     This study will evaluate how safe and tolerable a combination of taking three-drugs will be~     for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in~     HIV uninfected adults.~   "
150020|NCT01602809|"~     Background:~      - Small blood vessels (microvessels) in many different organs are affected by diseases such~     as diabetes and atherosclerosis. These microvessels may also be abnormal in people who have~     sickle cell disease. Stiffness of the red blood cells leads to problems in the microvessels~     of the heart and kidneys. However, these problems may not be detected until these organs are~     severely affected. Researchers want to study problems with microvessels in people with and~     without sickle cell disease.~      Objectives:~      - To study how microvessels in the heart and other organs are affected by sickle cell~     disease.~      Eligibility:~        -  Individuals at least 18 years of age who have sickle cell disease.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  All participants will have about 3 to 4 hours of testing for the study. Participants~          with sickle cell disease who are having a pain crisis at the time they enter the study~          may be asked to have the testing again when the crisis is over. The repeat testing will~          occur at least 4 weeks after the pain crisis ends.~        -  All participants will have the following tests:~        -  Blood draws to check kidney and liver function, and other blood tests~        -  Measure of blood flow in the brachial (upper arm) artery~        -  Heart ultrasound~        -  Ultrasound scans of arm muscles to study blood flow~        -  Ultrasound scans after taking vasodilators to increase blood flow~        -  Healthy volunteers will also have a magnetic resonance imaging scan. It will show blood~          flow in the heart. This scan will involve another dose of a vasodilator.~   "
150021|NCT01602796|"~     In this multicenter cluster randomized controlled trial stratified by school baseline~     prevalence of smoking will be randomly allocated to the control or intervention group.~     Control schools will receive normal smoking education and intrvention schools will receive a~     four year class-based curriculum intervention (22 Classroom lessons), reinforcement of~     smoke-free school policy, smoking cessation in parents, pupils, and teachers and information~     and annual meeting with parents.~      Study participants will be children aged 12 to 15 years old ; they will be followed to 2~     years after high school. External evaluator and analyst will be blinded to school allocation.~      The aim of this study is to analyze the effectiveness of a complex intervention to reduce the~     prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18 yrs-old)~     .~   "
150022|NCT01602783|"~     This research is being conducted to test an imaging technique that may be able to detect~     small amounts of prostate cancer that can not be detected by standard imaging.~      Many patients who are diagnosed with prostate cancer undergo surgery to remove the prostate.~     After this surgery, some patients have a PSA blood test that reveals a low but detectable~     level of PSA. This PSA may be produced by cancer cells in one of two locations: (1) near the~     area where the prostate used to be, or (2) elsewhere in the body. If the cancer is only in~     the area where the prostate used to be, it can be successfully treated with radiation to that~     area. If the cancer is elsewhere, radiation is not helpful. Currently, there is no available~     scan that can detect cancer when the PSA is still so low.~      The test used in this study is called [11C] acetate PET screening. [11C] acetate is a~     radioactive tracer that is given by vein to patients before PET scanning. The PET scanner~     then detects radioactivity from the tracer that is attached to cells within your body and~     uses this information to create images (pictures) on a computer screen.~      [11C] acetate PET scanning has been shown in early studies to detect smaller amounts of~     prostate cancer that can be detected by standard imaging tests such as CT scan and bone scan.~     If it is successful at detecting very small amounts of prostate cancer, [11C] acetate PET~     scanning will help doctors identify patients who will benefit from radiation therapy after~     their prostate has been surgically removed. It will also help them identify patients who have~     small amounts of prostate cancer in other parts of the body and will not benefit from~     radiation to the prostate area.~      This type of PET scan is investigational. Investigational means that the scan is still~     being studied and that research doctors are trying to find out more about it. It also means~     that the FDA has not approved this type of PET scan for your type of cancer. The information~     collected by this scan will determine whether this type of scanning is helpful but it will~     not be used to make decisions about your medical care.~   "
150036|NCT01602601|"~     Study IDS116406 will be a non-interventional, phlebotomy study in Hunter Syndrome patients~     who are currently being treated with idursulfase, an enzyme replacement therapy, and in at~     least a single patient who is naïve to treatment, if possible to recruit. All patients~     enrolled into the study will have a single blood draw for the analysis of antibodies induced~     by this enzyme replacement therapy (idursulfase). Patient samples with positive responses to~     antibodies induced by idursulfase will be used to further evaluate whether the antibodies~     induced by idursulfase bind to GSK2788723 molecules in vitro and if these antibodies~     neutralize the bioactivity of GSK2788723 in vitro. Each subject will have a screening visit,~     which may occur at their regularly scheduled out-patient visit. If the patient consents to~     participate in the study, a blood sample (total volume of approximately 3mL) for~     immunogenicity analysis will be drawn before their current treatment infusion~   "
160093|NCT01470599|"~     The study hypothesis is to establish the safety and tolerability of long-term open-label (OL)~     CP-690,550 therapy in subjects with Crohn's disease.~   "
150023|NCT01602770|"~     Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being~     the first oral contraceptive delivering estradiol. It has been recently approved in Mexico.~     To evaluate the clinical profile of this drug combination under routine medical condition, a~     post-authorization safety study required by Mexican Health Authorities will be conducted in~     Mexican women.~      The study will be performed as a descriptive study, no hypothesis will be tested. The cohort~     consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical~     conditions. Subjects should provide all necessary information on health-related events or~     changes in health status during Qlaira use.~      Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or~     not related to Qlaira during at least 2 years of observation.~      In order to comply with the criteria of a non-interventional study, women only will be~     informed about the study, asked to participate and included in the study after Qlaira has~     been prescribed.~      Study patients follow-up will be done in accordance with common clinical practice as~     described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM~     005-SSA2-1993).~   "
150024|NCT01602757|"~     This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-, and~     12-hour application of 4 Synera patches and a 4 hour application of 4 patches without heat.~   "
150025|NCT01602744|"~     The purpose of this study is to determine if the use of STOPP/START criteria (STOPP-screening~     tool of older persons potentially inappropriate prescriptions START-screening tool to alert~     doctors to right treatment)for medication intervention in elderly population living in a~     geriatric hospital will lower the number of falls,hospitalization,will improve functioning,~     quality of life and reduce financial costs.~   "
150026|NCT01602731|"~     Trialing an automated medication dispensing device (AMDD) to improve medication adherence in~     patients with heart failure.~   "
150027|NCT01602718|"~     This study will compare physical activity levels and physical functioning in patients treated~     with home dialysis vs. those treated with in-center dialysis. The investigators will first~     compare prevalent patients, and will also compare the two groups longitudinally in incident~     patients over the first 18 months of beginning the dialysis treatments. Patients will be~     tested for physical functioning using standard performance-based testing such as gait speed,~     chair stand, balance test, as well as self-reported limitations in activities of daily~     living. The investigators will monitor physical activity using step counters and activity~     questionnaires. Blood samples will be drawn at each testing time to measure inflammatory~     markers. A pilot study of home dialysis patients will be done to determine the effects of an~     independent home-based exercise program on physical functioning and inflammatory markers. For~     this pilot study, 30 patients will be randomized into exercise intervention and usual care~     with testing at baseline and again after 3 months of the intervention.~   "
150028|NCT01602705|"~     We hypothesise that feedback and feedback + psychology informed intervention delivered to~     primary care medical practices will reduce high-risk prescribing to patients compared to a~     simple educational intervention alone. The specific objectives are :~        1. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified~          primary outcome of a composite measure of high-risk antipsychotic, non-steroidal~          anti-inflammatory drug, and antiplatelet drug prescribing~        2. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified~          secondary outcomes of the six individual measures constituting the composite~        3. To assess the cost-effectiveness of the intervention~   "
150029|NCT01602692|"~     The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent~     solution containing both dilute lidocaine and epinephrine will lead to better control of~     postoperative pain, nausea, vomiting, shorter time through postoperative phases of care,~     quicker discharge from the hospital and lower numbers of hospital readmissions than the use~     of tumescent solution containing only dilute epinephrine.~   "
150030|NCT01602679|"~     The rapidity with which progesterone slows LH (and by inference GnRH) pulse frequency in~     women is unclear. The investigators hypothesize that progesterone slows LH pulse frequency~     within 10 hours. The investigators propose to assess this further with a randomized,~     cross-over, placebo-controlled study. Regularly cycling women without hyperandrogenism will~     be admitted to the Clinical Research Unit on cycle day 5-9 (mid-follicular phase) for a 10~     hour frequent sampling study to observe LH, FSH, estradiol, progesterone, and testosterone.~     Either oral micronized progesterone suspension or placebo will be administered at 0900 h.~     During a subsequent menstrual cycle, subjects will undergo another study identical to the~     first except that oral progesterone will be exchanged for placebo or vice versa in accordance~     with a crossover design.~   "
150031|NCT01602666|"~     Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy~     with radiation therapy may kill more tumor cells. This phase II trial studies how well~     chemotherapy and radiation therapy work in treating younger patients with newly diagnosed~     central nervous system germ cell tumors.~   "
150032|NCT01602653|"~     The purpose of this study is to compare two different ranges of energy flux density with~     Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis.~   "
150033|NCT01602640|"~     Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and~     extubation, as compared to the combination of fentanyl and midazolam in critically-ill~     patients.~   "
150034|NCT01602627|"~     This phase I trial studies the side effects and best dose of Hsp90 inhibitor AUY922 in~     treating older patients with advanced solid malignancies. Hsp90 inhibitor AUY922 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth~   "
150035|NCT01602614|"~     This is a clinical sampling study, and no study drugs will be administered under this~     protocol. Premature infants who receive intravenous ganciclovir as part of clinical care will~     be eligible for participation in this study. Intravenous ganciclovir will not be provided~     under this protocol.~   "
150037|NCT01602588|"~     There is emerging evidence that hydroxychloroquine (HCQ), a drug used commonly in the~     prevention/ treatment of malaria, rheumatoid arthritis and lupus erythematosus, may improve~     survival outcome in a variety of cancers including HGG, with few side effects.~      In this trial the investigators wish to investigate whether treatment with radiotherapy and~     hydroxychloroquine is more effective than treatment with radiotherapy alone.~   "
150038|NCT01602575|"~     The purpose of this study is to use functional magnetic resonance imaging (fMRI) to evaluate~     brain resting state networks, responses to abdominal stimuli and the effect of MBSR Training~     on these measures. The goal of this study is to identify biomarkers of IBS and assess the~     responsiveness these biomarkers after MBSR Training. A biomarker, or biological marker, is in~     general a substance or measure used as an indicator of a biological state. It is a~     characteristic that is measured and evaluated as an indicator of normal biological processes,~     disease processes, or responses to a therapeutic intervention, in this case MBSR.~   "
150039|NCT01602562|"~     The purpose of this study is to evaluate the preventive efficacy for HSV infection and safety~     of valaciclovir (VACV) in the adult and pediatric HSCT patients.~   "
150040|NCT01602549|"~     Gastric emptying is the end-result of a complex and carefully regulated series of events~     which follow the ingestion of a meal, each of which is dependent on the other and subject to~     neurohormonal control. Motilin is an endogenous peptide, produced mainly in the duodenum,~     whose physiological action is mediated by motilin receptors located on enteric neurons,~     peripheral terminals of the vagus, and on the smooth muscle of the gut. Motilin and~     non-peptide agonists at motilin receptors increases the gastric emptying rate and therefore~     provide a potential approach to the treatment of a range of clinical conditions in which~     delayed gastric emptying is thought to be part of the physiopathology and may be contributory~     to symptoms. Parkinson's disease (PD) is a progressive neurodegenerative disorder~     characterized by degeneration of nigrostriatal dopaminergic neurones. It affects 1.5% of the~     global population over 65 years of age. Cardinal symptoms comprise bradykinesia, rigidity,~     resting tremors and postural instability. Gastrointestinal dysfunction, including~     gastroparesis, is a frequent feature of PD affecting approximately 90% of patients, and is~     caused by autonomic dysfunction as well as an adverse effect of antiparkinsonian drug~     therapy. The therapeutic mainstay for PD treatment is the neutral amino acid~     L-3,4-dihydroxyphenylalanine (L-DOPA), a dopamine prodrug, as it provides the most rapid and~     effective symptomatic control of motor impairment in PD. The primary determinant of L-DOPA~     bioavailability is gastric emptying (GE); delays in GE slow delivery of L-DOPA to its~     proximal small intestinal absorption sites, increasing the extent of presystemic metabolism,~     and leading to slowed and diminished absorption.~   "
150041|NCT01602536|"~     In Phase I (N=40), we developed a treatment protocol for smoking cessation and relapse~     prevention that used virtual quit-smoking Twitter groups and Twitter-enabled interactive peer~     messaging. We tested and refined this protocol using two quit-smoking Twitter groups. In~     Phase II (N=160), we conducted a two-arm (test vs. control) randomized controlled trial of~     the treatment protocol created in Phase I. In Phase III (N=80) we ran additional quit-smoking~     Twitter groups and tested various interventions to increase engagement in the intervention,~     e.g., peer leaders. This research provided crucial data about the viability and methodology~     to be used in a larger randomized controlled trial that would directly measure smoking~     behavior.~   "
150042|NCT01602523|"~     This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an~     inhaled medication that contains 2 drugs. One is a medication that opens up the airways~     (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort~     is not an experimental medication. It is approved by the Food and Drug Administration for use~     in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause~     of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening~     the airways and reducing lung inflammation. It is not known for sure if these effects~     actually improve sleep and quality of life. It is hoped that this study will answer this~     question.~   "
150043|NCT01602510|"~     This registration study in China is a multi-centre, double-blind, placebo-controlled clinical~     trial to evaluate the efficacy and safety of lamotrigine in the prevention of~     recurrence/relapse of mood episodes in subjects with bipolar I disorder. Subjects are bipolar~     I disorder patients with recent/current manic, hypomanic, mixed or depressive episode. The~     study will include an open-label phase and a randomized phase. During the open-label phase,~     subjects will have lamotrigine monotherapy or combination therapy escalation. The target dose~     of lamotrigine is 200 milligram (mg)/day monotherapy. The duration of treatment in the~     open-label phase will last 6-16 weeks, until subjects reach a stable dose of lamotrigine.~     Beginning at week 7 of the open-label phase, subjects who have reached a stable dose of~     lamotrigine and met response criteria, defined as maintaining a Clinical Global Impression of~     Severity (CGI-S) score <= 3 for at least 4 continuous weeks and maintaining lamotrigine 200~     mg/day monotherapy for at least 1 week, will be eligible to enroll in the double-blind phase~     of the study. Subjects who have not met response criteria after 16 weeks of participation in~     the open-label phase will be withdrawn from the study. Subjects will have lamotrigine 200~     mg/day monotherapy for at least 1 week prior to randomization. Subjects who have met~     randomization requirements will be randomized 1:1 to lamotrigine 200 mg/day or placebo for 36~     weeks double-blind treatment. After randomization, subjects will be assessed at weekly~     intervals for the first month, biweekly intervals for the second month, and then at monthly~     intervals for up to 36 weeks of double-blind treatment. The primary endpoint will be TIME,~     defined as the time to intervention (addition of pharmacotherapy or electroconvulsive therapy~     [ECT]) for any mood episode (relapse or recurrence of a depressive, manic, hypomanic or mixed~     episode) after randomization. The secondary endpoints will include time to intervention for~     manic, hypomanic or mixed episode (TIMan) and time to intervention for depressive episode~     (TIDep).The scores on the Hamilton Depression (HAMD), Young Mania Rating Scale (YMRS), CGI-I,~     CGI-S and Global Assessment Scale (GAS) will be used as indicators for both intensity and~     duration of mood symptoms during this phase. Subjects who withdraw early from the study prior~     to week 36 or reach TIME will have a follow-up visit 14 days after the last dose of~     investigational drug.~   "
150044|NCT01602497|"~     This study is going to evaluate the effects of repetitive transcranial magnetic stimulation~     (rTMS) on Borderline Personality Disorder patients symptoms.~   "
150045|NCT01602484|"~     The investigators wish to perform a randomized controlled study to determine how much time~     and money is saved by orthopedic foot and ankle surgeons through the use of prepared splint~     packs compared to bulk supplies.~   "
150046|NCT01602471|"~     This trial will be the first trial for the Investigation Product (IP), [F-18]RGD-K5 for~     carotid plaque imaging and will be conducted as a Phase II trial since this compound has~     already been tested in humans for phase I and phase II imaging. All study results will be~     evaluated and analyzed in order to consider the design for future clinical trials.~   "
150047|NCT01602458|"~     The study's objective is to compare the global scar outcomes in those treated with silicone~     only therapy (SOT) versus silicone pressure garment therapy (SPGT) for the prevention of~     hypertrophic scarring in children with skin grafts after traumatic skin injury.~   "
150062|NCT01602263|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities. In this research, battery powered device is used~     to deliver very weak electrical current to the surface of the scalp while participants~     complete cognitive tasks. Our aim is to find out whether tDCS will improve task performance~     in both healthy adults and those with neurological impairment.~   "
151865|NCT01578564|"~     The purpose of this study is to determine the safety and tolerability of the drug SOR-C13~     when given as an intravenous infusion in patients with ovarian cancer or other cancers known~     to over express the TRPV6 calcium channel.~   "
150048|NCT01602445|"~     The presence of clots in the veins of arms and/or legs or lungs of Cancer patients decreases~     their quality of life, delays their treatment and may cause death. The best way to avoid new~     clots is by giving blood thinners before clots are formed, but even some patients who are~     taking blood thinners may form blood clots. A major problem is that it is difficult to know~     which patients form clots while they are receiving blood thinners, a situation called~     treatment failure. Several studies have shown that by doing blood tests that measure the~     formation of clots, the investigators could know if the patient is responding to the blood~     thinners. If this is proven, the investigators will be able to apply these tests to all~     patients.~   "
150049|NCT01602432|"~     Cancer increases the risk of deep vein blood clots and clots traveling to the lungs (emboli)~     which cause morbidity (leg swelling, pain, and shortness of breath), sudden death, delays~     cancer treatment, and decreases cancer survival by 66% compared to similar cancer patients~     without blood clots. Blood thinners may prevent clots but major bleeding is also a problem,~     so preventive therapies are not used routinely. Identifying patients at highest risk for~     clots is critical. A tool exists but it has not been used outside of research. We propose to~     study how to apply this tool in clinical practice and test if it works.~   "
150050|NCT01602419|"~     This is an observational study, hence there is no study hypothesis~   "
150051|NCT01602406|"~     This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum~     Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination~     with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2)~     overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of~     a dose escalation part and a dose expansion part. LJM716 will be administered intravenously~     once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks~     is introduced. Patients will continue on their trastuzumab dosing, administered intravenously~     once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be~     treated in successive cohorts. The dose escalation will continue until the MTD/RDE is~     declared. The RDE dose selected will either be the MTD or a dose below the MTD based on~     safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE~     declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in~     the dose expansion part and treated at the MTD/RDE to further assess the safety,~     tolerability, and anti-tumor activity of the combination.~   "
150052|NCT01602393|"~     The purpose of the study is to evaluate the safety and tolerability of ascending oral doses~     of CHF 5074 after prolonged administration to patients with mild cognitive impairment.~   "
150053|NCT01602380|"~     The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or~     Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or~     metastatic breast cancer who have not had prior hormonal treatment.~   "
150054|NCT01602367|"~     The purpose of this study is to determine whether BMS-823778 is safe and effective in the~     treatment of hypertension in overweight and obese patients.~   "
150055|NCT01602354|"~     The purpose of this observational study is to determine whether endotoxin levels and/or their~     trends can be considered predictive of morbility or mortality in septic shock caused by~     gram-negative bacteria, searching also for a possible correlation with Simplified Acute~     Physiology Score (SAPS II), Sequential Organ Failure Assessment (SOFA), White Blood Cells~     (WBC) and Platelets (PLT).~   "
150056|NCT01602341|"~     The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment,~     2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of~     adolescents with atopic dermatitis (AD)~   "
150057|NCT01602328|"~     Subjects entering the study will have undergone cardiac surgery. Those who experience kidney~     injury within 48 hours of their surgery will be enrolled into the study. Once enrolled,~     subjects will receive a single administration of AC607 or placebo. Kidney recovery will be~     evaluated over the subsequent 30 days and death or the need for dialysis will be evaluated~     within 90 days of dosing. After 90 days (evaluation period), subjects will enter a 3-year~     extension phase of the study to monitor safety and long-term outcomes (follow-up period).~   "
150058|NCT01602315|"~     This was a multi-center, open-label, Phase Ib dose escalation /Phase II study in recurrent or~     metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be~     resistant, ineligible or intolerant to platinum-based chemotherapy. The Phase Ib included~     three arms. Three different methods of administration and two different BYL719 formulations~     were studied to determine the MTD and/or RP2D of BYL719 in combination with cetuximab:~      Arm A - film-coated whole tablets were orally administered to patients who were able to~     swallow the tablets; Arm B - a drinkable suspension prepared from crushed film-coated tablets~     was administered orally to patients with swallowing dysfunction Arm C - a suspension from a~     dispersible tablet administered via G-tube, in patients with swallowing dysfunction. Arm C~     was used to investigate the pharmacokinetics (PK), compared to Arm A (film coated tablet),~     and safety of the dispersible tablet of the dispersible tablet formulation of BYL719.~      The Phase II investigated the clinical efficacy of BYL719 and consisted of an open label,~     randomized Phase II part investigating BYL719 in combination with cetuximab compared to~     cetuximab alone in patients resistant or intolerant to platinum and naïve to cetuximab~     (Scheme 1: Arm 1 and Arm 2), and a non-randomized Phase II part Scheme 2: Arm 3. In addition,~     patients who experienced disease progression in Arm 2 (cetuximab) were allowed to switch to~     the combination regimen (cross-over, Arm 2B). The safety of the BYL719 in combination with~     cetuximab was also further characterized in Arms 1, 2B and 3.~      Patients were treated until progression of disease), unacceptable toxicity, or withdrawal of~     informed consent, whichever occurred first (except for phase II Arm 2 had the opportunity to~     crossover to the combination treatment (Arm 2B). In the follow-up period all patients had to~     complete the safety follow-up assessments within 30 days after the last dose of the study~     treatment. Patients who did not have disease progression at the time of discontinuation of~     study treatment were radiologically followed for disease status until disease progression,~     initiation of subsequent anticancer therapies, or death, whichever occurred first. In~     addition, all patients enrolled in Phase II were followed for survival.~   "
150059|NCT01602302|"~     biological DMARDs may be stopped in Rheumatoid Arthritis (RA) patients treated with a~     combination of synthetic DMARD plus bDMARDs which are in persistent clinical remission. The~     research question of this study is, whether musculoskeletal sonography is a useful biomarker~     predicting a disease flare after cessation of bDMARD therapy.~   "
150060|NCT01602289|"~     The purpose of this study is to assess the safety and tolerability of LY2875358 in Japanese~     participants with cancer that is advanced and/or may have spread to another part of the body.~   "
150061|NCT01602276|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain abilities related to cognition, emotion and/or physical~     functioning in individuals with subcortical brain damage.~   "
150250|NCT01599819|"~     The objectives of this study are to assess the tolerability and safety after single dose~     treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to~     determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE,~     and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.~   "
150063|NCT01602250|"~     The systemic toxicity of local anaesthetics may be treated using lipid emulsions (lipid~     rescue). However, there is no evidence-based proof of the efficacy of the treatment. The aim~     of the intended protocol is to study the effect of the emulsion Intralipid® on the toxicity~     prodromes in volunteers receiving either levobupivacaine or ropivacaine. After a~     sensitization session with lidocaine, subjects will receive in a double blind, crossover~     manner an i.v. infusion of levobupivacaine or ropivacaine followed by a rapid infusion of~     Intralipid®. The primary outcome will be the time of appearance of early neurologic signs of~     toxicity. In addition, the EEG and ECG will be monitored and blood sampling will be performed~     in order to evaluate the changes in pharmacokinetics induced by the emulsion.~   "
150064|NCT01602237|"~     The study is a follow-up of investigations done in the years 1999-2002 in bakery employees.~     The main purposes are to look at the associations between flour dust exposure and respiratory~     disease, and to find out the best ways to reduce the flour dust levels in the working~     environment.~   "
150065|NCT01602224|"~     The purpose of this study is to evaluate an investigational drug called tabalumab in~     participants with Multiple Myeloma (MM) who have tried at least one other therapy in the~     past. Tabalumab will be given in combination with standard doses of two other drugs that are~     often used to treat MM. Study doctors will collect information about the effectiveness and~     side effects of this therapy.~   "
150066|NCT01602211|"~     This randomized clinical trial studies an internet and social-media program for improving~     quality of life in long-term survivors who underwent stem cell transplant. In this study,~     researchers want to compare a survivorship internet program to the standard treatment of~     currently available internet sites for transplant survivors to learn which works better for~     people who have received bone marrow or blood stem cell transplants. A survivorship-focused~     internet program may improve mood, stress, and preventive health care, and provide useful~     health resources for transplant survivors. It is not yet known whether currently available~     internet sites are more effective than a survivorship-focused internet program in improving~     quality of life in cancer survivors.~   "
150067|NCT01602198|"~     The goal of this project is to determine if task-activated fMRI is sensitive to the central~     cholinergic deficit associated with Mild Cognitive Impairment.~   "
150068|NCT01602185|"~     The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to~     ketamine maintains or induces a decrease of pain intensity.~      In clinical, after ketamine cure, clinicians have often difficulties to treat patients in~     order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was~     not effective, which occurs in one quarter of patients. It will be very useful for monitoring~     of painful patients evaluate if memantine or dextromethorphan could be an effective~     therapeutic alternative in neuropathic pain treatment.~   "
150069|NCT01602172|"~     Veterans drink, binge drink, and drive under the influence of alcohol at higher rates than~     non-Veterans do. Addressing alcohol misuse, the range of alcohol consumption from risky~     drinking to alcohol abuse and alcoholism, is a national priority for the VA. It is~     recommended that people keep their alcohol consumption below limits established by the~     National Institutes of Health (NIH). A type of 10-15 minute counseling known as brief~     intervention (BI) has been shown to help risky drinkers cut back to the NIH-recommended~     limits. This study will examine the impact of a nurse-delivered alcohol BI on hospitalized~     Veterans' weekly number of drinks, monthly number of binge drinking episodes, readiness to~     change drinking behavior, and alcohol-related problems. This preventative approach for~     reducing alcohol consumption is intended to help Veterans avoid many of the physical and~     psychosocial consequences of alcohol misuse.~   "
150070|NCT01602159|"~     This is a prospective randomized controlled trial to compare clinical improvement, cost~     effectiveness and patency rates between new and improved Nitinol stents and open bypass~     surgery in the superficial femoral artery disease.~      Secondary outcomes also include comparing quality of life, re-intervention rate, mortality,~     morbidity and time to return to work or regular activities.~      Patients with superficial femoral artery lesions will be considered. Patients with TASC II A~     lesions will not be randomized but treated with PTA/stenting as standard of care. Patients~     with TASC II B and C lesions will be prospectively randomized into either receiving open~     bypass or stenting.~      Patients with TASC D lesions will be treated with open bypass surgery after angiography.~      The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on~     all enrolled the patients.~   "
150071|NCT01602146|"~     Acute physiological consequences of ultramarathon running are still unknown, particularly in~     women. Results from the investigators first studies conducted in 2009 have shown that a large~     part of fatigue induced by a mountain ultramarathon could be attributed to central fatigue.~     The investigators have investigated the biological consequences and neuromuscular fatigue~     only in male runners. Data from the literature suggest that amplitude and etiology of fatigue~     after prolonged exercise might be gender-dependant.The main purpose of the present project is~     thus to quantify supraspinal central fatigue and associated changes in cortical excitability~     after an extreme exercise such as a mountain ultramarathon: the Ultra-Trail du Mont-blanc, by~     using TMS.~   "
150072|NCT01602133|"~     Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous~     catheter during a period of seven days.~   "
150073|NCT01602120|"~     This is a multicenter, open-label extension study of safety and tolerability of lampalizumab~     administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who~     have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week~     treatment in Study GX29455 (NCT02288559).~   "
150084|NCT01601977|"~     COPD continues to be a cause of major morbidity for patients. Those patients who also have~     respiratory failure and obstructive sleep apnoea are at higher risk of exacerbations and~     death and have worse health related quality of life than similar COPD patients without~     respiratory failure.~      Treatment options in this group of patients have been limited and data to support the use of~     machines to assist breathing (non-invasive ventilators) in stable patients are limited. A~     major limitation of these devices has been patient acceptance and achieving sufficient~     control of sleep breathing disturbance.~      Currently devices are set at a fixed pressure to support the breathing throughout the night.~     The new software within the trial device will aim to better match the support provided by the~     machine to that needed by the patient. It is hoped that this may offer enhanced comfort as~     well as superior control of respiratory failure.~   "
150074|NCT01602107|"~     Urinary incontinence (UI) affects up to 50% of adult populations and stress urinary~     incontinence (SUI) is the most common form of UI, accounting for approximately 60% of~     patients. Women are affected by SUI much more often than men. Urine leakage in women with SUI~     occurs on exertion or during tasks that increase pressure on the bladder such as sneezing or~     coughing. SUI has been shown to be a barrier to physical activity in women, and as such can~     contribute to the development of diseases and disorders associated with inactivity.~      SUI appears to have many contributing factors such as structural damage (eg. tears in the~     pelvic organ supporting tissues), muscle weakness related to nerve injury or aging, or~     thinning of the urethral wall and/or its surrounding muscular sphincters. Currently the most~     common treatments for SUI are conservative therapy, which normally takes the form of exercise~     therapy provided by specialized nurses or physical therapists, and surgery, which is aimed at~     enhancing urethral support. Exercise therapy is effective, resulting in complete cure in 50%~     of cases, and surgery is effective for approximately 80% of patients but carries risks such~     as the development of urinary retention. It is currently not clear which treatment approach~     is better for which women.~      Through the proposed research, the investigators aim to determine how to predict which~     patients will improve or be cured with exercise therapy such that surgery can be avoided.~     Specifically the investigators will determine what is different between patients in whom~     exercise therapy succeeds and in whom exercise therapy fails. The investigators will also~     determine whether physiotherapist-supervised training of the pelvic floor muscles before~     surgery improves surgical outcomes. The proposed research will enable us to better understand~     the female continence system and how it responds to physiotherapeutic intervention. It will~     help us to develop improved assessment procedures that can streamline patient management.~   "
150075|NCT01602094|"~     Prevalence of participants who have protective immunity to measles virus is less than ninety~     percent.~      Predictor of adequate measles antibody levels include the following :~        -  History of measles infection~        -  History of complete measles primary immunization( 2 doses with at least 1 month interval~          after age of 9 months)~        -  History of measles exposure~      Predictor of inadequate measles antibody levels include the following :~        -  Born outside Thailand~        -  History of staying outside Thailand for long time in childhood~        -  Living in the rural area for a long period in childhood~        -  Fail to participate school system on time~   "
150076|NCT01602081|"~     The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of~     fistula closure in patients with persistent trans-sphincteric anal fistula who receive the~     Biodesign® Tissue graft as part of their LIFT procedure.~   "
150077|NCT01602068|"~     The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with~     dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery~     System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation~     of a posterior chamber intraocular lens.~   "
150078|NCT01602055|"~     The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets~     (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference~     product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd~   "
150079|NCT01602042|"~     The purpose of this study is to evaluate the utility of a portable motion sensor-based system~     designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms~     and expand care for ET patients.~   "
150080|NCT01602029|"~     Negative symptoms and cognitive deficits are two partially-related features of schizophrenia~     which have a major negative impact on social function and objective quality of life. Standard~     drug treatments have little impact on either and arguably no effect on primary negative~     symptoms. Social dysfunction has major economic consequences in both the developed and~     developing world. There is evidence that anti-inflammatory treatment may have beneficial~     effects in patients with schizophrenia.~   "
150081|NCT01602016|"~     Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking~     at the effects of Folinic Acid on language in Autism Spectrum Disorder and language~     impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment~     (there is no compensation for this visit). If language impairment is verified in the phase 1~     screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12~     weeks of folinic acid or an inactive placebo, in addition to several evaluations of your~     child's abilities and a single blood test. Children that complete phase 2 will be eligible~     for a 12 week open-label trial of folinic acid which is phase 3.~   "
150082|NCT01602003|"~     Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group~     study The study was divided into three parts: part 1 was a screening period started with an~     initial 2 weeks of exercise/diet program; part 2 was a double-blind treatment period during~     which eligible patients were randomized to Sitagliptin 100 mg qd (once daily), LC15-0444 25~     mg bid (twice daily), or LC15-0444 50 mg qd groups and received the assigned treatment for 24~     weeks; part 3 was for those patients who completed part 1 & 2 and consented to receive~     another 28 weeks of treatment with LC15-0444 50 mg qd.~      Screening tests were performed on the patients who had given the written informed consent.~     After 2-week exercise/diet program according to the generally recognized guideline, eligible~     patients were assigned one of three treatment groups with 1:1:1 ratio. During the total of~     24-week treatment period of part 2, each patient visited the study site at Week 6, 12, 18,~     and 24. Completing double-blind treatment for 24 weeks, each patient was asked to provide~     consent to participate in the part 3 of the study where all the patients were to receive~     LC15-0444 50 mg once daily. During 28-week treatment period of the part 3, each patient~     visited the study~   "
150083|NCT01601990|"~     Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group~     study The study was divided into three parts: part 1 was started with an initial 2 weeks of~     exercise/diet program followed by another 2 weeks of single-blind placebo run-in period; part~     2 was a double-blind treatment period during which eligible patients were randomized to~     LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks; part 3 was~     for those patients who completed part 1 & 2 and consented to receive another 28 weeks of~     treatment with LC15-0444 50mg. Screening tests were performed on the patients who had given~     the written informed consent. After 2-week exercise/diet program according to the generally~     recognized guideline, patients took placebo for another 2 weeks while continuing~     exercise/diet program. When the 2-week placebo run-in period was completed, eligible patients~     were assigned either to placebo or 50 mg of LC15-0444 with 1:1 ratio. During the total of 24-~     week treatment period of part 2 after randomization, each patient visited the investigational~     site at Week 6, 12, 18, and 24. Completing treatment with placebo or LC15-0444 50mg for 24~     weeks after randomization, each patient was asked to provide consent to participate in the~     part 3 of the study where all the patients were to receive LC15-0444 50mg regardless of the~     treatment received during the part 2 of the study. During 28-week treatment period of the~     part 3, each patient visited the investigational site at Week 30, 38, 46, and 52. Total study~     period from screening was 56 weeks per each patient.~   "
150086|NCT01601951|"~     The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the~     treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells~     that has been shown to have regenerative properties. This study is designed to evaluate the~     short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.~      Inclusion Criteria:~        -  Subjects must be scheduled for an autologous bone marrow hip or knee injection~        -  Subjects must have a diagnosis of hip or knee osteoarthritis~        -  Subjects must be between the ages of 18 and 85~        -  Subjects must be willing and able to sign Informed Consent~        -  Subjects must be willing and able to return for scheduled follow-up evaluations~      Exclusion Criteria:~        -  Subjects who have had any type of visco-supplementation in the treated joint within the~          last three months prior to enrollment~        -  Subjects for whom baseline data is not available~   "
150087|NCT01601938|"~     This study will be performed to determine whether selenium replacement reduces 28-day~     mortality of severe sepsis and septic shock patients, and to investigate whether selenium~     replacement contributes differently to the mortality reduction of the patients according to~     their initial serum selenium level.~   "
150088|NCT01601925|"~     Stellate ganglion block targets are C6 transverse process or C7 transverse process in~     anterior paratracheal approach which is most popular method. Cricoid cartilage is known that~     it is located at C6 level in supine neutral position of the neck. But stellate ganglion block~     is performed in supine extended position of the neck. So cricoid cartilage will move up to~     cephalad direction and pain doctors should find C6 or C7 transverse process at lower neck~     area than cricoid cartilage.~   "
150089|NCT01601912|"~     The primary study aim is to unravel the nature of impaired pain inhibition during exercise in~     patients with chronic Whiplash-Associated Disorders (WAD). This will be ascertained by~     examining whether activation of serotonergic and/or noradrenergic descending pathways~     improves pain inhibition during exercise in these patients. In addition, it is aimed at~     examining whether activation of serotonergic and/or noradrenergic descending pathways~     prevents post-exertional malaise following submaximal exercise in chronic WAD patients. A~     secondary study aim comprises of examining the effect of an acute submaximal exercise with~     and without activation of serotonergic or noradrenergic descending pathways on chronic WAD~     patients' cognitive performance. Furthermore, the isolated effect of activated serotonergic~     and noradrenergic descending pathways on chronic WAD patients' cognitive performance will be~     studied.~   "
150090|NCT01601899|"~     Even with the benefits of HIV therapy, there is a possibility that HIV-infected individuals~     develop metabolic complications once they initiate treatment, which may also ultimately put~     them at a risk for impending heart disease in the next decades.~      The main mechanism through which the main HIV drugs are thought to cause these metabolic~     changes and organ toxicities is mitochondrial toxicity. Most of studies that have been done,~     have taken place in the West, but few, if any, have been done in South Africa.~      The purpose of this study is to prospectively identify early changes between the two~     different drugs, Stavudine and Tenofovir, to assess their virological response, molecular,~     biochemical and clinical picture, and the possible associated change in cardiovascular risk~     factors, this, in the South African setting, and make recommendations to modify the current~     National AIDS role out programme~   "
150091|NCT01601886|"~     This study was designed to analyze whether initiation of the NICHD Neonatal Research Network~     SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery~     room in non-participants and whether these changes were associated with changes in management~     and outcomes.~      The investigators hypothesized that the investigators would observe following the initiation~     of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among~     non-participants preterm infants at Parkland Memorial Hospital.~   "
150092|NCT01601873|"~     The purpose for this study is to evaluate the patency and outcomes of conventional and~     heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.~   "
150093|NCT01601860|"~     Although there are studies that investigated the use of non-pharmacological pain relief and~     correction of dystocia during labor, there are few randomized controlled trials, especially~     related to combined protocols that use such resources. The use of combined protocols could~     potentiate the effects of resource use alone, evidencing the need for more studies related to~     the topic, as well as the effects of these methods on maternal and perinatal outcomes. In~     order to verify the effect of these methods in various stages of labor, childbirth and~     immediately becomes necessary to conduct a randomized controlled trial well-designed and~     adequate sample size that can make the future systematic reviews that can definitely conclude~     about the potential effectiveness of protocols that use combined resources to~     non-pharmacological pain relief in labor. Aim of our study is to evaluate the effects of a~     protocol of non-pharmacological resources on pain of pregnant women in the active phase of~     cervical dilatation and compared with controls.~   "
150094|NCT01601847|"~     The goal of this study is to identify a vitamin D supplementation strategy that best promotes~     the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational~     age). This is a high risk population that seems to have unique vitamin D needs, and~     inappropriate supplementation may promote wheezing or allergy. The results of this study will~     help form nutritional recommendations for the approximately 100,000 black infants born at~     30-36 weeks gestational age in the U.S. every year.~   "
150095|NCT01601834|"~     The purpose of this study in healthy people is to evaluate safety, toleration and time course~     of plasma concentration of single oral doses of PF-06273340. The effect of food on the~     Pharmacokinetic of PF-06273340 may also be investigated.~   "
150096|NCT01601821|"~     To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) +~     corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the~     introduction of MMF in de novo renal allograft recipients.~   "
150097|NCT01601808|"~     ViP is a double blinded clinical trial which will compare gemcitabine and vandetanib~     chemotherapy with gemcitabine alone in patients with locally advanced or metastatic~     pancreatic carcinoma.~   "
150251|NCT01599806|"~     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to~     Doripenem for treating hospitalized patients with complicated urinary tract infections,~     including acute pyelonephritis~   "
172213|NCT01311037|"~     The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal~     Women with Advanced Breast Cancer A Prospective Trial.~   "
150098|NCT01601795|"~     The use of volatile anesthetics in cardiac anesthesia is very common, because of their~     cardioprotective effects and their ability to ensure a sufficient depth of anesthesia. In~     line with the development of fast track concepts in cardiac anesthesia, volatile anesthetics~     are widely used to avoid a delayed recovery from cardiac surgery and anesthesia. Volatile~     anesthetics are delivered from calibrated vaporizers in the anesthesia machine or the~     cardiopulmonary bypass machine (during extracorporeal circulation).~      Isoflurane and Sevoflurane are the most commonly used volatile anesthetics in patients~     undergoing cardiopulmonary bypass (CPB). The vaporizer of the anesthetics is on the~     cardiopulmonary bypass machine and the volatile agent is blended with air and oxygen. Until~     now, the pharmacokinetics of halothane, enflurane, isoflurane and desflurane during CPB have~     been described.~      Sevoflurane might be of advantage because of additional myocardial protective effects during~     cardiac anesthesia and cardiopulmonary bypass. However, the pharmacokinetics of sevoflurane~     during CPB have not been investigated so far, although its being used at many hospitals.~      The investigators will conduct a randomized prospective study with either sevoflurane or~     isoflurane during cardiopulmonary bypass surgery. The study will help to answer the questions~     about the possible cardioprotective effects of the widely used volatile anesthetics and the~     hemodynamic stability during cardiopulmonary bypass. Knowing the pharmacokinetics of these~     drugs allows the anesthesiologist to titrate the volatile anesthetics more precise.~      The investigators hypothesizes that the maximal postoperative increase in troponin T will be~     smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes~     that the total amount of noradrenaline needed during the entire period of cardiopulmonary~     bypass will be smaller in the sevoflurane group than in the isoflurane group. The~     investigators hypothesizes that kinetics of washin and washout at the CPB will be faster in~     the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the~     time to extubation, respectively the length of stay in intensive care unit and hospital is~     shorter in the sevoflurane group than in the isoflurane group.~   "
150099|NCT01601782|"~     Determine if volume imaging can diagnose bone, ligament, muscle injuries.~   "
150100|NCT01601769|"~     Object of the study is the evaluation of the use of a rigid laparoscope for the diagnosis and~     therapy of lesions of the female genital tract as a substitution or a complementary method to~     colposcopy with the development of new standards for a tissue sparing therapy Use of existing~     laparoscopic instruments, which allow a better quality level in the diagnosis and therapy~     than the current routine.~      Development of new optics and instruments, which allow a tissue sparing approach Pre and~     postoperative measurement of the cervical volume, to be sure that the tissue removal is kept~     to a minimum level Development of qualitaty parameters for the most tissue respecting~     operations of the uterine cervix Prospective evaluation of the influence of tissue sparing~     surgery on future pregnancies~   "
150101|NCT01601756|"~     Hypothesis: navigated revision total knee arthroplasty results in a more precise~     reconstruction of preoperatively planned joint line than conventional revision total knee~     arthroplasty (rTKA).~   "
150102|NCT01601743|"~     The purpose of this study is to test the effects of exercise on cocaine use, fitness, and~     cravings for cocaine and nicotine. This study is part of an effort to develop treatments for~     cocaine abuse.~   "
150103|NCT01601730|"~     The purpose of this study is to improve the efficacy of modafinil as a potential treatment~     for cocaine dependence.~   "
150104|NCT01601717|"~     The purpose of this study is to evaluate the safety and efficacy of RTI-336 as a treatment~     for methamphetamine (METH) dependence in non-treatment-seeking METH-dependent volunteers.~   "
150105|NCT01601704|"~     The purpose of this study is to determine the effects of NB relative to placebo on major~     adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial~     infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of~     having these events because they have diabetes and/or other cardiovascular risk factors.~   "
150106|NCT01601691|"~     The purpose of this study is to evaluate the usefulness of diluted DuraSeal product as a~     spacer between prostate and rectum in prostate cancer low dose brachytherapy.~   "
150107|NCT01601678|"~     The aim of this study is to compare short and long-term feasibility, safety and efficacy of~     endoscopic (POEM) with laparoscopic myotomy (Heller myotomy) in the treatment of achalasia.~   "
150108|NCT01601665|"~     The purpose of this study is to evaluate the use of toric high cylinder power intraocular~     lenses in a larger population in clinical practice and assure the continued safety of these~     approved devices.~   "
150109|NCT01601652|"~     The study will evaluate the safety and efficacy of an intravenous fish oil emulsion~     (omegaven) in infants with parenteral nutrition associated cholestasis.~   "
150110|NCT01601639|"~     The investigators goal is to compare the standard argon plasma coagulation (APC) treatment~     with endoscopic band ligation (EBL) in patients with Gastric Antral Vascular Ectasia.~   "
150111|NCT01601626|"~     There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment~     regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor~     (PI)-based antiretroviral therapy (ART). This study compared three alternative co-treatment~     options among participants in high TB endemic resource-constrained settings, in which one~     co-treatment option explores if an additional anti-HIV drug needs to be used when patients~     are being treated with a PI together with rifabutin-based anti-TB treatment.~   "
150112|NCT01601613|"~     This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of~     activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with~     Dengue haemorrhagic fever (DHF).~   "
150113|NCT01601600|"~     The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal~     muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly~     adults with sarcopenia and mobility limitations. In addition, this study will generate data~     on the safety, tolerability, and pharmacokinetics of BYM338 in older adults and its response~     on additional physical function measures in this population. Furthermore, the extended study~     duration will provide information on the stability of BYM-induced changes in skeletal muscle~     and patient function in this subgroup of the older population.~   "
150125|NCT01601444|"~     Early detection of pleural effusion (PLE) would improve the treatment. However, preclinical~     detection of pleural effusion is often not possible.~      Radiographic examination, widely used for detecting pleural effusion ,is not suitable for~     prolonged monitoring of patients at high risk of developing PLE especially ambulatory or at~     home The currently available methods for monitoring and early detection such as the~     measurement of pulmonary capillary wedge pressure or measurement by double indicator~     thermodilution, are not reliable enough and may themselves lead to complications.~      Measuring internal thoracic impedance (ITI), the main component of which is lung impedance,~     is a noninvasive and safe method. PLE will be diagnosed in accordance with well-accepted~     clinical signs(dyspnea, cyanosis, pulmonary rales, crepitations, arterial hypoxemia) and~     roentgenological criteria~   "
150126|NCT01601431|"~     This is a research study about the usefulness of transparent cap during screening~     colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the~     tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will~     improve the detection of adenomatous polyps (polyps which can become colon cancer later on)~     in comparison to the standard colonoscopy.~   "
150114|NCT01601587|"~     Patient participation (PP) in Hospital is a goal defined by the Norwegian Health Authorities~     and it is a mandatory activity for District Psychiatric out-patient Centres (DPC) in Norway:~     patients are entitled to have influence on their treatment and should receive sufficient~     information directed at empowerment. Nevertheless, studies from Norway have found that~     patients who seek help are dissatisfied with the information they receive and doubt their~     possibility for real influence on their treatment. One way to improve individual PP might be~     to give patients sufficient information and education before they start their treatment in~     the form of an educational group intervention, an introduction seminar (IS); this group~     intervention is less time and resource consuming than individual interventions.~      Aims: The main purpose of this project is to develop and evaluate an IS for patients on a~     waiting list of DPC. The seminar will educate patients, so they can actively participate in~     their own treatment and, thereby, choosing treatment, reducing the risk of dropping out of~     treatment. Another aim is to enable patients to participate in their own treatment, to cope~     with their problems while they are waiting for treatment by providing them contact with~     primary health care and user organizations during their waiting time, and to increase~     adherence.~      Methods: The project involves three components: an exploratory study of educational content~     of the seminar; RCT of that 4-hours program (to examine its effect on treatment preferences~     and choices, activation, satisfaction, mental health and cost-benefit) and then a~     post-seminar qualitative evaluation, which will be used to create a broad yet deep~     understanding of the practical side of the participants`experience and the seminar's effect.~   "
150115|NCT01601574|"~     The purpose of this study is to determine whether the Weight Watchers program modified for~     use by people with Type 2 diabetes results in more improvements in blood glucose control~     relative to a control group receiving standard diabetes counseling.~   "
150116|NCT01601561|"~     Background: The hyperinsulinemic-normoglycaemic clamp technique is a precise method of~     providing insulin and glucose while maintaining normoglycemia. High-dose insulin has profound~     effects on glucose and protein metabolism. It has been demonstrated in coronary artery bypass~     graft (CABG) surgery patients that high-dose insulin causes hypoaminoacidaemia. The~     investigators hypothesize that the reduction of plasma amino acids (AAs) levels as seen in~     patients undergoing CABG surgery and receiving high-dose insulin is a consequence of an~     inhibition of whole body proteolysis as assessed by L-[1-13C]leucine tracer kinetics.~      Objective: The present study aims to investigate the effect of high-dose insulin therapy on~     whole body protein, glucose and end-organ metabolism in patients undergoing CABG surgery~     using stable isotope tracers [6,6-2H2]glucose, L-[1-13C]-leucine and L-[2H5]phenylalanine.~     The changes in the metabolic-endocrine milieu will also be evaluated by plasma concentrations~     of glucose, lactate, free fatty acids, prealbumin, albumin, fibrinogen, insulin, glucagon,~     and cortisol.~      Methods: With the approval of local institution's ethical committee, 30 patients scheduled~     for elective will be enrolled. The patients will be divided randomly into two groups. The~     control group will receive a standard IV insulin protocol with the aim of keeping blood~     glucose < 10 mmol/L. The treatment group will be administered a high dose insulin infusion of~     5 mU/kg/min coupled with a variable infusion of glucose to maintain normoglycemia (4-6~     mmol/L). Insulin infusion will be continued until the end of the study period approximately 8~     hours after surgery. L-[1-13C]leucine and [6,6-2H2]glucose kinetics will be used to assess~     changes in whole body protein and glucose kinetics. Hepatic albumin synthesis will be~     determined by using primed continuous infusion of L-[2H5]phenylalanine. The preoperative~     measurements will be performed on the morning before the surgery. Postoperative studies will~     be conducted two hours after arrival in the intensive care unit. Tracer kinetics between the~     two groups will be analyzed using ANOVA for repeated measurements.~      Significance: High-dose-insulin results in a significant reduction in plasma AAs in cardiac~     surgery. This study should address if this drop in plasma AA levels is secondary to a~     decrease in breakdown, an increase in synthesis or both during high-dose insulin therapy in~     open heart surgery.~   "
150117|NCT01601548|"~     Upon the completion of aggressive chemotherapy and radiation for curative intent cancers,~     many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as~     hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety.~     Mindfulness Based Cancer Recovery (MBCR) is a type of mind-body intervention. Mind-body~     interventions are defined as practices or interventions that focus on the connection and~     integration of the mind and body and the ability for these connections to effect changes on~     physical, emotional and spiritual levels for the purpose of promoting health and well being.~   "
150118|NCT01601535|"~     The goal of the first part of this clinical trial (Phase I portion) is to study the side~     effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to~     standard chemotherapy drugs, irinotecan and temozolomide.~      The goal of the second part of this clinical trial (Phase II portion) is to learn how many~     children and young adults show improvements in their neuroblastoma when treated with the~     combination of MLN8237, irinotecan, and temozolomide.~   "
150119|NCT01601522|"~     The purpose of the study is to determine how a type of treatment for peanut allergy known as~     oral desensitization works in the immune system.~   "
150120|NCT01601509|"~     Nasal resistance presents considerable variations during night[8]. Additionally, Oral and~     oro-nasal breathing epochs exhibit strong correlation with the number of apnoea/hypopnoeas~     [7].The hypothesis that the present study aims to test is whether the pharmacological~     prevention of increased nasal resistance during night could alter breathing route pattern and~     lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal~     resistance.~   "
150121|NCT01601496|"~     The purpose of the study is to evaluate the safety and efficacy of the the FUSION™ Vascular~     Graft.~   "
150122|NCT01601483|"~     This is a Phase II/III vehicle controlled, double masked, single center study. A single eye~     of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD)~     will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2~     years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for~     these patients.~      An analysis of the primary and secondary endpoints will be conducted when all subjects have~     completed 12, 18 and 24 months.~   "
150123|NCT01601470|"~     This study was conducted to investigate the potential for a pharmacokinetic drug-drug~     interaction in support of the co-administration of LCZ696 and sildenafil.~   "
150124|NCT01601457|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of~     activated recombinant human factor VIIgiven in conjunction with standard therapy in patients~     undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular~     fractures.~   "
150127|NCT01601418|"~     The objective of the study was to assess the effect of a range of single oral doses of YF476~     on pentagastrin-induced gastric acid output in healthy volunteers~   "
150128|NCT01601405|"~     The objectives of the study were:~        1. To show that a single dose of YF476 blocks gastrin receptors in healthy subjects~        2. To show that YF476 retains its ability to block gastrin receptors after repeated dosing~          despite losing its ability to suppress gastric acidity.~   "
150129|NCT01601392|"~     The purpose of this study will to compare the long-term effect of anodal versus cathodal~     transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients.~     Forty patients with subacute ischemic stroke will randomly assigned to one of three groups:~     Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes~     daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor~     cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS),~     the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at~     baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical~     excitability will be measured at baseline and after the 6th session in both hemispheres.~   "
150130|NCT01601379|"~     The purpose of this observational study (this means that no drug is being tested in this~     study) is to obtain updated and detailed information about the Gastroesophageal Reflux~     Disease (GERD) specificities in European patients. The information about patients suffering~     from typical GERD symptoms will be collected in order to establish a classification of adult~     patients profile based on the characteristics of GERD symptoms. This study will only involve~     data collection about the disease. The treatment will not be affected by the study.~   "
150131|NCT01601366|"~     Adenomyosis is a disease entity diagnosed when endometrial glands and stroma deep in the~     myometrium are associated with surrounding myometrial hypertrophy. The finding classically~     associated with adenomyosis is excessive uterine bleeding accompanied by worsening~     dysmenorrhea. The advent of endovaginal US has substantially improved the ability to diagnose~     adenomyosis. Different US features of adenomyosis have been reported, including uterine~     enlargement not explainable by the presence of leiomyomas, asymmetric thickening of the~     anterior or posterior myometrial wall, lack of contour abnormality or mass effect,~     heterogeneous poorly circumscribed areas within the myometrium, anechoic lacunae or cysts of~     varying sizes, and increased echotexture of the myometrium.~      Transvaginal power Doppler application is useful in studying the vascular tree of adenomyosis~     and can aid clinicians in planning the most appropriate therapeutic strategy. The~     differential diagnosis using power Doppler sonography is based on vascular characteristics.~     Adenomyosis is characterized by a preserved vascular texture supply that results in dilated~     spiral arteries running perpendicular toward the myometrium into the endometrial surface.~     Leiomyomata exhibits a vascular tree that typically circumscribes the solid mass. 2D~     transvaginal power Doppler angiography should be used to improve diagnostic sensitivity and~     facilitate appropriate therapeutic intervention.~      The levonorgestrel-releasing intrauterine system (IUS), Mirena, has been approved in Europe~     for contraception since 1990. Because of the suppressive effect of levonorgestrel on the~     endometrium, Mirena has also been proven to be effective for the management of menorrhagia~     and dysmenorrhea, and as a progestin component in postmenopausal hormone therapy. It was~     introduced in Taiwan in 1995 as an alternative therapy for idiopathic menorrhagia. Many cases~     of menorrhagia are caused by adenomyosis, and Mirena was, therefore, introduced for the~     treatment of adenomyosis in Taiwan.~      The current study is designed to evaluate the best treatment modality for treatment of~     adenomyosis clinical by assessment of dysmenorrhea and or chronic pelvic pain by visual~     analogue scale and menstrual blood loss by menstrual diary, imaging by ultrasound and Doppler~     indices.~   "
150132|NCT01601353|"~     The purpose of this study is to evaluate the safety and efficacy of adipose derived cells for~     the treatment of erectile dysfunction symptoms.~   "
150133|NCT01601340|"~     The purpose of this study is to evaluate the effects of HQK-1001 on Hb F in subjects with~     sickle cell disease.~   "
150134|NCT01601327|"~     The aim of the present study was to demonstrate the influences of three different treatment~     strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic~     hypogonadotropic hypogonadism (IHH).~   "
150135|NCT01601314|"~     The purpose of this study is to determine the relationship between magnesium sulphate~     administration and levels of S100B protein in serum of patients undergoing supratentorial~     brain parenchymal resection.~   "
150136|NCT01601301|"~     The purpose of this study is to obtain post market performance and safety data of the Ellipse~     PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb~     lengthening.~   "
150137|NCT01601288|"~     The purpose of this study is to create a prospective database of all patients who have~     undergone pulmonary function testing from which the investigators can study the clinical~     phenotypes of various respiratory conditions. The investigators hope by understanding the~     differences in these myriad phenotypes to be able to provide individualized, patient-targeted~     therapy in the future.~   "
150138|NCT01601275|"~     Prospective data collection of all patients with microbiologically proven mycobacteria~     tuberculosis infection treated at Singapore General Hospital.~   "
150139|NCT01601262|"~     Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of~     new blood vessels. The investigators hypothesized that LISW therapy could improve the~     symptoms of patients with erectile dysfunction resulting from a problem of blood supply who~     respond to oral therapy (PDE-5 inhibitors). The current study will check the Efficacy and~     Safety of a Second Series of LISW Treatment for Erectile Dysfunction Patients Who Were~     Partial Responders to the Initial Treatment.~   "
150140|NCT01601249|"~     Selecting one or two IVF embryos with the highest potential to implant is extremely important~     for the success of the treatment- obtaining pregnancies and avoiding multi-fetal gestations.~     The currently used IVF embryo grading method is based solely on embryo morphology (cleavage~     rate and fragmentation) just before the transfer, which is not very well correlated with the~     implantation potential of each embryo. Oocyte quality and adequacy are the most important~     factors determining the biological quality and implantation potential of the embryo. It~     impossible to grade oocytes using plain optical systems, other than maturity and gross~     anomalies.~      Polscope systems allow to visualize intra ooplasmic structures and determine their~     retardance, as well as that of the Zona Pellucida. The investigators hypothesize that grading~     embryos using the oocyte's parameters as visualized by polscope is superior to conventional~     morphology and correlates better with their implantation potential.~      Here the investigators will perform a prospective randomized controlled trial to examine this~     hypothesis.~   "
150154|NCT01601067|"~     Comorbidity of alcohol use disorder (AD) and posttraumatic stress disorder (PTSD) is common.~     Currently available treatments often do not lead to sustained recovery from these disorders,~     possibly because they typically do not include exposure therapy which is considered best~     practice treatments for PTSD. This study compares exposure-based integrated treatment to~     integrated coping skills psychotherapy (a well disseminated practice) for comorbid AD and~     PTSD with the hypothesis that exposure therapy will allow those with PTSD to better sustain~     PTSD symptom reduction and reduction in alcohol use. The aim of this grant is to change~     common treatment practices for comorbid AD and PTSD by increasing the availability of~     evidence-based PTSD treatment for those with AD.~   "
150283|NCT01599390|"~     The study will assess the burden of severe influenza outcomes by age, risk status, and~     influenza subtype, in order to create a profile of the burden of influenza-related morbidity~     and mortality in United States from July 1997 to April 2009.~   "
150141|NCT01601236|"~     This Phase 2A study is an adaptive design pilot study investigating the efficacy and safety~     of daily Acthar administration in diabetic patients with nephropathy and proteinuria.~     Patients with type 1 diabetes mellitus (T1DM) or T2DM who currently take insulin will be~     enrolled and randomized into 6 study groups and will be treated with either Acthar or Placebo~     for 36 weeks, followed by a 4 week dose taper, and a 12 week observation period. The study~     will compare three dose regimens of Acthar (8 U [0.1 mL], 16 U [0.2 mL], and 32 U [0.4 mL])~     to equivalent volumes of Placebo to ensure the double-blind nature of the study.~      Insulin-requiring patients are being enrolled to aid compliance with the daily SC~     administration of study medication and to allow for ease of blood glucose control by~     adjustment of current insulin therapy in the event of glycemic excursions. Routine safety~     measures, including glycemic control, will be monitored throughout the study. The adaptive~     design component of the study allows for the re-assignment of the high dose group to the mid~     dose group if unacceptable toxicity is noted as per study protocol in the high dose group.~     Efficacy will be assessed by monitoring serum creatinine, calculated eGFR, and proteinuria~     (via urinary protein to creatinine ratio [PCR]). Serum cortisol concentration and additional~     biomarkers in blood and urine will also be monitored.~   "
150142|NCT01601223|"~     Objectives~        1. To characterize mechanical ventilation practices during general anesthesia for surgery~        2. To assess the dependence of intra-operative and post-operative pulmonary complications~          on intra-operative Mechanical Ventilation (MV) settings~   "
150143|NCT01601210|"~     The purpose of this study is to see if creatine, which is a naturally occurring chemical in~     the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.~      The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate~     for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr)~     concentrations.~   "
150144|NCT01601197|"~     Immunization injections are a significant source of pain for infants. Tactile stimulation~     (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it~     is cost neutral, and has been shown to be effective in children and adults undergoing~     injections. The aim of this study is to determine the added benefit of tactile stimulation~     when added to other proven analgesic interventions during routine infant immunization~     injections.~   "
150145|NCT01601184|"~     The purpose of this study is to evaluate the safety of vismodegib in combination with~     temozolomide (primary objective - phase I) and to estimate the efficacy of vismodegib in~     combination with temozolomide in adult patients with recurrent, progressive, or refractory~     medulloblastomas to standard therapy measured by the 6-month progression-free rate (phase~     II).~      This study is an open-label Phase I/II, international, randomized.~      38 patients will be included in the study.~   "
150146|NCT01601171|"~     The purpose of this study is to explore the genetic basis of reproductive disorders.~   "
150147|NCT01601158|"~     This open-label study aims to evaluate the safety and efficacy of umbilical cord blood~     therapy for children with global developmental delay.~   "
150148|NCT01601145|"~     The aim of the present research protocol was to evaluate the effect of probiotics daily used,~     on the plaque acidogenicity of children. The null hypothesis was that the plaque~     acidogenicity would remain unchanged and not associate with the use of probiotics. Moreover,~     the in situ study will be carried out to investigate the plaque formation as biofilm in~     demineralised enamel specimens following the regular consumption of a probiotic product~     compared to a control group. Metabolic of the biofilm formed on of the enamel specimens~     resulting from the consumption will be evaluated over a period of 8 weeks.~   "
150149|NCT01601132|"~     Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe~     substrate. When the two are co-administered the potential exists for a clinically significant~     drug interaction. This study aims to determine the effect of steady-state colchicine on the~     pharmacokinetics of theophylline administered as a single dose. A secondary goal is to~     evaluate the safety and tolerability of this regimen in healthy volunteers. All study~     subjects will be monitored for adverse events throughout the entire study period.~   "
150150|NCT01601119|"~     The objective is to establish the impact of current disease modifying therapies (DMTs) and~     associated support services on Patient Reported Experience Measures and Patient Reported~     Outcomes in relation to the treatment and management of Relapsing Multiple Sclerosis in the~     United Kingdom (UK).~   "
150151|NCT01601106|"~     Cardiovascular disease(CVD) is the leading cause of morbidity and mortality in developed~     nations. CVD is primarily caused by atherosclerosis, a systemic disease characterized by~     lipid deposition in the subendothelial space with a concomitant, low-grade inflammatory~     reaction.(Fuster, Moreno et al. 2005) To date, most therapeutic interventions aimed at~     lowering CVD have thus far focused on modulating lipid levels, either lowering LDLc or~     increasing HDLc levels. Yet, since the introduction of statins 20 years ago, there have been~     few breakthroughs in the treatment of this disease. A promising strategy to reduce CVD is to~     directly target inflammation at the level of the vessel wall.(van Leuven, van Wijk et al.;~     Libby 2002) A potential drawback of anti-inflammatory strategies pertains to the thin line~     between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression.~     Therefore, continuous low dosed anti-inflammatory drugs have great potential as novel~     treatment strategies. In the present project, the investigators propose to inject liposomal~     glucocorticoids intravenously in patients with an increased risk of atherosclerotic disease~     aiming to reduce vessel wall inflammation.~   "
150152|NCT01601093|"~     In the proposed study, the investigators plan to evaluate the efficacy and safety of~     Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory~     and urinary tract acute bacterial infection.~   "
150153|NCT01601080|"~     This is an observational, retrospective, UK & Ireland audit measuring patient adherence to~     Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple~     Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™~     device for injection for a minimum of 24 months.~   "
150205|NCT01600404|"~     Prospective evaluation of the cognitive function of in-house patients suffering from an acute~     traumatic spinal cord injury before and three months after the initiation of antimuscarinic~     treatment.~      The following hypothesis will be tested: Antimuscarinic treatment results in significantly~     worse cognitive test results three months after traumatic spinal cord injury compared to the~     pre-treatment results and the results of the control group.~   "
150155|NCT01601054|"~     Within the last decade there has been an increase in the number of surgical procedures for~     deformities of the spine. This is caused by the increase in the elderly population, improved~     surgical techniques and an increased number of patients who have undergone previous surgical~     treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities~     bears a revision rate between 15 and 30% depending on definition, and one of the primary~     reasons for revision surgery is implant loosening in the lumbosacral region.~      The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar~     spine in addition to the usual posterior instrumentation can reduce the revision rate with~     50%.~   "
150156|NCT01601041|"~     The purpose of this prospective study is to investigate the association between the amount of~     residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent~     (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year)~     spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing~     intermittent catheterization.~      The following hypotheses will be tested:~        1. The amount of residual urine after intermittent catheterization is significantly greater~          in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to~          those without.~        2. The incidence of asymptomatic bacterial prostate infections is significantly higher in~          SCI patients suffering from frequent (>2 /year) urinary tract infections compared to~          those without.~   "
150157|NCT01601028|"~     Primary Sjögren syndrome is one of the most prevalent autoimmune diseases that present with~     dry eye and dry mouth. But there is no proven effective treatment for Sjögren syndrome~     patient. The relation between toll-like receptor (TLR) and the pathogenesis of Sjögren~     syndrome has been reported. Hydroxychloroquine is TLR7 and TLR9 antagonist. A few studies~     have been reported the effectiveness of Hydroxychloroquine for Sjögren syndrome but no~     randomized controlled study has been done. So the investigators evaluate the effectiveness~     and safeness of Hydroxychloroquine for primary Sjögren syndrome by randomized controlled~     study (Hydroxychloroquine 300 mg once daily p.o. group (N = 30) versus placebo group (N =~     30).~   "
150158|NCT01601015|"~     Background. Tension-type headache (TTH) is the most common form of primary headache and it is~     a real problem for the subjects suffering from it. Until now, physiotherapy treatments have~     included different techniques combined together, without establishing which of them is more~     effective.~      Objective. The purpose of this study is to know the effectiveness of manipulative and manual~     therapy treatments, with regard to pain perception and neck mobility in patients with~     tension-type headache.~      Methods: A double-blind, randomized clinical trial was conducted, with 84 patients diagnosed~     with tension-type headache, divided into three treatment groups -manual therapy, manipulative~     therapy, and a combination of both techniques-, and a placebo control group. Four treatment~     sessions were administered during four weeks, with post-treatment assessment, and follow-up~     at one month. Cervical ranges of motion were assessed (CROM device), as well as pain~     perception (McGill Pain Questionnaire), and frequency and intensity of headaches (weekly~     register).~   "
150159|NCT01601002|"~     Patients with an episode of depression in late life prescribed mirtazapine recruited from a~     clinical sample will be monitored for weight and receive a blood test during their usual~     course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect~     weight gain.~   "
150160|NCT01600989|"~     Introduction: Evidence suggests that sepsis and septic shock severely impair mitochondria and~     that the resulting mitochondrial dysfunction is related to the severity and outcome of the~     resulting organ dysfunction. In sepsis mitochondrial abnormalities - biochemical and~     ultrastructural - have been recognized in multiple organs, including liver, kidney, skeletal~     and heart muscle tissue and blood cells. Circulating immune cells play an important role in~     the pathophysiology of sepsis. Stimulation of the immune system alters the energy~     requirements of immune cells; down-regulation of immune-cell activity has been associated~     with prolonged sepsis and unfavourable outcome. The aim of the project is to comprehensively~     investigate changes in mitochondrial function of immune cells in patients with severe sepsis~     and septic shock. The following main hypotheses will be evaluated:~        -  Severe sepsis and septic shock leads to increased energy requirements of immune cells~          and to an increase in mitochondrial enzyme activities and energy production.~        -  Changes of mitochondrial function in human immune cells are associated with alterations~          in clinical and laboratory markers of severity of sepsis.~        -  Prolonged sepsis and unfavourable outcome is associated with down regulation of~          mitochondrial function.~      Methods: A total of 30 adult patients admitted to the intensive care unit (ICU) due to severe~     sepsis or septic shock will be included in the study; 30 healthy volunteers serve as~     controls. Patients with any type of chronic infectious, inflammatory or autoimmune diseases,~     after transplantations or receiving immunosuppressive agents are excluded.~      Collected baseline characteristics include patient demographics, diagnosis and severity of~     illness scores at the time of admission. Daily collected follow up data include clinical and~     laboratory parameters of organ dysfunction, use of vasopressors/inotropes, use of~     antibiotics, use of steroids and results of microbiological cultures/stains.~      Negative identification and isolation of monocytes, B cells and CD4 T cells will be performed~     daily from ICU admission to discharge using an antibody-antigen mediated immunomagnetic cell~     isolation procedure that depletes all blood cells except the specific target cells.~     Mitochondrial function of immune cells will be assessed by measurement of mitochondrial~     complex activity for complexes I to IV by a standard titration protocol. Additionally, the~     levels of pro- and anti-inflammatory cytokines (Interleukin (IL)-1, IL-6, IL-10, TNF-α) will~     be assessed throughout the stay in the ICU. For comparison mitochondrial function of of~     monocytes, B cells and CD4 T cells and cytokine levels will be measured in a group of 10~     healthy volunteers.~      Analysis plan: Changes in mitochondrial function of immune cells over time compared to a~     healthy control group and during the course of severe sepsis and septic shock is the main~     outcome parameter of this study. Assessed predictors are determined by the severity of the~     underlying septic condition and include clinical and laboratory evidence for dysfunction of~     vital organ systems and changes in levels of inflammatory and anti-inflammatory cytokines.~   "
150161|NCT01600976|"~     The purpose of this study is to determine whether the pharmacokinetic (what the body does to~     the drug) parameters of telaprevir are altered in patients with moderate hepatic impairment,~     compared to the pharmacokinetic parameters in patients with normal liver function, and~     measure the relative unbound plasma concentrations of telaprevir.~   "
150162|NCT01600963|"~     The purpose of this study is to provide safety and efficacy data for TMC207 and to~     demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the~     BR plus placebo.~   "
150163|NCT01600950|"~     The study involves a single injection of LY2963016 and a single injection of Lantus, on 2~     separate occasions in participants with type I diabetes. Following each dose, participants~     will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7~     days between the two periods, during which time there will be no study treatment, but~     participants will resume their regular therapy. The duration of this study can be up to 9.5~     weeks. The purposes of this study are to understand how the blood sugar lowering effect of~     LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are~     metabolized by participants with type I diabetes.~   "
150284|NCT01599377|"~     The overall aim of the study is to establish bioequivalence between commercial tofacitinib~     tablet formulations with the tofacitinib capsule formulation.~   "
151866|NCT01578551|"~     To determine the 1 year progression-free survival (PFS) of the combination of metformin and~     standard chemotherapy in patients with previously untreated advanced or metastatic pulmonary~     adenocarcinoma.~   "
150164|NCT01600937|"~     Current guidelines recommend supervised mixed (aerobic+resistance) physical activity to~     ensure optimal benefits to control blood glucose, lipids, blood pressure, and other~     cardiovascular risk and to minimize injuries. However, these guidelines are difficult to put~     into action for a number of barriers and poor long-term patient compliance. This project will~     assess the effect of a behavioral intervention strategy on the promotion and maintenance of~     physical activity in type 2 diabetes.~   "
150165|NCT01600924|"~     This project will assess the independent predictors of impaired muscle and bone strength~     through a longitudinal observation of a cohort of subjects with type 1 and 2 diabetes~     consecutively attending an outpatients diabetes clinics for the annual screening of~     complications.~   "
150166|NCT01600911|"~     Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients~     and non-nutrients still remains to be discovered.We design a feeding study which provides~     plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The~     goal of this study is to establish a protocol for documenting metabolomics response to plant~     foods and try to characterize plant foods in terms of their anti-hypertension potentials with~     metabolomic profiling information.~   "
150167|NCT01600898|"~     In this prospective study, the investigators will implement a systematic screening program~     and 3-year follow-up in a cohort of asymptomatic BMPR2 mutation carriers. This study is~     designed to:~        -  determine predictive factors (biological, functional, radiological and hemodynamic) of~          development of PAH~        -  monitor these subjects' clinical, functional, biological, echocardiographic and~          hemodynamic characteristics~        -  assess the risk of occurrence of PAH~        -  screen patients with PAH at an early stage of disease and offer them an early management~        -  constitute a collection of biological samples (0, 12, 24 months follow-up) of~          asymptomatic BMPR2 mutation carriers.~   "
150168|NCT01600885|"~     The purpose of the study is~        1. To establish the feasibility of fMRI studies of the interaction of guanfacine and~          ketamine.~        2. To explore the possibility that guanfacine can ameliorate the negative effects of~          ketamine on task-related prefrontal activation.~        3. To assess the strength of any interaction between guanfacine and ketamine.~   "
150169|NCT01600872|"~     Both oxidative stress and Bisphenol A (BPA) had been associated with polycystic ovary~     syndrome (PCOS). BPA, one of endocrine-disrupting chemicals (EDCs), is an environmental~     estrogen used in the synthesis of plastics, is a high-volume production chemical with~     widespread human exposure. BPA was been reported in several female reproductive disturbance.~     However, the pathological pathway of BPA impact on female reproductive system had not been~     well-understood. Reactive oxygen species (ROS) have a role in the modulation of gamete~     quality and gamete interaction. Persistent and elevated generation of ROS leads to a~     disturbance of redox potential that in turn causes oxidative stress (OS). The first part of~     The investigators study is aim to evaluate the oxidative stress impact on the biochemical~     parameters in women with PCOS; the secondary part of the investigators study is to~     investigate the BPA on the clinical and biochemical of women with PCOS; finally, the~     investigators plan to test the hypothesis that BPA might increase oxidative stress and then~     elevated ROS in women with menstrual disturbance, furthermore, the role of oxidative stress~     and BPA impact on insulin resistance and metabolic disturbance will be also investigated.~      Study and control cases will be included. Serum total oxidant status (TOS), total antioxidant~     status (TAS), Bisphenol A (BPA), and clinical/biochemical parameters will be obtained for all~     cases. Oxidative stress and BPA will be evaluated with all clinical/biochemical parameters~     for all subjects.~   "
150170|NCT01600859|"~     Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild~     cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking~     thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor~     (AChEI) and/or memantine for AD must be on a stable dose for at least 12 weeks prior to~     Screening and remain on their stable dose throughout the trial. Subjects will receive placebo~     or a single oral dose of E2609. Safety assessments will be conducted. Additionally, the~     pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid~     biomarkers and cognitive and psychological measures.~   "
150171|NCT01600846|"~     The purpose of this study is to further integrate pharmacogenetic (PGx) testing into clinical~     practice by educating physicians about pharmacogenetics and offering testing to their~     patients. Pharmacogenetic testing may help physicians choose the best drug and dosage for~     their patients which can reduce side effects, increase effectiveness, and improve patient~     adherence.~      Two clinics will be involved. One clinic will have a pharmacist on-site as a resource to~     physicians and to advise what patients may benefit from PGx testing; the other clinic will~     have a pharmacist on call.~      Patient and physician perspectives about PGx testing and their utilization will be examined~     via surveys.~      The investigators hypothesize that with education about PGx testing, more physicians will~     utilize testing.~   "
150172|NCT01600833|"~     The purpose of this study is to study the association of serum ferritin and homocysteine~     levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome~     The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women~     with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term~     consequence of women with PCOS. Recent evidence suggests that increased body iron might be~     involved in the pathogenesis of insulin-resistance disorders, furthermore,~     hyperhomocysteinemia is associated with an increased risk of atherosclerotic and~     thromboembolic disorder. The investigators plan to retrospectively review the medical records~     of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical~     Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.~   "
150173|NCT01600820|"~     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable~     low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly~     hypercholesterolemic subjects treated or not by statins.~   "
150249|NCT01599832|"~     The purpose of this study is to find out what effects pazopanib (pazopanib hydrochloride)~     (also called Votrient®) may have on MRI (magnetic resonance imaging) scans, blood pressure,~     and various proteins in the blood. Pazopanib is Food and Drug Administration (FDA) approved~     for treating renal cell cancer. It is an agent that prevents angiogenesis, which is new blood~     vessel formation. The use of pazopanib described in this study is a standard of care, but the~     additional MRI and blood tests that will be performed are experimental~   "
150174|NCT01600807|"~     OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been~     used in other research studies and information from those suggests that OSI-906 may help~     block cell receptors involved in tumor growth.~      Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this~     research study, the investigators are looking for the highest dose of OSI-906 that can be~     given safely in combination with gemcitabine and erlotinib. This dose will then be given~     together with gemcitabine and erlotinib to a further group of patients with pancreatic~     cancer.~   "
150175|NCT01600794|"~     Because the society convention is changed, people are late for getting married, leading to~     increasing the bearing age in women. According to the previous study, if the age is over 30,~     the oocyte number in ovary has left only 10％ and 3％ in over 40 years old. The data is~     collected by Bureau of Health Promotion, Department of Health shows that there are about 7000~     people treating the infertility and it spends about 150000 to 250000 NT dollars in every in~     vitro fertilization (IVF) cycle, but the live birth rate is only 30％. So it is important to~     know how to estimate and approve the ovary function that lead to increase the live birth~     rate. The investigators plan to estimate the correlation between the serum androgens levels~     and pregnancy outcome in the women who have infertility problem. Furthermore, for the~     repeated IVF cycle, the ovary function might be re-evlauated because of the possible effect~     from stimulated drugs used on previous cycle. It's important to understand the ovary function~     for IVF patient to choose the appropriate drugs and dose.~      The investigators use blood and clinical test to analyze, the items for analysis are below:~        1. Routine blood test: FSH、LH、E2、P4、Anti-Mullerian Hormone(AMH)、~        2. Studied blood test: Inhibin B、total testosterone (TT)、Androstenedione、DHEA-S~        3. Clinical test: Ultrasound~        4. Personal condition. In order to finishing the test, every patient will be asked to~          collect about 10 to 15 cc blood for the research.~   "
150176|NCT01600781|"~     This is a randomised, controlled, open-label intervention study. It is hypothesized that~     supplementation with a fibre enriched sip feed will improve the nutritional status, gut~     microbiota and quality of life (QOL) of children with acute lymphoblastic leukemia, and may~     enhance their immune response. This could give them a better chance to finish their induction~     chemotherapy successfully with fewer side effects.~   "
150177|NCT01600768|"~     The purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of~     extended infusion of beta-lactams in intensive care patients who are infected with~     Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH).~   "
150178|NCT01600755|"~     The aim of this clinical study is to investigate the safety and feasibility of Autologous~     Muscle Derived Cells (AMDC; a preparation of a patient's own cells) injection into the anal~     sphincter for treatment of patients with fecal incontinence.~   "
150179|NCT01600742|"~     Vorinostat is a potent and well tolerated HDAC inhibitor. It has been reported to enhance~     radiosensitivity of cancer cells. We hypothesize that the addition of vorinostat to WBRT may~     increase therapeutic efficacy for patients with brain metastases.~   "
150180|NCT01600729|"~     This study will evaluate the inter-rater and intra-rater reliability of the Facial Wrinkle~     Scale with Asian Photonumeric Guide (FWS-A) in Japanese subjects.~   "
150181|NCT01600716|"~     This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the~     treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.~   "
150182|NCT01600703|"~     Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon~     like peptide 1) reduces intestinal production of lipoprotein particles. The investigators~     therefore hypothesise that the drug sitagliptin which prevents the breakdown of GLP-1 will~     reduce intestinal lipoprotein production in humans. The investigators are unable to speculate~     whether sitagliptin will affect hepatic lipoprotein production because of lack of of data~     from animal studies or in vitro data. Sitagliptin is already an approved treatment for type 2~     diabetes.~   "
150183|NCT01600690|"~     Statins are commonly prescribed to lower cardiovascular risk in primary and secondary~     prevention. Despite their well known efficacy, statin withdrawal is a common event. Even a~     short term statin withdrawal can have dramatic consequences on atherosclerotic plaque~     stability, owing to a rebound in cholesterol levels and inflammation.~      The effects of a short term statin withdrawal on endothelial progenitor cells (EPC) and~     monocyte/macrophage polarization is unknown.~      In this study, the investigators will explore the effects of a 5-day statin withdrawal on EPC~     and monocyte/macrophage polarization, together with other inflammatory biomarkers in type 2~     diabetic patients. The investigators hypothesize that statin withdrawal determines a~     reduction in EPC levels and an inflammatory cell polarization.~      Patients will be randomized to continue their habitual statin regimen or to withdraw statin.~     At baseline and 5 days later, blood samples will be collected for experimental measures.~   "
150184|NCT01600677|"~     The research study is a randomized controlled trial (RCT). The primary endpoint is to compare~     medication adherence of adult patients recently hospitalized with a diagnosis of common~     cardiac conditions who require medication assistance either by receiving usual care or by~     using a medication delivery unit. The overall study will last a total of 12 months. Each~     subject will be enrolled for a period of 90 days.~   "
150193|NCT01600560|"~     With the surge in use of electronic media among adolescents, a strategy that has been~     utilized to increase HPV4 uptake in girls has been reminder text messaging to their parents.~     To date, no published study has looked at the effectiveness of texting adolescents themselves~     (especially boys) rather than their parents OR compared texting to social network sites to~     increase HPV knowledge and uptake of HPV vaccination in boys. Interactive technology-based~     interventions targeted at youth are feasible in North Carolina for the following reasons: (1)~     through the NC Minors' Consent Law adolescents can consent to the prevention, diagnosis, and~     treatment of sexually transmitted diseases (N.C. Gen. Stat. § 90-21.5(a); and (2) many school~     based health centers can provide immunizations. Since HPV infection is a sexually transmitted~     infection, NC teens do not have to get consent for HPV prevention (i.e., vaccination).~      To optimize HPV vaccination in young people, especially males, communication strategies are~     needed to motivate adolescents to get themselves vaccinated. Texting has been demonstrated to~     be a feasible, popular, and effective method of sexual health promotion to young people with~     a relatively low withdrawal rate, positive feedback, and an observed improvement in sexual~     health knowledge and STI testing (12). Social media communication strategies are a new and~     potentially effective channel for communicating public health messages about HPV vaccine that~     are also likely to increase HPV initiation and completion among adolescent girls in addition~     to boys.~      According to the NC Immunization Registry, as of March 8, 2011, only 2% of boys ages 9-13 had~     received at least one dose of HPV vaccine. In the investigators continuity clinic less than~     50 percent of adolescents are fully immunized. This project will identify social behavioral,~     emotional, and cognitive correlates and predictors that help explain why teens pursue,~     complete, and do not complete HPV vaccination, and develop a social media communication~     intervention collaboratively with teens to increase HPV vaccine initiation and completion.~   "
150185|NCT01600664|"~     A randomized controlled study to evaluate the effect of 3 months use with interactive~     computer game- My Diabetic Friend- comparing to conventional diabetes education on~     metabolic control, quality of life and diabetes knowledge.Patients will be randomized into~     two groups- one group will be supplied with interactive computer game, My Diabetic friend,~     installed on a computer designed for children's educational needs for a period of three~     months and the other group will be supplied with the same computer without the interactive~     computer game for three months. Metabolic control, quality of life and diabetes knowledge~     will be evaluated before and after the use of the computer.~      The trial is consisting of two main periods: 3 months of the main study period and an~     optional extension period consisting of the following 3 months :~      The study will include two main periods;~        1. Period 1 which will last 3 months, in a randomized controlled manner, this period will~          serve as the main study period to assess the primary and secondary endpoints of the~          study.~        2. Period 2: this extension period will not be an integral part of the study, and only~          patients who are willing will take part at this period, will continue to participate at~          the optional extension period. During the extension period, patients in the intervention~          group will be offered to continue the use of the Computer game -My diabetic friend) for~          the following 3 months, and patients who participated at the control group during period~          1, will be offered to start to use the Computer Game - My Diabetic Friend for the~          following 3 months.~   "
150186|NCT01600651|"~     RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar~     epithelial type I cell injury, and soluble RAGE (sRAGE) is elevated in the plasma and in the~     pulmonary edema fluid from patients with ALI/ARDS. Few data are available about the influence~     of ventilatory interventions on levels of sRAGE in the setting of ALI/ARDS. The purpose of~     this prospective monocentric randomized controlled cross-over study is to describe the~     effects of a recruitment maneuver (RM) on plasma sRAGE levels during diffuse ARDS.~   "
150187|NCT01600638|"~     The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the~     CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with~     sharp body curvature.~   "
150188|NCT01600625|"~     One of the important factors in obtaining successful outcomes when treating severe meibomian~     gland dysfunction (MGD) is to control the existing ocular and eyelid inflammation. Thus, in~     previous studies, topical and systemic antibiotics with anti-inflammatory function, such as~     topical azithromycin, systemic tetracycline, doxycycline and minocycline, have been used to~     treat severe MGD. In this study, minocycline which had the fewest side effects was used to~     evaluate the effect on cytokine levels in severe MGD. At study initiation, all patients~     completed an Ocular Surface Disease Index (OSDI) questionnaire and had an ocular surface,~     tear, and meibomian gland evaluation that consisted of fluorescein tear break-up time (TBUT),~     Schirmer test, corneal and conjunctival fluorescein staining, microscopic examination of lid~     margins and meibomian glands, and tear cytokine levels. All measurements except tear cytokine~     levels were conducted in the same manner before treatment, after 1 month, and after 2 months~     of treatment. Tear cytokine levels were evaluated before treatment and after 2 months of~     treatment. The aim of this research was to determine the concentration of inflammatory~     cytokines in the tears of patients with MGD and to compare the cytokine levels, corresponding~     clinical responses, and ocular symptoms before and after 2 months of treatment with oral~     minocycline.~   "
150189|NCT01600612|"~     Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an~     estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of~     PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most~     conventional drug which was proved effective. However, it has the shortcomings of short half~     life and the necessity of intravenous administration. Misopristol, and more recently~     Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.~      Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin~     for treatment of atonic PPH.~   "
150190|NCT01600599|"~     The purpose of this study is to assess the efficacy of IV Tranexamic Acid and topical~     Tranexamic Acid to control post op bleeding following Coronary Artery Bypass Graft Surgery~     using Cardiopulmonary Bypass.~   "
150191|NCT01600586|"~     Neonatal intensive care unit infants are at high risk for oromotor difficulties including~     poor coordination of sucking swallowing and breathing. These feeding difficulties often~     result in prolonged hospitalization, with increased physiologic stressors and poor growth. In~     preliminary studies, Pacifier Activated Lullaby (PAL) use showed potential increased oromotor~     skills and decreased length of hospitalization.~      The investigators propose to test the hypothesis that a week-long PAL intervention can~     improve feeding skills and decrease stress compared to standard of care parental interactions~     in infants in the late preterm period. The investigators also hypothesize that these~     improvements will result in shorter hospital stays and increased growth in the intervention~     group.~      Our study design is a prospective randomized controlled trial design of 94 infants~     (Post-conceptional ages 34-36 weeks). The 47 intervention-group infant/mother dads will~     receive a book library with one lullaby book and record her voice to the PAL, which the music~     therapist will then administer in 15-minute sessions for 5 consecutive days. The 47~     participants in the control group will receive the same library but no recording will be made~     or PAL used. Outcomes measured will include time to full oral feeds, suck rate and~     efficiency, salivary cortisol levels before and after intervention, daily growth parameters~     and nutritional data, and hospital length of stay.~   "
150192|NCT01600573|"~     This clinical trial shall clarify the efficacy and safety of pazopanib in combination with~     weekly topotecan in patients with platinum-resistant or intermediate platinum-sensitive~     recurrent epithelial ovarian cancer, fallopian and peritoneal carcinoma~   "
150204|NCT01600417|"~     The aim of the study is to evaluate the feasibility and validity of conventional radiographs~     of the lumbo-sacral spine when the patient is lying on a special table which facilitates~     maximal lumbo-sacral flexion. The results gained from the radiographs with the patient on the~     table will be compared with those gained from standard flexion-extension radiographs of the~     lumbo-sacral spine.~   "
150285|NCT01599364|"~     The purpose of this study is to evaluate the virological efficacy of maintenance therapy with~     atazanavir with ritonavir combined with lamivudine in treatment experienced HIV positive~     patients with full and stable virological suppression.~   "
150194|NCT01600547|"~     Osteoporosis and falls occur with increasing frequency among the elderly. Osteoporosis and~     fall increases the risk of fracture. Falls in the elderly are associated with a high~     morbidity and mortality with potentially life-threatening consequences of falls including~     fractures. Besides fracture fall may cause long term problems such as disability fear of~     falling and loss of independence. Today osteoporosis is diagnosed by bone scan of the hip and~     spine. The investigators want to investigate whether other more accessible and less expensive~     testing methods can be used to diagnose osteoporosis. Additionally, the investigators will~     examine the incidence of osteoporosis among the elderly in the municipality of Odense.~     Finally, the investigators would like to investigate the association between factors that can~     lead to falls and to investigate the performance of older and whether there are changes in~     functional ability over time.~   "
150195|NCT01600534|"~     This study includes a behavioral educational intervention that focuses on healthy eating and~     physical activity during pregnancy and the postpartum among women newly diagnosed with~     gestational diabetes mellitus (GDM).~   "
150196|NCT01600521|"~     The purpose of this study is to evaluate the efficacy and safety of a combined therapy for~     rheumatoid arthritis (RA). The combined therapy contained paeoniflorin (Brand name: Pafulin),~     which has anti-inflammation properties, and Cervus and Cucumis polypeptide injection (Brand~     name: Songmeile), which has bone healing, pain relieving, and anti-inflammation properties.~     The hypothesis is that this remedy, which has long been used by the world's largest RA~     community, is effective and safe when tested by modern clinical standards and criteria.~   "
150197|NCT01600508|"~     Background:~      Videoconference (VC) is a common clinical tool and has huge potential to alter medical~     practice and to offer patients the best expertise in treatment and follow-up in spite of long~     distances, especially in rural areas. Studies upon selected patient groups have shown that VC~     is safe and cost-effective. However, RCT of VC patients with stoma problems have never been~     performed.~      Patients with stoma problems are resource demanding patients. The University Hospital North~     Norway (UNN) has several hundred consultations for this patient group each year, serving the~     population in North Norway.~      Methods: In this randomised controlled trial (RCT), patients are either randomised to a VC~     consultation or a regular consultation at the outpatient clinic. All patients with a stoma~     that needs special attention are eligible for inclusion. Patients randomised to the VC group,~     are set-up to a meeting at the nearest VC studio located to their home community. There will~     be educated VC- stoma nurses that will participate in the clinical examination at the~     hospital outpatient clinic and at the rural VC studio.~      Endpoints: Primary endpoints are patient satisfaction and quality of life. Secondary~     endpoints are number of consultations and cost effectiveness.~      Sample size calculations showed that 170 patients had to be included in the trial.~      The investigators hypothesize that postoperative follow-up of stoma patients by VC will not~     have any impact on patients' quality of life compared to Hospital outpatient follow-up.~     Furthermore, the investigators hypothesize that the incremental cost-effectiveness ratio will~     improve.~   "
150198|NCT01600495|"~     The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical~     Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research~     will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant~     women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be~     divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and~     will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of~     cervical dilation. The evaluation will be performed by numerical category scale, location and~     Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a~     questionnaire of customer satisfaction.~   "
150199|NCT01600482|"~     The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and~     effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery~     access site in patients on anticoagulation who are undergoing a percutaneous intervention~     (PCI) procedure using a 6F sheath.~   "
150200|NCT01600469|"~     NMDA activation plays an important role in learning and memory. NMDA receptors were found to~     decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive~     function impairment. This study is a randomized, double-blind, placebo-controlled drug trial.~     All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group~     (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The~     investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive~     function in patients with mild cognitive impairment or mild Alzheimer's disease.~   "
150201|NCT01600456|"~     The specific aims of this study are:~        1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE)~          to that of PE and medication (sertraline).~        2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months~          post-treatment.~        3. To compare those who have chosen their treatment to those who have not in terms of~          completion of treatment, treatment satisfaction, and short- and long-term effectiveness~          of the treatment.~        4. To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.~   "
150202|NCT01600443|"~     The study is undertaken to investigate if the urethral microtrauma, caused by intermittent~     catheterization, differs between three hydrophilic catheters for intermittent~     catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a~     prospective, randomised, cross-over, single-centre study.~      Each subject will be randomized to use three different catheter types. Three catheterizations~     will be performed with each catheter type during one day, with at least two hours between~     each catheterization. The washout period between catheter switch will be at least one week.~      The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters~     with regards to hematuria after intermittent catheterization.~      The secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters~     with regards to pyuria and subjective evaluation after intermittent catheterization.~      The safety of the three catheters will be evaluated in terms of adverse advents, non-serious~     and serious, rated for causality.~      The hypothesis that level of hematuria is equal after using different catheters will be~     tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is~     less than 5%.~   "
150203|NCT01600430|"~     The study hypothesis states that giving early enteral Vitamin D supplementation to preterm~     infants will decrease respiratory morbidity in extremely preterm infants.~   "
150206|NCT01600391|"~     Given that visual information comprises one of the most important and salient sources of~     information used during walking, that visual cues have been shown to be more effective than~     auditory cues in triggering gait adjustments and that stroke survivors have been reported to~     become more dependent on visual cues, the investigators hypothesize that visual cues would be~     more effective in triggering gait recovery and adaptability following stroke than~     interventions not including visual cues.~      The investigators will integrate visual cues with walking and turning practice, and contrast~     this intervention to routine overground walking practice. Stroke participants recruited from~     NHS stroke rehabilitation clinics in the West Midlands, will be randomized to one of three~     gait rehabilitation groups. Each group will receive the same frequency and duration of~     treatment delivered by qualified physiotherapists. Overground visual cue training (OVCT) and~     usual care (UC) groups will be treated in participating NHS sites. Treadmill training with~     visual cues (TVCT) will take place at the University of Birmingham.~   "
150207|NCT01600378|"~     The purpose of this study is to generate a prospective database of all patients evaluated for~     diffuse parenchymal lung diseases to provide much needed data on the various disease~     aetiologies, incidence and prevalence rates, clinical and radiological presentations,~     pathologic correlations, disease progression and response to treatment, and final outcomes in~     this group of patients in Singapore.~   "
150208|NCT01600365|"~     The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of~     conjunctivitis caused by adenovirus.~   "
150209|NCT01600352|"~     The purpose of this study is to evaluate the clinical utility of specific autoantibody~     testing in unmasking an underlying connective tissue disorder in patients who present with~     interstitial lung disease and found to have weak positive ANA (1:400 titre) with no overt~     connective tissue disease manifestations OR borderline/negative ANA with some clinical~     suggestion of connective tissue disease.~   "
150210|NCT01600339|"~     In this phase II multicenter study, the investigators aim to evaluate the efficacy and~     tolerability of a novel taxane-cabazitaxel as single agent second-line chemotherapy for~     metastatic urothelial carcinoma.~   "
150211|NCT01600326|"~     The purpose of this study is to determine the effectiveness of various treatment soft~     tendinosis also known as tendinitis.~   "
150212|NCT01600313|"~     The purpose of this study is to determine the effect of rice bran oil with low calorie diet~     on lipid profiles.~   "
150213|NCT01600300|"~     Hypothesis: external electrical stimulation of the retina with low level electrical currents~     improves visual acuity in subjects with age-related dry macular degeneration.~   "
150214|NCT01600287|"~     The purpose of the study is to evaluate and compare the feasibility, efficacy and safety of~     IAADS (Improved Anaesthetic Agent Delivery System) for propofol anaesthesia against manual~     control using bispectral index in paediatric patients undergoing open heart surgery under~     cardio-pulmonary bypass.~   "
150215|NCT01600274|"~     -  Characterisation of relative bioavailability of Diena (Test) in comparison to Valette®~          (Reference) after single dose administration under fasting conditions~        -  Assessment of bioequivalence of Test vs. Reference after single dose administration~          under fasting conditions, determined by use of area under the concentration time curve~          AUC0-tlast and maximum concentration Cmax obtained for ethinylestradiol (EE) and~          dienogest (DNG)~        -  Descriptive characterisation of safety and tolerability of the investigational products~          in the study population~   "
150216|NCT01600261|"~     Comparison study to assess photo image quality of a new color fundus camera compared to that~     of a commercially available color fundus camera.~   "
150217|NCT01600248|"~     This study will evaluate the usefulness of an online, self-directed treatment for chronic~     pain that has been designed specifically for individuals who are currently or have previously~     served in the military.~   "
150218|NCT01600235|"~     The purpose of this study is to evaluate the safety and efficacy of the induced hypertension~     using phenylephrine in patients with noncardioembolic ischemic stroke.~      The investigators hypothesized that phenylephrine induced-hypertension can result in good~     clinical response without serious complications in patients with noncardioembolic ischemic~     stroke.~   "
150219|NCT01600222|"~     A Phase 2 Maximal Use Systemic Exposure (MUSE) study evaluating the safety and efficacy of~     LEO 90100 used once daily in subjects with extensive psoriasis vulgaris.~   "
150220|NCT01600209|"~     The objective of this study is to confirm the sensitivity and specificity of a stool DNA test~     for detection of colorectal cancer and pre-cancer.~   "
150221|NCT01600196|"~     The purpose of this study is to evaluate the long-term efficacy and safety of surgical~     resection compared with best supportive care in patients with resectable hepatocellular~     carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.~   "
150222|NCT01600183|"~     This is a prospective, randomized, control, open label study in which up to 50 subjects with~     metatarsus adductus (MTA) will be enrolled. Subjects will be treated with the standard~     casting or using the UNFO-s device for total time of 20 weeks.~   "
150246|NCT01599871|"~     The main objective of the study is to determine the effects of low-dose oral theophylline~     added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid~     (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of~     exacerbations defined as increase of symptoms that requires a change of medication~     (antibiotics and/or systemic glucocorticoid) or hospitalisation.~      DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel,~     prospective study. Patient will be recruited during an hospitalisation due to COPD~     exacerbation and randomised at the time of discharge to receive theophylline 100 mg or~     placebo on top of combination therapy with inhaled corticosteroids and long-acting beta~     agonist. The rate of exacerbations will be determined every three months up to one year~     follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of~     them, the following information will be obtained:~        -  Number/severity of exacerbations or hospitalisation since last clinic visit~        -  Compliance and side effects~        -  Blood sample~        -  Plasma levels of theophylline~        -  Sputum (induced)~        -  MMRC~        -  SGRQ~        -  Forced spirometry + inspiratory capacity~           - At the beginning and at the end of the study~        -  6MWT~        -  BMI~        -  BODE~   "
151867|NCT01578538|"~     Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective~     complications.~   "
150223|NCT01600170|"~     HIV associated neurological disorders (HAND), are a major problem even in ART treated people.~     HAND results from chronic inflammation which is largely attributed to expansion and~     activation of monocytes. These activated monocytes, some of which also carry virus to the~     brain, invade the CNS and release cytokines / chemokines resulting in further recruitment of~     monocytes, as well as release viral proteins which injure neurons and cause activation of~     other brain cells. Persistent monocyte/macrophage activation is thus a potential critical~     target for adjunctive therapy to treat or prevent HAND. The investigators therefore propose~     to study the effects of a statin drug (Atorvastatin), which has anti-inflammatory functions,~     on the monocyte activation status in vitro and in ART treated HIV+ individuals.~      The investigators objectives are based on the hypothesis that Atorvastatin treatment will~     reduce the inflammatory and activated phenotype and function of monocytes which have been~     linked to HIV associated neuropathogenesis and occur in HIV infected subjects despite ART. In~     this study the investigators propose to~        1. determine how Atorvastatin modulates monocyte activation, intracellular signaling~          pathways and functions implicated in the pathogenesis of HAND in vitro~        2. define the effect of Atorvastatin on monocyte activation in HIV infected / ART treated~          subjects in a double blind, placebo controlled crossover study~        3. define gene expression patters of monocyte activation before and following statin~          treatment~        4. assess Atorvastatin effects on CNS immune activation markers and neurocognitive function~          in ART treated subjects.~   "
150224|NCT01600157|"~     Background Fast-track concepts reduced hospital stay from 15-20 days to three days for~     patients who underwent a colon resection [1-5]. A well-designed pilot study determined the~     efficacy of a fast-track program for a laparoscopic radical nephrectomy, and the fast-track~     group was discharged earlier from the recovery room median (74+/-23 v 103+/-47 minutes) as~     well as from the hospital median (41+/-11 v 59+/-11 hours) [6]. Implementation of the~     principles of the fast-track program shortened the postoperative hospital stay from eight to~     four days for patients who underwent an open radical nephrectomy [7]. Taek-Gu Lee et al.~     documented how early mobilization after colon surgery resulted in reduced recovery times~     without increased complications [8]. Laparoscopic surgery is minimal invasive with less~     surgical stress, morbidity and mortality [9]. The use of laparoscopic nephrectomy in Denmark~     reduces the hospital stay to 5.2 days which did not meet the foreign countries outcome [06].~      Therefore a combination of the advantages of laparoscopic surgery and the fast-track concepts~     could be used by nephrectomies. However, no prospective studies describing the course after~     nephrectomies, where these advantages are exploited and it is important to make a basic study~     to describe and understand the factors of surgical outcome.~      Aim of study To describe the postoperative period after laparoscopic trans-peritoneal~     nephrectomy that performed as an ambulatory procedure.~      Method A prospective study will involve 62 patients who have been diagnosed with Cancer Renis~     DC649.~      All patients will receive the results of CT-scanning at outpatient and of them who meet the~     inclusion criteria for the study will be informed about the study and will receive a written~     information according to appendix 1., and a new time with (NA) to get the results for kidney~     function and oral information about the study as well as their acceptation to be connected to~     the study, those patients will receive a standard recommendation to be discharged from~     hospital on the day of their operation and they will restart their normal activities the day~     after the operation unless there are preventing factors. All patients will be thoroughly~     informed by the examiner how to complete the questionnaire and will come through different~     tests according to appendix 2., a blood test will be taken according to appendix 12.~      All patients should have a CT-scanning of abdomen, chest X-ray and kidney function test~     before the operations.~      Statistic The number of patients, have been decided to be included to each study, is based on~     the realized number of nephrectomy operations that can be done during the specified period~     within each department and not on the statistic power of study.~      The Scheffé's test will be used for multiple comparisons. The correlation between variables~     will be evaluated by using the Spearman's rank correlation coefficient. P values less than~     0.05 is considered significant. Statistical analyses will be performed by SPSS statistic~     program software.~      Publications The results of each study, irrespective of whether these are positive or~     negative, will be published in international scientific journals and will be distributed at~     relative conferences. The published articles will have Azawi NH as first author, Christensen~     T as last author and co-authors according to Vancouver rules.~      Ethics The study will be reported to the Danish National Committee on Biomedical Research~     Ethics and regionsjaelland paraplygodtkendelsen data control, Ph.D. student (NA) will apply~     for enrollment to the PhD programme at the University of Copenhagen. Consent forms will be~     received from all patients and they will receive written information about project. The~     project will protect all of the data gathered.~   "
150225|NCT01600144|"~     Mammographical data collection (raw data) for CAD evaluation by VUCOMp software.~   "
150226|NCT01600131|"~     Aims and Intervention:~      The long-term goal is to implement stroke caregiver programs that involve low-cost~     interventions that are sustainable in routine clinical practice. The immediate objective is~     to test, using a randomized controlled trial, a problem-solving intervention for stroke~     caregivers that can be delivered during the transitional care period (e.g., time which~     Veteran is discharged to home) followed by online, in-home sessions. The investigators will~     modify the traditional, problem-solving intervention by adding web-based training using~     interactive modules, factsheets, and tools on previously developed and nationally available~     RESCUE Caregiver website (www.cidrr8.research.va.gov/rescue). The investigators will also~     provide on-line, skills training and application of the problem-solving approach via the~     RESCUE messaging center. The immediate, primary aim (#1) is to test the effect of the~     intervention on stroke caregivers' depressive symptoms at 11 and 19 weeks after baseline data~     collection. Aim #2 is to test the effect of the intervention on stroke caregivers' burden,~     positive aspects of caregiving, self-efficacy, health-related quality of life (HRQOL), and~     satisfaction with care at 11 and 19 weeks after baseline data collection. Aim #3 is to test~     the effect of the intervention on Veterans' outcomes: functional abilities and healthcare~     utilization (i.e., unintended hospital bed days of care, number of emergency room visits,~     number of unscheduled clinic visits) at 11 and 19 weeks after baseline data collection. Aim~     #4 is to determine the budgetary impact for implementing the intervention. Aim #5 is to~     determine the facilitators, barriers and best practices for implementing the intervention.~      Design and Methods:~      The investigators will conduct a two-group randomized controlled trial. The investigators~     will enroll 240 stroke caregivers at 8 study sites (North Florida/South Georgia Veterans~     Healthcare System, Miami VA Healthcare System, James A. Haley Veterans Hospital in Tampa,~     Michael E. Debakey VAMC in Houston, Hunter Holmes McGuire VAMC in Richmond, Central Arkansas~     Veterans Healthcare System, VA Tennessee Valley Healthcare System, and the VA Boston~     Healthcare System). Eligible caregivers will be interviewed, complete baseline measures, and~     then be randomized to two groups: 1) intervention group, or 2) standard care. A team member~     will telephone caregivers at 11 weeks and 19 weeks after baseline data collection to answer~     questions on instruments with established reliability and validity. Qualitative interviews~     will be conducted with selected caregivers to obtain in-depth perceptions of the value,~     facilitators, and barriers of the intervention.~      Impact:~      This is the first known study to test a transition-to-home intervention combined with~     technology to improve the quality of caregiving and the recovery of Veterans.~   "
150227|NCT01600118|"~     This randomized clinical trial investigates the effect of the extracorporeal shockwave~     therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically~     approved non invasive method to influence bone turnover and tissue regeneration. The~     hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically~     aligned teeth as well as increase the blood flow. Increasing the periodontal stability would~     reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding~     tissues.~   "
150228|NCT01600105|"~     Patients with chronic liver disease are at high risk of developing liver scarring (fibrosis),~     with ultimate risks of cirrhosis and liver cancer that may require liver transplant. The~     investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI)~     techniques (MR diffusion, perfusion and elastography) to assess the degree of liver damage in~     patients with chronic liver disease. These techniques combined could reach high diagnostic~     performance for detection of liver fibrosis; and could decrease the number of liver biopsies,~     which have risks and sample only a small portion of the liver.~   "
150229|NCT01600092|"~     A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™~     with the existing formulation in infants. The primary hypothesis of the study is that the new~     formulation will be noninferior to the existing formulation on the basis of immunogenicity.~   "
150230|NCT01600079|"~     This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of~     herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared~     to a cohort of unvaccinated participants.~   "
150231|NCT01600066|"~     Obstructive sleep apnea has been linked to erectile dysfunction. Furthermore, small studies~     suggest that treatment of sleep apnea by continuous positive airway pressure (CPAP) may~     reverse erectile dysfunction in affected patients. The present study aims to investigate in a~     larger cohort if severe sleep apnea is independently associated with erectile dysfunction and~     if 6-12 months of CPAP therapy lead to an improvement of erectile dysfunction.~   "
150232|NCT01600053|"~     The purpose of this study is to determine whether on course (6 cycles) of consolidation~     therapy with Revlimid can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL) in~     the bone marrow.~   "
150233|NCT01600040|"~     Proton beam radiation therapy is known to spare surrounding normal tissues from radiation.~     Proton beam radiation delivers less radiation beyond the area of the target tissues. This may~     reduce side effects that patients would normally experience with standard (photon) radiation~     therapy which tends to unavoidably include more normal tissue along with tumor target tissue.~      In this research study, the investigators are looking to determine if proton beam radiation~     is effective in controlling your cancer growth. The investigators are also looking to see if~     proton beam radiation can reduce side effects when compared to standard radiation treatment~     (photon radiation).~   "
150247|NCT01599858|"~     The objectives of this study were:~      To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to~     their effect on basal- and food- stimulated gastric pH in healthy volunteers.~      To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to~     their effect on basal and meal stimulated pH.~      To assess the safety, tolerability and pharmacokinetics of repeated doses of YF476 in healthy~     volunteers.~   "
150234|NCT01600027|"~     Fractures of the shaft of femur (FSF) are common in children, especially isolated fractures~     of the mid-third of the femur which are intensely painful. The pain of the fracture is~     thought to originate from the femoral shaft periosteum and muscle spasm from the quadriceps~     mechanism. Fascia iliaca compartment block FIC is easy and simple technique, there is no need~     for high-skill or expensive equipments. It has higher success rate in more than 90%of the~     children thigh procedures.~      Potentially dexmedetomidine has become an alternative to clonidine, it is a highly selective~     α2 agonist having about an 8-10 times affinity for α2 adrenergic receptors than clonidine and~     much less α1 effects, which is responsible for the hypnotic and analgesic effects. Perinural~     dexmedetomidine in combination with bupivacaine or ropivacaine enhance sensory and motor~     block without neurotoxicity in experimental studies.It has been reported to improve the~     quality of intrathecal, Epidural, and caudal anesthesia in children. Also, it is safe and~     effective in IV regional anesthetic and axillary block in adult. No study-up to the date -has~     been carried to evaluate its effect on the character of fascia iliaca compartment blocks as~     adjuvant to bupivacaine. The objectives of this study were designed to detect the effects of~     addition dexmedetomidine (Precedex- Abbot) as adjuvant to bupivacaine for fascia iliaca block~     on the quality of postoperative analgesia and also to determine its effects on the~     hemodynamics, recovery behaviors, sedation and possible side effects in children undergoing~     thigh surgeries (fracture femur).~   "
150235|NCT01600014|"~     The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in~     treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in~     a previously cleared field.~   "
150236|NCT01600001|"~     The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic~     Idiopathic Constipation (CIC) patients.~   "
150237|NCT01599988|"~     The Clinical Research Ethics Committee, Cork comprises of faculty representatives, external~     representatives, legal representatives and appropriate individuals and ex-officio~     administrative members with needed expertise. Ethics Committee members, including the Chair,~     are appointed by the Head of College, University College Cork, Medical School.~      The Ethics Committee meets once a month.~   "
150238|NCT01599975|"~     This study is being done to see if a drug called long acting methylphenidate (Concerta) is~     safe and effective as a treatment for problems with mental function in adults infected with~     HIV.~      A subset of patients with HIV-associated memory loss have a defect in the speed with which~     they learn and process information. Methylphenidate drugs, such as Ritalin or Concerta, have~     been shown on tests to improve the ability to rapidly absorb information; these tests are~     called reaction time tests. These drugs are already FDA-approved to treat Attention Deficit~     Disorders: ADD or ADHD.~      At baseline, all subjects get tests of memory and brain function; then they are split into~     two groups. One group on this study will receive Concerta for 2 weeks, and a second group~     will receive a placebo x 2 weeks. After that period both groups will receive memory and other~     tests of brain function, and then the groups will switch. The first group will receive~     placebo and the second will receive Concerta x 2 weeks, followed by more memory and~     neurological tests. After that all subjects will have the option to receive Concerta for free~     for 8 more weeks. At the last visit all subjects get memory and brain tests again.~   "
150239|NCT01599962|"~     To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in~     healthy humans.~   "
150240|NCT01599949|"~     The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients~     with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy~     regimen and who progressed after bortezomib therapy.~   "
150241|NCT01599936|"~     There is no FDA approved therapy for the treatment of scorpion envenomation. Centruroides~     scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging~     from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical~     syndrome which may require sedation with benzodiazepines and observation for 6 to 28 hours of~     intensive care monitoring. A safe therapy is necessary to halt the progression of symptoms~     early in the clinical course while avoiding the clinical deterioration that can occur en~     route to a tertiary facility. Alacramyn® is anticipated to be safer and more effective than~     the present standard of care, midazolam, and faster-acting thus eliminating the need to~     transport most rural patients and reducing hospitalization time.~   "
150242|NCT01599923|"~     There is no FDA approved therapy for the treatment of scorpion envenomation in the United~     States. Centruroides scorpion envenomation produces a pattern of neurotoxicity with a~     spectrum of severity ranging from trivial to life threatening. Patients stung by Centruroides~     scorpions develop a clinical syndrome which may require sedation with benzodiazepines and~     observation for 6 to 28 hours of intensive care monitoring. A safe therapy is necessary to~     halt the progression of symptoms early in the clinical course while avoiding the clinical~     deterioration that can occur en route to a tertiary facility. Alacramyn® is anticipated to be~     safer and more effective than the present standard of care in the United States, midazolam,~     and faster-acting thus eliminating the need to transport most rural patients and reducing~     hospitalization time.~   "
150243|NCT01599910|"~     This study will evaluate the effect of scribes on an academic emergency department.~   "
150244|NCT01599897|"~     The purpose of this study is to determine the safety, tolerability, and immunogenicity in~     healthy adult subjects of an investigational vaccine being developed for the prevention of~     pulmonary tuberculosis. The vaccine, identified as ID93 + GLA-SE, consists of the recombinant~     four-antigen Mycobacterium tuberculosis recombinant protein ID93 together with the adjuvant~     GLA-SE.~   "
150245|NCT01599884|"~     N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is~     widely prescribed for patients with chronic obstructive pulmonary disease (COPD),~     particularly for those who have accompanying symptoms of chronic cough and sputum production.~     Randomized, placebo controlled indicate that it is safe and that it may have some clinical~     benefit when used at relatively low doses. It is postulated that substantially higher doses~     of NAC will be well-tolerated and will provide better symptom control while also decreasing~     blood makers of oxidant stress and inflammation.~   "
150248|NCT01599845|"~     Investigation of the differences between the levels of extracellular and intracellular~     nano-particles in workers exposed to environmental particles during their employment to~     enhance understanding the process of penetration of the particles to respiratory epithelial~     cells.~   "
150252|NCT01599793|"~     This study is being done to help researchers understand more about prostate cancer that has~     spread to the bones by using the newest magnetic resonance imaging (MRI) techniques and to~     better understand the effect of an experimental drug called XL184 (or cabozantinib) on bone~     disease. The other purposes of the study are to better understand the effect of XL184 on~     prostate cancer progression, bone pain, and on any cancer cells that patients may have~     circulating within the blood (called circulating tumor cells)~   "
150253|NCT01599780|"~     This research investigates the ways in which preterm birth affects how very young children~     learn to speak and understand language, and how older children gain efficiency in language~     processing. The investigators observe how children at different ages learn new words and~     comprehend familiar words, how they communicate effectively with others, and how they use~     both linguistic and non-linguistic skills in problem-solving. All of the activities in the~     investigators' studies are designed to be age-appropriate and fun for children.~   "
150254|NCT01599767|"~     The purpose of this study is to see the effects of transcranial direct current stimulation~     (tDCS) on the pain associated with spinal cord injury. This study is part of the~     Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease~     in pain levels with active stimulation, when compared to sham stimulation, using a 3 week~     stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of~     stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also have~     follow ups at 2, 4 and 8 weeks after the second course of stimulation.~      If a subject receives sham during the experiment, he/she may enroll in an open-label portion~     of the study and receive 10 days of active stimulation.~   "
150255|NCT01599754|"~     The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or~     delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high~     risk patients.~   "
150256|NCT01599741|"~     ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise~     reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose~     significantly. This is realized by anatomy-specific optimization of the full acquisition~     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing~     engine) for every clinical task individually. Furthermore, smaller focal spot sizes, shorter~     pulses and the introduction of automatic real-time motion compensation in subtraction imaging~     are used, which are known to positively influence image quality . The final effect on the~     clinical image quality in peripheral angiography is investigated in this study.~   "
150257|NCT01599728|"~     Despite modern advances in treatment, heart failure continues to carry a poor prognosis with~     high morbidity and mortality rates. Hence, there remains a major interest in the development~     of novel therapeutic agents for this debilitating condition. Urocortins have recently shot~     into limelight with their potential role in the pathophysiology and treatment of heart~     failure.~      Recent studies by the investigators group (REC no: 09/S1103/41) have confirmed that Urocortin~     2 and 3 are potent arterial vasodilators, the effects of which are reproducible and well~     tolerated in healthy male volunteers. Previous studies using heart failure models in~     animals1-7, as well studies in heart failure patients (Urocortin 2), suggest that there is~     great scope for Urocortins as novel biomarkers and as potential therapeutic agents in heart~     failure. With this in mind, the investigators wish to study the local vasomotor effects of~     these peptides in greater detail in patients with heart failure.~   "
150258|NCT01599715|"~     More than one in three US women suffers from the distressing, embarrassing, and often~     unreported problem of urinary incontinence (UI). UI severity increases with age and the~     financial cost exceeds $19 billion per year . The Adult Conservative Management Committee of~     the 2008 International Consultation on Incontinence concluded that pelvic floor muscle~     training (PFMT) should be offered as first line therapy to all women with stress, urge, or~     mixed UI; and that bladder training (BT) may be preferred to drug therapy. Conservative~     strategies are low risk and differ from other forms of UI management in that they do not~     prejudice future treatments. They also may decrease symptoms of urgency and frequency that do~     not entail UI, but greatly reduce the quality of life for nearly 1 in 11 US women.~   "
150259|NCT01599702|"~     The study is a prospective, non-controlled, open-label multi-centre pilot safety study of~     iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory~     Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two~     treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will~     receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion,~     whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV~     iron isomaltoside 1000 divided into two administrations.~   "
150260|NCT01599689|"~     This pilot cluster-randomised controlled trial aims to determine whether the use of bedside~     mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium~     and improve outcomes in the older cardiac surgical patient.~   "
150261|NCT01599676|"~     The aim of this study is to assess the effect of citrulline supplementation on muscle~     strength in elderly institutionalized subjects undergoing a resistance exercise training~     program. The primary endpoint is the outcome of maximum strength of knee extensor muscles.~   "
150262|NCT01599663|"~     The purpose of this study is to evaluate the effect of an algorithm, where ICU patients pain~     are assessed systematically with valid pain assessment tools and where pain is treated after~     pain intensity score.~   "
150263|NCT01599650|"~     This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing~     administered with or without adjunctive laser treatment versus laser photocoagulation (the~     current standard of care) up to Month 6 in patients with visual impairment due to ME~     secondary to BRVO. Additionally the results of this study will provide long-term (24-month)~     safety and efficacy data for ranibizumab, administered with or without adjunctive laser~     treatment in this indication.~   "
150264|NCT01599637|"~     The study is designed to explore the mode of action for omalizumab therapy in patients with~     chronic idiopathic urticaria.~   "
150286|NCT01599351|"~     The objective of this study is to evaluate the radiation dose to patient at two positions~     (prone and left lateral) and to medical staff during Endoscopic retrograde~     cholangiopancreatography (ERCP) procedure using dose area product (DAP) meter and~     thermoluminescent dosimeter (TLD). Data were recorded on 20 patients at prone position and 20~     patients at left lateral position.~   "
150265|NCT01599624|"~     The Stress Resilience Training System (SRTS) program is a stress reduction and resilience~     building system that blends cognitive training to anticipate the effects of stress with~     advanced biofeedback to mitigate stress effects and aftereffects, using a game-based learning~     framework on an iPad platform.~      The proposed study will evaluate the effectiveness of the SRTS program at reducing perceived~     stress, PTSD symptoms, depression, anxiety, sleep quality, coping, attrition and~     class/operational performance among United States Navy service members.~   "
150266|NCT01599611|"~     The objective of this study was to investigate whether infants with total serum bilirubin >~     450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin~     encephalopathy develop long term sequelae with impairment of motor development, hearing and~     executive function compared with a control group.~   "
150267|NCT01599598|"~     Military operations and training situations present many physical and psychological~     challenges for service members to adapt to and overcome. The challenges of these changing~     conditions necessitate having to cope with stress, which is seen as the negative perceptions,~     feelings, and emotions that manifest from the subjective physical and/or mental strain on~     life processes. In addition, service members are returning from deployments having gone~     through traumatic experiences that can develop into posttraumatic stress disorder (PTSD),~     depression or other serious conditions. The Surface Warfare Independent Duty Corpsman (IDC)~     School is an example of a training environment where some students may be entering the~     program with symptoms of PTSD, which may preclude or make it more difficult for them to~     perform well. Autonomic nervous system (ANS) dysregulation has been observed in patients with~     PTSD and those experiencing chronic stress, such that there is more arousing, sympathetic~     input to the heart than calming, parasympathetic input, which is usually the dominant~     division of the ANS involved in controlling one's heart rate. The IDC training program is an~     example of an environment where the service member is expected to excel while being subjected~     to multiple sources of stress. The fast tempo coupled with performance expectations may~     induce stress and actually inhibit learning. The Institute of HeartMath has developed the~     Coherence Advantage program which teaches one to self-regulate their emotions while focusing~     on breathing to compliment the active process of self-regulation. In conjunction, the emWave~     Personal Stress Reliever allows the user to receive heart rate variability (HRV) biofeedback,~     hence giving the user the opportunity to self-regulate their ANS through breathing and~     self-regulation techniques. The proposed study will test the effectiveness of the Coherence~     Advantage program versus progressive muscle relaxation (PMR) in reducing stress~     symptomatology among Surface Warfare IDC students. The effectiveness of these two different~     interventions will be compared on outcomes of PTSD, depression, anxiety, sleep quality,~     perceived stress, attrition, and class performance.~   "
150268|NCT01599585|"~     This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment~     for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major~     and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA~     delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and~     depression as in-person BA treatment for depression.~   "
150269|NCT01599572|"~     Background: Zinc supplementation has the potential to improve serum zinc levels and immunity~     of zinc deficient nursing home elderly.~      Objective: To determine the effect of zinc supplementation of 30mg/d for 3 months on serum~     zinc levels and T-cell mediated function of zinc deficient nursing home elderly.~      Design: This is a randomized, double-blind, placebo-controlled study. Outcome measures~     included change in serum zinc levels and various T-cell mediated immune factors between~     baseline and month 3.~      Hypotheses: The investigators hypothesize that zinc supplementation of 30mg/d for 3 months~     will improve serum zinc levels as well as various T-cell mediated immune factors in zinc~     deficient nursing home elderly.~   "
150270|NCT01599559|"~     Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and~     the monoclonal antibody rituximab (chemoimmunotherapy).~      Following chemoimmunotherapy patients receive radiation therapy if they have residues which~     may be active tumour. However at the end of chemoimmunotherapy the majority of patients show~     tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to~     be a good tool to accurately identify active tumor from scar tissue in patients treated for~     mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really~     necessary in patients where PET/CT has shown that the tumor is no longer active. Therefore we~     will compare radiation treatment with careful observation.~      Patients that at the end of conventional treatment of chemoimmunotherapy have a negative~     PET/CT (i.e., without residues suspected to contain active tumor), will randomly assigned to~     two different treatment groups: one treatment group will receive the radiation treatment, and~     the other treatment group will receive careful observation.~      The trial is planned according to a non-inferiority design aimed at demonstrating that~     progression free survival after the experimental treatment (observation) is not worse than~     after the standard comparator (mediastinal irradiation.Participation in this study could~     spare patients with complete remission at the end of chemo immunotherapy (PET/CT negative)~     radiation therapy that may be unnecessary.~   "
150271|NCT01599546|"~     The purpose of this study is to understand reading abilities of children born preterm: their~     cognitive profiles, the neural basis of good and poor reading abilities, and the behavioral~     and neural factors that predict persistent difficulties. The investigators hope to learn~        -  what specific skills correlate reading skills~        -  if preterm children have different cognitive profiles than full term children with~          respect to reading~        -  if cognitive skills measured in kindergarten predict reading ability in the second grade~        -  if parts of the brain are associated with reading skill~        -  whether brain characteristics in kindergarten predict reading in second grade.~   "
150272|NCT01599533|"~     Many publications deal with the natural history of aortic aneurysms in literature. Except for~     connective tissue disorders as Marfan or Loeys-Dietz syndrome, aortic aneurysms are a complex~     multifactorial disease with genetic and environmental risk factors. Susceptibility loci~     identified in thoracic aortic aneurysms (TAA) and abdominal aortic aneurysms (AAA) do not~     overlap, suggesting that different genetic risk factors contribute to these two forms of~     aneuryms. With a higher prevalence correlated to ageing (5%), AAA is usually presented as the~     degenerative form of the disease. However, a recent epidemiologic study by Olsson et al. has~     revealed an increasing incidence of thoracic aortic disease among older individuals (70+/-12~     years) with 60% of aneurysmal rupture or dissection at diagnosis, and a 1.7 :1 male-to-female~     ratio compared to 6:1 in AAA. From this current knowledge arises the concept of diffuse or~     plurisegmental degenerative aneurysmal aortic disease, poorly explored so far. As regards to~     the prevention policy, there is a consensus statement in which ultrasonography screening for~     AAA is recommended for all individuals aged > 60 years (particularly in men who have ever~     smoked) and for those aged > 50 years with family history of AAA. Nevertheless, screening for~     a concomittant thoracic location of the disease (except thoracoabdominal aneurysm) is not yet~     required, whereas it could change the prognosis of the patients and influence their~     management.~   "
150273|NCT01599520|"~     Cancer patients receiving chemotherapy experience a number of aversive symptoms that are~     accompanied by declines in physical and mental well-being. Although the benefits of stress~     management training interventions on quality of life are well documented, there are no~     published studies examining the efficacy of these interventions among Hispanic women and~     Latinas (hereafter referred to as Latinas) receiving chemotherapy. This dearth of research~     reflects the general lack of stress management interventions for cancer patients whose~     preferred language is Spanish. Simply translating existing English-language interventions~     into Spanish may seem to be a solution for the lack of Spanish-language stress management~     interventions. This approach, however, does not take into account cultural values, beliefs~     and situational realities that are likely to contribute to patients' uptake of health~     promoting behaviors. The proposed research seeks to address this gap by evaluating a stress~     management training intervention developed specifically for Latinas beginning chemotherapy~     for cancer.~      In response to the identified need, the investigators created a Spanish-Language~     Self-Administered Stress Management Training (SL-SAT) intervention Cómo tratar el estrés~     durante la quimioterapia (How to manage stress during chemotherapy). The intervention is~     based on an English-language self-administered stress management training intervention the~     investigators previously developed and showed to be efficacious in a randomized controlled~     trial. Development of the Spanish-language intervention was the result of extensive use of~     ethnographic and learner verification methods, guided by a community-based participatory~     research approach. Similar to the English-language version, the SL-SAT intervention consists~     of a digital video disc(DVD), booklet, and audio compact disc (CD), and provides instruction~     in three well-established stress management techniques: deep breathing; progressive muscle~     relaxation and guided imagery; and use of coping self-statements. The proposed study will~     evaluate the efficacy of this transcreated intervention in a randomized controlled trial~     involving Spanish-speaking Latinas about to begin chemotherapy for cancer. Following a~     baseline assessment, participants will receive usual care or usual care plus the SL-SAT~     intervention. Participants will be reassessed on study measures approximately 7 and 13 weeks~     after the baseline assessment.~   "
150274|NCT01599507|"~     The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the~     correction of anemia in non-dialysis chronic kidney disease patients.~   "
150275|NCT01599494|"~     This study, conducted in India, will be recruiting women participants who are between the~     ages of 18 and 42, and who have an indication for controlled ovarian stimulation (COS), but~     have not yet undergone in-vitro fertilization and/or intracytoplasmic sperm injection~     (IVF/ICSI). The study is designed to compare the difference in oocyte (immature egg cell)~     production after administration of the investigative drug, MK-8962 (corifollitropin alfa) +~     recombinant follicle stimulating hormone (recFSH), in contrast to use of only the reference~     drug, recFSH.~   "
150276|NCT01599481|"~     The aim of the investigation is to evaluate the effectiveness and costeffectiveness of a~     model of supported employment (the Individual Career Management (ICM) model) designed to help~     people with common mental illness return to work.~   "
150277|NCT01599468|"~     The purpose of this study was to evaluate the effect of early administration of tranexamic~     acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery.~      This was a randomised, placebo controlled trial including 74 patients. The investigators~     included ASA1 parturients with correct haemostatic status undergoing cesarean section under~     spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and~     starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg~     of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the~     2 following hours. Placebo Group received same volumes of normal saline. The investigators~     compared blood loss and transfusions in both groups.~   "
150278|NCT01599455|"~     Following spinal cord injury (SCI), the body loses normal control of blood pressure and heart~     rate, and there is a risk of sudden and dangerous increases in blood pressure, namely,~     autonomic dysreflexia (AD). It is important to be aware of baseline blood pressures and heart~     rates in individuals in order to detect AD. However, baseline values vary in developing~     children, and may be more variable in children with SCI. Thus, the objective of this study is~     to determine baseline blood pressure and heart rate measurements in children with SCI during~     rest and during urodynamic testing.~      The investigators hypothesize that 1) blood pressures will increase with increasing age and~     body mass index; 2) heart rate will decrease with increasing age; 3) blood pressures will~     increase with increase in bladder filling; 4) blood pressures will increase will increase~     with increasing duration of injury.~   "
150279|NCT01599442|"~     Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous~     system), vascular, mechanic and metabolic factors, which are further complicated by an~     impairment of the immune system and a corresponding increase in the risk for infections.~     Results from clinical trials about the efficacy of interventions aimed at reducing the number~     of patient-relevant end points are of limited comparability due to the heterogenity of~     patient characteristics. By their very nature, randomized clinical trials (RCT) can only~     focus on a limited section of the wide range of possible intervention regimes. In clinical~     practice, however, a number of patients with dfs will never have been part of a clinical~     trial. Furthermore, there are only very few contemporary registers for this indication from~     which conclusions with regard to the comparative merits of different therapeutic strategies~     may be drawn.~      The register was conceived to find out to which extent RCT patients are representative for~     the overall patient collective with dfs and critical limb ischemia and to evaluate the~     therapeutic success of other treatment strategies. An RCT to assess the efficacy of urokinase~     versus placebo is imbedded in the register.~   "
150280|NCT01599429|"~     Positron emission tomography uses various radioactive tracers to measure the metabolic~     activity in a none-invasive way, and specially to follow the activity of the disease during~     the treatments.~      Among those new tracers, fluorothymidine (18F-FLT) arouses a lot of interest. This new tool~     would allow to image and follow time wise acute myeloid leukemia (AML). The investigators~     want, with the (18F-FLT), to characterise the aggressivity of the tumors and the prognostic~     before and after chemotherapy treatment.~      The aim of this study is to be able to identify earlier the responders, because if they are~     detected sooner, these patients will benefit from more aggressive treatments.~   "
150281|NCT01599416|"~     The purpose of this study is to understand the effect of using oral U-relax on HPV infected~     women for vaginal environment health promotion, and the HPV DNA Test Index change from~     positive to negative. Long-term infection of HPV is associated with cervical cancer. U-relax~     contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on~     treatment of BV, UTI, IBD and can improve vaginal environment health. Patients with positive~     result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of~     cervical cancer. This clinical trial tries to reveal the influence of oral U-relax and~     patients with HPV DNA test positive result.~   "
150282|NCT01599403|"~     The primary objective of this study is to investigate whether continuous PVB is equal in~     efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2, or~     is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs~     equal to or greater than 1.2.~   "
150287|NCT01599338|"~     Besides their potential action in the treatment of type 2 diabetes mellitus (T2DM), GLP-1~     analogues decrease satiety and food intake leading to a significant weight loss in patients.~     However, little is known about their effects on food hedonic sensations and taste perception.~      The aim of this study is to investigate the impact of Liraglutide on the liking and wanting~     components of the food reward system, taste sensitivity and sensory specific satiety in type~     2 diabetes mellitus (T2DM) patients. According to the review of literature in animal models,~     it is expected that Liraglutide will modify food preference and gustative perception in~     humans.~      Thirty T2DM patients will be studied before and after 3 months of treatment with Liraglutide~     (1.2 mg/day). Same tests will be carried out on two consecutive days before and after the~     treatment administration. Olfactory liking, recalled liking and wanting for several food~     items will be assessed. Sensory specific satiety will be measured as well as detection~     thresholds for salty, sweet and bitter tastes. Subjects will also answer questionnaires on~     hunger, pleasure in eating, and food intake.~   "
150288|NCT01599325|"~     The purpose of the study is to determine whether azacitidine is safe and effective in the~     treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).~   "
150289|NCT01599312|"~     In this randomized crossover trial the investigators test whether three different brands of~     videolaryngoscopes (VLS) exhibit reduced forces on both upper and lower teeth, and compare~     them with a classic Macintosh laryngoscope blade.~   "
150290|NCT01599299|"~     The purpose of this study is to determine whether there is a difference between the diameter,~     and the cross-sectional area of the right internal in left internal jugular vein in~     preoperative, mechanically ventilated patients.~      Secondary the relationship between the internal jugular vein to the common carotid artery~     will be examined.~   "
150291|NCT01599286|"~     The overall objective of this drug trial is to determine whether the treatment of acute~     hyperammonemia with N-carbamyl-L-glutamate (NCG, Carglumic acid) in propionic acidemia (PA),~     methylmalonic acidemia (MMA), late-onset CPS1 deficiency (CPSD) and late-onset Ornithine~     transcarbamylase deficiency (OTCD) accelerates the resolution of hyperammonemia efficiently~     and safely.~      The primary goal is to determine if the study drug (NCG) efficiently reduces ammonia levels~     following a hyperammonemia episode(s).~      Secondly, the investigators want to know if treatment with this study drug (NCG) efficiently~     improves neurologic function, reduces plasma glutamine levels and lessens the duration of~     hospitalization after each episode of hyperammonemia.~   "
150292|NCT01599273|"~     Thyroid-associated ophthalmopathy (TAO) is an autoimmune process that can affect the orbital~     and periorbital tissues and the thyroid gland. Periorbital inflammation can cause swelling,~     fatty infiltration, and scarring of the eyelid muscles resulting in eyelid retraction and~     upper scleral exposure, which is the most common clinical features of TAO.Even with mild~     eyelid retraction and swelling, most patients become disappointed and depressed due to their~     cosmetically unacceptable appearance, and they are unwilling to wait for spontaneous~     resolution or a clinically inactive period for surgical intervention. Thus, most~     ophthalmologists and endocrinologists recommend surgery in the chronic burnt-out stage.~     Several treatment options have been described for correction of eyelid retraction, including~     Botox and filler injection, and surgeries in the burnt-out stage such as lowering the upper~     lid by recessing the levator muscle, excision of Müller's muscle, introducing a spacer, or~     myotomies.Surgical options have significant risks as well as an unpredictable course and~     outcome in some cases. Several authors have reported that subconjunctival botulinum toxin~     injection provides an immediate, effective treatment by reducing excessive levator function~     in patients who suffer from disfiguring eyelid appearance and do not want to wait for surgery~     for upper eyelid retraction.Botox treatment is usually temporary. However, unwanted ptosis,~     although temporary, was observed in five out of 24 patients (20.8%) in the study by Costa,~     which may be even more disappointing and cosmetically unacceptable to some patients.Recently,~     hyaluronic acid gel fillers, which were injected into the subconjunctival levator-Muller~     plane, demonstrated efficacy in managing Graves' eyelid retraction in three patients.However,~     complications such as a lumps, fluid buildup, and skin pigment darkening may occur using this~     technique.Steroid treatment represents a well-established TAO management strategy due to its~     anti-inflammatory and immunosuppressive actions. However, multiple systemic side effects such~     as diabetes, infection, hypertension, osteoporosis, and stomach ulcers are major drawbacks of~     systemic steroid treatment. Due to limitations of systemic steroid treatment, several studies~     reported TAO improvement with periorbital injections of methylprednisolone and triamcinolone,~     primarily focusing on reducing proptosis and diplopia. So far, however, only a single small~     case series study has suggested that an injection of 20 mg triamcinolone into the~     subconjunctival region of the lid, between the conjunctiva and Muller's muscle, improves~     upper eyelid retraction within 1 month in three of the four patients. The investigators are~     not aware of any study designed to demonstrate the treatment efficacy of locally administered~     triamcinolone to improve eyelid retraction and swelling in a prospective manner. Therefore,~     we aimed to evaluate both the short-term and long-term effects of subconjunctival~     triamcinolone injections in treating eyelid retraction and inflammatory swelling caused by~     TAO.~   "
150293|NCT01599260|"~     People with rheumatic disease often have decreased strength, muscle mass, and bone mineral~     density due to repeated bouts of inflammation, normal effects of aging, disuse, and~     inactivity. The medications used to quell the disease process, such as prednisone, can also~     have detrimental effects on body composition, strength, and functional capacity. The~     investigators propose to investigate the feasibility, safety, and effects of resistance~     exercise in older patients with rheumatoid arthritis (RA) and vasculitis. The unique~     resistance protocol the investigators propose involves performing movements in a slow and~     controlled fashion (i.e., no acceleration or use of momentum in the lifting and lowering of~     the resistance) to minimize force on the joints and connective tissues. This will be~     conducted in an individually-supervised environment with a new generation of exercise~     equipment that will accommodate their musculoskeletal capabilities and allow for~     reproducibility of the exercise protocol. The investigators intend to investigate the~     feasibility, safety, musculoskeletal, and psychological effects of this resistance exercise~     protocol in older patients with rheumatoid arthritis and vasculitis by testing their~     strength, body composition, functional ability, mood, and quality of life before and after~     this 16-week resistance exercise intervention.~   "
150294|NCT01599247|"~     Specific aim #1: To assess the study team's ability to recruit subjects in this cohort and to~     successfully complete follow-up assessments by phone or mail.~      Hypothesis: Over 50% of eligible subjects will enroll in the observational study, and 70% of~     follow-up assessments will be successfully completed.~      Specific aim #2: To determine the natural history of hopelessness, ongoing suicidal thoughts,~     and optimism in subjects at 2, 4 and 8 weeks after discharge.~      Hypothesis: Subjects will continue to have moderate levels of hopelessness, suicidal~     thoughts, and optimism at follow-up assessments.~   "
150295|NCT01599234|"~     The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of~     spasticity in multiple sclerosis~   "
150296|NCT01599221|"~     This is an observational, retrospective and prospective study where subjects who have~     undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be~     followed for data collection since the day before their surgery (retrospectively) until day~     180 after surgery (retrospectively and prospectively).~      This study is aimed at collecting data from patients who have already been treated with EBA2~     nail. Data collection will cover the details of the fracture and surgery (from which the~     retrospective nature of the study), as well as details of follow up visits after surgery that~     patients routinely carry out up to 6 months (from which the prospective nature of the study).~      The study will be conducted in three clinical sites in Italy.~   "
150297|NCT01599208|"~     The goal of the proposed research is to map the effects—in particular facilitation—of~     Transcranial Magnetic Stimulation (TMS) of the Medial Temporal Lobes (MTL) onto the~     processing of associative memory. TMS technology has the potential to selectively enhance~     functions mediated by areas in the temporal cortex, including the MTL, known to be the~     primary neuronal seat of episodic memory. By using this technology the investigators can~     further our understanding of theoretical models of human memory (specifically regarding the~     role of Recollection and Familiarity processes), and additionally, provide a possible route~     to the recovery of some of memory loss typically observed in the elderly—namely, memory for~     associations. Given the MTL's critical role in human memory and facilitation-inducing~     qualities of TMS, this research goal is to provide a nonintrusive tool to facilitate memory~     performance in young and elderly healthy participants.~   "
150298|NCT01599195|"~     The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the~     presence of bruit by using an acoustic signal to represent the bruit. This pilot study will~     address two questions: is there a detectable difference in recorded sound signal of carotid~     and femoral bruit when compared to sound signals captured when there is no bruit present; is~     the use of a visual recorded signal more accurate in identifying carotid and femoral bruit~     when compared to traditional auscultation with a regular stethoscope and ultrasound.~   "
150299|NCT01599182|"~     This study will work towards understanding the changes in your body (metabolism) that develop~     with treatment in prostate cancer. Hormonal therapies such as ADT often result in detrimental~     changes in body composition, including lean tissue loss and fat gains, compared to those~     patients receiving radiation therapy. These changes in body composition are linked to risk of~     diabetes and cardiovascular disease in survivorship. The investigators will be evaluating 50~     patients to primarily examine the changes in metabolism, nutrition, physical function and~     body composition at the end of treatment, 6 weeks and 6 months following the end of~     treatment. Patients will continue to be followed every 6 months for up to 5 years following~     the end of treatment. The investigators findings will provide a new perspective for future~     work and novel approaches in the treatment of prostate cancer.~   "
150300|NCT01599169|"~     The purpose of this study is to determine the efficacy and the tolerance of the food~     supplement B-Back®, containing α-casozepine, taurine, eleutherococcus senticosus and~     Extramel®, on the burnout syndrome.~   "
150301|NCT01599156|"~     The purpose of this study is to examine if the use of reflexology can alleviate chronic~     constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks~     of treatment and 12 weeks of follow up. Included in the study will be 40 men and women, 18~     years of age or older, which are able to comply with the study guidelines; Fewer than three~     spontaneous bowel movement per week; and one or more of the following symptoms/signs during~     more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1)~     straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. Exclusion~     criteria are: Loose or watery stool in the absence of laxative use for more than 25% of bowel~     movements during the 12 weeks preceding the trials; Mushy stool defined as a score of 6 on~     the Bristol Stool Form Scale for any SBM during the baseline period; Rome III criteria for~     the irritable bowel syndrome; History of pelvic-floor dysfunction; Neurological pathologies;~     Psychiatric conditions; Chronic use of medication with a gastro intestinal-activity.~   "
150302|NCT01599143|"~     Since it's introduction in 1979 at the University of Massachusetts Medical Center by Dr. Jon~     Kabat-Zinn, Mindfulness-Based Stress Reduction (MBSR) has become a respected adjunct to~     conventional treatment for patients suffering from many diverse chronic ailments. Three~     decades of research have documented it's benefits, but few papers have focused on identifying~     which particular aspect of MBSR directly correlates with it's degree of therapeutic efficacy.~     This study will use 7 well validated questionnaires to compare participants responses prior~     to, and following completion of an eight-week MBSR program at the North York General~     Hospital, as well as follow-up results at 1 month and 1 year post completion of the MBSR~     group.~   "
150303|NCT01599130|"~     For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but~     without HBeAg loss, switching to peg-interferon may increase the response rate. In the~     investigators study, patients were divided into two groups. In Group A, patients continued~     entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a~     monotherapy for 48 weeks, then followed up 24 weeks.~   "
150304|NCT01599117|"~     The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5~     inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with~     heart failure with preserved ejection fraction (HFpEF).~   "
150305|NCT01599104|"~     This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension~   "
150306|NCT01599091|"~     Porphyromonas gingivalis is one of the major bacteria involved in the formation and~     progression of chronic periodontitis. Pathogens invading the gingiva face the host's innate~     immune system at first and later on the acquired immune system which includes secreted~     antibodies and specialized cells. Although both the arms of the immune system are coordinated~     to overcome the infection, there are several known mechanisms which help pathogens as~     Porphyromonas gingivalis evade immunity. As a result, inflammatory mediators secreted by~     immune cells cause tissue damage and lead the inflammation process towards chronicity instead~     of clearing the pathogen. Up till recently most of the studies focused on the role of~     macrophages, dendritic cells and lymphocytes at the response to periodontal pathogenic~     bacteria while the role of fibroblasts (the most abundant cell in the connective tissue) was~     less examined. Fibroblasts are spindle shaped cells which have the ability to produce extra~     cellular matrix and respond to growth factors and cytokines. They are able to affect cells in~     the infected tissue and contribute to immune response efficiency. As known in the case of~     lymphocytes, fibroblasts also vary in subtypes, each differs in phenotype, immune~     interactions, extra cellular matrix production and destruction, migration abilities and so~     on. Two main fibroblasts subtypes in the oral cavity originate in the gingival tissue and the~     periodontal ligament anchoring teeth to the surrounding alveolar bone. Amongst the~     differences between the two are collagen production ability and receptors profile over the~     cell surface. Considering all that, the investigators aim to obtain and use periodontal~     ligament and gingival tissues removed anyways during common dental procedures in order to~     extract the different fibroblasts subtypes residing there and compare their response to~     Porphyromonas gingivalis.~   "
150307|NCT01599078|"~     The purpose of this study is to assess the safety and efficacy of administering~     intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following~     percutaneous revascularization to prevent restenosis.~   "
150308|NCT01599065|"~     The purpose of this study is to compare the two options for management of ICDs (internal~     cardioverter defibrillators) in patients undergoing procedures with electrocautery: (1)~     programming ICD therapies off, or (2) use of a magnet to suspend ICD therapies By comparing~     these two techniques the investigators hope to demonstrate the efficiency of using an ICD~     magnet protocol during perioperative management of patients undergoing electrocautery~     procedures. Secondary purposes are to gain further information on health care resources,~     incidence of EMI, handoff communications and to document lack of adverse events in either~     group.~      Primary objective will be: ICD therapy off times will be less with the use of a magnet~     protocol compared to an off-on protocol. Secondary objectives will be: (1) Healthcare~     resources (time and costs of skilled personnel) will be less using a magnet protocol compared~     to an off-on protocol, and (2) there will be no difference between adverse events in the~     magnet protocol compared to an off-on protocol. The incidence of EMI and number of handoff~     communications will be documented.~      The investigators hypothesis is that the number of minutes with ICD therapies off will be~     significantly less with magnet use. The investigators also expect health care resources to be~     less with magnet use compared to reprogramming.~   "
150371|NCT01598246|"~     This is a prospective chart review of all extubations in the pediatric intensive care unit.~     Over a one year period all extubations in the unit are to be recorded on a designated form~     and standard variables charted and compared. All data will be collected from the chart,~     retrospectively after the extubation event. Patients who fail extubation will be compared to~     those who succeed. We aim to identify factors which contribute to extubation failures in the~     unit, to come up with a unit specific extubation policy~   "
150309|NCT01599052|"~     There is ample evidence that children treated for a brain tumour (BT) often develop deficits~     in social and emotional functioning. The investigators wish to examine the cause of these~     deficits, i.e. the underlying neuropsychological deficit(s). The aim is to study impairment~     and developmental delay in social cognition (and related cognitive functions) caused by brain~     damage in patients treated for a BT in childhood as compared to a reference group of~     chronically ill children. If we can identify the specific deficits these patients experience,~     neuropsychological treatment and guidance can be developed to give patients the most optimal~     chances to live as normal as possible, to improve their quality of life (QoL) and to prevent~     them from developing depression and anxiety. Eventually, an intervention programme could be~     developed based on our results, to improve social, vocational and emotional QoL.~   "
150310|NCT01599039|"~     The goal of the study is to investigate the use of bio-impedance spectroscopy in the~     assessment of breast cancer related lymphoedema in patients operated with lumpectomy or~     mastectomy, axillary lymph node dissection and radiotherapy compared to inverse water~     volumetry. As a control group, patients with colon rectal cancer are used to compare~     volumetric and spectometric changes during follow-up.~   "
150311|NCT01599026|"~     Good glycemic control is superior to poor glycemic control in reducing risk of~     interventricular septum thickness among fetuses of diabetic mothers~   "
150312|NCT01599013|"~     This study is assessing the combination of well known cytotoxics with a novel anti-cancer~     agent that could be administered as monotherapy without renal toxicity in patients with renal~     impairment presenting with advanced or metastatic urothelial carcinoma previously treated~     with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio~     of the two most promising associations of cytotoxics including the novel therapeutic agent,~     vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.~   "
150313|NCT01599000|"~     In 2009, Papua New Guinea officially adopted artemether-lumefantrine (AL) as new national~     first-line drug for uncomplicated malaria. The principal purpose of this study is to measure~     the absolute effectiveness of AL when used under real-life clinical conditions, as compared~     to optimized in-vivo trial conditions. This question was raised by the National Department of~     Health in preparation for the country-wide roll-out of AL.~      The study is designed as a randomized controlled trial comparing two study arms. Patients in~     the effectiveness arm receive the first dose of AL under full supervision in the clinic;~     the following doses will be taken at home, as in real-life clinical practice and according to~     the new national treatment guidelines. Patients in the efficacy arm will receive all doses~     of AL as directly observed treatment in the clinic in order to establish the efficacy of the~     drug when used under ideal conditions.~      The study will enroll outpatients aged 6 months to 10 years with a history of fever and a~     positive rapid test for malaria. Patients meeting all enrollment criteria and providing full~     written informed consent by a parent/caretaker will be randomized into either of the two~     study arms. Patients in both arms will be followed up actively for 42 days. Patients in the~     efficacy arm will be scheduled for visits on days 0, 1, 2, 3, 7, 14, 28 and 42; patients in~     the effectiveness arm on days 0, 3, 7, 14, 28 and 42.~   "
150314|NCT01598987|"~     This study was designed to assess the evolution of renal function and to collect efficacy,~     safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric~     liver transplant recipients.~   "
150315|NCT01598974|"~     Acupuncture has been used for many years to help relieve pain. However, it is not clear how~     acupuncture works. We are doing this study to learn about the effects of different forms of~     acupuncture on chronic low back pain. We are interested in learning about brain activity~     during pain. We plan to look at brain activity at the beginning and the end of the study,~     after 6 sessions of acupuncture.~   "
150316|NCT01598961|"~     There have been reports of monitoring LSR during MVD surgery helps predicting the clinical~     outcome of MVD.However, there have been no evidence of which degree of partial neuromuscular~     blockade should be performed or no neuromuscular blockade could be performed during LSR~     monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of~     different degree of partial neuromuscular blockade, including no neuromuscular blockade on~     the LSR monitoring for MVD surgery.~   "
150317|NCT01598948|"~     Elevated LDL-cholesterol is a major risk factor for heart disease. In patients with heart~     disease LDL-cholesterol should be lowered to levels below 70 mg/dl to prevent progression of~     disease. In most patients life style modification together with lipid lowering drug therapy~     is sufficient to achieve this goal. In some patients with severe forms of~     hypercholesterolemia, this may not be sufficient to reach goals and regular lipid apheresis~     (a costly and time intensive form of therapy) may be performed. Mipomersen is a new drug~     (apoB antisense oligonucleotide) that can lower LDL-cholesterol even in the most severe forms~     of LDL-hypercholesterolemia by 25-47%. It is unknown whether and to what extent mipomersen~     can decrease LDL-cholesterol in patients treated with regular apheresis. Phase 1 of the study~     will test how 6 months of weekly therapy with mipomersen affects LDL-cholesterol in patients~     with severe LDL-hypercholesterolemia treated with regular apheresis. Phase 2 will test in how~     many patients this will result in a meaningful reduction of apheresis time, apheresis~     frequency or if apheresis can be stopped completely.~   "
150318|NCT01598935|"~     Today, there is an important lack of knowledge on the effects of dietary protein on protein~     metabolism after physical activity in children. Here, the investigators will measure changes~     in whole body protein metabolism using minimally invasive techniques and stable isotope~     methodology at rest and after physical activity with the intake of milk protein.~   "
150319|NCT01598922|"~     The purpose of this study is to understand the effectiveness of a ten-week internet-based~     cognitive behavioral therapy (iCBT) treatment on improving depressive symptoms, coping and~     resilience skills, and cognitive processing.~   "
150320|NCT01598909|"~     Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the~     field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use~     Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent~     study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical~     outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment~     postoperatively will reduce the development of ecchymosis and improve outcome.~   "
150372|NCT01598233|"~     The purpose of this study is to evaluate the effects of intragastric balloon on bone,~     metabolic and respiratory parameters in 50 patients with metabolic syndrome.~   "
150321|NCT01598896|"~     Cannabis use disorders are an important public health problem in the United States, but no~     effective pharmacotherapies are available to treat these disorders. People with schizophrenia~     are more likely than healthy people to abuse cannabis. Cannabis use may worsen clinical~     outcomes in this group, making the identification of pharmacotherapy to treat cannabis~     dependence in those with schizophrenia important. The investigators intend to test the~     combination of dronabinol, a cannabinoid agonist, and the α2-adrenergic agonist clonidine,~     for cannabis dependence in subjects with schizophrenia. The combination of dronabinol and~     clonidine may alleviate cannabis withdrawal symptoms while allowing treatment-seeking~     outpatients to benefit from medical management (MM) sessions when they are trying to stop~     using cannabis. The investigators propose to assess the relationship of dronabinol and~     clonidine, when added to MM, on cannabis use patterns in cannabis-dependent patients with~     schizophrenia.~      Hypothesis: The investigators predict that combination pharmacotherapy of dronabinol and~     clonidine will significantly reduce cannabis use compared to those receiving placebo.~   "
150322|NCT01598883|"~     This study will explore altered heparin responsiveness (AHR) in cardiac surgical patients~     undergoing cardiopulmonary bypass (CPB) requiring systemic anticoagulation with heparin. The~     investigators will evaluate the hypothesis that AHR may be directly related to, modulated or~     mediated by interactions between heparin, antithrombin (AT), the heparin-AT complex, and one~     or more acute phase proteins. The investigators are particularly interested in identifying~     patients with true heparin resistance, that is, patients who demonstrate AHR even after~     antithrombin-replenishment in the presence of an adequate systemic dose of heparin.~   "
150323|NCT01598870|"~     The study is aimed to revise the current criteria for the diagnosis of spontaneous bacterial~     peritonitis and the decisional thresholds to start treatment. The accuracy of current~     diagnostic tests will be compared with that of new tests, which could potentially become more~     accurate reference standards. This could lead to the definition of a more accurate and~     effective diagnostic algorithm.~   "
150324|NCT01598857|"~     The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when~     taken with methotrexate in the induction of remission in ANCA-Associated Small Vessel~     Vasculitis.~   "
150325|NCT01598844|"~     The purpose of this registry is to observe longterm performance and safety of the JenaValve~     TAVI system, in routine medical and everyday conditions.~   "
150326|NCT01598831|"~     The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis~     can decrease mortality.~   "
150327|NCT01598818|"~     The aim of this study is to test the efficacy of the First-Sight refractive kit designed to~     provide refractive correction of simple hyperopia, myopia and astigmatism with~     autorefraction.~   "
150328|NCT01598805|"~     Now, after a cluster randomized controlled trial, eAlerts providing evidence-based guidelines~     on venous thromboembolism prophylaxis will be rolled out and evaluated hospital-widely.~   "
150329|NCT01598792|"~     It is the investigators intention to investigate whether a specially designed vaccine, based~     on a genetically modified strain of the bacterium Listeria monocytogenes and called~     ADXS11-001 is safe to use and is able to boost the immune system of patients presenting with~     Human Papilloma Virus (HPV) associated oropharyngeal cancer (OPSCC). It is hoped that the~     vaccine will boost the immune system so that immune cells with cell killing properties are~     able to attack any cancer cells remaining after the patients have been treated. However, the~     vaccine is so novel the investigators are not sure whether it is able to do this and before~     they can answer that question in a larger group of patients they need to make sure that the~     vaccine is safe to use and has some effect on the immune system in the patients for whom they~     intend its ultimate use. In a previous study, patients with incurable cervix cancer which is~     caused by the same virus, were vaccinated with ADXS11-001. Although all patients vaccinated~     experienced flu-like symptoms, patients tolerated the vaccine well with no patient suffering~     long term adverse effects of vaccination. However, because the patients and cancer type was~     so different in this earlier study, the investigators need to test whether ADXS11-001 is also~     safe in patients with HPV associated OPSCC. That said, the earlier study guided the dosing~     schedule for the current study and patients entering the REALISTIC trial will receive lower~     doses than those administered to patients in the earlier cervix cancer study. It is hoped~     that by doing this, patients will experience fewer side effects of vaccination without~     reducing the chances of stimulating the immune system.~   "
150330|NCT01598779|"~     The summary of this study is to know which HPV types are present in genital warts in~     Argentinean population.~   "
150331|NCT01598766|"~     This study is a feasibility study to evaluate new technology to improve the MRI experience,~     with coils, sequences and software. Patients from the Principle Investigator's exam schedule~     are given the opportunity to participate in this study is their MRI exam is appropriate for~     the specific coil, sequence or software being evaluated. If they agree, they can receive~     their MRI exam with the new coil, sequence or software instead of the standard one.~   "
150332|NCT01598753|"~     This is a randomized control study that involves a combination of a drug treatment,~     behavioral health, and placebo controls.~      Some participants will receive a medication approved by the Food and Drug Administration for~     treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive~     an inactive pill, called a placebo. There will also be 2 different types of behavioral health~     treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have~     been recommended for the treatment of patients with FM by the American Pain Society.~      There are 4 possible study treatment combinations:~        1. Tramadol + CBT,~        2. Tramadol + HE,~        3. Placebo + CBT,~        4. Placebo + HE.~      Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there~     have been no studies that have evaluated the combination of medication and a behavioral~     health treatment. The primary purpose of this study is to compare the benefits of the 4~     combinations listed.~   "
150333|NCT01598740|"~     The purpose of this study is to determine the effects of CLP, with and without~     spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic~     kidney disease.~   "
150373|NCT01598220|"~     The purpose of this study is to determine whether computer-assisted cognitive remediation~     therapy is effective in the treatment of cognitive deficits in schizophrenia.~   "
150334|NCT01598727|"~     Hypothesis: Intraoperative use of near infrared fluorescent imaging technology and detection~     of Methylene Blue fluorescence will improve outcomes following thyroid and parathyroid~     surgery.~      Aims: The aims of this phase of the study are to determine the feasibility of using near~     infrared fluorescent technology in the detection of parathyroid tissue and its~     differentiation from adjacent soft tissue during surgery on parathyroid glands.~      Objectives of the phase I study:~        1. To familiarise surgical teams with the intraoperative use of the 'Fluobeam(TM)' device~          (Fluoptics).~        2. To understand the patterns (onset, intensity and duration) of fluorescent staining of~          normal parathyroid glands, thyroid glands and other soft tissue structures encountered~          during parathyroidectomy.~      Further research:~      This will be followed by a phase II study during which fluorescent imaging will be used in~     conjunction with intraoperative incremental dose of IV methylene blue in both thyroid and~     parathyroid surgery. Phase II will enable us to develop a protocol for the use of a minimum~     possible dose of MB for the identification of parathyroid glands. This will then be tested in~     the pilot phase of a randomized clinical trial.~   "
150335|NCT01598714|"~     This study compares patient satisfaction in terms of pain relief, mobility and ease of use~     between 3 commonly used types of post-surgical footwear. This study randomises patients who~     participate into one of 3 groups of footwear, namely Darco, Podalux or standard dressing~     shoe. Number of patients enrolled is determined by power calculation. Patients complete a~     single, simple previously validated questionnaire the MOXFQ (Manchester-Oxford Foot~     Questionnaire) at their 6 week follow-up appointment and statistical differences between the~     group are calculated using a significance level of p<0.05. This study will help us determine~     the best foot-wear to offer the investigators post-surgical patients.~      This study will form original research.~   "
150336|NCT01598701|"~     The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an~     effective adjunct therapeutic agent in patients undergoing craniotomy.~   "
150337|NCT01598688|"~     The purpose of this study is to verify whether differences exist in cyclosporine levels~     between the samples collected through peripheral venous access, the catheter line used to~     infuse the drug and the line not used for infusion immediately after interrupting the drug~     infusion or five minutes after the interruption.~   "
150338|NCT01598675|"~     Many of the 780,000 people affected by stroke each year are left with slow, asymmetric~     walking patterns. The proposed project will evaluate the effectiveness of two competing motor~     learning approaches to restore symmetric gait for faster, more efficient, and safer walking.~   "
150339|NCT01598662|"~     This is randomized controlled trial designed for pregnant women who deliver vaginally at the~     University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted~     for postpartum contraception. After informed consent is obtained, eligible study participants~     will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10~     minutes of delivery of the placenta following a normal vaginal delivery. The investigators~     seek to determine the expulsion rate and complication rate in subjects with IUD immediately~     after placental delivery compared to insertion at six weeks postpartum or later. The~     investigators hypothesize that immediate placement safe and has an acceptably low expulsion~     rate to merit earlier placement in the indigent population.~   "
150340|NCT01598649|"~     The objective of the study is to elucidate the effects of lupin protein (Lupinus~     angustifolius Boregine) as part of a mixed diet on cardiovascular risk factors and to clarify~     the role of arginine, one of the most abundant amino acids in lupin protein.~   "
150341|NCT01598636|"~     The Lateral Tibial Tunnel technique is a new concept in Anterior Cruciate Ligament (ACL)~     surgery. In this technique a tibial tunnel is drilled from the antero-lateral side of the~     tibia towards the ACL footprint. This technique allows the surgeon to deal with bone stock~     problems in the antero-medial part of the tibia as often encountered in ACL revision surgery.~     In ACL revision surgery it is often impossible to perform a one-stage revision surgery~     procedure due to bone stock deficiency in the antero-medial side of the tibia. It is~     hypothesized that the Lateral tibial tunnel technique allows the surgeon to perform a~     one-stage procedure instead of a two stage procedure. Furthermore the lateral tibial tunnel~     technique allows better graft fixation in two-stage ACL revision surgery. Several~     biomechanical studies proved biomechanical superiority of the new technique compared to the~     classical technique.~   "
150342|NCT01598623|"~     The objectives of the study are:~        1. To evaluate the effect of OT compared to placebo, as add-on to anti-psychotics, on~          social functioning in schizophrenia.~        2. To evaluate the effect of socially oriented CBT administered to patients immediately~          after they receive OT, compared to patients who receive OT with not-socially oriented~          CBT, and compared to patients who receive socially oriented CBT without OT. The~          investigators hypothesize that OT and socially oriented CBT will have a synergistic~          effect, and will be better than OT or CBT alone.~        3. Use a detailed, in depth analysis of social interaction to assess these putative effects~          of OT. The investigators hypothesize that the use of this analysis will show larger~          treatment effects of OT than previously shown in less sensitive assessments, such as~          PANSS.~        4. To assess the effect of epigenetic status on response to OT. The investigators~          hypothesize that epigenetic variants associated with lower OT plasma levels will be~          associated with greater response to OT treatment.~        5. To assess in the relationships between levels of salivary OT and vasopressin, and social~          interactions in schizophrenia.~        6. To assess in the relationships between levels of salivary OT and vasopressin, and~          response to OT treatment.~   "
150343|NCT01598610|"~     The purpose of this study is to demonstrate that untrained subjects who have diabetes can~     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose~     results.~   "
150388|NCT01598025|"~     Approximately 30% of patients who are candidates for bone marrow transplants do not have an~     HLA-matched, or close to matched, donor available. For this reason, doctors have been testing~     ways to make transplants from HLA-partially matched donors as safe and effective as~     transplants from HLA-matched donors.~      This study is being done to test the safety and the treatment results of a specific kind of~     transplant. In this transplant, blood from two donors will be used. Each donor will share one~     half of your HLA type. Blood from both donors will be transplanted at the same time.~   "
172705|NCT01304550|"~     This is a retrospective comparison of hemoglobin measurements obtained by arterial blood gas~     analysis and the Masimo Continuous Hemoglobin Monitor~   "
150344|NCT01598597|"~     This pilot, non-interventional, observational, Web-based, prospective cohort study is~     designed to collect self-reported safety and effectiveness and genetic data from subjects~     with locally recurrent breast cancer (BC) or metastatic breast cancer (MBC), metastatic~     colorectal cancer (MCRC), metastatic non-squamous non-small cell lung cancer (MNSCLC),~     recurrent glioblastoma (RGBM), or metastatic renal cell cancer (MRCC) in the United States~     who have been previously treated with Avastin (bevacizumab). The cohort will be composed of~     male and female subjects who have been diagnosed with locally recurrent BC or MBC, MCRC,~     MNSCLC, RGBM, or MRCC who have received treatment with bevacizumab in combination with~     chemotherapy, which started prior to or up to 31 December 2012. Participants will be~     self-referred to this study. They will be recruited online via a number of sources, including~     through the involvement of patient advocacy groups, social media tools, traditional media,~     physicians, and events to raise awareness of this study. After appropriate informed consent~     and authorization are obtained, data will be collected directly from subjects in an online~     survey. Participants will be contacted electronically to complete quarterly follow-up~     surveys. The follow-up period will be 1 year from responding to the baseline survey. DNA~     collection will be performed as part of this study. DNA will be extracted from saliva, which~     will be provided by the subject utilizing a collection kit sent to the participants for~     at-home use.~   "
150345|NCT01598584|"~     Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression~     has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a~     high risk increase weight. So the investigators assume Mirtazapine would not only improve the~     anxiety and depression of metastasis pancreas cancer but also would improve the appetite of~     such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve~     the quality of life in advanced pancreatic cancer which is of short survival.~   "
150346|NCT01598571|"~     Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer~     dose.~   "
150347|NCT01598558|"~     Rituximab is an antibody targeted against the CD20 antigen found primarily on B-cells.~     Therefore, an imaging agent targeting CD20 expression may provide a more accurate evaluation~     of extent of disease and response to therapy than the current standard of care, F-18 FDG~     PET/CT.~      The main purpose of the study is to investigate a new PET/CT imaging probe for detection and~     follow up of lymphoma. Following are the 3 aims of the study: a) Phase I testing in lymphoma~     patients of Cu-64 labelled Rituxan for defining normal tracer biodistribution, stability,~     pharmacokinetics and radiation dosimetry; b) comparison of Cu-64 Rituxan and F-18 FDG PET/CT~     in lymphoma patients; c) evaluation of changes in uptake of Cu-64 Rituxan in response to~     rituximab-based treatment in CD20-positive B-cell NHL~   "
150348|NCT01598545|"~     This study will investigate the dose of hydromorphone which will relieve the pain of women~     following a cesarean section when delivered directly in the area around the spinal cord~     (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal~     hydromorphone that results in a pain score of less than 3 out of 10 12 hours after~     intrathecal injection in 50% of women. Secondary objectives include determining the average~     amount of time patients obtain pain relief after injection. Other secondary objectives~     include determining the frequency and severity of side-effects associated with intrathecal~     administration of hydromorphone, including: bradycardia, hypotension, respiratory depression,~     apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and~     delivery for planned cesarean section desiring will be consented for the study. The starting~     dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method~     of statistical analysis will be used, meaning that each subsequent dose will be dependent~     upon the result obtained from the prior dose - ergo, if the initial subject has pain relief,~     the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have~     pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.~      After the intrathecal injection is given, patients will undergo their cesarean section. The~     patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire.~     The patient's medical record will be reviewed to determine when she first requested~     supplemental pain medication. A pain score of less than three will be a positive result. A~     pain score of three or greater will be a negative result. Blood pressure, heart rate,~     arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be~     assessed.~   "
150349|NCT01598532|"~     The purpose of the study is to investigate whether transcranial, high-intensity LED placed on~     the scalp can improve working memory in people who have sustained a concussion with lingering~     effects or a mild brain injury.~   "
150350|NCT01598519|"~     The primary aim of this study is to examine whether a school-based suicide intervention is~     effective in reducing suicide related risk factors in a population of middle and high~     students. It hypothesized that receiving the intervention will reduce the severity of suicide~     related risk factors such as depression, hopelessness, suicidal behaviors and increasing~     protective factors such as social support, self esteem, suicide knowledge and attitude and so~     on, as compared to the control group.~   "
150351|NCT01598506|"~     This study will investigate the dose of hydromorphone which will relieve the pain of women in~     labor when delivered directly in the area around the spinal cord (i.e., intrathecal~     injection). The primary objective is to determine the dose of intrathecal hydromorphone that~     results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection~     in 50% of women. Secondary objectives include determining this dose at five and ten minutes~     after injection. Thirty women admitted to labor and delivery for planned vaginal delivery~     desiring epidural placement will be consented for the study. The starting dose of intrathecal~     hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical~     analysis will be used, meaning that each subsequent dose will be dependent upon the result~     obtained from the prior dose - ergo, if the initial subject has pain relief, the second~     subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain~     relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.~      After the intrathecal injection is given and the epidural is placed, visual analogue pain~     scores will be assessed 60 minutes following injection. A pain score of less than three will~     be a positive result. A pain score of three or greater will be a negative result. Blood~     pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will~     also be assessed.~   "
150389|NCT01598012|"~     Ayurved Siriraj Prasaplai is a Thai traditional herbal drug for pain treatment. Mostly it was~     used for antipain during menstruation or dysmenorrhea. This drug has been described by~     alternative medical doctor for treatment of primary dysmenorrhea for more than 10 years and~     showed clinical satisfied response. From review about this agent, it does not have clinical~     trial to prove its efficacy. So the author produce this research to study in efficacy of~     Ayurved Siriraj Prasaplai.~   "
150390|NCT01597999|"~     This study examines the additional benefits of magnetic resonance imaging (MRI) with Gadovist~     in early breast cancer with poor prognostic features.~   "
150352|NCT01598493|"~     Background:~      Bio-medical Carbon Technology (BCT) Antimicrobial Dressing, a novel advanced wound dressing~     invented by Bio-medical Carbon Technology Co., Ltd., Taiwan, consists principally of~     activated carbon fiber impregnated with silver particles. The highly porous nature and the~     large specific surface area of activated carbon fiber provide a tremendous adsorptive~     capacity for toxins, wound degradation products, and odors. Furthermore, far infrared ray~     emitted from activated carbon fiber accelerates blood circulation to stimulate tissue~     regeneration. Silver ions efficiently eliminate a broad spectrum of bacteria through~     penetrating the cell wall of bacteria and denaturing essential proteins. This clinical trial~     investigates wound healing effects of BCT Antimicrobial Dressing on deep dermal burn~     patients.~      Aim:~      To investigate wound healing effects of BCT Antimicrobial Dressing on deep dermal burn.~      Methods:~      This trial is expected to recruit 30 eligible subjects. After hospitalized patients are~     diagnosed as deep dermal burn, the procedure of Informed Consent is conducted by the project~     investigator. As long as the patient agrees to join this clinical trial and signs the~     Informed Consent, two separate areas of 25 cm2 in the same anatomic site are chosen and~     distributed to the control and research groups respectively by coin flipping. The wound in~     the research group is first cleansed with normal saline and then applied with BCT~     Antimicrobial Dressing and covered by sterile gauze, and dressings will be changed every 3~     days (counting from the day applied BCT dressings: Day0, 3, 6, 9, 12, 15……etc.) until the~     wound is healed. Flamazine is applied on the wound in the control group instead and then~     covered with sterile gauze, and the frequency of dressing change is daily until the wound is~     recovered. The healed and non-healed area of wound is recorded and photographed every 3 days,~     and the wound color and infection are also evaluated. On Day 12 and Day 21, compare the ratio~     of healing and non-healed areas in the control and research groups, and the ending point is~     set on the 21st day.~      Statistics Analysis:~      Paired Student's t-test will be performed to analyze the clinical data by comparing the~     difference of the healing percentage, the healing rate, the infection rate, and the frequency~     of dressing change. It is statistically significant when P<0.05.~   "
150353|NCT01598480|"~     Background:~      Bio-medical Carbon Technology (BCT) Antimicrobial Dressing, a novel advanced wound dressing~     invented by Bio-medical Carbon Technology Co., Ltd., Taiwan, consists principally of~     activated carbon fiber impregnated with silver particles. The highly porous nature and the~     large specific surface area of activated carbon fiber provide a tremendous adsorptive~     capacity for toxins, wound degradation products, and odors. Furthermore, far infrared ray~     emitted from activated carbon fiber accelerates blood circulation to stimulate tissue~     regeneration. Silver ions efficiently eliminate a broad spectrum of bacteria through~     penetrating the cell wall of bacteria and denaturing essential proteins. This clinical trial~     investigates wound healing effects of BCT Antimicrobial Dressing on superficial dermal burn~     patients.~      Aim:~      To investigate wound healing effects of BCT Antimicrobial Dressing on superficial dermal~     burn.~      Methods:~      This trial is expected to recruit 30 eligible subjects. After hospitalized patients are~     diagnosed as superficial dermal burn, the procedure of Informed Consent is conducted by the~     project investigator. As long as the patient agrees to join this clinical trial and signs the~     Informed Consent, two separate areas of 25 cm2 in the same anatomic site are chosen and~     distributed to the control and research groups respectively by coin flipping. The wound in~     the research group is first cleansed with normal saline and then applied with BCT~     Antimicrobial Dressing and covered by sterile gauze, and dressings will be changed every 3~     days (counting from the day applied BCT dressings: Day0, 3, 6, 9, 12, 15……etc.) until the~     wound is healed. Flamazine is applied on the wound in the control group instead and then~     covered with sterile gauze, and the frequency of dressing change is daily until the wound is~     recovered. The healed and non-healed area of wound is recorded and photographed every 3 days,~     and the wound color and infection are also evaluated. On Day 12 and Day 21, compare the ratio~     of healing and non-healed areas in the control and research groups, and the ending point is~     set on the 21st day.~      Statistics Analysis:~      Paired Student's t-test will be performed to analyze the clinical data by comparing the~     difference of the healing percentage, the healing rate, the infection rate, and the frequency~     of dressing change. It is statistically significant when P<0.05.~   "
150354|NCT01598467|"~     The purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy~     for repair of pelvic organ prolapse in high volume european centers.~   "
150355|NCT01598454|"~     This study will be carried out in children with diagnosis of cancer with tumors known to~     express N-glycolylated gangliosides. The disease must be resistant to conventional therapy.~     The acute toxicity and immune response will be evaluated.~      The expression of N-glycolylated gangliosides in tumors has previously been investigated in~     the tumor sample bank at this Hospital. The expression of N-glycolyl GM3 was shown in~     neuroblastoma, Ewing's sarcoma, Wilm's tumor and retinoblastoma.~      Gliomas and the aforementioned tumor types have a very bad prognosis when conventional~     treatment is ineffective.~      New therapeutic strategies have thus been examined, and several immunotherapeutic approaches,~     including dendritic cell vaccines, peptide vaccines and anti-idiotype vaccines are currently~     being assessed.~      Racotumomab is an anti-idiotype antibody capable of inducing anti-N-glycolyl GM3 antibodies~     in patients with melanoma, breast cancer and lung cancer.~      Dose escalation studies have shown the safety of racotumomab in the 0.5 to 2 mg dose range.~     The 1 mg dose level was selected for the ensuing clinical studies.~      This clinical trial in children involves three dose levels: 0.15 mg, 0.25 mg and 0.4 mg,~     owing to the difference in body surface between an adult (1.73 sq. m in average) and the~     candidate population for this study (0.55 to 0.7 sq. m).~   "
150356|NCT01598441|"~     This study was designed to investigate treatment of postoperative pulmonary hypertension by~     iloprost inhalation in children with congenital heart defects. It was a controlled~     single-blind randomized multi-center prospective study in order to explore the efficacy of~     this method in the treatment and prevention of pediatric pulmonary hypertension after~     corrective open-heart surgery for congenital heart defects.~   "
150357|NCT01598428|"~     -  The purpose of this study is to evaluate effects of anterior capsule polishing on~          effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by~          measuring anterior chamber depth (ACD)~        -  patients with bilateral age-related cataract undergo bilateral uneventful cataract~          surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable~          IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd~          Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was~          measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical~          Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was~          defined as the root mean square (RMS) of the change in ELP at each visit.~   "
150358|NCT01598415|"~     Study objectives:~        -  Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety,~          tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.~        -  Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and~          tolerability of a single intra-articular dose of SAR113945.~   "
150359|NCT01598402|"~     Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have~     (during and shortly after this treatment) a high risk of developing pneumonia by aspiration.~     This pneumonia is often associated with a hospital admission and affects the quality of life.~      The purpose of the study, is to determine whether prophylactic antibiotics may decrease the~     development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia~     are already~   "
150360|NCT01598389|"~     The purpose of this study was to compare weight-discordant siblings in eating in the absence~     of hunger, caloric compensation, and the quality of their habitual diet. The investigator~     hypothesized that, within families and controlling for age differences, overweight and obese~     siblings would show greater eating in the absence of hunger, poorer caloric compensation, and~     poorer diet quality (e.g., increased percent of energy from fat and caloric beverages)~     compared to normal-weight siblings.~   "
150361|NCT01598376|"~     Objective~      To investigate the tissue reaction produced by implanted polyglactin suture material in~     normal human skin and to determine the effect of suture gauge on this response.~      Design~      A prospective, double blind, randomized clinical trial using a novel ethical study design.~     Both the patient and clinician analyzing the histology were blinded to the suture gauge used.~      Participants~      A total of 42 consecutive patients presenting to an oculoplastic clinic with involutional~     entropion and horizontal eyelid laxity, who provided written consent to participate, were~     enrolled in the study.~      Intervention~      Patients were randomly allocated to 5/0 or 7/0 Vicryl™ test suture groups. Patient symptoms~     were alleviated during the wait for definitive surgery by the placement of temporary eyelid~     everting sutures including a test suture. After 28 days, entropion correction was achieved by~     a Quickert procedure which includes excision of an eyelid wedge. Histological analysis was~     carried out, blind to the suture gauge used, on the excised eyelid containing the test~     suture.~      Main outcome measure~      Defined histological parameters of suture-related granulomas were measured at multiple~     levels. Data included granuloma outer diameter, central cellular diameter, giant cell number~     and area of fibrous coat (calculated from the coat diameter and thickness at multiple levels)~     and a statistical comparison made between the 5/0 and 7/0 suture gauge groups.~   "
150362|NCT01598363|"~     The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the~     pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant~     administration of bardoxolone methyl with digoxin or rosuvastatin.~   "
150363|NCT01598350|"~     On average, Down syndrome (DS) occurs once in every 700 live births and results in life-long~     disability and increased risk for comorbidities.1 Individuals with DS are also susceptible to~     secondary physical impairments and limitations as a result of complications associated with~     joint hypermobility, hypotonicity, and increased ligamentous laxity. Secondary impairments~     such as pes planus (flat feet), weakened muscles, bony abnormalities and arthritis may lead~     to painful joints and feet. Additionally, children with DS often manifest deviations in gait~     as a result of physical limitations imposed by orthopedic and muscular deficiencies that may~     lead to decreased postural stability. These secondary losses in function, which exacerbate~     disabilities, may be preventable with the use of appropriate early interventions aimed at~     correcting abnormal joint alignment. Research exploring effective physical therapy~     interventions for adults and children with DS is currently very limited. However, the use of~     orthotic devices to support lax ligaments and hypotonic muscles, which are common~     manifestations of DS, is one accepted method of intervention for children within this~     population. Orthoses are variable in structure and the degree of support provided to the foot~     and ankle also differ between foot orthoses (FOs) and supramalleolar orthoses (SMOs).~     Previous studies have supported the effectiveness of orthoses on improving ankle and foot~     alignment, as well as gait parameters. However, disagreement currently exists concerning~     which type of orthotic device is most beneficial for the population of children with DS.~     Children with DS express variable degrees of joint laxity and hypotonicity, as well as~     differences in the severity of specific alignment abnormalities such as excessive pronation~     or calcaneal eversion.6 Current literature is insufficient for explaining differences in the~     benefits provided by FOs and SMOs and the specific indications for their use in children with~     DS is unclear.~      Study Aims This study will demonstrate the differences in structural outcomes provided by FOs~     and SMOs and develop specific criterion for matching individuals of differing orthopedic~     impairments with the most beneficial orthotic device.~   "
150364|NCT01598337|"~     This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel)~     on the incidence of early and intermediate graft patency after CABG.~   "
150365|NCT01598324|"~     This is an ancillary study to a clinical trial that is being conducted at Massachusetts~     General Hospital. Investigators at MGH are conducting a clinical trial to test the efficacy~     of ziprasidone together with escitalopram for treatment-resistant depression (NCT00633399).~     This observational study will involve magnetic resonance scans to examine brain chemistry~     (neurotransmitter levels), brain activity, and functional connections between brain regions~     before and after participating in the trial. The neurotransmitters of interest are glutamate,~     glutamine, and GABA. Comparisons will be made between individuals who receive ziprasidone and~     individuals who receive an inactive placebo. Differences between participants who respond to~     standard antidepressants and those who require additional medication will also be examined.~     All participants will have a baseline magnetic resonance scan before starting medication. The~     second scan will be after 8 weeks of escitalopram treatment for those who respond or~     following 8 weeks of escitalopram plus ziaprasidone or placebo (16 weeks after starting) for~     those who do not respond to escitalopram alone. Participants will complete standard rating~     scales for depression at each visit.~   "
150366|NCT01598311|"~     A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will~     participate in this study; participants will receive either oral vancomycin or CB-183,315 in~     a blinded fashion. Treatment will last for 10 days and participants will be followed up for~     at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well~     CB-183,315 treats CDAD as compared to vancomycin.~   "
150367|NCT01598298|"~     RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone~     therapy. It is not yet known whether duloxetine hydrochloride is more effective than a~     placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.~      PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works~     compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage~     breast cancer receiving hormone therapy.~   "
150368|NCT01598285|"~     GEI-BEV-2011-01 is an Observational multicenter study. The study, involving 200 (100~     non-responders and 100 best responders) metastatic breast cancer patients, will search for~     specific genetic variants (SNPs) and miRNA signatures associated with bevacizumab response.~     Only patients suffering from metastatic (disseminated at the time of diagnosis) breast~     cancer, treated with bevacizumab, will be included.~        1. -To identify genetic variants as bevacizumab response predictors in metastatic breast~          cancer~        2. To identify miRNA signatures in whole blood as bevacizumab response predictors in~          metastatic breast cancer patients.~      The main endpoint will be progression-free survival (PFS)~      The duration of the study will be approximately 18 months~   "
150369|NCT01598272|"~     Determine the effects of 8 week Investigational Supplement on cellular detoxification and~     gene expression profiles~   "
150370|NCT01598259|"~     The specific aims of this investigation in children during burn rehabilitation include 1.) to~     determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.)~     investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and~     3.) develop a new methodology specific for burn patients that accurately screens for the~     presence of intrinsic dyssomnia.~   "
150391|NCT01597986|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.~   "
150374|NCT01598207|"~     Background: Noncardiac chest pain (NCCP) affects 200,000 new cases annually in USA. It is~     associated with poor quality of life and high health care expenditure of 8 Billion Dollars a~     year.~      Gastroesophageal Reflux Disease(GERD), esophageal motility disorders, and psychological~     issues may cause NCCP.~      The mechanism(s) for pain continue to be explored and include central and peripheral~     hypersensitivity, and mechanophysical abnormalities. Treatment of NCCP has focused on~     relieving visceral hypersensitivity through pain modulators, such as tricyclics, trazodone,~     or adenosine receptor antagonist, theophylline. Typically, only 40-50 % respond and clearly~     there is a large unmet therapeutic need.~      Cannabis is felt to be beneficial for vomiting, diarrhea and intestinal pain. The main~     component of Cannabis acts through specific receptors, that are located primarily on central~     and peripheral neurons (including the enteric nervous system) and myenteric plexus where they~     modulate neurotransmitter release. Activation of these receptors reduces excitatory enteric~     transmission and may improve esophageal hyperreactivity and hypersensitivity, the hallmarks~     of NCCP.~      STUDY PROTOCOL: The investigators will randomize 40 subjects with non-cardiac, non-reflux~     chest pain to receive dronabinol (5 mg Bid), or placebo for 4 weeks. Chest pain symptoms and~     esophageal sensorimotor properties will be assessed at baseline and at 4 weeks using symptom~     diary and impedance planimetry. The primary outcome measure will be the frequency of chest~     pain episodes. Secondary outcome measures include improvement in esophageal sensory~     thresholds, reduced reactive contractions, frequency, amplitude, area under the curve, and~     global improvement of symptoms.~      HYPOTHESIS: Cannabinoids decrease esophageal hypersensitivity and ameliorate chest pain in~     NCCP patients, when compared to placebo.~      AIM: To perform a randomized double blind study to investigate the effects of Dronabinol, a~     CB1 and CB2 agonist, in the treatment of patients with NCCP and examine its mechanism of~     action.~   "
150375|NCT01598194|"~     The goal of this clinical research study is to compare the performance of a newly available~     needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles~     to see which needle gives better diagnostic information for pancreatic lesions.~   "
150376|NCT01598181|"~     The purpose of this study is to investigate Transcranial Direct Current Stimulation as~     treatment method for pain in fibromyalgia.~   "
150377|NCT01598168|"~     Heparin is an anticoagulant (blood thinner) that is commonly used to treat patients with~     heart attacks and patients with blood clots in their legs or lungs (venous thrombosis). Some~     patients develop an allergic reaction to heparin, a condition called heparin-induced~     thrombocytopenia (HIT). HIT makes blood clot, which is the opposite of what heparin was~     designed to do. These blood clots can lead to heart attacks, strokes, limb amputations, and~     death. The objective of this 200 patient study is to determine if a new blood thinner called~     rivaroxaban (Xarelto) can be used to treat HIT. Rivaroxaban can be taken by mouth, does not~     require blood testing, and had a low risk of bleeding when it was used to treat blood clots~     in other clinical trials. If this study shows that rivaroxaban can be used to treat HIT,~     there will be two very important benefits. For patients with HIT, the benefit will be having~     a safe, and easy-to-use drug to protect them from developing further life or limb-threatening~     blood clots. For the Canadian health care system, the benefit will be having a drug that is~     much less expensive than the drugs currently used to treat HIT.~   "
150378|NCT01598155|"~     Seventy patients will be previously treated for moderate-to-severe periodontitis according to~     their individual needs. Thirty days after completion of periodontal treatment, these patients~     will be randomized to one of the following groups of periodic preventive maintenance (PPM):~     G1 - performed only control supragingival; G2 - performed supra and subgingival control (when~     necessary).~      The maintenance consultations will be scheduled every 3 months for 24 months. The hypothesis~     is that the effect of the supragingival control (conducted over 24 months) will be similar to~     the effect of the supra- and subgingival control combined, above the restoration and~     progression of periodontitis.~   "
150379|NCT01598142|"~     The single-operator wire-guided cannulation technique doesn't require an experienced~     assistant and precise coordination between the assistant and endoscopist.~   "
150380|NCT01598129|"~     The purpose of the study is to investigate the safety and the recommended dose for later use~     of an oncolytic adenovirus CGTG-102 in combination with low-dose oral cyclophosphamide in the~     treatment of advanced cancers.~   "
150381|NCT01598116|"~     Current treatment options for hemangiomas, such as propranolol, steroids and interferon, all~     have the potential for significantly harmful side effects. The purpose of this study is to~     identify potential biomarkers that can be used to design clinical trials and accelerate the~     delivery of new treatment alternatives to children with hemangiomas.~   "
150382|NCT01598103|"~     This study will assess the safety, tolerability and efficacy of SAF312 in patients with~     overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who~     qualify for this study is insufficiently managed by antimuscarinic therapy, or patients~     poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be~     primarily determined via urodynamic measurements.~   "
150383|NCT01598090|"~     The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined~     with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis~     C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.~   "
150384|NCT01598077|"~     This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or~     recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV~     infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or~     HER2 overexpressing metastatic breast cancer or gastric cancer~   "
150385|NCT01598064|"~     Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the~     junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation;~     hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with~     portal hypertension often suffer from infections from intestinal flora, the investigators~     speculate that probiotics will be beneficial to those patients.~   "
150386|NCT01598051|"~     The objective of this study is to understand if Rivaroxaban can improve treatment~     satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real~     clinical practice.~      A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey~     will be conducted at month 0, 3, 6 using ACTS/TSQM.~      This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a~     local prospective and observational study of patients who have received Xarelto for SPAF.~   "
150387|NCT01598038|"~     The investigators hypothesize everolimus toxicities are linked to pharmacokinetic~     variabilities of everolimus. Thus, early detection of clinical or biological risk factors~     will lead to personalized dosage treatment and permit a better tolerance without altering~     efficacy.~   "
150392|NCT01597973|"~     Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are~     non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to~     treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or~     pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter~     baumannii, Klebsiella spp, Escherichia coli, Enterbactor spp. and/or Pseudomonas aeruginosa~     that demonstrates in vitro non-susceptibility defined as extensively drug-resistant~     Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both~     BSI and pneumonia at the time of study enrollment, they will be included as a subject with~     pneumonia.~      Objectives:~      Primary:~      •Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a~     carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality compared~     to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia due to~     XDR-GNB.~      Secondary:~      •Determine what treatment regimen (colistin monotherapy or colistin combined with a~     carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin~     resistance among XDR-GNB isolates during therapy.~   "
150393|NCT01597960|"~     The benefits of alternative therapeutic approaches, such as yoga, are poorly understood and~     this is particularly true of the beneficial effects on cardiovascular disease (CVD) risk. It~     is hoped that a better understanding of the value of this therapy will provide a sound~     scientific basis for including yoga in mainstream clinical practice. The investigators~     propose to study a group of 80 participants (40 Indian Asians and 40 Europeans) recruited~     from a cardiac rehabilitation programme in West London post-angioplasty as treatment for an~     acute coronary syndrome. Those who agree will undergo a series of baseline and follow-up~     measurements. 20 Indian Asians and 20 Europeans will be randomized to the yoga intervention~     plus their standard cardiac rehabilitation programme (usual care), and the remaining 20~     Indian Asians and 20 Europeans will be randomized to usual care alone. Baseline and follow-up~     measurements will be performed on all participants. In order to determine the acute effects~     of yoga the group randomised to the yoga intervention will also undergo a series of acute~     tests before and after their first yoga session.~   "
150394|NCT01597947|"~     This is a double-blind, randomized, placebo-controlled, single ascending dose study to assess~     the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study will~     take place in the US at one clinical site.~   "
150395|NCT01597934|"~     Switching to Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will result~     in faster and greater antiviral activity and lower rates of resistance emergence over~     maintaining Lamivudine(LAM)/Telbivudine(LdT)+Adefovir(ADV) combination in partial responders~     to LAM/LdT+ADV rescue therapy.~      Earlier switching to combination with the most potent regimen will be more effective to~     achieve virologic response(VR) and prevent further resistance emergence.~      All subjects will orally take assigned drugs once daily for 48 weeks. All subjects will be~     assessed at baseline and every three months thereafter. Evaluations at each visit will~     include vital signs, physical examinations, laboratory tests, HBV DNA levels and adverse~     events. At baseline and every six months thereafter, serum will be assayed for HBV serology.~     Genotypic analysis will be performed at baseline and 48 weeks.~   "
150396|NCT01597921|"~     The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of~     acute radiation dermatitis in patients with breast cancer receiving radiotherapy.~   "
150397|NCT01597908|"~     This is a two-arm, open-label, randomised, Phase III study comparing dabrafenib (GSK2118436)~     and trametinib (GSK1120212) combination therapy to vemurafenib. Subjects with histologically~     confirmed cutaneous melanoma that is either stage IIIc (unresectable) or stage IV, and BRAF~     V600E/K mutation positive will be screened for eligibility. Subjects who have had prior~     systemic anti-cancer treatment in the advanced or metastatic setting will not be eligible~     although prior systemic treatment in the adjuvant setting will be allowed. Approximately 694~     subjects will be randomised 1:1 (combination therapy:vemurafenib). The primary endpoint is~     overall survival (OS) for subjects receiving the combination therapy compared with those~     receiving vemurafenib.~   "
150398|NCT01597895|"~     The purpose of this study is to determine the effect that telaprevir and boceprevir has on~     the pharmacokinetics of maraviroc.~   "
150399|NCT01597882|"~     The UK population is ageing and the likelihood of having a long term health condition~     increases with age. Three out of every five people over 60 in the UK have a long term~     condition. Ageing and having a long term condition increases the chance of having difficulty~     being independent and carrying out day to day activities. In recent years the NHS has made a~     greater effort to prevent these difficulties in patients with long term conditions.~      One approach to help patients with long term conditions is case management, where by~     (usually) a community matron visits patients at home, looking for early warning signs of any~     worsening of their condition and arranging care and treatment. But the current way this is~     done varies across the country and hospital admissions are still rising. In order to give the~     right care at the right time, effective monitoring is needed to help the community matron~     detect and act on changes in the patient's condition.~      Loss of muscle strength in old age is linked to a poor health, but it is not known whether~     simple measures of muscle strength could be used to detect and predict declines in health in~     the short to medium term to help maintain independence and prevent an accident or hospital~     admission.~      The aim of this study is to look at whether monitoring muscle strength in case managed~     patients is practical, acceptable and useful in detecting when a patient's condition worsens.~     Each patient will be visited by the researcher in their home twice in the first week, then~     once every two weeks, for another 5 weeks, to carry out three simple measures of grip and~     respiratory strength, and complete questionnaires about their health and ability to carry out~     day to day activities. Each visit will last about 20 to 30 minutes. A small group of~     clinicians will be asked about their views of the strength measures. Database analysis will~     allow descriptive data on the patient group to be gathered and analysed.~   "
150400|NCT01597869|"~     The purpose of this study is to find all kinds of complications and it's frequency related to~     the Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) and to evaluate~     associated risk factors in patients who developed complications. The investigators performs~     EBUS-TBNA examination on all subjects that need mediastinal evaluation. All complications~     during or after the procedure will be recorded prospectively.~   "
150421|NCT01597596|"~     A study to demonstrate comparable safety, efficacy, and pharmacokinetics (PK) of~     alglucosidase alfa manufactured at the 160 litre (L) and 4000 L scales in participants who~     had been diagnosed with infantile-onset Pompe disease. Participants were treated with~     alglucosidase alfa 160 L scale product in the United States (US) and 4000 L scale product in~     the regions outside the US.~   "
150422|NCT01597583|"~     The main aim of this study is to conduct a randomized control trial to compare~     MobileMedMinder, a mobile phone based medication reminder software product, with currently~     accepted and empirically supported methods for increasing medication compliance through~     reminders and tracking.~   "
150401|NCT01597856|"~     Veterans can apply for compensation and pension (C & P) benefits for a disability related to~     military service. The application exam for these benefits provides an opportunity for~     Veterans returning from service to access VA care. The investigators will recruit Veterans~     applying for C & P to participate in this study. All enrolled participants will complete~     questionnaires around the time of their C & P exam related to substance abuse, PTSD, service~     use, and attitudes. The investigators will monitor enrolled Veterans' attendance at treatment~     over time, and examine whether C & P award, substance use, and beliefs about benefits are~     related to treatment attendance. Some enrolled participants will be assigned to one of two~     study groups: a treatment group and a no-additional-treatment group. People assigned to these~     groups will complete the same substance abuse, PTSD, service use, and attitudes~     questionnaires two additional times during the study. Participants assigned to the treatment~     group will receive information about the relationship between substance use and PTSD and will~     be referred to relevant treatment. The investigators will test whether Veterans who receive~     no-additional-treatment have different symptoms over time and attend less treatment sessions~     (mental health or substance abuse) than people assigned to treatment.~   "
150402|NCT01597843|"~     This project will design, deliver, and evaluate a peer support intervention that will help~     veterans become familiar with and register for Veterans Health Administration (VHA) My~     HealtheVet (MHV). It will lay the groundwork for 2 types of future projects. First, the~     investigators will develop materials that can be used in other settings to increase~     registration, authentication, and meaningful use of MHV. Second, it will allow us to develop~     and study interventions that use informed, peer-supported Internet use to improve health~     behaviors and outcomes among veterans.~   "
150403|NCT01597830|"~     This study evaluates the effects of specialized footwear on pain and knee loading in knee~     osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and~     knee pain.~   "
150404|NCT01597817|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by exacerbations~     and remission of intensely pruritic lesions of variable location. AD may be acute (short-term~     and severe) with predominantly redness, vesicles and oozing, or it may be chronic (long-term)~     with scaling, skin thickening, altered pigmentation and exaggerated surface markings. The~     condition affects mainly the creases of the elbows and knees, and the face and neck, although~     it can affect any part of the body. The severity of AD is variable, ranging from localized~     mild scaling to generalized involvement of the whole body. Itching is the predominant~     symptom, which can induce a vicious cycle of scratching, leading to skin damage. There is a~     tendency to lifelong dry sensitive skin. Skin of AD is often colonized by Staphylococcus~     aureus contributing to perpetuating cutaneous inflammation. AD treatment is based on skin~     hydration, identification and elimination of flare factors, and pharmacologic therapy.~     Biofunctional textiles are emerging as new and complementary tools . Chitosan is a natural~     polysaccharide with in vitro anti-microbial activity and regenerating properties. The~     investigators aim to evaluate the effect of a textile coated with chitosan in AD treatment as~     well as its impact on systemic inflammation and skin microbiome. The investigators~     hypothesize the use of biofunctional textile coated with chitosan will improve severity of AD~     , quality of life and diminish skin colonization with Staphylococcus aureus and some skin~     moulds, namely Malassezia.~   "
150405|NCT01597804|"~     This pilot clinical trial studies bathing bundle regimen in reducing gynecological surgical~     site infection in patients undergoing surgery. A bathing bundle regimen may reduce the risk~     of wound infection, extended length of hospital stay, readmission into the hospital, and the~     overall healthcare costs in patients undergoing surgery.~   "
150406|NCT01597791|"~     The investigators hypothesize that many parturients can, in fact, spontaneously micturate~     with low dose combined spinal epidural analgesic doses given for labor and that Foley~     catheterization is unnecessary in the majority of these parturients. At Prentice Women's~     Hospital, almost 9000 women annually receive neuraxial labor analgesia and 98% of those~     receive Foley catheters. By potentially reducing the necessity for Foley catheters, the~     investigators should be able to ultimately reduce the rate of bacteriuria, urinary tract~     infections and urethritis leading to unnecessary treatment with antibiotics, as well as~     reduce costs of placing unnecessary Foley catheter.The hypothesis is parturients receiving~     low dose combined spinal epidural analgesia for analgesia after induction of labor who are~     randomized to a spontaneous micturition protocol will require fewer Foley catheter placements~     and demonstrate a lower incidence of positive urine culture postpartum than those who undergo~     standard Foley catheter placement.~   "
150407|NCT01597778|"~     Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or~     lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar~     tissue type can be used for HCT. This study will compare the effectiveness of two new types~     of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow~     donated from family members with only partially matched bone marrow; and, one that uses two~     partially matched cord blood units.~   "
150408|NCT01597765|"~     The purpose of this study is to determine the efficacy of antioxidant cocktails on the~     alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.~   "
150409|NCT01597752|"~     The objective of this study is to determine the biologic activity of a Blomia tropicalis~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
150410|NCT01597739|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in patients~     with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD)~     therapy.~   "
150411|NCT01597726|"~     The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming~     to laminaria priming among women undergoing D&E at 13-20 weeks gestation in the Western Cape~     Province, South Africa~   "
150412|NCT01597713|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of~     NNC 0148-0000-0362 as tablets in healthy volunteers.~      The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362,~     placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC~     0148-0000-0362 administered orally or intravenously.~   "
150413|NCT01597700|"~     Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by~     Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of~     Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study.~     Fifty two healthy adult subjects who have satisfied the inclusion and exclusion criteria and~     given their informed consent will be entered into the study. They will be fasted and receive~     one tablet by mouth in accordance with a randomisation list and blood samples will be taken~     at specified intervals over the ensuing 3 days. Between 14 and 21 days later, subjects will~     receive the opposite tablet and the clinical process repeated. Subjects will be continuously~     monitored while in the trial clinic and at ambulatory visits with regular measurements of~     vital signs and questioned for adverse events. Drug concentrations will be analysed and these~     results compared to ascertain bioequivalence by applying statistical methods to the~     pharmacokinetic data; this information and all safety data will be formally reported.~   "
150414|NCT01597687|"~     This study aims to determine the burden of pertussis infection among adolescents and adults~     with prolonged cough in four Asian countries, namely Malaysia, Philippines, Taiwan and~     Thailand. This study also aims to assess the health economic (HE) impact of pertussis.~   "
150415|NCT01597674|"~     The objective of the study was to assess whether the tolerance to the effect of YF476 on~     gastric pH observed with repeated doses in a previous study in healthy volunteers can be~     avoided by using smaller doses of YF476.~   "
150416|NCT01597661|"~     Bupropion is a unique drug that is used both to treat depression and as an aid in smoking~     cessation. In 2008, the final report from the Bupropion pregnancy registry described 24~     congenital malformations among the 675 women exposed to bupropion in the first trimester of~     pregnancy. Of these, 9 had congenital heart disease of varying severity, including a number~     of infants with ventricular septal defects (VSDs); of note, 2 of these 9 had coarctation of~     the aorta. More recently, Alwan et al, in an analysis of data from the Centers for Disease~     Control and Prevention's case-control National Birth Defects Prevention Study, reported an~     increased risk of left outflow tract heart defects, a subgroup of cardiac malformations that~     includes coarctation of the aorta and hypoplastic left heart syndrome.~      Data from the Slone Epidemiology Center Birth Defects Study will be used to test these~     observations. The outcomes of primary interest will include those hypothesized to be~     associated with bupropion in recent studies: left outflow tract defects considered as a~     group. Coarctation of the aorta and hypoplastic left heart syndrome will also be examined~     separately. All infants with congenital heart defects are further classified into subgroups~     that are embryologically meaningful, including left outflow tract defects. In secondary~     analyses, other heart defect classes for which there are adequate numbers of cases will be~     evaluated.~   "
150417|NCT01597648|"~     This is a study in healthy adult subjects to evaluate the bioequivalence of a Combined~     Formulated Tablet compared with maraviroc and Combivir administered concurrently versus~     maraviroc + Combivir. 42 subjects will be enrolled in the study such that 40 subjects~     complete dosing and critical assessments. The total duration of a subject's participation~     will be approximately 33 to 35 days, including a screening period (Day −21 to Day −1), 2~     treatment periods (Days 1-3), at least a 7-day washout between Period 1 and Period 2, and a~     follow-up visit 7 to 14 days after the last dose of study drug in Period 2. Each dosing~     period will begin the evening prior to dosing and extend until 48 hours (Day 3) after dosing.~     Subjects will be randomly assigned to receive 1 of the following 2 treatments in Period 1~     then crossover to receive the alternate treatment in Period 2:~      In Sequence 1 (N=21) subjects will receive Treatment A followed by a 7 day washout and~     Treatment B. In Sequence 2 (N=21) subjects will receive Treatment B followed by a 7 day~     washout and Treatment A. Treatment A consists of 1 tablet of maraviroc 300 mg, lamivudine 150~     mg, and zidovudine 300 mg as a combined formulation after an overnight fast. Treatment B~     consists of 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an~     overnight fast. On Day 1 of each treatment period, subjects will receive study drug in the~     morning after an overnight fast of at least 8 hours. Study drug will be administered with 240~     mL of water. Dosing in each treatment period will be separated by a minimum washout period of~     at least 7 days between doses. All subjects will undergo safety and other assessments.~     Subjects may be discharged after all study procedures are completed on the morning of Day 3,~     with instructions to return for the next study period or the follow-up visit, as appropriate.~     The follow-up visit will occur 7 to 14 days after the last dose of study drug in Period 2.~     Pharmacokinetic blood samples will be collected during each treatment period for evaluation~     of maraviroc, lamivudine, and zidovudine before dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3,~     4, 6, 8, 12, 18, 24, 36, and 48 hours after dosing (total of 16 PK time points per treatment~     period). Protocol waivers or exemptions are not allowed, with the exception of immediate~     safety concerns. Therefore, adherence to the study protocol requirements, including those~     specified in the Time and Events Table, are essential and required for study conduct.~   "
150418|NCT01597635|"~     This is an early phase (phase IIa), randomized, multi-center study in subjects with acute~     lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is~     to investigate the safety of GSK2586881 and to determine what effects it has on people with~     Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).~      The study has two parts: Part A will be an open-label investigation in five subjects. Part B~     will be a double-blind, placebo controlled investigation and will involve approximately 60~     subjects.~   "
150419|NCT01597622|"~     This study provides subjects who complete the BEL113750 study and subjects who complete the~     open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of~     continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those~     randomized to belimumab, or the option to begin treatment with belimumab for those randomized~     to placebo, as an add-on to their standard of care SLE therapy.~   "
150420|NCT01597609|"~     Approximately 60 obese, but otherwise healthy, subjects will be assessed in this benchmark~     study to investigate the physiological changes associated with weight loss and regain. The~     aim is to estimate the changes in body composition during and after three interventions (i)~     calorie restricted diet + a marketed anti-obesity drug (sibutramine )(ii) calorie restricted~     diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise. The~     interventions will last 12 weeks, after which there is a further 12 week observation period~     during which subjects will return to their normal lifestyle and are expected to regain~     weight. Additionally, a range of biomarkers may be evaluated to determine whether there are~     correlations at early and late time points with weight and fat loss and weight and fat~     regain. The changes in body composition and other biomarkers will be used to determine~     whether mathematical models can be built that predict the weight loss and regain of~     individual subjects. In addition, the usefulness of tools that may aid the physiological~     characterisation of weight loss/regain will be assessed, in particular methods for measuring~     energy expenditure and energy intake such as ambulatory activity meter, Sussex Ingestion~     Pattern Monitor ™ (SIPM), hunger-satiety VAS, indirect calorimetry and, if available, the~     Theranos in-home graphical user interface (GUI) portal. Knowledge of the body composition~     changes resulting from these typical weight loss interventions and predictive markers of~     response would facilitate the design of future studies for novel anti-obesity agents and~     allow earlier, more informed triaging of NCEs.~   "
150423|NCT01597570|"~     It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access Closure~     System through effectiveness and safety confirmation of hemostasis (TTH; Time to hemstasis)~     and ambulation (TTA; Time to ambulation) at the puncture site of common femoral artery (CFA)~     after the procedures of Fastseal® Biosorbable Vascular Access Closure System or Perclose®~     ProGlide Suture-Mediated Closure System during 1 month observation.~   "
150424|NCT01597557|"~     The proposed study is designed to evaluate the effect of an intravenous infusion of magnesium~     sulfate in facilitating successful cardioversion of atrial fibrillation and in decreasing the~     energy threshold (in J) required for successful cardioversion of atrial fibrillation into~     sinus rhythm.~   "
150425|NCT01597544|"~     This study is divided into two parts. The first part is a prospective observational study of~     patients undergoing pelvic organ prolapse (POP) surgery. The goal is to determine patient~     preference between 3 different methods of bladder drainage in case of post-operative voiding~     dysfunction (POVD): transurethral indwelling catheterization (TIC), clean intermittent~     self-catheterization (CISC), and suprapubic tube (SPT). The second part of the study will be~     for those that choose CISC as their preferred method, whereby these patients will be~     randomized to receive CISC instruction either pre- or post-operatively to determine whether~     there is a difference in overall patient satisfaction based on timing of teaching.~      The investigators hypothesize that patients that receive informed consent pre-operatively~     will favour the use of SPT over TIC and CISC to manage potential POVD.~      Among those patients who opted for CISC in management of their post-operative voiding~     dysfunction, patients that are taught how to perform CISC pre-operatively in the clinic will~     have a higher level of satisfaction compared to those that are taught post-operatively in the~     hospital.~   "
150426|NCT01597531|"~     The purpose of this study is to determine whether addition of 1 or 2 medicines after gastric~     banding can improve remission of type 2 diabetes.~   "
150427|NCT01597518|"~     The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of~     patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at~     a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after~     injury, as compared to placebo, in change between 180 days and baseline in motor outcomes as~     measured by International Standards for Neurological Classification of Spinal Cord Injury~     Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI, presenting to the~     hospital less than 12 hours after injury. Secondary objectives are to evaluate the effects of~     riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of~     life outcomes, health utilities, mortality, and adverse events. The working hypothesis is~     that the riluzole treated subjects will experience superior motor, sensory, functional, and~     quality of life outcomes as compared to those receiving placebo, with an acceptable safety~     profile.~   "
150428|NCT01597505|"~     606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this~     study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion.~     Treatment lasted for 10 days and participants were followed up for at least 40 days and a~     maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats~     CDAD as compared to vancomycin.~   "
150429|NCT01597492|"~     The purpose of this study is to assess the impact of belimumab on immune response to~     pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).~   "
150430|NCT01597479|"~     The aim of this clinical trial is to determinate if distal ultrasound guided peripheral nerve~     blocks on target nerves (radial and median nerve blocks at the elbow), using low volume and~     low concentration of long acting local anesthetic provide better postoperative pain control~     compare with systemic analgesia alone after thumb resection arthroplasty (TRA) due to a~     prolonged selective sensitive block on the tissue trauma.~   "
150431|NCT01597466|"~     The purpose of this study is to evaluate the use of the Epidrum device to identify the~     epidural space in patients requiring thoracic epidural analgesia.~   "
150432|NCT01597453|"~     NOR-SYS is a clinical research program about young ischemic stroke patients from 15 to 60~     years. Patients, partners and the couple´s adult children who are at least 18 years old, are~     all invited to ultrasound examinations due to a standardized protocol.~      Parents of patients and partners are invited to return their answers of standardized~     questionnaires about clinical ischemic events such as stroke, angina or myocardial infarction~     or peripheral artery disease.~      Study inclusion time of patients and their families is 5 years. A biobank is build from~     samples from patients, partners and adult children. Clinical follow-ups for patients and~     partners are planned after 5, 10 and 15 years. Clinical follow-ups for adult children are~     planned after 10 and 20 years.~      Hypotheses:~      What do patients know about their parents clinical ischemic events? How much established~     pathology in arteries do we find by a standardized ultrasound protocol at the time of~     ischemic stroke at a young age? Differences concerning risk factors and ultrasound findings~     between patients and partners? Differences between children from families with several~     ischemic events among parents and grandparents vs. children from families without ischemic~     events? Biochemical markers related to ultrasound findings and artery disease.~   "
150433|NCT01597440|"~     Background: Very few drugs exist that treat hyperammonemia, specifically PA and MMA. Diet~     restrictions and alternate pathway agents are the current primary treatments, but they~     frequently fail to prohibit brain damage.~      Orthotopic liver transplantation cures the hyperammonemia of urea cycle disorders, but organ~     availability is limited and the procedure is highly invasive and requires life-long~     immunosuppression.~      A drug that could repair or stimulate a dysfunctional urea cycle such as this would have~     several advantages over current therapy. A drug called N-carbamyl-L-glutamate, Carglumic acid~     (NCG or Carbaglu)has recently been found to be virtually curative of another urea cycle~     defect called NAGS deficiency. In this disorder, treatment with NCG alone normalizes~     ureagenesis, blood ammonia and glutamine levels, allows normal protein tolerance and restores~     health. Knowledge from this study is being applied to acquired hyperammonemia, specifically~     in patients with propionic PA and MMA, to try and improve neurodevelopmental outcomes by~     improving the hyperammonemia.~      Aims: The overall objective of this project is to determine whether treatment of acute~     hyperammonemia with Carglumic acid in propionic acidemia (PA), methylmalonic acidemia (MMA)~     changes the long-term outcome of disease and to determine if it is effective in restoring~     urine ammonia levels to normal levels.~   "
150435|NCT01597414|"~     Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast~     cancer. Chemotherapy however is associated with significant side-effects and can impact on~     Quality of Life and functionality in older patients.~      The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to~     delay or even avoid the use of classical chemotherapy because of competing risks of death in~     this frail/elderly patient group.~   "
150436|NCT01597401|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and~     pharmacodynamic effects of Aes-103 (active ingredient 5-hydroxymethyl-2-furfural [5-HMF])~     compared with placebo in subjects with stable sickle cell disease (SCD). Safety will be~     measured by monitoring adverse events (AEs), electrocardiograms (ECGs), vital signs, and~     laboratory values. Pharmacokinetics of Aes-103 will be measured over time in plasma, red~     blood cell hemolysate and binding of Aes-103 to hemoglobin. Pharmacodynamic effects will be~     assessed by measuring partial pressure of oxygen at which 50% of hemoglobin is saturated with~     oxygen (p50) while breathing normal air, blood oxygen levels (SpO2), ex-vivo antisickling~     effects in a hypoxic environment, and by imaging related changes in tissue blood flow and~     oxygen levels.~   "
150437|NCT01597388|"~     The purpose of this study is to assess safety and tolerability of AZD2014 when given in~     combination with Fulvestrant.~   "
150438|NCT01597375|"~     The investigators are doing this research study to find out if giving a drug called~     prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people~     with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every~     day can work as a treatment for people with AERD. People with AERD have symptoms of asthma,~     severe runny nose, polyps in the nose, and develop allergic reactions if they take~     medications like aspirin.~      People with AERD can be desensitized to aspirin in order to be able to safely use it daily,~     but the investigators do not know if prasugrel may prevent reactions to aspirin and provide a~     safer way for people with AERD to tolerate aspirin.~      The investigators also want to understand what is different about the cells and urine from~     subjects who have AERD, in comparison to subjects who have asthma but do not have AERD and~     subjects who have allergic rhinitis but do not have asthma. Lastly, the investigators want to~     understand how aspirin acts differently in subjects who have AERD, in comparison to subjects~     who have asthma but do not have AERD.~   "
150439|NCT01597362|"~     The study compares the Veress needle technique, the Direct trocar insertion and the Open~     technique with each other, in terms of minor complications, in elective laparoscopic~     procedures for benign pathologies.~   "
150440|NCT01597349|"~     The purpose of this research study is to learn how effective and safe FP01 lozenges are when~     given to subjects with a cough due to an upper respiratory tract infection. The study will~     include subjects who have an upper respiratory tract infection, with a cough of less than six~     weeks duration.~   "
150441|NCT01597336|"~     The objective of this study is to evaluate the utility of fibrinolysis when draining an~     abdominal abscess as defined by length of stay after drainage.~   "
150442|NCT01597323|"~     Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light~     based device for the treatment of facial wrinkles.~   "
150443|NCT01597310|"~     This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the~     CYP2C9 probe substrate warfarin in healthy volunteers.~   "
150444|NCT01597297|"~     The objectives of this study in Multiple Sclerosis (MS) participants treated with~     prolonged-released fampridine (BIIB041) 10 mg twice daily compared with participants treated~     with placebo are to assess the effect over 24 weeks on the following parameters to explore~     endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static~     balance, subjective impression of well-being, and participants' global impression of change~     in walking . Another purpose of this study is to evaluate the safety and tolerability of~     prolonged-release fampridine.~   "
150445|NCT01597284|"~     The investigators propose to evaluate the compliance of oral cancer therapies, particularly~     the possible link between this observance and cognitive function of patients at initiation of~     treatment. To our knowledge, this study will be among the first conducted on the issue in~     France and is an innovative approach in the management of cancer patients. The inclusion of~     cognitive dysfunction is part of a comprehensive approach to improving the quality of life~     and fully meets the objectives of both plans cancer, including those of the axis Living~     during and after cancer highlighted in the Cancer Plan~   "
150446|NCT01597258|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
150447|NCT01597245|"~     This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to~     etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.~   "
150448|NCT01597232|"~     Guidelines for blood transfusion have been issued for years. According to these guidelines,~     red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than~     6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the~     guidelines, the determination of whether RBCs should be administered when the hemoglobin~     level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or~     surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and~     10g/dL is necessary and important in clinical practice.~      Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen~     consumption, the investigators hypothesize that index of transfusion trigger for patients~     with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including~     infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired~     oxygen, core temperature, and angina. To verify this hypothesis, the investigators present~     West China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according~     to the patient's history and monitoring parameters, and the investigators design a randomized~     controlled clinical trial to test this score.~   "
150463|NCT01597037|"~     The purpose of this study is to evaluate how changing different conditions of the~     speech-language treatment (such as cues, feedback, complexity and practice schedule) affects~     the language outcome of study subjects with aphasia (i.e., difficulty with the comprehension~     and expression of spoken and written language) following a stroke.~   "
150449|NCT01597219|"~     This trial investigates stem cell transplants from partially mismatched donors in patients~     with blood and bone marrow cancers. The trial will test two kinds of transplants - a full~     intensity transplant using a high dose of radiotherapy and chemotherapy, and a reduced~     intensity transplant with lower doses of chemotherapy and radiotherapy. Patients will be~     entered for the treatment pathway that is most appropriate for their level of health and~     fitness~   "
150450|NCT01597206|"~     Dental services for large sectors of the population of the Western Cape (WC) Province of~     South Africa (SA) has been, and continues to be, limited to low-cost treatment options and~     emergency services, such as extractions at public health clinics. Replacement of missing~     teeth for the disadvantaged majority of the population is provided almost exclusively at the~     dental teaching institutions. Loss of teeth in the WC Province is, as elsewhere, the result~     of disease and the lack of restorative care and then having these replaced by a removable~     partial denture, if the patient can afford it Null Hypothesis: The daily functional needs and~     quality of life of partially dentate adult patients with a reduced posterior dental arch and~     /or a Shortened Dental Arch (SDA) will not be satisfied nor improved by replacing the~     posterior teeth with a removable prosthesis.~   "
150451|NCT01597193|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in~     patients with incurable breast cancer.~   "
150452|NCT01597180|"~     The purpose of this trial is to learn about potential interactions between raltegravir and a~     birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on~     steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40,~     inclusive, who report regular monthly menses.~      The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE)~     and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular~     medical care. Women will be enrolled in the study for approximately 8 months.~   "
150453|NCT01597167|"~     The proposed study is a 1-week, randomized, double-blind, placebo-controlled, trial to~     evaluate the efficacy of an IV infusion of magnesium sulfate on symptoms of treatment~     resistant mild and moderate depression in 20 males and females (21-70 years of age).~     Participants will be assessed at screening/baseline, day 1, day 2, day 7, and day 8. Each~     subject will be randomized in a double-blind fashion to receive either IV infusion of~     magnesium sulfate or 5% dextrose followed by a washout period of 5 days then crossover to~     receive either IV infusion of 5% dextrose or magnesium sulfate.~   "
150454|NCT01597154|"~     Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased~     physical activity and dietary changes) for the management of glycemia and cardiometabolic~     risk factors in children and adolescents with type 2 diabetes (T2DM).~      Our hypothesis is that education regarding healthy lifestyle changes will significantly~     reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary~     hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions~     in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL~     cholesterol, serum triglycerides and apolipoprotein B.~   "
150455|NCT01597141|"~     The primary aim of this application is to conduct a randomized, controlled clinical trial of~     a specialized mental health service delivery system specifically developed for prodromal~     psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT).~     The goal of the treatment is prevention of psychosis and disability. This study will assess~     experimentally the clinical effectiveness of this new type of mental health service. Other~     domains of outcome include cognitive dysfunction and functional disability.~   "
150456|NCT01597128|"~     This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE®~     Reconstructive Tissue Matrixin the repair of hernias.~   "
150457|NCT01597115|"~     The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular~     access surgery with native vein for hemodialysis can increase the maturation rate of~     arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1~     randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2~     and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks~     after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after~     surgery by duplex in all patients.~   "
150458|NCT01597102|"~     The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy.~     Patients with the indication to liver transplantation mostly have mild to severe hepatic~     encephalopathy. Transplantation should recover the encephalopathy. The aim of the study is to~     investigate the AR during liver transplantation, with the questions if the AR is impaired at~     the beginning of surgery and if there are changes in AR. For follow up the AR will be~     measured at the first days after transplantation at the ICU.~   "
150459|NCT01597089|"~     Background:~      - Bronchoalveolar lavage (BAL) is a procedure where a tube is passed through the mouth or~     nose into the lungs. Fluid is squirted through the tube into a part of the lung and then~     collected for examination. It is used to detect respiratory viruses. BAL is a relatively~     invasive procedure, and researchers want to test the accuracy of other procedures that do not~     involve collecting fluid from the lungs. The nasopharynx is the area of the upper throat that~     lies behind the nose. Researchers want to see if a swab taken from this area is as accurate~     as a BAL sample.~      Objectives:~      - To see if a nasopharynx swab can be used to detect respiratory viruses as well as BAL~     samples.~      Eligibility:~      - Individuals at least 12 years of age who will have a bronchoscopy to collect a BAL sample~     to test for respiratory viruses.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have a BAL sample collected.~        -  Participants will then have a nasopharynx swab. The swab will be inserted into the nose,~          left in place for up to 10 seconds, and then removed~   "
150460|NCT01597076|"~     The objectives of this clinical trial are to evaluate the effectiveness of an iridoid~     enriched beverage containing noni and cornelian juices and olive leaf extract on advanced~     glycation end product levels.~   "
150461|NCT01597063|"~     Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled.~     Study blood will be collected in the first or second trimester at a scheduled prenatal~     screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will~     be followed until delivery and the birth outcome recorded.~   "
150465|NCT01597011|"~     In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is~     either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue~     (Tisseel/Tissucol) or left unfixated.~      The investigators believe, and previous studies indicate, that the use of fibrin glue greatly~     reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in~     men or recurrence of the hernia)when compared with the use of tacks or staples.~      The aim of this study is to compare the recurrence rates and amount of postoperative~     complications in patients who have had inguinal hernia repair with fibrin glue and in~     patients who have had inguinal hernia repair with tacks, staples or sutures.~   "
150466|NCT01596998|"~     The aim of this study is to determine the effect of the addition of vasoconstrictor in the~     plasma concentrations achieved and the extent of the transversus abdominis plane block in~     healthy male volunteers.~   "
150467|NCT01596985|"~     Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation~     using the PlasmaJet system versus cystectomy, using postoperative examination by 3D~     ultrasound.~      Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two~     University tertiary referral centers.~      Patients: Fifty women with no previous history of ovarian surgery managed for unilateral~     ovarian endometrioma > 30 mm in diameter.~      Interventions: Endometrioma ablation by plasma energy using the PlasmaJet system and ovarian~     tissue sparing cystectomy.~      Main Outcome Measures: 3D ultrasound assessment of postoperative reduction in ovarian volume~     and antral follicle count (AFC) .~   "
150468|NCT01596972|"~     The primary aim of this study is to determine if a self-administered semi-quantitative urine~     pregnancy test and telephone pregnancy symptom questionnaire can reduce the percentage of~     women with a complete uterine evacuation who require a clinic or lab visit to confirm~     completion.~      The investigators hypothesize that women with complete uterine evacuation will be less likely~     to require a follow-up clinic or lab visit by using a standardized pregnancy questionnaire~     and home SQ-UPT, than by using serum hCG as the objective measure of completion.~   "
150469|NCT01596959|"~     This study will be a single blind prospective randomised control trial in patients undergoing~     ablation for the treatment of typical atrial flutter, with the aim of investigating the~     benefit of a new impedance-based computer software application which measures tissue contact~     between the ablation catheter and the inside of the heart.~      The investigators hope to demonstrate that the use of this tissue contact information reduces~     ablation time, Xray time, and procedure time required to complete the procedure successfully.~     Study participants will be randomly assigned to undergo their procedure with or without this~     contact data displayed for the doctor performing the ablation to see. The acute procedural~     endpoint of ablation is successful conduction block across the cavotricuspid isthmus of the~     right atrium. If the outcome of this study is positive, it will have a significant beneficial~     impact on this procedure, reducing procedure length, patient discomfort, and potentially~     reducing risk for the patient, recurrent arrythmia symptoms, and the need for repeat~     procedures later on.~   "
150470|NCT01596946|"~     Though partner notification is mandatory to perform of Chlamydia trachomatis infected~     individuals in Sweden, there was a 10-15% annually increase of reported cases between 1997~     and 2007 indicating that partner notification may not be effective in preventing~     transmission. The investigators wanted to determine whether there was any difference in time~     between home-sampling and clinical testing as a tool of partner notification measured from~     eliciting of partners to date of testing.~   "
150471|NCT01596933|"~     Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from~     an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by~     cachexia. Head and neck (H&N) cancer patients are nutritionally vulnerable since tumour~     localisation can interfere with food intake, since alcohol and tobacco abuse - two~     etiological risk factors of H&N cancer - are associated with nutritional deficits, and since~     the intensive treatment can lead to progressive weight loss. Recently, omega-3 fatty acids~     have gained interest for their beneficial effects in several diseases. Moreover, nutritional~     supplementation enriched with omega-3 FA could potentially maintain body weight in cancer~     patients undergoing intensive treatment.~      Aims In this study, the investigators want to evaluate the use of omega-3 FA supplementation~     as nutritional and the investigators would like to identify potential risk factors,~     biomarkers and objective measurement tools which can predict therapy-induced cachexia.~   "
150472|NCT01596920|"~     The primary objective of the present study is to further establish in a randomized controlled~     trial, the safety and efficacy of weekly Grafix® administration versus control in patients~     with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the~     index wound, defined as 100% re-epithelialization as determined by the Investigator.~      Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue~     Based Product (HCT/P) under Title 21 CFR Part 1271.~   "
150473|NCT01596907|"~     Purpose is to determine the effect of ephedrine and caffeine, on metabolic rate and weight~     loss after bariatric surgery. Approximately 40% of patients struggle with their weight loss~     rate, or metabolic rate, after bariatric surgery, and at least 30% previously had or develop~     a low metabolic rate after surgery. Metabolic rate is the speed at which calories are burned.~     The fewer the calories eaten and the more calories burned, the more rapidly weight is lost.~     It is possible that despite a very low calorie intake following bariatric surgery metabolic~     rate will decrease so much so that weight does not decrease even if intake is reduced to 1000~     calories per day. Ephedrine is a medicine used commonly to treat asthma, difficulty~     breathing, and wheezing. However, 40 years ago it was reported in scientific studies that~     ephedrine increases weight loss in patients on low calorie diets by increase the amount of~     calories that are burned. Combining caffeine with ephedrine makes ephedrine work more~     efficiently (more weight loss over time). Many studies show the effect of ephedrine on weight~     loss that began in 1974 with patients on food diets. Ephedrine used in various strengths and~     with a number of different combinations has shown to be effective and safe, especially when~     directed by a physician. There is only one study where ephedrine has been used in patients~     after bariatric surgery. In that study, both the patient and medical staff knew they were~     taking ephedrine (i.e., they were not blinded). The patients who were not losing weight or~     had measured low metabolic rates were treated with ephedrine. The patients taking ephedrine~     lost more weight after surgery than those not taking ephedrine. While this is a significant~     finding, the study was not designed to be the best test of the effects of ephedrine. The best~     test is where neither the patients nor the medical staff know if the patient is taking the~     active drug (double blind). All patients enrolled into the Research Study will receive~     capsules that contain either ephedrine and caffeine (the active drug) or identical capsules~     with no active ingredient (called a placebo). Neither group of patients will know which set~     of capsules they receive. The expected duration of treatment in the Study is 7 months from~     the day of surgery. This is a single site study. All patients will have their gastric bypass~     performed through Oregon Weight Loss Surgery at Legacy Good Samaritan Hospital. The~     investigators expect to study 200 patients with 100 receiving the study drugs (ephedrine and~     caffeine in a capsule) and 100 receiving placebo (inactive ingredients in an identical~     capsule) over approximately 6 months.~   "
150474|NCT01596894|"~     The purpose of this study is to evaluate effectiveness of 2 months antibiotic course of~     Azithromycin combined with Metronidazole compared with 2 months antibiotic course of~     Metronidazole alone.~   "
150475|NCT01596881|"~     Recent studies have shown that people with multiple sclerosis (MS) who also have diseases~     related to vascular health such as high cholesterol, high blood pressure, diabetes,~     cardiovascular disease, and others, may end up more disabled than people with MS who don't~     have those diseases. This has led to a growing interest in the role of vascular diseases in~     MS since they may provide another avenue of MS treatment. Some also think that vascular~     disease may even be a cause of MS. The back of the eye, the retina, is well-suited to~     studying vascular diseases as blood vessels can be seen even on routine examination of the~     eye by eye doctors. These specialists are used to seeing changes in retinal blood vessels due~     to diseases known to affect the eyes such as glaucoma and diabetes. Sophisticated techniques~     for examining the retina allow for not only visualization of blood vessels, but the rate of~     blood flow through the blood vessels as well. These blood flow changes are thought to come~     before changes in what the blood vessels look like, and so may be able to detect problems~     even earlier than routine examination of the retina by eye doctors. Retinal blood flow has~     never been carefully studied in MS. Given that MS affects the retina due to the late effects~     of inflammation of the optic nerve, or optic neuritis, the investigators expect to see~     altered blood flow in the retinal blood vessels of people with MS compared to healthy control~     subjects. If so, the investigators can then use retinal blood flow as a way to measure~     therapies that target vascular diseases in the MS population and determine if those therapies~     can alter the course of disease.~   "
150476|NCT01596868|"~     The present study is a randomized, control, phase II study of locally advanced nasopharyngeal~     carcinoma (NPC) in Northwest China treated with Gemcitabine plus cisplatin regimen (GP) or~     Docetaxel plus cisplatin regimen (TP) induction chemotherapy followed by concurrent~     chemoradiotherapy. The population consists of stage III-IVb nasopharyngeal carcinoma (NPC).~     The effectiveness, side effects and quality of life will be evaluated according to Standard~     WHO response criteria, NCI-CTC AE V3.0 and EORTC QLQ-C30 and H&N35 questionnaire.~   "
150477|NCT01596855|"~     The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining~     and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on~     maintenance hemodialysis and receiving epoetin alfa.~   "
150478|NCT01596842|"~     Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1,~     25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high~     dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D~     concentrations were significantly increased after 3 months of omega-3 FA supplementation~     compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients.~     In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D~     supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to~     25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or~     deficient 25-hydroxyvitamin D levels.~   "
150479|NCT01596829|"~     Antibiotic treatment disturbs the balance of the intestinal microbiota and predisposes to~     antibiotic associated diarrhea. Previous studies have shown that the risk of developing~     diarrhea during a course of antibiotics may be reduced by simultaneous consumption of~     probiotics. The aim of the present study is to assess the effect of a probiotic formula~     containing four strains on reducing the risk of antibiotic associated diarrhea.~   "
150480|NCT01596816|"~     hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy~     (prostate + seminal vesicles).~   "
150481|NCT01596803|"~     On the basis of published data and the investigators' results indicating that oxidative~     stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD,~     the investigators propose a study to test whether or not an antioxidant supplementation has a~     therapeutic interest for patients with FSHD. Their results have important implications for~     the successful implementation of rational antioxidant therapy in FSHD in which cell loss~     could be linked to oxidative stress.~   "
150482|NCT01596790|"~     Treatment of metastatic colorectal cancer needs chemotherapy in most of the cases. During~     these last years, many new chemotherapies and targeted therapies have been developed~     improving significantly the overall survival of patients. However, the choice of the~     therapeutic sequences becomes difficult due to the lack of validated predictive biomarkers of~     their efficiency. Indeed, only the mutation of the k-ras oncogene is a predictive factor of~     non-efficacy of the anti-EGFR antibodies. It is thus crucial to identify new biomarkers to~     propose the best personalized 1rst line therapeutic sequence. One idea would be to enumerate~     and characterize the circulating tumor cells (CTC) which, as it has been described in a~     recent study realized by Cohen et al. in patients with metastatic colorectal cancer, would~     give us an early evaluation of the therapeutic efficiency. In this context, the investigators~     have developed an innovative technology, the EPISPOT assay (patent of the University Medical~     Center of Montpellier), that allows the detection & characterization of viable CTC in the~     peripheral blood. The EPISPOT technology has been already evaluated in the breast and~     prostate cancer. Thus, the investigators would like to perform a prospective study on a~     cohort of patients with metastatic colorectal cancer to confirm, with this technology, the~     predictive value of CTC count for the efficacy of the treatment.~   "
150483|NCT01596777|"~     The purpose of this study is to describe the effects of methylnaltrexone in preventing~     loperamide-induced delay of the oro-cecal and whole-gut transit time and measure~     pharmacokinetics of methylnaltrexone after subcutaneous and oral administration of immediate~     release and extended release capsules.~   "
150484|NCT01596764|"~     The purpose of this study is to describe the effects of repeated-dose methylnaltrexone in~     preventing loperamide-induced delay of whole-gut, oro-cecal and colon transit time and to~     measure pharmacokinetics of methylnaltrexone and naloxone-3-glucuronide after oral~     administration of methylnaltrexone and naloxone.~   "
150485|NCT01596751|"~     The purpose of the Phase 1b portion of the study is to determine the best dose of PLX3397~     when given in combination with standard dose eribulin (Halaven™). The purpose of the Phase 2~     portion of the study is to find out what effects, good and/or bad, these drugs have on~     patients and their metastatic breast cancer.~   "
150517|NCT01596335|"~     The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with~     a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with~     Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The~     pharmacokinetics of TA-650 is also examined.~   "
150486|NCT01596738|"~     The use of platelet aggregation inhibitors, including aspirin and clopidogrel, has become a~     standard management strategy for patients with acute coronary syndrome. On this background,~     an increasing percentage of patients presenting for surgical coronary revascularization is~     the subject to irreversible platelet inhibition.~      Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for~     aprotinin when the latter has been suspended in 2007.The release of plasmin during CPB~     activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition~     of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis~     after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and~     inhibits fibrinolysis.~      Many studies and meta-analyses have shown a reduction in postoperative bleeding and~     transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery.~     Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few~     studies specify the time between the last clopidogrel ingestion and surgery.Several studies~     were keen on the blood loss and allogeneic transfusion in patients who received their last~     clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the~     secession of aprotinin and the increasing proportion of patients with persistence on~     clopidogrel until their surgery, evolutional work is expected, especially in the eastern~     population.~      The purpose of this study is to assess the effect of tranexamic acid in patients with~     clopidogrel and asprin ingestion less than 7 days prior to surgery. The working hypothesis is~     that tranexamic acid would reduce bleeding and transfusion requirements in this specific~     population of patients.~   "
150487|NCT01596725|"~     The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian~     flu vaccine with and without adjuvant 2 in healthy, young adults. The study is divided down~     into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test~     article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment~     following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts~     of the study.~   "
150488|NCT01596712|"~     This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and~     immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the~     eligibility of Japanese patients in subsequent clinical studies.~   "
150489|NCT01596699|"~     The purpose of this study is to find out what effects, good and/or bad, the addition of~     clofarabine, a new chemotherapy agent, to a standard busulfan and fludarabine conditioning~     treatment has. The study will also look at what causes some people to have high drug levels~     of these medications in their body compared to other people that may have low drug levels~     even if they all receive the same dose of medication.~   "
150490|NCT01596686|"~     The investigators intend to study the impact of two different preparation regimens for~     colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient~     tolerability.~   "
150491|NCT01596673|"~     The purpose of this study is to assess the relative abuse potential of the hydrocodone~     bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.~   "
150492|NCT01596660|"~     The ambulatory management after laparoscopic hysterectomy is a reality in our service, where~     90% of hysterectomies are laparoscopically done and 80% of these are managed on an ambulatory~     basis with shorter hospital stay ;less than 12 hours. (OALOS 9.41 + / - (1.79) range from 5~     to 12 hours and POLE 5.38 + / - (1.8) range from 2 to 9 hours)~      So far the immediate analgesic management has been made systemically, and the satisfaction~     reported by patients was high, even though some patients require longer stay in recovery and~     need higher doses of analgesics before their discharge criteria, allowing an optimal~     ambulatory management.~      There are several treatment options that theoretically could be used but the results have~     been variable and have failed to demonstrate the expected benefit.~      The Transversus Abdominis Plane Block consists in the deposition of local anesthetic in the~     plane between the internal oblique and transverse abdominal, looking to infiltrate the spinal~     nerves at this level, so the innervation to the skin, muscles and the parietal peritoneum~     will be interrupted. The TAP Block was first described in 2001 , based on anatomy marks~     techniques of the peripheral nerves and was developed and evaluated later by McDonnell et al.~   "
150493|NCT01596647|"~     This is a multi-center, open-label, phase I study to assess the effects of dovitinib (TKI258)~     on the pharmacokinetics of a cocktail of caffeine, diclofenac, omeprazole and midazolam in~     patients with advanced solid tumors, excluding breast cancer. The aim of this study is to~     evaluate the potential effect of dovitinib (TKI258) on the metabolism of the probe drugs~     caffeine, diclofenac, omeprazole and midazolam, which are metabolized by CYP1A2, CYP2C9,~     CYP2C19 and CYP3A4 respectively (Cytochrome P450 isoenzyme), comparing the single-dose~     pharmacokinetics (AUCtlast, AUCinf and Cmax parameters) of each of the individual probe drug~     co-administered with and without multiple dose of dovitinib (TKI258) 500 mg under a 5 days on~     / 2 days off dose schedule. The study foresees two treatment phases: DDI (drug-drug~     interaction) followed by post-DDI. During the DDI phase patients receive treatment with the~     probe drug cocktail and dovitinib (TKI258). During the post-DDI phase patients may continue~     to receive treatment with dovitinib (TKI258) until disease progression (assessed by RECIST~     1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other~     reason.~   "
150494|NCT01596634|"~     The purpose of this research study is to determine if using a lactoferrin supplement will~     improve taste perception. Lactoferrin is a type of protein that is naturally produced in the~     body and is commonly found in saliva.~   "
150495|NCT01596621|"~     The primary objective of the study is to determine the overall response rate (ORR), which~     includes complete response (CR) and partial response (PR), to bendamustine treatment in~     patients with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a~     rituximab-containing therapy.~   "
150518|NCT01596322|"~     Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.~   "
150541|NCT01596023|"~     The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA~     clearance for use in patients with respiratory difficulty. The investigators believe that the~     Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added~     tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe~     chronic obstructive lung disease (COPD) to assess their work of breathing while using the~     NIOV system as measured by esophageal and stomach pressures.~   "
150496|NCT01596608|"~     Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression, and~     is also useful in treatment-refractory cases of schizophrenia and obsessive compulsive~     disorder (OCD). However, its use is limited by significant adverse effects on memory and~     cognition. In addition, ECT cannot be precisely targeted, since it relies on unpredictable~     pathways of electrical conduction through the brain. Magnetic seizure therapy (MST) is~     currently under investigation as a targetable, cognition-sparing alternative to ECT. MST uses~     magnetic fields rather than electrical stimuli for seizure induction, dramatically reducing~     the passage of induced current through undesired brain regions. 10 years of experimental~     studies have established the safety of MST in animal and human subjects. This pilot study~     will investigate whether MST has similar efficacy to ECT, with fewer cognitive side effects,~     in patients with severe depression, schizophrenia, and OCD.~   "
150497|NCT01596595|"~     Post-approval studies of implanted leads provide an opportunity to observe and assess patient~     outcomes and technology performance in a real-world setting. The goal of the study is to~     evaluate, document and report on the appropriate clinical performance, long-term reliability~     and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the~     pulse generator 4-SITE Header.~   "
150498|NCT01596582|"~     Shared decision-making (SDM) has been advocated as a strategy for increasing colorectal~     cancer (CRC) screening rates. Our studies to date suggest that while the use of a novel~     computer-based decision aid facilitates several components of SDM from both the patient and~     provider perspective, there is a reluctance among providers to acquiesce to patient~     preferences for a particular screening strategy when its differs from their own. The overall~     objective of this study is to assess whether risk stratification for advanced colorectal~     neoplasia influences clinical decision-making related to screening test selection and~     adherence within a SDM framework. Eligible subjects will be randomized to either an~     experimental arm, in which they will be asked to complete a 6-item risk assessment~     questionnaire known as the Advanced Colorectal Neoplasia Index [ACNI] after reviewing a~     web-based decision aid, or a control arm, in which they will only review the decision aid.~     Both interventions will take place just before a prearranged office visit with their~     provider. The primary outcome will be screening test ordered; secondary outcomes will include~     test completion rates, concordance between test preference and test ordered,, patient~     satisfaction with decision-making process, screening intentions, 6-month test completion~     rates and provider satisfaction. Outcomes will be evaluated using computerized tracking~     systems or validated instruments.~   "
150499|NCT01596569|"~     This study investigates the efficacy of a novel neurorehabilitation program combining~     noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive~     therapy, on cognitive function and quality of life in individuals with blast-induced~     traumatic brain injury (bTBI).~   "
150500|NCT01596556|"~     To the best of our knowledge, a possible relation between smoking and heat injuries or heat~     intolerance was never scientifically examined, although such a relation is logical according~     to the observations that smoking has a thermogenic effect, decreases physical fitness and~     affects the body's heat dissipation.16 healthy young male volunteers will participate in the~     study, 8 smokers and 8 non-smokers. They will arrive to our lab four or six times. They will~     perform VO2 test and heat tolerance test (HTT) in different conditions.~   "
150501|NCT01596543|"~     The purpose of the present study is to evaluate the effect of partial and complete sleep~     deprivation on exercise heat tolerance. Twelve healthy young male volunteers will participate~     in the study. They will arrive to our lab four times, in each visit the will undergo VO2 test~     and Heat Tolerance Test (HTT) after sleeping different amount of hours.~   "
150502|NCT01596530|"~     To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours~   "
150503|NCT01596517|"~     The purpose of this study is to investigate the efficacy and effectiveness of peginterferon~     alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.~   "
150504|NCT01596504|"~     Primary Objective:~      - To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily~     (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma~     glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after~     a standardized breakfast at the end of a 8-week treatment period in participants with type 2~     diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin).~      Secondary Objectives:~        -  To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8~          mg QD after an 8-week treatment period in participants with T2DM not adequately~          controlled with insulin glargine (± metformin) on:~             -  Post-prandial C-peptide, glucagon and appetite perceptions after a standardized~               breakfast,~             -  Appetite perceptions after standardized dinner,~             -  Gastric emptying after a standardized labelled test meal,~             -  Fasting plasma glucose, 24-hour plasma glucose profile,~             -  Glycosylated hemoglobin (HbA1c),~             -  Insulin glargine dose,~             -  7-point self monitored plasma glucose (SMPG),~             -  Body weight and waist circumference,~             -  24-hour heart rate and blood pressure,~        -  To assess lixisenatide and liraglutide safety and tolerability as add on treatment to~          insulin glargine (± metformin).~   "
150505|NCT01596491|"~     The treatment of neuropathic pain ist still a challenge. A new promising therapy is the use~     of capsaicin on skin.~      The investigators first experiences with capsaicin in patients with peripheral nerve injury~     showed changes in the sensibility, which achieved its maximal extent after four weeks and was~     regressive, but not completely abolished 1,5 months after application.~      In this study the investigators hope to specify, how long and in which way exactly this~     changes in sensibility appear.~   "
150538|NCT01596062|"~     The aims of this study are to extensively study the levels of CD25-Receptors saturation and~     expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to~     demonstrate that saturation and expression vary according to the dose of Simulect® given),~     and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the~     data with Neoral®.~      It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks~     post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in~     combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin~     inhibitor free immunosuppressant therapy.~   "
150506|NCT01596478|"~     The efficacy of psychosocial treatments for PG, including cognitive-behaviour therapy (CBT)~     and motivational interviewing (MI) approaches, has been supported in a handful of clinical~     trials. Indeed, there is more evidence supporting these two approaches than for any other~     psychosocial treatment for problem gambling. However, while efficacy studies have been~     conducted, few studies have examined the effectiveness of behavioural treatment in~     community-based gambling treatment settings. That is to say, the investigators have a good~     idea of what works in a laboratory setting (i.e., university research settings), but the~     investigators have no research assessing the transfer of evidence-based treatments for~     problem gambling to community care. Efficacy studies provide substantially less information~     about the actual utility of treatments than do effectiveness trials because the way in which~     treatment is actually provided in the field (with flexibility in terms of time-frame and~     technique and the tendency to address co-occurring problems) is different from the much more~     single-focused (on gambling) way it is conducted in laboratory settings. The proposed study~     is designed to address this significant gap in the research literature. The investigators~     propose to conduct a treatment effectiveness trial examining a combined cognitive~     motivational behavior therapy (CMBT) delivered by community-based problem gambling treatment~     providers, compared with treatment as usual (TAU).~   "
150507|NCT01596465|"~     Our objective was to test two educational interventions for teaching cardiac auscultation:~     self-directed learning using portable audio files versus a single, massed multimedia lecture~     intervention similar to current best practice, to determine which would most effectively~     increase recognition of common cardiac sounds by physicians. The investigators hypothesized~     that doctors learning on their own time could better improve their skills.~   "
150508|NCT01596452|"~     Modern anti-cancer treatments are focused on development of molecular based therapies i.e.~     specific treatments targeted against underlying biological processes. There is still much to~     learn about the biology of cancer, especially in tumours such as colorectal and lung cancer~     where it is likely multiple heterogenous signaling pathways are responsible for progression~     of disease. This project aims to evaluate circulating tumour cells (CTCs) as a surrogate~     biomarker for tumour characteristics and to determine how they may used to identify new~     targets for therapeutic agents. Their use could be applied to diagnosis of cancer, prediction~     of response to therapies and prognosis, ultimately across a broad range of tumour types.~     Currently the only way to investigate molecular features of a cancer is through procurement~     of an invasive tumour biopsy that is often difficult to obtain, often results in insufficient~     material and is unpleasant for the patient. A blood-based test would provide a much more~     practical and patient friendly alternative. The enumeration and molecular characterisation of~     CTCs has the novel potential of being a virtual biopsy of the tumour and offers the~     opportunity for immediate therapeutic decisions (eg. if the tumour develops a therapy~     resistant genotype while on treatment). CTCs have been known to circulate in bloodstream of~     cancer patients for many years and are known to lead to cancer metastases. They have been~     very difficult to detect, up until recently, due to the complexity of the metastatic process~     and detecting relatively small numbers of CTCs amongst billions of red and white blood cells.~     However, technology has moved on dramatically in the last few years. The FDA approved~     CellSearch platform (Veridex, NJ) can isolate and enumerate CTCs based on the immunomagnetic~     capture of EpCAM (epithelial cell adhesion molecule) positive cells. Several studies have~     recently demonstrated the value of CTC enumeration in reflecting prognosis and predicting~     early response to systemic chemotherapy. For example, in a study comprising 456 patients with~     metastatic colorectal cancer starting a new line of therapy, patients with =3 CTCs per 7.5 ml~     blood at baseline had shorter progression free survival (PFS) and overall survival (OS)~     compared to those patients with < 3CTCs at baseline (PFS 4.5 versus 7.9 months P=0.0001; OS~     8.5 versus 19.1 months P=0.0000 respectively). Overall survival for patients converting to or~     maintaining CTCs =3 within a few weeks of commencing systemic therapy remained worse than for~     those patients maintaining CTC counts < 3 per 7.5ml blood. Similar results have been reported~     in patients with breast and hormone refractory prostate cancer (HRPC). These studies have led~     to FDA approval of the CellSearch system as an adjunct to monitoring patients with these 3~     tumour types. The CellSearch platform, however, does not allow for the downstream DNA~     analysis of captured cells and the ferroparticle-coated CTCs are non-viable. Furthermore,~     this platform is a multi-machine, multi-kit system that is laborious (typical 3-7 days~     turnover time), expensive (USD 650), and subject to operator variance. In this protocol, the~     investigators propose for the first time, an automated, fully quantitative system for~     isolation and enrichment of CTCs. The key differentiating feature of our novel CMOS system is~     the electrochemical identification and counting of tumour cells using a high density~     electrode array with associated electronics for addressing the electrodes. This leads to a~     standardized assay for tumour cells with a shorter turnover time and without the need of a~     skilled operator. This system also holds the potential for allowing the molecular~     characterization of CTCs. This study aims to enumerate CTCs using a novel CMOS technology in~     patients with metastatic cancer who are scheduled to receive palliative chemotherapy, and to~     correlate CTC number with clinical outcome. In Part I of the study, the investigators will~     recruit 10 patients with metastatic NSCLC and 10 patients with metastatic CRC in order to~     assess the feasibility of CTC enumeration in patients. In particular, the investigators aim~     to establish whether CTCs are detectable using the novel CMOS technology in patients with~     metastatic cancer. In Part II of the study, the investigators will recruit 21 patients with~     metastatic NSCLC and 89 patients with metastatic CRC in order to compare CTC counts as~     determined by the CMOS technology with CTC counts as determined by the CellSearch platform.~     Blood samples will be collected at a single time point prior to the start of palliative~     chemotherapy. CTC numbers will be correlated with clinical outcome in all evaluable patients.~      The investigators hypothesize that CTC enumeration by a novel CMOS technology is non-inferior~     to CTC enumeration by the CellSearch platform in patients with advanced solid malignancies.~   "
150509|NCT01596439|"~     The primary objective of this prospective pilot study is to examine the variation of~     cognitive function at various time-points in stage I-III breast cancer patients who have~     undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal~     therapy) and compare this to a group of healthy controls to evaluate if there is a~     difference. All randomized patients and their respective controls would be required to~     complete the computerized neuropsychological assessment CANTAB at certain time-points.These~     patients and controls would also be given on the same day as CANTAB testing, a set of~     questionnaires to evaluate subjective factors such as anxiety, depression, fatigue or~     menopausal symptoms which may also have an effect on cognition. Subjective assessment of~     cognitive function will rely on self-reporting by study participants using a validated~     questionnaire.The potential risks to subjects are minimal, as this is a study without any~     intervention regarding the medical management of patients. By participating in this study,~     subjects will be helping in the aim of determining if there is cognitive impairment~     post-therapy, and if so, how prevalent is this phenomenon, when it arises and how it changes~     with time. This will consequentially play an important role with regard to patient knowledge.~     Furthermore, if chemotherapy is shown to be associated with cognitive impairment, further~     studies can be carried out to determine the exact pathophysiology behind this phenomenon.~     This will allow for sensitive and timely detection of cognitive dysfunction in patients who~     have received chemotherapy and/or anti-hormonal therapy, and subsequently open the avenue for~     research in preventing or alleviating this phenomenon. This is crucial in improving patients'~     quality of life, social and occupational performance.~      The investigators hypothesis is that systemic adjuvant therapy in the form of chemotherapy~     and/or anti-hormonal therapy given to primary breast cancer patients can cause cognitive~     impairment.~   "
150510|NCT01596426|"~     The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5~     years.~   "
150511|NCT01596413|"~     The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12~     years.~   "
150512|NCT01596400|"~     The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17~     years.~   "
150513|NCT01596387|"~     The purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model~     to administer propofol in obese patients.~      Our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing~     weight and that mathematical models to administer drugs in obese patients can be developed to~     accurately predict dose schemes in this population.~   "
150514|NCT01596374|"~     Alterations involving the ROS (v-ros UR2 sarcoma virus oncogene homolog 1) gene such as~     mutations, overexpression and gene rearrangements has been implicated in carcinogenesis and~     has been demonstrated to be a relevant target for ALK inhibitors. While emerging reports have~     demonstrated the role of ROS rearrangement in non-small cell lung cancer and~     cholangiocarcinoma, the functional significance of ROS dysregulation in solid tumors remain~     largely unstudied. The investigators aims are: (1) To characterize the frequency of ROS gene~     fusion, ROS protein overexpression and ROS gene mutations in cell lines and tumors from~     patients with hepatocellular carcinoma, colorectal, gastric, breast, ovarian,~     cholangiocarcinoma and non-small cell lung cancer, (2) To identify novel ROS gene variants in~     human solid tumors harboring ROS aberrations using next generation sequencing (NGS), (3) To~     determine the functional relevance of novel ROS gene variants identified with NGS, (4) To~     characterize the sensitivity of cells with functionally relevant ROS aberrations using ROS~     tyrosine kinase inhibitors. ROS fusions and protein overexpression will be screened in a~     panel of cell lines and primary tumors using Fluorescence In-situ Hybridization and~     immunohistochemistry respectively. Targeted next-generation sequencing will be applied to~     identify ROS variants in matching cancer types demonstrating high levels of gene fusion and~     protein overexpression. Functional characterization of novel ROS variants will be performed~     by silencing (shRNA) and overexpressing candidate cell lines with the respective ROS~     mutations/fusions, and evaluating their effects on biological functions including cell~     proliferation, migration, invasion and apoptosis, as well as sensitivity against ROS/ALK~     inhibitors. The investigators anticipate findings from this study will improve the~     investigators understanding of aberrant ROS signaling in an expanded group of cancer types,~     and potentially identifying a larger group of cancer patients that will benefit from ROS~     targeted therapy.~      Further insight of the role of ROS receptor tyrosine kinase will confirm it as a therapeutic~     target in human solid tumors and hence expand the indication of crizotinib and other dual~     ALK/ ROS inhibitors. Furthermore, given the rarity of ROS fusion receptor tyrosine kinase in~     reported cancers, defining the epidemiology of ROS aberrations in other unreported cancers~     harboring ROS pathway activation is essential to properly design future clinical trials of~     ROS inhibitors. The validation of ROS receptor tyrosine kinase will also provide a new~     therapeutic target in the treatment of cancer and expand the role of novel targeted agents.~     Findings from this study will further the investigators knowledge on the oncogenic functions~     of the ROS and the application of ROS inhibitors in an extended group of solid tumors.~   "
150515|NCT01596361|"~     Interethnic variability in chemotherapy response is becoming increasingly evident, making~     approaches for customizing chemotherapy treatment to different ethnic populations desirable.~     At the same time, significant genetic variation has also been observed between ethnic groups,~     including many germline and somatic pharmacogenetic variants involved in chemotherapy~     pharmacology. Recently, based on meta-analyses of studies on germline pharmacogenetic variant~     frequencies and clinical trials, the investigators found that chemotherapy outcomes between~     Asians and Caucasians colorectal cancer (CRC) patients could potentially be inferred from the~     frequencies of variants between the ethnic groups and their respective biological functions.~     In this study, the investigators seek to further clarify the validity of using~     pharmacogenetic variants to customize chemotherapy between ethnicities through the following~     specific aims: (1) To verify the differences observed in the frequency of germline~     pharmacogenetic variants related to chemotherapy between Asian and Caucasian CRC patients,~     (2) To test whether variations in the frequency of somatic pharmacogenetic gene mutations~     between Asian and Caucasian CRC patients could be used to infer differences in clinical~     outcomes between the two ethnicities. (3) (4) For Aim 1, DNA samples from approximately 1000~     Asian and Caucasian CRC patients each will be analyzed for the frequency of a panel of~     germline pharmacogenetic variants identified in our meta-analyses using high-throughput~     methodology. For Aim 2, meta-analyses will be performed on pharmacogenetic studies and~     clinical trials to establish the relative frequencies of somatic variants and clinical~     outcomes in Asian and Caucasian CRC patients. These frequencies will be verified on the same~     series of DNA samples used in Aim 1. The clinical outcomes inferred from the frequency~     differences and biological functions will then be compared to those summarized from clinical~     trials. This data could provide a basis for developing a rational approach to customizing~     chemotherapy in non-Caucasian populations and improve assessment of drug feasibility in~     different ethnic populations.If validated, this working hypothesis would be of high clinical~     interest, giving the opportunity to use this as a DNA prognosis biomarker in CRC.~      Pharmacogenetic frequencies could be a potentially useful approach for predicting likely~     chemotherapy outcomes in non-Caucasian populations~   "
150516|NCT01596348|"~     The purpose of the study is to analyse exercise behaviour of rheumatoid arthritis patients.~   "
150519|NCT01596309|"~     Obesity prevalence in elderly populations has increased in the last years, and the reduction~     of overweight and obesity is a priority target in populations of all age ranges worldwide.~     Obesity is a disease frequently accompanied by a pro-inflammatory state, in which metabolic~     functions may be compromised, and therefore there is a risk of developing comorbidities such~     as type-2 diabetes, hyperlipidemias, hypertension, atherosclerosis, etc. In this context,~     plant extracts are a good source of antioxidant compounds. Among these compounds, polyphenols~     have been shown to have an important antioxidant effect. Scientific evidence based on~     epidemiological studies suggest that flavonoids from the diet play an important role on the~     prevention of cardiovascular disease. Cocoa and related products are an important source of~     flavonoids, providing even more than tea or wine. Generally, benefits associated to cocoa~     consumption are related to the ability for improving lipid profile and insulin sensitivity,~     reducing blood pressure, platelet activity and improving endothelial dysfunction. Some~     studies have also shown an improvement of inflammatory conditions, mainly due to the capacity~     of the polyphenols contained to modify cellular transcription, and the secretion of~     proinflammatory cytokines in peripheral blood mononuclear cells, macrophages and lymphocytic~     strains. Therefore, the hypothesis of this study is that the consumption of cocoa~     extract-enriched prepared meals, within a hypocaloric diet, will help to reduce body weight~     and to improve cardiovascular risk factors compared to the same diet with standard prepared~     meals.~   "
150520|NCT01596296|"~     The purpose of this study is to assess the effectiveness and safety of transcervical foley~     catheter as compared to dinoprostone vaginal insertion for preinduction cervical ripening and~     labor induction in term parous women with unfavorable cervix.~   "
150521|NCT01596283|"~     The purpose of this study is to help us learn what is the best amount of fluid to administer~     to patients during liver surgery. Patients will receive either an amount for this surgery~     based on weight, blood pressure, heart rate and urine output or an amount guided by a~     computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The~     FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on~     real time information like blood pressure, pulse and the ability of the heart and blood~     vessels to maintain normal vital signs.~   "
150522|NCT01596270|"~     Primary Objective:~      - To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a~     day in patients with solid tumors or lymphoma.~      Secondary Objectives:~        -  To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or~          twice a day in patients with solid tumors or lymphoma.~        -  To evaluate the effect of food on blood levels of SAR245409 after administration of~          SAR245409 tablets in patients with solid tumors or lymphoma.~        -  To evaluate the effect of SAR245409 on the body after administration of SAR245409~          tablets once or twice a day in patients with solid tumors or lymphoma.~        -  To obtain information on how SAR245409 administered once or twice a day to patients with~          solid tumors or lymphoma affect disease symptoms and study treatment side effects as~          reported by the patients on a questionnaire.~        -  To explore the antitumor activity of SAR245409 tablets administered once or twice a day~          to patients with solid tumors or lymphoma.~   "
150523|NCT01596257|"~     The purpose of this study is to find out if getting a blood stem cell transplant with donor~     stem cells given over several days is better than getting a blood stem cell transplant with~     donor stem cells given over 1 day. We want to find out which procedure over will result in~     improved recovery of blood and immune function after transplant. When donor stem cells are~     given over various days in mice, the blood and immune system recovery is quicker.~   "
150524|NCT01596244|"~     The purpose of the study is to provide participants in economically depressed areas of Jordan~     essential knowledge, practical skills, and intimate support groups—called microclinics—for~     managing their diabetes. Microclinics consist of 2-8 individuals from pre-existing social~     networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in~     ongoing education and medical monitoring from local health care professionals, learning and~     practicing diabetes management strategies, sharing much-needed medical supplies, and~     exchanging social support in the form of regular micro-clinic meetings.~   "
150525|NCT01596231|"~     This is a study designed to test whether a single administration of kudzu extract (2 mg) will~     significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session~     when given as pretreatment 2 ½ hours before the drinking session.~   "
150526|NCT01596218|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it. It also~     means that the FDA has not approved brentuximab vedotin for the treatment of GVHD.~      Currently, corticosteroids are the standard/first line of treatment for people with GVHD.~     However, some patients do not achieve a good response with steroids and other experience~     flare-ups while tapering steroid treatment. Corticosteroid treatment has also led to a~     weakening of the immune system. For this reason, there have been increased attempts by~     researchers to find other options for the treatment of Graft vs. Host Disease.~      Brentuximab vedotin is a drug that is FDA approved for the treatment of certain types of~     cancers, like Hodgkin's lymphoma. Recent research studies have found increased levels of~     protein called CD30 in people with acute GVHD. Brentuximab vedotin is designed to target~     CD30. Researchers have never tried to target the CD30 molecule for the treatment of GVHD, but~     results from other research studies show that it could help slow the growth of your disease.~      In this research study, we are trying to determine the safest dose of brentuximab vedotin~     that can be given to patients with GVHD.~   "
150539|NCT01596049|"~     This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical~     repair of unilateral inguinal hernia, which is becoming the new standard of care in open~     surgical repair of inguinal hernia.~      The study design is interventional, enrolling 300 patients above 18 years of age, admitted~     for elective repair in the surgical department of Rambam Medical Health Care Campus, an~     academic medical center.~      The study will assess several outcomes including post-surgical pain, recurrence, quality of~     life and post surgical complications (e.g. wound infection, the formation of hematoma or~     seroma, etc).~   "
172847|NCT01302704|"~     The purpose of this study is to demonstrate if Proton Pump Inhibitors (PPI's) decrease blood~     levels of 25-Hydroxyvitamin D (25-OH Vitamin D).~   "
150527|NCT01596205|"~     Previous studies about cognitive intervention targeting older adults revealed that cognitive~     training had effects on the improvement of cognitive function.However, researches are rare~     that investigated direct changes of brain structures after cognitive training.~      The advanced scientific technique allowed us to develop service robots designed to assist~     human work, which can be important with an increase in the aging population and high costs of~     elderly care. In this regard, the investigators considered robots for elderly's cognitive~     training and developed 17 cognitive programs in collaboration with Center for Intelligent~     Robotics at Korea Institute of Science and Technology.~      The purposes of this study were to demonstrate the effects of the investigators newly~     developed robot assisted group cognitive training programs on the brain in older adults and~     to identify whether they can help to improve cognitive function or mood in the elderly~     compared to the conventional cognitive training or control group that were not involved in~     any cognitive training.~   "
150528|NCT01596192|"~     Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing~     allogeneic hematopoietic cell transplantation. 18F-FDG PET/CT (2-[fluorine-18]~     fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that~     allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake~     is caused by increased local metabolic activity. In this study, we aim to evaluate and~     characterize the correlation between CT-PET findings in patients suspected to have acute~     GVHD, and the disease course.~   "
150529|NCT01596179|"~     The purpose of the Technology Enhanced Nurse Navigator Trial (TENN) Trial is to find the best~     way to provide breast cancer patients with information through a computer connected to the~     internet. The study will determine if giving information during treatment may help patients~     cope better with their treatment. The hypothesis is that participants assigned to receive~     Technology-Enhanced Nurse-directed Navigation will be more likely to adhere to treatment~     regimens and have improved symptom management than women who have access to the education~     portal only.~   "
150530|NCT01596166|"~     Migraine headaches are a common problem for children. When treatment at home fails, children~     may benefit from intravenous treatment administered in a hospital setting like the Emergency~     Department. Most treatments used however have only been tested in adults and the best~     treatment strategy for children is not always clear. The combination of more than one~     medication is frequently prescribed in Canadian Emergency Departments. The purpose of this~     study is to investigate whether the combination of ketorolac (an anti-inflammatory pain~     medication) and metoclopramide (an anti-nauseant that may also relieve migraine headaches) is~     better than metoclopramide by itself.~   "
150531|NCT01596153|"~     The purpose of this study is to compare the effect of enhanced probiotic (EP, Live Rx) versus~     placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or~     antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.~   "
150532|NCT01596140|"~     The goal of this clinical research study is to find the highest tolerable dose of vemurafenib~     that can be given in combination with either everolimus or temsirolimus. The safety of these~     drug combinations will also be studied.~      Vemurafenib is designed to block BRAF inside the cancer cells, which is a mutation that is~     involved in cancer cell growth.~      Temsirolimus and everolimus are designed to block the growth of cancer cells, which may cause~     cancer cells to die.~   "
150533|NCT01596127|"~     The goal of this clinical research study is to learn about the safety and effectiveness of~     rituximab given by spinal tap in patients with lymphoid malignancies involving the central~     nervous system.~      A spinal tap (also called a lumbar puncture) is when fluid surrounding the spinal cord is~     collected by inserting a needle into the lower back. The affected area is numbed with local~     anesthetic during the procedure. It will also be used to give chemotherapy in this study.~      Rituximab is designed to bind to a protein, called CD20, that is on the surface of the~     leukemia cells. This may cause the leukemia cells to die.~   "
150534|NCT01596114|"~     The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of~     molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase~     Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response~     (MMR) or better after stopping TKI therapy.~      Secondary goals include:~        -  Identification of clinical and biological factors affecting the persistence of complete~          molecular remission after stopping TKI (e.g. level of Complete molecular remission~          (CMR), risk score, duration of TKI treatment, type of TKI pretreatment)~        -  Evaluation of quality of life (QoL) in patients stopping TKI~        -  Evaluation of medico-economic impact of stopping TKI~        -  Estimating the number of patients in CMR who are eligible for stopping TKI therapy by~          setting up a screening log~        -  Time to recovery of CMR There will be no randomised comparison. Based on the experience~          of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month~          molecular-relapse-free survival probability of at least 40%. An interim analysis will be~          performed after a pilot phase where 200 patients have been observed for at least six~          months. Formally, it is planned to test the null hypothesis H0: Six-month molecular~          relapse-free survival probability P ≤ 40% against the alternative hypothesis H1:~          Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML~          patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log~          reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by~          a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be~          performed during 3 years: Associated scientific projects are performed. Recruitment~          period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500~   "
150535|NCT01596101|"~     Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children~     admitted to the burn intensive care unit.~   "
150536|NCT01596088|"~     The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in~     the treatment of accidental extravasation of anthracycline anti-cancer agents.~   "
150537|NCT01596075|"~     Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing~     allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the~     incidence of acute GVHD is estimated at 40-60% among patients receiving transplants from~     HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched~     unrelated transplants. More effective prevention and treatment strategies are needed.~      The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in~     animal models of various inflammatory diseases including multiple sclerosis, inflammatory~     bowel disease and rheumatoid arthritis.~      Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and~     immunosuppressive effects.~      As such, it may be effective for both prevention and treatment of acute GVHD after allogeneic~     stem cell transplantation.~   "
150540|NCT01596036|"~     The purpose of this study is to test if an early appointment (within 10 days) when compared~     to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation~     orientation and subsequent enrollment into cardiac rehabilitation.~   "
150544|NCT01595984|"~     The main objective of this protocol is to compare the impact on renal function of two~     different immunosuppressive regimens in patients with de novo renal transplant.~      Renal function will be accurately evaluated by measuring the clearance of iohexol.~      The protocol will also evaluate the efficacy and safety in a short term of these two~     different immunosuppressive regimens.~   "
150545|NCT01595971|"~     The purpose of this study is to evaluate the effectiveness of multifaceted educational~     interventions in the care of asthma, conducted remotely over the platform TelessaúdeRS in~     teams of the Family Health Strategy and the consequent clinical improvement patients.~   "
150546|NCT01595958|"~     The investigators hypothesised that cyclosporine A administration at the onset of~     cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore,~     could prevent the post cardiac arrest syndrome and improve outcomes.~   "
150547|NCT01595945|"~     Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even~     after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is~     still unclear. Lower resting metabolic rates were also reported after gastric banding~     bariatric surgery but have not yet been investigated in subjects after gastric bypass. The~     purpose of this study is to investigate the consequences on resting metabolic rate in~     subjects with obesity after moderate caloric restriction or gastric bypass.~   "
150548|NCT01595932|"~     The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in~     pediatric patients with predominant gas-related symptoms.~   "
150549|NCT01595919|"~     The objective of the current study is to determine the effects of an ad libitum intake of 1%~     milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food~     intake, appetite and postprandial blood glucose in healthy men and women. We hypothesize that~     1% milk will reduce food intake and result in better post-meal glycemic response compared to~     the other beverages.~   "
150550|NCT01595906|"~     The use of infantry helmets under heavy heat stress conditions, during physical exertion, may~     hinder the body's ability to effectively dissipate heat from the head area, thereby damaging~     the soldier's function. Therefore head cooling may potentially enable a longer duration of~     activity until reaching fatigue. An improvement in function may also be possible.The purpose~     of this research is to determine the extent of the cognitive and physiological strain caused~     by wearing a helmet under exertional conditions while exposed to heavy heat stress and to~     evaluate the effect of a unique ventilation system connected to the helmet on strain~     reduction.~   "
150551|NCT01595893|"~     Polymorphic light eruption (PLE) is a common photodermatosis with a high prevalence of~     approximately 11 to 21% in the population. Similar to lupus erythematosus (LE), an~     UV-inducible systemic autoimmune disease, PLE has a female preponderance with a mean onset in~     the second to third decade of life. PLE lesions are very itchy and typically appear on~     sun-exposed body sites in spring or early summer. The quality of life in patients with PLE is~     often severely disturbed, as evidenced by high levels of anxiety and depression. For~     prophylaxis besides conventional sunscreens, photo(chemo)therapy is effective in many cases,~     when administered over several weeks for hardening in early spring before the first natural~     sun exposure takes place. However, because prolonged treatment with UVB and/or~     photochemotherapy is potentially carcinogenic, the search for pathogenic mechanisms and new~     treatment options in PLE is ongoing. The exact pathogenesis of PLE is currently unknown but~     findings suggest an autoimmune-type background with resistance to UV-induced immune~     suppression and simultaneous immune reactions against skin photo-neoantigens. The~     investigators have recently found that PLE patients had significantly reduced~     1,25-(OH)2-vitamin D3 serum levels (13-14ng/ml) compared to the normal population (>30ng/ml).~     In addition, the investigators were able to demonstrate in an intra-individual half-body~     trial that topical administration of an immunostimulatory 1,25-(OH)2-vitamin-D3 analogue~     calcipotriol reduced PLE symptoms in an experimental study. In the proposed randomized~     double-blinded placebo-controlled trial the investigators attempt to study the effect of oral~     vitamin D3 supplementation (2 x 40.000 IE, given orally two weeks apart) on PLE symptoms.~   "
150552|NCT01595880|"~     This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of~     gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component~     administered alone in healthy male volunteers.~   "
150553|NCT01595867|"~     This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study~     designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine~     sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid~     users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be~     selected during Part A of the study (Dose Selection Phase). Each subject participated in the~     study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to~     12 nights.~   "
150554|NCT01595854|"~     Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new~     pharmacodynamic methods~   "
150555|NCT01595841|"~     Dialysis patients presenting for angioplasty intervention for graft failure will be~     randomized to receive either Sirolimus or not receive Sirolimus (standard of care) to assess~     the time from primary failure or angioplasty intervention to second or next angioplasty~     intervention or graft failure.~   "
150556|NCT01595828|"~     The purpose of this study is to examine in detail the acute and chronic effects of~     pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk~     for the premature development of atherosclerosis (CAPITAIN).~   "
150557|NCT01595815|"~     Artificial oocyte activation with strontium chloride or calcium ionophore improves~     fertilization, embryo quality, pregnancy and delivery rate in women who showed complete~     fertilization failure or low fertilization rates~   "
150558|NCT01595802|"~     The purpose of the study is to determine the sensitivity, specificity and predictive values~     of the Jan Medical NeuroWave System in detecting moderate and severe vasospasm in comparison~     to Trans Cranial Doppler(TCD).~   "
150599|NCT01595269|"~     This project addresses the following Null Hypotheses:~        1. There will be no difference will be found in the use of the search engine and the~          information accessed among the three education modes.~        2. There will be no difference in education mode's effect on metabolic control, self-care~          management practices, and medical resource utilization.~        3. There will be no difference in the economic impact on the health care system based on~          differing education modes.~   "
150559|NCT01595789|"~     The purpose of this study is to investigate the effect of combined glucagon-like-peptide-1~     (GLP-1) analogue and metformin therapy on glucose metabolic and cardiovascular endpoints~     compared to metformin monotherapy in patients with coronary artery disease (CAD) and newly~     diagnosed type 2 diabetes (T2D).~      It is hypothesized that GLP-1 analogue added to backbone therapy of metformin in CAD patients~     with T2D will improve beta-cell function, left ventricular ejection fraction (LVEF), heart~     rate variability and lower 24h blood pressure among other selected endpoints.~      The present study on CAD patients with newly diagnosed T2D will address these selected~     endpoints during an investigator initiated, randomized, double blind, crossover,~     placebo-controlled 12 + 12 weeks intervention study with a 2 week wash-out period.~   "
150560|NCT01595776|"~     Aim: to value the safety and efficacy of local intramuscular administration of immunoselected~     autologous endothelial progenitor cells in the treatment of critical limb ischemia in~     patients without revascularization options.~      Primary goal: to value the feasibility of mobilization, harvesting, immunoselection and auto~     transplantation of endothelial progenitor cells.~      Secondary goal: to value the efficacy of local administration of autologous endothelial~     progenitor cells in the treatment of critical limb ischemia~   "
150561|NCT01595763|"~     To asses the cost-effectiveness of implementing different diagnostic strategies in patients~     with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in~     primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care.~     To describe the differential diagnosis and the strength of association between each outcome~     variable and the clinical prediction guide and the final diagnosis. It is a cross-sectional,~     multicentric study.~   "
150562|NCT01595750|"~     REVASC is a randomized, double-blind, placebo-controlled study which will involve 150~     patients with chronic bronchitis and COPD diagnosed cardiovascular disease. The recruitment~     period beginimg in the coming weeks, will last nine months. Patients included in the study~     will receive treatment for three months with roflumilast 500 mg (75 patients) or placebo (75~     patients) in a randomized manner. The CIBERES, as promoter of this study is expected to~     release final results for the third quarter of 2013.~      Eight centers in Madrid will be involved in this clinical trial: Fundación Jiménez Díaz,~     Hospital La Princesa, Hospital Gregorio Maranon Hospital Clinico San Carlos, Hospital La Paz,~     Hospital Ramón y Cajal Hospital Doce de Octubre and Hospital Puerta del Hierro.~      Roflumilast is a potent phosphodiesterase-4 inhibitor (PDE4). Its clinical efficacy has been~     studied in an extensive clinical program involving over 12,000 patients with COPD. In these~     studies, roflumilast (in combination with long-acting bronchodilators) reduced the number of~     exacerbations and improved lung function, especially in those patients with associated~     chronic bronchitis.~   "
150563|NCT01595737|"~     This study aims to examine the efficacy of levosimendan in terms of reducing postoperative~     mortality and severe morbidity in patients undergoing non-emergent surgery for coronary~     revascularisation with or without ischaemic mitral regurgitation and who may or may not~     require repair or replacement of the mitral valve and have a LVEF < 35%.~   "
150564|NCT01595724|"~     The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d)~     on the Endometriosis related quality of life. These data will be collected using a special~     patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to~     describe the basic disease status and demographic characteristics of patients searching~     treatment by a gynecologist because of their endometriosis. In addition, the study will give~     insight into the typical diagnostic measures the physicians in different countries are using~     in the field of endometriosis.~   "
150565|NCT01595711|"~     The skin conductance algesimeter (Pain Monitor™, Med-Storm Innovation AS, NO-0264 Oslo,~     Norway)) reflects the sympathetic nervous system by the measurement of the skin conductance~     of the palm of the hand. SCA detects nociceptive pain fast and continuously, specific to the~     individual, with higher sensitivity and specificity than other available objective methods.~      The skin conductance response to a calibrated noxious stimulus varies among patients. It~     defines two types of people depending on its magnitude.~      The investigators assume that the importance of skin conductance response to a noxious~     stimulus predicts the occurrence of chronic pain in patients operated by thoracotomy.~   "
150566|NCT01595698|"~     Schizophrenia is a severe mental illness, of psychosis being the most prevalent in society,~     affecting 1% of the population. The treatment of schizophrenia is basically done with~     antipsychotic drugs, although other non-pharmacological interventions, such as exercise, a~     form of treatment seems to be considered. Among the most recommended exercise for the general~     population, the investigators highlight the aerobic and resistance exercises. However, few~     studies have reported the positive effect of aerobic exercise in the pathogenesis of~     schizophrenia. In relation to resistance exercise, it is unknown if the effect in patients~     with the disease, especially when one considers the junction of the two types of exercises in~     the same training session (called concurrent training). However, it is known, through~     clinical studies and animal models, that exercise modifies the brain improves~     neuroplasticity, the mental condition of the individual frames and reverses~     neurodegeneration. Associated with improvement in schizophrenia, few clinical trials of~     aerobic exercise showed improvement in disease symptoms, reducing anxiety and depression, and~     clinical global improvement. The hypothesis is that the types of proposed training, aerobic~     training, resistance training and concurrent training can improve clinical symptoms of the~     disease, and improve the side effects caused by drugs. It is believed that the clinical~     changes are accompanied by increased serum IGF-1 by resistance training and aerobic training~     by BDNF.~   "
150600|NCT01595256|"~     The aims of this four-year study are to~        1. explore the relationships between fatigue and muscle strength (i.e., upper limbs and~          lower legs)~        2. comparison with the effects of 8-week, 12-week moderate intensity of walking program on~          muscle strength and fatigue.~        3. develop a clinical guidelines of home-based walking program for patients with colorectal~          cancer receiving active treatment and survivors in Taiwan.~        4. explore the relationships among the self-report fatigue intensity and metabolism.~   "
150601|NCT01595243|"~     The aims of this three-year study are to:~        1. From patients and family perspective to explore the needs for home care after receiving~          TACE, PEI, and RFA~        2. Develop a telephone follow-up and consultation program and examine its effect on~          self-efficacy, anxiety, depression and quality of life in liver cancer patients~          receiving non-surgical treatment.~   "
150567|NCT01595685|"~     The goal of chronic hepatitis B (CHB) treatment is complete and permanent eradication of~     hepatitis B virus (HBV) from patient's body, which is best represented by serum HBsAg loss~     accompanied by undetectable serum HBV DNA level.~      While the most recently approved nucleos(t)ide analogues (NA) have marked antiviral potency~     and can induce HBV DNA undetectability in the majority of patients through prolonged~     treatment, NA need to be given long term, almost indefinitely, in most cases because they~     suppress HBV DNA only during therapy. For example, even after HBeAg-loss by a potent NA,~     suppression of serum HBV DNA to undetectable level is sustained only in about 23%-37% at 24~     weeks off treatment. Thus, continuous therapy with NA until HBsAg clearance remains necessary~     in a majority of cases.~      The recent availability of commercial quantitative assays of serum hepatitis B surface~     antigen (HBsAg) has enabled quantitative HBsAg to be used as a biomarker for prognosis and~     treatment response in CHB. It has been suggested that HBsAg decline during lamivudine or~     entecavir therapy is slower and less pronounced compared to interferon treatment, despite a~     higher effect on HBV DNA suppression. Based on HBsAg kinetics, it has been estimated that the~     predicted median time to HBsAg loss in patients treated with lamivudine or entecavir is more~     than 30 years. Thus, treatment that can induce rapid decline of HBsAg would have clear~     advantage in reducing the treatment duration required to achieve HBsAg-loss.~      Interestingly, in a recent preliminary study, 24-weeks of treatment with telbivudine has~     induced HBsAg decline as comparable to pegylated interferon treatment. Although there has~     been no head-to-head trial comparing NAs in inducing HBsAg decline, previous studies~     consistently suggested that the decline of HBsAg is greater during telbivudine treatment~     compared with lamivudine or entecavir.~      Thus, in this clinical trial, the investigators will investigate whether telbivudine is more~     effective in inducing HBsAg decline compared with entecavir in HBeAg-positive CHB patients~     who have achieved undetectable serum HBV DNA by preceding entecavir treatment.~   "
150568|NCT01595672|"~     The purpose of this study is to determine the effect and safety of early high-volume~     continuous veno-venous hemofiltration for patients with severe acute pancreatitis.~   "
150569|NCT01595659|"~     Among the many risk factors that contribute to young drivers' crash involvement, two are~     critical: peer passenger presence, which is unique to young drivers, and the influence of~     alcohol, a universal risk for drivers but one against which young drivers are most~     susceptible. Clarification of how passenger presence interacts with alcohol consumption to~     increase risk is needed. The impact of experimentally manipulated passenger characteristics~     and alcohol quantity on risky driving is observed using driving simulation and a random~     assignment experimental design with a sample of 18-21 year old male and female drivers.~   "
150570|NCT01595646|"~     The study will examine the effects of intranasally administered long-acting insulin detemir~     on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment~     (aMCI). The rationale for these studies is derived from growing evidence that insulin~     contributes to multiple brain functions, and that insulin dysregulation can contribute to AD~     pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have~     beneficial effects on brain function. Intranasal administration of insulin increases insulin~     signaling in the brain without raising peripheral levels and causing hypoglycemia. Insulin~     detemir is an insulin analogue that may have better action in brain than other insulin~     formulations because of its albumin binding properties. The investigators will test the~     therapeutic effects of intranasally-administered insulin detemir in a study in which~     participants will receive insulin detemir, regular insulin, or placebo over a four month~     period. The investigators will test the hypothesis that insulin and insulin detemir will both~     improve memory and daily functioning in persons with AD/aMCI compared with placebo, but that~     insulin detemir will have the greatest effect.~   "
150571|NCT01595633|"~     In Korea, the number of suboptimal responders to rescue combination therapy is also~     increasing. As a matter of fact, according to the investigations in Korea, HBV DNA~     undetectability at 48 weeks of adefovir and lamivudine combination rescue therapy for~     patients with lamivudine resistance was reported to be only 32.4%, which suggested that the~     appropriate another rescue therapy might be urgently required. However, there is no promising~     oral antiviral agents to control these patients in Asia-Pacific region, where tenofovir is~     not widely available. Tenofovir has a higher potent antiviral efficacy and a negligible drug~     resistance rate. The switch from adefovir to tenofovir in patients who have insufficient~     hepatitis B virus (HBV) suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to increased viral~     suppression or more HBeAg loss/seroconversion.~      Here, the investigators aimed to conduct a randomized study on evaluating the antiviral~     efficacy, safety, and tolerability of switching from adefovir to tenofovir in chronic~     hepatitis B patients who have suboptimal response to adefovir-based combination rescue~     therapy due to nucleoside analogues Resistance (SATIS study).~   "
150572|NCT01595620|"~     The purpose of this study is to test the effects of cannabinoids on pain response using a~     variety of human experimental pain models.~   "
150573|NCT01595607|"~     The study will investigate the effect of avocado consumption on markers of vascular health.~     Sixty participants will be enrolled in the 6-week study. A randomized parallel design will be~     utilized. Participants will either receive a typical American diet, or a modified typical~     American diet in which avocado is substituted for foods that contain moderate and high~     amounts of saturated fat, to allow the isoenergetic inclusion of avocado.~   "
150574|NCT01595594|"~     The objective of this study is to evaluate Photodynamic Therapy (PDT) as adjunct on non~     surgical periodontal therapy in patients with type 2 diabetes. A total of 40 individuals will~     be selected and divided in two groups. On the treatment stage, the control group (Group C)~     will receive standard non surgical periodontal treatment. The Test Group (Group T) will be~     treated with PDT as an adjunct to non surgical periodontal treatment. The treatment will be~     repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until accomplish~     3 months. The follow-up will be done for 6 months. The clinical parameters measured will be:~     plaque index, pocket depth, bleeding on probing, relative clinical insertion level and~     suppuration. In addition, the evaluation of crevicular fluid volume and the levels of IL-1,~     TNF-α, subgingival microbiota by the hybridization DNA-DNA Checkerboard technique. The~     investigators expect to find identical or better results for the test group.~   "
150575|NCT01595581|"~     This study is being done to test whether taking testosterone can prevent loss of muscle mass~     and strength due to anterior cruciate ligament (ACL) reconstructive surgery. Testosterone is~     the principal male sex hormone and an anabolic (muscle promoting) steroid. It is essential~     for the development of male reproductive tissues and promotes increased muscle, bone mass,~     and the growth of body hair.~      The investigators hope to learn whether testosterone given before and after ACL~     reconstructive surgery will increase muscle mass and strength and potentially improve~     recovery time following surgery.~   "
150602|NCT01595230|"~     The purpose of this study is to determine whether closure of all mesenteric defects with~     clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction-~     internal hernias~   "
150603|NCT01595217|"~     Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI~     sequence with MRCP versus MRCP only separately.~   "
150576|NCT01595568|"~     In adolescents, mental health problems are frequently associated with substance misuse, even~     considered a risk factor for alcohol abuse and dependence. This dual diagnosis tends to~     complicate the patient's treatment and prognosis by increasing, among others, substance use~     problems, reckless behaviours, relationships and school problems and suicidal thoughts. It is~     therefore critical to invest time and effort into developing an efficient approach to prevent~     and reduce substance use problems and offer these children a more global and optimal~     treatment.~      A brief personality-targeted intervention was developed with students of Canadian and English~     high schools based on four personality factors known to be implicated in the vulnerability to~     adolescent alcohol misuse (Impulsivity, Anxiety Sensitivity, Negative Thinking and Sensation~     Seeking) (Conrod et al., 2006,2008, O'Leary-Barrett 2010).~      By helping the adolescents to develop better adaptive behaviours, this cognitive-behavioural~     intervention proved to reduce binge drinking, quantity and frequency of use and substance use~     problems (Conrod et al., 2006,2011).~      The purpose of this study is to assess the impact of this intervention if combined to a~     regular treatment in a youth psychiatric population.~      60 patients aged 14-17 years of a Child and Adolescent psychiatric department will be~     screened for personality risk with self-report assessments including the Substance Use Risk~     Profile Scale. Participants will be randomly assigned to a personality matched~     cognitive-behavioural intervention or a no-intervention control.~      The main outcome measures of this study are alcohol and illicit drug outcomes. Secondary~     measures include mental health symptoms.~   "
150577|NCT01595555|"~     This research will examine whether an Internet-based mindfulness program for stress~     management produced positive outcomes for participants and is technologically feasible~   "
150578|NCT01595542|"~     The study will evaluate a health services intervention to increase uptake of adolescent~     vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five~     school health centers by improving the consent process for parents.~   "
150579|NCT01595529|"~     The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled~     non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672~     will be evaluated for the study's primary outcome measure. After the first 5 days of primary~     care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic~     will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same~     antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days~     total). The primary objective of this study is to determine if halting antimicrobial therapy~     in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy~     (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14~     as subjects who continue to take antibiotics for an additional 5 days (standard course~     therapy).~   "
150580|NCT01595516|"~     The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult~     humans with elevated blood pressure to a greater extent than either metoprolol or placebo.~     The investigators further hypothesize that the improvement in the capacity of the vascular~     endothelium to release t-PA with nebivolol is mediated, in part, by the compound's~     antioxidant properties.~   "
150581|NCT01595503|"~     Repetitive transcranial magnetic stimulation (rTMS) is a new noninvasive therapy that uses~     magnetic energy applied to the scalp to modulate activity in the underlying regions of the~     brain. In this study we will examine the efficacy of treating auditory hallucinations in~     schizophrenia with rTMS, comparing two methods to target stimulation to a language processing~     region of the brain. One method targets the stimulation site using scalp landmarks, while the~     other uses functional magnetic resonance imaging (fMRI) combined with a language task.~   "
150582|NCT01595490|"~     The objective of this study is to determine whether participation in a mind-body skills~     program by war-traumatized adolescents in Gaza will result in improvement of posttraumatic~     stress symptoms, depression, and levels of aggression compared to a control group.~   "
150583|NCT01595477|"~     The objective of this study is to determine whether participation in a mind-body skills~     program by war-traumatized children in Gaza will result in improvement of posttraumatic~     stress symptoms, depression, and decreased hopelessness compared to a control group.~   "
150584|NCT01595464|"~     The objective of this study is to determine whether participation in a mind-body skills~     program by war-traumatized adults in Gaza will result in improvement of posttraumatic stress~     symptoms and depression, and will increase posttraumatic growth compared to a control group.~   "
150585|NCT01595451|"~     We are doing this study to investigate the effects of acupuncture on chronic low back pain.~     We are interested in learning about brain activity during pain. We plan to look at brain~     activity at the beginning and the end of the study, after 6 sessions of acupuncture~     treatment. You will be randomly assigned to one of two groups to receive either real or~     placebo acupuncture.~      Acupuncture has been used for many years to help relieve pain. However, it is not clear how~     acupuncture works. Acupuncture may relieve pain by changing activity in the nervous system.~     Some studies indicate that acupuncture may relieve the low back pain. However, we need more~     research to see how well acupuncture works to relieve pain for people with this condition.~      In this study, we will measure your brain activity before and after you do exercises to make~     your back pain worse. We will also measure your brain activity while inflating a pressure~     cuff device on your lower leg. We will measure this brain activity using a research tool~     called functional MRI (fMRI). Functional MRI is a very fast MRI that uses radio waves and a~     magnet, and allows the study investigators to look at changes in blood flow to different~     parts of the brain when there are changes in brain activity.~   "
150586|NCT01595438|"~     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to~     Doripenem for treating hospitalized patients with complicated urinary tract infections,~     including acute pyelonephritis~   "
150587|NCT01595425|"~     This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC~     capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of~     these two formulations in healthy male Japanese subjects.~   "
150636|NCT01594775|"~     effects of intranasal oxytocin and couple interaction on wound healing.~        -  Trial with medicinal product~   "
150637|NCT01594762|"~     The purpose of this study is to establish the clinical superiority and the safety of topical~     pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus~     standard local wound care, in the treatment of mildly infected diabetic foot ulcers.~   "
150588|NCT01595412|"~     Background:~      Rectal prolapse (RP) is the descent of the upper rectum and is a common problem in the~     western world. Surgery is the only definite treatment and is preferably performed minimally~     invasive. High-level prospective studies on treatment strategies for RP currently are lacking~     and, thus, no consensus exist regarding the optimal treatment for patients with RP.~     Furthermore, remarkable transatlantic differences exist, as in Europe, laparoscopic ventral~     rectopexy (LVR) is regarded the treatment of choice, while in the USA Laparoscopic Resection~     Rectopexy (LRR) remains the golden standard.~      Objective:~      To determine the optimal minimally invasive surgical treatment for patients with RP.~      Design:~      International, prospective, comparative double cohort study. The first cohort will consist of~     120 European patients with a RP and will be treated with LVR. Centres in The Netherlands,~     Belgium and the UK are enlisted for participation. The second cohort will consist of 120~     American patients with a RP, treated with LRR. Several US centres are enlisted. Preoperative~     work-up consists of radiological imaging and standardised questionnaires. Follow-up (FU) is~     set on two years. During FU, pre-operative imaging and questionnaires will be repeated.~      Primary & secondary outcomes:~      Primary endpoint will be improvement on the Gastro-Intestinal-Quality-of-Life-Index (GIQLI).~     Secondary endpoints will be generic Quality-of-Life, functional results, morbidity,~     mortality, recurrences and cost-effectiveness.~      Time frame:~      Study and inclusion start will be on January the 1st, 2011 and will take approximately 18-24~     months. Therefore, total study duration will be 42-48 months.~   "
150589|NCT01595399|"~     The purpose of this study is to compare heart rate in infants who receive atropine as a part~     of their medication before intubation to those who do not.~      To be able to find out , we need to divided babies into 2 groups;~      group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline (~     placebo group) + sedation + muscle relaxant~      Then we need to compare heart rate during intubation and duration of intubation between the 2~     groups.~   "
150590|NCT01595386|"~     This protocol is designed to offer insight into critical illness related corticosteroid~     insufficiency and steroid supplementation in neonates undergoing cardiac surgery with~     cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative~     period.~   "
150591|NCT01595373|"~     The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are~     healthy young men. End points are interstitial concentrations of glucose, lactate, and~     glycerol.~   "
150592|NCT01595360|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in~     healthy volunteers after tooth extraction.~   "
150593|NCT01595347|"~     Pressure ulcers (UPP) represent an important sanitary problem affecting mostly elderly~     immobilized persons, increasing the burden of care to professionals in the health system, as~     well as pharmaceutical spending. There are studies of the effectiveness of various products~     in the prevention of the UPP, most made in hospitals and using fundamentally composed based~     on oily hyperbecome oxygenated acids (AGHO).~      There do not exist studies realized specifically with cream of olive oil.~      AIMS:~      Principal: To verify the efficiency of a new intervention of UPP's prevention in immobilized~     patients consisting in the application of cream of olive oil. Secondary: To evaluate the cost~     - efficiency of this new intervention opposite to AGHO's application.~      To value the degree of satisfaction of the patient and his keeper with regard to the use of~     cream of olive oil.~      METHODOLOGY DESIGN: clinical Test randomized with two parallel branches. AREA: Population~     consultant of the health centers in the province of Malaga. SUBJECTS OF STUDY: Patients~     immobilized at the risk of developing UPP. INTERVENTION: Administration of cream of olive oil~     to the group of intervention and AGHO's administration to the group control. Follow-up for~     one year. VARIABLES. Principal variable: UPP's appearance. Secondary: Demographic and~     clinical data, presence of technical supports, information of the caragiver and questionnaire~     of satisfaction. STATISTICAL ANALYSIS: Test. Exact of Fischer. Odds's calculation ratio.~     Shapiro-Wilk's test. Parametric test t- student or test U of Mann-Whitney. Reason of the~     increase cost efficiency (ICER). Logistic regression model multivariant.~   "
150594|NCT01595334|"~     1. Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions~          during menstrual cycle at appropriate plasma levels'~        2. In early follicular phase,in the requisite range,LH is known to contribute to maturation~          of oocyte during transition phase from metaphase-1(M1) to metaphase-2 (M2).~        3. If during this transition, appropriate level of LH can be maintained either through the~          use of gonadotropin releasing hormone (GnRH) antagonist if found excessive or~          supplementation with exogenous LH, if found deficient, maturation process can be~          enhanced.~        4. Further maintenance of suitable combination of recombinant follicle stimulating hormone~          (rFSH) + rLH can help in realizing higher yield of mature M2 oocytes,with higher~          probability of establishing clinical pregnancy.~   "
150595|NCT01595321|"~     The purpose of this study is to estimate safety of a whole cell vaccine with immune~     modulating doses of cyclophosphamide followed by SBRT and FOLFIRINOX chemotherapy in~     pancreatic cancer patients after surgery.~   "
150596|NCT01595308|"~     How daily consumption of pomegranate juice affects the concentration, morphology or motility~     of sperm in healthy men.~   "
150597|NCT01595295|"~     This registry is set up to collect real-world experience in the management of patients with~     myeloid neoplasms, in particularly in patients with MDS, CMML or AML, treated with~     hypomethylating agents in Austria and potentially other participating countries. This~     registry will collect data in a retrospective as well as in a prospective manner at various~     sites. The aim is to gain valuable insights on both efficacy and toxicity of these drugs in a~     routine clinical setting in patients with various comorbidities.~   "
150598|NCT01595282|"~     The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on~     immediate post-procedural pain scores in patients undergoing first trimester suction~     curettage with local anesthesia only.~      Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an~     approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately~     after the procedure.~      Secondary hypotheses include:~        -  Pain scores on the 21-point scale will also be significantly lower in the ketorolac~          group immediately after cervical dilation and 15 minutes post-procedure.~        -  Fewer patients in the ketorolac group will rate their pain as severe on a subjective~          pain rating scale.~        -  Patients in the ketorolac group will be more satisfied with their pain control.~        -  Side effects will be similar between groups.~   "
150604|NCT01595204|"~     Prospective multicenter study that aims to evaluate the learning curve of a laparoscopic~     score to predict possibility of optimal cytoreduction in patients with ovarian / tubal /~     peritoneal advanced at the time of first surgery. The study consists of subjecting all~     patients with a clinical suspicion and / or radiological diagnostic laparoscopy (SLPs).~      Laparoscopy should be described and recorded in electronic form. After the procedure each~     patient will have a Laparoscopic-evaluation-form filled up with a laparoscopic score (PI).~     The minimum number of cases to be enrolled is 10 patients, in a minimum time of 1 year. The~     data collected and the video should be sent to the Center Coordinator, who will determine the~     adequacy of the procedure and the accuracy of the score enrollment is completed for each~     center. All eligible subjects will be considered by intention-to-treat population (ITT). For~     this phase of the study, it is not necessary know the outcome of the surgical patient (RT) or~     if it was then subjected to exploratory laparotomy or less.~   "
150605|NCT01595191|"~     Exposure to Mozart music significantly lowers resting energy expenditure (REE) in healthy~     preterm infants. Whether this finding is related to music per-se or to music by Mozart is~     unknown. The objective is to study whether J.S. Bach music has a lowering effect on REE~     similar to that of Mozart music.~   "
150606|NCT01595178|"~     Smoking and drinking are two of the three leading causes of preventable deaths in the United~     States today. Using both alcohol and tobacco significantly multiplies the risk of disease and~     death from myocardial infarction, COPD, and multiple cancers. Combined use of these~     substances is extremely common; people who drink are three times more likely than the general~     population to smoke, and tobacco dependent individuals are four times more likely than the~     general population to be alcohol-dependent.~      Research has shown that there is a high prevalence of unmet substance abuse treatment need~     among adult Emergency Department (ED) patients. The current project aims to conduct a pilot~     feasibility study with 50 adult ED patients to develop a brief counseling intervention that~     is feasible and acceptable to patients who are both smokers and at-risk drinkers to help them~     reduce these behaviors.~      The overarching aim of this line of research is to find the best treatment for ED patients~     who are combo smokers and at-risk drinkers. The study will focus on the development of an~     intervention that will be tested in a future larger scale randomized clinical trial.~   "
150607|NCT01595165|"~     Transversus abdominis plane (TAP) block has gained popularity for the control of~     postoperative pain in various surgeries. Three studies showed inconsistent result on pain~     control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these~     studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid~     incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely~     extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The~     investigators are going to investigate the effect of subcostal TAP on early postoperative~     pain after laparoscopic cholecystectomy.~   "
150608|NCT01595152|"~     Hypothesis:~      Objective 1: To advance the investigators understanding on the effect of solifenacin~     succinate (10 mg OD) vs. fesoterodine (8mg OD) on urinary urgency using a validated Urgency~     Severity and Impact Questionnaire (USIQ).~      Hypothesis 1.1: The severity of urgency symptoms as measured by USIQ will change differently~     in women with OAB following a 3 month treatment with solifenacin succinate (10 mg OD) vs.~     fesoterodine (8mg OD).~      Hypothesis 2.1: Condition-specific quality of life (QOL) as measured by USIQ will change~     differently in women with OAB following a 3 month treatment with solifenacin succinate (10 mg~     OD) vs. fesoterodine (8mg OD).~      Objective 2: To advance the investigators understanding on the adverse events (AE's) of~     solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD).~      Hypothesis 1.1: The severity and rate of AE's in women with OAB following a 3 month of~     treatment with solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD) will be different.~   "
150609|NCT01595139|"~     MicroRNAs are small molecules which have recently been discovered in cells. They are known to~     be responsible for the normal development of cells and when they are disrupted can contribute~     to the development of cancer. Many previous studies have been done evaluating the expression~     of microRNAs in normal tissues as well as in a wide variety of cancers.~      Recently, microRNAs from tumor cells have been detected circulating in the blood of patients~     with cancer. This presents a novel opportunity to assess the utility of microRNAs in the~     blood as an early predictor of cancer as well as a marker of response to therapy. No previous~     studies have been performed evaluating microRNAs in archived tumor tissue and blood of~     patients with Neurofibromatosis type 1 (NF-1). The investigators propose a feasibility study~     to evaluate the presence of microRNAs in archived tumor tissue and the blood of patients with~     NF-1. If the investigators are able to identify circulating microRNAs in this population of~     pediatric patients, they will build upon this data in proposing a future study.~   "
150610|NCT01595126|"~     Biomarkers are small molecules that can be detected in the body fluids of patients; they~     often correlate with the presence of a cancer. MicroRNAs and proteins are small molecules~     which have recently been discovered in cells. They are known to be responsible for the normal~     development of cells and when they are disrupted can contribute to the development of cancer.~     Many previous studies have been done evaluating the expression of microRNAs and proteins in~     normal tissues as well as a wide variety of cancers.~      Recently, microRNAs and proteins from tumor cells have been detected circulating in the blood~     of patients with cancer. This presents a novel opportunity to use microRNAs and proteins in~     the blood as an early predictor of cancer as well as a marker of response to therapy.~     Previous work in our labs have identified miRNAs and proteins in the blood and cerebrospinal~     fluid (CSF) of pediatric patients with brain tumors.~      To determine a longitudinal evaluation of the presence of microRNAs and proteins in the~     blood, cerebrospinal fluid and urine of patients with central nervous system tumors from~     diagnosis through the course of their treatment. Though the duration of active treatment~     varies significantly based upon the diagnosis, patients will be followed for up to 24 months~     after enrollment onto the study).~   "
150611|NCT01595113|"~     The purpose of this study is to evaluate the safety of the previously conducted clinical~     trial cell transplant therapy using Hearticellgram-AMI for patients with acute myocardial~     infarction. This is a follow-up observational study and targeting the subjects who~     participated in the previously conducted clinical trial.~   "
151868|NCT01578525|"~     The purpose of this study is to determine whether additional pharmaceutical care for elderly~     patients (home-cared patients, nursing-home residents) has a positive impact on drug-related~     readmissions.~   "
150612|NCT01595100|"~     Childhood obesity is a major public health issue, and the identification of children who are~     at increased risk of health problems due to their obesity is a priority for modern health~     care. Abdominal fat is considered to be the most harmful in the body, and the development of~     reliable landmarks and procedures for the assessment of intra-abdominal visceral adipose~     tissue and total body fat in children will have a major impact on 1) the early identification~     of children at elevated health risk, 2) the proper prioritization of health care resources,~     and 3) the standardization of obesity surveillance procedures within and between countries.~   "
150613|NCT01595087|"~     This phase I/IIa study is a multi-center, prospective, open-label study evaluating safety and~     biological efficacy of up to six dose levels of Osteodex of patients with metastatic~     castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing~     three known substances; dextran, alendronate and guanidine.~      The objective of the study is to define the maximum tolerable dose of Osteodex when given~     every third week. The following objectives will also be evaluated: overall survival, PSA~     response, response markers related to bone metabolism (S-ALP and U-NTx), Quality of Life and~     assessment of pharmacokinetic parameters.~   "
150614|NCT01595074|"~     This research trial studies biomarkers in predicting treatment response in samples from~     patients with early-stage non-small cell lung cancer previously treated with adjuvant~     chemotherapy. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~   "
150615|NCT01595061|"~     This phase II trial studies how well radiation therapy works when given with gemcitabine~     hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva~     that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation~     therapy that delivers a high dose of radiation directly to the tumor may kill more tumor~     cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine~     hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more~     tumor cells.~   "
150616|NCT01595035|"~     Evidence indicates that postoperative pain after day surgery is inadequately controlled.~     Patients have different experiences and knowledge about how to deal with pain, and the need~     for information and clarification may vary. The aim of this study is to enhance pain~     management by academic detailing (patients' current knowledge and motivations are the basis~     for information) and nurse coaching (frequent and individualized support). The study consists~     of 4 phases; (1) a pilot study about patients experience with pain after surgery by a~     structured telephone interview; (2) development of an intervention to improve pain~     management; (3) implement and evaluate the intervention; (4) evaluate the incidence of~     chronic pain after day surgery. Even if patients are prescribed sufficient doses of~     analgesics, pain relief is dependent on patients' adherence with the analgesic regimen.~     Psychological factors, such as catastrophizing may also contribute to patients' experience of~     postoperative pain. Strategies that may be more effective than general information concerning~     surgery and pain management is academic detailing and nurse coaching, and will be used as~     frame for the intervention.~      Hypothesis:~      Over the seven days after surgery patients in the intervention group report;~        -  higher adherence with the analgesic regimen,~        -  have less pain intensity and pain interference with function and~        -  lower severity of side effects compared to the control group.~   "
150617|NCT01595022|"~     The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01~     and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and~     pain compared to a placebo T-frame intrauterine system.~   "
150618|NCT01595009|"~     To provide everolimus to patients with p-NET, GI or lung NETs before potential everolimus~     approval, the expanded access study CRAD001K24133 was designed to provide treatment until~     disease progression or unacceptable toxicity or until 30 May 2012, whichever occurs first. In~     this study, 60 patients with GI or lung NETs were enrolled in Germany and there are still~     approximately 40 patients benefiting from everolimus treatment.~      To provide the study medication to these patients beyond 30 May 2012, this open label~     extension will allow those patients who have been experiencing clinical benefit from~     everolimus treatment and who did not suffer from unacceptable toxicity to continue to receive~     treatment with the therapy until disease progression, unacceptable toxicity, or until study~     end on 31 May 2014, whichever comes first. Patients will be followed for safety and~     tolerability and for efficacy of everolimus.~   "
150619|NCT01594996|"~     The purpose of this retrospective observational study is to evaluate the characteristics of~     patients receiving Seroquel XR as treatment for their Major Depressive Disorder. The study~     will also investigate how the medication is used for these patients and if there are any~     differences in drug utilisation between the included countries. The study is observing~     patients initiating Seroquel XR during a 9 month period corresponding to 3 to 12 months~     following the launch of the product in each country for the MDD indication. A drug~     utilisation questionnaire will be used to collect study data from patients' medical records.~   "
150620|NCT01594983|"~     This study is to determine a dose response signal for LCQ908 monotherapy and to assess the~     efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.~   "
150621|NCT01594970|"~     This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with~     elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular~     hypertension (OH).~   "
150622|NCT01594957|"~     This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of~     hepatic impairment to healthy subjects.~   "
150623|NCT01594944|"~     The investigators will measure fetal orbital transverse and anterior-posterior diameter by 2D~     ultrasound and orbital volume by 3D ultrasound in women visiting our unit for other~     examinations during pregnancy. The investigators will examine 5-10 women in each gestational~     age in order to create a normal values curve throughout pregnancy.~   "
150664|NCT01594411|"~     This is a prospective, multi-center study examining the clinical impact of the Corus CAD~     (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no~     history of obstructive coronary artery disease who now present with chest pain or~     anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.~   "
150624|NCT01594931|"~     This is a double-blind, multicentre, randomised, parallel group, dose-finding study of the~     safety, tolerability and efficacy of a three day regimen of the combination of~     pyronaridine/artesunate in the ratio 3:1. The primary trial objective is to determine the~     clinical effective dose of orally administered pyronaridine/artesunate (3:1 weight/weight)~     ratio in the treatment of patients with acute uncomplicated P. falciparum malaria using the~     PCR-corrected adequate clinical and parasitological response (ACPR) at Day 28 as primary~     endpoint. Secondary trial objectives are to determine the safety of once daily dosing for~     three (3) days of pyronaridine+artesunate (3:1) combination in male and female patients with~     uncomplicated P. falciparum malaria and to explore possible ethnic differences in safety or~     efficacy in the two regions: South East Asia and Africa~   "
150625|NCT01594918|"~     The purpose of this study is to test the safety of cabazitaxel, mitoxantrone, and prednisone~     (CAMP) in combination at different dose levels and to determine the highest dose that does~     not cause bad side effects. The investigators want to find out what effects, good and/or bad,~     CAMP has on patients and their metastatic castration-resistant prostate cancer.~   "
150626|NCT01594905|"~     Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will show effective~     antiviral activity and prevent further development of antiviral resistance in hepatitis B e~     antigen(HBeAg)-positive or -negative Chronic Hepatitis B(CHB) patients who experienced~     multidrug resistance~      All subjects will orally take investigational drugs once daily for 48 weeks. All subjects~     will be assessed at baseline, Week 4, 12, 24, 36 and 48. Evaluations at each visit will~     include vital signs, physical examinations, laboratory tests and HBV DNA levels. They were~     also questioned about adverse events and concomitant medications. At baseline and every six~     months thereafter, serum will be assayed for HBV serology. Genotypic analysis will be~     performed at baseline and 48 weeks.~   "
150627|NCT01594892|"~     It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly~     improves pain relief compared to historic data of conventionally fractionated radiotherapy.~     Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain~     reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60~     patients will be included into this II trial.~   "
150628|NCT01594879|"~     A prospective multicenter trial has been started in Korea to investigate the treatment~     efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) plus Medroxyprogesterone~     Acetate(MPA) in Young Women with Early Stage Endometrial Cancer.~      The standard treatment for endometrial cancer is total hysterectomy and bilateral~     salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. However, young~     patients who desire to preserve their potential for fertility may find this standard~     treatment difficult to accept. Therefore, the conservative treatment for these patients has~     remained a challenge. A number of studies have reported the effectiveness of hormonal therapy~     using systemic progestin in women clinically diagnosed with early endometrial adenocarcinoma~     at stage IA, grade 1, who want to maintain reproductive potential. In addition, several~     recent studies reported the use of LNG-IUS to treat patients at a high risk of perioperative~     complications who cannot tolerate systemic progesterone because of its adverse effects.~     Nevertheless, there has been no prospective multicenter trial that investigated the~     effectiveness of treatment with systemic progesterone in combination with intrauterine~     progesterone in young women with endometrial cancer.~      Therefore, the investigators conducted a prospective trial of the treatment of the presumably~     early-stage grade 1 endometrial cancer in young women who desire to preserve fertility by~     using oral MPA in combination with LNG-IUS.~      Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is~     presumably confined to the endometrium, who desired to preserve fertility potential go~     through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently.~     Follow-up and treatment response assessment were implemented at a 3-month interval with~     office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage after~     removal of LNG-IUS.~      The primary endpoint is response rate. Secondary endpoint is to estimate the consistency of~     the results between office endometrial aspiration biopsy and dilatation and curettage (D&C)~     procedure.~   "
150629|NCT01594866|"~     The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and~     30 mg in patients with major depressive disorder.~   "
150630|NCT01594853|"~     The purpose is to see how X-linked adrenoleukodystrophy (X-ALD) is associated with strength~     and sensation using MRI, in women with X-ALD. The investigators will also see whether~     exercise can improve these symptoms for women with X-ALD.~   "
150631|NCT01594840|"~     This randomized trial has two sets of diapers-- a normal one and one that has tips for how to~     talk to and engage your toddler. The investigators are hoping that the intervention improves~     language development.~   "
150632|NCT01594827|"~     The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in~     Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that~     persistent infection with MRSA may result in an increased rate of decline in FEV1 and~     shortened survival. Currently there are no conclusive studies demonstrating an effective~     aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data~     demonstrating an effective and safe method of clearing persistent MRSA infection are needed.~      The purpose of this study is to evaluate the safety and efficacy of a 28-day course of~     vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in~     eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA~     infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250~     mg twice a day) or taste matched placebo and will be followed for 3 additional months. In~     addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or~     doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes.~     Forty patients with persistent respiratory tract MRSA infection will be enrolled in this~     trial.~   "
150633|NCT01594814|"~     Atrioventricular nodal reciprocating tachycardia (AVNRT) and atrioventricular reciprocating~     tachycardia (AVRT) are two similar supraventricular re-entry tachycardias (SVT) emerging in~     relatively young age in patients without apparent structural heart disease or significant~     comorbidities. The treatment of choice in those patients is radiofrequency ablation (RFA).~      The PPRA study is a prospective observational study developed to thoroughly analyze quality~     of life, utility and willingness-to-pay of Polish patients undergoing RF ablation of AVNRT or~     AVRT.~      Based on collected data the investigators will prepare a profile of patient who will benefit~     most from radiofrequency ablation and who should be scheduled in first place for the ablation~     in case of problems with accessibility to this service.~      What is more an analysis of medical and indirect costs of care will be performed.~   "
150634|NCT01594801|"~     This is the test protocol for the InsuPad device. The aim of the study is to show economical~     benefit when using the InsuPad device, by testing the effect of the InsuPad device on~     reducing injected insulin dose while keeping the same overall glycaemic control.~   "
150635|NCT01594788|"~     Observational study aimed to test the ability of Neutrophil Gelatinase-associated Lipocalin~     (NGAL) concentration in blood and urine to predict and diagnose early acute renal failure~     (ARF) in patients after cardiac surgery with/without Cardiopulmonary bypass (CPB).~   "
150638|NCT01594749|"~     This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3~     (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of~     fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and~     corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated~     with moderately emetogenic chemotherapy (MEC).~   "
150639|NCT01594736|"~     This prospective, randomized trial will compare the extent of covered stent strut segments by~     assessed by Optical Coherence Tomography (OCT) of the ORSIRO DES with that of the XIENCE~     PRIME DES, which is the standard of choice of contemporary drug eluting stents (DES).~   "
150640|NCT01594723|"~     The primary purpose of this study is to measure the response rate in participants with the~     myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET),~     or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an~     intolerance to, failure of primary response to, or have demonstrated disease progression~     while on ruxolitinib.~   "
150641|NCT01594710|"~     In Asia, the prevalence of metabolic syndrome have been dramatically increased. Therefore,~     the investigators intend to the collect the blood sample, laboratory, anthropometric, and~     body composition parameters prospectively to examine the risk factors of metabolic syndrome.~     Furthermore, the investigators will collect the data of carotid IMT and branchial ankle pulse~     wave velocity to clarify the metabolic risk factors of atherosclerosis.~   "
150642|NCT01594697|"~     The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of~     pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome~     (PCOS) women became pregnant during metformin treatment and continued taking the drug during~     gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were~     performed at each trimester of gestation.~   "
150643|NCT01594684|"~     In stent restenosis in peripheral artery disease (superficial and popliteal artery) either~     treated with uncoated or paclitaxel coated balloons.~   "
150644|NCT01594671|"~     Total knee arthroplasty is often associated with excessive postoperative bleeding due to~     increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to~     determine the peri-operative bleeding comparing the application of topical and intravenous~     tranexamic acid with the habitual surgical haemostasis.~   "
150645|NCT01594658|"~     The venous ulcer due to venous insufficiency causes an important morbility to those people~     suffering from this condition. Most of therapies available under the obligatory health plan~     (POS, acronym in spanish) to date cover the cleaning of the ulcerous lesion and its medical~     handling using saline solutions, topical antibiotics and elastic dressings, implying an~     important intake from health resources due to its chronicity and the delay in ulcers healing,~     which usually takes periods ranging from 6 months to several years. therapeutical~     alternatives, which can guarantee optimal, fast and persistent in time healings, should be~     identified.~      The aim of this study is to determine the percentage of healing of active venous ulcers~     (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6)~     following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with~     chronic venous ulceration after six months from the intervention, compared with conservative~     medical handling. The investigators expect that the ultrasound-guided foam sclerotherapy of~     superficial venous reflux will diminish the time of ulcer healing compared with standard~     handling.~   "
150646|NCT01594645|"~     Presently spermatozoa for ICSI are selected based on morphology and motion, without~     determining if acrosome reaction (AR) had occurred during sperm preparation or not. Although~     not critical if the sperm is injected into the ooplasm, the occurrence of AR might might be~     an indicator of better spermatozoon quality and implantation potential, especially in severe~     OTA cases. It is impossible with conventional plain optic microscopy used in IVF units to~     determine in vivo (without fixation) if AR has occurred, and as a result spermatozoa are~     injected randomly. It is readily possible to distinguish AR+ from AR- spermatozoa using~     polarized light microscopy due to different bifriengance.~      In this study the investigators seek to determine, by a prospective RCT, if selecting only~     acrosome reacted spermatozoa, in severe OTA cases, will improve the outcome of ICSI and the~     entire IVF process.~   "
150647|NCT01594632|"~     A study to assess the contraceptive effectiveness of Sino-implant (II).~   "
150648|NCT01594619|"~     Study in healthy volunteers to investigate the effects of Diltiazem on the Pharmacokinetics~     of naloxegol.~   "
150649|NCT01594606|"~     The project involves testing the efficacy of an animal-assisted intervention (AAI). The AAI~     consists of a 10-week program in which adjudicated adolescents train shelter dogs and will be~     compared to a dog walking control group matched for educational content and dog contact time.~     The investigators expect that the AAI will result in improved empathy skills and that dog~     attachment will explain these findings. The investigators also explore the extent to which~     the AAI will improve internalizing and externalizing symptoms in these adolescents.~   "
150650|NCT01594593|"~     Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause~     of death in American men. Those diagnosed with localized prostate cancer encounter three~     sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3)~     the often life-altering side effects of treatment. In addition, patients who choose to~     undergo active surveillance which focuses on monitoring cancer in lieu of treatment,~     experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is~     an established psychosocial intervention that has been used extensively for mental health~     treatment and has shown benefits for various chronic conditions. ACT is a behavioral~     intervention that focuses on tolerating distress and improving function. This pilot study is~     designed to test the feasibility of ACT for distress reduction and improved quality of life~     in patients recently diagnosed with early-stage, localized PCa.~   "
150651|NCT01594580|"~     This study will test if nurses wearing scrubs treated with an antimicrobial agent while~     performing patient care will:~      - Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital~     shift during routine use after home laundering~      This study will gather information by obtaining swabs from scrubs treated with an~     antimicrobial and from non-treated scrubs.~   "
150830|NCT01592240|"~     To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615~     administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with~     high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a statin.~   "
150652|NCT01594567|"~     Dietary pulses, more commonly known as legumes, are generally recognized as healthy~     components of the diet. Canada's Food Guide encourages consumptions of meat alternatives,~     such as beans more often; and the dietary guidelines for Americans both recommend~     consumption of 3 cups of legumes per week. However, there still remain insufficient~     information on the usefulness of these foods in protecting heart health. To improve~     evidence-based guidance for non-oil-seed pulse recommendations, the investigators propose to~     conduct a systematic review of clinical studies to assess the effect of eating pulses in~     exchange for other foods on measures of heart disease risk and blood sugar control in humans.~     The systematic review process allows the combining of the results from many small studies in~     order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The~     investigators will be able to explore whether eating pulses has different effects between men~     and women, in different age groups, in people with high or normal sugar or blood fat levels,~     and whether or not the effect of pulses depends on how much/often they are eaten. The~     findings of this proposed knowledge synthesis will help improve the health of Canadians~     through informing recommendations for the general public, as well as those at risk of heart~     disease and diabetes.~   "
150653|NCT01594554|"~     A 5-year study to observe and describe long-term patient management and treatment patterns~     with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the~     CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their~     genotype characterized at diagnosis of HCV infection in a real world clinical practice in~     China.~   "
150654|NCT01594541|"~     This retrospective analysis of de-identified data from 700 charts of consecutive patients~     from this patient population is to investigate the prevalence of hyperhomocysteinemia and~     associated metabolic abnormalities in this naturalistic grouping of patients with various~     stages of cognitive loss and diagnosed with various types of dementia.~   "
150655|NCT01594528|"~     Numerous factors can influence the processing of pain message: the affective or emotional,~     the sensorial and the cognitive components. Interindividual variations at the emotional and~     cognitive levels may interfere with the pain message and the consecutive behavior. Some~     modifications in these components are observed in psychiatric troubles, but their influences~     on the behavior to pain have not been studied, although they have been studied in some~     populations characterized as non communicating, with obvious cognitive degradations (subject~     with dementia, older, newborns,…).In an other study in course, the past pain experience is~     explored in relation to results to experimental pain tests, emotional and anxious~     characteristics. This present pilot study aims at studying the infra-verbal behavioural signs~     during experimentally induced pain in subjects with schizophrenia, major depression, and~     controls.~   "
150656|NCT01594515|"~     In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected~     pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.~   "
150657|NCT01594502|"~     The goal of this study is to apply cutting-edge imaging approaches, incorporating~     machine-learning for pattern recognition and multispectral analysis, to the development and~     validation of intermediate endpoint biomarkers in benign tissue that characterize the~     response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer~     among men with negative biopsies.~   "
150658|NCT01594489|"~     The purpose of this study is to determine whether additional therapy with Aminophylline to~     hydration with sodium bicarbonate and administration of N-acetylcysteine is more effective to~     prevent contrast induced acute kidney injury in patients undergoing primary coronary~     intervention for acute ST elevation myocardial infarction.~   "
150659|NCT01594476|"~     Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead~     to negative consequences during the subsequent pregnancy. Providers have traditionally~     delayed starting birth control, especially placement of intrauterine devices (IUDs),~     post-delivery for a number of reasons. The first postpartum visit after a woman has given~     birth is typically scheduled for 6 weeks after her delivery, during which she is typically~     provided with her chosen method of birth control. This study will evaluate two different IUD~     placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to~     determine if placement time affects a woman's follow-through obtaining the IUD and keeping it~     inserted in place. The researchers will also look at bleeding patterns and patient/provider~     satisfaction with the IUD placement~   "
150660|NCT01594463|"~     Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of~     40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be~     associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and~     hospitalization in intensive care unit. The investigators hypothesis that a later third~     trimester routine ultrasound may be more accurate to diagnose late intrauterine growth~     restriction.~   "
150661|NCT01594450|"~     The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single~     blinded trial comparing the use of biological mesh versus traditional wound care without~     biological mesh in patients with an infected incisional ventral hernia. The primary endpoint~     is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at~     45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain,~     quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh~     structure, and medico-economic evaluation. One hundred patients need to be included.~   "
150662|NCT01594437|"~     The purpose of this study is to compare the safety profile in healthy adult volunteers of~     single or multiple intravenous administrations of TCN-202 as compared with placebo.~   "
150663|NCT01594424|"~     In this Phase I/II trial, 10 highly sensitized patients will be entered after informed~     consent and will receive Intravenous Immunoglobulin (IVIG) at 2 gm/kg + Tocilizumab 8 mg/kg x~     5 doses on days 15, 45, 75, 105, 119, 135, and 149. If robust reductions in anti-HLA antibody~     are seen, patients will progress to kidney transplantation when an acceptable crossmatch is~     achieved with a living donor (LD) or deceased donor (DD). Those receiving transplants will~     also receive Tocilizumab infusion monthly X7 doses post-transplant. All subjects will have~     intensive monitoring of Donor Specific Antibodies (DSA), viral PCRs, and routine~     post-transplant labs. At 6 months post-transplant, those who have retained their transplanted~     kidney will have a protocol biopsy.~   "
150831|NCT01592227|"~     A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an~     adjuvant from two different paracetamol formulations.~   "
150665|NCT01594398|"~     The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of~     the experimental drug, entinostat, in women with breast cancer and men and women with~     non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated~     when entinostat is given by itself as well as with the approved drugs, exemestane (Aromasin®)~     or erlotinib (Tarceva®). A biomarker (chemical marker in the blood/tissue that may be~     related to your response to the study drug) will also be tested.~   "
150666|NCT01594385|"~     The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who~     are undergoing open abdomen damage control management for traumatic injuries when compared to~     no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm~     adhesion barrier on:~        -  the number and intensity of adhesions,~        -  whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm)~          who go on to successful definitive abdominal closure,~        -  rate of occurrence of secondary complications (such as abscesses) associated with short-~          and long-term beneficial effects of reducing adhesion formation,and~        -  whether there is any difference between treatment groups regarding patient functional~          recovery.~   "
150667|NCT01594372|"~     Investigators intend to conduct a prospective randomized trial to compare vaginal~     hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with~     sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for~     uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have~     not been compared directly. The investigators hypothesize that there is no difference in~     objective, subjective, or cost-effectiveness between the two procedures for up to two years~     after surgery.~   "
150668|NCT01594359|"~     The purpose of this study is to determine whether beans bred to have a high iron content are~     effective in improving the iron status of young women.~   "
150669|NCT01594346|"~     The purpose of this study is to determine the safety and effectiveness of 2,000 international~     units of Vitamin E (alpha tocopherol)on cognitive function of aging persons with Down~     syndrome. It is a randomized, double-blind, placebo-controlled trial lasting 36 months. It is~     expected that Vitamin E will slow the deterioration in cognitive functions associated with~     Alzheimer disease.~   "
150670|NCT01594333|"~     The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial~     investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death~     in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple~     coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute~     (NHLBI)/National Institutes of Health (NIH).~   "
150671|NCT01594320|"~     The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian~     flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down~     into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test~     article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment~     following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts~     of the study.~   "
150672|NCT01594307|"~     The purpose of this study is to monitor the blood pressure level of the patient using a~     preformed cuff ranged 13.5 cm-22 cm.~   "
150673|NCT01594294|"~     The purpose of this study was to assess and compare the effect of the repeated usage of 2~     different care systems (one hydrogen peroxide based cleaning and disinfecting system and one~     PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn~     on a daily wear basis for a 3-month period.~   "
150674|NCT01594281|"~     This study will assess the efficacy and safety of Ranibizumab alone or in combination with~     laser treatment vs. laser treatment alone in Proliferative Diabetic Retinopathy. Efficacy~     will be primarily measured by the change of area of neovascularizations as measured by~     Fluorescein Angiography at month 12 (difference to baseline value).~   "
150675|NCT01594268|"~     A prospective, open label study of CERtican in KIdney transplantation~   "
150676|NCT01594255|"~     This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the~     QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.~   "
150677|NCT01594242|"~     The purpose of this study is to better understand the effects of the chemotherapy medication~     bortezomib on cancer cells. The investigators are therefore taking blood and bone marrow~     samples from patients with myeloma who are receiving bortezomib to see if the investigators~     can detect autophagy in the myeloma cells from the bone marrow and in immune cells in the~     blood. Subjects are eligible if their doctor is planning to treat them with bortezomib for~     the first time for their myeloma.~   "
150678|NCT01594229|"~     This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic~     profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in~     approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study will~     evaluate the safety and pharmacokinetic profile of ABT-199 in approximately 60 subjects when~     administered in combination with Bendamustine/Rituximab following a dose escalation scheme,~     with the objective of defining the dose limiting toxicity and the maximum tolerated dose.~   "
150679|NCT01594216|"~     This is a Phase II investigator-Initiated trial of the Investigational Drug, Ruxolitinib, in~     combination with Exemestane in patients with estrogen-receptor positive advanced breast~     cancer. The objective of this study is to determine the preliminary safety and efficacy of~     the combination of exemestane and Ruxolitinib (INCB018424).~   "
150680|NCT01594203|"~     Soft Tissue Sarcoma (STS) is a rare tumor but can grow in different areas, for example, in~     60% in limbs and about 20 % in retroperitoneum; and frequently is inoperable. Despite novel~     therapy in advanced cases survival is still short, approximately 12 month.~      Pazopanib oral angiogenesis inhibitor was recently shown as promising drug for advanced~     pretreated STS.~      Functional imaging especially F18-FDG PET/CT is a good modality for FDG avid tumor either for~     pre- / post- treatment evaluation or follow up.~      Early detection of treatment response to therapy by whole body FDG PET/CT allows for change~     of treatment as early as possible,when the tumor is non-responsive before serious side~     effects appear or before depletion of body resources.~      The aim of the study is to investigate the contribution of FDG PET/CT to assessment of~     treatment response.~   "
151869|NCT01578512|"~     The purpose of this study is to determine the best format for delivering a brief behavioral~     weight loss intervention to young adults 18-25 years of age.~   "
150681|NCT01594190|"~     Stroke is the leading cause of adult disability in Europe and United States and the second~     leading cause of death worldwide and affects more than 10,000 Danes each year.~      Studies in a late and stationary phase after stroke have shown that physical rehabilitation~     is of great importance for survival and physical ability of these patients, however many~     studies show that patients lie or sit next to their bed under hospitalization for more than~     88.5 % of the daily hours. Physical activity in stroke patients has never previously been~     measured immediately after debut of symptoms; furthermore there is no knowledge about the~     optimal dose of physical rehabilitation for these patients.~      Accelerometers, small measuring devices, are a relatively new way to measure physical~     activity precisely, and hence it is possible to obtain an objective measure of how active~     stroke patients are in the first week after admission. The accelerometers measure a variable~     voltage, depending on the range and intensity of movement. They can measure movement~     dependent of the placement of the accelerometer, for instance over the hip, arm or leg.~     Studies confirm their reliability, even in patients with abnormal gait, such as stroke~     patients.~      Another approach of studying the effects of physical activity and rehabilitation is through~     the examination of biomarkers. Studies have shown that biomarkers released during physical~     activity can inhibit biomarkers released after tissue injury in the brain, as seen after~     stroke. These brain biomarkers cause further damage and studies show that the higher the~     levels, the higher the damage. It is therefore obvious to examine whether physical activity~     rehabilitation can down regulate this destructive process in patients with stroke.~      Clarification of the optimal dose of physical activity in stroke patients immediately after~     debut of symptoms and examination of both the biochemical aspects of physical rehabilitation~     as well as the optimal dose of physical rehabilitation is of great importance for many~     patients, their relatives as well as of a great socioeconomic importance.~      The purpose of the project is to investigate which dose (15 vs. 2 x 30 minutes) of physical~     activity on a weight-bearing treadmill in the first 5 days after admission after an ischemic~     stroke, gives patients the best improvement in neurological dysfunction.~   "
150682|NCT01594177|"~     Anthracycline/taxane based combination chemotherapy of at least 18 weeks represents the~     standard of care in the neoadjuvant setting. In HER2 positive disease trastuzumab is given~     simultaneously. Neoadjuvant anthracycline-taxane-based chemotherapy given simul-taneously~     with trastuzumab achieves a pCR rate of approx. 40%. Recent data showed that a double~     blockade of the HER2 receptor (e.g. trastuzumab + lapatinib; trastuzumab + pertuzumab) given~     together with a few cycles of chemotherapy can increase the pCR rate by approximately 20%. So~     far, there is uncertainty, if afatinib (BIBW 2992), an irreversible HER family blocker can~     lead to an even more complete blockade of the HER2 pathway when given in combination with~     trastuzumab. The neoadjuvant setting provides the unique opportunity to assess precisely and~     at short term the effect of systemic treatment by assessing the pCR at surgery. It also~     allows treating patients with HER2 positive breast cancer before surgery without standard~     trastuzumab treatment, as, according to current guideline, trastuzumab can also be given~     sequentially after surgery. The aim of the study is to show that chemotherapy + trastuzumab +~     afatinib can achieve significant pCR rates.~   "
150683|NCT01594164|"~     In this study the changes in upper airway geometry and resistance between images, obtained in~     upright and supine position, will be evaluated. Therefore a Cone Beam Computed Tomography~     (CBCT) scan and a low dose Computed Tomography (CT) scan will be taken in a population of 20~     subjects. The upright morphology will be obtained using CBCT scan while the supine upper~     airway geometry will be determined using a standard High Resolution Computed Tomography~     (HRCT) scanner.~   "
150684|NCT01594151|"~     Asthma in children is recognized as a disease area with a high medical need. As the~     investigators move into this field it is necessary to improve the investigators knowledge of~     upper airway anatomical structure in paediatric patients. This study will provide~     airway/facial morphologies from controlled asthmatic patients. Limited facial morphology can~     be used in order to build models to study the delivery of medication through a device that~     requires for example a facemask. In this study the anatomical structure of the upper airway~     and the facial geometry will be evaluated using a Cone Beam Computed Tomography (CBCT) scan.~     The scan will be taken in a population of 20 asthmatic children between 6 and 12 years old.~   "
150685|NCT01594138|"~     The purpose of this study is to determine whether patients who have a high risk for serious~     suicide behavior will demonstrate a speech pattern that has a relationship to language~     patterns found in suicide notes.~   "
150686|NCT01594125|"~     The aim of the study is to investigate the safety, tolerability, efficacy and~     pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to~     curative surgery or loco regional therapy~   "
150687|NCT01594112|"~     The purpose of the THORN registry is to show the ability of Home-Monitoring® to early~     identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients~     (i.e. lead rupture, atrial arrhythmia, oversensing…) whatever the type of device (single,~     dual, or triple chamber).~      The electromyograms (iEGMs) provided by Remote Patient Monitoring will help the physician to~     early detect inadequate arrhythmia detection (ID) that can be responsible for inappropriate~     therapies (IT), and to take preventive actions in order to reduce the burden of these~     inappropriate therapies.~      THORN is an observational epidemiologic, prospective and multicenter registry. The primary~     objective is to measure the relative proportion of patients experiencing at least one~     inappropriate therapy during a fifteen months follow-up period. Moreover, THORN will assess~     the incidence, predictors, outcome and recurrence of inappropriate diagnoses in 1750 ICD~     patients.~   "
150688|NCT01594099|"~     The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin~     /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced~     cervical cancer in elderly women.~   "
150689|NCT01594086|"~     Green tea contains catechins and theanine as major ingredients and has been reported to have~     various beneficial influences on human health. It is reported that the drinking green tea is~     inversely associated with serum homocysteine level in elderly. However the effect of green~     tea consumption on cognitive dysfunction is not clinically clarified. The purpose of this~     study is to investigate the effects of green tea consumption on homocysteine metabolism and~     cognitive dysfunction in elderly with impaired cognitive function.~   "
150690|NCT01594073|"~     Implantable cardioverter-defibrillator (ICD) therapy reduces mortality in patients with~     chronic heart failure and reduced left ventricular ejection fraction (LVEF) <36%.~     Nevertheless, patient selection for ICD therapy based on LVEF and NYHA functional class alone~     seems to have a low specificity and sensitivity: In 100 patients treated, the SCD-HeFT study~     prevented 7 deaths in 5 years. Therefore 93 patients have a risk of adverse effects, such as~     operation risk, infection, pneumothorax, lead dislocation, and inadequate icd therapy. On the~     other hand, patients with advanced or end stage heart failure might rather die off~     progressive heart failure death and thus not benefit from ICD therapy.~      It therefore seems appropriate and necessary to improve the individualized risk~     stratification in these patients. The aim of this study is to evaluate multiple cardiac~     biomarkers in a model predicting ventricular arrhythmias in patients on ICD therapy.~   "
151880|NCT01578369|"~     To investigate the effect of pelvic floor muscle training taught in a general exercise class~     during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.~   "
150691|NCT01594060|"~     A comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized~     in the medical department. The first approach is called basal-bolus in which 4 insulin shots~     are given daily ( 3 short acting before meals and one long acting before bed time). The~     second approach is called sliding scale in which short acting insulin alone is given before~     meals and before bed time according to the patient's glucose values. The aim is to keep~     fasting glucose between 140-180 mg/dl.~   "
150692|NCT01594047|"~     Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents~     opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal~     surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a~     N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative~     Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia~     after abdominal surgery.~   "
150693|NCT01594034|"~     Our objective is to determine whether or not the presence of hemoperitoneum in trauma~     patients is associated with increased Carbon Monoxide (CO) formation, and to determine if~     elevated Carbon Monoxide levels are associated with cardiovascular depression, impaired~     platelet aggregation, and/or multiple organ failure.~   "
150694|NCT01594021|"~     Induction of general anesthesia induces frequently arterial hypotension. The short term goal~     of this study is to evaluate if preemptive volume loading prevents such complication.~   "
150695|NCT01594008|"~     The goal of the study is to find out whether a high fat meal increases blood lipids and~     causes monocyte (white blood cell) activation, and whether blueberry intake at the same meal~     lessens monocyte activation in healthy people.~   "
150696|NCT01593995|"~     Epidermal growth factor receptor-tyrosin kinase inhibitor (EGFR-TKI, Erlotinib) has~     demonstrated its efficacy in patients with non-small cell lung cancer and pancreatic cancer.~     But, their use is associated with dermatologic reactions of varying severity. Incidence of~     Erlotinib related skin effect (ERSE) was reported ~75% in NSCLC and pancreatic cancer phase~     III trials. Even though the dermatologic reactions could be a surrogated marker, it may be~     cause of dose modification. Also, it could give significant physical and psycho-social~     discomfort to patients. However, there is still a wide variety of drugs used- including,~     steroid, antibiotics, and vitamin D without any clear evidence based management~     recommendation.~      The role of epidermal growth factor (EGF) has been extensively investigated in normal and~     pathological wound healing. It is implicated in keratinocyte migration, fibroblast function~     and the formation of granulation tissue. The first growth factor to be isolated growth factor~     therapy has progressed into clinical practice in the treatment of wounds.~      Therefore, the investigators propose an epidermal growth factor ointment apply for patients~     with Erlotinib related skin effects.~   "
150697|NCT01593982|"~     Even in the absence of a preliminary diagnosis of Attention Deficit Hyperactivity Disorder,~     symptoms of attention deficit, hyperactivity and cognitive impairment are common in cocaine~     addicts.~      Several factors indicate that repetitive transcranial magnetic stimulation might be a~     strategy to aid in the treatment of symptoms of attention deficit hyperactivity disorder and~     cognitive function in cocaine addicts.~      However, up to current days there have been no studies evaluating the effects of Repetitive~     Transcranial Magnetic Stimulation (rTMS) on neurocognitive performance of individuals~     suffering from the ADHD.~   "
150698|NCT01593969|"~     The investigators will perform a randomised controlled trial of the provision of food~     designed for rehabilitation of malnourished children that is supplemented with n-3 fatty~     acids compared to usual composition. The investigators want to see whether the provision of~     such a food normalises the deficiencies in essential fatty acids observed in severely~     malnourished children faster than standard composition.~   "
150699|NCT01593956|"~     Concussed athlethes have discrete decreased abilities in motor learning. Recent research~     could further show, that cortical plasticity, as measured by transcranial magnetic~     stimulation (TMS) is reduced. This is possibly due to an increased GABAergic activity, what~     have been found in concussed athletes by paired pulse protocols in TMS.~      GABAergic acitivty can be modulated by transcranial direct current stimulation (tDCS) in a~     polar-specific manner: anodal tDCS was able to decrease GABA, whereas cathodal tDCS increased~     tDCS.~      Our study aimes to assess the influence of anodal tDCS on cortical plsticity in concussed~     athlethes. We hypothesize, that anodal tDCS is able to increase cortical plsticity in~     concussed athlethes.~   "
150700|NCT01593943|"~     The major barrier to India meeting its national goal of replacement fertility is the huge~     discrepancy between urban and rural family planning, with rural young women at highest risk~     for unplanned and unspaced pregnancies. These concerns are considered to drive the persistent~     and unacceptably high rates of maternal and infant mortality in India. Major impediments to~     these young wives' acquisition of family planning services include high male partner control~     over reproductive decision-making, low mobility, and very low access to family planning~     services in villages. Such findings document the need for male-centered family planning~     efforts available at the village level, to better meet the needs of rural young wives. These~     male-centered efforts must address male gender role and gender inequity ideologies and norms~     (e.g., son preference, wife abuse) and marital communication, as these factors are associated~     with lower likelihood of contraceptive use in rural young Indian couples. Hence, the proposed~     study involves development and testing of the CHARM Program, a gender equity (GE)-focused,~     male-centered family planning (FP) program delivered by village health providers (VHPs), via~     a public-private partnership with primary health centers (PHCs) and private providers serving~     rural India. In Phase 1 the investigators will conduct formative research including health~     care resource mapping of Vasai within the Thane district of Maharashtra to identify villages~     and VHPs for inclusion in subsequent research and intervention. The investigators will also~     conduct in-depth interviews with rural young husbands (n=30), rural young wives (n=20), and~     health care providers (n=12), as well as focus groups with mothers' of rural young husbands~     (n=40). These data will be used to develop the CHARM program and efficacy trial. Phase 2 will~     involve development and pilot testing of CHARM protocols and training of VHPs for their role~     in the intervention trial (Phase 3). The CHARM intervention will involve VHP-delivered GE and~     FP counseling. It is delivered via a single session with 2 optional additional sessions one~     of which would include their wife. Phase 3 will involve evaluation of CHARM, using a~     two-armed randomized controlled trial design. Villages (N=50) will be randomized to receive~     either CHARM or the control program (standard FP referral to government public health centers~     [PHCs] located outside of villages), to assess treatment impact on spacing contraceptive use,~     pregnancy, and unmet family planning need. Intervention effects will be assessed via~     behavioral surveys with rural young husbands (18-30 years) and their wives (N=1000 couples,~     20 couples per village) at baseline and 9 and 18 month follow-up, as well as pregnancy tests~     from wives, conducted at baseline and 18 month follow-up. A process evaluation will be~     undertaken via interviews with study participants and VHPs, as well as through VHP interviews~     and clinical record review, to assess program adherence, participation rates, response to~     program, and ease of delivery. In-depth interviews will also be conducted with key informants~     from the village and public and rural health systems to assess sustainability and~     institutionalization of the model.~   "
150701|NCT01593930|"~     The purpose of this study is to determine the success rate of pulpal anesthesia in mandibular~     firs molar following infiltration of 4% articaine alone and as supplemental injection after~     inferior alveolar nerve block(IANB).~   "
150702|NCT01593917|"~     To collect long term follow up study data of the Trifecta valve in subjects who had the~     Trifecta valve implanted during the IDE study.~   "
150703|NCT01593904|"~     1. What is the true incidence of CCSVI in patients with MS in a study comparing MRI on MS~          patients and controls.~        2. Are the beneficial outcomes from treatment placebo? By measuring changes in brain~          perfusion and Cerebrospinal flow before and after the procedure on a large number of~          patients to determine these outcomes~   "
150704|NCT01593891|"~     Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic~     Cerebral Spinal Venous Insufficiency Treatment~   "
150705|NCT01593878|"~     This study aims to test whether middle school students test performance is affected by~     background TV. Students will complete a high school entrance exam either with or without a TV~     on in the test room. Scores will be compared.~   "
150706|NCT01593865|"~     The present study hypothesizes that the systematic use of bilateral internal mammary artery~     (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for~     the treatment of multivessel coronary artery disease (primary hypothesis). The secondary~     study hypothesis is that the BIMA grafting meets the safety endpoint compared with the~     conventional surgical strategy entailing left mammary artery grafting plus great saphenous~     vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis is~     that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms~     related to coronary disease, of repeat revascularization and of cardiac mortality compared~     with patients treated with the conventional surgical strategy entailing left mammary artery~     grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.~   "
150707|NCT01593852|"~     Allura Clarity is a novel X-ray imaging technology, that combines advanced real-time image~     noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose~     significantly. This is realized by anatomy-specific optimization of the full acquisition~     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing~     engine) for every clinical task individually. Furthermore, smaller focal spot sizes and~     shorter pulses are used, which are known to positively influence image quality .~      The primary aim of this study is to verify if a significant reduction in total procedural~     X-ray dose during electrophysiological interventions can be achieved by using advanced image~     processing (Allura Clarity).~   "
150708|NCT01593839|"~     The main objective of this study is to investigate the muscle metabolism in individuals with~     chronic non-specific low back pain (CNSLBP) to enhance our understanding of chronic back~     pain.~   "
150709|NCT01593826|"~     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with~     the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.~   "
150710|NCT01593813|"~     The theoretical benefits of the repair of the pronator quadratus include flexor tendon~     protection, remain of the normal pronation-supination range of motion (ROM) and strength, and~     keeping the stable DRUJ.~      Repair or not repair pronator quadratus in the volar plating of distal radial fracture-Are~     functional outcomes differ?~   "
150711|NCT01593800|"~     Lactose intolerance (LI), also known as lactose malabsorption is the most common type of~     carbohydrate malabsorption. It is associated with the inability to digest lactose into its~     constituents, glucose and galactose, due to low levels of lactase enzyme activity (1-2). At~     birth, lactase activity is at the highest and it declines after weaning (1-2). The unabsorbed~     lactose is metabolized by colonic bacteria to produce gas (hydrogen (H2) and methane (CH4))~     and short chain fatty acids. Symptoms related to LI appear 30 minutes to 2 hours after~     consumption of food products containing lactose. Related symptoms include: bloating,~     cramping, flatulence and loose stool (1-2, 17-18).~      Highest rates of LI are found in the Asian populations, Native Americans and African~     Americans (60-100%), while lowest rates are found in people of northern European origin~     (including northern Americans) (3-4).~      The diagnosis of LI based on patients' symptoms is sometimes problematic, since these~     symptoms are not specific and may differ from one patient to another. Breath hydrogen test~     have been advocated as the best diagnostic tool for the assessment of LI (15-16). During the~     test, subjects are sampled for hydrogen levels of breath samples at base line and every 30~     minutes after the administration of 50 grams of oral lactose, for a total period of 180~     minutes. A breath sample with > 20 ppm above baseline is considered positive for LI (15-16).~      There are no established treatments for LI, other than almost complete avoidance of lactose~     rich dairy products. Avoidance of dairy products is a major concern since its outcome may~     result in a dietary calcium intake that is well below recommended dose of 1,000 mg per day~     for men and women and 1,300 mg for adolescents (8-10). For this reason different course of~     action needs to be considered instead of a complete exclusion of dairy products by LI~     patients.~      Two possible interventions in the case of LI are the supplement of commercially available~     lactase (tablets) or the addition of probiotics.~      The consumption of lactase enzyme as a food supplement may assist in restoring adequate~     levels of the enzyme needed for hydrolysis of lactose, especially for patients with low, or~     non existent levels of lactase. On the other hand, lactase products are problematic since not~     all lactase preparations are of the same concentration. Moreover, it is difficult to asses~     the amount of lactase tablets needed in order do fully hydrolyze lactose in each dairy mill~     (14).~      Probiotics are live microorganisms that are commonly used in order to prevent or treat a~     disease. The current definition by the Food and Drug Administration and the World Health~     Organization is Live microorganisms which, when administered in adequate amounts, confer a~     health benefit on the host. These microorganisms are a heterogeneous group, they are~     nonpathogenic and produce beta- galactosidase or lactase intracellularly that may assist in~     the digestion of lactose (11).~      Studies have shown that people with lactose intolerance tolerated the lactose in yogurt~     better than the same amount of lactose in milk. The assumption was that the presence of~     lactase producing bacteria in the yogurt, especially Lactobacillus acidophilus, contributed~     to the digestion and absorption of lactose (5-6, 13).~      It was also found that the presence of Lactobacillus bulgaricus and Streptococcus~     thermophilus alleviate lactose intolerance through their ability to produce lactase enzyme~     (7).~      Finally, in another study it was found that consumption of milk containing Bifidobacterium~     longum resulted in significantly less hydrogen production and flatulence as compared to the~     consumption of control pasteurized milk (12).~      Based on the mentioned data, the investigators speculate that the administration of~     probiotics may assist with the consumption of dairy products containing lactose. Therefore,~     the aim of this study is to evaluate the effect of probiotics on patients with LI.~   "
150712|NCT01593787|"~     This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients~     with renal dysfunction.~   "
150713|NCT01593774|"~     The purpose of this study is to determine whether melatonin can prevent metabolic side~     effects of olanzapine such as weight gain, elevated glucose concentrations and lipid~     abnormalities.~   "
150714|NCT01593761|"~     Primary Objective:~      To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with~     cABSSSI (major cutaneous abscesses) due to MRSA.~      Secondary Objective(s):~        -  To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due~          to MRSA~        -  To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.~        -  To assess the safety of multiple doses of CG400459~   "
150715|NCT01593748|"~     This study is for adult subjects with advanced tissue sarcoma. The study involves the drugs~     Pazopanib (Votrient), Gemcitabine (Gemzar), and Docetaxel (Taxotere). The purpose of this~     study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with~     Gemcitabine and Docetaxel in participants with soft tissue sarcoma.~   "
150716|NCT01593735|"~     This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts.~     Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II~     will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or~     may be staggered.~   "
150717|NCT01593722|"~     Background:~        -  Loa loa is a small worm that infects people in West and Central Africa. It is spread by~          the bite of a fly. Adult worms live under the skin and can cause swelling in the arms,~          legs, and face. Some people have more serious infections in the heart, kidneys, or~          brain. Most people with Loa loa infection have no symptoms at all. The standard~          treatment for Loa loa infection is a medicine called diethylcarbamazine (DEC). Some~          people have bad reactions to DEC, including itching, muscle pains, and in severe cases~          coma and death.~        -  Another drug, ivermectin, is used in mass drug treatment programs to prevent the spread~          of worm infections that cause blindness and massive swelling (elephantiasis). However,~          people who also have Loa loa have had serious bad reactions to ivermectin. Researchers~          want to study both DEC and ivermectin to find out why these reactions occur. If they can~          be prevented, mass drug treatment programs will be able to be used in areas in Africa~          where Loa loa exists.~      Objectives:~      - To study the side effects of DEC and ivermectin treatment for Loa loa infection.~      Eligibility:~      - Individuals who live in 4 villages in Cameroon where Loa loa infection is known to exist,~     who are between 20 and 60 years of age, not pregnant or breastfeeding and have a low level of~     Loa loa parasites in the blood, but are otherwise healthy.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected to check for Loa loa infection. Participants will also have an eye~          exam and provide skin samples to check for other worm infections that may interfere with~          the study treatment.~        -  Participants will be admitted to the hospital for 4 days (during and after the~          treatment). They will receive a single dose of either DEC or ivermectin.~        -  After treatment, regular blood samples will be collected. Participants will be asked~          questions about how they feel after treatment. Physical exams will be performed. If side~          effects develop, participants will be treated at the hospital.~        -  After leaving the hospital, participants will have followup visits. These visits will~          happen on days 5, 7, 9, and 14 after receiving the study medicine. They will involve a~          short physical exam and collection of blood samples.~        -  At the end of the study, participants will be offered a full 21-day DEC treatment to~          cure the Loa loa infection.~   "
150718|NCT01593709|"~     Background:~      - Vaccines and antiviral therapies are critical for preventing and treating viral diseases.~     Testing these vaccines and drugs often requires healthy volunteers. To ensure that volunteers~     are healthy and eligible to participate in these studies, they will be screened before the~     start of the study. This screening may involve a medical history, physical exam, and blood~     test. Other samples may also be collected. This study will help identify volunteers who are~     eligible to participate in vaccine or antiviral therapy trials.~      Objectives:~      - To screen volunteers for clinical trials of vaccines or drugs to treat or prevent virus~     infections.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Screening may begin several months before the start of the clinical trial. Participants~          may come to the National Institutes of Health clinic one or more times.~        -  Participants may be screened with a physical exam and medical history. Blood samples~          will be collected. Other samples may also be collected, including urine, nasal wash,~          nasal swab, or stool samples. All samples will be stored for reference by the study~          researchers.~   "
150719|NCT01593696|"~     Background:~      - Although progress has been made in treating children with B-cell cancers such as leukemia~     or lymphoma, many children do not respond to the standard treatments. One possible treatment~     involves collecting white blood cells called T cells from the person with cancer and~     modifying the cells to attack the B-cell cancer. The cells can then be given back to the~     participant. This study will use T cells that have been modified to attack the CD19 protein,~     which is found on the surface of some B-cell cancers.~      Objectives:~      - To see if anti-CD19 modified white blood cells are a safe and effective treatment for~     children and young adults with advanced B-cell cancer.~      Eligibility:~        -  Children and young adults between 1 and 30 years of age who have B-cell cancer (leukemia~          or lymphoma) that has not responded to standard treatments.~        -  The leukemia or the lymphoma must have the CD19 protein.~        -  There must be adequate organ function.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies or bone marrow biopsies may be performed~          depending on the type of cancer.~        -  Participants will undergo a process where white blood cells are collected, called~          apheresis. These cells will be modified to contain the anti-CD19 gene.~        -  Participants will have 3 days of chemotherapy to prepare their immune system to accept~          the modified cells.~        -  Participants will receive an infusion of their own modified white blood cells. They will~          remain in the hospital until they have recovered from the treatment.~        -  Participants will have frequent follow-up visits to monitor the outcome of the~          treatment.~        -  If the participant benefits from the treatment, then he/she may have the option for~          another round of treatment.~   "
150720|NCT01593683|"~     The purpose of this study is to test a brief education program for oncology nurses, to~     enhance their skills for managing psychosocial stressors associated with providing direct~     patient care. The investigators will explore efficacy of the intervention for reducing~     psychological stress and medical errors.~   "
150721|NCT01593670|"~     This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice~     daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer~     (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell~     survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The~     intent is to administer all treatment in the outpatient setting.~   "
150722|NCT01593657|"~     The purpose of this clinical trial is to understand if women undergoing surgery for a~     suspected gynecologic malignancy are interested in participating in a Mindful Movement and~     Breathing program and what the effects of this program are on women and the surgery-related~     symptoms they experience. Mindful Movement and Breathing programs may be effective for easing~     distress, post-surgical pain, and other symptoms of surgical procedures.~   "
150723|NCT01593644|"~     The purpose of this study is to evaluate the efficacy and tolerance of a~     dipyridamole/adenosine combination given intravenously, as a slow bolus and at low doses to~     adenosine alone (given at its recommended dosage adjusted to patients' weight) for coronary~     flow reserve assessment (in 60-75 patients with stable ischemic heart disease) using~     transthoracic echodoppler~   "
150724|NCT01593631|"~     Fermented dairy products, especially real Yoghurt, are often tolerated better by lactose~     malabsorbers than unfermented dairy products. The intake of dietary supplements containing~     acid Lactase derived from Aspergillus oryzae with lactose containing foodstuffs is known to~     reduce/alleviate symptoms of lactose intolerance in lactose malabsorbers. The study aims to~     compare the effect of the intake of a combination of yoghurt bacteria and acid lactase to the~     effect of yogurt bacteria or acid lactase alone on the lactose digestion in lactose~     malabsorbers. It is hypothized that the combination preparation will be more effective and/or~     will show a more reliable effect than the two mono-preparations.~   "
150725|NCT01593618|"~     This is a randomized controlled trial of a web-based informational intervention (UMFollowUp)~     for adolescent and young adult survivors of childhood cancer to improve cancer knowledge and~     psychosocial functioning.~   "
150726|NCT01593605|"~     The study will evaluate the effects of resveratrol/leucine and resveratrol/HMB for their~     ability to control glucose levels in persons without diabetes but with impaired fasting~     glucose. Secondary assessments will examine the effect of these nutritional supplements~     versus placebo on inflammation, fasting lipids, HbA1C, and fructosamine, longer term~     metabolic markers of risk in diabetes.~   "
150727|NCT01593592|"~     Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.~   "
150728|NCT01593579|"~     Some Akt inhibitors have produced functional cardiovascular effects such as marked~     hypotension that may limit their clinical benefit. There are no current data on whether this~     autonomic failure presents in humans at clinically used doses. We will test the hypothesis~     that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.~   "
150729|NCT01593566|"~     Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for~     analgesia after Anterior Cruciate Ligament (ACL) reconstruction.~   "
150730|NCT01593553|"~     The purpose of this study is to determine whether screening for atrial fibrillation by~     intermittent ECG recording and initiation of anticoagulation treatment among high risk~     individuals is cost-effective and can lower the incidence of stroke.~   "
150731|NCT01593540|"~     The aim of the study was to evaluate the clinical efficacy (Eastman Interdental Bleeding~     Index, Quigley and Hein) of a novel metal-free interdentalbrush compared to a classig~     metal-core interdental brush.~   "
150732|NCT01593527|"~     The purpose of this study is to confirm the efficacy and safety results obtained in a chronic~     kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger,~     independent patient population with difficult to treat gouty arthritis and moderate to severe~     CKD (stage 3 - 4).~   "
150733|NCT01593514|"~     The bacterium (germ) Neisseria meningitidis causes meningitis and blood poisoning. N~     meningitidis is classified into different serogroups (types), based on its outer~     polysaccharide (carbohydrate) capsule. Serogroups A,B,C,W & Y are responsible for the vast~     majority of meningococcal disease worldwide.~      Older vaccines against types A,C,W & Y contain part of the polysaccharide capsule of the~     germ. However, these polysaccharide vaccines do not provide long-term protection against~     disease and are less effective in young children, the group most at risk of meningococcal~     disease. Newer conjugate ACWY vaccines attach a polysaccharide to a protein carrier - these~     provoke a good response in young children and can provide long-term protection.~      White blood cells called B cells produce antibodies, which are the main components of~     protection against meningococcal disease. Although many studies have investigated the immune~     response to these vaccines in different age groups by measuring specific antibodies, there is~     limited information about the B cells underlying such an immune response. Several different~     subsets (populations) of B cells exist in the blood. Previous studies by the investigators~     group suggest that different numbers of B cells are produced in response to each vaccine~     type. However, little is understood about which subset of B cell is important for antibody~     production in response to these polysaccharide or conjugate vaccines.~      This study aims to provide detailed information on the immune response to meningococcal~     vaccines by investigating the appearance of B cells and their subsets in the blood after~     vaccination with the polysaccharide and conjugate vaccines. These observations will help us~     understand how polysaccharide and conjugate vaccines stimulate the immune system in different~     ways. This knowledge will help in the development of new vaccines that are effective across~     all age groups.~      The investigators aim to recruit 20 adults aged 30-70 from Oxfordshire. The study will be~     funded by the Oxford Vaccine Group.~   "
150734|NCT01593501|"~     The investigators aim to recruit 60 women who have agreed to participate in an existing~     randomized, double-blind, placebo-controlled trial (Treatment of Vitamin D Insufficiency, HSC~     2009-0055). In this trial, the investigators propose to evaluate the associations between~     magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis.~     The investigators will stratify 60 subjects in the sub-study, ensuring that approximately 20~     subjects are randomized into each treatment arm (placebo, low-dose and high-dose vitamin D).~     The investigators already assess calcium homeostasis throughout the study by measuring bone~     mineral density, fractional calcium absorption, serum and urine calcium levels, among other~     tests. In the sub-study of 60 women, the investigators will evaluate whether habitually~     higher magnesium intake increases or decreases fractional calcium absorption. The~     investigators will evaluate the interplay between magnesium stores, vitamin D levels and~     serum parathyroid hormone levels. The investigators will directly assess magnesium stores~     using serum magnesium and 24-hour urine magnesium levels, and will measure magnesium~     absorption using the dual stable isotope approach.~   "
150735|NCT01593488|"~     The purpose of this study is to describe the activity and toxicity of a new formulation of~     cytarabine called liposomal cytarabine given into the central nervous system for the~     treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in~     children and adolescents.~   "
173832|NCT01289756|"~     Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of~     Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.~   "
150736|NCT01593475|"~     This phase II trial chose the induction chemotherapy with gemcitabine and cisplatin followed~     by Chemoradiotherapy (CRT) with gemcitabine to optimize the treatment for pancreas cancer~     patients with locally advanced disease and the purpose of this trial is to evaluate the~     efficacy of induction CT with gemcitabine and cisplatin followed by CRT for unresectable~     pancreatic carcinoma.~   "
150737|NCT01593462|"~     The purpose of this study is to determine the efficacy of ultrasound imaging compared to MRE~     (Magnetic Resonance Enterography) a form of magnetic resonance imaging (MRI) in accurately~     diagnosing and following Small Bowel Crohn Disease (SBCD) in children.~   "
150738|NCT01593449|"~     The present study aims to initially test a community dog walking intervention that addresses~     individual, interpersonal and community factors associated with dog walking. The study will~     be conducted in two cities, Worcester and Lowell, as a collaboration between investigators~     from UMass Medical School and UMass-Lowell.~   "
150739|NCT01593436|"~     Summary~      Introduction: Insomnia is a symptom of sleep disorders most prevalent. Primary insomnia, the~     investigators analyzed, often related to stress states acquired, generalized anxiety and~     stress, which are important factors that disrupt normal sleep. The investigators point out a~     fact that still intrigue the students of medicine and sleep that is distorted perception of~     sleep by the sleepless nights, polysomnography shows greater effectiveness than that~     perceived by them. On the other hand, there is evidence that mindfulness techniques may~     reduce symptoms of stress and anxiety as well as improve the general attention, which may~     contribute to a better perception of the effectiveness of sleep. In addition, there are~     studies showing that meditation is associated with metabolic and neurophysiological~     characteristics similar to normal sleep. Objectives: To compare sleepless menopausal women~     trained for 8 weeks in the technique of mindfulness insomniac postmenopausal untrained and~     also assess the quality of sleep experienced meditators menopausal comparing them to the~     group of healthy postmenopausal women untrained in the art.~   "
150740|NCT01593423|"~     The project is a three arm randomized control trial in rural Cambodia designed to evaluate~     the impact of homestead food production (home gardens) with and without fish ponds versus~     control on household food security, dietary intake of women and youngest child, biochemical~     nutritional status of women, and household livelihoods over a 22 month period. Baseline and~     end line surveys will be conducted that involve questionnaires and a blood sample.~   "
150741|NCT01593410|"~     The purpose of this study is to determine the efficacy of lenalidomide plus low-dose~     dexamethasone in Chinese subjects with relapsed or refractory multiple myeloma.~      Even though the efficacy and safety of lenalidomide has already been well-demonstrated in~     other populations including Asians, this study will assess the efficacy and safety as well as~     pharmacokinetics of lenalidomide in Chinese subjects. In addition, this study will generate~     clinically meaningful information in guiding the therapeutic use of lenalidomide for Chinese~     subjects.~   "
150742|NCT01593397|"~     The primary objective of this study is to determine the influence of insulin resistance on~     drug metabolism and response in obese subjects. The investigators hypothesize that expression~     of adiponectin (a hormone secreted by fat tissue), and specific variants in the adiponectin~     gene can predict the insulin resistance and drug response among obese subjects.~   "
150743|NCT01593384|"~     Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion~     detection in dense breasted women. Even though DBT has been regarded as a study for dense~     breasted women, it may also improve lesion detection at an earlier stage and smaller size in~     women with less dense breast tissue. The overlapping of tissue on a standard of care 2D~     mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that~     mimic cancers. This leads to patients being asked to come back for additional imaging~     including mammogram and/or ultrasound images. DBT has shown to decrease call back rates by up~     to 43% in reader studies. Even though these results are promising they were not done in a~     realistic clinical setting.The purpose of this study is to evaluate the FDA-approved~     combination standard digital mammography (DM) and DBT technology and its impact on our~     clinical practice.~   "
150744|NCT01593371|"~     Oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients with~     type 2 diabetes. Thiazolidinediones (such a pioglitazone) and Biguanides (such as metformin),~     are two major groups of hypoglycemic medications that while function via different pathways,~     are both effective in short- and long-term glycemic control . These medications diminish or~     at least delay long term micro- and macrovascular complications associated with prolonged~     insulin resistance although at different rates. The mechanisms by which this aim is achieved,~     nevertheless, remains largely unclear. With adipokines playing a key role in development of~     both insulin resistance and atherosclerosis, oral hypoglycemic agents might regulate these~     substances by direct and indirect routes.~   "
150745|NCT01593358|"~     To establish if there are venous obstructions in patients with neurodegenerative disorders~   "
150746|NCT01593345|"~     The population is aging and chronic conditions, which are major causes of pain and mobility~     limitations, are on the rise, however, current access to physiotherapy is difficult.~     Knowledge on managing disability is substantial, but methods to translate into action are~     lacking. This project is designed to test a novel method of promoting function in vulnerable~     seniors and simultaneously develop awareness in the new generation of physiotherapists that~     they can have a proactive role in health promotion. The investigators are proposing a pilot~     project targeting both students and patients.~      The research question are (1) What are the needs of vulnerable patients at the MUHC? Two~     groups will be targeted; newly discharged seniors (who will be eligible for an intervention)~     and cancer outpatients who will be surveyed only);(2) For a senior population at risk for~     physical deterioration, to what extent is a personalized mentoring approach to optimizing~     function and preventing disability through developing self-management skills more effective~     in improving outcomes than the provision of written material covering the same general~     content? (3) Does a mentoring experience with vulnerable seniors through development and~     teaching of a self-management program (comprised of education and support) produce meaningful~     positive changes in future clinicians' knowledge, skills and attitude towards modes of~     delivering physiotherapy services and promoting self-management in Canadian seniors?~      There are two phases to this study: a survey and randomized controlled trial (RCT). The~     survey phase will identify mobility needs of two groups, newly discharged seniors and cancer~     outpatients. The needs assessment for newly discharged seniors will identify people eligible~     for the (RCT) component; the needs assessment for cancer outpatients will inform the~     development of interventions for this specific group. The RCT component will be piloted for~     recently discharged community dwelling seniors 70 years and older only.~      A sample of 400 seniors recently discharged from the adult, general, hospital sites of the~     MUHC will be contacted for a needs assessment. From this pool, the investigators anticipate~     100 will be eligible and 60 will be randomized, 30 to the mentor intervention and 30 to the~     control group. Participants will be followed-up for 6 months and assessments will be~     performed at 2 time points (baseline and 6 months). The main outcome is a standardized~     response ratio (SRR) estimated across all persons and measures. SRRs will be calculated for~     three groups of response variables: impairment/mobility measures, quality of life indicators,~     and health services outcomes.~      In parallel, to determine cancer survivor needs, the investigators will contact 600 cancer~     survivors; as the investigators anticipate 400 will answer the survey. The analysis of this~     survey will consist of frequency of specific needs by diagnosis and treatment.~   "
150747|NCT01593332|"~     In this project the investigators decide to evaluate the efficacy and safety of half dose~     mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of~     rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs~     limited in the investigators refractory patients as the first line drugs because of its cost.~   "
150748|NCT01593319|"~     The main hypothesis of the study is that anaesthesia of the hip using infiltration with a~     local anesthetic solution is preferable over traditional analgesia with oral opioid~     medications in the acute stage of the management of patients with a fracture of the hip.~      To study the hypothesis the investigators designed a prospective randomised study where~     patients are assigned in two groups, the first receiving local hip anesthesia and the other~     placebo treatment. Both groups are eligible to use of standard oral pain treatment.~      Effect of analgesia as well as medical complications will be recorded.~   "
150749|NCT01593306|"~     The purpose of this study is to check whether addition of paclitaxel to cisplatin and~     radiation therapy will improve the outcome in locally advanced carcinoma cervix.~   "
150750|NCT01593293|"~     The number of NSCLC patients above 70 years of age who are non-squamous histology is~     increasing around the world. Although previous guidelines often recommend single agent~     therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard~     monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with~     non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy~     in terms disease progression, overall survival, and quality of life and tolerability.~   "
150751|NCT01593280|"~     Morphine, when given as part of spinal anesthesia, is associated high incidence of nausea and~     pruritus, which may affect quality of recovery. The investigators hypothesize that~     long-acting local anesthetic infusions via TAP catheter can provide better quality of~     recovery after cesarean section than spinal morphine.~   "
150752|NCT01593267|"~     With evolving endovascular technologies there is a growing debate centered on the relative~     safety and efficacy of the currently accepted alternatives for the treatment of ruptured~     cerebral aneurysms in the face of acute subarachnoid hemorrhage (SAH). The purpose of this~     study is to compare the safety and efficacy of microsurgical clipping and endovascular~     coiling of acutely ruptured cerebral aneurysms in a prospective, randomized fashion.~   "
150753|NCT01593254|"~     The purpose of this study is to test the hypothesis that patients with CML who have not~     achieved optimal response after 3 months of treatment with imatinib will have a better~     response by switching to dasatinib compared to staying on their original imatinib regimen.~   "
150754|NCT01593241|"~     The main objective of this trial is to test the efficacy and safety of carboplatin~     chemotherapy and involved node radiotherapy in patients with stage IIA/B seminoma.~   "
150755|NCT01593228|"~     The purpose of this study is to assess the safety and tolerability of iniparib administered~     as monotherapy or in combination regimens in patients previously treated with iniparib in a~     clinical study and who have derived clinical benefit after completion of the parental study's~     objectives.~   "
150756|NCT01593215|"~     The investigators have recently discovered a genetic variant in an adrenergic receptor that~     leads to increased risk for type 2 diabetes. The investigators have also seen that blockers~     of that receptor improves impaired insulin secretion in animals. The investigators will now~     test the blocker in patients with type 2 diabetes with or without the risk variant in an~     effort to make diabetes treatment more individualized.~   "
150757|NCT01593202|"~     The purpose of the study is to evaluate the long-term efficacy of dialectical behavior~     therapy (DBT) in treatment of adolescents with deliberate self harm compared to enhanced~     usual care (EUC). This study follows-up 77 patients in the ages of 12-18 yrs who have been~     included in an RCT of DBT-A vs EUC. The main inclusion criterion for this study was~     repetitive self-harm behaviour. The patients were randomly allocated to receive 16 weeks of~     outpatient DBT or EUC in child and adolescent psychiatric clinics in Oslo. Participants have~     been assessed so far on five different time-points: baseline (before starting treatment), 9~     weeks, 15 weeks, 19 weeks and 71 weeks after start of the treatment. In the current project~     patients will be assessed a 6th time 2 years after treatment completion.~      The main study hypotheses are:~        -  DBT will be significantly more efficacious in reducing the number of self-harm episodes~          with or without intent to die, as well as reducing the number of emergency room visits~          for self-harm or suicidal behaviour, compared to EUC.~        -  DBT will be significantly more efficacious in reducing the level of suicidal ideation~          and depressive symptoms compared to EUC.~   "
150758|NCT01593189|"~     This study focuses on children entering kindergarten with co-occurring developmental~     disabilities and behavior problems, a population especially likely to have low levels of~     school readiness. Prior research has shown that children with developmental disabilities are~     at risk for academic difficulties. Behavioral and social problems are likely to interfere~     with school adjustment. The investigators hypothesize that children who receive the~     intervention will show better school readiness and school adjustment outcomes.~   "
150759|NCT01593176|"~     The investigators are doing this research study to look at how distal femoral fractures (knee~     bone break) heal. In this study, the investigators will use Radiostereometric Analysis (RSA)~     to look at how the pieces of femur bone move as the bone heals. RSA is a special x-ray that~     uses radiographs to measure very small movements in the bone over time. The question that~     will be answered by this study is whether RSA can be used as a tool to monitor fracture~     healing.~   "
150760|NCT01593163|"~     Patent ductus arteriosus (PDA) is a very common condition in immature newborn babies and it~     has been associated to morbidity and mortality. Ibuprofen is the drug of choice for PDA~     treatment according to the last version of the Cochrane review. Nowadays the best dose~     regimen for ibuprofen remains uncertain. The investigators aim to perform a randomized~     controlled clinical trial to assess whether echocardiographically guided PDA ibuprofen~     treatment versus standard treatment could reduce the number of doses of ibuprofen without~     increasing the reopening rate and reducing the side effects associated to this medication.~   "
150807|NCT01592539|"~     The effects of high serum glucose on bone could be direct or could be indirect through its~     effects on the microvasculature. Previous studies by Rendell et al and Brugler et al have~     found significant differences in skin blood flow between diabetics and control. The~     investigators are proposing that blood flow measurements of the skin may be correlated with~     bone remodeling rates in iliac bone biopsies.~   "
150761|NCT01593150|"~     Atrial fibrillation (AF) is the most common arrhythmia present in 1% of population under 60~     years of age and reaching up to 15% at 80 years. AF is associated with reduced quality of~     life, increased morbidity, mortality and health economic costs.~      Presentation of AF differs substantially among patients ranging from self-limiting short~     episodes (paroxysmal AF), longstanding episodes (persistent AF) where direct current (DC)~     cardioversion is needed, to chronic atrial fibrillation. Treatment of AF is individually~     tailored in accordance to symptoms, type of AF and thromboembolic risk. The standard~     treatment of symptomatic persistent AF is DC-cardioversion preceded by anticoagulant~     treatment with Warfarin. According to guidelines DC-cardioversion can be performed when~     anticoagulation treatment has been in therapeutic range for at least 4 weeks. However~     introduction of Pradaxa (Dabigatran) has enabled an earlier DC cardioversion, reducing time~     to cardioversion to a 3 week period. During anticoagulation treatment persistence of AF~     contributes to left atrial remodeling and increases in inflammatory and neurohumoral~     biomarkers. The prolonged duration of AF and the remodeling of the left atrium increase the~     risk of AF recurrence after DC-cardioversion.~      Early cardioversion of patients with persistent AF is possible if preceded by transesophageal~     echocardiography (TEE). The TEE guided DC- cardioversion, as demonstrated in the ACUTE study,~     is a safe and efficient alternative to conventional treatment. This treatment regime is not~     routinely used in clinical practice.~      The aim of this study is to compare early DC-cardioversion (within 72 hours) to conventional~     treatment (Pradaxa prior to DC-cardioversion). 140 patients with persistent AF will be~     randomized to early cardioversion preceded by TEE in accordance with guidelines or~     conventional treatment with Pradaxa for 4 weeks prior to DC-cardioversion.~      The investigators will determine the outcome in the two groups regarding:~        -  Left atrial function and size assessed by left atrial strain, left atrial ejection~          fraction and left atrial volume.~        -  Inflammatory and neurohumoral biomarkers including ANP, BNP,IL6 and CRP.~        -  Time to recurrence of AF (AF documented by ECG or Holter monitoring)~      Comprehensive transthoracic echocardiography, 12 lead ECG, biomarkers and Holter monitoring~     will be performed at the time of randomization, 4 weeks, 3 month and 6 month post~     DC-cardioversion. Furthermore all patients will be followed for symptomatic AF recurrence for~     a period of one year. AF recurrence will be documented by 12 lead ECG.~   "
150762|NCT01593137|"~     The process of atherosclerosis is multifactorial and involves many mechanisms. The majority~     of published works have identified endothelial dysfunction as the first step in a cascade of~     events that culminates in plaque formation. Among the various mechanisms that occur following~     the attack on the vessel wall, it is thought that stem cells in the form of endothelial~     progenitor cells (EPCs) are the endothelial protection mechanism.~      Factors identified as cardiovascular risk factors, or rather those conditions which suppose a~     threat to the vessel wall, should therefore be associated with low levels of EPCs. To date~     this link has been shown in hypertension, diabetes, hyperlipidaemia, and smoking.~     Furthermore, the lack of wall protection in situations of low levels of EPCs is clearly a~     biomarker of cardiovascular morbidity and mortality.~      On the other hand, the correction of a risk factor allows recuperation of EPCs and is~     therefore showing itself to be a promising tool for measuring therapeutic efficacy.~      The tools for correcting EPC levels are not clearly defined. The effect of statins on levels~     of EPC has been shown, and the low levels of EPCs in diabetes seem to be susceptible to~     treatment with statins.~      The role of glucagon-like peptide (GLP-1) is slowly being elucidated but the actual mechanism~     of its potential endothelial protection is unknown, and its effect on EPCs has not been~     studied.~      Liraglutide, a long-acting GLP-1 analogue, could also be an interesting option for long-term~     vessel wall protection, but to date its ability to correct cardiovascular biomarkers such as~     EPCs has not been studied.~   "
150763|NCT01593124|"~     This study investigates the response of vaginal and cervical tissue after exposure to three~     vaginal products: hydroxyethyl cellulose (HEC) placebo, nonoxynol-9 (N9) and imiquimod (IMQ)~     cream.~   "
150764|NCT01593111|"~     Exposure to household allergens is a major contributor to asthma symptoms. Aggressive~     measures to reduce household allergens has the potential to reduce asthma symptoms and the~     need for medications to control asthma. The investigators plan to enroll patients aged 6 and~     above into a single blind, randomized study comparing intensive environmental intervention~     with usual asthma care over a 48 week study period. All subjects will have asthma treatment~     optimized according to guideline based care. Subjects will be randomized to an aggressive~     environmental remediation arm versus distribution of written materials regarding allergen~     reduction (usual care). Primary outcome measure will be ability to reduce asthma step~     therapy. Secondary outcomes include measures of lung function, asthma biomarkers and quality~     of life.~   "
150765|NCT01593098|"~     To prospectively determine the prevalence of colorectal neoplasia in siblings of Hong Kong~     Chinese patients with advanced neoplasm compared with a sex and age-matched control~     population. To determine the molecular alteration profiles of colonic adenomas in siblings of~     patients with advanced neoplasm~   "
150766|NCT01593085|"~     The investigators propose a study that aims to develop a methodology for assessing this risk~     and the psychological consequences of the malignancy in the palliative phase.~   "
150767|NCT01593072|"~     The purpose of this study is to evaluate the safety and tolerability of healthy male and~     female subjects with intravenous (IV) infusions of AVI 7537 compared to matched placebo in~     and to evaluate the pharmacokinetics (PK).~   "
150768|NCT01593059|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
150769|NCT01593046|"~     LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety,~     tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a~     long acting parenteral (LAP) formulation in healthy subjects. Subjects will be randomized to~     3 monthly dosing cohorts and 1 quarterly dosing cohort with either intramuscular or~     subcutaneous dosing. In the monthly dosing cohorts subjects will receive GSK1265744 alone for~     2 months and then in combination with TMC278 long acting parenteral (LA) for 2 months. For~     the quarterly dosing cohort, 2 quarterly intramuscular doses of GSK1265744 LAP will be given~     alone. Three dose levels of GSK1265744 will be evaluated partly in combination with TMC278 LA~     to adequately characterize the GSK1265744 LAP and TMC278 LA safety, tolerability, and PK~     profile. A total enrolment of approximately 40 healthy subjects is planned for this study.~   "
150770|NCT01593033|"~     The purpose of this study is to investigate the therapeutic effectiveness of micronutrients~     (full RDA) and micronutrients + fish oil as separate interventions in restoring normal gut~     absorptive and immunological function as measured by the dual sugar permeability test and~     additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental~     Enteropathy.~   "
150794|NCT01592721|"~     The incorporation of novel targeted therapies to radiation therapy is of particular interest~     in head and neck cancer and may improve efficacy without significantly increasing toxicity.~     The investigators hypothesize that the addition of a second EGFR-targeted agent that inhibits~     EGFR at the intracellular level will improve the antitumor effect of standard radiation and~     cetuximab. The goal of this study is to evaluate the safety, efficacy, and the biologic~     effects in patients with locally advanced SCCHN of an antisense gene targeting the EGFR in~     combination with standard therapy with radiation and cetuximab.~   "
150771|NCT01593020|"~     The goal of this clinical research study is to learn if and how well eribulin, given in~     combination with standard chemotherapy, can treat early-stage breast cancer compared to~     paclitaxel given in combination with standard chemotherapy. In this study, the standard~     chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called~     FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).~      Eribulin is a changed version of the structure of a natural substance from a sea sponge. It~     is designed to block cells from dividing, which may cause cancer cells to die.~      Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.~      5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or~     stop their growth and spread throughout the body. This may cause the cancer cells to die.~      Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop~     their growth and spread throughout the body. This may cause the cancer cells to die.~      Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die.~      Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may~     slow or stop their growth and/or keep them from spreading throughout the body. This may cause~     the cancer cells to die.~   "
150772|NCT01593007|"~     Objectives: To evaluate regional lung ventilation distribution in patients suffering from~     chronic heart failure (CHF) after completing inspiratory muscle training (IMT) and correlate~     it with functional capacity and quality of life among these individuals. Methods and Results:~     Nineteen CHF patients were randomly assigned to two groups: Control and IMT. Before and after~     muscle training, subjects were submitted to assessment protocol for respiratory muscles,~     digital spirometry, optoelectronic plethysmography (OEP), the six-minute walk test (6MWT) and~     a quality of life questionnaire (MLHFQ). There was no difference in lung function following~     the 12-week training period in either group. However, the IMT group showed an increase in~     actual and predicted MIP, higher MLFHQ score and greater distance walked in the 6MWT, as well~     as a reduction in the Borg scale after the 6 MWT in relation to the control. For the OEP, IMT~     group members exhibited higher values for total chest wall volume (Vcw), abdominal rib cage~     volume (Vrc,a) and abdominal volume (Vab) when compared to the control. Conclusions: For~     patients with CHF, IMT proved efficient in improving muscle strength, functional capacity and~     quality of life. The present study also analyzed the distribution behavior of lung volumes~     for the thoracoabdominal system in this population, showing that larger abdominal rib cage~     and abdomen volumes may result in more effective diaphragmatic contraction.~   "
150773|NCT01592994|"~     This grant involved the development, implementation, and assessment of the feasibility and~     acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives~     (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was~     adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV~     intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was~     from their primary male partner (Raj et al. 2001).~      Specific aims of this study are as follows:~        1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with~          demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use~          with at-risk Indian wives.~        2. To determine the feasibility and acceptability of RHANI Wives with at risk wives* in~          India. A two-group cluster randomized trial will involve random assignment of 12~          neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a~          control condition (n=150). Intervention effects on the more proximal and likely safer~          sex mediating outcome of marital communication for this feasibility trial will be~          assessed via surveys at baseline and 3 month follow-up.~      NOTE: Only 220 participants were able to be recruited into the study.~      *At risk wives are defined as having a husband at higher risk for transactional sex based on~     wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7~     days) or partner violence perpetration~   "
150774|NCT01592981|"~     The purpose of this trial is to assess tolerability and efficacy of the Bortezomib,~     Cyclophosphamide and Rituximab combination as initial therapy for previously untreated~     patients with symptomatic Waldenstrom's macroglobulinaemia.~   "
150775|NCT01592968|"~     The goal of this clinical research study is to compare stereotactic radiosurgery to whole~     brain radiation therapy in patients with 4-15 non-melanoma brain tumors.~      Stereotactic radiosurgery is the delivery of focused, high-dose radiation given in a single~     session to the tumors with a minimal dose given to uninvolved areas of the brain.~      Whole brain radiation is the delivery of lower dose radiation to the entire brain given daily~     over 2 weeks.~      This is an investigational study. It is considered investigational to compare stereotactic~     radiosurgery to whole brain radiation therapy in patients with 4-15 non-melanoma brain~     tumors.~      Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.~   "
150776|NCT01592955|"~     The purpose of this study is to evaluate the effectiveness and the safety of the~     cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma~     patients~   "
150777|NCT01592942|"~     This is a prospective, randomized multi-centre study to find out most safe, feasible,~     painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh~     fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein~     operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to~     conventional Lichtenstein technique.~   "
150778|NCT01592929|"~     In this study the possible changes in upper airway geometry induced by variations in the~     characteristics of the mouthpieces of inhalers will be evaluated with functional respiratory~     imaging (FRI) and Pharyngometry. The study population consists of 12 healthy male subjects.~      Different mouthpiece designs will be evaluated for each subject by using magnetic resonance~     imaging (MRI) scans. The results will help to identify the influence of the height, width,~     protrusion and resistance of the mouthpiece on upper airway geometry.~      Pharyngometry profiles of all subjects, whilst inhaling through different mouthpiece~     variants, in supine and upright position, will be completed.~      A computed tomography (CT) scan and a cone beam computed tomography (CBCT) scan of the upper~     airway will be taken to respectively compare the time dependence on 3D imaging with MRI and~     to provide a 3D image in an upright position.~      Dental impressions will be optically scanned to obtain a more accurate representation of the~     oral cavity, mainly in MRI.~   "
173833|NCT01289743|"~     The study has the aim to investigate the efficacy and safety of etanercept in patients with~     active ankylosing spondylitis (AS) over 520 weeks.~   "
150779|NCT01592916|"~     The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have~     shown that exercise improves body functions and/or symptom severity in most patients, but not~     in all. About a third of patients with FM have been shown to have low levels of IGF-1. The~     purpose of this project is to study individual and biological factors that interact with~     outcomes of short-term (acute) exercise in FM.~      Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy~     age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer~     bicycle exercise tests will be conducted in feasting patients, separated by one month. The~     first exercise test is at a low and the second at a high intensity. Measurements comprise~     blood test, pain rating and pain threshold, conducted before and after the test. The levels~     of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health~     status and pain.~   "
150780|NCT01592903|"~     The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC)~     responsible for the formation and growth of leiomyomas using the Side Population method.~   "
150781|NCT01592890|"~     This single-center, open-label study will assess the excretion balance, pharmacokinetics and~     metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive~     a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled~     RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up~     to 15 weeks.~   "
150782|NCT01592877|"~     To verify the accuracy and reliability of the ultra wideband (UWB) non-contact breath rate~     and heart rate monitor, ICU bedside monitor is used as the gold standard.~   "
150783|NCT01592864|"~     A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing~     dentinal hypersensitivity over an eight week treatment period.~   "
150784|NCT01592851|"~     A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing~     dentinal hypersensitivity over a two week treatment period.~   "
150785|NCT01592838|"~     This study aims to investigate whether a change in the pattern of hospitalisation was~     observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change~     in staff workforce availability was observed in paediatric wards over the last 6 years~     (during a whole year or during specific time periods of the year) and if changes of any of~     the variables measured during the observation period could be linked to the introduction of~     rotavirus vaccination.~   "
150786|NCT01592825|"~     The improvement of the healing rates for breast cancer is based to an important part on the~     consistent use of so-called adjuvant (supporting ) medicamentous therapies, including~     chemotherapy. However this success has a price due to still inaccurate knowledge of the~     individual risk of relapse: a high number of unnecessary therapies are applied~     (over-therapy!). The invasion factors uPA (plasminogen activator of the urokinase type) and~     PAI-1 (uPA inhibitor) were described extensively as strong and independent prognosis factors~     with high clinical relevance for patients with node negative breast cancer. Compared to~     clinical and pathological factors (further: traditional factors ) they show better~     estimation of the relapse risk leading to an avoidance of redundant adjuvant chemotherapy and~     may thus essentially contribute to the improvement of the quality of life in these women. In~     this study we aim to evaluate, how large the portion of the patients with early, operable,~     node negative breast cancer will be, in whom, by improved low-risk identification through~     uPA/PAI-1, adjuvant chemotherapy can be omitted.~   "
150787|NCT01592812|"~     Stimulation of arterial inflow to the lower limb is important to obtain functional~     improvement in peripheral artery diseased (PAD) patients with claudication. The clinical~     effect of muscle stimulation to increase arterial inflow and the direct evaluation of the~     regional blood flow impairment (RBFI) in the area of stimulation, have not been evaluated in~     PAD patients.~      Fifteen adult patients with stable arterial claudication will participate. Recruitment will~     be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope)~     After two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an~     increasing frequency rate with 5 min steps (1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz) on the most~     symptomatic side.~      The investigators record the tcpo2 value, arterial blood inflow with ultrasound of the~     femoral artery, and near infra-red spectrometry (NIRS) on both sides.~      Patients will be instructed to report eventual contraction-induced pain in the stimulated~     calf.~   "
150788|NCT01592799|"~     This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed~     influenza, and compare the clinical features, severity, complications, risk factors and~     socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI)~     and/or isolated fever, with or without laboratory-confirmed influenza.~   "
150789|NCT01592786|"~     The purpose of this study is to evaluate the safety and tolerability of memantine in~     pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive~     Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for~     participation in a follow-up randomized withdrawal study.~   "
150790|NCT01592773|"~     The objective of this study is to evaluate the long-term safety and tolerability of memantine~     in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive~     Developmental Disorder Not Otherwise Specified (PDD-NOS).~   "
150791|NCT01592760|"~     The air-Q Self-Pressurizing Intubating Laryngeal Airway (aILA SP) is a modification of the~     air-Q Intubating Laryngeal Airway (aILA). Besides the i-gel, it is the only breathing tube~     that sits above the vocal cords that does not require inflation of a cuff with air. The~     purpose of this study is to compare the ability of the aILA-SP to maintain patency of a~     patient's airway during general anesthesia with that of the aILA and i-gel devices. As a~     measure of this ability, we hypothesized that the airway sealing pressures will be equal~     between the aILA-SP and aILA, but superior when comparing the aILA-SP to the i-gel (i-gel~     will be lower).~   "
150792|NCT01592747|"~     This clinical study will be a 12-week, multicenter, double-blind, placebo-controlled,~     randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or~     Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). The objective is to~     evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo.~   "
150793|NCT01592734|"~     The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of~     a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal~     impaction and in the treatment of chronic constipation~   "
150796|NCT01592695|"~     The proposed work is designed to help increase access to tobacco cessation services among~     rural veterans and to develop more effective treatment services that better address comorbid~     issues commonly experienced by rural smokers. The objectives are:~        1. Study the feasibility of an individually-tailored telephone intervention for rural~          smokers.~        2. Examine the impact of the intervention on tobacco use outcomes.~        3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers~          including depressive symptoms, alcohol use, and weight gain.~   "
150797|NCT01592682|"~     This is a trial of household pairs of a Chinese smoker and nonsmoker randomized either to a~     smoke-free educational intervention or self-help control group. The smokefree educational~     intervention includes group education about smokefree environments and smoking cessation,~     follow-up phone calls, and tobacco exposure lab reports. The control group is referred to~     usual care with local in-language smoking cessation classes or quitline, and is otherwise~     assessment only. The investigators hypothesize that pairs in the intervention group will have~     higher rates of tobacco cessation and elimination of smoke exposure, compared to the control~     group.~   "
150798|NCT01592669|"~     Background:~      The pneumatic tourniquet is frequently used in total knee arthroplasty. Tourniquet deflation~     may result in hypotension and tachycardia caused by the rapid shift of blood volume back to~     the ischemic limb and a decrease in cardiac preload. Passive leg raising (PLR) represents a~     self-volume challenge that can result in an increase in preload. Such a PLR-induced~     increase in preload was hypothesized to attenuate the decrease in preload resulting from~     tourniquet deflation. This study was designed to evaluate the effect of PLR on hypotension~     and tachycardia following tourniquet deflation.~      Methods:~      Seventy patients who underwent unilateral total knee arthroplasty were assigned to either the~     bilateral PLR group (n = 35) or the control group (n = 35), in a prospective randomized~     trial. The patients' blood pressure and heart rate were measured before, during, and after~     tourniquet deflation.~   "
150799|NCT01592656|"~     In this multicenter study the comparison of the mass flow distribution and redistribution~     versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q)~     matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will~     be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore~     a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with~     non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan~     will be used for FRI.~   "
150800|NCT01592643|"~     The purpose of this research is to determine if an investigational thin shield over the~     cornea can safely and effectively reduce or eliminate pain following Post Photorefractive~     Keratectomy (PRK).~      The thin shield is made of silicone. The materials used to make the corneal shield all have a~     history of use in medical devices, contact lenses, and/or corneal shields and have been used~     safely in the eye.~   "
150801|NCT01592630|"~     The control of postoperative pain has become a major issue in surgery awareness and it is~     considered an important measurement of patient satisfaction. Improvements in pain relief,~     including stopping pain before it starts (i.e. preemptive treatment) is of great benefit to~     the surgical patient. When pain is aggressively addressed, patients respond by recovering~     faster.~      The use of opioids remains the mainstay to minimize postoperative pain. Lately, long acting~     local anesthetic wound infiltration has been widely recognized as a useful adjunct to~     multimodal postoperative pain management. On that basis, a system that delivers a continuous~     local anesthetic to the surgical wound was developed, and better pain control has been~     achieved after several surgical procedures.~      In patients undergoing abdominal procedures, such as colon resection, adequate pain control~     remains an issue. It is known that innervation to the antero-lateral abdomen is provided by~     sensory nerves T7-L1, ilioinguinal and iliohypogastric nerves, which travel through the~     transverse abdominis muscle plane (TAP). Local anesthetic block of these nerves has been~     described and has shown to be effective for immediate postoperative pain control.~      Recently, the use of the On-Q pain relief system with catheters placed within the TAP has~     been evaluated. Published results have shown significant improvement of pain control~     (Forastiere). The idea of placing the pain catheters at the TAP plane seems to be more~     coherent with the anatomical distribution of the sensory nerves trunks. Due to the lack of~     prospective trials investigating the effectiveness of a continuous wound infusion with local~     anesthetics after general surgery procedures the investigators sought to determine the~     efficacy of this technique after laparoscopic colon resection procedures.~   "
150802|NCT01592617|"~     The investigators identified three cancer-testis antigens, as targets for cancer vaccination~     against lung cancer. In this clinical study, the investigators examine using a combination of~     three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor~     effect of vaccine treatment for advanced non-small cell lung cancer patients.~   "
150803|NCT01592604|"~     Avulsion fractures of the base (tuberosity) of fifth metatarsal bone are the most common~     fractures in the foot, frequently treated in fracture clinics and involving significant~     resources. At present methods of treatment and follow up vary widely from no active treatment~     to surgery, depending entirely on a treating doctor preference. There is no agreement on~     simple, safe and reliable method of treatment. The investigators believe that vast majority~     of these injuries heal well on its own without any specific treatment. By comparing two most~     commonly used treatments the investigators aim to establish one simple, safe and reliable~     mode of treatments. The investigators are going to evaluate functional results of these two~     treatments in a short and longer time prospective, by using the best available scientific~     tools. The investigators believe that results of the investigators study will eventually lead~     to change of practise and more efficient NHS care for these patients. It will reduce~     unnecessary treatments and clinic appointments, and bring substantial savings to the NHS in a~     long prospective.~   "
150804|NCT01592578|"~     The purpose of this study is to evaluate the efficacy of two different endoscopic treatment~     in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus~     sclerotherapy in addition to cyanoacrylates~   "
150805|NCT01592565|"~     This study is being done to demonstrate a powerful new method for detecting heart disease~     that combines the proven prognostic capability of exercise stress testing with the superior~     image quality of Cardiac Magnetic Resonance Imaging (CMR). The investigators hope to~     demonstrate that exercise CMR has equivalent or superior diagnostic accuracy compared to~     exercise stress SPECT for detecting obstructive artery disease.~   "
150808|NCT01592526|"~     Critical illness, severe infection, extensive trauma or tissue damage cause an inflammatory~     (irritative) reaction in the body. This reaction affects the whole body and causes malaise,~     circulatory and cardiac changes, fever, increases the number of white blood cells in the~     blood stream and prompts release of signaling proteins. This reaction contributes to the~     development of considerable organ damage and possibly organ failure. These are serious~     complications in critical illness which are associated with a high mortality. This~     inflammatory reaction is affected by the autonomic nervous system. This is the part of the~     nervous system, which is beyond the control of the free will, and the part that regulates~     circulation, breathing and digestive functions. The autonomic nervous system works via~     so-called sympathetic signals, which set the body in a state of alertness to overcome~     immediate challenges, and parasympathetic (vagal) signals, which are especially active during~     restitution and rest. It is known, that the balanced activity in the autonomic nervous system~     affects the body's inflammatory response in critical illness. A study in mice has shown that~     if parasympathetic (vagal) signals are blocked mortality in critical illness is increased.~     Reversely, when the autonomic nervous system is medically stimulated towards parasympathetic~     signaling, the magnitude of the inflammatory response is decreased. Nicotine exerts this~     stimulatory effect.~      Also, we know that individuals in good physical shape have increased parasympathetic tone~     compared to less trained individuals. However, studies have never addressed whether this~     shifted balance in the autonomic nervous system affects the inflammatory response related to~     critical illness.~      Over the last 30 years an experimental model mimicking the inflammatory response has been~     used in studies. Inflammation may be simulated by injecting the drug E.Coli LPS, which~     induces a controlled, fully reversible, harmless reaction the duration of which is a few~     hours. Influenza-like symptoms occur and changes in circulatory parameters and concentrations~     of signaling proteins can be measured.~      Using this experimental model, the investigators wish to study whether this shifted balance~     in the autonomic nervous system in individuals in good physical shape affects the body's~     reaction to critical illness. Investigators also want to determine how nicotine (using a~     nicotine patch) affects this reaction.~   "
150809|NCT01592513|"~     In this research, the investigators will asses the effect of BIS monitoring on propofol usage~     during elective flexible fiberoptic bronchoscopy.~      The investigators will examine whether use of BIS monitor enables reduction of sedative dose~     during bronchoscopy.~      The investigators will also examine whether administration of lower total sedative dose~     enables prevention of possible complications.~   "
150810|NCT01592500|"~     This is a phase II, open label, active-controlled, randomized safety and dose finding study~     of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth~     hormone deficient children.~   "
150811|NCT01592487|"~     This study is designed to test how breakfast affects brain function, memory and learning in~     healthy children.~      Hypotheses: Based on the results of our initial study and the relevant literature, it is~     hypothesized that arousal, attention, and performance will be:~        1. Greater in those who eat breakfast relative to those who do not;~        2. Greater in lean than in overweight children receiving the higher protein breakfast;~        3. Greater in fasting lean than fasting overweight children; and~        4. Improved following a morning snack in all study groups.~        5. Poorer in children with higher stress-related measures (e.g., higher cortisol levels).~        6. Heart rate will be lower in fasting relative to fed participants, and across groups will~          be higher in overweight children.~   "
150812|NCT01592474|"~     The purpose of this study is~        -  To examine if Avaonex can delay the development of clinically definite multiple~          sclerosis.~        -  To investigate if Avonex can delay disability progression by slowing brain atrophy.~   "
150813|NCT01592461|"~     The purpose of the study is to conduct a follow-up of substance abuse patients (n=1,269)~     about 2 to 5 years since they were originally recruited from 8 substance abuse treatment~     clinics (located in 5 states) to participate in a prior clinical trial study called START~     (Starting Treatment with Agonist Replacement Therapies). The START Follow-up Study will be~     conducted over 5 years and will involve three follow-up interviews with START participants.~      The specific aims of the START Follow-up Study are as follows.~        1. To determine longer-term outcomes of Suboxone versus methadone treatment received in the~          START~        2. To investigate patient and treatment factors associated with post-START treatment~          access, utilization, and outcomes among Suboxone and methadone patients~        3. To explore other correlates of the long-term outcomes among START patients.~   "
150814|NCT01592448|"~     The purpose of this study is to evaluate, through brief, one-on-one cognitive interviews, the~     efficacy of 'enhanced' acetaminophen messages and icons in improving consumer understanding~     and use of prescription (Rx) and non-prescription (over-the-counter, OTC) acetaminophen~     containing products compared to the current standard.~   "
150815|NCT01592435|"~     The study objective is to acquire composite images generated by the Carestream Long Length~     Imaging (LLI) software and demonstrate that the images stitched using the Carestream LLI~     software and the images stitched using a approved predicate device are acceptable for~     clinical use.~   "
150816|NCT01592422|"~     The role of maintenance therapy in the management of Small Cell Lung Cancer (SCLC) has not~     been confirmed. Many treatment modalities like chemotherapy, interferons and other biological~     agents have been tested as maintenance therapy in SCLC, but the results are disappointing. A~     marginal survival advantage is seen in maintenance with chemotherapy and interferon-alpha,~     however, the functioning status and immune system may get worse, which subsequently has a~     negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced~     killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune~     response and altering the interaction between tumor and its host. This effect may result in~     improved tumor control and survival, as well as a better quality of life. To test the~     hypothesis, a randomized controlled study was conducted to compare CIK cells with best~     supportive care as maintenance therapy for SCLC.~   "
150817|NCT01592409|"~     Motor vehicle collisions are the leading cause of death for young people. The investigators~     have recently found that driving after using cannabis is more common among young Canadian~     drivers than driving after drinking. While this observation raises concerns, the effects of~     cannabis on driving-related skills in this age group are not well understood. As well,~     evidence suggests that residual effects of cannabis on driving-related skills may be observed~     up to 24 hours later. These residual effects may have important implications for the effects~     of cannabis use on collision risk, but little evidence on them in available. This study will~     examine the effects of a single dose of cannabis (marijuana) on driving-related skills~     immediately following consumption, 24 hours later, and 48 hours later. To date, the residual~     effect at 48 hours has not been examined. A total of 142 subjects aged 19 to 25 years old~     will be randomly assigned to smoke either a placebo or active cannabis cigarette (12.5% THC~     potency). Following an eligibility screening and practice session, participants will attend 3~     testing days; drug-administration, 24-hour follow-up and 48-hour follow-up. The effects of~     cannabis/placebo on performance of driving-related skills using a high-fidelity driving~     simulator will be assessed on each testing day. The effects of cannabis on mood, cognition,~     memory and complex reaction time will also be assessed. Identifying factors that affect the~     collision risks experienced by young drivers is a public health priority. While many young~     people believe that cannabis does not impair driving, some recent studies suggest that these~     may be very dangerous beliefs. This study will provide important information on how cannabis~     may affect the driving skills of young drivers, to inform efforts to understand and address~     cannabis-related collision in this age group.~   "
150818|NCT01592396|"~     The pharmacokinetic (PK) profile of tralokinumab (CAT‐354) will be studied in adolescent~     subjects with asthma.~   "
150856|NCT01591902|"~     To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of~     Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and~     Type 2 diabetes mellitus (T2DM).~   "
150819|NCT01592383|"~     The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people~     with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer.~     Erlotinib has been approved by the United States Food and Drug Administration (FDA) for other~     cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma. This~     research is being done because there is no current standard treatment for malignant~     peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant~     peritoneal mesothelioma.~   "
150820|NCT01592370|"~     The purpose of this study is to determine the side effects of treatment of the combination of~     nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.~   "
150821|NCT01592357|"~     Cardiac exercise rehabilitation consists of walking and bicycling activities. As the~     population requiring rehabilitation is aging, other forms of exercise may be useful and~     better tolerated. Tai Chi has been used for centuries, is easy to perform even by more~     debilitated individuals, and promotes improvement in blood pressure, fitness, and relaxation.~     Tai Chi may be more beneficial for frail cardiac patients because it is especially suited for~     the unfit and elderly, and can be practiced anywhere. Further studies are required to assess~     this form of exercise in cardiac patients. The objective of this randomized controlled study~     is to compare the effects of Tai Chi to sham exercise training in 200 frail cardiac~     patients who have completed six months of cardiac rehabilitation and are 60 years of age or~     older. Participants will be randomized to Tai Chi or sham exercise training and have their~     gait speed, blood pressure, heart rate, exercise capacity, balance, quality of life and~     cognitive function assessed before and after 24 week of training.~   "
150822|NCT01592344|"~     The purpose of this study is to investigate whether the StimRouter (SR) electrical~     stimulation therapy leads to clinically important pain relief in patients with chronic~     intractable pain of peripheral nerve origin after three months of treatment. At the same~     time, this study will gather information on side effects associated with the StimRouter~     electrical stimulation therapy.~   "
150823|NCT01592331|"~     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the~     pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.~      Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or~     placebo. In-unit period is 6 days.~   "
150824|NCT01592318|"~     This randomized, open-label, crossover study will evaluate the relative bioavailability of~     ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc~     combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects~     will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an~     FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a~     crossover design, subjects will participate in 3 study periods with at least a 7-day washout~     between periods. In Part 2, single dose administration of film-coated FDCs will be compared~     to reference tablets.~   "
150825|NCT01592305|"~     This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study~     will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered~     with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in~     healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral~     doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2,~     all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study~     treatment is up to 20 days.~   "
150826|NCT01592292|"~     This prospective, multi-center, observational study will evaluate the efficacy and the safety~     of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or~     have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera~     or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be~     collected for 12 months.~   "
150827|NCT01592279|"~     The new incretin-based therapies offer appealing advantages over existing drugs. Aside from~     glucose dependent insulin secretion and a proven glucose lowering efficacy, they have other~     concomitant beneficial effects, such as low risk of hypoglycemia, inhibition of the glucagon~     secretion with maintenance of counter-regulatory mechanism, promotion of weight loss, and~     possible cardiovascular benefits (improvement of lipid profile, blood pressure, endothelial~     and myocardial function). The glucose lowering effects resulting from the inhibition of~     glucagon secretion and the gastric emptying rate could be of clinical importance in type 1~     diabetes.~      The rationale behind the use of GLP-1 analogues in the treatment of type 1 diabetes relies on~     the assumption that these drugs, in addition to their action on insulin secretion and glucose~     regulation, may be effective in preserving and even expanding the β-cell mass. This class of~     drugs may represent an entirely new approach to the treatment of type 1 diabetes, focused on~     protection and preservation of β-cells. These therapies have the opportunity to interfere~     with the disease progression if used as an early intervention, when enough β-cell mass/~     function can still be preserved or restored.~      Hypothesis:~      GLP-1 analogue (liraglutide) will improve glycemic control as measured by HbA1c in~     uncontrolled type 1 diabetic patients. The investigators expect a reduction of 1% in HbA1C~     from baseline.~   "
150828|NCT01592266|"~     PET/CT is reliable tool in evaluation of treatment response in number cancers. F18-FLT is a~     precursor of DNA with high uptake in the bone marrow as a part of normal biodistribution.~     Highly increased uptake of this radiopharmaceutical was shown in a number of hematologic~     disease either in bone marrow or extramedullary.~      F18-FLT PET/CT can provide a tool for whole body assessment of activity in bone marrow as~     well as early estimation of treatment efficacy or lack of it. In addition, this noninvasive~     study can replace bone marrow biopsy and predict response vs. non response to therapy.~   "
150829|NCT01592253|"~     For patients who meet the inclusion criteria and who agree to participate in this study, the~     investigators sampled peripheral blood 10cc and performed the analysis for immunologic~     profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year~     from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha~     analysis fo immune profile again. During the study period, the interval of the visit of~     subclinic and the kinds of laboratory test (Blood and urine test) would not change compared~     to before the start of this study.~   "
150857|NCT01591889|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Tinidazole 500 mg Tablet under fed conditions.~   "
150832|NCT01592214|"~     This is a Phase I, multi-center, clinical study of XF-73 to evaluate the local (nasal) safety~     and tolerability of a modified, thinner lower viscosity formulation of intranasal XF-73 in~     healthy male and female subjects. In addition, the potential for systemic absorption of XF-73~     in the modified, thinner lower viscosity and the previously investigated thicker, higher~     viscosity formulations and their decolonization efficacy in comparison to placebo will be~     evaluated. Both parts of the study will be double-blinded and Part 2 will also be~     placebo-controlled. Primary objective is to establish the safety and tolerability of two~     concentrations of a modified thinner, lower viscosity nasal formulation of XF-73 and to~     compare them to a previously investigated, thicker, higher viscosity formulation~   "
150833|NCT01592201|"~     The purpose of this study is to compare the patient satisfaction between continued~     administration of previous antipsychotics versus switched administration to paliperidone ER~     in non-satisfied patients with previous (paliperidone)~   "
150834|NCT01592188|"~     This project will explore the effect of Cognitively-Based Compassion Training or mindfulness~     training on behavior and saliva stress hormones in elementary school-age children.~   "
150835|NCT01592175|"~     The tight relationship between attention and conscious perception makes them difficult to~     study in isolation and has led many scientists to closely link these two processes. However,~     while some authors argue that conscious perception cannot occurs without attention,~     magnetoencephalography (MEG) and fMRI studies had shown that attention and consciousness are~     two distinct brain processes.~      If endogenously triggered attention and consciousness are dissociated, it has been proposed~     that orienting of exogenous attention is a necessary, though not sufficient, antecedent of~     conscious perception.~      In the present study we used MEG to explore the neural correlates of exogenous attention and~     consciousness during visual processing.~   "
150836|NCT01592162|"~     The objective of this study is to evaluate the influence of different propofol formulations~     (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is~     administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.~   "
150837|NCT01592149|"~     The study is an epidemiological survey to find out the incidence of loss of appetite in~     Indian patients suffering from various health disorders. This survey will be conducted to~     obtain information on appetite from a total of 17500 subjects This study does not intend to~     study the effect of any drugs. The primary source of information will be the subjects~     themselves. The study will be conducted at 275 - 350 centres spread across India.This is a~     single visit study.The physician will conduct routine clinical, physical and general~     examination.~   "
150838|NCT01592136|"~     This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic~     myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic~     leukemia (Ph+ALL) who have failed all available treatment options.~   "
150839|NCT01592123|"~     The aim of this report was to assess the frequency of poor sleep quality, daytime and dream~     anxiety and their response to subsequent surgical treatment for a representative group~     patients with nasal septum deviation.~   "
150840|NCT01592110|"~     This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three~     doses of risperidone-SABER, administered with a needle and syringe or via the DosePro~     Needle-Free Delivery System in patients with chronic, stable schizophrenia.~   "
150841|NCT01592097|"~     Gilenya (fingolimod) is approved for multiple sclerosis. However, it is unclear of its~     clinical effect in the Hispanics with MS given that clinical studies had limited~     representation of this population. It is also unclear if Gilenya would be as effective in~     individuals with disease predominantly affecting the optic nerve and spinal cord (OSMS)~     commonly seen in Asian populations.~      Objectives: To compare the clinical response of Gilenya® (fingolimod) in relapsing remitting~     OSMS and MS of Hispanic descent using ancestral markers as a biomarker of treatment response~     and clinical disease state.~   "
150842|NCT01592084|"~     The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis~     (ALS) pathophysiology and its impact on disease progression and survival is unclear. The~     investigators analyzed the correlation between lipid levels with disease progression and~     survival in ALS patients and the association of LLT with these outcomes.~   "
150843|NCT01592071|"~     This study assessed the effect of an IgG-mediated food sensitivity test in combination with a~     food elimination diet on body composition and secondary outcomes in people who were~     overweight.~   "
150844|NCT01592058|"~     The purpose of this study is to learn whether women who use progestin-only methods of birth~     control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS~     (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared~     to women using the non-hormonal copper IUC (ParaGard).~      The investigators primary hypothesis is that users of DMPA will gain excess weight and~     increase their BMI above the copper-IUC users; secondarily, the investigators will compare~     users' data in the LNG-IUC and ENG implant groups to the copper-IUC group.~   "
150845|NCT01592045|"~     The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of~     chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or~     the National Cancer Institute [NCI]).~   "
150846|NCT01592032|"~     The antibiotic lock technique (ALT) is used as local treatment for Catheter-Related~     Bacteremia (CRB). It consists in the administration of a concentrated antimicrobial solution~     with a calculated volume to fill the lumen of the catheter. The lock solution is indwelled~     within the catheter for a defined period of hours or days before been removed.~      Currently, the Infectious Diseases Society of America (IDSA) Guidelines for treatment and~     management of CRB, recommends to change the antibiotic solution every 24 hours.~      The investigators expect to determine the stability of the concentration of vancomycin,~     teicoplanin, linezolid, daptomycin and tigecycline used in lock solutions, and thus to assay~     the optimal timeframe that the concentration of antibiotic used in lock solution keeps its in~     vivo antimicrobial activity.~      Study Hypothesis: An antibiotic lock solution maintains in vivo concentration and~     antimicrobial activity for at least 10 days after its infusion inside a subcutaneous port~     catheter.~   "
150858|NCT01591876|"~     The aim of this study is to evaluate whether a three month intra-dialytic exercise programme~     improves arterial function.~   "
150847|NCT01592019|"~     The investigators hypothesize that a technique called microdialysis can be used to measure~     the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin.~     Microdialysis uses a small device called a 'probe' to determine the amount of drug which~     enters a body tissue. The small device is placed directly in the fatty tissue and samples are~     taken at specific times. The investigators will determine whether site of application affects~     the availability of the drug.~   "
150848|NCT01592006|"~     Patients are being asked to be part of this study because they are a liver transplant~     recipient and have the Hepatitis C Virus (HCV). Current routine treatment for HCV for liver~     transplant patients includes taking two medications called pegylated interferon alfa-2a~     (Pegasys®) and ribavirin. Patients Pegasys and ribavirin are FDA approved for the treatment~     of HCV.~      This study will evaluate the safety and efficacy of adding a third drug called telaprevir for~     the experimental treatment of HCV in liver transplant patients. The combination of Pegasys,~     ribavirin and telaprevir is currently FDA approved for the treatment of HCV, but is~     specifically not FDA approved for HCV patients who have had a liver transplant. This is~     because more information is needed about possible drug interactions between telaprevir and~     cyclosporine, or telaprevir and tacrolimus-based immunosuppressive drugs, which are typically~     part of routine care for transplant patients.~      Studies have shown that the addition of telaprevir greatly increases the efficacy of Pegasys~     and ribavirin for the treatment of HCV. However, these studies did not include adequate~     information on transplant patients due to the potential drug interactions.~      The investigators hope to gather more information about the safety and efficacy of telaprevir~     given in combination with Pegasys and ribavirin in the liver transplant patients who have HCV~     that is not well controlled with Pegasys and ribavirin alone.~   "
150849|NCT01591993|"~     Sensitive skin syndrome is a frequent self-diagnosed entity that has not been previously~     described in a Latin-american population. One hypothesis to its development is an alteration~     of the barrier function of the skin. The aim of the study is to describe the frequency of~     sensitive skin in a mexican population detected through the lactic acid test, and to explore~     its response through biophysical measures (colorimetry, transepidermal water loss (TEWL) and~     capacitance). The prevalence of this syndrome in studied populations is approximately 50%.~     Considering racial skin differences, the investigators would expect at least a 20%~     prevalence.~      For this purpose, the investigators would need a minimum of 243 healthy volunteers, 18 years~     or older, with previous informed consent, to whom the lactic acid test will be performed. The~     investigators will record any unpleasant sensation graded in a Visual Analog Scale (VAS) of~     10 points, colorimetry, TEWL and capacitance before the test and at 3, 5, 8 and 10 minutes~     after the lactic acid test.~   "
150850|NCT01591980|"~     Objective: To compare the incidence of chronic pain at 3 months among adults undergoing~     craniotomy between those received two different doses of pregabalin and those receiving~     placebo.~   "
150851|NCT01591967|"~     The purpose of this randomized controlled trial (RCT) is to measure the effects of specific~     thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both~     normotensive and hypertensive humans.~   "
150852|NCT01591954|"~     Current standard of care for complex head, neck and skull base surgery require navigation~     systems that allow instruments to be tracked optically or electromagnetically while~     registered to a patient's pre-operative X-ray computed tomography (CT) or magnetic resonance~     image (MRI). However, conventionally, the CT/MRI data is not registered with video endoscopy.~     Augmentation of endoscopic video by preoperative data can facilitate navigation around~     critical structures and robust target resection. The work presented here describes evaluation~     of a high definition (HD) video-overlay system for endonasal endoscopic skull base surgery.~     We adopt a modular design that can be extended for other video augmentation applications. The~     system supports fast automatic camera calibration, comparable in re-projection errors to~     standard camera calibration tools, while performing within appropriate run time for clinical~     use. Phantom studies have shown the registration accuracy of the system to be equivalent to~     that of conventional optical tracking. With this system we are proposing a clinical pilot~     study in a small number of patients at Johns Hopkins Hospital to evaluate basic feasibility~     and to gather qualitative assessment of the video augmentation system.~   "
150853|NCT01591941|"~     There is a large number of young women who sustain serious knee injuries from playing soccer.~     Female athletes are at high risk of knee injuries from soccer than males. We will conduct a~     research project to assess the effect of a warm-up on changing some of the movement patterns~     thought to contribute to these serious knee injuries.~      It is hypothesized that a core position and control movement strategy (Core-PAC) group reduce~     biomechanical risk factors at the knee compared to a control after the training program.~   "
150854|NCT01591928|"~     Infants with heterotaxy syndrome (HS) are born with an abnormal arrangement of organs along~     the right-left body axis. Abnormalities of intestinal rotation and fixation are commonly~     associated with HS. Malrotation is the most worrisome intestinal rotation abnormality (IRA).~     Advances in cardiac surgery have improved HS mortality such that there is increasing~     attention to IRA and their management. The objective of this research project is to~     prospectively observe a cohort of infants with HS and IRA and evaluate their long term~     outcomes. Specifically, the investigators would like to determine what is the natural history~     of asymptomatic IRA in patients with HS and what is the morbidity and mortality secondary to~     an elective Ladd procedure for asymptomatic IRA in a population with HS? The investigators~     plan a prospective, multi-center, observational study to follow this complicated group of~     patients. This will be a web-based database collected from major cardiac tertiary care~     centers in both Canada and the United States. Patients with HS will be recruited by their~     primary site and clinical data will be collected by their primary site prospectively~     throughout childhood until they are at least five years of age. This patient population will~     be followed by their own clinical care givers; this is not an interventional study. No~     additional clinic visits will be required and the patients will not have to be contacted.~     Patient medical records will be accessed by a member of the study team at the primary site at~     least once per year or more frequently if interventions are required or complications~     develop.~   "
150855|NCT01591915|"~     The purpose of this study is to evaluate the effect of mindfulness based stress reduction~     intervention in women with breast cancer~   "
173936|NCT01288404|"~     Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization~     in pterygium, preventing or retarding the progression of recurrence.~   "
150860|NCT01591850|"~     This randomized, single-center, open-label, one-sequence, two-period crossover study in three~     parts will assess the effects of multiple doses of ketoconazole, rifampicin and~     ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy~     male and female volunteers. In Period 1, subjects will receive a single oral dose of~     RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple~     oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated~     time on study is up to 8.5 weeks.~   "
150861|NCT01591837|"~     This is a study to assess the immune (antibody) response and safety of the 2012/2013~     formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or~     older.~   "
150862|NCT01591824|"~     Through this research is to conduct a pilot clinical trial in the treatment of chronic~     nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that~     will apply a technique of physiotherapy by passive movement of the column with oscillations~     in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called Pold~     Concept), another group that applies the standard protocol of treatment for this condition,~     as used in the hospital where performed the study.~      It will compare the levels of efficiency and effectiveness of each treatment and the~     comparison between them. This will measure the perception of pain intensity and disability.~   "
150863|NCT01591811|"~     1. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy~          and randomly assigned to either a weekly or a daily boost to the tumor bed develop acute~          toxicity that is not significantly worse than that of a concurrent cohort of patients~          treated with IMRT randomly assigned to a weekly or daily boost regimen.~        2. To test the hypothesis that when prone, patients treated with 3D-CRT breast~          radiotherapy, randomly assigned to either a weekly or a daily boost to the tumor bed~          develop late toxicity that is not significantly worse than that of concurrent cohort of~          patients treated with IMRT randomly assigned to a weekly of daily boost.~        3. To test hypothesis that 5 year local control rates of ≤ 5% in-breast recurrence can be~          achieved in each of the two randomized arms, for either technique tested.~   "
150864|NCT01591798|"~     After introducing minimally invasive surgery, robotic surgery has been increasingly used in~     colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of~     this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low~     rectal cancer.~   "
150865|NCT01591785|"~     Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions. In~     adults, eczema commonly localizes to the hands or feet. Several studies have implicated~     bacterial contamination, especially with Staphylococcus aureus (S. aureus), to be a factor in~     atopic dermatitis, as infection with this bacteria correlates with disease severity. No trial~     to date has investigated how to treat S. aureus infection in adults with hand or hand/foot~     dermatitis. Using retapamulin ointment in the nose and on the hands or hands/feet, the~     investigators expect to have a significant clearance rate of s. aureus infection. The~     investigators believe that treating the bacterial infection along with treating the condition~     with a topical corticosteroid will significantly decrease the severity of hand/foot~     dermatitis in our study population.~   "
150866|NCT01591772|"~     The purpose of this study is to learn about possible changes in brain anatomy and function,~     and in thinking abilities, such as memory skills, in patients with ovarian cancer who receive~     treatment with chemotherapy. Cancer patients treated with chemotherapy may experience changes~     in thinking abilities, and these may interfere with quality of life. Most of the research to~     date has involved patients with breast cancer, and there are no studies in women with ovarian~     cancer looking at at treatment-related changes in brain anatomy and function.~   "
150867|NCT01591759|"~     This investigation will explore the impact of 8 weeks of citicoline treatment on cognitive~     function, clinical state and substance use in 40 individuals with mild traumatic brain injury~     (mTBI).~   "
150868|NCT01591746|"~     Each year, the number of breast cancer survivors who choose post-mastectomy breast~     reconstruction keeps rising. Among women who elect to pursue breast reconstruction,~     approximately 75% will choose prosthetic breast reconstruction. Implant-based breast~     reconstruction is frequently achieved in two-stages. The first stage consists of the~     placement of a tissue expander after mastectomy. This is followed by a period of biweekly~     tissue expansions that can last several months. In the second stage, the tissue expander is~     removed in a surgical procedure and replaced with a permanent breast implant. Tissue~     expansion is a well-established breast reconstruction technique characterized by high success~     rates and high patient satisfaction. Despite the well-recognized advantages of this~     successful breast reconstruction technique, the subpectoral placement of a tissue expander is~     associated with significant pain and discomfort in the immediate post-operative period and~     during the phase of tissue expansion. Pectoralis major muscle spasm is a frequently reported~     problem during tissue expansion. Legeby et al. recently showed that women who underwent~     prosthetic breast reconstruction had higher pain scores and took more analgesics that those~     who did not choose post-mastectomy reconstruction.~      In the past 10 years, publications on the use of BTX-A for pain relief in a wide array of~     clinical conditions have increased tremendously. BTX-A is one of the neurotoxins produced by~     Clostridium botulinum bacteria. By reversibly inhibiting neurotransmitter release, BTX-A has~     both analgesic and paralytic properties. The analgesic action of BTX-A was initially thought~     to be related to its effects on muscular contraction. However, a recent in vitro study of~     embryonic rat dorsal neurons did confirm that BTX-A inhibits release of substance P, a~     neurotransmitter associated with pain and inflammatory reactions. The presence of analgesic~     properties of BTX-A is increasingly supported by several clinical observations: pain relief~     with BTX-A injections has been reported for migraine headaches, chronic pelvic, chronic~     tennis elbow, and post-operative pain control for lower limb lengthening correction, among~     others.~      This aspect has never been studied in breast cancer survivors who elect to pursue breast~     reconstruction with tissue expanders. Furthermore, physical function outcomes are important~     to consider with BTX-A use because the link between temporary muscle paralysis and~     improvements in participation in daily activities is not a given.~      The investigators propose to complete a double-blinded prospective randomized controlled~     trial of women undergoing unilateral and bilateral mastectomies with immediate placement of~     tissue expanders, to establish the efficacy and safety of BTX-A in alleviating pain and in~     improving physical well-being during the expansion period.~   "
150882|NCT01591564|"~     The purpose of this study is to determine the feasibility and acceptability of an utilizing~     an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for~     Depressed Adolescents, for youth with severe mood dysregulation (SMD).~      The investigators hypothesize that retention rates will be >80%,satisfaction scores will~     average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD~     intervention will have overall improvement in SMD symptoms.~   "
150883|NCT01591551|"~     The purpose of this study is to assess the impact of Natalizumab (Tysabri) therapy on sleep~     efficiency, total sleep time and sleep latency, in Multiple Sclerosis (MS) patients receiving~     Natalizumab for 6 months relative to baseline.~   "
150884|NCT01591538|"~     Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative~     bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6~     months outside France.~   "
150869|NCT01591733|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of a therapy to learn whether the therapy works in treating a specific cancer.~     Investigational means that the therapy is still being studied and that research doctors are~     trying to find out more about it-such as the safest dose to use, the side effects it may~     cause, and if therapy is effective for treating different types of cancer. Proton beam~     radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery~     system.~      Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as~     it delivers less radiation beyond the area of the target tissues. This may reduce side~     effects that patients would normally experience with standard (photon) radiation therapy,~     which tends to include more normal tissue along with tumor target tissue.~      Researchers in the laboratory have discovered that there are pathways inside the cells that~     can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and~     capecitabine are targeted towards blocking the pathways that allow cancer cells to divide,~     and may result in the tumor shrinking in size.~      In this research study, the investigators are looking to determine if proton beam radiation~     in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of~     your cancer.~   "
150870|NCT01591720|"~     A tailored Internet-based cognitive-behavioural intervention is tested within a primary care~     clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant~     within-group effects are expected.~   "
150871|NCT01591707|"~     The purpose of this study is to test the effectiveness of a school-based treatment aimed at~     increasing language and social skills in preschool-aged children with autism spectrum~     disorder (ASD). Through interactive development (continually seeking educator feedback for~     intervention improvement) and implementation of the intervention, the investigators hope to~     provide a feasible and practical means for educators to work with children with ASD in real~     world, large scale settings. ASD preschool educators, the children enrolled in their classes,~     between the ages of 3 and 6 years and their families may join.~   "
150872|NCT01591694|"~     Trauma-informed treatment will improve emotional regulation and behavior.~   "
150873|NCT01591681|"~     The purpose of this study is to see whether low blood sugar at night can be reduced by using~     a system that turns off the insulin pump automatically. The study system includes a~     combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and~     a regular laptop computer that runs a computer program that predicts low blood sugar. It~     works by (1) measuring the glucose levels under the skin with a continuous glucose monitor,~     (2) using a computer program on a laptop to predict what will happen to the glucose level~     over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program~     predicts that low blood sugar will occur.~      This study has several phases and will take about 3 months for a patient to complete.~     Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure~     that they are able and willing to use this system and to determine if they meet the~     investigators study criteria to proceed with the next phase of the study. Patients will be~     provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic~     CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is~     able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most~     recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to~     complete the CGM run-in phase will have an extra office visit for training.~      If eligible to continue in the study, patients will need to use the study system for 5 nights~     at home so that the investigators can make sure they are able to use it correctly. After~     that, patients will be asked to use the study system each night for an additional 6 to 8~     weeks. If the system is active and predicts that a patient's blood sugar will become low, the~     insulin pump will shut off for up to 2 hours.~      The study will include about 45 individuals at 3 clinical centers in the United States and~     Canada.~   "
150874|NCT01591668|"~     Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2~     mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and~     activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up~     visits are also required periodically through day 43. Study procedures involve taking blood~     samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.~   "
150875|NCT01591655|"~     The objective of this clinical study is to compare the safety and efficacy of mapracorat~     ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation~     and pain following cataract surgery. Participants from the United States and Canada will be~     recruited for this study.~   "
150876|NCT01591642|"~     The main purposes of this study are: (1) to investigate the difference of the physical~     fitness, and quality of life (QOL) among different physical activity levels in post-coronary~     artery bypass graft (CABG) patients; (2) to analyze the relationships between physical~     activity and physical fitness and QOL in this population. The investigators predict physical~     activity and physical fitness remain limited in patients after CABG, and patients with higher~     physical activity levels will have higher QOL and physical fitness.~   "
150877|NCT01591629|"~     The purpose of this project is to examine the effects of mu-opiate antagonism on the~     rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main~     psychoactive ingredient of cannabis.~   "
150878|NCT01591616|"~     To establish Oraqix is safe when used on adolescent volunteers.~   "
150879|NCT01591603|"~     The study will investigate the difference in success rate between popliteal peripheral nerve~     catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.~   "
150880|NCT01591590|"~     The purpose of this study is to assess whether in a population of patients with advanced~     colorectal cancer for which no known effective therapy is available, measuring the~     spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and~     Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that~     serial FDG PET-CT and Diffusion MRI are able to measure it.~   "
150881|NCT01591577|"~     The purpose of this study is to test the safety and effects of a combination of a study drug,~     Lapatinib, plus the administration of standard radiation therapy and an FDA approved drug~     Temozolomide (chemotherapy agent) in patients with newly diagnozed glioblastoma~     Multiforme.Currently, only radiation therapy and Temozolomide chemotherapy are standard~     treatment for brain cancer.Lapatinib has not been FDA approved for use in brain tumors~     treatment. It has been approved to be used as a daily treatment with other chemotherapies by~     the FDA for the treatment of advanced breast cancer.~      The purpose of this study is to find the answers to the following research questions:~        1. Is Lapatinib given twice a week at higher dosages, with radiation therapy and~          Temozolomide, safe when given to patients with brain tumor?~        2. What are the side effects of Lapatinib given twice a week at higher dosages when given~          with radiation therapy and Temozolomide and how often do they occur?~        3. Can Lapatinib, radiation, and Temozolomide be effective in shrinking tumors when given~          to patients with brain tumors?~        4. To determine whether the presence of genetic alterations specific proteins in the tumor~          samples can predict whether this study drug is effective on the tumor.~   "
150885|NCT01591525|"~     The purpose of the type II diabetes (T2D) screening study is to improve diabetes care in~     minority communities by identifying undiagnosed and uncontrolled T2D patients, as well as~     help patients without a regular primary care physician (PCP) find one within their community.~     These goals will be achieved first through a glucose measurement. Individuals with a high~     glucose measurement will be confirmed with a rapid hemoglobin A1c (HgA1c) test. The HgA1c~     test will tell us about the patients average blood sugar over the past 3 months, which will~     allow us to immediately diagnose new and uncontrolled type II diabetics. All participants~     will fill out a survey on healthcare seeking behaviors before glucose testing. All patients~     who enter the study will receive education on T2D and the value of regularly visiting their~     PCP, and will be provided a list of PCP currently accepting new patients within a 3 mile~     radius. Follow-up visits at 4 and 8 months will help us determine the success this community~     based screening.~      The investigators hypothesis is that community based screening designed with adequate~     education and follow-up, and performed by qualified medical professionals will improve~     diabetes care in minority communities as assessed through hemoglobin A1c levels over 8~     months, and in the change in the number patients who visit/obtain their PCP within the study~     period.~   "
150886|NCT01591512|"~     The purpose of this study is to collect samples to evaluate the ProGRP and NSE assays~     independently as aids for monitoring the course of disease and therapy in subjects diagnosed~     with SCLC.~   "
150887|NCT01591499|"~     This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare~     the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses~     allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a~     ratio of 1/0.5), in presbyopic patients.~   "
150888|NCT01591486|"~     Low-dose aspirin (ASA) has emerged as the most important cause of peptic ulcer bleeding~     worldwide. In western countries, ASA has overtaken non steroidal antiinflammatory drugs~     (NSAIDs) as a major cause of peptic ulcer bleeding in the elderly population [1,2].~     Management of peptic ulcer bleeding in patients receiving ASA for cardiothrombotic diseases~     is a clinical dilemma. In a randomized trial of continuous versus interrupted ASA therapy~     after endoscopic treatment of peptic ulcer bleeding, patients who discontinued ASA had a~     10-fold increased incidence of all-cause mortality compared to those who received continuous~     ASA therapy. On the other hand, patients receiving continuous ASA therapy had a two-fold~     increased risk of early rebleeding [3]. Thus, preventing the occurrence of peptic ulcer~     bleeding in ASA users is important in reducing morbidity and mortality.~      Given the uncertain clinical utility of Helicobacter Pylori (Hp) testing in ASA users, this~     prospective cohort study aims to determine whether testing for Hp will have any impact on the~     long-term incidence of ulcer bleeding in ASA users with high ulcer risk. The investigators~     hypothesize that among ASA users with Hp infection and ulcer bleeding, the long-term~     incidence of recurrent ulcer bleeding with ASA use will be low after eradication of Hp alone.~   "
150889|NCT01591473|"~     The purpose of this study is to evaluate FluMist with and without Ampligen in healthy~     volunteers.~   "
150890|NCT01591460|"~     This open-label, multicenter, treatment response guided study will evaluate the sustained~     virological response and safety of the triple combination therapy boceprevir, Pegasys~     (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with~     genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual~     combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination~     therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be~     administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment~     response. The anticipated time on study treatment is up to 48 weeks.~   "
150891|NCT01591447|"~     To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the~     treatment of uncomplicated urogenital gonorrhea.~   "
150892|NCT01591434|"~     Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such~     it is anticipated that through improved exudate management a longer wear time will be~     achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic~     wounds such as venous leg ulcers.~   "
150893|NCT01591421|"~     For the first phase of this study (phase I), the purpose will be to find the dose of a new~     drug, BKM120, that can safely be given in combination with standard dose panitumumab.~      For the second phase of this study (phase II), the purpose is to find out what effects the~     combination of BKM120 and panitumumab, in doses found to be safe in the first part of the~     study, has on patients and their colorectal cancer.~   "
150894|NCT01591408|"~     The proposed study, Placebo-controlled study of EEG biofeedback therapy as an adjunct~     treatment for PTSD, evaluating symptoms and EEG dynamics, will investigate the brain~     dynamics associated with PTSD symptom reduction associated with EEG biofeedback therapy or~     sham EEG biofeedback in addition to treatment as usual at the Naval Medical Center, San Diego~     (NMCSD) OASIS program.~      EEG biofeedback treatment protocols for PTSD and other disorders have been developed and~     honed by private practice clinicians over the past 25 years, during which EEG biofeedback has~     become an increasingly popular adjunct therapy.~      The reported success of EEG biofeedback as a non-drug intervention with lasting efficacy~     warrants a clinical study investigating not only symptom reduction, but also the underlying~     neurobiological mechanism. To this end, we propose a study using high density EEG recordings~     before and after treatment for PTSD symptoms to determine which brain activities correlate~     with reported symptom changes.~      The proposed study could expand treatment alternatives for servicemen with PTSD. If EEG~     biofeedback is shown to improve symptom reduction over the placebo controlled condition, it~     would offer a non-pharmacological intervention that would avoid undesirable side effects, and~     accelerate recovery compared with the current standard of care.~   "
150917|NCT01591096|"~     Thrombolysis in Pediatric Stroke (TIPS) is a five-year multi-center international safety and~     dose-finding study of intravenous (IV) tPA in children with acute ischemic stroke (AIS) to~     determine the maximal safe dose of intravenous Tissue Plasminogen Activator (IV-tPA) among~     three doses (0.75. 0.9, 1.0 mg/kg) for children age 2-17 years within 4.5 hours from onset of~     acute AIS.~   "
151046|NCT01589406|"~     Patients with premalignant (CIN3) and malignant cervical cancer will asked to complete~     questionnaires regarding intimacy (ENRICH) and life adaptation (PAIS) before treatment~     (surgery or radiotherapy) and after completion of treatment in order to estimate the~     influence of disease and treatment on quality of life indices.~   "
150895|NCT01591395|"~     Inguinal hernia is one of the most common surgical diseases. Over the past years, the safety~     and feasibility of laparoscopy was established and gaining popularity in recent few years.~     Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter~     recovery period, earlier return to normal daily activities and work, and better cosmetic~     results. The laparoscopic hernia repair usually require three working ports ranging from 5 to~     10 mm. However, with each increasing laparoscopic ports usually associated with possible~     increasing morbidity and pain related to ports.~      Efforts are continuing to further reduce the port related morbidities and improve the~     cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of~     ports. This has led to the evolution of a novel surgical approach now collectively known as~     laparoendoscopic single site surgery. LESS has been performed for variable indications~     including extirpative and reconstructive urologic procedure via the transperitoneal approach.~     Early experience has demonstrated the feasibility as well as the safe and successful~     completion of these LESS procedures. Although these initial reports are promising, the~     clinical advantages of LESS procedures over conventional laparoscopic procedures have not~     been defined. Therefore, we conducted a single center, randomized trial to compare the safety~     and other outcomes after conventional laparoscopic and LESS inguinal hernia repair in adult~     patients.~   "
150896|NCT01591382|"~     Patients who are dependent on opioids often have poor pain relief after major surgery. This~     study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of~     intravenous opioids for postoperative pain will improve pain relief in this subset of~     patients.~   "
150897|NCT01591356|"~     The goal of this clinical research study is to learn about the safety of siRNA-EphA2-DOPC~     when given to patients with advanced, recurrent cancer. Researchers also want to learn the~     highest tolerable dose of this drug that can be given.~      siRNA-EphA2-DOPC is designed to shut down the activity of a genetic biomarker called EphA2.~     Biomarkers are found in the blood and tissue and may be related to your reaction to the study~     drug.~      You are being asked to take part in this study because you have advanced cancer that is~     recurrent (has come back).~      This is an investigational study. siRNA-EphA2-DOPC is not FDA approved or commercially~     available. It is currently being used for research purposes only.~      Up to 40 patients will be enrolled on this study. All will be enrolled at MD Anderson.~   "
150898|NCT01591343|"~     Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides~     pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or~     rhinoconjunctivitis with or without asthma.~      Primary variable: number of subjects [%] who experienced at least one immediate or delayed~     systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.~   "
150899|NCT01591330|"~     The study will evaluate the effect of different particle size of LY2140023. The study~     involves four single doses of 80 mg LY2140023 taken as 1 tablet by mouth with a washout~     period of at least 3 days between doses. This study will last approximately 60 days not~     including screening. Screening is required within 30 days prior to study entry.~   "
150900|NCT01591317|"~     The purpose of this study is to investigate how the body processes prasugrel and how~     prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of~     prasugrel will be given. Information on side effects will also be collected.~   "
150901|NCT01591304|"~     This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.~   "
150902|NCT01591291|"~     Heavy drinking can cause serious health, family, and economic problems. Finding treatments~     that are effective in decreasing heavy drinking among alcohol-dependent individuals is,~     therefore, an important scientific and health goal. A novel and important strategy to enhance~     alcoholism treatment efforts uses a personalized medicine approach to optimize treatment~     effects by selecting the right patient therapeutically and potentially with a minimum of~     adverse events, for a specific medication.~      This study will extend findings from a randomized double-blind clinical trial of ondansetron,~     in which the medication was found to reduce drinking among individuals with certain genotypes~     (i.e., forms of DNA, the material that controls the inheritance of characteristics). The~     proposed study will address a number of limitations in the prior work, including testing the~     medication in both European-American and African-American samples.~   "
150903|NCT01591278|"~     The objective of the study is to evaluate and compare, clinically and radiographically,the~     effects of MTA and Biodentine when used as pulp dressings following pulpotomy in human~     primary molars.~   "
150904|NCT01591265|"~     This clinical trial investigates relative benefits (clinical effectiveness and quality of~     life) of two extraction patterns when lower first permanent molars (FPM) are extracted in~     children: the conventional treatment where current guidance is followed and extraction of the~     upper FPM is carried out, compared with the intervention where there is no compensation~     extraction of the upper FPM following extraction of the lower FPM.~      Study objectives: To determine whether compensating extraction of upper FPMs following loss~     of lower FPMs in children is of benefit. The particular benefits being investigated are~     related to the resulting occlusion, patient experience and oral health related quality of~     life. The follow up will extend over a period of 5 years or until the patient is 14 years of~     age - whichever is earlier.~   "
150905|NCT01591252|"~     In a group of HIV-positive patients under observation since their first exposure to ART or~     monitored off of ART, BMD changes over one year will be determined. For each subject, the~     investigators will also determine associations between changes in BMD and 1) ART initiation,~     2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated~     through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a},~     high-sensitivity c-reactive protein {hsCRP}).~      Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of~     ART, after excluding those subjects treated with tenofovir.~      BMD will decrease most significantly in HIV-positive subjects with the highest levels of~     cumulative viremia.~      HIV-positive persons with highest cumulative viremia will have the highest levels of~     inflammation, as measured by pro-inflammatory cytokines.~      Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare~     sample and fracture association with the use of varying ART medications among dual-eligible~     persons in Medicare and Medicaid datasets.~      Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to~     HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest~     duration of ART exposure.~   "
150906|NCT01591239|"~     This project is aimed at parents with a teenager who is already starting to use drugs. The~     study will test a new, innovative version of a brief intervention. This program will be home~     based rather than implemented by a counselor in a clinical setting. The stage I activities~     will involve manual development, parent training development, and a small feasibility study;~     Stage II involves an efficacy study. Two samples, 110 families each, will participate in the~     trial. Families will be assigned to either an intervention or control condition. The~     investigators hypothesize that the home-based intervention will be superior to the control~     condition. In addition, the investigators expect response to the intervention by the~     adolescent to be mediated by motivation, cognitions, problem solving, peer drug use,~     parenting skills and parent self-efficacy.~   "
150907|NCT01591226|"~     A positive ergogenic effect of sodium citrate and caffeine ingestion in a short-term,~     high-intensity exercise task was shown by several studies. These studies were conducted with~     healthy, able-bodied subjects.~      The aim of the study is to investigate whether caffeine or sodium citrate ingestion could~     enhance performance in spinal cord injured wheelchair athletes. It is a double blind, placebo~     controlled and randomized study.~   "
150908|NCT01591213|"~     -The St. Jude Cancer Education for Children Program was created in 2006 as part of the~     outreach mandate of the Comprehensive Cancer Center at St. Jude Children's Research Hospital.~     The curriculum is designed to teach schoolchildren about cancer and dispel common~     misconceptions, inform students about healthy lifestyle choices that can translate to reduced~     cancer risk in adulthood, and to inspire an interest in science and scientific careers. In~     the 2010-2011 school year, researchers examined the impact of the program in regard to~     knowledge.~      It has always been clear that St. Jude personnel are limited to visiting a small number of~     schools in person each year so in 2011, a teacher's kit to the education program was created.~     The kit includes all the lesson plans needed to complete the program without the presence of~     St. Jude staff members. As a result, researchers at St. Jude Children's Research Hospital~     want to test the feasibility of the intervention by schoolteachers, and how this mechanism of~     delivery will affect student knowledge, attitudes, and health behaviors associated with~     cancer and healthy living.~   "
150909|NCT01591200|"~     This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with~     cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in~     various parameters will be observed over 2 years.~   "
150910|NCT01591187|"~     Exposure to secondhand smoke is a leading preventable cause of child morbidity and mortality,~     and the adverse health consequences of secondhand smoke are magnified among youngsters with~     cancer and sickle cell disease. Current methods for measuring secondhand smoke exposure~     (SHSe) rely on retrospective reports over extended time periods that are subject to recall~     errors and systematic inaccuracies in reporting and often do not include the youngster as the~     primary informant. These methods may underestimate the extent of cumulative SHSe and are not~     well suited to capturing exposure over time and across settings where young people frequent.~     More appealing methods that engage youngsters to better monitor tobacco smoke in their~     environment are warranted.~      The study will examine the feasibility of cell phone texting to obtain measures of secondhand~     smoke exposure (SHSe) in children treated for cancer or sickle cell disease (SCD).~   "
150911|NCT01591174|"~     The purpose of this research is to see if there are differences between children who have FD~     and children without FD in the ability of the stomach to empty food and/or in ghrelin hormone~     levels before and after eating.~      Chronic abdominal pain is the most common persistent pain condition in children and~     adolescents. One of the most often diagnosed types of abdominal pain is functional dyspepsia~     (FD). FD is abdominal pain or discomfort (e.g., nausea, bloating) in the upper abdomen that~     does not get better by having a bowel movement.~      One possible explanation for having FD is a delay in the emptying of food from the stomach,~     or delayed gastric (stomach) emptying. Failing to empty the stomach quickly enough may result~     in the feeling of being full and cause symptoms of bloating, nausea, vomiting and pain.~     Further, hormonal changes occur before, during, or after eating food that appear to impact~     stomach emptying.~      One of the hormones that changes with meals is called ghrelin. The relationship between~     ghrelin and stomach emptying needs to be explored more in children with FD. Better~     understanding of what causes FD symptoms may help us to improve treatment for this condition.~   "
150912|NCT01591161|"~     The objective of this clinical study is to compare the safety and efficacy of mapracorat~     ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation~     and pain following cataract surgery.~   "
150913|NCT01591148|"~     This study will determine how morbid obesity affects the distribution and metabolism of the~     drug propofol. The investigators hypothesize that propofol will be distributed and~     metabolized differently in morbidly obese subjects as compared to normal weight subjects.~   "
150914|NCT01591135|"~     The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has~     better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients~     with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into~     this study.~   "
150915|NCT01591122|"~     The purpose of this study is to demonstrate the safety and effectiveness of abiraterone~     acetate when co-administered with prednisone in patients with chemo-naive metastatic~     castration resistant prostate Cancer (mCRPC).~   "
150916|NCT01591109|"~     Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the~     effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with~     metastatic liver tumors derived from colorectal cancer.~      Background Data: Direct evidence on the reversibility of any change in tumor vascularity upon~     bevacizumab cessation in the clinical setting is lacking.~      Methods: The study included 10 patients who received chemotherapy including bevacizumab,~     experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently~     underwent liver resection. CEUS was performed before and immediately after 4 courses of~     chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34~     antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD). As~     a control, 10 surgical specimens from 10 patients who had not received chemotherapy were~     examined.~   "
152561|NCT01569438|"~     The purpose of this study is to assess the efficacy of a single dose level of gefapixant~     (AF-219/MK-7264) in female subjects with moderate to severe pain associated with interstitial~     cystitis/bladder pain syndrome (IC/BPS) after 4 weeks of treatment.~   "
150918|NCT01591083|"~     Patients with comorbidities have an increased risk of ulcer re-bleeding, especially within~     the 14 days after first bleeding event. Three-day high dose esomeprazole infusion can prevent~     peptic ulcer rebleeding after endoscopic therapy. However, the optimal dose of oral~     esomeprazole is uncertain, especially for high risky patients. This study is to test whether~     a double dose of oral esomprazole could reduce peptic ulcer rebleeding for patients with~     Rockall score ≥ 6. Additionally, the second aim of this prospective study was to identify the~     selection criteria to predict poor fading and residual major stigmata of recent hemorrhage~     (SRH) or early recurrent bleeding after successful endoscopic hemostasis and high-dose PPI~     infusion.~   "
150919|NCT01591070|"~     The purpose of this study is to determine whether proactive use of 0.1% tacrolimus ointment~     once or twice weekly can keep adult facial SD in remission and reduce the incidence of~     exacerbation.~   "
150920|NCT01591057|"~     This study will examine what contribution of 'markers' of fruit and vegetable (FV) intake in~     blood and urine is most closely related to FV intake. 30 healthy volunteers will be fed~     either 2, 5 or 8 portions of FV per day for 4 weeks (ten participants per group, randomly~     assigned). Volunteers will have all their food provided during the study, and will consume~     two meals each weekday at the University. Volunteers will complete diet and lifestyle~     questionnaires at the start and end of the study and will have blood and urine samples~     collected at 0, 2 and 4 weeks.~   "
150921|NCT01591044|"~     The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in~     the treatment of mild to moderate asthma.~   "
150922|NCT01591031|"~     Anesthesia induction with sevoflurane is not associated with an increased incidence or~     severity of laryngeal injuries compared with an anesthesia induction with a muscle relaxant.~   "
150923|NCT01591018|"~     The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual~     transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of~     brain infarctions due to the activation of endogenous fibrinolytic system during cardiac~     surgery (CS). 120 patients indicated for CS (CABG or valve replacement) will be enrolled into~     the study in order to demonstrate a twenty-percent risk reduction of number and volume of~     brain infarctions detected using MRI examination 24 hours after CEA or CS in 5% level of~     significance. Patients will be randomized - subgroup 1 will undergo a 40-240minute~     non-diagnostic TCD monitoring during CS, subgroup 2 will undergo interventions without TCD~     monitoring.~      The aim of the project is a concordance with the aim No 1 of the Resort Program of a Research~     and Development: Improvement of quality of life of patients using the modern therapeutic~     methods but with relative small positive effect of quality of life. The aim of the project~     is in concordance with a priority of announced public grant competition: Development of the~     new therapeutic methods of cardiovascular disorders, especially coronary heart disease and~     stroke. Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous~     fibrinolytic system during CS with consecutive reduction of the number and volume of brain~     infarcts, can lead to the increase of the safety of CS in patients. We can presume that up to~     50% of patients indicated for CS can be treated using these methods in the future.~   "
150924|NCT01591005|"~     The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual~     transcranial Doppler monitoring) using 2 MegaHertz (MHz) diagnostic probe on the reduction of~     risk of brain infarctions due to the activation of endogenous fibrinolytic system during~     carotid endarterectomy (CEA) and carotid stenting (CS). 240 patients indicated for CEA (120~     patients) and CS (120 patients) will be enrolled into the study in order to demonstrate a~     twenty-percent risk reduction of number and volume of brain infarctions detected using MRI~     examination 24 hours after CEA or CS in 5% level of significance. Patients will be randomized~     - subgroup 1 will undergo a 60minute non-diagnostic transcranial Doppler (TCD) monitoring~     during CEA or CS, subgroup 2 will undergo interventions without TCD monitoring. The second~     aim is to compare number of brain infarctions detected using MRI between CEA and CS patients.~      Confirmation of the investigators hypothesis that sonothrombolysis is able to activate~     endogenous fibrinolytic system during CEA or CS with consecutive reduction of the number and~     volume of brain infarcts, can lead to the increase of the safety of CEA and CS in patients~     with internal carotid artery stenosis. The investigators can presume that up to 50% of~     patients indicated for CEA or CS can be treated using these methods in the future.~      In the Substudy Risk of brain infarction after carotid endarterectomy and stenting the the~     risk of asymptomatic and symptomatic brain infarctions, changes in cognitive functions, as~     well as morbidity and mortality at 30 days between patients with symptomatic and asymptomatic~     severe internal carotid artery (ICA) stenoses undergoing elective CEA and CAS will be~     compared.~      The sample size of the Substudy was based on an expected 80% difference of new ischemic~     lesions on DWI-MRI between CEA (estimated prevalence, 30%) and CAS (54%). Pre-study~     calculations showed that a minimum of 73 patients in each group was needed to reach a~     significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8~     assuming that 15% of subjects would be lost to follow-up or refuse to participate in the~     study.~   "
150925|NCT01590992|"~     The purpose of this study is to determine whether psychotherapy (based on exposure~     techniques) is effective in the treatment of functional somatic symptoms (FSS)/Somatoform~     Disorders (as exemplified here in subjects with globus sensations in the throat).~   "
150926|NCT01590979|"~     The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset~     atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient~     population at Staten Island University hospital.~   "
150927|NCT01590966|"~     In this open-label monocentric explorative pilot trial the objective is to show the~     biodistribution of TNFα by administration of radiolabeled anti-TNFα in patients with active~     rheumatoid arthritis and spondylarthropathy. The anti-TNFα used in this trial is certolizumab~     pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high specificity for~     TNFα. Certolizumab pegol will be radiolabeled with 99mTechnetium. The aim of this study is to~     show the TNFα triggered inflammation process in the inflamed joints, especially in patients~     who have very early joint damage where currently other imaging methods such as X-rays are not~     sensitive enough for detection.~   "
150928|NCT01590953|"~     Ochsner employees with a body mass index (BMI) greater than or equal to 30 will be enrolled~     in a fitness program consisting 90 days of a structured exercise program and dietary~     counseling. Measures of fitness including weight, BMI, cholesterol, HDL, blood pressure, and~     absenteeism rates will be measured at 0, 90 days, in one year.~   "
150948|NCT01590693|"~     The purpose of this study is to determine whether botulinum toxin A (BTX) adds a favourable~     effect to treatment of idiopathic toe-walking with below knee walking casts. The specific~     hypothesis to be tested is that a combination of BTX and casting is more effective than~     casting treatment alone in reducing toe-walking in 5-15 year old children. Evaluation methods~     include 3-D gait analysis, parents' perception of toe-walking frequency, passive joint range~     of motion measurements, and strength of ankle dorsal extension.~   "
155412|NCT01531972|"~     This is an open-label study investigating the relationship between SEP-228432 and SEP-228431~     (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT~     occupancy, both measured by SPECT imaging.~   "
150929|NCT01590940|"~     The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic variability~     in the number and composition of meshes currently on the world market. The use of~     biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. These~     selected polymers have the ability to degrade while implanted, allowing for sufficient~     natural tissue healing and scarring. This usage presumably favors a decrease in foreignness,~     inflammatory reaction, recurrence, and incidence of chronic groin pain. Prior studies with~     similar plug meshes in the same indication have yielded favorable results which require this~     mesh to be investigated in its specific application.~      Primary Objective~      Evaluate the incidence of peri-operative and post-operative complications after the~     application of the Parietex plug and patch hernia system in open inguinal hernia repair. We~     will assess the efficacy of this mesh by examination and the application of a pain scale at~     the following intervals: 1 month, 3 months, and 1 year, respectively. Assessment is intended~     to evaluate:~        -  Patient report of pain via their Pain score~        -  Wound complication~        -  Incidence of chronic groin pain~        -  Recurrence rate~        -  Other complications Secondary Objectives~      Record the description and assessment of the Parietex plug and patch hernia system:~        -  surgical technique~        -  description of dissection and mesh placement~        -  method of fixation~        -  operative times, anesthesia choice~        -  length of hospital stay~        -  mesh handling characteristics~        -  return to daily activities~        -  overall patient satisfaction~   "
150930|NCT01590927|"~     Now a days the ultrasound is seen as a valid and reliable measurement tool to test the Pelvic~     Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, & Galea, 2005). The hypothesis~     is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM movement in an~     equal or even more precise way. The TrakSTARTM will have the advantage to be used in~     measuring functional movements. In this Master thesis the hypothesis is to show a good~     reliability by trampoline jumping (physical activity).~   "
150931|NCT01590914|"~     Utilizing fMRI, this study will examine changes in BOLD signal as a proxy measure of brain~     activation in response to highly palatable (high energy density [kcal/g]), less palatable and~     non-food stimuli in severely obese women pre, 1 month post and 3 months post undergoing~     bariatric surgery (in surgery patients) and at equivalent times for control groups in fed and~     fasted conditions at each time point.~      Two surgical groups: (i) laparoscopic Roux-en-Y gastric bypass (RYGB) and (ii) gastric~     banding (GB) will be compared with two control groups: (i)those enrolled on a 3-month formula~     weight loss program or (ii) those who qualify, but do not undergo bariatric surgery, and~     receive no weight loss treatment.~   "
150932|NCT01590901|"~     The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral~     doses of probucol in healthy male subjects.~   "
150933|NCT01590888|"~     Huntington disease (HD) is an inherited neurodegenerative disease which affects over 30,000~     people in both the United States and Australia. HD is characterized by brain cell death that~     usually begins between the ages of 30 to 50, and results in motor, cognitive and behavioral~     signs and symptoms. While there are medications to help relieve some of the disease symptoms,~     there is no known treatment to address the cognitive impairment associated with HD.~      Normally occurring metals in the brain play a significant role in diseases such as Alzheimer~     disease and HD. PBT2 is a drug designed to interrupt interactions between these biological~     metals and target proteins in the brain, to prevent deterioration of brain cells. PBT2, has~     shown in animal models, and as well as in a small group of patients with Alzheimer's disease,~     it may improve cognition. There is some indication in animal models of HD, that the drug may~     improve motor function and control and reduce the amount of brain cell degeneration.~      PBT2-203 will evaluate how safe and well tolerated PBT2 is at a dose of 100 mg or 250 mg a~     day administered as oral daily capsules compared to a placebo over a six month treatment~     period. The trial will also measure whether there is an effect on cognitive abilities as well~     as other HD symptoms including motor and overall functioning of individuals with HD.~   "
150934|NCT01590875|"~     Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins~     during atrial fibrillation ablation, however, the methodology has not been validated either~     in terms of the reproducibility of the adenosine response or the effect on clinical outcomes,~     namely whether using pulmonary vein reconnection to guide additional ablation lowers rate~     recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response~     to adenosine used in this manner is reproducible over time.~   "
150935|NCT01590862|"~     The primary aim of this study is to test the effects of excitation of ventral striatal~     circuitry via DBS (e.g. DBS-on versus DBS-off) on reward motivation. The investigators~     predict that stimulation will increase subject willingness to expend effort for rewards and~     facilitate motivation for reward learning. The investigators further predict that individual~     differences in the effects of DBS on reward motivation as will be associated with effects of~     DBS treatment on anhedonic symptoms.~   "
150936|NCT01590849|"~     The use of combined oral contraceptives has been associated with increased risk of adverse~     cardiovascular events. The exact mechanism by which these drugs exert this influence is~     uncertain. It is possible that changes in autonomic nervous system are involved. The~     objective of these study was to evaluate the effect of the use of a contraceptive containing~     20 mcg of ethinyl estradiol and 3mg of drospirenone in the autonomic nervous system in~     healthy women. Few studies have been conducted in the field of hormonal contraception and~     evaluation of the autonomic nervous system work and no prospective, controlled study was~     published so far. These study will be the first.~   "
150937|NCT01590836|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamic response (the effect of the investigated drug on the body) of insulin~     degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.~   "
150949|NCT01590680|"~     Primary Objectives:~        -  Provide palliative therapy with 131I-MIBG for patients with advanced neuroblastoma,~          pheochromocytoma, or paraganglioma.~        -  Gain more information about acute and late toxicity of 131I-MIBG therapy for patients~          with refractory neuroblastoma, pheochromocytoma, or paraganglioma.~   "
150950|NCT01590667|"~     The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy~     subjects, to provide more comprehensive and robust clinical evidence in its mode of action~     for the treatment of obesity and weight management through dietary fat binding.~   "
150938|NCT01590823|"~     Patients with end stage renal disease carry a high risk for atrial fibrillation (AF) and~     require oral anticoagulant therapy for prevention of stroke. Often, the oral anticoagulant,~     warfarin sodium, is prescribed. Managing dialysis patients on warfarin can be fraught will~     difficulties given the multitude of drug and food interactions, need for frequent coagulation~     monitoring and dosage adjustment, and concern that warfarin enhances vascular calcification~     in dialysis patients. Recently, dabigatran etexilate, a direct oral thrombin inhibitor, has~     been approved for use in AF patients with normal renal function. Since many drugs are~     eliminated by the kidneys and removed from the plasma during dialysis, it is important to~     determine proper drug dosing in hemodialysis patients through evaluating pharmacokinetics.~   "
150939|NCT01590810|"~     This study will evaluate the safety and tolerability of MK-8150 and its effect on central~     systolic blood pressure (cSBP) and heart rate corrected augmentation index (AIx) when given~     as single oral doses in healthy males and in males with mild-to-moderate hypertension. A~     primary study hypothesis is that post dose mean change from baseline of time-weighted average~     across 24 hours (TWA0-24hrs) cSBP or AIx is reduced in participants administered MK-8150~     compared to placebo in males with mild to moderate hypertension. A mean decrease from~     baseline compared to placebo of ≥5 mm Hg in TWA0-24hrs cSBP or of ≥5 percentage points in~     TWA0-24hrs AIx is considered clinically meaningful.~   "
150940|NCT01590797|"~     A study to compare safety and efficacy of sitagliptin and placebo therapy when added to~     stable insulin alone or in combination with metformin in participants with type 2 diabetes~     mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of~     sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in~     T2DM participants on insulin alone or in combination with metformin.~   "
150941|NCT01590784|"~     Depression in patients with schizophrenia is common. Several factors was found to be~     associated with depression including medical illness, quality of life, positive symptoms, and~     typical antipsychotics. The Calgary depression scale of schizophrenia (CDSS) is commonly used~     for screening depression in schizophrenia,however; the Thai version of CDSS has not been~     validated.~      This study aims to a.) test the reliability and validity of the Thai version of Calgary~     depression scale of schizophrenia (CDSS) and b.) identify the prevalence and factors~     associated with depression in patients with schizophrenia including quality of life, type of~     antipsychotic drugs, and severity of schizophrenia in 60 patients with schizophrenia at the~     Faculty of Medicine, Chiang Mai University, Thailand.~   "
150942|NCT01590771|"~     A study to compare safety and efficacy of sitagliptin and placebo therapy when added to~     stable sulfonylurea alone or in combination with metformin in participants with type 2~     diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the~     addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C~     (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.~   "
150943|NCT01590758|"~     The purpose of this study is to establish the clinical superiority and the safety of topical~     pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus~     standard local wound care, in the treatment of mildly infected diabetic foot ulcers.~   "
150944|NCT01590745|"~     Carpal Tunnel Syndrome (CTS) is a recognisable pattern of symptoms and signs, which are~     caused by compression of the median (middle) nerve as it passes through the carpal tunnel at~     the wrist.~      This condition affects individuals by causing pain, numbness, tingling sensations and~     sometimes weakness in the fingers and may extend to shoulder and neck areas. The cause for~     most cases is unknown (idiopathic) though some common conditions are associated with an~     increased incidence, including obesity, pregnancy, hypothyroidism, arthritis, diabetes, and~     trauma.~      Diagnosis is primarily clinical and the condition is easily recognised from the~     characteristic symptoms in straightforward cases but diagnostic support is provided by~     investigations such as nerve conduction studies and ultrasound imaging.~      Treatment may include splinting, local steroid injection at wrist, activity~     modification,physical or occupational therapy (controversial), medications, and surgery.~     Treatment with local therapeutic ultrasound has been suggested to be effective but existing~     trials are inconclusive.~      Wrist splinting is only partially effective with a success rate of 34%, Steroid injection is~     followed by frequent relapses and there remains uncertainty about the safety of serial~     injections. Surgery is effective but has a small but significant incidence of permanent~     complications. Any demonstrably effective and safe addition to the therapeutic options would~     be a significant advance in treatment. Therapeutic ultrasound at present appears a promising~     option, having a very good safety record but so far uncertain evidence of efficacy.~      In our trial patients, with mild carpal tunnel syndrome, confirmed by nerve conduction~     studies, will all be given wrist splints so that no patients will be left untreated. They~     will be randomly allocated to either therapeutic or sham ultrasound therapy (20 sessions over~     7 weeks) and followed up for 1year. The patients, operators of the ultrasound equipment and~     assessors will all be blind to treatment allocation.~      The effect of treatment on symptoms will be assessed using a validated questionnaire and~     nerve conduction studies will be repeated at completion of the ultrasound treatment, 6 and 12~     months.~      This study is designed to find out to whether therapeutic ultrasound is an effective~     treatment for carpal tunnel syndrome (CTS).~   "
150945|NCT01590732|"~     The goal of this clinical research study is find the highest tolerable dose of romidepsin~     that can be given in combination with ifosfamide, carboplatin, etoposide (ICE) to patients~     with PTCL. The safety of this drug combination will also be studied.~      Romidepsin is designed to stop the growth of cancer cells and block new blood vessels from~     forming around the cancer cells. This may cause the cancer cells to die.~      Ifosfamide and etoposide are designed to slow or stop the growth of cancer cells.~      Carboplatin is designed to interfere with the growth of cancer cells by stopping cell~     division, which may cause the cells to die.~   "
150946|NCT01590719|"~     This randomized, multicenter, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with~     metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients~     will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in~     combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo~     until disease progression, unacceptable toxicity, patient or physician decision to~     discontinue treatment.~   "
150947|NCT01590706|"~     -  Although aging process appears to be generally characterized, investigators have been~          paid much attention to the specific target molecules, which leads to discover the~          clinical markers of the senescence. The present study is to investigate the clinical and~          biological profile of cognitive decline and functional cardiac senescence in healthy~          middle aged and elderly Korean volunteers.~        -  This study was conducted as a cross-sectional, single-center, comparative clinical~          study.~        -  Each volunteer was given informed consent for checking cognition and cardiac function.~          Blood and urine samples were collected to analyze genome, proteome, and metabolome to~          assess cognition and cardiac function of its muscle enzymes.~   "
151029|NCT01589627|"~     The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for~     wrist extension contracture following a distal radius fracture.~   "
150951|NCT01590654|"~     Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2~     mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and~     activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are~     required periodically through day 43. Subjects with sustained reductions in HbsAg will be~     requested to return for additional follow-up follow-up visits at 3 and 6 months post last~     dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic,~     and safety assessments~   "
150952|NCT01590641|"~     Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2~     mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and~     activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up~     visits are also required periodically through day 43, and potential viral load follow-up~     visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for~     pharmacokinetic, pharmacodynamic, virologic, and safety assessments~   "
150953|NCT01590628|"~     Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a~     UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells and a Second,~     Unmanipulated CBU in Patients with Hemoglobinopathies.~   "
150954|NCT01590615|"~     This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of~     follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of~     liver decompensation, death, or conclusion of the registry.~   "
150955|NCT01590602|"~     The study aims to monitor the progression of symptoms and signs of those affected by JHD~     using modified UHDRS scales of motor and function (functional assessment, TFC). This will~     provide some basic data to analyse the usefulness of the proposed rating scales.~     Specifically, the initial aim is to assess these rating scales using an iterative process.~      There may be significant delays in diagnosis of JHD especially if the young person presents~     with behavioural problems. Caregivers will be asked questions to capture the number of~     contacts with professionals in the time between onset of concerns about the young person and~     the confirmation of diagnosis.~      Aim is to monitor the progression of symptoms and signs of those affected by JHD using~     modified UHDRS scales of motor and function (functional assessment, TFC). This will provide~     some basic data to analyse the usefulness of the proposed rating scales.~   "
150956|NCT01590589|"~     This is a multi-centre, multi-national, prospective, observational study of Huntington's~     disease (HD) with a control group of volunteers to:~        -  obtain natural history data on many HD mutation carriers and individuals who are part of~          an HD family~        -  relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers)~        -  expedite identification and recruitment of participants for clinical trials~        -  develop and validate sensitive and reliable outcome measures for detecting onset and~          change over the natural course of premanifest and manifest HD which may also be~          potential outcome measures for use in future clinical trials and clinical care~        -  plan for future research studies~   "
150957|NCT01590576|"~     The purpose of this study is to investigate the comorbidities of lower urinary tract symptoms~     or pelvic organ prolapse in a nationwide population-based data in Taiwan during the study~     period of 2001-2010, a total of 10 years.~   "
150958|NCT01590563|"~     Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion,~     malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is~     inserted in a similar fashion into the uterus and takes a three dimensional spherical shape~     while curving away from the fundus. Apart for an anticipated reduction in the rate of stated~     complications, its smaller size and mallable characteristics are also expected to improve~     user experience. The clinical trial is intended to evaluate the safety and initial efficacy~     of this novel device.~   "
150959|NCT01590550|"~     Providing hemodialysis requires the use of an extracorporeal circuit which must be~     anticoagulated. Inadequate anticoagulation can result in the dialyzer clotting with decreased~     circuit blood flows, inefficient dialysis and even significant blood loss secondary to~     circuit clotting.Heparin has been traditional agent used to provide anticoagulation. Heparin~     has multiple adverse side effects that would be best avoided in acutely ill patients who are~     at risk for bleeding. Alternative means of providing anticoagulation include citrate based~     anticoagulation. Citrasate® is a heparin free anticoagulant alternative that has been FDA~     approved since 1999 and readily available for commercial use since 2001. Citrasate® utilizes~     citric acid instead of acetic acid for acidification; the presence of small amounts of~     citrate in the dialysate also provides the means for anticoagulation. The concentration of~     citrate is low (2.4meq/L) and thus has a minimal effect on serum calcium values. No calcium~     monitoring or infusion is indicated.~      The purpose of this study is to obtain further data on the use of Citrasate® in admitted~     pediatric patients who receive hemodialysis as part of their therapy for acute kidney injury.~   "
150960|NCT01590537|"~     This is local prospective, non-interventional multi-center comparative study. Primary study~     objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after~     insertion ( patient assessment questionnaire) in daily practice. For each patient, the~     treating gynecologist documents demographics, medical data, safety parameters and treatment~     signs and symptoms at an initial visit and one or two follow-up visit(s).~   "
150961|NCT01590524|"~     The purpose of this study is to determine whether Guided Imagery and Progressive Muscle~     relaxation are effective as stress reducing techniques in parents of hospitalized children~     with cancer.~   "
150962|NCT01590511|"~     The main objective of this study is to show that the variation of the subaortic velocity time~     integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is~     predictive of response to filling (defined as an increase in aortic velocity time integral~     measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline~     over 15 minutes) in non-ventilated shock patients.~   "
150963|NCT01590498|"~     The purpose of the study is to determine whether radiotherapy improves cancer control and~     overall survival among patients with Castration resistant prostate cancer.~   "
150964|NCT01590485|"~     The purpose of this study is to determine whether saffron is effective in the pain control~     after root canal therapy in vital teeth.~   "
151030|NCT01589614|"~     The purpose of this study is to investigate the effect of co-administration with erythromycin~     on the time course of PH-797804 concentration in the blood following dosing by oral immediate~     release tablet formulation.~   "
150965|NCT01590472|"~     The purpose of this research study is to investigate the possibility that a person's genes~     put a person at a higher risk of developing mesothelioma. The investigators will examine~     genes from DNA (genetic material) isolated from blood. This study will also examine the~     impact of environmental and work exposures and family history of common cancers on the~     development of mesothelioma. The genetic markers in this study will basically identify how a~     person's body processes frequently encountered environmental pollutants and will not tell~     about chromosomes, specific diseases, or other potential health problems.~   "
150966|NCT01590459|"~     This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor,~     for treatment of subjects with active RA who have had an inadequate response to Methotrexate.~   "
150967|NCT01590446|"~     The purpose of this study is to measure how much of the study drug gets into the blood-~     stream and how long it takes the body to get rid of it when given as a single dose.~     Information about any side effects that may occur will also be collected.~   "
150968|NCT01590433|"~     The investigators are conducting a study that will investigate the possible mechanisms of~     weight loss associated with exenatide treatment and the metabolic characteristics of high~     responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment.~     The investigators will also examine the magnitude and duration of weight loss among a cohort~     of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment.~      Hypothesis:~      The mechanisms of weight loss with exenatide are not fully understood, and weight loss~     responses to exenatide are highly variable, possibly reflecting distinct metabolic~     parameters. By identifying and following a group of obese women who lose greater than 5% body~     weight after short-term exenatide treatment, the investigators can gain insights into the~     possible mechanisms of weight loss and assess long-term weight loss with this~     pharmacotherapeutic intervention.~   "
150969|NCT01590420|"~     The purpose of this study is to estimate the cost-utility of continuous positive airway~     pressure (CPAP) therapy in obstructive sleep apnea (OSA) patients in Sao Paulo city, Brazil,~     after 3 years of treatment and to estimate the cost-effectiveness of CPAP on the number of~     medical visits, hospitalizations, medical examinations, used medications, new case incidence~     and cost of traffic accidents and absence from work. It is also designed to estimate~     quality-adjusted extended years of life, and to assess cost-effects of the therapy (device,~     masks, supplies, maintenance/year for membership of professional consulting, electric power)~     on the cost-effectiveness~   "
150970|NCT01590407|"~     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,~     tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers~     (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.~      Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will~     assess food effects on pharmacokinetics in HV. Part 3 will assess multiple ascending dosing~     pharmacokinetics and safety in subjects with CHC genotype 1 infection.~   "
150971|NCT01590394|"~     Plastic biliary stents which are a new larger size will remain free of obstructions for a~     longer period of time than currently used 10 French stents in cancer in the common bile duct.~   "
150972|NCT01590381|"~     The purpose of this study is to assess HBV immunity and institute policy regarding the~     Hepatitis B vaccination practices in the IDF among a cohort that was vaccinated during~     infancy.~   "
150973|NCT01590368|"~     It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram~     (ECG) trace is comparable between the two groups (marketed and test products) after 30~     minutes (the intended period of use) of the electrodes.~   "
150974|NCT01590355|"~     The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx~     is radiation therapy. Some patients require chemotherapy with the radiation, and some~     patients require surgery if the tumour or lymph nodes have not responded after radiation.~      This study will compare radiation therapy with a new surgical treatment called transoral~     robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon~     in removing the tumour, potentially with fewer side effects than older surgical techniques.~   "
150975|NCT01590342|"~     The primary objective is to demonstrate the clinical benefits of diclofenac (added to~     standard anticoagulant therapy) over placebo in normotensive patients with acute symptomatic~     pulmonary embolism and right ventricular dysfunction.~      The secondary objective is to assess the safety after administration of diclofenac in~     normotensive patients with acute symptomatic pulmonary embolism and right ventricular~     dysfunction.~   "
150976|NCT01590329|"~     This case series will assess the use of suction blister epidermal grafts harvested by a novel~     device on select patients with hypo pigmented skin or surgical skin wounds.~   "
150977|NCT01590316|"~     Background 25,000 infants are born extremely preterm every year in Europe. This group of~     infants carries a high risk of death and subsequent cerebral impairment for the infant,~     especially in the first 72 hours of life. Mortality is about 20%, and about 25% of survivors~     live with either cerebral palsy or low intelligence quotient. Preventative measures are keys~     to reducing mortality and morbidity in this population. There is evidence that the cerebral~     oxygenation time spent out of range (time with hypoxia or hyperoxia) is associated with poor~     outcome in infants. Near-infrared spectroscopy (NIRS) has been used to monitor tissue~     oxygenation since the mid-1980s, and quantification of oxygenation (rStO2) in a percentage~     from 0 to 100% has been possible for 10 years. From almost 400 preterm infants normal ranges~     of rStO2 has been determined to be from 55% to 85%. Still, there are no clinical trials and~     thus no solid evidence of the clinical utility of NIRS in preterm infants. Thus, research on~     the benefits and harms of cerebral monitoring using NIRS as a part of clinical management of~     premature infants is much needed.~      Objectives The primary objective of the SafeBoosC trial is to examine if it is possible to~     stabilise the cerebral oxygenation of extremely preterm infants during the first 72 hours of~     life through the application of cerebral NIRS oximetry and implementation of an~     rStO2-specific clinical treatment guideline. We hypothesise that by using the specified~     treatment guideline to respond to cerebral monitoring readings outside the target range, we~     would reduce the burden of hypo- and hyperoxia and consequently reduce brain injury.~      Trial design This is an investigator-initiated randomised, blinded, multinational, phase II~     feasibility clinical trial involving preterm infants from 12 European countries.~      Inclusion criteria The inclusion criteria are: neonates born more than 12 weeks preterm~     (gestational age up to 27 weeks and 6 days); decision to conduct full life support; parental~     informed consent; and cerebral NIRS oximeter placed within 3 hours after birth.~      Sample size With a 50% reduction of the area outside the normal range of oxygenation in~     %hours in the experimental group compared to the control group as the minimal clinically~     significant difference, a standard deviation of the area outside the normal range of 83.2~     %hours, a type I error (alpha) of 5%, and a type II error of 0.05 (power of 95%) inclusion of~     75 preterm infants in the experimental group and 75 preterm infants in the control group is~     required. The inclusion of twins are likely to decrease power, so it has been decided to~     increase sample size to 165 on a pragmatic basis of estimating intracluster correlation,~     control event rate, and incidence of twin births.~      Intervention The premature infants will be randomised into one of two groups (experimental or~     control). Common is that both groups will have a cerebral oximeter monitoring device placed~     within three hours after birth. In the experimental group, the cerebral oxygenation reading~     is visible, and the infant will be treated accordingly using a defined treatment guideline.~     In the control group, the cerebral oxygenation reading is NOT visible, and the infant will be~     treated as usual.~      Trial duration Monitoring by cerebral oximeter will be started as soon as possible and within~     3 hours after birth and the intervention will last for 72 hours. Thereafter, each neonate~     will be followed up at term date (approximately three months after birth) and at 24 months~     after term date.~      Outcome measures The primary outcome is the burden of hypo- and hyperoxia in %hours during~     the first 72 hours after birth. The secondary outcomes are brain activity on an~     amplitude-integrated electroencephalogram (aEEG), blood biomarkers (brain fatty acid binding~     protein (BFABP), neuroketal, and S100β), serious adverse reactions (SARs), severe brain~     injury, and all cause mortality at term date (approximately three months after birth). The~     exploratory outcomes are burden of hypoxia, burden of hyperoxia, neonatal morbidities, brain~     injury score on magnetic resonance imaging (MRI), number of therapies implemented during the~     intervention, physiological variables (mean blood pressure (BP), pulse oximeter oxygen~     saturation (SpO2), and partial pressure of carbon dioxide (pCO2)), and psychomotor impairment~     according to neurodevelopmental scales at 24 months after term date.~   "
150978|NCT01590303|"~     This study is designed to determine if Vitamin C administration to septic patients will~     result in an improvement in organ dysfunction which occurs during a septic illness.~      Hypothesis: 1. Vitamin C in sepsis will reduce the injury to organs 2. Vitamin C will reduce~     the length of time on a ventilator, length of stay in the intensive care unit and in~     hospital.~   "
150979|NCT01590290|"~     The purpose of this study is to determine if a pay for performance model in contrast to the~     traditional fee for service model may improve the number of patients discharged being~     treated in accordance with Joint Commission on Health Care JCAHO (a non-for profit~     organization that accredits health care organizations) standards and standard of care for~     management of hyperlipidemia~      In this study the investigators will evaluate these two models by training resident~     physicians (doctors in training) on JCAHO core measures and specific criteria related to~     accepted standard of care for acute myocardial infarction and heart failure. The physicians~     will be randomized to a pay for performance or a fee for service model. Then a medical record~     review will be performed on patient records that received a discharge diagnosis of myocardial~     infarction or heart failure and were cared for by the physician subjects~   "
150980|NCT01590277|"~     Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is~     looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's~     effects on driving an automobile.~   "
151031|NCT01589601|"~     The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary~     palliative care intervention combined with usual heart failure management on health-related~     quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the~     Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.~   "
150981|NCT01590264|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) is a novel brain stimulation technique~     that uses pulsating magnetic fields to stimulate underlying neurons in the cerebral cortex.~     The investigators propose an open-label pilot study investigating the effectiveness of rTMS~     in the treatment of tinnitus stimulation of the left dorsolateral prefrontal cortex (DLPFC),~     an area known to be important for mood and attention, along with stimulation of the left~     temporoparietal cortex (TPC). This is a feasibility pilot study.~   "
150982|NCT01590251|"~     This study is designed to develop an effective adjunctive treatment using yoga for chronic~     pain and opioid dependence.~   "
150983|NCT01590238|"~     Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active~     production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal~     findings of improvement of hair appearance after PRFM injection in the scalp suggest that~     PRFM may play a role in the treatment of thinning hair. Patients will be treated on a monthly~     basis with intradermal injections of autologous PRFM for 3 months. Changes in hair density~     will be assessed by comparing pre- and post-treatment photographs and non-invasive~     measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.~   "
150984|NCT01590225|"~     This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of~     boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part~     A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are~     non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to~     (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment~     failure) (Part B). Part C is long-term follow up and no study treatment will be administered~     during this period, but participants who do not achieve viral clearance will be allowed to~     receive other treatments for CHC.~   "
150985|NCT01590212|"~     The purpose of this study is to compare the effectiveness of a relationships based antenatal~     intervention (Mellow Bumps) against a comparison intervention (Chillout In Pregnancy) and~     also against the normal antenatal care which is received during pregnancy (Care As Usual).~     The Mellow Bumps intervention will seek to improve maternal anxiety and maternal sensitivity~     whilst the Chillout In Pregnancy intervention will aim to improve only maternal anxiety. This~     will allow the researchers to determine what type of intervention, if any, is most successful~     at improving the outcomes of the mother and child. This will be measured by looking at the~     mother's stress response, anxiety, depression and irritability, the baby's stress response~     and the interactions between the mother and the baby. Participants in the study will be~     pregnant women who would be between 20 and 30 weeks pregnant at the start of the antenatal~     intervention. Participants will be chosen to take part in one of the three conditions (Mellow~     Bumps, Chillout In Pregnancy or Care As Usual) at random. All participants will be asked to~     complete questionnaires and give saliva samples prior to the intervention. The questionnaires~     will also be repeated at the end of the intervention and at a follow up occurring eight to~     twelve weeks after birth. Consent will also be sought to take saliva samples from the baby~     before and after a routine blood test when the baby is five days old. This information will~     then be evaluated to establish the effectiveness of the proposed interventions.~   "
150986|NCT01590199|"~     This study will evaluate long-term safety and tolerability of pasireotide LAR in combination~     with everolimus in advanced metastatic NET patients, who who have not progressed during 12~     months of combination therapy with pasireotide LAR and everolimus~   "
150987|NCT01590186|"~     Tibial flat foot deformity is the most common reason for metatarsalgia. Flat foot deformity~     is a sign of degenerated problems such as weakness in ligament or fractures. Furthermore,~     metatarsalgia can be a sign of excessive load caused by sport activities or at work. The~     condition is very common at diabetics and patients with rheumatism.~      The purpose of the study is to examine the load under the front foot at health people and~     patients with metatarsalgia. Furthermore, the researchers aim at being able to assess the~     best treatment of the flat foot deformity at each patient.~   "
150988|NCT01590173|"~     The addition of heparin and prednisolone increases pregnancy outcome parameters in women~     undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.~   "
150989|NCT01590160|"~     Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal~     pleural mesothelium, and is associated with exposure to asbestos.~      Once a rare disease, it is increasing in incidence in the UK and is presently more common~     than cervical cancer. MPM is characterized by local invasion of adjacent structures including~     the chest wall, mediastinum, diaphragm and pericardium resulting in progressive shortness of~     breath.~      Median survival with best supportive care alone is approximately 6-9 months and most cases of~     mesothelioma present in the advanced setting. Therefore this trial will be looking at whether~     a new drug, Ganetespib has any improvement on survival for these types of patients.~   "
150990|NCT01590147|"~     This randomized clinical trial studies the preliminary efficacy of a yoga skills training~     (YST) compared to counseling and education (CE) for reducing treatment-related symptoms in~     patients with colorectal cancer who are receiving chemotherapy. The YST may reduce fatigue,~     other treatment-related symptoms, and improve the quality of life (QOL) of patients with~     colorectal cancer. It is not yet known whether YST is more effective then CE in reducing~     these outcomes.~   "
150991|NCT01590134|"~     Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat~     anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators~     think that there could be ways to reduce the number of iron tablets needed, by increasing the~     dietary intake of iron. In this study the investigators will assess the efficacy and safety~     of a dietary iron supplement compared to iron tablets using controls and new biomarkers.~   "
150992|NCT01590121|"~     Hereditary Haemorrhagic Telangiectasia (HHT) is a condition in which sufferers have abnormal~     blood vessels which makes them more likely to bleed than other people, particularly in the~     lungs, which results in low blood oxygen levels. Flying may make this worse and cause~     problems. The investigators want to know if there are an increased number of problems on~     flights compared to on land.~      The investigators currently do not have any evidence based guidelines on air travel to best~     advice people who suffer with HHT. The investigators would therefore like to ask individuals~     who have HHT about their experience on a flight, using a postal questionnaire.~   "
151032|NCT01589588|"~     This study will investigate the possible difference in treatment effect between three~     different oxygen delivery systems in the acute treatment of cluster headaches.~   "
150993|NCT01590108|"~     The purpose of this study is to~        -  Determine blood peptide levels and investigate any tissue gradients of apelin in~          patients with idiopathic pulmonary arterial hypertension and healthy volunteers.~        -  Evaluate the effect of exogenous apelin infusion on exercise performance in healthy~          volunteers and patients with idiopathic pulmonary arterial hypertension.~   "
150994|NCT01590095|"~     Brief Summary:~      The purpose of this study is to measure the independent and combined effects of interventions~     that improve water quality, sanitation, hand washing, and nutrition on child growth and~     development in the first years of life.~   "
150995|NCT01590082|"~     The goal of this clinical research study is to find the highest tolerable dose of doxycycline~     that can be combined with temozolomide and ipilimumab in patients with advanced melanoma. The~     safety and level of effectiveness of the study drug combination will also be studied.~      Doxycycline is designed to treat bacterial infection. It also blocks a protein called iNOS~     that is important in tumor cell growth, which may slow the growth of or kill cancer cells.~      Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of~     cells). This may stop the cancer cells from dividing into new cells.~      Ipilimumab is designed to block the activity of cells that decrease the immune system's~     ability to fight cancer.~   "
150996|NCT01590069|"~     If you are reading and signing this form on behalf of a potential participant, please note:~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is find the highest tolerable dose of interleukin-2~     (IL-2) that can be given as an inhaled mist to patients with lung metastases. The safety of~     this drug using this administration will also be studied.~      IL-2 is a protein that triggers white blood cells, called natural killer cells or T-cells, to~     kill cancer cells. When given as a shot or by vein, IL-2 has been known to cause fevers and~     flu-like side effects, including rashes, fatigue, and extra fluid in the skin or lungs. These~     symptoms are less when IL-2 is inhaled as a mist into your body.~      This is an investigational study. IL-2 is FDA approved and commercially available when given~     by vein to patients with melanoma and renal cell carcinoma. Its use in patients with lung~     metastases and when given as an aerosol mist into the lungs is investigational.~      Up to 56 patients will take part in this study. All will be enrolled at MD Anderson.~   "
150997|NCT01590056|"~     About 300 patients with Parkinson's disease (PD) have been successfully treated by deep brain~     stimulation (DBS) during the last 10 years in Hadassah. In most of the patients the site of~     stimulation is the subthalamic nucleus (STN). Recent studies by our group and others have~     demonstrated that the STN is divided into motor and non-motor areas. The investigators have~     recently shown that electrophysiological mapping of the STN during the surgery can~     differentiate motor and non-motor areas of the STN. Existing methods of adjustment of DBS~     parameters aim at amelioration of the motor signs and therefore with inactivation of the STN~     motor territory only. Although the DBS parameter setting is believed to influence the mental~     and cognitive states, there is no data that correlates stimulation parameters with mental and~     cognitive state. In addition, DBS parameter setting is also believed to influence important~     verbal functions which are partially related to motor, mental and cognitive states, but no~     data correlates the verbal function with the DBS stimulation parameters.~      The investigators hypothesize that the cognitive areas of the STN have distinct~     electrophysiological properties similar to our findings with the limbic / mental areas of the~     STN. The investigators further hypothesize that specific stimulation of these cognitive areas~     can influence the cognitive state and thus treatment with cognitive-adjusted DBS can improve~     the cognitive symptoms of PD.~      In this project, the investigators intend to map the motor, emotional and cognitive areas of~     the STN using neuronal (single units) responses to emotional voices and cognitive tasks and~     to identify the emotional and cognitive spectral signature of the STN single unit activity~     using spectral analysis and neuronal responses to emotional voices and cognitive tasks. In~     addition the investigators intend to find the neuronal signature of speech and to find the~     correlation between motor, mental and limbic electrophysiology to speech. The investigators~     also intend to investigate the motor, emotional and cognitive processing of PD patients by~     manipulating the stimulation of the STN. The proposed study will combine neural recording,~     stimulation and psychological and cognitive tests to shed new light on processing in the~     basal ganglia, as well as to provide better treatment for PD patients.~   "
150998|NCT01590043|"~     Under normal conditions intestinal mucosa presents a baseline physiological inflammation~     caused by a controlled immune response that eliminates offending dietary and microbial~     antigens. This inflammation disappears once the cause is eradicated. In case of inappropriate~     immunological response, the inflammation becomes chronic and harmful, resulting in anatomical~     and functional abnormalities, namely inflammatory bowel disease (IBD).~      Although it is critical for the IBD patients to undergo early diagnosis and management before~     the development of severe complications, but as IBD has vague and non-pathognomonic clinical~     features, the clinician is usually mislead into late suspicion and detection of IBD.~      Diagnosis traditionally depended on a combination of pathologic evaluation together with the~     histological, clinical, radiological, endoscopic, surgical, laboratory (serological)~     features. Recently, serological markers were identified and became of special interest as~     they do not only detect the occurrence of IBD but also the potential of its development and~     may be used as prognostic tools. More recently, stool markers were detected and used for~     diagnosis.~      Up to now, the market is still lacking a definitive, simple and non-invasive diagnostic tool.~     Saliva can present an alternative form of body fluids that simplify diagnostic procedures.~      Our hypothesis is that IBD patients have special salivary biomarkers that may be identified~     through salivary analysis, where later on a simple non-invasive test can be applied in the~     form of an easy-to-use kit, being available at the clinician's clinic for the establishment~     of an immediate and early diagnosis of the destructive inflammatory bowel disease.~   "
150999|NCT01590030|"~     The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and~     fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.~   "
151000|NCT01590017|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x rays to kill tumor cells. Giving cisplatin together with~     radiation therapy may be an effective treatment for cervical cancer.~      PURPOSE: This trial studies how well cisplatin and radiation therapy work in treating~     participants with HIV-associated locally advanced cervical cancer.~   "
151001|NCT01590004|"~     This study aims to develop a technical description of lumbar medial branch ablation using the~     LumbarCool system. The procedure uses cooled radiofrequency (cooled-RF) technology in~     treating patients with diagnosed lumbar facet joint pain.~   "
151002|NCT01589991|"~     Fluoride toothpaste has been associated not only with declining dental caries prevalence but~     also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride~     toothpaste use, the purpose of this study is to evaluate the availability of fluoride~     concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries~     effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from~     ingested toothpastes (with potential to cause dental fluorosis), in a sample of young~     Brazilian children using toothpaste formulations representative of those available and most~     used by this age-group.~   "
151003|NCT01589978|"~     This study is designed to observe clinical outcomes in patients receiving the PROMUS Element~     Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.~     Patients will have symptomatic heart disease or documented silent ischemia. This is a~     prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years.~     Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.~   "
151004|NCT01589965|"~     The HIV/AIDS epidemic is a major concern in many countries. The epidemic is especially acute~     in Lesotho where roughly one quarter of the population is infected by HIV/AIDS. In Lesotho,~     and elsewhere, new innovative approaches to induce safer sexual behavior have been~     desperately called for, particularly in view of the limited impact that existing prevention~     schemes have had on the trajectory of the HIV/AIDS epidemic.~      One of the key questions is to understand why individuals get involved in short-term risky~     sexual behavior when the potential long-term cost of becoming HIV infected is so high? A~     follow-up question is what replicable and feasible interventions can affect this trade-off~     between short and long run returns? The primary aim of this study is to evaluate whether the~     use of short-term financial incentives can affect this trade-off, thereby influencing young~     individuals' decisions with respect to sexual and reproductive health behavior, and thus in~     the end reduce HIV incidence rates. The investigators will study this question using a sample~     of population attending served by New Start Voluntary Counseling and Testing (VCT) sites that~     a local NGO, Population Service International (PSI), has already implemented in Lesotho.~      The investigators propose to conduct a randomized controlled trial to test whether adding a~     financial incentive to remain STI-negative in the form of a lottery can promote safer sexual~     activity. The lotteries will work as follows: if the individual is tested negative on a set~     of curable STIs, she will get a lottery ticket with the chance to win a big prize. If she~     is tested positive, she will receive free treatment, but no lottery ticket. If an individual~     who tested positive is cured, she can come back in the lottery system and get a later chance~     to win the lottery ticket if she remains STI-negative. The outcome will be to measure the~     impact of financial incentives on HIV incidence after two years.~      The results of this research project will be disseminated through academic and non-academic~     conferences, workshops, publications in academic journals, and also in policy journals with~     the aim to reach out to policy makers outside the research community.~   "
151005|NCT01589952|"~     According to published literature, treatment with pegylated interferon (Peg-IFN) is~     associated with end of treatment response in treatment naive patients with chronic hepatitis~     B (CHB). It has antiviral as well as anti-fibrotic properties and treatment with Peg-IFN~     results in improvement of liver histology and down regulation of progression to cirrhosis of~     liver. Peg-IFN is administered for a finite duration. The major limitation of Peg-IFN is that~     only 30-49% patients are benefited by this anti-viral drug. Another potent anti-viral drug,~     entecavir (ETV), on the other hand, reduces HBV replication in most patients, but causes~     improvement of liver histology in only 30%, possibly because of its lack of immune modulatory~     ability like Peg-IFN. Also, ETV treatment is associated with several complications like~     emergence of HBV mutant. The aim of this study is to assess whether the combination of these~     two 'unique' anti-viral drugs offer the best possible outcome to treatment-naïve CHB~     patients, in terms of treatment response (virological and biochemical), treatment cost and~     duration and adverse events.~   "
151006|NCT01589939|"~     This prospective study evaluates the clinical utility of a novel real-time localization~     system allowing for smaller volumes of normal tissue to be included in radiation field and~     determines dosimetric parameters and adverse effect profiles of radiation therapy using this~     technology. Subjects will have beacon transponders implanted into the prostate to more~     precisely localize the position of the organ during radiation therapy. Hypothesis: 1.~     Treatment with highly targeted radiation therapy can be delivered in a daily treatment time~     consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced~     PTV margin will result in a significant decrease in rectal and bladder volume treated.~   "
151007|NCT01589926|"~     Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is diagnosed~     by having findings on a chest x-ray and one of the following: chest pain, fever, or trouble~     breathing. Patients with Acute Chest Syndrome can get very sick and require an exchange~     transfusion (special large blood transfusion) and mechanical ventilation. Bi-level Positive~     Airway Pressure (BLPAP) is a device that blows air into a patients lungs via a mask that~     covers the nose. Our goal is to determine whether giving children BLPAP when they have ACS,~     in addition to providing standard clinical care for ACS alters the clinical course of these~     patients. The investigators hypothesize that patients receiving effective BLPAP will have~     milder clinical courses resulting in shorter hospital stays and fewer transfers to the~     intensive care unit and exchange transfusions.~   "
151008|NCT01589913|"~     Aim and Background: Although implantable cardioverter defibrillators (ICD) save lives, many~     ICD-patients experience psychosocial complications such as anxiety disorders, depression and~     reduced quality of life after ICD-implantation. A recent review has indicated great potential~     for psychosocial interventions to reduce anxiety and to increase exercise capacity of~     ICD-patients. In a previous study, the investigators showed that mailed information about~     technical, medical and psychological effects of ICD plus phone counseling are effective~     interventions for reducing anxiety, psychological distress and increasing QoL in ICD-patients~     < 65 years. In a pilot study the investigators also documented promising effects of an~     internet based intervention with similar content.~      Method: In a prospective, multicenter, multidisciplinary, half-open, part-randomized,~     controlled clinical trial N = 200 patients with an ICD will either receive medical care as~     usual or additionally attend a psychosocial prevention program via remote care. Psychosocial~     support will be provided utilizing the advantages of the internet. Thus, patient-centered~     support will be offered independent from time and location.~      Outcome measures are psychometric data (questionnaires on cardiac fear, etc.), cardiac~     functioning, and clinical status which will be assessed up to 1 week before ICD-implantation~     (T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12~     months after T0 (T3). Furthermore, demographic data, personality characteristics,~     expectations, physiology, pro-inflammatory cytokines and cardiac status will be assessed as~     mediating or moderating variables.~      Hypotheses: A web-based psychosocial intervention in addition to medical care as usual leads~     to increased QoL and reduced anxiety and depression. Secondary goals are the identification~     of psychosocial and medical predictors, mediators, and moderators of treatment efficacy.~     Moreover, differences between patients with ICDs implanted for primary vs. secondary~     prevention will be explored.~      Conclusion: This project will evaluate the feasibility and efficacy of an internet based~     intervention for ICD-patients. Furthermore, the investigators aim at identifying predictors~     and mediators of treatment outcome. This will improve interdisciplinary care for~     ICD-patients; further applications for other cardiovascular disorders as well as preventive~     programs for heart failure seem possible.~   "
151009|NCT01589900|"~     Sox2 has been studied in several types of human solid tumors. The investigators found that~     Sox2 had higher expression level in colorectal cancer and metastatic tissues than normal~     tissues. So the investigators assumed that whether Sox2 plays an important role in the~     progression and migration of colon cancer.~   "
151033|NCT01589575|"~     The main objective of this study is to compare the rate of reported anxiety / depression~     (HADS >= 8) among spouses and other family members in ICU patients.~   "
151034|NCT01589562|"~     The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and~     Megace 800mg/20ml in healthy male volunteers under fed condition.~   "
151035|NCT01589549|"~     A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy~     for newly diagnosed acute graft versus host disease after bone marrow transplantation or~     donor lymphocyte therapy.~      It is hypothesised that mesenchymal stromal cell therapy will be superior~   "
151010|NCT01589874|"~     Anemia of inflammation (AI), a normochromic, normocytic anemia, associated with abnormal iron~     utilization, erythropoietin hyporesponsiveness, and decreased red blood cells (RBC) survival~     is a very common problem in hospitalized patients for acute inflammatory diseases and~     develops within few days from the onset of illness. Deleterious effects of anemia include~     increased risk of cardiac related morbidity and mortality in critically ill and older~     patients.~      Anemia is mediated by hepcidin, the 25-amino acid polypeptide hormone that is central to iron~     trafficking.~      Several studies have been performed on pathophysiology of AI in patients affected by chronic~     diseases but few explore iron metabolism in humans with acute inflammation.~      The aim is to develop effective new strategies to detect and manage AI in the setting of~     acutely ill patients, based on the understanding of iron balance underlying this disorder.~   "
151011|NCT01589861|"~     This study is based upon the following points:~        1. Resistance to trastuzumab, either primary or secondary, is a clinically relevant issue.~        2. PI3K/AKT activation, due to loss of expression/function of PTEN and/or activating~          mutations of PIK3CA, is a mechanism of resistance with clinical relevance in breast~          cancer. Such activation can be detected by:~             -  IHC evaluation of PTEN protein expression~             -  genotyping of PIK3CA exon 9 and 20~             -  IHC evaluation of phospho-AKT expression~        3. BKM120 is an effective PI3K inhibitor. BKM120 and anti-HER2 therapy may have a~          synergistic antitumor activity in preclinical model of HER2+ breast cancer.~        4. Lapatinib is an effective anti-HER2 therapy in trastuzumab-resistant disease.~        5. For the evaluation of novel targeted therapies, selecting a patient population enriched~          for activation of the target to be modulated should allow to maximize the differences in~          clinical outcome that are expected in the experimental arm, and thus to minimize the~          patient number to include.~        6. We propose to test in a phase I/II study the combination of lapatinib and BKM120 in~          trastuzumab-resistant HER2+ MBC patients, enriched for activation of PI3K/AKT as~          detected by loss of expression of PTEN (IHC), and/or mutation of PIK3CA and/or~          overexpression of phospho-AKT (IHC). Only for phase II patients, mutational status will~          be an inclusion criteria. For phase I patients molecular status will be a retrospective~          exploratory analysis.~   "
151012|NCT01589848|"~     1. Hypothesis~           a. There are patients with von Willebrand Disease in Cuenca.~        2. Primary question~           a. How many women referred with a history of bleeding may have von Willebrand disease?~        3. Secondary~             1. Associations between the bleeding score and initial laboratory studies~             2. What are the differences on subgroups of enrolled patients with the bleeding score?~        4. Ancillary~             1. What is the clinical and socio-economic status of women with von Willebrand Disease~               in Cuenca?~             2. What is the clinical and socio-economic status of patients with Hemophilia in~               Cuenca?~   "
151013|NCT01589835|"~     Nearly six million Canadians are living with an increased risk of diabetes (prediabetes) and~     approximately 50% of these will develop type 2 diabetes within five years. The investigators~     wish to help these people change their lifestyle, to prevent them from getting diabetes.~     Trials have shown that by supporting people with prediabetes to be more active and have~     healthier eating habits they can halve their risk. However, these interventions were very~     costly and not performed in Canada. With the help of local Family Physicians and other health~     professionals (e.g. physiotherapy, psychology, endocrinology, nursing) the investigators have~     created a less expensive intervention suitable for the Canadian population and health system.~     The investigators need to perform a study to see whether these modified approaches are~     practical for Canadians and likely to be effective. People at risk will be invited to~     participate from family practices that have helped us in the initial stages of this program.~     Family practices will be randomized to giving either the study intervention or continue with~     the physician's usual care. People receiving the intervention will have an appointment with~     their family doctor to discuss their exercise and eating habits and agree changes that are~     necessary. A prescription detailing these changes will be completed and signed by the family~     physician and participant. Participants will be given the name of a lifestyle change~     facilitator (LCF) who will receive a copy of the prescription and contact the participant to~     help them set achievable goals. The LCF will contact participants once a month for six months~     to help them achieve these goals. The investigators eventual aim is to test this intervention~     in a large-scale randomized control trial. To achieve this it is necessary to pilot all~     aspects of the trial. Information from the pilot study can then be used to design and perform~     a large-scale study effectively. The investigators hope that eventually the numbers of~     Canadians progressing to having diabetes will be reduced.~   "
151014|NCT01589822|"~     The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin~     Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.~   "
151015|NCT01589809|"~     The purpose of the interventional study is to determine whether Nicotinamide is effective at~     upregulating the Frataxin (FXN) gene in patients with Friedreich's ataxia (FRDA) where this~     gene is abnormally 'switched off'.~      The purpose of the non-interventional study is to investigate the use of novel,~     highly-sensitive technology to capture clinical deficit and measure subtle changes in the~     activities of daily living and to correlate functional changes to levels of expression of~     Frataxin protein and the epigenetic structure of the Frataxin gene over a 9-12 month period~     without nicotinamide. Healthy volunteers will be included as comparators in this part of the~     study.~   "
151016|NCT01589796|"~     Pain relief after open inguinal hernia repair could be improved by administration of TAP~     block or ilioinguinal/iliohypogastric nerve block. It is unclear which one works better. The~     investigators hypothesize that doing TAP block closer to the middle of the abdomen would~     result in improved pain relief due to simultaneous block of ilioinguinal/iliohypogastric~     nerves.~   "
151017|NCT01589783|"~     Vitamin D insufficiency is common globally. Pregnant women, who need an increased supply of~     this vitamin for the proper development of the fetus, are a significant risk group. The~     purpose of this study is to examine which factors - education, knowledge from~     non-professional sources, recommendations from medical staff - influence the use of vitamin D~     among pregnant women in light of the lack of a clear health policy, and to help formulating~     guidelines for a new health policy with specific recommendations for vitamin D dosage in~     pregnancy.~   "
151018|NCT01589770|"~     Studies have shown that people with rheumatoid arthritis (RA) have a higher rate of heart~     disease than people that do not have RA. we believe this is caused by the inflammation~     produced by RA.~   "
151036|NCT01589536|"~     The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological~     interval-intervention, combined with a structured follow up, decreases the rate of disability~     retirements caused by psychosocial co-morbidity of patients with coronary heart disease.~   "
151112|NCT01588522|"~     This will be a dose escalation study to determine the maximum tolerated dose (MTD) and the~     overall safety and tolerability of a topical compound 31543 (Calcitriol) in patients with~     metastatic or recurrent cancer who are undergoing chemotherapy with a taxane-based regimen.~   "
151019|NCT01589757|"~     MAIN STUDY: Low glycaemic index (GI) diets are recommended by the Canadian Diabetes~     Association for treating type 1 and 2 diabetes mellitus (DM), but the role of GI in the~     management of gestational diabetes(GDM)is not yet clear. The main purpose of this study is to~     determine the effect of a low GI diet on blood sugar control in women with GDM. The effect of~     a low GI diet on maternal oxidative stress, pregnancy and delivery outcomes and markers of~     risk for diabetes after birth in both the mother and baby will also be assessed. SUB-STUDY:~     The main purpose of the sub-study is to determine if the breast milk (BM) of women with GDM~     consuming a low GI diet will have a higher antioxidant capacity than the BM of women~     receiving a medium-high GI diet (control/standard care). The effect of a low glycaemic index~     diet on maternal dietary intake of specific nutrient-antioxidants (i.e. vitamin C, E, and~     beta-carotene) (prenatal and postpartum) and concentration of vitamin C, E, and beta-carotene~     in participants' transitional and mature BM will also be assessed. The ORAC (Oxygen radical~     absorbance capacity) assay will be used to assess overall antioxidant capacity. The~     antioxidant capacity of BM in women with GDM will also be compared with that of women without~     GDM.~      Hypotheses:~      MAIN: The use of low-GI foods in the management of GDM reduces postprandial BG and oxidative~     stress; thereby reducing maternal and infant perinatal complications.~      SUB-STUDY: Breast milk (BM) of women with GDM consuming a low GI diet will have higher BM~     antioxidant than women receiving the medium to high GI diet. BM of women with GDM will have~     lower antioxidant capacity than that of women without GDM.~   "
151020|NCT01589744|"~     The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical~     practice, if after giving birth, the placenta is not expelled naturally, an active management~     should be triggered. Escalating therapy after obstetric maneuvers (placenta, uterus,~     examination of the birth canal), begins with uterotonic treatments for invasive treatments~     lead to embolization, vessel ligation and hysterectomy. However, the morbidity of these~     techniques and the desire to preserve fertility required to devise new therapeutic solutions,~     which have recently led to the development of an innovative medical device intrauterine~     hemostasis.~      The postpartum haemorrhage are mainly the result of weak and bleeding from the surface~     corresponds to the placental insertion, which is no longer localized. With the innovative~     medical device, our main hypothesis is that the uterine walls will append to the walls of the~     cup after depressurization of the latter. The actuation of the suction cup will lead to~     aspiration of all sides of the uterus (it is mostly the anterior and posterior that are~     important). The suction cup is flexible to adapt to the size of the uterus in order to be~     placed and removed easily from the uterine cavity.~   "
151021|NCT01589731|"~     Bovine β-lactoglobulin (Bos d 5) is an allergen from cow's milk with relevance to human~     health. We employed β-lactoglobulin polymerized using microbial transglutaminase as a model~     of study to identify whether protein polymerization could reduce in vivo allergenicity and~     maintain in vitro and ex vivo immunoreactivity for the purpose of producing a suitable~     molecule for use in tolerance-induction protocols. Based on previous protocols applied in~     mice and children, we performed in vivo challenges (using a skin prick test) with native and~     polymerized β-lactoglobulin in adult patients with an IgE-mediated allergy to Bos d 5. In~     vitro humoral immunoreactivity was analyzed using immunoblotting. Cell-mediated~     immunoreactivity was analyzed using ex vivo challenges with native and polymerized~     β-lactoglobulin monitored by leukocyte adherence inhibition tests. The study hypothesis is to~     identify a decrease on beta-lactoglobulin immunoreactivity after polymerization.~   "
151022|NCT01589718|"~     The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves~     vitreous hemorrhage prior to surgical intervention and to evaluate the stability of~     pre-existing tractional retinal detachment.~   "
151023|NCT01589705|"~     There are substantial data demonstrating increased endothelial dysfunction, inflammation and~     oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the~     association between serum uric acid level and endothelial dysfunction has not been elucidated~     yet in these patients. Therefore, in this study, the investigators aimed to examine the~     relationship between the uric acid level and the ED in normotensive ADPKD patients with~     preserved renal function.~   "
151024|NCT01589692|"~     In the United States, over 300,000 individuals over age 65 suffer from distal radius~     fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of~     experience treating DRFs, management of elderly DRFs is still controversial. Close reduction~     and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures,~     common in the elderly, often collapse and displace. The three currently applied surgical~     techniques are close reduction and percutaneous pinning, external fixation with or without~     percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence~     indicates that locking plate fixation can permit elderly patients to move their hands and~     wrists much sooner in order to return to self-care activities more quickly. Although these~     outcomes are promising, there is no randomized controlled clinical trial to demonstrate that~     the more invasive, and perhaps more costly, plating technique is superior to the other~     simpler approaches.~      The specific aim of this 24-center randomized controlled trial is to compare outcomes of~     these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim~     is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes~     following treatment by close reduction and casting alone. This clinical trial is the most~     ambitious study in hand surgery by assembling most of the leading centers in North America to~     collect evidence-based data to guide future treatment of this prevalent injury in the growing~     elderly population.~   "
151025|NCT01589679|"~     To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of~     hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.~   "
151026|NCT01589666|"~     This study is a Phase 1, single-center, open-label, ascending dose study which will assess~     the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma~     (Resusix®) in healthy volunteers.~   "
151027|NCT01589653|"~     This trial is conducted in Africa and Asia. The aim of the trial is to compare~     patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in~     type 2 diabetes patients uncontrolled on NPH insulin.~   "
151028|NCT01589640|"~     This is a single center clinical study designed to determine patient satisfaction and the~     effect of the use of artificial tears on tear osmolarity with time after instillation of~     three commercially available artifical tear eye solutions ( Blink Tears, Blink Gel Tears and~     Systane Balance).~   "
151037|NCT01589523|"~     The purpose of this research study is to determine the way (mechanisms) by which your defect~     in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of~     vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your~     vitamin absorption and your liver disease. An investigational therapy is one that not~     approved by the United States Food and Drug Administration (FDA) and is being provided to you~     under an Investigational New Drug application from the FDA.~   "
151038|NCT01589510|"~     A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT.~     All treatment decisions, care and diagnostic procedures provided are at the discretion of the~     participating physicians according to their clinical judgment and the local standard of~     medical care.~   "
151039|NCT01589497|"~     Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are~     very small living agents that are spread by coughing and can be killed by taking TB drugs. To~     kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and~     then two drugs for a further 4 months. During the first 2 months patients take rifampicin,~     isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and~     rifampicin for a further 4 months, making a total of 6 months therapy.~      In A5307 the investigators wanted to test a new combination of drugs to see if the~     investigators could treat TB faster in the future.~      Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few~     days and may not be needed after the first two doses of TB treatment to kill the TB bacteria.~     After that its effects wear off to the point that it may even interfere with the other drugs.~     The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a~     different drug, instead could treat TB faster. This study was the first time that this type~     of regimen without isoniazid had been tested in humans. If the investigators could show that~     isoniazid stops working after a few days, the investigators could then try to see if they~     could possibly make a better tuberculosis treatment in the future.~   "
151040|NCT01589484|"~     Kidney stone disease affects almost 10% of overall population, often requiring a surgical~     intervention. Currently, shock wave lithotripsy is considered a first-line treatment option~     for patients suffering from symptomatic kidney stones smaller than 2.0 cm, providing~     reasonable stone-free rate. Actually, the outcomes from SWL vary largely due to several~     factors including stone burden, stone density, stone-skin distance (SSD), and patient's body~     habitus. Furthermore, the imaging exam modality (i.e. ultrasound versus computed tomography~     scan) performed to assess the presence of residual fragments also impacts on SWL outcome~     analysis.~      We aim to perform a well-controlled prospective evaluation of all variables that may impact~     on fragmentation and clearance of lower pole calculi after SWL. These variables are assessed~     exclusively by a noncontrast computed tomography scan (NCCT), eliminating the necessity of an~     intravenous urography to study renal collecting system anatomy; an imaging exam that is not~     routinely performed anymore for kidney stone patients.~   "
151041|NCT01589471|"~     Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer.~     Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious~     impacts on quality of life in a third of the cases.~      One possible physiopathology hypothesis suggests an ongoing spastic process; different~     mechanisms have been postulated. These include alteration of normal anorectal sensation with~     loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and reduced~     rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy~     or during surgery.~      Current available treatments are often ineffective, highlighting the need for more successful~     management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine release at the~     neuromuscular junction. It is currently used for the treatment of various smooth muscle~     spastic diseases.~      The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical~     treatment alternative for LARS. The goal of this study is to document the effects of~     intra-rectal BTX-A injections on sphincter function and quality of life of patients with~     LARS.~   "
151042|NCT01589458|"~     Considering the widespread use of sodium fluoride (NaF) and monofluorophosphate (MFP) based~     toothpastes, the present study aim to evaluate F availability in saliva after use of the~     top-selling Brazilian toothpastes. In a blind, crossover clinical trial study, volunteers~     will brush their teeth with one of the following toothpastes: 1) non-fluoride toothpaste~     (negative control group); 2) NaF/silica based toothpaste 3)MFP/calcium carbonate based~     toothpaste. After brushing, a rinse with purified water will be performed. Unstimulated~     saliva will be collected before and up to 60 min after brushing. Ionic fluoride and total~     soluble fluoride (corresponding to the sum of fluoride as ion and as MFP) will be determined~     after acid treatment of salivary samples to hydrolyze MFP. Fluoride will be determined using~     an ion selective electrode.~   "
151043|NCT01589445|"~     -  The present study was undertaken to assess the efficacy and safety of two different~          insulin sensitizers (namely Pioglitazone and Metformin) among subjects with type 2~          diabetes mellitus (T2DM) in Bangladesh.~        -  A prospective, double-blind, single group, 'within-subject' designed clinical trial of~          77 diagnosed T2DM patients out of 130 patients with glycosylated haemoglobin (HbA1c)~          ≥7.2±1.5%, aged 46±6.4 years and registered for diabetes treatment in Bangladesh~          Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders~          (BIRDEM) was carried out.~        -  The study was conducted between November 2008 and September 2010.~        -  Baseline data, included case history of the patients,anthropometric measurement,~          biomedical parameters psychosocial factors, were collected from each subject and then~          enrolled to receive treatment with 001 drug once daily for three months, then the~          patients were left for wash out with metformin 850mg once daily for one month; then they~          received 002 drug once daily for further three months.~        -  Dietary chart was remained as before.~        -  DNA was isolated by Chelex method using the primers and control DNA,restriction~          Digestion Enzyme Endonuclease Hae 111 for genotyping PPARγ-(Peroxisome Proliferator~          Activated Receptor gamma)Pro12Pro~             -  (Proline12Proline)/Pro12Ala-(Proline12 Alanine))/Ala12Ala-(Alanine12Alanine).~        -  The blinded drugs were decoded after analyzing results, 001 tablet was pioglitazone (30~          mg once daily) and 002 tablets was metformin (850mg once daily). Bio-medical outcomes~          were measured to assess the efficacy of both the drugs each month. After finishing the~          treatment period the effects of two drugs were compared using SPSS.And the association~          between the pioglitazone drug effects and genetic polymorphism was also assessed.~        -  The metformin effects was assessed also using the response rate of HbA1c <7.0% after 3~          months treatment to the patients.~   "
151044|NCT01589432|"~     People with diabetes can, over time develop nerve damage throughout the body with symptoms~     such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.~   "
151045|NCT01589419|"~     An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the~     PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with~     locally advanced rectal cancer (LARC).~   "
151047|NCT01589393|"~     Victims of trauma with severe head injury who have bled into their brains are at high risk of~     developing blood clots in their legs. These blood clots can break off and travel through the~     bloodstream to the lungs causing death. Blood thinners can be given to patients to prevent~     blood clots from developing but this can leave patients at risk for additional bleeding in~     the brain causing further damage or death. The earlier blood thinners are started the more~     effective they are at preventing blood clots but some patients with severe head injury who~     have bled into their brains will develop further bleeding even if they do not receive blood~     thinners. Even though a growing body of research has shown that the majority of bleeding in~     the brain stops within the first 24 hours after injury and that it is safe to start blood~     thinners as early as 24 hours after injury, doctors are still waiting longer than 4 days to~     start blood thinners in these patients over concerns of worsening bleeding. In Canada, almost~     half of the patients with severe head injury do not receive blood thinners until at least~     five days after injury. Delays in starting blood thinners appear to put patients at increased~     risk of developing blood clots, unnecessarily. This study will compare the benefits of~     starting low-molecular weight heparin (LMWH), a type of blood thinner, early (less than 48~     hours) versus the current practice (waiting until the 5th day after being injured) in~     preventing blood clots in patients who have bled into their brains after severe head injury.~     The investigators believe that starting LMWH earlier will be more effective in preventing~     blood clots without worsening any bleeding when compared to waiting to start blood thinners.~     This study is called OPTTTICH (Optimal Timing of Thromboprophylaxis in Traumatic IntraCranial~     Haemorrhage) and will be the largest Canadian investigator-initiated randomized control trial~     on blood clot prevention in trauma patients with severe head injury who have bled into their~     brains.~   "
151048|NCT01589380|"~     We hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and~     decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse~     LV remodeling favorably in patients with asymptomatic moderate to severe AS.~   "
151049|NCT01589367|"~     Preoperative letrozole versus letrozole with metformin in postmenopausal Estrogen receptor~     positive breast cancer patients~      Phase II multicenter 1:1 randomized clinical trial Total 208 patients~      Primary endpoint Clinical response rate~      Secondary endpoint Pathologic complete response rate Breast conserving surgery rate Percent~     mammographic density change Ki67(%) change after 4week medication of 2nd core needle biopsy~     Toxicity profile of neoadjuvant letrozole, metformin~   "
151050|NCT01589354|"~     This study evaluates two anaesthetic techniques namely interscalene brachial plexus block and~     intra-articular local anaesthetic injection. Both techniques are currently used for providing~     postoperative pain relief following arthroscopic shoulder stabilisation operation. It will be~     a randomised controlled trial involving 30 patients in two groups.~   "
151051|NCT01589341|"~     This research studies chromosomes in samples from younger patients with neuroblastoma.~     Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to cancer.~   "
151052|NCT01589328|"~     Effect of Early management on PAin and DEpression in patients with PancreatoBiliary Cancer,~     EPADE-PB~      Purpose~      To determine whether early palliative care integrated with usual oncologic care with~     automated symptom monitoring can improve depression and pain in patients with cancer~   "
151053|NCT01589315|"~     This pilot, open label investigation evaluates the safety and efficacy of a new form of~     electroconvulsive therapy (ECT). Both the efficacy and adverse cognitive effects of ECT are~     highly contingent on the intracerebral current paths and current density of the ECT stimulus.~     However, the impedance of the skull and individual differences in skull anatomy severely~     limit the spatial targeting of stimulation, and create marked individual differences in~     intracerebral current density. To address these problems, the investigators are exploring~     various means of overcoming this limitation.~      An approach is to modify the electrical stimulus to induce focal seizures. The most common~     methods of ECT administration in the US use a bidirectional, constant current, brief pulse,~     with large (approximately 3 sq. in. surface area) and identically sized and shaped~     electrodes. In contrast, in this protocol the investigators have coupled unidirectional~     current flow with an electrode geometry involving a small and large electrode that differ by~     more than 3:1 in surface area.~      Unidirectional currents were widely used in ECT during the, 1940's and continue to be used in~     European and American devices today. Transcranial electrical stimulation can be made focal by~     stimulating with an anode-cathode arrangement, with the electrodes differing in surface area.~     The investigators have shown in nonhuman primates the capacity to produce focal frontal~     seizure induction under conditions when a unidirectional current flows from a small anterior~     anode (placed on the forehead over the nasion) to a large posterior cathode just anterior to~     the motor strip. Furthermore, the investigators expect that some, if not all, of these~     seizures do not result in motor convulsions.~      Thirty outpatients referred for ECT will participate. Relative to concurrent reference data~     from our ongoing ECT protocols, the investigators hypothesize that acute and subacute adverse~     cognitive effects of FEAST will be substantially less than those in patients receiving~     state-of-the art ECT, but with a traditional bidirectional, nonfocal stimulus. The~     investigators also hypothesize that the majority of patients will remit with FEAST. Thus, by~     improving the efficiency of the ECT stimulus with the switch to unidirectional current and~     the use of a new electrode geometry, the investigators expect to be able to induce focal~     seizures. The investigators hypothesize that this pilot study will provide evidence that this~     treatment is superior to traditional ECT in having lower dosing requirements and a superior~     side effect profile.~   "
151054|NCT01589302|"~     This is a Phase II, single institution open-label, non-randomized monotherapy study to~     evaluate the clinical efficacy and durable disease control of PCI-32765 administered to~     patients with relapsed/refractory CLL/SLL/PLL of all risk categories with patients having~     deletion 17p13 independently evaluated.~   "
151055|NCT01589289|"~     The impact of neurological disorders is enormous worldwide, and it is increased in poor~     settings, due to lack of diagnosis and treatment facilities as well as delayed management. In~     sub-Saharan Africa, the few observational studies conducted for the past 20 years show that~     neurological disorders accounted for 7 to 24% of all admissions. Central nervous system (CNS)~     infections were suspected in one third of all patients admitted with neurological symptoms,~     with a specific microbial aetiology identified in half of these. Most CNS infections may be~     considered as severe and treatable diseases, e.g. human African trypanosomiasis (HAT),~     cerebral malaria, bacterial meningitis, CNS tuberculosis etc. If left untreated, death or~     serious sequels occur (mortality rates were as high as 30% in the above mentioned studies),~     but the outcome may be favourable with timely and appropriate management.~      In poor settings, such conditions should be targeted in priority in the clinical~     decision-making process. Unfortunately, most neuro-infections present with non-specific~     symptoms in their early stages, leading to important diagnostic delays. Moreover, they~     require advanced diagnostic technology, which is not available in most tropical rural~     settings: here, you have to rely on clinical judgment and first-line laboratory results,~     whose confirming or excluding powers are limited or unknown. Several rapid diagnostic tests~     (RDTs) have been recently developed for conditions like malaria or HIV, but their diagnostic~     contribution has not been evaluated within a multi-disease approach.~      Thus, this research aims at improving the early diagnosis of severe and treatable neglected~     and non-neglected infectious diseases which present with neurological symptoms in the~     province of Bandundu, Democratic Republic of Congo (DRC), by combining classic clinical~     predictors with a panel of simple point-of-care rapid diagnostic tests.~      The evaluation of existing algorithms and elaboration/validation of new guidelines will be~     described in a subsequent protocol.~   "
151056|NCT01589276|"~     The aim of present study was to evaluate the clinical course after emergency ventral hernia~     repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk~     factors for emergency repair.~   "
151072|NCT01589068|"~     The proposed clinical studies will analyze the interactions between progesterone, nicotine,~     fMRI measures of patterns of brain activity, covariance with endocrine hormones, mood and~     cardiovascular measures. It is hypothesized that the administration of progesterone at a dose~     that mimics luteal phase levels in normal cycling women will diminish the positive subjective~     effects of nicotine, as has been consistently observed for cocaine. This novel approach could~     have direct implications for facilitating smoking cessation treatment in women of~     reproductive age~   "
151057|NCT01589263|"~     Benign prostatic hyperplasia (BPH) and its related symptoms are a common condition that~     affects nearly half of men over age 50 and 90% of men over 80. Lower urinary tract symptoms~     (LUTS) caused by BPH can be very troublesome, affect an individual's quality of life~     significantly, and are costly.~      his Phase 2 clinical research trial is a double-blind, randomized, placebo-controlled,~     parallel-group study to compare the treatment effects of onaBoNT-A 200 U versus 0.4 mg per~     day of oral tamsulosin in male Veterans diagnosed with moderate to severe LUTS [American~     Urologic Association Symptom Score (AUASS) equal to or greater than 8] associated with BPH. A~     total of 74 volunteers will be recruited to participate in this clinical trial. Volunteers~     will include only males who are greater than 50 years of age and diagnosed with LUTS~     associated with BPH. They are Veterans who visit the Michael E. DeBakey Veterans Affairs~     Medical Center - Houston (MEDVAMC). There are no eligibility restrictions as to race or~     ethnicity.~   "
151058|NCT01589250|"~     Use of risk scoring systems in the assessment of patients presenting with upper~     gastrointestinal haemorrhage is increasing. Comparative studies have intended to identify the~     system of choice, but the majority of these are characterized by retrospective designs, small~     sample sizes, low rate of severe bleeding, or low mortality. The main aim of this study was~     to identify the optimal scoring system.~   "
151059|NCT01589237|"~     This study was to determine long-term safety and tolerability, and continued efficacy in~     lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS)~     (HLP type I).~   "
151060|NCT01589224|"~     Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality~     for the coronary artery disease. Recently, novel adipokines and hepatokines as well as~     various inflammatory markers have been known as direct regulators of atherosclerosis.~     Therefore, the investigators examine the correlation of various metabolic risk factors~     including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT~     in apparently healthy people.~   "
151061|NCT01589211|"~     To investigate the effectiveness of a smoking cessation intervention of two sessions (120 min~     at a time) in a group setting on the basis of Motivational Interviewing (MI) and important~     elements of Cognitive Behavioural Therapy (CBT). According to national and international~     guidelines patients are advised to quit and pharmacologically supported with one of the~     established first line smoking cessation treatments.~   "
151062|NCT01589198|"~     The purpose of this study is to learn more about asthma in people who are not well-controlled~     with current asthma medication (refractory asthma). The investigators will compare data from~     refractory asthmatic patients here at National Jewish Health to mild asthmatics subjects and~     to people without asthma. Study experiments involve looking at samples from all 3 groups and~     comparing them at a molecular level. These laboratory experiments may help identify subtypes~     of refractory asthmatics that require different treatments.~   "
151063|NCT01589185|"~     The objectives of this study are to assess the safety, tolerability, pharmacokinetics,~     pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by~     Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in~     addition of standard of care antibiotic treatment.~   "
151064|NCT01589172|"~     The investigators will obtain thromboelastography (TEG) on pediatric patients admitted to the~     Rady Children's Hospital ICU after traumatic brain injury on admission to our ICU and after~     24 hours of care. The investigators hypothesize that TEG will identify abnormalities of~     coagulation that are not identified by traditional coagulation studies, i.e. prothrombin time~     (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR).~   "
151065|NCT01589159|"~     This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and~     safety study. Eligible patients are enrolled in a single group. The investigators propose to~     determine the efficacy and safety of low-dose metronomic chemotherapy with~     Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with~     Anthracyclines and/or Taxanes.~   "
151066|NCT01589146|"~     Overall, only limited evidence exists regarding the clinical benefit of antithrombotic~     prophylaxis after laparoscopic surgery for cancer. Four studies reported on the incidence of~     venous thromboembolism (VTE) after laparoscopic surgery for cancer. These studies differ~     concerning study design, site of cancer, regimens for antithrombotic prophylaxis and reported~     incidence of VTE.~      The aim of this multicenter, randomized study is to assess the clinical benefit of extended~     (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for~     colorectal cancer.~   "
151067|NCT01589133|"~     The purpose of this study is to assess the consistency of the results of irregular antibody~     screening with Surgiscreen （investigational reagent) and Serascan Diana 3 (control reagent),~     and the consistency of the results of irregular antibody screening with investigational~     reagent on serum and plasma from same patients.~   "
151068|NCT01589120|"~     The purpose of this study is to compare the decision making of subjects with advanced CHF~     having a verbal discussion about goals of care compared to subjects using a video.~   "
151069|NCT01589107|"~     To demonstrate that clinical surrogates of SICU patients who view a video decision aid in~     addition to receiving written and verbal information about procedures and life sustaining~     therapy in the SICU make more informed decisions than patients and clinical surrogates who~     receive written and verbal information alone.~   "
151070|NCT01589094|"~     The purpose of this study is to find out if standard chemotherapy (gemcitabine and cisplatin)~     given on a dose-dense treatment schedule (with less time between treatments) can help shrink~     the tumor better than standard chemotherapy given on a standard treatment schedule before the~     patient undergoes surgery for bladder cancer.~   "
151071|NCT01589081|"~     The proposed clinical studies will analyze the interactions between progesterone, nicotine,~     alterations in endocrine hormones, mood and cardiovascular measures. It is hypothesized that~     the administration of progesterone at a dose that mimics luteal phase levels in normal~     cycling women will diminish the positive subjective effects of nicotine, as has been~     consistently observed for cocaine. This novel approach could have direct implications for~     facilitating smoking cessation treatment in women of reproductive age~   "
151095|NCT01588769|"~     It is the primary objective of this study to show safety and tolerability for administration~     of the cell based immunotherapy ALECSAT to patients with Glioblastoma brain cancer. It is a~     secondary objective to establish if any indications of positive therapeutic or palliative~     effects may be observed.~   "
151073|NCT01589055|"~     Clinical studies are proposed to analyze the interactions between nicotine, alterations in~     endocrine hormones, mood and cardiovascular measures. The studies are designed to examine the~     contribution of gender and menstrual cycle phase. It is hypothesized that analysis of~     nicotine's rapid hormonal, cardiovascular and subjective effects will be important for~     developing novel biologic approaches to treatment for nicotine abuse and dependence as well~     as advancing understanding of the neurobiology of nicotine reinforcement.~   "
151074|NCT01589042|"~     To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the~     effectiveness of the device for use during percutaneous transluminal angioplasty (PTA)~     procedures.~   "
151075|NCT01589029|"~     The pilot study evaluates the efficacy and safety of Canakinumab (ILARIS®) in subjects with~     proliferative diabetic retinopathy secondary to type 1 and 2 diabetes. Ten subjects will be~     enrolled to receive 150 mg Canakinumab (ILARIS®) by subcutaneous injection. Beginning on day~     0, each subject will receive a subcutaneous injection of study drug every 8 weeks for 16~     weeks, a total of 3 injections. All subjects will undergo regular follow-up assessments every~     8 weeks through 24 weeks. Fluorescein angiography (FA) is repeated every 8 weeks. In case of~     progression of retinal neovascularization on FA panretinal laser photocoagulation is~     administered as rescue therapy. The primary outcome is the regression of retinal~     neovascularizations (NVE and NVD) in FA at 24 weeks. In addition to key secondary outcomes~     including regression of diabetic macular edema, change in best-corrected visual acuity,~     change in HbA1c levels and change in markers of systemic inflammation. Safety will be~     assessed by measurements of vital signs, clinical laboratory assessments, and the recording~     of adverse clinical events.~   "
151076|NCT01589016|"~     The purpose of this study is to determine the predictive value of a single serum~     determination of activin A and inhibin A for the prognosis of ectopic pregnancy after in~     Vitro Fertilization (IVF) cycles, in both native and donated oocytes.~   "
151077|NCT01589003|"~     The current study proposes to investigate the impact of a low glycaemic index (GI), fortified~     toddlers milkpowder on mood, behaviour and cognitive function in young children.~   "
151078|NCT01588990|"~     This open-label, prospective, single-arm, multicenter study will evaluate the relationship of~     the markers of inflammation and progression-free survival (PFS) in participants with~     previously untreated metastatic colorectal cancer. The study consists of two phases: Phase A~     treatment: oral capecitabine plus infusional oxaliplatin (XELOX) plus bevacizumab, or~     modified infusional 5-fluorouracil (5-FU), Leucovorin (LV) and oxaliplatin (mFOLFOX6) plus~     bevacizmab administered until first disease progression. Participants will then continue with~     Phase B treatment: infusional 5-FU, LV and irinotecan (FOLFIRI) plus bevacizumab until second~     disease progression. The anticipated time on study treatment is 4 years.~   "
151079|NCT01588977|"~     The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The~     creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study~     demonstrated tibial subchondral microfractures in the group antegrade tibial tunnel unlike~     group retrograde tibial tunnel. To our knowledge, no clinical evaluation was performed. The~     investigators hypothesize that retrograde drilling will cause less local bone injury than~     antegrade drilling in creation of the tibial tunnel for ACL reconstruction.~   "
151080|NCT01588964|"~     In patient with a platinum sensitive ovarian cancer recurrence is demonstrated that the~     re-challenge with a compound of platinum-based, or a treatment with carboplatin in~     combination with paclitaxel , determines a rate of clinical response similar to the primary~     treatment, which is all the more important as the longer the time to progression from the~     primary therapy.In the clinical setting there are many studies that have shown activity of~     oxaliplatin and docetaxel in patients with advanced ovarian cancer. Two recent studies have~     shown clinical efficacy of the combination carboplatin / docetaxel in the first line~     oxaliplatin / paclitaxel to recurrence of disease, confirming the data already obtained from~     studies of activity in a single agent.In surgery it has been demonstrated in a meta-analysis~     including approximately 7000 patients in advanced stages of disease, that the extent of~     cytoreduction is the most powerful determinant of survival.The role of secondary surgical~     cytoreduction in case of recurrent disease has yet to be determined because of the lack of~     prospective randomized clinical studies that may highlight the superiority of such aggressive~     treatment.The combination of aggressive cytoreductive surgery and hyperthermic~     intraperitoneal intraoperative chemotherapy (CHIP) used in recent clinical studies showed a~     prolonged time to progression and disease-free survival in patients with ovarian cancer.~     However, these studies were conducted on groups of patients with very different among~     themselves and with other drugs, it is difficult to draw definitive conclusions.Given the~     activities of oxaliplatin and docetaxel and their non-cross-resistance we designed a Phase 2~     clinical trial on treatment of patients with recurrent ovarian cancer, platinum-sensitive,~     treated with surgical cytoreduction with hyperthermic oxaliplatin-based intraoperative~     intraperitoneal chemotherapy and following consolidation treatment with oxaliplatin and~     docetaxel systemically every 21 days.~   "
151081|NCT01588951|"~     The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of~     patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to~     the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission~     (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell~     transplantation (SCT).~   "
151082|NCT01588938|"~     This prospective study at MAMC evaluates the utility of a rigid pelvic external~     immobilization compared to limited immobilization using a novel real-time localization system~     of the prostate. The sample population will include patients referred to the radiation~     oncology services of both facilities for definitive treatment of prostate cancer. The study~     will enroll 20 subjects from MAMC and evaluate data on 860 radiation therapy fractions.~      Subjects will have Beacon® Transponders implanted into the prostate to more precisely~     localize the position of the organ during radiation therapy. They will be randomized to rigid~     pelvic immobilization using a Vac-Lok® system or limited immobilization with a band around~     the patient's feet. They will then undergo radiation therapy planning with standard planning~     target margins. The Calypso® 4D Localization System will monitor, in real time, the position~     of the prostate target and adjust radiation treatments as required to ensure accurate~     treatment of the prostate gland. The time of, the number, and extent of adjustments will be~     recorded for analysis.~      Hypothesis: 1. When treating only the prostate, treatment with rigid pelvic immobilization is~     not necessary when using real-time, state-of-the-art motion tracking of the prostate.~   "
151083|NCT01588925|"~     The objective of the present study is to investigate the effect dexamethasone and hyaluronic~     acid have on hearing preservation~   "
151096|NCT01588756|"~     The purpose of the study is to validate a new reference marker for evaluation of renal~     function (glomerular filtration rate).~   "
151113|NCT01588509|"~     The purpose of this study is to estimate the percent change from baseline in lumbar spine~     bone mineral density (BMD) following multiple-dose administrations of romosozumab in~     postmenopausal women with low BMD previously treated with alendronate.~   "
151084|NCT01588912|"~     Oral antiviral drugs which can be given to patients with HBeAg-positive chronic hepatitis B~     include Lamivudine, Clevudine, Adefovir, Telbivudine, Entecavir and Tenofovir. 2009 American~     Association for the Study of Liver Disease (AASLD) Treatment Guidelines and 2009 European~     association for the Study of the Liver (EASL) Treatment Guidelines recommend the~     administration of Entecavir or Tenofovir with high potency and low resistance. Lamivudine has~     low antiviral potency and high incidence of mutation in long-term administration compared to~     Entecavir or Tenofovir. Clevudine causes the elevated creatinine kinase (CK), side effects~     including myositis/myopathy and much mutation in the long-term administration. Globe study~     demonstrated Telbivudine had more excellent antiviral potency than Lamivudine, which was also~     comparable to or higher than Entecavir or Tenofovir. Nevertheless, the choice of treatment~     drugs can be limited due to the mutation rate of 25% for 2 years. However, the analysis of~     Globe study results showed that 2-year treatment progress was very good in patient who showed~     virologic response at 24 weeks after the initiation of treatment and that high antiviral~     potency and low mutation rate were observed when the Telbivudine roadmap strategy (in the~     event that virologic response is shown at 24 weeks, telbivudine monotherapy is maintained and~     in the event that virologic response is not shown, tenofovir add-on therapy is done) recently~     implemented and announced in 2011 Asian Pacific Association for the Study of the Liver~     (APASL) was applied. However, the study was single arm study, which restricted the comparison~     between Entecavir and Tenofovir monotherapy groups. Therefore, this study intends to compare~     the anti-viral effect and mutation rate between Entecavir 0.5mg monotherapy group and~     Telbivudine roadmap strategy group in patients with HBeAg-positive chronic hepatitis B~     through a randomized study.~   "
151085|NCT01588899|"~     The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve~     Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment~     of uterine fibroids in a Chinese population.~   "
151086|NCT01588886|"~     Chronic kidney disease is a severe medical problem in Taiwan public health issue, which the~     highest incidence and prevalence rate in the world.Proton pump inhibitors may increase the~     risk of pneumonia appearance, which were caused by profound irreversible gastric acid~     suppression. The study purpose was to characterize difference of developing pneumonia in~     chronic kidney disease of prior use proton pump inhibitors.~   "
151087|NCT01588873|"~     The main aims of this study are:~        -  to investigate and compare the effects of long lasting use (59 weeks) of vaginal and~          oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid~          profile, and serum levels of SHBG and hs-CRP in women with PCOS.~        -  to compare the metabolic effects of oral and vaginal combined contraceptives and to find~          out whether oral or transvaginal contraceptive can be recommended to a particular group~          of women, for example in women with increased metabolic risks.~        -  to clarify whether the unfavourable effects of combined contraceptives diminish with~          time (after use of one year).~   "
151088|NCT01588860|"~     Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and~     constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High~     prevalence in southeast and eastern Asia has been observed. At present, the cellular and~     molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear.~      The RAS gene product has a key role in controlling cell growth and differentiation through~     its intrinsic GTPase activity. Point mutations that activate the RAS protein and its~     downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the~     RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals.~     Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer~     and lung cancer. Studies from European and Japanese groups have recently described that~     activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma~     of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF~     mutation in the same tumor as well as the results from Thailand. In this study, the~     investigators hypothesize copy number changes rather than genetic mutation of either KRAS or~     BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary~     tracts.~   "
151089|NCT01588847|"~     Studies in animals and retrospective studies in humans show that regional anesthesia reduces~     metastatic cancer dissemination.~      The investigators hypothesize that in patients suffering from malignant melanoma who have to~     undergo radical inguinal lymph node dissection immune function will be less compromised and~     long term survival will be superior when spinal anesthesia is compared to general anesthesia.~   "
151090|NCT01588834|"~     The investigators hypothesize that knowledge of the functional behavior of areas of~     mammographic density will enable more specific identification of dense tissue at-risk for~     breast cancer, ultimately providing predictive information on an individual's risk of~     developing breast cancer.~   "
151091|NCT01588821|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA has not approved the drug for this type of cancer, or for~     any use outside of research studies.~      When cancer spreads from the primary tumor, one of the most commons sites it spreads to is~     bone. When cancer spreads to bone there can be significant symptoms such as pain.~      Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the~     growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been~     studied or is being studied in research studies as a possible treatment for various types of~     cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney~     cancer.~      Previous clinical research studies indicate that cabozantinib may also have activity against~     cancer once it has spread to the bones.~      The purpose of this study is to find out if cabozantinib is effective in treating cancer that~     has spread to the bone.~   "
151092|NCT01588808|"~     In the present study, the effects of 5 days of lower limb immobilization with or without~     twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be~     determined. A young group will be included to compare the changes in muscle mass and muscle~     fiber characteristics between young and old men.~   "
151093|NCT01588795|"~     The DERENEDIAB study is a proof-of-concept, multi-center, prospective, open, randomized,~     controlled study of the effectiveness of renal denervation in addition to standardized~     medical treatment compared to medical treatment alone in diabetic subjects with diabetic~     nephropathy and resistant proteinuria. Bilateral renal denervation will be performed using~     the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy~     through the luminal surface of the renal artery.~   "
151094|NCT01588782|"~     The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for~     drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is~     co-administered with abiraterone acetate in healthy adult men.~   "
151097|NCT01588743|"~     It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to~     impairment in islet β-cell function and development of insulin resistance. A growing body of~     evidence also indicates that this impairment inβ-cell function and insulin action could be~     restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this~     study, we are determined to use the golden standard of insulin sensitivity evaluation in~     vivo—hyperinsulinemia euglycemic glucose clamp—to estimate insulin resistance improvement in~     patients before and after intensive insulin therapy, investigate first phase insulin~     secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin~     secretion resulting from normalization of plasma glucose levels in both lean and obese~     patients by insulin pump therapy.~   "
151098|NCT01588730|"~     The purpose of this study is to compare the Ankle Dorsiflexion Dynasplint System (DS) to~     static night splint for the reduction of pain from Plantar Fasciitis (Fasciopathy).~   "
151099|NCT01588717|"~     The study consists of measurement of antidepressant-induced excessive sweating and its~     treatment with an experimental medication, glycopyrrolate (approved to treat ulcers), which~     will be added to the antidepressant. This is an open-label study (no placebo group or~     concealment of the nature of the treatment) that will last 8 weeks, including two weeks of~     baseline measurement without treatment with the study medication followed by six weeks of~     treatment with the study medication. The study is pilot study by Dr. Rajnish Mago that is~     based on the hypothesis that glycopyrrolate will be effective in reducing the severity of~     excessive sweating caused by antidepressant treatment, and will have minimal side-effects.~   "
151100|NCT01588704|"~     The prognosis of patients with unresectable, locally advanced non-small cell lung cancer~     (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer~     drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern~     targeted therapies have enhanced the outcomes of lung cancer treatment, especially for~     advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is~     bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF).~     Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy~     may change the previous treatment modality. It allows some lung cancer patients to be~     downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be~     improved.~   "
151101|NCT01588691|"~     Peripheral nerve stimulation for the treatment of sequelae due to traumatic brain injury.~     This study will specifically examine patients with mild traumatic brain injury (TBI) who have~     persistent cognitive impairments lasting one year or longer. Neuropsychological testing will~     occur to confirm the diagnosis.~   "
151102|NCT01588678|"~     DS-3078a will be evaluated as a single agent in subjects with advanced solid tumor~     malignancies or lymphomas refractory to standard treatment or for which no standard treatment~     is available.~   "
151103|NCT01588665|"~     The two specific aims of this study are 1) to assess the relative contributions of two major~     maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron to~     the fetus, and 2) to determine the impact of maternal and fetal iron status on placental~     transfer of these two iron sources in pregnant women and adolescents during the last~     trimester of pregnancy.~   "
151104|NCT01588639|"~     This is a prospective, multi-center, open-label, non-interventional, 12-week study in people~     with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin~     R and SciLin M30 (alone or in combination) in routine clinical practice. The term study~     insulins will be used in this protocol for these drugs and combinations.~   "
151105|NCT01588626|"~     The purpose of this study is to assess the pharmacokinetics of AZD6140 and its active~     metabolite, safety, tolerability of AZD6140 following single administration in healthy male~     Japanese volunteers.~   "
151106|NCT01588600|"~     The effects of a dietary fiber on hunger and food intake will be tested in men and women.~     Participants will receive fiber as part of a breakfast meal on two occasions. On another~     occasion, participants will receive the same breakfast, without added fiber. Their feelings~     of hunger and fullness will be measured over the day. They will be offered lunch, dinner and~     an evening snack and how much they eat will be recorded. It is expected that the fiber~     supplement will enhance their feelings of satiety and reduce the amount they eat over the~     day.~   "
151107|NCT01588587|"~     Recently, DPP-IV inhibitors are used as a novel way to augment the incretin system and one of~     the newest classes of medications in the treatment of type 2 diabetes mellitus (T2DM). Since~     the DPP-IV inhibitor was first used, about 5 years have passed in USA. However, there were no~     major side effects including occurrence of cancers. The main mechanism for DPP-IV inhibitors~     is due to suppress the function of DPP-IV activity. As it is known that the suppressed DPP-IV~     activity is a marker for early diagnosis of cancers, the reason of disassociation is not~     clear.~      Activation of receptor for advanced glycation endproduct (AGE) is related to sideration of~     cancers. Meanwhile, the DPP-IV inhibitors may be related to inhibit the activation of~     receptor for AGE (RAGE). Therefore, DPP-IV inhibitors may work as a cancer protective agent~     in diabetes by blocking the AGE-RAGE axis.~      However, it is not demonstrated why DPP-IV inhibitors have no side effect of occurrence of~     cancer via blocking the activation of AGE-RAGE.~      The investigators examined effect of DPP-IV inhibitors on frequency of cancers and the~     underlying mechanism using AGE and RAGE before and 5 years after administration of DPP-IV~     inhibitors in Japanese patients with T2DM.~   "
151108|NCT01588574|"~     The purpose of this study is to determine the Optimal dose for safety and efficacy in the~     treatment of cervical dystonia.~   "
151109|NCT01588561|"~     In this study, we sought to explore brain activity in nicotine-dependent men in response to~     acute intravenous nicotine using pharmacological magnetic resonance imaging (phMRI).~   "
151110|NCT01588548|"~     The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a~     maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when~     given daily to patients with advanced solid malignancies including malignant lymphoma~   "
151111|NCT01588535|"~     This study is to assess the reliability and validity of the FAECC scale to evaluate pain~     associated with acute otitis media in children aged 2 months to 5 years.~   "
151114|NCT01588496|"~     A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in~     patients with homozygous familial hypercholesterolemia (HoFH).~   "
151115|NCT01588483|"~     Giant cell arteritis (GCA) is the most frequent vasculitis in patients above 50 years of age.~     The disease has limited mortality, mostly due to the development of aortic aneurysms, leading~     to dissection and rupture. The probability to develop this complication is 17 x higher at the~     level of the thoracic aorta and 2,4 x at the level of the abdominal aorta in patients with~     GCA when compared with a control group. Therefore, follow-up of the aortic diameter in~     patients with GCA is part of good clinical practice. Previous retrospective research showed a~     link between FDG-uptake at the level of the thoracic aorta, on positron-emission-tomography~     (PET) at the time of diagnosis, and the increase of diameter and volume of the thoracic aorta~     during follow-up (on computed tomography (CT)).~      The purpose of this prospective study is to follow-up on the aortic diameter, and to~     correlate these measures with FDG-PET uptake at diagnosis. Ideally, this would allow us to~     define a group of patients at high risk to develop an aortic aneurysm, already at the time of~     diagnosis.~   "
151116|NCT01588470|"~     The purpose of this study is to examine the existence of heart abnormalities in patients with~     diabetes and the effect of pioglitazone in correcting these abnormalities.~   "
151117|NCT01588457|"~     The purpose of this study is to compare which of the two mood stabilizers (drugs that help to~     steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is~     more effective in patients with bipolar disorder over 26 weeks. The study will also compare~     if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus~     lithium or divalproex used with lamotrigine is more effective when symptoms of depression~     develop.~   "
151118|NCT01588444|"~     The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft~     (FDBA) materials in the preservation of alveolar bone following extraction of non-molar~     teeth. The primary objective is to histologically evaluate and compare the healing of~     extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for~     ridge preservation.~   "
151119|NCT01588431|"~     Locally advanced squamous cell carcinoma of the head and neck (SCCHN) is treated with various~     combinations of radiation and chemotherapy. This study aims to evaluate the rate of complete~     responses with induction therapy (primary endpoint) and progression-free survival, overall~     survival and objective response rates of docetaxel, cisplatin, cetuximab, and bevacizumab~     (TPE-A) followed by radiation therapy, cisplatin, cetuximab, and bevacizumab (XPE-A). Also,~     the investigators plan to investigate a panel of EGFR and angiogenesis biomarkers in pre-and~     post- treatment tumor biopsies. Finally, the investigators will evaluate the associated~     treatment toxicities and the quality of life.~   "
151120|NCT01588418|"~     This research study will examine brain glucose metabolism after an overnight fast to~     determine the effect of exenatide on brain glucose metabolism and lipid metabolism.~   "
151121|NCT01588405|"~     This multi-center, open-label study will assess the tolerability and safety of transitioning~     subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV)~     or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR)~     tablets).~      This study will consist of an in-hospital transition phase, dose optimization/evaluation~     phase, and follow up phase.~   "
151122|NCT01588392|"~     The purpose of this study is to examine if short bouts of structured physical activity~     implemented within the classroom setting as part of designated gross-motor playtime will~     increase preschool-age children during-school physical activity level.~   "
151123|NCT01588379|"~     The purpose of this study is to examine the feasibility and efficacy of a 12-week afterschool~     afro-centric dance physical activity program for daughters and mothers on the physical~     activity level of African-American girls.~   "
151124|NCT01588366|"~     This is a study that involves multiple doses of study drug (60 mg of LY2409021, 15 mg of~     LY2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. This study~     will image the liver using magnetic resonance imaging (MRI) and magnetic resonance~     spectroscopy (MRS) in healthy participants and in participants with type 2 diabetes mellitus,~     when they take LY2409021 to see if liver changes happen at the same time as changes in blood~     tests. This study is approximately 11 weeks long, not including screening. A screening~     appointment is required within 28 days prior to the start of the study.~   "
151125|NCT01588353|"~     To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture.~      To determine plasma concentration after the first injection of AK160 in patients with~     Dupuytren's Contracture.~   "
151126|NCT01588340|"~     The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring~     sedation to ultrasound in the assessment of hydronephrosis.~   "
151127|NCT01588327|"~     The ability to explain bleeding or clotting complications in patients treated with dabigatran~     remains challenging. In addition, there is limited data on how coagulation tests perform in~     patients treated with therapeutic doses of dabigatran. Predicted responses of coagulation~     tests to therapeutic doses of dabigatran may be helpful in better understanding abnormal~     responses to dabigatran. The purpose of the study is to define a therapeutic reference range~     for peak and trough coagulation tests in patients taking FDA approved doses of dabigatran and~     to determine which tests may be most clinically useful for monitoring dabigatran.~   "
151128|NCT01588314|"~     The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling~     peripheral neuropathic pain in patients with Fabry disease, and reducing their use of opioid~     analgesics. The investigators are conducting a randomized, double-blind, placebo controlled,~     single center, cross-over study. The primary endpoint is percent reduction in patients' use~     of hydrocodone-acetaminophen.~   "
151151|NCT01588002|"~     This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study~     will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose~     ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple~     oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all~     subjects will receive multiple oral doses of the combination danoprevir with ritonavir and~     efavirenz for 14 days. Anticipated time on study treatment is 28 days.~   "
151155|NCT01587950|"~     A randomized, controlled, double blind exploratory study to explore the effects of two~     different potassium nitrate concentrations and water on exposed dentine in reducing dentinal~     hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by~     visual analogue scale (VAS) scores following evaporative (air) stimulus.~   "
151129|NCT01588301|"~     Scientific Context:~      High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer.~     Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's~     well-known that this test has significantly contributed to the reduction of mortality and~     morbidity due to cervical cancer. In France, it now seems that the screening strategy could~     be optimized. The two main ways are to reach the 7 million underscreened women (organized~     screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA~     testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA~     testing could be a relevant screening option: this technique appears reliable and it could~     allow to reach women who are never or seldom screened. The performance of the SCVS to detect~     cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.~      The goal of this study is to compare the attitudes of women not attending organized cervical~     cancer screening face to different strategies: further invitation to make a cervical smear or~     kit for self-collected vaginal sample sent at home.~      Description of the project :~      Nine months after a primary invitation to make a cervical smear, a random sample of 6000~     women not attending organized cervical cancer screening will be randomly assigned to one of~     the following arms:~        -  Intervention arm 1:~      Women will receive a further invitation to make a cervical smear~        -  Intervention arm 2:~      Women will be directly sent the kit for self-collected vaginal sample at home. The women who~     will send the self-sample to the laboratory for analyse will receive their results at home as~     well as their general practitioner if the HPV DNA test is positive (infection by a high-risk~     HPV).~      For them who will have a HPV DNA test positive, it will be necessary to complete the~     screening action with a cervical smear. That's why those women will receive an invitation to~     make a cervical smear if they won't do it during the 9 months following the first mail.~        -  Control arm: Those women will receive complete information about the study, the main~          results and the screening recommendations at the end of the study.~   "
151130|NCT01588288|"~     The investigators will dose galectin 3 in plasma and water rinse of the needle aspiration~     biopsy in patients with thyroid nodules. The investigators aim to show that preoperative~     dosage of the galectin 3 could provide good diagnosis of malignant versus benign thyroid~     cancer.~   "
151131|NCT01588275|"~     The purpose of this study is to compare the cost-effectiveness and effectiveness of~     mandibular repositioning appliance (MRA) versus Continuous positive airway pressure (CPAP)~     therapy in patients with moderate Obstructive Sleep Apnea Syndrome (OSAS).~   "
151132|NCT01588262|"~     A life threatening disease such as cancer may lead to post traumatic stress disorder, and~     even when reporting low levels of side-effects from cancer disease and treatment, 80% report~     high levels of stress symptoms. The purpose of the present randomised controlled trial is to~     examine the psychosocial effects of a stress management intervention based on cognitive~     behaviour therapy and with focus on increased physical activity in patients with various~     cancer diagnoses using a stepped-care approach. When using a stepped-care approach it is~     possible to study the level and intensity of stress management intervention required to~     achieve increased well-being. A cost-utility analysis will also be performed. 300 adult~     patients with a recent diagnosis of breast-, colorectal- prostate, testicular cancer or~     lymphoma and scheduled for adjuvant and/or curative oncologic treatment at Haukeland~     University Hospital, will be consecutively included in the prospective intervention study.~     The patients will be randomized to intervention or control. In step 1, all patients in the~     intervention group (I-a) will receive 2 counselling sessions. Patients who report clinically~     significant levels of stress, such as intrusive thoughts/avoidance behaviour (measured by~     Impact of Event Scale) and/or worry and depressions (measured by Hospital and Depression~     Scale) will be included in Step 2 (I-b) and include another 4-7 counselling sessions. There~     will also be a focus on motivating to increase physical activity level. Both the intervention~     (I) and control group (C) are allowed to take part in the common rehabilitation program with~     patient education and physical training. Data will be collected with self-reported~     standardized questionnaires. Objectively measures of physical activity level, sleep and daily~     energy expenditure are recorded with SenseWear™ Pro3 Armband. Measure point is at inclusion~     and than after 6 week, 4, 8, 12 and 24 month.~   "
151133|NCT01588249|"~     Cough is a frequent symptom in children and infants and is one of the most common reasons~     parents visit a healthcare provider for their child. The US Food and Drug Administration has~     issued a warning that over-the-counter cough and cold medicines including antihistamines,~     decongestants, anti-tussives, and expectorants should not be administered to children younger~     than 2 years of age due not only to lack of proven efficacy, but also because of important~     safety concerns. A product that has been used in alternative medicine for cough is maple~     syrup. Although no studies have formally evaluated the use of maple syrup for nocturnal cough~     associated with URI, the demulcent effect of maple syrup may provide some relief from cough~     in children. A novel formulation of pasteurized maple cough syrup, when compared to placebo,~     should provide superior relief on nocturnal cough and the sleep difficulty associated with~     URI in children under 12 months and sleep difficulty of their parent/caregiver.~   "
151134|NCT01588236|"~     The purpose of this study is to further assess the efficacy, safety and dose-response of~     KYG0395 in the treatment of primary dysmenorrhea.~   "
151135|NCT01588223|"~     The purpose of this study is to determine a lipidomic profile on the endometrial fluid, that~     can predict endometrial receptivity.~   "
151136|NCT01588210|"~     The hypothesis of this study is that the concentration of fluoride in oral interproximal~     fluids would increase more after using high-viscosity GIC as pit and fissure sealant,~     compared to Resin-Based sealants containing fluoride and RB sealants without fluoride~     content. To validate this hypothesis a randomized clinical trial was designed and performed~     in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after~     the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing~     fluoride and RB sealants without fluoride content.~   "
151137|NCT01588197|"~     The purpose of this study is to determine whether real-time functional magnetic resonance~     imaging may be a viable treatment for chronic pain in the future.~   "
151138|NCT01588184|"~     This single-arm, open-label, multicenter extension study will provide continued bevacizumab~     therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech~     sponsored study and who derived benefit from the bevacizumab therapy. Participants will~     receive the same dose and regimen of bevacizumab as used in the previous parent trial and~     continue this treatment until progression of disease or unacceptable toxicity, withdrawal of~     consent or death whichever occurs first.~   "
151139|NCT01588171|"~     The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH~     (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for~     venous thrombosis.~   "
151152|NCT01587989|"~     This multicenter study with a randomized, double-blind, parallel-group phase will evaluate~     the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate~     versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis,~     with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg~     intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients~     with a good/moderate EULAR response will then be randomized to receive either~     RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12~     weeks. Anticipated time on study treatment is 6 months.~   "
151153|NCT01587976|"~     The purpose of this trial is to study health related quality of life (HQoL)after resection of~     colorectal liver metastases combined with perioperative chemotherapy. The investigators want~     to study if an aggressive, life prolonging and multimodal treatment can be defended from a~     quality of life perspective.~   "
151140|NCT01588158|"~     Adequate pain relief has been a priority of the Joint Commission and is featured on national~     inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction~     with pain relief in the United States, a great deal of emphasis has been placed on opioid~     pain medications. Some of this emphasis on opioid pain medication is driven by the~     pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry.~      There is evidence that the pain is the fifth vital sign campaign of the Joint Commission~     led to an increased incidence of prescription of opioids, but there is less evidence of~     improved satisfaction with pain relief. There is some evidence of an increase in~     opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has~     the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the~     Emergency Department for opioid overdose doubled between 2004 and 2008.~      Patients in other countries take far less opioid pain medication and are equally satisfied~     with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch~     patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and~     have comparable or better satisfaction with pain relief than American patients, most of whom~     take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch~     patients do not feel their pain is undertreated. A study of morphine use after a femur~     fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg~     versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological~     differences are striking and suggest strongly that personal factors may be the most important~     determinant of satisfaction with pain relief.~      It is our impression that most American hand surgeons give patients a prescription for an~     opioid pain medication after carpal tunnel release, and that is certainly true in our~     practice. This seems to be based primarily on the outliers, and intended to avoid~     confrontation with patients that desire opioids; however, most patients take little or no~     narcotic pain medication, and many who do use the opioids complain of the side effects—nausea~     and pruritis in particular. It is therefore not clear whether routine opioids is the optimal~     pain management strategy after carpal tunnel release. In the study of Stahl et al. from~     Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel~     release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen~     or other pain medication at all after the operation.~      Our aim is to determine if there is a difference in satisfaction with pain relief between~     patients advised to take opioids compared to patients advised to use over the counter~     acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to~     determine if personal factors account for more of the variability in satisfaction with pain~     relief than opioid strategy.~   "
151141|NCT01588145|"~     The main objective of this study is to evaluate the safety and tolerability of HM61713.~   "
151142|NCT01588132|"~     In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of~     Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical~     evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and~     low bleeding potential in healthy human subjects.~   "
151143|NCT01588119|"~     Patients, who are adjusted to a new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban,~     Edoxaban) in routine treatment will recorded in this register. Within this register a~     characterization of patients (with regard to demography and indication) and therapy (with~     regard to medication, dose and duration) will be done. On basis of defined clinical relevant~     end points the long-term efficacy and safety will be evaluated.~   "
151144|NCT01588106|"~     The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with~     AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE)~     enables behavioral changes that may lead to improvement in glycemic control, expressed as a~     reduction in HbA1c as primary endpoint.~      Patients will be randomized either to using CONTOUR Next USB or CONTOUR. Patients will be~     trained in using the devices and return every 3 months until month 9 after baseline.~   "
151145|NCT01588093|"~     Hormonal disturbances in the GH-IGF-I axis are considered important for the deterioration of~     glycemic control in T1DM particularly in adolescents. In addition it may have direct~     implications on the development of insulin resistance and long-term complications.~      The Investigators hypothesis is that low circulating IGF-I and compensatory hyper-secretion~     of GH, in the presence of peripheral insulin excess, results in increased local IGF-I~     expression explaining both the deterioration in metabolic control and the increased risk for~     microvascular complications. Correction of imbalance in circulating and tissue-specific~     levels of IGF-I could lead to both better early metabolic control and to prevention of early~     diabetic complications in type 1 diabetic (T1DM) patients.~      Aim of the present study is to validate the microdialysis technique as a useable tool to~     predict local biological effects of IGF-1 and to understand the pharmacokinetics of local~     IGF-I actions after sc injection of Increlex in type 1 diabetic patients.~   "
151146|NCT01588080|"~     When babies are born premature, they often need help with their breathing. The equipment used~     to help them breathe is not very comfortable and they sometimes need to be put on a~     specialized breathing machine with a tube into their lungs. The breathing machine or~     ventilator can be damaging to the newborn's lungs and more damage can occur the longer the~     newborn stays on a ventilator leading to chronic lung disease later in their lives. A new~     device called neurally adjusted ventilatory assist or NAVA is available that the~     investigators believe may be more comfortable for the premature newborn and may help the baby~     come off breathing support sooner. When using this device, babies may not need to be put on a~     ventilator and can avoid the lung damage associated with the breathing tube and the~     ventilator. The objective of this pilot study is to compare this new breathing device called~     NAVA, to the equipment that is currently being used, called SiPAP, to support premature~     newborn's breathing after birth without a breathing tube. The investigators hope to show that~     with this new technology, premature newborns that are having a difficult time breathing, will~     come off breathing support sooner compared to the breathing machines that are currently being~     used. The hypothesis for this proposed study is that improved synchrony with noninvasive NAVA~     will decrease time spent on noninvasive ventilation and avoid intubation.~   "
151147|NCT01588067|"~     This study is designed to develop a clinical registry of Peripheral Arterial Disease (PAD)~     patients undergoing lower extremity revascularization to describe the population and assess~     comparative effectiveness of endovascular therapy versus surgery. In addition, this study~     will conduct a prospective cohort study of patients treated medically or undergoing lower~     extremity revascularization at the VA and Kaiser Colorado to compare changes in health~     status.~   "
151148|NCT01588054|"~     The purpose of this study is to define clinical and demographic features within the~     population suffering from cervical deformity to assist health professionals to make important~     treatment decisions.~   "
151149|NCT01588041|"~     The purpose of this study is to investigate the use of optical coherence tomography imaging~     integrated with an operating microscope (MIOCT) in ophthalmic surgeries.~   "
151150|NCT01588015|"~     This randomized phase I trial studies the side effects of vaccine therapy in preventing~     cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor~     stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body~     build an effective immune response and prevent or delay the recurrence of CMV infection in~     patients undergoing donor stem cell transplant for hematological malignancies.~   "
151154|NCT01587963|"~     The purpose of this study is to determine the effectiveness of high doses of Vitamin C in~     critically ill patients.~   "
151156|NCT01587937|"~     Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic~     resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in~     hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has~     published guidelines stating that all hospitals should develop an institutional program to~     enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic~     stewardship audit-and-feedback intervention for all patients reaching their third or tenth~     day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic~     use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The~     investigators hypothesize that this intervention will result in similar benefits outside of~     the intensive care unit, and so expanded the intervention to non-ICU medical and surgical~     wards. To increase the rigor of our program evaluation, the roll-out was conducted in a~     stepped-wedge randomized controlled design.~   "
151157|NCT01587924|"~     This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center~     study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from stable~     rhEPO to GSK1278863 in approximately 68 hemodialysis-dependent subjects with anemia~     associated with chronic kidney disease. The study consists of a screening phase of 2 weeks, a~     4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study~     eligibility is 9.5-12.0 g/dL and the subjects must have received the same rhEPO product with~     total weekly doses that varied by no more than 50% during the 4 weeks prior to the Screening~     visit (Week -1. This study aims to estimate the relationship between dose of GSK1278863 and~     Hgb response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic~     kidney disease after switching from a stable maintenance dose of recombinant human~     erythropoetin (rhEPO).~   "
151158|NCT01587911|"~     Assessing 5 different milk derived proteins versus placebo for appetite regulation and~     satiety, delivered via shake vehicle.~   "
151159|NCT01587898|"~     This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group,~     multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in~     approximately 68 subjects with anemia associated with chronic kidney disease who are not~     taking rhEPO and are not undergoing dialysis. The range of Hgb values for study eligibility~     is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once~     daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion.~   "
151160|NCT01587885|"~     This study will evaluate a single ingredient product (omeprazole 20 mg) with a combination~     product capsule (omeprazole 20 mg + sodium bicarbonate 1100 mg) in participants with frequent~     heartburn.~   "
151161|NCT01587872|"~     The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors~     can make the procedure difficult, and sometimes a complete examination is not possible.~     Complicating factors include poor bowel preparation and technical challenges such as~     differences in anatomy (long, redundant colonic segments), post-surgical adhesions,~     strictures and diverticulosis. A special endoscope with two inflatable balloons, originally~     designed to examine the small bowel, has been used for several years with success in such~     technically difficult colonoscopies. More recently a modified double-balloon instrument was~     designed specifically for colonoscopy, but the documentation of the performance of this~     instrument is limited. The aim of the present study is to investigate the performance of the~     double-balloon colonoscope in cases where conventional colonoscopy have failed due to~     technical difficulties.~   "
151162|NCT01587859|"~     Background:~      The existence, diagnosis and treatment of short esophagus is one of the controversies of the~     past which has recently re-emerged. The missed diagnosis of short esophagus and the~     consequent inadequacy of treatment is one of the major causes of failure of antireflux~     surgery.~      The daily clinical practice of surgeons dedicated to therapy of esophageal diseases could~     take advantage of the definition of frequency, preoperative predictors, intraoperative~     management and post operative outcomes of cases of foreshortened esophagus, in order to offer~     the patient affected by GERD the elements necessary for a conscious choice of therapy and to~     plan the best performance of the surgical procedure.~      Aims of the Study To define the percentage of cases among the total of antireflux procedures~     performed for type II-IV hiatus hernia, in which, after standard isolation of the ge junction~     and dissection of the mediastinal esophagus at least two centimetres of esophagus can not be~     replaced without any applied tension below the apex of the diaphragmatic hiatus.~   "
151163|NCT01587846|"~     Beneficial therapeutic effect of probiotics has been reported in children with irritable~     bowel syndrome, but not consistently in other functional gastrointestinal disorders. Although~     there is evidence that probiotics increase stool frequency and decrease stool consistency in~     healthy individuals the evidence for efficacy in constipation is limited.~      Children with functional abdominal pain (FAP) and constipation will be included in the study.~     Children with FAP will be randomized in one of two groups and will receive either L. reuteri~     in a daily dose of 108 CFU, or placebo during three months. Children with chronic~     constipation will receive either L. reuteri in a daily dose of 108 CFU and lactulose, or~     placebo and lactulose. Frequency and intensity of episodes of abdominal pain during and after~     intervention will be recorded in children with FAP. Frequency of defecation, stool~     consistency and need for lactulose will be recorded in children with chronic constipation.~   "
151164|NCT01587833|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and~     disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on five key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation.~      Benzodiazepines (BZDs) are one of the therapeutic groups most widely used, mainly indicated~     as hypnotics and anxiolytics. Guidelines recommend treatment courses not exceeding 4-6 weeks.~     However, long-term treatment is highly prevalent, particularly in older people with a~     prevalence ranging from 15 to 30%. However, treatment is often taken as needed.~      Hip/femur fractures are a major cause of morbidity and mortality, impair quality of life and~     impose a considerable economic burden. Among people aged 50 years and older, a case-fatality~     rate of 20% is associated within the first year.~      The relationship between benzodiazepines and hip fractures remains controversial.~     Psychotropic medication has been traditionally associated with hip fractures. Among~     psychotropic medication, long elimination half-life benzodiazepines were found to increase~     the risk of hip fractures in a case-control study published in the late eighties. Since then,~     several investigations have been performed, mostly in older patients focusing on the~     relationship between benzodiazepines and hip fractures, and between benzodiazepines and falls~     as a mechanism underlying this effect. A review performed in 2003, which included 11~     epidemiological studies, reported that results were not always consistent. Seven out of eight~     cohort and population based case-control studies, found an association, but different results~     were reported according to benzodiazepines' half-life. In four hospital-based case-control~     studies no association between benzodiazepines use and hip fracture has been described. Data~     on dosing was only included in three of the studies, and once more results were not~     conclusive. Results ranged from no effect to an increased risk with high dose regimens.~     Results from subsequent succeeding studies have also shown contradictions, with no~     association reported in one of the studies, and an association described for the short-term~     use of short half-life, high-potency benzodiazepines.~      Even though there is epidemiological evidence suggesting that the use of benzodiazepines~     increases the risk of hip fractures, problems rise with the definition of benzodiazepine~     exposure, or biases such as confounding by indication and the control for confounders. These~     remain unresolved topics that should be addressed in future studies. In the present protocol,~     it is proposed to further asses the risk of hip/femur fractures associated with~     benzodiazepines using different study designs in different primary databases, and to compare~     the results in order to evaluate the impact of design and population differences on the~     outcome of the study association.~      The objective of this study is to assess the association between benzodiazepines use and~     hip/femur fracture with different study designs (descriptive, cohort, nested case-control,~     case crossover and self control case series) across different primary care databases~     (Bavarian, Mondriaan, National Databases (Denmark), General Practice Research Database~     (GPRD), Base de Datos para la Investigación Farmacoepidemiologica en Atencion Primaria~     (BIFAP) and The Health Improvement Network (THIN)) and to compare the results between~     databases, across designs to evaluate the impact of design/database/population differences on~     the outcome of the studied association.~   "
151165|NCT01587820|"~     This is a randomized, open-label investigator initiated pilot/ feasibility study comparing~     the effectiveness of intra-arterial administration of cisplatin therapy to intravenous~     administration of cisplatin when each is combined with the radiation therapy found in~     standard care. Participants will be randomized to either intra-arterial or intravenous~     cisplatin chemotherapy. This study is designed to determine whether a large scale study is~     practical in the investigators clinical setting. Approximately 10 subjects will be enrolled~     over a 2 year period.~   "
151166|NCT01587807|"~     GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The~     purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     inhaled GSK1995057 in healthy subjects. The study will be in two parts. Part 1 is a~     single-dose escalating design of 5 sequential cohorts of healthy subjects. Part 2 is a~     single-dose, parallel group design comprising 2 groups of healthy subjects assessing the~     effect of GSK1995057 on lung inflammation following inhaled LPS challenge. Actual dose~     administered in Part 2 will be determined from emerging safety and PK data from Part 1 and~     Study TFR110951.~   "
151167|NCT01587794|"~     Experimental retinal detachment and reattachment models have demonstrated the recovery~     process of successfully reattached retina. However, optical coherence tomography analysis of~     each retinal layers following retinal reattachment has not been investigated This study~     investigated changes in thickness profiles of retinal layers after resolution of recent-onset~     rhegmatogenous retinal detachment (RRD) using optical coherence tomography images.~   "
151168|NCT01587781|"~     This study is about a drug called enoxaparin which is used to prevent or treat blood clots.~     There are no studies about the use of this drug in obese adolescents and yet the~     investigators use it to prevent clots when they have surgery at Children's National for~     weight loss. The investigators hypothesis is that the obesity leads to increased kidney size~     and faster drug clearance. Therefore the investigators think they might be underdosing these~     adolescents. This study will check the drug levels at different points after the drug dose to~     see whether the investigators are achieving the expected levels for prevention of clots.~   "
151169|NCT01587768|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 (WP2) and Workgroup 1. The primary aim of these studies is to develop, test and~     disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on 5 key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation. The standards to develop will contribute to~     decreasing the discrepancies in results from different studies in the future and increase the~     usefulness and reliability of these studies for benefit-risk assessment in the EU.~      We propose to assess the association between antibiotics use and idiopathic acute liver~     injury with different study designs (descriptive, cohort, nested case-control and case~     crossover) across different primary care databases and to compare the results between~     databases, across designs to evaluate the impact of design/database/population differences on~     the outcome of the studied association.~      Specific aims (in each database):~        1. To describe characteristics, clinical features, and risk factors for acute liver injury~          in patients exposed and unexposed to antibiotics.~        2. To estimate the overall risk of acute liver injury associated with antibiotics exposure~          (users and non-users) in each database~        3. To estimate the risk of acute liver injury associated with various antibiotics classes~        4. To estimate the risk of acute liver injury associated with specific individual~          antibiotics~        5. To assess the effect of dose and duration of use for specific individual antibiotics.~        6. To compare the results of a case-control study with the results of a retrospective~          cohort study and self-controlled case series study in the different databases~      The proposed studies will be collected in populations from the following databases: The~     General Practice Research Database [GPRD] (UK), Health Improvement Network [THIN] (UK), BIFAP~     [Base de datos Informatizada para estudios Farmacoepidemiologicos en Atencion Primaria]~     (Spain)- the Bavarian Claims Database (Germany), Mondriaan (Netherlands), and the National~     Databases of Denmark.~   "
151170|NCT01587755|"~     A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together~     with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.~   "
151171|NCT01587742|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 (WP2) and Workgroup 1. The primary aim of these studies is to develop, test and~     disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on 5 key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation. The standards to develop will contribute to~     decreasing the discrepancies in results from different studies in the future and increase the~     usefulness and reliability of these studies for benefit-risk assessment in the EU.~      Within WP2, five possible adverse event - drug pairs have been selected for analyses; one of~     these includes the possible role of calcium channel blockers (CCBs) in the risk of cancer.~     Analyses will address the hypothesis that CCBs modify the risk of cancer (all forms of cancer~     combined and various groups of cancers).~      This hypothesis will be investigated using two sources of data: the UK General Practice~     Research Database (GPRD) and the Danish national databases. Investigations in the UK may also~     use The Health Improvement Network (THIN).~      The primary objective of the study is to investigate the possible association between use of~     CCBs and risk of all forms of cancer combined, among adult patients (18 to 79 years of age~     during the study period, January 1, 1996 to December 31, 2009). The study will be conducted~     using three databases with different study designs (descriptive, cohort, population based~     cohort study and nested case-control) across different databases (GPRD, THIN, Danish~     databases) and to compare the results between databases, across designs to evaluate the~     impact of design/database/population differences on the outcome of the studied association.~      Secondary objectives are to investigate the potential association between use of CCBs and~     risk of all forms of breast cancer in women; all forms of prostate cancer; and all forms of~     colon cancer using the same age groups and databases).~   "
151172|NCT01587729|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and~     disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on five key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation.~      Fracture of the proximal end of the femur or hip is associated with considerable morbidity~     and mortality. Hip/femur fractures impair quality of life and impose a considerable economic~     burden, and occur with 20% mortality rate within the first year. Antidepressants (AD), mainly~     tricyclic AD (TCAs) and selective serotonin re-uptake inhibitors (SSRIs) have been associated~     with fractures in several studies. A review of 13 observational studies showed risk ratios~     ranging from 1.2 to 3.7 for current TCA users and a wide range of 1.5 to 8.6 for SSRI users.~     The majority of the studies in the aforementioned review reported increased risks of~     fractures in general with SSRIs use and more mixed risk outcomes for TCA use. Several~     mechanisms underlying this adverse effect have been postulated in the literature: e.g.~     through decrease in bone mineral density (BMD) or through blocking the serotonin transporter~     activity (5-hydroxytryptamine re-uptake) and hence affecting bone metabolism and structure or~     simply by falling or through co-morbidities such as depression itself. Previous observational~     studies differ in design, conduct and analysis of the considered association with varying~     degree of accounting for confounders. Confounding factors such as depression and other~     co-morbidities, previous fractures, concomitant drug use and lifestyle factors such as~     smoking have usually not been accounted for in most of the studies. In addition, small sample~     size, different methods used to ascertain exposure, selection bias and lack of data on~     compliance as well as important covariates limit the use of these results in benefit-risk~     analyses. Furthermore, studies evaluating different types of SSRI and TCA are few and~     dose-response relationship for most of the AD remains to be studied. We will study effects of~     cumulative exposure focusing on acute (less than 6 months) and long term exposure (at least 5~     years) and doses of exposure.~      The objective of the study is to assess the association between AD use and hip/femur fracture~     using different study designs (descriptive, cohort, nested case-control and case crossover)~     across different databases and to compare the results between and across databases and~     designs. This is to evaluate the impact of design/database /population difference in the~     outcome of the studies association.~      Data will be collected from the following databases: The Health Improvement Network [(THIN]),~     a UK-based primary care electronic medical record database, the Dutch Mondriaan project (a~     primarily general physician based database with some linkage to survey data from the~     Netherlands), Base de Datos para la Investigación Farmacoepidemiológica en Atencion Primaria~     [(BIFAP] (Spanish primary care database)), and the Bavarian statutory health insurance~     physicians' association database (German health insurance database from primary and secondary~     care).~   "
151173|NCT01587716|"~     This is a study of the sodium channel inhibitor, GSK2339345. Cohort 1 will assess the safety,~     tolerability and PK of single ascending doses of GSK2339345 administered via an aqueous~     droplet inhaler in healthy subjects. Cohort 2 will assess the safety, tolerability, and PK of~     repeat doses of GSK2339345 administered four times a day for two consecutive days via an~     aqueous droplet inhaler.~   "
151174|NCT01587703|"~     This study is divided into two parts; Part 1 of the study is a dose escalation phase to~     select the recommended dose for Part 2 based on the safety, pharmacokinetic, and~     pharmacodynamic profiles observed after oral administration of GSK525762 in the following~     subjects: NMC, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal~     cancer (CRC), neuroblastoma (NB), castration resistant prostate cancer (CRPC), triple~     negative breast cancer (TNBC), estrogen receptor positive (ER positive) breast cancer, and~     MYCN driven solid tumor subjects. Part 2 of the study will explore the safety, tolerability,~     pharmacokinetics, pharmacodynamics, and clinical activity of the recommended dose from Part 1~     in cohorts comprised of NMC, small cell lung cancer (SCLC), castration resistant prostate~     cancer (CRPC), triple negative breast cancer (TNBC), and estrogen receptor positive (ER~     positive) breast cancer subjects. Approximately 60 subjects will be enrolled in the Part 1~     and approximately 150 subjects will be enrolled in Part 2. A sub-study will be opened in Part~     1 to approximately 10-12 subjects in the United States to investigate the relative~     bioavailability of the besylate tablet compared to the amorphous free-base tablet at the~     maximum tolerated dose (MTD) or recommended phase 2 dosing (RP2D), the effect of high-fat~     high-calorie meal on the bioavailability of the besylate tablet at the MTD or RP2D and the~     dose proportionality of two doses of GSK525762 administered as besylate tablet.~   "
151175|NCT01587690|"~     MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in~     many human diseases. The purpose of this pilot study is to determine if microRNA expression~     is changed in untreated and interferon-beta-treated patients with multiple sclerosis.~   "
151213|NCT01587196|"~     The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers~     predicting drug use during and after treatment in 72 subjects addicted to prescription~     opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active~     medication. The brain fMRI measures will be correlated with the primary clinical outcome of~     drug use (by urine drug screen) during the treatment and follow-up phase.~   "
152643|NCT01568372|"~     The purpose of this study is to determine if a nurse telephone follow-up to parents of~     children who underwent a removal of their tonsils would be effective in reducing pain~     intensity, complications and resort to other healthcare services~   "
151176|NCT01587677|"~     Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide.~     Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis~     require advanced and expensive diagnostic methods that restrict their availability in~     resource limited countries where the burden of tuberculosis is highest. The development of~     rapid point of care diagnostics is required.~      Lipoarabinomannan (LAM) is part of the bacterial cell wall in M. tuberculosis. It is released~     when bacteria are multiplying or dying. LAM can be detected in the urine since it is filtered~     from the blood in the kidneys. The detection of LAM in the urine by conventional enzyme~     linked immuno-sorbent assay (ELISA) techniques was hampered in the past by a low sensitivity~     and multiple processing steps. Recently, fluorescence linked immuno-sorbent assay (FLISA) has~     been shown to detect LAM in concentrations that are several magnitudes lower that with ELISA~     based methods. Furthermore the procedure requires less separate steps for processing the~     sample.~      This study aims to validate the new diagnostic test by comparing patients with (a) confirmed~     tuberculosis (n=25), (b) infection with non-tuberculous mycobacteria (n=25), (c) bronchial~     carcinoma (n=25), (d) suspected tuberculosis but confirmed alternative diagnosis (estimated~     n=20). Single blood and urine samples of these groups will be used to evaluate the~     sensitivity and specificity of the test.~      In patients with confirmed tuberculosis the LAM FLISA will also be assessed as a biomarker~     for the monitoring of tuberculosis treatment success. Initially, 2-5 samples blood and urine~     are required during the first week, followed by twice weekly and weekly sampling intervals~     over a period of 12 weeks maximum. The study participation ends when the patient is~     discharged from hospital.~      As a substudy, the blood samples will be used to evaluate an enzyme linked immuno-sorbent~     assay (ELISA) for the detection of lipid antigens that are specific for Mycobacterium~     tuberculosis.~   "
151177|NCT01587664|"~     The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez~     intra-laryngeal implant in patients with dysfunctional larynx.~   "
151178|NCT01587651|"~     This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized,~     3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study~     will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with~     ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have~     previously received ticagrelor loading does (LD) and maintenance dose (MD)..~   "
151179|NCT01587638|"~     This study used an observational, retrospective cohort design to compare the presence and~     timing of new-onset diabetes (NOD) between hypertensive patients initiating therapy with~     carvedilol immediate-release (IR) and carvedilol controlled-release (CR) vs the following~     cardioselective beta blockers (BBs): atenolol, metoprolol succinate, and metoprolol tartrate~     (referred to hereafter as 'other BB').~      The aim of the study was to investigate the likelihood of developing NOD among hypertensive~     patients initiating carvedilol therapy vs other BB therapy in a real world setting derived~     from data contained in a large United States (US) managed care database.~   "
151180|NCT01587625|"~     In a randomized control trial conducted in six study centers/labour wards in Sweden,~     consenting nulliparous women in active phase of labour and with a defined delayed labour~     progress will be randomized to receive a regimen of either high or low dose of oxytocin.~     Primary outcome is caesarean delivery rate. Secondary outcomes are: Apgar score, need of~     neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate,~     length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain,~     epidural analgesia and the women´s childbirth experience one month postpartum (assessed with~     Childbirth Experience Questionnaire). Study results will contribute to establish good~     evidence-based routines regarding oxytocin treatment of delayed labour progress.~   "
151181|NCT01587612|"~     Hyperpronation is af frequent cause of excessive load in foot and crus. Pain and limited~     functional ability cause problems with work-related activities, sport activities and leisure~     activities.~      There are only few studies of the frequency of pain related to hyperpronation in foot and the~     effect of exercises. Medics and physiotherapists need sufficient evidence-based knowledge to~     treat these patients correctly.~      Therefore, the investigators want to study the effect of exercises and inner soles for~     treatment of patients with chronic pain and hyperpronation of foot.~   "
151182|NCT01587599|"~     Design and Procedure:~      The design is a randomised controlled multi-centre pilot study. 18 community pharmacies~     located in Mecklenburg-Western Pomerania, Germany, were randomised to either a control or an~     intervention group. These pharmacies recruited eligible patients out of their clientele and~     invited them to take part in the study. Participants were visited at home by the pharmacist~     and home-based medication reviews were conducted. The survey form has been developed by the~     research team and comprised amongst others items to adherence, adverse effects, drug intake,~     storage and quality of life. Thereafter all data were analysed by the pharmacist with a newly~     developed document called analysis guide aiming at the detection of drug related problems.~     Pharmacists of the intervention group discussed the results with the family doctor of the~     patients and the patients and tried to solve the drug related problems. This procedure was~     not undertaken in the control group.~      Six months later a second medication review was carried out in both groups.~      Study hypothesis:~      Pharmaceutical care reduces the overall number of drug-related problems of elderly patients~     with diabetes and impairments in mobility.~      Aim:~      The purpose of this study is to show that pharmaceutical care reduces the overall number of~     drug-related problems of elderly diabetes-patients with impairments in mobility and leads to~     both an improved health status and an improved quality of life.~   "
151183|NCT01587586|"~     Primary objectives:~      The purpose of this study is to determine and compare the sustained virologic response (SVR,~     undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups.~      To determine and compare the safety and tolerability of P1101 + Ribavirin across treatment~     groups.~   "
151184|NCT01587573|"~     The purpose of this study is to verify the discriminatory value of previously identified~     salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use~     population of patients with oral lesions suspicious for cancer.~   "
151185|NCT01587560|"~     The purpose of the study is to investigate fixation to bone and the clinical results~     following shoulder resurfacing arthroplasty. The study will compare results between an~     implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.~   "
151186|NCT01587547|"~     The purpose of this study is to develop an algorithm for embryo selection based on amino acid~     profiling (AAP) of spent culture medium. Development of the algorithm will be based on the~     ongoing implantation rate of the individual embryos transferred. As evaluated by ultrasound~     scan in gestational week 7.~   "
151187|NCT01587534|"~     The investigators planned a prospective, randomized, placebo controlled trial to test the~     hypothesis that weight loss in patients with unresectable pancreatic cancer with occlusion of~     the pancreatic duct can be reduced or prevented by pancreatic enzyme replacement therapy in~     combination with dietary counseling.~   "
151188|NCT01587521|"~     Patients with schizophrenia are more likely to have metabolic syndrome compared to general~     population. The criterion for metabolic syndrome in Asian people including: elevated waist~     circumference (male ≥ 90cm, female ≥ 80cm), elevated triglycerides ≥ 150mg/dL, reduced HDL~     cholesterol: male < 40mg/dL, female < 50mg/dL, elevated blood pressure: ≥ 130/85 mmHg,~     elevated fasting glucose: ≥ 100mg/dL. Several factors have been found to be associated with~     metabolic syndrome in schizophrenia, e.g. age, antipsychotic drugs, smoking, family history~     of metabolic disorder, stress, and quality of life.~      However, little is known about the prevalence of and factors associated in Asian. This study~     aimed to:~        1. Identify the prevalence of metabolic syndrome in patients with schizophrenia.~        2. Identify the factors associated with metabolic syndrome in patients with schizophrenia.~   "
151189|NCT01587508|"~     The purpose of this study is to assess the efficacy end tolerability of a new drug containing~     the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the~     treatment of acute lumbago.~   "
151190|NCT01587495|"~     The investigators are doing this study to learn more about the dosing and safety of ertapenem~     in women with suspected serious infections less than 42 days from the delivery of their~     infant.~   "
151191|NCT01587482|"~     Nowadays, stenting is became a standard of care in revascularization for superficial femoral~     artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains~     in-stent restenosis (ISR). While most of local therapies have failed to demonstrate~     significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous~     transluminal angioplasty remains the current standard of care for this indication. Recent~     studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo~     lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to~     evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA~     atherosclerotic lesions.~   "
151192|NCT01587469|"~     This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a~     longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for~     pulmonary TB. The sensitivity and specificity of the Xpert MTB/RIF (Mycobacterium~     tuberculosis/rifampin) assay performed on the first sputum collected for Xpert testing will~     be compared to gold standard conventional culture methods on two sputum specimens, in~     HIV-infected and HIV-uninfected participants.~   "
151193|NCT01587456|"~     The investigators planned to study relationship between osteoporosis and arterial rigidity~     within fractured patients cohort.~   "
151194|NCT01587443|"~     End-stage renal disease (ESRD) presents a heavy burden on a patient's psychological and~     social life, as well as overall quality of life (QoL). Health-related quality of life (HRQoL)~     in dialysis patients measures the physical, social or emotional well-being that is affected~     by ESRD and/or its treatment, and has been increasingly used as an outcome measure in~     interventional studies. Additionally, associations between social support and QoL have been~     observed, indicating that improved social support could improve HRQoL, morbidity and~     mortality in ESRD patients. However, it is not clear if hemodialysis (HD) and peritoneal~     dialysis (PD) have different impacts on HRQoL. Furthermore, comparisons of HRQoL and social~     support between HD and PD patients in the multiethnic society of Singapore have not been~     evaluated. As such, the investigators propose to conduct this cross-sectional study in the~     investigators local multiethnic ESRD patient population to evaluate and compare~     patient-reported outcomes (HRQoL and social support), economic and clinical laboratory~     outcomes in HD and PD patients.~      All chronic HD and PD patients seen in NUH outpatient renal or PD clinic will be included in~     this cross-sectional, observational study. Information on patient demographics,~     medical/medication histories, dialysis vintage, clinical laboratory data and associated~     medical costs will be obtained from clinic notes, electronic medical records and hospital~     databases. Patient-reported outcomes will be determined from scores of the Kidney Disease~     Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social~     Support Scale, Multidimensional Scale of Perceived Social Support, Kessler Psychological~     Distress Scale and Health Services Utilization questionnaires (for indirect costs), and~     compared between HD and PD patients.~      Results from this study will provide important HRQoL information to assist renal physicians~     and patients to make treatment decisions. Furthermore, intervention programs could be~     developed to improve social support based on patients' needs. These could in turn improve~     patients' HRQoL, morbidity and mortality outcomes with minimal risks involved.~   "
151195|NCT01587430|"~     The goal: to evaluate the role of high dose ara-c plus idarubicin and mitoxantrone~     consolidation followed by maintenance in the setting of high total cumulative anthracyclines~     dose(720-660 mg/m2).~   "
151196|NCT01587417|"~     To investigate safety, tolerability, pharmacokinetics including dose proportionality, and~     pharmacodynamics of BI 187004 CL within a predefined dose range~   "
151197|NCT01587404|"~     Until recently, there was no way of telling how firmly the tip of the catheter was in contact~     with the heart and how this contact was orientated. The electrical signals measured through~     the catheters, known as electrograms, are used to guide the sites and duration of ablation,~     but the effect of catheter contact and orientation on these signals in human heart muscle~     that is fibrillating is not known. New catheters have now been developed which can measure~     the force of contact at their tip: using these, the investigators will examine how contact~     force affects the electrical behaviour of heart muscle tissue in atrial fibrillation. The~     effect the force of contact has on the electrogram recorded will also be investigated. In so~     doing we hope to gain a better understanding of the relationship between tissue contact and~     the electrograms we measure and in so doing improve the safety and effectiveness of ablation~     procedures.~      Hypothesis: Catheter contact force and orientation have a significant impact on the~     characteristics of bipolar electrograms in the fibrillating human atrium.~   "
151198|NCT01587391|"~     To investigate safety, tolerability, pharmacokinetics including dose proportionality, and~     pharmacodynamics of BI 163538 XX within a predefined dose range~   "
151199|NCT01587378|"~     The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late~     miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester~     of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting.~      The investigators hypothesis is that metformin compared to placebo treatment from the first~     trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and~     preterm birth (gestational week < 37) in PCOS women diagnosed according to Rotterdam 2003~     consensus criteria, with singleton pregnancy.~   "
151200|NCT01587365|"~     To obtain safety and tolerability information in healthy subjects is administered as a single~     dose~   "
151201|NCT01587352|"~     This phase II trial studies how well vorinostat works in treating patients with melanoma of~     the eye that has spread to other parts of the body. Vorinostat may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
151250|NCT01586715|"~     The purpose of this study is to evaluate the practicability of the autologous e-ASC~     (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant~     perianal fistulae.~   "
151202|NCT01587339|"~     There are a number of anti-epileptic drugs available for the treatment of partial onset~     seizures in patients with epilepsy. This study is a systematic review of the published~     literature on anti-epileptic drugs and is designed to compare the relative effectiveness and~     tolerability of a selection of them with retigabine. The drugs chosen for this comparison~     were lacosamide, pregabalin, tiagabine, zonisamide and eslicarbazepine. They were chosen~     because they belong to the newer generation of drugs for epilepsy (as does retigabine) and~     they have a similar license as well as having published data from studies that were conducted~     in similar patient populations with similar methods. GSK commissioned YHEC (York Health~     Economic Consortium) to carry out this review and analysis. YHEC identified relevant studies~     from international databases. These studies had compared one of the chosen anti-epileptic~     drugs with placebo. The results were pooled and combined in order to summarize the data for~     individual drugs as well to compare the results for different drugs with each other and with~     retigabine. Since none of the individual clinical studies compared one active drug with~     another, this systematic review is an indirect comparison of these drugs, using an~     established and recognised methodology which has well understood limitations.~   "
151203|NCT01587326|"~     The association of cytokines with escitalopram has not been investigated in patients with~     major depressive disorder (MDD). Hence, the investigators will examine this association.~   "
151204|NCT01587313|"~     This is a single center, open-label, two-period study. There will be nine healthy human~     volunteers arbitrarily assigned to one of four groups. The study objective is to compare the~     action of various combinations of BiDil extended-release capsules and commercial BiDil~     Tablets in the body over a period of time.~   "
151205|NCT01587300|"~     Medical scientists want to find better ways to treat neuroblastoma and to find ways to~     prevent the tumor from growing back. To do this, they need more information about the~     characteristics of neuroblastoma cells. Therefore, they want to study samples of~     neuroblastoma tissues and neuroblastoma and normal cells in the blood and bone marrow that~     may be related to the growth of neuroblastoma cells. Doctors and other medical scientists~     also want to find better ways to detect and measure neuroblastoma to improve the ability to~     follow the response of tumor cells to therapy.~   "
151206|NCT01587287|"~     To comprehensively assess the precision and agreement of anterior corneal power measurements~     using 8 different devices.~   "
151207|NCT01587274|"~     Low back pain causes 2.4% of visits to US emergency departments (ED) resulting in 2.7 million~     visits annually. In a general low back pain (LBP) population, prognosis is poor. About 50% of~     patients who visited general practitioners with new onset musculoskeletal LBP report~     persistent pain and functional disability three months after the index visit. Outcomes are~     similarly poor for the population of patients forced to use an ED for management of their~     LBP. In an observational study of patients with non-traumatic LBP recently completed at the~     PI's institution, patients were contacted one week after ED discharge: 70% reported~     persistent back-pain related functional impairment, 59% reported moderate or severe LBP, and~     69% reported analgesic use within the previous 24 hours. Three months after the ED visit, 48%~     reported functional impairment, 42% reported moderate or severe pain, and 46% reported~     analgesic use within the previous 24 hours.~      A variety of evidence-based medications are available to treat LBP. Non-steroidal~     anti-inflammatory drugs (NSAID) are more efficacious than placebo with regard to pain relief,~     global improvement, and requirement of analgesic medication. Skeletal muscle-relaxants too~     are effective for short-term pain relief and global efficacy. Opioids are commonly used for~     moderate or severe acute LBP,(9) though high-quality evidence supporting this practice is~     lacking.~      Treatment of LBP with multiple concurrent medications is common in the ED setting. Emergency~     physicians often prescribe NSAIDs, skeletal muscle relaxants, and opioids in combination.~     Several clinical trials have compared combination therapy with NSAIDS+ skeletal muscle~     relaxants to monotherapy with just one of these agents. These trials have reported~     heterogeneous results. The combination of opioids + NSAIDS has not been evaluated~     experimentally in patients with acute LBP.~      Given the poor pain and functional outcomes that persist beyond an ED visit for~     musculoskeletal LBP, the investigators propose a clinical trial to evaluate whether combining~     muscle relaxants or opioids with NSAIDs is more effective than NSAID monotherapy for the~     treatment of non-traumatic, non-radicular low back pain. Specifically, the investigators will~     evaluate three distinct hypotheses:~        1. The combination of naproxen + cyclobenzaprine will provide greater relief of LBP than~          naproxen alone seven days after an ED visit, as measured by the Roland Morris low back~          pain functional disability scale~        2. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of~          LBP than naproxen alone seven days after an ED visit, as measured by the Roland Morris~          low back pain functional disability scale~        3. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of~          LBP than naproxen + cyclobenzaprine seven days after an ED visit, as measured by the~          Roland Morris low back pain functional disability scale~   "
151208|NCT01587261|"~     Animal and human data have supported the notion that administration of large doses of Vitamin~     C has beneficial effects on those subjects suffering from large burns. This effect may be~     due, in part, to the antioxidant and free-radical-scavenging properties of Vitamin C. These~     studies have demonstrated an improvement in urine output during resuscitation and reduced~     need for fluid volumes during resuscitation. In turn, these subjects demonstrated a reduction~     of wound edema, improved respiratory status (demonstrated by improvements in P:F ratios and~     reduced ventilator days), and no differences in terms of the possible complications of~     high-dose vitamin C administration between standard and treatment groups. The purpose of this~     study is to prospectively determine if Vitamin C can be safely used as an adjunctive~     treatment for patients suffering severe thermal injuries. High-dose vitamin C administered at~     a dose of 66mg/kg/hr during the acute phase of severe burn injuries will reduce fluid~     requirements in the first 48 hours after injury.~   "
151209|NCT01587248|"~     To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL),~     operating time, drain Volume and drain Days, seroma formation, surgical site infection and~     postoperative pain in adult females undergoing MRM at a tertiary care hospital. We~     hypothesized that harmonic yields better outcome than electrocautery dissection.~   "
151210|NCT01587235|"~     This study will evaluate and compare the effectiveness of MK-0653 (Vytorin) to current~     standard treatment with other statins for the treatment of dyslipidemia in moderate,~     moderately-high and high-risk participants.~   "
151211|NCT01587222|"~     The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin~     during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and~     followed during 16 weeks. The effects on renal function will be evaluated 12 and 16 weeks~     after the beginning of the treatment by isotopic evidence and biochemist determinations. Also~     it will be evaluated arterial pressure and determination of vasoactive hormones (plasma~     renin, aldosterone and norepinephrine).~   "
151212|NCT01587209|"~     The investigators hypothesize that membrane microparticles (MPs) are liberated into the blood~     stream in response to decompression stress and that certain MPs characteristics initiate~     inflammatory responses that contribute to the clinical syndrome the investigators call~     decompression sickness. The research goal is to evaluate the number, type and time-course for~     elevations in MPs in sport SCUBA divers who present for treatment of decompression sickness.~     Blood samples are to be taken from consenting patients before and after they undergo~     treatment for decompression sickness and at a follow-up clinic visit from 1 to 3 weeks later~     (three samples total).~   "
151214|NCT01587183|"~     This study will test strategies to help people with prehypertension adopt a running program~     to reduce their blood pressure in the long term. This study will be a 12 week intervention of~     about 40 participants randomized to running educational material, group based running~     instruction, or group based running instruction focused on form and all given the option to~     use the supplemental mHealth intervention. The purpose of this study is to collect~     feasibility, acceptability and preliminary efficacy data in preparation for a larger planned~     NIH-R01 study.~   "
151215|NCT01587170|"~     After spinal cord injury, patients develop a spastic syndrome that is characterized by~     hyperactive reflexes, increased muscle tone, clonus and involuntary muscle spasms. The~     neuronal mechanisms behind the development of spasticity remain largely unknown, though~     animal experiments have shown that changes occur both at the level of the motoneuron and~     sensory neurons. This project aims to examine the changes that occur in the modulation of~     sensory afferent transmission after spinal cord injury, and how these changes can contribute~     to the triggering and initiation of muscle spasms after chronic spinal cord injury in humans.~      It is known that after spinal cord injury, the majority of descending sources of monoamines,~     such as serotonin (5HT), are abolished. Animal experiments have shown that 5HT receptors on~     sensory neurons in the spinal cord are responsible for inhibiting sensory transmission. As a~     result, after spinal cord injury these receptors are no longer activated below an injury,~     resulting in the production of large, long excitatory responses in the motoneuron when~     sensory are activated. This large sensory activation of the motoneuron can, in turn, activate~     a long response in the motoneuron to produce an involuntary muscle spasm. The aim of our~     study is to determine whether, similar to animal experiments, the 5HT1 receptors are~     responsible for sensory inhibition in spinal cord injured subjects, and whether activating~     these receptors (through the 5HT1 agonist Zolmitriptan) will restore the normal inhibition of~     sensory transmission that is lost after injury, thereby resulting in a decrease in the~     initiation of involuntary muscle spasms.~   "
151216|NCT01587157|"~     Capnography provides noninvasive monitoring of ventilation and can allow early recognition of~     altered respiration patterns and apnea. The aim of this prospective study was to compare the~     detection of apnea and the prediction of oxygen desaturation and hypoxemia by capnography~     versus clinical surveillance during procedural sedation for percutaneous transhepatic~     cholangiodrainage (PTCD).~   "
151217|NCT01587144|"~     The purpose of the study is to determine the effectiveness of an investigational drug called~     lucanthone, when combined with temozolomide (TMZ) and radiation in the treatment of~     Glioblastoma Multiforme (GBM).~   "
151218|NCT01587131|"~     The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will~     be safe and generally well tolerated in healthy elderly adult volunteers and will result in~     greater immunogenicity when used to prime the immune response to a dose of a trivalent~     inactivated seasonal vaccine.~   "
151219|NCT01587118|"~     This is an open-label pilot study of adjunctive asenapine for the treatment of Posttraumatic~     Stress Disorder (PTSD) in veterans who have not fully remitted to an adequate trial of~     standard antidepressant treatment.~   "
151220|NCT01587105|"~     Seattle Children's Hospital (SCH), in collaboration with several health plans and Washington~     State Department of Social and Health Services developed the Comprehensive Case Management~     (CCM) program with the goal to reduce costs of care for medically complex children cared for~     at SCH as well as improve their health status and the quality of care they receive. The CCM~     program aims to develop and facilitate a reliable and standardized process that empowers the~     child's primary care provider and provides him/her with the resources s/he needs to avoid~     unnecessary emergency department visits and admissions. Our study will include children who~     had a hospitalization or emergency department visit at Seattle Children's between 2009-2012~     and, at that time, had multiple active chronic medical issues but had no specialty service at~     Seattle Children's to help their primary care providers manage them.~   "
151221|NCT01587092|"~     This is a pilot study to assess the feasibility of using treadmill desks (Workstations)~     within a Louisiana office workplace and to determine the effects of walking while working in~     overweight or obese, sedentary individuals.~   "
151222|NCT01587079|"~     The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol~     Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate~     to severe COPD~   "
151223|NCT01587066|"~     Quetiapine is one of atypical antipsychotics with good efficacy and better side effect~     profiles than conventional antipsychotics, so it is being widely used beyond the treatment of~     schizophrenia. Recently, the BOLDER I and II study showed that quetiapine monotherapy is an~     effective and well-tolerated treatment for depressive episodes in bipolar disorder. However,~     most c1inicians did not have confidence with quetiapine monotherapy yet, and most practice~     guidelines recommend the monotherapy with mood stabilizer as the first-line treatment. The~     Korean medication algorithm for bipolar disorder published in 2006 also recommend the~     monotherapy with lithium, divalproex, or lamotrigine in the treatment of mild to moderate~     depressive episode of bipolar disorder.~      Therefore, the aim of this study is investigating the efficacy and safety of quetiapine~     monotherapy when compared with mood stabilizer monotherapy. In addition, the investigators~     are going to reveal the quality of sleep and quality of life, of the two groups of patients.~   "
151224|NCT01587053|"~     The purpose of this study is to measure the INR (International Normalized Ratio) time~     percentage in the target zone (TTR: time in therapeutic range) of children benefiting from~     the AVK therapeutic education program.~   "
151225|NCT01587040|"~     Primary Objective:~      The purpose of this study is to determine the long term safety and tolerability of SAR245408~     and SAR245409 as a monotherapy or as part of a combination regimen in subjects who are~     benefiting from treatment.~   "
151226|NCT01587027|"~     This safety study is the first in a series of studies testing the application of the~     combination of aminophylline and methazolamide.~   "
151251|NCT01586702|"~     Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial~     infarction. Poor adherence to evidence based secondary prevention regimens is frequently~     seen. Support programs for patients may not only improve adherence to recommended therapies~     but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize~     that compared to regular care, a structured and patient centered secondary prevention program~     will lead to a relative risk reduction of at least 28% of recurrent vascular events.~   "
151227|NCT01587014|"~     The purpose of this study is to test the safety and feasibility of the Prima-Temp Thermometer~     Patch in determining baseline temperatures of research subjects in a hospital intensive care~     unit (ICU).~      Primary Objective: Assess safety of the Prima-Temp temperature patch with nursing staff skin~     site assessments.~      Secondary Objective: Establish individual subject baseline temperature using intermittent~     temperature measurements (every 5 minutes) with the Prima-Temp thermometer patch and wireless~     transmission of the data to a receiver box and HIPAA compliant, centrally located personal~     computer (PC) and compare research subject's baseline temperature with temperatures taken in~     the ICU in the normal course of care.~   "
151228|NCT01587001|"~     This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC),~     on inflammation and oxidative stress in sarcoidosis.~   "
151229|NCT01586988|"~     The IMAGE intervention was developed to improve parenting and self-care skills in mothers~     infected with HIV. It is expected that an improvement in these areas will in turn improve the~     mother's physical and mental health as well as the child's mental health and behavioral~     adjustment.~   "
151230|NCT01586975|"~     The purpose of this study is to determine if PFA results correlate with ischemic event~     outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more~     efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.~   "
151231|NCT01586962|"~     This is an open label, in-use study to assess the warming sensation, acceptability and local~     tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in~     subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to~     evaluate the acceptability concerning a warming sensation effect and its potential benefit in~     the target population.~      The primary objective is to assess the warming sensation caused by the excipient IFF flavor~     316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup.~     The syrup contains (0.15% w/v) warming flavor.~      The Secondary Objectives are to assess subject acceptability of the syrup and the safety and~     tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from~     symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal~     congestion associated with colds and flu symptoms such as pain, headache and/or fever.~     Subjects must have one or more symptoms per category:~        1. mild to moderate body pain, headache, fever or sore throat~        2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing~          Adolescents will be included in the study population~   "
151232|NCT01586949|"~     The purpose of this study is to determine whether the intervention Daily Challenge (MeYou~     Health, LLC), a behavioral intervention delivered online, is effective in improving~     individuals' well-being.~   "
151233|NCT01586936|"~     This study is conducted in Japan. The aim of this registry study is to observe the use of~     single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term~     outcomes, including effectiveness, safety, quality of life and treatment satisfaction with~     the approved treatments.~   "
151234|NCT01586923|"~     The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage~     RBCs for the time required to clear elevated blood lactate levels in children with severe~     anemia.~   "
151235|NCT01586910|"~     The purpose of the study is to investigate the safety and efficacy of transcatheter aortic~     valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at~     intermediate surgical risk by randomizing patients to either Surgical Aortic Valve~     Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.~      Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of~     transcatheter aortic valve implementation (TAVI) in patients with sever symptomatic Aortic~     Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the~     pivotal clinical trial.~   "
151236|NCT01586897|"~     This project tests a model of chronic disease medication management in which the decision to~     initiate or adjust medical therapy is directly linked to a sequence of subsequent clinical~     actions (e.g. monitoring for adverse drug events, assessing response to therapy, changing~     medication dose) performed independently of the office visit. The investigators hypothesize~     that establishing a visit-independent, health information technology (IT) supported cycle of~     laboratory monitoring and iterative medication dose adjustment will result in more effective~     chronic disease care.~   "
151237|NCT01586884|"~     It is hypothesized that it is both safe and feasible to use an interventional approach to LV~     lead placement (placing the LV lead guided by acute hemodynamic measurements), and that the~     LV lead can be placed in a position that is superior to the initial empiric lateral wall LV~     lead location in less than 30 minutes without significant risk to patients. The time from RV~     capture to LV activation correlates with the optimal pacing site based on stroke volume &~     dP/dt measurements.~   "
151238|NCT01586871|"~     Mucopolysaccharidosis (MPS) syndromes are disorders characterized by enzyme deficiencies, and~     they have been linked to heart health complications. However, there are currently no proven~     markers of heart and artery health for this population. The main purpose of this~     observational study is to evaluate the ease and convenience of a non-invasive measurement of~     artery function in MPS I, MPS II and MPS VI patients compared to healthy control subjects. An~     observational study is a research design meaning that there is no treatment in this study.~      The research questions are:~        1. Is the artery health of MPS I, II and VI patients different than healthy controls?~        2. Is the artery health of MPS VI patients different than MPS I and II patients?~      It is hypothesized that MPS patients will have poorer outcomes of artery health compared to~     healthy controls.~   "
151239|NCT01586858|"~     Rituximab is the first drug approved by the United States Food and Drug Administration (FDA)~     for the treatment of patients with granulomatosis with polyangiitis (Wegener's~     granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the~     long-term safety and efficacy of this drug is not yet clear. This study proposes to follow~     patients who were enrolled in the RAVE study to determine if treatment with rituximab~     influences long-term outcomes.~   "
151240|NCT01586845|"~     The purpose of this study is to demonstrate the efficacy and safety of voclosporin~     administered orally twice daily for the prevention of acute allograft rejection in recipients~     of a kidney transplant.~   "
155881|NCT01525810|"~     The primary purpose of this study is to determine whether the hepatitis C virus continues to~     remain unable to be detected in subjects who were previously treated with BMS-914143 and~     achieved sustained virologic response~   "
151241|NCT01586832|"~     Stocking of essential supplies in an emergency department (ED) is crucial in order to~     efficiently and effectively take care of patients. When equipment and supplies are not~     available to patient care providers, an imbalance in the delivery of care is created. The~     amount of time nurses spend away from the bedside obtaining supplies has only been~     superficially studied; however, one study proposed that the majority of nurses spend 5 to 20~     percent or more of their time during a shift. This results in 30 minutes to two-and-a-half~     hours of a twelve hour shift being lost to retrieving supplies that are not available.~      Cabinets and drawers have recently been eliminated in the rooms and stock is kept in supply~     towers that contain all the necessary supplies to adequately take care of patients with the~     exception of medications, or stationary supplies. Towers are restocked every morning by a~     stocking technician by taking the towers to the stock room, resupplying them based on~     previously established PAR levels, and utilizing a standard chart that describes exactly what~     supply, and how many to stock within a specified area of the cart.~      During their shift, the stocking technician must also respond to pages concerning low stock~     levels.~      Hypothesis:~      Nurses spend a significant amount of time away from the patient bedside during their shift~     looking for supplies.~   "
151242|NCT01586819|"~     This study is being done to find out if the use of botulinum toxin prior to a medium strength~     combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will~     improve the appearance of crow's feet wrinkles when compared to a chemical peel alone.~     Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular~     nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and~     lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two~     products/procedures have been FDA approved to improve the appearance of facial wrinkles.~   "
151243|NCT01586806|"~     For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative~     period can be a painful experience without adequate pain management. Hence the investigators~     propose a randomized controlled clinical study, investigating prolonged saphenous nerve~     blocks. Patients will be randomized to receive saphenous nerve blocks with or without~     dexamethasone, a corticosteroid used to prolong analgesia.~      Depending on the randomized treatment assignment, patients may receive one of the following:~        1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);~        2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;~        3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.~      Patients will be followed postoperatively. Following admission to the recovery room, data~     collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data~     collectors will also record patient satisfaction, pain medication use and any side effects~     experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days~     1, 2 and 14 and asked questions about their general well-being.~   "
151244|NCT01586793|"~     The aim of this randomized, single-blind trial is to evaluate the effectiveness and~     tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation~     (rTMS) in patients with resistant bipolar depression. Patients will be assigned to receive~     either high or low frequency rTMS for 20 consecutive workdays (4 weeks). 10 Hz (high)~     frequency rTMS and 1 Hz (low) frequency rTMS will be given over the left or right~     dorsolateral prefrontal cortex (DLPFC), respectively. Patients will be assessed with several~     psychometric instruments at baseline, and at weeks 5 and 9.~   "
151245|NCT01586780|"~     The purpose of the study was to investigate the efficacy of intake of whey or soy protein~     isolates, respectively, with or without supplementation of amino acids, on post-meal insulin~     secretion and glycaemic regulation. Additionally, the effect on plasma amino acids, gut~     hormones and ghrelin in plasma, as well as subjective satiety was investigated.~   "
151246|NCT01586767|"~     The purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy~     (IMRT) or proton radiation therapy would result in improved local control rate and lowered~     toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result~     in equivalent or improved local control rate with similar or lower toxicity compared to IMRT,~     in the treatment of locally advanced sinonasal malignancy.~      Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in~     promising outcome in patients with sinonasal malignancy. To this date, no prospective study~     has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton~     radiation therapy. This Phase II trial is the first prospective study conducted to determine~     the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer.~      IMRT and proton radiation therapy are the two most established and most commonly employed~     advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly~     controversial whether one is superior to the other in terms of local control and toxicity~     outcome. It is also not clear if a subset of patients would benefit more from one treatment~     technology versus the other.~      Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam~     is only available at a few centers in the United States, it is not feasible at present to do~     a Phase III study randomizing patients between IMRT and proton radiation therapy. In this~     study, a planned secondary analysis will be performed, comparing the treatment and toxicity~     outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial~     will be used to design future multi-center prospective trials and to determine if randomized~     trial is necessary.~      In this study, the treatment technique employed for an individual case will not be determined~     by the treating physician(s), but rather by the most advanced technology available at the~     treating institution for the treatment of the sinonasal cancer. At the Massachusetts General~     Hospital (MGH), proton beam therapy will be used for patients who meet the eligibility~     criteria. For institutions where protons are not available or institutions where the proton~     planning systems have not been optimized, IMRT exclusively will be used for the treatment of~     sinonasal cancer. Patient and tumor characteristics are expected to be comparable between~     IMRT- and proton- institutions~   "
151247|NCT01586754|"~     Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction~     and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic~     and randomized clinical trials. Carotis intima-media thickness is also found to be elevated~     in early stages of atherosclerosis. Recent studies have shown correlations between~     homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but~     no data exists for obese or overweight patients who also have metabolic syndrome, in terms of~     markers of subclinical organ damage. Since obesity is a risk factor for cardiovascular~     disease and since it is known that patients with metabolic syndrome are at higher risk of~     cardiovascular events, the investigators wanted to examine whether there is an association~     between homocysteine, microalbumin levels and carotid intima-media thickness in patients with~     or without metabolic syndrome, who are either overweight or obese.~   "
151248|NCT01586741|"~     This is a three armed prospective randomized trial that will compare two different surgical~     techniques for reconstruction of the abdominal wall diastasis with a conservative treatment~     procedure.~      The study hypothesis:~      Which surgical approach provides the safest and best long term results for patients with~     abdominal wall diastasis either the insertion of net alternative with a double row suture or~     exercise alone?~   "
151249|NCT01586728|"~     This is an open, multicenter, prospective, randomised and cross over study, comparing in~     patients with cystic fibrosis aged > 6 years, 2 periods of 6 weeks of oxygen therapy or room~     air, separated by a wash out period of 2 to 6 weeks.~   "
151252|NCT01586689|"~     This study is examining the relative effects of alternative aftercare models for ex-offenders~     who are recovering from substance abuse/addiction. The study is a longitudinal, randomized~     field trial that assigns participants to one of three conditions: Oxford House, a~     professionally-run residential treatment facility, or a control condition that involves usual~     aftercare chosen by participants (which may include no treatment at all). Oxford Houses are~     self-run residential recovery homes based on the premise of mutual support. These homes do~     not involve professional treatment staff and the expenses (e.g. rent, utilities) are paid for~     by the residents. The hypothesis of this study is that Oxford House participants will have as~     good or better outcomes in terms of substance recovery, recidivism, and health in comparison~     to the participants who were assigned to the residential treatment facility, and better~     outcomes in comparison to the control group. In addition, the cost to government/tax payers~     will be substantially lower given that participants pay their own way.~   "
151253|NCT01586676|"~     The virtual requirement that substance abuse programs use evidence-based treatments (EBT) has~     prompted the development of dissemination strategies to promote EBT technology transfer.~     Implementation research, clinical trial training methods, and clinician training studies~     suggest that clinical supervision that involves direct observation, fidelity rating-based~     feedback, and coaching of therapeutic skills is a promising dissemination approach. However,~     clinical supervision delivered within substance abuse programs by on-site supervisors has~     never been directly tested in a randomized controlled trial to determine the impact of~     supervision on both clinician EBT skills and client treatment outcomes.~      Recent results from two NIDA CTN protocols testing the effectiveness of Motivational~     Interviewing (MI) have shown that community program clinicians can learn to deliver MI with~     fidelity when receiving MI supervision from their program supervisors after workshop training~     and that their implementation of MI early in treatment improves client retention and primary~     substance use outcomes. A MI supervision manual called MIA: STEP (Motivational Interviewing~     Assessment: Supervisory Tools for Enhancing Proficiency) was developed from these protocols~     and has begun to be widely distributed by NIDA in partnership with SAMHSA for community~     program use. The effectiveness of the MIA: STEP supervision approach is unknown.~      This study will directly test the effectiveness of MIA: STEP supervision on clinician MI~     fidelity and on client outcomes by randomly assigning 60 clinicians and 420 substance-using~     outpatients from 11 community programs within Connecticut to one of two conditions in which~     clinicians in both conditions will deliver a 1-session MI intervention to clients as the~     enter treatment. The conditions are: 1) workshop training plus MIA: STEP supervision, and 2)~     workshop training alone with supervision-as-usual practices used at each program. This~     project will be the first randomized trial to examine the impact of clinical supervision in~     an empirically based treatment on both clinician and client outcomes. Moreover, because it~     will provide workshop training and supervision completely within the context of community~     programs and utilize in-house program supervisors, it will provide a rigorous evaluation of a~     feasible model for disseminating EBTs such as MI.~   "
151254|NCT01586663|"~     This is a randomized controlled trial with blinded evaluator and follow-up of one year.~     Seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.The~     patients can not change their medication during the study. Patients will be evaluated at~     baseline and at 3, 6, 9 and 12 months. The experimental group will use a serial night time~     position splint who will be adjusted monthly, while the control group will remain the drug~     treatment. The outcomes assessed will be: pain, hand range of motion, quality of life,~     functional capacity, upper limb function and dexterity. Our hypothesis is that the serial~     night time position splint will improve the hand range of motion in diffuse systemic~     sclerosis patients.~   "
151255|NCT01586650|"~     This is a randomized controlled trial with blinded assessor on the effects of aerobic~     exercise (walking)in patients with Ankylosing Spondylitis.~   "
151256|NCT01586637|"~     Effectiveness of an art therapy program for the treatment of pain and improvements in both~     quality of life and body image of patients with fibromyalgia.~   "
151257|NCT01586624|"~     The purpose of this study is to determine whether using two drugs together called vandetanib~     and selumetinib is effective in the treatment of cancer. The first part of this study will~     include patients with any solid tumour and the second part of this study will include only~     patients with non small cell lung cancer. The four main aims of this clinical study are to~     find out:~        -  If the two drugs can be given safely to patients when given together.~        -  The maximum dose that can be given safely to patients.~        -  More about the potential side effects of the drugs and how they can be managed.~        -  What happens to vandetanib and selumetinib inside the body.~   "
151258|NCT01586611|"~     Chemotherapy is often used to help shrink the cancer temporarily and may improve survival for~     patients with incurable pancreas cancer that has spread to other organs. In Canada, the~     gemcitabine chemotherapy is used to treat pancreas cancer that has spread. The combination of~     oxaliplatin with other chemotherapies, including 5-fluorouracil, leucovorin, and irinotecan~     has also been studied and has benefit for patients with advanced pancreas cancer. To date,~     there is no test that can be done on a patient's tumour to tell if chemotherapy will work in~     pancreatic cancer. Human equilibrative nucleoside transporter 1 (hENT1) has been shown to be~     a possible predictor that gemcitabine may or may not work but this needs to be proven in a~     randomized study where patients get treated with gemcitabine or a different kind of~     chemotherapy while their tumours get tested for hENT1.~      This study is being done because we want to prove that hENT1 can predict if gemcitabine will~     work in advanced pancreas cancer and if it can, we also would like to show that a different~     chemotherapy combination called FOLFOX (a combination of 5-fluorouracil, leucovorin, and~     oxaliplatin) will be helpful for patients whose tumours don't have hENT1.~   "
151259|NCT01586598|"~     The purpose of this study is to determine whether sensory retraining exercise could improve~     lip numbness caused by bilateral sagittal split of mandible.~   "
151260|NCT01586585|"~     The investigators will monitor cardiac patients rehabilitation post op upon their pre op~     status.~   "
151261|NCT01586572|"~     Globally, polio cases have decreased by over 99% since 1988. However, wild poliovirus cases~     continue in Pakistan. Conflict and lack of access to children due to on-going insecurity in~     tribal areas present special challenges in interrupting transmission rapidly. There exists~     limited knowledge on the effect of shorter intervals of mOPV vaccination on immunogenicity~     levels in young children. The aim of this study is to demonstrate the non-inferiority of~     shorter intervals (7 and 14 days) between doses of mOPV1 vaccine compared to the customary~     interval (30 days). A 4th arm will receive bivalent (bOPV) vaccine at standard intervals~     beginning at 6 weeks of age.~   "
151262|NCT01586559|"~     A comparative prospective study assessing the outcomes of recti muscle diastasis correction~     with absorbable suture.~   "
151286|NCT01586247|"~     Healthy older volunteers will be recruited to a study where they will be given four different~     treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a~     synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be~     collected and analysed for changes in faecal microbial populations and selected immune~     responses.~   "
175264|NCT01271036|"~     This is a one week study designed to test the safety of a personal lubricant during in-home~     use for subjects who perceive themselves as having sensitive skin.~   "
151263|NCT01586546|"~     Aim: To answer the questions of whether a Mind-Body Medicine (MBM) skills group facilitated~     face-to-face and online can improve measures of Quality of Life (QOL) in a population of~     cancer patients.~      Value of Study: Technological advances have contributed to new venues for healthcare~     delivery. It is imperative that these new delivery methods, for individual and/or group~     psychosocial services are sufficiently tested and validated. Research shows that there is~     very little knowledge about differences in communication styles between online and~     face-to-face groups, nor is there much knowledge on the overall efficacy of online groups.~      Phenomenon Studied: Can MBM skills groups improve the quality of life of cancer patients? Is~     there a difference in outcome between a MBM skills group delivered face-to-face and a MBM~     skills group delivered online.~      Reasons Leading to Proposing the Project: Despite encouraging research showing that~     psychosocial interventions have positive effects in the lives of cancer patients, more~     research is needed due to several problems of current research, such as poor study design,~     lack of use of technological advances and relatively few existing studies on the~     effectiveness of MBM therapies in the oncological setting.~      Stated Hypothesis:~      Hypothesis 1:~      There is no difference between baseline QOL measures and QOL measures at the end of~     face-to-face facilitated MBM skills groups.~      Hypothesis 2:~      There is no difference between baseline QOL measures and QOL measures at the end of Online~     facilitated MBM skills groups.~      Hypothesis 3:~      Participation in either, online facilitated MBM skills groups or face-to-face facilitated MBM~     skills groups will improve QOL measures when compared to control group.~      Hypothesis 4:~      Patients in the control group (waitlist control, care as usual group) will have no~     improvement on QOL measures.~      Anticipated Value to the Larger Community: According to the National Center for Complementary~     and Alternative Medicine (NCCAM) …there is a need for reliable, objective, evidence-based~     information regarding the usefulness and safety—or lack thereof—of CAM (National Center for~     Complementary and Alternative Medicine, 2011, p.3). This study will add to general scientific~     knowledge of CAM and MBM.~   "
151264|NCT01586533|"~     This double-blind, randomized, comparator-controlled Phase II study is designed to establish~     the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with~     left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease~     activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects~     will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or~     comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally~     into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the~     trial will be enrolled concurrently in a randomized fashion.~   "
151265|NCT01586520|"~     Thyroid cancer is a relatively rare disease but its incidence is increasing in many~     countries.. Early and accurate diagnosis leading to earlier treatment and intervention is~     recognised as a major factor in determining a good outcomes. This study will investigate new~     ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers. The~     study will take samples from patients with differentiated thyroid cancer and measure relative~     quantities of 1000s of proteins within the blood. These measures will be explored to see if,~     when used in combination they can accurately diagnose thyroid cancer. If successful this~     technique could be extended to routine screening and could replace more invasive tests~     currently used. Participants will be required to supply a small sample of blood, answer~     questions on their medical history and also consent for their medical records to be examined.~     A lifestyle questionnaire will also be supplied to each participant. In the case where a~     diagnosis is predicted for a condition the participant was not aware of the medical team will~     discuss the best interests of the patient with their GP and if required refer them to a~     suitable specialist. The study will run for 24 months and will routinely process around 15~     and 20 participants with a history of thyroid cancer per month. All patient details will be~     kept confidential and only non identifiable information will leave the clinic. The work will~     be published and if successful will be validated on another site, commercialised and made~     available for routine clinical use.~   "
151266|NCT01586507|"~     The purpose of this study is to compare the pharmacokinetic (PK) of single oral doses of~     ULTRAM Extended Release (ER) at 2 dose levels in adolescents between 12 and 17 years old,~     inclusive (up to 17 years 364 days) with pain due to injury or nonmalignant disease, to the~     PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic~     tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and~     how it is removed from the body over time.~   "
151267|NCT01586494|"~     The purpose of this study is to compare the pharmacokinetics (PK) of single oral doses of~     ULTRAM Extended Release (ER) at 2 dose levels in children between 7 and 11 years old,~     inclusive (up to 11 years 364 days) with pain due to injury or nonmalignant disease, to the~     PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic~     tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and~     how it is removed from the body over time.~   "
151268|NCT01586481|"~     It's a pilot prospective opened multicentric randomised study. We measure the efficiency and~     the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK)~     to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic~     patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis~     or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with~     BAROUK shoe~   "
151269|NCT01586468|"~     Objectives To assess the efficacy and safety of WF10 infusions in the treatment of subjects~     with persistent allergic rhinitis.~      Study Design Randomized, double-blind, placebo-controlled, parallel-group, single-centre~     trial.~      Subjects 50 subjects (25 per treatment group) with history of persistent allergic rhinitis~     for at least 2 years prior to enrolment and a positive allergen skin test. Subjects will be~     required to have a minimum mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS)~     (mean score of morning and evening reflective TNSS assessments for the 3 days prior to~     randomization and treatment.~      Treatments At the first treatment visit (T1), subjects that comply with the inclusion and~     exclusion criteria will be randomized into one of two treatment groups: WF10, or placebo.~      Each individual treatment dose of study drug solution is 0.5 mL/kg body weight, diluted into~     500 mL saline solution. Treatment will be administered once daily for 5 consecutive days~     (Visits T1-T5) via intravenous infusion.~   "
151270|NCT01586455|"~     The purpose of this clinical trial is to investigate the safety of human placental-derived~     stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in~     patients with various malignant or nonmalignant disorders who require a stem cell transplant.~     Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and~     immunotherapy followed by a stem cell transplantation with UCB and HPDSC.~   "
151271|NCT01586442|"~     In this proposal,the investigators will examine whether the selectivity of eplerenone for the~     MR will translate into a better glucose and metabolic profile compare to spironolactone in~     patients with HF with glucose intolerance or type 2 diabetes. In addition, the investigators~     will also compare the impact of these two agents on changes of concentrations of established~     prognostic biomarkers of neurohormonal activation and extracellular matrix turnover.~   "
151272|NCT01586429|"~     Post-operative pain following total knee replacement can be disabling and sometimes lead to~     the need for prolonged hospital stay. Therefore development of improved post-operative~     modalities for total knee replacement surgery pain control is important. High-resolution~     ultrasound (US) allows accurate visualization of nerves and surrounding structures and can~     lead to higher success rates of nerve block. The investigators aim at comparing the analgesic~     efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia for~     patients with knee OA who underwent unilateral total knee replacement.~   "
151273|NCT01586416|"~     The purpose of this study is to develop and pilot test a behavioral intervention for elderly~     adults in treatment for colon cancer, to enhance their skills for managing the challenges of~     completing chemotherapy regimens. The investigators will assess feasibility and acceptability~     of the intervention, and explore preliminary efficacy of the intervention for reducing~     psychological distress and improving rates of optimal chemotherapy adherence.~   "
151274|NCT01586403|"~     This is a phase one trial to determine if genetically engineered lymphocytes can be safely~     delivered to patients with metastatic melanoma.~   "
151275|NCT01586390|"~     In this study we compare two treatment options for ankle sprains. 100 patients were~     randomised between a flexible cast treatment and a removable and adjustable brace made out of~     the same materials.~      Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures~     were patient satisfaction scores with treatment as well as treatment result.~   "
151276|NCT01586377|"~     Recent clinical investigations have suggested that the cause of abnormal pain in complex~     regional pain syndrome could be ischemia and inflammation, due to poor blood flow to deep~     tissues from microvascular pathology. This study aims to determine if a new technology called~     near infrared spectroscopy can measure this microvascular dysfunction. The study hypothesizes~     that significant differences can be measured in the microcirculation of patients with CRPS-I~     using near infrared spectroscopy and the vascular occlusion test.~   "
151277|NCT01586364|"~     The objective of the study was to assess the long-term safety of daily doses of ospemifene 60~     mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a~     uterus.~   "
151278|NCT01586351|"~     The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix~     from Arthrex is possible with the arthroscopic technique.~   "
151279|NCT01586338|"~     Primary Objective:~        -  To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis Index~          (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score~        -  To evaluate the safety using the incidence, severity, seriousness, relatedness, and~          frequency of all treatment emergent Adverse Events (AEs)~      Secondary Objectives:~        -  To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks 8,~          and 12~        -  To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and 26~        -  To evaluate the change in Patient Global Assessment (PTGA) score between baseline and~          weeks 8, 12 and 26~        -  To evaluate the change in Clinical Observer Global Assessment (COGA) score between~          baseline and weeks 8, 12 and 26~        -  To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and~          between baseline and weeks 1, 2, 8, 12 and 26~   "
151280|NCT01586325|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (how a~     drug is absorbed and distributed in the body), and intrinsic antiviral activity of~     JNJ-47910382 after 5 consecutive days of administration in chronic, hepatitis C virus~     (HCV)-genotype-1-infected patients at different doses and dose regimens.~   "
151281|NCT01586312|"~     In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC),~     obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial~     is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We~     propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and~     controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay~     consists of two arms with 15 patients each one. Patients in the experimental arm will be~     given an intra-articular transplantation of allogenic MSC, expanded Ex Vivo with our~     GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as~     in NCT01183728). In the control arm a standard treatment with intra-articular injection of~     hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of~     life and quantitative changes in structure and composition of cartilage determined by~     T2-weighted MRI relaxation (Cartigram) for one year.~   "
151282|NCT01586299|"~     The purpose of this study is to evaluate the influence of routine NSAIDs treatment for~     hospitalized children with pleuropneumonia in comparison with acetominophen treatment (all in~     conjunction with adequate antibiotic therapy).~   "
151283|NCT01586286|"~     The objective of this study is to perform a randomized controlled trial among female patients~     with a diagnosis of pelvic floor hypertonus (extreme muscle tension) with associated pain,~     dysfunctional voiding, dyspareunia, and/ or obstructed defecation.~   "
151284|NCT01586273|"~     The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic~     Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating~     painful bone metastases.~   "
151285|NCT01586260|"~     The purpose of this research study is to evaluate a new investigational drug to prevent~     reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The~     objectives of this study will be to monitor for safety and look at efficacy of DFMO.~      The safety of the proposed dosing regimen in this trial will be tested by an on-going~     risk/benefit assessment during the study. A patient benefiting from treatment, not~     progressing on therapy, and in the absence of any safety issues associated with DFMO may~     continue on treatment up to 27 cycles with the expectation that there will be an overall~     clinical benefit.~      The procedures involved in this study include Medical history, Physical exam, Vital signs~     (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the~     tumor(s), MIBG scans, and Bone marrow aspirations. All of these tests and procedures are~     considered standard of care for this population. Drug administration is also part of this~     protocol, including an investigational new drug called DFMO.~      The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day~     while on study. There will be 27 cycles. Each cycle will be 28 days in length.~   "
151291|NCT01586182|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational intervention (in this case, the stereotactic radiation boost). Phase I~     studies also try to define the appropriate dose of the investigational intervention to use~     for further studies. Investigational means that the stereotactic radiation treatment is~     still being studied and that research doctors are trying to find out more about it. It also~     means that the FDA has not approved a stereotactic radiation boost for your type of cancer.~      In this research study, the investigators are looking for the highest dose of the~     stereotactic radiation boost that can be given safely. Because the stereotactic radiation~     boost is so precise, the investigators are testing whether it can be used to increase the~     dose to the primary tumor without significantly increasing the side effects you experience;~     the goal is to improve the likelihood of successfully treating the tumor.~   "
151292|NCT01586169|"~     The purpose of this study is to determine whether the triple co administration of~     albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that~     consists to treat with albendazole plus ivermectin together and a week later to treat with~     azithromycin in areas co endemic for lymphatic filariasis and trachoma.~   "
151293|NCT01586156|"~     Pulmonary arterial hypertension (PAH) is a progressive disease of the pulmonary vasculature~     leading to elevated pulmonary pressure and right ventricular (RV) dysfunction with heart~     failure. Measures of RV function are better predictors of mortality and long term outcomes~     than pulmonary vascular resistance. The interaction between RV function and the pulmonary~     circulation is not fully understood, but increased after load appears insufficient to explain~     right heart failure. Yet, all approved PAH therapies target vasodilation of the pulmonary~     vasculature to lower pressures~   "
151294|NCT01586143|"~     This is a clinical study that aims to investigate and compare the efficacy of transbuccal~     paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with~     acute pain of moderate intensity accepted to emergency room following a minor trauma of the~     lower limbs and/or superiors. To this end, several pain scoring will be performed using a~     visual analogue scale (VAS) at various times after drug administration.~   "
151295|NCT01586130|"~     Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs,~     especially the quadriceps; leading to disease progression. Advantages of muscular strength~     training for the treatment of this kind of O.A. is now well established. In this therapeutic~     field, isokinetic exercises seem to have a better efficiency than other, more frequently~     used, kinds of exercises such as isometric or isotonic exercises.~      Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces~     muscles to work in eccentric mode.~      The hypothesis of this study is that muscular strengthening using isokinetic exercises in~     eccentric mode would have a more important benefit than isokinetic exercises in concentric~     mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative~     knee exercises in the treatment of knee O.A.~   "
151296|NCT01586117|"~     The purpose of this study is to evaluate the effect of intrarectal Amifostine administration~     on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.~   "
151297|NCT01586104|"~     This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating~     younger patients with lung metastases. Specialized radiation therapy that delivers a high~     dose of radiation directly to the tumor may kill more tumor cells and cause less damage to~     normal tissue.~   "
151298|NCT01586091|"~     Primary objective:~      The comparative efficacy of levocetirizine 5 mg once daily with that of fexofenadine 60 mg~     twice daily against histamine induced wheal, flare and itch responses measured at 0~     (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours.~      Secondary objectives:~        1. The areas under the curves (0 , 12 hours, 12 - 24 hours and 0 - 24 hours) for inhibition~          of histamine induced wheal, flare and itch responses for levocetirizine 5 mg once daily~          and fexofenadine 60 mg twice daily.~        2. The number of individuals with peak responses in each 10 percentile (Because of the~          variable absorption of fexofenadine, it is predicted that fexofenadine will have a~          variable response between individuals).~        3. The mean plasma levels of levocetirizine and fexofenadine at 0 (baseline), 0.5, 1, 2, 3,~          4, 6, 8, 10, 12 and 24 hours.~   "
151299|NCT01586065|"~     The purpose of this study is to see if children and adolescents with poorly controlled type 1~     diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be~     used to check blood sugars.~   "
151300|NCT01586052|"~     This purpose of this phase 1 study is to investigate the safety and efficacy of erythropoetin~     for children with cerebral palsy.~   "
151301|NCT01586039|"~     The timing and quality of sleep is governed by environmental and physiologic factors.~     Environmental factors, especially ambient lighting can impact the circadian system and alter~     the timing and structure of sleep. Light exposure can also acutely alter neural activation~     state and impair sleep. These effects all demonstrate marked sensitivity to short-wavelength~     blue light with maximal sensitivity in the 460-480 nm range. The alerting effects of blue~     light in the evening persist for at least 3-4 hours after the lights are turned off, and can~     disturb subsequent sleep. Avoiding these deleterious effects of light exposure prior to sleep~     on subsequent sleep would be beneficial to sleep quality and potentially health.~      The investigators will compare the effects of two light sources, equated for visual stimulus~     (lux), on multiple non-visual responses to light. The investigators will compare a 90 lux~     exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white~     light source that is depleted in the short-wavelength visible range (Biological Illumination~     LCC, FL). In a within-subject design, the investigators will test the hypotheses that~     exposure as compared to a CFL 90 lux exposure 90 lux of the blue-depleted LED will cause~     significantly:~        1. Less melatonin suppression between melatonin onset and bedtime;~        2. Less subjective and objective alerting responses before bedtime;~        3. Less disruption of nocturnal sleep structure and quality.~   "
151302|NCT01586026|"~     This study is to compare the rate of adverse events in subjects with maintenance flushes~     greater than 28 days.~   "
151303|NCT01586013|"~     This study obtains an effect site model for White (Modified Marsh) pharmacokinetic propofol~     model. The plasma effect-site rate constant (ke0) obtained is affected by age.~   "
155882|NCT01525797|"~     The purpose of this study is to see what a lab test will show and if there is a way to~     predict which patients will be more likely to have rejection after receiving a liver~     transplant.~   "
151304|NCT01586000|"~     This clinical trial is an experimental research study using a potential new form of birth~     control. Clinical trials include people who volunteer to take part in a study. Take your time~     to decide if you want to be part of this experimental research study. If you want to know~     more about this study first, ask the study doctor or study site staff. The investigators can~     also give you the study information written for doctors and clinic staff.~   "
151305|NCT01585987|"~     The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as~     sequential or maintenance treatment immediately after first-line chemotherapy in the~     treatment of unresectable or metastatic gastric and gastro-esophageal cancer.~   "
151306|NCT01585974|"~     This study is a prospective, non-interventional, non-controlled, multi-center, observational~     cohort study. The medication is prescribed within the regular practice of the physician.~     Duration and dosage of treatment is solely at the discretion of the attending physician. The~     primary objective of this study is to assess duration of treatment in Turkish renal cell~     carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate~     prior cytokine treatment within the first month of treatment.~   "
151307|NCT01585961|"~     This is a prospective, interventional, observational, unblinded, single-arm, multicenter~     registry of younger and older subjects with drug refractory, recurrent, symptomatic~     paroxysmal atrial fibrillation.~   "
151308|NCT01585948|"~     In the present study the investigators will measure the extent of coronary artery disease via~     coronary angiography and the correlating risk factors.~   "
151309|NCT01585935|"~     Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot~     immediately be nourished with mother´s or formula milk and are typically dependent on~     parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for liver~     complications of PN, namely parenteral nutrition associated cholestasis (PNAC).~      Intravenous lipid emulsions (ILE) based on soy bean oil are standard of care for provision of~     energy and essential fatty acids in preterm infants. However, they might be implicated in the~     pathogenesis of PNAC.~      ILEs based on pure fish oil are proposed for therapy of PNAC. Recently a lipid emulsion~     containing 15 % fish oil together with soy bean, olive and MCT oil has become available in~     Europe (SMOFLIPID®). Such a balanced lipid emulsion might be more favourable than the~     standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore~     ILEs containing fish oil might exert a positive effect on neurodevelopment. However, there~     are no data so far.~      The study aims to evaluate the fish oil containing ILE SMOFlipid® for its protective effect~     against PNAC in ELBW infants compared to standard treatment with the soy bean based ILE~     Intralipid®. Furthermore neurodevelopment at 12 and 24 months of corrected gestational age~     will be investigated.~   "
151310|NCT01585922|"~     In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on~     decreasing inflammatory response, improving the pathophysiological manifestation and reducing~     the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS)~     patients, the investigators conduct this clinical trial comparing NPPV with invasive~     mechanical ventilation in more than twenty ICUs in China.~   "
151311|NCT01585909|"~     The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in~     preventing invasion of gastrointestinal bacteria.~   "
151312|NCT01585896|"~     The proposed study aims to investigate the efficacy of a facilitated self-help group for the~     treatment of hoarding disorder. Eligible participants will take part in a facilitated~     self-help group. The investigators aim to investigate the effects of a self-help group on~     hoarding symptoms. The investigators hypothesize that participants will demonstrate decreased~     hoarding symptoms over time.~   "
151313|NCT01585883|"~     The purpose of this study is to investigate the suitability and practicality of a coaching~     and support intervention in helping patients to use daily strategies for managing~     breathlessness. Also, the investigators will try to understand how useful it is in helping~     patients to reduce intensity of breathlessness and its impact their quality of life.~   "
151314|NCT01585870|"~     This Phase 1 study will be conducted in an open-label, non-randomized, dose-escalation design~     in subjects with advanced, metastatic or refractory solid malignancy who are not candidates~     for standard therapy. The study drugs are sorafenib and eribulin mesylate.~      Up to 24 subjects with solid tumors will participate in the dose escalation part of the~     study, and once the maximum tolerated dose is defined, up to 30 subjects with advanced,~     metastatic or refractory solid tumors will participate in the expansion phase of the study.~      Eribulin (mesylate) will be administered intravenously at a fixed dose of 1.4 mg/m2 on Days 1~     and 8 of 21-day Cycles.~      The starting sorafenib dose (Dose Level 1) is 200 mg twice daily. Sorafenib is given orally,~     continuously on days 11 to 21 of Cycle 1, and from Day 1 to Day 21 of all subsequent cycles.~     If 200 mg sorafenib twice daily is tolerated with eribulin, the sorafenib dose will be~     escalated sequentially to 200 mg morning dose and 400 mg evening dose (Dose Level 2) in a new~     cohort. If Dose Level 2 is tolerated, a second dose escalation to 400 mg twice daily (Dose~     Level 3) will be studied in a new cohort. If the starting dose of sorafenib is not tolerated~     with eribulin, the sorafenib dose will be de-escalated to 200 mg once daily in a new cohort.~     Subjects will need to receive two cycles of eribulin plus sorafenib therapy and safety data~     for the first and second cycle needs to be available before the start of the next cohort.~   "
151315|NCT01585857|"~     Primary:~      To study the safety of a single injection of autologous adipose derived mesenchymal stromal~     cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).~      Secondary:~      To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal~     cells on patients with moderate or severe osteoarthritis of the knee (OA).~   "
151326|NCT01585701|"~     The purpose of this first clinical study of the noval multiple AGC kinase inhibitor, AT13148,~     is to identify the recommended dose for future studies in cancer patients by exploring the~     safety and maximum tolerated dose and biological effects in patients with advanced solid~     tumours.~   "
151327|NCT01585688|"~     The primary objectives are to evaluate the safety and tolerability of hLL1-DOX, and to~     determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated~     dosing schedule). The secondary objectives are to obtain information on efficacy,~     pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for~     subsequent studies.~   "
151316|NCT01585844|"~     Obstructive sleep apnea is known to be a significant source of morbidity in the general~     population. It has been proposed to be associated with the development of preeclampsia and~     fetal growth restriction. As these are conditions that have long term maternal and neonatal~     implications, further information may help improve maternal/fetal outcome. One reason why~     women and in particular pregnant women are under diagnosed is the lack of an effective,~     reliable screening tool. Validated questionnaires used in the general population may not be~     effective in screening pregnant women. The investigators hypothesize that sleep apnea will~     have 20% prevalence in the obese pregnant population and that it is associated with increased~     maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their~     prenatal care clinics and they will be screened for OSA using validated sleep questionnaires~     including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The~     subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea~     detection device. Women who meet clinical criteria for OSA will be referred for overnight~     polysomnogram and management by the Pulmonary and Critical Care Division of the Internal~     Medicine Department. For all enrolled patients the remainder of prenatal care will be per~     routine. Data will be collected regarding the pregnancy course and outcomes.~      The primary outcome of interest is the prevalence of sleep apnea in obese women and the~     associated maternal and neonatal morbidity. The secondary outcome measures will be molecular~     measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep~     apnea.~   "
151317|NCT01585831|"~     The purpose of this study is to determine if testosterone replacement therapy leads to~     changes in psychological factors and/or motor skills in adolescent males with 47,XXY (also~     called Klinefelter syndrome). This study will also evaluate whether certain genetic factors~     of the X chromosome affect the psychological or motor features of XXY/Klinefelter syndrome.~   "
151318|NCT01585818|"~     Lifestyle modification, in particular adopting an appropriate dietary pattern, is generally~     accepted as the cornerstone for the treatment of people with type 2 diabetes mellitus (T2DM).~     Consumption of low glycaemic index (GI) meals have been shown to improve glycaemic control,~     lipid profile and reduced systemic inflammation. However, these studies and international~     evidence-based nutritional recommendations are principally based on people of European~     ethnicity consuming fairly typical western diets. There are few published controlled~     dietary intervention studies which have attempted to determine appropriate dietary patterns~     for the treatment of diabetes amongst populations consuming rice-based diets.~      HYPOTHESIS~        1. The glycaemic response over 6 days as measured by CGMS will have a lower mean glucose~          level and postprandial increase in individuals consuming the LGI compared with the SDI~          meal plan.~        2. A LGI meal plan is acceptable and participants will adhere and comply to the diet to the~          same level as those receiving the SDI meal plan.~        3. Glycaemic and metabolic parameters as measured by integrated area under the curve (IAUC)~          of glucose and insulin are lower after a single meal comprising of LGI than compared~          with an SDI meal.~        4. The effect of a single meal of LGI reduces appetite and increases satiety compared with~          a meal of SDI.~   "
151319|NCT01585805|"~     This randomized phase II trial studies how well veliparib together with gemcitabine~     hydrochloride and cisplatin works compared to gemcitabine hydrochloride and cisplatin alone~     in treating patients with pancreatic cancer that has spread from where it started to nearby~     tissue or lymph nodes (locally advanced) or spread from the primary site (place where it~     started) to other places in the body (metastatic). Veliparib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. It is not yet known whether giving veliparib together with gemcitabine~     hydrochloride and cisplatin is an effective treatment for pancreatic cancer.~   "
151320|NCT01585792|"~     The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in~     diabetic patients.~   "
151321|NCT01585779|"~     The purpose of this study is to gather clinical information on the hemodynamic performance of~     the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.~   "
151322|NCT01585766|"~     The purpose of this study is to evaluate the safety and tolerability of ascending intravenous~     (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of~     multiple sclerosis (MS).~   "
151323|NCT01585753|"~     This is a substudy of MARCH, in which we are exploring the changes in the vascular~     endothelium using pulse wave tonometry (a non invasive measure of cardiac health) to measure~     the changes in small and large arterial elasticity in participants of the MARCH study who~     switch to maraviroc-based regimens over 96 weeks of follow-up.~   "
151324|NCT01585740|"~     The objective of this study is to compare the effect on mean maternal and neonatal pH, and~     24-hour postoperative morbidity, following intraoperative infusion of Ringer's Lactated~     versus normal saline in caesarean section at Mulago Hospital.~      The null hypothesis is that intraoperative infusion of Ringer's Lactate in caesarean section~     at Mulago Hospital will not result in 30% less mean maternal and neonatal pH change than~     intraoperative infusion of normal saline.~   "
151325|NCT01585727|"~     One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is~     the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for~     diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying~     degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal~     cancer despite potentially nerve-sparing total mesorectal excision (TME).~      The study will examine the impact of a newly developed continuous monitoring device for~     preservation of urogenital function in patients with TME for rectal cancer. 188 patients will~     be included in the prospective, randomized, single-blind, parallel group multi-centre trial~     including two arms (TME with and without intraoperative continuous monitoring of pelvic~     autonomic nerves). The primary efficacy endpoint is the change in urinary function measured~     by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions~     measured as secondary endpoints. The application of the continuous intraoperative~     neuromonitoring device could enhance the objective intraoperative confirmation of pelvic~     nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes~     the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An~     enormous reduction of treatment costs is to be expected.~   "
151328|NCT01585675|"~     The primary objective of the protocol is to develop a comprehensive specimen banking program~     from patients with lung cancer for future translation research, which will enable the~     investigators to detect lung cancer earlier, develop better therapies and explore screening~     and prevention strategies.~   "
151329|NCT01585662|"~     EUS-guided pseudocyst drainage has been used world widely. Now, most endoscopists tend to~     place several stents to drain the content of cyst into GI tract. In the investigators~     experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than~     placement of stents. Moreover, none of pseudocysts(total 19) drained by this modified~     naso-pancreatic tube drainage method were found recurrent with a follow up period from 3~     months-34 months. So, the investigators designed this prospective random comparing study to~     confirm the result.~   "
151330|NCT01585649|"~     This is a Phase I, open label study aimed at assessing the pharmacokinetics,~     pharmacodynamics, the efficacy, safety, and tolerability of a single injection of XM22 in~     children with Ewing family of tumors or rhabdomyosarcoma scheduled to receive chemotherapy~     (CTX)~   "
151331|NCT01585636|"~     This is a phase 1, first in man study to evaluate single oral doses (5-300 mg) of SQ109, a~     new investigational drug being developed for treatment of tuberculosis. If single doses are~     safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy~     volunteers and patients with pulmonary tuberculosis.~   "
151332|NCT01585623|"~     Primary Objective:~        -  To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome~          P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).~        -  To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.~      Secondary Objectives:~        -  To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in~          Segment 1~        -  To characterize the safety and tolerability of 28-day consecutive doses of 500 mg~          SAR302503 in Segment 2~        -  To determine antitumor activity in Segment 2~   "
151333|NCT01585610|"~     The purpose of this study is to determine if a newly designed DVD program performs better~     than standard, printed quit-smoking materials to help smokers who have mobility limitations~     (e.g., use a cane, wheelchair, braces, crutches, prosthesis) to quit smoking.~   "
151334|NCT01585597|"~     The purpose of this study is to determine whether reducing a patients body temperature (mild~     hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury~     (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a~     significant interruption of blood flow to an area of brain (occlusion of large proximal~     cerebral artery) and have undergone successful removal of that interruption~     (revascularization).~   "
151335|NCT01585584|"~     The purpose of this study is to test the potential antiviral efficacy of triple-combination~     therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype~     3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).~   "
151336|NCT01585571|"~     The results of this study will have an impact upon public heath policy as adults with~     cerebral palsy (CP) present a growing and underserved population in the United States. At the~     conclusion of this study, we will have identified the means by which the adult with CP~     maintains their upright position, which is essential for activities of daily living and for~     movement. With this knowledge, it will be possible to develop clinical and rehabilitation~     interventions that will improve their arm and leg function, and reduce the risk of falls for~     the adult with CP.~   "
151337|NCT01585558|"~     The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily~     doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal~     women with an intact uterus.~   "
151338|NCT01585545|"~     The purpose of this study is to evaluate relationships between multiparametric imaging~     biomarkers and genetic analysis in NSCLC patients.~   "
151339|NCT01585532|"~     Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis~     specific nucleic acid in urine and blood of patients.~   "
151340|NCT01585519|"~     This study will examine if health benefits of consuming nutrient-rich apples, an apple~     extract and freeze dried apple product will be similar. 50 volunteers at increased risk of~     heart disease will consume either a low apple diet (<1 portion/d), 2 high or low polyphenol~     apples/day, an apple extract, or freeze dried apple granule product for 4 weeks (ten~     participants per group, randomly assigned). Apart from the extract group, all volunteers will~     consume a placebo. All volunteers will follow a low apple diet (<1 apple per day) other than~     what has been provided by the research team. Volunteers will complete food diaries at the~     start and end of the study and a number of questionnaires. Blood and urine samples collected~     at 0 and 4 weeks~   "
151341|NCT01585506|"~     This study is conducted in Europe. The aim of this study is to investigate psychosocial~     factors related to compliance with treatment with biphasic insulin analogues.~   "
151342|NCT01585493|"~     Schizophrenia is a life shortening disease, not only because of suicide but also because of~     increased mortality from natural causes. Recently, a large register-based study, involving~     complete national data from Denmark, Sweden and Finland, showed that life expectancy for~     schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the~     general population, and that mortality from medical conditions and diseases are responsible~     for a large proportion of the reduced life expectancy. Patients with schizophrenia had a~     twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases,~     lung cancer and metabolic conditions. Unhealthy life style and undetected and untreated~     physical disorders play an important role in this excess mortality.Results from the Danish~     National Indicator Project for Schizophrenia showed that a much higher proportion of patients~     with schizophrenia compared to the general population have measures of waist circumference,~     body mass index, blood pressure, blood lipids and blood glucoses above the recommended upper~     values.~      In the randomized clinical trial CHANGE, the investigators will evaluate the effect of two~     different interventions both aiming to reduce risk for death from medical diseases. We will~     compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to~     connect the patient to general practice and primary care and 3) affiliation to a staff member~     from the CHANGE team who should facilitate life style changes and contact with general~     practice. The objective is to identify interventions that can reduce the risk of early death~     in patients with schizophrenia.~   "
151343|NCT01585480|"~     The purpose of this research study is to develop, implement, and evaluate a multi-component~     obesity prevention program in a workplace setting. A quasi-experimental design will be~     utilized, with hospital employees receiving the intervention and clinic employees serving as~     the comparison group. It is hypothesized that the intervention group will see greater changes~     in healthier eating, increased participation in physical activity, and reduced risk for~     obesity (weight, BMI, waist circumference).~   "
151344|NCT01585467|"~     To compare and validate the two clinical algorithms~   "
151345|NCT01585454|"~     Background:~      - Women can gain too much weight or develop diabetes during pregnancy. If the mother is~     overweight or has diabetes during pregnancy, her baby may also be at risk of being overweight~     or developing diabetes. A woman s chance of getting diabetes increases if her parents or~     family members are overweight or have diabetes. Poor diet and exercise habits can also lead~     to weight gain and diabetes. Researchers want to study how best to improve the health of~     pregnant women and their children. They will do so by providing healthy lifestyle counseling~     for women receiving prenatal care at the Phoenix Indian Medical Center.~      Objectives:~      - To study the effectiveness of healthy lifestyle counseling for overweight and/or diabetic~     pregnant women.~      Eligibility:~        -  Women at least 18 years of age who will receive pregnancy care at the Phoenix Indian~          Medical Center.~        -  Participants must be overweight or obese. They may or may not have diabetes.~      Design:~        -  Participants will receive standard prenatal care from the midwives, doctors, and~          dietitians at the Phoenix Indian Medical Center.~        -  Participants will work with National Institutes of Health staff for about 2 hours every~          week. These sessions may include phone calls, home visits, or group meetings.~        -  Participants will have a total of nine measurement visits. The first visit will be at or~          before 16 weeks of pregnancy. The next three visits will be within a week of the first~          visit. Another four visits will take place between 23 and 28 weeks of pregnancy.~        -  Participants will have different tests through their pregnancy. They will wear heart~          monitors and wrist monitors to measure heart rate and movement. They will provide~          information on their eating habits, physical activity, and mood and feelings during~          pregnancy. Blood samples will be collected to measure blood glucose (sugar) levels.~        -  Participants will receive counseling on healthy eating and physical activity habits.~          They will be encouraged to invite friends or family members to learn more about healthy~          lifestyle choices.~        -  The study will end with the final visit about 6 to 8 weeks after giving birth. A final~          blood sample will be collected. Participants will be asked questions about mood and~          feelings.~   "
151346|NCT01585441|"~     Background:~        -  Central serous chorioretinopathy (CSC) is a disease that causes fluid to collect under~          the retina. It affects the macula, which is in the center of the retina and is needed~          for sharp, clear vision. In many cases, CSC resolves on its own and does not need~          treatment. However, in some cases it does not go away or comes back after treatment.~          This is known as chronic CSC.~        -  Chronic CSC may be caused by hormones called androgens. Finasteride is a drug that can~          alter the effects certain of androgens. Researchers want to compare finasteride with a~          placebo to see if it is a safe and effective treatment for chronic CSC.~      Objectives:~      - To see if finasteride is a safe and effective treatment for chronic CSC.~      Eligibility:~      - Individuals at least 18 years of age who have chronic CSC in one or both eyes.~      Design:~        -  Participants will be screened with a physical exam and medical history. A full eye exam~          will be performed. Blood and urine samples will also be collected.~        -  Some participants may have photodynamic therapy (PDT), the standard treatment for CSC.~          PDT helps to reduce the amount of fluid in the eye. Participants will need to wait for 3~          months after PDT before starting the finasteride study.~        -  Participants will be separated into two groups. One group will take finasteride 5 mg~          (formulated into capsules); the other group will take a placebo capsule. All~          participants will take the capsules for 3 months.~        -  After 3 months on the assigned capsule (finasteride or placebo), all participants will~          have the opportunity to take finasteride for at least another 4 years and 9 months. This~          phase of the study is optional.~        -  Participants will have regular study visits. At each visit, they will have physical~          exams and eye exams. They will also provide blood and urine samples.~        -  During the first 3 months, participants will have 2 study visits. After 3 months, if the~          participant continues in the optional (or as needed) phase of the protocol, visits will~          occur at Month 6, Month 12 and every 12 months thereafter. However, additional visits~          may be needed.~   "
151347|NCT01585428|"~     Background:~      The human papillomavirus (HPV) can cause a number of cancers, including cervical and throat~     cancers. The National Cancer Institute (NCI) Surgery Branch has developed an experimental~     therapy that involves taking white blood cells from patients' tumors, growing them in the~     laboratory in large numbers, and then giving the cells back to the patient. These cells are~     called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to~     over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people~     with human papilloma virus (HPV)-related cancer. In this study, we are selecting a specific~     subset of white blood cells from the tumor that we think are the most effective in fighting~     tumors and will use only these cells in making the tumor fighting cells.~      Objective:~      The purpose of this study is to see if these specifically selected tumor fighting cells can~     cause HPV-related cancers to shrink and to see if this treatment is safe.~      Eligibility:~      - Adults age 18-66 with HPV-related cancer who have a tumor that can be safely removed.~      Design:~      Work up stage: Patients will be seen as an outpatient at the National Institutes of Health~     (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab~     tests, and other tests as needed.~      Surgery: If the patients meet all of the requirements for the study they will undergo surgery~     to remove a tumor that can be used to grow the TIL product.~      Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells.~     {Leukapheresis is a common procedure, which removes only the white blood cells from the~     patient.}~      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the~     conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for~     about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.~   "
151348|NCT01585415|"~     Background:~      - One possible treatment for advanced melanoma involves collecting white blood cells from the~     person with cancer and growing them in a laboratory. The cells can then be given back to the~     donor. This study will use this white blood cell treatment with the cancer treatment drug~     vemurafenib. Vemurafenib targets melanoma cells that have a mutation in the B-raf gene, and~     may be able to make them shrink.~      Objectives:~      - To see if vemurafenib and white blood cell therapy is a safe and effective treatment for~     advanced melanoma.~      Eligibility:~      - Individuals at least 18 years and less than or equal to 66 years of age who have advanced~     melanoma that contains the B-raf genetic mutation.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  White blood cells will be collected from tumor cells. These cells will be collected~          during surgery or a tumor biopsy.~        -  Participants will have leukapheresis to collect additional white blood cells for the~          procedure.~        -  Participants will take vemurafenib twice a day, starting 3 weeks before receiving the~          white blood cells.~        -  Participants will have 1 week of chemotherapy to prepare their immune system to accept~          the white blood cells.~        -  Participants will receive an infusion of their collected white blood cells. They will~          also receive aldesleukin for up to 5 days to boost the immune system s response to the~          white blood cells. They will remain in the hospital until they have recovered from the~          treatment.~        -  Participants will have frequent follow-up visits to monitor the outcome of the~          treatment.~   "
151362|NCT01585220|"~     This study design is a randomized, multi-center, double Masked, matched Pairs,~     active-controlled clinical trial. Subjects who voluntarily signed the informed consent and~     are judged to be eligible for this study will be intradermally injected both of study device~     and comparator device. Subjects will be randomized to receive injection of study device and~     comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in~     Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks~     follow up visits and subject diary which will be given to subjects during the first 2 weeks~     after the injection. Any uncomfortable things and adverse events will be investigated from~     subeject diary and follow up visits.~   "
151363|NCT01585207|"~     The purpose of this study is to determine if vigabatrin, an unusual anti-seizure medication,~     will diminish the Tourette Disorder outbursts in young adults whose symptoms have persisted~     into adulthood and have not responded to usual treatment.~   "
151349|NCT01585402|"~     Background:~        -  Arterial Calcifications due to Deficiency in CD73 (ACDC) is a rare genetic disease.~          People with ACDC develop calcium deposits in the arteries and joints of the fingers,~          wrists, ankles and feet. These deposits cause severe pain in the hands and feet, even~          when the person is at rest, and may lead to loss of the affected hand or foot.~          Currently, there are no standard treatments for ACDC.~        -  Etidronate is a drug that helps to slow or stop the natural process that dissolves bone~          tissue. It is approved to treat Paget s disease, a condition in which the bones are soft~          and weak and may be deformed, painful, or easily broken. It is also used to treat high~          blood calcium levels. Researchers want to see if it can be used to treat the symptoms of~          ACDC and improve pain and blood flow in the hands and feet.~      Objectives:~      - To see if etridronate is a safe and effective treatment for ACDC.~      Eligibility:~      - People between 18 and 80 years of age who have been diagnosed with ACDC.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have imaging studies, including x-rays and DEXA bone scans, before starting treatment.~          Blood and urine samples will be collected. An exercise tolerance test will also be~          given.~        -  Participants will take etridronate by mouth once a day for 14 days every 3 months. They~          will be assigned an individualized 6-month drug schedule to follow. Participants should~          not eat foods that are high in calcium for at least 2 hours after taking the study drug.~        -  Participants will have regular study visits throughout the treatment period. These~          visits will involve imaging studies, full dental exams, and blood and urine tests.~          Participants will also have exercise tolerance tests and arm and leg blood pressure~          tests to measure pain and blood flow.~        -  Participants may also provide tissue samples for further study.~        -  Treatment will continue for up to 3 years as long as the side effects are not severe and~          the condition does not become worse. Participants will have a final follow-up visit~          after stopping treatment.~   "
151350|NCT01585389|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to brain tumors.~      PURPOSE: This research studies gene expression and location in samples from patients with~     brain tumors.~   "
151351|NCT01585376|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and find biomarkers related to~     cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies genes in samples from younger patients with~     rhabdomyosarcoma.~   "
151352|NCT01585350|"~     The purpose of this study is to learn the effects an experimental vaccine (MELITAC 12.1)~     combined with other substances called lipopolysaccharide (LPS; endotoxin), polyICLC, and~     Montanide ISA-51. The LPS, polyICLC, and Montanide ISA-51 are included with the vaccine to~     test whether they have an effect on the MELITAC 12.1 vaccine. The study will also look at~     whether the experimental vaccine and these drugs cause any changes to the immune system.~   "
151353|NCT01585337|"~     The hypotheses of this study are as follows:~        1. There is no significant muscle activity difference of each muscle in patients between~          pre and post operation.~        2. There is no significant forward reach distance/average velocity difference in patients~          between pre and post operation.~        3. There is no significant standard deviation of center of pressure (COP) along x axis,~          speed of COP along y axis during the task and COP path during the 3-sec holding phase~          difference in patients between pre and post operation.~        4. There is no significant muscle activity difference between muscles on both sides at post~          operation.~   "
151354|NCT01585324|"~     This open-label, multicenter, phase IV study will evaluate the relationship between the drop~     in hemoglobin levels and sustained virological response in patients with chronic hepatitis C~     genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients~     will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously~     weekly. Anticipated time on study treatment, depending on virological response, will be 48 or~     72 weeks.~   "
151355|NCT01585311|"~     The purpose of this retrospective study is to test the hypothesis that uncontrolled~     tachycardia serves as a risk factor for adverse cardiovascular events and poor outcome after~     Subarachnoid Hemorrhage (SAH).~   "
151356|NCT01585298|"~     Study to evaluate bradycardiac events during first dose observation of fingolimod in MS~     patients~   "
151357|NCT01585285|"~     The purpose of the AMI-PONT trial is to assess whether the results in term of graft patency~     with a novel coronary artery bypass (CABG) strategy, including a saphenous vein bridge to~     distribute the arterial flow of the left anterior mammary artery (LIMA) to all the~     anterolateral territory, are not inferior than a conventional CABG strategy combining~     separated LIMA graft to left anterior descending coronary and vein graft for other target~     vessels of the anterolateral territory.~   "
151358|NCT01585272|"~     This phase IIIb study is intended to implement a consistent treatment way for switching to~     Exelon transdermal patch from oral formulation of rivastigmine to stress the importance of~     (1) advantages of transdermal patch over conventional oral therapies: smooth drug delivery~     with reduced side effects;(2) encourage treatment compliance in the Alzheimer's dementia~     setting.~      This study is a single-arm, treatment-switched design. Eligible patients, who are under~     Exelon capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed~     by treatment switch from oral capsule to patch for 48 weeks maintenance treatment. During the~     maintenance period, the treatment will be initiated with Exelon Patch 4.6 mg/24 hours (Exelon~     Patch 5 cm^2) for the first 24 weeks and the dose will be escalated to Exelon Patch 9.5 mg/24~     hours (Exelon Patch 10 cm^2) for another 24 weeks if well tolerated. Visits to assess safety~     are scheduled at baseline, 3 days, 1 week and 2 weeks after the first treatment switch, every~     4 weeks until Week 40, and at the end of study (Week 52). The assessment to address the~     primary objective will focus on the safety of treatment switching (Week 0~28); however the~     safety assessment will be performed during the whole study period.~   "
151359|NCT01585259|"~     Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction~     patients~   "
151360|NCT01585246|"~     The aim of this study is to test whether Saw Palmetto, is useful in preventing or reducing~     the side effects for men undergoing radiation therapy for prostate cancer. Urinary symptoms~     will be recorded each week, as well as assessment of quality of life through: 1) Physical~     Well-Being 2) Social/Family Well-being 3) Emotional Well-Being, and 4) Functional Well-Being.~   "
151361|NCT01585233|"~     The purpose of this study is to explore the safety and tolerability of multiple doses of~     ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects~     with moderate to severe psoriasis.~   "
151395|NCT01584778|"~     Eosinophil cationic protein (ECP) is a matrix protein of eosinophils and has been reported to~     reflect eosinophil activity. Few studies have examined the role of eosinophils in the~     pathogenesis of Behçet's disease. The purpose of the present study is to investigate the~     serum ECP levels in BD and its relation to clinical activity.~   "
176608|NCT01253499|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     TRx0037 after multiple doses in elderly volunteers.~   "
151364|NCT01585194|"~     The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to~     control uveal melanoma.~      Ipilimumab is designed to increase the immune system's ability to fight cancer.~      Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow the~     body's immune system to work against tumor cells.~      This is an investigational study.~      Ipilimumab is FDA approved and commercially available to treat metastatic melanoma, including~     uveal melanoma. Nivolumab is FDA approved and commercially available to treat metastatic~     melanoma, including uveal melanoma, that has gotten worse while taking ipilimumab. Combining~     these 2 drugs to treat of uveal melanoma is investigational.~      Up to 39 patients will take part in this study. All will be enrolled at MD Anderson.~   "
151365|NCT01585181|"~     The purpose of this study is to compare the safety and immunogenicity of a single dose of the~     PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200,~     which is a live attenuated bacteria, can be transmitted to other adults living in the same~     household.~   "
151366|NCT01585168|"~     This project compares Family History Positive (FHP) for alcoholism subjects to matched Family~     History Negative (FHN) subjects derived from the project Principal Investigator's National~     Institute on Alcohol Abuse and Alcoholism-funded longitudinal study of drinking behavior in a~     2000 college freshman population (known as the Brain and Alcohol Research in College Students~     study (BARCS)). The age of these subjects is a valuable one at which to capture the~     transition from harmful use to abuse/dependence. This project explores the effects of~     memantine in a double-blind, randomized, counterbalanced manner on alcoholism risk-relevant~     tasks. More specifically, this project studies functional MRI tasks related to different~     aspects of reward and/or impulsivity-related behavior in different contexts, compares the~     underlying neural circuitry across tasks, and uses a pharmacologic probe of the glutamatergic~     system to examine NMDA/DA interactions. The combined measures provide the opportunity to~     advance our understanding of specific aspects of brain function related to familial~     alcoholism vulnerability in an already well-characterized population as some members evolve~     into alcohol abuse. In addition to conventional within-task analyses, functional network~     connectivity and allied approaches will be used to examine brain networks across tasks.~      The investigators will study adult male and female subjects in equal numbers who are either~     offspring of an alcoholic parent or are FHN matched controls. The investigators will recruit~     and assess a total of 84 (42 FHP and 42 matched FHN) subjects between the ages of 18-21 years~     on initial BARCS contact. The investigators will use 4 cognitive tasks during the functional~     MRI (fMRI) which include: 1) a Monetary Incentive Delay Task that distinguishes networks~     engaged in motivational (anticipation) and consummatory (outcome) components of reward~     processing; 2) a Go/No-Go Task that measures the ability to inhibit response to a pre-potent~     stimulus; 3) an Alcohol Cue Reactivity Task that examines Nucleus Accumbens response to~     alcohol-related versus matched soft drink stimuli; and 4) a Pavlovian-to-Instrumental~     Transfer (PIT) Task that dissects a component of the Monetary Incentive Delay (MID) Task, and~     provides an imaging assay of a transfer-like process that can be related to real-world~     drinking behavior, thus informing upon and extending the key findings from CTNA-2.~   "
151367|NCT01585155|"~     The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity~     index (CAI) score and other evaluation indicators in pediatric patients with moderate to~     severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2,~     and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also~     evaluated.~   "
151368|NCT01585142|"~     The purpose of this study is to assess the growth of infants fed with BabyNes System,~     compared to the World Health Organization Reference, during the first four months of life.~   "
151369|NCT01585129|"~     To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for~     pregnancies with treated chorioamnionitis.~   "
151370|NCT01585103|"~     Whether the cytosponge will be a useful non-invasive tool in evaluating patients with~     eosinophilic esophagitis?~   "
151371|NCT01585090|"~     Strengthening exercises of Pelvic Floor Muscles (PFM) is the first line treatment for female~     pelvic floor dysfunction. Actually the best position to facilitate PFM force is controversial~     in different studies. The aim of this study is to assess the effect of ankle positions on~     pelvic ﬂoor muscle force during PFM exercises.~      This clinical trial study was carried out on 58 women aged 25-55 years with relaxation of~     pelvic floor muscles who referred to women's clinic of educational hospitals of Mashhad~     University of Medical Sciences in 1389. After clinical examination and confirmation of pelvic~     floor muscle relaxation, women were randomize divided into 3 groups, doing strengthening~     exercises of PFM in standing position with passive ankle dorsi ﬂexion (on wooden surface with~     15 degree angle)(n=20), active ankle plantar ﬂexion with arm up (standing on toe)(n=20) and~     horizontal standing position (n=19) for 8 weeks. PFM exercises were instructed to women by~     using a pamphlet and face to face education. They were followed up every two week by~     telephone call and were asked to refer to women's clinic after 4 & 8 weeks. Pelvic floor~     muscles strength was assessed with brink score before and after intervention. Data analyzed~     by using analytic-descriptive statistics.~   "
151372|NCT01585077|"~     This study is a randomized clinical trial designed to compare the susceptibility of naive and~     pre-immune volunteers to infectious challenge with viable Plasmodium vivax sporozoites. The~     term preimmune hereafter denoted only previous experience with infection by this parasite and~     not a definite state of immunity to malaria infection. The study hypothesis is that~     pre-immune volunteers present a delayed onset of malaria clinical and parasitological~     manifestations when compared to naive individuals. The development of this study will~     establish a protocol for evaluating the effectiveness of vaccine candidates against P. vivax~     in subsequent Phases IIa and IIb clinical trials.~   "
151373|NCT01585064|"~     The purpose of this trial is to assess the effect of two Intensive Outpatient Management~     Strategies (IOMS) versus Routine Care (RC) on the outcomes of patients with Rheumatoid~     Arthritis (RA) that are treated with adalimumab.~      This is a multi-center, randomized, controlled, parallel group, single (patient) blind trial.~     A total of 300 patients (100 per group) with RA will be recruited from approximately 40 sites~     across Canada.~   "
151374|NCT01585051|"~     The effect of administration of vitamin D is tested on the long-term control of blood sugar~     (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood~     pressure profiles)in patients with stable type 2 diabetes mellitus~   "
151375|NCT01585038|"~     The purpose of this study is to compare the cardiovascular profiles of efavirenz and~     rilpivirine, which are two drugs used to treat HIV infection.~   "
151421|NCT01584440|"~     The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923~     compared to placebo, for the treatment of symptoms of agitation in patients with Alzheimer's~     Disease (AD).~   "
151695|NCT01580800|"~     The purpose of the National Breast Cancer Lymphedema Registry is to collect health~     information in order to study the lymphedema as a complication of breast cancer treatment.~     The investigators hope to learn whether early diagnosis will help to prevent lymphedema or,~     if it does occur, to reduce the severity.~   "
151376|NCT01585025|"~     The investigators propose to develop studies of obeticholic acid (OCA) in patients with bile~     acid diarrhoea. OCA is a semisynthetic bile acid, also known as 6αethylchenodeoxycholic acid~     or INT747,and is a potent farnesoid X receptor (FXR) agonist. Preliminary data suggests that~     patients with bile acid diarrhoea have impaired production of the ileal hormone Fibroblast~     Growth Factor 19 (FGF19). FGF19 is stimulated by FXR agonists, and regulates bile acid~     synthesis. This study is a pilot, proof-of-concept, open-label study to investigate whether~     OCA can stimulate FGF19 in bile acid diarrhoea patients to provide a safe and effective~     treatment.~   "
151377|NCT01585012|"~     This is a human factors usability study designed to validated usability by obtaining feedback~     in a home use environment regarding ease of use of the Focus Touch™ Conception System~     Conceptacle (when used to collect semen) and the instructions for use. The investigators will~     collect data to demonstrate that the usability requirements of the conception system as~     collection device, as determined by Usability Specification: Focus Touch Conception System,~     ER-000001 have been met. The ability of the device to be used during sexual intercourse~     without discomfort or injury to the female participant's vaginal/cervical tissues shall also~     be taken into account. Participating couples will be asked to use the Focus Touch™ Conception~     System Conceptacle (in condom form), using the Instructions For Use, to collect semen during~     sexual intercourse in a home use environment. This study will involve sexual intercourse~     between monogamous, heterosexual couples who are trying to conceive or are on a non-vaginal~     birth control with which they do not normally use condoms. Participants will be asked to~     complete the study and the questionnaire within 3 days of receiving the study packet. Contact~     information shall be collected, but participants will only be contacted if they fail to~     return the questionnaire within the requested timeframe.~   "
151378|NCT01584999|"~     Aim of the study is to evaluate the effects, on microcirculation of septic patient, of three~     types of RBCs: 1- fresh standard RBCs (storage <10 days); 2-leukodepleted RBCs and 3-old~     standard RBCs (storage >15 days) respectively. Before and 1 hour after the transfusion,~     microcirculation is evaluated using Sidestream Dark Field Imaging (SDF) and Near InfraRed~     Spectroscopy (NIRS) with vascular occlusion test. We also monitor temperature, heart rate,~     mean blood pressure, hemochrome, blood gases, blood lactates and SOFA score.~   "
151379|NCT01584986|"~     Regeneration of the occluded peripheral arteries by autologous stem cell therapy is an~     emerging treatment modality for no-option patients with peripheral artery disease (PAD). The~     purpose of this study was to assess safety and efficacy of ex vivo expanded, peripheral~     blood-derived, autologous angiogenic cell precursors (ACPs) in no-option PAD patients.~   "
151380|NCT01584973|"~     Stair negotiation is an important activity of daily living. Patients with cruciate ligament~     injury may have difficulty in stair negotiation because of the proprioception deficit and~     neuromuscular deficit caused by ligament injury. However, the influence of knee cruciate~     ligament injury on the control of movement is still unclear. Since inter-joint coordination~     can provide the information of relationship between angle position and angle velocity, it may~     be useful to analysis the change of movement pattern.This current study aimed to investigate~     the change of inter-joint coordination and muscle activation in patients with cruciate~     ligament injury during stair negotiation.~   "
151381|NCT01584960|"~     The aim of the present study is to investigate the effect of endurance on PSA doubling time~     in prostate cancer patients with an elevation in PSA following radical prostatectomy for~     localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory~     markers and improvement in insulin sensitivity and body composition are investigated.~   "
151382|NCT01584947|"~     The aim of the project is to do a fase two trial, where the effect of a local anesthetic~     lozenge will be tested in regard to oral pain, dryness of the mouth, irregularity of taste as~     well as investigate a potential antiinflammatory effect in patients with burning mouth~     syndrome, Sjögrens syndrome and lichen planus.~   "
151383|NCT01584934|"~     Chronic fatigue syndrome (CFS) is a disabling, unexplained disorder characterized by physical~     and mental exhaustion. Complaints of disturbed and unrefreshing sleep are very common in CFS~     patients, however, the relationship between (disturbed) sleep quality and fatigue is still~     not fully elucidated. To evaluate the effect of sodium oxybate on fatigue and to explore the~     interdependence of sleep quality and fatigue in CFS, a double blind, randomized, placebo~     controlled cross-over trial with sodium oxybate is carried out in CFS patients.~      The aim of this study is to address the issue of the effect of sodium oxybate on fatigue as a~     presenting symptom in chronic fatigue (CF) and CFS patients, in the absence of underlying~     medical or psychiatric illness. The answer to this question may shed further light on the~     enigmatic relationship between sleep and fatigue. We also want to investigate the effect of~     sodium oxybate on sleepiness and general health in the same target population.~      Zero-hypothesis: there is no effect.~   "
151384|NCT01584921|"~     Erythropoietin (EPO) is a glycoprotein produced mainly in the kidney. After its release to~     the bloodstream EPO binds to its receptor predominantly located within the bone marrow where~     erythropoiesis is stimulated. Recently, we have shown that recombinant human EPO (rHuEPO)~     down-regulates circulating levels of renin and aldosterone. Concomitant clearance studies~     revealed a decrease in proximal tubular reabsorption of sodium and water and a fall in~     glomerular filtration rate (GFR). These results for the first time demonstrate a link between~     EPO and renal function: By inhibiting proximal tubular reabsorption, which in turn results in~     rapid declines in GFR and renin/aldosterone levels, EPO may directly reduce the major oxygen~     consuming factor in the kidney. The expected result will be an increase of the oxygen tension~     in the environment of renal EPO producing cells, in this way initiating an appropriate signal~     for down-regulation of endogenous EPO synthesis when circulating levels of EPO are high.~      The aim of this project is to test this hypothesis by investigating the renal effects of~     rHuEPO in humans. In a double-blinded manner healthy subjects will be tested with placebo, or~     low-dose rHuEPO for two weeks, or high-dose rHuEPO for three days. Accurate sodium balance~     studies will be conducted together with renal clearance studies for measurements of renal~     plasma flow (131I-Hippuran clearance with renal venous sampling), GFR (51Cr-EDTA clearance)~     and the segmentel tubular handling of sodium and water (lithium clearance).~      EPO is the sole haematopoietic growth factor that is mainly produced in the kidneys and the~     project will provide new information about basic physiological issues regarding the~     association between renal function and the regulation of EPO synthesis.~   "
151385|NCT01584908|"~     Influenza is an important public health problem. Organ transplant patients are particularly~     susceptible to severe disease. Also, they shed higher quantities of virus for longer~     durations, leading to greater contagious potential, thereby potentially serving as nodes of~     spread in the community. Therefore, improved strategies to prevent influenza in this~     population is an important public health concern. Standard vaccination is poorly immunogenic~     post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules~     that create a strong local inflammatory response and they attract immune cells to the site of~     injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza~     vaccines containing adjuvants have become available in Canada but have only limited~     information in transplant patients. This randomized trial is designed to assess the~     immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for~     seasonal influenza in a cohort of adult organ transplant recipients.~   "
151386|NCT01584895|"~     Cardiac rehabilitation programs improve mortality, functional capacity, and quality of life,~     for a variety of patients with heart disease. It stands to reason that patients with LVADs~     might therefore also benefit from the same structured exercise training, education, and~     clinical surveillance. One potential benefit of cardiac rehabilitation in this patient~     population is reversal of the skeletal muscle atrophy that occurs due to extended periods of~     poor peripheral perfusion (i.e. before implantation) and prolonged sedentary behavior.~      Purpose: The purpose of this proposed study is to examine the effects of a 6-week exercise~     program on cardiorespiratory fitness, quality of life, and device flow rate in patients with~     recently implanted LVADs.~      Methods: 30 patients with recently implanted LVADs will be referred by the Henry Ford~     Hospital Advanced Heart Failure Program once the patient is deemed appropriate for exercise.~     Before enrollment into cardiac rehabilitation patients will undergo a six minute walk test~     and graded exercise stress test on a treadmill to determine exercise capacity. Additionally,~     a quality of life questionnaire will be given.~      Following the stress test, patients will be randomized (2 to 1 ratio) into either cardiac~     rehabilitation or control. Those chosen to be in the control group will be encouraged to~     maintain daily activities; those in the rehabilitation group will partake in 6 weeks of a~     standard cardiac rehabilitation program. This will consist of 3 days a week of supervised~     exercise as well as education regarding diet and lifestyle modifications.~      At 6 weeks after randomization both groups will again undergo fitness assessments and retake~     the quality of life questionnaires.~   "
151387|NCT01584882|"~     Electronic dental records (EDR) are a potentially powerful tool to incorporate current~     scientific evidence into clinical practice by providing key information at the point of~     patient care. The investigators know that disseminating evidence-based guidelines is not~     sufficient to change clinical practice so innovative approaches need to be tested in~     dentistry. The composite expertise of the investigators and consultants on this project and a~     large group practice with multiple clinics utilizing one EDR are essential to address the~     aims of this study. This project will examine whether dentists and hygienists will assess~     interest in quitting and deliver a tobacco intervention more frequently when provided with~     computer assisted guidance compared to a control group. Specifically the investigators will~     measure the delivery of questions assessing willingness to change and appropriate~     interventions based on willingness to change by measuring the recording of these activities~     in the EDR and patient receipt of these recommendations through a phone survey. In addition,~     the study will do a qualitative assessment of the patient perceived value of the~     provider-patient encounter to further inform us about patient perception of this interaction.~     The investigators want to know if dental providers will utilize these tools during the dental~     encounter. If they are used, the investigators would propose further studies examining~     smoking cessation rates. The investigators were not able to measure cessation rates due to~     the short two year timeline of this funding mechanism. This tool has potential application~     for other clinical topics, which makes this approach very innovative when considering the~     translation of evidence into the unique clinical practice of dentistry.~   "
151388|NCT01584869|"~     Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe~     GI-Bleeding.~   "
151389|NCT01584856|"~     It is known that small dense LDL particles are associated with an increased cardiovascular~     risk. LDL particles can be separated by gradient gel electrophoresis (GGE) according to their~     size. The risk to suffer from coronary heart disease is 3-7 fold elevated in subjects with~     small dense LDL particles compared to subjects with large LDL particles. This study aims at~     evaluating the predictive value of small dense LDL particles in patients with prediabetes and~     type 2 diabetes mellitus concerning future changes in intima media thickness, flow-mediated~     dilation and other risk factors of atherosclerosis (e.g. insulin resistance). 60 patients~     with prediabetes or type 2 diabetes will be recruited for the study. Assessment will include~     medical history (risk factors), physical examination (blood pressure, BMI, waist-to-hip~     ratio), collection of serum, oral glucose tolerance test, measurement of intima media~     thickness and endothelial dysfunction by ultrasound. All measurements will be repeated after~     2 years. Data will be analysed to assess whether the amount of small dense LDL particles can~     predict further structural and functional changes of the cardiovascular system or changes in~     the severity of the disease (insulin resistance).~   "
151390|NCT01584843|"~     Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820~     compared with non-treatment in patients with strabismus based on angles of strabismus in the~     primary position.~   "
151391|NCT01584830|"~     The purpose of this study is to assess if Regorafenib in combination with best supportive~     care will slow down tumor progression and result in increased survival in patients with~     metastatic colorectal cancer.~   "
151392|NCT01584817|"~     Cell phone retell the instruction of bowel preparation on the day before colonoscopy would~     help patient to prepare for colonoscopy and improve the quality of the bowel preparation.~   "
151393|NCT01584804|"~     This study aims to observe the therapeutic effect of Su-Huang antitussive capsule on cough~     variant asthma.~      The investigators hypothesize:~      Cough score and cough reflex sensitivity will be improved after treatment with Su-Huang~     antitussive capsule.~   "
151394|NCT01584791|"~     The aim of the current study is to compare the antiplatelet efficacy and safety of~     clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients~     after coronary stent implantation.~   "
151396|NCT01584765|"~     Drug re-administration or rechallenge should be avoided after drug-induced liver injury~     (DILI) to avoid recurrent and fatal injury. Rechallenge outcomes vary considerably by drug~     and patient subjects. In order to better predict these outcomes, the objective of this~     analysis is to assess clinical outcomes of positive drug rechallenge following possible~     drug-induced liver injury. Electronic medical records from Kaiser Permanente California~     (KPSC), a managed care organization, will be utilized to identify patients who experience~     possible drug-induced liver injury following exposure to medications associated with~     hepatotoxicity, and who are then rechallenged with the medication.~   "
151397|NCT01584752|"~     This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high~     transsphincteric fistulas. Follow-up time is six months~   "
151398|NCT01584739|"~     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics~     of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation~     of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given~     once daily.~   "
151399|NCT01584726|"~     The purpose of this study is to investigate the use of magnesium sulfate nebulization in~     patient with moderate to severe asthma exacerbation in pediatric emergency.~   "
151400|NCT01584713|"~     The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the~     treatment of enterocutaneous fistula.~   "
151401|NCT01584700|"~     Heart failure is a common condition with debilitating symptoms and a poor prognosis. Patients~     with heart failure have a massively overactive sympathetic nervous system which attempts to~     compensate for their poorly functioning heart. This ultimately has only detrimental effects.~      One of the principle mediators for this sympathetic response is found in the nerve cells in~     the kidneys. Whilst a significant proportion of medications used to treat heart failure act~     on these harmful pathways, none target the kidney sympathetic-nerve cells specifically.~     Additionally, because of their multiple sites of action these drugs all have side effects.~      A new procedure that has recently been developed for the treatment of high blood pressure is~     renal denervation. This involves inserting a small catheter through the femoral artery and~     passing it to the kidney artery under x-ray guidance. From there, using radiofrequency waves,~     the sympathetic nerves within the kidney can be destroyed.~      The investigators anticipate that this procedure will have a significant positive effect on~     patients with heart failure and aim to perform a pilot safety study on 7 individuals with~     advanced heart failure to assess its safety and effectiveness. The investigators hypothesise~     that renal artery denervation will lead to significant clinical and biochemical improvements~     in patients with marked heart failure.~   "
151402|NCT01584687|"~     Objectives: 1. Determine if mRNA expression could be use as a biomarker to predict and~     monitor the response to omalizumab in patients with difficult control asthma 2. Identify~     which genes are switched on and which are switched off by using Omalizumab.~      Methods: This study is an open label clinical trial, with six patients. The patients will~     receive Omalizumab according to their age and weight (maximum dose: 375 mg every 15 days) for~     4 months. There will be a run-in period of one month, when allergic asthma diagnosis will be~     confirmed and treatment will be optimized. Patients will be evaluated and will have blood~     sample collected on 3 occasions: in the beginning, 2 months after baseline and at the end of~     the study. Blood samples will always be collected one week after the last omalizumab dose.~     Primary outcome will be RNA expression of 20 genes measured by real time-PCR (high-affinity~     IgE receptor, IL-4, IL-5, IL-13, gama-IFN, quimokines, Fc epsilon, between others). Secondary~     outcomes will be ACT, ACQ and spirometry.~   "
151403|NCT01584674|"~     The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic~     System in patients with moderate to severe facial acne vulgaris using a split-face design~     (treated hemiface vs untreated hemiface).~   "
151404|NCT01584661|"~     Objectives:~        1. To determine the level of compliance with nutritional recommendations (dietary and~          nutritional supplements) following discharge from hospitalization;~        2. To identify barriers for post-discharge adherence to professional nutritional~          recommendations;~        3. To determine the impact of adherence (high vs. low) to the nutritional treatment~          guidelines on functional and health indicators.~      Working hypothesis:~      High adherence to nutritional care after hospitalization will be associated with better~     functional and health outcomes.~   "
151405|NCT01584648|"~     This is a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib~     (GSK2118436) and trametinib (GSK1120212) combination therapy to dabrafenib administered with~     a trametinib placebo (dabrafenib monotherapy). Subjects with histologically confirmed~     cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K~     mutation positive will be screened for eligibility. Subjects who have had prior systemic~     anti-cancer treatment in the advanced or metastatic setting will not be eligible although~     prior systemic treatment in the adjuvant setting will be allowed. Approximately 340 subjects~     will be randomized 1:1 (combination therapy: dabrafenib monotherapy). Subjects will be~     stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus~     less than or equal to the ULN) and BRAF mutation (V600E versus V600K). The primary endpoint~     is investigator-assessed, progression-free survival for subjects receiving the combination~     therapy compared with those receiving dabrafenib monotherapy. Subjects will be followed for~     overall survival; crossover will not be permitted.~   "
151406|NCT01584635|"~     Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less~     invasive treatment for Achalasia has been developed.~      The purpose of this study is to decide the role this less invasive treatment (Peroral~     Endoscopic Myotomy) has in the treatment of patient's with achalasia.~   "
151407|NCT01584622|"~     The purpose of the study is to evaluate the effectiveness of the CADence system, a~     non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in~     the coronary tree.~   "
151472|NCT01583725|"~     The investigators are looking at the differences in appetite and obesity between weight loss~     participants and patients undergoing bariatric surgery.~      Obese persons between the ages of 18 & 65 are eligible to participate in this study, whether~     or not they intend to undergo bariatric surgery.~   "
151788|NCT01579565|"~     The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302~     (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain~     in individuals undergoing Intraocular Lens Replacement (ILR) surgery.~   "
151408|NCT01584609|"~     This is a prospective, randomized, single blind, concurrent controlled, multi-center study.~     Patients presenting with symptoms of acute ischemic stroke who have evidence of a large~     vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned~     to either the Penumbra System with the Separator 3D or the Penumbra System without the~     Separator 3D. Each treated patient will be followed and assessed for 3 months after~     randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute~     ischemic stroke in vessels accessible to the Penumbra Separator 3D System for~     revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the~     safety and effectiveness of the Penumbra System with the Separator 3D for the~     revascularization of large vessel occlusion is not inferior to the Penumbra System alone.~   "
151409|NCT01584596|"~     The Lower Mississippi Delta (LMD) population is characterized by high levels of overweight~     and obesity, which are the result of long-term disruptions in energy imbalance where dietary~     energy intake has exceeded energy expenditure associated with physical activity. To address~     this issue, the overall goal of this project is to determine ways in which the U.S.~     Department of Health and Human Services and U.S. Department of Agriculture Dietary Guidelines~     for Americans (2005) physical activity recommendations can be effectively adapted for the LMD~     population. Phase I of this study was completed in early 2011.~   "
151410|NCT01584583|"~     The purpose of this study is to monitor the blood pressure level of the patient using a~     preformed cuff ranged 22 cm-36 cm.~   "
151411|NCT01584570|"~     The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation~     on heart rate variability and QTc interval.~   "
151412|NCT01584557|"~     The purpose of this study is to evaluate the short term efficacy and safety of tolvaptan in~     subjects hospitalized for worsening heart failure who have volume overload and one of the~     following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy.~     The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8~     and 16 hours.~   "
151413|NCT01584544|"~     This phase I study is designed to determine the maximum tolerant dose of capecitabine when~     used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75~     years old.~   "
151414|NCT01584531|"~     The primary objectives of this study are to determine if rigosertib sodium, given orally in~     the form of soft gel capsules, is safe and is associated with a reduction in the number of~     blood transfusion units that are needed in patients with myelodysplastic syndrome (MDS)~     classified as Low or Intermediate-1 (Int-1) (any cytogenetics) or trisomy 8 Intermediate 2~     (Int-2) in the International Prognostic Scoring System (IPSS) who are transfusion-dependent.~     Rigosertib will be taken on days 1 to 21 of a 21-day cycle.~   "
151415|NCT01584518|"~     The long-range goal of this proposal is to decrease morbidity and mortality related to~     pulmonary edema and congestive heart failure (CHF) in post-operative patients. The~     short-range goal is to determine a mechanistic endpoint when therapy for impending heart~     failure can be initiated and terminated based on B-type natriuretic peptide (BNP) levels. The~     investigators propose to utilize changing levels of BNP as a surrogate marker for CHF.~   "
151416|NCT01584505|"~     Cardiac Safety Study~   "
151417|NCT01584492|"~     The purpose of this clinical study is to compare the improvement in breathing of single~     administration of CHF 1535 50/6 pMDI (fixed combination of a corticosteroid drug~     beclomethasone 50 µg + formoterol 6 µg/puff, 2 inhalations, total dose 100/12 µg) given with~     spacer versus free combination of beclomethasone 50 µg/puff pMDI (2 inhalations, total dose~     100 µg) given with spacer plus formoterol 6 µg/puff pMDI (2 inhalations, total dose 12 µg)~     given with spacer in terms of FEV1 from 0 to 12 hours in asthmatic children.~      Additionally the study aims to evaluate the effects of doses of CHF 1535 pMDI compared to~     placebo and the effect on other lung function parameters, to assess the safety and~     tolerability of CHF 1535 dosages in children.~   "
151418|NCT01584479|"~     This study is one component of a program to improve the maintenance of good dental health and~     the prevention of disease by use of risk stratification methods to efficiently guide~     increased preventive services to adult dental patients who are at increased risk for the~     major dental diseases, caries and adult periodontitis.~      The investigators will use a retrospective cohort model to analyze a large dental claims~     database to determine if the frequency of preventive services influenced the periodontal~     disease outcomes and to determine if periodontal risk assessment information can be used to~     stratify dental patients into high risk and low risk categories that influence the effect~     of preventive services on periodontitis outcomes.~      Primary Objective To evaluate whether dental patients who are classified as low risk for~     periodontal disease progression, based on history of periodontitis (claims history), smoking,~     diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they~     had two dental cleanings per year compared to one cleaning per year.~      Secondary Objectives To evaluate whether dental patients who are classified as high risk~     for periodontal disease progression, based on a history of periodontitis, smoking, diabetes,~     and IL-1 genetic variations, have different primary and secondary endpoints if they had two~     dental cleanings per year compared to one cleaning per year.~      To evaluate whether dental patients who have had one dental cleaning per year have different~     primary and secondary endpoints if they are classified as low risk for periodontal disease~     compared to patients who are classified as high risk. To evaluate whether dental patients~     who have had two dental cleaning per year have different primary and secondary endpoints if~     they are classified as low risk for periodontal disease compared to patients who are~     classified as high risk.~   "
151419|NCT01584466|"~     Comorbid substance abuse leads to many deleterious effects such as medical comorbidities and~     nonadherence, which is one of the most problematic issues. People with schizophrenia and~     substance use disorders (SUDs) are at an increased risk nonadherence compared to those who do~     not use alcohol and illicit drugs. The investigators propose that this new marketed~     injectable antipsychotic with many benefits over other available long acting injectable~     agents would be beneficial in the dually diagnosed population and may represent a specific~     schizophrenia subpopulation where long acting agents may be considered an important~     therapeutic option.~   "
151420|NCT01584453|"~     Despite advances in the treatment of heart attacks the complications and death rates from~     failure of the heart to pump properly after treatment remain high. A heart attack occurs when~     one or more of the arteries that supply blood to the heart become blocked, causing the heart~     to be starved of oxygen and nutrients. This results in damage to the heart and so the the~     heart pumps less well. The main treatment for a heart attack is balloon treatment to open the~     blocked artery (called primary angioplasty). Whilst re-opening the artery is essential and~     allows blood to flow to the area of the heart starved of oxygen, this process also causes~     damage itself (called reperfusion injury) and increases the size of the heart attack further.~     Currently there are no treatments available that reduce this reperfusion injury. The~     investigators and others have shown that a substance called sodium nitrite reduces~     reperfusion injury in experimental models of a heart attack. The aim of this research is to~     perform a trial to investigate whether during a heart attack, an infusion of sodium nitrite~     into the damaged artery protects against reperfusion injury and reduces heart attack size in~     patients.~   "
176990|NCT01248481|"~     To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life~     treatment conditions in a large sample of Korean patients.~   "
151422|NCT01584427|"~     Background Life style related disease is an increasing problem all over the world. The~     Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, high blood~     lipids, high blood pressure and slightly elevated blood sugar. Subjects with MetS have high~     risk of developing Type 2 Diabetes and cardiovascular disease.~      Dietary fibers have been shown to have positive effects on the components of MetS. The~     investigators have special interest in the combination of two types of fiber (Resistant (RS)~     starch and Arabinoxylans (AX)) .~      Hypotheses Increase of RS and AX in the dietary composition has a positive effects on~     components of MetS i.e. decreases blood lipids, improves blood sugar, blood pressure and~     markers of inflammation.~      The subjects undergo two dietary interventions of 4 weeks duration each: A Healthy~     Carbohydrate Diet with a high content of RS and AX is compared to a Western Style Diet~     with a low content of RS and AX.~   "
151423|NCT01584414|"~     Zetiq has introduced a histochemical stain that claims to tinctorially identify cancer and~     neoplastic cells. Because of the potential importance of such a capability, the investigators~     undertook to investigate Zetiq's CellDetect® staining technology as applied to cultured cell~     lines as well as an initial sample of clinical cases. This goal was pursued by investigating~     four types of comparisons: 1) cancer cell lines before and after differentiation; 2) cervical~     squamous-cell carcinoma (SCC) biopsies to non-neoplastic squamous epithelium; 3) SCCs to~     neoplastic, nonmalignant squamous epithelium; and 4) neoplastic squamous cells to~     non-neoplastic squamous cells in cytological preparations. The clinical material was also~     stained with hematoxylin and eosin (biopsies) or Pap (cytologies) for diagnostic purposes.~     The investigators found that all CellDetect®-stained cells exhibited one of the two~     tinctorial outcomes. Cell lines with malignant phenotype uniformly had red/purple cytoplasm,~     whereas the differentiated phenotype changed the color to blue/green.~   "
151424|NCT01584401|"~     Main study objectives:~        1. To compare the temperature measured using Medisim's thermometers to the temperature~          measured using mercury or equivalent reference thermometers.~        2. To develop more accurate algorithms for measuring on the forehead as well as behind the~          ear.~        3. To test the difference between various forehead measurement locations in order to allow~          more convenient measuring that is not depended on the exact location.~   "
151425|NCT01584388|"~     The primary objective of this study is to evaluate the safety and effectiveness of rituximab~     in IgG4-RD.~   "
151426|NCT01584375|"~     Intraventricular hemorrhage (IVH) in preterm infants is one of many devastating consequences~     of prematurity that have both acute and long-term sequelae. Turning a preterm infant's head~     to one side may increase intracranial pressure and occlude major ipsilateral veins in the~     neck, which could increase cerebral venous pressure and decrease cerebral venous drainage.~     Keeping preterm infants' heads in a slightly elevated midline position (side or supine)~     during the first 168 hours(HOL) has been recommended as one of the 10 potentially better~     practices to reduce the incidence of IVH in preterm infants. To the best of our knowledge,~     there has been no systematically collected clinical data quantifying the relationship between~     IVH and head position in preterm infants. However, the midline head position may challenge~     the well-known right neonatal head position preference. This preference continues until 3-6~     months of age, after which preterm neonates keep their heads mainly in midline. The best head~     position for preterm neonates is still to be determined. Therefore, the investigators are~     aiming to conduct a large scale multicenter randomized control trial on order to answer the~     following research question: Does keeping heads of preterm infants less than 30 weeks of~     gestation in flat midline (FM) throughout the first 168 HOL reduce the risk of IVH compared~     to right flat lateral (rFL)? We hypothesized that keeping heads of preterm infants less than~     30 weeks of gestation in FM throughout the first 168 HOL would reduce the risk of IVH~     compared to rFL.~   "
151427|NCT01584362|"~     This research is being done to learn about the safety in humans of a medicine that is already~     used in cows and pigs to treat worms. The medicine may be useful for people who have these or~     other worms. The medicine will be studied first in healthy people, who will be given a very~     small amount of the medicine once. If the smallest amount of medicine is found to be safe, a~     slightly higher amount will be given to a new group of volunteers. The highest amount that~     will be tested is similar to the amount given to animals. If the medicine can be given safely~     to healthy people in the planned amounts, a later study will be done in people who have worms~     to see if the medicine kills the worms.~   "
151428|NCT01584336|"~     The purpose of this study is to evaluate the safety and feasibility of laparoscopy-assisted~     total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This~     study will performed via prospective, multicenter design.~   "
151429|NCT01584323|"~     In this study the investigators sought to determine the effects of Pomegranate (Natural~     pomegranate polyphenol (P. granatum L) extract) :~        1. On the maternal and fetal oxidative stress and inflammation associated with PPROM.~        2. On the time interval from PPROM to delivery and on fetal Ph and apger score.~   "
151430|NCT01584310|"~     Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss~     or insufficient weight gain, is related to an increase in morbidity and mortality and exposes~     the child to medical complications. In addition, obesity is also related to complications~     during hospitalization and complications in general, and therefore early identification of~     these children is extremely important. Studies show that malnutrition is frequent among~     children upon hospitalization, where the risk of pediatric nutritional deterioration~     increases, even in the presence of mild stress factors. This risk is frequent mainly among~     children that arrive at the hospital with an initial poor nutritional status. Improving the~     nutritional status as part of the standard of care already at the ambulatory setting might~     improve the prognosis of children when ill. In Israel, nutritional screening in not conducted~     among children since there is no proper validated screening tool. Study objectives: To test~     the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to~     be used by nurses, and to compare it to a complete nutritional assessment conducted by a~     dietician in Clalit Health Care Services clinics. In addition, the investigators wish to~     examine the effects of using a screening tool for nutritional risk on the medical staff's~     attention to the nutritional status; this is measured by the collection of nutritional~     status-related data and their recording in the patient file.~      Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric~     Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3~     questions with a summary score, according to which the nutritional risk level shall be~     determined. These children shall also undergo a complete dietician assessment in order to~     examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the~     beginning of the research and after 6 months in order to estimate the change in medical~     staff's attention to nutritional status, by way of noting relevant diagnoses, reference to~     nutritional status- related tests and recording of anthropometric measurements.~      A statistical analysis to examine the validity of the STAMP Tool shall be carried out using~     the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi~     square test.~   "
151483|NCT01583582|"~     The purpose of this proof of concept study is to find out the efficacy of Marealis Refined~     Peptide Concentrate (RPC) from Coldwater Shrimp (Pandalus borealis) containing ACE-inhibiting~     peptides on blood pressure in subjects with mild or moderate hypertension.~   "
151431|NCT01584297|"~     Our proposal is to conduct an open phase II clinical trial that allows us to explore the~     activity of ketoconazole, an inhibitor of the enzyme CYP17, in ovarian granulosa tumors~     similar to what has been done in prostate cancer. The rational is based on dysregulation that~     FOXL2 mutations present in almost all granulosa tumors result in the expression of CYP17 that~     appears to be key in the development and progression of the disease.~      This work would represent the first attempt to address the treatment of ovarian granulosa~     cancer with a molecular solid rational, drawing on the recent identification of the mutation~     leader of this tumor. If succeed provide a widely available therapeutic alternative~     compared with current cancer therapies, with low toxicity. In addition it would open a new~     line of research with CYP17 enzyme inhibitors that could alter the course and outcome,~     usually fatal, in advanced stages of disease.~   "
151432|NCT01584284|"~     The purpose of this study is to determine the safety and tolerability of GL-ONC1 administered~     intravenously in combination with radiation therapy and cisplatin (CDDP)in patients with~     locoregionally advanced head and neck cancer.~   "
151433|NCT01584271|"~     Phase II 3 arm double blinded clinical study, to evaluate pain killing and healing time of~     Botanical Ear Drops, Ear Comfort™, in Severe External Ear Infection (AOE) patients in~     comparison to Dex-Otic® and Otidin®.~      Study Outcome (hypothesis): if Ear Comfort™ proves to perform as well as Dex-Otic, then ENT's~     and family doctors will have a botanical non-antibiotic product that does not promote the~     formation of antibiotic-resistant infections and may be given to anti-biotics sensitive~     patients.~      Ear comfort™ is pharmacologically stable for at least 3 years on the shelves.~   "
151434|NCT01584258|"~     This study is an international multicentre randomised study of organ confined low and~     intermediate risk prostate cancer and is composed of two parallel randomisation schemes based~     on applicability of surgery as a treatment for the patient. Patients for whom surgery is a~     consideration are randomised to either laparoscopic prostatectomy or prostate SBRT. Patients~     for whom surgery is not a consideration are randomised to either conventionally fractionated~     radiation therapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be~     compared across the pairs in each randomisation.~   "
151435|NCT01584245|"~     This clinical trial will evaluate the efficacy of an amino acid formula in infants with~     allergic manifestations.~   "
151436|NCT01584232|"~     The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265~     (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic~     medication (OAM).~   "
151437|NCT01584219|"~     Immature myeloid cells (IMCs) that are generated in the bone marrow, and differentiate into~     mature granulocytes, macrophages and dendritic cells (DCs) in the steady state. Recently, it~     was demonstrated that the IMC population expands in malignancy, both in animal models and in~     humans. These cells were described as immunosuppressants but have also been shown to promote~     tumor angiogenesis. Accordingly, IMCs were also found to take part in the burn injury wound~     healing process and other pathologies that involve angiogenesis. It was shown in the~     investigators' laboratory, that a very similar population of IMCs populates the mouse and~     human placenta, and that these cells actively promote angiogenesis.~      Dendritic cells (DCs) that can differentiate from IMCs, are antigen presenting cells (APCs)~     that initiate and coordinate the innate and adaptive immune responses. DCs can take up a~     diverse array of antigens and present them to T cells as peptides bound to MHC products.~     These antigen-specific responses are critical for resistance to infection and tumors.~     Conversely, DCs have roles in autoimmunity, transplant rejection and immunological tolerance.~     In the reproductive system, DCs were shown to account for 5%-10% of all hematopoietic cells~     in the uterine decidua at the embryonic implantation site. They were shown to promote~     angiogenesis during early pregnancy, especially during implantation. Very little is known~     about their function in the placenta and in the latter part of pregnancy when significant~     angiogenesis takes part.~      The investigators' preliminary mouse experiments and human data, demonstrate a shift in~     IMC/DC populations with the development of the placenta. The investigators hypothesize that~     this population shift may contribute to the labor and delivery process.~      The investigators' aim is to understand the role of these myeloid cell populations during~     pregnancy, to characterize their phenotype and try to shed light on the cellular and~     molecular mechanisms of pregnancy complications, such as preeclampsia, pre-term labor,~     intrauterine growth restriction, etc.~   "
151438|NCT01584206|"~     Ezetimibe has become the treatment choice for patients with sitosterolemia. Ezetimibe is an~     inhibitor of cholesterol absorption from the gastrointestinal tract. The purpose of this~     study is to determine if ezetimibe improves whole body plant sterol and cholesterol~     homeostasis.~   "
151439|NCT01584193|"~     The purpose of this study is to compare two different surgical techniques for implementation~     of totally implantable central venous access ports. Ultrasound-guided suclavian vein puncture~     is compared to cephalic vein dissection.~   "
151440|NCT01584180|"~     Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac~     arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling~     associated cerebrovascular disease. The narrow-time-frame is a major issue (time is brain).~     To provide immediate cooling without delay, easy to use, mobile and effective methods are~     needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Brain.Pad~     (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling~     system. A comparison of these two induction methods has never been done before. Neither was~     the effect of the EMCOOLS Brain.Pad on brain-temperature measured. For the first time iCOOL 3~     compares feasibility, safety and efficacy of the two methods.~   "
151441|NCT01584167|"~     Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac~     arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling~     associated cerebrovascular disease. The narrow-time-frame is a major issue (time is brain).~     To provide immediate cooling without delay, easy to use, mobile and effective methods are~     needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Flex.Pads~     (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling~     system. A comparison of these two induction methods has never been done before. Neither was~     the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the first time iCOOL 2~     compares feasibility, safety and efficacy of the two methods.~   "
151442|NCT01584154|"~     The purpose of this study is to compare the safety and effectiveness of cryoablation and~     radiofrequency ablation in the treatment of the commonest kind of supraventricular~     tachycardia, namely atrioventricular nodal reentrant tachycardia. The study hypothesis is~     that cryoablation is non-inferior to radiofrequency.~   "
151504|NCT01583309|"~     Convective therapies have been proposed for improving chronic dialysis patient outcomes,~     including intradialytic symptomatic hypotension.~      To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different~     types and doses of convective therapies compared with low-flux hemodialysis (HD), the~     investigators performed a multicentre, open-label, randomized controlled trial.~   "
151443|NCT01584141|"~     Background:~      - Lymphoma rates in Asia have been lower than in the West, but rates have been rising in~     recent years. Most studies of lymphoma patients have been conducted in the West. Less~     information is available about the factors that might contribute to the rise of lymphoma in~     Asia. Researchers want to collect medical and personal histories and samples from people who~     have recently been diagnosed with lymphoma. This information will help them study possible~     reasons for this increase.~      Objectives:~      - To collect samples and histories as part of an introductory study of lymphoma in Asia.~      Eligibility:~        -  People between 18 and 79 years of age who have entered study hospitals in Hong Kong,~          Taiwan, and mainland China for treatment for any type of lymphoma.~        -  Healthy volunteers between 18 and 79 who have never had lymphoma.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  They will provide blood samples and cheek cell samples for testing.~        -  Participants will complete a questionnaire about their personal health history. They~          will answer questions about exposures to chemicals like pesticides. They will also be~          asked about family medical history and work and residential history. Finally they will~          answer questions about lifestyle factors like diet and exercise.~        -  They will give permission for the researchers to see their medical records. Researchers~          will also have access to any tumor samples collected as part of treatment.~   "
151444|NCT01584128|"~     The goal of the investigators study is to determine whether the use of oxidized regenerated~     cellulose reduces the risk of vaginal cuff cellulitis, pelvic abscess, or vaginal cuff~     dehiscence in patients undergoing laparoscopic hysterectomy. The investigators hypothesize~     that the use of oxidized regenerated cellulose will reduce the risk of vaginal cuff~     cellulitis, pelvic abscess, and vaginal cuff dehiscence in patients undergoing laparoscopic~     hysterectomy.~   "
151445|NCT01584115|"~     This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability,~     immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined~     with the adjuvant MPLA from B. pertussis in cancer patients.~   "
151446|NCT01584102|"~     The intervention included biweekly access to group fitness classes, with (Group 1) or without~     (Group 2) weekly nutrition and physical activity education sessions. Outcome measures were~     assessed at baseline and immediately post intervention and included BMI, waist circumference,~     blood pressure, physical activity and dietary behaviors, and psychosocial variables.~   "
151447|NCT01584076|"~     Amblyopia is the leading cause of monocular visual impairment in children and adults. Despite~     conventional treatment with patching or eye drops, many older children and adults do not~     achieve normal vision in the amblyopic eye.~      Donepezil is an acetylcholinesterase inhibitor that increases levels of the neurotransmitter~     acetylcholine in the brain. Use of acetylcholinesterase inhibitors has been demonstrated by~     the Hensch lab (Department of Neurology, FM Kirby Neurobiology Center) at Boston Children's~     Hospital to improve vision and reverse amblyopia in animal models.~      The purpose of this study is to evaluate the efficacy of oral donepezil as treatment for~     residual amblyopia (20/50 - 20/400) in patients 8 years of age and older.~   "
151448|NCT01584063|"~     Healthy Mothers on the Move (Healthy MOMs), was a prospective randomized controlled trial~     that aimed to demonstrate the effectiveness of a healthy lifestyle intervention to reduce~     risk factors for obesity and type 2 diabetes. This behavioral intervention was tailored to~     the needs of pregnant and postpartum Latino women. This study was conducted between 2004 and~     2006 in southwest Detroit.~   "
151449|NCT01584050|"~     Folic acid, a form of the vitamin folate, is added to grain products in Canada to help reduce~     birth defects. Folic acid is the synthetic form of folate and is very stable (doesn't break~     down) when added to foods. There are emerging health concerns about chronic folic acid~     consumption. Recently another more natural form of folate, L-5-methyltetrahydrofolate~     (L-MTHF) has become available. The investigators plan to conduct a randomized trial in women~     to determine if supplements containing L-MTHF consumed over three months raises blood folate~     levels as much as supplements containing folic acid. The investigators hypothesize that~     L-MTHF will increase red cell folate over 12 weeks to same extent as equimolar folic acid.~   "
151450|NCT01584037|"~     The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect~     data concerning:~        1. Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral,~        2. Potential confounding factors, and~        3. The outcome of these pregnancies.~      The secondary purpose of the Adenovirus Vaccine Pregnancy Registry is to evaluate the~     frequency of birth defects in prospectively enrolled pregnant women. This Registry is also~     designed to detect any unusual patterns of birth defects.~   "
151451|NCT01584024|"~     The purpose of this study is to determine whether lesion infiltration is an effective~     management strategy to arrest early tooth decay.~   "
151452|NCT01584011|"~     Objectives~      To evaluate the impact of taste disturbance in different types of chronic middle ear diseases~     and after middle ear surgery.~      Hypothesis~      That patients with chronic otitis media and cholesteatoma has taste disturbance already~     before surgery due to the disease itself, of course depending on degree of the disease.~      That patients with otosclerosis, has a normal nerve function before surgery.~      That patients with normal taste before surgery are more likely to notices a taste~     disturbance.~      That nerve in continuity after surgery, even if it is maltreated, gives less taste~     disturbance than a divided nerve.~      Methods~      A clinical study has been launched that measures taste function with two different methods~     for taste measurements, electrogustometry (EGM) and the filter paper disc method (FPD) before~     and after middle ear surgery in patients operated with middle ear surgery because of~     otosclerosis, chronic otitis media and cholesteatoma. The investigators plan to include 120~     patients in this study.~      A parallel study of the patients own experience of the symptom has also been launched were~     the patients answer a questionary and a quality of life document. The investigators plan to~     include 300 patients in this study.~      A histological study where specimens of CTN from healthy ears and from ears with chronic~     disease will be investigated with electron microscopy has also started.~   "
151541|NCT01582828|"~     Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the~     surgical (epicardial) approach seems to be the most effective. Still, however a significant~     amount of failures exist which is mostly due to incompleteness of the surgical ablation~     lines. Checking, and if necessary additional ablation, of these lines afterwards~     endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this~     problem.~   "
151453|NCT01583998|"~     The pilot study will evaluate whether electronic-Measurement Based Care (e-MBC) using the UT~     Southwestern MyChart personal health record is feasible, associated with patient and health~     care team satisfaction, and improves treatment outcomes compared to a standard treatment~     model. The project will be conducted in the Simmons Cancer Center Clinic at the University of~     Texas Southwestern Medical Center, Dallas as a collaborative effort between the Departments~     of Psychiatry, Oncology, and Family and Community Medicine. The primary patient population~     will include adults with significant depression and/or starting an antidepressant treatment~     and/or experiencing a treatment change. The study will compare two groups, an e-MBC group and~     an office-based standard care MBC group. Study staff will explain the study to the patients,~     specifically explaining that study participants will receive either office-based MBC or~     e-MBC. Eligible participants must be willing to receive either form of treatment monitoring.~     Participating patients will be randomly assigned to receive either e-MBC or office-based MBC.~     In the e-MBC group once a month the study nurse will send a prompt from the participating~     patients treating physician requesting the patient to use the MyChart system to fill-out the~     MBC scales. Beyond these monthly assessments, patients will be encouraged to utilize the~     MyChart MBC assessments (e-MBC) at any time to communicate with their physician. Patients~     experiencing difficulties using the e-MBC system will be given additional instruction by the~     study nurse. Patients and physicians will be trained in the use of the eMBC system. In the~     office-based MBC group the study nurse will schedule monthly treatment visits and request the~     patient call as needed to report symptoms. The evaluation period will be 6 months.~   "
151454|NCT01583985|"~     Chronic musculoskeletal pain conditions are among the most prevalent conditions in VA primary~     care. Over the past two decades, improved clinical attention to pain has been associated with~     exponentially greater use of long-term opioid therapy for chronic non-cancer pain, both~     within and outside the VA system. Despite this change in practice, the proper place of~     opioids in chronic pain management continues to be controversial because research has not~     demonstrated the long-term safety and effectiveness of opioids for chronic musculoskeletal~     pain. The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) Trial will~     fill a critical gap in the evidence by comparing effectiveness and harms of two clinically~     relevant analgesic prescribing strategies-one that emphasizes early use of strong opioids and~     one that delays and minimizes opioid use-for Veterans with chronic back, hip, or knee pain.~     SPACE is designed to be highly relevant to clinical decision-making in VA primary care and to~     produce knowledge that will improve the lives of Veterans living with chronic pain.~   "
151455|NCT01583972|"~     Vitamin A supplementation at birth may increase survival of infants through one year of age~     by reducing mortality from infectious diseases, though current studies are not conclusive on~     this point. The goal of our study is to determine if supplementation of newborn infants with~     50,000 IU of vitamin A improves aspects of immune function that may be impaired by vitamin A~     deficiency. Our underlying assumption is that supplementation may thus decrease risk of death~     by improving immune function and the ability to survive infections. This project will be~     limited to the examination of the impact of vitamin A on immune function and will not aim to~     determine the impact on morbidity or mortality, which would require larger sample sizes. The~     hypotheses addressed by this study are as follows: Provision of vitamin A supplements to~     newborns at risk of vitamin A deficiency will (1) improve functioning of the thymus (the~     source of T lymphocytes, cells of the immune system that are important in response to~     infection and immunization); (2) enhance T lymphocyte-mediated responses to standard vaccines~     given at birth and early in infancy; and (3) improve gut barrier function (i.e., ability to~     prevent bacterial infection across the epithelial barrier), relative to provision of a~     placebo.~   "
151456|NCT01583959|"~     Introduction: Methotrexate is the sheet anchor for the treatment of rheumatoid arthritis.~     Folic acid supplementation is usually given at a dose of 5-30 mg per week to ameliorate~     adverse effects. Patients at our center are usually on the higher dose. However, it is~     unclear if higher doses are required, recent international recommendations suggest 5-10 mg~     per week only.~      Objectives: To randomize rheumatoid patients being being started on Methotrexate into 2~     groups- one on 5mg for 6 days a week (30mg per week) of folic acid and the other 5 mg twice a~     week (10 mg per week) for 24weeks. To look at difference in~        1. Adverse effects due to methotrexate~           a. Minor adverse effects: By symptom chart~           a. Major adverse effects: Cytopenia (predefined) and transaminitis.~        2. Disease activity using Disease activity score 28 joints (3 variable) and functional~          status by health assessment questionnaire~        3. RBC folic acid levels Methodology: Randomised controlled trial, double blinded, placebo~          controlled. Sample size 50 in each group. One group of patients will receive folic acid~          5 mg twice a week with placebo for 4 days and the other group will receive folic acid 5~          mg 6 days a week for 24 weeks.~      Patients will be administered adverse effects proforma, assessed for having cytopenias and~     transaminitis (pre defined) and disease activity will be calculated at every visit, ie., in~     the beginning at then at 8,16 and 24 weeks. In addition will look at the functional status~     and RBC folate levels at 0 and 24 weeks. Statistical analysis using chi-square test for~     proportions and t test for continuous variables.~   "
151484|NCT01583569|"~     Complex Dynamic Systems in Mood Disorders is an observational, exploratory study of the~     relationship between voice samples, heart rate, respiration, movement, galvanic skin~     conductance, and sleep architecture with mood states in patients with Major Depressive~     Disorder, Bipolar Disorder, and healthy controls. The overall hypothesis is that nonlinear~     dynamic analyses will be able to reveal hidden patterns of complexity in each domain of~     voice, heart rate variability, movement, arousal, and sleep stage data.~   "
151542|NCT01582815|"~     The purpose of this study is to evaluate the efficacy and overall safety and tolerability of~     treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety~     symptoms being treated with an antidepressant.~   "
151668|NCT01581151|"~     This study seeks to compare dexamethasone implant with rescue intravitreal ranibizumab to~     monthly intravitreal ranibizumab for the treatment of macular edema secondary to branch or~     central retinal vein occlusion. This is based on the null hypothesis that dexamethasone~     implant with rescue ranibizumab has inferior best corrected visual acuity at six months~     compared to monthly ranibizumab alone.~   "
151669|NCT01581138|"~     The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in~     subjects who have chronic hepatitis C and have not received treatment yet.~   "
151457|NCT01583946|"~     As individuals age, they undergo transitions in many aspects of their lives. These~     transitions include social, economic and health transitions. People review their lives, and~     reflect on past choices. Future time is limited by the increasing proximity to end of life.~     This may lead to regrets and, in people with the ability to use compensatory mechanisms, a~     redoubling of efforts to achieve valued goals or a reprioritization of valued goals. In the~     context of aging, individuals' past, present, and future-oriented subjective well-being (SWB)~     may change. There is an incomplete understanding of the relationship of SWB, intra- and~     inter-personal resources, and outcomes, (particularly health and healthcare-cost outcomes).~     These issues have complicated the use of SWB measures and the investigators are left with~     traditional metrics such as life expectancy, infant mortality, wealth, and poverty to assess~     healthy aging, resulting in an incomplete picture of healthy aging. This project will examine~     the relationships among SWB, intra- and inter-personal resources, and health and~     healthcare-cost outcomes. It will advance the understanding of SWB and its role in healthy~     aging in order to assist policy makers in valuing the potential benefits of improving SWB on~     health and healthcare costs. The investigators will accomplish this through the following~     specific aim:~      Aim 1: To determine how SWB (past, present, and future-oriented): (1) is affected by life~     transitions, and (2) affects outcomes after life transitions.~   "
151458|NCT01583933|"~     There are several factors involved in the decision and the retention plan, such as occlusion,~     patient age, etiology of malocclusion, the speed of the correction, the length of the cusps~     and health of the tissues involved, relationships inclined planes, size of the arches,~     harmony of the arches, muscle pressure, interdental proximal contact, cell metabolism and~     atmospheric pressure. Given these concepts, we need to find grounds to enable decision making~     with respect to the retainer that offers the best features of containment and stability.~   "
151459|NCT01583920|"~     Radiation therapy is considered a standard treatment option for the management of localized~     prostate cancer. Among the 20-30% who recur, a proportion of them will present with an~     isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as~     a source for subsequent metastases. Salvage options available for isolated local recurrence~     include; temporary or permanent implantation of radioactive seeds into the prostate, complete~     removal of the prostate gland, use of low temperatures to treat the disease, and high~     frequency ultrasound to treat the disease. There are risks of complications associated with~     all these treatments, and there is presently no consensus as to which treatment is the best.~     Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal~     treatment of the prostate using temporary implantation of radioactive seeds into the prostate~     which the investigators hope will be less since the entire prostate is not treated.~   "
151460|NCT01583907|"~     The investigators aim to asses the effect of dieto-therapy and of nutritional counseling on~     the nutritional status, body growth and tolerance acquisition in children with cow's milk~     allergy.~   "
151461|NCT01583894|"~     This study will collect pain-related information from chronic pain patients to gain an~     understanding of the prevalence of multi-site pain, and how it affects health outcomes like~     function, quality of life, depression, and anxiety.~   "
151462|NCT01583881|"~     Increasing evidence suggests an important role of activation of the sympathetic nervous~     system (SNS) in the clinical phenomena of heart failure with normal left ventricular ejection~     fraction and hypertension. The current study aims to evaluate efficacy and safety of renal~     sympathetic denervation for the modulation of the SNS in patients with heart failure with~     normal LV ejection fraction.~   "
151463|NCT01583855|"~     Atrial fibrillation is a common form of heart rhythm disturbance that for some patients is~     treated by catheter ablation (making an ablation lesion or burn inside the heart using a fine~     wire (catheter)). A new system for manipulating the catheters has recently been introduced~     into clinical practice (the Amigo Remote Catheter System (RCS)). This trial is designed to~     answer two primary questions: a) is the contact force (the force with which the catheter~     comes into contact with the heart) any different using the RCS to manual techniques,and b)are~     the resulting ablation lesions within the heart any different in terms of the volume and~     contiguity of the lesions produced. Additionally the investigators aim to determine how the~     two techniques compare in success (the proportion of patients whose heart rhythm disturbance~     is corrected by the procedure).~   "
151464|NCT01583842|"~     This is a pilot study with the primary purpose to describe organ dosimetry and acute~     toxicities using no carrier added and carrier added 124I-MIBG PET/CT in patients with~     neuroblastoma (NB). Eligible patients are 3 years of age and older with relapsed or~     refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.~     After all eligibility criteria are met, patients will receive a diagnostic imaging dose of~     124I-MIBG followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Subsequent,~     planned therapeutic administration of 131I-MIBG will occur between Days 7 to 21, as specified~     by the patient's therapeutic MIBG protocol. An optional single follow up 124I-MIBG PET-CT~     scan will be done to assess tumor sites 6 weeks after the patient has their MIBG therapy.~   "
151465|NCT01583829|"~     This study examines the efficacy of two computer-based attention training systems, one with~     and one without neurofeedback. The training systems intend to help children learn to focus~     and attend more effectively.~   "
151466|NCT01583816|"~     A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple~     Actinic Keratosis Lesions~   "
151467|NCT01583803|"~     Females have a lower incidence of hypertensive and cardiovascular disorders that may relate~     to differences in nitrogen oxides in the blood and saliva. Some nitrogen oxides are recycled~     with the help of oral bacteria to nitric oxide which is protective against vascular~     disorders. This study will test the hypothesis that females have different numbers and~     species of these nitrogen-oxide reducing bacteria.~   "
151468|NCT01583790|"~     The purpose of this study is to report data with patients after bariatric surgery.~   "
151469|NCT01583777|"~     The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of~     belinostat following IV administration in patients with a recurrent or progressive~     malignancy.~   "
151470|NCT01583751|"~     This study examines performing pilonidal sinus surgery minimal invasively with~     videoendoscopic approach.~   "
151471|NCT01583738|"~     Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.~   "
151473|NCT01583712|"~     Early diagnosis of acute Gastrointestinal Graft-versus-Host disease (aGI-GvHD) has a strong~     impact on morbidity and mortality of patients who underwent haematopoietic stem cell~     transplantation (HSCT). Recent results at the investigators department showed that mucosal~     biopsies from the small intestine have a high diagnostic yield for aGI-GvHD specific changes.~     By performing an enteroscopic examination, aGI-GvHD suspected patients can be prevented from~     colonoscopy and prior bowel preparation which is clinically important, considering the rather~     bad general condition of this patient group. To further reduce invasive procedures the~     investigators want to evaluate the in vivo histological features of aGI-GvHD in the small~     bowel. Therefore aGI-GvHD suspected patients will undergo confocal laser endomicroscopy of~     the upper GI-tract, including duodenum and jejunum, in the context of a prospective clinical~     pilot trial. The histological evaluation of biopsy samples taken from these sites will be~     used as comparable gold standard. Endomicroscopic aspects of patients with celiac disease,~     infectious enteritis, inflammatory bowel disease and healthy subjects should serve as~     controls. If it is possible to diagnose aGI-GvHD from endomicroscopic features of the small~     bowel alone, this could be another important step to improve the diagnostic management of~     post HSCT patients, especially when taking of biopsy samples is difficult because of a bad~     coagulation status. Additionally, an accurate diagnosis in vivo could lead to immediate~     treatment to prevent progression and site spreading of the disease.~   "
151474|NCT01583699|"~     Extranodal marginal zone B-cell lymphoma (MZBL) of the mucosa associated lymphoid tissue~     (MALT-lymphoma) represents a distinct clinical entity and is the most common form of~     extranodal lymphoma, with a predilection for the stomach. About 90% of gastric MALT-lymphomas~     are associated with infection with Helicobacter pylori (HP) and eradication of the pathogen~     leads to regression of the tumor in a high percentage of patients at early tumour stages.~     Nevertheless, following complete remission after HP-eradication, the risk of relapse~     justifies lifelong follow-up examinations. Supported by recent findings at the investigators~     department, endoscopic controls should include a close examination of the small bowel, as~     relapses can involve different gastrointestinal sites. To continue the investigators~     diagnostic approach as well as to further improve the detection rate of MALT-lymphoma~     relapses, the investigators plan to introduce the novel confocal laser endomicroscope (CLE)~     into the diagnostic management of MALT-lymphoma patients. In the context of a prospective~     clinical pilot trial the investigators aim to establish MALT-lymphoma specific CLE-markers~     that can be used for the in vivo diagnosis of the disease. Comparing endomicroscopic~     findings, drawn from the stomach and small bowel of 50 MALT-lymphoma patients who will~     undergo staging or follow up endoscopies at the investigators department, to the histological~     evaluation of biopsy samples as present gold standard, the investigators want to determine~     whether CLE can provide reliable data for the accurate detection of MALT-lymphoma associated~     changes. Endomicroscopic aspects of patients with chronic gastritis, gastric adenocarcinoma~     and healthy subjects should serve as controls. In comparison to random biopsies which~     represent the current standard, the investigators aim to prove, whether endomicroscopy will~     find MALT-lymphoma lesions more accurately and thus help to spare patients unnecessary~     biopsies.~   "
151475|NCT01583686|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     metastatic cancer that involves taking white blood cells from the patient, growing them in~     the laboratory in large numbers, genetically modifying these specific cells with a type of~     virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the~     patient. This type of therapy is called gene transfer. In this protocol, we are modifying the~     patient s white blood cells with a retrovirus that has the gene for anti-mesothelin~     incorporated in the retrovirus.~      Objective:~      The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these tumor fighting cells (anti-mesothelin cells) cause metastatic cancer tumors to~     shrink.~      Eligibility:~      - Adults age 18-70 with metastatic cancer expressing the mesothelin molecule.~      Design:~      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo~     a history and physical examination, scans, x-rays, lab tests, and other tests as needed~      Leukapheresis: If the patients meet all of the requirements for the study they will undergo~     leukapheresis to obtain white blood cells to make the anti-mesothelin cells. {Leukapheresis~     is a common procedure, which removes only the white blood cells from the patient.}~      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the~     conditioning chemotherapy, the anti-mesothelin cells, and aldesleukin. They will stay in the~     hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.~   "
151476|NCT01583673|"~     The primary objective of the clinical trial is to compare growth in infants (expressed as~     weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially~     available hypoallergenic formula over a period of 4 months.~   "
151477|NCT01583660|"~     With the development of society, aged population is growing. Hip fracture is the most common~     disease for aged people. With the life being longer than before, incidence of this disease is~     growing. The mortality of this disease is high—— almost 10% patients will die within 1 month,~     about 1/3 of patients will die within 12 months. About 20%-30% aged people who have hip~     fracture will die within one year.~      The damaged organs caused by excessive inflammatory is one of possible reasons to cause~     higher mortality. Therefore, the investigators imagined that if they gave medicines to~     patients in time to reduce the inflammatory level, the inflammatory might have less effects~     on organs, and the recovery could be improved.~      The investigators hypothesis on the basic research: the anti-inflammatory function of non~     steroidal antiinflammatory drugs (NSAIDs) can inhibit the inflammatory level of elderly hip~     fracture, so as to improve the recovery level and reduce the complicating disease and~     mortality. The investigators designed a clinic study to research NSAIDS' effects on~     inflammatory level and prognosis of elderly hip fracture.~   "
151478|NCT01583647|"~     The purpose of this study is to determine the pharmacokinetics of laropiprant following~     administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of~     MK-0524A in adolescents with heterozygous familial hypercholesterolemia.~   "
151479|NCT01583634|"~     Accuracy of the oximeter.~   "
151480|NCT01583621|"~     Primary Specific Aim 1: To compare the dose-responsive effects of vitamin D3 supplementations~     on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium.~      Primary Specific Aim 2: To compare the dose-responsive effects of vitamin D3 supplementations~     on non-invasive vascular measures including pulse wave velocity (PWV), flow-mediated dilation~     (FMD), carotid arterial compliance (CAC), carotid Intima-Media Thickness (cIMT), and 24-hours~     Ambulatory Blood Pressure (ABP) monitoring as well as casual BP.~   "
151481|NCT01583608|"~     The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting~     bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery~     lesions in all-day clinical practice.~   "
151482|NCT01583595|"~     Most patients with chronic lung disease underestimate their actual walking ability due to low~     confidence. To better understand the relationships between lung function, self-efficacy for~     walking (confidence in ability to walk a defined distance), actual walking ability for the~     same distance gait speed and physical activity level-PAL- (total energy expenditure/resting~     metabolic rate).~      Quality of life, self efficacy for activity questionnaires, physical activity level~     measurement, 4-meter gait speed and 6-minute walk distance will be measured.~   "
151485|NCT01583556|"~     Many common arm fractures have an excellent prognosis with little more than symptomatic~     treatment. When studying these fractures, investigators find that a substantial number of~     patients do not attend follow-up appointments. The difficulty of maneuvering in big cities,~     the cost of parking, the co-pay for the visit and the wait times for x-ray and doctor are all~     inconveniences that some patients might prefer to avoid. Building on prior research, it is~     appropriate to offer patients with common minor upper extremity fractures that have an~     excellent prognosis optional follow-up after the first visit. The plan would be to be~     available by phone, email and subsequent appointment at the patient's discretion if they felt~     that the recovery was off course. Benefit to individual participants is unlikely. The study~     will benefit the society as a whole, by providing a better understanding of these common~     fractures. It can also affect the economics of our health system by avoiding further~     follow-up appointments.~      Primary null hypothesis: There is no difference in patient outcome 2-6 months after injury~     between patients that return for a second visit, and patients that do not.~      Secondary null hypothesis: There is no difference in patient satisfaction 2-6 months after~     injury between patients that return for a second visit, and patients that do not.~   "
151486|NCT01583543|"~     This research study is a Phase II clinical trial to test the efficacy of Olaparib in adult~     participants with recurrent/metastatic Ewing's Sarcoma following failure of prior~     chemotherapy.~   "
151487|NCT01583530|"~     The purpose of this study is to measure the amount of belimumab in the blood when given as an~     injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of~     multiple injections under the skin in healthy subjects.~   "
151488|NCT01583517|"~     The therapeutic impact of ERCP with sphincterotomy in the management of patients with~     idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators~     conducted a single center, feasibility, randomized trial to determine 1) the role of~     pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy~     of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).~   "
151489|NCT01583504|"~     Hypothesis: High volume saline injections are an effective pain relieving treatment for~     people with longstanding pain in the achilles tendon which has not improved with a~     physiotherapy programme.~      Objective 1: To establish whether high volume saline injections are an effective treatment in~     decreasing pain for people with achilles tendinopathy~      Objective 2: To investigate whether high volume saline injections can improve day to day~     functioning, quality of life and the ultrasound appearances of the tendon for people with~     achilles tendinopathy~      Objective 3: To assess the tolerability of the procedure and levels of patient satisfaction~     using a simple questionnaire.~      Objective 4: To follow up the cohort of people who have received the injection for 9 months~     and ascertain whether any benefits persisted, or if the symptoms recurred.~      Background: Achilles tendon disorders are a common problem for athletes with a lifetime risk~     of around 50%. They are also common for less active people with a lifetime risk of around 6%.~      Tendinopathy is a condition which is characterised by pain, difficulty with weight bearing~     and swelling of the tendon. Symptoms may occur with exercise at first but can progress to~     occurring at rest and interfering with day to day activities. When the problematic tendon is~     examined under the microscope, it usually shows signs of degeneration rather than~     inflammation - especially when symptoms have been persistent. An ultrasound scan will usually~     show that the tendon is swollen with an increased water content and a disorganised tendon~     structure.~      A special type of ultrasound scan which looks at fluid flows, called a doppler ultrasound,~     often shows areas of increased blood flow around the tendon. Studies have shown that when~     these areas of increased blood flow are present, the patient tends to be experiencing more~     pain and stiffness in the tendon. Under the microscope, these blood vessels are often~     accompanied by nerve fibres and it has been suggested that these newly growing nerve endings~     are responsible for the persistent pain that patients experience.~      There is robust evidence that a particular type of exercise programme (eccentric loading) is~     an effective treatment for achilles tendinopathy. These exercises involve taking weight on~     the tendon whilst it is being compressed rather than stretched - heel lowering exercises.~     Nevertheless after completing a 3 month eccentric loading exercise programme, around 24-45%~     of patients will still have symptoms. There is no clear consensus amongst doctors as to what~     is the best second line treatment to try for this group of people.~      A number of different treatments have been described in research literature to try to treat~     this group of people with persistent symptoms, although no firm conclusion can be reached.~     There have been 2 small trials of high volume saline injections which showed some promising~     potential for the treatment. The aim of this injection is to destroy the blood vessels and~     nerve endings that grow into the swollen tendon to reduce pain and allow people to move and~     exercise more normally using the tendon. These studies simply looked at before and after~     injection results and did not compare the injections to a placebo or other treatment. The aim~     of this project is to conduct a high quality comparison of this new type of injection against~     a more common steroid and local anaesthetic injection around the tendon sheath. The design of~     the trial is a double blind, randomised controlled trial. This means that neither the~     patient, nor the doctor collecting data on pain scores knows which treatment the participant~     has been given, allowing a fair comparison of the interventions.~      The main comparisons between the 2 groups will take place at a 6 week follow up appointment.~     Once outcome measures have been recorded by the blinded assessor, the participant will then~     be told which arm of the study they are on. If they previously received the control injection~     (steroid and local anaesthetic only)and they still have symptoms, they will at this stage be~     offered the high volume saline injection as well. The investigators will then follow all of~     the study participants up for 9 months to ascertain whether people show a persistent benefit~     from the treatment, or whether symptoms subsequently return.~      The full study protocol is available on request from the Principle Investigator, along with~     information leaflets, ethical approvals etc.~   "
151490|NCT01583491|"~     The purpose of this study is to determine the influence of platelet rich fibrin to reduction~     of periodontal problems after surgical removal of third molar.~   "
151491|NCT01583478|"~     The objective of the study is to compare the efficacy and duration of escalating doses of~     IncobotulinumtoxinA (Xeomin®) in the treatment of glabellar rhytids (frown lines between the~     eyes). Fifteen subjects will be enrolled in the study; specifically 60 male or female~     patients 18 years of age or older with moderate to severe glabellar rhytids at maximum~     contracture. Each patient will be randomized to receive one of 5 doses of Xeomin®, in a~     one-time dose to the treatment area.~      The efficacy endpoints will be determined by investigator and subject live assessment of the~     glabellar rhytids at rest and maximum contraction at each visit (every other day for 6 days~     post-injection, every month for 9 months following) using a validated 4 point photographic~     scale (minimal wrinkles [0], mild wrinkles [1], moderate wrinkles [2], or severe wrinkles~     [3]) used in previous studies. A written description of each photograph will be included to~     help standardize the application of the Photographic Scale.~   "
151492|NCT01583465|"~     The purpose of this study is to establish whether or not there is a clinical advantage to the~     use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical~     Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine~     intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound~     healing will be assessed by a blinded observer and based upon a simple and subjective~     criteria: a) as expected, b) better than expected or c) worse than expected. The blinded~     observer is experienced in the care of the surgical patient and wound evaluation.~   "
151493|NCT01583452|"~     Post- operative ileus refers to the time after surgery before coordinated electromotor bowel~     function resumes. It's treatment and prevention may signify an elevated hospitalization cost~     and the exposure to the patient to adverse effects of drugs.~      The current clinical trial has as primary objective to prove the efficacy of chewing gum as a~     preventive measure of post-operative ileus in pediatric patients after gastrointestinal~     surgery through the determination of the time the patient takes to tolerate oral intake, pass~     flatus, present bowel movements and the time of hospital stay.~      Patients will be assigned either to the case group (chewing gum + standard treatment) or to~     the control group (standard treatment), in both of them time from the end of surgery to the~     moment the patient presents first bowel movement, passes flatus, tolerates oral intake (any~     type of food) and is discharged from hospital; will be measured in hours and then analyzed to~     determine the validity of these data.~   "
151494|NCT01583439|"~     The goal of the Mochudi Prevention Project is to reduce the number of new HIV infections in~     the village of Mochudi, Botswana by promoting a comprehensive package of interventions that~     have proven to be effective in preventing the spread of HIV. This antiretroviral treatment~     (ART) clinical study is nested within the Mochudi Prevention Project, and is being conducted~     in the north-east segment (NES) of the village of Mochudi. The ART intervention component of~     the Mochudi Project is designed to determine the uptake of, adherence to, and feasibility of~     3-drug combination ART as a component of a package of transmission prevention strategies. The~     hypotheses are 1) that ART (with 3 antiretrovirals from two classes of drugs) among~     participants with CD4 ≥ 250 cells/mm3 and VL ≥ 50,000 cp/mL will be acceptable and safe and~     2) Eighty percent of eligible participants will agree to start 3-drug ART.~   "
151503|NCT01583322|"~     Patients with extensive and bulky disease are often those whose initial surgery is delayed~     after 3 or 4 cycles of neo-adjuvant chemotherapy.~      In that case, there is, indeed, some concern to administer bevacizumab during the~     chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21~     days) of this monoclonal antibody and the interference of anti angiogenic agents with wound~     healing.~      Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant~     setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary~     experience in cancer did not show a trend for increased incidence of fistula or bowel~     perforation. For more details please refer to the investigator drug brochure for Vargatef®~     (Nintedanib).~      This trial will compare progression-free survival and surgical complications of 188 patients~     with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy~     (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef®~     (Nintedanib).~   "
151495|NCT01583426|"~     Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast~     cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles~     of TAC based on previous large scale studies.~      Treatment of patients with HER2-positive disease should include also simultaneous application~     of trastuzumab.~      Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active~     agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a~     solvent-free formulation of paclitaxel encapsulated in albumin. It does not require~     premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated~     hypersensitivity reactions. This new formulation improves safety profile, allows higher~     dosing with shorter infusion duration, and produces higher tumor drug concentration.~      As neoadjuvant treatment does not only allow to compare competing treatment approaches with a~     very high quality (homogenous treatment population, precise assessment of response by~     histological assessment), but also to identify predictive markers, this trial will compare~     weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses.~      In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab~     additionally.~   "
151496|NCT01583413|"~     Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation~     associated with significant morbidity, including prolongation of mechanical ventilation and~     increased ICU and hospital length-of-stay. Numerous strategies have been proposed to decrease~     the occurrence of VAP among ventilated patients. Most notably, optimizing the use of daily~     sedative interruptions and daily spontaneous breathing trials can improve sedative~     management, decrease ventilator time, improve outcomes for mechanically ventilated~     patients,and possibly decrease VAP.Combining daily sedative interruption with daily~     spontaneous breathing trials confers additive improvement in ventilator days, intensive care~     days, and possibly mortality compared to daily spontaneous breathing trials alone.~      The primary aim of this study is to determine the impact of an opt-out protocol for paired~     daily sedative interruptions and spontaneous breathing trials on VAP rates using a new~     streamlined VAP definition. The investigators will evaluate the responsiveness of CDC's~     proposed new surveillance definitions for ventilator-associated events to this quality~     improvement initiative. The study will be nested within the Epicenters Streamlined versus~     Conventional VAP Surveillance Study. Nine of the 18 hospitals in the larger study will be~     participating in this intervention arm.~   "
151497|NCT01583400|"~     Primary care physicians have emerged as the predominant mental health care providers for~     diagnosing and treating depression. The majority of patients with mood disorders receive~     treatment in the primary care setting, within which approximately 10-30% of all patients~     present with a depressive disorder. Comprehensive 'Collaborative Care' models of depression~     management significantly improve depression outcomes and health-related quality of life. Core~     features of these programs include use of a trained depression care manager to closely~     coordinate with primary care clinicians, support treatment recommendations, provide patient~     education, conduct patient follow-up to ensure adequate treatment, and manage as-needed~     access to psychiatrists for patients with more complex presentations. Evidence based~     Collaborative Care models do not currently weave in the use of web-based or mobile~     technologies. These technologies offer unique features that may make collaborative depression~     care more effective. The digital health coaching program for depressive symptoms enhanced~     during Phase I of the current project is a web-based tool featuring video, text, links and~     graphics which provide patients with education, self-management techniques, tailored~     feedback, and tools for tracking treatment progress. The RESPECT-D (Re-engineering Systems of~     Primary Care Treatment of Depression) intervention is a collaborative depression management~     model for primary care. The primary objective of this project is to compare the efficacy of~     an enhanced Collaborative Care model for depression (RESPECT-D-E) to the standard model~     (RESPECT-D) for patients with minor and major depression and dysthymic disorder. This study~     will be a randomized controlled trial with 150 participants who are receiving antidepressant~     medication treatment in the primary care setting. The primary objectives are: reduction in~     subject reported depressive symptoms, improvement in subject reported health related quality~     of life and improvement in subject adherence to treatment regimen as demonstrated by~     self-report measures and clinician-administered assessment. The investigators hypothesize~     that compared to RESPECT-D at 12 weeks, participants randomized to RESPECT-D-E will~     demonstrate: a greater reduction in depressive symptoms, a greater improvement in~     health-related quality of life and a greater satisfaction with quality of depression care~     received.~   "
151498|NCT01583387|"~     The main purpose of the study is to assess the effect of water intake on the formation of~     4-ABP DNA adducts.~   "
151499|NCT01583374|"~     Apremilast is a new, orally available, small molecule drug that specifically inhibits~     phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical~     study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.~   "
151500|NCT01583361|"~     This is a randomized, multicenter, controlled trial to prove efficacy of S‐1 and Oxaliplatin~     as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.~      The primary endpoint is three-year free disease and the second primary includes five-year~     overall survival, safety and R0 resection rate.~   "
151501|NCT01583348|"~     While gold standard in the treatment of symptomatic gall stones is laparoscopic~     cholecystectomy with instruments introduced through multiple abdominal wall incisions,~     transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the~     abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and~     safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is~     feasible during such procedure. This observational case series describes success and~     technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy.~     The investigators hypothesis is that cholangiography is feasible equal to conventional~     laparoscopic cholecystectomy.~   "
151502|NCT01583335|"~     Obesity prevention should remain a priority, although there is some evidence of a possible~     leveling off in some age groups across European countries and in USA, Japan and Australia.~     Besides adult health problems such as type-2 diabetes and cardiovascular diseases, obesity in~     childhood is associated with psychological and social problems, low self-esteem,~     stigmatization and being teased and bullied by friends. Danish research suggests that the~     causes behind the increase in obesity occurrence are present already in early childhood, and~     that prevention of obesity therefore has to start early. Research has suggested that at least~     three sub-groups can be considered at high risk of becoming obese: Children with obesity~     among their 1st degree relatives; children with a high birth weight or children coming from~     socially disadvantaged families (low socioeconomic status). Earlier intervention programs has~     showed little effect in preventing excessive weight gain and knowledge on how to develop~     effective intervention programs that reduce overweight and obesity remains limited. It has~     been suggested that future prevention programs may be more successful if specifically~     targeting groups that are at high risk, as mention above, of excessive weight gain.~      Based on these suggestions, the Sund Start project was initiated. The purpose of the study~     was to determine whether aiming prevention towards 2-6 years old Danish children who were yet~     normal weight, but were considered predisposed to becoming overweight or obese could prevent~     later on risk of becoming overweight or obese. Furthermore, to investigate if it was possible~     to improve diet habits, increase physical activity, reduce stress and improve sleeping habits~     among children at high risk for later on overweight and obesity.~      The Sund Start project will contribute with knowledge about whether targeting normal~     weight, predisposed children is effective in preventing overweight and obesity, and if~     reduced stress and improved sleep, should be considered important new obesity prevention~     tools. Moreover, the project will contribute with knowledge about how to change lifestyle and~     its effects on development of overweight and obesity in high risk Danish preschool children.~   "
151670|NCT01581125|"~     The purpose of this study is to test the hypothesis that sleep and performance depend on~     length of time awake, length of time asleep, the amount of sleep over several sleep episodes,~     and circadian phase.~   "
151505|NCT01583296|"~     The research plan involves two aims: 1) Cultural adaptation of the Panic-Asthma Treatment and~     2) a randomized, placebo-controlled pilot study. Participants will be primarily recruited~     from two major, inner-city hospitals in the Bronx, NY. Diagnosis of Panic Disorder (PD) will~     be based on the Structured Clinical Interview for DSM-IV. Diagnosis of asthma will be based~     on national guidelines. The first year of the project will be devoted to approximately 5~     focus groups with Latino (primarily Puerto Rican) participants, pilot treatment and~     participant feedback. The protocol will be adapted based on key cultural issues that are~     systematically observed during Phase 1. During Years 2-3, 40 participants with PD and asthma~     will be randomized into two treatment arms: Panic-Asthma Treatment and an active placebo~     condition involving music therapy and paced breathing at resting respiration rates. Each~     treatment will involve 8 weekly sessions. An interviewer, who will be blind to treatment~     condition, will conduct assessments at pre-treatment, mid-treatment, post-treatment, and~     3-month follow-up. The primary hypotheses are that participants in the Panic-Asthma treatment~     group will have greater decreases than subjects in the placebo condition on the PD severity~     scale and albuterol use (i.e., rescue asthma medication) from pre-test to post-test and~     across 3-month follow-up.~   "
151506|NCT01583283|"~     The purpose of this study is to determine the best dose of ACY-1215 in combination with~     lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory multiple~     myeloma. Once determined, the purpose of this study will be to determine the efficacy of~     ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed~     multiple myeloma who have had 1-3 prior therapies and who are not lenalidomide-refractory.~   "
151507|NCT01583270|"~     Sedentary lifestyles and increasing obesity are main causes of the global increase in the~     prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality,~     particularly composition of carbohydrate play also a significant role. Barley, oat and rye~     may in addition to reducing the acute post prandial glucose response also reduce glucose~     response at a subsequent meal. Purified dietary fibre has been shown to reduce GI and affect~     levels of satiety hormones. In contrast, our knowledge of the physiological effect of~     arabinoxylan, which constitute a substantial part of dietary fibre in cereal products, is~     limited in relation to second meal effects. The investigators also lack knowledge of the~     second meal effect of arabinoxyan in combination with rye kernels.~      Hypothesis: Porridge rich in arabinoxylan and/or whole rye kernels can increase the formation~     of short chain fatty acids and improve the glycemic response.~      The aim of the present study is to compare the effect of porridge test meals based on~     purified arabinoxylan, rye kernels, a combination of arabinoxylan and rye kernels, and~     semolina porridge as control on acute postprandial response as well as response at a~     subsequent standardized meal. The study will be conducted in subjects with the metabolic~     syndrome. The primary endpoint is glucose response. Secondary endpoints are the following~     items: insulin, incretins, inflammatory markers, ghrelin, free fatty acids, metabolomics,~     breath hydrogen and subjective satiety feeling.~      This project will improve opportunities for identifying and designing foods with low GI that~     is particularly suited to people who are at high risk of developing T2DM. The investigators~     also expect to gain a greater understanding of the metabolic fingerprint, as seen after~     ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods~     affect health by altering metabolic processes. This will give us a deeper insight into the~     metabolic processes that are necessary for maintaining normal glucose homeostasis~   "
151508|NCT01583257|"~     Background:~      Renal transplant recipients have a greater risk of morbidity and mortality primarily due to~     cardiovascular disease when compared to the general population. Cardiovascular disease is~     responsible for 50% to 60% percent of deaths amongst renal transplant population and death~     from cardiovascular disease is a leading cause of functioning graft loss.~      Physical activity is an effective form of secondary prevention in existing cardiovascular~     disease reducing all-cause mortality by 25%-30% and has demonstrated positive effects overall~     on quality of life and well-being. Transplant patients who participated in regular~     cardiovascular exercise have significant more positive scores on the SF-36 Health Status~     Questionnaire in comparison to inactive transplant recipients.~      Active video gaming is evolving as an innovative method to increase physical activity. Active~     video gaming has supported physical activity in children and youth. There is however a~     paucity of literature examining interactive games as a means to facilitate physical activity~     and its impact on CVD and quality of life in the adult population nor any literature~     examining AVG and its impact on an adult surgical population.~      This pilot study is designed to determine if Active Video Gaming is feasible and is able to~     lead to behavioral modifications and Quality of Life improvement.~      Subject Selection:~      This is a pilot study during which 10 patients who have undergone renal transplant will be~     selected to exercise with Active Video Gaming for a duration of 3 months. The program~     activity will begin 6 months post surgery.~   "
151509|NCT01583244|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Orencia® so that the regulatory authority can manage the marketing approval~     properly.~   "
151510|NCT01583231|"~     The aim of this research is to examine if the brushless scrub is effective in reducing~     bioburden on the hands of the operating room (OR) personnel both with a prewash of one minute~     prior to scrub and without a prewash prior to scrub, and to compare the bioburden reduction~     between both methods.~      Hypothesis I: A soap and water prewash used prior to brushless scrub further decreases~     bioburden than brushless scrub alone.~      Hypothesis II: Brushless scrub is effective in reducing the bioburden measured just after the~     application of the brushless scrub within 20 seconds of application for both groups.~      Exploratory Hypothesis: We will also compare the bioburden measured before and at 1.5 minutes~     after application of the brushless scrub for both groups.~   "
151511|NCT01583218|"~     The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban~     can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for~     an acute medical illness and to compare these results with standard of care enoxaparin. The~     safety of betrixaban will also be studied.~   "
151554|NCT01582659|"~     Constipation is a condition often seen in children. Constipation is often associated with~     impaired quality of life of the child and of great concern among parents. Despite the fact~     that both diagnosis and treatment is a simple task, it is often seen that the treatment~     fails, and many children are referred to a pediatric ward for specialized treatment.~      There is currently little research on the subject and treatment is therefore based on expert~     knowledge rather than scientific research.~      The study objective is to identify the most effective and least stressful treatment of~     children with constipation for both families and the health care system.~      The following will be tested:~      Does treatment of constipation in children require specialized knowledge and extensive~     resources or can the treatment be simplified?~      The results from this study are expected to form the basis for a evidence based treatment of~     children with constipation.~   "
151512|NCT01583205|"~     The investigators propose to adapt and pilot test a behavioral intervention for recently~     diagnosed patients with Amyotrophic Lateral Sclerosis (ALS), and/or a family care partner.~     ALS fatal neurodegenerative disease, the diagnosis of which can have a devastating impact on~     patients and their families. Our eight session intervention is derived from Coping~     Effectiveness Training, a manualized intervention based on stress and coping theory. It is~     designed to strengthen coping skills and alleviate distress following diagnosis.~      Participants (patients and/or care partners) will be recruited from the Eleanor and Lou~     Gehrig MDA/ALS Research Center, Columbia University. The main outcomes are changes in~     distress level, depression and anxiety symptoms, and coping self-efficacy.~      Once the investigators gain preliminary experience with the manual, get some sense of~     feasibility and acceptance, and learn about patient and care partner reactions, the~     investigators will be better able to prepare a grant application seeking NIH support for the~     development of the intervention, with the eventual goal of a multisite randomized controlled~     trial (RCT).~   "
151513|NCT01583192|"~     The study will prospectively compare the efficacy and safety of chloride hexidine soluted in~     alcohol with povidine-jodine soluted in alcohol in forefoot surgery.~   "
151514|NCT01583179|"~     The patients included will be those who have already agreed to have a brachial plexus nerve~     block for surgery. A flip of the coin will decide who gets and additive called buprenorphine~     in their block or not. They will both contain the same amount and type of numbing medicine.~     The goal will be to see if the additive extends the life of the pain control portion of the~     ultrasound guided supraclavicular nerve block.~   "
151515|NCT01583166|"~     The purpose of this study is to determine if there is a difference in post-operative voiding~     function between subjects receiving local anesthetic and those receiving placebo at the time~     of mid-urethral sling placement. The secondary objective is to evaluate pain after the~     procedure in the two groups.~   "
151516|NCT01583153|"~     Total knee replacement (TKR) surgery is a common and highly effective treatment option for~     alleviating the pain and disability caused by chronic arthritis. The associated~     rehabilitation costs, however, impose a significant burden on the health system. In~     particular, inpatient rehabilitation - utilised by approximately 43% of private TKR~     recipients in NSW and 29% Australia-wide is of greatest concern, costing, on average, $7000~     (AU) per inpatient episode.~      The overarching aim of this study is to establish whether inpatient rehabilitation is~     necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged~     directly home.~      The main hypothesis to be tested by the proposed study is that TKR recipients who receive~     inpatient rehabilitation in addition to participating in a home programme, compared to~     patients who participate in a home programme only, will achieve a superior level of mobility.~     If superiority is shown, a cost-effectiveness analysis will be undertaken.~      Secondary hypotheses to be tested relate to patient-reported knee pain and function,~     health-related quality of life, functional ambulation, and knee joint mobility.~      Superiority in these outcomes will be evident at six months after surgery.~   "
151517|NCT01583140|"~     In this study the investigators are specifically targeting Latina women because they are more~     likely to be inactive and, therefore, are at higher risk for developing chronic conditions~     like obesity, diabetes, or cardiovascular disease. Through focus groups and cognitive~     interviews with Latinas in the Providence area, the investigators have modified our~     print-based intervention, already tested and proven to be effective in English-speaking~     communities, to be culturally and linguistically appropriate for the Latina community.~      The objective of Seamos Saludables is to determine whether this culturally tailored print~     intervention will produce greater increases in physical activity levels among Latina women~     than a program focused on general health topics. Participants are randomly assigned to one of~     two groups (exercise and general wellness) and attend 4 clinic visits to complete baseline~     and follow-up assessments.~      The investigators hypothesize that at the end of treatment, intervention participants will~     report significantly more minutes of at least moderate intensity physical activity per week~     than the wellness contact control participants.~   "
151518|NCT01583127|"~     To conduct a randomized controlled trial of School-Wide Positive Behavioral Interventions and~     Supports, which is a school-based prevention program aimed at reducing behavior problems in~     children.~   "
151519|NCT01583114|"~     This is a multicentre European double-blind,randomized and controlled trial with 2 parallel~     groups (1 study medication, 1 placebo) in order to analyse the impact of ACE inhibitors~     (ACEi) in subjects who carry a mutation but have not yet developed DCM (dilated~     cardiomyopathy).~      Objective of the trial: Study the impact of ACE inhibitors (ACEi) in subjects who carry a~     mutation (leading to a genetic form of heart failure) but have not yet developed DCM.~      Context. Dilated Cardiomyopathy (DCM) is one of the leading causes of Heart Failure due to~     systolic dysfunction and at least 30% of DCM are of familial/genetic origin, usually with~     autosomal dominant inheritance, and underlying genes and mutations are increasingly~     identified. Familial Dilated Cardiomyopathy (fDCM) is characterized by age-related penetrance~     (or delayed-onset), that means that the cardiac expression of the disease (echocardiographic~     abnormalities) is usually absent for a long period and progressively appears with advanced~     age, usually after 20 years of age~      Hypothesis : ACEi may delay or prevent the occurrence of DCM in these subjects (pre-clinical~     stage).~      Expected results: If the hypothesis is confirmed, and as a consequence, the knowledge derived~     from basic research (genes identification in DCM) will be translated into clinical practice~     (early identification of subjects at high risk of developing heart failure through predictive~     genetic testing) with the development of new therapeutic management (early ACEi) that will~     help to decrease the morbidity and mortality associated with the disease. This will~     constitute a paradigm of the development of preventive medicine thanks to the development of~     genetics in the cardiovascular field.~      Subjects who are concerned are ≥18 years of age and ≤60 years, carry a mutation responsible~     for DCM and are at a preclinical stage of the disease. Total duration of treatment~     (perindopril versus placebo) is 3 years. A total number of 200 participants will be enrolled~     (100 in each group) in 7 centres.~   "
151520|NCT01583101|"~     The investigators have developed a novel decision support system for implementing clinical~     guidelines in pediatric practice. CHICA (Child Health Improvement through Computer~     Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a~     dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing~     electronic medical record systems. The result is a system that both delivers just-in-time~     patient-relevant guidelines to physicians during the clinical encounter, and accurately~     captures structured data from all who interact with it. Preliminary work with CHICA has~     demonstrated the feasibility of using the system to implement and evaluate clinical~     guidelines.~      However, analyses have shown that physicians ignore a fair number of prompts. The~     investigators would like to experiment with changes to the system to see if they can increase~     physicians' response rates. This could include highlighting prompts, reordering them, or~     flagging them in other ways. The main outcome of interest in the rate at which physicians~     answer prompts.~   "
151521|NCT01583088|"~     ALS is is characterized by a progressive degeneration of motor neurons, leading to~     progressive weakness of muscles, including respiratory muscles, the diaphragm. Although~     specific therapy is lacking, correct respiratory therapy improves quality of life and~     increases survival. Substituting the failing respiratory muscles by non invasive mechanical~     ventilatory assistance (NIV) is the current standard of care. Intradiaphragmatic phrenic~     nerve stimulation is a new treatment and has been the object of a preliminary international~     proof-of-concept multicenter trial. This trial suggests that the intradiaphragmatic phrenic~     nerve stimulation slows down the rate of decline of the diaphragm. Our new hypothesis is that~     phrenic stimulation induces diaphragm conditioning and can delay the need for mechanical~     ventilation in ALS patients. We will study, during 24 months, 2 groups of 37 patients at the~     beginning of the respiratory dysfunction, using a intradiaphragmatic phrenic nerve~     stimulation in one group and a sham stimulation in the other group. Although, all the~     patients will be implanted, thus, at the end of the study, all the patients will receive~     effective stimulation.~   "
151522|NCT01583075|"~     The single-ring ablation method aims for isolation of the posterior LA wall including the~     pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely.~      Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided~     single-ring ablation method as compared to standard RMN-guided circumferential PVA.~   "
151523|NCT01583062|"~     Facial fractures make up a significant proportion of injuries in trauma patients. Treatment~     of these fractures often results in standard surgical interventions. While up to the early~     1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its~     efficacy is well accepted today. Chole and his team could show that the administration of~     antibiotics one hour preoperatively and eight hours after the intervention reduces the~     incidence of infectious complications in facial fractures from 42,2% to 8.9%. However there~     is still no consensus about the duration of the postoperative administration. In literature~     postoperative prophylaxis in facial fractures varies from single-shot 6-7 up to a duration of~     7 and even ten days postoperatively 8-10. The use of antibiotics can be associated with~     allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial~     resistance. In addition some authors assume that a prolonged administration of antibiotics~     might increase the risk of infectious complications via superinfection. On the other hand a~     short term or single shot administration might not be enough to prevent the onset of an~     postoperative infection. Up to date there is no standard to support the administration of~     antibiotics after surgical repair of a facial fracture.~      The purpose of this prospective, randomized double-blinded trial is to investigate the~     utility of antibiotics administered in the postoperative period after surgical revision of~     facial fractures.~      Hypothesis: a short-term antibiotic prophylaxis of 1 day postoperatively is equally effective~     as a long-term administration of 5 days in facial fractures.~   "
151524|NCT01583049|"~     Primary objective: This is a descriptive study and the primary objective is to determine the~     incidence of injection site and systemic adverse events after Triaxis administration as a 5th~     dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children~   "
151525|NCT01583036|"~     An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite~     NAMR on the pharmacokinetics of digoxin in healthy volunteers~   "
151526|NCT01583023|"~     The purpose of this study is to evaluate whether repetitive transcranial magnetic stimulation~     (rTMS) treatment is an effective adjunct treatment to mood stabilizers and Bupropion.~   "
151527|NCT01583010|"~     Needle tip visualization, although fundamental to the safety and efficacy of~     ultrasound-guided regional anesthesia (UGRA), can be extremely challenging. This problem is~     most marked at steep insertion angles. Studies in patients with UGRA demonstrate that~     echogenic needle designs have the potential to offer improved visibility and accuracy.~      Our study pursues another approach. We use (for differentiation) echogenic nerve block~     needles with ANV®, a new SonoSite software-upgrade (Advanced Needle Visualization~     Technology®). We will compare UGRA with ANV® against standard UGRA without using this~     SonoSite software-upgrade. Patients undergoing femoral, supraclavicular or other nerve blocks~     as part of their routine anesthetic management are included.~      This work represents the first randomized controlled double blinded clinical trial of ANV® in~     patients undergoing UGRA. We hypothesize, that we can decrease the time without needle~     visualization (Loss of needle time in percentage of procedure time) during in-line regional~     anaesthesia. Furthermore we will record quality of visibility, duration of procedure and~     insertion angle of the needle.~   "
151528|NCT01582997|"~     BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This~     study will be designed to assess safety, tolerability, single and repeat dose PK profile and~     preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation positive~     solid tumors using continuous daily dosing schedule.~   "
151529|NCT01582984|"~     A structured consent process, in combination with one or a number of the aforementioned~     modalities (nursing education, handout, video, etc), may reasonably be expected to improve~     surgical informed consent. The investigators hypothesized that overall patient~     knowledge/retention would be influenced by the type of consent process and that more~     intensive training and review would result in better patient retention and recall. The~     investigators further hypothesized that the knowledge retention would decline following the~     consent process and surgery, but in a stratified manner based on the nature of preoperative~     teaching.~   "
151530|NCT01582971|"~     The purpose of this project is to test foot reflexology delivered by a friend or family~     member in the home for women with breast cancer. The primary aims of the proposed study in a~     sample of women with breast cancer receiving chemotherapy and/or hormonal therapy are to~     determine the effects of 4 family- or friend-delivered weekly reflexology sessions compared~     to an attention control group.~   "
151555|NCT01582646|"~     Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants~     (ADs) are recommended as the first line treatment. In a murine model, the investigators~     evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic~     receptor stimulation and that β-mimetics display the same effect. These data support the idea~     that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment.~     This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.~   "
151531|NCT01582958|"~     This project proposes to test the hypothesis that osteopathic manipulative treatment (OMT)~     given to patients with moderate to severe chronic obstructive pulmonary disease (COPD)~     enrolled in a 12-week pulmonary rehabilitation program (PRP) will result in improved~     respiratory pump function over and above that seen in sham and control groups. Specifically,~     we will study the effects of three OMT techniques: (a) thoracic inlet indirect myofascial~     release; (b) rib raising with continued stretch of the paraspinal muscle to the L2 level; and~     (c) cervical paraspinal muscle stretch with suboccipital muscle release. The key clinical~     readouts will include: spirometry, P100 (and index of diaphragm and inspiratory muscle~     efficiency), maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), as~     well as laser evaluation of chest wall excursion. Supplementing these objective parameters~     will be several more subjective clinical outcome measures: exercise tolerance (6-minute walk~     test), dyspnea (shortness of breath questionnaire), and quality of life questionnaire.~     Finally, an attempt will be made to correlate biochemical alterations that may shed light on~     the biological mechanism underlying the OMT procedures.~   "
151532|NCT01582945|"~     Ketamine infusion has been shown to have rapid antidepressant properties, however the~     possible use of ketamine in treatment-resistant depression as augmentation has not been~     investigated. The overall aim of this study is to assess the feasibility, safety and~     tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate~     antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in~     subjects with severe treatment-resistant depression (TRD).~      This is an open-label study (pilot).~   "
151533|NCT01582932|"~     Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects~     with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for~     the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a~     multicenter study evaluating calcipotriene foam, 0.005% in pediatric subjects (ages 2 to 11~     years, inclusive) with mild to moderate plaque psoriasis. Subjects or their primary~     caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day on the body and~     scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and pharmacokinetics of~     calcipotriene will be evaluated.~   "
151534|NCT01582919|"~     It is now acknowledged that Alzheimer's disease is characterized by a long period of~     pathophysiological change. Developing new strategies to achieve diagnoses as early as~     possible has become a major goal for therapies aimed at slowing the progression of this~     disease. While diagnoses currently rely principally on clinical neuropsychology, the typical~     diagnostic criteria of NINCDS-ADRDA are inapplicable in the early stage of the disease. The~     goal of our project is to identify very early imaging markers for Alzheimer's disease among~     patients with no report of cognitive difficulties. In order to achieve this goal, we propose~     a longitudinal study in an elderly population cohort.~   "
151535|NCT01582906|"~     After treatment women surviving gynaecological cancer may experience lateeffects and longterm~     challenges specific to their disease and treatment resulting in functional deficits and a~     reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). The available research~     on best models of posttreatment rehabilitation support for women posttreatment for~     gynaecological cancer is limited. The primary objective of this study is to determine if~     there is any additional benefit, over usual rehabilitation care, of additional rehabilitation~     appointments to develop a survivorship care plan on cancer specific health related quality of~     life.~      Secondary objectives are to determine any additional benefit to general selfefficacy, generic~     health related quality of life or social and health economics for patients who have completed~     treatment for stage I or II gynaecological cancer. Also to explore the patient's perspectives~     of the intervention. The study will be open to patients attending the outpatient~     gynaecological clinics of the Royal Marsden NHS Foundation Trust having recently completed~     treatment for Stage I or II gynaecological cancer. They will report that they have~     experienced a physical or psychosocial need resulting from the disease or its treatment; be~     aged over 18 years and be willing and able to articulate their needs. The study will last for~     six months for each participant. It will involve completing questionnaires and attending two~     extra rehabilitation appointments to develop a survivorship care plan at the hospital may~     also include attending for an interview about being involved in the study for those~     randomised to the intervention group~   "
151536|NCT01582893|"~     Chronic dialysis patients with end stage renal disease have an increased mortality rate as~     compared to the age matched healthy population. It is known that chronic inflammation~     contributes to the high incidence of cardiovascular events in chronic dialysis patients.~     Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be~     beneficial in the elimination of inflammatory mediators and may improve the inflammatory~     status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100~     will improve the inflammatory status of chronic dialysis patients.~   "
151537|NCT01582880|"~     The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A~     (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston~     KPro) in patients with higher risk for corneal melting (keratolysis).~   "
151538|NCT01582867|"~     The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration~     treatment.~   "
151539|NCT01582854|"~     The aim of this trial is to provide evidence that Actovegin has a symptomatic effect in~     subjects with post stroke cognitive impairment (PSCI) during a six month treatment period~     compared to subjects administered placebo. Subjects received IV infusions whilst in hospital,~     and tablets once discharged. Subjects were followed up for a further six months after their~     treatment had been stopped to explore if the cognitive symptoms of the subjects treated with~     Actovegin showed sustained improvement. The trial also explored the possible prevention of~     dementia with Actovegin in patients who had suffered a recent ischaemic stroke, as well as~     the effect of Actovegin on other stroke outcomes. Safety information on Actovegin was~     collected.~   "
151540|NCT01582841|"~     The investigators research mobilizes the resources of an integrated health-delivery system~     with extensive electronic clinical data to implement and evaluate a new strategy to maximize~     screening of Colorectal Cancer (CRC) patients for Lynch Syndrome.~   "
152101|NCT01575483|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Onglyza® so that the regulatory authority can manage the marketing approval~     properly.~   "
151543|NCT01582802|"~     Multiple births in the United States are rapidly increasing in large part due to assisted~     reproductive technologies. Recent data indicate that multiple births now comprise 3-4.5% of~     all births in the United States. Pregnant women are at risk for iron (Fe) deficiency anemia~     yet there are virtually no data on Fe status in women carrying multiples and current~     recommendations do not necessitate Fe screening among this high risk group. Maternal anemia~     is known to increase the risk of adverse birth outcomes including preterm birth and low birth~     weight. Moreover, the developing brain is increasingly recognized to be susceptible to Fe~     insufficiency in utero and growing data support that suboptimal Fe stores at birth are~     associated with long-term irreversible cognitive deficits in the offspring. To address these~     gaps in knowledge the investigators will monitor weight gain, hematological measures, Fe~     status indicators and serum hepcidin across pregnancy in approximately 120 women carrying~     twins and triplets. Determinants of maternal anemia will be identified. Neonatal~     hematological measures will be assessed in cord blood from each neonate at birth for~     assessment of hematological measures, Fe status and hepcidin. Determinants of neonatal anemia~     will be identified. Inflammatory markers will be measured in all blood samples and related to~     outcomes. Stable iron isotopes will be given to a subset of women to assess maternal Fe~     absorption and fetal Fe uptake.~   "
151544|NCT01582789|"~     The purpose of this study is to obtain objective and subjective clinical data to compare the~     performance of two soft contact lenses.~   "
151545|NCT01582776|"~     This study is to determine first the appropriate dose of lenalidomide to administer in~     combination with fixed doses of obinutuzumab in relapsed/refractory follicular lymphoma~     patients.~      In a second step, this study aims to determine the efficacy of this combination in 3 separate~     populations: relapsed/refractory aggressive lymphoma (diffuse large B-cell lymphoma and~     mantle cell lymphoma: cohort 1), relapsed/refractory follicular lymphoma (cohort 2) and~     previously untreated follicular lymphoma (cohorts 3 and 4).~   "
151546|NCT01582763|"~     International GBS Outcome Study (IGOS) is a study conducted by the members of the~     Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course~     and outcome in Guillain-Barré syndrome (GBS).~      The IGOS aims to identify clinical and biological determinants and predictors of disease~     course and outcome in individual patients with Guillain-Barré syndrome, as early as possible~     after onset of disease.~   "
151547|NCT01582750|"~     The purpose of this study is to determine the role of endoscopic ultrasound measurement of~     the primary tumor maximum diameter changes in absolute / relative values in predicting the~     tumor regression after concurrent chemoradiotherapy for rectal cancer.~   "
151548|NCT01582737|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Xarelto for SPAF.~      The objective of this study is to assess safety and effectiveness of Xarelto using in real~     clinical practice.~      A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational~     period. An annual follow-up survey will be conducted for 5 years at the longest after~     standard observational period.~   "
151549|NCT01582724|"~     The aim of the study is to evaluate the effectiveness of additional self-care acupressure in~     women with menstrual pain compared to usual care alone.~   "
151550|NCT01582711|"~     The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT,~     SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients~     diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The~     primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly~     rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to~     self-administered therapy (SAT). The secondary objectives:~        -  To compare the treatment completion rates between participants randomized to SAT without~          reminders versus SAT with weekly SMS reminders~        -  To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among~          participants who complete treatment and those who discontinue therapy prior to~          completion.~        -  To determine the availability and acceptability of using SMS reminders among all~          patients consenting to participate in the study.~        -  To determine the toxicity and tolerability by comparing the rates of any drug-related~          grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined~          and individually)~        -  To compare the frequency, timing, and causes for failure to complete treatment between~          the DOT arm and the SAT arms~        -  To collect patient-specific cost data related to the 3 treatment arms~        -  To describe the pattern of antituberculosis drug resistance among Mycobacterium~          tuberculosis strains cultured from participants who develop active TB.~   "
151551|NCT01582698|"~     The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after~     the first booster TBE vaccination with FSME-IMMUN 0.5ml.~   "
151552|NCT01582685|"~     The investigators hypothesize that exercise in postmenopausal breast cancer survivors will~     result in an increase in the plasma concentrations of angiostatic factors and a decrease in~     the plasma concentrations of angiogenic factors. Exercise is expected to result in a~     circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer~     tumor, growth of microscopic residual disease after breast cancer resection, decreases rates~     of local-regional recurrence, decreases rates of distant recurrence, and increases survival.~   "
151553|NCT01582672|"~     This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal~     Cell Carcinoma. The purpose of this study is to determine whether there is an overall~     survival (OS) benefit between subjects treated with AGS-003 in combination with standard~     treatment versus subjects treated with standard treatment alone.~   "
151579|NCT01582321|"~     Inflammation is a key initiating and damaging factor in many illnesses including infection,~     arthritis and cancer but also of particular relevance to this study in diseases of the heart~     and blood vessels (i.e. cardiovascular disease). Much evidence now exists demonstrating that~     male sex increases ones risk of cardiovascular disease. More recent evidence demonstrates~     that inflammatory responses in females appear to dampened in comparison to age matched males.~     Since inflammation is thought to be a key initiating phenomenon in many cardiovascular~     disease states the investigators will examine the differences in acute inflammatory responses~     between the sexes in healthy volunteers and the impact this has on the function of blood~     vessels.~   "
151556|NCT01582633|"~     This study will evaluate the immunological response and the safety profiles of seasonal,~     inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 pandemic~     influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full~     dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group~     with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60~     years old.~      Reduced doses into the skin will be delivered by an investigational intradermal model of a~     licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA~     manufactured by D'Antonio Consultants International, Inc. DSJIs avoid the drawbacks and~     dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also~     rapid and simple and overcomes the difficulty and patient discomfort of the traditional~     Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin~     testing.~      Participants will be assessed for local and systemic adverse events by clinical observation~     immediately after injection and then upon return on day 21 after each injection. In addition,~     investigators will call participants by telephone on days 2 and 7 days to collect information~     local and systemic side effects.~      Serum will be collected on day 21 after each injection, and assayed for hemagglutination~     inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto de~     Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant.~     Information about the adverse events would be collected on days 1, 3 and 7 after dose~     delivery. The investigators assessing adverse reactions will be blinded to the study arm to~     which each subject was allocated.~      The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each~     dose in accordance with international parameters which include: seroconversion or significant~     title increase (SCR), the frequencies by study arm of seroprotection defined as a~     post-vaccination titer of >40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs) of~     post-vaccination sera.~   "
151557|NCT01582620|"~     The purpose is to study the clinical, technological and organizational impacts of a~     telestroke service between Nordlandssykehuset, Bodø, and two small rural hospitals in Lofoten~     and Vesterålen. The stroke specialist in Bodø will examine the patient in cooperation with~     the doctor at the local hospital through video- and sound communication. Radiology images are~     transmitted using the RIS/PACS system.~      Telestroke consultations may be useful to assess whether the patient needs thrombolysis~     medication, and also whether there is a need for more advanced specialist neurological or~     neurosurgical treatment, supporting quick triaging and transfer to the appropriate unit.~      The study design is a multi-method approach using before-and-after hospital information data~     as well as registration forms monitoring patient outcome and pathways. The research questions~     will be approached from medical, organisational and technological perspectives.~      A telestroke service in North Norway is expected to face other challenges than those reported~     internationally: In Nordlandssykehuset, as in Helse Nord in general, the number of cases is~     low, clinicians have high turnover, technical support is not available 24/7 and severe~     weather conditions and long distances might add to the transport time.~      Primary hypothesis: The use of telestroke leads to faster and more accurate diagnosis and~     proper treatment~      Secondary hypothesis: Telestroke leads to improved overall patient treatment~   "
151558|NCT01582607|"~     The purpose of the investigators study is to compare the clinical effects and side-effects of~     these three local anaesthetics as sole agents or with the supplementation with fentanyl for~     c-section, especially when administered in doses achieving approximately an ED 50.~   "
151559|NCT01582594|"~     To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test~     using known anti-HCV seropositive and seronegative specimens.~      Registration for license application~   "
151560|NCT01582581|"~     The purpose of this study is to evaluate a computer-guided, telephone-based therapy for~     adolescent depression, delivered in a pediatric primary setting in the community.~   "
151561|NCT01582568|"~     The primary objective of this study is to assess perianal and perirectal fistula healing~     (complete closure) based on endoscopic ultrasound (EUS) evaluation at 3 months and by PDAI~     (Pouchitis Disease Activity Index) and Fistula Drainage assessment by 6 months, showing no~     fistula (new or recurrence) in treatment of Crohn's' disease patient with Certolizumab~     (Cimzia).~   "
151562|NCT01582555|"~     Nasal irrigation techniques have been used for many years and been shown to improve symptoms~     of rhinosinusitis. Although there is a wealth of literature available, establishing treatment~     protocols can be difficult because of the great variability in recommended composition~     (seawater or hypertonic or isotonic saline with or without additives) and irrigation~     technique (variations in pressure and volume). Nasal irrigation is also used in many centers~     as part of postoperative treatment protocols and in particular has been recommended following~     endoscopic sinus surgery (ESS). Nasal crusting and thick nasal discharge have a negative~     impact on these patients quality of life (QOL). At the time of our study, there are no~     studies comparing irrigation with mucolysis with saline irrigation following ESS. The~     investigators aimed to assess whether mucolysis is effective at improving patients QOL and~     reducing postoperative signs as assessed endoscopically.~   "
151563|NCT01582542|"~     The purpose of this study is to prospectively assess whether Desmopressin, given for a period~     of month to patients after radical cystectomy with orthotopic bladder reconstruction,~     improves and lowers the rate of nocturnal enuresis.~   "
151564|NCT01582529|"~     The purpose of this study is to learn about the relationship between family factors and~     developmental and psychosocial outcomes in children with congenital heart disease at 6 years~     of age. A secondary purpose is to learn more about psychosocial outcomes in children with~     congenital heart disease and their families over time.~      About 250 mothers and fathers at 15 medical centers will take part in this study; 35 will be~     from Children's Hospital of Wisconsin.~   "
151580|NCT01582308|"~     A five-period crossover study to assess and compare the trough dipeptidyl peptidase IV~     (DPP-4) inhibition at 24-hours following the final morning dose for sitagliptin, saxagliptin~     and vildagliptin after 5 days of once daily dosing and vildagliptin after 5 days of twice~     daily dosing in participants with T2DM. The primary hypothesis is that following multiple~     daily dose administration to achieve steady-state drug concentrations, 100-mg sitagliptin~     will demonstrate greater DPP-4 inhibition at 24-hours after the final dose compared to 5-mg~     saxagliptin and 50-mg vildagliptin (once daily administration) in participants with T2DM.~     Each participant will receive all 5 treatments in randomized order. There will be a washout~     interval of at least 10 days between the last dose of study drug in one period and the first~     dose of study drug in the following period.~   "
151671|NCT01581112|"~     The malodour generation of a person's armpit/foot is caused by the bacteria thriving on that~     armpit/foot. In order to alter or reduce once bad body odour or foot odour, the living~     microbial community on the foot/armpit of a non-malodorous person will be transmitted (or up~     scaled and transmitted) to the foot/armpit of a malodorous person. The odour is evaluated by~     a trained smelling panel, the bacteria living on the armpit/foot is examined by means of~     molecular techniques. The microbial transplantation and its follow-up happens under the~     supervision of a doctor.~   "
151565|NCT01582516|"~     In the Netherlands a 2 center investigator-driven phase I/II clinical trial is initiated in~     June 2010 testing the oncolytic adenovirus Delta24-RGD to treat glioblastoma patients. The~     virus is administrated using convection-enhanced delivery by 4 catheters as delivery~     technique, targeting solid tumor as well as infiltrated tumor cells within the peri-tumoral~     brain. Patients will be enrolled in cohorts of 3 per dose-level. The dose levels to be~     explored are: 10^7, 10^8, 10^9, 10^10, 3*10^10 and 10^11 viral particles (vp). Once the MTD~     has been determined, or the study has reached the highest dose cohort, a further 6 or 9~     patients will be enrolled at the MTD and evaluated for safety and preliminary signs of~     efficacy, such that in total at least 12 patients have received the MTD.~      The primary objective is to determine the safety and tolerability of Delta-24-RGD~     administered by CED to the tumor and the surrounding infiltrated brain in patients with~     recurrent GBM. Secondary objectives are to determine the Progression Free Survival (PFS),~     Overall Survival (OS), and tumor response rate in patients with recurring tumors amenable for~     surgical resection and treated at the MTD.~      Cerebrospinal fluid as well as brain interstitial fluid by microdialysis next to the~     routinely collected samples of blood at various timepoints before, during and after virus~     infusion. Various neurodegenerative biomarkers as well as markers of immune response will be~     assessed in these samples.~      Furthermore extensive sampling and PCR analyses will be performed to evaluate distribution~     and shedding of the virus.~   "
151566|NCT01582503|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety~     of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately~     controlled on chronic therapy with high dose inhaled corticosteroids and a second controller~     medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of~     either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual~     asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with~     a 48-week follow-up.~   "
151567|NCT01582490|"~     This is a Phase 4, prospective, open-label, non-randomized, sequential study with two~     treatment groups differing only in the technique used for EXPAREL administration~     (instillation or infiltration).~   "
151568|NCT01582477|"~     The purpose of the study is to assess the safety and efficacy of EXPAREL when administered~     via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical~     analgesia in men undergoing robot-assisted laparoscopic prostatectomy.~   "
151569|NCT01582464|"~     The goal of this phase of the project is to identify the elements of the Theory of Planned~     Behavior (TPB) that should be targeted to provide the most influence on older adults'~     behavior (or other stakeholders) to purchase and wear protective headwear. The investigators~     also intend to determine the format of communication (social marketing/academic detailing)~     that is most influential for different key stakeholder groups. The TPB has been useful in~     understanding behavior change related to exercise and adaptive equipment use (such as grab~     bars, canes, hip protectors); in understanding how a person's attitudes, subjective/social~     norms and perceived behavioral control inform the development of intention that leads to~     behavior change.~   "
151570|NCT01582451|"~     The purpose of this study is to compare LY2605541 and insulin glargine using the following~     measures after participants have been treated for 26 weeks:~        -  Change in participants' overall blood sugar control~        -  The rate of night time low blood sugar episodes~        -  The number of participants that reach blood sugar targets without low blood sugar~          episodes at night~        -  The rate of low blood sugar episodes reported over a 24-hour period~   "
151571|NCT01582438|"~     The purpose of this study is to provide sildenafil therapy to subjects who have completed the~     A1481156 study for the treatment of Pulmonary Arterial Hypertension (PAH) in India and are~     judged by the Investigator to derive clinical benefit from continued treatment with~     sildenafil citrate. Sildenafil citrate will be supplied for the treatment of Pulmonary~     Arterial Hypertension (PAH) until the subject continues to derive benefits from the~     treatment. The treating physicians (and the sponsor) will be responsible for reporting~     serious adverse events.~   "
151572|NCT01582425|"~     The primary purpose of this study is to assess the effect of multiple doses of isavuconazole~     on the pharmacokinetics (PK) of methadone after single dose administration. The secondary~     purpose is to assess the safety and tolerability of isavuconazole alone and in combination~     with methadone.~   "
151573|NCT01582412|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of digoxin in healthy adult subjects.~   "
151574|NCT01582399|"~     The objective of this study is to assess levels of ASKP1240 in the blood after a single dose~     given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how~     the drug behaves inside the body and how it is eliminated from the body by looking at the~     pharmacokinetics of ASP1240.~      In addition, the study will determine the effects of ASKP1240 on the body by looking at its~     pharmacodynamics (PD) and at the safety and tolerability of ASKP1240 when given by IV or as~     SC injection.~   "
151575|NCT01582373|"~     The current pilot study aims to assess the feasibility and preliminary efficacy of a novel,~     12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners.~   "
151576|NCT01582360|"~     The main purpose of the study is to examine if changes in pharmacokinetics of important~     antiinfectives in Critically Ill patients in need of continuous renal replacement therapy~     (CRRT), causes inadequate concentrations in plasma.~      The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of~     filter, filter lifetime etc.~      Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in~     critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives~     may contribute to increased mortality in this group.~   "
151577|NCT01582347|"~     This study is designed to determine if opioid dependent subjects who are already receiving~     Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will~     continue their pre-study prescribed dosage of Subutex and/or Suboxone~   "
151578|NCT01582334|"~     This is an Argentinian, Multicentre, Observational Study to evaluate Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth~     hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
151581|NCT01582295|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it. It also~     means the FDA has not approved the drug for your type of cancer.~      Cabozantanib (XL184) is a new drug that is being developed to treat cancer. The study drug~     cabozantinib works by inhibiting several different proteins which are believed to be involved~     in multiple myeloma growth, its ability to spread, and its ability to form new blood vessels.~     This drug has been used in other research studies and information from those other research~     studies suggests that this drug may help to slow or stop disease growth to bones and prevent~     cancer growth.~      In this research study, we are looking to see how effective cabozantanib is in slowing or~     stopping disease growth to the bones as well as preventing your cancer from worsening. We are~     also looking for the highest dose of cabozantinib that can be given safely to patients who~     have multiple myeloma with bone disease.~   "
151582|NCT01582282|"~     A double-blind, randomized, placebo-controlled, multi-dose clinical study consisting of 2~     phases; 1) an 8-week lead-in period during which patients followed a diet judged to be within~     the acceptable guidelines of the ADA, and 2) a 12-week treatment period, at the beginning of~     which, Subjects are randomly assigned to 1 of the 3 treatment groups: placebo, 3.4 g psyllium~     BID for a total of 6.8 g/day (10.4g Metamucil) or 6.8g psyllium BID for a total of 13.6 g/day~     (20.8g Metamucil). For 12 weeks, Subjects took Metamucil or the fiber-free placebo BID, just~     prior to breakfast and dinner.~      Patients visited the clinic 10 times during the 20-week period at Screening, Weeks -8, -6,~     -4, 0, Day 3, and Weeks 2, 4, 8 and 12, fasting at least 12 hours prior to each visit where a~     blood sample was taken (all visits except Week -6 and Day 3) for analysis of fasting serum~     glucose and lipid levels, and HbA1c. Clinical chemistry, hematology and urinalysis were done~     at Weeks -8, 0 and 12. The completed 7-day food diaries were reviewed by the study dietician~     at each visit and discussed with the patient to ensure compliance with the recommended diet~     and the patients' body weights were recorded~   "
151583|NCT01582269|"~     The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299~     plus lomustine therapy or lomustine plus placebo can help participants with brain cancer~   "
151584|NCT01582256|"~     The study aims to investigate whether neuropsychological function (particularly cognitive~     flexibility and executive function), functional (assessed by resting functional MRI, rfMRI)~     and structural connectivity (assessed by DSI), and electrophysiological function (assessed by~     event-related potential [ERP]: mismatch negativity, MMN and P50) can be effective cognitive~     endophenotypes (biomarkers) for Autism spectrum disorders (ASD).~   "
151585|NCT01582243|"~     This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2~     diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment~   "
151586|NCT01582230|"~     The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid~     add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus~     inadequately controlled on insulin with or without metformin treatment.~   "
151587|NCT01582217|"~     The purpose of this study is to assess the the 1-year rates of ischemic and bleeding~     complications in patients whose dual antiplatelet therapy regimen post-PCI has been~     determined with the use of a clinical algorithm that includes both clinical risks and~     platelet reactivity while on chronic clopidogrel therapy.~   "
151588|NCT01582204|"~     Usually, doctors monitor kidney cancer with CT scans to measure the size of tumors.~     Sometimes, even when a drug is working, it can take several months before the effects are~     seen on a regular CT scan. The purpose of this study is to see if a new kind of scan, called~     124I-cG250 PET/CT, can determine response to sunitinib or pazopanib earlier than a regular CT~     scan.~      Research has shown that certain proteins in the blood, called antibodies, can attach~     themselves to cancer cells without binding to normal cells. In this study, an antibody is~     used called chimeric G250 (cG250) that is attached to a radioactive isotope. The radioactive~     isotope in this study is Iodine-124 (124I). If cG250 has attached to tumors in the body, 124I~     shows up on the PET scan.~   "
151589|NCT01582191|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of vandetanib and everolimus that can be given to patients with advanced cancer.~     The effects of the study drugs at different dose levels and the safety of the study drugs~     will also be studied.~      Vandetanib and everolimus are both designed to harm cancer cells, stopping their growth. This~     may stop or slow the growth or spread of cancer cells.~   "
151590|NCT01582178|"~     Water immersion insertion has been documented to decrease procedure-related discomfort during~     colonoscopy. There was used warm water infusion for colonoscope insertion in most of the~     water immersion colonoscopy trials.~      The investigators have been using room temperature water (20-24°C) for water immersion and~     the investigators did not notice any drawback of it. In our opinion, it is simpler and~     cheaper option for water immersion colonoscopy and proof of its efficacy and safety could~     support the use of water immersion technique in routine practice.~      The primary endpoint is cecal intubation time and the investigators suppose that the use of~     warm water infusion does not shorten it significantly. Patient comfort during colonoscope~     insertion, water consumption, length of the scope while reaching the cecum, need for external~     compression, need for positioning of the patient and endoscopist´s difficulty with~     colonoscopy will be also assessed.~   "
151591|NCT01582165|"~     Female patients presenting with persistent chest pain despite no obstructive coronary artery~     disease have impaired prognosis. Stress tests are often positive or inconclusive. As much as~     20% of women with chest pain and minimal angiographic CAD have evidence of myocardial~     ischemia, suggesting impaired coronary microcirculation. The index of microvascular~     resistance (IMR) is a method for indirectly investigating microvascular function in the~     cardiac catheterization laboratory.~      66 female patients, age 30-70 years, with chest pain and normal or near normal coronary~     angiograms will be included. After coronary physiologic evaluation, patients will be~     randomized in a double blind study to rosuvastatin 20 mg/day or matching placebo tablets for~     altogether 6 months.~      The investigators hypothesize that:~        1. A substantial number of women with chest pain and normal or minimal pathology on~          angiograms have microvascular dysfunction defined by a raised IMR.~        2. Statins, based on its pleiotropic action will improve endothelial function and thereby~          IMR.~   "
151592|NCT01582152|"~     The goal of Part I of this clinical research study is to find the highest tolerable dose of~     TPI 287 that can be given with bevacizumab to patients with glioblastoma. The goal of Part II~     is to learn if TPI 287 when given with bevacizumab can help to control glioblastoma better~     than when bevacizumab is given alone. The safety of the drug combination will also be~     studied.~      TPI 287 is similar to a type of chemotherapy drug called a taxane and is designed to block a~     protein (tubulin) that helps the cancer cells divide. By blocking the tubulin, the drug may~     be able to cause the cancer cells to shrink or stop growing.~      Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the~     growth of blood vessels.~   "
151593|NCT01582139|"~     The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell~     Phone + Closed Loop Control) can successfully control blood sugar in people with type 1~     diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be~     studying to see if information about heart rate can help the AP Platform reduce hypoglycemia~     related to exercise.~   "
151594|NCT01582126|"~     People with multiple sclerosis (MS) often have affected balance capacity and an increased~     risk for falls. A risk factor for falls are activities requiring dual attention. Another~     factor leading to reduced balance capacity is trunk stability, and decreased trunk stability~     has been seen in people with MS compared to healthy controls. Earlier studies using core~     stability exercises have shown positive effects on balance, compared to no training. In~     Sweden, physical therapy for people with MS has often included group training. However,~     evidence for this intervention is scarce. The aim of this study is therefore to investigate~     balance training in group. The balance training includes core stability exercises and dual~     attention activities. A multi-centre study is planned with a waiting-list design.~     Participants are randomised to either exercise group with early start or with late start. The~     group balance training includes training 60 minutes 2 times per week for 7 weeks.~   "
151595|NCT01582113|"~     To determine the functional effects of Citicoline, a natural supplement, when administered~     for a duration of four weeks (28 days) to non-psychiatric adolescent male participants. The~     investigators hypothesize that citicoline will provide cognitive benefits to this population~     after 28 days of supplementation.~   "
151596|NCT01582100|"~     Gastroesophageal reflux disease (GERD) is a highly prevalent condition that is frequently~     encountered in the health care setting. It affects roughly 40% of Americans monthly and 10%~     weekly. Of those with GERD, there exists a cohort that experience nausea with or without~     vomiting that is unresponsive to PPI's and anti-emetics. For these patients, treatment~     options are limited and these symptoms may substantially alter their quality of life. New and~     novel therapies emerging include neuromodulation devices that may affect the central pathways~     leading to these symptoms. Of these, the Reletex band has been tested and proven efficacious~     in the treatment of nausea and vomiting associated with pregnancy, chemotherapy, and surgery,~     in addition to standard anti-nausea medications. The investigators propose that through a~     similar mechanism, this device as an adjunct to PPI's and anti-emetics will reduce~     GERD-associated the nausea with or without vomiting, and by so doing, improve the quality of~     lives in this patient population.~   "
151597|NCT01582087|"~     The purpose of this study is to understand mechanisms associated with the development of coma~     during hepatic failure. As of today, those mechanisms are not understood and it is difficult~     to intervene and prevent coma development which is often associated with mortality.~     Understanding the mechanism involved, may allow us to prevent coma and develop new therapies~     to treat this disease.~   "
151598|NCT01582074|"~     Background:~      - Studies have shown that changes in breast density (the amount of white area on a woman's~     mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way~     to measure breast density repeatedly over time. Researchers want to test whether ultrasound~     tomography scans can show changes in breast density. To examine these changes, healthy~     volunteers with no history of breast cancer and women who are taking tamoxifen will have~     ultrasound tomography scans.~      Objectives:~      - To test whether ultrasound tomography scans can show changes in breast density related to~     tamoxifen exposure.~      Eligibility:~      - Women between 30 and 70 years of age who are (a) taking tamoxifen or (b) healthy volunteers~     who have never had breast cancer.~      Design:~        -  All participants will have a screening visit. Healthy volunteers will have one~          additional study visit; women taking tamoxifen will have three additional study visits.~        -  All participants will be screened with a physical exam and medical history. They will~          also give blood and saliva samples. This visit will also include an initial ultrasound~          tomography breast scan.~        -  For the healthy volunteers:~        -  At the study visit (12 months after the screening visit), participants will have a short~          interview and be weighed. They will also have an ultrasound tomography breast scan and~          provide a blood sample.~        -  For the women taking tamoxifen:~        -  At the second and third visits (1 to 3 months and 3 to 6 months after starting~          tamoxifen), participants will have a short interview. They will also be weighed and have~          an ultrasound tomography breast scan.~        -  At the fourth visit (12 months after starting tamoxifen), participants will have a short~          interview, weight measurement, and the ultrasound tomography breast scan, and will also~          provide a blood sample.~        -  All participants may be followed for up to 5 years after their final study visit.~   "
151599|NCT01582061|"~     This study provided access to pasireotide sc in patients with Cushing's disease.and provided~     additional information for safety and efficacy of pasireotide s.c.~   "
151600|NCT01582048|"~     Feasibility and toxicity of peritransplantation immunosuppression with ATG, sirolimus,~     mycophenolate mofetil and rituximab in patients receiving mismatched allogeneic HCT after a~     reduced intensity conditioning regimen with fludarabine/treosulfan~   "
151601|NCT01582035|"~     The purpose of this study is to assess safety, tolerability, pharmacokinetics (how the drug~     is absorbed into the bloodstream) and antiviral activity of repeated doses of TMC647055 given~     in combination with telaprevir in HCV infected patients. TMC647055 is being investigated for~     the treatment of hepatitis C infection. Telaprevir has recently been approved in the USA and~     in Europe for the treatment of chronic hepatitis C infected patients.~   "
151602|NCT01582022|"~     Research Methodology:~      It will be a prospective, randomized, placebo-controlled, single-blind, intra-individual~     study in which one tonsillar fossa will be the tested side, and the other fossa will be the~     control. And the tested side will be packed with bupivacaine for five minutes. In the other~     hand, the controlled side will be packed for five minutes with gauze soaked in normal saline.~     The selection of the tested side and controlled side will be randomized based on the last~     digit in the medical record number (i.e. if the last digit is even then the tested side is~     the right and if the last digit is odd then the tested side is the left). Pain evaluation~     will be by visual analog scale and it will be in frequency of 2, 4, 6, 8, 12, 24 hours~     post-op.~   "
151603|NCT01582009|"~     RATIONALE: Panobinostat and everolimus may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth or by blocking blood flow to the tumor.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving~     panobinostat together with everolimus and to see how well they work in treating patients with~     metastatic or unresectable renal cell cancer that does not respond to treatment with~     sunitinib malate or sorafenib tosylate~   "
151604|NCT01581996|"~     Positive phosphorus balance and hyperphosphatemia (increased serum phosphorus levels) are~     very common complications of people with advanced chronic kidney disease (i.e., stage 5 CKD),~     including chronic dialysis patients, and are associated with severe morbidity and increased~     mortality. Despite attempts to control serum phosphorus with dietary phosphorus restriction~     and the use of medicines that bind phosphorus in the gastrointestinal tract so that the~     phosphorus cannot be absorbed into the body( also called phosphate binders), chronic dialysis~     patients frequently remain hyperphosphatemic, particularly at the time when they commence~     each of their regular dialysis treatments.~      Fosrenol (lanthanum carbonate, manufactured by Shire Pharmaceuticals) is a gastrointestinal~     phosphate binder that appears to have the advantages of being safe, well tolerated and~     effective at binding phosphate. There are limited data on the magnitude of binding of~     phosphorus by Fosrenol in the human gastrointestinal tract of patients with chronic kidney~     disease.~      The specific aims for this proposal are as follows:~        1. To quantify, under precisely controlled metabolic balance conditions, the increase in~          fecal excretion of dietary phosphorus that occurs when patients undergoing chronic~          peritoneal dialysis (CPD) ingest Fosrenol (lanthanum carbonate).~        2. To examine a dose response relationship between Fosrenol treatment and fecal phosphorus~          excretion. The investigators will examine in CPD patients ingesting a constant~          phosphorus intake, how much additional phosphorus is excreted in the feces at three~          different dose levels of Fosrenol, 1.5, 3.0, and 4.5 g/day.~        3. To examine how increased fecal phosphorus losses and more negative phosphorus balance~          caused by Fosrenol intake affects serum phosphorus and such hormonal regulators of~          phosphorus metabolism as serum parathyroid hormone (PTH), fibroblast growth factor-23,~          25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3) and~          fetuin-A.~        4. To assess whether there is any effect of Fosrenol and increased intestinal phosphate~          binding on protein-nitrogen balance.~   "
151605|NCT01581983|"~     The purpose of this study is to assess feasibility of an internet and individual format of~     mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression~     symptoms~   "
151606|NCT01581970|"~     This is a feasibility study to assess the effectiveness of cetuximab when administered with~     low dose oral cyclophosphamide. Patients with metastatic squamous cell cancer of head and~     neck who have progressed on first line chemotherapy other than a cetuximab containing regimen~     will be treated with standard of care weekly cetuximab and twice daily low dose oral~     cyclophosphamide for 12 weeks.~   "
151607|NCT01581957|"~     Specifically designed enteral formulations may improve the gastrointestinal tolerance during~     early enteral nutrition in the critically ill patient.~      This pilot trial will permit testing the design of the full-scale study providing valuable~     data on the expected effect of the formulation, the variability, thus helping to better~     estimate the required sample size.~   "
151608|NCT01581944|"~     Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are~     benign growth in the womb or uterus and in order to preserve the fertility of women they,~     require an operation called myomectomy or shelling out of the fibroid. This procedure can be~     associated with large blood loss.~      In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to~     the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current~     gynaecological practice to treat women with heavy periods.~      In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin~     agonist prior to their operation and no treatment. The intraoperative blood loss was~     measured. The study hypothesis: To determine whether administration of gonadotropin releasing~     hormone agonist prior to myomectomy reduces intraoperative blood loss.~   "
151609|NCT01581931|"~     To establish bioequivalence (BE) under fed conditions between metformin in~     linagliptin/metformin fixed dose combination tablet and metformin reference product~     administered in free combination togther with linagliptin~   "
151610|NCT01581918|"~     Nausea and vomiting are common problems for cancer patients. Half of them will experience~     these symptoms during the course of their disease, either because of the cancer itself or~     because of their treatment1. They are ranked by patients as two of the worst adverse effects~     of cancer chemotherapy and cause a negative impact on patient's functional, emotional, social~     and nutritional status and quality of life2,3.~      Nowadays, a wide variety of antiemetic agents are available for the prevention and treatment~     of CINV. In this scenario, three classes play a critical role: Selective 5-HT3-receptor~     antagonists - approved for clinical practice in early 1990s, revolutionized the management of~     CINV representing the most effective agents in the treatment of acute emesis -,~     Corticosteroids - with unknown mechanism of action, effective when administered as single~     agents in patients receiving chemotherapy of low emetic potential but are most beneficial~     when used in combination with other antiemetic agents, potentiating their anti-emetic~     efficacy in both acute and delayed symptoms - and neurokinin 1 receptor antagonist - also~     effective against both acute and delayed emesis, but restricted utility in daily clinical~     practice because of its high cost.~   "
151611|NCT01581905|"~     Approximately 600,000 women undergo hysterectomy each year in the United States, of which 12%~     are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine~     leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total laparoscopic~     hysterectomy was performed by Reich et al in 1988. Many studies have proven that laparoscopic~     hysterectomy is associated with lower preoperative morbidity, shorter hospital stay, and~     shorter recovery times than abdominal hysterectomy. The literature has also shown the~     complication rates for laparoscopic cases are similar to open procedures in the hands of an~     experienced laparoscopic surgeon. The American Congress of Obstetricians and Gynecologists~     Committee on Gynecologic Practice state that laparoscopic hysterectomy is an alternative to~     abdominal hysterectomy for those patients in whom vaginal hysterectomy is not indicated or~     feasible. The ACOG Committee on Gynecologic Practice site multiple advantages of laparoscopic~     hysterectomy to abdominal hysterectomy including faster recovery, shorter hospital stay, less~     blood loss, and fewer abdominal wall/wound infections. Despite the recommendations of ACOG~     for a more minimally invasive approach, 66% of all hysterectomies are performed abdominally.~     Key reasons for the lag in utilization of laparoscopic techniques are the technical obstacles~     of performing minimally invasive hysterectomies. Robotic technology has emerged as a means to~     decrease the learning curve and increase the availability of minimally invasive surgery to~     patients. A current review of the literature reveals no randomized trials evaluating the~     efficacy of conventional laparoscopic hysterectomy vs. robot-assisted laparoscopic~     hysterectomy. The investigator's aim is to address this void.~      The primary objective of this study is to determine whether Robot-Assisted Laparoscopic~     Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to~     operative time, blood loss, and hospital stay. The investigator's secondary objective was to~     assess the cost, morbidity, and mortality of each procedure.~   "
151612|NCT01581892|"~     The aim of the study is to determine the safety and feasibility of autologous mononuclear~     stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.~   "
151613|NCT01581879|"~     The objective of this study is to compare the rate and extent of absorption of ziprasidone 20~     mg capsules versus Geodon 20 mg capsules under fed conditions.~   "
151614|NCT01581866|"~     The objective of this study is to compare the rate and extent of absorption of ziprasidone 20~     mg capsules versus Geodon 20 mg capsules under fasting conditions.~   "
151615|NCT01581853|"~     Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while~     Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago.~     The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200~     mg monotherapy once a day.~   "
151616|NCT01581840|"~     Treatment is based on radiochemotherapy for locally advanced tumours. The objective of~     treatment is to provide a cure without resorting to abdominoperineal amputation, while~     preserving sphincter function.~      The prognosis is mainly related to tumour size and lymph node invasion. The large majority of~     patients do not show any spread remote from the tumour at the time of diagnosis (2).~      Recurrences are mainly of a local/regional nature and require abdominoperineal amputation.~     This type of intervention is not always possible or complete, which then gives rise to the~     particularly distressing risk of local progression, with survival at 3 years of approximately~     30% (3).~      It is therefore very important to achieve a complete and permanent tumour response from~     initial treatment with radiochemotherapy.~      Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in~     ENT cancer was able to increase recurrence-free survival and overall survival in these~     patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR~     antibodies in epidermoid cancer of the anus.~   "
151617|NCT01581827|"~     Heart failure (when the heart does not pump as well as it used to) is a medical condition~     which reduces the quality of life for the sufferers. Approximately 10% of people in western~     societies aged over 75 develop heart failure. There has been a shift towards prevention of~     this disease and it is hoped that BNP (brain natriuretic peptides) and NT-proBNP (N-terminal~     proBNP) will prove to be useful indicators of those at greatest risk. The current study~     therefore plans to follow up the 3500 participants at risk of heart failure from the original~     SCREEN-HF study.~      Participants who are willing to participate will be contacted annually. They will undergo a~     short physical exam, will be asked to complete a Quality of Life questionnaire and will have~     a blood sample taken. At the end of the study participants will also have an ECG and an~     echocardiogram.~   "
151618|NCT01581814|"~     To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin~     alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS~     patients~   "
151619|NCT01581801|"~     Bariatric surgery has long been recognized as an effective treatment for grade 3 or grade 2~     obesity associated with complications. Among the bariatric surgical procedures, roux-en-y~     gastric bypass (RYGB) was shown to account for 41% of all bariatric operations at least in~     the United Sates. Sleeve gastrectomy (SG), that was conceived as the first step before~     performing a RYGB or a biliopancreatic diversion with duodenal switch in patients who were~     super-obese, has recently emerged as a new restrictive bariatric procedure.~      Reactive hypoglycemia is a late complication affecting up to 72% of RYGB patients although it~     seems to occur also after SG, in about 3% of the cases. However, until now no prospective~     studies have investigated the incidence of hypoglycemia after RYGB nor randomized studies~     have been undertaken to compare the effect of SG to that of RYGB in terms of incidence of~     hypoglycemic episodes.~      The primary aim of the present study is to conduct a 1-year randomized trial to compare the~     incidence of hypoglycemia after RYGB or SG.~   "
151620|NCT01581788|"~     The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER~     Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in~     healthy, adult, human subjects, under fed conditions and to monitor adverse events and ensure~     the safety of subjects.~   "
151621|NCT01581775|"~     The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER~     Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in~     healthy, adult, human subjects, under fasting conditions and to monitor adverse events and~     ensure the safety of subjects.~   "
151622|NCT01581762|"~     Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an important investigation~     tool to obtain tissue for diagnosis. Nowadays, the performance of EUS-FNA varies with~     accuracy rates ranging from 60% - 100%. Needles with different diameters have been explored~     to retrieve tissue specimens. The diagnostic yields, successful rates and safety profiles are~     similar. It has been suggested that although thinner needles provide less cellular material~     than do larger needles, the specimens from the former are less contaminated by blood, and~     thus easier to interpret. In addition, thinner needles may be easier to use because of~     greater flexibility, particularly for locations requiring important scope bending. As a~     result, a new 22G FNA needle has been designed in order to improve the tissue-sampling rate~     (ECHO-HD-22-C, Cook Endoscopy, USA). There is a reverse bevel at the tip of the new needle~     with promotes collection of core sample by shearing material from target lesion during~     retrograde movement of the needle in the lesion. The feasibility and safety of this newly~     design EUS-FNA needle have been demonstrated in a recent multicenter, pooled, cohort study~     using the 19G version. Successful puncture was technically feasible in 98.2% of cases and the~     overall accuracy of 92.9%. There were no complications related to the technique.~      The aim of this study is to compare the tissue-sampling rate and the diagnostic accuracy rate~     of EUS-FNA between the uses of the convention and newly designed 22-gauge needles.~   "
151623|NCT01581749|"~     The primary safety purpose of this study is to estimate the rates of immediate and long-term~     high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years~     after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate~     cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free~     survival rates with TrueBeam to 5 year biochemical diseases free survival rates with~     dose-escalated external beam radiation therapy.~   "
151624|NCT01581736|"~     This protocol is being conducted to determine the mechanisms responsible for insulin~     resistance, obesity and type 2 diabetes.~   "
151625|NCT01581723|"~     Bladder cancer is a common urological malignant disease. Patients with bladder cancer will~     first be managed with transurethral resection (TUR) of bladder tumor. For many years,~     monopolar transurethral resection of bladder tumor (TURP) has been the gold standard for~     treatment. However, complications including bleeding, bladder perforation and inadequate~     sampling of deep tumor biopsy remain the major concerns. Recently published papers suggested~     that the newer bipolar TUR technology has similar surgical outcomes but less complications~     comparing with monopolar TUR. In this study, investigators will investigate the benefit of~     new technology as compared with conventional monopolar resection on tumor clearance,~     complication and recurrence rates.~   "
151626|NCT01581710|"~     This study aims to identify markers to prove rapid improvement of lung function, airway~     inflammation and bronchodilator response after 2-week LTRA administration.~   "
151627|NCT01581697|"~     Atherosclerosis is the leading cause of death and disability in adults. However,~     investigations suggest that the basic pathology of heart disease as more severe myocardial~     infarction which usually reach mainly middle-aged or above, starts from childhood.~     Hypercholesterolemia is one of the most important risk factors for atherosclerosis in adults~     and children, is associated with early deposition of lipids in the aorta and coronary~     arteries.~      Among other recommendations for prevention and treatment of heart disease and risk factors,~     is the recommendation to encourage the intake of soluble fiber. The oats, a major source of~     soluble fiber, has been recognized as a potential component of the diet to lower blood~     cholesterol levels, this effect is attributed mainly to the beta-glucan, a type of soluble~     fiber present in large quantities in oats. In 1997 the Food and Drug Administration admitted~     that the oat bran, oat flakes and oatmeal may have beneficial effects for health with the~     recommendation of daily intake of 3g of beta-glucan from oats and a food that brings a claim~     for promotion health, must provide, without enrichment, at least 1 gram of beta-glucan per~     serving.~      The objective of this project will be compared by randomized clinical trial, the impact of~     intake of oats, for 8 weeks in the lipid profile of children and adolescents with~     dyslipidemia.~      Will be included in the study 120 volunteers aged between 5 and 16 years who are in~     nutritional monitoring for at least 1 month. The subjects will be randomly divided into 2~     groups, with a control group and another intervention will receive 3 tablespoons of soup~     filled with oat bran, which corresponds to 3g of beta-glucan, along with breakfast, lunch and~     dinner. Patients will be monitored with consultations on the 2nd, 4th and 8th weeks of~     treatment. Blood sample will be performed, to obtain the lipid profile of patients, at the~     beginning and end of the study. To compare the groups are used Student's t and squared chi.~     The alpha of 0.05 is considered critical. The program will be used Statistical Package for~     the Social Sciences (SPSS) version 15.0.~      It is expected a decrease in serum levels of total cholesterol and LDL-c. Thus, living habits~     and healthy alternatives to prevent these risk factors should be done since childhood,~     especially in children who already have cholesterol levels of change.~   "
151628|NCT01581684|"~     The primary objective of the current study is to investigate the safety, tolerability and~     pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of~     single rising doses.~      The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19~     (Cytochrome P450) genotyped extensive metabolisers (EM).~      Another objective is to compare the safety and pharmacokinetic profiles between two different~     groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)~   "
151629|NCT01581671|"~     The purpose of this study is to assess the non-invasive, Peripheral Arterial Tonometry (PAT)~     testing as another way of predicting potential coronary artery blockages in the heart.~   "
151630|NCT01581658|"~     The objective of this study is to assess the effect of the different degrees of renal~     impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral~     administration of high dose BI10773 as a single dose in Japanese patients with type 2~     diabetes mellitus.~   "
151631|NCT01581645|"~     Does use of the Mobilaser reduce freezing of gait (FOG) and stride reduction in patients with~     Parkinson's disease and Parkinsonism.~   "
151632|NCT01581632|"~     The investigators hypothesis is that local activation of the endogenous Lp-PLA2 plays an~     integral role in early atherosclerosis, and contributes to the mechanism of coronary~     endothelial dysfunction and to the structural and mechanical properties that characterize~     plaque vulnerability. Thus, our study will characterize prospectively the correlation between~     the functional and structural vascular wall properties, and the activity of the Lp-PLA2~     pathway.~   "
151633|NCT01581619|"~     Standard therapy for patients with early stage breast cancer consists of surgery to remove~     the cancer followed by radiation therapy. One question regarding radiation therapy for early~     stage breast cancer is whether the entire breast needs to be radiated or only a more limited~     area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the~     whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of~     the breast where the cancer was removed (called the tumor bed).~      The investigators hope the option of PBI will reduce side effects from radiation therapy and~     shorten the radiation treatment process when compared to WBI, since only part of the breast~     is being treated. The investigators also hope that this will make such treatment more~     convenient for breast cancer patients.~      The purpose of the study is to evaluate the the safety of external-beam PBI in selected early~     breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators~     will also evaluate the local control and the cosmetic results.~   "
151634|NCT01581606|"~     Hypothesis:~      The use of teleophthalmology for patient screening will result in more rapid patient access~     for treatment. The use of teleophthalmology to monitor patients with wet AMD post-treatment~     will result in maintenance of good visual outcomes combined with a reduction in patient~     travel and improved patients satisfaction in a cost effective manner.~      Objectives :~      The Evaluation of Teleophthalmology in AMD project objectives are as follows:~        1. To evaluate the efficacy of teleophthalmology in screening patients referred to retina~          specialists for suspected wet AMD.~        2. To compare the time to treatment/retreatment with this program with that of patient's~          entering the system and being followed conventionally to determine the efficacy of~          teleophthalmology to provide rapid entry/re-entry into treatment programs.~        3. To determine the efficacy of teleophthalmology in monitoring patients with wet AMD post~          therapy.~        4. To determine the compliance rate for monitoring wet AMD during follow-up utilizing~          teleophthalmology.~        5. To evaluate the cost effectiveness of teleophthalmology in screening/monitoring wet AMD~          patients including direct costs to the OHIP system and indirect costs to the~          patient/caregiver.~        6. To assess patient satisfaction with teleophthalmology versus standard clinical care in~          the monitoring of post-treatment wet AMD.~        7. To evaluate teleophthalmology as a tool for communication between community based~          Optometrists /Ophthalmologists and Retina Specialists.~   "
151635|NCT01581593|"~     The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin~     solution) is effective in treating Primary Immunodeficiency (PID).~   "
151644|NCT01581476|"~     The purpose of this study is to determine whether use of blood pressure lowering drugs,~     Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs~     (statins) may have a place in the treatment of adolescents with diabetes and can help reduce~     serious long-term health problems in this population.~   "
151693|NCT01580826|"~     We hypothesize that short term infection-related benefits of human milk feeding are decreased~     by the process of pasteurization. Primary objective of the study is to compare the incidence~     of late-onset sepsis in very low birth weight infants assigned randomly to receive either~     pasteurized or raw expressed mothers'own milk.~   "
152102|NCT01575470|"~     The purpose of this study is to determine if bone marrow harvest, BMMNC separation, and~     re-infusion in adults with acute severe TBI is safe and will improve functional outcome.~      12/09/2015 Update: The study is closed to new enrollment and all follow-up visits have been~     completed. Data analysis is underway.~   "
151636|NCT01581580|"~     Background:~      - Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like~     Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered~     device called a neurostimulator (like a pacemaker) that is placed under the skin in the~     chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these~     areas helps to block the nerve signals that cause abnormal movements. Researchers also want~     to record the brain function of people with movement disorders during the surgery.~      Objectives:~        -  To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.~        -  To obtain information on brain and nerve cell function during DBS surgery.~      Eligibility:~      - People at least 18 years of age who have movement disorders, like Parkinson's disease,~     essential tremor, and dystonia.~      Design:~        -  Researchers will screen patients with physical and neurological exams to decide whether~          they can have the surgery. Patients will also have a medical history, blood tests,~          imaging studies, and other tests. Before the surgery, participants will practice~          movement and memory tests.~        -  During surgery, the stimulator will be placed to provide the right amount of stimulation~          for the brain. Patients will perform the movement and memory tests that they practiced~          earlier.~        -  After surgery, participants will recover in the hospital. They will have a followup~          visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be~          programmed and adjusted over weeks to months to find the best settings.~        -  Participants will return for followup visits at 1, 2, and 3 months after surgery.~          Researchers will test their movement, memory, and general quality of life. Each visit~          will last about 2 hours.~   "
151637|NCT01581567|"~     Background:~      - Information and samples collected from participants in medical research studies can be~     useful even after the original study is complete. Researchers can use the information and~     samples to learn more about multiple sclerosis or other immune system disorders. They can~     also be used for research into other disorders. Researchers would like to get permission to~     use samples collected from older studies to launch new lines of research.~      Objectives:~      - To look at information and samples from earlier National Institutes of Health~     Neuroimmunology Branch studies.~      Eligibility:~      - People who provided samples and medical information for earlier studies.~      Design:~        -  Researchers will contact people who took part in earlier studies. Researchers will ask~          if they can study previously collected data and samples.~        -  Data and samples may include physical exam data and psychological test results. Imaging~          study results are included. Preserved samples of body fluids and tissues may be studied.~          These include blood and urine samples.~        -  No new treatment will be provided as part of this research study.~   "
151638|NCT01581554|"~     Background:~      - Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and~     cancer of the liver. There is no cure for the infection, but several drugs have been approved~     to treat it. These drugs can keep the virus levels low. They seem to be safe for short-term~     use. But the drugs have not yet been approved for long-term use because some of them can have~     serious side effects. However, stopping treatment too soon can make the infection worse and~     may lead to more serious forms of liver disease. Researchers have not been able to determine~     a when to stop treatment. They want to study people with chronic hepatitis B infection to~     find out the best time to stop treatment and prevent the disease from causing further liver~     damage.~      Objectives:~        -  To study the safety and effectiveness of withdrawing antiviral treatment for chronic~          hepatitis B after at least 4 years of treatment.~        -  To determine whether stopping long-term antiviral treatment for chronic hepatitis B~          makes the infection worse.~      Eligibility:~      - People who are at least 18 years of age; have been taking antiviral drugs to treat chronic~     hepatitis B for at least 4 years; and are being evaluated to stop treatment.~      Design:~        -  Those in the study will be screened with a physical exam, medical history,~          questionnaire, and blood tests. They will remain under the care of their regular doctor~          during the study.~        -  They will have an abdominal ultrasound to study scarring in the liver, if they have not~          had one in the past year.~        -  Those without detectable levels of the hepatitis B virus in their blood will stop~          antiviral treatment. They will have monthly blood tests for the first 6 months to check~          virus levels, and then every 3 months afterward.~        -  Those whose blood tests show an increase in virus levels will restart antiviral~          treatment as directed by the study doctors and their personal doctor.~        -  All those in the study will be monitored until the end of the study.~   "
151639|NCT01581541|"~     Background:~      - PU-H71 is an experimental drug used to treat cancer. It works by blocking a protein in~     tumors. When this protein is blocked, it affects other proteins inside the cell that cancers~     need to grow. Researchers want to study whether PU-H71 is a safe and effective way to treat~     solid tumors and non-Hodgkin's lymphoma.~      Objectives:~      - To evaluate the safety and effectiveness of PU-H71 in solid tumors and non-Hodgkin's~     lymphoma that have not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors or non-Hodgkin's lymphoma that~     have not responded to standard treatments.~      Design:~        -  Patients will be screened with a physical exam, medical history, blood tests, and~          imaging studies.~        -  Patients will receive PU-H71 as a 1-hour dose on days 1 and 8 of a 21-day cycle of~          treatment. The first treatment cycle will be done in the hospital so that patients can~          be monitored. The next treatment cycles will be done on an outpatient basis.~        -  Patients will have blood and urine tests and eye exams.~        -  Patients will provide tumor samples for study.~        -  Patients will have imaging studies to monitor tumor response to treatment.~        -  Patients will continue to take PU-H71 for as long as side effects remain tolerable and~          their tumor or lymphoma does not worsen. Study researchers may adjust the dose if~          needed.~   "
151640|NCT01581528|"~     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in~     the laboratory may help doctors identify learn more about biomarkers related to cancer. It~     may also help doctors to find better ways to treat cancer.~      PURPOSE: This research studies samples from patients with T-cell acute lymphoblastic leukemia~     (T-ALL).~   "
151641|NCT01581515|"~     The purpose of this study is to compare the degree of stent malapposition on an immediate~     optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure~     OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with~     the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience~     PRIME® stents.~   "
151642|NCT01581502|"~     The purpose of this study is to determine choice of anticoagulant therapy during acute and~     chronic stages of ischemic stroke/TIA and short- and long-term outcomes, including stroke~     recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.~   "
151643|NCT01581489|"~     Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by~     increasing the infant's iron endowment at birth. Compared to early clamping, a delay in~     clamping in clamping of around 2-3 min provides an additional 25-40 mL of blood per kg of~     bodyweight to the newborn infant.~      The results of previous intervention studies on delayed clamping are mixed, and few have~     followed the infants beyond the perinatal period. All longer follow up studies have been~     performed in low income countries except for the investigators earlier study, showing less~     iron deficiency and improved iron stores after delayed cord clamping at 4 months of age.~      The main objective of the current study is to assess whether the time of cord clamping~     affects neurodevelopment at 4 years of age in a large sample of full-term, Swedish infants.~     The investigators hypothesis is that as delayed cord clamping improves iron stores at 4~     months, this could affect the child's development positively.~   "
152442|NCT01570985|"~     This is a study on the treatment of frozen shoulder with injection of cortisone into the~     shoulder joint. The purpose of the study is to evaluate whether injection with stretching of~     the shoulder capsule or plain injection is more effective than no specific treatment.~   "
151645|NCT01581463|"~     Liothyronine is indicated for the treatment of primary hypothyroidism. Between 6 and 10~     Million in the United States and 80 Million patients world-wide are hypothyroid, usually the~     result of autoimmune thyroiditis called Hashimoto's Disease. Hypothyroid symptoms result from~     low levels of thyroid hormones (T4 and T3) in the blood due to inadequate thyroid hormone~     production by the thyroid gland. Every tissue in the body is a thyroid hormone target and~     hypothyroid symptoms can be debilitating.~      BCT303 utilizes Liothyronine, Sodium as the active ingredient, the same Liothyronine salt~     utilized as the active ingredient in currently marketed products.~      The current gold standard for treatment of hypothyroidism are products containing~     Levothyroxine (T4). T4 is known to be a pro-hormone, converted to the more active hormone T3~     by deiodinases in various tissues. Patients on Levothyroxine therapy alone are occasionally~     not euthyroid as measured by clinical presentation, a condition hypothesized to result from~     low levels of T3 from inadequate T4 to T3 conversion. In addition, the efficiency of~     conversion of T4 to T3 is variable and dependent on the patho-physiologic state of the~     patient.~      BCT303 contains Liothyronine, Sodium as the active ingredient. This product has a patented~     formulation and granulation procedure that solves multiple clinical and stability problems~     associated with T3-based products. Thus, BCT303 is designed to have:~        1. Increased shelf stability to ensure the maintenance of claimed dosage.~        2. A sustained-release profile to minimize side effects associated with spikes in serum T3~          levels.~        3. Uniformity of dose between production batches and between tablets.~   "
151646|NCT01581450|"~     Evaluation of the effects of 35%/15%/50% N2O/N2/O2 mixtures on the area of hyperalgesia~     induced by remifentanil in the CCES (Continuous Cutaneous Electrical Stimulation) model in 20~     healthy volunteers.~      The duration of participation for each volunteer is expected to be around 9 weeks with the~     performance of 4 experimental session 2 weeks apart.~      The selection visit will last half a day; each experimental session will last half a day; the~     study end will last 2 hours maximum.~   "
151647|NCT01581437|"~     The 64 pole basket catheter used for the mapping procedure will be defined atypical sites~     which sustain atrial fibrillation. The ablation through the driver will lead to more rapid~     ablation of the atrial fibrillation.~   "
151648|NCT01581424|"~     The investigators will perform a study with two major components. The first is a natural~     history study of untreated Fabry patients. This study component will detail kidney~     microscopic structural changes in Fabry patients before starting enzyme replacement therapy~     and will correlate these changes with kidney function, including glomerular filtration rate~     and urinary albumin excretion rate. The investigators will perform studies on samples~     obtained at baseline, or before enzyme replacement therapy is initiated. The goal of our~     study is to find kidney microscopic changes in the biopsies that are associated with kidney~     disfunction. Our hypotheses for this study are:~        1. Much of the natural history of Fabry renal structural changes will occur without~          detectable renal functional alterations.~        2. Structural changes associated with the initial onset of proteinuria and those associated~          with the subsequent progressive loss of filtration function will differ and will be best~          described by non-linear models.~        3. There will be sufficient precision of Fabry renal structural-functional relationships to~          support renal structure as an acceptable clinical trial surrogate endpoint for later~          renal functional deterioration.~      The second component examines the effects of age and gender at start of enzyme replacement~     therapy (ERT), as well as dosage levels of ERT on the renal cellular clearance of GL3 from~     Fabry patients by comparing baseline to follow-up kidney biopsies performed 5, 11, and 60~     months later, with all comparisons matched for ERT treatment duration. Our hypotheses for~     this component of the study are as follows:~        1. Enzyme Replacement Therapy(ERT) instituted at younger ages is more effective in reducing~          podocytes(PC),distal tubular cells(DTC),and arterial smooth muscle cells (ASMC)GL-3 than~          in older Fabry patients.~        2. Earlier institution of ERT will stabilize PC numbers while later ERT institution,~          especially in proteinuric adults, may not prevent progressive decline in PC numbers and~          associated glomerular sclerosis, tubulointerstitial injury, and GFR loss.~        3. Whereas lower ERT dose may effectively clear GL-3 from endothelial and mesangial cells,~          it will be less effective in clearing GL-3 from PC and also from DTC and ASMC.~        4. Affected cells will be cleared of GL-3 equivalently in females and males.~   "
151649|NCT01581411|"~     1. Study hypothesis: Injection of t-PA, a thrombolytic drug (clot busting medicine)into the~          ophthalmic artery (the blood vessel feeding the eye), in patients with recent severe~          central retinal vein occlusion, may reopen the central retinal vein and improve retinal~          blood flow, which may in turn improve visual acuity and prevent the long-term~          complications of the disease.~        2. Experimental intervention: An outpatient procedure during which the ophthalmic artery is~          selective catheterized (with a small plastic tube called a microcatheter introduced from~          the artery of the leg) and infused with t-PA during two hours.~   "
151650|NCT01581398|"~     The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b~     (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of~     180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study~     will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on~     the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be~     enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group~     or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily~     Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be~     enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group~     or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily~     Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks~     after the end of therapy.~   "
151651|NCT01581385|"~     This is a pilot clinical trial to assess the ability of a new ultrasound-based imaging~     method, Acoustic Radiation Force Impulse (ARFI) ultrasound, to describe the composition and~     structure of atherosclerotic plaques. The hypothesis being tested is that in vivo,~     transcutaneous ARFI ultrasound delineates plaque composition and structure in human carotid~     arteries.~   "
151666|NCT01581177|"~     The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety~     profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg~     per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI)~     Active Control.~      This study will be conducted in male and female adult patients who have mild-to-moderate~     persistent asthma for at least 6 months, but are otherwise generally healthy.~   "
151667|NCT01581164|"~     The purpose of this research study is to perform a serial analysis of immune function using~     blood cells and sera obtained from patients after vaccination following hematopoietic stem~     cell transplantation (HSCT). The focus of this study will be to characterize several immune~     parameters during the clinical course of HSCT and correlate these findings with the effect of~     vaccination.~   "
151954|NCT01577394|"~     The aim of this study is to determine whether saccadic eye movement recording may help in the~     discrimination between Lewy body dementia and Alzheimer disease, in the early stages of the~     disease.~      Study type: Interventional Study design: Intervention Model: Single group assignment Primary~     purpose: Diagnostic~   "
151652|NCT01581372|"~     Background:~      Cardiovascular disease (CVD) is the cause of one-third of all deaths in Canada. One important~     risk factor for CVD is dyslipidemia. The Canadian Health Measures survey, which was conducted~     from 2007-2009, found that roughly 36% of Canadians had unhealthy levels of LDL. Despite~     strong evidence and clear practice guidelines for the management of this risk factor, it~     remains poorly treated.~      Pharmacists are front-line primary care professionals who see patients at risk for~     cardiovascular disease more frequently than other healthcare professionals. As such,~     pharmacists have the opportunity to systematically and proactively identify patients with~     undertreated dyslipidemia, as one public health approach to chronic disease management.~      The objective of this study is to evaluate the effect of enhanced pharmacist care (i.e.,~     participant identification, assessment, care plan development, education/counseling,~     prescribing/titration of lipid-lowering medications and close follow-up) on the proportion of~     participants achieving target LDL-cholesterol levels.~      Hypothesis: Enhanced pharmacist care will result in a more significant decrease in LDL-c~     levels, than that observed in the usual care patients.~      Design:~      This is a randomized controlled trial of enhanced pharmacist care. The study will be~     conducted in twelve community pharmacies in Alberta, including several Safeway Pharmacies.~     The participant population will be composed of adults with uncontrolled dyslipidemia as~     defined by the 2009 Canadian Dyslipidemia Guidelines. The primary intervention will be~     pharmacist directed dyslipidemia care. Participants randomized to usual care will receive~     usual care from their pharmacist and physician.~      Study Implications:~      To the investigators knowledge, this study is the first randomized trial of pharmacist~     prescribing in dyslipidemia. This study will have important implications for improving~     patients' access to care, especially as most provinces are proceeding with granting~     additional prescribing authority to pharmacists. The ability to conduct this study in a~     province where pharmacists already have the ability to prescribe is unique. The results will~     also encourage more pharmacists to get involved in cardiovascular prevention and will~     increase the number of prescribers in the area of dyslipidemia.~   "
151653|NCT01581359|"~     The purpose of this study is to determine whether the administration of an analogue of~     gonadotropin-releasing hormone (GnRH) during the three months prior to the performing of an~     IVF may improve the response to ovarian stimulation, implantation rate and clinical pregnancy~     rate in patients with endometriosis/ endometriomas.~   "
151654|NCT01581346|"~     In the course of their disease patients with Non small cell lung cancer (NSCLC) often~     experience impaired psychological and physical functioning resulting in a reduced quality of~     life (QoL). The aim of the study is to explore the feasibility and the effects of an eight~     weeks combined muscle strength and endurance training on physical capacity and QoL.~   "
151655|NCT01581333|"~     Clinical trial intended to reduce the antibiotic therapy duration in in-hospital patients~     with haematological diseases who develop fever and low white blood cell count (neutropenia).~   "
151656|NCT01581320|"~     A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to~     evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the~     improvement of vitamin D in postmenopausal women with osteoporosis.~   "
151657|NCT01581307|"~     The purpose of this study is to evaluate the safety and impact on survival with treatment~     with 90-Y glass microspheres in conjunction with leucovorin, 5-fluorouracil (5-FU) and~     oxaliplatin (FOLFOX) as second-line treatment with in patients gemcitabine-refractory~     metastatic pancreatic cancer with predominantly liver metastases.~   "
151658|NCT01581294|"~     NOR-DMARD is a register-based longitudinal observational study of which the main objectives~     are to study the effectiveness of treatment of inflammatory joint diseases with biological~     disease modifying anti-rheumatic drugs (DMARDs) in clinical practice, by measuring disease~     activity, health related quality of life, function and joint damage, and to study the~     long-term safety of such treatment. Other objectives include the assessment of~     cost-effectiveness of treatment, to identify and and validate clinical, genetic and~     immunological predictors of efficacy and adverse events, to assess the impact of treatment~     with biological DMARDs on work participation and work productivity, to investigate different~     strategies for use of biological DMARDs, to assess the performance of different outcome~     measures, and to ensure a systematic and timely follow-up of patients treated with biological~     DMARDs.~   "
151659|NCT01581281|"~     The purpose of this research study is to test two medicines for migraine prevention in~     children and adolescents.~   "
151660|NCT01581255|"~     Mechanical ventilation, although life-saving, damages the lungs through what is known as~     ventilator-induced lung injury. High frequency oscillation ventilation has been proposed as a~     ventilation method that may be less injurious to the lungs than conventional mechanical~     ventilation and may lead to better patient outcomes. To evaluate this hypothesis, the~     OSCILLATE trial is comparing outcomes in patients with the acute respiratory distress~     syndrome randomized to high frequency oscillation ventilation vs conventional lung protective~     ventilation. The present study is a substudy of the OSCILLATE trial looking at biomarkers of~     ventilator-induced lung injury in blood samples drawn from patients enrolled in OSCILLATE.~     The objective is to look for biochemical evidence of decreased ventilator-induced lung injury~     in patients treated with high frequency oscillation ventilation relative to conventional~     ventilation.~   "
151661|NCT01581242|"~     This is a randomized, open-label, three-sequence, three-period, three-treatment clinical~     trial to investigate the pharmacokinetic drug-drug interaction of Clevudin and Adefovir~     dipivoxil after oral administration in healthy male subjects.~   "
151662|NCT01581229|"~     To assess the safety and efficacy of noninvasive positive pressure ventilation for patients~     with intro-pulmonary pulmonary acute lung injury and compare this with high-concentration~     oxygen therapy.~   "
151663|NCT01581216|"~     Fatigue related to cancer is the most common reported symptom and it prevents 91% of patients~     of having an active life, and in several cases, the fatigue persists for several months or~     even years after treatment. Fatigue does cause an impact in all dimensions of patients'~     quality of life and it is the main cause of reduction in patients' daily life activities.~      Fatigue is reported by cancer patients in all phases of the illness as one of the most~     frequent symptoms, especially in cases presenting metastases.~      In order to monitor fatigue, pharmacological and non-pharmacological techniques may be~     employed, such as physical activity. Physical exercise has shown positive results in~     mitigating fatigue improving cardiopulmonary functioning, physical capacity and patients'~     quality of life.~      This study will assess the efficiency of physical activity upon controlling the fatigue and~     quality of life in patients with advanced stage of the disease at the end of 7 days using~     FACT-F subscale.~   "
151664|NCT01581203|"~     The purpose of this study is to estimate efficacy, as determined by the proportion of~     subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as~     Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at~     post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who~     are treatment-naive.~   "
151665|NCT01581190|"~     This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate~     drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress,~     and innate immune function using traditional and metabolomics-based profiling.~   "
151672|NCT01581099|"~     Introduction- Primary prevention is the main strategy to control the global burden of~     cardiovascular disease. In clinical practice, food restriction represents a valuable~     preventive resource. However, low adhesion rates and diet abandonment are considered~     important obstacles in treatment. Considering the discovery of new markers and mechanisms~     that relate food restriction and to all other cardiovascular risk factors, it is possible and~     necessary to seek for efficient alternatives to increase adherence and effectiveness of the~     preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food~     restriction. The bariatric surgery have gained importance not only for its potential~     application in obesity treatment but also in the control of cardiovascular risk factors~     refractory to medical treatment. Among bariatric operations, there is a group called~     digestive adaptations III that has specific characteristics.This surgical intervention~     modifies intestinal tract by reducing gastric volume and performing an anastomosis between~     ileum and stomach, creating a bipartition in the gut. This structural modification promotes~     satiety and increased insulin sensitivity more intensely than other surgical strategies. The~     effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers~     related to the development of atherosclerosis are not yet established.~      Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and~     laboratory parameters and cardiovascular risk factors.~      Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal~     obesity will be included in the study. Of this group, half will be randomly selected to~     perform the Digestive Adaptations III surgery. All participants will undergo clinical and~     biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four~     months after surgery. On these occasions besides the lipid profile and glucose, we will~     determine incretin hormones, adipokines and assess the amount of epicardial fat.~   "
151673|NCT01581086|"~     This study is looking for high blood pressure in the lungs (Pulmonary artery hypertension~     PAH) in HIV and COPD patients.~   "
151674|NCT01581073|"~     The purpose of this study is to ask whether treating non-diabetic chronic kidney disease~     (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and~     13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The~     investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher~     adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to~     11g/dL.~   "
151675|NCT01581060|"~     The aim of part 1 of this study is to determine the optimal biological dose (OBD) and maximum~     tolerated dose (MTD) for WX-554 and the recommended dose/dose schedules for the chronic~     treatment in part 2. The aim of part 2 is to further determine the safety and tolerability of~     chronic treatment with WX-554.~   "
151676|NCT01581047|"~     Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and~     dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't~     be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized~     dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have~     unpredictable pharmacokinetics in patients on intensive care units. This is due to the~     pathophysiologic processes in the patients on intensive care units: increased distribution~     volume, hypoproteinemia, organ failure… The investigators guess that similar processes~     influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and~     cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in~     seriously ill patients are better known, physicians are more confident prescribing these~     drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously~     ill patients, can help to give the physician the confidence to prescribe these small-spectrum~     antibiotics.~      In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic~     acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a~     central catheter on different moments after one administration of the antibiotic in the~     steady state phase. All the patients are prescribed the antibiotics for the treatment of~     their infections: they get the antibiotic therapy anyway. By measuring the concentrations on~     different moments after one administration, the investigators can reconstruct the~     pharmacokinetic function.~   "
151677|NCT01581034|"~     This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week~     intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous systems~     in patients with coronary artery disease. The investigators hypothesize that PADMA 28 has a~     beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen~     and the blood inflammatory markers in patients with coronary artery disease compared to~     placebo treatment.~   "
151678|NCT01581021|"~     Scoliosis is a deformity in which there is an abnormal curvature of the spine. Surgery is the~     main method of correcting this deformity. Rods are attached to the spine to make it strait.~     There are two ways to fix these rods to the bone of the spine: laminar hooks or pedicle~     screws. Hooks are an older form of fixation and do not penetrate the bone, but are instead~     placed over a part of the vertebra called the lamina. Screws are newer and do penetrate the~     bone. Screws are placed into the part of the vertebra called the pedicle. Most surgeons think~     screws correct scoliosis better than hooks. The current literature agrees that screws are~     better for deformity correction in the lumbar spine and patients with severe deformity. There~     is disagreement in the literature regarding which works better in the thoracic spine in less~     severe deformity. There are no randomized, controlled trials in the literature that examine~     whether constructs that use hooks in the thoracic spine and screws in the lumbar spine~     (called hybrid constructs) work as well as all-screw constructs. This clinical study is a~     randomized controlled trial being conducted to evaluate treatment outcomes in patients with~     scoliosis undergoing surgical correction for their curves using either all-screw or hybrid~     constructs as fixation devices. The study population is limited to those with less severe~     deformity and the investigators' hypothesis is that hybrid constructs will be as acceptable~     as screws in terms of correction.~   "
151679|NCT01581008|"~     The overall goal of this study is to evaluate the pilot implementation of two palliative care~     interventions in veterans with chronic heart failure at the Denver VA Medical Center. This is~     a study of behavioral and care strategy interventions and involves no investigational drugs~     or devices.~   "
151694|NCT01580813|"~     People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of~     certain fats in their blood. The blood vessels and heart of most of these individuals do not~     work normally and people with T2DM also have an impaired ability to perform exercise. The~     purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily~     decrease the level of fat in the bloodstream of people with T2DM and observe the~     physiological changes to blood vessel function and exercise capacity and insulin sensitivity.~     This will help the investigators to understand ways of improving blood vessel function and~     the ability to exercise effectively in people who are overweight or have T2DM.~   "
151955|NCT01577381|"~     The purpose of this study is to determine the efficacy, safety and tolerability of multiple~     doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular~     Degeneration.~   "
151680|NCT01580995|"~     The purpose of this study is to examine the effects of valacyclovir in patients who have~     chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies~     to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold~     sores or fever blisters, also known as herpes labialis, but most persons do not have any~     symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug~     administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic~     hepatitis C infection.~      The study will take 16 weeks. Participants will be assigned to take either the study drug,~     valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and~     patients will not know which medication they are receiving. Study visits will occur every two~     weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V.~     Sonny Montgomery VA Medical Center in Jackson, Mississippi.~   "
151681|NCT01580982|"~     The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined~     from tumor tissue or tumor cell lines derived from available archival samples and/or from~     standard-of-care re-biopsy upon suspected tumor progression.~   "
151682|NCT01580969|"~     The primary objective of step 1 is the rate of adverse events of minocycline and bevacizumab~     during reirradiation and of step 2 is the response rate to bevacizumab, reirradiation, and~     minocycline. The secondary objectives are the response rate, PFS-3, PFS-6, and effects on~     quality of life and cognition from repeat radiation and bevacizumab.~   "
151683|NCT01580956|"~     Variable PSV is a new ventilatory mode which delivered a pressure support variable from 0~     to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior,~     sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and standard (or fixed)-PSV~     during the weaning phase of critically ill patients who required mechanical ventilation.~   "
151684|NCT01580943|"~     The purpose of this study was to compare the antiplaque efficacy of a 0,12% chlorhexidine and~     0,05% cetyl-pyridinium chloride mouth rinse (Perio-aid®) with a 0,2% chlorhexidine~     non-alcohol base mouth rinse (Corsodyl Care®).~   "
151685|NCT01580930|"~     The purpose of this study is to determine if individuals involved in exercise training change~     habitual activity and inactivity behavior outside of exercise training. Eligible participants~     were randomly assigned to one of four groups: control, exercise training, sedentary time~     reduction, or exercise training plus sedentary time reduction. It was hypothesized that~     participants in the exercise training group will compensate for exercise training by reducing~     free-living physical activity behavior and increasing sedentary time. Participant free-living~     behavior was monitored for one week at baseline, 3, 6, 9 and 12 weeks using an activPAL~     wearable monitor.~   "
151686|NCT01580917|"~     The purpose of this pilot study is to compare the dynamic response of microcirculation in the~     skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic~     subjects with a history of foot ulcer and 25 age-matched healthy controls to better~     understand the role of local hypoxia in neuropathic foot ulceration in subjects with~     diabetes.~      The investigators hypothesize that if they apply a gait simulating load to the plantar foot~     and measure microvascular function, diabetic individuals will demonstrate an increased delay~     in reestablishing microvascular flow compared to healthy individuals.~   "
151687|NCT01580904|"~     The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug~     treatment and to improve their quality of life. This study will measure the impact of~     pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single~     blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the~     intervention group will be held the pharmacotherapeutic follow using a methodology called the~     practice of pharmaceutical care, which identifies and resolves problems related to drugs. The~     primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total~     cholesterol and its fractions (for example LDL), all these measures will be made in the~     intervention group and control group. Patients will be followed for 24 weeks, and the~     outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a~     significance of p <0.05, and will use the Student t test, chi-square analysis of variance~     (ANOVA) and others if necessary. Expects good results and serve as a model for other~     researchers.~   "
151688|NCT01580891|"~     The objective of this study is to evaluate the efficacy and safety of the test formulation of~     Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed~     formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients~     with tinea pedis and to show the superiority of the active treatments over placebo when dosed~     once a day for 28 days.~   "
151689|NCT01580878|"~     The primary objective of this study is to determine the comparability of the safety and~     efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra®~     (the reference listed drug) in subjects with interdigital tinea pedis. It will also be~     determined whether the efficacy of each of the two active treatments is superior to that of~     the vehicle cream (placebo).~   "
151690|NCT01580865|"~     Prospective, multi-center, randomized, controlled, trial to compare tacrolimus with~     mycophenolate mofetil (MMF) for induces complete remission in lupus nephritis patients. The~     study duration is one year.~      Research hypothesis~        -  The proportion of patients who have achieved complete remission between regimen of~          tacrolimus plus prednisolone is greater than MMF plus prednisolone as an induction~          therapy in lupus nephritis.~   "
151691|NCT01580852|"~     BACKGROUND: Bathing in sweet or mineral water can induce significant physiological changes in~     several body systems including the endocrine system. To date, there have only been a small~     number of reports that balneology can reduce blood sugar Levels in patients with type 2~     diabetes mellitus (DM].~      OBJECTIVE: To compare the effects of a immersion in sweet or mineral water on blood glucose~     levels in patients with type 2 DM.~      METHODS: Forty patients with type 2 DM will immerse in either sweet or mineral water twice~     daily. In both cases the water will be warmed to a temperature of 35 degrees C and the bath~     continue for 20 minutes.~   "
151692|NCT01580839|"~     The primary hypothesis being tested in this trial is that ischaemic stroke patients selected~     with significant penumbral mismatch (according to imaging criteria) at 4.5 (or 3 hours~     depending on local guidelines) - 9 hours post onset of stroke or after 'wake up stroke' (WUS)~     will have improved clinical outcomes when given intravenous tissue plasminogen activator~     (tPA) compared to placebo.~   "
151696|NCT01580787|"~     The objective of this work was to compare the effects of two balance training programs, one~     Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,~     on the balance, functionality and cognition of patients with Parkinson´s disease. It was a~     prospective, single blinded, randomized clinical trial performed at Brazil Parkinson~     Association and Center of Research of the courses of Speech Therapy, Physical Therapy and~     Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages~     1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and~     experimental group, 16 each one.~      The study was finished at december 2011.~   "
151697|NCT01580774|"~     The purpose of this study is to determine whether a post-discharge telephone call to general~     medical patients discharged home will improve quality of care and adherence, and reduce~     hospital readmission.~   "
151698|NCT01580761|"~     Insufficient sleep may be one of the most common, and most preventable, obesity risk factors.~     The investigators wish to determine whether 14 nights of modest sleep restriction results in~     increased energy balance, thus potentially increasing the risk of obesity. The investigators~     hypothesize that sleep restriction will result in increased energy balance.~   "
151699|NCT01580748|"~     There is currently no effective treatment of bronchiectasis other than treating its~     complications such as infection, bleeding, etc. Roflumilast is a newly developed~     anti-inflammatory drug that has proven to be effective in stable COPD. We hypothesized that~     Roflumilast might be effective in symptomatic bronchiectasis patients~   "
151700|NCT01580735|"~     The primary objective of this study is to examine if the combination regimen of ARQ 197 with~     erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating~     mutation EGFR who progressed on EGFR-TKI monotherapy.~   "
151701|NCT01580722|"~     The purpose of this study is to determine which surgical method is better for anterior~     cruciate ligament teas in outcomes.~   "
151702|NCT01580709|"~     Differentiating malignant from benign bile duct strictures is a conundrum, since no~     diagnostic test is highly sensitive for diagnosing cancer. While ERCP is effective in~     palliating obstructive jaundice, standard diagnostic tools in ERCP have a low diagnostic~     sensitivity and confirm the stricture's etiology in <50% of cases. During the first ERCP,~     standard practice is to obtain routine cytology (RC) using a single brush sample. If this is~     not diagnostic, patients often undergo repeat ERCP, endoscopic ultrasound or other,~     increasing health care costs. The incremental yield of performing alternate ERCP-based~     diagnostic tools during the first ERCP including fluorescence in situ hybridization (FISH),~     cholangioscopy w/biopsy and multiple brushes for routine cytology is currently unknown. There~     are no studies quantifying the amount of testing utilized to firmly diagnose the etiology of~     the stricture, or the most efficient combination of diagnostic tools during the first ERCP.~     These are important knowledge deficiencies since a definitive tissue diagnosis during the~     first ERCP could reduce the need for downstream tests and expedite treatment, thereby~     improving patient-centered and economic outcomes. The added costs of using multiple tools~     during the first ERCP may be offset by these benefits.~      Among patients with indeterminate bile duct strictures, the investigators hypothesize that a~     multimodality approach will be more sensitive without a significant reduction in specificity~     compared to multiple brush samples for routine cytology. The investigators will test this~     hypothesis using an experimental trial design by randomizing patients during their first ERCP~     to multiple brushing samples for cytology vs. a single brush sample for cytology + FISH +~     cholangioscopy w/biopsy. To obtain preliminary data for a definitive multi-center trial, the~     investigators propose a pilot and feasibility study to compare the performance~     characteristics of each approach by evaluating the prospective clinical course, including~     treatment delay, quality of life, and life expectancy for each enrolled patient. If our~     hypothesis is validated in a subsequent definitive study, the standard approach to tissue~     sampling during the first ERCP may be altered.~   "
151703|NCT01580696|"~     Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial~     cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T~     lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The~     purpose of this study is to test whether a peptide-based vaccine consisting of the E39~     peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating~     factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune~     response. Furthermore, the investigators intend to determine the best dose of the vaccine to~     utilize to produce this immunity most efficiently. The investigators will determine whether~     immunity to FBP will prevent clinical recurrence. Additionally, the investigators will~     compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu~     protein) in ovarian and endometrial cancer patients in preparation for studying a combination~     vaccine.~   "
151704|NCT01580683|"~     The purpose of this study is to determine if vitamin C decreases the chance of developing~     atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery.~     This irregular heartbeat is a common occurrence following cardiac surgery, and occurs in~     about one third of patients. It poses extra risks to people who develop it. Our hypothesis is~     that Vitamin C will decrease the incidence of postoperative atrial fibrillation.~   "
151705|NCT01580670|"~     The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's~     Disease Activity Index (PCDAI) and other evaluation indicators in pediatric patients with~     moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at weeks~     0, 2, and 6, then every 8 weeks after week 14 up to week 46, and at a dose of 10 mg/kg if the~     effect is attenuated. The safety and pharmacokinetics are also evaluated.~   "
151706|NCT01580657|"~     Randomized clinical trials of HIV prevention interventions typically include extensive~     baseline assessments of the risk behaviors that interventions target. Such pretests have the~     potential to direct participants' attention to the factors that put them at risk of HIV~     infection. Evidence from intervention study control groups, the motivational enhancement and~     attitude change literature, and our preliminary studies suggest that assessments that lead~     people to think about behaviors with potentially negative outcomes lead to motivation for~     risk behavior reduction. As a consequence, HIV intervention research using baseline~     assessments may not accurately predict the impact of a given HIV prevention intervention~     outside of the research context, in particular when interventions are evaluated among~     high-risk, isolated individuals. However, the actual effects as well as public-health~     consequences and mechanisms of HIV assessment reactivity have never been systematically~     tested.~      The proposed assessment reactivity study will be conducted in South Africa, a country with~     high levels of HIV prevalence, incidence, and stigma. The Republic of South Africa's HIV/AIDS~     epidemic has emerged recently relative to other sub-Saharan countries, and yet 21.5% of South~     Africans aged 15-49 -- more than 1 in 5 people -- are infected with HIV (UNAIDS, 2004).~     Despite the common presence of HIV in South Africa, it remains largely a hidden disease and~     HIV-related stigma interferes with peoples' ability to protect themselves through open~     discussion or spontaneous reflection on personal risk. Under these conditions, it is~     reasonable to expect a sizable effect from directing people's attention to their HIV relevant~     behaviors, an effect that could be incorrectly ascribed to brief interventions used in~     low-resource settings. The conditions in South Africa, therefore, heighten the clinical and~     public health significance of the assessment reactivity issue in that (a) it is vital to~     understand how reactivity may affect the results of behavioral intervention trials, and (b)~     it may be possible to capitalize on assessment reactivity through brief, assessment-based~     interventions.~      This study will allow us to achieve our primary aim:~      1. To separate the effect of a brief HIV-risk reduction intervention from the potential~     effects of two types of baseline assessment commonly applied in HIV intervention research: a~     detailed, calendar-based assessment and a general frequency assessment. The detailed~     calendar-based assessment will potentially lead participants to observe themselves in~     specific risk-behavior situations, providing them with the opportunity to reassess the risk~     involved in those situations in light of their health goals and thus motivating them for~     behavior change. The general frequency assessment will merely prompt participants to estimate~     the overall frequency with which they engaged in several HIV-related behaviors. The effect of~     these assessments on participants' sexual behavior will be examined alone and in combination~     with the HIV-risk reduction intervention.~      In addition, this project has two important secondary aims:~        1. To generate urgently needed additional efficacy data for a promising HIV risk reduction~          intervention culturally tailored for use and found to be effective in South Africa~        2. To determine potential HIV preventive effects of different types of HIV risk behavior~          assessments on risk behavior reduction in South Africa for future intervention~          development~      To achieve the above aims, the investigators will:~        1. Recruit 1500 patients (50% women), age 18-44, from the Spencer Rd. STD Clinic, Cape~          Town, South Africa.~        2. Randomly assign participants within gender to one of 6 study arms in a modified Solomon~          Four-Group (SFG) design. The 2 (intervention: standard of care vs. an efficacious theory~          based HIV prevention intervention) x 3 (baseline face-to-face interview: none vs. basic~          single-item frequency questions vs. detailed partner-by-partner calendar-based~          interview) factorial design is depicted below:~   "
151707|NCT01580644|"~     The purpose of this study is to evaluate the amount of GLPG0187 present in the blood~     (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy~     subjects.~      Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and~     dose proportionality of the best formulation.~      Furthermore, during the course of the study, safety and tolerability will be characterized.~   "
151717|NCT01580514|"~     Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has~     significant cardiovascular protective effects in various conditions. The investigators~     examined whether conventional use of exenatide at the time of primary percutaneous coronary~     intervention would reduce the infarct size in patients with ST-segment elevation myocardial~     infarction (STEMI).~   "
151718|NCT01580501|"~     PDE5A inhibition, which boosts NO-cGMP signaling, will relieve functional muscle ischemia and~     restore normal blood flow regulation (i.e., functional sympatholysis) during exercise in boys~     with DMD. The investigators specific aim is to perform an efficient dose-titration study to~     inform the design of a randomized multicenter trial of PDE5A inhibition for clinical skeletal~     muscle and cardiac endpoints.~   "
151719|NCT01580488|"~     The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different~     formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the~     psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.~   "
151708|NCT01580631|"~     Narrow Band Imaging(NBI) improves image contrast by allowing the blue light centered at 415~     nanometers which is heavily absorbed by oxyhemoglobin to highlight the tissue's~     microvasculature and enhances detail on the surface of the mucosa revealing subtle changes.~     Barrett's esophagus(BE) has the mucosal and vessel changes during cancer transformation by~     angiogenesis. The ability of the NBI scope to visualize submucosal vessels forms the premise~     for the prediction of dysplasia in BE mucosa.~      NBI images of the BE mucosa obtained during endoscopy will be classified by academic~     endoscopists and community endoscopists initially. The endoscopists will then be asked to~     predict histopathology based on the NBI surface patterns. This clinical trial will evaluate~     the inter-observer agreement of a simple, consensus driven narrow band imaging (NBI)~     classification system of surface patterns and its ability to differentiate dysplastic versus~     non-dysplastic Barrett's esophagus(BE) in patients undergoing BE screening or surveillance in~     expert academic centers and in community GI practice as well. Their performance will be~     evaluated for accuracy, sensitivity, specificity, positive predictive value and negative~     predictive value of each pattern that is visualized on NBI.~   "
151709|NCT01580618|"~     The objective of the study is to determine the safety and efficacy of TNK infusion for the~     treatment of loculated pleural effusions in patients with known malignancy compared to normal~     saline infusion.~   "
151710|NCT01580605|"~     This study is conducted in Europe. The aim of this study is to extract data from the French~     National Registry holding information about patients having initiated growth hormone therapy~     with the objective to describe patients receiving growth hormone therapy, assess efficacy and~     safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.~   "
151711|NCT01580592|"~     Urticaria is a very frequent skin condition characterised by transient wheal and flare type~     skin reactions associated with severe pruritus. Cold contact urticaria (CCU) is a frequent~     form of physical urticaria that is characterized by the development of wheal and flare type~     skin reactions due to the release of histamine and other proinflammatory mast cell mediators~     following exposure of the skin to cold. Among all physical urticaria subtypes the frequency~     of CCU varies between 5.7% and 33.8% in different studies. Physical urticarias including CCU~     are known to severely impair the quality of life of affected patients.~      The treatment of choice in CCU, as well as in other inducible forms and spontaneous~     urticaria, are non-sedating H1 antihistamines. Recent data have shown that updosing of H1~     blockers is significantly more effective in reducing symptoms in cold urticaria than~     standard-dose treatment. Thus, patients who cannot be sufficiently controlled with~     standard-dose antihistamines should receive high-dose H1 blockers up to 4 times the standard~     dose as recommended by the new international guidelines for the management of urticaria.~      Previous phase II studies in patients with chronic spontaneous urticaria have shown favorable~     results for the treatment with omalizumab (Xolair®). Proof-of-concept data from completed~     studies suggest that omalizumab improves urticaria in patients with chronic spontaneous~     urticaria who have failed treatment with H1 antihistamines as well as those who have failed~     treatment with a combination of H1 and H2 antihistamines and a leukotriene receptor~     antagonist. In addition, two case reports of patients with severe therapy refractory CCU~     treated with omalizumab reported a complete response with no urticarial symptoms after cold~     challenge. In summary, these data suggest that omalizumab may have a beneficial effect in the~     treatment of CCU.~   "
151712|NCT01580579|"~     Lung cancer [LC] is the leading cause of cancer death worldwide. The standard treatment of~     locally advanced lung cancer unresectable or marginally resectable is combination therapy~     with radical or preoperative chemoradiation. The local control rates and survival with this~     treatment modality have increased by more than 30%. Radiotherapy [RT] with technical molded~     3D [3D-CRT, Three-Dimensional Conformal Radiation Therapy] or IMRT [intensity-modulated~     radiation therapy] has allowed that the total dose of radiation has increased which leads to~     a direct benefit on the results treatment.~      Between 17-30% of patients are susceptible to pneumonitis due to radiation [NR]. This~     complication may appear at the end of the RT or up to 6 months after the treatment. In severe~     cases, mortality can reach 50%.~      It's well known that in various diseases, functional abnormalities precede the clinical~     manifestations. The degree of pulmonary failure secondary to RT is measured following the~     standards of the Radiation Therapy Oncology Group who ranks in degrees [0 to 4].~      Not precisely known factors that influence the development of NR.~   "
151713|NCT01580566|"~     The purpose of this study is to determine if a sizable myocardial infarction (heart attack)~     results in negative changes to renal structure and function (i.e. has a negative impact on~     the kidneys).~      To determine if the renal response to a myocardial infarction is a predictor of the patients~     future health.~   "
151714|NCT01580553|"~     The purpose of this study is to evaluate the efficacy and safety of L-carnitine injection in~     treatment of Chinese patients with heart failure.~      A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical~     study was performed.~      Treatment period: 7 days, follow-up: 1 month~   "
151715|NCT01580540|"~     The study aims to show non-inferiority in the clinical performance of the investigational~     assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline~     eligible subjects.~   "
151716|NCT01580527|"~     Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality~     partially related to the altered nutritional status of the patients. The perioperative~     malnutrition is a major risk factor of postoperative complications and worsens the prognosis~     of the patients. The perioperative artificial nutrition has for objectives to correct the~     preoperative malnutrition, and to maintain the nutritional status in the post-operative~     period. The current guidelines in surgery are in favour of a realisation of a perioperative~     artificial nutrition support that privilege the enteral nutrition. However, after~     pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the~     early postoperative period, although rare studies suggest a benefit of the enteral nutrition~     in term of reduction of the post-operative complications. Indeed, no recommendation was~     formulated concerning early enteral nutrition after pancreaticoduodenectomy because few~     studies were realized on its profits.~      The data of the literature report rates of complications (essentially major) from 49 % to 59~     % after major digestive surgery (not only pancreatic) on patients having received a total~     parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early~     enteral nutrition.~      A preliminary prospective study realized in the investigators centre showed a rate of 74 %~     complication versus 44 %, respectively in the total parenteral nutrition and early enteral~     nutrition groups (50 patients in every group, with p < 0.01. All the complications were~     listed prospectively).~      Hypothesis :~      The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at~     least, 19 % complications of any stage according to the classification of Dindo-Clavien (59 %~     versus 40 %).~   "
152016|NCT01576588|"~     The study will test the efficacy rituximab in addition to glucocorticoids for the treatment~     of B-CLL in elderly or unfit patients.~   "
151720|NCT01580475|"~     -  This study examine the effects of training, detraining and retraining, using a combined~          strength and aerobic exercise program, on physiological parameters in patients with type~          2 diabetes.~        -  Thirteen women with type 2 diabetes followed a supervised aerobic and strength training~          program for 9 months, interrupted for 3 months (detraining) and resumed again for a~          period of 9 months (retraining).~        -  Training improved body mass index, fasting plasma glucose,postprandial glucose,~          glycosylated hemoglobin, peak oxygen consumption,power output and total muscle strength.~          Detraining reversed PPG, HbA1C and physical fitness parameters. Resumption of training~          however, improved further the initial training adaptations.~        -  Diabetic patients should follow a regular and uninterrupted exercise program throughout~          life in order to control glucose metabolism and improve health status.~   "
151721|NCT01580462|"~     The aim of the research is to develop a mathematical model called ADHERENCE index, and to~     evaluate its effectiveness.~   "
151722|NCT01580436|"~     De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following~     mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve~     annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when~     tricuspid annular dilatation is present even in absence of significant TR. However, whether~     such a strategy of prophylactic TVP results in improved outcomes has not been shown to date~     by a prospective randomized study. The investigators goal is therefore to initiate such a~     study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients~     scheduled for mitral valve surgery and tricuspid annular dilatation but <2+ TR.~   "
151723|NCT01580423|"~     Substance P is released from sensory nerves and transmits pain information into the central~     nervous system. As pain and dyspnea share many characteristics, including similar~     neurological pathways, it is possible that substance P may contribute to the sensation of~     dyspnea. The hypothesis of the study is that patients with chronic obstructive pulmonary~     disease (COPD) will provide lower ratings of breathlessness during resistive load breathing~     with oral aprepitant, a medication that blocks the activity of substance P, compared with~     placebo.~   "
151724|NCT01580410|"~     This randomized phase II trial is studying the side effects and how well giving oxaliplatin~     or mitomycin C directly into the abdomen after surgery works in treating patients with tumors~     of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen~     may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells~     that remain after surgery.~   "
151725|NCT01580397|"~     Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas~     (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor~     prognosis with progression-free survival of around 13 weeks and median overall survival of~     approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin~     may be preferentially concentrated in pancreatic cancers that appear to be starved for this~     protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based on~     its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin without~     increasing its toxicity, as has been demonstrated in animal studies, and induce enhanced~     anti-tumor efficacy.~   "
151726|NCT01580384|"~     This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability~     of neurocognitive tests and functioning scales for the measurement of cognitive and~     functioning changes in individuals with Down Syndrome. Tests will be administered at clinic~     visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between~     24 and 27 weeks.~   "
151727|NCT01580371|"~     This study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT),~     safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with~     Lymphoma failed to standard therapy. The usefulness of the this regimen is evaluated by~     response rate, progression free survival.~   "
151728|NCT01580358|"~     Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help~     these people improve the quality of life.~   "
151729|NCT01580345|"~     The 'DHANI randomized controlled trial seeks to examine the effects of prenatal DHA~     supplementation on newborn anthropometry where in healthy pregnant will be assigned to~     receive either 400 mg of DHA or a placebo daily from ≤20 weeks gestation through delivery.~   "
151730|NCT01580332|"~     Recent studies have shown that low-dose chest CT scans can detect lung cancers in high-risk~     populations (age >50yo, >30 pack-years of tobacco use), and can lower cancer mortality.~     Unfortunately, the vast majority of positive findings on these CT scans are benign (>95%).~     Currently, an inordinate amount of expensive follow-up testing is required for these patients~     to try to prove who among them truly has a cancer.~      Several new emerging non-invasive and potentially cheaper tests are now being investigated to~     help differentiate patients with cancers versus just benign lung nodules. These new tests~     include a new type of sputum analysis, a breath analysis, a blood test measuring certain~     tumor markers, a blood test looking for auto-antibodies, and a standard PET/CT scan. Each of~     these tests have different sensitivity and specificity rates when looking for lung cancer,~     and it is unclear which test is best.~      This study will employ a panel of all 5 of these non-invasive tests on an initial cohort of~     50 patients with recently diagnosed lung cancer to try to measure the sensitivity of the~     tests. A follow-on study will then perform the same panel of tests on 300 lung nodule~     patients to see which test, or combination of tests, gives the best overall accuracy in terms~     of predicting who really has lung cancer. It is hoped that the use of such a panel could lead~     to dramatically decreased need for expensive and morbid invasive testing for this population.~   "
151731|NCT01580319|"~     This research project is about a physical activity intervention in pediatric outpatients to~     try control and prevent heart diseases such as hypertension, obesity, high cholesterol.~   "
151732|NCT01580306|"~     The main objective of this study is to investigate the influence of mild, moderate and severe~     renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control~     group with normal renal function after single dose of BI 201335.~   "
152017|NCT01576575|"~     The purpose of this study is to determine how people absorb and break down (metabolize) and~     eliminate buprenorphine and if CYP3A is involved.~   "
151733|NCT01580293|"~     Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to~     form blood clots is missing or not present in sufficient levels. In a person with haemophilia~     A, the clotting process is slowed and the person experiences bleeds that can result in~     serious problems and potential disability.~      The current standard treatment for severe haemophilia A is regularly scheduled infusion of~     FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII,~     prophylaxis may require treatment as often as every other day.~      In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is~     evaluated in subjects with severe Hemophilia A.~      120-140 patients will receive open label treatment with long-acting rFVIII either on-demand~     to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension~     to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic~     treatment will receive study drug at dosing intervals between once and twice a week depending~     on their observed bleeding. Patients will attend the treatment centre for routine blood~     samples and be required to keep an electronic diary.~      Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at~     least 50 exposure days may be eligible for this study.~   "
151734|NCT01580280|"~     Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper~     thoracic thrust manipulation will demonstrate significant and clinically important changes in~     outcomes when compared to the mobilization and exercise group.~   "
151735|NCT01580267|"~     Anemia (decreased number of red blood cells) is common in critically ill trauma patients~     admitted to an Intensive Care Unit and is associated with a high rate of blood transfusions.~     This anemia of inflammation is a result of three mechanisms: impaired iron regulation,~     shortened red blood cell life span, and reduced rate of erythropoiesis (a protein that helps~     make new red blood cells).~      Hepcidin, a protein made in the liver, regulates iron and is decreased when iron in the blood~     is low. This can lead to anemia.~      This research study is being conducted to learn how inflammation, hepcidin, and~     erythropoietin interact in critically ill patients. The findings will help in determining~     effective treatment for patients with anemia of inflammation.~   "
151736|NCT01580254|"~     This study examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops~     preparations, commercially available in Italy, in subjects affected by primary open angle~     glaucoma.~   "
151737|NCT01580241|"~     The investigators believe DCAMKL-1 is a stem cell tumor marker and is elevated in patients~     with pancreatic cancer. The investigators would like to analyze its expression pre and post~     treatment, to gauge the correlation between current pancreatic cancer therapies and the~     expression of DCAMKL-1~   "
151738|NCT01580228|"~     This study is being conducted to demonstrate the superiority in progression-free survival~     (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants~     with del 17p or in the overall population who are refractory to either fludarabine treatment~     or chemoimmunotherapy.~   "
151739|NCT01580215|"~     This is an observational prospective single arm multicentre study to observe the effect over~     5 years of Zephyr endobronchial valve therapy for emphysema.~   "
151740|NCT01580202|"~     Patients with chronic hepatitis B who are undergoing anticancer chemotherapy are at risk of~     HBV reactivation and hepatitis flare. Lamivudine (LAM) prophylaxis has been recommended in~     such circumstance according to the practice guidelines despite of limited evidence. However,~     failure of LAM prophylaxis including virologic breakthrough and withdrawal hepatitis occurs~     occasionally, which may lead to liver-related morbidity and mortality as well as premature~     interruption or a delay of chemotherapy. Given relatively frequent drug resistance of LAM,~     studies on the proper prophylactic antiviral regimen is warranted. The present multicenter,~     prospective, randomized study aims to compare the effect of entecavir (ETV) versus LAM for~     the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic~     malignancy undergoing cytotoxic chemotherapy.~   "
151741|NCT01580189|"~     The purpose of the study is to examine the effects of consuming protein supplement (whey)~     compared to whole milk immediately after bouts of resistance training on muscular strength~     and body composition.~   "
151742|NCT01580176|"~     This study will be the first study in which the new central venous microdialysis-based~     continuous glucose monitoring system (Continuous GlucoseMonitor) is used to investigate the~     performance of this Continuous GlucoseMonitor, as the measurements will be compared with a~     point of care reference (RAPIDLab® 1265 blood gas analyser). Further important points are~     also much less blood samplings / blood loss for the patient and personnel costs.~   "
151743|NCT01580163|"~     The purpose of this research is to observe the efficacy of comprehensive treatment model to~     improve treatment compliance and relapse prevention.~   "
151744|NCT01580150|"~     The purpose of this study is to investigate whether berries are effective in lowering blood~     glucose and insulin responses to meals containing starch or sucrose.~   "
151745|NCT01580137|"~     The purpose of this study is to find out if we can predict the progress of acute upper~     respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by~     symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric~     oxide measurement.~   "
151746|NCT01580124|"~     Study design:~      Randomized prospective comparison of pulmonary vein isolation alone versus a strategy aiming~     for atrial fibrillation termination by using a stepwise approach consisting of pulmonary vein~     isolation, biatrial defragmentation aiming for fractionated electrograms and linear ablation~     if required.~   "
151747|NCT01580111|"~     In resolving lactic acidosis among children with severe malarial anemia, there is no~     difference between those transfused with blood of longer storage compared to shorter storage~     age~   "
151748|NCT01580098|"~     Evaluation whether the introduction of large-scale personalized and technology supported~     telemonitoring and health coaching interventions produces benefits in terms of health related~     quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In~     addition, the trials evaluate the economical and organizational impact of the new services~     and examine their acceptability by patients and health professionals.~   "
152057|NCT01576055|"~     The primary objective of the randomized study is to evaluate the safety and effectiveness of~     the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions,~     ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of~     patients with symptomatic peripheral arterial disease (PAD).~   "
151749|NCT01580085|"~     Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of~     the airway and frequent awakenings during sleep. Repeated episodes of hypoxia, decrease in~     intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall~     may ensue. An increased tendency for coagulation has also been reported in OSA. Venous~     stasis, vascular endothelial activation and hypercoagulability are also known risk factors~     for thromboembolism. All of these pathophysiologic changes in OSA may predispose patients for~     the development of pulmonary embolism (PE) however there is limited data about role of~     thromboembolic events in OSA.~   "
151750|NCT01580072|"~     Evaluation whether the introduction of large-scale telemonitoring of patients with COPD~     produces benefits in terms of reduced hospital readmissions, improved health related quality~     of life and health status. In addition, the trials evaluate the economical and organizational~     impact of the new services and examine their acceptability by patients and health~     professionals.~   "
151751|NCT01580046|"~     The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients~     with renal dysfunction.~   "
151752|NCT01580033|"~     Haemophilus influenzae is an important pathogen which can cause primary infection and~     respiratory viral infection in infants and leaded to secondary infections. The infection of~     haemophilus is a major cause of morbidity and mortality in infants and children. At present,~     the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine~     can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused~     by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal~     immune programming.~      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent~     years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus~     polysaccharide vaccine with a relatively poor immune response in the infants under the age of~     two, and the remaining 60% with a low antibody level and a short duration.~      The immunogenicity and safety of this vaccine has been proved in older children aged 6-23~     months and 2-5 years. And in the phase I study which was conducted in February, 2012, the~     safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. The~     phase III study is aimed to further evaluate the safety and the immunization of the vaccine.~     The objective of this study is to evaluate the safety of the group A, C polysaccharide~     meningococcal and type b haemophilus influenzal conjugate vaccine.~   "
151753|NCT01580020|"~     The study is intended to characterize the clinical benefit regarding safety and efficacy of a~     long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and~     a 3-month follow-up period, following the initial 6-month treatment in the respective core~     studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).~   "
151754|NCT01580007|"~     Vitamin D exerts its effects via the Vitamin D Receptor (VDR) present in activated~     macrophages and induces expression and release of the cathelicidin, LL-37, a human~     antimicrobial peptide involved in killing of MTB. We aimed to investigate whether treatment~     of newly diagnosed pulmonary TB patients for 2 months with adjunctive PBA and vitamin D~     (Cholecalciferol) in combination with standard DOTS therapy (i) can improve response to~     standard short course TB therapy towards a rapid recovery; (ii) can induce expression of~     LL-37 in macrophages; (iii) can enhance killing capacity of macrophages isolated from TB~     patients infected in vitro with MTB; and (iv) does not evoke any adverse effects.~   "
151755|NCT01579994|"~     About 18 patients will take part in the phase 1 portion of the trial. In the beginning of the~     study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard~     dose of crizotinib. If this dose does not cause significant side effects, it will be~     increased as new patients take part in the study. The study will only be open at Memorial~     Sloan Kettering Cancer Center.~   "
151756|NCT01579981|"~     After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased,~     while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this~     study is to establish causality between the two observations. By meal testing 10 T2D subjects~     with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3~     months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function~     and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec~     blockade before and after RYGB on ad libitum energy intake is examined~   "
151757|NCT01579968|"~     This study is conducted in Japan. The aim of this non-interventional study is to investigate~     the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing~     surgery under normal clinical practice conditions.~   "
151758|NCT01579955|"~     This study is conducted in Japan. The aim of this non-interventional study is to investigate~     the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal~     clinical practice conditions.~   "
151759|NCT01579942|"~     The investigators are doing this study to find out if they can use electroencephalographic~     (EEG) recordings, which measure brain waves, to predict response to antidepressant~     treatments, as well as to distinguish patients who have depression from those who do not. In~     particular the investigators want to test the usefulness of a new type of analysis of EEG~     recordings called brain network activation or BNA. BNA allows to identify patterns of~     activation in brain networks and to track their changes over time.~   "
151774|NCT01579747|"~     Ultrasound have been shown to improve the time needed to locate and block nerves in the non~     obese population. However, its utility is still unknown in the obese population. Ultrasound~     is known to produce poorer quality images in the obese population. This study aims to find~     out if it is a better tool for nerve localization compared to the traditional nerve~     stimulation technique.~   "
151775|NCT01579734|"~     The propose of this trial is to assess the effect of low dose tamoxifen for breast cancer~     prevention in HRT (Hormone Replacement Therapy)users.~   "
151776|NCT01579721|"~     Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and~     cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma.~     However, the feasibility of this procedure in rectal surgery has not been determined yet. The~     aim of this study is to evaluate our initial experience using single port access in~     laparoscopic rectal surgery.~      Design: randomized, prospective clinical study Patients: 40 patients~   "
155926|NCT01525212|"~     The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid~     (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype~     1a and 1b HCV infected subjects~   "
151760|NCT01579929|"~     The purpose of this study is to test the safety of study drug LDE225 at different dose~     levels. The investigators will be testing three different dose levels and the dose will~     depend on when the patients enters the study and which dose is being tested at that time. At~     the same time, the investigators will also be testing the safety of LDE225 in combination~     with etoposide and cisplatin.~      The investigators also want to learn more about how to manage side effects the patient may~     develop during chemotherapy. Cancer patients may develop side effects during treatment, such~     as nausea, pain, fatigue, diarrhea, constipation, or shortness of breath. These symptoms may~     be due to the cancer itself, or due to treatments. Doctors and nurses often ask patients~     about their symptoms, because an important part of cancer treatment is to make patients feel~     as well as possible. If patients do not feel well, the investigators may need to change the~     way they are treating the patients or prescribe therapies that will decrease their symptoms.~      The best way to find out how the patient is feeling is to ask them directly. The~     investigators are interested in developing new ways to ask patients about how they are~     feeling, using the Internet. A special new website called STAR (Symptom Tracking and~     Reporting for Patients) has been developed to help patients record this information, so that~     their doctors and nurses can review it during clinic appointments. This study is designed to~     help us see if STAR is a helpful way for us to keep track of information about patients'~     symptoms and quality of life. The information from STAR is going to be placed on a very~     secure Internet site. This will provide your doctor with all of the information needed to~     determine if this drug combination is safe enough for you and whether to continue it.~   "
151761|NCT01579916|"~     This prospective annual release study was designed to assess the safety of a trivalent~     influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season~     not previously contained in the trivalent intranasal FluMist vaccine.~      Three hundred healthy adults will receive a single dose of vaccine or placebo and will be~     followed for 180 days after study vaccination.~   "
151762|NCT01579903|"~     This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when~     administered as 2 different dose presentations. The first is the current product vials with~     prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.~   "
151763|NCT01579890|"~     This was a compassionate use, open treatment safety study of Pennsaid topical lotion~     (diclofenac) for osteo or rheumatoid arthritis.~   "
151764|NCT01579877|"~     The aims of this study are to investigate the effect of famous herbal formula extract on~     xerostomia, and to determine whether this formula affect various xerostomia-related~     questionnaires, salivary flow rate, residual saliva and salivary tests.~   "
151765|NCT01579864|"~     Myorelaxation is generally used as a part of general anesthesia for interventional rigid~     bronchoscopy. Succinylcholine is most often used because its short duration of action but~     rocuronium can be used since sugammadex permits a rapid and complete reversal of the~     neuromuscular block. The aim of ths study is to compare both agents.~   "
151766|NCT01579851|"~     Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its~     administration could induce signs of recovery despite continuation of anesthetic drugs. The~     goal of the present study is to look is the arte of this event is different according to the~     primary anesthetic agent used.~   "
151767|NCT01579838|"~     The investigators have identified patients with CD59 deficiency that suffers from chronic~     hemolysis and peripheral demyelinating disease. It was shown that complement terminal pathway~     can cause inflammation in the peripheral nervous system. Complement can greatly increase the~     immune attack in the nerves. Eculizumab has already been shown to be effective in a rare~     blood disorder known as paroxysmal nocturnal hemoglobinuria (PNH). Attacks of PNH are also~     mediated through complement. Therefore, the investigators of this study are investigating~     whether by 'turning off' complement in CD59 deficiency, further attacks of hemolysis and~     nerve injury can be avoided and whether the neurological status will ameliorate.~   "
151768|NCT01579825|"~     Hypothesis:~      The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who~     receive bicarbonate buffer at the time of polio immunization.~   "
151769|NCT01579812|"~     The primary objective of this study is to determine if metformin administered in combination~     with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube cancer~     will improve recurrence-free survival at 18 months compared to controls.~   "
151770|NCT01579799|"~     This is a pilot dose-finding study, which is performed with a randomized, double-blind,~     3-armed, unbalanced, cross-over study design. Three of four different doses of L-lysine~     Monohydrate (A = 0.5 g, B = 1.2 g, C = 3.0 g and D = 7.5 g) will be applied in a randomized~     sequence on three different study days in six healthy volunteers. Each study day involves the~     repeated measurement of gastric content volume, gastric secretion volume and intestinal fluid~     volume using MRI before and after intragastric infusion of L-lysine Monohydrate test meals.~     Additionally, symptoms for hunger, fullness, nausea, bloating, abdominal cramps and urge to~     defecate will be recorded using a scale from 0-10. In parallel, samples of gastric juice to~     measure intragastric pH and pepsin concentration, samples of venous blood to assess blood pH~     and haematocrit as well as L-lysine, Serotonin, chloride bicarbonate and albumin plasma~     concentration and samples of arterialized blood from ear lobe to measure glucose blood~     concentration will be collected~   "
151771|NCT01579786|"~     The aim of the study was to evaluate if acupuncture may reduce intraoperative ULTIVA~     (remifentanil) consumption and post operative pain measured with VAS, italian version Mc Gill~     Questionnaire Pain and drug consumption (acetaminophen daily consumption).~   "
151772|NCT01579773|"~     The purpose of this study is to learn if women gain weight using progestin-only methods of~     contraception and if so, how much. The investigators will look at users of two progestin-only~     methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC) and the~     etonorgestrel (ENG) subdermal implant, and compare these users' weight change to that of~     users of a non-hormonal method, the copper intrauterine device.~      The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition~     will increase more than the copper-IUD users. The investigators will collect body composition~     data using dual-energy x-ray absorptiometry (DEXA), and collect information about diet and~     activity using validated questionnaires.~   "
151773|NCT01579760|"~     The purpose of this study is to assess the safety of intravitreal aflibercept injection - in~     the treatment of macular edema associated with retinopathy secondary to previous radiation~     therapy.~   "
151777|NCT01579708|"~     Cardiovascular disease continues to be the principal cause of death in the world. At present,~     the risk factors for cardiovascular disease continue to appear at an earlier age permitting~     prevention activities and the promotion of healthy habits to focus on children. Numerous~     studies have shown that these factors can be controlled in children through school-based~     interventions. At the same time, data shows that there is a persistence of unhealthy~     lifestyles (ie sedentary lifestyles, the use of tobacco, etc…) that begin in childhood and~     are perpetuated until adulthood. Therefore, the acquisition of healthy lifestyles should~     begin as early as possible. The SI Program for Preschool Education is an intervention that is~     both school and home based designed to improve the habits, knowledge and attitudes in four~     key areas: Food (diet), Physical Activity, Knowledge of the Body and Managing Emotions. This~     intervention will be implemented in children from three to five years of age, in their~     parents and in their teachers. To evaluate the efficacy of this intervention, the principal~     aim of the phase of evaluations is to quantify the behavior changes in the three~     groups/populations mentioned. The evaluation has been designed according to the controlled~     intervention model, in which twenty-four schools from the Community of Madrid will be~     randomized to implement the Program si! for Preschool Education or to function as control~     schools.~   "
151778|NCT01579695|"~     The purpose of this observational, 10-year, prospective cohort study is to assess the~     potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with~     abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.~   "
151779|NCT01579682|"~     Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric~     disorder. The most promising treatment for adolescents with AN is family-based treatment~     (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up.~     Consequently, providing an alternative therapy early in the treatment course for those not~     responding to FBT may enhance overall outcome. This study aims to develop a new treatment -~     Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged~     12-18 years, who do not show an early response to FBT.~   "
151780|NCT01579669|"~     The goal of this proposal is to develop and evaluate patient-centered care tools for autistic~     adults and their primary care providers (PCPs).~   "
151781|NCT01579656|"~     Consumption of whole grains has been heavily endorsed by both government and major health~     agencies, as evidenced in Health Canada's Food Guide, the US Department of Agriculture's Food~     Pyramid, and the Heart and Stroke Foundation's healthy eating guide. Whole grains have been~     championed for their proposed cardioprotective and weight control effects as suggested by~     epidemiological studies. The health benefits of whole grain products may be attributable to~     their nutrient composition, which contains dietary fibre, protein and several essential~     nutrients. There has also been a concurrent increase in seed consumption. Seeds have a~     similar and potentially superior nutritional composition to whole grains and they are rich in~     mammalian lignans and polyunsaturated fats, especially the highly valued omega-3 fatty acids.~     Preliminary studies on seeds have shown that they impart health benefits similar to those~     imparted by whole grains. Consumer choices regarding seed consumption may be based on their~     potential health benefits. Furthermore, they may also be affected by subjective sensory~     factors, such as appearance, taste and pre-conceived perceptions. Therefore, this study will~     compare the health properties of four seeds and their effects on appetite and sensory~     parameters in healthy individuals. These four seeds will be that of flax, poppy and sesame,~     due to their popularity and consumption as well as Salba, which has also recently received~     much attention for its associated health benefits.~   "
151782|NCT01579643|"~     The primary goal of the trial is to determine if laser-assisted lamellar anterior~     keratoplasty (LALAK) will reduce the risks of post-operative complications such as adhesions,~     glaucoma and cataract that are associated with pediatric penetrating keratoplasty (PK).~   "
151783|NCT01579630|"~     The study aims to randomize 52 patients with advanced (Stage IV) EGFR mutation negative~     nonsquamous non-small cell lung cancer (NSCLC) who respond (CR/PR/SD) to 4 cycles of~     pemetrexed / cisplatin or pemetrexed/carboplatin as first-line therapy. In order to achieve~     that, approximately 144 treatment naïve patients with advanced nonsquamous NSCLC need to be~     enrolled from around 6 investigational sites in Taiwan that have expertise in lung cancer~     diagnosis.~   "
151784|NCT01579617|"~     The purpose of this study is to evaluate the efficacy of an online pregnancy prevention~     intervention that was adapted from the evidence based small group intervention SiHLE.~   "
151785|NCT01579604|"~     The cervical spine is most commonly injured, accounting for 53.4% of spinal injuries. More~     than 40% of all spinal injuries occur at either C4, C5 or C6 levels leading to variable loss~     of function in the upper extremities.~      Traditionally, patients sustaining a cervical spine injury were followed for 2 years to~     ensure that recovery had stabilized before offering upper extremity reconstruction. This type~     of reconstruction includes active muscle transfer, tendon transfer and joint fusion.~      Patients are most commonly assessed immediately at the time of injury. Muscle testing is~     commonly performed using Medical Research Grading System (MRC).~      Although complete neurologic stabilization may not be complete until 2 years post-injury, in~     the group with initial grade 0 muscle strength after the acute phase of injury, expectations~     of improved muscle strength to or beyond grade 3 after 4-6 months is minimal. And grade 3~     muscle strength is felt to be the minimum useful functional strength in a muscle group.~      The investigators propose an early nerve reconstruction approach to the tetraplegic patient~     with dysfunction of the upper extremity to augment the available tendon transfers.~      A comparative pilot study is proposed to determine the effectiveness of supinator branch to~     posterior interosseous nerve (PIN) transfer in 5 patients with cervical spine injury. Patient~     who fits inclusion criteria will be offered the opportunity to be involved in the study and~     reviewed at 6 months from injury. If the patient still has not regained Grade 3 power in~     finger or thumb extension, they will be randomized to be in a surgical group or non-surgical~     group.~      If informed consent is obtained, then surgery will be completed between 6-9 months from the~     patient's original cervical spine injury. The patient will be followed at regular intervals~     post-operatively with expectation of 18-24 month follow-up.~      Measures will be used pre and post-operatively for comparison. Measures will include MRC~     muscle grade (EDC), range of motion, Disability of the Arm, Shoulder, and Hand Questionnaire~     (DASH), and The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)~     (Kalsi-Ryan, 2011).~   "
151786|NCT01579591|"~     This is a randomized, double-blind, placebo-controlled phase III study involving 160 patients~     designed to assess the efficacy of the high potency probiotic preparation VSL#3® versus~     placebo in increasing the pathological major response rate in patients undergoing concurrent~     CT and pelvic RT.~   "
151787|NCT01579578|"~     The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus~     paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal~     junction, cancer.~   "
156679|NCT01515358|"~     The purposes of this study are to determine the safety and side effects of LY3000328, to~     determine how well the body will tolerate LY3000328, and to determine how long LY3000328~     remains in the body.~   "
151789|NCT01579552|"~     The purpose of this study is to empower women to improve their health in two very important~     areas: breast and heart health. This twelve-month study will compare two methods of informing~     participants about potential health risks and ways to stay healthy.~      The EMPOWER Study has been designed for adult women who were treated for a childhood cancer~     with chest radiation.~   "
151790|NCT01579539|"~     Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye~     disease, is a common orbital disease in adults. Patients with TAO, especially in its active~     phase, often complain about symptoms of ocular surface discomfort, including excess tearing,~     gritty sensation, increased sensitivity to light and foreign-body sensation, which are~     similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete~     blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear~     evaporation, which increases the tear fluid's osmolarity, and results in ocular surface~     damage. The administration of intravenous glucocorticoids can be an effective treatment for~     TAO.~      The rationale of the present study is to assess the effect of intravenously administered~     glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement~     of tear film thickness, tear film osmolarity and scattering of the tear film and well~     established methods for assessment of the severity of DES. Additionally, impression cytology~     and determination of tear cytokines/chemokines will be performed to obtain information about~     inflammatory processes on the ocular surface.~   "
151791|NCT01579526|"~     The purpose of this study is to determine the safety and pharmacokinetics of FP01 in healthy~     volunteers.~   "
151792|NCT01579513|"~     Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart~     surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent~     inflammatory response secondary to the body's recognition of the abnormal environment of the~     heart-lung machine. This inflammatory response may lead to poor heart, lung and kidney~     function after the heart surgery. This is turn can lead to longer times on the ventilator~     (breathing machine), the need for higher doses of heart medications, a longer stay in the~     intensive care unit and even death. This is particularly true in infants less than one month~     of age due to their size and the immaturity of their organs. The appreciation of the~     post-cardiopulmonary bypass inflammatory response has resulted in a number of interventions~     directed at its reduction. No therapy has been recognized as the standard of care; however~     steroid therapy has been applied most often despite unclear evidence of a benefit. This study~     aims to determine if steroids improve the outcomes of babies undergoing heart surgery.~   "
151793|NCT01579500|"~     The purpose of this study is to determine whether botulinum toxin A is effective in the~     treatment of neuropathic pain in spinal cord injury patients.~   "
151794|NCT01579487|"~     This study is being performed to follow up on subjects who participated in the initial study~     (ZA10-001) in 2010.~   "
151795|NCT01579474|"~     The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24~     weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1~     hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients~   "
151796|NCT01579461|"~     The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with~     mild and moderate hepatic impairment compared to healthy subjects.~   "
151797|NCT01579448|"~     Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection~     over 3 years and data regarding the protective efficacy over five years is anticipated for~     2012. Regardless at the end of five years, it may still be necessary to provide a booster~     dose or reimmunize with two doses to maintain protection in previously immunized populations.~     This study examines the immune protection and safety of providing a one and two dose boosting~     regimen of Shanchol™ given five years after the initial dose.~   "
151798|NCT01579435|"~     The purpose of this study is to determine whether transcranial direct current stimulation~     (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to~     identify the cerebral mechanisms involved in these potential effects.~   "
151799|NCT01579422|"~     The primary aim of this proposal is to develop, refine, manualize and assess the feasibility~     and preliminary efficacy of a brief, narrowly-focused social cognitive intervention for~     individuals with psychosis. The intervention will focus on helping individuals interpret~     social situations, specifically the intentions and feelings of others.~      Study methods include preliminary treatment and manual development based on series of~     uncontrolled cases, manual refinement, and a small feasibility/efficacy trial of the newly~     developed intervention.~   "
151800|NCT01579409|"~     In France, primary cardiovascular and metabolic prevention is supported by the French~     National Program for Nutrition and Health (PNNS: Programme National Nutrition Santé).~      The investigators made the hypothesis that, independently of other diseases, the non~     adherence in PNNS guidelines would lead to arterial stiffness, endothelial dysfunction,~     change in microcirculation and in cardiac autonomic system. These changes may exist at~     fasting but also be reinforced after a standardised breakfast.~      The investigators aim is to evaluate arterial stiffness, endothelial function,~     microcirculation and cardiac autonomic system according to PNNS status in a case control~     study.~   "
151801|NCT01579396|"~     A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with~     incidence of systemic inflammatory response syndrome (SIRS) and associated increased risk~     for acute kidney injury (AKI). Hypothesis: The high cut off dialyzer (septeX) can increase~     the postoperative IL-6/Il-10 ratio.~   "
151802|NCT01579383|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous~     injection.~   "
151803|NCT01579370|"~     Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for~     the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant~     (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter~     study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of~     enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of~     environmental contamination on acquisition of MDR-pathogens among hospitalized patients.~   "
151804|NCT01579357|"~     The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on~     the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen~     is given combined with Oxaliplatin (OxPt).~   "
151805|NCT01579344|"~     The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid~     carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy~     and metastases. Although serious complications are uncommon after treatment, there are~     well-documented adverse reactions secondary to the involvement of the salivary glands, such~     as dry mouth, pain in the parotid glands and dysphagia, even after administration of low~     doses of radioiodine. However, ocular complications of such treatment are scarcely reported~     in literature.~      Among them the investigators can mention recurrent and chronic conjunctivitis,~     keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive~     iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially~     after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction~     have been reported as complications associated with the use of radioiodine, although studies~     are not available to assess its true incidence through the systematic evaluation of patients.~      It can be seen in routine practice that these patients would normally be referred for~     ophthalmological examination only if a complaint, what happens in the process of OVL already~     installed after the use of high doses of radioiodine. With the early evaluation of these~     patients, the investigators focused on detecting the process of ongoing obstruction in order~     to study interventions that prevent its final installation.~   "
151806|NCT01579331|"~     Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular~     pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be~     compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the~     gold standard technique.~   "
151807|NCT01579318|"~     A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor~     activity of ImmunoPulse IL-12® in participants with stage IB to IIIB mycosis fungoides.~     ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as~     tavokinogene telseplasmid [tavo]) and in vivo electroporation-mediated plasmid~     deoxyribonucleic acid [DNA] vaccine therapy (tavo-EP) administered using the OncoSec Medical~     System (OMS).~      All participants may receive up to four cycles of treatment consisting of three treatment~     days, Days 1, 5 and 8, in a 12-week cycle as per Protocol version 6 (see Limitations and~     Caveats section of this record for protocol version information). Patients will receive~     intra-tumoral injection of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day~     distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor~     site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.~   "
151808|NCT01579305|"~     The purpose of this study is evaluate lip fullness 3 months following treatment with~     Juvéderm® Volbella with Lidocaine or Restylane-L®~   "
151809|NCT01579292|"~     The goals of the study are to:~        1. Assess effect sizes of our mDPP intervention on weight loss, physical activity, dietary~          intake, and fasting plasma glucose (FPG) levels from baseline to 5 months as compared to~          a control group.~        2. To explore the association between low heath-literacy levels at baseline and adherence~          to mobile phone usage.~        3. To conduct process evaluation to gain insights into patient compliance to the mobile~          intervention, including usage barriers and acceptability of our mDPP, at 1 and 5 months~          using a semi-structured interview method.~   "
151810|NCT01579279|"~     To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic~     neuropathic pain. People with diabetes can, over time develop nerve damage throughout the~     body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms,~     feet and legs.~   "
151811|NCT01579266|"~     Background:~      - People with writer s cramp develop tightness in arm muscles and abnormal hand posture when~     writing, which makes writing difficult or impossible. At present, there is no suitable rating~     scale to measure the symptoms of or disability associated with writer s cramp. Researchers~     want to videotape people performing simple writing tasks. They will then compare the~     performance of people with writer s cramp on these tasks to those of people without writer s~     cramp. This information will help develop a rating scale to evaluate writer s cramp.~      Objectives:~      - To develop a new rating scale for writer s cramp.~      Eligibility:~      - Individuals at least 18 years of age who have writer s cramp.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have one outpatient study visit that will last about 3 hours.~        -  Participants will perform tasks related to writing, such as writing passages and drawing~          spirals and loops. They will be videotaped during these tasks. They will repeat some of~          the writing tasks three more times; on paper attached to a writing tablet, directly on~          the writing tablet, and on a computer tablet.~        -  The angles made by the joints will be measured at rest not while writing~      healthy volunteers.~   "
151812|NCT01579253|"~     Patients with recurrent glioblastoma who are planned to receive a second course of radiation~     are to be included into this monocentric cohort trial. Due to multiple pre-treatments~     simultaneous combined positron emission tomography (PET) with~     O-(2-[18F]fluoroethyl)-l-tyrosine (FET) as well as magnetic resonance imaging (MRI) is used~     for treatment planning and follow-up imaging as it allows for a better distinction between~     treatment-related changes and viable tumor tissue.~   "
151813|NCT01579240|"~     This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older~     adults adopt and maintain an exercise regimen. A total of 368 men and women over 55 years of~     age (x = 60.3; SD 4.9 ) were recruited and screened on line. They randomized into treatment~     and control groups and assessed at pre-test, 12 weeks, and at six months.~      The multivariate model was significant at posttest (p = .001; large effect size) and at six~     months (p = .001; medium effect size). At posttest, intervention participation showed~     significant improvement on 13 of 14 outcome measures compared to the control group. At six~     months, treatment group participants were found to maintain large gains compared to the Ctrl~     participants on all 14 measures.~   "
151864|NCT01578577|"~     Many patients have difficulty performing routine medication management tasks. Individuals~     with limited literacy are at high risk for these problems. The overall study objective is to~     rigorously evaluate two primary care-based medication therapy management strategies that~     leverage an electronic health record (EHR) to promote patient understanding, medication~     reconciliation, medication adherence and disease control among hypertensive patients at~     safety net clinics.~   "
178435|NCT01229423|"~     This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the~     augmentation of eyelashes in Korean women.~   "
151814|NCT01579227|"~     The following two objectives are proposed in healthy subjects to characterize (1) wound~     closure, (2) scar formation/appearance, and (3) inflammatory response:~      Objective 1, (topical only - referred to as TOP) - Topical application of Tocotrienol (TCT)~     vs placebo in bilateral punch biopsy~      Objective 2, (oral and topical - referred to as OTOP) - Combined oral supplementation and~     topical application of tocotrienol (TCT) vs placebo in bilateral punch biopsy~      Objective 3, (topical only - referred to as TAM) - Topical application of tamoxifen vs~     placebo in bilateral punch biopsy.~      Objective 4, (topical only to normal skin) - Topical application of TCT vs placebo on~     bilateral lets on normal skin.~   "
151815|NCT01579214|"~     The investigators will study the efficacy of a novel cellular phone messaging system to~     communicate health information and facilitate early return to clinic after abnormal~     laboratory results in rural Uganda.~   "
151816|NCT01579201|"~     The purpose of this trial is to determine the effective dose of carbetocin which would~     prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective~     cesarean delivery.~   "
151817|NCT01579188|"~     The purpose of this study is to evaluate survival in inoperable stage III Non-small Cell Lung~     Cancer patients following chemo-radiotherapy followed by GV1001 vaccination plus best~     supportive care.~   "
151818|NCT01579175|"~     The investigators are randomizing patients to receive chewing gum (Extra Sugar Free,~     Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative~     care. The investigators then have them fill out a survey in house and 1 week after their~     surgery that record time to first flatus, hunger, toleration of clear liquids and food and~     some information about pain, satisfaction, and quality of life. The investigators contact~     them via phone and email a maximum of three times in order to collect this information. 30~     days postoperatively the investigators also contact them and perform a chart review for any~     postoperative complications.~   "
151819|NCT01579162|"~     HepQuant tests are new liver tests that are being developed to accurately measure liver~     function with sensitivity and specificity while being safe and non-invasive. The primary goal~     of this study is to define the intra-individual reproducibility of the HepQuant tests, that~     is, to see if a person is given the tests several times that the test results are essentially~     the same each time. Subjects for this study will include healthy controls and patients with~     chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV)~     infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis~     (NASH). The HCV and NASH patients will include men and women, and those with early stage and~     late stage liver disease as defined by the amount of fibrosis observed in their liver~     biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests~     on three separate days within the span of one month. The hypothesis of this study is that~     HepQuant tests will reproducibly report liver function in healthy controls and patients with~     all stages of chronic HCV and NASH liver disease and that liver function will decrease as the~     amount of liver fibrosis increases in the chronic liver disease patients.~   "
151820|NCT01579149|"~     The primary objective is to assess the pharmacokinetics of 3 dose levels of plerixafor~     injection (160 μg/kg, 240 μg/kg, and 400 μg/kg) in healthy adult subjects of Japanese~     descent. Three cohorts of subjects will be enrolled. Approximately 8 subjects will be~     enrolled in each cohort, 6 subjects who will receive a single subcutaneous (SC) dose of~     plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg), and 2 subjects who will receive a single SC~     dose of placebo. The lowest dose-level cohort (plerixafor 160 μg/kg) will be fully enrolled~     first, followed by the next highest dose-level cohort (plerixafor 240 μg/kg), and finally the~     highest dose-level cohort (plerixafor 400 μg/kg), provided safety criteria for dose~     escalation are met.~   "
151821|NCT01579136|"~     The purpose of this study is to determine if home blood pressure monitors can help decrease~     blood pressure in patients with diabetes at a low income clinic.~   "
151822|NCT01579123|"~     The reason the investigators are doing this study is to compare the results of laser~     atherectomy versus angioplasty with or without the placement of a stent in the artery. A~     stent is a metal tube used to open up narrow arteries in the body.~   "
151823|NCT01579110|"~     The purpose of this study is to determine whether Levamisole plus prednisone can further~     improve the efficacy，extend the remission duration and reduce the dosage of prednisone for~     newly diagnosed warm antibody autoimmune hemolytic anemia.~   "
151824|NCT01579097|"~     The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared~     to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in~     hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or~     contraindicated.~   "
151825|NCT01579084|"~     This study will evaluate the safety and tolerability of AGN-199201 for the treatment of~     erythema associated with rosacea.~   "
151826|NCT01579071|"~     Insufflation is essential procedure to observe the lumen of gastrointestinal tract in~     gastroscopy or colonoscopy Currently, most of hospital in Korea are using room air for~     insufflation According to recent clinical studies have shown that carbon dioxide have better~     safe and reduce stomachache than room air when endoscopy and endoscopic procedure is~     performed.~      However, there was still no research data or study in Korea. In this study, the investigators~     will try to make comparison between Carbon dioxide and room air insufflation for endoscopic~     submucosal dissection for Gastric Tumor and investigate the efficacy and safety~   "
151827|NCT01579058|"~     Aortic stenosis has been thought to be a degenerative process basically induced by~     long-lasting mechanical stress, and hemodynamic factors such as shear forces, acceleration of~     blood flow, hypertension and rapid heart rate might contribute to progression of aortic~     stenosis. Peak aortic jet velocity is known to be associated with clinical outcomes in mild~     and moderate AS, and our previous study showed that rate of progression was significantly~     associated with baseline aortic jet velocity in mild aortic stenosis. Because beta-blocker~     therapy would decrease aortic jet velocity and heart rate, it might decrease hemodynamic~     stress and eventually slow down the degenerative process in patients whose disease is not too~     advanced for therapy to be effective. The investigators hypothesized that a beta-blocker~     therapy would decrease the rate of progression of aortic stenosis by modifying hemodynamic~     factors favorably in patients with mild to moderate aortic stenosis.~   "
160148|NCT01469871|"~     The purpose of this study is to determine if one of the new types of dressings (MEPORE PRO~     and/or MEPILEX BORDER ) will reduce the blister rate compared to the currently used HYPAFIX.~   "
151828|NCT01579045|"~     Primary Hypotheses:~      Senofilcon A will provide significantly less rotation with subjects in a recumbent position~     than Filcon II 3 monthly .~      Etafilcon A will provide significantly less rotation with subjects in a recumbent position~     than Filcon II 3 1 1 day .~      Etafilcon A will provide rotation with subjects a recumbent position non-inferior to~     nelfilcon A. A margin of 5 degrees will be used.~      Secondary Hypotheses:~      Senofilcon A will have significantly better monocular visual performance with subjects in a~     recumbent position than Filcon II 3 monthly.~      Etafilcon A for astigmatism will have significantly better monocular visual performance with~     subjects in a recumbent position than Filcon II 3 1 day.~      Etafilcon A will have monocular visual performance with subjects in a recumbent position~     non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.~   "
151829|NCT01579032|"~     The aims of the presented study are as follows:~        1. To evaluate the endothelial function and arterial stiffness in a large cohort of~          prevalent CKD patients by means of non-invasive applantion tonometry.~        2. To evaluate the association between the serum levels of the representatives of the~          various classes of uremic toxins and markers of endothelial function and arterial~          stiffness.~        3. To evaluate the association between markers of inflammation and oxidative stress and~          markers of endothelial function and arterial stiffness.~        4. To evaluate the association between echocardiographic parameters and markers of arterial~          stiffness~   "
151830|NCT01579019|"~     This randomized, double blind, phase II study will evaluate the efficacy and safety of two~     doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys~     (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease~     inhibitor containing regimen with or without pegylated interferon. Patients will be~     randomized to receive either a 2-week lead-in of RO5024048 (1500 mg or 1000 mg orally twice~     daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or~     1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with~     danoprevir (100 mg orally twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys~     and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with~     danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on study~     treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.~   "
151831|NCT01579006|"~     This multi-center, observational study will evaluate the clinical practice patterns, efficacy~     and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had an~     inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one~     biological agent. Data will be collected from each eligible patient initiated on~     RoActemra/Actemra treatment by their treating physician according to approved label for 6~     months from start of treatment.~   "
151832|NCT01578993|"~     The purpose of this study is to determine the rate and timing of interventions and~     complications related to the use of peripherally inserted central venous catheters in adult~     patients.~   "
151833|NCT01578980|"~     A single arm, single treatment study is proposed to assess the feasibility of the AP Platform~     (cell phone + Control to Range system) outside of a hospital based clinical research center.~   "
151834|NCT01578967|"~     The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4~     chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of~     cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In~     addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive~     radiation therapy. The use of chemotherapy and radiation may cause long term treatment~     related side effects such as heart problems and other cancers. Researchers are trying to find~     if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy~     cycles given is just as effective as the standard Hodgkin treatment.~      Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for~     the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the~     use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational.~     Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it.~     Antibodies are proteins that are part of your immune system. They can stick to and attack~     specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target~     called cluster of differentiation antigen 30 (CD30). CD30 is an important molecule on some~     cancer cells and some normal cells of the immune system.~      The purpose of this research study is to see the effects of treatment with fewer cycles of~     the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on~     study participants and Hodgkins lymphoma.~   "
151835|NCT01578954|"~     The purpose of this research study is to test the safety of the study drug, lenalidomide, at~     different dose levels in people diagnosed with acute myeloid leukemia (AML) who have finished~     standard induction therapy and have had a partial or complete response to induction therapy.~     The investigators want to find out what effects (for example, side effects) the study drug,~     lenalidomide, has on people and their leukemia. The investigators also want to see if~     additional treatment (maintenance therapy) with lenalidomide will keep the leukemia from~     relapsing (coming back).~   "
151836|NCT01578941|"~     The study is to primarily investigate whether Treximet® (Imitrex RT/naproxen sodium 500mg)~     taken at the first onset of menstrual migraine will both terminate the acute headache and~     assist in preventing headache recurrence and the need for repeat abortive therapy over the~     ensuing days of menses.~   "
151837|NCT01578928|"~     The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics~     (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal~     impairment.~   "
151851|NCT01578746|"~     In total hip arthroplasty several approaches can be used. The newly introduced minimally~     invasive anterior approach is supposed to cause less damage to tendons and muscles. At the~     same time there are reports that there are more complications when this approach is used. The~     direct lateral approach is the most used in Norway and is well documented. There are however~     those who postulate that there is to high risk of damage to the gluteus medius causing~     Trendelenburg gait. In the investigators hospital both the anterior and direct lateral~     approach is used with good result. The investigators main study hypothesis is that there is~     no difference between the use of anterior or direct lateral approach i total hip arthroplasty~     in regards to postoperative function and pain, complications, radiological finds (X-ray and~     MRI), markers for muscle damage (i.e CK-total) or other clinical outcomes.~   "
151838|NCT01578915|"~     Both population based surveys and more focused research studies indicate that increased~     numbers of sexual partners and partner concurrency contribute to increased risk for~     acquisition of sexually transmitted infection (STI), including HIV infection. However, unlike~     for men, both national and sub-population-based studies consistently find that the great~     majority of women with or without STIs report only 1-2 sex partners in the preceding year and~     that a minority of women acknowledge > 3 sex partners over the same period, suggesting that~     this relatively small proportion of women with higher numbers of sex partners play a~     disproportionate role in sustaining community STI rates. Despite these observations,~     surprisingly little is known about women with increased numbers of sexual partners, the~     factors which contribute to increased partner number, and the potential for those factors to~     be intervened upon to reduce risk for STI. The implications of these facts for STI/HIV~     prevention efforts are profound. For instance, interventions that include the implication~     that target audiences have multiple sex partners might be dismissed as irrelevant by those~     with single partners. Conversely, interventions targeting women with multiple sex partners~     may be based on assumptions derived from data which, while representative of the general~     target audience, may not reflect relevant circumstances for the subset of women with higher~     numbers of partners.~      This study will begin to generate data that will provide critical information on this topic~     and help inform future development of STI/HIV interventions tailored to womens' individual~     circumstances and contexts. The investigators hypothesize that women with 4 or more sexual~     partners during the past year will report higher rates of depression and substance abuse~     (alcohol and drugs), higher rates of intimate partner violence, less social support, more~     non-vaginal sex, more same-sex contacts, and higher rates of STIs than women reporting only~     one sexual partner during the past year.~   "
151839|NCT01578902|"~     The purpose of this study is to determine the safety and efficacy of a short course of~     radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.~   "
151840|NCT01578889|"~     Some vaccines may work better when given together with another substance known as an adjuvant~     or when given with an experimental procedure called electroporation (EP). EP is a method~     where an electric pulse is administered to the same muscle where the vaccine injection is~     given. The addition of the adjuvant to the vaccine and the delivery with EP may increase a~     person's immune response to the vaccine. Combination approaches such as a DNA vaccine~     followed by live vector boost may also increase a person's immune response to the vaccine~     components. All of these interventions will be tested in this study.~      This study will evaluate the safety and tolerability of and immune response to an HIV DNA~     vaccine with or without plasmid IL-12 adjuvant, when given by EP and followed by a live~     vector vaccine given IM by needle and syringe in healthy, HIV-uninfected adults.~   "
151841|NCT01578876|"~     The purpose of this study is to determine the effectiveness of cardiac shock wave therapy~     (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort.~   "
151842|NCT01578863|"~     The child health and sports center, at the Meir Medical Center, runs for over 10 years an~     intervention program to treat obese children. The program includes physical activity,~     nutritional intervention and behavioral treatment. A similar program exists in the nearby~     city of Hadera. The aim of the programs is to promote weight loss, encourage physical~     activity and modify behavior in order to get long term results. The aim of the present study~     is to try and identify the demographic and behavioral characteristics of children who succeed~     in the program.~   "
151843|NCT01578850|"~     To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly~     plus methotrexate with or without other disease modifying antirheumatic drugs therapy with~     that of methotrexate with or without other disease modifying antirheumatic drugs therapy at~     Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved~     low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly~     plus MTX with or without other disease modifying antirheumatic drugs therapy.~   "
151844|NCT01578837|"~     The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind~     randomized placebo controlled trial. The objective is to investigate whether the combination~     of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are~     effective and safe in the long-term management of high blood pressure while managing type 2~     diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key~     inclusion criteria: HbA1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.~   "
151845|NCT01578824|"~     Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in~     exhaled breath condensate in vitamin D resistant rickets.~      Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and~     inflammatory mediators in exhaled breath condensate in a prospective study evaluating~     patients with vitamin D resistant rickets and in healthy controls.~      Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as~     assessed by methacholine challenge test.~      Secondary outcome parameters: All other parameters are the secondary end points.~   "
151846|NCT01578811|"~     The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With~     acute and chronic gastritis.~   "
151847|NCT01578798|"~     Surgical trauma triggers a massive inflammatory response. Over time, both the innate and~     adaptive branches of the immune system are affected by surgical trauma. The purpose of this~     study to characterize the cellular and molecular mechanisms immune response to surgical~     trauma. Additionally, detailed information about patients' recovery profile will be recorded~     over a period of 6 weeks, with the eventual goal of linking immune responses to recovery~     profiles.~   "
151848|NCT01578785|"~     This study will investigate the efficacy, safety and tolerability of a new formulation of~     glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with~     Relapsing-Remitting Multiple Sclerosis (RRMS).~   "
151849|NCT01578772|"~     This research study is to see whether blood vessel function, an early sign of heart disease,~     improves in HIV-infected men and women who take telmisartan for 12 weeks. The investigators~     will be looking at how a blood vessel in the arm, called the brachial artery, changes in~     response to stress before and after taking telmisartan. To determine how well the blood~     vessel functions, the investigators will be using an ultrasound machine.~      Telmisartan is not an HIV medication. It is an FDA-approved medication designed to treat~     blood pressure, but has been shown to improve blood vessel function in HIV-negative people~     with and without high blood pressure. Telmisartan is made by Boehringer Ingelheim, and this~     trial is sponsored by The Campbell Foundation.~   "
151850|NCT01578759|"~     The purpose of this study is to assess the feasibility of performing a randomized clinical~     trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during~     laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes~     can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled~     tubes)and additional invasive procedures such as further imaging work-ups and further surgery~     related to the tubes.~   "
151852|NCT01578733|"~     Minimal data are available on protein requirements throughout the lifespan. Currently~     available recommendations are based on nitrogen balance data. The limitations of the nitrogen~     balance method have been well described. Importantly, nitrogen balanced underestimates~     requirements.~      The current DRI requirement for healthy adult males is based on the reanalysis of the~     nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by~     Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83~     (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group~     estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2~     g/kg/day (mean and RDA).~      Currently there are no studies on protein requirement in the elderly. In a recent nutrition~     survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70~     years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents~     about 15 % of calories. Depending on the calculations used for ideal body weight some older~     adults could be getting higher or lower than requirement. There is no scientifically derived~     protein estimate for older adults. Therefore there is a need to measurer protein requirement~     in that population.~      The goal of this study therefore is to measure the protein requirement of female elderly~     subjects between the ages of 65 - 70 years using the IAAO technique.~   "
151853|NCT01578720|"~     The purpose of this study is to assess the efficacy and safety of intravitreal injection of~     aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed~     ocular histoplasmosis syndrome (POHS).~   "
151854|NCT01578707|"~     The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy~     results in a clinically significant improvement in progression free survival (PFS) as~     compared to treatment with ofatumumab in patients with relapsed or refractory Chronic~     Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)~   "
151855|NCT01578694|"~     Magnetic resonance imaging (MRI) has proven to be one of the best ways to image articular~     cartilage. A tremendous amount of research has focused on cartilage imaging with an emphasis~     of early-osteoarthritis (OA) characterization. One of the techniques which has shown great~     promise is the imaging technique called T1ρ . The advantage of this pulse sequence is that it~     is sensitive to proteoglycans (PG), a major macromolecule degraded in OA. The study objective~     is to determine if T1ρ can acutely assess PG content in femoroacetabular impingement (FAI)~     which may allow physicians to differentiate between normal and early-OA cartilage states in~     FAI patients.~   "
151856|NCT01578681|"~     The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.~      Primary objective:~      -To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to~     placebo.~      Secondary objectives:~        -  To evaluate the level of knowledge of airway clearance techniques and adherence to them~          in patients with bronchiectasis.~        -  To assess the side effects during the procedure: oxygen desaturation, increased dyspnea~          and hemoptysis.~   "
151857|NCT01578668|"~     The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are~     effective and safe in treating lung adenocarcinoma with brain metastases.~   "
151858|NCT01578655|"~     This Phase 3 study has been designed to confirm that adding custirsen to~     cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes~     compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate~     resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter,~     international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs.~     cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal~     probability to the two arms.~   "
151859|NCT01578642|"~     The EndoStim Stimulation System is an investigational device intended to improve the lower~     esophageal sphincter (LES) resting tone and restore LES function in individuals suffering~     with gastroesophageal reflux disease (GERD).~   "
151860|NCT01578629|"~     A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as~     barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and~     lowers cholesterol, which make it a potential therapy for stroke prevention, though these~     effects are less well characterized for TCT. We plan to conduct two trials (I & IIA) to~     determine the effects of orally supplemented TCT on platelet function and cholesterol.~   "
151861|NCT01578616|"~     Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability.~     The high resolution of optical coherence tomography (OCT) provides an accurate measurement of~     fibrous cap thickness. Endothelial dysfunction is a key component of vulnerable plaque and~     digital reactive hyperemia-peripheral arterial tonometry (RH-PAT) is a non-invasive automatic~     and quantitative method to evaluate endothelial function. The investigators will investigate~     the association between endothelial function assessed by RH-PAT and plaque vulnerability~     determined by OCT-derived thin-cap fibroatheroma (TCFA).~   "
151862|NCT01578603|"~     The purpose of this study is to determine the effect of three times a day mastication, during~     a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors~     associated with dental caries and gingivitis.~   "
151863|NCT01578590|"~     Rationale: The consumption of dietary protein immediately after exercise is necessary to~     maximally stimulate muscle protein synthesis rates (24, 37). Recent work suggests that the~     type of protein consumed (e.g., animal vs. plant-derived proteins) during post-exercise~     recovery can affect the amplitude of acute increases in muscle protein synthesis rates (25,~     31). Specifically, consumption of bovine milk proteins immediately after a single bout of~     resistance exercise stimulates muscle protein synthesis rates greater than consumption of an~     isonitrogenous soy-protein beverage (31, 37). Importantly, consumption of milk promotes~     greater hypertrophy than soy after resistance training (10). Thus, it is generally assumed~     that the acute muscle protein synthetic response predicts long-term training outcomes, such~     as hypertrophy. Currently, a great amount of work has been carried out to study the effects~     of consuming milk proteins on muscle protein synthesis rates after resistance exercise (5, 7,~     26, 32). However, very little is known about the effects of other types of high-quality~     animal proteins, such as beef, on stimulating post-exercise muscle protein synthesis rates.~     Further describing the muscle protein synthetic response after consumption of other types of~     high-quality animal proteins will provide valuable information for individuals with milk~     allergies, lactose intolerance, or simply a strong dislike of dairy products.~      Objective: To investigate whether the in vivo post-resistance exercise muscle protein~     synthetic response is augmented when minced beef is ingested as compared to an~     isonitrogenous-matched milk protein beverage in healthy young men.~      Study design: Crossover, randomized~      Study population: 12 healthy young males (18-35 y).~      Intervention: Subjects will perform resistance exercise and consume either a piece of meat~     (135 grams, 35 g of protein) or an isonitrogenous-matched milk protein beverage on two~     separate test days. In addition, continuous intravenous tracer infusions will be applied,~     with plasma and muscle samples collected. A two week 'wash-out' period will be included~     between trials.~      Main study parameters/endpoints Primary endpoint: Muscle protein synthetic rate, expressed as~     fractional synthetic rate (FSR). Secondary endpoints: Rate of protein digestion and~     absorption and whole body protein balance.~   "
151870|NCT01578499|"~     The purpose of this study is to determine objective response rate (ORR), lasting at least 4~     months (ORR4), with brentuximab vedotin in participants with cluster of differentiation~     antigen 30 positive (CD30+) cutaneous T-cell lymphoma [mycosis fungoides (MF) and primary~     cutaneous anaplastic large cell lymphoma (pcALCL) ]compared to that achieved with therapy in~     the control arm.~   "
151871|NCT01578486|"~     This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15~     schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive~     functioning, and metabolic parameters.~      Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or~     Massachusetts General Hospital. A total of 15 subjects will be enrolled.~   "
151872|NCT01578473|"~     Two recent studies have identified low levels of serum testosterone in association with~     Peyronie's Disease (PD), with a significant correlation noted between severity of~     testosterone deficiency and severity of curvature. The study hypothesis is to determine~     whether treatment with testosterone may help men with PD and penile curvature.~   "
151873|NCT01578460|"~     Poor glucose control during pregnancy is a significant concern for Canadian women with~     diabetes. This problem is magnified in First Nations women, who have among the highest rates~     of gestational diabetes (GDM) in the world (up to 18% of First Nations women will develop GDM~     during pregnancy and 70% of these will go on to develop type 2 diabetes later). Continuous~     glucose monitoring (CGM) technology has the potential to help women maintain tighter control~     during pregnancy, however, in the First Nations population, there are many unique barriers~     that may affect use of this technology. Such barriers include remoteness of the community,~     cultural apprehension, lack or difficulty of access to care, and language differences.~      A total of 60 participants from three participating First Nations communities in Southern~     Ontario will participate in the study. Participants will self-select to either the CGM group~     (n=30) or the control group (n=30) after consenting to participate in the study. Participants~     in both groups will be asked to monitor their blood glucose for 5 days for the 28th, 32nd and~     36th week of gestation. Primary outcomes to be evaluated include maternal A1c and offspring~     birth weight. To assess the feasibility and acceptability of CGMs among First Nations women,~     a questionnaire will be distributed to participants to gather insight into their rationale~     for enrolling into either group. Recruitment rates for both groups will also be used to~     assess feasibility and acceptability of CGMs. Additionally, all participants will be~     encouraged to participate in a community lifestyle program consisting of 30-min exercise~     sessions offered five days a week. The community lifestyle program will be adapted to the~     community, linked to existing programs with support from program personnel and will include~     educational sessions related to diabetes and healthy lifestyles. It is hypothesized that~     through participation in the community lifestyle program, pregnant First Nations women with~     diabetes will experience a decrease in their blood glucose values post-exercise, mitigate~     excessive weight gain and normalize their A1c's. It is further hypothesized that an increase~     in women's regular physical activity levels, the number of steps taken and knowledge of~     diabetes will be observed.~   "
151874|NCT01578447|"~     The purpose of this study is to assess acceptability and side effects of a low-dose~     injectable contraceptive formulation which is delivered under the skin (subcutaneously), as~     compared with injectable contraception delivered into the muscle (intramuscularly) among~     adult HIV-positive women who attend mobile clinics for HIV care and wish to use injectable~     contraception. The investigators will also assess experiences experiences delivering these~     two types of injections among health care providers working within the HIV care clinics.~   "
151875|NCT01578434|"~     Rickets, a common nutritional disorder, is usually considered to be due to vitamin D~     deficiency. However, in the last few decades many studies have shown that in tropical~     countries, with abundance of sunshine, calcium deficiency may play a more important role in~     the causation of rickets. Studies from adults in India have also shown that calcium intake of~     our population is much below the recommended allowance. The calcium deficiency gets~     compounded by the high level of phytates in the conventional vegetarian diet consumed by the~     majority of the population. There are few studies on children in India / other Asian~     countries on assessment of dietary calcium intake.~      However, recent studies from many nations of the world have also shown a wide spread~     prevalence of vitamin D deficiency in adolescent and adult population. A study done at our~     own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and~     their infants.~      Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not~     clear what plays a more important role in the etiology of rickets in India or other Asian~     countries.~      The present study is therefore planned with the following objectives:~        1. To study the dietary calcium intake, sun exposure and serum vitamin D levels in children~          with and without rickets.~        2. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the~          treatment of nutritional rickets.~   "
151876|NCT01578421|"~     The purpose of the study is to compare clearance and removal rates of phosphate,~     ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during~     post-dilution online hemodiafiltration.~   "
151877|NCT01578408|"~     The purpose of this prospective randomized study is to compare the quality of treatment~     between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip~     Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.~      Our hypothesis is that an uncemented option spares the patient the operative load of the~     cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn also~     perhaps reduces the postoperative cognition strain and improves mobilization parameters.~      If the uncemented option has the same excellent fixation in poor bone stock, as in the case~     of these osteopenic fractures, and also has the same good clinical outcome, it would be a~     viable standard option for the treatment of dislocated femoral neck fractures.~   "
151878|NCT01578395|"~     Trial with medicinal products~      Recent studies revealed that radiation-based procedures in patients may lead to DNA~     double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human~     blood lymphocytes have shown a protective effect of antioxidant agents which have been~     described to decrease the number of DNA double-strand breaks.~      This study represents a prospective, double-blinded, randomized, single center, and~     placebo-controlled phase II clinical trial which analyzes the capability of antioxidant~     agents to decrease the number of DNA double-strand breaks in human blood lymphocytes in~     patients undergoing radiation-based cardiac examinations (30 patients with high-dose~     radiation exposure, 30 patients with low-dose radiation exposure, and 30 subjects without~     radiation exposure).~      A protective effect of antioxidant drugs in patients undergoing radiation-based examinations~     could therefore change patient management and would provide an important clinical impact.~   "
151879|NCT01578382|"~     Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction)~     which occurs in long-term hypertensive subjects.~      Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin~     infarction) which occurs in subjects with end-stage kidney disease or after kidney~     transplantation.~   "
151881|NCT01578356|"~     For primary surgical treatment of prostate cancer the investigators compare the classic open~     surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery~     (RALP). Oncological results are obtained at standard follow-up consultations through~     Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional~     results (continence, potency, quality of life) are obtained through standardised~     questionnaires. Currently the investigators perform all of their prostatectomies in a~     robot-assisted manner. For results of the open surgery the investigators send questionnaires~     to patients who had the operation in the past.~   "
151882|NCT01578343|"~     1. Rationale In mantle cell lymphoma, the conventional chemotherapy achieves only temporary~          responses with a median duration of remissions only from 1 to 2 years. Therefore, mantle~          cell lymphoma is known as one of the B-cell lymphomas with poor prognosis. Although the~          treatment outcome of mantle cell lymphoma has been improved since intensive chemotherapy~          regimens such as HyperCVAD was used, a substantial number of patients are still~          frequently relapsed after chemotherapy. After relapse, most of them became refractory to~          various kinds of salvage treatment. That is why the results of most salvage chemotherapy~          regimens were disappointing. In addition, mantle cell lymphoma generally occurs in~          elderly people. Thus, intensive salvage chemotherapy may not be feasible for elderly~          patients. Therefore, an effective, novel combination treatment is urgently needed in~          relapsed or refractory mantle cell lymphoma patients.~        2. Hypothesis~             -  Vorinostat will produce synergism with a combination treatment regimen~               (Fludarabine, mitoxantrone, dexamethasone, FND) without overlapping toxicity~             -  Vorinostat maintenance treatment will reduce the relapse rate in patients~               ineligible for autologous stem cell transplantation.~        3. Purpose A phase II investigation to determin the effectiveness of vorinostat in~          combination with intravenous fludarabine, mitoxantrone, and dexamethasone in patients~          with relapsed or refractory mantle cell lymphomain patients with relapsed or refractory~          mantle cell lymphoma.~   "
151883|NCT01578330|"~     The study will assess the patients' satisfaction of treatment after 12 months treatment with~     fingolimod It also will assess the tolerability profile of fingolimod in a small population.~   "
151884|NCT01578317|"~     Background:~      - Adjuvants are substances included in vaccines that stimulate the immune system and increase~     the body's response to the vaccine. The AS03 adjuvant is used in seasonal flu vaccines in~     Europe. However, it has not been fully tested in the United States. Researchers want to test~     the immune responses of people who receive a bird flu vaccine with or without AS03 to better~     understand how the adjuvant works. This information may help develop better flu vaccines.~      Objectives:~      - To compare the healthy immune system responses to bird flu vaccine with or without the AS03~     adjuvant.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will be assigned to one of two groups. Each group will have an initial~          vaccine, followed by a booster vaccine 21 days later. Both vaccinations will use the~          same type of vaccine. One group will have the vaccine with AS03; the other group will~          have the vaccine without it.~        -  All participants will have two 36-hour inpatient stays to receive the vaccine. Each stay~          will involve the vaccination, followed by regular and frequent blood draws. Participants~          will be monitored for any signs or symptoms that may be caused by the vaccine.~        -  Additional blood samples will be collected 7, 28, 42, and 100 days after the initial~          vaccination.~   "
151885|NCT01578304|"~     To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg~     b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary~     frequency associated with urgency as may occur in patients with overactive bladder.~   "
151886|NCT01578291|"~     Hypothesis: The use of parent education and medical play will be able to reduce patient~     discomfort with potential uncomfortable medical procedures.~      Children that have urinary tract infections and those diagnosed with vesicoureteral reflux~     undergo a procedure called a voiding cystourethrogram (VCUG) to identify and follow~     vesicoureteral reflux. For many children and parents this can lead to considerable distress.~     Pre-procedure preparation can potentially reduce anxiety and improve overall experience with~     the procedure.~   "
151887|NCT01578278|"~     This is a clinical study to evaluate the safety and efficacy of a bepotastine~     besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic~     rhinitis (SAR) in subjects with a demonstrated history of Mountain Cedar pollen allergy. The~     primary study objective is to assess the reduction from baseline in averaged morning (AM) and~     evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays~     (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate~     nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For~     enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with~     placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day~     with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for~     both nasal and ocular symptoms prior to each dosing.~   "
151888|NCT01578265|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult, human subjects.~   "
151889|NCT01578252|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult, human subjects.~   "
151910|NCT01577979|"~     In this project, the investigators will develop, implement, and evaluate an adolescent~     vaccination quality improvement program, with the program designed to encourage adolescents~     to visit their usual primary care provider to receive vaccinations and other recommended~     preventive health services. This study will be conducted in different types of primary care~     settings, such as public, private, and managed care clinics serving adolescent patients of~     diverse backgrounds, and will provide important information to help guide future public~     health efforts to achieve high rates of immunization in adolescents.~   "
151911|NCT01577966|"~     The main purpose of this part of the study is to determine the Central Nervous System~     bioavailability of sulfasalazine.~   "
151890|NCT01578239|"~     The purpose of this study is to~        -  compare Progression Free Survival (PFS) after treatment with 177Lu-DOTA0-Tyr3-Octreotate~          plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg)~          Octreotide LAR in patients with inoperable, progressive (as determined by Response~          Evaluation Criteria in Solid Tumors [RECIST] Criteria), somatostatin receptor positive,~          well-differentiated neuroendocrine tumours of the small bowel (midgut carcinoid~          tumours).~        -  compare the Objective Response Rate (ORR) between the two study arms~        -  compare the Overall Survival (OS) between the two study arms~        -  compare the Time to Tumour Progression (TTP) between the two study arms~        -  evaluate the safety and tolerability of 177Lu-DOTA0-Tyr3-Octreotate~        -  evaluate the health related quality of life (QoL) as measured by the European~          Organization for Research and Treatment of Cancer (EORTC) QLQ-G.I.NET21 questionnaire~        -  explore the correlation of toxicity outcomes and administered radiation doses corrected~          for body weight and body surface area~        -  explore the correlation of clinical efficacy outcomes with the levels of the biomarkers~          Chromogranin-A (CgA) in the serum and 5-Hydroxyindoleacetic acid (5-HIAA) in the urine~        -  evaluate dosimetry, pharmacokinetics (PK) and ECG in a subset of 20 patients~        -  explore the correlation of clinical efficacy outcomes with OctreoScan® tumour uptake~          score~        -  explore the correlation of clinical outcomes with serum levels of Alkaline Phosphatase~          (AP)~   "
151891|NCT01578226|"~     Infections are frequent life-threatening events in patients with cirrhosis, occurring at~     least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among~     cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no~     clear-cut clinical and biochemical features are helpful in diagnosing and prognostically~     stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker~     presenting high sensibility and specificity in diagnosing bacterial infections in different~     clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and~     prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.~   "
151892|NCT01578213|"~     The purpose of this study is to assess the capability of the dPCR technique to predict the~     absence of disease relapses after imatinib discontinuation in CML patients with negative~     Q-RT-PCR results for longer than 18 months.~   "
151893|NCT01578200|"~     The purpose of this study is to demonstrate decrease in cardiovascular mortality and~     morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with~     those with Calcium carbonate.~   "
151894|NCT01578187|"~     The purpose of this study is to test label comprehension and usability of the hair removal~     device in 60 male and female participants. The study population will represent the US~     demographic distribution of skin types and will include varying levels of literacy.~   "
151895|NCT01578174|"~     The investigators examined the effect of dexmedetomidine in the management of pain after~     uterine artery embolization.~   "
151896|NCT01578161|"~     After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many~     cases of agiation (over 80%) and despite of no report of long-term complication, agitation is~     a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for~     prevention of agiation of preschool aged children. The investigators expect single injection~     of dexmedetomidine lead to decrease postoperative agitation and pain without any complication~     like oculocardiac reflex requiring atopine for treatment.~   "
151897|NCT01578148|"~     The purpose of this study is to validate the efficacy of Noxipoint(TM) therapy on chronic~     pain, and compare it with standard physical therapy using electrical stimulation on patients~     with chronic pain.~      Invented by Dr. Charlie Koo at Stanford University, Noxipoint Therapy is a specific procedure~     with precise location, duration and intensity of TENS stimulation within the general FDA~     guidelines. The therapy substantially relieves general muscular/tendon pain and persistently~     restores the muscle and tendon function. The surface locations of nociceptors at the free~     nerve ending (i.e., Noxipoints) are focused on in the stimulation therapy. Multiple~     clinical uses of Noxipoint Therapy confirmed the consistent efficacy of such stimulation at~     Noxipoints. An observational study of Noxipoint therapy within the FDA-approved use of TENS~     demonstrated an encouraging 93% success rate in eliminating the chronic pain, such as frozen~     shoulder pain, within 2-3 sessions. It is an order-of-magnitude improvement over the~     non-specific application of TENS and any other modalities in pain treatment. A unique~     neuro-immuno-signaling pathway that implicates the activation of adult stem cells, such as~     satellite cells in muscles, is implicated based on such a high success rate.~   "
151898|NCT01578135|"~     This study is conducted in Europe. The aim of the study is to describe the patient population~     and therapeutic practices (study phase I), assess efficacy on growth and adult height and~     assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)~   "
151899|NCT01578122|"~     Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal~     deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its~     prevention. Therapeutic trials evidenced that elastic compression stockings (ECS) applying~     30-40mmHg of pressure at the ankle reduced the rate of PTS by 50%. Although ECS are unlikely~     to cause harm, in clinical practice, compliance to this treatment appears to be low as ECS~     may be difficult to apply and to wear.~      ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more~     comfortable. This could favor a better compliance.~      CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS~     applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of~     targeted pressure at the ankle~   "
151900|NCT01578109|"~     This pilot clinical trial studies the side effects of sorafenib tosylate before and after~     donor bone marrow transplantation in treating patients with acute myeloid leukemia. Sorafenib~     tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth.~   "
151901|NCT01578096|"~     The primary aims of this study are to:~        1. Tailor a diabetes stress management intervention for delivery by community health~          workers (CHWs) serving an urban Latino population.~        2. Investigate the efficacy of the stress management intervention on glycemic control.~           Secondary aims of this study are to:~        3. Investigate the efficacy of the stress management intervention on stress hormones,~          psychosocial functioning, and stress-glucose reactivity.~      Study hypothesis:~      A CHW-led group-based diabetes education model enhanced with stress management education will~     improve glycemic control more than CHW-led group-based diabetes education alone.~   "
151902|NCT01578083|"~     The investigators overall research hypothesis is that systemic chemotherapy induces~     structural changes in the white matter of the brain as demonstrated with Diffusion Tensor~     Imaging (DTI) and functional changes in well-defined cortical neural networks as demonstrated~     by resting-state functional connectivity MRI (rs-fcMRI). The investigators believe these~     structural and functional changes are responsible for the cognitive symptoms associated with~     chemotherapy-induced cognitive impairment (CICI).~      The Specific Aim for this study is:~      To assess the impact of chemotherapy on structural white matter as defined by DTI and~     functional cognitive networks as defined by rs-fcMRI by comparing a sample of breast cancer~     survivors with self-reported CICI to breast cancer survivors without CICI.~      Hypothesis: Post-chemotherapy breast cancer patients with self-reported CICI will have~     abnormal structural connections characterized by DTI-defined disruptions in fractional~     anisotropy (FA) and mean diffusivity (MD) and abnormal functional connectivity characterized~     by rs-fcMRI-defined disruptions in cognitive networks when compared to patients without~     self-reported CICI.~   "
151903|NCT01578070|"~     The purpose of this study is to show that ViscoGel® is safe when administrated alone and as~     an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the~     quantitative and qualitative effect on the immune response.~   "
151904|NCT01578057|"~     The purpose of this research study is to understand if there is any difference in the effects~     of tasimelteon when it is taken alone or in combination with alcohol. This research study is~     also being done to understand if there is any difference in the amount of tasimelteon (and~     its breakdown products) or alcohol in the blood when taken alone or together. Finally, the~     study will also look at the safety and tolerability (how acceptable it is) of tasimelteon.~   "
151905|NCT01578044|"~     Atrial fibrillation is common and increases the risk of clotting especially in patients with~     multiple clotting risk factors. Patients treated with warfarin, an oral anti-coagulant,~     require frequent lab monitoring and dose adjustments and are managed in pharmacy staffed~     anti-coagulation clinics that routinely contact them to remind them about blood draws,~     re-enforce medication adherence, and adjust dosing based on labs.~      Dabigatran, a newly approved medication that may be better for some with atrial fibrillation~     to lower risk of stroke and clotting, has been found to have fewer drug problems and~     eliminates lab monitoring need. Following instructions for taking dabigatran is important~     because it is a twice daily medication requiring monthly refills. Rivaroxaban is a once~     daily, newly approved Factor Xa inhibitor oral medication, prescribed to reduce risk of~     stroke and systemic embolism among patients with atrial fibrillation. Apixaban is a twice~     daily, FDA approved Factor Xa inhibitor oral anticoagulant, prescribed to reduce the risk of~     stroke and blood clots among patients with atrial fibrillation. In a double-blind RCT,~     apixaban was found to be superior to warfarin in reducing stroke, systemic embolism, and~     death. Patients on dabigatran, rivaroxaban, and apixaban will not be followed in~     anti-coagulation clinics, therefore will not benefit from the support provided by these~     clinics.~      It's anticipated many patients will be switched to dabigatran, rivaroxaban, or apixaban~     following recent publication of criteria for dabigatran use from the VA National Pharmacy~     Benefits Management Program, providing an opportune time to conduct the proposed adherence~     study. We will conduct qualitative interviews with patients(n~30) and pharmacists(n~20) to~     understand barriers/facilitators to oral anticoagulant adherence. Informed by the findings,~     we will develop and pilot test a multi faceted intervention to improve adherence among~     patients recently started on dabigatran/rivaroxaban/apixaban.~      Specific study aims:~        1. Conduct interviews with a sample of patients (n=30) recently started on dabigatran for~          atrial fibrillation to determine why patients do or don't take medications~        2. Conduct interviews with pharmacists (n=20) in anti-coagulation clinics in order to~          understand their opinions why patients do or don't take medications~        3. Informed by interviews, develop and test an intervention targeting patients/pharmacists~          to improve adherence to dabigatran/rivaroxaban/apixaban~   "
151906|NCT01578031|"~     The investigators' overall goal is to compare the effect of CPAP treatment on intermediate~     cardiovascular risk measures in obese versus lean patients with obstructive sleep apnea~     (OSA). The overall hypothesis is that, adjusting for OSA severity and obtaining normative~     data from non-OSA subjects with comparable amounts of visceral adiposity, the two OSA groups~     will have comparable improvements in daytime sleepiness, but that the cardiovascular and~     metabolic improvements following CPAP therapy will be decreased in OSA patients with~     increased visceral adipose tissue. The investigators anticipate that, although there will be~     a greater absolute change in markers of sympathetic activity, inflammation and oxidative~     stress in obese compared to lean OSA patients following CPAP treatment, the levels will still~     be abnormally high in the obese patients resulting in the decreased improvements in insulin~     resistance, arterial blood pressure, and vascular health in obese versus lean OSA patients.~   "
151907|NCT01578018|"~     DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem~     cells in colonic crypts. Mutations within the stem cell population are thought to be~     responsible for the development of most colorectal carcinomas and studies have shown that~     DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development~     of the foregut, the investigators speculate that DCAMLK1 will also be upregulated in lung~     cancers.~      The aim of this pilot study is to measure DCAMLK1 levels in the blood of patients with~     suspected malignant and benign lung diseases, and to correlate DCAMKL1 levels with smoking~     status.~   "
151908|NCT01578005|"~     Coronary angioplasty is rather frequently performed in such situations, presumably because,~     changes in the atherosclerotic plaque under drug treatment, have remained poorly described so~     far. Intravascular ultrasound (IVUS) enables a precise description of coronary atheroma,~     better than the one provided by coronary angiography.~   "
151909|NCT01577992|"~     Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder. MSA is dominated by~     autonomic/urogenital failure which may be associated with either Parkinsonism (MSA-P subtype)~     or with cerebellar ataxia (MSA-C subtype). The prognostic of this disease is bad because it~     ended with the patient's death few years later. No neuroprotective treatment has shown a real~     efficacy. 50% of patients suffering of MSA frequently experienced painful sensation. The~     origin of this pain is unknown. In Parkinson disease (PD) ; arguments suggest the implication~     of dopamine neuromediator pathway in integration and modulation of pain. Several studies~     suggest the existence of various influences with dopamine implication in the appearance of~     painful sensation and that would be inhibitory. That's why observed painful symptoms in MSA~     and PD could be due to a decrease of pain appearance threshold, secondary to a lost of~     control of sensitizes centres, to Parkinson control.~      It is interesting to determine if MSA as PD is responsible for a decrease of pain threshold~     and to characterise the levodopa effect on the patient's pain threshold. Better~     physiopathology knowledge of pain in MSA is necessary to improve the therapeutic care.~     Because the efficacy of others treatments is low, it's important to improve the research for~     a better comfort of patients with a better understanding, analysing and treating of the pain.~   "
151924|NCT01577797|"~     This Phase I, randomized, 22-day crossover study seeks to improve treatment outcomes for~     methamphetamine-dependent subjects by developing a cognitive behavioral therapy (CBT)- based~     short message service (SMS) text messaging intervention as an adjunct to CBT group therapy.~   "
160323|NCT01467557|"~     This study is an observational registry of patients who have recently been prescribed 1•DAY~     ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.~   "
151912|NCT01577953|"~     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway~     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent~     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of~     the immune system caused by cytokine production. A substantial number of asthma patients do~     not satisfactorily respond to steroid therapy and consequently have an unmet medical need for~     novel targeted therapies with improved specificity, tolerability, and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of asthma. The~     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and~     has been shown to be necessary and sufficient for the production of cytokines interleukin~     (IL)-4, IL-5, and IL-13. The active drug substance of the investigational medicinal product~     SB010 is hgd40. SB010 belongs to a new class of antisense oligonucleotide therapeutics, the~     10-23 DNA (deoxyribonucleic acid)zymes (antisense oligonucleotide).~      DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic~     acid) molecules. By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production and~     thereby reduces key features of allergic airway inflammation. DNAzymes are generated~     completely by chemical synthesis and can be produced under Good Manufacturing Practice (GMP)~     controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by~     use of any living organism including cell culture or bacteria. The molecules are highly~     water-soluble and will be applied as solution directly in their synthesized form.~      The current study will evaluate the safety and tolerability of increasing single doses of~     inhaled SB010 in male patients with asthma who have airway hyperresponsiveness(demonstrated~     by methacholine bronchial challenge test).~   "
151913|NCT01577940|"~     The purpose of this method study in healthy volunteers is to determine the extent of sensory~     block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine~     versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block~     and the influence on the lung function.~   "
151914|NCT01577927|"~     Patients at high complexity with severe chronic diseases can require several admission in~     intensive care units (ICU) to overcome acute exacerbations by the use of assisted~     ventilation. In the last 10 years, new technologies and beds in ICU evidenced a new group of~     patients often needing weaning procedures due to a long-lasting period of mechanical~     ventilation. These patients are often under chronic conditions with recurrent symptoms,~     reduced effort tolerance and depression.~      Weaning process is a frail step in the medical history of a patient who has survived an acute~     episode of respiratory failure and has spent a period of time under mechanical ventilation.~     Patients are followed for the duration of in-hospital stay, an expected average period of 4~     weeks.~      When discharged fron an Intensive Care Unit (ICU) or a weaning center, the patient is usually~     managed by GPs and by the hospital where he has been admitted to following re-exacerbations.~     The conventional approach is for sure inadequate for this type of patient whose clinical~     complexity, disability and frailty need for a continuity of care through a higher complex~     approach of management.~      A structured program of Home Rehabilitation could be a possible solution to this problem.~     Thus, the hypothesis of the study is to evaluate feasibility and sustainability and efficacy~     of a home rehabilitative network for prolonged weaned patients discharged from a weaning~     unit.~   "
151915|NCT01577914|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult, human subjects.~   "
151916|NCT01577901|"~     Female volunteers, requiring to conduct a personal pregnancy test will use Clearblue Advanced~     Pregnancy test, following the instructions for use. The test will be conducted following both~     the instructions for the in stream method of sampling and the method of testing when a sample~     is collected into a container. The results will be compared to those achieved by the study~     technician.~   "
151917|NCT01577888|"~     To study the early safety and performance of the Shockwave Medical System in subjects to~     demonstrate that the device can safely and effectively deliver localized energy for the~     treatment of vascular disease.~   "
151918|NCT01577875|"~     The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow~     band imaging.~   "
151919|NCT01577862|"~     Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with~     high lethality in hospitalised critically ill patients. It can acquire resistance to all~     classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may~     be the only therapeutic option. However, colistin is not registered for this indication. The~     addition of rifampicin to colistin has been shown to be synergistic in vitro, and may be~     promising in vivo, but this combination has not been studied in comparison with colistin~     alone.~      The purpose of this randomised, open-label, multicentre clinical trial is to assess whether~     the association of colistin and rifampicin reduces significantly the mortality of patients~     with severe MDR A. baumannii infections compared with colistin alone.~      The trial will enroll 210 patients from intensive care units (ICU) of five tertiary care~     hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be~     randomly allocated to either colistin alone (control arm) or colistin plus rifampicin~     (experimental arm).~      Primary end point is overall mortality, defined as death occurring within 30 days from~     randomisation.~      Secondary end points will be disease-specific death, microbiological eradication,~     hospitalization length, emergence of resistance to colistin during treatment.~   "
151920|NCT01577849|"~     The purpose of this study is to compare the pharmacokinetic characteristics of DP-R206 (150mg~     Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Vitamin D3 (24,000 IU Vitamin D3 ,~     qd) after oral administration in healthy adult volunteers.~   "
151921|NCT01577836|"~     The main objective of the study is to estimate and compare the overall cost of care of~     patients over 24 months of follow-up between two groups: (1) patients undergoing~     robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing~     robot-assisted radical prostatectomy via laparotomy.~   "
151922|NCT01577823|"~     A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical~     patients receiving spinal anesthesia. Study will track clinical outcomes, patient~     satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary~     tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden~     without increasing postoperative urinary retention (POUR) incidence.~   "
151923|NCT01577810|"~     It is routine practice for a cardiologist to perform a battery of tests to assess the degree~     of heart failure. The purpose of this study is to establish a non-invasive method to reliably~     predict cardiac output state in real-time in children and adolescents with heart failure in~     an outpatient setting. This study will rely on the use of near infrared spectroscopy monitors~     to measure cardiac output in the outpatient setting.~   "
151925|NCT01577784|"~     The principal aim of the study is to determine the objective response rate that offers the~     second-line treatment with pazopanib in patients with carcinoma of advanced renal cells that~     have progressed or that have not tolerated the first line of treatment with a Tyrosine Kinase~     Inhibitor. The secondary aims are to determine the overall survival and the treatment safety~     profile for these patients in second-line treatment with pazopanib. The exploratory aim is to~     determine the correlation between biomarkers in patient blood and tumor samples, and the~     clinical results obtained with pazopanib.~   "
151926|NCT01577771|"~     This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal~     conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso.~     Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and~     9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be~     assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age~     will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart.~     Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later.~     Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA~     assessments pre-vaccination and 1 month post-vaccination.~      The immunogenicity and reactogenicity of PCV13 in the standard schedule groups (e.g. 6, 10,~     14 weeks for infants and single dose for toddlers) will be compared to that observed in the~     PCV13 licensure trials. Within each age group the alternative schedule will be compared to~     the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage~     (infants only).~   "
151927|NCT01577758|"~     This is an Open-Label, Multicenter, Dose Escalation, First-in-Human Study of MLN0264 in Adult~     Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C.~   "
151928|NCT01577745|"~     This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation~     (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity~     of MEDI0639.~   "
151929|NCT01577732|"~     This study aims to evaluate the safety and reactogenicity of a booster dose of~     Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age~     who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within~     their first six months of lives.~   "
151930|NCT01577719|"~     People who originate from the Indian subcontinent known as South Asians are the fastest~     growing group of non-white Canadians. They suffer an excess prevalence of abdominal obesity,~     type 2 diabetes and heart disease. They also develop these risk factors at significantly~     lower body weight and at younger ages compared to people of European origin. The purpose of~     SAHARA (South Asian HeArt Risk Assessment) Pilot, is to recruit 400 South Asians from~     Ontario, who use the internet, email and other multimedia devices. Among these participants~     the investigators will compare the effectiveness of a 6-month interactive multi-media health~     behaviour intervention to usual care in reducing cardiac risk factors. This intervention~     enables participants to set their health goals and provides health messaging and feedback~     designed to improve their smoking, dietary habits and physical activity. In addition, the~     investigators will test if knowledge of genetic risk for heart attack influences behaviour~     change and their heart health risk factor profile. The information generated from SAHARA will~     enable individuals, physicians, health professionals, and policy makers to develop risk~     factor modification programs to prevent cardiovascular disease in this high-risk group.~   "
151931|NCT01577706|"~     An advanced technique for rapid magnetic resonance proton spectroscopic imaging (1H-MRSI)~     will be employed in a drug challenge study in healthy volunteers to spatially map and measure~     acute changes in the brain chemicals GABA, glutamate and glutamine after administration of a~     drug. Three condition will be tested in a double-blind fashion, i)depressant, ii)stimulant,~     iii)placebo. It is hypothesized that unique and reproducible spatial and directional~     metabolic response patterns will be observed, unique to each condition within the brain.~   "
151932|NCT01577693|"~     The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel~     formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted~     healthy male subjects.~   "
151933|NCT01577680|"~     This study will assess the safety and pharmacokinetics of GSK573719 and GSK573719/vilanterol~     combination in healthy subjects and subjects with moderate hepatic impairment. The results of~     this study will provide guidance on the use of the product in patients with hepatic~     impairment.~   "
151934|NCT01577667|"~     Partial automation of mechanical ventilation in resuscitation has been available for several~     years. New modalities are being developed to completely automate ventilation and oxygenation~     parameters (IntelliVent®.~      This pilot study compares over a 48h period the safety and efficacy of IntelliVent®, versus a~     conventional ventilation modality.~   "
151935|NCT01577654|"~     This study will test the activity of single-agent EC145 and the combination of EC145 plus~     docetaxel against the current standard docetaxel in second line Non Small Cell Lung Cancer~     (NSCLC) (adenocarcinoma, squamous, adenosquamous or adenocarcinoma with other NSCLC variants~     of the lung) in participants with all target lesions expressing the folate receptor [FR(++)].~   "
151936|NCT01577628|"~     There is a lack of prospective scientific data on the regular use of moisturizers in patients~     at risk of developing atopic dermatitis. Although generally accepted and widely used for~     secondary prevention, emollients have not been studied as a primary prevention strategy.~     Strategies previously studied for the prevention of atopic dermatitis include maternal and~     child's dietary manipulations, allergens avoidance, delay of food introduction, exclusive~     breastfeeding and probiotic supplementation. Despite years of research, none of those~     strategies yielded to strong evidence of a protective effect. There is therefore a need to~     explore novel strategies.~      There is a need to compare the cumulative incidence rate of atopic dermatitis in newborns~     using a standard bathing and moisturizing routine with a good moisturizer to a non~     interventional group.~      This 2-year study will recruit approximately four hundred and sixty (460) pregnant women with~     a first degree relative of the child to be born who currently has (or previously had) a~     diagnosis of atopic dermatitis in order to study approximately 200 eligible newborns in each~     of the two study groups at the beginning of the study.~      Pregnant women will be randomized (1:1) to either daily use of the moisturizer Lipikar Balm~     AP (applied to their infant) starting from birth (Group 1) immediately after bathing or to no~     intervention (Group 2).~   "
151937|NCT01577615|"~     The PEPI study is designed to provide a patterned feeding experience. By using a regularly~     occurring and necessary caregiving event, feeding, as the vehicle for the patterned~     experience, the intervention should be effective at promoting and reinforcing neuronal growth~     and connections that are critical for neurobehavioral and cognitive function while at the~     same time being cost effective in its delivery.~   "
151938|NCT01577602|"~     The purpose of this study is to determine if two basic medical office visit interventions~     improve the agreement of medication lists between electronic medical record and patient self,~     home-based report. The interventions are:~        -  giving patients a printed list of medications before the visit~        -  asking the patients about their medications with a scripted, open ended question.~   "
151939|NCT01577589|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     Ceftaroline 600 mg when administered by varying infusion volumes.~   "
151940|NCT01577576|"~     The main objective of this study is to obtain data for the integrated analysis of~     morphological, functional and biomechanical parameters pertaining to lower limb arteries in~     various categories of elite athletes (without cardiovascular risk and practicing high- or~     low-impact aerobic activities which preferentially implicate lower limb activity) as compared~     to (each other and to) sedentary controls.~   "
151941|NCT01577563|"~     RATIONAL is a multinational, multicentre, observational, cross sectional study of adult~     patients in treatment with NSAID therapy for OA, RA or AS during for at least 2 weeks before~     study visit (at least one dose).~   "
151942|NCT01577550|"~     Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to~     severe psoriasis.~   "
151943|NCT01577537|"~     The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to~     placebo gel for the treatment of bacterial vaginosis (BV).~      After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or~     hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime~     for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and~     Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12)~     and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day~     21-30).~   "
151944|NCT01577524|"~     The purpose of the study is to determine whether diluted Povidone Iodine solution used to~     irrigate surgical wounds during spine surgery decreases the incidence of surgical site~     infections.~   "
151945|NCT01577511|"~     The main objective of this study is to identify and characterize subpopulations of cells with~     invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples.~   "
151946|NCT01577498|"~     Economic globalisation has been associated with a rise of cross-border migration in Europe.~     In France, courts commonly demand appropriate medical tests aimed at age estimations of~     supposed minors without documentation. Determining the age of foreign adolescents may be~     important in order to define the rights and protection afforded them by law depending on this~     status, and the conditions in which they may be detained or held in police custody if they~     are under suspicion. Age estimation is considered to be ideally based on the combination of~     clinical, skeletal, and dental examinations. A number of forensic physicians do not integrate~     published recommendations or the results of published studies into their daily practice.~     Previous studies have shown that medical practice is heterogeneous in this area. Factors~     determining this heterogeneity are unknown.~      We hypothesize that the personal and professional development of the physician, as well as~     the characteristics and the circumstances of medical examination can affect medical response~     on age determination, beyond clinical and radiological data. The purpose of this study is to~     identify factors determining medical response to courts.~   "
151947|NCT01577485|"~     We want to study the effect of short-term consumption of probiotics (a mixture of L.~     rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.~   "
151948|NCT01577472|"~     The aim of this study is to assess the oocyte yield of infertile women with suspected or~     known poor ovarian reserve (POR) undergoing a GnRH antagonist protocol for IVF with Merional®~     starting either with a low (150 IU) or a high dose (450 IU) and adding 100mg of CC~     (Serophene®) in the early follicular phase of the stimulation (day 3 to 7). To date no RCT~     has been conducted to compare the reproductive outcome of patients with POR as defined by the~     ESHRE Bologna criteria after controlled ovarian hyperstimulation with HMG in an GnRH~     antagonist protocol using low doses versus high doses of HMG and adding CC versus placebo. We~     hypothesize that adding 100 mg of CC on day 3-7 to a HMG antagonist protocol will lead to an~     additional increment of endogenous GT thus increasing the oocytes yield after controlled~     ovarian stimulation due to higher endogenous gonadotropin secretion.~   "
151949|NCT01577459|"~     This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the~     pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult~     volunteers.~   "
151950|NCT01577446|"~     Current recommendations require a QRS duration of ≥120ms as a condition for prescribing~     cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that~     patients with heart failure of ischemic origin, current indications for defibrillator~     implantation and QRS <120ms may benefit from CRT in the presence of marked mechanical~     dyssynchrony.~   "
151951|NCT01577433|"~     The purpose of this observational registry is to determine the freedom from driveline (DL)~     infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone~     portion of the DL is externalized resulting in a silicone skin interface (SSI)~   "
151952|NCT01577420|"~     The aim of this study is to test a complementary therapy intervention (reflexology) that will~     assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage~     (III or IV) breast cancer within the context of conventional medical care. Quality of life~     will be assessed via intermediate indicators: 1) physical indicators (greater physical~     functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower~     anxiety, and lower depressive symptomology); and the outcome indicator of quality of life.~   "
151953|NCT01577407|"~     The purpose of this protocol is to test the effects of the non opioid nefopam on experimental~     dyspnea and on the counterirritation (ie inhibition of one pain by another pain) induced by~     dyspnea in healthy subjects.~   "
179435|NCT01216293|"~     The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR),~     once daily (QD), on bone homeostasis.~   "
151956|NCT01577368|"~     The main objective is to verify that the administration of piperacillin / tazobactam~     administered by continuous infusion to treat complicated infections or with known or~     suspected nosocomial isolation of Pseudomonas aeruginosa is superior in efficacy to a 30%~     higher dose administered in conventional short infusion.~      The secondary objectives were compared between the following variables:~        -  Microbiological response at 3 days of starting treatment~        -  Time to microbiological cure~        -  Clinical response at 3 days of starting treatment~        -  Time to achieve defervescence~        -  To examine the relationship between pharmacokinetic variables and parameters of efficacy~          and safety~        -  To test the hypothesis that continuous infusion maintains adequate plasma drug levels~          compared with levels achieved with intermittent administration.~        -  Cost-effectiveness analysis~        -  Occurrence of adverse effects~      To this end, we designed a multicenter, randomized, controlled, double blind, comparing both~     forms of administration in patients with complicated or nosocomial infection with or without~     isolation of Pseudomonas aeruginosa.~      Patients who are candidates for inclusion are classified according to APACHE II and to have~     or not isolation of Pseudomonas aeruginosa. Subsequently be randomized to receive~     piperacillin-tazobactam by continuous infusion or short. Primary endpoint was measured as the~     ultimate effectiveness of treatment and other variables such as high efficiency, safety,~     pharmacokinetic and pharmacoeconomic.~   "
151957|NCT01577355|"~     This is a single dose study of radiolabelled LY2784544 in healthy male subjects to study the~     absorption, distribution, metabolism and excretion of LY2784544. This study is for research~     purposes only and is not intended to treat any medical condition.~   "
151958|NCT01577342|"~     Ranibizumab (Lucentis) is currently the best treatment for wet Age-Related Macular~     Degeneration (AMD). To work, the drug must be injected by means of an intravitreal injection~     (IVT) into the vitreous (jelly-like material) cavity in the back of the eye, repeatedly at~     intervals ranging from one to several months. Endophthalmitis is a rare but devastating~     infection of the eye that occurs in approximately 0.2% of patients after IVT injection. Many~     ophthalmologists ask patients to use antibiotic eye drops after IVT injection in the hope~     that this may reduce the risk of endophthalmitis. There is no proof that this happens and~     there is a possible risk that repeated exposure to the same antibiotic may cause antibiotic~     resistance organisms (bacteria) to develop over time.~      The investigators hypothesize that repeated exposure to antibiotic during the initial stages~     of treatment for AMD will result in a progressive shift in the conjunctival flora with an~     increasing number of antibiotic resistant organisms appearing over time. If this is~     demonstrated, changes to the prevailing treatment approach will be needed to reduce the long~     term risk of a patient developing antibiotic resistant endophthalmitis during treatment.~   "
151959|NCT01577329|"~     The purpose of this study is to assess the feasibility and potential impact of an eight week~     program of meditation on expiratory time, anxiety and dyspnea in people with COPD.~   "
151960|NCT01577316|"~     The hypothesis proposed in this study is that the 2011-2012 Seasonal Influenza Vaccine~     (including H3N2 and H1N1 subtypes of serotype A strain over the serotype B) administered to~     15ug (without adjuvant) via intramuscular in pregnant women will be safe and immunogenic.~   "
151961|NCT01577303|"~     The purpose of this study is to determine whether different internet-based treatment~     programs, consisting of cognitive bias modification, reduce symptoms of social phobia among a~     population diagnosed with this disorder.~   "
151962|NCT01577290|"~     The purpose of this study is to examine the effects of a 10 week mindfulness training program~     -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of~     life, and insomnia symptoms will also be studied.~   "
151963|NCT01577277|"~     The present study is based on cross-sectional data from the baseline investigations carried~     out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary schools~     in Denmark 2011-2012. Approximately 800 Danish school children from 3rd and 4th grades (8-12~     year olds) took part in these baseline investigations of socioeconomic status, pubertal~     status, growth status, learning abilities, well-being, sleep, physical activity and risk~     markers of Cardiovascular Disease (CVD), type II diabetes and osteoporosis.~   "
151964|NCT01577264|"~     This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated~     with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.~   "
151965|NCT01577251|"~     The goal of this study is two-fold: to establish a tissue banking respository (defined as~     blood, urine, soft tissue, tumor specimen, and normal tissue from areas surrounding tumor~     specimens), and to prospectively assess health related quality of life (QOL) over time in~     patients with a pathologically confirmed diagnosis of neoplasia receiving radiotherapy or~     photodynamic therapy (PDT)~   "
151966|NCT01577238|"~     The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to~     placebo gel for the treatment of bacterial vaginosis (BV).~      After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or~     hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime~     for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and~     Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12)~     and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day~     21-30).~   "
151967|NCT01577225|"~     OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer,~     lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is~     coated with a water-based adhesive. The comparator is a standard care treatment regime~     comprising tape and gauze.~      This study requires 100 eligible patients which will be recruited from the patients routinely~     see by the study investigators at each study site. Eligible patients will undergo surgery~     that results in a surgical wound of 27cm or less that is expected to have low or moderate~     levels of exudate and will have received at least one randomised study treatment. The primary~     objective is to compare OPOV and tape/gauze in terms of wear time per patient.~   "
151968|NCT01577212|"~     The aim of this present study is to test the feasibility and toxicity of individualized~     hypofractionated radiotherapy, and to report outcome data. In case this phase II trial has~     favorable results, a phase II/III trial on maximally tolerable, individualized,~     hypofractionated radiotherapy within a shorter overall-treatment time is aimed for.~   "
151969|NCT01577199|"~     The purpose of this study is compare two commonly-used medication protocols ( low-dose~     clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with~     diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF.~     This research is being done because we do not know if these two medication protocols are~     equally likely to help a woman become pregnant.~   "
151970|NCT01577186|"~     The purpose of this study is to explore the relationship between achieving symptomatic~     remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and~     personal and social functioning by means of the Personal and Social Performance (PSP) scale~     in participants treated with flexibly dosed paliperidone ER.~   "
151971|NCT01577173|"~     This phase II, open-label, randomized study will evaluate the efficacy and safety of~     MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of~     the head and neck who have progressed during or following platinum-based chemotherapy.~     Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2~     weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients~     treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation~     of progressive disease and upon meeting eligibility criteria. Anticipated time on study~     treatment is until disease progression or intolerable toxicity occurs.~   "
151972|NCT01577160|"~     The purpose of this study is to evaluate the effectiveness of paliperidone ER for the~     treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability,~     detachment from reality, often with delusions and hallucinations, and withdrawal into the~     self) participants.~   "
151973|NCT01577147|"~     Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation~     prediction products to help identify their most fertile time and aid conception. Volunteers~     will provide SPD with a daily urine sample throughout the study period, which will be used~     for the development and validation of SPD products related to pregnancy and fertility.~   "
151974|NCT01577134|"~     PREFER II aims at developing psychological targeted theory- and evidence-based intervention~     components, which support older people with multiple illnesses in performing more physical~     activity. Many studies provide evidence for the importance of physical activity as a central~     mediator of health. This means that determinants of physical activity such as personal~     resources constitute an ideal target for interventions.~      Within PREFER II, particularly positive views on ageing, attitudes, self-efficacy, planning~     and self-monitoring will be targeted in the interventions. These factors are important both~     for motivating older people with multiple illnesses to change their health behaviors and to~     translate such motivation into behavior.~   "
151975|NCT01577121|"~     To demonstrate if indomethacin associated to conventional treatment for preterm labor is~     useful to delay delivery and to improve neonatal morbimortality in women with preterm labor~     with high risk of intraamniotic inflammation~   "
151976|NCT01577108|"~     The purpose of this study is to examine whether daily use of oral gelatin capsules containing~     dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can reduce the GBS~     colonization rate of vagina and rectum in pregnant women who present with GBS-positive~     diagnosed by GBS culture at 35-37 weeks gestation.~      This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS~     screening culture are carried out for all pregnant women at 35-37 weeks of gestation in our~     out-patient department. Subjects with vagina and rectum GBS colonization are invited to~     participate in our study after informed consent. A total of 200 pregnant women will~     participate in the study during the 12-months trial period. They are randomly assigned to one~     of the two groups. The study group is treated with two oral capsules of probiotics once daily~     (before sleeping) for 14 days, and the control group will take 2 capsules of placebos.~     Vaginal and rectal GBS culture is repeated for all participators 2 weeks later. All~     participators will treated according to GBS guideline by CDC in 2002 during laboring.~   "
151977|NCT01577095|"~     Aims: To evaluate the efficacy of rosiglitazone (TZD) and electroacupuncture (EA) combined~     therapy on patients with type 2 diabetes mellitus (T2DM). A randomized single-blind placebo~     controlled clinical trial was used.~      Methods: A total of 31 newly diagnostic type 2 diabetic patients, who fulfilled the~     eligibility criteria were recruited and received various allocated interventions. They were~     randomly assigned into two groups, the control group (TZD, N=15) and the experimental group~     (TZD + EA, N=16). Changes in their plasma free fatty acid (FFA), glucose and insulin levels~     together with their homeostasis model assessment (HOMA) indices were statistically assessed~     between before and after treatment. Hypoglycemic activity (%) was also compared between these~     two groups.~      Expecting Results: This study will compare the hypoglycemic activity and the ability of~     improving insulin resistance between the TZD and TZD+EA group. Also, the lowering effect of~     the plasma FFA concentration will be investigated.~   "
151978|NCT01577082|"~     The purpose of this study is to show the superiority of CHF 1535 (BDP/FF) pMDI over BDP HFA~     pMDI in terms of lung function considering change from baseline to the entire treatment~     period in average pre-dose morning PEF in adult asthmatic patients not adequately controlled~     on high doses of ICS or on medium dose of ICS+LABA.~   "
151979|NCT01577069|"~     The purpose of the study is to~      1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS)~     technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients~     under/after Telaprevir treatment.~   "
151980|NCT01577056|"~     The purpose of this study is to determine whether fish oil supplementation is effective in~     the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.~   "
151981|NCT01577043|"~     The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea~     in children. The investigators will evaluate the effect of product versus placebo.~   "
152018|NCT01576562|"~     The purpose of this research study is to test the function of a subjects implantable~     cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD~     function can be altered during some types of heart surgery such as those when a pump~     (ventricular assist device - VAD) is implanted. The investigators would like to study the~     mechanism of device and ICD malfunction.~   "
152366|NCT01571999|"~     This study will assess the safety and pharmacokinetics of inhaled GSK573719 and~     GSK573719/vilanterol combination in healthy subjects and in subjects with severe renal~     impairment. The results of the study will provide guidance on the use of this product in~     subjects with severe renal impairment.~   "
151982|NCT01577030|"~     Elevated systolic blood pressure is by far the largest single contributor to cardiovascular~     risks in middle-aged and older adults. Lifestyle modifications, including dietary~     modifications, are the first line approach for treating and preventing hypertension. The~     general aim of the proposed study is to address the efficacy of conventional dairy products~     as part of the normal routine diet for lowing arterial blood pressure in middle-aged and~     older adults with elevated blood pressure. The investigators hypothesize that the dietary~     intervention including dairy products will induce significant decreases in arterial blood~     pressure in this population. A secondary aim will be to test the hypothesis that these~     reductions in systolic blood pressure will be associated with increases in arterial~     stiffness/compliance and endothelial vasodilatory function.~   "
151983|NCT01577017|"~     As both medications i.e. CC and letrozole have been shown to be effective in inducing~     ovulation in PCOS patients, this study was performed in order to evaluate which regime~     (whether CC or letrozole) is the best to be used as the first line treatment for PCOS~     patients with infertility for local population. The best regime will therefore could be~     included in the protocol of management of infertility patients with PCOS so that the quality~     of patients' care could be improved.~   "
151984|NCT01577004|"~     BACKGROUND: Compared to the epsilon 2 or epsilon 3 alleles, the epsilon 4 allele of~     apolipoprotein E (ApoE4) is associated with twice the prevalence of late-onset Alzheimer's~     disease (AD). Epidemiological studies show that risk of AD varies inversely with consumption~     of omega-3 fatty acids from fish and seafood. Despite apparently lower fish intake in AD,~     pooled analysis of the literature shows that plasma and brain docosahexaenoic acid (DHA) is~     actually the same in AD as in healthy age-matched controls. Fish oil trials in AD are also~     not convincing. We recently shown that ApoE4 carriers have 41% higher fasting plasma EPA and~     DHA compared to non-carriers, but the plasma EPA and DHA response to fish oil in ApoE4~     carriers was half that seen in non-carriers.~      HYPOTHESES: (i) Carriers of ApoE4 have altered metabolism of carbon-13 (13C)-DHA as well as~     EPA and DHA provided in a dietary supplement. (ii) A dietary supplement of EPA+DHA will~     improve cognitive performance but only in non-carriers of ApoE4.~      OBJECTIVES: In both carriers and non-carriers of ApoE4, to compare whether- i) ApoE4 alters~     incorporation of 13C-DHA into plasma lipids or its beta-oxidation.~      ii) 13C-DHA metabolism changes while on a dietary supplement of EPA+DHA; iii) Better~     cognitive performance occurs while on EPA+DHA and is linked to raising plasma EPA and/or DHA.~      EXPERIMENTAL METHODS: Participants older than 50 y old and not demented were enrolled. DHA~     metabolism was evaluated using both 13C-DHA and an EPA+DHA supplement (2.4 g/d for 5 mo; n =~     20/gp). Before and in the last month of supplementation, plasma uptake and beta-oxidation of~     50 mg of 13C-DHA was followed during one month. Blood omega-3 fatty acids was evaluated~     monthly during the supplementation period. Cognitive testing was performed before and 4~     months after starting the omega-3 fatty acid supplement.~      IMPLICATIONS: This project will help explain the apparent link that is newly emerging between~     ApoE polymorphisms, altered omega-3 fatty acid metabolism and risk of cognitive decline, and~     should help in the development of nutraceutical-based clinical trials using fish oil for the~     elderly.~   "
151985|NCT01576991|"~     The purpose of the study is to describe the relationship between leukocyte, granulose cell~     and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of~     oocyte spindles and their frequency in the eggs from older women and associations with~     aneuploidy.~   "
151986|NCT01576978|"~     The aim of this study is to identify evaluate the effectiveness of stretching exercises of~     Hatha Yoga method in pregnant women with back pain and posterior pelvic City Paulínia. -There~     will be a randomized clinical trial with 60 pregnant women with these symptoms. They will be~     randomly divided into 2 groups. The group A will perform the exercises of Hatha Yoga for ten~     weeks, once a week group B postural follow the guidelines recommended for the treatment of~     these pains, for ten weeks. Will be used as a technique for evaluating the Visual Analogue~     Scale to measure pain intensity and confirmation tests of the lumbar and posterior pelvic~     pain in order to differentiate them. A descriptive statistical analysis of univariate and~     bivariate distributions will be made through frequency and graphical representation. The~     association between the variables will be tested by statistical tests: [chi-square (X ²)],~     Fisher's exact test, Student's t test or Mann-Whitney, [Student's t test to compare means],~     ANOVA for the analysis of effects between the groups. [The significance level is~     predetermined to 5%]. The data will be analyzed in EPI-INFO 2000. SAS 9.0 and from the~     database created .~   "
151987|NCT01576965|"~     The purpose of this study is to learn about bowel preparation (cleansing) before laparoscopic~     hysterectomy and/or sacrocolpopexy. We are most interested in the ability of the surgeon to~     view necessary anatomy for the surgery, which will be assessed by a questionnaire completed~     at the end of your operation by the surgeon. We hypothesize that bowel preparation before~     laparoscopic hysterectomy will result in improved ability of the surgeon to view necessary~     anatomy for the surgery.~   "
151988|NCT01576952|"~     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of~     topical administration of ISV-303 compared with DuraSite Vehicle.~   "
151989|NCT01576939|"~     The main objective of this study is to determine the feasibility of optimizing the IMRT~     treatment plan based on dosimeter measurements of mucosal radiation dose adjacent to the~     dental fillings to reduce such dose to < 35 Gy without compromising tumor coverage and/or~     increasing the dose to the remaining oral cavity or nearby parotid glands.~   "
151990|NCT01576926|"~     Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation~     stylopharyngeal muscle.~   "
151991|NCT01576913|"~     Study hypothesis: Music pacing improves the quality of exercise testing in children.~      Children tend to cycle in a non-constant pace during exercise testing, which might make the~     test less reliable.~      20 boys will perform two exercise tests on a cycle ergometer. One test will be done with~     constant tempoed music, and the other without. Different parameters will be checked including~     pedaling cadence, aerobic fitness, level of work load obtained.~   "
151992|NCT01576900|"~     In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better~     outcomes.~      Systemic video instruction might prove to be beneficial by helping patients have better~     understanding on treatment and replacing healthcare personnel.~   "
151993|NCT01576887|"~     This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl~     treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM)~     on peritoneal dialysis.~   "
152019|NCT01576549|"~     This study will investigate how LY2127399 works in participants with rheumatoid arthritis~     (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399~     via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study~     procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA~     activity.~   "
152020|NCT01576536|"~     The aim of the study is to test whether genetic variation in the alpha 2A adrenergic receptor~     affects diurnal variation in platelet aggregation.~   "
151994|NCT01576874|"~     The purpose of this study is to determine the impact of gender and hormones (estradiol,~     progesterone, testosterone and cortisol) on responses to stress and smoking cues presented in~     daily, real-world cue presentations compared to a final cue session in a lab. In addition,~     the study will examine the impact of a single dose of oxytocin (chemical produced in the~     body) versus placebo (inactive substance) on stress in males and females.~      This study involves a cue presentation technology known as CREMA (Cue Reactivity Ecologic~     Momentary Assessment) which delivers four daily cue presentations to you on a handheld device~     during your everyday routine. Additionally, the study involves daily collection of saliva~     samples for hormonal testing. These daily procedures will provide information about the role~     of cues and hormones in daily life.~   "
151995|NCT01576861|"~     After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients~     With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the~     investigators wanted to collect data about the long-term efficacy and safety of this kind of~     therapy.~   "
151996|NCT01576848|"~     Rationale: Age related muscle loss (sarcopenia) is assumed to be related to the impaired~     postprandial muscle protein synthetic response to protein and/or amino acid administration in~     the elderly vs the young. Co-ingestion of carbohydrate increases post-prandial insulin~     secretion. Insulin affects skeletal muscle blood flow and may therefore affect substrate~     availability and postprandial muscle protein synthesis. However, it is unclear whether the~     response to the combined intake of protein and carbohydrates is different in elderly compared~     to young subjects.~      Hypothesis: Adding carbohydrate to a bolus of protein represents an effective strategy to~     overcome the impaired postprandial muscle protein synthesis in the elderly.~      Objective: The primary objective of the study is to investigate whether carbohydrate~     co-ingestion augments the in vivo postprandial muscle protein synthetic response after~     protein ingestion and whether this response is different between young and elderly subjects.~     The secondary objective of the study is to assess the effect of carbohydrate co-ingestion on~     insulin levels and microvascular perfusion in young and elderly subjects.~      Intervention: The intervention consists of a single test day during which the subjects will~     receive a drink containing 20 gram intrinsically labelled casein with or without 60 gram~     carbohydrates. In addition, continuous intravenous tracer infusions of labeled amino acids~     will be administered. During the test day 18 plasma samples and 4 muscle biopsies will be~     collected over a period of 8½ h. Furthermore, muscle skeletal blood flow will be estimated~     using sidestream darkfield imaging (SDF) in sublingual position.~   "
151997|NCT01576835|"~     This study will compare the results of a clinically ordered abdominal CT angiography to a~     research non-contrast MR angiogram (MRA). CTA is a gold-standard for identifying blockages~     in the kidney arteries or other blood vessel problems. CTA requires radiation and contrast to~     obtain useful images. Conversely, the MR abdomen technique being used for the study uses no~     radiation or contrast and is felt to be a safer option for individuals who have kidney~     problems. there is benefit to establishing non-contrast MRA as a clinically accurate test.~   "
151998|NCT01576822|"~     The goal of this study is to assess the feasibility of the approach, conduct a dose-finding~     investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials~     in the assessment of human chemical body burden reduction, for general wellness,~     detoxification, and pain reduction.~      The investigators wish to determine if a hyperthermia-based detoxification protocol is~     feasible to conduct: including assessment of recruitment, enrollment, retention, protocol~     adherence, adverse events, and changes in serum polychlorinated biphenyls (PCBs).~   "
151999|NCT01576809|"~     This is an open label, in-use study to assess the warming sensation, acceptability and local~     tolerability of paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg syrup, given as~     a single dose in subjects suffering from symptoms of an upper respiratory tract infection.~     The purpose is to evaluate the acceptability concerning a warming sensation effect and its~     potential benefit in the target population.~      The primary objective is to assess the warming sensation caused by the excipient IFF flavor~     316 282, in a syrup containing paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg~     per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor.~      The Secondary Objectives are to assess subject acceptability of the syrup and the safety and~     tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from~     symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal~     congestion associated with colds and flu symptoms such as pain, headache and/or fever.~     Subjects must have one or more symptoms per category:~        1. mild to moderate body pain, headache, fever or sore throat~        2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing~        3. productive cough Adolescents will be included in the study population~   "
152000|NCT01576796|"~     This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in~     the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC~     not amenable to surgery and candidate for chemoradiotherapy.~      Preliminary studies in head and neck cancers have demonstrated the feasibility and support~     the medical benefit of this novel approach.~      The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement~     (boost) in this difficult medical condition for which only limited treatment options are~     available.~   "
152001|NCT01576783|"~     The purpose of this study is to examine whether supplementation with certain polyunsaturated~     fatty acids can help the cognitive development of children born preterm.~   "
152002|NCT01576770|"~     The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch),~     used to numb the skin before IV placement, is effective in reducing pain associated with~     propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl~     Chloride topical anesthetic skin refrigerant.~   "
152003|NCT01576757|"~     The purpose of this study is to determine whether the harvest, isolation and culture of~     cardiac stem cells from endomyocardial biopsies is feasible.~   "
152021|NCT01576523|"~     The aim of the study is to assess what happens to C1-esterase inhibitor that is administered~     under the skin of subjects with hereditary angioedema. Three different dosing regimens of~     C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3~     dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in~     the blood will be measured during each 4-week period. The study will also examine how well~     C1-esterase inhibitor administered under the skin is tolerated by the subjects.~   "
152004|NCT01576744|"~     Human epididymal secretory protein 4 (HE4) is a new biomarker for ovarian cancer. The effect~     of IVF stimulation will be evaluated in order to see whether severe hormonal changes in the~     gonadotrophin and steroid status affect the serum levels of this marker. Findings will be~     compared to serum concentrations of CA-125, which is currently the most often used marker for~     ovarian cancer.~      The intention is to determine the serum concentration of HE4 and CA-125 in serial samples in~     20 women undergoing IVF stimulation. Samples will be taken following GnRH agonist~     suppression, 2-3 times during FSH stimulation, at ovum pick up and two weeks following embryo~     transfer at the time of the hCG-test. The ovarian follicle count and the serum estradiol~     concentrations are recorded throughout the treatment. The serum biomarker HE4 is expected to~     ba a stable marker, which does not respond significantly to hormonal stimulation.~   "
152005|NCT01576731|"~     As a measure of secondary prophylaxis, and with the final objective of avoiding the~     infection, it has been suggested to use antiretroviral therapy. This is known as~     post-exposure prophylaxis (PEP).~      Although there are different recommendations, almost every guideline recommend using 3 drugs~     as PEP both in USA and Europe.~      Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are~     attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.~      A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus~     the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases),with a~     high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.~   "
152006|NCT01576718|"~     The primary objective of this study is to evaluate the dose response, efficacy and safety of~     4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as~     Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in~     subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high~     dose ICS therapy.~   "
152007|NCT01576705|"~     Evaluation of the following in very young children with Down syndrome:~        -  the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically~          and by ultrasensitive thyreostimulating hormone (TSH) assay),~        -  the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,~        -  any interaction between these two treatments.~   "
152008|NCT01576692|"~     This is a safety / feasibility trial evaluating the combination of a humanized anti-GD2~     antibody (HU14.18K322A) manufactured at the Children's GMP, LLC at St. Jude with allogeneic~     natural killer (NK) cells and standard chemotherapy in children with relapsed or refractory~     neuroblastoma.~   "
152009|NCT01576679|"~     The objective of this study is to establish the efficacy of tPA when used in pediatric~     intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the~     ultrasound appearance or consistency of the drained fluid.~   "
152010|NCT01576666|"~     The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be~     safely given together to patients and/or the dose that will be used in future studies. This~     study will also learn more about how the combination of these two investigational drugs may~     work for patients with certain cancers (specifically metastatic breast cancer, advanced~     pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma~     multiforme).~   "
152011|NCT01576653|"~     In patients with invasive fungal infection (IFI) rapid diagnosis is essential for early~     initiation of appropriate antifungal therapy and thereby survival. Conventional culture is~     still the Gold-Standard for diagnosis of IFI. Sensitivity of conventional culture, however,~     is low (50%) and time to results minimum 24 hours.~      Therefore usage of serological tests detecting fungal antigens has increased dramatically~     over recent years. Main advantages of this new methods are rapid results and higher~     sensitivity when compared to conventional culture. One of the most promising serological~     marker currently used is beta-D-Glucan, which is a component of the fungal cell wall.~     ß-D-Glucan has been detected in IFI caused by Aspergillus, Candida and Fusarium spp. The~     Fungitell Assay (Associates of Cape Code, Inc.) was developed and validated for detection of~     ß-D-Glucan in peripheral blood.~      Up to date information about clinical performance of the Fungitell Assays in bronchoalveolar~     lavage fluid (BAL) is limited. This study will therefore evaluate clinical and diagnostic~     performance of the Fungitell Assay in BAL from patients with solid organ transplant or~     hematologic malignancy.~      In addition Mn/A-Mn, the lateral flow device test for aspergillosis, and Galactomannan, as~     well as PCR will be determined and used as comparators for BDG performance.~   "
152012|NCT01576640|"~     After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse~     shortly after discontinuation of treatment. The purpose of this study was to assess the~     feasibility and effectiveness of a 12-month relapse prevention intervention in recently~     abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation~     phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and~     cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1~     week of abstinence, they continued in the relapse prevention phase of the study, where they~     continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive~     behavioral therapy.~   "
152013|NCT01576627|"~     The goal of this trial is to evaluate zinc citrate, a zinc compound with promising sensory~     properties and a high zinc content, as an alternative zinc compound to be used for~     supplementation or food fortification. The bioavailability of zinc citrate given as a~     supplement to young Swiss adults will be assessed and compared to the bioavailability of the~     commonly used zinc compounds zinc gluconate and zinc oxide.~   "
152014|NCT01576614|"~     Hypothesis: The use of a mobile robotic telepresence system for off-hours rounding in the~     surgical intensive care unit has an impact on nurse-physician collaboration.~      Study question: Does the addition of mobile video communication provided by RTP affect~     nurse-physician collaboration during off shift rounding in the surgical intensive care unit~     when compared to the more common clinical practice of off-shift rounding using the telephone?~   "
152015|NCT01576601|"~     The purpose of this prospective, clinical observational trial is to assess the incidence of~     pain (and analgesia), methods of pain assessment (and by whom), prescribed analgesics,~     methods of analgesic delivery, and patient/parent satisfaction in patients undergoing~     craniotomy surgery at three major children's hospitals (Boston Children's Hospital,~     Children's Hospital of Philadelphia, The Children's Center Johns Hopkins Hospital) in the~     United States.~   "
152022|NCT01576510|"~     To employ a fear learning-extinction paradigm with functional magnetic resonance imaging~     (fMRI) and skin conductance response (SCR) assessments among patients with posttraumatic~     stress disorder (PTSD) and trauma exposed healthy controls, aiming to a) clarify neural~     circuits underlying PTSD and b) to probe brain based predictors of symptomatic improvement in~     response to Prolonged Exposure (PE) treatment, and first line treatment for PTSD.~   "
152023|NCT01576497|"~     EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's~     preference, EUS-FNA with suction or without suction technique has been used. To date, little~     is known about optimal number of to-and-fro motion during each needle pass. As usual 10-15~     to-and-fro motions was used for EUS-FNA with suction technique. Theoretically, more number of~     to-and-fro motions may be required in EUS-FNA without suction. In this circumstance, the~     contamination of blood in specimen and possible adverse event may occur. To determine optimal~     number of to-and-fro motion in EUS-guided FNA for pancreatic masses in terms of with suction~     or without suction, this prospective single-blinded randomized trial was conducted.~   "
152024|NCT01576484|"~     This is a phase 2, open-label extension study to assess the long-term safety and efficacy of~     REGN727 (SAR236553) administered by subcutaneous (SC) injection in patients previously~     participating in the R727-CL-1003 study.~   "
152025|NCT01576471|"~     This is a randomized, double-blind, placebo-controlled, multicenter, and proof of concept~     study with a parallel group design to evaluate the safety and efficacy of oral Trichuris Suis~     Ova (TSO) suspension, as compared to placebo, in patients with moderately to severely active~     Crohn's disease. This study will also have an optional open-label extension for patients~     completing the double-blind phase of the study.~   "
152026|NCT01576458|"~     The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid~     (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).~      In the randomised (double-blind, placebo-controlled) study 20 pregnant women with ICP~     received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the~     third trimester of pregnancy. The severity of pruritus was registered. Itching scores and~     serum levels of alanine aminotransferase, total bile acids, estradiol, progesterone,~     prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time~     (APTT), fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and~     weekly thereafter. Data on pregnancy and delivery outcome was recorded and analysed.~   "
152027|NCT01576445|"~     When performing total knee replacement surgery, the surgeon has a choice as to which type of~     surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the~     so-called 'medial parapatellar' exposure. And alternative and more recently introduced~     technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the~     muscle at the front of the leg. In this study we compare the two surgical techniques in a~     so-called randomized trial. This means that we put people randomly into two groups, one group~     will receive surgery with the 'Mid-vastus approach' and the other group the surgery with the~     'Medial parapatellar approach'. It is hypothesized that people who receive the Mid-vastus~     approach recover quicker and have a better short-term functional outcome than people who~     receive the 'Medial parapatellar approach'.~   "
152028|NCT01576432|"~     Objective~      To investigate the analgesic effect (measured with NIPS) of breastfeeding in addition to~     skin-to-skin contact versus other methods of non-pharmacological analgesia during blood~     sampling through heel lance in healthy term neonates. The influences of non-pharmacological~     methods on crying time, percentage of crying while sampling, heart rate, number of attempts~     and duration of sampling were studied.~      Methods~      Randomised controlled trial performed on 136 healthy term newborns in the maternity ward of a~     tertiary hospital. The inclusion criteria were: healthy term neonates, wish to breastfeed and~     absence of feeding during the previous 60 minutes. Neonates were randomly assigned to four~     groups: group 1, breastfed with skin-to-skin contact ; group 2, oral sucrose with~     skin-to-skin contact ; group 3, skin-to-skin contact ; or group 4, receiving oral sucrose~     Data for the primary objective was analysed per intention to treat. This study was approved~     by local ethical committee.~   "
152029|NCT01576419|"~     The objective of this study was to to evaluate the efficacy and safety of PG201 in~     osteoarthritis patients.~      This clinical study was designated to be non-inferiority test with level of significance:~     95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%.~     Assuming 20% drop-out rate, the number of subjects required for each treatment group was~     estimated to be 154, while the total number of subjects required for the study 308.~      non-inferiority margin: 8mm~   "
152030|NCT01576406|"~     This study is designed to evaluate the potential effect of hepatic impairment on the~     pharmacokinetics and safety of crizotinib in advanced cancer patients. Advanced cancer~     patients with mild, moderate or severe liver dysfunction as well as patients with normal~     liver function will be enrolled in this study.~   "
152031|NCT01576393|"~     Given the reciprocal nature of parent-child interaction, involvement of the adolescent in~     their mother's substance abuse treatment plan might be associated with reductions in adult~     relapse and improvements in child functioning. These findings would support the assertion~     that focus on family dynamics in substance abuse treatment programs is an effective use of~     resources and an important target of intervention efforts. One hundred eighty-three substance~     abusing mothers and their child (n=61 assigned to each condition) will receive treatment as~     usual (TAU) and be randomly assigned to 1) Ecologically-based family therapy (EBFT) conducted~     in the home or 2) Ecologically-based family therapy conducted at the treatment center, or 3)~     an attention control, Women's Health Education (WHE). In order to examine the endurance of~     treatment effects, this project will assess the parent and child at 3, 6, 12, and 18 months~     post-baseline.~      Hypotheses~        1. It is expected that 1) mothers and children assigned to home and office based family~          therapy will show greater reductions in substance use and improvement in individual and~          family functioning at post-treatment compared to those in the attention control, and 2)~          those assigned to home-based family therapy will show greater reductions in substance~          use and improved individual and family functioning at post-treatment compared to those~          assigned to office-based family therapy.~        2. It is expected that 1) those assigned to home or office based family therapy will~          continue to maintain improvements in substance use, individual and family domains over~          time (time by treatment interaction) compared to those assigned to the attention control~          and 2) those assigned to home-based family therapy will continue to maintain~          improvements in substance use, individual and family domains over time (time by~          treatment interaction) compared to those assigned to office-based family therapy.~        3. It is hypothesized that improved family interaction skills will mediate substance use,~          individual and family outcomes.~        4. It is expected that EBFT in the home and EBFT in the office will be more cost effective~          than TAU, and that EBFT in the home will be more cost effective than EBFT in the office~   "
152032|NCT01576380|"~     This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof~     of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate~     efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma~     (SGC) that have progressed after one or two prior systemic treatments.~   "
152033|NCT01576367|"~     This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS~     patients that completed the CACZ885D2307 study~   "
152034|NCT01576354|"~     The objective of the present investigator-initiated mono-center trial to be performed at the~     Department of Neurology of the University Hospital Zurich is a detailed characterization of~     the effects of prolonged-release fampridine on walking function of 50-70 patients with MS. In~     a randomized, double-blind, placebo-controlled study with cross-over design, changes of~     essential gait elements such as stability, coordination, correct loading, posture or~     endurance in addition to walking speed after treatment with prolonged-release fampridine will~     be investigated using a comprehensive kinematic gait analysis protocol. This protocol~     comprises outcome parameters ranging from very specific and sensitive biomechanical measures~     to clinically meaningful indicators of improved ambulatory function. Kinematic, kinetic and~     electromyographic gait parameters will be assessed during treadmill walking (primary outcome~     parameters). Changes in overground walking capacity will be investigated by means of~     different functional walking tests (e.g. six minute walk test). Furthermore, the patient's~     perception of the effects of the treatment on walking function will be evaluated by a~     standardized questionnaire. Changes of global ambulatory activity will be assessed~     (Actimeter) indicating a successful translation of improved gait (sub-)functions due to~     prolonged-release fampridine treatment into everyday life. The study will last for a period~     of 18 weeks, excluding the screening period. Based on the mechanism of action, the~     investigators hypothesize that treatment with prolonged-release fampridine will not only~     improve walking speed, but also clinically more meaningful features of walking function in~     patients with MS.~        -  Trial with medicinal product~   "
152035|NCT01576341|"~     The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa~     administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney~     disease (CKD)~   "
152036|NCT01576328|"~     This study is being conducted to assess the overall safety and tolerability of a single~     intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects~     with Type 2 Diabetes inadequately controlled on Metformin.~   "
152037|NCT01576315|"~     Aspergillus infection is an infectious complication which frequently occurs in cystic~     fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent~     positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole~     and voriconazole in this indication has never been evaluated in a large prospective~     controlled clinical trial, even though many teams already use it. The ATCF study aims to~     assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the~     efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for~     Aspergillus.~   "
152038|NCT01576302|"~     Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent~     regurgitation of recently ingested food. Very little is understood about the nature and~     treatment of this disorder. The act of regurgitation in rumination involves the opening of~     the upper esophageal sphincter and the muscular contraction of the abdomins rectus.~     Behavioral treatment of these symptoms is the clinical intervention of choice; however, only~     uncontrolled case documentation exists to support its effectiveness. However, an effective~     behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint, muscular~     relaxation is incompatible with the necessary muscular contraction for rumination.~      To date, single case documentation and few designed single case studies have examined the~     clinical effectiveness of behavioral interventions for GI rumination. In the current study,~     the investigators seek to examine the effectiveness of two behavioral relaxation~     interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our~     primary goals are to examine the clinical effectiveness of these interventions in symptom~     reduction at 1- and 3-month follow-up.~   "
152039|NCT01576289|"~     Multicenter study to correlate histological findings in the upper gastrointestinal tract with~     endoscopic and clinical data.~   "
152040|NCT01576276|"~     Healthy right-handed volunteers aged 21 to 50 needed for a research study of the effects of~     morphine and ketorolac on brain activity in response to pain stimuli as measured by~     functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). Study~     will be conducted on six separate days not requiring an overnight stay in the hospital.~   "
152041|NCT01576263|"~     Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications~     even in elderly patients with previous or current medical conditions. Especially comorbidity~     like cardiovascular diseases and conditions with increased risk of bleeding or previous~     thrombo-embolic events are major challenges.~      To facilitate safe use of ropivacaine as an analgesic, information on the concentrations~     levels after autologous blood transfusion following local infiltration analgesia is very~     crucial. However, very limited data are available. To verify the safety of autologous blood~     transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total~     knee arthroplasty or total hip arthroplasty.~   "
152042|NCT01576250|"~     The purpose of this study is to investigate the effects of lowered physical activity~     (resulting in decreased muscle mitochondrial oxidative capacity) alone and together with~     increased plasma free fatty acid availability (by infusion of a clinically widely used lipid~     emulsion (Intralipid)) on insulin sensitivity and glucose and lipid metabolism. To this end,~     we will compare skeletal muscle insulin sensitivity and glucose and lipid metabolism (within~     one subject) after 9 days of immobilization of one leg (unilateral lower limb~     suspension(ULLS))(decreased muscle mitochondrial oxidative capacity) versus an active control~     leg (unchanged muscle mitochondrial oxidative capacity). Further, changes in IMCL and fatty~     acid intermediates will be investigated in the immobilized vs the control leg, and this will~     be related to insulin sensitivity. The effectiveness of the ULLS intervention will be tested~     by measuring muscle mitochondrial oxidative capacity in both the immobilized and the control~     leg. All measurements will be performed both in the immobilized and control leg after 9 days~     of ULLS.~   "
152043|NCT01576237|"~     During a five years period the participating transfusion medicine establishments will report~     all their non-trivial adverse events (AE) occurring during preparative hemaphereses.~     Complications may be related to the blood donors, the blood products, the disposables or the~     apheresis devices. The study hypothesis regarding each participating center is that their~     procedure-related AE rate is not higher than the respective rate of all other centers in~     total.~   "
152367|NCT01571986|"~     A single center, observational, prospective study to improve knowledge about non-invasive~     ventilation, obtaining data about compliance, efficacy, imaging in patients who already~     receive non-invasive ventilation as standard of care.~   "
152044|NCT01576224|"~     The aim of this study is to investigate the post operational mobilization after volar locking~     plate osteosynthesis of distal radius fractures. One group is admitted training exercises~     just after the fracture treatment, one group after 14 days immobilization in a cast.~      The primary hypothesis is, that immediate training leads to earlier and faster recovery.~      Our second hypothesis is, that immediate training does not lead to increased risk of fracture~     displacement.~   "
152045|NCT01576211|"~     RATIONALE: Studying samples of blood and tissue from newborns and from patients with cancer~     in the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies cord blood and placenta tissue from newborns, and tumor~     tissue samples from patients with Wilms tumor.~   "
152046|NCT01576198|"~     RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the~     laboratory may help doctors to learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms~     tumor.~   "
152047|NCT01576185|"~     These laboratory trial studies the development and treatment of a mouse model for acute~     myeloid leukemia (AML) using samples from younger patients with AML. Studying tissue samples~     from patients with cancer in the laboratory may help doctors learn more about cancer and how~     well patients will respond to treatment.~   "
152048|NCT01576172|"~     This randomized phase II trial studies abiraterone acetate and prednisone together with~     veliparib to see how well it works compared to abiraterone acetate and prednisone alone in~     treating patients with castration-resistant prostate cancer that has spread from the primary~     site to other places in the body. Androgens can cause the growth of prostate cancer cells.~     Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by~     the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving abiraterone acetate together with prednisone and veliparib may work~     better than abiraterone acetate and prednisone alone in treating patients with~     castration-resistant prostate cancer.~   "
152049|NCT01576159|"~     Acute effects of physical exercise on the deformational behavior of articular cartilage and~     changes in cartilage oligomeric matrix protein (COMP) are definite. However, conclusive~     positive effects of fitness exercise on functional adaptation of articular cartilage have not~     been proved.Therefore, in this parallel-group randomized control trial, the investigators~     tested the hypothesis that adequate amount of physical exercise with enough impact would be~     able to stimulate the functional behavior of articular cartilage.~      The investigators evaluated 44 healthy males for their physical fitness levels and their~     blood samples were obtained before, immediately after and 0.5 h after a 30-min walking~     exercise. Thereafter, participants were assigned to the running, the cycling, the swimming~     and the control groups. At the end of 12-weeks of intervention, same measurement procedures~     were applied. Mixed repeated-measures ANOVA design was used for statistics. (Level of~     evidence: 2)~   "
152050|NCT01576146|"~     The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly~     intravenous (IV) administration of etelcalcetide in the treatment of secondary~     hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of~     treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).~   "
152051|NCT01576133|"~     The purpose of the study is to determine whether a combination of occupational therapy~     visits, nursing visits, and handyman repair are effective in helping low income older adults~     avoid costly health care services~   "
152052|NCT01576120|"~     The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using~     the PillCam Colon system.~   "
152053|NCT01576107|"~     Impact of a 4-week exercise intervention vs. a stress-management-training on physical~     activity (measured objectively and by questionnaire) of cancer patients of different entities~     and out-patient regimes.~   "
152054|NCT01576094|"~     Congenital heart defects are the most prevalent group of congenital malformations in~     newborns. Surgery-related low cardiac output syndrome (LCOS) could be one of the reason for~     the unfavourable outcome of this population. The early use of inodilators (INDs),~     specifically milrinone (MR), is proposed to reduce afterload and increase inotropism. Studies~     in the paediatric population appear to support a clinical usefulness of MR similar to that~     observed in adults. Levosimendan (LEVO) is a novel class IND developed for the treatment of~     heart failure. Experience with LEVO in paediatric patients is scarce. The purpose of this~     study was to systematically test the efficacy and safety of milrinone (MR) and levosimendan~     (LEVO) in newborns undergoing cardiovascular surgery with cardiopulmonary bypass (CPB). Given~     the uncertainty about LEVO pharmacokinetics in neonates, the study was designed as a pilot,~     phase I feasibility study.~   "
152055|NCT01576081|"~     The present study aimed to investigate the importance of gravitational induced forces that~     appear during normal ambulation for the health of muscles, bones and blood vessels. The main~     hypothesis of the present study is that gravitational loading alone, without muscle~     contractions, is insufficient to maintain bone strength.~   "
152056|NCT01576068|"~     Chronic Obstructive Pulmonary Disease (COPD) is a prevalent disease. In the investigators~     country, underdiagnosis has been estimated in around 80% of subjects. Early detection is done~     mainly in primary care but due to actual situation new alternatives have been proposed to~     decrease underdiagnosis.~      This present study promote by a multidisciplinary research team (respiratory medicine,~     primary care, nurse and pharmacist) raise the objective of evaluate the effect of a COPD case~     finding program guide by spirometry in community-pharmacies.~      From the results of a pilot-study conducted in 13 community-pharmacies in Barcelona, in which~     the investigators showed the feasibility of spirometry in community-pharmacies for the early~     detection of COPD, the investigators have design a second phase to evaluate the effect of~     this strategy. 100 Barcelona's community-pharmacies during 6 months will select high risk~     customers and will conduct a spirometry in agreement with the design protocol. 3600~     spirometries is the establish objective. Participants hospitals will train pharmacist in~     spirometry and also control spirometry quality daily by a telematic pathway. Spirometry~     results will be evaluate in terms of effect and costs. The investigators will also evaluate~     the impact of this program in the health system by numbers of subjects diagnosed and follow~     up in primary care.~   "
152368|NCT01571973|"~     The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of~     depressed outpatients.~   "
152058|NCT01576042|"~     The purpose of this pilot trial is to determine the feasibility of a large, multi-center~     randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter~     ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic~     therapy at reducing all-cause mortality in patients with an implantable cardioverter~     defibrillator (ICD) who receive therapy for VT in the absence of any reversible cause.~   "
152059|NCT01576029|"~     Primary Objective:~        -  To compare the continuation of treatment with docetaxel versus switching to cabazitaxel~          regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in~          patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of~          docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or~          increase of up to 24% in PSA levels.~      Secondary Objectives:~        -  PSA response rate~        -  Overall survival (OS)~        -  Incidence of Adverse Events~   "
152060|NCT01576016|"~     The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety~     and efficacy of the Accent MRI™ System in a patient population indicated for implant of a~     pacemaker within and outside of the MRI environment.~   "
152061|NCT01576003|"~     The purpose of this research study is to evaluate the effects (good and bad) of~     supplementation with Glutamine to that of a placebo (L-alanine), on your child and their~     Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to~     oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections,~     improving growth, and/or changing the make-up of bacteria in your child's intestine.~     Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study,~     the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in~     children.~   "
152062|NCT01575990|"~     The purpose of this research study is to explore ways to improve appropriate colorectal~     cancer (CRC) screening in the elderly by attempting to target screening in those most likely~     to benefit and avoiding screening in those least likely to benefit.~   "
152063|NCT01575977|"~     The main objective of this study is to predict cartilage contact pressures in the hip after~     periacetabular osteotomy (PAO).~   "
152064|NCT01575964|"~     The purpose of this study is to determine the influence of FAI abnormalities on hip joint~     biomechanics.~   "
152065|NCT01575951|"~     This is a pilot study to determine the diagnostic value of dynamic contrast enhancing MRI~     (DCE-MRI) in soft tissue sarcoma for assessment of tumor radiographic changes in vascular~     permeability and microvessel density before and after preoperative radiotherapy.~   "
152066|NCT01575938|"~     The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction~     intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition or~     transmission.~   "
152067|NCT01575925|"~     The purpose of this study is to determine the pharmacokinetics (PK) and safety for the~     combination of pomalidomide (POM) + low-dose dexamethasone (LD-DEX) in subjects with relapsed~     or refractory Multiple Myeloma (RRMM) and impaired renal function.~   "
152068|NCT01575912|"~     Differences in pain perception between subjects with and without psychiatric illness may be~     influenced by the individual experience, and not primarily by the pathology, although the~     pathological frame may amplify it.The aim of this study is to establish if the~     characteristics of experimental pain feeling are influenced by the past pain experience,~     anxiety and emotion, independently from the diagnosis. The pain experience will be evaluated~     by an inventory of the potentially painful situations that one can come across through the~     life, to determine the following points : Number of painful events in the past, number of~     painful points during the last 6 months, number of painful events lasting more than 6 months,~     sum of pain intensities (graduated with Visual Analogic Scale VAS from 0 to 10), sum of~     gravity (evaluated from 0 to 5), the category of pain experience qualification (mostly~     affective, mostly sensorial, or both).~      Schizophrenic, depressed and control participants will be recruited, and their pain~     experience throughout life will be put it in relation to experimental pain tests results~     (pressure application, ischemia induction), anxiety and emotion (Hospital Anxiety and~     Depression scale HAD), catastrophizing (Pain Catastrophizing Scale PCS), Heart Rate (HR)~     variation, Blood Pressure (BP) variation.~   "
152069|NCT01575899|"~     This prospective controlled randomized open-label clinical trial is designed to determine the~     eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen~     compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in~     Eastern Taiwan.~   "
152070|NCT01575886|"~     The goal of this study is to test an intervention that teaches clinicians to integrate the~     use of 'teachable moments' with the key skills of motivational interviewing tailored to~     address smoking and weight management in the primary care outpatient visit setting.~   "
152071|NCT01575873|"~     This study is being conducted in patients taking glucocorticoids for treatment of various~     diseases. It is a 2-year study that will compare the effects of denosumab and risedronate.~   "
152072|NCT01575860|"~     This study is being conducted to evaluate the overall safety of lenalidomide (also known as~     Revlimid) in patients with lymphoma, and to determine whether it is effective in preventing~     this disease from returning after stem cell transplant. This study will also determine the~     dose of lenalidomide that can be given without causing severe side effects. Lenalidomide has~     not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of~     lymphoma. At least 28 people will be enrolled on this study at the University of~     Pennsylvania.~   "
152085|NCT01575691|"~     5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS).~     Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the~     effects of 5-aza. The goal of this clinical research study is to find the highest safe dose~     of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and~     all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness~     of this combination therapy will also be studied.~   "
152086|NCT01575678|"~     Aim: To investigate the effect of melatonin in bedwetting.~   "
152127|NCT01575119|"~     Smokers have three choices when faced with surgery: keep smoking, quit for a short time~     around surgery or quit for good. In the first specific aim, a decision aid was designed to~     help facilitate the discussion of these choices between smokers and healthcare providers.~     This second aim will test whether this decision aid improves the decisional quality compared~     with standard methods used to discuss perioperative smoking.~   "
152073|NCT01575847|"~     This study is a non-intervention, clinical study to test research use only APAP protein~     adducts dipsticks in human blood samples. The study will be conducted in two phases. In phase~     1, the research use only dipsticks and dipstick testing components will be tested for~     feasibility in the emergency department at UAMS. Patients will be enrolled that are having an~     acetaminophen level obtained as part of their medical evaluation. In phase 2, the research~     use only dipsticks will be tested in centers that participate in the Acute Liver Failure~     Study Group (ALFSG), a clinical research network funded by the National Institutes of~     Diabetes, Digestive and Kidney Diseases (NIDDK). Subjects participating in the clinical~     registry of the ALFSG will be approached for enrollment. These patients all have the~     diagnosis of acute liver failure or acute liver injury from a variety of etiologies,~     including APAP. A single blood sample will be obtained and will be aliquoted for 1) testing~     by the dipstick and 2) testing by high performance liquid chromatography with electrochemical~     detection (HPLC-EC) analysis for APAP protein adducts. APAP levels will also be determined~     from the second aliquot of blood. In both Phase 1 and Phase 2, the dipsticks will be read~     manually and by dipstick readers by independent testers that are not directly involved in the~     clinical care of the patients. The results of the two dipstick readings will be recorded,~     will remain confidential and will not be used in the diagnosis or management of the patient.~     The results of the dipsticks and HPLC-EC assays will be compared to the final patient~     diagnoses.~   "
152074|NCT01575834|"~     The purpose of this study is to determine if treatment with romosozumab is effective in~     preventing fractures in women with postmenopausal osteoporosis~   "
152075|NCT01575821|"~     Cough is a common symptom in pediatric practice. It can be particularly troubling to children~     and their parents.It often results in discomfort to the child and loss of sleep to both the~     child and the parent. The objective of this trial was to compare the effects on nocturnal~     cough and the sleep difficulty associated with URIs of a single nocturnal dose of three~     different honey products compared to placebo~   "
152076|NCT01575808|"~     The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment~     of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be~     measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured~     by comparison to Surgical Bypass data derived from a retrospective study.~   "
152077|NCT01575795|"~     This is a multi-center, prospective, randomized, single-blind, investigator initiated,~     pharmacodynamic study of parallel design, performed at 3 institutions (Patras University~     Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).~      Patients with ST elevation myocardial infarction (symptom onset < 12 hours), undergoing~     primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present~     high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary~     intervention, will be randomized after informed consent, in a 1:1 ratio to either:~      Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting 12±6~     hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance dose~     (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at~     randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow~     assay, in platelet reactivity units (PRU).~      Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent~     revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic~     Research Consortium criteria) will be performed until patient's discharge.~   "
152078|NCT01575782|"~     Chloroquine can make tumor cells less resistant to chemo/radiotherapy. In this trial~     chloroquine is given during radiotherapy. The dose is increased in cohorts of at least 3~     patients.~   "
152079|NCT01575769|"~     This long-term, interventional, open-label extension study will evaluate the safety and~     efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with~     polyarticular-course juvenile idiopathic arthritis who completed the WA19977 study. Patients~     will receive RoActemra/Actemra 8 mg/kg every 4 weeks. The anticipated time on study treatment~     is 104 weeks.~   "
152080|NCT01575756|"~     The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy~     and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital~     fibrinogen deficiency~   "
152081|NCT01575743|"~     The aim of the present study is to investigate the impact of regular aerobic exercise on~     psychopathology, cortisol secretion, BDNF, sleep, cognitive performance, and psychological~     functioning in people suffering from professional burnout. Pre- and postassessments after 12~     weeks of training will be performed.~   "
152082|NCT01575730|"~     Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable~     patients with surgery followed by instillation of heated chemotherapy inside the abdominal~     cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or~     HIPEC. Many center perform HIPEC with high dose oxaliplatin, a standard chemotherapy drug~     active against colon cancer, administered during 30 minutes at 41°C. The hypothesis of this~     study is, that chemoperfusion at normal (37.5°C) temperature but longer duration (90 minutes)~     may be safer and at least as efficient. Patients will be treated with one of three possible~     HIPEC regimens using oxaliplatin: high dose, 30 min, 41°C; high dose, 30 min, 37.5°C; or low~     dose, 90 min, 37.5°C. The outcome parameters are pharmacokinetic and pharmacodynamic: using~     specialized techniques, tissue penetration of chemotherapy and cancer cell kill effects will~     be compared in order to establish the safest and most active HIPEC regimen.~   "
152083|NCT01575717|"~     The purpose of this study is to investigate the effect of two different doses of vitamin D3~     (2000 IU vs. 4000 IU) on serum 25-hydroxyvitamin D (25OHD) levels in patients with~     hepatocellular carcinoma on the liver transplant list. The study will help determine the dose~     of vitamin D3 that is required for patients with liver cancer to reach a normal level of~     25OHD in the blood.~   "
152084|NCT01575704|"~     The purpose of this randomized controlled two-part study examines the effects of a structured~     sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in~     children and adolescents.~      The main aspects in the sports groups are resistance, endurance and flexibility training. The~     control group performs a mental training as well as relaxation exercises.~   "
152128|NCT01575106|"~     This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how~     contextual learning/expectation relieves or aggravates pain experience in the same cohort of~     subjects and the same study session.~   "
152087|NCT01575665|"~     Background: Chronic Idiopathic Hyperventilation (CIH) is a form of dysfunctional breathing~     which has proven hard to treat effectively. The investigators hypothesised that by~     periodically inducing normocapnia over several weeks, it would be possible to raise the~     normal resting level/set point of CO2 and achieve a reduction of symptoms.~      Methods: Six CIH patients were treated two hours a day for four weeks with a novel breathing~     mask. The mask was used to induce normocapnia in these chronically hypocapnic patients.~      Capillary blood gases (PcCO2, pH, Standard Base Excess (SBE) etc.) were measured at baseline~     and once each week at least three hours after mask use, as well as spirometric values, breath~     holding tolerance and hyperventilation symptoms as per the Nijmegen Questionnaire (NQ),.~   "
152088|NCT01575652|"~     The objective of this study was to examine the effects of angiotensin converting enzyme~     inhibitors on peritoneal membrane transport, peritoneal protein loss, and proteinuria in~     peritoneal dialysis patients.~   "
152089|NCT01575639|"~     Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal~     treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no~     consensus on the dosage of Prednisolone required for the treatment of infantile spasms.~     Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual~     dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses.~     A higher steroid dose may also be associated with more side effects. Therefore, this study~     was planned to compare the efficacy and tolerability of the high dose versus the usual dose~     in children with infantile spasms, in a randomized open-label trial design~   "
152090|NCT01575626|"~     One important goal in anesthetic management during ocular surgery is to provide adequate~     control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients~     with glaucoma or a penetrating open-eye injury. There is an ongoing debate over the effect of~     anesthetic agents on the IOP. Anesthetic regimens in this surgical field commonly consist of~     short-acting anesthetic agents, such as propofol and sevoflurane, usually combined with~     short-acting analgesics, such as remifentanil. Both propofol and sevoflurane are known to~     reduce the IOP. To this end there is no data in the literature to support or disprove this~     finding.~      Study Hypothesis Variations in the end-tidal sevoflurane concentrations have no significant~     effect on the IOP.~   "
152091|NCT01575613|"~     In this study, the investigators propose to determine the value of rolling out four targeted~     malaria control efforts in reducing overall malaria transmission. These targeted control~     efforts include local upscaling of IRS and ITNs in hotspots of malaria transmission. In~     addition, larviciding will be employed to target malaria vectors, also those that are less~     susceptible to IRS and ITNs as a consequence of outdoor feeding and resting. Lastly, the~     human infectious reservoir will be reduced in hotspots of malaria transmission by treating~     parasite carriers and their household members with the current first-line antimalarial drug.~     The impact of these targeted interventions on overall transmission intensity will be assessed~     in the context of currently ongoing malaria control activities in a plausibility study.~     Hotspots of malaria transmission are defined in an area of 100km2 and randomized to receive~     hotspot targeted interventions and compared with their baseline and with control clusters~     where the routine (untargeted) malaria control activities continue. The interventions will be~     evaluated based on changes in parasite prevalence measured in community surveys inside and~     outside hotspots of malaria transmission. Parasite prevalence will be compared before and~     after the intervention in intervention clusters and between intervention and control~     clusters.~      In addition to malaria surveys in the human population, an entomological evaluation will take~     place where the densities of mosquito larvae and adult mosquitoes are monitored~     longitudinally.~   "
152092|NCT01575600|"~     The purpose of this randomized clinical trial is to evaluate the interaction of intravenous~     fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The~     hypothesis is that perioperative supplemental intravenous fluid administration reduces the~     incidence of postoperative vomiting.~   "
152093|NCT01575587|"~     The purpose of this study is to evaluate the effect of timing of food intake on systemic~     abiraterone exposure observed in healthy adult Japanese and Caucasian men.~   "
152094|NCT01575574|"~     This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of~     hepatocellular carcinoma~   "
152095|NCT01575561|"~     This is an open-label, multi-center,12 week extension study designed to evaluate the longer~     term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to~     lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either~     completed the core study D1050296 or experienced a protocol defined recurrence of a mood~     event in the double-blind phase of the core study D1050296~   "
152096|NCT01575548|"~     This randomized phase III trial studies how well pazopanib hydrochloride works compared to~     placebo in treating patients with kidney cancer that has spread to other parts of the body~     and have no evidence of disease after surgery. Pazopanib hydrochloride may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow~     to the tumor.~   "
152097|NCT01575535|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research trial studies bone marrow samples from women with acute myeloid~     leukemia.~   "
152098|NCT01575522|"~     This phase II trial studies how well tivantinib works in treating patients with recurrent or~     metastatic breast cancer. Tivantinib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
152099|NCT01575509|"~     This study aims to determine the 2 hour glycemic responses of two bread products and one~     dried lingonberry product. The average postprandial response of each product is compared with~     glycemic response after ingestion of control solution with a similar carbohydrate content~     (glucose, glucose-fructose) as the provided by the respective test product.~   "
152100|NCT01575496|"~     The purpose of this study is to determine if repeated sessions of transcranial direct current~     stimulation (tDCS) are effective for treating chronic subjective tinnitus. Previous studies~     have reported brief improvements in tinnitus after safe and noninvasive stimulation of the~     auditory cortex or limbic system. The investigators hypothesize that a greater improvement in~     tinnitus will be achieved following repeated sessions of tDCS that target both auditory and~     limbic systems.~   "
152103|NCT01575457|"~     The purpose of the Harriet Lane Clinic Healthy Futures Program is to increase academic or~     workforce development success among adolescents and young adults. To this end, the Healthy~     Futures educational intervention includes motivational interviewing and knowledge and skill~     building activities that will focus on improving educational, vocational, health, and self~     sufficiency outcomes for youth who attend the Harriet Lane Clinic. Goals of this youth~     development project include determining what factors are associated with school engagement,~     parental academic involvement, and future planning.~   "
152104|NCT01575444|"~     This proposal has been developed through collaboration between the University of Minnesota~     and New American Community Services (NACS), and the research design is based on a needs~     assessment conducted by the community partner. The investigators will test the hypotheses~     that women who are offered home vaginal bio-specimen collection will have higher rate of~     cervical cancer screening completion than that of women referred for clinic-based Pap test.~     All participants will be given identical education materials on cervical cancer screening and~     HPV, currently in use by the Minnesota Sage Program.~   "
152105|NCT01575431|"~     The aim of this study is to prospectively investigate the relationship of circulating~     endothelial progenitor cells at time of percutaneous coronary intervention to the subsequent~     development of in-stent restenosis or progression of coronary atherosclerosis.~   "
152106|NCT01575418|"~     This is a double-blinded, randomized, pharmacokinetic and safety study of 3 rectally applied~     tenofovir microbicide formulations: a vaginal formulation (VF), a reduced glycerin vaginal~     formulation (RGVF), and a rectal-specific formulation (RF). Nine HIV-negative men will be~     enrolled.~      Each participant will receive two inpatient doses of each radiolabeled study product. The~     first inpatient dose of each product will be administered without coital dynamics simulation~     (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post~     dose with instillation of radiolabeled autologous semen. There will be a washout period of at~     least 11 days between each dose.~   "
152107|NCT01575405|"~     This is a double-blinded, randomized, safety, acceptability, pharmacokinetic, and ex vivo~     efficacy study of three rectally-applied tenofovir-based microbicide formulations.~     Approximately 18 total evaluable HIV-negative men and women (~9 per site) will be enrolled~     across two study sites: University of California at Los Angeles (UCLA) and Magee-Womens~     Research Institute (MWRI) at University of Pittsburgh.~      Each participant will experience seven rectal exposures to the rectal-specific formulation~     (RF) and seven rectal exposures to the reduced glycerin vaginal formulation (RGVF) of~     tenofovir 1% gel, but only one exposure to the vaginal formulation (VF), which will be~     coupled with six preceding exposures to the Universal HEC Placebo Gel to balance out the VF~     study stage. Participant accrual will take approximately 6 months and each participant will~     be on study for approximately 3 months. The total duration of the study will be approximately~     1 year.~      The primary objectives of the study are safety, acceptability, and pharmacokinetics,~     specifically:~        -  To evaluate the safety of each tenofovir-based microbicide gel formulation when applied~          rectally~        -  To evaluate the acceptability of each tenofovir-based microbicide gel formulation when~          applied rectally~        -  To compare systemic and compartment pharmacokinetics among the three tenofovir-based~          microbicide gel formulations when applied rectally~      Secondary objective of the study is to evaluate the mucosal immunotoxicity of each~     tenofovir-based microbicide gel formulation when applied rectally.~      And the exploratory objective of the study is to assess the preliminary (ex vivo) efficacy of~     each tenofovir-based microbicide gel formulation using biopsy explants after each product is~     applied rectally.~   "
152108|NCT01575392|"~     In clinical practice the 24-hour creatinine clearance is often used to obtain an impression~     of renal function. However, the glomerular filtration rate is considered to be the best~     indicator of renal function. For practical and financial purposes, GFR is often estimated by~     means of serum creatinine based equations. These equations are also used in internation~     guidelines to define and classify chronic kidney disease. Therefore, accurate creatinine~     measurements are important to make reliable estimates of renal function. However, previous~     research has revealed a large variability in creatinine measurements using different~     measuring methods. In this study the investigators aim to establish the degree of variability~     in different methods to measure creatinine in a heterogenous group of Caucasian people with~     and without renal function loss and the influence of this variability on renal function~     estimating equations and the 24-hour creatinine clearance.~   "
152109|NCT01575366|"~     Aim 1. Determine whether higher-velocity finger tracking training improves hand function more~     than slower velocity training. Working hypotheses: The higher-velocity training will have~     significantly greater functional improvement compared to the lower-velocity training, as~     measured by standardized upper extremity functional tests (Jebsen Taylor test, Box & Block~     Test, and Finger extension force test)~      Aim 2. Ascertain whether higher-velocity finger tracking training differentially induces~     cortical reorganization as compared to lower-velocity finger tracking training.~      Working hypotheses: The higher-velocity training will have significantly greater cortical~     reorganization compared to the lower-velocity training, as measured by:~        1. TMS - increased amplitude of motor evoked potentials (MEP) from paretic extensor~          digitorum muscle in response to paired-pulse TMS to ipsilesional primary motor area~          (M1).~        2. fMRI - increased volume of activation, signal intensity, and laterality of ipsilesional~          M1.~      Aim 3. Explore whether the functional improvements correlate with the cortical~     reorganization. Working hypotheses: The functional improvements will correlate with the~     cortical reorganization.~   "
152110|NCT01575353|"~     The aim of the study is to compare two devices for oxygen therapy, nasal high-flow and~     Venturi mask, in critically ill patients in the post-extubation period. The hypothesis is~     that nasal high-flow may be superior to the Venturi mask in terms of oxygenation~   "
152111|NCT01575340|"~     The purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish oil~     modifies inflammatory markers in individuals with colorectal cancer in chemotherapy~   "
152129|NCT01575093|"~     This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2~     Capsule Endoscopy.~   "
152130|NCT01575080|"~     The purpose of this study is to determine if untrained subjects who have diabetes can operate~     the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.~   "
152131|NCT01575067|"~     The purpose of this study is to monitor the blood pressure level of the patient using a~     preformed cuff ranged 22 cm-42 cm.~   "
152112|NCT01575327|"~     The purpose of this study is to investigate the benefit of Closed-loop System for Oxygen~     Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test in~     patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and hypercapnia.~      The study was designed to test the following hypotheses:~      As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to higher~     exercise tolerance (distance during ESWT) and lower desaturation events without increase in~     hypercapnia in patients with COPD, oxygen therapy and hypercapnia.~      As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower dyspnea~     and leg fatigue scores at a given endurance time during the shuttle walking test in patients~     with COPD, oxygen therapy and hypercapnia.~      As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower cardiac~     and respiratory frequencies at a given endurance time during the shuttle walking test in~     patients with COPD, oxygen therapy and hypercapnia.~   "
152113|NCT01575314|"~     The purpose of this study is to compare the efficacy and cost difference of using a~     parenchymal stapling device versus hand sewing for a pulmonary lobectomy in patients with~     lung disease (mass or others).~   "
152114|NCT01575301|"~     The purpose of this study is to collect a cohort of patients treated with GLP-1R Agonists and~     to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these agents.~   "
152115|NCT01575288|"~     The proposed study will assess the ability of a naturally occurring sugar to improve the~     function of arteries with age. Overall, the proposed research project has the long-term~     potential to influence clinical practice guidelines by establishing a novel, easy to deliver,~     cost-effective therapy for treating age-associated arterial dysfunction and reducing the risk~     of cardiovascular disease with age.~   "
152116|NCT01575275|"~     The purpose of this study is to investigate the safety and performance of an investigational~     agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for~     visualizing a tumor during surgery. It is also being studied to determine if there are~     differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance~     imaging (MRI)~   "
152117|NCT01575262|"~     The purpose of this study is to investigate the effectiveness of using incentives to~     encourage adults to be physically active.~   "
152118|NCT01575249|"~     The investigators aim to identify all clinical, biological, echo and imagistic parameters~     that predispose to increased progression rates in a prospective observational trial which~     will include ONLY patients with moderate AS, with the complete cardiological investigational~     tools provided in 2012. Once those parameters are found, medical and interventional treatment~     could be implemented to decrease the mortality rates.~   "
152119|NCT01575236|"~     The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure,~     fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the~     LMA SupremeTM in paralyzed, anesthetized patients.~   "
152120|NCT01575223|"~     Purpose: To determine if high volume saline nasal irrigation (HVSI), (NeilMed® Sinus Rinse™)~     offers a benefit over low volume saline irrigation (LVSI), (Salinex®) in the early~     post-operative management in patients with chronic rhino sinusitis.~   "
152121|NCT01575197|"~     The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on~     alternate dosing schedules will enhance the immune response to the vaccine in a low-resource,~     high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose~     vaccine schedule at a slightly older age and giving an additional dose of the vaccine.~   "
152122|NCT01575184|"~     Internal jugular vein (IJV) catheterization is frequently performed in infants undergoing~     major surgery. Although it has been suggested that head rotation increases the degree of~     overlapping between IJV and carotid artery (CA), IJV catheterization without head rotation is~     extremely difficult in infants. The aim of the present study is to evaluate whether the~     caudo-lateral traction of the ipsilateral arm can decrease the degree of overlapping between~     IJV and CA in infants during head rotation.~   "
152123|NCT01575171|"~     Behavioral economics represents a powerful, albeit underutilized tool to influence provider~     and systems behavior in a large-scale, meaningful, and sustainable way. The investigators~     propose to use a sophisticated electronic health record (EHR) system to change the default~     choice for physicians to the choice most supported by clinical practice guidelines (CPG).~      Multiple guidelines exist describing best practices for effective interventions, yet a large~     gap persists between actual and optimal guideline compliance. The proposed study will examine~     the comparative effectiveness of an opt-out medication management protocol relative to usual~     care for patients not at goal, using national guidelines for cholesterol management~     implemented in large multispecialty private practices that use an Electronic Health Record~     system.~      Specific Aim: To determine the effectiveness of altering the default option in an EHR in~     prescribing statins to selected patients using clinical decision support.~      Hypotheses: Compared to usual care, a CPG-concordant intervention designed using behavioral~     economics principles will significantly improve the proportion of patients who are prescribed~     statins.~   "
152124|NCT01575158|"~     citalopram and clomipramine are better than placebo in preventing new episodes of depression~     in patients with recurrent depression~   "
152125|NCT01575145|"~     The study is being done to determine whether an in-hospital intervention using a brief~     intervention to facilitate quitline utilization will increase quitline utilization by~     hospitalized smokers, and will increase post hospital discharge smoking abstinence rates.~      Study participants will be randomized to receive either a brief quitline facilitation~     intervention , or a control intervention of a brief stop-smoking message.~      The study will also compare healthcare costs and utilization in the first six months~     following hospitalization between the two groups.~   "
152126|NCT01575132|"~     The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS)~     for patients with Parkinson's Disease. We have data for patients operated with DBS since~     1998. We wish to examine the effect of stimulation on motor symptoms as well as make a~     follow-up on complications and side-effects related to treatment. We also wish to follow-up~     on the quality of life-studies made in the years 2003-2008.~   "
152132|NCT01575054|"~     This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult~     post-stroke lower limb spasticity.~   "
152133|NCT01575041|"~     To determine the effect of (1) increased sodium intake and (2) increased potassium intake on~     blood pressure, vascular function and renal function in untreated (pre)hypertensive subjects.~   "
152134|NCT01575028|"~     This study is a prospective, double-blinded, randomized comparison of 2 patient cohorts. One~     group of patients will receive a transversus abdominis plane (TAP) block. The second group~     will receive local anesthetic infiltration injected at the surgical site by the surgeon at~     the end of surgery for a laparoscopic appendectomy. The purpose of this study is to~     prospectively compare post-operative pain relief in pediatric patients undergoing~     laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block~     or local anesthetic infiltration by the surgeon for analgesia to compare the most appropriate~     delivery of effective analgesia. In an effort to improve postoperative analgesia while~     limiting opioid-related adverse effects, there continues to be an increased use of multimodal~     techniques in infants and children.~   "
152135|NCT01575015|"~     Patient with liver failure waiting for liver transplantation are often hospitalized and~     commonly supported in an intensive care unit prior to surgery. These patients are sick, and~     in addition to the complications of a failing liver, other organs such as the kidneys often~     fail as well. As a consequence, these patients are at an increased risk for complications~     related to their kidney failure during their liver transplantation procedure. One potential~     method to diminish the risk of these complications is to provide dialysis support to these~     patients during their liver transplantation in the operating theater in the form of~     continuous renal replacement therapy (CRRT). While this is increasingly being performed and~     is theoretically appealing, there is very little information to support this practice. In~     addition, the use of CRRT during surgery is not entirely without risk. The investigators have~     performed two preliminary studies on the use of CRRT during liver transplantation and our~     data would strongly support the need to conduct further higher-quality studies to better~     evaluate its feasibility, safety and usefulness. Our proposed study is for a randomized trial~     comparing the use of CRRT during surgery with standard supportive care in sick patients with~     liver failure scheduled to receive a liver transplantation.~   "
152136|NCT01575002|"~     In this study the investigators aim to examine the effects of Transcranial Direct Current~     Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing in~     individuals with chronic pain of the cornea -- and also compared with healthy controls.~   "
152137|NCT01574989|"~     In this study the investigators aim to investigate the effects of two different types of~     non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation~     (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This~     is a cross-over study where subjects will receive 5 sessions of stimulation (each separated~     by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham~     tDCS and rTMS.~   "
152138|NCT01574976|"~     The purpose of this study is to determine how feedback and practice affect decision making in~     adolescents with attention deficit and hyperactivity disorder.~      Participants will have to choose between low and certain outcome and a higher but uncertain~     outcome, with or without serial feedback after each trial. Participants will perform the task~     twice to examine practice effects.~   "
152139|NCT01574963|"~     Osteoprotegerin (OPG) is membrane bound in the immune system but can also be produced and~     secreted almost everywhere in the organism, so that it is mainly available in soluble form.~     So far, the OPG/RANKL/RANK system has been most intensively studied in bone. The binding of~     RANKL on its receptor RANK, which is expressed by osteoclasts, activates a number of~     osteoclastic cell functions. OPG also has a key function in the vascular system. Patients~     with coronary heart disease (CAD) have elevated OPG serum levels, probably as a sign of~     ischemic or inflammatory endothelial damage. Elevated OPG levels were also found in patients~     with advanced heart failure, whereby OPG correlated with pro BNP (brain natriuretic peptide)~     and was a predictor for cardiovascular morbidity and mortality.~      Our prospective cohort study will include 150 men (75 patients requiring surgery for CAD and~     a control group without coronary heart disease). The primary endpoints are the differences~     between the two groups in serum levels of OPG and RANKL, markers of bone metabolism~     (osteocalcin [OC], crosslaps [CTX], tartrate resistant acid phosphatase (TRAP5b), 25(OH)~     vitamin D [Vit D], 1.25(OH) vitamin D, parathormone [iPTH], endocrine parameters related to~     vascular damage (e.g. aldosterone, renin and cortisol) and bone mineral density. Metabolomic~     based biomarkers will be evaluated to explore the mechanisms behind OPG-RANKL linked CVD~     damage. In the patients further studies of the mRNA expression of OPG, RANKL, TRAP5b,~     arginine:glycine amidinotransferase (AGAT) and osteocalcin in bone (sternum sliver) and~     vascular wall (aorta, internal thoracic artery and the great saphenous vein) will be~     performed.~      A further study endpoint is the analysis of a causal coincidence between osteoporosis and CAD~     and the discrimination of possible key factors in the two entities. These will be determined~     by the correlation between the above-mentioned markers in serum and the expression in~     different vessels and in bone tissue.~      In addition to analysis of the degree of vascular sclerosis, the mineral content of the bone~     will also be analyzed in a subpopulation with quantitative backscattered electron imaging~     (qBEI) related to the degree of vascular sclerosis and bone mineral density. The ultimate~     goal of the analysis is the discrimination of the most sensitive predictive marker(s) for~     diagnosis and outcome of patients with CAD for the purpose of early diagnosis and primary~     prevention of the disease.~      CAD and osteoporosis are increasingly prevalent diseases that overlap. In both entities, OPG~     plays a role not only in pathogenesis but also as an outcome predictor. We aim to study the~     relevance of OPG concentration in serum but also in the vessel wall and the bone.~   "
152140|NCT01574950|"~     Delirium (confusion) after surgery is common and associated with a longer hospitl stay and~     increased hopsital cost. There is very little information available about how often delirium~     occurs and the complications associated with it. Elderly patients are at high risk for~     delirium after surgery. This research is being done to measure how often delirium after spine~     surgery occurs and to see if there are ways to predict if delirium will develop. The results~     from this study will provide important information on a possible mechanism and predictor of~     delirium.~   "
152141|NCT01574937|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it. It also~     means that the FDA (U.S. Food and Drug Administration) may not have approved this drug for~     use in participants, including people with your type of cancer.~      In this research study, we are testing the safety of XL184 at different dose levels. XL184 is~     a new study drug, which is taken by mouth. Laboratory studies have shown that XL184 may~     prevent tumor growth by stopping the formation of blood vessels inside the tumor and also~     shrink tumors.~      This drug has been used in early-stage studies and is also currently being studied in other~     trials. Information from those other research studies suggests that XL184 may help to slow or~     stop tumor growth including prostate cancer. We will also be taking blood and urine tests to~     look at how your body processes the drug.~   "
152172|NCT01574534|"~     The investigators hypothesize that in a real-world population undergoing percutaneous~     coronary intervention (PCI) for de-novo stenoses in small native vessels with a diameter <3~     mm, drug eluting balloons (DEB) are non inferior to third-generation drug eluting stents~     (DES).~   "
152142|NCT01574924|"~     The Ethics Committee of Hospital and University Center of Coimbra (Portugal) complies,~     reports and is supervisioned by the Portuguese Ethics Committee.~      The Ethics Committee of Hospital and University Center of Coimbra is an multidisciplinary~     organ of Ethics experts that give support to the board of hospital directors, the health~     personnel and patients, regarding bioethical issues emerging from clinical assistance~     activities (addressed to patient's health being, education and clinical research).~   "
152143|NCT01574911|"~     Volumetry is essential for the diagnosis and follow-up of patients with limb edema. The~     objective of this project is the validation of real-time reconstruction and calculation of~     limb volume using a 3D laser scanner.~      Water - displacement volumetry (water-filled boot) is the reference method with known~     accuracy and reproducibility, but is not commonly used in clinical practice because it is~     cumbersome, difficult, and time-consuming. The most commonly used method remains segmental~     limb perimetry with a tape measure, followed by volume calculation using the truncated cones~     formula, thus excluding de facts extremities (hands and feet) which can neither be likened to~     cones nor easily measured.~      Quantification limb volume and volume changes is essential for the diagnosis and follow-up of~     patients with chronic venous insufficiency or lymphedema, two very common pathological~     conditions. It is mandatory for the evaluation of therapeutic approaches.~      The present study will use an innovative technology of volume acquisition by freehand laser~     scanning with a hand-held camera with Quantification limb volume and volume changes is~     essential for the diagnosis and follow-up of patients with chronic venous insufficiency or~     lymphedema, two very common pathological conditions. It is mandatory for the evaluation of~     therapeutic approaches.~      The present study will use an innovative technology of volume acquisition by freehand laser~     scanning with a hand-held camera with real-time 3D reconstruction.~      Its advantages are non-contact, accurate and detailed quantification of edema, including~     extremities, allowing to assess the magnitude and topography of physiological, pathological,~     or treatment - induced volume changes. This approach will ultimately provide data that will~     used for designing personalized limb compression ortheses.~   "
152144|NCT01574898|"~     The purpose of this study is to determine the pharmacokinetic profile of nicotine following a~     single oral administration of three new nicotine lozenge formulations (V0474) in comparison~     with two reference products. The clinical and biological safety of V0474 and the lozenge~     acceptability will also be assessed.~   "
152145|NCT01574885|"~     The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo~     treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at least~     six months.~   "
152146|NCT01574872|"~     The purpose of this study is to evaluate the efficacy of Aerosal® compared to placebo in the~     prognosis of inverse psoriasis or sebopsoriasis present for at least one year~   "
152147|NCT01574859|"~     Retrospective trial of 300 patients with pituitary insufficiency treated in Department of~     Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4)~     replacement and cardiovascular risk factors. The hypothesis is that subtle central~     hypothyroidism is associated with adverse cardiac risk factors, such as body composition and~     serum lipids, and that improved T4 replacement will eliminate this increased risk,~     independently of other pituitary hormone replacements.~   "
152148|NCT01574846|"~     The aim of this non-interventional (observational) study is to document, in collaboration~     with established urologists in Scandinavia, experience gained from routine use of Vantas® for~     the treatment of patients with advanced prostate cancer. In this observational study~     particular attention will be directed to treatment duration, quality of life and patient and~     physician acceptance of the medicinal product for long-term therapy. Patient-based~     measurement parameters such as quality of life and degree of satisfaction will allow~     registration of information that extends beyond the clinical parameters. The knowledge~     gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical~     outcome will also be documented by measuring serum testosterone and prostate specific antigen~     (PSA) levels.~   "
152149|NCT01574833|"~     The investigators hypothesized that early applied pulsed electromagnetic field treatment on~     delayed union might lead to increased rate of fracture union and shortened period of~     treatment.~   "
152150|NCT01574820|"~     Objectives:~      The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial~     for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).~      Background:~      Microvascular and macrovascular complications are common in type 2 DM. There is no evidence~     about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ~     activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory~     process activators) on pre-DM patients with documented CAD.~   "
152151|NCT01574807|"~     The inferior alveolar nerve block (shot) is the most frequently used injection technique for~     achieving local anesthesia (numbness) for the teeth in the lower jaw. However, this injection~     does not always result in successful pulpal (tooth) anesthesia (patient felt pain). No study~     has combined mepivacaine and lidocaine anesthetics (numbing solutions) for this type of~     injection (shot). The investigators propose to compare an injection of mepivacaine followed~     by lidocaine to an injection of lidocaine followed by lidocaine to determine if there is a~     difference in effectiveness.~   "
152152|NCT01574794|"~     The goal of this study is to understand the effects of muscle strengthening and stretching~     exercise intervention on isometric muscle strength, joint flexibility and running~     biomechanical patterns in older recreational runners. To do so, the subjects will be assessed~     before and after they engage in a 8-week exercise intervention program.~   "
152153|NCT01574781|"~     The primary purpose of this study is to collect maternal blood samples from pregnant women to~     develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal~     blood.~   "
152154|NCT01574768|"~     The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment~     of snore and OSAS.~   "
152155|NCT01574755|"~     APC of gastric inlet patches is successful for the treatment of globus sensations in the~     throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term~     efficiency of this treatment. To measure long term efficacy all patients treated with this~     therapy in our clinic were followed up with complaint-evaluation sheets and endoscopy.~   "
182410|NCT01177215|"~     The purpose of this study is to reduce the length of drainage using a treatment protocol to~     control the manipulation of the applied vacuum to the pleural cavity.~   "
152156|NCT01574742|"~     A single center, open label study assessing the feasibility, safety and therapeutic effect of~     Minocycline in adult patients with diagnosis of unipolar depression. Up to 30 patients~     diagnosed with unipolar depression that are in a current depressive episode. The patients~     will be of all racial, ethnic and gender categories, ranging from 18 to 68 years of age, and~     have HDRS-21≥20. All subjects will continue to take their treatment with antidepressant~     medications for the duration of the study. All subjects are prescribed minocycline 200 mg/day~     orally (2X100 mg) for the first 3 days. than, all subjects are prescribed minocycline 400~     mg/day orally (2X200 mg) from day 4 until termination visit (day 35). The primary objective~     of this study is to assess the therapeutic effect of Minocycline in unipolar depression.~      The secondary objectives of this study are to assess the therapeutic effect, the feasibility~     and safety of Minocycline in unipolar depression.~   "
152157|NCT01574729|"~     The primary objectives of this study are to investigate the efficacy and safety of surgery~     combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma~     (NSCLC). The study efficacy endpoints include overall survival, progress-free survival,~     quality of life, and local recurrent rate. The safety endpoint is complications and adverse~     effects.~      The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the~     local recurrent rate.~   "
152158|NCT01574716|"~     This study is being done to see if MORAb-004 increases the effectiveness of the~     chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.~   "
152159|NCT01574703|"~     Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety~     for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total~     of 52 weeks of cardiovascular safety data collection.~   "
152160|NCT01574690|"~     The purpose of this study is to establish the accuracy of a non-invasive device that uses~     near infrared spectroscopy (NIRS) to estimate central venous pressure (CVP) comparing it to~     physical exam and invasive hemodynamic measurement via right heart catheterization (RHC).~   "
152161|NCT01574677|"~     Colorectal cancer (CRC) is the second leading cause of cancer death in the United States and~     affects men and women almost equally. The United States Preventative Services Task Force~     (USPSTF) currently recommends screening with any of three options, which include fecal~     testing, flexible sigmoidoscopy, or colonoscopy.~      Screening for CRC with fecal occult blood testing (using a guaiac-based test) done annually~     or biennially has been shown to decrease mortality 15-33% primarily through detection of~     early stage cancer. Guaiac fecal occult blood testing (gFOBT) has a known positive balance of~     benefit and risk in screening populations, is the least expensive, and is the preferred~     method of screening in 30-55% of patients. The fecal immunochemical test (FIT) offers~     significant improvements over the gFOBT, most notably that it is easier to use (requires~     fewer samples and no dietary or medication restrictions) and is more sensitive than the gFOBT~     with respect to detecting both CRC and precancerous adenomas. As a result of improved test~     performance and usability, in 2008 multiple professional societies endorsed the use of four~     types of FITs for colorectal cancer screening. Kaiser Permanente currently uses the OC-Micro~     FIT as the fecal screening test in all regions.~      In recent years, intensive efforts have been undertaken to identify blood-based markers that~     may provide a promising alternative or supplement to fecal testing for non-invasive CRC~     screening. One method under development is to identify aberrantly methylated genes in cancer~     tissue through a blood test. Prior studies have explored those specific colorectal cancer~     genes that show the highest differences in methylation between the cancer and background~     genetic expression. Of these, methylation of the Septin 9 gene through a qPCR assay is~     relatively well studied.~      The proposed study aims to evaluate whether the Septin 9 biomarker may be used to supplement~     the OC-Micro FIT for colorectal cancer screening in such a way as to safely reduce unneeded~     colonoscopies. The population of interest for this study—those with a positive screening~     OC-Micro fecal immunochemical test—has a CRC prevalence of approximately 5%. Knowing how well~     Septin 9 can identify those without cancer prior to colonoscopy is important largely because~     colonoscopy, even when done diagnostically (e.g., after a positive FIT result), can cause~     serious complications.~   "
152162|NCT01574664|"~     The goal of this investigation is to obtain clinical data to show the Health Beacons~     Radiofrequency Identification (RFID) Localization System is safe and performs as intended as~     a localization device for marking and retrieving a non-palpable surgical target from the~     breast.~   "
152163|NCT01574651|"~     This study will assess the efficacy and safety of QVA149 compared to tiotropium plus~     formoterol in patients with moderate to severe COPD.~   "
152164|NCT01574638|"~     This study will evaluate two different ways to give rifapentine (RPT), a drug that may help~     shorten treatment duration for tuberculosis (TB) disease.~   "
152165|NCT01574625|"~     A Single Center Non-Interventional Post-Market Release, Long Term Follow Up study of patients~     who underwent Isolated Aortic Valve Replacement or Isolated Mitral Valve Replacement with a~     Medtronic Mosaic Bioprosthesis. The purpose of this study is to evaluate the long term~     safety, efficacy and clinical performance of the Mosaic Bioprostheses.~   "
152166|NCT01574612|"~     To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of~     recurrent cold sores in children ages 6-11yrs after 5 days of treatment.~   "
152167|NCT01574599|"~     The purpose of this study is to assess whether a novel therapy approach (repetitive~     facilitative exercise (RFE)) is more effective than conventional rehabilitation in~     facilitating the recovery of upper extremity function following stroke.~   "
152168|NCT01574586|"~     The primary objective of this study is to make a comparison of safety and efficacy of DESs~     with different link number (2-link Nobori and 3-link Xience) in patients with de novo true~     bifurcation lesions.~      The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE~     rate until one year after PCI will be assessed in both groups.~   "
152169|NCT01574573|"~     By affecting the gastroesophageal pressure gradient, obesity predisposes to reflux of gastric~     contents. The investigators hypothesized that the loss of weight will decrease this gradient~     and as a result decrease the severity and frequency of GERD symptoms. GERD negatively affects~     health related quality of life. Since loss of weight may decrease gastroesophageal reflux,~     the investigators hypothesized that it obesity contributes to poor quality of life in GERD~     subjects and losing weight should also favorably impact and improve quality of life in GERD~     patients.~   "
152170|NCT01574560|"~     Smoking is widely accepted to cause an increase in an individual's likelihood of developing~     cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand~     smoke inhaled by a non-smoker has also been associated with the development of several~     illnesses. This study focuses on learning how to make your home smoke-free.~   "
152171|NCT01574547|"~     This study was designed to: estimate the incidence of cat scratch colon in the investigators~     environment; explore the diseases associated to its development; identify the factors related~     to its development; and assess its clinical repercussions.~   "
182411|NCT01177202|"~     The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1~     Vaccine In Healthy Adults~   "
152173|NCT01574521|"~     Animal experiments demonstrated that father might transmit HBV vertically via male germ line,~     however, whether it is really existed in human remains to be determined. Since HBV is a~     blood-borne virus, the unvaccinated pregnant women would be at risk for HBV exposure if their~     fetuses carried the virus from fathers. If women had been vaccinated for HBV before~     conception, what would happen to a maternal immune system if her fetus carried HBV from~     spermatozoa? However, the literature on transmission of HBV by spermatozoa in vivo is rare,~     the viral replicating status and fetal immune response in uterus are unknown. The aim of~     study was to detect father-to-fetus transmission of hepatitis B virus (HBV) in uterus.~   "
152174|NCT01574508|"~     The current study will compare the different efficacy of two transient intensive insulin~     treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily~     insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic~     agents.~   "
152175|NCT01574495|"~     This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that~     leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer~     singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus~     forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art system~     which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's~     desired trajectory can be determined and the movement errors can be amplified in real-time~     with dramatic results. This project evaluates a practical approach of error augmentation,~     using therapist-driven trajectories. The investigators intend to determine clinical efficacy~     of several types of therapist-assisted error augmentation on retraining the nervous system in~     functional activities. The investigators will test two experimental treatments in a crossover~     design. The investigators hypothesize that combined haptic and visual error augmentation will~     lead to the best functional recovery.~   "
152176|NCT01574482|"~     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable~     low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in~     mildly hypercholesterolemic people treated or not by statins~   "
152177|NCT01574469|"~     The purpose of this study is to investigate the effect on cholesterolemia profile of a low~     fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in~     mildly hypercholesterolemic people treated or not by statins.~   "
152178|NCT01574456|"~     The main aim of the present study is to improve our understanding of the role of blood-brain~     barrier function in dementia of the Alzheimer's type. The investigators hypothesize that~     microvascular dysfunction - more specifically cerebral perfusion and blood-brain barrier~     leakage - is a determinant of cognitive decline and cortical atrophy in Alzheimer's disease.~   "
152179|NCT01574443|"~     The principle aim of this project is to characterize the changes in relative stability of the~     intrinsic brain dynamics during onset of sleep and induction of general anesthesia. The~     investigators hypothesize that brain dynamics in the awake state are critical akin to~     physical systems close to a second order phase transition and that during loss of~     consciousness the dynamics move away from the critical point.~   "
152180|NCT01574430|"~     The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin~     dose in the treatment of CSC.~   "
152181|NCT01574417|"~     Plant sterols and stanols are dietary components that are naturally present in plants. Their~     biological function in plants is comparable with these of cholesterol in animals. They are~     structurally related to cholesterol, but are absorbed by enterocytes to a much lesser extent.~     It is generally accepted that they inhibit intestinal cholesterol absorption and consequently~     lower serum low-density lipoprotein (LDL) cholesterol concentrations up to 10% at daily~     intakes of 2.5 g. The exact underlying mechanism of the plant sterol/stanol mediated~     reduction in intestinal cholesterol absorption is still unknown. It has been suggested that~     they lower the activity of sterol uptake transporters like Niemann-Pick C1 like 1 protein~     (NPC1L1) in enterocytes, otherwise several studies indicated that these compounds could~     activate the liver X receptor (LXR) in enterocytes, thereby activating the ABC transporters~     involved in the intestinal cholesterol metabolism, whereas recently suggestions have been~     made that plant sterols and stanols activate transintestinal cholesterol excretion (TICE).~     This is the direct cholesterol secretion from the blood into the intestinal lumen, in which~     the enterocytes play a central role. None of these assumptions have so far been evaluated in~     humans.~      Objective: The major objective of the present study is to examine the acute effects of~     dietary plant stanol esters on the intestinal mucosal gene expression profiles in intestinal~     biopsies in healthy volunteers. The minor objective is to investigate whether semi-long-term~     use (3 weeks) of plant stanol esters have an effect on microbiota composition.~   "
152182|NCT01574404|"~     People with infertility undergoing in vitro fertilization (IVF) can test the embryos using a~     method called preimplantation genetic screening (PGS) before they are implanted in the uterus~     to possibly increase their chances of having a successful pregnancy. One or more cells are~     removed from the embryo. The chromosomes inside the cells are then tested to identify normal~     or aneuploid embryo(s).~      The investigators propose to evaluate a test called micro array analysis on the chromosomes~     of the first polar body. This method tests part of the egg that would normally be lost and~     may help us choose the embryo most likely to become a healthy baby.~   "
152183|NCT01574391|"~     The purpose of this study is to determine whether the use of the Epidrum device to identify~     the epidural space in labouring parturients reduces morbidity, when compared to standard loss~     of resistance techniques.~   "
152184|NCT01574378|"~     VLock suture studied in abdominal wound closure. Time and cosmesis was studied~   "
152185|NCT01574365|"~     A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes~     mellitus.~   "
152208|NCT01574066|"~     Primary objective : to estimate impact of CT-scan on diagnostic for emergency department (ED)~     patients with suspected Community-acquired Pneumonia (CAP).~      Secondary objective: to estimate impact of CT-scan on treatment (antimicrobial therapy) and~     site of care for ED patients with suspected CAP.~   "
152291|NCT01572974|"~     To Compare the overall quality of life of patients with no Barrett's esophagus ,~     non-dysplastic Barrett's Esophagus (NDBE), Barrett's esophagus with low grade dysplasia~     (LGD), and Barrett's esophagus with high grade dysplasia (HGD). We also Compare the overall~     quality of life of Barrett's esophagus patients with severe gastroesophageal reflux disease~     (GERD) symptoms to those with no GERD symptoms~   "
152186|NCT01574352|"~     Strong and consistent evidence have shown that overweight, including obesity, is an important~     risk factor for the development of cardiovascular disease (CVD) in adults. Several studies~     have found an association between overweight in childhood and increased risk of morbidity and~     mortality later in life. The prevalence of overweight in children and adolescents has~     increased in recent years, and consequently it is important to identify effective approaches~     in the prevention and treatment of overweight in young individuals.~      Approaches such as resident weight loss camps have shown promising results. A residential~     camp setting provides an opportunity to increase and control exposure to, for instance,~     particular foodstuffs, beverages and physical activity opportunities. However, well-designed~     studies with sufficient participants are still needed on the reversal of overweight in~     childhood with increased focus on documenting predictors of behavior changes associated with~     decreases in overweight.~      This study is carried through as a randomized controlled trial which investigates the effect~     of participating in a 6 week health promoting resident for overweight fifth grade children~     camp followed by 42 weeks of family support.~      The study hypothesis is that participating in a 6 week resident camp and a following period~     of 42 weeks of child and family support will induce a reduction in body mass index (BMI). In~     addition it is expected that the intensity and duration intervention program is sufficient to~     cause changes in physiological parameters related to a reduced risk of lifestyle diseases.~   "
152187|NCT01574339|"~     The EndoStim LES Stimulation System is an investigational device intended to improve the LES~     pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from~     Gastroesophageal Reflux Disease (GERD).~   "
152188|NCT01574326|"~     Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to~        -  Evaluate the safety and tolerability of sevelamer carbonate~        -  Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus~   "
152189|NCT01574313|"~     Stellate ganglion block (SGB) has been the alternative treatment of Meniere's disease for~     years. However, objective evidence of the effect of SGB was still lack. The investigators~     conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of~     electrocochleography (ECoG).~   "
152190|NCT01574300|"~     The purpose of this study is to facilitate application of the known biomarkers to patients~     presenting today, and to establish a collection of biospecimens that will be useful for~     discovering and validating new biomarkers for future use.~   "
152191|NCT01574287|"~     Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a~     small growth called an adenoma in the parathyroid glands) is an increasingly significant~     medical and public health condition.~      Surgery is the only effective management for primary hyperparathyroidism. However; it is~     sometimes difficult to pinpoint the adenoma, in part because current methods of imaging often~     fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative~     parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an even~     greater role. Unfortunately current multiple imaging methods fail to localize 10-15% these of~     tumors.~      SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing~     the tumor. This, however, is a challenge because the parathyroid glands usually are located~     close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and~     parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the~     parathyroid but not in the thyroid.~      A more sensitive and specific radiotracer/tracking agent would markedly improve the~     investigators ability to identify parathyroid tumors preoperatively, and thus offer more~     patients a minimally invasive parathyroidectomy.~      anti-3-[18F]FACBC is an amino acid based PET radiotracer which has shown utility in detecting~     a variety of tumors. In cell culture experiments, anti-3-[18F]FACBC has shown uptake in~     parathyroid cells greater than thyroid cells. Therefore, the investigators think that this~     radiotracer may be able to help us identify parathyroid adenomas better than 99mTc sestamibi.~      The primary aim of this study is to determine if anti-3-[18F]FACBC PET-CT demonstrates uptake~     within parathyroid adenomas. 12 patients with a diagnosis of primary hyperparathyroidism will~     undergo PET-CT using anti-3-[18F]FACBC in addition to the standard 99mTc sestamibi scanning~     and other imaging as clinically appropriate such as ultrasound, MRI, and/or contrast enhanced~     CT scanning. Since all these patients undergo surgery routinely, the investigators will then~     compare findings at surgery to those of the anti-3-[18F]FACBC PET-CT to determine if this~     radiotracer is worthy of further study in a more comprehensive experiment.~   "
152192|NCT01574274|"~     This study is being conducted to learn about the effects of SC-PEG, which is a new form of a~     chemotherapy drug called asparaginase. Asparaginase is used to treat ALL and lymphoblastic~     lymphoma. The standard form of asparaginase, called Elspar, is given in the muscle once a~     week for 30 weeks. There are other forms of asparaginase. The investigators will be studying~     two of these: Oncaspar and Calaspargase Pegol (SC-PEG). The investigators have previously~     studied giving Oncaspar in the vein (instead of the muscle) every 2 weeks in patients with~     ALL, and have shown that this dosing did not lead to any more side effects than Elspar given~     weekly in the muscle. The study drug, SC-PEG, is very similar but not identical to Oncaspar.~     SC-PEG has been given in the vein to children and adolescents with ALL as part of other~     research studies, and it appears to last longer in the blood after a dose than Oncaspar. It~     has not yet been approved by the FDA. The goal of this research study is to learn whether the~     side effects and drug levels of SC-PEG given in the vein every 3 weeks are similar to~     Oncaspar given into the vein about every 2 weeks.~      The study will also help to determine whether changing treatment for children and adolescents~     with ALL with high levels of minimal residual disease may improve cure rates. Measuring~     minimal disease (MRD) is a laboratory test that finds low levels of leukemia cells that the~     investigators cannot see under the microscope. In the past, it has been shown that children~     and adolescents with ALL with high levels of MRD after one month of treatment are less likely~     to be cured than those with low levels of MRD. Therefore, on the study, the bone marrow and~     blood at the end of the first month of treatment will be measured in participants with~     leukemia, and changes in therapy will be implemented based on this measurement. It is not~     known for sure that changing treatment will improve cure rates. MRD levels can only be~     measured if the marrow is filled with cancer cells at the time of diagnosis. Therefore, MRD~     studies will only be done in children and adolescents with ALL and not in those with~     lymphoblastic lymphoma.~      Another part of the study is to determine whether giving antibiotics during the first month~     of treatment even to participants without fever will prevent serious infections in the blood~     and other parts of the body. About 25% of children and adolescents with ALL and lymphoblastic~     lymphoma who receive standard treatment develop a serious blood infection from a bacteria~     during the first month of treatment. Typically, antibiotics (medicines that fight bacteria)~     are given by vein only after a child with leukemia or lymphoma develops a fever or have other~     signs of infection. In this study, antibiotics will be given by mouth or in the vein to all~     participants during the first month of treatment, whether or not they develop fever.~      Another goal of the study to learn how vitamin D levels relate to bone problems (such as~     broken bones or fractures) that children and adolescents with ALL and lymphoblastic lymphoma~     experience while on treatment. Some of the chemotherapy drugs used to treat ALL and~     lymphoblastic lymphoma can make bones weaker, which make fractures more likely. Vitamin D is~     a natural substance from food and sunlight that can help keep bones strong. The investigators~     will study how often participants have low levels of vitamin D while receiving chemotherapy,~     and, for those with low levels, whether giving vitamin D supplements will increase those~     levels.~      Another focus of the study is to learn more about the biology of ALL and lymphoblastic~     lymphoma by doing research on blood, bone and spinal fluid bone marrow samples. The goal of~     this research is to improve treatment for children with leukemia in the future.~   "
152193|NCT01574261|"~     Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk. The aim~     of the study was to evaluate long-term effects of inositol on some cardiovascular risk~     factors in PCOS patients.~   "
152194|NCT01574248|"~     Individuals with heart disease or high blood pressure are often prescribed angiotensin~     converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors~     can be associated with angioedema, a rare but life-threatening condition that causes swelling~     of the face and other body parts. This study will evaluate the effectiveness of the drug~     HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the~     condition.~   "
152195|NCT01574235|"~     The main aim of the study is to assess the safety of Nivestim® treatment in patients treated~     with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant~     hemopathy.~   "
152196|NCT01574222|"~     The purpose of this study is to determine the dose that the vaccine can be given safely to~     patients when injected directly into the lung tumor, without any serious side effects.~   "
152197|NCT01574209|"~     It is well known that the intestinal barrier is altered in celiac disease (CD), an autoimmune~     disease that develops in genetically predisposed subjects exposed to ingestion of wheat~     gliadin and of related prolamines of barley and rye. More recently, defective epithelial~     barrier has been implicated in the pathogenesis of other conditions such as irritable bowel~     syndrome (IBS). At present IBS is still considered a functional condition although low-grade~     inflammation has been associated with its manifestation, particularly that following~     infection. Different substances have been implicated in the (dis)regulation of intestinal~     barrier, among them zonulin seems to play a key role. Other gastrointestinal peptides are~     GPL-2, Ghrelin, and Epidermal growth factor (EGF). In order to shed light on the hormonal~     regulation of intestinal barrier function in celiac patients before undergoing a gluten free~     diet and possible differences with those of IBS patients, in the present study the~     investigators will apply the non-invasive lactulose/mannitol permeability test toward the~     evaluation of intestinal damage. The pattern of intestinal permeability and the GI peptides~     concentration will be compared in celiac patients, IBS patients and healthy controls.~   "
152198|NCT01574196|"~     The SALTO-SNA study is an ancillary study of the SALTO study (Suivi À Long Terme en Oncologie~     des enfants guéris d'un cancer pédiatrique en régions Rhône-Alpes et Auvergne) coordinated by~     Dr. Claire Berger, pediatric oncologist at the CHU, Saint Etienne. It aims at re-examining,~     in their initial treatment center, all patients (a cohort of 495 patients alive in 2011),~     diagnosed between 1987 and 1992, and cured of childhood cancer (except leukemia) in the~     Rhône-Alpes and Auvergne regions.~      The rationale for this study is based on the observation that although the survival rate of~     childhood cancers has now reached 75%, complications of chemotherapy and radiotherapy are~     high and greatly increase the risk of mortality in later years (estimated to be 14% in the~     literature).~      The morbidity risk of chemotherapy and radiotherapy can be quantified by assessing the~     activity of the intrinsic cardiac autonomic regulation, which represents a powerful predictor~     of cardiovascular morbidity to the individual.~   "
152199|NCT01574183|"~     Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated~     pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of~     vilazodone for reducing marijuana use in marijuana-dependent adults. A contingency management~     intervention (CM)and motivational enhancement therapy (MET)will be incorporated to encourage~     study engagement and retention, and genomic DNA will be extracted to characterize subjects~     according to polymorphisms of genes potentially relevant to the activity of vilazodone. It is~     hypothesized that vilazodone combined with MET and CM will reduce the percent of~     marijuana-positive urine drug screen results in marijuana-dependent individuals as compared~     to a placebo treatment combined with MET and CM.~   "
152200|NCT01574170|"~     This is a biomedical study of interventional type. The trial will include 270 patients (180~     patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2~     years of follow up.~      This prospective study will be conduct in patients who will receive a third line chemotherapy~     for metastatic breast cancer.~      The main objective of the study (first cohort) is to identify patients who benefit from a~     third line treatment in terms of overall survival with a score established from clinical,~     histological, but also biological classic and innovative (account of circulating tumor~     cells) criteria, all of these criteria must be measurable before the introduction of the 3rd~     line.~      This score will then be validated on the 2nd cohort.~      There will be no interruption of inclusions between first and second cohort of patients~   "
152201|NCT01574157|"~     The purpose of this study is to see if treatment with sodium bicarbonate will lower urine~     levels of proteins that are indicators of kidney damage in people with diabetes who also have~     chronic kidney disease.~   "
152202|NCT01574144|"~     The purpose of this observational study is to collect and characterize multiple physiologic~     data from a broad subset of subjects with acute heart failure (HF)~      Changes in physiologic data are expected to correlate with 30-day readmission rates in this~     population~   "
152203|NCT01574131|"~     The purpose of this study is to learn the following: whether long-term treatment (6 months)~     with fenofibrate will decrease burn related sugar and fat increased in the blood and help~     prevent muscle loss and improve wound healing.~   "
152204|NCT01574118|"~     This study is investigating a new brief psychotherapy for post-traumatic stress disorder~     (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components~     and modifying several others. The goal of the study is to determine whether this experimental~     treatment outperforms the well-established standard treatment.~   "
152205|NCT01574105|"~     Blood is anticoagulated using a drug named heparin during open-heart surgery to allow it to~     safely pass through the heart-lung machine which pumps the blood throughout the body during~     the surgery. Each patient is given the heparin they need for their surgery. This means some~     patients receive more or less heparin than other patients. In this study, the investigators~     will be evaluating the current anticoagulation protocol for open heart surgery in use at the~     Royal University Hospital. The goal of this project is to compare patients who require and~     receive more heparin for proper anticoagulation to those patients who require and receive~     less heparin.~      Open-heart surgery will proceed according to the standard hospital protocol. All research~     participants will be treated according to standard post-open heart surgery protocol in the~     ICU. This will include measurement of blood loss by keeping track of chest tube outputs and~     administration of blood transfusions.~      This study focuses on Saskatoon Health Region patients having open heart surgery in terms of~     the protocol for anticoagulation and blood transfusions.~   "
152206|NCT01574092|"~     Tumours of the brain and of the central nervous system (CNS) are the most common solid~     tumours in children. Amongst these, gliomas are the most frequent, although this term covers~     different histological subtypes, the most frequent being astrocytoma. However, they are rare~     diseases of low prevalence.~      The interest in the cisplatin/irinotecan combination in brain tumours motivated a previous~     pilot study at our hospital, with encouraging results. This experience, together with the~     need for new strategies for high-risk pediatric gliomas has motivated the conduct of this~     study.~   "
152207|NCT01574079|"~     Mirror therapy may be an effective intervention in increasing motor control and gait~     performance in patients with stroke.~   "
156821|NCT01513460|"~     This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium~     when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary~     disease.~   "
152209|NCT01574053|"~     Enroll-HD is a longitudinal, observational, multinational study that will integrate two~     existing Huntington's Disease (HD) registries, REGISTRY in Europe and COHORT in North America~     and Australia, while also expanding to include sites in Latin America and Asia. With no end~     date and annual assessments, the goal of Enroll-HD is to build a large and rich database of~     longitudinal clinical information and biospecimens. This database will serve as a basis for~     future studies aimed at developing tools and biomarkers for progression and prognosis,~     identifying clinically relevant phenotypic characteristics, and establishing clearly defined~     endpoints for interventional studies.~   "
152210|NCT01574040|"~     Rationale: Lifestyle modifications, such as increasing physical exercise and reducing dietary~     salt and saturated fat intake contribute to prevention of cardiovascular morbidity and~     mortality. Relevant improvements can already be achieved by small adaptations in everyday~     life. It is unclear whether simple low-cost interventions in the working environment can~     promote such healthy lifestyle adaptations.~      Objective: To study the effect of low-cost interventions for promoting healthy lifestyle~     modifications.~      Study design: Before-and-after intervention study. The study period will be subdivided in~     four parts of 2 weeks each: a run-in period, a before-measurement period, an~     intervention-period, and an after measurement period.~      Study population: Staff and visitors of the University Medical Center Utrecht.~      Study interventions:~        -  Promotion of stair climbing.~        -  Promotion of a low-salt soup alternative for the 'soup of the day'.~        -  Promotion of a low-fat alternative for the butter croissants.~        -  Exchange of the basket positions of butter and margarine between convenient and harder~          to reach locations.~      Outcome measures:~        -  Number of passages through each part of the stair cases.~        -  Number of low-salt cream soup and normal clear soup cups sold in the hospital restaurant~          and ratio between them.~        -  Number of low-fat and normal croissants sold in the hospital restaurant and the ratio~          between them.~        -  Number of low-fat margarine servings and butter servings sold in the hospital restaurant~          and the ratio between them.~   "
152211|NCT01574027|"~     Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30~     years, but has never been directly studied in humans. The biologically active version of~     vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause~     serum calcium levels to rise. In contrast, 25(OH)D3 (ie calcifediol) does not have this side~     effect. The investigators previous research suggests that the enzyme necessary to convert~     25(OH)D3 (calcifediol) into active 1,25(OH)D3 is present in cells lining the large intestine~     (colon).~      Aberrant crypt foci (ACF) are very small (ie microscopic) collections of abnormally shaped~     cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely~     uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not~     fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC~     decreases.~      The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or~     placebo, and determining if there is a drug-dependant decrease in ACF number. The primary~     objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to~     placebo, causes significant reduction of ACF number from baseline levels. The primary~     endpoint will be change in ACF number.~   "
152212|NCT01574014|"~     Social phobia is the third most common psychiatric disorder besides depression and~     alcoholism. Several studies have demonstrated the efficacy of cognitive-behavioral therapy in~     the treatment of social phobia. Nevertheless, there is no effect in a third of the people at~     the existing treatment methods. Pharmacological therapies have similar effects, but there is~     a high rate of relapse after discontinuation of medication.~      Social phobia is characterized by fear of performance or interaction situations. The strong~     fear of negative evaluation by others is usually accompanied by a marked avoidance behavior~     and increased physical symptoms such as blushing, sweating, palpitations, or tremors. The~     confrontation with a phobic stimulus leads to a retrieval of stimulus-associated aversive~     memories, resulting in an immediate anxiety response. Several studies had already shown that~     elevated glucocorticoids impair retrieval of declarative memory contents in healthy subjects.~     The investigators demonstrated an anxiety-reducing effect after the administration of~     cortisone before the confrontation with a phobic stimulus in patients with social and spider~     phobia.~   "
152213|NCT01574001|"~     The primary objective of the present randomized controlled trial is to compare the~     effectiveness of three anti-smoking interventions of different intensities. It has been~     hypothesised that early follow-up visits facilitate post-stroke smoking cessation in patients~     hospitalized because of first-ever ischemic stroke.~   "
152214|NCT01573988|"~     In this study, the investigators are interested in assessing the effects of the isocaloric~     increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric~     breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese~     subjects through :~        -  the physiological consequences : difference in postprandial kinetics of glucose, non~          esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin,~          ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1~          (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA),~          glutathion, lipid hydroperoxides)~        -  eating behavior during an ad libitum buffet test meal~   "
152215|NCT01573975|"~     The purpose of this study is to compare the eradication efficacy of 10-day triple therapy~     with 10-day sequential therapy with tetracycline or metronidazole.~   "
152216|NCT01573962|"~     The objective of this sample collection study is to collect blood and urine samples. This~     study is observational and will have no impact on the medical management of the subject.~   "
152217|NCT01573949|"~     The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will~     assess the use of the medication metformin to improve quality of life, exercise capacity, and~     improved outcomes in heart failure patients with pre-DM or early DM (type II).~      If the patient participates in this study, the patient will receive the drug metformin for~     approximately 3 months. During the study the patient will undergo comprehensive testing which~     includes blood draws and echocardiograms. The patient will also fill out a questionnaire. The~     patient must be 18 years old to participate.~   "
152369|NCT01571960|"~     This study will test the safety and immune responses of a prime-boost regimen of two HIV~     vaccines— a DNA vaccine followed by a modified vaccinia Ankara (MVA) vaccine— in healthy,~     HIV-uninfected, vaccinia-naive adults.~   "
152218|NCT01573936|"~     The purposes of this study were to evaluate the influence of an interdisciplinary~     rehabilitation program in the improvement of the health-related quality of life among adult~     neurological patients and to identify the sociodemographic and clinical associated~     characteristics. Subjects with spinal cord injury, acquired brain injury and poliomyelitis~     survivors participated in the study. All participants underwent a rehabilitation program (RP)~     from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2~     days a week. The WHOQOL-BREF was applied at the initial and discharge assessments.~   "
152219|NCT01573923|"~     Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality~     worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel~     therapies are necessary to prevent or block the process of the disease. In this current~     prospective cohort, the investigators plan to organize four hospitals to determine the safety~     and efficacy of intravenous administration of umbilical mesenchymal stem cells in the~     treatment of patients with liver cirrhosis in next three years.~   "
152220|NCT01573910|"~     The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the~     treatment of bacterial conjunctivitis in Chinese patients.~   "
152221|NCT01573897|"~     Sleep apnea syndrome (SAS) is a common comorbidity of type 1 and type 2 diabetes. A low~     transcutaneous oxygen tension (PtcO2) measured on the foot is pejorative prognostic factor~     for the healing of a diabetic foot wound. SAS causes intermittent nocturnal hypoxia and~     sympathetic overactivity. The investigators hypothesized that SAS could be a factor reducing~     the PtcO2.Therefore, the main objective of this study is to assess the variation in PtcO2~     between the end of the night and midday in patients with -or at risk of- diabetic foot wound~     according to the presence or not of sleep apnea syndrome.The secondary objective is to~     address the microvascularisation of diabetic patients having foot wounds according to their~     status regarding sleep apnea syndrome.~   "
152222|NCT01573884|"~     -  Exploratory analyses of the immune response in a ex vivo culture system~        -  Characterization of the composition of maternal milk and infant urine~   "
152223|NCT01573871|"~     The objective of the study is to assess gastrointestinal tolerance and compliance in infants~     who require a hydrolyzed formula.~   "
152224|NCT01573858|"~     The objectives of the present trial are to test the following three hypotheses in anovulatory~     women with PCOS:~        1. Acupuncture protocol 1 plus CC (Arm A) is more likely to result in live birth than~          acupuncture protocol 2 combined with CC (Arm B),~        2. Acupuncture protocol 2 plus CC (Arm B) is more likely to result in live birth than~          acupuncture protocol 1 plus placebo (Arm C),~        3. Acupuncture protocol 1 plus placebo (Arm C) is more likely to result in live birth than~          acupuncture protocol 2 plus placebo (Arm D).~   "
152225|NCT01573845|"~     The central hypothesis of The GREEN Project Lunch Box Study is that a school-based~     communication campaign that combines healthy eating and eco-friendly messages will improve~     the quality of foods that children bring from home to school more than a healthy eating~     campaign alone and compared to a control/delayed intervention condition at the end of one~     school year.~   "
152226|NCT01573832|"~     This study will use a randomized control trial design to compare wound care clients who~     receive integrated care versus usual care in Community Care Access Centres (CCAC) in~     Ontario. Data will be collected by existing administrative databases and linked by the~     Institute for Clinical Evaluative Sciences (ICES). The researchers will analyze these~     databases and report findings.~   "
152227|NCT01573819|"~     The study drug, GSK356278, is a possible new medicine for the treatment of Huntington's~     disease. Huntington's disease, which is often called HD, is caused by a faulty gene that is~     passed down through families. HD causes damage to nerve cells in the brain which causes them~     to waste away. As the damage progresses patients develop symptoms that affect every aspect of~     life. HD reduces people's ability to walk, talk, think, communicate and causes uncontrolled~     movements. GSK356278 may slow down the progression of damage to nerve cells in people with HD~     and help with their ability to think.~      GSK356278 was well tolerated when it was given as a single dose to healthy people. In this~     study we want to see what effects, both good and bad, GSK356278 has in people when it is~     taken every day. During the study we will look at about 3 different doses of GSK356278 in~     about 36 healthy people. The study will also look at how GSK356278 tablets behave in the body~     after it is swallowed (this is called pharmacokinetics). The study will also look at effects~     of GSK356278 on the body (this is called pharmacodynamics). The study will help to design~     future clinical studies with GSK356278.~   "
152228|NCT01573806|"~     Pharmacology of Exenatide in Pediatric Sepsis, PEPS is a phase 1-2 research study that will~     examine drug safety, drug metabolism, drug action and preliminary drug clinical effects of~     four does of exenatide injected every 12 hours to children with shock from infection (septic~     shock). The investigators hypothesize that exenatide can be safely dosed to children with~     sepsis to achieve blood levels of drug similar to that achieved in teenagers with type 2~     diabetes. The investigators further hypothesize that injection of exenatide to children with~     septic shock will normalize blood glucose levels and decrease levels of inflammation proteins~     in the blood during the early course of sepsis.~   "
152229|NCT01573793|"~     The purpose of this study is to determine if providing parenting education materials~     delivered in different ways during the first 30 months of a child's life will increase~     child-parent attachment and promote mother-child interaction, if certain types of strategies~     improve cognitive, language, and emotional development in infants and toddlers, and if our~     way of delivering these materials is cost-effective.~   "
152230|NCT01573780|"~     The purpose of this study is to determine the dose of smac mimetic TL32711 that is safe and~     tolerated when given with gemcitabine hydrochloride to patients with advanced cancer~   "
152280|NCT01573117|"~     Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac~     arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling~     associated cerebrovascular disease. The narrow-time-frame is a major issue (time is brain).~     To provide immediate cooling without delay, easy to use, mobile and effective methods are~     needed. Cold infusions (4 °C) are an accepted standard worldwide. The RhinoChill (BeneChill,~     USA) is a new device. A comparison of these two induction methods has never been done before.~     Neither was the effect of cold infusions on brain-temperature measured. For the first time~     iCOOL 1 compares feasibility, safety and efficacy of the two methods.~   "
152231|NCT01573767|"~     This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group,~     placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma.~     Subjects entering the run-in period will stop their current asthma medication and be given~     open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and~     salbutamol/albuterol as required to use throughout the run-in and double-blind treatment~     period. At Visit 3 subjects meeting the randomization eligibility criteria will receive~     vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI)~     once daily for 4 weeks in addition to open-label fluticasone propionate twice daily~     throughout the treatment period. Primary endpoints consist of change from baseline in clinic~     visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period~     in all subjects. Safety assessments include adverse events, oropharyngeal examinations,~     clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all~     subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at~     specific time intervals relative to the dose of study drug.~   "
152232|NCT01573754|"~     Porphyria cutanea tarda (PCT) is an iron-related disorder that responds to treatment by~     phlebotomy or low-dose hydroxychloroquine, but comparative data on these treatments are~     limited. The hypothesis is that hydroxychloroquine is noninferior to phlebotomy in terms of~     time to remission. Patients with well documented PCT are assigned to treatment by~     randomization if specific criteria are met. All patients are followed until remission -~     defined as achieving a normal plasma porphyrin concentration.~   "
152233|NCT01573741|"~     Primary Outcome Measures:~      Evaluate the changes in neuroimaging and biochemistry measures with ketamine treatment.~      Secondary Outcome Measures:~      Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in~     psychiatric symptoms, and suicidal ideation.~   "
152234|NCT01573728|"~     The pilot project proposed here will establish the feasibility and preliminary data necessary~     to test in a subsequent randomized trial: 1) whether independent of social contact, aerobic~     exercise training is effective in the treatment of depression and 2) whether changes in~     biological markers indicate an anti-inflammatory process, neurogenesis process, or both as a~     result of exercise. Target participants are adults aged 46 years or over who have current~     minor to moderate depressive symptoms.~      This pilot is a three-arm design of low dose exercise versus public health dose exercise~     intended to: 1) establish the feasibility, acceptance, and safety of Internet-based~     supervised exercise training and 2) obtain retention and attendance estimates needed to~     determine sample sizes for the follow-up trial.~   "
152235|NCT01573715|"~     Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical~     ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a~     prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular~     blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al.~     ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve~     survival remain speculative. They are as follows:~        -  reduction of the consumption of oxygen linked to ventilatory workload;~        -  increase of chest wall compliance improving mechanical ventilation during ARDS and~          better adaptation to the protective ventilation strategy;~        -  anti-inﬂammatory effect contributing to a reduction in pulmonary inﬂammation and~          improvement in oxygenation,~        -  reduction of the variations of transpulmonary pressure (TPP) by the way of better~          synchronisation between patient and the ventilator.~      The use of NMBA could also reduce the ventilator induced lung injury by a better control of~     TPP.~   "
152236|NCT01573702|"~     - Progression free survival after locally ablative therapy and erlotinib in EGFR patients~     progressed after EGFR-TKI therapy~   "
152237|NCT01573689|"~     The methodology of this clinical trial is based on the realisation of a group intervention~     with children who lost a parent. Interviews preintervention and postintervention with~     participants will be done as well. The purpose of this study is to answer the following~     question: What are the benefits for children who are in the process of bereaving a parent to~     participate in a group work intervention based on the mutual aid model ?. The aim of the~     research is to explore the benefits for grieving children to participate in an group work~     intervention based on the mutual aid model. To do so, the research has three distinct~     objectives : 1) to develop and apply a program of group work interventions for grieving~     children based on the mutual aid model ; 2) to explore the extent to which participation in~     the group facilitates changes in the children's discourse about death and the loss of their~     parents, and 3) to examine, from the children's own perceptive, the possible impact that~     their participation in the group have on their experience of bereavement.~   "
152238|NCT01573676|"~     Obesity is a very important risk-factor in obstructive sleep apnea (OSA) and other sleep~     breathing disorders in patients with extreme BMI.~      Candidates for bariatric surgery have a high OSA prevalence, ranging from 60-83%. The~     characteristics of patients with sleep apnea that were evaluated for bariatric surgery and~     had a full overnight polysomnography (PSG) screening for OSA were described and it was found~     that a very high prevalence (77.2%) for OSA in all subjects evaluated, regardless of~     pre-operative risk for OSA. A post-bariatric surgery PSG was not a part of this study.~      The investigators would like to demonstrate the impact of bariatric surgery on OSA as a~     function of time.~   "
152239|NCT01573663|"~     The purpose of this study is to evaluate the drug-durg interaction between ambroxol and~     levodropropizine.~   "
152240|NCT01573650|"~     1. To analyse the outcome of different treatment options of peripheral nerve repair with no~          gap (group 1) and with a critical sized (>5mm) defect (group 2) in order to optimize~          peripheral nerve repair~        2. To reduce morbidity with the same outcome~   "
152241|NCT01573637|"~     The efficacy of raloxifene versus placebo was compared over a six-month period, as an~     adjuvant treatment of the negative symptoms of schizophrenia in a group of 80 post-menopausal~     women. The aim of the study is to analyze whether raloxifene has an effect on the positive~     and negative symptoms of schizophrenia, and on psychopathological symptoms in general, and on~     social and neuropsychological functioning, and to study the influence of genetic~     polymorphisms in treatment response.~   "
152290|NCT01572987|"~     This clinical trial will evaluate a patient population with Barrett's esophagus(BE)~     containing high grade dysplasia or intramucosal cancer and compare the effects of~     endoscopically-guided radiofrequency ablation system(RFA) and endoscopically-guided stepwise~     endoscopic mucosal resection(S-EMR).~   "
152242|NCT01573624|"~     Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in~     combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled~     Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.~      Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic~     bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms~     on large and small airways. Most of the experience with older anti-cholinergics had been with~     acute use and little is known about their effect in chronic use in asthma. This is a~     multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled~     GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and~     Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each~     eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3~     treatment periods per subject. The total duration of subject participation is approximately~     14 weeks.~   "
152243|NCT01573611|"~     Constituents of grapes have been studied for their antioxidant, anti-inflammatory, and~     anticarcinogenic properties. In the past decade, there has been emerging evidence regarding a~     potential role for grapes in slowing cognitive decline and other effects of aging.~     Furthermore, evidence has been obtained in vivo that supplementation of aged rats with grape~     seed extract improves cognitive performance. Despite the promising accumulating data~     supporting the use of grapes as a safe and effective strategy for delaying the incidence of~     dementia, it remains unclear how grape intake would be useful with respect to factors such as~     dose schedule or stage of dementing illness. In general, well-controlled experimental data~     obtained in human subjects is in need of much further development. The investigators aim to~     measure effects of grape intake on cerebral metabolism and cognitive function, and to~     determine whether initial patterns, and magnitude of change, of cerebral metabolism assessed~     by positron emission tomography (PET) can serve respectively as a predictor of, and biomarker~     for, the magnitude of cognitive changes resulting from intake of grapes.~   "
152244|NCT01573598|"~     Safety and Efficacy of Vilazodone in Major Depressive Disorder~   "
152245|NCT01573585|"~     The purpose of this study is to determine whether FAST (Fast muscle Activation and Stepping~     Training) exercises will improve walking balance in individuals after stroke to a greater~     extent than usual care.~      Hypothesis: The primary hypothesis is that improvements in walking balance will be larger~     following 12 sessions of FAST exercise retraining compared to usual care in persons in the~     sub-acute phase after stroke.~   "
152246|NCT01573572|"~     Due to the lack of information generated in the pivotal phase III trials assessing potential~     effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal~     endothelium, the FDA requested clinical information from a 1-year (minimum) clinical study to~     support that there are no adverse effects on the corneal endothelium following intravitreal~     injections of Macugen.~   "
152247|NCT01573559|"~     This study serves as a comparison study between the EPIC ClearView and a predicate device.~   "
152248|NCT01573546|"~     ENLIGHTEN will examine the effects of exercise, the dietary approaches to stop hypertension~     diet (DASH), and a combined exercise and DASH intervention on cognitive function among adults~     with cardiovascular disease (CVD) risk and cognitive deficits. Participants will be~     randomized to one of the three treatments, or a health education control condition, for 6~     months, and will complete assessments of CVD health and cognitive function before and after~     treatment.~   "
152249|NCT01573533|"~     The purpose of this study is to determine whether Rituximab therapy is safe and effective in~     treating patients with the kidney condition, focal segmental glomerulosclerosis (FSGS), that~     is no longer responsive to traditional therapies.~   "
152250|NCT01573520|"~     Controlling secondary hyperparathyroidism (sHPT) in maintenance hemodialysis (MHD) patients~     is cumbersome, partly due to patient's non-adherence to prescribed drugs.~      The main objective of this study was to assess whether an integrated care (IC) approach, in~     which adherence data are integrated in the decisional process, led to improved therapeutic~     control of secondary hyperparathyroidsm and higher percentages of bone metabolism targets as~     compared to a usual care (UC) approach, in which biological values represent the main stem of~     the decisional process.~      The predefined hypothesis was that patients of the IC group should reach the iPTH targets~     using 25% less doses of cinacalcet at 6 months than those of the UC group.~   "
152251|NCT01573507|"~     Background: Although glucose is essential to cerebral function, abundant experimental and~     clinical evidence demonstrates that endogenously released lactate, rather than glucose, is~     the preferential energy substrate for the brain in conditions of stress and acute injury. In~     patients with severe Traumatic Brain Injury (TBI) and aneurysmal subarachnoid hemorrhage~     (SAH) monitored with cerebral microdialysis and brain tissue oxygen (PbtO2), our preliminary~     data show that increased brain extracellular lactate is frequently observed. Our findings~     indicate that elevated brain lactate more often occurs in the absence of brain~     hypoxia/ischemia and is mainly the consequence of increased cerebral glycolysis, i.e. it~     occurs in association with high extracellular pyruvate. These data suggest that the primary~     source of elevated lactate is activated glycolysis and strongly support the concept that~     endogenously released lactate can be utilized by the injured human brain as energy substrate.~     They prompt further investigation to examine whether exogenous lactate supplementation can be~     a valuable neuroprotective strategy after TBI or SAH. Indeed, in animal models of brain~     injury, administration of exogenous lactate improves neuronal and cognitive recovery.~      Hypothesis: The investigators test the hypothesis that lactate therapy, administered during~     the acute phase of TBI or SAH, might exercise neuroprotective actions by restoring brain~     energetics and improving brain tissue PO2 and cerebral blood flow (CBF).~      Aim of the study: The aim of this single-center study is to examine the effect of sodium~     lactate infusion on cerebral extracellular metabolites, brain tissue PO2 and cerebral blood~     flow, measured with CT perfusion and transcranial doppler (TCD).~      Design: Prospective phase II interventional study examining the effect of a continuous 3-6~     hours infusion of sodium lactate (20-40 µmol/kg/min), administered within 48 hours from TBI~     or SAH, on cerebral extracellular glucose, pyruvate, glutamate, glycerol, PbtO2 and CBF.~   "
152263|NCT01573338|"~     This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin~     / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated.~     Every patient will receive drug treatment, there is no placebo group. Different groups of~     patients will receive different dosages of BAY1000394 to determine the safety and maximum~     tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy~     is the standard dose usually administered and will not change.~      The study will also assess how the drug is metabolized by the body and changes in tumor size.~      BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will~     stop if the tumor continues to grow, if side effects occur which the patient can not tolerate~     or if the patients decides to exit treatment.~   "
152264|NCT01573325|"~     The purpose of this study is to describe the HRQoL in those with MELD scores </= 15 in a~     single center for those who are pre-liver transplant candidates~   "
152252|NCT01573494|"~     Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as~     a prognostic factor and predictor of therapeutic response. The detection of CTC by~     immunomagnetic method has proved its reliability and its usefulness for monitoring breast~     cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch,~     Veridex LLC) was approved by the FDA in these indications. However, to date there is no~     reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA~     by reverse specific melanoma is disappointing. Recently, a new detection system of CMC~     immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the~     advantage of combining immunomagnetic selection step and a step of identifying by~     immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown~     encouraging results. The investigators propose a prospective study of the CellSearch system~     in patients with melanoma.~      Primary objective: To determine the effect of treatment on the number of circulating melanoma~     cells in patients with metastatic melanoma.~      Secondary objectives:~        -  determine the percentage of patients with metastatic melanoma with melanoma cells~          circulating~        -  seek a relationship between the number of circulating melanoma cells and prognosis in~          patients with metastatic melanoma~        -  seek a relationship between the change in the number of circulating melanoma cells~          before / after treatment and tumor response in patients with metastatic melanoma~   "
152253|NCT01573481|"~     The purpose of the study is to compare pressure controlled continuous mandatory ventilation~     versus pressure support ventilation during the night for weaning to mechanical ventilation in~     chronic obstructive pulmonary disease patients and their impact onto sleep quality.~   "
152254|NCT01573468|"~     This study is being performed to evaluate the efficacy and safety of capecitabine in~     combination with tesetaxel versus capecitabine in combination with placebo as second-line~     treatment for patients with gastric cancer.~   "
152255|NCT01573442|"~     This randomized phase III trial studies testosterone to see how well it works compared to~     placebo in treating postmenopausal patients with arthralgia (joint pain) caused by~     anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia~     associated with the use of aromatase inhibitors, such as anastrozole or letrozole.~   "
152256|NCT01573429|"~     Background:~      - Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and~     thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and~     water from plastic products, including water and baby bottles. However, not all of the risks~     of BPA are known. Researchers want to learn more about how BPA acts in the body, and how the~     body gets rid of BPA.~      Objectives:~      - To study controlled exposure to BPA and its effects on the body.~      Eligibility:~      - Healthy, non-obese volunteers between 25 and 45 years of age.~      Design:~        -  Participants will have six visits over about 2 to 4 weeks for this study.~        -  At the first visit, participants will be screened with a physical exam and blood and~          urine tests. They will complete a questionnaire about exposure to BPA-containing~          products. They will also receive a list of medications that should not be taken during~          the study period.~        -  The second visit will last about 13 hours. Participants will fast for 8 hours before the~          visit. They will then have a single dose of d-BPA (a modified form of BPA that is easier~          to study in the body). Regular blood samples will be taken over the 13-hour visit. All~          urine will also be collected. Participants will receive breakfast and lunch during the~          visit.~        -  Participants will have four follow-up visits. They will collect and store all of their~          urine between each follow-up visit. Blood samples will be collected at the follow-up~          visits.~   "
152257|NCT01573416|"~     Alcohol and drugs consumption are among the highest risk factor for health in Chile and~     abroad. In Chile, harmful use of alcohol continues to be a major contributor to the burden of~     disease while lost years of healthy life are higher than many other risk factors such as~     hypertension, overweight and obesity, and hyperglycemia. It is important to say that the~     impact of alcohol consumption is greater in younger age groups where fatal injuries occur~     relatively early in life, as well.~      In Chile, the consumption pattern in 2008 showed that 49.8 % consumed at least once in the~     last month for alcohol, 3.5 % for marihuana and 1.3 % for cocaine. This prevalence was even~     greater in young adults and adolescents and is associated with other mental health issues and~     poorer life quality. Those who have consumed marihuana during the last year, 25% report~     dependence symptoms. For cocaine derives, dependency rises up to 50% among the consumers.~     This data reinforce the need to design and implement strategies for reducing alcohol and~     drugs consumption in our population.~      Also, it is well known that a high number of those who suffers from any addiction problem do~     not get attention in a specialized center. The are many barriers to do so, such as lack of~     motivation, lack of resources, social problems, access to care problems, and so on.~      Chile has a shortage of preventive interventions for those at risk to develop an addiction at~     an early stage of substance use because front line health services (Primary health care and~     emergency care) and other social services (police stations, local justice courts) do not have~     a screening system and a model of brief intervention.~      The Pontificia Universidad Catolica de Chile, through its Addiction Studies Center (CEDA UC)~     and its Department of Family Medicine, is working in conjunction with SENDA (Servicio~     Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol ) to design,~     implement and evaluate a communal system for early detection, brief intervention and referral~     to treatment (SBIRT), in people older than 18 years, with substance consumption in five~     municipalities in the country.~      The aid of this study is to demonstrate that a model of brief intervention is more effective~     than the approach currently used in patients with substance use at moderate risk~     (i.e.follow-up). It is a multicentric randomized controlled trial, single blind, with a group~     to receive brief intervention and a control group that is kept in control and waiting list~     being re-evaluated three months later.~      The target population is composed by users whose ASSIST screening scores place them in the~     moderate risk group, for which there has not been defined a structured intervention yet by~     our health system. The information will be obtained from the scores obtained after the~     application of the ASSIST-WHO questionnaire.~   "
152258|NCT01573403|"~     This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical~     study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as~     well as its safety in healthy volunteers.~      DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is~     hypothetically more potential than PPIs in suppressing gastric acid as our previous~     preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+~     ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression. It~     is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.~   "
152259|NCT01573390|"~     1. Quantitative validation of non-contact oxygenation imaging by the CWC imaging system~        2. Quantitative validation of non-contact vascular function imaging by the CWC imaging~          system~        3. Evaluation of the clinical usability of the CWC imaging system for further technology~          development and engineering improvement~   "
152260|NCT01573377|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies in~     reproductive-age women, and it affects 5-7% of this group. It is characterized by disturbed~     menstrual cycle, ovulatory dysfunction and hyperandrogenism. Over 40% of PCOS women might~     become the patients with impaired glucose tolerance or type 2 diabetes. It has been confirmed~     that insulin resistance (IR) is a common feature in PCOS and adipokines might play roles in~     the pathogenesis of IR and PCOS, because these adipokines have wide-ranging effects on~     carbohydrate and lipid metabolism.~      The present clinical trial intends to compare the effects of metformin and oral~     contraceptives on PCOS patients, focusing on the insulin sensitivity, ovulation, and~     menstrual cycle etc. The investigators also aim to study the effects of metformin on serum~     adipokine levels(such as pigment epithelium-derived factor, progranulin etc.)in PCOS~     patients.~   "
152261|NCT01573364|"~     The aim of this observational study is to evaluate the pulmonary hyperinflation and its~     immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent~     asthmatic patients with dyspnea.~   "
152262|NCT01573351|"~     The purpose of this study is to assess efficacy, as determined by the proportion of subjects~     with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C~     virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.~   "
152278|NCT01573143|"~     The purpose of STICS trial (Statin Therapy In Cardiac Surgery) is to test whether~     perioperative treatment with Rosuvastatin 20 mg once daily prevents post-operative atrial~     fibrillation and reduces perioperative irreversible myocardial damage in patients undergoing~     elective cardiac surgery.~   "
152279|NCT01573130|"~     The purpose of the study is to investigate the effects of an internet-administered,~     therapist-assisted physical exercise program for the treatment of depression.~   "
152265|NCT01573312|"~     This is a single center, randomized, double-blinded, controlled, Phase I, small targeted~     prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old,~     inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an~     intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005)~     virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or~     without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses~     administered 28 days apart. This study will use a systems biology approach to assess the~     human early gene and protein signatures expressed at Days 1, 3, 7, and 28 after the first~     vaccination. The systems data will be integrated with immunogenicity and reactogenicity data~     to develop a systems model of the human immune response to A/H5N1 vaccine with or without~     AS03 adjuvant.~   "
152266|NCT01573299|"~     Even if it is a daily questioning for the stroke physician, no concrete recommendation exists~     regarding the time-point of the mobilization of stroke patients. In this study, we will~     compare two mobilisation strategies: early versus delayed verticalisation. 400 ischemic~     stroke patients will be included in this prospective randomized controlled trial, equally~     distributed in two groups. In the early mobilisation procedure the patient is allowed to go~     and sit outside of the bed the day after the stroke onset, whereas in the other arm, this~     procedure is delayed to the third day after stroke onset. The outcome in both groups will be~     assessed by the modified Rankin Scale at 3 months, which is commonly used in stroke study to~     investigate the functional outcome of the patients.~   "
152267|NCT01573286|"~     This protocol outlines a randomized,open label trial examining the safety, pharmacology and~     efficacy of Glucagon like peptide 2 (GLP-2) in infants and children with intestinal failure.~     The investigators hypothesize that GLP-2 given subcutaneously in these patients will be well~     tolerated, and have similar metabolism to what has been shown in adults. The investigators~     also expect to show an improvement in the tolerance of enteral nutrition, and a decreased~     requirement for intravenous feeding.~   "
152268|NCT01573273|"~     Stress is likely involved in relapse to cocaine use. This project will investigate the role~     oxytocin may play in the stress response in cocaine-dependent men and women and examine how~     oxytocin may impact brain activity in individuals exposed to cocaine-related cues.~   "
152269|NCT01573260|"~     Parkinson's disease involves many motor difficulties as well as non-motor ones. Recent~     research has strongly suggested that exercise is very important for Parkinson's disease. We~     are interested especially in dance as a form of exercise, because it combines physical~     movements with balance tasks, social engagement, and mental stimulation. Therefore, we think~     dance classes may be a very beneficial exercise for Parkinson's disease; the purpose of this~     study is to see if Argentinean Tango classes might improve motor and non-motor manifestations~     of Parkinson's disease.~   "
152270|NCT01573247|"~     This Phase 1/2 study consists of two parts. The purpose of Part 1 of the study is to examine~     the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for~     further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia (AML).~     The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML.~   "
152271|NCT01573234|"~     Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best~     practice clinical care in subjects with cut injuries and abrasions with particular regard to:~     Wound healing (complete reepithelialization) and patient's pain.~      In the context of the study will be collected secondary outcomes related to type of lesion~     and its clinical evolution through the analysis of the items in the scale of the Pressure~     Sore Status Tool(PSST).~   "
152272|NCT01573221|"~     Evaluation of the sensitivity and specificity of PMSI to identify the burden of stroke in~     France,from 2500 cases~   "
152273|NCT01573208|"~     The goal of the study is to know if the reconstruction of the lower limb mechanical axis and~     the patient knee function is improved after Total Knee Arthroplasty (TKA) using patient~     specific instruments.~   "
152274|NCT01573195|"~     The purpose of this study is to pilot the use of best practices alerts to enhance an~     antimicrobial stewardship program using the electronic medical record, EPIC.~   "
152275|NCT01573182|"~     The purpose of this study is to determine whether vaccination of stem cell donors with~     Zostavax can reduce the rate of Herpes Zoster reactivations in transplant recipients.~      The clinical hypotheses is: 1) that Zostavax given to stem cell donors will induce protective~     VZV specific T cell proliferation in allogeneic stem cell transplant recipients that can be~     transferred to recipients; 2) and that donor vaccination with Zostavax is safe for transplant~     recipients as measured by viral load measurement by polymerase chain reaction assay (PCR) at~     the time of stem cell donation.~   "
152276|NCT01573169|"~     Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism.~     Intermittent pneumatic compression combined with elastic stockings have been shown to be~     superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis~     after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are~     ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic~     stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism~     in patients with ICH because the use of anticoagulants may cause an enlargement of the~     hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and~     safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous~     intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated~     compression stockings and/or intermittent pneumatic compression and/or early mobilization)~     will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke~     onset.~   "
152277|NCT01573156|"~     Vascular Targeted Photodynamic therapy (VTP) with the Vascular Occluding Agent (VOA) WST11,~     may offer an alternative, providing tumour destruction via a minimally invasive approach. In~     this investigation, the investigators plan to use the WST11 VTP procedure to treat a~     predetermined small renal tumour targets. Patients will be given a general anaesthetic, to~     ensure immobility, and prevent discomfort during treatment sessions. Treated patients will~     then undergo surgical resection of their tumours, and the accuracy and reliability of tissue~     death with VTP will be assessed histologically. The aim of this proof of concept study is to~     demonstrate whether this modality has potential for a clinical role in the treatment of~     oncological kidney disease, either as an alternative to surgery, or where surgery is not~     feasible.~   "
152281|NCT01573104|"~     The investigators have a new technique of looking at urine to see whether it contains protein~     fragments that are released by damaged kidneys. These fragments seem to be more accurate than~     the current blood tests that the investigators use to diagnose renal failure. This technique~     needs to be validated with a group of patients that have a relatively high incidence of renal~     failure, cardiopulmonary bypass.~      The investigators hypothesise that using novel markers of renal dysfunction will identify~     patients who go on to develop renal failure earlier, and in a higher number than the standard~     blood tests.~      The investigators aim to collect urine from patients before going onto bypass, and then at~     Day 1 and Day 2 after bypass. This urine will be analysed for protein fragments, as well as~     other new markers of renal dysfunction. The investigators will also take blood at baseline~     and for the first two days in Cardiac Intensive Care, and compare the accuracy of the new~     tests with the 'gold standard' that is creatinine.~   "
152282|NCT01573091|"~     The purpose of the study is to collect some parameters (clinical, electrical, radiographic,~     echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.~   "
152283|NCT01573078|"~     The purpose of this study is to determine whether emotional processing and somatic~     dissociation influence IBS-like symptoms in Crohn's Disease patients.~   "
152284|NCT01573065|"~     The purpose of this study was to determine whether a brief counseling intervention coupled~     with rapid HIV testing was feasible and effective at decreasing alcohol consumption and~     sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department.~   "
152285|NCT01573052|"~     A randomized, double-blind controlled trial comparing treatment outcomes between~     chloriazepide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent~     veteran subjects. The objective of this trial is to compare the safety and effectiveness of~     these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin~     over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence,~     withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and~     alcohol craving.~   "
152286|NCT01573039|"~     CMV disease is a challenge to the success of renal transplantation. Recently, the~     investigators analyzed data from 792 renal transplant recipients performed at our hospital~     between 1999 and 2005. After the usual exclusions, 663 patients were analyzed. This~     population showed that the incidence of CMV disease is stable and occurs in approximately~     20-22% of all patients and invasive disease in approximately 5% every year. In seronegative~     patients and those receiving anti-lymphocyte (AL), CMV prophylaxis, done with ganciclovir for~     90 days is our routine and in the majority of transplant centers. In seropositive patients~     without associated risk factors (such as the use of AL) universal prophylaxis is not done.~     Rather, in this group, early diagnosis, by detection of antigenemia or viremia by~     quantitative PCR, is performed in patients who show symptoms compatible with CMV disease. In~     the investigators analysis the incidence of CMV disease in seropositive patients is around~     16%. These patients are usually hospitalized and treated with GCV IV for 14-21 days. This~     leads to an additional costs of admissions, biopsies for the diagnosis of disease invasion,~     etc. Besides these costs, the survival of the grafts in the long run is lower in patients~     with CMV disease than in those without CMV, particularly when associated with acute~     rejection. In recent years, monitoring of viremia (PCR / antigenemia) and preemptive~     treatment when it reaches substantial values, have increasingly been suggested. Patients in~     whom the detection of viremia in progressive values is detected would be treated as~     outpatients before the disease develops. To turn this hypothesis into reality, there is an~     urgent need to define cutoff values for CMV-PCR in the detection of developing CMV disease.~   "
152287|NCT01573026|"~     The purpose of this research study is to document the use if the Keystone Dental Genesis~     Dental Implant System in standard clinical use and to provide 5 year survival data.~   "
152288|NCT01573013|"~     In a cross-sectional study allotted by the ethical committee of the ETH Zurich, we are~     investigating the extent of anemia, iron deficiency and lead intoxication in young children.~     For this purpose an assessment of body lead burden and iron status was conducted in a cohort~     of individuals residing in areas of presumed high lead exposure. Associations between lead~     burden and iron status will be investigated in the near future (current status of the study).~      In a follow-on intervention study, the effect of iron fortification with and without NaEDTA~     on blood lead levels in lead-exposed children will be evaluated; and the relative impact of~     these two strategies on child growth, motor and cognitive test performance will be compared.~      This study will investigate the potential use of iron fortification to not only combat anemia~     but also reduce body lead burden in lead-exposed populations; it specifically investigates~     whether iron fortification with NaFeEDTA could have additional beneficial effects to iron~     alone.~   "
152289|NCT01573000|"~     Subjects were randomized to receive either tositumomab (Anti-B1 Antibody) and iodine I 131~     tositumomab (Arm A) or unlabeled tositumomab (Arm B). Subjects randomized to Arm B were~     allowed to cross over and receive I 131 tositumomab once their disease had progressed as long~     as they still fulfilled the protocol entry criteria (except for exclusion criterion 12, prior~     monoclonal antibody therapy) and were human anti-murine antibody (HAMA) negative. Study~     endpoint assessments of response were conducted by a Masked Independent Randomized~     Radiographic and Oncologic Review (MIRROR) panel and the Study Investigators' assessments of~     safety and survival. Subjects who completed at least two years of follow-up in Protocol~     BEX104515 (formerly Corixa Protocol RIT-II-002) were enrolled in long term follow-up Protocol~     BEX104526 (formerly Corixa Protocol CCBX001-051), an administrative protocol, for continued~     radiographic response evaluations and safety evaluations every 6 months for years 3 through 5~     post-treatment and annually for years 6 through 10 post-treatment. Subjects in BEX104526 were~     assessed for survival, disease status, subsequent therapy for NHL, and long-term safety,~     including the use of thyroid medication, development of hypothyroidism, human anti murine~     antibody (HAMA), myelodysplastic syndrome, acute myelogenous leukemia, and all other~     secondary malignancies. Additionally, subjects were followed for the development of any~     adverse event(s) deemed by the Principal Investigator as being possibly or probably related~     to a subject's previous treatment with Iodine I-131 tositumomab. Laboratory evaluations~     consisting of a thyroid stimulating hormone level and a complete blood cell count, with a~     differential and platelet count, were obtained annually through year 10 post-treatment.~      Dosimetric Dose: Subjects received 450 mg of tositumomab IV followed by 5.0 mCi of Iodine~     I-131 and 35 mg of tositumomab. Following the dosimetric dose, whole body dosimetry was~     performed on each subject using a total body gamma camera. Whole body anterior and posterior~     whole body images were obtained at the following timepoints.~        1. Within one hour of infusion of the dosimetric dose and prior to urination~        2. 2-4 days after infusion of the dosimetric dose, following urination~        3. 6-7 days after infusion of the dosimetric dose, following urination Therapeutic Dose:~          The total body residence time, derived from total body gamma camera counts obtained at~          the 3 time points, was used to calculate the iodine-131 activity (mCi) to be~          administered to deliver the therapeutic total body irradiation dose of 65 or 75 cGy. The~          therapeutic step was administered 7-14 days after the dosimetric step and consisted of~          tositumomab 450 mg followed by an activity (mCi) of iodine-131 calculated to deliver 75~          cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg of~          tositumomab.~      For subjects with ≥150,000 platelets/mm3, the recommended dose was the activity of iodine-131~     calculated to deliver 75 cGy of total body irradiation; for subjects with NCI Grade 1~     thrombocytopenia (platelet counts ≥100,000 but <150,000 platelets/mm3), the recommended dose~     was the activity of iodine-131 calculated to deliver 65 cGy of total body irradiation.~   "
152292|NCT01572961|"~     Current stimulation induces microvascular dilation in human skin. The investigators aimed to~     study (1) whether the current vasodilation is amplified after two segmental current~     stimulation as compared to one stimulation; (2) whether this amplification relies on~     prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover~     trial is conducted in Angers, France.~   "
152293|NCT01572948|"~     The purpose of the study is to propose that roflumilast is associated with meaningful~     reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including~     confirmation of previously described results, and correlate these findings with improvement~     in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD.~     The investigators aim to demonstrate this regardless of concomitant medication use, including~     inhaled corticosteroids. Additionally, the investigators hope to provide a mechanistic~     pathway by which these effects occur.~   "
152294|NCT01572935|"~     Background: Recent evidence from several countries has emerged suggesting that the increase~     in the prevalence of childhood obesity has slowed down substantially, or even leveled off.~     Also in Switzerland this trend has been observed. In 2002, 20.3% and 19.1% of boys and girls,~     respectively, were overweight or obese in Switzerland. In 2007, the prevalence of overweight~     was significantly lower, with 11.3% and 9.9% of school-aged boys and girls, respectively,~     being overweight or obese. Further trend analyses are necessary to confirm that the~     stabilizing trend observed reflects a long-term change in the rates of childhood overweight~     and obesity.~      Objective and Methods: The aim of the present study is to repeat the 2002 and 2007 national~     studies, in order to monitor the trend in the prevalence of overweight and obesity in 6-12~     year old children in Switzerland during this 5 respectively 10 year time period. Height and~     weight will be measured and used to calculate body mass index (BMI). BMI references form the~     Centers for Disease Control and Prevention will be used to determine the prevalence of~     underweight (< 5th percentile), overweight (≥ 85th and < 95th percentile) and obesity (≥ 95th~     percentile). Waist and hip circumference will be measured. Moreover, skinfold thicknesses and~     bioelectrical impedance analysis will be performed to calculate body fat percentage.~   "
152295|NCT01572922|"~     Iron overload is a severe complication of multiple blood transfusions. As the body has no~     physiologic mechanism for clearing iron, repeated transfusions cause iron accumulation in~     organs and lead to iron toxicity. Accurate assessment of iron overload is paramount to~     quantify excessive iron accumulation and to monitor response to iron chelation therapy.~     Magnetic resonance imaging (MRI) methods have been used to noninvasively measure hepatic iron~     concentration (HIC). Although MRI-based measurements of transverse relaxation rates (R2 and~     R2*) accurately predict biopsy-proven HICs below 15 mg Fe/g, previous studies have shown that~     their precision is limited for HICs above 15 mg Fe/g and inaccurate above 25 mg Fe/g. Current~     R2* gradient-echo (GRE) MR techniques fail occasionally for very high iron overloads (HIC ~~     15-25 mg Fe/g) and always for massive iron overloads (HIC > 25 mg Fe/g) because R2* is so~     high that the MR signal decays before it can be measured accurately.~      Overall accrual: 235 (200 patients, 35 healthy volunteers)~      Purpose: To determine if a new MRI (UTE) can measure the amount of iron in the liver of~     people with large amounts of iron and compare the results with the same patient's liver bx.~     Estimated patient accrual is 200. It is estimated that 41 of these patients will have~     clinical indication for liver biopsy.~      Volunteer purpose: To test the UTE MRI to ensure it runs correctly before testing in~     patients, collect data of normal values of iron in the liver in people without iron overload~     using the UTE MRI and to compare the current MRI (GRE) with the UTE. The UTE MRI will give an~     accurate value of liver iron in patients with large iron deposits in the liver, therefore~     providing an accurate means to diagnose, monitor, and provide treatments for participants.~     This new technology will impact the care of many different populations with iron overload,~     such as patients with sickle cell disease and thalassemia. Estimated accrual for healthy~     volunteers is 35.~   "
152296|NCT01572909|"~     The purpose of this research study is to assess the effectiveness, safety and tolerability of~     an investigational drug, called Bendavia, on reducing the area of heart muscle affected by a~     myocardial infarction (heart attack) in participants who have undergone successful coronary~     intervention (heart treatment) and stenting.~      Participation in the study is due to last for approximately 7 months. It is planned that up~     to 300 participants will take part in the study from centers in the United States and around~     the world.~   "
152297|NCT01572896|"~     The purpose of this study is to demonstrate the effectiveness of the Taking Charge: Managing~     JIA Online Internet intervention, when compared with an attention (static education only~     websites) control group in improving pain and HRQL as well as other health outcomes (anxiety,~     depression, treatment adherence, pain coping, knowledge, and self-efficacy) in adolescents~     with JIA. The proposed study will enroll and randomize 294 adolescents with JIA attending 10~     pediatric rheumatology hospital clinics in the Canada to either the experimental or control~     groups.~   "
152298|NCT01572883|"~     The purpose of this study is to determine whether concomitant radiotherapy and trastuzumab~     (patients treated for early breast cancer) is really safe for the heart even years after~     treatment and if the investigators should use these two treatments concomitantly without~     additional harm.~   "
152299|NCT01572870|"~     Title: Duplication in Chitotriosidase (CHIT1) Gene and the Risk for Aspergillus Lung Disease~     in CF Patients.~      Aim: To evaluate the link between CHIT1 duplication in CF patients and the predisposition to~     ABPA or persistent Aspergillus infection.~      Patients: 40 CF patients. Design: Observational, single visit. Methods: All patients will be~     assessed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1~     duplication, immunoglobulin E (IgE) and Eosinophils levels. Part of the patients will be~     assessed for RAST, skin prick test.~      Primary outcome measure is the difference in CHIT1 genotyping between the groups.~   "
152300|NCT01572857|"~     The measurement of 24-hour proteinuria allows an assessment of treatment response in patients~     with multiple myeloma. But it is difficult and restrictive to make.~      This study was therefore designed to investigate the correlation between the ratio of~     proteinuria / creatinine on samples, easier to obtain, and the 24-hour proteinuria in~     assessing response to this treatment .~   "
152312|NCT01572701|"~     This is a single arm, open label study of up to 24 high risk prostate cancer patients~     scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV~     dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As~     standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection~     (PLND) within two weeks of study drug dosing. Patients may receive a second injection of~     study drug within 24 hours of surgery to measure activity counts in tissue samples~     post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated~     for visible uptake and compared with histopathology.~   "
152313|NCT01572688|"~     The purpose of the study is to evaluate the safety and effectiveness of melphalan for~     injection for autologous stem cell transplant in multiple myeloma~   "
152301|NCT01572844|"~     Dermatomyositis is an inflammatory muscle disorder that is often associated with many skin~     findings. One of the skin findings seen in up to 50% of individuals with juvenile~     dermatomyositis, an early onset form of this condition, and up to 20-30% of adult~     dermatomyositis patients who have not responded to treatment, is calcinosis, or deposits of~     calcium within the skin and muscle tissue. In addition to being cosmetically unappealing,~     involvement of deeper tissues with calcinosis may lead to contractures, or shortening of~     muscles, which may have a significant impact on functioning and quality of life.~     Unfortunately, there is no known effective treatment of dermatomyositis associated~     calcinosis. However, recent reports have shown that a medication called sodium thiosulfate~     has been effective in treating individuals with calciphylaxis, a condition where calcium is~     deposited within blood vessels, and with tumoral calcinosis, a genetic form of calcification,~     when receiving this medication by vein. In addition, recent advances in laser technology have~     led to the development of methods that may allow topical medications to penetrate deeper~     layers of the skin. The investigators have designed a pilot study to evaluate the use of~     topical sodium thiosulfate solution in treating superficial calcinosis in individuals with~     juvenile and adult dermatomyositis. The investigators will use laser to assist in the~     delivery of this medication to areas of calcinosis.~   "
152302|NCT01572831|"~     Patients in the ICU whose infection is resolving will be randomized to standard duration of~     antibiotics compared to duration determined by a combination of a procalcitonin value and a~     simple evaluation of clinical status.~   "
152303|NCT01572818|"~     The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as~     evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron~     overload patients.~   "
152304|NCT01572805|"~     The purpose of this study is to assess the effect of melatonin on pain and amount of blood~     loss after cesarean delivery one hundred twenty women with singleton term pregnancy~     undergoing elective or emergency lower segment cesarean section under spinal anesthesia were~     included in this study. The patients were randomly allocated to one of three groups of 40~     each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of~     anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated~     Ringer's solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery~     of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic~     variables,will be recorded.Patients were instructed preoperatively in the use of the verbal~     rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If~     the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp~     100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS~     >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For~     determination of blood loss ,change in hemoglobin levels, need for additional oxytocics and~     ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin~     values were determined both before surgery and 12 h following surgery~   "
152305|NCT01572792|"~     The purpose of this Phase III study is to evaluate the long-term safety and tolerability of~     two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium~     bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic~     Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related~     quality of life assessments will also be evaluated. This extension study will include a 28~     week treatment period, followed by a four week follow up visit. All patients will remain in~     the same treatment group as for the lead-in study and continue on one of the four treatment~     arms or placebo.~   "
152306|NCT01572779|"~     A postural bio-feedback device worn by subjects for 4-10 hours a day for 6 days spread across~     6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the~     chronic group. The device records movement and muscle activity data relating to the lower~     back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration~     and aims to prompt the subject to alter their posture or position in line with~     recommendations given by the treating practitioner. Four small sensors are adhered to the~     lower back and send data wirelessly to a data logger carried in the pocket by the subject~     (the size of a small mobile phone).~   "
152307|NCT01572766|"~     The study seeks to determine the impact of assessing risk for osteoporosis in women on~     patient and physician behaviors through a pharmacist directed osteoporosis screening program.~     Women will be offered a heel ultrasound to screen for their bone density and may or may not~     be asked questions about their risk for bone fracture. Pharmacists will counsel and educate~     all women on ways to prevent the onset of osteoporosis. Women will be telephoned three months~     after the screening and asked a series of 10 questions to follow up on decisions made by~     their physicians or changes made to their health behaviors related to bone health.~   "
152308|NCT01572753|"~     This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing~     conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.~   "
152309|NCT01572740|"~     This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and~     safety of liraglutide in combination with insulin therapy compared to insulin alone in~     Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial~     insulin therapy.~   "
152310|NCT01572727|"~     This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective~     and safe in treating patients with HER2- locally advanced or metastatic breast cancer.~   "
152311|NCT01572714|"~     The objective of this study is to conduct a randomized controlled trial to examine the~     effectiveness of a telehealth intervention that supports individuals in managing fatigue and~     increasing physical activity (PA) behavior in individuals with multiple sclerosis (MS). The~     hypothesis is that a fatigue management plus physical activity intervention will~     significantly improve fatigue, quality of life, physical function, and community integration.~   "
152314|NCT01572675|"~     This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical~     practice in France as well as the use of celecoxib (Celebrex®).~   "
152364|NCT01572025|"~     -  To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to~          and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved)~          and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and~          IVF/ICSI treatment.~        -  To evaluate the feasibility of conducting a large multicentre trial~   "
152315|NCT01572662|"~     The goal of this clinical research study is to learn if giving busulfan and fludarabine~     before a stem cell transplant can help control the disease better than the standard method in~     patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses of~     busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of busulfan~     and fludarabine during the week before the stem cell transplant, rather than the standard~     method of giving 4 doses of busulfan and fludarabine only during the week before the stem~     cell transplant.~      The safety of this combination therapy will also be studied.~      Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells),~     which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants.~      Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer~     cells to die.~   "
152316|NCT01572649|"~     Primary Objective:~      - To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as~     compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric~     population (10-17 years old) and adults as controls~      Secondary Objectives:~      - To evaluate in both paediatric and adult populations:~        -  the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single~          subcutaneous ascending doses~        -  the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide~          and glucagon plasma concentrations following a standardized breakfast~        -  safety and tolerability.~   "
152317|NCT01572636|"~     This is a standard of care treatment guideline for patients with the diagnosis of~     mucopolysaccharidosis type IH (MPS I, Hurler syndrome) who are being considered as candidates~     for first hematopoietic stem cell transplantation (HSCT) according to a University of~     Minnesota myeloablative HSCT protocol.~   "
152318|NCT01572623|"~     The purpose of this study is to evaluate the efficacy and safety of two different loading~     doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural~     ischemic brain damage in patients undergoing carotid angioplasty.~   "
152319|NCT01572610|"~     A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney~     disease (CKD) patients with type 2 diabetes mellitus.~   "
152320|NCT01572597|"~     Compare efficacy and safety of 10-day triple therapy (rabeprazole, clarithromycin and~     amoxicillin) plus N-acetylcystein versus 10-day concomitant therapy (rabeprazole,~     clarithromycin, amoxicillin and metronidazole) for re-eradication for gastric Helicobacter~     pylori infection.~   "
152321|NCT01572584|"~     Background~        -  Assessment of the percentage of lung collapse is crucial in the therapeutic~          decision-making of pneumothorax.~        -  The methods normally used to this purpose are radiological. Computerized tomography scan~          (CT) is highly accurate because it allows the exact evaluation of the volume of the air~          layer. However, in clinical practice assessment of the volume of pneumothorax mainly~          relies on the measurement of the inter-pleural distance at conventional chest~          radiography (CXR). This latter method is inaccurate.~        -  Lung ultrasound is a new method highly accurate in the first diagnosis of pneumothorax,~          with a sensitivity superior to CXR and similar to CT in case of traumatic pneumothorax.~        -  The scientific community is actually debating about the usefulness of lung ultrasound in~          the quantification of pneumothorax []. Lung ultrasound can assess the superficial~          extension of the pneumothorax, but cannot evaluate its volume.~      Aim~        -  Main purpose of the study is to compare measurement of the superficial extension of~          pneumothorax on the chest wall obtained by lung ultrasound, to the evaluation of the air~          volume performed by CT in patients with pneumothorax.~        -  The main hypothesis of the study is that the cut-off between small (<11% of lung~          collapse) and large (>11% of lung collapse) pneumothorax can be identified by a lung~          ultrasound evaluation of the superficial extension of pneumothorax.~        -  Second purpose of the study is to compare the accuracies of lung ultrasound and CXR in~          predicting the volume of pneumothorax assessed by CT.~        -  Secondary hypothesis is that lung ultrasound demonstrates greater accuracy in the~          prediction of volume of pneumothorax and percentage of lung collapse.~      Methods~        -  Patients with a diagnosis of pneumothorax confirmed at CT are prospectively enrolled and~          submitted to lung ultrasound within 20 min from the CT study.~        -  Different locations of the sonographic lung point on the chest wall (i.e. the point on~          the chest wall where the sonographic pattern of the normally aerated lung alternates~          with the pathologic sonographic pattern of pneumothorax) are compared with different~          volumes of pneumothorax measured by CT.~   "
152322|NCT01572571|"~     Background~        -  Symptomatic undifferentiated hypotension represents a negative prognostic factor and the~          strongest predictor of in-hospital mortality.~        -  Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening~          conditions.~      Aim~      - The aim of the study is to evaluate the feasibility and accuracy of a new bedside~     ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins,~     in emergency.~      Methods~        -  Hypotensive (<100 mm/Hg) patients presenting to our emergency department, complaining of~          at least one of the neurologic, respiratory and cutaneous signs and symptoms of~          inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment~          of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins.~        -  On the basis of physical examination and ultrasound results, the operator declares the~          diagnostic hypothesis without influencing the attending physician and the following~          diagnostic procedure (which includes ultrasound, when needed).~        -  The diagnostic hypothesis is compared with the final diagnosis, obtained after the~          hospital route and discussed by a panel of three blinded experts (one radiologist, one~          cardiologist and one emergency physician).~        -  The statistical agreement is calculated by the k of Cohen with p-value, confidence~          intervals and raw agreement (Ra).~   "
152323|NCT01572558|"~     This is a feasibility study that will be performed at the Astrid Lindgren Children´s~     Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients,~     randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The~     study will test an computerized randomization system, the availability of patients willing to~     participate in the trial and the trial protocol. The investigators will assess the~     characteristics of the patients who agree to participate in the study and those who do not.~     The investigators will explore short term outcome and design suitable long term outcome~     measures.~   "
152324|NCT01572545|"~     The primary aim of the study is the comparative effect of zolendronic acid versus denosumab~     on serum sclerostin levels in postmenopausal women with low bone mass.~      Secondary aims are their comparative effect on serum dickkopf-1, osteoprotegerin, receptor~     activator of nuclear factor kappaB ligand (RANKL) and bone turnover markers (procollagen type~     I N-terminal peptide [PINP] and C-terminal cross-linking telopeptide of type I collagen~     [CTX]).~   "
152333|NCT01572428|"~     This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual~     white light on the colon, will improve the detection of a type of polyp called serrated. The~     polyps are called serrated because of their appearance under the microscope after they have~     been removed. They tend to be located up high in the colon, far away from the rectum. They~     have been definitely shown to be a type of precancerous polyp and it is possible that using~     Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see~     with standard white light.~   "
152325|NCT01572532|"~     The primary aim of this study is to determine the impact of community-based screening and~     treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19~     weeks) on preterm live birth in Sylhet district, Bangladesh.~      Hypothesis 1: Community-based screening and treatment of abnormal vaginal flora (Nugent score~     >4) and urinary tract infections in early pregnancy (13-19 weeks) will reduce the population~     rate of preterm live birth by at least 15%.~      The secondary aims of this study are:~        -  To determine the impact of community-based screening and treatment of abnormal vaginal~          flora and urinary tract infections on the:~             -  proportion of pregnancies with outcomes occurring prior to 37 weeks (late~               miscarriage, preterm still birth and preterm live birth); and~             -  proportion of babies with early onset neonatal sepsis.~        -  To determine the prevalence of abnormal vaginal flora and urinary tract infections,~          including asymptomatic bactiuria, among pregnant women in Sylhet district, Bangladesh.~        -  To evaluate the accuracy of simple, low-cost, point of care diagnostic tests for~          detecting bacterial vaginosis and urinary tract infections by community health workers~          in a rural, developing country setting.~   "
152326|NCT01572519|"~     The purpose of this study is to determine the safety, pharmacokinetics, and preliminary~     efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin~     lymphoma.~   "
152327|NCT01572506|"~     Background:~      - Anemia occurs commonly and is associated with poor outcomes in the elderly. In about a~     third of anemia cases in older people (over age 65), the cause of anemia is unexplained.~     Anemia in older adults may be caused by the bone marrow's inability to produce red blood~     cells fast enough to replace older red blood cells that have died. Researchers want to look~     at unexplained anemia by studying the life span of red blood cells in younger adults and~     older adults. To do so, a vitamin called Biotin will be used as a marker on the red blood~     cells.~      Objectives:~      - To investigate possible causes of unexplained anemia in older people.~      Eligibility:~        -  Individuals in the following groups:~        -  Men and women between 18 and 50 years of age who do not have anemia~        -  Men and women at least 70 years of age who do not have anemia.~        -  Men and women at least 70 years of age who have iron-deficiency anemia.~        -  Men and women at least 70 years of age who have anemia with no known cause.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have an overnight stay for the first study visit. They will provide a~          blood sample to which Biotin will be added. The blood sample with Biotin will then be~          returned to the participant. Twenty-four hours later, another blood sample will be~          collected.~        -  Participants will have up to 14 additional study visits. At each visit, blood samples~          will be collected to measure the amount of Biotin remaining in the blood.~        -  Participants may also provide a separate blood sample for genetic testing. These tests~          may provide more information about genetic causes of unexplained anemia.~   "
152328|NCT01572493|"~     Background:~      - People with cancer can have a weak immune system as a result of the cancer itself, or from~     prior treatments. . Still, treatments that stimulate the immune system have been shown to be~     effective against a number of different cancers. Recombinant human interleukin-15 (rhIL-15)~     is a drug that is designed to boost the immune system. Researchers are interested in seeing~     if rhIL-15 can strengthen the immune system's response against cancer. The drug will be given~     through a vein without a break for 10 days (240 hours).~      Objectives:~        -  To see rhIL-15 given as a continuous infusion over 10 days can be used to treat advanced~          cancer~        -  Identify the side effects associated with this treatment.~      Eligibility:~      - Individuals at least 18 years of age with advanced cancer for which there are no effective~     treatments.~      Design:~        -  Participants screening procedures will include a physical exam and medical history,~          laboratory (blood) tests and x-rays (Imaging studies) to determine suitability for the~          protocol. --Appropriate participants with easily accessible tumor deposits may also be~          asked to have one pretreatment and one post (cycle 1) treatment tumor biopsy. .~        -  Eligible participants will be admitted to the hospital for the rhIL-15 treatment and~          will spend about 12 days in the hospital. .~        -  Participants will receive one 10 day infusion each cycle (about every 42 days) for as~          long as there are no serious side effects and the disease does not progress.~        -  Participants will continue treatment as long as imaging studies show that the tumor~          continues to shrink or for two additional cycles after it has disappeared from the~          x-rays to make that the cancer is completely gone.~        -  Participants who stop treatment for side effects or because their tumor did not shrink~          or stopped responding to the treatment will continue to have follow-up visits to monitor~          the outcome of the rhIL-15 treatment until there is evidence their cancer has progress~          or they begin another treatment.~   "
152329|NCT01572480|"~     Background:~        -  Multiple myeloma is a blood cancer that affects the plasma cells. These cells help~          produce antibodies and fight infection. Smoldering multiple myeloma (SMM) is a related~          condition that may develop into multiple myeloma. The current standard of care for SMM~          is close follow-up without treatment until multiple myeloma develops. However,~          researchers are studying possible treatments for SMM itself. One possible treatment~          involves a combination of cancer treatment drugs.~        -  Lenalidomide is a drug that may help reduce or prevent the growth of cancer cells.~          Dexamethasone is a steroid that is often given with other anti-cancer drugs. These two~          drugs are an approved treatment for multiple myeloma that has not responded to at least~          one other treatment. Carfilzomib is an experimental drug that has been effective in~          treating multiple myeloma. Researchers want to combine these three drugs to see if they~          are a safe and effective treatment for SMM.~      Objectives:~      - To see if carfilzomib, lenalidomide, and dexamethasone are a safe and effective treatment~     for smoldering multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age who have SMM that is likely to progress to multiple~     myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests, and baseline bone marrow scans. Bone marrow samples will~          also be collected.~        -  Participants will have eight 28-day cycles of treatment with the three study drugs. The~          drugs will be given as tablets or as infusions. Treatment will be monitored with~          frequent blood tests and study visits.~        -  After the first four cycles, participants who are eligible for a stem cell transplant~          will have their stem cells collected and stored for future use.~        -  At the end of eight cycles, participants whose disease has not progressed will have up~          to 12 more cycles of treatment with lenalidomide tablets alone.~   "
152330|NCT01572467|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify biomarkers related to cancer.~      PURPOSE: This research trial is studying genes in tumor samples from younger patients with~     ovarian or testicular sex cord stromal tumors.~   "
152331|NCT01572454|"~     We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease~     the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients~     undergoing off-pump coronary artery bypass graft, and trying compare these effects with those~     of remifentanil infusion.~   "
152332|NCT01572441|"~     The purpose of this study is to observe parent-adolescent interactions and to examine the~     parenting behaviors and adolescent emotional and physiological responses that are associated~     with youth's substance use.~   "
152334|NCT01572415|"~     The primary objective is to identify compare SCOUT DS to random capillary glucose for~     identification of at-risk subjects with dysglycemia defined by hemoglobin A1C ≥ 6.0%.~   "
152335|NCT01572402|"~     Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides will~     be measured in patients with type 2 diabetes versus healthy subjects in a fasting status and~     in response to standard meals (at times 0', 30', 60', 120' and 180').~   "
152336|NCT01572389|"~     This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient~     Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6~     and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242~     largely rural Veterans with uncontrolled diabetes and clinically-significant depressive~     symptoms. Both groups will receive screening, education, and notification of clinical~     findings along with follow-up in usual primary care. HOPE participants will also receive~     behavioral coaching telephone sessions over a six month period. Patients in the control group~     will be screened, and providers will be notified of high risk patients' status and need for~     intervention. Both groups will receive only usual primary care during the subsequent 6 month~     maintenance period. Study measurements using self-report questionnaires will also be~     collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart~     reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from~     baseline will be compared between groups. This intervention will reach Veterans in rural~     setting where community-based primary care is needed, especially care that blends treatment~     strategies for physical and emotional health.~   "
152337|NCT01572376|"~     The aim of the study is to determine the safety and feasibility of an autologous mononuclear~     stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the~     efficacy of the treatment.~   "
152338|NCT01572363|"~     In patients with one anatomical or functional ventricular chamber, which encompasses a~     spectrum of rare and complex congenital cardiac malformations, a staged surgical approach in~     view of an ultimate Fontan operation has become the procedure of choice. Especially in the~     earlier era, perioperative mortality was the leading cause of death. However, many patients~     have a long and high-quality life, continuously improved by a better understanding of Fontan~     hemodynamics and the refinement of the surgical procedures. Nevertheless, the prospect of~     eventual failure of the Fontan circulation remains a major concern. More specifically,~     evaluation of the pulmonary circulation becomes particularly important as the failing Fontan~     circulation has become a common indication for cardiac transplantation. Although essential,~     especially in the preoperative setting, a comprehensive evaluation of the pulmonary~     circulation remains difficult in this patient population~      Our global hypothesis is that the absence of pulsatile pulmonary flow may lead to the~     development of pulmonary vascular lesions after the Fontan operation and that - together the~     absence of a subpulmonary ventricle for pressure generation - this increasing afterload will~     result in systemic ventricular underfilling and will eventually lead to a failing Fontan~     circulation.~   "
152339|NCT01572350|"~     This clinical trial is designed to investigate differences in terms of efficacy (mean change~     in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3~     therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser~     alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.~   "
152340|NCT01572337|"~     A large multicentre, randomized, controlled trial to demonstrate that non invasive~     ventilation given at an early stage of acute respiratory failure (ARF) outside the intensive~     care unit (ICU) can prevent the deterioration of ARF and the need for ICU when compared to~     the best available treatment usually performed in the non-ICU wards.~   "
152341|NCT01572324|"~     This Phase II clinical trial is to study the effectiveness and safety of continuous hepatic~     arterial infusion (HAI) of Oxaliplatin and Fluorouracil in Patients with Unresectable Biliary~     tract carcinomas, and to explore a better first-line treatment regimen for these patients.~   "
152342|NCT01572311|"~     The investigators proposed research will establish whether combining aerobic exercise with~     cognitive challenges is feasible and effective in community dwelling older adults with early~     signs of cognitive impairment.~   "
152343|NCT01572298|"~     When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of~     bone may make it impossible to place a dental implant. Guided bone regeneration procedures~     are used to re-establish a bone dimension sufficient to place a dental implant. The primary~     objective of the study is to determine whether there is any difference in the gain of~     horizontal alveolar ridge width following guided bone regeneration surgery using a combined~     autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous~     bone has historically been considered the gold standard for alveolar ridge grafting; however,~     other materials including allografts and xenografts have also been used with excellent~     results. This study evaluates the potential benefits, or lack thereof, for using a combined~     autogenous/allograft approach versus an allograft alone. The investigators will clinically~     evaluate the efficacy of this technique and determine the difference in bone formation~     between groups following healing at 5 months by observing bone growth relative to heads of~     the tenting screws placed horizontally in the locations of greatest defect in the alveolar~     ridge. A biopsy of the healed site will be taken at the time of implant placement. The null~     hypothesis is that there will be no difference in the amount of horizontal ridge width gain~     at 5 months post-grafting between the two different grafting materials (allograft alone~     versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that~     histologically, the combination graft (MinerOss®/particulate autograft) will have a similar~     percentage of vital bone present at 5 months compared to the allograft-alone group~     (MinerOss®).~   "
152344|NCT01572285|"~     The purpose of this study is to determine whether transforaminal dexamethasone injections are~     effective in the treatment of chronic Hemiplegic Shoulder Pain.~   "
152345|NCT01572272|"~     Primary:~      The purpose of this study is to assess the clinical implications of continuous distal CO2~     monitoring when used for clinical decisions~      Sub Study:~      • Evaluate the average life time (duration) of Standard Carinal VitaLine set in comparison to~     the Carinal VitaLine set that its sampling tubing is made of PEBAX (dehumidifying material).~      Description of Study Design:~      Patients will be randomized at the baseline evaluation visit into one of the following~     groups:~        -  Masked group: Data derived from the Capnostream20p will be recorded; however the medical~          staff will be masked from it and hence will not use it.~        -  Open group: Data derived from the Capnostream20p and displayed to the medical team. It~          will allow the treating physician and the nursing team to review the real time data and~          make clinical decisions based upon it if felt necessary.~   "
156872|NCT01512797|"~     The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe~     and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.~   "
152346|NCT01572259|"~     Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality~     in insulin resistant states. The typical dyslipidemia that is associated with insulin~     resistance, which includes a postprandial increase of triglyceride-rich lipoproteins (TRL)~     with excess of intestinal triglyceride-rich-lipoprotein-apoB-48 (TRL-apoB-48), is felt to~     play an important role in the accelerated ASCD. Recently, intestinal TRL-apoB-48~     overproduction appeared as a newly recognized component of insulin resistance. There is only~     a limited amount of information in the literature regarding the factors and the mechanisms~     modulating the metabolism of intestinal TRL-apoB-48 in the setting of insulin resistance~   "
152347|NCT01572246|"~     This observational protocol will evaluate the effects of monopolar electrocautery (ME) on~     implantable cardioverter defibrillators (ICDs) in patients undergoing surgery. ME can cause~     electromagnetic interference (EMI) leading to ICD damage or inadvertent ICD discharge~     (shocks). Recommended practice calls for the preoperative reprogramming of ICDs when ME will~     be used to prevent patients from receiving inadvertent shocks. This requires the presence of~     someone trained in ICD programming, but a trained person is not always readily available.~      In this study the investigators will reprogram ICDs prior to surgery according to current~     practice, but will also record what would have happened had the ICD reprogramming not~     occurred (detection on but therapy off). In addition, the investigators will evaluate the~     effect of the location of the electrosurgery unit (ESU) return pad on the incidence of EMI.~     The investigators hypothesize that directing the current return path away from the ICD will~     result in lower EMI rates than previously described.~   "
152348|NCT01572233|"~     This 4-year project will be guided by a biobehavioral model for the study of exercise~     interventions in two phases with the purposes to :~        1. explore the patients' physical activity preferences and develop doable activity lists~          during treatment period~        2. examine the changes of health-related physical fitness component over interferon~          treatment~        3. develop the Personalized Physical Activity and Psych-Education (PPAPE) Program and test~          its effects on decreasing fatigue, physical and psychological distress, and improving~          their health-related physical fitness and quality of life in patients with chronic~          hepatitis C receiving Interferon with Ribavirin Combination Therapy~        4. evaluate the outcome of the PPAPE program on increasing adherence to therapy, the~          sustained virological response (SVR) in 24 weeks after the end of treatment, and the~          time-consuming for education program during intervention.~   "
152349|NCT01572220|"~     The current study is designed to have broad generalizability and inform a potential shift~     toward greater utilization of stress echocardiography with UCA. This will be accomplished by~     comparing UCA stress echocardiography with myocardial SPECT among hospitalized patients~     presenting with atraumatic chest pain. This study seeks to demonstrate: clinical~     comparability of the 2 modalities (based on non-diagnostic test rates), improved care~     efficiency (based on length of stay), lower costs, improved provider satisfaction, and a~     presumed improved safety profile through the elimination of radiation exposure.~      Primary Hypothesis: A strategy of routine UCA (Optison™) enhanced stress echocardiography~     will result in a clinically non-diagnostic test rate comparable to myocardial SPECT among~     patients hospitalized (inpatient or hospital observation status) with atraumatic chest pain.~   "
152350|NCT01572207|"~     The purpose of this research study is to evaluate whether tailored print material can promote~     physical activity and exercise, and subsequently improve quality of life and fitness levels~     among people with multiple sclerosis (MS). Research suggests that routine physical activity~     is beneficial in people with mild to moderate MS. However, people with MS may face many~     barriers for engaging in regular physical activity. Prescribing a home exercise program and~     receiving tailored motivational print material may help people engage in physical activity.~     Thus, the investigators hope to figure out whether tailored print material can be used as~     strategy to promote physical activity and improve physical function in people with MS.~   "
152351|NCT01572194|"~     Chronic renal failure is a serious complication of lung transplantation especially in~     patients with cystic fibrosis. Their medical history prior to the Lung Transplantation has~     already exposed to kidney damage. Post-lung transplantation, these patients are subjected to~     renal toxicity anticalcineurins they receive large doses.~      The measurement of renal function of patients by formula to estimate GFR in routine use is~     unreliable and other markers seem indispensable.~      The purpose of this study is to evaluate two markers, PIIINP (Procollagen III aminoterminal~     peptide N), whose urinary levels was correlated to the intensity of fibrosis in different~     types of kidney disease.~   "
152352|NCT01572181|"~     The purpose of this study is to assess transplant-related mortality (TRM) at one year after~     allogeneic hematopoietic stem cell transplantation (allo-HSCT) prepared by a reduced~     toxicity myeloablative conditioning regimen in young patients (children and adolescents)~     with hematologic malignancies.~   "
152353|NCT01572168|"~     Cancer-related fatigue occurs in both adult and pediatric patients undergoing chemotherapy~     and/or radiation. Recently, methods to measure fatigue have improved - however, no~     non-medication interventions have been studied. Ameliorating fatigue may result in an~     improved quality of life for patients. Acupuncture is a safe and well-tolerated procedure and~     has been used for many indications in pediatric patients. Adult studies have suggested~     improvement in cancer-related fatigue after acupuncture in adults. In this trial, we propose~     using acupuncture for the treatment in cancer-related fatigue in children and adolescents~     with central nervous system tumors.~   "
152354|NCT01572155|"~     Hypothesis:~      Electrical stimulation of the abdominal vagus nerve has an anti-inflammatory effect and~     represents a new therapeutic approach to shorten postoperative ileus.~      Aims:~      In the present pilot study, the investigators want to evaluate the anti-inflammatory effect~     of peroperative electrical stimulation of the vagus nerve. To this end, the following aims~     are formulated:~        1. to optimize the technique of intra-operative electrical vagus nerve stimulation~        2. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the~          inflammatory response to abdominal surgery~        3. to evaluate whether electrical stimulation of the vagus nerve leads to clinical~          improvement (collect pilot data)~   "
152365|NCT01572012|"~     This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of~     ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously,~     intramuscularly, and orally in normal healthy volunteers.~   "
152355|NCT01572142|"~     The overarching goal of this prospective cohort study is to test the hypotheses that greater~     severity of hyposmia is associated with increased risk of cognitive decline in PD and that~     worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the goals~     of this project, patients with PD without dementia or at-risk of dementia or with dementia~     will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. AChE~     [11C]PMP or VAchT (vesicular acetylcholine transporter) [F18]-FEOBV PET will be performed~     both at study entry and at 2-years (± 6 months) follow-up. Brain MRI scans will also be~     performed at study entry and at 2-years (± 6 months) follow-up. Brain Beta-amyloid PET will~     be performed at study entry or at 2 years (± 6 months). Annual olfactory testing will be~     performed to better understand dynamic changes underlying the clinical and PET outcome~     measures.~   "
152356|NCT01572129|"~     Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with~     aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous~     coronary intervention.~      The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in~     patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous~     coronary intervention.~   "
152357|NCT01572116|"~     The aim of this study was to compare the effects of Lidocaine/epinephrine with and without~     Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in~     teeth with irreversible pulpitis.~   "
152358|NCT01572103|"~     Background: In patients with chronic HCV-related liver damage, coffee is associated with a~     reduced risk of progression and of hepatocellular carcinoma (HCC) development. Aim: This~     prospective trial is aimed at assessing the mechanisms underlying the protective effect of~     coffee on evolution in cirrhosis and HCC. Trial design/methods: Forty patients with~     HCV-related hepatitis will be recruited and randomized into two groups: the first will~     consume 4 coffee cups/day/1 month, while the second will remain coffee abstinent. At day~     30, the two groups will be switched over and exposed to coffee or not for a second month.~     Before entering the study (time 0), during coffee exposure and during abstinence we will~     evaluate the following parameters: liver function tests, viral load, 8-hydroxydeoxyguanosine~     (a marker of oxidative DNA damage), telomere length, apoptosis and collagen deposition.~   "
152359|NCT01572090|"~     Patients with overweight or obesity are in need to loose weight and represent a particularly~     challenging medical condition. Undoubtedly, any intervention achieving a negative energy~     balance over an extended time period will result in weight loss. Although several treatment~     modalities are available, currently the most extended approaches are lifestyle changes,~     pharmacotherapy, and bariatric surgery. Given the limited approved anti-obesity drugs, the~     main therapeutic strategies involve either conventional treatment or bariatric surgery.~     Conventional weight-reduction programs pursue a safe weight loss rate of 0,5-1,0 kg per week.~     The main modifiable factors affecting energy balance are dietary energy intake and energy~     expended through physical activity. In spite of the difficulty in achieving relevant and~     sustained weight loss via the conventional approach, some patients are successful in reducing~     weight and obesity-associated complications. Bariatric surgery has proved to be the most~     effective long-term treatment for weight loss and comorbidity improvement. While some of the~     surgery-induced benefits are directly dependent on adipose tissue reduction, others are due~     to specific gastrointestinal changes that take place early on and before any significant~     effects on body weight are observed. The present study contemplates the determination and~     comparison of the anthropometric and metabolic changes produced by the conventional and~     surgery-induced treatment modalities. Particular emphasis will be placed on the potential~     differential effects between conventional and surgical weight loss on body composition~     changes, circulating adipokines and gastrointestinal hormones together with their subsequent~     impact on cardiometabolic risk factors.~   "
152360|NCT01572077|"~     The purpose of this study is to evaluate patterns of metabolic activity in the heart of~     patients with pulmonary arterial hypertension(PAH). Patients with PAH are at risk of~     developing weakness or failure of the right side of the heart.It is possible that there is a~     relationship between the development of heart failure and the way the heart uses energy~     sources, such as sugar. This study is designed to evaluate the way the heart uses sugar~     uptake in patients with PAH using positron emission tomography(PET imaging)~   "
152361|NCT01572064|"~     The main purpose of this pilot study is to evaluate non-invasive magnetic resonance imaging~     (MRI) techniques in the detection and grading of liver fibrosis, so that the investigators~     can reduce the need of invasive techniques such as liver biopsy and transjugular hepatic~     venous portal pressure gradient (HVPG) measurements to assess the degree of liver scarring~     and portal hypertension.~   "
152362|NCT01572051|"~     Osteoarthritis (OA) has a major impact on mobility, disability and loss of productivity of~     patients. Patients can become disabled early in life by OA. The Osteoarthritis Research~     Society International (OARSI) is concerned to publish guidelines with the respective levels~     of evidence on the various forms of treatment of osteoarthritis of the knee and hip.It is~     believed that an education program has a positive impact on quality of life of patients with~     OA. Changing the habits of those patients is imperative for clinical improvement.~      The investigators propose the creation of an educational program consisting of various health~     professionals so that we can educate the patients about OA disease, and their role in~     treatment. This program will be administered in a single day and reviewed/reinforced after an~     interval of time. Half the patients will be monitored monthly by phone when questions~     specific to each health area will be made to participants. This way we will evaluate the~     strength of the telephone follow-up. The investigators are going to create educational~     printed an audiovisual materials for patients, so the patients can access the information~     given in the theoretical course at home. Calculation of cost-effectiveness and presentation~     of data to the authorities.~   "
152363|NCT01572038|"~     This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and~     tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane~     (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with~     metastatic or locally recurrent HER2-positive breast cancer. Participants will receive~     pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3~     weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease~     progression, or death, whichever occurs first.~   "
152370|NCT01571947|"~     There is increasing evidence suggests that elevated levels of postprandial triacylglycerol~     (TAG)-rich lipoproteins may promote the development of cardiovascular diseases (CVD). A~     prolonged and elevated postprandial lipemia is associated with increased risk of CVD by a~     variety of mechanisms such as insulin resistance, inflammation, endothelial dysfunction and~     oxidative stress. However, current evidence on the acute effects of type of fats on~     postprandial insulinaemia, gastrointestinal peptide secretion, inflammatory response, as well~     as satiation are limited and inconsistent, in particular in metabolic syndrome population in~     Asian. Hence, this study aimed to investigate the postprandial effects of high fat meals~     enriched with i) palm olein, ii) high oleic sunflower oil, and iii) high linoleic sunflower~     oil, compared with a low fat/high carbohydrate meal, in 30 subjects with metabolic syndrome.~   "
152371|NCT01571934|"~     Hemophilia A is a genetic deficiency of factor VIII that causes blood to clot too slowly. The~     disease is classified based on how much factor VIII is in the blood. People with mild or~     moderate hemophilia A have low, but detectable, blood levels of factor VIII and bleed with~     trauma or surgery. At the time of surgery, they need to receive factor VIII replacement by~     infusion into the vein so that blood can clot normally and abnormal bleeding can be avoided.~     A complication of hemophilia A is the development of an antibody that binds factor VIII and~     makes the factor VIII infused for treatment not work properly. This antibody is called an~     inhibitor. In mild and moderate hemophilia A, inhibitors are not common, but have been~     reported to occur after intensive factor VIII infusions, as may occur at the time of surgery.~     This study is designed to observe people with mild and moderate hemophilia A who are having~     surgery. Information on the surgery, treatments given, bleeding, and infection will be~     gathered. Also, blood will be drawn to determine how the immune system is reacting to the~     factor VIII. No specific treatments will be given as part of this study. We will use the~     information to determine what influences inhibitor development. A better understanding of~     inhibitor development will help medical providers do things to avoid inhibitor development in~     this population or researchers to design new treatments.~   "
152372|NCT01571921|"~     Twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written~     informed consent to participate in the trial will be recruited to compare the rate and extent~     of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation with TRF.~   "
152373|NCT01571908|"~     Magnesium accelerates the reaction of rocuronium, a neuromuscular blocker used for muscle~     relaxation to ease the intubation during anaesthesia.~      Succinylcholine is a very fast reacting neuromuscular blocker. It is often used in emergency~     procedures, when rapid intubation is necessary.~      We want to now if a perfusion of magnesium before anaesthesia accelerates to such an extent~     the reaction of rocuronium that intubation conditions are comparable or even better than with~     succinylcholine alone (prior perfusion of saline=placebo)~   "
152374|NCT01571895|"~     The study will be a phase 2, multicentre, single arm, pilot study. It has been designed to~     determine if DF2156A has sufficient activity to warrant its further development.~      A total of twelve (12) BP patients will be involved, who will be administered DF2156A orally~     at the dose of 150 mg twice a day for a maximum of 14 days.~      Recruitment will be competitive among the study sites, until the planned number of patients~     is enrolled. Competitive recruitment has been chosen to increase the speed of recruitment and~     to account for any unexpected occurrence at a site that negatively impact enrolment rate.~      The single arm design has been chosen as an appropriate tool for this pilot phase 2 study,~     considering that BP is a rare disease where a placebo control is not acceptable. Moreover, as~     there is no spontaneous acute recovery from the active blistering condition, any improvement~     in patient outcome can be attributed to a positive effect of the Investigational Product.~      Each patient will be involved in the study for a screening period, for 14 days of treatment,~     for all required measurements up to hospital discharge (planned on day 8+1 of treatment) and~     for one assessment occasion on day 15+1, either during hospital stay or after hospital~     discharge (out-patient visit). An optional post-treatment visit might be scheduled at day~     30+3.~      The objective of this clinical trial is to evaluate whether DF2156A has a potential in~     improving the clinical outcome in patients with active blistering BP to warrant its further~     development. The safety of DF2156A in the specific clinical setting will be also evaluated.~   "
152375|NCT01571882|"~     The objective of this study is to investigate the effect of consumption of a low-fat, no~     added sugar, dairy fermented product enriched with plant sterols and policosanols at two~     doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of~     product consumption versus active control product.~   "
152376|NCT01571869|"~     The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at~     different moments of the day in lowering blood cholesterol of hypercholesterolemic.~   "
152377|NCT01571856|"~     The purpose of this study is to determine the effect of zinc in acute watery diarrhea in~     children. The investigators will evaluate the effect of product versus placebo.~   "
152378|NCT01571843|"~     The purpose of the study is to determine the effect of forearm exercise on forearm bone~     density in post-menopausal women with or without primary hyperparathyroidism.~      The investigators hypothesize that forearm exercise will increase forearm bone density in~     patients with primary hyperparathyroidism more so than in patients without primary~     hyperparathyroidism.~   "
152386|NCT01571739|"~     Background:~      - Tuberculosis (TB) is a leading cause of death worldwide. Those who are exposed to the TB~     bacteria but have not become sick are said to have latent TB. Many people with latent TB will~     not get sick from it, but some people will develop active TB and become sick. Much is known~     about how to treat and diagnose active TB, but little is known about the best way to treat~     latent TB. Researchers also want to know more about the risk that latent TB will develop into~     active TB, and whether it is possible to test for this risk.~      Objectives:~      - To test possible methods of determining a person s risk for developing active TB.~      Eligibility:~      - Individuals between 20 and 60 years of age who (1) have active TB, (2) were exposed to~     someone with active TB in the past 9 months, or (3) have not been exposed to TB.~      Design:~        -  Participants will be separated into groups based on their exposure to TB.~        -  Healthy participants who were not exposed to TB will answer questions about their~          medical history. They will also provide blood and urine samples.~        -  Participants who have active TB will have a physical exam and medical history. They will~          provide blood, urine, and sputum samples, and will have a chest x-ray. They will be~          treated with the standard of care for active TB. Some participants with active TB may~          have additional tests as part of this study.~        -  Participants who were exposed to TB and have latent TB will have a physical exam and~          medical history. They will provide blood, urine, and sputum samples, and will have a~          chest x-ray. They will be asked to return for five more clinic visits over the next 12~          months to repeat these tests. They may also have additional chest imaging studies~          depending on the study needs.~        -  Some of the exposed participants may have been exposed to drug-resistant TB. These~          participants will receive the drug isoniazid to take on a regular schedule to help~          prevent the latent TB from becoming active TB.~   "
183578|NCT01161927|"~     The purpose of this study is to compare experimental evaluation of relative bioavailabilities~     in healthy, human subjects under non-fasting conditions.~   "
152379|NCT01571830|"~     -  Hypothesis 1: Food allergies are associated with poor growth which can be corrected with~          nutrition intervention.~             -  More than 10% of children with multiple food allergies will have a weight-for-age~               z-score less than - 2 at diagnosis. The z-score is a measure of the distance from~               the mean value, or 50th percentile on the growth chart. A z-score of less than - 2~               indicates that the child is underweight.~             -  Growth parameters of children with multiple food allergies will improve after~               intervention by a team that includes a dietitian and an allergist.~        -  Hypothesis 2: Food allergies are associated with low micronutrient intake which can be~          corrected with nutrition intervention.~           o More than 30% of children with multiple food allergies will consume less than 67% of~          the Dietary Reference Intake for at least one macronutrient or micronutrient at~          diagnosis.~        -  Macronutrient and micronutrient intake will increase after intervention by a team that~          includes a dietitian and an allergist.~      • Hypothesis 3: Food allergies are related to behavioral feeding problems which can be~     corrected with nutrition intervention.~        -  At least 25% of children with multiple food allergies will have behavioral feeding~          problems at diagnosis.~        -  Prevalence of behavioral feeding problems will decrease after nutrition intervention.~   "
152380|NCT01571817|"~     The overall objective of this pilot project is to evaluate the safety and efficacy of the~     gastric submucosal space as a novel site for clinical islet transplantation. The site has~     several physiologic attributes that may improve the outcomes of islet transplantation~     compared with the conventional intraportal transplant site.~   "
152381|NCT01571804|"~     Preoperative administration of pregabalin would reduce the end tidal concentration of~     sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the~     quality of postoperative analgesia.~   "
152382|NCT01571791|"~     Rheumatic heart valve diseases are prevalent among the young people in Egypt secondary to the~     socioeconomic conditions. The goal of anesthetic management of these patients is maintenance~     of sinus rhythm, systemic blood pressure, preload, coronary perfusion, and cardiac output.~     Many women still prefer general anesthesia rather than regional techniques at the author's~     country.~      The pharmacological modifications of the sympathetic response to tracheal intubation and~     surgical stimulation using opioids have adverse effects on the neonatal outcome after~     cesarean delivery. The authors have demonstrated in their previous studies the safety of both~     perioperative infusion of both of ketorolac and lidocaine in the attenuation of the~     hemodynamic and hormonal responses of tracheal intubation and surgery during cesarean~     delivery with favorable neonatal outcome and without added risk of perioperative bleeding.~     Therefore, the authors reported successful anesthetic management of a parturient with~     infective endocarditis on top of rheumatic mitral valve disease with use of~     paracetamol-lidocaine-ketorolac-propofol anesthesia.~      The investigators hypothesize that the perioperative use of ketorolac-lidocaine would reduce~     the maternal hemodynamic responses to intubation and surgery without any harmful effects on~     mother or baby during uncomplicated cesarean delivery in the parturients with valvular hear~     diseases.~      The investigators are aiming to compare the effects of ketorolac-lidocaine and fentanyl on~     surgical stress responses, intraoperative fentanyl and vasoactive drugs consumption and~     neonatal outcome during cesarean delivery in the parturients with valvular hear diseases.~   "
152383|NCT01571778|"~     The importance of healthcare worker hand hygiene in decreasing bacterial transmission between~     patients is well documented. Healthcare workers may don non-sterile gloves in routine care of~     patients, particularly for those patients known or suspected to harbor epidemiologically~     important microorganisms. Governing bodies currently recommend performing hand hygiene prior~     to donning gloves and after glove removal. The importance of hand hygiene post glove removal~     is well shown, however few studies exist to show utility of hand hygiene prior to donning~     gloves. In fact, data suggests that glove use is an impediment to hand hygiene and may reduce~     compliance with hand washing. In light of this and the fact that no evidence exists that~     washing hands BEFORE glove use is important, the aim of the study is to asses the utility of~     routine hand hygiene prior to donning non-sterile gloves before a patient contact.~   "
152384|NCT01571765|"~     The investigators will assess whether in Bushenyi District in southwestern Uganda, a two year~     intervention providing comprehensive MNCH programming will:~        -  Reduce morbidity and mortality for children under five years old and;~        -  Improve access to maternal health services Compared to a control community without MNCH~          intervention?~      Hypothesis:~      Comprehensive maternal, newborn and child health programming in Bushenyi Distrcit can have a~     positive impact on morbidity and mortality for children under five years and will improve~     access for women to maternal health services which may lead, in the longer term, to decreased~     maternal mortality.~   "
152385|NCT01571752|"~     Background:~      - Researchers have been studying patterns of mood and drug use in specific neighborhoods.~     This study will look at environmental factors that may affect drug use, addiction, and~     treatment seeking in Baltimore neighborhoods. The results could inform prevention efforts,~     enhance treatment interventions, and improve substance use outcomes.~      Objectives:~      - To better understand why some people start to use drugs, why some people who use drugs~     become addicted, and why some people who become addicted enter treatment.~      Eligibility:~      - Individuals at least 18 years of age who are living in the neighborhoods participating in~     the study.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will be~          separated into one of four groups: (1) people who do not use drugs, (2) people who have~          used drugs in the past, (3) people who are using drugs and want treatment, and (4)~          people who are using drugs and do not want treatment.~        -  This study will include two outpatient visits about 12 months apart. Each visit will~          last about 5 hours. Each study visit may be done in 1 day or in 2 days.~        -  At each study visit, participants will provide blood, breath, urine, and saliva samples.~          They will also have a heart function test and body measurements. They will complete~          questionnaires about personal and family history.~        -  There will be monthly follow-up phone calls between the two visits.~   "
152415|NCT01571362|"~     The primary objective of the study is to determine the analgesic efficacy and safety of~     ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to~     severe chronic low back pain.~   "
161206|NCT01455935|"~     The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion~     studies as an indicator to treat stroke patients with unknown time of onset.~   "
152387|NCT01571726|"~     Background:~      - Multiple myeloma (MM) is a type of malignant blood cancer. It affects the plasma cells,~     which help produce antibodies and fight infection. MM is nearly always preceded by a~     pre-malignant state, monoclonal gammopathy of undetermined significance (MGUS) or smoldering~     multiple myeloma (SMM). Currently, it is not possible to predict when someone with MGUS or~     SMM will develop MM. Also, the disease changes in those early states are not well understood.~     Researchers want to look at imaging studies of people with MGUS, SMM, and MM. They will study~     whether the growth of blood vessels can be used to predict disease progression.~      Objectives:~      - To use imaging studies to evaluate disease progression in multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age who have MGUS, SMM, or newly diagnosed MM.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests, and provide bone marrow samples.~        -  Participants will have positron emission tomography (PET) scans with the new contrast~          agent [18]F-Fluciclatide. The contrast agent is intended to show patterns of increased~          vessel growth in the bone marrow.~        -  Participants will also have a magnetic resonance imaging (MRI) scan. This scan will be~          done according to standard procedures.~        -  Researchers will compare these scans with blood tests and other clinical information to~          study disease progression of MGUS, SMM, and MM.~   "
152388|NCT01571713|"~     The study seeks to analyze the patient reported effects of pulmonary hypertension medications~     and compare these with the side effects described on the package inserts. Side effects for~     these PH medications have been described in the adult population, but have never been~     described in the pediatric population. This information can better improve patient care and~     be used to characterize the side effects resultant from these medications.~   "
152389|NCT01571700|"~     The purpose of the study is to determine whether patients with pulmonary hypertension (PH)~     have dysynchrony, and if so whether it is electrical or mechanical. Once this has been~     determined, during a catheterization the investigators will test if pacing the heart improves~     blood circulation.~   "
152390|NCT01571687|"~     Exposure to hypobaric hypoxia demands maximum effort of the body and can lead to high~     altitude illnesses. Recently, there is rising interest on coagulation activation during~     trekking and mountaineering in higher regions and on development of oxidative stress due to~     hypoxia. 30 volunteers have been examined during an high altitude research expedition to the~     7134m high mount Pik Lenin in Kyrgyzstan to investigate mechanisms of coagulation activation~     and effects of antioxidant supplements on oxidative stress.~   "
152391|NCT01571674|"~     The purpose of this study is to determine the validity of previously identified prognostic~     variables that may identify patients with shoulder pain that are likely to benefit from~     cervicothoracic spine manipulation.~   "
152392|NCT01571661|"~     This is a double blind, randomised, placebo controlled, single dose escalation,~     first-time-in-human, 5-way crossover study to assess the safety, tolerability,~     pharmacokinetic and pharmacodynamic parameters of ascending doses of GSK189075A in healthy~     subjects (Part A). Single doses will be given to 10 healthy subjects. The planned doses are~     20mg, 50mg, 150mg, 500mg, and 1000mg. Each subject will receive 4 of the 5 active doses and a~     placebo separated by a washout of 5-10 days. A second cohort of 6 subjects with type 2~     diabetes mellitus will receive 2 active doses and a placebo along with oral glucose in a~     three-way, randomised, placebo controlled, crossover design to assess glucose lowering~     following GSK189075A administration (Part B). Blood samples will be taken throughout the~     study day for pharmacokinetic analysis of prodrug and metabolites. Safety will be assessed by~     measurement of blood glucose, blood pressure, heart rate, ECGs, laboratory safety screens,~     and collection of adverse events.~   "
152393|NCT01571648|"~     The purpose of this study is to evaluate the tolerability of oral azacitidine in the~     treatment of patients with Myelodysplastic Syndromes (MDS).~   "
152394|NCT01571635|"~     Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in~     adults with Beta (β)-Thalassemia~   "
152395|NCT01571622|"~     The aim of the present study is to examine the therapeutic effect of whey protein concentrate~     (WPC 80) in adult subjects with in type 2 diabetes. Whey protein will be administered before~     breakfast and its effects on posprandial glucose, insulin, c-peptide, intact and total GIP~     and GLP-1, and DPP-4 plasma levels will be assessed.~   "
152396|NCT01571609|"~     The purpose of the present study is to conduct a thorough and relevant physiology study of~     carriers and non-carriers of the gene variant X in order to determine the effect of the~     genetic variant on various metabolic parameters.~   "
152397|NCT01571596|"~     The primary purpose of this study is to assess the safety and efficacy of repeated~     subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).~   "
152398|NCT01571583|"~     The purpose of this study is to evaluate the effectiveness of telaprevir in combination with~     Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C~     virus (HCV) genotype 1.~   "
152399|NCT01571570|"~     The purpose of this study is to evaluate the relative bioavailability and the short-term~     safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg,~     given as different formulations in healthy adult participants. In addition, this study is to~     assess for the acceptability of the taste of both liquid formulations.~   "
152400|NCT01571557|"~     This study will evaluate the relationship between time since onset of macular oedema symptoms~     and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic~     procedures provided are at the discretion of the participating physicians according to their~     clinical judgment and local standard of medical care.~   "
152401|NCT01571544|"~     Unintentional hypothermia of a patient is a common adverse effect during surgical procedures.~     The aim of this prospective, randomised, controlled study is to determine whether the use of~     thermal suit could prevent surgical patient from experiencing thermal loss than conventional~     measures.~      Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between~     the groups is clinically relevant.~   "
152416|NCT01571349|"~     The investigators are trying to investigate the coagulation status of idiopathic (immune)~     thrombocytopenic purpura patients by measuring the platelet count, coagulation battery, von~     Willebrand factor level, thromboelastography.~   "
152417|NCT01571336|"~     This study aims to collect data on the frequency of SCCs in the Alacare®-treated area during~     an interval of two years after Alacare®-PDT.~   "
152402|NCT01571531|"~     Today there is accumulating evidence from animal experiments that regeneration can be induced~     after a spinal cord injury (SCI). Consequently in the near future, new therapeutic approaches~     to induce some regeneration will be included in the treatment of patients with SCI. The aim~     of this proposal is to provide the required clinical basis for the implementation of novel~     interventional therapies. The establishment of combined clinical, functional and~     neurophysiological measures for a qualitative and quantitative assessment of spinal cord~     function in patients with SCI at different stages during rehabilitation represents a basic~     requirement to monitor any significant effect of a new treatment. Therefore, several European~     Paraplegic Centres involved in the rehabilitation of acute traumatic SCI patients build up a~     close collaboration for standardised assessment. The aim is to get knowledge about the~     natural recovery after spinal cord lesion in a larger population of patients in the sense of~     a historical control group and to bring new standardised assessment tools to the clinical~     setting.~   "
152403|NCT01571518|"~     After resection of lymph node positive breast cancer, the injection duration and timing of~     Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC~     (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.~   "
152404|NCT01571505|"~     Oral polio and rotavirus vaccines are significantly less effective in children living in the~     developing world. Tropical enteropathy, which is associated with intestinal inflammation,~     decreased absorption and increased permeability, may contribute substantially to oral vaccine~     failure in developing country settings. Other possible causes of oral vaccine~     underperformance include malnutrition, interference with maternal or breast milk antibodies,~     changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is~     to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus~     vaccines is associated with the presence of tropical enteropathy.~   "
152405|NCT01571492|"~     This prospective study is intended to compare the analgesic efficacy, preservation of lower~     extremity motor power and side-effect profile of L2 Paravertebral lumbar plexus approach~     compared to Posterior nerve stimulation guided lumbar plexus approach, continuous local~     anesthetic infusion postoperative analgesia of Total Hip Arthroplasty.~      The L2 Paravertebral technique of lumbar plexus block, as part of a multimodal pain~     treatment, could be a cost-effective alternative with a equal profile of analgesic efficacy~     and motor power sparing with greater promotion of early achievement of postoperative physical~     therapy goals.~   "
152406|NCT01571479|"~     The aim of this study was to show that this technique is feasible, safe and easily~     reproducible and to evaluate the selection criteria for a three-port laparoscopic~     cholecystectomy using a 2-mm mini-port.~   "
152407|NCT01571466|"~     30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will be~     randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will be~     observed at the Investigation Unit of the study site for one hour following vaccination. At~     week 24 they will stop their HAART until the end of the study.~   "
152408|NCT01571453|"~     This study will be conducted with the aim of investigating the efficacy, safety and~     tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active~     comparator (venlafaxine extended release 150 mg/day).~   "
152409|NCT01571440|"~     The purpose of this study was to determine the effect of soluble corn fiber on calcium~     absorption and retention and gut microflora in adolescent boys and girls.~   "
152410|NCT01571427|"~     Past epidemiological studies have demonstrated that larger social networks, or more frequent~     social interactions, could have potential protective effects on the incidence of Alzheimer's~     Disease (AD). However, in those studies, indicators of social interactions were often broad,~     and included distinct elements that affected cognition and overall health. the investigators~     will examine whether conversation-based cognitive stimulations have positive effects on~     general, and domain-specific cognitive functions among the elderly. Face-to-face~     communication will be conducted through the use of personal computers, webcams, and~     user-friendly simple interactive Internet programs to allow participants to have social~     engagement while staying at their home and also for the cost effective execution of the~     study.~   "
152411|NCT01571414|"~     Tuberculosis (TB) is a global public health concern and developing new treatment regimens is~     an important research priority. PA-824 is an experimental TB medication. This study will~     evaluate the safety and tolerability of PA-824 when combined with efavirenz (EFV) or~     ritonavir-boosted lopinavir (LPV/r), which are medications used to treat HIV infection, or~     rifampin (RIF), which is a medication used to treat TB. Study researchers will examine the~     safety and tolerability of these drug combinations and how the medications affect the levels~     of PA-824 in the blood.~   "
152412|NCT01571401|"~     Objectives: The purpose of this study is to find out if a new program can help kidney cancer~     survivors (KCS) increase their physical activity (PA) and improve their quality of life~     (QoL).~      Methods: Fifty KCS will be recruited from a previous study using the Alberta Cancer Registry.~     Participants will undergo submaximal exercise testing, a physical function test and measures~     of height and weight, which will be completed at baseline and the end of the physical~     activity program (at 12 weeks). Participants will also complete questionnaires on PA and QoL~     at the baseline, after the supervised portion of the program (at 4 weeks), and at the end of~     the entire program (at 12 weeks). Following baseline assessments, participants will be~     randomly assigned to either: (1) supervised physical activity plus traditional exercise~     counseling or (2) supervised physical activity plus behavioural counseling. Participants will~     be asked to attend six individual supervised exercise and counseling sessions over a 4-week~     period with a PA specialist that eventually tapers to a home-based program by the end of the~     program.~      Implications: The investigators hope that this PA intervention for KCS is feasible and~     results in meaningful improvements in health outcomes that can be translated to public health~     practice.~   "
152413|NCT01571388|"~     The study will determine if there are differences in how dacomitinib is absorbed and~     eliminated between healthy subjects and subjects with mild and moderately impaired hepatic~     function.~   "
152414|NCT01571375|"~     The Aim of the Study is to Measure the Effect of Finnish Physician-staffed EMS Unit Treatment~     Methods on Traumatic Brain Injury (TBI) Patient Prognosis.~      Physician-staffed HEMS unit was implemented to the EMS 2011. The aim of this study is to~     compare the results against a historical database to see if the implementation of a HEMS unit~     will improve the prognosis of TBI patients.~   "
152418|NCT01571323|"~     The purpose of this study is to demonstrate that the combined used of low dose of oxytocin~     and misoprostol prevent from post partum haemorrhage better than oxytocin or misoprostol~     alone at cesarean sectionOne hundred fifty women with singleton term pregnancy undergoing~     elective or emergency lower segment cesarean section under spinal anesthesia were included in~     this study. The patients were randomly allocated to one of three groups of 50 each. The~     oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after~     delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved~     in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately~     after delivery of the neonate ,The misoprostol group (groupM) received 400 µg sublingually~     and infusion of lactated Ringer ( which one ampoule placebo dissolved it) and the combined~     misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously~     immediately after delivery of the neonate . The main outcome measures were blood loss at~     cesarean section, change in hemoglobin levels, need for additional oxytocics and drug related~     side effects.The volume of blood in the suction bottle was measured, blood soaked sponges and~     added to volume from suction bottle. Hemoglobin values were determined both before surgery~     and 24 h following surgery. Hemodynamic variables were recorded every 5 minutes during~     surgery .The need for additional oxytocic therapy, operating time, infusion volume given~     intraoperatively, need for blood transfusion, side effects of study drug and any significant~     puerperal morbidity were also recorded.~   "
152419|NCT01571310|"~     The investigators will explore the effect of omission of breakfast on postprandial~     hyperglycemia and insulin and intact GLP-1 response after subsequent meals in type 2 diabetic~     patients~   "
152420|NCT01571297|"~     The purpose of this study is to evaluate the effects of RM-131 on gastric emptying,~     gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in~     patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed to~     evaluate the efficacy and safety of multiple dose regimens of RM-131. Study drug (RM-131 and~     placebo) will be administered subcutaneously in a blinded fashion.~   "
152421|NCT01571284|"~     Primary Objective:~      To provide metastatic colorectal cancer participants with access to aflibercept and to~     document the overall safety in these participants~      Secondary Objective:~      To document the Health-Related Quality of Life of aflibercept in this participants population~   "
152422|NCT01571271|"~     Bile duct stones that can't be removed by conventional means can often be removed after~     fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation~     of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser~     (laser lithotripsy). Although both techniques have been used for many years, there are no~     studies comparing the efficacy of the two. The purpose of this study is to find out which~     technique is more effective.~   "
152423|NCT01571258|"~     The purpose of the present RCT is to evaluate a 12-month SMS intervention with expanded~     content, intervention strategies and interactive database logic, novel online enrollment, and~     automatic baseline scoring of measures to support a 12 month weight loss SMS intervention.~     The investigators hypothesized that the intervention group would have greater weight loss at~     6 and 12 months than the control group and increased adherence to SMS would be associated~     with greater weight loss at 6 and 12 months.~   "
152424|NCT01571245|"~     Objective psychophysiologic reactivity data may be useful for predicting post-traumatic~     stress disorder (PTSD) treatment response. Given the variety of PTSD treatments and the lack~     of a clearly superior treatment, a reliable and valid approach to predicting treatment~     response is needed.~      Specific Aims: 1). Evaluate the clinical utility of psychophysiologic reactivity measures to~     predict overall PTSD symptom response among OEF/OIF/OND (Operation Enduring Freedom/Operation~     Iraqi Freedom/Operation New Dawn) veterans receiving treatment for PTSD. 2). Evaluate the~     clinical utility of psychophysiologic reactivity measures to predict psychosocial functioning~     and health-related quality of life (HRQoL) response among OEF/OIF/OND veterans in treatment~     for PTSD. Exploratory). Develop psychophysiologic, neuropsychological, and/or self-report~     models to predict PTSD symptom response to pharmacotherapy, psychotherapy, and combined~     pharmacotherapy/psychotherapy. The investigators will divide psychophysiologic reactivity~     predictors into two groups: heart rate variability and attentional bias (eye gaze tracking~     and modified Stroop). The investigators will collect observational and longitudinal data from~     a treatment-seeking sample of 50 OEF/OIF/OND veterans with PTSD recruited from the Central~     Arkansas Veterans Healthcare System (CAVHS) Mental Health Clinics.~   "
152425|NCT01571232|"~     The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone~     implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant~     diabetic macular edema.~   "
152426|NCT01571219|"~     CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc.~     This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion,~     efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess~     the long-term efficacy and safety of multiple doses of CT-P13.~   "
152427|NCT01571206|"~     This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion,~     efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess~     the long-term efficacy and safety of multiple doses of CT-P13.~   "
152428|NCT01571180|"~     Patients who have scheduled a gastric bypass (RYGB) in UZ Leuven, will be questioned~     preoperatively and one, three, six and twelve months after gastric bypass surgery. The~     purpose of this study is to explore current practice regarding the use of medication and~     medication counseling after RYGB and to examine the changes in dietary pattern before and~     after RYGB.~   "
152429|NCT01571167|"~     The primary purpose of the study is to determine the effects of treatment with varenicline (1~     and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving and~     subjective effects in methamphetamine-dependent human volunteers.~   "
152441|NCT01570998|"~     This phase IV trial studies the side effects of intraoperative radiation therapy and how well~     it works in treating patients with breast cancer undergoing breast-conserving surgery.~     Delivering radiation one time to the area where the tumor was removed while the patient is~     still in the operating room may kill any residual tumor cells and may be as effective as~     standard radiation therapy in patients with early stage breast cancer.~   "
152430|NCT01571141|"~     Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the~     development of cervical cancer. Persistence of the infection is one of the main factors~     responsible for the invasive progression and women diagnosed with intraepithelial squamous~     lesions are referred for further assessment and surgical treatments which are prone to~     complications. Despite this, there are several reports on the spontaneous regression of the~     infection.~      In this study the investigators will evaluate the effectiveness of a long term~     polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance~     reducing the time exposure to the infection and avoiding the complications associated with~     the invasive treatments currently available.~      Women diagnosed with HPV infection were randomly assigned to receive six months of treatment~     with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same~     period of time.~      The administration of Monogin® has been performed every three days for fifteen days and then~     every fifteen days for the subsequent six months.~   "
152431|NCT01571128|"~     MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a gender-specific~     combination HIV prevention package for youth (aged 15-24) in high burden settings. The study~     aims to pilot a combination package of gender-specific interventions in western Kenya in a~     mobile health delivery format using integrated services delivery.~   "
152432|NCT01571115|"~     INTRODUCTION: The primary insomnia, according to the concepts of the DSM IV, is a disorder~     characterized by difficulty initiating or maintaining sleep, waking early or by~     non-restorative sleep, resulting in losses in the daily functioning of patients, such as lack~     of attention, concentration and memory, fatigue, moodiness and irritability that are~     potentially associated with changes in sleep architecture, especially the reduction in~     slow-wave sleep. The most widely used therapy for the treatment of insomnia is the drug, but~     currently the resistive exercise is an important non-pharmacological intervention known to~     provide enough increase in slow wave sleep, and improve other parameters of sleep, as well as~     reducing symptoms of anxiety that are directly associated with the framework of insomnia.~     OBJECTIVE: To evaluate the effect of chronic resistive exercise in sleep patterns, the~     profile of mood and quality of life of patients with chronic primary insomnia. METHODOLOGY:~     30 patients will be selected (male and female) with chronic primary insomnia. (Clinical~     diagnosis based on DSM-IV) referred for ambulatory sleep disorders Sleep Institute - AFIP.~     The protocol will be conducted at the Center for Psychobiology and Exercise (CEPE) of the~     AFIP and the Sleep Institute. Volunteers will be randomized into 2 groups of 15 participants,~     which will hold a resistive exercise and the other stretching exercise. This study will~     consist of three assessments: Pre-intervention (baseline), intermediate Rating (2 months) and~     post-intervention (at the end of 4 months). In the program of resistive exercise will be held~     48 sessions that involve upper and lower limbs, abdominal and paraspinal region. It will be~     initially used a relative intensity 50% 1-RM. After 2 months of training intensity will be~     increased to 60% of 1-RM. Each exercise will be conducted in three sets of 12 repetitions, at~     intervals of 30 seconds between sets and one minute between each exercise. The total duration~     of the training session will be approximately 50 minutes. Before starting the training,~     participants will hold for 5 minutes stretching and warming on a bicycle ergometer (Life~     Cycle 9100) or treadmill (Life Fitness 9100) for the same period. After the session, the~     volunteers performed repeated stretches at the start of training. The group submitted to~     follow the practice of stretching protocol performed by Tworoger et al. that consist of 48~     sessions of stretching for 60 minutes of low intensity, three times a week. The session will~     begin with 5 minutes of walking around the room, followed by 45 minutes of stretching~     exercises that involve the upper and lower limbs, 8 to 10 types for each region and end with~     10 minutes of relaxation. STATISTICAL ANALYSIS: The variables of sleep, body composition and~     maximal repetition test will be analyzed using the software Statistica 7.0 (StaSoft, INC).~     The appropriate statistical test, parametric or nonparametric, will be chosen according to~     the data of the sample groups.~   "
152433|NCT01571102|"~     In this study we investigate whether physiotherapy offers added value in rehabilitation after~     meniscectomy compared with no therapy or a home program. The population consists of 180~     post-operative meniscus injury patients, operated at UZ Gent, the first 60 patients received~     no therapy, the next 60 patients were offered a treatment by their home physiotherapist~     according to our established protocol and the last 60 patients we have prepared a home~     program .~      The physiotherapeutic treatment has been prepared based on scientific literature and own~     experience from the program at Ghent University and internships. It includes exercises to~     promote mobility, strength and stability and exercises to reduce pain and swelling depending~     on the phase of tissue repair and evolution of the patient. This schedule will be given to~     the patient along with the questionnaires at registration of the operation and will serve as~     a guideline for the physiotherapist for the rehabilitation of the patient after surgery.~     Monitoring of the evolution will take place by calling the physiotherapist on regular basis.~      The home program is prepared on the basis of commonly used home exercises after arthroscopy~     and also includes exercises to promote mobility, strength and stability and exercises to~     reduce pain and swelling. The difference with the physiotherapeutic treatment is that there~     is no control and supervision of a physiotherapist and that the treatment is more limited.~     This program is given with the patient along with the questionnaires at registration of the~     operation.~      Pre-operatively and 4 weeks, 3 months, 6 months and 12 months post-operatively, an evaluation~     of the current condition of the patient will happen on the basis of standardized~     questionnaires. Based on the results of these questionnaires, collected at different times,~     we can determine which treatment provides the best rehabilitation after meniscectomy. The~     first (preoperative) questionnaire, given at registration of the operation, is completed and~     given to the nurse of the day hospital on the day of surgery, the other (postoperative)~     questionnaires are sent electronically to the patient's email address and need to be~     returned, after filling up.~      This study spends specific attention to the speed of resumption of work / sports and daily~     activities and the presence or absence of complaints.~   "
152434|NCT01571089|"~     The main interest in this study is to investigate if it is possible to use strategies from~     Dialectical Behavior Therapy (DBT) to increase effectiveness of ordinary Cognitive Behavioral~     Therapy (CBT) for patients with anxiety disorders. For the patients included in this study,~     previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of~     positive results after treatment).~   "
152435|NCT01571076|"~     Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal~     embryos before the transfer in IVF treatments in many cases. There is great debate in the~     scientific community as to whether this is an efficient practice in patients of different~     prognosis.~      This prospective and randomized study seeks to study the results of chromosomal diagnosis~     using the new Comparative Genomic hybridization (CGH) arrays technique by practicing~     Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not~     on the other arm in order to compare the results. The investigators will study the ongoing~     pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos~     (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two~     different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male~     severe factor (≥2 million spermatozoids/ml.).~   "
152436|NCT01571063|"~     Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to~     biochemical and histological parameters.~        -  Trial with medicinal product~   "
152437|NCT01571050|"~     The risk of dental fluorosis development is related to the systemic exposure to fluoride~     during enamel formation. Currently, diet and fluoride toothpastes are the main sources of~     fluoride to children at the age-risk for fluorosis development. However, when estimating the~     risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the~     systemic fluoride bioavailability. Since some toothpaste formulations may contain part of~     fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride~     in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult~     volunteers will ingest a standardized dose of total fluoride from commercially available~     toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic~     bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after~     ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.~   "
152438|NCT01571037|"~     Right ventricular (RV) failure occurs in an estimated 5-41% of cases involving left~     ventricular assist device (LVAD) implantation and has been shown to adversely affect~     peri-operative morbidity and mortality. Current therapies to improve RV dysfunction pre and~     post-operatively are limited. Inhaled milrinone has been shown in several small human studies~     to be safely tolerated and provide favorable effects on pulmonary hemodynamics.~      Study Hypothesis: Delivery of inhaled milrinone, a phosphodiesterase III inhibitor, may~     provide pulmonary artery vasodilation and therefore improved RV function in patients with end~     stage heart failure receiving HeartMate II LVAD as a bridge to cardiac transplantation or as~     destination therapy.~      Specifically, we aim to:~        -  demonstrate safety of inhaled milrinone in this patient cohort~        -  demonstrate efficacy of inhaled milrinone in this patient cohort~   "
152439|NCT01571024|"~     The purpose of this study is to establish the safety and tolerability of BKM120 when combined~     with mFOLFOX6 and to define the maximum tolerated dose of BKM120 in this combination in~     advanced solid tumors including metastatic pancreatic cancer.~   "
152440|NCT01571011|"~     The purpose of the study is to determine whether a culturally tailored, low-cost, primary~     care/internet based depression prevention intervention (CURB) is superior to wait-list~     control for African American and Hispanic youth in terms of depression-related outcomes. It~     is hypothesized that compared to teens in the wait-list control condition, teens in the CURB~     program will exhibit lower levels of depressed mood and/or more rapid changes in mood during~     the follow-up time.~   "
152443|NCT01570972|"~     Multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT] are~     evidence-based treatments for first episode psychosis. However, like all treatments for~     psychotic disorders, neither MFG nor GCBT are perfect—some individuals who receive these~     interventions still experience a worsening of psychotic symptoms. Clarifying the mechanisms~     through which these interventions produce their clinical benefits and identifying the factors~     that may maximize an individual's response to MFG and GCBT could improve the clinical~     benefits facilitated by these two interventions.~   "
152444|NCT01570959|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.~   "
152445|NCT01570946|"~     Primary prevention of diabetes is of paramount importance in both developed and in developing~     countries. Several studies including the Indian Diabetes Prevention Programmes have shown~     that Lifestyle modification in people with prediabetes can reduce the progression to diabetes~     by 58%. However, there are two main problems in applying diabetes prevention strategies to~     the population as a whole. (1) Trial based interventions are unrealistic on a population~     level in any country. (2) The oral glucose tolerance test applied so far to identify those at~     high risk is a poorly reproducible and time consuming test both for the participant and for~     health care workers. Hence more practical means of defining individuals who would benefit~     from lifestyle intervention are required.~      The current study proposes a prevention strategy that will employ a lifestyle modification~     programme delivered by text messaging in both India and the UK.Subjects will be identified~     based on the HbA1c measurement instead of the oral glucose tolerance test. The study will~     also assess the efficacy, acceptability and cost effectiveness of mobile phone based~     intervention both in India and the UK.~      Messages will be based to deliver education, treatment targets, advice, support and~     motivation. Subjects will be invited to participate and, once recruited, will be randomised~     to usual care or the SMS intervention group.~      Usual care will consist of a one-to-one 30 minute interview, conducted by the research team,~     delivering personalised diet and exercise advice.~      The intervention group will undergo the same initial interview and, in addition, will receive~     3 times weekly text messaging with education, advice, support and motivation. These messages~     will be personalised to individual targets set at the initial interview.~      Primary Outcome:Progression to Diabetes Secondary Outcomes will be based on Physical activity~     / Cardiovascular risk factors/and quality of life.~      The study programme is compatible with major initiatives in both the UK and India for the~     prevention of diabetes and cardiovascular disease (CVD).~   "
152446|NCT01570933|"~     Neonates who underwent cardiac surgery with cardiopulmonary bypass almost always require~     non-invasive respiratory support (NIV) in relay to conventional ventilation. Current nasal~     interfaces do not generally allow synchronised bilevel ventilation. NIV-NAVA mode allows,~     through an oesophageal catheter, to record the electrical activity of the diaphragm and~     thereby synchronize breaths from the ventilator on the inspiratory efforts of the child.~     Moreover, the pressure support delivered by the ventilator may be proportional to the~     diaphragmatic effort developed by the child. This mode, associated with the interface~     Miniflow®, could increase the comfort of the child by allowing a more efficient~     synchronization and reducing its respiratory work. To our knowledge, this ventilation mode~     with this interface has not been evaluated in the postoperative period of cardiac surgery in~     the newborns. The purpose of this study is to evaluate the feasibility of this ventilatory~     mode and evaluate its influence on ventilatory parameters of this category of infants.~   "
152447|NCT01570920|"~     Chronic stroke patients (>6 months) fulfilling including criteria were trained during 3~     months. The physical training program was based on walking.~   "
152448|NCT01570907|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Quetiapine Fumarate 25 mg Tablet under fasted conditions.~   "
152449|NCT01570894|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Quetiapine Fumarate 25 mg Tablet under fed conditions.~   "
152450|NCT01570881|"~     Delirium is common complications in postoperative critically ill patients. However the~     mechanism of postoperative delirium is not well understood.The investigators designed a~     prospective observational study to investigate the association of perioperative plasma~     melatonin levels with postoperative delirium and general anesthesia. The investigators~     included 33 patients required intensive care more than 48 hours after sevoflurane anesthesia~     in an academic tertiary care hospital. The investigators measured plasma melatonin levels 4~     times and assessed postoperative delirium using Confusion Assessment Method for the intensive~     care unit (CAM-ICU).~   "
152451|NCT01570868|"~     The goal of this clinical research study is to learn if ponatinib can help to control Chronic~     Myeloid Leukemia (CML) in accelerated phase. The safety of this drug will also be studied.~      Ponatinib is designed to block the function of BCR-ABL, which is the abnormal protein~     responsible for causing leukemia in certain cells.~      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location~     of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or~     death. A blood clot may occur within 2 weeks after you start taking the drug. About 25% (1 in~     4) of patients taking the drug form an abnormal clot. Blood clots can occur in patients that~     do not have other known risk factors for forming clots. If you develop a blood clot, you will~     need to stop taking ponatinib. In some cases, emergency surgery could be needed to remove the~     clot and restore blood flow.~   "
152452|NCT01570855|"~     The purpose of this study is to screen chemotherapy drugs currently used to treat lung cancer~     and determine the most effective treatment based on results of chemo sensitivity testing on~     the patients own cancer cells in the laboratory. The results of this screening will not~     influence the patients treatment.~   "
152453|NCT01570842|"~     Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity)~     associated with an increase in acidic and non acidic reflux as well as systemic inflammation~     involving esophageal mucosa, thereby increasing esophageal injury and predisposing to~     subsequent development of Barrett's esophagus (BE)?~   "
152454|NCT01570829|"~     -  To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in~          treatment of obese patients (BMI 35,0-39,9 kg/m2).~        -  To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks~          of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).~   "
152455|NCT01570816|"~     The purpose of this research study is to evaluate the effectiveness of functional electrical~     stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and~     ankle function to improve walking in people with partial paralysis.~   "
152467|NCT01570660|"~     Thiazoledinediones decrease blood glucose by their insulin-sensitizing properties. Here the~     investigators examined whether pioglitazone (PIO) improves insulin sensitivity independently~     of glycemic control and whether adipokines or non-esterfied fatty acids (NEFA) serve as~     mediators.~   "
152468|NCT01570647|"~     The purpose of this study is to develop a measure - the needle torque test - capable of~     detecting connective tissue abnormalities associated with musculoskeletal disorders.~   "
152456|NCT01570803|"~     Recent stent design improvements focus on decreasing stent fracture rates which can~     negatively impact patency rates by rearranging strut alignment. Although there have been~     several retrospective or registry studies for atherosclerotic femoropopliteal disease in the~     East, there have been few randomized control trial for comparison of stent fracture and~     primary patency between different nitinol stents. Smart stent has the peak-to-valley bridge~     and in-line interconnection. Medtronics company have claimed Complete's stent crowns have~     been configured to minimize crown to crown interaction, increasing the stent's flexibility~     without compromising radial strength. We made the hypothesis that the design of Complete-SE~     stent might be more fracture-resistant or effective for in-stent restenosis, compared with~     Smart stent. On the other hand, 2011 ESC guideline recommended that dual antiplatelet therapy~     with aspirin and a thienopyridine for at least one month is recommended after infrainguinal~     bare-metal-stent implantation. Recent meta-analysis has shown that the efficacy of cilostazol~     in the atherosclerotic femoropopliteal lesion was proven. However, still specific data~     regarding a variety of antiplatelet regimen are limited. To date, there is no the study for~     comparison between clopidogrel and cilostazole in patient undergone stent implantation in~     femoropopliteal lesion. In conclusion, the purpose of our study is to examine and compare~     Primary patency and stent fracture between different two-nitinol stents (S.M.A.R.T. CONTROL~     versus Complete SE) and to compare binary restenosis rate between clopidogrel and cilostazol~     in femoropopliteal arterial lesion.~   "
152457|NCT01570790|"~     The purpose of the study is assess safety, bioactivity, and maximal tolerated dose of~     repeated weekly intravenous infusion of combretastatin A-4 phosphate (CA4P) in patients with~     neovascular age-related macular degeneration~   "
152458|NCT01570777|"~     The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the~     effectiveness and costs of renal denervation in addition to standardized medical treatment~     compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal~     denervation will be performed using the Symplicity Catheter - a percutaneous system that~     delivers radiofrequency (RF) energy through the luminal surface of the renal artery.~   "
152459|NCT01570764|"~     By including in this study patients with significant worsening of their lung volumes and / or~     their DLCO (carbon monoxide diffusing capacity) in the previous year, on the basis of an open~     retrospective study we recently conducted, we hope to demonstrate that a strategy combining~     prednisone and intravenous cyclophosphamide therapy is accompanied by an increase in the~     frequency stabilization / improvement of lung volumes and / or DLCO of patients at 12 months~     of 15% in the placebo and prednisone cyclophosphamide 50% in cyclophosphamide and~     prednisone.We also hope to demonstrate significant decrease in the number of patients~     excluded for failure in the CYC arm as compared to the placebo arm.~   "
152460|NCT01570751|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in~     controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.~   "
152461|NCT01570738|"~     Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem.~     The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most~     of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in~     the age group of 6 and less and about 1.5% above. The in-lab sleep study using full~     Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep~     Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full~     night PSG, together with long waiting lists for sleep studies, have led to the commonly used~     procedure of split-night for OSAS patients, as well as to the development of a variety of~     ambulatory sleep study systems. The primary study objective is to compare the efficacy of the~     WatchPAT200 (WP200), as an ambulatory device for aiding in the diagnosis of sleep disorders~     for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a gold~     standard.~   "
152462|NCT01570725|"~     Background. Preoperative anxiety is a common problem for patients who undergo surgical~     operations, being often associated with a number of negative behaviours during and after the~     surgical experience. Since drug treatments alone have frequently proved to be inadequate to~     reduce stress and anxiety in surgical contexts, in the last decades there has been an~     increased interest in non invasive complementary and alternative medical therapies (CAM),~     including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension~     during pre and post operative phases. Virtual reality can be considered an innovative form of~     e-health-based CAM therapy having gained recognition as a means of attenuating pain during~     medical procedures. VR reduces distress and pain perception by providing a particularly~     intense form of immersive distraction that taxes the patient's limited attention capacity,~     resulting in the withdrawal of attention from the real, noxious, external stimulus with a~     subsequent reduction in pain and stress.~      Objective. The aim of this study is to test the efficacy of a small, portable and immersive~     virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory~     surgical operations under local or regional anaesthesia.~   "
152463|NCT01570712|"~     As mental health care shifted from state psychiatric hospitals to the community in France and~     western countries, the mental health system became inevitably involved in housing as it~     strove to meet the broader psychosocial needs of consumers. Simultaneously, as many consumers~     found themselves unable to find stable living in the community and struggling with~     addictions, they became a significant subgroup within a larger homeless population, which has~     received increasing policy attention over the past three decades. There are two distinct~     service models for adults who have severe mental illness and are homeless: the residential~     continuum model and the Housing First model.~   "
152464|NCT01570699|"~     The main objective is to compare the genotypes of the COMT Val158Met polymorphism between~     opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample~     of opiate-users without any lifetime opiate dependence.~   "
152465|NCT01570686|"~     The purpose of this study is to evaluate the effect of food on aliskiren's efficacy,~     pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light~     meal versus fasted conditions.~   "
152466|NCT01570673|"~     What are we doing? A pilot research study is planned to take place within the Pediatric~     Urology program at McMaster Children's hospital starting this spring/summer 2012. The pilot~     study will compare standard individual teaching that occurs in pediatric urology clinic about~     bladder re-training and achieving healthy bladder and bowel habits to a group teaching~     session. The group teaching session will be one hour in length and include the same content~     taught in pediatric urology clinic and provide more time for the children to ask questions,~     demonstrate and practice different exercises and talk about some of the challenges associated~     with having problems with their bladder. The group teaching session will be approximately one~     hour in length and occur weekly in the evenings for 12 to 15 weeks. Study participants will~     be asked to attend either one group teaching session or one individual teaching session which~     will occur in regular pediatric urology clinic. Parents will be asked to complete a~     demographics questionnaire at the start of the study and child participants will be asked to~     complete 2 short questionnaires about symptoms and quality of life before and after either~     individual or group teaching sessions. At the 3 month follow up, parents and child~     participants will also be asked to fill out an evaluation form of the session received.~     Children between the ages of 6 and 10 years old and a diagnosis of nonneurogenic lower~     urinary tract dysfunction will be asked if they would like to participate.~      Why are we doing it? Some of the symptoms of bladder dysfunction include incontinence~     (wetting), recurrent urinary tract infections, frequency (having to pee a lot) and urgency~     (having sudden urges to pee). These symptoms can affect a child's physical and~     emotional/mental well-being. Treatment includes improving bladder habits through bladder~     re-training and improving bowel habits through treatment and management of constipation as~     well as establishing a bowel routine. Children are taught about their urinary tract system~     and what they need to do to improve and maintain its health. Children are asked to void (pee)~     every 2 hours, double void and drink more water. Sometimes they also need to take~     medications. Often in a busy clinic, parents are taught what the child needs to do and~     expected to return home and implement the bladder re-training instructions. Participation of~     the child during these visits varies. However, participation and engagement of the child in~     bladder re-training is crucial for success. Also, little time is spent on the impact of~     bladder dysfunction on the lives of these children. Many children do not want to follow the~     instructions on bladder re-training because they are worried about what their peers may say.~      What do we hope to accomplish? The purpose of this study is to assess the feasibility of a~     group teaching session and evaluate the preliminary effectiveness of the session.~     Questionnaire results will be compared before and after the teaching sessions and between the~     individual and group teaching groups. Evaluation forms will provide feedback about the~     teaching sessions which will help determine the strengths of the sessions and improvements~     that could be made to improve the quality and effectiveness of future treatment. Outcomes~     that will be measured include symptoms and quality of life. This pilot study will also~     provide important information related to symptoms and quality of life for these children.~   "
153960|NCT01551095|"~     This research is being done to study the safety of an investigational percutaneous endoscopic~     gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube~     prevents it from slipping back into the stomach.~   "
152469|NCT01570634|"~     Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to~     life-threatening colitis. Illness from C. difficile most commonly affects patients in~     hospitals and long-term care facilities and typically occurs after a patient has received~     antibiotics.~      In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to~     bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity~     of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would~     likely occur in conjunction with neutralization of C. difficile toxins A&B by CASAD. Computer~     modeling of CASAD performed by Phillips et al. at Texas A&M University supports this~     hypothesis.~      The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care~     therapy will reduce the duration and severity of diarrhea and other symptoms in patients with~     C. difficile infection.~   "
152470|NCT01570621|"~     Achalasia is a rare esophageal motility disorder, characterized by incomplete lower~     esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and~     aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and~     chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin~     injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral~     endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal~     invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM~     in our department, and to assess short-term and long-term efficacy of POEM by using Stooler~     score, Echardt score, esophageal barium and manometry.~   "
152471|NCT01570608|"~     Ranibizumab has been proven to be effective in large multicentre studies. However, the~     injections have to be repeated monthly. A combined therapy with the established photodynamic~     therapy might even be more effective, less intravitreal injections might be necessary due to~     a synergistic effect.~      The study will be conducted to explore whether intravitreal ranibizumab in monotherapy or in~     combination with verteporfin photodynamic therapy under a new time regime is an effective,~     safe and convenient treatment for patients with subfoveal Choroidal Neovascularisation (CNV)~     secondary to Age-Related Macular Degeneration (AMD).~   "
152472|NCT01570595|"~     The purpose of this study is to evaluate the first web-based cessation program developed~     expressly for people living with HIV who smoke tobacco. Main study goals are (1) to evaluate~     the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) and (2)~     to complete a prospective, randomized controlled trial comparing the efficacy of the online~     program to standard care with a primary outcome of 3 month point-prevalence abstinence.~   "
152473|NCT01570582|"~     purpose Primary endpoint~        -  To evaluate the 24 month disease free survival Second endpoints~        -  To evaluate the 24 month overall survival To analyze the toxicity and the quality of~          life~   "
152474|NCT01570569|"~     The investigators objectives were developing mini dose five-drug cocktail regimen to evaluate~     potential drug-drug interactions associated with use of a cocktail of caffeine, losartan,~     omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9,~     CYP2C19, CYP2D6, and CYP3A activities.~   "
152475|NCT01570556|"~     When considering occult infections during the diagnostic workup of inflammation in~     Hemodialysis (HD) patients, the urine-deprived bladder is frequently dismissed as potential~     site of infection. The urinary tract, even in end stage renal disease (ESRD) patients on~     hemodialysis may represent a significant reservoir for infection. Delayed diagnosis is a~     relevant issue because the urinary tract is often overlooked as a source of infection in~     dialysis patients, especially because of absence of urinary tract infection (UTI) symptoms in~     HD patients. Contributing factors to asymptomatic UTI in HD patients include the presence of~     low urine volume, bladder stasis, and the fact that UTI symptoms are mostly related to~     voiding, which is reduced or absent in these patients. Persistence of asymptomatic~     bacteriuria and UTI may be related to higher levels of inflammatory markers in HD population.~     In view of the association between cardiovascular disease and cardio-vascular and all-cause~     mortality with inflammation, as expressed by elevated CRP and/or IL-6 levels in HD patients,~     the investigators questioned whether presence of asymptomatic UTI could contribute to~     elevated levels of inflammatory markers in patients with ESRD on maintenance HD therapy. Such~     a finding would provide a potential link between a treatable infection and a potential~     cardiovascular risk factor in this population.~   "
152476|NCT01570543|"~     The purpose of the study is to improve image quality, increase speed of scanning and to see~     how well certain products test by scanning people who have an orthopedic hip or knee metallic~     implant.~   "
152477|NCT01570530|"~     The purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both~     during preoperative and postoperative period), as prophylaxis against postoperative atrial~     fibrillation after cardiac surgery, in a valve disease patient population (with or without~     associated coronary artery disease), with no previous history of atrial fibrillation and not~     receiving beta-blocking drugs.~   "
152478|NCT01570517|"~     The purpose of this study is to evaluate the safety and potential benefits of the interatrial~     septal defect (IASD) System in patients with heart failure with preserved ejection fraction.~   "
152479|NCT01570504|"~     Ivermectin is currently the best drug to cure strongyloidiasis, but the standard single~     dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal~     in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the~     parasite.~      Aim of this study is to define the most effective dose schedule of ivermectin to cure~     strongyloidiasis.~   "
152498|NCT01570257|"~     In treating idiopathic normal pressure hydrocephalus with a shunt there is always a risk of~     underdrainage or overdrainage. The hypothesis is tested whether treatment of patients with an~     adjustable valve preset at the highest opening pressure (OPV), leads to comparable clinical~     results with less subdural effusions than in a control group with an opening pressure preset~     and kept fixed at a low pressure level.~   "
152499|NCT01570244|"~     This study will investigate possible effect of multiple oral doses of BI 201335 on the steady~     state pharmacokinetics of ethinylestradiol and levonogestrel~   "
152500|NCT01570231|"~     Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the~     heart. This study aims to evaluate the feasibility, safety and initial efficacy of using~     briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in~     octogenarians with symptomatic intracranial arterial stenosis.~   "
152480|NCT01570491|"~     No sample size estimation methodology currently exists for the right-censored count data~     models. We expect less number of attempts in the ultrasound group a 20 % difference between~     the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level~     of significance with a power of 0.8, we will require a minimum of 20 patients per~     group,therefore we plan to recruit 40 patients in total. Patients who consent to receive~     spinal anesthesia (as opposed to some other anesthetic technique) and who meet the~     inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery~     after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia~     technique. A block randomization scheme with random block sizes ranging from 2-8 patients~     will be used. The outcomes will be recorded by a third party observer in the block~     room/operating room who might be a nurse or resident or clinical research fellow not directly~     involved with performing the block. The post procedure outcomes will also be recorded by a~     clinical research fellow or resident who was not directly involved with performing the block.~     The analysis will be conducted by a statistician who will be blinded.~   "
152481|NCT01570478|"~     The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler®~     100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation~     b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in~     post-dose peripheral airway resistance) in patients with asthma.~   "
152482|NCT01570465|"~     All patients receiving induction, consolidation and salvage chemotherapy, and autologous or~     allogeneic stem cell transplantation according to a strategy defined in the GIMEMA AML1310~     protocol will be prospectively monitored for SI (bacteremia, invasive mycoses, other~     microbiologically documented bacterial infections, pneumonia, other invasive tissue~     infections and viral diseases) during each chemotherapy and transplant and the impact of~     these infections on survival will be evaluated until 24 months from the diagnosis of AML.~   "
152483|NCT01570452|"~     Matrix metalloproteinases (MMPs) have been shown to be involved in cancer biology.~     Significant expression of MMP-7 (matrilysin) in colorectal cancer is mainly associated with~     metastatic disease even though it is expressed in most tumor states. Our purpose is to~     analyse MMP-7 in bowel and lymph nodes of different tumor stages and to evaluate its~     expression as a potential biomarker of cancer disease in patients surgically treated for~     benign and malignant colorectal tumors. Tumoral tissue, lymph nodes and serum samples from~     recruited Patients plus serum samples from healthy volunteers are analysed for matrilysin~     expression by histology, immunohistochemistry, ELISA and Western blotting.~      If Matrilysin increases with increasing dysplasia and cancer disease stage in tumor tissue as~     well as in the regional lymph nodes it might be used as a complement in investigating~     suspected locally advanced cancer.~   "
152484|NCT01570439|"~     Aim: To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens~     (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore.~      Methods: The panel of candidate peptides are synthesized and tested for their ability to~     induce peptide-specific CTL responses, in order to screen the peptide epitopes applicable for~     the cancer vaccination. Briefly, peripheral blood lymphocytes (PBLs) derived from~     HLA-A1101(+) healthy donors are taken and cultured in the presence of the each candidate~     peptide with recombinant IL-2 for 2 weeks, and then, re-stimulated with dendritic cell pulsed~     with the peptide following another 2 week culture. Thereafter, CD8(+) T lymphocytes were~     negatively selected with CD4-magnetic beads from cultured lymphocytes and tested for their~     peptide specificity employing enzyme-linked immunospot (ELISPOT) assay. These conditions are~     completely performed in in-vitro system. Importance in medicine: If one could identify the~     peptide epitopes from novel Oncoantigens, it is applicable for clinical trials of cancer~     vaccination.~      Benefits & Risks : There is no risk except for the matter of venipuncture in each~     individuals.~      The ideal target molecules for cancer vaccination are thought to be selectively expressed in~     tumor cells, but not in the normal cells, with high frequent and homogenous expression within~     tumor. We have proved that novel Oncoantigens, URLC10, KIF20A and CDCA1, have these~     characters as ideal target molecules for the cancer vaccination and are highly expressed in a~     variety of tumor type such as gastric, lung, and pancreas cancer. Since HLA-A1101 haplotype~     is most frequent in Singaporean, it is essential to indentify the HLA-A1101-restriced~     peptides derived from these Oncoantigens to develop cancer vaccination.~   "
152485|NCT01570426|"~     The purpose of this research is to learn more about how children with mental health problems,~     including bipolar disorder (BD), attention deficit hyperactivity disorder (ADHD), and~     generalized anxiety disorder (GAD), differ from children without these problems. The~     investigators want to understand how these 4 groups of children differ in brain activity,~     function, and structure.~   "
152486|NCT01570413|"~     This study is designed to determine whether the pelvic examination (including bimanual and~     speculum examination) is necessary in patients with first trimester vaginal bleeding/ lower~     abdominal pain when an intra-uterine pregnancy (IUP) is seen on ultrasound. Patients with the~     chief complaint of vaginal bleeding or lower abdominal pain less than 16 weeks and positive~     HCG will be considered for this non-inferiority-designed clinical trial. All patients who~     present to the BMC Emergency Department (ED) Mon - Fri from 8am to 11pm and have had serum or~     urine HCG testing and a formal ultrasound by a credentialed emergency physician or radiology~     technician as part of standard of care will be screened for further eligibility. Those~     patients with intra-uterine pregnancies < 16 weeks gestation seen on ultrasound and meet~     inclusion criteria will then be asked to provide informed consent to participate in the~     study. Randomization will occur after consent has been obtained. Half of the patients will be~     randomized to receive pelvic examinations and the other half will not. Further care will be~     determined by the treating attending physician. The primary outcome will be a composite~     morbidity endpoint at 30 days, including return visits to the ED, emergency surgery, need for~     transfusion, infection, or other missed source of bleeding/ pain. Secondary outcomes of~     interest include ED throughput time, and patient satisfaction.~   "
152487|NCT01570400|"~     The purpose of this study is to determine whether an internet-based treatment program,~     consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces~     symptoms of social phobia among a population diagnosed with this disorder.~   "
152501|NCT01570218|"~     OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer~     in patients with breast's or gynecology's cancer, during the radiotherapy treatment.~   "
152488|NCT01570387|"~     This study seeks to enroll patients with AL amyloidosis, for whom treatment with one of the~     standard melphalan chemotherapy-based regimens is either not recommended or is not their~     preference.~      Pomalidomide (CC-4047) is a drug given by mouth, which can change or regulate the functioning~     of the immune system. So, in theory, it may reduce or prevent the production of the amyloid~     protein. Pomalidomide is not currently FDA-approved for AL Amyloidosis. Pomalidomide is~     chemically similar to thalidomide and lenalidomide, both of these drugs have been approved by~     the FDA for treatment of patients with multiple myeloma (MM), a disease similar to AL~     Amyloidosis.~      Participants in this study will receive pomalidomide and dexamethasone. Phase I is a~     dose-escalation study and dose escalation will proceed through 3 dose-levels according to~     standard rules in which dose levels are started sequentially after complete evaluation of the~     occurrence of dose-limiting toxicities. In the Phase II portion, participants will receive~     pomalidomide and dexamethasone using the defined maximum tolerated dose.~   "
152489|NCT01570374|"~     The purpose of this study is to determine whether internet-administered cognitive behavior~     therapy is a feasible treatment for generalized anxiety disorder.~   "
152490|NCT01570361|"~     The objective of this study is to determine whether early radiofrequency (RF) ablation~     treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including~     THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation~     (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate~     or rhythm control) using current AF management guidelines.~   "
152491|NCT01570348|"~     This phase II trial studies how well giving a donor bone marrow transplant (BMT) works in~     treating patients with refractory Crohn's Disease. We will select patients with severe~     Crohn's Disease and active inflammation despite the best medical and surgical treatments.~     These patients must be healthy enough to undergo a transplantation procedure. They cannot~     have an active infection, and their heart, lungs, kidneys, and liver cannot be failing. The~     transplant procedure starts with chemotherapy and a small dose of radiation, to weaken a~     patient's immune system so that it will accept bone marrow cells from another person. After~     that other person's bone marrow cells are given to the patient, immune suppressive medicines~     are given to prevent the new cells from being rejected and to stop those cells from damaging~     the patient. After the new donor cells start to work, blood counts will rise and the new~     immune system will start to grow. During this time, there is a risk of infection. Antibiotics~     and anti-viral drugs will be given to prevent infection. When the new donor cells are~     well-established, immune suppressive medicines are discontinued. We will examine parts of the~     intestine that were inflamed before the start of the transplant procedure, to be sure the~     Crohn's Disease has disappeared after the transplant. Patients will be formally evaluated for~     Crohn's activity at around 100 days after transplant, and yearly after that for 5 years.~   "
152492|NCT01570335|"~     The aim of this study is to analyze the impact of SBAR by the SAQ questionnaire in the~     perinatal department.~   "
152493|NCT01570322|"~     Study the factors that explain Health-Related Quality of Life (HRQL) in patients with~     Alzheimer disease including:~        -  The influence of the environment (physical and human) on Health-Related Quality of Life~          (HRQL),~        -  The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL),~        -  The influence of formal and informal help mobilized,~        -  The influence of interactions patient - caregiver on Health-Related Quality of Life~          (HRQL),~        -  The influence of the ratio necessary cost on available resources on Health-Related~          Quality of Life (HRQL)~   "
152494|NCT01570309|"~     Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular~     disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and~     prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living~     populations in the United States especially in urban, and multi-ethnic low income Northern~     cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk~     and evaluate outcomes have not been performed.~      The investigators propose a double-blind, randomized wait-list control trial in subjects with~     Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is~     to measure endothelial function using reactive hyperemia peripheral arterial tonometry~     (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to~     measure levels of inflammation before and after treatment with Vit D replacement therapy.~     These aims will test the hypotheses that Vit D repletion will improve endothelial function~     and reduce the levels of detectable inflammation in the plasma of these subjects.~   "
152495|NCT01570296|"~     The safety, tolerability and recommended phase 2 dose (RP2D) of the combination of gefitinib~     and BKM120 will be determined.~   "
152496|NCT01570283|"~     The subjects eligible for this trial have a type of blood cell cancer, other blood disease or~     a genetic disease for which they will receive a stem cell transplant. The donor of the stem~     cells will be either the subject's brother or sister, or another relative, or a closely~     matched unrelated donor. The Investigators are asking subjects to participate in this study~     which tests if blood cells from the subject's donor that have been grown in a special way,~     can prevent or be a effective treatment for early infection by five viruses - Epstein Barr~     virus (EBV), cytomegalovirus (CMV), adenovirus, BK virus (BKV) and human herpes virus 6~     (HHV6).~      The Investigators have grown T cells from the subject's stem cell donor in the laboratory in~     a way that will train them to recognize the viruses and control them when the T cells are~     given after a transplant. This treatment with specially trained T cells (also called~     cytotoxic T cells or CTLs) has had activity against three of these viruses (CMV, EBV and~     Adenovirus) in previous studies. In this study the Investigators want to see if they increase~     the number of viruses that can be targeted to include BKV and HHV6 using a simple and fast~     approach to make the cells.~      The Investigators want to see if they can use a kind of white blood cell called T lymphocytes~     (or T cells) to prevent and treat adenovirus, CMV, EBV, BKV and HHV6 in the early stages of~     reactivation or infection.~   "
152497|NCT01570270|"~     In this study the investigators aimed at verifying whether consumption of a sheep cheese,~     naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic~     acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild~     hypercholesterolemic subjects.~   "
161207|NCT01455922|"~     Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to~     metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.~   "
152503|NCT01570192|"~     The primary objective of this study is to demonstrate a low rate of emergence of antibiotic~     resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized~     patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem~     administered as a prolonged infusion in combination with a parenteral aminoglycoside plus~     tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 -~     control arm).~   "
152504|NCT01570179|"~     Should the dose of sugammadex in morbid obese patients be calculated on the real body weight~     or the ideal body weight?~      The main objective of the trial is to compare in patients undergoing bariatric surgery the~     efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on~     real body weight (control intervention) with dosing based on ideal body weight (experimental~     intervention). The research hypothesis is that both dosing regimens are equivalent~      The secondary objective of the trial is to compare the impact of the depth of neuromuscular~     blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very~     deep block (TOF count = 0 and PTC < 5)~   "
152505|NCT01570166|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial~     hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence~     of HCC after partial hepatectomy is common and was reported to be more than 77% within 5~     years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC~     recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after~     initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a~     small proportion of patients with HCC recurrence (10.4-31%), either because of the poor~     functional liver reserve or because of widespread intrahepatic recurrence. In the past two~     decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality~     and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0~     cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year~     survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is~     particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors~     are usually detected when they are small and PRFA causes the least deterioration of liver~     function in the patients. To the best of our knowledge, there has been no report published in~     the medical literature comparing the efficacy of repeat hepatectomy with PRFA for recurrent~     HCC. The aim of this retrospective study is to compare the outcome of repeat hepatectomy with~     PRFA for small recurrent HCC after partial hepatectomy.~   "
152506|NCT01570153|"~     The purpose of this study is to evaluate the ability of a non-invasive monitor that measures~     how much fluid is in the body as well as various blood tests for their ability to predict~     worsening kidney function in patients with heart failure.~   "
152507|NCT01570140|"~     Rationale: Accounting for the growth, aging and detrimental life style changes in the Dutch~     population, the investigators expect further growth of number of known diabetes patients. The~     economic burden with this increase will be enormous, the healthcare system is under~     increasing pressure to provide better but more time efficient service to more people with~     limited human resources. the investigators hypothesize that, by increasing the patients~     self-management by offering remote care services, this reduction of the individual caseload~     can be achieved.~      Objective: Primary objective is to test the hypothesis that the consistent use of a web~     portal and its educational content and the possibility to review personal diabetes related~     data for type 2 diabetes patients (T2DM) in the primary care setting, will result in an~     improvement quality of life.~      Study design and methods: In this Prospective observational cohort study the investigators~     examine the effect of the voluntarily use of a web portal and its educational content. The~     primary end point is health related quality of life. We predefined a clinically relevant~     difference of 0.074 in the EQ-5D index score. Secondary endpoints are diabetes-related~     distress and well being and a selection of clinical measurements, number of contacts with~     health care provider and the amount of prescribed medication. The participants are being~     followed for 1-year and the data will be collected at baseline, after 6 months and 12 months.~   "
152508|NCT01570127|"~     The purpose of this study is to determine whether acupuncture treatment(Individualized &~     Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment)~     and also whether individualized acupuncture is more effective than standardized acupuncture.~   "
152509|NCT01570114|"~     Self-expanding metallic stent placement is a safe and effective endoscopic procedure~     increasingly used to relieve colonic obstruction. Fully covered metal stents (FCSEMS) and~     plastic stents have been recently developed to reduce both hyperplastic (non tumoral) and~     tumoral tissue ingrowth. These fully covered metal or plastic stents have several advantages~     over non-covered stents, including the possibility of retrieval and limited local tissue~     reaction, while providing alleviation of obstruction at possibly lower costs. Only few~     reports of fully covered metal stent placement in patients with benign colorectal strictures~     are available in the literature. The aim of this study was to assess the effectiveness of~     FCSEMS in the management of the colonic benign strictures.~   "
152510|NCT01570101|"~     The primary objective for this clinical study is to assess the role of the CE Marked Sapheon~     Closure System in closure of incompetent great saphenous veins GSV in a routine clinical~     setting.~   "
152511|NCT01570088|"~     Folic acid is the synthetic form of vitamin folate. Because of its high stability and~     bioavailability, it is the form of folate added to bread in Canada to reduce birth defects.~     There are health concerns about long-term folic acid consumption. Another form of folate,~     L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these~     health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the investigators~     have developed a method to stabilize L-5-MTHF in food. The investigators plan to conduct a~     randomized trial to compare the bioavailability of bread fortified with L-5-MTHF versus folic~     acid.~      The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell~     folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.~   "
152563|NCT01569412|"~     Patients with HER2/neu expressing solid tumors progressing after standard therapy will be~     treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this~     trial is to find the maximum tolerated dose. Tolerability and Safety will be assessed as well~     as efficacy.~   "
161208|NCT01455909|"~     Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin~     monotherapy in patients with type 2 diabetes.~   "
152512|NCT01570075|"~     Hepatocellular carcinoma (HCC) is a common cancer, and it is the third commonest global cause~     of cancer-related death. With an increase in life-expectancy of the general population, the~     number of elderly with HCC is expected to increase. Current curative treatment options for~     HCC include: liver transplantation, liver resection (LR) and local ablation therapy. Liver~     transplantation is a good treatment for HCC within the Milan criteria (single HCC ≤ 5 cm or~     up to 3 nodules each < 3 cm). As a consequence of the lack of liver donors, one relative~     contraindication for liver transplantation is age over 65 years, or the protocol requires~     elderly patients to have very good general health before they can be put on a transplant~     list. Transcatheter arterial chemoembolization (TACE) is used more commonly for the treatment~     of intermediate and advanced-staged HCC, while liver resection and local ablation therapy are~     used for early-staged HCC. Amongst the local ablative therapies, radiofrequency ablation~     (RFA) is most widely used. It has the advantage of minimally invasiveness, making it the~     first-line treatment for small HCC in patients with compromised liver function or associated~     severe medical conditions.~      Elderly patients are more likely to have poor general conditions and associated medical~     diseases. RFA has the advantage of being less invasive and it causes less pain, less blood~     loss and earlier recovery than LR. On the other hand, incomplete ablation of HCC and tumor~     track seeding may happen. Several studies have demonstrated the safety of LR for elderly~     patients. There is no good evidence in the medical literature to support whether RFA or LR is~     a better treatment for elderly patients with HCC.~   "
152513|NCT01570062|"~     This study is focused on the effects of HEPA filtration to reduce exposures to~     combustion-derived air pollution (CDAP). Specifically, the study will evaluate the health~     benefits of HEPA filters and compare the cardiovascular toxicity of two major sources of~     CDAP, specifically traffic and residential wood combustion.~      Specifically, the purpose of this study is to evaluate the ability of portable high~     efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and air pollution indoors~     and to improve subclinical indicators of microvascular function and systemic inflammation~     among healthy adult participants.~      The investigators hypothesize that HEPA filter use will help decrease indoor concentrations~     of CDAP thereby helping to mitigate the associated cardiovascular risks.~   "
152514|NCT01570049|"~     The purpose of this study is to determine whether bendamustine HCl for injection is safe and~     effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.~   "
152515|NCT01570036|"~     The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled~     Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte macrophage-colony~     stimulating factor) (GM-CSF) versus Herceptin + GM-CSF alone. The target study population is~     node-positive (NP) (or node-negative [NN] if negative for both ER and PR) breast cancer~     patients with HER2 1+ and 2+ expressing tumors who are disease-free after standard of care~     therapy. Disease-free subjects after standard of care multi-modality therapy will be screened~     and HLA-typed. E75 is a CD8-eliciting peptide vaccine that was restricted to HLA-A2+ or~     HLA-A3+ patients (approximately two-thirds of the US population), and has been extended to~     HLA-A24+ and HLA-A26+ as well.~   "
152516|NCT01570023|"~     This study is a multisite, randomized clinical trial to determine the effectiveness of an~     8-week rehabilitative exercise regime performed by patients with swallowing problems, termed~     dysphagia, compared to a control group of patients with swallowing problems who do not~     exercise, but receive standard clinical care. One hundred male and female patients will take~     part in this study from eight participating facilities around the country.~   "
152517|NCT01570010|"~     The aim of this study to examine whether an intensive dietary intervention affects health~     measures and development of lifestyle diseases in colorectal cancer survivors.~   "
152518|NCT01569997|"~     Introduction: Epidemiological data show that in France only half of patients with Alzheimer~     disease are currently diagnosed in the general population. The absence of early diagnosis of~     dementia reduces the opportunities of patients to receive optimal care. One of the~     consequences of undiagnosed dementia is inadequate use of emergency care units.~      The main objective: The main aim of this study is to evaluate the impact of a systematic~     case-finding procedure of dementia cases in nursing homes through a MDTM on the rate of~     hospitalization in emergency care units.~      Secondary objectives:~      To assess the impact of systematic tracking of dementia cases on the:~        -  Quantity and quality of drug-prescription~        -  Appropriateness of hospitalizations~        -  Prevalence of neuropsychiatric symptoms~        -  Dependency~        -  Quality of life~        -  Burden of nursing staff working conditions~        -  Planning of specific therapeutic measures~        -  Overall health care costs~   "
152519|NCT01569984|"~     This is a single-centre, single-arm open-label proof-of-concept study to analyze the imaging~     (DCE-CT,CEUS and Quantitative US) effects of neoadjuvant bevacizumab and SBRT on colorectal~     metastases to the liver. Patients will receive 2 doses of bevacizumab 5mg/kg IV prior to~     SBRT. The second dose of bevacizumab will be given 2 weeks after the first dose of~     bevacizumab and within 48 hours of starting the first dose of SBRT. The SBRT prescription~     dose will be up to 60 Gy in 6 fractions, delivered on alternating weekdays for 2 weeks. Total~     SBRT dose will be determined by size of target lesion, liver sparing and organs-at-risk dose~     constraints. DCE-CT, CEUS and Quantitative US will be performed within 7 days prior to the~     first dose of bevacizumab, after the second dose of bevacizumab and within 7 days of~     completing SBRT.~   "
152520|NCT01569971|"~     Sickle cell disease (SCD) is a debilitating genetic disorder affecting 70,000-100,000~     Americans. It is frequently associated with very serious medical complications. For children~     with SCD, successfully transitioning to adult care is a vital step in ensuring continuity of~     care, managing their disease, and improving their health outcomes. Transition programs have~     been created to facilitate the transition process. However, few studies have assessed~     transition readiness and whether transition program components meet the transition needs of~     patients and families.~      The purpose of this study is to explore transitioning from pediatric care to adult care and~     to assess components of the SJCRH SCD Transition Program from three perspectives: adolescents~     with SCD, their caregivers, and young adults with SCD who have transitioned to adult care.~     Data collection methods will include focus groups, questionnaires, and checklists.~     Qualitative data analysis procedures will be used to examine the data.~   "
157003|NCT01511094|"~     The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as a~     first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with~     good vision.~   "
152521|NCT01569958|"~     Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease characterized by~     progressive weakness and muscular atrophy due to the degeneration and loss of motor neurons,~     the nerve cells that, in the central nervous system (motor cortex, brainstem and spinal~     chord), control voluntary movement. Riluzole, the only drug approved for ALS treatment,~     modestly slow disease progression.~      Transcranial direct current stimulation (tDCS) is a noninvasive technique of neuromodulation~     that is currently studied as a possible therapeutic tool for several neurological and~     psychiatric diseases and has been found safe and well tolerated. Based on experimental~     evidence in animals and human subjects, tDCS is expected to reduce motor cortex excitability~     and excitotoxicity, that is neuronal injury induced by excessive glutamatergic stimulation,~     one of postulated pathophysiological mechanisms in ALS.~      This study will investigate if transcranial direct current stimulation of motor cortex is~     useful in delaying disease progression and is well tolerated in ALS patients.~   "
152522|NCT01569945|"~     What is the best medication for hormonal stimulation in cycles with high intra-uterine~     insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days)~     or daily injections with Human Menopausal Gonadotropin (Menopur)?~   "
152523|NCT01569932|"~     This study will document the cognitive (mental) and functional abilities of newly diagnosed~     cancer patients. The study will also examine the changes in cognitive and functional~     abilities during and after chemotherapy (your cancer treatment).~      A comprehensive set of questionnaires and tasks, or assessments, have been put together in~     order for doctors and nurses to learn more about the day to day functioning of newly~     diagnosed adult cancer patients. The investigators would also like to follow up with the same~     adult patients, during and following completion of their cancer treatment, to learn about the~     kinds of treatments they received and how their cognitive status and level of participation~     in activities of daily living has changed. With follow-up assessments, doctors and nurses can~     learn more about the complications or health problems that adult patients may experience as a~     result of undergoing cancer therapy. This is a study involving two visits. The first visit~     occurs within two weeks before starting your cancer therapy, specifically chemotherapy. The~     second visit occurs within two weeks of completing your chemotherapy.~   "
152524|NCT01569919|"~     This study is for patients with malignant mesothelioma of the lung lining (called pleura) who~     are planning to have pemetrexed-cisplatin chemotherapy.~      We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin~     chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This~     vaccine has been used in combination with chemotherapy in other types of cancer and has been~     shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the~     disease, in a similar way to the immune system fighting infection. In laboratory experiments,~     the vaccine has been shown to stimulate an immune response to a particular protein widely~     found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the~     vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4~     protein.~      Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with~     mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the~     combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy~     alone.~      Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The~     TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3~     weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks.~     Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the~     planned trial schedule. We aim to recruit 26 patients into the trial over a two year period.~     If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe~     and beneficial in terms of stimulating the immune system, the combination will be tested~     further in larger clinical trials.~   "
152525|NCT01569906|"~     To assess prospectively, the response of moderate to severe atopic eczema to a standard~     course of narrowband ultraviolet B phototherapy by using validated objective and subjective~     scoring systems.~   "
152526|NCT01569893|"~     To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified,~     centralized and large scale tele-monitoring of blood glucose levels, and whether this~     intervention produces health and economic benefits when introduced without major changes to~     the existing organization of a large treatment care center.~   "
152527|NCT01569880|"~     The purpose of the study is to investigate the relationship between hypoxemia achieved during~     Hypoxia Altitude Simulation test and sea level values of pulmonary function, arterial blood~     gases, pulse oximetry and cardiopulmonary exercise test variables. In addition, to study the~     effect of slow walk in a hypoxic environment, comparable to slow walking along the aisle.~   "
152528|NCT01569867|"~     This study intends to investigate genetic influences on how individuals process statins.~   "
152529|NCT01569854|"~     The study intends to investigate whether genetics influence how individuals respond to~     statins (clinical outcomes and changes in carotid intimal media thickness)~   "
152530|NCT01569841|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare the efficacy of insulin decludec with insulin glargine on glycaemic control using~     continuous glucose monitoring in patients with type 1 diabetes.~   "
152531|NCT01569828|"~     An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and~     its metabolites in subjects with severe renal impairment compared to matched healthy subjects~     with normal renal function~   "
152532|NCT01569815|"~     The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and~     its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety~     of LCZ696 in this population.~   "
152533|NCT01569802|"~     The primary aim of this study is to measure, document and compare recall rates of~     two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D~     mammography in a screening population. This study will compare recall rates for both~     non-cancer and cancer cases.~   "
152564|NCT01569399|"~     Prior research in substance dependence has suggested potential anti-craving effects of~     repetitive transcranial magnetic stimulation (rTMS) when applied to the dorsolateral~     prefrontal cortex (DLPFC). The aim of the investigators study was to investigate the effect~     of high frequency rTMS of the left dorsolateral prefrontal cortex compared to sham~     stimulation on craving and alcohol consumption.~   "
152534|NCT01569789|"~     The autonomic (self-regulating) nervous system is important for the function of many organs~     in the body. The vagus nerve is part of the autonomic nervous system. The vagus nerve carries~     incoming information from the nervous system to the brain, providing information about what~     the body is doing, and it also transmits outgoing information which governs a range of reflex~     responses. It plays an important role in the immune system. A part of the vagus nerve is~     reachable for stimulation at specific locations in the ear.~      The purpose of this study is to better understand how different ways of stimulating the vagus~     nerve at the ear can affect a chemical marker of inflammation found in human blood that is~     associated with a variety of inflammatory diseases such as rheumatoid arthritis and lupus.~     This information may lead to in future studies to see if stimulation of the vagus nerve can~     improve inflammation in chronic inflammatory diseases.~   "
152535|NCT01569776|"~     The primary objective of this clinical trial is to determine whether a new amino acid-based~     formula is hypoallergenic as defined by the American Academy of Pediatrics (2000),~     demonstrating that the test formula does not provoke allergenic activity in 90% of infants or~     children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a~     commercially available hypoallergenic formula.~   "
152536|NCT01569763|"~     The primary objective of this study is to evaluate the safety and effectiveness of the Aurora~     Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in~     reducing menstrual blood loss at 12 months post-treatment.~   "
152537|NCT01569750|"~     The purpose of this study is to identify if, and at what dose, ibrutinib may be administered~     with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and to~     document responses of this combination in patients with newly diagnosed diffuse large B-cell~     lymphoma (DLBCL).~   "
152538|NCT01569737|"~     The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies~     exposed to ella, whether due to failure of the emergency contraception or inadvertent~     exposure during pregnancy.~   "
152539|NCT01569724|"~     Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell~     lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not~     well known. The purpose of this study is to research a carbohydrate metabolism disorder~     associated in bexarotene-induced hypertriglyceridemia.~   "
152540|NCT01569711|"~     Depression is a common, recurrent and disabling disorder. Among patients with a chronic~     course of the disease, 20 to 30% are resistant to antidepressant medications. Among those~     patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients, deep~     brain stimulation (DBS) of nucleus accumbens is considered.~   "
152541|NCT01569698|"~     Limited prospective data is available to compare morbidity and mortality between renal~     replacement modalities in pediatric acute renal failure.~      In the absence of clear standard of care, the choice of the extra renal replacement therapy~     modality is subject to clinical judgement, practical aspects, and costs.~      This study will supply important data about usual modalities of pediatric acute extra renal~     replacement therapy and their impact on patient outcome and renal recovery. An obvious next~     step will be to conduct a randomized controlled trial comparing the different strategies.~   "
152542|NCT01569685|"~     Background: The treatment of traumatised refugees is one of the areas within the field of~     psychiatry with the weakest evidence for the different types of treatment. This is a problem~     for both patients and doctors as well as for society.~      The treatment of choice today for Post Traumatic Stress disorder (PTSD) is antidepressants~     from the subgroup of Selektive Serotonin Reuptake Inhibitors (SSRI), among these the drug~     Sertraline. The evidence for the use of these drugs as treatment for chronically complex PTSD~     in traumatised refugees is however very limited and a large part of the group is estimated to~     be insufficiently treated with this type of medicine. Venlafaxine is an antidepressant from~     the subgroup of dual action product which means that is works on several pathways in the~     brain. Among others it influences the area in the brain that is responsible for the enhanced~     anxiety and hyperarousal experienced by traumatised refugees and which is found to be~     enlarged among patients suffering from PTSD.~      All together there is not sufficient evidence to conclude which type of medical and~     psychological treatment that is most efficient when it comes to the treatment of traumatised~     refugees. Also there is a lack of studies which examines social functioning and the relation~     between psychosocial resources and outcome from treatment. Furthermore there is a lack of~     knowledge of predictors of treatment outcome for the individual patients. This study seeks to~     produce some of this evidence.~      Method: This study is expected to include approximately 150 patients randomised into two~     different groups. The patients are treated with Setraline or Venlafaxine depending on the~     group the randomised to. Patients in both groups are getting the same version of manual based~     Cognitive Behavioural Therapy that is specially adapted to this group of patients. The~     treatment period is 6-7 month. The trial endpoints are PTSD-and depression symptoms and~     social functioning all measured on internationally validated ratings scales.~      Furthermore the study will examine the relation between expected outcome of treatment from a~     range of predictors and the actual treatment results for the individual patient.~      Results: Altogether this study will bring forward new standards for clinical evaluation and~     treatment of traumatised refugees and the results are expected to be used in reference~     programmes/clinical guidelines.~   "
152543|NCT01569672|"~     The Ohio Patient Navigator Research Program (OPNRP) proposes to alleviate disparities in~     relation to the timely diagnosis and treatment of breast, cervical and colorectal cancer in~     Columbus, OH.~   "
152544|NCT01569659|"~     The aim of this study is to compare the efficacy of a flexible high dose of lurasidone to a~     standard dose of lurasidone in patients with treatment resistant schizophrenia or~     schizoaffective disorder. Efficacy of both dosage groups will be measured through testing of~     positive symptoms and other components of psychopathology (negative symptoms, general~     psychopathology, anxiety, depression, cognitive function, global function, severity of~     illness and tolerability). Patients must qualify for treatment resistance after two or more~     antipsychotic drug trials to be included in this trial.~   "
152545|NCT01569646|"~     Increased white blood cell count at the onset of an acute ST elevation myocardial infarction~     has been shown to be associated of increased incidence of heart failure and mortality. Now~     monocytes which are a subset of white blood cells may have a prognostic value for patients~     presenting with acute ST segment elevation myocardial infarction. A monocyte count of greater~     than 800/mm3 following acute myocardial infarction has been shown to be associated with~     increased incidence of left ventricular dysfunction. The investigators study would~     retrospectively collect data on patients with ST elevation myocardial infarction, looking for~     an association between high monocyte count and the culprit vessel causing the myocardial~     infarction. The investigators would also investigate whether monocytosis would be a marker of~     poor prognosis.~   "
152562|NCT01569425|"~     In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin resistance~     and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss is not~     required in lean PCOS patients; nevertheless, the influence of meal timing and composition on~     glucose metabolism and hyperandrogenism may have clinical value. In this study the~     investigators investigate the effects of two isocaloric diets with different meal timing~     distribution on insulin resistance and hyperandrogenism in lean PCOS patients.~   "
152546|NCT01569633|"~     Objective of this study are:~      1) To determine if medication help extreme preterm infants to tolerate feeding better by~     reaching full feeding earlier.2) Out of two medication; which one is better for efficacy 1)~     Erythromycin 2) Metoclopramide. Infants who meet inclusion criteria would be entered to study~     after parental consent. Infant would be blinded to care givers. Infants will be randomized to~     receive one of three medication for 7-14 days. If infants fail on one medication they will be~     allowed to crossover to other medication. Infant would be allowed to treat like other~     infants. Blindness can be broken if deem necessary by attending neonatologist.~   "
152547|NCT01569620|"~     The proposed study seeks to investigate the impact of a culturally targeted print educational~     intervention on rates of colorectal cancer (CRC) screening via colonoscopy among Hispanics.~     If, as expected, the addition of culturally targeted materials to best clinical practices as~     compared to a) best clinical practices plus standard materials or b) best clinical practices~     alone leads to higher rates of CRC screening via colonoscopy then the culturally targeted~     print educational materials can be easily disseminated among this rapidly growing minority~     group who have low rates of CRC screening and whose disease is detected at later, less~     curable stages.~   "
152548|NCT01569607|"~     Stroke is a leading cause of morbidity in the United States but identification of treatment~     strategies to improve outcome is limited by the incomplete understanding of the mechanisms of~     recovery. Motor cortex (M1) reorganization plays a major-role in the recovery of motor~     deficits post-stroke; hence the importance for further development of rehabilitative~     strategies that utilize this potential for recovery.~      In Specific Aim 1, investigators will determine if repeated exposure to training combined~     with Hebbian-type M1 stimulation enhances functional M1 reorganization in lesioned M1 of~     stroke patients.~      In Specific Aim 2, investigators will determine if repeated exposure to training combined~     with Hebbian-type M1 stimulation enhances structural cortical reorganization in lesioned M1~     of stroke patients and to explore whether these structural changes are related to the~     training induced functional cortical reorganization.~      The overall goal of this project is to determine the effect of Hebbian- type stimulation on~     both, functional and structural brain reorganization, thereby obtaining indirect evidence for~     the neuronal substrate underlying training related improvement and maintenance of motor~     function in stroke patients. This knowledge may have a substantial positive impact on~     treatment for stroke patients that may significantly improve recovery and could move the~     field of neuro-rehabilitation forward.~   "
152549|NCT01569594|"~     The objective of this registry is to capture and assess device performance data from subjects~     undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the~     CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry~     provides an ongoing post-market surveillance mechanism to document clinical outcomes on the~     use of the CorMatrix ECM for Carotid Repair.~   "
152550|NCT01569581|"~     Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth~     disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family~     Picornaviridae.~      Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in~     the Asia-Pacific region. Notably, there is evidence that the most severe cases from these~     epidemic outbreaks are associated with neurological disorders with CNS involvement caused by~     EV71 infection. Because of these EV71 infection-related public health issues, the research~     and development of EV71 vaccine candidates have been heavily promoted.~      Recently, several EV71 vaccine candidates have been evaluated in animals but no final results~     of clinical trials, including inactivated vaccine, attenuated vaccine, subunit vaccine, DNA~     vaccine, epitope peptide vaccine, virus-like particles (VLPs).~      Basing on the previous studies of elicited protection in mice and rhesus monkeys, a~     formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA~     in China, Dec. 2010. The phase I clinical and phase II trials were completed, in Guangxi~     Province, China. The results of these clinical trials showed that this vaccine was safe and~     could induce effective antibodies for the infants. The purpose of phase III is to evaluate~     the protected and efficacy of the formalin-inactivated EV71 vaccine in Chinese infants and~     children (from 6 to 71 months old).~   "
152551|NCT01569568|"~     The purpose of this study is to use various types of MRI and cognitive testing to evaluate~     changes in the brain and cognitive function that occur in subjects with ornithine~     transcarbamylase deficiency (OTCD) relative to healthy individuals~   "
152552|NCT01569555|"~     By determining the correlation of a Crossed Leg Sign with signifcant pathology, a clinician~     would then be able to use this correlation to risk stratify his/her patients for significant~     pathology.~   "
152553|NCT01569542|"~     By determining the correlation of a Crossed Leg Sign with significant pathology, a clinician~     would then be able to use this correlation to risk stratify his/her patients for significant~     pathology.~   "
152554|NCT01569529|"~     The purpose of this study is to determine whether tailored online advertisements will drive~     young adult smoker's (18 to 26 years old), who are motivated to quit, to use Internet-based~     cessation treatment.~   "
152555|NCT01569516|"~     The main purpose of this study is to evaluate the safety and efficacy of~     Octohydroaminoacridine Succinate tablets and find the optimal dose in patients with mild to~     moderate Alzheimer's Disease.~   "
152556|NCT01569503|"~     The purpose of this study is to determine whether (VNS) Vagus Nerve Stimulation , is~     effective in the treatment of Crohn's disease.~   "
152557|NCT01569490|"~     This study is designed to test the hypotheses that incentives can increase both participation~     in smoking cessation treatment and resulting cessation rates, when they are offered to~     Medicaid BadgerCare Plus pregnant smokers.~   "
152558|NCT01569477|"~     This study is designed to test the hypotheses that incentives can increase both participation~     in smoking cessation treatment and resulting cessation rates when they are offered to~     Medicaid BadgerCare Plus members.~   "
152559|NCT01569464|"~     The purpose of the study is to show that Rotigotine improves Restless Legs Syndrome (RLS)~     symptoms in subjects with moderate to severe RLS during both day and evening.~   "
152560|NCT01569451|"~     The purpose of this study is (1) to determine if rituximab induction therapy followed by~     glatiramer acetate (GA) is substantially superior to placebo induction followed by GA for the~     treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis~     (RMS) and (2) to explore the changes in lymphocyte populations in the CNS as a consequence of~     treatment with rituximab followed by chronic GA therapy.~   "
152567|NCT01569360|"~     Corsets are often used in the management of patients with a spinal cord injury. They may help~     to rigidify the patients' trunk which might help some patients to sit upright; their use may~     also reduce the sensation of dyspnea some patients have while sitting upright. Due to spinal~     cord injury, abdominal muscles are weakened which can contribute to alter the respiratory~     function of the patients. But the corset by rigidifying the abdominal wall can improve the~     efficiency of the respiratory muscles in some patients and reduce dyspnea in the sitting~     position for some patients. However, when patients with spinal cord injury are followed over~     time, one can observe that some patients discontinue corset use. The investigators observed~     that the patients who pursue the corset use still have a significant improvement of their~     respiratory function with the corset while the patients who have discontinued the use have~     improved their respiratory function in the upright position (without the corset). As of now,~     the investigators do not know whether the use of the corset is discontinued because of a~     spontaneous improvement of the respiratory function or whether discontinuing the use of the~     corset may help to develop abdominal spasticity and therefore to improve respiratory~     function. The investigators seek to investigate this issue in order to optimize the~     management of patients who present spinal cord injury.~   "
152568|NCT01569347|"~     The aim of this study is to determine the clinical, genetic and environmental factors~     associated with the phenotype severe psychotic symptoms caused by cocaine.~   "
152569|NCT01569334|"~     Heart transplantation is the best option for patients with end-stage heart failure. Cardiac~     allograft vasculopathy (CAV) is the leading cause of death following cardiac transplantation~     and is not managed by current therapies. Its pathogenesis traduces in an accelerated form of~     coronary artery disease (CAD) with similarities to atherosclerosis but also particular~     features of endothelial dysfunction associated to the alloimmune conflict and humoral~     responses toward the graft. Intravascular ultrasound (IVUS) is the validated invasive method~     for late CAV diagnosis, but occurs lesions are established. Identification of reliable~     non-invasive early endothelial injury biomarkers that reflect mechanisms of cardiac damage~     thus remain a major challenge to optimize therapeutic management of post transplant~     morbidity. Endothelial dysfunction is a central feature of both CAV and CAD and results from~     a desquilibrium in the balance of endothelial lesion and repair that is partly controlled by~     recipient immune system. Through their expression of receptors sensing antibodies (FcR CD16)~     and endothelial stress-induced signals (CX3CR1 fractalkine receptor and NKG2D MICA~     receptors), Natural Killer (NK) cells represent effector cells with unique potential to~     generate both humoral and innate immune injury of graft endothelium.~   "
152570|NCT01569321|"~     Breast cancer is the first cancer in women, the second etiology of death by cancer and the~     first cause for women between 35 and 55 years.~      Diagnostic tools and large screening have been realized with positive impact in a recent~     review with 31% less likely to die of breast cancer over nearly 30 years compared to women~     who didn't get regular screening mammograms. Diagnostic tools and treatment also are~     improving continuously.~      However, for some women, breast cancer diagnosis is difficult, in case of high density~     breast, breast modifications after surgery… In these cases, breast MRI is currently the best~     imaging tool, with high sensitivity about 90% but with a lower specificity about 60%, that~     lead to futile biopsies.~      Recently, molecular imaging with PET-CT scan with 18FDG has permitted to widely modify cancer~     treatment.~      However, PET-CT scan is not a good imaging tool for initial diagnostic of breast tumor~     because of a lack in spatial resolution about 8mm. So, researchers developed dedicated PET~     scan for breast, called Positron Emission Mammography. Our project is in this field of view~     and is named CLEARPEMSONIC.~      First clinical studies with PEM showed very good performance of this imaging modality for~     initial evaluation of breast tumors. PEM performance is not affected by breast density,~     hormonal status. Spatial resolution is less than 3mm. PEM seems complementary with MRI,~     adding a better specificity value.~      In the field of CERIMED, ClearPemSonic Project aims to evaluate an new imaging tool which~     combined PEM scan and ultrasonography.~      Technologic evaluation was made. Now a feasibility study is the first step for clinical~     applications.~      The main objective of this project is to confirm the feasibility of PEM scan with the~     ClearPEmSonic.~      Secondary objectives are to compare results with other conventional imaging modalities and~     MRI.~      The gold standard will be histology of the breast tumor.~   "
152571|NCT01569308|"~     Objective: To determine the value of pulse pressure variation (ΔRESPPP) to predict fluid~     responsiveness in patients ventilated with low tidal volumes (VT), and to investigate whether~     a lower ΔRESPPP cut-off point should be used when patients are ventilated with low tidal~     volumes.~      Methods: This cross-sectional, observational study included 37 critically ill patients with~     acute circulatory failure requiring fluid challenge. They were sedated and mechanically~     ventilated with Tidal Volume (VT) 6-7 ml/kg IBW (ideal body weight), monitored by pulmonary~     artery catheter and arterial line. Mechanical ventilation and hemodynamic parameters,~     including ΔRESPPP, were measured before and after fluid challenge with 1,000 ml crystalloids~     or 500 ml colloids. Fluid responsiveness was defined as an increase of at least 15% in~     cardiac index.~      The present study was designed to (1) determine the value of ΔRESPPP to predict fluid~     responsiveness in patients ventilated with low tidal volumes, and (2) to investigate whether~     a lower ΔRESPPP cut-off point should be used when patients are ventilated with low tidal~     volumes.~      The study hypothesis is not a good predictor of fluid responsiveness in patients ventilated~     with low tidal volumes.~   "
152572|NCT01569295|"~     The primary objective of this study is to evaluate the effect of the addition of idelalisib~     (IDL [GS-1101, Zydelig®]) to bendamustine + rituximab (BR) on progression-free survival (PFS)~     in participants with previously treated chronic lymphocytic leukemia (CLL)~   "
152573|NCT01569282|"~     Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in~     patients planned for curative pancreatic resection in whom peroperative findings makes~     resection impossible.~   "
152574|NCT01569269|"~     The purpose of this study is to test whether people with symptoms of chemotherapy-induced~     peripheral neuropathy (CIPN) receive physical or psychological benefits from participating in~     a six-week Reiki, Yoga, Meditation, or Educational experience.~   "
152575|NCT01569256|"~     Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting~     follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin~     like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth~     factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome~     (OHSS).~   "
152576|NCT01569243|"~     This study is a 2-arm randomized controlled trial examining the effect of personalized text~     messages on physical activity and clinical outcomes in patients with type 2 diabetes~     mellitus.~      The investigators hypothesize that:~      i. The use of personalized text messages will promote physical activity in patients with~     T2DM.~      ii. Increased physical activity and behavior change correlate with better clinical outcomes~     (Change in HbA1c).~      iii. The text messaging program will lead to sustained physical activity behavior change in~     patients with T2DM~   "
152578|NCT01569217|"~     The aim of this study is to better discriminate respiratory muscle dysfunction by comparing~     the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the~     conventional tests of respiratory muscle strength. The final objective is to better select in~     the future the patients who need more specific assessment of diaphragmatic function like~     maximal transdiaphragmatic pressure measurement and phrenic nerve stimulation.~   "
152579|NCT01569204|"~     The Purpose of this trial is:~        -  to determine complete response rate (CRR) after six cycles of chemotherapy~        -  to determine complete remission rate (CR/CRr) as final treatment outcome after~          completion of treatment~   "
152580|NCT01569191|"~     Seasonal allergic conjunctivitis (SAC) is an irritating eye condition that affects many~     people, caused by hypersensitivity to normally harmless substances such as pollen, and often~     accompanies seasonal hay fever. Treatments that can be used before initiating medical therapy~     include artificial tear supplements (ATS) and cold compresses (CC). However, there is no~     evidence in the scientific literature that demonstrates their efficacy compared to no~     treatment or their combined effect with anti-allergic medication. Therefore the investigators~     aim to examine the efficacy of ATS and CC alone, in comparison to anti-allergic medication,~     and CC in combination with anti-allergic medication. In addition, the investigators also aim~     to determine the time course of ocular allergic reactions. At the end of the study the~     investigators will be able to see whether or not ATS and CC are effective in treating SAC.~   "
152581|NCT01569178|"~     This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase~     III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone~     marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with~     reduced left ventricular ejection fraction(</=45%) after successful reperfusion for acute~     myocardial infarction when compared to a control group of patients undergoing best medical~     care.~   "
152582|NCT01569165|"~     The aim of this study was to determine whether rinsing with water or cleansing teeth after~     topical fluoride therapy affect the dental plaque pH.~   "
152583|NCT01569152|"~     The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate~     (MTX) in participants with active rheumatoid arthritis (RA) despite MTX therapy. The primary~     hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as~     measured by the percentage of participants who achieve American College of Rheumatology 20~     (ACR 20) response after 12 weeks of treatment.~   "
152584|NCT01569139|"~     Medical information is increasingly processed electronically. This study will describe the~     similarities and differences in the data recorded by different databases of electronic~     healthcare database. These will include the General Practice Research Database (GPRD) and the~     Myocardial Ischaemia National Audit Project (MINAP) and hospital episode statistics (HES).~   "
152585|NCT01569126|"~     The purposes of this study are to look at safety, how well the study drug (LY110140) is~     tolerated, and how much of the study drug gets into the blood stream when given as single~     dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will~     participate in SD portion for approximately 6 weeks and in MD portion for approximately 10~     weeks.~   "
152586|NCT01569113|"~     The purposes of this study are to compare the effects on ovarian activity of quick starting a~     Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.~   "
152587|NCT01569100|"~     The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known as statins,~     have recently been demonstrated to improve endothelial function. Additionally, numerous~     studies have shown statins as having antiinflammatory and cell-signaling effects together~     with a selective up-regulation of the eNOS activity. These findings are of potential benefit~     for the prevention of cerebral vasospasm after a aneurysmal subarachnoid hemorrhage. Indeed,~     one of the possible mechanisms for this vasospasm is the eNOS depletion or even increase of~     eNOS expression after the hemorrhage. The purpose of this study is to observe the immediate~     effect of statins after aneurysmal subarachnoid hemorrhage (aSAH) in cerebral vasospasm and~     outcome at one year.~   "
152588|NCT01569087|"~     The purpose of the study is to compare safety and efficacy of a single dose of~     empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5~     μg/kg/day.~   "
152589|NCT01569074|"~     The purpose of the study is to evaluate the effectiveness of four dosing regimens of~     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking~     methotrexate but not responding. The study will last for 12 weeks.~   "
152590|NCT01569061|"~     The primary objective of this study is to determine the effectiveness of~     transvaginally-delivered low level laser therapy (LLLT) versus Sham in the treatment of~     overactive bladder symptoms in women. The secondary objective is to determine the effect of~     transvaginally-delivered LLLT vs. sham on the quality of life.~   "
152591|NCT01569048|"~     Various maneuvers are commonly used to achieve the ideal operative field necessary for~     successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor~     agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the~     hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral~     vasoconstriction thus it is thus theologically appropriate for reducing bleeding during~     intranasal operation.~      The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor~     agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to~     remifentanil , an ultrashort-acting opioid.~   "
152592|NCT01569035|"~     This study examines using oral anti coagulant warfarin in the management of unexplained~     oligohydramnios improve the perinatal outcome with little or no complications to the mother~     or the neonates.~   "
152593|NCT01569022|"~     Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder~     (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in~     patients with PTSD compared to those without PTSD and contribute to worsening cognitive and~     behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment~     of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general~     population. The proposed study aims at comparing the efficacy, tolerability, and adherence of~     oral appliances-an alternative therapy to OSA- to CPAP. The study is instrumental in~     identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would~     predict oral appliance response~   "
152594|NCT01569009|"~     The primary aim of this study is to examine the physical activity levels of patients with~     bronchiectasis.~      Subsidiary aims are:~        1. To examine whether there is a relationship between the physical activity levels of~          patients with bronchiectasis and clinical phenotype (disease severity, exercise~          capacity, quality of life or other symptoms of their disease). The investigators also~          want to explore the relationship between physical activity levels and readiness to~          change physical activity behaviour (stages of change, self-efficacy, decisional balance~          and processes of change).~        2. To assess the feasibility and acceptability of the physical activity assessment tools:~          ActiGraph, ActivPAL, pedometer and the International Physical Activity Questionnaire.~      Hypothesis:~      Patients with bronchiectasis will have low levels of physical activity, and this is related~     to their clinical phenotype (disease severity, exercise capacity, quality of life and other~     symptoms of their disease) and also their readiness to change physical activity behaviour~     (stages of change, self-efficacy, processes of change and decisional balance).~   "
152595|NCT01568996|"~     This is a pilot study to see if oral administration of freeze dried, powdered broccoli~     sprouts have any effect on whether moles end up becoming melanoma.~   "
152596|NCT01568983|"~     The purpose of this study is to investigate the effects of berry juices containing different~     levels of polyphenols on blood pressure and other cardiovascular risk factors.~      The study is a 12 week double blinded randomized controlled intervention trial. The subjects~     will be divided in three groups where one receives a placebo juice while the two other will~     consume 0.5 liter of juice containing different levels of polyphenols. Blood pressure will be~     monitored and blood samples will be taken.~   "
152597|NCT01568970|"~     The large number of people on long-term sick leave is a major public health concern in~     Norway. The main causes of disability are musculoskeletal and mental disorders. Long-term~     sick leave causes a decline in individual life-quality, is associated with increased risk for~     mental disorders and represents a very large cost for the Norwegian society.~      The purpose of this study is to determine whether the patients included return to work after~     rehabilitation at Hysnes Rehabilitation Centre. This includes an investigation of what is~     considered to be the effect of Return-to-work rehabilitation measured before, during and~     after the stay at the rehabilitation centre:~      The study specifically looks at the effect of structured and standardized return-to-work~     follow up of the patient, including contact with stakeholders (general practitioner, social~     security office and workplace).~      In addition there is a need to describe the patients participating in the program. The~     aetiology of complex symptom disorders is poorly understood and the role of genetics and~     stress is not translatable to a complex symptom population. This complicates the transition~     from current biological research to a clinical use regarding these patients. If the~     investigators can assist in understanding how these patients, who are multiusers of health~     care and have received sickness benefit for a long time, develop their disorders and~     symptoms, it will be of great importance to the Norwegian community. Therefore the study~     consists of multimodal measurements of the patients before, during and after a rehabilitation~     programme at Hysnes Rehabilitation Centre. These measures include genotype, saliva cortisol,~     medical-, psychological-, physiological diagnostics and work related factors.~      Related aims:~      Investigate if multidisciplinary treatment based on acceptance and commitment therapy,~     contributes to normalisation of cortisol release with regards to a standardized stress test.~      See wether individual differences regarding the stress profile can predict return to work in~     patients with complex symptom disorders.~      Investigate genetic risk factors in relation to Return to Work rehabilitation and identify~     treatment moderators in a multidisciplinary rehabilitation program.~   "
152598|NCT01568957|"~     Community ambulation is a highly complex skill requiring the ability to adapt to increased~     environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking~     may severely compromise the ability to participate fully in community living. Unfortunately,~     current rehabilitation practice for stroke fails to adequately address dual-task limitations;~     individuals with stroke continue to exhibit clinically significant dual-task costs on gait at~     discharge. As a result, many stroke survivors are living in the community with residual~     deficits that may increase disability in the real world and lead to falls with devastating~     consequences. To address this issue, the proposed study investigates the efficacy of~     dual-task gait training on attention allocation and locomotor performance in~     community-dwelling stroke survivors. Because walking in the real world often requires~     time-critical tasks and obstacle avoidance, the investigators will test the impact of~     dual-task gait training on cognitive-motor interference during walking at preferred speed and~     at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2). The~     investigators will also evaluate the effects of the intervention on community reintegration~     and participation (Aim 3).~   "
152599|NCT01568944|"~     The investigators hypothesize that blood dendritic cells harbor pathogens from the oral~     cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.~   "
152600|NCT01568931|"~     Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of~     ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of~     myocardial tissue.~      Although the use of thrombus aspiration with PCI can result in improved rates of normal~     epicardial flow and myocardial perfusion, several unmet needs remain.~      Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of~     thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective~     in patients with STEMI.~   "
152601|NCT01568918|"~     Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a~     large portion of this population which results in increased morbidity as a result of~     increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital~     stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in the~     incidence and duration of postoperative urinary retention and therefore a reduction in~     morbidity related to treatment of urinary retention as well as shortened hospital stays.~   "
152602|NCT01568905|"~     Smoking remains a leading cause of preventable disease and premature death worldwide.~     Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half~     of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine~     in cigarettes to the point that they are rendered non-addictive can potentially be an~     effective public policy measure that can significantly reduce tobacco-related mortality and~     morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking~     Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product~     standards including placing limits on the allowable nicotine content of cigarettes.~     Currently, no reduced nicotine cigarettes are available that will allow studying the~     feasibility of this policy measure. The National Institute on Drug Abuse has contracted with~     Research Triangle Institute to assist in the development of cigarettes with varying nicotine~     content that can be made available to researchers. They have established a contract that will~     result in the manufacture of 9 million cigarettes to be distributed to the research~     community. Prior to full production, the palatability and nicotine intake of these cigarettes~     in smokers must be determined.~   "
152603|NCT01568892|"~     Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo-~     controlled, functional monotherapy phase to quantify the antiviral activity attributable to~     dolutegravir (DTG) in HIV-1 infected, ART-experienced adults who are experiencing virological~     failure on an Integrase inhibitor containing regimen (current RAL or ELV failures), with~     evidence of genotypic resistance to RAL or ELV at study entry. Thirty subjects will be~     randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B) with the current~     failing regimen for 7 days (RAL or ELV should be discontinued prior to dosing with DTG). At~     Day 8, subjects from both arms will enter an open label phase and receive open label DTG 50mg~     BID with an optimized background regimen containing at least one fully active drug.~   "
152604|NCT01568879|"~     The aim of this study is to test the effectiveness of a pharmacist-staffed, protocol-based~     chronic disease management program compared to patients receiving usual care in achieving a~     target serum uric acid level in patients with recurrent gout.~   "
152605|NCT01568866|"~     The primary objective of this study was to compare progression-free survival in patients with~     multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus~     dexamethasone or bortezomib plus dexamethasone.~   "
152606|NCT01568853|"~     The role of complement system in bridging innate and adaptive immunity has been confirmed in~     various invasive pathogens. The aim of this study is to investigate the alteration of~     complement C3 in patients with severe abdominal sepsis and evaluate the role of complement C3~     depletion in prognosis of such patients. The relationship between complement C3 depletion and~     adaptive immunity is studied meanwhile.~   "
152607|NCT01568840|"~     The purpose of this study is to assess the effectiveness of global postural reeducation~     relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.~   "
152608|NCT01568827|"~     Pilot study to determine whether daily consumption of blackraspberry powder (high in~     polyphenols) can reduce markers of inflammation and to determine whether genetics influence~     baseline levels of inflammatory markers as well as individual's response to polyphenols. A~     total of 10 males participated in this cross-over study.~   "
152609|NCT01568814|"~     Morning only low volume PEG with low reside meals may enhance patient tolerability and have~     similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG~     with standard diet.~   "
152610|NCT01568801|"~     This is a RCT studying the effectiveness of the Singapore Program for All Inclusive Care for~     the Elderly (SingaPACE) demonstration project over a 36 month period. SingaPACE is modelled~     on the US PACE home and community based service that acts as an alternative to institutional~     care. The comparator is best referrals for care as currently arranged through the Agency for~     Integrated Care (AIC) and referred by medical social workers. This research aims to determine~     how the SingaPACE model of health and social care affects use of emergency and acute care~     hospital services, institutional care, the quality of life (QOL) and satisfaction of the~     participants aged 60+ and their caregivers.~      The hypotheses to be tested are:~      H01: The elderly in SingaPACE will have fewer admissions to accident & emergency (A&E)~     hospitalization than the elderly who are not in SingaPACE.~      H02: The elderly in SingaPACE will have fewer admissions to acute care hospitalization than~     the elderly who are not in SingaPACE.~      H03: The elderly in SingaPACE will delay first admission to institutionalized nursing home~     care more than the elderly who are not in SingaPACE.~      H04: The elderly in SingaPACE clients will have a higher QOL compared to the elderly who are~     not in SingaPACE.~      H05: Caregivers of the elderly in SingaPACE will have a lower care-giving burden compared to~     caregivers of the elderly who are not in SingaPACE.~   "
152611|NCT01568788|"~     Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May,~     2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza~     vaccine of Hualanbio has obtained production permission and marketing authorization in May,~     2008.~      In order to further investigate the safety and immunogenicity of the vaccine in the market,~     The clinical observation was planned to be conducted in Mianyang city (Yanting County),~     Sichuan Province, China.~   "
152612|NCT01568775|"~     This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy~     subjects and patients with End Stage Renal Disease on hemodialysis.~   "
152613|NCT01568762|"~     This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258~     (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in~     patients with well-controlled mild to moderate asthma.~   "
152614|NCT01568749|"~     A study investigating the pharmacokinetic profiles of four extended release paracetamol~     formulations~   "
152615|NCT01568736|"~     The hyper IgD syndrome (HIDS) is an inflammatory disease caused by mevalonate kinase~     deficiency. There is no cure, and available treatments of HIDS febrile episodes have shown~     limited clinical efficacy. The development of effective interventions for HIDS is limited by~     our poor understanding of the disease. The goal of the study is to better characterize the~     inflammatory response during HIDS episodes and to determine the relationship between this~     response and blood and urine markers of mevalonate kinase deficiency. This knowledge will~     help us learn more about the cause of the disease and should lead to the identification of~     new disease biomarkers that can be used to evaluate clinical efficacy in future therapeutic~     trials.~      The primary hypothesis is that the costimulatory B7 glycoprotein abnormalities identified in~     the murine MKD model will be recapitulated in sera obtained from human HIDS patients, either~     before, during or after febrile episodes. The secondary hypothesis is that B7 glycoprotein~     molecule levels will correlate with clinical symptomatic severity score, other known~     biomarkers of HIDS, markers of inflammation and or markers of isoprenoid metabolism.~   "
152616|NCT01568723|"~     The purpose of this study is to determine biomarkers which can predict response to ablation~     therapy in patients with Barretts esophagus.~   "
152644|NCT01568359|"~     The purpose of the study is to evaluate the Calcium homeostasis in adult patients with~     uncontrolled acromegaly. The measurements will be repeated 3-6 months after the treatment of~     acromegaly (surgical or medical). The control group consists of patients with nonfunctioning~     pituitary tumors who will undergo surgical removal.~   "
153157|NCT01561638|"~     The pulsed dose RF treatment in various painful disorders may provides better pain relief~     with longer duration compared to previous Pulsed Radiofrequency (PRF) treatment in similar~     clinical settings. Also, there would has not been any worrisome complications from the~     procedures.~   "
152617|NCT01568710|"~     Background:~      - Many people with sickle cell disease have repeated episodes of severe pain that lasts for~     days, requiring hospital care. These episodes, called pain crises, may be caused by changes~     in blood flow. Researchers want to study blood flow in people with sickle cell disease who~     are having a pain crisis and compare it with their blood flow after the pain crisis has~     resolved. They also want to compare these measurements against blood flow in healthy people~     who do not have sickle cell disease.~      Objectives:~      - To study whether changes in blood flow cause pain crises in people with sickle cell~     disease.~      Eligibility:~        -  Individuals at least 18 years of age who have sickle cell disease and are being treated~          for a pain crisis.~        -  Individuals at least 18 years of age who have sickle cell disease and are not~          experiencing a pain crisis.~        -  Healthy volunteers matched by age and gender with the participants who have sickle cell~          disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants having a sickle cell pain crisis will have two visits, one during the~          crisis and one about 4 weeks after the crisis has resolved.~        -  Participants not having a sickle cell pain crisis will have one or two study visits.~          Blood samples will be collected during at least one of these visits.~        -  Healthy volunteers will have one or two study visits. Blood samples will be collected~          during at least one of these visits.~        -  During each visit for all participants, cameras and blood flow monitoring equipment will~          be used to measure blood flow in the forearm.~      sickle cell disease.~   "
152618|NCT01568697|"~     Background:~      - Gum disease is a condition in which the tissue around the tooth root becomes swollen and~     infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and~     how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune~     system of an individual handles these bacteria. Researchers want to look at the oral bacteria~     and genetic immune problems of different people to learn how these affect gum disease and~     other conditions of the mouth.~      Objectives:~      - To study how immune system problems may lead to problems in the mouth, including gum~     disease.~      Eligibility:~        -  Children and adults at least 7 years of age who have genetic problems with their immune~          system.~        -  Healthy adults that have periodontal disease~        -  Health adults that do not have periodontal disease~      Design:~        -  This study will involve a screening visit and a study visit.~        -  Participants will be screened with a medical history, blood work and a full oral and~          dental exam, including dental x-rays and photos.~        -  The study visit will involve collection of blood, urine, and other samples, including~          saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional~          oral and dental exams will be performed. Participants will also answer questions about~          any current medical or dental problems.~   "
152619|NCT01568684|"~     Background:~      - Antidepressants help many people with depression, however, some do not seem to benefit as~     much. Currently, it is not possible to determine who will improve with certain~     antidepressants. Studies have shown that genes may influence whether an antidepressant works~     for an individual. Other studies have shown that depressed people tend to have lower levels~     of a chemical called glutamate in parts of their brain, and that glutamate levels increase~     after recovering from depression. Researchers want to study the antidepressant citalopram~     (Celexa) to see how it affects glutamate levels in the brain. They also want to study how a~     person s genes affect their response to this treatment.~      Objectives:~      - To see whether glutamate levels and certain genes affect how a person responds to a~     particular antidepressant medication.~      Eligibility:~      - Individuals between 25 and 55 years of age who have been diagnosed with major depression~     (without psychotic features). Participants may not have tried more than three antidepressant~     treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will answer~          questions about mood and current feelings of depression, as well as family history of~          depression. Blood and urine samples will be collected.~        -  This study will have two phases. The first phase may last up to 7 weeks depending on~          current antidepressant use and involves one to seven outpatient visits. The second phase~          lasts 8 weeks and involves five outpatient visits, one every 2 weeks.~        -  In the first phase, participants will stop taking their current antidepressant~          medications for at least 2 weeks before the next phase of the study. Participants who~          are on fluoxetine (Prozac) will need to be off it for 6 weeks.~        -  At the end of this phase, participants will have brain imaging studies to look at brain~          function and chemistry.~        -  In the second phase, participants will take citalopram at the standard dose. They will~          answer questions about mood and response to the medication. They will also provide blood~          and saliva samples for tests.~        -  At the end of this phase, participants will have brain imaging studies to look at brain~          function and chemistry.~   "
152620|NCT01568671|"~     Background:~      - The way that the body burns calories is known as energy expenditure. Some studies show that~     when we are cold, we burn more calories to keep our bodies warm. Brown fat is a special kind~     of fat that can use energy to keep the body warm. Small animals and infants have been known~     to have brown fat for many years. Recently, it has been suggested that adult humans also have~     brown fat. If brown fat becomes active (burns calories) in adult humans when exposed to cold,~     then these people would tend to burn off more calories and might not gain weight easily.~     Learning more about the relationship between energy expenditure, brown fat, environmental~     temperature, and body temperature may help explain why some people become obese and other~     people do not.~      Objectives:~        -  To better understand how the body burns calories when exposed to different temperatures.~        -  To study brown fat and how it burns calories in cold temperatures.~      Eligibility:~        -  Healthy men between 18 and 35 or 55 and 75 years of age.~        -  Healthy women between 18 and 35 years of age.~        -  To control for ethnicity, participants must be non-Hispanic whites or African Americans.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will stay in the Metabolic Unit of the National Institutes of Health~          Clinical Center as inpatients for no more than 14 days. The length of the hospital stay~          will depend on how participants respond to the different study temperatures.~        -  Every afternoon, participants will walk for 30 minutes on a treadmill. All meals will be~          provided.~        -  Participants will stay up to 5 hours per day in a specialized room with different~          temperature settings. Temperatures will range from about 61 degrees to 88 degrees~          Fahrenheit. Body temperature, activity, calorie burning, and cold/hot sensations will be~          monitored. On the study day of the coldest temperature, participants will have an~          imaging study to look for brown fat activity.~        -  Participants will be compensated for their time and participation at the end of the~          study.~   "
152621|NCT01568658|"~     Background:~      - Some nerve and muscle disorders that start early in life (before age 25), like some forms~     of muscular dystrophy, can run in families. However, the genetic causes of these disorders~     are not known. Also, doctors do not fully understand how symptoms of these disorders change~     over time. Researchers want to learn more about genetic nerve and muscle disorders that start~     in childhood by studying affected people and their family members, as well as healthy~     volunteers.~      Objectives:~      - To better understand nerve and muscle disorders that start early in life and run in~     families.~      Eligibility:~        -  Individuals at least 4 weeks old with childhood-onset muscular and nerve disorders,~          including those who have a later onset of a disorder that typically has childhood onset.~        -  Affected and unaffected family members of the individuals with muscular and nerve~          disorders.~        -  Healthy volunteers at least 4 weeks old with no nerve or muscle disorders.~      Design:~        -  Participants will be screened with a physical exam and medical history. Genetic~          information will be collected from blood, saliva, cheek swab, or skin samples. Urine~          samples may also be collected.~        -  Healthy volunteers and unaffected family members will have imaging studies of the~          muscles. These studies will include magnetic resonance imaging (MRI) and ultrasound~          scans. Results will be compared with those from the affected participants.~        -  All participants with nerve and muscle disorders will have multiple tests, including the~          following:~        -  Imaging studies of the muscles, including ultrasound and MRI scans.~        -  Imaging studies of the bones, such as x-rays and DEXA scans.~        -  Heart and lung function tests.~        -  Eye exams.~        -  Nerve and muscle electrical activity tests and biopsies.~        -  Video and photo image collection of affected muscles.~        -  Speech, language, and swallowing evaluation.~        -  Lumbar puncture to collect spinal fluid for study.~        -  Tests of movement, attention, thinking, and coordination.~        -  Participants with nerve and muscle disorders will return to the Clinical Center every~          year. They will repeat the tests and studies at these visits.~   "
153194|NCT01561144|"~     The purpose of the study is to analyze the different patient profiles implanted with an~     Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient~     prognosis as a function of clinical profile, implant indication, arrhythmias incidence,~     treatments or device programming.~   "
152622|NCT01568645|"~     Background:~      - About one-tenth of adults with sickle cell disease have pulmonary hypertension (high blood~     pressure in the lungs). This condition can cause shortness of breath, pain crisis, and~     congestive heart failure. It may even lead to death. Researchers want to test the drugs~     imatinib and carvedilol to see if they can treat high blood pressure in the lungs. Both drugs~     have been used to treat other types of heart problems, but they have not been tested as a~     treatment for high blood pressure related to sickle cell disease.~      Objectives:~      - To see if imatinib and carvedilol are safe and effective treatments for high blood pressure~     in the lungs in adults with sickle cell disease.~      Eligibility:~      - Adults at least 18 years of age who have sickle cell disease and have or may have high~     blood pressure in the lungs.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have different tests of heart and lung function, including a walking test and imaging~          studies. Blood and urine samples will also be collected.~        -  Participants who meet specific criteria will take one of two possible study drugs. Those~          who receive imatinib will take it daily. Those who receive carvedilol will take it twice~          a day.~        -  Participants will have weekly study visits for blood tests and other exams. The study~          drug dose will be adjusted at each weekly visit. It will be increased slowly to reach a~          target dose(based on the participant s weight) or to find a stable effective dose.~        -  Participants may continue to take their study drug for up to 24 weeks, with weekly study~          visits. Regular blood samples and heart and lung function tests will be performed.~        -  After 24 weeks, qualified participants may continue to take their study drug for up to 6~          more months. They will have regular study visits to monitor the treatment.~   "
152623|NCT01568632|"~     Background:~      - Imetelstat is a cancer treatment drug that may slow or stop tumor growth. It may also~     prevent tumors from spreading to other parts of the body. Researchers want to see if it can~     be a safe and effective treatment for children who have solid tumors or lymphoma that have~     not responded to other treatments.~      Objectives:~      - To see if imetelstat is a safe and effective treatment for children who have solid tumors~     or lymphoma that have not responded to other treatments.~      Eligibility:~      - Children and adolescents between 1 and 21 years of age who have solid tumors or lymphoma~     that have not responded to other treatments.~      Design:~        -  Participants will be screened with a physical exam, medical history, and imaging~          studies. Blood and urine samples will also be collected.~        -  Participants will receive imetelstat on the first and eighth day of a 21-day cycle of~          treatment.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Tumor~          biopsies may also be performed.~        -  Participants will keep taking the study drugs for up to a total of 18 cycles as long as~          the disease does not progress and there are no severe side effects....~   "
152624|NCT01568619|"~     The investigators would like to find out if AESCULON®, a new device that non-invasively and~     continuously measures cardiac output using electrical cardiometry, works as well as one~     existing method--Fick method in patients undergoing cardiopulmonary exercise testing.~   "
152625|NCT01568606|"~     The purpose of this study is to define the safety of using bioimpedance for analysis of body~     composition in heart failure patients with ICD devices. The Biospace America InBody 520~     scale, using direct segmental multifrequency bioimpedance, will be utilized to assess~     patients' fat mass, lean muscle mass, and edema status.~      Although the Biospace America InBody 520 scale is routinely used to analyze body composition~     in various settings including the Ahmanson-UCLA Cardiomyopathy clinic, due to theoretical~     concerns of safety, bioimpedance has not been routinely used in patients with ICDs. The~     investigators hope that this study will allow us to routinely analyze body composition in~     heart failure patients with ICDs, information which can be used to help guide dietary,~     exercise, and medical prescriptions for the investigators heart failure patients.~   "
152626|NCT01568593|"~     Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to~     severe Dry Eye Syndrome~   "
152627|NCT01568580|"~     The purpose of this study is to study the evaluation of efficacy and safety of GreenGene~     (Recombinant Factor VIII).~   "
152628|NCT01568567|"~     Lactobacilli are commensal bacteria common to the gut of all mammals studied and~     traditionally associated with foods are considered safe.The established safe use on a~     diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus~     reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of~     humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as~     well as adults.~      Although the tolerability of DSM 17938 in a tablet formulation has earlier been established,~     it is desirable to repeat the assessment in this novel formulation.~   "
152629|NCT01568554|"~     The purpose of this study is to test whether a focused questionnaire and laboratory tests can~     better define risk factors associated with possible genetic porphyria. The investigators~     hypothesize that the genetic carrier state of acute porphyria is distinctive enough that the~     Genetic Carrier Profile the investigators devise through this study will be useful in~     identifying carriers of genetic porphyria among the large population with undiagnosed~     abdominal pain.~   "
152630|NCT01568541|"~     There are controversial data about fluoride intake by children when tooth brushing with~     children's or regular toothpastes. However, a study have showed that children were exposed to~     a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and and~     regular toothpaste, respectively. Fluorides doses were too close and is questioned if there~     is a real clinical relevance in terms of risk of dental fluorosis. It is important to~     evaluate if children's toothpastes does really represent a risk of fluoride intake when~     compared to the regular toothpastes in terms of risk of dental fluorosis. The hypothesis is~     that both children's and regular toothpastes can represente risks of development of dental~     fluorosis and can represent similar fluoride exposure by children.~   "
152631|NCT01568528|"~     The focus of the current project is to advance our understanding of the effects of oxytocin~     (OT) on components of social cognition in schizophrenia (SCZ). Despite the rapid increase in~     our understanding of the role of OT in rodent models of social behavior and an explosion of~     interest in the prosocial effects of OT in healthy controls, little work has been done to~     dissect the potential effects of OT on SCZ subjects with social deficits. Social deficits are~     a crucial aspect of the functional impairments that limit the rehabilitation of patients with~     SCZ. In particular, SCZ patients with enduring negative symptoms (deficit syndrome,~     Kirkpatrick et al. 1989) have prominent social deficits as a core feature of this subtype of~     the illness. Our currently available medications do very little to improve these social~     deficits. Hence it is of utmost public health importance to address the knowledge gap~     regarding the potential of OT to improve social function in this illness. Intact social~     function depends on the competent functioning of several cognitive domains that subserve~     perception of social cues and the generation of motivated social behavior. We propose to~     conduct a pharmacological challenge study of OT vs. placebo administration to study the~     effects of OT on specific components of social cognition in male deficit syndrome SCZ~     subjects.~      Primary Hypothesis: Intranasal OT will improve social cognition in subjects with deficit~     syndrome SCZ.~   "
152632|NCT01568515|"~     Introduction: Although vaccination against HPV and subsequent HPV-related cancers is a~     significant breakthrough, uptake is low. We sought to understand whether a low-cost~     intervention of electronic (text and/or email) appointment reminders coupled with electronic~     health educational messaging about HPV and the HPV vaccine could increase HPV vaccine uptake~     and knowledge among college students.~      Methods: Study participants included both female and male English speaking students between~     the ages of 18-26 who attended a large university in North Carolina. Students were randomized~     to the intervention or control group. Intervention group participants received the electronic~     messaging while the control group received standard of care at the student health center~     across a 7-month study period. Baseline and follow-up survey data was collected. Main outcome~     measures were completion of HPV-2 and HPV-3 and HPV and HPV vaccine knowledge. Study~     recruitment ran from August 2011 to December 2013.~      Results: Completion rates for the intervention and control group were similar for HPV-2 (53%~     vs. 52%) and HPV-3 (34% vs. 32%), respectively. The mean knowledge score at follow-up for~     intervention group participants (n=44, mean knowledge score = 93%, SD = 0.08) was~     significantly higher (p=0.01) than the mean knowledge score at baseline (n=44, mean knowledge~     score = 87%, SD = 0.11). No significant changes in knowledge from baseline to follow-up were~     found for control group participants. The single most important predictor of HPV vaccine~     uptake overall was female gender where female participants were 2.35 times [confidence~     interval (CI) 1.17-4.69] as likely to complete the series as compared to male participants.~      Conclusion: In this sample of college students, the electronic messaging intervention~     increased knowledge but not uptake. More randomized controlled trials on the efficacy of HPV~     vaccine electronic reminder interventions for catch-up age populations for both females and~     males are needed.~   "
152633|NCT01568502|"~     Dobutamine stress echocardiography (DSE) and cardiac magnetic resonance (DCMR) are both~     established non-invasive techniques, used in the clinical routine for the diagnostic~     classification and risk stratification of patients with suspected or known coronary artery~     disease (CAD).~      In this regard, regional wall motion abnormalities (WMA) during dobutamine stress, precede~     the development of ST-segment depression and anginal symptoms, enabling the detection of~     anatomically significant CAD and the assessment of clinical outcomes.~      In a head-to-head comparison between the 2 techniques, favourable diagnostic characteristics~     in terms of higher sensitivity and accuracy were noted for DCMR compared to DSE.~      Although it has been reported that stress induced WMA both in DCMR and in DSE are independent~     predictors for hard cardiac events such as cardiac death or myocardial infarction, the value~     of the 2 techniques for the risk stratification of patients with CAD has not been compared to~     each other so far.~      Comparison of these 2 non-invasive techniques is important, because referring physicians need~     to know which modality is more reliable for the identification of patients at higher risk for~     subsequent cardiac events, who would benefit from early invasive therapy.~      In the investigators study the investigators therefore sought to compare the ability of DSE~     versus DCMR to predict subsequent hard cardiac events and revascularization procedures in a~     patient cohort with high CAD prevalence. Their predictive value was compared to that of~     conventional atherogenic risk factors and to resting WMA. In addition, the investigators~     sought to determine if both techniques are equally suitable for structuring invasive or~     conservative treatment according to the presence or absence of inducible ischemia,~     respectively.~   "
152634|NCT01568489|"~     The objective of this phase 2 study is to evaluate the safety and efficacy of HL-009~     Liposomal Gel in adult patients with mild to moderate atopic dermatitis (AD).~   "
152635|NCT01568476|"~     Following foot and ankle surgery, ultrasound-guided sciatic nerve block (SNB) at the~     popliteal fossa decreases post-operative pain and opioid consumption. At the popliteal fossa,~     the sciatic nerve bifurcates to form the Common Peroneal Nerve (CPN) and Tibial Nerve (TN).~     Studies have shown that when both branches are blocked separately distal to the bifurcation~     site, block onset time is reduced by 30%. Through clinical observation, the investigators~     found that onset time is further shortened when ultrasound-guided SNB is performed at the~     site of bifurcation. This is because the local anesthetic spreads interneurally. The purpose~     of this study is to compare the block onset time of an ultrasound-guided sciatic nerve block~     at the site of nerve bifurcation with the blockade of each terminal nerve separately (TN and~     CPN) distal to sciatic nerve bifurcation.~   "
152636|NCT01568463|"~     Patients experience significant postoperative pain following shoulder surgery, Single shot~     interscalene block is used in ambulatory shoulder surgery for its advantages that include~     significant reduction in acute pain and analgesic requirements, prolonged time to first~     analgesic request, decreased incidence of nausea, as well as earlier hospital discharge.The~     process of nerve block requires several needle passes, with each of them being at risk of~     causing nerve injury either by direct trauma or intraneural injection even with the use of~     the ultrasound. These facts raised concerns and several authors stated that maybe the~     anesthesiologists should be more careful, keep a safe distance from the nerve, and inject the~     local anesthetics into fascial planes containing the nerve and not attempt to place the~     needle in close proximity to the nerve. This study is designed to determine the maximal~     effective distance away from the nerve for the injection to be effective.~   "
152637|NCT01568450|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.~      GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.~   "
152638|NCT01568437|"~     Laparoscopic gastric-bypass surgery (LGBS) is one of the surgical treatments for morbid~     obesity, which is performed under general anesthesia. TAP block is an analgesic strategy~     covering the dermatomes from T6 to L1 and consists of injecting local anesthetic in the TAP~     between the costal margin and the iliac crest, where the thoracolumbar nerves (T6-L1) are~     located. As far as the investigators know, this analgesic technique has never been studied in~     LGBS. The investigators objective is to determine whether an ultrasound (US)-guided TAP block~     provides improved analgesia during the first 24 hours after laparoscopic gastric-bypass~     surgery, compared to conventional therapy only.~   "
152639|NCT01568424|"~     The study objective is to gather post-market clinical data on the use of the CentriMag RVAS~     when used for temporary mechanical circulatory support of the right ventricle in patients~     with acute right ventricular failure from any cause~   "
152640|NCT01568411|"~     This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4)~     and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10 mg~     tablet of TD- 1211 administered orally to fasted subjects.~   "
152641|NCT01568398|"~     The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in~     participants with a history of gastric or duodenal ulcer requiring long-term low-dose aspirin~     therapy will be investigated.~   "
152642|NCT01568385|"~     The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in~     participants with a history of gastric or duodenal ulcer requiring long-term NSAID therapy~     will be investigated.~   "
152645|NCT01568346|"~     This study is being done to find out the number of surgical procedures required to achieve~     clear margins in women with newly diagnosed early stage breast carcinoma. The investigators~     are also looking at the number of additional biopsies performed before surgery, the~     mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma),~     time form diagnosis to local therapy, and evaluation time to local recurrence.~   "
152646|NCT01568333|"~     Decitabine has been reported to have a clinically significant, often long lasting effect on~     the platelet count in myelodysplastic syndromes(MDS). It is also reported that decitabine~     could increase platelet counts by enhancing megakaryocyte maturation and platelet release.~     Immune thrombocytopenia(ITP) is known as an immune-mediated acquired disease characterized by~     transient or persistent decrease of the platelet count. However, refractory ITP is lacking of~     effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data~     from this study may provide some idea of decitabine in the treatment of ITP.~   "
152647|NCT01568320|"~     The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the~     safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of~     acute, complicate Type B aortic dissection.~   "
152648|NCT01568307|"~     There is strong evidence that patients with major depressive disorder (MDD) have an increased~     risk of developing coronary heart disease (CHD). This elevated risk is independent of~     standard risk factors such as smoking, obesity, high cholesterol, diabetes, and high blood~     pressure. The relative risk of developing CHD is proportional to the severity of depression~     (the more severe the depression, the more likely the development of CHD).~      The sympathetic nervous system (the part of your nervous system that makes your heart beat~     harder and faster) is responsible for our flight and fight response to a threatening~     situation. It has been determined that increased sympathetic nervous system activation occurs~     in approximately one in three untreated patients with MDD (with no underlying CHD). There is~     growing evidence linking elevated sympathetic activity to early stages of kidney dysfunction~     and an increased incidence of cardiovascular (heart and blood vessel) disease development~     (eg, heart attacks). Sympathetic nervous system activation over a prolonged period of time~     may also be associated with abnormal blood pressure regulation and the development of insulin~     resistance (an important feature of type 2 diabetes).~      It has been suggested that a certain gene, known as the serotonin transporter (5-HTT) gene,~     may be involved. In particular, work from our group indicates that a particular type of this~     gene, the short form (or short allele) may be important in linking MDD, sympathetic nervous~     activation, and increased cardiac risk.~      This study aims to examine the role of the 5-HTT gene on cardiovascular risk factors~     associated with elevated sympathetic activity in patients with MDD. Additionally, the study~     will examine the effect of serotonin re-uptake inhibitor (SSRI) therapy on these parameters.~      A clearer understanding of these systems and processes will allow for identification of~     patients with increased cardiac risk and development of risk reduction strategies. Such~     information is clinically significant given the link between cardiovascular disease and MDD.~      Hypothesis 1: That MDD patients carrying the s allele of the 5-HTT transporter have higher~     sympathetic activity than homozygous ll patients.~      Hypothesis 2: that MDD patients with elevated sympathetic activity display early signs of~     left ventricular hypertrophy (LVH) and diastolic dysfunction.~      Hypothesis 3: That MDD patients with high sympathetic activity have greater morning surges in~     blood pressure than patients with normal sympathetic activity.~      Hypothesis 4: That MDD patients with elevated sympathetic activity display early signs of~     insulin resistance.~      Hypothesis 5: That SSRI therapy, in particular in those who carry the s allele of the 5-HTT,~     has a favourable effect on blood pressure variability and morning surge in blood pressure,~     sympathetic stress reactivity, and markers of insulin resistance.~   "
152649|NCT01568294|"~     The purpose of this study is to determine the tolerated dose of pomalidomide and also to~     evaluate the pharmacokinetics, safety and efficacy of pomalidomide in patients with~     refractory or relapsed and refractory multiple myeloma.~   "
152650|NCT01568281|"~     This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet~     after a single oral administration of each anastrozole formulation.~   "
152651|NCT01568268|"~     This study was designed to evaluate the treatment efficacy and safety of palonosetron for the~     patients who undergo laparoscopic gynecologic, abdominal or other surgery under general~     anesthesia.~   "
152652|NCT01568255|"~     Statins are a class of drugs that are highly effective at lowering cholesterol levels.~     However, compliance is often limited by symptoms of muscle pain. The investigators would like~     to study Vitamin-D deficient individuals who also have muscle pain due to statin use. About 1~     billion people are estimated to have low or insufficient levels of vitamin D worldwide.~     Patients with low or insufficient levels of vitamin D may develop muscle disease. The purpose~     of this study is to identify if these symptoms are associated with vitamin D deficiency, and~     most importantly, if treatment of vitamin D deficiency can reduce muscle pain that is caused~     by statin treatment.~   "
152653|NCT01568242|"~     Temperature in the vitreous cavity decreases during vitrectomy, and the same effect is seen~     during an uneventful phaco surgery. Significant changes occur between the baseline~     temperature and after every step of the surgery.~   "
152654|NCT01568229|"~     The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of~     schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in~     period on their current antipsychotic treatment, patients will be randomized to one of the~     four treatment arms as add-on therapy for a treatment duration of up to 3 months.~   "
152655|NCT01568216|"~     The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of~     schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in~     period on their current antipsychotic treatment, patients will be randomized to one of the~     four treatment arms as add-on therapy for a treatment duration of up to 3 months.~   "
152656|NCT01568203|"~     The purpose of this study is to assess the safety and tolerability of AMG 579 following a~     single oral dose administration in healthy subjects (Part A) and in patients with~     schizophrenia or stable schizoaffective disorder (Part B). The study in healthy subjects~     (Part A) concluded, and following a protocol amendment, enrolled only patients with~     schizophrenia or stable schizoaffective disorder (Part B).~   "
152657|NCT01568190|"~     The purpose of the trial is to assess the tolerability of the up-dosing phase of AVANZ Mite~     mix.~   "
152658|NCT01568177|"~     Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in~     heart) with symptoms of persistent chest pain impacts women. There are an estimated 2-3~     million women in the US with MCD and about 100,000 new cases annually. Autonomic nervous~     system (ANS) is part of the central nervous system to help people adapt to changes in their~     environment. It controls what are normally involuntary activities, such as heart rate,~     respiration (breathing), body temperature, blood pressure, and urinary function. However,~     there is a limited understanding of the role of ANS in MCD. This research is proposed to~     investigate cardiovascular reactivity to mental stress and the cardiac (heart) nervous system~     in women with MCD using mental stress testing, peripheral vascular testing, advanced cardiac~     imaging and cardiac autonomic function testing. 100 participants will be recruited in the~     next five years.~   "
152659|NCT01568164|"~     The purpose of this prospective, single-armed, multi-center clinical trial is to further~     establish the safety and feasibility of using the BioVentrix PliCath HF System for the~     treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from~     heart failure.~   "
152660|NCT01568151|"~     This study is being done to see if teaching physicians and people who are at least 50 years~     old and have not been screened within guidelines for colorectal cancer about the importance~     of colorectal cancer screening will increase screenings for colorectal cancer. The~     researchers want to understand what ways will work best to motivate and educate both patients~     and the doctors and nurses who care for them.~   "
152661|NCT01568138|"~     The purpose of the study is to determine the safety, and feasibility of a device, which~     enables LV volume and radius reduction through scar exclusion in patients whose systolic HF~     is due to ischemic cardiomyopathy.~      Appropriate subjects will have akinetic or dyskinetic scar located in the antero-septal LV~     distribution. Use of this device replicates the geometric reconfiguration of the ventricle~     achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating,~     unsupported heart, thereby creating the option of avoiding the use of cardiopulmonary bypass~     pump (CBP).~   "
152662|NCT01568125|"~     It is well known that incretin, particular GLP-１enhances satiety and reduces energy intake in~     controlling appetite and dietary in humans (Flint A, et al. Gutzwiller JP et al.). Recently,~     incretin-based therapy has been attracted a lot of interest (Hare KJ, Knop FK). However, it~     is not clear how the incretin-based therapy affects energy and content of dietary intake in~     patients with type 2 diabetes mellitus (T2DM). Previously, the investigators reported the~     amount of energy and content of dietary intake in type 2 diabetic Japanese patients with more~     than 10 years of long time duration after discovery using questionnaire (Inoue K et al.) and~     the patients were impaired a secretion of active GLP-1 (Kamoi et al).~      The investigators examine whether the incretin-based therapy effects on the energy and~     content of dietary intake in the same patients before and one year after administration of~     incretin-related drugs using the same method previously (Inoue K et al.).~   "
152663|NCT01568112|"~     The primary objective of the study is to evaluate whether premedication with 325 mg~     microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the~     incidence and severity of flushing and GI events following oral administration of BG00012~     dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this~     study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240~     mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration~     dosing schedule in healthy volunteers.~   "
152664|NCT01568099|"~     This is a phase I study to assess the tolerability and safety of 4 injections of two~     different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early~     Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45~     years if there is no evidence for genetic forms of the disease and the diagnosis of~     idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in~     Vienna (Austria) will be involved. Each patient's participation will last 1 year.~      In addition, up to 8 patients will be offered participation within an untreated control~     group.~   "
152665|NCT01568086|"~     This is a phase Ib follow-up study to evaluate long-term safety and tolerability of~     immunization with AFFITOPE AD03 applied during AFFiRiS 005A.~   "
152666|NCT01568073|"~     This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with~     entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa~     Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose~     motor fluctuations.~   "
152667|NCT01568060|"~     The purpose of this study is to collect safety information following routine vaccination with~     Infanrix-IPV among infants and children in Korea.~   "
152668|NCT01568047|"~     The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at~     steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated~     with levodopa/dopa-decarboxylase inhibitor.~   "
152669|NCT01568034|"~     The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa~     pharmacokinetics when administered in combination with immediate release levodopa/carbidopa~     or levodopa/benserazide in Parkinson's Disease (PD) patients.~   "
152670|NCT01568021|"~     This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in~     clinical practice, and will assess the time at which patients are considered for retreatment.~   "
152671|NCT01568008|"~     This is an observational study in patients with POAG or OHT that will collect data on the use~     of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting.~     Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after~     baseline, as per normal clinical practice.~   "
152672|NCT01567995|"~     This was a multicenter, randomised, double-blind, two treatment arms, vehicle (cream base)~     -controlled, parallel-group study in subjects with moderate to severe eczema (defined by~     investigators global assessment (IGA) score greater than or equal to 3).~      Subjects were screened within 3 days prior to randomization. At the screen visit, subjects~     gave informed consent and were then assessed for health status and eligibility for inclusion~     in the study. At the baseline visit, subject eligibility was assessed for randomization (Day~     0). Eligible subjects were randomised to Clobetasone Butyrate 0.05% Cream group or vehicle~     (cream base) group at the rate of 1:1. During the treatment phase, subjects returned to the~     sites in day 7 post-baseline visit for assessment of their disease status and eligibility to~     continue on the study. During the final visit, 14 days after the baseline, subjects returned~     to the study sites for assessment of their disease status before completing the study. In~     addition, the safety and tolerability of Clobetasone Butyrate 0.05% cream were also assessed~     through the whole trial.~   "
152673|NCT01567982|"~     We hypothesize that transcranial direct current stimulation will reduce tobacco withdrawal~     symptoms of tobacco dependent smokers abstinent from smoking for more than 10 hours.~   "
152684|NCT01567839|"~     Infiltration (injecting next to the tooth) injections are common in dentistry and a number of~     studies have shown that articaine anesthetic, when injected next to the tooth as a~     supplemental injection, works very well following a typical inferior alveolar (lower jaw)~     nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine~     with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower~     jaw) infiltration injections of the first molar. The purpose of this prospective, randomized,~     double-blind, crossover study is to compare the degree of anesthesia obtained from the three~     solutions as a primary infiltration injection next to the mandibular first molar. The~     investigators also will record the pain of injection and postoperative pain.~   "
152674|NCT01567969|"~     The Family Health and Development Project (FHDP) is a randomized controlled trial to evaluate~     the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service (IICAPS)~     intervention, targeting emotionally, behaviorally, and/or psychiatrically disordered children~     at risk of a psychiatric inpatient admission and their families. Children and families are~     randomized to receive IICAPS or Home-based Child Treatment Coordination (Home-based CTC), a~     home-based case management intervention for coordination of mental health services for~     children. Approximately 144 children and their families will be enrolled for a 12 month study~     period. Data will be collected through interviews with the child's parent/legal guardian, and~     from the child's teacher, the child's school, and the Department of Social Services (claims~     data). This study will test the hypotheses that children receiving IICAPS will be less likely~     to exhibit out-of-control behaviors and less likely to experience a psychiatric~     hospitalization and/or out-of-home placement during and up to six months post-discharge from~     services.~   "
152675|NCT01567956|"~     The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine~     modified release tablets 1g/die in reducing the symptoms of the disease with respect to the~     proportion of patients with disease remission at the end of the 8 weeks of treatment. It will~     also aim to investigate capability of the treatment in the maintenance of remission after~     four weeks of treatment interruption; histological changes will be also evaluated and~     finally, improvement in the overall quality of life as measured by the Short Inflammatory~     Bowel Disease Questionnaire (SIBDQ) will be investigated.~   "
152676|NCT01567943|"~     The investigators will evaluate the efficacy of a comprehensive 12-week contingency~     management intervention for treating alcohol dependence for persons with severe mental~     illness who are seen within the context of a community mental health center setting. The~     primary contingency will be submission of alcohol-free urines. Additional reinforcers will be~     provided for intensive outpatient addiction treatment attendance. Reinforcers will be~     vouchers or actual items useful for day-to-day living. Participants will be 120 adults~     diagnosed with alcohol dependance and severe mental illness.~   "
152677|NCT01567930|"~     The purpose of this study is to evaluate the activity of temsirolimus in patients who have~     advanced hepatocellular carcinoma (HCC) and have been treated with one previous chemotherapy~     or biologic therapy like sorafenib, but have experienced disease progression or intolerance~     to that therapy.~   "
152678|NCT01567917|"~     Venous thromboembolism (VTE) has harmful effects on morbidity and mortality of cancer~     patients. In Western VTE guidelines, all solid cancer patients receiving abdominal major~     surgery are strongly recommended to receive pharmacologic prophylactic anticoagulation such~     as low molecular weight heparin (LMWH) in the perioperative periods. These recommendations~     are based on the high incidence of postoperative VTE development in Western cancer patients.~     However, there have been many cumulative data about the effect of different ethnicity on the~     VTE development and more and more investigators and clinicians admit that Asian ethnicity has~     lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to apply~     Western guidelines as it is to the clinical situation of Asian cancer patients.~      Although colorectal cancer (CRC) is one of the common cancers and the incidence is rapidly~     increasing in Asia, there have been few prospective data on the incidence of VTE development~     during the postoperative period in Asian CRC patients. To our knowledge, there have been a~     few small-sized prospective studies in Asia and thus clear conclusions could have not been~     drawn based on those studies. Most Korean colorectal surgeons think that the incidence of~     postoperative VTE development is very rare based on their own clinical experiences. They also~     have much concern about the complications such as bleeding that might be caused by routine~     use of pharmacologic thromboprophylaxis during the perioperative periods. Therefore, in most~     clinical situation, many Korean colorectal surgeons do not perform perioperative~     pharmacologic thromboprophylaxis using LMHW. Considering these clinical situations in Asia~     including Korea, the uncritical acceptance of Western guidelines may be inappropriate. The~     necessity of pharmacologic thrombo-prophylaxis can be answered only from our own prospective~     study on the incidence of postoperative VTE development after CRC surgery. Moreover, current~     surgical trend in cancer patients is minimally invasive approach such as laparoscopic~     surgery. However, the necessity of pharmacologic thromboprophylaxis in patients receiving~     laparoscopic cancer surgery has not been evaluated even in Western countries. Western~     guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really~     necessary in cancer patients receiving laparoscopic cancer surgery. On above backgrounds,~     this study was designed.~   "
152679|NCT01567904|"~     Primary Objective:~      - To assess the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of Semuloparin~     [AVE5026] (assessed from the anti-Xa activity of Semuloparin) in children in order to~     determine the dose to be assessed in a clinical efficacy/safety study in this population.~      Secondary Objective:~      - To assess the tolerability of Semuloparin when administered at a weight-adjusted, once~     daily dose for up to 30 days in patients less than 18 years of age with central venous line.~   "
152680|NCT01567891|"~     This study, will take a subject's T cells and teach them to be able to recognize and~     attack the ovarian cancer cells. This is done by putting in a gene or genetic material that~     will change how a subject's T cells work and hopefully get them to attack and kill ovarian~     cancer cells. These new T cells are called engineered T cells because the new gene is~     causing them to become directed toward the ovarian cancer cells rather than their usual~     targets. These are also called gene-modified T cells. For subjects who have the HLA A2~     tissue-type marker, the T cells would be engineered to recognize a substance called~     NY-ESO-1. After putting this new gene in T cells (a procedure called gene therapy) the~     investigators will grow the cells in the laboratory and give these cells back to subjects.~   "
152681|NCT01567878|"~     -  Evaluate the correlation of ultrasound MASEI index with clinical, functional,~          radiographic and laboratorial variables in patients with ankylosing spondylitis.~        -  Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound~          (synovitis, erosions, power doppler) with same variables.~        -  Evaluate correlation between articular and enthesis ultrasound exam in this study.~        -  Compare patients and healthy individuals data, to calculate the ROC curve to estimate~          predictor value of disease.~   "
152682|NCT01567865|"~     The proposed JEV05 study is a four-arm double-blind randomized controlled single center trial~     to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency~     of three lots of JE live attenuated SA 14-14-2 vaccine manufactured in a new GMP facility,~     and to establish non-inferiority of the new vaccine in comparison to a single lot of the same~     vaccine manufactured in the existing facility. The study will enroll a total of 1,000~     Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, JEV05~     will provide local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi~     children. This will be the first step to secure licensure for this life-saving vaccine in~     Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA~     14-14-2 vaccine.~   "
152683|NCT01567852|"~     When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter~     using ketamine for induction than using methohexital.~   "
153203|NCT01561027|"~     The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy~     of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.~   "
152685|NCT01567826|"~     The study will assess the regression of yellow plaque content of the lipid pool after~     aggressive lipid therapy by utilizing NIR spectroscopy. Statin therapy using Rosuvastatin~     10-40 mg will be compared to the statin therapy of either Atorvastatin or Simvastatin. This~     is a single site study. A total of 100 subjects will randomized, of which 40 will receive~     intensive lipid therapy (Rosuvastatin 40mg) and 40 will receive standard care lipid lowering~     therapy.~   "
152686|NCT01567813|"~     This is a post-licensure safety observation cohort study to describe the general safety of~     GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.~   "
152687|NCT01567800|"~     The purpose of this study is to look for low levels of oxygen (hypoxia) in prostate cancer~     using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have~     an effect on how prostate cancer grows and responds to treatments like radiotherapy and~     chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the~     methods used previously.~   "
152688|NCT01567787|"~     The purpose of this study is to determine if Proton Therapy can provide effective and safe~     treatment for Malignant Peripheral Nerve Sheath Tumors of the spine and Neurofibromas of the~     spine.~   "
152689|NCT01567774|"~     Patients with coronary artery disease (CAD) are often treated with dual antiplatelet therapy~     (DAT), including aspirin and clopidogrel, to prevent from recurrent atherothrombotic events.~      Levels of platelet reactivity in patients on DAT can be influenced by concomitant treatment~     with medications that inhibit the CYP3A4 system involved in the activation of clopidogrel.~      Atorvastatin and simvastatin are metabolized by CYP3A4 [Clin pharmacokinetic 2002; 41:~     343-70], whereas the cytochrome P450 mediated metabolism of rosuvastatin appears to be~     minimal and principally mediated by the 2C9 isoenzyme, with little involvement of CYP3A4~     [Clin Ther 2003; 25: 2822-5.].~      Previous studies comparing atorvastatin versus rosuvastatin by means of ex vivo platelet~     function tests have yielded conflicting results.~   "
152690|NCT01567761|"~     The purpose of this study is to examine whether the intraocular pressure of operated people~     under general anesthesia is affected by the artificial respiration method. If it is proven~     that there is such influence, the findings may lead to select the best method for patients~     with increased intraocular pressure.~      In this study, the investigators will monitor the changes observed in intraocular pressure~     caused during an operation in two different artificial respiration methods:~        1. Intermittent positive pressure ventilation (IPPV)~        2. High frequency jet ventilation (HFJV)~      Study recruited 50 patients aged 18 - 40, candidates to elective orthopedic surgery in the~     limbs. These patients do not suffer from general diseases that restrict their daily~     functioning.~      The selection of the type of surgery was done to prevent the involvement of any other factor,~     except the respiration method, determination of intraocular pressure.~      Exclusion Criteria:~        -  Patients who are unable to provide an Informed Consent~        -  Patients suffering from any eye disease~        -  Patients with corneal thickness less than 450 microns or more than 600 microns~        -  Smokers~        -  Patients with pulmonary disease restrictive or obstructive~        -  Patients using bronchodilator~      All patients operated under general anesthesia using total intravenous anesthesia )TIVA)~     method.~      All patients will be resuscitating half of the time of surgery using IPPV, and in the second~     half of surgery using HFJV.~      During the surgery the IOP will be measured by an ophthalmologist who is unaware of the~     respiration method.~      Correction will be made to the intraocular pressure values, depending on the thickness of the~     cornea.~      The results of the measurements will be collected and the clinical significance will be~     reviewed by acceptable statistical methods.~   "
152691|NCT01567748|"~     Central aortic blood pressure (BP) and flow are generally more informative about the health~     condition of the heart and the arterial system compared with BP measured in peripheral~     locations (e.g. arm or leg). However, their clinical impact has been limited due to the cost,~     risk and discomfort associated with their measurements. Peripheral BP is attractive because~     it can be measured relatively easily than central aortic BP. However, peripheral BP is not as~     useful as central aortic BP since the shape of its waveform is different from that of central~     aortic BP. The applicant recently developed two innovative methods, the Individualized~     Transfer Functions (ITF), which is able to estimate the central aortic BP waveform of a~     patient using the measurements of peripheral BP waveform(s). The methods were successfully~     validated using animal and simulated human subjects. The objective of the proposed research~     project is to examine the validity of these innovative methods in human subjects.~      Cardiovascular disease accounts for 1/3 of all deaths and more than $22 billion~     healthcare-related cost in Canada every year. The proposed research project will make~     significant contribution in improving clinical care by the potential of ITF in detection and~     diagnostics of cardiovascular disease. In fact, the proposed research project is a key~     initial step towards our long-term research objective of non-invasive cardiovascular disease~     diagnostics. The success of the proposed research project will demonstrate that ITF can serve~     as a low-cost, non-invasive and convenient alternative for central aortic BP measurement,~     which can further be used for the development of detection and diagnostics methods for a~     number of cardiovascular diseases (e.g. aortic valve impairment and peripheral arterial~     disease) by virtue of the relevant health and disease conditions of central and peripheral~     arterial vessels that ITF can deliver.~   "
152692|NCT01567735|"~     The purpose of this study to evaluate the efficacy, safety and tolerability of TMC435 in~     combination with Peginterferon alfa-2a (PegINF alfa-2a) and ribavirin (RBV) in both~     treatment-naïve and treatment experienced, chronic hepatitis C (HCV) virus, genotype-4~     infected patients.~   "
152693|NCT01567722|"~     RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related~     malignancies.~   "
152694|NCT01567709|"~     This phase I trial studies the side effects and the best dose of alisertib when given~     together with vorinostat in treating patients with Hodgkin lymphoma, B-cell non-Hodgkin~     lymphoma, or peripheral T-cell lymphoma that has come back. Alisertib and vorinostat may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
152695|NCT01567696|"~     The purpose of this study is to more fully understand the reason(s) that joint replacement~     implants fail and to better identify diagnosis and outcome methods both pre-operatively and~     post-operatively with revision surgery. Analysis of joint replacement failure will include a~     through analysis of laboratory, radiographic, implant, surgical and demographic data.~   "
152696|NCT01567683|"~     This study is designed to assess the tolerability of test product and vehicle in terms of~     skin reactions during repeated topical applications on healthy skin under controlled~     conditions on the basis of the international guidelines for testing of skin irritations (FDA~     Guidance for Industry (1999)).~   "
152726|NCT01567280|"~     The study design consists of a cross-sectional survey on the clinical characteristics of~     patients with asthma and their level of asthma control and current quality of life, and on a~     prospective evaluation of the rate of switch from the uncontrolled/poorly controlled~     condition to the status of controlled asthma. Asthma control will be based on the Asthma~     Control Questionnaire scoring system, that has been fully validated for use in both clinical~     practice and clinical trials and has strong discriminative properties which means that it can~     detect small differences between patients with different levels of asthma control and it is~     very sensitive to within-patient change in asthma control over time.~      Quality of life as a reflection of the control of the disease, will also be evaluated by~     means of the Mini Asthma Quality of Life Questionnaire scoring system.~   "
152697|NCT01567670|"~     The investigators are studying a new treatment for one subtype of obesity. Obesity is not a~     disease. It is a symptom of several different diseases. These diseases have distinct~     etiologies, being caused by aberrations in different mechanisms. Forms of obesity caused by~     such non-critical mechanisms might be corrected fairly easily and safely. The investigators~     are interested in overeating and obesity that is caused by the opioidergic system. The~     opioidergic system appears to be responsible for a subtype of obesity associated with binge~     eating disorder (BED). People, especially with the right genetic predisposition, can become~     addicted to foods that release endorphins, in the way that people become addicted to~     exogenous opiates and other drugs that release endorphins. The particular application in our~     proposed clinical trial is for intranasal (IN) naloxone. The peak levels of naloxone were~     similar and the bioavailability of naloxone intranasally was 100% (the same) of that~     available IV. IN administration of naloxone has since been broadly tested in humans, as~     well, where it has been shown to be safe, with pharmacokinetics similar to those of naloxone~     given by injection .~   "
152698|NCT01567657|"~     The purpose of this study is to determine whether sedation with a combination of pethidin~     hydrochlorid plus midazolam intravenously (i.v.) is superior to propofol i.v. alone in~     relation to blood pressure drops during an transesophageal echocardiographic examination~     (TEE).~   "
152699|NCT01567644|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients~     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.~   "
152700|NCT01567631|"~     The purpose of this research is to compare the classical procedure with intrahepatic~     Glisson's approach for laparoscopic anatomical hepatectomy. The validity, feasibility and~     limitations were assessed objectively through our clinical prospective study. The~     investigators expect laparoscopic anatomical hepatectomy with intrahepatic Glisson's approach~     is safe, effective and feasible.~   "
152701|NCT01567618|"~     This is an open-label, phase II study to evaluate the efficacy and safety of biweekly~     docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line~     therapy.~   "
152702|NCT01567605|"~     The main goal of this project is to determine the effects of lidocaine lubricant on~     cardiovascular function during routine bowel care in individuals with spinal cord injury.~     Bowel care is a common trigger of blood pressure and heart rate changes after spinal cord~     injury. In this project, we will be measuring blood pressure and heart rate non-invasively~     during normal bowel routine (which can be performed in the subject's home or at one of the~     investigators facilities). The measurements will occur twice over a period of 28 days: once~     using lidocaine lubricant and once using normal (placebo) lubricant. The recording equipment~     will be attached and subjects will have complete privacy during their bowel routine. The~     trial will be double-blind, meaning that neither the subject or the Nurse Continence Advisor~     who assists with testing will know which lubricant is being used for each test.~      The use of a lubricant gel containing an anesthetic is the standard of care in many hospital~     facilities when performing bowel care for individuals with spinal cord injury; however, it is~     not often used in the home setting. It is thought that using anaesthetic might reduce the~     cardiovascular effects of bowel care after spinal cord injury. However, it is not known~     whether this is the case.~      The investigators hypothesize that the lidocaine lubricant will alleviate some of the blood~     pressure and heart rate changes that occur during bowel care.~   "
152703|NCT01567592|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients~     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.~   "
152704|NCT01567579|"~     The purpose of this study is to understand how having a heart problem affects~     development,quality of life, and family life in young children and their families. Results~     for children and families with heart disease will be compared to children and families~     without heart disease. The investigators hope that this information may help us to support~     children and families better in the future. All children and families that are seen in the~     HHC Developmental Follow-Up Program will be asked if they would like to take part in this~     study. It is hypothesized that children with congenital heart disease will demonstrate~     developmental delays when compared to normative values.~   "
152705|NCT01567566|"~     The primary objective of this study is to compare the efficacy of two different exercise~     programs for the reduction of pain and disability in a specific subgroup of NSLBP patients~     and aims to investigate the additive effect of hip stabilization exercises. The investigators~     hypothesize that the combined local (segmental) stabilizer and hip stabilizer program (T2)~     will be more effective in reducing pain and disability in NSLBP patients compared to the~     local (segmental) stabilizer program (T1).~   "
152706|NCT01567553|"~     While significant progress has been made on medical imagery in recent years in the~     individualization of different lesions in the nervous system for demyelination, axonal loss,~     atrophy, little progress has been made in the specific recognition the inflammatory process.~     Yet this point is essential since the currently available treatments have a partial impact~     mainly on the inflammatory component and that many uncertainties remain about the links~     between inflammation and tissue destruction affecting myelin and axons. The recent discovery~     of a macrophage cell marker in the CNS, more specific (USPIO) of inflammation gives us the~     opportunity to answer important questions which one can sense that this could have a~     significant impact on therapeutic drug monitoring of these patients. This study will involve~     50 patients recruited in five French centers (Marseille, Paris, Reims, Rennes, Toulouse) from~     the earliest manifestations of the disease with clinical and MRI scheduled for the first 3~     years of their disease.~   "
152727|NCT01567267|"~     The purpose of this study is to identify the effect of a short term educational intervention~     for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good~     Scientific Practice (GSP) to high-school biology students.~   "
152836|NCT01565850|"~     This study is to evaluate the safety and efficacy~     darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination~     (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir~     disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as~     determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.~   "
152707|NCT01567540|"~     Hepatitis C infection is a major public health problem with nearly 175 million infected~     individuals worldwide. Although cure is possible, only 20-40% of patients spontaneously~     resolve infection and 40-80% of chronically infected patients (numbers vary depending on~     viral genotype) that receive pegylated-interferon-alfa2a/ribavirin therapy clear the virus~     and are sustained virologic responders (SVR). Still for many, the virus manages to circumvent~     natural immunity and current therapeutic strategies, resulting in significant morbidity and~     mortality.~      To better define the distinct clinical outcomes of HCV infection many investigators have~     performed candidate molecules screens or transcriptional profiling in order to identify~     correlates of viral clearance. One molecule that has gained significant attention is CXCL10~     (also known as interferon-gamma induced protein-10 or IP-10) as an important negative~     prognostic biomarker. Given that CXCL10 is produced by hepatocytes and mediates~     chemo-attraction of activated lymphocytes expressing the CXCL10-receptor, CXCR3, it is~     counter-intuitive as to why this chemokine correlates with therapeutic non-responsiveness.~      The investigators hypothesized and have now demonstrated that CXCL10 is being cleaved in~     situ, resulting in the generation of an antagonist form of the chemokine. Based on the use of~     specific inhibitors, the investigators now propose to test whether protection of the agonist~     form of CXCL10 will increase responsiveness to peg-IFN-alfa2 / ribavirin therapy. This can be~     achieved using DPPIV inhibitors, targeting the enzyme responsible for N-terminal truncation~     of CXCL10. If safety is confirmed, the efficacy of DPPIV-inhibition in HCV patients will be~     tested in future trials that examine potential clearance benefits.~   "
152708|NCT01567527|"~     This will be a randomized, double-blind, placebo-controlled trial to assess the time to~     recurrence of any mood episode in subjects with bipolar I disorder who have maintained~     stability on aripiprazole IM depot for at least 8 weeks. This trial will include male and~     female subjects 18 to 65 years of age, inclusive, with a diagnosis of bipolar I disorder,~     according to DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric~     Interview (MINI), who have experienced at least one previous manic episode of sufficient~     severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic~     agent in addition to their current manic episode. All subjects must be experiencing a manic~     episode (per DSM-IV-TR criteria) with a YMRS total score ≥ 20 at trial entry. Both inpatients~     and outpatients are eligible for this trial.~      This trial will consist of a screening phase followed by 4 treatment phases. Subjects will~     undergo screening for eligibility, followed by a conversion to oral aripiprazole monotherapy~     phase, if needed, an oral aripiprazole stabilization phase, a single-blind aripiprazole IM~     depot stabilization phase, and, a double-blind, placebo-controlled phase.~   "
152709|NCT01567514|"~     The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on~     risk of pulpal complications in deep occlusal cavities with resin-based restorations.~   "
152710|NCT01567501|"~     This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this~     study is to assess the bioequivalence between Test Product and the corresponding Reference~     Product under fed condition in normal, healthy, adult, human subjects.~   "
152711|NCT01567488|"~     The underlying hypothesis of the synergistic activity of octreotide and everolimus is based~     on the combination of a) a direct action of everolimus over mTOR (mammalian target of~     rapamycin), and b) the inhibitory effect of octreotide on the IGF-I (insulin like growth~     factor 1) system preventing the activation of the mTOR system by this factor. Both types of~     inhibition would completely cancel this signal transduction pathway, which is so important in~     neuroendocrine tumours.~      Furthermore, the biological study proposed in this protocol will allow for better~     establishing the relationship between the activation of the IGFR-PI3K-mTOR signal~     transduction pathway (i.e., the mTOR pathway stimulated by IGFR) and treatment response; this~     information is relevant since the IGFR-PI3K-mTOR activation status could be a response~     prediction factor.~      This study will provide significant additional information about the efficacy of the~     combination treatment of everolimus with octreotide LAR® in non-functioning GI NET.~   "
152712|NCT01567475|"~     This study is an open label, multicenter study with two phases:~        -  Phase I is a dose escalation study of RAD001 in combination with one injection of~          Rituximab 375 mg/m² per week during 4 weeks (28 days) in patients CD20 positive~          non-Hodgkin's lymphomas to determine the dose limiting toxicities (DLTs) and maximum~          tolerated dose (MTD). The purpose of the study is to assess the feasibility of the~          combination based on - rate of dose limiting toxicities (DLT) and PK drug-drug~          interaction (DDI).~        -  Phase II will define the efficacy and safety profile of RAD001 and Rituximab combination~          at the RP2D in patients with lymphomas.~      Patients with lymphomas will be treated at the RP2D established during phase I and evaluated~     for clinical benefit rate, comprising complete responses (CR + CRu), partial responses (PR)~     and stable disease (SD), and time to progression using the IWG criteria for treatment~     response.~      Induction therapy will follow the same schedule than during the phase I study.~      Maintenance therapy: Monthly cycles for up to 2 years with:~        -  Daily RAD001 at the same dose than during induction therapy.~        -  Rituximab infusion every other cycle at 375 mg/m2 that correspond to the usual~          maintenance schedule for Rituximab.~      Response to therapy will be assessed between day 42 and day 49, then every two months.~   "
152713|NCT01567462|"~     The purpose of this study is to compare the use of two types of equipment during~     transurethral resection of bladder tumors (TURBT). The two types of surgical devices are: the~     monopolar loop electrocautery and the PlasmaKinetic (PK) Button Vaporization Electrode. These~     two devices do the same task but differ in the way they create electric current when removing~     cancerous tissue. The investigators hope to examine and compare the uses of these two~     surgical devices to see if any advantages do exist or whether they actually are similar. The~     goal of the study is to prove similarity in outcomes between the two techniques and analyze~     the outcomes resulting from each case.~   "
152714|NCT01567449|"~     The purpose of this study is to examine the risk factors for aneurysm rebleeding.~   "
152715|NCT01567436|"~     Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy~     as an HIV prevention intervention in randomized controlled trials (WHO and UNAIDS, 2007),~     based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported~     a protective effect of about 60%~   "
152874|NCT01565356|"~     This study will re-read 10-minute positron emission tomography (PET) scans acquired in~     previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the~     results.~   "
152716|NCT01567423|"~     In the Democratic Republic of Congo (DRC), malaria is an important cause of morbidity and~     mortality. It is estimated that malaria is responsible for 30% of admissions to hospital~     averaged throughout the country and for 25-30% mortality in children under five.~      In 2005, DRC adopted artesunate and amodiaquine (ASAQ) as first-line anti-malarial treatment.~     As WHO recommended that the efficacy of antimalarial drugs was monitored regularly to avoid~     an upsurge of mortality and morbidity due to continued use of ineffective drugs, a~     randomized, non-inferiority open-label trial was conducted in Katanga, in order to compare~     the efficacy of the fixed-dose formulation ASAQ versus artemether-lumefantrine (AL),~      Children aged six and 59 months with uncomplicated Plasmodium falciparum malaria were~     enrolledand randomly allocated into one of the two regimens. The risk of recurrent~     parasitaemia by day 42, both unadjusted and adjusted by PCR genotyping to distinguish~     recrudescence from new infection, was analysed.~      Between April 2008 and March 2009, 301 childrenwere included: 156 with ASAQ and 145 with AL.~     No early treatment failures were reported. Among the 256 patients followed-up at day 42, 32~     patients developed late clinical or parasitological failure (9.9% (13/131) in the ASAQ group~     and 15.2% (19/125) in the AL group). After PCR correction, cure rates were 98.3% (95%CI,~     94.1-99.8) in the ASAQ group and 99.1% (95%CI, 94.9-99.9) in the AL group (difference -0.7%,~     one sided 95%CI -3.1). Kaplan-Meier PCR-adjusted cure rates were similar. Both treatment~     regimens were generally well tolerated.~      Both ASAQ and AL are highly effective and currently adequate as the first-line treatment of~     uncomplicated falciparum malaria in this area of Katanga, DRC. However, in a very large~     country such as DRC, and because of possible emergence of resistance from other endemic~     regions, surveillance of efficacy of artemisinin-based combination treatments, including~     other evaluations of the resistance of ASAQ, need to be done in other provinces.~   "
152717|NCT01567410|"~     The purpose of this study is to determine wether e-learning is a more effective than~     traditional classroom teaching at norwegian nurses ability to use the Braden risk assessment~     scale and pressure ulcer classification.~   "
152718|NCT01567397|"~     Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to~     randomised controlled studies.While such studies are essential to determine efficacy and~     safety of the product (usually compared to placebo), they provide no information on the~     effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality~     of life and other patient-related outcomes) in the typical real-life setting under clinical~     practice conditions.Thus, the present study aims to collect data on the~        -  Drug utilization of Microbial Collagenase in the hand of physicians, with focus on~          feasibility, treatment patterns, and effectiveness in clinical practice~        -  Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant~          treatment, follow-up therapy)~        -  Effectiveness (with focus on functionality)~        -  Tolerability~        -  Patient-related outcomes: patient satisfaction, health-related quality of life~        -  Physician satisfaction with therapy~        -  Resource utilization (hospital stays, drug consumption, concomitant medication etc.)~        -  Long-term outcomes~   "
152719|NCT01567384|"~     The purpose of the study is to test the safety of an experimental drug called OSI-906 when~     combined with pemetrexed at different dose levels and to find out the optimal doses of the~     two drugs that can be given as a combination. Pemetrexed has been widely used for treatment~     of certain solid organ tumors and is effective and approved for use in treatment of lung~     cancer and mesothelioma.~   "
152720|NCT01567371|"~     This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid~     monitor) during a period of phlebotomy and graded blood loss in patients who are having~     cardiac surgery.~   "
152721|NCT01567358|"~     The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in~     patients with Rheumatoid Arthritis inadequately treated with Methotrexate.~   "
152722|NCT01567345|"~     The aim of this study is to compare intrathecal morphine administration: using a pump with~     continuous or programmable flow.~   "
152723|NCT01567332|"~     Recovery of neurological deficits after stroke results from a reorganization of cortical~     activities, possibly through brain plasticity. Repetitive Transcranial Magnetic Stimulation~     (rTMS-MagproR30) produces changes in cortical excitability, generates phenomena of~     neuroplasticity. Its use to improve function after stroke, particularly of the upper limb,~     was validated. The investigators propose to evaluate in a prospective pilot against placebo,~     the benefit of rTMS at low frequency (1Hz) on the unaffected hemisphere in the short and~     medium term, especially on walking function and spasticity in patients with sequelae of~     cerebral infarction in the MCA territory with gait disturbance and motor weakness of the~     upper limb.~   "
152724|NCT01567319|"~     Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic~     and non-allergenic components. Many factors such as the biovariability, differences in~     extraction process and subsequent handling of allergens can affect the final composition,~     potency, and stability of allergen preparations. Genetic diversity of affected people adds~     another level of complexity. In order to control variability and to achieve consistency and~     reproducibility for optimal safety and sensitivity/specificity, it is essential to~     standardize the amount of allergen used in prick tests. Therefore, the system for biological~     standardization mainly used in Europe still is the biological calibration of in-House~     Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines~     as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT)~     value. The aim of this procedure is to estimate the biological activity of allergen extracts.~     The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a~     specific skin reaction with a wheal of the same size as a wheal provoked by reference~     histamine at a concentration of 10 mg/ml, when both solutions are administrated using the~     same technique (prick testing) on at least 20 individuals who are sensitized to the allergen~     concerned.~      The present study aims to standardize the allergen extracts of Dactylis glomerata, Lolium~     perenne, Secale cereale y Olea europaea by using this method.~   "
152725|NCT01567306|"~     Based on EMA (European Medicines Agency) new guidelines on the clinical development of~     products for immunotherapy for the treatment of allergic diseases the aim of this study is to~     establish a dose-response relationship for clinical efficacy of Phleum pratense pollen~     extract subcutaneous vaccine.~   "
152749|NCT01566981|"~     The purpose of the study is to clinically evaluate a new approach to treatment of patients~     with diabetes mellitus type II by using specially developed mobile-internet software~     solution.~      The effect of information and communication technologies (ICT) to improve the integrated care~     of people with diabetes will be identified, developed, introduced and clinically evaluated.~      The investigators expect that usage of an e-Health application in health care of patients~     with diabetes mellitus type II could improve the following healthcare outcomes: results of~     the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood pressure~     values, Body mass index (BMI) values, diet, regular exercise and quality of life.~   "
152728|NCT01567254|"~     Background: Pediatric patients with type 1 diabetes mellitus are known to be a challenging~     group for achieving recommended glycemic control. Coping with the demands of self-managing~     IDDM in children and adolescents can be a formidable task, requiring a healthy and balanced~     diet, monitoring and regular insulin injections. Most patients are non-compliant to the~     treatment. A number of controlled studies have examined the efficiency of psychosocial~     interventions for improving compliance and glycemic control among diabetic youth. None has~     examined the effectiveness of guided imagery in treatment of type 1 diabetes mellitus.~      Primary Objective: To asses simultaneously the effect of listening to auditory guided imagery~     and blood glucose variability, compared to variability in blood glucose while listening to~     songs.~      Secondary Objective To assess the effect of routine auditory guided imagery to glycemic~     control and quality of life in children with type 1 diabetes mellitus, compared to listening~     listening to songs.~      Methods:~      Subjects: 14 youth ages 7-16 years with type 1 diabetes mellitus , for at least 6 months, and~     not during the honey moon period will be recruited, and will be blindly randomized to receive~     intervention (auditory guided imagery group) or control (regular auditory music).~      Protocol:~      Design: A randomized Controlled Blinded Study Intervention: 14 randomly numbered CD's will be~     prepared at study initiation, half containing auditory guided imagery and half containing~     music.~      Study protocol: After an initial check up, including HbA1C levels, and explanation of study~     procedures the participants will be given either the intervention or the control CD, to be~     used twice a day for five days. During this period continuous glucose monitoring will be~     performed. On days one and five the procedure will take place while the participants are~     connected to biofeedback. QOL questionnaires will be completed at the beginning of day one,~     or before.~      In the second part of the study the children will use the intervention / control CD at home~     twice a week for 12 weeks. At the end of the study period they will again be evaluated,~     including HbA1C, and all subjects will again complete QOL questionnaires~   "
152729|NCT01567241|"~     Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction~     techniques are required?~   "
152730|NCT01567228|"~     Physician counseling for physical activity, dental services, and academic support services~     such as tutoring could be improved through physician knowledge of local community resources~     and physician counseling directing patients to such services that are near the patient's~     residential address. This study will test the hypothesis that an electronic medical record~     enhanced with geographic information systems can improved physician counseling for physical~     activity, dental services, and academic support services by identifying services that are~     near the patient's residential address and informing MD's of such info at the point of care.~   "
152731|NCT01567215|"~     The investigators want to show that steroid creme and even better alcohol swaps are just as~     effective or equal to the current treatment with silver nitrate of granuloma umbilical in~     newborns.~   "
152732|NCT01567202|"~     This is a Phase II study in a single center to determine the efficacy of autologous dendritic~     cells (DCs) loaded with autogeneic glioma stem-like cells (A2B5+) administered as a~     vaccination in adults with glioblastoma multiforme (primary or secondary).~   "
152733|NCT01567189|"~     The hypothesis is that home based clinical rehabilitation (CR) is less expensive than~     hospital based CR with similar clinical effectiveness. The investigators will compare the~     results of two forms of CR on~        1. direct and indirect healthcare costs~        2. effectiveness on mortality, morbidity, modifiable risk factors control, functional~          capacity measured by exercise testing, health related quality of life and satisfaction~          rate~        3. cost/effectiveness analysis~   "
152734|NCT01567176|"~     This study follows the results of the COMPALICLAMP study (NCT00951392) where the~     investigators showed a differential expression of sirtuins protein isoforms, Sirt6, in muscle~     depending on the quality of aging. The investigators seek to confirm this difference in~     expression level of circulating leukocytes on a larger sample.~   "
152735|NCT01567163|"~     The purpose of this study is to assess the effect of concomitant ramucirumab on the~     pharmacokinetics of docetaxel in participants with advanced malignant solid tumors.~      Participants who do not complete both Cycle 1, Day 1, and Cycle 2, Day 1 according to~     schedule will be replaced for the purpose of analysis; these participants may continue to~     receive study therapy. No dose reductions, delayed or missed doses are allowed during Cycles~     1 and 2.~   "
152736|NCT01567150|"~     This study is being conducted to characterize the way leg wounds respond to a new type of~     wound dressing, compared to wounds in patients who are not using the new dressing. The~     investigators will collect wound fluid for biochemical analysis, and they will measure the~     wound healing that occurs with and without the new dressing.~   "
152737|NCT01567137|"~     Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in~     detecting, localising and characterising satellite lesions in relation to an index breast~     tumour in order to improve definition of clinical target volume after local excision.~      Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for~     localising unsuspected multifocal and multicentric lesions in women diagnosed with early~     breast cancer.~   "
152738|NCT01567124|"~     The use of antipsychotic medications has increased over the past decade. While more recently~     developed medications are improved with regards to extrapyramidal side effects, the use of~     atypical antipsychotics has been associated with substantial weight gain and a worsening of~     metabolic profile. The time course and extent of weight gain differs among antipsychotics,~     with olanzapine and clozapine being associated with greatest weight gain.~      Mechanisms underlying a worsening metabolic profile, obesity and obesity-related illnesses~     are complex, extending beyond sedentary lifestyle, poor diet and genetic predisposition.~     There is also a growing body of evidence that the sympathetic nervous system (SNS) has a role~     in the generation of both obesity and obesity-related illness. While the role of the SNS in~     blood pressure control is readily acknowledged it is less well appreciated that activation of~     the SNS exerts profound metabolic effects.~      Although the fact of a causal relation linking antipsychotic drugs and obesity is~     unequivocally established, the biological mechanisms operating are unclear, and strategies~     for preventive therapy remain largely unformulated.~      This study aims to investigate the role of the SNS and its association with the metabolic~     abnormalities that are frequently observed in patients with schizophrenia following treatment~     with antipsychotic medications.~      Additionally, the study will investigate whether treatment with the centrally acting~     sympatholytic agent moxonidine will modify SNS activity and, hence, favourably influence the~     downstream metabolic abnormalities seen in antipsychotic treated patients with schizophrenia.~      Hypothesis 1: Elevated sympathetic nervous system activity underlies the metabolic~     disturbances observed in patients following antipsychotic therapy.~      Aim 1: To investigate the role of the sympathetic nervous system and its association with the~     metabolic abnormalities that are frequently observed in patients with schizophrenia following~     treatment with antipsychotic medications~      Hypothesis 2: Central sympathoinhibition with moxonidine will blunt the elevated sympathetic~     nervous activity and downstream metabolic abnormalities observed in antipsychotic treated~     patients with schizophrenia.~      Aim 2: Determine whether treatment with the centrally acting sympatholytic agent moxonidine~     will modify sympathetic nervous system activity and, hence, favourably influence the~     downstream metabolic abnormalities seen in antipsychotic treated patients with schizophrenia.~   "
152750|NCT01566968|"~     The sensitivity of a person's cough reflex can be measured by getting them to breathe in~     (inhale) irritant chemicals. There are different methods by which subjects are asked to~     inhale these chemicals, either by taking one deep breath in, or by asking them to just~     continue to take a number of breaths. The purpose of this clinical research study is to see~     if the coughing responses are different in healthy people and people with respiratory~     problems that make them cough when they are given these chemicals in these two methods.~   "
152823|NCT01566019|"~     The primary objective of the study is to use high throughput molecular analysis (CGH Array~     and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order~     to improve the progression free survival compared to the previous treatment line.~      The secondary objectives are to investigate clinical practical feasibility of such technics,~     to potentially improve the overall survival of patients and to describe molecular portrait of~     Phase 1 candidates.~   "
152739|NCT01567111|"~     Rationale: Primary hyperaldosteronism (PA) is the most frequent and possibly curable form of~     secondary hypertension. The diagnosis and targeted treatment of PA is essential because of~     high vascular morbidity associated with PA as compared to essential hypertension with~     comparable blood pressure levels. PA is usually caused by either a unilateral~     aldosterone-producing adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction~     between APA and BAH is critical since the former may be cured by adrenalectomy, and the~     latter needs life-long medical therapy with mineralocorticoid receptor antagonists (MRA).~     Studies demonstrate that adrenalectomy benefits also BAH patients with dominant nodule(s)~     producing the most of aldosterone excess. The distinction between unilateral and bilateral PA~     can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008~     guideline. Currently, in Finland the diagnosis is based on computed tomography (CT) scanning~     which does not distinguish between aldosterone-producing and common non-functioning adrenal~     nodules and has limited accuracy detecting small adrenal masses. Since AVS is invasive,~     dependent on skilled radiologist and costly, there is a need for an accurate, non-invasive~     functional imaging such as 11C-metomidate positron emission tomography (MTO-PET).~      Objective: To assess diagnostic ability of MTO-PET as compared to AVS in PA. Secondary~     objectives: To compare if standardized uptake values (SUVs)in MTO-PET imaging are similar in~     histologically diagnosed nodular hyperplasia versus adenoma. To assess the diagnostic~     accuracy of adrenal CT as compared to MTO-PET and AVS. To assess the complete and partial~     remission rates (blood pressure response expressed in Daily Defined Dosages, medical therapy,~     use of potassium supplements) after allocating subjects to MRA-therapy or adrenalectomy at 1~     and 5 years.~   "
152740|NCT01567098|"~     A randomized trial to study the null hypothesis: single incision appendectomy does not take~     longer operation time when compared to conventional 3-port appendectomy. The study will be~     carried out in a tertiary referral center in Hong Kong with a catchment population of 1~     million.~   "
152741|NCT01567085|"~     Primary Objective:~      To evaluate the safety and potential efficacy of eculizumab to prevent Antibody Mediated~     Rejection (AMR) in sensitized recipients of deceased donor kidney transplants.~   "
152742|NCT01567072|"~     It is believed, that Non Steroidal Antiinflammatory Drug (NSAID) drugs slows bone healing,~     but the knowledge is based only on animal studies, and the results are automatically raised~     for the people.~      Many patients with bone fracture must therefore avoid the formerly so popular and good~     painkillers, although no clinical trial evidence is, that this medicine is really harmful for~     patients with fractures.~      The purpose of this study is to investigate whether these drugs slows bone healing, and what~     the relationship is between various bone studies - DEXA scanning, biochemical bone marker~     tests, radiographic controls and tissue examination of newly formed bone under a microscope.~     How sensitive and specific, each of the above study methods? If they are just as sensitive,~     the cheapest of them recommended as a routine investigation on suspicion of bone effects.~     Furthermore, to compare the benefit (pain-relieving effect, influence on rehabilitation) of~     these drugs and their possible harmful side effects (affected and delayed bone healing).~      The expectation is that the study may contribute to increased knowledge about NSAIDs effect~     do pain management, rehabilitation and the entire treatment process significantly easier and~     safer, so that patients recover faster and return to usual activities.~   "
152743|NCT01567059|"~     This study examines a new oral chemotherapy drug called tosedostat, in combination with~     cytarabine or decitabine. Tosedostat is thought to work by decreasing the availability of~     amino acids (building blocks the cell needs to make proteins) in cells. It has been shown in~     early studies to have activity against a variety of cancers, including leukemias. Patients~     with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with specific~     genetic mutations have a poorer response to chemotherapy and a higher risk of relapse after~     treatment. Researchers are looking to see if combinations of chemotherapy drugs may improve~     outcomes for patients that do not respond as well with the current chemotherapy regimens,~     without increasing the risks of treatment.~   "
152744|NCT01567046|"~     This research trial studies genes in tissue samples from younger and adolescent patients with~     soft tissue sarcomas. Studying samples of tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat cancer~   "
152745|NCT01567033|"~     The purpose of this research study is to evaluate two different Parents as Teachers~     curriculums taught by parent educators, during home visits. The control curriculum includes~     only the standard PAT lessons; the intervention curriculum includes the standard PAT lessons~     plus additional information about how families can live healthy and active lives while~     reaching a healthy weight. The investigators hypothesize the intervention lessons will change~     the way people eat and/or their activity level.~   "
152746|NCT01567020|"~     The current conflicts in Afghanistan and Iraq have resulted in unprecedented rates of~     exposure to high-intensity blasts and resulting brain injury. This research team has~     established that recently blast-exposed Soldiers show differences from controls on tests of~     central auditory function. This project will 1) develop a more accurate estimate of the~     prevalence of central auditory dysfunction among Veterans exposed to blasts over the past ten~     years, 2) identify the functional outcomes associated with abnormal performance on tests of~     central processing, and 3) improve understanding of the ways in which blast-exposure~     resembles and differs from both the normal aging process and non-blast-related TBI in terms~     of performance on tests of central auditory processing.~   "
152747|NCT01567007|"~     The purpose of this study is to evaluate the impact of different types of intervention on~     physical activity level and co-morbidities in women workers aged between 40 and 50 years.~     Method: A total of 195 sedentary women aged between 40 and 50 years and those who agreed to~     participate were randomized to one of the following interventions: GI = Control (n = 47), GII~     = Individual counseling (n = 53), GIII = Counseling group (n = 48); GIV = physical training~     set (n = 47). Were evaluated: Physical Activity level (steps number evaluated by a~     pedometer), quality of life (SF-36), body composition (BMI, waist circumference and~     bioelectrical impedance) and clinical variables (plasma glucose and blood pressure).~   "
152748|NCT01566994|"~     If the treatment combining Motivation Enhancement, Reduction Counseling, Nicotine Replacement~     Therapy and Transtheoretical tailored interventions produces an increasing treatment~     trajectory, it will produce unprecedented impacts with unmotivated smokers specifically and~     population cessation generally. These recruitment and intervention strategies require limited~     resources from health care providers and could be readily disseminable to other health care~     systems for application with populations of smokers, especially unmotivated smokers who have~     been understudied and underserved.~   "
152835|NCT01565863|"~     The purpose of this study is to test the effectiveness of the Progressive Goal Attainment~     Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans~     with disabilities.~   "
152751|NCT01566955|"~     The main reason for this trial is to show the feasibility of removing the ovarien and~     fallopian tubes through the gaster (transgastric adnexectomy). The background for it is to~     look for more indications of scarless surgery and we will show that the transgastric~     adnexectomy can be performed in an easy way. It is necessary that there is an indication for~     removing the ovaries and fallopian tubes and if the patient agree we will do it instead of~     through the belly through the gaster and maybe with an additional inzision in the vagina. All~     patients with indication for adnexectomy are potential candidates.~   "
152752|NCT01566942|"~     the aim of this study is to observe the effect of irinotecan-based regimen in patients with~     advanced colorectal cancer.~   "
152753|NCT01566929|"~     The primary aim of the study is to evaluate if weight management intervention for obese women~     (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating~     woman, as compared to women where no intervention was made.~   "
152754|NCT01566916|"~     This prospective, randomized study will study the 2 year survivorship and short term outcomes~     of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two~     surgical approaches. The surgical approaches being studied are direct anterior and~     anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will~     be compared. Subjects will be randomized to surgical approach and followed for a period of~     two years.~   "
152755|NCT01566903|"~     MR angiography (MRA) has become essential in the treatment of neurovascular diseases,~     including ischemic stroke - the first cause of disability in occidental countries, vascular~     malformations such as aneurysms, arteriovenous fistulas and malformations, whose treatments~     are improving year after year.~      MRA is an alternative to digital substracted angiography (DSA), circumventing th use of~     endovascular catheterism, irradiation and injection of iodinated contrast agent.~     Contrast-Enhanced MRA (CE-MRA) with gadolinium injection is currently the reference standard~     for vascular MR exploration but still presents many limitations inherent to the injection of~     contrast medium. Hence, the synchronization of the acquisition with bolus contrast injection~     limits the improvement of spatial and temporal resolutions and requires an accurate~     synchronization of the acquisition with the arrival of the bolus.~      Moreover, the acquisition can be repeated as required as it does not require any contrast~     injection.~      Besides, the increase in nephrogenic systematic fibrosis clinical cases, which would be~     secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has~     restricted the use of CE-MRA. More than 500 cases were described to date in the world.~      Its occurrence is currently estimated around 4 % for patients in terminal chronic renal~     insufficiency and its mortality around 30 %.~      According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agent~     (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST~     *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30~     ml/mn.~      Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide~     complete and non-invasive investigation of the vasculature, thus offering patients with~     chronic renal insufficiency, as well as pregnant or nursing women a surrogate with no side~     effects.~      Moreover, the use of high field (3T) MR imaging offers improved signal to noise ratio.~     Combined with the use of phased array coils and parallel imaging, new NCE MRA sequences can~     achieve juxta-millimeter isotropic spatial resolution and temporal resolution of about 50 ms~     close to those of cerebral DSA.~      These sequences allow a joint hemodynamical and morphological assessment of lesions, both at~     the cervical and cerebral levels, whether at diagnosis or during patient follow-up~   "
152756|NCT01566890|"~     Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to~     change their shape from a round shape to a half-moon/crescent or sickled shape. Sickle-shaped~     cells can cause problems by getting stuck in blood vessels, blocking blood flow, and can~     cause inflammation and injury to important body parts. There are no specific treatments that~     improve this condition and promote blood flow hindered by sickle cell blockages. Another big~     challenge in managing sickle cell disease is that there are no good measures to determine~     changes and improvements in blood flow.~      Contrast-enhanced ultrasound is a technique currently used to detect blood flow in the heart,~     muscles, and other organs. It is extremely sensitive and can detect blood flow in the~     smallest of blood vessels. It would be very useful in helping healthcare providers know~     whether treatment strategies are improving blood flow during sickle cell blockages.~      The hypothesis is that contrast-enhanced ultrasound will be a feasible tool for determining~     changes in blood flow of subjects with sickle cell disease.~   "
152757|NCT01566877|"~     The purpose of this study is to evaluate the safety and tolerability of healthy male and~     female subjects with intravenous (IV) infusions of AVI 7288 compared to matched placebo in~     and to evaluate the pharmacokinetics (PK).~   "
152758|NCT01566864|"~     The investigators have designed a three-part quality improvement intervention to 1) improve~     the clinic-based measurement of blood pressure, 2) introduce a care management system to~     promote self-management behaviors and rapidly titrate medications by algorithms developed in~     accord with guidelines and 3) introduce an interactive, needs-based, longitudinal-provider~     education system that promotes patient-centered care and provides practical examples of~     patient-provider communication strategies. The intervention will occur at six clinics within~     the metropolitan area of Baltimore, Maryland. The investigators will also describe clinic and~     health system characteristics and measure their association with implementation (uptake),~     success (improvements in blood pressure control and reductions in racial disparities), and~     sustainability of the three-part intervention over 12 -24 months.~   "
152759|NCT01566851|"~     Introduction Cardiovascular diseases are the first cause of death in rheumatoid arthritis~     (RA). In 2010, EULAR Standing Committee for Clinical Affairs provides 10 recommendations for~     cardiovascular risk management in patients with rheumatoid arthritis, including a~     cardiovascular risk assessment annually.~      The goal of this study is to evaluate the application of EULAR recommendations in real life~     in patients with RA in the french population. Inclusion criteria: all patients over 18 years~     old with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy,~     affiliated to the RSI (regime social des independents which correspond to other branches of~     the universal healthcare insurance agency). Non inclusion criteria: patients declared as~     rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone. The~     following analysis will be performed on the whole database of the RSI, without name~     identification. Evaluation criteria: at least once a years the prescription of at least one~     of the following items use in the evaluation of the cardiovascular risk factors: lipides~     dosage, glycemia, HbA1C, stress test, Carotid ultra-sonography, coronary or lower limbs~     arteriography, heart ultra-sonography, cardiology clinic, endocrinology clinic. This~     evaluation will be done on the whole national population of RSI for the year 2011 (01/01/2011~     - 31/12/2011). On a subgroup of patients from the region Provence Alpes Côte d'Azur, the~     investigators will analyze the year 2009, and compare to year 2011, to evaluate the impact of~     theses recommendations.~   "
161209|NCT01455896|"~     Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated~     with ITCA 650.~   "
152760|NCT01566838|"~     Rationale: For the past 3 years the investigators have routinely used an axial subpleural~     tunneling technique that del~      Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure~     performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screened.~     Patients will be excluded if they have: previous ipsilateral thoracic surgery, need for~     operative pleurectomy or pleurodesis, chronic use of pain medication, sedatives or hypnotics,~     drug allergies, liver dysfunction, renal dysfunction, history of peptic ulcerative disease,~     sleep apnea in need of Bipap, severe chronic obstructive pulmonary disease (COPD), inability~     to consent, or are pregnant. All patients included will be screened, consented, and operated~     on by the one year anniversary of institutional review board (IRB) approval.~      Study Methodology: Eighty-six consented patients will be randomized into the study arm (use~     of a pain catheter with 0.125% bupivacaine) or the standard of care group (no pain catheter).~     The primary outcome is the use of narcotic pain medication post-operatively, compared between~     study groups. Secondary outcomes will include postoperative pain scores, hospital and length~     of stay.~      The On-Q pump delivers local anesthetic to the intercostal space, without leakage elsewhere,~     creating a functional multi level rib block. Despite positive subjective results, objective~     data is lacking. The investigators have also noted that some patients develop an annoying~     short term paresthesia that has been minimized by using lower anesthetic concentrations than~     described in other publications.~      Objectives: To evaluate visual analog pain scores post-operatively up to 30 days~     post-operative, and to determine any association between pain management and length of stay.~      Study Type: A prospective randomized 2-arm study will be performed. Statistical Methodology:~     Total amount of narcotic pain medication administered through postoperative day 7, will be~     compared between the study groups using student's t-tests and Wilcoxon rank-sum tests.~     Secondary outcomes, overall sum of pain scores through postoperative day 7, then at day 30~     post-operatively, hospital length of stay, and overall hospital cost, will also be compared~     among study groups using student's t-tests and Wilcoxon rank-sum tests.~   "
152761|NCT01566825|"~     The purpose of this study is to determine whether 75 mg amitriptyline affect the sleep~     dependent consolidation of procedural memory (visual discrimination task,~     Karni-Sagi-paradigm).~   "
152762|NCT01566812|"~     This study aims to find out whether breast feeding optimization will increase breast feeding~     rates and to evaluate its effect on cardiovascular risk and general health of children.~   "
152763|NCT01566799|"~     Background Obesity and overweight are well known risk factors for breast cancer and also are~     associated with higher recurrence and mortality rates.~      Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms~     of pathologic complete response in comparison with placebo plus the same chemotherapy regimen~     Design: Randomized, double blind, clinical trial. This study will be performed at National~     Cancer Institute of Mexico City, at breast cancer unit.~      Patients with ER+ or PR+, HER2 negative, breast cancer are candidates to participate.~      After completion of chemotherapy all patients will have a breast surgery to assess pathologic~     response.~      Complete pathologic response is defined as the abscence of malignant cells in breast tissue~     and lymph nodes. The presence of DCIS is considered as pCR~   "
152764|NCT01566786|"~     This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the~     safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in~     preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).~   "
152765|NCT01566773|"~     The overall objective of this study is to determine an optimal dose and dosing regimen of~     PT001 MDI for further evaluation in later stage studies.~   "
152766|NCT01566760|"~     This is an open-label (both the physician and healthy volunteer know which medication will be~     administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics~     (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by~     the body) and the effects of food on the pharmacokinetics of the drug. This study will take~     place over approximately 8 weeks and will consist of a screening visit to determine~     eligibility for the study, and 2- or 3-period treatment phase for each cohort.~   "
152767|NCT01566747|"~     This is a phase II open label, single arm study evaluating treatment with pazopanib post~     sunitinib treatment in 43 patients with metastatic renal cell carcinoma. Patients will~     receive 800mg pazopanib per day given continuously until disease progression. Patients must~     have received treatment with sunitinib and relapsed. Patient must have received prior~     treatment with sunitinib for at least 12 weeks. Prior treatment with either temsirolimus or~     everolimus in addition to sunitinib is allowed. The trial design uses a Simons two stage~     design with an interim analysis planned after the first 15 evaluable patients. If 8 or more~     of the first 15 evaluable patients remains disease free at 4 months, then a further 28~     patients will be enrolled for a total of 43 metastatic renal cell cancer patients. It is~     estimated that there could be up to 10% of patients dropping out and so to achieve the~     required number of 43 evaluable patients the study will recruit up to 48 patients to ensure~     that 43 complete if stage 2 is required.~      Patients will receive treatment until disease progression, unacceptable toxicity or~     withdrawal of patient consent. Response assessments will be carried out every 8 weeks until~     disease progression. Safety assessments will be carried out every 4 weeks (plus a visit for~     liver function tests after 2 weeks) for the first six months and then every eight weeks until~     disease progression. A further safety assessment will be carried out 4 weeks after treatment~     discontinuation.~   "
152768|NCT01566734|"~     This study conducted to assess the effects of normal saline or cefazolin irrigation on the~     incidence of SSIs.~      Hypothesis:~      Normal saline or cefazolin irrigation decreases the incidence of SSIs.~   "
152769|NCT01566721|"~     This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and~     tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in~     participants with early HER2-positive breast cancer following tumor excision. Participants~     will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an~     assisted administration using a conventional syringe and needle/vial formulation (Cohort A)~     or with assisted and self-administration using a single-use injection device (SID) in~     selected participants (Cohort B).~   "
152770|NCT01566708|"~     To date, the pharmacological treatment options for tinnitus are unsatisfactory. For acute~     tinnitus drug treatments are only rated as being successful in approximately half of all~     cases. Therefore, the purpose of this study is to evaluate a neuro-music therapeutic approach~     (the Heidelberg Model of Music Therapy) as a new treatment option for patients with recent~     onset tinnitus after initial medical treatment has failed.~   "
152771|NCT01566695|"~     Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus~     Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent~     anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk~     myelodysplastic syndromes (MDS).~   "
152875|NCT01565343|"~     This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy~     volunteers provide the same results. The study will also test two different AV-45 injection~     methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).~   "
152772|NCT01566682|"~     The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in~     the risk stratification of patients with pulmonary lesions identified by CT that are~     suspicious for lung cancer. A statistically significant result will indicate that patients~     with a high ProLung Test result have a greater risk of developing lung cancer than patients~     with a low test result.~      There are three Specific Aims of this study:~        1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in~          patients with a diagnosis.~        2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by~          comparing the test result to the conclusive patient diagnosis.~        3. Assess the safety and tolerability of the ProLung Test procedures.~      Study Design This Study consists of two distinct phases, Stabilization and Validation. The~     Study will collect data from multiple sites (3 to 12), and each site may enroll patients and~     collect data for the Stabilization and Validation Phases with a minimum of three sites for~     the Validation Phase.~   "
152773|NCT01566669|"~     The purpose of this study is to determine the effects of parecoxib in combination with~     epidural morphine in providing analgesia for patients undergoing gynecological surgery.~   "
152774|NCT01566656|"~     Recent advances in allogeneic hematopoietic cell transplantation (allo-SCT) have led to~     reduce intensity preparative regimens that are non-myeloablative and reduce the toxicities~     associated with the transplant. Consequently non-relapse mortality has been reduced,~     including in elderly patients with comorbidities. However, despite this benefit in terms of~     toxicity, excessive reduction of the intensity preparative regimens may favor relapse of the~     initial illness. Thus, acute and chronic graft-versus-host disease and opportunistic fungal~     and viral infections are always serious complications. The aim of our study is to check if a~     new modality of reduced intensity preparative regimen combining total lymphoid irradiation~     (TLI) and thymoglobulin (ATG), would limit the toxicity of treatment and reduce the incidence~     of acute GVHD after allogeneic transplantation while preserving the antitumor benefit.~   "
152775|NCT01566643|"~     This prospective controlled randomized open-label clinical trial is designed to determine the~     optimal eradication rate of rabeprazole based sequential-concommitant hybrid therapies for~     adults infected with Helicobacter pylori in Eastern Taiwan. Enrolled patients will receive 3,~     5 or 7 days of pre-concommitant (sequential part) treatment with rabeprazole + amoxicillin,~     then 7 days of concommitant treatment with rabeprazole + amoxicillin + clarithromycin +~     metronidazole.~   "
152776|NCT01566630|"~     This study is designed in two parts. Part 1 will assess the safety and tolerability of~     different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood~     pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can~     prolong pregnancy in women with pre-eclampsia.~   "
152777|NCT01566617|"~     The investigators hypothesize that pharmaceutical care may constitute an important tool for~     the clinical management of these patients by improving their compliance to their treatment~     with consequent improvement in their quality of life by minimizing symptoms, and decreasing~     the number of hospital admissions and adverse drug reactions. Therefore, the aim of this~     trial is to evaluate the contribution of pharmaceutical care to clinical treatment of~     patients with Chagas heart disease complicated by heart failure.~      Study Type: Interventional~      Study Design: A total of 88 patients will be randomly assigned into two parallel groups: (1)~     group who will receive standard care and pharmaceutical care; and (2) group who will receive~     only standard care. Both groups will be subjected to a follow-up period of 12 months. The~     primary outcome of this trial is the evaluation of quality of life, measured by the 36-item~     short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes~     include drug-related problems and exercise tolerance measured by the standard six-minute walk~     test.~   "
152778|NCT01566604|"~     This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237~     in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks~     treatment.~   "
152779|NCT01566591|"~     The purpose of the study is to evaluate the efficacy and safety of H1-Coil deep brain rTMS in~     subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully~     treated with antidepressant medications.~   "
152780|NCT01566578|"~     Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.~   "
152781|NCT01566565|"~     This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with~     the primary objective of testing the safety and tolerability of combined oral doses of~     theophylline and bambuterol in healthy human subjects. The secondary objective is to assess~     the pharmacokinetic profiles of theophylline and bambuterol when administered alone or in~     combination. It is hypothesized that the combination of these drugs is generally safe, and~     that no drug interaction can be observed.~   "
152782|NCT01566552|"~     The study is designed to determine the use of delivering point of care, rapid diagnosis with~     rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary~     Health Center (PHC) settings with regard to operational feasibility, safety and final cure~     rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the~     PHC level would bring the best available interventions closer to the patients with visceral~     leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would~     support the VL elimination program in the Indian subcontinent.~   "
152783|NCT01566539|"~     The project has three overall objectives. The first is to determine whether and how~     administration of intranasal oxytocin (OT) and intranasal vasopressin (AVP) influence~     cooperative decision-making and neural responses to cooperative and un-cooperative social~     interactions. The second is to determine whether and how intranasal vasopressin influences~     subjective evaluations of and neural responses to same and opposite-sex face stimuli and to~     determine if any of these effects persist beyond the period of AVP exposure. The third~     objective is to determine if intranasal OT influences empathy-related behavior and associated~     brain activity.~   "
152784|NCT01566526|"~     The purpose of this study is to use retrospective data to evaluate the efficacy, safety and~     re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein~     occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs~     Program.~   "
152876|NCT01565330|"~     This study will test two different doses of florbetapir F 18 to determine which dose is best~     to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron~     emission tomography (PET) scanner.~   "
152785|NCT01566513|"~     The current study, through a randomized controlled design, will evaluate the effectiveness of~     peer support, as compared to usual care and to an equivalent amount of support offered by~     peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions~     and in promoting recovery and community inclusion among adults with mental illnesses with~     histories of multiple hospitalizations. The current study evaluates the cost-effectiveness of~     adding peer support to the array of services available to persons with serious mental~     illnesses who have histories of multiple hospitalizations and will test a theoretical model~     of the active ingredients of peer support, focusing specifically on the roles of 1)~     instillation of hope through positive self-disclosure; 2) role modeling of self-care and~     exploring new ways of using experiential knowledge; and 3) a trusting relationship~     characterized by acceptance, understanding, and empathy with conditional regard.~   "
152786|NCT01566500|"~     There is an urgent need to understand the psychological and situational factors that~     influence medication adherence in individuals with epilepsy. According to the Center for~     Disease Control (CDC, 2010) about 2.5 million people in the United States have epilepsy and~     one third of them still have seizures despite receiving treatment. With proper medication, an~     estimated 60-70% of individuals with new onset epilepsy become, and remain, seizure free~     (Kwan & Brodie, 2000). Despite the success of medical treatment of epilepsy, many patients do~     not receive these benefits due to inadequate adherence to medication (Meyer et al., 2010).~     And, as with other chronic medical conditions, estimates suggest that between 30% and 60% of~     patients with epilepsy are not adherent with their drug regimens (Green & Simons Morton,~     1988; Leppik, 1990; Jones et al., 2006). Poor adherence may be the most important cause of~     poorly controlled epilepsy (Gomes et al., 1998). Stanaway et al. (1985) found that 31% of~     seizures were precipitated by nonadherence to medication.~      Questions regarding adherence are theoretically informed by Fisher et al. (2006)'s~     Information Motivation Behavioral Skills (IMB) model. While originally developed to describe,~     predict, and inform interventions for antiretroviral treatment for human immunodeficiency~     virus (HIV), this study applies the model to epilepsy for the first time. In addition, this~     study intends to produce an accurate description of how individuals with epilepsy manage~     their medication adherence by identifying current self regulation strategies (immediate~     adherence behaviors, preparatory behaviors, and barrier management strategies) and their~     situational determinants. Situational determinants can explain some of the fluctuations in~     medication adherence. Patients who are motivated to take their medications might still show~     inconsistent medication adherence. For example, patients might miss good opportunities to~     take their medication or fail to anticipate unexpected barriers such as a spontaneous dinner~     with friends or a bout of depression. Therefore, the study will take particular care to~     investigate situational cues such as good opportunities for adherence (e.g., taking~     medication with regular meals or before brushing teeth) and expected and unexpected barriers.~     Preparatory behaviors and their cues are also of interest in this study: Some patients use~     facilitators (such as physical or electronic reminder systems, electronic pill bottles and~     pill boxes) to ensure adequate medication adherence. Social support can serve a similar~     function of reminding patients to take their medication. To address these questions, the~     investigators plan to explore how individual regulation and social support influence~     medication adherence in patients with epilepsy. The specific aims of the proposed research~     are:~        1. To test the hypothesis that there will be a main effect of information, motivation and~          behavioral skills, on adherence behavior, and that a mediation model will show that~          information and motivation effects are partially mediated through behavioral skills.~        2. To identify self regulation strategies and their situational cues (good opportunities,~          facilitators, and barriers) for medication adherence among individuals with epilepsy to~          better describe best practices and challenges.~   "
152787|NCT01566487|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,~     crossover, multicentric experimental bioequivalence study.~   "
152788|NCT01566474|"~     The study consists on determining whether melatonin decreases oxidative stress in Barrett's~     esophageal mucosa after 6 months of treatment. In order to achieve the clinical trial, the~     patients will be randomized to two possible arms: omeprazole alone or omeprazole plus~     melatonin. The patients will be followed around four visits during six months.~      GERD is one of the most prevalent pathologies in the digestive tract. Barrett's esophagus, a~     complication of chronic GERD, has attracted the attention of researchers due to its condition~     of pre-neoplastic lesion. At present, treatment of Barrett's patients is limited to acid~     inhibition with PPIs. Although there are several studies which indicate that treatment with~     PPIs could decrease the incidence of high grade dysplasia and EAC, treatment with PPIs does~     not eliminate the risk of EAC in these patients. Therefore, it is necessary to find~     chemo-preventive agents that stop neoplastic progression of Barrett's esophagus. Among them,~     antioxidants have become the most promising agent. This pilot study will determine the~     efficacy of melatonin in the chemoprevention of EAC.~      So, the main objective of this study is to determine whether melatonin decreases oxidative~     stress in Barrett's esophageal mucosa after 6 months of treatment.~      To evaluate whether melatonin modifies other mechanisms associated to neoplastic progression~     in BE patients: proliferation and apoptotic index and molecular markers of progression:~     17pLOH, 9pLOH, p16 methylation and DNA ploidy (tetraploidy and/or aneuploidy).~   "
152789|NCT01566461|"~     The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral~     drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral~     arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.~   "
152790|NCT01566448|"~     Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when~     chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of~     patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of~     the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because~     the pain from mucositis can be so bad it can cause the inability to eat or drink, inability~     to talk, gagging and drooling. Many times mucositis can affect cancer treatment because~     patients may have to be given a lower dose of a drug or stop treatment completely. There are~     not many treatments today that can help relieve the severe pain caused from mucositis. This~     research study will help researchers determine if using an oral mouthwash called Ketamine~     will help lessen mucositis pain.~      Ketamine is approved by the Food and Drug Administration (FDA) for use with general~     anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a~     standard treatment option for mucositis pain.~      During this study patients will be assessed to determine the level of pain caused by their~     mucositis. This will occur before the first dose, one hour after the first dose, and then~     daily until they are no longer on the study. Patients will use the mouthwash by swishing and~     spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will~     use the mouthwash on this study until their mucositis gets better or until the mucositis gets~     worse (or if the pain does not get better after three days of treatment).~   "
152791|NCT01566435|"~     This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF)~     consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel),~     cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage~     III-IV squamous cell cancer of the head and neck. ACF may be an effective way to reduce or~     downgrade locally aggressive tumors, and improve the chance of eradication by chemoradiation.~   "
152792|NCT01566422|"~     Despite the use of prophylactic systemic antibiotics and improved surgical technique,~     surgical site infections remain a serious concern. The incidence of deep infection after~     spine surgery has been lowered with systemic antibiotics, yet after instrumented fusion for~     traumatic injuries infection rates remain as high as 10%. The impact on patients and cost of~     treating such infections is profound. With diminishing healthcare dollars and policy that~     refuses to reimburse for postoperative infections, it is critical that physicians and~     hospital systems seek out cost effective ways of decreasing postoperative infections. Local~     delivery of antibiotics into the surgical site have been found to significantly decrease~     infection rates in those undergoing posterior spine fusion for traumatic injuries as studied~     in a retrospective manner by the investigators of this grant. In this proposal the~     investigators will prospectively randomize patients undergoing posterior spinal stabilization~     for traumatic injuries into either receiving vancomycin powder into the surgical site~     (treatment) versus not receiving vancomycin powder (control) and subsequently follow~     infection rate, complications, and cost of care. The investigator's hypothesis is that i)~     vancomycin powder will decrease infection rates ii) have no systemic toxicity iii) and be a~     cost saving advancement in the safety of delivering spine surgical care.~   "
152800|NCT01566318|"~     Seniors who receive supportive services face a variety of psychosocial vulnerabilities that~     put them at risk for depression. One group with very high risk is older adults receiving~     aging services through Medicaid waiver programs. This 3-year research uses a randomized~     controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem~     solving therapy [PST] and Brief Behavioral Therapy for Insomnia [BBTI]) to prevent depression~     in seniors receiving aging services.~   "
161210|NCT01455883|"~     Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to~     metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.~   "
152793|NCT01566409|"~     Constipation is a common problem among children. The majority of children suffering from~     constipation have no underlying disease. Although constipation has no basis in underlying~     disease, it often leads to a reduced quality of life of children who are on par with or worse~     than for children suffering from serious diseases such as cardiovascular and rheumatic~     diseases.~      Despite the high frequency of constipation among children, little is known about the causes~     and treatment of constipation.~      Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol~     junior has proven very effective and are therefore widely used in children as disimpaction~     and maintenance treatment. There is currently no research to prove the need for and length of~     maintenance treatment with laxative medications in children.~      The purpose is to examining the effectiveness of maintenance treatment with Movicol.~     Additional til study will examine how the anal diameter change during a course of treatment~     and the degree to which it can be used as an indicator of treatment efficacy.~      The study will test the following:~      • What is the effect of maintenance treatment with PEG compared to placebo?~      The results from this study are expected to form the basis for an evidence-based approach to~     the use of maintenance therapy and the use of ultrasound of the rectum in children with~     constipation.~   "
152794|NCT01566396|"~     The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation~     and resurfacing of the skin, and for the treatment of facial wrinkles. This study was~     designed in order to evaluate the safety and efficacy of the A3F for treatment of facial~     wrinkles.~   "
152795|NCT01566383|"~     The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between~     ages, gender, race and different values of body mass index (BMI). This fact can cause new~     modifications in the normal values such as making new scales for different age groups or BMI~     groups.~      Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never~     experienced reflux related symptoms and are in between the same ranges of age and BMI of our~     gastroesophageal reflux disease (GERD) patient population.~   "
152796|NCT01566370|"~     This is a randomized, double blind, placebo controlled trial of the medication zonisamide for~     the purpose of reducing heavy drinking and drinking, as well as reducing mood symptoms, in~     bipolar subjects that drink excessively and heavily.~      Hypotheses: (Primary aims); Add-on zonisamide compared to placebo will result in:~        1. significant reduction in heavy drinking days, drinks per week and per drinking day, and~          significantly greater increase in abstinent days, ii) greater rates of abstinence and~          abstinence to heavy drinking, greater reduction in biomarkers of heavy alcohol use such~          as gamma-glutamyl transferase (GGT), and greater reduction in alcohol urge or craving,~        2. Significant reduction in prevalent mood symptoms on the BRMS and BRMeS, CARS, HAMD, or~          no worsening of euthymic mood, and significant improvement on the Clinical Global~          Impressions Scale-Severity.~        3. (Secondary aims) Add-on zonisamide compared to placebo will result in significant~          reduction in weight (kilograms) and other secondary weight-related metabolic factors~          such as fasting glucose, lipid profile, and blood pressure.~        4. (Secondary aims) Add-on zonisamide compared to placebo will result in improved clinical~          global impression, overall functioning, quality of life, and reduced medical symptoms.~      5.) (Exploratory Aims) To will examine interactions between genotype and medication on~     treatment response for allelic variation in genetic loci related to the major~     neurotransmitter and neurophysiologic pathways that are relevant to bipolar disorder,~     alcoholism, and zonisamide mechanism of action.~   "
152797|NCT01566357|"~     This in situ study aims to investigate~        -  the protective potential of milk and fluoridated milk on erosive wear of enamel~        -  the protective potential of milk and fluoridated milk on erosive wear of dentin~        -  to compare to protective potential of milk and fluoridated milk with products containing~          casein phosphopeptide-amorphous calcium phosphate~        -  to compare the protective potential of milk and fluoridated milk with a fluoridated~          toothpaste or stannous-chloride containing fluoride solution (SnCl2/AmF/NaF)~   "
152798|NCT01566344|"~     Frequent monomorphic premature ventricular complexes (PVCs) may cause a cardiomyopathy (CMP)~     that is reversible by suppression of the ectopic focus. This study investigates whether PVC~     suppression therapy can improve cardiac function and clinical condition of patients with~     idiopathic or ischemic CMP and frequent monomorphic PVCs. For this purpose, patients will be~     randomized to either one of two treatment strategies: 1) conventional heart failure therapy~     plus PVC suppression therapy, consisting of RFCA as primary treatment and Amiodarone as~     secondary treatment in case of unsuccessful RFCA, or 2) conventional heart failure therapy~     without PVC suppression therapy.~   "
152799|NCT01566331|"~     Safety of natural, vaginal labor for parturient, fetus and newborn is one of most important~     goal among obstetricians, midwifes, scientific society all over the world. Maternal and~     newborn clinical problems and complications following vaginal delivery cause a big amount of~     medico-legal problems and high costs in the sanitary field.~      Among the maneuvers that are used in the second stage of labor, uterine fundal pressure is~     one of the most controversial and often diffuse in all over the world, generally not~     documented, or under reported in medical records . Many Authors affirms that a different new~     way to push may be of help. This maneuver was introduced by Kristeller, that in 1867 minutely~     described a procedure to shorten, through the application of a pressure on the uterine fundus~     whose intensity was quantified by a dynamometer and the duration measured in seconds, the~     length of the second phase of the labor. Although uterine fundal pressure maneuver was~     described by Kristeller as the placement of two hands on the uterine fundus and the~     consequential application of longitudinal steady pressure at a 30- to 45-degree angle~     directed toward the pelvis, with the avoidance of direct pressure toward the maternal spine,~     there is no clear definition of the maneuver and no indication for its use has been formally~     described to date.~      The aim of this study was therefore to assess whether the use of the Baby-guardTM system,~     through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of~     biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure~     during the second stage of labor in the direction of the pelvic outlet, may be of maternal~     and fetus aid for a safe natural childbirth for their better outcomes.~   "
152877|NCT01565317|"~     The purpose of this study is to find out the impact of improving diabetes control through~     weight reduction and lifestyle changes on a common diabetes complication called peripheral~     neuropathy.~   "
152801|NCT01566305|"~     Rationale and objective:~      Based on the results of a pilot study, the objective of the present study is to evaluate~     whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL~     cholesterol raising effects of eggs.~      Study Design:~      The study has a randomized placebo-controlled factorial 2x2 design. The total study duration~     is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period.~     Subjects will be stratified for age, gender and BMI over the experimental groups.~      Study population:~      One hundred and eight healthy male and female subjects, aged 18-70 years, with slightly~     elevated serum total cholesterol concentrations (5.5-8.0 mmol/l).~      Intervention:~      During the entire study period, volunteers are instructed to consume a diet according to the~     Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates). During~     the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed milk.~     During the 12 weeks experimental period, a first group of subjects will continue drinking the~     skimmed milk (control group), while a second group will consume a low-fat buttermilk, a third~     group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk incorporated into a~     low-fat buttermilk based beverage. The egg-yolk will be enriched in lutein. Whole egg~     consumption (others than provided by us) is not allowed during the entire study.~      Main study parameters/endpoints:~      Measurements will be performed during the run-in period (days 0, 11 and 14) and during the~     experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk~     consumption) will be calculated as the absolute differences between values obtained at the~     end of the experimental (average days 95 and 98) and run-in (average days 11 and 14) periods.~     The primary endpoint is the change in serum LDL cholesterol concentrations. Secondary~     endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and~     hsCRP concentrations.~   "
152802|NCT01566292|"~     The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal~     invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign~     prostatic hyperplasia (BPH).~      Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and~     unsatisfactory response to combined medical therapy.~   "
152803|NCT01566279|"~     The investigators hypothesize that certain mutations in the individual cancer genomes will~     predict response to Everolimus therapy. To identify possible genetic mutations that affect~     tumor response to Everolimus the investigators will obtain sequence analysis of tumors from~     all patients that will be treated with Everolimus in this study. Moreover, the investigators~     performed a systematic review of the currently available data to identify mutations that~     could be predictive for increased mTOR activity in cancer cells. These mutations have been~     described to lead to mTOR activation but their predictive value for response to Everolimus~     therapy remains unclear. The investigators will use the data generated in the investigators~     own prospective treatment study and the data from literature to select patients for entry~     into a second part of this trial. In this part the investigators want to test the hypothesis~     that selecting patients based on their specific genetic mutations increases the likelihood of~     response.~   "
152804|NCT01566266|"~     It is well known that metabolic responses to diet and drugs are affected by genetic and~     environmental factors. Still, a large part of differences in responses between individuals~     remains unexplained. To increase our understanding of individual differences, more and more~     attention is paid to the role of intestinal microbiota. Not only energy and glucose may be~     related to the microbiota, but also lipid metabolism. This is not surprising as lipid~     metabolism, glucose metabolism, and obesity are closely linked.~      There is substantial evidence from in particular animal studies that the gut microbiota is~     related to lipid and lipoprotein metabolism. However, there is less evidence to what extent~     modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.~   "
152805|NCT01566253|"~     C-section deliveries are painful and need adequate analgesia. In the same time, mothers need~     early rehabilitation to take care of the baby.~      Hypothesis: Early oral self administration of painkillers could be as effective as usual IV~     administration by nursing staff.~      Purpose of the study: Evaluation of the efficacy of a program of self administration of~     painkillers postoperatively of C-section delivery.~   "
152806|NCT01566240|"~     Chemoradiation has been the standard treatment for advanced cervical cancer for a decade, but~     one third of women still die from a failure to control systemic disease. In a recent~     multicentre phase II trial of 46 women the investigators found that, 68% of women had tumours~     that responded to weekly induction chemotherapy prior to chemoradiation. The induction~     chemotherapy had acceptable toxicity and did not compromise the standard chemoradiation~     treatment. In addition, the overall survival and progression free survival at 3 years was 66%~     (95% CI 4779). These results, together with acceptable toxicity, provide justification for~     evaluating induction chemotherapy prior to chemoradiation in a randomised phase III trial.~     The investigators aim to investigate in a randomised trial whether additional induction~     chemotherapy given on a weekly schedule immediately before standard chemoradiation leads to~     an improvement in overall survival. The investigators plan to recruit 770 women with locally~     advanced cervical cancer who are eligible for standard chemoradiation, they will be~     randomised to weekly carboplatin and paclitaxel chemotherapy for 6 weeks followed by~     chemoradiation or to chemoradiation alone. The trial will recruit for 4 years with 5 years of~     follow up period.~   "
152807|NCT01566227|"~     This research is being done to find out the ideal number of implants/attachments required to~     provide adequate stability of dentures during function.~   "
152808|NCT01566214|"~     The purpose of this research study is to survey patients to learn about their beliefs and~     behaviors related to the management of heart disease and to discuss options for making~     healthy lifestyle changes. From the information the investigators get from patients, the~     investigators hope to develop better methods for taking care of patients who have heart~     disease.~   "
152809|NCT01566201|"~     Inhibition of interleukin-1 (IL-1) activity in patients with RA without CAD ameliorates~     vascular and LV function. Moreover, data from species shows beneficial effect of this~     treatment on LV function after experimental myocardial infarction. The purpose of this study~     is to investigate whether anakinra, an IL-1 receptor antagonist, improves vascular and left~     ventricular (LV) function in patients with coronary artery disease (CAD) and coexistent~     rheumatoid arthritis (RA).~   "
152810|NCT01566188|"~     The overall aims of the present project are to investigate the impact of a nutritional~     approach based on omega-3 from vegetal origin on vascular function in hypertension associated~     with metabolic syndrome.~   "
152811|NCT01566175|"~     The purpose of this study is to implant the Reducer in patients with the symptoms of~     refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.~   "
152812|NCT01566162|"~     This is a 12-week, multi-center, open-label extension study designed to evaluate the~     longer-term safety, tolerability and effectiveness of lurasidone for the treatment of~     subjects with schizophrenia.~   "
152813|NCT01566149|"~     The purpose of this study is to assess the safety, tolerability & effectiveness of 2~     strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the~     treatment of persistent asthma in adults & adolescents.~   "
152814|NCT01566136|"~     Hip fractures are a danger to an individual's mobility, independence and ability to live in~     the community. When patients have a cognitive impairment (such as dementia or delirium) they~     do not recover as well or go back to their homes as often as those patients who do not have a~     cognitive impairment. Therefore, our team developed a rehabilitation model to care for~     patients with hip fractures, and specifically for those patients with CI. The model of care~     is called the Patient Centred Rehabilitation Model of Care (PCRM-CI). This 3 year study will~     focus on comparing the new model with usual rehabilitation care. This study will also focus~     on understanding the factors that could influence the use of the model on new rehabilitation~     units. The investigators hypothesize that patients who have received the new model of care~     will have better mobility outcomes over time. The investigators will collect data in 2~     hospitals, 70 patients receiving the usual care and 70 patients receiving the care in the new~     model. The team will invite 60 staff and their unit managers as well. This study will help~     decision makers to use research findings to make better decisions about care of older~     Canadians.~   "
152815|NCT01566123|"~     Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain~     disappointing even after gross total resection, mainly because wide margins are not~     achievable in the majority of patients. In contrast to extremity sarcoma, postoperative~     radiation therapy (RT) has shown limited efficacy due to its limitations in achievable dose~     and coverage. Although Intraoperative Radiation Therapy (IORT) has been introduced in some~     centers to overcome these dose limitations and resulted in improved outcome, local failure~     rates are still high even if considerable treatment related toxicity is accepted. As~     postoperative administration of RT has some general disadvantages, neoadjuvant approaches~     could offer benefits in terms of dose escalation, target coverage and reduction of toxicity,~     especially if highly conformal techniques like intensity-modulated radiation therapy (IMRT)~     are considered.~      Therefore the RETROWTS trials has been designed as a prospective, one armed, single center~     phase I/II study investigating a combination of neoadjuvant dose-escalated IMRT (50-56 Gy)~     followed by surgery and IORT (10-12 Gy) in patients with at least marginally resectable RSTS.~     The primary objective is the local control rate after five years. Secondary endpoints are~     progression-free and overall survival, acute and late toxicity, surgical resectability and~     patterns of failure. The aim of accrual is 37 patients in the per-protocol population.~   "
152816|NCT01566110|"~     Currently no consensus exists on the optimal way to manage asymptomatic patients with celiac~     disease (CD) and Type 1 diabetes (T1D). The impact of dietary treatment as it pertains to~     clinically relevant outcomes such as metabolic control, bone mineralization and wellbeing~     will be evaluated in this study. A randomized controlled study longitudinally evaluating~     HbA1c and glycemic excursions using continuous glucose monitoring will rigorously determine~     the impact of a gluten-free diet (GFD) on blood glucose variability in patients with T1D.~   "
152817|NCT01566097|"~     Despite the establishment of various smoking cessation methods, including pharmacological~     intervention, only a small proportion of smokers who visit doctors choose to receive such~     assistance. Such under-utilization is especially apparent in some cultures, as in the case of~     Korea, where a government survey showed that only 0.5% of current or formal smoker reported~     they had been prescribed smoking cessation medication. Shame in asking for help for an~     addictive disorder has been recognized as one of the most recognized cultural barrier in~     Asian-American population. It is clear that culturally focused studies on smoking cessation~     is warranted.~      Patient decision aids are tools that help people become involved in decision making by~     providing information about the options and outcomes and by clarifying personal values.~     Patient decision aids have been developed to help patients decide whether to quit smoking or~     not, or whether to use smoking medication or not. However, such previous studies have only~     been focused on western populations.~      The main purpose of this study is to develop a culturally appropriate decision aid for~     smoking cessation for the Korean population, as well as evaluate its effect on their decision~     to use smoking cessation medication. The investigators expect that culturally tailored~     smoking cessation decision aids would increase knowledge about efficacy of smoking cessation,~     make people have more positive attitudes toward smoking cessation medication, encourage~     people to discuss about smoking cessation medication with their physicians. Ultimately the~     investigators expect it would increase usage of smoking cessation medication and enhance the~     quitting rate of smoking, which is a very important clinical issue.~   "
152818|NCT01566084|"~     The investigators hypothesize that reducing salt in the diet will improve the function of~     blood vessels in middle aged and older adults with moderately elevated systolic blood~     pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and reducing~     the amount of oxidative stress.~   "
152819|NCT01566071|"~     The main objectives of this study are:~        -  To evaluate the driving capacities in a population of elderly subjects with early stage~          Alzheimer Disease (AD) in a real-life situation.~        -  Define a typology of the main errors made in this population.~        -  Propose adaptive measures or technological aids that would make it possible for these~          patients to maintain their ability to drive a car while limiting risk.~   "
152820|NCT01566058|"~     The main objective of this study is to compare the degree of maternal anxiety at Day 3~     postpartum in mothers who did or did not have access to a video communication system (BB-Box~     system) from the time of initial separation with their baby.~   "
152821|NCT01566045|"~     This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion~     biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing~     subjects with prostate cancer.~   "
152822|NCT01566032|"~     The amount of air leaking from a chest tube can be measured in two main ways:~        1. electronic monitor connected to the chest tube~        2. numerical (non-electronic) monitor connected to the chest tube~      For people who have had lung surgery, it is important to understand the impact of measuring~     air leaks accurately in both the short term and the long term. An electronic medical device~     called Thopaz measures air leak electronically. Another medical device called Pleur-evac~     measures air leak numerically. The purpose of this study is to understand the accuracy of the~     method used by doctors and nurses to determine if a chest tube has an air leak. It is also~     important to determine the size or severity of an air leak.~   "
152878|NCT01565304|"~     The purpose of this study is to evaluate the effectiveness of the POWER Through Choices (PTC)~     curriculum in increasing contraceptive use and delaying sexual initiation among youth living~     in group foster care homes.~   "
152824|NCT01566006|"~     Diabetes mellitus (DM) is a growing disease and it is a public health concern, and~     projections of its future effect are alarming. About one third of those affected will develop~     diabetic nephropathy at 20 years after diagnosis. Of these patients, 20% will develop~     clinically end-stage renal disease ESRD, requiring renal replacement therapy (RRT). Patients~     with type 2 diabetes account for most patients with end stage renal disease (ESRD) and RRT.~      To the best of the investigators knowledge, the effects of MMF on diabetic nephropathy in~     patients with DM type II were not studied so far. Therefore, the purpose of this pilot study~     is to evaluate the effects of Mofetil Mycophenolate (MMF) on proteinuria and progression of~     kidney disease of diabetic origin, in patients at high risk for progressive renal failure in~     whom other treatment modalities are insufficient or had failed.~   "
152825|NCT01565993|"~     The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before~     polypectomy in our usual clinical practice, through a prospective randomized study that~     determines their effectiveness compared to conventional polypectomy, assessing the decrease~     in immediate and delayed post-polypectomy bleeding~   "
152826|NCT01565980|"~     Managing psychological and physical symptoms to improve quality of life in patients with lung~     cancer are a major public health concern. Mindfulness-based therapies are showing promise in~     modifying psychological distress and improving quality of life in some cancer groups, but~     little testing has included lung cancer samples. Mindfulness-based therapies integrate~     meditation, breathing, and gentle yoga practices to promote an attitude of nonjudgmental~     acceptance and awareness of bodily states. Such strategies may promote well being,~     self-regulation, and symptom management. The study purpose was to test the acceptability,~     feasibility, and symptom / health-related quality of life (HRQOL) outcomes of a home-based~     mindfulness intervention for individuals with advanced lung cancer during non-curative~     treatment (radiation and/or chemotherapy). Acceptability and feasibility were measured via~     patient consent and retention rates, therapy expectancy, study adherence, attrition reasons,~     and quality assurance indicators. Efficacy was determined via symptom and HRQOL (health~     perceptions, physical and emotional function) outcomes. 40 patients undergoing treatment of~     non-small cell lung cancer were randomized to receive either six weekly mindfulness sessions~     (N=20) or an attention control condition (N=20). Outcome data was obtained at baseline (Time~     1), post-intervention (Time 2, week 8), and four weeks after completion (Time 3, week 11). In~     addition, both groups received weekly symptom assessment interviews. The hypothesis was that~     the mindfulness group would report better symptom management and HRQOL (lower worry, dyspnea,~     insomnia, depression; higher physical and social function; more positive health perceptions)~     than the attention control group at the protocol end and that these differences will be~     sustained at Time 3.~   "
152827|NCT01565967|"~     The purpose of this study is to show the success of the AutoLog System in removing lipids to~     less than 10mg/dl in vivo. The Autolog registry has two objectives:~        1. to determine the lipid removal capabilities of the Medtronic AutoLog System.~        2. to obtain in vivo data on blood component removal and washing capabilities of the~          Medtronic AutoLog System.~   "
152828|NCT01565954|"~     In Sickle cell disease children, sleep respiratory abnormalities are risk factors for~     vaso-occlusive complications, as well as cerebral vasculopathy.~      A 18 months follow-up children with sickle cell disease evaluating sleep respiratory problems~     frequency and etiology, as well as their influence on sickle cell disease complications.~   "
152829|NCT01565941|"~     Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels,~     is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown~     to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult~     critically ill surgical patients but has since come under intense scrutiny due to conflicting~     results in recent adult trials. One pediatric RCT has been published to date that~     demonstrated survival benefit but was complicated by an unacceptably high rate of severe~     hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT) trial is a~     multi-center, randomized clinical treatment trial comparing two ranges of glucose control in~     hyperglycemic critically ill children with heart and/or lung failure. Both target ranges of~     glucose control fall within the range of usual care for critically ill children managed in~     pediatric intensive care units.~      The purpose of the study is to determine the comparative effectiveness of tight glycemic~     control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of~     150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU)~     length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or~     respiratory failure. This will be accomplished using an explicit insulin titration algorithm~     and continuous glucose monitoring to safely achieve these glucose targets. Both groups will~     receive identical standardized intravenous glucose at an age-appropriate rate in order to~     provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an~     explicit algorithm combined with continuous glucose monitoring using a protocol that has been~     safely implemented in 490 critically ill infants and children.~   "
152830|NCT01565928|"~     The purpose of this study is to determine the safety of MDV3100 given in combination with~     Docetaxel in men with advanced prostate cancer.~   "
152831|NCT01565915|"~     The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.~   "
152832|NCT01565902|"~     This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate~     and severe hepatic impairment compared to healthy control subjects.~   "
152833|NCT01565889|"~     This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early~     viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the~     safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its~     metabolites in participants with HIV and hepatitis C virus (HCV) coinfection. Part B, the~     Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated~     interferon alpha (PEG) and ribavirin (RBV) in participants with HIV/HCV coinfection.~   "
152834|NCT01565876|"~     Combat soldiers are required to perform under strenuous physical conditions; hence, their~     physical fitness is a crucial factor in their survivability.~      The Auxiliary Device- Minkal, is suggested (by its manufactures) to be able to reduce the~     soldiers' physiological strain by lowering the absolute load being carried by the soldier. As~     a result, it may improve the soldier's physiological abilities and performance through~     enduring missions with heavy loads, and may lead to better protection on the soldier from~     overuse injuries.~   "
152837|NCT01565837|"~     The purpose of this study is to evaluate if precisely-targeted radiation therapy, known as~     stereotactic ablative radiotherapy (SART), given during treatment with the drug ipilimumab~     (Yervoy) will improve survival for patients with melanoma that has spread to five or fewer~     sites (oligometastatic).~      Blood samples will be collected for research purposes. Planned studies include exploration of~     certain gene mutations and serum markers as predictors of response to ipilimumab treatment.~     Research lab studies will also evaluate if circulating tumor cells (CTC) can be accurately~     detected and isolated from the blood using novel laboratory techniques and if they are a~     prognostic/predictive marker for treatment response. Test results will not be given to~     participants or their physicians. In some cases, CTC may be grown for long-term cell lines~     for further research.~   "
152838|NCT01565824|"~     The aim is to investigate whether the implementation of a web-based support to women with~     type 1 diabetes during pregnancy and early motherhood can improve well-being and self~     management of diabetes. Type 1 diabetes is associated with increased medical risks and~     increased psychosocial pressure in relation to childbearing. There is need for extended~     support from both health care professionals and peers. Web-based interventions can improve~     personal capacity and self-management in people with long- term illnesses but are not~     evaluated in childbearing women with type 1 diabetes. A web site prototype for full-size~     browsers and mobile devices has been developed through a participatory design by~     multidisciplinary researchers, health care professionals, experienced mothers with type 1~     diabetes and web designers. In a randomised control study the developed web site offering~     information, communication with health care professionals, person-centred self-care diaries~     and online social community of included women, is provided to the intervention group in early~     pregnancy at admission to specialised antenatal clinics at six hospitals in Sweden. A control~     group will receive standard care (usual care). Total n = 160. Primary outcomes are Well-Being~     Questionnaire and Diabetes Empowerment Scale. The intervention offers proactive solutions for~     strengthening patients' decision making of diabetes in daily life during pregnancy and early~     motherhood, and is expected to increase their wellbeing, personal capacity and knowledge of~     diabetes.~   "
152839|NCT01565811|"~     Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal~     cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic~     factors in oncologic surgery; however, the role of lymph node dissection remains unclear for~     colorectal cancer liver metastasis.~   "
152840|NCT01565798|"~     CONTEXT: Healthcare-acquired infections (HAI) cause substantial patient morbidity and~     mortality. Commonly touched items in the patient care environment harbor microorganisms that~     may contribute to HAI risk. Thus, reduction in the surface bioburden may be an effective~     strategy to reduce HAI. Inherent biocidal capabilities of copper surfaces offer a theoretical~     advantage to conventional cleaning, as disinfection is continuous rather than episodic.~      OBJECTIVE: Determine whether placement of copper-alloy surfaced objects in an intensive care~     unit (ICU) reduce risk of HAI.~      DESIGN: An intention to treat study where patients are sequentially placed into rooms with or~     without copper-alloy surfaced objects.~      SETTING: The ICUs of three hospitals, a tertiary academic hospital, an academic cancer~     center, and a Veteran's Administration Medical Center.~      PATIENTS: Any patient 18 years of age or older who required admission to an ICU at a study~     hospital is eligible for placement into a study room if available.~      INTERVENTION: Placement of copper-alloy surfaced objects in an ICU room. MAIN OUTCOME~     MEASURE: Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus~     aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.~   "
152841|NCT01565785|"~     The purpose of this study is to pilot test the 'Family Self- Management Discharge Preparation~     Intervention [FSM-DPI]' that focuses on content and delivery methods to support an effective~     family transition to home self-management after a child's hospitalization.~   "
152842|NCT01565772|"~     This research study is looking at an alternative way of delivering radiation therapy with~     protons. Protons are tiny particles with a positive charge that can be controlled to travel a~     certain distance and stop inside the body. In theory, this allows better control of where the~     radiation dose is delivered as compared to photons. Information from other research studies~     suggests that proton radiation may help to reduce unwanted side effects from radiation and~     allow an increase in radiation dose that increase the odds of tumor killing.~      The purpose of this study is to determine the safest dose of proton radiation therapy to give~     in combination with standard chemotherapy in participants with Non-Small Cell Lung Cancer~     (NSCLC).~   "
152843|NCT01565759|"~     Psychiatric disorders often result from dysregulation in cellular and molecular mechanisms at~     the level of the brain. Unable to directly study brain tissues in patients affected by~     psychiatric conditions, researchers have created alternative experimental models that use~     different and easy to collect tissues. The underlying assumption is that by studying these~     proxy tissues, it is possible to obtain information on biological mechanisms that is a good~     approximation of what would be detected in the brain. One of the most established~     experimental models are lymphoblastoid cell lines derived from B-lymphocytes. Lymphocytes are~     present in the peripheral blood and can be easily collected and stored virtually forever~     after undergoing a special laboratory procedure that immortalize them. These cell lines have~     proved to be very useful in genetic and pharmacogenetic research and, using these, the~     investigators want to investigate the cellular effects of a mood stabilizing drug called~     lithium on this specific procedure that makes them virtually immortal. Two main reasons lead~     us to study this drug: 1) it is the most effective treatment in bipolar disorder, where~     approximately 30% of patients achieve complete illness remission with prevention of episode~     recurrence; 2) it has well established regulatory effects on the expression of specific~     target genes and proteins. The investigators can take advantage of these well-established~     properties of lithium in regulating the expression of genes, proteins, and enzymes in a~     stable manner. Conversely, these biological measures could be used as markers for the effects~     of lithium on the gene expression.~      The purpose of this study is to learn more about the changes in the activity of genes in~     cells sampled from healthy individuals treated with lithium. By studying these cellular~     changes, the investigators hope to understand if lymphoblastoid cell lines are valid tools in~     psychiatric genetics research. Specifically, the investigators want to see how specially~     treated lymphoblastoid cell lines are influenced by external conditions and specifically~     lithium treatment at the moment of sampling. To do so, the investigators will measure the~     gene expression (i.e. how much gene is in the cell) of lymphoblastoid cell lines and compare~     the levels between those sampled before and after one month of lithium treatment.~   "
152844|NCT01565746|"~     This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety,~     biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in~     Japanese patients with castration-resistant prostate cancer and bone metastases.~   "
152845|NCT01565733|"~     This study is conducted in Europe. The aim of this study is to evaluate the safety and~     efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2~     diabetes with the aim of intensifying their treatment.~   "
161211|NCT01455870|"~     Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin~     monotherapy in patients with type 2 diabetes.~   "
152846|NCT01565720|"~     This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in~     healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups~     and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an~     active control on the last dosing day to healthy subjects in one of the four groups. All~     treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the~     study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on~     three study days. ECGs, vital signs, blood draws will be obtained throughout the study for~     safety and to assess the amount of study drug in body.~   "
152847|NCT01565707|"~     Solifenacin succinate as a tablet formulation is already on the market for the treatment of~     symptoms of overactive bladder in adults. For the use in children and adolescent patients a~     new formulation of solifenacin has been developed.~      This study investigated the effect and safety of solifenacin succinate liquid suspension~     compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the~     double blind period was a single-blind placebo run-in period in combination with behavioral~     urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder~     (OAB) information, awareness, instruction, life-style advice and documentation of voiding~     habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also~     investigated how well solifenacin succinate suspension is taken-up by the body and how long~     it stays in the body during this time.~   "
152848|NCT01565694|"~     The purpose of this study was to investigate a medicine for the treatment of symptoms and~     complications of neurogenic detrusor overactivity (NDO) in children and adolescents.~   "
152849|NCT01565681|"~     The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and~     pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in~     healthy subjects.~   "
152850|NCT01565668|"~     This study will evaluate two doses of Quizartinib in patients with relapsed or refractory~     acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication (~     FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment~     arms. Both treatment arms will receive Quizartinib but at different doses. The study~     treatment is taken orally in 28 day cycles until either disease progression occurs or an~     unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease,~     blood will be drawn to measure drug levels and biomarkers. Patients will be followed for~     survival at three month intervals after the end of treatment.~   "
152851|NCT01565655|"~     The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to~     severe rheumatoid arthritis (RA) subjects~   "
152852|NCT01565642|"~     This cluster randomized controlled trial is to examine whether decision support for goals of~     care can improve quality of communication and decision-making and improve the quality of~     palliative care for nursing home residents with advanced dementia.~   "
152853|NCT01565629|"~     This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT)~     program for children with anxiety and autism spectrum disorders.~   "
152854|NCT01565616|"~     This is a Phase II, single arm, multi-center trial. It is designed to estimate the efficacy~     and toxicity of hematopoietic stem cell transplantation (HSCT) in patients with sickle cell~     disease (SCD) who have high risk features.~      The primary goal of this multi-center Phase II study is to determine the safety and~     feasibility of a conditioning regimen consisting of busulfan (Bu)/ fludarabine (Flu)/~     anti-thymocyte globulin (ATG) in adult patients with severe SCD. A two-component design will~     be used for this study. The first component will be restricted to patients who have an~     HLA-identical sibling donor. Five patients will be transplanted during the first component of~     the study. If no more than 2 of the first 5 patients experience unacceptable toxicity,~     including death, within the first six months after transplantation, then the safety of the~     regimen will be considered promising in adult SCD patients.~      The second component will include patients who have a related or an unrelated human leukocyte~     antigen (HLA) matched donor. Up to 15 additional patients will be transplanted in this~     component of the study which will evaluate the safety and feasibility of unrelated donor~     hematopoietic cell transplantation (HCT) in adults with SCD. Data related to study endpoints~     for 1 year after transplantation will be collected; however, participating centers will be~     encouraged to conduct long-term follow-up evaluations of patients according to standard~     institutional guidelines. The purpose of this pilot safety trial is to see if this approach~     is feasible and meets accrual goals lending support to the development of a subsequent full~     scale investigation of HCT and comparing outcomes in a transplantation cohort to a control~     cohort of adults eligible for, but unwilling or unable to receive HCT treated by supportive~     therapy with a primary endpoint of five years survival for this full scale comparative trial.~   "
152855|NCT01565603|"~     Mechanisms underlying high-altitude intolerance as well as exercise performance limitation in~     hypoxia still remain to be fully understood. Recent data suggest that sleep disturbances on~     one hand and cerebral perturbations on teh other hand may be key mechanisms. The~     investigators evaluated 12 healthy subjects at sea level and at 4400 m of altitude for 7 days~     in order to better describe sleep and cerebral responses. The investigators hypothesized that~     sleep and cerebral disturbances play a critical role for the developement of acute mountain~     sickness and for exercise performance limitation during acute high-altitude exposure.~   "
152856|NCT01565590|"~     The purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage~     on dexmedetomidine compared to propofol to assess if one group has decreased inflammation.~     The investigators hypothesis is that the group assigned to receive dexmedetomidine will have~     a more profound decrease in markers of inflammation over time.~   "
152857|NCT01565577|"~     This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in~     children aged 4-8 years.~   "
152858|NCT01565564|"~     Research question (s)/hypothesis:~        1. . The effectiveness of the shared care management of gestational diabetes mellitus;~        2. . The cost-effectiveness of the shared care management;~        3. . Its sustainability~   "
152859|NCT01565551|"~     The global aim of this proposal is to test and refine Common Data Elements (CDEs),~     neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain~     Injury (TBI) studies. Testing and validating of TBI-CDEs will be performed in a multi-center~     prospective observational study with 3 TBI Centers (San Francisco General Hospital (SFGH),~     University of Pittsburgh Medical Center (UPMC), University Medical Center Brackenridge~     (UMCB)) and a TBI Rehabilitation Center (Mount Sinai Rehabilitation Center (MSMC)). The~     investigators will create and expand existing data repositories for patient demographics,~     neuroimaging, plasma biomarkers, genetics, and multivariate outcomes thereby providing~     researchers and clinicians with the infrastructure to establish multidisciplinary,~     multicenter research networks and improve clinical research in the TBI field.~   "
152879|NCT01565291|"~     A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of~     healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron~     emission tomography (PET) scanner.~   "
152860|NCT01565538|"~     Both pemetrexed and erlotinib are second-line treatment options for patients with advanced~     non-small cell lung cancer. It is controversial that whether it is necessary to detect~     epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after~     the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive~     marker remains controversial. Therefore, we investigate the efficacy of erlotinib and~     pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR~     FISH-positive advanced lung adenocarcinoma.~   "
152861|NCT01565525|"~     The purpose of this pilot project is to test anticipatory guidance, which is information~     given to families during a well child visit to prevent obesity during childhood. The~     objectives were to compare two styles of anticipatory guidance during the first year of life,~     maternal focused and infant focused, versus usual care and determine which style, if any,~     showed the most ideal infant feeding behaviors at age 1 year and to see if there were any~     differences in infant weight for height at one year of age. The investigators hypothesized~     that mothers who received the maternal focused anticipatory guidance (which gave information~     on eating family meals, not having tv on during meals, and maternal nutrition) would actually~     have the best infant feeding behaviors and weight for height of infants at one year.~   "
152862|NCT01565512|"~     The indwelling urethral foley is a major source of discomfort following radical~     prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with~     bupivacaine may decrease immediate post-operative foley discomfort.~   "
152863|NCT01565499|"~     Study GEICAM 2011-02 is a multicenter, open label, non-randomized phase 2 trial to evaluate~     the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive HER2~     negative patients amenable to receive neoadjuvant chemotherapy.~      The primary objetive of the trial is to determine the percentage of patients with poor~     response [residual cancer burden III (RCB-III) rate] in contrast to good response [residual~     cancer burden 0/I RCB-0/1] measured by the Symmans criteria [20] at surgery, in patients with~     stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.~      The primary endpoint of the study is to determine the residual cancer burden grade III~     (RCB-III) after surgery.~      The total number of patients to be included in this study is 78 patients.~      The duration of the study, from first patient visit to last patient visit will be~     approximately 90 months (Including follow-ups)~   "
152864|NCT01565486|"~     The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device~     (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure~     Precise™, Covidien) in surgery for thyroid cancer.~      Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES),~     Recurrence-free survival (RFS), Overall survival (OS)~   "
152865|NCT01565473|"~     This research plan is focused on neurochemical positron emission tomography (PET) studies of~     Parkinson disease (PD). PD is the most common neurodegenerative movement disorder, and~     considerable progress has been made in understanding and treating the typical movement~     abnormalities of resting tremor, bradykinesia and rigidity. These cardinal PD features are~     all initially responsive to dopamine replacement therapy, and have been investigated~     intensively with respect to their relationships to degeneration of the nigrostriatal dopamine~     projection. More recently, increased attention has focused on the non-motor clinical~     aspects of PD, including cognitive, mood, chronobiological and peripheral autonomic defects.~     These clinical features are less reliably affected by dopaminergic therapy, and are likely to~     be associated with other, non-dopaminergic neural degenerations. Indeed, detailed postmortem~     assessments of PD brain reveal substantial neuronal losses in a variety of chemically-defined~     neurons, including brainstem serotonin and norepinephrine neurons and basal forebrain~     cholinergic neurons. Projects in the proposal will focus on dementia, depression, sleep-apnea~     and dysautonomia in PD patients, employing PET measures of presynaptic dopaminergic,~     serotoninergic and cholinergic CNS neurons and of peripheral sympathetic neurons. Results of~     the investigations may identify associations of non-motor PD signs and symptoms with the~     non-dopaminergic neuronal losses. These findings will establish additional therapeutic~     targets for symptomatic, but also for potential neuroprotective PD therapies. In addition, a~     majority of patients will be characterized with all 3 CNS PET measures. The availability of~     multiple markers of distinct neuronal populations involved in PD neurodegeneration will~     permit exploratory analyses to assess whether the degenerations are correlated (possibly~     manifestations of a common pathophysiology) or apparently independent (possibly a~     manifestation of multiple PD subtypes or pathophysiologies). Ultimately, better understanding~     of these non-motor features will be essential to developing future treatments that address~     the entire PD patient.~   "
152866|NCT01565460|"~     The purpose of this study is to create a long-term storage of bile and brushings of~     pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future~     research.~      Recently, a lot of research has been done to test for certain markers in the bile and~     brushings to detect cancer in a stricture. The samples will be used to measure biomarkers~     (proteins) in biliary diseases.~   "
152867|NCT01565447|"~     This purpose of this study it to characterize the walking patterns of children diagnosed with~     Acute Lymphoblastic Leukemia (ALL)and Lymphoblastic Lymphoma (LL) at different times in the~     treatment protocol and after completion of treatment. Their walking patterns will be compared~     to children without ALL or LL to see if their walking patterns are different at specific~     times in their treatment program or up to 10 years after completion of their treatment. The~     investigators will gather data by observing how the child walks, runs, hops on one foot and~     climbs stairs and by recording walking patterns on a pressure sensitive mat. The~     investigators will compare this data to children without ALL and LL.~   "
152868|NCT01565434|"~     Main objective: investigate whether a functional polymorphism of CR1 (length, number of~     binding sites in C4b C3b, erythrocyte density, rate of soluble CR1 ...) so determined genetic~     or acquired, is a susceptibility factor for the disease Alzheimer's.~   "
152869|NCT01565421|"~     This study will assess the effect of IT-101 on delaying cancer progression in patients with~     platinum sensitive ovarian cancer.~   "
152870|NCT01565408|"~     This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the~     safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid~     arthritis (RA).~   "
152871|NCT01565395|"~     The purpose of this study is to evaluate the safety and efficacy of Incobotulinum Toxin A~     (Xeomin®) injections into the parotid and submandibular glands in patients with Parkinson's~     Disease/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) with troublesome sialorrhea.~   "
152872|NCT01565382|"~     Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained~     using updated reading methodology. The scans in this study came from subjects who had~     Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).~   "
152873|NCT01565369|"~     The purpose of this study is re-read of brain amyloid positron emission tomography (PET)~     scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated~     reading methodology. The scans in this study came from subjects who had an autopsy to reveal~     the subject's true amyloid status.~   "
152880|NCT01565278|"~     Patients who are not able to eat normally for a longer time require parenteral nutrition,~     i.e. they receive liquids and nutrients directly into their veins. This can have many~     long-term side effects, including liver problems. This study will examine whether a specific~     lipid emulsion containing fish oil can improve liver disease in patients on parenteral~     nutrition. The investigators will compare changes in bilirubin and liver enzymes after 3~     months in 10 patients receiving standard lipid emulsion to 10 patients receiving standard~     lipids + a fish-oil containing emulsion. The investigators will also assess liver histology,~     the kind of fat, oxidative stress and gene expression in the liver at the beginning and after~     6 months of fish-oil. The investigators also want to compare the baseline values from all 20~     patients to 20 healthy controls. This will help to explain how fish oil may improve liver~     disease in patients on parenteral nutrition.~   "
152881|NCT01565265|"~     The purpose of this study is to assess the non-inferiority of a multidose GnRH antagonist~     (cetrorelix) regimen to a GnRH agonist (triptorelin) long protocol in young infertile women~     undergoing ovarian stimulation with Pergoveris 150 I.U./75 I.U. (r-hFSH/ r-hLH) for ICSI~     treatment because of male infertility.~      To assess the efficacy of ovarian stimulation using either a GnRH antagonist (cetrorelix) or~     a GnRH agonist (triptorelin) long protocol in infertile women with good prognosis and to~     determine the safety of ovarian stimulation.~      Subsample analysis: in 10 patients of each of both arms, serum samples will be collected~     daily during the stimulation period and be stored frozen at -70 °C. The following hormone~     concentrations will be measured later in single assay batches: LH, FSH, oestradiol,~     progesterone, androstenedione, testosterone, inhibin A, inhibin B, AMH.~      Multinational, multicentre, open label, randomized, 2-arm parallel-group phase IV study.~     Eligible patients will be randomly allocated to one of the two groups: the agonist group will~     receive Decapeptyl® 0.1 mg (triptorelin) starting in the mid-luteal phase of the natural~     cycle until downregulation until the day of ovulation induction. The antagonist group will~     receive cetrorelix 0.25 mg from stimulation day 6 to ovulation induction. In both groups,~     Pergoveris® 150 I.U./75 I.U. (r-hFSH/r-hLH) will be used for ovarian stimulation from cycle~     day 2 to ovulation induction.~   "
152882|NCT01565252|"~     Study Rationale:~      As epidemiological research has shown negative effects of high egg consumption on increased~     all-cause mortality and diabetes and on diabetes outcomes, and egg modification may modulate~     their effects on diseases risks, it is important to test the effect of eggs with different~     composition on markers associated with dyslipidemia, dysglycemia and inflammation.~      The aim of this study is to assess the effect of n-3PUFA (Omega 3) fortified egg compared to~     omega-6 Israeli regular egg on metabolic, inflammation and other physiologic parameters.~   "
152883|NCT01565239|"~     Experiments suggest that during treatment with vitamin K antagonists (VKA) the activity of~     coagulation factors (F) II and X better reflect anticoagulation than does FVII. Based on this~     a new prothrombin time based monitoring test (Fiix-PT) has been invented which is only~     sensitive to FII and FX. The Fiix-PT can be converted to INR (Fiix-INR).~      The investigators hypothesize that the Fiix-PT may reflect anticoagulation and the~     antithrombotic effect of VKA as accurately or better than the current PT based tests do (INR~     based on PT or P&P). The protocol describes a prospective randomized double-blind trial that~     will be conducted at the Landspitali Anticoagulation Management Center (AMC).~      The objective of the protocol is to evaluate the efficacy and safety of Fiix-INR as a~     monitoring test compared to the current PT based assays (INR) used to monitor patients~     treated with VKA to prevent thromboembolism. The investigators will randomize 1200 clients of~     the AMC into two identically sized monitoring groups, Fiix-INR (test group) and INR (control~     group).~      The clinical endpoints to be studied include efficacy (arterial and venous thromboembolic~     event rate) and safety (bleeding events). Additionally, surrogate convenience endpoints will~     be studied such as test frequency and time within target range.~   "
152884|NCT01565226|"~     -  This will be an observational study. Respiratory data will be recorded using~          Capnostream20p. There will be no use in the recorded data for the medical care of the~          patients. Other clinical data will be captured in the CRF. Similar study is currently~          conducted in Bnai Zion MC since 2008. Thirty four (34) patients have been recruited~          without any adverse events.~        -  During the study the medical team will capture in the CRF the following: Blood gas and~          distal capnography values at time of sampling, ventilator settings at time of sampling.~        -  Changes made in the ventilation parameters, blood gas time and results, concomitant~          treatment (e.g. suction) and concomitant medication (respiratory related e.g.~          surfactant), vital signs all these will be retrieved from the patient's medical charts.~   "
152885|NCT01565213|"~     The purpose of this study is to compare the effects of CBT and MMI on the quality of life and~     relief of psychological symptoms of patients with common mental disorders or problems~     attending primary health care centre.~   "
152886|NCT01565200|"~     T-DM1 , which is a highly innovative but also expensive antiHER2 agent consisting in the~     coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent (maytansine~     derivate) has shown an encouraging antitumor activity evaluated by Recist criteria (35%~     objective response rate, 44% stable disease, 18% progressive disease) in patients with~     advanced HER2 positive Breast Cancer pretreated with several cytotoxic drugs, trastuzumab and~     lapatinib.~      Rationale I :For TDM1 to be active, the presence of an intact HER2 receptor is key since~     the internalization of the cytotoxic moiety depends on the binding of trastuzumab to the~     external domain of HER2.~      The zirconium 89 labelled trastuzumab PET/CT (or HER2 immunoPET/CT) is a non invasive test~     which shows promise in measuring HER2 expression (extracellular domain) for the entire~     disease burden and which could identify non responding patients prior to TDM1 administration.~      Rationale II: As for many such agents, it is desirable to identify early on (here with the~     use of FDG-PET/CT) which patients are unlikely to benefit from the therapy~   "
152887|NCT01565187|"~     A prospective multicenter study utilizing standardized instruments for the psychological~     assessment of hand transplant candidates pre and post-transplant as well as those candidates~     excluded for transplantation.~   "
152948|NCT01564381|"~     The investigators hope to learn if resveratrol supplementation can be beneficial for the~     cardiovascular system. Seeing that resveratrol is rapidly metabolized, the investigators are~     interested in learning if a novel form of resveratrol, ResA, which is a mixture of~     resveratrol with amino acid, may have greater bioavailability and lead to greater improvement~     in vascular function, compared to standard resveratrol supplement.~   "
152888|NCT01565174|"~     There is growing evidence of high rates of substance use disorders among individuals with~     psychotic disorders especially in young people with predisposition for psychosis. There is~     some genetic evidence that carriers of the valine158 allele of the~     catechol-O-methyltransferase (COMT) gene had increased risk to exhibit psychotic symptoms and~     to develop schizophrenia if they used cannabis by the age of 18. It was also shown that~     carriers of the COMT val/val genotype were most sensitive to THC-induced psychotic~     experiences but this was conditional on pre-existing susceptibility to psychosis. The~     investigators propose to use brain-imaging and molecular genetics to investigate whether~     genetic factors may contribute to the THC-induced dopamine release and possibly to cannabis-~     induced psychosis.~   "
152889|NCT01565161|"~     While childhood obesity rates may have plateaued in some US population subgroups, such as~     whites and those of higher socioeconomic status, overall rates of obesity remain high and~     racial/ethnic and socioeconomic disparities appear to be widening. Among the most promising~     approaches for childhood obesity prevention and management are interventions that begin early~     in life and that support change at the individual and community levels.~      The goal of this project is to develop and test an intervention delivered to racial/ethnic~     minority and low income parents of 2-5 year old children in their homes, designed to promote~     adoption of household routines and parenting strategies that are preventive of obesity. To~     achieve this goal, the investigators will work with community health centers in Boston,~     Cambridge, and Somerville to recruit families to participate in an individual-level~     randomized controlled trial. The investigators partner community health centers include the~     Roxbury Comprehensive Community Health Center, Dimock Community Health Centers, and the~     Cambridge Health Alliance (CHA).~      Participants will be randomized to receive either 1) mailed educational materials for the~     duration of the 6-month program (control), or 2) home-based health coaching visits and phone~     calls with a health educator, text messages, and educational materials promoting the adoption~     of household routines and target behaviors (intervention).~      The investigators goal is to evaluate the feasibility and effectiveness of the investigators~     designed intervention (as compared to the control condition) using baseline and~     post-intervention data. In order to do so, the investigators will assess change from baseline~     to post-intervention in the investigators key behavioral outcomes of interest, including~     adoption of three household routines:~        1. Regularly eating meals together as a family~        2. Obtaining adequate sleep~        3. Limiting screen-viewing time~   "
152890|NCT01565148|"~     -  To assess the safety of repeated iCo-007 intravitreal injections in treatment of~          subjects with diabetic macular edema as monotherapy and in combination with ranibizumab~          or laser photocoagulation~        -  To assess the change in visual acuity and retinal thickness on optical coherence~          tomography (OCT) from baseline to month 8 and month 12~   "
152891|NCT01565135|"~     The purpose of this study is to determine if a multimodal immunization program carried out in~     obstetrics and gynecology (ob/gyn) practices would be more effective in improving ob/gyn~     patients' immunization rates, specifically for Tdap (Tetanus, Diphtheria, Pertussis), HPV~     (Human papilloma virus), and influenza vaccines, than the usual care provided to patients in~     ob/gyn practices.~   "
152892|NCT01565122|"~     This multi-center, observational study will evaluate the clinical practice patterns, efficacy~     and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data~     will be collected from each eligible patient initiated on RoActemra/Actemra treatment by~     their treating physician according to approved label for up to 12 months from start of~     treatment.~   "
152893|NCT01565109|"~     It is estimated to 7300 the number of new cases of gastric cancer each year in France.~      According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU)~     administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma~     of the stomach and lower esophagus, clinical and experimental data are the neoadjuvant~     chemotherapy is a new standard treatment for operable gastric cancer. This treatment with a~     median survival of more than 3 years to obtain a hazard ratio of 0.75 in favor of~     chemotherapy arm (p = 0.009). The 5-year survival being 36% for patients treated with~     chemotherapy versus 23% for surgery alone. Progression-free survival was also significantly~     prolonged with a hazard ratio of 0.66.~      The proposed clinical study by Ajani et al shows that the combination of Docetaxel with the~     schema Cisplatin - 5FU provides greater clinical benefit and induces to consider the triple~     combination as a reference treatment in metastatic gastric cancer in patients under 65 years.~      Preoperative radiochemotherapy is expected to increase the rate of curative resections,~     reduce gastrointestinal and hematologic toxicity.~      Two studies evaluating the feasibility of preoperative RTCT in operable gastric~     adenocarcinoma with continuous 5GU (+ or - paclitaxel) and 45 Gy are available and the~     combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors.~      The NESC study, Phase II, proposes the following schema: 2 cycles of chemotherapy with~     Docetaxel - Cisplatin - 5FU then preoperative chemoradiation with oxaliplatin - continuous~     5FU and radiotherapy in locally advanced gastric adenocarcinoma stage III and IV~     non-metastatic administered before surgery.~   "
152894|NCT01565096|"~     The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to~     glimepiride on beta cell function and the cardiovascular risk profile in patients previously~     treated with Metformin monotherapy.~   "
152895|NCT01565083|"~     This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy~     of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line~     participants with metastatic or locally advanced HER2-positive breast cancer. Participants~     will receive pertuzumab and trastuzumab administered sequentially as separate intravenous~     (IV) infusions (followed by vinorelbine) and conventional sequential administration of~     pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.~   "
152896|NCT01565070|"~     Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in~     the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is~     produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient~     Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ®~     treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate~     knee osteoarthritis, which would decrease the immobility and isolation in older adults.~   "
152897|NCT01565057|"~     This comparative study is designed to compare the gastric layering and rates of emptying and~     by inference rates of digestion of two food emulsions. Two types of dairy based foods will be~     used, one which will sediment in the stomach and one that will not. On each of two study~     days, a total of 9 post drink MRI scans will be taken to assess gastric layering and~     emptying. Cannulation will allow blood samples to be taken periodically for subsequent~     analysis for the presence of specific digestion related hormones. A total volume of 36 ml of~     blood will be removed and volunteers will also be asked to complete a questionnaire at~     predetermined times to assess feelings of satiation.~   "
184594|NCT01148537|"~     The purpose of this study is to examine the effect of buprenorphine on QT interval corrected~     for heart rate (QTc) in healthy subjects.~   "
152898|NCT01565044|"~     Many patients retain upper-limb motor impairment following stroke. Most conventional~     rehabilitation techniques are aimed to improve motor intentional movement by repeated~     exercises. These techniques require attentional load and are responsible for significant~     fatigue that probably represents a limiting factor. Alternatively, the automatic control of~     action is now well documented. A rehabilitation method based on this principle could allow~     recovery of more natural movements.~      Hypothesis: Stimulating automatic motricity improves upper-limb motor skills compared with a~     rehabilitation technique based on intentional movements.~   "
152899|NCT01565031|"~     The optimal score to predict unfavourable outcome in well-controlled asthma patients who are~     undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is~     warranted to prospectively develop a prognostic system -easy to perform (suitable for use in~     the clinical rather the research setting)- for asthmatic patients in this clinical setting.~      HYPOTHESIS: A simple score system can accurately predict clinical deterioration of asthma in~     well-controlled patients who are undergoing a step-wise down-titration of their medication~     according to international guidelines.~      METHODS The investigators designed a prospective, multicenter, observational study at five~     centers in cities across Spain.~      The patients group (N = 225) will be evaluated to produce a clinical prediction rule for loss~     of control. The investigators will consider the following variables in the risk factor~     analysis: documented history of previous bronchial obstruction (FEV1/FVC < 70%), coefficient~     of variation (CV) of morning peak expiratory flow (PEF), history of exacerbations, fraction~     of exhaled nitric oxide (FENO), Asthma control test (ACT), ACT item 3 and adherence.~      The score model will be prospectively validated in an independent set of 113 patients.~   "
152900|NCT01565018|"~     To investigate and compare the drug amount delivered to the body after each single~     administration of Rotigotine patch with 2 different formulations in healthy Japanese~     subjects.~   "
152901|NCT01565005|"~     The purpose of this study is to:~      I. Compare neuroradiological phenotype and cognitive functioning of MCPH patients caused by~     ASPM mutations already characterized and published (Passemard et al. 2009a) with other~     MCPH-related patients (patients with MCPH1, WDR62, CDK5RAP2, CEP 152, CENPJ, STIL, or PCNT~     mutations)~      II. Describe the neuro-radiological and cognitive phenotype of microcephalic patients~     suffering from Fanconi anemia, and compared them to subjects with:~        -  Fanconi anemia but normal OFC (head circumference)~        -  MCPH patients~        -  Healthy control subjects Our hypothesis is that mutations in genes responsible of~          microcephaly impact differentially cortical brain development and functioning~   "
152902|NCT01564992|"~     This observational study aims at identifying gene modifiers of Parkinson Disease (PD) and of~     treatment response and adverse events of antiparkinsonian drugs. Six hundred PD patients will~     be followed annually for up to 5 years. A biological collection will be associated with a~     full clinical assessment of motor and non motor symptoms, medical and treatment history,~     environmental factors. The association between candidate gene polymorphisms and disease or~     treatment complications will be analyzed.~   "
152903|NCT01564979|"~     The purpose of this study is to determine whether pretarsal and preseptal techniques of~     Botulinum toxin type A injection have any effect on tear functions.~   "
152904|NCT01564966|"~     -  A reduce in renal mass may result in remnant single nephron hyperfiltration, with~          associated proteinuria and an accelerated loss of kidney function.~        -  Live-donor kidney transplantation is generally considered the best choice for patients~          who have renal failure and are awaiting transplantation, because these kidneys function~          better than kidneys from deceased donors, and waiting times for deceased-donor~          transplants are long~        -  Although several studies have shown that kidney donation has low short-term morbidity~          and mortality, the data on long-term outcomes are much less complete.~        -  This study is designed to prospectively evaluate the effects of unilateral nephrectomy~          on cardiovascular-renal functions of donors after living kidney donation: the~          development of hypertension, albuminuria, renal failure, inflammatory and endothelial~          changes.~   "
152905|NCT01564953|"~     The aim of this study was to investigate the associations between serum concentrations of~     vitamin D, Magnesium and Calcium in Chronic obstructive pulmonary disease patients and the~     potential impact of these parameters on lung function and quality of life.~   "
152906|NCT01564940|"~     The purpose of this study is to obtain subjective feedback in a home use environment~     regarding usability and ease of use of the applicator and conception cap and the instructions~     for use. Data will be collected and evaluation to determine if the usability requirements of~     the conception system as determined by the usability specification have been met. The study~     will not involve sexual intercourse or delivery of any fluids to the cervix. The study will~     only involve use of the applicator to insert the cervical cap into the vagina, track it to~     the cervix and prepare and release the cervical cap (with removal string attached) onto the~     cervix. The conception cap will remain in place for no more than 6 hours.~   "
152907|NCT01564927|"~     The aims of the study are to investigate the physiological responses associated with deqi~     during stimulation of the LI11 and LI4 acupuncture points and the correlation between the~     intensity of the deqi sensation to such responses.~   "
152908|NCT01564914|"~     The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with~     recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF~     therapy)~   "
152909|NCT01564901|"~     This prospective, observational, multicenter study will assess the efficacy and safety of~     RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to~     severe rheumatoid arthritis and an inadequate response to previous disease-modifying~     antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.~   "
152910|NCT01564888|"~     Evaluating the effect of ulnar artery compression while pressing on radial artery to stop~     bleeding, in maintaining radial artery potency, after cardiac catheterization through the~     radial artery. We prospectively plan to compare 3000 patients referred for cardiac~     catheterization, randomized into two groups, one group receiving radial artery compression~     for stopping bleeding, in a standard fashion following best practices, and the other group~     receiving radial artery compression using standard best practices and ulnar artery~     compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure~     to evaluate its potency, using plethysmography.~   "
152911|NCT01564875|"~     Study design~        -  Multicenter, double-dummy, double-blinded, randomized, Phase 4 study~        -  Patients will be randomized to either a study group or a control group in a 1:1 ratio,~          and will be orally administered the assigned drugs~      Study Objective~      -The study is designed to demonstrate that efficacy and safety of morning dosing of Simvast~     Controlled Release (CR) Tab is not inferior to evening dosing of Zocor Tab in patients with~     stage 3,4,5 chronic kidney disease with hyperlipidemia~      Primary objective~      -to assess the percent change of LDL-C at Week 8 from baseline in Chronic Kidney Disease(CKD)~     stage 3,4,5 with hyperlipidemia subjects.~   "
152912|NCT01564862|"~     The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on~     cognitive dysfunction in patients with major depressive disorder.~   "
152913|NCT01564849|"~     An explosion of interest in the numerous therapeutic properties of Punica granatum over the~     last decade has led to numerous in vitro, animal, and clinical trials. Pomegranate is a~     potent antioxidant, superior to red wine and equal to or better than green tea. In addition,~     anticarcinogenic and anti-inflammatory properties suggest its possible use as a therapy or~     adjunct for prevention and treatment of several types of cancer and cardiovascular disease.~     Because of pomegranate's antimicrobial properties, it may aid in preventing infection by~     dental pathogens, pathogenic E. coli O157:H7, and antibiotic-resistant organisms such as~     methicillin-resistant Staphylococcus aureus (MRSA) Pomegranate's effect on bacterial~     pathogens has only been tested in vitro, however, necessitating human trials to refute or~     substantiate any clinical effect.~      The possibility that pomegranate extracts may also have an effect on several other disease~     processes, such as Alzheimer's and obesity, underscores the need for more clinical research.~     Currently, numerous clinical trials are in progress exploring the therapeutic potential of~     pomegranate extracts.~      Aim The investigators want to evaluate the effect of Punica granatum components on Chronic~     sinusitis, nasal polyps and chronic rhinitis.~   "
152914|NCT01564836|"~     This prospective study is performed to identify safer and more concrete indicators of~     successful discontinuation and explore contributing factors for sustained undetectable~     transcript~   "
152915|NCT01564823|"~     The present study objective is evaluate Adalimumab efficacy versus Azathioprine efficacy on~     prevention of endoscopic recurrence (Rutgeerts Index= 2b, 3 or 4) in Crohn´s Disease patients~     after 52 weeks of treatment.~   "
152916|NCT01564810|"~     In this study, the investigators assessed the effect of Cetuximab in combination with~     chemotherapy in the treatment of unresectable metastatic colorectal cancer.~   "
152917|NCT01564797|"~     The aims of the study are to investigate~        1. the effects of an intervention vs. control on levels of glycosylated haemoglobin~          (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c~          at baseline (>6.0%). Glycosylated haemoglobin provides an indication of blood sugar~          levels over the past 3 months. Elevated hA1c levels are seen in diabetics and~          pre-diabetics.~        2. the effects of the intervention vs control on consumption of fresh fruit and vegetables~        3. the effects of the intervention vs control on levels of physical activity~   "
152918|NCT01564784|"~     This study will compare the efficacy, in terms of complete responses and overall survival, of~     inotuzumab ozogamicin versus investigator's choice of chemotherapy.~   "
152919|NCT01564771|"~     Serotype distribution and estimation of antimicrobial resistance in S. pneumoniae isolates~     and anticipated PCV7 and PCV13 coverage is difficult in Greece, because invasive isolates~     collected each year are limited and depict a certain proportion of patients who have easy~     access to tertiary care or have underlying medical reasons which necessitate inpatient care.~     It is also probable that the real burden of pneumococcal disease is not well estimated~     especially among adults. New additions in the laboratory setting such as the pneumococcal~     urine antigen assay (Binax NOW®) and the Urinary Antigen Diagnostic Assay (Luminex) for the~     detection of 13 serotype specific polysaccharides in human urine developed by Pfizer might be~     helpful in identifying more pneumococcal infections compared to the previous years. This NIS~     is based on the unmet scientific need to describe the serotype distribution and the~     resistance profile of isolates from X-Ray confirmed CAP in the present circumstances.~   "
152920|NCT01564758|"~     The purpose of this study is to determine if Linezolid is safe for adult Filipino patients~     diagnosed with gram positive infections.~   "
152921|NCT01564745|"~     In our knowledge there is only few data about the cough determinants in mechanically~     ventilated patients. However some failure of extubation is due to inefficiency cough. In~     order to determine some determinants of cough, the investigators propose to evaluate~     systematically different physiological parameters before and after extubation.~   "
152922|NCT01564732|"~     The purpose of this study is to compare plicated laparoscopic adjustable gastric banding~     (PLAGB) to standard laparoscopic adjustable gastric banding (SLAGB) in a prospective~     randomized clinical trial. We hypothesize the plicated procedure will provide greater short-~     and long-term excess weight loss than the standard procedure. There exists little prospective~     randomized data regarding this topic and the recent position statement from the American~     Society for Metabolic and Bariatric Surgery (ASMBS) encourages this type of study. Further~     information on background and design of this study are provided in the detailed description.~   "
152923|NCT01564719|"~     This study seeks to test a two-year intervention designed for United Methodist clergy. The~     intervention consists of: the stress reduction program Williams LifeSkills, adapted for~     clergy; the 10-session online weight loss program Naturally Slim Foundations plus its~     7-session online booster program, Naturally Slim Advanced; monthly phone conversations with~     Wellness Advocates who function as health coaches; and three in-person workshops that cover~     the theology of the body and incarnation and provide the religious rationale for caring for~     the mind and body. Participants were randomly assigned to one of three cohorts, all of which~     will eventually receive the intervention but which differ by intervention timing, thereby~     building in a randomized waitlist control group. The investigators hypothesize that~     intervention participants will achieve reductions in metabolic syndrome, depression, and~     stress, and achieve improvements in quality of life and spiritual well-being, compared to the~     waiting control group participants.~   "
152924|NCT01564706|"~     This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed~     throughout the body.~   "
184706|NCT01147055|"~     The purpose of this study is to estimate the effect of multiple doses of Rifampin on the~     single dose pharmacokinetics of Crizotinib in healthy volunteers.~   "
152925|NCT01564693|"~     The pathogenesis of cancer anorexia is complex and multifactorial. However, a number of~     consistent and robust evidence point to a prominent role for the central nervous system. In~     particular, the hyperactivation of the immune system, due to tumour growth, causes a systemic~     inflammatory response primarily mediated by pro-inflammatory cytokines. At the central level,~     inflammatory response profoundly alters the activity of the hypothalamic nuclei, which are~     involved in the regulation of energy homeostasis. In particular, pro-inflammatory cytokines~     inhibit prophagic neurons activity, while enhance the activation of the anorexigenic neurons.~     Although supported by compelling experimental evidence, it should be acknowledged that this~     pathogenic hypothesis has not been confirmed yet by human studies.~      Aim of the present study is to determine the specific pattern(s) of the brain activation~     after assumption of a standard meal in both anorexic and non-anorexic cancer patients to~     reveal potential differences, which will be correlated with the levels of concurrently~     measured circulating pro-inflammatory cytokines. The results obtained would help in assessing~     the role of the central nervous system and, in particular of the hypothalamus, in the~     pathogenesis of cancer anorexia.~   "
152926|NCT01564680|"~     Background: The aim of this prospective, randomized, double-blind study is to determine the~     most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain~     relief after lower abdominal surgery.~      Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were~     randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol~     1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam~     group). Additionally pain was treated postoperatively using morphine patient-controlled~     analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine~     consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours~     postoperatively.~   "
152927|NCT01564667|"~     Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either~     Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a~     placebo control condition not designed to change attention patterns. Outcome measures will be~     PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological~     interviews and questionnaires. Participants will also be invited to participate in~     physiological testing before and after receiving AMBT or placebo to serve as additional~     outcome measures and assess brain functioning, heart rate, and muscle tension.~      The investigators expect to see significant PTSD symptom reduction in the Attention Bias~     Modification Treatment (ABMT) group relative to the placebo control group in which no~     symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we~     will offer active ABMT to those participants randomly assigned to the placebo arm if they~     would like to receive the treatment.~   "
152928|NCT01564654|"~     This study involves retrospective collection of data regarding the first approximately 100~     iTotal Knee Replacement System surgeries and their short term outcomes at a small set of~     centers throughout the US.~   "
152929|NCT01564641|"~     To evaluate the ConforMIS iDuo G2 implant~   "
152930|NCT01564628|"~     The purpose of the study is to optimize an already existing algorithm for diagnosing~     atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).~   "
152931|NCT01564615|"~     The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the~     occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants.~   "
152932|NCT01564602|"~     The main objective of this trial is to assess the efficacy and safety of single port-access~     laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood~     loss and hospital stay will be record, respectively. The pain score is based on the visual~     analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours~     after surgery.~   "
152933|NCT01564576|"~     The aim of the present study is to prospectively assess whether deep neuromuscular blockade~     (NMB) (zero response to train of four and a post tetanic count of no more than 10 responses~     using a nerve stimulator monitoring) until the end of surgery, followed by sugammadex~     (bridion®) reversal is superior to the present practice of gradual NMB reduction at the end~     of surgery followed by neostigmine (Prostigmin®, Vagostigmin®) reversal, in patients~     undergoing laparoscopic sleeve gastrectomy. The investigators hypothesize that providing deep~     NMB throughout the procedure creates better conditions for surgery, while reversal of deep~     NMBwith sugammadex (bridion®) will enable quick and full reversal of relaxation and fewer~     postoperative respiratory events as compared to neostigmine (Prostigmin®,~     Vagostigmin®)reversal. Participants will be followed for the duration of hospital stay, an~     expected average of 7 days.~   "
152934|NCT01564563|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in~     patients having undergone a hematopoietic stem cell transplantation.~   "
152935|NCT01564550|"~     In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics~     in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The~     kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The~     investigators hypothesis is that the investigators will find an increased VLDL1 production in~     type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators wish~     to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males, where~     the investigators expect less variance in VLDL production when the subject is given an~     isocaloric diet.~   "
152936|NCT01564537|"~     The purpose of this study is to determine whether the addition of oral ixazomib to the~     background therapy of lenalidomide and dexamethasone improves progression free survival (PFS)~     in participants with relapsed and/or refractory multiple myeloma (RRMM).~   "
152949|NCT01564368|"~     RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI)~     and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating~     how well patients with breast cancer respond to treatment.~      PURPOSE: This research trial studies DWI and DCE-MRI in assessing treatment response in~     patients with breast cancer undergoing neoadjuvant chemotherapy.~   "
153214|NCT01560884|"~     The purpose of this trial is to study safety, tolerability, and phosphate binding capacity of~     Renazorb (SPI-014) in healthy volunteers before conducting trials in patients with renal~     failure. Renal excretion of phosphate is expected to decrease and fecal excretion of~     phosphate is expected to increase after treatment.~   "
152937|NCT01564524|"~     Traumatic facial injuries, especially those sustained in military combat, are characterized~     by destruction of bone and soft tissue. While the bony structures of the face can be~     reconstructed, it is difficult to return the soft tissue back to its original form. Many~     times, fat grafting, a common cosmetic and reconstructive procedure, is used in hopes of~     improving the soft tissue deformity. Fat grafting is a procedure in which a person's own fat~     is taken from areas throughout the body, usually the thighs or abdomen, with a small~     liposuction tube. The fat is then transferred into the area that has lost volume or fullness.~     The fullness of the soft tissue area may decrease over time because the transferred fat can~     be reabsorbed by the body. Altering the current fat grafting procedure, slightly, could lead~     to less reabsorption and a lasting fullness of the soft tissue area outcome of the fat graft~     procedure.~      We are conducting this research study to help us improve the surgical treatment of people who~     have suffered facial soft tissue loss as a result of trauma. The goal of this research study~     is to see how each person's fat grafts will maintain the fat over time and to measure the~     quality of life during a 9 month post-surgical follow-up period. The total duration of~     participation is approximately 11 months.~      In this study, we will concentrate the fat in the fat grafting procedure to determine whether~     this process will maintain the fat over time. The areas treated with enhanced fat grafts will~     be compared with areas treated with standard of care fat grafts. At least two areas of your~     face will be treated with fat grafts, (standard of care fat grafts and concentrated fat~     grafts).~   "
152938|NCT01564511|"~     Multiple Sclerosis is a very disabling disorder in young adult patients leading to an~     important limitation in daily life activities and social participation. Among of the~     different causes of disability in MS patients gait impairments, fatigue and balance disorders~     can be considered as the main concerns. Thus, gait restoration in patients with MS is the one~     of the primary objective of rehabilitation and often influences whether a patient can return~     home or to work. Even if potentially innovative treatments like treadmill training have been~     proposed, nowadays the role of robotic assisted locomotion rehabilitation has not been~     extensively studied in patients with MS.~   "
152939|NCT01564498|"~     The hypothesis is that richly coloured purple vegetables, rich in polyphenolic compounds~     including anthocyanins will have higher antioxidant and other biological activities, than~     more lightly coloured versions of these foods. Diets of human subjects will be modified to~     allow consumption of 200-300 g of raw carrots or cooked potatoes. Participants will be~     randomized to consume either orange or purple carrots, or white or purple potatoes. They will~     consume these diets for 12 weeks and bioavailability of polyphenolics will be examined as~     well as anthropometry and blood biochemistry for changes in risk factors associated with~     cardiovascular disease.~   "
152940|NCT01564485|"~     This study looked at the role of cardiac CT in improving risk factor control in those with~     diabetes.~   "
152941|NCT01564472|"~     The objective of this study is to validate the ability of the Sleepware G3 polysomnography~     software platform to correctly identify and score sleep related events.~   "
152942|NCT01564459|"~     The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the~     treatment of painful diabetic neuropathy (PDN) in adults.~   "
152943|NCT01564446|"~     Background and Significance: Adverse drug events (ADE) are the most common of all healthcare~     associated adverse events. Transitions between inpatient and ambulatory care can lead to ADE~     and avoidable healthcare utilization affecting up to 20% of patients. Insufficient monitoring~     has been identified as a particularly common cause of preventable and ameliorable ADE. The~     Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has called for a~     process to accurately and completely reconcile medications across the continuum of care.~     Inpatient computerized medication reconciliation tools have shown great potential, but little~     is known about successful medication reconciliation strategies immediately post-discharge.~     One promising solution to outpatient medication reconciliation is the use of secure~     electronic communication (SEC) between patients, accessing their personal health record via a~     web portal, and providers within an electronic health record. Surveys have consistently found~     that patients want to communicate with their primary care providers via SEC, and SEC is~     rapidly becoming a standard feature in electronic health records. A SEC-based approach to~     outpatient medication reconciliation following hospital discharge has the potential to~     improve patient safety, but important questions must be addressed, including: What~     information needs to be included in the SEC? What elements of the SEC are essential to its~     design? How can SEC be best incorporated into the workflow of the primary care office~     practice? Will patients and physicians find this approach acceptable? To address these~     questions, we propose a one-year pilot study at VA Boston with the following specific aims:~      Aim 1: To evaluate the primary care environment's receptivity to secure electronic~     communication (SEC) for medication reconciliation and design a prototype SEC. We will use~     qualitative methods to characterize the primary care clinic environment - the physical space~     and facilities, the workflow, the resources, as well as the knowledge, attitudes and skills~     of staff and, most importantly, the patients. Specific approaches will include in-depth~     interviews, direct ethnographic observations, and visualization methods Aim 2. To develop a~     prototype SEC for medication reconciliation through a participatory design process, involving~     primary care clinicians, staff and patients working collaboratively with the research team,~     and to test the usability and acceptability of the prototype SEC among a sample of patients~     and primary care clinicians.~      Research and Development Plan: With extensive experience in designing and evaluating health~     care informatics innovations, we have assembled a multi-disciplinary team with expertise from~     primary care internal medicine, clinical informatics, health services research, qualitative~     research, clinical pharmacy, nursing and industrial engineering. This team will carry out a~     formative evaluation and develop a prototype of a secure electronic message to facilitate~     medication reconciliation following hospital discharge. The proposed CIMIT project will~     leverage the resources and expertise of the e-Health QUERI (a national VA program for~     innovation and evaluation of the VA's e-Health programs) at VA Boston and other participating~     VA facilities nationwide. The figure below shows a very rough conceptualization of the SEC~     that will guide the qualitative research and participatory design of the prototype. This~     project will lay the foundation for a future rigorous evaluation of this approach to~     medication reconciliation and improving patient safety.~   "
152944|NCT01564433|"~     Cerebral Palsy (CP) describes a group of chronic conditions affecting body movement and~     muscle coordination caused by damage to one or more areas of the brain, usually occurring~     during fetal development or infancy. One of the most disabling mobility impairments in CP is~     gait impairment, clinically characterized by reduced speed and endurance, as well as reduced~     step, stride length and toe clearance during gait.~      Recently, gait rehabilitation methods in patients with neurological impairment have relied on~     technological devices, which drive the patient's gait in a body-weight support condition and~     emphasize the beneficial role of repetitive practice. Early studies in gait rehabilitation in~     patients with CP were carried out by using partial body-weight support treadmill training~     (PBWSTT) and robotic-assisted treadmill therapy. Despite their potential, these technologies~     have practical limitations in their routine application.~      More recently, several studies have focused on the use of a new electromechanical gait~     trainer (Gait Trainer GT I; Reha-Stim, Berlin, Germany) in adult patients who have~     experienced a stroke. They have shown that training with this device may significantly~     improve gait performance. Despite the clinical impact of this new rehabilitative procedure,~     to date, no studies have been conducted on its use in children with CP.~   "
152945|NCT01564420|"~     The currently available data are insufficient to develop a model that achieves optimum~     morphine dose individualization at the postoperative period of coronary artery bypass~     grafting (CABG). Therefore, the objective of the study was to apply a PK/PD model that could~     justify morphine consumption, drug plasma concentration and pain intensity during the~     postoperative period after CABG and evaluate the post operative pain.~   "
152946|NCT01564407|"~     The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the treatment~     of stable, restrictive scars in subjects who have suffered a burn injury. Evaluation will be~     achieved through regular assessment of adverse events, vital signs, blood work monitoring and~     laboratory analysis cellular properties of the scar through biopsy.~      The secondary objectives of this study are to evaluate improvement in symptoms of scars~     including reduced pain, discomfort and itching, improvement in mobility and daily function,~     improvement in appearance and scar texture.~   "
152947|NCT01564394|"~     Aim 1: Assess the feasibility, safety and efficacy of a Qigong intervention in elderly~     prostate cancer survivors.~      Describe participation, retention, and adherence rates and assess reasons for participation,~     attrition, and non-adherence.~      Identify effective recruitment and retention strategies. Ascertain participants' level of~     satisfaction and additional perceptions of the experimental and control interventions,~     perceived study burden, study design, and implementation.~      Aim 2: Provide preliminary data on potential effects of Qigong vs. non-aerobic stretching~     exercises on fatigue, psychosocial outcomes, and health-related quality of life in~     preparation for a future R01 application for a larger, definitive randomized controlled~     trial. Hypothesis: Qigong participants will have improved fatigue levels, quality of life,~     and related psychosocial and health outcomes compared to those randomized to the non-aerobic~     stretching group.~   "
153228|NCT01560702|"~     Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.~   "
152950|NCT01564355|"~     Chronic rhinosinusitis (CRS) is an inflammatory condition of the nose and sinuses. It affects~     about 5 to 10% of Canadians. Patients suffer from congestion in the nose and sinuses, nasal~     discharge, pressure in the face, and a reduced sense of smell. This affects people's~     enjoyment of life. Medical management uses sprays or pills to treat these symptoms but for~     some patients sinus surgery is needed. This type of surgery is called endoscopic sinus~     surgery (ESS).~      There is no single correct approach to take care of patients after sinus surgery. Most~     experts would use a nasal spray and a short-course of oral steroid pills to reduce sinus~     swelling and minimize complications related to scarring.~      Steroid-eluting nasal spacers are devices placed inside the sinus during surgery and slowly~     release topical steroids into the sinuses better than steroid sprays. These spacers have~     been shown to improve results following sinus surgery. When using these special spacers,~     there may no longer be a need for oral steroid pills following surgery. This would help to~     avoid potential side effects associated with these medications.~      The purpose of this study is to find out whether taking oral (systemic) steroid pills~     following sinus surgery is necessary to improve surgical results, now that steroid-eluting~     nasal spacers are commonly used during surgery.~   "
152951|NCT01564342|"~     This study is designed to compare the infection rates in wounds irrigated with sterile normal~     saline to those irrigated with chlorinated tap water. The hypothesis is that the wound~     infection rate subsequent to irrigation with tap water is not significantly different than~     the infection rate for wounds irrigated with sterile normal saline.~      Inclusion criteria are patients older than 1-year of age who present to the emergency~     department with a soft-tissue laceration requiring repair. Exclusion criteria include~     patients with any underlying immunocompromising illness, current use of antibiotics, puncture~     or bite wounds, underlying tendon or bone involvement, or wounds more than nine hours old.~      Patients are randomized to have their wounds irrigated either with tap water or sterile~     normal saline prior to closure, controlling for the volume and irrigation method used.~     Structured follow-up is completed at 48 hours and 30 days to determine the presence of~     infection.~      The primary outcome measure is the difference in wound infection rates between the two~     randomized groups.~   "
152952|NCT01564329|"~     To evaluate the change of blood perfusion before/after the use of Endostar, discuss the time~     sequence of Endostar TM in treating advanced lung adenocarcinoma in normalization window~     period.~   "
152953|NCT01564316|"~     Using to method of Proteomics, for aims to conquer intractable disease, try to access variety~     experiment. Biomarker is necessary to develop new diagnosis method and target of treatment.~   "
152954|NCT01564303|"~     CIAKI is a common iatrogenic. Up to date the suggested treatments for CIAKI are partially~     effective and have not been approved by the Food and Drug Administration yet. The lack of~     effective nephroprotective drug for CIAKI, emphasizes the need not only for additional new~     drugs but also for new strategies that might also clarify CIAKI pathophysiology. To the best~     of our knowledge, the potentially beneficial effect of carnitine and PDE5 inhibitors on CIAKI~     prevention has not been examined, so far.~   "
152955|NCT01564290|"~     The purpose of this study is to determine the effect of probiotic yogurt in acute watery~     diarrhea in children. The investigators will compare the effect of two different probiotics~     products.~   "
152956|NCT01564277|"~     This randomized phase II trial studies how well giving rasburicase together with allopurinol~     works in treating patients with hematologic malignancies. Rasburicase may reduce the level of~     uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more~     effective in treating hematologic malignancies when given together with or without~     allopurinol.~   "
152957|NCT01564264|"~     The purpose of this study is to determine if there is a difference between the lymphatic~     drainage of the cervix and corpus of the uterus after injecting a radiocolloid in the cervix~     and blue dye in the corpus of the uterus and to investigate the identification rate of~     sentinel nodes using this technique in patients with cancer of the uterus.~   "
152958|NCT01564251|"~     This open-label, multicenter, Phase I, dose-escalation study will evaluate the safety,~     tolerability, and pharmacokinetics (PK) of GDC-0575 administered alone or in combination with~     gemcitabine in participants with refractory solid tumors or lymphoma. In Stage 1, cohorts of~     participants will receive multiple ascending oral doses of GDC-0575 alone or in combination~     with intravenous gemcitabine. In Stage 2, participants will receive GDC-0575 orally in~     combination with intravenous gemcitabine at or below the maximum tolerated dose determined in~     Stage 1. Anticipated time on study treatment is until disease progression or unacceptable~     toxicity occurs, up to approximately 5 years.~   "
152959|NCT01564238|"~     Optimal calcium retention is important for building bone mass within the genetic potential, a~     key to reducing risk of osteoporosis later in life. Calcium retention is high during the~     rapid growth period. The investigators know that urinary calcium is affected by sodium intake~     but the investigators do not know the effects of sodium intake during the growth spurt or the~     differences in calcium retention between blacks and whites. Our hypothesis was that a high~     dietary sodium increases the calcium intakes required for optimal calcium retention in both~     black and white adolescent girls. The investigators tested calcium retention while girls~     consumed a low and high sodium diet during three week periods. The subjects were housed in a~     Purdue fraternity house during the summer and they were supervised at all times by trained~     staff. During the summer of 1999, subjects consumed diets with 2 levels of dietary Na+ with a~     fixed diet low in calcium. On the next summer, they switched to a high calcium diet. Subjects~     collected fecal and urine daily for 20 days. Other measurements included daily body weight,~     blood pressure every other day, blood sample at the end of each session. Baseline measures~     included bone mass, self-assessment of pubertal development, a physical examination and diet~     history.~   "
152960|NCT01564225|"~     Following discussions with the FDA, a Phase 1 safety study is being initiated in X-Linked~     Hypohidrotic Ectodermal Dysplasia (XLHED)-affected adults to develop safety and exposure data~     for EDI200 in anticipation of dosing XLHED-affected neonates. Selecting XLHED-affected adults~     for this study provides a genetic match and biologic relevance to XLHED-affected neonates.~     Both males and females will be enrolled, providing safety experience with EDI200 that will~     inform the planned neonate study as well as supportive data for potential future trials of~     antenatal EDI200 administration.~   "
152961|NCT01564212|"~     With approval of the IRB at the Cleveland Clinic and written informed consent, the~     investigators propose to study up to 20 healthy volunteers in the protocol below as this will~     allow for drop-outs. As the investigators believe that 10 volunteers will provide sufficient~     power to detect clinically-meaningful differences between laminar air flow treatments.~      The study has been designed to find out whether heat loss increases significantly in laminar~     air flow operating rooms. Furthermore the investigators will find out whether active warming~     minimizes this heat loss. Increased heat loss increases the amount of perioperative~     hypothermia. It has been shown that perioperative hypothermia is associated with severe~     complications such as an increased incidence of surgical wound infections. On the other hand~     laminar air flow is explicitly used to decrease air-borne infections. Our study results will~     help to optimize thermal management of orthopedic patients.~   "
152962|NCT01564199|"~     The objective of the study is to assess the extent to which the charcoal prevents the~     absorption of salmeterol and fluticasone via the GI tract. The assessment will be based on~     comparing the pharmacokinetic parameter area under the concentration-time curve (AUCt).~   "
152963|NCT01564186|"~     The purpose of this study is to evaluate the effects of MultiPoint Pacing (MPP) on cardiac~     hemodynamics assessed by pressure-volume loop during MPP at implant. NYHA functional class~     assessment and echocardiographic measurements are performed at 3 months and 12 months~     post-implant to characterize long-term effect of MPP.~   "
152964|NCT01564173|"~     The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at~     each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with~     impaired LV function undergoing epicardial ablation and mapping procedure. Hemodynamic~     function will be assessed during a pacing protocol with a pressure catheter inserted in the~     LV.~   "
152965|NCT01564160|"~     A marine lipid oil extract isolated from the New Zealand Greenshell® Mussel, Perna~     canaliculus (P. canaliculus), contains a unique synergistic blend of marine fatty acids.~      The objective of the this study is to evaluate the acute (5-hour) and chronic (21-day)~     bioavailability of a fixed dose of PCSO-524 compared to a fish oil product in a population of~     healthy adult participants.~   "
152966|NCT01564147|"~     Taking into account the recommendations of the Health Authority [1] and the application of~     patients' associations, we have structured a course of therapeutic education includes three~     stages for patients with rheumatoid arthritis and followed at Nantes University Hospital.~     Step 1: initial interview with a nurse patient education for diagnosis and education with the~     patient to choose three subjects from among 10 offered him problematic; Step 2: Orientation~     in an educational path that provides access to 6 months group workshops (3 maximum) and / or~     interviews tailored to the three selected topics; Step 3: final interview with a nurse said~     therapeutic education formative assessment to take stock. The main objective of our work is~     to ensure that the patient finds it easier solutions to the three problematic topics him~     after 6 months of education after six months without treatment.~   "
152967|NCT01564134|"~     An interventional study will be performed in subjects aged 1-65 years old to evaluate effects~     of different doses of hepatitis B vaccines in low or non-response population.~   "
152968|NCT01564121|"~     The giant cell tumor (GTC) is an aggressive benign bone tumor, growing at the~     metaphyseal-epiphyseal regions of long bones, especially around the knee and the distal~     radius.It is responsible for bony destruction in para-articular zone fracture and leading to~     the breakdown and destruction of the underlying joint.~      Histologically, the tumor cell contains a contingent of monocytic cells round, a contingent~     of giant type cell of type osteoclastic responsible for bone resorption that accompanies~     these tumors and a contingent of lengthened cells fibroblast-like considered to be contingent~     tumor.~      The treatment is exclusively surgical; or by resection of the lesion which takes away tumour~     and its environment, solution which, if it prevents local recurrence, imposes an important~     bony and articular reconstruction, always limited and deteriorating rapidly over time in~     these young patients; or by curettage of lesion, by hollowing-out of the bone, creating a~     hole which it will be necessary to fill up by a bony grafting or a substitute of the bone~     (cement). This last solution, if it preserves a better function, exposes at risk of local~     recurrence,putting into play the prognosis of articulation near, most often the knee.Despite~     different local adjuvants treatments used during surgical operation, after having curetted~     the cavity and before filling it up, the recidivism rates vary from 12 % to 41 % (average 25~     %) in literature.~      The beneficial effect of the adjuvants therapeutics suggests the concept broadly accepted by~     a tumoral microscopic residual at the origin of the local recidivism .Biphosphonates (BP) is~     molecules which settle in vivo on the hydroxyapatite of the bone; they inhibit the~     recruitment of the osteoclast forerunners and the activity of mature osteoclast. Besides,~     biphosphonates containing some nitrogen (N-BP), leads to the apoptose of mature osteoclast.~     These molecules also have a direct effect on tumor cells , causing apoptosis of neoplastic~     cells of myeloma, of breast cancer. Clinical controlled studies confirm the experimental data~     of N-BP. Two work also showed their effect on osteoclasts and stroma cells of tumours with~     giant cells but no clinical study assessed potential on the prevention of the local~     recurrence.~      The investigators offer a study phase 2 of the effectiveness of N-BP (acid zoledronique) on~     the prevention of the local recurrence of tumours with primary huge cells after surgical~     treatment by curettage - filing by a surgeon referent in oncologic orthopedic surgery.~      Number of patients: 24~   "
152969|NCT01564108|"~     Anti-vascular endothelial growth factor (VEGF) treatments show great promise in the treatment~     of a variety of retinal diseases. This study addresses a condition which affects a large~     number of our patients in whom the investigators face difficult management decisions. These~     patients with uveitis are severely disabled with visual loss related to cystoid macular~     oedema (CMO) and few options remain when standard treatment has either failed or is~     contraindicated.~      The concentration of VEGF is increased in the eyes of patients with uveitis. Our hypothesis~     is that a series of injections of Ranibizumab may be an effective treatment for CMO. It is~     hoped that anti-VEGF therapy will have fewer side-effects than existing therapies and will be~     more effective in improving quality of life by reducing macular thickening and restoring~     visual function.~   "
152970|NCT01564095|"~     Utilisation of extended criteria donors due to critical organ shortage contributes to~     increased ischemia reperfusion injury as well as mortality following liver transplantation.~     Experimental data show protective effects on hepatic ischemia reperfusion injury (IRI) using~     the calcineurin inhibitor Tacrolimus applied intravenously or directly as a hepatic rinse.~     Moreover clinical data indicate a protective role of a Tacrolimus rinse in human liver~     transplantation when using normal, healthy grafts. The effects of Tacrolimus on hepatic~     injury in extended donor criteria (EDC) liver grafts remain unclear. Therefore, the aim of~     the present study is to examine the effects of a Tacrolimus ex vivo rinse (20 ng/ml) on~     cellular injury after transplantation of marginal liver grafts exhibiting 2 or more EDCs~     according to Eurotransplant's definition of EDC grafts.~   "
152971|NCT01564082|"~     Patients presenting for elective surgery will be randomized to having the breathing tube~     inserted partly into the throat prior to GlideScope insertion, or having it inserted fully~     after GlideScope insertion.~   "
152972|NCT01564069|"~     Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain~     will report no improvement treatment efficacy when compared to patients with chronic pain~     managed with oral or systemic opioid therapies. Our secondary hypothesis is that patients~     with intrathecal delivery systems for chronic non-cancer pain will report no improvement in~     treatment efficacy when compared to patients with chronic pain who are managed with~     non-opioid therapies.~   "
152973|NCT01564056|"~     The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall~     survival for elderly patients with breast cancer, in a sub group with a high risk of relapse~     according to Genomic Grade test.~   "
152974|NCT01564043|"~     Higher levels of physical activity are associated with better functional status, fewer~     hospital admissions, and lower mortality. The investigators studied the feasibility and~     safety of a novel program that combines a pedometer with a website to increase walking. This~     is a pilot study.~   "
152975|NCT01564030|"~     Solid food or fluid residue in the stomach is always a major concern when patients need~     medical procedures under sedation or general anesthesia, due to the high risk of pulmonary~     aspiration of the stomach contents. This is especially important in emergency procedures,~     when a fasting period is not observed. The aspiration of the stomach contents into one's~     lungs can lead to serious complications (such as severe respiratory failure). Information~     from a bedside ultrasound assessment of the stomach may be a very useful tool to decide~     whether or not it's safe to proceed, cancel or delay a surgical procedure.~   "
152976|NCT01564017|"~     As part of the registration plan of our products and after performing a Phase I study the~     present trial has been designed to compare the efficacy of 5 different doses of subcutaneous~     immunotherapy in depot presentation.~   "
152977|NCT01564004|"~     Does clinical hypnosis or neuro-linguistic programming improve the success rate of external~     cephalic version?~   "
152978|NCT01563991|"~     Subjects undergoing surgery on the small or large bowel will be randomized to one of 2~     groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact~     of this change on recovery after surgery.~   "
152979|NCT01563978|"~     The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on~     ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a~     disease-modifying anti-rheumatic drug (DMARD).~      The study will last for 57 days.~   "
152980|NCT01563965|"~     Prolonged pre-operative fasting increases postoperative hospital stay and current evidence~     recommends carbohydrate (CHO) drinks 2 hours before surgery. Our hypothesis is that the~     addition of hydrolized protein to a CHO-based drink not only reduces the inflammatory~     response but also diminish hospitalization.~   "
152981|NCT01563952|"~     Guidance of stenting by IVUS has been proposed as a method to reduce restenosis rates,~     because lumen and stent dimensions can be accurately determined by intravascular ultrasound~     (IVUS).~   "
152982|NCT01563939|"~     Epidural analgesia for pain relief in labor may not be suitable for all patients, and~     intravenous patient controlled analgesia (IV PCA) with opioids offers the best alternative.~     The purpose of this study is to assess the effectiveness of two methods remifentanil~     administration in the form of either an infusion or PCA demand bolus (intravenous injection~     of a single dose over a short period of time). Currently, our hospital gives remifentanil by~     demand bolus, however it may be equally effective, with less side effects, to give the drug~     as an infusion.~   "
152983|NCT01563926|"~     This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid~     somatropin formulation in children with growth hormone deficiency.~   "
152984|NCT01563913|"~     The purpose of this research study is to measure the safety (side effects) of an Omega 3~     Fatty acid called docosahexanoic acid (DHA) and measure the dyskinesia (involuntary~     movements) in Parkinson 's disease (PD).~   "
152985|NCT01563900|"~     Fatigue is a symptom present in 76 to 92% of people with multiple sclerosis (MS). Fatigue is~     usually described as an overwhelming sense of tiredness, lack of energy, and feeling of~     exhaustion which is different from sleepiness. Fatigue is also a symptom commonly seen in~     people with obstructive sleep apnea (OSA). The overall objective is to develop a~     non-pharmacological treatment for fatigue in MS. The objective of this study is to evaluate~     if treatment of OSA with continuous positive airway pressure (CPAP) improves fatigue in MS~     subjects with OSA and fatigue. This will be a small pilot randomized, double-blind,~     sham-controlled clinical trial; the control group will be treated with a sham-CPAP machine~     and intervention group will be treated with an auto-titration CPAP machine. The primary~     outcome measure will be improvement (decrease) in the Modified Fatigue Impact Scale from~     baseline. The duration of intervention will be 12 weeks to achieve a clinical response in the~     treatment group. After this intervention participants in both groups will be offered a~     referral to the sleep clinic of their preference for formal treatment as per standard of~     care.~   "
152986|NCT01563887|"~     This study will recruit drivers with Type 1 diabetes from across the U.S. and assign them to~     four groups based on their presumed risk level- routine care low risk, routine care high~     risk, or to one of two Internet interventions focused on reducing hypoglycemia driving. All~     subjects will be followed for two years to determine whether and which intervention was most~     effective at reducing hypoglycemia related driving collisions.~   "
153007|NCT01563601|"~     This is a randomized, multi-center, open-label study of approximately 24 months duration~     (including follow up survival) to evaluate the safety and efficacy of obatoclax mesylate in~     combination with carboplatin and etoposide versus carboplatin and etoposide alone in~     chemotherapy-naive patients with extensive-stage small cell lung cancer.~   "
153020|NCT01563419|"~     Insulin treatment is crucial for glucose control. Many patients with type 2 diabetes exhibit~     inadequate glycemic control in spite of combination of oral antidiabetic drugs and eventually~     need insulin therapy. Patients who need insulin therapy are older and have poor visual~     acuity, which predispose to inaccurate dosing and consequent hyper or hypoglycemia.In this~     study, the investigators examined the clinical usefulness of a magnifier for elderly diabetic~     patients who had used insulin pens.~   "
153142|NCT01561833|"~     This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell~     lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy~     (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other~     transformed T-cell lymphomas with the primary objective of studying the biological effects of~     the multikinase inhibitor, sorafenib.~   "
152987|NCT01563874|"~     BACKGROUND:~      Lymphomas are comprised of a diversity of tumors with different pathologic and clinical~     features. While distinct differences in gene expression profiles have been elucidated in~     different lymphomas, there has been inconsistent correlation with the few published proteomic~     studies.~      Greater insights into the biology of lymphomas may be achieved by integrating current genomic~     information with additional studies focused on the interrelationships in tumors of the~     patterns of chromatin protein expression, chromatin protein modification, and RNA expression~     profiling (both within bulk tumor and within specific microscopic tumor niches accessible by~     microdissection and cell sorting approaches).~      OBJECTIVES:~      The goals of this protocol are to identify the global levels of all histones (including~     variant histones) and non-histone chromosomal proteins, and to measure the relative levels of~     most known covalent modifications on histone and non-histone chromosomal proteins.~      For a limited number of cases illustrative of selected pathological entities, we propose to~     map the genome-wide distribution of those modifications judged to be biochemically~     instructive.~      ELIGIBILITY:~      This work will involve the analysis of a broad panel of lymphoma and lymphoid samples, which~     were previously procured under multiple protocols at the NIH, and for which there is excess~     tissue available for research. We also request permission to extend this analysis to surplus~     materials to be accrued under existing protocols, upon completion of all superseding~     diagnostic tests and medical/scientific studies. The criteria for inclusion in this study are~     subsumed under the enveloping protocols. The number of cases to be included is dependent upon~     the size of these protocols; because statistical significance improves with increasing~     numbers. We hope to include up to 300 cases.~      DESIGN:~      Lysates from surplus samples will be prepared and arrayed onto microarrays.~      These arrays will be probed with panels of protein and modification specific antibodies.~      The antibody reactivity will be quantified and samples will be subjected to statistical~     analysis, especially hierarchical clustering to correlate patterns of reactivity with~     clinical and histological features.~      Representative cases for which sufficient surplus tissue remains will be subjected to~     ChIP-Seq to map the distribution of modifications across the genome.~   "
152988|NCT01563861|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer. It may also help~     doctors find better ways to treat cancer.~      PURPOSE: This research trial studies genes in samples from patients with limited and advanced~     diffuse large B-cell lymphoma.~   "
152989|NCT01563848|"~     The investigators hypothesized that revealing the incidence of AF following RFA of the CTI~     and cryoablation PVI reduces incidence of AF following RFA of the CTI.~   "
152990|NCT01563835|"~     There has been very little investigation into the management of pain from 2nd trimester~     termination of pregnancy or unexpected fetal loss. The standard of practice in North America~     is usually intravenous patient controlled analgesia (IV PCA), using a narcotic wuch as~     fentanyl. The goal of this study is to compare the quality of recovery after termination of~     pregnancy using fentanyl IV PCA or patient controlled epidural analgesia (PCEA), a standard~     of care for live births. The study will be conducted as a randomized controlled trial.~   "
152991|NCT01563822|"~     Background:~      Traditionally during ovum pick-up in ICSI, we aspirate the follicles for oocyte retrieval but~     unfortunately we don't make use of the follicular fluid (FF) and we discard it in spite of~     the fact that this does not happen in nature. The fallopian tube picks-up the FF with the~     oocyte during ovulation. As this fluid contains stem cell factor and C-Kit receptor~     responsible for implantation and IGF responsible for endometrial growth and TGF that improves~     implantation. That's why flushing the endometrial cavity with FF after ovum pick-up might~     improve endometrial receptivity and implantation rates; the limiting step in ICSI.~      Patients and Methods:~      100 patients attending kasr El-Aini IVF center preparing for ICSI cycles are randomized into~     two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular~     fluid surrounding mature oocytes through an IUI catheter is done after ovum pick-up While in~     the control group, no flushing of the endometrial cavity with FF is done. The implantation~     rates and pregnancy rates in both groups will be assessed.~   "
152992|NCT01563809|"~     Basing the investigators study on the evidence that basal serum androgens decrease with age,~     the investigators hypothesize that women with serum androgens below a certain level could be~     the population obtaining a benefit of Luteinizing Hormone (LH) supplementation. The objective~     of the present study is to explore the relationship between basal serum androgen levels and~     the need of LH for Controlled Ovarian Stimulation (COS) in IVF.~   "
152993|NCT01563796|"~     The objective of this study is to use a DEK ELISA to quantitatively measure DEK protein in~     the urine of patients suspected of having bladder cancer. The measurement of urine DEK~     protein, relative to an established cut-off, is correlated with the presence or absence of~     bladder cancer.~   "
152994|NCT01563783|"~     This Post Market study is being conducted to compare the direct and indirect cost of three~     approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of~     symptomatic uterine fibroids.~   "
152995|NCT01563770|"~     Rationale: Extracts of the plant Salvia miltiorrhiza (Danshen) have been used as traditional~     Chinese medicine in the treatment of cardiovascular diseases, such as angina pectoris and~     myocardial infarction. Several preclinical studies point towards promising effects of Danshen~     on risk factors of atherosclerotic cardiovascular diseases, such as hyperlipidemia and~     hypertension.~      Objective: Our primary objective is to determine the effect of Salvia miltiorrhiza extract~     (Danshen) on hyperlipidemia. Secondary objective is to investigate the effect of Danshen on~     hypertension. Further objectives are to determine its effect on endothelial function,~     oxidative stress, inflammation, hemostasis and hemorheology, and on insulin sensitivity.~   "
152996|NCT01563757|"~     The investigators are studying what causes Plastic Bronchitis and Protein Losing Enteropathy.~     The investigators think that these problems are from too much of two small proteins called~     Vasoactive Intestinal Peptide (VIP) and Substance P. VIP and Substance P are important~     proteins in the body that normally tell the body to make small amounts of fluid and they help~     the intestines work. Normally, VIP and Substance P are made in the intestines and then~     destroyed in the lungs after they do their normal work. The investigators think that kids who~     have Plastic Bronchitis and/or Protein Losing Enteropathy who also had the Fontan surgery~     might have too much VIP and Substance P in their bodies. The investigators think this causes~     too much fluid to go in the lungs and too much protein in the intestines.~   "
152997|NCT01563744|"~     Adequate bowel preparation is of critical importance for colonoscopy. Particularly among~     hospitalized patients, inadequate bowel preparation for colonoscopy may arise due to patient~     intolerance to prescribed laxative regimen, elderly population, and co-existing conditions~     that impair the ability to ingest a large-volume laxative regimen. Improvements in bowel~     preparation for colonoscopy in hospitalized patients would likely improve patient care and~     reduce hospital costs. The purpose of this study is to determine if administering a portion~     of the bowel purgative via EGD could improve colonoscopy preparation in hospitalized~     patients.~   "
153229|NCT01560689|"~     The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective~     in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.~   "
152998|NCT01563731|"~     Stroke is one of the major causes not only of mortality, but of disease burden worldwide,~     because of residual disability and cognitive decline. Although blood pressure lowering has~     been clearly shown to be the most effective means for primary and secondary prevention of~     stroke, the systolic blood pressure (SBP) levels to achieve by treatment in order to optimize~     prevention results are unknown, and whether SBP levels lower than those usually recommended~     are accompanied by further or reduced benefits is undecided yet. Likewise, while low-density~     lipoprotein cholesterol (LDL-C) lowering by statins has been shown to be associated with~     primary and secondary stroke prevention, whether more intense lowering is or is not of~     further benefit is unknown. The Stroke in Hypertension Optimal Treatment Trial (ESH-CHL-SHOT)~     is a factorial 3 x 2 arm, multicenter, randomized clinical trial designed to test the~     hypothesis that in elderly patients at high risk of recurrent stroke (previous recent stroke~     or TIA) antihypertensive treatment programs aimed at reducing SBP to the usually recommended~     values (< 145 to 135 mmHg), to a lower goal (< 135 to 125 mmHg) or to even lower values (<~     125 mmHg) will result in progressively greater reductions in recurrent stroke, incidence of~     cardiovascular outcomes and cognitive decline. Parallely, the preventive efficacy of more and~     less intense LDL-C reductions will be tested on the same outcomes.~   "
152999|NCT01563718|"~     Naltrexone is a medication that has been shown to help prevent relapse to opioid addiction~     and it has been reported to be clinically effective in parolee populations although it is~     rarely used. Recently a depot formulation with one-month duration has received FDA approval~     for the treatment of alcoholism and opiate dependence. This means that rather than having to~     take medication daily, individuals can receive one injection that lasts for approximately 30~     days. The purpose of this study is to determine whether this monthly injection of naltrexone~     is practical and useful in the prevention of relapse to opioids and re-incarceration when~     administered to inmates prior to release from prison. The investigators will also monitor HIV~     risk behaviors to determine whether the intervention reduces risky behaviors associated with~     intravenous drug abuse and the spread of viruses such as HIV and hepatitis C. Volunteers will~     be randomized to receive an injection of depot naltrexone prior to release from prison or to~     contact study personnel in the community following release. Participants assigned to receive~     naltrexone in prison will receive 1 injection in prison, and 5 additional monthly injections~     for 5 months upon release. Participants assigned to contact study personnel upon release will~     receive all 6 injections in the community at RIH after their release from the ACI. Patients~     in both groups will be given identical follow up monthly for six months including measures of~     opiate use by self-report, and urine tests. An additional scheduled urine test will take~     place each month between monthly visits. There will also be a 12-month follow-up period for~     participants in both groups, which will consist of 2 visits, spaced 6 months apart, meaning~     that participants will be enrolled in the study for a total of about 18 months. All~     participants will be asked to complete brief questionnaires at follow-up visits to assess~     things such as services received, drug use, and depression.~   "
153000|NCT01563705|"~     The aim of this study is to improve knowledge of natural history and methods of monitoring~     the evolution of Glycogen storage disease type III regarding the muscle and to study the~     prospective approach of large series of patients, and using the same protocol for the follow~     up of the children and adults.~   "
153001|NCT01563692|"~     Respiratory Syncytial Virus (RSV) is a human restricted pathogen and is the single most~     important cause of severe respiratory illness in infants and young children, a major cause of~     infantile bronchiolitis and is the most frequent cause of hospitalization of infants and~     young children in industrialized countries. Severe RSV infection early in life is associated~     with an increased risk of subsequent recurrent wheezing and asthma. There are few~     population-based estimates of the incidence of RSV disease from developing countries, but the~     existing data clearly indicates that the virus accounts for a high proportion of Acute~     Respiratory Infections (ARI) in children. Studies in Brazil, Colombia and Thailand suggest~     that RSV causes 20-30% of ARI cases in children from 1-4 years of age, a proportion similar~     to that in industrialized countries, and WHO has estimated the global RSV disease burden at~     64 million cases and 160 000 deaths every year. RSV also causes severe disease in elderly and~     immune-compromised adults, and the burden of RSV disease in the elderly is comparable to that~     of seasonal influenza. The economic impact of RSV-related disease in adults estimated to be~     greater than that of influenza in relation to numbers of days lost from work.~      The development of a safe and effective vaccine against RSV would benefit greatly from data~     on the immune responses in healthy adults naturally exposed to the virus. RSV infection has~     been shown to increase and induce short-lived circulating antibody secreting cells and~     produce an increase in the RSV specific antibody titres but very limited data is available on~     the cellular immune responses induced by RSV during natural infection in healthy adults. The~     existence of cell mediated immune response against RSV in humans has been described but~     characterization of this response remains poor and simultaneous analysis of several~     immunological parameters have not been attempted in an RSV exposed population before.~   "
153002|NCT01563679|"~     This is a study involving patients with cancer who are referred by their treating physician~     for percutaneous locoregional therapies.~      Patient's clinical and radiology findings, pathology findings, survival, treatment responses,~     and complications after their locoregional therapy will be studied.~   "
153003|NCT01563653|"~     The investigators hypothesize that an innovative test device simulating transvaginal tape~     support will increase the performance and reproducibility of the diagnosis of urethral~     hypermobility before surgery for urinary incontinence.~      The main objective of this study is to compare two prognostic tests in their ability to~     predict the success (or failure) of the implementation of a suburethral TVT (tension-free~     vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in~     women. The Q-tip test (test mentioned in the French and international recommendations) is~     compared to test a new test (clip strip).~   "
153004|NCT01563640|"~     This is a randomised controlled trial that will be conducted in eastern Thailand in a group~     of schools with approximately 2,000 students aged 7-15 years. Pre-fabricated school uniforms~     will be commercially treated to ensure consistent high quality of insecticide impregnation~     with permethrin. A double-blind randomised cross-over trial at the school level will cover~     two dengue transmission seasons.~   "
153005|NCT01563627|"~     Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug~     resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies~     with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where~     feasible, surgical removal of the home is the best therapeutic outcome.~      Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical~     and experimental studies have shown that dysfunction of the blood-brain barrier (BBB)~     contributes to epileptogenesis and drug resistance. It is now recognized that cytokines~     exacerbate the excitability and permeability of the BBB, which was recently confirmed by~     studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have~     described an association between pathological angiogenesis and BBB permeability in the tissue~     of patients with excision of drug-resistant TLE. With experimental models, it was revealed an~     activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB.~      The investigators hypothesis is that the identification of factors involved in BBB~     permeability may designate potential targets for drug-resistant partial epilepsy.~   "
153006|NCT01563614|"~     The purpose of this trial is to test the safety and tolerance of the combination therapy with~     cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from~     malignant melanoma.~   "
153008|NCT01563588|"~     Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them~     are able to find back to their initial weight after all treatments are finished. Other~     studies have shown that overweight at diagnosis was associated to a twice higher risk of~     relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In~     western countries, 75% of BCP have insufficient physical activity. Dietary and activity~     programs seem to be able to significantly reduce the mortality risk after breast cancer.~      The investigators performed a prospective randomized trial consisting in dietary counseling,~     physical training and physiotherapy in hydrothermal centers. Intervention were delivered in~     small group session lasting 12 days. SPA cares were offered to patients. Patients in the~     control group also received dietary counseling given by a dietetician inside anticancer~     hospital, and were asked to perform more physical activities. Main endpoints of the trial~     addressed quality of life (SF36) one year after inclusion, weight reduction,~     anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic~     study was associated to the protocol, for volunteers only.~   "
153009|NCT01563575|"~     The project's background is the notion that patient centred clinical health promotion has~     been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO~     describes health promotion as a key dimension of quality in hospitals, and the organization~     has developed standards on the topic in order to help hospital management and staff members~     to assess and improve the quality of health care and thereby achieve better health for~     patients, staff, and community. Even so, however, health promotion is still a very implicit~     part of nearly all quality standards on hospitals. Moreover, assessing hospitals departments'~     health promotion performance is still quite an unexplored area. On this basis, this project~     will test a new recognition process that uses the relevant WHO-HPH tools and standards to~     assess performance, by way of explicit documentation and evaluation of clinical health~     promotion activity. The project is deigned as a RCT, with a control group that undergoes the~     recognition process immediately and a control group that continue usual clinical routine.~     Then, after one year, the control group also begins the recognition process (= delayed~     start), while the Intervention group (=immediate-start) continues with the recognition~     process. Doing this allows for a great array of measurements, and hopefully the project will~     then show whether the recognition process really benefits implementation of health promotion~     in hospitals and health services, and also, if this really generates better health gains for~     patients and staff. The outcome measurements will be frequency of health promotion services~     delivered on smoking, excessive alcohol use, overweight, malnutrition, and physical activity~     to patients in need. Such services could for instance be motivational counselling and brief~     interventions, as well as intervention, rehabilitation and after treatment. Physical, mental,~     and social health status among patients and staff will be measured by short form (SF36).~   "
153010|NCT01563562|"~     The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl~     following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and~     severe hepatic impairment, as compared to healthy volunteers.~   "
153011|NCT01563536|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and~     antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir)~     administered as two-day monotherapy followed by ABT-267 in combination therapy with other~     direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also~     known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV)~     infection without cirrhosis.~   "
153012|NCT01563523|"~     This trial is conducted in Africa, Asia, Europe, Oceania and North America. The aim of this~     trial is to evaluate the efficacy of activated recombinant human factor VII given in~     conjunction with standard therapy in the treatment of massive bleeding in subjects with~     severe blunt and/or penetrating trauma injury.~   "
153013|NCT01563510|"~     The purpose of this research is to investigate the key technology and the related issues of~     minimal invasive treatment for hepatolithiasis and to build new methods of minimal invasive~     operation for hepatolithiasis. The validity, feasibility and limitations of the laparoscopic~     operation were assessed objectively through our clinical prospective study. The technique~     points, indications and contraindications were summarized to evaluate the status and role of~     minimal invasive laparoscopic operation in the treatment of hepatolithiasis.~   "
153014|NCT01563497|"~     The primary purpose of this study is to estimate the relative bioavailability and food effect~     of a PF-05089771 tablet.~   "
153015|NCT01563484|"~     Primary Hepatocellular Carcinoma (PHC) is one of the most common malignant tumors in the~     world. In men is the fifth most frequently diagnosed cancer worldwide but the second most~     frequent cause of cancer death. In women, it is the seventh most commonly diagnosed cancer~     and the sixth leading cause of cancer death. An estimated 748,300 new liver cancer cases and~     695,900 cancer deaths occurred worldwide in 2008. Half of these cases and deaths were~     estimated to occur in China. Surgical resection and liver transplantation can be curative~     treatment options, but less than 20% of PHC patients are candidates for surgery. The~     prognosis of patients with unresectable PHC is poor; if left untreated, the median survival~     is less than 6 months. Since transarterial chemoembolization (TACE) was introduced as a~     palliative treatment in patients with unresectable HCC, it has become one of the most common~     forms of interventional therapy. However, the possibility of treatment-related complication~     may offset the survival benefit, especially by the worsening of liver functions.TACE~     increases several parameters of hepatic cytolysis and decreases the metabolic activity of the~     liver. Such a deterioration of liver function due to ischemia following TACE may result in~     liver failure, or even death. TACE also may have an adverse effect on the kidney.~     Radiographic contrast medium is used to obtain the hepatogram before TACE. It has been shown~     that the use of contrast medium increases the risk of renal failure, especially the~     low-osmolar contrast media. The aim of this trials was to compare the change of liver and~     renal function after TACE for HCC of iso-osmolar contrast media with that of low-osmolar~     contrast media.~   "
153016|NCT01563471|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics of three different single doses activated recombinant human factor VII in~     Caucasian and Japanese healthy subjects.~   "
153017|NCT01563458|"~     This trial is conducted in Europe, North America and Oceania. The aim of this trial is to~     evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects~     undergoing orthotopic liver transplantation surgery.~   "
153018|NCT01563445|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the safety and preliminary efficacy of activated recombinant human factor VII~     (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).~   "
153019|NCT01563432|"~     This study was designed to compare and evaluate the pharmacokinetic characteristics of~     febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in~     healthy adults; and to evaluate safety and tolerance following a single-dose administration.~   "
153021|NCT01563406|"~     Central venous catheter infections are common preventable adverse events among hospital~     patients. Microbes may enter catheter hubs, also known as needleless connectors, and result~     in downstream contamination. This study aims to compare alcohol disinfection of catheter hubs~     to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a~     superior disinfectant at the site of central venous catheter insertion. Scrub duration of~     central venous catheter hubs will also be evaluated.~   "
153022|NCT01563393|"~     Children hospitalized due to an acute disease may suffer from acute malnutrition or chronic~     malnutrition caused by chronic diseases. According to various studies, about 10-20% of those~     admitted to hospitals in different countries suffer from malnutrition or are at risk of~     malnutrition.~      Several pediatric nutritional screening tools were recently published. However, there is no~     conventional pediatric nutritional screening tool and the effect of the recently published~     tools on further nutritional risk and the behavior of the attending staff are unclear.~      Study objectives: to test the validity and reliability of the STAMP nutritional screening~     tool (Screening Tool for the Assessment of Malnutrition in Pediatrics) among children~     hospitalized in a pediatric medical center and to examine the effect of the STAMP tool use on~     the attitude of the medical staff to the patient nutritional status.~      An additional objective is to compare the skill of a nurse versus a dietician in performing~     the evaluation according to STAMP.~      Methods: for the validation, 50 children between 1 and 17 years of age from internal medicine~     and surgical departments will undergo a complete evaluation by an investigating dietician and~     assessment by the STAMP tool in order to determine the extent of the nutritional risk on a~     numerical scale. All the children will undergo STAMP evaluation by a nurse and another~     investigating dietician as well.~      In order to examine the effect of the tool on the medical staff awareness, 300 files of~     hospitalized children will be tested: 150 files at the beginning of the study and prior to~     using the tool and 150 after 6 months at the same ages and in the same departments.~      The effect of using the STAMP questionnaire will be examined according to the results of data~     collection from the beginning of the study and after 6 months. Questionnaire use, recording~     of appropriate diagnoses, collection of blood tests demonstrating the nutritional status,~     weight, height and waist circumference measurements will be obtained from the patients'~     medical files.~   "
153023|NCT01563380|"~     This study was designed to evaluate the efficacy of leucocyte free autologous platelet rich~     plasma on blood loss, pain, wound healing and functional outcome after total knee~     arthroplasty. The investigators hypothesized that application of platelet rich plasma would~     help in reducing blood loss, postoperative pain and expedite wound healing and better~     short-term functional outcome following total knee arthroplasty.~   "
153024|NCT01563367|"~     The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®)~     is superior compared to placebo with respect to increasing the haemoglobin level in~     non-anaemic patients undergoing cardiac surgery~   "
153025|NCT01563354|"~     This is a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a~     single-stage design in each arm. The purpose of this study is to test the effectiveness and~     safety of Everolimus or Pasireotide LAR alone or in combination in adult patients with~     advanced (unresectable or metastatic) neuroendocrine carcinoma (typical and atypical) of the~     lung and thymus. It is expected that a total of 120 patients with 40 patients in each arm~     will be enrolled into this study. Patients with disease control (SD or better) in the~     combination arm or monotherapy with pasireotide LAR and everolimus and who are not~     experiencing unacceptable toxicity are permitted to continue treatment after the 12 month~     treatment period in the extension phase of the study. Primary Endpoint is defined as the~     proportion of patients who are progression-free at 9 months according to RECIST V 1.1~   "
153026|NCT01563341|"~     Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus~     potentially improve cognitive function in patients with Parkinsons disease.~   "
153027|NCT01563328|"~     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3~     clinical development for the treatment of human immunodeficiency virus (HIV) infection.~     Co-infection with Hepatitis C (HCV) is common in HIV-infected subjects therefore it is~     expected that DTG will be coadministered with treatments for HCV. Boceprevir (BCV) and~     Telaprevir (TVR) are protease inhibitors for the treatment of HCV that were recently approved~     by the Food and Drug Administration/European Medicines Agency (FDA/EMA) and have rapidly been~     adopted to standard of care in combination with pegylated interferon and ribavarin. This is~     a single-center, open-label, two-cohort, two-period, one-way, study in healthy adult~     subjects. A total of approximately 32 subjects will be enrolled, in order to obtain 24~     evaluable subjects (12 per cohort). In the first treatment period, all subjects will receive~     DTG 50 mg once daily for 5 days (treatment A). In period 2, subjects will receive DTG 50 mg~     once daily plus either BCV 800 mg q8h (treatment B) for 10 days or TVR 750 mg q8h (treatment~     C) for 10 days. There will be no washout between treatments. Safety evaluations and serial PK~     samples will be collected during each treatment period.~      Subjects will have a screening visit within 30 days prior to the first dose of study drug,~     two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug.~      This study will be conducted at one center in the US, with healthy adult male and female~     subjects.~   "
153028|NCT01563315|"~     The purpose of this study is to determine the etiology of community-acquired pneumonia, to~     assess risk factors and to investigate potential prognostic biomarkers of serious disease and~     fatal outcome.~   "
153029|NCT01563302|"~     This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of~     patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will~     be enrolled into the dose-expansion cohort.~   "
153030|NCT01563289|"~     The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients~     with ankle injuries.~   "
153042|NCT01563133|"~     This study focuses on three different lesions: pancreatic cysts, lymph nodes near the~     gastrointestinal tract and pancreatic masses.~      On one hand, the results obtained during previous studies are more advanced for the~     assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser~     Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have~     already been performed, and an interpretation criteria classification exists. On the other~     hand, results for pancreatic masses and Lymph nodes are less developed.~      The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on~     pancreatic masses and lymph nodes.~        1. Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and~          tissue sampling allows better characterization of pancreatic cysts and improves~          appropriate therapeutic decision-making.~           For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could~          impact patient management by :~             -  Ruling out malignancy for patients with benign appearing nCLE images.~             -  Characterizing more malignant tumors in the pancreas.~        2. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo~          imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during~          EUS-FNA procedures is feasible and that descriptive criteria can be defined to further~          differentiate the different types of lesions.~   "
153031|NCT01563276|"~     The purpose of this study is to better understand why individuals with Progressive~     Supranuclear Palsy (PSP) fall. Understanding the mechanism of gait and balance dysfunction in~     individuals with PSP may provide us with important early diagnostic tools, allowing for~     earlier identification of mobility problems and to better evaluate medical therapies aimed at~     improving motor disability.~      The investigators will recruit 10 PSP, 10 PD and 10 healthy controls for the study. All~     subjects will be asked to come to the OHSU clinic at the Center for Health and Healing for an~     initial screening visit. They will meet with the primary investigator to conduct a brief~     interview and physical examination. In addition, they will be asked to answer questions~     regarding current and past medical illness, how often they fall and what kinds of medications~     they are on.~      Subjects who agree to participate will come to the Oregon Clinical and Translational Research~     Institute (OCTRI) at OHSU for balance testing. Subjects will be asked to stand or sit on a~     movable platform with eyes open or closed. Prior to standing on the platform, the~     investigators will place 6 small sensors on body which are held in place by velcro straps~     (one on each wrist, ankles, chest and lower back). The platform will then be moved (tilt or~     slide) while subjects try to keep their balance. During all of the balance tests described~     above, body movements will be recorded from the sensors on the subjects' body. This data is~     directly recorded by a computer and analyzed to help us gain better understanding of the~     subjects' posture and their ability to remain up right.~   "
153032|NCT01563263|"~     This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase~     II/III study. The study population consists of male or female intensive care unit (ICU)~     patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and~     80 years.~   "
153033|NCT01563250|"~     By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the~     investigators can effectively reduce ED wait times and ED length of stay by decreasing~     overall hospital admissions and telemetry admissions. In addition, the investigators~     hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by~     increasing the patient to health care provider ratio.~   "
153034|NCT01563237|"~     To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma~     that is inadequately controlled on maximum tolerated medical therapy with intraocular~     pressure ≥ 18 mm Hg and ≤ 40 mm Hg~   "
153035|NCT01563224|"~     There are several developing lines of evidence suggesting that brain receptors called GABA-B~     receptors play a significant role in addiction and its treatment. The investigators wish to~     examine the sensitivity of brain GABA-B receptors in alcohol and opiate addicts as part of~     the investigators MRC programme of research in neurotransmitters in alcohol and opiate~     addiction (NOAA). In this present study the investigators will give 2 different single doses~     of a drug called baclofen, and a placebo, to 8 healthy male volunteers. This drug affects~     GABA-B receptors in the central nervous system and is licensed for the treatment of~     spasticity in people with eg spinal injuries; the investigators are interested in its effects~     on brain GABA-B receptors. The investigators will measure EEG (brainwaves), eye movements,~     blood pressure and heart rate, motor co-ordination and subjective effects and also blood~     levels of the drug in the investigators volunteers before and at intervals after dosing. The~     investigators will use a double-blind randomised design to minimise expectation effects. The~     study will provide information on timing and magnitude of effects of baclofen on brain~     function in healthy subjects so that the investigators can optimise selection and timing of~     functional measures in future studies of addicts.~   "
153036|NCT01563211|"~     Patients with breast cancer, who are treated with curative intent, have a combination of~     surgery (excision of the tumor) and a course of medical therapy (chemotherapy or endocrine~     treatment). Both treatments are associated with significant side effects. Chemotherapy is~     associated with nausea, vomiting, hair loss and bone marrow suppression, whereas endocrine~     therapy is associated with arthritis and menopausal symptoms. Patients taking either~     chemotherapy or endocrine treatment may experience a range of side effects. The range and~     severity of side effects experienced vary from patient to patient. Little or nothing is known~     about the reason for this difference.~      The aim of the investigators proposal is to develop a pretreatment test to identify patients~     who are likely to undergo moderate to severe side effects, and therefore help doctors and~     patients plan and optimize medical therapy. The pretreatment test will be based on~     identifying a metabolic profile which can differentiate those patients who are likely to have~     severe or moderate side effects from those with either no or mild side effects. To do this,~     the investigators will take urine and blood samples from patients before and after the~     administration of endocrine treatment or chemotherapy and generate metabolic profiles.~      Furthermore, the investigators aim to gain an understanding into why side effects experienced~     between different patients are so variable. To do this the investigators plan to perform~     cytokine analysis, targeted genetic analysis and pharmaokinetic analysis on blood sample~     collected from patients before and after treatment has commenced. Patients who have planned~     surgical excision of tumor and are recommended to receive medical therapy before or after~     surgery would be invited to join the study. Each patient will be required to make additional~     visits to the hospital to complete questionnaires regarding side effects experienced and for~     sample (urine and blood) collection. The investigators plan to recruit 168 patients.~   "
153037|NCT01563198|"~     Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of~     claustrophobia or inability to hold still. Training staff working in MRI facilities to~     provide Comfort Talk® promises to enable patients to complete and obtain high quality imaging~     without medication, which will increase comfort and reduce sedation risks for the patients,~     and increase efficiency and reduce loss of revenue for the facilities.~   "
153038|NCT01563185|"~     The primary objective of this Phase 4, multi-center, open-label study is to evaluate the~     safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10~     years to 16 years, 11 months, treated up to 24 weeks.~      The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and~     to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months~     receiving DUEXIS for up to 24 weeks.~   "
153039|NCT01563172|"~     This study will evaluate and compare the effect of the amount of toothpaste used and brushing~     time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel~     fluoride uptake (EFU).~   "
153040|NCT01563159|"~     This study aims to confirm the statistically significant decline in rotavirus related and in~     acute gastro-enteritis (AGE) related hospital admissions that was observed in 11~     participating hospitals, after the introduction of RV vaccines in Belgium in 2006.~   "
153041|NCT01563146|"~     This study aims to collect data and assess the number of rotavirus related hospitalizations~     in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis~     over time.~   "
153124|NCT01562067|"~     Cervical tumors are characterized by vascular changes (in terms of quantity, volume and~     Flows) in the tumor. Due to a good access to the cervix through the vagina, these parameters~     can be assessed using a three dimensional supersonic. Sonographic characteristics of tumor~     indices measures before and after oncological treatments may shed light on the patient's~     prognosis.~   "
153043|NCT01563120|"~     Rationale Gestational diabetes mellitus (GDM) complicates 5-7% of pregnancies. Major hazards~     include macrosomia, polyhydramnios, labor trauma and neonatal hypoglycemia. The ADA and ACOG~     recommend glucose control in order to reduce the incidence of hyperglycemia induced~     complications. Glucose control can be achieved using diet and life style changes. Insulin is~     initiated in women who fail to obtain glucose control with diet alone. During the past 11~     years oral hypoglycemic drugs have been tested and proven to be efficacious and safe.~      Objectives~        1. To compare the efficacy and safety of glybenclamide vs. metformin in the treatment of~          women diagnosed with GDM~        2. To evaluate the improvement in glycemic control after the addition of a second oral~          hypoglycemic drug after failure of the first~      Hypothesis GDM is one of the major conditions contributing to obstetrical complications and~     prenatal morbidity. Improving glycemic control, by means of improving compliance and patient~     satisfaction, will decrease obstetrical complications, maternal and neonatal morbidity and~     have positive long term health implications.~      Study design Prospective, randomized, open label~      Study population Women between the ages 18-45, diagnosed with GDM will be recruited. GDM will~     be defined by a pathological OGTT (according to Carpenter and Coustan criteria) performed at~     or after 13 weeks of gestation.~      Study period From recruitment until discharge of the newborn baby after delivery~      Study protocol Women will be randomized at recruitment. Demographic and obstetrical data will~     be collected. Average glucose levels during the previous two weeks, estimated fetal weight~     and amniotic fluid index, and lab exams reflecting glycemic control will be noted. Women will~     provide daily glucose levels via fax or mail once a week. Glycemic control will be evaluated~     by a daily chart, including 7 measurements: 3 preprandial, 3 postprandial and a 7th~     measurement at 10 pm. Women will be invited to a monthly follow-up, which will include a~     sonographic evaluation of fetal weight and amniotic fluid, and lab exams. Follow-up protocol~     after 38 w of gestation will be according to our ward's protocol. The study was approved by~     the local Helsinki committee.~      Time table Duration: two years~   "
153044|NCT01563107|"~     Patients with Postural Tachycardia Syndrome (POTS) may not adequately expand their plasma~     volume in response to a high sodium diet. Mechanisms involved in the regulation of plasma~     volume, such as the renin-angiotensin-aldosterone system and renal dopamine (DA), may be~     impaired in POTS and may respond inappropriately to changes in dietary sodium. The~     investigators propose that the changes in urinary sodium and dopamine excretion caused by~     consuming low-sodium and high-sodium diets will be different between patients with POTS and~     healthy volunteers. The purpose of this study is to determine (1) whether changes in dietary~     sodium level appropriately influence sodium excretion in POTS; (2) whether changes in dietary~     sodium level appropriately influence DA excretion in POTS; (3) whether a high dietary sodium~     level appropriately expands plasma volume in POTS; and (4) whether patients with POTS have~     improvements in their orthostatic tachycardia and symptoms as a result of a high dietary~     sodium level.~   "
153045|NCT01563094|"~     This is a prospective observational trial of healthy postpartum women to investigate changes~     in bone density and markers of bone turnover during lactation. The study hypothesis is that~     women who breast-feed 5 months or more will lose bone density and subsequently regain the~     bone density after weaning. This study seeks to define determinants of the regain in bone~     density.~   "
153046|NCT01563081|"~     To evaluate the safety of treatment with levocetirizine oral solution in pediatric patients~     aged form 6 months to 2 years old with allergic rhinitis or pruritus associated with the skin~     diseases.~   "
153047|NCT01563068|"~     Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects~     with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for~     the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a~     multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their~     primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas~     of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14~     days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of~     calcipotriene will be evaluated~   "
153048|NCT01563055|"~     This is an open-label study to evaluate tolerability, safety, efficacy and pharmacokinetic~     profile of ofatumumab in combination with chlorambucil in Japanese patients with previously~     untreated Chronic Lymphocytic Leukemia (CLL).~   "
153049|NCT01563042|"~     An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics,~     immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in~     healthy male subjects~   "
153050|NCT01563029|"~     This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy,~     parallel-group, placebo and active controlled study in children aged 5-11 years with~     persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of~     the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period~     during which time they will continue their current medications. Visit 2 will occur two weeks~     into the run-in period to allow a review of compliance with daily diary and run-in~     medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility~     criteria who remain uncontrolled despite baseline therapy will be stratified based on pre~     screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to~     the treatment phase of the study where they will receive one of five treatments for 12 weeks.~     Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of~     115 randomized/evaluable subjects per treatment arm. Subjects will attend on-treatment visits~     at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up contact will be~     performed one week after completing study medication. All subjects must attempt spirometry~     measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine collection for~     urinary cortisol and creatinine excretion will be performed prior to randomization at Visit 2~     and within 7 days prior to Visit 7. All subjects must perform PEF daily between visits 1 and~     7. The primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) PM PEF~     from patient hand held electronic daily diary at Endpoint (Endpoint is defined as the mean~     over the last 7 days of treatment). Safety assessments include adverse events, oropharyngeal~     examinations, clinical chemistry, urinary cortisol, and vital signs.~   "
153051|NCT01563016|"~     The research aims to investigate the relationship between self-control ability and blood~     glucose level in schizophrenic patients. The main purpose of the present study is to explore~     whether the close relationship of blood glucose and self-regulatory strength observed in~     healthy individuals, is applicable to schizophrenic patients. More specifically, the current~     study aims~        -  to investigate whether the exertion of self-control reduces blood glucose,~        -  to examine whether low level of blood glucose deteriorates subsequent self-control~          performances~        -  to examine whether restoring the glucose level eliminates these impairments, in~          schizophrenic patients.~   "
153052|NCT01563003|"~     Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this~     study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in~     50 adolescents versus other available treatment options.~   "
153053|NCT01562990|"~     The purpose of this study is to determine the recommended dose of CMC544 administered in~     combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and~     oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of~     this combination will be evaluated preliminarily in patients with DLBCL in relapse or~     refractory, who are no candidates for autologous transplant.~   "
153054|NCT01562977|"~     The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and~     dexametasone (R-GemOx) chemotherapy schedule.~   "
153125|NCT01562054|"~     The operating room, OR, is a high-tech and complex domain in which clinicians' possession of~     clinical knowledge and good technical skills are essential, but not sufficient. Retrospective~     studies have shown that a large proportion of the mistakes that occur during surgery are not~     caused by lack of clinical skills but rather by insufficient communication and teamwork.~     Prospective studies have shown that insufficient teamwork in the OR causes a higher risk of~     complications and that communication failure in the surgical team causes procedural errors~     and delays. It is therefore evident, that surgeons and the surgical teams need skills in~     communication, teamwork, decision making and leadership (so called non-technical skills) to~     ensure a good outcome for surgical patients.~      Internationally different behavioural marker systems have been developed to aid training and~     assessment of non-technical skills such as Non-Technical Skills for Surgeons (NOTSS) from~     Scotland (12). In Denmark certain aspects of non-technical skills appear in the curricula for~     surgical trainees, but no formal training or assessment occurs at this point.~      The investigators developed a behavioural marker system for general surgeons adapted to the~     Danish cultural and organisational context (NOTSSdk). The behavioural marker system consists~     of four categories: leadership, situation awareness, decision making and communication &~     teamwork. Each category has between 3 and 4 elements underpinning it and each element has~     several behavioural examples illustrating good and poor behaviour.~      The system needs evaluation to ensure that it is valid and can be used reliably to observe~     and rate surgeons' intra operative performance.~      Aim: The aim of this study is to examine the psychometric properties of NOTSSdk in relation~     to it's construct validity, reliability, and usability in a simulated setting.~      Research questions:~        -  What is the inter rater reliability among raters?~        -  Are these ratings consistent with expert ratings (= gold standard ratings)?~        -  Can a one day training session improve novice raters' agreements (construct validity)?~      METHODS The study is designed to explore the reliability of the ratings made by surgeons as~     well as to examine whether the reliability improves with training. The study setting will be~     a one day course in which surgeons are asked to rate the non-technical performance of~     surgeons in simulated video scenarios. Two distinct sets of ratings will be obtained. The~     first at the beginning of the day when the surgeons have had no prior training in or~     knowledge of rating non-technical skills and at the end of the day after 5 hours of training.~      Sample A sample of general surgeons from all hospitals in Zeeland, Denmark will be recruited~     to participate as raters after the heads of the departments have been contacted and informed~     about the project. The investigators wish to recruit consultant surgeons (n=10) and senior~     residents in surgery (n=10) who have an interest in education and supervision. Once recruited~     background information such as age, gender, position, years of surgical experience and prior~     experience with assessment of others will be collected.~      Training and rating session The surgeons will attend a one day course. The course will~     consist of three parts: first a rating session to get baseline-ratings from participants of 6~     video scenarios, then a teaching and training session and then another rating session with 4~     new and 2 of the baseline-videos. During the first rating session the surgeons will only have~     the NOTSSdk rating form and will not be allowed to discuss with each other. The second rating~     session will be like the first but in addition to the rating form the participants will also~     be allowed to look in the full NOTSSdk behavioral marker system. The teaching will include an~     introduction to Human Factors and non-technical skills in surgery, and a short description of~     the development and intended use of NOTSSdk. The following training will allow participants~     to practice the rating of surgeons' non-technical skills on 4 video recorded scenarios and~     then discuss their ratings.~      Ratings of the lead surgeons' performance will be obtained at the category level of each~     scenario.~      Video recordings 14 simulated video recordings will be made showing general surgeons acting~     in their own roles during surgery. The scenarios will be scripted to display various~     scenarios of routine (such as unnoticed prolongation of a laparoscopic appendectomy) and~     non-routine situations (such as unexpected bleeding during open surgery). The scenarios will~     be designed after a specific structure aiming at a specific variation in the surgeons'~     non-technical performance according to the four categories of NOTSSdk.~   "
153055|NCT01562964|"~     This study will investigate whether clinical hypnotherapy can effectively treat chest pain~     symptoms, improve emotional wellbeing and quality of life in postmenopausal women with chest~     pain and coronary arteries without any narrowings. The diagnosis of chest pain with 'normal'~     coronary arteries is found in 25% of patients undergoing investigation of chest pain using~     coronary angiography (when dye is injected into the coronary arteries whilst xray pictures~     are taken), and the majority of these patients are postmenopausal women. Often there is no~     obvious physical cause. Despite symptoms being treated using conventional drugs, and life~     expectancy is not affected, many patients continue to suffer from debilitating chest pain~     symptoms, frequently resulting in visits to hospital, increased psychological illness and~     poor quality of life. The investigators are interested in finding ways of improving not only~     chest pain symptoms but also psychological wellbeing and quality of life in these patients.~     Previous studies of ours have found improvement in these patients after taking part in a~     support group, and using a relaxation technique called Autogenic training. Recently the~     investigators conducted a pilot study which showed a favourable effect of hypnotherapy on~     physical ability, well-being and quality of life. The investigators would now like to extend~     this study, performing a larger randomised, controlled trial. The investigators hypothesise~     that hypnotherapy will beneficially affect symptoms and quality of life in patients with~     cardiac Syndrome X.~   "
153056|NCT01562951|"~     This study will test that individualized treatment in patients with Crohn's Disease in~     remission or mild clinical activity under immunosuppressants may improve prognosis, rather~     than just treating flares.~   "
153057|NCT01562938|"~     This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects~     (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or~     placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed~     for safety from the time of Informed Consent through 360 days post dose.~   "
153058|NCT01562925|"~     Patients with impaired renal function are at elevated risk for development of contrast-medium~     induced acute kidney injury (CI-AKI). CI-AKI is associated with increased risk for~     cardiovascular morbidity and mortality. Effective CI-AKI prevention strategies are needed.~      The RenPro-II-WINE Trial was designed to test the hypothesis whether moderate red wine~     consumption prior to contrast-medium use is effective in CI-AKI prevention.~      Consecutive patients with impaired renal function undergoing elective coronary angiography~     will be assigned in one of four treatment arms: a. control patients receiving standard care~     b. patients receiving standard care plus red wine c. patients receiving standard care plus~     white wine d. patients receiving standard care plus beer This study will give important~     answers on how to prevent CI-AKI in patients with impaired renal function undergoing contrast~     media exposure.~   "
153059|NCT01562912|"~     Atrial fibrillation (AF) is the most common arrhythmia affecting the Canadian population. AF~     is associated with increased risk of stroke,HF, and even mortality. AF can cause debilitating~     symptoms, adversely affect patient's (pt's) quality of life and functional status. Hence a~     strategy of sinus rhythm (SR) may be pursued over a strategy of allowing AF to persist.~     Percutaneous catheter ablation is an effective alternative to antiarrhythmic drugs (AAD) for~     maintaining SR. The success rate of PV isolation off AAD is about 80-90% in pt's with PAF,~     but repeat procedures are required in up to 40% of pt's. After one ablation, the success rate~     may only be 50-70% off drugs.Current standard ablation procedures for PV antral isolation~     employ mapping systems which reconstructions of the LA and PV anatomy are created.~     Visualization may be supplemented by integration of CT/ MRI images and/or intracardiac~     echocardiography. Robotic navigation has been employed to assist in ablation. Based on single~     point unipolar radiofrequency (RF) ablation catheter where lesions are created point-by-point~     around the PVs to obtain electrical isolation.This results in lengthy complex, costly~     procedures,often more than 4 hours, which requires high degree of operator skill.Creation of~     contiguous, transmural lesions is challenging with standard single-point RF. A novel~     multipolar catheter ablation system has been evaluated for achieving PV isolation (PVAC~     catheter, Medtronic Inc.) An over-the-wire circular mapping/ablation catheter can be advanced~     into the PV antrum, and multiple lesions around the circumference of the catheter can be~     delivered simultaneously using duty-cycled unipolar and bipolar RF energy. Early reports, the~     system can achieve complete PV isolation with reduced fluoroscopy and procedural times using~     lower powers to achieve more reliable lesion sets.Long-term efficacy also seems comparable to~     standard RF ablation.This novel technology has potential to broaden the application of AF~     ablation, making procedures less time-consuming, less complex without compromising procedural~     efficacy. Published data PVAC technology outcomes are limited to studies with small sample~     sizes of 12-102 pt's. Data has been restricted to a small number of European centers~     performing moderate numbers of PVAC procedures. There is no prospective, multicenter data.~     Little is known about the efficiency of PVAC procedures, allowing for an assessment of~     cost-effectiveness in using this technology.~   "
153060|NCT01562899|"~     This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is~     to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the~     combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the~     clinical efficacy and to further assess the safety of the combination in selected patient~     populations. The dose escalation part of the study will be guided by a Bayesian Logistic~     Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose~     escalation part.~      Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess~     efficacy of the combination as well as to better understand the safety, tolerability, PK,~     antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of~     approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will~     consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm~     3 will consist of approximately 28 patients with mutant BRAFV600 melanoma.~      Patients will be treated until progression of disease, unacceptable toxicity develops, or~     withdrawal of informed consent, whichever occurs first. All patients will be followed up - at~     minimum patients must complete the safety follow-up assessments 30 days after the last dose~     of the study treatment.~   "
153061|NCT01562886|"~     This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral~     therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of~     the study the participants will attend clinic where they will have blood collected followed~     by a lumbar puncture where cerebrospinal fluid will be collected to measure drug~     concentration. The participants will then restart their original regime with nevirapine.~   "
153062|NCT01562873|"~     Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is~     thought that this pathway might be important in certain types of breast cancer, and that~     blocking this pathway might lead to anti-cancer effects. This study is testing the effects of~     ruxolitinib in patients with breast cancer.~   "
153126|NCT01562041|"~     The study is designed to evaluate the use of ETT ECG indices as biomarkers in the assessment~     of atherosclerotic coronary vascular disease (ASCVD).~   "
153063|NCT01562860|"~     The investigators are comparing two standard of care procedures which can be performed at the~     same time, or sequentially. The hypothesis being tested is whether simultaneous release of~     both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom~     relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal~     tunnel and pronator Teres syndromes are present.~   "
153064|NCT01562847|"~     The purposes of this study are to investigate expression and frequency of ABL point~     mutations, a major cause of resistance in imatinib failed CML Asian patients and to find~     causes of Asian-specific resistance to cancer-targeting therapies through a prospective~     investigation of dynamics of point mutations and expression of new point mutations during~     nilotinib treatment.~   "
153065|NCT01562834|"~     This trial is conducted in Europe. The aim of this trial is to assess the effect of~     somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients~     with a growth hormone deficiency.~   "
153066|NCT01562821|"~     This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic~     efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo~     partial hepatectomy due to liver cancer or benign tumours.~   "
153067|NCT01562808|"~     Dopamine receptor occupancy and brain metabolism were measured using positron emission~     tomography after the administration of aripiprazole. Working memory performance was also~     measured using N-back task.~      The investigators explored the relationship between changes in brain metabolism and working~     memory performance.~   "
153068|NCT01562795|"~     This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have~     therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two~     nonsteroid anti-inflammatory drops with topical corticosteroids.~   "
153069|NCT01562782|"~     The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in~     response to the ingestion of a mixture of glucose and fructose is greater in South Asians~     compared to controls (Caucasians).~   "
153070|NCT01562769|"~     Application of isolation (=contact precautions) in hospitalized patients is recommended when~     patient is colonized (or infected) by micro-organism known for its outbreak capacity or high~     pathogenicity. It allows the reinforcement of universal precautions (=standard precautions)~     in order to control patient-to-patient micro-organisms transmission. Recently, the efficacy~     of this measure is questioned and its impact on patient care seems deleterious.~      In a particular context of Infectious Disease Unit, where standard precautions are handled~     (favorable architecture and appropriate practice for hand hygiene), assessment of contact~     precautions to reduce the incidence of acquired bacteria during hospitalization would be of~     interest.~      The investigators design a non-inferiority comparative study to measure the colonization~     pressure in patients hospitalized in two different parts of the department: one unit only~     with standard precautions applied (intervention) and one unit with contact precautions~     (control) as current routine care.~   "
153071|NCT01562756|"~     In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research~     will conduct a pilot study for the purposes of testing equipment, finalizing data collection~     protocol, and training study personnel before conducting the full-scale trial.~   "
153072|NCT01562743|"~     The aims of the trial are to assess the safety and the efficacy of SPM 962 following~     once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese~     patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum~     treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week,~     double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003).~     The trial is also for an exploratory investigation of incidence of augmentation, the most~     problematic complications in dopaminergic treatment.~   "
153073|NCT01562730|"~     Study evaluates the new technique MyoVista™ iECG sensitivity and ability to predict~     myocardial diseases, comparing iECG results with Computed Tomography Coronary Angiography~     findings~   "
153074|NCT01562717|"~     The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients~     with ankle injuries.~   "
153075|NCT01562704|"~     Paracetamol is one of the most widely used analgesic in the world, indicated for the~     symptomatic treatment of fever and pain. The objective of this study is to evaluate the~     mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools~     (functional MRI and test inducing pain by thermal stimulation.~   "
153076|NCT01562691|"~     The purpose of this study is to determine the effect of integrated airway in nasal packing~     material foe patients receiving nasal septoplasty surgery.~   "
153077|NCT01562678|"~     The main purpose of this study is to help us understand the effects of diabetes medication~     Liraglutide on weight loss and hunger. The investigators have already determined what the~     highest tolerated dose of Liraglutide is through earlier human research studies. Liraglutide~     was approved by the FDA in January 2010 for treatment of diabetes.~      The investigators will also study the following:~        1. The impact of Liraglutide on brain responses to food~        2. It's effect on physiological and mental performance~        3. If its effect on the brain differs among obese and lean diabetic subjects.~   "
153078|NCT01562665|"~     The overall aim of the study is:~      To provide accurate and reliable information regarding NSCLC clinical management across MENA~     region in order to detect unmet medical needs of this disease in terms of:~        -  Patient and hospital characteristics.~        -  Diagnostic and treatment approaches: initial and subsequent.~        -  Follow-up patterns in clinical management.~        -  Outcomes: symptoms, death, functionality, quality of life.~        -  Use of resources and burden on patients and health care systems.~   "
153079|NCT01562652|"~     Osteoarthritis (OA) is the most prevalent form of arthritis in the elderly. It is estimated~     that 7% of men and 11% of women over the age of 65 have KOA. The most significant symptoms of~     the disease are pain and functional disability.~      This study has two aims:~        1. To characterise the gait patterns and clinical parameters of patients with knee~          osteoarthritis (KOA) in Singapore at baseline, prior to treatment.~        2. To investigate the changes in gait patterns and the clinical benefits of treatment with~          a new biomechanical device, AposTherapy, for patients with KOA.~   "
153080|NCT01562639|"~     The purpose of this study is to collect following data in patients given Nexium capsule~     (Nexium) in usual post-marketing use as the maintenance therapy for repeatedly~     recurring/relapsing reflux oesophagitis.~   "
153081|NCT01562626|"~     The purpose of this study is to test the safety and efficacy of an investigational drug~     called APS001F when given with flucytosine (5-FC) for treatment of solid tumors. APS001F is a~     recombinant Bifidobacterium longum (a live bacteria normally found in the digestive tract)~     that has been modified to produce an enzyme, cytosine deaminase (CD). The patient will first~     receive an injection of APS001F followed by oral 5-FC. APS001F is expected to go to the site~     of the tumor(s) where the agent will produce CD enzyme. CD enzyme will convert the 5-FC into~     5-fluorouracil (5-FU) which is a standard chemotherapy drug for several types of cancer.~     Additionally, some patients will also receive 10% maltose injection, a sugar that has been~     shown to enhance the growth and effectiveness of APS001F in animals. This is the first study~     where APS001F is being used in humans.~   "
153082|NCT01562613|"~     The primary objective of the study is to evaluate the proportion of hypertensive patients who~     achieve regulation of their blood pressure (BP) levels according to the European Society of~     Cardiology / European School of Haematology (ESC/ESH) Guidelines, after treatment with~     eprosartan for 6 months under standard medical practice conditions. The absolute change in~     Systolic blood pressure from baseline will also be calculated.~      This study also aims in the evaluation of Framingham stroke risk profile score of patients~     treated with eprosartan under standard clinical practice conditions during the observation~     period. Besides the primary and the secondary objective of the study, the assessment of the~     percentage of patients who experienced Adverse Events (AEs), Serious Adverse Events (SAEs),~     Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) (overall and per~     observed event) and the percentage of patients who discontinued treatment prematurely before~     the advent of the 6-month observation period due to toxicity to the study medication~     constitutes another important objective that is related to the safety of the treatment.~   "
153083|NCT01562600|"~     The purpose of this investigation is to collect following data in patients given Nexium~     capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of~     gastric ulcer or duodenal ulcer with non-steroidal anti-inflammatory drug (NSAID).~   "
153084|NCT01562587|"~     This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics~     of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a~     non-bleeding state.~   "
153085|NCT01562574|"~     This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of~     activated recombinant human factor VII and standard treatment compared with standard~     haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric~     congenital heart disease.~   "
153086|NCT01562561|"~     This trial is conducted in Asia and South Africa. The aim of this trial is to compare the~     efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with~     insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.~   "
153087|NCT01562548|"~     Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to~     investigate the evidence that guaifenesin is an effective treatment for upper~     back/neck/shoulder muscle spasm/stiffness and pain.~   "
153088|NCT01562535|"~     Nursemaid elbow or pulled elbow is a condition commonly seen in the emergency department. It~     is the sudden pull of the radial head (a bone in the elbow) in toddlers. Usually occur when a~     parent tries to pull the child by the arm and a clic or clunk is felt with immediate pain~     and unwilling to move the arm. It is not a dangerous condition although it is distressing for~     kids and their parents/caretakers.~   "
153089|NCT01562522|"~     The purpose of the protocol, is to assess the feasibility of conducting a larger trial to~     evaluate the effect of a psychological intervention on the well-being of patients on~     luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and~     their partners.~   "
153090|NCT01562509|"~     The main objective of the proposed study is to assess the effectiveness, feasibility and~     costs of a tailored strategy (developed in accordance with the barriers found and current~     practice) to improve care for patients with non-Hodgkin's lymphomas (NHL), compared to a~     common strategy of 'audit & feedback'.~   "
153091|NCT01562496|"~     The primary goal of this study is to determine the neuroprotective qualities of long-term, in~     home, exercise therapy program in human PD patients. It is hypothesized that an exercise~     intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection).~     The first part involves a pilot-study in which the feasibility of the intervention and~     outcome measures will be tested.~   "
153092|NCT01562483|"~     Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain~     can persist for months or even years and significantly diminishes quality of life. The exact~     underlying cause for this pain persistence is still unclear, which makes its treatment still~     a challenge. The promising analgesic effects of Δ9-THC in previous research, plus the~     improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the~     basis of the present research proposal.~      The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic~     during a long-term treatment (52 days) of persistent postsurgical abdominal pain.~   "
153093|NCT01562470|"~     Study Hypothesis: That the test product will reduce thigh cellulite more that the placebo.~      This will be a double-blind, placebo-controlled study involving subjects with distinctive~     cellulite appearance on both thighs. Subjects will apply test cream to one thigh and placebo~     to the other, by random allocation, and cellulite appearance will be measured at week 0, 8~     and 16. Cellulite photographs will also be assessed by a (study blinded) trial researcher,~     who will assess cellulite appearance on a precisely-measured upper leg area. The subjects'~     own perception of cellulite appearance, from their diaries, will be numerically coded, and~     all three measures will be collated and analysed statistically.~   "
153094|NCT01562457|"~     This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the~     intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two~     administrations of activated recombinant human factor VII in haemophilia patients in a non~     bleeding state.~      The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a~     (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM®~     parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot~     Firmness) and LI60 (Lysis index 60 min after CT).~   "
185928|NCT01130961|"~     The purpose of this study is to determine progression-free survival of lung cancer patients~     who received gefitinib in clinical practice in Thailand.~   "
153095|NCT01562444|"~     The aim of this study is to investigate the immunogenicity response in adults up to 10 years~     after one booster dose. Data collected from this study will allow for greater information to~     prescribers who administer TBE vaccine, so that they can appropriately time the~     administration of booster vaccinations to individuals who received different vaccination~     schedules and who live in tick borne encephalitis endemic regions.~   "
153096|NCT01562431|"~     Background~      An important part of individuals undergoing genetic counseling and/or testing for cancer~     experience psychosocial problems and worries during or after this process. Approximately 20%~     of these individuals experience serious problems, such as fear for cancer in themselves or~     their relatives, family communication problems, unresolved grief, problems in coping with the~     DNA-test-results, difficulties in choices with regard to DNA-testing, preventive surgeries,~     and concerns about insurance or work. Research shows that these problems are frequently~     undetected by the counselors. Within the limited available time of a counseling session, a~     lot of information should be given to the counselee. This information is mostly biomedical~     and provider driven. Therefore psychosocial issues can be underexposed. The use of a brief~     questionnaire, completed by the counselee prior to the counseling session, can serve as a~     tool for the counselor to screen and address the relevant psychosocial issues in a systematic~     manner. Therefore, in 2009-2010 the investigators have developed and validated the~     'Signal-checklist' to identify relevant psychosocial problems frequently encountered in the~     cancer-genetics setting, and need for extra psychosocial services. This 'Signal-checklist'~     can serve as a tool in screening systematically for psychosocial issues, addressing these~     issues and directing appropriate referrals to extra psychosocial services. The Signal-Trial~     will be performed to evaluate the use and effectiveness of the checklist.~      Aim~      The aim of the trial is to evaluate the implementation of a short, self-developed~     cancer-genetics checklist; the 'Signal-checklist', as an aid in 1) facilitating communication~     on psychosocial issues during the genetic counseling session, 2) increasing counselors~     awareness of psychosocial problems of the counselee, and 3) improving the management of these~     psychosocial problems during and after the process of genetic counselling.~      Method~      This study is a collaboration between the family cancer clinics of the NKI-AVL and the UMCU.~     Individuals requesting genetic counseling for the high incidence of cancer in their family~     are invited to participate in the trial. Participants will be asked to complete the 'Signal~     checklist' prior to their counseling visit. Participants (N=264) will be randomly assigned to~     one of the two study arms. The intervention group will receive feed-back on the~     'Signal-checklist', whereas the control group will not receive feed-back. Three weeks after~     the DNA-test disclosure session, participants will be asked to complete again the~     'Signal-checklist' followed by a telephone call by their counselor. Again, the results of the~     'Signal-checklist' will be available to the counselor for participants in the intervention~     group, but not for the control group. Both the genetic counseling session and telephone call~     will be audio taped. Furthermore, all participants will be asked to complete three~     questionnaires on the Internet (or by mail, if preferred); 1) before randomization (3 weeks~     prior to the counseling session), 2) three weeks after the counseling session, and 3) four~     months after the potential DNA-test result disclosure. These questionnaires include items on~     communication during genetic counseling, the need for professional psychosocial support,~     cancer worries, satisfaction with received care, and experiences with the use of the~     'Signal-checklist'. The audio-tapes and completed questionnaires will be used to measure~     psychosocial problems of the counselees, the awareness of the counselors of these problems,~     and the management of these problems. Secondary analysis will be conducted to assess the need~     for extra psychosocial services, satisfaction with genetic counseling, feasibility of~     implementing the 'Signal-checklist' and decreasing psychosocial problems over time.~   "
153097|NCT01562418|"~     Computer settings points to a number of risk factors which may induce the development of Work~     related MSD (WRMSD). In light of the expanded use of computers and the increased occurrence~     of Upper Extremity (UE) WRMSD among computer operators various intervention programs have~     been developed and tested. Nevertheless, many of these programs do not meet the criteria of~     quality and level of evidence.~      The main objective of this study is to use simultaneously a three dimensional (3D) kinematic~     analysis system, surface electromyography (SEMG) and fingertip force measurement system~     (Flexiforce) while typing, to test the efficacy of primary and secondary preventive~     intervention programs aimed at reducing MSD among computer operators.~      Work hypothesis: Significant score differences will be found on the evaluation parameters~     between the research group which underwent ergonomic training with biofeedback, the group~     without feedback, and the control group.The evaluated parameters will correlate with the~     appearance of MSD symptoms and pain and will affect level of function.~      The study will include 66 participants, programmers and computer engineers. The participants~     will be assigned randomly to one of three groups: 1) participants will receive ergonomic~     training with biofeedback; 2) participants will receive ergonomic training without~     biofeedback; and 3) control group, without intervention. Each group will consist of 22~     participants.~      Treatment efficacy will be tested both at work and in the motion lab. In the lab, 3D~     kinematic measurements and fingertip forces relevant to typing while entering a standard text~     will be measured. At the work site, anthropometric and measurements, work station~     measurements, posture observation and questionnaires about, psychosocial status, function and~     pain level will be filled The preventive program will be performed at the workstation after~     the preliminary data collection phase. The program will consist of one group meeting at the~     workplace for all employees participating in the study, and individual instruction at the~     workstation, including 3-6 meetings for the two research groups. Data will be collected~     before and after the intervention program.~   "
153098|NCT01562405|"~     It is possible that the combination of lenalidomide, dexamethasone and ACE 011 may reduce or~     prevent the growth of cancer cells along with improving anemia and bone lesions that~     sometimes occur in people with multiple myeloma.~      This current study is the first study combining ACE 011 with lenalidomide. In this research~     study, the investigators are looking for the highest dose of ACE 011 that can be given with~     lenalidomide and dexamethasone. The investigators will also begin to collect information~     about the effect of the combination of ACE 011, lenalidomide and dexamethasone on multiple~     myeloma.~   "
153099|NCT01562392|"~     The purpose of the study is to study the potential anti-inflammatory- and metabolic effects~     of polyphenols and dietary fibres in a product based on a mixture of several Swedish berries~     and vegetables that is known to have high amounts of polyphenols and other anit-oxidants. In~     addition the purpose is to investigate the effects on cognitive functions of the berry~     product.~   "
153100|NCT01562379|"~     The purpose of this study is to test the impact on child growth of three specially formulated~     complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available~     complementary food, and vs. a control group that receives no food. All groups will receive~     nutrition education related to infant and young child feeding. This will be a~     cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in~     Bangladesh.~   "
153101|NCT01562366|"~     Compare the surgical use of Topaz with the Standard Of Care in the treatment of Greater~     Trochanteric Pain Syndrome (a type of hip pain). The hypothesis is that there is a difference~     between the two treatment groups.~   "
153102|NCT01562353|"~     This is a clinical study on patients who have been prescribed opioids (narcotic pain~     relievers) for the treatment of pain, to determine what genetic factors influence outcome of~     treatment. Procedures include: an initial telephone prescreening, completion of a number of~     questionnaires, and a blood draw to determine genetic factors. Participants will take part in~     a one-time clinic visit, during which all procedures will be completed.~      The investigators hypothesize that several classes of genes, including genes in opioid, pain,~     and reward pathways, will differentiate opioid-dependent subjects from opioid-exposed~     nondependent subjects.~   "
153103|NCT01562340|"~     In this study, the investigators will administer pomegranate juice or fruit extract as a~     targeted antioxidant therapy to hemodialysis patients.~      The investigators will examine whether these pomegranate products will be safe and~     well-tolerated. The investigators will also examine whether these products may lead to~     improvements in blood serum biomarkers of:~        -  oxidative stress status~        -  inflammatory status~        -  endothelial dysfunction~   "
153104|NCT01562327|"~     This multi-center, observational study will evaluate the clinical practice patterns, efficacy~     and safety of RoActemra/Actemra (tocilizumab) in participants with moderate to severe~     rheumatoid arthritis. Data will be collected from each eligible participant initiated on~     RoActemra/Actemra treatment by their treating physician according to local label for 6 months~     from start of treatment.~   "
153105|NCT01562314|"~     Ulcerative Colitis is an inflammatory bowel disease (IBD) effecting large amounts of the~     population. The most common treatment for this condition is 5-aminosalicylic acid (5-ASA),~     however patients failing to respond to this and incurring a flare up are often escalated to~     steroidal treatments.~      This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the~     efficacy and safety of GWP42003 (0mg - 250mg twice daily), compared with placebo, by the~     percentage of participants achieving remission quantified as a Mayo score of 2 or less (with~     no subscore > 1) after 10 weeks treatment.~      This is the first study to determine whether the study medication has a positive benefit for~     subjects on their ulcerative colitis symptom control, as well as effects on inflammatory~     marker cytokines (plasma tumour necrosis factor [TNF]α, interleukin [IL]-2, IL-6), C reactive~     protein [CRP], faecal inflammatory marker (calprotectin), stool frequency (NRS), rectal~     bleeding (NRS), pain (NRS). In addition, various IBD questionnaires are being implemented in~     the study to observe further benefits on the study medication, compared with placebo.~      This study will be a multi-centre, randomised, double-blind, placebo-controlled,~     parallel-group pilot study. There will be two parallel groups of participants (0mg-250mg~     GWP42003 and placebo, twice daily), with a treatment duration of 10 weeks as well as a 7 day~     baseline period and one week follow-up. The two treatment groups of 0mg-250mg GWP42003 and~     placebo will be randomised equally into a 1:1 ratio, with 31 participants in the active IMP~     group and 31 participants allocated placebo treatment.~      In order to be eligible for enrollment in this study, subjects will need to be aged 18 years~     and above (18-65 for Czech Republic) and be clinically diagnosed with with mild or moderate~     ulcerative colitis and on a fixed dose of 5-ASA treatment (0 mg dose of 5-ASA is acceptable)~     and have been on a stable dose for at least 2 weeks prior to screening.~      Eligible subjects will enter the study at a screening visit (Visit 1) and commence a baseline~     period. Each subject will have a Mayo (including endoscopy) assessment conducted to confirm~     eligibility. If eligible, the subject will be randomised into the 10-week treatment phase.~     There are a total of 6 visits in the study.~   "
153106|NCT01562301|"~     The goal of this clinical research study is to find the highest tolerable dose of Anvirzel~     (Nerium Oleander) that can be given to lung cancer patients receiving standard therapy with~     carboplatin and docetaxel. Researchers also want to learn what effect Nerium Oleander may~     have in combination with carboplatin and docetaxel.~   "
153107|NCT01562288|"~     RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received~     chemotherapy with or without trastuzumab may help doctors learn more about the effects of~     trastuzumab on cells. It may also help doctors understand how well patients respond to~     treatment.~      PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer~     treated with chemotherapy with or without trastuzumab.~   "
153108|NCT01562275|"~     This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety,~     tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in~     combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients~     will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study~     treatment is until disease progression or unacceptable toxicity occurs.~   "
153109|NCT01562262|"~     Not all patients with the Obstructive Sleep Apnea Syndrome (OSAS), mostly mild, have~     excessive daytime sleepiness. Sleep fragmentation provides the performance decrease with~     increasing reaction time to external stimuli and correlates with excessive sleepiness. So,~     the study aims at assessing the effect of sleep fragmentation on the Reaction Time and it`s~     maintenance in patients with OSAS compared with healthy, to better clarify were patients with~     and without somnolence differ. For that, will be recruited 30 male volunteers aged between 20~     and 50 year old to participate in the study. They will be distributed in three groups:~     CONTROL (without symptoms of sleepiness and apnea and hypopnea index (AHI) less than 5),~     SS (with AHI between 5 and 15 without symptoms of somnolence) and group CS (with AHI~     between 5 and 15 with symptoms of somnolence). The groups will undergo a polysomnography and~     subsequently, the Test and Maintenance of Wakefulness and PVT Battery Tests. The reaction~     time will be compared, as well as the ability to keep the reaction time over time between~     groups to see whether there is a difference between the motor performance throughout the day~     and the perception of sleepiness.~   "
153110|NCT01562249|"~     The purpose of this study is to verify the effectiveness of a systematic rehabilitative~     program for mastication in patients submitted to orthognathic surgery.~   "
153111|NCT01562236|"~     Background and objectives: Male sex is a risk factor for poor neurodevelopmental outcome~     following preterm birth. The investigators aimed to investigate gender-related differences in~     amplitude-integrated electroencephalography (aEEG) and to correlate these findings with~     neurodevelopmental outcome.~      Methods: Preterm infants born <30 weeks' gestational age between 2000 and 2002 were~     prospectively included. aEEGs obtained within the first two weeks of life were evaluated and~     classified according to background activity, sleep-wake cycling (SWC) and seizure activity.~     Outcome was assessed at three years.~   "
153112|NCT01562223|"~     RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance~     imaging or DCE-MRI and diffusion-weighted imaging or DWI, may provide images of prostate~     cancer or any cancer that remains after biopsy.~      PURPOSE: This trial studies repeated DCE-MRI and DWI in patients diagnosed with prostate~     cancer.~   "
153113|NCT01562210|"~     Phase I dose escalating trial. Primary objective of this study is to define the maximal~     tolerated dose (MTD)of Olaparib in combination with high dose radiotherapy with or without~     daily dose Cisplatin in locally advanced NSCLC. Secondary objectives include to define safety~     profile, determine PK/Pd variables and document preliminary evidence of objective tumor~     response.~   "
153114|NCT01562197|"~     This clinical trial will recruit patients diagnosed with glioblastoma at the time of~     recurrence or progression following prior treatment with surgery, radiation therapy and~     alkylating chemotherapy. Patients will be screened and if found eligible will be randomized~     to one of two treatment arms (1:1 randomization). Patients randomized to the Axitinib~     treatment-arm will be treated with Axitinib until progression (they can be treated after~     progression in the Axitinib plus lomustine arm), unacceptable treatment related toxicity, or~     patients refusal to continue study treatment. Patients randomized to the Axitinib plus~     Lomustine-arm will receive treatment until progression, unacceptable treatment related~     toxicity, or patients refusal to continue study treatment.~   "
153115|NCT01562184|"~     Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression~     that has shown promising efficacy in four recent double-blind, randomized, sham-controlled~     trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing~     its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and~     biomarkers will be measured during the trial.~   "
153116|NCT01562171|"~     Compared to control foods, consumption of 3 cups of cooked lentils given weekly for 12 weeks~     will significantly improve glucose tolerance and lower LDL-cholesterol in individuals with~     high cholesterol and obesity.~   "
153117|NCT01562158|"~     This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the~     efficacy of placebo and activated recombinant human factor VII in patients having undergone~     allogeneic or autologous stem cell transplantation.~   "
153118|NCT01562145|"~     The aim of the study was to investigate the levels of matrixmetalloproteinases and their~     inhibitors in blood samples from patients with rotator cuff tears and compare with blood~     samples from healthy matched controls.~   "
153119|NCT01562132|"~     The purpose of this study is to determine if treatment with two medicines in combination~     (fluconazole and flucytosine) is safe as compared with one medicine alone (fluconazole) for~     the treatment of an early infection with a fungus called cryptococcus.~   "
153120|NCT01562119|"~     The present study was to retrospectively evaluate the long-term outcomes of the cograft~     acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of~     functional regional wounds in burned patients.~   "
153121|NCT01562106|"~     The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence~     imaging in endometrial cancer staging by sentinel node assessment.~   "
153122|NCT01562093|"~     In this study we will investigate the effect of intranasal corticosteroid therapy, which is~     known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.~   "
153123|NCT01562080|"~     The aim of this study is to demonstrate whether, along with dietary recommendations,~     Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a~     change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III~     (ATP III)~   "
185929|NCT01130948|"~     This study investigates the effect of altitude exposure on sleep, breathing and psychomotor~     performance in healthy subjects.~   "
153127|NCT01562028|"~     Rationale:~      Advanced non-small-cell lung cancer (NSCLC) patients harbouring epidermal growth factor~     receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival~     between 9 and 14 months when treated with erlotinib. However, the presence of EGFR mutations~     can only imperfectly predict outcome. The investigators hypothesize that progression-free~     survival could be influenced both by the pretreatment EGFR T790M mutation and by components~     of DNA repair pathways.~      The investigators propose a model of treatment whereby patients with EGFR mutations (single~     or with T790M) can attain a benefit with longer overall PFS when treated with erlotinib plus~     bevacizumab. When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is~     that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups.~   "
153128|NCT01562015|"~     Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior~     therapies. The study will take place globally at multiple study centers. Subjects will be~     enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and~     will repeat this schedule until the cancer gets worse or the subject is unable to tolerate~     ganetespib. The primary goal of the study is to determine how ganetespib is tolerated and how~     active it is in ALK positive NSCLC.~   "
153129|NCT01562002|"~     The purpose of the study is to determine whether allogenic bone marrow stem cell transplant~     is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic~     limbus stem cell transplant.~   "
153130|NCT01561989|"~     This randomized clinical trial studies cholecalciferol and flu vaccine in treating healthy~     participants. Cholecalciferol may increase the immunologic response of flu vaccine in healthy~     participants. Flu vaccine may help the body build an immune response and help prevent flu~   "
153131|NCT01561976|"~     Metformin hydrochloride in its immediate release (IR) form has been successfully used for~     decades in the treatment of type 2 diabetes; however the IR formulation may be associated~     with gastrointestinal side effects (especially nausea, diarrhea) in 20-30% patients, which~     can limit the tolerated dose, reduce adherence and result in discontinuation of therapy.~     Metformin hydrochloride extended release formulations have been developed to overcome these~     problems. In India, extended release formulations of metformin hydrochloride include~     metformin SR 1000mg tablet and combination of metformin hydrochloride SR 1000mg/glimepiride~     2mg tablet. In the combination tablet, only metformin hydrochloride is in the extended~     release form. In view of the fact that extended release metformin hydrochloride is usually~     recommended with a meal, that food is known to affect the pharmacokinetic (PK) parameters of~     metformin and that there is a potential for dose dumping with extended release formulations~     that may lead to side effects similar to IR formulations, a study to estimate the magnitude~     of the food effect for these formulations in fed state compared to the fasting state is~     warranted. This study will be a randomized, single-center, open-label, single-dose,~     three-period, 6 sequence crossover study in 30 healthy adult volunteers to estimate the~     bioavailability of metformin from metformin hydrochloride 1000mg SR tablet given in fasting~     condition relative to metformin hydrochloride 1000mg SR tablet and a fixed dose combination~     of metformin hydrochloride 1000mg SR /glimepiride 2mg tablet, each given in fed condition.~     The safety and tolerability profile of metformin SR 1000mg tablet and metformin hydrochloride~     SR 1000mg/glimepiride 2mg tablet will also be evaluated in this study. The primary PK~     endpoints will be Cmax and AUC (0-∞). The secondary PK endpoints will include AUC (0-t), Tmax~     , T lag, Kel and t1/2. Safety endpoints will include vital signs, ECG, physical examination,~     clinical laboratory tests and adverse event reporting.~   "
153132|NCT01561963|"~     The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be~     affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.~   "
153133|NCT01561950|"~     This trial is conducted in the United States of the America (USA). The aim of this trial is~     to evaluate the effectiveness of activated recombinant human factor VII to mitigate~     experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).~   "
153134|NCT01561937|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the efficacy of activated recombinant human factor VII to mitigate~     experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a~     targeted INR (International Normalization Ratio).~   "
153135|NCT01561924|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM®~     (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in~     a non-bleeding state.~   "
153136|NCT01561911|"~     The Purpose of this study is to evaluate the safety and tolerability, and the biological~     effects of the chimeric anti-CD40 monoclonal antibody Chi Lob 7/4, given intravenously,~     weekly for 4 weeks in the treatment of patients with advanced malignancies refractory to~     conventional anti-cancer treatment.~   "
153137|NCT01561898|"~     The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients~     with schizophrenia over a long term period.~   "
153138|NCT01561885|"~     The aim of this study is to determine if by providing a collaborative, integrated~     pathway-based healthcare compared to the usual healthcare, whether or not this would be~     superior in reducing the length of hospital stay across five high frequency /high risk~     medical diagnoses: Acute Venous Thromboembolism, Acute Kidney Injury, Community Acquired~     Pneumonia, Adult Left Ventricular Heart Failure, and Asthma.~   "
153139|NCT01561872|"~     2 URCC in the Limousin region will be equipped with the automated telesurveillance system.~     Patient will be selected by ward's geriatrician and randomized into two groups after informed~     consent. One group will have cameras installed and the other will not and will act as a~     comparison group. Patient will be assessed twice during the study, at admission in (inclusion~     visit) and at outcome from the URCC (end of study visit). Each assessment implies a standard~     geriatric assessment, a fall questionnaire, a Neuropsychiatric inventory for behavioral~     disturbances and a quality of life questionnaire (EQ5D). Every fall will be considered as~     adverse events and will therefore be listed along the study and characterized in types and~     number.~   "
153140|NCT01561859|"~     The proposed project is designed to examine the effects of cognitive rehabilitation on brain~     structure and function in a randomized trial of 102 early course schizophrenia patients~     treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched~     Supportive Therapy (EST) control, and then followed-up at 1-year post-treatment.~   "
153141|NCT01561846|"~     In this study the investigators aimed at verifying whether consumption of a sheep cheese,~     naturally enriched in ALA, CLA and VA, would modify the plasma lipid and endocannabinoid~     profiles in mild hypercholesterolemic subjects. This study was a 3-week, randomized, double~     blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in~     Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched~     cheese for 3 weeks, with a cross over after 3 weeks of washout.~   "
153230|NCT01560676|"~     Compare the effect of the HEALT[e]TEEN program and a HEALTH[e]TEEN plus coping skills~     training delivered to high school students on BMI, nutrition and physical activity behaviors,~     and self-efficacy over 6 months.~   "
153143|NCT01561820|"~     This is a small pilot trial of a 5 month aerobic exercise intervention in participants with~     MCI (n=20) to begin to compare the effects of randomization to use an exercise buddy or to~     exercise without an assigned buddy. The investigators hypothesize that participants with MCI~     who exercise with a buddy will have higher adherence to the protocol and greater improvement~     in 400 meter walk time.~   "
153144|NCT01561807|"~     The purpose of this study is to determine the antiviral activity and safety of VX-787 given~     to healthy adult volunteers that have been inoculated with the influenza virus.~   "
153145|NCT01561794|"~     The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the~     relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and~     Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in~     hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory~     disease with severe disease or a poor response to other antimicrobials. In addition, the~     efficacy of the ciprofloxacin, in terms of clinical response and microbiological response,~     will be investigated, but as a secondary endpoint.~   "
153146|NCT01561781|"~     This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin~     administered alone and in combination with Vandetanib.~   "
153147|NCT01561768|"~     The purpose of this study is to determine the immune response of three dose levels of the~     Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5~     treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3~     will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will~     receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially~     available trivalent influenza vaccine (TIV). The study will also evaluate the safety and~     tolerability of the Novavax Quadrivalent vaccine.~   "
153148|NCT01561755|"~     The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an~     effective treatment for HIV associated myelopathy.~   "
153149|NCT01561742|"~     This study aims to examine the efficacy of minocycline augmentation in a sample of moderately~     ill outpatients with early-course schizophrenia on their chlorpromazine-equivalent doses of~     second-generation antipsychotic medications. The investigators hypothesize that as compared~     to placebo a 2-month treatment with minocycline in 120 volunteers with early-course~     schizophrenia will result in a more significant improvement in psychopathology (primary~     outcome) and cognitive symptoms (secondary outcome). In addition, cytokine plasma levels will~     be used as another secondary outcome measure to see if treatment-induced changes in total~     PANSS score are associated with changes in cytokine levels.~   "
153150|NCT01561729|"~     This study will evaluate the use of RightBio Metrics' RightSpot device used to determine if~     there is proper placement of a nasogastric or orogastric tube.~   "
153151|NCT01561716|"~     The purpose of this study is to provide energy expenditure data on Wii Fit / Wii Fit Plus~     games as compared with resting and treadmill walking/running.~   "
153152|NCT01561703|"~     This study is designed to look at healthcare utilization following the removal of tonsils and~     adenoids in pediatric patients who are not given an antibiotic following surgery.~   "
153153|NCT01561690|"~     This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the~     effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent~     asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the~     US will be enrolled in this study.~   "
153154|NCT01561677|"~     Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but little~     is known about the consequences of OSAS on the outcome and the survival after stroke. The aim~     of the investigators study is first to evaluate the outcome and the survival of patients with~     stroke depending of OSAS (presence and severity of OSAS) and second to compare the outcome~     and survival of patients with severe OSAS depending on the treatment of the syndrome with~     nocturnal continuous positive airway pressure. The investigators hypothesis is that OSAS is~     associated with worst survival and outcome and needs to be treated at the subacute phase of~     stroke.~   "
153155|NCT01561664|"~     Insulin resistance is one of the main mechanisms involved in metabolic diseases. inflammation~     has been implicated in its pathogenesis, due to innate immunity activation by free fatty~     acids, lipopolysaccharides (LPS) and lactate. Free fatty acids, LPS and lactate activate~     innate immunity in squelettal muscle and adipose tissue via Toll-like receptor 2/4, NFkB,~     IRF3 (Interferon Responsive Factor 3) and cytokines secretion (TNFa, IFN g, IL1b, IL6),~     chemokines secretion (MCP1) and leukotrienes (LTB4). Feed back mechanisms involved in TLR~     signaling pathways as RLI (ribonuclease L inhibitor)/ABCE1, have never been studied in~     inflammation due to obesity. RLI inhibits an endoribonuclease, RNase L, which has been~     recently implicated in TLR signaling The purpose of this study is to analyse the role of RLI~     and RNase L in TLR regulation, and its potential implication in the link between obesity,~     inflammation and insulin resistance in adipose tissue and squeletal muscle in humans.~   "
153156|NCT01561651|"~     Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all~     strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as~     coumadin. Although these blood thinners are effective, they are limited by the risk of~     serious bleeding, by physician and patient reluctance to use, and by noncompliance and~     discontinuation. The left atrial appendage is a structure on the upper chamber of the heart~     that is the most common source of stroke in patients with AF. This structure is easily~     accessible during open heart surgery for removal, and has been an area of interest for stroke~     prevention. However, there is currently no strong evidence that removing it works.~      The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF~     undergoing heart surgery for other reasons to have the left atrial appendage removed or not.~     These patients, other than this small procedure which has been shown to be quite safe, will~     be treated in the usual manner. The full study of 4700 patients, followed for an average of 4~     years, will determine if removing the left atrial appendage can reduce stroke and other~     complications on top of usual therapy. A positive study will change the way heart surgery is~     performed on AF patients and results in a large reduction in the number of strokes in a large~     population. Further, it will promote further research into this approach that could be~     applied beyond AF patients undergoing heart surgery.~   "
153231|NCT01560663|"~     Neoadjuvant (preoperative) chemotherapy is an interesting research tool which allows~     investigators to test new drugs and/or new schedules with a validated surrogate endpoint,~     pCR. It also represents an ideal model to evaluate the relationships between treatments and~     tumor biomarkers. Recent publications have shown that new molecular classifications of breast~     cancer (intrinsic subtypes) have an important prognostic and predictive value. Using~     microarrays for gene expression profiling seems to be the best way to perform this~     classification; nevertheless such assays are not optimally available for common clinical~     practice. The IHC-based classification systems are still useful, as fresh tissue is not~     normally available in clinical practice, and has been shown to correlate well with intrinsic~     classification using gene expression microarrays. Recently the PAM50 gene set provided a risk~     of relapse score not only in ER-positive, node negative patients (similarly to the Oncotype~     Dx Recurrence Score) but also in the ER negative disease. Additionally, the PAM 50 assay was~     highly predictive of neoadjuvant response when considering all patients. This assay added~     significant prognostic and predictive value to pathologic staging, histologic grade, and~     standard clinical molecular markers while using an easy technique that can be performed in~     clinical practice because the qRT-PCR assay can be performed using FFEP tissue.~      Triple Negative Breast Cancer (TNBC) is defined by a lack of expression of ER, PgR and HER-2.~     DNA microarray profiling studies have led to the classification of invasive breast carcinoma~     into five subtypes: luminal A and B, normal breast-like, HER2/neu overexpressing and~     basal-like subtypes, with clinical implications. Later on, a new subtype, the claudin-low,~     has been described. Although not synonymous, the majority of TNBCs carry the basal-like~     breast cancer (BLBC) molecular profile.~      The triple negative subtype accounts for 11-20% of breast cancer in different studies,~     whereas in selected cohorts of patients with advanced breast cancer or African-American~     ethnicity, TNBC may be diagnosed among as many as 23-28%.~      Patients with TN breast tumors treated with standard chemotherapy have a shorter DFS and OS~     than non-TNBC, this difference have been shown to be independent from tumor grade, nodal~     status and treatment in some studies. The peak risk of recurrence occurs within the first 3~     years after initial treatment, with the majority of deaths occurring in the first five years.~      Chemotherapy remains the only systemic treatment option available for TNBC patients. Several~     studies have shown that TNBC/BLBC is associated with an increased response rate to~     neoadjuvant chemotherapy when compared with luminal tumors. However, TNBC patients have a~     significantly decreased DFS and OS in comparison with luminal patients. The largest study~     exploring response and survival in early stage breast cancer treated with neoadjuvant~     chemotherapy was reported by Liedtke et al. Although an increase pCR rate was observed among~     the TNBC patients, they had a shorter lifespan than the non-TN ones. Patients experiencing~     pCR had an excellent OS regardless of hormone receptor expression, but patients with residual~     disease had a significantly shorter survival associated with TNBC compared with non-TN ones.~     This demonstrates that poor OS is derived from chemo-resistant patients (what unfortunately~     represent > 50% of them).~      A relevant problem is the differential response to drugs of TN tumors. These tumors are~     usually treated with multidrug combinations including anthracyclines and taxanes, with pCR´s~     of 28-32%. Only recently, the results of a few small trials combining platinum salts and~     taxanes have been reported, with encouraging results (pCR of 44-77%). The taxane-platinum~     salt combinations have a biological background, since TN not associated BRCA1 mutations are~     sensitive to taxanes and resistant to anthracyclines and platinum salts are effective in TN~     tumors probably because a significant proportion of them have functional DNA repair~     deficiencies.~      The primary objective of the study is to identify predictors of response to~     docetaxel-carboplatin in patients with triple negative primary tumors. Response is defined as~     lack of invasive tumor in breast plus axilla after neoadjuvant chemotherapy (PCR,~     pathological complete response).~   "
153158|NCT01561625|"~     Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary~     disease (COPD). Although resistance exercises increase strength and muscle mass in patients~     with COPD, the response to training appears to be suboptimal in these individuals. A~     dysregulation in the signaling pathways involved in the regulation of muscle mass could play~     an important role in this phenomenon.~      Hypothesis: Proteins involved in muscle mass regulation will be less activated in the~     quadriceps of patients with COPD following the acute bout of resistance training exercise~     compared to healthy age-matched controls.~   "
153159|NCT01561612|"~     The overall goal of the PROBIT study is to investigate the influence of a randomized~     breastfeeding promotion intervention designed to increase the duration and exclusivity of~     breastfeeding (the breastfeeding promotion intervention) on the development of maternal and~     child health outcomes. The hypothesis is that randomization to the intervention will be~     associated with lower child adiposity, lower risk of asthma and atopy, improved lung~     function, and improved cognitive outcomes.~   "
153160|NCT01561599|"~     The study is designed to evaluate the safety and efficacy of an intravenously administered~     drug in recipients of kidneys from cardiac death donors who are risk for developing delayed~     graft function.~   "
153161|NCT01561586|"~     Current standard treatment for locally advanced cervical cancer is cisplatin-based concurrent~     chemoradiation (CRT). Although recently reported meta-analysis studies also demonstrated~     improved local control rates and survival with cisplatin-based chemotherapy concurrent to~     radiation therapy (RT), the optimal cisplatin dose and dosing schedule are still~     undetermined.~      In light of the results of the previous clinical trial, weekly cisplatin 40 mg/m2 considered~     to be a standard regiment in cisplatin doses and dosing schedules. However, our randomized~     phase II trial showed that tri-weekly cisplatin 75mg/m2 has lower toxicities and a better~     outcome in locally advanced cervical cancer.~      In this randomized phase III trial, the investigators investigate that there may be a~     survival difference between weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2~     administration concurrent to RT in cervical cancer.~   "
153162|NCT01561573|"~     PURPOSE: to evaluate the utility of bedside ultrasound performed by emergency physicians in~     the evaluation and reduction of colles fractures as compared with traditional pre and post~     reduction radiographs. With the objectives of assessing Emergency Ultrasounds (EU) utility in~     guiding reduction attempts of Colles fractures and to compare EU to x-ray for the final~     assessment of reduction adequacy.~   "
153163|NCT01561560|"~     The purpose of this crossover study was to evaluate the end-of-day comfort of two~     commercially available, daily disposable, silicone hydrogel contact lenses.~   "
153164|NCT01561547|"~     Mothers can provide pain relief to their newborns, even in the context of intensive neonatal~     care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane~     review, that mothers holding their infants in a bare-chested skin-to-skin position, known as~     Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful~     procedure. While evidence is compelling, leading to recommendations for its use, to date~     there is not a single study on the repeated efficacy to reduce pain. Current guidelines~     recommend sweet taste for minor painful procedures. Although there is some controversy about~     its continued use in this population based on one study with negative neurodevelopmental~     outcomes as well as its potential interaction with dopaminergic development, oral sucrose~     (sweet taste) remains efficacious in decreasing pain response over several weeks. The~     combination of KMC and sucrose is marginally more potent, but again, long term use remains~     unstudied.~      AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to~     usual care (sucrose), and of KMC in combination with sucrose by examining each condition at~     least three times during NICU stay. A secondary aim is to compare these interventions on~     neurodevelopment at discharge from the NICU.~   "
153165|NCT01561534|"~     The rehabilitation of patients affected by defects of the jaws after tumor resection is still~     very challenging. Resection can lead to significant facial deformity, impaired oral functions~     such as speech, swallowing, saliva retention, and concomitant psychological problems.~     Moreover, the loss of teeth and the alveolar and basal jawbone can lead to significant~     impairment of mastication. The reconstruction of such defects with autogenous bone grafts or~     revascularized free flaps has become a valuable means for the rehabilitation of these~     patients. Major benefits of such procedure include an usually low morbidity of the donor site~     and an extensive length of the bone graft. Moreover, vascularized grafts provide a good bulk~     of bone in which to place implants and a satisfactory contour. In fact, after reconstruction,~     local hard and soft tissue conditions often exclude the integration of conventional dentures~     because of the impairment of dental prosthetic retention by thin cutaneous tissue, the~     thickness of subcutaneous tissues, the absence of a perilingual and vestibular groove, and~     the fragility of soft tissues. In Literature it has been well established the high biologic~     value of vascularized fibula grafts regarding the potential of implant osseointegration,~     which seemed to be equal to regional mandibular or maxillary bone and eventually capable to~     provide sufficient stabilization of prosthesis.~      It must be kept in mind that the final prosthetic success may be affected by some~     difficulties in this clinical scenario. These include the limited opening of the~     scar-contracted oral cavity, the huge amount of soft tissue covering the fibula, with little~     information about the profile of the underlying harvested bone, the need for limited bony~     exposure in a field that may well have been irradiated and they all may cause poor~     prosthetically-guided implant positioning and eventually disappointing results in dental~     rehabilitation, either functionally or esthetically. It can be postulated that these~     complications can be overcome, or at least reduced, by adopting the new methods of computed~     tomography (CT)-assisted implant surgery.~   "
153166|NCT01561521|"~     The purpose of this study is to evaluate the onset and duration of action of two~     concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen~     challenge (CAC) model of acute allergic conjunctivitis.~   "
153180|NCT01561326|"~     Objective: Previous studies have suggested that psycho-educational interventions delivered by~     telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further~     explore strategies for enhanced follow-up to medical care recommendations, we studied the~     impact of a theory-guided cognitive-affective barriers counseling intervention, delivered at~     2-4 weeks before the colposcopy appointment, for inner city women. The comprehensive~     telephone barriers intervention was compared to an enhanced comparison group and a group that~     received tailored print materials.~      Methods: Participants (N = 211) were recruited through a colposcopy clinic and randomly~     assigned to: 1) telephone assessment of barriers to follow up adherence recommendations~     combined with tailored telephone barriers counseling; 2) telephone assessment combined with~     tailored barriers print brochure; or 3) telephone assessment with no barriers counseling.~     Participants were assessed at baseline, 1-week, 9 and 15 months post-colposcopy.~   "
157005|NCT01511068|"~     The purpose of this study is to evaluate the therapeutic efficacy of inhaled recombinant~     human GM-CSF in individuals with hereditary Pulmonary Alveolar Proteinosis (PAP) due to~     partial dysfunction of the GM-CSF receptor.~   "
153167|NCT01561508|"~     Type 1 diabetes mellitus (T1DM) is an autoimmune disease in which the body's immune system~     attacks and destroys the insulin producing beta cells of the pancreas. This condition is very~     prevalent, affecting up to 1:400/500 persons worldwide. Type 1 diabetes, previously known as~     juvenile diabetes, usually strikes in childhood, adolescence, or young adulthood, but lasts~     for a lifetime. To date, there have been no treatments that can arrest or reverse the ongoing~     beta cell destruction. The patients affected by this disease require multiple daily insulin~     injections to manage their blood sugars and usually have trouble regulating their blood~     sugars. Moreover, they are at risk for heart disease, kidney failure, eye problems, and other~     complications from this life-long condition.~      The investigators plan to utilize gamma-amino butyric acid (GABA) in children with newly~     diagnosed T1DM. This neurotransmitter is made in the brain from the amino acid glutamate with~     the aid of vitamin B6. There have been some recent studies in diabetic mice utilizing GABA to~     reverse inflammation on the pancreas and improve hyperglycemia. GABA studied in healthy human~     subjects demonstrated that large oral doses of GABA increased insulin secretion from the~     pancreas.~      The investigators propose that GABA given to children with new onset T1DM will be able to~     increase insulin production, suppress glucagon release, and decrease the inflammation~     surrounding the pancreas. The investigators hope this will at least prolong the beta cell~     life after diagnosis, if not lead to a cure for type 1 diabetes.~   "
153168|NCT01561495|"~     This is a study of proton radiotherapy for the pre- or post- operative treatment of patients~     with extremity sarcoma. This study will treat patients in two dose groups:~        1. patients receiving pre-operative proton therapy and~        2. patients receiving post-operative proton therapy. In each dose group, the study is~          divided into two phases. In the first phase of the study, the investigators will~          determine if treatment with proton therapy is safe and can be delivered on a regular~          basis. In the second phase, the investigators will determine if proton therapy has less~          long term side effects compared to standard radiation in both pre-operative patients and~          post-operative patients.~   "
153169|NCT01561482|"~     The purpose of this study is to find out whether the two drugs used in the study, metformin~     and simvastatin, can slow down the speed of rise of prostate specific antigen (PSA) or stop~     its rise or even bring the level down.~      Recently, scientists noticed that men who take metformin to treat their high blood sugar or~     simvastatin to treat their high cholesterol are less likely to develop prostate cancer. Also,~     scientists found that, when these drugs are used in preclinical studies, they can slow down~     the growth of the prostate cancer cells. This study will try to find out whether these drugs~     can actually slow down the growth of prostate cancer in men.~   "
153170|NCT01561469|"~     The objective of this study is to review the local management of patients with~     methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with~     vancomycin or linezolid with the goal to define if any difference exists among these~     antimicrobials in regard to clinical and economic outcomes.~   "
153171|NCT01561456|"~     The purpose of this study is to compare effectiveness and safety of experimental anticancer~     medicine, AXL1717, and docetaxel in patients with squamous cell carcinoma or adenocarcinoma~     of the lung.~   "
153172|NCT01561443|"~     This is the first study focused on features/stereotypes of the first and second-line~     treatment patterns in Russia, comparison of different treatments, and determination of~     effective hormone treatment patterns in real-life practice with evaluation of~     pharmacoeconomic aspects. Study LINE is designed for collection of data on clinical~     effectiveness of second-line hormone treatment and quality of life in patients with breast~     cancer(BC).~   "
153173|NCT01561430|"~     The purpose of this Phase 1/Phase 2 study is to evaluate how the body handles the drug and~     the drug's effect on the body of participants with mild cognitive impairment (MCI) due to~     Alzheimer's Disease (AD) or mild AD and who test positive for amyloid plaque.~   "
153174|NCT01561417|"~     This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence~     between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a~     new formulation stable at 25°C (VII25).~   "
153175|NCT01561404|"~     This is an exploratory study based on the hypothesis that kidney transplant patients treated~     with an immunosuppressive therapy based on an inhibitor of the mammalian target of rapamycin~     (m-TOR) may increase resistance to physical exercise, which would result in an improvement in~     the quality of life of these patients.~   "
153176|NCT01561391|"~     This trial is conducted in North America. The aim of this trial is to compare the safety and~     efficacy of activated recombinant human factor VII in patients with haemophilia A or B~     undergoing major surgical procedures.~   "
153177|NCT01561378|"~     The goal of this study is to determine the potential ability of intranasal insulin to prevent~     post-operative cognitive decline and post-operative delirium in an elderly cardiac surgery~     population.~   "
153178|NCT01561365|"~     The aim of this prospective study was to compare outcomes in patients handled by emergency~     physician according to OAR versus by an orthopedic resident.~      92 consecutive patients with ankle injuries attending our emergency department were divided~     in two groups. The study group comprised 32 patients who arrived during the morning shift and~     were examined by an emergency physician according to OAR. Patients discharged without an~     x-ray were followed in the clinic or by telephone communication. The control group~     constituted 60 patients who were examined during the evening and night shifts by orthopedic~     residents unaware of this study.~   "
153179|NCT01561352|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     assess the efficacy of activated recombinant human factor VII in the treatment of refractory~     haemorrhagic cystitis (HC) following chemotherapy.~   "
153181|NCT01561313|"~     This study will compare injection site pain levels between current Humira® formulation versus~     a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either~     currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological~     naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The~     study is being conducted in two countries, Belgium (3 sites) and the Czech Republic (3~     sites).~   "
153182|NCT01561300|"~     This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract,~     equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.~   "
153183|NCT01561287|"~     Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer~     patients undergo some form of breast reconstruction. Several types of reconstructive~     procedures are available for appropriate patients. A reconstructive sequence consisting of a~     tissue expander followed by permanent implant placement is a popular choice for many women.~     In the past several years, acellular dermal matrices (allografts) have been used at the time~     of tissue expander placement to extend submuscular coverage. Reported benefits include the~     ability to initially fill the expander to a greater extent, improved control of the~     inframammary crease, and possible decrease in capsular contracture rate. Potential~     disadvantages of dermal allografts include foreign body reaction, incomplete tissue~     integration, or increased infection rates. The latter is especially worrisome, as infection~     in the setting of a tissue expander often necessitates the removal of the implant and~     interruption of the reconstructive sequence. There have been a few scattered reports of the~     use of dermal autografts in implant-based breast reconstruction, but they have not been~     widely used. Dermal autografts carry the potential benefit of improved tissue integration and~     lowered complication rates. However, to date there have been no studies which compare~     acellular dermal allograft matrices to dermal autograft for use in breast reconstruction. The~     objectives of this study are to compare dermal allograft to dermal autograft with respect to~     cost, tissue integration, patient satisfaction with scar, and complication profile in~     patients undergoing mastectomy followed by tissue expander/implant reconstruction.~   "
153184|NCT01561274|"~     Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery.~     Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is~     one cause of this hypotension. The higher the spread of the blockade will result in a higher~     incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread~     within the intrathecal space before it will be taken up by the nerve roots. The time that a~     patient remains in one position after medication injection will affect the spread of the~     resultant anesthetic block. A patient who is left sitting for a longer period of time after~     injection of hyperbaric medication will have a lower level of block than someone who is~     placed supine immediately. In this study, the investigators wish to use up down sequential~     analysis to determine the time period a patient should remain seated after intrathecal~     injection of hyperbaric bupivacaine that will result in a 50% rate of hypotension.~   "
153185|NCT01561261|"~     The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis~     of acute compartment syndrome (ACS).~      The immediate objective is to develop a model to accurately predict the likelihood of ACS~     based on data available to the clinician within the first 48 hours of injury (specific~     clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy~     (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring).~      Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome~     made by a panel of clinicians using the following data:~        -  A physiologic fingerprint composed of continuous pressure versus time curve,~          continuous oximetry values, response of muscle to fasciotomy when performed, and serum~          biomarkers of muscle injury (CPK levels).~        -  Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle~          function, presence/absence of myoneural deficit, and patient reported function using the~          Short Musculoskeletal Function Assessment (SMFA).~   "
153186|NCT01561248|"~     The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli~     (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop~     hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization.~   "
153187|NCT01561235|"~     Dietary protein appears to be the most satiating and thermogenic macronutrient. However, how~     protein exerts its effect on appetite is not fully known. The effect have been suggested to~     be related to a higher oxidation rate of protein compared to carbohydrate and fat, and also~     to a greater thermogenic effect causing greater increase in core temperature. The involvement~     of peripheral appetite-regulating hormones has only been sparingly investigated.~      The objective is to investigate the satiating effects of meals with varying content of~     meat-based protein and whether a dose-response effect can be found on appetite-regulating~     hormones and appetite ratings.~      Design: 25 men will participate in the 3-way, randomized, double-blind, crossover study. The~     test meals is isocaloric with 30E% fat and increasing protein content at the expense of~     carbohydrate. Test meals are: normal protein content (NP, 14E% protein), medium-high protein~     content (MHP, 25E%), and high protein content(HP, 50E%). Four-hour subjective appetite~     ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will~     served an ad libitum lunch.~   "
153188|NCT01561222|"~     Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression~     so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.~   "
153189|NCT01561209|"~     The objective of this prospective randomized and controlled study is to evaluate the efficacy~     and safety of low dose of amitriptyline (5 mg) in the management of chronic neck pain.~   "
153190|NCT01561196|"~     The aim of the project is to compare two methods for arterial cannulation. The traditional~     method with ultrasound guided cannulation. The investigators goal is to improve this~     procedure to reduce pain and complications.~   "
153191|NCT01561183|"~     To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement~     for management of human dental pulp with irreversible pulpitis.~   "
153192|NCT01561170|"~     Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous~     insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of~     the disease, primarily among elderly people. Recently, electromagnetic field therapy has been~     tested on various diseases in musculoskeletal system with a beneficial effect. In recent~     years, there has been an increasing interest in using electromagnetic field therapy to treat~     chronically venous ulcer.~      The hypothesis of the investigators is that the electronic magnetic field therapy improves~     the healing process and reduces pain for patients suffering from chronically venous ulcer.~     The investigators assume that the bioactivity is affected by a cellular response which~     affects the DNA synthesis, transcription og protein synthesis.~   "
153193|NCT01561157|"~     The objective of this protocol is to conduct a longitudinal multidisciplinary investigation~     of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and~     mortality in people with these disorders.~   "
153195|NCT01561131|"~     The primary aim is to examine the effect of a high protein intake (from soy or whey protein)~     on weightmaintenance after weight loss in a group of predisposed (severe) obese persons.~     Furthermore, to examine short-term and long-term effect of a high protein intake on appetite~     regulation and diet induced thermogenese (DIT). Finally to examine the effect of calcium on~     weightmaintence, bloodlipid profilen, appetite regulation and DIT.~      The study is a parallel RCT with a weight loss (WL) period (8 weeks on very low calorie diet)~     and a weightmaintence (WM) period (24 weeks daily intake of supplement). 200 overweight/obese~     subjects will be enrolled into the study and randomized to placebo (maltodextrin), soy~     protein, whey protein or calcium enriched whey protein supplement. At baseline (week 0),~     after the WL period (week 8) and after WM period (week 24) body weight and composition will~     be measured and blood samples will be collected. Meal test will be performed at week 0 and 24~     (examining both appetite regulation and DIT). Urine and feces will be collected three times~     during the study. Subjects will receive dietary counseling (in groups) regularly during the~     study and body weight will be measured at each visit.~   "
153196|NCT01561118|"~     Physical activity is considered essential for optimal health, development, socialization and~     well-being of children. However patients with end-stage renal disease (ESRD) are often~     restricted from participation in exercise activities. This is especially true for children on~     hemodialysis (HD). As a consequence their exercise capacity is reduced, both before, but most~     impressively after HD. In a nationwide randomized, multi-center design this study aims to~     proof the influence of an individualised endurance training program by bicycle ergometer~     performed during dialysis on the efficacy of HD, measured as single pool Kt/V. Secondary~     goals are to enhance physical performance, physical and mental well-being, and to improve~     measurable blood and treatment parameters (e.g. haemoglobin level, amount of medication). A~     positive impact of physical activity was observed in adults on HD, although most studies did~     not address this issue in a randomised protocol. Despite this beneficial evidence in adults,~     sport is still not integrated as part of standard care in patients on maintenance HD. The~     study protocol, developed in close collaboration with the German Sport University Cologne,~     differs substantially from previously published reports as it uses bicycle ergometer training~     in an upright position outside the dialysis couch and adapts the intensity of intervention to~     the patient's capabilities. Based on the expected results the investigators will develop an~     individualised training program to be integrated in the standard care of (pediatric) patients~     on maintenance HD.~   "
153197|NCT01561105|"~     Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to~     Collaborative Treatment(IMPACT) collaborative care management program for late-life~     depression.~   "
153198|NCT01561092|"~     Growing international scientific evidence has indicated a positive effect of SSRI treatment~     (serotonin reuptake inhibitors) after stroke, beyond its antidepressant effect. We wish to~     conduct a prospective randomised double blind placebo-controlled multicenter study of the~     combined neuroprotective and antithrombotic effects of SSRI treatment after stroke. Deletion~     of the SERT (serotonin transporter) gene may influence this treatment effect and may in~     itself be a risk factor for stroke, an aspect we also wish to explore.~      Hypotheses:~        1. SSRI treatment commenced in the acute phase of stroke (day 2-5) protects against new~          thromboembolic events and leads to better rehabilitation.~        2. A specific SERT genotype is associated with an increased risk of first ever stroke.~        3. A specific SERT genotype is associated with a higher risk of post stroke depression.~      600 stroke patients will be randomised to either escitalopram or placebo treatment in a 1:1~     ratio and genotyped according to SERT polymorphisms. The treatment and follow up period is 6~     months. During these 6 months there will be 2 clinical follow up visits, one telephone~     control and one visit to evaluate compliance regarding medication. Patients who had an MRI as~     a part of the routine investigations done upon admission (approximately 300 patients) will~     have a control MRI after 6 months.~      Additionally 400 patients, not eligible for participation i the randomised controlled trial,~     will be genotyped and answer questionnaires after 1 and 6 months.~   "
153199|NCT01561079|"~     This research will track the longitudinal neurobehavioral development of the~     buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine~     the safety of this medication for use during gestation, the relationship between maternal~     physiologic changes due to buprenorphine administration and newborn functioning, and to~     determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence~     Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar~     project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way~     the investigators inform the treatment of the opioid dependent woman during pregnancy and her~     infant after birth.~   "
153200|NCT01561066|"~     Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output~     enterocutaneous fistulas. However, there are only few studies that report autologous glue~     application in a larger patient group or clinical-controlled studies in this setting. The aim~     of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin~     glue (PRFG) in the treatment of low-output digestive fistulas and compare them with~     conservative management without the use of adjuvant application of FG into the fistulous~     tract.~   "
153201|NCT01561053|"~     The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral~     and global domains based on the different applicable psychometric batteries and scales.~   "
153202|NCT01561040|"~     Dry eye disease (DED) is a common but often inadequately treated disease of the tears and~     surface of the eye. It can cause poor vision and chronic pain and is more frequent with~     increasing age. The 1995 Report of the National Eye Institute/Industry Workshop on Clinical~     Trials in Dry Eye defined dry eye as a disorder of the tear film due to tear deficiency or~     excessive evaporation, which causes damage to the interpalpebral ocular surface and is~     associated with symptoms of ocular discomfort. The International Dry Eye Work Shop (DEWS)~     committee subsequently defined dry eye as a multi-factorial disease of the tears and ocular~     surface that results in symptoms of discomfort, visual disturbance, and tear film instability~     with potential damage to the ocular surface. It is accompanied by increased osmolarity of the~     tear film and inflammation of the ocular surface. Typically, symptoms associated with dry~     eye disease include ocular burning, foreign body sensation (sand or grit), photophobia (light~     sensitivity), and other symptoms that result in overall long term discomfort in patients. The~     proposed eight week feasibility study if dry eye subjects confirmed elevated osmolarity and~     symptoms respond to nutritional therapy.~   "
153204|NCT01561014|"~     This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when~     given together with oxaliplatin, fluorouracil, and radiation before surgery and alone after~     surgery in treating patients with locally advanced cancer of the esophagus and~     gastroesophageal junction. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving combination chemotherapy together with erlotinib~     hydrochloride and radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving erlotinib hydrochloride after~     surgery may kill any tumor cells that remain after surgery~   "
153205|NCT01561001|"~     Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous~     humor via the trabecular meshwork towards the systemic circulation. This may lead to an~     increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to~     lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss.~     Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains~     uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be~     indicated. Deep sclerectomy with a collagen implant (DSCI) is a non-penetrating surgical~     procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous~     outflow. This forms the rationale to conduct this prospective, open label study to assess the~     24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and~     after DSCI.~   "
153206|NCT01560988|"~     This study plans to look at whether borage and echium seed oils (natural oils from two~     plants) help decrease asthma symptoms and affect cells involved in inflammation. The~     investigators also want to look at how these plant oils decrease the generation of~     inflammatory cells in people with asthma.~   "
153207|NCT01560975|"~     Sleep apnea is characterized by repetitive episodes of decreased or interrupted airflow in~     the upper airways during sleep. Obstructive sleep apnea syndrome (OSAS) is the most common~     sleep-related breathing disorder and is characterized by repeated partial or complete upper~     airway collapse, gasping episodes, daytime sleepiness and fatigue. Once suspected, the~     diagnosis is made on the basis of anamnesis and a polysomnography (PSG) using the so-called~     respiratory disturbance index (RDI) to grade OSAS. Standard therapy consists of continuous~     positive airway pressure (CPAP) during sleep to prevent upper airway collapse. The~     association between OSAS and glaucoma has been extensively studied, although a few reports~     have been non-confirmatory. OSAS has been associated with reduced ocular blood flow, leading~     to hypoxia and hypercapnia, and as such, may represent a risk factor for glaucomatous optic~     neuropathy. OSAS has also been related to loss of nycthemeral rhythm of intraocular pressure~     (IOP). In addition, CPAP has been reported to increase IOP when used during nighttime.~      The purpose of this study is to investigate how IOP varies in time, particularly during sleep~     in OSAS patients with or without glaucoma, and if the IOP variations are associated with the~     use of CPAP. IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable~     investigational device using a contact lens sensor that monitors the IOP fluctuation~     continuously over 24-hours.~   "
153208|NCT01560962|"~     Objective: To determine the preliminary outcome of external over the counter (OTC) povidone~     iodine (PI) application in the management of chronic and acute blepharitis vs. currently~     clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or~     antibiotic/steroid ointments.~      Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled~     and randomized into four groups.~      In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI~     twice daily for 10 days and the other eye with no intervention.~      In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI~     and the other eye will receive warm soaked eyelid wash.~      In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI~     and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10~     days.~      In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI~     and the other eye will receive tobradex ointment applied to the lid margin.~      Subjective variables assessed included itchiness, foreign body sensation and eyelid edema~     (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland~     plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the~     initiation and at the cessation of treatment were obtained.~   "
153209|NCT01560949|"~     The goal of this clinical research study is to learn if a chemotherapy combination called~     modified Folfirinox (or mFolfirinox), followed by a combination of gemcitabine and radiation~     therapy, followed by surgery, can help to control pancreatic cancer. The safety of this~     treatment will also be studied.~      mFolfirinox consists of 5-FU, oxaliplatin, and irinotecan. These 3 drugs, along with~     gemcitabine, are each designed to block the growth of cancer cells, which may lead to cancer~     cell death.~   "
153210|NCT01560936|"~     The purpose of this study is to determine the contamination rate of the parents cell phone in~     a newborn intensive care setting and identify the types of bacteria contaminating the cell~     phone as well as evaluating the effectiveness of an antimicrobial gel in reducing the~     transmission of bacteria from the cell phone to the parents hands.~   "
153211|NCT01560923|"~     This is a randomized, double blind, multi-institutional phase II therapeutic study of~     Indoximod or placebo after the completion of standard of care sipuleucel-T (Provenge®) in men~     with asymptomatic or minimally symptomatic metastatic prostate cancer that is castration~     resistant (hormone refractory). Patients are randomized to receive either twice daily oral~     Indoximod or placebo for 6 months beginning the day after the third and final sipuleucel-T~     infusion.~   "
153212|NCT01560910|"~     Study design and objective The primary outcome of this prospective cohort study was to~     identify the endoscopic findings that have diagnostic value for the prediction of NERD~     (minimal change esophagitis) by using HD endoscopy with i-scan. The secondary outcome was to~     evaluate the response to proton pump inhibitor (PPI) in GERD patients with or without minimal~     change esophagitis.~   "
153213|NCT01560897|"~     The aim of this pilot study is to evaluate the validity and reproducibility of a functional~     test Test C13 ureogenesis to measure in vivo, using the methodology Laboratory of Metabolic~     Diseases of Cliniques Universitaires Saint-Luc~   "
153215|NCT01560871|"~     Patients with chronic heart failure need a safe and effective exercise program that will~     improve their quality of life. For this study, we will determine if adult chronic heart~     failure patents assigned to an experimental exercise group of walking and Inspiratory Muscle~     Training (IMT) program will have an additional beneficial effects on respiratory muscle~     strength (PImax), cardiovascular endurance, quality of life, walking speed, heart rate~     variability, and physical activity level compared to subjects who are assigned to the home~     walking and sham Inspiratory Muscle Training (IMT) program.~   "
153216|NCT01560858|"~     The purpose of the protocol is to describe treatment patterns among patients with prostate~     cancer prior to diagnosis of castration-resistant state.~   "
153217|NCT01560845|"~     In recent years, the safety and efficacy of autologous bone marrow stem cells infusion~     (ABMSCi) therapy were confirmed. The investigators attempted to infuse autologous bone marrow~     stem cells (ABMSC) through inserting a catheter into right gastric artery as far as proper~     hepatic artery after finishing open abdominal portal hypertension surgery. The present study~     was designed to treat bleeding from esophageal varices and hypersplenism and hopefully to~     improve the liver function as well.~   "
153218|NCT01560832|"~     Clostridium difficile is an important pathogen, causing disease that ranges from mild~     self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C.~     difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and~     for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two~     large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical~     illness. Primary risk factors for C. difficile clinically apparent infection include~     antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥~     65 years), and increased length of hospital stay. The incidence of CDI both in the hospital~     and the community is important in the understanding and characterization of the disease and~     its prevention. This observational, epidemiological study will advance the investigators~     understanding of CDI risk factors in several hospitals and possibly the community in the Asia~     Pacific region.~   "
153219|NCT01560819|"~     Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder~     affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2~     different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut~     Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a~     treatment option for Clostridium difficile colitis and UC. The literature supports strong~     evidence for the plausibility of using GMT for patients with IBD associated colitis,~     especially for patients with UC.~      This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric~     gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to~     evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis~     (UC and CD with colonic involvement only) will be approached for GMT as a treatment option~     for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily~     on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be~     done at their regularly scheduled clinic follow up.~      Healthy donors >18 years of age will be chosen by the family, inclusive of immediate family~     members and friends. Donors will be required to complete a screening questionnaire, provide~     medical history, and undergo blood and stool tests.~   "
153220|NCT01560806|"~     A quasi-experimental study design was chosen to compare the model of hypertension management~     at commune-level with conventional management for people with high blood pressure in two~     communes (one for intervention versus one for reference).~      A intervention model included the commune-based programme on hypertension management combined~     with comprehensive health promotion campaigns~   "
153221|NCT01560793|"~     This study will evaluate the safety and immunogenicity of VAX161B [STF2.HA5 H5N1], a~     recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of~     doses.~   "
153222|NCT01560780|"~     This is a randomized-controlled clinical trial that will randomize 120 patients undergoing~     clinically-indicated coronary artery bypass graft surgery to prasugrel at a dose of 10 mg~     daily or matching placebo for 12 months, starting at the time of hospital dismissal from~     surgery. The primary goal of the study is to determine whether prasugrel administration will~     prevent thrombus (clot) formation within a saphenous vein graft at 12 months, as examined by~     optical coherence tomography.~   "
153223|NCT01560767|"~     Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg and Ketorolac 30mg~     reduces postoperative pain following primary total knee replacement compared with the current~     standard treatment of femoral nerve blockade.~   "
153224|NCT01560754|"~     The primary objective of this study is to demonstrate that transdermal nicotine treatment~     retards disease progression as measured by change in total Unified Parkinson's Disease Rating~     Scale (UPDRS)(part I, II, III)score between baseline and after 52 weeks of study treatment~     plus two more months wash out (60 weeks).~   "
153225|NCT01560741|"~     The critical nature of respiratory diseases, the continuously increasing prevalence of these~     conditions, and the subjective perception of patients vis-à-vis their pulmonary function and~     health status underscore the importance of home telemonitoring. These conditions are critical~     and necessitate close and regular monitoring that may be achieved at distance using~     telemonitoring. This study will assess a number of measures both at baseline and~     post-intervention from a number of domains, including Arterial Blood Gases (ABG),~     BiPAP-related data, chronic respiratory failure symptoms, health-related quality of life,~     patients satisfaction and utilization of healthcare resources.~   "
153226|NCT01560728|"~     Youth with mental illnesses are disproportionately represented in juvenile correctional~     facilities and limited evidence exists about effective treatments in this setting. This study~     will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be~     efficacious in community settings, to the correctional setting and study the feasibility of~     its implementation. Conducted within Texas youth correctional facilities, the findings will~     be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to meet the~     unique needs of incarcerated youth and the correctional system, one of the priorities~     outlined in the National Institute of Mental Health Strategic Plan.~   "
153227|NCT01560715|"~     The purpose of this study is to evaluate the short-term safety and efficacy of a single~     intravitreal injection of autologous bone marrow stem cells in patients with retinitis~     pigmentosa.~   "
153232|NCT01560650|"~     The current international Continuous Renal Replacement Therapy (CRRT) replacement fluid doses~     of 35 ml/kg/h is better, but the result is according to white people, black people . It is~     Whether the best amount of replacement fluid for Chinese people, it is unclear.~     Especially,there is little evidence about the optimal dose from randomized trials in Cardiac~     surgery associated acute kidney injury (CSA-AKI )required CRRT,According to the clinical~     situation, the design of replacement fluid to 25 ml/kg/h.The observation of two doses 14~     days, 28 days, 90 days survival and renal function.~   "
153233|NCT01560637|"~     This study is an international, multi-center, open-label study designed to provide oral~     treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have~     completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety~     of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.~   "
153234|NCT01560624|"~     This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C):~     placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial~     Hypertension (PAH) who are currently receiving background oral monotherapy for at least 30~     days at randomization for their PAH. Study visits will occur in four week intervals for the~     first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to~     first clinical worsening event and the 6-minute walk test at Week 24. Study procedures~     include routine blood tests, medical history, physical exams, disease evaluation, and~     exercise tests. Patients who complete all required assessments will also be eligible to enter~     a long-term, open-label, extension study (TDE-PH-311).~   "
153235|NCT01560611|"~     In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain~     and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused.~     This phenomenon is related to silent peripheral vasoconstriction that is not clinically~     available but threatens end-organ perfusion and carries the risk of multi-organ failure. By~     measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present~     study aims at detecting silent peroperative hypoperfusion episodes. The investigators~     hypothesize that gradient, measured during the surgical procedure, will predict the~     occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate~     concentration, measured in intensive care unit.~   "
153236|NCT01560598|"~     We aimed to risk faoctors for GERD and association between visceral obesity, plasma~     adipoline(leptin, adiponectin, IL-6, TNF-α)and development of reflux esophagitis in healthy~     Koreans.~   "
153237|NCT01560585|"~     This is an open label study of isotretinoin, a medication which is FDA approved for treatment~     of other conditions to determine initial safety in Alzheimer's disease.~   "
153238|NCT01560572|"~     A prospective, open, randomized trial, in which the investigators aim to achieve optimal~     immunosuppression after renal renal transplantation with maximal reduction of side effects,~     especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies.~     Immunosuppression without steroids and CNI minimization is compared to standard~     immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.~   "
153239|NCT01560559|"~     Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and~     Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient~     in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as~     surgical myotomy but less invasive and more effective with less complications than endoscopic~     pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100%~     efficacy and no clinically significant complications. The present clinical trial with study~     the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.~   "
153240|NCT01560546|"~     A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.~      Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by~     hyperinsulinaemia and insulin resistance.~      Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with~     low normal levels of bioavailable testosterone and type 2 DM.~   "
153241|NCT01560533|"~     The project aims to understand better how patients live the event of cancer and live its~     consequences on their bodily representations. In the study, the dynamic of the body image is~     not restricted to appearance but include sensations and visions of the inner body, what~     explains the choice of peritoneal cancer, and the treatment by cytoreductive surgery and~     HIPEC.~      The three objectives of the study are:~        -  identifying the impact of the representations of the treated body on the psychological~          strategies to cope with the disease, the bodily changes and the prospects of life;~        -  making explicit the positive or negative impacts of these representations on the~          relationship between patients and health professionals (easing factors,~          misunderstandings, negotiations, etc.);~        -  associating the health professionals with the study in its course and evaluation in~          order to elaborate a methodological collaborative approach between patients, health~          professionals and researchers in social sciences.~   "
153242|NCT01560520|"~     Stroke is the leading cause of adult disability in Europe and United States and the second~     leading cause of death worldwide and affects more than 10,000 Danes each year.~      Studies in a late and stationary phase after stroke have shown that physical rehabilitation~     is of great importance for survival and physical ability of these patients, however many~     studies show that patients lie or sit next to their bed under hospitalization for more than~     88.5 % of the daily hours. Physical activity in stroke patients has never previously been~     measured immediately after debut of symptoms; furthermore there is no knowledge about the~     optimal dose of physical rehabilitation for these patients.~      Accelerometers, small measuring devices, are a relatively new way to measure physical~     activity precisely, and hence it is possible to obtain an objective measure of how active~     stroke patients are in the first week after admission. The accelerometers measure a variable~     voltage, depending on the range and intensity of movement. They can measure movement~     dependent of the placement of the accelerometer, for instance over the hip, arm or leg.~     Studies confirm their reliability, even in patients with abnormal gait, such as stroke~     patients.~      Another approach of studying the effects of physical activity and rehabilitation is through~     the examination of biomarkers. Studies have shown that biomarkers released during physical~     activity can inhibit biomarkers released after tissue injury in the brain, as seen after~     stroke. These brain biomarkers cause further damage and studies show that the higher the~     levels, the higher the damage. It is therefore obvious to examine whether physical activity~     rehabilitation can down regulate this destructive process in patients with stroke.~      Clarification of physical activity in stroke patients immediately after debut of symptoms and~     examination of both the biochemical aspects of physical rehabilitation as well as the optimal~     dose of physical rehabilitation is of great importance for many patients, their relatives as~     well as of a great socioeconomic importance.~      The purpose of the project is to describe the amount and pattern of physical activity in~     stroke patients in the first week after admission. The investigators hypothesis is that~     patients are inactive for most of the time during hospitalization, activity being correlated~     with severity of stroke, but not with age, BMI and sex.~   "
153243|NCT01560507|"~     The purpose of this study is to ascertain: 1) the rate of smoking cessation obtained using an~     adaptive treatment algorithm developed in previous clinical trials, in order to calculate~     cost-effectiveness of the treatment; 2) the relationship between genotype and response to~     cigarette smoking cessation treatment.~   "
153244|NCT01560494|"~     This study describes the development and validation of a structured training and assessment~     curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that~     residents trained using the STAC curriculum would demonstrate superior technical skills in~     the operating room compared to residents that were trained using a traditional curriculum.~   "
153245|NCT01560481|"~     Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the~     treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in~     naive patients with type 2 diabetes.~      The objective of this study is to evaluate the safety, tolerability and pK profile of~     Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single~     dose, in step A. In step A will be included 25 volunteers.~      In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin~     Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be~     included 24 volunteers.~   "
153246|NCT01560468|"~     This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver~     Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061~     oral monotherapy will be safe in adults during and after liver transplantation and that~     therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV~     infection.~   "
153247|NCT01560455|"~     This study will examine use of two-stent versus one-stent techniques for patients with large~     calibre bifurcation lesions including significant side branch disease.~   "
153248|NCT01560442|"~     The purpose is to study the relation between pupillary diameter measured under scotopic~     conditions, and the pain thresholds measured at the time of peak and residual effect of~     methadone/buprenorphine in opiate-dependent patients following a substitution program.~   "
153249|NCT01560429|"~     Postoperative thoracotomy pain is normally managed with an epidural catheter and continuous~     epidural analgesia (CEA). However, for some surgical procedures, patient controlled epidural~     anesthesia (PCEA) is more effective but little research has compared the two methods~     following thoracotomy. The current randomized, prospective clinical investigation did just~     this. Following institutional ethics approval 52 patients scheduled for thoracotomy were~     recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was~     sited preoperatively. Postoperatively all patients were titrated on continuous epidural~     infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) until pain scores were stable at ≤3~     on a numeric rating scale (NRS). Then they were allocated to their preoperatively determined~     randomization (either remained on continuous epidural infusion or they were switched to~     receive 2/3 of the stabilized background dose via continuous epidural infusion with the~     option to self-administer the remaining 1/3rd of the dose via PCEA. Participants remained on~     their allocated analgesic regimens for 48 hours postoperatively. The primary outcome was~     consumption of local anaesthetics/opioids. The secondary outcomes were worst pain and pain~     while coughing (0-10 NRS).~   "
153250|NCT01560416|"~     Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in~     other research studies and laboratory experiments. It has also been studied in phase I~     trials, where the appropriate dosing has been determined. Ganetespib is considered an HSP90~     inhibitor. By blocking HSP90, ganetespib is thought to reduce the ability of cancer cells to~     become resistant to treatment.~      Fulvestrant is a hormonal therapy that works by attaching to estrogen receptors. In doing so,~     it can block the effect of estrogen on cancer cells. In addition, fulvestrant causes a~     decrease in the number of estrogen receptors. Fulvestrant is a drug that is approved by the~     FDA for treatment of metastatic, hormone receptor positive breast cancer, based upon the~     results of phase III clinical trials.~      In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It~     is not known whether this is true in humans. In this research study, we are evaluating the~     effect of the addition of ganetespib to fulvestrant in participants with hormone~     receptor-positive, metastatic breast cancer.~   "
153251|NCT01560403|"~     This study is a 1-year open label extension study to collect long term efficacy and safety~     data from patients who have completed approximately 2 years of dosing in Study CL0600-021.~   "
153252|NCT01560390|"~     The aim of the study is to evaluate the impact of ketamine associated to an opioid for~     sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be~     drive by nurses according to an algorithm. The investigators will evaluate the quantity of~     opioates used in each arm and the safety of ketamine.~   "
153253|NCT01560377|"~     The purpose of this study is to demonstrate that NIR fluorescence angiography using the~     PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT System or PINPOINT) can assess~     viability of colon tissue during laparoscopic left colectomy. This information will provide~     the surgeon with clinically relevant information in assessing whether or not the tissue has~     adequate blood supply in the lower section of the colon prior to a colectomy.~   "
153254|NCT01560364|"~     This is a prospective observational clinical multicentric study in ICU with acute renal~     failure requiring renal replacement therapy.~   "
153255|NCT01560351|"~     The aim of this study is to evaluate the effect of repeated low-frequency Transcranial~     Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with~     gambling cues, on gambling craving. Participants are pathological gamblers. A single real~     stimulation and a single shame stimulation are administered in a random order for each~     participant (cross-over study).~   "
153256|NCT01560338|"~     The purpose of the study will help us understand the complex interaction between hypothermia~     (cooling) and pharmacogenetics (how specific genes effect how drugs are handled), and their~     impact on how routinely given sedation drug are broken down and used by the body when given~     to children after cardiac arrest (when heart stops pumping blood) and are critically ill.~   "
153257|NCT01560325|"~     A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting~     toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection~     on twice-weekly schedule in patients with advanced solid cancers failed to standard therapy.~     The usefulness of the this regimen is evaluated by response rate, progression free survival~     and vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI) or DWI.~   "
153961|NCT01551082|"~     Discharging patients home with air leak and chest tube to portable drainage device after~     thoracic resection is cost effective and safe without compromising patients outcome or~     satisfaction. Despite good outcomes this practice is not done universally by thoracic~     surgeons.~   "
153258|NCT01560312|"~     Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic.~     Patients with refractory hypertension will be randomized in 1:1 manner either to renal~     denervation plus optimal medical antihypertensive treatment without spironolactone or to~     antihypertensive treatment alone including spironolactone if not contraindicated. The primary~     end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year~     after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients.~     Patients follow-up is planned for 3 years.~   "
153259|NCT01560299|"~     Iodine therapy is the best treatment for graves disease.Most patients receive methimozale~     prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.~      Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and~     others prefer longer off - methimazole period which bothers most patients. This study aimed~     to evaluate optimum time for methimazole discontinuation in graves disease.~   "
153260|NCT01560286|"~     The primary objective of the study is to evaluate the effect of dosing regimens of multiple~     subcutaneous (SC) doses of rAvPAL-PEG to induce an early and sustained Phe reduction while~     decreasing the frequency and severity of hypersensitivity reactions in patients with PKU.~   "
153261|NCT01560273|"~     The purpose of this clinical investigation is to evaluate the clinical outcomes of subject~     with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™~     Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry~     Disability Index (ODI) improvement and success of fusion.~   "
153262|NCT01560260|"~     This phase II trial studies how well linsitinib works in treating younger and adult patients~     with gastrointestinal stromal tumors. Linsitinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
153263|NCT01560247|"~     To determine the revascularization rate, clinical efficacy and safety of the CE-marked~     MindFrame System in ischemic stroke patients~   "
153264|NCT01560234|"~     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics~     of single ascending doses of AZD8848 in healthy subjects.~   "
153265|NCT01560221|"~     The combination of using injection drugs, smoking crack cocaine, having multiple sex~     partners, and inconsistent condom use results in substantial risk for acquiring and~     transmitting HIV, and many drug dependent adults who have been arrested on charges of~     prostitution fit this profile. Existing interventions for reducing HIV risk have had limited~     efficacy in drug-dependent sex workers, and criminal justice approaches have been ineffective~     despite their high cost. A potentially ideal alternative is to divert drug-dependent~     arrestees from prosecution to a treatment that reduces drug use and HIV sex risk behaviors,~     while providing job skills training and promoting community employment to alleviate the~     financial need to continue sex work. In order to provide an effective therapeutic alternative~     to criminal prosecution, the investigators propose to develop a multifaceted intervention~     that includes opiate agonist treatment (i.e., methadone OR buprenorphine) and the Therapeutic~     Workplace. The Therapeutic Workplace is a supported environment in which participants are~     required to provide drug-free urine samples to access paid job skills training or employment~     and to maintain the maximum rate of pay. The overall intervention is designed to reduce drug~     use and HIV risk behaviors, and simultaneously promote employment. The proposed project is a~     2-year Stage I behavior therapy development effort that will include the development,~     manualization and pilot testing of a Therapeutic Workplace intervention tailored to~     drug-dependent adults arrested for prostitution. In the pilot study, the investigators will~     recruit opiate- and cocaine-dependent adults arrested for prostitution from the Eastside~     District Court in Baltimore. Eligible individuals will be offered methadone treatment in lieu~     of prosecution and will be required to remain in methadone treatment for 90 days to have the~     charges against them dropped. After enrolling in opiate agonist treatment, the diverted~     individuals will be invited to participate in the pilot study. Interested individuals will be~     randomly assigned to receive the standard opiate agonist treatment services or these services~     plus the Therapeutic Workplace. The Therapeutic Workplace has two phases. In Phase 1,~     participants will be offered four months of stipend-supported job training in the Therapeutic~     Workplace. In Phase 2, participants will be encouraged to seek employment in a community job~     and will receive wage subsidies for four months for maintaining community employment or~     engaging in supervised job seeking. Throughout both phases, participants will be required to~     provide drug-free urine samples to receive Therapeutic Workplace wages (training stipends in~     Phase 1 and wage subsidies in Phase 2). The wage subsidy program will include drug testing~     managed by a national supplier of drug-free workplace services. Overall, this treatment could~     serve as a novel and ideal intervention for drug-dependent adults arrested for prostitution~     while reducing criminal justice costs.~   "
153266|NCT01560208|"~     Corneal diseases are a major cause of blindness worldwide, and corneal infections are a~     substantial cause of blindness in Asia. The aim of the Asia Cornea Society Infectious~     Keratitis Study (ACSIKS) is to study infectious keratitis (corneal infections) in Asian~     countries, so as to improve strategies for prevention and treatment, and to reduce the burden~     of blindness in Asia.~      The first phase of ACSIKS is an 18-month observational study involving 11 eye hospitals in 8~     Asian countries; these hospitals manage more than 6700 cases of corneal infections every~     year. From the first quarter of 2012, all patients with a corneal infection will be recruited~     and a standard ACSIKS protocol will be applied; this protocol includes the use of a common~     set of study forms and a suggested panel of microbiological examinations. However, each~     centre will be continue to treat their patients with the anti-infective therapy standard for~     their centre. Data will be recorded for each patient for a period of six months, including~     their medical and surgical management, the final clinical outcome and vision.~      Bacterial and fungal growths from patients will also be stored for further research during a~     second phase of ACSIKS. These studies will focus on evaluating the resistance of the most~     common bacterial infections to the current available antibiotics, performing DNA testing to~     compare our strains with bacterial infections in the West, and to developing new diagnostic~     tests and anti-infective therapies tailored to corneal infections in Asia.~   "
153267|NCT01560195|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was~     independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2~     trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma~     half-life, and prolonged efficacy in compare with ﬁlgrastim. The purpose of this study is to~     determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia~     following chemotherapy in patients with advanced NSCLC.~   "
153268|NCT01560182|"~     This is a phase I/II protocol aiming at the assessment of the safety and efficacy of ARSA~     gene transfer into hematopoietic stem/progenitor cells for the treatment of Metachromatic~     Leukodystrophy.~   "
153269|NCT01560169|"~     This is an evaluation of celiac-specific patient reported outcome instruments in celiac~     disease patients.~   "
153270|NCT01560143|"~     If tigecycline clearance increases with body size then serum exposure values will be lower in~     obese class III compared to normal weight subjects because exposure changes inversely with~     clearance when the dose is fixed without regard to weight.~   "
153356|NCT01559025|"~     The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the~     prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus~     newly diagnosis ( less than 6 months).~      The secondary objectives are:~        1. To define the immune and inflammatory profile~        2. To define the secretion of glucagon and GLP-1~        3. To assess the glycemic variability~   "
153271|NCT01560130|"~     Behavioral weight loss programs can successfully reduce body weight, but these programs are~     available to limited numbers of overweight and obese individuals. This project evaluates a~     unique weight loss approach that combines a self-sustaining weight loss campaign (for~     outreach) with training in behavioral weight loss strategies and tests the efficacy of adding~     components designed to enhance accountability and increase motivation for weight loss.~   "
153272|NCT01560117|"~     Immunotherapy with the monoclonal anti-CD20 antibody rituximab has become standard of care~     for patients with follicular lymphoma. However, there are still open questions regarding~     dosing and scheduling of rituximab, optimal type of chemotherapeutic combination partners~     during induction as well as the best interval and length of rituximab maintenance treatment.~     Fludarabine-mitoxantrone combinations have shown strong debulking activity as initial therapy~     followed by rituximab maintenance. While rituximab maintenance with a standard dose of 375~     mg/m2 prolongs clinical remissions, administration schedules still vary: Three-monthly~     infusions for 2 years and two-monthly infusions for one or 2 years are most frequently used.~     A few pharmacokinetic data for rituximab have been reported for induction treatment. These~     studies have proposed a presumptive active level of 25.000 ng/ml in anti-lymphoma~     treatment. However, there is only limited information regarding maintenance treatment in~     patients who are in remission and have no remaining tumor load.~      The aim of this trial is to investigate the effect of treatment with oral Fludarabine,~     Mitoxantrone und Rituximab and Rituximab maintenance on the depth of remission measured by~     BCL2/IgH PCR.~   "
153273|NCT01560104|"~     A Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin~     and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated~     Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC).~   "
153274|NCT01560091|"~     Tamsulosin is an alpha blocker usually prescribed for urinary complaints that has been shown~     to have some benefit in allowing kidney stones to pass through the ureter. Silodosin is a new~     alpha blocker that acts more rapidly than tamsulosin and has been shown to have specific~     receptors on the ureter. The investigators would like to see if there is some benefit to~     taking silodosin over tamsulosin after extra-corporeal shock wave lithotripsy (ESWL) to break~     kidney stones in terms of allowing the ureteral fragments to pass through the ureter. Our~     hypothesis is that silodosin will be at least as effective as tamsulosin in terms of allowing~     stones to pass, but may allow them to pass more quickly because of the rapid onset of action.~      The side effect profile for both drugs is quite similar and tolerable. Patients may~     experience some common side effects associated with tamsulosin, including abnormal~     ejaculation, dizziness, rhinitis (runny nose, sneezing), and somnolence (sleepiness). Serious~     reactions include orthostatic hypotension, syncope (fainting), and priapism (prolonged~     undesired erection).~      Patients may experience some common side effects with both silodosin and tamsulosin including~     ejaculatory dysfunction, dizziness, postural hypotension, diarrhea, and headache. Serious~     side effects are rare and include orthostatic hypotension, intra-operative floppy iris~     syndrome, syncope, and priapism.~      Patients will experience the discomfort normally associated with kidney stones. All efforts~     will be made to alleviate these discomforts, including the use of the study medications.~     Patients will be able to take their routine prescribed pain medications, and will be asked to~     keep a record of their pain medication use.~      The investigators will be randomly enrolling patients from all racial backgrounds and of both~     genders. They must have kidney stones ranging in size from 4mm to 1.0 cm and have no prior~     treatment for the study.~      The primary endpoint of this study is the clearance rate of kidney stones. That is, in what~     period of time does the patient achieve clearance, is stone free and has all residual stones~     gone. The secondary endpoints of this study include analgesic use, residual stones remaining,~     need for re-treatment, need for intervention, steinstrasse clearance, and the need for~     hospitalization.~   "
153275|NCT01560078|"~     Tubercular pleural effusion is the second most common form of extrapulmonary tuberculosis~     (EPTB) seen in clinical practice after tuberculosis (TB) lymphadenitis. It is common that~     after complete treatment of the patient with tubercular pleural effusion with six months of~     the short-course chemotherapy under Directly Observed Treatment Short-Course (DOTS), pleural~     effusion has not resolved completely. In these cases treatment need to be extended for one or~     two more months by giving extension pouches.~      Since DOTS does not recommend demonstration of complete resolution of tubercular pleural~     effusion at the end of treatment completion, there is paucity of data in terms of the~     patients declared cure for the sputum negative pulmonary and extra-pulmonary TB as such which~     includes TB pleural effusion as well. This project aims to look into the patient~     characteristics, treatment outcome, and compute the number of cases which require an extended~     regimen and to what extent is the pleural effusion persistent at the end of six months of~     standard DOTS therapy.~   "
153276|NCT01560065|"~     Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates~     (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules~     is higher than in serum and it was increasing during the movement through the epididymis and~     the deferent duct. In the present study, the role of myo-inositol has been investigated as a~     possible antioxidant agent for the systemic treatment of male infertility and the improvement~     of the sperm's quality.~      Samples of seminal fluid were obtained from two groups of patients undergoing to a IVF cycle:~     healthy subjects and subjects with oligoasthenospermia (OA, < 15 mil/ml). The collected~     samples were submitted to optic microscopy in order to evaluate semen's volume, spermatozoa's~     number and motility, during the initial semen analysis and after density gradient separation~     method; these parameters were evaluated before and after the administration of 4000mg/die of~     myo-inositol associated to 400 µg of folic acid for three months.~      These values were compared with samples of seminal fluid of healthy patients undergoing to a~     IVF cycle for a female cause of infertility (control group).~   "
153277|NCT01560052|"~     This study will evaluate the long-term efficacy and safety of low dose oral~     methylprednisolone compared to matching placebo, on a background of routine RAS inhibitor~     therapy, in preventing kidney events in patients with IgA nephropathy and features suggesting~     a high risk of progression.~   "
153298|NCT01559779|"~     The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric~     bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as~     well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric~     procedure that changes the gastrointestinal anatomy and has been demonstrated to cause~     remission of type 2 diabetes shortly after the operation, before any significant weight loss.~     The altered transit of nutrient through the gastrointestinal tract after the operation is~     thought to play a key role in this remission and studies have shown significant changes in~     the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1).~     However it is unknown whether the secretory function of the pancreatic islets as well as the~     stimulatory effect of the incretin hormones is changes postoperatively.~   "
153357|NCT01559012|"~     CLONEMESI is an academic, independent, randomized placebo-controlled trial to assess the~     effect of transdermal (TD) clonidine in improving the symptoms of severe Hyperemesis~     Gravidarum(HG) affecting women in their 6th-12th week of pregnancy. The study has a crossover~     design.~   "
153278|NCT01560039|"~     Chronic neuropathic pain is a global health concern, affecting millions of patients~     worldwide. It is often extremely debilitating and poses a diagnostic and therapeutic~     challenge. The current mainstay of treatment is pharmacotherapy consisting of powerful~     analgesics combined with different classes of drugs that change nerve cell membrane~     properties. However, response to pharmacotherapy is often poor and mandates interventional~     strategies. Among the latest and most promising interventional strategies is the use of~     neurostimulation to targeted brain areas, specifically the primary motor cortex . Motor~     cortex stimulation , both invasive and noninvasive (using megnetic or electical stimulation),~     has emerged as a highly beneficial treatment, and is currently included in different~     professional guidelines for the treatment of medically refractory neuropathic pain.~      A possible alternative way to achieve stimulation of the motor cortex is by using EEG based~     neurofeedback. This design, which is actually a Brain Computer Interface (BCI) enables the~     patient to voluntarily modulate the activity of a circumscribed brain area after a few~     training sessions. While EEG based neurofeedfback is decades old, it has never been tested in~     neuropathic pain patients.~      This experiment is intended to compare both the clinical effects and the brain correlates of~     a BCI based self modulation of M1 activity and of exogenous magnetic brain stimulation in a~     population of patients suffering from chronic neuropathic pain of an upper limb. 15 such~     patients will receive a course of 10 daily magnetic stimulation sessions with stimulation of~     M1 as described in the literature. A further 30 patients will be divided into two groups: 15~     will perform a course of 10 real BCI neurofeedback sessions modulating motor cortex activity~     and 15 will perform a course of 10 sham neurofeedback sessions. The participants' baseline~     chronic pain levels and their response to acute painful stimuli will be clinically evaluated~     before and after the course, and for an additional 1 month. Furthermore, before and after the~     course patients will be scanned using functional MRI during rest (baseline pain levels) and~     during acute pain. These scans are performed both to describe the neural correlates of the~     analgesia induced by motor cortex magnetic stimulation , and to compare the observed networks~     to the network effect of a BCI neurofeedback modulation of motor cortex activity.~   "
153279|NCT01560026|"~     Endometrial cancer is one of the most common female malignancies in the United States, and~     has increased in incidence in Taiwan in recent decades.A recent population-based analysis~     noted that 4% of endometrial cancers occurred in women aged 40 years or younger, furthermore~     it is up to 15% in Taiwan according to the data of cancer registry. The standard treatment of~     endometrial cancer results in surgical menopause and places patients at risk for the~     long-term sequelae of estrogen deprivation. The goal of this study was to determine the~     frequency of a coexisting ovarian malignancy and to evaluate the outcome of ovarian~     preservation in women with treatment for endometrial cancer.~   "
153280|NCT01560013|"~     Alcohol dependence is a major health problem worldwide and recently in Israel and it has~     major health care costs. Cannabis dependence is also a major health issue and many cannabis~     users find it difficult to quit. Similar to dependence on heavy drugs, alcohol and~     cannabis-dependent patients find it difficult to quit drinking and smoking cannabis and they~     relapse to drinking alcohol and using cannabis during treatment. Craving for alcohol and~     cannabis and withdrawal during detoxification are major factors for relapse to drinking and~     using cannabis. The cue-exposure and priming paradigms have been used in order to induce~     craving for alcohol and cannabis in the laboratory. Several studies have delineated the brain~     mechanisms responsible for cue-induced craving for alcohol using functional Magnetic~     Resonance Imaging (fMRI), a method that can be useful in monitoring progress of treatment. A~     proven useful medication for treatment of alcohol dependence is the opiate antagonist~     naltrexone commonly used for treatment of opiate dependence. We have found that~     cannabis-dependent patients in treatment for cannabis dependence who also were heavy users of~     alcohol have dropped early from treatment.~   "
153281|NCT01560000|"~     The objective of this study is to determine the satiety value of different bran fibers on~     appetite & subsequent food intake with acute consumption. Satiety will be measured~     subjectively by visual analogue scales (VAS).~   "
153282|NCT01559987|"~     The purpose of this research study is to investigate water flow in dental devices and to~     understand the function of water flow behind oral hygiene improvements. Understanding this~     mechanism may help with the design of future products.~   "
153283|NCT01559974|"~     The purpose of this study is to determine whether the intake of Vitamin D has a positive~     effect on walking ability of patients with peripheral artery occlusive disease. Skeletal~     muscle fibers change morphology in peripheral artery occlusive disease. In patients with~     Vitamin D-deficiency there are also changes of skeletal muscle fibers. The investigators have~     the hypothesis that patients with peripheral artery occlusive disease with subsequent changes~     of muscle fibers morphology of calf muscles might take profit of the administration of~     Vitamin D in combination with training.~   "
153284|NCT01559961|"~     The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in~     women with interstitial cystitis/bladder pain syndrome.~   "
153285|NCT01559948|"~     The purpose of this randomized clinical trial is to examine the usefulness of the addition of~     a pelvic compression belt to a lumbopelvic stabilization program for patients with sacroiliac~     joint pain by comparing lumbopelvic stabilization exercises with a pelvic compression belt to~     lumbopelvic stabilization exercises alone. Outcome measures including the Modified Oswestry~     Low Back Pain Disability Index (OSW), the percentage change of TrA and IO muscle thickness~     (i.e. muscle contraction from rest to contract) utilizing ultrasound imaging, the Numeric~     Pain Rating Scale (NPRS) for pain, and a subjective rating of overall perceived improvement~     using the Global Rating of Change (GROC) scale will be collected. Hypothesis: The OSW scores~     and NPRS scores will be lower for those who receive the compression belt in addition to the~     lumbopelvic stabilization program as compared to those who receive the lumbopelvic~     stabilization alone. The percent change of muscle thickness for the deep abdominals as well~     as the GROC scores will be higher for those who receive the compression belt in addition to~     the lumbopelvic stabilization program as compared to those who receive the lumbopelvic~     stabilization alone.~   "
153286|NCT01559935|"~     The purpose of this study is to evaluate the safety and effectiveness of an investigational~     new drug called carfilzomib, in combination with dexamethasone in subjects with newly~     diagnosed multiple myeloma followed by treatment with a combination of drugs clarithromycin~     (Biaxin®), lenalidomide (Revlimid®) and dexamethasone (Decadron®) [BiRD] then lenalidomide~     alone.~   "
153287|NCT01559922|"~     The purpose of this study is to determine whether Artefill is safe and effective for the~     correction of atrophic facial acne scars.~   "
153310|NCT01559623|"~     The purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma~     urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder~     symptoms, and to correlate these findings with cystoscopic and urodynamic findings.~   "
153311|NCT01559610|"~     The purpose of this study is to determine whether the guidelines preoperative performed by a~     nurse contribute to the recovery of the patient submitted to cardiac surgery compared with~     the guidelines for routine.~   "
153358|NCT01558999|"~     The purpose of this study is to assess the safety and effectiveness of SI-614 solution~     compared with placebo solution in treating patients with dry eye~   "
153288|NCT01559909|"~     Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a~     socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb.~     VAS may improve stability, weight bearing, comfort, proprioception, limb health, and~     function. To date, there is no evidence to support whether VAS alters balance, kinematics,~     and kinetics when walking for TF amputees as compared to conventional socket suspension~     technology. Further, there is question regarding what the optimal height of the socket should~     be to maintain stability and function. So long as stability is not sacrificed, it may be~     advantageous to lower the height of the socket to allow full hip motion and improve sitting~     comfort. The purpose of this investigation is to assess if the socket height alters the~     motion of the leg and changes the way one walks when using VAS compared to conventional~     socket suspension technology. In this study, TF amputees will be fitted with a VAS socket~     that will be attached to their current prosthesis using similar alignment. Individuals will~     be assessed while walking on a level floor and during stair negotiation while wearing the~     prosthesis with the VAS socket at various socket heights as well as their current socket.~     Additionally, balance and socket standing and sitting comfort will be investigated.~   "
153289|NCT01559896|"~     The incidence of type 2 diabetes mellitus (T2DM) is rapidly growing. Patients with T2DM are~     at increased risk of developing long term micro- and macrovascular complications. Subjects~     with impaired glucose tolerance (IGT) show increased blood glucose levels after an oral~     glucose load. These subjects have a markedly increased risk of later T2DM development.~      T2DM development can be prevented or delayed by lifestyle modifications. To support lifestyle~     changes and reduce the risk of T2DM development, foods containing functional ingredients are~     being developed. An interesting functional ingredient is protein hydrolysate. An egg protein~     hydrolysate has been experimentally shown to improve endothelial function, to inhibit plasma~     angiotensin converting enzyme (ACE) and to reduce blood pressure in rats. Egg protein~     hydrolysate could thus be a interesting ingredient to treat the cardiovascular dysfunction~     associated with T2DM. In the present study, the effects of egg protein hydrolysate will be~     evaluated in subjects with overweight or moderate obesity and IGT or T2DM.~   "
153290|NCT01559883|"~     The study aims to document the flow of German patients with cancer and acute deep vein~     thrombosis from first visit to diagnosis and treatment, the applied diagnostic procedures,~     and therapy modalities.~   "
153291|NCT01559870|"~     The purpose of this study is to create a model using intra-operative modified SOFA score and~     peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit~     (CICU) for adult cardiac surgery with heart-lung machine~   "
153292|NCT01559857|"~     The purpose of this study is to see how an insulin sensitizing medication, Pioglitazone, can~     cause changes in mood in some depressed patients. Study participants receive assessment of~     their cognitive and metabolic functioning.~      If they meet criteria, they will be asked to take either Pioglitazone or a placebo for a~     90-day trial. Participants will undergo an Oral Glucose Tolerance Test to measure fasting~     insulin and glucose levels, as well as routine blood testing.~      The investigators hope to quantify the role of Pioglitazone in patients with mood disorders~     and compare the values to those previously obtained in a healthy age-matched control~     population. The investigators also hope to examine the association between IR and cognitive~     performance and clinical course of depression in patients with mood disorders.~   "
153293|NCT01559844|"~     The primary objective is to determine if the administration of a combination of sofosbuvir~     (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected adults with hepatocellular~     carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation could~     prevent post-transplant re-infection as determined by a sustained post-transplant virological~     response (HCV RNA < LLoQ) at 12 weeks post-transplant.~      Participants will enroll in the pretransplant treatment phase (24 or 48 weeks). Participants~     enrolling for 24 weeks in the pretransplant treatment phase may receive treatment for up to~     an additional 24 weeks in the pretransplant retreatment phase. Participants enrolling for 48~     weeks in the pretransplant treatment will have a second baseline at Week 24 for combined~     analysis in the pretransplant retreatment phase.~      Participants who undergo liver transplant will stop all study drug 24 hours prior to~     transplant, and enter a 48-week follow-up phase to monitor for recurrent HCV infection.~   "
153294|NCT01559831|"~     IC51-319 is a single-arm, open-label study that investigates immune responses in subjects~     undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during~     primary immunization.~   "
153295|NCT01559818|"~     Patients who were previously enrolled in Study IMM-101-001 and who provide informed consent~     will be eligible to participate in this study.~      Once eligibility is confirmed, a full medical history covering the period from their~     completion of Study IMM-101-001 to date will be taken.~      The treatment regimen with IMM-101 will be one dose given every 4 weeks or as close to this~     interval as permitted due to practical or logistic considerations. The dose interval may be~     modified at the discretion of the Investigator provided the minimum period between doses in~     no less than 14 days.~      The overall objective is to determine the long term safety profile of IMM-101 administered~     intradermally for extended use.~   "
153296|NCT01559805|"~     The study involves delivering one of two interventions - either Promoting Action Towards~     Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men~     (MSM) who have recently been diagnosed with HIV and assessing whether participants who~     received PATH achieve greater suppression of HIV viral load, demonstrate greater uptake of~     care and adherence to treatment, and engage in less sexual HIV transmission risk behavior~     than participants who received PCC.~        -  PATH consists of two preliminary sessions plus booster sessions after 1, 3, and 6~          months.~        -  Personalized Cognitive Counseling consists of one session.~      Participants will complete assessments before participating in their intervention (i.e., at~     baseline) and at 3, 6, 9, and 12 month follow-up points. Participants' viral loads will be~     measured at approximately 6 and 12 months following baseline.~   "
153297|NCT01559792|"~     The investigators want to study the changes in secretion of gastrointestinal hormones,~     absorption and metabolism of food and liquids before and after gastric bypass and in patients~     who are gastric banded but are getting conversion to a gastric bypass. All patients are with~     normal glucose tolerance. The investigators hypothesis that food uptake/absorption of food is~     faster after gastric bypass and the secretion of gastrointestinal hormones change.~   "
153299|NCT01559766|"~     Vitamin A deficiency remains a major public health problem in developing country worldwide.~     Young Children are considered to be at greatest risk of deficiency. However, there is little~     information on the vitamin A requirement of Chinese children. In the present study, about 400~     children aged between 4 and 9 years old in a kindergarten and an elementary school of Shiyan~     City were screened before admission by questionnaire and anthropometric measurement. The~     vitamin A status of children was assessed by serum vitamin A level, relative dosage reaction~     and stable-isotope dilution technique. At the same time, their dietary vitamin A intakes were~     estimated by weighted-food dietary survey. The dietary vitamin A requirement in young~     children was determined on the basis of dietary vitamin A intakes in Children with adequate~     vitamin A level.~   "
153300|NCT01559753|"~     The duration of treatment of community acquired pulmonary infection varies between 5 and 14~     days according to the authors (22), or even 3 days with new drugs having long half-life (2).~     For nosocomial pulmonary infection, treatment durations are not standardized (5). It is~     simply mentioned the concept of usual treatment of at least 15 days. However, recent~     studies used 10 days of treatment without significant decrease in the rate of healing~     compared to usual treatment. It is essential to clarify the optimal duration of antibiotic~     treatment. Indeed, any excessive extension of treatment may increase the occurrence of~     adverse effects (renal toxicities, hepatic...), and induce resistance of bacteria to~     antibiotics (selection pressure), colonization of the patient by Multiresistant bacteria and~     an increase in the cost of treatment~   "
153301|NCT01559740|"~     After undergoing hernia surgery, hydrocelectomy or lower abdominal surgery, a child may~     experience some amount of pain in the post-operative period. As part of the anesthesia~     technique, the investigators routinely provide a nerve block done on the abdominal wall that~     will provide pain relief for at least 10 hours postoperatively. This is referred to as a TAP~     block. The purpose of this study is to determine if the nerve block performed with local~     anesthetic solution using a regular concentration solution vs. a diluted solution may offer~     different durations of pain relief.~   "
153302|NCT01559727|"~     The purpose of this study is to examine the efficacy of three doses of prednisone, a~     glucocorticoid, in treatment of patients with symptomatic heart failure.~   "
153303|NCT01559714|"~     Study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical~     Hypertrophic Cardiomyopathy (HCM)) and in 2) patients with clinically overt HCM (clinical~     HCM).~      Hypothesis: Cardiac troponin release after exercise can be demonstrated in both clinical and~     pre-clinical HCM patients.~   "
153304|NCT01559701|"~     Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low~     Back Pain Or Osteoarthritis~   "
153305|NCT01559688|"~     Service members and veterans often experience symptoms of psychological trauma following~     combat deployments. While efforts are being made in the military and at the Veteran's Affairs~     to meet the large number of soldiers and veterans experiencing symptoms of psychological~     trauma, there remains a need to evaluate new treatments, particularly those that are designed~     to be brief in length.~      A new therapy, known as Accelerated Resolution Therapy (ART), is a type of psychological~     therapy that is designed for rapid resolution of symptoms of psychological trauma. This~     approach uses a combination of talking and sets of eye movements guided by the therapist.~     During therapy, this interactive personal guidance is thought to be helpful in resolving~     problems (such as bad memories).~      The purpose of this study is to:~        1. Evaluate how effective ART is in treating symptoms of psychological trauma among~          non-active duty veterans who served in Operation Iraqi Freedom and Operation Enduring~          Freedom in Iraq and in Afghanistan or other combat conflicts.~        2. Learn if there is improvement in symptoms of psychological trauma (such as bad memories,~          anxiety, depression, and guilt) after receiving Accelerated Resolution Therapy (ART).~   "
153306|NCT01559675|"~     The purpose of this study is to evaluate the effect of low dose versus high dose steroids~     vital signs of patients currently on steroids or recently treated with steroids undergoing~     major colorectal surgery. The investigators hypothesize that there will be no statistically~     significant difference in orthostatic hypotension (blood pressure measured on lying, sitting,~     and standing), blood pressure, temperature or heart rate in the standard and low dose groups.~   "
153307|NCT01559662|"~     The Purpose of this study is to evaluate the effect of gum chewing on recovery of~     gastrointestinal function in patient undergoing major colorectal surgery. The investigators~     hypothesize that patients who chew gum after major colorectal surgery will have faster~     recovery of gastrointestinal function.~   "
153308|NCT01559649|"~     Stroke is a major medical problem in the United States, and veterans are at significant risk~     given that the most critical risk factors of stroke, older age and associated medical~     problems such as high blood pressure, are common. Dysphagia, swallowing problems, can lead to~     aspiration which in turn may result increased pneumonia, particularly in stroke patients.~     Development and implementation of an accurate and consistent nursing swallowing screening~     tool to identify risk of aspiration in individuals admitted with suspected stroke is critical~     as it allows for immediate intervention, thereby reducing associated medical complications,~     length of stay, and healthcare costs. The availability of such screening tools, however, is~     limited. The primary objective of this study is to construct a reliable and valid swallowing~     screening tool to identify risk of aspiration in individuals admitted with suspected stroke.~   "
153309|NCT01559636|"~     Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have been~     eliminated since 1988, outbreaks continue to occur, and new tools are needed to accelerate~     eradication. One concern in this effort is that some populations have decreased~     immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased~     seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV)~     was recommended for use in immunization campaigns, and will likely replace tOPV in routine~     immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been~     studied.~      This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who~     reside in Nepal. The investigators conducted a prospective, interventional study that~     assessed immune response to bOPV among infants with and without diarrhea. Immune responses~     were compared among infants with and without diarrhea.~      This study will result in a better understanding of the factors that decrease the ability of~     some children to seroconvert to OPV and be protected from poliomyelitis infection.~   "
153312|NCT01559597|"~     The purpose of this study is to determine the effectiveness, safety and feasibility of a~     tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a~     controlled temperature chain (CTC). The CTC is defined as the storage and transport of~     vaccines within a temperature range appropriate to the heat stability profile of TT vaccine.~     In this study vaccines are transported and stored in the cold chain up to district level.~     From district to beneficiary level vaccines are exposed to ambient temperatures during a~     limited period of time.~      In an initial phase, the stability of 3 lots of TT vaccine kept in CTC is determined. For~     this, the potency, safety, pH and adsorption of vaccines maintained in CTC will be tested in~     the laboratory and compared to vaccines that have been maintained in cold chain. If all~     parameters (i.e. potency, safety, pH and adsorption) are above WHO specifications the~     strategy in CTC will be used.~      Only if the laboratory results are adequate, villages will be assigned to one of the~     vaccination strategies. All women between 14 to 49 years of age in the selected villages who~     fulfill the inclusion criteria will be invited to participate.~      In order to determine the baseline anti-tetanus protection, TT vaccination history will be~     collected from all participants using a standardized questionnaire. Women who have already~     received at least 2 doses of TT vaccine will be excluded from the study. Moreover, blood will~     be collected from all participants to later verify in laboratory the baseline protection.~      A first dose of TT vaccine will be given according to the assigned strategy (CTC or cold~     chain). Four weeks after the 1st vaccination, a second TT vaccine will be given using the~     same strategy employed for the first dose. Finally, four weeks after the second dose, a blood~     sample will be collected from all participants who received two doses of vaccine. The~     serological responses will be compared in the group that received two doses of TT vaccine~     maintained in cold chain ant the group that received two doses of vaccine maintained in CTC.~   "
153313|NCT01559584|"~     Alopecia areata (AA) is a disease of the hair follicles with multifactorial etiology and a~     strong component of autoimmune origin. It is characterized by non-scarring hair loss on the~     scalp or any hair-bearing surface.~      Various therapeutic agents have been described for the treatment of AA, but none are curative~     or preventive. The aim of AA treatment is to suppress the activity of the disease.~     Phototherapy in the form of topical psoralen and ultraviolet A (PUVA) has been a well~     documented therapy for AA since 1978.~      A more recent technique of topical PUVA, namely phototoxic PUVA, has been adopted in two~     previous studies. Sessions were carried out once every 3 months, and a higher efficacy with~     more encouraging response rates in comparison to the conventional PUVA therapy has been~     documented. This assumed upper hand over the conventional PUVA might be due to increasing the~     amount of UV reaching the hair follicle cells and the surrounding inflammatory cells. Also it~     has been suggested that it might play a role as a powerful initiating agent of suppression~     through direct action at the DNA level. However, still the exact effect of this treatment has~     not been fully clarified.~   "
153314|NCT01559571|"~     The purpose of this study is to determine what factors influence the visual outcomes of~     infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes.~   "
153315|NCT01559558|"~     The purpose of this study is to retrospectively review the impact of vaginal packing on the~     urodynamic studies, especially for urethral pressure profiles.~   "
153316|NCT01559545|"~     Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly~     in people who have taken potent antibiotics. When C. difficile multiplies within the colon,~     it produces two toxins that cause inflammation and resultant abdominal pain, fever and~     diarrhea. Current treatment of mild to moderate disease is with immediate release~     metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed~     a delayed release form of metronidazole to release just before the colon to increase the~     concentration of antibiotic in the colon to improve the effectiveness of metronidazole~     treatment and potentially to allow less whole body exposure to the antibiotic.~      This study will measure the amount of metronidazole in the blood and stool of patients with~     C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing~     the antibiotic as designed, immediately before the colon.~   "
153317|NCT01559532|"~     This is an observational study to analyze the influence of surgery duration and tourniquet~     time in the incidence of deep venous thrombosis (DVT) in patients that had undergone total~     knee arthroplasty (TKA).~   "
153318|NCT01559519|"~     The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post~     tips hepatic encephalopathy'~   "
153319|NCT01559506|"~     The objective of this study is to determine whether the Air Barrier System (ABS) reduces~     airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior~     spinal procedures~   "
153320|NCT01559493|"~     Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of~     coronary artery stenosis severity in routine practice~        -  To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous~          coronary intervention (PCI).~        -  To investigate the influence of hyperemia on iFR.~        -  To test reproducibility of iFR and FFR.~   "
153321|NCT01559480|"~     Endometriosis is one of the most common disease in reproductive aged women.Surgical~     intervention has a significant symptoms relief. However, symptom recurrence is often after~     surgery. This study aims to determine the efficacy of Desogestrel compared with placebo in~     pain symptom of symptomatic endometriosis patient undergo conservative surgery . The primary~     outcome measurement is pain score at 6 months after surgery.~   "
153322|NCT01559467|"~     Approximately half of patients with acute chest pain, a very common reason for emergency~     department visits worldwide, have a cardiac cause. Two-thirds of patients with a cardiac~     cause are eventually diagnosed with a so-called non-ST-elevation myocardial infarction. The~     diagnosis of non-ST-elevation myocardial infarction is based on a combination of symptoms,~     electrocardiographic changes, and increased serum cardiac specific biomarkers (high-sensitive~     troponin T). Although being very sensitive of myocardial injury, increased high-sensitive~     troponin T levels are not specific for myocardial infarction. Invasive coronary angiography~     is still the reference standard for coronary imaging in suspected non-ST-elevation myocardial~     infarction. This study investigates whether non-invasive imaging early in the diagnostic~     process (computed tomography angiography (CTA) or cardiovascular magnetic resonance imaging~     (CMR)) can prevent unnecessary invasive coronary angiography. For this, patients will be~     randomly assigned to either one of three strategies: 1) routine clinical care and computed~     tomography angiography early in the diagnostic process, 2) routine clinical care and~     cardiovascular magnetic resonance imaging early in the diagnostic process, or 3) routine~     clinical care without non-invasive imaging early in the diagnostic process.~   "
153323|NCT01559454|"~     Chronic pain patients are treated with prescription opioids and many exhibit opioid~     addiction. Currently, there are no evidence-based guidelines to better manage patients with~     chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and~     methadone treatment in these patients. The investigators hypothesize that both buprenorphine~     and methadone treatment will reduce pain and addiction behaviors and increase functioning in~     these patients.~   "
153324|NCT01559441|"~     Increased postprandial lipemia may increase the risk for cardiovascular diseases. An~     important mechanistic link between lipemia following a high-fat meal and adverse~     cardiovascular events is lipid-mediated endothelial activation. Therefore, it is important to~     identify nutrients that can neutralize this acute vascular disturbance.~      The investigators hypothesize that beetroot juice, a food rich in inorganic nitrate, could~     improve vascular activity during the postprandial phase.~   "
153325|NCT01559428|"~     Plant sterols and stanols (also called phytosterols and phytostanols) are structurally~     related to cholesterol, but absorbed to a much lesser extent. Due to this structural~     similarity, plant sterols and stanols inhibit intestinal cholesterol absorption and lower~     serum LDL cholesterol concentrations by about 10% at daily intakes of 2.5 g. Plant sterol-~     and stanol-enriched food products are therefore widely available on the market to lower the~     risk for coronary heart disease. Plant sterols can undergo oxidation, which results in the~     formation of oxyphytosterols. Animal studies have now suggested that oxyphytosterols are~     atherogenic. Although oxyphytosterols have been identified in human serum samples, the effect~     of an increased intake of plant sterols on serum oxyphytosterol concentrations in humans is~     not known. On the other hand, plant stanols cannot be oxidized and lower not only cholesterol~     absorption, but also plant sterol absorption.~      The major objective of the present study is to examine the effects of dietary plant sterols~     and stanols on fasting serum concentrations of oxyphytosterols. The minor objective is to~     investigate the effects of these products on postprandial serum oxyphytosterol~     concentrations.~   "
153326|NCT01559415|"~     Almost half of the Dutch population is currently characterized by overweight and obesity.~     Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight~     regain after weight loss: the yoyo-effect. The primary objective of this study is to~     investigate the association between the weight-loss-induced cellular stress response and the~     rate of weight regain. The secondary objective is to investigate the differences in cellular~     stress response and weight regain after rapid and slow weight loss. To investigate this,~     subjects will receive meal replacements replacing either all or part of the daily meals~     during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks~     while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week~     normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up~     period subjects will receive dietary advice according to the Dutch recommendations for~     healthy eating. The association between the amount of weight regain after the weight loss~     period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue~     metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein~     expression and gene polymorphisms in selected genes.~   "
153327|NCT01559402|"~     The study investigates if applying a special ventilatory strategy during anesthesia for~     laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of~     using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates~     oxygenation with blood gas samples but also with a new method that might give more~     information without the use of blood gas samples.~      Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction~     and maintenance of anesthesia is performed with either a continuous positive airway pressure~     (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in~     comparison to a technique without CPAP but with a PEEP of 10 cm H2O.~      Secondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative~     period if emergence from anesthesia is performed without high levels of oxygen.~   "
153328|NCT01559389|"~     Study the quality of the relationship in couples affected by Urge Urinary Incontinence (UUI)~     and identify how treatment may improve the relationship.~   "
153329|NCT01559376|"~     The objectives of the study are two-fold:~        1. To determine the mean 5 year patency rate of the radial artery graft (Open vs.~          Endoscopic) of patients who have already had CABG surgery and who previously~          participated in the centre's RCT back in 2005-2007 using CTA and MPS-MIBI~        2. To determine patient quality of life at 5 years post CABG surgery~      It is hypothesized that the mean 5 year patency rate of the radial artery graft harvested~     endoscopically will be equal to or have greater patency than the radial artery graft~     harvested via the conventional/open technique. It is further hypothesized that patient~     quality of life will be similar amongst patients having had the open vs. endoscopic radial~     artery graft during CABG surgery.~   "
153330|NCT01559363|"~     The primary objective of this study is to determine the safety, plasma pharmacokinetics, and~     maximum tolerated dose (MTD) of KD019 when administered to subjects with ADPKD.~   "
153331|NCT01559350|"~     The ideal grafts for the right coronary artery system in coronary artery bypass surgery~     remain controversial. The objective of this study is to compare the long-term patency of a~     right gastroepiploic artery and a saphenous vein graft used for revascularization of the~     right coronary artery system in off pump coronary artery bypass surgery and to analyze the~     long-term clinical outcomes.~      Total 224 patients will be enrolled according to the randomization protocol.~      Check list~        1. Laboratories~        2. Quantitative coronary analysis (preoperative)~        3. Major adverse cardiac and cerebrovascular event~        4. coronary CT (coronary angiography if needed) at discharge, 1, 5, 10 years~          postoperatively~        5. Echocardiogram~      5. Cardiac enzyme~   "
153332|NCT01559337|"~     A proper digital nerve (PDN) defect causes partial or complete sensory loss of the finger~     pulp, which results in functional disability.The dorsal branch of the PDN can be transferred~     for reconstruction of such nerve defects.In this study, the investigators modified the~     Lesavoy et al' technique and evaluated the efficacy of dorsal sensory branch transfer for PDN~     defects. For comparison, the investigators collected a consecutive series of 32 patients with~     finger PDN defects treated using a traditional sural nerve graft from February 2005 to~     October 2008.~   "
153349|NCT01559116|"~     The primary objective of the trial is to determine the 24-hour FEV1-time profile of~     tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of~     treatment.~   "
153350|NCT01559103|"~     Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients~   "
153351|NCT01559090|"~     The purpose of this study is to assess safety, tolerability, pharmacokinetics and~     pharmacodynamics of MEDI-546 in Japanese SLE patients.~   "
186566|NCT01122563|"~     This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before~     and after solifenacin treatment to OAB subjects.~   "
153333|NCT01559324|"~     ECT (electroconvulsive therapy) is mostly given to patients between the age of 60 - 85 years.~     There is limited evidence on the efficacy and cognitive side-effects of right unilateral (RU)~     and bifrontal (BF) electrode positions, the placements that are considered safe for the~     elderly. As far as the investigators know no randomized controlled trials (RCTs) have yet~     been published describing this population treated with BF or RU ECT. Non-demented depressed~     patients will be randomized to either method (n = 2x36). Symptom intensity, global cognitive~     function and biomarkers will be related to 20 healthy comparators. Testing, evaluation of~     depression and blood-tests are done before ECT-treatment, after a series of 6-16 ECT and 3~     months after terminated ECT-treatment.~   "
153334|NCT01559311|"~     The purpose of this clinical project is to evaluate the efficacy of the presence of Right~     Ventricular Apical (RVA) pacing induced ventricular dyssynchrony as a guiding parameter for~     bi-ventricular pacing in patients with bradycardia and normal left ventricular ejection~     fraction (LVEF). The results of this project may provide with the evidence based medicine for~     guidelines expansion of using Cardiac resynchronization therapy (CRT) in patients with Heart~     Block and normal LVEF (LVEF >45%).~   "
153335|NCT01559298|"~     The purpose of this study is to compare aspirin + clopidogrel with aspirin alone as~     antithrombotic treatment following transcatheter aortic valve implantation (TAVI) for the~     prevention of major ischemic events [myocardial infarction (MI), ischemic stroke] or death~     without increasing the risk of major bleeding events.~   "
153336|NCT01559285|"~     In this trial, the investigators intend to examine whether the concentration of local~     anesthetics during epidural analgesia could be modulating factor for change of hemodynamics~     in patients undergoing major upper abdominal surgery.~   "
153337|NCT01559272|"~     The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a~     paliperidone palmitate 3-month formulation in patients with schizophrenia.~   "
153338|NCT01559259|"~     This study will determine the overall analgesic efficacy of three different fixed dose~     ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.~   "
153339|NCT01559246|"~     The purpose of this study is to compare short term (up to 48 hours) traditional cardiac~     rhythm monitoring using a standard ambulatory Holter monitor versus long term (up to 14~     days), continuous ambulatory cardiac rhythm monitoring using a new device cleared by the FDA~     (Zio® Patch), iRhythm Technologies, Inc., San Francisco CA) in patients with suspected~     cardiac arrhythmias.~   "
153340|NCT01559233|"~     Patient demand for non-surgical, non-invasive, and no-downtime wrinkle and rhytides treatment~     procedures has grown dramatically over the past decade as new treatments and technologies~     have been introduced.~      This study was performed in order to evaluate the efficacy and safety of the Invasix FPlus~     System, an innovative noninvasive system intended for wrinkles and rhytides treatment.~      Subjects were treated for face wrinkles and rhytides reduction and followed for 3 months~     after last treatment. In order to evaluate treatment efficacy, pre and post treatment photos~     were introduced to three uninvolved physicians for blinded evaluation.~   "
153341|NCT01559220|"~     The purpose of this clinical study is to investigate the safety and efficacy of deep brain~     stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and~     functional disability of Alzheimer's disease.~   "
153342|NCT01559207|"~     The main objective of this study is to evaluate, for 15 healthy volunteers and for 15~     patients with a history of venous thromboembolism (VTE), the monthly variation (over 6~     months) of plasma nucleosome and free DNA concentrations.~   "
153343|NCT01559194|"~     The primary specific aim of this study was to determine if overweight and obese premenopausal~     women can lose weight and if long term weight loss impacts biomarkers associated with breast~     cancer risk.~   "
153344|NCT01559181|"~     There is an increasing trend in the society for developing obesity, type 2 diabetes and~     cardiovascular diseases. It is therefore important to identify the risk factors behind this~     tendency. Recent studies have shown that exposure to high blood sugar levels in pregnancy (as~     in mothers with type 1 diabetes) may play a role in the development of obesity, type 2~     diabetes and cardiovascular diseases later in life for the children. Some studies suggest~     that high blood sugar levels during pregnancy can also affects cognitive function as well as~     growth and development of puberty. The mechanisms behind this are not sufficiently clarified~     yet.~      In the period 1993-1999, pregnant women with type 1 diabetes in Denmark were followed and~     information about the course of pregnancy was collected, including the long-term blood sugar~     level during pregnancy and the children's' condition at birth. The unique opportunities in~     Denmark to identify and follow the children of these mothers and the possibility to select a~     comparison group of children of non-diabetic mothers gives a unique opportunity to examine~     the children of mothers with type 1 diabetes and accurately investigate the effect of blood~     sugar levels in pregnancy on conditions later in life.~      There has not previously been made any study of this size and it is the investigators hope to~     be able to quantify the effect of blood sugar level during pregnancy on outcomes later in~     life. This will potentially give the possibility to detect individuals at risk for~     cardiovascular diseases earlier and to improve prevention targets in children of mothers with~     diabetes.~   "
153345|NCT01559168|"~     The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh~     over a 12 month follow up period, using a composite outcome including a good anatomical~     correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge)~     symptoms (answer no at question 3 of the PFDI-20) and no reintervention for recurrent~     prolapse of the anterior or apical compartment.~   "
153346|NCT01559155|"~     The primary objective of this study is to describe and compare plasmatic anti-proteasome~     auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous~     pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an~     elderly control group.~   "
153347|NCT01559142|"~     The aim of the study is confirmation of efficacy of induction therapy with three doses of~     infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and~     safety of two regiment of maintenance therapy:~        1. Infliximab with immunomodulation~        2. Infliximab alone~   "
153348|NCT01559129|"~     The purpose of this first study is to evaluate the safety, tolerability, pharmacokinetics,~     pharmacodynamics and efficacy of pomalidomide (CC-4047) in the treatment of subjects with~     systemic sclerosis with interstitial lung disease.~   "
153359|NCT01558986|"~     This is a randomized, double blinded, placebo-controlled trial on the routine use of~     preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy~     of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI)~     in patients undergoing modified radical mastectomy (MRM) for breast care.~   "
153360|NCT01558973|"~     The purpose of this study is to explore whether frontal brain activation in response to~     stress varies as a function of the presence or extent of early trauma and whether or not this~     effect is greater in women compared to men. To examine the effect of stress on thinking and~     remembering. To examine the separate and interactive effects of stress, addiction,~     withdrawal, and genetics; and to examine fMRI brain activation associated with stressful,~     reward-related-cue and neutral/relaxing audiotaped scripts,visual images and emotional video~     clips in addicted individuals and in healthy controls.~   "
153361|NCT01558960|"~     Retinoblastoma treatment has become more and more focused in the last years. New treatments~     developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials.~      Intra-arterial chemotherapy with Melphalan has shown success in some patients but with~     limited response when there is marked vitreal seeding. For these cases Intravitreal~     injections of Melphalan have been successful in Japan.~      In this study the same chemotherapy (melphalan) will be administered intravitreally (directly~     through the eye wall) and the response (short and long term) will be monitored.~   "
153362|NCT01558947|"~     The purpose of this study is to evaluate the safety and the effect of perioperative~     chemotherapy in the treatment of advanced gastric cancer.~   "
153363|NCT01558934|"~     The primary objective of this study is to assess QTc (an interval of the heart rhythm)~     interaction effects between lofexidine and methadone. The secondary objectives of the study~     are to evaluate the safety and tolerability of lofexidine by evaluating and monitoring~     pharmacokinetics (amounts of drug in the blood), vital signs (heart rate and blood pressure)~     and adverse events (side effects) when co-administered with methadone; and to describe~     effects on opiate withdrawal when lofexidine is introduced following a 50% or 100% methadone~     dose reduction, as required to elicit a withdrawal response. The investigators hypothesize~     that while both agents are known to prolong the QTc interval, the combination of the drugs~     will not create an additive effect which creates a significant safety concern. The~     investigators further hypothesize that subjects will be able to tolerate the therapeutic dose~     of lofexidine (0.8 mg four times daily) when the methadone maintenance dose is lowered to~     elicit withdrawal.~   "
153364|NCT01558921|"~     Currently the 3-year disease free survival of patients with locally advanced rectal cancer is~     about 50%. Current standard treatment for patients at high risk of failing locally and/or~     systemically includes pre-operative long course radiotherapy (5 weeks) in combination with~     chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy has~     been demonstrated to improve local control, but had no effect on the overall survival.~     Different studies in patients with rectal cancer studying the effect of adjuvant post~     operative chemotherapy did not result in an improved survival. This may be due the fact that~     rectal cancer surgery (TME) is associated with a high complication rate so substantial~     proportion of patients cannot receive chemotherapy postoperatively. An alternative approach~     is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor~     short-course radiotherapy (5 days) is given, as different studies showed local control of the~     tumor for a long time. During this waiting period the patient is in a good condition to~     receive an optimal dose of chemotherapy. The investigators hypothesize that with this~     proposed protocol both the local tumour and possible micrometastases are effectively treated~     and that this will result in an increased survival. The investigators will compare this with~     the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional~     adjuvant chemotherapy.~   "
153365|NCT01558908|"~     This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial~     Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible~     for surgical or catheter-based interventions. Three doses of ERC will be examined. The~     hypothesis is that ERC administration will be well-tolerated and possibly induce a~     therapeutic benefit.~   "
153366|NCT01558895|"~     The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat~     treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of~     the efficacy includes the ascites pressure, portal vein velocity，SAAG before and after the~     treatment. Clinical symptoms were also observed simultaneously.~   "
153367|NCT01558882|"~     The mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo~     implantation. They are at the origin of the local secretion of cytokines, growth factors,~     chemokines affecting vascular development and the local immunotrophisme for the conceptus.~     The main objective of this study is to evaluate the expression of endometrial uNK cells~     before and after tubal obstruction by Essure devices. Endoluminal and endometrial levels of~     various cytokines and growth factors will also be studied.~   "
153368|NCT01558869|"~     This is an open-label, single centre, single-arm phase II study which aims to assess the~     efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan~     (Xeloxiri regimen) in treating patients with advanced unresectable pancreatic carcinoma.~     Clinical data from patients diagnosed with pancreatic adenocarcinoma will be collected and~     analyzed in this study. The patients' data will be collected and maintained in the Division~     of Medical Oncology of the University Department of Medicine, Queen Mary Hospital, Hong Kong.~   "
153369|NCT01558856|"~     The primary objective of this study is to compare the efficacy of unilateral and bilateral~     neuromodulation tests at 1 month.~   "
153370|NCT01558843|"~     This multicenter, observational, study will enroll severe neurologically injured patients~     both prospectively and retrospectively. The aims are to identify the percent of neurocritical~     care patients with sodium levels ≤ 135 mEq/L, describe treatment strategies employed,~     determine the correlation of clinical factors (i.e. GCS, ICP) with serum sodium~     concentrations in patients prior to sodium altering therapy, and evaluate outcomes through~     evaluation of length of stay, discharge disposition, and modified Rankin score (mRS).~   "
153415|NCT01558245|"~     The study aims to determine whether tissue kallikrein (TK) is efficacy for preventing the~     long-term in-stent restenosis (ISR) after stenting of symptomatic atherosclerotic stenosis of~     the middle cerebral artery (MCA) M1 segment~   "
153371|NCT01558830|"~     Ranolazine is an effective and remarkably safe agent for the treatment of patients with~     chronic stable angina, but its inhibition of voltage gated potassium channels and~     electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question~     its safety when combined with antiarrhythmic drugs. The investigators have proposed a study~     to determine the safety of ranolazine in patients with chronic stable angina who also take~     amiodarone. And are conducting a prospective single-center randomized single-blinded placebo~     controlled trial to run out of our large cardiology practice setting at Cardiovascular~     Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular~     arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia~     episodes on serial holter monitor and other serially acquired recordings (such as~     electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data)~     over a three month trial period.~   "
153372|NCT01558817|"~     Outcomes after in-hospital cardiopulmonary resuscitation (CPR) are very poor, particularly in~     patients with oxygen dependent chronic obstructive pulmonary disease (COPD) or metastatic~     cancer. Recent work found that in-hospital CPR is being performed more often before death~     with unchanging survival and that fewer CPR survivors are being discharged home, thus~     suggesting that CPR is increasingly performed without benefit and that the burden of this~     ineffective treatment is increasing. Unlike other medical procedures, CPR has become the~     default provided to all patients even those with tremendously poor outcomes. It is time to~     change the paradigm of CPR. Through comparing an innovative informed assent approach toward~     in-hospital CPR (informing patients that their underlying chronic illness makes outcomes of~     CPR so poor that CPR is not performed while allowing them to disagree) versus usual care in a~     group of chronically ill patients with reduced life expectancy, the investigators aspire to~     demonstrate that CPR delivery can be reduced. And in addition that DNR status increases,~     while preserving patient quality of life and decreasing the burden of this ineffective~     treatment to both patients and families. If effective, this informed assent intervention has~     the potential to revolutionize how the investigators discuss CPR with the investigators~     chronically ill patients.~   "
153373|NCT01558804|"~     The purpose of the research is to help understand why some children become carriers of strep~     and whether children who are carriers need to be treated with antibiotics.~   "
153374|NCT01558791|"~     This research study is designed to learn about Veterans' understanding of mild TBI (traumatic~     brain injury) and the VA TBI screening process. All OEF/OIF Veterans who come to one of the~     study-related clinics for TBI screening will be invited to participate. An educational~     handout on TBI will be given to half of the participants along with their TBI screening. The~     other half of the participants will have the usual TBI screening without the educational~     handout.~      Veterans enrolled in the study will be asked to answer a 5-10 minute research questionnaire.~     The questionnaire will ask:~        -  About the individual: such as gender and branch of service~        -  About what happened during the TBI screening: such as whether the Veteran had a chance~          to ask the provider any questions~        -  About the Veteran's understanding of mild TBI: such as whether symptoms of mild TBI are~          long lasting~      Veterans who receive the educational handout will be asked specific questions about the~     handout and its information.~   "
153375|NCT01558778|"~     This pilot clinical trial studies mechanical stimulation in preventing bone density loss in~     patients undergoing donor stem cell transplant. Mechanical stimulation may limit, prevent, or~     reverse bone loss, increase muscle and cardiac performance, and improve overall health~   "
153376|NCT01558765|"~     The aim of the study is to investigate the effect of an integrated rehabilitation programme,~     consisting of physical exercise training and psycho-educational consultations, for patients~     after heart valve surgery.~      The hypothesis is that integrated rehabilitation can improve physical capacity measured by~     V02 peak, self-rated mental health and life quality by validated questionnaires such as~     SF-36, and other objective parameters such as cardiac-specific biomarkers and~     echocardiographic measurements.~   "
153377|NCT01558752|"~     The main goal is to prospectively evaluate bone mineral density adjacent to the femoral~     component and femoral bone remodeling of two different designs: CORAIL impaction broach~     titanium stem compared to a modular titanium femoral stem (Tri-lock). Patients will be~     randomized to one of the two treatment groups prior to surgery. Each patient will be~     evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following~     surgery. Patients will be asked to have bilateral DEXA bone mineral density tests (10-14 days~     post-surgery, and 6, 12 and 24 months post-operatively). Urine and serum samples (measures of~     bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight~     fast. Patient reported questionnaires will be completed preoperatively and at the 3, 6, 12,~     and 24 month visits.~   "
153378|NCT01558739|"~     The primary objective of this study is to evaluate the efficacy of INC424 in patients with~     PMF, PPV MF, or PET-MF using a composite measure of either an objective endpoint (> 50%~     reduction in splenomegaly using palpitation at 48 weeks) and/or a subjective endpoint (>50%~     reduction in total symptom score at 48 weeks).~   "
153379|NCT01558726|"~     The purpose of this study is to evaluate the effectiveness of a Case Management (CM)~     intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs (CAPSad)~     by trained social workers, in comparison to CAPSad conventional treatment on 30 and 90 days,~     considering the following outcomes: treatment retention, abstinence and changes in severity~     scores of the sixth version of Addiction Severity Index (ASI6) scale. The study hypothesis~     are: 1) The CM is going to improve the retention of crack users (cases) during the 3-month~     follow-up compared with usual care (controls); 2)Individuals who received the intervention~     with GC are going to present a higher rate of abstinence; 3)The summary scores of the ASI6~     will be significantly lower in cases than in controls, at the end of 3 months follow-up.~   "
153380|NCT01558713|"~     Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine~     with addition of fentanyl for c-section either combined or not with administration of 10 ml~     of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile,~     haemodynamics and side effects were assessed.~   "
153381|NCT01558700|"~     This study aims to determine in people with knee Osteoarthritis (OA) if relief of pain after~     treatment with either duloxetine or placebo is associated with changes in brain anatomy.~   "
153382|NCT01558687|"~     The main purpose of this clinical trial is to find out if cilengitide has an effect on brain~     tumor cells but also particularly on the blood vessels supplying the tumor with nutrient and~     oxygen in patients newly diagnosed with non-resectable (inoperable) glioblastoma.~      In addition, this clinical trial will investigate if the addition of cilengitide in~     combination with standard treatment prolongs life in patients with non-resectable~     glioblastoma. Similarly, the duration of response of the cancer to this treatment and the~     side effects of the therapy will be analyzed. Furthermore, additional data on how the body~     deals with this substance will be collected (this is called pharmacokinetics or~     pharmacokinetic (PK) analysis). In this clinical trial the investigators would also like to~     learn more about the disease and the response to the experimental medication by measuring~     certain markers.~      This imaging trial will investigate the biological effects of cilengitide monotherapy on the~     tumor microvascular function and tumor viability in a homogenous non-pretreated subject~     population with newly diagnosed Gliobastoma (GBM). The purpose of this clinical trial is to~     study the effect that cilengitide may have on certain markers of cancer in your tumor and/or~     blood and to learn if there are any disease-related markers that could help in predicting how~     subjects respond to the administration of cilengitide.~      The investigators anticipate that approximately 30 subjects will participate in this clinical~     trial. The clinical trial will be conducted in approximately 4 medical centers in the~     following countries: Germany, Poland, and Switzerland. The investigators anticipate the~     clinical trial will last until the end of 2013. Your participation in the trial may last up~     to 86 weeks.~   "
153383|NCT01558674|"~     Part I is a 3-period, active comparator-controlled, fixed sequence study to evaluate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of MK-7145 compared to furosemide~     in participants with moderate-to-severe renal insufficiency (RI) without heart failure (HF).~     Primary hypothesis for Part I is that at least one well-tolerated dose of MK-7145 will~     produce a greater 24hr urinary excretion of sodium (UNa) on the 1st day of MK-7145 dosing~     than 80 mg furosemide (on the 1st day of furosemide dosing) in participants with~     moderate-to-severe RI. If MK-7145 is safe at natriuretic doses in RI in Part I of this study,~     MK-7145 will be investigated in participants with heart failure (HF) and RI (Part II).~      Part II is 4 period, fixed sequence, active comparator controlled (in Period 1), titration~     (in Periods 2, 3 and 4) study to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of a titration regimen of MK-7145 compared to an optimized stable~     maintenance regimen of furosemide or torsemide in participants with New York Heart~     Association (NYHA) Class II and III heart failure and moderate or severe renal insufficiency.~     The primary hypothesis for Part II is that at least one dose of MK-7145, titrated according~     to a fixed dose titration regimen, will be associated with a reduction in N-terminal~     pro-brain natriuretic peptide (NT-proBNP) compared to furosemide or torsemide (at 24 hours~     post morning dose on the last dosing day of each period) in participants with NYHA class~     II/III HF with moderate or severe RI.~   "
153384|NCT01558661|"~     The purpose of this study is to find out what effects, good and/or bad, a new treatment~     called axitinib has on the patient and adenoid cystic carcinoma. This type of cancer study is~     called a phase II study.~      Axitinib is an oral medication that can interfere with cancer cell growth and reduce the~     growth of blood vessels around tumors. This study will help find out if axitinib is a useful~     drug for treating patients with adenoid cystic carcinomas. Axitinib is an experimental drug~     that has not yet been approved by the Food and Drug Administration for use in adenoid cystic~     carcinoma.~   "
153385|NCT01558648|"~     The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's~     quality of life over time. The investigators hope this study will provide important~     information that can be used to improve the quality of life of patients with esophageal~     cancer. This study will also look at how standard tests and information collected from the~     patients difficulty swallowing can predict the extent of their esophageal cancer before~     surgery.~   "
153386|NCT01558635|"~     Studies have shown that taking drugs to stay out of AF has limited success. This research is~     designed to study heart rhythm after surgical therapy, namely by measuring if there are~     benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex~     Surgical Ablation System. The system is approved and commercially available with CE mark. The~     purpose of this study is to support evidence that the Cardioblate System is safe and~     effective to treat AF.~   "
153387|NCT01558622|"~     The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol,~     tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen~     fundoplication.~   "
153388|NCT01558596|"~     The investigators have previously shown that elective vascular surgery is a high-risk~     operation with an anticipated risk of either death or heart attack of 15%. This study is~     testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior~     to the operation is safe, feasible and reduces the incidence of an adverse, perioperative~     cardiac complication.~   "
153389|NCT01558583|"~     Participants will be recruited from the United States and Australia to take an online survey~     about colon cancer screening or prostate cancer screening. Individuals selected for both the~     prostate cancer survey and the colon cancer study will be randomized to take one of three~     survey types - balance sheet, rating and ranking or conjoint analysis. These surveys will~     help participants clarify their values and opinions about screening options for colon cancer~     or prostate cancer. Participants' responses to the online survey are measured at one point in~     time - the time at which the participant takes the survey.~   "
153390|NCT01558570|"~     The purpose of this protocol is to collect serum zonulin levels in people with schizophrenia.~     This one time visit will collect zonulin levels, antibodies to gliadin (tissue~     transglutaminase and antigliadin antibodies) and other information that may relate to~     increased intracellular tight junction permeability as it related to the immune and stress~     system and the immune association with kynurenic acid pathway 50. Data will be collected for~     use in future grant applications and published reports.~   "
153416|NCT01558232|"~     The objective of this clinical study is to examine acute changes in stability, force~     allocation, work, and mobility from using a wearable, portable, battery-operated robotic~     orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity~     physical therapy.~   "
161212|NCT01455857|"~     Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior~     to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.~   "
153391|NCT01558557|"~     Background: Celiac disease is an immune-mediated reaction to gluten, presenting with~     diarrhea, weight loss, abdominal complaints and a range of less common associated neurologic~     and psychiatric symptoms. Evidence of a link between schizophrenia and celiac disease dates~     back to 1961. Recent evidence shows that 5.5% (age adjusted) of persons with schizophrenia~     participating in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)~     study had a level of antibodies to tTG that is consistent with a diagnosis of celiac disease~     (compared to 1.1% of the comparison sample). An unexpected finding was that 23.4% (age~     adjusted) of the CATIE sample had antibodies to gliadin (compared to 2.9% of the comparison~     sample). It is hypothesized that a gluten free diet in people with schizophrenia who have~     Celiac disease or gluten sensitivity will have improvement in symptoms and quality of life.~      Objectives: The aim of this proposed pilot study is to establish the feasibility of a~     initiating and maintaining a Gluten-free diet in these two groups. For this study The~     investigators will identify 8 individuals who have positive assays to tTG antibodies and~     confirmed celiac disease (N=4), or positive assays for anti-gliadin antibodies (N=4). The~     investigators plan to consent at least 2 subjects from each group and ask them to participate~     in a two-week open label treatment of a gluten free diet. The groups are;~        1. Celiac disease (positive tTG antibody); and~        2. Positive assay on Antigliadin antibodies~   "
153392|NCT01558544|"~     The study hopes to contribute to the development of technologies of ovarian tissue~     freezing-thawing and in vitro maturation of immature eggs such that a person at risk for~     premature ovarian failure might be able to conceive a genetically related child.~   "
153393|NCT01558531|"~     The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty~     followed versus conventional balloon angioplasty in superficial femoral artery and popliteal~     artery re-stenosis.~   "
153394|NCT01558518|"~     Transthoracic echocardiography (TTE) represents an established and fundamental tool for the~     evaluation of patients with known or suspected cardiovascular disease. Recently,~     manufacturers have developed handheld echocardiograms small enough to fit in the pocket of a~     physician's lab coat. Studies assessing these handheld devices have several limitations.~     While they have generally evaluated the handheld devices favorably, previous studies has not~     consistently studied handheld devices under the best possible clinical conditions and have~     not necessarily highlighted the devices' limitations.~      In this proposal, we seek to analyze the applicability of handheld echocardiograms to~     standard clinical practice. The investigators plan to use trained sonographers to perform~     handheld examinations on patients referred for TTE without established cardiovascular~     disease. The handheld images will be interpreted by experienced, consultant-level~     echocardiographers. The investigators then plan to compare findings from the handheld~     echocardiogram to the patient's standard clinical TTE.~   "
153395|NCT01558505|"~     Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral~     intervention (PTA). The aim of the study is to investigate in a randomized fashion the~     efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia,~     Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in~     diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK)~     vessels.~   "
153396|NCT01558492|"~     The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel~     and correlate response to study treatment with biologic parameters (i.e. lab studies of~     blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into~     the underlying biology of prostate tumor progression and perhaps predict which patients may~     benefit from this chemotherapy regimen.~   "
153397|NCT01558479|"~     The Parkinson's Genetic Research Study (PaGeR), headed by Dr. Cyrus Zabetian, is searching~     for genes that increase the risk of developing Parkinson's disease (PD) and related~     disorders. The study is a joint effort by neurologists and researchers across the United~     States and is sponsored by the National Institutes of Health. The coordinating center for~     PaGeR is located at the University of Washington and the VA Puget Sound Health Care System in~     Seattle.~   "
153398|NCT01558466|"~     This study hopes to evaluate the effectiveness of early combined use of Sildenafil and nitric~     oxide (iNO) in newborns with Persistent pulmonary hypertension (PPHN) and or hypoxemic~     respiratory failure and assess whether this would improve oxygenation, improve time on~     mechanical ventilation for these babies and also prevent rebound hypoxic episodes.~   "
153399|NCT01558453|"~     The purpose of this study is to determine the pediatric neoplastic response to chemotherapy~     proposed and evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1~     expression analysis.~   "
153400|NCT01558440|"~     Hypothesis:~      During rehabilitation phase of management of severe acute malnourished Bangladeshi infants~     less than 6 months old, rates of weight gain will be significantly more in children fed F-100~     and diluted F-100 compared to those fed infant formula.~      Brief summary:~      Until recently, severe malnutrition has been relatively rare in infants younger than 6~     months, but with urbanization and the HIV/AIDS pandemic it is feared that the incidence of~     severe malnutrition among young infants will rise. The question of how best to feed infants~     aged <6 months has thus come to the forefront. Given the lack of published evidence regarding~     the most advantageous formulations for feeding severely malnourished infants aged <6 months,~     there is a need for observational studies and comparative randomized trials of alternative~     formulations to guide decisions about optimum dietary management in this age group. This area~     has been aptly considered a research priority during the consultation meeting of experts from~     all over the world convened by the World Health Organization on management of severe~     malnutrition in September 2004.~      In the WHO case-management guidelines for severe malnutrition, there is no separate provision~     for young infants (infants less than 6 months old). The guidelines suggest the use of a~     low-solute formula (F-75) and continued breastfeeding in the initial stabilisation phase. In~     the rehabilitation phase, the guidelines advise F-100 with an energy density of 100kcal/100ml~     to promote catch-up growth. There is a concern that the renal solute load from using F-100 is~     too high for young infants, and some groups have started using diluted F-100 with an energy~     density of 75 kcal/100 ml.~      Another related issue is the contribution of breastfeeding in dietary intakes during~     rehabilitation. In severely malnourished infants, breast milk intakes are likely to be low~     initially when appetite is poor, but may be substantial as the infant recovers. Uncertainty~     about breast milk intakes has led to conflicting opinions and advice, weaning from the breast~     as it is not providing sufficient energy (1).~      The aim of this study, to be conducted in a carefully supervised Nutrition Rehabilitation~     Unit (NRU), will compare three recovery diets (Infant formula, F-100 and diluted F-100) in~     order to provide the evidence-base to determine if a change or add-on in terms of diet in the~     WHO guidelines is needed. It will also measure the potential renal solute load (mosmol/l),~     serum electrolytes and plasma osmolality of the same children. Body composition of the~     infants will also be measured using stable isotope dilution technique before and after the~     intervention diet is provided.~   "
153417|NCT01558219|"~     This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of~     metastatic castration resistant prostate cancer (mCRPC) patients previously treated with~     docetaxel containing regimen. The primary endpoint is safety. Secondary endpoints include~     time to treatment failure, response rate, overall survival and quality of life.~   "
153401|NCT01558427|"~     Prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are~     conventionally treated with androgen deprivation therapy. However, in patients with limited~     metastatic load, the time to progression might be. Subsequently, active surveillance of these~     patients until progression might defer the start of androgen deprivation therapy (ADT) for~     several months to years. As an alternative, salvage treatment of the limited number of~     metastases with either surgery or radiotherapy might postpone the start of ADT even longer.~     The current trial hypothesizes that ADT might be deferred longer following salvage treatment~     as compared to active surveillance.~   "
153402|NCT01558414|"~     Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study~     will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a~     transumbilical single site incision will be performed with two different manners: single-port~     device SILS TM (Single Incision Laparoscopic Surgery), and flexible endoscope and accessory~     trocars in a single incision (FSIS-Flexible Single Incision Surgery). The third group is the~     control one, a conventional laparoscopic approach.~      The trial is designed as a pilot study to assess, as main objective, if these two endoscopic~     approaches have the same security and effectiveness in cholecystectomy.~      Hypothesis:~      Transumbilical approaches with single port and single incision with the flexible endoscope~     have the same efficacy and safety performing the endoscopic cholecystectomy.~      Objectives:~      Main objective:~      Assess whether both approaches are equally safe in its application to endoscopic~     cholecystectomy.~      Secondary objectives:~      Investigate the differences in the rate of conversion to open surgery between different~     surgical approaches.~      Investigate the differences in the rate of wound infection between the different surgical~     approaches.~      Investigate the differences in the rate of postoperative incisional hernias between different~     surgical approaches.~      Investigate whether there are differences in the rate of overall complications, all-cause~     mortality and the cost between different surgical approaches.~   "
153403|NCT01558401|"~     The purpose of this study was to identify the effects and the efficiency of an adapted~     physical activity program as regards the physical condition of older Brazilian women.~   "
153404|NCT01558388|"~     Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of~     Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic~     bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased~     risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial~     vaginosis has been reported in 10-70% of cases. This study aims to verify if administration~     of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of~     bacterial vaginosis during pregnancy.~   "
153405|NCT01558375|"~     Aim of this double-blind, randomized, controlled clinical trial is to compare the safety and~     the efficacy of anakinra over placebo for the management of patients with hidradenitis~     suppurativa (HS) of Hurley II and Hurley III disease stage. Patients will be evaluated on~     subsequent follow-up visits. Two scores will be applied: disease activity as assessed in the~     protocol by the investigator; and Sartorius score. Primary efficacy endpoint will be the~     comparisons of visual analogue scores, of disease activity, of Sartorius score and of~     dermatology life quality index between the two groups of treatment over follow-up.~   "
153406|NCT01558362|"~     The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient~     management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian~     Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute.~     Initial testing results in rats and pigs suggest that in addition to being a~     cyclotron-produced alternative to 99mTc tracers, I-123-CMICE-013 may be a superior tracer for~     measuring myocardial perfusion.This Phase 1 study will study the safety and tolerability,~     biodistribution, pharmacokinetics and radiation dosimetry, and distribution and localization~     of I123-CMICE-013in healthy adult volunteers.~   "
153407|NCT01558349|"~     The main objective of this study is to compare results for the detection of circulating~     melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques~     between a group of patients with metastatic melanoma and a group of hospitalized control~     patients.~   "
153408|NCT01558336|"~     The purpose of this study is to evaluate the impact of praziquantel for the treatment of~     Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan.~   "
153409|NCT01558323|"~     This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of~     renal impairment to healthy subjects~   "
153410|NCT01558310|"~     This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous~     injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose~     of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of~     scalp psoriasis by determining the proportion of subjects who clear or almost clear in scalp~     specific physician assessments. The study will include approximately 30 subjects.~   "
153411|NCT01558297|"~     This study will test the effectiveness of two distinct treatments for weight loss:~        1. Motivational Interviewing~        2. Nutritional Counseling. These treatments will be compared to Treatment as Usual.~          Participants will be recruited through local primary care offices.~   "
153412|NCT01558284|"~     Placebo controlled double-blind study with 40 patients who have an diarrhea-predominant IBS,~     20 get Neu-P11, 20 get a placebo. Neu-P11 is a, Melatonin receptor-, Serotonin 5-HT- 1A and~     5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist.~   "
153413|NCT01558271|"~     The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in~     participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.~   "
153414|NCT01558258|"~     Younger women with breast cancer experience substantially greater distress and depressive~     symptoms than older women. These symptoms can hamper recovery and healthy behaviors that can~     reduce the risk of recurrence and/or other chronic diseases. The primary objective of this~     study is to evaluate the feasibility and preliminary efficacy of a mindfulness~     meditation-based intervention for this at-risk group of women. The investigators hypothesize~     that a structured program of mindfulness meditation will lead to significant improvements in~     psychological well-being (i.e., depression, stress), with corresponding improvements in~     health behaviors and biomarkers of cancer risk, in women diagnosed with breast cancer, prior~     to age 50. The investigators will also examine mechanisms for intervention effects, including~     increased mindfulness and ability to relax.~   "
153418|NCT01558206|"~     In this study the investigators compare the diagnostic validity of Bedside Ultrasonography of~     chest and Pulmonary artery CT Angiography in the patients who came to Emergency Department of~     Alzahra General Hospital from 1 may 2012 to 1 October 2012 with respiratory symptoms and~     signs in favor of Pulmonary Thromboemboli (PTE).~   "
153419|NCT01558193|"~     There is a series of well designed studies that have reported, in those with a history of~     anti-social behavior, that supplementation with vitamins / minerals, omega-3 fatty acids (n-3~     FA), or both, reduces the incidence of aggressive behavior. Although there is evidence that~     all these nutrients have a role, to date the relative contribution of fatty acids and~     vitamins / minerals has not been considered: for example the possibility of a synergistic~     interaction has not yet been examined. In addition the topic has to date been studied under~     real-life condition, such as a prison, making the topic difficult to study. The major aim of~     the present study was to develop a paradigm that would allow the study of the topic in a~     sample from the general population without a history of anti-social behavior. Subjects~     received either a vitamin/mineral supplement, a fatty acid supplement, both or neither for~     three months, Measures of impulsivity and aggression were assessed before and after~     supplementation. Although in the past measures of actual behaviour have proved to be~     sensitive to supplementation, questionnaire measures have not. The second major objective was~     therefore to consider whether such phenomena can be studied in a sample without a history of~     anti-social behavior, using standardized, sensitive laboratory based measures and to compare~     these with questionnaire measures.~      POLYMORPHISMS AND THE RESPONSE TO MICRO-NUTRIENT SUPPLLMENTATION The data set were~     subsequently used to test an a priori hypothesis not related to the initial hypothesis. A~     meta-analysis found a consistent pattern that micro-nutrient supplementation improved mood~     (Long SJ, Benton D. Effects of vitamin and mineral supplementation on stress, mild~     psychiatric symptoms, and mood in nonclinical samples: a meta-analysis. Psychosom Med 2013;~     75: 144-153). To produce evidence of possible mechanisms the extent was determined, to which~     the impact of micro-nutrient supplementation was influenced by a range of polymorphisms~     associated with neurotransmitter systems known to modulate mood.~      The primary outcome measure was the General Health Questionnaire, a 30-item self-report~     questionnaire that was developed to detect, in a community sample, those who would benefit~     from seeing a psychiatrist.~      Given the literature that relates polymorphisms to mood disorders, and the known pharmacology~     of anti-depressant drugs, a range of polymorphisms were chosen associated with serotonin and~     catecholamines.~      Dopamine The SNPs associated with the metabolism and functioning of dopamine were: Dopamine~     beta hydroxylase (DBH, rs16111115); Dopamine transporter (DAT1, rs2550946);~     Catechol-O-methyltransferase (COMT, rs4680, rs6269). Dopamine receptor D1 (DRD1, rs4532);~     Dopamine receptor D2 (DRD2, rs1079598, rs1800497); Dopamine receptor D3 (DRD3, rs6280);~     Dopamine receptor D4 (DRD4, rs1800955).~      Serotonin Ten SNPs associated with different aspects of serotonin metabolism were also~     considered. Rs1843809 is a SNP of the TPH2 gene that encodes Tryptophan hydroxylase.~     Rs1050565 is a SNP in the BLMH gene that influences the activity of 5HTT (SLC6A4), the~     serotonin transporter. SNPs associated with various serotonin receptors were also examined:~     genetic variations of the HTR1A gene (5-HT1A receptor, rs6295); HTR1B gene (5-HT1B receptor,~     rs6296); HTR2A gene (5-HT2A receptor, rs6311); HTR2B gene (5-HT2B receptor, rs1549339); HTR2C~     gene (5-hydroxytryptamine receptor 2C, rs518147); HTR3A gene (5-hydroxytryptamine receptor~     3A, rs1150226); HTR3B (5-HT3B receptor, rs1672717); HTR4 gene (5-HT4 receptor, rs2278392).~      Adrenergic mechanisms Finally six SNPs associated with adrenergic receptors were considered:~     ADRA2A (adrenoceptor alpha 2A, rs553668); ADRB1 (adrenoceptor alpha B1, rs1801253); ADRB2~     (adrenoceptor alpha B2, rs1042713; ADRB3 (adrenoceptor alpha B3, rs4994); SLC6AC~     (noradrenaline transporter, rs5569 and rs2242447).~      Analysis The data will be analyzed using analysis of variance with a change in GHQ from~     before to after supplementation as the dependent variable: Micronutrient/placebo X~     Polymorphism.~   "
153420|NCT01558180|"~     The investigators will conduct a randomized controlled trial comparing a telephone based~     intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series~     of phone calls to assist caregivers in learning and modifying behavioral strategies that may~     help young children with autism to sleep better. Objective (activity monitors) and subjective~     (rating scales) data will be collected by an independent research assistant at the end of the~     project. The investigators hypothesize that TCM improves sleep duration and decreases sleep~     problems relative to a usual care control condition (UC).~   "
153421|NCT01558167|"~     This is a prospective, multicenter, open label, non-randomized, phase I/II-study to define~     safety and efficacy of BRL combination in relapsed/refractory patients and to recommend a~     safe and efficacious dose for future phase II/III study.~      Hypothesis: The simultaneous administration of BRL in relapsed CLL is feasible, safe and~     efficient.~   "
153422|NCT01558154|"~     Comparison of different assessment methods to evaluate the treatment efficacy of Chinese~     medicine on minor and mild depression.~   "
153423|NCT01558141|"~     Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy,~     which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm~     insemination, embryo culture and embryo transfer.~      The oocytes are removed during surgery by aspirating the follicles using a single lumen~     needle with an ultrasound to guide the procedure. There is some data that flushing the~     follicles with embryo culture media before aspiration using a double lumen needle increases~     the number of oocytes retrieved, particularly among poor responding patients for whom each~     additional oocyte recovered may substantially alter the outcome of that IVF cycle.~      The objective of the research is to evaluate the effect of follicular flushing in poor~     responders on IVF cycle outcomes.~   "
153424|NCT01558128|"~     To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop~     postoperative atrial fibrillation~   "
153425|NCT01558115|"~     Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone~     (PTH) and high blood calcium, is one of the most common endocrine disorders. PHPT is seen~     most often in postmenopausal women. Many patients with PHPT have low bone mineral density~     (BMD) when bone mass is measured by dual energy x-ray absorptiometry (DXA), primarily at the~     forearm. There is currently no effective medical therapy which increases bone density at the~     forearm in patients with PHPT.~      PTH both builds and breaks down bone, and the pathways by which PTH mediates these actions~     are beginning to be identified. Prior research suggests that RANKL, a molecule important in~     bone metabolism, responds to PTH, and that if the RANKL is inactivated, PTH is shifted~     towards building bone. The investigators will study the effect of Denosumab, a therapeutic~     agent that binds to and inactivates RANKL, in 28 postmenopausal women with PHPT. Our~     hypothesis is that Denosumab will increase bone mineral density in primary~     hyperparathyroidism.~      The study will last two years, and subjects will be randomly assigned to receive either~     placebo or Denosumab for the first year of the study. In the second year, all subjects will~     receive Denosumab. Denosumab (60 mg) or placebo will be given every 6 months by an injection~     just under the skin. Study procedures performed will include bone mineral density tests by~     DXA, high-resolution peripheral quantitative computed tomography (HR-pQCT) scans, and~     assessments of biochemical markers of calcium metabolism and bone turnover using both blood~     and urine samples of subjects with PHPT.~   "
153426|NCT01558102|"~     The primary objective of this retrospective study is to determine the incidence of important~     safety outcomes in patients who have undergone Pipeline Embolization Device placement for~     intracranial aneurysms (IAs). This study does not effect patient care, simply it is designed~     to observe and capture information from numerous hospitals.~      Data collection will be initiated starting March 2012 and continue until approximately April~     2017.~   "
153427|NCT01558089|"~     This open-label, prospective, observational study will evaluate the clinical response to~     etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis,~     as prescribed by the rheumatologist in a normal clinical setting in Greece~   "
153428|NCT01558076|"~     The purpose of this study is to use comprehensive exercise testing to examine longitudinal~     changes in exercise capacity over a 2 year period in children and young adults with sickle~     cell anemia.~   "
153429|NCT01558063|"~     Depressed patients will be offered experimental treatment with a new, potentially fast-acting~     antidepressant called ketamine while being scanned by magnetic resonance imaging (MRI) to~     measure the chemical effect of the drug. Ketamine will be given in a dose of 0.0 (placebo),~     0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg. If a patient does not respond to ketamine after the first~     infusion, it may be because s/he received ketamine placebo or the dose of ketamine was too~     low. In that case, an optional second scan and infusion of active ketamine (0.5 mg/kg) will~     be offered. This second scan will occur no later than weeks after the first scan/infusion (as~     scheduling permits). There is no guarantee that the patient will respond to the second~     ketamine infusion. Patients enrolled in the study are eligible for up to 6 months treatment~     with their study psychiatrist after the ketamine infusion(s).~      Healthy Volunteers: Healthy controls will receive an infusion of ketamine at a single dose~     (0.5 mg/kg). Volunteers will only receive one MRI scan and infusion.~   "
153430|NCT01558050|"~     In this study the investigators investigate the effect of a red rice product on plasma lipids~     in a sample of physicians and/or their family members.~      After a baseline measurement of cholesterol, HDL, LDL and TG, participants are randomised to~     receive a commercially available red rice product or placebo. After a period of 8 weeks,~     lipid levels are measured again.~   "
153441|NCT01557907|"~     The primary objective of this study is to investigate if intradermal (in the skin) basal and~     bolus insulin delivery of a fast acting insulin analog (NovoRapid) as needed to adequately~     control the blood glucose for a subject with Type 1 Diabetes can be maintained for a period~     of up to three days and if intradermal delivery of insulin has advantages over standard~     subcutaneous (under the skin) delivery.~   "
153431|NCT01558037|"~     Cytomegalovirus (CMV) is a common infection with 60-90% of all adults worldwide having~     evidence of having the infection at sometime in their life. Patients who have undergone~     transplantation are at risk at developing CMV, especially those patients who do not have~     antibodies to CMV pre-transplant, but received an organ from a recipient who has antibodies~     to CMV. Usually the disease CMV causes is mild and sometimes patients are not even aware they~     have the infection without tests to detect the virus. CMV can less commonly cause serious~     infections that affect many parts of the body including the intestines, liver, or lungs. In~     rare cases CMV infection in transplant patients can cause death.~      All patients who receive a transplant are monitored for CMV infection. The purpose of this~     study is to determine if there is a way the investigators can determine in advance which~     patients are at greatest risk of CMV infection. Specifically, this study will analyze the~     immune system of transplant patients to determine if there are specific elements of the~     immune system that 1) helps protect the body against CMV infection, and 2) helps the body~     combat CMV once it is infected. Identifying these specific elements of the immune system~     could improve the physician's ability to monitor the SOT patients for CMV infection, and to~     help treat CMV in those patients that become infected.~   "
153432|NCT01558024|"~     The main objective of this study is to obtain data to determine, in each individual with and~     without wearing compression stockings of different strengths and during different postures,~     the relationship between interface pressure and the area and circumference of the great~     saphenous vein and posterior tibial veins in the calf and ankle.~   "
153433|NCT01558011|"~     This is an open-label, non-comparative phase II study of sequential capecitabine plus~     oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric~     adenocarcinoma.~   "
153434|NCT01557998|"~     Interventions for injecting drug users (IDUs) in sub-Saharan African have been almost~     entirely absent, despite the fact that in countries like Kenya they contribute a growing~     proportion of incident HIV infections. This study will leverage a historic decision in Kenya~     to launch needle exchange program (NSP) and related services for this most-at-risk population~     (MARP). The investigators will use this NSP/MARP platform to seek out IDUs, deliver rapid HIV~     testing, point of care CD4 count and link to ART using peer case managers, and evaluate~     community viral load impact using a stepped wedge cluster-randomized design. Lessons learned~     will have important applicability throughout sub-Saharan African.~   "
153435|NCT01557985|"~     This study is being done to try to learn more about how a child's body breaks down~     bupivacaine, a local anesthetic medication that is being used for pain control. This study~     will provide information about how much medication gets into the bloodstream and how long it~     remains in the blood. Newborns and young infants often process drugs in their body in a~     different way than older children. This study will help the investigators determine how~     bupivacaine is broken down in the body of infants.~   "
153436|NCT01557972|"~     Previous cross-sectional studies have demonstrated that blood pressure (BP) measurements at~     home (HBP) in the morning offer stronger predictive power for micro- and macrovascular~     complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure~     measurements (CBP) (Kamoi K et al, 2002-2003). Further, a prospective, longitudinal study for~     6 years in patients with type 2 diabetes also demonstrated that control of wakening-up HBP~     provides the stronger predictive power for the outcomes than that of CBP did (Kamoi et al,~     2010).~      However, it is not clear to show which of BP measurement provides the stronger predictive~     power for outcomes by comparing cumulative events over a longer time than 6 years. Therefore,~     the investigators examined which of HBP or CBP provides the stronger predictive power for~     outcomes in addition of renal anemia reported previously over 10 years in the patients with~     type 2 diabetes.~   "
153437|NCT01557959|"~     This phase II trial is studying how well docetaxel given together with cisplatin and~     pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB~     or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim,~     may increase the number of immune cells found in bone marrow or peripheral blood and may help~     the immune system recover from the side effects of chemotherapy. Erlotinib hydrochloride may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     dose-dense combination chemotherapy together with pegfilgrastim and erlotinib hydrochloride~     may kill more tumor cells~   "
153438|NCT01557946|"~     Primarily, this study seeks to evaluate whether citalopram treatment is associated with an~     increase in the Glutamine (Gln)/Glutamate (Glu) ratio in the anterior cingulate cortex (ACC)~     from baseline to day 3 of treatment. Additionally, this study would like to examine whether~     citalopram treatment is associated with an increase in the Gln/Glu ratio in the ACC from~     baseline to day 7 of treatment. In order to more fully examine baseline neurochemical and~     functional abnormalities in participants with MDD, we also seek to scan a group of age- and~     sex-matched non-depressed comparison individuals in order to perform between-group analyses~     of baseline neuroimaging measures.~   "
153439|NCT01557933|"~     The primary purpose of this study is to use magnetic resonance spectroscopy (MRS) to measure~     the levels of several brain chemicals including, but not limited to, glutamate, glutamine,~     and N-acetylaspartate, before and after treatment with ECT. In addition to MRS, the~     investigators will use several other MRI techniques including structural MRI, resting state~     functional MRI (fMRI), and diffusion tensor imaging (DTI) to measure how the structure and~     function of the brain changes with ECT.~      The investigators hypothesize that the Gln/Glu ratio is increased in the anterior cingulate~     cortex (ACC), but not the parieto-occipital cortex (POC), following the first ECT treatment.~   "
153440|NCT01557920|"~     The investigators hypothesize that propofol, when compared to sevoflurane, causes the upper~     airway to collapse more easily and causes less activity in the tongue muscle. Additionally,~     the investigators hypothesize that, under increased carbon dioxide concentrations of the air~     inhaled, the upper airway will be less likely to collapse under anesthesia and there will be~     increased activity in the tongue muscle under both propofol and sevoflurane, when compared to~     breathing normal concentrations of carbon dioxide, as in room air. Furthermore the~     investigators hypothesize that anesthesia disrupt the breathing swallow coordination, an~     effect additionally altered by increased carbon dioxide through increased respiratory drive.~   "
153442|NCT01557894|"~     The main aim of this study is to investigate the effectiveness of an Internet-delivered~     intervention for social phobia by comparing it to a waitlist control group. The second aim of~     the study is to track the potential changes in participants' thinking patterns. Because this~     is among the first guided Internet-delivered interventions conducted in Romania, the~     treatment credibility will also be investigated. Finally, the predictive power of anxiety~     sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.~   "
153443|NCT01557881|"~     This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging~     (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as~     PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to~     treatment~   "
153444|NCT01557868|"~     The purpose of this study is to evaluate whether the investigators can develop a computer~     algorithm to predict which individual patients will respond to injections of hyaluronic acid~     (HA) products for knee osteoarthritis.~   "
153445|NCT01557855|"~     The objective of this study is to collect data on the commercial use of Corus CAD~     (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns~     of Primary Care Physicians after receipt of their patients' Corus Score, and to better~     understand patient management patterns for clinicians ordering the test.~   "
153446|NCT01557842|"~     The purpose of this study is to determine if early ablation (i.e., ablation of ventricular~     tachycardia in patients with infrequent VT episodes) is more effective than medical therapy~     alone for the treatment of ischemic ventricular tachycardia in patients with Implantable~     Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia~     despite drug therapy.~   "
153447|NCT01557829|"~     This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into~     two groups: one to receive a new ceramic implant and a control group with a more traditional~     PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will~     measure and compare pain and disability improvement with the two implanted devices over a~     period of two years. The fusion status will also be judged with plane x-rays and one CT scan.~   "
153448|NCT01557816|"~     This study aims to evaluate various methods of measuring pain relief in subjects who have~     chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be~     treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day~     followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment,~     subjects will have another week of wash-out followed by a second period of 1 week of the~     alternate treatment. Subjects will not be allowed to use oral non-steroidal anti-inflammatory~     drugs (NSAIDs) or other oral analgesics, or topical medications on their target knees during~     the study. Acetaminophen will be allowed as a rescue medication.~   "
153449|NCT01557803|"~     The objective of this project is to determine clinical and biological predictors of Immune~     Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are~     started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of~     this syndrome. The investigators will prospectively study HIV infected patients in Sub~     Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its~     different appearances. In these patients, the investigators will assess the value of clinical~     features and plasma biomarkers to predict IRIS, and the investigators will obtain insight~     into which inflammatory pathways become activated during IRIS. This project will provide~     novel knowledge about this clinically highly relevant healthcare problem in a resource poor~     setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little~     research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will~     be described. Promising putative plasma biomarkers will be validated for their use in daily~     practice.~   "
153450|NCT01557790|"~     Phase II study using Proton radiation therapy to treat males, aged 18 years or older, with~     Stage I, IIA and IIB Seminoma. This research study will be done in conjunction with the~     Robert H. Burr Proton Therapy Center at the Mass. General Hospital and the Department of~     Defense. In the feasibility portion of the study patients will be evaluated to determine~     acute toxicity. If the study is deemed feasible the principal investigator (PI) hopes that~     proton RT will reduce the lethargy rate as compared to photon radiation therapy (RT).~   "
153451|NCT01557777|"~     Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).~   "
153452|NCT01557764|"~     This phase II trial studies the effectiveness of lapatinib ditosylate (lapatinib) together~     with trastuzumab in treating patients with HER2-negative breast cancer that carries HER2 gene~     mutations. Lapatinib may kill tumor cells by blocking some of the enzymes needed for cell~     division and growth. Trastuzumab, a monoclonal antibody, may block the ability of tumor cells~     to grow and spread. Giving lapatinib together with trastuzumab may provide a more effective~     treatment for patients with this type of cancer.~   "
153453|NCT01557751|"~     In preparation for future large-scale genome wide association studies, reliable methods must~     be developed for measuring perceived pain and for estimating the effects of potentially~     confounding factors such as appropriate covariates. The major objectives of our pilot~     investigation are to develop optimal methods to characterize the primary endpoint of the~     study—knee pain, and to gather preliminary data on genetic markers in the human genome that~     are associated with a certain pain phenotype. The specific issues for this study will be to~     carry out a preliminary gene association analysis of acute perioperative pain in individuals~     undergoing total knee replacement and to define a pain phenotype that is composed of~     multidimensional domains such as opioid consumption, inflammatory markers, anxiety level,~     degree of catastrophizing, etc. This pain phenotype has to be sensitive enough to pick up~     changes in pain experience that can be attributed to single nucleotide polymorphisms.~   "
153465|NCT01557595|"~     Patients with ADHD often report staying up late on the computer, watching TV, or using other~     electronic devices, all strong emitters of blue light which may be contributing to the~     delayed sleep onset times seen in some of these patients. Evening use of polarizing glasses~     which filter out blue light may decrease the contribution of environmental light late at~     night to delayed bedtime. This is a treatment that Dr. Fargason uses when patients do not~     want to use sleep medication to help them fall asleep. The purpose of this study is to~     evaluate the effectiveness of this treatment by use of sleep diaries and sleep~     questionnaires.~   "
153454|NCT01557738|"~     It has well known that diets rich in fruits, vegetables and cocoa products are associated~     with positive health benefits and these positive effects have been shown to be due to~     compounds they contain called flavanols. Flavanols have been shown to exert their positive~     effects by indirectly increasing nitric oxide (NO) bioavailability. NO is a potent~     vasodilator that is believed to play a role in increasing blood flow to active muscle during~     exercise. This regulatory process is impaired with healthy aging. The underlying premise to~     this study is that if NO bioavailability can be increased following flavanol ingestion, will~     there be a restoration of blood flow during exercise in older individuals? Accordingly, the~     first part of this research project will compare the acute vascular effects of flavanol~     ingestion between a young and old group. The investigators have hypothesized that both groups~     will show an improvement in blood flow to active muscle during exercise, though the magnitude~     of the change will be greater in the older group. The second part of this project will look~     at the effects of 4 weeks of daily flavanol ingestion in the old group. The investigators~     hypothesize that subjects will demonstrate an improvement in blood flow to active muscle~     during exercise after the 4 week intervention and that the magnitude of the change will be~     greater than the acute effects. Findings from this proposal will provide evidence for the~     efficacy of flavanols to be used (as a simple and safe lifestyle intervention) to reverse or~     combat impaired blood flow regulation in older individuals.~   "
153455|NCT01557725|"~     There are many different views regarding ideal duration and type of thromboprophylaxis after~     hip or knee surgery.~      An important factor in Fast-track surgery is early mobilization, which in itself is thought~     to prevent clotting.~      The investigators hypothesize that there is no increase with regards to thrombosis in~     patients receiving fast-track surgery with early mobilization and chemical thrombosis~     prophylaxis only during hospitalization.~   "
153456|NCT01557712|"~     The objective of this study is to evaluate the effectiveness of ketamine (infusion of~     0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major~     depression (MADRS score ≥ 20 ) to six weeks of treatment.~   "
153457|NCT01557699|"~     This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be~     given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV~     by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will~     be followed for 180 days for safety.~   "
153458|NCT01557686|"~     The purpose of this pilot study is to test an exercise-based multidimensional intervention~     for patients with acute leukaemia undergoing consolidation chemotherapy in the context of~     outpatient management. Further, to test for safety, feasibility and preliminary effect on~     physical and functional capacity, and health related quality of life.~   "
153459|NCT01557673|"~     Following surgery some patients are unable to swallow. For those requiring nutritional~     support a tube is sometimes passed through the nose into the stomach to provide feeding.~     Traditionally this type of feeding is given slowly over the course of the day. However, it is~     thought that this mode of feeding might increase the amount of fluid entering the bowel~     contributing to symptoms of diarrhoea. An alternative strategy of feeding, given in larger~     volumes in a shorter space of time resembles normal feeding patterns and may reduce the~     amount of water entering the bowel.~      In this study we want to use a non invasive medical imaging technique called magnetic~     resonance imaging (or MRI) to look at the volume of bowel water following these two feeding~     strategies in 12 healthy volunteers.~      Each volunteer will have a tube inserted into the stomach via the nose and undergo the two~     feeding strategies at least 7 days apart. We will take repeated images using the MRI scanner~     to assess the bowel response and some samples of blood are required for analysis of blood~     sugar.~   "
153460|NCT01557660|"~     Open-label extension of RIN-PH-302.~   "
153461|NCT01557647|"~     To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and~     time to clinical worsening.~   "
153462|NCT01557634|"~     The incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid~     increase in preschool children. Intensive control of blood glucose levels, although essential~     to protect against onset and progression of diabetes-related complications, faces unique~     challenges in toddlers and preschool children. A closed-loop system can enhance accuracy of~     insulin delivery and help people with T1D attain a tight glucose control avoiding the risk of~     hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an~     insulin pump and a computer-based 'model predictive algorithm', which calculates the amount~     of insulin to be given by the insulin pump according to the CGM values. In the studies~     performed thus far the efficacy and safety of closed-loop glucose control were evaluated in~     children and adolescents aged 6 to 18 years. The results showed that closed-loop improved~     control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the~     conventional insulin pump therapy. The objective of the current study is to extend the~     evaluation of closed-loop further to younger children aged 2 to 6 years, who may gain a great~     benefit from this novel therapy. The present study adopts an open-label, randomised, 2 period~     cross-over design whereby closed-loop insulin therapy using diluted insulin (20IU/ml)will be~     compared with closed-loop with standard insulin (100IU/ml)in 12 young children with T1D.~     Participants aged 2 to 6 years will be randomised for two overnight studies in a clinical~     research facility, during which glucose levels will be controlled by either the~     computer-based closed-loop algorithm using diluted insulin or by closed-loop with standard~     insulin. On both occasions, participants will receive a self-selected evening meal and~     closed-loop will run from 17:00 until 08:00am the following day. The study will take place at~     the Wellcome Trust Clinical Research Facility, Cambridge with participants recruited from~     paediatric diabetes clinics in England.~   "
153463|NCT01557621|"~     The purpose of this study is to determine if a collaborative centralized population-based~     reminder/recall intervention is more effective than a traditional practice-based~     reminder/recall intervention at increasing immunizations among young children.~   "
153464|NCT01557608|"~     Numbness, tingling, and pain in the hands and feet following the administration of~     chemotherapy (also called chemotherapy-induced neuropathy (CIN)) is a common problem in~     oncology patients. However, more information is needed on why patients develop neuropathy and~     how it impacts their mood, ability to function, and their quality of life. In addition,~     effective treatments for this problem are not available at the present time. This study will~     be conducted in two parts. In Part 1, patients who have finished chemotherapy and did or did~     not develop CIN will be evaluated to determine why some patients do and other patients do not~     develop CIN. In addition, the impact of CIN on patients' mood, function, and quality of life~     will be evaluated by comparing patients' reports on these important outcome measures. In~     addition, genetic markers that contribute to or protect against the development of CIN will~     be evaluated. Part 2 of this study will test the effects of a new treatment called photon~     stimulation (also called infrared light therapy) compared to placebo treatment to improve~     sensations in the feet of oncology patients with CIN. Patients who receive the photon~     stimulation will have greater improvement in sensation in their feet compared with those who~     do not receive photon stimulation.~   "
153466|NCT01557582|"~     The primary endpoint of this study is the percent difference between the VentriPoint Medical~     System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular~     volumes (RVEDV and RVESV) in subjects with Pulmonary Arterial Hypertension (PAH). The trial~     will be defined as positive if the mean VMS-cMRI percent difference is <10% and >-10% at a~     1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns~     for the VMS procedure.~   "
153467|NCT01557569|"~     The purpose of this study is to examine the ability of atomoxetine compared to placebo to~     increase time to relapse in methamphetamine dependent volunteers. Our hypothesis is that~     atomoxetine will increase time before (if) the participant relapses.~   "
153468|NCT01557556|"~     Background:~      - Stressful situations often cause tobacco cravings. These cravings can make it very~     difficult for smokers who are trying to quit. Research has shown that craving may involve~     hormone pathways in the brain. The anti-anxiety drug pexacerfont acts on these hormone~     pathways. Researchers want to see if pexacerfont can act on the brain and lessen~     stress-related tobacco cravings in smokers who are trying to quit.~      Objectives:~      - To test the effects of pexacerfont on tobacco craving in smokers who want to quit smoking.~      Eligibility:~      - Smokers between 18 to 55 years of age who are trying to quit. (Participants must have~     smoked at least 10 cigarettes per day for at least 1 year.)~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will be assigned to take either pexacerfont or a placebo. They will take~          three pills every morning for the first 7 days, then one pill every morning for 23 days.~        -  At the first visit, participants will provide blood and urine samples. They will then be~          asked to prepare a 5-minute speech and give it to the study researchers. They will also~          be asked to do mental math problems for another 5 minutes. During these tests, blood~          pressure, heart rate, sweating, and skin temperature will be measured. Participants will~          fill out questionnaires about stress levels, tobacco cravings, and personal experiences.~        -  Participants will take the study pills for 30 days. Before the 2-week point,~          participants will be asked to try to quit smoking for 2 weeks.~        -  Participants will have four study visits. These visits will involve brain imaging scans~          and emotional stress tests. Tobacco cravings and other stress levels will be measured at~          each study. Blood and urine samples may be collected at these studies.~        -  Participants will have follow-up visits and phone calls for up to 6 months after the end~          of the study visits.~   "
153469|NCT01557543|"~     Background:~      - Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated~     and are found to make large amounts of growth factors. Because they make growth factors,~     these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged~     heart muscle suggest that injecting these cells directly into damaged heart muscle can~     improve heart function. Researchers want to give stem cells to people who are having open~     heart surgery to see if they can help to repair heart muscle damage.~      Objectives:~      - To test the safety and effectiveness of bone marrow stromal stem cell injections given~     during heart surgery to treat heart muscle damage.~      Eligibility:~      - Individuals at least 18 years of age who are scheduled to have open heart surgery for heart~     artery or vein blockages.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected.~        -  Participants will have bone marrow taken from both hip bones about 3 weeks before the~          heart surgery.~        -  During the surgery, the stromal stem cells collected from the bone marrow will be given~          into the damaged portion of the heart muscle. The rest of the heart surgery will be~          performed according to standard procedures.~        -  After the surgery, participants will be monitored for complications from the stromal~          stem cells.~        -  Participants will have heart function tests to see if the stromal stem cell treatments~          were effective.~   "
153470|NCT01557517|"~     Background:~      - Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow~     transplants. It is the result of the donor cells trying to attack the recipient s body.~     Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors, and~     painful swallowing. Steroids are a possible effective treatment for GHVD, but they can cause~     side effects when given as pills or injections. Steroids given in a cream or rinse form,~     applied directly to the site of the symptoms, can have fewer side effects. However, their~     effectiveness as a rinse has not been tested in the mouth. Researchers want to see if a~     steroid called clobetasol can be used as a mouth rinse to treat oral GHVD.~      Objectives:~      - To see if a clobetasol rinse is a safe and effective treatment for oral graft-versus-host~     disease.~      Eligibility:~      - Individuals at least 12 years of age who have oral GHVD and are not allergic to clobetasol.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will also have an oral exam, a mouth tissue biopsy, and~          other tests before starting the study drug.~        -  Participants will be separated into two groups. One group will receive clobetasol; the~          other will have a placebo liquid.~        -  Participants will rinse their mouths with the study liquid three times a day after meals~          for 2 weeks.~        -  After 2 weeks, participants will have another study visit with blood tests and other~          exams.~        -  After the study visit, all participants will start to use the clobetasol rinse. Those~          who originally had clobetasol will use the rinse for another 2 weeks. Those who~          originally had a placebo will use the rinse for 4 weeks.~        -  Participants will have a follow-up exam after the end of treatment....~   "
153471|NCT01557504|"~     The purpose of this study is to assess:~        1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in~          pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years~        2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two~          sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets~          (excluding marking)~        3. the pharmacokinetics of sitagliptin and metformin following the administration of two~          sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM, aged~          10 to 17 years.~   "
153472|NCT01557491|"~     Loss of hair growth potential in long surgical scalp incisions can become obvious to the~     patient and others, given hair's tendency to part along the resulting scar. Bevelling~     incisions perpendicular to the hair follicle angle may increase hair growth through the scar.~     However, many factors may be confounders such as wound tension and cauterizing the incision.~     This study will investigate the effect a bevelled incision has on hair growth preservation~     compared to a standard incision that incises the skin perpendicular to its surface~     irrespective of hair follicle angles. Following informed voluntary consent, subjects who~     require bi-coronal scalp incisions as part of a surgical plan will be enrolled. The right~     side of this bilateral incision will be randomized to receive either a bevelled or a standard~     incision and the left side will receive the opposite type. During routine surgical follow-up~     the hair growth within the scar of the two sides will be recorded for comparison and it is~     our hypothesis that the side with the bevelled incision will have more hair within the scar.~   "
153473|NCT01557478|"~     The study evaluate the effect of melatonin in improving quality of life and reducing post~     operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a~     multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or III~     breast cancer patients. Mixed-block randomization, stratified by center and treatment scheme~     is used to divide eligible patients into two groups: melatonin 20 mg or matched placebo. The~     patients are required to take the studied drugs at night (after 21.00 pm) on the first night~     prior to surgery and continue for 24 months. Standard treatment is surgery followed by~     chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT-B),~     pain (VAS 0-10), adverse event frequency, sleep quality (VAS 0-10), recurrence rate and~     progression-free survival.~   "
153474|NCT01557465|"~     The purpose of this study is to determine whether mechanical alternans (alternating strong~     and weak heart beats with a constant beat-to-beat interval), can be used to predict malignant~     ventricular arrhythmias, requiring defibrillation or appropriate ICD therapies, and to~     predict progression of heart failure and death.~   "
153475|NCT01557452|"~     Givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular JIA~     through the inhibition of the production/release of pro-inflammatory cytokines, such as~     IL-1β, IL-6 and TNFα, which are involved in the pathogenesis of the arthritic process.~   "
153476|NCT01557439|"~     This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this~     study is to assess the bioequivalence between Test Product and the corresponding Reference~     Product under fasting condition in normal, healthy, adult, human subjects.~   "
153477|NCT01557426|"~     Objectives:~      This study aims to characterize severe skin and soft tissue infections (SSTIs) in the~     emergency department through the acquisition of ultrasound images. A wide range of SSTIs will~     be imaged and recorded, leading to a registry of these infections. The registry will show~     whether ED (emergency department) sonographers can accurately characterize these infections,~     as compared to the final hospital diagnosis. The registry will also provide data for a~     case-control study comparing ultrasonographic characteristics of necrotizing skin and soft~     tissue infections (NSTIs) to those of non-necrotizing SSTIs.~      Research procedures:~      In this study, the investigators will approach patients who present to the Emergency~     Department with a possible skin and/or tissue infection. Study subjects must be ED patients~     requiring admission to the hospital for the primary problem of an SSTI due to the need for~     follow-up. If the patient consents to participating in the study, the investigator will~     obtain and record an ultrasound image of the infected area. An ultrasound image of an~     uninfected area of skin will also be recorded for comparison. Patient information regarding~     personal history, physical examination, blood tests and x-rays will also be gathered from~     participants.~   "
153478|NCT01557413|"~     Primary purpose of this study was to compare functional outcomes after displaced and proximal~     humerus fracture between nails and locked plates.~      The hypothesis is that intramedullary nails provides satisfactory fixation and functional~     outcome compared to locked plate.~   "
153479|NCT01557400|"~     Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is~     caused by a mutation in the gene for dystrophin, a protein that is important for maintaining~     normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads~     to weakness and loss of walking ability during childhood and teenage years. A specific type~     of mutation, called a nonsense (premature stop codon) mutation, is the cause of DBMD in~     approximately 10-15% of boys with the disease. Ataluren is an orally delivered,~     investigational drug that has the potential to overcome the effects of the nonsense mutation.~     This study comprises a Phase 3, open-label study of ataluren in patients with nmDBMD who~     previously received ataluren at an investigator site in a prior PTC-sponsored clinical study.~     A separate open-label study (PTC124-GD-016-DMD) is being conducted for nmDBMD patients who~     previously received ataluren at an investigator site in the United States (US).~   "
153480|NCT01557387|"~     Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds~     expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could~     decrease the need and expense of endoscopic biopsy for these lesions.~      Hypothesis: Pseudopolyps will have a distinctive pattern with the specialized imaging~     techniques of high definition imaging, narrow band imaging, and endoscopic dye-spraying~     techniques using indigo carmine which will predict diagnosis without biopsy.~      100 patients with inflammatory bowel disease will be enrolled in the study. Following a~     standard bowel preparation, each patient will be evaluated using standard endoscopic~     equipment. All patients will receive a standard bowel preparation (sodium phosphate,~     PEG-3350, or magnesium citrate based preparations). All colonoscopic evaluations will be~     performed for indications unrelated to the present study, including evaluation of response to~     medical treatment, routine surveillance exams for dysplasia, diarrhea, or rectal bleeding.~     Polypoid lesions will be examined using four consecutive methods: (a) high definition white~     light, (b) narrow band imaging, (c) chromoendoscopy (high definition white light with indigo~     carmine dye-spraying), and (d) histologic examination following biopsy. The flat mucosa~     surrounding the polypoid lesions will also be examined using theses four techniques in an~     effort to identify dysplastic tissue associated with these polypoid growths.~      High definition white light is the standard imaging modality used for colonoscopy. Narrow~     band imaging (blue wavelength of light) is also used routinely and is available on all~     current generation colonoscopes with the press of a button. Our division routinely uses~     chromoendoscopy as part of surveillance for dysplasia in patients with inflammatory bowel~     disease. Dye spraying catheters or flushing will be utilized for dye application to mucosa.~     The dye used will be indigo carmine.~      Directed biopsy specimens will then be performed using a multibite forceps for targeted~     biopsies. Routine biopsies will be performed as clinically indicated. Pathology slides will~     be reviewed by the gastrointestinal pathologists at the University of Miami. The~     gastroenterologist's interpretation based on each of the three successive endoscopic methods~     will then be compared to the histologic evaluation with each individual lesion serving as its~     own control.~   "
153481|NCT01557374|"~     Ever since the biotherapy agents have entered the market, the recommended therapeutic~     objective in Rheumatoid arthritis, has been remission. Once obtained, it is advised to try to~     reduce or cease these biotherapy agents, for which, their efficacy is counterbalanced to~     their tolerance in the medium and long term as well as their high price. Nevertheless, we do~     not dispose considerable data on the risks of relapse or structural progression during such a~     step down strategy. A few studies on anti-TNF agents have shown the possibility of such~     therapy reduction. A national study,  STRASS , coordinated by Bruno FAUTREL, has evaluated~     the possibility of spacing or even stopping the injections of anti-TNF(s). To date, no data~     concerning Abatacept or Tocilizumab has been published.~      As the expected result, this study is aimed to test the feasibility of a step down strategy~     on 2 biological agents, Abatacept and Tocilizumab, in RA patients in remission.~   "
153482|NCT01557361|"~     The objectives of this trial are to determine whether, in critically ill patients with severe~     acute kidney injury (AKI), randomization to accelerated initiation of renal replacement~     therapy (RRT), compared with standard initiation, is:~        1. Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates,~          and achievement of follow-up; and~        2. Safe, from the perspective of potential adverse events associated with earlier~          initiation of RRT~   "
153483|NCT01557348|"~     This multicenter, prospective, observational study will assess the efficacy of~     MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid~     arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will~     be collected from each patient from the time of change in biologic therapy for 12 months.~   "
153484|NCT01557335|"~     This study is designed to provide data on platelet aggregation of PA32540 plus clopidogrel~     dosed separately compared to EC aspirin 81 mg plus EC omeprazole 40 mg plus clopidogrel dosed~     concomitantly.~   "
153485|NCT01557322|"~     1. To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world~          setting across two moderate RA cohorts: a Test Group of patients newly exposed to~          etanercept (Enbrel) therapy and a Control Group of patients with similar disease~          characteristics newly exposed to other, non-biologic therapies.~        2. To assess the change over time (from baseline to the most recent follow-up) in the~          characteristics described at baseline in 2 British Society for Rheumatology Biologics~          Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying~          anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).~   "
153486|NCT01557309|"~     The optimal timing for surgical repair of traumatic rotator cuff tears is controversial.~     Today there are no prospective studies investigating the short to mid-term outcome after~     early arthroscopic repair of traumatic rotator cuff tears and the Swedish National~     Musculoskeletal Competence Centre requests more research to this subject. The investigators~     will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair~     during the first year after surgery.~      The investigators hypothesise that the outcome after rotator cuff repair is good.~   "
153487|NCT01557296|"~     The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2~     and gastroparesis:~        -  validate radiopaque markers with fluoroscopy with gastric scintigraphy method~        -  study the difference of metabolic control including the frequents of hypoglycaemia,~          gastrointestinal symptoms, quality of life and nutrition state during dietary treatment~          of food of small particle size compared with food of large particle size~        -  validate the radiopaque markers method and measurement of the blood glucose and~          gastrointestinal symptoms after a test meal, against the gastric scintigraphy~        -  determine if the function of gastric emptying can be improved after intervention~   "
153488|NCT01557283|"~     With the new reimbursement criteria, we want:~      To describe the average treatment duration of patients with Enbrel expressed as a number of~     weeks/year.~      To describe the number of patients who receive continuous treatment To describe the number of~     patients who receive intermittent treatment To describe the number of weeks off treatment~   "
153489|NCT01557270|"~     The purpose of this study is to test the efficacy and safety of dexmedetomidine added to~     ropivacaine in patients undergoing shoulder surgery.~   "
153490|NCT01557257|"~     To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the~     administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice~     Daily in Healthy Volunteers~   "
153491|NCT01557244|"~     The objective of the study is to find out if the medicine fesoterodine is a useful treatment~     in children with bladder muscle overactivity caused by a neurological condition. Children~     will be aged 6 to 17 years old. This is done by finding out how well it works, what the body~     does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It~     will be compared with the medicine oxybutynin, which is already available for treating the~     condition.~   "
153492|NCT01557231|"~     Chronic pain, by definition, persists over long periods of time, but both sufferers of pain~     and their caregivers are aware that pain levels can fluctuate greatly over time. Being able~     to define pain variability and its underlying causes would be an important advance in our~     understanding of chronic pain, and would in turn lead to better approaches to the treatment~     of chronic pain. In this study, the investigators propose to evaluate in 60 people with~     chronic pain of the knee due to osteoarthritis over 3 months, collecting data regarding~     magnitude of pain, physical activity level, and medication status twice daily during this~     period of time. The investigators then will assess the variability in pain levels over time,~     the frequency of flares of osteoarthritis (OA) pain and their relationship to physical~     activity, medications, and clinical descriptors of the population, e.g., age, gender, body~     mass index (BMI). Additionally, evaluations will be made regarding temporal patterns of OA~     knee pain as well as assessment of subgroups of patients with the overall group being~     studied.~   "
153493|NCT01557218|"~     Intake of vegetables and fruits in preschool children is less than recommended amounts.~     Although offering a variety of foods has been shown to increase intake, this effect has not~     been well studied for low-energy-dense foods. The purpose of this study was to test whether~     increasing the variety of vegetables and fruits served to preschool children affected the~     amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would~     increase both the amount selected and the amount eaten.~   "
153494|NCT01557205|"~     The investigators will obtain human skin specimen (sized approximately 1 cm x 1 cm) for~     dermatological surgical patients in National Taiwan University Hospital, after informed~     consent was obtained. Human skin keratinocytes, fibroblasts, and melanocytes will be cultured~     from the human skin specimen. The three dimensional images of these cultured cells will be~     observed by a ultra-high resolution 3-dimensional optical coherence tomography.~   "
153495|NCT01557192|"~     To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS)~     as an antidepressant treatment in subjects with mood disorders.~   "
153496|NCT01557179|"~     This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place~     at four centers in China. The primary objective of this study was to assess the efficacy and~     safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we~     tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to~     that of estriol cream, with no clinically significant difference between them, in the~     treatment of vaginal dryness symptoms.~   "
153497|NCT01557166|"~     This trial is conducted in North America. The aim of the trial is to investigate the effect~     of liraglutide in obese subjects with sleep apnoea.~   "
153508|NCT01557023|"~     This trial will study the percentage of women with at least one occurrence of intracyclic~     bleeding (bleeding and/or spotting) during the cycles 2 and 3 of treatment with test or~     reference drug.~   "
153509|NCT01557010|"~     The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in~     Postherpetic Neuralgia.~   "
153510|NCT01556997|"~     The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination~     drug compared to two other drugs (monotherapies) in controlling hypertension.~   "
154881|NCT01538992|"~     Sympathetic system has important role occurrence of symptoms in heart failure. Renal~     denervation that is ablated some of sympathetic nerves is affected pathology of heart~     failure. This interventional therapy improves symptoms and life quality.~   "
153498|NCT01557153|"~     Depression has a high occurrence and causes other problems in older people, two thirds of~     these patients will not have a lessening in their condition from routine treatment~     medication. About half have a form of depression known as 'vascular depression'.~     Augmentation, the addition to, antidepressant treatment with a vascular type of treatment~     (such as a group of medications called Calcium Channel Blocker including the medication~     called amlodipine) may be effective in this group of patients but previously published~     studies have been from highly selected specific patient groups. The investigators would like~     to find out if giving amlodipine medication to people with late life non-responding vascular~     depression would be acceptable to this patient group. The investigators would also like to~     know how they feel while having the treatment and whether this provides a measurable benefit~     for those patients and whether those benefits are relevant to the patients. The investigators~     would also like to find out the information the investigators need to plan and prepare for a~     larger version of this study.~   "
153499|NCT01557140|"~     Chronic Chagas cardiomyopathy causes substantial morbidity and mortality in Latin America.~     Whether RAS inhibitors and beta-blockers are safe and beneficial has been challenged because~     of the lack of formal trials. Hence, the objective of this study was to determine the safety~     and efficacy of renin-angiotensin system (RAS) inhibitors and beta-blockers in chronic Chagas~     cardiomyopathy. This way, the investigators conducted a double-blind, placebo-controlled, and~     randomized trial in 42 patients with Trypanosoma cruzi infection and cardiomyopathy. All~     patients received enalapril (up-titrated to 20 mg BID) and spironolactone (25 mg QD).~     Subsequently, the patients were randomly assigned to receive placebo (n = 20) or carvedilol~     up-titrated to 25 mg BID (n = 19). The primary end points were change in left ventricular~     ejection fraction (LVEF) after RAS inhibition and that after the addition of carvedilol. The~     secondary end points were changes in other echocardiographic parameters, Framingham score,~     quality of life (36-item Short-Form Health Survey), New York Heart Association class,~     radiographic indices, brain natriuretic peptide levels, and chemokines as well as safety end~     points.~   "
153500|NCT01557127|"~     This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate~     the actual dosing of Nexavar in real-life setting vs. the prescribed dose.~   "
153501|NCT01557114|"~     RATIONALE:Anti-melanoma activity of Ipilimumab both as a single therapy and in association~     with melanoma peptides has been shown as well as synergy between radiation therapy and~     anti-CTLA-A mAb in several tumor animal models for both local tumor control and distant~     effects.Radiotherapy increases tumor immunogenicity in several preclinical models by~     increasing MHC molecules expression and is able to induce significant tumor reduction in~     around 30% of cases. Thus, combining radiotherapy and administration of ipilimumab could~     elicit systemic antitumor response. Radiation therapy will expose tumor-associated antigens~     (TAA) and facilitate antigen presentation, and further blockade of CTLA-4 could amplify the~     immune antitumor response. In this therapeutical model, the use of the own patient tumor as a~     source of tumor antigens (in opposition with other vaccination protocols, where TAA are~     exogenic) is particularly adapted.~      PURPOSE: This Phase I trial determines the side effects and best dose of radiation therapy~     administered in combination with ipilimumab.~   "
153502|NCT01557101|"~     The purpose of this study is to determine if the adherence to screening in first grade~     relatives of patients with CCR is higher than optical colonoscopy.~   "
153503|NCT01557088|"~     The majority of the acute coronary events are caused by coronary artery segments with minimal~     luminal disease, but with potentially significant vascular wall inflammation and oxidative~     stress leading to plaque vulnerability. It has become apparent that an initial injury at the~     endothelial surface, is the primary site of the mechanisms involved and a role for vascular~     inflammation and the interaction with oxidative stress continues to emerge.~     Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a novel biomarker for vascular wall~     inflammation that circulates in the blood bound to both low density (LDL) and high density~     (HDL) lipoprotein and promotes vascular inflammation. Circulating levels of Lp-PLA2 mass and~     activity are an independent risk factor for cardiovascular events. Recent studies,~     demonstrating that Lp-PLA2 is also associated with coronary endothelial dysfunction. However,~     the relationship between Lp-PLA2 and early atherosclerotic changes in the coronary arteries,~     and the contribution of lipoprotein binding to the deleterious potential of Lp- PLA2 have not~     been elucidated. Our working hypothesis is that the endogenous local activation of the~     Lp-PLA2 pathway plays an integral role in early coronary atherosclerosis and contributes to~     the mechanism of coronary endothelial dysfunction and the structural and mechanical~     properties reflecting plaque vulnerability. Thus, the current application will characterize~     prospectively the correlation between the functional, mechanical, and structural vascular~     wall properties, and the systemic as well as the coronary activity of the Lp-PLA2 pathway.~   "
153504|NCT01557075|"~     The purpose of this study is to determine whether high dose statin therapy in patients with~     aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and~     were free of the adverse cardiac events during the first 12 months could be superior over~     pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events~     during the additional 12 months.~      Study Design.~   "
153505|NCT01557062|"~     Objectives: To assess the effect of passive body heating on the sleep pattern of patients~     with fibromyalgia.~      Methods: Six menopausal women diagnosed with fibromyalgia according to criteria determined by~     the American College of Rheumatology were included. All women underwent passive immersion in~     a warm bath at 36±1 °C, for 15 sessions of 30 minutes each over 3 weeks. Their sleep pattern~     was assessed by polysomnography at the following conditions: pre-intervention (baseline), on~     the first day of intervention (acute), on the last day of intervention (chronic) and 3 weeks~     after the end of interventions (follow-up). Core body temperature was evaluated by a~     thermistor pill at the above-mentioned conditions. The impact on fibromyalgia was assessed~     through of a specific questionnaire called fibromyalgia impact questionnaire.~   "
153506|NCT01557049|"~     The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation~     (GPR) program in subjects with chronic low back pain.~   "
153507|NCT01557036|"~     The primary objective of this study is to further expand the body of clinical knowledge in~     patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial~     aneurysms (IAs or ICAs) according to Pipeline's labeled indication.~   "
153511|NCT01556984|"~     Endothelial dysfunction is the early step of atherosclerosis. Therefore, the investigators~     hypothesize that digital subtraction angiography (DSA) can damage endothelial function. In~     this study, the investigators will select 200 diabetic patients who have a DSA for diabetic~     foot screening. Also, the investigators will select 100 healthy subjects as controls. The~     endothelial function will be determined by high resolution ultrasound before and after DSA.~     The investigators will observe the changes of endothelial function after DSA assay.~   "
153512|NCT01556971|"~     The objective of this proposed study is to obtain data on the efficacy of Botox in reducing~     symptoms of MDD in male and female patients between the ages of 18 and 65 years old.~      The secondary object is to visually assess each patient's frown before and after the Botox~     injection to determine if there is a correlation between changes in the frown and changes in~     mood. The patients will be photographed at screening, visit 2 and 3. Their frown lines will~     be compared to determine if there is a visible improvement in the frown lines corresponding~     to an improvement in the efficacy rating scores.~   "
153513|NCT01556958|"~     The primary goal of the study is to more firmly establish correlations between~     WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry,~     provider's auscultation, and symptoms at the time of Wz% measurement.~   "
153514|NCT01556945|"~     The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS,~     combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are~     safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines~     can prevent malaria infection.~      The RTS,S vaccine contains a malaria protein in combination with a portion of the~     commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein.~     The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study~     days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd~     vaccination.~   "
153515|NCT01556932|"~     This randomized clinical trial studies ABH (lorazepam, diphenhydramine hydrochloride, and~     haloperidol) gel in patients with nausea. ABH gel, when absorbed into the skin, may be an~     effective treatment for nausea and vomiting. The general purpose of this research study is to~     improve the treatment of nausea and vomiting.~   "
153516|NCT01556919|"~     The investigators are looking at a novel approach to measuring gastroesophageal reflux~     disease (GERD) damage and reducing the need for costly and less optimal testing presently~     used for diagnostic and treatment purposes. The investigators will be using three custom~     mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on~     the esophagus.~   "
153517|NCT01556906|"~     The primary objective of this study is to evaluate the safety and tolerability of 4 doses of~     lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an~     additional 3 dose levels over a 16-week period.~      The secondary objectives of this study included the evaluation of the pharmacodynamics of~     lomitapide based on:~        -  Percent change in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC),~          triglycerides, and very low density lipoprotein cholesterol (VLDL-C) concentrations at~          the end of each 4-week dosing period compared to the Baseline value of each parameter at~          the end of the previous dose phase(s).~        -  Changes in other plasma lipoproteins: apolipoproteins (apo B, apo AI, apo AII, apo CIII,~          apo E) and lipoprotein a [Lp(a)].~   "
153518|NCT01556893|"~     This will be a prospective, single-center clinical trial of up to 50 eyes of subjects~     scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be~     screened for eligibility.~      Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to~     excimer laser treatment.~      Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the~     stromal bed quality, and the amount of opaque bubble layer. All patients will be followed~     with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity,~     manifest refraction, slit lamp examination, and endothelial cell counts.~   "
153519|NCT01556880|"~     The purpose of this study is to prevent the professional drivers from pre-diabetes to~     diabetes.~   "
153520|NCT01556867|"~     At birth, the umbilical cord is cut, separating physically and symbolically the mother of his~     child. Before cord drop, umbilical area is a possible way of bacterial infection. Thus,~     umbilical cord infections constitute a major cause of neonatal morbidity and mortality in~     developing countries. In industrialized countries, omphalitis cases have almost disappeared~     whatever cord care strategies. At this day, care practices appear extremely different between~     countries, based more on habits and convictions that on evidence-based medicine. The~     investigators propose to conduct a non inferiority multicenter clustered crossed randomized~     study. Observations sessions will be performed on two consecutive periods of 5 months: 4~     months of recruitment and 1 month follow-up. Main objective is to demonstrate that dry cord~     care practice would not expose to a higher risk of omphalitis than antiseptic based care~     approach. The purpose of NEOCORD study is a simplification of cord care for paramedical teams~     and parents, but also a significant reduction of costs in a medico-economic approach.~   "
153521|NCT01556854|"~     The primary objective of this study is to compare effectiveness of five different~     neuroprotectants, including butylphthalide, edaravone, citicoline, cerebrolysin, and~     piracetam, among patients with acute ischemic stroke.~      The secondary objectives of the study are as follows:~        -  To compare safety of five different neuroprotectents, including butylphthalide,~          edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic~          stroke.~        -  To compare cost-effectiveness of five different neuroprotectents, including~          butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with~          acute ischemic stroke.~   "
153522|NCT01556841|"~     The purpose of this trial is to assess the effectiveness of TroVax® compared to placebo in~     extending the time to progression in patients with asymptomatic relapsed platinum resistant~     ovarian, fallopian tube or primary peritoneal cancer.The trial will also look at overall~     survival times and quality of life.~   "
153523|NCT01556828|"~     The goal of this study is to identify genetic changes associated with the initiation,~     progression, and treatment response of response of cutaneous and hematologic disorders using~     recently developed high-throughput sequencing technologies. The improved understanding of the~     genetic changes associated with cutaneous and hematologic disorders may lead to improved~     diagnostic, prognostic and therapeutic options for these disorders.~   "
153524|NCT01556815|"~     Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular~     carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release~     of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell~     proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may~     benefit from sorafenib in combination with TACE.~   "
153525|NCT01556802|"~     The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in~     patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five~     days, then perform periodic evaluations to determine the status and degree of neurological~     sequelae developed.~   "
153526|NCT01556789|"~     Open label, two part, Phase 1 dose escalation study to evaluate the safety and immunogenicity~     of repeat dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid~     tumors. Part 1 to evaluate escalating dose levels of ONT-10 administered subcutaneously every~     two weeks (Q2W) or weekly (QW) over 8 weeks. Part 2 evaluates the safety, immunogenicity, and~     potential anti-tumor activity of ONT-10 administered over 8 weeks at the Q2W and QW maximum~     tolerated does/recommended dose (MTD/RD) in cohorts of 15 patients each.~   "
153527|NCT01556776|"~     CLLM1 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study that compares the efficacy and safety of oral lenalidomide maintenance therapy to that~     of placebo maintenance therapy in high-risk subjects with Chronic Lymphocytic Leukemia (CLL)~     who have achieved at least a partial response (PR) and either:~        -  MRD levels of ≥ 10-2 or~        -  MRD levels of ≥ 10-4 - < 10-2 combined with at least one of the following factors:~             -  an unmutated IGHV-status~             -  17p-deletion or~             -  TP53 mutation after first line therapy with FCR, FR, BR or FC (in case of of~               contraindications to receive Rituximab).~   "
153528|NCT01556763|"~     This study in patients with schizophrenia is designed to provide preliminary evidence of the~     safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2~     doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic~     medication.~   "
153529|NCT01556737|"~     Alleged benefits experienced after the consumption of soy in Asian countries have been~     attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are~     believed to relieve menopausal symptoms and are therefore often consumed in supplement form~     in Western countries. These supplements contain relatively high amounts of isoflavones and~     are on the market in different compositions. The question is whether supplements with~     different compositions exert similar effects or whether the effects differ substantially.~   "
153530|NCT01556724|"~     Peripheral nerve blocks are the standard of care for pain management after hip replacement~     surgery at UPMC Shadyside. This prospective, randomized study is intended to assess the~     effect of 0.1 versus 0.2% ropivacaine in lumbar plexus nerve catheter infusions after total~     hip arthroplasty. Ropivacaine peripheral nerve block infusions have been utilized as the~     standard of care at UPMC Shadyside for many years. Ropivacaine, a less potent left-isomer of~     bupivacaine, is often used in place of bupivacaine due to less motor blockade and less severe~     cardiovascular and central nervous system potential toxicity.~      The primary goal of this study to examine the effect of a low concentration infusion of~     ropivacaine (0.1%) on postoperative analgesia (evaluated by opioid consumption after 36~     hours) compared with the standard accepted concentration of 0.2% ropivacaine in lumbar plexus~     catheters after primary total hip arthroplasty. Secondary goals are to examine motor~     function, VAS scores and patient satisfaction with pain control in low concentration 0.1%~     ropivacaine compared with 0.2% ropivacaine lumbar plexus infusions upto 36 hours after~     primary total hip arthroplasty.~   "
153531|NCT01556711|"~     The objectives of the study are to document device performance with respect to the primary~     and secondary endpoints.~   "
153532|NCT01556698|"~     The primary objective of this study is to compare the tolerability, safety and efficacy of~     NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to~     severe acne vulgaris.~   "
153533|NCT01556685|"~     This is a cross sectional Phase 4, multicenter, study of AVONEX® and JUMTAB® to determine the~     frequency of IFN induced Neutralizing Antibodies (Nabs). A secondary component is the long~     term retrospective observational evaluation conducted to measure efficacy, adherence to~     therapy, tolerability, and safety in subjects with relapsing MS related to antibody status~     and treatment.~   "
153534|NCT01556672|"~     This study will determine the prevalence of small bowel lesions suggestive of Crohn's disease~     (CD) in patients with moderate to severe plaque psoriasis using capsule endoscopy. The study~     also aims to determine if the treatment of psoriasis with adalimumab will have an effect on~     the healing of the small bowel for patients who have lesions suggestive of CD.~      Patients with psoriasis are at increased risk of developing Crohn's disease (CD), but the~     exact prevalence of CD in patients with psoriasis at this time is unknown as many patients~     probably have undiagnosed disease as the early signs will often cause no symptoms. CD is~     therefore receiving very little attention from dermatologists who are treating patients with~     psoriasis. For example, very few dermatologists will actively question patients with~     psoriasis about symptoms of CD. This lack of knowledge may induce delays in diagnosis. By the~     time the diagnosis is made and patients receive their first treatment, they may already have~     significant fibrosis and stenosis of the intestine. Current treatments, including adalimumab,~     cannot reverse small bowel anomalies to normal in the presence of fibrosis. Therefore, many~     patients with a late diagnosis will still have symptoms or will eventually require surgery~     despite good control of the inflammation. Treatment of CD should start as early as possible,~     as early treatment has been associated with an increased rate of complete healing. Complete~     control of the disease at its early stages may prevent complications.~   "
153547|NCT01556503|"~     The purpose of this study is to show how well a new device, confocal microscope, works to~     detect malignant melanoma, a type of skin cancer.~   "
153548|NCT01556490|"~     The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable~     hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All~     patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.~   "
154092|NCT01549340|"~     The purpose of this study is to determine the proportion of participants that initiate~     allergen immunotherapy (AIT) upon the recommendation of their physician and the proportion of~     participants that persist with their AIT throughout the recommended course.~   "
153535|NCT01556659|"~     Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST~     segment elevation myocardial infarction (STEMI). It is a feared complication since it might~     increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin K~     antagonist treatment in these patients. However patients with STEMI nowadays undergo primary~     percutaneous coronary intervention (PCI) with coronary stent placement and consequently~     require dual anti-platelet therapy (ascal and P2Y12 inhibitors) to prevent stent thrombosis.~     Consequently, STEMI patients with LV thrombus are currently treated with triple~     antithrombotic therapy (aspirin, P2Y12 inhibitors, e.g. clopidogrel (75 mg/d) and vitamin K~     antagonist). Patients treated with triple antithrombotic therapy are subject to a strongly~     increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet therapy as~     compared to 12% for triple antithrombotic therapy. About 10% of these bleedings are cerebral.~     The mortality of such haemorrhagic strokes is 25%. A recent retrospective analysis did not~     show any beneficial effects of addition of vitamin K antagonist to dual anti-platelet therapy~     to prevent stroke. If vitamin K antagonist-therapy could be omitted, morbidity and mortality~     due to post-PCI bleedings will decrease. Therefore, a randomized trial is warranted to~     address this issue.~      Design: A multicenter, prospective, randomized, two non-inferiority trial. The objective of~     the study is to determine in a randomized fashion the risks and benefits of the addition of~     vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients~     with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or baseline~     Magnetic Resonance Imaging (MRI).~   "
153536|NCT01556646|"~     Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality~     of life in cirrhotic patients with hyponatremia~   "
153537|NCT01556633|"~     This open-label, prospective, single dose study will evaluate the pharmacokinetics and safety~     of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a creatinine~     clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of Tamiflu.~   "
153538|NCT01556620|"~     We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical,~     USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra~     Neurosciences, USA) and that values are correlated.~   "
153539|NCT01556607|"~     The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled~     by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.~   "
153540|NCT01556594|"~     Hypoglycemia is common in people with type 1 diabetes. Mild and moderate hypoglycaemia is~     normally treated by consuming oral carbohydrates. During an episode of severe hypoglycaemia~     however, the person with diabetes is unable to consume carbohydrates and requires help from~     another person. The current standard treatment for severe hypoglycemia is intravenous glucose~     or an injection of glucagon, which causes an increase of blood glucose, which allows the~     person with diabetes to recover sufficiently to consume carbohydrate.~      AMG Medical is investigating a novel formulation of glucagon which may be easier to~     administer than the currently available glucagon formulations.~      In this study, patients with Type 1 diabetes will receive injected insulin to reduce their~     blood glucose, and will then receive one of three doses of the new glucagon formulation or a~     dose of glucagon for injection, and their blood glucose will be measured for 3 hours.~      The study hypothesis is that the new glucagon formulation will be as effective as the current~     injected formulation at raising blood glucose levels within 15 minutes.~   "
153541|NCT01556581|"~     The primary purpose of this study is to compare the effectiveness of two management~     strategies for patients with a recent onset of low back pain (LBP). One is based on usual~     care and the other is based on early access to physical therapy following a pragmatic~     treatment-based classification approach. The secondary purposes are to compare the subsequent~     healthcare utilization associated with two management strategies as well as to evaluate the~     importance of psychosocial factors on outcomes within both groups of treatment. The overall~     hypothesis guiding the study is that the additional initial treatment expense incurred by~     early implementation will result in superior short-term clinical effectiveness, and will be~     more cost-effective in the long-term due to reduced healthcare utilization. We will also~     explore the importance of psychosocial factors on outcomes within both treatment groups,~     which may provide insights for further improving treatment strategies.~   "
153542|NCT01556568|"~     The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK~     activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk~     pathway that lead to MEK activation, would be beneficial over a 6 month treatment period in~     hypertrophy regression.~   "
153543|NCT01556555|"~     This study aim to prospectively evaluate the clinical utility of Spyglass in sclerosing~     cholangitis patients undergoing endoscopic retrograde cholangiopancreaticography (ERCP).~     Fifty patients with a definite diagnosis of sclerosing cholangitis and a clinical indication~     for ERCP from September 2008 and onwards will be investigated with peroral cholangioscopy~     using Spyglass direct visualization system. Clinical data on all patients will be collected~     at time of the ERCP including information on the Primary sclerosing cholangitis (PSC) and~     inflammatory bowel disease (IBD), serum liver function tests and indication for ERCP.~      A structured data collection form including information on Majoie Score, macroscopic features~     of the bile ducts at cholangioscopy, quality of the investigation, technical difficulties,~     and an overall judgment of whether any abnormalities observed were benign or malignant was~     completed by the endoscopist in conjunction with the procedure.~   "
153544|NCT01556542|"~     The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty~     followed by nitinol stent implantation versus nitinol stent implantation in superficial~     femoral artery and popliteal artery stenosis.~   "
153545|NCT01556529|"~     The CDRM study will evaluate a newly developed approach to improve management and secondary~     prevention in diabetes care. The research will explore the impact of an medical care~     intervention via a computer-assisted diabetes risk management system (CDRMS) on compliance~     and outcome The focus will be on the effect on patients' diabetes and diabetes complication~     risk profiles, medical effectiveness and patients- reported outcomes.~   "
153546|NCT01556516|"~     This study explores the outcome and effect of pregnancy on Pompe Disease. The results are~     expected to guide clinicians in counseling and care of women with Pompe disease, who are~     planning to become pregnant, and during the pregnancy.~   "
153549|NCT01556477|"~     The proposed phase II trial is a multicenter, randomized, open-label study that will evaluate~     the efficacy and safety of azacitidine alone or in combination with lenalidomide in high-risk~     Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) with a karyotype including~     del(5q). The primary objective will be to evaluate the efficacy in terms of response~     according to International Working Group (IWG) criteria for MDS and AML after 6 cycles of~     azacitidine or azacitidine + lenalidomide treatment, or at end of study if this occurs at an~     earlier time point.~   "
153550|NCT01556464|"~     This study will test the following hypotheses:~        1. Treatment of newly diagnosed Obstructive Sleep Apnea (OSA) in acutely ill patients with~          auto-adjusting Continuous Positive Airway Pressure (CPAP) would result in fewer~          in-hospital complications, as compared to no treatment (primary outcome).~        2. Treatment of newly identified OSA in acutely ill patients with auto-adjusting CPAP would~          result in shorter length of stay, lower re-admission rate, better blood pressure (BP)~          control, better long term compliance with OSA treatment, as compared to no treatment~          (secondary outcomes).~   "
153551|NCT01556451|"~     This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean~     adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be~     enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical~     hypothesis testing will be conducted in the study.~   "
153552|NCT01556438|"~     The purpose of this study is to evaluate the safety and effect on the body of LY2127399 in~     combination with bortezomib and dexamethasone in Japanese patients with relapsed or~     refractory multiple myeloma (MM).~   "
153553|NCT01556425|"~     In this 5-year study, the investigators propose to evaluate the separate and combined effects~     of the FDA-approved formulation of extended release naltrexone (Vivitrol®) and~     employment-based reinforcement of opiate abstinence in promoting opiate abstinence and~     reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug~     users.~   "
153554|NCT01556412|"~     Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic liver disease, typically~     affecting middle aged men and is frequently associated with inflammatory bowel disease.~     Establishing diagnosis in early stages of cholestatic hepatopathy is still a clinical~     challenge and based on invasive diagnostic procedures: endoscopic retrograde cholangiography~     (ERC) or percutaneous liver biopsy are needed when magnetic resonance~     cholangiopancreaticography remains inconclusive. As these procedures are associated with~     significant risks for the patient, the goal of this study is to evaluate, if endoscopic~     ultrasound (EUS) of the biliary tract is a useful diagnostic tool in suspected PSC.~   "
153555|NCT01556399|"~     The purpose is to investigate whether polyps that look different at endoscopy, have formed~     via different mutations and have different risks of turning into cancer.~   "
153556|NCT01556386|"~     This study is to find out distribution of genetic polymorphisms and genes related to the~     chemotherapeutic drugs of ALL.~   "
153557|NCT01556373|"~     This study aims to assess the effect of acute inflammation on arterial stiffness and~     microcirculation. Patients with severe sepsis will be compared with age-, sex- and~     cardiovascular risk factors-matched controls.~      The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures~     are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate,~     cardiac output, left ventricular ejection fraction, systemic vascular resistances), central~     hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index),~     thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen,~     C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of~     metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).~   "
153558|NCT01556360|"~     The purpose of this study is to describe bone status on patients with genetic~     hemochromatosis, at diagnostic time and his evolution under treatment.~   "
153559|NCT01556347|"~     Background: Patients may develop antibodies (human leukocyte antigen [HLA] alloantibodies) to~     other human tissues via pregnancy, transfusions or previous transplantation, which limits the~     ability to find an acceptable donor heart for transplantation. Such patients are at high risk~     for antibody mediated rejection, graft failure, and acute rejection (i.e. death). For~     successful transplantation, patients must receive organs from donors who lack the HLA~     antigens that correspond to their alloantibody specificities. No successful desensitization~     strategy currently exists.~      Purpose: To determine if desensitization by deletion of immunologic memory with a multi-drug~     approach including anti-T and B cell therapies and anti-plasma cell therapy can effectively~     eliminate or significantly reduce alloantibody levels and permit highly sensitized patients~     to obtain a heart transplant. This therapy is anticipated to remove immunologic memory and~     will require re-immunization.~   "
153560|NCT01556334|"~     Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or~     azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in~     stomach upset in some patients, causing them to stop taking the medication. Therefore,~     azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach~     upset is not seen or greatly reduced. The goal of this study is to see if there is a~     difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in~     prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The~     working hypothesis is that there is no difference in the clinical effectiveness between~     antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging~     latency in PPROM.~   "
153561|NCT01556321|"~     Green tea may have positive effects for weight control and on body composition via several~     approaches such as a positive effect on the gut flora, a decrease in fat absorption from the~     intestines and an increase in resting energy expenditure.~   "
153584|NCT01556009|"~     The purpose of this study is to evaluate and compare the safety and efficacy of intermittent~     vismodegib and of Photodynamic Therapy (PDT).~   "
153585|NCT01555996|"~     This is a randomized, controlled trial to compare the efficacy of two strategies of~     non-pharmacological prevention of delirium in critically non-ventilated older patients:~        -  standard non-pharmacological prevention~        -  intensive nonpharmacological prevention (standard non-pharmacological prevention plus~          early and intensive occupational therapy).~   "
153562|NCT01556308|"~     Introduction: Epidermolysis Bullosa Simplex-Dowling-Meara (DM-EBS) is a rare genodermatosis~     characterized by spontaneous or post traumatic large cutaneous blisters. No curative~     treatment is actually available. Some data suggest a role of inflammation in the occurrence~     of blisters. The aim of this study is to study the epidermis inflammatory mechanisms in~     DM-EBS.~      Material and methods: A first retrospective immunohistochemical study will be led on~     remainder skin biopsies of DM-EBS patients took for the diagnosis. A second clinical~     multicentric prospective study will be led on 8 patients older than 1 year with severe~     DM-EBS. After informed written consent, they will answer to a standardized questionnaire. In~     case of flare of the disease, the liquid and the top of the blisters will be took. Samples~     will be analyzed in the Pr Nicolas 851 INSERM unit. After centrifugation of the liquid~     blisters, the repartition of inflammatory cells will be evaluated by Fluorescence Activated~     Cell Sorting on the pellet. Markers of inflammation will be evaluated on the surnageant with~     Luminex® technical with a multiplex targeting cytokines and chemokines. An immuno-histochemic~     analysis in association with a quantitative PCR will be made on the top of the blisters. If~     unknown, genotypic study will be made.~      Perspectives: A better comprehension of physiopathological mechanisms in DM-EBS could offer~     new therapeutic ways.~   "
153563|NCT01556295|"~     The aim of the proposed study is to evaluate knowledge on low back pain and gesture behavior~     among nurses with low back pain using validated measures and compare the findings to those~     from nurses without back pain.~   "
153564|NCT01556282|"~     Therasphere will be administered via catheter through the Hepatic Artery to treat patients~     with Hepatocellular Carcinoma and Portal vein Thrombosis.~   "
153565|NCT01556256|"~     This randomized trial studies how well music therapy and parents' education work in improving~     communication, emotional distress, and recovery in adolescents/young adult patients~     undergoing treatment for high-risk cancer and their parents. Making a music therapy video may~     improve communication, emotional distress, and recovery in younger patients undergoing~     treatment for cancer. It is not yet known whether music therapy and counseling for parents is~     more effective than information handouts for parents in improving communication and emotional~     distress in patients undergoing treatment for cancer.~   "
153566|NCT01556243|"~     RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and~     may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays~     to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that~     remain after surgery.~      PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy~     work in treating patients with multiple ipsilateral breast cancer~   "
153567|NCT01556230|"~     This project is the first comprehensive prospective study of clinically non-functioning~     pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of~     100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic and~     do not require surgery; Group II will consist of 250 patients who have pituitary lesions that~     are symptomatic and require surgery. Patients will be followed with a series of endocrine~     laboratory testing, physical examinations, testing of quality of life and neurocognitive~     function before and serially over time either during non-surgical management or after surgery~     and in some patients before and after radiotherapy (RT). Data on pituitary magnetic resonance~     imaging (MRI) studies and visual field testing being done over time during follow up as part~     of clinical care will be collected.~   "
153568|NCT01556217|"~     The purpose of this study is to investigate the concentration of JNJ-39393406 achieved in the~     blood and cerebrospinal fluid of healthy adult volunteers following administration of a~     single dose of JNJ-39393406.~   "
153569|NCT01556204|"~     The objective of this study is to conduct a prospective randomized controlled trial of~     robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.~   "
153570|NCT01556191|"~     Lung Cancer is to become the first cause of death related to cancer in France as it's already~     the case in United States. At Present, Lung Cancer in women and in men is treated similarly.~     Nevertheless, numerous studies shows that lung cancer in women has specificities : at the~     time of the diagnosis female patients are younger, there are less clinical signs, clinical~     stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker .~     Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response~     rate to chemotherapy is better. Prognosis is better~      Numerous hypotheses have been put forward to account for the specific characteristics of~     female lung cancer described above.~        -  One hypothesis is that there are different genetic anomalies in women. Some studies show~          an increase of EGFR mutation and HER2 expression and a decrease of expression of repair~          enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to tabagism and~          to chemotherapy.~        -  Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer~          presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual cycle,~          hormone replacement therapy. Estrogens would have a deleterious effect on cancer~          incidence and on survival of lung cancer in women. Cellular and animal models show that~          ER pathway is activated in lung cancer and participates in oncogenesis.~        -  Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer~          cell lines and mouse models.~      EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib)~     and in women with EGFR mutations (with gefitinib). In this study, the use of these two~     treatment will be in accordance with their market authorisations.~      The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to~     EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates~     its breakdown. It has a market authorisation in breast cancer. Furthermore the association~     between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between~     RE and EGFR pathways .~   "
153571|NCT01556178|"~     In normal patients, blood and cerebrospinal fluid (CSF) contain circulating cells and other~     molecules such as proteins and nucleic acids. In patients with central nervous system (CNS)~     and other conditions, the levels of these molecules may be altered. In several other studies~     at our institution, the investigators are investigating such molecules in tumor specimens as~     well as the blood and cerebrospinal fluid of pediatric patients with CNS tumors. However,~     these levels are difficult to interpret without comparing them to levels in patients without~     CNS tumors. The investigators propose a study to collect small amounts of blood and~     cerebrospinal fluid from pediatric patients without CNS tumors who are undergoing a~     diagnostic or therapeutic neurosurgical procedure aimed at addressing altered CSF dynamics.~   "
153572|NCT01556165|"~     Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy~     in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in~     levodopa-treated PD patients with motor fluctuations.~      The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety~     of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.~   "
153652|NCT01555125|"~     The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI~     and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type~     psoriasis.~   "
153573|NCT01556152|"~     Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent~     injury to peripheral nerves that has major implications on quality of life (QOL), morbidity,~     and costs from a public health perspective. Painful diabetic neuropathy affects 16% of~     patients with diabetes. Pharmacological agents used in the management of painful DPN mainly~     include tricyclic antidepressants, selective serotonin and norepinephrine reuptake~     inhibitors, opioids, and anti epileptic drugs. However, only two drugs (duloxetine and~     pregabalin) have been formally approved by the EMEA and the US FDA for the treatment of~     painful DPN. Generally, the available treatment options do not give total relief, are not~     effective in all patients, and only about one-third of patients may achieve more than 50%~     pain relief. Hence newer therapies are required for the treatment of DPN.~      This is randomized, double-blind, placebo-controlled, parallel group study. The study will~     include patients with type 1 or type 2 diabetes mellitus with history of pain attributed to~     DPN for least 6 months and no greater than 5 years.~      Patients will be recruited after providing written informed consent.~   "
153574|NCT01556139|"~     The reduction in effort tolerance as result of a decreased efficiency in ventilation is~     common both in patients affected by COPD (McKenzie) and chronic heart failure (CHF) (Ribeiro,~     Frankenstein). One of the most common cause is the reduced respiratory muscle strength and~     endurance. Some studies have evaluated the effect of a specific training on the muscular~     strength both in pulmonary (Battaglia, Powell) and cardiac patients (Winkelmann, Chiappa).~     Moreover, only few studies investigated a specific training for such patients (Koppers,~     Sherer) because of the complicated equipment needed to prevent hypocapnia. Up to date,~     portable and economic systems for isocapnic hyperpnea have been developed for respiratory~     muscle training.~      Primary aim of the study was to evaluate the effectiveness of the respiratory muscle training~     -by the technique of the isocapnic hyperpnea- on the effort tolerance and endurance in~     patients with COPD and CHF~      Secondary aims were: A.to quantify the number of patients with deficit of respiratory muscles~     endurance and B.to verify different response of training between COPD and CHF patients~   "
153575|NCT01556126|"~     The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting~     Stent, in patients comparable to the everyday's clinical practice population, with a specific~     focus on diabetics, that will be part of a pre-specified study subgroup.~   "
153576|NCT01556113|"~     To explore whether there is a different response to omega-3 fatty acid rich diet with respect~     to the hepatic fat fraction % (HFF), triglyceride, and ALT levels between the rs738409 minor~     allele (GG) and the common allele homozygous (CC) of PNPLA3.~      Hypothesis: We expect that subjects homozygous for the minor allele of the rs73049 SNP will~     lower their triglyceride, hepatic fat content, and ALT levels more with dietary intervention~     than the common allele homozygous supplementation.~   "
153577|NCT01556100|"~     A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of~     age may be eligible for this study. Candidates are screened with a medical history and~     physical examination, and blood test.~   "
153578|NCT01556087|"~     The investigators propose that inability to tolerate the distress of opioid withdrawal and~     the negative affect associated with early abstinence are key factors in early illicit opioid~     lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing~     distress tolerance is designed to increase treatment adherence.~   "
153579|NCT01556074|"~     The primary objective of this preliminary study is to estimate sleep outcome effect sizes and~     determine feasibility for a novel yoga treatment of insomnia in participants with post~     traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of~     sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible~     mechanisms of action.~   "
153580|NCT01556061|"~     The investigators hypothesize that the D-MAC (Dblade with C-MAC system) may be a suitable~     alternative device for difficult laryngoscopy and tracheal intubation in morbidly obese~     patients. The D-MAC will enable superior view of the glottic structures as well as easier~     endotracheal intubations than the C-MAC blade. This is the first study to investigate the~     individual and comparative performances of C-MAC and D-MAC in this patient cohort.~   "
153581|NCT01556048|"~     The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed~     public health problem for which are no empirically supported treatments. The purpose of this~     application is to pilot-test Behavioral Activation (BA) therapy for PG. BA is a well~     supported, stand alone intervention for depression and recently applied to posttraumatic~     stress disorder, which reduces rumination and avoidance behaviors that otherwise thwart~     access to natural rewarding contingencies and resources. The treatment focuses on promoting~     stable, active routines, self-care behaviors, enhanced self-efficacy, and reengagement with~     pleasurable activities and significant social resources. Rumination, disengagement, and low~     self-efficacy are defining features of PG. Further, in response to loss of intimates, the key~     factors that differentiate resilient people from those that have difficulties adapting is the~     maintenance or fast resumption of social and occupational functioning. Thus, the main~     hypothesis of this study is that BA for PG will result in clinically significant reductions~     in rumination and functional disengagement. This is a preliminary small-scale pilot~     assessment of potential efficacy and feasibility of completing a large scale study of BA for~     PG.~   "
153582|NCT01556035|"~     In spite of high initial response rate after a first line treatment by R-polychemotherapy,~     cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the~     patients with PCBCL-LT. Thereafter there is no consensus concerning patients care:~     radiotherapy has only a palliative effect, advanced age often limits using more aggressive~     chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing~     cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an~     antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties.~     Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells~     lymphomas, especially of nongerminal cells phenotype. By analogy with these results,~     lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a~     manageable toxicity even in advanced age patients.~      If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its~     evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.~   "
153583|NCT01556022|"~     This is a prospective, randomized, placebo-controlled, double blind safety and feasibility~     clinical trial.~   "
153586|NCT01555983|"~     This study will demonstrate that vaporized marijuana results in antinociception when compared~     to placebo in subjects with spinal cord injury. To further evaluate potential benefits and~     side effects, the effect of different strengths of cannabis on mood, cognition, and~     psychomotor performance will also be measured.~   "
153587|NCT01555970|"~     The primary objective of this study is to determine if N-Acetylcysteine (NAC) has efficacy as~     an augmentation agent in the treatment of treatment-resistant obsessive-compulsive disorder~     (OCD). The investigators predict that NAC will reduce OCD symptoms after sixteen weeks of~     add-on treatment as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).~   "
153588|NCT01555957|"~     The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in~     late preterm and term neonates with major GI surgical disorders~   "
153589|NCT01555944|"~     This is an open, multicentre, prospective observational (non-interventional) study, performed~     in Belgium.~      Principal objectives:~        1. To evaluate the prevalence of cardiovascular risk factors and cardiac function (as~          routinely evaluated) before treatment with anthracyclines of patients with metastatic~          breast cancer (MBC) aged > or = 65 years~        2. To observe the management of cardiovascular risk during and after anthracycline~          treatment~        3. To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac~          function, outcome and quality of life (EORTC QLQ-C30)~      Secondary objectives:~        1. To evaluate the efficacy of anthracyclines on progression free survival and tumor~          response as routinely measured (e.g. recist criteria, tumor markers and other exams)~        2. To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection~          fraction, heart failure and rate according to allocated treatment.~        3. To find out how quality of life, e.g. such as described according to EORTC QLQ-C30~          criteria or Karnofsky index is achieved in the various patient subgroups~        4. To correlate the therapeutic choice and posology of anthracyclines for MBC with~          Cardiovascular risk at baseline~        5. To calculate the cardiovascular risk according to SCORE~   "
153590|NCT01555931|"~     This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their~     infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive~     method postpartum. The investigators will compare the frequency of breastfeeding among women~     receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after~     vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no~     difference in breastfeeding prevalence between the two groups.~   "
153591|NCT01555918|"~     The purpose of this study is to evaluate the pharmacokinetic properties of isavuconazole~     (BAL4815) and the cleavage product (BAL8728) and assess the safety and tolerability after~     single-dose and steady state (multiple-dose) administration of isavuconazole BAL8557 in~     healthy Chinese subjects.~   "
153592|NCT01555905|"~     The purpose of this study is to determine if inspiratory muscle strength training (IMST) will~     impact maximal inspiratory pressure and pulmonary function in patients with neuromuscular~     disease.~   "
153593|NCT01555892|"~     Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or~     T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which~     has come back, is at risk of coming back, or has not gone away after treatment, including the~     best treatment we know for these diseases.~      Some patients with Lymphoma or T/NK-lymphoproliferative disease or CAEBV show signs of virus~     that is called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever (mono~     or the kissing disease) before or at the time of their diagnosis. EBV is found in the~     cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role~     in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells (in CAEBV)~     infected by EBV are able to hide from the body's immune system and escape destruction. We~     want to see if special white blood cells, called GRALE T cells, that have been trained to~     kill EBV infected cells can survive in the blood and affect the tumor.~      We have used this sort of therapy to treat a different type of cancer that occurs after bone~     marrow or solid organ transplant called post transplant lymphoma. In this type of cancer the~     tumor cells have 9 proteins made by EBV on their surface. We grew T cells in the lab that~     recognized all 9 proteins and were able to successfully prevent and treat post transplant~     lymphoma. However, in HD and NHL, T/NK-lymphoproliferative disease, and CAEBV, the tumor~     cells and B cells only express 4 EBV proteins. In a previous study, we made T cells that~     recognized all 9 proteins and gave them to patients with HD. Some patients had a partial~     response to this therapy but no patients had a complete response. We then did follow up~     studies where we made T cells that recognized the 2 EBV proteins seen in patients with~     lymphoma, T/NK-lymphoproliferative disease and CAEBV. Those proteins are called LMP-1 and~     LMP-2. The cells are called LMP-specific cytotoxic T-Lymphocytes (CTLs). We have treated over~     45 people on those studies. About 63% of those patients who had disease at the time they got~     the cells had responses including some patients with complete responses. This study will~     expand on those results and we will try and make the T cells in the lab in a simpler faster~     way. We will also make T cells that will still see the LMP proteins but also 2 other EBV~     proteins called EBNA-1 and BARF. These cells are called GRALE T cells. These GRALE CTLs are~     an investigational product not approved by the FDA.~      The purpose of this study is to find the largest safe dose of LMP-specific cytotoxic GRALE T~     cells created using this new manufacturing technique. We will learn what the side effects are~     and to see whether this therapy might help patients with HD or NHL or EBV associated~     T/NK-lymphoproliferative disease or CAEBV.~   "
153594|NCT01555879|"~     The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical~     practice. The main hypothesis to be examined in this study is, Abatacept's effectiveness~     results in a single real-world clinic (n = 100) are reproducible at another site (n ~= 200).~   "
153595|NCT01555866|"~     This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the~     pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in~     healthy subjects with normal renal function.~   "
153596|NCT01555853|"~     This phase I/II trial studies the side effects, maximum tolerated dose, and effectiveness of~     paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients~     with recurrent or refractory Hodgkin or B-cell non-Hodgkin lymphoma. More effective and well~     tolerated therapies are needed to treat patients with relapsed and refractory lymphomas.~     Nab-paclitaxel combines a chemotherapeutic agent with a protein which may increase the~     anticancer drug concentration in the tumor while reducing toxic effects in normal tissue and~     may be an effective treatment for lymphoma.~   "
153597|NCT01555840|"~     A capsule steered by magnetic field force developed by Siemens and Olympus has recently been~     evaluated in a pilot series in man with encouraging results (Rey JF, Ogata H, Hosoe N,~     Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H. Feasibility of~     stomach exploration with a guided capsule endoscope. Endoscopy. 2010;42:541-5. Epub 2010 Jun~     30.18). This blinded prospective study investigates the accuracy of the magnetically guided~     capsule (MGCE) compared to gastroscopy in patients with focal lesions and / or gastric~     symptoms and indication for upper GI Endoscopy.~   "
153653|NCT01555112|"~     The purpose of this study is to determine whether the improved topical ointment formulation,~     AS101, is safe and effective in the treatment of external genital warts in females.~   "
153654|NCT01555099|"~     The purpose of the study is to assess the efficacy and safety of two staggered dose levels of~     inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a~     background therapy of formoterol.~   "
153598|NCT01555827|"~     A few studies suggest that patients suffering from neurodegenerative diseases (such a~     multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve~     fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical~     coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a~     precise and standardized estimation of this parameter, which could constitute a biomarker for~     cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD,~     prior to damage of the hippocampal region that impacts memory.~      Besides, some associations of AD with some degenerative diseases of the eye (glaucoma,~     microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.~      It therefore seems interesting to determine whether RNFL thickness, and other ocular~     parameters, may give some indications for a better detection of AD and cognitive decline in~     the elderly.~   "
153599|NCT01555814|"~     The investigators want to relate disturbances in first-episode schizophrenic patients in~     (dopaminergic) D2 receptors, brain structure, brain function, and information processing to~     each other and to psychopathology. Additionally, the investigators want to examine the~     influence of D2 receptor blockade on these disturbances. The investigators expect~     disturbances in the dopaminergic system at baseline to correlate with specific structural and~     functional changes and with disruption in information processing as measured with~     psychophysiological and neurocognitive methods - and investigators expect D2 receptor~     blockade to reverse some of the functional and cognitive impairments. The investigators do~     not expect any effect of treatment on brain structure.~   "
153600|NCT01555801|"~     Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the~     choices of treatment. At present, the main diagnostic method for early esophageal cancer is~     endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Thus, it is~     necessary to improve endoscopic ultrasound examination methods. This project is concerning on~     the efficacy of EUS combining with submucosal injection of saline for staging T1a and~     T1b-esophageal cancer. Patients and methods: 80 cases of pathological confirmed early~     esophageal cancer were randomly divided into two groups: endoscopic ultrasonography group~     (EUS group) and EUS combining with submucosal injecting saline group (EUS+SIS group). All the~     cases will be performance by endoscopic or surgical resection; postoperative pathologic~     diagnosis will be obtained involving echo, depth, margin and other features. The EUS results~     of two groups of patients will be compared with pathologic results. From comparison, the~     efficacy and accuracy of EUS+SIS for staging T1a and T1b in esophageal cancer patients will~     be validated. Through this study, the investigators may develop a routine diagnostic and~     accurately staging method for early esophageal cancer patients.~   "
153601|NCT01555788|"~     The primary purpose of this pilot study is to test an artificial pancreas system which uses~     the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.~   "
153602|NCT01555775|"~     The aim of this study is to assess the effect of ingesting a commercial carbohydrate and~     protein dietary supplement in powder form (P-CHO supplement) or a milk shake with skimmed~     milk, strawberries and banana (MS), after resistance exercise, in muscle damage, oxidative~     stress, inflammation and functional recovery. It is hypothesised if the ingestion of a milk~     shake with skimmed milk and fruit (strawberry and banana) has the same impact on markers of~     muscle damage, oxidative stress, inflammation and functional recovery induced by resistance~     exercise, as the intake of a commercial powder with the same CHO and protein amounts.~      Fifteen adult athletes from the Portuguese Athletic Federation will complete 2 trials~     separated at least by 2 weeks. Alternate legs and drinks will be used in each trial and~     participants will be overnight-fasted. This study will have a single-blind, randomized,~     crossover, repeated-measures experimental design. In each trial, after warm-up, the eccentric~     peak torque of the knee joint extensors will be determined using an isokinetic dynamometer.~     After this, participants will complete an isokinetic exercise until exhaustion at a constant~     angular velocity of 60° • s-1. After the exhaustion protocol, athletes will perform again the~     peak torque determination. Immediately after, participants will drink the P-CHO supplement or~     MS during the first 2 h. Both drinks will contain 0.8-1.2 g carbohydrates • kg-1 • h-1 and~     0.2-0.4 g protein • kg-1 • h-1. Twenty four and 48 h after the exhaustion protocol~     participants will return to the laboratory to repeat the peak torque determination. Blood~     samples will be collected before warming-up, immediately and 2 h after the last peak torque~     determination and 24 h and 48 h after. Serum samples will be analyzed for creatine kinase,~     lactate dehydrogenase, interleukine-6, protein carbonyls and total antioxidant status. The~     delayed onset muscle soreness, using a visual analogue scale, and girths will be measured at~     the same moments as blood sampling. Two-way repeated-measures ANOVA will be used for~     statistical analysis of the data.~   "
153603|NCT01555762|"~     This multicenter, prospective, observational study will evaluate the efficacy and safety of~     Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal~     cancer. Data will be collected from eligible patients for24 months.~   "
153604|NCT01555749|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered~     subcutaneously, at two different dose levels, in healthy Japanese subjects.~   "
153605|NCT01555736|"~     Specific immunotherapy, which involves the administration of allergic extracts to patients~     with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology.~     According to the latest studies immunotherapy not only reduces symptoms' severity but also~     may modify the course of allergic disease by reducing the risk of new sensitisations and~     development of more advanced stages of the disease.It has been hypothesized basing on~     clinical observation that perennial immunotherapy is more effective and safer in comparison~     to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial and~     preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.~   "
153606|NCT01555723|"~     Background: Treatment of HIV-1 infected Ugandan children with antiretroviral therapy (ART) is~     increasing but few prospective long-term studies evaluating the treatment process have been~     reported. In this study we sought to determine prospectively how consistent monitoring of~     HIV-1 RNA levels impacts the ART treatment process.~      Methods: One hundred and eight children initiating ART were enrolled into this study. These~     children had comprehensive laboratory monitoring including HIV-1 RNA level determination and~     genotype analysis (where appropriate), CD4 % plus absolute counts, and safety laboratory~     measurements performed prior to starting therapy and at regular intervals after receiving~     ART. Kaplan-Meier statistics were used to examine predictors of survival and virologic~     failure. Viral genotype analysis was performed on samples obtained from children having~     virologic failure to determent the emergence of mutations.~   "
153655|NCT01555086|"~     This study examines Limited versus extended pelvic lymphadenectomy.~   "
154018|NCT01550315|"~     The investigators will test the hypothesis that markers of vascular endothelial dysfunction~     will be exaggerated acutely with an extreme high sodium diet compared to an extreme~     low-sodium diet. The investigators will compare patients with postural orthostatic~     tachycardia (POTS) to healthy control subjects.~   "
153607|NCT01555710|"~     This is a multinational, multicenter, randomized controlled, open-label, adaptive study to~     evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with~     extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and~     Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio~     to receive either PaCE or CE chemotherapy.~      The study design uses an adaptive group sequential approach with sample size re-estimation at~     the interim analysis.~      Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and~     disease-related symptoms. Tumor-related endpoints will be assessed according to the Response~     Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.~      The safety of study treatments will be assessed by the frequency and severity of adverse~     events as determined by National Cancer Institute (NCI) Common Terminology Criteria for~     Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim~     analysis of safety data only will be performed.~      An independent Data Monitoring Committee (DMC) will be convened to assess the safety and~     efficacy of the study interventions and to monitor the overall conduct of the clinical trial.~   "
153608|NCT01555697|"~     Cognitive training is moderately effective at reducing symptoms and improving life function~     in schizophrenia patients. The present application develops a strategy for increasing the~     effectiveness of cognitive training through the use of pro-cognitive medications. Specific~     biomarkers will be studied that identify patients most sensitive to these pro-cognitive~     medications, to test the feasibility of using these biomarkers in a large clinical trial of~     medication-enhanced cognitive training in schizophrenia.~   "
153609|NCT01555684|"~     Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that~     often results in reduced muscle function which produces fatigue, weakness and a decline in~     daily mobility. Although the underlying cause of the disease is unknown a possible~     contributory mechanism is chronic cerebrospinal venous insufficiency (CCSVI). Post-mortem~     studies and magnetic resonance venography have shown a strong relationship between the~     cerebral venous system and MS cortical plaques. From this a role for CCSVI in MS has been~     suggested: venous malformations that result in venous hypertension, pressure on the blood~     brain barrier and subsequent inflammation due to leakage of haemosiderin into the parenchyma.~     This provokes an immune response which results in neurodegeneration. A procedure known as~     percutaneous venoplasty whereupon a balloon is inserted and inflated into the jugular vein~     has been developed to improve this drainage of the CNS, reduce venous hypertension and~     improve symptoms associated with MS. Although this procedure is widely practiced throughout~     the world it has yet to be fully accepted as it needs to be supported by evidence based~     clinical trials. As such NHS National Institute for Health and Clinical Excellence (NICE)~     recently issued a consultation document to determine more about the procedure's clinical~     safety and efficacy. A common concern raised is the ability to prevent any possible placebo~     effect and like any other clinical trial should offer a sham procedure to a matched control~     group. The difficulty with this option are the ethical issues associated with an invasive~     sham treatment and also the practical issues of masking a potentially painful treatment such~     as venoplasty. One option is to have blinded neurological assessment of patients who have~     either been treated with venoplasty or had no active treatment. Another option is to use~     dependent measures that are unaffected by motivational or psychological influences which~     avoids any placebo effect issue. One such dependent measure is motor unit firing behaviour~     whilst contracting at a submaximal target force. Typically clinicians have used this to~     manage motor disorder patients but have used cumbersome invasive technology that can only~     measure a few motor units with limited accuracy. However, De Luca et al recently developed a~     high density surface electromyographic (HDsEMG) system that can measure 30-40 motor units~     with 92-97% accuracy. From this it has been proposed as a highly effective tool for~     evaluating efficacy of therapeutic interventions for upper motoneuron disorders such as MS.~      Accordingly the investigators propose to use a repeated measures design on an experimental~     (receiving venoplasty) and control (not receiving venoplasty) MS groups (6 patients in each~     group) to determine the effect of the treatment on muscular function, mobility and fatigue.~     This would be combined with independent blinded neurological assessment of the two groups of~     patients.~      This design enables us to achieve two aims:~        1. Acute neuromuscular response to the treatment~        2. Chronic response to the treatment (6 weeks) to determine the effect on muscular~          function, mobility and fatigue.*~      Methods~        -  Four (first two to establish baseline variability of measures) repeat visits to the~          laboratory at University of Stirling to establish neuromuscular measures:~             1. HDsEMG pre and post tetanic induced fatigue~             2. Muscle fibre conduction velocity as previously described (Hunter et al., 2011)~             3. Ultrasound for CCSVI determination on visits 1 and 3~             4. DEXA scans for alterations in body composition on visits 2 and 4~        -  With the use of accelerometers monitor free living activity on days 0-7 and 9-42 (post~          venoplasty).~   "
153610|NCT01555671|"~     Labor pain is universal and occurs acutely. This is the most painful experience in a woman's~     life. Pain relief during labor is expected to have positive impact on the progress, outcome~     and cost of labor. However, it is controversial whether labor analgesia shortens the length~     of labor and influences progression to cesarean.Labor analgesia can be performed via spinal,~     epidural or systemic routes (intravenous or intramuscular). Opioid agonists (meperidine,~     fentanyl etc.) as well are the systemic agents frequently used for labor analgesia.Results of~     the studies concerning effect of meperidine on the length of labor are controversial.~      Many studies have expressed that meperidine has no effect or effect on the progress of~     labor.This study aims to evaluate the effect of meperidine on the length of active phase of~     labor in nulliparous or multiparous women, who will be randomized into case and control~     groups.~   "
153611|NCT01555658|"~     Background:~      Randomized trials show improved outcomes among acute coronary syndrome (ACS) patients treated~     with Bivalirudin1. Optimal antithrombotic treatment in patients undergoing percutaneous~     coronary intervention (PCI) is crucial to balance the risk of post-PCI bleeding versus~     ischemic complications2. Bivalirudin, a direct thrombin inhibitor has been extensively~     investigated as an intra-procedural antithrombotic therapy in patients with stable angina,~     Non ST-segment elevation acute coronary syndrome (NSTE-ACS), and ST-segment elevation~     myocardial infarction (STEMI). Bivalirudin, when used with or without glycoprotein IIb/IIIa~     inhibitors (GPI) during PCI has been found to be superior to Unfractionated heparin (UFH)~     with or without GPI in reducing 30-day bleeding complications without significant increase in~     the rate of ischemic events3-5.~      Moreover,after otherwise successful PCI,an increase in cardiac biomarkers has been shown to~     occur in 5% to 30% of patients6. Recent studies have focused their attention onthe reduction~     of infarct size and the incidence of periprocedural (type IVa) myocardial infarction~     (PMI)after elective PCI7-8. Therefore, we will perform a single-center, prospective and~     randomized study to assess if Bivalirudin versus UFHis effective in preventing elevation of~     biomarkers of MI after coronary stent implantation in patients already treated with aspirin~     and clopidogrel,with anatomically complex lesion.~      Objective:~      to assess the safety and efficacy of routine usage of the Bivalirudin vs UFH in patients with~     coronary artery disease (CAD), after stent implantation in coronary long lesions, to avoid~     periprocedural myocardial necrosis.~      Setting:~      Single-center, spontaneous, prospective, randomized 1:1 study of Bivalirudin infusion vs UFH~     in the setting of CAD, after PCI with stenting incoronary long lesions.~      Comparison: Bivalirudin vs UFH, in preventing elevation of biomarkers of MI after coronary~     stent implantation in patients already treated with aspirin and clopidogrel, with~     anatomically complex lesion.~      Population:Patients with diffuse CAD undergoing percutaneous treatment on a native coronary~     vessel with planned implantation stents in overlapping with a total stent length >33 mm for~     long coronary lesions in vessels with a reference vessel diameter 2.25-4.0 mm.~      Assessment Following the procedure, blood samples for CK, CK-MB and Troponin will be~     collected at 6,12 and 24 h post PCI. CK-MB values will be considered abnormal if they will~     elevate above the upper limit of normal (ULN). This is set at 6 mg/L by our local laboratory.~     If the first blood sample showed a CK-MB level ≥18 mg/L (≥3 times upper normal limit), a~     second blood sample would be drawn every 8 h later until a downward trend will be observed.~     For patients with two or more blood samples drawn, the peak CK-MB level will be used for~     analysis.~      End-points:~      The primary end-point of this study will be the incidence of periprocedural myonecrosis that~     was defined as a peak post-procedural CK-MB elevation > 1 time the upper limit of normal~     (ULN) alone or associated with chest pain or ST-segment or T-wave abnormalities, in patients~     undergoing non-urgent PCI.~      Secondary end-points will be the rate of MACCE (major adverse cerebro-cardiovascular events,~     ie the composite of death, myocardial infarction [defined according to the Academic Research~     Consortium statement], target vessel revascularization or stroke), the rate of major~     bleedings (Bleeding Academic Consortium [BARC] 3-5), minor bleedings (BARC 2), and the rate~     of NACE (net adverse clinical events, ie the composite of MACCE and major bleedings) at 30~     days, 6 and 12 month follow-up. Adverse events will be determined by telephone interview~     and/or medical record review. Clinical follow-up: telephone-based interviews and office-based~     direct visits will be performed at 1, 6 and 12 months, respectively, for end-point~     adjudication.~      Sample size and statistical analysis: Given an expected rate of abnormal post-procedural peak~     CK-MB > 1 x ULM of 48% (based on results of the INSTANT trial) for the control group and 29%~     for the experimental group (thus a 40% relative risk reduction), aiming for a 0.05 alpha and~     0.80 power, a total of 204 patients will need to be enrolled (102 patients per group).~   "
153612|NCT01555645|"~     The purpose of this study within Caring sciences is to identify women with breast cancer who~     have stress symptoms and to offer these women appropriate care to reduce stress and increase~     well-being. This will be achieved by~        1. Studying the prevalence of stress related symptoms in female patients with breast cancer~        2. Testing the use of two short screening instruments to identify women at risk for~          developing long-standing stress symptoms~        3. Studying the level and intensity of stress management interventions required to achieve~          increased well-being, using a stepped-care approach.~        4. Studying the effects of interventions based on cognitive behavior therapy, delivered~          individually or in a group format.~      The hypothesis is that half of the individuals assigned to a low intensity intervention will~     be significantly improved after treatment. For individuals who continue to have symptoms~     after low intensity treatment it is hypothesized that continued treatment in a group setting~     with high intensity interventions will be more cost-effective. In addition the assumption is~     that reduction of stress symptoms in women with breast cancer will lead to a reduction in~     socio-economic costs.~   "
153613|NCT01555632|"~     This randomized pilot clinical trial studies atorvastatin calcium in preventing metabolic~     syndrome in patients with prostate cancer receiving long-term androgen-deprivation therapy.~     Atorvastatin calcium may help prevent or reduce metabolic syndrome caused by long-term~     androgen-deprivation therapy~   "
153614|NCT01555619|"~     The purpose of this post approval study is to evaluate the acute and chronic performance of a~     Quadripolar CRT-D device system in a patient population indicated for cardiac~     resynchronization therapy.~   "
153615|NCT01555606|"~     The purpose of the study is to develop a database containing patient-reported information~     that may be used to understand and to increase awareness of the impact that~     moderate-to-severe plaque psoriasis can have on both daily life and life in general from a~     patient's perspective. The database will include self-reported patient narratives on the~     topic of the experience of having moderate-to-severe plaque psoriasis and will include~     information on treatments received, as well as de-identified clinical photographs taken over~     the course of the disease.~   "
153616|NCT01555593|"~     -  Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is caused by~          inflammation of peripheral airways walls.~        -  Neutrophils and other inflammatory mediators Interleukin-6 (IL6), Interleukin-8 (IL8),~          Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis Factor~          alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric Oxyde (NO)~          are implicated in the inflammation.~        -  Exhaled NO concentration is usually used to monitor bronchial inflammation~        -  The relationship between decubitus and small airways behaviour is not well understood.~        -  Our hypothesis is that cyclic opening and closure of peripheral airways during decubitus~          can provoke an inflammatory response which can be monitored by exhaled NO.~        -  Data about these physiopathological aspects is missing in literature.~   "
153617|NCT01555580|"~     The purpose of this study is to determine whether the drug Leukine (GM-CFS) is safe and~     tolerated by patients with autoimmune myasthenia gravis (MG).~   "
153674|NCT01554839|"~     The purpose of this study is to evaluate the effectiveness of a unique web based educational~     tool called Family of Heroes, which is designed to educate families about Post Traumatic~     Stress Disorder (PTSD) and provide them with practical tools for interacting with affected~     veteran family members. The study includes veterans and a family member of their choosing.~     Participants are randomly assigned to a group which takes the online training or a group that~     does not take the training. Both groups complete a baseline questionnaire and a follow up~     questionaire 60 days later. The study will examine the number of Veteran Affairs (VA) mental~     health visits.~   "
153675|NCT01554826|"~     The clinical trial was designed to evaluate the immunogenicity and safety against pediatric~     Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on~     infants age 6 months to 36 months.~   "
153618|NCT01555567|"~     Quadriceps muscle weakness is a common consequence of ACL injury. This muscle weakness is~     considered to result from neural inhibition preventing full muscle contraction and is~     referred to as arthrogenic muscle inhibition (AMI). AMI hinders rehabilitation by preventing~     gains in strength, increasing the risk of re-injury, and potentially placing patients at risk~     for chronic degenerative joint conditions. Quadriceps weakness that occurs following ACL~     injury is also thought to be caused by muscle atrophy which is thought to manifest due to~     alterations in muscle architecture, selective fiber atrophy or even neural deficits such as~     AMI. Importantly, interventions that are designed to counter this muscle weakness are~     required in order to promote long-term knee joint health. Hence, the purpose of the current~     study is to determine the efficacy of interventions that target quadriceps weakness to~     improve quadriceps muscle function and biomechanics in patients prior to and following ACL~     reconstruction. Specifically, the efficacy of neuromuscular electrical stimulation aimed at~     improving quadriceps neural activity and eccentric exercise intended to minimize quadriceps~     muscle atrophy will be investigated. The investigators expect that patients who receive the~     electrical stimulation therapy will demonstrate improvements in quadriceps strength and~     activation. Furthermore, it is expected that patients who receive both the electrical~     stimulation and eccentric intervention will demonstrate markedly greater gains in quadriceps~     strength and activation than patients who receive only the electrical stimulation therapy or~     standard of care post-surgery. The investigators also hypothesize that the patients who~     receive the electrical stimulation therapy and/or eccentrics will display knee motion similar~     to uninjured control subjects.~   "
153619|NCT01555554|"~     Understanding what treatments may facilitate perioperative care of Veterans with~     posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system.~      Patients with PTSD are characterized by elevated central nervous system catecholamine~     concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At~     present, there are no data on the effects of perioperative beta blocker therapy in patients~     with PTSD, despite the rising significance of PTSD in Veteran populations.~      This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled~     for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either~     a 14-day course of propranolol or placebo. This study will then follow these Veterans for a~     one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes.~      The investigators hypothesize that patients with PTSD randomized to the propranolol group~     will demonstrate a reduced incidence of perioperative and postoperative morbidity and~     mortality.~   "
153620|NCT01555541|"~     The goal of this clinical trial is to show that incorporating ofatumumab instead of rituximab~     in combination with etoposide and cytarabine (OVA) is successful in collecting autologous~     stem cells for use in an autologous stem cell transplantation (autoSCT) and to examine its~     effectiveness in eliminating residual diffuse large B-Cell Lymphoma (DLBCL) in patients.~   "
153621|NCT01555528|"~     This is a Mexican, Multicentre, Observational Study to evaluate Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth~     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.~   "
153622|NCT01555515|"~     In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will~     get it by a small implant of skin using their own skin, the implant will be treated in the~     laboratory and programmed to secrete Epo. The implant secretes the patients own epo~     minimizing the need for injections for a period of up to 6 months.~   "
153623|NCT01555502|"~     To test the effect of post operative complications on the health related quality of life~     (HRQOL) after Video Assisted Thoracoscopic Surgery (VATS) for Non-Small Cell Lung Cancer~     (NSCLC).~      The HRQOL of patients with early stage NSCLC will be assessed at baseline (before surgery)~     using 3 different reliable and valid HRQOL questionnaire (SF-36, EQ-5D and QLQ30/13), then at~     regular intervals in the early post-operative period (2,4,8 and 12 weeks) the HRQOL will be~     assessed using the same questionnaires to determine the difference between patients with~     low/no post operative complications to those with high grade post-operative complications.~      Post operative complications will be assess while the patients in the hospital on a daily~     basis using the Clavien classification system for surgical complications.~   "
153624|NCT01555489|"~     The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA)~     plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic~     cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic~     acid is safe when given with the chemotherapy. This Phase II trial is an initial test of~     efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard~     chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic~     cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line~     treatment. The phase I data suggests that ascorbic acid when given in combination with~     gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to~     better evaluate the response and confirm initial safety data~   "
153625|NCT01555476|"~     This study is designed to assess bioequivalence between one test and one reference~     formulation used for temporary relief of pain. The results will help decide if the new~     medicine is likely to provide pain relief similar to the product being sold.~   "
153626|NCT01555463|"~     The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam,~     15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea~     compared to its vehicle.~   "
153627|NCT01555450|"~     Variations in participation to the colorectal cancer screening seems to reveal social and~     geographical inequalities. Our study will investigate whether patient navigation could~     increase the participation to the colorectal cancer screening and in the same time, reduce~     the social inequalities.~   "
153676|NCT01554813|"~     The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The~     purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's~     Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old~     population.~   "
153737|NCT01554020|"~     This prospective international clinical trial is a two-arm, double-blind, randomized,~     placebo-controlled, parallel-group, multicenter study. 112 prediabetic subjects will be~     randomized to Blood Sugar Take Care or placebo. Randomization will be stratified by gender.~     The intervention period is 12 weeks. The primary outcome is fasting glucose levels.~   "
153628|NCT01555437|"~     Background: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical~     presentation can vary considerably. Patients are frequently assessed by capsule endoscopy~     (CE), which enables direct visualization of small bowel mucosal abnormalities; however, the~     correlations between CE scoring index (CESI), biological markers, and disease activity~     indices remain undefined.~      Methods: A prospective study was conducted between October 2008 and February 2011 on 58~     established SBCD patients and suspected patients who received a definitive SBCD diagnosis~     during study. Patients underwent complete CE, and were scored according to the CESI~     (inactive, <135; mild inflammation, 135-790; moderate-severe inflammation, >790) and~     Harvey-Bradshaw index (HBI). Statistical correlation between CESI, HBI, C-reactive protein~     (CRP), serum albumin, and hemoglobin was assessed. At follow-up (~9 months), 11 of the~     patients underwent CE with scoring for CESI, HBI, and CRP.~   "
153629|NCT01555424|"~     The investigators hypotheses is that the consumption of the investigators vitamin D fortified~     cheese will result in an increase in serum 25-hydroxy vitamin D levels in older~     institutionalized adults. Also, the consumption of the cheese with the higher amount of~     vitamin D will result in an improvement in wellbeing scores.~   "
153630|NCT01555411|"~     Akershus Cardiac Examination (ACE) 1950 Study is a large, observational, prospective,~     longitudinal, population-based cohort study. The overall aim is to establish an extensive~     cardio- and cerebrovascular age cohort of elderly subjects for various longitudinal long-term~     follow-up studies of cardiovascular and cerebrovascular disease.~   "
153631|NCT01555398|"~     The purpose of this study is to evaluate the effect of food on the pharmacokinetic~     characteristics of fenofibric acid for HIP0901 capsule.~   "
153632|NCT01555385|"~     The aim of the study is to investigate the influence of nutritive (high-protein or~     high-carbohydrate) and non-nutritive (low energy) breakfast on psychological and~     physiological responses of mental workload during multitasking in healthy volunteers.~   "
153633|NCT01555372|"~     The investigators propose to test the hypotheses that compared with Hook Plate (HP), Locking~     Plate (LP) reduces the postoperative complications and leads to a better functional recovery~     after unstable distal clavicle fractures (Neer 2b).~   "
153634|NCT01555359|"~     Autologous hematopoietic cell transplantation (HCT) is a treatment strategy used as advanced~     line therapy for different malignancies, mainly hematological. Its main advantage lies in the~     ability to provide hematologic and immune rescue after high dose chemotherapy therapy. The~     first requirement of a successful transplantation is recruitment of sufficient amount of~     cells. This is achieved by mobilizing CD34+ stem cells from the bone marrow to the peripheral~     blood, by G-CSF priming, and then harvesting the cells from the peripheral blood at the right~     timing by means of apheresis. Currently, the decision on the optimal collection timing is~     based on the pre-collection CD34 cells blood concentrations.~      The investigators goal is to investigate whether telomerase, the telomere elongation enzyme,~     which constitutionally and solely expressed in progenitor cells, is correlated with~     collection and post HCT engraftment characteristics.~      The investigators will collect blood from patients when starting GCSF and on the day of~     planned apheresis. Pearson correlation test will be used to correlate between telomerase~     activity in the samples and with collection and engraftment characteristics.~   "
153635|NCT01555346|"~     Whole blood samples will be collected from high-risk pregnant women to validate the clinical~     performance of the SEQureDx Trisomy 21 Test.~   "
153636|NCT01555333|"~     This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are~     currently participating in Protocol 2202 into a long-term study in which all subjects will~     receive active drug (arbaclofen).~   "
153637|NCT01555320|"~     CACT-IHF aims to evaluate the clinical efficacy and safety of Qishen Yiqi Dripping Pills in~     treating ischemic heart failure. Meeting the diagnosis, inclusion and exclusion criteria, the~     study plans to recruit 640 cases from 35 upper class hospitals in China, who are divided into~     two groups (treatment and control group) by central randomization service. The treatment~     group will be administrated with one bag of Qishen Yiqi Dripping Pills (0.52g/bag) three~     times a day in addition to standardized western medications. Whereas the control group will~     be given one bag of Qishen Yiqi Dripping Pills dummy (0.52g/bag) three times a day in~     addition to standardized western medications. Efficacy indicators include primary indicator~     (6 minute walk test) and secondary indicators: composite endpoint consisting of all-cause~     death, emergency/re-admission to hospital due to HF, frequency of re-admission due to~     cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock,~     revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.; Brain~     Natriuretic Peptide; echocardiography; cardiothoracic ratio; NYHA cardiac function~     classification; Minnesota life quality scale; scores from the four traditional chinese~     medicine (TCM) diagnostic methods). Other indicators include blood cholesterol, triglyceride,~     high density cholesterol and low density cholesterol. Safety indicators include blood~     pressure, heart rate, blood and urine routine tests, liver and renal function tests, serum~     electrolytes, electrocardiogram and adverse events. All of the patients will receive~     interventional drug treatment for 6 months. Follow up is needed on the 1st, 3rd, 6th, 9th,~     12th month after recruitment. All patients will be followed up until the end of study (Refers~     to the 12th month of the last case recruited into the study).~   "
153638|NCT01555307|"~     The purpose of the study was to evaluate the effectiveness of balance exercises added to~     typical joint range of motion and muscle strengthening exercises on balance in patients~     following total hip or knee joint arthroplasty~   "
153639|NCT01555294|"~     Multiple risk factors contribute to atherosclerosis, which ultimately results in clinical~     manifestation of cardiovascular disease. Atherosclerosis results in both functional and~     morphological changes in the vessel wall, which can be measured by ultrasonography. The~     current study has been designed to~        1. To evaluate whether non-invasive measurements of atherosclerosis are independent~          predictors of cardiovascular disease and~        2. to delineate new biochemical parameters and genetic variations, allowing earlier and~          more effective preventive therapy~        3. The investigators intend to set guidelines for use of NIMA in an outpatient setting to~          facilitate early detection of increased cardiovascular risk and monitor life-style and~          pharmaceutical interventions.~      In both the general population and in Familial Combined Hyperlipidemia.~   "
161537|NCT01451632|"~     The purpose of this study was to evaluate the safety and tolerability of escalating doses of~     the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.~   "
153640|NCT01555281|"~     There is a great need for treatment options in patients with multiple myeloma (MM) after~     failure of the lenalidomide/dexamethasone regimen as there is no established standard active~     therapy for these patients.~      Combining nelfinavir, a drug targeting both the proteasome and PI3K/Akt pathway, with~     lenalidomide, may restore lenalidomide-sensitivity to the disease as has been shown in vivo~     for the PI3K/Akt inhibitor perifosine and the proteasome inhibitor bortezomib.~      Patients expected to be included in the trial are heavily pretreated and might not be~     candidates for further intensive therapies. The combination of nelfinavir with~     lenalidomide/dexamethasone offers also to these patients an alternative. Preliminary~     experiences in another SAKK trial with the combination of bortezomib and nelfinavir are~     positive with few side effects with nelfinavir doses of up to 1875 mg twice daily (bid). For~     the phase I part of the trial a starting dose of 1250 mg nelfinavir bid was chosen, since the~     necessary plasma concentration of nelfinavir will not be reached with lower doses.~      In case of progression during or after the trial treatment any other lenalidomide- or~     bortezomib-based chemotherapy combination could be an option for the patient. However, the~     addition of a chemotherapeutic drug like cyclophosphamide or doxorubicin has known side~     effects like hematological toxicities, nausea, vomiting and hair loss.~      The aim of this trial is to demonstrate that the combination of nelfinavir with~     lenalidomide/dexamethasone is safe (phase I, dose escalation of nelfinavir) and active (phase~     II). Patients who do not respond to trial medication will stop trial treatment after 4 months~     of therapy at the latest.~      If the combination of nelfinavir with lenalidomide/dexamethasone should prove to be safe and~     efficient in treatment of lenalidomide-refractory MM, this would be the first orally~     available treatment for these patients and establish a new class of drugs (human~     immunodeficiency virus (HIV) protease inhibitors) as active antineoplastic agents in MM. In~     addition this would establish the concept of re-sensitizing patients to lenalidomide~     therapy and demonstrate the effect of nelfinavir on proteasomal degradation and Akt~     phosphorylation in cancer patients in vivo.~   "
153641|NCT01555268|"~     This phase I trial studies the side effects and the best dose of trebananib when given~     together with or without low-dose cytarabine in treating patients with acute myeloid leukemia~     (AML). Trebananib may stop the growth of AML by blocking blood flow to the cancer. Drugs used~     in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving trebananib~     together with cytarabine may be an effective treatment for patients with AML.~   "
153642|NCT01555255|"~     This study seeks to determine whether screening pregnant women for malaria with malaria rapid~     diagnostic tests (RDTs) may detect placental infection and predict risk of poor birth~     outcomes due to malaria in areas of varied malaria transmission in Africa.~   "
153643|NCT01555242|"~     This is a phase I, open-label, multiple dose, dose escalation study to assess the safety,~     tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally~     in patients with advanced cancer and lymphomas.~   "
153644|NCT01555229|"~     Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the~     cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic~     secretion drainage can be either continuous or intermittent. However, concerns about the~     safety of continuous subglottic secretion drainage were raised in an experimental study in~     sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is~     therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal~     mucosa damages in patients requiring mechanical ventilation for an expected duration of more~     than 24 hours.~   "
153645|NCT01555216|"~     Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of~     postoperative pain control included oral narcotics, single injection regional techniques and~     more recently continuous nerve catheters. Recent studies have demonstrated a benefit with~     continuous popliteal catheters when compared to single injection techniques in regards to~     postoperative pain control and patient satisfaction for foot surgeries.~      Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial~     nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and~     does not involve the peroneal nerve. The purpose of this study is to compare the continuous~     posterior tibial nerve catheter with a single injection posterior tibial nerve block when~     used as part of a surgical ankle block for forefoot surgery.~   "
153646|NCT01555203|"~     The objective of this Phase II research is to evaluate the effectiveness of a~     population-based, individually tailored multiple health behavior change program for exercise,~     healthy eating, and stress management in a randomized trial including approximately 1,500~     college students.~   "
153647|NCT01555190|"~     Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous~     ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our~     study is to investigate the role of folic acid conteined in the inositol preparation. The~     study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and~     subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual~     pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test,~     euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of~     treatment.~   "
153648|NCT01555177|"~     Background~      It is commonly believed that a heart attack is caused by rupture of a plaque in the wall of~     the coronary artery, resulting in blood clots which impede blood flow. Currently, the~     investigators do not know whether heart attacks in patients who had a recent surgery are~     caused by the same disease process as those who did not have any surgery. This study will~     inform the investigators of very vital information about the cause of surgery-related heart~     attacks by taking images of coronary arteries using Optical Coherence Tomography (OCT).~     Images will also be taken from heart attack patients who did not have recent surgery, and the~     two groups will be compared.~      OCT imaging~      OCT is a relatively new imaging technology which is much better at taking images of the~     inside of the artery. OCT imaging procedure is carried out at the time of scheduled coronary~     angiogram, where a catheter with a mini-camera at its tip is advanced into the coronary~     artery, it will record video images of a length of the artery. These images will take~     approximately 3-4 seconds to obtain. Besides the OCT imaging being performed, the rest of the~     angiogram procedure is carried out in exactly the same way as it would normally proceed.~      The OCT study will provide doctors with new information about the cause of surgery-related~     heart attacks, and will guide doctors in treating and preventing heart attacks in patients~     who undergo surgery.~      Hypothesis~      The investigators hypothesize that features of acute plaque rupture will be more common in~     patients with non-surgery related heart attacks compared to those which occur following~     surgery.~      Design~      Two groups of patients will be recruited(>20 in each group):~        1. non-surgery related heart attack patients~        2. patients who suffered from a heart attack following an operation.~      Outcome measures~      Using OCT, plaque features in coronary arteries of patients with heart attacks from both the~     surgical and non-surgical groups at the time of coronary angiogram will be compared.~   "
153649|NCT01555164|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to~     determine the effect of ranolazine when added to metformin on glycemic control in adults with~     type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment~     with stable metformin therapy in addition to diet and exercise.~   "
153650|NCT01555151|"~     The purpose of this study is to compare the efficacy, safety and pharmacokinetics of~     Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and~     adolescent patients with persistent asthma.~   "
153651|NCT01555138|"~     The purpose of this study is to compare the effectiveness and safety of indacaterol with~     salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive~     pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone~     propionate.~   "
153656|NCT01555073|"~     Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being~     present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has~     been hysterectomy in post child bearing woman. However, over the last decade, the use of a~     minimal invasive technique called uterine artery embolization has become increasingly popular~     due to high patient satisfaction, cost effectiveness, and shorter recovery period. The~     purpose of this randomized blinded placebo controlled study is to compare pre-emptive~     analgesia vs non-preemptive analgesia for immediate postoperative pain control, long term~     pain control, and improved quality of life in woman following uterine artery embolization~     surgery. The study consists of four drug groups including a placebo group. The addition of~     pregabalin and celecoxib together with epidural analgesia may improve pain management as well~     as leading to a better post-procedure outcome in women following uterine artery embolization.~      Many investigators believe that the ischemia in the normal myometrium is the primary source~     of pain immediately following surgery making postoperative pain management challenging.~     Epidural fentanyl may offer an advantage when encountering visceral pain. In addition to~     being an effective analgesic for chronic pain syndromes, the use of pregabalin provides~     effective postoperative analgesia when it is administered pre-emptively before an operation.~     Preemptive analgesia involves the introduction of an analgesic regimen before the onset of~     noxious stimuli, with the goal of preventing sensitization of the nervous system to~     subsequent stimuli that could amplify pain. In human trials, pregabalin has been demonstrated~     to reduce pain, improve sleep, and mood disturbances in patients with post herpetic~     neuralgia. The use of celecoxib in combination with pregabalin has shown to provide more~     effective analgesia by providing antihyperalgesia. Therefore, the addition of pregabalin and~     celecoxib together with epidural analgesia may improve pain management as well as having an~     effect on long term sequelae.~   "
153657|NCT01555060|"~     The purpose of this study is to investigate the effect of daily iron supplements after blood~     donation on time to recovery of hemoglobin and iron stores. The study will also determine~     whether the effect of iron supplements on time to recovery is different in men and women, in~     older vs. younger donors (<60 years old vs. at least 60 years old) and in donors with replete~     vs. diminished pre-donation iron stores.~   "
153658|NCT01555047|"~     Genital ureaplasmas (Ureaplasma urealyticum and Ureaplasma parvum) and genital mycoplasmas~     (Mycoplasma hominis and Mycoplasma genitalium) are natural inhabitants of the male urethra~     contaminating the semen during ejaculation. However, these microorganisms, especially~     Ureaplasma urealyticum (Uu) and Mycoplasma hominis (Mh), are potentially pathogenic species~     playing an etiologic role in both genital infections and male infertility. Despite there are~     many consentaneous opinions about its relationship with infertility, its correlation with~     sperm regular parameters is still controversially. Sperm DNA damage can negatively influence~     fertilization rate, embryo cleavage rate, implantation rate, pregnancy and live birth rate,~     and is a novel indicator for intrauterine insemination (IUI) pregnancy rate and IVF or ICSI~     pregnancy loss rate. Until now, there were fewer clinical researches about the relationship~     among Uu and/or Mh infection, sperm DNA damage, and the IUI pregnancy rate. Thus, the~     investigators conduct this prospective study to investigate the relationship among them.~   "
153659|NCT01555034|"~     The Child health and Sports Center, Meir Medical Center, has an intervention program to treat~     obese children. The program includes physical activity, nutritional intervention and~     behavioral treatment.The emphasis given in the center to physical activity and sport enables~     a strong connection with movement therapy. Movement therapy allows obese children to face and~     cope with the psychological and emotional aspects of obesity.~      The purpose of this study is to evaluate the contribution of the movement therapy~     intervention to our program.~   "
153660|NCT01555021|"~     More than one out of three individuals treated for major depressive disorder (MDD) do not~     experience a full reduction of symptoms even when treated with adequate antidepressant~     medication. These individuals may have treatment-resistant depression. This is a condition~     that contributes to the tremendous costs of MDD, in terms of health care costs, functional~     impairment (limitation of an individual's functional ability), and diminished quality of~     life.~      There is a clear need for personalized medicine, for people at high risk for~     treatment-resistant depression. If these individuals could be identified early in the course~     of their depression, they could be recommended for more intensive or specialized~     interventions. Doing so could improve their likelihood of having a full reduction in their~     symptoms.~      Today, there are many treatment options for MDD. Individuals can spend months or years in and~     out of treatment before receiving one that works for their treatment-resistant depression.~      The investigators want to study treatment resistant depression by examining specific genes~     (genotyping) that might influence how your body responds to certain antidepressant~     medications. This process of examining specific genes is not experimental. To look at your~     specific genes, the investigators will collect a saliva sample. Genes contain the material~     passed from parent to child that determines the make-up of the body and mind. For example,~     some genes control the color of your hair or eyes. Genes are contained in your DNA~     (deoxyribonucleic acid). There are many differences in DNA, from one person to another. These~     differences may affect a person's chances of having a particular disease.~   "
153661|NCT01555008|"~     This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK),~     safety and tolerability of LX4211 following once daily oral administration in subjects with~     type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.~   "
153662|NCT01554995|"~     Primary~      - To investigate the safety and tolerability of LCB01-0371 after a single oral dose~      Secondary~        -  To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral~          dose~        -  To investigate the safety of LCB01-0371 after a single oral dose~   "
153663|NCT01554982|"~     A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have~     completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may~     participate in this trial.~   "
153677|NCT01554800|"~     This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate~     the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human~     Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease~     (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose~     will be escalated by cohort.~   "
153678|NCT01554787|"~     The high levels of fatigue in stroke patients without neurological impairment suggest it has~     a central origin rather than being the result of increased physical effort required after~     stroke（Winward et al., 2009）. Fatigue is different from post-stroke depression and the more~     serious stroke patients are more prone to fatigue（Windward et al., 2009）.~      Fatigue is one of the symptoms of qi deficiency,and Astragalus membranaceus is the most~     effective of all traditional Chinese medicine and can tonifying middle and tonify the~     original qi. Therefore, the aim of this study was to investigate the efficacy of Astragalus~     membranaceus on post-stroke fatigue.~   "
153664|NCT01554969|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     the study drug, capecitabine, and radiation have on you and your cancer. Capecitabine,~     radiation, and the study drug kill cancer cells in different ways. Giving these treatments~     together may make your cancer shrink or slow down its growth more than it would if you got~     treated with capecitabine and radiation alone.~      This is a Phase I drug study of ganetespib given together with capecitabine and radiation in~     patients with locally advanced rectal cancer. Ganetespib is an experimental drug; not~     approved by the Food and Drug Administration (FDA). The other two, capecitabine and~     radiation, are approved by FDA for use in rectal cancer.~      In this study, the investigators will test different dosages of the investigational~     (experimental) drug, called ganetespib (the study drug). The study drug is investigational~     because it is not approved by the FDA for use. The study drug has been previously tested in~     humans. The study uses a well-established process of slowly increasing drug dosage to~     determine the highest dosage that can be given without causing serious side effects. In~     addition, the study will help researchers to determine what the side effects and drug~     interactions might be.~      The study will also look at the drug's pharmacokinetics (PK). PK is how the study drug and~     capecitabine with radiation work in your body (for example how long the drugs last in your~     body.)~   "
153665|NCT01554956|"~     Kedrion Human Plasminogen, a sterile human plasma-derived plasminogen preparation for topical~     ocular use will be evaluated for the indication of treatment of ligneous conjunctivitis.~      KB046 will be an open-label, historically controlled clinical trial. At least 10 subjects~     with ligneous conjunctivitis, for approximately 20 eyes, will be treated and assessed. All~     subjects will receive the investigational medicinal product (IMP) for 12 to 48 weeks, with a~     possibility for extended treatment (Continuation segment)~   "
153666|NCT01554943|"~     Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving~     node-positive early breast cancer patients with a long median follow-up (~ 15 years)~      OBJECTIFS~      Primary:~      • To compare the incidence of late cardiac events between anthracycline and non-anthracycline~     chemotherapy given to node-positive breast cancer patients in the Belgian three arm~     randomized clinical trial~      Secondary:~        -  To compare the late incidence of cardiac events between higher and lower dose~          anthracycline treated node-positive breast cancer patients;~        -  To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy~          for:~        -  left ventricular diastolic function assessed by Echo~        -  exercise capacity assessed by 6-minute walk test (6MWT)~        -  cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI~        -  serum cardiac biomarkers (BNP and TNT)~        -  patient-reported cardiac symptoms~        -  patient-reported cardiac symptoms assessed by QOL questionnaires are associated with~          subclinical findings on LVEF assessment~        -  cognitive function, functional autonomy, and psychological distress~   "
153667|NCT01554930|"~     The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a~     traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth~     disease (HFMD).~   "
153668|NCT01554917|"~     This study is intended to evaluate the safety and efficacy of Iguratimod in patients with~     active Rheumatoid Arthritis.~   "
153669|NCT01554904|"~     The study will test the hypothesis that training with the Facial-Flex exercise device for six~     weeks will improve snoring in patients with primary snoring or very mild sleep apnea.~   "
153670|NCT01554891|"~     The current study will evaluate the initial reliability and validity of a new instrument, the~     INTRuST Structured Assessment for Evaluation of TBI (SAFE-TBI), in three samples of Operation~     Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) veterans. The~     SAFE-TBI is a relatively brief measure developed by INTRuST consortium investigators and~     designed to be given by a trained administrator. It allows for a determination of the level~     of evidence for exposure to a mild traumatic brain injury (TBI) using the following~     categories: Strong, Moderate, Weak, or No Evidence of mild TBI. The first objective is to~     determine the reliability (both test-retest and inter-rater) in a sample of 100 veterans~     recently returned from deployment at Joint Base Lewis-McChord and Fort Bragg (Cohort 1), who~     have screened positive for TBI on the Post-Deployment Health Assessment. The second objective~     is to determine the concordance between the SAFE-TBI and the VA TBI Screen in 100 OEF/OIF/OND~     veterans within the Northern New England VA Research Consortium (Cohort 2). The third~     objective, to be carried out in a sample of 200 Walter Reed National Military Medical Center~     (WRNMMC) and Fort Belvoir Community Hospital OEF/OIF/OND patients (Cohort 3), is to determine~     the sensitivity and specificity of the SAFE-TBI using the INTRuST study Brain Indices of~     Risk for Posttraumatic Stress Disorder after Mild Traumatic Brain Injury initial evaluation~     as the gold standard for TBI assessment.~   "
153671|NCT01554878|"~     The purpose of the study is to evaluate prospectively the outcome of treatment interventions~     of knee osteochondral lesions Outerbridge grade III and IV.~   "
153672|NCT01554865|"~     This study aims to compare the efficacy of a partial meal replacement diet with a~     conventional diet, for inducing weight loss and improving metabolic and inflammatory profile,~     endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS),~     and quality of life in obese men.~   "
153673|NCT01554852|"~     The purpose of this study is to compare a standard chemotherapy regimen of cyclophosphamide,~     dexamethasone plus thalidomide with a newer regimen of cyclophosphamide, dexamethasone plus~     lenalidomide with or without carfilzomib.~      Patients who do not have the best response to their initial treatment may then also be given~     a combination of cyclophosphamide, dexamethasone plus bortezomib.~      Patients who are relatively fit may, on their doctor's advice, go on to receive more~     intensive chemotherapy, supported with a transplant of their own blood cells. This is~     standard treatment which patients may be offered anyway even if they didn't take part in this~     study.~      After maximal response has been achieved with the treatment described above, and as long as~     the myeloma has not got worse, patients will be treated with either long-term lenalidomide,~     lenalidomide with vorinostat, or receive no further treatment, with close observation.~   "
153694|NCT01554579|"~     The purpose of this study is to assess the efficacy of a single dose level of gefapixant~     (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA)~     of the knee compared with placebo after 4 weeks of treatment.~      The study will also assess the safety and tolerability, changes in physical function,~     stiffness, treatment response and health outcomes.~   "
153679|NCT01554774|"~     Many studies have evaluated the viability of measuring the pulmonary vascular resistance~     (PVR) by non-invasive methods in patients with pulmonary hypertension, pulmonary~     thromboembolism, ischemic cardiopathy and valvular disease. The investigators have not found~     other studies which evaluate the PVR in elderly patients with COPD. The hypothesis is that in~     patients with COPD, the severity of obstruction, expressed by GOLD class, is associated with~     an increase of PVR.~   "
153680|NCT01554761|"~     This study is to evaluate the necessity of considering posterior corneal toricity on~     refractive outcome of patients with cataracts and corneal astigmatism after implantation of~     intraocular lenses.~      This is determined by comparing total corneal and refractive astigmatism,and by comparing the~     expected refractive result with actual refractive astigmatism postoperatively,using total~     corneal and anterior corneal astigmatism to calculate respectively.~   "
153681|NCT01554748|"~     The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal~     (TMC) joint by monitoring the survival of different implant types using radiostereometry~     (RSA) evaluation of the implants.~   "
153682|NCT01554735|"~     This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced~     by exercise and diet, improves metabolic and inflammatory profile, endothelial function,~     erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in~     obese men.~   "
153683|NCT01554722|"~     Ultrasound-guided femoral nerve block is a common regional anesthesia technique. The optimal~     method of needle guidance (in-plane versus out-of-plane) with regards to the block efficacy~     and avoidance of needle-nerve contact has not been established. In this study the~     investigators tests the hypothesis that the incidence of needle-nerve contact is higher with~     the needle insertion in an out-of-plane than with the in-plane approach.~   "
153684|NCT01554709|"~     The objective of the study is to collect additional information related to the safety and~     performance of the CardioGard Cannula during bypass procedures.~   "
153685|NCT01554696|"~     The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to~     severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).~   "
153686|NCT01554683|"~     The main purpose of this research project is to study how seizure-like activity affects the~     blood flow in the brain of patients with Alzheimer's disease (AD). Changes in blood flow can~     change memory and thinking ability, as happens in Alzheimer's disease. The investigators are~     using a study drug called Levetiracetam, which helps control seizure-like activity to see if~     it can help change the abnormal blood flow in the brain that is seen in some people with~     Alzheimer's disease.~   "
153687|NCT01554670|"~     The purpose of this study is to determine whether radio-frequency (RF)-based plasma~     micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome~     with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that~     treated arthroscopic were enrolled in the study. Patients were randomly assigned to receive~     either arthroscopic subacromial decompression alone (ASD group, n=40) or arthroscopic~     subacromial decompression combined with RF-based plasma micro-tenotomy (RF group, n=40).~     Clinical outcome data including VAS(Visual Analogue Scale) pain score, Shoulder range of~     motion (ROM), ASES(American Shoulder And Elbow Surgeons) score, UCLA(University of~     California, Los Angeles) score, Constant-Murley score and SST(Simple Shoulder Test) score~     were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and~     1-year.~   "
153688|NCT01554657|"~     The goal of the study is to determine if patients who are being treated for pneumonia in the~     intensive care unit can be safely treated with five days of antibiotics (the current standard~     is seven to eight days). The goal is to determine if the investigators can minimize~     antibiotic complications while still treating the infection. Patients in the study are~     randomly assigned to either receive antibiotics for a goal of five days or a goal of seven~     days. Every patient is followed daily, and if they are not responding to the antibiotics, the~     treating team in the intensive care unit care can continue the antibiotics for a longer~     course regardless of what group the patient is assigned. The investigator's hypothesis is~     that patients in the five day treatment goal will be able to receive less antibiotics than~     patients in the seven day treatment goal without any adverse effects.~   "
153689|NCT01554644|"~     This is a randomized controlled double blinded study involving two (2) investigational sites~     in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation~     Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This~     is a 12-week study.~   "
153690|NCT01554631|"~     To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg~     taken without or with water and the Glucobay standard tablet 100 mg taken with water.~   "
153691|NCT01554618|"~     The study examines the Safety and efficacy study of exenatide once weekly in children and~     adolescents with type 2 diabetes~   "
153692|NCT01554605|"~     The objective of this study is to investigate the role of gait disturbance as a cause for~     difference in Bone Mineral Density (BMD) between both hips. Each subject will undergo the~     following tests: Functional Mobility Testing, Gait analysis, Motion Analysis, Assessments for~     Balance and Gait and Cognitive assessments.~   "
153693|NCT01554592|"~     Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function as~     a pump to move blood around the body. This sets up a complex physiologic response to~     compensate, which include activation of many hormonal mechanisms which result in fluid~     accumulation.~      In recent years, medications to block the hormonal response to heart failure are given as~     standard drugs, and these include ACE inhibitors and beta blockers. Mortality is reduced with~     these medications, as well as symptoms improved. Other medications are also used in heart~     failure, for which a clear-cut benefit has not been demonstrated. Statins, also called HMG~     CoA reductase inhibitors, are used to reduce cholesterol levels and can help to prevent heart~     failure by preventing heart attacks. They have been used in heart failure that is not caused~     by heart attacks in the belief that they had pleiotropic effects, meaning that they had~     beneficial effects in heart failure separate from the reduction in cholesterol.~      However large trials in heart failure have demonstrated that statins do not increase survival~     compared with placebo. There is no evidence to recommend their routine use in established~     heart failure caused by either heart attacks or genetics.~      The investigators propose that the use of statins in heart failure is unnecessary and could~     be stopped. The importance of finding evidence to cease unproven medications in heart failure~     cannot be understated. Patients with heart failure take an average of six prescription~     medications each day. Each medication has side effects and the interactions of all the drugs~     together are unknown. Statins are the commonest reason for side effects in patients with~     heart failure, causing muscle pains and gastrointestinal upset.~      In this study, the investigators plan to withdraw statins from patients with stable heart~     failure in a closely monitored environment and watch for the effect of this on heart failure~     and on how they feel generally.~   "
187686|NCT01107886|"~     The purpose of this study is to determine whether saxagliptin can reduce the risk of~     cardiovascular events when used alone or added to other diabetes medications~   "
153695|NCT01554566|"~     This study aimed at evaluation of the metabolic effects of honey, as a supplemental food, in~     patients suffering from type 1 diabetes mellitus. A crossover design (two 12-weeks~     intervention periods) was used to measure honey effects. The subjects were randomized into~     two groups (intervention to control [I/C] and control to intervention [C/I] groups. Each~     group consisted of 10 patients. . The subjects in the I/C group consumed 0.5 ml honey/kg/day~     in the first 12-week period (period 1) while the subjects in the C/I group did not receive~     honey as a control in period 1. After period 1 the subjects of each group exchanged their~     protocol for the following 12-week period (period 2).~   "
153696|NCT01554553|"~     The purpose of this study is to evaluate the superiority of posterior crural repair during~     sleeve gastrectomy over no repair in decreasing the incidence of symptomatic and clinical~     reflux disease.~   "
153697|NCT01554540|"~     The purpose of the study is to assess skin blood flow after non-invasive local administration~     of treprostinil by using a low-intensity current (i.e. iontophoresis) on the forearm and the~     fingers of healthy volunteers and patients with systemic sclerosis. The investigators also~     aim at assessing the systemic bioavailability and dermal diffusion of treprostinil~     iontophoresis.~   "
153698|NCT01554527|"~     Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to~     problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood.~     Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now~     performed more often for suspected SDB than for any other indication. However, recent studies~     indicate that many if not most children still have SDB after AT, and many still have learning~     or behavioral problems associated with SDB. The goals of this study are: (1) to assess the~     extent that behavior, cognition, and sleepiness in children can improve with Continuous~     positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand~     to gain most from post-operative assessment and treatment.~   "
153699|NCT01554514|"~     Thrombotic thrombocytopenic purpura (TTP) is a disease characterized by small blood clots~     throughout the body that can damage major organs and cause death. TTP is treated with plasma~     exchange (also called plasmapheresis). Patients who do not respond initially to plasma~     exchange often are helped by later treatment with rituximab. The purpose of this study is to~     see whether combining low doses of rituximab with plasma exchange will help patients get~     better sooner and reduce the chance of getting TTP again.~   "
153700|NCT01554501|"~     The purpose of this study is to examine the effects of stress on mental and physical health~     and behavior.~   "
153701|NCT01554488|"~     The Chairman of the Veterans' Disability Benefits Commission reported at a recent US Senate~     hearing that asthma, chronic obstructive pulmonary disease (COPD), and sleep apnea are among~     the top 13 most frequent diagnoses leading to disability under the Department of Defense and~     the VA system statutes. Recent research finds that sleep apnea is more common among asthma~     and COPD individuals, and this may be caused by inhaled corticosteroid use. Many Veterans are~     currently using inhaled corticosteroids, and many more will be prescribed such medications,~     given their recent inclusion in international treatment guidelines. As such, this study~     addresses a critical need by researching the role of a potent inhaled corticosteroid in~     promoting sleep apnea, the determinants of this response, and the ways through which it~     occurs. Results from this study will form the foundation for future research aimed at~     expanding understanding of the effects of inhaled corticosteroids on the upper airway, as~     well as developing means to prevent or counteract them.~   "
153702|NCT01554475|"~     So far, no drugs have shown to stop or delay the pathological processes of dementia.~     Available pharmacological treatment includes a small number of drugs; cholinesterase~     inhibitors like donepezil, galantamine and rivastigmine, and the NMDA receptor antagonist~     memantine, all of which only affect the symptoms of the disease. At the same time,~     alternative medicines like herbal products and dietary supplements are often intensively~     marketed with the assertion of curative or alleviating effects on dementia. The documentation~     of clinical effects, side effects and the potential for interaction with prescribed drugs~     are, however, generally scarce. The aims of this study are to make a survey of the use of~     alternative medicine in patients with dementia and mild cognitive dysfunction attending the~     investigators out-patient dementia clinic, and to assess the interaction potential with the~     patient's other medications.~   "
153703|NCT01554462|"~     Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD)~     receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary~     intervention. Cognitive control functions are measured with functional Magnetic Resonance~     Imaging (MRI) before and after the intervention. Behavioural change is monitored with~     behavioural scales.~   "
153704|NCT01554449|"~     The purpose of this study is to assess the efficiency of occupational therapy enhanced by~     dedicated adaptative video games in rehabilitation of the upper arm of stroke patients in~     the acute phase after their cerebro-vascular accident. Our hypothesis is that occupational~     therapy enhanced by dedicated adaptative video games is more efficient in improving motor~     recovery of the upper arm than conventional occupational therapy alone.~   "
153705|NCT01554436|"~     The low overall effectiveness of available smoking cessation treatment so far, indicate the~     need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a~     highly heterogeneous population. Identification of individual characteristics that predict~     success in smoking cessation is highly desirable to allow designing more specific strategies~     in order to enhance success in quitting tobacco.The main objective of this study is to assess~     whether the presence of certain neuropsychological deficits found before the initiation of~     smoking cessation is associated with a greater relapse rate.The secondary objectives concern~     how neuropsychological performance are involved in motivation and craving in the whole sample~     of smokers or in subsample. Long-term perspective is to define clinical or neuropsychological~     factors associated with agood or poor prognosis for success and provived more specific and~     therefore more effective care.~   "
153724|NCT01554189|"~     This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics~     (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts~     to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll~     only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a~     HCV-infected participants. All parts may run concurrently, or may be staggered as needed by~     the clinical sites.~   "
153706|NCT01554423|"~     This study is a Randomized Controlled Trial (RCT) of Integrated and Cognitive Behavioral~     Therapy for HIV Prevention in Pretoria, South Africa. The RCT will evaluate the efficacy of a~     brief motivational interview (BMI) and a cognitive-behavioral couples' (IFCBT) intervention~     alone and in combination against a comparison condition to reduce new cases of HIV and~     sexually transmitted infections and increase condom use and decrease sexual risk behavior,~     drug use, and intimate partner violence among young female drug users in Pretoria, South~     Africa and their primary intimate partners. In the RCT, 384 couples comprised of young female~     drug users who do (N = 192) and do not (N = 192) trade sex and their primary intimate~     heterosexual partners will be randomly assigned to one-of-four conditions: (1) testing and~     counseling; (2) brief motivational interview (BMI); (3) cognitive-behavioral couples'~     intervention (IFCBT); or (4) BMI and IFCBT combined. Eligibility criteria for couples include~     an HIV-negative drug using female aged 18 to 40 and their primary intimate partner or spouse~     who is also HIV negative. Each partner of each couple will be administered assessments with a~     rapid test for HIV and urine tests for Chlamydia, gonorrhea, trichomoniasis, and drug use at~     baseline and 3-month, 6-month, and 12-month follow-up.~   "
153707|NCT01554410|"~     The primary objective of the study is to identify the highest dose of gemcitabine that can be~     given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women~     with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce~     gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine to be~     feasibly delivered in patients with locally advanced cervical cancer.~   "
153708|NCT01554397|"~     The purpose of this study is to find out whether patients with cervical cancer treated with~     IMRT have less side effects with equal cancer control compared to standard radiation~     techniques. With standard radiation techniques, normal pelvic organs near the tumor receive~     radiation dose, which leads to side effects. IMRT is a new radiation technique that can~     reduce radiation dose to these organs and may reduce side effects.~      Compared to conventional RT techniques, the hypothesis is that IMRT will reduce acute~     hematologic and gastrointestinal toxicity for cervical cancer patients treated with~     concurrent cisplatin.~   "
153709|NCT01554384|"~     Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can~     detect TB genetic material in sputum samples as well as test for genetic resistance to~     rifampicin providing results within 2 hours. Xpert received WHO endorsement in December 2010.~     There is limited data on the impact of Xpert on time-to-treatment and TB-related patient~     morbidity in primary care clinics. No studies have yet evaluated Xpert performed at the~     point-of-treatment (POT) i.e. in primary care clinic location. The investigators hypothesize~     that one sputum GeneXpert MTB/RIF assay performed at the POT will improve time-to-diagnosis,~     time-to-treatment and TB related patient morbidity for patients with suspected TB presenting~     to primary level TB clinics in high HIV prevalent settings.~   "
153710|NCT01554371|"~     The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide~     (Cytoxan®) given together at different doses. This study will look at what effects, good~     and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved~     by the FDA for breast cancer that has spread to other parts of the body. Cyclophosphamide has~     been approved for different types of cancers (including breast cancer). However, the~     combination of eribulin and cyclophosphamide is considered experimental; that means this~     combination has not been approved by the FDA.~      The funding for this study is provided by Eisai Inc., the maker of eribulin.~   "
153711|NCT01554358|"~     A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009~     have and continues to be randomly assigned to either the intervention group or the control~     group. GDM women in the intervention group will have five consulting sessions with a~     dietician during the first year and two sessions during the second year. The intervention~     group are given detailed advice about how to achieve the six goals of the intervention. The~     primary aim will test whether lifestyle intervention can reduce incident Type 2 Diabetes~     (T2D) in women with prior GDM. The second aim will test gene-intervention interactions~     through fine-mapping established genes for glucose, IR, lipids, obesity and T2D in relation~     to metabolic traits for T2D in GDM women.~   "
153712|NCT01554345|"~     The purpose of this study is to determine whether Kidney injury happens in controlled~     hypotension during brain operations by using Neutrophil Gelatinase Associated Lipocalin ELISA~     Kit and if so, does VitaminE+Selenium prevent it~   "
153713|NCT01554332|"~     The purpose of this study is to evaluate the efficacy of cortical stimulation (CS) as an~     adjunctive treatment for chronic neuropathic pain.~   "
153714|NCT01554319|"~     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway~     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent~     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of~     the immune system caused by cytokine production. A substantial number of asthma patients do~     not satisfactorily respond to steroid therapy and consequently have an unmet medical need for~     novel targeted therapies with improved specificity, tolerability, and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of asthma. The~     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and~     has been shown to be necessary and sufficient for the production of cytokines interleukin~     (IL)-4, IL-5, and IL-13. The active principle hgd40 of the investigational medicinal product~     SB010 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA~     (deoxyribonucleic acid)zymes (antisense oligonucleotide). DNAzymes are catalytically active~     nucleic acids that cleave complementary RNA (ribonucleic acid) molecules. By cleaving GATA-3~     mRNA, hgd40 reduces specific cytokine production and thereby reduces key features of allergic~     airway inflammation.~      DNAzymes are generated completely by chemical synthesis and can be produced under Good~     Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs,~     i.e. they are not generated by use of any living organism including cell culture or bacteria.~     The molecules are highly water-soluble and will be applied as solution directly in their~     synthesized form.~      The current study will evaluate the safety and tolerability of increasing multiple doses of~     inhaled SB010 in healthy male subjects.~   "
153725|NCT01554176|"~     The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096)~     versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants~     who are partial responders to antidepressant monotherapy with one of identified selective~     serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors~     (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to~     placebo as augmentation therapy with respect to change from baseline to Week 6 in the~     Montgomery Asberg Depression Rating Scale (MADRS) total score.~   "
153715|NCT01554306|"~     Parkinson's disease (PD) is a neurodegenerative disorder that is characterized with motor~     symptoms such as hypokinesia, rigidity, tremor and postural instability. These symptoms can~     also be present during the night. Half of the patients with PD have difficulty turning around~     in bed. This nocturnal hypokinesia is considered as a possible cause of sleep problems in~     this population. The diagnosis nocturnal hypokinesia is based on the clinical interview.~     There is a need for a diagnostic devices that measures nocturnal movements, preferably in the~     home setting. This device can be used in the diagnostic trajectory as well in the evaluation~     of treatment. Recently the Dynaport Minimod (McRoberts, The Hague) has been developed to~     register nocturnal movements. The tri-axial accelerometer has been developed to measure~     position changes in the night. A validation study with actigraphy and polysomnography~     concluded that the Dynaport MiniMod is a valid an feasible device for assessing intensity and~     physical activity and changes of body position during sleep.~      Nocturnal hypokinesia is treated with nocturnal dopamine. Sometimes a night-time dose of~     dopaminergics is adequate, but most of the time slow release dopaminergics are needed.~     However response fluctuations can negatively influence the treatment. In these cases~     continuous dopaminergic stimulation is needed, such as rotigotine. Rotigotine treats response~     fluctuations during the day and studies show that sleep quality measured with questionnaires~     improves. If the improvement of sleep quality is caused by improved bed mobility has not been~     studied yet. The study hypothesis is that rotigotine does not influence nocturnal hypokinesia~     in PD.~      Objective of the study:~      Primary:~      • To study the effect of rotigotine on nocturnal hypokinesia~      Secondary:~        -  To study the possibility of measuring nocturnal hypokinesia and its severity in a home~          setting~        -  To correlate improvements in sleep quality by rotigotine with changes in nocturnal~          hypokinesia~      Study design:~      We will study patients who will recieve rotigotine as a part of their usual care. During~     three nights, nocturnal movements are being registered with movement sensors, before~     treatment has started as well as after a stable medication dose of one month. We will also~     assess sleep quality with questionnaires.~      Study population:~      The study population are patients with Parkinson's disease with sleep problems caused by~     nocturnal hypokinesia, who will start treatment with rotigotine. Patients will be recruited~     in the neurology patient outdoor clinic of the Radboud University Medical Centre Nijmegen. We~     will ask the treating neurologist to inform us when a patient will start treatment with~     rotigotine. One of the researchers will contact the patient to give further information about~     the study. The study is a first hypothesis generating study and we will start with the~     inclusion of 10 patients.~      Intervention (if applicable):~      Primary study parameters/outcome of the study:~      Position changes over the night.~      Secundary study parameters/outcome of the study (if applicable):~      Objective~        -  Degree of mobility, measured as the speed of the movements~        -  Total amount of movements~        -  Score on the motor symptom scale according to the MDS-UPDRS part III~      Subjective~        -  Nocturnal sleep quality Excessive daytime sleepiness~        -  Presence of nocturnal akinesia~   "
153716|NCT01554293|"~     PBL 1427 is a Dipeptidyl peptidase (DPP)-IV inhibitor being developed for treatment of type 2~     diabetes. Although a number of DPP-IV inhibitors have been described, there still exists a~     need for new DPP-IV inhibitors that have better half-life, advantageous potency, stability~     and selectivity, less toxicity and/or better pharmacodynamic properties.~   "
153717|NCT01554280|"~     The purpose of this study is to investigate whether preventative placement of a removable~     oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the~     precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The~     stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks~     later by repeat Endoscopy. Patients will be followed up weekly following insertion of the~     oesophageal stent.~   "
153718|NCT01554267|"~     In the investigators previous study of 51 breast reconstructions (32 patients), we compared~     three different assessments of vascular perfusion of tissue; clinical judgment, fluorescein~     dye angiography (FDA) and laser-assisted indocyanine green dye angiography (ICG). Because~     tissue with poor perfusion becomes necrotic and can compromise the success of breast~     reconstruction, it is important that tissue with poor perfusion be removed at the time of the~     reconstructive surgery. However, it is also important to remove the least amount of~     potentially necrotic tissue as possible so that the breast reconstruction is not compromised~     by lack of skin. Therefore finding the best way to assess potentially necrotic tissue is a~     vital clinical question. In the initial study the 3 different assessment methods which were~     made at the time of surgery were compared to the subsequent development of necrotic tissue.~      In the initial study, clinical judgment was the basis for determining the tissue removed~     because it had the potential to become necrotic. The investigators collected data with the~     FDA system and ICG system, but this data was not used in making the clinical decisions. The~     study followed the progression of tissue to overt necrosis and this clinical outcome was then~     compared to the predictions made by the three different assessment strategies. The~     investigators found that clinical judgment failed to detect tissue which subsequently became~     necrotic in 21 out of 51 instances for a failure rate of 41%. The FDA system predicted larger~     areas of potentially necrotic tissue than clinical judgment, but was found to over-predict~     the area that became necrotic by 82% - 88% (88% if all cases were included and 82% if only~     those cases which subsequently developed necrosis were included). Although the ICG system is~     similar to the FDA system in that a dye is used to assess perfusion, the ICG system has~     enhanced software which improves the estimated perfusion. The ICG system provided 90%~     sensitivity and 100% specificity in the predicted vs. actual necrotic tissue at specific~     absolute perfusion units values.~      Hypothesis: Using the values of absolute perfusion units discovered in the previous study and~     implementing its use in the operating room will decrease all-inclusive necrosis rates to~     below 10%, reflecting a 31% decrease in the investigators necrosis rate.~   "
153719|NCT01554254|"~     Engraftment failure is a major obstacle to the success of cord blood transplantation in~     children with malignancies and inherited metabolic disorders, despite the fact that they~     receive relatively high doses of nucleated cells from UCB. TXA127 is pharmaceutically~     formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (which~     contains the 8th amino acid conferring receptor binding to blood pressure receptors). TXA127~     has multilineage effects on hematopoietic progenitors in vitro and in vivo. Preclinical data~     show that TXA127 is a novel stimulator of early multilineage hematopoietic progenitors,~     increases engraftment of committed hematopoietic progenitors, and induces more rapid~     production of platelets and neutrophils in the peripheral circulation, especially in limited~     cell number transplants. Treatment with TXA127 following UCBT is expected to increase the~     numbers of hematopoietic progenitors and accelerate engraftment.~   "
153720|NCT01554241|"~     Vitamin D deficiency is highly prevalent in older people in the absence of vitamin D~     supplementation. The limited data available show marked inter-individual variability in~     response to vitamin D supplementation in very old, frail elderly with almost 25% remaining~     vitamin D deficient (25-OH D < 20 ng/mL) when receiving the currently recommended 800 IU/day~     vitamin D. This proposal is for exploratory research on the use of a wide range of oral~     vitamin D3 doses in frail elderly living in controlled living environments.~   "
153721|NCT01554228|"~     Bariatric surgery provides a strong and long-term effect in reducing weight in obese~     subjects. Studies showed that obesity and its comorbidities are associated with a lower~     cognitive performance. The aim of the researchers study is to examine the cognitive~     performance of the patients before and after bariatric surgery.~   "
153722|NCT01554215|"~     Mom Power is a weekly attachment based parenting program aimed to increase parenting and~     self-care skills for families.~   "
153723|NCT01554202|"~     According to estimations, Alzheimer's disease affects approximately 860,000 people aged of~     more than 65 years in France. This disease is characterized by disorders of cognitive~     functions, including memory, associated with structural and functional modifications of the~     brain. These changes are evolving within the pathology progression and can be evaluated with~     neuropsychological tests (to assess capabilities such as language, orientation, etc.) and~     also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood,~     nevertheless currently available treatments can slow its development if the disease is~     diagnosed early enough.~      Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to~     better describe the evolution of this disease.~      The three main objectives of this project are~        -  to identify, compare and combine predictive markers of Alzheimer's disease~        -  to make a significant contribution to the understanding of the pathophysiological~          mechanisms of Alzheimer's disease~        -  to study the ability of different neuroimaging techniques to follow the evolution of~          this pathology.~   "
153726|NCT01554163|"~     The main purpose of this study is to establish that etoricoxib 30 mg is safe and not inferior~     to celecoxib 200 mg in the treatment of the signs and symptoms of osteoarthritis in Korean~     patients. Given that the efficacy of etoricoxib vs. placebo in the treatment of~     osteoarthritis has been established, and that prescription drugs, such as celecoxib, are~     available for the treatment of pain associated with osteoarthritis in Korea, it would be~     inappropriate to subject patients with a flare of osteoarthritic pain to the placebo~     treatment for 12 weeks, and thus the study is designed as an active-comparator study.~   "
153727|NCT01554150|"~     The purpose of this study is to determine whether Method of Levels Cognitive Therapy is an~     effective intervention for treating clients with a range of presenting problems in primary~     care by comparing it with a waiting list control condition.~   "
153728|NCT01554137|"~     Stroke (CVA) is the leading cause of death and the leading cause of disability in developed~     countries as in developing countries (WHO, 2000). In the aftermath of a stroke, patients keep~     a permanent disability in 75% of cases and only one quarter of them is able to resume work.~     The post stroke sequelae are sensory-motor and cognitive.~      According to literature data, 75-83% of patients who survive a stroke learn to walk only 25~     to 45% recover use of their upper limb in activities of daily living (Friedman, 1990).~      The existence of a phase called plateau in motor recovery after stroke has been suggested~     (Colautti, 2001). This would occur beyond the 4 th month and would correspond to a phase~     where the rehabilitation techniques used in the subacute phase are deemed less effective.~     Recently, Page (2004) speculated that this plateau phase is rather the consequence of~     adaptation to the type of patient follow-up training and not that of a limit to the~     possibilities of recovery. In an observational study on the recovery of upper limb conducted~     over a period of 4 years, Broeks (2004) showed a possible recovery beyond 16 weeks post~     stroke. The results of studies on different techniques for rehabilitation of chronic stroke~     patients tend to confirm the hypothesis of page. Therefore, varying the training parameters~     (type, intensity, frequency) could improve the functional capabilities of these patients,~     even at a distance of stroke.~      Strength training is part of the management of hemiparetic patients. The results of several~     studies show an improvement in muscle strength and functional ability to walk after a~     building program isokinetic lower limb (Sharp, 1997).~      The objective of our project is to evaluate the effectiveness of a building program of~     isokinetic muscle on the paretic limb motor recovery in hemiparetic patients over 6 months of~     a stroke.~   "
153729|NCT01554124|"~     This phase I-II multicenter international trial is designed to study the pharmacokinetics of~     meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤~     90 days of postnatal age with probable or confirmed bacterial meningitis.~   "
153730|NCT01554111|"~     Objective and Hypothesis:~      The investigators objective is to help determine the efficacy of oral and rectal bowel~     preparation regimens for sigmoidoscopy. The investigators hypothesis is that oral preparation~     will reduce the amount of repeat rectal enemas required and improve the quality of a bowel~     exam at the sigmoidoscopy.~   "
153731|NCT01554098|"~     This study will compare two strategies for colonoscope withdrawal, using polyp detection as~     the primary outcome measure, to determine the optimal withdrawal strategy.~      Null Hypothesis:~      On withdrawal of the colonoscope, examining patients with dynamic position change does not~     yield more polyps than the supine position.~      Alternative Hypothesis:~      On withdrawal of the colonoscope, examining the patients with dynamic position change~     improves polyp detection compared to the supine position.~   "
153732|NCT01554085|"~     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,~     tolerability, and pharmacokinetics of orally administered ALS-002158 in healthy volunteers~     (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.~      Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will~     assess food effects on pharmacokinetics in HV.~      Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC~     genotype 1 infection.~   "
153733|NCT01554072|"~     Pulmonary rehabilitation consists of a multidisciplinary program of care for patients with~     chronic respiratory disease, which currently encompasses numerous features and physical~     training methods aimed at maintaining stability clinic for people with Chronic Obstructive~     Pulmonary Disease (COPD), especially in patients who, even with optimized clinical treatment,~     continue their decline and symptomatic physical functions and 8 so that these social. goals~     are achieved the patient with COPD should integrate into a program of RP assiduous and with~     accompanying several times per week, for several months, which for a number of factors is not~     always possible. For this reason, it is the research of methodology of RP that hold their~     effectiveness, but with greater flexibility and viability to people with COPD. On this basis,~     this study aims to investigate the effectiveness of a program of RP semi-domiciliar in which~     the patient suffering from COPD can receive guidance and training in person, to develop it~     partially in own domicile.~   "
153734|NCT01554059|"~     The purpose of the study is to evaluate the efficacy and safety of the combination of~     cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy~     as neoadjuvant treatment for patients with locally advanced but resectable rectal~     adenocarcinoma.~   "
153735|NCT01554046|"~     The purpose of this study is to investigate the familial response to Methylphenidate~     treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects~     development.~   "
153736|NCT01554033|"~     REGISTRY is a multi-centre, multi-national, prospective, observational study of Huntington's~     disease (HD) with a control group of volunteers. It is an open-ended study which will include~     as many eligible participants as willing to participate. The goal of the project is to~     collect longitudinal data on the phenotypical characteristics of HD gene mutation carriers~     regardless of whether they display clinical symptoms and signs of the disease and of~     individuals who are part of an HD family (irrespective of their mutation carrier status), in~     order to:~        -  obtain natural history data on a wide spectrum of HD mutation carriers and individuals~          who are part of an HD family~        -  relate phenotypical characteristics~             -  with genetic factors ('genetic modifiers')~             -  with data derived from the study of body fluids (blood, urine - 'wet biomarker')~               and~             -  imaging data ('dry biomarker')~        -  expedite identification and recruitment of participants for clinical trials~        -  develop and validate sensitive and reliable outcome measures for detecting onset and~          change over the natural course of premanifest and manifest HD which may also be~          potential outcome measures for use in future clinical trials and clinical care.~        -  plan for future research studies (observational and interventional trials aimed at~          better symptom control or aimed at slowing or postponing the onset and progression of~          HD).~   "
153823|NCT01552889|"~     This study compares the effects of depression screening and case management to usual care in~     cardiology outpatients with documented evidence of coronary heart disease. Despite strong~     evidence that depression is a risk factor for cardiac events, there is insufficient evidence~     to support the use of depression screening in cardiac patients.~   "
153738|NCT01554007|"~     In the past decade, the incidence and prevalence of CD (Crohn's disease) has continued to~     increase in Korea. Previous studies have indicated that Asian IBD (inflammatory bowel~     disease) patients differ from those of Western patients with regard to the genetic~     susceptibility and some clinical features. However, the available published data from~     retrospective studies in Korea were largely incomplete. The investigators aim of the study is~     a set-up of Korean cohort for CD, and thereby to assess the clinical course of Korean CD~     patients through a prospective multicenter long-term follow-up study. Secondary aims of this~     study are as follows: (1) to evaluate the efficacy, tolerability, and predictors to response~     to anti-TNF therapy for CD, (2) to identify the risk factors for postoperative recurrence on~     the basis of information obtained at initial diagnosis, and (3) to evaluate~     genotype-phenotype correlation.~   "
153739|NCT01553994|"~     Overview and rationale: Through Swedish health care registers it is possible vaccine~     effectiveness. The overall aim is to develop tools for fast and reliable evaluation of~     vaccines focusing on effectiveness. In this study the investigators will assess the~     population impact on condyloma prescribed drugs after HPV-vaccination and to estimate the~     economic burden of hospitalizations due to condyloma. Genital warts (condyloma) are one of~     the most common sexually transmitted diseases in Sweden, estimated 20 000 identified cases~     per year, and are primarily treated with Podofyllotoxin and Immiquimod. One of the approved~     HPV vaccines also protects against condyloma. In clinical trials, this vaccine is safe and~     highly efficacious (90-100%) against persistent infection with HPV 6 and 11 and genital warts~     in women and men. However, these results are from clinical trials and do not answer the~     question weather the vaccine works when delivered, as it would be in the real world. By~     linkage between the Svevac, the patient register and the Drug prescription register the~     investigators can estimate the effectiveness of the HPV vaccine in preventing cases of~     condyloma in a defined population.~      Method and execution: This is a retrospective collection of data from Swedish health care~     registries where the study population will consist of persons who are HPV-vaccinated as well~     as a non-HPV-vaccinated control group (identified through the population-based register,~     matched on sex, age and living area). The primary statistical analysis will be a calculation~     of prescriptions of condyloma treatments after vaccination compared to the non-vaccinated~     control group.~   "
153740|NCT01553981|"~     Systemic sclerosis (SSc, scleroderma) is a multisystem autoimmune rheumatic disease that~     causes inﬂammation, vascular damage and ﬁbrosis. Besides involvement of skin, fibrosis also~     affects lung and heart. Although advances in understanding in pathophysiology and use of~     immunosuppressive therapy has brought significant improvement in outcome of other autoimmune~     diseases, scleroderma still remains as a disease with high mortality and 10 yr survival rate~     has improved only from 54% to 66% during last 25 years1. The frequency of deaths due to renal~     crisis significantly decreased (mainly due to effectiveness of ACE Inhibitors), from 42% to~     6% of scleroderma-related deaths (p 0.001), whereas the proportion of patients with~     scleroderma who died of pulmonary fibrosis increased (due to lack of significant treatment)~     from 6% to 33% (p 0.001). However, presently, trials with immunosuppressive drugs including~     cyclophosphamide and other targeted molecules like Bosentan and Imatinib mesylate have shown~     very modest results at the best and given the risk of toxicity. The investigators have~     conducted three clinical trials with PDE5 inhibitor Tadalafil in the refractory Raynaud's~     phenomenon (RP) in SSc over last 3 years and had found good response in RP, healing of~     digital ulcers, prevention of new digital ulcers and also observed improvement in skin~     tightening, endothelial dysfunction and improvement of quality of life. The investigators~     therefore hypothesize that tadalafil may have an efficacy in improving the ILD of SSc.~      The investigators therefore design this double-blind, randomized, placebo-controlled trial of~     oral Tadalafil (20 mg alternate day) in patients with SSc having ILD. Patients will be~     randomly assigned in a 1:1 ratio to receive either Tadalafil or matched placebo and will be~     followed up for 6 months. Prednisolone (if required for indications other than ILD) will be~     allowed up to 10 mg/d in all patients. Patient/s requiring more than 10 mg/d of prednisolone~     or equivalent dose of steroid will be excluded from the study. Patients who will fail on~     therapy during the study will be excluded from the study and will be asked to choose any~     therapeutic option from the rescue protocol.~      Patients with FVC ≤ 70% predicted or DLCO ≤ 70 % of predicted, Evidence of ILD on HRCT will~     be enrolled. The primary objective of the study will be the change in FVC (expressed as a~     percentage of the predicted value) from baseline values at the end of 6-months of treatment.~     The secondary objectives will be improvement in dyspnea, improvement in 6 min walk distance,~     change in DLCO, change in total lung capacity, change in the disability index of the Health~     Assessment Questionnaire (S HAQ), and change quality of life (SF-36), levels of NT pro-BNP~     and fibrosis markers.~   "
153741|NCT01553968|"~     It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie~     insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus.~     Acetylcarnitine concentration is suggested to be a marker of such imbalance. It is expected~     that when TCA-cycle capacity is high (a high oxidative capacity), less acetylcarnitine will~     accumulate, because of an improved balance between supply and demand of lipids.~      The major research objective is to examine if acute exercise results in a more pronounced~     increase in acetylcarnitine concentration in sedentary subjects compared to endurance-trained~     subjects and if the exercise-induced increase in acetylcarnitine is restored more quickly in~     endurance-trained subjects when compared to sedentary subjects.~      The investigators hypothesize that the increase in acetylcarnitine levels will be lower in~     trained subjects when compared to sedentary subjects, due to a better balance between lipid~     supply and utilization by the TCA-cycle. Furthermore it is expected that acetylcarnitine~     concentrations will be restored faster in these trained subjects, because of a tighter~     regulation of influx of fatty acids.~      To test this hypothesis the investigators want to compare the acetylcarnitine response to~     exercise in a group of sedentary subjects and a group of endurance trained subjects. This~     response will be measured for 30 minutes after exercise with the use of 1H-MRS.~   "
153742|NCT01553955|"~     This is a device study in some respects, in that specialized centrifuges are commonly used to~     make platelet rich plasma, and we are studying the use of standard laboratory equipment to do~     so. However, it is primarily interventional in that we will evaluate the percentage success~     of trainees in the concentration of viable platelets to more than 4X baseline using a generic~     speed centrifuge and a single spin method.~   "
153754|NCT01553786|"~     This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by~     complete response rate at the end of treatment. Approximately 80 patients aged between 60 and~     80 years will be included, to have 70 evaluable patients. The treatment consists of two~     phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment~     duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be~     administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is~     taken for 14 days. Patients will be followed for at least 18 months after inclusion of the~     last patient.~   "
153824|NCT01552876|"~     This study is evaluating the initial fit of toric contact lenses.~   "
157761|NCT01501136|"~     The purpose of this study is to evaluate the efficacy and safety of DDGP regiment~     (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with newly diagnosed stage~     I/II Natural Killer (NK)/T Cell Lymphoma.~   "
153743|NCT01553942|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that study~     doctors are trying to find out more about it-such as the safest dose to use, the side effects~     it may cause, and if the drug is effective for treating different types of cancer. It also~     means that the FDA has not yet approved the drug for the patients type of cancer or for any~     use outside of research studies.~      Chemotherapy and radiation is the standard treatment for the patients with stage III~     non-small cell lung cancer (NSCLC). For people with epidermal growth factor receptor (EGFR)~     mutations, adding a type of drug called a tyrosine kinase inhibitor (TKI) can help increase~     the response to treatment.~      Afatinib is a tyrosine kinase inhibitor. It has been studied in a previous research study in~     participants with more advanced NSCLC. Results from that study indicate it may be helpful in~     treating NSCLC with EGFR mutations.~      In this study, patients with stage III NSCLC and EGFR mutations will receive the standard~     treatment of radiation and chemotherapy. If possible, the patients tumor will be removed by~     surgery. Afatinib will be given before radiation and chemotherapy and after surgery. The aim~     of giving afatinib before radiation therapy is to try to shrink the tumor. This may make the~     radiation therapy more effective since radiation therapy tends to work better on smaller~     tumors.~      The goal of this study is to see if adding afatinib to standard treatment helps to improve~     the response to treatment.~   "
153744|NCT01553929|"~     Regular physical activity is now recognized as a key element of good physical and mental~     health and this all ages.~      MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive~     training in improving the cognitive function of patients diagnosed with Mild Cognitive~     Impairment (MCI).~      DESIGN : Controlled randomized monocentric and prospective study with clinical benefit for~     the patient with three groups : one physical training and cognitive exercise group, one~     physical training without cognitive exercise group and one control group.~      In agreement with the literature on the effects of physiological stress on cognitive~     performance, the investigators expect the best cognitive test scores in groups with exercise~     training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD,~     depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire.~     Furthermore the investigators hypothesize that this positive effect is greater in the~     physical training and cognitive exercise group compared with the physical training group~     only.~   "
153745|NCT01553916|"~     This phase I/II trial studies the effects and safety of giving lithium carbonate (lithium) to~     patients with small cell lung cancer (SCLC) undergoing radiation therapy to the brain (PCI;~     prophylactic cranial irradiation). PCI is used to prevent cancer metastases from returning in~     the brain. This treatment can cause short-term memory problems by damaging the hippocampus.~     Lithium may help prevent or lessen memory problems caused by PCI by protecting the~     hippocampus.~   "
153746|NCT01553903|"~     This is a biomedical study of interventional type which includes 29 patients on 9 months: 8~     months recruiting and 1 month follow up.~      Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an~     indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will~     be enrolled in this study.~      The main objective of this study is to evaluate the feasibility for the determination of~     Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of~     treatment (ie, at D0 before and D28 after beginning of treatment).~   "
153747|NCT01553890|"~     The aim is to find the presence of anti vitamin D antibodies in scleroderma patients and~     compare with control. A second goal is anti vitamin D levels in serum of scleroderma patients~     in relation to the clinical manifestations of the disease.~   "
153748|NCT01553877|"~     The prevention of malnutrition among children under 5 years of age requires consumption of~     nutritious food, including exclusive breast feeding for the first six months of life,~     followed by breastfeeding in combination with complementary foods thereafter until at least~     24 months of age; a hygienic environment; access to preventive as well as curative health~     services, and good prenatal care. The proposed research is on the possible options for~     providing a nutritious diet, realizing the constraints of poverty and food insecurity faced~     by care givers whose children are at risk of developing or confirmed to be suffering from~     moderate malnutrition. Even when people are not typically food insecure but consume a~     relatively monotonous diet with few good-quality foods, they also have to have options for~     dietary improvement, and especially the possibility of ready-to-use complementary food~     supplements (RUCFS) for young children. This proposed research on development of RUCFS will~     pave the way for programmatic considerations for expansion of the use of new complementary~     food supplements for preventing malnutrition among young children in Bangladesh.~   "
153749|NCT01553851|"~     This phase II trial studies how trametinib effects tumor cells in patients with oral cavity~     squamous cell carcinoma that can be removed by surgery. Trametinib may shrink the tumor by~     blocking an enzyme pathway needed for cell growth.~   "
153750|NCT01553838|"~     The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher~     prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy~     in patients with increased PSA values > 4.0 ng/ml.~   "
153751|NCT01553825|"~     Assessing the mindset of cancer patients will help us better understand which patients are~     having difficulty dealing with the diagnosis and treatment that may not otherwise be fully~     appreciated by their physicians. By identifying such patients, we may then be able to design~     and implement strategies that can help improve their coping skills both during the treatment~     as well as after the completion of treatment. In addition to addressing physical concerns and~     symptoms, this approach will help address the overall emotional impact of a cancer diagnosis~     as more patients are living as cancer survivors.~   "
153752|NCT01553812|"~     The study hypothesize that parameters of new function machine---'forced oscillation~     technique' (FOT) can correlate well with the conventional lung function data for measurement~     of airway resistance and airtrapping in elderly COPD patients.~   "
153753|NCT01553799|"~     tracheal and endobronchial misplaced will be checked quickly qith US~   "
154053|NCT01549860|"~     This trial is a prospective, randomized, controlled, multi-center study of subjects~     presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and~     effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care~     (SOC) alone in the treatment of lower extremity venous ulcers.~   "
153755|NCT01553773|"~     The aim of this trial was to compare the effects of estradiol or genistein treatment on the~     hialuronic acid concentration on the postmenopausal facial skin. In this study, 30~     postmenopausal women were evaluated through a prospective, randomized, double-blind trial.~     The volunteers were postmenopausal women treated in the Gynecology Department of the Federal~     University of São Paulo (UNIFESP). The participants were divided into two groups: group E,~     treated with 17 β estradiol gel 0.01% (n = 15), and group G, treated with genistein gel 4 %~     (isoflavones, n=15). The length of treatment was 24 consecutive weeks. Preauricular skin~     biopsies were performed on each patient before and after the treatment for evaluating~     hyaluronic acid in the tissue. The materials were processed through immunohistochemical and~     biochemical methods.~   "
153756|NCT01553760|"~     The purpose of this study is to compare the use of an Anterior Chamber Maintainer (ACM) as~     the sole fluid source in phacoemulsification micro incision cataract surgery (using 1.1mm~     corneal incision) as opposed to conventional coaxial phacoemulsification (using 2.4mm corneal~     incision).~   "
153757|NCT01553747|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of different~     doses of JNJ-27018966 compared with placebo in the treatment of patients with~     diarrhea-predominant irritable bowel syndrome.~   "
153758|NCT01553734|"~     The macrolide group of antibiotics can cause QT prolongation, and endanger the patient with~     life threatening arrythmias. QT prolongation caused by Azythromycin, a relatively new~     macrolide, is extremely rare, and was not reported in clinical trials. Our hypothesis is that~     patients hospitalized with severe community acquired pneumonia, usually with multiple~     comorbid conditions will have a higher rate of QT prolongation, compared to the clinical~     trials published~   "
153759|NCT01553721|"~     This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy~     and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).~   "
153760|NCT01553708|"~     Partial thickness burn wounds are most likely to heal within 2-3 weeks mainly by mechanism of~     epithelialization. However, it depends on the depth of the wounds and patient condition.~     Infection is one of the most common complications causing delay in wound healing which might~     affect to quality of patient's life. Generally, the standard treatment of partial thickness~     burn wound is topical 1% silver sulfadiazine cream. Previous studies had been reported the~     broad spectrum antimicrobial activity of silver sulfadiazine cream but it did not demonstrate~     the accelerating effect of wound healing. Therefore, the combination of substance which can~     promote wound healing to topical silver sulfadiazine cream might benefit for partial~     thickness burn wound treatment.~      The objective of this study was to compare the results of partial thickness burn wound~     treatment at burn unit, Siriraj hospital with topical cream containing 1% silver sulfadiazine~     plus 6% epidermal growth factor (EGF) and 1% silver zinc sulfadiazine. The demographic data~     (age, sex, %body surface area burn), time of wound closure, pain and itching, dose and type~     of pain and itching medication, adverse effect of topical medication, some laboratory results~     and cost of expenses.~      This is the prospective, double blinded, randomize-controlled study. The sample sizes were~     partial thickness burn wound patients who were treated at burn unit, Siriraj hospital.~     Patients were allocated into 2 groups receiving treatment with either topical silver~     sulfadiazine plus EGF or silver zinc sulfadiazine. All parameter data were analyzed with~     repeated measure ANOVA and independent t-test.~   "
153761|NCT01553695|"~     ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5%~     of adults worldwide. This condition is under-recognised in France and other European~     countries and, therefore, under-diagnosed.~      As part of the European Network for Adult ADHD, the investigators translated into French a~     structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators~     also translated rating scales such as the ASRS and the WURS. Validation studies are rare in~     France.~      The aim of this study is to include two groups of 50 adults whether they have or not ADHD~     with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as~     implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to~     fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale~     (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a~     screening tool for ADHD in childhood with respect of the Utah criteria). The investigator~     will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the~     past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence~     of ADHD in adults will be computed.~   "
153762|NCT01553682|"~     Young African-American women who report a higher frequency of alcohol use have particularly~     higher rates of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV)~     sex behaviors. Unfortunately, there are no evidence-based HIV interventions designed to be~     gender- and culturally-appropriate for this population. To address this, the investigators~     propose to add to the CDC-defined evidence-based intervention (DEBI), Horizons, a new~     intervention form, Group Motivational Enhancement Therapy (GMET), which has shown promise in~     reducing alcohol use and alcohol-related HIV risk-taking. To test how effective the combined~     Horizons+GMET alcohol-specific portion is, it will be evaluated with a time equivalent~     Horizons+attention control general health promotion (GHP) portion focusing on nutrition~     health promotion, and to an enhanced standard-of-care program. In this study, 600 young~     African American women, 18-24 years of age, who report 3 or more occasions where they drank~     alcohol in the past 90 days will be recruited to complete a four-part baseline assessment~     consisting of: 1. an audio computer assisted self interview (ACASI), 2. videotaped~     communication role plays to objectively measure communication skill ability (subsample), 3.~     provide a vaginal specimen to test for STDs and 4. Provide a urine pregnancy screen. After~     participants complete their baseline assessment, they will be randomly assigned to one of~     three conditions: 1. Horizons+GMET alcohol-specific condition, 2. a time-equivalent~     Horizons+GHP condition, or 3. an enhanced standard-of-care control condition. The GMET~     alcohol-specific component has shown to be effective in influencing several alcohol-specific~     concepts (attitudes, norms, self-efficacy) and reducing sexual risk-taking among~     culturally-diverse high-risk youth. The GMET alcohol-specific module was designed to increase~     woman's awareness of the unfavorable effects of alcohol on themselves, their sexual~     decision-making, and their male partner and teaches women strategies to reduce the~     possibility of engaging in sex under the influence of alcohol. In addition, the GMET~     alcohol-specific module provides skills training needed to effectively talk about sexual~     intentions to use condoms and/or refuse risky sex when they or their male sex partner has~     been using alcohol. After completing one of the three conditions, participants will complete~     a brief ACASI posttest to evaluate immediate changes in hypothesized social and psychological~     mediators of safer sex and alcohol use. Participants will also return to complete follow-up~     assessments at 3, 6, 9, and 12-months after their intervention. If the Horizons+GMET~     intervention is observed to be effective, investigators will work closely with the CDC DEBI~     program to help distribute the intervention to public health agencies and community based~     organizations (CBOs).~   "
153796|NCT01553240|"~     This study uses functional brain imaging and noninvasive brain stimulation techniques to~     study the brain basis of developmental disorders like Autism Spectrum Disorder and Asperger~     Disorder. Functional magnetic resonance imaging (fMRI) and recently approved FDA treatment of~     depression, Transcranial magnetic stimulation (TMS) will be used to study the neurocircuitry~     of certain symptom clusters in developmental disorders.~   "
153763|NCT01553669|"~     The primary hypothesis is, comparing with the control group, reminiscence therapy is~     significantly and clinically effective to improve the experiment group's depressive symptoms~     after six weeks therapy, and the efficacy can be maintained on the three months follow-up.~      The secondary hypothesis is, comparing with the control group, reminiscence therapy~     significantly reduce the loneliness and increase the self-esteem and life satisfaction of the~     experiment group.~   "
153764|NCT01553656|"~     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics~     (PK), pharmacodynamics, pharmacogenomic (PGX) and preliminary efficacy following daily oral~     doses of cabozantinib (XL184) in Japanese patients with advanced or metastatic solid tumors.~     Also, the effect of XL184 in the treatment of non-small cell lung cancer (NSCLC) patients~     with various activating mutations will be evaluated at the recommended Phase 2 dose.~   "
153765|NCT01553643|"~     Intracranial arterial prominent stenosis (IAPS) is one of main cause of stroke especially in~     Asia. Although antiplatelet aggregative or anticoagulant agent and even surgical operation~     are used to treat patients with IAPS, the incidence of stroke occurrence still remains high.~     In addition, symptomatic IAPS most common cause continuous deterioration, thus, increase the~     incidence of stroke. Therefore, there is a good method to reduce the inceidence of stroke~     that is to prevent the progressive deterioration of IAPS.~      Huang-Chi-Wu-Wu-Tang is made of Astrgalus membranaceus (Fisch.) Gge , Paeonia lactiflora Pall~     , Cinnamom Twig , Zingiber officinale Rose , Ziziphus jujube Mill , and can treat hemiplegia~     in the traditional Chinese medicine writings. Astragaloside IV is a component of Astrgalus~     membranaceus, may reduce th cerebral infarction area in middle cerebral arterial occlusion~     mice. The investigators previous studies have known that paeoniflorin that a component of~     Paeonia lactiflora Pall can decrease the cerebral infarction area and neurological deficit in~     middle cerebral arterial occlusion rats. Therefore, the purpose of the present study was to~     investigate the effect of Huang-Chi-Wu-Wu-Tang on patients with IAPS.~   "
153766|NCT01553630|"~     Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and~     distal tibia are difficult to treat and typically have more complications than other~     metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures~     are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia~     treated with locked plates often have a critical sized fracture gap (poorly organized~     cortical pieces many of which are stripped of soft tissue). Optimal management strategies~     that minimize both fracture healing time and complication rates remain controversial. Primary~     bone grafts or early secondary bone grafts have been recommended for these comminuted open~     fractures, but have not been studied as the primary end point in a randomized trial. There is~     a need to study primary bone grafting during open reduction and internal fixation (plating)~     of these difficult fractures, to determine if shorter healing time, and thus less need for~     reoperation, can be achieved.~      Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and~     radiographic union with a lower need for secondary procedures~   "
153767|NCT01553617|"~     The study will compare the efficacy and safety of VolulyteTM and human albumin in elective~     open-heart surgery in adult patients.~   "
153768|NCT01553604|"~     This study was designed to determine whether the duration of dressing wear following~     augmentation mammaplasty influence skin colonization and eventually surgical site infections~     rates.~   "
153769|NCT01553591|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of different~     doses of JNJ-27018966 compared with placebo in the treatment of patients with~     diarrhea-predominant irritable bowel syndrome.~   "
153770|NCT01553578|"~     This randomized clinical trial studies healing touch or guided imagery in treating pain,~     fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided~     imagery may help treat complications caused by chemotherapy. It is not yet known whether~     healing touch or guided imagery is more effective in treating pain, fatigue, nausea, and~     anxiety in patients undergoing chemotherapy~   "
153771|NCT01553565|"~     1. Background: The ideal method to remove small colorectal polyps in patients who are~          taking antithrombotic agents is unknown.~        2. Aim: The aim of this study is to evaluate postpolypectomy bleeding and the complete~          retrieval rate after the removal by colon snare transection without electrocautery for~          small polyps in patients who are taking antithrombotic agents.~        3. Design: A prospective, consecutive study.~        4. Setting: Municipal hospital outpatients.~        5. Interventions: Polypectomy by cold snare technique (Cold polypectomy) was performed for~          colorectal polyps up to 10 mm in diameter in patients who continue to take~          antithrombotic agents. The primary outcome measure was bleeding within two weeks after~          polypectomy. Secondary outcome measure was the complete retrieval rate of colorectal~          polyps based on the pathological examination.~   "
153772|NCT01553552|"~     SchistoVAN aims to study the role of schistosomiasis infection in the modulation of the~     immune response of children to childhood vaccine antigens, as well as the impact of this~     infection on their nutritional status and their haemoglobinaemia.~   "
153773|NCT01553539|"~     This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line~     therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be~     removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking~     blood flow to the tumor.~      Funding Source - FDA Office of Orphan Drug Products (OOPD)~   "
153774|NCT01553526|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
153803|NCT01553149|"~     This randomized phase II trial studies how well low-dose lenalidomide works compared with~     high-dose lenalidomide in treating younger patients with juvenile pilocytic astrocytomas or~     optic nerve pathway gliomas that have come back (recurrent), have not responded to treatment~     (refractory), or are growing, spreading, or getting worse (progressive). Lenalidomide may~     stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known~     whether low-dose lenalidomide is more or less effective than high-dose lenalidomide in~     treating patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas.~   "
153804|NCT01553136|"~     The purpose of this study is to determine whether varenicline is effective in the treatment~     of alcohol dependence in smokers.~   "
153775|NCT01553513|"~     This is a single-centre prospective trial with 140 patients employing~     [18F]-fluorodeoxyglucose positron emission computed tomography (FDG PET/CT) and advance~     motion correction and image fusion algorithms to create motion frozen displays and quantify~     FDG-uptake and thus inflammatory activity in atherosclerotic plaques in the coronary tree.~     Four groups of patients, two with stable coronary artery disease and two with acute coronary~     syndrome will be compared and the results of FDG PET/CT will be correlated to results of~     invasive coronary angiography, intravascular ultrasound / virtual histology, patient risk~     profile and serum markers of inflammation.~      The investigators hypothesize that increased FDG accumulation in atherosclerotic plaques~     shows a positive correlation with inflammatory activity in coronary plaques and markers of~     plaque vulnerability as well as the risk profile of the patients and serum markers of~     inflammation. The investigators furthermore hypothesize that FDG PET/CT is able to detect~     high risk patients and provide an important means for risk stratification and optimization of~     patient management.~   "
153776|NCT01553500|"~     Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly~     becoming the one of most common causes of chronic liver disease in children. The pathogenesis~     of NAFLD is generally considered the result of a series of liver injuries, commonly referred~     as multi-hit hypothesis. Insulin resistance and increased serum levels of free fatty acids~     (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in~     hepatocytes resulting in steatosis.~      Has been reported that a diet rich in high-viscosity fiber improves glycemic control and~     lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.~      Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children~     affected by non alcoholic fatty liver disease.~   "
153777|NCT01553487|"~     The aim of the present study is to investigate the effects of vibrating the forearm bone in~     the free limb on muscle strength and bone mineral density of the forearm in patients with~     forearm/elbow fracture.~      A total of 80 patients with forearm/elbow fracture are planned to include in this study.~     Patients will be randomly attained Training or Control group. Training period will be six~     weeks. Patients in the control group will receive standard care for provided for fractures,~     including fixation and rest.Before the start of the study and after six weeks, bilateral bone~     density of distal radius will be measured by DXA. Before trials, grip strength and the rest~     muscle electrical activity of contralateral wrist flexors and extensors will be measured.~     After six weeks, bilateral grip strength and the rest muscle electrical activity will be~     measured.~   "
153778|NCT01553474|"~     Background:~      - The Age-Related Eye Disease Study 2 (AREDS 2) is looking at different eye diseases. Study~     participants will provide blood and saliva samples. The samples will be stored for research~     on eye diseases.~      Objectives:~      - To collect blood and saliva samples for AREDS 2 research.~      Eligibility:~      - AREDS 2 research study participants.~      Design:~        -  Participants will provide blood and saliva samples.~        -  The samples will be submitted with personal and medical information. This information~          will be collected during the AREDS 2 procedures.~   "
153779|NCT01553461|"~     Background:~      - Cord blood transplants can treat cancers and other diseases in children and adults. The~     U.S. Food and Drug Administration (FDA) requires cord blood to be collected and stored under~     certain safety standards. However, most available cord blood units were collected before the~     FDA set these standards. These units may not meet FDA standards, but they do meet similar~     standards set and followed by the National Marrow Donor Program (NMDP). Cord blood units that~     do not meet the new FDA standards may be used for transplants only as part of a research~     study. Doctors want to allow people who need transplants to receive cord blood that meets~     NMDP standards but may not meet FDA standards.~      Objectives:~      - To allow selected cord blood units that do not meet current FDA standards to be used for~     transplant.~      Eligibility:~      - Individuals who need cord blood units for transplant, and who best match cord blood units~     that are not FDA-licensed.~      Design:~        -  Participants will provide consent to receive cord blood that meets NMDP standards but~          may not meet FDA standards.~        -  Participants will remain on the study for observation for up to 1 year after transplant,~          or until they withdraw from the study for personal or medical reasons.~   "
153780|NCT01553448|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies gene expression in samples from younger patients with~     neuroblastoma.~   "
153781|NCT01553435|"~     Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods~     analgesia and tolerance in Pediatric Intensive Care Unit Patients~   "
153782|NCT01553422|"~     This study assess the relation between intra abdominal pressure and collapsibility index of~     inferior vena cava in emergency bedside ultrasonography before and after fluid therapy.~   "
153783|NCT01553409|"~     The investigators want to investigate the effects of blood donation to blood pressure, to~     iron metabolism and oxidative stress.~      There are results of other studies that show, that there is a positive effect of blood~     donation to high blood pressure, iron metabolism and oxidative stress.~   "
153784|NCT01553396|"~     This study shows an evaluation of the correlation between the muscle strength levels and~     functional autonomy of elderly women.~   "
153785|NCT01553383|"~     Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime~     sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP)~     valve Provent in obstructive sleep apnea. The hypothesis is the efficacy will be better~     than dental device.~   "
153805|NCT01553123|"~     The purpose of this study is to determine whether ulipristal acetate is effective in the~     treatment of females with anemia associated with uterine leiomyomas. The safety of this~     product will also be evaluated.~   "
153806|NCT01553110|"~     This is a study to learn more about the common cold from studying the nasal secretions~     produced during a cold or episode of allergic rhinitis.~   "
153807|NCT01553097|"~     This longitudinal project will investigate a common complaint of women who receive~     chemotherapy for breast cancer- cognitive difficulty. The relationships of fatigue, stress,~     and depression to cognitive difficulties will be examined. The findings should lead to~     interventions to decrease the effects of these problematic side effects.~   "
153786|NCT01553370|"~     Maintaining a healthy body weight is a major challenge for the majority of Canadians. A~     lifestyle strategy that promotes maintenance of a healthy body weight and, perhaps most~     importantly, can be incorporated into daily life with relative ease is essential. This study~     will determine if an effective strategy includes increased physical activity in conjunction~     with higher intakes of dairy products immediately following exercise. Fifty-six overweight~     adult males who do not regularly exercise will be assigned to one of four groups for 12~     weeks. All groups will preform 12 weeks of exercise training (1 hour of cycling per day, 5~     times per week). Two groups will consume supplemental low fat milk (3 servings per day) with~     one these groups consuming it immediately after exercise while the other will consume it~     either well before or long after the exercise session. The other two groups will consume a~     carbohydrate drink that has the same amount of energy as the low fat milk, with one of these~     groups consuming the drink right after exercise and the other another group will consume it~     either well before or long after the exercise session. Markers of health status including~     body weight, muscle mass, and bone mass will be measured at the start and after the 12- week~     intervention. The investigators anticipate that providing the low fat milk immediately after~     exercise will result in the most favorable changes in health outcomes, and provide a~     realistic lifestyle intervention for overweight individuals to attain a healthy body weight,~     and by doing so, optimize their ability to prevent chronic disease.~   "
153787|NCT01553357|"~     This is an open label, multicenter, exploratory, single arm, two-stage study aiming to~     explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line~     therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).~   "
153788|NCT01553344|"~     The aim of this study is to determine serum sclerostin levels and change in serum sclerostin~     levels in patients with Vitamin D deficiency treated with calcium and vitamin D.~      Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with~     calcium and vitamin D will be included in the study. This is an observational study. The~     serum sclerostin levels will be measured before and after Vitamin D treatment.~   "
153789|NCT01553331|"~     Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting~     at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another~     option. The aim is to test the hypothesis that with ultrasonic dissection technique a better~     same day discharge and a shorter operative time can be achieved.~   "
153790|NCT01553318|"~     The purpose of this 10-week study is to determine the effects of a medication called~     Ketotifen on pain sensitivity; and fibromyalgia-related pain.~      Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that~     are known to cause inflammation. It is an antihistamine that reduces the harmful effects of~     histamine. The ophthalmic (eye drops) formulation of ketotifen has been approved by the Food~     and Drug Administration (FDA) and has been available in the United States for more than a~     decade. Oral (taken by mouth) ketotifen has been in available in other countries for several~     decades. Commonly prescribed for the maintenance treatment of asthma and allergic rhinitis,~     ketotifen has long track record of safety. To date, the oral form of ketotifen has not been~     approved by the FDA, therefore this study is referred to as an investigational drug study.~     Prior to opening recruitment an investigational new drug (IND) application which included~     scientific data and information regarding human safety plans was submitted to and approved by~     the FDA.~   "
153791|NCT01553305|"~     The purpose of this study is to compare the effectiveness of a supervised high-intensity~     exercise programme followed by an unsupervised exercise programme to an unsupervised exercise~     programme in patients with Rheumatoid Arthritis.~   "
153792|NCT01553292|"~     Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called~     ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is~     needed to adapt the use of large volume surfactant of 4-5 ml/kg.~      The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada~     called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation~     suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on~     CPAP.~   "
153793|NCT01553279|"~     Primary objective~      • To evaluate the concomitant administration of PR5I with two types of MCC vaccines (MCC-TT~     and MCC-CRM)~      Secondary objectives~      Part I~        -  To describe the immunogenicity of PR5I when PR5I is given at 2 months of age and~          concomitantly with MCC vaccines at 3 and 4 months of age~        -  To describe the immunogenicity of MCC vaccines when MCC vaccines are given concomitantly~          with PR5I at 3 and 4 months of age (post-dose 1 and post-dose 2)~        -  To describe the safety of PR5I given concomitantly with PCV-13 and MCC vaccines~      Part II~      • To describe the immunogenicity and safety of Hib-MCC when given at 12 months of age in~     subjects who have received PR5I at 2, 3 and 4 months of age~   "
153794|NCT01553266|"~     The purpose of this study is to evaluate the implementation of the Mobile Diabetes Education~     Team (MDET) intervention in the Greater Toronto Area, as well as the intervention's~     effectiveness in improving patient clinical and care process outcomes.~      The study's hypotheses are that the MDET intervention results in the following outcomes:~        -  Improvement in patient clinical outcomes;~        -  An increase in the proportion of primary care physicians (PCPs) performing patient care~          processes according to clinical practice guidelines;~        -  An increase in the proportion of referrals to, and patients' utilization of, diabetes~          education programs (DEPs).~   "
153795|NCT01553253|"~     Chronic Pain is a wellknown complication after cholecystectomy. Intensity of the pain in the~     first week after the operation is a predictive factor for the development of chronic pain,~     but it is unknown whether the risk is more related to one of the different components of~     acute pain (ie somatic, visceral, referred). Furthermore the chronic pain has not been~     systematically described in terms of type of pain or sensory abnormalities etc. (allodynia,~     hyperalgesia etc.).~      The purpose of the study is to examine whether intensity of components of acute pain is~     predictive for development of chronic pain after cholecystectomy and to characterize the~     chronic pain by quantitative sensory testing.~      DNA-samples are collected to examine genetical factors, important for perception of pain, and~     the development of chronic pain.~   "
154054|NCT01549847|"~     This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue~     and muscle pain in patients with Postpoliomyelitis Syndrome.~   "
153797|NCT01553227|"~     Sleep Apnea Hypopnea Syndrome (OSAHS), is common in patients with OHS, compared to single~     Obesity Hypoventilation Syndrome (OHS) or OSAHS ,patients with both of them are more~     susceptible to have serious hypoxia and carbon dioxide retention during sleep, and much more~     likely to result in pulmonary hypertension and cor-pulmonale.~      At present, the most widely and valid method for these patients is the Bilevel Positive~     Airway Pressure (BiPAP) ventilation, while, recently, the investigators discovered a~     completely novel device, namely auto-trilevel Ventilator. In contrast to the traditional~     therapy, auto-trilevel Ventilator has a more flexible expiratory positive airway pressure~     (EPAP), with which it can removing residual obstructive sleep apnea hypopnea events and~     correcting hypercapnia without contradiction. Treated with auto-trilevel ventilator may delay~     the progression of disease and improve life quality. The overall purpose of this study is to~     determine the curative effects of auto-trilevel ventilators on patients with OHS and OSAHS.~   "
153798|NCT01553214|"~     Background:~      - White blood cells called granulocytes help the body fight infection. People who have had~     chemotherapy or bone marrow transplants may have very low numbers of these cells.~     Transfusions of these cells can help improve the body's ability to fight infection. However,~     most of the cells are located in the bone marrow or spleen, and are hard to collect from~     healthy donors. Two drugs, filgrastim and dexamethasone, can help move the cells to the~     bloodstream to be collected by apheresis. Researchers want to study the best ways to collect~     these white blood cells. They also want to monitor the effects of the injections and~     donations on the volunteer donors.~      Objectives:~      - To improve the amount and quality of granulocytes (white blood cells) collected by~     apheresis for donation.~      Eligibility:~      - Healthy volunteers between 18 and 75 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Initial blood~          tests will be done to check for eligibility.~        -  Participants will donate granulocytes by apheresis a maximum of 12 times in 1 year.~          Donations will not usually be requested more often than every 4 weeks. Donors will be~          allowed to decline participation at any time.~        -  Participants will have one injection of filgrastim 12 to 24 hours before donation. They~          will also have two tablets of dexamethasone 12 hours before donation.~        -  White blood cells will be collected through apheresis. The apheresis will last about 2~          hours.~        -  Participants will be eligible to donate until they reach their 76th birthday.~   "
153799|NCT01553201|"~     Background:~      - Some women with endometriosis have chronic pelvic pain. This pain may be caused by spasms~     of the pelvic floor muscles. These spasms can be detected by an examination. Studies suggest~     that botulinum toxin can help treat problems caused by muscle spasms. Researchers want to see~     if botulinum toxin injections into the pelvic floor muscles can decrease pain and spasms in~     women with pelvic pain.~      Objectives:~      - To see if botulinum toxin can relieve pain from pelvic floor spasm in women with pelvic~     pain.~      Eligibility:~      - Women between 18 and 50 years of age with pain associated with pelvic muscle spasm and~     endometriosis. Pain must be persistent (lasting for at least 3 months).~      Design:~        -  Participants will keep a pain diary and record their pain medication use for a month~          before the first visit.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Participants will also answer questions about their pain~          levels and quality of life.~        -  Participants will receive either botulinum toxin or a placebo (salt water) injection.~          The injection will be given into the pelvic floor muscles through the vaginal wall.~          Participants will take a muscle relaxant like Valium and have anesthetic cream put on~          the vaginal wall before the injection.~        -  After the injection, participants will keep a pain diary for another month.~        -  At a 1-month followup visit, participants will answer questions about their pain. If the~          pain has not improved, all participants may have a botulinum toxin injection (no~          placebo) into the pelvic floor muscles as before.~        -  Participants will have followup visits for up to a year after the initial 1-month~          followup visit.~   "
153800|NCT01553188|"~     Background:~        -  Advanced prostate cancer is treated with surgery or drugs that lower the levels of~          androgens (male hormones) in the body. However, some cancers become resistant to this~          treatment. These types of cancers are known as castration-resistant prostate cancers.~        -  Interfering with the growth of blood vessels that feed tumors can slow prostate cancer~          growth. AMG 386, a new anticancer drug, targets the blood vessels that feed tumors. It~          has been tested for different types of cancer, but not for prostate cancer. Researchers~          want to see if AMG 386 can slow disease progression in men with castration-resistant~          prostate cancer. AMG 386 will be given with abiraterone and prednisone, two drugs that~          are also used to treat advanced prostate cancer.~      Objectives:~      - To test the safety and effectiveness of AMG 386 with abiraterone for castration-resistant~     prostate cancer.~      Eligibility:~      - Men at least 18 years of age with castration-resistant prostate cancer.~      Design:~        -  Participants will be screened with a physical exam, medical history, and imaging~          studies. Blood and urine samples will also be collected.~        -  Participants will be separated into two groups.~        -  The first group will have AMG 386 once per week for a total of four doses during a~          28-day cycle. They will also take abiraterone once a day and prednisone twice a day,~          every day of the cycle.~        -  The second group will not have AMG 386. They will take abiraterone once a day and~          prednisone twice a day, every day of the 28-day cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the study drugs as long as the disease does not~          progress and there are no severe side effects.~   "
153801|NCT01553175|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and find biomarkers related to~     cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies gene expression in samples from patients with rhabdoid~     tumors.~   "
153802|NCT01553162|"~     RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples~     from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.~   "
154055|NCT01549834|"~     This is an efficacy and safety study evaluating a new treatment for subjects with mild to~     moderate Alzheimer's disease.~   "
153808|NCT01553084|"~     The overall purpose of this research is two-fold. First, the two smoking cessation medication~     treatments with the strongest evidence of effectiveness have never been directly compared.~     This research will determine how these two treatments compare in effectiveness in a~     head-to-head trial, and which types of smokers benefit most from each. Second, much of the~     data on smoking and health come from studies from many years ago. Today's smokers differ from~     earlier smokers in many ways that could influence the impact of smoking on health (e.g.,~     weight, sex, diet, socio-economic status); the proposed work will determine how smoking~     cessation affects cardiovascular and pulmonary health in today's smokers.~   "
153809|NCT01553071|"~     In preclinical studies, the anti-cancer efficacy of fenretinide, a synthetic retinoid that~     causes cytotoxicity by mechanisms which include increased intracellular dihydroceramides, has~     been shown to be enhanced by safingol, a stereochemical-variant dihydroceramide precursor.~     This phase I study represents the first clinical trial employing this promising combination.~     The drug administration schedule (fenretinide given on Days 1-5, safingol given on Days 1-2~     of each 21-day cycle) reflects the in vitro observation that tumor cell exposure to safingol~     increased fenretinide efficacy both during and after safingol administration. The total dose~     of fenretinide, 4600 mg/m2 over 5 days, represents a 30% total dose reduction from the single~     agent MTD dose of 1280 mg/m2/day x 5 days determined on the PhI-42 study. This fenretinide~     dose is expected to produce plasma levels in the 30?s ?M. This dose reduction has been~     employed to reduce the potential for overlapping hepatic toxicities between these two agents.~      The administration of a reduced fenretinide dose on Day 1 (600 mg/m2 on Day 1, escalated to~     1000 mg/m2/day on Days 2-5) has been selected due to earlier observations that initial~     exposure to the soy bean oil vehicle in the fenretinide emulsion may induce endogenous~     lipases, thereby permitting tolerance of higher total doses fenretinide emulsion subsequently~     administered. The starting dose of safingol in this study, 210 mg/m2/day x 2 days (420 mg/m2~     total), corresponds to 50% of the recommended Phase II safingol dose (bolus) determined in~     the Schwartz, et al, Phase I study of safingol plus cisplatin 60 mg/m2 (the MTD of~     single-agent, intravenous (emulsion) safingol was not reached in the Phase I safingol run-in~     monotherapy portion of this study), and was selected to provide an adequate safety margin~     against the potential for overlapping toxicities (such as hepatic transaminitis).~      The study has been designed to optimize the safety of this novel combination. Treatment will~     be administered in the inpatient setting. Central venous access will be mandated to avoid the~     potential for hemolysis and thrombophlebitis associated with the preclinical peripheral~     administration of a previous safingol formulation in rats. To reduce the incidence of~     hypertriglyceridemia, a revised fenretinide delivery schedule will be employed. Patients will~     also be encouraged to maintain a low-fat diet during fenretinide administration. Serum~     triglycerides will be monitored every 12 hours. To monitor for cardiac toxicity, which was~     noted in canine studies at the highest dose of safingol plus fenretinide tested, serum~     troponin T levels will be monitored daily. To limit the potential for hepatotoxicity~     resulting from a possible drug interaction observed between intravenous fenretinide,~     ceftriaxone and acetaminophen in a pediatric patient, the concurrent administration of~     ceftriaxone, or acetaminophen, with the fenretinide emulsion infusion will be prohibited.~   "
153810|NCT01553058|"~     The purpose of this study is to assess the effect of adalimumab (Humira), when compared to~     NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may~     resemble an active substance but has no medical value) injection. The study will compare the~     effects of each on systemic inflammation and cardiovascular disease risk factors in subjects~     diagnosed with moderate to severe psoriasis.~      This study will look for systemic vascular inflammation in subjects with a test called~     FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study~     will also look for cardio metabolic (heart disease and metabolic factors such as diabetes)~     identifiers in the blood. A blood sample will be taken that will look for these markers~     identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move~     in the body), metabolic factors, and inflammation.~      This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB~     phototherapy or placebo injection on psoriasis activity and severity. The study will also~     compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This~     study will also evaluate subjects' reported outcomes through a questionnaire that will assess~     quality-of-life in subjects living with psoriasis.~   "
153811|NCT01553045|"~     Atrial fibrillation is the most common cardiac arrhythmia. There is a large variation in~     symptoms; from almost none to severe but the reason for this is unclear.~      The investigators aim to find correlations between symptom burden and intracardiac pressure,~     biomarkers and findings with echocardiography in order to find alternative means of~     treatment.~      It is even intended to study the neurohormonal activation directly after the atrial~     fibrillation (AF) initiation in patients eligible for AF radiofrequency ablation.~   "
153812|NCT01553032|"~     This is a national multicenter phase IV study to assess acute radiation dermatitis of~     combined radioimmuno(chemo)therapy with Cetuximab in patients with locally advanced,~     non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).~   "
153813|NCT01553019|"~     The purpose of this study is to find out what effects, good and/or bad, proton radiation~     combined with chemotherapy has on resected pancreatic cancer.~   "
153814|NCT01553006|"~     Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about~     the efficacy of this drug at low and high doses.~   "
153815|NCT01552993|"~     The aim of this study is to see if paracetamol has a pain-relieving effect during eye~     examination in premature infants.~   "
153816|NCT01552980|"~     This is an open-label, phase II study to evaluate the efficacy and safety of a modified~     regimen of oxaliplatin and S-1 on unresectable gastric adenocarcinoma in the first-line~     therapy.~   "
153817|NCT01552967|"~     This is an open-label, phase II study to evaluate the efficacy and safety of a modified~     regimen of oxaliplatin and capecitabine on metastatic colorectal adenocarcinoma in the~     first-line therapy.~   "
153818|NCT01552954|"~     Purpose of this study~        1. Intensive education for low salt diet will be enhance the anti-proteinuric effect of~          Olmesartan, a popular anti-hypertensive drug of angiotensin II receptor blocker, in~          Koreans compared to conventional prescription of medication.~        2. Intensive education for low salt diet will decrease the amount of 24 hour-urine sodium~          excretion compared to control group, effectively.~   "
153819|NCT01552941|"~     This is a 12 week open label pilot study to determine the efficacy and safety of a surgically~     implanted, electrically active vagal nerve stimulation device in patients with active~     rheumatoid arthritis.~   "
153820|NCT01552928|"~     According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated~     for their ability to prolong the QT interval which represents the duration of ventricular~     depolarization and subsequent repolarization. The primary objective of the study is to assess~     the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose~     of anagrelide when compared to placebo and a positive control.~   "
153821|NCT01552915|"~     The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in~     adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).~   "
153822|NCT01552902|"~     The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in~     adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).~   "
153825|NCT01552863|"~     This is an open-label (both the physician and healthy volunteer know which medication will be~     administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of~     oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated~     by the body). This study will consist of three parts that will take place over approximately~     90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period~     each.~   "
153826|NCT01552850|"~     To estimate the pharmacokinetics and relative bioavailability of oxycodone after~     administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution~   "
153827|NCT01552837|"~     The aim of the study was to determine the pharmacological induced equivalents of neurogenesis~     and synaptic sprouting in the hippocampus, localized volume changes, changes in water content~     and neurochemical changes in the medial temporal regions.~   "
153828|NCT01552824|"~     There are two options of fetal treatment in cases of severe lower urinary tract obstructions:~     the vesico-amniotic shunting and fetal cystoscopy. There is no study confirming the~     effectiveness of these treatment, specially comparing both techniques. The present study aims~     to investigate the effectiveness of these treatments.~   "
153829|NCT01552811|"~     This study investigates the hypothesis that differences in beta-cell mass in patients with~     diabetes and healthy individuals can be monitored by the positron emission tomography (PET)~     tracer [11C]5-hydroxytryptophane.~   "
153830|NCT01552798|"~     The purpose of this trial is to determine if a single, oral dose of a fast release aspirin~     1000 mg provides relief compared to acetaminophen 1000 mg and placebo in subjects with~     tension-type headache pain.~   "
153831|NCT01552785|"~     A comparison of three different devices using near infrared spectroscopy to measure the~     regional oxygenation. Both absolute values, reproducibility of measurements and sensitivity~     to changes will be estimated. The study hypothesis is that NONIN EQUANOX 7600 with sensor~     Model 8004CA, INVOS 5100c with sensor SAFB-SM and FORE-SIGHT with medium sensor have similar~     characteristics.~   "
153832|NCT01552772|"~     This study will test the safety of an aripiprazole injection in subjects with schizophrenia~     that are currently taking oral antipsychotic medication other than aripiprazole. Subjects in~     this study will receive one injection of aripiprazole and will need to stop taking their~     other antipsychotic medication two weeks after the injection. The study will last one month.~     Subjects will be required to come to a clinic for evaluations and drug and urine collection~     five times during the course of the study.~   "
153833|NCT01552759|"~     This study investigates the hormones that the body produces in response to food intake and in~     response to stress, and the way that stress influences food intake. In particular, it~     compares the hormone levels and food intake of people with and without binge eating disorder.~     In order to find out how these appetite- and stress-related hormones are linked to brain~     activity, the study also includes an fMRI scan, a non-invasive procedure that looks at which~     regions of the brain are most active during a food-related scenario.~   "
153834|NCT01552746|"~     Shoulder pain is a well known problem after thoracical surgery. The pathogenesis of the pain~     is uncertain, but mainly a mix of referred pain and mechanical strain to the shoulder. It is~     believed to last a few days. Persisting shoulder pain after thoracical surgery is a problem 1~     year after surgery, but it is unknown if it is related to acute postoperative shoulder pain.~      The purpose of the study is to systematically describe postoperative shoulder pain after~     lobectomy and examine the time progress up to 1 year after surgery.~   "
153835|NCT01552733|"~     Weakness and impairment of the upper limb is a common contributing factor to post stroke~     disability. Specially designed robotic systems have been developed to try to improve this.~     The investigators already know that their use helps improve limb function after stroke when~     it has been present for many months. The investigators do not know whether they can help~     early after stroke and enhance recovery of limb function, and perhaps prevent weakness~     becoming chronic.~      The investigators plan a randomised controlled blinded study to explore the benefits of robot~     assisted therapy early after stroke in 80 stroke survivors. Participants will be randomised~     by 7 days after stroke to standard care or to robotic therapy (40 participants per study~     group).~      Standard of care will be rehabilitation therapy according to local guidelines delivered by~     NHS multidisciplinary team.~      Robotic therapy sessions lasts approximately one hour and consists of a series of tasks in~     first the unimpaired then impaired limb. The robotic-assisted therapy will consist of a~     series of taks including circle-drawing, reaching targets and holding/moving against moderate~     resistance. Twelve sessions of therapy within the first 4 weeks after randomisation will be~     delivered. This study will take 3 years to complete.~   "
153836|NCT01552720|"~     Data reported by the international registry of acute aortic dissection (IRAD) in not~     sufficient to reflect clinical characteristics of acute aortic dissection in China. Moreover,~     clinical characteristics of Acute aortic dissection have not evaluated to data. The aim of~     this study is analyze changing trend of clinical characteristics of Chinese patients with~     acute aortic dissection.~   "
153837|NCT01552707|"~     The present prospective, randomized study, compares the spinal fusion obtained after~     instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from~     his/her own bone marrow which will be fixed in human bone tissue form a donor), with the~     current procedure that consists in instrumented spinal fusion and the use of each patient's~     bone obtained from his/her iliac crest.~      The working hypothesis proposes that the tissue engineering is a valid and useful technique~     to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its~     associated morbidity.~   "
153838|NCT01552694|"~     People living with human immunodeficiency virus infection (HIV) have 2-4fold greater risk for~     developing diabetes and heart disease than the general population. They need safe and~     effective treatments that reduce the risk for developing diabetes and heart disease, and~     improve their quality of life. This project will explore whether a new anti-diabetes~     medication (Januvia) with a novel mechanism of action reduces inflammation, and improves~     blood vessel function in HIV infected men and women with several risk factors for developing~     cardiovascular disease.~   "
154105|NCT01549171|"~     Human fallopian tube secretes high concentration of prostacyclin. Fallopian tube is the site~     for early embryo development. The effect of prostacyclin on human early embryo development is~     waiting to be clarified. The study hypothesis is prostacyclin can enhance early embryo~     development.~   "
153839|NCT01552681|"~     The purpose of the study is to find out if the experimental study agent, baminercept, is~     effective in treating patients with Sjögren's syndrome. The study will also determine if the~     study agent can be safely given to patients with Sjögren's syndrome; examine how it affects~     symptoms of the disease; and attempt to understand how baminercept affects the underlying~     mechanisms of Sjögren's syndrome and the immune system.~   "
153840|NCT01552668|"~     The purpose of this research study is to evaluate the effectiveness of an antibiotic called~     fidaxomicin in preventing C. difficile infection.~   "
153841|NCT01552655|"~     The purpose of this study is to elucidate the value of dual-time-point PET/CT in the~     recurrence of breast cancer and to determine whether the method is better than the modalities~     used in the standard work up.~      150 patients with suspected breast cancer recurrence will be included. All patients will~     undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After~     completion of the examinations the early and the late PET/CT scan will be compared with each~     other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious~     findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained,~     the presence of recurrence will be verified with additional imaging follow-up to ensure the~     highest possible confidence. Sensitivity, specificity, accuracy, negative and positive~     predictive value (NPV/PPV) will be calculated for each modality (incl. early and late~     PET/CT).~   "
153842|NCT01552642|"~     The overall purpose of this study is to develop and implement an effective intervention~     program designed to prevent and treat obesity in young children.~   "
153843|NCT01552629|"~     The study will assess the safety and efficacy of QGE031 in the treatment of moderate to~     severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured~     and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of~     the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already~     established as being effective in atopic dermatitis.~   "
153844|NCT01552616|"~     Critically-ill patients who have long stays in the hospital often face prolonged periods of~     bed rest. It is known that these patient develop profound weakness and debilitation. The~     effectiveness of existing muscle activation devices that could otherwise prevent the onset of~     debilitation in an immobilized patient has not been demonstrated widely in this cohort. It is~     hypothesized that using thermal methods to augment existing muscle activation techniques may~     demonstrate improved performance with no corresponding change in the safety profile.~   "
153845|NCT01552603|"~     The purpose of this study is to verify an automated system of blood glucose control in Type I~     Diabetics. The automated system consists of the investigational Artificial Pancreas Control~     software (APC), two blood glucose sensors, and two hormone pumps, one for delivering insulin~     to lower blood sugar, and the second for delivering glucagon to raise blood sugar. The blood~     glucose sensors relays information to the Artificial Pancreas software, which uses the~     Adaptive Proportional Device algorithm to determine the rate of insulin and glucagon infusion~     by the hormone pumps. In prior studies, the Adaptive Proportional Device algorithm has been~     verified, but required manual input into the computer and hormone pumps. This study differs~     in that it uses a fully automated system under the control of the Artificial Pancreas Control~     software. The importance of this change is that it is the next step to enable outpatient use~     of automated, closed loop blood glucose control.~   "
153846|NCT01552590|"~     This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum~     sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and~     hyponatremia~   "
153847|NCT01552577|"~     The purpose of this study is to develop and validate eye-tracking measures that can be used~     to evaluate neurocognitive dysfunction among individuals with traumatic brain injury (TBI).~   "
153848|NCT01552564|"~     This study investigates the association between the microvascular resistance at the time of~     primary percutaneous intervention, with microvascular obstruction on CMR and blood markers of~     myocardial damage.~   "
153849|NCT01552551|"~     Older adults at high risk of falls will complete the PA Healthy Steps program. This program~     will be implemented by research staff who will follow the training manual and implement the~     program as it was designed to assess the effectiveness of the program. Participants will then~     be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which~     adherence to physician and home safety assessments will be facilitated; and (iii) Healthy~     Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All~     participants will be followed monthly for 6 months through personal and automated telephone~     interview protocols to ascertain falls and injuries.~   "
153850|NCT01552538|"~     This will be an open label multicenter study of the safety and efficacy of an active~     implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis.~     Patients who complete study SPM-005 will be enrolled in this study at the time of the last~     visit of the preceding study.~   "
153851|NCT01552525|"~     The purpose of the study is to determine the association between acute kidney injury and~     serum levels symmetrical and asymmetrical dimethylarginine (SDMA/ADMA) and their assumptive~     influence on mortality, renal function and on arterial stiffness.~   "
153852|NCT01552512|"~     This randomized, controlled effectiveness study examines Nutributter programming within an~     integrated package of maternal and child health services offered by Haiti's Ministry of~     Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process~     evaluation is to better understand the uptake of Nutributter® as a complementary food in the~     diets of young children and its feasibility and acceptability as part of MSPP's package of~     services. This project is being carried out at a public hospital in Fort San Michel, an~     impoverished community outside of Cap Haitien, Haiti.~   "
153853|NCT01552499|"~     The purpose of this study is to determine whether the EpiFix human amniotic membrane is~     effective in the treatment of diabetic foot ulcers.~   "
153865|NCT01552343|"~     The purpose of this study is to assess psychometric properties (reliability and validity) of~     the Nocturia Impact (NI) diary.~      To assess the association between reduction of number of nocturnal voids and the mean changes~     in NI scores (sensitivity of the NI total score to change in nocturia).~      To assess which NI diary items account for the main difference in change in total NI score in~     treatment versus placebo.~   "
153854|NCT01552486|"~     Comparisons of surgical and non-operative treatment of patients with acute sciatica secondary~     to lumbar intervertebral disc herniation (AS/LDH) have shown no appreciable difference in~     outcome. The composition of the non-operative treatment of this patient population remains~     poorly defined. Spinal manipulative therapy (SMT) has demonstrated value in the treatment of~     AS/LDH. Recent preliminary studies suggest that SMT provides therapeutic benefit through the~     modulation of in vivo inflammatory mediators. This feasibility study will define the key~     experimental variables required to conduct a large multicentre study that will clarify the~     biological and clinical outcomes of SMT in the treatment of patients with AS/LDH.~   "
153855|NCT01552473|"~     This study is being done to improve the ability to diagnose and to achieve higher-levels of~     functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain~     Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12~     months).~   "
153856|NCT01552460|"~     The purpose of this study is to explore the effects of genes and genetic variation on brain~     structure and function. Investigators at Harvard plan to explore the relationship between~     candidate genes that affect cognitive performance and brain structure/function. Since brain~     phenotypes reflect more proximal sequelae of gene activity, neuroimaging measures may show~     greater sensitivity than cognitive performance to measure gene effects.~   "
153857|NCT01552447|"~     The purpose of this study is to determine whether the EpiFix human amniotic membrane is~     effective in the treatment of venous leg ulcers.~   "
153858|NCT01552434|"~     You are being asked to take part in this study because you have an advanced cancer that is~     refractory (has not responded to treatment) or has no standard treatment.~      If you are reading and signing this form on behalf of a potential participant, please note:~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to find the highest tolerable dose of Avastin~     (bevacizumab) and Torisel (temsirolimus) that can be given in combination with either~     valproic acid or cetuximab to patients with advanced cancer that is refractory. The safety of~     this drug combination will also be studied.~      Bevacizumab is designed to block the growth of blood vessels, which may help to slow or block~     the growth of cancer.~      Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to~     die.~      Valproic acid is an anti-seizure drug that may be able to activate tumor-fighting genes,~     causing cancer cells to die.~      Cetuximab is designed to block a certain protein, called EGFR, that is thought to cause~     cancer cells to grow. This may cause cancer cells to die.~      This is an investigational study. Bevacizumab is FDA approved and commercially available for~     the treatment of colorectal cancer and a type of lung cancer. Temsirolimus is FDA approved~     and commercially available for the treatment of kidney cancer that has spread. Cetuximab is~     FDA approved and commercially available for the treatment of colorectal cancer and a type of~     head and neck cancer. Valproic acid is FDA approved and commercially available to help~     control seizures.~      The combination of bevacizumab and temsirolimus is not FDA approved to treat advanced cancer.~     The combination of bevacizumab and temsirolimus with cetuximab or valproic acid is not FDA~     approved to treat advanced cancer. At this time, each study drug combination is being used~     for research only.~      Up to 216 patients will take part in this study. All will be enrolled at MD Anderson.~   "
153859|NCT01552421|"~     Uncomplicated laparoscopic cholecystectomy will in most patients result in moderate to severe~     pain until the first postoperative day. This will subside during the second and third~     postoperative day [1]. A feeling of low general well-being will also be present until the~     first postoperative day and subside during the next couple of days [2].~      To achieve faster recovery after laparoscopic interventions it has been shown that a~     reduction in the size of laparoscopic ports and thereby incisions can reduce postoperative~     pain [3,4].~      A new minimal invasive surgical technique is based on the principle of completely eliminating~     the use of ports through the abdominal wall. This new technique is called Natural Orifice~     Transluminal Endoscopic Surgery (NOTES) and is defined by acquiring minimal invasive access~     to the abdominal cavity through the body's natural openings like the mouth and stomach, anus,~     urethra and vagina. With the NOTES technique one can completely avoid incisions in the~     abdominal wall and thereby reduce the surgical trauma. The benefits of this technique is a~     reduction of postoperative pain, elimination of incisional hernias, prevention of wound~     infections, reduction of peritoneal adherence formation, achieving a faster recovery and a~     better cosmetic result [7,8].~      The most documented and well-described way for gaining NOTES access to the abdominal cavity~     is through the vagina, transvaginal (TV). TV NOTES has mainly been used for cholecystectomy~     because of the direct line of vision to the upper abdomen and gallbladder that is achieved~     through this opening.~      Compilation of results show that TV NOTES cholecystectomy can be implemented with low~     complication rates [20-22]. One retrospective case-control and one prospective observational~     study report less postoperative pain, reduced consumption of analgesics and faster recovery~     for TV NOTES compared to conventional laparoscopic cholecystectomy [23,24]. To date there are~     no systematic prospective randomized data on whether or not TV NOTES cholecystectomy leads to~     a better surgical outcome.~      In the present study the postoperative course after TV NOTES cholecystectomy will be compared~     to laparoscopic cholecystectomy in a prospective randomized and blinded trial. The outcome of~     the randomization between the two surgical techniques will be blinded to patient and the~     nurse staff for the first 72 hours after the operation. The primary outcome parameter will be~     postoperative pain score during the first 24 hours. Secondary outcome parameters are~     postoperative pain score for the first 72 hours, fatigue, well-being, nausea, consumption of~     analgesics, complications, cosmetic result and sexual function.~      The hypothesis being that TV NOTES cholecystectomy gives less postoperative pain, fatigue and~     nausea, a reduction in analgesics and a better cosmetic result and general well-being than~     conventional 4 port laparoscopic cholecystectomy.~   "
153860|NCT01552408|"~     This study is a Phase I/II, multicenter, randomized, study of the efficacy and safety of~     ranibizumab injection monotherapy verses a duel therapy of 0.3mg ranibizumab combined with~     ultra wide, 200° field angiography guided pan retinal photocoagulation in patients with~     CSME-CI secondary to diabetes mellitus (Type 1 or 2).~   "
153861|NCT01552395|"~     A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice~   "
153862|NCT01552382|"~     We will use a retrospective data analysis to evaluate the association of vitamin D status~     with clinical outcome in cardiac surgical patients. The occurrence of several postoperative~     adverse events such as myocardial infarction, low cardiac output syndrome, stroke and~     in-hospital death will be assessed from cardiac surgery to discharge. In addition, we will~     assess the association of vitamin D status with the duration of mechanical ventilatory~     support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital~     stay will be assessed according to vitamin D status.~   "
153863|NCT01552369|"~     This is a trial of preemptive therapy vs. prophylaxis for prevention of Cytomegalovirus (CMV)~     disease in R-D+ liver transplant patients. Subjects will be randomized within 10 days of~     transplant to receive in an open label design, either antiviral prophylaxis with~     valganciclovir, 900 mg orally once daily or preemptive therapy (weekly monitoring for CMV~     viremia by plasma PCR) for 100 days post-randomization with initiation of oral valganciclovir~     900mg orally twice daily at onset of CMV viremia and continued until plasma PCR is negative~     on two consecutive weekly PCR tests). A minimum of 176 subjects will be enrolled in the~     study. The study duration is 7 years. The primary objective of this study is to compare~     prophylaxis versus preemptive therapy using valganciclovir for the prevention of CMV disease~     in R-/D+ liver transplant recipients.~   "
153864|NCT01552356|"~     This phase I trial studies the side effects and the best dose of pazopanib hydrochloride in~     treating patients with solid tumors that has spread to other places in the body and usually~     cannot be cured or controlled with treatment (advanced) or does not respond to treatment~     (refractory). Pazopanib hydrochloride may prevent the growth of new blood vessels that tumors~     need to grow. Studying samples of blood in the laboratory from patients receiving pazopanib~     hydrochloride may help doctors learn more about the effects of the body on the drug. It may~     also help doctors understand how well patients respond to treatment.~   "
153878|NCT01552161|"~     The purpose of this study is to estimate the prevalence of allergic diseases and atopy among~     patients with angiographically confirmed coronary artery disease as well as to assess levels~     of serum allergic inflammation markers in this population.~   "
153866|NCT01552330|"~     The observed changes of P. falciparum sensitivity to artemisinin lead to the intensification~     of early detection as well as treatment monitoring in malaria infection. It is widely~     accepted that the development of resistance can be delayed by the use of combination therapy,~     especially combinations that include artemisinin derivatives (acts). As the resistance~     problem is considered extremely serious; as a consequence, who has recommended that all~     monotherapy for malaria should be stopped.~      Current WHO guidelines recommend that the drug combination regimens using ACT with effective~     partner medicines should be used to decrease the risk of development or spreading of~     artemisinin resistance.~   "
153867|NCT01552317|"~     Patients with kidney disease benefit from reducing the amount of salt in the food that they~     eat. The benefits include lower blood pressure and better kidney function. Therefore,~     lowering the amount of salt that is eaten could reduce the number of people who will develop~     kidney failure. The effect on blood pressure could also reduce the number of strokes and~     heart attacks. Similar benefits are also seen for people without kidney disease.~      Guidelines for patients with kidney disease recommend that they lower the amount of salt that~     they eat, but most patients do not manage to do this. The reasons for this are not unclear,~     but are likely to reflect the difficulty that patients have in reducing the amount of salt in~     their food and the nature of the advice that they are given.~      The investigators have developed a package of interventions to help patients to make~     healthier choices that will lower their salt intake. The package helps patients to learn~     about salt in food and how to avoid it. It provide practical advice on cutting down on salt~     using information booklets, text messages, emails, telephone calls, and a website.~      Participants will be recruited from hospital kidney clinics and general practice. The~     investigators will randomly allocate participants to receive either the normal care that they~     would get or to receive the new package of interventions to help them lower salt. The package~     of interventions will involve patients receiving text messages, telephone calls, emails and~     written information. They will complete a questionnaire and collect urine samples which will~     can be used to measure the amount of salt that they are eating. No more than 6 visits will be~     required. The study is funded by the British Renal Society which is a charity that funds~     research to help patients with kidney disease.~   "
153868|NCT01552304|"~     Hypotheses:~        1. Postoperative oxygen therapy significantly improves postoperative oxygenation in OSA~          surgical patients.~        2. Postoperative oxygen therapy do not significantly increase the number of apnea episodes~          and the duration of apnea episodes.~        3. Postoperative oxygen therapy do not significantly increase arterial carbon dioxide(CO2)~          level in OSA surgical patients.~   "
153869|NCT01552291|"~     Malnutrition occurs in up to 50% of patients requiring elective surgery for neoplastic~     diseases. It exerts a detrimental influence on outcome of surgery, because it can suppress~     immune function, exaggerate stress response and cause organ system dysfunction. Increased~     susceptibility to infection, protracted wound healing, impaired blood clotting and vessel~     wall fragility have been shown to be the leading causes of postoperative morbidity and~     mortality in malnourished patients undergoing major surgical resections.~      This trial is designed as a prospective randomized, double-blinded, placebo-controlled pilot~     study in a academic single center in Switzerland. A total of 50 malnourished patients with~     gastro-intestinal tumors will receive orally glutamine or placebo-treatment during a period~     of 5 days prior to surgery. The investigators hypothesize that oral Glutamine administration~     is feasible, well tolerated, will decrease postoperative morbidity, will suppress~     postoperative cell damage and inflammatory response, and will improve the perioperative~     immunocompetence of the patients.~   "
153870|NCT01552265|"~     This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who~     convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the~     conversion.~   "
153871|NCT01552252|"~     The null hypothesis tested was that there are no differences in the taste palatability of the~     apple juices before and after adding POs-Ca.~   "
153872|NCT01552239|"~     RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to~     minimize morbidity and maximize efficacy. An additional boost dose can be provided locally by~     HDR-brachytherapy in patients with positive margins after tumor resection.~      PURPOSE: This phase II trial is studying the safety and efficacy of a combination of modern~     radiotherapy elements applied to the tumor and small volumes of surrounding normal tissue~     (IMRT, IGRT; brachytherapy in case of positive resection margin) and see how well it works in~     treating patients with High-Risk Soft Tissue Sarcoma of the Extremities.~   "
153873|NCT01552226|"~     This is a prospective randomized study of 114 patients. The purpose of this study is to~     compare the efficacy of two standard methods of analgesia for pain control in patients~     undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and~     by the need for supplemental narcotic analgesics. This study is designed to determine if~     postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q~     Silver SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA).~   "
153874|NCT01552213|"~     The investigators hope to learn whether treatment with medical nutrition therapy (MNT) for~     pregnant women with prediabetes decreases the rate and severity of impaired glucose tolerance~     later in pregnancy and improves perinatal outcomes. Given the rising rates of obesity and~     diabetes in this country even among young women and the adverse affects of diabetes of~     pregnant women and their infants, the investigators feel that it is important to not only~     identify women at high risk for diabetes early in pregnancy but determine the appropriate~     management strategy~   "
153875|NCT01552200|"~     The purpose of this study is to compare the additional diagnostic yield obtained by~     performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard~     colonoscopy procedure.~   "
153876|NCT01552187|"~     This is a multicenter, double-blind, randomized trial to assess the efficacy and safety of~     colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention,~     and post-operative atrial fibrillation prevention.~   "
153877|NCT01552174|"~     The purpose of this study is to determine the incidence and characteristics of eyelid~     inflammatory disorders during general ophthalmological consultations and to demonstrate~     association between palpebral pathologies and ocular surface pathologies.~   "
162157|NCT01443364|"~     The study aims to evaluate the predictability of early response to Certolizumab pegol in~     combination with Methotrexate at one year in patients with moderate to severe rheumatoid~     arthritis.~   "
153879|NCT01552148|"~     Purpose To evaluate whether adding a transversus abdominis plane block in patients undergoing~     elective laparoscopic hysterectomy reduces Patient-controlled analgesia (PCA) morphine~     requirements during the first 24 hours postoperatively.~      Forty-six patients undergoing laparoscopic hysterectomy will be randomized into two groups:~        1. Group treatment TAP (n=23) will receive the following analgesia:~             -  US guided transversus abdominis plane block performed with 40ml of 0.375%~               levobupivacaine (20 ml per side) after general anaesthesia induction, before~               surgical start~             -  Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at~               rest~        2. Group control will receive:~             -  Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at~               rest~      Primary Outcome Measures:~      Morphine consumption (mg) (Time Frame: 24 hours) in Groups TAP and Control~      Secondary Outcome Measures:~        -  Pain at rest and during movement quantified as Numerical Rating Scores (0-10) for pain~          when resting in bed and during cough during the first 24 hours postoperatively~        -  Time to PACU dimission, evaluated as patient's achievement of a White's score > or =~          12/14~        -  Time to home discharge, evaluated as patient's achievement of a PADDS score > or = 9~        -  Functional patient capacity as measured before surgery and whenever a White's score > or~          = 12 will be reached (2minute walking test)~        -  Eventual side effects such as nausea/vomiting~   "
153880|NCT01552135|"~     The investigators want to study if nanoparticles of titaniumdioxide are penetrating skin when~     the skin is intact and when the skin is sunburned. The hypothesis is Does nanotitandioxide~     penetrate intact or sunburned skin?~   "
153881|NCT01552122|"~     This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral~     density in osteoporotic postmenopausal women who were previously treated with alendronate.~   "
153882|NCT01552109|"~     The purpose of this study is to describe the clinical profile and current status of the~     diagnosis and management of stable angina in India by non-interventional consulting~     physicians (CP) through a large multicenter observational registry.~   "
153883|NCT01552096|"~     The investigators postulate that the use of pre-incisional peritonsillar infiltration of~     tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic~     consumption, without harmful effects. Therefore, the present study is designed to evaluate~     the effects of infiltration of tramadol or lidocaine on the postoperative acute-phase serum~     protein, C-reactive protein, and analgesic consumption after tonsillectomy.~   "
153884|NCT01552083|"~     The purpose of this study is to evaluate the feasibility and the effectiveness of sleep apnea~     screening program for patients at risk in community pharmacies.~   "
153885|NCT01552070|"~     The purpose of this study is to investigate the change of extravascular lung water (EVLW),~     cytokine and oxygenation parameters in patients with acute lung injury (ALI) or acute~     respiratory distress syndrome (ARDS) after alveolar recruitment maneuver.~   "
153886|NCT01552057|"~     The purpose of the study is to assess the effectiveness and safety of duloxetine in~     participants with fibromyalgia.~   "
153887|NCT01552044|"~     The objective of the study is to evaluate the effect of spironolactone on 16 patients~     presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate~     whether spironolactone can resolve sub retinal fluid in these patients.~      CSCR is a major cause of visual loss in the young population. It is characterized by sub~     retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes~     of the disease remain unknown but a choroidopathy has been suggested. Moreover,~     corticotherapy and stress are known risk factors of CSCR.~      Our preclinical studies have demonstrated that the mineralocorticoid pathway could be~     involved in the control of choroidal blood flow.~      The investigators propose to evaluate the mineralocorticoid receptors antagonist~     spironolactone in the treatment of CSCR.~      Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary endpoint:~     visual acuity gain ≥ 15 EDTRS letters~   "
153888|NCT01552031|"~     Chronic obstructive pulmonary disease (COPD) is a pathological condition whose progression is~     characterized by stable periods broken up by intermittent acute exacerbations of the~     symptoms, during which a severe inflammatory process occurs often requiring hospitalization.~     During exacerbations the risk of death is very high making the social and economical impact~     of such events important.~      The need of rationalize the utilization of health care resources together with the~     optimization of patient's care has prompted the development of models of assistance based on~     home monitoring. At the present time most of the suggested models were based on the~     utilization of diaries for symptoms perceived by the patients. Even if positive results are~     reported in terms of reduction of in hospitalization many COPD patients tend to underestimate~     the severity of their condition and their compliance in recording their symptoms rapidly~     decreases with time.~      Attempts of using more objective measurements such as home spirometers have been done but~     poor results were reported mainly due to the difficulties in performing a spirometric test~     without medical supervision.~      A more suitable approach to get objective information on the function of the respiratory~     system is the Forced Oscillation Technique (FOT). Such methodology is based on the analysis~     of the response of the system to small pressure stimuli over-imposed to the normal breathing~     of the patients. The measurements require minimal cooperation and can be performed without~     medical supervision.~      The purpose of this study is to measure daily variability of FOT data measured at home of a~     group of COPD patients in order to identify possible correlations between symptoms change,~     breathing pattern, lung mechanical impedance and occurrence of exacerbation.~   "
153909|NCT01551758|"~     This study is designed to compare the effectiveness and safety of Fluticasone~     Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg~     Vilanterol ((VI), GW642444)) delivered once daily via a Novel Dry Powder Inhaler (NDPI)~     compared with the existing COPD maintenance therapy over twelve months in subjects diagnosed~     with COPD. This is a Phase III multi-centre, randomised open label study. Subjects who meet~     the eligibility criteria are randomised and will enter a 12 month treatment period.~   "
153910|NCT01551745|"~     This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab.~     All patients will have had Vigil™ prepared and stored from initial primary surgical~     debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7~     cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2~     weeks.~   "
153889|NCT01552018|"~     Dipeptidyl peptidase 4 (DPP-4) inhibitors are approved as add on therapy to improve glycaemic~     control in Type 2 Diabetes Mellitus (T2DM). DPP-4 inactivates the incretin hormone~     glucagon-like peptide 1 (GLP-1). Inhibiting the inactivation of GLP-1 leads to increased~     insulin- and reduced glucagon secretion after meals. DPP-4 has been shown to be present in~     atherosclerotic plaques. DPP-4 is a protease with substrates including cytokines and~     chemokines associated with atherosclerosis/inflammation.~      The purpose of this study is to explore the effects of 3 months intervention with DPP-4~     inhibitor saxagliptin on biomarkers related to atherosclerosis in patients with stable~     coronary artery disease (CAD) and T2DM, on circulating levels and on expression levels in~     circulating monocytes and adipose tissue.~      A reduction in markers associated with atherosclerosis could indicate an antiatherosclerotic~     effect of DPP-4 inhibitors beyond glycaemic control alone.~      Due to reduced sample size (recruitment problems) the main focus has changed and will now be~     on cellular aspects and gene regulation (initially secondary outcome measure).~   "
153890|NCT01552005|"~     The purpose of this study is to respond to The French Health Authority which has requested~     BMS France and Astra Zeneca (AZ) France to set-up a long-term cohort study in a~     representative sample of French Type 2 Diabetes mellitus (T2D) patients treated with~     Saxagliptin to generate real world data on drug utilization, joint population, non~     comparative effectiveness and safety~   "
153891|NCT01551992|"~     1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh~     attachment during laparoscopic sacrocolpopexy (LSC): running technique using self-anchoring 1~     barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver,~     Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™,~     Ethicon, Somerville, NJ, USA).~      1.2 SECONDARY OBJECTIVE - To compare laparoscopic sacrocolpopexy anatomic failure rates at 6~     months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture~     (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed~     absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess~     mesh erosion rates, costs, and surgeon satisfaction rates.~      2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with~     self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals,~     Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using~     0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1~     barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver,~     Canada) will be less costly than the standard fixation interrupted technique using 0~     non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.~      2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based~     on subjective surgeon satisfaction questionnaires.~   "
153892|NCT01551979|"~     The aim of this study is to look at the effectiveness of repetitive transcranial magnetic~     stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia. The primary~     outcome is improvement in negative symptoms related to schizophrenia. The investigators are~     focusing on negative symptoms given their greater resistance to pharmacological and other~     established therapies. If the investigators trial were to show beneficial effects, its~     clinical significance would be great.~   "
153893|NCT01551966|"~     The portal hypertension (PHT) is the main complication in patients presenting with cirrhosis.~     It can be the direct cause of bleeding by rupture of the esophageal or gastric varices and~     can also contribute to the development of ascites, hepatic encephalopathy and pleuropulmonary~     complications.~      In the paediatric population presenting with the PHT, one of every two children develops~     varices and thus has a significant risk of bleeding. Safe and easy to use, the video capsule~     endoscopy (VCE) is now routinely used in children for the exploration of the small bowel. But~     the role of the VCE for examination of the other parts of digestive tract still needs to be~     evaluated.~      For the esophagus, the VCE could allow the diagnosis without the need of general sedation.~     Recent studies have shown a good sensitivity and tolerance of this technique for the initial~     diagnosis of esophageal varices (EV) in adult patients presenting with portal hypertension,~     but it has not yet been validated for this indication.~      The investigators hypothesize that the VCE could be used in children with similar results in~     term of efficacy, as for adults.~      This prospective simple blind multicentre study (blind for the lecture of the capsule~     endoscopy record), will investigate the diagnostic value of the VCE compared to the~     conventional esophagogastroduodenoscopy (EGD) under general sedation for the detection and~     the control of esophageal varices in children.~      If it is provided that the VCE is as efficient as it is for the adults, it could become a~     very interesting alternative to the conventional EGD because less expensive and less~     invasive. Moreover, this technique would be very useful as a means of early detection on the~     EV and/or their control.~   "
153894|NCT01551953|"~     The main purpose of this study is to determine feasibility and effects of tai chi and~     mind-body breathing in patients with COPD.~   "
153895|NCT01551940|"~     Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral~     sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in~     parotids and submandibular glands. The investigators want to demonstrate 1 month after the~     injection, by a multicenter French randomized double blind study, an improvement of at least~     25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a~     decrease of the quantity of saliva and a decrease of the embarrassment for the main~     caregiver.~   "
153911|NCT01551732|"~     The purpose of this study is to determine whether adding an interactive biofeedback video~     game to anger control cognitive behavioral therapy is an effective and feasible treatment.~   "
153912|NCT01551719|"~     The general objective of the study is to assess whether the implementation of the antibiotic~     essay with the Breakpoint/MIC ratio and data on penetration of the antibiotic in the site of~     infection may improve the outcome of infections compared to using only the standard~     procedures.~   "
153913|NCT01551706|"~     This is a Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of~     ENI Patented Whole Grape Extract on Antioxidant Status.~   "
164142|NCT01417312|"~     This study aims to investigate metabolic effects of a standardized green tea extract,~     containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis~     patients.~   "
153896|NCT01551927|"~     Aim: To investigate and compare women's and men's expectations before investigation and~     treatment of suspected coronary artery disease and to examine how these expectations are met.~      Do women and men, of different ages, have the same expectations for the evaluation and~     treatment of stable coronary artery disease and are their expectations met in a equal degree?~      Are there differences in expectations and the fulfilment of these according to age and other~     clinical history variables? Do the findings in the specially developed questionnaire designed~     to gather patients' expectations to the outcome on quality of life and degree of angina~     pectoris relate to their appearance in the designated forms? Is there a relationship between~     NTproBNP - levels, as a measure of cardiac workload, and expectations and the fulfilment of~     these as well as the quality of life and degree of angina pectoris?~      Method: Patients will be asked to participate in the study, in the context of medical~     consultation before coronary angiography by a physician and / or a study nurse. This occurs~     during an outpatient visit at the cardiac clinic at the respective centre. Included are all~     patients planned for elective coronary angiography before possible revascularization during a~     eight month period regardless of diagnosis. Including are four hospitals in the region of~     Västra Götaland.~   "
153897|NCT01551914|"~     The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon~     Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy)~     by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to~     conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary~     objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii)~     postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques~     (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs~     and medical outcomes and (vii) an estimation of the potential impact of new technology on the~     organization of operating rooms (operating time).~   "
153898|NCT01551901|"~     The purpose of this trial is to evaluate the performance, safety and effectiveness of the~     Luna system for the treatment of degenerative disc disease.~   "
153899|NCT01551888|"~     The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and~     tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall~     Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for~     five days to patients with moderate to severe COPD.~   "
153900|NCT01551875|"~     This non-interventional, prospective, multi-centric, cross-sectional study is aimed to obtain~     the distribution of measurements of CIMT in Indian subjects and will involve approx. 30~     investigative sites from all over the country. Each investigative site will be expected to~     enrol 50 subjects and Carotid intima-media thickness (CIMT) values will be taken for each~     individual as described in the protocol.~      All the procedures could be completed in a single day, however due to any reason any study~     variable is not taken subject may be asked to come back for a second visit within 7 days of~     the first visit.~   "
153901|NCT01551862|"~     A prospective study on 50 consecutive patients who are going to have a lower body lift~     procedure is performed. Measures include comorbidities and complications. Risk factors~     assessed including patient age, gender, highest lifetime body mass index (BMI) (BMI max),~     current BMI, excess weight loss (EWL), type of weight loss and nicotine consumption.~   "
153902|NCT01551849|"~     The purpose of this study is to evaluate echocardiographic markers of cardiac function to~     assess the ability of patients to successfully end VA-ECMO support.~   "
153903|NCT01551836|"~     This will be a single centre, open label, randomised, two-way crossover study in healthy~     volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in~     this study to establish at what time point a therapeutic concentration of paracetamol in the~     blood is reached. Subjects will attend a screening visit to check if they are eligible for~     study participation then within 15 days they will check-in to the unit for a stay of~     approximately 48 hours (hrs). They will be given a single dose of one of the preparations on~     the first day and then the other preparation on the next day. Regular blood samples will be~     taken along with other assessments for safety.~   "
153904|NCT01551823|"~     The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus~     Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains~     Preservative.~   "
153905|NCT01551810|"~     The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus~     Vaccine (Split Virion, Inactivated) that do not contains Preservative .~   "
153906|NCT01551797|"~     This proof of principle study will evaluate an experimental formulation of paracetamol that~     is being developed for eventual long lasting use. This study is also used for drug safety~     evaluation.~   "
153907|NCT01551784|"~     The aim with this study is to investigate the effect of statin induced changes in HDL-C on~     all cause mortality and CVD with adjustment for changes in other blood lipids and clinical~     parameters in Sweden, UK and the Netherlands.~   "
153908|NCT01551771|"~     This study is the first administration of GW824575 in humans. This will be a single centre,~     masked, placebo-controlled study, to investigate the safety, tolerability, pharmacokinetics~     (PK) and pharmacodynamics (PD) of GW824575, given as single and repeated oral doses to~     healthy male subjects. The study will be comprised of 4 parts and enroll approximately 40~     subjects: Part A will consist of two cohorts of 8 healthy male subjects to assess the safety,~     tolerability, PK, and PD of ascending single oral doses of GW824575. All available safety,~     tolerability, and PK data will be monitored prior to each dose escalation. In order to~     support the possible indication for age-related macular degeneration (AMD), Part B will be~     one cohort of 12 subjects to examine the safety, tolerability, PK, and PD of a repeated dose~     of GW824575 over 21 days in healthy male subjects who are greater than or equal to 50 years~     of age. The total daily dose in this cohort will not exceed the maximum tolerated dose (MTD)~     from Parts A and D. Subjects in this cohort will undergo ophthalmology assessments before~     receiving investigational product and after Day 7 of the 21-day in-patient treatment, after~     steady state has been reached. As part of protocol amendment 2, Part C (Cohort 4) is removed~     from the protocol. Part D, added under protocol amendment 2, will consist of one cohort of 12~     healthy male subjects to assess safety, tolerability, PK, and PD of ascending single doses of~     GW824575 as well as the effect of food on the PK of GW824575.~   "
153931|NCT01551472|"~     The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using~     Vitamin E UHMWPE tibial inserts for total knee replacement surgery.~   "
153914|NCT01551693|"~     STA9090 is a drug which inactivates or blocks the work of a protein called Heat Shock Protein~     90 or HSP90. HSP90 is a protein that helps some molecules inside your cells to have the right~     shape. By stopping HSP90's activity, those molecules never get to have the right structure of~     be functional and they are destroyed. The investigators believe that if they stop the~     activity of HSP90, the rapidly dividing cells that are in your tumor(s) may slow down. In~     this research study the investigators are looking to see how well STA9090 works in stopping~     the spread of your melanoma.~   "
153915|NCT01551680|"~     Recent pre-clinical and clinical data have indicated that BSI-201 does not possess~     characteristics typical of the PARP inhibitor class. Based on the results from in vitro and~     in vivo studies, this trial aims to evaluate the combination of BSI-201 concomitantly with~     radiotherapy in patients who present with multiple non operable brain metastases. As~     radiotherapy is a local treatment targeting only the tumor, and because the molecule BSI-201~     has shown no major toxicity against tissues without DNA alterations, the proposed combination~     is expected to provide tumor-selective therapy and leading to a clinical benefit improvement.~      Primary objective is to determine the recommended phase II dose (RP2D) and evaluate acute~     toxicity (CTC-AE v4.0 grading scale) of concurrent administration of whole brain radiotherapy~     (WBR) and a small molecule BSI-201 in non operable brain metastases.~   "
153916|NCT01551667|"~     The primary objective of this study is to detect differences in anti-S. aureus antibody~     assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia due~     to a chronic wound (cases) and (2) a group of patients with localized chronic wound~     infections (control).~   "
153917|NCT01551654|"~     Colonoscopy is a stressful and unpleasant procedure especially during the passage of the~     endoscope through angulations of colon. Electro-acupuncture is one of the alternative to~     reduce colorectal discomfort. However acupuncture is invasive. This present study explored~     the effectiveness of a non-invasive treatment modality, Transcutaneous Electrical Nerve~     Stimulation over Acupuncture points in reduction of colorectal discomfort during~     barostat-induced rectal distension.~   "
153918|NCT01551641|"~     The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients~     by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer~     receiving chemoradiotherapy were divided into different sub-group according to dynamic change~     of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at~     random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were~     evaluated, and at the same time, activity of thalidomide on esophageal cancer and its~     clinical safely were assessed.~   "
153919|NCT01551628|"~     The purpose of this study is to determine whether Recombinant Human Arginase 1 (rhArg1)is~     safe and effective in the treatment of patients with Relapsed or Refractory Leukemia or~     Lymphoma.~   "
153920|NCT01551615|"~     Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone~     and In Combination with Vandetanib~   "
153921|NCT01551602|"~     The objective of this study is to investigate the pharmacokinetics, safety, and tolerability~     of AK159 administered to healthy postmenopausal women.~   "
153922|NCT01551589|"~     This study examines contrast advantages and disadvantages of elective or prophylactic nodal~     irradiation in the treatment of esophageal cancer with three-dimensional conformed~     radiotherapy.~   "
153923|NCT01551576|"~     The purpose of our study is to image human prostate tissue using a transrectal photoacoustic~     imaging probe.~   "
153924|NCT01551563|"~     The study aims at studying the outcomes of a protocol-based handling of newly diagnosed~     Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a~     descriptive study and no hypothesis is predefined.~      Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating~     purposes.~   "
153925|NCT01551550|"~     This is a multi-site randomized clinical trial to evaluate the long-term efficacy of the~     thicker amniotic membrane graft (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) in reducing shunt~     tube exposure in patients undergoing glaucoma drainage device implantation.~   "
153926|NCT01551537|"~     This PMS study aims to collect safety and reactogenicity data of Cervarix in the local~     population as per the licensing requirement of the Sri Lankan regulatory authority.~   "
153927|NCT01551524|"~     This study is an open label, multicenter study with a dose escalation of Asparec®~     administered once every two to four weeks for two administrations. The primary objective of~     this study is to determine the Maximum Tolerated Dose following one single dose of Asparec~     when administered in a population of patients with relapsed or refractory hematological~     malignancies, as measured by Dose Limiting toxicities. There are secondary objectives which~     are to evaluate the safety of Asparec and to determine the PK profile as assessed by~     measurement of plasma L-asparaginase enzymatic activity following single and repeated doses~     of Asparec. Patients response rate will be evaluated and Anti-Asparec antibodies will be~     measured.~   "
153928|NCT01551511|"~     Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and~     long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as~     first choice in pain management of CP, resulting in regularly prescription of opioids. The~     adverse consequences of prolonged opioid use, including addiction, tolerance and opioid~     induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to~     treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive~     substance of the cannabis plant, has been shown in previous studies to be a promising~     analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an~     improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of~     Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy~     of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain~     resulting from CP.~   "
153929|NCT01551498|"~     This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc~     dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid~     function in subjects with autoimmune thyroiditis.~   "
153930|NCT01551485|"~     Sleep after surgery has been found to be very distrubed immediately after major surgery. This~     is also seen after fast-track hip and knee replacement with length of stay of less than 3~     days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and~     decline in cognitive abilities.~   "
153932|NCT01551459|"~     Doctors usually treat uveal melanoma with radiotherapy or surgery. But if this cancer~     spreads, it is more difficult to treat.~      Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine,~     but they are always looking to find new ways to treat uveal melanoma.~      This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how~     long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse.~   "
153933|NCT01551446|"~     This study is to evaluate the variability of several pharmacodynamic measures of kidney~     function, cardiovascular function, cerebral perfusion, and haemodynamics.~   "
153934|NCT01551433|"~     The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal~     of a portion of the stomach and esophagus with re-attachment) there is an association between~     the intraoperative level of oxygen at the site where the esophagus is re-attached to the~     stomach (measured using the Wipox), and the incidence of a disruption at the site of the~     attachment after the surgery.~   "
153935|NCT01551420|"~     The overall study objective is to examine the feasibility, acceptance, and benefits of home~     use of an advanced upper limb prosthetic device as well as the logistical support~     requirements utilized during 3 months of home usage. All participating subjects will enroll~     in Part A of the study which will involve supervised training. Eligible subjects will be~     invited to participate in Part B, the home use portion of the study.~   "
153936|NCT01551407|"~     The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible~     cystoscopy in the detection of histological confirmed bladder tumor lesions defined as~     dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.~   "
153937|NCT01551394|"~     This phase III multicentric international randomized trial is designed to compare the~     efficacy of Meropenem to the standard of care in infants below 90 days of age with clinical~     or confirmed late-onset sepsis (LOS).~      The aim is to assess efficacy , pharmacokinetics and safety of Meropenem which are not well~     known and documented in this population.~   "
153938|NCT01551381|"~     The principal objective of this study is to evaluate the safety and tolerability of repeated~     doses of EV-077-3201-2TBS given to diabetic subjects over a 4 week treatment period. The~     secondary aim of this initial Phase IIa study is to evaluate the effect of multiple oral~     doses of EV-077-3201-2TBS on platelet function, vascular function, vascular inflammation,~     vascular oxidative stress, renal function and a selection of exploratory parameters and~     biomarkers in type 2 diabetic subjects, as well as multiple dose pharmacokinetics in diabetic~     subjects.~      In order to ensure the safety of the diabetic subjects, initial parts of the study will~     evaluate the safety and tolerability of EV-077-3201-2TBS. In Part A, the safety of different~     doses EV-077-3201-2TBS will be investigated in healthy subjects treated for 4 weeks. In~     parallel, Part B will investigate potential interactions between EV-077-3201-2TBS and ASA in~     healthy subjects. Part C will then investigate the safety, pharmacokinetics and~     pharmacodynamics of EV-077-3201-2TBS in type 2 diabetic subjects with and without concomitant~     ASA therapy.~   "
153939|NCT01551368|"~     Nimodipine (Nimotop® Bayer Pharmaceuticals Corporation), unlike other calcium channel~     blockers is fat soluble and therefore is able to cross the blood-brain barrier1. Gonadotropin~     releasing hormone (GnRH) neurons are clustered in the hypothalamus and are dependent on~     calcium flux to release GnRH responsible for the release of follicle-stimulating hormone~     (FSH) and luteinizing hormone (LH) from the anterior pituitary. In a natural menstrual cycle~     a spontaneous LH surge occurs mid-cycle which triggers ovulation. The investigators~     hypothesized that nimodipine, by blocking calcium channels, may effectively suppress the~     release of GnRH and consequently the natural LH surge.~      In this prospective double-blinded randomized study the investigators will evaluate the~     efficacy of nimodipine to inhibit the natural LH surge in women undergoing controlled ovarian~     stimulation (COS) and intrauterine insemination (IUI). Nimodipine, if successful, may~     represent an inexpensive oral medication as an alternative to the currently used GnRH~     agonists or GnRH antagonists in assisted reproductive technologies like IVF.~   "
153940|NCT01551355|"~     As part of the Colombian Hearty Health Initiative program led by Mount Sinai Cardiovascular~     Institute, a multidisciplinary team design and implemented a pedagogic and communication~     strategies for the promotion of healthy heart habits (PPHH) in preschoolers. This included~     educational materials, pedagogical activities and the use of Sesame Workshop healthy habits~     for life materials. For Colombia, the latter were largely developed in collaboration with the~     Colombian Society of Pediatrics, Colombian Society of Cardiology and Cardiovascular Surgery,~     Colsubsidio and Fundación Cardioinfantil-Instituto de Cardiología.~   "
153941|NCT01551342|"~     -  This study includes two semi-consecutive parts:~             -  Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect®~               device for identifying bladder cancer cells in urine samples.~             -  Part II Prospective, controlled, blinded part to determine the performance of the~               CellDetect® device in monitoring bladder cancer recurrence in patients with a~               history of TCC, using urine cytology samples~        -  The following subjects will be enrolled:~      Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic~     surveillance, TURT or Cystectomy.~   "
153942|NCT01551329|"~     The purpose of this study is to evaluate the efficacy of ketamine in reducing depressive~     symptoms in subjects with a comorbid major depressive episode and alcohol dependence. The~     investigators hypothesize the following for the present study:~      A single dose of ketamine will induce a rapid, robust and sustained reduction in depressive~     symptoms in subjects with a comorbid major depressive episode and alcohol dependence relative~     to placebo as defined by change in Hamilton Depression Rating Scale total scores at 72 hours~     post infusion.~      A single dose of ketamine can be delivered safely, with minimal adverse events or~     complications, in subjects with a comorbid major depressive episode and alcohol dependence.~   "
153958|NCT01551121|"~     3 Nursing homes in the Limousin region will be equipped with the automated telesurveillance~     system. Patient will be selected by general practitioner and randomized into two groups after~     informed consent. One group will have cameras installed and the other will not and will act~     as a comparison group. Patient will be assessed three times during the study, at inclusion, 6~     months and 12 months. Each assessment is composed of a standard geriatric assessment, a fall~     questionnaire, an autonomy scale (SMAF scale) and a quality of life questionnaire (EQ5D).~     Every falls will be considered as adverse events and will therefore be listed along the study~     and characterized in types and number.~   "
153943|NCT01551316|"~     In MediciNova's clinical development plan for MN-221, it was recognized that treatment of~     COPD exacerbations may necessitate more than one single i.v. infusion and that patients in~     this population may have more co-morbidities (and concomitant medications) than has been~     generally studied so far. Thus, the primary objective of this clinical study is to determine~     the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to~     placebo with repeated administration over several days in moderate to severe COPD patients~     who may also have co-morbidities and concomitant medications (CM) common in this population.~     Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1).~      This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year~     (MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human~     clinical trial information.~   "
153944|NCT01551303|"~     The purpose of this study is to learn more about how emotional processing may be affected by~     a hormone called oxytocin. Oxytocin is a hormone that occurs naturally in the body, and may~     play an important role in the way that the brain perceives information.~   "
153945|NCT01551290|"~     The purpose of this study is to evaluate the effectiveness and safety of infliximab in~     Chinese patients with active ulcerative colitis (swelling and ulceration of large intestine~     and rectum).~   "
153946|NCT01551277|"~     Objectives: To evaluate the effects of the technique of Breath Stacking (BS) in the~     distribution of ventilation in the chest in women with morbid obesity. Methods: Randomized~     clinical trial, blinded, and controlled with 32 women (BMI ≥ 40kg/m2), separated into two~     groups: control (GC) with n = 16 and 41.94 ± 9.38 years and group Breath Stacking (GBS) , n =~     16 and 40.38 ± 10.16 years. Optoelectronic plethysmography (POE) was used to assess lung~     ventilation. For the BS technique was used to mask the expiratory branch occluded and Wright~     spirometer. GBS held three techniques with an interval of three minutes. The GC used the same~     circuit without the occlusion of the expiratory branch. Results: GBS was found to be higher~     in the contribution of tidal volume (VT) into the chest circumference (p = 0.04) and decrease~     in abdominal compartment (p = 0.03), whereas the CG showed no difference in distribution.~     Spirometric variables: FEV1 (%), FVC (%), FEV1/FVC (%), VC and CI showed no difference before~     and after the technical BS and GBS in the GC. Conclusions: The technique BS altered the~     distribution pattern of regional ventilation, resulting in greater contribution in lung~     volume in the lower rib cage, corresponding to activity of the diaphragm, with redistribution~     of volume between compartments.~   "
153947|NCT01551264|"~     Prolonged bracing reduces the rate of clubfoot recurrence. In addition to bracing length,~     other factors, including compliance with bracing, gender, age, severity of clubfoot deformity~     and family history contribute to clubfoot recurrence.~   "
153948|NCT01551251|"~     The purpose of this study is to investigate the effects of tumor associated macrophage (TAM)~     in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and outcome~     of these subjects. Pathologic specimens from tissue bank will be stained by immunostaining~     methods with CD68 antibody. The clinical treatment response and outcomes will be analyzed~     between high or low TAM.~   "
153949|NCT01551238|"~     The purpose of this study is to determine energy expenditure and sleep in response to~     protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of~     time.~   "
153950|NCT01551225|"~     This study will be executed according to a randomized double-blind placebo-controlled trial~     with two parallel groups, treated over the period of 6 months with escitalopram or placebo.~      Hypotheses: Escitalopram is more effective than placebo in the control of gastrointestinal~     symptoms, in irritable bowel syndrome (IBS) patients with panic disorder. Escitalopram is~     more effective than placebo in the control of psychiatric symptoms, in IBS patients with~     panic disorder.~   "
153951|NCT01551212|"~     This trial will evaluate the efficacy of Everolimus in combination tacrolimus versus a~     standard immunosuppressive regimen concerning kidney function in liver transplant recipients.~   "
153952|NCT01551199|"~     To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure~     Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid~     posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase~     of the study will examine the feasibility and acceptability of MCET-V.~   "
153953|NCT01551186|"~     The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus~     GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in~     patients on a ventilator.~   "
153954|NCT01551173|"~     This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release~     Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C~     lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or~     mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when~     treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.~   "
153955|NCT01551160|"~     Patients in hospital can have unexpected clinical emergencies. When this occurs the Medical~     Emergency Team (MET) are called with the intention of resolving the problem. Previous~     investigations have found that patients who have more than one call during their admission~     have worse outcomes than patients who only have one call. But it has not been established~     why.~      The aim of this research will be to examine these repeated calls and why patients subject to~     them go on to have worse outcomes. A predictive model will be developed to identify potential~     sources of risk. One potential source is poor communication between health care providers. An~     intervention to improve communication around MET calls may provide benefit to patients and~     improve outcomes.~   "
153956|NCT01551147|"~     The primary objectives are~        -  to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on~          early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled~          allergen~        -  to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days~          in patients with asthma~      The secondary objectives are:~        -  to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1 following~          allergen exposure, and~        -  to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced~          airway hyperresponsiveness (AHR) as measured by methacholine challenge~   "
153957|NCT01551134|"~     The aim of the study was to compare short- and longterm outcomes after laparoscopic and open~     Nissen fundoplication in children.~   "
153962|NCT01551069|"~     Primary Objective:~      - To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily~     regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus~     (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI [Cutaneous~     Lupus Erythematosus Disease Area and Severity Index] activity score is ≥4) concomitant~     treatment with or without corticosteroid.~      Secondary Objectives:~        -  To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of~          once daily regiment of HCQ versus placebo as the reference group in patients with CLE~          and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant~          treatment with or without corticosteroid.~        -  To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in~          patients with CLE and SLE with active skin manifestation concomitant treatment with or~          without corticosteroid.~        -  To investigate the safety and efficacy of 52 weeks long-term treatment of once daily~          regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose~          reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with~          corticosteroid~        -  To investigate efficacy of once daily regimen of HCQ on systemic symptoms,~          musculoskeletal symptoms and immunological parameters in SLE patients.~   "
153963|NCT01551056|"~     The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%~     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in~     the conjunctival allergen challenge (CAC) model.~   "
153964|NCT01551043|"~     The primary objective is to determine the safety and survival of the redirected allogeneic T~     cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).~   "
153965|NCT01551030|"~     The purpose of this study is to learn what effects, good and/or bad, Buparlisib has on~     advanced urothelial cancer. Buparlisib is a pill that works by shutting down some of the~     signals in cancer cells that make tumors grow. It is being tested in patients in research~     studies such as this one. As of 2010, more than 80 patients with various types of cancer have~     received treatment with Buparlisib in research studies.~      This clinical research study is divided into two parts. The goal of the first part of this~     study is to learn if the study drug Buparlisib can shrink or slow the growth of cancer in~     patients with urothelial tumors. The goal of the second part of this study is to learn if the~     study drug Buparlisib can shrink or slow the growth of urothelial tumors in patients known to~     have certain genetic alterations that cause these types of tumors. The study doctor will~     inform the patient which part of the study is currently enrolling participants. Participants~     in both parts of the study will receive the same treatment and tests.~      The safety of this drug will also be studied in both parts. The physical state, changes in~     the size of the tumor, and laboratory findings taken while on-study will help us decide if~     Buparlisib is safe and effective.~   "
153966|NCT01551017|"~     Fast Track Recovery Arthroplasty Project is supposed to analyse a new medical method to~     accelerate patient's remobilisation process after total knee endoprostheses. The method,~     called c-treatment, is a computer-controlled cryotherapy (soothing cooling therapy) at which~     the device measures temperature at the affected site (the operated knee in the investigators~     investigation) and optimizes the cooling temperature. The optimized cooling therapy is~     supposed to reduce swelling and postoperative pain whereby patient's postoperative~     mobilization can be done earlier leading to a reduction of length of hospitalization.~      To verify c-treatment's efficiency compared to conventional cryotherapy, patients are split~     in a test group and a standard group. The standard group is treated following the standard~     protocol at the Department of Orthopaedics Surgery Graz using cold packs (Fa. Dahlhausen,~     product code 93.000.00.042). Patient's in the test group receive c-treatment therapy~     following the study protocol.~      All patients are instructed to fill in standardized questionnaires to evaluate social scores~     and pain scores preoperative as well as postoperative. The knee's swelling and range of~     motion as well as blood parameters monitoring the healing process are measured following the~     study protocol.~      The comparison of these parameters between the standard and the test group is supposed to~     verify c-treatment's efficiency.~   "
153967|NCT01551004|"~     Double-blind, randomized, placebo-controlled Phase I Trial to determine the safety and~     pharmokinetics of a single dose of CRS3123 in healthy adult volunteers. Forty healthy male~     and female subjects 18 to 45 years will be admitted in 5 dosing Cohorts, 8 subjects per~     Cohort. Up to two alternates may be used per dosing Cohorts for study subjects that drop out.~     The primary objective of the study is to determine the safety and tolerability of escalating~     doses of CRS3123 following oral administration to healthy subjects.~   "
153968|NCT01550978|"~     The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system~     during the course of mechanical ventilation and intubation of critical care patients in~     Intensive Care Unit.~   "
153969|NCT01550965|"~     This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in~     participants with ulcerative colitis (UC).~   "
153970|NCT01550952|"~     Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain.~     Commonly, patients receive general anesthesia with interscalene block (injection of local~     anesthetic or numbing medicine near nerves in the shoulder) during surgery. As a result of~     the interscalene block, patients often experience sensory and motor blockade. The purpose of~     this study is to determine the effects of the interscalene block on the anterior deltoid~     muscle and hand grip strength after total shoulder arthroplasty.~   "
153971|NCT01550939|"~     The objectives of this study are to determine the time needed to complete a full set of~     measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement)~     by each test device, the Lenstar 900 Version i4 and IOL Master 500.~   "
153972|NCT01550926|"~     The purpose of this study is to determine whether a new dosage form and dose of orlistat is~     equivalent to the currently marketed form.~   "
153973|NCT01550913|"~     This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy (IPT)~     in treating women with depression and comorbid substance abuse.~   "
154120|NCT01548976|"~     The main objective of this study is to perform the linguistic validation of the french~     version of the PISQ-R questionnaire in a population of sexually active (or not) patients who~     have undergone surgery (or not) for stress urinary incontinence or genital prolapse.~   "
189237|NCT01087528|"~     To evaluate the performance of PillCam COLON 2 in regards to detection of patients with~     polyps where colonoscopy is considered as the gold standard reference.~   "
153974|NCT01550900|"~     The goal of this clinical research study is to learn if metformin extended release (ER) can~     prevent colonic adenomas from becoming cancerous. Metformin ER will be compared to a placebo.~      Metformin ER is designed to block a protein in tumor cells that is important in tumor growth~     and blood vessel development. This may cause cell death or reduce the spread of the disease.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
153975|NCT01550887|"~     This study main objective is investigating impulsivity on cocaine or crack addicts. The~     investigators main hypothesis is that different measures (such as scales or behavioral tasks,~     for example) of impulsivity may produce distinct outcomes, and they might also differ among~     cocaine (sniffed) and crack users. Thus, it would be of great value to compare such measures~     once these data are often interpreted as the same phenomenon.~   "
153976|NCT01550874|"~     Epilepsy is common in childhood. Children with epilepsy are at increased risk of impaired~     health, functioning, psychological well-being, and quality of life. There is compelling~     evidence that physical activity improves the medical and psychosocial aspects of health in~     adults with epilepsy - but there are no such studies in children. This study is to see if~     increased levels of physical activity can influence children's functioning, psychological~     well-being, and quality of life.~   "
153977|NCT01550861|"~     The objectives of this study are to evaluate the clinical efficacy of Natural in vitro~     Fertilization and in vitro maturation.~   "
153978|NCT01550848|"~     The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with~     Gemcitabine in the patients with metastatic breast cancer.~   "
153979|NCT01550835|"~     The purpose of this study is to determine whether aspiration thrombectomy following carotid~     stent deployment will reduce the number of procedure related signals as identified by~     diffusion weighted MRI of the brain.~   "
153980|NCT01550822|"~     This lifestyle intervention plan will improve healthy lifestyle practices (diet, exercise,~     and smoking cessation) among stroke survivors and result in a reduction in measures of~     general and abdominal obesity.~   "
153981|NCT01550809|"~     Achieving near-normoglycemia has been established as the main objective for most patients~     with type 1 diabetes (T1DM). However, insulin dosing is an empirical process and its success~     is highly dependent on the patients' and physicians' skills, either with multiple daily~     injections (MDI) or with continuous subcutaneous insulin infusion (CSII, the gold standard of~     insulin treatment).~      Postprandial glucose control is one of the most challenging issues in the everyday diabetes~     care. Indeed, postprandial glucose excursions are the major contributors to plasma glucose~     (PG) variability of subjects with (T1DM) and the poor reproducibility of postprandial glucose~     response is burdensome for both patients and healthcare professionals.~      During the past 10-15 years, there has been an exponentially increasing intrusion of~     technology into diabetes care with the expectation of making life easier for patients with~     diabetes. Some tools have been developed to aid patients in the prandial bolus~     decision-making process, i.e. bolus advisors, which have been implemented in insulin pumps~     and more recently in the newest generations of glucometers. Currently, the availability of~     continuous glucose monitoring (CGM) has opened new scenarios for improving glycemic control~     and increasing understanding of post-prandial glycemic response in patients with diabetes.~      Results from clinical studies suggest that sensor-augmented pumps (SAP)may be effective in~     improving metabolic control, especially when included as part of structured educational~     programs resulting in patients' empowerment. Similarly, preliminary results from pilot~     studies indicate that automated glycemic control, especially during nighttime,based on~     information from CGM is feasible. However, automatic management of meal bolus is currently~     one of the main challenges found in clinical validations of the few existing prototypes of an~     artificial pancreas. Indeed, fully closed-loop systems where information about meals size and~     timing is not given to the system have shown poor performance, with postprandial glucose~     higher and post meal nadir glucose lower than desired. This has promoted other less-ambitious~     approaches, where prandial insulin is administered following meal announcement (semi~     closed-loop). However, despite the use of meal announcement, currently used algorithms for~     glucose control (the so-called PID and MPC), show results that are not yet satisfactory due~     to the risk of producing hypoglycemia.~      One of the limitations of the current open-loop (bolus advisors) and closed-loop control~     strategies is that glycemic variability is not taken into account. As an example, settings of~     CSII consider inter-individual variation of the parameters (insulin/carbohydrates ratio,~     correction dose, etc.) but disregard the day-to-day intra-individual variability of~     postprandial glucose response. Availability of massive amount of information from CGM,~     together with mathematic tools, may allow for the characterization of the individual~     variability and the development of strategies to cope with the uncertainty of the glycemic~     response to a meal.~      In this project, a rigorous clinical testing of a CGM-based, user-independent algorithm for~     prandial insulin administration will be carried out in type 1 diabetic patients treated with~     insulin CSII.~      First of all, an individual patient's model characterizing a 5-hour postprandial period will~     be obtained from a 6-day CGM period. The model will account for a 20% uncertainty in insulin~     sensitivity and 10% variability in the estimation of the ingested carbohydrates. Based on~     this model (derived from CGM), a mealtime insulin dose will be calculated (referred as~     iBolus). Then, the same subjects will undergo standardized meal test studies comparing the~     administration of a traditional bolus (tBolus, based on insulin to CHO ratio, correction~     factor, etc.) with the CGM-based prandial insulin delivery (iBolus).~      Significant advances in postprandial control are expected. Should its efficiency be~     demonstrated clinically, the method could be incorporated in advanced sensor augmented pumps~     as well as feedforward action in closed-loop control algorithms for the artificial pancreas,~     in future work.~   "
153982|NCT01550796|"~     The purpose of this research study is to determine if a medication along with a computer~     program designed to improve memory and other mental processes can help people like yourself~     with tinnitus. The medication that will be investigated, d-cycloserine, was developed as an~     antibiotic. However, more recently, research in other studies has shown that this medication~     may enhance learning and memory. The investigators would like to determine if computer~     programs designed to improve memory and attention are enhanced by this medication. In~     addition, the investigators hope to learn if the use of these programs can help participants~     with their tinnitus as well as their ability to remember and focus. All research participants~     will receive therapy with a computer-based program designed to improve memory and attention.~     Half of participants will also receive d-cycloserine while the other half of participants~     will receive placebo. The placebo is a sugar pill without active medication.~   "
153983|NCT01550783|"~     This randomized clinical trial studies home-based HPV or clinic-based Pap screening for~     cervical cancer. It is not yet known whether home-based screening is more effective,~     cost-effective, and/or acceptable than clinic-based screening for cervical cancer.~   "
153984|NCT01550770|"~     Exploration of the hypothesis that general anesthesia is not a singular threshold but is a~     continuum of central nervous system depression dependent on interpretation of nociceptive~     stimuli.~   "
153985|NCT01550757|"~     Aligning Resources to Care for Homeless Veterans (ARCH) will study ways to best organize~     and deliver primary care for homeless Veterans. The investigators will assess 4 different~     adaptations of the PACT primary care model in a mixed methods study that includes~     multi-center, randomized-controlled trials of embedded peer-mentoring within different~     iterations of the PACT model, focus groups of study participants assessing satisfaction,~     treatment engagement and self-efficacy within the different care models and a cost-utility~     analysis to determine the most cost-efficient approach to organizing care for this~     population. Findings from this study will help determine optimal care approaches for reducing~     emergency department visits and acute hospitalizations, increasing patient satisfaction, and~     improving chronic disease management. Findings from this study will also substantively add to~     our understanding of health seeking behavior and the care of vulnerable/high-risk Veteran~     populations as well as clinical systems design. This project reflects a true field-based~     study to identify optimal and feasible approaches to patient care within our current VHA~     system. Finally, it will help inform pressing policy issues relevant to two identified T-21~     priority areas: Ending Veteran Homelessness in 5 Years and Transforming to a Patient Centered~     Primary Care model.~   "
153986|NCT01550744|"~     The purpose of the study is to assess the effect of extending maintenance dosing intervals~     beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with~     moderate-to-severe plaque psoriasis.~   "
153987|NCT01550731|"~     Millions of diverse Veterans live with severe and chronic illness for which they will face~     complex, ongoing decisions. Although the VHA has been at the forefront of patient-centered~     chronic care, interventions to prepare Veterans for complex decision-making over the course~     of chronic illness are lacking. This proposal addresses this gap by testing the efficacy of a~     novel preparation guide designed to prepare Veterans to communicate with their surrogates and~     to work with clinicians to make complex, ongoing decisions. The multi-media guide teaches~     communication and preparation skill behaviors (e.g., how to choose a surrogate and ask~     clinicians questions) in a culturally appropriate, easy-to-use format (targeted to a 5th~     grade reading level). This study aims to provide an impetus for changing the paradigm of~     advance care planning policies within the VA by moving beyond documentation of end-of-life~     wishes to the activation of Veterans to participate in ongoing communication of their values~     and goals - a process that is essential to fully realize patient-centered care.~   "
154187|NCT01548105|"~     Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found~     to be associated with severe POP. The authors' proposed explanation was that smoking impairs~     tissue and wound healing. Our primary objective is to document whether smokers with pelvic~     organ prolapse (POP) are different from non-smokers with POP with respect to collagen~     biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.~   "
153988|NCT01550718|"~     Alzheimer's disease (AD) is increasing exponentially, with a projected quadrupling of cases~     by the mid 21st century. Individuals with AD are at increased risk for a host of medical and~     psychiatric conditions, and evidence is accumulating supporting the efficacy and~     effectiveness of psychosocial interventions for improving their mood, function, health, and~     quality of life. Such interventions are likely to be most effective when they are implemented~     during the early stages of dementia, when individuals and their family members are coping~     with the initial diagnosis and associated changes in abilities and activities. Recent~     randomized clinical trials by the Principal Investigator and colleagues have developed two~     non-pharmacologic interventions to reduce the social, psychological, physical, and behavioral~     impact of dementia. This investigation is focused on facilitating their translation into~     ongoing community-based programs, such as those provided by Alzheimer's Association chapters,~     senior centers, retirement homes, and other health care providers. The core content of each~     intervention has been retained in order to maintain or improve their efficacy, and each has~     been modified to a 4-week group format to increase efficiency of delivery. These modified~     interventions (ESML-Social and ESML-Ex) will be compared to each other and to a usual care~     (UC) control group. Outcomes will be assessed at baseline, 1-month post treatment, and 4~     month follow-up. Primary outcomes at the 1-month assessment include: social activity~     participation, family communication, physical activity participation, and physical function.~     Primary outcomes at 4-month follow up include overall quality of life and depression. It is~     hypothesized that ESML-Ex and ESML-Social both will have greater improvements than UC. It is~     hypothesized that ESML-Social will have greater improvements in social participation and~     family communication than ESML-Ex and UC. It is hypothesized that ESML-Ex will have greater~     improvements in physical activity participation and physical functioning than ESML-Social and~     UC. If successful, these 4-week programs may be developed into modules that can be~     incorporated into programming for individuals with early stage dementia in a variety of~     community settings.~   "
153989|NCT01550705|"~     In erythropoietic protoporphyria there is an accumulation of protoporphyrin IX (PPIX) in the~     plasma and liver. The reason it builds up is either the last step to make heme, insertion of~     iron into PPIX, is rate limiting or there is an increase in activity in the first step in the~     heme pathway.~      It may be possible to decrease the amount of PPIX made and see a decrease in symptoms. The~     first step to make heme is the key step in the pathway and it uses vitamin B6 as a cofactor.~     If the investigators can limit the amount of vitamin B6 the investigators can possibly reduce~     the activity of this rate limiting step. With decreased activity of the enzyme it may be~     possible for the body to utilize all the PPIX that is made so that none builds up.~   "
153990|NCT01550679|"~     Even though the main risk factor for the development of chronic obstructive pulmonary disease~     (COPD) is smoking only in less than one third of the smokers the clinically manifest COPD~     will develop. The disease progressive nature with high disability and mortality especially in~     the final stages makes it plausible to detect the disease as early as possible thus allowing~     for the early intervention. Major intervention trials in COPD, Towards a Revolution in COPD~     Health (TORCH), Investigating New Standards for Prophylaxis in Reducing Exacerbations~     (INSPIRE), and Understanding Potential Long-term Impacts on Function with Tiotropium~     (UPLIFT) have recently shown that the beneficial impact of intervention was larger in~     patients being treated in earlier stages of the disease development. Till now the only tool~     for an early diagnosis and early intervention that could be used on the global scale was~     spirometry even though symptoms and deprivation of quality of life (QoL) precedes clinically~     relevant spirometric changes. So there is a need for a new simple tool that would allow~     detection of patients in a very early stage of COPD.~      So the aim of this study is the development of diagnostic tools for an early detection of~     COPD, even before the significant change in spirometry.~   "
153991|NCT01550666|"~     People with schizophrenia often have problems with negative symptoms; expressing and~     identifying their emotions, their amount of speech, motivation and interests, feelings of~     purpose, social skills, and experiencing enjoyment. For this reason, new interventions are~     being developed to treat these problems. One new intervention is the Motivation and~     Engagement (MOVE) Program. The MOVE program is a new program which consists of weekly~     meetings for 9 months between a patient and a trainer. The weekly meetings will consist of~     goal setting and organization of the home to make daily tasks more manageable. During the~     weekly meetings the patient and trainer will discuss emotions and the trainer will help the~     patient identify their emotions.~      The researchers hope to learn whether MOVE will help improve the problems. If it works the~     researchers will do a larger study comparing MOVE to other treatments that have addressed~     some of the problems already.~      The therapist will ask you if the sessions can be audio taped to ensure that the therapist is~     doing a helpful job for you. They will also ask if the session can be video taped so that the~     tapes can be used to train other therapists learning about MOVE. The choice to do either of~     these is voluntary and you can continue to participate in the study if you choose not to have~     the session be audio and/or video taped.You will be provided a University Release document to~     provide that permission if you so choose.~   "
153992|NCT01550653|"~     This study examines the hypothesis, that subcutaneous administration of liraglutide, an~     analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in~     healthy humans.~   "
153993|NCT01550640|"~     Caesarean delivery under general anaesthesia (GA) carries nowadays still 25% risk of~     insufficient depth of anaesthesia in a time before the fetus delivery. The reason is the lack~     of opioid administration. Opioids easily cross placental barrier and negatively influence~     newborn postpartum adaptation by respiratory depression. Introduction to GA is thus~     accompanied by exaggerated autonomic stress reaction with hypertension and tachycardia. The~     use of ultra-short acting opioid remifentanil should suppress stress response in mother~     without increasing the risk for newborn. There are only a few clinical data available. This~     study will be the first one systematically studying the influence of remifentanil in pregnant~     women with hypertension on hemodynamic stability and newborns safety. This study will also~     identify potential pharmacogenetic factors of individual variability in remifentanil response~     with respect of drug efficacy and safety in mother and newborn.~   "
153994|NCT01550627|"~     The aim of the study was to evaluate the influence of a systematic extra intravenous fluid~     supplementation during phototherapy in comparison to a fluid supplementation due to short~     term demand in preterm infants.~   "
153995|NCT01550614|"~     The purpose of this study is to determine whether a single intracoronary infusion of~     Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial~     perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8~     weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary~     endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size.~   "
154188|NCT01548092|"~     The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the~     treatment of recto-vaginal fistula.~   "
154882|NCT01538979|"~     The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It~     will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off~     allergy symptoms over a two year study period.~   "
153996|NCT01550601|"~     The bariatric surgery is recognized, at present, as the only effective therapeutic for the~     patients with morbid obesity. Two surgical procedures (said restrictive) are considered as~     consensual: the adjustable calibrated horizontal gastroplasty under laparoscopy (ring~     périgastric) and Gastric Bypass under laparoscopy (LGBP). The longitudinal gastrectomy~     (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008). It~     consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/-~     antrum). However, lot of technical disagreements are brought back by expert teams. The most~     important disagreement concerns the conservation or the exeresis of the gastric antrum. In~     fact, the conservation of gastric antrum could facilitate the gastric emptying and to~     decrease the RGO (main complication) and act on the regulations of hormones modulators of the~     insulino-secretion.~      A prospective,randomized study comparing these both techniques is necessary to determine a~     unique consensual technique~   "
153997|NCT01550588|"~     Background and hypothesis:~      The appropriate treatment strategy for secondary stroke prevention in patients with~     cryptogenic stroke and patent foramen ovale (PFO) remains challenging. Clinical and~     anatomical variables reported to be risk factors associated with stroke recurrence include~     older age, large PFO, large right-to-left shunting, and combined atrial septal aneurysm~     (ASA), which, however, were not confirmed by other studies. The investigators hypothesized~     that percutaneous closure of PFO could be an effective option for secondary prevention in~     cryptogenic stroke patients with high-risk PFO.~      Trial Objective:~      The primary objective of this study is to assess whether percutaneous device closure of PFO~     is superior to conventional antithrombotic treatment in preventing stroke recurrence in the~     cryptogenic stroke patients with high-risk PFO.~   "
153998|NCT01550575|"~     This study will evaluate deidentified (anonymous) data in subject medical charts to review~     the clinical outcomes of spinal cord stimulation.~   "
153999|NCT01550562|"~     The purpose of this study is to investigate the effects of varying programming parameters in~     subthreshold spinal cord stimulation therapy for pain relief.~   "
154000|NCT01550549|"~     This study will investigate the performance of physician readers trained to read~     florbetapir-PET scans using electronic media training.~   "
154001|NCT01550536|"~     The primary purpose of this study is to expand research on the effects of physical activity~     on basal metabolic rate (BMR) in healthy postmenopausal women, and to further compare the~     effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training~     program. The investigators will measure BMR by indirect calorimetry and normalize it across~     subjects for body size (fat free mass) and level of aerobic fitness (VO2MAX). Two groups will~     be compared: an intervention group (no previous participation in regular exercise, newly~     enrolled in this study's 16 week training program), and a long-term athlete group (have~     engaged in at least 5 hours of exercise per week for the past 10 years or longer). A~     secondary aim is to generate an equation for the prediction of BMR from fat free mass in~     physically active postmenopausal women, to be applied to hypotheses in biological~     anthropology. The investigators expect to find at baseline that, controlling for fat free~     mass and VO2MAX, the long-term group will have significantly higher BMR than the intervention~     group. At 16 weeks the investigators expect no change in BMR for the long-term group, while~     BMR will have increased in the intervention group. At the same time, the investigators expect~     to find that after completing the training regimen, the intervention group will have BMR~     similar to that of the long-term athletes.~   "
154002|NCT01550523|"~     This human Phase I trial involves taking the patient's own tumor cells during surgical~     craniotomy, treating them with an investigational new drug (an antisense molecule) designed~     to shut down a targeted surface receptor protein, and re-implanting the cells, now~     encapsulated in small diffusion chambers the size of a dime in the patient's abdomen within~     24 hours after the surgery. Loss of the surface receptor causes the tumor cells to die in a~     process called apoptosis. As the tumor cells die, they release small particles called~     exosomes, each full of tumor antigens. It is believed that these exosomes as well as the~     presence of the antisense molecule work together to activate the immune system against the~     tumor as they slowly diffuse out of the chamber. This combination product therefore serves as~     a slow-release antigen depot. Immune cells are immediately available for activation outside~     of the chamber because a wound was created to implant these tumor cells and a foreign body~     (the chamber) is present in the wound. The wound and the chamber fortify the initial immune~     response which eventually leads to the activation of immune system T cells that attack and~     eliminate the tumor. By training the immune system to recognize the tumor, the patient is~     also protected through immune surveillance from later tumor growth should the tumor recur.~     Compared to the other immunotherapy strategies, this treatment marshalls the native immune~     system (specifically the antigen presenting cells, or dendritic cells) rather than~     engineering the differentiation of these immune cells and re-injecting them. Compared to~     traditional treatment alternatives for tumor recurrence, including a boost of further~     radiation and more chemotherapy, this treatment represents potentially greater benefit with~     fewer risks.~      This combination product serves as a therapeutic vaccine with an acceptable safety profile,~     which activates an anti-tumor adaptive immune response resulting in radiographic tumor~     regression.~   "
154003|NCT01550510|"~     This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment~     with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced~     colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy.~     This study will be conducted as an amendment to Investigational New Drug # 77486.~   "
154004|NCT01550497|"~     1. Do spinal stabilization exercises demonstrate immediate and long-term effects of weight~          weeks of spinal stabilization exercises as measured by pain intensity and quality of~          life scores?~        2. Does eight weeks of spinal stabilization exercises improve back muscle endurance in~          adolescents with Idiopathic Scoliosis (IS) with low back pain (LBP), compared to a~          one-time treatment (control)?~      Hypotheses:~      The research hypothesis for Question 1 is: Participants who receive eight weeks of spinal~     stabilization exercises will demonstrate significantly improved pain intensity and quality of~     life scores compared to participants who receive a one-time treatment after eight weeks of~     the intervention period and at six-month follow-up.~      The research hypothesis for Question 2 is: Participants who receive eight weeks of the spinal~     stabilization exercises will demonstrate significantly improved back muscle endurance,~     compared to participants who receive a one-time treatment after eight weeks of intervention.~   "
154005|NCT01550484|"~     The purpose of this study is to determine whether 18F-AV-133 PET scans can be used to~     differentiate subjects with Parkinson's Disease from other movement disorders.~   "
154201|NCT01547923|"~     The aim of this study is to demonstrate the medical and financial benefit of pre-therapeutic~     screening of DPD deficiency for predicting toxicity to fluoropyrimidines.~   "
154202|NCT01547910|"~     The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with~     non-alcoholic fatty liver disease.~   "
154006|NCT01550471|"~     This study will provide the clinicians guidance on the safest combination of inhaled and~     nasal corticosteroids for children with mild asthma and allergic rhinitis respectively;~     however, one safety concern is that these products are independently known to have~     dose-related effects on short term and intermediate term growth. Knemometry is a non invasive~     technique for measuring short-term lower leg growth in children and is currently the method~     of choice in growth studies of short duration. Subjects will be seen on a weekly basis for 18~     weeks and at each visit, lower leg length will be measured using knemometry.~   "
154007|NCT01550458|"~     The objective of the study is to determine the safety and pharmacokinetics of a 7 day course~     of oral mibefradil given four times a day in healthy volunteers. This is a dose escalation~     study in which the total daily dose of mibefradil will be increased with each cohort.~   "
154008|NCT01550445|"~     The investigators analyze the clinical outcome of steroid withdrawal protocol starting at 3~     months after kidney transplantation using tacrolimus, Mycophenolate Mofetil (MMF), and~     basiliximab. This study is an open-label, prospective, controlled clinical trial in a single~     center. Those patients who fulfill the entry criteria could enter in this prospective~     controlled trial of steroid withdrawal three months after transplantation.~   "
154009|NCT01550432|"~     The rationale for the potential role of antioxidants in the prevention of cardiovascular~     diseases (CVD) remains strong despite the disappointing results of recent trials with a few~     select antioxidant vitamins. Glutathione (GSH) is one of the body's most powerful antioxidant~     agents but there is a surprising paucity of data on its use as an interventional therapy.~      Glutathione, when taken orally, is immediately broken down into its constituent amino acids,~     of which cysteine is the only one to be essential. Available cysteine is the critical~     determinant of intracellular GSH concentrations. N-acetyl cysteine (NAC) is an antioxidant~     supplement that has been used to provide a source of cysteine to replete GSH levels. By~     replenishing endogenous glutathione, it is possible that NAC would exert the same effect(s)~     as exogenous GSH.~      However, there is a new delivery system, liposomal GSH, which keeps glutathione intact. In~     this study, the investigators propose to match the cysteine content of NAC and GSH and~     compare the effects of these two supplements, at two different doses, on markers of~     inflammation and oxidative stress.~   "
154010|NCT01550419|"~     Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in~     ventilated critically ill patients specially in intensive care unit (ICU). It is associated~     with an increased duration of mechanical ventilation, high death rates and increased~     healthcare costs in China. However, VAP is preventable and many practices have been~     demonstrated to reduce the incidence of this disease, but the morbidity is still so high. So~     much more methods of prevention should be needed to reduce the incidence of VAP.~      Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) present~     anti-inflammatory and immunomodulatory effects besides their ability to regulate cholesterol~     composition. So it is hypothesized that early use of statin may prevent some of the infection~     disease such as VAP.~      Actually, Two studies have showed that statin treatment is associated with reduced risk of~     pneumonia. However, the relationship between statins and reduced risk of pneumonia is not~     consistent.~      After reviewing some of the guidelines,meta analyses and system reviews, the investigator~     find that advanced age,immune suppression from disease or medication and specially depressed~     level of consciousness are the risk factors of VAP. So the investigator assumes that early~     use of statin may give us a favorable outcome in the patients with coma or in the patients~     with severe disease (Acute Physiology and Chronic Health Evaluation II score > 15 or Glasgow~     coma score < 7).~      In addition there is no prospective study to investigate the role of statins in VAP in the~     patients with ischemic stroke. The investigator hopes that this study can approve the~     relationship between statins and reduced risk of VAP in the patients with ischemic stroke.~     And it can improve the processes,outcomes and costs of critical care as well.~   "
154011|NCT01550406|"~     To date, there has been many methods suggested to reduce pancreatic fistula. But there are no~     evidence of superiority to the other methods. This study is a multicenter prospective~     randomized phase III study of use of Tachocomb or Polyethylene Glycolic Acid (PGA) to prevent~     of pancreatic fistula after distal pancreatectomy.~   "
154012|NCT01550393|"~     RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help~     doctors identify biomarkers related to cancer.~      PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.~   "
154013|NCT01550380|"~     This is a phase II open label fixed dose study in subjects with advanced, metastatic, or~     refractory endometrial or ovarian, fallopian tube, or primary peritoneal cancer with PI3~     kinase pathway activation as demonstrated by PIK3CA gene mutation, PTEN gene mutation, or~     PTEN null/low protein expression.~   "
154014|NCT01550367|"~     The main goal of the research study is to determine whether treating renal cell cancer~     patients with the study drug, hydroxychloroquine, along with IL-2, a standard treatment of~     kidney cancer that has spread to other parts of the body, can make the cancer easier to kill~     and eliminate. Another goal is to see how the study drug affects the body's immune cells~     which fight cancer cells.~   "
154015|NCT01550354|"~     Several methods have been demonstrated to improve intubating conditions during sevoflurane~     induction in children. These include opioids, propofol, and addition of neuromuscular~     blocking agents in pediatric patients. But the study about the comparison of these agents has~     been uncommon. Frenectomy is common procedure to treat ankyloglossia. It is a short procedure~     performed under general anesthesia. The investigators aimed to compare intubating conditions~     among children with propofol, alfentanil or rocuronium after sevoflurane induction.~   "
154016|NCT01550341|"~     As of July, 2014 the study aims have changed. The revised project, called STRIDE2, is a~     longitudinal, non-randomized, observational study of individuals living with HIV who are~     dependent on opioids. This study is funded by the National Institute on Drug Abuse~     (R01DA030768, Altice, PI; Taxman & Lawson, Co-PIs) and is being conducted by George Mason~     University, Yale University, and Howard University. Those individuals originally enrolled in~     the STRIDE RCT will be followed for 12 months.~   "
154017|NCT01550328|"~     The primary objective is to identify device characteristics, components or subsystems that~     manifest as screening score bias in SCOUT DS.~   "
158304|NCT01493960|"~     The purpose of this study is to determine if cobitolimod (former called Kappaproct®) is~     effective in the treatment of chronic active ulcerative colitis patients not responding to~     available therapy.~   "
154019|NCT01550302|"~     The investigators want to know whether injecting numbing medication on the side of the neck~     (also called superficial cervical plexus block) can prevent or reduce shoulder pain that~     patients commonly experience after lung surgery. The investigators will perform the injection~     at the end of your surgery while the subjects are still under general anesthesia and before~     they wake up. The investigators will use a local anesthetic (bupivacaine or Marcaine®) that~     is routinely used for skin infiltration of the surgical wounds.~      This study is randomized and single-blind. This means that subjects will be assigned by~     chance (like flipping a coin) to receive either an injection with active medication~     (bupivacaine), or no injection at all.~   "
154020|NCT01550289|"~     The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine~     in India adult subjects.~      Primary Objectives:~        -  To describe the neutralizing antibody response to each dengue virus serotype before the~          first vaccination and after each vaccination with CYD dengue vaccine in all subjects.~        -  To describe the safety of the CYD dengue vaccine after each dose in all subjects.~      Secondary Objective:~        -  To detect symptomatic dengue cases occurring at any time in the trial.~   "
154021|NCT01550276|"~     Background. Headache is one of the most common causes of consultation in primary health care~     and neurology in Europe. Cervical muscle tension can maintain a restriction of joint motion~     at the suboccipital level, facilitating the referred head pain.~      Objective. To evaluate the effectiveness of two manual therapy treatments for tension-type~     headache.~      Methods. A randomized double-blind clinical trial was conducted, for a period of 4 weeks and~     a follow-up at one month post-treatment. Eighty-four patients with tension-type headache were~     assigned to 4 groups (3 treatment groups and 1 control group). Treatments included manual~     therapy of suboccipital soft tissue inhibition, occiput-atlas-axis global manipulation, and a~     combination of both techniques. Outcome measures were: impact of headache, disability caused~     by headache, ranges of motion of the craniocervical junction, frequency and intensity of~     headache, and associated headache symptoms.~      Results. After 8 weeks, there were significant improvements in impact of headache (p=0.01),~     disability (p=0.001), and craniocervical flexion (p=0.03) for the suboccipital soft tissue~     inhibition group; in headache impact and disability (p=0.000), pain intensity (p=0.02) and~     craniocervical flexion (p=0.004) and extension (p=0.04) for the occiput-atlas-axis group; and~     in impact (p=0.002), functional disability (p=0.000), headache frequency (p=0.002) and~     intensity (p=0.001), craniocervical flexion (p=0.008) and extension (p=0.003) and associated~     headache symptoms (p=0.01) for the combined therapy group, with effect sizes from medium to~     large.~      Conclusions. Occiput-atlas-axis and combined therapy group treatments are more effective than~     suboccipital soft tissue inhibition for tension-type headache. The treatment with~     suboccipital soft tissue inhibition, despite producing less significant results, also has~     positive effects on different aspects of headache.~   "
154022|NCT01550263|"~     This is an investigatory study to determine whether high levels of pre-operative~     psychological distress predict worse outcomes after hip preservation. This is a low risk~     study and does not alter the treatment or course of care for patients undergoing this~     procedure~   "
154023|NCT01550250|"~     Women who have undergone breast cancer surgery may develop swelling of the arm on the side~     the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This~     study will examine night-time compression system garments for lymphedema. Our objective is to~     determine if breast cancer survivors are willing and able to use the garment overnight to~     help control their lymphedema. Thirty breast cancer survivors from Alberta will be enrolled~     in the 24-week long study. Measurements will be taken of each arm to assess the extent of~     lymphedema and to measure changes over the study period. We will also examine other outcomes~     such as the impact of the night-time compression system garment on sleep. The study will~     provide important information on the feasibility of night-time compression system garments as~     a self-management strategy for lymphedema.~   "
154024|NCT01550237|"~     The clinical importance of cone beam computer tomography based image guided radiotherapy (CT-~     IGRT) has not been established. The primary aim of the present trial is to investigate~     whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from~     curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning~     target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as~     secondary outcome.~      An open randomised phase III trial. The included men will be randomised to receive curative~     radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and~     standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position~     verification and reduced safety margins (7mm).~   "
154025|NCT01550224|"~     The purpose of the study is to first determine if temozolomide plus vorinostat in combination~     can control relapsed or refractory acute myeloid leukemia (AML) and determine if this~     combination can be safely taken. The study will look at the side effects of the Temozolomide~     plus Vorinostat in combination and whether the treatment schedule is tolerated.~   "
154026|NCT01550211|"~     This study aims to identify electrophysiological correlates of impaired perceptual and~     linguistic processes in chronic schizophrenic patients, un-medicated first-episode~     schizophrenic patients and their healthy relatives.~      Following administrating some questionnaires (demographic details and psychiatric history~     questionnaire, handedness questionnaire, reading abilities test and positive and negative~     symptoms questionnaire) and performing a perception test and a verbal abstract intelligence~     test, participants will conduct a brain scan during a series of perceptual and linguistic~     tasks.~   "
154027|NCT01550198|"~     The purpose of this study is to evaluate the hypothesis that advanced hemodynamic monitoring~     results in an earlier detection of circulatory failure in newborn infants~   "
154028|NCT01550185|"~     The purpose of this study is to find out the highest safe dose and examine the side effects~     and effectiveness of eltrombopag olamine in patients with acute myeloid leukemia (AML)~     treated with chemotherapy that have not responded to previous therapy or have suffered a~     relapse~   "
154029|NCT01550172|"~     The purpose of the study is to determine whether a combined intervention of a night home~     monitoring system and cognitive-behavioral therapy for insomnia (CBTi) is effective in~     improving sleep in dementia caregivers who arise at night.~   "
154030|NCT01550159|"~     This study aims to evaluate the possible Correlation Between Serum Levels of Markers of~     Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery.~   "
154031|NCT01550146|"~     Fracture neck of femur is a common cause of hospital admission in the elderly and requires~     operative fixation.~      Dexamethasone has the potential of inhibiting cortisol secretion. In addition, preoperative~     glucocorticoids improve analgesia and decrease opioid consumption with reduction in~     associated side effects in a variety of clinical settings.~      The investigators hypothesis was that a single dose of preoperative dexamethasone enhance~     postoperative analgesia and attenuates the inflammatory response in patients undergoing~     operative fixation of fractured neck of femur, in a prospective, randomized, placebo~     controled trial.~   "
190261|NCT01074086|"~     A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML~     treatment of patients older less than 65 years in relapse~   "
154032|NCT01550133|"~     This study has two main aims: 1) To determine if ingestion of solid or beverage food forms~     will change appetite hormone responses, and 2) To determine whether learning (defined as 2~     week daily consumption) about the metabolic consequence of ingesting solid or beverage foods~     forms varying in energy alters appetite hormone responses.~      Beverage consumption has been implicated in the problem of obesity. However, the exact~     relationship between beverages, lower appetitive response and lower compensatory dietary~     responses remains unclear. This study aims to address this gap in the research. For aim 1,~     the null hypothesis is that the energy in beverage and solid forms will not affect appetite~     hormonal responses differently. The alternative hypothesis is that exposure to the~     energy-yielding beverage will elicit a lower appetitive hormone response compared to oral~     exposure to the solid food form. For aim 2, the null hypothesis is that learning will not~     change appetite hormone responses. The alternative hypothesis is that learning will decrease~     appetite hormone responses in the non-energy-yielding beverage more than in the~     energy-yielding beverage.~   "
154033|NCT01550120|"~     This study seeks to determine if non-esterified fatty acid (NEFA) taste detection thresholds~     change with repeated testing. Threshold testing for NEFA taste has been reported by a number~     of laboratories, including our own; however, these studies have reported data for only one~     testing occasion. The investigators seek to conduct repeated testing to measure the~     test-retest reliability of these methods. The investigators believe that with repeated~     exposure to NEFA, a person's sensitivity increases. The investigators are also testing the~     efficiency of testing by two methods (forced-choice ascending trial versus staircase).~     Additionally, the association between taste responses, diet and BMI will be explored.~   "
154034|NCT01550107|"~     Sarcopenia is defined as the presence of low muscle mass and either decreased muscle strength~     or function. It is increasingly becoming a significant cause of frailty, loss of independence~     and physical disability in ageing western populations. Recent experimental evidence has~     revealed that skeletal muscle is particularly susceptible to damaging molecules that result~     in oxidative stress and that oxidative stress plays a prominent role in the development and~     progression of sarcopenia. The investigators have previously shown that the xanthine oxidase~     inhibitor allopurinol is able to abolish vascular oxidative stress and improve endothelial~     function in cohorts such as optimally treated chronic heart failure and chronic kidney~     disease. Recently, the investigators have also shown that allopurinol improves exercise~     tolerance and time to ST-depression in optimally treated coronary artery disease, suggesting~     that allopurinol could also exert its effects through ATP and/or oxygen sparing mechanisms.~      Therefore, we propose a randomised double blind placebo-controlled parallel group trial of~     allopurinol in patients with primary sarcopenia using MR-spectroscopy and Flow Mediated~     Dilatation to investigate the possible mechanisms that underlie this exciting possibility~   "
154035|NCT01550094|"~     One technique for the nerve block involves injecting the numbing medicine where the nerve is~     together (higher up in the back of the thigh). The other technique involves injecting the~     numbing medicine where the nerve splits into two parts. By injecting numbing medication~     around the nerve(s), there will be less pain after the procedure. It is thought that the~     numbing medicine will be easier to inject in the group that the nerves are split. It is~     expected that subjects may need less pain medication and have lower pain ratings in this~     group too.~   "
154036|NCT01550081|"~     Aerobic interval training is shown to be superior in increasing oxygen uptake in both healthy~     and patients with coronary artery disease (CAD), compared to moderate continuous training.~     However, in cardiac rehabilitation exercise groups, exercise intensity is usually controlled~     with perceived exertion (Borg scale). The investigators will investigate degree of agreement~     between target heart rate and perceived exertion during interval training in cardiac~     rehabilitation.~   "
154037|NCT01550068|"~     Acute rheumatic Fever (ARF) results from an autoimmune response due to molecular mimicry~     between the M-protein on the group A β-hemolytic streptococci (GABHS) cell membrane and~     cardiac myosin, and may lead through recurrent or sustained inflammation to Rheumatic Heart~     Disease (RHD). RHD remains a major contributor to morbidity and premature death in the~     working age population in Nepal. Secondary prevention with regular oral or intravenous~     administration of penicillin continued until early adulthood is recommended to prevent the~     progression of the development of endocarditis and subsequent valvular dysfunction.~      Screening for rheumatic heart disease using echocardiography has the potential to detect~     rheumatic valvular lesions at an earlier, clinically silent stage, as compared to clinical~     examination alone and might have a beneficial impact on long-term outcome of children with~     RHD. Schoolchildren aged 5-15 years from several public and private schools from rural and~     urban areas in Southeastern Nepal will be screened for RHD using portable echocardiography.~      Three main inter-related objectives will be pursued in three phases of the study: In a first~     phase using a cross sectional approach, the prevalence of clinical and subclinical RHD will~     be investigated among a representative sample of schoolchildren from public and private~     schools in urban and rural areas. In a second phase, using a cohort study approach among~     those children diagnosed at different stages of RHD, clinical outcomes with regular medical~     surveillance will be assessed (a), and clinical and social risk factors associated with~     prognosis of the disease after receiving medical care at various stages of disease at~     diagnosis will be determined (b). A third phase will integrate the prevalence rates from~     phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact~     of screening and RHD treatment on health resource utilization.~   "
154038|NCT01550055|"~     The primary purpose of this study is to evaluate the clinical response and safety of~     cetuximab plus irinotecan synchronously/subsequently in patients with KRAS wild-type~     metastatic colorectal cancer~   "
154039|NCT01550042|"~     Recent studies demonstrated that prolonged rhythm observation increases the detection of~     atrial fibrillation in patients prior diagnosed as cryptogenic stroke. Detection of atrial~     fibrillation in these patients has important therapeutic implications for the anticoagulation~     regimen. However, data on optimal monitoring duration and method of AF detection are limited.~   "
154040|NCT01550029|"~     The purpose of this research is to develop and test a new type of smoking cessation~     counseling for individuals with bipolar disorder.~   "
154065|NCT01549691|"~     The purpose of this study is to test the level of anxiety in patients, the day before surgery~     (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.~        -  one receiving placebo before going to sleep (before sleep), the day prior surgery and~          placebo when awakening (awakening), the day of surgery~        -  one receiving zopiclone (7.5 mg) before sleep and placebo at awakening~        -  one receiving placebo before sleep and alprazolam (0.5 mg)at awakening~      double blind, randomized controlled study~   "
154066|NCT01549678|"~     The hypothesis to be tested is that the use of total contact insoles for six months reduces~     foot pain, improves function and quality of life of patients diagnosed with plantar~     fasciitis.~   "
154041|NCT01550016|"~     Improvements in diagnosis of dengue fever and prediction of which patients will get more~     severe disease are urgently needed to improve the treatment of patients with dengue. This is~     very important in places with many people who suffer from dengue but have limited health care~     resources. This study will enroll patients with fever which may be caused by dengue in 6~     countries with high incidence of dengue over two continents (Brazil, Cambodia, El Salvador,~     Indonesia, Malaysia and Vietnam). All patients will be followed by a doctor with blood tests~     and exams until they recover. Symptoms and laboratory tests will be followed so that the~     cause of fever can be determined. For patients who have dengue, the investigators will look~     for symptoms and tests which indicate more serious disease. This study will help to determine~     how to identify patients with dengue fever based on symptoms and simple laboratory tests and~     those who will get more serious disease. It will also help to define a more standardized~     management of patients with dengue fever.~   "
154042|NCT01550003|"~     A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of~     Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active~     Polyarticular-course Juvenile Idiopathic Arthritis (JIA).~   "
154043|NCT01549990|"~     Living-donor kidney transplantation has been considered as the best treatment for patients~     with end-stage renal disease (ESRD). Kidney donation from living donors has been performed~     widely under their noble humanity and a belief that donation would not harm the donor.~     Although the overall evidences proposed that living kidney donor have medical outcomes~     similar to those in general population, several reports have demonstrated the potential risks~     for development of hypertension, proteinuria, and ESRD. Thus, all efforts should be~     concentrated on ensuring their safety and preserving the function of their remained kidney~     during anesthesia maintenance.~      Inhaled anesthetics have been frequently used for the induction and maintenance of general~     anesthesia. The metabolism of certain inhaled anesthetics can produce inorganic fluoride,~     which may be directly nephrotoxic through impairments of renal concentrating ability. The~     typical inhaled anesthetics commonly used nowadays are sevoflurane and desflurane. The~     defluorination of sevoflurane can results in increased serum inorganic fluoride ion~     concentrations, but any neprhotoxic effect of sevoflurane has not been proven yet in human.~     On the other hand, desflurane is extremely resistant to defluorination, and desflurane does~     not appear to be nephrotoxic.~      The inhaled anesthetics which are currently used in general anesthesia have no clinical~     evidence of nephrotoxicity, but the possible risks cannot be excluded entirely, especially in~     the patients who one kidney is donated. The purpose of the current retrospective, single~     center study was to evaluate and compare postoperative renal function of living kidney donor~     after nephrectomy under sevoflurane or desflurane anesthesia, and make evidence-based~     recommendations of proper inhaled anesthetics for anesthesia of living kidney donor.~   "
154044|NCT01549977|"~     The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared~     to placebo as an add on to stable anti-anginal therapy, on the total exercise time of~     participants with Chronic Stable Angina.~   "
154045|NCT01549964|"~     The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50~     mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus~     metformin on lowering blood sugar.~   "
154046|NCT01549951|"~     The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to~     investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with~     Metastatic Castration-Resistant Prostrate Cancer~   "
154047|NCT01549938|"~     This is a feasibility double-blind randomised controlled trial in 32 participants. It~     evaluates the feasibility of a full trial which will examine the efficacy of weekly~     supplementation of cholecalciferol (vitamin D3) relative to placebo on the subsequent~     frequency and severity of objectively-verified symptomatic acute respiratory tract infection,~     overall and as a proportion of detected colonisations of the upper respiratory tract by 9 of~     the most common aetiologic viral pathogens.~   "
154048|NCT01549925|"~     The objective of this prospective randomized surgical trial is to evaluate whether the use of~     the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with~     ovarian cancer will reduce the surgical time compared to standard surgical resection using~     clamps and surgical ligatures.~   "
154049|NCT01549912|"~     The primary objective of this research is to examine the result of rotator cuff repairs~     following acute shoulder dislocations and to investigate whether timing of surgery following~     acute shoulder dislocations affects patients perception of pain, function, and strength~     following surgery.~   "
154050|NCT01549899|"~     The objective of this study is to directly compare 6 sessions of in-person and Internet~     administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control~     (MC), within an active duty military population to determine the comparative benefits of~     these interventions on improvement in sleep as well as domains strongly related to insomnia~     such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel~     with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions~     (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The~     investigators will compare these three groups on subjective and objective measures of sleep.~     The CBTi and MC control groups will be compared on other variables of interest (e.g.,~     depression, substance abuse, and PTSD symptoms) and predictors of outcomes.~   "
154051|NCT01549886|"~     The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen~     compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade~     or follicular NHL.~      Effectiveness of the experimental regimen will be assessed by complete response rate within 6~     months of study entry (primary endpoint), complete response rate within 3 months of study~     entry, and overall response rate within 6 month of study entry.~   "
154052|NCT01549873|"~     When patients have spinal surgery, electrodes are placed on the body to measure motor evoked~     potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV~     anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At~     this hospital the investigators typically use inhaled anesthesia and are able to successfully~     measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than~     the other for measuring MEP and SSEP.~   "
165375|NCT01401088|"~     The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial~     Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory~     glaucoma.~   "
154056|NCT01549808|"~     Abstract Many patients experience serious reduced functional ability after a critical illness~     and hospitalization in an Intensive Care Unit. The cause of the reduced functional ability is~     the combination of critical illness and immobilization following treatment with a ventilator.~     The functional ability of patients can be affected up till a year after the discharge, and~     may shows a decrease in ability to walk and in problems with focusing.~      Studies show that it is safe and possible to mobilize the patients with for instance bed~     bikes, sitting up and standing up, even during ventilator therapy. The effect is shown as~     lesser days with delirium, on a ventilator therapy or hospitalization. No study has shown how~     early and at which intensity a patient can be mobilized. Our hypothesis is that an early~     systematic mobilization improves functional ability of the critically ill patient, mentally,~     physically and their life expectancy. The purpose of this study is to evaluate a mobilization~     protocol applied at critically ill patients, including a contribute related to knowledge of~     how soon and how intense patients ventilated for more than 48 hours can endure mobilization.~     To evaluate the connections between functional ability and life expectancy for critically ill~     patients are compared to a population matching in age.~      This intervention project has a multicenter design with pre- and post research related to~     effect in early systematic mobilization of critically ill patients. 200 patients are included~     in the project.~      Data are collected at tests showing the functional ability of patients in different ways. The~     tests are made at the discharge from the Intensive Care Unit and 5 days after at their wards~     and again at 3 and 12 month from discharge when the patients have returned to their home. The~     project started in February 2011 and is expected to end in May 2013, findings is expected in~     November 2013.~   "
154057|NCT01549795|"~     Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be~     subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.~      Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent~     in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of developing~     this type of neoplasm. Only a minority of patients are suitable for resection partly because~     of the anatomic position of the tumor (which often arises from the bile duct bifurcation) and~     partly because of the frequently coexisting liver disease. In fact, CC is currently~     considered a major contraindication to liver transplantation (OLT) at the majority of~     centers, given a 5-year survival rate of 0%-35%.~      New strategies have been developed for the treatment of this kind of cancer arising in PSC.~     The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a~     neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver~     transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver~     transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5~     years survival. More convincing results come from the Mayo Clinic. An accurate selection of~     patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy and~     intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver~     transplantation.~   "
154058|NCT01549782|"~     Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium. Rectal~     biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface~     epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal~     inflammation. Modifications in intestinal microbiota, such as an increase in the number of~     pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is~     assessed by its capacity to stimulate the proliferation of healthy bacteria (Bifidobacterium,~     Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli).~      The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could~     modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients~     affected of gynaecological cancer and treated with abdominal radiotherapy.~   "
154059|NCT01549769|"~     This study is to evaluate the pharmacokinetics and pharmacodynamics of bardoxolone methyl in~     patients with chronic kidney disease and type 2 diabetes.~   "
154060|NCT01549756|"~     Find A Cure Panel is looking for people with Stage 4 stomach/gastric cancer or the caregivers~     of people with Stage 4 stomach/gastric cancer to participate in anonymous and qualitative~     research that will take an estimated 60 minutes of your time.~      This is opinion based, experiential research and is NOT a drug trial.~      Note that Stage IV is also known as advance disease or metastatic stomach/gastric cancer.~      If you are interested in participating, please email FACP at: info@findacurepanel.com~   "
154061|NCT01549743|"~     This clinical trial aims to assess the pharmacokinetic interaction between celecoxib and~     rebamipide in healthy male subjects.~   "
154062|NCT01549730|"~     The purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix cancer~     using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have~     an effect on how cervix cancer grows and responds to treatments like radiotherapy and~     chemotherapy. Doctors at Princess Margaret Hospital have measured hypoxia in over 300~     patients. The use of PET scans to measure hypoxia may be better and simpler than the methods~     used previously.~   "
154063|NCT01549717|"~     The investigators plan to study patients who have had cardiac surgery. Current standard~     practice is to monitor patients who have had cardiac surgery using wall-mounted monitors~     whilst they are on the Overnight Intensive Recovery (OIR) and the cardiac High Dependency~     Unit (HDU). The wall-mounted monitors monitor the vital signs continuously and alert the~     nurses if any abnormalities are detected. Once a patient is transferred from HDU to the~     cardiac surgery ward for the most part they are no longer connected to a continuous monitor.~     Instead, the majority of patients on the ward have their vital signs only intermittently~     checked during the day, using a spot check monitor. There is a small minority, chosen on~     clinical grounds, who are assessed with wireless telemetry monitors for a day or two.~      In this study the investigators will continuously monitor the vital signs of all enrolled~     patients from the time that they leave the operating theatre to the the time they are~     discharged from hospital. Whilst they are on OIR and HDU they will be monitored with the~     standard wall-mounted monitors in the normal fashion. When they then move to the ward the~     investigators will give all enrolled patients a telemetry monitor to wear as well as asking~     the nurses to check their vital signs with spot check monitors.~      The investigators will also collect information about the patients' general state of health~     and record indicators of worsening in patients' condition so that the investigators can~     determine how changes in the vital signs relate to deterioration. Finally the investigators~     plan to survey the patients and nurses to understand their experiences of continuous~     monitoring and what needs to be changed to improve the patient experience.~   "
154064|NCT01549704|"~     The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior~     to placebo when it comes to analgetic efficacy in high pain responders after Total Knee~     Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during~     knee flexion the 1. or 2. day after surgery.~   "
155100|NCT01536145|"~     This study represents the first-in-human study for CP-751,871. The study aimed to define the~     safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple~     myeloma through a dose escalation design.~   "
154067|NCT01549665|"~     Graft-versus-host-disease (GVHD) is a major complication following allogeneic hematopoietic~     stem cell transplantation (allo-HSCT) which may cause acute life-threatening morbidity or~     chronic disabilities. Although corticosteroid, the primary agent to treat GVHD, may be~     effective for some patients, outcomes of those who are refractory to corticosteroid are~     dismal. Secondary agents can be used for steroid-refractory cases; however, their efficacy is~     variable and usually limited. The quality of life issue of chronic GVHD is especially~     important for pediatric survivors who have longer life expectancy than adults. Many in-vitro~     and in-vivo data support immunoregulatory properties of mesenchymal stem cells(MSCs)and~     possibilities of treating diseases caused by immune dysregulation such as GVHD. Recent data~     revealed that bone marrow-derived MSCs were very useful to treat steroid-refractory acute~     GVHD, which led to improved overall survival compared with controls. More recently, a number~     of reports suggest MSCs may also be useful in treating chronic GVHD as well as acute GVHD. It~     has been also reported that third party MSCs are also useful as well as those from autologous~     or HLA-matched donors. The investigator recently demonstrated that MSCs obtained from~     umbilical cord blood (UCB) have similar immunosuppressive properties as bone marrow-MSCs.~     UCB-MSCs can be obtained without doing any harm to donors that it may be more appropriate~     source of MSCs than bone marrow for off-the-shelf use. However, little is known about the~     safety and efficacy of UCB-MSCs in treating GVHD. Therefore, the investigator designed this~     study to evaluate the safety and efficacy of UCB-MSCs in treating pediatric patients with~     steroid-refractory acute or chronic GVHD.~   "
154068|NCT01549652|"~     Opioid medications are commonly used for pain relief. When given over time, physical~     dependence can occur. This results in unpleasant side effects--such as agitation and~     nausea--if opioid medications are suddenly stopped. This study aims to test the use of the~     drug ondansetron to reduce the symptoms associated with opioid withdrawal and to prevent the~     progression of opioid physical dependence, thereby allowing future investigators to better~     test the role of physical dependence in the development of addiction and also possibly~     improving acceptance of abstinence-based programs for addiction.~   "
154069|NCT01549639|"~     Propofol is a commonly used agent for sedation and anaesthesia in the intensive care unit and~     the operating room. The pharmacokinetics of propofol are difficult to predict in patients not~     conforming to the norms in which the original pharmacokinetic research was based. Such~     patients, including the critically ill, and morbidly obese, are increasingly being~     encountered. The investigators group have been involved in the development of a device which~     can measure blood propofol concentrations, and hope for this to be available to use in the~     operating room in a clinically useful timeframe in the future. Data will be collected on~     patients undergoing propofol based general anaesthesia. The Marsh target controlled algorithm~     in effect site mode (commonly used by anaesthetists) will be assessed for accuracy using the~     propofol monitor. A new proportional correction method will be developed using this data,~     designed to enable recalibration of the TCI algorithm in near real time in order to achieve a~     more accurate estimated propofol concentration in these identified patient groups. The~     research will investigate the effectiveness of a correction of estimated propofol levels~     based on a one off measurement early on in the anaesthetic, and will take subsequent samples~     to measure propofol levels without modifying the TCI algorithm. Additionally, data on~     anaesthetist choice of TCI model, and method of administration in this relatively unselected~     group of patients will be analysed.~   "
154070|NCT01549626|"~     Inclusion of foods rich in fiber, such as flaxseed, is a nutritional strategy for treating~     obesity. The hypothesis of this study is to compare the effects of three types of flaxseed~     flour - whole brown flaxseed flour, brown defatted flaxseed flour and golden flaxseed flour~     in the sensations of appetite and satiety, lipid profile, pressure levels and associated~     costs in overweight and obese women.~   "
154071|NCT01549613|"~     This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the~     Emergency Department (ED) treatment of complicated skin and skin structure infection in the~     Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who~     are admitted to the RDTC cellulitis protocol in the ED will be randomized to either~     vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or~     daptomycin, which is the experimental treatment in this study. The primary hypothesis is that~     daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.~   "
154072|NCT01549600|"~     The Purpose of this study is to compare the effects of 2 types of dietary fiber, psyllium and~     microcrystalline cellulose (MCC), on glycemic measures in subjects with impaired fasting~     glucose.~   "
154073|NCT01549587|"~     This study will track changes in oral health in pregnant women. Subjects will be assigned to~     either regular oral care or advanced oral care and be given oral care products to use until~     they deliver. A comparison between the two groups (regular and advanced oral care) will be~     made to see if the oral care products impacted oral health and maternity variables.~   "
154074|NCT01549574|"~     This is an open-label, randomized, cross-over, single dose study in healthy volunteers to~     evaluate the potential effect of esomeprazole, a proton pump inhibitor, on the~     pharmacokinetics of crizotinib. Each subject enrolled will receive two single oral doses of~     crioztinib with or without esomeprazole separated by a washout period of at least 14 days.~   "
154075|NCT01549561|"~     The primary goal of this study is to test the efficacy of two levels of the KEEP intervention~     with adolescents and their foster and kin parents in the San Diego Child Welfare System.~   "
154076|NCT01549548|"~     The main purpose of this protocol is to provide expanded access to the study drug~     (Ponatinib/AP24534) for people with imatinib-, dasatinib-, and nilotinib-~     resistant/intolerant Philadelphia Chromosome Positive (Ph+) Leukemias. The other purpose of~     this protocol is to monitor the safety of the study drug in people with Ph+ Leukemias that~     have not responded to prior treatment.~   "
154091|NCT01549353|"~     Gum chewing has been reported to stimulate bowel motility after open surgery, such as~     cesarean section and other abdominal surgeries. In general, after laparoscopic surgery~     problems with reduced bowel motility are not as common as after open surgery. In this study~     the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel~     motility after gynecologic laparoscopic surgery. Further the investigators study patient~     satisfaction and potential side effects of postoperative gum chewing.~   "
190262|NCT01074073|"~     The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and~     Lurasidone HCl.~   "
154077|NCT01549535|"~     The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light~     source and other ancillary equipment. The system is intended for endoscopic diagnosis,~     treatment and video observation of the digestive tract. The PeerScope system model B is~     indicated for use for endoscopy and endoscopic treatment within the lower digestive tract~     (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.~      Objective:To compare the additional diagnostic yield obtained by using the PeerScope System™~     extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.~      In addition, time measurements including time to cecum, time for withdrawal and overall~     procedure time will be analyzed and reported for each group.~   "
154078|NCT01549522|"~     This is opinion based, experiential research and is NOT a drug trial.~   "
154079|NCT01549509|"~     The RV 156A clinical trial is evaluating an experimental HIV vaccine in people who are not~     infected with HIV. Participants in that study are randomly assigned to receive either the HIV~     vaccine or placebo. This study will enroll people who are participating in the RV 156 study.~     In this study, researchers will evaluate the safety of and immune response to a different~     experimental HIV vaccine in people who participated in the RV 156 study.~   "
154080|NCT01549496|"~     The purpose of this study is to evaluate the pharmacokinetic interactions between the~     hepatitis C NS3 protease inhibitor boceprevir and the calcium channel blockers amlodipine and~     diltiazem in healthy volunteers.~   "
154081|NCT01549483|"~     The purpose of this study is to study differences in small airways (<2mm) parameters in~     asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.~   "
154082|NCT01549470|"~     Currently, no vaccine prevents HIV infection. This study will test the safety and immune~     responses of an HIV-1 DNA vaccine in HIV-uninfected adults in a Ugandan population.~   "
154083|NCT01549457|"~     This study will examine the impact of use of mobile phones and text messaging on adherence to~     treatment for patients with latent TB infection. Half (50%) of the 350 anticipated study~     participants will receive weekly text messages inquiring on their health status in relation~     to their prescribed treatment, while the other half (50%) will not receive weekly text~     messages at all. Medical adherence will be assessed by monthly blood-work, clinic visits and~     by interviewing patients at each of these visits.~      The investigators hypothesis is that enhanced communication with a health care provider, via~     a structured cell phone SMS text messaging based program (WelTel), will result in a 15%~     improvement in the proportion of patients who successfully complete their LTBI treatment~     regimens.~   "
154084|NCT01549444|"~     The purpose of this study is to find out if mothers with high blood pressure (Hypertension)~     and/or diabetes have babies with high levels of different substances (that help to regulate~     blood pressure, called Renin and Aldosterone) in their blood. The investigators are also~     trying to determine if these babies have higher blood pressure than those babies born to~     mothers without high blood pressure or diabetes, during the first year of life.~      The investigators will measure your baby's blood pressure once a day for the first 4 days, at~     1 week of age, and then once per week until your baby is discharged. The investigators will~     also measure the blood pressure after discharge at 4 and 10 months of age, either on the day~     of your baby's follow-up appointment in the Neonatal Follow-up Clinic or at a visit to our~     Outpatient Nephrology Clinic, both at CHEO.~   "
154085|NCT01549431|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     panobinostat and carfilzomib have on the patient's cancer. It will determine the side effects~     of different dose levels of panobinostat and carfilzomib and determine the best dose and~     schedule of the two drugs to recommend for future studies. The study will assess the effects~     of the drug on multiple myeloma. In addition, tests to study the way the drugs work will also~     be done.~      The combination of the 2 drug classes have shown both pre-clinical (studies done in the lab)~     and clinical (studies done with people) effects against multiple myeloma. For this reason,~     these 2 drugs are being studied in combination to determine the side effects and anti-myeloma~     effects of the 2 drugs.~   "
154086|NCT01549418|"~     The risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin~     is uncertain. This is a randomized, multi-center, placebo-controlled, double-blind study to~     compare the risk of significant bleeding after endoscopic polypectomy of large (>=10mm)~     colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid (ASA)~     use. Eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg daily~     ASA or placebo 7 days before and 14 days following polypectomy. The primary endpoint of the~     study is bleeding within 30 days from colorectal polypectomy. The secondary endpoints are~     composite cardiovascular events occurring between the date of randomization and 30 days after~     polypectomy.~   "
154087|NCT01549405|"~     Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of~     patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy~     tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib~     level would alleviate postoperative pain and reduce analgesic consumption.~   "
154088|NCT01549392|"~     This study aims to assess the effect of Avastin on brain vascularity and blood-brain~     permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications~     have documented the method by which DECT can determine alterations in vascular volume and~     tissue permeability within tumors and normal brain tissue. Functional maps of cerebral blood~     flow cerebral blood volume and permeability-surface area can be generated from the DECT~     studies to assess tumor perfusion. MRI spectroscopy analyzes brain chemistry to detect tumour~     versus edema versus normal brain. Thirty patients will receive MRI spectroscopy and DECT~     imaging at the time of presumed recurrence and 3 months later. 15 patients who do not receive~     Avastin and 15 patients who do receive Avastin as standard treatment for recurrence will be~     studied with DECT and MRI spectroscopy at baseline and then again in 3 months.~   "
154089|NCT01549379|"~     For patients undergoing treatment for head and neck cancer, this study will use dynamic~     contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer~     and require surgical removal.~   "
154090|NCT01549366|"~     The purpose of this clinical investigation is to evaluate the Aspen™ device compared to~     pedicle screw instrumentation for posterior fixation in the treatment of patients with~     degenerative disc disease and/or spondylolisthesis. The Aspen™ device will be compared to~     pedicle screw instrumentation in Oswestry Disability Index (ODI) improvement and success of~     fusion.~   "
154093|NCT01549327|"~     For individuals diagnosed with colorectal cancer, exposure to up-to-date cancer information~     and support as well as guidance to access the most appropriate health care services is~     crucial for cancer self-management and support. Timely access to high quality cancer~     information is suggested to contribute to patient empowerment - defined as the perception of~     being better able to manage illness demands. With the advent of the information age,~     individuals are increasingly turning to online health information resources. The use of~     rigorous web-based tools is found to be an engaging and convenient way to access health~     information, while being tailored to people's needs and preferences. The present study seeks~     to examine the effects of a recently developed high quality and person-centred web-based~     tool, the Oncology Interactive Navigator (OIN) on patients' empowerment as well as document~     its cost-effectiveness. Participants newly diagnosed with colorectal cancer will be randomly~     assigned to experimental or control groups with the former having unrestricted access to the~     OIN for 8 months. Participants in the control group will receive care as usual. Information~     on background, medical characteristics, and empowerment will be collected as well as~     cost-effectiveness indicators. If producing the desired effects, the OIN could be proposed~     for national implementation across Canadian cancer centers. Work is currently underway to add~     over 23 types of cancer diagnosis to the OIN.~   "
154094|NCT01549314|"~     The purpose of this study is to determine whether ivacaftor, a recently FDA-approved CFTR~     potentiator, improves bone micro-architecture and strength in patients with cystic fibrosis~     with at least one G551D CFTR mutation.~   "
154095|NCT01549301|"~     The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects~     of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or~     intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects~     through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of~     serum levels of G-CSF and absolute neutrophil count - ANC).~   "
154096|NCT01549288|"~     Infantile spasms comprise an infantile epileptic encephalopathy characterized by~     hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the~     treatment of this disorder remains difficult. The first-line options which include hormonal~     therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and vigabatrin are~     effective in 60-70% of the patients. Hormonal therapy is considered the best available~     treatment. Vigabatrin being expensive and of limited availability is not a feasible option~     for most patients in our setting. Also, these are however associated with significant side~     effects, and high relapse rates. Newer drugs such as topiramate, zonisamide, and~     levetiracetam have also been evaluated; however these drugs are less effective than ACTH. The~     ketogenic diet (KD) is a high fat, low carbohydrate diet. It has been used for treatment of~     intractable childhood epilepsy. The KD has also been shown to be effective for intractable~     infantile spasms; often after ACTH and vigabatrin have failed.~      The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy~     that was designed to be a less restrictive alternative to the traditional ketogenic diet.~     This diet is started on an outpatient basis without a fast, allows unlimited protein and fat,~     and does not restrict calories or fluids. Preliminary data have shown efficacy in refractory~     infantile spasms. This diet is also ideal for resource-constraint settings with paucity of~     trained dieticians. Hence this study has been planned to evaluate the efficacy and~     tolerability of the modified Atkins diet in children with infantile spasms refractory to~     hormonal treatment in a randomized controlled trial.~   "
154097|NCT01549275|"~     The purposes of this prospective study were to evaluate the successful rate of primary~     culture of hepatocellular carcinoma cells and cancer-associated fibroblasts from the residual~     specimens in routine fine-needle aspiration of hepatic tumor and the potential application of~     this method as an additional tool for personalized treatment of hepatocellular carcinoma~     patients.~   "
154098|NCT01549262|"~     The purpose of this study is to determine whether the multivariable model for embryo~     selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by~     a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison~     with standard incubator and an embryo selection process based exclusively in morphology.~   "
154099|NCT01549249|"~     The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM)~     surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.~   "
154100|NCT01549236|"~     The purpose of this study is to describe the population pharmacokinetics parameters of~     benznidazole in children with acute or early chronic indeterminate form of Chagas Disease.~   "
154101|NCT01549223|"~     The central objective of this study will be to evaluate a standardized, evidence-based~     regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean~     delivery~      The investigators primary hypothesis is that the proposed uterotonic drug regimen, when~     compared to conventional dosing regimen, during elective cesarean delivery will:~      1. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain~     satisfactory uterine tone.~      Secondary outcomes to be evaluated will be:~        1. Reduce the side effects associated with uterotonic drug use~        2. Reduce the time to establishment and maintenance of adequate uterine tone~   "
154102|NCT01549210|"~     The study aims to identify which characteristics are associated with disability and poor~     quality of life in patients suffering from gout. This is a multicentre prospective~     observational study carried out in a cohort of Italian patients with gout. Subjects are~     randomly selected from a list of patients referred to each participant rheumatology clinic in~     the previous 2 years. Clinical evaluations are performed at baseline, at 6 and 12 months;~     data are retrieved about sociodemographic variables, life-styles, history of gout,~     comorbidities and patterns of treatment. At each visit patients complete questionnaires~     assessing disability and health-related quality of life. Preplanned analyses will be~     performed to investigate predictors of disability and poor quality of life in these patients.~   "
154103|NCT01549197|"~     The purpose of the study is to evaluate the quality of the dying process in french ICUs~     (assessed by the CAESAR scale) and to compare physicians', nurses' and relatives perceptions~     and experiences, with a one-year follow-up of bereaved relatives.~      Our hypothesis is that perception of the quality of dying may impact on relatives' experience~     of bereavement (anxiety, depression, complicated grief, posttraumatic stress disorder~     (PTSD)).~   "
154104|NCT01549184|"~     Retrospective study of the safety and efficacy of hydroxychloroquine among patients with~     immune Thrombopenia (ITP).~   "
154106|NCT01549158|"~     This is a randomized, open-label, blinded-endpoint, crossover, single dose study to compare~     the pharmacodynamics of Torasemide-PR 10 mg, Torasemide-IR10 mg and furosemide-IR 40 mg. 30~     patients of both sexes with CHF with a maximum imbalance of 60:40% in either direction will~     be included in the study. Patients with compensated heart failure, grade II or III as defined~     by the European Society of Cardiology, with a duration of ≥ 3 months at the time of inclusion~     documented in the patient's record or patients who previously required diuretic therapy.~      Principal variable will be the efficiency of sodium excretion that will be assessed as the~     ratio between the average drug-induced natriuresis and the average drug recovered in urine~     over 24 hours.~      The difference between the efficiency of 24 hour sodium excretion following administration of~     torasemide PR and furosemide will be formally tested by means of a Students t-test for paired~     samples. The test will be two-sided at 5% significance level. Efficiency changes over time~     will also be assessed, however will not be subject to formal statistical testing.~   "
154107|NCT01549145|"~     The objectives of this study are to evaluate the safety and efficacy of applying electrical~     stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic~     stimulation regimen.~   "
154108|NCT01549132|"~     The investigators believe that oxygen saturation measurements in the retina may provide more~     information on how well the retina is working and may detect problems in the retina earlier~     than the fundus fluorescein angiography (FFA). This may be useful to an ophthalmologist so~     that they may identify abnormal areas of the retina and commence or change the treatment so~     that they may prevent irreversible blindness.~      Most patients with clinically significant macular oedema and/or ischaemic diabetic~     retinopathy could have either laser or Intravitreal Anti-VEGF injection treatment provided~     they are counseled about the risks. It is known the Anti-VEGF injections reduce oedema and it~     is believed that laser treatment of the retina in this condition improves the oxygen supply~     to the retina and sometimes reverses the damage. It will be useful to take pictures of these~     treated eyes using the Oxymap spectral retinal camera(s) to see whether the investigators can~     detect a change in the oxygen saturation in the retina before and after treatment using our~     oxygen saturation methods.~   "
154109|NCT01549119|"~     The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic~     vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with~     undetectable viral loads.~   "
154110|NCT01549106|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the~     effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.~   "
154111|NCT01549093|"~     The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are~     more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung~     Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is~     a more effective way.~   "
154112|NCT01549080|"~     The primary objectives of this study are to evaluate whether Yisui Shengxue Granules therapy~     can increase the hemoglobin level in peripheral blood and alleviate the symptoms, and at the~     same time, evaluate its safety in the treatment of Thalassemia with the syndrome of~     deficiency of liver-yin and kidney-yin, and asthenia of essence and blood.~   "
154113|NCT01549067|"~     Collect the real clinical background of advanced colorectal cancer c of China.~   "
154114|NCT01549054|"~     This is a study in healthy subjects. There are two parts to the study. In the first part of~     the study each subject will receive a single 10mg dose of each of the four formulations of~     E550. Based on the results from Part 1, an optimal formulation will be selected for further~     evaluation in Part 2.~   "
154115|NCT01549041|"~     The investigators propose to explore: 1. the acceptance by patients of once versus twice~     daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing~     with asenapine, and 3. the changes in psychopathology associated with these two dosing~     strategies, in 30 patients with schizophrenia or schizoaffective disorder.~      The investigators hypothesize that patient and staff acceptance will be better with once~     daily dosing and that improvements in psychopathology will be similar across once daily and~     twice daily dosing~   "
154116|NCT01549028|"~     Patients with chronic obstructive pulmonary disease (COPD) are at increased risk of~     osteoporosis and fractures. Osteoporosis, however, may be equally as disabling as COPD, and~     may impair respiratory function even further if the patient experiences vertebral~     compressions.~      In this study, we will survey the prevalence, correlations and effectiveness of intervention~     of osteoporosis in COPD patients.~   "
154117|NCT01549015|"~     This diagnostic study will be performed to investigate the performance of the urea cycle in~     healthy subjects, asymptomatic carriers of Urea Cycle Disorders (UCD) mutations and subjects~     with genetically proven urea cycle disorders. The ureagenesis rate will be measured by 13C~     incorporation assay, a method for in vivo measurement of urea cycle performance with stable~     isotopes.~   "
154118|NCT01549002|"~     Children can develop abscesses (a collection of pus under their skin) that require a~     physician to cut it open to let the pus drain out. This is a painful procedure. Most medical~     professionals will use numbing cream and inject numbing medicine into the skin, just like at~     the dentist, to help reduce the pain. While this helps minimize the pain of cutting the skin,~     it doesn't help the pain associated with draining out the pus.~      There are many strategies and medications available to physicians to help decrease the pain~     of this procedure. Most of the medications available to treat the pain require the placement~     of an intravenous (IV) catheter through the patient's skin, which itself is a painful~     procedure. In the investigators emergency department, many patients with abscesses that need~     a procedure to drain the pus receive a medicine called morphine through an IV.~      Some pain medicines, however, can be sprayed into a patient's nose, and have been shown to be~     helpful at reducing the pain of a broken bone or a burn. These medicines do not require the~     placement of an IV.~      The purpose of this research study is to determine whether a medicine called fentanyl, when~     sprayed into the nose of patients aged 4 to 18 years undergoing abscess drainage, is not~     worse than IV morphine in decreasing the pain of the procedure.~      After the risks and benefits of the study are explained to patients and their parents,~     written informed consent will be obtained. Written informed assent will be obtained for~     patients older than 8 years of age. Like the flipping of a coin, a computer program will~     decide randomly which half of the patients will receive fentanyl nose spray and which half~     will receive morphine by IV.~      The patients assigned to receive fentanyl nose spray will not have an IV placed. The patients~     assigned to receive morphine will have an IV placed. Both groups of patients will have the~     abscess drainage procedure done the same way. All patients will be videotaped in order to~     score their pain by a trained observer. This score is the main outcome (measurement) in the~     study.~   "
154119|NCT01548989|"~     The main objective of this study is to perform the linguistic validation of a new french~     questionnaire in a population of sexually active (or not) patients who have undergone surgery~     (or not) for stress urinary incontinence or genital prolapse.~   "
154121|NCT01548963|"~     It is known that acute stress of organism often leads to hyperglycemia even in nondiabetic~     patients. It is also known that pathophysiological mechanisms: enhanced gluconeogenesis,~     impaired insulin secretion and decreased insulin sensitivity due to anti-insulin effect of~     stress hormones and proinflammatory cytokines, or changes of glucose excretion and renal~     tubular resorption.~      Many studies proved the negative effects of hyperglycemia to different tissues and organs,~     e.g. hearth (increasing size of myocardial necrosis, reducing coronary collateral blood flow,~     exaggerating ischemia-reperfusion injury, impairing ischemic preconditioning), vascular~     (increased risk of thrombosis, endothelial dysfunction, activation of systemic inflammation~     with destabilization of atherosclerotic plaques), kidneys and its association with infectious~     complications.~      The first Leuven study (published in 2001) demonstrated that hyperglycemia in critical care~     patients significantly increases risk of organ complication and total mortality. Although the~     importance of postoperative tight glycemia control is now widely accepted, glycemia stability~     during cardiac surgery is often neglected. It is known that postoperative hyperglycemia has~     negative effects, but it is not known what effect has its peroperative elevation.~      Goal of this study is to demonstrate, whether full perioperative intensive glycemia control~     can reduce the incidence of postoperative morbidity even more than postoperative glycemia~     control only.~   "
154122|NCT01548950|"~     The purpose of this study is to test the hypothesis that treating PAH-CHD patients~     preoperatively with PAH drugs and keeping them on treatment for six months after surgery~     reduces the risk of immediate postoperative death and the risk of residual PAH at six months~     following operation to <10%.~   "
154123|NCT01548937|"~     This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20~     AD depressive); each evaluable subject involved in this study must fulfill all the inclusion~     and exclusion criteria according the subject grouping.~      Safety measurement will be evaluated by medical history, vital signs, physical examinations,~     laboratory examinations and collecting of adverse events.~      This study is expected to be completed in a period of 3 years.~   "
154124|NCT01548924|"~     The investigators plan to study the determination of the dose and the combination of~     antiangiogenic effect of dovitinib and cytotoxic activity of weekly paclitaxel in different~     types of malignant tumors.~   "
154125|NCT01548911|"~     This clinical trial studies the side effects of gemtuzumab ozogamicin and how well it works~     in treating patients with acute myeloid leukemia. Monoclonal antibodies, such as gemtuzumab~     ozogamicin, can block cancer growth in different ways. Some block the ability of cancer to~     grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them~   "
154126|NCT01548898|"~     Laser causes elimination and miniaturization of hair shafts that are the principal~     contributor to inflammation in Acne Keloidalis Nuchae (AKN).~   "
154127|NCT01548885|"~     The purpose of this study was to evaluate the performance of one investigational Bayer Blood~     Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring~     Systems from other companies. All meter BG results were compared with plasma results obtained~     with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five~     systems was evaluated across the glucose range of the BGMSs using capillary blood. All~     testing and lancing were performed by study staff and some blood samples were glycolyzed to~     lower the glucose levels.~   "
154128|NCT01548872|"~     The purpose of this study is to compare two different cardioplegia solutions effect on~     postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.~   "
154129|NCT01548859|"~     The purpose of this study is to compare two different anaesthetic agent effect on~     postoperative Troponin I levels in pediatric cardiac surgery~   "
154130|NCT01548846|"~     This is a study whose main objective is to evaluate prospectively the proportion of patients~     with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.~   "
154131|NCT01548833|"~     The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1®~     silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel~     daily disposable contact lenses.~   "
154132|NCT01548820|"~     On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients~   "
154133|NCT01548807|"~     This is a Phase 1 dose escalation study of an investigational agent, everolimus, given in~     combination with standard radiation therapy, in prostate cancers with a rising PSA following~     a prostatectomy. A maximum of 33 people will be enrolled on this study at the University of~     Pennsylvania. The primary objective of this study is to determine the acute and chronic~     toxicities and maximum tolerated dose of everolimus with concurrent radiation.~   "
154134|NCT01548794|"~     The purpose of this study is the investigation of whether adding lidocaine to hyperbaric~     bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter~     recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy~     procedures.~   "
154135|NCT01548781|"~     Disturbances in movement coordination are the least well understood but often the most~     debilitating with respect to functional recovery following stroke. These deficits in~     coordination are expressed in the form of abnormal muscle synergies and result in limited and~     stereotypic movement patterns that are functionally disabling. The result of these~     constraints in muscle synergies is an abnormal coupling between shoulder abduction and elbow~     flexion (i.e. the flexion synergy), which significantly reduces the reaching function of an~     individual with stroke when they lift up the weight of the impaired arm against gravity. The~     investigators previous neurotherapeutic research, supported by a NIDRR Field Initiated~     research grant, has shown that the abnormal synergy between shoulder abduction and elbow~     flexion can be significantly reduced thus increasing total reaching range of motion in~     individuals with severe stroke. The previous work established progressive abduction loading~     as a key element to the rehabilitation of reaching. Although individuals with severe stroke~     benefited from the investigators previous work, residual flexion synergy continued to hinder~     normal arm function in most participants with severe stroke. This study will utilize the~     ACT3D robot, developed as part of the investigators previous NIDRR project, to incorporate~     resistance to reaching while accounting for the known benefits of progressive abduction~     loading. The investigators propose to randomize forty participants with severe stroke into~     two closely related interventions. The groups will both practice reaching under abduction~     loading, however, the experimental group will also move against resistance while reaching.~     Rigorous and quantitative investigation of therapeutic elements such as resistance to~     reaching and progressive abduction loading is only possible with a device such as the ACT3D.~     the investigators will be able to standardize the delivery of each intervention using~     kinematic and kinetic parameters, which will allow for a clear identification of the~     therapeutic effect of resistance to reaching. the investigators hypothesize that resistance~     to reaching in combination with progressive abduction loading will further increase dynamic~     multi-joint strength, increase total reaching range of motion, and increase arm function thus~     enhancing actual amount of use of the arm, participation in life roles, and quality of life~     in individuals with severe stroke.~   "
154510|NCT01543867|"~     This study is conducted in Europe. The aim of this study is to evaluate safety during the~     long-term use of somatropin (Norditropin®) in children as well as efficacy on change in~     height. A subgroup of children small for their gestational age is included.~   "
154136|NCT01548768|"~     For aim 1, the proposed studies will be performed in 150 patients with RA and 25 subjects~     without RA (healthy volunteers) who will function as controls.~      For aim 2, 25 of the patients enrolled in aim 1 (who are in need for further treatment due to~     increased RA activity despite their current treatment) will be recruited to continue in the~     study for an additional 24 (+/- 2) weeks (or 6 months). These patient will receive a TNF~     inhibitor in addition to their current treatment in an open label protocol for increased~     disease activity and in the context of standard of care.~      The investigators hypothesize that anti-TNF agents in RA patients without heart disease will~     not adversely affect the heart (will not cause a detrimental change in heart structure or its~     function).~   "
154137|NCT01548755|"~     The purpose of this study is to study workload assessment of home monitoring based follow up~     for ICD or CRTD implanted patient.~   "
154138|NCT01548742|"~     Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in~     serious impairments in interpersonal, occupational and social functioning. Effective~     treatments are available for PTSD but they do not work for everyone. Alternative treatments~     are needed to help those veterans not helped by currently available treatments. Mindfulness~     Based Stress Reduction (MBSR) is a group based treatment focused on mindfulness meditation.~     MBSR has been found to be effective in helping people with problems with pain and anxiety.~     MBSR has not yet been studied in veterans with PTSD. The proposed study will compare MBSR~     with a standard psychotherapy treatment in veterans with PTSD. This research is relevant to~     Veterans' health because of the need to develop alternative treatments for veterans with PTSD~     who have not responded to currently available treatments.~   "
154139|NCT01548729|"~     Patients with end-stage cystic fibrosis (CF) and severe CF-related diabetes (CFRD) may~     benefit from combined lung-pancreatic islet transplantation. A recent case series showed that~     combined bilateral lung and pancreatic islet transplantation is a viable therapeutic option~     for patients with end-stage CF and CFRD. The use of different organs from a single donor may~     lead to reduced immunogenicity. As the prevalence of CFRD has increased dramatically with the~     improved life expectancy of patients with CF, islet transplantation should be considered at~     the end-stage CF. By restoring metabolic control, the investigators hypothesize that islet~     transplantation may improve the management of CF patients undergoing lung transplant and~     decrease the complication rate in the early postoperative period.~   "
154140|NCT01548716|"~     Hypothesis:~      25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than~     those in HD patients with itching~      25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and~     compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of~     patients complaining of itching.~   "
154141|NCT01548703|"~     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     BCI-838 and its metabolite BCI-632 in healthy male and female subjects.~   "
154142|NCT01548690|"~     This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute~     liver failure/acute liver injury (ALF/ALI) in regard to:~        -  safety and tolerability;~        -  metabolism of the compound to glutamine and phenylacetylglutamine (PAGN);~        -  its effect on circulating ammonia levels and neurological function in patients with and~          without impaired renal function after continuous infusion at different infusion rates.~      Subjects will receive up to 120 hours (5 days) of drug infusion, followed by a 30 day~     follow-up visit post infusion. It is anticipated that this early safety and tolerability~     study, with appropriate PK/PD data, will lead to a development program for the use of OCR-002~     in the treatment of hyperammonemia either due to ALF or possibly other liver conditions. The~     hypotheses are:~        -  Treatment with OCR-002 is safe and tolerable in patients with acute liver failure/acute~          liver injury due to acetaminophen overdose or drug-induced liver injury, autoimmune~          hepatitis, viral hepatitis or indeterminate etiologies.~        -  A dose of 10-20g/24h (0.42-.83g/h) will achieve steady state plasma concentrations~          within 6-12h with little additional accumulation in the ALI/ALF setting.~        -  Treatment with OCR-002 will reduce ammonia and improve neurological function in patients~          with acute liver failure/severe acute liver injury.~   "
154143|NCT01548677|"~     This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer~     (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating~     tumour cells (CTC) in peripheral blood.~      Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the~     observation arm.~   "
154144|NCT01548664|"~     The purpose of this study is to identify whether the utilization of the Nintendo Wii™ gaming~     system, as an adjunct to conventional outpatient rehabilitation therapy, influence outcomes~     of patients following total knee replacement (TKR). The investigators hypothesize that the~     Nintendo Wii™ gaming system has a positive influence in the outcomes of patients following~     TKR.~   "
154145|NCT01548651|"~     The purpose of the study is to examine the effect of saxagliptin, an anti-diabetes~     medication, on hepatic and myocardial fat content and monocyte inflammation in patients with~     Impaired Glucose Tolerance (IGT).~   "
154146|NCT01548638|"~     This is a preliminary open-label study to determine whether a medication called galantamine~     (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that~     smokers experience during a quit attempt.~   "
154147|NCT01548625|"~     Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular~     events associated with air pollutants. Reactive oxygen species (ROS) have been implicated as~     a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of~     the glutathione-s-transferases (GSTs) have been shown to participate in the antioxidant~     defenses to air pollutants. This study examined the dose effects of diesel exhaust exposure~     on the cardiovascular system in healthy middle-aged subjects.~      Participants: Six healthy 50-75 year-old male and female subjects with GSTM1 null genotype~     had 3 sequential exposures to the diesel exhausts at concentrations approximately 100 µg/m3,~     200 µg/m3, and 300 µg/m3 for 2 hours with a about 2 weeks of interval between exposures.~   "
154226|NCT01547598|"~     This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost~     ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination~     ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution~     0.004%) monotherapy.~   "
154148|NCT01548612|"~     In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain~     unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO~     is a gas with unique chemistry and influences the release of neurotransmitters, learning,~     memory and neurodevelopment. Recent studies that investigated the role of NO in patients with~     schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in~     schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO~     donor, will ameliorate schizophrenia symptoms.~   "
154149|NCT01548599|"~     This pilot study aims to determine whether an agricultural intervention will improve food~     security, prevent treatment failure, reduce co-morbidities, and decrease secondary HIV~     transmission risk among people living with HIV/AIDS. The intervention will include: a) a~     human-powered water pump and other required farm commodities, b) a micro-finance loan (~$75)~     to purchase the pump and agricultural implements, and c) education in sustainable farming~     practices.~   "
154150|NCT01548586|"~     Transcranial direct current stimulation (tDCS) is a non invasive, painless, harmless way to~     modulate cerebral cortex excitability. It was shown that anodal stimulation increases~     cortical excitability and the cathodal one decreases it (Nitsche and Paulus, 2000; Lang et~     al. 2004). To date, there is no data in the literature regarding the effect of tDCS on the~     corticodiaphragmatic pathways. This preliminary study aims to test and validate the~     modulating effect of tDCS on the excitability of the primary motor cortex dedicated to the~     hemi-diaphragms in a sample of healthy subjects, as a prelude to further large studies in~     patients with paretic hemi-diaphragms. Diaphragmatic motor evoked potentials will be assessed~     before and after applications of three different modalities of tDCS (anodal, cathodal and~     placebo).~   "
154151|NCT01548573|"~     This study is designed to decrease toxicity associated with prior tandem transplant protocols~     by reducing the intensity of induction, consolidation and maintenance therapy, while~     increasing event-free survival by adding bortezomib (Velcade®), thalidomide, gemcitabine and~     carmustine to the transplant regimens to down-regulate the rescue of myeloma cells by the~     micro-environment and to prevent DNA repair post high-dose alkylating agent therapy. By~     reducing drug resistance, it is hoped that 3-year event-free survival will be increased~     significantly when compared to Total Therapy II. Additionally, participants will have the~     option of providing biospecimens for a sub-study evaluating gene expression profiling at~     specific timepoints to better understand drug-resistance in myeloma, and to determine whether~     there are genes or gene products in the resistant population that can be targeted by novel~     therapies.~   "
154152|NCT01548560|"~     This is a study to determine the safety of dapivirine gel and dapvirine film for healthy,~     HIV-uninfected women aged 18-45 years using the product for 7 daily doses.~   "
154153|NCT01548547|"~     This study aims to compare the clinical efficacy of multimedia audiovisual training to hands~     on practice till perfect training for pediatric and emergency medicine residents'~     procedural skills. This initial study will explore the success rates on infant lumbar~     puncture and child intravenous access skills in post-graduate year one pediatric residents.~   "
154154|NCT01548534|"~     The aim of this study is to increase, by DHA-induced chemosensitization, the activity of~     anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a~     nutritional approach with marin-derived PolyUnsaturated Fatty Acids (PUFA).~   "
154155|NCT01548521|"~     Background: Prader-Willi syndrome (PWS) is a rare, complex multisystem genetic disorder~     arising from the lack of expression of paternally inherited imprinted genes on chromosome~     15q11-q13. The syndrome includes severe neonatal hypotonia with impaired suckling leading to~     failure to thrive in the most severe cases, subsequently followed by an early onset of morbid~     obesity with insatiable hunger, combined with other endocrine dysfunction probably due to~     hypothalamic dysfunction. The pathophysiological mechanism of the occurrence of the 2 main~     nutritional phases of PWS is unknown. A deficit in the oxytocin (OT)-producing neurons of the~     paraventricular nucleus in the brain of these patients has been reported. In addition of its~     well-known anorexigenic effect, OT is involved in establishing and maintaining social codes.~     Indeed, we have recently shown in a double blind placebo study, that OT administration to~     adult patients with PWS significantly decreased depressive mood tendencies and tantrums while~     increasing trust in others with some data on a trend to decrease appetite with higher~     satiety. Moreover in a PWS mouse model generated from a MAGEL2 KO gene a single OT injection~     at 5 hr of life prevent the early death observed in 50 % of the new born mice by recovering~     normal suckling. Interestingly this effect is no longer observed if OT injection takes place~     later. These data, OT deficit in PWS, good tolerance of OT and its effect after intranasal~     administration in adult patients with PWS and the recent striking data obtained in the MAGEL2~     mouse model, prompted us to evaluate the tolerance of a single administration of intranasal~     OT in PWS newborns and its possible effect on suckling and food intake. Nowadays the~     diagnosis of PWS is done during the first months of life in our country. At this age,~     children still present with poor suckling suggesting that OT may be still efficient. Moreover~     in adult patients with PWS we have shown that OT improves some typical behavioral troubles.~     Therefore we first want to evaluate the tolerance of the intranasal administration of OT in 6~     infants with PWS genetically confirmed and its effect on suckling, milk intake and weight~     gain.~   "
154156|NCT01548508|"~     The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation~     (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment~     could improve functional exercise capacity.~   "
154157|NCT01548495|"~     The purpose of this study is to verify the presents of autoantibodies in serums of MDS serum~     patients who had an inadequate response or did not respond to Recombinant human~     erythropoietin (rHuEPO) treatment.~   "
154158|NCT01548482|"~     This phase I trial studies the side effects and the best dose of trebananib and temsirolimus~     when given together in treating patients with solid tumors that are metastatic or cannot be~     removed by surgery. Trebananib may stop the growth of tumor cells by blocking blood flow to~     the tumor. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving trebananib with temsirolimus may be an effective treatment for~     solid tumors.~   "
154159|NCT01548469|"~     The hypothesis of this study is that using Bio Mineral toothpaste for 4 weeks will decrease~     plaque and gingivitis of mild periodontitis patients compared to patients using Perio Total~     Care toothpaste.~      This study is Single blind, Randomized, Active-controlled Comparative clinical trial to~     evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral~     toothpaste in patients with mild periodontitis.~   "
154240|NCT01547416|"~     The aim of this study was to investigate whether robot assisted laparoscopic radical~     prostatectomy give rise to the impairment of diaphragmatic function postoperatively, and~     whether combined general/epidural anesthesia could provide better postoperative diaphragmatic~     function.~   "
154160|NCT01548456|"~     This is a prospective observational study of patients with femur fractures in Dar es Salaam,~     Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open~     reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of~     reoperation for any reason, and the secondary outcomes are fracture healing, return to work,~     and health-related quality-of-life. The investigators hypothesize that there will be a~     difference in the rate of reoperation for patients with femur fractures treated with an IMN~     compared to ORIF with a plate.~   "
154161|NCT01548443|"~     The wound healing efficacy and safety of Medifoam H in patients with minor, acute trauma.~      The hypothesis of this study is that using Medifoam H dressing for a week is not inferior~     to using Duoderm THIN dressing in wound healing.~   "
154162|NCT01548430|"~     The purpose of the study is to examine the safety, tolerability, immunogenicity and~     pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive~     impairment.~   "
154163|NCT01548417|"~     The primary hypotheses under test are that alcohol dependent subjects treated with~     mifepristone will report decreased craving for alcohol following alcohol exposure in the~     laboratory and report significantly less drinking under naturalistic conditions, than those~     treated with placebo.~   "
154164|NCT01548404|"~     To assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668/SAR231893 in~     adult patients with moderate-to-severe atopic dermatitis (AD).~   "
154165|NCT01548391|"~     This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171~     in healthy male subjects.~   "
154166|NCT01548378|"~     The purpose of this study is to evaluate whether intramuscular injections of NL003 into the~     calf is safe and effective in the treatment of critical limb ischemia~   "
154167|NCT01548365|"~     The purpose of this study is to determine whether an infusion therapy nursing expert service~     is effective in decreasing hospital length of stay, improving the clinical results of venous~     access devices and increasing patient satisfaction with venous access.~   "
154168|NCT01548352|"~     Syncope is a major health problem. In the emergency department (ED), the management of~     patients with syncope still remains a clinical challenge because underlying diseases and~     prognosis can be extremely various. Structural heart disease and primary electrical disorders~     are major risk factors for sudden cardiac death and mortality in patients with syncope. In~     contrast, patients with reflex syncope and exclusion of structural heart disease have an~     excellent prognosis.~      Therefore The investigators test the hypothesis that the use of a meticulous patient history,~     clinical examination and novel biomarkers can improve the rapid and accurate diagnosis of~     cardiac syncope in patients presenting to the ED and is able to improve risk stratification~     regarding adverse outcomes.~      The prospective multicenter cohort study is designed to enroll 720 patients presenting with~     transient loss of consciousness within the last 12 hours to the ED. Blood samples for the~     measurement of novel biomarkers will be obtained at presentation.~      All patients will be contacted by phone at 6, 12 and 24 months to determine major adverse~     events (death, resuscitation, recurrence of syncope, hospitalization for syncope).~   "
154169|NCT01548339|"~     The purpose of this study is to compare the clinical outcomes of early versus delayed~     laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.~   "
154170|NCT01548326|"~     The purpose of this study is to determine whether short-term Atorvastatin can increase the~     immunity response to hepatitis B vaccination in vaccine Nonresponders.~   "
154171|NCT01548313|"~     The ideal food for normal infants is human milk. In addition, breast milk has been shown to~     be a continuous source of commensal, and⁄or probiotic bacteria to the infant gut where they~     play a key role in the initiation and development of the gut microbiota. Intestinal~     colonization is essential for maturation of the gut-associated lymphoid tissue (GALT) and the~     homeostasis of the intestinal epithelium. Colonization begins immediately after birth, while~     later the composition of the gut microbiota is affected by feeding practices. Results of some~     studies suggest that long-chain polyunsaturated fatty acids (LCPUFAs) promote the adhesion of~     probiotics to mucosal surfaces and along with probiotic bacteria contribute to the regulation~     of innate and adaptive immune responses and present a link among mother's diet, and microbes.~     The main purpose of the proposed research is to establish the link among mothers' nutrition,~     human milk LCPUFAs composition and microbiota and their potential influence on child's gut~     microbiota development. Pregnant women from three different regions of Slovenia will be~     involved into the study. Dietary intakes will be assessed during pregnancy, at the beginning~     of the 3rd trimester of pregnancy, and during lactation, at 4 weeks post partum, by 7-day~     weighed dietary protocol (7DP). Human milk (colostrum, and mature human milk) and infant's~     faeces will be sampled twice: at 2 or 3rd day post partum (meconium) and at 4 weeks post~     partum for the determination of human milk LCPUFAs composition and the assessment of human~     milk (colostrum und mature) and faeces microbiota. The fatty acid composition of human milk~     will be analysed by capillary gas-liquid chromatography (GC). Microbiota of milk and faeces~     will be studied using conventional microbiological and modern molecular approach such as~     qualitative and quantitative PCR amplification of informative genomic regions, DGGE/TGGE~     and/or t-RFLP and sequencing. Regular monthly meetings with the researchers will be organised~     for discussion and advising. Basic health parameters of infants will be followed. Data will~     be gathered from maternity department medical charts, from regular paediatric health care~     visits and from especially designed health care diary each mother will keep until the end of~     her child's first year.~   "
154172|NCT01548300|"~     The investigators posit that a multi-national collaborative effort with focused~     investigations in environments with the highest levels of exposure (developing countries such~     as China and India), are likely to provide new and much needed data on the risk posed by~     these variables on an individuals life-time risk for type 2 diabetes and cardiovascular~     complications. The investigators will test this hypothesis through the establishment of a~     network that would lead studies on the links between exposure and adverse Chronic~     cardiometabolic effects and propose doing this in this as part of 3 specific aims.~   "
154173|NCT01548287|"~     This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease~     or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is~     to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.~   "
154174|NCT01548274|"~     The purpose of this study is to evaluate the effects of Sarpogrelate in endothelial~     progenitor cells of patients with atherosclerosis.~   "
154203|NCT01547897|"~     Primary objective:~      - To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine~     ratio (ACR) in patients with type 2 diabetes and albuminuria~      Secondary objectives:~        -  To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c)~        -  To evaluate the effect of study drug on markers of glycemic disorders, systemic~          inflammation, renal and liver disease and cardiovascular function~        -  To assess the safety and tolerability of study drug~        -  To determine the population pharmacokinetics (PK) of study drug~   "
154175|NCT01548261|"~     Cultivated oral mucosal epithelial sheets on amniotic membrane have been reported to have~     good clinical results in treating patients with ocular surface disorders in both human and~     animal studies. However, such technique has not been well established in this hospital. The~     main purpose of this study is to obtain the discarded oral mucosal tissue from healthy donors~     who volunteer to donate their oral mucosa from buccal area. The obtained oral mucosal tissue~     will be cultured under different types (co-culture with or without 3T3 cells)。Inverted light~     microscopy, electron microscopy and immunostaining with K3/K12, K14, Ki67, P63, connexin 43,~     and involucrin will be preformed to test the effects of foreskin cell line co-culture system~     on cell condition. The investigators plan to start the study from Jan. 1st, 2011 to Dec.~     31th, 2015. Thirty patients will be enrolled.~   "
154176|NCT01548248|"~     This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety~     of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and~     incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes~     treated with insulin NPH under normal clinical practice conditions in Slovakia.~   "
154177|NCT01548235|"~     This study is conducted in Europe. The aim of this study is to investigate safety and~     efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin~     aspart 30 (NovoMix® 30) treatment.~   "
154178|NCT01548222|"~     This is a trial to determine if patients who are well controlled and on basal insulin are~     treated with excessive basal dose.~   "
154179|NCT01548209|"~     Postoperative nausea and vomiting (PONV) is common following beast surgery. Dexmedetomidine~     was reported to a reduced PONV due to opioid-sparing effect. It is not clear if~     dexmedetomidine itself is useful on reducing PONV. The hypothesis of present study:~     intraoperative application of single dose dexmedetomidine (0.5 mcg/kg) is is effective than~     placebo for reducing of PONV and improve postoperative quality of recovery score within 48~     postoperative hours.~   "
154180|NCT01548196|"~     The purpose of the study is to assess and compare the efficacy and morbidity standard~     percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be~     enrolled. Patients will be randomized to one of four groups: standard percutaneous~     nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or~     ureteral stent/catheter. Primary Outcome Measures will include length of procedure and~     estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores,~     time to ambulation, time to oral intake, and pain scores will also be recorded. Time to~     nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge~     from the hospital will also be recorded. Incidence and type of post-operative complications~     will also be recorded.~   "
154181|NCT01548183|"~     The US preventative services task force (USPSTF) recommends behavioral counseling in the~     primary care setting for prevention of sexually transmitted diseases, however, screening and~     counseling rarely occur. Text messaging (TM) is increasingly being used as a tool to affect~     behavior change in patients, but its effect on patients that report at-risk sexual behavior~     in the emergency department (ED) is unknown. The investigators seek to assess the feasibility~     of ED-based screening of young adult females for at-risk sexual behavior and enrolling them~     in a 3 month trial using TM to deliver information and skill building to improve health~     behavior.~   "
154182|NCT01548170|"~     Sunitinib is an ATP competitive tyrosine kinase inhibitor of several membrane receptors~     including VEGFR-1, -2, and -3, PDGFR-α and -β, c-KIT, CSF-1R, FLT-3, and RET. Through this~     molecular mode of action, sunitinib is able to avoid tumoral angiogenesis and proliferation.~     Sunitinib is already approved by the FDA, EMEA and AEMPS for the treatment of patients with~     metastatic renal cell carcinomas and those with metastatic gastrointestinal stromal tumors~     (GIST) with progression or intolerance to imatinib.~      Suntinib has recently reported to be superior than placebo in terms of response rate (9.3%~     vs. 0%; p<0.05), progression free survival (11.4 vs. 5,5 months; HR 0.41;p<0.05), and overall~     survival (HR 0.40;p<0.05) when administered in a phase 3 trial to patients with advanced~     pancreatic neuroendocrine tumors (NETs).~      Sunitinib is an expensive drug that drains the budget of health public system therefore it~     demands a rational drug use.~      Sunitinib is metabolized by CYP3A4, that belongs to the P450 cytochrome system in the liver.~     Most of the drug is eliminated in faeces and only 16% by urine. Sunitinib has no food-effect~     when taken with meals. Pharmacokinetics parameters did not differ between cancer patients and~     healthy volunteers.~      Houk et al. Showed that the area under the curve of plasmatic concentration of sunitinib and~     its active metabolite did correlate with clinical outcome. In other words, the higher plasma~     concentration area under the curve the highest rates of radiological response, progression~     free and overall survival rates.~      Ketoconazol is an antifungal drug that inhibits the CY3A4 inducing an elevation of peak~     plasma levels of other drugs administered simultaneously and that are metabolized by the same~     system. In the labeling sheet of sunitinib it is said that ketoconazol induced a 49% and 51%~     of increase of plasmatic sunitinib Cmax y AUC0-∞ when both drugs were administered together.~     This fact makes that the investigatorspropose that by administering both drugs simultaneously~     the investigators could reduce sunitinib dose by a lower metabolization with similar plasma~     concentration. The dose reduction would impact in drug cost.~      Here the investigators propose to determine the most optimal combination dose of sunitinib~     (25 mg or 37.5 mg) and ketoconazol (200mg o 400mg) by which the investigators could have~     plasmatic bioequivalent concentrations compared with single dose of sunitinib 50mg.~      Each volunteer will be assigned to a treatment arm (Arm A and Arm B). Volunteers included in~     Arm A will take: sunitinib 50 mg, sunitinib 37.5 mg + ketoconazole 200 mg and sunitinib 37.5~     mg + 400 mg ketoconazole. Volunteers included in Arm B will take: sunitinib 50 mg, sunitinib~     25 mg + ketoconazole 200 mg and sunitinib 25 mg + 400 mg ketoconazole~   "
154183|NCT01548157|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of HCP1007 capsules and Rosuvastatin plus Omega-3.~   "
154184|NCT01548144|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed)~     or of the combination of 3 study drugs that can be given to patients with advanced cancer.~     The safety of these drug combinations will also be studied.~      Crizotinib is designed to block a protein called ALK, which is involved in cancer cell growth~     and survival.~      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for~     tumor growth. This may prevent or slow the growth of cancer cells.~      Pemetrexed is designed to block proteins that may cause tumors to grow.~      This is an investigational study. Crizotinib is FDA approved and commercially available for~     the treatment of locally advanced or metastatic non-small cell lung cancer. Pazopanib is FDA~     approved and commercially available for treatment of advanced renal cell carcinoma.~     Pemetrexed is FDA approved and commercially available for the treatment of non-small cell~     lung cancer.~      The combination of crizotinib with pazopanib, crizotinib with pemetrexed, pazopanib with~     pemetrexed, and giving all 3 drugs together to patients with advanced cancer is~     investigational.~      Up to 364 patients will take part in this study. All will be enrolled at MD Anderson.~   "
154185|NCT01548131|"~     Site of research: Helsinki University Central Hospital (HUCH), Department of Obstetrics and~     Gynaecology and University of Helsinki Department of Psychology, in collaboration with~     Karolinska University Hospital in Stockholm, Sweden~      In Finland and in Sweden, fear of childbirth is one of the most common reasons for~     consultation of obstetrician, and for an elective caesarean section. Approximately 5 to 6% of~     pregnant women suffer from severe fear of childbirth, which disturbs family-life and working~     and prevents the preparation to normal childbirth and parenthood. It represents as~     nightmares, panic attacks, anxiety, and as numerous physical complaints. After giving birth~     it can be difficult for these women to form an early mother-infant-relationship. Their risk~     for puerperal depression is also increased.~      Finland and Sweden have both a long tradition in research of this field. In Finland, the~     investigators research group started the first out-patient clinic for fearful pregnant women~     in HUCH in1996. Different strategies how to treat fear of childbirth have been applied to~     clinical practise. Studies on the treatment for fear of childbirth are, however, scanty. Some~     descriptive studies have showed that far more than one half of patients can, after the~     treatment, prepare to a normal vaginal delivery and caesarean without a medical indication~     can be avoided. The aim of the treatment should be both to avoid unnecessary caesareans,~     increase the number of uneventful vaginal deliveries and to help the pregnant couple to~     prepare to parenthood, as well as to prevent puerperal depression.~      In this study, psychotherapeutic group psychoeducation is studied as promising treatment for~     severe fear of childbirth. To screen fear of childbirth, all women coming to ultrasound~     screening at the 18 to 20 gestational week in HUCH are asked to fill in a specific~     questionnaire. Those nulliparous women whose score for fear exceeds 95th percentile are~     randomized to intervention and to control group.~      The intervention group is invited to start a psychotherapeutic group therapy based on~     cognitive and psychodynamic therapy combined with training in relaxation. Each group consists~     of six nulliparous women and meets six times during pregnancy 120 minutes at a time. Between~     the sessions the patients fill in a homework questionnaire. One session focuses on the~     partner's role and the partners are present then. Three months after delivery, the groups~     meet once more.~      The women in the control group stay in the care of community midwives and general physicians.~     If needed, they are referred to out-patient clinic in the maternity hospital where their fear~     is treated according the clinical practice of that hospital, mainly support from obstetrician~     or midwife.~      The women and their partners in both groups are asked, approximately one month after the~     screening and one month before the due date of delivery, to fill in the questionnaires~     examining depression, self-esteem, general anxiety, social support, marital satisfaction,~     personal projects and concerns, and efficacy concerning childbirth and maternity. After~     childbirth, data about the childbirth will be collected. Three months and two years after~     childbirth mothers and fathers in both groups receive again a psychosocial questionnaires.~      The aim of the study is to help the authorities to organize the treatment for fear of~     childbirth in their districts by examining the benefits of the treatment also in long-run.~     The investigators hope the results would lead to production of Current Care guidelines for~     fear of childbirth.~   "
154186|NCT01548118|"~     This study will evaluate the safety of a novel recombinant human papillomavirus bivalent (~     types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years~     of age at enrollment.~   "
154189|NCT01548079|"~     In an open-label trial, 20 otherwise healthy morbidly obese patients scheduled for bariatric~     surgery will be administered 20 mg/kg/day ursodeoxycholic acid for three weeks until the day~     before surgery. The maximum dose will be 3 g/day. Twenty other patients will serve as~     controls. Serum from days 1 and 21 will be analyzed for routine liver tests, bile acids, a~     complete lipid profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and~     fibroblast growth factor 19 (FGF-19), markers for bile acid synthesis its intestinal~     stimulation. For the evaluation of insulin resistance and possible pre-diabetes, plasma will~     be taken for the estimation of homeostasis model assessment (HOMA) index and oral glucose~     tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy (0.5-1~     g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately frozen in~     liquid nitrogen for messenger ribonucleic acid (mRNA) and protein preparation for~     quantitative real-time polymerase chain reaction (RT-PCR) and Western analysis, respectively,~     histopathological Non-alcoholic fatty liver disease (NAFLD) grading, and measuring of hepatic~     and white adipose tissue (WAT) lipase activity. In all patients at randomization, abdominal~     ultrasound will be performed for the detection of NAFLD and gallstones and a blood sample~     will be taken for the analysis of polymorphisms of hepatic lipid synthesis, storage, fatty~     acid (FA) oxidation and export genes. Six month after operation, HOMA, OGTT and abdominal~     ultrasound will be repeated.~   "
154190|NCT01548066|"~     Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and~     regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at~     low level through regulation by GSK-3, multifunctional serine/threonin kinase. After~     phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore,~     inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce~     growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for~     decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been~     studied yet.~   "
154191|NCT01548053|"~     Alzheimer's disease (AD) and related forms of dementia currently affect over 400,000~     individuals in Canada and the numbers of community dwelling older adults with AD is rapidly~     growing. AD is associated with over $15 billion annually in care costs. Most individuals with~     AD are under the care of primary care providers (PCPs) including family physicians and~     primary care nurses. The evaluation and management of AD is challenging for PCPs and the~     quality of care provided to older adults with AD by PCP could be improved which would~     optimize outcomes for this vulnerable population. Provision of quality care to older adults~     with AD involves implementation of best practices as outlined in guidelines such as the~     Canadian Consensus Conference Guidelines on the Diagnosis and Treatment of Dementia.~     Utilizing a group of dementia researchers, PCPs, other knowledge users, and individuals~     affected by AD, this project will develop practical, clinically relevant resources for~     primary care physicians and nurses to aid in the evaluation of older adults with AD. A~     knowledge tool, the Primary Care - Dementia Assessment and Treatment Algorithm (DATA Tool)~     will be introduced into several primary care settings in Ontario using educational sessions~     with PCP with additional support from internet resource and a dementia care manager. The~     quality of dementia care provided to older adults newly diagnosed with AD will be assessed in~     the three years preceding the intervention compared to the year following the implementation.~     This project will also describe the process of knowledge exchange with PCPs, including~     potential barriers and facilitators of knowledge uptake and examine if the care provided~     during the intervention was patient-centred through interviews with patients and caregivers.~      Research Objectives:~        1. Develop knowledge tools to facilitate assessment and treatment of AD by PCPs based on~          best evidence;~        2. Transfer these knowledge tools into a variety of primary care settings in Ontario; and,~        3. Evaluate the effects of this intervention on dementia quality of care, PCP application~          of knowledge, and the patient-centeredness of care.~   "
154192|NCT01548040|"~     The study is a prospective, randomized, double-blind sham study of TKA patients who receive a~     standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative~     treatment program plus a sham device.~   "
154193|NCT01548027|"~     The objective of this study to determine the effect of surgical transversus abdominis plane~     block and local infiltration for postoperative pain control in major abdominal surgery~     compare with control group.~   "
154194|NCT01548014|"~     The purpose was to evaluate as to whether administration of infliximab of 12 week interval~     with supplementary VSL#3 is more effective or at least of similar efficacy when compared to~     conventional administration of infliximab only of 8 week interval.~   "
154195|NCT01548001|"~     This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod~     in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid~     Arthritis (RA).~   "
154196|NCT01547988|"~     The purpose of this study was to evaluate the effect of a group-based functional and specific~     balance training program on balance function in healthy older adults. It is commonly~     considered difficult to improve balance function in healthy older adults. The program~     included dual-task exercises; physical training exercises and a cognitive task (e.g. reading~     or reciting a story) performed simultaneously, as well as perturbation exercises, where~     balance is challenged in unexpected ways.~      The investigators hypothesized that following the proposed training, older adults would~     improve their speed of taking a step in both single and dual task conditions, refine their~     ability to control balance when standing still and improve their self-reported physical~     function.~   "
154197|NCT01547975|"~     Currently, no demographic and surgical results comparing different donor cornea sources were~     available in Taiwan. National Taiwan University Hospital (NTUH), as one of the largest~     tertiary medical centers in northern Taiwan, is now in charge of a big part of intense care~     for patients receiving corneal transplantation. With detailed medical record done of these~     patients during care in the ward and out-patient clinic, the investigators are competence for~     this meaningful program.~   "
154198|NCT01547962|"~     The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a~     free autogenous graft using donor tissue harvested from the subject's palate in the treatment~     of subjects who have an insufficient zone of attached gingiva associated with at least two~     non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment~     and control in the change in amount of attached gingiva over the 6 month observation period.~      Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft~     will be placed in the other. The grafts will be evaluated clinically to determine the change~     in the amount of attached gingiva and on at least three subjects, a small biopsy will be~     taken to allow histologic evaluation and comparison of both grafts.~   "
154199|NCT01547949|"~     The purpose of this study is to assess the effects of tart cherry juice to reduce serum~     biomarkers of inflammation and reduce muscle soreness in healthy adults who undergo a bout of~     controlled eccentric exercise.~   "
154200|NCT01547936|"~     The purpose of this study is to evaluate the effect of the controlled adverse environment~     (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.~   "
154204|NCT01547884|"~     Background:~      - Lymphatic filariasis is an infection that is caused by small, thread-like worms. It is~     spread by mosquitoes, and causes fever, chills, and headaches. If untreated, it can also~     cause elephantiasis, a condition that leads to swelling of the arms, legs, breasts, and~     scrotum. Treatment can eliminate the worms from the blood and reduce the risk of developing~     elephantiasis. Researchers want to study people with latent tuberculosis (TB) who may or may~     not be infected with filariasis. This study will look at the way that people with latent TB~     fight infection with these worms.~      Objectives:~      - To study how the immune systems of people with latent TB react to filarial infection.~      Eligibility:~      - Individuals between 18 and 65 years of age who have latent TB and may or may not have~     filarial infection.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide a blood and stool sample to test for infection.~        -  Participants who do not have lymphatic filariasis but have another kind of intestinal~          worm will be treated for the parasite. This will be their last study visit.~        -  Participants who have latent TB and lymphatic filariasis will be treated with the~          standard treatment for the disease. They will come back for a second visit 6 months~          later, and will provide another blood sample.~   "
154205|NCT01547871|"~     Background:~      - Spinal muscular atrophy type 1 (SMA 1) causes severe muscle weakness and problems with~     eating and breathing. The symptoms begin in infancy, and children affected with SMA 1 often~     die in early childhood. Researchers want to collect information on how SMA symptoms progress~     in first two years.~      Objectives:~      - To study how the symptoms of SMA 1 progress in infants and children.~      Eligibility:~      - Infants and children with SMA 1 born on or after January 1, 2007.~      Design:~        -  Researchers will review the child s medical records and talk with parents by telephone.~        -  For children who are under 2 years of age, the researchers will review the child s~          medical records and speak with you on telephone every 2-4 months. Phone calls with~          parents will take about 10 minutes and will involve questions about symptoms of SMA 1.~          Children will be followed until age 2.- Researchers are also interested in looking at~          medical records of children who are no longer alive or who are more than 2 years of age.~      Parents or children do not have to come to the NIH. They will provide consent to view these~     records, and information over the telephone.~      - No treatment or care will be provided as part of this study.~   "
154206|NCT01547858|"~     Background:~      - Formaldehyde has many uses in industry and medicine. However, exposure to formaldehyde has~     been associated with increased risk for myeloid leukemia. There are still questions about how~     the chemical reacts with bone marrow to increase this cancer risk. Some smaller studies have~     looked at how it affects stem cells, which are found in bone marrow. Researchers want to~     develop a much larger study of workers in China. The study will look at different levels of~     formaldehyde exposure. It will focus on how the chemical affects the blood cells and bone~     marrow.~      Objectives:~      - To study the effects of formaldehyde exposure on blood cells and bone marrow.~      Eligibility:~      - Individuals between 18 and 60 years of age who work in selected factories in Guangdong~     Province, China.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          be screened with a work history. Those who have been exposed to benzene, butadiene,~          styrene, or radiation will not be included.~        -  Participants will be studied based on their regular formaldehyde exposure level.~          One-third will be those exposed to more than 1 part per million (ppm) of the chemical.~          One-third will be those exposed to 0.3 to 1 ppm. A control group will have no exposure~          to formaldehyde or any other known toxic chemical.~        -  Participants will provide blood and cheek swab samples. They will also answer questions~          about their work habits.~        -  To look at chemical exposure levels, participants will wear a small monitor to work on 3~          different days. They may provide additional blood and cell samples as directed.~        -  No treatment will be provided as part of this study.~   "
154207|NCT01547845|"~     Background:~      - Cancer and cancer treatments can cause symptoms and side effects. Pain, fatigue, and~     emotional distress are three common symptoms. Accurate reporting of these symptoms can~     improve treatment methods and outcomes. Even though symptom reporting is important to~     treatment, there is no method to collect and compare patient data from multiple cancer care~     centers. Researchers want to develop a method for collecting cancer patient symptom~     information from multiple centers. This method may help improve cancer treatment at hospitals~     and other care centers.~      Objectives:~      - To collect patient-reported symptom information from multiple cancer care centers.~      Eligibility:~        -  Individuals at least 21 years of age who were treated for breast or colon cancer in the~          past year.~        -  Participants will come from one of the participating cancer care centers.~      Design:~        -  Participants will answer a short questionnaire about their symptoms during cancer~          treatment. Questions will ask about symptom severity and experiences. Other questions~          will ask how well the doctors and nurses managed the symptoms.~        -  Participant responses will be compared with other medical and personal information. This~          information may include cancer type, age at diagnosis, and type of treatment.~        -  Treatment will not be provided as part of this study.~   "
154208|NCT01547832|"~     Background:~      - Early-onset Parkinson's disease (EOPD) is more likely to be caused by gene mutations than~     Parkinson's disease that develops in older people. Studying these mutations may help find~     therapies for EOPD. Researchers want to study mutations on a gene called PARK2. These~     mutations prevent fat uptake into cells and may interfere with normal brain function.~     Researchers want to study fat and cholesterol in the body to look at the effects of these~     mutations on the body and brain.~      Objectives:~      - To study connections between genetic mutations and EOPD.~      Eligibility:~        -  Individuals between 18 and 80 years of age with EOPD.~        -  Individuals between 18 and 80 years of age with no family history of Parkinson s~          disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected.~        -  Participants will have some or all of the following tests:~        -  Blood samples and tissue (skin and fat) biopsies~        -  Cell line development from these tissue samples to study the function of PARK2~        -  DEXA scan to measure body fat context using low dose x-rays~        -  Glucose and insulin tolerance testing to measure blood sugar levels.~        -  Treatment will not be provided as part of this protocol.~   "
165376|NCT01401075|"~     Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus,~     aVQ) in patients with gastric cancer receiving oral chemotherapy.~   "
154209|NCT01547819|"~     Background:~      - Some people who have a traumatic brain injury (TBI) recover completely. Others, however,~     develop post-traumatic stress disorder (PTSD), with anxiety and depression. Research suggests~     that levels of a brain chemical called GABA may differ in people with PTSD compared to those~     without PTSD. Researchers want to see if TBI can affect GABA in the brain and help develop~     PTSD. To look at the brain, researchers will use imaging studies with the chemical~     11C-Flumazenil, which will help the scan show GABA levels in the brain.~      Objectives:~      - To study the relationship between PTSD and TBI.~      Eligibility:~      The subjects will be recruited from the Walter Reed National Military Medical Center~     (WRNMMC).~        -  Individuals between 18 and 50 years of age who have PTSD and/or had a mild TBI.~        -  Healthy individuals between 18 and 50 years of age who have no history TBI and no~          history of PTSD.~      Design:~        -  Participants will be screened with a physical exam and medical history. Urine and breath~          samples will also be collected.~        -  Participants will have two imaging studies, on the same day if possible. The first will~          be a magnetic resonance imaging scan to look at the brain. The second will be a positron~          emission tomography scan with the study chemical to look at GABA pathways in the~          brain....~   "
154210|NCT01547806|"~     Background:~      - One beneficial treatment for plasma cell myeloma is high-dose chemotherapy followed by stem~     cell transplant. Researchers want to collect stem cells from the blood for later transplant.~      Objectives:~      - To collect stem cells for transplant as part of treatment for plasma cell myeloma.~      Eligibility:~      - Individuals at least 18 years of age who will have chemotherapy and stem cell transplant~     for plasma cell myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have filgrastim injections for 5 days before collection. This will~          move stem cells from the bone marrow to the blood.~        -  Participants will have apheresis to collect the stem cells.~        -  Participants who need additional apheresis procedures to collect stem cells will have~          filgrastim and a dose of plerixafor to improve the collection yield.~   "
154211|NCT01547793|"~     Background:~      - Some people with sickle cell disease have different health problems than others. This may~     be related to how easily and frequently the red blood cells break apart in the blood.~     Researchers want to test breath and blood samples from people with sickle cell disease to~     look for very small amounts of carbon monoxide, which is produced when red blood cells break~     apart. They will compare these results with breath samples from healthy volunteers. Studying~     different levels of carbon monoxide may help predict what health problems a person with~     sickle cell disease may get. It may also provide more information on possible treatments.~      Objectives:~      - To study breath carbon monoxide levels and their possible relation to the severity of~     sickle cell disease.~      Eligibility:~        -  Individuals at least 18 years of age with sickle cell disease.~        -  Healthy volunteers who are matched for age, sex, and race with the sickle cell disease~          group.~      Design:~        -  Participants will be screened with a medical history.~        -  Participants with sickle cell disease will provide a blood sample and have a heart~          function test. They will also breathe into a bag to provide an exhaled breath sample.~        -  Healthy volunteers will provide an exhaled breath sample.~        -  No treatment or care will be provided as part of this study.~   "
154212|NCT01547780|"~     Background:~      - People with traumatic brain injury (TBI) often have inflammation in the brain. A protein~     called the translocator protein (TSPO) is often present with inflammation. Researchers want~     to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and~     inflammation in the brain of people with TBI.~      Objectives:~      - To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic~     brain injury.~      Eligibility:~        -  Individuals at least 18 years of age who have had TBI and have had a brain scan that~          shows signs of inflammation.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  All participants will have two brain scans during an outpatient visit. A magnetic~          resonance imaging scan will study brain activity. A positron emission tomography (PET)~          scan will use [11C]PBR28 to look for signs of TSPO and brain inflammation.~        -  Participants with TBI will have two PET scans within 10 days of the head injury, and a~          PET scan around 90 days after the injury. They may also have MRI scans under this or~          another study. Tests of thinking, memory, and concentration will be used to study the~          effects of the injury and inflammation~   "
154213|NCT01547767|"~     Background:~      - A mutation in a gene known as ISCU was found to be the cause of a rare myopathy that~     affects the muscles. Researchers collected clinical samples from people with this myopathy.~     More research is being done to develop a therapy for this disease. Researchers are asking for~     permission to study the samples already collected.~      Objectives:~      - To allow researchers to use clinical samples collected to study new treatments for ISCU~     myopathy.~      Eligibility:~      - People with ISCU myopathy who have provided clinical samples for study.~      Design:~        -  Participants will allow researchers to study clinical samples already collected. Blood,~          urine, muscle, and cell samples may be used. Medical records and photographs may also be~          studied.~        -  Treatment will not be provided as part of this study.~   "
154225|NCT01547611|"~     Many patients with cervical disc disease have long-lasting and complex symptoms with chronic~     pain, low levels of physical and psychological function and sick-leave. Surgery on a few~     segmental levels might be expected to solve the disc-specific pain but not the non-specific~     neck pain and the patients'illness. As much as 2/3 of the patients have been reported to have~     remaining physical/ psychological disability long-term after surgery. A structured~     physiotherapy programme after surgery may improve patients'function and return to work. The~     main purpose of the study is to evaluate what a well structured rehabilitation program adds~     to the customary treatment after surgery for radiculopathy due to cervical disc disease in~     respect to function, disability, workability and cost effectiveness. The study is a~     prospective randomised controlled multi-centre study, with an independent and blinded~     investigator comparing two alternatives of rehabilitation. 200 patients in working age, with~     cervical disc disease with clinical findings and symptoms of cervical nerve root compression~     will be included after informed consent. After inclusion in the study patients will be~     randomised to one out of the two alternatives of physiotherapy, (A) customary treatment~     (information/ advice on the specialist clinic) or (A+B) active physiotherapy; standardised~     and structured program of neck specific exercises combined with a behavioural approach plus~     customary treatment. Patients will be evaluated both clinically and with questionnaires~     before surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery. Main~     outcome variable are neck specific disability. Cost-effectiveness will be calculated. The~     inclusion will preliminary be closed 2012. The study could contribute to a better clinical~     decision making, a better health care which will reduce physical, mental and social costs for~     the patients, and improve the rates of patients returning to and staying at work.~   "
154214|NCT01547754|"~     Background:~      - Some people with human immunodeficiency virus (HIV) develop problems with thinking and~     concentration when the virus affects the brain. This is known as mild neurocognitive disorder~     (MND). Research has shown that some HIV medications do not get through the blood brain~     barrier very well. P-glycoprotein (P-gp) is a brain protein that is part of the blood brain~     barrier. Differences in the activity of P-gp may help explain why some people with HIV~     develop MND. It is also possible that MND is partly due to inflammation in the brain.~     Researchers want to study P-gp and its effect on MND and HIV infection.~      Objectives:~      - To study P-gp and brain inflammation related to HIV infection.~      Eligibility:~        -  Individuals between 18 and 60 years of age who have HIV and either do or do not have~          MND.~        -  Healthy volunteers between 18 and 60 years of age.~      Design:~        -  Participants will be screened with a medical history and physical exam. Blood and urine~          samples will be collected.~        -  Participants will have one outpatient visit and one 3-day inpatient stay.~        -  At the outpatient visit, participants will provide blood samples and have a lumbar~          puncture (spinal tap). The spinal tap will collect cerebrospinal fluid for study.~        -  At the inpatient visit, participants will have two positron emission tomography (PET)~          scans of the brain. These scans will study brain activity and possible inflammation. One~          scan will involve a study drug called tariquidar, which blocks the activity of P-gp. A~          second lumbar puncture will be done before the first PET scan. Blood and urine samples~          will be collected daily.~   "
154215|NCT01547741|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast~     cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs~     in different combinations may kill more breast cancer cells. Giving combination chemotherapy~     after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This randomized phase III trial is studying different combination chemotherapy~     regimens and their side effects and comparing how well they work in treating women with~     non-metastatic breast cancer.~   "
154216|NCT01547728|"~     The objective of this study is to prospectively evaluate the response of recombinant~     antithrombin (rAT) (ATRYN) in patients who are heparin resistant and are scheduled to undergo~     cardiac surgery.~   "
154217|NCT01547715|"~     This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal~     ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.~   "
154218|NCT01547702|"~     The purpose of this study is to evaluate, by way of randomized controlled trial, the~     effectiveness of a web-based, time-flexible, and teacher-directed Teacher Help for ADHD~     program in reducing the impact of ADHD symptoms in elementary students.~   "
154219|NCT01547689|"~     The primary purpose of this study is to evaluate the safety and the tolerability of UC-MSC~     (Human Umbilical Cord-Derived Mesenchymal Stem Cell) .This study is also to investigate the~     efficacy of this treatment in patients with Alzheimer's disease (AD).~   "
154220|NCT01547676|"~     This randomized pilot trial studies clamped or unclamped surgery in treating patients with~     kidney cancer. Unclamped surgery for kidney cancer may have fewer side effects~   "
154221|NCT01547663|"~     This study aims to test validity, reliability and practicality of translated NCS, CNPI and~     FLACC in unconscious patients in 48 hour following craniotomy.~   "
154222|NCT01547650|"~     Rossi NF & Schrier RW reported that for having differential diagnosis in hyponatremic state,~     it is important to have a grasp of extra cellular fluid (ECF) volume. However, recent works~     showed that it is not easy to estimate the ECF state using by physical findings and by usual~     laboratory methods.~      Damaraju SC et al. first demonstrated that measuring central venous pressure (CVP) is~     significant to evaluate the ECF state in hyponatremic patients with intracranial diseases.~     Accordingly, it may be useful to measure the CVP in the hyponatremic patients. However,~     usually it is difficult to measure the CVP in all patients with hyponatremia because that the~     method is due to invasive procedure. With recently development, it is possible to estimate~     the CVP calculation using cardiac echogram without invasion. However, it is not clear that an~     evaluation by using such echogram estimates the state of ECF volume in hyponatremic patients.~      Therefore, the investigators examine whether the CVP calculation by using cardiac echogram by~     Marcelino P et al. method without invasion is estimated such condition in hyponatremic~     patients before and after treatments.~      As the primary endpoint, the VCI index values is investigated and compared with each group~     before and after correction of disorders of fluid with sodium. Furthermore, some variables~     including sodium, potassium, chloride, creatinine, BUN, uric acid, osmolality in blood and~     urine and plasma vasopressin are investigated and compared with each group before and after~     correction of disorders of fluid with sodium.~   "
154223|NCT01547637|"~     The key objective of this study is to compare success rates of ultrasound guided obturator~     nerve block and anatomic landmark guided obturator nerve block as determined by~     neuromonitoring endpoints and surgeon observations.~   "
154224|NCT01547624|"~     Today there is evidence for that neck specific exercises reduce neck pain problems in~     patients with mechanical neck pain. However, there is a lack of consensus on how to optimize~     neck exercises and dosages in neck rehabilitation. More knowledge is needed to determine~     which and how muscles are activated in exercises thought to be neck-specific. There is~     neither enough knowledge of differences in neck muscle activation between patients with long~     standing neck problems after a whiplash trauma and healthy controls nor if the neck muscle~     function improved with specific neck exercises. One approach would be a real time study of~     deformation and deformation rate in different layers of neck muscles in patients with~     residual long-term neck pain and disability after a whiplash trauma. The purpose of the~     present study was to investigate deformation and deformation rate in different layers of~     dorsal and ventral neck muscles (including upper and middle part of trapezius muscle) during~     rest and during different exercises; arm flexion until 120 degrees, repeated arm flexion~     until 90 degrees, low loaded neck extension, low loaded neck muscle endurance test, shoulder~     elevation. Forty patients with long standing (more than 6 months but less than 3~     years)patients and 40 controls matched for age and gender will be included for comparisons~     between patients and healthy in neck muscle activation. The investigators also include 60~     patients with whiplash trauma, of those 30 patients will be randomized to A. neck specific~     exercises in a 3 months period and B. will 30 be on a waiting list for 3 months. Measurements~     are performed at baseline and at 3 months follow-up. Those patients who fulfilled the 3~     months period of neck specific exercises will also be asked for a 6 months follow-up.~   "
154227|NCT01547585|"~     This study is being conducted to test the hypothesis that daily consumption of a baked food~     product containing whole soy for 6 weeks will significantly reduce plasma Low Density~     Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the overall~     goals of this study are to determine whether daily consumption of muffins made from whole soy~     flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect~     is dose-dependent. To do this, study collaborators will: (1) conduct a detailed chemical and~     physical characterization of certified defatted whole soy flour that will be incorporated~     into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a~     control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy~     muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical~     trial. All participants will be randomized into one of three groups and asked to eat two~     muffins daily for 6 weeks in the following combination: high dose soy; control group or low~     dose soy. Before, after, and mid-way during the feeding period, blood samples will be~     obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals.~     The effect of soy consumption on waist circumference, body mass index (BMI) and blood~     pressure will also be examined.~   "
154228|NCT01547572|"~     Since the introduction and favourable early results of enhanced recovery programmes more than~     a decade ago, such programmes have become increasingly popular following major surgery. Many~     elements of these programmes are based on solid evidence and derived from published trials.~     These programmes optimize different factors to reduce the stress of surgery with the aim of~     improving patient outcome and speed up recovery after surgery. Key factors prior to surgery~     are conditioning of expectations and optimizing associated disease. Strategies during the~     operation include use of short-acting anaesthetic (sleeping) agents, maintenance of normal~     temperatures and minimal access surgery (keyhole surgery).~      Care after surgery is optimized with appropriate analgesia (pain killers), early mobilisation~     (walking) and early feeding. This combined approach reduces hospital stay to 2-4 days. There~     is also evidence that the improvements resulting from the implementation of an enhanced~     recovery programme do not cause significant deterioration in quality of life or transfer~     costs to another component of health care.~      The relative contribution of each of the single elements in the enhanced recovery programme~     remains uncertain. Good patient information gives confidence and improves overall outcome. No~     studies have examined the impact of video education on recovery.~      The aim of this study is to explore the use of video information provision for patients~     participating in an enhanced recovery programme.~   "
154229|NCT01547559|"~     We aim to evaluate the protective effects of eradication of HP and continue using~     Geranylgeranylacetone (GGA) on NSAIDs related gastroenterological lesions. We further aim to~     explore the effect of GGA on small-intestinal mucosal injuries induced by diclofenac sodium~     in patients with rheumatic diseases who didn't take NSAIDs in the preceding 6 months.~   "
154230|NCT01547546|"~     This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and~     tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with~     progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the study.~     Stage 2, patients will receive GDC-0084 at a recommended dose for future studies.~   "
154231|NCT01547533|"~     The investigators propose to study the transfer of benznidazole into breastmilk from the~     blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk~     and blood samples will be obtained from these patients at given times after they take the~     clinically indicated medication, and the concentrations in both matrices will be compared to~     estimate degree of transfer, which in turn will be used to evaluate potential degree of~     exposure of infants breastfed by these women. This study will help clarify safety of~     continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.~   "
154232|NCT01547520|"~     Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and~     analgesic effects, so its use may be helpful for patients receiving upper endoscopy.~   "
154233|NCT01547507|"~     The aim of this prospective, randomized study is to compare the performance, safety, and ease~     of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System~     and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26 adults~     with an endotracheal tube and mechanical ventilation will be randomized into 2 groups to~     receive one of the following closed suction systems endotracheal tubes:~        1. AirWay Medix Closed Suction System~        2. KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared~          regarding the safety, performance and ease of use (usability).~   "
154234|NCT01547494|"~     The purpose of the study is to assess whether, in individuals with migraines, a low-fat,~     vegan diet improves pain more effectively than a control supplement or a placebo. The~     principal measures are pain as measured by Visual Analog Scale (VAS) and the change in~     migraines frequency. The study duration is 36 weeks.~   "
154235|NCT01547481|"~     This proposal is focused on developing a reliable, valid, and reproducible imaging techniques~     and statistical methodology for segregation of various forms of Parkinsonism from healthy~     adults without Parkinsonism.~   "
154236|NCT01547468|"~     The purpose of this study is compare the rates of post-operative delirium between a group of~     people receiving intravenous (IV) pain control after hip fracture surgery and a group of~     people receiving a femoral nerve catheter for pain control. Post-operative delirium is~     confusion that can happen after the deep sleep of anesthesia. AThe hypothesis is that the~     group receiving the femoral nerve catheter for pain may have a lower incidence of delirium~     than the group receiveing IV pain medication.~   "
154237|NCT01547455|"~     Statins were reported to have pleiotropic effects including antiinflammatory, anti-oxidative~     stress effects and stabilise plaque in some conditions. Some researches indicate loading dose~     statin can reduce contrast induced nephropathy, and the levels of inflammatory markers were~     significantly decreased. The investigators hypothesis loading dose atorvastatin may attenuate~     inflammatory response during cardiopulmonary bypass (CPB) and therefore reduce postoperative~     acute kidney injury in cardiac surgery.~   "
154238|NCT01547442|"~     The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia~     Lens in the treatment of aphakia in children.~   "
154239|NCT01547429|"~     This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used~     as a secondary implant to correct aphakia in adults.~   "
154241|NCT01547403|"~     The primary objective of the CUSTOM study is to respond to customer support issues (outside~     of the US) and to assess the impact of a particular treatment or perturbation relative to an~     initial control measurement. Sequential subject measurements will be analyzed to determine if~     a given action or condition induces a score shift, an inflation of measurement variance or~     elevated outlier rates.~   "
154242|NCT01547390|"~     This is a randomized controlled trial to estimate the efficacy of low dose aspirin for~     preventing preeclampsia in women identified as high risk. The investigators hypothesize that~     the risk of preeclampsia in women identified by a first trimester multiparameter predictive~     model to be at high risk will be significantly reduced by initiating low dose aspirin early~     in pregnancy.~   "
154243|NCT01547377|"~     The aim of this randomized double-blind study was to evaluate the effect of oral zinc and~     selenium supplementation on oxidative stress and inflammation biomarkers as well as the~     status of zinc and selenium in patients with atherosclerosis and angina stable treated with~     rosuvastatin. The hypotheses tested in this study were: Treatment with rosuvastatin impairs~     zinc and selenium status in patients with atherosclerosis and stable angina? Zinc and~     selenium supplementation, concomitantly with rosuvastatin, influences the antioxidant and~     anti-inflammatory as well as the status of minerals?~   "
154244|NCT01547364|"~     Objective: The purposes of the study are to~        1. Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in~          comparison to normal saline.~        2. Determine if cumulative benefit results from caudal dextrose injection.~        3. Evaluate accuracy of a small needle vertical approach caudal injection that will allow~          for blind injection of D5W.~   "
154245|NCT01547351|"~     This Phase 4 pilot cross-sectional descriptive/exploratory study is to be conducted in~     clinical practice settings (including MS (Multiple sclerosis) specialty clinics, general~     neurology practices, or other academic or private practice settings) in the United States to~     assess the psychometric properties of the ARMS questionnaire in approximately 100 adult~     patients with MS who are experiencing a confirmed relapse, as identified by the investigator~     or designee at each site. Neither efficacy nor safety of treatment will be evaluated in this~     study.~      The ARMS questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1~     page. Part 1 is designed to evaluate the patient's relapse symptoms and how the symptoms~     affect daily activities and overall function, as well as patient's response to past~     treatments for previous relapses, as a means of guiding treatment selection. Part 2 is~     designed to evaluate treatment response in terms of symptom relief and functioning, as well~     as treatment tolerability. Part 1 of the survey is to be completed when the patient presents~     with new relapse of MS. Part 2 of the survey is to be completed 1 month (± 1 week) after~     initiation of treatment for relapse of MS. Treatment for relapse will be at the sole~     discretion of the investigator.~   "
154246|NCT01547338|"~     Current qualitative methods of assessing the aesthetic result following breast reconstruction~     are known to be poor.~      The investigators believe that real time digital video footage followed by expert panel~     review would be a superior method of qualitative assessment of breast cancer reconstruction~     aesthetics. This has never been studied before.~   "
154247|NCT01547325|"~     The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo~     Hydrogel on Dehisced Surgical Wounds.~   "
154248|NCT01547312|"~     This study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA)~     as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of~     Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C~     virus (HCV). The first segment, is a procedural pilot conducted prior to the main study, that~     is aimed at ensuring optimal execution of the FNA procedure. During the procedural pilot,~     core needle biopsy (CNB) will be performed on participants as part of their standard of care,~     but no study drugs will be administered, nor will any procedures other than FNA be conducted.~     The second segment, the main study, is designed to evaluate the feasibility of measuring~     Grazoprevir by FNA. During the main study, drugs will be administered, and other additional~     procedures will be conducted.~   "
154249|NCT01547299|"~     The purpose of this study is to determine if enzalutamide is an effective therapy in treating~     localized prostate cancer prior to prostatectomy.~   "
154250|NCT01547286|"~     Asthma is a disease of rapidly increasing incidence that already affects more than 17 million~     people in the United States alone. It has long been known that areas of severely reduced~     airflow occur in asthma and contribute significantly to the impairment of gas exchange in~     this disease. However, the extent to which local blood flow changes during an asthmatic~     attack is unclear. The purpose of this study is using Positron Emission Tomography - Computed~     Tomography imaging to evaluate how the blood flow changes in the lungs during an asthma~     attack induced by allergens.~   "
154251|NCT01547273|"~     The purpose of this investigator-initiated study is to evaluate the facial gingival profile~     following immediate implant placement and provisionalization in conjunction with connective~     tissue graft with or without bone graft~   "
154252|NCT01547260|"~     The purpose of this study is to ascertain whether treatment with lenalidomide or lenalidomide~     in combination with gemcitabine induces modulation of immune effector functions and to~     characterize the nature of immune functions.~   "
154253|NCT01547247|"~     Water immersion insertion has been documented to decrease procedure-related discomfort during~     colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal~     intubation time. The investigators would like to assess whether combination of cap-fitted~     colonoscopy and water immersion insertion is feasible and safe method of diagnostic~     colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that~     the use of cap is able to shorten it significantly. Patient comfort during colonoscope~     insertion, water consumption, length of the scope while reaching the cecum, need for external~     compression, need for positioning of the patient and endoscopist´s difficulty with~     colonoscopy are assessed.~   "
154264|NCT01547104|"~     The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison~     to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism~     and oxidative stress in type 2 diabetic patients on stable control with metformin.~   "
154511|NCT01543854|"~     This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart~     failure. In addition safety and effects on renal function and biomarkers will be assessed.~   "
154254|NCT01547234|"~     Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young~     adults, with onset usually at age 20-40 years. Women are affected 3-4 times more than men.~     The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course.~      Several immunotherapies were developed in the last 10-15 years for the long term management~     of the relapsing type of disease. Treatment with these drugs decreases disease activity~     though cannot cure it.~      There are few treatments for targeting specific symptoms of MS, such as Provigil for the~     treatment of fatigue.~      Regarding problems related to spasticity and related gait problems , which is stated by over~     40 % of MS patients as their main complaint - present treatments include: non-pharmacological~     treatments such as physiotherapy, occupational therapy, hydrotherapy and pharmacological~     treatments such as Baclofen, Tizanidine and Botulinium toxin.~      Fampyra (Fampridine) has recently been approved for use in patients with gait problems. This~     drug acts by blocking potassium ion channels and has been proven to improve walking in 35% of~     the patients after one month of treatment.~      The effect of Fampyra on hand function in MS has yet to be studied. The aim of this research~     project is to assess the effect of treatment with Fampyra on manual function of patients with~     MS. The investigators hypothesize that through the same mechanism by which Fampyra improves~     ambulation it can also improve manual function.~      MS patients visiting the MS center clinic at the Carmel Medical Center, with walking~     disabilities eligible to Fampyra treatment, that have also manual dysfunction, will be~     offered to participate in this study. Participants who agree to participate will be asked to~     sign a written informed consent. Information regarding their personal and family medical~     history will be collected via questionnaires. Medical staff will fill clinical questionnaires~     detailing patient clinical status prior to the study.~      Patients will be followed up to 4 months after initiation of treatment with Fampyra.~     Compliance to treatment will be assessed by collection of the empty vials of the medication.~      In each of the follow-up meetings evaluation of manual function, evaluation of ambulation and~     evaluation of general neurological function will be performed.~   "
154255|NCT01547221|"~     Otomycosis is a superficial fungal infection of the external ear canal. Patients should be~     treated with cleaning fungal debris combined with topical antifungal agent. There is wide~     range of topical antifungal agents. However, there is still no consensus of the most~     effective topical antifungal agents in treatment otomycosis is still lacking.~      According to Thai National List of essential medicines for topical antifugal agents are:~        -  acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol)~        -  boric acid (3% in isopropyl alcohol)~        -  gentian violet~        -  clotrimazole ear drop. But from literature review, there is no comparative study between~          boric acid and clotrimazole solution before.~      Objective is to compare the clinical effectiveness and adverse events of 1% clotrimazole~     solution versus 3% boric acid in 70% alcohol for the treatment of otomycosis.~   "
154256|NCT01547208|"~     The purpose of this study is to assess whether the burden of untreated non-sustained~     ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates~     with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if~     the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.~   "
154257|NCT01547195|"~     The recent scientific evidence shows that FM patients improve exercise capacity, symptoms and~     quality of life with the holding of regular exercise, especially aerobic exercise. Swimming~     is an aerobic workout of low impact, but no study has evaluated the effect of this activity~     in patients with fibromyalgia.~      Randomized controlled trial with blinded evaluator, which will be evaluated patients with~     fibromyalgia were divided into two groups.~      The intervention group will hold an exercise program of swimming (freestyle) and the other~     considered the control group held a walking program.~   "
154258|NCT01547182|"~     The aim is to study the effects of weight loss and weight loss combined with different types~     of physical activity on changes in physical functioning of older adults who are at-risk for~     cardiovascular disease.~   "
154259|NCT01547169|"~     The study will examine the effects of intranasally administered long-acting insulin detemir~     on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment~     (aMCI). The rationale for these studies is derived from growing evidence that insulin~     contributes to multiple brain functions, and that insulin dysregulation can contribute to AD~     pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have~     beneficial effects on brain function. Intranasal administration of insulin increases insulin~     signaling in brain without raising peripheral levels and causing hypoglycemia. Insulin~     detemir is an insulin analogue that may have better action in brain than other insulin~     formulations because of its albumin binding properties. The investigators will test the~     therapeutic effects of intranasally-administered insulin detemir in a dose-finding study in~     which participants will receive one of two doses of insulin detemir or placebo for a three~     week period. The investigators will test the hypothesis that either dose will improve memory~     and daily functioning in persons with AD/aMCI compared with placebo.~   "
154260|NCT01547156|"~     Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of~     diabetes and hypertensive patients by introducing a remote patient monitoring system~     supported with automatic patient decision support. The feedback system is coupled with~     back-office health coaching.~   "
154261|NCT01547143|"~     The investigators would like to propose a pilot study evaluating the efficacy of etoposide~     combined with immunosuppressive agents for adult secondary hemophagocytic lymphohistiocytosis~     (HLH), in order to prove out whether the modification of previous HLH-94 or HLH-2004 protocol~     for childhood patients can improve the outcome and decrease the toxicities. The results of~     this pilot study will be a base of a more-improved phase-2 protocol.~   "
154262|NCT01547130|"~     A quality colonoscopy examination remains as the gold standard for colorectal cancer~     screening, but effective large bowel cleansing prior to colonoscopy is still not achieved in~     all cases that undergo the procedure. Currently, the most widely used cleansing methods~     employ balanced electrolyte-polyethylene glycol (PEG) solutions. However, a very large volume~     of PEG solution is required for it to be effective, and many patients refuse to drink a~     sufficient amount due to non-palatability. In this study, the investigators compare a novel~     colon preparation method--bolus lukewarm saline with yoga exercise--with a PEG based solution~     (HalfLytely) for large bowel cleansing.~   "
154263|NCT01547117|"~     Patients with POTS may not adequately expand their plasma volume in response to a high-sodium~     diet. Mechanisms involved in the regulation of plasma volume, such as the~     renin-angiotensin-aldosterone system and renal DA, may be impaired in POTS and may respond~     inappropriately to changes in dietary sodium.The purpose of this study is to determine (1)~     whether a high dietary sodium level appropriately expands plasma volume in POTS; (2) whether~     plasma renin activity and aldosterone are modified appropriately by changes in dietary sodium~     in POTS; and (3) whether patients with POTS have improvements in their orthostatic~     tachycardia and symptoms as a result of a high dietary sodium level.~   "
154564|NCT01543165|"~     This study is to see whether the combination regimen of ketorolac and nefopam is superior to~     that of ketorolac and morphine in controlling ureter stone-related acute flank pain.~   "
154265|NCT01547091|"~     Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic~     inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the~     destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis~     is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects~     and thus potentially alleviates the progression of rheumatoid arthritis. The study is to~     explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid~     arthritis.~   "
154266|NCT01547078|"~     A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in~     patients with liver disease.~   "
154267|NCT01547065|"~     The investigators hypothesize that transesophageal echocardiography is a valid method to~     obtain renal doppler hemodynamics2, 4. The goal of this study is to determine if there is a~     correlation between abnormal TEE resistive index measurements, intraoperative events and~     post-operative creatinine changes~   "
154268|NCT01547052|"~     I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children~     (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60~     children in the comparison condition).~      Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment~     attendance, treatment satisfaction, and any differences in these rates by groups.~      Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly~     greater treatment satisfaction rating by subjects, as well as by therapists and milieu staff.~      Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and~     externalizing symptoms.~      Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer~     internalizing and externalizing symptoms.~      Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation,~     risk taking, and social skills, and reducing depression.~      Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have significantly~     greater improvement in adaptive coping skills, emotion regulation, risk taking and~     impulsivity and social skills, and reducing depressive symptoms.~      Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents.~      Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer~     critical incidents, including psychiatric hospitalization, emergency room visits, total~     number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual acting~     out, running away, stealing, police involvement, etc.~      II: Finalize therapist training manuals and educational materials to guide selection,~     training, and supervision of treatment providers.~   "
154269|NCT01547039|"~     The purpose of this study is to analyze the association between aspirin efficacy and general~     platelet reactivity in relation to microembolic signals (MES) during carotid endarterectomy~     (CEA).~   "
154270|NCT01547026|"~     Patients who suffer from diseases of the schizophrenia spectrum are frequently burdened by~     weight gain. Sport programs have been shown to improve somatic and psychological health.~     However, the motivation to participate in sports therapy is usually impaired due to~     illness-related factors such as anhedonia and negative symptoms. Previous attempts to~     increase participation in sports therapy have used psycho-educational and behavioral attempts~     that require a lot of resources. In this study the investigators will use a brief method~     developed in experimental social psychology to build up implementation intentions. This~     method has been shown to improve psychological test performance in schizophrenia patients but~     has never been used in a clinical context.~      In two psychiatric hospitals, in-patients with schizophrenia who have been examined by a~     medical doctor, for whom any medical concerns for sports therapy participation have been~     excluded and who declared their motivation to participate in an existing standard sports~     exercise program will be recruited for the study. After information on the study and signing~     of an informed consent patients will be randomly assigned to two treatment conditions. In the~     control condition, the main therapist will individually deliver a 10-minute psycho-education~     on the helpfulness of sports to improve the health; this will be repeated in a shorter form~     in the regular individual treatment sessions over the following weeks. The intervention~     condition will use a structured procedure of the same duration to build up implementation~     intentions to participate in the sports therapy. The implementation intentions will briefly~     be repeated and updated in the following session.~      Primary outcome variables will be percentage of attended sport therapy sessions, persistence~     and compliance. Secondary outcome variables will be Body Mass Index. As confounding variables~     the investigators will assess amount of anti-psychotic medication in Chlorpromazine~     equivalents, negative and depressive symptoms, usual sport activities and cognitive~     impairments.~      The investigators expect that building up implementation intentions will increase~     participation, persistence and compliance of the patients in the sports and exercise therapy~     program compared to the patients who just have received psycho-education.~   "
154271|NCT01547013|"~     This is a study intended to evaluate a new device that uses light to measure the amount of~     oxygen in the muscles of injured and non-injured legs and forearms in specific situations.~     The name of this technology is NIRS (near-infrared spectroscopy). This is a prospective~     observational cohort study intended to gather data using NIRS among injured and noninjured~     extremities over time. Additionally, this data will help in establishing diagnostic perfusion~     value thresholds to be used in a subsequent interventional study confirming the efficacy of~     NIRS-based ACS monitoring.~   "
154272|NCT01547000|"~     The goal of this pilot study is to obtain preliminary information on the tolerability and~     efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette~     Disorder (TD, also called Tourette syndrome).~   "
154273|NCT01546987|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid~     17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of~     androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells.~     This may be an effective treatment for prostate cancer when combined with hormone therapy.~     Studying quality-of-life in patients having cancer treatment may help identify the~     intermediate- and long-term effects of treatment on patients with prostate cancer.~      PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including~     TAK-700, together with radiation therapy in treating patients with prostate cancer.~   "
154274|NCT01546974|"~     The purpose of this study is to determine which humidification system is more effective in~     preventing pneumonia in mechanically ventilated patients. The study will compare a heat and~     moisture exchanger versus heated humidification.~   "
154275|NCT01546961|"~     For the treatment of P.vivax the standard treatment is chloroquine. There is a growing body~     of evidence suggesting that pregnant women may require different doses of drugs, including~     antimalarials due to the physiological changes of pregnancy. It is important that any drug~     used in pregnant women it is given at the correct dose. The only way to evaluate this is by~     pharmacokinetic studies. The investigators propose to evaluate the pharmacokinetics of~     chloroquine when use to treat P.vivax in the 2nd or 3rd trimester of pregnancy. The same~     evaluation in the same woman post-partum is required as a control.~   "
154565|NCT01543152|"~     The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral~     load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion.~   "
154276|NCT01546948|"~     The primary aim of this randomized, double-blind study is to examine the effect of a single~     intraoperative dose of methadone on analgesic requirements during the first three days after~     hepatobiliary or foregut surgery. These patients will be compared to subjects receiving a~     standard dose of the traditional intraoperative opioid (hydromorphone). Secondary outcome~     measures to be assessed will include postoperative pain scores and standard recovery~     variables such as hospital length of stay.~   "
154277|NCT01546935|"~     Currently, there is no treatment for children less than one year of age with influenza~     related lower respiratory tract infection that is either considered standard or registered in~     any country. This dismal scenario exists even though influenza related LRTI is a significant~     illness causing morbidity and mortality, especially in children less than 6 months of age.~     Avian influenza has been reported rarely in children less than one.~      There are no data in Vietnam and very few data in Thailand on the burden of influenza in~     children less than one. This young age group suffers high mortality. Oseltamivir may be~     beneficial in such children. This is basis of this trial.~   "
154278|NCT01546922|"~     The aim of this study is to investigate whether a physiologically low hydrocortisone (HC)~     dose is better for cognition as compared to a physiologically high HC dose. In addition,~     quality of life, metabolic profile and somatosensation will be described in relation to HC~     dose.~   "
154279|NCT01546909|"~     PRIMARY OBJECTIVES~        -  To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or~          DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and~          poliovirus types 1, 2 and 3~        -  To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses~          against diphtheria, tetanus, and poliovirus types 1, 2 and 3~      SECONDARY OBJECTIVES~        -  To describe other parameters of the antibody persistence against diphtheria, tetanus and~          poliomyelitis antigens~        -  To describe other parameters of the immune responses to diphtheria, tetanus and~          poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE~        -  To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE~   "
154280|NCT01546896|"~     This research aims to investigate the efficacy and safety of buspirone in treating~     generalized anxiety disorder with depressive symptoms and to evaluate its neuroprotective~     effects using magnetic resonance imaging.~   "
154281|NCT01546883|"~     This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an~     anti-coagulant for a period of one year to see if there are any significant changes in the~     degree of left atrial structural remodeling in these patients. The investigators hypothesize~     that there will be a significant decrease in the degree of left atrial structural remodeling~     (fibrosis) in AF patients treated with dabigatran.~   "
154282|NCT01546870|"~     Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality~     in pediatric heart transplantation (PHT). Understanding the pathophysiology and early~     detection along with attempted medical management are crucial in preventing advancement of~     the disease and retransplantation or mortality. Coronary angiogram, although routinely used~     is insensitive to detect early TCAD. Measurement of fractional flow reserve (FFR), coronary~     flow reserve (CFR) and index of microvascular resistance (IMR) using a doppler pressure and~     flow intracoronary wire may be more sensitive in evaluating the integrity of coronary~     vasculature and thus detect pre clinical TCAD. To the best of the investigators knowledge,~     measurement of these parameters has not been previously reported in PHT.~   "
154283|NCT01546857|"~     This study is being done to determine if a drug called gabapentin helps in the postoperative~     management of patients undergoing hip and knee operations. The investigators wish to~     determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a~     patient's pain and improve sleep, the patient will be better able to participate in their~     physical therapy. Gabapentin has already been shown to lessen postoperative pain when given~     before surgery. In healthy patients, it has also been shown to improve certain aspects of~     sleep. We hope to identify the effect of the drug, when given after surgery, on patients'~     pain and sleep.~   "
154284|NCT01546844|"~     This purpose of this is study is to evaluate the effectiveness of an interactive mobile~     health information service, Care4Life, in supporting patient self-management of Type II~     Diabetes Mellitus.~   "
154285|NCT01546818|"~     The purpose of this study is to examine the safety, tolerability, and immune response to~     killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected~     individuals.~   "
154286|NCT01546805|"~     The purpose of this study is to determine whether zinc supplements are effective in enhancing~     the treatment of oculofacial spasm disorders with botulinum toxin.~   "
154287|NCT01546792|"~     Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by~     interrupted breathing while sleeping. It is associated with cardiovascular problems such as~     high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are~     overweight and have impaired quality of life. Lifestyle interventions incorporating exercise~     training, dietary advice and behaviour change have been shown to elicit favourable changes in~     quality of life, body mass/composition and cardiovascular risk in a range of patient groups.~     However, no study has investigated the impact of lifestyle modification on such health~     outcomes in patients with OSAHS. This study will address this issue by investigating the~     effects of a lifestyle intervention on quality of life, body mass/composition and~     cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and~     randomly allocated to one of the two groups. Patients in the intervention group will be~     offered a 12-week individualised lifestyle programme consisting of supervised exercise~     training, dietary advice and behaviour change counselling. Patients in the control group will~     receive an educational booklet detailing healthy eating and exercise guidelines but no~     supervised or structured intervention. The results of this study will inform the design of a~     larger, multi-centre randomised controlled trial.~   "
154288|NCT01546779|"~     Cystic Fibrosis (CF) patients perform airway clearance incorporating various breathing~     strategies, to clear secretions from their lungs. Hand held devices may aid mucus~     expectoration, and also motivate the patient to manage by themselves. Our aims was to study~     if resistive expiration through volumetric incentive spirometer (VISex) can improve lung~     function in the short term in Cystic Fibrosis (CF) patients.~   "
165377|NCT01401062|"~     The purpose of this study is to test safety of combining fresolimumab and local radiotherapy~     and to see if the combination can achieve tumor regression.~   "
154289|NCT01546766|"~     The basic objective of this project is to test a modification of existing technology for~     monitoring the responses of the pupil to light as a method for detecting regional losses of~     function of the retina. The instrument consists of a commercially available set of goggles~     that monitor the eye positions and pupils using infrared light and small cameras. The signals~     from the monitoring cameras are collected in a computer that records how their pupils have~     responded to each lighting condition. Because diabetics develop damage initially to certain~     parts of the retina before they have more serious damage, the ultimate goal of this research~     is to develop a simple, noninvasive, rapid method for widespread screening of diabetics in~     order to identify those who may require medical attention and/or therapy for diabetic~     retinopathy.~   "
154290|NCT01546753|"~     The purpose of this study is to determine if walnut oral immunotherapy can be used in~     subjects allergic to tree nuts to reduce tree nut allergy and induce changes in the subject's~     immune system.~   "
154291|NCT01546740|"~     there is a variety of glaucoma prevalence within different populations. this study examine~     the prevalence of glaucoma in the Arab population in Israel' as well as the demographic~     variables and the compliance to treatment in the population.~   "
154292|NCT01546727|"~     This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic~     and home family behavioral intervention (LAUNCH) against 1) motivational interviewing~     (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168~     children ages 2 to 5 years who meet the criteria for obesity (>95th percentile for body mass~     index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI)~     or standard of care. The primary end-point will be change in BMI z-score at the end of~     treatment. The investigators will also assess maintenance of treatment gains at 6 and 12~     months after treatment, and changes in factors thought to be mechanisms for change in weight~     (food intake and activity level), changes in the obesiogenic environment (parent weight, food~     intake and activity, and changes in the home food environment) and factors that could be~     negatively impacted (parent and child eating and feeding interactions).~   "
154293|NCT01546714|"~     The purpose of this study is to determine rates of sexually transmitted infections (STIs)~     among African American women who have sex with women (AAWSW). In addition, the study is~     interested in better understanding the types of risk behaviors that place AAWSW at risk for~     STIs. The investigators hypothesis is that AAWSW experience high rates of STIs, similar to~     heterosexual African American women. Knowledge gained from this study will guide development~     of interventions to reduce women's risk for these types of infections and will improve how~     AAWSW are screened for STIs.~   "
154294|NCT01546701|"~     The purpose of this study is to determine whether sublingual Buprenorphine is as effective as~     Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency~     department.~   "
154295|NCT01546688|"~     A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide~     arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be~     administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).~   "
154296|NCT01546675|"~     The purpose of this pilot study was to conduct a head-to-head comparison of two designs for~     transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket~     design hypothesized to provide greater skeletal stabilization. The investigators comparisons~     included assessments of patient comfort and satisfaction with fit, as well as dynamic~     kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel~     high-speed, high-resolution, bi-plane video radiography system.~   "
154297|NCT01546662|"~     The study will be conducted in two phases. First phase will be 16 weeks study to assess the~     safety, efficacy & to determine the most appropriate dose. Will consist of following visits.~      Phase II (Extended Follow-up): At the end of Day 112, an interim analysis will be conducted~     to assess the sustained efficacy of the investigational product and accordingly the study~     will enter into phase II.~   "
154298|NCT01546649|"~     Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated~     against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal~     breast cancer~   "
154299|NCT01546636|"~     The aim of this clinical investigation is to determine the effect of intraoperative~     ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder~     surgery in the beach chair position (BCP)~   "
154300|NCT01546623|"~     The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and~     efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously~     treated with hormonal therapy.~   "
154301|NCT01546610|"~     The present study aims to evaluate the effect of insoles for foot arthritis.~   "
154302|NCT01546597|"~     The purpose of this study is to evaluate the effect of steady-state ranolazine on the steady~     state PK of metformin in subjects with type 2 diabetes mellitus (T2DM).~   "
154303|NCT01546571|"~     The purpose of this study is to determine how safe and how well POL-103A works in preventing~     the relapse of melanoma after patients who have undergone surgery.~   "
154304|NCT01546558|"~     The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on~     the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes mellitus~     (T2DM).~   "
154305|NCT01546545|"~     This study is designed to determine whether a person's sensitivity to their own insulin~     varies from the morning to the evening.~   "
154306|NCT01546532|"~     This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with~     chronic heart failure. In addition safety and effects on renal function and biomarkers will~     be assessed.~   "
154307|NCT01546519|"~     This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate the~     pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies~     (including hepatocellular carcinoma and lymphoma) that are refractory to standard therapy or~     for whom no standard therapy exists.~   "
154355|NCT01545882|"~     This study is being offered to patients who have hormone resistant prostate cancer (HRPC).~     This means that their prostate cancer is no longer responding to standard hormonal therapy.~      The purpose of this study is to determine whether Degarelix will be able to stop the PSA from~     rising in patients with hormone resistant prostate cancer.~   "
154308|NCT01546506|"~     Rationale:~      Classical antiviral therapies target viral proteins and are consequently subject to~     resistance. To counteract this limitation, alternative strategies have been developed that~     target cellular factors. We hypothesized that such an approach could also be useful to~     identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral~     diversity and because of the need to develop therapies against unpredictable viruses as~     recently underlined by the H1N1 pandemic. Gene-expression signature-based screening~     identified broadly effective influenza A antivirals. Midodrine showed great results in~     inhibiting viral growth and was the most suited to confirm its efficacy in vivo.~      The main objective of the study is to assess the efficacy of midodrine taken at usual~     recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus~     Influenza A.~      Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3~     5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as~     the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of~     midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic~     of viral replication; analysis of the frequency of emergence of mutants and associated~     resistance.~      Methods:~      This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years~     infected by influenza A virus. Nasopharyngeal washing will be performed at day 0~     (randomization), 2, 3, 5 to show the viral replication evolution.~      161 patients will be randomized as follows :~        -  Arm 1 : Midodrine, 2.5 mg, 3 times a day~        -  Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon~          area.~   "
154309|NCT01546493|"~     Femoro-acetabular impingement (FAI) is a known cause of hip pain and possibly a major cause~     of adult hip osteoarthritis. The relationship between cam-type FAI deformity characteristics~     and joint degradation to better identify 'at-risk' patients requiring corrective surgery will~     be scrutinized to gain a better understanding of the condition's natural history. The~     influence of certain morphologies (e.g. size and location of the deformity) will be analyzed~     to determine if this leads to aberrant loading of regions of the cartilage and subchondral~     bone, resulting in cartilage damage and joint degradation. Additionally, this research will~     determine if changes in the subchondral bone precede cartilage degeneration.~      The methodology for establishing the morphology/cartilage degeneration relationship includes~     Magnetic Resonance Image (MRI) analysis, three-dimensional motion analysis and computer~     simulation/finite element analysis.~      The outcomes of this research may lead to a reduction in total hip replacement cases by as~     much as 70%, saving many Canadians from a painful and debilitating condition and reducing~     costs to the Canadian health care system by as much as $290 million annually.~   "
154310|NCT01546480|"~     Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to~     persisting inflammation.~      The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod~     at patients 12 months after the operation.~      DNA-samples are collected to examine genetical factors, important for perception of pain, and~     the development of chronic pain.~   "
154311|NCT01546467|"~     The purpose of the study is to investigate the effect of a 30 hour cognitive remediation~     program for young patients with early phase schizophrenia spectrum disorders on cognitive,~     clinical and functional outcome measures. The remediation program is integrated with whatever~     active rehabilitation the participant is currently attending (school, work, day program etc).~   "
154312|NCT01546454|"~     Women who have regular menstrual cycles have a lower risk of heart disease than men of the~     same age or women who no longer have menstrual cycles. The purpose of this study is to help~     determine why the menstrual cycle causes a lower risk of heart disease. The investigators~     believe that the hormones (estradiol and progesterone) produced during the menstrual cycle,~     as well as the normal processes occurring in the follicle and corpus luteum (transformed~     follicle), change levels of good and bad cholesterol in the blood-stream. These levels of~     good and bad cholesterol are an important risk factor for heart disease. Therefore, our goal~     is to determine what effects each of these factors (estradiol, progesterone, follicle, corpus~     luteum) have on the levels of good and bad cholesterol in the woman's bloodstream. As many~     women take birth control pills, which contain synthetic forms of estradiol and progesterone~     that block ovulation and development of a corpus luteum, the investigators also want to~     determine what effect one common type of birth control pill has on levels of good and bad~     cholesterol.~   "
154313|NCT01546441|"~     The IMPACT Plus Integrated Complex Care Clinic will create a team model of simultaneous~     interprofessional consultation and planning that brings together patients with complex or~     multiple chronic diseases, significant others/caregivers, the primary care team, community~     care providers and, uniquely, secondary consultation in real time at the primary care site.~     The purpose of this study is to evaluate whether the IMPACT clinic will reduce admission to~     hospital and visits to the emergency department (ED) in comparison to a control (usual care)~     group during a one year period of observation. Chart audits will be conducted on a monthly~     basis to calculate patients' complexity scores and data on all health services provided~     during the intervention phase, and compared between the intervention and control group.~     Additionally, surveys and semi-structured interviews aimed to measure patient, caregiver, and~     healthcare professional satisfaction of the IMPACT+ prior to and after initial assessment~     will be collected.~   "
154314|NCT01546428|"~     INC280 will be administered to Japanese patients with advanced soid tumors whose disease has~     progressed despite standard therapy or for whom no standard therapy exists. The trial will~     assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280~   "
154315|NCT01546415|"~     The study is designed to collect safety and efficacy of Desferasirox in Chinese patients with~     Iron Overload and Aplastic Anemia.~   "
154369|NCT01545700|"~     The question of a possible hyperglycemic effect from single-dose dexamethasone is an~     important issue for clinicians managing patients in the intraoperative and postoperative~     periods. Recent evidence suggests that even moderate elevations in blood glucose levels may~     be associated with adverse events.~      The aim of this clinical investigation is to determine whether standard clinical doses of~     dexamethasone produce hyperglycemia in the perioperative period.~   "
154566|NCT01543139|"~     This proposed research is aimed to investigate the efficacy and safety of combined cytidine-~     and creatine-containing drug and dietary supplement in treating bipolar depression and to~     evaluate changes in relevant brain biochemical metabolism using magnetic resonance~     spectroscopy.~   "
154316|NCT01546402|"~     This study is undertaken to determine the effect of intravitreal long acting dexamethasone~     implant, (Ozurdex®) in improving outcome of cataract surgery in patients with diabetic~     macular edema.~      Diabetic Macular Edema and cataract constitute important causes of visual impairment in~     patients with diabetes. Cataract surgery in patients with diabetic retinopathy is associated~     with progression of retinopathy.~      Several modalities such as non-steroidal anti-inflammatory agents, carbonic anhydrase~     inhibitors, corticosteroids, hyperbaric oxygen, laser photocoagulation and vitrectomy with~     internal limiting membrane peeling have been tried for managing inflammatory cystoid macular~     edema.~      Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to~     reduce the retinal thickness and improve the visual acuity. However, recurrence of macular~     edema in patients who receive intravitreal TA is a major concern as the patients need~     multiple repeat injections.~      In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug~     Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently~     developed. Promising results have been shown in certain patients with persistent diabetic~     macular edema receiving this intravitreal drug delivery system with improvement in visual~     acuity~      The present study introduces a novel concept of using intraoperative Ozurdex ® implant in~     patients with diabetes mellitus while undergoing cataract surgery to minimize the worsening~     of diabetic maculopathy.~   "
154317|NCT01546389|"~     This study will randomize 30 healthy adult participants to one of three cohorts comprised of~     six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID~     route. The goal will be to determine the optimal dose required to achieve 100% infectivity~     (ID100) of adult volunteers with P. falciparum malaria.~   "
154318|NCT01546376|"~     Objectives: To study immunostatus (CD4) and HIV viral load in HIV-cancer patients before RT~     and last weeks of RT .~   "
154319|NCT01546363|"~     The purpose of this study is to measure the levels of serum proteins and other biomarkers in~     cervical cancer patients. We believe that some of these markers may be useful in selecting~     patients for specific types of cancer therapies. These markers may also help to predict~     response to therapy, relapse after therapy, and survival after therapy.~   "
154320|NCT01546350|"~     The investigators propose to perform a clinical randomized trial to evaluate the effect of~     single embryo (blastocyst) transfer (SET) with array CGH for the evaluation of the complete~     chromosome complement of the blastocyst in comparison to standard ART methods in which one or~     more embryo are replaced. Patients will be randomized into two groups:~        -  Control group: patients will have up to two embryos replaced on day 5 based on~          morphological and developmental characteristics, and the other embryos reaching~          blastocyst stage will be vitrified. If patients in the control group do not have a~          pregnancy to term from that fresh cycle, they will be offered free PGD either for the~          frozen embryos of that cycle or for the next cycle (up to the center and patient). Data~          from that PGD is not part of the study.~        -  Test group: patients will have grade A,B or C blastocysts hatched on day 5, biopsied on~          day 5, analyzed by array CGH, and a single euploid embryo transferred on day 6. Any~          morulas developing to grade A,B or C blastocyst on day-6 will be also analyzed but~          vitrified for use in a future cycle.~   "
154321|NCT01546337|"~     Anemia is common among cancer patients and the treatment of choice is now~     Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment.~     The purpose of this study is to evaluate the predictive value of endogenous erythropoietin~     rate on the response to erythropoietin beta. First, by confirming the predictive value of~     endogenous erythropoietin observed / predicted ratio on this response. Then if it is~     confirmed by establishing the optimal value of this ratio.~   "
154322|NCT01546324|"~     The purpose of this study is to collect blood samples from pregnant women who achieved~     pregnancy following in-vitro fertilization (IVF) with Natera's preimplantation aneuploidy~     screening (with or without single gene gene testing). These samples will be used for test~     development of non-invasive prenatal diagnostic testing.~   "
154323|NCT01546311|"~     The primary objective of this study is to assess the effectiveness of the pro-active dynamic~     socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees~     during ambulation and rest, addressing residual limb volume fluctuations with a controlled~     flow bladder system.~   "
154324|NCT01546298|"~     This study hopes to improve the investigators understanding of how the immune system acts in~     allergic contact dermatitis. In order to reach this goal, normal volunteers, who are~     suspected of having allergic contact dermatitis, will be patch tested for the fifteen most~     common allergens. Then, biopsies will be taken of the skin at the sites where the there is a~     positive reaction to the allergen. Also, small biopsies will be taken from an area that~     received a patch but no allergen and an area that did not receive a patch to serve as~     controls. In a second stage of the study, volunteers will receive patches with the allergen~     to which they demonstrated an allergic response. More biopsies will be taken, over three~     designated time points. The biopsied skin samples will then be studied in a laboratory.~   "
154325|NCT01546285|"~     The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient~     Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.~   "
154326|NCT01546272|"~     A surgery made by an external incision requires to stitch the subcutaneous plans, usually~     performed using absorbable synthetic sutures hold on wire needle. This national, prospective,~     multicentric, and randomized study is devoted to estimate a technique of suture of the~     subcutaneous plans based on an implantable medical device delivering automatically absorbable~     staples. This particularly innovative technique lets to expect a tolerance and an efficiency~     at least equivalent to the reference technique (main objective). Moreover, this technique~     allows to anticipate a reduction of the duration of surgical procedure and anesthetic time~     while limiting the risks of blood wounds of the medical staff.The medical economic part of~     this study will check, from the point of view of the health care hospital, wether the~     technique is likely to reduce the costs and time consuming theater room procedures.~   "
154414|NCT01545115|"~     Longitudinal survey in Northern Senegal to investigate the environmental factors modulating~     the immune response to childhood vaccines and to malaria.~      A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor~     District) was followed-up for 18 months. During that period, 5 visits have been made to the~     villages to assess the immunological and nutritional status of the children.~   "
154327|NCT01546259|"~     Water method with water exchange has been shown to reduce medication requirement and pain~     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated~     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope~     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion~     of air from the colon during insertion by omission of air insufflations and suction removal~     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy~     insertion in average patients and may enhance the success of difficult colonoscopy.~      Female gender and low-body mass index (BMI) is independently associated with incomplete~     colonoscopy, respectively. The investigators postulate that low-BMI female patients may~     benefit from using the water method for colonoscopy. In this proposal the investigators test~     the hypothesis that compared with conventional air insufflations the water method with water~     exchange significantly enhances the success rate of cecal intubation in low-BMI female~     patients.~      The aim of the study is to compare the outcome of colonoscopy using the water method versus~     the conventional air method in low-BMI female patients. The primary outcome is cecal~     intubation success rate. The secondary outcomes include cecal intubation time, maximum pain~     score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.~   "
154328|NCT01546246|"~     Water method with water exchange has been shown to reduce medication requirement and pain~     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated~     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope~     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion~     of air from the colon during insertion by omission of air insufflations and suction removal~     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy~     insertion in average patients and may enhance the success of difficult colonoscopy.~      Colonoscopy has been considered the gold standard procedure in screening for colorectal~     disease. However, 5-10% of colonoscopies are incomplete due to patient discomfort, difficult~     anatomy and prior abdominal or pelvic surgery. The investigators postulate that these~     patients may benefit from using the water method for colonoscopy. In this proposal the~     investigators test the hypothesis that compared with conventional air insufflations the water~     method with water exchange significantly enhances the success rate of cecal intubation in~     patients with immediately failed colonoscopy.~      The aim of the study is to compare the outcome of colonoscopy using the water method versus~     the conventional air method in patients with incomplete colonoscopy. The primary outcome is~     cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum~     pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection~     rate.~   "
154329|NCT01546233|"~     The purpose of this study is to compare the fatigue in lung cancer patients receiving~     chemotherapy treatment, between the education programme in self-care a multidisciplinary with~     the group who received standard care.~   "
154330|NCT01546220|"~     Water method with water exchange has been shown to reduce medication requirement and pain~     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated~     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope~     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion~     of air from the colon during insertion by omission of air insufflations and suction removal~     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy~     insertion in average patients and may enhance the success of difficult colonoscopy.~      Older age is independently associated with incomplete colonoscopy, the investigators~     postulate that these patients may benefit from using the water method for colonoscopy. In~     this proposal the investigators test the hypothesis that compared with conventional air~     insufflations the water method with water exchange significantly enhances the success rate of~     cecal intubation in elder patients.~      The aim of the study is to compare the outcome of colonoscopy using the water method versus~     the conventional air method in elder patients. The primary outcome is cecal intubation~     success rate. The secondary outcomes include cecal intubation time, maximum pain score during~     colonoscopy, overall pain score after colonoscopy and adenoma detection rate.~   "
154331|NCT01546207|"~     The goal of this trial is to test the impact of a step-wise approach for catheter ablation of~     recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom~     chambers of the heart), in patients with a previous heart attack for whom catheter ablation~     is clinically indicated.~   "
154332|NCT01546194|"~     In most current academic anesthesia groups, it appears that consent for research is acquired~     on the day of surgery. This practice raises concerns because the hospital may be regarded as~     a coercive environment and there may be the possibility that the immediate preoperative~     environment prohibits adequate time for understanding the research project and making an~     informed decision about participation. However, this is often the only opportunity for~     anesthesiologists to obtain research consent. The aim of the present investigation is to~     utilize a survey study to determine if patients at Evanston Hospital are comfortable~     consenting for research on the day of surgery~   "
154333|NCT01546181|"~     Using an adaptive optics imaging device, retinal structures are observed in healthy and~     diseased subjects.~   "
154334|NCT01546168|"~     In this randomized double-blind study, the investigators would like to compare standard~     practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal~     deviation during AF ablation. The investigators hypothesize that the strategy of esophageal~     deviation will result in safer ablation strategy with a reduction in the incidence of~     esophageal injury as assessed by endoscopy.~   "
154335|NCT01546155|"~     Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain~     will alter the binding properties of ([11C]diprenorphine), a molecule that can be used during~     brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI)~     imaging will be used in this study.~   "
154336|NCT01546142|"~     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of~     submental fat (fat below the chin).~   "
154461|NCT01544504|"~     This study, a nonrandomized open-label safety and exploratory study, will evaluate the safety~     of topical norepinephrine in post-surgical breast cancer patients who are undergoing~     radiation therapy.~      The study will also provide information about whether topical norepinephrine can prevent or~     decrease the severity of the radiation dermatitis experienced by these patients.~   "
154337|NCT01546129|"~     Perineal massage at the end of labor stage 2 has been investigated in 2 randomized controlled~     trials using a water soluble lubricant. In one trial a significant reduction of labor stage 2~     has been found, both trials did not show a significant increase of perineum integrity.~      In the HCB Swiss Study both a significant reduction of labor stage 2 by 30 % as well as a~     significant increase of perineal integrity have been shown. No adverse events have been~     reported.~      (see also Obstetric gel shortens second stage of labor and prevents perineal trauma in~     nulliparous women: a randomized controlled trial on labor facilitation. Schaub AF, Litschgi~     M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. J Perinat Med 2008; 36 (2): 129-135).~      Today's practice- Lubricants are widely used to enable manual vaginal examination during~     labor. In Israel midwifes are using Almond Oil for perineal massage at the end of labor stage~     2 to protect the perineum. It has been shown for the first time that the use of the Dianatal~     Obstetric Gel facilitates vaginal childbirth in humans. Dianatal has been introduced to the~     EU markets in 2008.~   "
154338|NCT01546116|"~     -  Entecavir has been one of the option for treatment of lamivudine resistant chronic~          hepatitis B (CHB).~        -  In case of entecavir resistance, adefovir could be used. However, sequential monotherapy~          may result in multidrug resistance.~        -  It is thought that adefovir and lamivudine combination therapy reduce the risk of~          adefovir resistance, thereby continued therapy will lead to suppression of hepatitis B~          virus (HBV) DNA to be undetectable in patients with entecavir resistance.~        -  This study aim to evaluate the efficacy of adefovir and lamivudine combination therapy~          in CHB patients with entecavir resistance.~   "
154339|NCT01546103|"~     The purpose of this research study is to determine whether taking vitamin D, every day, over~     a 12 week period will improve the vitamin D status, risks for poor heart health, risks for~     developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers~     with low vitamin D levels.~   "
154340|NCT01546090|"~     The purpose of this prospective, randomized, double-blind, placebo-controlled study is to~     evaluate the effect of preoperative administration of alprazolam on the success of the IAN~     block for teeth with irreversible pulpitis.~   "
154341|NCT01546077|"~     The purpose of this study is to assess the efficacy of the hydrolocalization technique for~     placement of popliteal perineural catheters in comparison with the stimulating catheters. A~     non inferiority trial.~   "
154342|NCT01546064|"~     The purpose of this study was to compare the incidence and severity of biliary complications~     due to liver transplantation after choledochocholedochostomy with or without a T-tube. A~     per-protocol analysis was designed for recipients of orthotopic liver transplantation in a~     single center, who were randomly assigned to choledochocholedochostomy with or without a~     T-tube. It is a prospective and randomized study.~   "
154343|NCT01546051|"~     This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its~     metabolite BCI-632 and several new pro-drugs in healthy male subjects.~   "
154344|NCT01546038|"~     This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute~     Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents~     used to treat these diseases.~   "
154345|NCT01546025|"~     This is a 2-year research project to test the efficacy of brief motivational intervention for~     reducing heavy alcohol use in young adults transitioning out of high school. Participation~     occurs within 3 months prior to graduation or within 1 year following graduation or dropout~     from high school. Heavy drinkers ages 17-20 will be randomly assigned to receive one session~     of BMI or one session of relaxation training. All participants complete identical assessments~     at baseline and immediately post-intervention (during session 1). Participants also complete~     in-person 6-week and 3-month follow up assessments to evaluate intervention effects. Study~     aims involve: a) testing the comparative efficacy of BMI; b) identifying moderators~     (person-level predictors) of intervention response; and c) identifying mediators (mechanisms)~     of intervention effects, that is, how BMI exerts its effect on outcomes.~   "
154346|NCT01546012|"~     Assess the patient feeling about the handiness of two different vials used to deliver both,~     unpreserved hyaluronic eye drops.~   "
154347|NCT01545999|"~     The purpose of this study is to~        1. assess the effect of PAS in schizophrenia in the dorsolateral prefrontal cortex (DLPFC)~        2. assess the effect of PAS induced long-term potentiation (LTP) on the performance of~          patients with schizophrenia on a cognitive task related to DLFPC.~   "
154348|NCT01545986|"~     The purpose of this study was to compare the effects of two exercise programs, using low~     velocity (LV) and high velocity (HV) contractions, on outcomes of individuals who have~     undergone total knee arthroplasty (TKA). The experimental hypothesis was that individuals~     performing HV exercise, compared to LV, would exhibit superior outcomes.~   "
154349|NCT01545973|"~     The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and~     sweat gland density on Scanning Kelvin Probe measurements.~   "
154350|NCT01545960|"~     The purpose of this study is to characterize the surface electrical potential of acupuncture~     points with a Scanning Kelvin Probe.~   "
154351|NCT01545947|"~     The main purpose of this first study combining an investigational dual mTOR inhibitor,~     CC-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to~     establish a maximum tolerated dose level for each combination in order to evaluate their~     effects in future clinical trials for advanced non-small cell lung cancer.~   "
154352|NCT01545934|"~     The purpose of this study is to study the effects of a multicomponent lifestyle intervention~     that includes partial meal replacements as a means to prevent excessive gestational weight~     gain in obese women. The primary hypothesis is that the intervention will reduce the rate of~     gestational weight gain compared with standard care.~   "
154353|NCT01545921|"~     The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated~     to the end of life for French cancer patients.~   "
154354|NCT01545908|"~     Ulcerative colitis is a condition that mainly affects young adults where the lining of the~     bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and~     treatments remain imperfect with no cure for the disease. Initial success has been shown with~     a highly novel treatment where patients with active ulcerative colitis receive a fecal enema~     to try and replace their stool containing bacteria that may be driving their disease with~     that from a healthy donor. To assess if this works by comparing how well it treats the~     disease compared to a placebo enema.~   "
154356|NCT01545869|"~     Freckles are clusters of melanin in the superficial epidermis. They affect mostly face and~     sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a~     fair complexion patient, but may be present in other skin types.~      The gold standard in the industry for non-surgical facial rejuvenation, removal of wrinkles,~     pigmentation, and general sun damage has been the carbon dioxide (CO2) laser since the mid~     1990s. The traditional CO2 laser was very effective, however it fell out of favor because it~     required general anesthesia. It also had a prolonged recovery time. Over the last several~     years, advances in technology known as fractional resurfacing has made the CO2 laser popular~     again: Fractional CO2 laser treatment is one of the newest laser rejuvenation technology. It~     proved successful in treatment of melasma, one of the pigmented dermatoses. To the best of~     our knowledge, based on a thorough search of literature, no clinical studies assessing~     fractional CO2 laser in treatment of freckles could be retrieved.~   "
154357|NCT01545856|"~     Cardiovascular (CV) disease is a common comorbidity of Parkinson's disease (PD). The~     background incidence rate of CV events in a levodopa-treated PD population was assessed to~     better understand these comorbidities in the PD population. One objective of the study is to~     identify a population of prevalent PD patients with incident levodopa use within the years~     2004-2010 on the Integrated Health Care Information Services (IHCIS) database. The second~     objective is to report the incidence of CV events overall and during intervals 0-6, 6-12 and~     12-18 months after first prescription of levodopa among all new levodopa users.~   "
154358|NCT01545843|"~     The purpose of the study is to determine whether changing sleep patterns improves response to~     an antidepressant medication.~   "
154359|NCT01545830|"~     Vitamin D deficiency is widespread and appears to represent one easily and inexpensively~     modifiable risk factor for diabetes and cardiovascular disease. More than 40 years of data~     link hypovitaminosis D to metabolic syndrome, insulin resistance, hyperglycemia, type 2~     diabetes and increased cardiovascular risk.~      Screening for vitamin D deficiency followed by supplementation in appropriate individuals~     could be among the simplest and most cost-effective measures for reducing metabolic syndrome~     and insulin resistance in the general population.~      This study will test the hypothesis that increasing vitamin D status in vitamin D deficient~     individuals with metabolic syndrome will:~        1. reduce multiple serum cardiometabolic risk factors for both diabetes and cardiovascular~          disease,~        2. stabilize or reverse the stage of pre-diabetes,~        3. improve quality of life, and,~        4. improve the ability to make health-related behavioral changes.~   "
154360|NCT01545817|"~     Study to determine the efficacy, safety and tolerability of first-line pazopanib followed by~     second-line everolimus in metastatic and advanced renal cell carcinoma~   "
154361|NCT01545804|"~     This is a single-arm, open-label phase II trial. Eligible patients must have histological or~     clinical diagnosis of Hepatocellular Carcinoma (HCC), advanced tumors that are not amenable~     to loco-regional therapy, documented progression with or intolerance to sorafenib-based~     treatment or other anti-angiogenic therapy as first-line therapy for advanced HCC.~   "
154362|NCT01545791|"~     This study is conducted in Europe. The aim of the study is to observe the safety of insulin~     detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.~   "
154363|NCT01545778|"~     The purpose of this study is to compare the risk of shopping behavior of tapentadol immediate~     release with the risk of shopping behavior of oxycodone immediate release.~   "
154364|NCT01545765|"~     The purpose of this study is to evaluate the duration of anesthetic effect produced ,~     Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face~     and thigh.~   "
154365|NCT01545752|"~     Using different methods of electronic learning has been increasingly developed by emerging~     electronic educational technologies. They could apply on the net, CDs, Mobile, etc in~     different usage alternatives: interactive and non-interactive both in online and off-line~     approaches. In this educational trial, the interactive and non-interactive CD-based method~     for teaching medical terminology to nursing students of MUMS school of nursing and Midwifery~     during 2009-2012 was compared.~   "
154366|NCT01545739|"~     The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac~     resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and~     efficacy of these pacemakers. In particular, the left ventricular (LV) capture control~     feature is evaluated, which automatically measures the LV pacing threshold and subsequently~     adjusts the pacing output.~   "
154367|NCT01545726|"~     This study will assess the safety and efficacy of QAW039 when added to current therapy in~     patients that have sputum eosinophilia and persistent asthma.~   "
154368|NCT01545713|"~     Antibody Mediated Rejection (AMR) is a major complication of solid organ transplantation. The~     main reason for AMR is pre-formed, or de-novo, donor specific antibodies against the donor~     human leukocyte antigens (HLA). Additional potential targets are antibodies against MIC-A~     antigens or antibodies against targets expressed on the donor endothelial cells.~      Until recently, no specific means were available to test for the presence of donor-specific~     endothelial cell antibodies. The newly introduced XM-One AbSorber® assay allows isolating~     precursor endothelial cells from donor peripheral blood, and thus assessing the presence of~     donor-specific endothelial cell antibodies.~      XM-One AbSorber® is an in-vitro assay that allows for the specific enrichment of precursor~     endothelial cells which in turn promotes endothelial cells specific cross match testing.~      This assay is currently being used in an on-going Northwestern University (NU) research study~     (STU#00029988). The preliminary results of this study indicate that indeed some of the~     patients test positive against their respective donors. One potential explanation for this~     observation, that was not previously entertained, is that the antibodies causing the positive~     cross match response are actually of autoimmune nature. In order to rule-out such a potential~     explanation the investigators would like to further test these patients by performing an~     autologous XM-One AbSorber® assay in which the recipient sera will be incubated with the~     patients' own cells (as opposed to the respective donor cells in the parental study). This~     information is crucial for proper analysis of the data obtained in the NU STU#00029988 study.~   "
154480|NCT01544257|"~     The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented~     and results from previous studies suggest the association between OMT and length of stay~     (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of~     the present study is to show the effect of OMT on LOS in a sample of premature infants.~   "
154370|NCT01545687|"~     RATIONALE: Lactobacillus bevis CD2 lozenge may help prevent symptoms of mucositis, or mouth~     sores, in patients receiving radiation therapy and chemotherapy. This therapy may improve the~     quality of life of patients with head and neck cancer.~      PURPOSE: This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral~     mucositis in patients with head and neck cancer who are being treated with cisplatin and~     radiation therapy. These results will be compared to results in patients using placebo~     lozenges.~   "
154371|NCT01545674|"~     This prospective blinded study will assess the diagnostic capability of an informatics~     enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying~     a fetus with an aneuploidy from fee floating DNA in the maternal blood.~   "
154372|NCT01545661|"~     This study will investigate the benefit of using Sputum induction for TB diagnosis in a~     primary care clinic for adult TB suspects that are either unable to produce a sputum sample~     (sputum scarce) or on initial diagnostic work-up have 2 negative sputum smear samples (WHO~     standard for frontline TB diagnosis). The investigators hypothesize that acquiring an induced~     sputum sample for smear microscopy and liquid TB culture will decrease time-to-diagnosis and~     time-to-treatment initiation in smear negative/sputum scarce TB patients in a primary care~     clinic in a resource-limited high TB HIV prevalent setting.~   "
154373|NCT01545648|"~     The purpose of this study is to see whether taking denosumab for 12 months in women with a~     significant number of disseminated tumor cells in the bone marrow can reduce the number of~     these cells below a significant level.~   "
154374|NCT01545635|"~     Severe traumatized patients (ISS > 15) admitted to emergency department (ED) University~     Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage~     will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and~     subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient~     meets the inclusion criteria (T1) and is recruited for the study, a first study related blood~     sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be~     randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or~     FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive~     fresh frozen plasma (FFP),respectively.~      Treatment failure will be registered if bleeding persists and ROTEM parameters do not improve~     after two times dosages of study drug. In these cases haemostatic rescue therapy will be~     administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will be~     administered to patients randomized to receive FFP and FFP will be administered to patients~     of the CFC group.~      In cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse~     bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII~     concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy~     will be documented and a ROTEM will be performed thereafter.~      At admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study related~     blood samples are drawn (40mL each).~      The indications for transfusion of red blood cells or platelets, administration of~     antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement~     are similar for both groups and treatment is performed according to clinical routine.~      Besides coagulation management during ED treatment until 24h on ICU, patient's care is not~     influenced by the study and follows clinical routine.~   "
154375|NCT01545622|"~     The purpose of this study is to analyze the findings of 30 surgeons and 30 nuclear~     radiologists of 61 individual thyroid scans. The goal is to determine if surgeons are more~     prone to making a definitive diagnosis based on a given scan than a nuclear radiologist.~     Accuracy of localization of the two groups will be analyzed. A secure website has been~     designed to which the physician will be able to login and view and rate the quality of each~     image and make a localizing diagnosis. Once they are finished, they will not be able to make~     any more changes, and their responses will be compared to the responses of their colleagues.~     The results will be analyzed to find if there is a significant variation in the ratings~     between the surgeons and the nuclear radiologists as to the quality, location, and number of~     parathyroid glands, if any, on the scans.~   "
154376|NCT01545609|"~     This study is a randomized controlled trial assessing the effectiveness in a series of~     educational text messages in improving continuation of a birth control method in comparison~     to the 'standard counseling', when girls initiate a new method of birth control. Girls aged~     15-19 year olds who are attending for a reproductive health visit and who own a working cell~     phone will be approached and asked if they would like to participate. Following completion of~     a baseline questionnaire and consultation for initiation of a new birth control method they~     will be randomized to receive either the intervention or standard counseling.~      If randomized to the intervention they will receive 3 messages per week for the initial 3~     weeks, 2 messages per week for the following 5 weeks and then one message per week~     thereafter. Messages will be tailored to the birth control method the participant has~     initiated. At 4 months all participants will be contacted via telephone and asked to complete~     a questionnaire regarding continuation of use.~   "
154377|NCT01545596|"~     The objective of this study is to use a decision-support system combined with an electronic~     anesthesia record to detect double low clinical conditions (Mean Arterial Pressure (MAP) < 75~     mmHg, and Bispectral Index (BIS) < 45) and generate alerts suggesting hemodynamic support.~     Specifically, the project will test the hypothesis that providing Double Low alerts reduces~     90-day mortality. Secondary outcomes will be the fraction of alerts that generate early~     clinician responses, subsequent changes in MAP and hospital length of stay.~   "
154378|NCT01545583|"~     The purpose of this study is to investigate the safety and tolerability of LY3016859~     administered as single doses, and to determine how long LY3016859 remains in the body~   "
154379|NCT01545570|"~     This is a single-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose~     study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     GSK2374697 in healthy volunteers. The study will enrol approximately 72 subjects at one~     clinical study center in the United States.~   "
154380|NCT01545557|"~     The aim of this study is to assess performance and tolerance as well as investigator and~     subject satisfaction further to pan-facial volume restoration with a new cross-linked~     hyaluronic acid dermal filler containing lidocaine 0.3%.~   "
154381|NCT01545544|"~     An prospective / retrospective multicenter observational study whose objectives are to~     understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The~     characteristics , evolution and treatment of diseases will be observed from the study.~   "
154382|NCT01545531|"~     The purpose of this study is to measure glomerular filtration rate (GFR) by iohexol plasma~     disappearance (gold standard) and measure serum Cystatin C levels (surrogate marker) in~     patients enrolled in our prospective study at baseline, day 100 and 1 year after~     hematopoietic cell transplant and determine if these levels correlate with serum creatinine~     and an estimated GFR using the Modification of Diet in Renal Disease (MDRD) equation and~     Schwartz formula in children.~   "
154383|NCT01545518|"~     The purpose of the initial screening study is to find out if immune problems are an~     unrecognized cause of epilepsy in some patients. This study consists of a single blood~     sample, which will be tested for possible immune abnormalities. If enough patients are found~     who show immune abnormalities, those patients who are still having uncontrolled seizures will~     be invited to participate in a study of immune treatment with a compound called intravenous~     immunoglobulin (IVIG).~      The study hypothesis is that a significant proportion of the young-onset, refractory,~     image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and~     many of these patients will respond to immune therapies, including IVIG.~      At present, the importance of immune abnormalities in causing epilepsy, and the proper~     treatment when they are found, are both poorly understood. The investigators hope that this~     study will help us understand the cause of some cases that are difficult to treat.~   "
154384|NCT01545505|"~     Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors~     predicting PTSD relapse are still unknown. The aim of this study is to examine whether~     clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that~     characterized PTSD can be observed in people with past PTSD (children and their families) and~     whether these persistent changes are predictive of PTSD relapse.~   "
154385|NCT01545492|"~     INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled~     trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP~     (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in~     pregnancy is better for the baby without increasing maternal risk.~      CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to~     non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing~     and a maternal questionnaire about infant feeding practices and background]. Annual contact~     will be maintained in years 2-5 and contact will include annual parental measurement of the~     child's height, weight and waist circumference.~      OBJECTIVE: To directly test, for the first time in humans, whether differential blood~     pressure (BP) control in pregnancy has developmental programming effects, independent of~     birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight')~     control of maternal BP will be associated with fetal under-nutrition and effects will be~     consistent with developmental programming.~   "
154386|NCT01545479|"~     It is well established that renal hypoxia is associated with the development of renal injury.~     The purpose of this study is measure the alterations in renal blood oxygenation after~     angiotensin II converting enzyme inhibition. The understanding of kidney adaptive mechanisms~     to renin angiotensin system effects in healthy subjects will be useful for the early~     detection of renal disease and for the development of new therapies to decrease the~     progression of the disease and its consequences.~   "
154387|NCT01545466|"~     This proposal describes a randomized controlled pilot trial investigating feasibility,~     safety, and migraine frequency in patients with migraines who undergo an 8 week mindfulness~     based stress reduction (MBSR) program compared to a wait-list control group.~   "
154388|NCT01545453|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains~     uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller~     medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment~     with subcutaneous lebrikizumab (highest, middle, lowest dose) or placebo every 4 weeks~     for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a~     52-week double-blind active treatment extension. The anticipated time on study treatment is~     up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study~     drug for all patients.~   "
154389|NCT01545440|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains~     uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller~     medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment~     with subcutaneous lebrikizumab (highest, middle, lowest dose) or placebo every 4 weeks~     for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a~     52-week double-blind active treatment extension. The anticipated time on study treatment is~     up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study~     drug for all patients.~   "
154390|NCT01545427|"~     The purpose of this study is to investigate the effectiveness and safety of the drug Gleevec~     (imatinib) as a new treatment for patients with active diffuse scleroderma. This drug has not~     been used previously to treat scleroderma, but it has been found to advance the treatment and~     life span of patients with a type of leukemia called chronic myeloid leukemia or CML. Gleevec~     acts on chemical signals in the cells that may decrease fibrosis (the hardening of the skin~     that occurs in scleroderma). It works by interfering in the process that activates many~     molecules that cause fibrosis, including TGFbeta (which may be a key part of disease activity~     in scleroderma).~      This study proposes to treat patients that have significant diffuse scleroderma with Gleevec~     for 6 months and investigate several measures of scleroderma disease activity before, during~     and at the end of treatment (0, 3 months and 6 months). This is a randomized, double blind,~     placebo-controlled trial: 20 patients will be divided into two groups in a 4:1 ratio, with 16~     patients taking 400mg of Gleevec per day and 4 taking a placebo. The differences between the~     groups that will be measured include safety, Modified Rodnan skin score (mRSS), Health~     Assessment Questionnaire (HAQ), global assessments (100mm VAS) and changes in biomarkers in~     blood and skin biopsies.~   "
154391|NCT01545414|"~     The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral~     Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety~     symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment~     (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to~     SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that~     ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.~   "
154567|NCT01543126|"~     Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy~     correlate with the prognosis of the disease~   "
166223|NCT01389999|"~     The goal of this study is to carry out a transcultural validation of the Back Belief~     Questionnaire in order to assess its appropriateness for French-speaking populations.~   "
154392|NCT01545401|"~     BACKGROUND~      Chronic disease management (CDM) presents enormous challenges to the primary care workforce~     due to the rising epidemic of cardiovascular risk factors. The Chronic Care Model (CCM) was~     proven effective in improving chronic disease outcomes in developed countries. Evidence that~     this model works in developing countries is still scarce. Therefore, the aim of this study is~     to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted CDM strategies~     based on the CCM) in managing type 2 diabetes mellitus (T2DM) and hypertension (HPT), using~     readily available resources in the Malaysian public primary care setting.~      METHODS~      This is a pragmatic cluster randomised controlled trial - participatory action research which~     is currently being conducted in 10 public primary care clinics in Selangor and Kuala Lumpur,~     Malaysia. Five clinics are randomly selected to provide the EMPOWER-PAR intervention for 1~     year, while the other 5 clinics continued with usual care. Each clinic recruits consecutive~     T2DM and HPT patients who fulfil the inclusion and exclusion criteria over a 2-week period.~      The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary CDM Team;~     and training the team to utilise the Global CV Risks Self-Management Booklet to support~     patient care and reinforcing them to utilise relevant clinical practice guidelines to aid~     management and prescribing.~      For T2DM, primary outcome is the change in the proportion of patients achieving target HbA1c~     of <6.5%. For HPT without T2DM, primary outcome is the change in the proportion of patients~     achieving target blood pressure of <140/90 mmHg. Secondary outcomes include the proportion of~     patients achieving targets serum lipid profile, body mass index and waist circumference.~     Other outcome measures include medication adherence levels, process of care and prescribing~     patterns. Patients' assessment of their chronic disease care, providers' perception, attitude~     and perceived barriers in delivering the care and cost-effectiveness of the intervention are~     also evaluated.~      CONCLUSION~      Results from this study will provide objective evidence of the effectiveness and~     cost-effectiveness of a multifaceted intervention based on the CCM in resource constraint~     public primary care setting. It is hoped that the evidence will instigate the much needed~     primary care system change in Malaysia.~   "
154393|NCT01545388|"~     This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice~     daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes~     mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and~     sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg~     b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from~     baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d.~     is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in~     HbA1c at 24 weeks.~   "
154394|NCT01545375|"~     The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis~     media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine~     GSK2189242A in Native American infants aged less than 24 months, living in the southwestern~     US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the~     impact on acute lower respiratory tract infections (ALRI) up to the second year of life.~   "
154395|NCT01545362|"~     To determine if preop nutritional status is an indicator for outcomes of bilateral staged~     total knee arthroplasty. The investigators expect that patients having staged bilateral total~     knee arthroplasty with the second procedure performed within one week of the first and have a~     total lymphocyte count >1500 per cubic millimeter and serum albumin level >35 grams per liter~     will have the same or less complications and shorter length of stay than those with lower~     lymphocyte count and albumin level.~   "
154396|NCT01545349|"~     This is a Phase I, randomized controlled trial to evaluate the safety of Lactobacillus~     rhamnosus GG (LGG) versus placebo in elderly subjects receiving the live attenuated influenza~     vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of several~     strains of Lactobacilli that is used as a probiotic or microorganism administered to confer~     health benefits. Our research is focused on studying the possible therapeutic effects of~     LGG. The study hypotheses are:~        1. LGG or placebo administered twice daily will be safe and well tolerated in elderly~          subjects who have just received the live attenuated influenza vaccine,~        2. The immune response to the influenza vaccine at day 21, 28, and 56 will be higher in the~          LGG group than the placebo group,~        3. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, and~          56 will be greater in the LGG group than the placebo group.~   "
154397|NCT01545336|"~     The main purpose of this clinical trial is to study the safety and efficacy of anastrozole in~     adults diagnosed with pulmonary arterial hypertension (PAH). The study will evaluate how well~     the drug is tolerated. The study will also evaluate if anastrozole effects estradiol (E2)~     hormone levels, a sex hormone, and improves the function of the lower right chamber of the~     heart (right ventricle).~   "
154398|NCT01545323|"~     Netherton Syndrome is a serious skin disorder caused by damage in a gene called SPINK5. This~     gene controls the formation of a protein called LEKTI, which important for skin barrier~     function. LEKTI inhibits certain enzymes (serine proteinases) in the outermost layer of the~     skin (epidermis). The function of the serine proteinases is to break down the intracellular~     cement that holds together the horny cells in the epidermis, in order for the skin to be able~     to shed cells (known as cell desquamation). LEKTI deficiency leads to an uninhibited~     desquamation of horny cells, and as a result the skin becomes red and scaly. The barrier~     function of the skin is also affected. The permeability of the skin increases, and its~     capacity to bind water decreases, which causes dryness. The thinness of the barrier also~     results in over absorption of chemicals, for example topical medical treatments. Historically~     one in ten infants dies before their first birthday. Currently there are no proven treatments~     to cure this condition.~      The investigators have been developing a gene therapy approach to treat this disorder. The~     investigators have used a disabled virus (vector) to carry a functional copy of the SPINK5~     gene into skin stem cells. Proof-of-principle experiments have shown the investigators can~     restore almost normal shape and size of the upper layer of the skin in skin grafts grown in~     the lab. Even if only a small number of cells are genetically modified to carry the corrected~     SPINK5 gene, there seems to be a correction over a wide area of the graft.~      In this trial the investigators propose grafting of autologous epidermal sheets generated~     from genetically modified skin stem cells for the treatment of patients with Netherton~     Syndrome. The investigators anticipate production and release of LEKTI protein from even a~     small patch of skin will be beneficial.~   "
154399|NCT01545310|"~     This open-label, Phase 1 study will investigate the 5-hydroxytryptamine 6 (5-HT6) receptor~     occupancy in the brain using positron emission tomography (PET) following single oral doses~     of SLV354. Up to 22 healthy male subjects and male subjects with stable schizophrenia,~     between 18-55 years of age are to complete the study.~   "
154436|NCT01544829|"~     The main aim of this study is to determine whether there is a difference in the physiological~     effects of theobromine when provided via a single serving compared to multiple servings~     adding up to the same amount of theobromine provided on a day.~      This study also aims to study the pharmacokinetics of theobromine after administration once~     per day versus administration 4 times per day.~      Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is~     given in 4 smaller doses.~   "
154437|NCT01544816|"~     To determine the effect of snack products varying in composition, on energy in healthy adult~     subjects.~   "
154577|NCT01542983|"~     Women with breast cancer complain of poor sleep and fatigue during chemotherapy which affect~     their mood, their memory and their quality of life. The investigators are testing whether it~     is feasible to treat the poor sleep and fatigue with behavioral treatments, before the start~     of chemotherapy and whether improving sleep and fatigue will also improve mood, memory and~     quality of life.~   "
154400|NCT01545297|"~     Awake craniotomy for resection of brain tumor located in close proximity to areas of eloquent~     brain function, such as speech, motor and sensory, is an accepted procedure used to minimize~     neurological injury during resection. During awake craniotomy, anesthesia is usually provided~     using a combination of local anesthesia (regional scalp block and/or local infiltration) and~     intravenous (IV) agents to provide sedation, anxiolysis and analgesia. Propofol sedation,~     commonly in combination with a shorter acting opioid such as fentanyl, or remifentanil, is an~     effective and popular technique during awake craniotomy, achieving a high degree of patient~     satisfaction and acceptance. Most of the anesthetic agents are associated with some~     respiratory depression.~      The anesthetic agent called dexmedetomidine is a potent, highly selective α2-adrenoceptor~     agonist. The effects of dexmedetomidine are anxiolysis, analgesia, sedation and~     sympatholysis, and it is not associated with respiratory depressive effect. Bekker et al.~     first reported the successful use of dexmedetomidine in awake craniotomy in 2001.~      The purpose of this blinded, prospective, randomized study is to compare the efficacy of~     dexmedetomidine versus propofol-remifentanil based sedation in patients undergoing awake~     craniotomy for resection of tumors. The study hypothesis is that the efficacy of performing~     intra-operative brain mapping is identical between dexmedetomidine and the~     propofol-remifentanil based sedation. The primary end-points are to assess the ability to~     perform intraoperative mapping during awake craniotomy. Secondary end-points will assess the~     incidence of complications (respiratory depression, failure to provide adequate analgesia),~     as well as patient and surgeon satisfaction to the corresponding anesthetic technique.~   "
154401|NCT01545284|"~     This pilot, phase II, 24-week study will recruit a total of 10 patients and will evaluate the~     efficacy and safety of acitretin in patients with severe chronic hand dermatitis .~   "
154402|NCT01545271|"~     This study examines the effect of inhaled xenon gas in the treatment of newborn infants with~     hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard~     treatment for this condition. The hypothesis is that the xenon + cooling combination will~     produce better neuroprotection than the standard treatment of cooling alone.~   "
154403|NCT01545258|"~     A commonly administered conservative non-pharmacological treatment for OA is exercise, with~     beneficial effects in terms of reduced pain and disability.~      While the link between exercise and reduced disability is mediated by e.g. increased muscle~     strength and endurance, the analgesic mechanisms related to exercise are unexplored. knee OA~     patients have both peripheral and central sensitization of pain mechanisms resulting in~     hyperalgesia. Thus, targeted pain treatment in these patients may focus on both peripheral~     and central mechanisms but it unknown if exercise affects either of these mechanisms.~      It is hypothesized that in knee OA patients exercise reduces the pain sensitivity~   "
154404|NCT01545245|"~     The primary objective of the study is to determine whether the incidence of atopic asthma~     after three years old may be suppressed in the children who were born as preterm infants and~     prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections~     during the infancy.~      The secondary objective is to determine whether the incidence of recurrent wheezing after~     three years old may be suppressed in the children who were born as preterm infants and~     prophylactically treated with palivizumab for RS virus infections during the infancy.~   "
154405|NCT01545232|"~     Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial~     designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted~     to receive massive transfusion ([MT] (defined as receiving 10 units or more red blood cells~     (RBCs) within the first 24 hours). The goal of PROPPR is to improve the basis on which~     clinicians make decisions about transfusion protocols for massively bleeding patients.~      PROPPR is a Resuscitation Outcomes Consortium (ROC) Protocol. ROC is funded by the National~     Heart, Lung, and Blood Institute (NHLBI), the United States' Department of Defense (DoD) and~     the Defence Research and Development Canada. PROPPR will be conducted as a Phase III trial at~     Level I Adult Trauma Centers in North America.~   "
154406|NCT01545219|"~     Healthy volunteers will be recruited to a study where they will be given four different~     treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a~     synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be~     collected and analysed for changes in faecal microbial populations and selected immune~     responses.~   "
154407|NCT01545206|"~     The investigators tried to determined whether the less D2B time led to costs savings~     benefited insurance payer and better outcomes to patients.~   "
154408|NCT01545193|"~     Residual neuromuscular blockade is frequently observed in the early postoperative period when~     patients have received a general anesthetic with muscle relaxants. At the present time it is~     uncertain whether certain patient populations are at greater risk for this common anesthetic~     complication. However, it is possible that elderly surgical patients may exhibit a higher~     incidence of residual neuromuscular blockade. The aim of this clinical trial is to determine~     the incidence of residual neuromuscular blockade in a cohort of younger (ages 18-50) and~     older (ages 70-90) patients undergoing surgery and general anesthesia.~   "
154409|NCT01545180|"~     This study will better understand the post-capillary pulmonary hypertension in heart failure,~     to determine its prognostic role and to consider specific treatment of different forms of~     pulmonary hypertension in post-capillary pulmonary heart failure.~   "
154410|NCT01545167|"~     This study will investigate several genes and other factors measured in the blood that may~     cause recurrent acute pancreatitis and chronic pancreatitis. No treatment is offered as part~     of this study. Subjects have one single visit to provide a blood sample for genetic testing~     and to answer a questionnaire. Subjects are not given results of genetic testing. The study~     is currently enrolling African American subjects and controls only.~   "
154411|NCT01545154|"~     This study is being done to find out if transperineal ultrasound (TPUS) can help define the~     prostate gland for radiation treatment planning and improve upon current methods of image~     guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement~     of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they are~     lying on their back in the position they will receive their treatment. Image-guidance is~     required for the treatment of prostate cancer because the prostate shifts position depending~     on how full the bladder and rectum are. Image-guided radiation therapy has been done at~     Fletcher Allen Health Care for approximately three years. Most commonly, transabdominal~     ultrasound images are obtained every day and compared to an ultrasound that was done on the~     day of treatment planning. Adjustments in radiation field position can be done on a daily~     basis by comparing these images. Transperineal ultrasound has never been used for~     image-guidance. The investigators completed an earlier study and have developed a TPUS device~     and process that allow us to get clear ultrasound pictures of the prostate gland. The TPUS~     has three potential advantages over the transabdominal method the investigators currently~     use:~        1. Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get~          clearer images, however it is difficult for some men with prostate cancer to comfortably~          keep a full bladder. It is also particularly difficult to get good images in larger men~          who have long distances from the skin surface to the prostate gland. TPUS is not~          dependent on a man having a full bladder and should be less dependent on the size of the~          man.~        2. TPUS images and the planning CT images can be acquired simultaneously. This is not~          possible with the abdominal probe because it gets in the way of the CT machine.~          Simultaneous imaging eliminates the possibility of the prostate gland shifting positions~          during the time between imaging studies.~        3. TPUS can be in place and acquire images during patient treatment (the abdominal probe~          gets in the way of the treatment machine) and may in the future allow us to watch the~          prostate gland during treatment. If the investigators discover that they can accurately~          view the prostate gland in real time, TPUS may ultimately allow us to treat even smaller~          radiation fields and possibly decrease the risk of radiation complications.~      Patients in this study will be treated for their prostate cancer with the standard image~     guidance techniques used at Fletcher Allen Health Care: transabdominal ultrasound and/or~     X-ray imaging of gold marker seeds that have been placed the prostate gland. In addition to~     standard care, all men in this study will have TPUS and CT scans done a total of four times~     over 12 weeks to compare these methods of prostate localization over the course of radiation~     treatments. Some men may choose to take part in an additional study that will also include~     MRI of the pelvis to compare with the TPUS and CT. Because the prostate gland can be more~     clearly defined on MRI, some institutions (not Fletcher Allen) routinely have patients with~     prostate cancer get MRI scans for treatment planning. This has not been proven to improve the~     care of men with prostate cancer and it is possible that TPUS will provide similarly clear~     images. The potential advantages to TPUS imaging for prostate localization over MRI include~     the fact that it is done at the same time as the CT for treatment planning (so eliminates the~     possibility of movement of the prostate gland from the time of the MRI to the time of the CT)~     and can be done at a much lower cost.~   "
154412|NCT01545141|"~     Determine the safety of a combination of IFN, celecoxib, and rintatolimod for patients with~     recurrent colorectal cancer. This will also test whether the above combination can help the~     immune system to fight the tumors. The results will allow the investigators to determine the~     preferred combination for subsequent extended studies.~   "
154413|NCT01545128|"~     The purpose of this study is to study the direct cost of illness study of COPD patients who~     participated in a Pulmonary rehabilitation program for 8 weeks.~   "
154578|NCT01542970|"~     The incidence of allergic disease has increased worldwide during the last decades. Initially,~     a lot of effort has been put in elucidating which of the known risk factors commonly~     associated to the development of allergic disease early in life was the cause of this~     increase. Studies showing a reduced incidence of allergic disease in the former socialist~     countries in comparison to countries with a Western lifestyle have shown that risk factors~     as allergen exposure, environmental pollution and tobacco exposure are also present in~     societies with a less affluent lifestyle. This suggests the disappearance of factor~     protecting against the development of allergic diseases in affluent environment.The~     development of allergic diseases begins during the first year of life with eczema, both~     non-IgE- and IgE-associated, and food allergy, progressing during childhood with the~     development of asthma bronchiale, also both non-IgE- and IgE-associated, and later~     development of allergic rhinoconjunctivitis, i.e. the atopic march. The immune system of the~     neonate is influenced by maternal immunity, both via the placenta and breast milk. Thus, the~     immunological interaction between the mother and her offspring is close during pregnancy and~     lactation. The association of cord blood IgE levels with maternal but not paternal atopic~     heredity, may depend on a possibly stronger placental Th2 shift in atopic mothers. Thus,~     factors influencing/protecting against the development of allergic disease early in life,~     would be important already during pregnancy, birth and early postnatal life. Two major~     hypotheses have been assessed during the last decade: Proper microbial stimulation, including~     the establishment of the gut flora in infancy and the relationship between low omega~     3-polyunsaturated fatty acids in the western diet and the incidence of allergic disease.~      This is a double blind randomized study. Families with at least one parent/sibling with~     clinical symptoms/history of allergic disease will be invited to participate in this study.~     Pregnant mothers will be included in the study at the 20th week of gestation. They will be~     randomized to 4 study groups, one will receive placebo capsules, the second will receive~     omega-3 PUFA supplementation and placebo regarding L. reuteri, the third will receive L.~     reuteri and placebo regarding omega-3 PUFA and the fourth group will receive both omega-3~     PUFA and L. reuteri supplementation. Omega-3 supplementation will be given to mothers from~     pregnancy and lactation while L. reuteri will be given to the mothers during pregnancy and~     later to the children during the first year of life.The children will be clinically followed~     by an allergy nurse regularly. Questionnaires regarding data on environment, siblings, pets,~     breast feeding, smoking exposure, upper respiratory and other infections and clinical~     symptoms of allergic disease will be filled regularly. Skin prick tests (SPTs) will be~     performed in the children at 6 and 12 months with milk, egg, wheat, peanut and cat. At 24~     months, timothy and birch allergen extracts will be added. A pediatrician will assess the~     children at 24 months of life and whenever it is needed during the study period. Dietary~     habits will be assessed during pregnancy (25th gestational week) and 6 months after child~     birth. Blood samples in the children will be taken from cord blood and at 6, 12 and 24 months~     of life. Maternal blood samples will be taken at 20th weeks of gestation and at child birth.~     Milk samples will be collected 1-4 days after partus and monthly during the first 4 months of~     lactation. Maternal gastrointestinal function will be addressed by validated diary cards.~     Saliva from the children and fecal samples from mother and child will also be collected~     according to the following protocol.~   "
154415|NCT01545102|"~     Cardiac rehabilitation is the ideal comprehensive intervention for patients with chronic~     heart failure (CHF), since it addresses the complex interplay of medical, psychological and~     behavioural factors facing these individuals. Structured exercise training within a cardiac~     rehabilitation programme is firmly recommended for these patients. However, it is~     questionable whether patients are achieving an adequate dose of exercise to provide optimal~     benefits. The essential components for setting optimal training include the appropriate mode,~     duration, frequency and intensity of exercise. UK surveys of cardiac rehabilitation describe~     the frequency and duration of training, but here is scant information on exercise intensity.~     However, it is apparent that randomised controlled trials of exercise training use doses more~     than 4 times greater than in UK current practice. The Eastbourne Exercise Cardiology Research~     Group has demonstrated that although patients benefit from improved quality of life and~     submaximal fitness after a hospital outpatient cardiac rehabilitation programme, they do not~     achieve the increases in important prognostic indicators reported by the majority of exercise~     training trials.~      The critical factor in terms of eliciting a sufficient training effect while minimising risk~     is the intensity of the exercise performed. It is now widely accepted that the traditional~     methods of using fixed percentages of maximal heart rate or oxygen uptake to set exercise~     intensity include serious errors. The European Society of Cardiology recommends that~     cardiopulmonary exercise testing should be used to provide an objective evaluation of the~     metabolic demand of exercise. This allows physiologically meaningful reference points to be~     established for aerobic exercise prescription and is the solution to defining safe and~     effective training intensities. The next step is to determine whether this information can be~     transferred to a practical cardiac rehabilitation environment to set and monitor exercise~     intensity~   "
154416|NCT01545089|"~     The main objective of this research project is to measure the impact on patient satisfaction~     of the use of a fabric mattress cover fabric on a bedsheet protecting a plastic mattress.~   "
154417|NCT01545076|"~     This is a prospective, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20~     compared with placebo for maintenance treatment of patients with CIDP.~      Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks~     before screening will be assessed during 4 separate study periods. Patients first undergo a~     Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for~     ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be~     administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients~     with improved and maintained adjusted inflammatory neuropathy cause and treatment scale~     (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the~     study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly~     infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.~      The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the~     Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical~     Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and~     electrophysiological evaluations.~   "
154418|NCT01545063|"~     This research aims to give an overview of a number of aspects related to the quality of care~     for adult patients on home parenteral nutrition.~      Concretely this study follows up different aspects on different moments in the care of the~     patient pathways:~        -  process indicators concerning indication, parenteral nutrition, training, team access~          roads and the succession of complications~        -  Outcome indicators~        -  the health-related quality of life~        -  discrepancies in medication use~        -  the role of the different health care providers~   "
154419|NCT01545050|"~     The purpose of this study is to characterize the safety, efficacy and dose response of~     BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an~     insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor~     (anti-TNF) therapy.~   "
154420|NCT01545037|"~     The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms~     of IBS.~   "
154421|NCT01545024|"~     Rocca et al. reported first that the secretion of incretins, particular GLP-1 in rat is~     regulated by the enteric nervous system, the afferent and efferent vagus nerves [1]. Further,~     Kazakos et al. [2] reported that autonomic nerve disturbance (AND) in patients with T2DM~     impaired the incretin effect owing to decreased GLP-1 secretion. However, Toft-Nielsen et al.~     [3] reported that the decreased GLP-1 responses in the patients with type 2 diabetes mellitus~     (T2DM) are unlikely to be related to the AND and, thus, did not support the results of Rocca~     et al. and Kazakos et al. Recently, Yabe at al. [4] also observed the same observations in~     Japanese patients with T2DM. Meanwhile, Jin et al. reported that administration of DPP-IV~     inhibitor recovered the disturbance of diabetic nerve dysfunction in rat [5]. However, it is~     unknown whether the administration of DPP-IV inhibitor effects on the AND in human, although~     many studies are performed to investigate the effect of the DPP-IV inhibitors on glycemic~     control.~      Accordingly, it is significant to reinvestigate an effect of DPP-IV inhibitor on glycemic~     control and autonomic neuropathy in diabetic patients.~   "
154422|NCT01545011|"~     The purpose of this study is to determinate whether inspiratory muscle training (IMT)~     associated with a conventional respiratory rehabilitation program is more effective than a~     conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive~     pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP > 60 cmH2O).~   "
154423|NCT01544998|"~     This study is being done to determine the effects of subcutaneous (under the skin) injection~     of human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the~     heart, in combination with Tadalafil on:~        -  The pumping function of the heart~        -  Kidney function~        -  Hormonal function (levels of different hormones in your blood) in persons with lower~          pumping function of their heart.~   "
154447|NCT01544686|"~     In neutropenic cancer patients, catheter-related bloodstream infections may cause severe~     infections and even death. To assess the prophylactic effect of a chlorhexidine coated~     catheter securement dressing on the incidence of catheter-related bloodstream infections,~     this open, randomized trial is being carried out. CHG iv Tegaderm securement dressing will be~     randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.~   "
154448|NCT01544673|"~     Results from previous studies have been inconclusive and the effect of linezolid on cytokines~     remains unclear. This study is designed to evaluate the effect of linezolid on the~     functionality of white blood cells (neutrophils and monocytes) in healthy subjects.~   "
154481|NCT01544244|"~     The primary objective of this study is to demonstrate the superiority of the CGE physical~     therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the~     following after 1 month of physical therapy: the FI2S score including validated measures of~     pain, glenohumeral joint range of motion in the three planes, the ability to perform certain~     everyday activities and the strength of forward elevation measured with a dynamometer.~   "
154424|NCT01544985|"~     INTRODUCTION AND JUSTIFICATION~      The use of sucrose has been well studied for certain procedures in neonatal intensive care~     unit patients and in the newborn nursery settings, particularly for venous blood draws,~     capillary blood tests and circumcision. In these studies, infants receiving oral sucrose~     solutions before procedures cried less and had overall decreased behavioural pain responses~     when compared with those receiving placebo.~      In Emergency Departments (ED), children undergo many painful procedures, such as bladder~     catheterization, capillary blood tests, venipuncture and lumbar puncture. Only two studies~     have examined the effectiveness of sweet solutions as an analgesic in the ED. A randomized~     controlled trial in an emergency setting of sucrose and/or pacifier for infants receiving~     venipuncture conducted by Curtis and al among infants of 0 to 6 months demonstrated a trend~     in reducing pain among the sub-group of infants of 0 to 3 months. However, this study showed~     no difference in pain scales after 3 months of age. Also, in a study examining the effect of~     sucrose during bladder catheterization, the subgroup of infants 1 to 30 days old who received~     a sweet solution showed smaller changes in pain scores, were less likely to cry during~     catheterization and returned to baseline more quickly, in comparison with the placebo group.~     However, among children of 31 to 90 days, there was no statistically significant difference~     in pain scores. In this study, they used a sucrose solution of only 24% and as they said in~     the discussion, it is possible that older infants, who on average received a smaller dose (in~     milligrams per kilogram), were in fact underdosed.~      Finally, the painful procedure chosen for this study is bladder catheterization. Bladder~     catheterizations are frequently performed in the ED in this age group.~      HYPOTHESIS The investigators believe that providing an oral sucrose solution during bladder~     catheterization will decrease pain levels in infants 1 to 3 months of age.~      OBJECTIVES The investigators primary objective is to compare the efficacy an oral 88% sucrose~     solution to a placebo solution in reducing pain as assessed by the FLACC scale in children of~     1 to 3 months during bladder catheterization in the ED. The investigators secondary objective~     is to asses changes in pain levels as per the NIPS score. The investigators will also measure~     variations in heart rate and crying time. All side effects will also be reported.~   "
154425|NCT01544972|"~     The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety~     in relation to serum levels in closure of patent ductus arteriosus in preterm infants.~   "
154426|NCT01544959|"~     The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol~     during general anesthesia for patients undergoing mastectomy will result in less pain and~     less narcotic consumption in the recovery room. The investigators will also verify the impact~     of that substitution on nausea and vomiting, on the time spent in the recovery room and on~     chronic postsurgical pain (3 and 6 months).~      Finally, the investigators will see the impact on breast cancer recurrence 5 years after the~     surgery.~   "
154427|NCT01544946|"~     Background: Early recognition and treatment of pain among children is important for their~     cognitive development and their future response to pain throughout their life. Oral sweet~     solutions have been accepted as effective pain reducing agents for procedures in the neonatal~     population. To date, there have been a limited number of published clinical trials in an~     emergency setting studying this type of intervention among infants undergoing venous puncture~     and bladder catheterization. These studies have reported conflicting results. No previous~     studies have evaluated the utilization of sucrose to manage pain during nasopharyngeal~     aspiration.~      Objective: To compare the efficacy of an oral sucrose solution versus placebo in reducing~     pain in children one to three months of age during nasopharyngeal aspiration in the Emergency~     Department.~   "
154428|NCT01544933|"~     The purpose of this study is to analyse the anatomic influence of the ribs related to the~     incidence and severity of burst spine fractures.~   "
154429|NCT01544920|"~     The primary purpose of this study is to compare the efficacy of two boceprevir~     (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic~     hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.~      The regimens differ in the treatment for participants who achieve undetectable HCV~     ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV)~     4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm~     2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants~     with undetectable HCV RNA at Follow-Up (FU) Week 24.~   "
154430|NCT01544907|"~     A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty~     versus conventional percutaneous transluminal angioplasty balloon for the treatment of~     hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal~     loss and restenosis rates, while prolonging primary and secondary patencies.~   "
154431|NCT01544894|"~     The purpose of this study was to compare compliance and efficacy of raloxifene and strontium~     ranelate in a group of women with postmenopausal osteoporosis.~   "
154432|NCT01544881|"~     This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response~     (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.~   "
154433|NCT01544868|"~     The purpose of this study is to measure resting energy expenditure, total energy expenditure,~     and physical activity in recovering burn children to better understand their relation to~     impaired growth and nutritional status; and to measure whole body and muscle protein turnover~     during recovery from burn injury to understand their impact on body composition and energy~     metabolism. It also aims to look at changes in lean body mass, fat mass, bone mineral density~     and bone mineral content during rehabilitation and during early convalescence.~   "
154434|NCT01544855|"~     Genetics and nutrition both clearly affect the risk of Alzheimer's disease (AD) in the~     elderly. Apolipoprotein E (APOE4) is the most important known genetic risk for AD and is~     prevalent in 20-25% of Canadians, but at present, knowing an individual's ApoE genotype does~     not help the diagnosis, treatment or prevention of AD. Furthermore, fish intake containing~     docosahexaenoic acid (DHA, 22:6 omega-3) and eicosapentaenoic acid (EPA, 20:5 omega-3) may be~     incorporated as a prevention strategy for lowering the risk of AD. However, fish intake seems~     not to protect APOE4 carriers from developing AD. One explanation as to why APOE4 carriers~     may not benefit from fish intake is potentially linked with imbalances in omega-3 fatty acid~     metabolism. The investigators recently reported that after 3g/d of EPA+DHA for 6 weeks,~     increases in the two fatty acids was less for carriers resulting in a significant~     gene-by-diet interaction. ApoE is a component of lipoproteins and ApoE genotypes modulate the~     fasting lipoprotein response to fish-oil supplementation. Therefore, the investigators~     hypothesis is that APOE4 genotype is associated with imbalances in lipoprotein concentrations~     which has the consequence to be associated with imbalances in EPA and DHA transport. The~     investigators will recruit and test 100 healthy young adults since at older ages carriers of~     ApoE4 usually take medication altering their lipoprotein profile. They will receive an EPA +~     DHA supplement for one month. This period was chosen because the 3 class of lipoproteins~     (VLDL, LDL and HDL) have different concentrations in TG, phospholipids and cholesteryl esters~     and to fully investigate lipoprotein fatty acid changes, one month of supplementation is~     needed to change EPA and DHA in all lipid classes. The investigators will monitor the~     distribution of EPA and DHA in the lipoproteins over a one month supplementation with fish~     oil and the investigators will separate the investigators groups by APOE4 carriers and~     non-carriers.~   "
154435|NCT01544842|"~     The purpose of this study is to compare the effectiveness of topical tacrolimus,~     triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).~   "
154459|NCT01544530|"~     The purpose of this study is to assess the feasibility and safety of mild-to-moderate~     hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60~     brain-dead organ donors.~   "
154460|NCT01544517|"~     A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential~     therapy for eradication of H. pylori infection.~   "
154438|NCT01544803|"~     Objectives: This study compares the efficacy of eScreen and Alkoholhjalpen in a three-armed~     randomized controlled design, measuring outcomes in terms of changes in problematic alcohol~     use up to one year after study recruitment. The eScreen brief Internet intervention for~     problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized~     feedback and treatment recommendations as well as an electronic diary. Progress over time is~     shown in diagrams detailing consumption levels. A more extensive Internet intervention for~     problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a~     solution-oriented focus, electronic diary and moderated chat-forum.~      Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are~     randomized into one of three groups: T1, eScreen referral (n=211); T2, Alkoholhjalpen~     referral (n=211); Control group (n=211). Outcomes on alcohol use as well as health-related~     symptoms are assessed after 3, 6 and 12 months.~      The first hypothesis is that all three groups will reduce their alcohol consumption and~     alcohol-related problems at follow-ups compared to the baseline level. The second hypothesis~     is that there will be no differences between participants in the eScreen and the~     Alkoholhjalpen group in reduction of alcohol consumption and alcohol-related problems at~     follow-ups. The third hypothesis is that participants in the eScreen and the Alkoholhjalpen~     group will show a greater reduction in alcohol consumption and alcohol-related problems~     compared to the control group (no intervention) at follow-ups. For a greater understanding of~     the study results possible other interventions received by the study participants for their~     problematic alcohol use during these 12 months of study participation will be investigated.~   "
154439|NCT01544790|"~     This is the first randomized controlled trial designed to compare robot-assisted minimally~     invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical~     treatment for resectable esophageal cancer.~      If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic~     esophagectomy will result in a lower percentage of postoperative complications, lower blood~     loss, shorter hospital stay, but with at least similar oncologic outcomes and better~     postoperative quality of life compared with the open transthoracic esophagectomy (current~     standard).~   "
154440|NCT01544777|"~     To evaluate visual acuity and quality of vision in participants undergoing cataract surgery~     with a Hoya model 751 intra-ocular lens and to compare the visual results to the common~     monofocal lens in use.~   "
154441|NCT01544764|"~     The North Carolina Immunization Branch will evaluate the use of the CDC program to improve~     adolescent vaccination practices (called Assessment, Feedback, Incentives, and eXchanges, or~     AFIX). This evaluation is the first of its kind in the nation and may have a profound impact~     on prevention.~      AFIX has four major components: 1) Assessment of a provider's current immunization practices~     and vaccination levels, 2) Feedback of the assessment results and strategies to improve~     coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and~     resources necessary to facilitate improvement.~      This program will evaluate the effectiveness of AFIX visits on affecting provider practices~     to increase adolescent (age 11-18) immunization. Visits include discussion of that practice's~     immunization rates and strategies for improving rates. The investigators will compare the~     changes, from baseline to 5 months, in immunization for practices receiving virtual visits~     (webinars), in-person visits, and no visits (control group). Thirty practices will be~     randomly assigned to each intervention type. The main outcomes of this study are~     practice-wide uptake rates of several adolescent vaccines (Tdap, HPV, and MCV4) as well as~     pre- and post-AFIX visit surveys focusing on recall tactics utilized by each practice. Data~     will be collected on practices with at least 200 adolescent patients (note: there is no~     patient-level data collected in this study).~   "
154442|NCT01544751|"~     The first line approach to NAFLD is currently based on diet and lifestyle modification. Aim~     of our Unit is to compare the efficacy of two different doses of metformin (1 g/day and 2~     g/day) with atorvastatin (20 mg/day) on amelioration of inflammatory and cardiometabolic~     parameters, ultrasound signs and clinical scores associated with liver fibrosis in~     early-stage NAFLD non-diabetic patients.~   "
154443|NCT01544738|"~     Movement slowness (bradykinesia) is one of the main motor symptoms in Parkinson Disease (PD).~     Several studies have shown that patients with PD exhibit slowness because they are unable to~     modulate, in an optimal way, the velocity of voluntary motor acts not induced by external~     stimulation. Indeed, these patients have difficulties to integrate multi-sensorial~     information, mainly proprioception.~      The investigators investigated changes in shoulder velocity during pointing movements by~     patients with PD after stimulation of soft tissues (aponeurosis) of upper limb muscles. The~     stimulation consisted of manipulating, with a hook (the diacutaneous fibrolysis method), the~     aponeurotic tissues enrobing the heads of the upper limb muscles. This technique has~     previously been shown to decrease passive tension and the tendon reflex response of the~     manipulated muscle group. The investigators hypothesis is that aponeurotic manipulation of~     shoulder muscles therefore creates a modification in the proprioceptive information, which in~     return temporarily decreases the bradykinesia of shoulder movements.~   "
154444|NCT01544725|"~     Using Ketamine for procedural sedation in adults is often uncomfortable for emergency~     physicians because of the significant proportion of patients experimenting recovery~     agitation. The investigators believe that combining propofol to ketamine, the proportion of~     recovery agitation will be significantly lowered.~      The objectives of this double-blinded, randomized controlled trial are to compare the~     proportion of recovery agitation in adults receiving procedural sedation with~     ketamine-propofol versus ketamine alone, and to compare the proportion of other classical~     procedural sedation side-effects and parameters such as respiratory depression, hypotension,~     sedation duration, time of recovery, procedural failures, and levels of satisfaction.~   "
154445|NCT01544712|"~     In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow~     grafting was reported with a reduction of the functional evolution and the necessity of a~     total prosthesis placement in a non-controlled retrospective trial. Based on this experience,~     the investigators would like to start a randomized controlled double blind study on the~     effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of~     stage 3 ON of the femoral head.~   "
154446|NCT01544699|"~     tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to~     improve a variety of functions with superior or inferior limb.~   "
154449|NCT01544660|"~     Our overarching aim is to set up a procedural, analytic and developmental framework to~     establish CT of the central and peripheral skeleton as a clinically useful biomarker for~     skeletal strength in the clinical research and ultimately in the clinical setting. To~     accomplish this, the investigators will develop and validate phantoms and scanning procedures~     to standardize strength and structure measurements between different vQCT scanners and~     develop standardized acquisition, analytical, and quality control techniques for HR-pQCT with~     an emphasis on optimization for multi-center studies.~   "
154450|NCT01544647|"~     Non-pharmacological treatments are recommended for the management of knee osteoarthritis~     (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving~     symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known~     about the advantage of one modality of thermal therapy over another.~      The main objective of the study is to compare the number of patients achieving a composite~     response criteria associating the minimal clinically important improvement at 6 months,~     defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised~     Western Ontario and McMaster Universities osteoarthritis index function score and no knee~     surgery in 2 spa therapy protocols (a usual protocol and an active protocol) in knee~     osteoarthritis.~      The secondary objectives are:~        1. To compare the efficacy of the 2 protocols at 3 months.~        2. To determine the evolution of quality of life and medical care consumption~        3. To describe postural abnormalities~        4. To determine predictive factors to a favourable response at 3 and 6 months~   "
154451|NCT01544634|"~     Current asthma medicines include inhalers. A common type of inhaler is called a~     'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the~     airway causing it to widen. Although these drugs are useful short term, long term use can~     make asthma worse in some people.~      'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in~     patients with asthma. Beta-blockers cause problems in asthmatics in the short term, including~     severe asthma attacks.~      The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer'~     medication. These work by dampening down the inflammation in the lungs that occurs in asthma.~      New research has suggested that longer term use of beta-blockers can also reduce airway~     inflammation which may improve asthma control. This research was done in asthmatic patients~     who didn't need inhaled steroids to control their asthma. At the moment the investigators are~     studying to see if there is a benefit of beta-blocker use for asthma over and above~     asthmatics own usual doses of inhaled steroids.~      In this study, the investigators will be trying to find out if adding a beta blocker to a~     smaller dose of steroid inhaler has the same effect on asthma control as just using a higher~     dose of steroid inhaler by itself.~   "
154452|NCT01544621|"~     Real life smoking cessation rates after 24 weeks non-intervention design. Approximately 40~     General Practice (GP) centers with 800 smokers will participate.~   "
154453|NCT01544608|"~     The primary objective of this Non- Interventional Study (NIS) is to describe the use of~     atypical antipsychotics in subjects with Schizophrenia during the hospitalisation due to~     acute psychotic episode by evaluation of drug, dose and mode of administration of the~     medication.~   "
154454|NCT01544595|"~     This is an extension study of secukinumab prefilled syringes in subjects with moderate to~     severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with~     secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies~     (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III~     studies) will be eligible to join this extension study. This extension study is planned to~     collect an additional 2 years of long-term efficacy, safety, and tolerability data of~     secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in~     subjects showing at least partial response to secukinumab and completing treatment period on~     secukinumab in previous phase III studies. In this extension study, the prefilled syringe~     (PFS) liquid formulation of secukinumab will be used.~   "
154455|NCT01544582|"~     This is an observational prospective follow-up study to assess the utilization of boceprevir~     and the management of pre-specified health outcomes of interest (HOIs) under conditions of~     routine clinical care in participants with chronic hepatitis C (CHC) genotype 1.~      As an observational prospective study, this study is not intended to change the~     participant/physician relationship, nor influence the physician's drug prescription or~     therapeutic management of the participant. No individual administration of any therapeutic or~     prophylactic agent is assigned in this protocol, and there are no procedures required as part~     of this protocol. Physician choice of the drug used to treat the participant is based on~     clinical judgment alone.~   "
154456|NCT01544569|"~     RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory~     may help doctor learn more about changes that occur in DNA and identify genes related to~     cancer.~      PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid~     tumors.~   "
154457|NCT01544556|"~     Abdominoplasty is one of the most commonly performed procedures in plastic surgery. The~     appearance of the scar is a major factor contributing to the aesthetic outcome of the~     procedure and depends largely on the technique of wound closure. The investigators routinely~     used resorbable subcutaneous sutures and resorbable intracutaneous sutures for this closure.~     To overcome the potential detrimental effects of sutures in skin closure, surgical adhesives~     were introduced as a new technology. The new PrineoTM wound closure system was created to~     combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a~     self-adhering mesh to make closure of long skin incisions even more safe and reliable.~     PrineoTM has the potential to offer a patient several benefits over traditional wound closure~     with sutures.A patient treated with Prineo™ can shower immediately following a procedure~     because the product forms a watertight barrier over the incision. PrineoTM can be easily~     removed, often with less pain than is sometimes associated with suture removal, after the~     natural wound healing process is complete (approximately 12 to 25 days). Other benefits are~     that it forms a microbial barrier and provides even distribution of tension across the length~     of the incision to ensure wound edge approximation throughout the wound healing process.~     Furthermore, it reduces subcuticular closure time as compared to subcuticular suturing.~      However, these potential advantages have not been proven until now, as the methods used to~     assess the aesthetic outcome were not reproducible in most assessments, and none of these~     studies assessed patient satisfaction.1-3 Moreover, none was performed in a plastic surgical~     patient population. For these reasons, the investigators prospectively studied the results of~     wound closure after abdominoplasty with randomized use of PrineoTM and conventional suturing~     to assess the possible difference in outcome between these two methods.~   "
154458|NCT01544543|"~     VESALIO is a pilot study aimed at evaluating the feasibility and reliability (time stability~     and interobserver reliability) of healthcare quality standards in chronic obstructive~     pulmonary disease (COPD) recently outlined by SEPAR (Spanish Pneumology and Thoracic Surgery~     Society), and at establishing the foundation for a future validation (construct and criterion~     validation) of the aforementioned standards.~   "
154462|NCT01544491|"~     The purpose of this study is to determine if everolimus combined with reduced exposure CNI~     (TAC) is efficacious and safe and will support corticosteroid elimination compared to a~     standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation.~     An additional purpose of the study is to assess the effect of the combination of EVR and~     reduced exposure CNI (TAC) on renal function.~      This study is part of the requirements of the Paediatric Investigational Plan approved by~     Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and~     is intended to support the indication of everolimus in the prevention of acute rejection in~     paediatric recipients of a renal transplant.~   "
154463|NCT01544478|"~     This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6,~     11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial~     neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese~     women.~   "
154464|NCT01544465|"~     The purpose of this study is to examine the ability of a structured physical activity program~     to improve sleep quality and daytime sleepiness in patients with Parkinson's disease.~   "
154465|NCT01544452|"~     Patients with rectal cancer undergo MRI of the rectum, CT of the thorax and abdomen (or~     thorax x-ray and ultrasonic liver evaluation) and colonoscopy as a total diagnostic~     evaluation before surgery. MR colonography have been shown to have high sensitivity and~     specificity for larger polyps and cancer and MRI of the liver have been shown to have similar~     or higher sensitivity than CT of the liver for metastasis. Since patients already undergo MR~     of the rectum, the investigators have proposed a total diagnostic evaluation with MRI of the~     liver, abdomen, colonography and rectum in one session (minus thorax evaluation) instead of~     two or three different methods of evaluation. The investigators hypothesis is that the total~     MR evaluation is equal or superior to the existing preoperative evaluation regarding the~     diagnosis of synchronous cancers and liver metastasis and regarding cost-benefit for the~     total diagnostic evaluation.~   "
154466|NCT01544439|"~     The aim of this study was to evaluate the effectiveness of the splint occlusal associated~     with counseling in reducing pain in patients with temporomandibular disorders, under the~     assumption that the occlusal appliance offers the highest rates of improvement than their~     placebo.~   "
154467|NCT01544426|"~     Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI)~     cycles , in cases of repeated implantation failure. It is found that it will improve the~     implantation rate.~   "
154468|NCT01544413|"~     Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric~     cancer is less invasive method which can increase quality of life. Multicenter phase III~     trial is requred to validate this method. In this study all items which are necessary for~     laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated~     the performance completement.~   "
154469|NCT01544400|"~     Athletes in particular elite athletes have obsessional food and body concerns, in bond with a~     worship of the performance more and more invading, which lead to clinical and subclinical~     eating disorders. These eating disorders differ according to the disciplines and are~     difficult to diagnose in athletes because there are insufficiently described.~      Our aim at estimating the frequency of eating disorders in athletes and describing eating~     disorders by means of somatic, dietetic and psychological evaluations.~   "
154470|NCT01544387|"~     The objective of this study is to determine, through a randomized clinical trial, whether bed~     rest is helpful for the management of pregnancies complicated by preterm premature rupture of~     membranes (PPROM).~   "
154471|NCT01544374|"~     Breast cancer is the second most common cause of cancer death in women. Black women are less~     likely than white women to develop breast cancer but, they are more likely to die of the~     disease. Some of this survival discrepancy is likely due to underuse of adjuvant therapies~     proven to increase survival. Breast cancer treatment often requires coordination among~     surgeons, pathologists, primary care physicians, medical and radiation oncologists. In NYC,~     black and Hispanic women who accessed care and underwent surgical treatment of their breast~     cancer were twice as likely as whites to experience underuse of adjuvant treatment.~     Disturbingly, 1/3 of these underuse cases were episodes in which the surgeon recommended~     treatment, the patient did not refuse and yet, care did not ensue. Underuse in such~     circumstances is attributable to system failures than to specific provider or patient~     factors.~      In this proposed randomized controlled trial, the investigators aim to test the effectiveness~     of a Tracking and Feedback (T&F) registry innovation to increase rates of completed oncology~     consultation and reduce both underuse of needed adjuvant therapy and racial disparities in~     receipt of these treatments. The investigators also aim to assess the feasibility of~     implementing a T&F Registry in these high-risk hospitals by evaluating implementation~     effectiveness for that innovation. The investigators have recruited 10 hospitals that serve~     large proportions of minority women with breast cancer. The investigators will randomize~     hospitals and aim to recruit 354 women with a new breast cancer, 177 per intervention arm.~     The investigators choose these high risk hospitals because they serve predominantly~     minority populations, and such hospitals have higher rates of the system failure cause of~     underuse, and particularly, the type of underuse targeted by our Tracking and Feedback~     Registry.~   "
154472|NCT01544361|"~     This is a Phase 1 study to evaluate the safety and tolerability of single ascending~     intravenous doses of MEDI7814 in healthy adult subjects.~   "
154473|NCT01544348|"~     Phase 1 study to evaluate the safety of MEDI4212.~   "
154474|NCT01544335|"~     The purpose of this study is to determine whether measuring the fluid in your arms using~     Bioimpedance Spectroscopy is as effective at detecting and monitoring lymphedema as~     measurements with the Perometer. The investigators will also evaluate any symptoms you may~     experience in your arms during and after treatment for breast cancer with a questionnaire.~   "
154475|NCT01544322|"~     The purpose of this study is to determine the tolerability of ME-344, find the maximum~     tolerated dose, and the safety profile in patients with refractory solid tumors.~   "
154476|NCT01544309|"~     The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid~     lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes~     mellitus.~   "
154477|NCT01544296|"~     This is a placebo-controlled, double blind, crossover study to evaluate the efficacy and~     safety of KHK6188 in postherpetic neuralgia when administered orally for 2 weeks.~   "
154478|NCT01544283|"~     Objective:~      This purpose of this pilot study is to explore the potential usefulness of Synera for the~     treatment of pain associated with shoulder impingement syndrome.~   "
154479|NCT01544270|"~     The study aims to investigate the role of dietary factors in chronically stressed subjects.~     Previous studies have shown that milk proteins, B vitamins and probiotics may influence on~     subjective well-being in stressed subjects.~   "
154509|NCT01543880|"~     This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in~     adults treated with somatropin (Norditropin®).~   "
154482|NCT01544231|"~     This research project consists of a prospective diagnostic study conducted on patients with~     clinical suspicion of rhabdomyolysis admitted to the emergency rooms of the University~     Hospitals of Nimes, Montpellier, Paris, Nice and Toulon Inter Army Hospital. The main~     objective of this study is to determine whether the plasma level of Neutrophil Gelatinase~     Associated Lipocalin (NGAL) may be retained as a predictor of acute renal failure (ARF)~     occurring within 48 hours after admission for rhabdomyolysis.~   "
154483|NCT01544218|"~     Alcohol use is a serious health threat to the 26% youth in the US with chronic medical~     conditions. While alcohol use can significantly impact an underlying illness and its~     safe/effective management, medical specialists rarely screen their adolescent patients for~     alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18~     year old youth with chronic medical conditions. Comprehensive assessment information will be~     collected and analyzed to describe relationships between youth alcohol use, other substance~     use, and chronic disease outcomes and findings integrated into the validated screen as~     actionable clinician guidance and health advice.~   "
154484|NCT01544205|"~     The purpose of the study is to investigate whether neurofeedback delivered via functional~     magnetic resonance imaging signals can be used to train depressed patients to self-regulate~     emotion networks and whether this improves clinical symptoms.~   "
154485|NCT01544192|"~     Background: The significance of retinal ganglion cell protection in the glaucoma led the view~     that, glaucomatous optical neuropathy can also be considered as a pathology of central~     nervous system. It is known that α−tocopherol and Gingko Biloba have specific neuroprotective~     and vasoregulatory activities, in addition to antioxidant effects. In this study, the~     investigators compared early neuroprotective effects of α−tocopherol and GB with each other~     as well as control and a strong antioxidant formulation in patients with glaucoma.~      Methods: In this non-randomized control trial, 120 eyes of 60 patients with glaucoma were~     enrolled into the study and divided into 4 groups, each consisting of 30 eyes. Unlike the~     controls, patients in the 3 antioxidant groups received α−tocopherol, Gingko Biloba and a~     strong antioxidant formula for 3 months. Central vision field and MD, PSD and OCT as well as~     thickness of retinal nerve fiber layer, ganglion cell counts and c/d ratios were recorded.~     The data were compared statistically.~   "
154486|NCT01544179|"~     The purpose of this study is to assess the efficacy and safety of gefitinib in patients who~     have progressed on first line gefitinib, comparing continuing gefitinib in addition to~     cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed~     combination chemotherapy alone.~   "
154487|NCT01544166|"~     The main purpose of this study is to collect data on the way gadobutrol is taken into, moves~     around, and is eliminated from, the body of children aged 0 to less than 2 years. The study~     will also evaluate safety and tolerability, and efficacy of gadobutrol.~      A maximum total amount of approximately 5 ml of blood will be needed for these analyses which~     will be drawn within 2-3 days.~      Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI),~     potentially allowing better visibility of tissues in the body. Children aged under 2 years~     scheduled for a routine contrast-enhanced MRI examination of any body region may take part in~     this study, in which case they will receive gadobutrol as contrast agent intravenously at the~     standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal~     insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate <80% of age~     adjusted normal value calculated based on the Schwartz formula) will be included in the~     trial.~      The duration of this study as a whole is around 1 year and the total number of children to be~     enrolled is 50. A child will be expected to take part in the study for around 7 days.~   "
154488|NCT01544153|"~     This study will compare the efficacy of an interactive, evidence-based smoking cessation~     website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social~     network (SN) protocol designed to integrate participants into the online community, and 2)~     access to a 4-week supply of free NRT.~   "
154489|NCT01544140|"~     The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of~     Midazolam administered alone and in combination with Vandetanib.~   "
154490|NCT01544127|"~     The purpose of study is to test the efficacy of an adaptation of Motivational Interviewing to~     Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically~     hospitalized Veterans at high risk for suicide.~   "
154491|NCT01544114|"~     A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.~   "
154492|NCT01544101|"~     The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a~     low-fat, vegan diet improves pain and other subjective symptoms more effectively than a~     control supplement or a placebo. The principal measure is pain as measured by Visual Analog~     Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,~     respectively. The study duration is 36 weeks.~   "
154493|NCT01544088|"~     The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT)~     is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary~     diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group~     treatment condition. Both treatments will consist of 14, weekly sessions. Assessment of PTSD~     and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and~     3-, 6-, - and 12-month follow-up.~   "
154494|NCT01544075|"~     With the present study the investigators wish to examine if reconceptualisation of pain, by~     educating chronic whiplash-associated disorders (CWAD) patients on the neurophysiology of~     pain, in combination with psychologic innoculation is able to influence maladaptive (pain)~     cognitions, pain (inhibition) and movement performance, and reduce symptoms.~   "
154495|NCT01544062|"~     Patients undergoing cardiac surgery experience significant postoperative pain, which may~     impact postoperative outcomes. The aim of this single center, double-blind, randomized,~     placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly~     decrease 24 hour postoperative opioid consumption.~   "
154496|NCT01544049|"~     The purpose of this study is to better understand why women choose to have their fallopian~     tubes removed as a method for ovarian cancer prevention. This will be done through a paper~     questionnaire and phone interviews. The investigators hope to gain information that will~     allow us to better counsel women about ovarian cancer prevention.~   "
154497|NCT01544036|"~     Contrast induced nephropathy (CN) is a common cause of acute kidney injury and is associated~     with increased morbidity and mortality and healthcare cost. Iodinated contrast media (ICM)~     induce kidney injury through vasoconstriction and ischemia as well as direct tubular~     toxicity. Older subjects, individuals with preexisting kidney disease, diabetes, hypotension,~     and those exposed to higher volumes of ICM are at higher risks for CN. Within the last~     several years, multiple strategies have been used in clinical studies to reduce the risk of~     CN in high risk individuals with inconsistent results. In general, it is agreed that volume~     expansion is effective in reducing the risk. However, no study has looked at changes in renal~     blood flow (RBF) in response to volume expansion or after exposure to ICM to investigate its~     relationship with occurrence of CN.~      In this proposal, up to 125 individuals with preexisting kidney disease as evidenced by an~     estimated glomerular filtration rate (eGFR) between 30 - 60 ml/min/1.73 m2 and up to 25~     individuals with normal renal function (total of up to 150 individuals) who are scheduled for~     coronary angiography will be studied. Each individual will have serial measurements of RBF;~     at baseline, after volume expansion with normal saline, and after exposure to ICM, using the~     novel technique of contrast enhanced ultrasound (CEU). The investigators will investigate the~     utility of monitoring RBF with CEU in predicting the occurrence of CN (a rise of > 0.3 mg/dL~     or 25% in baseline serum creatinine 48 hours after exposure to ICM) after adjusting for other~     known risk factors in the group of subjects with reduced GFR. The investigators will also~     examine the correlation between RBF changes and other urinary and serum biomarkers of kidney~     injury in this group. Up to 25 individuals with a normal kidney function will be studied in a~     separate part of the study in which the accuracy of CEU based measurements of RBF will be~     compared to the RBF and blood flow velocity obtained simultaneously using a Doppler flow~     probe placed directly inside the main renal artery during coronary angiogram procedure. Total~     to enroll = 150.~   "
154498|NCT01544023|"~     A new approach for single stage implant based breast reconstruction (BR) is the use of a~     titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).~     These TCPM have a good biocompatibility and can be used in a similar way as ADM. This study~     addresses indications, limitations and complications of TCPM in implant based breast~     reconstruction.~   "
154499|NCT01544010|"~     This study explored optimal tailoring strategies for population tobacco cessation in 4~     treatment groups and a control group over 24 months. Transtheoretical model (TTM) tailored~     feedback on all 14 variables has been found to be a robust population cessation strategy~     across studies. This proposal sought to find a subset of these variables that is optimal for~     tailoring, both minimizing response burden while maximizing effectiveness. Addiction~     variables have been demonstrated to predict smoking outcomes across studies as well, so we~     will integrate tailored feedback using TTM and addiction variables into an enhanced tailoring~     group. Optimally tailored feedback that both helps unmotivated smokers reduce their addiction~     and helps motivated smokers quit could lead to a breakthrough in population cessation.~   "
154500|NCT01543997|"~     The purpose of this study is to investigate clinical benefits of a novel sleep-focused~     mind-body program on Gulf War Illness (GWI) symptoms.~   "
154501|NCT01543984|"~     The purpose of this study is to test the effect of Tailored Physical Activity on the number~     of sick-days.~      The hypothesis is that Tailored Physical Activity is superior in efficacy on sick-days.~   "
154502|NCT01543971|"~     This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily~     injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together.~      The aim of the study is to determine the safety of the TXA127 alone and in combination with~     Neupogen, and to determine whether the use of TXA127 alone or in combination with Neupogen~     enhances peripheral blood stem cell (CD34+)mobilization.~   "
154503|NCT01543958|"~     HIV-infected people can have an increase in inflammation in their body organs, even after~     taking anti-HIV medicines.~      Sevelamer carbonate is used to bind phosphate in dialysis patients. It can also bind~     endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Sevelamer~     carbonate decreases the inflammation endotoxin causes in dialysis patients.~      A5296 is a phase II, single-arm study to evaluate the effect of 8 weeks of sevelamer~     carbonate administration on markers of microbial translocation and T-cell activation in the~     blood in chronically HIV-infected subjects not receiving ART.~   "
154504|NCT01543945|"~     The purpose of this study is to compare the incidence of Postoperative nausea and vomiting~     between the intervention group who received multimodal antiemetic management and the control~     group who did not get this protocol.~   "
154505|NCT01543932|"~     Dual antiplatelet therapy with Aspirin and Clopidogrel for at least one year is essential in~     patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention~     (PCI) with drug eluting stent(s) implantation. Interindividual variability in platelet~     response to Clopidogrel has been reported, with several mechanisms (intrinsic high platelet~     reactivity [PR], variability of the drug metabolism, and various drug interactions) being~     implicated for high post-Clopidogrel treatment PR. The investigators aim to perform a~     prospective, single-center, investigator-initiated, randomized, study to compare platelet~     inhibition by Prasugrel 10 mg/day, Ticagrelor (90 mg twice daily) and high-dose 150 mg/day~     Clopidogrel in patients with High on-treatment platelet reactivity (HTPR) with standard dose~     of Clopidogrel. Patients with HTPR (defined as area under curve-AUC ≥ 450 or > 45 Unit) and~     with loss-of-function allele CYP2C19*2 will be enrolled in the study and will be randomized~     (Day 0) in a 1:1:1 ratio, to either Clopidogrel 150 mg a day or Prasugrel 10 mg a day or~     Ticagrelor (90 mg twice daily) until Day-15 and-30 post randomization.~   "
154506|NCT01543919|"~     PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is~     associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to~     patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety~     and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)~   "
154507|NCT01543906|"~     The purpose of this study is:~        -  To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in~          RP subjects with an autosomal dominant mutation in RPE65.~        -  To evaluate duration of visual function improvement (if observed) in RP subjects with an~          autosomal dominant mutation in RPE65 after 7-day treatment with oral QLT091001.~        -  To evaluate the safety of oral QLT091001 administered once daily for 7 days in RP~          subjects with an autosomal dominant mutation in RPE65.~   "
154508|NCT01543893|"~     Resistance training is widely used in training and rehabilitation. During recent years~     elastic resistance training has become increasingly popular for preventing or relieving~     neck/shoulder/arm pain among sedentary employees. While most research studies documenting~     positive effects of such interventions have used training instructors, most training in~     practice does not use an instructor but rather depends on information from other sources such~     as the internet. Here the investigators examine - in a outcome assessor blinded randomized~     controlled trial - the effect of 2 weeks elastic resistance training for the~     neck/shoulder/arm with personal versus video instruction on technical execution.~   "
154512|NCT01543841|"~     Tie-2 expressing monocytes (TEMs) are a specific type of blood cell that are present in~     healthy individuals and in people with cancer. These cells may play a role in the growth of~     blood vessels (veins/arteries), and may be particularly important in the growth of blood~     vessels that supply tumours. Understanding how these cells work may therefore help~     researchers to develop cancer treatments that starve tumors of their blood supply.~      This research study involves an analysis of the behaviour of blood cells in response to~     different drugs in a test tube. The goal is to develop tests that can then be used to monitor~     patients treated with drugs that target blood vessel growth.~   "
154513|NCT01543828|"~     This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in~     moderate-severe COPD patients with breathing symptoms to assess time to patient's perception~     of onset of effect.~   "
154514|NCT01543815|"~     The WELL-ME study is a three-arm randomized controlled clinical trial (RCT). The aim of this~     RCT is to compare the effectiveness of the Well Being Web Based Therapy (WBT-Web) with the~     gold standard CBT (Cognitive Behavior Therapy) and standard clinical procedure of patients'~     management (CM) for psychological distress and promotion of healthy behaviors in Cardiac~     Patients.~   "
154515|NCT01543802|"~     The purpose of this study is to examine if a short-term treatment with pazopanib, an oral~     drug inhibiting the growth of blood vessel, can reduce the metabolism of soft-tissue sarcomas~     and thus facilitate their resection when given prior to surgery. Moreover, the study assesses~     the prognostic and predictive value of several new biomarkers (endothelial progenitor cells,~     soluble vascular epithelial growth factor),~   "
154516|NCT01543789|"~     The use of mesh in the repair of umbilical hernias is a gold standard. The best location of~     the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity~     (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in~     contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of~     polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory~     ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and~     subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the~     surgery.~      This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene~     for preperitoneal use), will be used in this multicentric trial, to evaluate the best~     procedure in terms of efficacy, safety and postoperative complications.~   "
154517|NCT01543776|"~     This randomized phase II trial studies the best way to give abiraterone acetate in treating~     patients with castration-resistant prostate cancer. Abiraterone acetate is effective in~     treating castrate resistant prostate cancer and is taken in the fasting state. However, the~     body's absorption of abiraterone is increased with food intake. This study will test the~     whether a lower dose of abiraterone taken with food has a similar effect on prostate specific~     antigen (PSA) compared to full dose taken fasting.~   "
154518|NCT01543763|"~     This is a open-label non-randomized, dose escalation and expansion Phase Ia/b study to~     determine the safety, tolerability and maximum tolerated dose (MTD) of pazopanib in~     combination with PCI-24781 in patients with advanced solid tumors.~   "
154519|NCT01543750|"~     Episodic ataxia type 2 (EA2) is a rare familial neurological condition characterized by~     debilitating episodes of vertigo and imbalance. Since the serendipitous discovery of dramatic~     response of EA2 to acetazolamide, acetazolamide has been the first-line treatment for EA2.~     Yet, for those patients who do not respond to or cannot tolerate acetazolamide, there is no~     alternative treatment. The purpose of this randomized trial is to test whether~     4-aminopyridine may reduce the ataxia episodes in EA2 as an alternative to acetazolamide.~     Funding Source - FDA OOPD~   "
154520|NCT01543737|"~     The purpose of this study is to assess whether a single injection hyaluronic acid (HA)~     product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of~     effectiveness in reducing pain when walking in patients suffering from symptomatic~     tibiofemoral osteoarthritis of the knee.~   "
154521|NCT01543724|"~     The investigators will assess Li-induced gray matter volume changes with regard to the~     endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more~     attributable to neurotrophic and neuroprotective characteristics of Li, which were closely~     related to the inhibition of apoptotic activity of GSK3beta.~   "
154522|NCT01543711|"~     Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently~     occurring late effects of breast cancer treatment. The investigators have previously~     published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006.~     Very few studies have examined how these late effects change in time. The aim of this study~     is to examine in a well defined patient population any change in the prevalence of persistent~     pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor~     profile.~   "
154523|NCT01543698|"~     This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate~     the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple~     combination of LGX818 and MEK162 and LEE011, followed each independently by a Phase II part~     to assess the clinical efficacy and to further assess the safety of the combinations in~     selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous~     schedule. Oral LEE011 will be administered once daily on a three weeks on, one week off~     schedule. Patients will be treated until progression of disease, unacceptable toxicity~     develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as 28~     days. The dose escalation parts of the trial will be conducted in adult patients with BRAF~     V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for the~     dual combination and at least 12 patients for the triple combination. The dose escalation~     will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D~     declaration, patients will be enrolled in three Phase II arms for the dual combination and~     one Phase II arm for the triple combination. All patients will be followed for 30 days for~     safety assessments after study drugs discontinuation. All patients enrolled in the Phase II~     part of the study will be followed for survival.~   "
154524|NCT01543685|"~     The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and~     effective for the treatment of postoperative bunionectomy pain.~   "
154525|NCT01543672|"~     Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer~     patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation~     study.~   "
154526|NCT01543659|"~     The purpose of this study is to define the safety and accuracy of 89Zr-DFO-huJ591 PET scans.~     By improving our ability to find cancer cells, the investigators hope to be able to improve~     treatment for patients in the future.~      The study doctors want to determine whether a new kind of scan, called a 89Zr-DFO-huJ591 PET~     scan, can specifically see prostate cancer that has spread to other parts of the body,~     especially the bones. The study doctors will also look at how the 89Zr-DFO-huJ591 reacts with~     the body and how long it stays in the body. The investigators will also ask the patient to~     have a biopsy performed. The study doctors will compare the findings the investigators see on~     the scans with findings on the optional tissue biopsy. Finally, the investigators will~     compare the pictures from a 89Zr-DFO-huJ591 PET scan with those of a standard PET scan~     (called FDG PET) and standard CT scans or magnetic resonance (MRI) scans or bone scans,~     depending on which standard scans the doctor has ordered.~      PET scanning uses a small amount of radiation attached to a molecule that is taken up by the~     cancer. In this trial, the patient will undergo two types of PET scans. One uses FDG. FDG is~     a standard tracer for PET scans. The patient will also undergo another type of PET scan that~     is experimental. This experimental PET uses a radioactive protein called J591. The radiation~     source is a type of metal called zirconium-89 (89Zr). The whole tracer, J591 plus the 89Zr,~     is abbreviated as 89Zr-DFO-huJ591. This tracer is what is being studied. The tracer used in a~     scan should find where the cancer is in the body.~   "
154527|NCT01543646|"~     The RIAL study aims to investigate whether non-invasive measurement of liver fat, iron~     content and fibrosis are as accurate as liver biopsy specimens in determining if patients~     have non-alcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH), or other suspected~     liver disease.~      Currently, the gold-standard for the diagnosis and staging of liver disease is a liver~     biopsy.~      In this study, consecutive patients will be offered a multiparametric MR scan to assess their~     liver while they await a liver biopsy.~      Study time-frame: The scan will be performed in the 6-week period before their biopsy, and~     results will be compared to biopsy findings. results will be presented at the end of the~     study when MR data outcomes are compared to gold-standard biopsy dat. Participants will only~     have to attend one study visit to participate - there will be no patient follow-up.~   "
154528|NCT01543633|"~     The purpose of this study is to investigate how the commonly used anesthetic drug propofol~     works in the brain to produce loss of consciousness. While under general anesthesia your~     brain waves will be measured using electroencephalogram (EEG). On a separate day, the~     patient's brain will be imaged using magnetic resonance imaging (MRI).~   "
154529|NCT01543620|"~     The project is designed to test new biomarkers that are more sensitive than the current~     standard in detecting injury to the proximal kidney tubule and will establish better criteria~     for when kidney safety concerns may halt further testing of a drug in humans.~   "
154530|NCT01543607|"~     Patients with malignant bile duct stenosis have poor prognosis and most of the patients are~     not good candidate for surgery at the time of diagnosis. Placement of the stent is the~     palliative care for these patients. However over 50% of the stents get blocked within 6-8~     months. Use of the radiofrequency ablation before the stent placement may improve stent~     patency. Heat will be applied to the bile duct in order to open the blockage and prevent the~     re-growth of tissue into the stent. The investigators are looking to see how safe and~     feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct~     stenosis.~   "
154531|NCT01543594|"~     The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a~     fundamental discovery to treat rheumatic patients whose disease appears to be refractory to~     conventional therapy. These biologic drugs have been registered for human therapy from a few~     years, thereby the investigators miss long-term data for safety and efficacy. Aim of this~     study is to register all the clinical data of patients with rheumatoid arthritis and~     spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term~     safety and efficacy in the real life.~   "
154532|NCT01543581|"~     The primary objectives of this study are to assess, using Mohs micrographic surgery (MMS) at~     the end of treatment, the efficacy (primary) and safety (secondary) of vismodegib compared to~     placebo in the oral adjunctive pre surgical treatment of basal cell carcinoma. A secondary~     objective is to assess how often and in what types of lesions does pre surgical treatment~     with vismodegib result in complete eradication of the tumor.~   "
154533|NCT01543568|"~     50 Patients with recalcitrant exudative age-related macular degeneration with a history of~     retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and~     subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of~     ranibizumab.~   "
154534|NCT01543555|"~     Patients submitted to noncardiac surgeries are at increased risk of serious cardiovascular~     complications. Statins have shown to lower cholesterol levels and reduce cardiovascular~     events in other scenarios. The objective of this study is to explore the effects of~     atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal~     Myocardial Injury after Noncardiac Surgery (MINS), or stroke among patients who undergo~     noncardiac surgery.~   "
154535|NCT01543542|"~     Helical tomotherapy is a novel radiation treatment machine that combines two existing~     technologies: spiral radiotherapy treatments combined with simultaneous computed tomotherapy~     imaging of the body. This new machine can potentially allow radiation treatments to be~     focused more precisely, and delivered more accurately than with existing radiation machines.~     In this study, helical tomotherapy will be used to provide radiation treatments (whole brain~     radiotherapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to~     the brain. In addition, the individual spots of cancer (metastases) in the brain will be~     treated to a higher dose (approximately 2 times higher) than the dose to the whole brain. The~     purpose of this study is to determine the effectiveness of whole brain radiation with lesion~     boosting with the helical tomotherapy machine.~   "
154536|NCT01543529|"~     This single-center, randomized, double-blind, four-period crossover study will investigate~     the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy~     volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose~     of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and~     alcohol, and placebo to RO4917838 and non-alcoholic drink.~   "
166392|NCT01387789|"~     An observational, non-interventional study on social, economic and quality-of-life outcomes~     of Adalimumab use in participants with moderate to severe active Rheumatoid Arthritis.~   "
154537|NCT01543516|"~     The aim of this case-control study is the comparison of the cell distribution in induced~     sputum in young adults with asthma and in healthy controls.~      The study consists of two visits. At both visits subjects are asked to perform a lung~     function test (body plethysmography) and levels of exhaled nitric oxide (eNO) are measured.~     At the first visit a blood sample is drawn to determine the inflammatory and allergic status~     of the subjects and the sputum is induced by an ultrasonic nebulizer. At the second visit~     another sputum sample is induced by a nozzle nebulizer. The cell distribution will be~     evaluated in both sputum samples.~   "
154538|NCT01543503|"~     This prospective, multi-center, observational study will assess the efficacy and safety of~     treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab)~     as the first biologic therapy. Data will be collected for 52 weeks.~   "
154539|NCT01543490|"~     The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305~     (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active,~     symptomatic Blepharitis.~   "
154540|NCT01543477|"~     The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA),~     neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with~     Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The~     other key objective of this study is to obtain information on adverse drug reactions (ADR)~     associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation~     and data on long term use.~   "
154541|NCT01543464|"~     The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance~     the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.~   "
154542|NCT01543451|"~     The main objective of this study will be to obtain data on the efficacy of elsiglutide in~     preventing Chemotherapy Induced Diarrhea (CID) in patients with colorectal cancer receiving~     5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.~   "
154543|NCT01543438|"~     The goal of this project is to develop the content and delivery platform that electronically~     distributes mobile video discharge education for underserved populations and to demonstrate~     utilization, satisfaction, and improved health outcomes.~   "
154544|NCT01543425|"~     Chronic pain is often associated with a chronic stress and HHSG axis plays a pivotal role in~     maintaining homeostasis. The literature reports that pain in patients treated with opioids,~     significant changes are taking place in this axis with a collapse in hormone concentrations~     that are correlated with the decline on tests of quality of life and psychological testing.~     The investigators hypothesis is that this endocrinopathy could also be present in patients~     treated for neuropathic pain with other drug classes as opiates (antidepressants,~     antiepileptics), and may explain, at least in part, the impairement of the quality of life of~     these patients.~   "
154545|NCT01543412|"~     No validated second-line chemotherapy for the treatment of locally advanced/metastatic~     pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or~     Oxaliplatin)-based regimen.~      Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was~     reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI)~     which could be useful even as second-line chemotherapy.~      An exploratory study in this setting seem warranted.~   "
154546|NCT01543399|"~     The interruption of the secretion of sex steroids occurring during menopause, causes a change~     in vascular pattern at various levels. As a result, several agencies have side effects that~     interfere with women's health. The use of hormone replacement therapy has contributed to the~     improvement in these effects. In previous studies the investigators showed the effect of sex~     steroids in premenopausal women in the conjugated equine estrogens, medroxyprogesterone~     acetate and tibolone in menopausal women, on the central retinal arteries. The aim of this~     study is to evaluate the effects of Tibolone in Flow-Mediated Dilatation of the brachial~     artery.~   "
154547|NCT01543386|"~     The aim of this study is to determine if an oral loading-dose of curcumin can improve~     vascular endothelium reactivity in patients with moderate cardiovascular risk~   "
154548|NCT01543373|"~     The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting~     Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent~     (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence~     Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total~     Stent Struts Per Cross Section) score ≤ 0.3.~   "
154549|NCT01543360|"~     The main objective of this study is to compare the rate of successful establishment of a~     central venous catheter in the first two attempts of ultrasound-guided puncture between two~     techniques: (1) a subclavian technique versus (2) an axillary technique.~   "
154550|NCT01543347|"~     This study is aimed at demonstrating the efficacy of temocillin in the treatment of~     complicated Urinary Tract Infection (UTI) due to confirmed Extended Spectrum Beta-Lactamases~     (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom.~   "
154551|NCT01543334|"~     The primary objective of the DALI study is to compare antibiotic concentrations in patient~     blood samples with bacteriological objectives associated with maximum bactericidal activity.~     The antibiotics studied are certain lactams and glycopeptides.~   "
154579|NCT01542957|"~     The purpose of this study is to determine the efficacy of a brief psychological intervention~     focused on the personal dilemmas identified for each depressive patient. For that, this~     intervention is combined to group cognitive therapy (an already proven efficacious format)~     and compared to cognitive individual therapy.~   "
154580|NCT01542944|"~     The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar~     version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem~     cells from normal sibling donors for allogeneic stem cell transplantation.~   "
154581|NCT01542931|"~     Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally~     advanced or aggressive cancers, and to improve the chance of eradication of the locoregional~     lesions by radical surgery and/or radiotherapy. However, there are still debates on the~     clinical value of induction chemotherapy for patients with advanced and resectable oral~     squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of~     TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with~     locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival~     rate, local control, and safety.~   "
154552|NCT01543321|"~     Late dyskinetic syndrome with neuroleptics, or tardive dyskinesia, is the appearance of~     abnormal involuntary movements (AIM) in patients treated with antipsychotics for at least~     three months. This important public health issue arises for 15-20% of patients treated with~     neuroleptics, the most prescribed psychotropic drugs in mental disorders in France, and~     seriously impacts the patients' quality of life. In over 50% of cases, it is~     irreversible-that is to say that he will persist despite discontinuation of the offending~     drug.~      Risk factors have been described: the age and female gender are established, a higher dosage~     of antipsychotic, a long-term treatment, a psychiatric condition other than schizophrenia are~     likely risk factors, intermittent treatment, previous acute dyskinesia, neuroleptics or~     powerful, longer term use of corrective treatments including anticholinergics are still~     discussed.~      Apart from preventive treatment, which consists in using antipsychotics as being coerced,~     support is disappointing: the etiological treatment, which is to stop the offending~     antipsychotic, is effective only in less than 50% of cases, the syndrome is most often late~     irreversible. Must still have the possibility to interrupt the treatment, which is usually~     impossible in the risk of decompensation of the mental illness for which the neuroleptic was~     prescribed. Remains symptomatic treatment: functional neurosurgery is only for extreme cases,~     because it is not without risk, in terms of morbidity and mortality. So it's the medication~     that is most often offered: many drugs have been proposed, a direct result of the~     multiplicity of neurotransmitter systems implicated.~      However, in the vast majority of cases, this approach is disappointing not to say~     ineffective. The only exception is the tetrabenazine, marketed under the name of Xenazine®.~     Empirically, neurologists specializing in pathology of the movement are almost unanimous: its~     efficiency is very good, with good tolerance. Some preliminary studies have reinforced this~     impression. However, their level of evidence remains low and that is why the investigators~     propose to implement a prospective multicenter clinical trial, double-blind with placebo~     which will include two groups of 27 patients.~   "
154553|NCT01543308|"~     The protein composition of HDL is complicated. The investigators have identified 40 distinct~     proteins associated with HDL by proteomics technology, and these proteins have been confirmed~     to be related to the function of anti-inflammation, anti-oxidation, improvement of~     endothelial function, inhibition of thrombosis and so on. And the investigators also found~     that the levels of some proteins in HDL changed in patients with coronary heart disease,~     compared with the healthy control group.~      So, this study is to conduct in the two following aspects: enlarge the sample size to verify~     the preliminary results to find new research ideas of pathogenesis and biomarkers for~     coronary heart disease; and study the changes of HDL protein composition in patients with~     coronary heart disease before and after statins treatment using proteomics technology in~     order to find the mechanism of statins pleiotropic effects and indicators for evaluating the~     treatment effectiveness.~   "
154554|NCT01543295|"~     This study has been designed to evaluate the performance of the Chembio Diagnostics Systems,~     Inc. DPP® Syphilis Screen and Confirm rapid test. The device is intended to qualitatively and~     simultaneously detect the presence of antibodies to Non-treponemal and Treponema pallidum~     antigens in whole blood (capillary and venous), serum or plasma.~   "
154555|NCT01543282|"~     This is a randomized controlled study comparing EUS-FNA with 22 gauge and 25 gauge needles in~     consecutive patients.~      Summary~      Background: three needle sizes for endoscopic ultrasonography guided fine needle aspiration~     (EUS-FNA) are currently available: 22 Gauge (G), 25 G and 19 G. However, well design studies~     comparing them regarding efficacy and feasibility are lacking.~      Aims: to investigate diagnostic yield, specimen adequacy, feasibility and complications of~     the conventional 22 G compared with the 25 G needle.~      Methods: patients ≥ 18 years, referred to EUS-FNA for a solid lesion will be considered for~     inclusion. Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis, significant~     coagulopathy (APT < 50% or platelets < 50000/mm3), use of warfarin or other anticoagulants,~     use of clopidogrel within 7 days of EUS, inability or refusal to sign the informed consent~     and pregnancy or suspected pregnancy will be excluded.~      Participants will be randomized to 22 G needle and 25 G FNA. Chi-square test will be used to~     compare proportions. Continuous variables will be compared using Student´s t test. A~     two-tailed P values of less than 0.05 will be considered statistically significant. The~     diagnostic yield of 25 G and 22 G needle will be evaluated by four criteria: sensitivity,~     specificity, positive predictive value and negative predictive value. An expected rate of 85%~     diagnostic yield from EUS guided FNA by using 22G needle will be considered. By using a power~     of 80% and an α value of 0.05 would be necessary 120 patients per group to detect a 15%~     difference in the rate of diagnostic yield.~   "
154556|NCT01543269|"~     This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1,~     following oral administrations in healthy volunteers.~      The study shall be divided into four plans as given below:~        1. Plan I: Single dose escalation trial~        2. Plan II: Multiple dose escalation trial~        3. Plan III: Food effect trial.~        4. Plan IV: Gender Effect trial.~      The safety and tolerability shall be evaluated using physical examinations, Standard~     laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG)~     and thyroid scanning. Spontaneously reported and solicited adverse events will also be used~     for safety parameters.~   "
154557|NCT01543256|"~     The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS)~     to plastic stents for the treatment of benign biliary strictures secondary to chronic~     pancreatitis as it pertains to stricture resolution rates, complication rates and number of~     ERCP procedures during 24 months.~      Statistical testing will be performed to determine if the rate of stricture resolution for~     the metal stent is non-inferior to the plastic stent group.~   "
154558|NCT01543243|"~     This study aims to examine~        1. the feasibility~        2. immediately~        3. long term effects on postural control and strength of mechanical SR-WBV intervention in~          a frail elderly population.~   "
154559|NCT01543230|"~     The primary objective of this investigation is to evaluate survivorship at ten years. For~     this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a~     constant 1% per year.~   "
154560|NCT01543217|"~     The aim of this study is to reduce the number of subsequent hospital admissions and/or~     emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary~     disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM)~     program compared to standard discharge instructions and planning.~   "
154561|NCT01543204|"~     This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who~     have lost a satisfactory response to adalimumab.~   "
154562|NCT01543191|"~     The purpose of this study is to determine whether PUR118 is safe and tolerable in a~     population of subjects with Cystic Fibrosis.~   "
154563|NCT01543178|"~     This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550~     mg three times a day in patients with IBS with diarrhea who respond to initial treatment of~     rifaximin 550 mg three times a day.~   "
154568|NCT01543113|"~     Background: Metastatic melanoma has a devastating prognosis and is one of the top causes of~     cancer death in young patients. Until now, available therapies were few and unreliable, but~     recent understanding of melanomas' molecular pathways has improve their classification and~     new clinical strategies have been proposed.~      Initial studies showed that B-Raf/N-Ras mutations (respectively V600E and Q61) are the most~     frequent alteration being present in 70 to 80% of melanomas, characterizing non Chronic~     Sun-induced Damage skins (CSD). These include Superficial Spreading Melanomas (SSM) and~     Nodular Melanomas (NM). Other studies showed that c-Kit mutations are presently the~     predominant activating mutation (20 - 40 %) in Acro-Lentiginous Melanomas (ALM), Mucous~     Melanomas (MM) and in melanomas arising on CSD skin. c-Kit mutation pattern is more complex~     with four exons being affected leading to different mutations, which incidence and biological~     impact are less documented.~      BRAF/NRAS genetics alterations drive constantly cell growth, being thus attractive targets.~     Spectacular results have indeed been obtained with the BRAF inhibitor that targets the V600E~     BRAF-mutated form. Data from GIST disease revealed that the different c-Kit mutations~     modulate differently c-Kit function and the response to targeted therapies.~      Because c-Kit targeted therapy is a critical clinical issue, the investigators aimed to~     identify the most frequent mutations present in our population to propose appropriate~     screening test and adapt the therapy.~      Methods: 250 melanoma samples corresponding to an homogeneous white-Caucasian population~     (Brittany, France) will be screened. c-Kit exons 11, 13, 17 and 18 will be sequenced (direct~     sequencing and pyrosequencing when possible). c-Kit copy number will be quantified by q-PCR~     and level of c-Kit determined by immunohistochemistry (IHC, CD117). Samples will also be~     analyzed for B-Raf mutations in codon 464, 466, 469 and 600, and for N-Ras mutations in codon~     12, 13 and 61 (Pyrosequencing).~      Expected Results:~      Taken together, the investigators anticipate that the present genetic analysis of the tumours~     from patients with advanced melanoma will first document the type and frequency of cKit~     mutations, will confirm or not that BRAF, NRAS and cKit mutations are mutually exclusive and~     document their repartition in the melanomas sub-types. Finally this study will clue~     researchers in to how well patients will respond to a therapy that targets the~     growth-promoting proteins BRAF/NRAS and cKIT.~   "
154569|NCT01543100|"~     Blood circulating endothelial cells (CEC) and microparticles (MPs) are described in the~     literature to be associated with vascular failures and dysfunction that reflect~     neo-angiogenesis and risk of thrombosis, respectively. There a few number of CEC in healthy~     patients although they significantly increase in several cancers including myeloma. However,~     no study explored to date a correlation of CEC and/or circulating endothelial progenitors~     (CEP) and MPs with the tumoral growth of monoclonal gammopathy. On the other hand, there is~     no study measuring the CEC and CEP directly in the bone marrow. The investigators aim is to~     evaluate these 2 original features in patients with monoclonal gammopathy: monoclonal~     gammopathy of undetermined signification (MGUS) and myeloma. This is a preliminary~     multicentric study.~   "
154570|NCT01543087|"~     This study is to assess the longevity of immune response in adolescents for approximately 48~     months after receipt of a primary series of bivalent rLP2086 vaccination, which is then~     followed by a booster dose and an assessment of immune response for 12 or 26 months post~     booster vaccination.~   "
154571|NCT01543074|"~     This pilot, three-week study will help scientists understand more about how the foods people~     eat can modify histone deacetylases, enzymes the body produces naturally. Broccoli sprout~     extract (BSE) and garlic oil are thought to modify these enzymes. The purpose of this study~     is to see if taking broccoli sprout extract alone, garlic oil alone, or broccoli sprout~     extract and garlic oil together, can decrease the action of histone deacetylase (HDAC) and~     turn on genes in white blood cells. There will be 80 people in this study.~   "
154572|NCT01543061|"~     The objectives of the investigation will be to assess the effect of the repeated usage of a~     new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with~     contact lens related comfort problems and to quantify any potential benefit.~   "
154573|NCT01543048|"~     CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They are~     subsequent to a persistent HPV infection and are classically treated by conization.~     Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2~     years of follow-up. Follow-up is crucial to detect and treat recurrence and to select high~     risk women who might develop cervical cancer. Colposcopy and cytology have been recommended~     since 1989 by French ANAES, but these methods have poor sensitivity and specificity. However,~     DNA HPV testing is more sensitive and has demonstrated a very high negative predictive value,~     while specificity and positive predictive value remain average. Other HPV markers like~     genotyping, viral load and integration begin to be used in screening but have not been~     investigated in CIN2/3 follow-up to assess the values of various HPV markers which predict~     CIN2/3 recurrence after conization. The primary objective is to describe HPV expression~     (genotyping, viral load, mRNA E6 and E7) at the time of conization and during the follow-up~     period (6, 12, 24 months) and to assess the prognostic value of HPV 16 expression (viral~     load, mRNA E6 and E7) to determine the risk of CIN2/3 recurrence after conization, compared~     to the other clinical and virological risk factors.~   "
154574|NCT01543035|"~     Dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein (LDL)~     cholesterol and reduced high-density lipoprotein (HDL) cholesterol levels, is common in~     HIV-infected individuals, and has been associated with HIV infection itself and~     antiretroviral therapy (ART). These abnormalities are well-established markers of~     cardiovascular (CVD) risk in the general population. Studies have suggested an increased risk~     of CVD associated with ART exposure over and above that conveyed by traditional~     cardiovascular risk factors. In HIV population to reduce lipid parameters, the most usual~     clinical strategy remains to add a statin treatment.~      Recent studies suggested ART switch can represent an interesting alternative to statins to~     reduce lipid plasma levels.~      The purpose of this study is to evaluate the frequency with which the replacement of LPV/r~     (lopinavir/ritonavir), ATZ/r (atazanavir/ritonavir), DRV/r (darunavir/ritonavir) or EFV~     (efavirenz) by ETR (Etravirin) in dyslipidemic patients with suppressed viremia would obviate~     the necessity to administer statins.~      A prospective, phase III study in which the statin treatment of dyslipidemic HIV patients on~     antiretroviral drugs (ARVs) will be interrupted during 4 weeks is proposed.~      At week 4, patients qualifying for a lipid lowering drug (calculated LDL-C≥ 3mmol/L) will~     replace EFV, LPV/r, DRV/r or ATZ/r by ETR. The proportion of patients not qualifying anymore~     for a statin treatment at 12 weeks (i.e. after 8 weeks of ETR treatment) will be determined.~     Additionally, the lipid level changes will be assessed at 12 weeks. Inflammatory markers will~     be measured at baseline, at drug switch and at the end of the study~      Study drug will be provided by the drug manufacturer (Janssen-Cilag, AG). Compliance for~     study drug will be done at week-4 and week-12, Returned study medication will be counted and~     the amount notified on the Case Report Form (CRF).~   "
154575|NCT01543022|"~     The Counter Pulsation Device (CPD) System 'Symphony' is intended to provide counter pulsation~     therapy for up to thirty (30) days to patients with chronic heart failure who have persistent~     worsening of their condition despite optimal medical therapy. Patients will be in New York~     Heart Association (NYHA) Class IIIb or IV heart failure and have exhausted all medical or~     surgical options.~   "
154576|NCT01543009|"~     The aim of this study is to determine if local application of heat increases the probability~     of insertion of peripheral venous catheter at the first attempt, reduces the time needed to~     obtain cannulation and maintains the analgesic effect of Emla in children undergoing~     peripheral venous cannulation and previously treated with local analgesia with Emla.~   "
154582|NCT01542918|"~     This is a Phase I study, which means that the goal is to see if the study treatment is safe.~     The purpose of this study is to test the safety of Lenalidomide at different dose levels, and~     to test the safety of Lenalidomide alone or in combination with Rituximab (also known as~     Rituxan®).~   "
154583|NCT01542905|"~     The purpose of this study is to examine clinical and neuropsychiatric effects of Korean Red~     Ginseng and examine changes in brain structure, function and metabolites. A total of 60~     healthy volunteers will be recruited and will be assigned to either Korean Red Ginseng group~     or placebo group. Individuals will be examined through clinical assessment,~     neuropsychological function tests and neuroimaging.~   "
154584|NCT01542892|"~     Several trials have found that nutritional supplementation can elicit an increased rate of~     skeletal muscle protein synthesis following a single bout of exercise in both young and older~     individuals. However, there have been no studies that have investigated if nutritional~     supplementation and exercise can cause a sustained increase in physical functioning and fat~     free mass, particularly in older adults with functional limitations. This study will compare~     the effects of a nutritional supplement versus a placebo on exercise training induced changes~     in physical functioning older adults who are at risk for mobility disability.~   "
154585|NCT01542879|"~     A research study on the diagnosis of spread of disease for children who have been diagnosed~     with solid tumors using a new whole body imaging technique and a new MR contrast agent~     (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a~     child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron~     Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG)~     scanning. The purpose of this study is to determine if newer imaging tests referred to as~     whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of~     the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The~     advantage of the new imaging test is that it is associated with no or significantly reduced~     radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole~     body MR and PET/MR will be compared with that of the conventional, standard imaging studies~     for tumor detecting.~   "
154586|NCT01542866|"~     This is a prospective pilot study to evaluate the usability and applicability of a self~     monitoring test of visual function with the handheld Health Management Tool (HMT) to remotely~     monitor neovascular Age Related Macular Degeneration (AMD) to detect a potential change in~     disease status.~   "
154587|NCT01542853|"~     MRI has shoved little correlation with the clinical finding during treatment of~     spondylodiscitis (infection in the vertebrae and/or discs). Since PET/CT is almost as good as~     MRI in diagnosing spondylodiscitis the hypothesis and this study is that PET/CT is better in~     predicting residual disease in patients with spondylodiscitis.~      Preliminary study.~   "
154588|NCT01542840|"~     The purpose of this study is to compare injecting local anesthetic (numbing medication) in~     different patterns around a major nerve in the leg. Patients who undergo surgery to the lower~     leg and/or foot are usually offered the option of a nerve block to help with pain control~     after surgery. A nerve block involves injecting local anesthetic (numbing medicine) by a~     nerve or nerves that provide sensation to the area where surgery will be performed. The local~     anesthetic (numbing medication) numbs up the area where the surgery is performed and helps~     decrease the amount of pain felt after surgery. The local anesthetic (numbing medication) can~     be injected in various patterns by a nerve, such as in one spot by a nerve or completely~     surrounding a nerve. The local anesthetic will be either injected around the sciatic nerve or~     will injected in a way that will split the sciatic nerve into the two component nerves that~     make it up, the tibial and sciatic, and surrounds each nerve.~      The hypothesis is that subjects in the group that local anesthetic is injected in a pattern~     that separates the sciatic nerve into the two component nerves may have a faster onset time~     of regional anesthesia and block success than subjects in the group that have the local~     anesthetic injected at around the nerve.~   "
154589|NCT01542827|"~     Topical menthol gels are classified 'topical analgesics' and are used to relieve aching and~     tenderness of muscles and joints. However, double-blind randomized controlled trials are~     lacking. Here the investigators examine - in a double-blind randomized controlled cross-over~     trial - the acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol~     scent) on neck pain.~   "
154590|NCT01542814|"~     This image-acquisition study is designed to acquire the study image data and establish and~     document the clinical findings for each subject. The acquired data will be used to support~     FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital~     Mammography) and future regulatory submissions.~   "
154591|NCT01542801|"~     -  For the prevention of spontaneous bacterial peritonitis (SBP) in patients with liver~          cirrhosis, norfloxacin 400mg per day is a standard regimen.~        -  Ciprofloxacin 750 mg per week is also known to be effective for prevention of SBP. In~          addition, ciprofloxacin once weekly administration is more convenient and less costly.~        -  Therefore ciprofloxacin once weekly could be more useful if the the efficacy is~          comparable to norfloxacin once daily.~        -  This study aims to prove ciprofloxacin once weekly administration is as effective as~          norfloxacin once daily administration for the prevention of SBP in cirrhotic patients~          with ascites.~   "
154592|NCT01542788|"~     This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection~     who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants~     were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to~     match SOF+placebo to match RBV. Randomization was stratified by presence/absence of~     cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.~   "
154593|NCT01542775|"~     The purpose of this study is to examine the effects of exercise on diverse cardiometabolic~     risk factors and indicators of atherosclerosis in patients with type 2 diabetes mellitus~     (T2DM).~   "
154607|NCT01542593|"~     Proper selection of ureteral stent length might help in reducing comorbidities associated~     with ureteral stenting, currently there is no standardized way of measuring ureteral length.~      Measurement of ureteral length according to Computed Tomography (CT) scan might provide~     useful information when selecting the length of a ureteral stent. Our aim in this study is to~     compare ureteral measurements using CT scan and measurement of actual ureteral length~     measured during ureteral stenting.~   "
154594|NCT01542762|"~     Currently, guidelines and clinical practice differ considerably with respect to use of~     anticoagulant treatment during cast immobilization of the lower leg. Trials that have been~     carried out were aimed at efficacy only, had small sample sizes and therefore mainly used~     asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could~     not be established, hence the current controversy. In the proposed study the investigators~     will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the~     investigators will follow subjects with an adverse event for a longer period, during which~     the investigators will assess the long term sequelae of these events. Lastly, the~     investigators will determine high risk groups that will benefit most from anticoagulant~     treatment.~      Objective: Comparative effectiveness research to determine cost-effectiveness of two existing~     policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster~     cast immobilization following surgical or conservative treatment. In addition the~     investigators will investigate personalized prophylaxis based on genetic and acquired risk~     factors.~   "
154595|NCT01542749|"~     The DAXOR Corporation manufactures and distributes a blood volume analyzer. The analysis is~     based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. In~     addition to calculating human blood volume it is hypothesized that measurement of the~     dilution of the tracer can also yield an accurate measurement of total body albumin.~   "
154596|NCT01542736|"~     The purpose of this study is to study the efficacy of the combination of reduced dose~     craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with~     concurrent carboplatin and vincristine administration for metastatic classical histology~     medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.~   "
154597|NCT01542723|"~     Currently, guidelines and clinical practice differ considerably with respect to use of~     anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were~     aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic~     thrombosis as endpoint. From these trials an overall risk benefit-balance could not be~     established, hence the current controversy. In the proposed study the investigators will use~     relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators~     will follow subjects with an adverse event for a longer period, during which the~     investigators will assess the long term sequelae of these events. Lastly, the investigators~     will determine high risk groups that will benefit most from anticoagulant treatment.~      Objective: Comparative effectiveness research to determine cost-effectiveness of two existing~     policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the~     knee. In addition the investigators will investigate personalized prophylaxis based on~     genetic and acquired risk factors.~   "
154598|NCT01542710|"~     The purpose of this study is to compare 2 fixed combination medications in intraocular~     pressure lowering.~   "
154599|NCT01542697|"~     intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and~     analgesic consumption in postoperative period following laparoscopic cholecystectomy.~   "
154600|NCT01542684|"~     The goal of this clinical research study is to learn if the combination of azacitidine and~     GM-CSF can help to control MDS. The safety of these drugs will also be studied.~      Azacitidine is designed to block certain proteins that stop the function of tumor-fighting~     genes. By blocking the bad proteins, the tumor-fighting genes may be able to work better.~      Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white~     blood cells. This may help to fight infections.~   "
154601|NCT01542671|"~     The primary objective of the study is to evaluate the effectiveness of tailored lifestyle~     intervention in primary care by comparing changes in the primary measure of weight and body~     mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and~     fruit/vegetable servings within the two arms (intervention and control) of the study. It is~     hypothesized that the intervention cohort will demonstrate greater reductions in body weight,~     body neglect, and fat calories consumed and greater increases in physical activity and~     fruits/vegetable servings after two years compared to the control cohort. The study also aims~     to evaluate and compare the cost of intervention for purpose per each unit of measure lost~     between the two arms of the study as a secondary objective. The cost of intervention will be~     evaluated as it relates to study replication.~   "
154602|NCT01542658|"~     This study is to reveal any potential advantage of Robot-assisted Laparoscopic Myomectomy~     (RLAM) over Traditional Laparoscopic Myomectomy (TLM) by comparing the perioperative~     variables and short-term outcome of RALM and TLM patients.~   "
154603|NCT01542645|"~     The primary aim of this randomized, double-blind study is to examine the effect of a single~     intraoperative dose of methadone on postoperative pain and analgesic requirements in patients~     undergoing cardiac surgery with cardiopulmonary bypass. These patients will be compared to~     subjects receiving a standard dose of the traditional intraoperative opioid (fentanyl).~     Secondary outcome measures to be assessed will include standard recovery variables (such as~     length of postoperative intubation, ICU length of stay, incidence of nausea or vomiting,~     level of sedation). In addition, patients will be assessed for the development of chronic~     postoperative pain.~   "
154604|NCT01542632|"~     A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose~     schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare~     the immunogenicity of different dose schedules of the vaccine.~      Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of~     viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then~     on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue~     neutralizing antibodies in serum were obtained at baseline [during the screening period or on~     day of vaccination (Day 0)], then on Days 30, 90 and 120.~      The entire duration for each individual subjects participation was approximately 5 months~     including recruitment and collection of data for primary outcomes (through Day 120).~   "
154605|NCT01542619|"~     This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation~     cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in~     comparison to placebo.~   "
154606|NCT01542606|"~     This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes~     into contact with vaginal secretions having an elevated pH level~   "
154650|NCT01542034|"~     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of~     submental fat (fat below the chin).~   "
154608|NCT01542580|"~     The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system~     utilizing offset on either the tibial component, femoral component, or both in terms of the~     restoration of mechanical alignment, clinical outcomes and survivorship.~   "
154609|NCT01542567|"~     This study is designed to test the effectiveness of diclofenac suppositories in the~     prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.~   "
154610|NCT01542554|"~     The purpose of this study is to investigate the effect of low glycaemic diet on blood glucose~     control in Chinese type 2 diabetic patients.~   "
154611|NCT01542541|"~     Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG)~     that is taken-up by active cells such as cancer cells. This contrast can then be seen in the~     body using the PET-CT scanner. However, cells in the colon also take up the FDG, and can~     produce false positive signals from the colon. Our hypothesis is that much of this signal~     comes from bacteria that are present in high concentrations in the colon. If this is the~     case, using an antibiotic to suppress the activity of bacteria may improve the ability of~     PET-CT to distinguish abnormal cells from normal cells in the colon.~   "
154612|NCT01542528|"~     The investigators are conducting this randomized trial to determine if IBBS (Integrated~     Brain, Body, and Social)intervention is an effective treatment for ADHD (attention Deficit~     Hyperactivity Disorder) in two culturally distinct settings; Hamden and New Haven,~     Connecticut and Beijing, China. A subgroup of the children in the US will also participate in~     an EEG study before and after IBBS and will be compared to a group of typically developing~     children.~      IBBS combines computer-presented brain exercises with a physical education curriculum, all of~     which is designed to be fun, as well as to enhance sustained attention, inhibitory control~     and other executive capacities.~      IBBS is a school-based program in which groups children (composed of children with ADHD,~     children at risk for ADHD, and typically developing children) alternate between a classroom~     setting and the gymnasium four days a week for 15 weeks. These mixed age groups will be~     composed of children with ADHD, children at-risk for ADHD, and typically developing children.~     Although IBBS takes place in a group setting, the computer game component individualizes~     instruction to maximize benefit for each child.~      During the last year of the grant, we will be introducing a pilot study of an organizational~     skills training (OST) that will provide individualized parent and child training for improved~     executive functioning in children randomized to the OST plus home-based program.~   "
154613|NCT01542515|"~     Hypothesis:~      The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for~     the surgical treatment of basal joint arthritis of the thumb.~      A variety of surgical procedures have been developed for the treatment of basal joint~     osteoarthritis of the thumb. Problems with persistent pain and poor function have been~     reported to some degree for each of these procedures. Using the concept of an implant acting~     as a spacer and stabilizer the investigators proposed and implemented a novel surgical~     technique using allograft knee meniscus as a biologic implant for the treatment of basal~     joint arthritis of the thumb.~   "
154614|NCT01542502|"~     This will be a randomized, double-blind, crossover pilot study to measure the safety and~     feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart~     failure with preserved ejection fraction.~   "
154615|NCT01542489|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the effect of~     Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events~     in insulin treated subjects with type 1 or type 2 diabetes.~   "
154616|NCT01542476|"~     This study is conducted in Europe. The aim of this study is to assess the well-being of~     patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type~     2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting~     basal insulin analogue is needed.~   "
154617|NCT01542463|"~     This study conducted in Europe. The aim of this study is to evaluated the use of insulin~     detemir (Levemir®) in insufficiently controlled patients with type 1 or type 2 diabetes.~   "
154618|NCT01542450|"~     This trial is conducted in Japan. The aim for this trial is to investigate the~     pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects~     with type 1 diabetes mellitus.~   "
154619|NCT01542437|"~     Patients with stage IIIB and IV lung adenocarcinoma and progression to first-line~     chemotherapy were enrolled to receive afatinib 40 mg/day. Mutational EGFR and HER-2 status~     were assessed by RT-PCR. HER2 amplification was evaluated by FISH. Plasma HGF levels were~     measured by ELISA before and 2 months (mo) after the start of treatment. We assessed changes~     in serum HGF levels and their association with objective response rate (ORR), PFS and overall~     survival (OS).~   "
154620|NCT01542424|"~     This trial is conducted in Europe. The aim of this trial is to investigate efficacy and~     safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects~     with type 1 or 2 diabetes mellitus.~   "
154621|NCT01542411|"~     This study evaluated the effect of anticoagulant treatment on the live-birth rate in women~     with a history of at least two continuous unexplained miscarriages or thrombophilia. It also~     compared two methods of treatment with aspirin and aspirin plus heparin.~   "
154622|NCT01542398|"~     The main research question of the study is whether a family-based, life-skills focused~     psychosocial intervention is effective in reducing psychological distress and stigma and~     improving inter-personal relations and functioning among war-affected children in the~     Democratic Republic of Congo.~   "
154623|NCT01542385|"~     The purpose of this research project is to improve how we treat heart attacks. The study will~     assess whether it might not be better to wait a few hours before implanting the coronary~     stent into the coronary artery rather than implanting it immediately, in order to allow the~     drugs to completely dissolve the clot. This might help to reduce the risks of the clot~     migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able~     to reduce the size of the infarction and reduce the risk of suffering from heart failure~     following a heart attack.~   "
154756|NCT01540643|"~     The purpose of this registry is to obtain case reports of physician experience with the~     Spiral-Z® graft under routine clinical care.~   "
155102|NCT01536119|"~     The purpose of this trial is to evaluate the effectiveness of a Coparenting Breastfeeding~     Support Intervention with first time parents on exclusive breastfeeding rates at 12 weeks~     postpartum. Partner support and the coparenting relationship will also be evaluated.~   "
154624|NCT01542372|"~     This project aims to investigate the efficacy of two models to treat Posttraumatic Stress~     Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is~     giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine~     reuptake inhibitor (SSRI/SSRN), with paroxetine being the first-line agent. For those~     patients who still have PTSD, the second step is either another medication or a culturally~     sensitive cognitive behavioral therapy (CBT). The investigators hypothesize that patients~     will improve in both models, but more so in the the CBT model.~   "
154625|NCT01542359|"~     The proposed study will compare a well defined and integrated yoga practice (postures/breath~     control/meditation) to a conventional exercise program in reducing hypertension. The expected~     outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial~     stress, and the autonomic system in individuals with pre- and Stage I hypertension. The~     information gained in this study will have a positive impact by providing critical~     preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial~     on the effects of yoga on individuals with hypertension.~   "
154626|NCT01542346|"~     This is a double blinded randomized study investigating if subcutaneous adaption has an~     impact on cosmetic outcome after Caesarean delivery.~   "
154627|NCT01542333|"~     RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory~     may help doctor learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms~     tumor.~   "
154628|NCT01542320|"~     The purpose of this study is to understand how a probiotic might change the immune response~     of healthy infants.~   "
154629|NCT01542307|"~     This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in~     acute migraine headache.~   "
154630|NCT01542294|"~     The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin~     combination chemotherapy based on the adverse events and survival period by performing a~     phase I/II study of this combination in patients with D2 resection of gastric cancer.~   "
154631|NCT01542281|"~     1. To determine whether a combined nutritional support program and exercise-based~          prehabilitation is superior to nutritional support alone in increasing functional~          recovery and reducing post-operative morbidity after surgery for HPB malignancy.~        2. To understand which measures of immediate surgical recovery are sensitive to~          prehabilitation interventions and predict change in later outcome measures.~   "
154632|NCT01542268|"~     The purpose of this study is to determine the therapeutics effectiveness of oral~     pentoxifylline treatment in patients with IBS.~   "
154633|NCT01542255|"~     SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low~     Dose Vinblastine, Cyclophosphamide, and Dacarbazine.~      Patients with measurable metastatic melanoma are eligible. All patients will be treated as~     outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be~     treated continuously, until evidence of progression of disease, or for up to two cycles~     following disappearance of all disease. A cycle will be defined as three weeks of continuous~     therapy with a one week rest.~   "
154634|NCT01542242|"~     Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in~     patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive~     effect and has been associated with weight loss in patients with type 2 diabetes. Liraglutide~     use in the treatment of PWS is limited to one case report by Cyganek et el (See attached~     Citation). In this case report, the subject showed improvements in hemoglobin A1c and body~     weight over 14 weeks.~      The investigators plan to examine the use of liraglutide in a single subject with Prader~     Willi Syndrome and type 2 diabetes for one year. The investigators will examine clinical~     parameters, clinical assessment of hunger, and biochemical markers of diabetes and lipid~     control.~   "
154635|NCT01542229|"~     As in the general population, there is no clear standard of care within Veterans Affairs~     Medical Centers for treating posttraumatic stress disorder (PTSD) among individuals with~     severe mental illness (SMI). This is a considerable issue because trauma, posttraumatic~     stress disorder (PTSD), and severe psychiatric comorbidity are particularly common among~     Veterans and this symptom presentation clearly exacerbates the overall course and severity of~     mental illness. This study is significant in that it proposes to establish the efficacy of a~     frontline exposure based intervention for posttraumatic stress disorder (PTSD), Prolonged~     Exposure, for improving critical clinical, quality of life, and cost outcomes among Veterans~     with severe mental illness (SMI) enrolled in VA healthcare. Collectively, it is anticipated~     that these data will establish a much needed clinical course of action for what is considered~     a vulnerable yet highly underserved patient population.~   "
154636|NCT01542216|"~     With the increased success in breast cancer therapies, survivors develop unhealthy changes in~     body composition, such as muscle loss and fat gains, which lead to increased risk of~     cardiovascular disease and diabetes in survivorship. This study will examine the effects of a~     nutrition, cardiovascular and strength exercise program compared with a yoga program~     (representing usual care) on body composition and metabolism in recently diagnosed breast~     cancer patients. Nutrition and exercise may improve various body composition and metabolic~     parameters, which may improve quality of life in survivorship, reduce risk of recurrence and~     reduce the risk of developing cardiovascular disease and diabetes in survivorship.~   "
154637|NCT01542203|"~     This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This~     study is designed to measure drug concentrations in the blood of 18 female breast cancer~     patients who require doxorubicin (30 minute infusion) and cyclophosphamide (30 minute~     infusion) as part of standard medical care. Up to a total of 40 adult female participants~     will be consented for the study at the cancer center. Eighteen of these participants are~     needed to complete the study. The others will likely be screen failures. The participants~     will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just prior~     to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h after~     the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The intravenous~     catheter will be removed when the participant is discharged from the cancer center on day 1.~     The participant will be asked to return to the cancer center at 12-24 and 24-72 hours to have~     the final 2 blood draws conducted. The participants must be treated with Doxorubicin and~     Cyclophosphamide in order to participate in this pharmacokinetic analysis study.~   "
154638|NCT01542190|"~     The purpose of this study is to compare effects of preoperative and postoperative use of~     topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.~      Patients scheduled to undergo phacoemulsification will be randomized to receive either~     topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo~     group) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group)~     for three days preoperatively and four weeks postoperatively. The primary outcome 5 weeks~     after surgery will be angiographic cystoid macular edema.~   "
154639|NCT01542177|"~     This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer~     using an imaging test called positron emission tomography (PET). Hypoxia can influence how~     pancreatic cancer grows and responds to treatments such as chemotherapy and radiotherapy. The~     use of PET scans to measure hypoxia may be better and simpler than the approaches used~     previously. This study will assess whether or not PET scans using a tracer called 18F-FAZA~     (18F-Fluoroazomycin Arabinoside) can provide useful information about hypoxia in pancreatic~     cancer. Also as part of the study, a blood sample will be taken to study biomarkers~     (substances in the body that may be important indicators of hypoxia and/or pancreatic cancer)~     that may be useful in studying pancreatic cancer and hypoxia.~   "
154640|NCT01542164|"~     The overall purpose of this study is to examine the effect of calcium on fecal fat and energy~     excretion.~   "
154641|NCT01542151|"~     This randomized clinical trial will examine if there are any differences between post-dates~     inductions (inductions after 40 weeks of pregnancy) begun in the morning compared to the~     evening for first-time mothers. Sleep and fatigue measures will be measured to see if they~     differ by time of induction. Other measures will include the rate of births within 24 hours~     of admission, length of labor, use of labor analgesics, and method of delivery.~   "
154642|NCT01542138|"~     Axillary hyperpigmentation is a frequent consultation in dark skin populations although its~     exact prevalency is unknown. Currently, there are not studies about physiopathology and~     treatment for this entity. The objective is to evaluate the depigmenting effect of topical 4%~     niacinamide versus 0.05% desonide in axillary hyperpigmentation.~      At least 30 axillas with hyperpigmentation in individuals of phototype III-V, aged 18-50~     years are going to be randomly assigned to receive niacinamide, desonide or placebo daily. No~     hygienic habits will not be modified. Volunteers will be evaluated at baseline and for 9~     weeks, by means of histological, histochemical and immunohistochemistry analysis, as well as~     Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography control.~   "
154643|NCT01542125|"~     The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation,~     occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH),~     this frequently performed procedure is currently done without anesthetic, making it a painful~     and uncomfortable experience for the child and their caregiver(s). Liposomal Lidocaine is a~     relatively new effective and needle-free topical anesthetic. The investigators were~     interested in examining its effectiveness in pain reduction in children undergoing Perc Pin~     removal. Objective: To determine if Liposomal Lidocaine is effective in reducing pain in a~     pediatric population undergoing Perc Pin removal compared to a placebo. Hypothesis: The~     investigators hypothesize that Liposomal Lidocaine would significantly reduce pain during~     Perc Pin removal compared to a placebo. Research Design: This was a triple-blinded,~     randomized placebo-controlled clinical trial with 281 patients (140 patients each in the~     Maxilene and 141 in the Placebo groups). Pain measurements, using the Oucher Scale (children)~     and a 10-cm Visual Analog Scale (parents and caregivers) were collected prior to~     randomization and immediately after Perc Pin removal. Data was analyzed using a Student's~     t-test and the Wilcoxon signed ranks test.~   "
154644|NCT01542112|"~     This new model to manage patient expectations was developed based on our international study~     conducted in four countries. The model is designed to address the main issues that lie at the~     core of initiatives to manage patient expectations and improve patient satisfaction. It is a~     structured interventional set of activities, which gives the clinician an opportunity to meet~     patient expectations and needs and thereby, improve patient satisfaction.~      The interventional model comprise teachable-learnable communicative steps occurring between~     the clinician and the patient which are: Gather information on the patient's expectations and~     perception of the hospitalization, Respond, Provide relevant information and Document the~     intervention.~      The intervention includes all frontline care givers; however, most of the activities will be~     done by the nursing staff. The set of activities will be executed by the nurses at three~     separate periods of time during the patient's hospitalization: time of admission,~     intermediate time and at time of discharge.~      The study is based on the hypothesis that a structured interventional model will~     significantly improve patient satisfaction during hospitalization.~   "
154645|NCT01542099|"~     The purpose of this study is to evaluate the effect site concentration of remifentanil~     blunting hemodynamic changes to tracheal intubation of single or double lumen tubes.~   "
154646|NCT01542086|"~     The investigators aim to compare the cost-effectiveness of CCTA and myocardial SPECT in~     patients with intermediate pre-test probability of CHD. To this end, patients with~     intermediate pre-test probability of CHD will be randomized 1:1 to either CCTA and myocardial~     SPECT. The patients will be analyzed for cost and also, for outcome.~   "
154647|NCT01542073|"~     This is an open-label PET/CT (positron emission tomography/computed tomography) study to~     investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in evaluation of myocardial~     infarction. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be~     intravenously injected into myocardial infarction patients. Visual and semiquantitative~     method will be used to assess the 68Ga-BNOTA-PRGD2 PET/CT cardiac images and compared to the~     99mTc-MIBI SPECT myocardial perfusion images and the 18F-FDG metabolism images.~   "
154648|NCT01542060|"~     This study is conducted in Asia. The aim of this observational study is to collect efficacy~     and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal~     clinical practice conditions.~   "
154649|NCT01542047|"~     This study is designed to investigate the possibility that use of two similar but distinct~     drugs used together in treatment of advanced cancer might prove less toxic than either agent~     used alone, because dosages can be reduced for each agent. This is a phase I study that is~     designed to measure the frequency and levels of specific side effects when Carboplatin and~     Pazopanib are used in combination in advanced cancer patients. The possibility that~     anti-tumor activity will occur is also going to be investigated.~   "
154651|NCT01542021|"~     Degarelix is an approved drug that is used to treat prostate cancer by lowering testosterone~     levels in the body.~      Degarelix is commonly given with radiation for prostate cancer, but less frequently with~     surgery since there has been no proven benefit with this approach.~      The investigators do not expect the patient to benefit directly from treatment with degarelix~     since their prostate will be removed shortly after the drug is given. Instead, the~     investigators hope to learn about how degarelix and other treatment that lowers your~     testosterone effects prostate cancer cells and use this information to develop better~     treatments in the future.~   "
154652|NCT01542008|"~     Bipolar disorder (BD) is a serious and chronic mental illness that is associated with~     substantial impairment in quality of life and functional outcomes, high rates of suicide, and~     high financial costs. In spite of a proliferation of treatments for BD, nearly half of~     individuals with BD do not benefit from pharmacotherapy because of sub-optimal medication~     treatment adherence. Non-adherence with BD medication treatment dramatically worsens~     outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it~     has been suggested that adherence enhancement might work best if the intervention~     specifically addresses factors that are important and modifiable for a specific individual.~     In spite of the enormity of the problem, the literature on interventions to improve treatment~     adherence is surprisingly limited. There is an urgent need for interventions to enhance~     treatment adherence among BD patients that: 1) are at high risk for future treatment~     non-adherence; 2) may not have access to or interest in long-term, high-intensity, and~     specialized care; and 3) are flexible and patient-focused taking into account reasons for~     non-adherence for a specific individual.~      The proposed study is a first-ever RCT focused specifically on BD treatment adherence~     enhancement, and will test whether a customized adherence enhancement (CAE) psychosocial~     intervention improves adherence and mental health outcomes compared to broadly-directed,~     non-individualized education (EDU). The proposed project has the potential to greatly advance~     the care of BD patients who are at greatest risk for poor health outcomes, with findings~     expected to be generalizable across a variety of treatment settings.~      Hypothesis 1: CAE will be associated with greater improvement in treatment adherence compared~     to broadly-directed, non-individualized BD education (EDU).~      Hypothesis 2: CAE will be associated with improved BD symptoms compared to EDU.~   "
154653|NCT01541995|"~     The study aims to compare the value of contrast medium enhanced post mortem CT to classic~     autopsy.~   "
154654|NCT01541982|"~     The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for~     quality control in intensive care medicine.~   "
154655|NCT01541969|"~     The purpose of this study is to determine whether a new device delivering a sound-based~     intervention (termed acoustic coordinated reset neuromodulation) has significant clinical~     benefit for people with intrusive tinnitus. It is hypothesised that the particular pattern of~     sound stimulation delivered by the device acts to break up patterns of synchronous nerve~     firing in the brain that may be responsible for the sensation of tinnitus. We will also~     measure brain activity in a subset of participants to determine if the intervention results~     in changes in brainwave activity.~   "
154656|NCT01541956|"~     This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional~     study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as~     add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients~     with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.~   "
154657|NCT01541943|"~     The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with~     essential hypertension and hyperlipidemia~   "
154658|NCT01541930|"~     This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate~     malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days~     of treatment.~      The clinical hypothesis is that the success rate is no worse than 70% in the population of~     interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of~     treatment, as assessed by the Study Investigator.~   "
154659|NCT01541917|"~     The purpose of this multi-site randomized clinical trial is to determine if an online coping~     skills training program will produce superior improvements in pain and health-related quality~     of life outcomes for adolescents with JIA relative to outcomes attained with reviewing online~     educational information about JIA.~   "
154660|NCT01541904|"~     The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118~     ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal~     (SAC) and perennial (PAC) allergic conjunctivitis.~   "
154661|NCT01541891|"~     The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic~     solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms~     of mild-to-moderate dry eye syndrome.~   "
154662|NCT01541878|"~     Breast cancer is the most common malignancy affecting women. It is the second leading cause~     of cancer related death in women in many parts of the world. Breast cancer also occurs in~     men, accounting for nearly 1% of the total incidence. As a result of continuing research into~     new treatment methods, women and men with breast cancer now have more treatment options, and~     a better chance of long-term survival than ever before.~      The primary treatment for breast cancer is surgery. Early stage breast cancer, defined for~     the purposes of this registry as newly diagnosed, clinical stage I to IV breast cancer with~     no prior therapy for current disease, is often curable with surgery alone. Reports from the~     National Surgical Adjuvant Breast and Bowel Project (NSABP) and the European Organization for~     Research and Treatment of Cancer (EORTC) longitudinal trials have explored the efficacy of~     various surgical techniques as primary treatment of early stage breast cancer1-7. These~     studies include 20 years of follow-up data that have not shown any significant differences in~     overall survival or in rates of distant recurrences in women who underwent breast-conserving~     surgery with radiation therapy versus those who underwent mastectomy. The results of these~     studies have supported the use of surgery as the standard breast cancer treatment practice~     around the world.~      Data have shown that regardless of the surgical procedure selected for the removal of the~     primary tumor, micrometastases may be present and lead to the development of disease relapse.~     In order to decrease the risk of recurrence, patients may receive various therapies. Systemic~     treatments include chemotherapy and hormonal therapy. Local treatment, such as radiotherapy,~     can also be used to eliminate malignant cells that remain in the breast, chest wall, or lymph~     nodes after surgery.~      The selection of systemic therapy is a complex process, which is based partly on prognostic~     factors such as lymph node status, and predictive factors such as hormone receptor status. A~     number of additional factors are emerging such as HER2/neu overexpression8-10, p53 status,~     histological evidence of vascular invasion, and quantitative parameters of angiogenesis, but~     these await confirmation by further research11. However, patient age, socioeconomic status,~     and availability of treatment options are among a number of other factors that may play a~     role in determining the type of therapy that a patient is offered.~      Over the years, results from a large number of clinical trials have led to the development of~     various guidelines for breast cancer therapy, including the Early Breast Cancer Trialists~     Group (EBCTG) conferences in 199512 and 200013, the 2000 National Institutes of Health (NIH)~     Consensus Conference14, and the 8th St Gallen meeting in 200315. Despite the overview~     analyses and consensus recommendations, detailed information is lacking regarding the actual~     use of the currently available breast cancer treatments. Furthermore, the reasons that~     patients and physicians choose specific therapeutic regimens are not well understood.~      With more than 1.2 million people worldwide diagnosed with breast cancer in 200116, and the~     incidence predicted to increase, making appropriate treatment choices is critical to each~     breast cancer patient's survival, well-being and quality of life. The plethora of available~     scientific and lay information can result in a complex and arduous decision-making process~     for the breast cancer patient and his/her health care provider(s). It is anticipated that~     this registry will assist in the decision-making process by providing up-to-date information~     about treatment patterns.~      STUDY OBJECTIVES The purpose of the study is to collect, analyze, and disseminate data on~     patients with stage I-IV breast cancer. The goal of this registry is to improve patients care~     through a better understanding of treatment patterns and outcomes within individual~     countries, geographic regions, and ultimately, worldwide.~      Primary Objectives:~        -  Characterize the clinical pattern of patients with breast cancer (clinical stage I-IV as~          defined by the AJCC17).~        -  Characterize existing and evolving practice patterns.~        -  Assess patient disease free and overall survival outcomes.~      Secondary Objectives:~        -  Disseminate findings through publication in peer-reviewed scientific journals.~        -  Provide supportive data to the development of standard therapies.~        -  Analyze data and design ancillary studies to address unanswered clinical questions.~   "
154663|NCT01541865|"~     The Study objective is to assess the performance of the Vessix V2 Renal Denervation System~     for the treatment of uncontrolled hypertension using an innovative percutaneous Radio~     Frequency (RF) balloon catheter renal denervation device.~   "
154664|NCT01541852|"~     The main purpose of this study is to determine the effect of Losmapimod on blood vessels in~     patients with Chronic Obstructive Pulmonary Disease (COPD). Although COPD is a lung disease,~     it is also associated with an increased risk of cardiovascular disease (e.g. heart attacks~     and stroke). The investigators believe that this is a result of inflammation within the body,~     which damages the lining (endothelium) and walls of blood vessels. These changes can promote~     the development of fatty deposits within the walls of arteries (atherosclerosis) which can~     rupture and block arteries causing damage.~   "
154665|NCT01541839|"~     The primary objective of this study is to determine if there is a time savings in the~     operating room by using a septal stapler instead of suture in closure of primary septoplasty.~      The secondary objectives are to determine the subjective outcome of patients undergoing~     closure with the septal stapler instead of suture via questionnaire, and to determine if~     there is a difference in postoperative complications between groups.~   "
154666|NCT01541826|"~     The purpose of this project is to determine whether chokeberry polyphenols mitigate~     cardiovascular disease risk in former smokers.~   "
154667|NCT01541813|"~     Chronic iron overload is responsible for morbidity and mortality. There are many genetic and~     acquired causes. One of them is an hepcidin deficiency. Hepcidin is the regulating hormone~     for iron. The study explores this specific cause, and aim to characterize this iron overload~     in term of clinical, biological, genetic and functional specificities.~   "
154793|NCT01540162|"~     EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in~     Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers~     including those on tube feeding tube, diarrhea in children, prophylactics of pathological~     colonization in newborns including premature newborns, and improvement of immunity in~     newborns (mature and premature).~      The aim of this trial was to observe efficacy and safety of Mutaflor® SUSPENSION use for~     immunity improvement in preterm newborn infants~   "
154668|NCT01541800|"~     MicroRNAs are small molecules which have recently been discovered in cells. They are known to~     be responsible for the normal development of cells and when they are disrupted can contribute~     to the development of cancer. Many previous studies have been done evaluating the expression~     of microRNAs in normal tissues as well as a wide variety of cancers.~      Recently, microRNAs from tumor cells have been detected circulating in the blood of patients~     with cancer. This presents a novel opportunity to use microRNAs in the blood as an early~     predictor of cancer as well as a marker of response to therapy. No previous studies have been~     performed evaluating microRNAs in the blood or cerebrospinal fluid of patients with childhood~     cancers. We propose a feasibility study to evaluate the presence of microRNAs in the blood~     and cerebrospinal fluid of patients with central nervous system tumors, leukemia and lymphoma~     who are currently on chemotherapy and undergoing blood draws, lumbar punctures and/or~     reservoir taps for routine clinical care. If we're able to identify circulating microRNAs in~     this population of pediatric patients, we will build upon this data in proposing a future~     study.~   "
154669|NCT01541774|"~     The purpose of this study is to evaluate the procedural safety and effectiveness of the~     Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic~     lesions located in the native peripheral arteries. The Phoenix Atherectomy™ System is~     intended for use in atherectomy of the peripheral vasculature. The intended peripheral~     vessels include the Superficial Femoral, Popliteal, and Infrapopliteal arteries. The system~     is not intended for use in the coronary, carotid, iliac or renal vasculature. The results of~     this study will be used to support a 510(k) submission to the Food and Drug Administration.~   "
154670|NCT01541761|"~     The proposed study is a randomized controlled trial to test the effectiveness of a primary~     care, family-centered child obesity prevention program beginning in pregnancy and continuing~     throughout the first three years of life compared to routine standard of care. The study aims~     to reduce the prevalence of obesity at age three, improve child diet composition and healthy~     lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center~     serving primarily low-income immigrant Latino families. The intervention Starting Early~     will consist of three components. 1) Family Groups: interactive groups coordinated with the~     child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2)~     Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated~     into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum~     from the family groups.~      Hypothesis: Compared to controls, the intervention group will show reduced obesity and~     improved parent feeding knowledge and increased healthy feeding attitudes, styles and~     practices~   "
154671|NCT01541748|"~     This study is a prospective, single arm, multi-center, post-market study to evaluate the~     efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and~     posterior) pelvic organ prolapse repair.~   "
154672|NCT01541735|"~     The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in~     drug-naïve patients with type 2 diabetes.~   "
154673|NCT01541722|"~     The primary purpose of the proposed study is to characterize the oxidative stress and~     inflammatory cytokine status in UCD during baseline and decompensated states.~   "
154674|NCT01541709|"~     KIT exon 9 mutants had poorer survival compared with KIT exon 11 mutants when they were~     treated with the same dose of imatinib, 400 mg per day, and that patients with KIT exon 9~     mutation had better progression-free survival with imatinib treatment at an escalated dose,~     800 mg per day, than with imatinib treatment at a dose of 400 mg per day.10,11 Based on the~     results, imatinib 800 mg per day is now considered the standard dose for the treatment of~     patients with metastatic or unresectable GIST showing KIT exon 9 mutation in Western~     countries.~   "
154675|NCT01541696|"~     The broad objective is to improve zinc status in older infants and young children who are at~     risk of zinc deficiency because of combination of inadequate dietary zinc intake and high~     rates of diarrhea. As a sub-study within larger RCT using zinc fortified Sprinkles, the~     proposed study will measure the amount of zinc absorbed from a test meal of typical~     unfortified complementary foods consumed by Pakistani infants, or the same complementary~     foods fortified by the addition of the Zn-containing Sprinkle.~   "
154676|NCT01541683|"~     The investigators aim is to study the efficacy of mentholyptus drops in improving the~     palatability of PEG-electrolyte solution used in bowel cleansing for colonoscopy. The study~     is a randomized controlled trial which will include patients undergoing elective colonoscopy~     at the American University of Beirut Medical Center. Patients will be randomized into one of~     two study arms using a computer generated randomization list. Patients assigned to the~     intervention arm will be asked to have candy (Halls®) during the whole 2 hours period while~     drinking the PEG solution unlike the control arm patients who will only receive the PEG~     solution. All patients will then be evaluated for the tolerability of the preparation while~     taking into account the palatability of the solution as main outcome and the remaining volume~     of the PEG solution and side effects as secondary outcomes.~   "
154677|NCT01541670|"~     The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in~     subjects with lupus nephritis.~   "
154678|NCT01541657|"~     The purpose of this study is to determine the effect of 3 types of sensory-targeted~     rehabilitation interventions on subjective and objective measures of function for those with~     chronic ankle instability. The investigators hypothesize that subjective and objective~     measures of function including self-reported disability, balance, and range of motion will~     improve after 2-weeks of sensory-targeted interventions.~   "
154679|NCT01541644|"~     Patients are asked to be in this study if they have multiple myeloma and are having tingling,~     numbness and pain from taking bortezomib (velcade®). Patients who have been diagnosed with~     multiple myeloma often take bortezomib (velcade®).~      This research is being done to find out if acupuncture can reduce the nerve pain, tingling,~     and/or numbness patients experience due to bortezomib (velcade®).~      Acupuncture is a medical technique of inserting very thin needles into the energy points on~     the body with the aim to restore health and well-being. It has been used widely to treat~     pain, such as lower back pain and nerve pain. In this study we will see if acupuncture can be~     used to ease nerve pain and tingling, numbness that is caused by bortezomib.~   "
154794|NCT01540149|"~     The purpose of the registry is to assess workload of a Home Monitoring based follow up for~     Biotronik implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy~     defibrillators (CRTD) patients.~   "
154680|NCT01541631|"~     In this study, it is hypothesized that helminth infections modulate immune responses against~     HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS and~     increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of~     helminth infections on progression of HIV-1 infection is dependent on helminth infection~     intensity, host background immunity, nutritional status, demographic factors and~     socio-economic status. Also, treatment of helminth infections using praziquantel and~     albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads,~     improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and reduction~     of episodes of HIV-1 related opportunistic infections. In addition, HIV-1 infection is~     associated with poor anthelminthic treatment outcome as compared to non-HIV infected~     individuals~   "
154681|NCT01541618|"~     The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients~     before and after beginning Natalizumab.~   "
154682|NCT01541605|"~     This study aims at evaluating the efficacy and safety of methylphenidate in the initial~     treatment of acute mania in patients with bipolar affective disorders.~   "
154683|NCT01541592|"~     It has been shown that intravenous fatty acids given to normal volunteers in the form of~     heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is~     not known if this same phenomenon can be demonstrated with oral fat. The investigators are~     specifically interested in whether or not there are differences in the induction of insulin~     resistance between the 3 main classes of fatty acids (saturated, monounsaturated and~     polyunsaturated).~      The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of~     which frequently accompany insulin resistance.~   "
154684|NCT01541579|"~     The current multicentre phase III study is proposed to confirm in an add-on therapy design~     compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from~     healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease~     over a 24-week period and an extended follow-up period up to 104 weeks.~   "
154685|NCT01541566|"~     The purpose of this study is to assess whether, in patients at high cardiovascular risk~     (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most~     effective when based on home blood pressure telemonitoring and on the feedback to the patient~     by the doctor between visits, or when based only on blood pressure determination during~     quarterly office visits.~   "
154686|NCT01541553|"~     The purpose of this trial is to compare the rate of complete clearance of actinic keratosis~     (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy~     alone.~   "
154687|NCT01541540|"~     This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects~     will continue with their prescribed medications. Our main objective is to assess whether~     preventive e-counseling (provided through a website of the Heart and Stroke Foundation)~     improves blood pressure and cardiovascular risk status over a 12-month interval. REACH will~     also evaluate improvement in lifestyle behaviors that include diet, exercise, smoking, and~     adherence to prescribed medications. Finally, we will quantify the amount of e-counseling~     support that is required during REACH to evoke a significant reduction in blood pressure. It~     is hypothesized that e-Counseling (vs. Control) will significantly improve blood pressure and~     lifestyle behaviours at the 12-month assessment. The findings of this trial will provide~     information that is critical to our understanding of how internet-based programs can help to~     improve blood pressure and to reduce the risk for cardiovascular disease.~   "
154688|NCT01541527|"~     Antibodies (Abs) directed against factorVIII (FVIII) remain the main iatrogenic complication~     in haemophilia A (HA) patients. Anti-FVIII Abs inhibiting pro-coagulant properties of the~     molecule are named inhibitors whereas Abs directed towards non-functional epitopes are named~     non-neutralizing antibodies (NNA). These NNA are poorly studied and their prevalence is~     ill-defined.~      In a recent retrospective study the investigators evaluated, in a cohort of 210 patients~     without inhibitor, the NNA prevalence and the NNA epitope specificity against the heavy chain~     (HC)or the light chain(LC). For the first time, the investigators used two x-MAP based~     assays: the first to determine the specificity of anti-FVIII Abs against the HC or the LC,~     the second to display Abs directed towards the B domain. NNA were found in 38 out of 210~     patients (18).~      Among this NNA positive population, 74% and 13% of patients had anti-FVIII Abs against both~     chains. The proportion of NNA directed towards the B domain was 18%.~      Considering an approximate inhibitor prevalence of 30% and a NNA prevalence of 19% in severe~     HA patients, approximately 50% of severe HA patients develop an immune response against~     infused FVIII. Due to their unclear relevance, the NNA detection does not yet belong to the~     routine clinical practice.~      However, in 2006, Dimichele advancedf a hypothesis concerning the influence of NNA on the~     variations in the kinectics of FVIII observed in certain patients.~      The mechanism explaining the role of these NNA in the FVIII in the FVIII kinectics has not~     still been demonstrated.~      The investigators propose to perform a multicentre prospective study with the aim to confirm,~     in severe, moderate and mild HA treated patietns, the NNA prevalence observed in our~     retrospective study, to study the evolution over time of the epitopemapping of these NNA and~     to explore the correlation between these NNA and clinical/biological parameters.~   "
154689|NCT01541514|"~     The overall purpose to the study is to prospectively study how often patients with and~     without acute lung injury (ALI) have patient-ventilator asynchrony demonstrated as stacked~     breaths. The investigators seek to describe the quantity of stacked breaths by continuously~     recording flow, volume, and pressure waveforms routinely displayed on the vent. The~     investigators also seek to describe how primary ICU teams manage asynchrony documenting~     interventions of sedation or vent manipulation and what modality is most successful.~   "
154690|NCT01541501|"~     Study wants to compare central corneal thickness (CCT) obtained through 3 different~     no-contact instruments and to compare them with contact ultrasound pachymetry, actually the~     gold standard technique.~   "
154691|NCT01541488|"~     Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses~     of BI 1021958 tablets in healthy male volunteers (first-in-human trial)~   "
154692|NCT01541475|"~     The current study is being conducted in patients with major depression. The study aims to 1)~     investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and~     bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue,~     hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes~     using magnetic resonance imaging (MRI), 3) and examine a relationship between the~     improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.~   "
154795|NCT01540136|"~     This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT~     chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.~   "
155142|NCT01535599|"~     The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic~     Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the~     treatment of acute otitis externa (AOE).~   "
154693|NCT01541462|"~     Patients requiring the use of artificial ventilation (also called mechanical ventilation) for~     more than 21 days account for more than 37% of all ICU costs. As such, these patients are now~     transferred to centers that specialize in weaning patients from the respirator; these units~     are referred to as long-term acute care (LTAC) facilities. Despite the increase of LTAC~     facilities, research on the fastest method for disconnecting the patient from the respirator~     is lacking. In addition, little information is available regarding the long-term survival and~     quality of life after a prolonged course of artificial ventilation. The purpose of this study~     is to determine the fastest method for disconnecting the patient from the respirator at a~     LTAC facility and its effect on long-term survival and quality of life.~   "
154694|NCT01541449|"~     The investigators think that there is a connection between the use of plaquenil and the~     prevention of Age related macular degeneration (AMD). The investigators believe that the use~     of plaquenil makes bruch's membrane thicker, thereby preventing Chroidal Neovascularization~     (CNV) growth.~   "
154695|NCT01541436|"~     This research is being done because pain is a significant problem for patients with a variety~     of medical problems and following surgery or traumatic injury. Currently available pain~     medications may not relieve all types of pain or may relieve pain only at doses that produce~     side effects and potential complications.~      Although Remote Ischemic Preconditioning (RIPC) appears promising, there remain several~     unanswered questions about how it works. This research trial will help determine how RIPC may~     activate the bodies natural pain control system. The goals of this study are to see if RIPC~     has any effect 1) on a small area of skin that will be expose to a small amount of UV- B~     radiation (a mild sunburn), 2) on acute thermal heat temperatures that will be applied to~     skin, and 3) on the sunburn-like sensation to light touch after putting capsaicin cream (the~     active ingredient in hot chili peppers) on skin.~      Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood~     pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then~     deflated and blood flow resumes. The process is repeated up to three times. This procedure~     causes the body to increase its natural pain relief system that may help to decrease the~     amount of postsurgical pain.~   "
154696|NCT01541423|"~     This observational (non-interventional) study is being conducted to characterize the safety~     and use of CINRYZE in routine clinical practice when administered for (1) routine prevention~     of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3)~     treatment of angioedema attacks.~   "
154697|NCT01541410|"~     The purpose of this feasibility study is to investigate the clinical performance of the~     Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the~     thoracic aorta.~   "
154698|NCT01541397|"~     Prospective study to compare the bone mineral density in adults with HPA on KUVAN™ therapy to~     those not on therapy. The investigators hypothesize that after one year of KUVAN™ therapy,~     there will be an improvement in their bone mineral density.~   "
154699|NCT01541384|"~     Novel wireless technology has created inexpensive tools that allow both accurate monitoring~     of adherence to pills as well as real-time interventions such as automated reminders in the~     event of a missed dose. In this study, the investigators will use Vitality GlowCaps, an~     electronic pill bottle. These pill bottles provide an unbiased assessment of pill bottle~     opening and a valid approach to verifying self-administered pill taking, reflecting not only~     daily use but also patterns of drug use and timing. At the prescribed times, bottle will~     electronically transmit whether a subject opened the pill cap to take the immunosuppressant~     medication via a built-in transmitter to the central server. The investigators will randomize~     participants to usual care, customized reminders, and customized reminders paired with~     provider notification in the event of low adherence.~      The investigators' aim: To improve immunosuppression (IS) medication adherence in kidney~     transplant recipients.~      The investigators' hypotheses: a) Automated reminders will improve adherence to~     immunosuppression compared to usual care, and b) Automated reminders, paired with provider~     notification about patients with poor adherence, will improve adherence to immunosuppression~     compared to usual care.~   "
154700|NCT01541371|"~     The purpose of this study is to evaluate the effectiveness of paliperidone extended-release~     (ER; designed to slowly release a drug in the body over an extended period of time) tablets~     in participants with schizophrenia (psychiatric disorder with symptoms of emotional~     instability, detachment from reality, often with delusions [a false belief held in the face~     of strong differing evidence, especially as a symptom of psychiatric disorder] and~     hallucinations [imagining things], and withdrawal into the self) who were not satisfied with~     other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute~     psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine,~     quetiapine and risperidone) they had been taking. The safety and tolerability of paliperidone~     ER tablets will also be assessed.~   "
154701|NCT01541358|"~     This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography~     (PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnostic~     procedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bone~     cancer~   "
154702|NCT01541345|"~     Since there are no clinical studies available comparing the gold standard (autogenous bone~     graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded~     with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the~     present exploratory study has been designed.~      The aim of the present study is therefore to test whether or not the application of a~     xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and~     histologically similar outcomes as the gold standard (autogenous bone block) for the~     regeneration of chronic ridge defects.~      The investigators expect that there is no difference in bone quantity and quality between the~     two methods and that the use of the test treatment will be more user and patient friendly~     according to the patient perception/acceptance since no second surgical site will be~     necessary as well as cause less complications.~   "
154807|NCT01539967|"~     Obesity is a worldwide health problematic whose incidence is increasing especially in~     developed countries. The surgical management of this illness consists in different techniques~     such as Laparoscopic Sleeve Gastrectomy but this treatment could not be efficient enough. The~     causes of failure after Laparoscopic Sleeve Gastrectomy are not known but could include the~     residual gastric volume.~      The aim of the present study was to determine whether the residual gastric volume is involved~     in Laparoscopic Sleeve Gastrectomy's failure.~   "
154703|NCT01541332|"~     The purpose of this clinical research study is to evaluate the safety and effectiveness (good~     and bad effects) of a combination of three different drugs, pomalidomide, pegylated liposomal~     doxorubicin, and dexamethasone when used to treat relapsed (the disease came back) or~     refractory (the disease did not respond to past treatment) multiple myeloma. Different~     dosages (amount of study drug) of pomalidomide are first being tested to determine if there~     are any side effects or risks associated with combining this study drug with the other two~     listed. Once the optimal dose is decided on, the study will change its focus to determining~     the effectiveness of the study drug in this combination.~   "
154704|NCT01541319|"~     A large multicenter randomized controlled trial of approximately 1700 critically ill~     patients' status post complex cardiac surgery with sternotomy, called the Red Cell Storage~     Duration Study (RECESS), is currently ongoing. In the RECESS trial, study groups are~     randomized to either RBCs of less than or equal to 10 days storage time or to greater than or~     equal to 21 days. The primary outcome of RECESS is a change in multiple organ dysfunction~     score. Secondary outcomes in RECESS include all cause 28-day mortality, mechanical~     ventilation free days, and other clinical outcomes. The RECESS study presents a unique~     opportunity to investigate mechanisms associated with RBC storage duration in the context of~     clinical outcomes for well-characterized surgical study groups. The ancillary study described~     here is called the Mechanism and Repository Study (MARS) for RECESS.~      The MARS study will analyze the most commonly reported and hypothesized mechanisms considered~     to be associated with the RBC storage lesion and adverse outcomes in critically ill patients.~     Laboratories with expertise in RBC function, nitric oxide mechanisms, the coagulation~     cascade, microparticle analysis and immunology will each examine hypotheses addressing~     mechanisms potentially able to relate storage time to clinical outcomes in RBC transfusion~     recipients. At the conclusion of the study, the results will provide a much better~     understanding of how RBC storage age affects recipient RBC function, coagulation parameters,~     microparticle load and immune modulation. Perhaps most importantly, this study will also~     develop a large sample repository for future analysis.~   "
154705|NCT01541306|"~     Achondroplasia and hypochondroplasia are the most common forms of dwarfism. Recent studies~     have shown that a small hormone called C-type natriuretic peptide (CNP) is an important~     regulator of linear growth. The investigators believe that genetic abnormality that causes~     achondroplasia and hypochondroplasia also disrupts CNP signaling, which may contribute to the~     growth problem. The investigators propose to look at levels of this and other closely related~     hormones in children and adults with achondroplasia or hypochondroplasia to see if they are~     different from levels in healthy people. The investigators hypothesis is that CNP levels are~     elevated in children with achondroplasia or hypochondroplasia, compared the healthy~     population. Another hypothesis is that CNP levels are not elevated in adults with~     achondroplasia or hypochondroplasia, since adults have no growth-plate cartilage. By studying~     the potential role of the CNP system in achondroplasia and hypochondroplasia, not only will~     the investigators provide further insight into the pathophysiology of these common syndromes,~     the investigators will also provide greater insight into the regulation of normal linear~     growth.~   "
154706|NCT01541293|"~     This is a study to investigate whether instilling a small amount of liquid lidocaine into the~     uterus will decrease pain felt by women during laminaria insertions done for cervical~     dilation prior to second trimester abortion.~      The investigators hypothesize that women who receive intrauterine lidocaine in addition to a~     paracervical block will experience less pain than women who receive only a paracervical~     block.~   "
154707|NCT01541280|"~     Patients included in the study with high risk acute myeloid leukemia or myelodysplastic~     syndrome as defined will receive an allogeneic transplantation conditioned by either~     myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive~     a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with~     donor lymphocyte infusion.~   "
154708|NCT01541267|"~     The main purpose of the study is to compare the effects of three different types of RAAS~     blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.~   "
154709|NCT01541254|"~     The purpose of this study is to evaluate the safety and probable benefit of the Low-profile~     Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when~     used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with~     bare platinum embolization coils.~   "
154710|NCT01541241|"~     THE AIM OF THE this study is to assess the hemodynamic changes of uterine artery in patients~     with CIUD induced bleeding by using transvaginal color Doppler indices (uterine artery~     resistance index and pulsatility index) to prove the relationship between these changes and~     bleeding in these patient .~   "
154711|NCT01541228|"~     Aim of the study: To evaluate clinical effectiveness of two different light doses when~     treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.~   "
154712|NCT01541215|"~     This trial is conducted globally. The aim of this trial is to assess the efficacy and safety~     of liraglutide in the paediatric population in order to potentially address the unmet need~     for treatment of children and adolescents with type 2 diabetes.~   "
154713|NCT01541202|"~     The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of~     heart failure.~   "
154714|NCT01541189|"~     To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.~   "
154715|NCT01541176|"~     The main objective of this study is to demonstrate that the absence of post-transplantation~     corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical~     reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy~     that includes standard oral corticosteroids.The secondary objectives of the study consist to~     compare on various parameters (fibrosis progression, renal function, dialysis, ratio of~     proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival, clinical~     and biological tolerance) therapy with no corticosteroids post-transplantation in comparison~     to standard immunosuppressive treatment strategies including oral corticosteroids. Secondary~     objectives of the study consist also to compare the two techniques for assessing fibrosis by~     numerical reading and by centralized blinded reading of the treatment group (by 2 anatomical~     pathologists).~   "
155192|NCT01534936|"~     This is a noninterventional observational study lead amongst psychiatrists, to assess the the~     overall status of schizophrenic outpatients with affective symptoms treated with atypical~     antipsychotics.~   "
154716|NCT01541163|"~     Although cardio-embolic etiology of ischemic stroke (IS) is largely respected, there is still~     no clear recommendation for routine complex cardiological examination in all IS patients.~     Using complex cardiological examination the investigators expect:~        1. more accurate detection of patients with concomitant heart disease (cardiac rhythm~          disorder, valve disorders, acute coronary syndrome, cardiac thrombus and myxoma, atrial~          and ventricle septum defects)~        2. higher number of etiologically determinated IS, which is crucial for accurate secondary~          prevention.~   "
154717|NCT01541150|"~     Pedophilic behaviors represent a public health problem with serious consequences. The~     investigators hypothesize a disruption in the decision-making strategies among sex offenders~     pedophiles. Highlight this type of abnormality would offer a specific treatment of a possible~     neuropsychological deficit (with cognitive remediation for instance) and perhaps avoid~     recurrences of this type of behavior.~   "
154718|NCT01541137|"~     The investigators investigated whether a strictly controlled pain management with patients~     participating in a clinical study can attenuate persistence of post-thoracotomy pain. The~     investigators also wanted to find out whether NSAID + intravenous patient-controlled~     analgesia with morphine is an efficacious alternative to thoracic epidural analgesia.~   "
154719|NCT01541124|"~     Background and Objectives:~      The drugs used as recommended by the WHO does not promote pain relief for all patients with~     cancer pain. The objective of this study was to evaluate the use of morphine as the first~     drug for the treatment of moderate cancer pain by visual analogue scale in patients with~     advanced disease and / or metastases, as an alternative to the recommendations of the WHO~     analgesic ladder advocated. Methods: The patients without opioid therapy with more than 18~     years, were randomly divided into two groups. G1 patients received medication according to~     the analgesic ladder, starting treatment with non-opioid in the first step, the second weak~     opioid and opioid potent in the third, and G2 received morphine as first analgesic. There was~     evaluated the efficacy and tolerability of initial use of morphine every 2 weeks for 3~     months. Results: The study was performed in 63 patients. The groups had similar demographics.~   "
154720|NCT01541111|"~     This study is an evaluation of the analgesic effect of magnesium associated with morphine in~     patients with cancer pain.~   "
154721|NCT01541098|"~     This is a multi center, phase 2 randomized controlled study to determine the effect of~     lyophilized plasma in patients on warfarin therapy.~   "
154722|NCT01541085|"~     The purpose of this study is to study the kinetics (study of the rate of change) of immune~     recovery quality and function in stored plasma blood samples of treatment-naive (not~     previously treated with antiretroviral drugs) patients with advanced human immunodeficiency~     virus (HIV) infection starting a Darunavir/Ritonavir- or Efavirenz-based highly active~     antiretroviral therapy (HAART) regimen.~   "
154723|NCT01541072|"~     The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution~     after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell~     malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral~     stem cell transplantation.~   "
154724|NCT01541059|"~     The main objective of this study is to demonstrate the superiority of local analgesia with~     ropivacaine versus placebo on postoperative pain during the first 24 hours following~     bilateral surgery of all four third molars under general anesthesia.~   "
154725|NCT01541046|"~     Infantile colic is a common medical condition which remains a frustrating problem for parents~     and health care providers with no clear treatment guidelines. To fill the void in existing~     literature, we present a protocol to examine whether probiotics are effective in decreasing~     infantile colic symptoms when compared to placebo treatment.~      We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce~     symptoms of infantile colic in breastfed infants in comparison to placebo.~      An interim analysis will be conducted after 50 infants randomized to monitor both safety and~     efficacy.~   "
154726|NCT01541033|"~     The purpose of this study is to identify biomarkers in this subset of autism patients, design~     a protein based assay system for screening serum for these biomarkers and confirm that these~     serum antibodies are still present at one year's time.~   "
154727|NCT01541020|"~     Proprioceptive weighting changes may explain differences in postural control performance. In~     addition, the respiratory movement has a disturbing effect on postural balance. Postural~     balance seems to be impaired in individuals with respiratory disorders. Besides the essential~     role of respiration, the diaphragm may also play an important role in the control of the~     trunk and postural balance. Deficits in proprioception are found in a subgroup of patients~     with low back pain. In addition, disorders of respiration have been identified as strongly~     related to low back pain.~      The aim of the study is to clarify whether loading of the inspiratory muscles has a negative~     effect upon proprioceptive postural control in healthy individuals and individuals with~     recurrent low back pain.~   "
154728|NCT01541007|"~     Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men~     with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic~     Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost one in 4~     patients treated with Cabazitaxel in this study required dose reductions or dose delays or~     stopped treatment due to toxicity. ConCab examines another scheduling for cabazitaxel to see~     if we can improve tolerability so that patients will receive a higher percentage of the~     treatment as planned.~   "
154729|NCT01540994|"~     The purpose of this study is to evaluate a short course (five radiation treatments) of very~     focused (stereotactic) external beam radiation therapy for the treatment of early stage~     prostate cancer.~   "
154730|NCT01540981|"~     The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction~     with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury~     (DTI) progression to advanced stage pressure ulcers.~   "
154731|NCT01540968|"~     The purpose of this study is to investigate the effect of a combined treatment of nutritional~     therapy and physical exercise in palliative cancer out-patients. The investigators~     hypothesize that this combined intervention consisting of an increased energy- and protein~     intake and physical exercise level improves quality of life (QoL), functional and clinical~     status.~   "
158546|NCT01490814|"~     Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon~     catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with~     paroxysmal atrial fibrillation.~   "
154732|NCT01540955|"~     There are over 2 million breast cancer survivors in the US today. Along with extended~     survival, many women experience short and long-term after effects of treatment, which may~     decrease their quality of life and contribute to other health problems. Cognitive~     complaints---difficulties with memory, concentration, and planning—are commonly reported~     after adjuvant treatments for breast cancer. This study is designed to test the efficacy of a~     5 week group-based cognitive rehabilitation intervention on improving cognitive complaints~     and test performance, in comparison to women who will receive the same intervention at a~     later time (wait-list control). Women will also have an EEG test performed before and after~     the intervention program to see if improvements in cognitive complaints and performance can~     be documented by examining the EEG.~   "
154733|NCT01540942|"~     The study was aimed to determine whether perioperative nutrition treat and(or)the~     perioperative disease activity were associated with postoperative recurrence and~     complications after bowel resection for Crohn's disease.~   "
154734|NCT01540929|"~     This is a retrospective study of the Department of Defense (DoD) Smallpox Screening Form 600s~     (SF600s) generated during screening of service members for possible immunization with the~     ACAM2000® smallpox vaccine.~      Primary Objective:~        -  To evaluate the accuracy of the DoD smallpox vaccination screening process in military~          personnel.~      Secondary Objective:~        -  To describe the number of subjects who are excluded from vaccination, stratified by the~          pre-defined categories for exclusion (separately for the Screened and Evaluable~          Populations).~   "
154735|NCT01540916|"~     Alterations of acid-base equilibrium are very common in critically ill patients. Thus,~     understanding their pathophysiology and the possible compensatory mechanisms acting in~     different organs may play an important role in better set the consequent clinical treatment.~     The lung and the kidney are the two principal actors of such regulations. Although the~     respiratory response to acid-base alterations is well understood, less information are~     available for what the renal system is concerned. Such lack of information is partially due~     to: 1) the historical consideration of the kidney as a slow organ, in response to~     variations in acid-base equilibrium; 2) the lack of a monitoring system to closely assess~     renal response.~      Our group has recently developed a monitoring system aimed at analyzing, in a~     quasi-continuous and non-invasive manner (every 10 min) the urinary profile in terms of~     urinary pH and electrolyte concentrations (sodium, potassium, chloride, ammonium).~      The investigators hypothesize that the renal system reacts to large as well as to minimal~     variations of the acid-base equilibrium (especially induced by a variation in the respiratory~     function) in a very fast way, modifying the urinary concentration (and therefore the urinary~     excretion) of ammonium and some electrolytes (especially chloride).~   "
154736|NCT01540903|"~     The proposed trial will evaluate whether relatively non immune populations in endemic~     countries can be effectively infected with aseptic, purified, cryopreserved sporozoites~     (PfSPZ Challenge) given intradermally.~   "
154737|NCT01540890|"~     Main of the study is to assess the influence of high-dose opioids on the sleep architecture~     and patterns of breathing using non-invasive polysomnographic measurements before and after~     opioid withdrawal in patient who undergo opioid withdrawal independently from the present~     study. These data will be compared to polysomnographic data of patients under opioid~     treatment who do not undergo opioid withdrawal as well as to patients without opioid~     treatment.~   "
154738|NCT01540877|"~     Main of the present study was to develop a model of concomitant C-fibre block and~     sensitization eliciting spontaneous pain as well applying topical capsaicin and local~     anesthetics (LA) to examine the sensory alterations after combined C-fiber block and~     sensitization in both different application orders (sensitization of blocked C-fibers and~     block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect~     stronger sensory changes during the combined substance application than during the~     monoapplication. We expect also contralateral sensory alterations mirroring the changes on~     the intervention site after the combined capsaicin and LA application, being stronger than~     after sensitization alone absent after C-fiber block alone.~   "
154739|NCT01540864|"~     The purpose of this study is to compare the safety and effect of HPP404 versus placebo on~     body weight in overweight or obese subjects.~   "
154740|NCT01540851|"~     The objectives of this research are to:~      Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing~     primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). The trial will~     compare a Care Navigator post-discharge intervention versus Usual Care post discharge~     management of patients undergoing TKA. The intervention will focus on the challenging process~     of transitions from the acute care hospital to inpatient or outpatient rehabilitation, and~     from inpatient rehabilitation to home.~      The principal goals of the trial are:~        1. To establish whether Care Navigator intervention improves functional outcomes as~          compared with the Usual Care treatment six months after TKA surgery.~        2. To establish whether Care Navigator intervention is cost effective six months after~          TKA surgery.~      The investigators hypothesize that:~        1. Incorporating the Care Navigator role into the Usual Care treatment will increase TKA~          patients' rate of adherence to the rehabilitation protocol and improve functional~          outcomes.~        2. Addition of a Care Navigator is cost-effective.~   "
154741|NCT01540838|"~     The main purpose of this trial is to test if mortality of childhood bacterial meningitis can~     be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional~     bolus administration four times daily (qid), combined with high-dose paracetamol orally, when~     both treatments are executed for the first 4 days. The series will be collected at Hospital~     Pediátrico David Bernardino, Luanda, Angola.~      The recruitment of patients begins, the conditions permitting, in early 2012. The criteria~     for patient participation is a child at the age of 2 months to 15 years who presents with the~     symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is~     performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.~   "
154742|NCT01540825|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 113608 in healthy male volunteers following oral administration of single rising doses.~      A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single~     dosing.~   "
155315|NCT01533285|"~     The purpose of this study is to explore the effect of an inflammatory and a psychosocial~     stressor and the combination thereof on mood in healthy young and elderly participants and~     patients with Major Depressive Disorder (MDD).~   "
154743|NCT01540812|"~     Trial protocol intended the optimization of induction treatment with:~        1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation.~        2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of~          high doses of anthracyclines has not brought higher response rates or longer duration~        3. Replacing the poor cytological response at day 14 by the level of ER at the end of~          induction as a criterion to decide the further treatment (consolidation or second~          induction), so as to have only one criterion (the ER) throughout the study to decision~          making.~      For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity~     during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a~     more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2)~     in patients with ALL-T, since there is recent evidence of a higher response rate with this~     strategy.~      Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate~     level of ER after two cycles of induction or in those patients who required two courses of~     induction and have obtained proper ER after the second.~      Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards,~     to avoid bias in making treatment decisions~   "
154744|NCT01540799|"~     The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine~     ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache~     symptoms and migraine frequency in high disability migraineurs.~   "
154745|NCT01540786|"~     This study aims to identify differences in bladder contractions during the storage phase (non~     voiding activities) between OAB subjects and healthy subjects, using high resolution~     urodynamics.~      The study is divided into two parts:~        -  PART 1: Consists of 5 females with overactive bladder~        -  PART 2: Consists of 25 females with overactive bladder and 15 healthy females~      Part 1 subjects will be enrolled followed by part 2 subjects. The data from part 1 subjects~     will be reviewed and analysed by a group of experts before starting the second part (part 2)~     of the study.~   "
154746|NCT01540773|"~     The purpose of the study is to confirm the results of a prior study that demonstrated pills~     containing two amino acids which are in foods increased growth hormone and insulin-like~     growth factor-1.~   "
154747|NCT01540760|"~     This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose~     study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy~     volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15~     and 29.~   "
154748|NCT01540747|"~     To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF)~     outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).~   "
154749|NCT01540734|"~     A single dose pharmacokinetic study investigating two paracetamol formulations~   "
154750|NCT01540721|"~     This study will evaluate the pharmacokinetic profiles of experimental formulations of~     paracetamol.~   "
154751|NCT01540708|"~     The purpose of this study is to optimise the device and/or formulation of the Fluticasone~     propionate (FP)/salmeterol (SALM) unit dose powder inhaler (Rotahaler) to achieve drug~     delivery characteristics comparable to the Fluticasone propionate /salmeterol DISKUS inhaler.~     The indication is asthma and chronic obstructive pulmonary disease. The study is an~     open-label, randomised, cross-over, single centre study in healthy volunteers and will be~     conducted in a maximum of 3 parts, A, B and C. The design is adaptive and pharmacokinetic~     (PK) data analysis follows each part to enable a decision on whether progression to the~     subsequent parts is required.~      Part A of the study will test an alternative version of the Rotahaler with a low airflow~     resistance. The study will then test one or more of the following options depending on the~     outcome of part A. If progressed, part B will test modified Rotacap formulations including:~     (1) modified blend formulation, (2) reduced capsule fill weights, (3) different capsule~     types. Part B will also test other versions of the Rotahaler with intermediate airflow~     resistance. Part C will test the lower strength FP/salmeterol (100/50 mcg or lower) and/or a~     new unit dose DPI device (BUDI).~      A total of 36 subjects will be enrolled in each part to ensure 32 complete. In each~     cross-over arm, subjects will be administered 7 doses (3.5 days bid) with PK sampling~     following administration of the 7th dose. A three-day minimum wash-out period will separate~     each cross-over arm.~   "
154752|NCT01540695|"~     This prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims to~     determine whether:~        1. The process of cryofixation prior to generating formalin fixed paraffin embedded (FFPE)~          H&E sections alters the histology in skin tumor specimens.~        2. Which specific histologic parameters are altered between previously cryofixed versus~          routine FFPE sections. Histologic observations will be recorded by two~          dermatopathologists and two Mohs surgeons and statistically analyzed.~   "
154753|NCT01540682|"~     This study will evaluate the initial safety and effectiveness of an investigational drug,~     MLN8237, added to routine radiation therapy and cetuximab in patients with head and neck~     cancer. This study will also determine the highest dose of MLN8237 that can be given together~     with cetuximab and radiation therapy without causing severe side effects.~   "
154754|NCT01540669|"~     The aim of the study is to test the effect of polydextrose on whole gut transit time and~     gastrointestinal symptoms in a dose-responsive manner.~   "
154755|NCT01540656|"~     During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in~     pressure was observed in the external urethral sphincter along with an increase in bladder~     capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve~     Stimulation (TMNS) in women could induce pressure increment of the external urethral~     sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33~     women suffering from urinary stress incontinence were able to contract their pelvic floor~     muscles and had become free of symptoms. Another pilot study has shown promising effect on~     the overactive bladder syndrome. Furthermore pilot studies in men who are incontinent after a~     radical prostatectomy have shown promising results. A randomized investigation of TMNS~     applied in the immediate period after a radical prostatectomy to investigate effects on both~     continence and erectile function is on going.~      The present study aims to treat urinary incontinence in men who are still incontinent more~     than 1 year after a radical prostatectomy. A medical vibrator is used daily for a period of 6~     weeks and the results of the treatment is then evaluated. The participants will be randomized~     to 2 groups. Group 1 starts vibration treatment at base line and group 2 starts after 6 weeks~     when group 1 is done. The groups are compared at baseline, at 6 weeks and at 12 weeks.~      The stimulation will be performed at the frenulum of the glans penis every day for 6 weeks~     with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis~     of questionnaires, micturition diaries and diaper tests.~      If the investigators are able to demonstrate a significant reduction in the incontinence~     symptoms in the subjects the investigators asses that vibration can be a way of~     reestablishing normal continence in men after a radical prostatectomy.~   "
154757|NCT01540630|"~     This is a double-blind, randomized withdrawal study comparing CNV1014802 with placebo in~     patients with trigeminal neuralgia who have successfully responded to CNV1014802 in an~     initial open-label phase.~      Patients will participate in an initial open-label treatment period of 21 days of CNV1014802~     150mg three times a day (tid). Responders will be randomized to 28 days of CNV1014802 150mg~     tid or placebo.~      Following an interim analysis after 10 evaluable patients have completed the open-label~     phase, the dose regimen may be increased to 350mg twice a day (bid) for the remainder of the~     trial if the responder rate is less than 60%.~   "
154758|NCT01540617|"~     Low back pain (LBP) is a well known health problem in Western society that is significantly~     responsible for socio-economic problems like absenteeism and disability. The lifetime~     prevalence of LBP is 60-80% and approximately 85% of this LBP has a non-specific character~     whereby the underlying causes and risk factors cannot be demonstrated. While many people~     recover within a month, most individuals will have recurrence within a year with more severe~     symptoms. This might be due to insufficient knowledge of the underlying mechanisms. Impaired~     proprioception, the ability to discern body/limb positions and movements, may cause and~     maintain LBP shown by an altered postural control strategy. Specifically, patients with LBP~     rely more on proprioceptive signals from the ankles due to less reliable proprioceptive input~     of proximal segments. Moreover, they show a decreased variability in postural control and~     less postural robustness, while variability is a prerequisite for optimal functioning of~     biological systems. However, further clarification of the neural correlates is necessary.~     Deficits in proprioception, as found in a subgroup of patient with LBP, are associated with a~     decreased ability of the brain to process proprioceptive inputs.~      The aim of this project is to clarify the central changes in individuals with recurrent~     non-specific low back pain and healthy controls. To evaluate these central changes MRI~     techniques (3DTFE, DTI and RS-fMRI) will be used. In addition, the association between~     central changes and postural control tasks will be evaluated.~   "
154759|NCT01540604|"~     This is an investigation of the efficacy and safety of CRD007 in Duchenne Muscular Dystrophy~     (DMD), Becker Muscular Dystrophy (BMD) and symptomatic carriers.~   "
154760|NCT01540591|"~     Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm~     injection ( ICSI) failure due to elevated TH1 cytokine response.~   "
154761|NCT01540578|"~     This clinical trial is studying biomarkers as a diagnostic tool in samples from younger~     patients with B-cell acute lymphoblastic leukemia. Finding specific biomarkers may help~     improve the treatment of patients with B-cell acute lymphoblastic leukemia~   "
154762|NCT01540565|"~     This phase II trial studies how well veliparib works in treating patients with epithelial~     ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond~     to treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
154763|NCT01540552|"~     RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung~     cancer may help doctors learn more about the disease and find better methods of treatment.~      PURPOSE: This trial studies the natural history of lung nodules using CT scans from~     participants at high-risk for lung cancer.~   "
154764|NCT01540539|"~     The purpose of this study is to study the safety and tolerability of intravenous (IV) and~     subcutaneous (SC) administration of REGN1154 in normal healthy subjects.~   "
154765|NCT01540526|"~     The main purpose of this study is to learn more about the safety of an investigational drug,~     axitinib. An investigational drug is a drug that has not been approved by the Food and Drug~     Administration (FDA) and is available for research use only. Researchers will also see what~     changes happen to the tumors while taking the axitinib and after it is stopped (during the~     scheduled breaks), and what changes in the tumor may be responsible for this growth. This~     will be done by using a special kind of scan called an 18F-FLT PET/CT. This scan is~     considered an investigational type of scan and is not used for clinical care. These scans are~     not approved by the FDA, their use in this study is just for research purposes.~      In addition, the investigators want to find out how the drug is processed and distributed in~     the human body. The investigators will also look at how different types of cancer are~     affected by axitinib.~   "
154766|NCT01540513|"~     The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404~     PET/CT in human brain tumors. This goal will be accomplished by quantifying tumor uptake and~     determining the optimal PET/CT protocol, comparing PET tumor uptake to MRI, and calculating~     tumor dosimetry. The long-term goals of this research are to improve the diagnosis and~     treatment of malignant brain tumors by using radioiodinated NM404~   "
154767|NCT01540500|"~     The purpose of this research study is to evaluate whether administration of a CYP1A2~     inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The~     safety and tolerability of tasimelteon will also be assessed throughout the study.~   "
154768|NCT01540487|"~     The aim of the trial is to assess the relative bioavailability of fixed dose combination~     tablets of linagliptin and metformin compared to the administration of two single tablets~     (linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose~     combination tablet is expected to significantly enhance patients` compliance with~     antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic~     patients.~   "
154784|NCT01540279|"~     Background: Poor wound healing and the development of surgical site infection (SSI) continue~     to occur and remain a significant cause of disability among operated patients. In spite of~     the substantial advances in our understanding of the epidemiology, pathogenesis and~     prevention it remains one of the most common complications in conventional abdominal surgery~     with an incidence in the literature between 4% and 17%. As it is known that surgical sutures~     potentiate the development of wound infection the search for an ideal suture material,~     suitable for all purposes has been pursued by surgeons for decades.~      Hypothesis: In line with in-vitro results the investigators hypothesize that the use of~     antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after~     open abdominal surgery Methods: To prevent microbial colonization of suture material in~     operative wounds and therefore to prevent SSI, triclosan-coated poliglecaprone 25 suture~     materials with antibacterial activity will be tested against un-coated suture material for~     skin closure after open abdominal surgery of 200 patients. The study is planed as a single~     center, randomized controlled trial. After ethical approval the patients will be~     consecutively enrolled from 2011 to 2012 in the Department of Visceral Surgery, University~     Hospital Basel, Switzerland. The patients will be followed for 30 days (day 3,7 and 30) to~     detect and document wound complications. Wound complications will be classified according to~     Center for Disease Control and Prevention Standard guidelines. Data will be collected and the~     rate of SSI will be analysed in both groups.~      Expected value of the proposed project: If the investigators can confirm the proposed~     hypothesis in our study this could be a promising and feasible approach to lower SSI after~     open abdominal surgery and might be also used in other surgical fields. By lowering the rate~     of SSI the investigators might offer a new and cost saving procedure to the surgical~     community.~   "
154769|NCT01540474|"~     Malaria has remained a major concern for the US military. During World War II, malaria was~     the leading cause of disease and non-battle injury with 500-700 men infected per day,~     resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for~     protecting troops against malaria are insecticidal nets, clothing, and antimalarial~     treatment. To be effective, these methods must be self-administered and be used consistently,~     often unattainable in field or combat situations. The United States Army Medical Research and~     Development Command (USAMRMC), through the United States Army Medical Materiel Development~     Activity (USAMMDA) and the Walter Reed Army Institute of Research (WRAIR) are actively~     pursuing the development of an effective vaccine against P. falciparum malaria; development~     of such a vaccine is a high priority for the US military and other individuals who travel to~     endemic regions, and is equally important to populations residing in those areas.~      A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS) vaccine~     will~        1. assess the safety and reactogenicity of candidate P. falciparum malaria vaccine~          FMP012/GLA-SE~           Secondary:~        2. measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent~          assay (ELISA)~        3. assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite~          challenge.~   "
154770|NCT01540461|"~     The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability~     of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).~   "
154771|NCT01540448|"~     The aim of this study is to evaluate if the prior knowledge of the individual mesenteric~     vascular anatomy of patients represents an advantage in performing laparoscopic colorectal~     resections. The investigators want demonstrate that the three-dimensional reconstruction of~     colonic vascular anatomy, acquired with a CT angiography, may lead to a more effective and~     less extensive dissection and to a fewer intraoperative and postoperative complications.~   "
154772|NCT01540435|"~     This randomized, controlled, multicenter, non-comparative phase II trial compares an~     intensified perioperative treatment of patients with resectable synchronous or metachronous~     colorectal liver metastases to primary surgery and adjuvant systemic chemotherapy.~   "
154773|NCT01540422|"~     The purpose of this study is to demonstrate improved vein graft patency rates at 12 months~     for endoscopically harvested saphenous vein grafts. The study will evaluate use modifications~     to existing techniques in vein graft handling during harvests. A secondary aim is to develop~     a standardized approach for harvesting, handling, and preparing vein grafts in the endoscopic~     approach.~   "
154774|NCT01540409|"~     The primary objective of this study is to assess the ongoing efficacy, safety, and~     tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne~     muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen~     study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers~     for DMD and the clinical status of participating DMD subjects.~   "
154775|NCT01540396|"~     This is a pilot feasibility study of 40 pregnant women to test the investigators'~     recruitment, enrollment and randomization procedures in preparation to conduct a larger~     randomized control trial to compare diagnostic methods for gestational diabetes. The two~     methods that are being compared are the 2 hour 75 gram OGGT (2011 ADA guidelines) versus a 1~     hour 50 gram GCT + 3 hour 100 gram OGTT if the 1 hour result is abnormal (Carpenter and~     Coustan criteria).~   "
154776|NCT01540383|"~     The purpose of this study is to examine whether 3 weeks of intensive language therapy~     provided in clinical in- and outpatient settings is effective in improving everyday~     communication in postacute/chronic post-stroke aphasia, as measured by performance on the~     Amsterdam Nijmegen Everyday Language Test (ANELT).~   "
154777|NCT01540370|"~     This study will evaluate assessments from the Goniometric Lens compared with those from~     anterior segment imaging in patients with open-angle glaucoma (OAG) and/or ocular~     hypertension (OHT).~   "
154778|NCT01540357|"~     In the present randomized waiting-list-controlled study the investigators examined a specific~     manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.~   "
154779|NCT01540344|"~     The COMBATAC study evaluates the the effect as assessed by progression-free survival (PFS) of~     perioperative systemic chemotherapy including cetuximab and cytoreductive surgery (CRS) and~     bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal~     carcinomatosis arising from colorectal cancer.~   "
154780|NCT01540331|"~     The purpose of this study is to evaluate prospectively the PNT safety and efficacy in term of~     IOP reduction in a group of previously or newly diagnosed glaucomatous subjects.~   "
154781|NCT01540318|"~     The major goal of this project is to conduct a randomized controlled trial studying an~     initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal~     ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's~     objectives are to compare the following variables in those that randomize to abdominal~     ultrasound versus those that do not:~        1. rate of abdominal CT scanning~        2. time to emergency department disposition~        3. the rate of missed/delayed diagnosis of intra-abdominal injury~        4. the costs.~   "
154782|NCT01540305|"~     This study aimed at verifying whether sessions of repetitive transcranial magnetic~     stimulation over a certain brain area (the supplementary motor area) could be useful in the~     relief of Obsessive-Compulsive Disorder symptoms.~   "
154783|NCT01540292|"~     This project aims to assess safety and efficacy of allogeneic Mesenchymal stem Cell (MSC) in~     Crohn's disease refractory or intolerant to conventional therapies. Twenty patients with~     active refractory Crohn's disease defined by a Crohn's Disease Activity Index (CDAI) > 220~     despite conventional treatment will be included over 4 years in this phase I-II trial. This~     will be a pilot open label trial. Patients will be treated with 2 successive injections of~     allogeneic MSC at baseline and 4 weeks later. Patients will be followed up at weeks 2, 4, 8~     and 12.~   "
154785|NCT01540266|"~     Assessing whether structuring of discharge information improves the sender's recall capacity~   "
154827|NCT01539707|"~     The purpose of this study is to evaluate blood levels of solifenacin succinate (the study~     drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If~     the bladder contracts strongly and without warning, the muscles surrounding the urethra~     (detrusor muscles) may not be able to keep urine from passing. This may happen as a~     consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.~   "
154786|NCT01540253|"~     This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when given~     together with docetaxel in treating patients with advanced solid tumor that is locally~     advanced, cannot be removed by surgery, or metastatic. PI3K inhibitor BKM120 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120~     together with docetaxel may kill more tumor cells.~   "
154787|NCT01540240|"~     The primary objective of the study is to compare the tolerance and safety between a low-dose~     Zidovudine (AZT) containing regimen (200 mg BID) and a standard dosage (300 mg BID) in HIV~     patients initiating a first line antiretroviral therapy. The investigators expect that the~     low-dose regimen will show improved tolerability and safety compared to the standard dosage,~     with significant reduction in number of patients experiencing a new grade 1 to 4 anaemia or~     increasing their anaemia grade during the first 6 months of treatment.~      The secondary objectives of the study is to compare the efficacy of the two dosing regimen,~     as measured by classical clinical and biological markers: the number of new AIDS defining~     illness, the mortality rate, the proportion of patients achieving virological success and the~     mean CD4 cell count increase from baseline.~   "
154788|NCT01540227|"~     Syphilis is a sexually transmitted infection that causes genital sores and rash, but in some~     circumstances may result in more severe and unexpected symptoms. These severe symptoms could~     include eye infections, meningitis (infection of the membranes covering the brain and spinal~     cord), and liver infection. If not properly treated, syphilis can also lead to heart problems~     and dementia (a decline in reasoning, memory and other mental abilities) years down the road.~     There has been an increase in the number of reported cases of syphilis in North America,~     Europe, and Australia over the past decade. The number of new syphilis infections in Canada~     has increased roughly 10-fold over the past 10 years.~      Since 1943, the antibiotic penicillin has been used to treat syphilis; however, very little~     information has been gathered to determine the proper dose of penicillin or appropriate~     duration of treatment. Added to this, several studies have shown that the recommended dose of~     penicillin fails to cure syphilis in 20-30% of patients. Since the number of people infected~     with syphilis is increasing, and since syphilis has the potential to cause serious disease,~     the investigators need better information on how to treat syphilis effectively.~      This study aims to determine whether the current dose of penicillin recommended to treat~     syphilis is sufficient to cure the infection. Specifically the investigators will try to~     determine whether the amount of penicillin in your blood 3 and 7 days after receiving~     treatment for syphilis is sufficient to cure the infection as demonstrated by a blood test 6~     or 12 months from now. This study is a multi-centered trial based in Ottawa but with centers~     recruiting both in Montreal and Toronto. A total of 120 participants with syphilis will be~     recruited into this study. The treatment you will receive for syphilis in this study does not~     differ from that you would receive normally; the investigators are only observing the levels~     of penicillin in your blood and relating them with the outcome of treatment.~   "
154789|NCT01540214|"~     Pelvic organ prolapse (POP) is a common problem. Symptoms of overactive bladder (OAB) are~     present in approximately 50% of patients with POP. For many women the accompanying symptoms~     of OAB are an important reason for seeking help for their POP. Surgical repair of prolapse~     may improve OAB complaints. Persisting or de novo OAB symptoms are strongly correlated with~     dissatisfaction with the final results of an operation for POP.~      The primary aim of this research project is to investigate the difference in prevalence (i.e.~     improvement) of OAB and bothersome OAB symptoms at 6 and 12 months after POP repair surgery.~     The secondary objectives are to determine changes in bladder function at 6 and 12 months~     after surgery and to identify predictive factors for persistence, disappearance or de novo~     symptoms of OAB after POP surgery.~      Women who present with POP and who will undergo surgical treatment will be evaluated at~     baseline before their surgery and will be followed for the duration of one year after~     surgery.~   "
154790|NCT01540201|"~     Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation~     (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the~     inspiratory time greater than expiratory time, can be applied for adult respiratory distress~     syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway~     pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV with~     lung protective strategy.~   "
154791|NCT01540188|"~     Vietnam is currently experiencing two epidemics -- injection drug use and HIV. HIV infection~     is rising rapidly, primarily among injecting drug users (IDUs). Most young IDUs keep daily~     contact with their family or live in their parent's home. The burden on their families is~     substantial, and even greater if the IDU is HIV+. In this study, the investigators conduct an~     intervention pilot to develop and evaluate a family intervention to improve outcomes over~     time for Vietnamese IDUs and their families. This two-year study is conducted in Phu Tho, a~     province located about 80 km from Hanoi, Vietnam's capital.~      Two teams with complementary expertise collaborate to implement this study: the UCLA team and~     the Vietnamese team from the Vietnam National Institute of Hygiene & Epidemiology (NIHE). The~     study has two phases:~        -  In Phase 1, the investigators develop the content, format and an implementation plan for~          the intervention from a focus group of 10 service providers, administrators and~          community leaders, and through in-depth interviews with 40 IDUs (20 HIV+ and 20 HIV-)~          recruited from the local drug rehabilitation center (the 06 Center) and from two local~          communities (Duu Lau and Gia Cam), as well as in-depth interviews with 20 of the IDUs~          family members (FM). Based on the findings, the investigators collaborate on designing a~          Vietnamese-specific family intervention for IDUs and their family members.~        -  In Phase 2, the investigators pilot the intervention in the local commune health centers~          in Viet Tri, Phu Tho. Eighty IDUs (HIV+/HIV-) and 80 of their family members are~          recruited from 4 communes and the 06 Center in Viet Tri city, and randomized into a~          intervention group and a control group. After the 4-week intervention, 3-month and~          6-month follow-ups are conducted to assess the effectiveness of the intervention.~          Participants randomized to the control group only complete the assessments (baseline,~          3-, and 6-month) at the same time points.~   "
154792|NCT01540175|"~     Autologous stem cell rescue is an established therapy in high risk neuroblastoma and relapsed~     Hodgkin's lymphoma and an experimental therapy in some other solid and brain tumors to~     facilitate the use of very intense chemotherapy beyond bone marrow tolerance. It is usually~     tolerated with acceptable toxicity and graft failure is practically not existent. But whereas~     immune reconstitution in allogeneic hematopoietic stem cell transplantation (HSCT) setting is~     widely studied, the investigators have no comprehensive data available in the autologous~     setting regarding recovery of the innate and adaptive immune system. However, observations in~     patients with autoimmune disease undergoing autologous HSCT suggest not an exact recovery of~     the patient's pre-transplant immune system but some re-education during reconstitution of~     immune function.~      Also, recent developments of cancer-directed immunotherapy with monoclonal antibodies and~     immunocytokines rely on activity of the patient's own immune system via complement-mediated~     or antibody-dependent cellular cytotoxicity. These novel therapies are given either with or~     shortly after conventional chemotherapy. To find the optimal time point for administration of~     immunotherapy, it is important to know how and when immune effector cells recover after~     conventional myelosuppressive and/or immunosuppressive chemotherapy which are used in~     Induction regimens.~      Researchers at St. Jude Children's Research Hospital want to study the research participant's~     immune profile once prior and at multiple set time points after autologous stem cell infusion~     during the recovery process. In a subset of participants the investigators want to study the~     recovery of lymphocyte subsets and function after one course of conventional chemotherapy~     preceding the high dose chemotherapy and autologous stem cell transplant. That way the~     investigators hope to learn about the pace and order of recovery and the functional capacity~     of different compartments of the immune system during reconstitution.~   "
154828|NCT01539681|"~     Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular~     Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with~     sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate~     the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC~     under daily-life treatment conditions.~   "
154796|NCT01540123|"~     Berry fruits are widely recognised as natural functional food products. They contain several~     different phytochemicals which have potential to modulate human health and wellbeing. There~     is however some debate regarding the mechanisms driving their health promoting properties.~      Despite the wide health promoting properties of fruit extracts reported in the literature,~     considerable interest over the past decade has primarily been focused on their roles in~     reducing risk factors associated with cancer and heart disease. Consequently, there remains a~     paucity of actual scientific information on their role in modulating brain functions, such as~     mood, learning and memory, any decrements of which have very negative impacts on the quality~     of life.~      Fruit phytochemicals from other sources have been shown to mediate both peripheral and~     cerebral blood flow. However, a modulation of cerebral blood flow has not been shown with~     berries as yet. Cerebral blood flow must be maintained to ensure a constant delivery of~     oxygen and glucose as well as the removal of waste products. The modulation of cerebral blood~     flow via supplementation of berry polyphenols could therefore be a potential way to~     positively modulate human cognitive behavior. The link between acute increases in cerebral~     blood flow and increased cognition is currently a little weak but it could give a good~     platform for long term behavioral and health benefits via increased cerebral/peripheral blood~     flow and decreased MAO-B activity.~      The aims of the study are therefore to investigate the impact of the berry extract on digital~     volume pulse, blood pressure and cerebral blood flow.~   "
154797|NCT01540110|"~     Primary~      The purpose of this study is to evaluate tumour pathological complete response rate after six~     cycles of neoadjuvant docetaxel and cyclophosphamide in an Asian population.~      Secondary~      To assess:~        1. Pharmacokinetics (PK) and pharmacogenomics (PG) of docetaxel cyclophosphamide in Asian~          patients,~        2. Safety and toxicity of docetaxel cyclophosphamide in Asian patients, and~        3. To determine efficacy of short course (3 days) filgrastim in primary and secondary~          prophylaxis against febrile neutropenia in patients receiving docetaxel and~          cyclophosphamide.~   "
154798|NCT01540084|"~     Endoscopic retrograde cholangiopancreatography (ERCP) practically requires moderate to deep~     sedation by a combination of benzodiazepine and opioid. Propofol as a sole agent may cause~     oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can~     reduce the dosage of propofol and may result in a lower risk of oversedation. The~     investigators prospectively compare the efficacy, recovery time, patient satisfactory, and~     side effects between cocktail and conventional sedations in patients undergoing ERCP.~   "
154799|NCT01540071|"~     This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing~     down/stopping/reversing progression of the castration resistant and taxane resistant prostate~     cancer.~   "
154800|NCT01540058|"~     This is a european randomised, phase III, multi-centric study comparing a diagnostic and~     therapeutic strategy based on molecular analysis followed by suspected primary cancer~     tailored specific therapy, to an empiric strategy in patients with carcinoma of unknown~     primary. The purpose of this trial is to determine whether or not a strategy based on~     molecular analysis is effective in improving the progression free survival rates of patients~     with carcinoma of unknown primary (CUP).~   "
154801|NCT01540045|"~     One of the most widely used treatments for non-small cell lung cancer (NSCLC) is the~     combination of paclitaxel-cisplatin. These drugs may contribute to taste alterations like~     dysgeusia. Which alters the feeding of cancer patients, contributing to the anorexia, weight~     loss and malnutrition, which leads to a prognostic impact in a lower patient response to~     chemotherapy, radiotherapy and surgical treatment as well as increased toxic effects,~     impacting treatment discontinuation and therefore, morbidity and survival of patients. The~     objective of this study is to describe the threshold of perception and recognition of basic~     tastes in patients with NSCLC before treatment with platin and paclitaxel-based chemotherapy~     and after the second cycle, and analyze the effect in the developement of dysgeusia, as well~     as the association between these and the nutritional status and quality of life.~   "
154802|NCT01540032|"~     The purpose of this study is to determine whether a low salicylate diet will improve the~     quality of life of patients with Aspirin Exacerbated Respiratory Disease (AERD).~   "
154803|NCT01540019|"~     Denutrition, lost of weight and anorexia are present in many oncologic patients at any time~     of the disease. Anorexia is the spontaneous loss of appetite and many changes in the~     metabolism are made in this case, leading to this syndrome called anorexia-cachexia, that~     includes changes in the tumoral response and inflammatory pathways. The guaraná (Paullinia~     cupana) is originally from Brazil and Venezuela and has been used culturally for headaches,~     muscle pains, depression and others. As it has shown a good response and tolerability for~     fatigue, the investigators decide to try guaraná for anorexia. Patients will receive guaraná~     as capsules of 50 mg twice daily, for 4 weeks, and will be weighted and respond questionaries~     about quality of life.~   "
154804|NCT01540006|"~     The aim of this prospective trial is the manifestation of guidelines developed for outpatient~     cardiac rehabilitation in Austria.~      The evaluation of prospective and retrospective data is supposed to give evidence on~     morbidity and/or mortality advantages compared to patients not participating in cardiac~     rehabilitation programs.~      The database created in this context is supposed to pave the way as instrument to document~     and comprehend quality and cost effectiveness of outpatient cardiac rehabilitation in Austria~     as a key for quality management.~   "
154805|NCT01539993|"~     This study is designed for patients diagnosed with Liver cancer to collect information about~     the relationship between types of liver cancer, methods of treatment and outcomes over time.~   "
154806|NCT01539980|"~     1. Silk sericin wound dressing may reduce time for complete epithelialisation of~          split-thickness skin graft donor sites compared to Bactigras®.~        2. Silk sericin wound dressing may reduce pain level at split-thickness skin graft donor~          sites compared to Bactigras® .~        3. Silk sericin wound dressing may not cause split-thickness skin graft donor sites~          infection as compared to Bactigras®.~        4. Split-thickness skin graft donor sites which treat by silk sericin wound dressing may~          not cause significant adverse events.~   "
154829|NCT01539668|"~     This study evaluates the women cervical samples through molecular tests in order to:~      1. Deploy the test careHPV (hybrid capture test) in mobile unities of the Barretos Cancer~     Hospital to evaluate their performance;~   "
154830|NCT01539655|"~     Study in healthy volunteers to assess effect of omeprazole and ranitidine on the~     pharmacokinetics of vandetanib~   "
154808|NCT01539954|"~     The goal of this project is to develop a computerized screening program for primary care~     offices that is based on the NIAAA's Alcohol Screening Guide for Children and Adolescents and~     assess its psychometric properties among nine- to 18-yr-old primary care patients. There have~     been few studies of alcohol screening and brief intervention conducted among adolescents~     receiving primary medical care. This project will develop and validate a new computerized~     Alcohol Screening for Children and Adolescents (cASCA) system based on the two age-specific~     screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk~     and problem assessments. The system will yield a provider report with the screening results,~     level of risk, and recommended brief advice, counseling, or referral strategies. The Specific~     Aims of this project are to: 1)Assess the sensitivity, specificity, positive and negative~     predictive values of the 'any drinking/number of drinking days' and 'friends' questions of~     the cASCA in identifying past-year use as determined by the Timeline Follow-Back Calendar~     (TLFB), and for identifying any problem use, abuse or dependence as determined by the AUDIT,~     CRAFFT and a structured psychiatric diagnostic interview (computerized DISC-IV, Youth~     Version) at baseline (criterion validity); 2)Assess the test-retest reliability of the cASCA~     in measuring drinking frequency categories and in classifying patients into Low, Medium and~     High risk categories; 3)Assess the predictive validity of the 'any drinking/number of~     drinking days' and 'friends' questions in predicting drinking, binge drinking, and any~     problem use, abuse or dependence at 12-mos follow-up; 4)Assess the degree to which the 'any~     drinking/number of drinking days' item of the cASCA predicts drug use risk as measured by the~     TLFB (any use and frequency), tobacco use as measured by the Hooked on Nicotine Checklist~     (screen for potential nicotine dependence), drug use disorders as measured by the Drug Abuse~     Screening Test for Adolescents, and the degree to which it predicts other mental health~     problems as measured by the Youth DISC Predictive Scales at baseline and 12-month follow-up;~     5)Compare the psychometric properties of the cASCA across subgroups, including: age, gender,~     race/ethnicity, practice type, provider type, and patient risks (e.g., those with/without~     friends who drink); and explore the possible effects of the cASCA system on drinking at 3-,~     6-, 9-, and 12-month follow-ups.~   "
154809|NCT01539941|"~     The goal of this proposal is to develop and pilot a brief protocol designed to systematically~     integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD)~     into behavioral treatment services for adolescent substance users with comorbid ADHD in~     everyday care. ADHD is a prevalent co-occurring condition for adolescent substance use (ASU)~     that can significantly impede successful ASU treatment but is vastly under-diagnosed and~     undertreated among ASU clients in agency settings. Moreover, ADHD medication acceptance and~     compliance is particularly difficult to achieve in high-risk adolescent populations.~   "
154810|NCT01539928|"~     The purpose of this study is to compare conventional PET/CT scan performed 1 hour after~     injection of the radioactive tracer FDG (PET/CT[1]) with PET/CT performed after 3 hours~     (PET/CT[3]) in a group of patients with biopsy verified lung cancer or high suspicion of lung~     cancer after initial work-up (chest x-ray and CT of thorax/upper abdomen), who are~     potentially operable.~   "
154811|NCT01539915|"~     This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic~     patients to better understand the skin penetration of topically applied BCT194.~   "
154812|NCT01539902|"~     The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on~     remission of lupus nephritis (combined partial and complete remission) in terms of~     stabilization and improvement in renal function.~   "
154813|NCT01539889|"~     Pulmonary hypertension (PH) can be the result of various clinical conditions. It may be~     idiopathic or associated with various cardiovascular and lung disorders. Currently there is~     no test that can non-invasively detect abnormalities of the pulmonary circulation. There is a~     growing need for a non-invasive method to detect PH. There currently exists only ne agent~     approved in Canada for clinical imaging of the pulmonary circulation, 99mTc-labeled~     macroaggregates. This agent is exclusively used for the diagnosis of physical defects of the~     circulation due to pulmonary embolus. This agent is larger than small pulmonary vessels,~     limiting its sensitivity to detect small vascular defects, as well as potential infectious~     risks since albumin macroaggregates are derived from human albumin. There is need then for~     new lung tracers that could provide a greater safety profile while enabling functional as~     well as anatomical imaging of the pulmonary circulation. DFH-12 (PulmoBind) is a peptide~     derived from human adrenomedullin (hAMI-52). Hence the development of this novel AM~     derivative, PulmoBind, for molecular imaging of the pulmonary circulation. PulmoBind is~     labeled with 99mTc, the most commonly used imaging isotope in nuclear medicine.~   "
154814|NCT01539876|"~     The purpose of this study is to assess the fine needle aspiration methodology in collecting~     sufficient tumour cells to measure tissue TNFa levels serially in human breast cancer sample~     receiving Taxane treatment~   "
154815|NCT01539863|"~     As low back pain is often a recurrent and sometime persistent problem, research into~     prevention is important. Chiropractors have traditionally treated patients with maintenance~     care, which means that patients are seen on a regular basis to prevent recurrences or to stop~     a persistent problem getting worse. However, it is not known if this has the expected effect.~      This study will test the effectiveness of the maintenance care approach. Patients with~     recurrent or persistent low back pain will be treated in accordance with two different~     models. The first model is the maintenance care model, meaning that chiropractors will see~     the patient on a regular basis, regardless symptoms. The other model means that patients~     should be treated patients only when they themselves experience symptoms bad enough to seek~     care. After one year, it will be possible to see if there has been any difference between the~     groups in terms of pain, disability, quality of life and total number of treatments over the~     study period and to investigate if there is any difference in the cost-effectiveness between~     the two treatment models.Thus, the study hypothesis is that there is no difference between~     the two models regarding the number of days with pain.~      This study will be a multi-centre trial, and as part of the study, it will be necessary to~     formalize a network of research clinics all over Sweden in which participating chiropractors~     accept to perform complex data collection. This network will then have the expertise and~     potential to perform future clinical studies together with networks in other countries,~     allowing large clinical trials across countries.~   "
154816|NCT01539850|"~     The main objective of this study is to evaluate the LGL102 implant safety in obese to~     morbidly obese subjects treated with OMS102 system. The effect of the therapy on body weight~     changes will be also evaluated.~   "
154831|NCT01539642|"~     The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA~     System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute~     moderate to severe post-operative pain after open abdominal surgery.~   "
154832|NCT01539629|"~     This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D~     device to evaluate a new feature for future heart failure devices.~   "
154833|NCT01539616|"~     ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected to~     decrease triglyceride level and also correct dyslipidemia.~   "
154834|NCT01539603|"~     The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon~     first and then bare metal stent compared with drug-eluting stent for treatment of de novo~     lesions (DEB first).~   "
154817|NCT01539837|"~     Parkinson's disease (PD) is a common neurodegenerative disease affecting movement. Although~     drug treatments for PD are available they only treat the symptoms of the disease, fail to~     halt neuronal loss, and are associated with long term side effects and loss of efficacy.~     There is a chronic need to develop neuroprotective therapies. Increased iron and oxidative~     stress have been heavily implicated in the neurodegenerative process in PD, hence removal of~     excess iron by iron chelation represents a potential drug target. Iron chelators are~     extensively utilised to treat peripheral iron overload disorders (e.g. thalassaemia) and~     recently the investigators have demonstrated iron chelators such as Deferiprone can enter the~     brain removing excess iron and are neuroprotective in PD animal models. Although good~     tolerability and efficacy to remove brain iron has also been shown in a pilot study with the~     iron chelators Deferiprone in young patients with Friedreich Ataxia, where iron accumulates~     in the dentate nucleus, no studies have been conducted in aged individuals affected by PD.~     Hence the aims of this study are 1) to assess whether Deferiprone is well tolerated in PD~     patients, 2) whether Deferiprone can remove the excess iron levels found in the brain area~     affected by PD, the substantia nigra, as assessed by Magnetic resonance imaging (MRI) and 3)~     whether Deferiprone has any direct effect on the clinical symptoms of PD. Three groups of 12~     (total 36) early stage drug free PD patients will be treated with 20 or 30mg/kg/d Deferiprone~     or Placebo for 6 months. Over the 6 months patients will receive serial MRI scans,~     neurological examinations not only to assess PD symptoms but also psychological state, plus~     blood test to monitor for potential side effects. Positive results from this pilot will help~     support larger clinical trials to evaluate whether Deferiprone can slow down/halt PD.~   "
154818|NCT01539824|"~     The purpose of this study is to investigate the safety and effects of IMM 101 in combination~     with a single targeted dose of radiation in patients with metastatic colorectal cancer in~     whom chemotherapy or other treatment has not been effective. Administration of radiation~     (using the CyberKnife) to the target tumour growth in the liver results in the release of~     tumour material. IMM-101 may help the immune system to react to the tumour material released~     from the damaged tumour, and so have a beneficial effect in slowing down the rate of growth~     of other tumour growths in the liver and other organs.~   "
154819|NCT01539811|"~     This is a pilot study to explore the effects of long-course versus short course antibiotics~     on wound healing in surgically managed diabetic foot infections. Hypothesis: Diabetic Foot~     Infections (DFIs) are best managed with an early aggressive surgical approach and short term~     antibiotic use. Post-operative prolonged antibiotic use increases costs and resource~     utilization without improving outcomes.~   "
154820|NCT01539798|"~     The investigators conducted a cross-over study to compare the response of healthy young~     volunteers to a rapid oral intake or intravenous infusion of 0.9% saline solution on the body~     composition, serum electrolytes, albumin, and hematological parameters.~      The investigators hypothesized that these parameters will differently adapt depending on the~     route of infusion~   "
154821|NCT01539785|"~     The purpose of this study is to determine the role of surgery followed by hyperthermic~     intra-peritoneal chemotherapy (HIPEC) versus surgery alone in patients with~     platinum-sensitive first recurrence of ovarian cancer. Moreover it is a prospective~     randomized multicenter trial, aimed to investigate the prognostic role of surgery plus HIPEC~     versus surgery alone in terms of progression free interval, overall survival, morbidity and~     mortality, second recurrence pattern, quality of life with EORTC QLQ-C30 and QLQ OV28~     questionnaires.~   "
154822|NCT01539772|"~     This is a multi-center natural history study that will be conducted at participating centers~     in the Cooperative International Neuromuscular Research Group (CINRG). Following a baseline~     evaluation, participants will have three follow-up visits over a three-year period. The~     investigators will characterize the Becker muscular dystrophy phenotype, and correlate~     specific abnormal dystrophin proteins with the range of clinical outcomes.~   "
154823|NCT01539759|"~     This is a randomized controlled trial among women who deliver by cesarean at UNC Women's~     Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After~     consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a~     postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the~     Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8~     week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that~     women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months~     later than women who plan on receiving an IUD 4-8 weeks after delivery.~   "
154824|NCT01539746|"~     The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for~     predilation of the native aortic valve is associated with a reduction of the composite~     primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction~     (LVEF ≤35%).~   "
154825|NCT01539733|"~     The investigators designed a randomised multicenter clinical trial for patients with advanced~     cancer who are admitted to the medical oncology ward or high-care hospice. On admission all~     patients with advanced cancer will be asked to participate in this study. Consenting patients~     will be submitted to delirium observation screening according to the DOS. Subsequently DOS~     screening will be performed twice weekly until discharge. Each patient who's score is > 3~     (DOS positive) is showing significant symptoms of delirium and will be submitted to the~     revised Delirium Rating Scale (DRS-R-98) to confirm diagnosis. To test validity of the DOS~     scale for this particular population, each DOS positive score will be randomly matched with a~     patient with a DOS score < 3 (DOSnegative) and this patient will also be submitted to~     DRS-R-98. When diagnosis of delirium is confirmed by DRS-98, patients will be randomised~     between treatment of delirium with olanzapine or haloperidol (usual care). Treatment in both~     groups will consist of identification and management of underlying aetiologies of delirium if~     possible and adding neuroleptic medication for symptom control. Patients who recover from~     their delirium episode as well as their caregivers will be asked to complete the Delirium~     Experience Questionnaire (DEQ) to assess recall of the delirium experience and the degree of~     distress related to the delirium episode.~   "
154826|NCT01539720|"~     The purpose of this research study is to test the levonorgestrel intrauterine system as a~     method for emergency contraception. Emergency contraception refers to pregnancy prevention~     after an act of intercourse.~      While the levonorgestrel intrauterine system is approved as a contraceptive method, it is~     considered investigational as emergency contraception, which means that it has not been~     approved by the U.S. Food and Drug Administration. This study will compare the device to the~     most common types of emergency contraception, oral Ulipristal acetate, or oral~     levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency~     contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a~     1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved~     as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This~     method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.~   "
154836|NCT01539577|"~     This study is a multicenter, prospective, observational study to evaluate the long-term~     safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion~     (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior~     segment uveitis in real-world clinical practice.~   "
154837|NCT01539564|"~     The objective of the study is to evaluate the safety and effectiveness of Arestin~     (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when~     used in combination with mechanical debridement.~      The hypothesis of the study is that Arestin in combination with mechanical debridement is~     more effective in the treatment of peri-implantitis when compared to mechanical debridement~     alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as~     measured at qualifying implant sites.~   "
154838|NCT01539551|"~     B-type natriuretic peptide (BNP) is a cardiac neurohormone which rapidly released by the~     ventricle in response to myocardial stretch. BNP has been used as a biomarker of sepsis~     related cardiac dysfunction and volume overload in critical ill patients. It is also a marker~     associated with prognosis in patients with severe sepsis and septic shock. However, the~     clinical utility of BNP level in management of early severe sepsis and septic shock over the~     first 48 hours is not clear. Besides, Lactate represents as a maker of tissue hypoperfusion,~     which has been used as a guide therapy for sepsis patients and high serum lactate level is~     independently associated with mortality in severe sepsis. Today, in management of early~     severe sepsis and septic shock, current guideline emphasize the early goal-directed therapy~     (EGDT) with achieving the central venous pressure (CVP) level 8-12 mmHg by fluid support~     first, then targeting the next goal to maintain mean airway pressure (MAP) at least 65 mmHg~     by vasopressor agent (ie, Norepinephrine) and finally keeping central venous oxyhemoglobin~     saturation (ScvO2) > 70% via optimal Hct > 30% and dobutamine usage within first 6 hours of~     emergency department admission. However, the role of BNP and lactate in patients with severe~     sepsis and septic shock with or without myocardial dysfunction under EGDT management are not~     clear.~      The investigators will conduct a prospective observational study to investigate the change of~     BNP and Lactate within 48 hours in early severe sepsis and septic shock under EGDT~     management, their association of cardiac dysfunction and their role in predicting various~     clinical outcome. The investigators also want to see if BNP and lactate could be useful tools~     to guide the adjustment of optimal fluid supply and the timing of inotropic agent~     intervention.~   "
154839|NCT01539538|"~     The study is intended to show that the Sufentanil NanoTab PCA System is as effective as~     morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery.~     Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat~     their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.~   "
154840|NCT01539525|"~     The investigators propose to use obstetric-gynecological clinics to conduct a randomized~     clinical trial that would compare two SBIRTS (Screening, Brief Intervention, Referral and~     Treatment), delivered either by a trained nurse or by computer, to usual care (a control~     condition). As part of this trial, the investigators will include outcomes that allow us to~     assess the cost effectiveness of these three conditions.~   "
154841|NCT01539512|"~     This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of~     idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor~     control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible~     patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either~     idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary~     study therapy but experience definitive CLL progression are eligible to receive active~     idelalisib therapy in the extension study, GS-US-312-0117.~   "
154842|NCT01539499|"~     The goal of this study is to help better determine the complication rates for endocrine~     surgery across the nation for both benign and malignant disease. It is our hypothesis that~     the complication rates are low overall and that malignant disease results in a higher~     complication rate than benign disease. This study will do a database review from all~     University HealthSystem Consortium (UHC).~   "
154843|NCT01539486|"~     The intent for this study is to do a retrospective chart review of all patients who have~     undergone minimally invasive parathyroidectomy for primary hyperthyroidism. All data~     collected will be recorded under assigned identification numbers that will have no~     association with medical record or hospital numbers. Identifying characteristics will include~     age and sex. Anonymity will be upheld. The patient/family will not be contacted directly. All~     information will be obtained from the medical chart. Demographics, location, preoperative PTH~     levels and intraoperative Ex-Vivo gamma counts, co-morbid conditions, and the outcome based~     on the hospital notes will be obtained from patients' charts and will be transferred to a~     secure database. It is our hypothesis that there is a linear relationship between immediate~     preoperative parathyroid hormone (PTH) levels and Ex-Vivo gamma counts and the aim of this~     study is to better describe this relationship.~   "
154844|NCT01539473|"~     Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered~     with tyramine~   "
154845|NCT01539460|"~     Patients with axillary osmidrosis are treated with minimally invasive procedure combined~     tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in~     reducing odor is to be determined.~   "
154846|NCT01539447|"~     In a brief summary the study would like to evaluate the effectiveness of Naproxen in~     preventing radiographically detected heterotopic ossification following hip arthroscopy for~     the treatment of femoroacetabular impingement.~   "
154847|NCT01539434|"~     The purpose of this study is to investigate to what extent patients with COPD, who have~     participated in physical training for 12 weeks, can maintain their physical activity~     behaviour and physical capacity on a long-term basis if they get a behavioural medicine~     intervention.~   "
154848|NCT01539421|"~     This study was designed to evaluate the effectiveness of 12 weeks' home exercise training~     using the Nintendo ® Wii Fit system in patients with COPD. Following an initial pilot study~     at one institution to determine the physiological responses to exercise training using the~     home based interactive computer system, a longitudinal study was performed to evaluate~     outcomes across several areas. Outcomes were measured at baseline, after 6 weeks of standard~     care, and after 6 and 12 weeks of home exercise training. Three hospital based pulmonary~     rehabilitation centers in Connecticut participated in the longitudinal study.~   "
154849|NCT01539408|"~     Women diagnosed with incomplete abortion in this health facility will be randomized to~     receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard~     surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion~     with misoprostol using 400 mcg administered sublingually will be as effective as surgical~     evacuation.~   "
154850|NCT01539395|"~     This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple~     Sclerosis.~   "
154851|NCT01539382|"~     The purpose of this study is to test whether keeping the amount of oxygen delivered to the~     brain above a certain level during surgery and 24-hours after surgery improves recovery.~      Hypothesis 1: keeping the amount of oxygen delivered to the brain above a certain level~     during surgery and 24-hours after surgery improves cognitive and neurological outcomes after~     cardiac and aortic surgery.~      Hypothesis 2: keeping the amount of oxygen delivered to the brain above a certain level~     during surgery and 24-hours after surgery helps reduce major organ problems after cardiac and~     aortic surgery.~      To test our hypotheses, the investigators will conduct a randomized control trial. Patients~     will be randomly assigned to one of two possible study groups. In the Treatment Group, the~     brain oxygen level will be watched by doctors and used to guide care in the operating room~     and the first day in the intensive care unit after surgery. Doctors will try to keep the~     brain oxygen level in a normal range by adjusting your blood pressure, carbon dioxide and~     blood acidity levels, and blood count. In the Control Group, the doctors will not be aware of~     the brain oxygen level unless it falls below a level that may be dangerous. If a patient's~     brain oxygen falls below such a level, the doctors will adjust the blood pressure, carbon~     dioxide and blood acidity levels, and blood count to increase the brain oxygen level. All~     other procedures will be part of regular medical care and will be performed according to the~     standard of care.~   "
154852|NCT01539369|"~     The purpose of this parallel design study is to assess the relative effects of two 12-week~     healthy eating dietary interventions: general healthy eating (Diet A) and general healthy~     eating combined with advice to increase fibre intake (Diet B) to at least 25g/day (with a~     large proportion of the fibre intake derived from cereal or wheat bran), in overweight~     low-fibre consuming premenopausal female adults on body weight change (kg). It is~     hypothesized that adding fibre to a healthy eating diet (Diet B) would lead to greater weight~     loss and/or weight loss maintenance than following a healthy eating diet alone (Diet A).~   "
154853|NCT01539356|"~     A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of~     iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron~     retention in reticuloendothelial cells. The aims of this study were to determine serum~     hepcidin levels in preterm infants who receive blood transfusion and preterm infants having~     sepsis, in order to assess possible relationships between hepcidin and serum iron, serum~     ferritin,in iron load situations.~   "
154854|NCT01539343|"~     A CVC is a sterile flexible tube that allows a drug to flow from a bottle or bag directly~     into a patient's bloodstream. CVCs may cause infections when bacteria gets into the catheter~     and enters the bloodstream. They also have a risk of becoming clogged. When this occurs, the~     CVC usually needs to be replaced.~      The goal of this clinical research study is to learn if an antimicrobial catheter lock~     solution can make it possible for the CVC to stay in place while treating an infection with~     antibiotics. The safety of the solution will also be tested.~      Your outcome will be compared to the outcome of patients who had the same type of infection~     but had their CVC removed.~      The antimicrobial catheter lock solution is made up of 3 chemicals:~      Minocycline and ethanol are designed to disinfect the CVC. Disodium~     ethylenediaminetetraacetate is designed to prevent the CVC from clogging.~   "
154855|NCT01539330|"~     The present study aims at measuring unbound voriconazole concentrations in plasma and at the~     relevant target site of systemic fungal infections, i.e. the interstitial space fluid of soft~     tissues, to assess the target site pharmacokinetics. For this purpose the microdialysis~     technique will be employed which is capable of measuring the unbound, microbiologically~     active concentration of antifungals in the interstitial space fluid of virtually all tissues.~     This is the first human study of this drug employing the microdialysis technique determining~     the target site concentrations over several days (single and multiple dosing).~   "
154856|NCT01539317|"~     The purpose of this protocol is to determine whether pain with sexual intercourse can be~     reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a~     non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain.~      The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators~     predict that the localized use of lidocaine will be more efficacious than use of placebo~     liquid.~   "
154857|NCT01539304|"~     Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of CITUS Dry~     Syrup in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo~     Controlled, Parallel Designed, Multi-centered, Phase III Study.~   "
154858|NCT01539291|"~     This study (GS-US-312-0117) is a multicenter, 2-arm, double-blind, parallel-group extension~     study that is a companion study to Study GS-US-312-0116, to evaluate the effect of idelalisib~     on the onset, magnitude, and duration of tumor control.~   "
154859|NCT01539278|"~     In children, enlarged adenoids and/or tonsils are the most common cause of obstructive sleep~     apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the~     tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure the~     majority of children. However, for children with only a mild degree of OSA and few symptoms,~     surgery is less clear-cut, since two-thirds of these children do not develop worsening~     disease.~      Research shows that some children with mild OSA and behavior problems are helped by removing~     the tonsils and adenoids. In children with all degrees of OSA, surgery has improved scores on~     tests that measure quality of life (QOL).~      The investigators hypothesize that children with mild OSA will demonstrate changes on QOL~     assessment following adenotonsillectomy. These findings may help to guide the surgeon in~     selecting the children with mild OSA who are more likely to benefit from surgery.~   "
154860|NCT01539265|"~     The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary~     calculi patients.~   "
154861|NCT01539252|"~     The purpose of this study is to investigate the effectiveness of using two dialysers to lower~     the blood mineral levels in people receiving hemodialysis as compared to using one dialyser~     (usual treatment).~   "
154862|NCT01539239|"~     This clinical trial is a prospective, randomized, controlled, multicenter, study. After~     informed consent is obtained, patients will be evaluated for eligibility based on glaucoma~     severity, eye health, and visual acuity. Following successful screening, use of all topical~     glaucoma medications will be stopped for a period of washout to establish a qualifying~     medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over~     the course of the 24 month study, and examinations will be repeated to monitor eye health. At~     the 1 and 2 year follow up, those patients on ocular hypotensive medications will be~     instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and~     afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The~     primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24~     months diurnal IOP following medication washout.~   "
154863|NCT01539226|"~     This is a double-blind, randomised, placebo-controlled study to assess the safety and~     efficacy of a silicone elastomer vaginal matrix ring.~   "
154864|NCT01539213|"~     The proposed exploratory study aims to understand the in vivo skin distribution properties of~     subcutaneously (s.c.) administered AIN457 in psoriatic and healthy skin using open flow~     microperfusion (OFM). The data of this study will help to understand the mode of action of~     AIN457 in its target tissue.~      It aims to establish a technique assessing in vivo distribution of AIN457 and its metabolites~     in human dermal interstitial fluid (ISF) and exploring a potential pharmacodynamic effect in~     situ. In addition, the study will further evaluate safety and local tolerability of~     subcutaneously administered AIN457 and explore dermal interstitial fluid skin levels of~     potential disease relevant biomarkers.~      The study is divided into two parts - Part I with 8 healthy volunteers (HV) to validate the~     method is completed and Part II with 8 psoriasis patients will start based on the outcome of~     Part I.~   "
154865|NCT01539200|"~     Malnutrition and lack of regular exercise are often found in older adults and have been~     identified as important risk factors for independence loss and nursing home admission in~     older community-dwelling adults.~      Existing evidence suggests that high protein nutritional supplements can increase skeletal~     muscle protein synthesis following exercise in older individuals. However, increase of muscle~     strength by resistance training does not decrease the rate of falls and is not necessarily~     linked to an improvement of physical function. In contrast to resistance training, T'ai Chi,~     dance and eurhythmics have been shown to decrease fall incidence and improve mobility and~     physical function in older adults. The investigators will examine the combination of~     eurhythmics and high protein nutritional supplements.~      The aim of the study is to investigate whether there is an increase in normal walking~     velocity due to the nutritional supplement on top of once weekly Jacques-Delacroze~     Eurhythmics training.~   "
154866|NCT01539187|"~     The purpose of this study is to establish the effectiveness and confirm the safety of the~     VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.~   "
154867|NCT01539174|"~     This phase II trial studies how well giving rituximab together with combination chemotherapy~     works in treating patients with previously untreated high- or high-intermediate-risk diffuse~     large B-cell lymphoma (DLBCL). Monoclonal antibodies, such as rituximab, can block cancer~     growth in different ways. Some block the ability of cancer to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and~     prednisone (CHOP), work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving more than one drug, combination~     chemotherapy, may kill more cancer cells. Giving rituximab together with combination~     chemotherapy together may be an effective treatment for DLBCL~   "
154868|NCT01539161|"~     The study Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients~     with Chagas Disease is a prospective, multicenter, randomized study that is being conducted~     at several centers in Latin America with commercially available products.~      The primary study hypothesis is that patients with implantable cardiac monitors will have a~     shorter time to the decision to treat for electrical or arrhythmic disorders during the~     follow-up period.~      The geography includes Argentina and Colombia.~   "
154869|NCT01539148|"~     The investigator is looking for patients who have been diagnosed with stage 1-4 cancer to~     enroll in a five year Quality of Life clinical trial study in which the participant has~     previously elected to use Insulin Potentiation Targeted Low Dose (IPTLD) as a means to treat~     their illness. This study is a quality of life study and not a treatment study. Participants~     participating in the study will be asked to complete quality of life questionnaires. The~     questionnaires completed by the patients will measure mood, energy level, ability to~     function, level of pain, and other measures that indicate how a patient feels about the~     quality of their daily living.~   "
154870|NCT01539135|"~     Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe~     while under general anesthesia. These tubes have a cuff on the outside that is inflated in~     the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different~     shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that has been~     shown in animals to decrease the leakage of fluid past the cuff better than a traditional~     tube that has a barrel-shaped cuff. This study is designed to examine whether the use of the~     TaperGuard tube during surgery on humans decreases the amount of leakage past the cuff to a~     greater degree than the traditional barrel-shaped cuff. In addition, the study will~     investigate whether the use of the TaperGuard tube is associated with a decrease in~     respiratory complications often seen following surgery which may be related to fluid leaking~     past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal~     tube will result in a decrease in fluid leakage past the cuff and that it will be associated~     with a decrease in respiratory complications during the 30 days after surgery.~   "
154883|NCT01538966|"~     In this study the investigators will evaluate whether combination low dose somatostatin~     receptor ligand (SRL) and weekly or daily Pegvisomant will attain equivalent control of serum~     IGF-1 levels, compared to combination high dose SRL and weekly Pegvisomant. Lower doses of~     therapy will greatly reduce cost of acromegaly therapy.~   "
154981|NCT01537692|"~     The purpose of this study is to compare the systemic levels of beclomethasone 17~     monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP~     HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in~     healthy volunteers.~   "
154871|NCT01539122|"~     The objective of this randomized controlled study is to obtain outcomes data on the Zimmer TM~     glenoid component by analysis of standard scoring systems and radiographs in comparison to~     the cemented glenoid component. In addition, the investigators plan to provide cost analysis~     based on the economic data collected to justify the cost difference between both implants.~      Patients with acceptable glenoid bone stock will be randomized into two groups to be treated~     with either a TM Glenoid or cemented glenoid component with minimum 2 years follow-up;~     maximum 10 years follow-up.~      Hypothesis: The early and long-term clinical outcomes and radiographic analysis of the TM~     glenoid components are superior to the cemented glenoid components in total shoulder~     arthroplasty patients.~   "
154872|NCT01539109|"~     The purpose of this study is to investigate whether combining a noninvasive method of brain~     stimulation, called Transcranial Direct Current Stimulation (tDCS), enhances the effect of~     training of the affected upper limbs in patients with incomplete Spinal Cord Injury.~   "
154873|NCT01539096|"~     The purpose of this study is to investigate whether benefits of training the affected hand in~     patients with stroke can be improved by combining training with a painless, noninvasive~     technique called Transcranial Direct Current Stimulation (TDCS). TDCS will be applied over~     the part of the brain responsible for movements of the affected hand. Also, the investigators~     will study the changes in the brain that favor recovery of hand function following~     combination of training and tDCS.~   "
154874|NCT01539083|"~     The purpose of this study is to determine if bortezomib when added to consolidation treatment~     with thalidomide and prednisolone leads to an improved response in patients with multiple~     myeloma who have undergone autologous stem cell transplant and initial treatment with~     bortezomib, cyclophosphamide, and dexamethasone.~   "
154875|NCT01539070|"~     The purpose of this study is to develop, implement and evaluate an intervention focused to~     change feeding practices and patterns of physical activity of preschool children through~     providing motivational counseling to the mother. The aim is to prevent obesity in children~     aged 2 to 4 years 11 months with risk of overweight or with overweight.~   "
154876|NCT01539057|"~     Objective:~        -  To evaluate the efficacy of preoperative administration of fibrinogen in liver~          transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared~          with placebo, reflecting a reduction in the number of RBC units transfused during the~          procedure.~        -  To determine the influence of fibrinogen administration on mortality and survival of~          liver graft evaluated one year after the procedure.~        -  To determine the safety of fibrinogen administration recording thrombotic complications~          evaluated during hospitalization or at least 30 days postoperatively.~   "
154877|NCT01539044|"~     Muscle relaxation using rocuronium infusion with sugammadex reversal hypothetically provide~     better quality of muscle relaxation and rapid recovery from anaesthesia compared with~     intermittent bolus of rocuronium muscle relaxant which is reversed with neostigmine.~      50 patients undergoing major laparotomy surgery with predicted surgical time of more than 90~     minutes will be randomised into 2 treatment arms: CI-sugammadex & IB-Neostigmine.~      After a bolus of rocuronium given during induction, patients in CI-Sugammadex arm will be~     started on rocuronium infusion immediately and rate adjusted according to the targeted PTC of~     1-2. Patients randomised to IB-Neostigmine will be given boluses of rocuronium at~     reappearance of TOFC of 2.~      At the end of the surgery, the subject will be reversed with either sugammadex or neostigmine~     at different depth of block, ie PTC 1-2 and TOFC 2 respectively.~      Quality of intraoperative relaxation and effectiveness of reversal of the 2 technique,~     CI-Sugammadex and IB-Neostigmine will be compared with respect to:~        1. Time to full reversal (T4/T1 [TOF] ratios ≥ 0.9) of neuromuscular blockade from:~             -  PTC 1-2 in CI-Sugammadex group~             -  TOFC ≥2 in IB-Neostigmine group~        2. Incidence of residual neuromuscular blockade (T4/T1 ratios < 0.9)~        3. Improved quality of intraoperative neuromuscular relaxation by maintaining profound~          neuromuscular blockade, as reflected by reduced incidence of intraoperative events and~          high VAS grading of relaxation quality by surgeon~   "
154878|NCT01539031|"~     The purpose of this study is to compare 23 mg donepezil sustained release to the currently~     marketed formulation of 10 mg donepezil immediate release in patients with severe Alzheimer's~     disease.~   "
154879|NCT01539018|"~     -  Unlike the Asian and western regions, The vast majority of the Egyptian/Arabic~          Hepatocellular Carcinoma (HCC) patients are hepatitis C virus (HCV) associated.~        -  According to the SHARP study subgroup analysis, it seems that HCV associated HCC~          patients derive the max benefit of Sorafenib, the absolute gain between the Sorafenib~          arm & the placebo in m OS = 7 months, HR=0.58 (95% CI: 0.37-0.91).~        -  In spite of improvement in terms of overall survival (OS) and time to progression (TTP),~          in all studies where Sorafenib was compared to placebo, the Sorafenib arm was not~          accompanied by a significant volumetric reduction, and this may explains the lack of any~          symptomatic improvement (time to symptomatic progression (TTSP) almost identical)~        -  Reviewing the chemotherapy outcome, although there is no convincing evidence in survival~          benefit to patients with advanced HCC, however true shrinkage (reduction in tumor size),~          has been consistently reported although the magnitude of response is lacking~          consistency.~      This indicates the need for coupling Sorafenib to a chemotherapeutic agent but:~        -  For patients with Hepatocellular Carcinoma, the toxicity profile of any chemotherapeutic~          agent of choice to be added to Sorafenib should be take in consideration~        -  The agent to be added to Sorafenib should be effective in terms of Tumor Shrinkage &~          with minimal toxicity regarding:~        -  Cardio-toxicity~        -  HFSR~        -  Diarrhea~        -  Hepato-toxicity~        -  Bone marrow suppression (although not relevant to the toxicity profile of Sorafenib, yet~          the HCC patients may have HCV related thrombocytopenia and variable degree of~          hypersplenism related pancytopenia)~      Circulatory Overload (Hypertension) Why Tegafur-uracil (UFT)?~        -  Efficacy: For UFT, although the efficacy data in HCC are not as extensive as~          Doxorubicin, however in one phase II study UFT could improve survival when compared with~          conservative management.~        -  UFT Toxicity Profile:~      In a phase III trial to asses the compare Efficacy & Safety of UFT with that of 5 FU in~     treatment of m CRC, Hematological toxicities were minimal (0% Grade ¾ leukopenia,~     neutropenia, febrile neutropenia, thrombocytopenia & was 3% for anemia), while the most~     commonly seen SE was grade I & II Diarrhea~      •Accordingly UFT may be considered as a potential partner to Sorafenib in patients with~     advanced HCC.~   "
154880|NCT01539005|"~     This is a cohort observational study investigating the rate of tuberculosis (TB) recurrence~     in adult patients who have completed TB therapy for Pulmonary TB (PTB) and are on highly~     active antiretroviral therapy (HAART).The primary objective of this study is to determine the~     incidence of TB recurrence in patients on HAART.The study is being conducted at the CAPRISA~     eThekwini Clinical Research Site (CRS), which is adjacent to the Prince Cyril Zulu~     Communicable Disease Clinic (PCZCDC), a major urban TB clinic, in Durban, South Africa.No~     hypotheses will be tested in this study; however, the primary study question will determine~     the proportion of TB recurrence due to relapse vs. re-infection.The study has enrolled 402~     participants~   "
154982|NCT01537679|"~     The purpose of this study is to determine whether meditation will reduce stress and~     depressive of adult caregivers of a person with dementia.~   "
154884|NCT01538953|"~     This study is designed to evaluate the effect of different methods of drinking water~     treatment on the occurrence of diarrhea among children living in squatter settlements in~     Karachi, Pakistan, and the marginal benefit of adding handwashing to water treatment. 260~     households will receive a new product which combines flocculation with chlorination to~     produce clearer, less chemically contaminated drinking water. 260 households will receive~     dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive~     soap and encouraged to wash their hands regularly. 260 households will receive both soap and~     the combination flocculation/chlorination water treatment. 260 households will continue their~     standard water treatment and handwashing practices. The households will be visited each week~     for 9 months, and the episodes of diarrhea from each child in the household recorded. The~     rate of diarrhea between the groups will be compared. At the end of 9 months, households who~     were part of the standard habits and practice group will receive a water storage vessel and~     disinfectant.~   "
154885|NCT01538940|"~     This study will assess the efficacy of a new intradermal formulation of the trivalent~     inactivated influenza vaccine compared to the standard intramuscular vaccine in HIV-infected~     men who have sex with men in Bangkok, Thailand. Relative efficacy of the two different~     formulations of influenza vaccine will be assessed by comparing immunologic responses to~     vaccine between the two study arms.~   "
154886|NCT01538927|"~     The aim of this randomized controlled clinical trial is to compare wound healing after the~     use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for~     their periodontal (gum)problems are selected and invited. Two regions will be operated in a~     selected patient. One region will receive fibrin sealant (test site) and the other region~     will get sutures (control site). Wound healing will be assessed by evaluating inflammatory~     markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid.~      Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels~     of interleukin (1beta and 8) compared to use of sutures.~   "
154887|NCT01538914|"~     The purpose of this study is to compare the analgesic effect of paravertebral block with that~     of intravenous patient-controlled analgesia after video assisted thoracic surgery.~   "
154888|NCT01538901|"~     The purpose of this study is to compare two different therapies for actinic keratoses in~     organ transplant recipients with regard to efficacy and tolerability. The investiagtors are~     planning to examine treatment with Imiquimod 5% cream versus treatment with~     Methyl-aminolaevulinate 16% cream and subsequent irradiation with red light, so-called~     photodynamic therapy, in this patients' group. A secondary objective of our study is to~     investigate the reduction in the field cancerisation after both treatments using fluorescence~     diagnostic method and digital imaging.~   "
154889|NCT01538888|"~     This study makes sure that the training of whole body vibration induces changes in~     ergospirometric parameters, in strength and influence in quality of life in healthy elderly.~     A case that is run like a vibration training combined, increasing strength and VO2.~   "
154890|NCT01538875|"~     Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure >~     110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with~     severe and even deadly consequences. The management in this population had been studied, but~     no consensus has been reached with regards to which treatment is better. Our study will~     compare two drugs: Hydralazine and Labetalol for the management of hypertensive crisis.~   "
154891|NCT01538862|"~     This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is~     effective as a treatment of Dystrophic Epidermolysis Bullosa (EB). Patients will receive one~     course of treatment with the study drug. The course will be 7 days in length. After receiving~     GCSF, patients will be followed at 7 and 30 days following the discontinuation of the drug.~     Thirty day follow up can be done via telephone communication with the patient or family.~   "
154892|NCT01538849|"~     This study is to investigate the optimal clinical dose and administration methods of YH4808~     in patients with reflux esophagitis by evaluating the safety and efficacy after YH4808 oral~     administration.~   "
154893|NCT01538836|"~     The purpose of this study is to determine whether consuming additional protein during calorie~     restriction induced weight loss has beneficial or harmful effects on multi-organ (liver,~     muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut~     microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal~     women.~   "
154894|NCT01538823|"~     The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis~     of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective,~     screening techniques.~   "
154895|NCT01538810|"~     The purpose of this study is to assemble a collection of urine and blood samples for the~     development and validation of biomarkers potentially useful in correlating or improving the~     diagnostic utility of abdominal imaging.~   "
154896|NCT01538797|"~     The objectives of the study were:~        -  To compare a single dose of YF476 at 3 dose levels, placebo and ranitidine with respect~          to their effects on basal- and food- stimulated gastric pH in healthy volunteers.~        -  To assess whether there is a relationship between the pharmacokinetics of YF476 and~          gastric pH in healthy volunteers.~        -  To assess the safety and tolerability of single doses of YF476 in healthy volunteers.~   "
154897|NCT01538784|"~     The objectives of the study were:~        -  To assess the safety, tolerability and pharmacokinetics of YF476 in healthy volunteers.~        -  To select a dose or doses of YF476 for detailed pharmacodynamic studies in healthy~          volunteers.~   "
154919|NCT01538498|"~     -  Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer,~          tubal cancer and primary peritoneal cancer that can represent perioperative~          intraperitoneal tumor burden objectively~        -  Secondary objectives: To establish the relationship and find out clinical significance~          between PCI, tumor location and tumor characteristics~   "
154920|NCT01538485|"~     In this pilot study the investigators aim to investigate the effects of vitamin D~     supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women~     and men.~   "
154921|NCT01538472|"~     The goal of this clinical research study is to see if high-dose chemotherapy (BEAM) and~     rituximab, given together with the new drug 90Y Zevalin, followed by a transplant of blood or~     marrow stem cells is safe. Another goal is to learn if this treatment can help decrease the~     chances of the cancer coming back.~   "
154898|NCT01538771|"~     Prospective, randomized and open label trial~      Hypothesis~        -  Infusion of intracoronary darbepoetin-alpha at the time of reperfusion may reduce~          infarct size and post-infarct pathologic left ventricular remodeling in patients with~          ST-segment elevation myocardial infarction.~      Methods~        -  Randomization into control group or treatment group~        -  Treatment group : Darbepoetin-alpha 300ug intracoronary bolus infusion via over-the-wire~          balloon system simultaneously with first balloon inflation and conventional treatment~        -  Control group : conventional treatment~      Endpoints~        -  peak CK-MB & troponin levels : baseline,6h,12hr,18hr, 24hr, 36hr and 48hr~        -  MRI at baseline : infarct size, area at risk and salvaged myocardium~        -  MRI at 4 months : prevalence of pathologic left ventricle remodeling (definition:~          increase of end-diastolic volume index > 20% compared to baseline)~        -  safety endpoint : cardiac death, nonfatal myocardial infarction, stent thrombosis,~          ischemic stroke, hospital readmission with heart failure or ischemic symptom, bleeding~          and urgent target lesion revascularization~   "
154899|NCT01538758|"~     Ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain~     due to calcifying tendinitis. However, evidence for this treatment is lacking. The~     investigators expect that patients treated with us guided needling with corticosteroid~     injection compared with patients treated with only corticosteroid injections in the~     subacromial bursa have better clinical outcome after one year follow-up.~   "
154900|NCT01538745|"~     The purpose of this study is to compare the safety and effectiveness of intravenous low dose~     ketamine to the industry standard of morphine in regards to controlling acute pain in the~     emergency department.~      Both LDK and morphine have side effects. The amount and character of these side effects will~     be compared. Additionally, the degree of sedation or agitation will be specifically measured.~     The aim of this current study is to make this comparison and shift the evidence for LDK use~     from the anecdotal to the scientific.~   "
154901|NCT01538732|"~     This is a single center, prospective, open label, single arm, investigator initiated pilot~     study investigating the effect of alitretinoin on severe lichen planus with mucosal~     manifestations. The target population comprises patients with MLP for at least 3 months, with~     or without LP lesions on other areas of the skin, who are refractory to topical therapy and~     standard skin care, and who are otherwise in good health. Patients will be recruited at the~     outpatient clinic of the dermatology department, University hospital Zurich.The planned~     duration of the study is 2 years. A total of 20 patients will be included. Patients who meet~     enrolment criteria will receive 30mg alitretinoin, given orally as gelatin capsules, once~     daily for 24 weeks. Dose interruptions are permitted in response to adverse effects,~     consistent with use of retinoids and the product label.~      Most clinical evaluations will be performed every 4 weeks. A safety follow-up visit is~     planned 4 weeks after the end of treatment. Further follow-up visits will be conducted 16 and~     24 weeks after end of treatment in those patients meeting the primary endpoint~        -  Trial with medicinal product~   "
154902|NCT01538719|"~     Scleroderma,also known as systemic sclerosis (SSc), is a multisystem disease affecting skin~     and other tissues including joints, muscles, lungs, the gastrointestinal tract and kidneys~     and tissue fibrosis is widespread. SSc presents special problems for developing therapies due~     to the heterogeneous clinical presentation, the variability of disease progression and the~     difficulty quantifying the extent of disease. For most disease manifestations, treatment is~     primarily symptomatic and generally inadequate.~      This study will utilize a 4-gene biomarker of skin disease as the primary efficacy outcome in~     a short duration, placebo-controlled clinical trial of rilonacept, designed to provide~     preliminary data for a larger trial. These gene biomarkers should provide a strong surrogate~     for such trials in the future and, if IL-1 is indeed the cytokine leading to fibrosis in this~     disease, provide a highly significant start to finding a therapeutic for SSc that for the~     first time might dramatically affect fibrosis. A central hypothesis of this study is that~     IL-1 inhibition will downregulate the 4-gene biomarker over a relatively short period of~     time, much shorter than is historically thought necessary to see changes in the MRSS, a skin~     score measurement tool. Entry criteria will include the recent onset of diffuse cutaneous SSc~     as this is the population most likely to show progressive skin disease and also the~     population examined in previous studies showing correlations between MRSS and the 4-gene~     biomarker.~      Secondary outcomes will include other validated measures of SSc disease activity. MRSS and~     SSc health assessment questionnaire (SHAQ), will be followed during the trial. This study~     will also test the effect of rilonacept on global skin gene expression using microarray~     analyses of skin biopsies. In addition, serum biomarkers of SSc disease activity (COMP, THS-1~     and IFI44) and a biomarker of inflammasome activation (CRP) will be tested before and after~     treatment.~   "
154903|NCT01538706|"~     The purpose of this non-randomized controlled intervention study was to evaluate the effects~     of a hospital-based home care program for children with cancer at a university hospital in~     Denmark. The hypothesis was that hospital-based home care could replace an out-patient visit~     or an in-patient admission without increasing the incidence of adverse events and costs.~     Furthermore, to enhance the children's quality of life and the psychosocial impact on the~     family.~   "
154904|NCT01538693|"~     The purpose of this study is to determine whether exercising (walking) at different~     intensities increases levels of factors in the blood and saliva that are known to impact~     neuroplasticity (how the connections in the spinal cord and brain can change) and if these~     levels are changed by pairing exercise with a single dose of commonly used prescription drugs~     or by your mood.~   "
154905|NCT01538680|"~     This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study~     to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have~     failed after standard therapy and for whom no therapy alternatives exist, in the time between~     positive results and approval / availability on the market, and to collect safety data for~     regorafenib until market access.~      Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase~     inhibitor targets certain key proteins that are essential for the survival of the cancer~     cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The~     growth of the tumor may be decreased by preventing these specific proteins from functioning.~      The primary endpoint of this study will be safety.~   "
154922|NCT01538459|"~     The purpose of this study is to determine the Finger Blood Glucose (sugar) when dexamethasone~     is added to a local anesthetic for a shoulder nerve block procedure. The investigators~     hypothesize that there is no increase in plasma glucose when 8 mg of dexamethasone is used as~     an adjuvant with local anesthetic to interscalene regional anesthesia. By performing finger~     stick blood glucose measures pre/peri and post operatively the investigators will be able to~     determine if any such increase exists.~   "
154983|NCT01537666|"~     The study is carried out to evaluate the safety, tolerability and pharmacokinetics of~     AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.~   "
154906|NCT01538667|"~     The purpose of this study is to characterize variability and extent of the deposition of~     ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with~     chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg~     active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be~     evaluated. In this study the radiolabeled substance will be administered and scintigraphy~     imaging techniques will be used to demonstrate the lung deposition visually. In the healthy~     subjects an additional pharmacokinetic method is used to calculate lung deposition indirectly~     based on pharmacokinetic data derived from plasma. For this purpose they will inhale at a~     separate occasion another dose of ciprofloxacin after having ingested activated charcoal. The~     latter serves to bind ciprofloxacin which is swallowed down during the inhalation maneuver in~     the gastrointestinal (GI) tract, thus preventing its uptake into the blood (charcoal block).~     Safety investigations will focus on local tolerability in the lung.~      Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the~     study drug.~      Results from this study will be used to show how the drug is distributed in the human lung.~   "
154907|NCT01538654|"~     The purposes of the esperience is:~        1. to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF~          )performed in cycles of ten days/months for six months~        2. to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance,~          polmonary function tests and metabolic pattern)~        3. to verify the weight mantainance after 6 months from the treatment suspension~   "
154908|NCT01538641|"~     Study Proposal:~      Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol,~     Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior activity~     as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin is more~     attractive and should be explored in this group of disorders. Based on these data and~     considering the advantage of its favorable toxicity profile, we propose a phase II study in~     patients with either refractory or relapsing aggressive non-Hodgkin's lymphomas including~     peripheral T-cell lymphomas which are known to have a poor outcome when compared with~     equivalent aggressive B-cell lymphomas.~   "
154909|NCT01538628|"~     The purpose of this study is to evaluate the safety of the SpaceOAR System when the hydrogel~     is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT) and~     to evaluate whether use of the SpaceOAR hydrogel results in a reduction of radiation exposure~     to the anterior rectum.~   "
154910|NCT01538615|"~     The goal of the proposed project is to see if an innovative family-based intervention can~     reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors~     in the home. In additions, the project will also examine how the HOME Plus family~     intervention influences children's dietary intake, frequency of family meals, availability of~     healthy and unhealthy foods in the home and served at meals and snacks, and screen time (TV,~     game systems). The study will provide important information on strategies that families can~     use at home to prevent obesity.~   "
154911|NCT01538602|"~     Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and~     hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia~     and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term~     cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the~     thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of~     metabolic outcomes in PCOS patients is compared to a placebo group.~   "
154912|NCT01538589|"~     This study is conducted in Japan. The aim of this study is to evaluate the incidence of~     severe hypoglycaemia under normal clinical practice.~   "
154913|NCT01538576|"~     This study is conducted in Japan. The aim of this study is to collect safety and efficacy~     data when using insulin aspart in children with diabetes under normal clinical practice~     conditions.~   "
154914|NCT01538563|"~     The primary purpose of this study is to determine the highest dose of ON 01910.Na that can be~     safely given as an intravenous infusion over 24 hours once a week in a 3-week cycle to~     patients with advanced solid tumors.~   "
154915|NCT01538550|"~     The Norwegian government has funded a pilot study of a national colorectal cancer screening~     programme. This implies initiation of a screening pilot in the catchment area for two~     hospitals in Norway. The target population is average risk men and women at age 50-74 years.~     The programme is designed as a comparative effectiveness programme evaluating acceptance and~     test performance for two screening methods - fecal occult blood testing (FOBT) and flexible~     sigmoidoscopy (FS). This protocol describes the main methodological issues, necessary~     resources and the expected effects.~   "
154916|NCT01538537|"~     The primary objective of this study is to determine the largest dose of ON 01910.Na~     (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2~     weeks (2-week cycle) in patients with advanced cancer.~   "
154917|NCT01538524|"~     Patient safety is a great concern for the whole society. Since the investigators have a~     leadership in the medical field in Taiwan, the investigators should be courageous to face the~     reality from the patients seeking second opinions undergoing orthodontic treatment.~      Orthodontics just became a recognized specialty by the Department of Health in Taiwan in~     2009. It is just a beginning to set up the training course criteria at the national level. It~     will be a good timing for us to look at the treatment quality when patients seeking second~     opinions at NTUH. Whether the unsatisfied results are from the patient's unrealistic~     expectation, patient's compliance issue, doctor's diagnosis, treatment planning or skills, or~     a simple communication problem, depend on a good systemic analysis from the records and~     questionnaire collected in a timely fashion.~      The investigators plan to ask patients who are undergoing full-mouth orthodontic treatment~     and seeking second opinion to join this study. The investigators will thoroughly explain to~     patients before they agree to take records and fill in questionnaire. Then the investigators~     use these records to perform root cause analysis.~      Our hypothesis is that the risk of adverse event (AE) is related to the training quality,~     communication skills, patient's understanding and compliance. From these results, the~     investigators shall be able to assess the risk of AE and make the education policy either at~     continued education level or special training courses towards a patient satisfied treatment.~   "
154918|NCT01538511|"~     This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin aspart~     70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30~     (NN-X14Mix30) in healthy volunteers.~   "
154923|NCT01538446|"~     The purpose of this study is to demonstrate the superiority of a strategy of platelet~     monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders~     and up-adjustment of the dose of prasugrel in low responders as compared to a more~     conventional strategy of a fixed dose of 5 mg to every patient without monitoring~     (Conventional Arm) as measured by a reduction in the composite endpoint of, cardiovascular~     (CV) death, myocardial infarction (MI) , stroke, stent thrombosis (ARC definition type~     definite), urgent revascularisation or bleeding (BARC definition type 2, 3 or 5).~   "
154924|NCT01538433|"~     This is a survey of factors which affect a pathologically defined early or delayed diagnosis~     of IgA nephropathy in Guangdong General Hospital, Guangzhou, China. An early or delayed~     diagnosis of IgA nephropathy is pathologically defined using the recently published Oxford~     classification of IgA nephropathy. The factors to be surveyed include health examination~     including urine test, socioeconomic status of patients including education,etc.~   "
154925|NCT01538420|"~     GLPG0492 is a selective androgen receptor modulator: the compound should help protect against~     (or help restore) muscle loss in case of immobilization (e.g. after orthopedic surgery) or~     due to aging (androgenic effect), but without anabolic effects (e.g. effect on testosterone).~     In the first part of the current study it will be tested whether GLPG0492 given orally to~     healthy male volunteers increases the protein synthesis in muscle, as measured by the uptake~     into the muscle of intravenously infused phenylalanine.~      In the second part of the study, the effect of the compound on the hormone household in~     healthy, postmenopausal women will be assessed.~   "
154926|NCT01538407|"~     This is a longitudinal, randomized, controlled interventional multi centric study on the~     effects of lower leg strengthening exercise on quadriceps force during walking in people with~     knee osteoarthritis. At each study centre twenty subjects will be included, for a total of 40~     participants. Subjects will be randomized equally (1:1) into 1 active arm and 1 control arm.~      The objective of the study is to evaluate the effect of twelve weeks of quadriceps~     strengthening on the mechanical output of the quadriceps during locomotion. A secondary~     purpose is to explore the relationship between quadriceps strengthening and compressive knee~     loadings. The hypothesis is that quadriceps strength training will not change quadriceps~     force, power, and work in locomotion in people with knee osteoarthritis.~      Primary outcome is quadriceps force during walking, secondary outputs are quadriceps power~     and work and knee compressive loads during walking. Explorative measures are isometric and~     concentric isokinetic leg muscle strength, radiographic score of the knee (Kellgren and~     Lawrence), a one-leg rise from chair test (maximum number of reps) and a lateral step-up test~     (maximum number of reps).~   "
154927|NCT01538394|"~     The purpose of this study is to assess the efficacy of smoking cessation by using varenicline~     as monotherapy (VRN + placebo patches) or combined therapy (VRN + nicotine patches).~   "
154928|NCT01538381|"~     The general objectives are to evaluate the pre-operative activity and the safety of afatinib~     in head and neck cancer and to explore the different downstream molecular pathways to~     identify tumor response and resistance mechanisms. The results from this study can be used to~     conduct a larger trial that would allow us to confirm or validate the hypotheses generated.~   "
154929|NCT01538368|"~     The interpretation of Magnetic Resonance Cholangio-pancreatography (MRCP)-findings is~     primarily performed by radiologists who only in some cases have experience with the~     interpretation of endoscopic retrograde cholangiopancreatography (ERCP)-images. It is unclear~     if MRCP-interpretation by the radiologist is sufficient to decide which additional endoscopic~     procedures might be necessary in an individual case or if an additional MRCP-interpretation~     by the endoscopist renders any clinical impact.~   "
154930|NCT01538355|"~     It is well accepted that nutrition as an environmental factor is involved in the pathogenesis~     of multiple sclerosis. But is there a role for prolonged fasting and ketogenic low glycemic~     load treatment to alter the course of multiple sclerosis (MS)? The investigators think yes~     there is. Primarily the investigators want to detect if these diets are feasible for MS~     patients. Therefore the investigators examine the impact of this dietary intervention on the~     health related quality of life for individuals after 7 days, 3 months and 6 months in compare~     to baseline. Secondarily the investigators focus on endocrinological and immunological~     changes after 7 days, 3 months and 6 months in compare to baseline.~   "
154931|NCT01538342|"~     Psoriasis is a chronic autoimmune disorder of the skin. In this disease, the inflammatory~     caspases, cysteine proteases involved in the processing of many proteins, are activated.~     Transgenic mice expressing the cleaved form of caspases by Lyn, a tyrosine kinase Src family,~     develop an inflammatory syndrome with the characteristics of human psoriasis.~      To clarify the relationship between the cleaved form of Lyn by caspases and psoriasis, the~     investigators intend to develop a clinical study to analyze the expression, cleavage and~     activity of Lyn and the activation of caspases from skin biopsies of patients with this~     disease.~      This study will be conducted on a cohort of patients with different forms of psoriasis~     (plaque, pustular and erythrodermic) and atopic dermatitis, another skin disorder associated~     with chronic inflammation. Thus, the investigators will evaluate the expression and activity~     of Lyn from skin lesion (L) and non-lesional (NL) from the same patient in parallel with the~     level of caspase activation and apoptotic inflammatory.~      Thus, the investigators will verify that the cleavage by caspases of Lyn is associated~     specifically with psoriasis, as the investigators believe, or more generally to the skin~     inflammation. The investigators work would then define the cleavage by caspases of Lyn as a~     new potential marker of human psoriasis.~   "
154944|NCT01538173|"~     In this prospective study we investigated the impact of an improved postoperative~     microcirculation and its effect of surgical side infections after breast reduction.~   "
154945|NCT01538160|"~     Lately the investigators found that patients with severe factor XI deficiency and inhibitors~     could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic~     agent. These results encourage us to apply this treatment in clinical trial setting to~     patients with severe factor XI deficiency undergoing surgery instead of blood product.~   "
154946|NCT01538147|"~     Restless Leg Syndrome is a common but not well recognized central nervous system disorder. It~     is more prevalent during pregnancy and, if present before pregnancy, can develop an~     exacerbation of symptoms. In some of the hypothesis trying to explain this syndrome, the~     physiopathology can also explain hypertensive disorders of pregnancy. So far, no study has~     been done trying to link both disorders.~   "
154932|NCT01538329|"~     Traditionally amantadine is used at the beginning of Parkinson Disease (PD) treatment in the~     early stages of the disease, as a modest antiparkinsonian symptomatic treatment. This~     treatment is usually maintained for no more than the first few months of management, before~     resorting to drugs deemed more effective as dopamine agonists and lévo-DOPA (L-DOPA). A more~     modern use of the drug is at a more advanced stage of PD when dyskinesia are already~     established and become disabling for the patients. There is no data between these two~     extremes of life stages of Parkinsonism. However, the mechanisms of action of amantadine and~     the pathophysiology of the motor complications induced by L-DOPA, in particular dyskinesia~     suggest that the early and prolonged use of amantadine in the early years of management,~     before L-DOPA-induced dyskinesia have already emerged, should have a positive impact on~     long-term occurrence and fate of these symptoms, possibly through a glutamatergic mechanism~     of brain plasticity-of the disease modification type.~      The primary purpose of this study is to demonstrate that early introduction of treatment with~     amantadine (200 mg / d) in the early years of therapeutic care, that is to say during the~     honeymoon of levodopa (early phase of disease <3 years of diagnosis <1 year of L-dopa and~     lack of complications of levodopa therapy) decreases the rate of subjects with abnormal~     involuntary dyskinetic movements after 18 months of follow-up.~   "
154933|NCT01538316|"~     The aim of the randomized controlled double-blind crossover trial is to evaluate the~     effectiveness of two dietary supplements containing polyphenolic phytochemicals (isoflavonoid~     genistein and flavonoid quercetin) in comparison with placebo on the rate of increase in~     prostate-specific antigen (PSA). In addition, secondary objective is to evaluate the~     incidence of prostate cancer and to analyze malondialdehyde and protein carbonyle as~     indicators of the oxidative status.~   "
154934|NCT01538303|"~     The purpose of this study is first to evaluate absolute myocardial blood flow and resistance~     over time in the acute and sub-acute phase of myocardial infarction and second, to correlate~     these parameters to preservation of left ventricular function and long-term outcome.~   "
154935|NCT01538290|"~     The investigators want to validate two non-invasive devices for the determination of central~     blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).~   "
154936|NCT01538277|"~     The knowledge of the real-time contact force leads to a greater reduction in atrial~     fibrillation burden after pulmonary vein antrum isolation.~   "
154937|NCT01538264|"~     The investigators are studying the use of an advanced magnetic resonance imaging (MRI)~     technique for measuring blood flow into brain tumors. This technique does not use radioactive~     tracers, and it can provide high quality images that can be obtained in a standard MRI~     scanner.~   "
154938|NCT01538251|"~     The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine~     modified release tablets 1g/die in reducing the symptoms of the disease with respect to the~     proportion of patients with disease remission at the end of the 8 weeks of treatment. It will~     also aim to investigate capability of the treatment in the maintenance of remission after~     four weeks of treatment interruption; histological changes will be also evaluated and~     finally, improvement in the overall quality of life as measured by the Short Inflammatory~     Bowel Disease Questionnaire (SIBDQ)will be investigated.~   "
154939|NCT01538238|"~     Recent advances in understanding the biology and genetics of renal cell carcinoma (RCC) have~     led to major therapeutic implications. Von Hippel-Lindau (VHL) gene inactivation, present in~     the majority of sporadic forms of RCC, leads to a defective VHL protein, followed by an~     active transcription of hypoxia-inducible genes, including vascular endothelial growth factor~     (VEGF), platelet-derived growth factor (PDGF), c-kit, and others. However, the concept of VHL~     inactivation in RCC and the subsequent malignant phenotype is almost exclusively seen in~     patients with clear cell histology.~      The data about efficacy of VEGF receptor inhibitors for non-clear cell RCC (NCRCC) is rare~     until now. Recently, however, sunitinib and sorafenib showed its worth for NCRCC in extended~     access programs.1-3 Although it is not certain, the underlying mechanism of their action~     might lie in that papillary, chromophobe, and sarcomatoid type overexpress c-kit, which is~     also a target of both drugs and could therefore provide a therapeutic target for non-clear~     cell subtypes.4-7 Pazopanib is also a potent and selective, orally available, small molecule~     inhibitor of VEGFR-1,-2, and -3, PDGF-α, PDGF-β, and c-kit tyrosine kinases. It has been~     validated and licensed for advanced clear cell RCC (CCRCC).8 However, there is very few data~     about its efficacy for NCRCC.~      In this study, we try to evaluate the efficacy of pazopanib in metastatic NCRCC.~   "
154940|NCT01538225|"~     Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate~     cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with~     secondary or primary progressive Multiple Sclerosis (MS).~   "
154941|NCT01538212|"~     This evaluation of the efficacy and safety of AXONA will be a chart review carried out at 16~     practices in which AXONA has been prescribed for the treatment of patients with~     mild-to-moderate AD. Efficacy of AXONA will be assessed by comparison of patient status~     before and after initiation of treatment.~   "
154942|NCT01538199|"~     The purpose of this study is to see if using Transcranial LED Therapy (TLT) using the~     PhotoMedex's Omnilux NEw-U LED helps improve symptoms of major depressive disorder (MDD). TLT~     works by briefly delivering near-infrared (non-visible) radiations to the forehead. The~     radiations penetrate the brain and stimulate the cells & metabolism.~      Our goals are~        -  To assess the antidepressant effect of the TLT in depressed subjects.~        -  To assess the safety and tolerability of the TLT in depressed subjects~        -  To assess the acceptability of the TLT in depressed subjects~        -  To pilot test the impact on cognition of the TLT in depressed subjects (Ancillary Study)~   "
154943|NCT01538186|"~     This retrospective observational study included patients (pts) with percutaneous coronary~     intervention (PCI) of a de novo coronary bifurcation lesion in one German center between~     January 2008 - August 2011. The investigators included all consecutive patients where the~     side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.~      Two different methods were compared: group A represents patients with a simple strategy~     without any treatment of the side branch (SB). Group B consisted of patients where the SB was~     treated (PCI and/or stenting).~      For the treatment of bifurcation lesions we used the concept of provisional stenting,~     indications for the treatment of the SB were residual stenosis > 50 %, TIMI flow reduction <~     2. Final-kissing PCI was intended in all patients of group B.~      MACE during follow-up was evaluated in all patients.~   "
154947|NCT01538134|"~     The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed~     against cell membrane phospholipids (antiphospholipid antibodies) can cause an~     hypercoagulable state that causes thrombosis and obstetric complications (miscarriages,~     stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis~     includes the development of fetal growth restriction (diagnosed postpartum), but this was~     done without solid evidence of a relation between the two or using the most common form of~     fetal growth restriction diagnosis (ultrasound). Our study will try to add information to~     this particular point.~   "
154948|NCT01538121|"~     The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed~     against cell membrane phospholipids (antiphospholipid antibodies) can cause an~     hypercoagulable state that causes thrombosis and obstetric complications (miscarriages,~     stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis~     includes the development of severe preeclampsia before 34 weeks of gestation, but this was~     done without solid evidence of a relation between the two. Our study will try to add~     information to this particular point.~   "
154949|NCT01538108|"~     The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's~     percutaneous transluminal angioplasty (PTA) Balloon.~   "
154950|NCT01538095|"~     This phase I trial studies the side effects and best dose of trebananib in treating patients~     with solid tumors that has returned after a period of improvement or does not respond to~     treatment, including central nervous system tumors. Trebananib may stop the growth of tumor~     cells by blocking blood flow to the tumor.~   "
154951|NCT01538082|"~     The purpose of this study is determine the incidence of metabolic syndrome (MetS) in people~     of high risk, of 40 or more years and attended in the Primary Care. Evaluating the~     association between anxiety, depression, quality of life and the vital stressful events, and~     the development of the metabolic syndrome in general population.~      Our hypothesis is that population of the cohort with bigger degree of stress will develop~     earlier the metabolic syndrome.~      If our hypothesis about the metabolic syndrome are demonstrated, it would allow establishing~     in a future interventions on these factors of risk to prevent or to decrease the incidence of~     this syndrome in the Primary Care.~   "
154952|NCT01538069|"~     Introduction. Heart failure is the result of primary ventricular dysfunction followed by~     neurohormorais changes, distribution of cardiac output, peripheral circulation, the skeletal~     and respiratory muscles, which determine their clinical and prognosis. Despite the~     advancement in treatment, morbidity and mortality remain high. Physical training appears as a~     therapeutic strategy, because most of its beneficial effects is by inducing changes in~     peripheral physiological changes resulting from heart failure. Associated factors that may~     contribute to its progression and worse prognosis, now beginning to be studied, such as sleep~     apnea, the diagnosis provides important prognostic information and a potential therapeutic~     option for these patients.~      Objectives. Demonstrate the benefits of physical training for patients with heart failure and~     sleep apnea, and compare treatment with CPAP alone and associated with the exercise program.~     Will also be assessed risk and adherence to physical training.~      Material and Methods. The design will be prospective, longitudinal, randomized consecutive~     patients. After screening and baseline evaluations the patients will be randomized into Group~     1 (CPAP, n = 20), Group 2 (CPAP + Physical training, n = 20), Group 3 (Physical Training, n =~     20) and Group 4 (Control without intervention, n = 20). Outcomes (baseline and 3 months):~     Quality of sleep (polysomnography), Quality of life (Minnesota and SF-36), sexual function~     (QS-M and QS-F) and functional capacity (cardiopulmonary exercise testing and isokinetic~     testing). Physical training: aerobic and resistance exercises three times a week for three~     months. CPAP therapy:after polysomnography for titration with ventilator servo-assisted, and~     outpatient follow monthly, for three months.~   "
154953|NCT01538056|"~     The primary objectives of this study are to determine whether physician modified endovascular~     grafts are a safe and effective method of treating patients with elective, symptomatic or~     ruptured juxtarenal aortic aneurysms in those patients considered to be unsuitable candidates~     for open surgical repair and have no other options for treatment.~   "
154954|NCT01538043|"~     The aim of this study is to evaluate both cost/effectiveness- cost/utility and the possible~     mechanisms of action of spa therapy in patients with primary knee osteoarthritis (OA).~   "
154955|NCT01538030|"~     Premature rupture of membranes is an important cause of neonatal morbidity and mortality,~     mainly because of the complications associated with this pathology (oligohydramnios, cord~     compression or prolapse, infection). When rupture of the membranes occur the risk of cord~     compression increases but there is little evidence regarding this complication and amniotic~     fluid volume. The investigator's focus are the perinatal outcomes according to amniotic fluid~     volume (< 5 or >5).~   "
154956|NCT01538017|"~     Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's~     contracture affecting proximal interphalangeal joints. An open label, medico-independent~     randomized controlled trial.~   "
154957|NCT01538004|"~     The use of automated blood pressure measurement (ABPM) devices in the office setting is~     increasingly recognized as superior to manual BP measurement. Current guidelines recommend~     that patients be alone in a quiet room, with no interactions with health care professionals~     during the readings; in practice, this means using an exam room. However, we found no~     evidence supporting the location of ABPM. Furthermore, exam rooms are constantly being used~     in primary care offices, so this may not be practical in routine care.~      For this study, fifty consecutive consenting patients age 18 or more in each of seven~     community based primary care offices will randomly be allocated to either ABPM in an exam~     room, or in a non-private area of the clinic. After being tested in the first location they~     will then be tested in the second location with the same device. The main outcome will be the~     mean value of the last five systolic blood pressures for each location within offices.~     Secondary measures will include blood pressures for patients with or without hypertension, a~     comparison of the initial and second set of blood pressures and of the effect of office noise~     in decibels on BP readings.~      New technology is more readily adopted if barriers to use are minimized. If we find no~     differences in BP readings between office locations, clinicians will then have the option to~     use an additional office area to implement the automated BP measurement device.~   "
166731|NCT01383330|"~     The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(A) 625mg/5ml,~     Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed~     condition.~   "
154958|NCT01537991|"~     The I-START trial is designed to determine the highest doses of radiotherapy that can safely~     be used in locally advanced non-small cell lung cancer (NSCLC). Patients with NSCLC who are~     expected to live longer than three months and are fit to receive radical radiotherapy~     (radiotherapy given with curative intent) will be eligible to participate. All trial~     participants will receive 20 doses (called fractions) of radiotherapy. Evidence is available~     that suggests increasing the dose of radiotherapy given per fraction may improve both local~     control of the cancer and survival in some patients. However, high dose radiotherapy can~     damage normal tissues as well as the tumour. The dose of radiotherapy that can be used to~     treat lung cancer is limited by the normal tissues close to the cancer. For most of these~     normal tissues (lung, spinal cord and heart) the maximum safe radiotherapy dose that can be~     given is known. The maximum safe dose of radiotherapy for the oesophagus (gullet) is not~     currently known.~      The trial will be split into two parts:~        1. For those participants where the oesophagus will receive a high dose of radiation due to~          it lying close to the cancer, the first part of the trial will establish the maximum~          safe dose of radiotherapy to the oesophagus. The first group of participants will~          receive a slightly higher dose than is currently used to treat lung cancer. If these~          participants do not have any significant side effects, a second group of participants~          will receive a slightly higher dose than the first group. This process will continue~          incrementally until side effects from the treatment become evident, thus demonstrating~          the maximum dose that can safely be given. Once the maximum safe dose to the oesophagus~          is known this will be classed as the recommended Phase II dose and all further patients~          entering the trial will receive no more than this dose to the oesophagus.~        2. For those participants where the cancer is a safe distance from their oesophagus, the~          highest dose of radiotherapy that does not exceed the known safe dose limits of the~          normal structures (lung, spinal cord and heart) will be used.~      The findings of both parts of this study will determine whether increasing the dose of~     radiotherapy for NSCLC patients is a tolerable, safe and effective treatment. If the results~     are positive then this new treatment may be compared against the best currently available~     standard treatments in a future larger randomised (Phase III) trial.~   "
154959|NCT01537978|"~     The purpose of this study is to evaluate whether there are functional improvements in arm~     muscles and movments for spinal cord injured indviduals after performing video gaming.~   "
154960|NCT01537965|"~     The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now~     entering clinical practice. It is based on blood tests, especially FibroMetre® and Fibrotest®~     and on elastography with the Fibroscan®. Despite the overall satisfactory diagnostic~     performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on the study)~     for the discrimination of F≤1 versus F≥2, the positive and negative predictive values ,~     however, are far from be perfect in a given patient. With these technique, failures are also~     possible and the measures do not meet quality standards that increase the risk of~     misclassification. It would be particularly useful to have new generation techniques with a~     better diagnostic performance.~      In this project, in response to the problems presented above, we propose to evaluate the~     diagnostic performance of five innovative ultrasonic techniques for the non-invasive~     diagnosis of fibrosis.~   "
154961|NCT01537952|"~     Objective: Microbiologic etiologies of facial palsy in children were investigated.~      Study design: Prospective clinical study. Methods: Forty-six children aged 0-16 years with~     facial palsy comprised the study group. Paired serum samples and cerebrospinal fluid were~     tested to find indications (antibodies, growth of the microbe, or nucleic acids) of microbes~     putatively associated with facial palsy. The microbes tested were herpes simplex virus-1 and~     -2, varicella-zoster virus, human herpesvirus-6, Mycoplasma pneumoniae, Borrelia burgdorferi,~     influenza A and B-, picorna-, cytomegalo-, parainfluenza-, respiratory syncytial-, coxsackie~     B5-, adeno-, and enteroviruses, Chlamydia psittaci, and Toxoplasma gondii. Besides the~     routine tests in clinical practice, serum and cerebrospinal fluid samples were tested with a~     highly sensitive microarray assay for DNA of herpes simplex virus-1 and -2, human~     herpesvirus-6A , -6B, -7, Epstein-Barr-, cytomegalo-, and varicella-zoster viruses.~   "
154962|NCT01537939|"~     ASUKI Step is designed to increase the number of days employees walk 10,000 steps and to~     reduce the number of days employees spend being inactive.~      Study aims were:~        1. to have a minimum of 400 employee participants from each university site reach a level~          of 10, 000 steps per day on at least 100 days (3.5 months) during the trial period;~        2. to have 70% of the employee participants from each university site maintain two or fewer~          inactive days per week, defined as a level of less than 3,000 steps per day;~        3. to describe the socio-demographic, psychosocial, environmental and health-related~          determinants of success in the intervention; and~        4. to evaluate the effects of a pedometer-based walking intervention in a university~          setting on changes in self-perceived health and stress level, sleep patterns,~          anthropometric measures and fitness.~   "
154963|NCT01537926|"~     The purpose of the sudy is to conduct a small study to gather the preliminary data for future~     lage scale clinical studies that will be designed test the potential beneficial effect of~     over-the counter study anti-oxidant drug called N-acetylcysteine (NAC) in patients with a~     heart muscle condition called Hypertrophic Cardiomyopathy (HCM). The present study is a pilot~     feasibility study, the investigators want to find out whether the investigators can recruit~     and retain patients with HCM in the study and whether these patients can tolerate this drug~     and can stay on one year. Likewise, the investigators want to find out any potential side~     effects that this drug might have and estimate whether ii has any beneficial effects.~   "
154964|NCT01537913|"~     Hypothesis: FOUR score is a better predictor of outcome (in hospital mortality and functional~     outcome at discharge) than GCS in children 5- 18 years age admitted in pediatric ward/ ICU~     with non-traumatic impaired consciousness.~      The assessment of comatose patients is an important part of critical care. The assessment of~     the level of coma relies on clinical scores. The Glasgow Coma Scale (GCS),remains the most~     commonly used scoring system for altered state of consciousness. Despite its widespread use,~     a number of limitations have been identified with GCS like inability to assess verbal score~     in intubated patients and non-inclusion of vital brainstem functions. The FOUR (Full Outline~     of UnResponsiveness) score, a coma scale consisting of four components (eye response, motor~     response, brainstem reflexes, and respiration pattern) was recently proposed by investigators~     from the Mayo Clinic.keeping in view the limitations of GCS, this study was planned to~     compare the new FOUR score with GCS as a predictor of mortality and poor functional outcome~     at hospital discharge.~   "
154965|NCT01537900|"~     The goal of this study was to compare hepatic pharmacokinetics (PK) derived from liver tissue~     to plasma PK after administration of grazoprevir (MK-5172) to participants with chronic~     hepatitis C virus (HCV) infection. Participants will be randomized to one of four different~     liver ultrasound-guided Fine Needle Aspirate (FNA) schedules (at 4-, 8-, 24-, or 72-hours~     after the Day 7 dose).~   "
154966|NCT01537887|"~     The purpose of this study is to evaluate the effect on the electrical activity of the heart~     as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to~     10 days of placebo in relation to a single dose of moxifloxacin. Information about any side~     effects that occur will also be collected.~   "
154967|NCT01537874|"~     This study evaluates the effectiveness of a motivational interviewing intervention with~     families with young children ages 0-5 where smoking is happening in the home to adopt a~     smoke-free home plan and reduce child's second-hand smoke exposure.~   "
154968|NCT01537861|"~     Based on the pre-clinical data the investigators hypothesize that G-CSF treatment in patients~     with multiple myeloma will generate a 'hostile' bone marrow microenvironment for myeloma~     cells, depriving them of key support signals and rendering them more sensitive to~     chemotherapy. The investigators therefore propose to do an initial pilot study 1) to explore~     the safety of the combination of G-CSF and bortezomib-, carfilzomib-, or IMID-based treatment~     regimens in patients with bortezomib-, carfilzomib-, or IMID-refractory myeloma and 2) to~     generate correlative data for a subsequent larger study looking at the combination.~   "
154969|NCT01537848|"~     This is a retrospective study of a single center on endoscopic ultrasound (EUS) guided~     transmural drainage of post-operative collections during a 9 years period.~   "
154970|NCT01537835|"~     Healthcare worker uniforms are frequently contaminated with bacteria known to cause~     infections in humans. These bacteria are acquired during the workday. A new technology of~     antimicrobial textiles have been developed and incorporated into the fabric of health care~     worker uniforms, reportedly with effectiveness rates of > 99% but there is little literature~     describing the effectiveness of Healthcare worker (HCW) uniforms with antimicrobial~     properties in the clinical setting. Because of the potential benefit that such uniforms could~     offer HCWs and patients alike, further investigation into whether these fabrics are effective~     is warranted.~      Up to 140 physicians, nurses, and midlevel providers who work at Denver Health on the general~     internal medicine wards will be invited to participate in this study. Participants will be~     randomized to wear either uniforms (scrubs) that have antimicrobial properties or standard~     scrubs provided by the hospital. At the end of an 8-hour workday, three areas on each uniform~     and each subject's wrist area will be cultured to assess for total bacterial colonization as~     well as for various resistant bacteria such as methicillin-resistant Staphylococcus aureus~     (MRSA), vancomycin-resistant Enterococcus (VRE), and resistant gram-negative rods.~      Primary Hypothesis: HCW uniforms with antimicrobial properties will have less bacterial~     contamination than standard uniforms (scrubs) at the end of an 8-hour workday.~      Specific aim 1a. Demonstrate that antimicrobial uniforms will have less total bacterial~     contamination of sites swabbed compared to standard uniform after an 8-hour workday.~      Specific aim 1b. Demonstrate that antimicrobial uniforms will have less~     antimicrobial-resistant bacterial contamination (specifically looking for MRSA, VRE, and~     resistant gram negatives) of sites swabbed compared to standard uniform after an 8-hour~     workday.~   "
154971|NCT01537822|"~     Rationale:~      The hysteroscopic morcellator (HM) is a novel technique for removal of intrauterine polyps,~     myomas and placental tissue. It withholds some technical advantages over resectoscopy.~     Previous data suggest that it's a faster technique than the latter, and shows that it has a~     low complication rate.~      Objective:~      To compare the HM to bipolar resectoscopy for removal of:~      1) large intrauterine polyps, 2) smaller type 0 and 1 myomas, 3) residual placental tissue,~     in terms of efficiency and complications.~      Study design: Single blind, randomized controlled multicenter trial.~      Study population: Women aged over 18 years old with:~      1) large (≥ 1 cm) intrauterine polyps, 2) smaller (≤ 3 cm) type 0 or 1 myomas, 3) residual~     placental tissue, who are planned for hysteroscopic removal.~      Intervention:~      Patients are randomized between removal with the HM or the bipolar resectoscope.~      Main study parameters/endpoints:~      Installation and operating time.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      Women who are referred to our polyclinic will be seen on a first visit, and, according to the~     standard work-up, an ultrasound will be performed when intrauterine pathology is suspected.~     To confirm the diagnosis a saline infusion sonography (SIS) and/or ambulant diagnostic~     hysteroscopy will be performed consequently. Once the diagnosis is confirmed and surgery is~     planned, women will be asked whether they want to take part in this study. At this moment,~     both techniques are used in our hospitals and the choice of treatment depends on the~     preference of the gynaecologist. All women will be treated with operative hysteroscopy in a~     daycare setting according to the standard of care, only now randomized between the two~     techniques. A standard postoperative visit with ultrasound examination and/or ambulant~     diagnostic hysteroscopy is scheduled 6 weeks later. Late postoperative complications and~     complaints are recorded.~      It is expected that the HM beholds some advantages over the bipolar resectoscope such as~     shorter operating time and less complications (e.g. risk of perforation, current and fluid~     related complications). Previous data do not demonstrate any additional risks related to the~     use of the HM. Moreover we will check whether the HM has a lower risk of intrauterine~     adhesion formation, as this might influence patient's fertility.~      After completion of the RCT, an observational study is planned considering pregnancies~     subsequent to the hysteroscopic procedure.~   "
154972|NCT01537809|"~     The purpose of this research is to determine what supplemental doses of vitamin D may be~     necessary to raise serum levels to optimal levels and how vitamin D supplementation and~     changes in vitamin D status impact cardiovascular risk factors in schoolchildren.~   "
154973|NCT01537796|"~     The purpose of this study is to examine the effect of an enhanced technology-based system,~     that involves a wearable device to measure calories burned combined with a website, in~     comparison to previous versions of similar technology and a standard behavioral weight loss~     on body weight across 6 months in obese adults.~   "
154974|NCT01537783|"~     In this study, the investigators will enroll patients who present to the emergency department~     with abscesses to the study. The patients will be randomly selected to either have the~     standard of care, which includes the standard drainage of the abscess and then usually a~     follow-up visit to recheck the wound, or to have the standard of care plus instructions to~     use a topical scrub of a soap called chlorhexidine once a day for five days and twice daily~     application of a topical antibiotic ointment called mupirocin to the nasal passages for five~     days.~      The investigators will then call back the patients at 7 days, 14 days (if in the treatment~     arm), 3 months and 6 months, to ask if they have had any recurrence of abscess formation. The~     study hypothesis is that the patients who have undergone the decontamination protocol will~     have fewer subsequent infections.~   "
154975|NCT01537770|"~     The main purpose of this study:~      - to determine whether vertebroplasty has a pain palliating effect superior to a~     sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar~     spine.~      Secondary purposes:~        -  To determine if there are differences in the two methods on preventing forward tilting~          of the spine and/or shortening of the total height of the spine.~        -  measure if there are differences in change of lung capacity between the two methods~   "
154976|NCT01537757|"~     This study will assess the pharmacokinetics of MK-8931, a ß-secretase inhibitor, in~     participants with renal insufficiency. In Part 1 of the study, pharmacokinetics of MK-8931 in~     participants with severe renal disease and in healthy matched control participants will be~     studied. If data from Part 1 confirms that severe renal impairment does not alter the~     pharmacokinetics of MK-8931 to the extent requiring dosage adjustment, then no further study~     will be required and Part 2 will be optional. If the data does not support this conclusion,~     then Part 2 will be conducted to study the pharmacokinetics of MK-8931 in participants with~     moderate and mild renal impairment compared to healthy matched controls.~   "
154977|NCT01537744|"~     The purpose of this study is to determine whether 5-azacitidine in combination with~     romidepsin cancer are effective in the treatment of advanced solid tumors.~   "
154978|NCT01537731|"~     Previous studies have shown that chronic pain after hysterectomy is common. The aim of this~     study is to investigate the incidence of chronic pain after vaginal or laparoscopic~     hysterectomy for benign reasons. The aim of this prospective study is also to study the role~     of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.~   "
154979|NCT01537718|"~     The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized,~     longitudinal study.~   "
166829|NCT01382056|"~     Consumption of a diet containing pulse crops provides flavonoid compounds that will improve~     vascular function and glycemic control in individuals with Peripheral Artery Disease.~   "
154984|NCT01537653|"~     Primary Objective:~      Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous~     (SC) doses in healthy Japanese adult male subjects~      Secondary Objectives:~      Assess the following parameters after ascending single SC doses in healthy Japanese adult~     male subjects~        -  The pharmacokinetics of SAR231893 (REGN668)~        -  The immunogenicity of SAR231893 (REGN668)~        -  Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)~   "
154985|NCT01537640|"~     Primary Objective:~      To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668)~     drug products after administration of a single subcutaneous (SC) dose~      Secondary Objective:~      To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug~     products after administration of a single SC dose~   "
154986|NCT01537627|"~     Several impairing factors contribute to physical limitation in chronic obstructive pulmonary~     disease (COPD) as deconditioning, muscle dysfunction and physical inactivity. The available~     literature clearly indicates that these therapeutic targets benefit from exercise training in~     patients with COPD and, currently, the key point is not whether patients should or not~     exercise, but which is the specific contribution of each exercise modality to this~     population. About this topic, the characteristics of a physical training program to be~     offered to patients have been a point discussed among researchers in this field, although~     recently the high-intensity training has been recognized as superior in comparison to the~     low-intensity training. Literature also indicates that, in order to change the sedentary~     lifestyle of patients with COPD, long-term training programs are indicated. However, a doubt~     still remains: if long-term programs are one of the key points to reduce physical inactivity,~     it is not yet clear whether it is necessary to include high-intensity exercises in that~     long-term program. If the duration is the only factor influencing the outcomes of the~     program, thus the intensity of training could be reduced, increasing the adherence of~     patients to the protocol. Based on this hypothesis, the aim of this study is to compare the~     effects of two physical training protocols in a long-term rehabilitation program (6 months)~     in patients with COPD: a high-intensity protocol (based on endurance and resistive training)~     and a low-intensity protocol (based on callisthenic and breathing exercises training). It is~     expected that the results of this study contribute to the scientific literature by~     demonstrating whether low- and high-intensity training contribute equally to change the~     sedentary lifestyle of patients after a long-term exercise program.~   "
154987|NCT01537614|"~     Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI~     colimycin either as an aerosol or after IV injection, the administration being separated by 5~     to 10 days intervals~   "
154988|NCT01537601|"~     Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary tract~     infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs in~     healthy children. The effect of circumcision on the number of UTIs in boys with PUV has not~     yet been studied. Through a prospective randomised trial of children with posterior urethral~     valves the investigators wish to determine the effect of circumcision on the risk of~     presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other will~     be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. Both~     groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24~     months. A DMSA scan will be performed at 1-2 and 24 months and biological renal function will~     also be monitored. The relative risk of presenting a febrile UTI in each group will be~     determined. Clinical, radiological and antenatal data concerning each child will be analysed.~     At 24 months follow-up, an impact on family scale survey (IOFS) will be proposed parents.~   "
154989|NCT01537588|"~     The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and~     apply that knowledge to the treatment and management of patients who undergo anterior~     cruciate ligament (ACL) reconstruction. There are three main components of this study:~        1. How do muscle shape, size, strength, and ability to function change following hamstring~          grafting for ACL reconstruction;~        2. How does physical activity change following ACL reconstruction;~        3. Is there a difference in outcome if graft harvest is done from the injured versus~          uninjured limbs~   "
154990|NCT01537575|"~     Postpolio syndrome is a condition that affects many polio survivors years after the acute~     infection and causes symptoms to increase or new symptoms to develop. Proinflammatory~     cytokine production within the central nervous system (CNS) indicates an underlying~     inflammatory process, amenable to immunomodulatory therapy. In this study the investigators~     sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves~     the disease.~   "
154991|NCT01537562|"~     Today a large proportion of early abortions are medical, in accordance to the woman's choice.~     The main objective of the present study was to compare, in a randomised fashion, initiation~     of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post medical abortion~     with regard to expulsions and safety.~   "
154992|NCT01537549|"~     Studies have shown that alpha-lipoic acid and L-acetyl carnitine may have some~     neuroprotective activities and it is hoped that they could be helpful for people with~     neurodegenerative illnesses such as progressive supranuclear palsy (PSP).~      The purpose of this study is to find out whether the nutritional supplement alpha-lipoic~     acid/L-acetyl carnitine is safe and well-tolerated in individuals with PSP when given daily,~     and whether it affects their well-being, brain scan measurements and blood tests that measure~     the energy metabolism in cells.~   "
154993|NCT01537536|"~     The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as~     measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of~     weekly paclitaxel. This is a prospective single-center study that will investigate the~     activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast~     cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant~     chemotherapy).~   "
154994|NCT01537523|"~     The early community-care program is well-known rehabiliation for the fracture hip patient.~     For the discharged fracture hip patient from hospital, it is worth to investigate the effect~     of early mobilization program to improve their physical and psychological aspects.~   "
154995|NCT01537510|"~     Childhood obesity is highly prevalent and is associated with both short- and long-term~     adverse outcomes.~      Despite availability of guidelines for nearly a decade and more recent comparative~     effectiveness research (CER) evidence, the health care system has been slow to adopt~     recommended practices. Although pediatric health care providers often cite barriers such as~     limited time, skill, and resources, a frequently overlooked barrier is the lack of data~     systems to efficiently and accurately assess guideline implementation and to improve quality~     of care for childhood obesity. Health information technology (HIT) offers potential for~     accelerating the adoption of CER evidence regarding childhood obesity screening and~     management, for establishing treatment benchmarks, and for supporting patients and their~     clinical teams in care improvement. Incorporation of HIT may be especially effective if~     augmented by outreach to parents and children.~      The goal of this study is to develop and test system-level interventions to accelerate the~     adoption of CER evidence on childhood obesity screening and management, and ultimately~     improve obesity-related health care quality and outcomes. To achieve this goal, the~     investigators will work with two health care systems in Massachusetts with strong track~     records of research collaboration: Cambridge Health Alliance (CHA), an integrated academic~     public health system, and Harvard Vanguard Medical Associates (HVMA), a large multi-site~     group practice. Both systems use an electronic medical record for all aspects of ambulatory~     care, including point of care services such as electronic order entry and centralized~     functions such as patient scheduling.~      In these settings of innovation and commitment to improving quality of care, the~     investigators will develop and test two systematic strategies for adoption of CER evidence.~     The first incorporates computerized point of care decision alerts to pediatric primary care~     providers during routine office visits, linked to CER-based algorithms of care. The second~     augments this HIT approach with direct-to-parent communication of child's body mass index~     (BMI) along with recommended evaluation and management. The specific aims of this study are:~        1. In 18 community health centers of CHA, to identify barriers to and facilitators of~          adoption of an existing set of computerized point of care decision alerts for childhood~          obesity screening and management. The investigators will achieve this aim through~          in-depth interviews and surveys with primary care clinicians, which will inform the~          design of the investigators proposed intervention.~        2. In 14 practices of HVMA, to conduct a cluster-randomized controlled trial to examine the~          extent to which computerized point of care decision alerts to pediatric primary care~          providers, with or without direct-to-parent communications, will increase adoption of~          CER evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th~          percentile. The investigators will determine the extent to which each of the 2~          intervention conditions, compared with the usual care control condition and with each~          other, results in:~             1. Increased screening and assessment of childhood obesity at the point of care,~               including BMI, blood pressure, and laboratory screening, and provision of nutrition~               and physical activity counseling,~             2. A smaller age-associated increase in BMI over a 1-year period, and,~             3. Improved specific dietary, physical activity, and sedentary behaviors over a 1-year~               period.~        3. To evaluate each intervention's costs (including clinician and family time) and~          cost-effectiveness in terms of children's change in BMI and weight-related behaviors.~        4. To develop a detailed dissemination guide to further accelerate adoption of CER evidence~          on childhood obesity in practices and communities interested in implementing similar~          interventions.~      To achieve the investigators aims, the investigators have assembled a research team with~     extensive experience in obesity prevention, clinician and child behavior change, clinical~     informatics, statistical methodology in cluster randomized controlled trials,~     cost-effectiveness analyses, and dissemination science. If successful, this project will~     provide new and sustainable approaches for accelerating adoption of CER evidence for~     childhood obesity screening and management and for improving quality of care for childhood~     obesity in pediatric primary care.~   "
154996|NCT01537497|"~     The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of~     PF-05175157 in a dose-dependent fashion in healthy volunteers~   "
154997|NCT01537484|"~     The purpose of this study is to verify the efficacy of an 8-week course of manualized Swedish~     massage for reducing pain and increasing function compared to light-touch bodywork, and usual~     care, in 222 adults with OA of the knee.~   "
154998|NCT01537471|"~     The purpose of the investigators research is to test whether problems people have with~     processing their senses (feeling overwhelmed, distracted or upset by sounds and other~     stimuli) can be lessened by meclizine, a drug found in many over the counter antihistamines,~     which are medicines used for things like allergies, sleep problems, or the common cold.~   "
154999|NCT01537458|"~     Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is~     known to cause significant morbidity and mortality, no good guidelines are available to guide~     intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral~     valve repair. Treatment options for isolated repair have not been investigated thoroughly.~      The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve~     repair, performed in our center. By doing this, the investigators want to evaluate predictors~     of outcome after repair.~   "
155000|NCT01537445|"~     The purpose of this study is to evaluate the beneficial effect of pancreas transplantation~     for long term kidney function in patients undergoing single-pancreas transplantation.~   "
155001|NCT01537432|"~     This study is designed to evaluate the proportion of patients achieving reversal of chronic~     plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered~     subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive~     multiple doses of secukinumab up to week 52 to study long term effects of secukinumab.~     Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to~     better understand, why secukinumab may be effective in psoriasis patients.~   "
155002|NCT01537419|"~     This study will evaluate the efficacy of attachment based family therapy (ABFT) for treatment~     of suicidality in adolescents. The study will compare 16 weeks of treatment with ABFT to a~     control condition Family Enhanced Non-directive Supportive Therapy (FE-NST).~   "
155003|NCT01537406|"~     The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years~     after the delivery of the radiation treatment, and to compare the frequency between subjects~     that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received~     standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast~     compared to the non-treated breast, will be assessed. Also, the occurrence of delayed~     radiation treatment side effects including tiny red vessels in the skin, breast indurations~     (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin~     dryness will be captured.~   "
155004|NCT01537393|"~     The purpose of this study is to determine if the 3-year graft failure rate following~     endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14~     days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or~     fewer days are used.~   "
155005|NCT01537380|"~     With 6.5 million obese recorded in France in 2009, obesity is a major public health: it is a~     chronic disease associated with many respiratory, cardiac, metabolic, musculoskeletal~     complications. The risk of mortality and morbidity are directly proportional to the~     importance of overweight and medical treatment alone is only moderately effective weight~     loss. Bariatric surgery is the only treatment with proven efficacy in patients with a body~     mass index above 40 kg/m2. As with any surgery, there is a risk of surgical site infection~     (SSI). The SSI are the third most common nosocomial infection after urinary tract infections~     and airway. The fight against the ISO requires the administration of antibiotic prophylaxis~     acting on the main bacteria found in bariatric surgery. There are several studies in the~     literature interested in the dose of cefazolin in bariatric surgery. However, no published~     pharmacokinetic studies defines an optimal dose to obtain tissue and plasmatic concentrations~     of cefazolin higher than minimum inhibitory concentrations of the main germs encountered in~     these surgery. Only empirical recommendations are published, including the SFAR and the~     National Institute of Health in 2010. This study aims to determine whether the dose of 4~     grams of cefazolin can achieve these goals of concentration and estimate an injection time of~     preoperative ideal for an adequate tissue concentration at the time of the incision.~   "
155006|NCT01537367|"~     PROJECT OVERVIEW~      This research is a collaboration between the Centers for Disease Control and Prevention~     (CDC), the Health Resources and Services Administration (HRSA), and six university-affiliated~     HIV clinics in the United States.~      Study title: Intervention Trials to Retain HIV Patients in Medical Care~      Study sites: The study will be performed at six HIV clinics affiliated with academic medical~     centers.~      Objectives: Using HIV patients' clinical data (without personal identifiers) routinely~     archived in electronic databases at the six participating clinics do the following:~      • To examine the extent to which a client-centered intervention delivered by trained~     interventionists (Phase 2 trial of the project) improves patient attendance for HIV primary~     care over and above the effect of the clinic-wide intervention. Phase 2 is a three-arm~     randomized controlled trial conducted at each of the participating six clinics. 300 patients~     will be enrolled in the Phase 2 trial at each clinic. One hundred will be new patients and~     200 will be patients with inconsistent attendance for HIV primary care at the clinic in the~     prior 12 months. Patients will be randomized to: (1) an enhanced contact plus behavioral~     skills arm or (2) an enhanced contact-only arm in which patients will receive a longer or a~     shorter client-centered intervention from two trained interventionists, or (3) the standard~     of care arm in which patients will receive the clinic-wide intervention and routine HIV~     clinical care only.~   "
155007|NCT01537354|"~     This is a null hypothesis study. The investigators hypothesize that there will be no~     difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute~     intervals after administration of either surfactant and there will be no differences in the~     number of doses needed between the two surfactants in premature infants admitted to our NICU.~   "
155008|NCT01537341|"~     Innovative advances in rehabilitation technology have created a split-belt treadmill capable~     of providing a much needed intervention aimed at limiting mobility disability. When~     desynchronized, the split-belt treadmill imposes demands on each leg such that the central~     nervous system must adapt to the challenge. Based on preliminary data from our lab utilizing~     the split-belt treadmill, the investigators hypothesize this intervention can challenge the~     locomotor processes required for safe, efficient gait while concurrently providing an aerobic~     stimulus will produce favorable changes in physical function in older adults at risk for~     mobility disability.~   "
155021|NCT01537172|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-4053~     across ascending single and multiple doses in healthy adult male and female subjects.~      The secondary objective of the study is to characterize the pharmacokinetic profile of~     ONO-4053 in healthy adult male and female subjects.~   "
167112|NCT01378351|"~     The purpose of this study is to characterize the accompanying symptoms, evaluation and~     management of patients with chronic vestibular dysfunction presenting with nausea and~     vomiting.~   "
155009|NCT01537328|"~     The purpose of this study is to evaluate the effectiveness of a progressive resistance~     rehabilitation program (PROG) after total knee arthroplasty (TKA) compared to a traditional~     rehabilitation program (TRAD).~      The investigators hypothesized:~        -  PROG will result in greater improvements in functional outcome measures such as: stair~          climbing test (SCT), timed-up-and-go test (TUG), six minute walk test (6MW), the Knee~          Injury and Osteoarthritis Outcome Survey (WOMAC), and knee range of motion (ROM).~        -  PROG will result in greater improvements in quadriceps muscle strength gains after TKA~          compared to TRAD.~        -  PROG will result in greater improvements in muscle mass and central activation compared~          to TRAD.~   "
155010|NCT01537315|"~     Presence of multiple traditional and nontraditional risk factors of atherosclerosis and~     cardiovascular disease (CVD) including inflammation in patients with chronic kidney disease~     (CKD) contribute to high CVD morbidity and mortality in this patient population.~     Additionally, the traditional approaches towards the therapy of CVD have little impact on CV~     mortality in these patients. Hydroxychloroquine (HCQ) used as anti-inflammatory in~     rheumatological disorders, has multiple beneficial properties relevant to the process of~     vascular disease. The effects of HCQ on atherosclerosis (AS) and vascular disease in CKD is~     not known yet. Thus, the study hypothesis is that HCQ treatment in individuals with CKD will~     provide clinically significant benefit in the management of CVD and will provide biological~     and functional atherosclerotic benefits.~   "
155011|NCT01537302|"~     Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted~     orientation while simultaneously crossing totally occluded femoropopliteal arteries.~   "
155012|NCT01537289|"~     A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with~     traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.~      There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site~     pain is less than CT.~   "
155013|NCT01537276|"~     As an essential step of the infertile work-up, hysterosalpingogram (HSG) has some advantages~     including the lack of need for anesthesia, a non-invasive procedure with less cost and~     relative easy to put into practice. However, it would be failed to detect the extra-tubal and~     peritoneal pathology and would be also difficult to distinguish the obstruction caused by the~     spasm of intramural segment. Obviously, imaging quality plays a key role in diagnostic~     accuracy of the HSG, studies had taken four roentgenograms and combined with the fluoroscopy~     were reported a higher sensitivity and specificity than those only taken two images in the~     examination. And hybridized radiography with CT or MRI system may provide the good-quality of~     the HSG. It is also reported that the sonosalpingography (SSG), which detect the tubal~     patency in real time, can show pelvic pathologies better than HSG. However, no parallel study~     was designed to verify the hypothesis that combined the fluoroscopy and taken more images can~     improving the diagnostic quality of the HSG. The aim of this study is to evaluate whether the~     accuracy of HSG can be improved by real-time evaluating under the fluoroscopy.~   "
155014|NCT01537263|"~     The purpose of this study is to examine wether delayed cerebral ischemia can be predicted by~     ultrasound brain perfusion imaging in patients with aneurysmal subarachnoid hemorrhage (SAH).~   "
155015|NCT01537250|"~     The purpose of this study is to evaluate the safety, tolerability and population~     pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.~   "
155016|NCT01537237|"~     The purpose of this study is to compare rotational angiography (3DATG~     technology)intra-procedure (during the ablation procedure) with CT (x-ray) pre-procedure~     (before the ablation procedure) fusion to create an anatomical picture of a heart to help~     adequately guide an ablation procedure for patients with arrhythmias.~   "
155017|NCT01537224|"~     The role of the basal ganglia in the processing of information with emotional or motivational~     content has been demonstrated by several lesion and functional imaging studies in humans and~     animals. Deep brain stimulation surgery provides an opportunity to study these structures in~     humans in electrophysiological terms. The aim of this study is to investigate modifications~     in the electrophysiological activity of the subthalamic nucleus (STN) during the perception~     of auditory and visual stimuli with emotional or motivational connotations in patients with~     Parkinson's disease who have just undergone implantation of a deep brain stimulator in the~     STN.~   "
155018|NCT01537211|"~     In older adults, poor circulation in the lower extremities leads to serious health~     complications including limb loss. In addition, individuals with dysvascular disease also~     suffer from other co-morbidities like diabetes, coronary and cerebrovascular disease. An~     individual with a transfemoral (TF) amputation is usually fitted with a prosthetic limb to~     assist with function, including a prosthetic knee and a prosthetic foot. Currently,~     dysvascular amputees are given a prosthetic knee based on the basic expectation that they~     will be functionally stable. This consideration does not address higher levels of function~     like walking at multiple speeds and over uneven ground. Also, dysvascular amputees are not~     able to counteract their co-morbidities with a more active lifestyle. Walking is less energy~     efficient; their traditional prostheses may cause early onset of fatigue and induce a fear of~     falling. Newer microprocessor knees enable patients with transfemoral amputations to walk on~     different surfaces and at multiple cadences through better control in swing and stance phases~     of gait. The impact of the functional differences in the prostheses is not clear and requires~     additional investigation to clarify the choice of the most appropriate functional prosthesis.~     The purpose of this study is to compare the functional outcomes with the traditional~     mechanical knee versus the microprocessor knee (C-leg) in transfemoral amputees.~   "
155019|NCT01537198|"~     Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual~     practice according to the approved Korean product label will be registered into this~     observational study. Baseline data will be obtained at enrollment including demographics,~     gestational age, birth weight and underlying diseases and complications especially in regard~     to respiratory disease and cardiovascular disease. At routine visits for Synagis~     administration, which will occur according to usual medical practice, information on Synagis~     prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days~     after the last administration of Synagis.~   "
155020|NCT01537185|"~     The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine~     (SPWCV) given with alum is safe and well tolerated by healthy adults.~   "
167113|NCT01378338|"~     Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD~     in Korea-an observational study.~   "
155022|NCT01537159|"~     The purpose of this study is to investigate if a type of magnetic resonance imaging (MRI)~     scan of the bone marrow before the start of standard chemotherapy can predict complete~     remission of leukemia patients after the therapy. This type of MRI scan, called dynamic~     contrast-enhanced MRI (DCE-MRI), measures bone marrow blood flow. For those patients who do~     not achieve complete remission status after initial therapy and will be treated with~     additional therapy, the investigators are also interested in determining if the second MRI~     exam before the additional therapy can predict complete remission. If successfully tested,~     the MRI exam may be used in the future to help with early identification of patients who are~     unlikely to respond to standard chemotherapy. This will allow for a personalized therapeutic~     plan to be developed for these patients at an early stage and prevent them from being exposed~     to toxic and ineffective therapies.~   "
155023|NCT01537146|"~     The purpose of this study is to elucidate whether patients operated with high tibia~     open-wedge osteotomy for osteoarthritis of the knee can be treated more appropriately, so~     that both healing and rehabilitation are served optimally.~   "
155024|NCT01537133|"~     There are new, very sensitive methods for detecting bacteria. These methods show that~     hundreds of millions of microbes (organisms that can only be seen with microscopes),~     especially bacteria, live in healthy people. The collection of different microbes found in a~     site is called a microbiome. The investigators know that microbiomes of the skin, sinuses,~     mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome -~     which bacteria are found in a site - may be necessary for good health. For example, the~     microbiome of the mouth is different in people with inflammation of the gums (periodontitis),~     and the microbiome of the bowel is different in people with inflammation of the intestinal~     tract (inflammatory bowel disease).~      The purpose of this research study is to find out if the microbiome in the lungs is different~     in healthy people without asthma compared to people with asthma. This study will also find~     out if the microbiome of the lungs changes when people with asthma take a daily controller~     medication called an inhaled corticosteroid.~   "
155025|NCT01537120|"~     This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool~     for the evaluation of both new and existing pharmacological treatments for type 2 diabetes,~     using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a~     probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin,~     twice daily will lead to a statistically significant decrease in 24 hour weighted-mean~     glucose (WMG) relative to placebo.~   "
155026|NCT01537107|"~     This phase I trial studies the side effects and the best dose of sirolimus when given~     together with vismodegib in treating patients with solid tumors or pancreatic cancer that is~     metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth~   "
155027|NCT01537094|"~     Obesity is associated with reduced growth hormone (GH) secretion. GH secretion is regulated~     by nutritional stimuli including fasting, insulin, glucose and free fatty acids. However, the~     role of micronutrients, such as vitamins, on GH secretion has not been investigated in much~     detail. Vitamin C levels are also reduced in obesity, and the investigators recently~     demonstrated a possible role for dietary vitamin C intake in the regulation of GH secretion~     in two preliminary retrospective studies. The investigators therefore propose a more detailed~     prospective physiological study to examine the effects of increasing dietary vitamin C intake~     on GH secretion in a physiologic, intervention study. The investigators hypothesize that~     increasing vitamin C concentrations in obese subjects with sub-optimal plasma vitamin C~     levels and reduced GH secretion will increase GH secretion.~   "
155028|NCT01537081|"~     The study is designed to meet regulatory requirement outside the US. The dosing regimen and~     assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not~     match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether~     Mucinex is effective and non-inferior as compared to placebo and immediate release~     guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design~     was required based on EU regulatory guidance.~   "
155029|NCT01537068|"~     The investigators are studying a new antidepressant medicine, desvenlafaxine, for the~     treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been~     approved by the FDA for the treatment of major depression.~      The investigators are testing whether this medicine is also effective for adults with a type~     of chronic depression that is less severe than major depression. This condition is also known~     as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years, often~     causes significant suffering and impairment.~      In addition, the investigators are using MRI imaging, which uses magnetic signals to make~     pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in~     this study is to see whether chronic depression is associated with differences in brain~     structure or functioning, and whether such differences change after medication or placebo~     treatment. To test this MRI scans are done at the start of the study and after 12 weeks of~     medication or placebo treatment. Getting MRI imaging will be an option for participants in~     this study but is not required.~      This study involves a 6 to 12 week double-blind period during which half of the participants~     will take the new medication and half will take a placebo (an inactive look-alike pill).~     After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved~     antidepressant medication.~      Assessments (of depressive symptoms, social functioning, and personality) will be done by~     study staff and by patients before the study starts, at each study visit for the first 12~     weeks, and again after 24 weeks in the study.~   "
155030|NCT01537055|"~     To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple~     therapy in the second line therapy for those who fail from one eradication therapy~   "
155031|NCT01537042|"~     This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in~     subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.~      The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to~     investigate the effect of Rotigotine on quality of life and sleep.~   "
155048|NCT01536821|"~     The PROGENI Family Study is part of a larger consortium that is studying a gene shown to be~     important in Parkinson's disease, called LRRK2. People who have a defect in the LRRK2 gene~     will often develop Parkinson's disease. Eligible participants will be asked to complete a~     single Study Visit at an affiliated research facility closest to their home.~   "
155032|NCT01537029|"~     To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in~     participants who are normal weight (body mass index [BMI] < 25 kg/m2, overweight or class I~     obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that~     participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than~     participants who weigh less. Restated, the area under the drug-concentration time profile,~     also known as the AUC, in participants will decrease as participant weight increases.~   "
155033|NCT01537016|"~     The purpose of this trial is to determine if wounds with elevated protease activity (EPA)~     treated with targeted interventions such as protease modulating therapies can improve~     clinical and economic outcomes.~      It is hypothesized that protease modulating dressings may provide significantly better~     clinical outcomes on EPA wounds over current standard of care.~   "
155034|NCT01537003|"~     The purpose of this trial is to determine if wounds with elevated protease activity (EPA)~     treated with targeted interventions such as protease modulating therapies can improve~     clinical and economic outcomes.~      Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds~   "
155035|NCT01536990|"~     The purpose of this study was to investigate the reliability, construct validity, and~     sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected~     by stroke.~   "
155036|NCT01536977|"~     This pilot clinical trial studies early brief behavioral intervention in treating sleep~     disturbance and improving quality of life in patients undergoing bone marrow transplant~     (BMT). A brief behavioral intervention may reduce symptoms of insomnia and fatigue and~     improve quality of life and cognitive function in patients undergoing BMT~   "
155037|NCT01536964|"~     Heart Attacks are a major cause of death in this country. When patients have a heart attack,~     they are treated with anti-clotting drugs, one of which is a drug called Prasugrel. It is~     important that Prasugrel starts to work as quickly as possible following a heart attack. As~     many patients who have a heart attack experience excruciating pain, they are often given~     morphine (a strong painkiller) by the Ambulance crew. We think that morphine may affect how~     Prasugrel is absorbed from the stomach and may delay how quickly it starts to work. We intend~     to study the effect of morphine on the absorption of Prasugrel.~   "
155038|NCT01536951|"~     This will be a 2-part, randomized, participant- and investigator-blind study in healthy males~     and females.~      Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that~     yields drug exposures slightly exceeding typical exposures anticipated from repeated~     administration of an efficacious dose to participants. The concentration of the drug in the~     blood stream will be measured and information about any side effects that may occur will also~     be collected.~      Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the~     heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral~     dose.~   "
155039|NCT01536938|"~     The purpose of this study is to investigate whether LEO 90100, calcipotriol and betamethasone~     are effective in the treatment of psoriasis vulgaris.~   "
155040|NCT01536925|"~     This research deals with behaviors that are part of opioid dependence. The purpose is to~     study the extent to which stress and other factors, including money and amount of work~     effort, affect opioid choice. Specifically, the investigators will examine the effects of~     three issues/factors. The first is how hard participants are willing to work to obtain an~     opioid drug; the second is how much opioid drug would participants choose instead of money;~     and the third factor is how much participant's opioid drug choices are influenced after they~     are administered the drugs yohimbine and hydrocortisone, both of which could produce~     stress-like symptoms.~   "
155041|NCT01536912|"~     More scientific information is needed about medical marijuana use among HIV positive~     patients. There is conflicting information about the use of marijuana, use of medical~     marijuana, and the associations between them and health status/health risk behaviors/health~     care utilization. In addition, it is not clear whether patients who participate in~     prospective clinical studies differ from participants who do not participate; if there are~     differences between those two groups, then this would limit generalizability of knowledge~     about these issues.~      The goal of this project is to describe the use of marijuana among HIV positive patients and~     its association with health status/health risk behaviors/health care utilization.~   "
155042|NCT01536899|"~     The investigators are interested in understanding personal factors such as medical conditions~     and mental health, as well as social and economic factors, that influence marijuana (and~     other substance) use in HIV-positive patients.~      Several alternative hypotheses will be evaluated in the proposed project:~        1. healthier patients may self-select marijuana use;~        2. marijuana use may be associated with consequences that create barriers to seeking~          healthcare;~        3. marijuana use may have medicinal value that reduces the need for such care.~   "
155043|NCT01536886|"~     The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus~     betamethasone are effective in the treatment of psoriasis vulgaris.~   "
155044|NCT01536873|"~     ING114916 is an open-label, multi-center, expanded access (EAP) study~   "
155045|NCT01536860|"~     The purpose of this study is to assess whether added food ingredient(s) affect glycemic~     responses to a liquid meal tolerance test (LMTT).~   "
155046|NCT01536847|"~     The purpose of this study is to assess whether added food ingredient(s) affect glycemic~     responses to a liquid meal tolerance test (LMTT).~   "
155047|NCT01536834|"~     This is a non comparative pre-CE marking pilot clinical investigation is required to evaluate~     the safety and performance in intended use of the Verruca treatment - NPD396, Class IIa~     medical device for verrucas in the adult population. The treatment regime will be topical~     application of the Verruca treatment to the verruca, identified as the reference, once daily~     for 4 weeks.~      Patient & investigator derived outcomes will also be collected to assess clinical performance~     and adverse events and adverse device effects will be reported to assess safety profile.~      Patient assessments will take place pre-treatment to determine patient demography, baseline~     clinical status, pain and verruca size prior to treatment. Compliance with treatment schedule~     will be collected via patient diary cards. Furthermore, patients will be assessed on day 2~     after starting treatment and then again at 7, 14, 21 & 28 days after starting treatment.~     Diary cards will completed through-out the investigation.~   "
155049|NCT01536808|"~     The potential clinical implications of this study are to optimise the selection of a~     population at risk for developing a diabetic cardiomyopathy among diabetic patients in order~     to develop early therapeutic strategies to prevent the left ventricular remodelling.~      Therefore, the originality of this project is to hypothesize that :~        -  Diabetes mellitus is often associated with a premature aging syndrome~        -  Cellular senescence may potentiate the mechanisms that are involved in decreasing~          myocardial contractility in DM and,~        -  DM associated to premature aging may increase the risk of developing a cardiomyopathy~          Thus, the modulation of telomerase activity and the control of telomere length, together~          with the attenuation of the formation of reactive oxygen species, might represent~          important new targets in order to develop therapeutic tools in prevention of diabetic~          cardiomyopathy.~   "
155050|NCT01536795|"~     This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing)~     is more effective than WR279396 without occlusion for once daily treatment.~      Extensive objective and subjective local tolerance data will also be captured during this~     trial, as well as surrogate markers (parasite loads and aminoglycosides concentration in the~     deep dermis) that may help to determine the optimal number and duration of treatments.~      The results from this study will help determine the most practical treatment schedule and~     will answer questions that are crucial to improve the present treatment regimen with WR279396~     which is twice a day for 20 days.~   "
155051|NCT01536782|"~     The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or~     pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated~     calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck~     undergoing chemoradiation therapy.~   "
155052|NCT01536769|"~     The cause of Parkinson's disease (PD) is unknown and a reliable biomarker to identify PD~     patients as early as possible is urgently needed. Nerve cells near the nose and in the gut~     become first affected in PD and patients frequently suffer from loss of smell and~     constipation. The nose and gut harbor very high amounts of bacteria that influence our body~     functions in many ways, even in the brain. The investigators are examining a possible role of~     bacteria of the nose and gut in the pathogenesis of PD. This may lead to a better~     understanding of what PD causes and may open new possibilities for diagnosis and treatment.~      The investigators will recruit 100 PD patients and 100 control subjects. The investigators~     will characterize all subjects carefully with respect to clinical symptoms. The investigators~     will collect bacterial samples from the nose, mouth and stool of these subjects. Using modern~     genomic techniques the investigators will read out the genetic code of all bacteria contained~     in these samples and will be able to identify which species of bacteria are present in the~     samples. Using complex cluster computing the investigators will compare the pattern of~     bacterial species between PD patients and controls and look for specific abnormalities in PD~     patients.~      If the investigators can detect specific differences of bacterial communities between PD~     patients and controls this may point to a role of bacteria as a cause of PD. Since there are~     many ways to influence bacterial communities pharmacologically (antibiotics, probiotics) it~     will be possible to investigate whether these therapies could alleviate or even reverse PD~     symptoms. Furthermore, the investigators would be able to use these differences as a~     biomarker which would enable us to develop a quick screening test for bacterial samples that~     may reveal whether a person has PD or not.~      By doing this study the investigators will learn whether bacteria play a role in the~     development of PD and whether the investigators can use them as a biomarker or therapeutic~     target. So hopefully the investigators will be able in the future to better understand what~     causes PD, how the investigators can diagnose it as early as possible and how to cure~     patients from PD.~   "
155053|NCT01536756|"~     Evidence shows that depression was found to be associated with physical inactivity and on the~     other hand, high prevalence of depression was also found in patients with chronic pain.~     Structured physical rehabilitation program with exercises as main component and pain~     management provided by physiotherapy has been proved by overseas studies to be effective in~     reducing the psychological symptoms of depression through increasing the physical fitness and~     relieving the pain. Literatures also reported a strong sociocultural influence on the~     prevalence of depression and the manifestations of their clinical signs and symptoms in~     patients suffered from mental health problems between Chinese and Western societies. The~     benefits of physical rehabilitation program in the management of depression cannot be assumed~     in the Chinese population. The purpose of this study is to investigate the effectiveness of a~     structured Physical Rehabilitation Program for Chinese patients diagnosed with depressive~     disorder (mild to severe severity) on the physical fitness and negative psychological~     symptoms of the recruited patients.~      The Hypothesis are:~        1. The Physical Rehabilitation Program is effective in improving the physical fitness in~          Chinese patients with depressive disorders.~        2. The Physical Rehabilitation Program is effective in alleviating the negative~          psychological symptoms in Chinese patients with depressive disorders.~   "
155054|NCT01536743|"~     The purpose of this study is to obtain an estimate of the biochemical response rate as~     determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria~     of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125 response is~     defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial~     evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).~   "
155055|NCT01536730|"~     The Centers for Disease Control and Prevention has declared that AIDS is a state of~     emergency in the US for African Americans - young African American men are especially~     vulnerable in this epidemic. Thus, the development of effective interventions tailored to~     this population is a national priority. The investigators previous preliminary studies~     suggest that a brief, clinic-initiated, home-based, self-guided condom use program may~     effectively promote the acceptance of condom use and increase the quality and consistency of~     condom-protected sexual behaviors. This pilot study will (1) develop and test the feasibility~     of this program (Homework Intervention Strategy, HIS) for young African American men~     attending an urban STD clinic and (2) identify variables that may mediate the efficacy of the~     program. The HIS has the potential to be readily translated into widespread practice, while~     requiring only minimal resources. Unlike previously tested interventions, the HIS can be~     applied to all men who use condoms, regardless of the sex of their partners or their HIV/STI~     status. To develop the HIS to meet the needs of these high-risk men, the proposed study will~     include a formative phase during which the basic intervention instructions which will be~     delivered by DVD will be refined and tailored for this population.~      One hundred young African American men recruited from an urban STD clinic will be randomized~     to each of two groups (HIS vs. standard of care) in a randomized 2-arm trial with 5~     assessment periods over the course of 6 months. Assessments will compare the groups on~     frequency of unprotected sex, quality of the condom use experience, experience of condom use~     errors and problems, attitudes regarding condom use, condom use acceptability, and condom use~     self-efficacy and confidence.~   "
155056|NCT01536717|"~     The purpose of this study is to examine the wound infusion of articaine for treatment of~     acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized~     design and an active control (bupivacaine)~   "
155058|NCT01536691|"~     The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and~     Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing~     of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):~      Prospective multicenter, randomized, single blinded, phase III study.~   "
155059|NCT01536678|"~     GSK markets a drug called levothyroxine or T4 that is used to treat patients with~     hypothyroidism. Till date, the active drug substance or active pharmaceutical ingredient~     (API) for levothyroxine tablets marketed in India has been obtained from a particular source.~     GSK India proposes to change the source of the API from the existing source to a new source.~     Some patients may experience a change in clinical effect when switched from one formulation~     to another. Therefore this study is being done to understand whether a change in API in~     levothyroxine tablet has any impact on the clinical effect of the drug.~      The purpose of this study is to:~      See how quickly the levothyroxine tablet from the new source (single dose of 600mcg) enters~     the bloodstream, is distributed in the body, broken down and removed compared to the~     levothyroxine tablet from the existing source (single dose of 600mcg).~      Study the effect of single 600mcg doses of levothyroxine tablet from new source and~     levothyroxine tablet from existing source on TSH level in the blood.~      Study the safety and side effects of single 600mcg doses of levothyroxine tablet from new~     source and levothyroxine tablet from existing source.~   "
155060|NCT01536665|"~     This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide~     adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects~     with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment~     with liraglutide or placebo.~      Subjects will initially be randomised to one of the three dose groups, and subsequently~     randomly allocated to one of two treatment sequences (liraglutide/placebo or~     placebo/liraglutide).~   "
155061|NCT01536652|"~     This study is conducted in Europe. The aim of this observational study is to document the~     glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic~     episodes, in patients that switched from insulin glargine combined with oral antidiabetic~     drugs (OADs) to biphasic insulin aspart 30 (NovoMix® 30) combined with OADs, when applicable.~   "
155062|NCT01536639|"~     This study is conducted in Europe. The aim of the study was to evaluate the safety and~     efficacy of biphasic insulin aspart 30 (NovoMix® 30) when switching to a modern premix~     insulin analogue treatment compared to previous insulin regimen in routine clinical practice~     in the Slovak Republic.~   "
155063|NCT01536626|"~     This study is conducted in Europe. The aim of this observational study is to observe and~     investigate the process of switching from premixed human insulin 30/70 (BHI 30) to biphasic~     insulin aspart 30/70 (BIAsp 30) in an outpatient setting.~   "
155064|NCT01536613|"~     This study is conducted in Asia. The aim of this study is to review the safety and efficacy~     of biphasic insulin aspart 30 in post-marketing use.~   "
155065|NCT01536600|"~     This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate~     biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic~     agent (OHA) for type 2 diabetes management in routine clinical practice.~   "
155066|NCT01536587|"~     This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects~     with Chronic Obstructive Pulmonary Disease (COPD) Global Initiative for Chronic Obstructive~     Lung Disease (GOLD) class II or III with the aim to demonstrate that inhaled therapy with~     salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32~     subjects is planned to be enrolled.~   "
155067|NCT01536574|"~     This open label extension study allows assessment of the long term safety profile of REQUIP~     PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.~      Subjects must not have a break in study medication between completing the feeder study and~     entering extension study, treatment must be continuous.~      Subjects will be dispensed down-titration medication at the study completion/early withdrawal~     visit and should be scheduled to return for a follow up visit 4 to 14 days after the last~     dose of study medication.~   "
155068|NCT01536561|"~     Phase I/II, single-center, dose-escalation study of the safety, pharmacokinetics, dosimetry,~     and efficacy of TST/I-131 TST for the treatment of patients with chemotherapy-refractory or~     resistant low-grade, intermediate-grade, or high-grade B-cell lymphoma. Subjects received 1~     to 3 dosimetric doses followed by a therapeutic dose of TST/I-131 TST. Study BEX104526 was a~     follow-up study of the long-term safety and efficacy data from the surviving patients who~     completed at least 2 years of follow-up following administration of TST/I 131 TST on Study~     BEX104728.~      Dosimetric dose: Subjects received 1 to 3 dosimetric doses of TST/I-131 TST, followed by a~     therapeutic dose of TST/I-131 TST. Subjects received various doses of unlabeled TST (0, 95 or~     475 mg) to determine the dose of unlabeled TST that optimized the radiation dose delivered to~     the tumor by TST/I-131 TST. The unlabeled TST was followed by 5 milliCurie (mCi) of I-131~     TST. Serial whole body sodium iodide scintillation probe counts were obtained daily, for at~     least 5 days, in order to determine the rate of whole body clearance of radioactivity~     (residence time). The residence time was used to determine the radioactive clearance for the~     subject and the activity (in mCi) of I-131 required to deliver the desired TBD of radiation~     during the therapeutic dose. Because 475 mg was determined to be the optimal pre-dose of TST~     in the first subjects entered, the last 34 subjects received a single dosimetric dose that~     was preceded by an infusion of 475 mg of TST.~      Therapeutic dose: Groups of 3-6 subjects were enrolled at successively higher whole-body~     radiation dose levels beginning at a total body dose (TBD) of 25 centiGray (cGy). The TBD of~     each subsequent dose level was escalated by 10 cGy. Subjects who had undergone bone marrow~     transplantation (BMT) underwent a separate dose escalation (10 cGy TBD increase per dose~     level) beginning at a TBD level of 65 cGy. The MTD was defined as the highest dose level at~     which 0/3 or 1/6 subjects experienced dose-limiting toxicity (DLT). DLT was defined as~     follows:~      Any Grade 4 hematologic toxicity (National Cancer Institute [NCI] criteria) lasting greater~     than 7 days, or Any Grade 3 hematologic toxicity lasting greater than 2 weeks, or Any Grade 3~     or 4 nonhematologic toxicity Redosing. Subjects who achieved tumor regression were considered~     for re-dosing, using the original therapeutic dose of TST/I-131 TST, at the time the tumor~     was no longer shrinking in an attempt to upgrade their response.~      Retreatment. Subjects who achieved partial (PR) or complete response (CR) were considered for~     retreatment following relapse of their NHL, if progression occurred ≥6 weeks following the~     therapeutic dose. The original therapeutic dose of TST/I-131 TST was given unless a grade 2~     or greater toxicity had been encountered, in which case a reduced dose was administered for~     the repeat therapeutic dose.~   "
155069|NCT01536548|"~     Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a~     button-hole technique is increasingly recommended. By using the same two sites for~     cannulation there are reports of less risk of complications and less pain for the patient.~     However, button-hole cannulation can be difficult for the dialysis nurse, and failing~     cannulations can damage the AV fistula and increase patient discomfort. The investigators~     therefore will test whether a simple marking on the skin of the direction and angle of~     cannulation used in each specific patient could improve the probability of a successful and~     painfree cannulation.~   "
155101|NCT01536132|"~     The purpose of this study is to determine the safety and efficacy of intravenous~     administration of intermittent doses of levosimendan (infusions of 0,2 μg/kg/min, of~     levosimendan or placebo, without bolus, for 6 hours every 2 weeks) compared to placebo in~     ambulatory patients with advanced chronic heart failure.~   "
155070|NCT01536535|"~     This is a multi-center, open-label study to determine the safety and effectiveness (how well~     it works) of two standardized treatments called mesalamine (Pentasa®) and prednisone in~     children with newly diagnosed UC. Standardized treatments are types of treatments agreed upon~     and used by many qualified doctors. The medications being used in this study are considered~     standard of care. Currently the ways in which these medicines are used (doses, frequency of~     dosing) may vary from site to site. This study will determine response to a standardized way~     of giving these medicines.~      This study will also identify biomarkers for ulcerative colitis. Biomarkers are things that~     doctors can find in blood, stool, or bowel tissue that indicate how much inflammation there~     is in the bowel, how the inflammation is produced, and whether the inflammation is responding~     to treatment. Collecting response and remission (free of symptoms) information on these~     standardized treatments and the biomarkers can possibly help doctors create a model, or~     plan to know which children with UC may respond quickly, or which children may develop~     complications.~   "
155071|NCT01536522|"~     The overall goal of the Asthma Inflammation Research [AIR] Translational Program is to create~     an integrated multidisciplinary team for the focused purpose of development of diagnostic and~     prognostic tests informative for airway inflammation, and for the design of innovative,~     targeted biologic therapeutics.~      The overarching aims of the AIR program are to conceptualize, develop, and test the~     next-generation therapeutics, and novel asthma diagnostic and prognostic tools that will~     allow us to improve the standard of asthma care.~   "
155072|NCT01536509|"~     The purpose of the study is to test an online behavioral intervention to improve medication~     adherence in children diagnosed with Inflammatory Bowel Disease. Interested families will be~     monitored for four weeks to determine how frequently their child's IBD medication is taken.~     Patient's taking less than 90% of medications will be randomized to one of two intervention~     conditions to complete intervention sessions online. The study consists of 4 online~     intervention sessions with topics differing by condition and 5 online assessments to complete~     quality of life questionnaires over a 14 month time frame.~   "
155073|NCT01536496|"~     The purpose of this study is to compare rapid thrombelastography (r-TEG) with conventional~     coagulation testing for diagnosing and treating coagulation abnormalities in severely injured~     patients who are likely to require transfusion therapy.~   "
155074|NCT01536483|"~     Clinical management of very low birth weight newborns (VLBW <1250g) consists in several~     challenges to adapt immature physiological systems to extrauterine life. Advances in neonatal~     medicine for pulmonary and/or neurological and/or cardiovascular diseases have significantly~     improved outcomes of these children. However, the gastro-intestinal (GI) tract remains a~     major cause of morbidity due to~        1. the immaturity of GI functions (prolonged ileus, bacterial overgrowth and~          translocation),~        2. the complication of GI tract immaturity: intestinal perforation and enterocolitis~          necrotizing)~        3. the need of a prolonged parenteral nutrition and its complications (central venous~          catheter infections, sepsis, electrolyte disturbances) but without generate a high proof~          level on this targeted population (<1250g).~      The GI functions are progressively acquired during development and are largely sensitive to~     the environment, especially the intestinal luminal content. Indeed, probiotics and prebiotics~     have shown beneficial effects upon GI functions of newborns. One of the metabolite of the gut~     flora potentially involved is the butyrate. Butyrate is a short chain fatty acid produced in~     the colon by the microbiota (carbo-hydrates degradation). The colonic amount of butyrate~     increases gradually after birth. The beneficial effects of butyrate are related to its~     properties upon the epithelial barrier (anti-inflammatory, antioxidant, barrier repair) and~     upon the enteric nervous system (network of neurons and glial cells) that regulate GI~     functions and in particular colonic motility.~      To date, there is no clinical consensus to manage digestive disorders of VLBW. Several~     clinical studies have assessed the effects of prokinetic drugs, dietary supplements~     (probiotics, prebiotics) but without generate a high proof level on this targeted population.~     In this context, a recent study of our Research Unit (INSERM-CIC Mère-Enfant 004) has shown~     benefit effects of oral probiotics supplementation in children with birth weight greater than~     1000g but not in extreme preterms with birth weight less than 1000g.~      The main hypothesis to explain theses results lies in the intensive use of antibiotic and~     feeding interruption frequency in this targeted population which induce disturbances in the~     composition of the gut lumen (in particular the flora).~      Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate~     a clinical efficiency upon the colonic transit, underlying by mechanical and osmotic~     mechanisms.~      Here, the investigators propose to evaluate the clinical efficiency of butyrate enemas by a~     prospective randomized clinical trial blinded design.~      The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the~     nutritional management of extreme preterm less than 1250 grams, by facilitating the~     development of colic motility and clinical nutrition tolerance.~   "
155075|NCT01536470|"~     The purpose of this study is to evaluate whether a preventive strategy of intraoperative~     arterial hypotension using noradrenaline can reduce the incidence of postoperative organ~     failure.~   "
155076|NCT01536457|"~     There have been a number of studies which attribute causality between reflux disease and~     asthma. In addition, clinicians typically treat chronic asthmatics with high dose acid~     suppressing medications (e.g. lansoprazole). However, clinical trials only recently have shed~     some light on this dilemma, with recent studies suggesting that the association is not as~     clear. This retrospective analysis of a prospective study which treated mod-severe~     asthmatics with lansoprazole or placebo will enter the collected raw data into a database,~     then perform statistical analyses to determine if children with asthma treated with acid~     suppression improved their asthma compared to those receiving placebo.~   "
155077|NCT01536444|"~     This case series will assess the use of suction blister epidermal grafts harvested by a novel~     device on select patients that have wounds from Mohs or excisional surgery.~   "
155078|NCT01536431|"~     The purpose of this study is to address the safety issue of whether, in patients with~     newly−diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely~     affects the rate of damage to the insulin making cells.~   "
155079|NCT01536418|"~     This is a multi-centre, randomised, double-blind, active treatment, parallel group induction~     study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive~     one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for~     12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease~     Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI~     score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to~     qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary~     objectives will include assessment of the safety and evaluation of the efficacy in induction~     of clinical response or remission. Safety will be assessed by recording of adverse events and~     assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram.~     Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes~     assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D,~     and Work Productivity and Activity Impairment-Crohn's Disease.~   "
155080|NCT01536405|"~     This study will compare the safety, tolerability, and immunogenicity of measles, mumps,~     rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with~     those of the 2006 process~   "
155081|NCT01536392|"~     The goal of this clinical research study is to compare granisetron (when given through a~     patch) to ondansetron (when taken by mouth) for reducing nausea and vomiting in women with~     cervical, endometrial, or vaginal cancer having chemoradiation.~      Granisetron and ondansetron are designed to help reduce nausea and vomiting.~   "
155097|NCT01536184|"~     Study Summary: This study is being conducted in order to rigorously evaluate the real-world~     effectiveness of a publicly-funded, home-based, attachment-focused intervention Circle of~     Security (COS) Family Intervention Model (Marvin) in improving caregiving and child outcomes~     in families who have children with Fetal Alcohol Spectrum Disorder (FASD) or who are at-risk~     for FASD, as delivered under routine practice conditions.~      Hypothesis: At post-test (after 36 sessions and 3-month follow-up), compared to a wait-list~     control group receiving standard services, the treatment group receiving COS will show~     greater improvement in caregiver behaviour, as well as child emotional and behavioural~     outcomes.~   "
155098|NCT01536171|"~     This experimental study will compare impact forces and metabolic cost in runners (N=20; ages~     18-45 years, who already use a forefoot strike running gait) in two treadmill running test~     sessions (shod vs barefoot running)~   "
155099|NCT01536158|"~     The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better~     or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.~   "
155082|NCT01536379|"~     Kidney transplantation is the best treatment for many patients with kidney failure. Sometimes~     a transplanted kidney is rejected by the patient's immune system. Many types of immune system~     cells, including B cells, are active in rejection. B cells produce antibodies against~     anything the body sees as non-self, like germs or a transplanted kidney. Most medicines that~     help prevent transplant rejection affect cells other than B cells. Belimumab is a medication~     used to treat a disease called lupus. Belimumab slows development of antibody-producing B~     cells. This study will test whether belimumab works on parts of the immune system that cause~     rejection. Twenty to thirty adults getting a kidney transplant will be in this study. Like~     flipping a coin, a computer will randomly assign half to be given belimumab and half to be~     given placebo (a fake medicine). Patients and doctors will not know which medicine was~     assigned until the study is over. A total of 7 doses of study medicine will be given through~     a vein. One dose will be given during transplant surgery, and the other 6 will be given 2, 4,~     8, 12, 16 and 20 weeks after transplant surgery. Usual transplant medicines will also be~     given. After all of the doses have been given, patients will be watched and tested at 24, 36,~     and 52 weeks after the transplant surgery. Blood samples will be tested to see what study~     medicines do to the immune system in transplant patients. If patients get a kidney biopsy,~     the samples will be tested to see if belimumab had any effect. Patients will be asked many~     questions to see if they are having any side effects. The study will be done at Addenbrooke's~     Hospital in Cambridge and Guys &St Thomas Hospital in London, United Kingdom. A~     pharmaceutical company, GlaxoSmithKline, is funding the study.~   "
155083|NCT01536366|"~     The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.~   "
155084|NCT01536353|"~     The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet in~     healthy male volunteers.~   "
155085|NCT01536340|"~     The purpose of this study is to:~      -Determine the incidence of adverse events, preventable adverse events, and ameliorable~     adverse events, and the timeliness of post-discharge ambulatory appointments, affecting urban~     and rural patients approximately 3-4 weeks after discharge from a hospitalist-run medical~     service of a large community hospital to home.~      H1: The incidence of post-discharge adverse events will be higher in rural patients compared~     with urban patients discharged from a hospitalist-run medical service of a large community~     hospital.~      -Identify and classify the types of post-discharge adverse events (e.g., adverse drug events,~     procedure-related events, hospital acquired (nosocomial) infections, falls, and other)~     affecting urban and rural patients approximately 3-4 weeks after discharge from a~     hospitalist-run medical service of a large community hospital to home.~      H2: All patients will be at higher risk for adverse drug events than other types of adverse~     events.~      -Examine the relationships between the population at risk, characteristics of the health care~     delivery system, and the utilization of post-discharge health services, and how these~     relationships help us understand the incidence of post-discharge adverse events.~      H3: Several factors will be independently associated with the incidence of post-discharge~     adverse events in rural and urban patients, including patient comorbidity, severity of acute~     illness, presence of a primary care physician prior to hospitalization, and a scheduled~     timely post-discharge ambulatory follow-up appointment.~   "
155086|NCT01536327|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     metachromatic leukodystrophy disease from plasma. Testing for clinical robustness,~     specificity and long-term stability of the biomarker.~   "
155087|NCT01536314|"~     The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2~     weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared~     to placebo group.~   "
155088|NCT01536301|"~     The main objective is to demonstrate that postoperative analgesia by IV oxycodone (compared~     to morphine IV) reduces opioid-related adverse events (nausea, vomiting, pruritus,~     respiratory depression, urinary retention, allergies, hallucination) by 50% in adult patients~     operated on for prosthetic hip surgery.~   "
155089|NCT01536288|"~     Traditional folk medicine in the Arctic and Himalayan areas used Rhodiola species to enhance~     physical endurance, prevent aging, resist acute mountain sickness (AMS), and to treat~     fatigue, depression, anemia, impotence and respiratory infections. Rhodiola crenulata are~     widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by~     human study. The investigators conducted a randomized, double blind, placebo controlled,~     crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.~   "
155090|NCT01536275|"~     In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the~     first week in critically ill children is beneficial, compared to the current standard of the~     early start of parenteral nutrition.~   "
155091|NCT01536262|"~     The primary objective of this study is to assess the safety of 52 weeks once daily treatment~     with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT~     Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
155092|NCT01536249|"~     This study will assess the effect of cimetidine on the pharmacokinetics (PK) of~     dexpramipexole in healthy volunteer and evaluate the safety and tolerability of~     dexpramipexole when given with or without cimetidine. Additionally, this study will explore~     the influence of genetic variation on the PK of dexpramipexole when given with or without~     cimetidine.~   "
155093|NCT01536236|"~     To obtain preliminary estimates of the safety and efficacy of the ANS Eon™ Implantable Pulse~     Generator with ANS leads in the treatment of subjects with diabetic polyneuropathy.~   "
155094|NCT01536223|"~     Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive~     either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF)~     neoadjuvant chemotherapy with concurrent chemoradiation.~   "
155095|NCT01536210|"~     This study will evaluate clinical efficacy and safety of treatment with YY-162 in children~     with ADHD.~   "
155096|NCT01536197|"~     The investigators wish to study the effects of three forms of bariatric surgery, gastric~     bypass lap banding, and sleeve gastrectomy. The surgery is not part of the clinical trial. If~     your insurance does not cover the procedure, then the patient is responsible for payment of~     the surgical process. The investigators are doing pre and post surgery testing to provide a~     better understanding of the effect of bariatric surgery-induced weight-loss on taste~     perception.~   "
155103|NCT01536106|"~     The primary objective of the study is to determine the feasibility and safety of~     intracoronary administration of autologous bone marrow derived mononuclear cell product in~     patients at risk for clinically significant cardiac dysfunction following AMI.~      The secondary objective of the study is to assess the effect on cardiac function and infarct~     region perfusion. A concurrent placebo control patient group meeting eligibility but not~     receiving autologous bone marrow derived stem cells will be evaluated similar to the treated~     group to assess the rate of significant spontaneous improvement in cardiac function.~   "
155104|NCT01536093|"~     Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory~     protection against nosocomial infection in extremely premature infants. However, most of them~     could not proceed enteral feedings due to clinical instability in the first few days. Recent~     studies supports oropharyngeal administration as a potentially safe and effective delivery~     method for immunologic benefits and only small amount of colostrum could be administrated for~     immune therapy for extremely premature babies. The purpose of this study is to determine the~     beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in~     extremely low gestational age infants and evaluated the safety of this method to extremely~     premature infants in the first few days of life.~   "
155105|NCT01536080|"~     Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final~     diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even~     functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal~     symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the~     measurement of GERD symptoms and response of proton pump inhibitor in short time. Several~     questionnaires have been made for the assessment of GERD symptoms in recent years However,~     their screening tools do not include the impact of symptoms on everyday life and take a long~     time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been~     developed to compensate for this. It is a simple, one-page, questionnaire to communicate to~     the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing~     that it might also prompt clinicians to make appropriate treatment for patients' symptoms.~     However, there was no report regarding comparison of the characteristics and response to PPI~     in RE, NERD and FH groups using GIS questionnaire so far.~   "
155106|NCT01536067|"~     This phase II trial studies how well giving ofatumumab together with bortezomib works in~     treating patients with previously untreated Waldenstrom macroglobulinemia. Monoclonal~     antibodies, such as ofatumumab and bortezomib, can block cancer growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help~     kill them or carry cancer-killing substances to them. Giving ofatumumab together with~     bortezomib may be a better way to block cancer growth~   "
155107|NCT01536054|"~     This phase I trial studies the side effects and best dose and schedule of sirolimus when~     given together with vaccine therapy in treating patients with stage II-IV ovarian epithelial,~     fallopian tube, or primary peritoneal cavity cancer. Sirolimus may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Vaccines made from a~     gene-modified virus may help the body build an effective immune response to kill tumor cells.~     Giving vaccine therapy together with sirolimus may be an effective treatment for ovarian,~     fallopian tube, or primary peritoneal cancer~   "
155108|NCT01536041|"~     The primary objectives of this study are:~      i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on~     exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced~     expiratory volume in 1 second (FEV1) after exercise challenge~      ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg~     of ONO-6950 in asthmatic patients.~      The secondary objectives of this study are:~      i. to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus~     montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise~     challenge~      ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg)~     single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.~   "
155109|NCT01536028|"~     This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics~     and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin~     aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.~   "
155110|NCT01536015|"~     The primary purpose is to demonstrate superiority of Rotigotine over Placebo on motor~     symptoms when used in subjects with symptoms of Gastrointestinal Dysfunction. Hypothesis:~     Rotigotine will decrease OFF time compared to Placebo.~   "
155111|NCT01536002|"~     The objectives of this study are~        -  To determine PK of propofol in bariatric patients~        -  To identify the physiological variables that induce propofol PK changes in bariatric~          patients, when compared to a normal-weight population.~        -  To define context-sensitive half-time profiles for propofol in bariatric patients.~   "
155112|NCT01535989|"~     This is an open label phase I study of Inotuzumab Ozogamicin, an antibody-targeted~     intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin,~     in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in~     patients with relapsed/refractory CD22+ B-cell non Hodgkin's lymphomas (NHLs). Both~     Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in~     combination with rituximab in patients with NHLs. This is the first study combining the two~     agents together. In the present study Inotuzumab Ozogamicin will be administered~     intravenously on d1 at the starting dose of 0.8 /m2. Temsirolimus will be administered~     intravenously on days 1,8,15 and 22 at the starting dose of 15mg. Cycles will be repeated~     every 28 days.~   "
155113|NCT01535976|"~     Procedures performed under sedation have the same severity in regards to morbidity and~     mortality as procedures performed under general anesthesia1. The demand for anesthesia care~     outside the operating room has increased tremendously and it poses, according to a closed~     claim analysis, major risks to patients . Both closed claim analysis identified respiratory~     depression due to oversedation as the main risk to patients undergoing procedures under~     sedation. The major problem is that hypoventilation is only detected at very late stages in~     patients receiving supplemental oxygen. Besides the respiratory effects of hypoventilation,~     hypercapnia can also lead to hypertension, tachycardia, cardiac arrhythmias and seizures.~      The incidence of anesthetized patients with obstructive sleep apnea has increased~     substantially over the last years along with the current national obesity epidemic. These~     patients are at increased risk of hypoventilation when exposed to anesthetic drugs. The~     context of the massive increase in procedural sedation and the extremely high prevalence of~     obstructive sleep apnea poses major respiratory risks to patients and it may, in a near~     future, increase malpractice claims to anesthesiologists. The development of safer anesthesia~     regimen for sedation are, therefore, needed. The establishment of safer anesthetics regimen~     for sedation is in direct relationship with the anesthesia patient safety foundation~     priorities. It addresses peri-anesthetic safety problems for healthy patient's. It can also~     be broadly applicable and easily implemented into daily clinical care.~      Ketamine has an established effect on analgesia but the effects of ketamine on ventilation~     have not been clearly defined. The lack of validated and sensitive instruments to evaluate~     the effects of ketamine on ventilation is an important reason for the conflicting results.The~     investigators have demonstrated that the transcutaneous carbon dioxide monitor is accurate in~     detecting hypoventilation in patients undergoing deep sedation. Animal data suggest that when~     added to propofol in a sedation regimen, ketamine decreased hypoventilation when compared to~     propofol alone. It is unknown if ketamine added to a commonly used sedative agent (propofol)~     can decrease the incidence and severity of hypoventilation in patients undergoing deep~     sedation. It is also unknown if the effect of ketamine on ventilation are different in~     patients with and without obstructive sleep apnea.~      The investigators hypothesized that patients receiving ketamine and propofol will develop~     less intraoperative hypoventilation than patients receiving propofol alone. The investigators~     also hypothesized that this effect will be even greater in patients with obstructive sleep~     apnea than patients without obstructive sleep apnea.~      Significance: Respiratory depression due to oversedation was identified twice as the major~     factor responsible for claims related to anesthesia. The high prevalence of obstructive sleep~     apnea combined with more complex procedures done in outpatient settings can increase physical~     risks to patients and liability cases to anesthesiologists. The main goal of this project is~     to establish the effect of ketamine in preventing respiratory depression to patients~     undergoing procedures under sedation. If the investigators confirm the their hypothesis ,~     their findings can be valuable not only to anesthesiologist but also to other specialties (~     Emergency medicine, gastroenterologists, cardiologists, radiologists) that frequently~     performed procedural sedation. The research questions is;does ketamine prevent~     hypoventilation during deep sedation? The hypotheses is; ketamine will prevent~     hypoventilation during sedation cases.~   "
155114|NCT01535963|"~     The primary objective of this study is to measure the overall level of satisfaction in~     patients after cutaneous surgery in 4 different categories, including the surgeon, facility,~     procedure and recovery and outcome.~   "
155115|NCT01535950|"~     This study will assess the safety and efficacy of LFG316 in patients with age related macular~     degeneration.~   "
155116|NCT01535937|"~     This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the time~     to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent~     individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week~     combined laboratory-inpatient and outpatient double-blind, randomized, controlled trial.~   "
155117|NCT01535924|"~     This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride~     when given together with gemcitabine hydrochloride and to see how well it works in treating~     patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as~     gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug, combination chemotherapy, may kill more cancer cells.~   "
155118|NCT01535911|"~     This study will look at the effects, good and/or bad, of treating primary brain cancers with~     diet therapy using an energy restricted ketogenic diet (ERKD) that uses food. An energy~     restricted ketogenic diet is a diet designed to keep blood sugars in the low range of normal~     while at the same time increasing the blood concentration of metabolic break down products~     called ketones. This diet is currently used to treat children with uncontrollable seizures.~     This diet is well tolerated by the children with minimal side effects reported after using~     the diet for years.~        -  The main purpose of this study is to find out whether or not the energy restricted~          ketogenic diet will help patients with primary brain cancer by either decreasing the~          size of the cancer or by keeping the cancer from growing.~        -  Another reason for doing this study is to learn about the side effects associated with~          the energy restricted ketogenic diet in patients with primary brain cancer.~   "
155119|NCT01535898|"~     Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the~     body using magnetic field and radio frequency pulses that can not be felt. The purpose of~     this study is to determine if a new MR imaging method can help tumor evaluation in head and~     neck cancer or prostate cancer. The extra images will be obtained using Diffusion-weighted~     Magnetic Resonance Imaging which provides image contrast through detection of small~     restrictions in the movement of water molecules. This study may help us provide additional~     information about the tumor along with the picture of the organ.~   "
155120|NCT01535885|"~     This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus~     Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a~     related family member or an unrelated donor. Recipients of these types of transplants are~     severely immune compromised during the early post-transplant period and are more susceptible~     to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T~     Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus~     (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or~     other infusion related toxicities.~   "
155121|NCT01535872|"~     The aim of this study is to show solid evidences of the efficacy of DHEA in improving the~     success rates of in-vitro fertilization (IVF) patients facing poor ovarian reserve.~   "
155122|NCT01535859|"~     The purpose of this study is to determine whether cabergoline is effective in reducing the~     incidence and severity of Ovarian Hyperstimulation Syndrome (OHSS), especially for severe~     cases; and to derive biomarkers for the risk of developing OHSS.~   "
155123|NCT01535846|"~     Energy-restricted diets often require dieting rules, which forced the dieter to eat according~     to cognitive norms, which increase his vulnerability to external food cues. Allowing the~     recognition of internal hunger and satiety cues by using conscious food tasting could be~     helpful among restrained eaters to facilitate an internalized regulation of food intake.~      The objectives of the proposed study are to investigate among restrained women whether~     conscious food tasting can influence 1) attitudes and behaviors associated with food and~     eating; 2) reliance on hunger and satiety signals; and 3) development of taste and olfactory~     memory.~      Females (n=50) will be randomly assigned to: 1) experimental group (conscious food tasting~     intervention) (n=24), or 2) control group (n=26). The conscious food tasting intervention~     will be conducted by a registered dietitian into groups of ten to twelve women during six~     weekly 2-hour workshops. Women in the control group will not receive any intervention.~     Measurements will be taken at baseline, at the end of the intervention period, and at 12-week~     post-intervention. Restraint Scale, Three-Factor Eating Questionnaire, Mindful Eating~     Questionnaire, Intuitive Eating Scale, Body-Esteem Scale and Rosenberg Self-Esteem Scale will~     measure attitudes and behaviors associated with food and eating as well as some aspects~     related to psychological functioning. The Intuitive Eating Scale and a snack-meal taste~     rating task (visual analogue scales) will assess internal hunger/satiety cues. Vocabulary~     used to describe the foods will be recorded from the snack-meal taste rating task and use to~     assess taste and olfactory memory. Sensory capabilities will be assessed by odour detection~     and identification test, and a taste detection test.~      The proposed study will provide a better understanding of the effects of conscious food~     tasting on eating attitudes and behaviors, which is relevant to dietetic practice as it could~     help to promote sustainable healthy eating habits.~   "
155124|NCT01535833|"~     The investigators scientific aims are to determine the benefits associated with the use of~     robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how~     the benefits impact the patient, physician and the institution, and to determine the~     complications associated with the use of the robot. This will be a prospective cohort~     following 100 patients for a 24 month period.~   "
155125|NCT01535820|"~     The purpose of this study is to assess the bioequivalence of the contraceptive hormones of~     ORTHO EVRA when the patch is applied with and without an adhesive overlay.~   "
155126|NCT01535807|"~     The objective of this study is to identify proteomic inflammatory biomarkers to determine if~     there are differences in the biomarkers in patients who are treated using the CorMatrix ECM~     implant to close the pericardium and the patients whose pericardium is left open (the current~     standard of care).~   "
155127|NCT01535794|"~     The FDA has recently approved Gardasil for the prevention of anal cancer in people aged 9-26.~     Men who have sex with men (MSM) have disproportionately high rates of anal cancer and could~     benefit greatly from vaccination. Vaccine uptake among young MSM (YMSM) is poor, and little~     is known about factors associated with vaccine acceptance in this population. With the risk~     of anal cancer among MSM higher than the risk of cervical cancer among women before routine~     cytological screening was introduced, acceptance of a prophylactic vaccine in this subgroup~     is the most cost-effective and attainable strategy to greatly reduce the prevalence of anal~     cancer. While the investigators can assume the human papillomavirus (HPV) vaccine has many~     acceptable concepts among these men, there are multiple barriers which may potentially~     interfere with their likelihood of initiating the vaccine series. Vaccine catch-up rates~     among women of a similar age has been poor, and there is no reason to expect this to be~     higher among men. One potential strategy to increase vaccine uptake in this catch-up group is~     to implement a patient-driven program to promote vaccination among men.~      This project will contribute to the investigators understanding of how the investigators can~     utilize social networks to identify barriers to HPV vaccination among YMSM, and how to~     potentially influence a patient-driven vaccination effort to increase uptake among men in the~     catch-up age group. This research will inform future interventions to targeted populations~     that may be incorporated into online social networking websites to encourage HPV vaccination.~   "
155128|NCT01535781|"~     The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with~     pertrochanteric hip fractures.~      Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to~     investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss~     in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip~     fracture.~      An interim analysis was planned when reaching 60 inclusions. The interim analysis was~     conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was~     considered a reason to halt the study. The 0.001 level was chosen as a simple approach to~     this interim analysis from the Haybittle-Peto boundary~   "
155129|NCT01535768|"~     After implantation of an Ahmed glaucoma valve in patients with glaucoma, hyperencapsulation~     phase is an unwanted postoperative phenomenon, typically occurring with the free 3 months~     postoperatively. When this does occur, it is treated with aqueous suppressant eye drops.~      This study aims to determine if it is possible to reduce the rate of hyperencapsulation~     phase. Patients in the treatment group will receive aqueous suppressant eye drops before the~     hyperencapsulation phase starts. Treatment will be initiated once their intraocular pressure~     is above a pre-defined level, and will target a pre-defined range.~   "
155130|NCT01535755|"~     The investigators use a protocol to wean from noninvasive mechanical ventilation.~   "
155131|NCT01535742|"~     The purpose of this study is to determine whether there is a clinically relevant difference~     in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate~     through the Ambu Aura-i or air-Q ILA.~   "
155132|NCT01535729|"~     This prospective observational study will evaluate the efficacy and safety of Tarceva~     (erlotinib) in elderly patients with advanced non-small cell lung cancer (NSCLC) after~     failure of at least one prior chemotherapy regimen. Data of patients treated with Tarceva in~     routine clinical practice will be collected for 1 year.~   "
155133|NCT01535716|"~     Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical~     care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic~     optimizations are more efficient when based on the dynamic parameters than when based on the~     statics ones, and the major dynamic criteria is the cardiac output. Unfortunately,~     transpulmonary thermodilution, the device considered as The gold standard to evaluate~     cardiac output is associated with many complications.Furthermore, devices commercialized in~     the past decade were not able to replace the transpulmonary thermodilution.~      As all monitoring devices aren't reliable enough to be widely used in practice they are left~     aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on~     the analysis of several clinical parameters seems to guarantee good cares thanks to a~     favorable benefits/risks balance, it could be improved by new plug and play mini-invasive~     systems.~      In the investigators opinion, the ECOM system seems able to provide a monitoring tool which~     responds to all the expectations of a modern hemodynamic monitoring device. It uses a well~     known technique, the bioimpedance. The investigators suppose this device should be more~     efficient than the one that has been used before. Indeed, as the system is build on the~     endotracheal tube, it comes closer to the aorta, where all the measures are made, and the~     recorded signal should be less affected by the passage through the surrounding tissues.~      This randomized and controlled trial will study Patients scheduled for elective coronary~     surgery with cardiopulmonary bypass.~      The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed~     hemodynamic therapy based on the ECOM cardiac output measure on mortality and major~     postoperative cardiac morbidity after coronary surgery, when compared with a standard~     management strategy.~      Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard~     management strategy, applied to the control group, will be set and led by the attending~     anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face~     the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and stroke~     volume variation.~      The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure~     will reduce mortality and morbidity after cardiac surgery.~   "
155134|NCT01535703|"~     Monitoring could secure management for patient but stay invasive. The purpose of this study~     was to compare,after cardiac surgery, the cardiac output measurement between transpulmonary~     thermodilution(reference method) and digital photoplethysmography (non invasive) for absolute~     value and dynamics changes before and after fluid expansion for patients with indication of~     fluid challenge.~   "
155135|NCT01535690|"~     Background: Photodynamic therapy (PDT) is a method of microbial reduction which can benefit~     periodontal treatment in areas of difficult access, such as deep pockets and furcations. The~     aim of this randomized controlled clinical trial was to evaluate the effects of PDT as an~     adjunct to full-mouth ultrasonic debridement in the treatment of severe chronic~     periodontitis.~      Methods: Twenty-two patients with at least one pocket with probing depth (PD) ≥ 7 mm and one~     pocket with PD ≥ 5 mm and bleeding on probing (BOP) on each side of the mouth were included,~     characterizing a split mouth design. The control group underwent full-mouth ultrasonic~     debridement and test group received the same treatment associated with PDT. The following~     clinical parameters were evaluated: plaque index, gingival index, BOP, gingival recession~     (GR), PD, and clinical attachment level (CAL). All parameters were collected before, 1, 3 and~     6 months after treatment.~   "
155136|NCT01535677|"~     This is an open-label, randomised study to compare the similarity of a combination~     Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and~     fed conditions in healthy volunteers.~   "
155137|NCT01535664|"~     The purpose of this study is to determine changes on overall gait as well as in multiple gait~     and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are~     receiving the medication consistently for at least two weeks prior to screening.~   "
155138|NCT01535651|"~     The investigators are exploring the use of short message service (text) messaging by cell~     phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy~     prevention program.~   "
155139|NCT01535638|"~     The primary objective of the current study is to investigate the relative bioavailability of~     three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation~     (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and~     administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy~     volunteers, with the aim to compare the bioavailability of the three formulations. All~     treatments will be applied fed, 30 minutes after start of the intake of a standard normal~     breakfast.~   "
155140|NCT01535625|"~     This study evaluates the safety and effectiveness of the Momo Cobalt Chromium stent system~     for the treatment of single de novo lesions in a native coronary artery. The stent is coated~     with diamond-like carbon to decrease the risk of acute and late stent thrombosis, to increase~     the resistance towards corrosion and to significantly improve endothelialisation through the~     inhibition of elution of metallic ions.~   "
155141|NCT01535612|"~     The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes~     (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch~     on insulin delivery device) to control his/her blood glucose.~   "
155143|NCT01535586|"~     Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder~     (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in~     patients with PTSD compared to those without PTSD and contribute to worsening cognitive and~     behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment~     of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general~     population. The proposed study aims at comparing the efficacy, tolerability, and adherence of~     mandibular advancing devices-an alternative therapy to OSA- to CPAP. The study is~     instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA~     phenotype that would predict MAD response.~   "
155144|NCT01535573|"~     This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine~     dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent~     patients will be assigned equally to one of three medication conditions: placebo or the~     Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or~     40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase~     periods of sustained abstinence substantially more than placebo. Performance on a set of~     behavioral tasks of impulsivity will be analyzed as potential predictors of treatment~     response.~   "
155145|NCT01535560|"~     The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle~     based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa~     (AOE).~   "
155146|NCT01535547|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of tacrolimus after single dose administration.~   "
155147|NCT01535534|"~     During the past years many investigators have focused on the immunological changes in sepsis~     disease, and great attention has been paid to the development of practicable means of~     immunomonitoring. Little is known about diagnostic and prognostic vascular biomarkers during~     the time course of patients with sepsis.~   "
155148|NCT01535521|"~     The investigators will perform a clinical trial comparing mandibular advancement device (MAD)~     therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in patients~     with positional sleep apnea using MAD. Patients are invited for 2 consecutive~     polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD.~     PSGs are performed at the Antwerp University Hospital.~   "
155149|NCT01535508|"~     Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation,~     titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in~     vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients.~      The study will determine if initial safety and effect estimates predict that a double blind~     randomized control trial (RCT) with a larger set of patients will be worthwhile in the~     localization of this treatment aimed at improving the symptoms of ASDs.~      Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core~     symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior,~     and sleep, as determined by parental and clinical evaluation scales.~   "
155150|NCT01535495|"~     This study is investigating if the oral beta antagonist propranolol can induce regression of~     retinal neovascularization associated with proliferative diabetic retinopathy.~   "
155151|NCT01535482|"~     The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT)~     with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of~     suicide ideation (SI) and the severity of depression and hopelessness among older men. The~     investigators expect that suicidal older men randomly assigned to the CT intervention~     condition will have a lower rate of SI during the follow-up period than participants assigned~     to the control condition.~   "
155152|NCT01535469|"~     This will be a stepped wedge randomized trial design to evaluate the implementation of~     cryptococcal antigen (CRAG) screening and preemptive anti-fungal therapy of HIV-infected~     persons entering antiretroviral therapy (ART) outpatient treatment in Uganda. Those who are~     ART eligible with a CD4≤100 cells/mcL will have a serum/plasma CRAG performed by lateral flow~     assay. Those who are CRAG-positive and asymptomatic will be treated with high dose~     fluconazole. After 6 months survival with retention-in-care will be compared between those~     who are CRAG+ and CRAG negative~   "
155153|NCT01535456|"~     The main purpose of this study is to see if this tracer can be used to determine how well~     chemotherapy is working in patients with certain types of leukemia.~   "
155154|NCT01535443|"~     Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in~     healthy volunteers.~   "
155155|NCT01535430|"~     Purpose of the study:~      AIM 1 Prospectively collect pre-operative (fMRI, DTI, MEG) and intra-operative mapping data~     in patients with intra-axial brain tumors to assess how well each modality predicts the~     location of eloquent brain function. In addition, each modality will be compared with the~     other.~      AIM 2 Assess reorganization of eloquent brain function and plasticity in patients with~     intra-axial brain tumors. This will be accomplished by prospectively collecting~     post-operative mapping studies and neuropsychological tests to compare them to prior mapping~     studies as stated above.~   "
155156|NCT01535417|"~     The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new~     herbal anti-arthritic agent, in patients with osteoarthritis of the knee.~   "
155157|NCT01535404|"~     The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection~     fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the~     left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular~     systolic function (>= 45%).~   "
155158|NCT01535391|"~     This study is an open-label, multicentric, phase IIIb study of NILOTINIB administered orally~     twice daily for 24 months and indefinitely if it is in the interest of the patient.~      The primary objective of the trial is to evaluate the efficacy of nilotinib, 300 mg twice~     daily with dose increase to 400 mg twice daily in case of suboptimal response or failure~     (excluding patients who will fail for progression to ABP), in a population of patients with~     Ph-positive, BCR-ABL positive CML in early CP.~   "
155159|NCT01535378|"~     If etiologies of temporomandibular disorders (TMD) are various, parafunctions become more and~     more important. Treatment of patients presenting TMD is based on conservative and reversible~     therapeutics. The behavioural reeducation of these patients which aims at decreasing their~     parafunctions is a treatment often performed.~   "
155160|NCT01535365|"~     Muscle sprains of the back and neck are very common. In addition to pain and antiinflammatory~     medications the use of either cold or hot packs has been recommended. In the current study we~     will compare ice packs and heat packs to see which is more effective at relieving pain from~     back and neck sprains while in the Emergency Department.~   "
155161|NCT01535352|"~     Low income mothers of young children represent a disadvantaged group who are at exceptional~     risk for depressive syndromes and who have increasingly limited access to mental health~     services. The proposed project is designed to evaluate Mom-Net, an internet-facilitated~     cognitive-behavioral(CBT) intervention for depression, adapted from Lewinsohn's Coping with~     Depression Course, and tailored to mothers of young children. Mom-Net, which was developed~     and piloted in an recently completed NIMH-funded investigation (MH070426), was designed to~     overcome the substantial barriers to treatment participation that exist for mothers~     experiencing economic hardship and those in rural communities. Though the pilot trial~     demonstrated that the program was very effective in reducing depressive symptoms and related~     difficulties, it was conducted under the 'idealized' conditions typical of initial~     intervention tests (e.g., computers and internet connections were supplied to all~     participants; access to the internet was provided by a single browser; coaches who provided~     weekly phone support were research staff, and initial recruitment and motivational interviews~     sessions were conducted via home visits to participants). These conditions likely facilitated~     recruitment and retention of participants, as well as ease and fidelity of treatment~     delivery. Thus one goal of the current project is to evaluate the intervention under~     conditions that are closer to those of real-world service providers and recipients. The~     current project is also intended to provide a more rigorous test of the intervention than did~     the pilot in a number of ways. Participants in the pilot trial will be 300 mothers of 3-5~     year old children recruited through Head Start classrooms and prescreened for the presence of~     elevated depressive symptoms.Subsequent to the pre-intervention assessment, participants will~     be randomized to either the intervention or facilitated usual care (FUC) condition. The~     evaluation of the intervention will focus on maternal depressive symptoms, parenting~     behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month~     intervals) will enable us to examine maintenance of effects. Overall, the investigation will~     contribute to the evidentiary base regarding the dissemination potential of this~     empirically-supported intervention, adaptations to which have the potential to enable a~     greater proportion of the population to access and benefit from it.~   "
155162|NCT01535339|"~     Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport.~     Despite ongoing research, there is no highly sensitive clinical test for cognitive function.~     This makes the clinical diagnosis of concussion particularly difficult as the clinical~     presentation of concussion is highly variable with symptoms often evolving over time. Given~     the variability in concussion presentations, there is no single test that can diagnose a~     concussion. Current recommendations are that sports medicine providers apply a multifaceted~     concussion assessment battery that combines subjective symptoms, motor control and cognitive~     assessment.~      This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in~     detecting and managing concussive injuries. This study will establish the reliability of BNA™~     scores over clinically relevant assessment intervals and investigate the effect of SRC and~     sub-concussive head impacts on BNA scores.~   "
155163|NCT01535326|"~     In minimally sedated Asian patients in a community setting the investigators showed that a~     limited volume of water infusion instead of air insufflation in either the rectal sigmoid~     colon or the whole colon significantly reduced pain score during colonoscopy. Cecal~     intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in~     our previous studies.1, 2 In contrast, several US reports described the successful use larger~     volumes of water infused throughout the entire colon in patients undergoing colonoscopy which~     result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review~     suggested that the cause of the difference might lies in the timing of water removal.6~     Specifically, the investigators group removed the infused water predominantly during~     withdrawal phase (water immersion) and the U.S. group removed water during insertion phase~     (water exchange).~      This prospective, randomized controlled trial compared water exchange or water immersion with~     traditional air insufflation in patients undergoing minimally sedated colonoscopy. The~     investigators test the hypothesis that water exchange can reduce more pain than water~     immersion in the investigators clinical setting.~   "
155164|NCT01535313|"~     Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness~     is improved with a powered bone marrow biopsy device in comparison with a manual device.~   "
155165|NCT01535300|"~     The aim of the present study was to evaluate the role of ultrasound in paediatric patients to~     compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse~     tracheal diameter (MTTD) measured by ultrasound and with tube size predicted by different~     age-related formulas.~      The investigators hypothesize that a prediction of pediatric ETT is possible with the~     ultrasonographic measurement of the MTTD.~   "
155166|NCT01535287|"~     The investigators are inviting your child to participate in this research study because your~     child is having myringotomy (putting a tiny incision in the eardrum with or without tube~     insertion) under general anesthesia.~      The purpose of this study is to determine whether a single injection of Dexmedetomidine~     (study medication) decreases the frequency of awaking from anesthesia frightened or agitated~     in children having myringotomy surgery as compared to those children who receive placebo~     (sterile saltwater).~   "
155167|NCT01535274|"~     The seated or beach chair position during surgery and general anesthesia decreases brain~     oxygen levels and can result in stroke. As such, poor neurological outcome following beach~     chair positioning is a growing concern. In the proposed study the investigators test the~     hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral~     oxygenation in anesthetized patients in the beach chair position.~   "
155168|NCT01535261|"~     The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using~     as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema~     secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical~     coherence tomography (OCT) images was analyzed to gain insights into predictive factors for~     disease progression and the possibility of reduced monitoring was assessed in Year 2. The~     results of this open-label study provided long-term safety and efficacy data to further guide~     recommendations on the use of ranibizumab in this indication.~   "
155169|NCT01535248|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopy technique to visualize~     and evaluate the pancreatic and biliary systems. It has been reported that rare instances of~     air embolus have been found associated with the performance of an ERCP and many of these~     events are fatal. It is our proposal to use transthoracic echocardiography to continuously~     evaluate for the presence of intra-cardiac air secondary to ERCP venous air embolism and~     attempt to quantify the incidence of this complication and any potential patient factors that~     might increase the risk of this complication.~   "
168114|NCT01365117|"~     Phase 1 clinical trial to evaluate insulin exposure using different formulations of~     Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.~   "
155170|NCT01535235|"~     The investigators propose a proof-of-concept, pathogenesis-oriented, randomized,~     placebo-controlled pilot study to assess whether the addition of an angiotensin converting~     enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses~     lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune~     responses and an accelerated clearance of the latent reservoir.~   "
155171|NCT01535222|"~     The purpose of this study is to demonstrate that periprocedural infusion of escalating doses~     of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to~     characterize the single dose pharmacokinetics of MDCO-2010, to investigate the effect of~     MDCO-2010 on pharmacodynamics (biomarkers of fibrinolysis and coagulation parameters), and to~     investigate the effect on exploratory clinical endpoints of bleeding, transfusion~     requirements and reexploration.~   "
155172|NCT01535209|"~     Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is~     considered as a standard associated with side effects leading to decreased neurocognitive~     function. The Investigators addressed the question whether stereotactic radiotherapy of the~     resection cavity impairs neurological status and/or cognitive functions in compare to~     adjuvant WBRT.~   "
155173|NCT01535196|"~     The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin substitution~     improve the heart function in chronic heart failure.~      Type of study: Controlled, randomized, double blind, placebo control~      Number of patient: 300; 150 treated and 150 placebo controlled~      Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month~      Duration of study:1+1 year~      Primary end points:~      Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid,~      Secondary end points:~      Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant in~     6 minutes~      Visits:~      Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,~   "
155174|NCT01535183|"~     The outcome of pediatric refractory or relapsed brain tumor is very dismal. Standard~     chemotherapy showed poor response to these patients. Although tandem high dose chemotherapy~     with hematopoietic progenitor stem cell rescues has been chosen as a potentially curative~     therapy for long term survival and better outcome is expected if tumor burden before~     transplantation reduced by chemotherapy, effective salvage chemotherapy for tumor reduction~     is not established yet. Irinotecan is a recently developed topoisomerase I inhibitor, and~     there are preclinical and phase I, II data which proved practical effects in brain tumors. In~     those studies, irinotecan was administered alone or in combination with one other drug.~      Vincristine, etoposide, carboplatin, and cyclophosphamide have been used in many protocols~     for brain tumors but the result was very poor in refractory or relapsed cases. However,~     irinotecan can be effective with these multiple chemotherapeutic agents. According to the~     pilot study of irinotecan in combination with vincristine, etoposide, carboplatin and~     cyclophosphamide in the investigators center, 75% percent of total 12 patients reached more~     than stable disease, and 2 patients got long term complete remission only with this~     multi-agent combination chemotherapy. But the combination of irinotecan, vincristine,~     etoposide, carboplatin, and cyclophosphamide is not clinically studied yet especially for~     pediatric patients. To improve response rate and progression-free survival, the combination~     chemotherapy of irinotecan, vincristine, etoposide, carboplatin, and cyclophosphamide is~     designed for pediatric refractory or relapsed brain tumor.~   "
155175|NCT01535170|"~     Nosocomial infection with antibiotic-resistant strains is a major threat to critical care~     medicine. Selective decontamination of the digestive tract (SDD) is one of the strategies to~     reduce ventilator associated pneumonia and sepsis in critically ill patients. Lactoferrin~     (LF) is a natural multifunctional protein with antimicrobial, anti-tumor, antioxidant, and~     immunomodulatory effects. It has been shown to inhibit the growth of a number of pathogenic~     bacteria including antibiotic-resistant strains, fungi and even viruses in both in vitro and~     in vivo studies.~      In a recent study, the investigators performed pathogen challenges of the digestive tract of~     a transgenic milk-fed animal model. The results showed that recombinant LF has broad spectrum~     antimicrobial activity in the digestive tract and protects the mucosa of the small intestine~     from injury, implying that LF can be used as an effective selective decontaminant of the~     digestive tract.~      This study is a prospective, randomized, double-blind, placebo- controlled clinical trial~     examining whether oral supplementation with bLF can reduce nosocomial infection, sepsis and~     even mortality in patients with prolonged mechanical ventilation (MV). Patients with MV for~     more than 21 days and no signs of infection on admission to our Respiratory Care Center (RCC)~     will be enrolled. They will be randomized to receive either bovine LF (bLF, 10 mg/kg/day) or~     placebo for 6 weeks by center.~      The primary objective is to evaluate the effectiveness of bLF in the prevention of nosocomial~     infection. Secondary objectives are assessment of incidence of nosocomial infection,~     mortality, weaning rate from MV and change of the immune system. The investigators~     hypothesize that bLF may 1) prevent nosocomial infection; 2) reduce mortality; 3)increase~     weaning rate from MV; 4)increase immunity in patients with prolonged MV.~   "
155176|NCT01535157|"~     The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus~     ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In~     addition, researchers would like to determine if the drugs are most effective together or if~     fenretinide (4-HPR/LXS) is most effective alone.~   "
155177|NCT01535144|"~     The purpose of the study is to show the equivalence of a new degradable metallic device to a~     non-degradable metallic device in patients with Hallux Valgus.~   "
155178|NCT01535131|"~     This study compares a standard method for palate repair (the Furlow palatoplasty) with a~     modification of that method to determine which, if either, is more effective in reducing the~     duration of middle-ear disease (fluid in the ear) in cleft palate patients.~   "
155179|NCT01535118|"~     This study will gather information on allergic rhinoconjunctivitis from surveys completed by~     adults and children.~   "
155180|NCT01535105|"~     Obesity is increasing all over the world in adults, adolescents and children,and is followed~     by morbidity, including the metabolic syndrome.~      Hypothesis: Among obese adolescents there is a subgroup with impaired glucose homeostasis~      The aim of the study is to identify adolescents with impaired glucose metabolism, 12-18~     years, among high risk diabetes prone population, for diagnosis and treatment.~   "
155193|NCT01534923|"~     The purpose of this study is to learn more about doctor-patient communication about colon~     cancer screening. This study will also look to see if there are differences in those who get~     colon cancer screening based on the discussion the doctor had with the patient.~   "
155238|NCT01534312|"~     Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent~     colitis and using human in vitro inflammation models. Its use as a food ingredient has proven~     safe and with no influence on dietary intake. We hypothesize that orally administered CGMP~     has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.~   "
155181|NCT01535092|"~     Orthotopic liver transplantation (OLT) is the treatment of choice for patients with Hepatitis~     C Virus (HCV) infection and end-stage liver disease or hepatocellular carcinoma; infection of~     the graft and hepatitis C recurrence is universal after OLT and recurrent HCV hepatitis often~     follows an accelerated course after OLT, with rapid histological recurrence and cirrhosis.~     These very poor outcome significantly affect graft and patient survival and reduces the~     benefit of transplantation for this indication. Therapeutic strategies are not available;~     high viral load, high prevalence of genotype 1b and need of dose reduction of interferon and~     ribavirin because of the side effects or intolerance, together with the interference of~     immunosuppressive drugs, resulted in the vast majority of the patients in failure in~     obtaining viral eradication.~      Recently, Silibinin, has been studied and reported to be capable to act as potent antiviral~     agent in patients with HCV; it has been used successfully in a protocol of a 14 day~     intravenous infusion in previous non-responders to peginterferon/ribavirin therapy. In view~     of his postulated profile of safety, it seems an ideal drug to be used in the setting of HCV~     recurrent patients after liver transplant.~      Aim of this prospective, randomized, double-blind, placebo-controlled, parallel group study~     is to determine the therapeutic effect of Legalon SIL in the prevention of HCV reinfection in~     chronically infected hepatitis C patients after OLT.~      Awaiting orthotopic liver transplantation patients affected by HCV will be randomised 3:1 to~     receive, in addition to their current therapy, silibinin 20mg/kg/day (Legalon SIL) or placebo~     infused over 2 hours from 14 to 21 consecutive days; in addition, patients will receive~     treatment with silibinin 20mg/kg/day (Legalon SIL), infused over 2 hours, for 7 days after~     transplant.~      The Primary Efficacy endpoint is to achieve sustained virological response (SVR) while~     Secondary Efficacy endpoints are to evaluate the virologic response, the percentage of~     patients who has a decreased of at least 2 log10 the levels of HCV-RNA and the safety of~     Legalon SIL in this population.~   "
155182|NCT01535079|"~     Sore throat is one of the most common complaints encountered in clinical practice. And in~     65% of cases, the infection is thought to be viral in nature.~      The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after~     single administration in acute sore throat pain.~   "
155183|NCT01535066|"~     RATIONALE: Acupuncture may help relieve joint pain.~      PURPOSE: This randomized phase III trial studies acupuncture to see how well it works~     compared to sham acupuncture or waitlist in treating patients with joint pain related to~     aromatase inhibitors in patients with early-stage breast cancer.~   "
155184|NCT01535053|"~     This randomized phase III trial studies how well methotrexate works compared to dactinomycin~     in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in~     chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. It is not yet known whether methotrexate is more effective than~     dactinomycin in treating gestational trophoblastic disease.~   "
155185|NCT01535040|"~     RATIONALE: Memantine hydrochloride may help people stop smoking by decreasing the symptoms of~     nicotine withdrawal.~      PURPOSE: This randomized, pilot phase II trial studies how effective memantine hydrochloride~     works compared to placebo in helping cancer survivors stop smoking.~   "
155186|NCT01535027|"~     Increased bone formation in the absence of accelerated resorption is resulting in a marked~     anabolic response to teriparatide (TPTD) during the early phase after treatment initiation.~     Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing~     anabolic effects are accompanied by significantly increased bone resorption as well.~     Antiresorptives influence the balance of bone formation and resorption. Therefore the~     investigators aim is to investigate the effects of the addition of antiresorptives to the~     second half of TPTD cycle when resorption is already also markedly elevated.~   "
155187|NCT01535014|"~     The purpose of this study is:~        -  To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in~          treatment of obese patients.~        -  To assess clinical efficiency of Dietressa in the dose of 6 tablets daily within 24~          weeks of therapy in reducing body weight in obese patients.~        -  To compare clinical efficiency of two dosage patterns for Dietressa (1 tablet 6 times~          daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.~   "
155188|NCT01535001|"~     The purpose of this study is to test whether an algorithm for systematic non-surgical~     treatment consisting of corrective insoles, neuromuscular training, weight loss, patient~     education and pharmacological treatment with paracetamol, non steroidal anti inflammatory~     drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of~     life than standard non-surgical treatment (information on the disease and how to treat it) in~     patients with knee osteoarthritis.~      The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of~     life and functional capacity and greater reduction in pain than standard treatment at the~     primary endpoint, which is follow-up 12months after the start of the treatment.~      See statistical analysis plan available under Links for further description of the study.~   "
155189|NCT01534975|"~     The purpose of this study is to compare the effects of a certain contrast agent (iodixanol)~     to two other commonly used contrast agents called Iopamidol (Isovue) and iohexol (Omnipaque),~     on heart and kidney safety in patients undergoing a cardiac CT angiogram. The investigators~     will evaluate whether iodixanol 320 (Visipaque®), an iso-osmolar agent, is better tolerated~     (flushing, injection site pain/warmth, headache, nausea) and provides equal image quality~     compared with iohexol 350 (Omnipaque®) and Isovue 370 during 64-slice multidetector computed~     tomography angiography (MDCTA). A fourth group (Visipaque 270) will be included, using low~     radiation dose technology during acquisition, to evaluate image quality, tolerability, and~     contrast enhancement compared to both Visipaque 320 and Omnipaque and Isovue. In addition to~     image quality, tolerability, and contrast enhancement, the investigators will evaluate heart~     rate, adverse events, reimaging, costs, and patient satisfaction among all four cohorts.~      The study will recruit 400 participants already undergoing CT angiography and consent and~     randomize them to one of four groups. Each of the possible contrast agents used are commonly~     used for CT angiography, so the primary risk is loss of confidentiality and being asked~     questions about tolerability. All other facets of the study (3 lead ECG, beta blockade,~     nitroglycerine use, CT angiography and contrast administration) are standard of care and~     being done for clinical uses.~   "
155190|NCT01534962|"~     Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low,~     intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful~     electrical cardioversion in patients with persistent atrial fibrillation (AFib).~      After successful cardioversion and subsequent randomisation, patients report trans-telephonic~     EGCs on a daily basis to a central core ECG facility.~      Maximum treatment duration is 112 days (16 weeks).~   "
155191|NCT01534949|"~     This study is designed to provide initial evidence of safety, pharmacokinetics,~     pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial.~   "
155194|NCT01534910|"~     The investigators will be assessing the effect of Aged Garlic Extract on the coronary~     arteries. The investigators will enroll patients in a double blind study, where half the~     patients will receive placebo, and have the patients undergo a series of tests of plaque (CT~     scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and~     then repeat the tests and blood work at the end of one year. The investigators will assess if~     being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries. The~     investigators will also assess the effect of aged garlic extract on markers of inflammation.~     Patients will receive free drug, free testing and be compensated, and learn more about their~     heart and neck arteries. if successful, more patients can use this drug to benefit their~     health. The harms include the radiation from the CT scan and the medication, which has mild~     side effects.~   "
155195|NCT01534897|"~     Radioactive iodine therapy is often part of the standard treatment for Papillary Thyroid~     Carcinoma (PTC) patients. However, in many patients, tumors develop a resistance or no longer~     respond to radioactive iodine therapy (iodine-refractory). Several lines of evidence suggest~     that blocking the BRAF gene may help to re-sensitize the tumors to radioactive iodine. BRAF~     is a protein that plays a central role in the growth and survival of cancer cells in some~     types of PTC. The investigational drug GSK2118436 may work by blocking the BRAF protein in~     cancer cells lines and tumors that have a mutated BRAF gene.~      In this research study, the investigators are looking to see if GSK2118436 can re-sensitize~     iodine-refractory PTC to radioactive iodine therapy. The investigators are also looking at~     the safety of adding GSK2118436 to radioactive iodine therapy.~   "
155196|NCT01534884|"~     This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective,~     Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last~     and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA~     concomitantly treated with MTX during the Core Study Period.~   "
155197|NCT01534871|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects approximately 1% of~     all Canadians. RA is associated with a higher rate of disease and death as well as a~     decreased life expectancy. Changes in death rates and life expectancy are mainly the result~     of an increased frequency of cardiovascular disease (CVD). The increase in CVD frequency is~     primarily attributable to accelerated atherosclerosis. It is believed that elevated levels of~     inflammation, which are characteristic of RA, play a key role in accelerated rate of CVD in~     RA patients. Thus, inflammation is considered a primary risk factor for CVD in RA patients.~     Interestingly, despite a better understanding of the relationship between RA and CVD and~     improved treatment for RA patients the death rate in RA population continues to increase.~     Thus, there is an immediate need to develop treatment strategies to reduce the risk of CVD~     associated with inflammation in the RA population.~      Exercise is commonly used to reduce the risk of CVD. Preventative exercise programs are often~     offered as part of cardiac rehabilitation (CR) programs. These programs help patients modify~     CVD risk factors, improve physical capacity and decrease CVD risk. Studies also suggest that~     CR programs decrease levels of inflammation. Since RA patients have an elevated risk for CVD,~     which is primarily attributed to increased levels of inflammation, they are prime candidates~     for CR programs. However, RA patients are very rarely referred to CR programs. Thus, there is~     a lack of information regarding the effects of CR on RA patients. Thus studies are needed to~     determine whether CR modifies levels of inflammation and decreases CVD risk in RA patients.~     Therefore, the purpose of this study is to determine the effects of a 12-week standardized~     cardiac rehabilitation exercise program on systemic inflammation and CVD risk in individuals~     with RA. Specifically, this study will characterize the effects of a community based CR~     exercise program on systemic markers of inflammation (proinflammatory cytokines) and global~     CVD risk (Framingham risk profile) as well as the therapeutic effects of CR exercise on the~     severity of RA.~      This study will help to clarify the mechanism(s) by which exercise impacts CVD risk in~     patients with inflammatory disease. In addition, the study will show how CR may benefit~     patients with inflammatory disease with respect to their ability to exercise, global risk for~     cardiovascular disease and quality of life.~   "
155198|NCT01534858|"~     The purpose of this study is to evaluate the healing of split thickness skin grafts when~     treated with Prontosan® Wound Gel X in patients with partial and full thickness skin burns.~   "
155199|NCT01534845|"~     1. The management of anaplastic gliomas of WHO grade 3 is currently largely based on~          surgery followed by radiotherapy, of which prognosis remains still dismal with the~          median survival of 2-5 years. To date, the benefit of chemo for WHO grade 3 gliomas is~          unclear of modest at best with conventional cytotoxic agents, and the role of~          temozolomide for these entities still is not elucidated.~        2. Codeletion of chromosome 1p/19q is considered the most important marker of prognostic~          significance in WHO grade 3 gliomas.~        3. To project a randomized phase 2 screening trial examining the efficacy of concurrent~          chemoradiotherapy with temozolomide followed by adjuvant temozolomide for WHO grade 3~          gliomas without codeletion of chromosome 1p/19q.~        4. The prognostic significance of methylation status of MGMT and IDH1 mutation as molecular~          markers will be also assessed in each arm as key secondary analysis.~   "
155200|NCT01534832|"~     The study will examine the safety and performance of a new surgical smoke clearance system~     designed for use during laparoscopic surgery.~   "
155201|NCT01534819|"~     Subjects who meet inclusion/exclusion criteria and who are treated with the Aptus Heli-FX~     EndoAnchor System in conjunction with commercially available non-Aptus Endografts will be~     divided, as appropriate, into two groups.~        1. Primary Group- Subjects undergoing initial (primary) endovascular repair of an AAA where~          the investigator believes the proximal aortic neck is challenging such that the risk of~          failure or fixation and/or sealing is great enough so that the use of the Heli-FX~          EndoAnchor System is warranted.~        2. Revision Group- Those subjects who have previously undergone an EVAR procedure where the~          investigator believes that use of the Heli-FX EndoAnchor System is warranted to A- Treat~          existing graft migration and/or type 1a endoleak, with or without the concurrent use of~          other devices. B- Treat subjects believed to be at risk for migration and/or Type 1a~          endoleak~      Subjects must sign an ICF prior to obtaining any study specific information. Subjects are~     eligible to be consented up to 30 days post-procedure.~      Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post~     procedure. Study recommended follow-up is per SVS and ESVS guidance.~   "
155202|NCT01534806|"~     The aim of this study is to evaluate whether the use of prochlorperazine and ketorolac in~     combination lead in a larger reduction in pain score compared to prochlorperazine alone when~     treating pediatric migraine in the Emergency Department (ED). Our hypothesis is that this~     combination of medications treats not only the pain but also the associated gastrointestinal~     symptoms of migraine. The main outcome of this study is the reduction in the patient's pain~     score at 60 minutes from administration of the study medications. Secondary outcomes include~     the number of patients achieving complete resolution of the headache while in the ED, the~     number of patients requiring additional treatment interventions by the treating physician,~     the number of patients with resolution of the associated symptoms like nausea, vomiting,~     photophobia and phonophobia, the recurrence of headache in the 48-72 hours after discharge,~     and side effects of the medications.~   "
155204|NCT01534780|"~     Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7~     cm, laparoscopic surgery with intraperitoneal onlay mesh.~      Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with~     either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd~     postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1,~     6, 12, 24, 36, 48 and 60 months postoperative.~   "
155205|NCT01534754|"~     This is a multi-centre, randomised, double blind, double-dummy, parallel groups,~     placebo-controlled trial was conducted in a population of patients suffering from symptomatic~     uncomplicated diverticular disease in order to investigate which is the best treatment in~     preventing relapses of the disease.~      Patients were randomly divided in double-blind fashion in one of the following groups:~      Group A. Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei~     placebo, 1 sachet/day for 10 days/month;~      Group B. Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800~     placebo, 2 tablets/day for 10 days/month;~      Group C. Active mesalazine 800 ng, 2 tablets/day plus Active Lactobacillus casei, 1~     sachet/day for 10 days/month;~      Group D. Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1~     sachet/day for 10 days/month.~      The main objective was to assess the safety and the efficacy of mesalazine and/or~     Lactobacillus casei in maintaining remission of symptomatic uncomplicated diverticular~     disease~   "
155206|NCT01534741|"~     Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied~     Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic~     hemodialysis patients Treatment: Each patient will be treated by post-dilution online~     hemodiafiltration once with each dialyzer type.~      Study objectives: Intraindividual comparison of removal rate of urea, phosphate,~     ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and~     alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during~     post-dilution online hemodiafiltration.~      Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea,~     phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and~     alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects~   "
155207|NCT01534728|"~     Nearly 175 million people worldwide are infected by Hepatitis C Virus (HCV), close to 3% of~     the global population. Contrary to other chronic infections such as HIV, clearance of HCV is~     possible. While much is now known about the response to treatment in chronic HCV patients,~     the fact that acute HCV infection is typically asymptomatic (~80% of patients show no~     clinical signs) has made it challenging to define the mechanisms involved in spontaneous~     clearance.~      Immune protection against HCV is thought to be largely dependent upon the CD8 T cell~     response. Therefore using the latest T cell detection technology the investigators will~     develop a panel of tetramers specific for all potential HCV epitopes. To produce the~     tetramers the investigators will utilize HLA ligand exchange technology which allows the~     production of very large collections of peptide-HLA multimers for T cell staining. The~     investigators have already performed a large scale identification of HCVg1 and HCVg4 CD8 T~     cell epitopes using published viral sequences and algorithm prediction databases. Using this~     information the investigators are currently in the process of developing collections of~     peptide-HLA multimers for T cell staining. Therefore the investigators require large~     lymphocyte pools from HCV+ patients to test both the sensitivity and accuracy of each~     tetramer on the CD3+CD8+ T cells.~      The investigators wish to examine cells from patients infected with HCV g1 and HCV g4 to be~     able to test and compare the frequency of possible conserved epitopes present in both HCVg1~     and HCVg4 infections. Once developed this technique will allow us to examine all~     virus-specific CD8 T cells present in patients with acute or chronic disease, and on smaller~     quantities of blood. The development of these technologies will also allow us to tailor such~     future diagnostic tests to local populations where a viral subspecies is prevalent; for~     example using North-African HLA alleles for HCVg4 epitopes.~      The work carried out using such assays will provide important immunological correlates of~     viral clearance that will impact vaccine design for HCV infections. Finally, the~     identification of protective CD8 T cells specific for HCV may allow new diagnostic tools with~     predictive powers of disease progression that can be used on any flow cytometer machine.~   "
155208|NCT01534715|"~     The purpose of this study is to test the safety and tolerability of IMGN529 in patients with~     relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).~   "
155209|NCT01534702|"~     With current chemotherapy protocols, in 60-80% of patients with acute myeloid leukemia (AML)~     the leukemic blasts in the bone marrow can be reduced to < 5%. This is called complete~     remission (CR) and is the prerequisite for cure of the disease. During the last years,~     several genetic and biologic risk factors for the achievement of CR have been defined, and~     the remission rates vary considerably between patient groups with different risk profiles. On~     one hand, patients with certain chromosomal or molecular aberrations have very high CR rates~     of approximately 90%. Moreover, in some of these patients, molecularly targeted therapies for~     specific genetic aberrations are currently evaluated in clinical trials. However, these~     genetic aberrations account for only 50-60% of the overall patient population in AML. The~     remaining patients have a significantly inferior CR rate of only 50-60% with 30% resistant~     disease after two cycles of standard induction chemotherapy. In conclusion, there is need for~     improved induction regimens in a large number of adult patients with AML. An improved CR rate~     in this patient population will increase the number of patients eligible for intensive~     consolidation such as an allogeneic stem cell transplantation and might thereby be the basis~     for a better overall outcome. However, there is no clear evidence that this goal can be~     achieved with the currently available chemotherapy protocols. Clofarabine~     (2-chloro-2-fluoro-deoxy-9-D-arabinofuranosyladenine) is a nucleoside analogon which combines~     properties of fludarabine and cladribine. Due to the lack of neurological side effects,~     clofarabine could be explored in higher doses than other nucleoside analogues and has shown~     considerable antileukemic activity in patients with relapsed or refractory acute leukemias~     and elderly AML patients alone or in combination with cytarabine. In addition, the~     combination of clofarabine, cytarabine and idarubicin has produced promising results with~     acceptable toxicity in patients with relapsed or refractory AML. Based on these initial~     studies, there is need for a further optimization of the clofarabine dose in this~     combination. The aim of the AMLSG 17-10 study is therefore to evaluate the tolerability and~     safety of increasing doses of clofarabine in combination with idarubicin/cytarabine in~     patients with high risk AML defined by the genetic and molecular risk profile.~   "
155210|NCT01534689|"~     The purpose of this study is to determine whether low level laser light is effective in the~     treatment of toenail fungus.~   "
155211|NCT01534676|"~     The purpose of this study is to determine the effects of transfusion of fresh and stored~     blood on patients.~      The investigators hope to test:~        -  whether a similar effect (older stored blood is associated with worse outcomes) is seen~          in chronically transfused patients with hemoglobinopathies. This patient population will~          also allow the investigators to test whether iron- chelation therapy is beneficial in~          this setting.~        -  whether washing or cryopreserving the red blood cells has any effect on this outcome.~      These findings may explain the immunomodulatory effects of older stored blood in patients and~     will help us develop safer transfusion products for patients.~   "
155239|NCT01534299|"~     This is a prospective, multi-center, single-arm, non-interventional and open-label registry.~     The purpose of the registry is to document the long-term safety and effectiveness of renal~     denervation in a real world patient population with hypertension and gathering data for other~     diseases characterized by elevated sympathetic drive, such as diabetes mellitus type 2, renal~     insufficiency, etc. The Global Symplicity Registry will consecutively enroll 3000 patients~     who undergo the renal denervation procedure, from over 200 sites worldwide.~   "
191554|NCT01057043|"~     The purpose of this exploratory randomised trial is to study the effect of pulsatile cupping~     in osteoarthritis of the knee compared to waiting list control.~   "
155212|NCT01534663|"~     The aim of this study is to determine whether supplementation of glutamine and fish oil can~     improve peripheral skeletal muscle function and metabolism in patients with heart failure.~     The investigators propose a randomized, double-blind, placebo controlled study comparing the~     combined supplementation of fish oil and glutamine with placebo in patients with stable heart~     failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish~     oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this~     study is the change in muscle functional capacity measured as changes in maximum muscle~     strength and fatigability, peak VO2 and exercise time after supplementation. A secondary~     outcome is the measurement of systemic and local markers of inflammation.~   "
155213|NCT01534650|"~     The purpose of this study is to collect kinematic motion data from subjects with movement~     disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate~     algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements),~     dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks~     and/or activities of daily living.~   "
155214|NCT01534637|"~     This pilot clinical trial is studying how well aprepitant works in preventing nausea and~     vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer.~     Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in~     patients receiving chemotherapy and radiation therapy~   "
155215|NCT01534624|"~     Background:~      - Researchers are interested in studying the roles that genes play in drug and alcohol~     addiction. Genes seem to account for about half of the differences between people who become~     addicted to drugs and people who do not. This study will collect blood and skin cell samples.~     These cells will be used to develop stem cells that are useful for studying how genes are~     related to drug use and dependence.~      Objectives:~      - To study genetic and cellular differences between people who are addicted to drugs and~     those who are not.~      Eligibility:~        -  Individuals between 21 and 65 years of age who do not use drugs.~        -  Individuals between 21 and 65 years of age who are in treatment with buprenorphine or~          methadone.~      Design:~        -  Participants will be screened with a brief physical exam and medical history.~        -  Participants will also answer questions about physical and mental health, quality of~          life, and history of drug and alcohol use. A urine sample and cheek swab sample will be~          collected.~        -  Participants whose genetic samples match the study requirements will be asked to come~          back to provide a skin biopsy sample and a second urine sample.~   "
155216|NCT01534598|"~     Background:~      - FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are~     experimental cancer treatment drugs. FdCyd may change how genes work in cancer cells. THU~     helps keep FdCyd from being broken down by the body. FdCyd and THU have been given to people~     on other cancer treatment trials, usually by vein. Researchers want to give FdCyd and THU by~     mouth to see if they work against cancers that have not responded to earlier treatments.~      Objectives:~      - To test oral FdCyd and THU on advanced solid tumors that have not responded to earlier~     treatments.~      Eligibility:~      - Individuals at least 18 years of age who have advanced solid tumors that have not responded~     to standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and tumor samples will used to study the~          cancer before treatment.~        -  FdCyd and THU will be given in 21-day cycles. THU should be taken 30 minutes before~          taking FdCyd.~        -  Participants will take FdCyd and THU by mouth, once a day, for 3 days at the beginning~          of the first and second weeks of each cycle (days 1 3 and 8 10). The drugs will not be~          taken during the entire third week of each cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Treatment will continue as long as the cancer is responding to the drugs and serious~          side effects do not develop.~   "
155217|NCT01534585|"~     Nasopharyngeal carcinoma (NPC) is a prevalent disease in southeast of China. Radiation~     therapy with or without chemotherapy is a standard therapy for nasopharyngeal cancer.~     Cytotoxic chemotherapy plays an important role in the curative treatment of advanced NPC.~     However, concurrent chemoradiotherapy increased significantly local and systemic toxic~     effects, which may preclude many patients from proceeding with combined therapy. The~     epidermal growth factor receptor(EGFR) gene is amplified in 40% and EGFR protein is~     overexpressed in over 80% of NPC. EGFR overexpression is also associated with shorter~     survival following chemoradiotherapy in locoregionally advanced NPC. And some basic~     researches have proved that EGFR tyrosine kinase inhibitors(TKIs) could increase the~     radiosensitivity and reduce the epithelial-mesenchymal transition (EMT) in NPC cell line.~     Moreover, distant metastases has been the major cause of treatment failure in NPC. Icotinib~     hydrochloride is a novel oral EGFR TKIs with low mammalian toxicity(made in China). But base~     on toxic effects of Icotinib, it may increase toxic effects about skin and mucosa in~     combination therapy with Icotinib and Intensity-modulated Radiotherapy (IMRT). The~     prospective study will assess the tolerability and efficacy of Icotinib combined with IMRT in~     patients with NPC. This regimen is of great interest and it has potential to alleviate the~     adverse effects, improve patient compliance and better therapeutic ratio.~   "
155218|NCT01534572|"~     There is a constant exchange between the gut epithelium and lumen, including microbial~     interplay. The aim of this study was to investigate dietary test products on inflammatory~     proliferation markers in the gut, and thereby if the products had positive effects in the gut~     as well as in other parts of the body.~      The hypothesis was that the test products would reduce the inflammatory and proliferation~     activity of the gut epithelium by fermentation of normal food products and by converting~     dietary phenolic compounds into anti-inflammatory substances.~   "
155240|NCT01534286|"~     The purpose of this study will be to show the patient response to analgesics taken post~     surgery when taken in combination with Theramine as opposed to Theramine-like placebo. The~     data collected will be used to show that patients have a shorter and lower post operative~     pain measurement and the time to discontinuation of analgesics is less in the active~     comparator group.~   "
155241|NCT01534273|"~     The purpose of this phase I study in healthy participants will be to evaluate the safety and~     tolerability of LY2886721 single and multiple doses, how the body handles the drug and the~     drug's effect on the body.~   "
169850|NCT01342354|"~     This purpose of this study is to determine the highest tolerated dose of Stereotactic Body~     Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic~     cancer.~   "
155219|NCT01534559|"~     It widely accepted that a number of medication related problems can occur after the patient~     has been discharged from the hospital. An obvious extension of the ongoing integrated~     medicines management programme (IMMP) is therefore to provide a medicines management clinic~     within an outpatient setting as well as follow-up telephone calls from a clinical pharmacist.~     This study aims to assess the influence a pharmacist-led medicines management outpatient~     service on patients at high risk of medication related problems.~      It is anticipated that this service will~        -  Ensure continuity of pharmaceutical care for patients post discharge.~        -  Reinforce patient education in order to improve knowledge and understanding of the~          medication prescribed.~        -  Ensure that both prescription medicines and OTC preparations are used appropriately.~        -  Facilitate the communication with other members of healthcare team in order to agree and~          implement measures to overcome medication related problems.~   "
155220|NCT01534546|"~     Peri-operative treatment of locally advanced gastric cancer (LAGC) has always been argued by~     eastern and western scholars. For patients with clinical stage of cT4b/N+M0, or cT4aN+M0, the~     prognosis is rather poor, and the primary lesions might not be resectable at the time of~     diagnosis. MAGIC study has showed that pre-and post-operative chemotherapy with 3 cycles of~     ECF has increased 13% on 5yOS compared with surgery alone; However, eastern studies such as~     ACTS GC or CLASSIC showed that TS-1 monotherapy or XELOX (oxaliplatin/capecitabine)~     combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery~     could achieve the significant survival benefit. So whether perioperative or post operative~     therapy is more beneficial for LAGC patients lacks of data supported by prospective study.~      So in this prospective randomized phase III study, the investigators aim to compare the~     survival benefit as well as the safety for SOX (oxaliplatin/TS-1) as perioperative therapy~     versus SOX or XELOX as postoperative therapy after D2 dissection.~   "
155221|NCT01534533|"~     This study is to investigate the possible positive effects of lutein and lycopene~     supplementation on early atherosclerosis in Beijing.~   "
155222|NCT01534520|"~     This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is~     effective at decreasing pain during intrauterine device insertion in nulliparous women.~   "
155223|NCT01534507|"~     Irritable bowel syndrome, (IBS) is a common functional disorder of the gut that can be quite~     disabling to patients. The most common symptoms of IBS are abdominal pain or discomfort along~     with erratic changes in bowel habit of diarrhoea, constipation or a mixture of the two~     (referred to as IBS subtypes). Despite much research efforts to further understand the~     pathophysiology of IBS; as yet no specific biomarkers/definitive measurements have been~     identified that can be use to aid the diagnosis and reduce the need for unnecessary,~     unpleasant and expensive tests.~      Evidence shows that anxiety plays a part in IBS and can speed up transit time in the small~     bowel. In this study, the investigators hypothesise that since anxiety is a common feature of~     IBS, then fast small bowel transit is likely to be found in all subtypes of IBS and the~     difference in stool frequency and consistency in IBS subgroups are therefore likely to~     reflect differences in colonic function. The investigator wish to test this by measuring both~     small and large bowel transit times using Magnetic Resonance Imaging (MRI) and validate the~     results of the MRI with two methods currently used in clinical practice -The previously~     validated lactose-C13 Ureide breath test (for small bowel transit) and the standard~     radio-opaque pellet method to assess the whole gut transit (WGT) time.~   "
155224|NCT01534494|"~     This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin~     in alcohol dependent participants, demonstrate the feasibility of the integrated~     behavioral/pharmacologic intervention, and provide preliminary outcome and safety data.~     Participants will receive psilocybin orally in two all-day administration sessions, conducted~     in a secure outpatient psychiatric setting, in a dose range that has been well-tolerated in~     recent studies. Psilocybin administration will occur in the context of a behavioral~     intervention including a total of 12 sessions over 12 weeks, incorporating Motivational~     Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on Motivational~     Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as preparation before~     and debriefing after the psilocybin administration sessions. The MET will incorporate~     attention to spirituality as well as drinking behavior as a primary subject of change.~     Drinking outcomes and changes in several potential mediators of treatment effect, including~     motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the~     experience, will be measured during treatment and for 24 weeks after the end of treatment.~     The investigators hypothesize that drinking will decrease following the psilocybin sessions,~     and that increases in motivation, self-efficacy, and spirituality (primary contrast 12 weeks~     vs. baseline) will be observed among study participants.~   "
155225|NCT01534481|"~     The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26~     months of donor human milk as compared to preterm infant formula as the in-hospital diet for~     infants whose mothers choose not to provide breast milk or are able to provide only a minimal~     amount. Infants will be randomized to receive donor breast milk or formula during their~     hospital stay. Infant's will be followed until they reach 22-26 months of age.~   "
155226|NCT01534468|"~     H7N7 is one type of influenza virus that may pose a threat to humans if an outbreak occurs.~     This study will evaluate the safety and immune response to an H7N7 vaccine in people who have~     previously received a live attenuated influenza vaccine (LAIV) as part of a research study~     and people who have not previously received a LAIV.~   "
155242|NCT01534260|"~     This research is being done because treatment options are very limited and usually~     unsuccessful for Acute Myeloid Leukemia (AML) in older individuals, or younger people with~     disease that has relapsed and/or proven resistant to standard therapy. Subjects are invited~     to participate in this study that will examine the use of three drugs called Sorafenib~     (Nexavar), Vorinostat (Zolinza) and Bortezomib (Velcade) for treating acute myeloid leukemia.~   "
155243|NCT01534247|"~     The purpose of the study is to assess whether there is any pharmacokinetic interactions~     between CAZ-AVI and metronidazole.~   "
155254|NCT01534091|"~     The purpose of this study is to examine if internet supervised by pedometer will contribute~     to enhance the amount of physical activity at leisure time by obese children.~      The investigators hypothesize that using pedometer will increase the amount of physical~     activity done by obese children in the afternoon and will improve the likelihood of success~     in the intervention program.~   "
155227|NCT01534455|"~     -  Lapatinib in combination with capecitabine has been approved for the treatment of women~          with HER-2-positive advanced breast cancer that have progressed after anthracycline-,~          taxane-, and trastuzumab-containing therapies. The use of this combination is limited by~          overlapping toxicity such as diarrhea and cutaneous side effects.~        -  A significant number of patients receive today capecitabine with trastuzumab as first-~          or second-line treatment. Therefore, other combinations of lapatinib with less toxic~          cytotoxic agents are needed.~        -  Eribulin mesylate (E7389) is a synthetic analog of Halichondrin B (HalB), a large~          polyether macrolide isolated from a marine sponge. Eribulin is a mechanistically unique~          antagonist of microtubule dynamics among tubulin-targeted agents, leading to inhibition~          of microtubule growth in the absence of effects on microtubule shortening, and formation~          of non- productive tubulin aggregates.~        -  Eribulin mesylate at a dose of 1.4 mg/m² given on day 1, 8 every 3 weeks has shown~          better overall survival by 2.5 months compared to treatment of physicians choice in~          patients with locally advanced or metastatic breast cancer who were previously treated~          for 2-5 lines with anthracyclines, taxanes, and capecitabine (EMBRACE study).~        -  The most frequently reported eribulin-related AEs were asthenia/fatigue (65%), alopecia~          (60%), neutropenia (60%), nausea (44%), anemia (28%), pyrexia (23%), leucopenia (22%),~          anorexia (21%), constipation (19%), vomiting (18%), and peripheral neuropathy (5.5%;~          only grade 3). Grade 4 neutropenia occurred in 32% of patients, and febrile neutropenia~          occurred in 5.5% of patients. The frequency of all other grade 3/4 AEs was less than 3%.~          This toxicity profile does not overlap with that of lapatinib.~        -  There is uncertainty in how far a once every 3 week schedule of eribulin mesylate at a~          dose of 2.0 mg/m² would be better tolerated. Several phase II studies are currently~          conducted in various non-breast cancer indications to compare the d1+8 q d21 with a d1 q~          d21 schedule.~        -  The aim of this randomized phase II study is to compare the efficacy and tolerability of~          two dose-schedules of eribulin plus lapatinib in HER2-positive breast cancer,~          pre-treated with trastuzumab in the adjuvant and/or metastatic setting.~   "
155228|NCT01534442|"~     The aim of this study is to investigate the role of transmission of vagal cholinerg for the~     GLP-1 potentiation of the glucose stimulated insulin secretion and the cephalic insulin~     response by using atropin administration.~      The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous~     system and for this reason the investigators will research individuals with an intact nervous~     supply with and without atropin administration.~   "
155229|NCT01534429|"~     Increasing experience has identified post-herniorraphy chronic pain as an under-recognized~     and important complication. Nerve entrapment and injury are recognized as causes of such~     pain. Operative treatment for selected patients with this condition includes surgical~     exploration of the affected groin, identification and removal of involved nerves, and removal~     of meshoma. This procedure has been highly effective in treatment of chronic pain. This study~     will attempt to subjectively and objectively evaluate the patient's chronic groin pain using~     quantitative sensory testing (QST) and validated pain scales and questionnaires. Quantitative~     sensory testing is a method used to assess damage to the small and large nerve fibers. It is~     used to diagnose and assess the severity of nerve damage, and can also help to determine if a~     neuropathy is responding to treatment. QST uses a computer testing system to measure how~     nerves react to vibration and changes in temperature. The procedure is non-invasive and the~     patient will feel minimal to no discomfort during testing. The hypothesis is that any~     decrease in subjective pain scores would be accompanied by improved QST results.~   "
155230|NCT01534416|"~     The purpose of this study is to determine the effectiveness of placing numbing medication~     around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain~     after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted~     myomectomies. It will assess whether patients who receive the medication experience less pain~     and require less pain medication post operatively and if it helps reduce the number of~     patients who require hospitalization for pain control following surgery.~   "
155231|NCT01534403|"~     The study is an open-labeled extension study to continue to assess the safety and~     tolerability of Epratuzumab in moderate to severe SLE subjects who have previously~     participated in SL0026 [NCT01449071] phase I/II trial.~   "
155232|NCT01534390|"~     Studies showed that infusion or injection of drugs and fluids results in introduction of~     microparticles into the bloodstream. These microparticles may cause organ damage and~     stimulate the immune system thus aggravating the underlying disease. Given that critically~     ill patients are characteristically suffering from a high disease severity and receive large~     amounts of fluids and drugs, they may be at particular risk of harm by these microparticles.~     In-line microfilters have been shown to clear microparticles from intravenous drugs and~     solutions. The investigators hypothesize that use of in-line microfilters reduce the days~     with the systemic inflammatory response syndrome in adult critically ill patients.~   "
155233|NCT01534377|"~     This study will evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A)~     for the treatment of depression and prevention of depression in maltreated and nonmaltreated~     girls between the ages of 13-15 years old.~   "
155234|NCT01534364|"~     The aim of this study is to assess the effect of a diet prior to cardiac surgery on the~     common postoperative decline of renal function. Until now, there is no known drug or~     procedure to preserve the kidneys from this impairment. Patients with a known kidney disease~     are especially at risk. A potential beneficial effect of a diet prior to surgery has been~     shown in investigations in mammals, therefore this study will investigate if a preoperative~     diet in patients with known kidney disease and scheduled heart surgery can attenuate or~     prevent a postoperative loss of kidney function.~   "
155235|NCT01534351|"~     This study is designed to compare safety and efficacy of monotherapy finasteride to~     combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic~     hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that~     concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to~     BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from~     baseline on the International Prostate Symptoms Score (IPSS) and will be superior with~     respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as~     measured by percent change from baseline in prostate volume.~   "
155236|NCT01534338|"~     The primary aim of the study is to test the effect of mindfulness training on sleep~     parameters among older adults with insomnia symptoms~      The secondary aims are to examine if changes in mindfulness meditation practice (daily log)~     and level of mindfulness (self-report) are associated with changes in sleep parameters, and~     to determine if mindfulness training is associated with in vitro biological markers of~     peripheral inflammation~   "
155237|NCT01534325|"~     The purpose of this study is to determine whether the SD unique device is effective in~     treatment of overweight and obesity.~   "
155271|NCT01533870|"~     Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics of~     NKTR-118.~   "
155272|NCT01533857|"~     This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose~     to healthy males.~   "
155244|NCT01534234|"~     The objective of this study is to assess the safety and effectiveness of the automatic~     atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in~     the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device~     (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of~     the atrial pacing lead, and compatible SmartView programming software.~      This study will evaluate the effectiveness of the automatic optimization algorithm in~     increasing the rate of patients responding to the therapy as compared to an echocardiographic~     optimization method.~      This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.~   "
155245|NCT01534221|"~     The superiority of a percutaneous coronary intervention (PCI) by one stent over another in~     terms of clinical outcome is usually documented in large randomized controlled trials (RCT).~     Although generated from selected study populations these data form the basis for evidence~     based practice (EBP) in the entire population of patients considered for coronary~     intervention. An inherent limitation of this approach is that study populations differ~     significantly from all comers in terms of patient characteristics and prognosis undermining~     the foundation for extrapolation of trial results to all comers. Furthermore, other trials~     are based on a one-fits-all concept, while the benefits of an individual-tailored~     approach that might be superior, is not investigated.~      The Purpose of the current study is to~        -  Compare clinical outcome between several CE marked drug eluting stents~        -  Compare clinical outcome between several CE marked bare metal stents~        -  Compare clinical outcome in all comers with that of the selected study population of~          RCT's~        -  Evolve methods to compare clinical outcomes between the generalized one-fits-all~          versus the individualized or individual-tailored stent selection approaches~      The Method employed is~        -  All comer PCI registry - single centre~        -  Randomisation of all eligible patients within the registry to one of several study stent~        -  Quality assurance in non-randomized population within the registry by periodical~          alternating the institutional standard stent~        -  Continuous follow up of all patients included the registry by means of systematic event~          detection and classification by an independent safety and end point committee~        -  Assessment of effects on quality of life by heart and health questionnaires~      Outcome Measures~      Primary endpoints:~        -  Composite of cardiac death, acute myocardial infraction and target vessel~          revascularisation~        -  Stent thrombosis~        -  A specifically developed Treatment Failure Rate classification~      Secondary outcome measures include each of the above, target lesion revascularisation and~     total death analyzed in a hierarchical fashion at 2, 3, 4 and 5 years.~      Tertiary outcome measure is self reported quality of life based on health questionnaires on~     general health and cardiac symptoms.~      Power Calculations An event rate of 20% within 5 years, a relative difference of 25% (an~     absolute difference of 5%), P< 5%, Power > 80% => 900 patients in each of two treatment arms.~      Prespecified Analysis include~        1. The MACE rates between stent types~        2. The Stent thrombosis rates between stent types~        3. The Treatment failure rates between stent types~        4. The randomized population versus non-randomized population~        5. The individualized versus the generalized Population~        6. QOL between stent types~   "
155246|NCT01534208|"~     ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men~     with secondary hypogonadism.~   "
155247|NCT01534195|"~     The purpose of this study is to evaluate the effectiveness of the modified Conjunctival~     Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to~     treatment with a proven ocular anti-inflammatory medication,~      Prednisolone, assessed by the following measures:~        -  Ocular itching~        -  Conjunctival redness~   "
155248|NCT01534182|"~     A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient~     Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing~     Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease~     Modifying Therapy.~   "
155249|NCT01534169|"~     Antithyroid drugs is the first choice treatment of Graves' disease in China and Europe.~     However,the relapse rate is very high (40-60%) after therapy withdrawal, and many patients~     need further treatment. In our previous study, a new treatment strategy for GD has been~     introduced. After methimazole (18 months) combined with intrathyroid injection of~     dexamethasone (DEX) (3 months) treatment, the relapse rate of hyperthyroidism was markedly~     reduced compared with methimazole treatment alone (7.4% versus 51%) during the 2-year~     follow-up period. The results have been published in the 'J Clin Endocrinol Metab,~     2009,94:4984-4991'. However, the mechanism by which the DEX reduces the relapse rate of GD is~     not fully understood. In vitro study, we have proven that DEX could effectively improve the~     function of regulatory T (Treg) cells and set up a new balance of T helper 1(Th1)/Th2 in GD~     patients(this results have been in press in the Eur J Endocrinol). In order to elucidate~     mechanism of this treatment strategy in vivo, we plan to recruit 20-30 patients with GD and~     treat those patients by intrathyroid injection of DEX combined with methimazole, and the~     function of Treg cells and balance of Th1/Th2 will be evaluated.~   "
155250|NCT01534143|"~     This pilot phase II trial studies how well giving high dose busulfan together with bortezomib~     works in treating patients with high risk multiple myeloma undergoing stem cell transplant.~     Drugs used in chemotherapy, such as busulfan, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cells growth.~     Giving busulfan together with bortezomib before a stem cell transplant may kill more cancer~     cells~   "
155251|NCT01534130|"~     The investigators will conduct acupuncture for participants with chronic fatigue~     syndrome(CFS). Firstly the investigators aim to figure out the characteristic of sleep~     structure of CFS and the changes caused by acupuncture. Secondly the investigators seek to~     investigate the characteristic of sleep-wake rhythm, slow wave sleep(SWS)-rapid eye~     movement(REM)sleep rhythm, and REM sleep rhythm of CFS and the readjusting of acupuncture for~     it. Thirdly the investigators want to know the efficacy of acupuncture for relieving the~     fatigue, reducing accompanying symptoms and for improving the life quality of CFS.~   "
155252|NCT01534117|"~     The investigators are assessing the platelet function analysis of those who sustained~     significant head trauma while on aspirin or plavix and to assess if any qualitative~     difference is obtained if platelets are administered.~   "
155253|NCT01534104|"~     Many patients with brain tumors require surgery. Some patients have brain tumors near~     important parts of the brain. These brain areas have roles in language or motor function.~     Avoiding these motor and language areas helps to prevent neurological deficits. The~     investigators are studying the parts of the brain involved in motor and language. Patients~     usually get functional MRI (fMRI) or resting-state fMRI (rs-fMRI) for gray matter mapping and~     diffusion tensor imaging (DTI) or diffusion spectrum imaging (DSI) for white matter mapping.~     These special MRI sequences are used to plan surgery. Patients are scheduled to have imaging~     to help plan for possible surgery.~      Some patients may require stimulation during surgery to motor and language areas. In patients~     who require stimulation as part of their standard of care, the investigators will compare the~     investigators imaging results with the stimulation results. The purpose of this study is to~     improve MRI mapping of the motor and language pathways in the brain.~      The scans are necessary stimulation for this protocol are part of the standard of care. In~     other words, these tests are done as part of the best possible care even if they did not join~     this study. The investigators are studying new techniques for analyzing the MRI data. These~     new techniques may give the doctor a better view of where the brain tumor is located relative~     to important parts of the brain.~      The investigators will only perform the test sequences that are necessary for mapping the~     tumor. Most patients will require both fMRI and DTI. Some patients may only require fMRI or~     DTI. The investigators may also ask to perform optional sequences during the scan. Multi-echo~     is an modified form of fMRI. DSI is a modified form of DTI. These optional sequences are for~     research only. The patient would not get these sequences if they do not enroll in this study.~   "
155296|NCT01533532|"~     The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with~     endometriosis.~   "
155255|NCT01534078|"~     Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a~     protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the~     antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy~     portion, which attempts to destroy the cell.~      The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you~     will receive in this research study are approved for use in people with Hodgkin Lymphoma. A~     drug called bleomycin is usually included with AVD, but since it appears to be a less~     effective drug with significant potential risks, it is being replaced in this study with the~     drug brentuximab.~      In this research study, the investigators are looking to see whether brentuximab in~     combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.~   "
155256|NCT01534065|"~     The purpose of this multi-center post marketing surveillance study is to monitor the safety~     and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the~     L1 - S1 spinal disc.~   "
155257|NCT01534052|"~     A study to assess the safety of continued administration of MDV3100 in subjects with Prostate~     Cancer who have already undergone treatment with MDV3100 and showed benefit.~   "
155258|NCT01534039|"~     A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or~     urostomy.~      Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin~     protection, wear-time, ease of use, ease of teaching, and comfort.~   "
155259|NCT01534026|"~     Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function as~     a pump to move blood around the body. Aspirin has been traditionally used in heart failure~     because a tendency towards blood clots (including stroke and heart attack, clots in the legs~     and in the lungs) has been observed in this group and aspirin's mechanism of action is to~     prevent blood clots. This is important because two-thirds of cases of heart failure are~     caused by a blood clot in the coronary artery resulting in a heart attack, and aspirin is~     given to reduce the chances of further heart attacks.~      However aspirin was introduced before clinical trials as the investigators know them now were~     run. Systematic review of the trials of aspirin in heart failure has shown that its use does~     not increase survival, and there is no evidence to recommend its routine use. Another~     important finding was that use of aspirin may reduce the beneficial effects of ACE inhibitors~     which do have a mortality benefit, and that aspirin was associated with an increase in~     hospitalisation for heart failure compared to other drugs which prevent clots or placebo.~      The investigators propose that the use of aspirin in heart failure that is not caused by~     heart attacks (non-ischaemic cardiomyopathy) is unnecessary and could be stopped. The~     importance of finding evidence to cease unproven medications in heart failure cannot be~     understated. Patients with heart failure take an average of six prescription medications each~     day. Each medication has side effects and the interactions of all the drugs together are~     unknown. Aspirin itself is a drug which frequently has side effects of increased risk of~     bleeding, gastrointestinal ulceration, as well as kidney impairment.~      In this study, the investigators plan to withdraw aspirin from patients with stable~     non-ischaemic heart failure in a closely monitored environment and watch for the effect of~     this on heart failure.~   "
155260|NCT01534013|"~     The purpose of the study is to assess the safety and efficacy of the Imperial College closed~     loop insulin delivery system (artificial pancreas) in subjects with type 1 diabetes.~   "
155261|NCT01534000|"~     Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective~     randomized controlled trial designed to evaluate the clinical value of cardiac multidetector~     computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest~     pain, compared to a conventional functional-based testing strategy.~      Methods:~      Consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal~     electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary~     angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial~     perfusion imaging - MPI (Control group).~      After one year, patients will be followed-up, with registration of clinical endpoints such as~     Cardiac death, myocardial infarction, need for revascularisation, admittance for heart~     related problems, sustained chest pain, live quality score, use of medication.~   "
155262|NCT01533987|"~     The purpose of the study is to determine the effects of daily ingestion of Juice Plus+®~     capsules containing Orchard, Garden and Vineyard blends on endothelial function and~     biomarkers of oxidative stress (oxidized LDL, lipid hydroperoxides and protein carbonyls) in~     overweight men as compared to the placebo group.~   "
155263|NCT01533974|"~     The overall aim of this 5-year project is to capitalize on the strong theoretical and~     promising empirical evidence for Acceptance & Commitment Therapy (ACT) as an intervention for~     smoking cessation by comparing the effectiveness of ACT against standard cognitive behavioral~     therapy (CBT) counseling when both are offered with nicotine replacement therapy (NRT) and~     delivered within a real world healthcare setting.~   "
155264|NCT01533961|"~     This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158~     in healthy volunteers. In animal models of both acute and chronic experimental~     Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy.~   "
155265|NCT01533948|"~     This phase II trial studies how well axitinib works in treating patients with melanoma that~     has spread to other places in the body or cannot be removed by surgery. Axitinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
155266|NCT01533935|"~     The primary objective of this trial is to investigate the effect of 6 weeks treatment with~     tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and~     exercise tolerance in patients with COPD.~   "
155267|NCT01533922|"~     The primary objective of this trial is to investigate the effect of 6 weeks treatment with~     tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and~     exercise tolerance in patients with COPD~   "
155268|NCT01533909|"~     The aim of the study is to develop a screenings tool that will enable hospital nurses to~     detect and stage cancer cachectic patients. The early detection and staging of cancer~     cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made~     patient care.~   "
155269|NCT01533896|"~     Parents should receive anticipatory guidance about obesity prevention as part of the routine~     well child visit. Educational resources are needed to help physicians routinely provide these~     important anticipatory guidance messages. In this study, consecutive parents will be exposed~     to routine anticipatory guidance messages before the well child visit with the physician.~     After the clinic visit, parents will be invited to participate in a research study to~     determine if they plan any changes at home. The key research question of this study is: Can a~     brief multimedia intervention help parents develop plans to help their children have a~     healthy weight?~   "
155270|NCT01533883|"~     Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a~     transfemoral delivery system. The aim of this study is to evaluate the performance and safety~     of the Cardioband for repair of mitral regurgitation.~   "
155273|NCT01533844|"~     The objective of this multi-center, prospective observational study is to determine the~     feasibility of a potential interventional study with fidaxomicin. The incidence and clinical~     aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will~     be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy~     might improve outcome.~   "
155274|NCT01533818|"~     The aim of the study is to determine optimal management of isolated fast breathing in young~     infants in a trial design conducted in primary care settings.~      The investigators hypothesized that proportion of infants who fail therapy will be 4% in each~     group. A 6% or less difference in failure rate will be considered equivalent.~   "
155275|NCT01533805|"~     The purpose of this study is to compare different methods of application of the Pilates~     Method with exercises in controlling in low back pain in women aged between 45 and 60 years.~     Two groups will be formed. One will do Pilates exercises with stabilization segmental. The~     other group will do classic Pilates exercises. Will be measure pre and pos intervention of~     the responses already shown above.~   "
155276|NCT01533792|"~     Objective: The objective of this research was to compare the effect of a single session~     supragingival scaling in a group of pregnant women with periodontal disease with a group that~     received supra and subgingival scaling.~      Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4~     teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing~     in the same place. Women were divided into two groups, the group 1 received supra and~     subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received~     only supragingival scaling with OHO too.~   "
155277|NCT01533779|"~     Examine neutrophil extracellular traps (NETs) formation, in relation to other neutrophil~     functions like chemotaxis, superoxide production, hydrogen peroxide production, and the~     presence of myeloperoxidase, in pediatric patients undergoing chemotherpy for solid and~     hematological malignancies. This data could shed new light on the mechanism responsible for~     the increased susceptibility to infection among these patients and aid in improving their~     prophylactic antimicrobial treatment.~      NETs formation against tumor cell lines and their ability to kill tumor cells will also be~     examined. The finding of NETs activity against tumor cells could have a major contribution to~     the investigators understanding of the function of the immune system against cancer.~   "
155278|NCT01533766|"~     The purpose of this study is to compare the safety and efficacy of CombiflexOmega in~     comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.~   "
155279|NCT01533753|"~     The purpose of this study is to assess the change in quality of life over a 6 month period~     between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes~     related to androgen deprivation therapy.~   "
155280|NCT01533740|"~     Aim of the present study is to investigate whether baseline or early post-treatment (one~     month after treatment commencement) frequency of peripheral T regulatory lymphocytes (Tregs~     OR CD4+/CD25high/FOXP3+ T cells), known to suppress antitumor immune response, may influence~     long-term clinical outcome (i.e. radiological response, progression-free survival or overall~     survival) in metastatic colorectal cancer patients treated with a standard first-line~     chemotherapy including fluorouracil, irinotecan and bevacizumab~   "
155281|NCT01533727|"~     Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main~     treatment for early stage patients is surgical resection, but about 30% -70% patients will~     relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection~     NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic~     adjuvant chemotherapy. It is necessary to further improve the survival time of patients with~     lung cancer. Biological treatment is becoming a new treatment modality for Cancer following~     with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant~     treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK)~     characterized as fast amplification, strong anti-cancer activity and broad anti-tumor~     spectrum is most widely used and thought to be the first choice for the new generation of~     anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of~     Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy for~     stage IB-IIIA NSCLC.~   "
155282|NCT01533714|"~     The primary objective of this study is to assess the long-term safety of CDP6038.~   "
155283|NCT01533701|"~     The purpose of this study is to compare lactate and total acid-base status in fetal scalp~     blood with lactate and total acid-base status in maternal blood and amniotic fluids to~     provide information on how lactate and base deficit correlates with scalp samples.~      Furthermore, the investigators want to study whether angiogenic factors in fluids above may~     be a possible marker of asphyxia during labor.~   "
155284|NCT01533688|"~     Poor bowel preparation and patient intolerance of the procedure are the most important~     factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in~     incomplete testing, increased potential to miss lesions, increased cost, and decreased~     patient satisfaction. The investigators hope to gain better insight into which bowel~     preparation works best in diabetic patients and hence would increase patient satisfaction,~     tolerability of the bowel preparation and decrease overall costs. The investigators will~     investigate which bowel preparation for colonoscopy will work optimally in diabetic patients~     using three different regimens.~   "
155285|NCT01533675|"~     Sutures are an integral part of surgery and available materials are diverse, as are the~     options for post-procedure care. Both saline and hydrogen peroxide are commonly used~     cleansing agents. This study aims to compare the effect of saline and hydrogen peroxide on~     the tensile strength of 4-0 nylon sutures following removal from a cutaneous surgical wound.~   "
155297|NCT01533519|"~     This study is designed to investigate the safety of intranasal administration of NPY using a~     dose escalation, randomized, double-blinded, placebo-controlled crossover design in a~     medication-free, symptomatic PTSD group.~   "
155298|NCT01533506|"~     The patient has failed all other available agents and has intractable epilepsy due to Dravet~     Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy~     with Stiripentol are primarily to significantly reduce the frequency and severity of~     seizures.~   "
155362|NCT01532648|"~     This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as~     add-on therapy to an existing oral 5-ASA regimen for the induction of remission in patients~     with active, mild or moderate ulcerative colitis (UC).~   "
155286|NCT01533662|"~     Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This~     loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation~     resulting in hypotension. A severe and prolonged hypotension can compromise regional~     perfusion and worse outcome especially in very elderly patients. Moreover the venous~     vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a~     cardiac output decrease. Several authors had identified the prevention of hypotension as a~     key role during spinal anesthesia although none prophylactic treatment has been identified.~     Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous~     spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension.~     Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic agonist~     and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine infusion for~     preventing hypotension has been demonstrated during spinal anesthesia for cesarean delivery.~     The investigators want to assess for the first time the prophylactic phenylephrine infusion~     for preventing hypotension in elderly patients undergoing orthopedic lower limb surgery under~     spinal anesthesia single injection.~   "
155287|NCT01533649|"~     The assumption of the unpredictability of seizures may have an enormous impact on the~     perception of self-efficacy and may contribute more to a patient's poor quality-of-life than~     the actual seizures. Patients with epilepsy are especially susceptible to the influence of~     the arbitrary nature of this condition on socialization,education,and the formation of~     self-identity. Consequentially, the psychosocial and psychological aftermath is likely to be~     observed even in individuals with well-controlled seizures. The relationship between seizure~     occurrence and the effects of having epileptic seizures on quality of life can be~     characterized as reciprocal; e.g. emotional stress is not only a result of having seizures;~     it is also the most frequently reported seizure precipitant. Whereas behavioral interventions~     have repeatedly been considered as the third pillar of the treatment of epilepsy, the main~     focus still remains on passive seizure control per pharmacological and surgical~     interventions, which may further aggravate victimization. Outcome after epilepsy surgery is~     closely correlated with pre-surgical characteristics. Consequentially, there is an upsurge of~     interest in the medical community for research on non-pharmacologic interventions to~     facilitate the transition from chronically sick to well with preventive therapeutic~     interventions in the context of habitual seizures. The Andrews/Reiter (AR) approach to~     epilepsy is a systematic counseling intervention that assists the individual to identify~     seizure warning signs,seizure precipitants and general life stressors in order to develop~     strategies of active seizure control and improve self-defined life quality. Literature review~     indicates that AR represents the most comprehensively developed psychological approach. The~     proposed trial will address the question if AR decreases seizure frequency and~     psychopathologic comorbidities and increases seizure self-efficacy and overall quality of~     life in patients with medically intractable epilepsy.~   "
155288|NCT01533636|"~     The investigators will collect samples of sputum from healthy volunteers and patients with~     cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding~     studies and; b) assessment of the effects of carbohydrates on the rheologic properties of the~     sputum.~      This study has two hypotheses:~        1. Lectins from Pseudomonas aeruginosa and Aspergillus fumigatus bind to airway mucins in a~          fucose-dependent manner, and this binding can be inhibited by fucosyl glycomimetic~          compounds.~        2. Fucosyl glycomimetics will compete with Pseudomonas aeruginosa lectin (PA-IIL) and~          Aspergillus fumigatus lectin (AFL) and disrupt lectin-driven mucin cross-linking in CF~          sputum.~   "
155289|NCT01533623|"~     The investigators will perform a 1-year clinical trial measuring objective compliance during~     mandibular advancement device (MAD) treatment.~      The investigators will enroll 50 patients that received treatment with a titratable, duobloc~     MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original study~     Objective versus subjective compliance with oral appliance therapy for obstructive sleep~     apnea hypopnea syndrome, registered at Clinical Trials.gov (NCT01284881).~      Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided by~     the Handelsagentur Gschladt without any costs. The sampling interval of the recording will be~     done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample~     interval, the capacity of the active microsensor allows for data acquisition during a 100 day~     period.~      A follow-up appointment is scheduled +/- 265 days after the start of the original study. A~     second follow-up visit is scheduled again 1 year after the start of the original study.~      The objective measurement of MAD wear time (total hours of wear time and the mean hours of~     wear per night over the respective period) will be based on the assumption that the MAD has~     been worn when the chip records a temperature intraorally.~   "
155290|NCT01533610|"~     RATIONALE: A stellate ganglion nerve block may help relieve symptoms of post-traumatic stress~     disorder (PTSD).~      PURPOSE: This pilot clinical trial is studying the efficacy of a stellate ganglion nerve~     block in veterans to reduce the symptoms of PTSD in relatively long-standing (Vietnam era)~     induced or relatively recently induced PTSD (from deployment in Afghanistan or Iraq as part~     of Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND).~   "
155291|NCT01533597|"~     The aim of the study is to investigate if the combination therapy consisting of~     anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive~     Bladder (OAB).~   "
155292|NCT01533584|"~     The aim of this study is to evaluate nocturnal hypertension with 24-hour ambulatory blood~     pressure and home blood pressure (BP) measurements through a) comparison of mean BP and~     nocturnal dipping assessed with the two methods, b) correlation of those parameters with~     parameters of target-organ damage and c) comparison of the potential of the two methods to~     define non-dippers.~   "
155293|NCT01533571|"~     This study aims to examine dimensional alveolar ridge alterations and prevent buccal plate~     resorption and soft tissue recession following immediate implant placement in extraction~     sockets in the maxillary esthetic zone using different socket morphology-guided treatment~     modalities.~      Expected results of the study are:~        -  To have found the optimal materials and GBR procedures modalities for buccal plate~          resorption degree reduction;~        -  Soft tissue recession and best esthetic result achievement. There will be possibilities~          to study socket morphology influence on final esthetic result achievement.~   "
155294|NCT01533558|"~     The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to~     non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU~     patients, who will get caspofungin as standard care.~      Full PK curves will be taken on day 3 and a limited PK curve on day 7, trough levels will be~     taken daily.~   "
155295|NCT01533545|"~     The aim of this study is to determine the effect of epinephrine on systemic absorption of~     local anaesthetic mepivacaine administered for brachial plexus block in uremic patients~     scheduled for creation or repair of an arteriovenous fistula. Furthermore, an impact of~     epinephrine on the central circulation and peripheral tissue oxygenation will be evaluated.~   "
155299|NCT01533493|"~     This is a 12-week clinical trial evaluating the efficacy and safety of memantine~     hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults with~     Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with~     OROS-Methylphenidate (OROS-MPH, Concerta). The study aims to examine the effects of treatment~     with memantine on ADHD symptoms. Following screening procedures, memantine is prescribed in~     randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks, along~     with open-label OROS-MPH (everyone receives medication).~   "
155300|NCT01533480|"~     The investigators are conducting this study because the patient have an eye infection which~     is called adenoviral conjunctivitis, and is the most common cause of pink eye. There is~     currently no treatment for this condition. However, the researchers associated with this~     study want to understand if using a product called Zirgan, which is a topical ointment that~     is already FDA-approved for other types of eye infections, will help with the type of~     infection that the patient currently have. Zirgan is not FDA-approved to treat your type of~     eye infection. Your participation in this study is expected to last 21 days but the patient~     will only apply the topical ointment for 14 of those days. During the study, the patient will~     be asked to come into this clinic 8 times.~      The purpose of this study is to determine whether topical Zirgan can reduce days that the~     patient suffers from the eye infection, and also to see if it can prevent the infection from~     spreading to your second eye and to also see if it can prevent the spreading of the infection~     to people that the patient come in close contact with.~      Zirgan will be compared to Genteal Gel in this trial. Genteal Gel is a non-prescription eye~     lubricant gel and is commonly used for treatment of dry eye.~      The patient will be asked to apply a topical ointment (either Zirgan or Genteal gel 5 times a~     day for the first 7 days and then 3 times a day for the following 7 days. The patient will be~     asked to return to the clinic 21 days after the patient starts the study for a final~     check-up.~      It is planned that about 80 people with Adenovirus Conjunctivitis will be enrolled in this~     study between 8-12 sites across the United States.~      The patient will be assigned to either Zirgan or Genteal gel by chance which is similar to~     flipping a coin.~      The study groups will be assigned in a 1:1 ratio. Neither the patient nor the study doctor or~     study staff will be able to pick which study group The patient is in. The patient will not~     know and the study doctor or study staff will not know which study group the patient is in.~     The study doctor or study staff can find out if it is necessary to know for your health. If~     this happens, the study doctor or study staff may not be able to tell the patient which study~     group the patient was in until everyone finishes the study.~   "
155301|NCT01533467|"~     Objective:~      To investigate the protective effects of a newly invented device for reducing tears in the~     perineum during vaginal childbirth.~      Design:~      A multicenter randomized control trial performed at three hospitals in Sweden, in~     Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200),~     cephalic presentation. They will be randomized to an intervention group, with a perineal~     protection device, and a control group deliver as normal.~      Main outcome measures:~      The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter~     rupture are measured.~   "
155302|NCT01533454|"~     The purpose of this study is to test the extent to which incentives, when combined with an~     existing evidence-based weight loss program, improve weight loss and weight loss maintenance.~     It will also compare the cost-effectiveness of the incentive-based weight loss programs to~     the basic program without incentives.~   "
155303|NCT01533441|"~     The objective of the SAFE K study is to demonstrate that in patients treated with the~     antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally~     produced by the ferments used in fermented dairy products, does not upset the balance of~     anticoagulant treatment.Fifty-two patients will be chosen to receive either verum or placebo~     for four months after a 4-month run-in period.In addition, the study evaluates if regular~     consumption of vitamin K2 reduce the need of changing the dose of anticoagulation treatment~     and improve the markers of bone mineralisation.~   "
155304|NCT01533428|"~     The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin~     8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused~     by diabetes.~   "
155305|NCT01533415|"~     Is CES effective in the treatment of anxiety when accounting for any comorbid conditions and~     or current treatments including medication and psychotherapy.~   "
155306|NCT01533402|"~     The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a~     feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia,~     panic disorder, specific phobia, generalized anxiety disorder or separation anxiety~     disorder). The program is directed toward both the parents and children. The patients work~     with the treatment is supported through on-line contact with a therapist. Approximately 128~     patients will be included in the study and randomized to either condition. All included~     patients are assessed before the treatment starts and after 10 weeks (post treatment).~     Follow-up assessments are conducted at 3 and 12 months after treatment.~   "
155307|NCT01533389|"~     A lower ureteral calculus, which measures 5 millimeters and less, may be easily expelled by~     symptomatic therapy. Actually, it has about a 50% chance of successful expulsion.~      However, a complication such as urinary tract infection or hydronephrosis or persistent pain~     may occur before it is expelled. Thus, it is imperative to minimize the occurrence of~     complications in the process of expectant treatment and also to reduce the time required to~     expel calculi.~      Pharmacotherapy is to relieve ureteral obstruction and thus to expel urinary calculi easily.~      This clinical trial is to evaluate the efficacy of silodosin, a selective α1A-blocker, on~     calculous expulsion in expectant treatment for patients with lower and mid ureteral calculi.~   "
155308|NCT01533376|"~     Primary Objective:~      • To assess the possible utility of topical timolol in the management of port-wine mark (PWM)~     in Sturge-Weber syndrome in children.~   "
155309|NCT01533363|"~     The purpose of this study was to determine the influence on Patient comfort after Stapled~     Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular~     hemorrhoids.~   "
155310|NCT01533350|"~     Twenty eight infertile women undergoing ultrasonographic endometrial assessment in the late~     follicle phase, fourteen of them with homogeneous echo endometrium (group 1) and other~     fourteen with trilaminar endometrium (group 2), were included from our Department. The~     endometrial tissues were collected and Four biomarkers for endometrial receptivity and~     ultrastructure were assessed before and 6-7 days after ovulation.~   "
155311|NCT01533337|"~     The aim of the current report is to investigate the feasibility of transferring the free~     dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to~     reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed~     digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of~     the donor middle and ring fingers was measured.~   "
155312|NCT01533324|"~     S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in~     Hepatocellular Carcinoma (HCC). S-1 combined with calcium folinate (SL) showed very good~     efficiency and safety in colorectal cancer (CRC). The short duration (two weekly regimen) is~     better than common course 4 week regimen in tolerance. So the investigators want to examine~     the efficiency and safety of SL one week on and one week off regimen in HCC.~   "
155316|NCT01533272|"~     As a measure of secondary prophylaxis, and with the final objective of avoiding the~     infection, it has been suggested to use antiretroviral therapy. This is known as~     post-exposure prophylaxis (PEP).~      Although there are different recommendations, almost every guideline recommend using 3 drugs~     as PEP both in USA and Europe.~      Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are~     attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.~      A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus~     the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases), with a~     10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul~     be an adequate drug for PEP.~   "
155317|NCT01533259|"~     This study will evaluate the efficacy of Stribild®~     (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF))~     single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus~     Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in~     virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety,~     tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.~   "
155318|NCT01533246|"~     This phase II trial studies how well linsitinib works in treating patients with asymptomatic~     or mild symptomatic metastatic prostate cancer. Linsitinib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
155319|NCT01533233|"~     The purpose of this study is to study the safety and results of thoracoscopic lobectomy using~     non-intubated thoracic epidural anesthesia versus intubated general anesthesia for lung~     cancer patients.~   "
155320|NCT01533220|"~     The common cold is a major cause of nasal obstruction and reaches children and adults twice~     or more times a year. At the moment, there is no cure for the common cold, and therefore the~     reduction of symptoms is the focus of treatment.~      The study was designed to parallel distribution, with two equal groups, with one group will~     receive treatment with a combination of naphazoline hydrocloride + pheniramine maleate +~     panthenol and the other will receive treatment with naphazoline hydrocloride.~   "
155321|NCT01533207|"~     This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel~     followed by doxorubicin hydrochloride work compared to observation in treating patients with~     high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy,~     such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether~     combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.~   "
155322|NCT01533194|"~     This pilot phase I trial studies the side effects and the best dose of giving viral therapy~     to patients with relapsed or refractory multiple myeloma. Viral therapy, such as wild-type~     reovirus, may be able to kill cancer cells without damaging normal cells.~   "
155323|NCT01533181|"~     The purpose of this study is to evaluate how OSI-906 compares to Topotecan in trying to slow~     down the growth and/or progression of the tumors of participants with relapsed or recurrent~     Small Cell Lung Cancer.~      This study also plans to find out what effects, good or bad (side effects), OSI-906 has on~     participants and or Small Cell Lung Cancer. The study will also investigate if some proteins~     measured in the blood or tumor and some imaging features obtained from computed tomography~     (CT) scans can help predict whether OSI-906 or topotecan will be effective against Small Cell~     Lung Cancer.~   "
155324|NCT01533168|"~     RATIONALE: Testing for minimal residual disease in cell samples from patients with acute~     lymphoblastic leukemia may help doctors plan better treatment.~      PURPOSE: This research trial studies a genetic test in identifying previously undetectable~     minimal residual disease in cell samples from younger patients with acute lymphoblastic~     leukemia.~   "
155325|NCT01533155|"~     Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics~     of NKTR-118~   "
155326|NCT01533142|"~     Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is~     now an established treatment at several other hospitals in the health region (Voss Hospital~     (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse~     Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund:~     gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion~     with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in~     Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from~     different surgical methods.~      This project is part of the regional strategic research initiative in the Helse Vest~   "
155327|NCT01533129|"~     The study searched for answers to two questions~        1. What is the effect of testosterone replacement therapy on endothelial dysfunction,~          inflammation and insulin resistance?~        2. Regarding the above parameters, is there any difference between daily transdermal~          testosterone implementation and intramuscular injection performed in three weeks.~   "
155328|NCT01533116|"~     To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa~     pharmacokinetics~   "
155329|NCT01533090|"~     The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the~     procedure is safe and effective. It has been the standard cleansing regimen for the last 25~     years. To overcome the difficulty in completing the bowel preparation due to large volume~     and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been~     shown to provide adequate colon cleansing and better tolerability.~      LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with~     bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing~     prior to colonoscopy thanks to the reduced volume and improved taste. The present study is~     intended to compare the new dosing regimen of the bowel lavage solution given the same day~     compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.~   "
155330|NCT01533077|"~     To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA~     9-1067 or 1 hour after.~   "
155397|NCT01532167|"~     The purpose of this study is to demonstrate that [18F]FDG PET is a a better method than~     clinical and laboratory values for the identification and assessment of inflammatory activity~     in patients with Takayasu Arteritis (TA), allowing long-term follow-up with a precise~     evaluation of response to therapy.~   "
155331|NCT01533064|"~     Objective: Reports have described how hospitalized psychiatric patients respond to disasters;~     however, few reports have described the response to disaster among psychiatric outpatients,~     who have relatively mild disease in comparison with hospitalized, severely ill psychiatric~     patients. Here the investigators have analyzed the response to disaster among this~     under-studied population.~      Method: The Great East Japan Earthquake on March 11, 2011, was a catastrophic disaster. The~     investigators studied psychiatric change among a population of psychiatric outpatients in~     Tochigi prefecture, located ~160 km (~100 miles) southeast of the Fukushima nuclear power~     plant, in an area that suffered moderate damage from the earthquake. A total of 328~     psychiatric outpatients were enrolled and were grouped into the diagnostic categories F2~     (schizophrenic, schizotypal, and delusional disorders), F3 (affective disorders), and F4~     (neurotic, stress-related, and somatoform disorders). All diagnoses were made using~     International Classification of Diseases (ICD) 10 criteria. Changes in symptoms were measured~     as a change in psychotropic medication after the disaster.~   "
155332|NCT01533051|"~     The aim of this study is to investigate the off-treatment sustained virological and~     biochemical response in chronic hepatitis B patients following the guideline by the Asian~     Pacific Association for the Study of the Liver (APASL) in Korea.~   "
155333|NCT01533038|"~     The purpose of this study is to compare the UroLift System Treatment to Transurethral~     Resection of the Prostate (TURP) in improving a patient's overall quality of life, while~     evaluating healthcare expenditures associated with each therapy.~   "
155334|NCT01533025|"~     The clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles~     allograft are comparable to those using Achilles allograft with bone block on its end.~   "
155335|NCT01533012|"~     The purpose of this study is to investigate a performance of initial positioning of left~     sided double lumen endobronchial tubes using peak inspiratory pressures difference between~     two lungs.~   "
155336|NCT01532999|"~     Currently, veterans with posttraumatic stress disorder (PTSD) are typically treated with~     antidepressants which have limited efficacy and yield extremely low remission rates. New and~     improved treatments are sorely needed, especially in light of the inadequate evidence to~     support the efficacy of most pharmacologic and most psychotherapy treatments for PTSD.~     Complementary and Alternative Medicine practices, such as meditation, may fill this void.~     Several other illnesses often found in association with PTSD, such as chronic pain, anxiety,~     and depression, have shown positive response to meditation, specifically Mindfulness Based~     Stress Reduction (MBSR). MBSR is manualized program involving 8 weekly classes and a single~     6-hour silent retreat session based on a systematic procedure to develop enhanced~     non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~     MBSR is well tolerated, already well disseminated. MBSR has been shown to be effective in~     reducing conditions that are commonly associated with PTSD, including pain, depression,~     anxiety and panic, and insomnia. The investigators are conducting a multisite study of~     Mindfulness Based Stress Reduction (MBSR) compared to Present Centered Group Therapy (PCGT)~     for the treatment of PTSD. The primary aim of this study will be to determine how well the~     MBSR form of meditation, i.e. MBSR, works to treat symptoms of PTSD in veterans compared to~     PCGT. The investigators will evaluate the effects of treatment on levels of mindfulness,~     depression, PTSD symptom clusters, and response rates. The investigators will evaluate~     veterans' satisfaction and acceptability of the MBSR intervention. Additionally, biomarkers~     will be utilized to aid in our understanding of the pathophysiology of meditation and explore~     the relationship between treatment outcome and neuroimmune response.~   "
155337|NCT01532986|"~     Health care benefits and services are received through the Veterans Health Administration~     (VHA), a component of the United States Department of Veterans Affairs. Over 40,000 Veterans~     across the Veterans Health Administration are diagnosed with Parkinson's disease (PD), a~     chronic condition that affects motor function as well as cognition, mood, sleep, and~     autonomic function. There are not enough subspecialists to manage every Veteran with~     Parkinson's disease. However, a care model of nurse care managers as catalysts and advocates~     using needs assessments, evidence-based protocols, and VHA and community access coordination~     mechanisms to optimize Parkinson's disease care may improve quality of Parkinson's disease~     care and patient-centered outcomes. If efficacious, this model may be practical to~     disseminate via an existing VHA national consortium network for Parkinson's disease.~      Objectives are (1) to implement then analyze via a randomized controlled trial whether a~     nurse-led, coordinated care management intervention, Care Coordination for Health Promotion~     and Activities in Parkinson's Disease (CHAPS), compared to usual care will improve adherence~     to evidence-based practice guidelines and improve health outcomes in Veterans with~     Parkinson's disease in a region of the southwest United States, and (2) to analyze extent of~     implementation of the CHAPS intervention and its costs to determine how the intervention can~     be made sustainable and disseminated throughout Veterans Affairs Medical Centers if~     efficacious.~   "
155338|NCT01532973|"~     The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics~     of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts~     to this study; Part I will enroll only genotype (GT) 1 HCV-infected participants, Part II~     will enroll GT3 HCV-infected participants, and Part III will enroll only GT1a HCV-infected~     participants. All parts may run concurrently, or Parts II and III may be staggered.~      Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in~     HCV-infected participants, elbasvir administered for 5 consecutive days has superior~     antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by~     change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5, 24-hour~     postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).~      Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants,~     the mean maximum reduction in HCV viral load is greater following multiple dose oral~     administration of elbasvir as compared to placebo.~      Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in~     HCV-infected participants, elbasvir administered for 5 consecutive days has superior~     antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by~     change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose~     timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).~   "
155350|NCT01532817|"~     The purpose of this pilot study is to collect preliminary clinical data related to the safety~     and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™~     device for the relief of acute bronchoconstriction due to asthma.~      Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the~     study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic~     settings capable of treating any potential complications of bronchoconstriction, an acute~     exacerbation of asthma, and any emergencies associated with use of the investigational~     device.~   "
155339|NCT01532960|"~     Despite advances in surgical, radiation and medical therapies of early stage breast cancer,~     some patients will experience disease recurrence. Because recurrence may not happen for years~     after definitive treatment, there is a period of time between resection and relapse when~     micrometastatic disease may be amenable to immune eradication or modulation. While the~     ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast~     immunotherapy is to define treatments that have immunologic efficacy. In this study, the~     investigators will determine whether a vaccine consisting of nine-class I breast specific~     peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with~     poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.~   "
155340|NCT01532947|"~     This in vivo study examined the contribution of remaining coronal dentin and placement of a~     prefabricated or customized fiber post to the six-year survival of endodontically treated~     premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic~     treatment. Groups were classified according to the number of remaining coronal walls before~     abutment build-up. Within each group, teeth were allocated to three subgroups: A) no~     post-retention; B) LP; C) ES (N=20). All teeth were protected with a crown. Cox regression~     analysis was applied to assess whether the amount of residual coronal dentin and the type of~     endocanalar retention had a significant influence on failure risk of the restored teeth.~   "
155341|NCT01532934|"~     Substance use among criminal offenders constitutes a major public health problem and is tied~     to negative consequences for offenders, their families, and their communities. One of the~     direst of these consequences is repeated incarceration; thus, interventions that reduce~     criminal recidivism are needed. Forensic populations are often viewed with considerable~     therapeutic pessimism. However, offenders exhibit heterogeneity in personality traits, and~     the assessment of individual differences among offenders may provide valuable information~     that guides the use of psychotherapeutic interventions. Among offenders, psychopathy has~     emerged as an important personality construct for the understanding of violence and criminal~     recidivism. Moreover, core traits of psychopathy such as lack of empathy, deceitfulness, and~     lack of remorse may have negative implications for the efficacy of psychosocial~     interventions. A foundational premise of the present work is that understanding the~     moderating role of psychopathic traits on substance use treatment outcomes among offenders is~     essential to determining what works, and for whom. The current proposal is a Phase II~     randomized clinical trial that aims to examine the impact of psychopathic traits on the~     efficacy of a brief substance use intervention for offenders in a jail diversion program.~     Hypotheses that will be examined include: 1) that a Motivational Interviewing (MI) - based~     treatment will reduce substance use and related consequences relative to a Standard Care only~     condition, 2) that the reduction in substance use in the intervention group will mediate a~     reduction in later criminal recidivism relative to the Standard Care condition, and 3) that~     core psychopathic traits will moderate the efficacy of the intervention such that individuals~     with lower levels of these traits will derive greater benefits with regard to decreased~     substance use, decreased drug use consequences, and decreased criminal recidivism at a~     one-year follow-up.~   "
155342|NCT01532921|"~     Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in~     order to position this product on the market, a post-market release study was completed. The~     purpose of this study was to evaluate the hemodynamic performance of the Contour 3D®~     Tricuspid Annuloplasty Ring following Tricuspid Valve repair in a post-market environment.~   "
155343|NCT01532908|"~     The purpose of this study is to assess efficacy of a human monoclonal antibody against~     Hepatitis C (MBL-HCV1) combined with telaprevir [part 1: an HCV protease inhibitor] or~     sofosbuvir [part 2: an HCV NS5B polymerase inhibitor] in a 56 day treatment duration in~     patients undergoing liver transplantation due to chronic HCV infection. There is an option~     for extended study treatment through 84 days if viral load is undetectable at day 56.~   "
155344|NCT01532895|"~     The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat~     cancer pain in patients who have not been treated with a strong opioid.~   "
155345|NCT01532882|"~     Diosmin has a well established use status in improvement of the symptoms of venolymphatic~     insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of~     capillary fragility.~      Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo,~     to establish its efficacy in the pain relief in Chronic Venous Disease (CVD).~      The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600~     mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre,~     controlled, randomised, double blind, placebo-controlled, parallel-group study.~   "
155346|NCT01532869|"~     This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study~     will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with~     systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162~     mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants~     will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on~     study treatment is 96 weeks.~   "
155347|NCT01532856|"~     This protocol is an international, multicenter, comparative, open and randomized study~     designed to compare the safety and efficacy (in terms of response rate) from three induction~     chemotherapy schemes -Thalidomide/Cyclophosphamide/Dexamethasone versus~     Thalidomide/Dexamethasone versus Thalidomide/Melphalan/Prednisone. Finally, this study is~     also designed to compare the safety and efficacy (in terms of duration of response) of two~     maintenance chemotherapy regimens - Thalidomide/Prednisone versus Thalidomide. Each treatment~     arm will include 100 patients and assessments and scheduled visits will be conducted in three~     periods: Pre-treatment, treatment and monitoring. Security will be evaluated by monitoring~     all adverse events, physical examination, vital signs and biochemical studies. Response to~     treatment will be evaluated according to the EBMT21 criteria and will be assessed on day 1 of~     each cycle of induction, at the end of nine cycles of induction therapy and monthly during~     the first year of maintenance therapy and every 3 months thereafter.~   "
155348|NCT01532843|"~     Treatment with a nucleoside analogue and subsequent viral decline has shown to partially~     restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies~     investigating whether the effect of lowering viral load with nucleoside analogue therapy~     prior to the initiation of peginterferon results in higher sustained off-treatment responses~     showed contradictory findings.~      The aim of this study is to investigate sustained off-treatment response to peginterferon~     alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide~     analogues, thereby lowering viral load~   "
155349|NCT01532830|"~     The purpose of this pilot study is to assess feasibility and clarify the design of future~     study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or~     prevention of migraine symptoms.~   "
155351|NCT01532804|"~     This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and~     oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic~     colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.~   "
155352|NCT01532791|"~     Carriers of the m.3242A>G mutation often have clinical symptoms which can include migraines,~     seizures, strokes, hearing loss, balance issues, gastrointestinal issues, and many other~     symptoms. The investigators would like to learn more about these disorders and have designed~     a Natural History Study to monitor these conditions over time so that physicians and~     scientists can not only understand the problems that patients have, but work on developing~     treatments. The focus of the current work is to evaluate known mutation carriers of the~     m.3243A>G (mitochondrial DNA) and their maternal relatives (carrier status not a requirement~     for participation). Paternal relatives will serve as controls. This study involves no~     treatment.~   "
155353|NCT01532778|"~     The perception of fat represents major scientific and nutritional issues. This research aims~     to identify salivary markers that could predict and possibly explain this perception in~     healthy human being. This would help to develop nutritional strategies for a more rational~     consumption of fat.~   "
155354|NCT01532765|"~     Macular epiretinal membrane (ERM) is a semitranslucent, avascular, fibrocellular membrane on~     the inner surface along the internal limiting membrane (ILM) of the retina. ERM may cause~     symptomatic visual disturbances and vision loss. Since the 1970s, pars plana vitrectomy has~     been performed to remove the membranes with few complications, and surgical results are~     generally good. Recurrence rates of 5-16% have been reported. Recently, ILM peeling in ERM~     surgery have been popularized by a number of retrospective studies and one prospective case~     series to minimize the rate of ERM recurrences (16% recurrence in ERM surgery with ILM peel~     compares to 0% recurrence in ERM surgery without ILM peel). Surgical removal of the friable~     and transparent ILM is difficult and increases the risk of trauma to the retina. In addition,~     indocyanine green (ICG), a dye commonly used intra-operatively to enhance ILM visualization,~     is costly and has been shown to be toxic to the retina. The investigators study will be the~     first randomized-controlled multi-centred clinical trial to compare the outcomes of ERM~     surgery with and without ILM peeling. The results will help guide and standardize the~     surgical treatment of macular ERM; to minimize unnecessary surgical risks, as well as to help~     economize healthcare cost.~   "
155355|NCT01532739|"~     The purpose of this study is to investigate the feasibility and effectiveness of a cognitive~     training group in individuals with Mild Cognitive Impairment, using a new paradigm that will~     optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing~     traditional memory training with the teaching of an empirically-supported problem-solving~     approach, and (3) employing a clinically representative sample of individuals with MCI (e.g.,~     not excluding those with mild affective symptoms).~   "
155356|NCT01532726|"~     This is a multicenter, non-interventional, prospective study. The observation period~     comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with~     partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that~     occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of~     follow-up even if the final assessment is not performed.~   "
155357|NCT01532713|"~     Stellate ganglion block (SGB) is known to increase blood flow to the innervation area of the~     stellate ganglion. Near infrared spectroscopy reflects changes of blood volume and allows~     continuous, non-invasive, and bedside monitoring of regional cerebral oxygen saturation~     (rSO2). Previous studies have shown the increment of the rSO2 on the block side from the~     baseline and the decrement of the rSO2 on the non-block side after SGB. Patients with~     cerebral vascular disease undergoing SGB might be at risk a decrease in cerebral blood flow~     in the non-block side. The investigators researched the effect of oxygen administration on~     rSO2 in the non-block side using a near infrared spectroscopy after SGB. 5 L/min oxygen was~     supplied via nasal cannula from 15 minutes after SGB. The rSO2 in the non-block side were~     measured before SGB and 5, 10, 15, 20, 25 and 30 minutes after SGB.~      The present study suggests that oxygen administration can increase the rSO2 of non-block~     side. In conclusion, it is our belief that oxygen supplement is helpful to the patient with~     cerebral vascular disease during SGB.~   "
155358|NCT01532700|"~     This is a phase 2, open-label, single institution trial of combination of intravenous (IV)~     ofatumumab and oral GSK2110183 in patients with relapsed or refractory Chronic Lymphocytic~     Leukemia (CLL). Patients must have received at least one prior line of therapy containing~     fludarabine (single-agent or combination therapy). During the initial 6 months Treatment~     Phase, ofatumumab will be administered weekly for 8 doses, then once every 4 week cycle for~     an additional 4 doses (dose and schedule identical to the pivotal phase 2 trial) and~     GSK2110183 will be given daily PO (Treatment Phase). There will be an initial 10 day lead-in~     with GSK2110183 alone prior to initiation of ofatumumab to allow for evaluation of changes in~     cell surface expression due to GSK2110183 and for GSK2110183 pharmacokinetic studies (Lead-in~     Phase). The official Cycle 1 Day 1 will start on the date of first dose of ofatumumab. Cycle~     duration = 4 weeks. Patients will be assessed for safety, disease assessment, response, and~     survival on day 1 of each cycle during the Treatment Phase. A formal review of safety data by~     the Data Safety Monitoring Board (DSMB) after the first 6 patients have completed cycle 1 of~     the Treatment Phase will be performed before continuing accrual. All patients achieving SD,~     PR or CR by the end of the Treatment Phase will proceed to the Maintenance Phase. Patients~     with PD at any time, including by the end of Treatment Phase, will be taken off study. During~     the Maintenance Phase, single-agent GSK2110183 will be administered daily for a maximum of 12~     months (12 cycles). Maximum duration on any study drug is 18 months (18 cycles). During the~     Follow-up Phase, patients will be assessed for safety, disease assessment, response, and~     survival every 3 months through month 36 (year 3), or until subsequent CLL therapy or death,~     whichever comes first. Key indications for study withdrawal are progressive disease,~     intolerable toxicity, or completion of therapy~   "
155359|NCT01532687|"~     This randomized phase II trial studies how well gemcitabine hydrochloride works with or~     without pazopanib hydrochloride in treating patients with refractory soft tissue sarcoma.~     Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by~     blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride is~     more effective with or without pazopanib hydrochloride in treating patients with soft tissue~     sarcoma.~   "
155360|NCT01532674|"~     The goal of this study is to determine if patients with chronic periodontitis when undergoing~     with scaling and root planing (SRP) plus photodynamic therapy in comparison with SRP alone~     result in improved clinical, microbiological and biochemical outcomes.~   "
155361|NCT01532661|"~     The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not~     been proven yet in this context. A national register has been set up in France identifying~     the patients which received rFVIIa.~      Those patients had persistent and active bleeding after severe trauma despite surgery and/or~     interventional radiology embolization.~      The aim of this present study is to report the first clinical results in those situations of~     patients treated with rFVIIa.~   "
155363|NCT01532635|"~     This phase II clinical trial studies how well two donors stem cell transplant work in~     treating patients with high-risk hematologic malignancies. After receiving radiation to help~     further treat the disease, patients receive a dose of donors' T cells. T cells can fight~     infection and react against cancer cells. Two days after donors' T cells are given, patients~     receive cyclophosphamide (CY) to help destroy the most active T cells that may cause tissue~     damage (called graft versus host disease or GVHD). Some of the less reactive T cells are not~     destroyed by CY and they remain in the patient to help fight infection. A few days after the~     CY is given, patients receive donors' stem cells to help their blood counts recover. Using~     two donors' stem cell transplant instead of one donor may be more effective in treating~     patients with high-risk disease and may prevent the disease from coming back.~   "
155364|NCT01532622|"~     The purpose of this study is to determine the impact of blueberries on uric acid in patients~     with hyperuricemia that are not receiving uric acid pharmacotherapy. The central hypothesis~     the investigators propose is that daily blueberries added to a pre-existing diet will promote~     uric acid lowering and improve quality of life without detriment to vital signs.~   "
155365|NCT01532609|"~     This study is an intervention pilot that integrates the current methadone maintenance~     treatment (MMT) program in China with psychosocial and behavioral components in order to~     address the critical link between drug use and HIV/AIDS.~      The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the~     intervention manuals and supporting materials, and finalized assessment measures and~     implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT~     clinics involving 41 service providers and 179 clients, and followed up at three, six, and~     nine months.~   "
155366|NCT01532596|"~     The purpose of this study is to test if an 8-week mindfulness meditation training (vs a~     wait-list control condition) program reduces neurobehavioral reactivity and improves affect~     regulation in a sample of older adults, as measured by functional magnetic resonance imaging.~     Additionally, we will examine if mindfulness meditation training reduces loneliness and~     markers of chronic inflammation.~   "
155367|NCT01532583|"~     The aim of our study is to report the subjective and objective outcome of outside-in~     transobturator technique (TOT) (Monarc®) in long-term follow-up.~      This is a follow-up study concerning 191 patients operated on in Turku University Hospital~     between May 2003 and December 2004 by using TOT. SUI was diagnosed with a positive stress~     test, the Urinary Incontinence Severity Score (UISS) and the Detrusor Instability Score~     (DIS). After a mean of 6.5 years evaluation included a gynecological examination and a supine~     stress test. Subjective outcome was evaluated with UISS, DIS, a visual analogue scale (VAS),~     a questionnaire of subjective evaluation of continence, EuroQoL-5D, EQ-5D VAS and short~     versions of IIQ-7 and UDI-6. Objective cure was defined as negative stress test and an~     absence of reoperation for SUI during the follow-up period.~   "
155368|NCT01532570|"~     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650~     in patients with Behcet's disease ( BD ) with special lesions after the administration of~     TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to~     week 46.~   "
155369|NCT01532544|"~     This is an investigator sponsored double-blinded, multinational, multi center, randomized~     (2:1 active:placebo), placebo-controlled, phase IIa trial in severe pneumonia patients with~     severe sepsis or septic shock, investigating the safety and efficacy of co-administration of~     Iloprost and escalating doses of Eptifibatide for continuous intravenous infusion in totally~     36 patients.~   "
155370|NCT01532531|"~     Collateral meridian therapy (CMT) is a recently developed technique according to traditional~     Chinese medicine (TCM) experiences, differing from traditional Chinese acupuncture in~     numerous manners. CMT involves the manipulation of a distant non-painful collateral meridian,~     thereby facilitating the dissipation of pain. The technique avoids direct stimulation of the~     involved meridian, which enhances patient tolerability and prevents further injury to the~     disease and painful areas. Numerous clinical cases have reported the effectiveness of CMT in~     pain management. This study tests whether CMT is effective for treating knee OA pain and~     functional recovery.~   "
155371|NCT01532518|"~     The present pilot study is aimed to obtain preliminary data on the effect of three ascending~     oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance.~     In addition, the assessment of drug exposure (PK assessment) will provide additional~     information on the dose-effect relationship, thus supporting the dose selection and dosing~     schedule in the future studies.~   "
155372|NCT01532505|"~     The objective of this research is to compare the effect of a low dose Vasopressin infusion or~     placebo during cardiopulmonary bypass on vasopressor requirements, hemodynamics and tissue~     oxygen saturation and its recovery using tNIRS and vascular occlusion test (VOT) in elective~     on pump cardiac surgery patients using a non-invasive near infrared spectrometry (NIRS)~     machine. The clinical implications are that NIRS may permit earlier, non-invasive detection~     of significant physiologic derangements and allow more accurate and timely titration of~     medications, fluids and surgical intervention. The use of a low dose vasopressin seems to be~     preventive for the incidence of observed post-cardiotomy vasodilatory shock and may improve~     the function of microcirculation that will be assessed using VOT and tNIRS. Finally, it may~     decrease both catecholamine dose and duration of their administration, it is considered as a~     useful agent for decreasing all heir side-effects~   "
155373|NCT01532492|"~     Arthroscopic rotator cuff repair is described as being a successful procedure. These results~     are often derived from clinical general shoulder examinations, which are then classified as~     'excellent', 'good', 'fair' or 'poor'. However, the cut-off points for these classifications~     vary and sometimes modified scores are used.~      Arthroscopic rotator cuff repair is performed to improve quality of life. Therefore, disease~     specific health-related quality of life patient-administered questionnaires are needed. The~     WORC is a quality of life questionnaire designed for patients with disorders of the rotator~     cuff. The score is validated for rotator cuff disease, but not for rotator cuff repair~     specifically.~      The aim of this study is to investigate reliability, validity and responsiveness of WORC in~     patients undergoing arthroscopic rotator cuff repair.~   "
155398|NCT01532154|"~     This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with~     multiple sclerosis who have been exposed to prolonged-release fampridine since the first day~     of their last menstrual period prior to conception or at any time during pregnancy.~   "
155374|NCT01532479|"~     The purpose of this study is to determine if Hyperbaric Oxygen (HBO) therapy improves~     salivary gland function in previously head-and-neck irradiated patients. The following will~     be evaluated: salivary a-amylase, IGF-1, Thrombospondin-1, and VEGF-A concentrations, resting~     and stimulated salivary flow rate and pH, and salivary buffering capacity. Demographic data,~     past medical/surgical histories, social history and habits, risk factors, medication list,~     nutritional status, stage and location of tumor treated, dose/duration of radiation, and time~     elapsed since radiation treatment will be reviewed and recorded. Subjects will complete a~     quality of life questionnaire, describe (presence/absence) dry mouth symptoms prior to HBO~     therapy, and provide current A1c level, or submit to a finger stick. The following groups~     will be evaluated: 1. Head-and-neck irradiated subjects with ORN (indicating HBO therapy) 2.~     Subjects with other conditions indicating HBO therapy (positive control), and 3.~     Head-and-neck irradiated subjects without ORN (negative control). Subjects will include 78~     males or females, 18 years old and over. In total, participation will last 22 weeks.~   "
155375|NCT01532466|"~     An intravenous bolus of fentanyl often induces a cough reflex. This study investigates~     whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.~   "
155376|NCT01532453|"~     The purpose of this trial is to investigate the prevention of actinic keratoses and squamous~     cell carcinomas by local application of MD-3511356 in comparison to standard sun protection~     measures in immunosuppressed solid organ transplant recipients.~   "
155377|NCT01532427|"~     This is a post market surveillance registry to monitor the safety and performance of the~     ALFApump system.~   "
155378|NCT01532414|"~     The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and~     reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism~     (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with~     placebo. Subjects must not have previously been treated with testosterone products within the~     last 6 months.~   "
155379|NCT01532401|"~     The primary objective of this study is to analyze the sensitivity of blood pressure to oral~     salt intake. Matched male and female participants will be selected as normal weight,~     overweight, and obese.~      Participating subjects will have a first visit with blood pressure measurement and a blood~     sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6~     grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.~   "
155380|NCT01532388|"~     Objectives: This study compared the efficacy of eScreen in a two-armed randomized controlled~     design, measuring outcomes in terms of changes in problematic drug use up to one year after~     study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug~     use offers self-screening, in-depth self-reporting, personalized feedback and treatment~     recommendations as well as an electronic diary. Progress over time is shown in diagrams~     detailing consumption levels.~      Method: Participants with only problematic drug use according to the Drug Use Disorders~     Identification Test (DUDIT),(DUDIT >0 for both men and women) or both problematic alcohol use~     according to the Alcohol Use Disorders Identification Test (AUDIT), (AUDIT >7 for men and~     AUDIT >5 for women) and drug use were randomized to T1 (n=101) or the control group (n=101).~     Outcomes on alcohol and/or drug use as well as health-related symptoms were assessed after 3,~     6 and 12 months.~      Hypotheses that were tested in this study are 1) that both groups would reduce their drug~     consumption and drug-related problems at follow-ups compared to the baseline level and 2)~     that participants in the eScreen group would reduce their drug consumption and drug-related~     problems to a higher extent than participants in the control group (no intervention) at~     follow-ups.~   "
155381|NCT01532375|"~     With the epidemic of obesity and diabetes growing around the world, Kochujang (KCJ) may be~     potentially effective in preventing and treating obesity and cardiovascular risks if proven~     in humans. However, human trial still have not been reported with KCJ supplementation. In the~     present study, we investigated the hypothesis that KCJ supplementation can be decrease the~     body fat and improve blood lipid profiles in overweight adults.~   "
155382|NCT01532362|"~     The primary objective for this trial is to determine the biological ability of apricoxib to~     decrease T reg cells in the peripheral blood and tumor infiltrating lymphocytes in subjects~     compared to those who have not in subjects with early stage Non-small Cell Lung Cancer~     (NSCLC). The secondary objectives are to determine the efficacy of apricoxib to inhibit~     CD4+CD25+ T reg and FOXP3 function and exploration of COX-2 dependent biomarkers of apoptosis~     resistance, angiogenesis, invasion, and immunity.~   "
155383|NCT01532349|"~     This research is being done to study the effectiveness of vitamin D (cholecalciferol) to~     modify hepcidin levels in children with chronic kidney disease (CKD). Anemia is a common~     problem in children with CKD. Anemia is when the body does not have enough healthy red blood~     cells. Hepcidin is a protein in the blood which interferes with the body's production of red~     blood cells. This study will see if vitamin D lowers hepcidin levels in children and young~     adults with CKD. If so, it could be used as an additional treatment for anemia in these~     children, in addition to the current therapies already in use including iron supplements and~     erythropoietin. People between the ages of 1 and 21 with CKD may be considered for this~     study.~   "
155384|NCT01532336|"~     The purpose of this study is to evaluate the clinical and microbiological efficacy and safety~     of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of~     age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a~     positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening,~     Inc).~      Subjects will be randomly assigned to receive either NVC-422 or Vehicle.~   "
155394|NCT01532206|"~     Remote ischemic preconditioning has proven beneficial in patients undergoing percutaneous~     coronary intervention and coronary artery bypass surgery. Animal studies suggest remote~     ischemic preconditioning increases levels of interleukin 10. The investigators aim to~     determine whether remote ischemic preconditioning results in an increase in IL-10 levels in~     patients following acute myocardial infarction.~   "
155395|NCT01532193|"~     This study will determine whether the use of low oxygen tension during in vitro embryo~     culture may increase the pregnancy rates in women undergoing egg donation.~   "
155396|NCT01532180|"~     The objective of the study is to determine the safety and preliminary efficacy in patients~     utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).~   "
155385|NCT01532323|"~     In Human, the oral sphere is the first and main place where sensory stimuli are received and~     perceived. The phenomena occuring during food breakdown and sensory perception are complex~     and in this system saliva plays a major role.~      In the neonatal period, severe digestive diseases require the cessation of all oral feeding~     and the use of enteral or parenteral nutrition for prolonged periods to ensure the growth and~     development of children while their disease is active. The early stages of sensory oral~     exposures and their consequences on the development of eating habits of these children are~     poorly documented. It is likely that the process of acquisition of preferences and eating~     habits is atypical because of a bypass of the oral sphere during the early stages of~     feeding. Thus, if not orally fed, children do not get exposed to a wide variety of tastes and~     textures in the first year of life, which may impact on their oral acceptance at a later age.~     These oral disorders (OD) are expressed by a refusal to eat, a heightened gag reflex, a~     refusal of certain consistencies and difficulties in chewing and swallowing. Few data are~     available on food typically accepted by these children.~      Finally, oral sensory phenotypes of OD children (gustatory sensitivity ...) have not been~     described yet. It is likely that they may differ significantly from those of healthy (NOD).~      In this context, a population of OD children is particularly interesting for studying the~     effects of the absence of these learning stages and their consequences in the development of~     sensory perception and eating habits.~      The investigators formulate the hypothesis that the lack of exposure to a standard oral diet~     would modify the development of their oro-sensory systems including saliva.~      Studying such a population is a great opportunity to assess the influence of non oral food~     exposures and diet on saliva characteristics.~      Saliva has recently received attention as a potential easy to collect source of biomarkers in~     several conditions excluding OD.~      The potential impact of OD on salivary composition has never been studied. Several studies~     linking saliva and perception or preferences have been conducted in the UMR CSGA (Unité Mixte~     de Recherche du Centre des Sciences du Goût et de l'Alimentation). They have already~     contributed to highlight the great inter-individual variability for a number of saliva~     markers and a change in saliva protein profiles in response to taste stimulation They also~     underlined the remarkable intra-stability for saliva flow and composition during a one year~     study.~      This study intends to prove the concept that it is relevant to relate saliva characteristics~     to food intake behaviour or food habits The first hypothesis to be tested in this study is~     that salivary profiles (biological signatures) can discriminate two groups of children~     differing by their orality.~      The second hypothesis to be tested is that these specific biological biological signatures~     may be correlated to certain food habits associated or not with oral disorders.~   "
155386|NCT01532310|"~     This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and~     pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who~     have received commercially supplied belimumab within the 4 months prior to and/or during~     pregnancy. The registry will also evaluate outcomes of infants born to mothers who were~     exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will~     add to the current clinical experience with belimumab and will complement reproductive data~     from animal toxicology studies. It will also assist clinicians in weighing the potential~     risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline~     (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing~     Authorization.~   "
155387|NCT01532297|"~     Study investigating the safety and efficacy of the citrate dialysis solution compared to~     standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a~     clinically relevant development of adverse events. It is hypothesized that citrate dialysate~     may provide a local anticoagulation effect in the dialyser improving removal of uremic~     toxins.~   "
155388|NCT01532284|"~     A pragmatic, multicentre, randomized double-blind controlled trial with an intention-to-treat~     analysis, of the use of preimplantation genetic screening (PGS) for aneuploidy by means of~     microarray comparative genomic hybridization (CGH) for the chromosomal analysis of the polar~     bodies (PB) of oocytes collected after ovarian stimulation for in vitro fertilization (IVF),~     and with the intention to assess the genetic competence of oocytes of advanced biological~     age, and the effect of this technique on reproductive outcome.~   "
155389|NCT01532271|"~     The use of Event Related Potentials (ERP) and neurocognitive performance in patients~     following concussion has been examined previously in small cohorts and relatively long after~     concussion occurred. However, little is known about the immediate changes in brain activity~     in specific brain regions and connectivity across them associated with performance on~     specific neurocognitive tests following a concussion, and the subsequent changes over time.~     The proposed study will provide initial evidence for the feasibility of an ERP based~     biomarker for concussion reflecting temporal and spatial changes in brain activity as well as~     brain functional connectivity associated with concussion.~   "
155390|NCT01532258|"~     This research is examining whether an 8-week online nutritional programming based on a~     Mediterranean diet can achieve meaningful increase intake of a Mediterranean based diet and~     improvements in measures of body weight and laboratory measures of oxidative stress, a risk~     marker for cardiovascular disease. This study will also examine whether weekly short support~     and communication from a medical assistant (MA) in a primary care setting in addition to the~     online program will result in better program adherence and have a positive impact on health.~   "
155391|NCT01532245|"~     One method for treating intraoperative hypoxia during one-lung ventilation (OLV) is~     application of PEEP to the dependent lung. However, only a minority of patients benefit from~     this maneuver. The effect of applied PEEP on oxygenation depends on the relation between the~     total end-expiratory pressure and the lower inflexion point (LIP) of pressure-volume curve~     (1). LIP during OLV can be determined with super-syringe technique, but is too complicated~     for routine operating room use. An alternative is the constant-flow method which is easy and~     widely used in intensive care settings (2). The investigators goal was to confirm that the~     constant-flow method as applied by an intensive care ventilator works during OLV.~      Methods: After IRB approval and written, informed consent, data were obtained from 20~     patients during OLV for thoracic surgery who were ventilated with an AVEA (VIASYS Healthcare)~     critical-care ventilator. During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume~     was used. During OLV, ventilation periods of ten minutes, with and without 5 cmH2O PEEP were~     alternated. During each period, the investigators recorded arterial blood partial pressures,~     respiratory and hemodynamic values, intrinsic PEEP (PEEPi), and LIP. PEEPi and LIP were~     determined using the automatic mode of the ventilator; specifically, LIP was determined with~     a continuous flow of 3L/minute.~   "
155392|NCT01532232|"~     Breast cancer patients who smoke, are at greater risk for treatment complications. The~     purpose of this study is to see if the researchers can find ways to help patients who have~     breast cancer quit smoking. They will compare two ways to help people quit smoking. Some~     patients will receive varenicline, a prescription medicine also known as Chantix,®. Other~     patients will receive a placebo drug. A placebo is an inactive substance that contains no~     medicine. All patients will receive smoking cessation counseling provided by our tobacco~     treatment specialists. They hope that what the researchers learn from this study will help us~     improve our smoking cessation treatment program for breast cancer patients.~   "
155393|NCT01532219|"~     The overall aim of this study is to develop and test a psychodynamic Internet-delivered~     psychological treatment for patients with major depression and/or anxiety disorders and~     compare its efficacy to an active control group.~   "
155403|NCT01532089|"~     This randomized phase II trial studies how well erlotinib hydrochloride (Tarceva) with or~     without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung~     cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different~     ways by targeting certain cells. Bevacizumab may also stop the growth of NSCLC by blocking~     the growth of new blood vessels necessary for tumor growth. It is not yet known whether~     erlotinib hydrochloride is more effective when given alone or with bevacizumab in treating~     patients with NSCLC.~   "
155404|NCT01532076|"~     Failure rates of up to 30% are reported after proximal humeral fractures despite~     angular-stable devices. This may devastate not only the functional outcome but also the~     independence of elderly patients.~      To increase bone mineral density and thereby holding-strength augmentation is an option.~     Autologous bone-graft, as current gold-standard, though is questionable in osteoporosis since~     osteoprogenitors are dysfunctional and the harvesting-morbidity considerable. Adipose tissue~     seems an alternative cell-source even in presence of osteoporosis.~      Stromal vascular fraction (SVF) cells isolated from lipoaspirates display osteogenic and~     vasculogenic potential and can be harvested in high numbers. Expansion associated with costly~     good-manufacturers-practice facilities is avoidable, so are repeated interventions. These~     cells have been successfully used to generate osteogenic composite grafts with intrinsic~     vascularity in preclinical models.~      For translation into clinical practice after a 20 patient external pilot a prospective~     randomized controlled trial with 270 patients is planned. For the trial lipoaspiration~     precedes open reduction and internal fixation in individuals over 60 years presenting with a~     proximal humeral fracture after low-energy trauma. Cells are isolated (Cellution®800/CRS) and~     wrapped around hydroxyapatite microgranules after embedding in a fibrin-gel for augmentation~     of the typical bone-void. Clinical/radiological follow-up is at 6 and 12 weeks for immediate~     complications and after 6, 9 and 12 months. Functional assessment is performed after 6 weeks,~     6 and 12 months using the Quick-Dash- and Constant-Score.~      The primary outcome is a reduction in secondary dislocation by 50% during the first~     postoperative year. Secondary dislocation is diagnosed on plain radiographs by an independent~     board certified radiologist specialised in musculoskeletal imaging if one or more of the~     following criteria are met:~        -  More than 20° varus collapse of the humeral head fragment in relation to the humeral~          shaft~        -  Screw penetration through the humeral head~   "
155405|NCT01532063|"~     Difficult intubation is challenging in intensive care units. There are limited data regarding~     risk factors of difficult intubation in ICU. The primary purpose of the investigators study~     is to assess the risk factors of difficult airway in adults in ICU.~   "
155406|NCT01532050|"~     The present research intends to focus clinically on selecting the right type of patient for~     mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging~     and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy~     techniques with simulation of the mandibular repositioning. The core of the research project~     relies on known and established methods accepted in several neighboring fields, but aims at~     the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed~     biomedical research is directed towards clinical applications that incorporate innovative~     developments on the level of the diagnosis and therapy of a specific disease, being~     obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering~     objective compliance during MAD therapy.~   "
155407|NCT01532037|"~     The purpose of this study is to determine if cognitive behavioural therapy (CBT) based self~     help is effective for the management of symptoms of fatigue in Multiple Sclerosis (MS).~   "
155408|NCT01532024|"~     Seriously ill patients may develop a complication called acute lung injury (ALI), a form of~     inflammation in which lung tissue is filled by fluid containing white blood cells called~     neutrophils. ALI is common and is often fatal (for example in the USA it is estimated that~     190,000 patients develop ALI per annum, of whom 75,000 die). No pharmacological treatment has~     been shown to improve ALI.~      Data from animal models and patients strongly suggest that neutrophils are central to disease~     progression. However no bedside methods exist to rapidly and accurately determine in~     seriously ill patients, if neutrophils are present and if they are releasing damaging enzymes~     such as elastase. As such, the investigating team have developed and synthesised to clinical~     grade, an imaging agent called NAP (Neutrophil Activation Probe) that detects activated~     neutrophils and also the damaging enzyme, human neutrophil elastase (HNE). The investigators~     have extensively tested NAP in animal models for efficacy and safety. It reliably detects~     activated neutrophils and is not toxic.~      NAP is a small molecule that is delivered in tiny doses (called microdoses) to areas of~     inflammation in human lungs through a bronchoscope. The activity of NAP is visualised by~     imaging though a tiny camera that is also introduced through the bronchoscope. This camera~     system is now widely used throughout the world in over 150 sites.~      The investigators therefore aim to test the utility and safety of NAP in an exploratory~     clinical study. The study involves the delivery of NAP to 6 healthy volunteers followed by~     delivering NAP to 3 patients in ICU with pulmonary infiltrates and 6 patients known to have~     bronchiectasis.~      In the healthy volunteers study, healthy male volunteers recruited from the University of~     Edinburgh will be invited to participate.~      In the ICU study, patients will be recruited from the ICU in the Royal Infirmary of~     Edinburgh.~      In the bronchiectasis study, patients will be recruited from the respiratory service in NHS~     Lothian.~      If the study (which is supported by the Medical Research Council) demonstrates safety and~     also the ability to image activated neutrophils, the investigators intention is to design~     future studies in patients with ALI.~   "
155409|NCT01532011|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of erlotinib and pralatrexate that can be given to patients with advanced cancer.~     The safety of the drug combination will also be studied.~      Pralatrexate is designed to block the body's ability to make folic acid, a protein that may~     help cancer tissue to develop and spread.~      Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells~     to grow. Erlotinib may help slow the growth of tumors.~   "
155410|NCT01531998|"~     The goal of this clinical research study is to find the highest tolerable dose of Siltuximab~     that can be given in combination with Velcade (bortezomib), Revlimid (lenalidomide), and~     dexamethasone to patients with MM. The safety of this drug combination will also be studied.~   "
155411|NCT01531985|"~     The purpose of this study is to find out whether a combination of new urine tests and blood~     tests can show kidney injury in its early stages, before kidney failure sets in. If the~     investigators find new tests that show kidney injury in early stages, the investigators hope~     to start treating people with kidney injury earlier, to prevent kidney failure. You/your~     child are at higher risk for kidney injury and kidney failure than most other people, because~     of having operations with cardiopulmonary bypass (a machine that pumps your/your child's~     blood during the operation). This research is being done because there are no tests yet~     proven to show kidney injury before it leads to kidney failure.~      The urine and blood tests the investigators are studying have each been shown to indicate~     some degree of kidney injury in certain people, but not with the accuracy needed to diagnose~     disease. The investigators think that the combination of urine and blood tests being tried in~     this research study may provide enough information to better diagnose kidney injury at an~     earlier stage.~      About 20 persons over 2 years old up to adults will take part in this study. All will be from~     the Herma Heart Center of Children's Hospital of Wisconsin.~   "
155413|NCT01531959|"~     We hypothesize that midodrine treatment of refractory hypotension in patients otherwise ready~     for discharge from the ICU shortens duration of receiving IV vasopressors and SICU length of~     stay without increasing MGH length of stay or putting the patient at risk of being readmitted~     to an ICU.~   "
155414|NCT01531946|"~     The purpose of this study is to detect acute ischemic lesions in patients admitted with~     symptoms of transient ischemic attack (TIA).~      Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions~     after TIA. The problem is that this only gives the diagnosis in 30% of the cases.~      It is possible that the addition of Arterial spin labeling (ASL) perfusion imaging and~     diffusion tensor imaging will make it possible to give a more accurate diagnosis.~   "
155415|NCT01531933|"~     This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12~     weeks of therapy to investigate clinical efficacy and safety of DLBS3233.~      It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured~     by the improvement of prandial (particularly the first phase) insulin secretion as well as~     insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes~     into type 2 diabetes mellitus.~   "
155416|NCT01531920|"~     A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor~     function, and cognitive effects of perampanel when administered alone and with alcohol.~   "
155417|NCT01531907|"~     This study has been designed to study differences bone turnover in relation to glucagon-like~     peptide-2 (GLP-2) following feeding in lean and obese premenopausal women. Given the~     preliminary evidence that GLP-2 may act directly on osteoclasts, the investigators plan to~     determine whether GLP2 receptors are expressed in osteoclasts and the effect of GLP-2 on bone~     resorption.~      Hypotheses:~        1. Acute responses of GLP-2 and bone resorption markers following feeding are affected by~          body fat mass.~        2. Serum levels of GLP-2 are lower in obese pre-menopausal women and are associated with a~          reduction in trabecular and/or cortical bone mass~        3. GLP-2 has direct actions on osteoclast resorption via a functional receptor~   "
155418|NCT01531894|"~     GSK2110183 is an orally administered, pan-AKT kinase inhibitor that has demonstrated~     nonclinical activity in hematologic as well as solid tumor cell lines and xenograft models.~     In the First Time In Human (FTIH) trial, monotherapy with GSK2110183 dosed orally, once daily~     has shown encouraging activity in subjects with hematologic malignancies. This multicenter,~     non-randomized, open-label, treatment continuation or 'rollover' study is designed to provide~     continued access to eligible subjects who have previously participated in a GSK2110183 study~     (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on~     behalf of GSK. Eligible subjects must be receiving clinical benefit from continued treatment~     and have an acceptable safety profile with GSK2110183. Subjects who have participated in a~     GSK2110183 combination study with an approved anti-cancer agent will also be eligible to~     enroll in this rollover study. Subjects who participated in combination studies with two~     investigational compounds (one being GSK2110183) will not be eligible for this rollover~     study. Subjects will be enrolled by cohort based on the duration and treatment received while~     in their parent study. Safety assessments (physical examinations, vital sign measurements,~     12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical~     laboratory assessments and monitoring of adverse events) will be evaluated during this study.~     Disease assessment will be performed using local standard of care imaging practices and~     criteria appropriate for disease type and location.~   "
155419|NCT01531881|"~     This research may help dentists or surgeons to better detect areas in the mouth that are~     either prone to cancer or are early cancers. The earlier the detection on cancer in the~     mouth, the better the chance that treatment or prevention can be more effective.~   "
155420|NCT01531868|"~     Background: In a previous study, information verbally presented as relative risk (e.g. 50%~     less likely) or qualitative risk (e.g. significantly less likely) resulted in many more~     people (66%) choosing a surgical procedure for narrowing or artery in the neck than people~     presented with absolute risk (e.g. 11% versus 5% over 5 years), annualized risk (e.g. 2%~     versus 1% per year for 5 years) and event-free survival (e.g. 95% versus 89% over 5 years)~     (33%).~      Objectives: The purpose of this study is to determine whether the same observations are true~     for information that is presented visually as a bar graph. In addition, the investigators~     also seek to determine whether subjects feel that they understand the information better when~     presented visually as compared with verbally.~      Methods: 450 subjects will be approached in the neurology clinic as they are waiting for~     their office visit. If the subject agrees to participate in this 10 minute study, they will~     be taken to a quiet room where they will watch a 1 minute video on a laptop. The video will~     feature an acting physician. The presenter will be the same for all experiment groups. The~     presenter will describe a hypothetical medical situation in which a narrowing of one of the~     carotid (neck) arteries is present. The presenter will then describe the risk of a stroke~     related to that condition if the subject chooses medical therapy versus medical and surgical~     therapy. The presentation of risk will vary and may be presented in one of 3 different ways~     including a qualitative description, an absolute risk reduction over a fixed time period, and~     a relative risk reduction. These three risk groups will be presented either verbally or~     visually through bar graphs. In the visual subject groups, the presenter will be holding up a~     graph and remain silent while the graph is shown. The amount of time allotted for the graph~     on the video will be equal to the amount of time it takes the presenter to say the~     information in the auditory subject groups. Given that there will be 2 sensory modalities~     (verbal of visual) and 3 different presentation formats, there will be a total of 6 different~     videos. After the video is complete, the subject will be asked to complete a 1 page survey~     which will ask about the patient's age, gender, educational level, reason for the medical~     visit, and final decision about choice of treatment. The subjects will also answer how well~     they understood the data by making a mark on a 10 cm horizontal line.~   "
155421|NCT01531855|"~     The investigators hypothesise that reducing rapid-acting insulin dose after exercise will~     help prevent Type 1 diabetes individuals experiencing hypoglycaemia.~   "
155422|NCT01531842|"~     This is a research study to evaluate the effects of repeated intravitreal injections on~     bacteria around the eye.~   "
155423|NCT01531829|"~     In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue~     plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than~     the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is worthwhile to~     reveal whether low dose rt-PA plus low molecular weight heparin (LMWH) can rapidly reverses~     RV pressure overload in PE, but not increase bleeding and other adverse events. The aim of~     the study is to compare thrombolytic treatment with LMWH in patients with acute normotensive~     PE with right ventricular dysfunction(RVD).~   "
155474|NCT01531153|"~     Specific Aim #1: To determine if galantamine (8 or 16 mg/day) is more effective than placebo~     in reducing cocaine use as measured by cocaine urine results and self-report days of use.~      Specific Aim # 2: To determine if galantamine (8 or 16 mg/day) is more effective than placebo~     in improving attention, assessed with the Rapid Visual Information Processing (RVIP) and the~     Simple Reaction Time (SRT) tests Specific Aim # 3: To determine if improvement in attention~     during the first four weeks of treatment will mediate galantamine's efficacy in reducing~     cocaine use.~   "
155424|NCT01531816|"~     Critically ill patients are often confined to bedrest, because of the nature of their~     illness. However, it has now been shown that prolonged bedrest and immobility, particularly~     in critically ill adults and children, can lead to serious outcomes such as muscle weakness~     and prolonged stay in the intensive care unit (ICU). Research in adults has demonstrated that~     preventing immobility and introducing exercise and rehabilitation in adult patients early~     during their ICU illness can prevent these serious outcomes, reduce the duration of hospital~     stay, and enhance their recovery after they leave the ICU. The purpose of our research is to~     investigate if early mobilization and rehabilitation can also be performed in critically ill~     children, and eventually evaluate this results in beneficial outcomes in these children, as~     it has been shown to be in adults. However, given that children are not the same as adults,~     but have varying abilities to understand and participate in activities when they are sick,~     the investigators first have to evaluate the most appropriate and safe ways of helping~     children exercise while they are in the ICU. This objective of this study is to evaluate if~     2 methods of rehabilitation (a stationary bike and interactive video game) can be implemented~     in critically ill children. These methods have been used in hospitalized children and in~     critically ill adults. The investigators will evaluate if these methods are safe for~     critically ill children.~   "
155425|NCT01531803|"~     This is a randomized, controlled, open-label clinical trial to be conducted at approximately~     12 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of~     22 months, with 6 months for trial set-up, 12 months of simultaneous subject enrollment and~     30 days of treatment/follow-up period, and 3 months for study close-out.~      The study population will consist of at least 60 male and female pediatric subjects between 0~     days and 12 years of age, undergoing cardiac, abdominal, orthopedic or transplant surgery~     with an approximately equal number of subjects (n=10 to 25) in three of the four age groups:~     (29 days to 23 months), (2 to 5 years 11 months) and (6 years to 12 years) cohorts.~      Regarding the youngest age group of 0 to 28 days, the minimum number of patients to be~     enrolled in the study will not be predefined as very a small number of elective surgical~     procedures is expected in this population.~      Safety concerns and eventual safety signals, as well as recruitment rate, will be monitored~     annually (starting from the enrollment of the 60th subject) by an independent Safety~     Monitoring Board (SMB), which will be appointed prior to study initiation and submitted to~     the FDA. The responsibilities of the SMB will be defined in ad hoc document, in which the~     threshold for acceptable safety will also be set.~      During the conduct of the study on the first 60 patients, if there is any safety signal~     linked to the primary safety endpoint (i.e. pulmonary fluid overload) or imbalance in the~     incidence of AEs between the treatment and control groups or based on relevant literature, as~     judged by the SMB, the enrolment will be increased to 100 patients using the same age~     stratification approach defined above (n=20 to 30 in each age group).~      Potential subjects will be pre-screened and informed consent/assent will be obtained from the~     subject and/or subject's parents or guardians prior to surgery. Post-surgery, the subject~     will be admitted to the Surgical, Neonatal, or Pediatric Intensive Care Unit (SICU/NICU/PICU)~     for postoperative recovery and care management. Subjects who show signs of hypovolemia as~     judged by the Principal Investigator (PI) will be screened to determine their eligibility to~     participate in this trial. Subjects will then be randomized to receive treatment with~     Kedbumin 25% or the comparator, normal saline (sodium chloride 0.9%).~      There is no specific post-treatment regimen for this protocol, as all subjects will receive~     the standard post-operative care based on their clinical status and response to treatment at~     the discretion of the Investigator.~      Vital signs and fluid management/replacement therapy recorded in the medical chart and~     results of standard complete blood count (CBC), biochemistry, and hematology and coagulation~     lab panels will be reviewed and recorded by research staff at specified time points,~     according to the hospital standard of care. Additionally, research staff will review and~     record daily lactate, urine albumin, blood urea nitrogen (BUN), creatinine, and non-invasive~     measurements at the following time points: Baseline, 6hr, 12hr, 24hr, 36hr, 48hr, and 72hr~     post-onset of hypovolemia), until hemodynamic stability is achieved. Hemodynamic stability~     will be evaluated based on site-specific age-defined reference ranges for heart rate, blood~     pressure, urine output, and cardiac index in children.~      The volume, rate and frequency of the Investigational Medicinal Product (IMP, either Kedbumin~     25% or normal saline) administered will be recorded in addition to the type, timing, and~     amount of all other fluids administered. The time to hemodynamic stability, duration of~     stability once attained, and any relapse requiring additional treatment or use of secondary~     resuscitation strategies will be recorded. Subjects who demonstrate hemodynamic stability~     within 3 days after treatment initiation and then relapse into hemodynamic instability as a~     result of surgical complications or infection will exit from the study, but the data be~     considered for the safety analysis. These subjects should continue treatment according the~     clinical practice standard since the study is not intended to evaluate the efficacy of~     Kedbumin 25%.~   "
155426|NCT01531790|"~     This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of~     continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced~     non small cell lung cancer (NSCLC) patients.~   "
155427|NCT01531777|"~     RATIONALE:~      Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor~     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The~     investigators' phase I study has shown that the drug's toxicity is manageable.~      PURPOSE:~        1. Studying how well Apatinib works in treating patients.~        2. Finding the efficacy and safety of 500 mg or 750mg Apatinib.~        3. Pharmacokinetics/Pharmacodynamics(PK/PD).~        4. Exploring new outcome measures of antiangiogenic drugs.~   "
155428|NCT01531764|"~     This open-label, single-arm, multicentre phase II trial will be performed in patients with~     intermediate HER2-positive, metastatic breast cancer (MBC)pretreated with anthracyclines and~     one first-line therapy in the metastatic setting.~      The main objective of the trial is to evaluate the efficacy and safety of BIBW 2992 in~     combination with vinorelbine in patients with intermediate HER2-positive MBC. If this trial~     shows promising results, further studies to evaluate the benefit of BIBW 2992 in combination~     with chemotherapy in this subgroup of intermediate HER2-positive patients with MBC are~     warranted.~      Patients will be followed until progression. After progression, for the purpose of analysing~     overall survival, information on vital status and subsequent treatment will be collected.~      The primary objective is to determine the 6-month progression free survival rate of BIBW 2992~     and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative breast~     cancer.~      BIBW 2992 in combination with vinorelbine will provide a suitable combination to test the~     hypothesis that patients with metastatic breast cancer whose tumours are HER2 2+ by~     immunohistochemistry, but negative by fluorescence in-situ hybridisation (FISH) will benefit~     from a combination of a cytotoxic agent, i.e. vinorelbine, plus the dual irreversible~     EGFR/HER2-tyrosine kinase inhibitor BIBW 2992.~   "
155429|NCT01531751|"~     The aim of the study is to assess survival of patients with advanced cardiac AL amyloidosis~     treated with high cut-off hemodialysis (HCO-HD) combined with chemotherapy.~   "
155430|NCT01531738|"~     The investigators hypothesize that some of these changes in the reduced appetite after~     surgery may be due to alterations in taste. The aim is to compare obese patients before and~     after bariatric surgery (gastric bypass and banding) to define the reward value of sweet,~     fatty and vegetable/fruit taste in obese individuals, and how this changes after surgery.~   "
155431|NCT01531725|"~     The primary objective of this study is to evaluate safety and efficacy of the BIOTRONIK~     PRO-Kinetic coronary CoCr-stent in patients with single de novo lesions of native coronary~     arteries.~   "
155432|NCT01531712|"~     Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by~     chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with~     borderline resectability. The primary objective is to determine the resectability rate of~     patients with pancreas adenocarcinoma with borderline resectability determined~     radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy~     with Gemcitabine and Tarceva.~   "
155433|NCT01531699|"~     This is an open-label, randomized, single-dose, placebo-controlled efficacy study to assess~     the antimicrobial efficacy of ALT005 ophthalmic prep solution following dermal administration~     in healthy volunteers. Efficacy will be assessed by comparing the reduction in microbial load~     for up to 6 hours to that of saline control.~   "
155434|NCT01531686|"~     Intraosseous vascular access can be used to effectively and safely deliver contrast dye for~     CT examination.~   "
155435|NCT01531673|"~     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and~     pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in~     participants with cystic fibrosis (CF) who are homozygous or heterozygous for the~     F508del-CFTR mutation.~   "
155436|NCT01531660|"~     Background: Inactive individuals face motivational obstacles for becoming and staying~     physically active. Therefore, sustainable physical activity promotion programs tailored to~     reach inactive individuals are needed.~      Purpose: to test the effect (long and short-term) and feasibility of a training program and~     to evaluate the association between the baseline motivation to become physical activity and~     the change in physical activity and performance.~      Design: uncontrolled trail Setting/participants: inactive, female hospital staff aged 45 and~     older from the University Hospital Zurich Intervention: 3-month step-up jogging program Main~     outcome measures: physical performance and level of physical activity~   "
155437|NCT01531647|"~     This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug~     interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers.~     Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days,~     danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days~     18-21.~   "
172214|NCT01311024|"~     The purpose of this study is to assess the indirect effects of a pneumococcal conjugate~     vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7~     years.~   "
155438|NCT01531634|"~     The field of psychiatric rehabilitation focuses on creating a personal narrative and~     developing coping strategies and environmental supports. The concept of recovery is~     person-centered and emphasizes the person's ability to change and to live meaningful life.~     The strengths approach has a central role in the recovery concept, emphasizing the person's~     abilities and potential. A preserved cognitive ability can be a significant strength in the~     recovery process.~      Research had shown growing support for the use of cognitive-behavioral approaches as the most~     effective therapy for people with borderline personality disorder, using structured~     interventions. A central focus in cognitive therapy is the change of maladaptive schemes. The~     dynamic-cognitive intervention (DCI) is based on the understanding of structural cognitive~     modifiability and suggests the use of mediated learning in order to enhance sense of~     competence and develop better psychological coping skills.~      The present study will focus on women diagnosed with borderline personality disorder, with~     normative cognitive ability seen as a strength as opposed to their emotional ability. This~     study will examine the effects of a Dynamic Cognitive Intervention on recovery measures and~     on symptoms severity.~      The study will include 30 women aged 18-45 years. Participants will be randomly assigned to~     an intervention group and a control group. All participants will be assessed before and after~     intervention using Recovery Assessment Scale, Hope Scale and The Brief Symptom Inventory.~      The intervention designed for this study is based on the principles of the Dynamic Cognitive~     Intervention. The intervention tools that will be used include: a. Instrumental Enrichment~     tools. b. life events analysis. c. Stories, lyrics and movie clips. d. Worksheets. The~     intervention encompasses 12 sessions of 1.5 hours, with a routine structure.~      The results are expected to contribute to the understanding of the impact of a dynamic~     cognitive intervention in women diagnosed with borderline personality disorder.~   "
155439|NCT01531621|"~     -  A population-based prospective study to evaluate clinical behaviour, resectability and~          survival in 1st line metastatic colorectal cancer (CRC) patients in Finland~        -  Primary objective: To assess clinical behaviour of metastatic colorectal cancer and~          overall resectability, postoperative morbidity and outcomes after resection~        -  Secondary objectives: To assess treatments for mCRC; To assess efficacy of chemotherapy~          and targeted drugs with overall response rates (ORR), failure free survival (FFS),~          progression free survival (PFS), and overall survival (OS); To radiologically assess~          tumour density and morphology, and assess alternative radiologic response evaluation in~          comparison with RECIST response criteria; To evaluate whole blood, plasma, serum and~          tumour block biomarkers and DNA polymorphisms that may predict drug effects,~          resectability and clinical behaviour of the tumour~   "
155440|NCT01531608|"~     This is a single-institution study seeking to evaluate if mobile gamma camera imaging can be~     used independent of standard fixed gamma camera imaging in patients undergoing sentinel node~     biopsy for melanoma.~   "
155441|NCT01531595|"~     -  Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with~          alternating Xeliri and Xelox as first-line treatment of patients with metastatic~          colorectal cancer.~        -  Primary objective: PFS, To assess overall resectability in patients with metastatic~          colorectal cancer, postoperative morbidity and outcomes after resection.~        -  Secondary objectives: To assess response rates according to RECIST criteria, failure~          free survival (TTF) and overall survival (OS), Quality of life according to 15D~          questionnaire, To radiologically assess tumour density and morphology, and assess~          alternative radiologic response evaluation in comparison with RECIST response criteria,~          Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms~          that may predict drug effects, safety, resectability and clinical behaviour of the~          tumour~   "
155442|NCT01531582|"~     There is mounting evidence to suggest that a treatment for Angelman syndrome is not just~     possible, but probable. The lack of known molecular targets associated with AS has hampered~     the development of specific therapeutics. However, a recent surge of potential therapeutics~     for other disorders associated with cognitive disruption has begun to be used in human~     clinical trials. The molecular modes of action for many of these new therapeutic agents have~     correlates to counter the molecular defects observed in AS. One such agent is minocycline~     (MC), a drug traditionally used as an antibiotic. This compound administered to a mouse model~     of AS showed a significant decrease in motor deficit and an increase in long term~     potentiation. The investigators believe a similar result will be observed when minocycline is~     administered to the AS patient and may lead to the development of an effective AS~     therapeutic.~   "
155443|NCT01531569|"~     This study is being done to look at age differences in the way the investigators bodies break~     down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is~     administered to research subjects in a product called BeneFlax, which a concentrated version~     of flax seed containing 38% SDG.~      It is known that as people age, their bodies undergo physical changes both on the outside and~     the inside. The aging process may change the way that the investigators bodies deal with~     compounds the investigators eat. As an important measure of safety, the investigators want to~     check for evidence whether there is a difference in break down of SDG between different age~     groups.~   "
155444|NCT01531556|"~     Honey available in New Zealand can contain the toxins tutin and hyenanchin. Tutin is produced~     by several plants native to New Zealand. Bees collect honeydew contaminated with tutin and~     hyenanchin for honey production.~      Honey contaminated with high levels of tutin has caused cases of poisoning in New Zealand~     since the 1800s, with the most recent outbreak in 2008.~      The study aims to find out how tutin and hyenanchin are absorbed and processed by the body.~     This information will help the Food Standards Australia New Zealand (FSANZ) give guidance on~     acceptable levels of tutin and hyenanchin in honey.~      About 6 healthy men will each take a single dose of honey containing known concentrations of~     tutin and hyenanchin.~      This dose level is similar to what someone who eats a lot of honey would consume, if the~     honey contained the maximum level of tutin allowed under the Food Standards Code.~      Blood tests to measure tutin and hyenanchin levels will be taken at certain times after~     dosing, and any side effects will be recorded.~   "
155472|NCT01531179|"~     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal~     system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in~     newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other~     lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in~     clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing~     enterocolitis in very low birth weight infants yet. The objective of this study is to~     evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence~     and severity of necrotizing enterocolitis in very low birth weight infants.~   "
155600|NCT01529502|"~     The purpose of this study is to determine whether storage time affects how human body~     responds to autologous blood transfusion. An autologous blood transfusion is when a person~     donates blood and then receives that same blood back in the transfusion. We also want to find~     out if in this situation inhaled nitric oxide can help to prevent the potential reduction of~     vasodilation capacity. Vasodilation capacity is the ability of the blood vessel to widen when~     needed.~   "
155445|NCT01531543|"~     The aim of the project was to optimalize the process in severe peritonitis which is generally~     inflicted with high mortality and morbidity with long term costly therapy. Therapy of severe~     intraabdominal infection consist of treatment of the infection site and following closure of~     the abdominal cavity with possibility of re-laparotomy and in treatment of complications when~     needed; or closure introduction of laparostomy with intention to control complications~     prevention however with risk of tertiary peritonitis. Modern process is laparostomy with~     active suction (VAC) method which reduces the risk of tertiary peritonitis. It efficacy is~     however approved especially in therapy of complications. Based on the investigators~     experiences the investigators use this method even in case of primary treatment of severe~     peritonitis which led to protocol processing (VAC in case of primary closure of the abdominal~     cavity; VAC exchange according to scoring system; secondary closure of the abdominal cavity~     or early coverage with collagen mesh). The aim of this project is to prove reduced mortality,~     morbidity and hospitalization length (cost reduction) in prospective randomized study in~     patients treated due to severe peritonitis using VAC method in comparison to classical~     approach (primary closure of the abdominal cavity; secondary solution of complications).~   "
155446|NCT01531530|"~     The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral~     vaccine) is safe and effective in the prevention of Shigella infection.~   "
155447|NCT01531517|"~     Clinical Trial Phase III-b~      Study Sponsor:~      European Egyptian Pharmaceutical Industries~      Sample Size:~      120 patients (60 per arm)~      Study Population:~      Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if needed.~     Those patients will be recruited from patients attending the Diabetic foot Center at Faculty~     of Medicine - Alexandria University and the outpatient clinic at Faculty of Medicine, Cairo~     University.~      Recruitment Period: 9 months~      Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the~     ulcer.~      Endpoints: Complete healing of the ulcer OR 5 months of application of the ointment whichever~     comes first~   "
155448|NCT01531504|"~     Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites~   "
155449|NCT01531491|"~     Hypercapnia derives increase of cerebral blood flow and cardiac output. It means that the~     rate of propofol elimination from the brain and the blood will be increased and the patient~     will awake more quickly. There has been no study about the effects of hypercapnia. The~     investigators will evaluate hypercapnia's effects on the recovery time from propofol~     anesthesia.~   "
155450|NCT01531478|"~     Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of~     850 French persons has survived childhood cancer. However, the complications of chemotherapy,~     radiotherapy or surgery can lead to a higher risk of secondary mortality, which the~     literature estimates is at 14%. Regular care has a positive impact on the quality of life and~     health of adults who survived cancer during their childhoods. It aims to detect the potential~     long-lasting effects of cancer and to provide therapeutic education and psychological care.~     Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands)~     have developed long-term care structures which function with specially trained adult medicine~     practitioners. There are only two structures in France: the Long-Term Oncology/Hematology~     Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the~     follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France,~     which began in 2003 and has since been extended to other centers.~      The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they~     compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary~     trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed~     the correlation between patients' quality of life and the long-term medical effect of cancer~     and treatment, both recorded in patients' medical files and declared by patients. These young~     adults who survived pediatric cancer appear to suffer from and declare many complications,~     although this does not impact their global quality of life much. There is a negative~     correlation between the number of complications (observed or declared) and the global quality~     of life score, but only three types of complications play a significant role (motor function~     complications, auditory complications, and alopecia.) In addition, there is a significant~     mismatch between patients's perceived health (what they say they experience), and the~     information contained in their medical files. These young adults expressed the need for their~     impressions to be better taken into account by health care professionals. This study does not~     assess patients' psychopathological characteristics.~   "
155451|NCT01531465|"~     The purpose of this study is to compare two common methods of providing respiratory support:~     nasal continuous airway pressure and high flow nasal cannula to see what effect it has on~     babies breathing. The investigators also will compare the effects of slightly changing the~     level of support these two different types of therapy on how easily your baby is breathing.~     Changes in the level of support and between these two respiratory support modalities are~     frequently done and are part of the routine care in the neonatal intensive care unit.~   "
155452|NCT01531452|"~     The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as~     first-line treatment of advanced gastric cancer.~   "
155453|NCT01531439|"~     There will be two groups in this study: one group will be given the standard infusion of~     naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the~     other group will receive a higher dose. The trial is designed to determine if a higher dose~     of naloxone infusion will reduce side effects from opioid therapy in patients who have~     undergone spine fusion for scoliosis.~   "
155454|NCT01531426|"~     Data indicate that neurological prognostication is difficult after cardiac arrest if mild~     therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation detected~     by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome~     assessment after cardiac arrest. The investigators hypothesize that cardiac arrest survivors~     with a continuously low cerebral oxygenation index have a poor prognosis.~   "
155455|NCT01531413|"~     Oxygen has inherent bactericidal properties. The investigators are testing to see if they can~     reduce the incidence of postoperative abscesses following laparoscopic appendectomy by~     insufflating with oxygen at the end of the case.~   "
155456|NCT01531400|"~     The investigators hypothesized that self-selected music played during electrodiagnosis is~     effective in relieving the discomfort caused by the procedures.~   "
155457|NCT01531387|"~     The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy~     (hydroxyurea) to standard care (observation) in children with sickle cell anemia and~     conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative~     regimen (hydroxyurea) to be declared superior to the standard treatment regimen~     (observation), the hydroxyurea-treated group must have a three-fold reduction in the~     incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard~     treatment arm.~   "
155458|NCT01531374|"~     The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve®~     System in the treatment of symptomatic severe aortic stenosis in subjects who have a~     predicted very high risk and high risk for aortic valve surgery.~   "
155459|NCT01531361|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of ZelborafTM (vemurafenib) with Nexavar® (sorafenib) or Xalkori® (crizotinib)~     that can be given to patients with advanced cancer. The safety of these drugs will also be~     studied.~      Vemurafenib is designed to block a protein called BRAFV600E inside the cancer cells, which is~     involved in cancer cell growth.~      Sorafenib is designed to block the function of important proteins in and outside of cancer~     cells. These proteins are involved in cancer cells growth and new blood vessel development.~      Crizotinib is designed to block certain abnormal genes found in cancer cells. This may cause~     the cancer cells to die.~      This is an investigational study. Vemurafenib is FDA approved and commercially available to~     treat progressive melanoma with the BRAFV600E mutation. Sorafenib is FDA approved and~     commercially available to treat progressive hepatocellular carcinoma and renal cell~     carcinoma. Crizotinib is FDA approved and commercially available to treat locally advanced or~     metastatic non-small lung cancer. Giving the combination of vemurafenib either with sorafenib~     or crizotinib to patients with advanced cancer is investigational.~      Up to 183 patients will be enrolled in this study. All will be enrolled at MD Anderson.~   "
155460|NCT01531348|"~     The purpose of this study is to determine the feasibility and safety of adult human bone~     marrow-derived mesenchymal stem cells by intravitreal injection in patients with retinitis~     pigmentosa.~   "
155461|NCT01531335|"~     The aim of this study is to compare two nutritional regimes in critically ill patients.~     Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15~     kcal per kg). The main outcome will be the SOFA (sequential organ failure assessment) score.~     The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic~     failure in these patients.~   "
155462|NCT01531322|"~     This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal~     Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese~     adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then~     infants aged approximately 2 months.~   "
155463|NCT01531309|"~     Agomelatine (AGO178) was developed for the treatment of depression. A new formulation is~     being tested in the present study: a tablet to be placed and dissolved under the tongue~     (sublingual tablet). The goal of this trial is to study the pharmacokinetics of agomelatine~     given as sublingual tablet in patients with liver impairment and to compare the results to~     those of healthy volunteers who receive the same treatment.~   "
155464|NCT01531296|"~     Determining the investigators ability to accurately assess rotational malalignment clinically~     compared to imaging.~   "
155465|NCT01531283|"~     Use of human unacylated ghrelin (UAG, also called des-octanoyl ghrelin) to study physiology~     in healthy subjects. The proposed research is an investigator-initiated study funded by the~     National Institutes of Health designed to examine the effect of physiologic levels of UAG on~     the regulation of glucose homeostasis as well as beta cell function.~   "
155466|NCT01531257|"~     Chronic Allograft Nephropathy (CAN)/Interstitial fibrosis and Tubular Atrophy (IFTA) is~     responsible for most kidney transplant failures. CAN/IFTA on a 3 month kidney biopsy strongly~     predicts graft survival long term. CAN/IFTA remains a vexing problem for clinicians because~     current monitoring tools, namely the serum creatinine concentration, are not sensitive to~     early changes in glomerular filtration rate (GFR) or to histologic damage.~      Despite advances in prevention of acute rejection (AR), it is still a significant and~     potentially devastating complication of solid organ transplantation. One strategy to reduce~     the risk of rejection is to perform kidney biopsies to detect subclinical acute rejection~     (SCAR) and treat to prevent progression to rejection. There is evidence that treating SCAR~     can prevent further immune mediated injury to the kidney, a precursor to CAN/IFTA.~      Kidney biopsies provide better information but are limited due to safety concerns, patient~     preference and cost issues. Better, early and less invasive markers of CAN/IFTA will allow~     early intervention as well as improved graft and better patient outcomes.~      This study seeks to validate specific proteogenomic biomarker panels for AR and CAN/IFTA in a~     prospective blood, urine and kidney tissue monitoring study of kidney transplant recipients~     who will be scheduled for standard of care biopsies.~   "
155467|NCT01531244|"~     This phase I/II trial studies the safety, best dose and effectiveness of targeted gene~     therapy combined with isolated limb infusion (ILI) of melphalan and dactinomycin for treating~     patients with advanced extremity melanoma that cannot be removed by surgery. Adding gene~     therapy to a standard chemotherapy regimen in the isolated limb may enhance anti-cancer~     effects by inducing a systemic immune response against the tumor cells.~   "
155468|NCT01531231|"~     The purpose of this study is to examine the role of every day experiences as they relate to~     coronary artery disease (CAD).~   "
155469|NCT01531218|"~     A randomized, double-blind, placebo-controlled clinical trial of azithromycin in~     Campylobacter concisus culture positive patients with diarrhea. The clinical characteristics~     of emerging Campylobacter concisus in adults is vomiting and persistent diarrhea. Whether~     patients may benefit from antibiotic treatment is unknown. The purpose of this trial is to~     investigate whether antibiotic treatment with azithromycin of Campylobacter concisus induced~     diarrhea can better the symptoms and shorten the duration of illness.~   "
155470|NCT01531205|"~     The aim of this study is to test whether adding chemotherapy/cabazitaxel and~     hormonal/androgen deprivation therapy before surgical removal of your prostate would improve~     the outcome of salvage surgery for locally recurrent prostate cancer after the initial~     primary radiation therapy.~   "
155471|NCT01531192|"~     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal~     system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida~     colonization. The objective of this study is to evaluate the efficacy of prophylactic~     Lactobacillus reuteri in reducing the candida colonization and infection in very low birth~     weight infants.~   "
155473|NCT01531166|"~     The current proposed study aims to bring answers following issues: the antiviral efficacy and~     safety profiles in Korean Chronic Hepatitis B (CHB) patients who are mostly infected with~     solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability or~     accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease~     progression to liver cirrhosis and liver cancer. In addition, this study aims to collect more~     data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in~     patients with CHB.~   "
155475|NCT01531140|"~     Background:~      Polyethylene glycol (PEG) solution has been proven to be effective for large bowel cleansing~     prior to colonoscopy in children. However, the high volume of fluid and its taste sometimes~     lead to inappropriate cleansing of the bowel, thus search for other bowel preparation is~     needed.~      Aim:~      The efficacy and tolerability of three different bowel cleansing protocols used in children~     for colonoscopy: high-volume PEG compared with low-volume PEG with stimulant laxative~     (bisacodyl) compared with sennosides.~      Methods:~      Participants aged 10-18 years will be randomly assigned to receive either PEG 60 ml/kg/day or~     PEG 30 ml/kg/day plus oral bisacodyl 10-15 mg/day or sennosides 2mg/kg/day for 2 days prior~     to the colonoscopy. The outcome measures will be:bowel cleansing efficacy, scored by a~     blinded endoscopist using the Ottawa scale and Aronchick Scale (the mean total score,~     proportions of participants with excellent/good and with poor/inadequate bowel preparation),~     and the patient satisfaction score(0-10)with the method of preparation for the colonoscopy~     evaluated with the visual analog scale. Analysis will be done on an intention to treat basis.~   "
155476|NCT01531127|"~     The purpose of this study is to determine whether there is a difference in executive function~     in learning in children with ADHD receiving medical treatment alone to the executive function~     in children receiving, in addition to medical treatment in learning strategies.~   "
155477|NCT01531114|"~     Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial~     infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent~     implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI~     undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in~     terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg)~     in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug~     administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study~     drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI~     with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD~     administration. All patients must will be naïve for platelet P2Y12 receptor inhibition~     therapy. A subanalysis will be performed between two study groups according to insulin~     treatment.~   "
155478|NCT01531101|"~     The First Experimental Study on Transference work - In Teenagers (FEST-IT) will be a~     randomized clinical trial, which will be designed to explore effects of transference work in~     dynamic psychotherapy in adolescents with major depressive disorder (MDD). The design of the~     study is a so-called dismantling design, in which a single component is added and/or varied~     to an existent treatment method (psychodynamic psychotherapy). Thus, the efficiency of a~     specific technique (transference interventions) can be identified.~      The primary hypothesis is that the transference group may have a more favorable course over~     time than will the comparison group.~      The second hypothesis is that patients with a history of low Quality of Object Relations~     score and/or personality disorders—might benefit more from therapy with transference work~     than from therapy without.~      The third hypothesis is that female adolescents may have better treatment effect of~     transference work than male adolescents.~   "
155479|NCT01531088|"~     Adverse drug events (ADEs) are the most clinically significant and costly medication-related~     problems in nursing homes (NH) and are associated with an estimated 93,000 deaths a year and~     as much as $4 billion of excess healthcare expenditures. Current ADE detection and management~     strategies that rely on pharmacist retrospective chart reviews (i.e., usual care) are~     inadequate. Active medication monitoring systems are recommended by many safety organizations~     as an alternative to detect and manage ADEs. These systems have been shown to be less~     expensive, faster, and identify ADEs not normally detected by clinicians in the hospital~     setting. The investigators developed and pilot-tested an active medication monitoring system~     for use in a single NH, where it was shown to detect ADEs with a high degree of accuracy and~     at a rate of nearly 2.5 times that of usual care. The long-term objective of our proposed~     research is to improve patient safety with respect to medications in NHs. The short-term~     objectives or specific aims of our proposed research are to determine if NH patients managed~     by physicians who receive active medication monitoring alerts have more ADEs detected, have a~     faster ADE management response time, and can result in more cost-savings from a societal~     perspective compared to usual care.~   "
155480|NCT01531075|"~     The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of~     IBD patients treated with immunosuppressive medications.~   "
155481|NCT01531062|"~     The purpose of this study is to determine whether Nigella sativa seed extracts are effective~     in the treatment of dyslipidemia in elderly.~   "
155482|NCT01531049|"~     The purpose of this study is to assess the efficacy and effectiveness of varenicline and~     nicotine patch combined with motivational interview technique in smoking cessation of young~     adults over 12 months follow-up.~   "
155483|NCT01531036|"~     Breast Ultrasound Elastography is a complementary technique permitting a better~     characterization of breast lesions. 3D breast ultrasound elastography is a novel technique~     permitting a volumetric calculation of lesion stiffness. This could be particularly useful in~     patients with large breast tumors under pre-operative chemotherapy~   "
155484|NCT01531023|"~     The prevalence of extended spectrum beta-lactamase (ESBL) producing bacteria found in urine~     sample cultures has been increasing over the past decades.~      The study hypothesis is to assess the clinical and microbiological outcome of pivmecillinam~     treatment of ESBL producing E. coli and K. Pneumoni, as well as to observe the clinical and~     microbiological outcome of the same group of bacteria treated with other antiinfectious~     agents.~      Samples are gathered in primary care setting.~   "
155485|NCT01531010|"~     Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for~     preterm infants in comparison to pressure-limited ventilation. This study aims to compare~     pressure-limited to VTV in preterm infants.~      Hypothesis: Volume-targeted will be associated with more rapid achievement of weaning~     criteria compared to pressure-limited ventilation~      Primary outcome: Time taken to achieve pre-specified weaning criteria.~      Methods: Ventilated infants less than 34 weeks gestational age at birth were recruited within~     the first 24 hours of life and randomly allocated to receive either pressure-limited or VTV.~     Adjustments to ventilator settings were made according to the trial protocol. Infants were~     deemed to have met failure criteria if they required HFOV, required peak pressures of more~     than 26 cm of water or developed pulmonary haemorrhage. Analysis will be by~     intention-to-treat.~   "
155486|NCT01530997|"~     The purpose of this research study is to learn about the effectiveness of using~     lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated~     low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck.~     The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment~     for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is~     performed afterwards. This standard regimen causes a lot of side effects and long term~     complications. This study is evaluating whether a lower dose of radiation and chemotherapy~     may provide a similar cure rate as the longer, more intensive standard regimen. Patients in~     this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy~     followed by a limited surgical evaluation.~   "
155487|NCT01530984|"~     This is an open-label randomized phase II study. Patients are randomized so as to achieve~     uniform patient cohorts treated on each regimen. Twenty-seven patients will be required per~     treatment arm, and a total of 54 prostate cancer patients will be required to complete this~     study. The study will assess for clinical activity by Prostate Specific Antigen (PSA)~     response, of both single agent ipilimumab and the combination of GM-CSF and ipilimumab in~     chemotherapy-naïve patients with metastatic castrate resistant prostate cancer.~   "
155488|NCT01530971|"~     Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean~     section under spinal anesthesia. However, evidences supporting the practice is not clear~     nowadays, especially for healthy parturients who are monitored continuously with pulse~     oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and~     newborns.~      Changing practice is not that easy. This study has been conducted to prove that supplemental~     oxygen is not necessary for healthy parturients during cesarean section.~   "
155489|NCT01530958|"~     The purpose of this study is to evaluate the feasibility and acceptability of two different~     interventions aimed at improving health outcomes among patients with chronic kidney disease~     (CKD), who are at high risk of CKD progression. Specifically, this study will examine how~     best to implement a provider-level intervention (access to a CKD-registry) and a~     patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on~     patient health outcomes, with a 2x2 factorial design.~   "
155490|NCT01530945|"~     Patients with end-stage kidney disease (ESKD) must manage not only the demands of dialysis~     and comorbid conditions but also associated symptoms and acute life-threatening events that~     contribute to functional limitations and increased risk of mortality. Yet little is known~     about the trajectories of quality of life dimensions in patients with ESKD when they~     experience acute life-threatening episodes, to guide palliative care for this population. In~     this prospective, descriptive study, we will identify trajectories of symptoms, physical~     functioning, psychosocial needs, and emotional and spiritual well-being in 200 patients with~     ESKD who are at a high risk of experiencing acute life-threatening events and mortality~     within 12 months.~   "
155491|NCT01530932|"~     Sepsis remains a common entity in critical care patients with remarkable mortality. Pulmonary~     and abdominal infections (with subsequent sepsis) are the most common in the ICU. Despite~     extended research activities, no differences in patient outcome or organ dysfunction were~     revealed.~      Sepsis is a complex immune reaction phenomenon based on unbalanced activation and~     suppression. In addition to changes of cytokine levels and immune cell activity, underlying~     genetic reactions are present. For instance, expression of miRNA (as a potential important~     step of immune cell activation) is likely changed during systemic and local immune reactions.~      The aim of this study is to perform a detailed assay of immune cell activation, to~     investigate the levels of pro- and antiinflammatory cytokines and the various expression of~     miRNA depending on the origin of infection in the two most common sides. This means in ICU~     patients with early pulmonary or abdominal sepsis as well as in healthy controls.~     Additionally, clinical parameters of organ function, current infection markers as CRP and~     procalcitonin, cardiovascular function and heart rate variability will be assessed.~     Parameters of local tissue perfusion in a dynamic testing during forearm ischemia and plasma~     adenosine concentration will be measured.~   "
155492|NCT01530919|"~     The main purpose of this research study is to evaluate the effectiveness of a minimally~     invasive surgical approach to removing parathyroid gland(s). The researchers are also~     interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that~     may contribute to overactive parathyroid gland(s).~   "
155493|NCT01530906|"~     Bulimia nervosa is defined by recurrent episodes of binge eating followed by compensatory~     behaviors (such as induced vomiting) to prevent weight gain. It is a common and serious~     disease for which current treatment strategies have to be improved.~      The aim of this study is to assess whether a transcranial magnetic stimulation reduces~     bulimic symptoms in a short term.~   "
155494|NCT01530893|"~     The primary aim of this placebo-controlled study is to determine whether flavonoids~     beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated~     cardiovascular risk.~      The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and we~     will assess the effects of the food matrix, and aspects of isoflavone metabolism.~   "
155495|NCT01530880|"~     Fever, defined as temperature higher than 38.3C (100.9 F), is common in patients with head~     injuries and is associated with poor recovery after injury. The current standard of care is~     to use oral acetaminophen (Tylenol) followed by a body cooling device. This method can~     effectively reduce fever but results in a high rate of shivering. Shivering is stressful to~     the heart and can further worsen brain injury. Methods to combat shivering have been~     developed and are successful in limiting the stress in the majority of patients that use a~     body cooling device. However, the drugs used to control shivering are sedating and may also~     interfere with brain recovery.~      The purpose of this study is to assess whether ibuprofen given intravenously is more~     effective in combating fever than the current standard of care. Should results from this~     study demonstrate that ibuprofen infusion is effective, a larger study will be conducted to~     determine whether this aggressive fever control regimen leads to improved recovery after~     brain injury.~   "
155619|NCT01529255|"~     -  The purpose of this study is to to prove that the long-term efficacy of strategy of~          treatment adjustment at W24 according to virological response based on ROADMAP concept~          is better than standard of care strategy.~        -  To evaluate the off-treatment durability of HBeAg seroconversion in patients who~          discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml~          with over 12 months consolidation treatment~   "
155496|NCT01530867|"~     Over half of all Americans take dietary supplements (vitamins, minerals, herbal products)~     along with their prescription medications. With the economic downturn, dietary supplement~     sales have surged, perhaps as a result of people attempting to stave off or delay medical~     care. Supplements are generally thought to be harmless, but some can potentially interact~     with prescription medications, cause liver or kidney damage, and even adversely affect~     surgical outcomes. Those substituting dietary supplements for prescription medications also~     may suffer significant adverse consequences. The United States Food and Drug Administration~     and the Institute of Medicine recommend that patients considering dietary supplement use~     consult their providers. Unfortunately, patients fail to disclose dietary supplement use in~     up to two-thirds of outpatient office visits. To improve discussions, it is important to~     understand what prompts physicians and patients to communicate about dietary supplements.~      The overall objectives of this application are to understand how, when and why physicians and~     patients communicate about dietary supplements, and to assess how patients respond to these~     discussions. An ethnically diverse group of patients and their physicians will be surveyed~     and their office visits will be audio recorded. Audio recordings of the visits will be used~     to assess the relationship of patient and physician attitudes and values, and the~     physician-patient relationship on dietary supplement discussions. A subset of these patients~     and physicians will be interviewed to explore how they made decisions to initiate or forgo~     discussions about supplements. They also will be asked questions concerning the necessity of~     and responsibility for initiating dietary supplement conversations. Patient responses and~     reactions to actual discussions also will be explored. Data from observed and reported~     interactions will be compared to provide a deeper understanding of factors related to~     disclosure. This project aims to provide a broad understanding of the content of~     physician-patient discussions about dietary supplements, and to describe how and why~     physician and patient attitudes and opinions affect these discussions. Identification of~     mutable factors can result in interventions to increase communication about dietary~     supplements, help maintain patient safety, and promote appropriate use of supplements~     concurrent with prescription medications.~   "
155497|NCT01530854|"~     Plasma free fatty acids (FFAs) are thought to play a role in the generation of organ~     dysfunction. The investigators hypothesize that plasma FFA levels are a marker of poor~     prognosis in patients with sepsis. The present study will examine the relation between plasma~     FFA levels and severity of illness in patients with sepsis presenting to the Emergency~     Department. It will also examine the relation between plasma FFA levels and the risk of~     developing late morbidity, multiple organ dysfunction syndrome (MODS) and/or mortality during~     initial hospitalization and over a 30-day follow-up period.~   "
155498|NCT01530841|"~     Myotonic dystrophy type 1 is a myopathy with complex respiratory pattern and at risk to~     develop respiratory failure. Classical mode of ventilation are sometimes not tolerated or~     ineffective in this population. New modes of nocturnal ventilation by combining both~     volumetric and barometric advantages. The aim of this study is to compare effect of AVAPS~     mode to bilevel pressure support.~   "
155499|NCT01530828|"~     This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal~     perforation in infants who are at high risk. Analysis of perforation rates of all infants in~     the three largest participating sites shows that the majority of infants with perforation~     will do so prior to day of life 21. This study will target the group of infants at highest~     risk for IP, those with birth weight less than 1000 grams, within the time frame most likely~     to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate~     premature infants with and without intestinal perforation in the first 3 weeks of life.~   "
155500|NCT01530815|"~     The investigators are testing to see if infusion of bupivicaine between the mesh and~     abdominal wall can reduce postoperative pain and decrease use of narcotics in the~     postoperative setting.~   "
155501|NCT01530802|"~     The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with~     vascular clips can reduce blood loss significantly.~   "
155502|NCT01530789|"~     Feasibility monocentrique opened study estimating the use of an electronic personalized~     educational plan (ePEP) for the follow-up by nurses of 50 patients diabetics type 1 during 6~     months having an electronic pad.~   "
155503|NCT01530776|"~     The purpose of this study is to assess the feasibility and efficacy of an~     electronically-mediated, pregnancy and postpartum, behavioral intervention program, compared~     to usual obstetric care, on changes in weight and cardiometabolic biomarkers among overweight~     and obese Black women.~   "
155504|NCT01530763|"~     This is a study of safety and effectiveness of ceftaroline fosamil in children with Community~     Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.~   "
155505|NCT01530750|"~     Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up~     to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks~     before the surgery. Frequency, burden, and possible risk factors will be described.~      During the operation direct contact epicardial mapping will be performed and tissue samples~     will be collected to identify an electrophysiological and a structural substrate for~     development of AF.~   "
155506|NCT01530737|"~     The primary objective of this study is:~      1. To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age~     undergoing cardiopulmonary bypass (CPB) for cardiac surgery~      The secondary objectives of this study are:~        1. To determine if the administration of AT concentrate prior to heparinization will~          decrease the amount of heparin required to achieve optimal anticoagulation (as defined~          by anti-Xa levels) during CPB~        2. To determine if a decrease in activation and consumption of coagulation proteins,~          platelets and subsequent fibrinolysis will result in improved haemostasis following CPB~        3. To determine if there will be a reduction in postoperative bleeding and associated~          clinical complications~   "
155507|NCT01530724|"~     The investigators hypothesize that differential dynamics in fat depots in response to two~     opposing dietary strategies mediate the beneficial metabolic effects during weight loss and~     regain phases.~   "
155508|NCT01530711|"~     Observe the effect of terlipressin on renal function in patients with SHR type I adjusting~     the dose based on hemodynamic response.~   "
155509|NCT01530698|"~     Objectives: This is an exploratory study, consisting of two parts. In part I dose escalation~     is performed and the primary objective is the safety of different doses of TLR-DC and Trimix~     DC. In part II Trimix DC vaccination will be compared with TLR-DC vaccination and the primary~     objective of this part is the immunological response, with toxicity and clinical efficacy~     being secondary objectives. These studies will provide important data on the safety and~     immunological effects of TLR-DC and Trimix DC.~      Study design: Part I of this study is an open label dose escalation study. Part II of this~     study is an open label randomized phase II study.~      Study population: Our study population consists of melanoma patients, with proven expression~     of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional~     lymph node metastasis in whom a radical lymph node dissection is performed within 2 months of~     inclusion in this study (further referred to as stage III) and melanoma patients with~     measurable distant metastases (further referred to as stage IV) will be included.~   "
155510|NCT01530685|"~     The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary~     supplement, on glycemic control of overweight prediabetic subjects.~   "
155511|NCT01530672|"~     This is a diagnostic validation study for a combined Syphilis/HIV test made by MBio~     Diagnostics, Inc (MBio, Boulder, CO, USA). Although the MBio Syphilis/HIV diagnostic platform~     is designed for use at point of care (POC), it is made to provide similar performance as~     reference standards. Diagnosing HIV and syphilis accurately with a single POC test will save~     time for clinic health workers and technicians, reduce loss-to follow-up caused by lengthy~     delays for lab-based tests, and save costs by eliminating the need for multiple tests. For~     this study, the sensitivity and specificity of the MBio HIV/Syphilis Serology System~     point-of-care diagnostic test will be determined using reference tests performed under~     controlled laboratory conditions. For this, clients receiving routine care in the ANCs at the~     New Nyanza Provincial General Hospital (NNPGH) and Kisumu District Hospital (KDH) will be~     consented to provide blood for the proposed study. Study volunteers will receive HIV and~     syphilis rapid tests provided as part of routine care, and will donate an additional blood~     for evaluating the MBio test against the reference tests in a laboratory setting. This study~     is an investigational prototype, not for product registration. The results from this study~     will be used to inform product development of a second iteration of the MBio device design.~     At the time that the device is ready to be registered, it will undergo another field~     evaluation at which time it will be submitted to the appropriate regulatory body. Because the~     MBIO device is an HIV test, the device would be submitted to National AIDS & STI Control~     Program (NASCOP), which is the appropriate regulatory body for HIV tests in Kenya.~   "
155512|NCT01530659|"~     This clinical trial is a single-site, 30 patient study for participants who have early stage~     retinitis pigmentosa, or Usher syndrome (type 2 or 3). Funding Source - FDA OOPD and~     Foundation Fighting Blindness.~   "
155513|NCT01530646|"~     It is known that dieting (restricted energy intake) without resistance training leads to a~     reduced metabolic rate, and the loss of both fat and muscle mass. When exercise is not~     included in a period of restricted energy intake, the degree to which muscle mass is lost is~     highly dependent upon protein consumption. Whey protein is a high quality protein isolated~     from milk and is known to stimulate new protein synthesis for all proteins in your body.~     Previous research has established that the consumption of whey protein has been correlated~     with retaining muscle mass while stimulating fat loss. However, the mechanisms behind these~     findings is still unknown. The purpose of this study is to establish a mechanistic~     underpinning to the efficacy of whey protein versus soy protein and a carbohydrate control~     (maltodextrin), in promoting fat mass loss and lean mass retention during a period of~     short-term controlled dietary energy deficit (-750 kcalories/day).~   "
155514|NCT01530620|"~     The purpose of this clinical study is to compare efficacy and safety of propiverine~     hydrochloride extended and immediate release formulations in patients suffering from~     neurogenic detrusor overactivity.~   "
155515|NCT01530607|"~     This is a phase III trial of LHRH analog administration during chemotherapy to reduce ovarian~     failure following chemotherapy in early stage, hormone-receptor negative breast cancer.~   "
155516|NCT01530594|"~     This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose~     dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose~     dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma~     without an intent for immediate autologous stem cell transplant.~   "
155517|NCT01530581|"~     This is a Randomized Multicentre study Comparing GCSF Mobilized Peripheral Blood and GCSF~     stimulated Bone Marrow in Patients undergoing matched sibling Transplantation for~     Haematologic Malignancies.~   "
155518|NCT01530568|"~     Aim:~      To evaluate the diagnostic utility and impact on patient outcomes of an automated PCR (Gene~     Xpert® MTB/RIF), in a group of patients with suspected pulmonary TB who are mechanically~     ventilated in ICU, using tracheal aspirates.~      Hypothesis:~      Gene Xpert is an accurate tool for the diagnosis of TB in the Intensive Care Unit and will~     impact on rates of treatment initiation and hospital stay.~   "
155519|NCT01530555|"~     To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG,~     Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with acquired~     severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who~     are transfusion dependent. To compare the response rate of the combination of rabbit ATG~     (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of~     matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®)~     and CSA; obtained from the EBMT database (comparative study).~   "
155520|NCT01530542|"~     This is an open-label (both the physician and healthy volunteer know which medication will be~     administered), single-dose, 5-dosing period study to characterize the pharmacokinetics~     (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the~     body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place~     over approximately two and a half months and will consist of three phases: a screening visit~     to determine eligibility for the study, a 5-dosing period treatment phase, and an~     end-of-study visit.~   "
155521|NCT01530529|"~     The purpose of this study is to assess the bioavailability, safety, and tolerability of a~     modified-release formulation of PF-05180999 relative to an immediate-release formulation in~     healthy adult subjects. Two doses of the modified-release formulation and one dose of the~     immediate-release formulation will be evaluated under fasted conditions. One dose of the~     modified-release formulation will also be evaluated in the presence of food.~   "
155559|NCT01530035|"~     A one-year intervention study of 41 healthy elderly men aged 65-75-years.Of these, 24~     subjects are untrained men with no regular training activity for the last 5 years. After~     medical screening and pre-testing, they will be randomized into a football group (n=9), a~     strength-training group (n=9) or a sedentary control group (n=6). Additional 17 subjects are~     recruited from local football clubs and have been active football players for the last 40~     years. Training will be performed 3x1 hour per week and evaluation will take place after 0, 3~     and 12 months. Primary endpoints will be changes in cardiac and vascular structure and~     function measured by advanced echocardiography (tissue Doppler and speckle tracking imaging),~     and peripheral arterial tonometry (Endo--‐PAT device). Secondary endpoints will be evaluation~     of potential changes in VO2 max, blood pressure, muscle capillaries, lipid profile,~     circulating catecholamines, body composition, and insulin resistance.~   "
172215|NCT01311011|"~     Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with~     Critical Limb Ischemia~   "
155522|NCT01530516|"~     Class II malocclusion (mismatch between the upper and lower jaw in which the lower jaw~     appears to be smaller from a profile point of view) are common in the general population.~     Around 1/3 of the population have some degree of this skeletal/dental problem and it is one~     frequent reason why patients decide to undergo orthodontic treatment. Treatment alternatives~     will basically depend on the facial skeletal development of the patient and also on the~     magnitude of the skeletal/dental discrepancy.~      For patients that are not yet fully skeletal mature, the treatment of mild to moderate Class~     II malocclusion involves a combination of a small skeletal growth modification effect and~     more significant dental movements. For skeletal mature individuals with a severe mismatch,~     the treatment usually involves jaw surgery to fully correct the malocclusion. For less severe~     cases orthodontic camouflage exclusively done by orthodontic movements is an option.~      If the case is not severe enough to warrant a surgical approach there are several treatment~     alternatives. One of the most commonly used options is the use of orthodontic loaded springs~     that apply forces through brackets and arch wires bonded into the teeth so that the teeth~     will interrelate better.~      A different alternative was proposed some years ago. The Xbow (spelled Crossbow) appliance~     differs from the above-proposed option in that no brackets are bonded or arch wires used. The~     orthodontic springs are applied to a metal framework cemented on some upper and lower teeth.~     Once the skeletal/dental problem is believed to have been significantly improved, fine tuning~     of the remaining dental problems is managed with brackets and arch wires. The theoretical~     advantage of such a design is that adverse effects, such as root resorption and~     decalcification from the long-term use of brackets and arch wires, are theoretically~     minimized as the brackets and arch wires have to be used for a shorter period of time.~      Although there are some retrospective reports about the skeletal and dental effects of the~     Xbow appliance and only one prospective trial comparing the skeletal and dental changes to a~     non-treated growing sample; no randomized clinical trial has yet evaluated the changes~     compared to a current standard of care alternative which is the simultaneous use of loaded~     springs concurrent with brackets and arch wires.~   "
155523|NCT01530503|"~     The purpose of this study is to assess the therapeutic activity of capecitabine alone or in~     combination with mitomycin C as second-line therapy in patients with advanced/metastatic~     biliary adenocarcinoma in progression after gemcitabine and platinum compounds~   "
155524|NCT01530490|"~     The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF)~     cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of~     cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.~   "
155525|NCT01530477|"~     This study is being conducted to examine the performance of three common DXA machines (1)~     Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body~     fat.~   "
155526|NCT01530464|"~     This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with~     the primary objective of testing the safety and tolerability of combined oral doses of~     aminophylline and ambrisentan in healthy human subjects. The secondary objective is to assess~     the pharmacokinetic profiles of theophylline (aminophylline) and ambrisentan when~     administered alone or in combination. It is hypothesized that the combination of these drugs~     is generally safe, and that no drug interaction can be observed.~   "
155527|NCT01530451|"~     The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia~     in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the~     quality of life will be measured.~   "
155528|NCT01530438|"~     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that involves not only~     motor structures, as was previously thought, but also brain areas dealing with cognition as~     well as parts of the limbic system. Clinical, imaging and pathological evidence suggests that~     ALS and fronto-temporal dementia (FTD) have several features in common, and that these two~     diseases could be the two ends of a pathological continuum.~   "
155529|NCT01530425|"~     Two wheelchair types available for children in Kenya are compared for energy costs, utility,~     and complications. This study will arrive at a protocol for comparing wheelchairs in~     low-income settings, and in the process, provide wheelchair makers and providers with~     specific feedback. It also serves as a means to increase the skills of local health~     professionals working with the children in this study, while providing them with appropriate~     wheelchairs to use.~   "
155530|NCT01530412|"~     Sustained improvement after pulmonary rehabilitation in activity levels as measured by an~     activity armband.~      Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and~     prognosis for patients who suffer from chronic obstructive pulmonary disease. There is also~     strong evidence that supports the use of pulmonary rehabilitation to decrease hospital~     admissions thereby reducing cost of care. Recent studies suggest that the significant~     benefits achieved through rehabilitation fade with time and that in order to improve~     activities of daily living; for example, average daily number of steps, programmes of longer~     duration are required.~      The primary aim of this study is to identify objective sustained improved in activity levels~     using the SenseWear activity armband after a short-term pulmonary rehabilitation programme.~     Secondary aims are to determine antibiotic and steroid use pre and post rehabilitation.~   "
155531|NCT01530399|"~     The objective of this study is to determine the dose response relationship regarding blood~     loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid~     in patients undergoing primary cardiac surgery with cardiopulmonary bypass. The aim of the~     study is to define minimally effective dose of MDCO-2010.~   "
155532|NCT01530386|"~     The effects of Lacosamide, an antiepileptic drug, on sleep have not been formally evaluated.~     The present study is being conducted to assess the effects of Lacosamide on sleep quality in~     healthy subjects.~   "
155533|NCT01530373|"~     Hot flashes present a considerable problem for many breast cancer patients; these symptoms~     may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This~     study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in~     reducing hot flashes, compared with clonidine (a medication often used for treating hot~     flashes).~   "
155534|NCT01530360|"~     Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The~     investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of~     hyper- and hypoxia can be accomplished during the first three days of life in infants born~     before 28 completed weeks of gestation. The investigators developed a treatment guideline and~     a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be~     reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10~     infants.~   "
155560|NCT01530022|"~     The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological~     effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after~     administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also~     be collected.~   "
155620|NCT01529242|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the treatment of acute cutaneous rash in children between 2~     and 12 years old.~   "
155535|NCT01530347|"~     Segment 1- this segment will include two main steps:~      Step 1-Calibration: During this step we plan to collect paired measurements of capillary~     blood glucose using reference method and data generated by the non invasive study device.~     Samples will be obtained at specific time points during 4 hours: at fasting, and after~     consuming standard liquid meal at 60, 120, 180 and 240 minutes. At each time point capillary~     blood glucose will be measured using the invasive reference method. The paired reference and~     study device data will be analyzed using multivariate regression model to formulate a~     calibration algorithm model. This model will convert the acetone values measured by study~     device to blood glucose values.~      step 2-Validation: During this segment the second step of this segment we plan to evaluate~     the validity and reliability of the non-invasive breath-based glucometer compared to standard~     invasive reference glucometer. Results will be compared using a Clark error grid.~      Segment 2- During this segment we plan to collect paired measurements of capillary blood~     glucose beta Hydroxybutyrate using reference method and acetone values generated by the non~     invasive breath based study device. Samples will be obtained at specific time points during 4~     hours after overnight fasting, while basal insulin will be suspended, which is accepted to~     produce ketosis.~   "
155536|NCT01530334|"~     the primary objective is to characterise the impact of gefitinib on the Response Evaluation~     Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ;~     confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR;~     confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients~     with EGFR M+ NSCLC~   "
155537|NCT01530321|"~     This study will determine the number of visits to a chiropractor for spinal manipulation and~     light massage necessary for the optimal relief of cervicogenic headache (headache with~     associated neck pain). Effectiveness of care will also be determined.~   "
155538|NCT01530308|"~     The investigators propose a multicenter, randomized, double-blinded, placebo-controlled trial~     to study the effect of additive low-dose haloperidol prophylaxis on top of exciting care in a~     general population of older patients (age 70 years and over) acutely admitted to the hospital~     through the emergency department (ED) for general medicine and surgical specialties, and who~     are at-risk for developing in-hospital delirium on admission according to the VMS delirium~     risk questions (one or more positive answers out of three questions).~      The investigators hypothesize that this intervention will reduce the incidence of in-hospital~     delirium as well as duration and severity of delirium.~   "
155539|NCT01530295|"~     Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in~     Patients with High Risk Prostate Cancer.~      The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and~     prednisone are effective in the treatment of high risk localized prostate cancer.~   "
155540|NCT01530282|"~     The study aims to assess the agreement between respiratory mechanics parameters measured~     noninvasively by means of brief airways occlusions at the beginning of inspiration and the~     reference parameters obtained with standard techniques of esophageal and gastric pressure~     under static and dynamic conditions in a mixed population of ICU patients mechanically~     ventilated in pressure support ventilation mode.~   "
155541|NCT01530269|"~     Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant~     metastases from prostate cancer. This clinical trial is studying how this imaging test may~     help influence the choice and extent of initial treatments, and subsequent treatments.~   "
155542|NCT01530256|"~     The purpose of this study is to determine the safe and tolerable, biologically active, and~     potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to~     respond to glucocorticosteroids, for further investigation in Part B.~   "
155543|NCT01530243|"~     The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin~     and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.~   "
155544|NCT01530230|"~     The investigators examined whether there was a difference in the occurrence of ST depressions~     after injection of five or ten units of oxytocin, in preeclamptic patients delivered by~     caesarean section (CS) under regional anesthesia.~   "
155545|NCT01530217|"~     Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study~     is to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office~     bleaching.~      Methods: 30 health adults who received either placebo or ibuprofen. The drugs were~     administered 1 hour prior to the bleaching and will be prescribed 5 doses every 8 hours~     during 48 hours. For bleaching will be used 35% hydrogen peroxide gel. The tooth sensitivity~     will be recorded for up and lower arc on two scales: VAS (visual analogic scale) and 0-4. The~     shade evaluation will be performed before and 30 days after bleaching with visual shade guide~     and spectrophotometer.~   "
155546|NCT01530204|"~     The primary question addressed by this prevention study is to explore if improving pain and~     disability reduces episodes of Major Depression among seniors with knee osteoarthritis (OA)~     and mild depressive symptoms.~   "
155547|NCT01530191|"~     The specific aim of this study is to determine if pre-existing depression and anxiety affect~     perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse.~        -  Hypothesis 1: Patients with depression will have increased analgesic use and longer~          hospital stays postoperatively~        -  Hypothesis 2: Patients with anxiety will have increased analgesic use and longer~          hospital stays postoperatively.~      A secondary aim is to characterize the incidence and severity of depression and anxiety in~     patients scheduled to undergo surgery for pelvic organ prolapse.~   "
155573|NCT01529853|"~     Primary Objective:~      To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and~     tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly~     over a 6-week period.~      Secondary Objectives:~      To assess in adult patients with IPF:~        -  The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests~          (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers.~        -  The trough plasma concentrations of SAR156597~        -  The potential immunogenicity of SAR156597.~   "
155574|NCT01529840|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the effect of~     somatropin (Norditropin®) on final height in children with Noonan syndrome having being~     treated for up to 10 years with somatropin (Norditropin®) for the attainment of an optimal~     final height in the original trial S/GHD/004/NOO.~   "
155548|NCT01530178|"~     There are many recent advances in insulin treatment of type 1 diabetes, however after a meal~     sugars are always a concern. There is a drug sitagliptin (Januvia) which is FDA approved to~     treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals.~     This study is going to test whether this drug can improve the after meal sugars in people~     with type 1 diabetes. To test this you will be given a test mixed meal and its effects on~     insulin, other hormones that affect blood glucose as well as your sugar will be measured by a~     series of blood tests. Insulin dose will be reduced by 20-50% to prevent low blood sugars~     which might occur because of food staying longer in the stomach than usual or due to the~     suppression of a hormone called glucagon which increases blood sugar. If you qualify you will~     be given sitagliptin (Januvia) 3 different times in 25 mg, 50 mg and 100mg dosages. You and~     the researchers will not know which dose you are taking at any single visit. A total of 30~     people in which some will be children aged 13- 17 and others will be adults aged 18-30 will~     participate. Some will have had diabetes for over a year, others will be within 3 months of~     having been found to have type 1 diabetes. Furthermore, only 18-30 year people who are~     diagnosed with type 1 diabetes for a year or more will be studied initially (4 subjects) to~     establish safety data before younger subjects are enrolled into the study.~   "
155549|NCT01530165|"~     The Karachi-based Pakistan Diabetes Prevention Study aims to address key issues in the~     prevention of type 2 diabetes. Approximately 20,000 people From four communities will be~     screened for diabetes risk factors using a non-invasive diabetes risk-score system. Those~     found to be at increased risk will be given an oral glucose tolerance test. People who, after~     the oral glucose tolerance test, are identified as having prediabetes will have the~     opportunity to take part in the Pakistan Diabetes Prevention Study lifestyle intervention.~     This consists of culturally adjusted preventive strategies focusing on diet and physical~     activity in real-life settings. Another important aspect of this trial will be to assess the~     impact of urban planning on the prevalence of obesity and diabetes.~   "
155550|NCT01530152|"~     Aim:~      The aim of the method evaluation study is a comparing study of Truview PCD™ (Picture Capture~     Device) laryngoscope vs. Macintosh laryngoscope. The result of this study will form a basis~     for a possible recommendation of the Truview PCD™ laryngoscope in our organisation.~      The laryngoscopes are compared according to their ability to visualize the glottis area~     measured by the Cormack Lehane (CL) grade and the time used to get the best CL grade.~      A registration of any damage of tissue/teeths caused by the laryngoscopes, and a possible~     decrease of the saturation will also be made.~      Hypothesis:~      The Truview PCD™ laryngoscope provides a better view of the vocal cords and thereby makes the~     intubation les difficult.~      CL 1 is achieved in 90 percent of intubations with the Macintosh laryngoscope, and the~     hypothesis of the study is that CL 1 can be increased to 98 percent by use of the Truview~     PCD™ laryngoscope.~   "
155551|NCT01530139|"~     The concept of personalised nutrition emerged following the sequencing of the human genome in~     2000. It was hoped that with the identification of gene nutrient interactions, an~     individual's response and susceptibility to particular diets would be better understood and~     therefore appropriate dietary modifications could be made to optimise health and lower~     disease risk. Then Food4Me aims to study the development of personalized nutrition at three~     levels and determine whether providing more personalised dietary advice leads to better~     compliance and health outcomes compared to standard population advice.~      The hypotheses to be tested in the Food4Me study are as follows:~        -  Personalisation of dietary advice assists and/or motivates consumers to eat a healthier~          diet and follow a healthier lifestyle (in comparison with impersonal [conventional]~          dietary advice).~        -  Personalisation based on individualised biochemical (phenotypic) and/or genetic~          information is more effective in assisting and/or motivating study participants to make,~          and to sustain, appropriate healthy changes to their usual (habitual) diet and~          lifestyle.~   "
155552|NCT01530126|"~     The aim of the study was to evaluate the safety and effectiveness of Platelet Derived Growth~     Factor (PDGF) mixed with b tricalcium phosphate (BTCP) for the treatment of advanced~     periodontal osseous defects at 6 months of healing.~   "
155553|NCT01530113|"~     The study aims to develop a theoretical model explicating the inter-relationships between~     Childhood Sexual Abuse (CSA), Partial Vaginismus (PV) and Labor Dystocia (LD), including~     their associations with Depression (D) as a mediating variable.~      The following research hypotheses will be tested:~        1. CSA will serve as a risk factor for D, PV and LD.~             -  pregnant women with a history of CSA will have higher levels of D compared to~               pregnant women without a history of CSA.~             -  pregnant women with a history of CSA will have more PV compared to pregnant women~               without a history of CSA.~             -  pregnant women with a history of CSA will have higher levels of LD compared to~               pregnant women without a history of CSA.~        2. D will serve as a mediator between prenatal PV and LD.~        3. PV will serve as a risk factor for LD.~        4. postpartum PV will be affected by childbirth (LD vs. no LD) contingent on the level of~          D.~   "
155554|NCT01530100|"~     This study will examine the use of lower laser therapy to reduce edema and pain in~     orthognathics surgery.~   "
155555|NCT01530087|"~     The purpose of this study is to provide preliminary assessment of the safety and performance~     of a novel barrier formulation (CASTLE) in a small population of subjects with irritated~     peristomal skin.~   "
155556|NCT01530074|"~     The purpose of this study is to determine the contribution of the innervation of the~     contra-lateral mandibular nerve for the innervation of the lower lip area.~      The investigators hypothesis is that the sensation of the lower lip is contributed by both~     mandibular nerves (from both sides of the jaw).~   "
155557|NCT01530061|"~     This study will determine which breakfast (egg breakfast or bagel breakfast) has the most~     beneficial effect on appetite.~   "
155558|NCT01530048|"~     This trial is conducted in Europe. The aim of this trial is to test if there is~     bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin~     aspart 200 U/mL (U200) formulation.~   "
155586|NCT01529684|"~     The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of~     excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled~     OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the~     Optional Treatment Phase.~   "
155561|NCT01530009|"~     The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable~     effect on upper gastrointestinal motility compared to placebo. In particular, induction of~     phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary~     outcome of the study. MMCs are periodic waves of electrical activity resulting in muscular~     contractions that pass through the walls of the stomach and intestinal tract during the~     fasting state. It is characterized by an initial period where there is a minimal electrical~     activity and muscular contraction (phase I), followed by a gradual increase in the frequency~     of contractions (phase III) that often leads to a characteristic cluster of contractions~     (phase III). This cycle occurs only in the fasting state in normal individuals and the~     frequency of phase III is quite varied, dependent on age and the presence of any underlying~     abnormalities in gastrointestinal motility. Secondary outcomes will include characteristics~     of the MMC, patient demographics in responders and non-responders, and the safety profile of~     AMX at the intervention dose.~   "
155562|NCT01529996|"~     The primary objective of this study is to compare the efficacy of PDL and the 1064-nm Nd:YAG~     laser in the treatment of facial redness.~   "
155563|NCT01529983|"~     The primary objective of this study is to compare the efficacy of intense focused ultrasound~     and carbon dioxide-fractionated laser for treatment of periorbital wrinkles.~   "
155564|NCT01529970|"~     Parkinson's disease (PD) is the second most frequent neurodegenerative disorder after~     Alzheimer's disease. It causes motor dysfunctions, such as bradykinesia, resting tremor,~     rigidity and postural instability. Although PD appears to be sporadic in most cases, several~     causative genes and susceptibility factors have been identified that cause familial forms of~     the disease with Mendelian inheritance with autosomal dominant or autosomal recessive~     inheritance.~      Approximately 5~10% of patients with the clinical picture of PD carry a mutation in one of~     the known genes that cause monogenic forms of the disorder. The average age at onset is~     between 60 and 80 years and the average age of diagnosis is 60 years. Onset of primary~     parkinsonism before 50 years is known as early onset parkinsonism(EOP). Onset between 20 and~     50 years is known as young-onset PD. Onset at younger than 20 years is known as juvenile~     parkinsonism (JP). At least, 13 loci and 9 genes are reported. The investigators study is~     aimed to screen the clinical diagnosed familial EOP for the common mutation site by PCR/DNA~     sequencing. The gene for screen are Parkin (pattern: PARK2), PINK1 (pattern: PARK6) and~     ATP13A2 (pattern: PARK9).~   "
155565|NCT01529957|"~     The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in~     healthy Chinese volunteers.~   "
155566|NCT01529944|"~     This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation~     status and investigate the impact of the PTPN11 mutation status on the effect of somatropin~     (Norditropin®) by use of data obtained in the GHNOO-1658 trial.~   "
155567|NCT01529931|"~     The current study is a follow up study designed to gather information about the effect of the~     number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic~     Hair2Go treatment. This study includes taking photos and documenting endpoints but does not~     include treatments.~   "
155568|NCT01529918|"~     This pilot RCT study aims to develop and evaluate the uptake, feasibility, and potential~     value of a strategy for web-diabetes risk assessment versus paper-based methods in an~     undiagnosed diabetes population over 40 years of age from all listed FHT provided through an~     electronic medical record database. Following randomization, intervention participants will~     have the option to decide to use web-based self-screening and the control group will receive~     only a paper-based method. There will be two options for web-based screening; one involves~     completion of the CAN-RISK screening tool as part of a personal health record self-management~     program (MyOscar) versus a one off online risk-assessment. The intervention and control group~     will be compared with respect to risk-assessment uptake. Educational sessions and further~     assessment of diabetes conducted by the clinical health care team will be offered to all~     participants who scored a high risk of diabetes in accordance with the CAN-RISK results.~     Actual numbers of diabetes cases in those with a high risk score will be compared between the~     intervention and control groups as well as compared to the usual method of diabetes screening~     in a randomly chosen non-identifiable sample from the same clinical setting in the same one~     year period. The assessment of patient acceptability in feasibility of the implementation of~     the self-screening tool will be accomplished through surveys designed to be completed by~     patients and staff.~   "
155569|NCT01529905|"~     The goal of this project is to study the course and outcome of illness in individuals who~     present with a first episode of depression or mania, or who have a recurrent disorder but~     have never received treatment. We plan to examine psychological, physical, social and~     environmental factors that may affect long-term outcome in these disorders~   "
155570|NCT01529892|"~     Methamphetamine abuse and addiction are widespread and is causing increasing pressures on~     social, public health and criminal justice systems worldwide. Some of the risk for developing~     addiction may be genetic. Identifying specific genotypes and understanding their interactions~     with the environment may help predict who is at risk for developing a disease. In this study~     the investigators are evaluating the contribution of differences in one genotype - called~     CYP2D6 to the removal of methamphetamine from the body. Methamphetamine is removed from the~     body by special enzymes in the liver. One of these enzymes is called Cytochrome P450 2D6. The~     activity of 2D6 is genetically determined. Some people have no active 2D6 whereas in others~     2D6 is very active. One group of scientists found that people with low 2D6 activity were less~     likely to become methamphetamine addicts. In this study the investigators will determine the~     activity of your 2D6 by looking at the CYP2D6 genotype. If low levels of 2D6 decrease the~     risk of methamphetamine addiction it may be because there is less of the chemicals (called~     metabolites) made by 2D6. The first step in the metabolism (the process of removal of drugs~     from the body) of methamphetamine by 2D6 is conversion of methamphetamine to amphetamine and~     para-hydroxymethamphetamine. 2D6 then converts these to inactive chemicals. In addition to~     determining your genotype, the investigators are interested in the relationship of genotype~     with the methamphetamine metabolism. Thus, as part of this study, you will be given a modest~     oral dose of 5 milligrams of methamphetamine. After receiving the methamphetamine you will~     need to collect your urine for 24 hours.~      The purpose of this study is to investigate the impact of genetic variation in CYP2D6 on the~     disposition of methamphetamine in the human body as well as its pharmacologic effects to~     humans.~   "
155571|NCT01529879|"~     Integration success rates and the preservation of crestal bone will be higher for the~     experimental device than for the control implants.~   "
155572|NCT01529866|"~     Integration success rates measured by lack of implant mobility and crestal bone regression~     measurement will be higher for the experimental implant design than for the control implants.~   "
155587|NCT01529671|"~     The purpose of the study is primarily to determine the safety and toleration and~     pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days.~   "
155575|NCT01529827|"~     This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose~     total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT)~     works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as~     fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the~     growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting~     the donor's stem cells. When the healthy stem cells from the donor are infused into the~     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood~     cells, and platelets. Sometimes the transplanted cell from a donor can make an immune~     response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and~     methotrexate after transplant may stop this from happening~   "
155576|NCT01529814|"~     Integration success rates measured by resistance to countertorque testing will be higher for~     the experimental implant design than for the control implants.~   "
155577|NCT01529801|"~     A study where dental implants with different roughened surfaces will be evaluated for the~     ability to resist countertorque forces.~   "
155578|NCT01529788|"~     The objective of the study is to compare the time to onset of Dysport® versus Botox® in the~     treatment of lateral orbital rhytids (crow's feet). Thirty subjects were enrolled in the~     study; specifically 30 male or female patients 18 years or older with moderate to severe~     lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated~     with Dysport® on one side and Botox® on the other side. Both the injector and patient were~     blinded to the injected toxin.~      The efficacy endpoints were determined by investigator and subject live assessment of crow's~     feet at rest and maximum contraction at each visit (every other day for 6 days~     post-injection, every month for 9 months following) using a validated 5 point photographic~     scale(no wrinkles [0], very fine wrinkles [1], fine wrinkles [2], moderate wrinkles [3] or~     severe wrinkles [4]) used in previous studies. A written description of each photograph was~     included to help standardize the application of the Photographic Scale.~   "
155579|NCT01529775|"~     This study will demonstrate the benefits of platform switching design of the Osseotite dental~     implant.~   "
155580|NCT01529762|"~     Osseotite Certain Tapered implants placed in immediate prosthesis loaded cases.~   "
155581|NCT01529749|"~     This is a open controlled trial in which 48 HIV-1 patients successfully treated with~     EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The~     four arms are as follows:~      Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF +~     MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12)~      The allocation will take place in two phases:~      Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan~      If losartan arm shows benefits we will proceed to the second phase:~      Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan.~      Patients will be followed up during 12 months to determinate the proportion of patients with~     decreased collagen deposition in TL equal to or greater than 50%.~   "
155582|NCT01529736|"~     Osseotite implants placed with higher insertion torque (TEST procedure) will have higher~     initial stability and integration success than those placed with lower insertion torque~     forces.~   "
155583|NCT01529723|"~     Dysphagia or swallowing difficulty is common after stroke occurring in 25-78% of stroke~     survivors depending on the anatomic location of the stroke and the diagnostic test used.~     There are no universally accepted methods for doing a screen test at the bedside in the~     immediate setting after stroke. This study will assess the reliability of a bedside screen in~     terms of reproducibility of results between 2 independent screeners and in comparison to a~     fiberoptic study done by a speech language pathologist.~   "
155584|NCT01529710|"~     Clinical Trial Phase:Phase III~      Primary Objectives:~        -  Compare Mirazid and Praziquantel cure rates for both Schistosoma species.~        -  Compare Mirazid and Praziquantel effect in lowering the intensity of infection for both~          Schistosoma species.~      Secondary Objective:Identify and compare the types and severity of side and adverse effects~     between the Mirazid and Praziquantel.~      Study Population:200 Schistosomiasis infected persons of both types of Schistosomiasis aged~     from 15-35 years. Those subjects will be selected from among those screened.Subjects will~     include both genders excluding chronically ill such as chronic liver disease patients and~     those with both types of Schistosomiasis.~      Recruitment Period:3 months and subjects follow up for another 3 months followed by 3 months~     for statistical analysis and report writing Study Duration: Total study duration is expected~     to be 9 months: 3 months for recruitment, 3 months for follow up and 3 months for data~     management and report writing.~      Endpoints: Will be measured at 3 months of successful administration of treatment either~     Mirazid or Praziquantel as per the randomization scheme. By then, final assessment of the~     response to treatment will be done by examining urine or stool of the subject for presence of~     Schistosoma eggs and its density if found.~      Three negative urine or stool samples collected 2-days apart at 12 weeks post treatment will~     indicate treatment success. One positive sample collected at week 12 will indicate infection~     with Schistosomiasis.~   "
155585|NCT01529697|"~     Inhaled medications are the mainstay of the therapeutic management of respiratory disorders.~     Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are~     often improperly used. However, there is no tool that can detect and record errors in either~     the timing or the method dose administration~      The investigators designed a device that makes an acoustic record each time an inhaler is~     used. Opening the device makes an acoustic file which is recorded, this file is~     time-stamped which means that the timing of drug administration is recorded. When the~     device is retrieved and acoustic analysis performed, the steps involved in using the inhaler~     can be determined. Hence, the subjects inhaler technique is assessed and errors in the~     inhaler use identified. Together this means that errors in inhaler technique and timing of~     use can be quantified.~      In this study the investigators attached the device to a discus dry powder inhaler. In order~     to eliminate the behavioral component of adherence and identify the mechanical issues~     associated with effective inhaler use the investigators studied subjects who were already in~     Hospital and already prescribed a discus inhaler. The investigators hypothesized that the~     device would identify which errors in technique were the most common and that this would~     provide insight into how these errors might be eliminated.~   "
172216|NCT01310998|"~     The purpose of this study is to study the acute psychological effects in patients with~     schizophrenia after one session of high intensity exercise.~   "
155588|NCT01529658|"~     The Objective is to determine if renal hypothermia during open partial nephrectomy results in~     improved post-operative renal function compared to warm ischemia.~      Primary Aim is to determine the effect of hypothermia on preservation of overall renal~     function compared to no hypothermia in patients who require hilar vessel clamping during open~     partial nephrectomy for a renal tumor.~      Hypothesis: Hypothermia will result in improved post-operative preservation of overall renal~     function.~      Secondary Aim is to determine the effect of hypothermia on preservation of affected renal~     function (kidney with the tumor) compared to no hypothermia in patients who require hilar~     vessel clamping during open partial nephrectomy for a renal tumor.~      Hypothesis: Hypothermia will result in improved post-operative preservation of affected renal~     function.~   "
155589|NCT01529645|"~     This study will evaluate the safety and efficacy of 9 different vaccines containing aP~     (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy~     subjects 18 to 40 years of age.~   "
155590|NCT01529632|"~     The study assessed the safety and efficacy of the fixed combination product QVA149 versus the~     component products QAB149 and NVA237, administered concurrently, in patients that have~     moderate to severe chronic obstructive pulmonary disease (COPD).~   "
155591|NCT01529619|"~     This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine~     patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase~     Inhibitors.~   "
155592|NCT01529606|"~     The main objective of this entire research project is to develop a miniature atmospheric cold~     plasma brush (m-ACPB) for dental clinical applications. The objective of the clinical trial~     portion of the study is to compare the longevity and durability of dental composite~     restorations created using the plasma brush, to that of the standard care in dentistry for~     treating dental cavities, and effects on caries prevention.~   "
155593|NCT01529593|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to find the highest tolerable dose of the~     combination of temsirolimus and metformin that can be given to patients with advanced cancer.~     The safety of the drug combination will also be studied.~      Temsirolimus is designed to block a protein called mTOR (a protein that is thought to cause~     cancer cells to grow) inside the cancer cell. This may interfere with the growth or spread of~     cancer cells or possibly kill them.~      Metformin was designed to treat patients with diabetes. It may be able to block the protein~     mTOR and slow the growth of tumors.~      This is an investigational study. Temsirolimus is FDA approved and commercially available for~     the treatment of renal cell carcinoma. Metformin is FDA approved and commercially available~     for the treatment of diabetes mellitus. The combination of these drugs to treat advanced~     cancer is investigational.~      Up to 104 patients will take part in this study. All will be enrolled at MD Anderson.~   "
155594|NCT01529580|"~     This project will address a major challenge to the field of autism research: improving~     expressive communication in children with autism who have reached school age but have not~     acquired functional spoken language (non-verbal school aged children with autism; NVSACA).~      Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger~     site and follow-up testing but continue to have minimal functional spoken language will be~     participants in this study. After eligibility is established, participants will be randomly~     assigned to a baseline duration of one week, two weeks or three weeks before the start of~     active treatment. Once the baseline duration is completed, participants begin active~     treatment one hour of intervention three days per week in the participants' school setting.~     In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to~     improve the child's generalization of skills and teach parents the strategies implemented in~     their child's treatment. Post-baseline and post-treatment assessments will be completed in~     the lab at a time that is convenient for the participants' families.~   "
155595|NCT01529567|"~     Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral.~     They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both~     programs include mindfulness training, education about how excessive avoidant and control~     behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One~     of the programs also includes instructions on how to perform systematic exposure. The~     hypothesis of the study is while both groups will show improvement in terms of IBS symptom~     severity and quality of life, the addition of systematic exposure will lead to more~     improvement in symptoms.~   "
155596|NCT01529554|"~     Acute myocardial infarction (AMI) constitutes the major cause of death in most nations and~     death rates and morbidity remain substantial in the years thereafter. Inflammation is a~     hallmark throughout the distinct stages of atherosclerotic lesion formation preceding AMI as~     well as at the time of plaque rupture and during the post-infarct repair phase. Harnessing~     its harmful consequences constitutes an attractive therapeutic approach to address this unmet~     medical need.~      The objectives of this study are to evaluate the effects of mTOR inhibition (everolimus) on~     infarct size, myocardial function and inflammation in patients with ST-Elevation Myocardial~     Infarction.~      The efficacy objectives are:~        1. (1° endpoint):~           To assess the effect of mTOR inhibition (everolimus) on myocardial infarct size as~          change from baseline (12-72 hours after percutaneous coronary intervention) to 30 days~          follow-up measured by MRI (Late Gadolinium Enhancement (LGE) for transmurality).~        2. (2° endpoint):~           To evaluate microvascular obstruction (MVO) as change from baseline (12-72 hours after~          percutaneous coronary intervention) to 30 days follow-up evaluated by MRI.~        3. (3° endpoints):~             1. Change of left ventricular volume from baseline (12-72 hours after percutaneous~               coronary intervention) to 30 days follow-up measured by MRI.~             2. Change of biomarkers from time of coronary angiography to 30 days follow-up~               including a time-course (AUC). Biomarkers comprise hs-TnT, NT-proBNP, hs-CRP, IL-6~               and inflammatory biomarkers OPG, sRANKL, OPN and CCN1.~      The safety objectives are:~      To explore the effect of mTOR inhibition (everolimus) on several clinical and safety~     laboratory parameters including plasma lipid levels and blood count. This will be~     complemented by analysis of inflammatory cell subsets in coronary thrombi and peripheral~     blood (CD4+ T helper lymphocyte subsets, monocyte subsets).~   "
155597|NCT01529541|"~     This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by~     proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled~     with metformin alone.~   "
155598|NCT01529528|"~     This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice daily~     compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet~     therapy or combination of diet and exercise therapy.~   "
155599|NCT01529515|"~     The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month~     formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse~     of the symptoms of schizophrenia.~   "
155621|NCT01529229|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the treatment of Moderate - Severe Persistent Allergic~     Rhinitis.~   "
155601|NCT01529489|"~     Patients with chronic obstructive pulmonary disease (COPD) present slowed pulmonary oxygen~     uptake (VO2) and heart rate (HR) kinetics compared with age-matched controls. Patients with~     COPD present significant loss of body mass, decreased strength and endurance of respiratory~     muscles and lower limbs, leading reduced exercise capacity. This reduced exercise capacity~     can be marked by slowed kinetics of VO2 and HR at the onset of heavy-intensity exercise.~     Additionally, derangements in the diffusive and convective transport of oxygen to skeletal~     muscle mitocondria, and intramyocyte metabolic machinery, higher ventilation and disturbances~     in mechanics of breathing, hypoxemia, pulmonary hemodynamics, autonomic balance, and~     peripheral vasodilation, and accumulation of by-products that might be related to increased~     muscle fatigability could slow the response of systemic (central) and peripheral~     (microvascular) oxygen delivery to a point where the kinetics of VO2 might become limited by~     O2 availability and HR. Thus, the physical training programs of the lower limbs, in addition~     to presenting scientific evidence A, are important components, resulting in the reversal of~     the manifestations of COPD, resulting in improvement in exercise capacity, well significantly~     speeded VO2 and HR kinetics in patients with COPD. However, it should be taken into account~     the choice of an appropriate program limitations and severity of disease. Assuming that COPD~     patients present slower VO2 and HR kinetics, the investigators hypothesized that the~     heavy-intense interval physical training in equipament elliptical would promote a greater~     increase in the functionality (functional performance) and speeded kinetics in the cycle~     ergometer and elliptical equipment constant-load intense exercises tests of COPD patients. In~     this context, the present study intends to evaluate and compare the effects of resistive plus~     aerobic physical training and interval physical training on oxygen consumption (VO2) and~     heart rate (HR) kinetics responses at the onset in cycle ergometer and elliptical equipment~     constant-load intense exercises tests in patients with COPD.~   "
155602|NCT01529476|"~     1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with~          Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)~        2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients~          with CAP after continuous oral administration and determine the pharmacokinetic~          (PK)/pharmacodynamic (PD).~   "
155603|NCT01529463|"~     The purpose of this study is to test the hypothesis that a comprehensive post-discharge~     disease management system is more effective in reducing the readmission rate for heart~     failure patients compared to standard care.~   "
155604|NCT01529450|"~     This is a prospective single-center, open label, pilot study to investigate the safety and~     efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma.~      Primary Objectives:~      • To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals~     with locally advanced or metastatic BCC who have been previously treated with a non-LDE225~     Smo inhibitor.~      Secondary Objectives:~        -  To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (Gii~          1, 2, Patched 1,2 and Ki67) in individuals which are non-naive to Smo inhibitors other~          than LDE225, at baseline and at end-of-treatment~        -  To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225~          Smo inhibitor usage~        -  To assess the overall survival rates of individuals with locally advanced BCC or~          metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with~          LDE225~   "
155605|NCT01529437|"~     This is a study for children and adults who are interested in a new therapy for their~     allergies to dust mite and timothy grass. The new therapy is called sublingual immunotherapy~     and the investigators are testing if it is safe and well tolerated.~   "
155606|NCT01529424|"~     The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS~     ApoC-III Rx vs. Placebo on fasting total apoC-III levels.~   "
155607|NCT01529411|"~     This is a clinical trial to evaluate the efficacy and safety of the drug vinflunine~     administered after the standard treatment of the combination gemcitabine+cisplatin, when it~     has reached stabilization or response of the disease, as the first treatment inmeditely after~     the diagnosis of advanced or metastatic urothelial cancer.~   "
155608|NCT01529398|"~     People with knee osteoarthritis (OA) have functional instability and defective neuromuscular~     function, it was recently suggested that sensorimotor exercises may be important and needed~     to improve the effectiveness of training programs for these patients. This study objective~     was to compare the effectiveness of a supervised resistance muscular training (RT) versus~     sensorimotor training (SMT) for patients with Knee OA, on decrease of pain and functional~     improvement.~   "
155609|NCT01529385|"~     The purpose of this study is to determine whether a specially designed sock for people with~     diabetes and swelling in the legs can reduce the swelling, improve blood flow to the legs,~     and improve physical activity patterns of those individuals by providing mild compression to~     their legs.~   "
155610|NCT01529372|"~     The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be~     conducted on twenty (20) eligible patients with a twelve month follow-up period.~   "
155611|NCT01529359|"~     The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane~     Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).~   "
155612|NCT01529346|"~     The objective of this study is to evaluate the overall pain relief of a single dose of~     PF-05089771 against placebo following third molar extraction.~   "
155613|NCT01529333|"~     The purpose and objective of this study is to evaluate the safety and efficacy of the MET V~     System for the treatment of individuals with mixed hearing loss.~   "
155614|NCT01529320|"~     Determine the mean time to itch relief from the start of treatment with topic~     methylprednisolone aceponate.~   "
155615|NCT01529307|"~     This study will assess safety, tolerability, maximum tolerated dose or recommended dose for~     expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.~   "
155616|NCT01529294|"~     This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone~     in subjects with mild or moderate hepatic impairment comparatively to healthy matched~     subjects~   "
155617|NCT01529281|"~     It is well documented that exercise-induced muscle damage (EIMD) decreases muscle function~     and causes severe soreness and discomfort. Branched-chain amino acid (BCAA) supplementation~     has been shown to increase protein synthesis and decrease muscle protein breakdown, however,~     the effects of BCAAs on recovery from EIMD are unknown. Thus, the aim of this study was to~     examine the effects of a BCAA supplement on markers of muscle damage.~   "
155618|NCT01529268|"~     CyNCh is a multi-center, placebo-controlled clinical trial of children ages 8 to 17 years~     with biopsy-confirmed moderate to severe nonalcoholic fatty liver disease (NAFLD). The~     primary objective is to evaluate whether 52 weeks of treatment with cysteamine bitartrate~     delayed-release capsules will result in improvement in liver disease severity.~   "
155737|NCT01527708|"~     Primary objective of this study was to assess the intrasession, intersession and~     interobserver variability of the Pentacam-derived curvature and zernike coefficients in back~     surface of normal, keratoconic and crosslinked corneas.~   "
155622|NCT01529216|"~     The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System~     (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured~     as A1c, FBG and Post-Prandial Glucose levels.~      The study hypothesis is that HbA1c will show greater improvement in patients receiving 12~     months of therapy by the DIAMOMD System than in patients not receiving this therapy.~   "
155623|NCT01529203|"~     The aim of this study is to assess subjects' satisfaction linked to the pan facial management~     of rejuvenation with injections of Azzalure® and Restylane® fillers.~      This will be an open, multi-centre study.~   "
155624|NCT01529190|"~     Pregabalin, a ligand for alfa2delta subunits of voltage-gated calcium channels, has been~     shown to be an effective adjuvant therapy for acute postoperative pain, by inhibiting central~     sensitization. The IL-6, is detectable 60 minutes after surgical incision, persisting for~     until 10 days, with maximal plasmatic level in 4 and 6 hours. The objective of this study is~     evaluating the analgesic effect of pregabalin and its repercussion on serum levels of IL6.~   "
155625|NCT01529177|"~     Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic abnormalities~     and chronic hypospermatogenesis similar to women with polycystic ovarian disease (PCOD).~     Infertile men with unexplained infertility and IR may benefit from treatment with metformin.~   "
155626|NCT01529164|"~     Studies suggest that the addition of antiangiogenic agents to conventional therapeutic~     strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase~     clinical efficacy. For advanced colorectal cancer,the antiangiogenic agent bevacizumab has~     become an important treatment option and its combination with chemotherapy is now being one~     of the standard first line therapy. This phase II study was conducted to determine the~     efficacy and safety of another antiangiogenesis inhibitor rh-endostatin plus mFOLFOX6 in~     advanced colorectal cancer.~   "
155627|NCT01529151|"~     Western University of Health Sciences is seeking men and women to participate in a study on~     the effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation~     Therapy (VRT) in patients with vertigo. The purpose of this study is to examine the efficacy~     of OMT in the treatment of individuals with vertigo, alone and in combination with Vestibular~     Rehabilitation Therapy (VRT). Because of the health care costs associated with vertigo, the~     cost effectiveness of OMT and VRT will also be examined.~   "
155628|NCT01529138|"~     This study is being done to determine the highest safe dose of the combination of~     temsirolimus and axitinib; to learn the side effects when these drugs are given together; and~     to determine how the patient's disease responds to treatment.~      The combination of the drugs temsirolimus and axitinib has not been studied before so it is~     unknown whether this treatment will have any benefit in the patient's cancer.~      Temsirolimus is commercially available and approved for treatment of some types of kidney~     cancer.~      Axitinib has been tested in several diseases but it is not yet commercially available for the~     treatment of any cancer in the United States.~      The combination of temsirolimus and axitinib is not approved for treatment of any cancer~     outside of a clinical trial.~   "
155629|NCT01529125|"~     It is unclear whether children with HIV and severe acute malnutrition can be started on~     highly active antiretroviral therapy (HAART) safely while they are still malnourished and the~     manner in which this therapy should start. This study will examine the safety, efficacy, and~     metabolism of children started on HAART while still severely malnourished.~   "
155630|NCT01529112|"~     The purpose of this study is to compare the overall survival of patients receiving E7080 +~     Best Supportive Care (BSC) with those receiving placebo + Best Supportive Care.~   "
155631|NCT01529099|"~     This is a postmarketing study to assess the overall performance and survivorship of the SIGMA~     HP® PARTIAL KNEE SYSTEM.~   "
155632|NCT01529086|"~     The REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident~     prostate cancer, as detected on biopsy, among men who are at increased risk for the disease.~     Dutasteride was compared with placebo for 4 years period. Results showed a relative risk~     reduction of 22.8 % (95% CI: 15.2 to 29.8)in prostate cancer.~      For REDUCE, biopsies were defined as protocol biopsy if performed at certain timeframes,~     and for cause if outside these predetermined timeframes.~      The investigators propose a post hoc analysis that would allow them to include biopsies that~     really justified a clinical indication, but were excluded from for cause analysis based on~     occurring at either the 2 or 4 year timeframes.~      Thus the investigators propose analysis of both REDUCE groups by every yearly timeframe as:~      Group 1--dutasteride group biopsied for cause using several definitions: biopsy of patients~     who received dutasteride whose PSA rose from nadir as defined in your own protocol,who had a~     PSA rise>0.2 ng/ml or who had a new abnormal DRE or had a free PSA<12% . The investigators~     define these as such because this would reasonably instigate biopsy if the clinician had a~     patient with this scenario in the non-study setting.~      Group 2--placebo group biopsied for cause using several definitions, regardless of~     timeframe but reported at each year of the study and aggregate, with the aggregate number~     being the primary outcome. Thus the investigators would request results of biopsy of patients~     who received placebo To establish differences in biopsy positive rates the groups as per each~     definition listed, to determine if dutasteride decreased the likelihood of for cause biopsy~     compared to not for cause biopsy, and if there is a difference in cancer detection risk~     rate depending on cause vs. no cause in that group compared to placebo.~   "
155633|NCT01529073|"~     Objectives: 1. Primary objective: To Evaluate the rate of sustained virological response~     (SVR) of pegylated interferon alfa-2b (Peg-IFN) plus ribavirin (RBV) plus nitazoxanide (NTZ)~     in patients coinfected by HIV and HCV genotype 4 (HCV-4), never treated before (naïve) and~     with a treatment failure to a standard therapy with Peg-IFN plus RBV (experienced), and to~     compare it with the rate of SVR of these patients with Peg-IFN plus RBV is a historical~     cohort. 2. Secondary objectives: In naive, as well as in experienced patients: a) To evaluate~     the virological activity at weeks 4 and 12 after starting the combination of Peg-IFN plus RBV~     plus NTZ in HIV/HCV-4-coinfected patients. b) To analyze the safety of Peg-IFN plus RBV plus~     NTZ in HIV/HCV-4-coinfected patients.~      Design: Pilot clinical trial without control to evaluate efficacy and safety (phase II).~      Patients: Individuals with HIV infection and with confirmed chronic HCV infection.~      Treatment: NTZ 500 mg every 12 hours during 4 weeks, followed by NTZ 500 mg every 12 hours~     plus Peg-IFN plus weigh-adjusted RBV for 48 weeks. Total duration of therapy: 52 weeks.~      Primary variable: The proportion of patients with HCV RNA ≤10 IU/ml 24 weeks after finishing~     the programmed length of treatment.~      Secondary variables: 1. The frequency of individuals with HCV RNA ≤10 IU/ml 12 weeks after~     finishing the programmed length of treatment. 2. The proportion of patients with HCV RNA ≤10~     IU/ml at 4 and 12 weeks after adding PegIFN plus RBV to NTZ. 3. The frequency of severe~     adverse events.~   "
155703|NCT01528150|"~     The purpose of this observational study is the assessment (safety and efficacy) of the St.~     Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™~     System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population~     includes patients with a standard bradycardia pacing indication.~   "
155634|NCT01529060|"~     The investigators have learned in past research that the drug phenylbutyrate can decrease the~     amounts of branched chain amino acids and their byproducts in the bloodstreams of healthy~     volunteer patients and also patients with certain disorders of protein breakdown including~     maple syrup urine disease. Through this study, the investigators will try to find out how~     well phenylbutyrate (NaPBA), also known by name brand Buphenyl-TM, decreases BCAA and~     branched chain keto chain acids in the blood of patients with MSUD. The investigators hope is~     that through this research the investigators will be better able to treat these patients.~      Subjects with MSUD will take phenylbutyrate (NaPBA) in powder form for a two-week treatment~     period and powder placebo, a substance with no effect on the body, for a two-week treatment~     period. They will be given the same amount of powder and undergo the same laboratory testing~     during both of the two-week treatment periods. The results will be compared once the study is~     over.~   "
155635|NCT01529047|"~     Rates of gambling and substance use behaviors are elevated among emerging adults (ages~     18-24), and these behaviors are individually and jointly associated with a host of negative~     consequences. Evidence suggests there is significant overlap between these behaviors as well~     as comorbidity of associated mental disorders (i.e., pathological gambling and substance~     abuse/dependence). Prior research suggests that a brief in-person delivered personalized~     feedback intervention (PFI) may be an effective method of reducing these behaviors and their~     associated consequences among emerging adults. Thus, the purpose of this study is to~     determine the relative efficacy of an in-person delivered PFI versus a Web-based PFI in~     reducing gambling, alcohol and marijuana use behaviors and related-consequences in a sample~     of emerging adults, as well as explore potential moderators and mediators of intervention~     efficacy and the longevity of intervention effects (over a period of 18-months).~   "
155636|NCT01529034|"~     The purpose of this study is to examine the long-term safety and tolerability of USL261 in~     the treatment of seizure clusters.~   "
155637|NCT01529021|"~     Millions of children in North America receive an annual flu vaccination, many of whom are at~     risk of experiencing severe distress. Children frequently use technologically advanced~     devices such as computers and cell phones. Based on this familiarity, the investigators~     introduced another sophisticated device - a humanoid robot to- interact with children during~     their vaccination. The investigators hypothesized that these children would experience less~     distress than children who did not have this interaction.~   "
155638|NCT01529008|"~     Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of~     the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction.~     Core decompression is currently the treatment of choice for early stage osteonecrosis of the~     femoral head. This method consists in decompressing the rigid intra-osseous chamber to~     promote revascularization, thus halting progression of the disease and stimulating repair.~     Still this treatment remains highly controversial, since the success rates of the first~     studies have not been repeated.~      The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated.~     Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures,~     microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells~     recruitment.~      Three studies have indicated the potential clinical benefits of cell-based approaches for the~     treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004).~     This is on the basis of these observations that a proprietary population of autologous~     osteoblastic cells (PREOB®) has been developed.~      This Phase 3 study aims at demonstrating the efficacy and safety of PREOB® in the treatment~     of early stage osteonecrosis of the femoral head. More specifically, the purpose of the study~     is to demonstrate that core decompression/PREOB® implantation into the necrotic lesion is~     superior to core decompression/placebo implantation in relieving hip symptoms and halting (or~     reverting) radiological progression of the disease.~   "
155639|NCT01528995|"~     Fecal incontinence (FI), the involuntary loss of solid or liquid stool, is a stigmatising~     condition. It can have a distressing impact and restriction on quality of life.~     Obstetric-related fecal incontinence may occur early after childbirth. Previous obstetric~     injury is a major cause of fecal incontinence in older women.~      When conservative treatment fails, surgery may be an option. Both sacral nerve modulation and~     anal bulking injections is minimal invasive surgical alternatives. Step one in SNM is a trial~     period of temporary stimulation. If the test is successful, the patient can have an~     implantable stimulator (step 2). Transanal submucosal bulking injection of collagen is also a~     possible treatment option and can be an effective treatment for faecal incontinence.~      The purpose of this study is to compare the efficacy of sacral nerve stimulation to anal~     bulking injections in women with fecal incontinence after obstetric sphincter injuries~     (OASIS), through a multicenter blinded, randomized controlled trial.~   "
155640|NCT01528982|"~     The goal of this study is to assess the risk factors for the development of pathological~     gambling.~   "
155641|NCT01528969|"~     1. The present controlled, randomized, doubleblind study aims to answer the following~          questions:~             -  How will the normal flora be affected by the xylitol consumption?~             -  Will daily consumption of xylitol change the plaque-saliva distribution of the~               mutans streptococci?~             -  The association of the test results will also be compared with the caries status at~               the baseline.~        2. About eighty subjects with MS counts of log CFU 5 or more will be identified and invited~          to the study. They will be randomly divided into a Xylitol and Sorbitol group.~        3. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be~          collected before and after gum use.~        4. Studying and quantifying of 16 bacterial species belonging to the normal flora by~          DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora~          in general.~   "
155642|NCT01528956|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies genes in samples from younger patients with~     adrenocortical tumor.~   "
155643|NCT01528943|"~     The purpose of this study is to investigate the effect of continuous perioperative infusion~     of prostacyclin on haemostasis and endothelial functionality in patients undergoing major~     abdominal surgery.~   "
155794|NCT01526941|"~     This trial is conducted in Europe. The aim of this trial is to compare the single dose and~     steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in~     subjects with type 1 diabetes.~   "
155644|NCT01528930|"~     The incidence of chronic pulmonary disease caused by nontuberculous mycobacteria (NTM) in~     human immunodeficiency virus (HIV)-negative patients has been increasing worldwide. In Korea,~     the common etiologic pathogens for this disease are Mycobacterium avium complex (MAC) and~     Mycobacterium abscessus. Treating NTM lung diseases can be extremely difficult and may~     require multiple drugs.~      Amikacin is an effective antibiotic for NTM infection. However, intravenous amikacin~     treatment is limited by its systemic route of administration and a lot of adverse events.~     Amikacin inhalation treatment could overcome these limitations and also could be effective~     for treatment of NTM pulmonary disease due to maintaining a high lung concentration. The~     purpose of this study is to determine whether amikacin inhalation treatment is effective in~     patients with MAC infection who experienced treatment failure after standard treatment for~     more than 6 months or with M. abscessus infection.~   "
155645|NCT01528917|"~     This is a Natural History study to characterize key aspects of the clinical course of late~     onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD).~   "
155646|NCT01528904|"~     The purpose of this trial is to correlate fetal thyroid hormones from fetal cord blood with~     clinical (maternal antithyroid drug dose and antithyroid antibodies) and ultrasound (US)~     parameters of fetal thyroid function from pregnant mothers with autoimmune thyroid disease~     (AITD).~   "
155647|NCT01528891|"~     To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of~     Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus~     Injection of Dexmedetomidine.~   "
155648|NCT01528878|"~     The purpose of this study is to determine a tolerable dose of radiation delivered by the~     CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC).~   "
155649|NCT01528865|"~     Therapy for non-Hodgkin lymphoma (NHL) is in evolution as new molecular pathways and targeted~     therapies are identified. Although most NHLs respond to currently available therapies, the~     majority of patients relapse and many never have a complete response to therapy. In the~     investigators attempts to further understand the pathogenesis of NHLs, the investigators have~     identified and characterized expression of human endogenous retroviruses (HERVs) at the DNA,~     RNA and protein levels in association with the presence of NHLs (and other neoplastic~     diseases). The investigators preclinical evidence suggests a correlation with the level of~     HERV-K (a particular family of HERVs) expression and NHL disease activity, leading us to~     hypothesize that HERV-K expression may contribute to the development of the disease and/or to~     its recurrence. If this hypothesis is correct, then drugs that inhibit HERV-K expression may~     prevent recurrence of disease and/or may provide a novel therapeutic approach for NHLs.~      To test this hypothesis, the investigators eventually intend to study the use of~     anti-retroviral therapies in patients with NHL. The investigators in vitro studies have~     demonstrated that HERV-K expression decreases in response to the currently FDA-approved and~     available, anti-HIV drugs, Lamivudine and tenofovir disoproxil fumarate (tenofovir). These~     medications are tolerated well in HIV patients, but it is unknown how the combination of~     Lamivudine and Tenofovir will be tolerated by patients with NHL. To further test the~     investigators hypotheses, the investigators propose the following Specific Aims of the~     current study: (1) To evaluate the tolerability, toxicity and safety of administering~     Lamivudine and Tenofovir in combination to patients with relapsed or refractory NHL; (2) To~     evaluate the effects of the combination of lamivudine and tenofovir on HERV-K plasma viral~     RNA load; and (3) To monitor the response rate of the NHL to treatment with the combination~     of lamivudine and tenofovir.~      The investigators study will recruit adult patients with relapsed or refractory NHL whom the~     investigators have identified as having expression of HERV-K. Volunteer participants will be~     administered the combination of lamivudine and tenofovir and monitored for tolerability,~     toxicity, compliance, changes in viral RNA load and disease response.~   "
155650|NCT01528852|"~     In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine~     cleansing solution on umbilical cord of infants in first 10 days of life results in~        -  Reduction in neonatal mortality (deaths in first 28 days of life)~        -  Reduction in umbilical cord infections (defined by moderate or severe redness of the~          cord) during first 28 days of life~        -  Reduction in umbilical cord infections (defined by pus formation with any degree of~          redness) during first 28 days of life.~      The double blind part of study uses a control preparation without chlorhexidine (CHX) as~     control group while in the sub-study dry cord care group is also evaluated as second control.~     Hypothesis is that CHX group will have lower mortality and umbilical cord infections while~     control group and dry cord group will be similar as shown in a previous study in Nepal.~   "
155651|NCT01528839|"~     There is growing evidence that thyroid axis dysfunction may contribute to the pathophysiology~     of bipolar illness. Open-label studies have consistently demonstrated that the behavioral~     expression of bipolar disorder can be modified by a change in thyroid status, and in many~     instances the course of illness is improved through the use of adjunct thyroid hormone~     treatment. Recent evidence emerged from acute intervention studies that add-on treatment with~     supraphysiological doses of levothyroxine is an effective augmenting agent in patients with a~     major depressive episode. The primary goal of this international multicenter trial (5 sites)~     is to determine in a 13-week, randomized, placebo-controlled design (1 week single-blind~     placebo run-in, 6 week double-blind, 6 week open-label) the efficacy and safety of add-on~     treatment with levothyroxine (300 mcg/d) in combination with mood stabilizer/antidepressant~     therapy in the treatment of patients with bipolar depression. The main hypotheses is:~     treatment with levothyroxine will result in a significantly greater mean reduction of HRSD~     total score and in a higher number of responders and remitters compared to placebo treatment.~     This proposal will build on our pilot data and provide evidence for the use of levothyroxine~     as an effective augmentation strategy in the treatment of bipolar depression.~   "
155652|NCT01528826|"~     The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus~     oxaliplatin in pretreated metastatic triple-negative breast cancer.~   "
155653|NCT01528813|"~     The study aims to investigate the effectiveness of a single application of Er:YAG laser to~     the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of~     onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial~     respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a~     kind of onychomycosis that does not affect the ungual matrix). The patients will receive~     treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment~     by means of the clearance of nail plate infection.~   "
155654|NCT01528800|"~     The purpose of this study is to see if vitamin K supplementation three times per week reduces~     the progression of coronary artery calcification over 12 months in dialysis patients compared~     to placebo?~   "
155655|NCT01528787|"~     In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized~     to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye),~     once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be~     administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated~     in the clinic throughout the study.~   "
158559|NCT01490645|"~     The purpose of the study is to analyse patient's acceptance and willingness to participate in~     a Structured Care Program (SCP) over 12 months following hospital discharge after Acute~     Coronary Syndrome (ACS) index event.~   "
155656|NCT01528774|"~     The purpose of this study is to determine if circulating tumor cells (CTC) can be accurately~     detected and isolated from the blood of participants with melanoma using novel laboratory~     techniques. Blood samples will be collected from participants with melanoma, and also from~     participants with other solid tumor cancers and healthy volunteers for purposes of~     comparison.~      Relevant information will be collected from participant's medical record and stored in a~     coded manner in a password-protected format. This information will be used to look for~     correlations of research results on blood samples to participant's medical condition. Test~     results will not be given to participants or their physicians. In some cases, CTC may be~     grown for long-term cell lines for further research.~   "
155657|NCT01528761|"~     The purpose of this 12-month study is to compare how well two programs help older adults make~     physical activity a regular habit.~   "
155658|NCT01528748|"~     This study examines the effectiveness of Cognitive Behavioral Analysis System of~     Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults~     who are chronically depressed and alcohol dependent.~   "
155659|NCT01528735|"~     The objective of this trial is to investigate tolerability, safety, pharmacokinetics and~     antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks~     in Japanese treatment-naive patients with chronic GT-1 HCV infection.~   "
155660|NCT01528722|"~     Laparoscopic cholecystectomy (removal of the gall bladder via 'keyhole surgery') is a common~     procedure. This can be performed as an emergency operation when a patient has a complication~     of gall stones such as acute inflammation or pancreatitis. There are several trials which~     demonstrate that placing local anaesthetic inside the abdomen at the site of gall bladder~     surgery during a planned elective operation decreases post operative pain. This is the first~     trial to investigate the efficacy of this local anaesthetic during emergency cholecystectomy.~   "
155661|NCT01528709|"~     During coronary artery bypass graft surgery (CABG), saphenous vein from the leg is used to~     bypass the atherosclerotic blockages in the arteries of the heart. Unfortunately, vein~     bypasses themselves develop blockages over time, a process termed saphenous vein graft~     disease. By lowering cholesterol levels in the blood, statin medications are used after~     surgery to prevent the development of atherosclerotic blockages in the vein bypasses.~     Recently, higher doses of statin medications have been introduced, with some studies showing~     that they are more effective than traditional doses when used in heart attack patients.~     Furthermore, laboratory tests have shown that higher doses of statin medications can slow the~     development of atherosclerosis. Despite these benefits, very little is known regarding the~     use of high-dose statin therapy after bypass surgery in humans.~      The goal of this study will be to see if high-dose statin therapy will prevent the~     development of vein graft occlusion during the first year after bypass surgery. Patients will~     be randomized to receive either high-dose statin therapy or conventional moderate-dose statin~     therapy starting within 4 days of surgery and continuing for the duration of one year after~     the operation. The statin medication will be given in capsule form. During the course of this~     study, neither the patient nor the health care team will know which treatment each patient is~     receiving. One year after bypass surgery, a computed tomography (CT) coronary angiogram will~     be performed to evaluate the patency of the vein bypasses.~   "
155662|NCT01528696|"~     Obese patients undergoing cesarean section are at high risk for wound complications, which~     occur in approximately 20% of patients. This is a randomized controlled trial designed to~     determine whether the risk for wound-related complications can be reduced by covering the~     incision with a silver-impregnated dressing in the postoperative period.~   "
155663|NCT01528683|"~     Treatment standard for patients with rectal cancer depends on the initial staging and~     includes surgical resection, radiotherapy as well as chemotherapy. For stage II and III~     tumors, radiochemotherapy should be performed in addition to surgery, preferentially as~     preoperative radiochemotherapy or as short-course hypofractionated radiation. Advances in~     surgical approaches, especially the establishment of the total mesorectal excision (TME) in~     combination with sophisticated radiation and chemotherapy have reduced local recurrence rates~     to only few percent. However, due to the high incidence of rectal cancer, still a high~     absolute number of patients present with recurrent rectal carcinomas, and effective treatment~     is therefore needed.~      Carbon ions offer physical and biological characteristics. Due to their inverted dose profile~     and the high local dose deposition within the Bragg peak precise dose application and sparing~     of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an~     increase relative biological effectiveness (RBE), which can be calculated between 2 and 5~     depending on the cell line as well as the endpoint analyzed.~      Japanese data on the treatment of patients with recurrent rectal cancer previously not~     treated with radiation therapy have shown local control rates of carbon ion treatment~     superior to those of surgery. Therefore, this treatment concept should also be evaluated for~     recurrences after radiotherapy, when dose application using conventional photons is limited.~     Moreover, these patients are likely to benefit from the enhanced biological efficacy of~     carbon ions.~      In the current Phase I/II-PANDORA-01-Study the recommended dose of carbon ion radiotherapy~     for recurrent rectal cancer will be determined in the Phase I part, and feasibility and~     progression-free survival will be assessed in the Phase II part of the study.~      Within the Phase I part, increasing doses from 12 x 3 Gy E to 18 x 3 Gy E will be applied.~      The primary endpoint in the Phase I part is toxicity, the primary endpoint in the Phase II~     part its progression-free survival.~   "
155664|NCT01528670|"~     The purpose of this clinical study is to investigate the clinical feasibility and~     effectiveness of off-line Positron-Emission-Tomography (PET) quality assurance for promoting~     the accuracy of proton and carbon ion beam therapy. One main clinical advantage of ion~     therapy over conventional radiation therapy is the excellent conformation of the delivered~     dose to the tumour volume while well sparing the surrounding healthy tissue. However,~     clinical exploitation of this potential to the maximum extent requires in-vivo validation of~     the actual treatment delivery and, in particular, of the ion beam range within the patient.~     Since the primary ions are completely stopped in the target volume as opposed to photon~     radiation, no conventional quality assurance techniques like transmission electronic portal~     imaging can be applied to monitor ion beam therapy. Hence, ion treatment planning currently~     relies on models and experimental data accurately validated in tissue-equivalent targets, but~     no direct verification of the actual treatment delivery and of the ion beam range within the~     patient is possible in standard clinical practice.~      At present, PET offers the unique possibility to monitor the precision of ion irradiation~     in-vivo and non-invasively. The method is based on the detection of the b+-activity which is~     formed as a by-product of the irradiation, i.e. without administration of radio-tracers to~     the patient. A positive clinical impact of in-beam (i.e. during the irradiation) PET~     monitoring has been demonstrated for carbon ion therapy in the pilot project at GSI~     Darmstadt, Germany, and promising clinical data of post-radiation PET/CT imaging have been~     recently reported for passive proton beam delivery in USA and Japan. Therefore, a pilot~     clinical study is hereby proposed at the Heidelberg Ion Therapy Center in order to 1) assess~     the applicability of post-radiation PET imaging to scanned ion beam delivery, 2) identify the~     patient population which may benefit from it and 3) extract population-based information on~     the reliability of the beam range in different tumour locations for all the ion species~     clinically available at HIT.~      The investigated patients are expected to benefit from this study, since in case of detected~     deviations between planned and actual treatment delivery a proper correction could be applied~     in the next irradiation fraction, assuring an overall better treatment than without any~     monitoring. Moreover, site-specific patient-population information on the ion range precision~     at HIT might enable improvement of the CT-range calibration curve as well as safe reduction~     of the treatment margins to promote enhanced treatment plan conformality for full clinical~     exploitation of the promises of ion beam therapy.~   "
155704|NCT01528137|"~     This phase I trial studies how well talactoferrin works in treating patients with relapsed or~     refractory non-small cell lung cancer (NSCLC) or squamous cell head and neck cancer.~     Biological therapies, such as talactoferrin, may stimulate the immune system in different~     ways and stop tumor cells from growing~   "
155665|NCT01528657|"~     The objective of this study is to intra-individually compare the performances of two~     pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic~     Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare~     ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of~     atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted~     with a pacemaker for Sick Sinus Syndrome.~   "
155666|NCT01528644|"~     Iron deficiency anaemia affects around two billion people worldwide. Food fortification with~     iron is a realistic way to combat this problem. Water soluble forms of iron are considered to~     be more bioavailable than nonsoluble iron compounds. However, the former often cause sensory~     problems when added to foods, while the latter cause fewer problems but are not generally~     well absorbed and are therefore ineffective as fortificants. A potential strategy for~     overcoming this problem is the use of water soluble iron compounds protected by a water~     resistant barrier, which will prevent potential organoleptic changes within fortified foods~     and protect the iron (from oxidation) through the digestion process thus increasing its~     availability. The investigators will use alginate, in the form of alginate beads, as a~     protective barrier for soluble iron gluconate. It has been shown that alginates bind divalent~     and trivalent cations and therefore may be a useful vehicle for soluble iron compounds to~     fortify foods.~      The aim of this project is to measure the effect of alginate on iron absorption from ferrous~     gluconate and assess the potential modulating effect of calcium on iron absorption in the~     presence and absence of alginate.~   "
155667|NCT01528631|"~     The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to~     sucrose in men.~   "
155668|NCT01528618|"~     The present study will be a randomized, control, multicenter phase III study of recurrent or~     metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and~     cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). The population consists~     of recurrent or metastatic nasopharyngeal carcinoma (NPC) that failed the radical~     radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side~     effects will be evaluated according to Standard WHO response criteria and NCI-CTC AE V3.0.~   "
155669|NCT01528605|"~     This study is to investigate the protective effects of supplemental lutein and zeaxanthin on~     early age-related macular degeneration (AMD) patients in China.~   "
155670|NCT01528592|"~     Based on studies showing better responsiveness of motor versus cognitive symptoms to~     Parkinson's Disease medication, also known as dopaminergic treatments, the investigators~     hypothesize that comparison of resting state networks in the on versus off medication state~     in Parkinson's Disease patients will show greater effects on brain networks associated with~     motor control.~   "
155671|NCT01528579|"~     Background:~      Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated~     Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and~     personal sufferings there are only a few prospective randomized studies (RCT) in patients~     with chronic WAD, and none of them evaluating return to work, or the role of neck specific~     exercises with or without a combination of a behavioral approach compared with prescribed~     physical activity.~      Aim:~      The general aim of this RCT is to examine what neck-specific training with or without a~     combination with behavioral approach adds to prescribed physical activity of persons with~     chronic WAD with regard to pain intensity, physical and psychological function, health care~     consumption and return to work. Another aim is to study predictive factors of importance for~     a good outcome of rehabilitation.~      Method:~      After informed consent patients in age 18-63 years of age with WAD II-III with more than 6~     months duration will be randomized to one out of the three alternatives of physiotherapy,~     treatment with medical exercise therapy with neck specific exercises (A),treatment with a~     behavioral approach combined with neck specific exercises (B), prescribed physical activity~     (C). Randomisation will be done by the central project leader. 200 patients will be included~     in the study. All physiotherapists engaged in the structured and well described treatment~     will be introduced in the program by the project leader. The measurements with good~     clinometric properties will be performed before treatment, after 12 weeks, 6, 12 and 24~     months after inclusion into the study. Clinical measurements will be performed by a blinded~     investigator. Background data, disease-specific and generic data will be measured by~     self-evaluated answered questionnaires by the patients. Days of sick-leave will be collected~     from the Social Insurance Agency. Main outcomes of the measurements are pain intensity, neck~     specific disability and return to work. Cost-effectiveness will be calculated.~   "
155672|NCT01528566|"~     This is the first study to test the effect of Tai Chi on pain from knee osteoarthritis in~     community-dwelling elders with mild cognitive impairment. If Tai Chi is effective in reducing~     pain, clinicians can use it routinely with this population; then elders can maintain their~     functional ability longer, and perhaps delay or prevent long-term care admission, and the~     investigators can save health care dollars.~   "
155673|NCT01528553|"~     In children with excessive knock knees it may be necessary to use guided growth (small~     surgical procedure) so the child outgrows the condition before maturity. A new implant is on~     the market and the investigators compare this implant (8plate) with the old technique~     (staples) in a randomised setup.~      The hypothesis is that the 8plate provides a faster correction rate and that this treatment~     is superior to stapling.~   "
155674|NCT01528540|"~     Study hypothesis: Combination of antioxidants and pregabalin results in better pain relief~     than placebo in patients with chronic pancreatitis.~      Chronic pancreatitis (CP) is a clinical enigma, with pain being the most distressing symptom~     that brings the patient to clinical attention. Pain in chronic pancreatitis is~     multifactorial, and may be related to pancreatic ductal hypertension, tissue hypertension,~     inflammatory cytokines, oxidative stress and neuropathic mechanisms like mechanical~     allodynia, inflammatory hyperalgesia and temporal summation. The mainstay of treatment for~     pain in CP due to pancreatic ductal stone is endotherapy (ESWL and ERCP). Recent randomized~     controlled trials have shown that antioxidant cocktail and pregabalin (a presynaptic voltage~     gated calcium channel blocking agent) can result in significant reduction of pain in CP.~      In this study, the investigators will study the efficacy of the combination of antioxidants~     and pregabalin in reducing pain and compare that with placebo. The investigators will~     randomize patients with documented chronic pancreatitis with recurrent/persistent pain after~     undergoing endotherapy and ductal clearance into three groups: Group A- antioxidants +~     pregabalin; Group B- Placebo. The primary outcome will be change in pain score and the~     secondary outcomes will be change in the number of painful days, analgesic requirements,~     quality of life and depression scale. Pain score will be quantified by the Izbicki pain score~     and visual analog scale; while quality of life and depression will be measured by the EORTC~     QLQ-C30/PAN26 and Beck depression inventory respectively. Comparison between Group A vs B~     will be made by the Chi square test/Fischer Exact and the Student's 't' tests respectively~     and analysis will be done on a intention to treat and per protocol basis. With an expected~     improvement of pain by 40% (at 80% power and alpha of 0.05) and adjusting for a presumed 10%~     drop out rate, the required sample size in each group will be at least 40.~   "
155675|NCT01528514|"~     It is well-established that myocardial infarction (MI) associated with coronary artery bypass~     graft surgery (CABG) predicts the poor outcome. Nevertheless, the cardioprotective therapies~     to limit myocardial injury after CABG are lacking. Previous studies have shown that~     curcuminoids suppress pro-inflammatory cytokines during cardiopulmonary bypass surgery and~     decrease the occurrence of cardiomyocytic apoptosis after cardiac ischemia/reperfusion injury~     in animal models. The investigators aim to evaluate whether curcuminoids prevent MI after~     CABG, compared to placebo.~   "
155676|NCT01528501|"~     This is an open-label, phase II trial evaluating the antitumor activity and safety of the~     oral Histone Deacetylase (HDAC)-Inhibitor LBH589. The treatment consists of 20 mg LBH589~     three times a week in patients with chemo-refractory HDAC overexpressing.~      metastatic adenocarcinoma of stomach, esophagogastric junction or lower esophagus (Barrett~     carcinoma). One cycle lasts 21 days. A total of 28 patients will be enrolled in this trial.~     In patients experiencing LBH589-related toxicity requiring treatment rest or dose reduction~     dose may be reduced. Subsequent dose adjustment will be permitted based on outcome. Treatment~     will continue until disease progression or intolerable adverse events. Subsequently, the~     patients will be followed-up for one year.~   "
155677|NCT01528488|"~     The epidermal growth factor receptor (EGFR) has become an important target for cancer~     therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an~     important role in the treatment of non-small cell lung cancer (NSCLC). What accompanies with~     the encouraging efficacy in NSCLC is the common side effects, of which the most common one is~     the specific papular and pustular acne-like rash which affects mainly the face, scalp, and~     upper torso. But till now, no medicament has been proved effective enough to treat or prevent~     the EGFR-TKIs associated rash. The EVOZAC® Calming Skin Spray has shown acceptable activity~     at the rash prevention in our preliminary study, so the investigators conduct the randomized,~     double-blind, controlled trial to evaluate the efficacy and safety of EVOZAC® Calming Skin~     Spray in prevention of EGFR-TKIs associated rash in NSCLC.~   "
155678|NCT01528475|"~     This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of~     therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional~     post-resuscitation care. The goal of this trial is to increase the proportion of cardiac~     arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to~     reach the target body temperature within 6 hours of hospital arrival. The investigators~     believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians~     to continue therapeutic hypothermia, and will lead to care improvements across a health~     system.~   "
155679|NCT01528462|"~     The aim of the investigators was to determine whether the immediate management of any~     detected sleep disorders can improve outcomes in patients who have had a transient ischemic~     attack (TIA) or minor stroke. This group of patients is at high risk for having a recurrent~     stroke or TIA, and the investigators would like to investigate new ways of preventing~     potentially avoidable events. The treatment of sleep disorders immediately after a stroke or~     TIA may prove to be a novel method of avoiding future strokes and improving outcomes.~   "
155680|NCT01528449|"~     Both prospective and retrospective (look back) study of blood donors for laboratory evidence~     of babesia microti infection.~      Two laboratory methodologies will be utilized:~        1. - PCR, to look for the presence of B.microti in whole blood~        2. - IFA, to look for significant titers of B.microti antibody~   "
155681|NCT01528436|"~     This randomized controlled study aims to evaluate the efficacy of umbilical cord blood~     therapy for children with cerebral palsy.~   "
155682|NCT01528423|"~     The research is intended to evaluate the short-term reproducibility of the XtremeCT device~     for measurements of peripheral bone density and bone structure in population-based volunteers~     from different age groups and to compare the XtremeCT with current peripheral quantitative~     computed tomography (pQCT) technology. The investigators will also assess the correlation~     between XtremeCT measurements of bone structure with hormones and biochemical markers of bone~     turnover.~   "
155683|NCT01528410|"~     This is a multicentre, open, randomised, and controlled trial conducted in sixty (60)~     patients diagnosed with refractory or recurrent ascites. Patients will be randomised~     (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm~     B-standard of care with evacuation large volume paracentesis. The main aims of the study are~     to determine the paracentesis free survival, defined as the time to the first large volume~     therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of~     cirrhosis-related complications in the group of patients randomized to the ALFApump system~     group, as well as nutritional effects, resource utilisation, patient quality of life and~     survival non-inferiority.~   "
155684|NCT01528397|"~     A proper digital nerve (PDN) defect in the thumb can produce partial or complete sensory loss~     which can result in functional disability. This article reports the treatment of the thumb~     PDN defect using a pedicled nerve graft harvested from the dorsal branch of the PDN. Fourteen~     patients with the thumb PDN defect underwent a new surgical procedure in which the pedicled~     nerve graft was used to bridge nerve defect. For comparison, the investigators also collected~     a consecutive series of 21 patients with thumb PDN defects treated using a nonvascularized~     sural nerve graft. This study was designed to evaluate the efficacy of pedicled nerve~     grafting for PDN defects in the thumb.~   "
155685|NCT01528384|"~     This is a phase 1 study of pegylated arginine deiminase (ADI-PEG 20) in pediatric patients~     who deficient in the expression of tumor argininosuccinate synthetase, and have failed prior~     treatments. The study hypothesis is that this drug will be safe in pediatric patients.~   "
155686|NCT01528371|"~     Intravenous sedation was used for dealing with transient hypertension, so-called white-coat~     hypertension, before dental treatment. Midazolam used as a sedative also has antianxiety~     effect, and the mechanism is guessed that it minimizes patients' stress, resulting in the~     stability of blood pressure. The purpose of this randomized controlled trial (RCT) is to~     evaluate the effect of low dose of midazolam on blood pressure and anxiety scale in~     white-coat hypertensive dental patients.~   "
155705|NCT01528124|"~     This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and~     tolerability of the study drug in healthy people and investigate how much of the study drug~     gets into the blood stream and how long it takes the body to get rid of it. Information about~     any side effects that may occur will also be collected.~   "
155706|NCT01528111|"~     This Phase 1/2a study is intended to assess the safety, tolerability, and effects on~     intraocular pressure of two dose levels and two dose frequencies of LX7101 when administered~     topically in the eyes of patients diagnosed with primary open-angle glaucoma or ocular~     hypertension.~   "
155707|NCT01528098|"~     The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus~     bisacodyl versus PEG alone for bowel preparation in hospitalized patients.~   "
155687|NCT01528358|"~     Hypotheses:~        1. In the acute phase of early illness, tissue oxygen saturation and vascular occlusion~          test (VOT) are important adjuncts in differentiating severe critical illness requiring~          ICU admission from patients benefiting from less aggressive therapies (non-ICU~          admission).~        2. An early feature of severe sepsis is abnormal microcirculatory vasoreactivity.~        3. Microvascular reactivity can be measured by means of vascular occlusion test (VOT) using~          non-invasive near infrared spectroscopy (NIRS) to measure tissue Oxygen saturation~          (StO2).~        4. Microvascular reactivity is significantly deranged in patients with early severe sepsis~          and is quantifiably different from non-septic critically ill patients.~        5. Other measures of microcirculatory perfusion ie. sublingual orthogonal polarization~          spectral (OPS) video microscopy, are abnormal and will directionally correlate with VOT~          and StO2 in severe sepsis~        6. In severely septic patients response to therapy can be assessed by VOT and StO2~          monitoring and will correlate with prognosis.~        7. A management protocol incorporating VOT and StO2 monitoring in addition to conventional~          hemodynamic and biochemical parameters as a guide to therapy will result in improved~          outcomes in severely septic patients.~      This project will investigate the use of a non-invasive near infrared light (NIR) device in~     conjunction with brief arm compression to measure the microcirculation in critically ill~     patients. It is know that in patients with overwhelming infections, their blood vessels do~     not respond normally and the NIR device can help measure how abnormal their blood vessels~     are. This type of testing is non-invasive and can be performed repeatedly without harm to the~     patient and may provide an earlier way to determine whether they have overwhelming sepsis and~     also may help to optimize the treatments they receive and better tailor their treatments to~     the degree of blood vessel abnormalities that are found. If our hypotheses are correct, this~     simple non-invasive test could provide a very rapid means of assessing patients that could be~     done more safely and quickly than some of the current methods. This would have an important~     effect to enhance patient safety and improve outcomes in such critically ill patients.~   "
155688|NCT01528345|"~     This trial is designed to enroll postmenopausal patients with locally advanced or metastatic,~     HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy,~     and whose disease has progressed on or after prior endocrine therapy.~      Patients must undergo molecular pre-screening prior to entry.~   "
155689|NCT01528332|"~     The purpose of this study is to determine if the Pain Relief Patch, which shines light of a~     limited wavelength on the painful area of the back, relieves chronic musculoskeletal back~     pain. At the same time, this study will gather information on side effects associated with~     use of the Pain Relief Patch. The study will compare the Pain Relief Patch to a patch that is~     similar in appearance, but which shines a different, presumed nontherapeutic, wavelength of~     light.~   "
155690|NCT01528319|"~     To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation~     of shoulder~   "
155691|NCT01528306|"~     This is a pilot study designed to see if HP802-247, an investigational treatment with living~     human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis~     Bullosa (DEB). The durability of the skin in healed wounds treated with HP802-247 will also~     be assessed.~   "
155692|NCT01528293|"~     This is a prospective, randomized, comparative interventional human subject trial. Patients~     with a chronic venous ulceration of the lower extremity will be enrolled into this study.~     These wounds must be recalcitrant to the standard treatment regimen. There are a total of two~     arms in this study. One group will be randomly assigned to receive Vacuum Assisted Closure~     (V.A.C. or VAC) by means of the ActiV.A.C. + Compression therapy group consisting of the~     application of this device along with compression therapy. The other group will be randomly~     assigned into compression therapy only group. A total of 60 subjects will be enrolled into~     this 6 week study. There will be a 2 week run-in period (prior to the onset of the~     intervention) to ensure that the wound has not healed greater than 35% prior to intervention~     and randomization. Wounds that heal within the 6 week trial period will have an additional~     confirmatory visit 2 weeks after healing was identified.~      If within the 6 week intervention period the wound bed is determined to be ready for a Split~     Thickness Skin Graft (STSG) or Bio-engineered Alternative Tissue (BAT), the surgery or clinic~     application will be scheduled within 4 weeks. Subjects deemed not to be a surgical candidate,~     will have Bio-engineered Alternative Tissue (BAT) application in the clinic. This includes~     patients who are medically unstable to receive a medical clearance for surgery or otherwise~     not a candidate for Split Thickness Skin Graft (STSG) surgery (e.g. donor site skin is~     compromised). During this period between the scheduled STSG surgery or BAT application, the~     subjects will continue within the assigned treatment group. A confirmatory visit will also~     occur 2 weeks after the application of a Split Thickness Skin Graft (STSG) or Bio-engineered~     Alternative Tissue (BAT).~      Patients diagnosed with a chronic venous ulceration will be assessed for study eligibility~     during their initial clinical evaluation. Patients who meet the eligibility requirements will~     be asked to enroll into the study (see Subject Recruitment). Subjects will be asked to sign~     the informed consent form and receive a copy of the informed consent.~   "
155693|NCT01528280|"~     The purpose of this study is to access whether shift workers (morning, afternoon or night)~     vaccinated against hepatitis A would have some humoral and cellular response impairment.~   "
155694|NCT01528267|"~     The prupose of this study is to determine the feasibility, effectiveness, and safety of~     injecting blood into the airways to cause lung volume reduction in people with severe~     emphysema.~   "
155695|NCT01528254|"~     The purpose of this study is to determine whether the initiation of a vildagliptin plus~     metformin combination regimen would result in more durable glycemic control than metformin~     monotherapy in treatment-naïve patients with T2DM.~   "
155696|NCT01528241|"~     This study is designed to characterize the regional distribution of [11C] ABP688 in brain by~     positron emission tomography (PET).~   "
155697|NCT01528228|"~     Following standard of care procedures for arthroscopy knee surgery it is anticipated that~     Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and~     improve functional outcomes.~   "
155698|NCT01528215|"~     The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to~     implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate~     up to five years after implant loading. The hypothesis is that there will be no clinically~     relevant differences in marginal bone level alterations one year after functional loading.~   "
155699|NCT01528202|"~     The aim of this investigation was to examine the effects of tart Montmorency cherry juice on~     urinary 6-sulfatoxymelatonin and sleep quality using a double-blind, placebo-controlled,~     cross-over design.~   "
155700|NCT01528189|"~     Despite improvements in surgical techniques and perioperative care, the high incidence of~     postoperative surgical site infections remains a major problem in patients undergoing major~     abdominal surgery (liver, pancreatic and colorectal surgery).~      Using the hyperinsulinemic-normoglycemic clamp technique, i.e. continuous infusion of insulin~     combined with dextrose titrated to clamp blood glucose between 4 and 6 mmol/L, we~     successfully established and preserved normoglycemia during the perioperative period. Our~     objective of this study is to determine if the maintenance of perioperative normoglycemia by~     a hyperinsulinemic normoglycemic clamp reduces the rates of incisional and space/ surgical~     site infections following abdominal surgery (liver, pancreatic and colorectal surgery).~   "
155701|NCT01528176|"~     To determine whether or not chronic kidney disease (CKD), stages III—V and ESRD , is~     associated with altered vitamin D metabolism related to fibroblast growth factor-23 (FGF-23)~     stimulation of Cyp24 and whether they have resistance to elevations of 25 Hydroxyvitamin D~     (25(OH)D3) after cholecalciferol supplementation.~      To determine if such resistance is related to enhanced catabolism of (25(OH)related to~     elevated levels of FGF-23.~   "
155702|NCT01528163|"~     In this clinical trial, the investigators want to know if cabazitaxel is more effective than~     methotrexate for patients with recurrent or metastatic squamous cell carcinoma of the head~     and neck in palliative treatment.~   "
155708|NCT01528085|"~     The goal of this trial is to evaluate the efficacy and the tolerance of the combination of~     nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy~     in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a~     common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be~     used in this trial with the addition of nilotinib as concomitant therapy during induction,~     consolidation and maintenance. The patients will be prospectively monitored for minimal~     residual disease and bcr-abl tyrosine kinase domain mutations.~   "
155709|NCT01528072|"~     The purpose of this study is to assess the safety and fusion rates following posterior~     lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to~     literature control.~   "
155710|NCT01528059|"~     Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be~     varied by different gastric-small intestine reconstruction used in the procedure. There are~     reports that Roux en Y reconstruction may give a better result. The purpose of this study is~     to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid~     with type 2 diabetes.~   "
155711|NCT01528046|"~     H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator,~     but will not be recruiting locally.~      The purpose of this study is to evaluate the tolerability and safety of escalating doses of~     metformin on a backbone of vincristine, irinotecan and temozolomide (VIT) in children with~     recurrent and refractory solid tumors.~   "
155712|NCT01528033|"~     This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate~     the efficacy of Vacuum Assisted Closure® (V.A.C.®) for the treatment of postsurgical~     abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous~     tissue that permeates the internal organs must be intact.~      Main outcome measure is the time until complete wound closure that sustained for a minimum of~     14 days. Furthermore the therapy options will be examined regarding several other clinical,~     safety, patient reported and economic parameters.~      Patients will be assigned equally and by chance to both treatment groups. Study participants~     as well as the attending doctors and nurses will be informed about the assignment to the~     respective treatment arm.~      The primary outcome measure and some of the secondary parameters like reappearance of the~     wound and the development of the wound size over time, examined within an active study~     treatment time of 42 days, will be photographed and analysed under the use of a central~     computer system. The central analysing personal will not be informed about patient details or~     therapy allocation.~      Patients with at first closed belly wounds with wound healing disorder in the postoperative~     course after surgery without an opening of the underlying layer of fibrous tissue are~     eligible to be included in the trial if the diagnosis of a wound healing impairment in the~     postoperative course is manifested as a wound with spontaneous dehiscence, a wound that~     requires an active reopening of the suture by the treating physician or a wound that cannot~     be closed by primary intention and requires further treatment to achieve permanent closure.~      Study participants will be selected and enrolled within clinical surgical departments which~     provide the respective personal, structural and scientific background for the conduction of~     the trial project.~      Trial therapy will be started in-hospital and may be continued in ambulatory care. It is very~     important to examine the therapy options also in the ambulant care setting thus study~     participants with good health who are able to continue the specific wound treatment in~     ambulant should be transferred to the ambulant service as soon as possible.~   "
155713|NCT01528020|"~     Suicide is the third leading cause of death among adolescents in the US yet there is a~     paucity of research on effective treatments for this population. The primary aim of the~     research described in this application is to evaluate the efficacy of dialectical behavior~     therapy (DBT) for suicidal adolescents. DBT has an empirical track record with suicidal~     adults of reducing the incidence, frequency and medical risk of suicide attempts and~     non-suicidal self-injuries among individuals meeting criteria for borderline personality~     disorder (BPD). While DBT is widely used in the community with suicidal adolescents,~     particularly those with difficulties characteristic of BPD such as poor emotion regulation~     and impulse control, no randomized trial of DBT with suicidal adolescents has ever been~     conducted. And, while non-randomized trials indicate that the intervention is both safe and~     effective, without a randomized trial the investigators simply do not know whether DBT for~     suicidal adolescents is efficacious or not. Given the severity of the problem and the lack of~     alternative treatments for high risk adolescents, addressing this question is of great~     importance. The second aim of the research is to analyze mediators of reduced suicidal and~     self-injurious behaviors in adolescents. 170 adolescents at two sites (Seattle and Los~     Angeles) will be randomized to DBT or Individual and Supportive Group Therapy (IGST). Both~     treatments include 6 months of individual and group treatment and adolescents and a parent~     complete 5 assessments over a 1-year period.~   "
155714|NCT01528007|"~     The aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as~     combined with CBT-intervention in the treatment of pathological gambling (PG). The study~     period is 2011-2014 during which one hundred Pathological Gamblers will be recruited to~     participate to this placebo-controlled double-blind trial.~   "
155715|NCT01527994|"~     Current treatments for opioid addiction would benefit by the addition of a non-opioid based~     treatment medication. Recent behavioral studies have shown that the neurokinin-1 (NK1)~     receptor is involved in opioid reward and withdrawal. This study proposes to study a~     potential non-opioid treatment, the clinically available, FDA approved, NK1 antagonist~     aprepitant, in opioid addicted patients. Based on the unique behavioral and pharmacological~     characteristics of opioid addiction, and what is known of the currently employed treatments,~     the investigators propose that the therapeutic mechanism of any potential opioid addiction~     treatment medication must include the ability to reduce opioid withdrawal. This is of~     particular importance during treatment initiation (eg. detoxification). In addition, for~     long-term treatment and relapse prevention, it is important to manage drug craving and~     inhibit the rewarding effects of opioids if patients do experience a slip. Therefore, the~     investigators propose to study aprepitant using human models of opioid withdrawal, craving~     and acute opioid reward and reinforcement. The investigators will also include a~     neuro-economics choice procedure paradigm.~   "
155716|NCT01527981|"~     This study is a pilot behavioral intervention trial, designed to initially examine cognitive~     behavioral therapy for medical adherence and depression (CBT-AD) in patients with depression~     and poorly controlled type 1 diabetes.~   "
155717|NCT01527968|"~     TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there~     is no literature available comparing the two in total knee arthroplasty (TKA). The~     investigators want to determine if TXA or EACA compared with placebo are effective and safe~     for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.~   "
155718|NCT01527955|"~     The purpose of this study is to determine how effective Kelee meditation is in improving~     stress, anxiety, and depression.~   "
155736|NCT01527721|"~     Primary objective of this study was to assess the impact of the two prevalent therapeutic~     options, CxL and CxL combined with topography-guided photorefractive keratectomy (t-PRK), on~     both anterior and posterior corneal High order aberations (HOAs).~   "
155719|NCT01527942|"~     Bariatric patients usually require the use of either intravenous or oral opioid medications.~     The use of opioids, however, is often associated with side-effects such as nausea, sedation~     pruritus, urinary retention and respiratory depression with often delay patient discharge.~     This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to~     determine if this will decrease the use of opioids post-operatively for pain management in~     morbidly obese patients undergoing laparoscopic bariatric surgery.~   "
155720|NCT01527929|"~     Primary Objective:~      - To assess potential impact of moderate and severe renal impairment on the pharmacokinetics~     of cabazitaxel~      Secondary Objective:~      - To assess the safety of cabazitaxel in patients with various degrees of renal impairment~   "
155721|NCT01527916|"~     This is an efficacy and safety study evaluating a new treatment for subjects with mild to~     moderate Alzheimer's disease.~   "
155722|NCT01527903|"~     The purpose of this study is to compare propofol-remifentanil sedation with~     midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in~     the ICU, as well as the incidence of delirium. Primary end-points were weaning time and~     extubation time, and secondary end-points were the incidence of delirium and length of stay~     in the ICU.~   "
155723|NCT01527890|"~     In this retrospective study, the investigators examined incidence and risk factors of~     postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous~     patient-controlled analgesia (IV-PCA).~   "
155724|NCT01527877|"~     This study is to evaluate disease control rate (DCR) at 8 weeks of BKM120 administered as~     therapy for patient with recurrent/metastatic head and neck squamous cell carcinoma.~   "
155725|NCT01527864|"~     A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out.~     Patients were randomly assigned to the treatment (PC + pegylated endostatin) or the control~     group (PC+ placebo). The efficacy was evaluated every six weeks.Follow-up continued until~     disease progression or death.~   "
155726|NCT01527851|"~     Introduction: Currently, bariatric surgery appears to be the most effective treatment to~     improve the health of morbidly obese population. However, the massive weight loss induced by~     this intervention can create excess loose skin in various parts of the body contributing to~     the feeling of failure in their desire to feel better in some patients. Several studies show~     that people are once again disappointed and dissatisfied with their body appearance due to~     the mass of unsightly loose skin that disrupts their quality of life. However, very few~     studies have focused on the barriers that this excess skin could create in everyday physical~     activity. The aim of the investigators pilot study is to assess the impact of excess skin on~     the practice of physical activity in women who underwent bariatric surgery and evaluate if~     there is a relationship between physical activity and the level and location of excess skin.~     Also, the investigators will explore, the benefits of plastic surgery in patients who had~     this intervention.~      Materials and methods: About twenty women who underwent bariatric surgery and a dozen who had~     subsequent plastic surgery will be included in this pilot study. Anthropometry, weight loss~     post bariatric and plastic surgery, motivational stage on the practice of physical activity,~     usual practice of physical activity, functional and physical ability, perceived benefits and~     barriers of physical activity, self-esteem and quality of life will be assessed. After~     analyzing the results, a group discussion will be established to further evaluate the impact~     of excess skin on the practice of physical activity. The evaluation will be identical for~     monitoring the effects of plastic surgery but the discussion group will also address the~     benefits and satisfaction related to plastic surgery.~      Expected results: Excess skin could be a barrier to physical activity by limiting the~     functional and physical capacity. Thus, plastic surgery could improve the practice of~     physical activity with a direct improvement of functional discomfort, the subjects'~     motivation to be physically active, perceived benefits and barriers to physical activity,~     self-esteem and quality of life.~      Issue project: This pilot project will generate data that will allow us, depending on the~     relevance of the results, to continue the investigators investigation with a larger cohort.~   "
155727|NCT01527838|"~     This trial is a prospective, open-label, single-arm trial of the safety of a single~     FT1050-treated CB unit for hematopoietic reconstitution after a reduced-intensity~     conditioning regimen for hematologic malignancies. A maximum of 40 eligible adult subjects~     will be enrolled and treated in the trial at approximately 2-4 centers within the U.S.~   "
155728|NCT01527825|"~     The overall aim of this project is to evaluate the safety and immunogenicity of 3 different~     dosing options of trivalent influenza vaccine (TIV) vaccination of HIV-infected pregnant~     women: single dose, double dose (at same time point) and two-doses (1 month apart).~   "
155729|NCT01527812|"~     The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound~     guided femoral nerve block using the following endpoints: circumferential spread, anterior or~     posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for~     operative fixation of fractured neck of femur.~   "
155730|NCT01527799|"~     The purpose of this study is to use comprehensive exercise testing to examine causes of~     exercise limitation in children and young adults with sickle cell anemia.~   "
155731|NCT01527786|"~     Postpartum depressed women suffer from functional impairment in their mood, thoughts,~     cognition and physical well being leading to poor motivation, bonding difficulties, decreased~     productivity, conflict and neglect. Moderate/ severe depression responds best to a~     combination of antidepressants and counseling. This study will estimate the proportion of~     women who return to functionality after treatment with Desvenlafaxine and examine the~     differential impact of change in depression and anxiety symptoms on functionality over twelve~     weeks. Depression and anxiety symptoms will be monitored through six mood questionnaires;~     functional recovery will be monitored through a simple self-report questionnaire at each~     visit.~   "
155732|NCT01527773|"~     TOPDOCS is a prospective cohort study including COPD patients from currently six study~     centers in Switzerland. Patients with COPD GOLD stages I-IV will be enrolled and followed-up~     annually for at least 3 years. Yearly assessments will include a detailed patient history,~     quality of life and activity questionnaires, history of exacerbations, lung function,~     measurements of exercise capacity, measurements of vascular function, exhaled breath analysis~     and blood sampling. The overall objective of the project is to establish a meticulously~     characterized cohort of COPD patients living in Switzerland in order to allow high quality~     research on the pathogenesis, treatment and complications of COPD. The specific aim of the~     project is to determine clinically relevant COPD phenotypes and biological factors~     influencing vascular function in COPD patients.~   "
155733|NCT01527760|"~     To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential~     Hypertension by conducting clinical trial in moderate hypertensive patients for a period of~     six weeks.~   "
155734|NCT01527747|"~     The purpose of this study is to test the effects of saxagliptin, a treatment for diabetes, on~     fasting and post-meal blood triglyceride (blood fat) levels.~   "
155735|NCT01527734|"~     The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose~     comparison with a open-label, crossover, formulation comparison.~   "
158573|NCT01490463|"~     The purpose of this study is to determine the incidence and impact of brain lesions in MRI~     after coiling and clipping of unruptured intracranial aneurysms on clinical and neurological~     outcome of patients.~   "
155738|NCT01527695|"~     This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or~     female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a~     clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20~     patients to complete this study.The study will evaluate the effect of 8 weeks treatment with~     AZD3241 on microglia activation as measured via PET examinations.~   "
155739|NCT01527682|"~     Objectives:~      The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a~     selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to~     surgical procedures. Safety will be assessed, too.In the first version of the protocol 96~     eyes were forecasted to complete the enrolment. The protocol was then amended and now to~     complete the study 68 eyes should be included.~   "
155740|NCT01527669|"~     The objective of the study is to evaluate the pharmacokinetics of lovastatin and lovastatin~     acid of four 600 mg LipoCol Forte capsules compared to that of one 20 mg lovastatin Tablet~     after single oral administration in healthy subjects.~   "
155741|NCT01527656|"~     This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence~     of two formulations of biphasic insulin aspart 70 in healthy male subjects.~   "
155742|NCT01527643|"~     This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence~     of two formulations of biphasic insulin aspart 50 in healthy male subjects.~   "
155743|NCT01527630|"~     This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence~     of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.~   "
155744|NCT01527617|"~     The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical~     trial is to investigate the potential antioxidant benefits of a cranberry beverage. The~     investigators hypothesize the chronic consumption of this beverage will improve indices of~     oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators~     also hypothesize that these benefits will be particularly evident following an oral glucose~     tolerance test.~   "
155745|NCT01527604|"~     The objective of this randomized, double-blinded, placebo-controlled, parallel trial is to~     determine whether consuming avenanthramide-enriched oats daily for 8 weeks on can improve~     biomarkers of inflammation in older, obese adults.~   "
155746|NCT01527591|"~     The purpose of this study is to determine the safety and long-term immunogenicity of the~     13-Valent Pneumococcal Conjugate vaccine in children who are solid organ transplant~     recipients.~   "
155747|NCT01527578|"~     The University of California, San Francisco (UCSF) Simons Variation in Individuals Project~     (Simons VIP) is currently recruiting healthy controls for a study aimed at better~     understanding autism spectrum disorder. The UCSF site of the Simons VIP is conducting~     functional and structural imaging, neuropsychological evaluation, genetic testing, and~     neurologic exams in healthy individuals to compare with findings in autism spectrum disorder.~   "
155748|NCT01527565|"~     This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence~     of two formulations of biphasic insulin aspart 70 in healthy male subjects.~   "
155749|NCT01527552|"~     This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence~     of two formulations of biphasic insulin aspart 50 in healthy male subjects.~   "
155750|NCT01527539|"~     This trial is conducted in North America. The aim of this trial is asses the long term safety~     and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes who had~     participated in the BIAsp-1237 trial.~   "
155751|NCT01527526|"~     Objective:~      The purpose of this study is to determine the etiology of the weight increase in~     Depot-medroxyprogesterone Acetate (DMPA) users.~      Method:~      Prospective study with 100 women, aged 18-40 years old and BMI < 30kg/m², paired with users~     of a non hormonal method follow for two years. Will be included only women who never used~     DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of~     corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their~     control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance~     of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with~     ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic~     alterations should elucidate the etiology, and the beginning of the sub clinical~     cardiovascular disease should be shown/discarded with the arterial evaluation.~   "
155752|NCT01527513|"~     To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as~     adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.~   "
155753|NCT01527500|"~     The amendment is designed to test the safety and efficacy of lower and higher doses of~     Intravitreal (IVT) LFG316 using single and 18 successive monthly injections in patients with~     geographic atrophy (GA). The study will also provide information on the safety, tolerability,~     serum concentrations and pharmacodynamics of single and multiple IVT doses of LFG316.~   "
155754|NCT01527487|"~     The investigators propose a randomized phase II study evaluating the pCR and toxicity~     profiles of combination eribulin/cyclophosphamide (ErC) and docetaxel /cyclophosphamide (TC)~     as neoadjuvant therapy for locally advanced HER2-negative breast cancer.~   "
155755|NCT01527474|"~     This will be an 8-week, open-label trial evaluating the efficacy of escitalopram as~     monotherapy in the treatment of patients with postpartum depression (PPD). The acute phase of~     the study will consist of an 8 week treatment phase. Treatment of eligible participants will~     be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the~     presence of depressive symptoms and side effects up to a maximum of 20mg/day.~      Study objectives are:~        1. to investigate the efficacy of escitalopram in the treatment of PPD.~        2. to assess the effects of escitalopram on patients quality of life.~   "
155756|NCT01527461|"~     The purpose of this study is to show that dogs are able to detect cancer in sweat samples.~     This potentially would be the base for developing a new efficient, non invasive and~     inexpensive diagnosis tool of lung cancer.~   "
155810|NCT01526733|"~     The purpose of this study is to evaluate consistency of accelerated insulin absorption and~     onset-of-action and shortened duration of action for bolus insulin infusions after~     pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 [rHuPH20])~     injection at the time of infusion set insertion compared to sham injection.~   "
155757|NCT01527448|"~     This is a 9-week single-centre, open-label, dose-escalating study evaluating the efficacy and~     safety of Quetiapine XR given as monotherapy in the treatment of non-lactating, post-partum~     women diagnosed with Bipolar II Disorder. Subjects will need to visit the study doctor up to~     8 times over a period of 9 weeks.~      During the study period, subjects will be receiving a treatment with Quetiapine XR. The~     starting dose of quetiapine that subjects will receive is 50mg. The response to the treatment~     of quetiapine will determine whether the study doctor will increase the dosage of the~     subject's quetiapine. If the study doctor increases the quetiapine during the study, the~     maximum dosage allowable during the study is 300mg.~   "
155758|NCT01527435|"~     The purpose of this study is to evaluate the fact that 20 milligrams per day of oral~     Zeaxanthin as a supplement to patients with Choroidal neovascularization (CNV) and exudative~     age related macular degeneration (ARMD) undergoing combination therapy with intravitreal~     Bevacizumab (Avastin), intravitreal Dexamethasone and PDT laser photocoagulation and improves~     anatomic and visual outcome compared to patients not receiving oral Zeaxanthin. Study~     patients will be taking AREDS(PreserVision) and multivitamins (Centrum Silver); in addition~     one-half of the patients will receive 20mg of oral Zeaxanthin.~   "
155759|NCT01527422|"~     We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim~     (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer~     the chemotherapy courses every 2 weeks with the practical advantage of requiring only one~     dose of PEG-filgrastim instead of daily doses of G-CSF.~   "
155760|NCT01527409|"~     The Objectives of this study is~        1. To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of~          participating in tailored program (Health Partnership Program) for 24 weeks~        2. To evaluate the efficacy for quality of life, life satisfaction, health leadership,~          anxiety, depression, impact of event, social support, cancer belief as a result of~          participating in tailored program (Health Partnership Program) for 24 weeks~        3. To assess the efficacy of such intervention compared with usual care in cancer patients~   "
155761|NCT01527396|"~     The purpose of this study is to evaluate the efficacy of low risk criteria for lymph node~     metastasis, that was determined by KGOG-2014 retrospective study, in women with endometrial~     cancer.~   "
155762|NCT01527383|"~     This is a randomized, double-blind, placebo-controlled study to assess the safety and~     tolerability of V212 when administered to adults with autoimmune disease.~   "
155763|NCT01527370|"~     This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults~     in India.~   "
155764|NCT01527357|"~     The primary objective of the study is to demonstrate the superiority of Fibrocaps plus~     gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects~     with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery.~      This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial~     that will be conducted at clinical trial sites in the European Union and United States.~   "
155765|NCT01527344|"~     Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in~     transplanted hearts which is a significant cause of morbidity and mortality. The broad~     objective of this research study is to advance our ability to diagnose as early as possible~     the presence of CAV and to non-invasively predict those patients at increased risk of CAV~     with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging~     technique using an optical analog of ultrasound with a resolution 10 times greater resolution~     than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood~     have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial~     tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of~     atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for~     routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, Minnesota (MN) that~     reach inclusion and exclusion criteria for the study will be approached on the day to get~     informed consent to perform OCT, blood sampling and peripheral endothelial function testing.~     The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT~     versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with~     absolute counts of EPCs and 3) with peripheral endothelial function scores.~   "
155766|NCT01527331|"~     The purpose of this study is to compare the decision making of hospitalized subjects with~     advanced cancer having a verbal discussion about CPR compared to subjects using a video.~   "
155767|NCT01527318|"~     Neutral Lipid Storage Disease With Myopath (NLSDM) is a disease caused by a defect in the~     PNPLA2 gene encoding ATGL. Patients with NLSDM accumulate triglycerides and exhibit muscle~     weakness, cardiac failure and hepatosteatosis. Most of these patients die at young age due to~     cardiac failure. Not much is known about the underlying mechanisms, though recently it was~     discovered that PPAR activation in ATGL-/- mice was impaired leading to decreased~     mitochondrial function, lipid accumulation and cardiac failure resulting in death at young~     age. Activation of PPARs, by treatment with fibrates rescued the phenotype and reduced~     mortality rates in these mice. These findings may have a major impact for patients with NLSDM~     if these results can be translated to humans. Therefore, the investigators would like to~     evaluate the beneficial effects of fibrate treatment on muscle mitochondrial and cardiac~     function in patients with NLSDM.~      Patients will be treated with fibrates during a period of 28 weeks. Baseline measurements~     will be performed prior to the study and after treatment. Cardiac and muscular lipid~     accumulation, cardiac function, mitochondrial function and insulin sensitivity will be~     assessed during these baseline measurements.~   "
155768|NCT01527305|"~     The purpose of this study is to evaluate the effectiveness and safety of paliperidone~     palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute~     schizophrenia (that is within past 4 weeks).~   "
155769|NCT01527292|"~     The purpose of this study is to determine pain control rate (Percentage of patients in each~     arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months~     post-treatment.~   "
155770|NCT01527279|"~     The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial~     was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation~     during observation sinus rhythm.~   "
155867|NCT01525992|"~     In this study the investigators aim to evaluate the impact of a community pharmacy-based~     program to educate type 2 diabetic patients about medications, life style and self-care.~   "
155771|NCT01527266|"~     Several studies have reported that carbohydrate (CHO) ingestion can improve performance~     during exercise of short duration (less than 60 min). However, there is no apparent metabolic~     explanation for this observation because endogenous CHO stores should not be a limiting~     factor during short duration exercise. Nonetheless, several groups have attempted to~     investigate CHO administration during short duration exercise with varying results. When CHO~     was administered intravenously, no performance effect was observed despite greater plasma~     glucose availability (5). Therefore, it was suggested that during exercise of short duration,~     exogenous CHO ingestion may exert its ergogenic effect by action through the central nervous~     system, possibly mediated by glucose receptors in the mouth. The latter has been investigated~     using a CHO-mouth rinse, whereby the CHO solution is spat out to remove any influence of the~     gut on exogenous CHO oxidation or performance. Using this rinse, studies have demonstrated~     results both for (5, 16), and against (1, 19) any improvement in short duration exercise~     performance when compared with a placebo. The discrepancy in the findings may be due to~     testing subjects in the fed (1) or fasted-state (5), when liver glycogen stores may be~     compromised. However, no study has tested subjects in both the fasted and fed-state using a~     CHO-mouth rinse. It remains to be determined whether CHO-mouth rinse is only effective at~     improving short duration exercise performance when subjects are in the fasted, compared with~     the fed-state. The investigators will test the hypothesis that CHO-mouth rinse improves~     performance in the fasted-state only compared with a placebo-rinse.~   "
155772|NCT01527253|"~     The study evaluates the effect of a diet combining two different functional concepts on~     markers associated to cardiometabolic risk. The functional concepts are selected on the basis~     of their reported ability to influence the inflammatory tonus. It is hypothesized that the~     medium-term consumption of a diet combining low GI-prebiotic foods may positively influence~     various biomarkers associated with the risk for developing metabolic syndrome and~     cardiometabolic disease. Also, the combination of functional mechanisms are expected to~     result in synergistic effects.~   "
155773|NCT01527240|"~     The main objective of this study is to determine whether a single injection of CsA after~     intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day~     30 ± 15 assessed with Flair MRI.~      Secondary objectives are to determine whether a single injection of CsA after intravenous~     thrombolysis is safe and effective regarding to death and disability.~   "
155774|NCT01527227|"~     The research will examine effects of personal, familial, societal and intergenerational~     characteristics on parentification, the effects of parentification on the quality of life of~     the child and what encourages a better quality of life. This research will include 130~     children between the ages of 10-18 who live with at least one parent who struggles with~     serious mental illness in a comparison to 130 children of the same socio-demographic~     characteristics raised by parents from a non-clinical population. The differences between~     these two populations with regard to parentification, quality of life, social support and~     fairness will also be examined. The parents and the children will fill out questionnaires.~     The research group will be recruited from rehabilitation services, mental health clinics,~     psychiatric hospitals and social welfare departments with sampling method. The comparison~     group will be recruited from schools. This research broadens the knowledge of the causes and~     the repercussions of parentification among children of parents who struggles with serious~     mental illness in comparison with children raised by parents from a non-clinical population.~     Few studies have examined children of the mentally ill in Israel, and there are none which~     examined parentification.~   "
155775|NCT01527214|"~     Background: The primary investigation of lung cancer (LC) is for 85% of the cases conducted~     through General Practice, sadly it tends to take a relatively long time from first time the~     patient is seen by their General Practitioner and until they are diagnosed. LC symptoms are~     common, but usual because of benign diseases. Only 33% of LC patients presenting with alarm~     symptoms. On average a General Practitioner in Denmark sees only one patient with newly~     diagnosed lung cancer a year and the doctor will therefore get the clinical experience that~     when they refer a patient, test often come out negative and they therefore fail to refer and~     delay will increase - with a poorer prognosis as a result. Centrally in the diagnosis is~     conventional chest X-ray, which unfortunately is inefficient in many cases, while CT scanning~     has proven effective even for small tumors.~      Hypothesis and aims: The project has three main hypotheses to be tested 1) the GP's use of~     cancer fast-track and detection of suspected lung cancer can be optimized in relation to~     interpretation of symptoms and subsequent referral practices and radiological investigation.~     2) General Practitioners with special training can change the referral routines and 3) direct~     access to fast CT scanning leads to earlier diagnosis of lung cancer.~      Methods: The first part of the study is a register-based study of lung cancer patients' road~     to diagnosis, based on a database of newly diagnosed cancer patients in a year. Second part~     of the study is a clinical, randomized study of the effect of referral directly to fast chest~     CT scan. Primary endpoint is delay, secondary endpoints are referral pattern (use of~     fast-track packet), primary use of CT and 1-year mortality. Furthermore side effects,~     including patient groups with increased delay.~      The study will contribute new knowledge to the way GP's interpret symptoms, the way they~     refer their patients when they suspect cancer, their use of diagnostic imaging and cancer~     fast-track pathways. It will then provide a unique opportunity to create the necessary~     knowledge about the effects of direct referral to fast CT scan and it might be a decision aid~     whether to open for direct CT scan in General Practice for a group of patients.~   "
155776|NCT01527201|"~     The purpose of this randomized controlled trial is to determine the effectiveness of treating~     cartilage lesions found during knee arthroscopy.~   "
155777|NCT01527188|"~     The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite~     (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score~     during the allergen chamber challenge before and after 6 months of treatment.~   "
155778|NCT01527175|"~     The subclavian vein (SCV) is often the preferred site for central venous access.~     Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC)~     approach have been proved to be useful in children. The investigators compared the success~     rate, number of attempts, time tocatheterization, and complication.~   "
155779|NCT01527162|"~     This project will examine the effect of solid ankle foot orthoses (SAFO) on day to day~     walking activity and life participation of ambulatory children with cerebral palsy. The~     investigators propose that SAFO have not effect on levels of walking and life participation~     versus not wearing the SAFO.~   "
155795|NCT01526928|"~     Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI)~     that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while~     sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK)~     and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or~     recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of~     rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.~   "
155780|NCT01527149|"~     This phase II trial studies how well ofatumumab in combination with cyclophosphamide,~     doxorubicin hydrochloride, vincristine sulfate, and dexamethasone alternating with ofatumumab~     in combination with cytarabine and methotrexate works in treating patients with newly~     diagnosed mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, may~     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,~     such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, dexamethasone,~     cytarabine, and methotrexate, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving ofatumumab together with alternating regimens of combination chemotherapy~     may kill more cancer cells.~   "
155781|NCT01527136|"~     This phase I trial studies the side effects and best dose of entolimod in treating patients~     with locally advanced or metastatic solid tumors that cannot be removed by surgery.~     Biological therapies, such as entolimod, may stimulate the immune system in different ways~     and stop tumor cells from growing.~   "
155782|NCT01527123|"~     This is a Phase 1, single-center, open-label study to evaluate the pharmacokinetics of the~     BPO metabolites benzoic acid and hippuric acid with 7-day repeat application of GSK2585823 in~     subjects with acne vulgaris~   "
155783|NCT01527110|"~     This study will be an open-label, multi-center, single arm study to evaluate the safety and~     efficacy of IV zanamivir 600mg twice daily for 5 days in hospitalized subjects with~     laboratory confirmed influenza infection.~   "
155784|NCT01527097|"~     Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may~     be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and~     involvement of cells of the immune system. Atherosclerosis is frequently treated by statins~     (class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce~     inflammation. Some new evidences also suggest that therapy with statins may improve psoriasis~     skin disease.~      The current study aims are to evaluate whether a strong statin named Atorvastatin can improve~     psoriatic skin disease and functioning of the arteries. The study also aims to evaluate if~     the activity of these two diseases are related to levels of common inflammatory biomarkers~     (substance in blood) and whether Atorvastatin can change their levels.~   "
155785|NCT01527084|"~     1. To determine the appropriate timing of surgical intervention after Percutaneous Catheter~          Drainage (PCD) in infected pancreatic necrosis (IPN).~        2. To see the change in morbidity and mortality after changing the interval of surgery~          after PCD~   "
155786|NCT01527058|"~     This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed~     tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics,~     biodistribution, safety and diagnostic performance of 68Ga-BNOTA-PRGD2 in healthy volunteers~     and lung cancer patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg~     BNOTA-PRGD2) will be intravenously injected into healthy volunteers and lung cancer patients.~     Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood~     pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine~     aminotransferase, albumin, and creatinine, and any adverse events will be collected from the~     volunteers. Adverse events will also be observed in the patients.~   "
155787|NCT01527045|"~     This phase II trial studies how well donor atorvastatin treatment works in preventing severe~     graft-versus-host disease (GVHD) after nonmyeloablative peripheral blood stem cell (PBSC)~     transplant in patients with hematological malignancies. Giving low doses of chemotherapy,~     such as fludarabine phosphate, before a donor PBSC transplantation slows the growth of cancer~     cells and may also prevent the patient's immune system from rejecting the donor's stem cells.~     The donated stem cells may replace the patient's immune cells and help destroy any remaining~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also cause an immune response against the body's normal cells (GVHD). Giving atorvastatin to~     the donor before transplant may prevent severe GVHD.~   "
155788|NCT01527032|"~     High-dose melphalan (MEL) with autologous stem cell transplant (SCT) is an effective therapy~     for systemic AL amyloidosis (AL), but treatment-related mortality (TRM) has historically been~     high. The investigators performed a phase II trial of risk-adapted SCT followed by adjuvant~     dexamethasone (dex) and thalidomide (thal) in an attempt to reduce TRM and improve response~     rates. Patients with newly diagnosed AL involving £2 organ systems were assigned to MEL 100,~     140, or 200 mg/m2 with SCT, based on age, renal function and cardiac involvement. Patients~     with persistent clonal plasma cell disease 3 months post-SCT received 9 months of adjuvant~     thal/dex (or dex if there was a history of deep vein thrombosis or neuropathy). TRM was 4.4%.~     Thirty-one patients began adjuvant therapy, with 16 (52%) completing 9 months of treatment~     and 13 (42%) achieving an improvement in hematological response. By intention-to-treat,~     overall hematological response rate was 71% (36% complete response) with 44% having organ~     responses. With a median follow-up of 31 months, 2-year survival was 84% (95% confidence~     interval: 73%, 94%). Risk-adapted SCT with adjuvant thal/ dex is feasible and results in low~     TRM and high hematological and organ response rates in AL patients.~   "
155789|NCT01527019|"~     This study is to assess if the efficacy of cephalosporin is similar to the efficacy of~     norfloxacin in the acute cystitis treatment.~   "
155790|NCT01527006|"~     This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel~     oral suspension on seizure frequency in pediatric participants maintained on one to three~     stable antiepileptic drugs~   "
155791|NCT01526980|"~     This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control~     of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in~     subjects with type 2 diabetes.~   "
155792|NCT01526967|"~     The purpose of this study is to estimate the incidence and severity of peristomal skin~     lesions and evaluate the progression of the peristomal skin condition at 8-15 days following~     application of the barrier.~   "
155793|NCT01526954|"~     This study is designed to evaluate the safety and efficacy of the device while reducing the~     amount of drainage from surgical wounds following large flap surgical procedures, in this~     case abdominoplasty, as compared to the standard of care (closure techniques). It is~     hypothesized that the use of the Cohera device will facilitate reduction or closure of dead~     space when applied to planar surfaces created during an abdominoplasty procedure.~   "
155798|NCT01526889|"~     This is a multi-center, randomized, active-controlled, open-label study. Approximately 24~     patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring~     systemic immunosuppressive therapy will be enrolled.~      Safety, efficacy, and PK assessments will occur at scheduled visits over a 12-week period.~     Low-molecular-weight non-steroidal immunosuppressive medications are allowed up to the~     baseline day as long as the dose has not changed in the 3 weeks prior to baseline, except for~     corticosteroid doses for which may change.~      Patients responding to treatment will be offered up to 6 months of extended tretment~     Assessments for safety will include laboratory safety tests, ECGs, physical exams, ocular~     exams, vital signs and the monitoring of adverse events.~      Study participation may vary from a minimum of 3 months to a maximum of 9 months~   "
155799|NCT01526876|"~     Patients with acute brain injury are at risk for complications such as increased pressure in~     the brain (intracranial pressure (ICP)), decreased blood flow, bleeding, and brain swelling~     (cerebral edema). Several studies have suggested that high blood pressure is associated with~     a worsening outcome possibly due to an increased rate of continued bleeding or rebleeding, as~     well as increased brain swelling (cerebral edema). High systemic (body) blood pressure (SBP)~     may also increase the risk of ongoing bleeding. Therefore lowering the blood pressure (BP) is~     critical, as continued bleeding occurs most frequently in patients with high BP.~      Clevidipine Butyrate (Cleviprex) is a new medication approved by the FDA for the treatment of~     acute high blood pressure (hypertension). Cleviprex is given through an intravenous line (IV)~     and has the benefit of being faster acting and easier to control adjustments than other drugs~     used to treat high BP. Patients who have an acute brain injury and who have severe high BP~     may benefit from this faster acting medication.~      For this study, eligible patients, 18 yrs of age or older, will have been admitted to the~     Neurocritical care unit within 24 hours after their brain injury, who have high systemic~     (body) SBP. The treating physicians will have already had multimodality brain monitoring~     placed for clinical management of the patient (standard care).~      The investigators will use Cleviprex to lower their SBP and record brain pressure and brain~     blood flow measurements from the multimodality monitoring. Due to the severity of their brain~     injury most of the patients eligible for the study will be unable to provide consent.~     Informed consent will be sought from a surrogate (family member, spouse or close friend)~     according to Columbia University Medical Center guidelines.~      Cleviprex is fast acting and effects are seen in about 90 seconds. The medication will be~     started at a low rate, and if the SBP still needs lowering, the dose increased every 90~     seconds until the maximum FDA approved dose is reached. If the SBP is still high, another~     medication used to treat high blood pressure will be added (Cardene or labetolol).~      Once the SBP is lowered and is stable, the Cleviprex will be continued for 6 hours. As part~     of standard care, patients have their blood pressure monitored continuously. After 6 hours~     the treating physician will make a determination to continue clinical management with~     cleviprex or another antihypertensive medication.~   "
155800|NCT01526863|"~     The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral~     tolerance induction to egg in children allergic to egg as compared to a placebo.~   "
155801|NCT01526850|"~     The primary purpose of the study is to evaluate the safety and efficacy of mesenchymal stem~     cells (MSC) for the treatment of patients who have developed an extensive chronic graft~     versus host disease (with skin and/or liver damage) after HSCs transplantation and do not~     respond to first-line therapy.~      The secondary purpose of the study is to evaluate the effect of mesenchymal stem cells (MSC)~     on one-year survival rate, long-term survival rate, life quality and recurrence of patients~     who have developed an extensive chronic graft versus host disease (with skin and/or liver~     damage) after HSCs transplantation and do not respond to hormone treatment.~   "
155802|NCT01526837|"~     This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into~     the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first~     recurrence.~   "
155803|NCT01526824|"~     In patients who have suffered an ischemic stroke or TIA (mini-stroke), as well as in patients~     who are candidates for neuroendovascular stenting, it is standard of care to treat these~     patients with antiplatelet therapy, or blood-thinners, the most common of which is~     clopidogrel (Plavix) with or without the addition of aspirin. A relatively common problem~     encountered with these patients is non-responsiveness to clopidogrel therapy. A prior study~     in cardiac patients showed that the addition of omega-3 polyunsaturated fatty acids (Lovaza,~     or fish oil) can increase a patient's response to therapy with clopidogrel, but there have~     been no studies in neuro patients. In this study, patients will be divided into one of two~     groups: in the study arm, patients will receive clopidogrel +/- aspirin as well as Lovaza. In~     the control arm, patients will only receive clopidogrel +/- aspirin. Assays will be done to~     measure responsiveness to clopdiogrel on days 0, 12-24 hours after loading dose, day 3-5 if~     still inpatient, and at a follow-up visit 20-30 days after the start of the study. The~     investigators believe that this study will show an increase in platelet aggregation in~     patients receiving both clopidogrel and Lovaza.~   "
155804|NCT01526811|"~     The purpose of this study is to assess the benefits of endovascular repair with Endurant~     Stent Graft System by documenting overall mortality, complications, the rate of conversion to~     open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at~     5 years, in a cohort of patients representative of the population treated under real-life~     conditions of use in France.~   "
155805|NCT01526798|"~     Chronic inflammation in dialysis patients is linked to cardiovascular mortality and clinical~     signs and symptoms, like the impaired response to erythropoiesis-stimulating agents (ESAs).~     This study aims to demonstrate that high cut-off hemodialysis is effective in reducing~     chronic inflammation and thereby improving response to ESAs.~   "
155806|NCT01526785|"~     The objective of this study was to evaluate the efficacy and safety of treatment with 4000~     litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.~   "
155807|NCT01526772|"~     Improvements in imaging technology have allowed for the development of small endoscopes~     (slim scopes) half the size of a typical endoscope. These small endoscopes can be passed~     transnasally into the esophagus and stomach with only local anesthesia to the nasal passage~     without the need for deep sedation. They have been used in the detection of diseases of the~     esophagus and stomach,3,4 but have not been used in the detection of complications in the~     post bariatric population~   "
155808|NCT01526759|"~     Dietary fibre seems to have a relevant role in body weight management. In an acute study the~     investigators found that high viscous-high gelling pectin increased feelings of satiety. The~     objective of this study is to study the effects of 2 weeks of supplementation of high~     gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.~      The investigators do this by measuring the difference in ad libitum energy intake after 15~     days of pectin or 15 days of control supplements. The investigators will further measure~     differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and~     composition of microbiota.~   "
155809|NCT01526746|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of tasimelteon (including its breakdown products) in the blood of individuals with~     severe renal impairment compared to individuals who have normal renal function. The safety~     and tolerability of tasimelteon will also be assessed throughout this study.~   "
155811|NCT01526720|"~     Type 2 diabetes mellitus is a complex disease whose clinical phenotype results from the~     variable combination of genetic and nongenetic factors. The aim of the present study is to~     investigate the network linking phenotypes and genotypes in patients with newly diagnosed~     type 2 diabetes mellitus. In selected cases, in which clinical evidence hints at possible~     monogenic basis of the disease, the genotype and the phenotype of relatives also will be~     assessed to elucidate further the etiology of the disease.~   "
155812|NCT01526707|"~     Approximately 5−10% of people with asthma do not respond to to standard therapy and are~     referred to as having difficult asthma. Evidence shows that this poor response is not always~     related to asthma severity and non−adherence to treatment is recognized as a common~     underlying problem, in 35% of these patients. Recognising non−adherence in the clinic is~     problematic as there is no straightforward objective test to identify it.~      Previous studies have demonstrated up-regulation of FKBP51 gene expression following~     treatment with steroids, making it a potential biomarker of steroid exposure. It is therefore~     also a potential biomarker of non-adherence to inhaled corticosteroid therapy. The~     investigators plan to assess the feasibility of distinguishing non-adherent subjects who are~     by omission steroid naïve from adherent subjects, steroid exposed subjects using FKBP51 gene~     expression in sputum and throat swabs.~      To do this the investigators will obtain throat swab and sputum samples from healthy~     volunteers, steroid naïve asthmatics and adherent asthmatics on high dose ICS to assess if~     FKBP51 gene expression is comparable in each group.~      The investigators will then compare the FKBP51 gene expression response to directly observed~     inhaled steroid therapy in steroid naïve, non-adherent and adherent asthmatics. This will~     identify if the response in gene expression distinguishes steroid exposed (adherent) from~     steroid naïve (non-adherent) patients.~      Identifying non-adherence will benefit patients by enabling appropriate tailored management~     for non-adherence to enhance treatment effectiveness. It will also identify patients with~     therapy resistant asthma who have an unmet need and may benefit from expensive novel~     therapies such as Omalizumab.~   "
155813|NCT01526694|"~     This is a prospective, multicenter phase II trial designed to determine efficacy and safety~     of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in~     patients with multiple myeloma (MM) patients after treatment with lenalidomide and bortezomib~     or which are ineligible to one of these drugs.~   "
155814|NCT01526681|"~     This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the~     uses, response rates, and safety of Avance Nerve Graft in the real life clinical setting.~   "
155815|NCT01526668|"~     The purpose of the study is to investigate the effect of four different follow-up strategies~     on postoperative recovery following vaginal or abdominal hysterectomy for benign conditions.~     Furthermore the investigators aim to examine associations between preoperative thresholds for~     pain (thermal and pressure) and postoperative pain and development of chronic pelvic pain~     after benign hysterectomy.~   "
155816|NCT01526655|"~     The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy~     compared with abdominal hysterectomy in a fast track program gives a faster recovery~     postoperatively, causes less tissue damage and less effects on the immunological system, and~     is health economically cost-effective.~   "
155817|NCT01526642|"~     Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory~     failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed~     to treat acute respiratory failure but little information is available about the benefits of~     home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure~     surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine~     whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory~     failure in COPD patients who survived an episode of acute hypoxemic respiratory failure~     (AHRF) treated by Non-invasive ventilation (NIV).~   "
155818|NCT01526629|"~     With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number~     of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the~     recent years. This has resulted in an increase of the number of follow-up (FU) to be~     performed and a growing workload for centers. Remote FU system such as the Medtronic Carelink~     system allows to check remotely the proper functioning of self evaluating devices and give~     informations of some clinical events.~      The objective of this study is to define which patients with a remote follow-up need~     additional onsite visit and to assess to which extent remote FU can be an alternative to~     onsite visit.~   "
155819|NCT01526616|"~     The investigators examined whether a combined therapy with low-dose spironolactone plus~     metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary~     Syndrome (PCOS) patients.~   "
155820|NCT01526603|"~     This is a standard of care document, outlining the therapy for children with high risk~     neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.~   "
155821|NCT01526590|"~     In the US, pancreas cancer is the fifth leading cause of cancer related deaths. It was~     estimated to have taken 36,800 lives in 2010. Unfortunately, curing pancreatic cancer~     requires surgical removal. Surgical removal of the pancreas is associated with high morbidity~     and mortality, as well as high rates of complications. One way to aid surgeons in removing~     pancreatic tumors is by providing them with a good idea of where the tumor is located and~     what surrounding structures are involved. This currently happens through many different~     modalities of imaging; usually computed tomography (CT) and endoscopic ultrasound. Even with~     these forms of imaging (and sometimes others), surgeons will occasionally open a patient and~     find that the tumor cannot be removed due to its involvement with surrounding structures.~      One way to avoid potentially unnecessary procedures or to help a surgeon navigate this~     delicate procedure would be to provide more detailed information about the tumor. Several of~     the techniques currently used to image the body have rapidly advanced over recent years.~     Typical advancements come through better resolution of the images or contrast to enhance~     desired parts of the images. Ultrasound has not seen such a two pronged advance. Ultrasound~     has seen substantial advances in resolution to enhance picture quality, but contrast has not~     been used clinically to assess pancreatic masses whereas it is for cardiologists to use~     contrast to look at potential defects in the heart.~      The contrast that is used with ultrasound is different from that of CT scans. CT scanners use~     a dye that can be potentially hazardous. This dye can lead to serious kidney damage in some~     patients. Ultrasound contrast, on the other hand, is made of small micro bubbles filled with~     a harmless gas. Because of the way ultrasound works, these micro bubbles reflect the sound~     waves differently than the surrounding tissue and thus provide contrast between normal tissue~     and abnormal tissue. The contrast used in this study, Definity, and is the same contrast used~     by Cardiologists.~      The CE-EUS will be used for research purposes only and will not be used for any clinical~     decision making. The surgeon will be blinded to the results of the research CE-EUS. The~     investigators will compare the research pre-operative contrast enhanced endoscopic~     ultrasounds images with already completed standard-of-care CT scans, the actual pancreatic~     involvement seen in surgery and the pathology reports.~   "
173262|NCT01297192|"~     This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of~     solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.~   "
155822|NCT01526577|"~     This will be a dose block-randomized, double-blind, active and placebo controlled, single and~     multiple dosing, dose-escalation study to evaluate tolerability, safety and~     pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital~     signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and~     serial blood samples and urine collections for pharmacokinetic and pharmacodynamic~     evaluations will be conducted at specified time points.~   "
155823|NCT01526564|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse~     drug reaction, and the primary manifestations are different degree of neuromotor,~     sensorineural and autonomic nervous dysfunction.~   "
155824|NCT01526551|"~     The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus~     (HPV) vaccination program to determine if the combination of increased disease and vaccine~     education coupled with the removal of barriers will positively impact the HPV vaccination~     uptake and completion rates among students.~   "
155825|NCT01526538|"~     This study will test the efficacy of d-cycloserine in enhancing response to learning-based~     treatment for cocaine dependence, specifically contingency management.~   "
155826|NCT01526525|"~     The aim of the present study is the comparison of the efficacy of the perioperative~     application of a multimodal analgesia model to the patients, combing common used analgesics~     via intravenous (IV) route, such as tramadol and ketamine, with or without the~     Electroacupuncture (E/A) technique application and the frequency of side effects accession.~   "
155827|NCT01526512|"~     The purpose of this study is to evaluate the role of low dose metronomic cyclophosphamide and~     capecitabine in pretreated metastatic breast cancer.~   "
155828|NCT01526499|"~     The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition~     to docetaxel in first line therapy in metastatic breast cancer.~   "
155829|NCT01526486|"~     Patients with melanoma, some other rare skin cancers, and some cancers of the penis and~     scrotum can have their cancer spread to the lymph nodes in the upper part of the leg, called~     the groin. Medically, this area is called the inguinal area. At present, for melanomas and~     skin cancers this type of spread is usually found with a special test called a sentinel~     lymph node biopsy. This procedure can find spread of even a few cells in a single lymph~     node—allowing the treating doctor to find the spread very early.~      Treatment for patients with skin cancer in the lymph nodes in this area is to remove all of~     the lymph nodes in this area. In patients with cancers of the penis and scrotum who do hot~     have any evidence of cancer having spread either by physical examination or by radiology~     tests, the lymph nodes in this area are removed to check and see if there is cancer in them.~     This is called staging.~      At present, the standard way to remove all of the lymph nodes in the groin is by a large~     incision, approximately 8-10 inches in length. For patients who have this operation, there is~     a very high incidence of infection after surgery: as many as 50% as patients can have a~     problem after surgery. These infections range from a low grade skin infection needing oral~     antibiotics to deep infections requiring the wound to be opened and occasionally needing~     readmission to the hospital and antibiotics given via the vein.~      With the advent of new technology and new equipment, the ability to perform this procedure~     through small incisions away from the groin and further down the leg has become possible.~     This procedure has never been performed routinely nor compared side by side to the standard~     open approach. The investigators propose to perform this protocol in two phases.~      The investigators have performed procedures in 20 groins to this point and have confirmed the~     number of lymph nodes and visually verified that the procedure is identical to the open~     procedure. The investigators performed these procedures in order to insure that the~     investigators were offering an equivalent option regardless of which procedure the patient is~     randomized to.~      The study will involve the randomization of patients undergoing the procedure. The~     investigators will randomize the next 110 patients in a 2:1 fashion (two people will get the~     videoscopic procedure for every one who gets the open procedure) until 73 patients are~     included in the video arm and 37 in the open arm. Outcomes including recurrence rate,~     duration of drain requirements, and incidence of lymphedema will be followed. Patients will~     be followed using standard of care processes, including regular office visits, physical~     exams, and radiographic imaging, when indicated. Patients will be followed for 5 years.~   "
155830|NCT01526473|"~     HER2 is a protein that is over expressed in 20-30% of breast cancers. It is also found~     associated with lung, gastric, ovarian, and pancreatic cancers. Although there are existing~     therapies that can target HER2, most patients will eventually experience progression of their~     disease even though their cancer continues to express HER2. Therefore, new approaches are~     needed for treating tumors that express HER2.~      This clinical trial will use an investigational cancer vaccine called HER2 VRP or AVX901. The~     vaccine is based on a virus called Venezuelan equine encephalitis but it has been changed so~     it cannot cause active infection. Instead, the virus has been changed so it tells the immune~     system to attack cancer cells which make HER2.~      The objectives of the study are to evaluate the safety of immunization with HER2 VRP in~     patients with advanced or metastatic malignancies that express HER2, and to test whether~     immunization will causes a strong immune system attack against the cancer.~   "
155831|NCT01526460|"~     The purpose of this study is to evaluate the effect of a loading dose of two different~     statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which~     is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and~     clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for~     coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.~   "
155832|NCT01526447|"~     The purpose of this randomized controlled trial is to determinate the efficacy and safety of~     Craniosacral Therapy in the treatment of chronic unspecific neck pain.~   "
155833|NCT01526434|"~     The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical~     function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in~     Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis~     Factor alpha (TNFα) Certolizumab Pegol (CZP).~   "
155834|NCT01526421|"~     Highly active antiretroviral therapy (HAART), the current standard of care for treatment of~     HIV infection, is highly effective when taken appropriately. Before starting this treatment,~     a person must be aware of their HIV status and present to a clinic for medical care. They~     then undergo screening procedures (medical assessment and laboratory tests) to determine~     whether they are eligible to receive HAART, i.e. whether HIV treatment is necessary and safe~     for them.~      In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV~     infection among users of illicit drugs. However, HIV-infected drug users often do not present~     to the medical system and complete the process necessary to start HAART. Given the known~     benefits of HAART, new strategies are required to increase rates of HAART initiation in this~     group. Contingency management (CM) is a strategy to affect behaviour by providing a reward~     (e.g. money) to reinforce the desired behaviour. CM has been used with success in other areas~     of medicine (e.g. smoking cessation, weight loss) and in the drug using population, but has~     not been established as a means to improve HAART uptake.~      The proposed research primarily seeks to assess the effectiveness of monetary-based CM in~     engaging HIV-infected drug users in HAART programs. Drug users identified through outreach~     will be randomized in a 1:1 ratio to one of two arms; participants in one arm will be offered~     a monetary-based reinforcer to participate (n=150) and participants in the second arm will be~     offered no reinforcer (n=150). Participation involves reporting to the study site for formal~     study of eligibility screening, consisting of clinical evaluation, medical history and~     laboratory testing required to determine eligibility to receive HAART. Participants~     randomized to the reinforcer arm will receive gift cards at the completion of screening~     procedures.~      Our hypothesis is that drug users offered a monetary-based reinforcer will be significantly~     more likely to complete HAART eligibility screening than those not offered a reinforcer.~   "
173263|NCT01297179|"~     The objective of this study is to determine the effect of multiple doses of mirabegron on the~     pharmacokinetics of an oral contraceptive.~   "
155835|NCT01526408|"~     The specific aim of this study is to determine the efficacy of treatment with famciclovir in~     unilateral Meniere's Disease patients, specifically whether hearing can be improved. The~     investigators will determine the percentage of unilateral Meniere's Disease patients~     experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir~     as compared to the placebo arm.~   "
155836|NCT01526395|"~     In developing countries, electroconvulsive therapy (ECT) is typically delivered without the~     use of an anesthetic prior to the treatment, known as unmodified ECT. This interventional~     study aims to decrease the practice of unmodified ECT at Chhatrapati Shahuji Maharaj Medical~     University, U.P. & G.M. & Associated Hospitals (C.S.M) by administering a low dose anesthetic~     (propofol) prior to ECT delivery. In so doing, the investigators hope to facilitate the~     transition from unmodified to modified ECT without incurring excessive costs to the center.~     It is hypothesized that ECT patients will opt for modified treatment, that adverse effects~     will be minimal, and that costs will not rise prohibitively.~   "
155837|NCT01526382|"~     PiCCO has been widely used in critical care settings for several decades. Together with~     pulmonary artery catheter, it is regarded as the important tool for guiding fluid management~     in patients with shock or acute respiratory distress syndrome. However, its effects on~     patients' outcome remain untested. The investigators study is a pilot study that is designed~     to test whether the use of PiCCO will improve patients' outcome, as compared to those without~     PiCCO monitoring.~   "
155838|NCT01526369|"~     The proposed phase III randomised trial will compare the efficacy of trastuzumab and~     paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2~     positive metastatic breast cancer. The investigators will also examine potential predictive~     biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum~     samples.~   "
155839|NCT01526356|"~     The study is a multi-center prospective, randomized, double-blind, placebo-controlled~     evaluation of the safety and efficacy of a topically applied formulation of rapamycin to~     cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will~     apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to~     their angiofibromas for six months.~      The primary goal of this study is to evaluate the efficacy of the topical medication for~     reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study~     is to confirm the safety of the topical medication.~   "
155840|NCT01526343|"~     While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years,~     virtually all of the historical series reported only the recurrence of symptomatic AF and~     have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use of~     traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the~     Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative~     arrhythmia burden following surgical treatment for AF in patients undergoing either lone or~     concomitant heart surgery.~   "
155841|NCT01526330|"~     The objective of this study is to assess the safety and tolerability of YH14618 during 24~     weeks of follow-up period after single administration in patients with degenerative disc~     disease.~   "
155842|NCT01526317|"~     This clinical trial is designed to compare the pharmacokinetic characteristics of combination~     and separate administration of Crestor(Rosuvastatin) and Glucodown(Metformin SR). Also~     investigate drug interaction between separate and combination administration.~      Total number of subjects is 36. 6 group(6 for 1 group), 3 period, consecutive 5 day~     administration, 10 days washout after 5th day of administration.~      All subjects take Crestor alone, Glucodown alone, Crestor+Glucodown combination during 3 each~     period.~   "
155843|NCT01526304|"~     Kidney stones are very common in industrialized countries and the lifetime risk is about 10~     to 15% in this population. Kidney stones are composed of inorganic and organic components.~     Calcium containing stones are the most common stone type accounting for more than 80% of~     kidney stones. Many factors predispose or contribute to the development of kidney stones,~     including genetic variants or mutations, diet, environmental factors, and behavior. To date,~     little is known on fibroblast growth factor (FGF23) levels in patients with calcium~     nephrolithiasis. FGF23 is crucial for phosphate homeostasis including physiological and~     pathophysiological conditions such as X-linked hypophosphatemic rickets and it seems that~     FGF23 is probably the most important regulator of serum phosphate and calcitriol~     (1,25(OH)2D3) levels in addition to parathyroid hormone (PTH) produced by the parathyroid~     gland. Novel factors such as Klotho and Sclerostin, which are involved in the~     bone-kidney-parathyroid endocrine axis, have been identified recently. Klotho is a putative~     aging suppressor gene and its deficiency results in osteopenia, hyperphosphaturia, and~     calcification. Klotho is mainly expressed in the kidney but also in the parathyroid gland and~     acts as a FGF23 specific co-receptor mediating FGF23 participation in the~     bone-kidney-parathyroid endocrine axis as described above. Sclerostin is a protein secreted~     by osteocytes that inhibits bone formation by osteoblasts. However, the potential role of~     FGF23, Klotho, and Sclerostin in nephrolithiasis is still poorly under-stood or even~     unexplored. The aim of this study is to test if levels of FGF23, Klotho, and Sclerostin are~     differentially regulated in kidney stone formers.~   "
155844|NCT01526291|"~     This study evaluates a questionnaire designed to measure satisfaction and ophthalmic-related~     quality of life (QOL)in up to 550 active duty subjects prior to and six months following~     state-of-the-art laser in situ keratomileusis (LASIK).~   "
155845|NCT01526278|"~     This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy~     postmenopausal women~   "
155846|NCT01526265|"~     Using the NIH-funded Way to Health platform, the investigators will conduct this smoking~     cessation randomized controlled trial (RCT) among CVS employees. The investigators will be~     able to determine the comparative and absolute efficacy and effectiveness of 4 different~     incentive structures that are each grounded in behavioral economic principles. Additionally,~     the investigators will measure rates of and reasons for acceptance of each incentive~     structure, and examine participant characteristics that modify the efficacy and acceptance of~     different incentive structures.~   "
155868|NCT01525979|"~     This proposed project aims to~        -  compare the effects of dose-matched unilateral vs bilateral vs unilateral combined with~          bilateral upper limb rehabilitation based on task-related practice~        -  compare the effects of unilateral vs bilateral training based on robot-assisted devices~        -  study the predictors of treatment outcomes and clinimetric properties of the~          biomechanical measures~   "
155847|NCT01526252|"~     The SCAR study uses a software program entitled QLAB, a proprietory program, developed by~     Philips Healthcare (Philips Healthcare, Andover, MA). Literature on two-dimensional speckle~     tracking imaging (2DSTE) is growing, but data relevant to the population in the SCAR study is~     minimal. Accumulation of data relevant for a population of subjects will provide a set of~     normal values for interpretation of 2DSTE and minimize any influences from differences in~     data produced from different companies. This data may also assist other researchers~     investigate other cardiac diseases and abnormalities.~   "
155848|NCT01526239|"~     Colorectal cancer is the third most common cancer diagnosed and third leading cause of~     cancer-related deaths in the United States for both men and women. The American Cancer~     Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of~     rectal cancer will be diagnosed, and about 49,960 deaths will occur as a result of this~     devastating disease in 2008. Over the last 20 years, the death rate for this cancer has been~     dropping as a result of screening and early detection of cancer. In 2007, ACS reported that~     early-stage colorectal cancer had a survival rate close to 80%, and up to 9,632 deaths could~     be prevented each year if eligible patients received screening when necessary. However,~     despite the proven efficacy of colorectal cancer (CRC) screening, only about 50% of eligible~     US patients are currently being screened.~      Specific Aims~      The central hypothesis of this proposal is that patient-initiated prompting of primary care~     physicians of the patient's interest in screening will increase referrals for CRC screening.~     The following three areas will be investigated during this research:~        1. To determine whether a communication tool provided to patients will initiate a~          conversation with their primary care physicians about CRC screening, especially via~          colonoscopy.~        2. To determine whether this tool will impact referral patterns for screening, especially,~          although not primarily, among poor and underserved populations.~        3. To determine whether differences exist in regard to patient-physician communication~          patterns about screening among residents and faculties in the fields of internal~          medicine and family practice clinics.~      At the close of the investigators study, the investigators wish to organize quantifiable data~     demonstrating how patient-initiated prompting of primary care physicians for CRC screening~     increases early detection and decreases potential mortality from colorectal cancer. This data~     will inform a second, larger study to pursue the questions surrounding patient-initiated~     prompting in~   "
155849|NCT01526226|"~     Preterm children are at increased risk for developing lung disease due to immature lungs.~     Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous~     positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal~     cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased~     pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short~     binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With~     HFNC oxygen/air is administered via two small, thin cannulas located just inside the~     nostrils, but the nostrils are not blocked.~      The aim of this study is to compare patient comfort in premature infants treated with nCPAP~     and HFNC. The investigators hypothesis is that HFNC increases patient comfort.~      The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion~     should be born before 34 weeks of gestation and have moderate respiratory distress, thus be~     in need of nCPAP. During the study period (48 hours) the investigators will consider how~     the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort~     assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress~     hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The~     child's breathing pattern will be carefully monitored. The study involves no extra painful~     investigations.~      The investigators plan to recruit 20 patients.~   "
155850|NCT01526213|"~     Purpose: Grapefruit juice is one of the most extensively studied dietary/natural substances~     shown to interact with a variety of medications. However, unanswered questions remain~     regarding the causative ingredients and mechanisms underlying such drug-grapefruit juice~     interactions. Compounds in grapefruit juice called furanocoumarins have been established as~     major causative ingredients, which act by inhibiting the elimination (metabolism) of drugs,~     leading to increased circulating drug concentrations. Increased drug concentrations can in~     turn lead to increased drug potency or even toxicity. Grapefruit juice also has been shown,~     paradoxically, to decrease circulating concentrations of some drugs, including the~     non-sedating antihistamine agent, fexofenadine (Allegra), which undergoes negligible~     metabolism. Whether or not furanocoumarins mediate the decrease in fexofenadine~     concentrations is unknown. The purpose of the proposed study is to compare the effects of a~     furanocoumarin-free grapefruit juice with grapefruit juice on circulating concentrations of~     fexofenadine.~   "
155851|NCT01526200|"~     Contrast-enhanced intraoperative ultrasound (CE-IOUS) during surgery for colorectal liver~     metastases (CLM) has become a part of clinical practice. However, if it should be selectively~     or routinely applied remains unclear. This study is carried out to clarify which are the~     criteria for a selective use of CE-IOUS if any.~   "
155852|NCT01526187|"~     The purpose of this study is to Measure the fecal carriage of multidrug-resistant bacteria~     after a travel in the tropics.~   "
155853|NCT01526174|"~     The investigators plan to conduct an open-label intratympanic injection proof-of-concept~     trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients~     with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm~     approach. First, the investigators propose to dose 3 individual subjects with a single~     intratympanic injection of golimumab and follow each for 30 days, closely examining them for~     adverse events. If there are no serious adverse events, with FDA approval, the investigators~     propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.~   "
155854|NCT01526161|"~     Asthma affects 1 in 8 children in the UK. Up to half of these are treated with preventative~     medicine in the form of low-dose steroids using an inhaler. The National Asthma Treatment~     Guidelines recommend when this treatment is not working other treatments are started. Studies~     to support this have taken place in adults but not with children. If patients are instructed~     how to use inhalers and are given information about asthma, they can control their disease~     much better. The first part of this study, lasting 4 weeks, will make sure the children and~     their families understand how to use their inhaler. All children will be given the same~     steroid inhaler to use and after 4 weeks those still with symptoms will enter the study~     proper which lasts for 48 weeks. During this part of the study the children will be given one~     of three treatments. These are:- a steroid inhaler + a dummy tablet, an inhaler containing a~     steroid and a long-acting reliever + a dummy tablet or a steroid inhaler + an active tablet.~     In this way the patient, the family and the researchers will not know which of the three~     treatments the child is taking until the code is broken at the end of the study.~      What matters to children is how they feel, are they able to run around and play with friends~     and are they well enough to go to school. The investigators will assess which of the above~     treatments best allow these to happen by asking the parents and children to fill in~     questionnaires on 4 occasions during the study. The investigators will also see which~     treatment best prevents the need for short courses of steroids tablets during the study.~     These are commonly given when asthma symptoms worsen.~      Most children will be started in the study through their general practitioner clinic. It will~     take one year to enroll all 900 children. Once enrolled the children will be followed-up in~     hospital centres. Much of the funding will be required to recruit and follow-up the children,~     train everyone to the same standard and develop and administer the questionnaires and health~     economic assessments. Asthma care is an expensive. The investigators will look at the costs~     and assess which treatment offers most benefit. The team has experience and ability in this~     field and will ensure the results are well publicised. Any child can withdraw from the study~     at any time.~   "
191555|NCT01057030|"~     The purpose of this study is to assess the safety and tolerability of multiple oral daily~     doses of BMS-708163 in healthy young male subjects~   "
155855|NCT01526148|"~     This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness~     trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who~     currently require a medication change for their illness. Stratified randomization will reduce~     bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment~     goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is~     the difference between lithium and quetiapine in the time to 'all cause' medication~     discontinuation.~   "
155856|NCT01526135|"~     This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with~     gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in~     patients with resected pancreatic adenocarcinoma.~   "
155857|NCT01526122|"~     The purpose of this study is to compare characteristics and safety after oral administration~     of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets & Aspirin 100mg 2~     capsules coadministration in healthy male volunteers.~   "
155858|NCT01526109|"~     Quality of Life (Qol) is a complex concept which relates to the perception of subjective~     satisfaction, especially in elderly population. It also relates to the self-perception of~     psychological status, independence level, to the social relationships, and to the environment~     where the elderly person lives. Consequently, there are a number of factors which may change~     the perception of QoL, namely the occurrence of diseases, physical impairment or incapacity,~     and the rupture of social relationship, as well as the aging process itself. Physical~     exercise is associated to improvement of mental and physical health. However, few studies~     investigated the effect of strength training and whole- body vibration training on elderly~     subjects. Following this line of reasoning, the purpose of the present study is to assess the~     effect of physical exercise on cognition and functional abilities in elderly subjects.~     Design: Randomized controlled trial, double-blinded, with 12-week follow-up. Setting: Gama~     Filho University. Participants: Healthy Elderly. Interventions: The patients will be randomly~     assigned to a strength training group (STG), whole-body vibration training group (WBVG) and a~     control group (CG). Main outcome measures: Cognitive function will be assessed using Mini~     Metal State Examination (MMSE), Trail A and B, Digit Span, Stroop Test, Rey auditory-verbal~     learning test and Clock Test, and functional capacity will be evaluated using Senior Fitness~     Test, American Alliance for Health, Physical Education, Recreation & Dance(AAHPERD)functional~     fitness test, and Short Form 36(SF-36) health survey.~   "
155859|NCT01526096|"~     The purpose of this study is to test whether regulatory T-cell reduction is possible and safe~     in myeloma subjects undergoing autologous stem cell transplantation (ASCT).~   "
155860|NCT01526083|"~     The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid)~     on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy~     male volunteers.~   "
155861|NCT01526070|"~     Over the last several years, the standard of care for wet macular degeneration has become~     treatment with intravitreal injections of ranibizumab (Lucentis, Genentech), administered as~     frequently as every 4 weeks. In contrast, clinical trials of a soluble VEGF receptor,~     Aflibercept/VEGF Trap-Eye (Eylea, Regeneron Pharmaceuticals) have demonstrated maintained~     anatomic and visual improvement with many fewer injections (typically monthly injections for~     3 months, followed by every-other-month injections, and as few as 5 injections a year). The~     purpose of this study is to determine whether patients who have switched from ranibizumab to~     VEGF Trap-Eye have comparable results.~   "
155862|NCT01526057|"~     In this study, patients with moderate to severe rheumatoid arthritis who are being treated~     with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan~     (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs~     will be assessed by sampling the levels of drug in the blood, blood cell counts, and by~     comparing these levels among the different treatments. Safety, tolerability and immunologic~     response also will be evaluated throughout.~   "
155863|NCT01526044|"~     The purpose of this study is to evaluate the accuracy and reliability of the continuous~     glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill~     patients by comparing subcutaneous measuring with the current standard of arterial measuring~     by a point of care glucometer.~   "
155864|NCT01526031|"~     The purpose of this study is to evaluate the effectiveness of combined bee venom acupuncture~     (BVA) and physiotherapy (PT) on frozen shoulder, and whether if the effect of BVA is dose~     effective.~   "
155865|NCT01526018|"~     The purpose of this study is to pilot test whether a novel infant feeding bottle changes how~     much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided~     in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided~     with the novel feeding bottle and caregivers will be asked to acclimate their infant to this~     bottle during the next several weeks. Once acclimated, infants will undergo two weighed,~     timed, and videotaped test meals on two separate days; one with the novel bottle and one with~     their standard bottle, in random order. It is hypothesized that when the novel bottle is~     used, infants bottle will consume smaller meals and will have a longer meal duration, as~     compared to when a standard bottle is used.~   "
155866|NCT01526005|"~     Even though the health risks and societal costs of cigarette smoking are well-known, roughly~     19.8% of American adults continue to smoke. While most smokers endorse a desire to quit, very~     few (< 5%) will actually quit in a given year without treatment, and only about 20-25%~     achieve abstinence after 6 months or more of effective treatment. Therefore, there continues~     to be a vital need to improve outcomes for cigarette smokers seeking treatment. Current~     first-line medications for Tobacco Dependence include nicotine replacement therapies (such as~     the patch, gum, lozenge, nasal spray, and inhaler), varenicline HCl (Chantix), and bupropion~     HCl (Zyban), with the current standard of care in most treatment settings being to choose~     specific medications based primarily on availability, ease of use, and patient preference.~     The goal of the proposed research is to improve the delivery of smoking cessation treatment~     by determining if pre-treatment nicotine receptor density in cigarette smokers is associated~     with smoking cessation outcome with the standard nicotine patch taper. The study's main~     hypothesis is that cigarette smokers with less pre-treatment upregulation of nicotine~     receptors will have a greater likelihood of quitting smoking from a standard course of~     nicotine patch treatment than smokers with more up-regulation of these receptors. Positron~     emission tomography (PET) will be used to test this hypothesis.~   "
155869|NCT01525966|"~     This phase II trial studies how well giving carboplatin and paclitaxel albumin-stabilized~     nanoparticle formulation together before surgery works in treating patients with locally~     advanced or inflammatory triple negative breast cancer. Drugs used in chemotherapy, such as~     carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount~     of normal tissue that needs to be removed.~   "
155870|NCT01525953|"~     The aim of this study is to identify prognostic factors for outcome in patients being~     complete clinical responders with chemoradiation or radiation for esophageal cancer~   "
155871|NCT01525940|"~     Colorectal cancer (CRC) is the second most common cause of cancer-related death in the~     Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary~     CRC screening tool in many countries. As a preventative procedure, its main purpose is to~     enable the early diagnosis of CRC at a curable stage and to identify and remove pre-malignant~     adenomas. Cecal intubation is associated with an increased detection rate of advanced~     neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. Complete colonic~     evaluation is therefore a well-recognized measure of colonoscopy quality control. Cecal~     intubation rates of ≥ 90% of all colonoscopies in routine clinical practice and ≥ 95% in~     screening colonoscopies are recommended. Unfortunately, the cecal intubation rate in daily~     clinical practice is often lower than the target of ≥ 90%, with reported percentages varying~     from 76.9% to 98.4%. This means that after an incomplete colonoscopy, malignant and~     pre-malignant lesions may be missed if further investigation is not pursued. Several~     explanatory factors for incomplete colonoscopy have been described. After an incomplete~     conventional colonoscopy, patients are required to undergo another test to complete the~     visualization of the colon. Options for incomplete examinations because of anatomic reasons~     include both radiologic and endoscopic means.~      CT Colonography (CTC ) permits to visualise the whole colon, is minimally invasive, does not~     require sedation and is well accepted by the patient.~      The PillCam Colon Capsule Endoscopy (Given® Diagnostic System)offers an alternative approach~     for endoscopic visualization of the colon in patients with an incomplete conventional~     colonoscopy. Advantages of the PillCam Colon Capsule Endoscopy (PCCE) include the elimination~     of the need for sedation, the minimally invasive, painless nature of the exam, no need of~     X-rays and the ability to pursue normal daily activities immediately following the procedure.~     This is a study that is designed to evaluate the performance of the PCCE in the evaluation of~     patients with an incomplete colonoscopy, compared to the CT-colonography. PCCE and~     CT-colonography procedures will be compared in regards to completeness of the procedure and~     detection of lesions in the colon that would have been missed by the incomplete conventional~     colonoscopy.~   "
155872|NCT01525927|"~     This study looks at the use of three cycles of chemotherapy given prior to radiation therapy~     in patients with cancer of the oral cavity and evidence of prior exposure to Human Papilloma~     Virus (HPV). Patients with cancer of the oral cavity who have evidence of exposure to HPV~     have a better prognosis than those who do not have such evidence of exposure to HPV. The main~     hypothesis of this study is that using three cycles of chemotherapy prior to embarking on~     radiation therapy will allow the use of reduced doses of radiation therapy and, therefore,~     less radiation induced side-effects. The primary objective is to determine the activity of~     this pre-radiation chemotherapy strategy along with reduced dose levels of radiation with or~     without chemotherapy during the radiation phase. The effectiveness of the strategy will be~     assessed at three months following the completion of the radiation therapy phase and also at~     two years following completion of the radiation therapy.~   "
155873|NCT01525914|"~     Hypothesis: That, in men on surveillance for favorable risk prostate cancer treated with~     dutasteride, prostate specific antigen (PSA) kinetics is of value in identifying those men~     who harbor occult high grade prostate cancer.~      The study will determine the prevalence of a secondary rise in PSA > 0.5 ng/ml and the PSA~     doubling time in subjects on surveillance being treated with dutasteride.~   "
155874|NCT01525901|"~     The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1)~     treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene~     deficiency in order to evaluate safety, tolerability, and efficacy. IGF-1 is an injection~     under the skin that contains human IGF-1. IGF-1 is approved by the FDA under the brand name~     Increlex for the treatment of children with short stature due to primary IGF-1 deficiency. It~     is being used off-label in the current study and is not FDA approved, nor has it yet been~     studied in humans for the treatment of SHANK3 deficiency.~   "
155875|NCT01525888|"~     The aim of the current study is to evaluate prospectively whether concomitant administration~     of renin-angiotensin-aldosterone system (RAAS) blockers (namely ACE-I and ARBs') influence~     the change in estimated glomerular filtration rate or GFR (eGFR) after administration of~     contrast media in patients undergoing non-emergent coronary angiography.~   "
155876|NCT01525875|"~     The purpose of this study is to evaluate the effectiveness of magnesium oxide supplements on~     the reversal of calcium deposits in the skin, and the yellow bumps and folds of skin in~     subjects with pseudoxanthoma elasticum (PXE). Magnesium oxide is a dietary supplement that~     has been shown in some research to reduce these calcium deposits. This study consists of two~     parts. The first part is a year-long, double-blind, placebo-controlled study. Part two is an~     open-label, year-long study. In Part 1, qualified subjects will be randomized to receive~     either magnesium oxide supplements or placebo, in a 1:1 ratio for the first 12 months. The~     starting dose will be 1000 mg daily, and depending on tolerability, doses may be decreased.~     Baseline evaluations will be comprised of: blood tests; clinical evaluations; skin biopsy;~     eye examination; bone density test; and photography of skin lesions. Subjects will be~     evaluated at week 2, week 6, month 3, and then every 3 months during the first year. Upon~     completion of the first year, barring any safety concerns, all subjects will be administered~     magnesium oxide supplements for up to one additional year. Subjects will undergo the same~     evaluations/ procedures every 3 months. We hypothesize that the magnesium oxide will cause a~     reduction in calcifications in the subject's soft tissue/skin. Funding Source - FDA OOPD.~   "
155877|NCT01525862|"~     This is a study looking at transnasal sinus balloon dilation without tissue removal treating~     the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic~     improvement post-procedure.~   "
155878|NCT01525849|"~     The objective of this study is to show that long-term symptom improvement after sinus balloon~     dilation is not worse than symptom improvement after functional endoscopic sinus surgery~     (FESS) and that fewer postoperative debridements are required after balloon dilation than~     after FESS.~   "
155879|NCT01525836|"~     The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known~     hospitals in China. In order to report the efficacy and safety of Recombinant Human~     thrombopoietin combining with Rituximab for the treatment of adults with refractory immune~     thrombocytopenia (ITP), compared to conventional Rituximab therapy.~   "
155880|NCT01525823|"~     The purpose of this study is to assess the effects of Metformin administered over two weeks~     on the peak plasma glucose concentrations following administration of BMS-754807.~   "
155883|NCT01525784|"~     The incidence of Type 1 Diabetes Mellitus is increasing annually, in all pediatric age~     groups, especially among infants and toddlers.However, only 30% of diabetic children manage~     to achieve and maintain glycated hemoglobin A1c (HbA1c) levels below 8%, although most are~     treated by intensive insulin therapy.Recently, devices for real-time continuous glucose~     monitoring (RT-CGMS) have been introduced to aid self management of glycemic control. These~     devices enable the patients to see the interstitial glucose levels continuously, the trends~     of decrement and increment, and to have alarms prior to a severe hypoglycemic episode .~      The RT-CGMS was approved in Israel for routine usage in the pediatric population, 0-18 years~     in 2011, indicated for those with recurrent hypoglycemic episodes. So, the aim of the~     investigators study is to examine prospectively the short and long term effect of the RT-CGMS~     routine usage, in daily routine life of the diabetic child.~   "
155884|NCT01525771|"~     A maximum of 8 cycles of chemotherapy will be administered. Depending on patients'~     tolerability, 8 cycles of chemotherapy will be given to the patients.~   "
155885|NCT01525758|"~     The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with~     knee osteoarthritis by orally administration and to determine optimal dose.~   "
155886|NCT01525745|"~     The purpose of this study is to determine how effective SBRT is compared to traditional~     radiation in treating the cancer that has spread to your spine and is causing pain. SBRT is~     delivered at a higher dose for a shorter period of time when compared to standard radiation~     therapy and the aim is to see if there will be an improvement both in pain control and your~     cancer It is not known whether SBRT is better or worse than current standard therapy. If you~     are selected to receive the experimental treatment in this research study, SBRT uses highly~     focused x-rays that deliver a single high dose to a specific area of the spine compared to~     conventional standard radiation over a period of 10 days which has been the standard proven~     treatment to help your condition. The investigators will also determine which treatment~     provides the most rapid pain relief with the least side effects. It is possible that SBRT may~     not be better or could be more toxic. The investigators will conduct quality of life~     assessments and pain scale index to assess how you are feeling once you have had the~     intervention.~   "
155887|NCT01525732|"~     Spastic esophageal motility disorders induced significant symptoms including dysphagia,~     retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel~     approach to perform myotomy through the esophagus with long submucosal tunnel. This study~     aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from~     animal study to clinical practice in human.~   "
155888|NCT01525719|"~     The purpose of this study is to determine whether everolimus is effective in the treatment of~     patients with advance cholangiocarcinoma.~   "
155889|NCT01525706|"~     Pancreatic cysts are becoming diagnosed more frequently due to the increased use and~     sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested~     treatment is surgery for removal. However, surgery involves significant risks and emerging~     opinion suggests that not all cysts need to be surgically removed. An alternative therapy~     would be ideal, in particular for those where surgical risk outweighs the benefits of~     resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to~     surgical resection.~      Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for~     treatment in those with per-cancerous, mucinous pancreatic cysts.~   "
155890|NCT01525693|"~     This is a study to gain better understanding on how those patients who are newly diagnosed~     with type 2 diabetes are treated and monitored. The study will record information such as~     type of therapy, therapeutic outcomes, and patients' satisfaction.~   "
155891|NCT01525680|"~     This study seeks to examine the efficacy of hydrocortisone administration in the augmentation~     of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested~     treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD).~     The augmentation builds on both the translation of neuroscience findings demonstrating the~     effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other~     investigators demonstrating beneficial effects of GCs in reducing traumatic memories in~     trauma-exposed persons.~   "
155892|NCT01525667|"~     Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of~     injured gluteal musculature after Total Hip Arthroplasty (THA).~   "
155893|NCT01525654|"~     The goal of PARASS is to develop a network of increased social support for Rheumatoid~     Arthritis (RA) patients that will improve patient outcomes and further promote understanding~     of RA among physicians and patients in the clinic community. This will be accomplished with~     the development and implementation of Buddy pairing and one -on- one informational support to~     be called Patient-to-Patient Connection.~   "
155894|NCT01525641|"~     Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily~     use of Mirapex®-LA Tablets in patients with Parkinson's disease.~   "
155895|NCT01525628|"~     To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their~     combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment~     naive or prior treatment relapse patients with chronic hepatitis C infection.~   "
155896|NCT01525615|"~     The primary objective of this study is to compare the effects of orally inhaled tiotropium +~     olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after~     12 weeks of treatment in patients with COPD.~   "
155897|NCT01525602|"~     The goal of this clinical study is to learn how PLX3397 and paclitaxel work together to~     affect the growth of cancer cells in advanced solid tumors.~   "
155898|NCT01525589|"~     A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of~     PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts~     response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety~     profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD~     (pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx)~     expression profile in tumor samples.~   "
155899|NCT01525576|"~     In this trial, we test if adding an Internet-based booster program to regular Internet-based~     cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive~     disorder (OCD).~   "
191719|NCT01054872|"~     The purpose of this study is to examine the role of genetics in determining the immune~     response to an HIV vaccine in pairs of HIV-uninfected twins.~   "
155900|NCT01525563|"~     In India Duphaston is approved and widely used for the treatment of progesterone deficiencies~     such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular~     cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual~     abortion, infertility due to luteal insufficiency, as well as part of hormone replacement~     therapy. One Indian study reported normalization of the cycle in 91.6% of women with~     menstrual problems after three cycles of therapy with dydrogesterone 10 mg given from 11th to~     the 25th day of the menstrual cycle. The mean cycle duration during dydrogesterone therapy in~     this study was noted to be 28.8 days, in contrast to 17.9 days (in the polymenorrhea group)~     and 50.6 days (in the oligomenorrhea group) before therapy. Furthermore, dydrogesterone also~     decreased the amount and duration of menstrual bleeding in this study.~      However, there are limited data regarding Duphaston's role in achieving cycle regularization~     from post-marketing settings. Moreover, it is not well-known if the effect of Duphaston~     therapy persists after cessation of treatment and whether the persistent effect, if any, is~     related to the duration of Duphaston therapy.~      Hence, in this observational study, given that (based on previous clinical studies as~     mentioned above) Duphaston plays a role in menstrual irregularities treatment, the goal is to~     tease out the possible implications of such treatment in terms of treatment length and~     response pattern.~   "
155901|NCT01525550|"~     The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with~     unresectable pancreatic neuroendocrine tumors.~   "
155902|NCT01525537|"~     The aim of the present study was to compare SPI guided analgesia with standard clinical~     practise during general anesthesia using a balanced setting of sevoflurane and sufentanil~     anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular~     stability, less use of analgetics and shorter recovery from anesthesia.~   "
155903|NCT01525524|"~     Stroke is one of the main public health problems in America Latina. It can be associated with~     several neuropsychiatric complications, which include a broad spectrum of emotional distress~     and cognitive, results in important clinical implications for the prognosis of these~     patients. Depression is a common complication, affecting around 5-72% of patients and is~     associated with various cognitive deficits and also with increased mortality - up to 50% more~     deaths compared to non-depressed patients. Treatment of depression after stroke is important~     not only to improve depressive symptoms but can also be beneficial for cognitive deficits,~     activities of daily living. and leads to increased survival for these patients. There are~     different treatments for depression after stroke, all showing inconclusive results, even~     though antidepressants have been effective in some groups of patients, tolerability and~     treatment adherence were not very good-so it is necessary that new therapeutic modalities are~     presented with good tolerability. In this sense, transcranial direct current stimulation~     (tDCS) is an interesting technique that can provide interesting results, which proved to be~     effective for depression in some studies. This study proposes to investigate the effect of~     tDCS for the treatment of major depressive disorder after stroke. The proposed design is a~     clinical trial, randomized, double-blind, placebo-controlled study in a subsample of~     participants in the prospective cohort of stroke: Study of Morbidity and Mortality of stroke.~     They will be allocated to one of the groups: sham or active tDCS group. Participants will~     receive ten consecutive days of active or sham stimulation and return at the end of two weeks~     to evaluate the improvement in depression, cognition and functionality. As objectives, the~     investigators expect to see a clinical improvement of depression through scales like~     Hamilton, Beck and MADRS(Montgomery-Asberg Depression Rating Scale), and expect improvement~     on cognitive tests as MoCA (Montreal Cognitive Assessment), MMSE (mini mental scale exam),~     FAB (frontal assessment battery) and trail test. Another goal is to see improvement in~     markers related to depression as BDNF, cortisol, interleukins and heart rate variability.~     With all this, the investigators hope to offer a new treatment, and effective with few side~     effects to treat depression after stroke.~   "
155904|NCT01525511|"~     The observed changes of P. falciparum sensitivity to artemisinin leads to the intensification~     of early detection as well as treatment monitoring in malaria infection. It is widely~     accepted that the development of resistance can be delayed by the use of combination therapy,~     especially artemisinin-based combination therapies (ACTs). The resistance problem is~     considered extremely serious and as the consequence WHO has recommended that all monotherapy~     for malaria should be stopped Current WHO guideline recommends the drug combination regimens~     using ACT with effective partner medicines to decrease the risk of development or spreading~     of artemisinin resistance.~      Dihydroartemisinin-piperaquine (DHA-PQP); the fixed-dose combination of Dihydroartemisinin~     (DHA) and Piperaquine phosphate (PQP) is now one of the recommended drugs by WHO as the oral~     treatment for uncomplicated P. falciparum. DHA-PQP composes of both blood schizonticidal~     drugs, with different mechanism of action and different half-life to improve the therapeutic~     efficacy and to prevent the development of drug resistance to the individual drug. Moreover,~     it is beneficial for the mutual protection against resistance and long lasting protection~     against new infection, due to long half-life of PQP.~      Primaquine is an effective gametocytocidal for P. falciparum transmission prevention and as~     tissue killing for the radical cure in Plasmodium vivax and Plasmodium ovale infection. It~     will be given only in the presence of other antimalarials, so it is necessary that the data~     of the potential drugs interaction of primaquine and DHA-PQP should be characterized. It is~     inevitable that in the near future, Dihydroartemisinin-piperaquine (DHA-PQP) and primaquine~     combination treatment becomes necessary. These drugs are metabolized by cytochrome P450~     enzyme which potentially causes pharmacokinetic alteration, resulting in clinically~     significant drug-drug interactions that can cause unanticipated adverse reactions or~     therapeutic failures because of the suboptimal exposure of the parasite.~      This study is planned to evaluate potential pharmacokinetic interaction of orally~     administered primaquine (PQ) and dihydroartemisinin-piperaquine (DHA-PQP) in healthy adult~     subjects. The results of these interaction studies are important in order to provide clinical~     guidance for the optimum combination of primaquine and DHA-PQP treatment regimens in malaria~     infections.~   "
155905|NCT01525498|"~     The objective of this study is to prospectively evaluate the effects of early versus delayed~     removal of transuretheral catheters following sacrocolpopexy. The investigators specific aim~     is to determine the optimal time of removal of an indwelling transurethral catheter~     postoperatively in an effort to reduce the risk of postoperative urinary retention and~     urinary tract infection associated with catheter use. The investigators hypotheses are as~     follows:~      Hypothesis 1: Longer duration of postoperative catheter use will result in decreased~     postoperative urinary retention.~      Hypothesis 2: Shorter duration of postoperative catheter use will result in lower incidence~     of urinary tract infection.~   "
155906|NCT01525485|"~     This prospective study compares quality of life measures of patients with refractory~     overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation~     (Group A) and sacral nerve stimulation (Group B).~      The specific aims are:~      1. To characterize patient symptom bother score, quality of life, and body image scores in~     patients obtaining sacral nerve stimulation, as compared to vaginal electrical stimulation.~      - Hypothesis 1: Both modes of neuromodulation will impact patients' scores in quality of~     life, patient symptoms, and body image questionnaires.~   "
155927|NCT01525199|"~     The purpose of this trial is to compare the evolution of patients receiving first line~     treatment for locally advanced or metastatic lung cancer, taking into account if they were~     requested or not the EGFR mutation test as part of the diagnosis and treatment strategy.~     There is no assignment to any particular therapeutic strategy.~   "
156010|NCT01524094|"~     The purpose of this study is to see if there is a difference in survival between two~     different treatment strategies for colorectal peritoneal surface disease. The control arm~     administered the currently considered standard treatment which is palliative systemic~     chemotherapy. The experimental arm received the combination treatment cytoreductive surgery~     and intraperitoneal chemotherapy. The investigators hypothesis is that the combination~     treatment will improve the overall survival.~   "
155907|NCT01525472|"~     Numerous epidemiological studies clearly showed the relationship between the excessive growth~     of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes and~     other cardiovascular risk factors. However, the mechanisms contributing to the deleterious~     role of visceral adipose tissue remain to be elucidated. Several observations suggest that~     adipose tissue depots exhibit distinct metabolic and secretory capacities according to their~     locations. We have recently shown that visceral fat depots display higher immuno-inflammatory~     cells infiltration than that of subcutaneous fat. In addition, the endothelial cells of~     visceral compared to subcutaneous adipose tissues express a pro-inflammatory phenotype and~     several markers related to aging. Finally, we have shown that visceral adipocyte-derived~     secretions promote the endothelial cell senescence in an extent higher than subcutaneous~     adipocyte-derived products. These data suggest that senescence 1) might be a phenomenon~     related to the location and therefore the microenvironment of adipose tissue and 2) might be~     responsible for an abnormal activation of proinflammatory response, favouring the development~     of metabolic and secretory dysfunction of adipose tissue in obesity. Our working hypothesis,~     based on these observations, is that the visceral adipose tissue provides a microenvironment~     that promotes accelerated aging. This senescence may be responsible for the establishment of~     an inflammatory reaction, alteration of the metabolic activity and adipocyte differentiation~     capacity of progenitor cells leading to the development of obesity associated diseases.~      The proposed project is a descriptive cross-sectional pathophysiological study .The aims are~     1) to better define the process of senescence in human adipose tissue, 2) to precise the~     mechanisms and 3) to analyse the cellular and functional consequences of aging on~     inflammation, adipose tissue development and metabolism. 200 morbidly obese candidates for~     bariatric surgery will be studied. The collection of clinical and laboratory data and the~     collection of biological samples (plasma, blood cells and subcutaneous and visceral adipose~     tissues) will be made at the inclusion and during surgery (obesity center, Hôpital Louis~     Mourier). Analyses of adipose tissue will be performed at INSERM U1048 and will focus on in~     vitro approaches of the cells of the adipose tissues (mature adipocytes, endothelial cells,~     progenitor cells and immuno-inflammatory cells).~      This project will permit to better understand the pathogenicity associated with the excessive~     growth of visceral adipose tissue and may reveal new therapeutic targets to limit~     obesity-associated pathologies.~   "
155908|NCT01525459|"~     Study on glioma patients treated with brain surgery is focusing on the analysis of their~     transcriptome expression profile measured in two immune cell populations, CD4+ T cells and~     CD56+ NK cells. The results of analysis will be compared to the reference data of healthy~     population. Furthermore, the metabolomic and immunological status will also be monitored and~     compared to healthy group reference data, before and after the surgery*. With comparative~     crossomics analysis the investigators intend to possibly identify new diagnostic and~     prognostic biological markers for the relapse of the disease. The results are expected to~     convey a deeper insight into pathophysiology of the glioma as well as into the mechanisms of~     the current surgical therapy.~      * The healthy reference data have been published in collaborative efforts of BTC, UMC and NIB~     (Gruden et al. 2012).~   "
155909|NCT01525446|"~     Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints~     high doses of radiation directly to cancer. Standard radiation (or photon radiation) is~     commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is~     a special type of radiation only available at a few institutions in the US and has not been~     previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy~     of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.~      In this study, the investigators are evaluating the safety and effectiveness of proton-based~     SBRT for early-stage NSCLC located in the periphery of the lung.~   "
155910|NCT01525433|"~     In this study, 400 Hispanic women will be recruited and randomized to one of three~     interventions:~        1. Control (no change);~        2. A low-intensity information program, consisting of a video approach educating women on~          the importance of cervical cancer screening;~        3. A higher intensity program consisting of the video plus a 'promotora' or lay-community~          health educator led intervention at the participant's home to encourage cervical cancer~          screening.~      The investigators will compare which intervention is most effective in encouraging Hispanic~     women to undergo cervical cancer screening (Pap test)~   "
155911|NCT01525420|"~     The purpose of this study is to demonstrate that Acceptance Therapy (ACT's) implementation~     outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).~      Implementation outcomes:~        -  end of treatment and 6-month follow-up data retention rates;~        -  intervention implementation quality;~        -  number & length of calls completed.~      Comparison of each arm's implementation~   "
155912|NCT01525407|"~     This phase II trial studies donor atorvastatin treatment for the prevention of severe acute~     graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem~     cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a~     donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the~     patient's immune system reject the donor's stem cells. When the healthy stem cells from a~     donor are infused into the patient they may help the patient's bone marrow make stem cells,~     red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a~     donor can make an immune response against the body's normal cells. Giving atorvastatin to the~     donor before transplant may prevent this from happening.~   "
155913|NCT01525394|"~     This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled,~     three-treatment, three-way crossover study in healthy subjects. There are two phases in this~     study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening~     and Baseline Period 1. The Randomization Phase consists of five periods: Treatment Period 1,~     Baseline Period 2, Treatment Period 2, Baseline Period 3, and Treatment Period 3. Completion~     of study termination procedures will be performed at Visit 11.~   "
155914|NCT01525381|"~     Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by~     a physician within the previous five years. It will be determined what diagnostic tests were~     initially performed to make this diagnosis. Participants will undergo lung function testing~     over 6-8 weeks to determine their respiratory status and to confirm they have asthma.~     Participants may be followed up to one year depending on their test results.~   "
155942|NCT01524991|"~     Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab~     has shown intriguing activity as neoadjuvant therapy in patients with clinically localized~     bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin, plus~     ipilimumab may build on the chemosensitivity of urothelial carcinoma to produce more durable~     responses and improved outcomes.~   "
155943|NCT01524978|"~     This open-label, multi-center study will assess the efficacy and safety of vemurafenib in~     participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma,~     except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best~     treatment option in the opinion of the investigator. Participants will receive twice daily~     oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or~     withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab~     in a subset of participants with colorectal cancer will also be assessed.~   "
155915|NCT01525368|"~     Cognitive training has been shown to be successful in patients with amnestic mild cognitive~     impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a~     randomized controlled trial, the investigators recently found that aMCI patients receiving a~     cognitive intervention showed stable hypometabolism in FDG-PET, whereas patients in an active~     control group showed pronounced hypometabolism on follow-up scans in regions typically~     affected in AD.~      Previous studies indicate that not all patients respond equally well to a cognitive~     intervention. Identifying factors that predict response to treatment could help selecting~     patients for a targeted intervention. A potentially important predictor is cognitive reserve~     defined as premorbid cognitive performance. The hypothesis is that different levels of~     cognitive reserve (high cognitive reserve vs. low cognitive reserve) have different~     neurostructural and neurofunctional correlates and influence treatment response in a~     different way. Moreover, the impact of white matter lesions on treatment effects will be~     investigated.~      The investigator will perform a complex cognitive training program. Forty patients with aMCI~     (20 with high cognitive reserve, 20 with low cognitive reserve) will be recruited in this~     study. Since the patients are recruited consecutively, an estimated overall number of 80 will~     be included and receive the training of whom about 40 will meet the inclusion criteria for~     our cognitive-reserve-study (high or low cognitive reserve). Data of the whole group will be~     used to analyze the potential impact of white matter lesions on response to the intervention.~     Cognitive effects of the intervention will be evaluated by neuropsychological testing.~     Neurofunctional and neurostructural changes depending on cognitive reserve will be measured~     using resting state fMRI and diffusion tensor imaging (DTI).~      For comparison, a group of 30 aMCI patients will be recruited as an active control group~     receiving study investigations (neuropsychological testing as well as MRIs), and exercises~     for self-study at home, not the complex cognitive intervention.~   "
155916|NCT01525355|"~     Performing an EUS prior to ERCP in the setting of a positive intraoperative cholangiogram~     will identify and risk stratify patients for the presence of CBD stones and strictures.~   "
155917|NCT01525329|"~     This randomized, intra-patient comparative study is designed to investigate the combination~     regimen of 5-FU and PDT, versus PDT alone, for its ability to generate significantly elevated~     levels of the target photosensitizer, PpIX, in lesions of actinic keratoses (AKs) and to more~     effectively treat and prevent recurrence of AKs. The target population comprises patients~     with solid organ transplants (renal, hepatic), as well as normal (immunocompetent) subjects~     to control for possible influences of immunosuppression.~   "
155918|NCT01525316|"~     The investigators propose a clinical trial in premature infants to determine the effect of~     orally-administered bovine lactoferrin on occurrence of severe infections and to determine~     whether as a result of decreased infections, infants' growth and development improve after~     daily lactoferrin supplementation, due to its antimicrobial and anti-inflammatory properties.~     If successful, the use of lactoferrin as a protective protein could profoundly affect~     clinical care of neonates both in the developed and developing world.~   "
155919|NCT01525303|"~     This proposed study seeks to examine whether adding an aerobic exercise prescription to a~     behavioral treatment program for chronic headaches will improve headache frequency and~     intensity, headache-related disability, and mood. It is hypothesized that participants who~     receive the exercise prescription at the start of treatment will show greater gains than~     those who receive the prescription halfway through treatment. It is also predicted that~     participants who begin the exercise component halfway through treatment will demonstrate~     greater improvement in the second half of treatment compared to the first half.~   "
155920|NCT01525290|"~     WAKE-UP is an investigator initiated European multicenter randomized controlled clinical~     trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset,~     e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove~     efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking~     up with stroke symptoms or patients with otherwise unknown symptom onset.~   "
155921|NCT01525277|"~     Whether the side of implantable CVCs was associated with the complication rates remains~     unclear. The investigators plan this study to explore this issue by randomizing patients to~     receive CVC implantation at the left subclavian or righ subclavian vein.~   "
155922|NCT01525264|"~     Breast cancer is the most commonly occurring cancer and most common cause of cancer mortality~     among Korean American (KA) women, but mammography utilization among KA women remains~     suboptimal. Most breast cancer screening studies with KA women have been descriptive and~     correlational. Therefore, in this 4-year project, the effects of Korean Immigrants &~     Mammography—Culture-Specific Health Intervention (KIM-CHI) on adherence to recommended breast~     cancer screening protocols were tested. The specific aims are to: (1) compare the group~     receiving KIM-CHI with an attention control group on mammogram attainment outcomes including~     number of mammograms obtained (0, 1, or 2) and if obtained, length of time to obtain the~     first mammogram, at 15 months using survival analysis; (2) compare the two groups on the~     mediating variables of health beliefs, knowledge, self-efficacy, and spousal support at 2~     weeks, 6 months, and 15 months using repeated measures multivariate analysis of variance; and~     (3) identify the mediating effects of health beliefs, knowledge, self-efficacy, and spousal~     support at 2 weeks on mammogram attainment outcomes at 15 months, using structural equation~     modeling. Data on mammography attainment and the mediating variables were collected at~     baseline and at 2-weeks, and 6- and 15-months post-baseline.~   "
155923|NCT01525251|"~     Clinical Problem and Significance: The incidence of neuroblastoma is about 30 cases a year in~     Taiwan. The five-year survival rate of neuroblastom is near 50% in Taiwan. Compared to the~     survival rate in Western countries, the treatment in Taiwan needs more efforts to improve.~     According to the report from the Childhood Cancer Foundation ROC, several children with~     neuroblastoma did not complete their treatment and or not received the protocol. In addition~     to the efforts in improving protocol, the reasons for those who drop-out and do not receive~     complete treatment need the investigators more attention to think of.~      Purpose of Study: The main purpose is to evaluate the effects of nurse case manager model on~     caregivers' adaptation of disease uncertainty about then child with neuroblastorna.~      Methods: A longitudinal and prospective design will be used to perform this study.~     Questionnaire survey and chart review will be the means of data collection for the part of~     quantative analysis. The qualitative method , semi-structural interview , also will be used~     to collect data regarding caregiver's perception of social support and adaptation at the same~     time of self-report of questionnaires survey .There are five points of time to collect data:~     Baseline (A), 3 months(B) , 6 months(C), 9 months(D),1 year(E) and 1.5 year(F) after eligible~     subjects agree to participate in the study.~      Subjects: The study will use a convenience sample. Once the caregiver's child is on has been~     diagnosed with neuroblastoma will be recruited in this study.~      Instruments: Three Chinese versions of Mishel Uncertainty in Illness-Parent Form , the~     self-reported socio-demographic questionnaire will be used to collect data. Process recording~     will be typed once finishing interview for further analysis.~      Data Analysis: Quantitative data will be analyzed using SPSS 15.0 statistical software. The~     data will be analyzed using descriptive statistics and inferred statistics. Content analysis~     and theme formation will be categorized to assist the interpretation of quantitative results.~      Implication: The findings of this study will be expected of the effects of nurse care manager~     model on children with newoblastoma cancer survivors.~   "
155924|NCT01525238|"~     The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin~     in pediatric subjects with type 2 diabetes mellitus (T2DM)~   "
155925|NCT01525225|"~     The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy~     Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM)~     following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet~     and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets~   "
155928|NCT01525186|"~     Background:~      A topic of interest in the etiology of child obesity is if and how parental feeding behaviors~     are associated with child food intake and weight status.~      Objectives:~      The objective was to explore if and how directive (overt) and non-directive (covert and food~     environmental structure) types of parental feeding control were associated with children's~     food intake and weight status.~      Design:~      This was a cross-sectional, exploratory study using structural equation modeling to determine~     directional associations between maternal feeding practices and their child's food intakes~     and weight status. Researchers collected data from 330 dyads of 3-5yr children and mothers~     participating in a federal preschool program for low-income families (Head Start) in~     Michigan. Mothers' feeding practices (directive and non-directive control), children's food~     intakes, height and weight of both mothers and children were measured. Structural equation~     models tested the relationships between maternal feeding practices, the child's food intake~     and weight status.~      Hypotheses:~        1. Child weight is negatively associated with parents' directive feeding control practices.~        2. Less directive control or greater non-directive control is associated with healthier~          food intakes in children.~   "
155929|NCT01525173|"~     This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic~     solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine~     tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated~     with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular~     pressure (IOP) lowering medication.~   "
155930|NCT01525160|"~     Obstructive Sleep Apnoea Hypopnoea Syndrome(OSAHS)affects at least 4% of males and 2% of~     females.~      OSAHS is the combination of excessive daytime sleepiness, snoring and apnoeas (stopping~     breathing at night). As well as affecting tiredness, mood, concentration and quality of life~     - there is growing concern that it can increase the risk of high blood pressure, heart~     problems, strokes and thromboses (clots in the veins).~      It appears that OSAHS may affect the thickness of the blood and cause it to clot more easily~     it also causes damage to the lining of the blood vessels (endothelial injury). These effects~     seem independent of other risk factors such as obesity, smoking, family history of clots etc.~      The investigators are testing new biomarkers: gel point and fractal dimension developed at~     the Swansea University to measure the 'clotting' of the blood in people with OSAHS and a~     similar group of people who snore and who are sleepy but do not have OSAHS on sleep studies~     (Controls) Also markers of vascular inflammation are being measured.~   "
155931|NCT01525147|"~     A block-randomized, double-blind, placebo-controlled, single-dose escalating, phase I~     clinical trial to evaluate the safety, tolerability and pharmacokinetics of YHB1411-2 in~     healthy male volunteers~   "
155932|NCT01525134|"~     The purpose of this study is to evaluate the accuracy, diagnostic yield, operational~     performance, and time to diagnosis of a novel lateral-flow urine lipoarabinomannan (LAM) test~     in detecting tuberculosis in HIV-infected adults.~      A secondary study objective is to determine the accuracy, efficiency, costs, and~     cost-effectiveness of various combinations of Tuberculosis (TB) diagnostic tests, including~     the novel Xpert MTB/Rif test.~   "
155933|NCT01525121|"~     This is a randomized crossover study, designed to evaluate if the manual expiratory rib cage~     compression technique improves respiratory mechanics and is effective in secretion removal in~     mechanically ventilated patients.~   "
155934|NCT01525108|"~     In this study the investigators aim to evaluate the effect of home-based blood pressure~     measurement with an electronic device on medication adherence and blood pressure control.~   "
155935|NCT01525095|"~     The purpose of this study is to assure the uniform collection, handling, storage and~     transport of patient whole blood specimens and associated information to support validation~     of the T2 Candida Assay.~   "
155936|NCT01525082|"~     The purpose of this research is to evaluate the effectiveness and safety of a combination of~     capecitabine, temozolomide and bevacizumab in the treatment of advanced pancreatic~     neuroendocrine tumors.~   "
155937|NCT01525069|"~     This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial~     infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic~     drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by~     surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver~     tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or~     gemcitabine may significantly improve clinical outcomes of patients with locally advanced~     cholangiocarcinoma.~   "
155938|NCT01525056|"~     The purpose of this study is to evaluate the accuracy of Positron emission tomography,~     Computed Tomography perfusion and 3 Tesla MRI in the radiological down-staging of rectal~     cancer following neoadjuvant chemoradiation. The restaging result obtained by these imaging~     studies will be compared to standard imaging studies and the histopathology of the surgical~     specimen. We hypothesize that these 3 imaging modalities will detect lymph node metastases~     pretreatment better than standard pretreatment scans and will better determine the degree of~     response of the primary rectal tumor to preoperative chemoradiation.~   "
155939|NCT01525043|"~     The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients~     with lateral and medial epicondylitis and compare it to Naproxen sodius.~   "
155940|NCT01525017|"~     The primary objective of this study is to answer the question Is it possible to inject the~     Combig-DC vaccine in a renal tumour without getting unacceptable side effects? Patients~     newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two~     occasions in a two weeks period (day 1 and day 14). After another two weeks the kidney will~     be eliminated. Adverse events will be registered, as well as changes in vital signs(heart~     rate, blood pressure and body temperature) and lab parameters. Immunologic response will be~     evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size~     of the metastases three months after nephrectomy.~   "
155941|NCT01525004|"~     This is a phase I trial in which the both the safety and immunogenicity of the standard dose~     flu vaccine will be compared with high dose flu vaccine in children that have undergone solid~     organ transplantation (SOT).~   "
156062|NCT01523418|"~     The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis~     of VTE in Indian patients undergoing elective TKR/THR~   "
191720|NCT01054859|"~     The purpose of this study is primarily to evaluate whether taking avanafil with alcohol~     causes the blood pressure to fall.~   "
155944|NCT01524965|"~     Open reduction and locking plate osteosynthesis is a commonly used and well-accepted~     treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff~     despite intensive rehabilitation, limiting the function of the upper extremity and decreasing~     the quality of life. The accepted postoperative mobilisation protocol includes passive~     exercises until six weeks postoperatively and active range of motion exercises after that.~     There is good evidence that conservatively treated fractures of the same site heal better and~     faster if mobilised immediately. The study compares standard mobilisation versus~     immmediate mobilisation in a prospective, randomized, controlled trial in order to find the~     optimal time-frame for physiotherapy to produce best possible results. Outcome measures are~     assessed at specific time points after the operation and comparisons between groups are made~     to follow the rate of recovery and end results.~   "
155945|NCT01524952|"~     Objective:~      It is unclear whether prolonged electrical muscle stimulation can improve cardiorespiratory~     fitness and reduce body fat in obese subjects. The purpose of this study is to investigate~     the effect of prolonged combined thermal and electrical muscle stimulation (cTEMS) on peak~     oxygen consumption (VO2 peak) and body composition. We will also investigate the biochemical~     effects and the resultant lipolysis-related gene expression changes in adipocytes.~      Methods:Eleven obese (BMI≥30) individuals will receive cTEMS in three 60-minute sessions per~     week for 8 weeks. Activity levels and dietary habits will be kept unchanged and controlled~     with an accelerometer and nutritional questionnaire. Before and after the stimulation period,~     functional capacity are assessed by VO2 peak, and body composition was assessed by~     dual-energy X-ray absorptiometry and bioelectrical impedance analyses. Lipolytic activity~     will be determined in abdominal adipose tissue by 24 hours of microdialysis on a sedentary~     day, and adipose tissue biopsies will be taken for the gene expression analysis.~   "
155946|NCT01524939|"~     The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin~     Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.~   "
155947|NCT01524926|"~     The study will primarily assess the antitumor activity of crizotinib in a variety of tumors~     with alterations in ALK and/or MET pathways. The targeted patient population will include~     patients with tumors harboring specific alterations leading to ALK and/or MET activation,~     where tyrosine kinase inhibitors against these targets have not yet been adequately explored.~   "
155948|NCT01524913|"~     The purpose of this study is to determine whether the administration of hyaluronic acid or~     corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain~     relief and improved function.~      The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the~     mean visual analogue scale (VAS) at one month when compared to celestone and placebo.~   "
155949|NCT01524900|"~     This Post Marketing Surveillance study will be performed as an open-label, prospective,~     non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected~     patients. Data will only be documented in patients for whom a pharmacotherapy with nevirapine~     extended release is initiated. Both anti-retroviral therapy (ART) naïve patients and~     pre-treated patients switching from nevirapine immediate release or other anti-retroviral~     therapy (ART) will be included in the study. The decision to initiate treatment with~     nevirapine extended release is independent of this study and is based entirely on individual~     patient need and the judgement of the treating physician. The aim of the study is to assess~     the safety and efficacy and treatment adherence of nevirapine extended release in HIV-1~     infected patients in routine clinical practice. It is planned to document five visits for~     each patient over a twenty four week observational period.~   "
155950|NCT01524887|"~     The purpose of this study is to provide evidence of efficacy and safety to support the~     development of IGIV, 10% as a treatment option for patients with mild to moderate Alzheimer´s~     Disease.~   "
155951|NCT01524874|"~     The importance of vitamin D (VitD) in the prevention and treatment of human health conditions~     has gained increased attention in recent years. As a result, medical providers of all~     categories are screening clinical VitD status frequently, yet become challenged with how to~     best advise patients regarding repletion of VitD status, i.e. which form of VitD replacement~     is most effective. It has been recognized that to achieve significant effects - serum~     concentrations >30ng/ml (75 nmol/ml) - it is necessary, as well as safe, to recommend~     substantially higher doses than were previously thought sufficient. These higher doses can be~     easily achieved orally. This clinical trial aims to compare absorption of three available~     forms of this fat-soluble vitamin, due to the potential differences in absorption of~     different preparations. High-quality powdered, chewable and lipid-emulsified VitD are readily~     available as supplements, yet these have not been systematically compared. This three-arm,~     randomized clinical trial will compare the difference in serum 25-hydroxycholecalciferol~     (25-OH)D concentration between the three arms at baseline and after random administration of~     one of the three VitD preparations for 12-weeks at a dosage of 10,000 IU VitD per day. The~     investigators hypothesize that the three forms of vitD will result in an equivalent increase~     in serum 25OHD.~   "
155968|NCT01524653|"~     Patients with cancer have a high risk of developing venous blood clots or thromboembolism~     (VTE). In an effort to target patients at highest risk of VTE for thromboprophylaxis~     (protective treatment for blood clots), numerous studies have identified serum biomarkers for~     risk of future VTE. There is also increasing evidence pointing to a prophylactic effect of~     statin therapy on the risk of developing VTE in high-risk populations including patients with~     advanced cancer. The purpose of this research study is to find out whether treatment with~     rosuvastatin (the study drug) reduces the risk of VTE in patients with cancer receiving~     chemotherapy. This study is specifically investigating the impact of rosuvastatin therapy on~     serum biomarkers (D-dimer and others) that indicate a risk for VTE, as well as safety and~     tolerance of rosuvastatin therapy in this population.~      This is a phase II randomized crossover study with two 3-4 week treatment periods during~     which all enrolled patients will receive 20 mg of rosuvastatin once a day by mouth or a~     matching placebo tablet. Approximately two tablespoons of blood will be collected for~     biomarker analysis at the beginning and end of each treatment period. After the first~     treatment period there will be a 3-5 week break where subjects will undergo a washout.~     Following this washout period every subject will crossover or begin taking the alternative~     therapy so everyone enrolled will receive the study drug either during the first or the~     second treatment period. Biomarker levels will be analyzed in both treatment periods and~     compared to baseline, with every patient acting as their own control.~   "
155952|NCT01524861|"~     Stress (tako-tsubo) cardiomyopathy (SC) is a rapidly reversible form of acute heart failure~     reported to be triggered by stressful events and associated with a distinctive left~     ventricular (LV) contraction pattern.~      SC mimics acute coronary syndrome and is accompanied by reversible left ventricular apical~     ballooning in the absence of angiographically significant coronary artery stenosis.~     sympathetic activity dysfunction appears to play a very important role in the pathophysiology~     of takotsubo cardiomyopathy.~      In most cases, myocardial scintillography with 123Imetaiodobenzylguanidine (MIBG) showed~     altered captation of the radiotracer in several heart segments. In particular, the apical~     myocardium has poor sympathetic innervations and an uptake reduction in MIBG tracer.~      A hypothesis for this finding could be that the intense discharge of adrenalin, acting on~     heart segment with different and abnormal innervation, may produce a transient heart failure~     characterized by a particular shape of the left ventricle.~      While studies have shown that heterogeneous MIBG distribution, decreased MIBG uptake and~     increased norepinephrine content were completely prevented by α-lipoic acid or by L-acetyl~     carnitine administrations in diabetic cardiomyopathy, no studies have examined the effects of~     these therapies on tako-tsubo cardiomyopathy.~      On this basis, the investigators study will evaluate whether the dysfunction of adrenergic~     cardiac innervation, evaluated by MIBG, persist after previous experience of transient~     stress-induced cardiac dysfunction. Moreover, the investigators will assess whether the~     medications that restore sympatho-vagal alterations in diabetic cardiomyopathy, such as~     α-lipoic acid and L-acetyl carnitine, will improve the adrenergic cardiac innervation, in~     patients with SC.~   "
155953|NCT01524848|"~     Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who~     develop resistance against the two hitherto approved drugs for this disease, the tyrosin~     kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further~     response may be achieved by other drugs, mainly other TKIs, which have been explored in~     different studies but not yet have been approved for clinical use. Pazopanib is a TKI~     inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles~     in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves~     investigational trials. The drug is approved for metastatic renal cancer and is relatively~     well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12~     weeks of treatment will be assessed as the primary endpoint, and at the same time trough~     levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control~     rate in relation to trough level week 12 and in relation to the primary mutation of the tumor~     (if known). The goal is to include 72 patients in the trial, which is open and single arm.~   "
155954|NCT01524835|"~     This study will gather information on the long-term effects of donating a lung lobe on living~     donors.~   "
155955|NCT01524822|"~     Background:~      - Repeated exposure to explosions may lead to changes in the way that people think or feel.~     Breachers (people trained to use explosives to get into buildings) are exposed to repeated~     blasts as part of their job. Researchers want to study how they might be affected by blast~     exposure. Breachers will be compared with other groups who have different levels of exposure~     to repeated blasts. Information will also be obtained from spouses or close companions.~      Objectives:~      - To study the effects of repeated exposure to low-level blasts on thinking, memory,~     behavior, and brain function.~      Eligibility:~        -  Experienced military and civilian breachers, experienced active duty artillery~          operators, and active duty military without frequent blast exposure, 18 and 60 years of~          age.~        -  Spouses or close companions of these individuals.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected and a urine pregnancy test will be required of participants (not~          companions) before MRI scanning.~        -  Participants will spend up to 5-days as a NIH clinic outpatient, with about 6 hours of~          tests each day. Tests will include the following:~        -  Medical and professional history, with questions about exposures to blasts~        -  Tests of thinking, memory, and concentration~        -  Balance tests~        -  Hearing tests~        -  Imaging studies, such as magnetic resonance imaging, to look at the brain~        -  Overnight sleep study to monitor brain waves~        -  Blood samples~        -  Participants will return 1 year later for a 3-day followup visit. Some of the tests from~          before will be repeated. A spouse or close companion (if available) will be asked to~          complete questionnaires or have a telephone interview.~   "
155956|NCT01524809|"~     This trial is conducted in Europe. The aim of this trial is to investigate steady state~     pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects~     with type 1 diabetes.~   "
155957|NCT01524796|"~     Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the~     treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.~   "
155958|NCT01524783|"~     The purpose of this study is to compare the antitumor activity of everolimus plus best~     supportive care versus placebo plus best supportive care in patients with advanced~     nonfunctional neuroendocrine tumor of gastrointestinal or lung origin.~   "
155959|NCT01524770|"~     The study involves 2 injections of 1.5 milligrams (mg) dulaglutide, 1 given by a pre-filled~     manual syringe, the other given by an auto-injector. Injections will be separated by a~     minimum 28-day washout period. The study will evaluate if the levels of drug in the blood are~     similar when given by each method. Participation in the study is likely to take approximately~     7 weeks, not including screening.~   "
155969|NCT01524640|"~     This is a randomized, double blind, placebo controlled trial to confirm the safety and~     determine the immune response of the killed oral cholera vaccine in healthy adults and~     children in Ethiopia.~   "
155970|NCT01524627|"~     Varenicline is the best smoking cessation agent to date; however it is only effective in a~     subgroup of smokers and is associated with undesirable side effects in other subgroups. To~     understand the underlying pharmaco-heterogeneity, the proposed project will use perfusion~     functional magnetic resonance imaging and a functional candidate gene association approach~     using brain, behavioral, and clinical endpoints in a placebo-controlled study of chronic~     varenicline administration in smokers. Brain and behavioral responses to smoking cues will be~     will be significantly greater in 9/10-repeats compared to 10/10-repeats. DAT 9/10-repeat~     smokers receiving varenicline will have better treatment outcome compared to 10/10-repeats.~     For the purposes of the clinical trial portion of the study, the change from cigarettes per~     day at Baseline to the last day of treatment will be reported.~   "
155960|NCT01524757|"~     Hereditary Hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in~     excessive iron overload causing damage of different important organs like heart, liver,~     pancreas and joints. Complications and symptoms can regress by intensive treatment reducing~     the iron overload stores.Different genes have been identified playing a role in the~     pathophysiology of iron overload. A clinically important HFE gene mutation is the C282Y,~     located on chromosome 6. Phlebotomy is currently the standard therapy which consists of~     removal of 500 ml whole blood weekly, representing a loss of 250 mg iron. In naive patients~     between 20 to 100 phlebotomies are required to reduce the serum ferritine levels to 50 μg/L.~     Thereafter, a lifelong maintenance therapy of 3 to 6 phlebotomies yearly is needed.~      For absorption, dietary iron ( 70%) is reduced by gastric acid form the ferric (Fe3+) to the~     ferrous form (Fe2+). Recently, in an observational open study, Hutchinson et al. found that~     HH patients treated with proton pump inhibitors (PPI) needed fewer phlebotomies, resulting in~     a drop of 2.5 (SEM 0.25) to 0.5 (SEM 0.25) liter per year.~      Research question: The primary objective is to determine the effectiveness and cost~     effectiveness of PPI's compared to standard phlebotomy therapy in the prevention of iron~     overload in HH patients.~      Multi-center trial in two hospitals in the South of Limburg (Atrium medical Center,~     Maastricht university medical center ) and hospital in Belgium (University Hospital~     Gasthuisberg). The study will be conducted in randomised double blind manner. The follow up~     will be one year.~      Patients are randomized either for the group receiving a PPI or a placebo. Every 2 month the~     ferritin level is measured and decided if the patient need a phlebotomy (Ferritin >100 µg/L).~   "
155961|NCT01524744|"~     The purpose of this study is to compare the effect of topical Pimecrolimus with adcortyl on~     erosive-atrophic 0ral lichen planus in a randomized clinical trial study.~   "
155962|NCT01524731|"~     Dexamethasone is a synthetic corticosteroid that has been proven to be effective and~     relatively safe for the prophylaxis of the postoperative nausea and vomiting (PONV).~      However, little is known about its effect on the hypothalamic-pituitary-adrenal (HPA) axis~     after surgery. The investigators hypothesize that it will inhibit the normal physiologic HPA~     surge and reduce cortisol levels post-operatively ia a dose-dependant fashion. To answer this~     question, the investigators will conduct a randomized, double-blinded placebo-controlled~     trial with two different doses of dexamethasone in women undergoing elective gynecologic~     laparotomy.~   "
155963|NCT01524718|"~     Hip fractures are one of the most frequent operated fractures procedures in orthopedics, with~     a world wide annual incidence of approximately 1.7 million. These fractures are associated~     with substantial morbidity and mortality. As populations age and life expectancy increases~     worldwide, the incidence of these fractures is likely to raise, expected to triple in the~     next 50 years. The use of fluoroscopy and resultant exposure to radiation, is an integral~     part of surgical procedures aiming to reduce and fixate the fractured femur. The risk of~     contracting cancer is significantly higher for an orthopedic surgeon as Hip surgery is a~     major slice of the total radiation dose. Optimal positioning and control of the imaging~     intensifier device may result in significant reduction of radiation dose and time and in~     substantial shortening of the procedure.~      The investigators hypothesis is that this technique would substantially shorten procedure~     time and reduce unnecessary radiation exposure for both the patient and the medical staff.~     Furthermore, by using this technique the investigators can eliminate the need for fluoroscopy~     technician during the surgery, as there is no need to alternate fluoroscopy views.~   "
155964|NCT01524705|"~     Results of recent studies using standard long and short acting insulin therapy (Basal - Bolus~     or BBI) in type 2 diabetes mellitus (T2DM) have not shown benefits to lower risks for heart~     attacks, strokes, or eye, nerve and kidney problems. Some studies also show a long time~     between the start of treatment and signs of benefit. This has led to a review of current ways~     to normalize blood glucose control with basal bolus insulin and how to make blood glucose~     better. Improving blood sugar with insulin therapy usually causes weight gain, more high~     sugar levels after meals, and more low blood sugars. Early studies suggest that when people~     take long-acting insulin and metformin, they have fewer blood sugar extremes when they also~     take a new type of medicine called glucagon-like polypeptide-1 (GLP-1) agonist named~     exenatide (Byetta), instead of meal-time insulin. This means there might be a better way to~     treat Type 2 diabetes.~      Participants are asked to take part in an eight month study to find out if middle-aged and~     older people with Type 2 diabetes who have added risk factors for heart disease can even out~     their blood sugar levels. They will start on long-acting insulin, mealtime insulin, and~     metformin, if they are not already on these medications. Their kidney function tests must be~     normal and they must not be allergic to metformin. Then, after a 2 month run-in phase, they~     must be willing to be assigned by chance into one of two groups. This means that they will~     have a 50/50 chance (like flipping a coin) of being in either group. Half of them will be~     started on the new medicine known as Byetta rather than the meal-time insulin and the other~     half will remain on the meal-time insulin during the next 6 months (26 weeks) to see which~     group has more steady blood sugars. They will be asked to use a continuous blood sugar~     monitoring system called DexCom. A sensor is inserted under the skin in the same areas the~     insulin is injected. The DexCom can check their blood sugars 24 hours of the day and night~     and will be worn until 7 days of recordings are collected. In the same 7 day period, they~     will also be asked to wear a Holter or Telemetry monitor that will record their heart beats~     and rhythm which will be compared to the blood sugar readings. They will also use home~     glucose meters to check their glucose levels about 3 to 4 times a day. The study will take~     place at 12 centers in the United States and enroll about 120-130 people.~   "
155965|NCT01524692|"~     The purpose of this study is to improve survival of patients with recurrent or metastatic~     Adenoid Cystic Carcinoma (ACC). This study will test the efficacy of the investigational~     drug, TKI258, in treating ACC.~   "
155966|NCT01524679|"~     A prospective, randomised, open-label phase IIb clinical trial assessing the effect of~     pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing~     nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B~      The primary objective of the trial is to investigate whether the add-on of pegylated~     interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the~     percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48~     weeks.~      170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an~     oral antiviral regimen and having a nondetectable viral load for at least 12 months are~     included.~   "
155967|NCT01524666|"~     This is a nonblinded Case-only study that evaluates the effects of Agmatine Sulfate on small~     fiber peripheral neuropathy. Patients will be started on Agmatine sulfate (a metabolite of~     Arginine) and monitored for two months. Improvement will be noted on their response to the~     Neuropathic Pain Questionnaire. Additionally the investigators will note improvement by~     performing autonomic function testing at the beginning and end of the study.~   "
156099|NCT01522937|"~     This is a Phase II trial to characterize the safety and efficacy of individualized~     stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment~     or who have primary hepatocellular carcinoma (HCC).~   "
155971|NCT01524614|"~     Upper airway obstruction (UAO) is common complication during induction of general anesthesia.~     The mechanism of UAO during anesthesia has not been well understood. Posterior displacement~     of soft palate are believed to be the primary contributing factors. The mechanism of UAO~     during anesthesia share many similarities with obstructive sleep apnea (OSA). Since nasal~     continuous positive airway pressure (nCPAP) can maintain the airway patent in patients with~     OSA, the investigators hypothesize that nCPAP during induction of anesthesia will reduce the~     incidence and severity of UAO.~   "
155972|NCT01524601|"~     Renal transplant recipients need life long immunosuppression and one of the new drugs is~     everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects~     are increased blood cholesterol levels. Many renal transplant recipients are treated with a~     cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering~     drug on the market with a potential higher cholesterol lowering potency. In the present study~     the investigators will examine the hypothesis that rosuvastatin reduce cholesterol levels~     more than fluvastatin in renal transplant patients.~   "
155973|NCT01524588|"~     Follicle-stimulating hormone (FSH) is used in medically assisted procreation, to induce an~     ovarian stimulation in women. However, the FSH dose that has to be injected is quite hard to~     adjust, because an excess of exogenous hormone could lead to very severe complications for~     patient. This hormone acts on its cognate receptor, the FSHR, present on the granulosa cells~     surface, and which regulation involve the intra-cytoplasmic carboxy-terminus domain.~      The investigators first aimed to research in the c-terminus part of the receptor the presence~     of allelic variants that could explain the variations of response to FSH stimulation.~      The investigators also would want to complete the data already known on a functionally~     determinant single nucleotide polymorphism on 680 position in the c-terminus part of the~     hFSHR.~      Then, the investigators would analyze the entire sequence of the hFSHR of patients presenting~     an unusual phenotype in response to FSH treatment, in order to detect a potential mutation~     involved in the receptor functionality.~      The results of this study could allow us to increase our knowledge on the hFSHR physiology~     and functionality, in order to adjust treatment to the genetic profile of patients.~   "
155974|NCT01524575|"~     The goal of this clinical trial is to improve and personalize pancreatic cancer care to~     deliver the most effective therapy while avoiding unnecessary exposure to potential side~     effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression~     predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are~     much more likely to respond to cisplatin than those whose tumors produce large amounts. The~     hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective~     regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of~     ERCC1.~   "
155975|NCT01524562|"~     Background:~      - Liver disease is a leading cause of death in people who have the human immunodeficiency~     virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses. Most~     research on HIV-related liver disease has been conducted in North America and Europe.~     However, HIV-related liver disease in Uganda and other African nations may involve other~     diseases that are not common in the West, and may not involve hepatitis B or C. Researchers~     want to study HIV-related liver disease in Uganda to learn more about the differences between~     Western and African trends of this disease.~      Objectives:~      - To study HIV-related liver disease in rural Uganda.~      Eligibility:~        -  Individuals at least 18 years of age who were tested for possible liver disease. Some~          participants will have HIV infection; others will be uninfected.~        -  All participants will be from rural areas of Uganda.~      Design:~        -  Participants will have at least two study visits.~        -  Participants will have a physical exam and medical history. They will complete a~          questionnaire about health and quality of life. Blood, urine, and stool samples will be~          collected. Participants will also have a liver scan to check for liver scarring, and an~          ultrasound to take images of the liver.~        -  Participants who may have liver disease will visit a local hospital for more tests. A~          liver biopsy will be performed to collect liver tissue samples.~   "
155976|NCT01524549|"~     Background:~      - The endothelium is the inner lining of blood vessels. The cells in this lining help~     regulate blood flow and immune system function. Problems with endothelial cells can~     contribute to heart disease, high blood pressure, and diabetes. Certain genes or parts of~     genes may be related to problems with endothelial function. Researchers want to study healthy~     adults who have genes that may affect their endothelial function. More information on these~     genes may provide more information on genetic risk for certain diseases.~      Objectives:~      - To study healthy adults who have genetic markers related to endothelial cell problems.~      Eligibility:~        -  Healthy volunteers between 18 and 65 years of age.~        -  Current participants of the Environmental Polymorphisms Registry and have certain genes~          related to endothelial cell problems.~      Design:~        -  Participants will have a single study visit to collect information and samples.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have an ultrasound of the artery in the arm and will be given a~          short-acting medication called nitroglycerin to study blood flow and blood pressure.~   "
155977|NCT01524536|"~     Background:~      - Hypereosinophilic syndrome (HES) is a disorder in which the body has too many eosinophils~     (a type of white blood cell). Too many eosinophils in HES can cause damage to the heart,~     nerves, or skin. Certain drugs can help lower eosinophil counts to prevent tissue damage.~     Corticosteroids, such as prednisone, are used for initial therapy in this disorder. Although~     most people respond to prednisone, some people develop side effects from it, or do not~     respond very well to treatment. Better ways of determining the dose to give could help to~     decide on the best therapy for HES.~      Objectives:~        -  To determine whether a single-dose of prednisone can be used to predict which people~          with hypereosinophilia respond to treatment.~        -  To study lack of response to steroid treatment in people with HES.~      Eligibility:~      Inclusion criteria:~        -  Individuals with hypereosinophilic syndrome with high eosinophil counts.~        -  Individuals who are willing to have blood drawn before and after getting steroids.~      Exclusion criteria:~        -  Individuals who are on more than 10mg of prednisone (or similar drug)~        -  Individuals with hypereosinophilic syndrome who are on other medications that could~          interfere with the study~        -  Women who are pregnant or breast-feeding~        -  Individuals who have a known gene mutation associated with chronic eosinophilic leukemia~        -  Children less than 18 years old who weigh less than 48kg or 106lb~      Design:~        -  Participants will have a screening visit with a physical exam and medical history. Blood~          and urine samples will be collected.~        -  Participants will have a single dose of the steroid prednisone by mouth in the morning.~          Blood samples will be collected 2, 4, 24 hours after this dose.~        -  On the day after the steroid dose, participants will provide another blood sample in the~          morning.~        -  Participants will start to take prednisone daily when they return home. Blood samples~          will be collected weekly at the participant s doctor s office. The dose of prednisone~          will be lowered depending on the weekly eosinophil count. We will try to get each person~          on the lowest dose of prednisone possible that will control the disorder. Participants~          who do not respond or have severe side effects will be taken off prednisone. Other~          treatments will be considered for people who do not respond to steroids. The goal is to~          evaluate the response to prednisone. Our research will try to figure out why some people~          do not respond to steroids. Most people will complete the study within 6 to 16 weeks,~          depending on their response to prednisone.~   "
155978|NCT01524523|"~     Background:~      - Many people feel pain during and after bone marrow aspiration (collection). Studies suggest~     that pain may be related to different kinds of inflammation, or the presence of nitric oxide~     (a normally occurring gas) in the body. Researchers want to study nitric oxide levels in the~     blood and breath before and after bone marrow collection. They will look at how these levels~     relate to feelings of pain.~      Objectives:~      - To better understand pain related to having a bone marrow collection.~      Eligibility:~      - Individuals at least 18 years of age who are enrolled in a study that requires bone marrow~     collection.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood sample.~        -  Participants will provide study blood and breath samples to check nitric oxide levels.~          Participants will also have a test to measure skin sensitivity to heat and touch.~        -  During the collection, participants will keep track of their pain levels.~        -  After the collection, participants will keep track of any pain medications they take.~          They will also record if and when they eat any foods that contain nitrates for about 24~          hours.~   "
155979|NCT01524510|"~     In this open prospective study 40 patients who received Mandibular Replacement Appliance~     (MRA) Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) will be~     included. The patient's sleep will be registered during 2 periods of 2 days: one while the~     patient does not wear the MRA and, +/- 1 week later, one while the patient wears the MRA.~     Furthermore, 2 low dose CT scans (one with and one without the MRA device in the mouth) will~     be taken. These data must allow the investigators to validate the use of functional imaging~     (segmentation and Computational Fluid Dynamics) as a predictor of the outcome of the MRA~     therapy in OSAHS patients.~   "
155980|NCT01524497|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to~     evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for~     treatment of depression in Chinese population.~   "
155981|NCT01524484|"~     Data on quality of clinical anesthesia are important for the improvement of both quality and~     patient safety in this field. Routine quality data are often collected by professionals busy~     with patient care. This study examines the reliability of routinely collected quality data by~     comparing the electronic anesthesia record with the respective reports on quality-indicating~     events, i.e. whether events during the anesthetic (e.g., drop of blood pressure, irregular~     heart rhythm, and others) were actually reported or not. Additionally, interviews with~     reporting staff (physicians and nurses) are performed to gain insight in possible obstacles~     to reporting during the working process.~   "
155982|NCT01524471|"~     Spastic esophageal motility disorders induced significant symptoms including dysphagia,~     retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel~     approach to perform myotomy through the esophagus with long submucosal tunnel. This study~     aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from~     animal study to clinical practice in human.~   "
155983|NCT01524458|"~     rimary spastic esophageal motility disorders, though uncommon, induce significant symptoms to~     patients including dysphagia, spastic chest pain, regurgitation as well as heartburn. The~     commonest causes of spastic esophageal motility disorders included Achalasia, hypertensive~     lower esophageal sphincter (LES), Nutcracker esophagus and Diffuse esophageal spasm (DES).~     Majority of these diseases were diagnosed by manometry. Achalasia is the most common primary~     esophageal motility disorder in which the LES failed to relax with increased pressure.~     Currently the standard treatment for Achalasia and spastic motility disorders is Laparoscopic~     Myotomy. The development of Natural Orifices Transluminal Endoscopic Surgery (N.O.T.E.S.) has~     lead to a new way to perform myotomy - Peroral Endoscopic Myotomy (P.O.E.M.). Basically,~     through mucosal incision, a submucosal tunnel is created after identification of the level of~     gastroesophageal junction. Myotomy will be performed with endoscopic instruments and the~     entrance site will be closed with clips.~   "
155984|NCT01524445|"~     The purpose of this retrospective study is to collect information about patients who received~     bortezomib as their first chemotherapy and who responded well to it, but who relapsed~     afterwards and were treated again with bortezomib a second time after a treatment-free period~     of at least 6 months. During this non-interventional study (this means that no drug is being~     tested in this study) the safety and effectiveness (whether it works or not) of bortezomib~     re-treatment will be evaluated in patients with multiple myeloma. Only data already mentioned~     in your clinical file will be collected. About 100 adult patients will take part in the study~   "
155985|NCT01524432|"~     This is a study of hygienic socks with antifungal agent-loaded microcapsules for subjects~     with interdigital type tinea pedis (athlete's foot between the toes). This is a 6 week study~     which has a 2 week treatment period and a 4 week follow-up evaluation.~   "
155986|NCT01524419|"~     1. Increased women's involvement in decision making at labor process correlates with a~          positive perception of the labor process.~        2. Increased maternal satisfaction with midwifery and gynecological care at labor~          correlates with a more positive perception of the labor process.~   "
155987|NCT01524406|"~     This is a safety and tolerability study investigating the effect of HPP593 in healthy~     volunteers during and after limb immobilization.~   "
155988|NCT01524393|"~     Occurrence of venous thromboembolism during in Vitro Fertilization (IVF) pregnancies has been~     reported in numerous case reports and in two small consecutive series. The incidence of~     venous thromboembolism (VTE) after IVF has been claimed to be comparable to the incidence of~     VTE during normal pregnancy. No information exists concerning pulmonary embolism (PE).~      The aim is to estimate and compare the risk of both PE and VTE during the the different~     phases of pregnancy after IVF to that in age and period matched control women. The~     investigators will use the Swedish National Health Registers to estimate the risk.~   "
155989|NCT01524380|"~     A double-blind, randomized, placebo-controlled trial of ginkgo biloba extract (Egb-761) as an~     add-on therapy to risperidone compared to risperidone plus placebo in the treatment of 200~     treatment-naive first-episode patients with schizophrenia. The study addresses an immune~     dysfunction hypothesis of schizophrenia.~   "
156126|NCT01522586|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.~   "
158885|NCT01486394|"~     The purpose of this study is to determine whether focused sonography of the heart, lungs and~     deep veins can increase the number of patients with respiratory symptoms correctly diagnosed~     in an emergency department.~   "
155990|NCT01524367|"~     Excitement during the emergence from general anesthesia is a great post-operative problem. It~     may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage,~     self-extubation, and removal of catheters, and it can necessitate physically or chemically~     restraining the patient. It has been reported that the incidence of postoperative emergence~     excitement in adults after general anesthesia is 21.3% occurrence.~      Many things are mentioned as risk factors for emergence excitement. Among them, excitement~     after orthognathic surgery (two-jaw) was more common than after other types of surgery. The~     patients undergoing emergence with nasotracheal intubation after orthognathic surgery may~     have a sense of suffocation during emergence from anesthesia, which may increase the~     incidence of emergence excitement.~      Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an~     S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1)~     compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.~      To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement~     was investigated only in children.~      The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence~     and the severity of the emergence excitement in adults with nasotracheal intubation after~     orthognathic surgery (two-jaw).~   "
155991|NCT01524354|"~     The aim of our study was to evaluate the significance of monitoring anesthetic depth for the~     conduct of anesthesia and the early postoperative period in patients subjected to surgical~     correction of combined valvular disorders.~   "
155992|NCT01524341|"~     This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria~     patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day~   "
155993|NCT01524328|"~     The purpose of this study is to investigate the proportion of use of complementary and~     alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). In addition,~     the reason for, and satisfaction with use of CAM.~   "
155994|NCT01524315|"~     The objective of this study is to determine whether preoperative parenteral thiamin~     supplementation does prevent the intra and early postoperative increase of lactate and~     whether this effect is related to the extent of thiamine deficiency in patients undergoing~     heart surgery. In addition the prevalence of major thiamin deficiency in patient undergoing~     heart surgery will be determined.~   "
155995|NCT01524302|"~     This study will further analyze the use of ceftaroline for CABP and compare its potential to~     eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of~     ceftaroline compared to levofloxacin may be further highlighted from this investigation.~   "
155996|NCT01524289|"~     The objective of this study is to evaluate the efficacy and tolerability of adding~     anacetrapib to ongoing statin therapy in participants with heterozygous familial~     hypercholesterolemia.~   "
155997|NCT01524276|"~     The purpose of the Registry is to provide continuing evaluation and periodic reporting of~     safety and effectiveness of Medtronic market-released products. The Registry data is intended~     to benefit and support interests of patients, hospitals, clinicians, regulatory bodies,~     payers, and industry by streamlining the clinical surveillance process and facilitating~     leading edge performance assessment via the least burdensome approach.~   "
155998|NCT01524250|"~     Patients aged 18-65 with acute demyelinating optic neuritis where treatment with high dose~     corticosteroids are already been chosen by the patient and the diagnosing physician will be~     contacted for screening and enrollment. Patients will then be randomized to receive~     equivalent doses of either intravenous (IV) or oral corticosteroid treatment. Optic nerve~     function assessments will be compared at baseline, prior to treatment, one and six months~     post corticosteroid treatment. This will allow for a comparison on whether the route of~     medication plays a role in the effectiveness of treatment with high dose corticosteroids.~   "
155999|NCT01524237|"~     This study will be comprised of 2 parts, Part A and Part B, both in healthy male~     participants.~      Part A of the study will investigate the safety of intravenous (IV) ketamine administration~     after single oral doses of LY2979165 (capsules) or LY2140023 (tablets). Part A will be~     completed before starting Part B.~      Part B of this study will investigate whether different dose levels of LY2979165 or~     LY2140023, when administered before ketamine, result in changes to the images on a brain scan~     seen with ketamine alone. Brain imaging is currently used for a number of reasons including~     understanding where in the brain medicines have their effects. Ketamine is an anesthetic used~     in this study to activate particular regions of the brain.~      The single oral doses of LY2979165 to be used in both parts of the study are 20 and 60 mg~     with matching dummy drug (placebo) for each dose.~      The doses for LY2140023 are 10, 40, and 160 mg with matching placebo for each dose.~      Screening is required within 28 days prior to the start of the study and follow up 7-14 days~     after the last dose of study drug. The study will last up to 8-weeks for an individual~     participant.~   "
156000|NCT01524224|"~     This study is a multicenter, open-label, dose-escalation phase 1 study of intravenous (IV)~     LY2495655 in participants with advanced cancer.~   "
156001|NCT01524211|"~     The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular~     stent-graft system for the treatment of aortic aneurysms.~   "
156008|NCT01524120|"~     Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders,~     Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and~     histologic features including patterns of inflammation, crypt abscesses and granulomas.~     Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for~     gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an optical biopsy~     of the gastrointestinal mucosa during the endoscopic procedure.~      The main objective of this study is to determine endoscopic and endomicroscopic features of~     mucosal healing in patients with IBD.~   "
156009|NCT01524107|"~     The medical literature does not provide sufficient information or recommendation regarding~     specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to~     compare maternal and neonatal morbidity of women who have undergone urgent Caesarian Sections~     for Prolapsed Cord to those who have undergone Elective Caesarian Sections in order to~     develop a standard treatment protocol. The Medical Record review will include many parameters~     including complications, type of antibiotic usage etc.~   "
158886|NCT01486381|"~     This trial is conducted in South Africa. The aim of this trial is to investigate Long term~     safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in~     trial BIAsp-1240.~   "
156002|NCT01524198|"~     Asthma is the most common chronic illness of childhood. About 10% of children are affected.~     Not surprisingly, acute asthma exacerbations are one of the common reasons to visit pediatric~     emergency rooms (ER). About 5.7% of all pediatric emergency room visits are due to acute~     asthma exacerbation. Around 8% of those get admitted to the hospital. This constitutes huge~     financial and administrative burden on the health care system.~      Inhaled corticosteroids (ICS) is the gold standard prophylactic therapy for patients with~     persistent asthma. In the setting of acute asthma exacerbation systemic steroids given early~     in the course of treatment help decrease the rate of admission and return to the ER. However,~     the anti-inflammatory action of corticosteroids, through which this effect is caused, takes 4~     hours to start working. This is because it is mediated through genomic pathways where the~     transcription of several inflammatory cytokines is suppressed. It was also shown that~     corticosteroids can cause vasoconstriction through non-genomic pathways. The onset of this~     action is as quick as 30-60 minutes. It is proposed that this action is mediated by blocking~     the extraneuronal uptake (metabolism) of norepinephrine in vascular smooth muscle cells,~     hence, making it available for re-use by the sympathetic neuronal cells.~      Our objective is to compare the efficacy of adding repetitive sequential doses of budesonide~     versus placebo (normal saline (NS)) to β2-agonist and ipratropium bromide (IB) combination~     (standard treatment) in the management of acute asthma in children in the ER. We hypothesize~     that the addition of budesonide to β2-agonist and IB in the management of moderate to severe~     acute asthma in the ER is superior to the addition of placebo.~   "
156003|NCT01524185|"~     Children who have been exposed to trauma (defined as physical, sexual or emotional abuse,~     neglect, exposure to life threatening events, domestic and community violence, parental~     mental health disorders, substance abuse, and/or incarceration may also have parents who have~     experienced trauma. Often, unresolved intergenerational trauma makes treatment of children~     with trauma and its sequelae, including Post Traumatic Stress Disorder, attachment disorders~     and dysregulation characterized by emotional lability, hyperarousal, and sleep and attention~     disturbances, difficult to manage. FamilyLive (FL) is a promising treatment approach~     developed by clinicians at the Kennedy Krieger Family Center (KKFC) over 10 years ago to~     address the unique needs of families with unresolved and untreated histories of neglect and~     disrupted attachment who need support to build skills for managing their children's responses~     and behaviors. FL uses a team approach with a therapist in the room with the family and~     call-in observations and clinical suggests from a clinician behind a one-way mirror. Through~     the call-in process the treatment team provides validation, acknowledgement, support and~     multiple perspectives for the family's experiences. The FL approach works with families to~     improve parental self-care, stress management, emotional regulation and self-awareness.~      Despite its clinical use at the KKFC, the effectiveness of the FL intervention not been~     systematically evaluated using a randomized design. The proposed preliminary study will use a~     randomized design to evaluate the feasibility of conducting a larger randomized trial of FL~     compared to other standard mental health care treatments (SMHC) at the KKFC. We hypothesize~     that it will be feasible to recruit sufficient numbers of clients for and conduct a~     randomized controlled trial of FL on a cohort of children exposed to neglect and trauma. We~     also hypothesize that FL participants will evidence greater reductions in heart rate~     variability, behavior problems, trauma symptoms, and improvements in functioning compared to~     participants in the SMHC.~   "
156004|NCT01524172|"~     This preliminary study will examine the feasibility of conducting a randomized clinical trial~     of Yoga Based Psychotherapy (YBPG) and standard care mental health (SCMH) treatment compared~     to SCMH for children ages 8-12 years who have a history of neglect and maltreatment (trauma).~     The goal of the study is to inform the method and sample size for a larger randomized trial~     to study the effect of YMBT with SCMH compared to SCMH in improving child regulation of~     behavior, emotions, and daily functioning. Children who have experienced trauma, including~     sexual abuse, physical abuse, emotional abuse, exposure to community or domestic violence,~     parental substance abuse, mental health disorders, and incarceration are at risk to have~     dysregulation of mood, emotions and behavior. In addition, children exposed to neglect and~     trauma may have poor attachment to caregivers and poor peer relations. It is hypothesized the~     using YBPG as an adjunct to SCMH may improve children's regulation of emotion and behavior.~   "
156005|NCT01524159|"~     The purpose of the study is to evaluate the effect of dietary supplementation of bromelain (a~     proteolytic enzyme from the pineapple plant) on the reduction of plasma fibrinogen level~     among type 2 diabetic subjects who have a high risk of cardiovascular disease.~      The null hypothesis [Ho] is: there is no significant improvement in plasma fibrinogen, serum~     lipid profile, blood pressure, BMI, waist circumference and C-reactive protein for subjects~     with type 2 diabetes who are at risk of CVD following the intervention of bromelain~     supplementation compared to placebo group.~      The alternative hypothesis [H1] is: there is a significant improvement in plasma fibrinogen,~     serum lipid profile, blood pressure, BMI, waist circumference and C-reactive protein for~     subjects with type 2 diabetes who are at risk of CVD following the intervention of bromelain~     supplementation compared to placebo group.~   "
156006|NCT01524146|"~     Currently, very few centers offer Photodynamic therapy for unresectable Cholangiocarcinoma in~     the United States. Several European studies have reported the efficacy and safety of~     Photodynamic Therapy (PDT) for Cholangiocarcinoma, however, only a few studies have reported~     the same in the United States.~      The establishment of a registry to capture all PDT cases within and outside US can help the~     investigators evaluate a larger and non-ambiguous sample population. This would help the~     investigators evaluate the technical success rates, clinical success rates, feasibility and~     safety of PDT for unresectable cholangiocarcinoma. With more endoscopists considering PDT as~     a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need to~     further evaluate the efficacy and safety of such combined procedures as well. The ultimate~     objective is to assess if PDT with or without additional or adjuvant treatment options~     prolongs survival duration and improves quality of life in patients with unresectable~     cholangiocarcinoma.~      This multicenter registry has been initiated:~        -  To document the impact of PDT on the clinical management of unresectable~          cholangiocarcinoma.~        -  To assess the clinical and technical success rates of PDT for unresectable~          cholangiocarcinoma.~   "
156007|NCT01524133|"~     The current research study aims to compare the effectiveness of two proven treatments for~     posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their~     combination. In addition, the investigators are examining predictors of response to these two~     treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such~     treatments. Biological mechanisms of change are also examined including emotion processing~     and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the~     investigators will examine acceptability of each treatment and reasons for ending treatment.~   "
158912|NCT01486043|"~     The purpose of this study is to determine whether metformin is an effective adjunctive~     treatment for transient hyperglycemia in patients with acute lymphoblastic leukemia (ALL)~     undergoing induction chemotherapy~   "
156011|NCT01524081|"~     Aim of prospective randomized a placebo controlled study is to prove that in case of acute~     surgical procedure due to appendicitis, ileus of small bowel and perforation of small bowel~     and stomach appropriately administered antibiotic prophylaxis is effective with lower~     incidence of infection in surgical site and comparable risk of development of other~     nosocomial infections versus group without antibiotic prophylaxis. Secondary aim is to~     determine risk of developing nosocomial infection in the above mentioned group of patients,~     identify group of patients which does not benefit from prophylaxis, and compile financial~     costs for antibiotic prophylaxis and treatment of nosocomial infections and thus the~     background for the recommended procedure with regards that such prospective study does not~     exist in the Czech Republic.~   "
156012|NCT01524068|"~     This is a randomized, multi-center, open-label Phase II clinical trial to determine the~     efficacy of combined plasma exchange (PEX), rituximab, and conventional corticosteroid~     administration, in comparison to corticosteroids alone, among patients with acute Idiopathic~     Pulmonary Fibrosis (IPF) exacerbations.~      The investigators central hypothesis is that antibody-mediated autoimmunity can play an~     important role in IPF exacerbations. The investigators propose to test our central hypothesis~     by establishing the efficacy of autoantibody removal by plasma exchange (PEX), in conjunction~     with B-cell depletion by rituximab to deplete immunoglobulins and minimize their further~     production, among patients with acute IPF exacerbations.~      The primary goal of this randomized, multi-center, open-label Phase II clinical trial is to~     determine effects of combined plasma exchange (PEX), rituximab, and conventional~     corticosteroid administration on selected, relevant immunological parameters, in comparison~     to effects of steroids alone, among AE-IPF patients. The investigators anticipate the~     findings of this will lead to larger incremental trial(s) to determine actual clinical~     efficacy of this treatment.~      A total of 40 subjects will be enrolled in this multi-center trial from 5 participating~     medical centers.~   "
156013|NCT01524055|"~     Double-balloon enteroscopy (DBE) was introduced 2001 for visualizing the entire small bowel.~     In 2008, a novel balloon-assisted enteroscope system has been developed using only a single~     balloon (single-balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and~     treatment of the small bowel. The investigators could demonstrate the both endoscopic~     procedures are equally suitable in the clinical routine. In both balloon-assisted endoscopic~     procedures (balloon-assisted enteroscopy (BAE)) it is mandatory to insufflate gas into the~     bowel to secure good visualization. All endoscopes used for GI endoscopy provide a gas~     insufflation unit. Currently, many endoscopy units use air for this purpose. The use of air,~     however, is far from ideal for insufflation in GI endoscopy. During and after GI endoscopy,~     significant amounts of air are usually retained in the bowel segment inspected. This air has~     to pass the GI tract and exit physiologically through the rectum. Thus, abdominal pain and~     discomfort during and after the examination due to the retention of air have been shown to be~     very common during and after endoscopic procedures. Carbon dioxide gas (CO2), unlike air, is~     rapidly absorbed from the bowel. Within minutes, several liters of CO2 can be absorbed from~     the GI tract. The use of CO2 has been shown to result in more comfortable examinations in~     both colonoscopy and flexible sigmoidoscopy in several randomized trials. In these studies,~     CO2 insufflation had almost completely reduced procedure-related pain and discomfort.~      In 2007, the investigators could demonstrate the advantages of CO2-Insufflation in DBE.~     Another group confirmed our findings. To our knowledge, no study has been performed~     investigating the use of CO2 in SBE.~      The aim of the present study is to examine whether CO2 insufflation leads to a reduction of~     abdominal pain in SBE patients. Furthermore, the investigators want to investigate if CO2~     insufflation facilities a deeper intubation of the endoscope, as shown for the DBE technique.~   "
156014|NCT01524042|"~     Recently colonoscopy has gained importance as screening programs for colon polyp, cancer and~     inflammatory bowel disease in the United States and other countries. The number of~     colonoscopy performed has been increased year by year. To make an increased compliance with~     colonoscopy in both screening and clinical surveillance programs, consideration of anxiety,~     shame and satisfaction in examinee is regarded to be important. During colonoscopy patients~     wear conventional single pants where there is no hole for insertion of scope. Patients take~     off the conventional single pants below the buttocks and expose their buttocks and perianal~     area during colonoscopy. Exposing perianal and perineal area during colonoscopy can make~     patients feel shameful and anxious and diminish satisfaction of colonoscopy. Recently~     considering the factors affecting satisfaction has been regarded to be important because~     patient satisfaction could be one of the quality indicators for colonoscopy. To diminish~     shame and anxiety by exposing perianal and perineal area of patients wearing conventional~     single pants during colonoscopy, we developed novel double pants with a hole in inner pants.~     Novel double pants are composed of double fabrics from hip to thigh and single fabric under~     the thigh such as common pants. In the inner pants of double pants, there is a hole for~     insertion of scope. The hole is 25 cm wide and 15 cm long. The outer pants are same as~     conventional single pants. If the patients dropped outer pants below hips, only hip and~     perianal area are exposed through the hole (25cm*15 cm) for insertion of scope without~     dropping inner pants. Therefore novel double pants minimized the exposed area of hips than~     conventional single pants because hips are exposed only the hole of inner pants. Smaller~     exposed area of hips by novel double pants can minimized the shame and anxiety by diminishing~     exposing perianal and perineal area during colonoscopy. Therefore advantage of novel double~     pants is decreasing shame and anxiety and increasing satisfaction by minimizing the exposed~     area of perianal and perineal area compared with conventional single pants. This study is a~     randomized controlled study. The investigators will survey the examinees older than 20 years~     who performed the colonoscopy at Severance Hospital from Feb. 2012 to Jul. 2012 to compare~     the effect on the satisfaction, shame, and anxiety during colonoscopy between the two groups.~   "
156015|NCT01524029|"~     The goal of this study is to determine the value of the new mammography technique called~     Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital~     Mammography for the early detection of Breast Cancer.~      DBT is able to compute a three-dimensional image of a breast from several low-dose~     mammographies taken from different angles while the device is moving around the breast in a~     circular motion. This should overcome a significant limitation of Digital Mammography arising~     from the masking of breast cancer in a mammography image caused by overlying normal breast~     tissue.~      This is a study conducted in several Austrian Breast Imaging Centers.~   "
156016|NCT01524016|"~     Oncogenic osteomalacia is rare disease predominantly caused by a small, somatostatin receptor~     positive mesenchymal tumor, which is frequently hidden in an unusual anatomical site and~     often goes undetected by conventional imaging. A permanent cure of the disease relies on~     exactly localizing the tumor and completely removing it. 68Ga-DOTATATE PET/CT is a novel scan~     that might have improved sensitivity and resolution specifically for somatostatin receptor~     positive tumors. The investigators will scan the suspicious and confirmed patients of~     oncogenic osteomalacia and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT to see~     if it improves patient care.~   "
156017|NCT01524003|"~     The purpose of this study is to develop and implement a community based preventive healthcare~     model using cervical cancer screening as the target medical intervention.~      The investigators will first conduct 2 pilot studies to refine their preventive healthcare~     model based on the principles of community based participatory research (1000 participants).~     The investigators will then apply the model to screen 9000 women for cervical cancer over a~     period of 7-9 days. This 10,000 patient trial will explore the ability of a community to~     conduct their own screening program to identify who needs medical intervention based on~     self-collection and centralized high-throughput low cost human papillomavirus (HPV) testing.~   "
156018|NCT01523990|"~     A Safety Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in HCV Genotype 1~     Infected Patients~   "
156138|NCT01522430|"~     The DEPART study end points are to provide conclusive evidence, using a randomized, double~     blinded, sham procedure controlled study design, that radiofrequency renal denervation:~        1. reduces daytime ambulatory blood pressure,~        2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.~   "
156019|NCT01523977|"~     Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent~     tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus~     is approved for use in the United States for certain types of cancer, such as kidney cancer.~     It has been extensively studied in people with various types of cancer as a single agent (a~     drug that is used alone to treat the cancer) or in combination with a number of other drugs.~     Studies in adults with cancer have also evaluated Everolimus in combination with other~     anti-tumor drugs. Information from lab studies and some other clinical trials suggests that~     Everolimus may kill leukemia cells on its own, and also make it more likely that steroids~     (such as prednisone) are able to kill leukemia cells.~      In this research study, we are looking to learn more about how Everolimus works in~     combination with other drugs which are commonly used to treat relapsed acute lymphoblastic~     leukemia (prednisone, vincristine, PEG-asparaginase, and doxorubicin). The main goal of the~     study is to evaluate the side effects of this treatment combination in order to determine a~     safe dose of Everolimus which can be given with these other 4 drugs.~   "
156020|NCT01523964|"~     Physicians seek a method to assess neuromuscular disease that is both non-invasive and~     quantifiable. Many patients do not tolerate standard current day assessment tools (such as~     needle electromyogram), and Electrical Impedance Myography (EIM) has the potential to serve~     as a non-invasive, quantifiable, diagnostic tool for neuromuscular disease. If successful,~     these devices will allow for improved ability to diagnose neuromuscular disease and to assess~     disease progression or remission, allowing for better care of individual patients as well as~     for use in clinical trials, where improved outcome measures for neuromuscular diseases is~     being sought.~   "
156021|NCT01523951|"~     Aim of the study is to demonstrate superiority of a continuous cooling of the skin over~     topical EMLA or placebo in reducing the burning pain during the application of capsaicin 8%~     patch (Qutenza).~      Secondary it will be tested, if the 2 different pre-treatments have an effect on the~     application pain within the first 24 hours, and if different pre-treatments have an effect on~     the reduction of the epidermal nerve fiber density (ENFD) 1 week after Qutenza application.~   "
156022|NCT01523938|"~     The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac~     or spinal column surgery. A particular aim is to point out the effects on postoperative~     cognitive outcome. Additional blood and urine tests are conducted (concerning cardiac~     stratum).~   "
156023|NCT01523925|"~     This project attempts to perform a randomized controlled trial to verify the efficacy and~     motor control mechanism of the proposed combined functional electrical therapy with~     distributed constraint-induced therapy or with robot-assisted Bilateral training.~   "
156024|NCT01523912|"~     The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the~     follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the~     last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment~     of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied.~     The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment~     of dysplastic gastric mucosa.~   "
156025|NCT01523899|"~     This study expands upon pilot data for feasibility since May 2011. The study aims to evaluate~     the effect of rapid test availability on use of targeted spectrum antibiotics for non-MRSA~     abscesses in ambulatory patients in the Emergency Department (ED). The multi-institutional~     study will assess the feasibility of providing the GeneXpert® MRSA/SA SSTI assay to the ED~     and evaluate the impact of delivering the test result to clinicians in real-time on patient~     management decisions regarding the use of antimicrobial agents. Patients are randomized to~     standard culture (control arm) or to the GeneXpert® assay plus standard culture.~   "
156026|NCT01523886|"~     The purpose of this investigation is to compare the surgical conditions during laparoscopic~     cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.~      The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are~     better with deep muscle relaxation than moderate muscle relaxation.~   "
156027|NCT01523873|"~     The main purpose of this study is to prospectively assess the general safety profile of~     Dotarem~   "
156028|NCT01523860|"~     This is a prospective, multicenter phase II trial designed to determine efficacy and safety~     of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine + Mitoxantrone~     in elderly patients with advanced stage Follicular Lymphoma.~   "
156029|NCT01523847|"~     The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the~     cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is~     substituted for doxorubicin in the conventional ABVD regimen.~   "
156030|NCT01523834|"~     Treatment of adult patients with Diffuse Large B-cell Lymphoma (DLBCL), relapsed or~     refractory to previous CHOP-R (or CHOP-R like regimen) front line therapy, relapsed or~     refractory to second or subsequent salvage therapies which included high dose therapy with~     autologous stem cell support (ASCT).~      Treatment of adult patients with DLBCL relapsed or refractory to front line therapy with~     CHOP-R (or CHOP-R like regimen) or subsequent treatments, who are not consider eligible for~     ASCT consolidation because of age, co-morbidities, impossibility to perform ASCT.~      The trial is conducted according to the optimal two-stage design of Simon with alpha 0.05 and~     beta 0.10, considering the following two hypotheses: first a response rate (RR) less than 10%~     is of no further interest; and second, an RR 30% is clinically meaningful. In the initial~     stage, 18 patients have to enter onto the study. If less than 3 responses (</=2 in 18) will~     be observed, the trial would be terminated. Otherwise, accrual will continue to a total of a~     maximum of 35 patients. At the end of the trial, if 6 or fewer responses will occur among the~     35 patients (</= 6 in 35), it will be concluded that the regimen is not worthy of further~     investigations for that group of patients.~      The treatment is divided in three phases: induction phase (course 1 to 6), consolidation~     phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any~     reason).~   "
156031|NCT01523821|"~     This phase I/II trial studies the side effects and best dose of alpha 1 anti-trypsin~     (alpha-1-proteinase inhibitor human) and to see how well it works in treating patients with~     acute graft-versus-host disease (GVHD). Alpha-1-proteinase inhibitor human may be a better~     treatment for graft-versus-host disease caused by a stem cell transplant.~   "
192330|NCT01046864|"~     The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when~     combined with standard dose 5FU/LV and FOLFIRI.~   "
156032|NCT01523808|"~     The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo~     studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly,~     these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA~     is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I~     clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced~     or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy~     using gemcitabine.~   "
156033|NCT01523795|"~     The purpose of this study is to determine whether playing motion-controlled video games~     produces low caloric intake and higher caloric expenditure than watching TV or playing~     traditional video games.~   "
156034|NCT01523782|"~     There is not clinical validation that the benefits of L-asparaginase can offers during~     induction chemotherapy for elderly patients, where prevent toxicities is critical.This Phase~     IIa clinical trial propose to evaluate, specifically for elderly patients, the tolerated dose~     of GRASPA® in combination with a poly chemotherapy treatment which enables efficient~     L-asparagine depletion for a period at least equal to 7 days.~   "
156035|NCT01523769|"~     Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these~     infants have higher circulating blood volume in the first 24 hours, less need for blood~     transfusions, and less incidence of intraventricular hemorrhage. Delayed umbilical cord~     clamping has also been shown to increase the initial hematocrit and decrease the need for red~     blood cell (RBC) transfusions compared with no intervention in infants born between 27 and 33~     weeks' gestation. However, a delay in cord clamping of 30-45 seconds may theoretically~     interfere with neonatal resuscitation. There have been few studies that addressed the active~     milking of the cord and its effect on neonatal resuscitation. Active milking of the umbilical~     cord towards the baby prior to clamping (rather than passive) should take less than 5 seconds~     to perform and should not interfere with neonatal resuscitation. Umbilical cord milking, as~     an alternative to delayed cord clamping, has been shown to increase the circulatory blood~     volume expressed as the hemoglobin value. Active milking of the cord prior to clamping,~     however, is not considered standard of care and only 1 Japanese randomized control study has~     reported that umbilical cord milking reduces the need for RBC transfusions, thus reducing the~     number of infants requiring a RBC transfusion as compared with control conditions. Our study~     aims to test the hypothesis that active milking of the umbilical cord will reduce the need~     for transfusion in preterm infants.~   "
156036|NCT01523756|"~     This is an open-labelled randomized cross-over and controlled exploratory intervention that~     aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy~     appliances each for two weeks. During the test a questionaire is to be filled out and~     interviews will take place. Primary parameter is leakage. A Study nurse will visit the~     participants in their homes every two week during the test.~   "
156037|NCT01523743|"~     The purpose of this study is to compare compact intermittent catheters with standard coated~     intermittent catheters with regard to quality of life, using the Intermittent~     Self-Catheterisation Quality of life Measure.~   "
156038|NCT01523730|"~     Cigarette smoking rates are extremely high in persons with schizophrenia and this increases~     the risk of disease and death due to tobacco-related disorders. One of the features of~     schizophrenia is reduced cognitive abilities, such as poor attention and memory. It is~     thought that people with schizophrenia smoke cigarettes to reduce these cognitive problems,~     as nicotine can improve cognitive function in these people. When people with schizophrenia~     stop smoking it causes further cognitive difficulties, which makes quitting harder for them~     compared to people without schizophrenia. A method called repetitive transcranial magnetic~     stimulation (rTMS) allows clinicians to give repeated magnetic pulses through the scalp to~     cause changes in brain activity and behaviour. rTMS can improve cognitive function in people~     with schizophrenia. Studies have also shown that rTMS can reduce tobacco craving and~     consumption of cigarettes. Therefore, we believe that rTMS will improve the cognitive~     deficits observed during cigarette smoking abstinence and help reduce cravings for~     cigarettes. Ultimately, rTMS may help smokers with schizophrenia who can't quit smoking with~     available treatments. This study will examine the effect of rTMS on tobacco cravings and~     cognitive problems produced by overnight abstinence from cigarette smoking in persons with~     schizophrenia in comparison to people without mental illness who smoke. Important information~     about the potential of rTMS for the treatment of cognitive deficits and tobacco addiction in~     schizophrenia will be obtained. Providing more effective smoking cessation treatments in~     people with schizophrenia may lead to improved physical and mental health for these patients,~     who are extremely susceptible to tobacco addiction and tobacco-related illness.~   "
156039|NCT01523717|"~     The purpose of this study is to investigate the relationship between a procalcitonin decrease~     over 72 hours and outcome in patients who have severe sepsis or septic shock.~   "
156040|NCT01523704|"~     The number of patients with implantable pulse generator (IPG) has steadily increased in Japan~     causing increment in number of in office follow-ups and greater burden on many hospitals.~      The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home~     Monitoring system reduces office follow-up visits without compromising patient safety.~      Patients will be randomized into HM follow-up only (Group 1) or HM & in-office follow-up~     (Group 2) and will be followed-up for 27 months.~   "
156041|NCT01523691|"~     Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient~     sleep increases susceptibility to a variety of disease states by progressively compromising~     the integrity of stress response systems.~   "
156063|NCT01523405|"~     This is a non-interventional, cross sectional, multicentric study in T2DM patients which will~     involve a single visit for study related procedures. This study will be conducted in~     approximately 5,000 patients at around 300 hospitals/primary care clinics across India.~     Approximately 18-20 patients per site will be enrolled. This study has been designed to~     evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in~     relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM~     patients on oral / injectable anti-diabetic drugs with/without insulin therapy.~   "
156064|NCT01523392|"~     The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African~     American patients with stable coronary artery disease.~   "
194840|NCT01013116|"~     The objective of this study is to evaluate the efficacy and safety of specific subcutaneous~     immunotherapy with modified allergen extracts.~   "
156042|NCT01523678|"~     Rationale: The administration of prophylactic G-CSF may reduce the toxicity of a weekly~     paclitaxel/carboplatin regimen in gynaecological cancers.~      Purpose: This multicenter phase II trial is studying the side effects of weekly~     paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent~     epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or~     cervical carcinoma. Data obtained in this trial will be compared with historical data as~     published earlier.~      The trial will include 3 cohorts of 36 patients:~        -  Subjects with ovarian, fallopian tube or peritoneal carcinoma~        -  Subjects with endometrial cancer~        -  Subjects with cervical carcinoma~      Treatment:~      Subjects will receive Paclitaxel 60 mg/m² followed by Carboplatin AUC 2.7 intravenously~     weekly during 18 weeks. Filgrastim (Neupogen) will be given to all patients on day 5 and~     possibly on day 6 of each course. Subjects will be evaluated by CT/MRI scan after 9 cycles of~     chemotherapy (week 10), after 18 cycles of chemotherapy, then every 6 months for the next 2~     years and then if clinically indicated. Subjects who develop disease progression will~     discontinue therapy. Subjects who have no evidence of disease progression after completion of~     study therapy will be followed until disease progression, withdrawal of informed consent, or~     death.~   "
156043|NCT01523665|"~     Glucose metabolism is impaired in many critically ill patients and is often aggravated by~     parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion~     protocols, which are based on frequent bedside glucose monitoring, have been implemented on~     most critical care units. Despite extensive efforts of the intensive care unit staff~     difficulties were experienced in achieving efficient and safe glucose control. Several~     barriers to the implementation of glycemic control have been identified. Most importantly,~     there is concern about increased frequency of severe hypoglycemic episodes. To overcome these~     problems Space GlucoseControl was developed as a decision support system which helps to~     achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or~     4.4 - 8.3 mmol/l).~      The objective of this non-interventional study is to gain additional information on the~     performance of the Space GlucoseControl system for glycaemic control in ICU patients when~     used in routine clinical practice.~   "
156044|NCT01523652|"~     The purpose of this study is to determine whether HGF serum concentration might be raised in~     vivo by administering nadroparin given with prophylactic purpose to gynecological patients.~   "
156045|NCT01523639|"~     This multicenter randomized, placebo-controlled phase II study will enroll 132 first-line~     palliative treated subjects with metastatic KRAS wild type CRC. Subjects with histologically~     confirmed, KRAS wild-type CRC without previous chemo-therapy for metastatic disease will be~     screened for this study.~      Approximately 10 sites in Austria will participate in the study. Subjects will be randomized~     in a ratio of 1:1 into two groups.~   "
156046|NCT01523626|"~     Computed tomography (CT) scanning has become essential in the early diagnostic phase of~     trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT~     scanners and infrastructural improvements made 'total body' CT scanning (TBCT) technically~     feasible and its usage is currently becoming common practice in several trauma centers.~      However, literature provides limited evidence whether immediate 'total body' CT scanning~     leads to better clinical outcome then conventional radiographic imaging supplemented with~     selective CT scanning in trauma patients. The aim of the REACT-2 trial is to determine the~     value of immediate TBCT scanning in trauma patients.~      The investigators hypothesize that immediate 'total body' CT scanning during the primary~     survey of severely injured trauma patients has positive effects on patient outcome compared~     with standard conventional ATLS based radiological imaging supplemented with selective CT~     scanning.~   "
156047|NCT01523613|"~     The purpose of this study is to extend our knowledge concerning the clinical performance of~     two dental filling materials in molars. The study will compare two high-strength~     glass-ionomer filling materials.~      The investigators hypothesize that after two years (1) the clinical performance of both~     filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar~     or higher incidence of fracture than Fuji IX GP fillings.~   "
156048|NCT01523600|"~     The purpose of this randomised (double-blind) controlled exercise intervention trial is to~     determine whether the whole body vibration (WBV) training can effectively improve physical~     functioning of older people living in or regularly using services of sheltered housing,~     reduce their fear of falling, and prevent falling. The study comprises a 10-week training~     period and a 10-month follow-up period.~   "
156049|NCT01523587|"~     This randomised, open-label phase III trial will be performed in patients with advanced~     squamous cell carcinoma of the lung requiring second-line treatment after receiving~     first-line platinum-based chemotherapy. The primary objective of this trial is to compare the~     efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.~   "
156050|NCT01523574|"~     Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part~     of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. One~     of the most important limitations to its use is the induction of both acute and chronic~     peripheral neuropathy (PN). Previous studies have shown that vitamin E can reduce the~     incidence of cisplatin-induced PN by 50%. In this study, the investigators aimed to determine~     if vitamin E could also prevent Ox-induced acute PN~   "
156051|NCT01523561|"~     The aim of this study is to evaluate if creative dance twice weekly can influence girls~     wellbeing. The focus lies on girls 13-18 years old that suffer from repeatedly psychosomatic~     problems and/or stress.~      Specific objectives are~        -  To assess the effect of the dance intervention in reducing psychosomatic problems (such~          as pain in the head, neck, shoulder or stomach), stress and depression~        -  Determine which factors are important for continuing dancing and keeping up new habits~        -  A cost-effectiveness analyse of the health outcome.~      Geographical area: Örebro County (population 276,000)~   "
156065|NCT01523379|"~     The complex regional pain syndrom is a weighty disease that often results in a lifelong~     disability. Mostly this disease appears unilateral after comparatively mundane fractures or~     operations. In early stages CRPS shows inflammatory processes. These inflammatory components~     can be seen as edema and vasodilatation. These inflammatory processes lead us to the~     hypothesis that selective COX-2-inhibitors might help patients with CRPS.~   "
156066|NCT01523366|"~     The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic~     patients with stable coronary artery disease.~   "
156052|NCT01523548|"~     The purpose of this study is to examine the potential of carbon monoxide (CO) to decrease~     elevated blood pressure in the pulmonary artery. This symptom is seen in patients with~     pulmonary arterial hypertension, a rare disease that causes fatigue, dizziness, and shortness~     of breath because the blood vessels that supply the lungs narrow, forcing the heart to work~     harder to push blood through. Previous studies in the laboratory have shown that carbon~     monoxide has promise in treating these symptoms.~      Subjects in this study are being asked to undergo a new type of treatment to improve~     pulmonary arterial hypertension by breathing CO gas. CO is a colorless, tasteless, odorless~     gas usually found in car exhaust or cigarette smoke. It is administered with a continuous~     flow of air. Subjects will undergo a screening process during which it will be determined if~     they are eligible for the study. After the screening process, if subjects meet eligibility~     criteria for the study, they will begin carbon monoxide treatment through a cushioned mask~     that is placed over the nose and mouth. This treatment will last for sixteen weeks.~   "
156053|NCT01523535|"~     The 24-hour-a-day, 7-day a week, work-world arrived within our lifetimes, and is here to~     stay. Americans are working more and more, frequently at multiple jobs. The pattern of short~     sleep during the week followed by attempts to recover on the weekend is in common practice,~     but we know little of the associated health risks. What is the cost in terms of increasing~     known risk markers for cardiovascular disease, of repeated nights of insufficient sleep, and~     is this cost compounded with repetition, without adequate recovery? Evidence is accumulating~     to suggest that short sleep duration is linked to the development of metabolic and~     inflammation-associated diseases, such as cardiovascular disease. Mechanisms involved in the~     development of cardiovascular disease include impaired vascular function and inflammation.~     The current proposal is designed to investigate the effects of repeated periods of short~     nocturnal sleep duration in 4 cycles (each cycle consisting of 3 nights of 4 hours of sleep~     opportunity per night), and each cycle of short sleep followed by a single night of recovery~     sleep. Vascular reactivity will be assessed using brachial artery flow mediated dilation, and~     microcirculatory vasodilation will be assessed using perfusion imaging techniques. The~     dependence of IL-6 and sVCAM-1 as measured in peripheral circulation, on vascular function,~     will also be investigated.~   "
156054|NCT01523522|"~     This project aims to offer autologous muscle-derived progenitor cell injection as an~     efficient mini-invasive surgical therapy that would be simple for the patient and could be~     used in a majority of cases, including in young women in the post-partum. This approach may~     provide efficient tissue repair of the striated anal sphincter which is not permitted by~     existing therapies. This innovative therapy may ultimately be proposed after failure of the~     common treatments and before an high-risk invasive surgical intervention. Besides, injection~     of muscle-derived progenitor cells in animals has shown very encouraging results of the~     sphincter function assessed ex vivo. Hence, a high benefit may be expected with this~     approach.~   "
156055|NCT01523509|"~     The proposed test is intended to enable dentists to differentiate between cavitated and~     non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces).~     In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays~     (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low~     sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns,~     pain, root canals, and possible later loss of teeth.~      Hypothesis: Use of radiographic contrast on teeth will increase the accuracy of detection of~     early cavitation from 58% to 90%.~   "
156056|NCT01523496|"~     The purpose of this study is to determine the correct dose of Vitamin D to give to prevent~     HIV related complications.~   "
156057|NCT01523483|"~     The investigators study objective is to investigate the effectiveness of vaginal micronized~     progesterone in prolonging pregnancy after an episode of preterm labor which responded to~     tocolytic treatment. Furthermore, the investigators aim is to study the mechanisms of actions~     of progesterone supplementation by examining its effect on the two components of parturition:~     cervical ripening and myometrial contractility. The investigators will utilize transvaginal~     ultrasound to assess the changes in the cervical tissue, and non-invasive trans-abdominal~     uterine EMG to assess the uterine muscle activity. The investigators will also look at the~     effect of progesterone on contraction frequency by tocodynamometer (TOCO), though EMG is~     expected to provide much more information.~   "
156058|NCT01523470|"~     The investigators design a pilot randomised, single-centred, controlled trial to compare~     different withdrawal methods of Non-invasive ventilation. Our study aims at comparing~     stepwise withdrawal of Non-invasive ventilation versus immediate withdrawal of Non-invasive~     ventilation. The primary endpoint is to compare the rate of success between two withdrawal~     methods. The investigators define success as no recurrence of acute hypercapnic respiratory~     failure or restitution of Non-invasive ventilation within 48 hours after NIV is stopped. The~     secondary endpoints include time to recurrence of acute hypercapnic respiratory failure~     measured from the time of randomisation, the total days of Non-invasive ventilation use and~     the days of hospitalisation. Results from this trial will inform design of future randomised~     trial in this area.~   "
156059|NCT01523457|"~     The primary objective of this study was to determine the progression free survival in~     patients with metastatic pancreatic cancer and in patients with locally advanced unresectable~     non-metastatic pancreatic cancer treated with a dose-attenuated modification of folinic acid,~     fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints included:~     determine objective response rate according to RECIST; determine overall survival; evaluate~     toxicity; determine rate of resection in locally advanced unresectable stratum; correlate~     time to progression, objective response, and overall survival with early changes in glucose~     metabolism using [18F]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning.~   "
156060|NCT01523444|"~     This proposed study tests the effectiveness and examines the implementation of screening and~     brief intervention techniques to delay initiation and reduce substance use among adolescents~     accessing medical care in Federally Qualified Health Care settings with a~     computer-facilitated intervention. The primary hypothesis is that participants in the~     intervention groups will be more likely to cease or reduce substance use at follow-up~     compared to clients in the treatment as usual condition.~   "
156061|NCT01523431|"~     The purpose of this study is to investigate the influence of dose selection of CPT-11 on~     toxicity, response and pharmacokinetics according to UGT1A1 genotype in colorectal cancer~     patients.~   "
156067|NCT01523353|"~     Each year in the UK around 1500 patients undergo surgery for bowel cancer that has spread to~     the liver. This is major surgery that offers a chance of cure, but can be associated with~     complications. Fitter patients are less likely to have serious complications. We are~     interested in finding out whether a short exercise program can improve patient fitness before~     surgery and whether this can reduce surgical complications.~      We plan to measure the fitness of patients who are going to have liver surgery. We will then~     give them an exercise programme for 4 weeks, after which we will assess their fitness again.~      We are also interested in whether fitter people have better Liver function. To assess this we~     will take a small sample of liver tissue during the operation for laboratory analysis of its~     function.~      Hypothesis~        1. A short period of exercise can significantly improve fitness prior to liver surgery~        2. Greater Fitness is associated with better liver function.~   "
156068|NCT01523340|"~     1. Trial design: Prospective observational study~        2. Target population: 200 NSCLC patients with histologically or cytologically confirmed~          stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who~          consent for study participation and meet the study selection criteria~        3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations~          in NSCLC patients treated with Erlotinib~             -  C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR~        4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome~          (Overall Response Rate, Progression Free survival )~        5. Duration of Trial Recruitment: 2 years~   "
156069|NCT01523327|"~     Association of maternal uric acid with maternal condition and fetal outcome in pregnant women~     with hypertension.~   "
156070|NCT01523314|"~     The research group has developed new ocular drug delivery technology based on cyclodextrin~     nanoparticles (NP). The investigators plan to develop and test this technology to help treat~     diabetic macular edema (DME).~      An important step in research was the invention of cyclodextrin nanoparticles, which has just~     received a US patent. The investigators pre-clinical and clinical work has demonstrated the~     investigators eye drop suspension with cyclodextrin nano-particles to be superior to~     conventional eye drops. They increase drug absorbance into the eye and decrease systematic~     distribution of the drug, hence reducing side effects. Cyclodextrin nanoparticle eye drops~     deliver drugs to the posterior part of the eye, thus solving one of the biggest obstacles in~     ocular pharmacology.~   "
156071|NCT01523301|"~     The purpose of this study was to show superiority of Rotigotine over placebo on improvement~     of depressive symptoms in subjects with idiopathic Parkinson's disease.~   "
156072|NCT01523288|"~     The projects aim is to investigate the intestinal function of patients suffering from~     Prader-Willi Syndrome. The methods used are ultrasonographic measurement of the rectal~     diameter and gastrointestinal transit time~   "
156073|NCT01523275|"~     This is a randomized, prospective, double-blind, placebo-controlled clinical trial of the use~     of mitomycin-C topical application as an adjunctive treatment in the endoscopic surgical~     treatment of patients with laryngotracheal stenosis. We hypothesize that the use of~     mitomycin-C improves patient outcome in the endoscopic surgical treatment of laryngotracheal~     stenosis.~   "
156074|NCT01523262|"~     Primary To investigate whether peripheral predonditioning induced by brief, intermittent~     constriction of blood supply to an arm can reduce the incidence of perioperative myocardial~     ischemia in patients operated electively for infrarenal aortic aneurysm.~      Secondary To investigate the impact of peripheral preconditioning on perioperative~     inflammatory response.~      To investigate whether peripheral preconditoning can protect against perioperative myocardial~     infarction and reduced cardiac pump function.~   "
156075|NCT01523249|"~     The purpose of this study is to compare accuracy of a new three-dimensional ultrasound (3D~     US) technique with the traditional palpation method for identification of the needle~     insertion site on patients' skin before epidural needle placement in pregnant women. The~     investigators hypothesize that the needle puncture site identified by 3D US is located within~     a 5 mm radius from the puncture site identified by palpation.~   "
156076|NCT01523236|"~     The objective of this study is to evaluate the clinical equivalence of the test formulation~     of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva~     Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) to the marketed~     formulation Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg/actuation~     (Schering) in patients with seasonal allergic rhinitis.~      In addition, the efficacy of both the test and reference nasal sprays will be compared to a~     placebo nasal spray and safety will be compared.~   "
156077|NCT01523223|"~     This phase I trial studies the side effects and the best dose of donor CD8+ memory T-cells in~     treating patients with hematolymphoid malignancies. Giving low dose of chemotherapy before a~     donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may~     also stop the patient's immune system from rejecting the donor's stem cells. The donated stem~     cells may replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-cancer effects). Giving an infusion of the donor's T cells (donor lymphocyte~     infusion) after the transplant may help increase this effect~   "
156087|NCT01523093|"~     The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8~     mg orally disintegrating tablets of OHM Laboratories Inc (A subsidiary of Ranbaxy~     Pharmaceuticals Inc, USA) with Zofran ODT® 8 mg orally disintegrating tablets of~     GlaxoSmithKline, USA in healthy, adult, human, male subjects under fasting condition.~   "
156088|NCT01523080|"~     The study was to compare single-dose oral bioavailability of acetaminophen 650 mg extended~     release geltabs (containing acetaminophen 650 mg) of OHM Laboratories Inc. (subsidiary of~     Ranbaxy Pharmaceuticals Inc., USA) with Tylenol 8 hour extended release gel tabs (containing~     acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals, U.S.A in healthy,~     adult, male human subjects under fasting condition.~   "
156098|NCT01522950|"~     This is a randomized, double-blind, placebo-controlled study comparing the efficacy of~     nebivolol and atenolol at improving small artery elasticity and reducing cardiovascular~     disease risk in subjects with early vascular disease. Approximately 75 subjects with~     borderline/elevated blood pressures and impaired endothelial function, as measured by~     arterial elasticity scores, will be recruited and assigned to treatment groups using a block~     randomization scheme. Patients will be randomly allocated to nebivolol, atenolol or placebo,~     and then followed for 9 months.~   "
156078|NCT01523210|"~     Intramuscular application of botulinum toxin (BoNT) is used as a successful therapy of muscle~     spasticity. Clinical practice shows, that even with the use of special guidance techniques to~     increase accuracy of targeting, BoNT may spread to adjacent sites by diffusion. This causes~     fluctuating treatment response, unintended side effects, and decrease of effect due to~     production of antibodies. Hence, clinicians require increase of efficacy and safety by dose~     reduction, improvement of injection technique, and additional treatment strategies. Referring~     to this, animal model showed increased efficacy and decreased systemic side effects of BoNT~     in the injected muscle after active or passive manipulation of muscle. The mechanism of this~     effect remain unclear.~      T2 and (Diffusion Tensor Imaging) DTI technique can evaluate the in-vivo distribution of~     fluids in human skeletal muscle. In addition, it allows to differentiate denervated muscle~     tissue, caused by BoNT injections, from surrounding unaffected muscle tissue.~      Up to the investigators knowledge, neither a human, in vivo measurement of the influence of~     passive muscle activity on the area of denervation, nor the primary, in-vivo distribution of~     BoNT within spastic human muscle tissue, been evaluated.~      The aim of this explorative study is:~        -  to monitor the inflow and regional distribution of the injection bolus by dynamic~          T2-weighted-, DTI-sequences;~        -  to assess the effect of passive muscle exercise on the area of denervated, caused by~          BoNT, measured by DTI-, T2-weighted and flair sequences.~      The investigators hypothesize, that~        -  intramuscular denervation area, measured by DTI-, T2-weighted and Fluid Attenuated~          Inversion Recovery (FLAIR) sequences, 3 weeks after routine BoNT injection, is~          facilitated by passive muscle exercise;~        -  primary distribution of the injected BoNT bolus can be non-invasively monitored by~          dynamic T2-, DTI- and T2 weighted sequences.~      Therefore, in this investigator blinded, cross-over study, 6 patients suffering from upper~     limb spasticity, including musculus biceps brachii, will be investigated. (Magnetic Resonance~     Tomography) MRI of the musculus biceps brachii will be performed at two consecutive, routine~     BoNT-injection days (baseline and week 16). Patients receive dosage as clinically indicated,~     due to routine treatment. Patients will be randomised to receive thirty minutes of~     physiotherapy of the affected arm, including exercise of the elbow flexors, at one of the~     injection days (baseline, or week 16, respectively). In addition, MRI will be repeated 3~     weeks after injection.~   "
156079|NCT01523197|"~     Obstructive Sleep Apnea Syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) are~     two diseases that often coexist and are called overlap syndrome(OS). Compared to single OSAS,~     OS patients are more susceptible to serious hypoxia and hypercapnia especially during sleep,~     and are much more likely to result in pulmonary hypertension and cor-pulmonal.~      With a more flexible expiratory positive airway pressure (EPAP), auto-trilevel ventilation~     may be superior to fixed bilevel positive airway pressure (BiPAP) ventilation in both~     removing residual obstructive sleep apnea hypopnea events and correcting hypercapnia~     simultaneously. The overall purpose of this study is to compare the curative effects between~     fixed BiPAP and auto-trilevel ventilations on OS patients.~   "
156080|NCT01523184|"~     This will be a single-center, randomized, parallel group, multiple dose administration,~     double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small~     bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation.~     Four groups including a placebo group will be enrolled and will receive multiple oral doses~     of YKP10811 or matching placebo.~   "
156081|NCT01523171|"~     Primary Objective:~      - To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated~     with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2~     or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF),~     or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen~     volume at the end of 6 treatment cycles;~      Secondary Objectives:~        -  To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as~          measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary~        -  To evaluate the durability of splenic response~        -  To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6~        -  To evaluate the splenic response to SAR302503 at the end of Cycle 3~        -  To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden~        -  To evaluate the safety and tolerability of SAR302503 in this population~        -  To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted~   "
156082|NCT01523158|"~     Hay fever (seasonal allergic rhinitis) results from allergy to grass and tree pollen. The~     majority of affected individuals manage well with medication from the Pharmacy or from their~     general practitioner (GP), but for some severely affected people it severely impacts on~     quality of life. Less than 40% of those affected in UK general practice feel that these~     medications achieve good symptomatic control.~      Specific immunotherapy or desensitisation is the practice of administering small amounts of~     allergen to allergic patients in increasing doses. This treatment is highly effective in~     these patients and furthermore is truly disease-modifying, with benefits persisting~     long-term, even when the treatment has been completed. Desensitisation is a routine treatment~     in the UK, Europe and North America. The exact immune mechanisms that underlie this~     symptomatic improvement are not entirely clear. Dr Tarzi, Professor Frew and Professor Kern~     have recently developed new methods for the investigation of immune responses to allergens.~     These methods require relatively small blood samples and may provide useful information about~     how immunotherapy exerts its effects. In addition to improving the investigators basic~     understanding of this treatment, such knowledge may drive improvements in the treatment and~     could be useful for monitoring patients for response. The investigators study proposes to~     investigate changes in the immune responses to pollen allergens during immunotherapy. Blood~     will be taken just prior to the first immunotherapy injection and again just prior to the~     final injection. In this way the investigators will be able to compare the immune responses~     to pollen allergen before and after treatment.~   "
156083|NCT01523145|"~     Atrial fibrillation is the most common arrhythmia and affect 1-2 % of the population in the~     western world. Atrial fibrillation can be treated with a relatively new procedure, called~     radiofrequency ablation.~      The aim of this study is to explore if patients treated with ablation for atrial~     fibrillation, benefit from an integrated rehabilitation programme, that consist of physical~     training and psycho-educative consultations with a specialised nurse.~      The hypothesis is, that integrated rehabilitation can improve mental health, physical~     capacity and other factors.~   "
156084|NCT01523132|"~     The study is a prospective cohort study following breast cancer patients from before surgery~     to one year after. The aims of the study are to determine risk factors that predispose to the~     development of persistent pain.~   "
156085|NCT01523119|"~     The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8~     mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy~     Pharmaceuticals, USA) with Zofran ODT® 8 mg orally disintegrating tablets of Cardinal health,~     UK for GlaxoSmithKline, USA in healthy, adult, human, male subjects under fed condition.~   "
156086|NCT01523106|"~     This is a randomized, double-blind, placebo-controlled study, comparing the effect of~     L-carnitine vs placebo on fatigue among Crohn's disease patients.~      The specific aim of this study is to determine if treatment with L-carnitine is more~     effective than placebo at decreasing fatigue severity scores, while accounting for disease~     activity and concomitant anemia, depression/anxiety and poor sleep quality.~   "
156089|NCT01523067|"~     The primary objective of the study is to evaluate the safety and tolerability of single~     ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with Stage~     1 or Stage 2 essential hypertension.~      The secondary objectives of the study are to characterize the pharmacokinetic profile of~     single ascending doses of Vasomera and the relationship between serum concentrations of~     Vasomera and change in systolic and diastolic blood pressure as measured by:~        -  Mean change from baseline in 24-hour systolic and diastolic blood pressure measured by~          ambulatory blood pressure monitoring (ABPM) as compared to placebo.~        -  Identification of the minimum and maximum decrease in systolic and diastolic blood~          pressure as measured by ABPM.~        -  Mean change from baseline in cuff systolic and diastolic blood pressure as compared to~          placebo.~        -  Effect of Vasomera on pulse pressure and heart rate.~      An additional secondary objective of this study will be to characterize the immunogenicity~     profile of Vasomera following a single subcutaneous dose.~   "
156090|NCT01523054|"~     The objective of the study was to compare treatment with two different oral formulations of~     metoprolol, metoprolol immediate release (IR) and metoprolol extended release (CR/XL) in~     patients with acute myocardial infarction regarding the following:~      Pharmacokinetics, peak and trough plasma concentrations and area under the plasma~     concentration curve.~      Pharmacodynamics, hourly means of Holter recorded heart rate. Tolerability. An open,~     randomised design with two parallel groups was employed.~   "
156091|NCT01523041|"~     This trial is conducted in Europe. The aim of this trial is to compare two formulations of~     biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart~     50 and biphasic insulin aspart 70 in healthy male subjects.~   "
156092|NCT01523028|"~     Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more~     important, hence underlying the importance of better understanding the fate of these~     potential health promoting antioxidants. However, some analytical barriers as well as some~     key aspects of metabolism still remain to be fully elucidated to get the full picture of~     coffee metabolism and bioavailability. One aspect addressed in the present study is the~     impact of food matrix in modulating absorption, plasma appearance and urinary excretion of~     coffee bioactives.~   "
156093|NCT01523015|"~     The high cancer related mortality has remained a significant issue of health care in Poland,~     Europe and worldwide. The decreasing incidence rate for carcinoma of the distal stomach and a~     marked trend of increasing incidence for adenocarcinoma of the esophago-gastric junction and~     esophagus has been observed in the developed countries. The most eminent drawback of majority~     commonly cited randomized trials is heterogenicity of cancer patient population. The~     epidemiological, pathological, and clinical data clearly suggest that adenocarcinoma of the~     esophago-gastric junction is the entirety different both from adenocarcinoma of the esophagus~     and adenocarcinoma of the stomach. The experience in a combined modality therapy for~     adenocarcinoma of the esophago-gastric junction have been extrapolated from studies on~     esophageal or gastric cancer, where the investigated population involved in part patients~     with carcinoma of the esophago-gastric junction. The proposed study has been designed to~     achieve the following objectives:~        -  The assessment of safety and efficacy of a combined modality therapy in homogenous~          patient population with adenocarcinoma of the esophago-gastric junction excluding~          individuals with adenocarcinoma of the esophagus or the stomach;~        -  The assessment of safety of a combined modality therapy in a form of chemo- and~          chemoradiotherapy related toxicity and impact of chemo- and chemoradiotherapy on~          postoperative morbidity or mortality rates;~        -  The assessment of efficacy of a combined modality therapy in a form of rate of response~          of the tumor to chemo- and chemoradiotherapy and a curative resection rate.~        -  The assessment of efficacy of a combined modality therapy in a form of cancer free~          survival and overall survival.~   "
156094|NCT01523002|"~     Pyronaridine: artesunate (Pyramax) is an antimalarial fixed-dose combination therapy which~     has been demonstrated to be well tolerated and effective treatment in patients with~     Plasmodium falciparum and vivax malaria.~      This open-label Phase I study has two parts: a drug-drug interaction part intended to~     investigate the interaction of Pyramax in the pharmacokinetics of the CYP2D6 probe metoprolol~     and a re-dosing evaluation part intended to investigate the differences on the changes in~     liver enzymes induced by Pyramax in a first and in a second treatment course and the effect~     of the redosing interval on the changes in liver enzymes induced by Pyramax in a first and in~     a second treatment course.~   "
156095|NCT01522989|"~     This study is for patients with advanced solid tumor malignancies (cancer that has spread to~     other parts of the body).~      The purpose of this study is to test the safety and effectiveness of a new combination of~     drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor~     malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called~     cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this~     enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil~     and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus~     decreasing the tumors in the body.~      PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been~     approved by the Food and Drug Administration for use in colorectal cancer. It is given as a~     pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and~     Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved~     for and used as chemotherapy for several cancers.~   "
156096|NCT01522976|"~     This randomized phase II/III trial studies how well azacitidine works with or without~     lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or~     chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in~     different ways to stop the growth of cancer cells, either by killing the cells, stopping them~     from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of cancer~     cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine~     is more effective with or without lenalidomide or vorinostat in treating myelodysplastic~     syndromes or chronic myelomonocytic leukemia.~   "
156097|NCT01522963|"~     The purpose of this study is to determine the timeframe (relative to a stress task) that is~     most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that~     occur when smokers are presented with stressful situations.~   "
156100|NCT01522924|"~     This study determines if there is a difference in dental students' attitudes, perceived~     barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation~     treatment, and cessation knowledge in those students receiving a tobacco cessation lecture~     along with practice sessions using standardized patients and those students receiving only a~     tobacco cessation lecture. The study determines if dental students' use of tobacco affects~     their intent to provide cessation treatment to patients, and if the time between receiving~     the lecture and participating in the practice sessions using standardized patients makes a~     difference in dental students' attitudes, perceived barriers, subjective norms. perceived~     skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge.~   "
156101|NCT01522911|"~     To date there are no data suggesting substantial effects of hormonal interaction after~     percutaneous closure of the left atrial appendage (LAA). Our hypothesis is that by excluding~     the LAA from blood flow physiologic stimuli for ANP and BNP produce may be impaired and~     consecutive release of the hormones may be reduced. Here, we present our experience of ANP~     and BNP secretion in the early postprocedural period after transcatheter closure of the LAA.~   "
156102|NCT01522898|"~     Cardiac resynchronization therapy (CRT) is a treatment for heart failure in patients who also~     suffer from ventricular dyssynchrony, a form of uncoordinated contraction of the ventricle~     (lower pumping chamber of the heart). In the past decade, CRT has become an established~     treatment for heart failure patients who are in normal rhythm, called sinus rhythm. An~     important subset of heart failure patients are those with atrial fibrillation (AF), who make~     up around 1 in 4 HF patients, and are over-represented amongst HF patients with more advanced~     symptoms. In heart failure patients with AF, CRT has proven not to be as effective as in~     sinus rhythm, due to competition between beats generated by the CRT device and beats~     conducted from the heart's own electrical conduction system. In the current study, we aim to~     test the hypothesis that ablating the AV node, which controls electrical conduction from the~     heart's atria (top chamber) to its ventricles (lower chambers), will improve survival and~     heart failure symptoms in CRT patients with co-existent AF. The results are important,~     because they will provide a way of passing on the benefits of CRT, such as improved survival,~     less heart failure symptoms, and better quality of life, to heart failure patients who also~     suffer from AF.~   "
156103|NCT01522885|"~     The purpose of this study is to investigate whether if KatGuide (a new developed medical~     device) improves the placing of a large bore chest tube in the pleural cavity compared to the~     conventional method.~   "
156104|NCT01522872|"~     This phase 2 study is designed to evaluate the safety and tolerability activity of TH-302 and~     dexamethasone with or without bortezomib or pomalidomide in subjects with relapsed/refractory~     multiple myeloma.~   "
156105|NCT01522859|"~     The the aim of this study is to determine the benefits of Telehealth monitoring in the~     management of patients with chronic obstructive pulmonary disease.~   "
156106|NCT01522846|"~     Heparinized solution has been used for maintenance of arterial catheter during perioperative~     period. Although the infused dose of heparin is very low, the investigators examine whether~     the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM)~     analysis.~   "
156107|NCT01522833|"~     With roughly 80% of cancer patients receiving their oncology care in the community setting,~     the investigators are proposing to sample from a community-based center to evaluate the~     percentage of epidermal growth factor receptor (EGFR)-wild type patients that gain benefit~     from erlotinib and assess the clinical characteristics that are associated with~     erlotinib-responders. Additionally, biopsy specimens from enrolled patient cases that are~     EGFR-wt will be evaluated via exploratory genetic analysis for correlated markers.~   "
156108|NCT01522820|"~     This phase I trial studies the side effects and best schedule of vaccine therapy with or~     without sirolimus in treating patients with cancer-testis antigen (NY-ESO-1) expressing solid~     tumors. Biological therapies, such as sirolimus, may stimulate the immune system in different~     ways and stop tumor cells from growing. Vaccines made from a person's white blood cells mixed~     with tumor proteins may help the body build an effective immune response to kill tumor cells~     that express NY-ESO-1. Infusing the vaccine directly into a lymph node may cause a stronger~     immune response and kill more tumor cells. It is not yet known whether vaccine therapy works~     better when given with or without sirolimus in treating solid tumors.~   "
156109|NCT01522807|"~     The purpose of the study is to evaluate the plasma drug concentrations of three formulations~     of PF-05190457 after administration of single doses to healthy volunteers.~   "
156110|NCT01522794|"~     The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer NOX-H94 on~     iron homeostasis during systemic inflammation induced by endotoxin.~      In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an~     inflammatory response with release of pro-inflammatory cytokines, such as IL-6 and TNF-alfa,~     with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron~     concentrations decrease.~      This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin~     and to prevent serum iron decrease in a pathophysiological model prior to studying the~     efficacy of NOX-H94 in patients with anemia of chronic disease.~   "
156111|NCT01522781|"~     The purpose of this study is to obtain a prospective database which will allow analysis of~     total knee outcomes.~   "
156112|NCT01522768|"~     The purpose of this study is to find out what effects, good or bad, the combination of~     standard chemotherapy agent paclitaxel with the investigational (experimental) drug afatinib~     that targets HER2, has on HER2-positive esophagogastric cancer that started to get bigger~     despite previous treatment with trastuzumab. The doctors will also study the tumor to~     understand why it grew while on trastuzumab treatment and to see the effects afatinib and~     paclitaxel has on the tumor.~   "
156139|NCT01522417|"~     The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a~     shortened infusion duration compared to label-dosing eptifibatide in patients undergoing~     percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of~     death, PCI-related myocardial infarction, urgent target vessel revascularization or~     in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever~     comes first.~   "
156155|NCT01522209|"~     The study compares the established imaging techniques (CT, MRT, Contrast Ultrasound) with the~     new method of intraoperative contrast enhanced ultrasound to compare all methods for their~     rate of detection of colorectal liver metastasis.~   "
156113|NCT01522755|"~     Pacing leads are key elements of a pacing system as their proper functioning is one of the~     major factors affecting the long term performance of the whole system.~      Success of a pacing lead implant can be defined considering 3 items: ease of lead implant,~     lead stability and lead electrical performances.~      These factors may be related to the physician experience (global implant experience,~     experience with a given lead), to the implant procedure (lead access, lead position, implant~     time, scopy time) to the lead (handling and mechanical characteristics) and to the patient~     (ischemic history).~      Even though implant success rate is quite high with currently available leads, the weight of~     the different factors influencing success has never been studied systematically. The~     objective of the current study is then to define the predictive factors of an implant success~     with the CapsureFix MRI model 5086.~      This lead has been selected because it has been available for a short period, so the~     investigators have a limited experience of it and it has a unique design which makes it~     conditionally safe in an MRI environment and which may be associated with specific handling~     characteristics.~   "
156114|NCT01522742|"~     The main aims of this study are to determine whether: a) psoriasis patients with or without~     arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of~     etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by~     their treating clinicians) will decrease cardiovascular inflammation.~   "
156115|NCT01522729|"~     Recently, direct evidences point to the contributing role of peripheral muscle fatigue in~     exercise tolerance among patients with COPD. However, the physiological mechanisms by which~     peripheral muscle fatigue impairs exercise tolerance are still unknown, as factors regulating~     peripheral muscle fatigue in COPD may be complex. One possible link between limb muscle~     fatigue and exercise intolerance could be enhanced afferent signals from the active limb~     muscles to the central command, thereby limiting central motor output and eventually leading~     to exercise termination.~      A direct method to investigate the regulation of peripheral muscle fatigue during exercise in~     patients with COPD is the blockade of peripheral neural afferents via lumbar anesthesia.~     Consequently, investigating the interplay between the peripheral muscular component and the~     central motor command during self-paced exercise could shed light on the regulation of~     peripheral muscle fatigue in COPD and its implication in exercise intolerance.~   "
156116|NCT01522716|"~     The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as~     treatment for steroid-refractory chronic graft-versus-host disease.~   "
156117|NCT01522703|"~     The primary objective of this study is to determine if broccoli sprouts (BS) improves airway~     inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen~     sensitization.~      The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in~     40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be~     randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a~     sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.~   "
156118|NCT01522690|"~     The objective of this study is to obtain normative accelerometry data during the six minute~     walk test and a 30 second walk test on healthy subjects in order to determine the~     accelerometric variables that are the most relevant to describe gait disorders in patient~     populations. Secondary objectives of this study are to investigate the impact of walking~     speed and muscle strength on the accelerometric parameters, to assess the reproducibility of~     the method and to compare accelerometric data obtained with two different devices.~   "
156119|NCT01522677|"~     The central hypothesis for this study is that it is safe and feasible to administer~     intraluminal photodynamic therapy (PDT) to colon cancers by colonoscopy to induce localized~     inflammatory/immune response. The objective is to demonstrate the feasibility and safety of~     PDT to colon cancer patients administered before surgery and to characterize the~     inflammatory/immune response at the tumor site and systemically. The long-term objective of~     these studies is to modify he natural biology of colorectal cancers and improve patient~     survival.~   "
156120|NCT01522664|"~     This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A~     in patients with metastatic or unresectable melanoma. Cohorts of patients will receive~     escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the~     absence of disease progression or unacceptable toxicity, patients may continue to receive~     DEDN6552A for up to 17 cycles (1 year).~   "
156121|NCT01522651|"~     The purpose of this study is to evaluate whether treatment with ranolazine or low dose~     dronedarone reduces atrial fibrillation burden (AFB) in subjects with paroxysmal atrial~     fibrillation (PAF), and whether combination therapy (ranolazine and low dose dronedarone) is~     superior to individual drug therapy in reducing AFB.~      This phase 2 clinical trial will be conducted over 16 weeks and involves a Screening period~     (4 weeks) and a Treatment period (12 weeks). The final follow up visit will occur 2 weeks~     after the end of the Treatment period. Primary and Secondary endpoints will be evaluated~     according to treatment group, clinic visit period, and the overall Treatment period. Safety~     analyses will be conducted at each clinic visit, and include: cardiac rhythm monitoring, ECG~     testing, laboratory evaluation, and symptom and adverse event assessment.~   "
156122|NCT01522638|"~     The purpose of this study is to determine the anatomy of the retina and the optic nerve in~     patients with autosomal dominant optic atrophy (ADOA). Based on these findings the aim of the~     study is to determine why patients with the same type of genetic material, i.e. the same~     mutation, have such large variations of symptoms, spanning from unaffected subjects to~     blindness. The project requires examination of both healthy and affected family members.~   "
156123|NCT01522625|"~     This study aims to clarify whether patients with chronic hepatitis B with high viral load~     will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.~   "
156124|NCT01522612|"~     OBJECTIVE: The principal objective of the trial is to evaluate whether the addition of~     cetuximab associated with 5-fluorouracil in elderly patients with KRAS wild type advanced~     colorectal cancer (CRC) prolongs Progression Free Survival, compared with 5-fluorouracil~     alone.~   "
156125|NCT01522599|"~     The main objective of this randomized multicenter clinical trial is to test the hypothesis~     that further reduction of VT to 4mL/kg may enhance lung protection in patients with ARDS as~     compared to the conventional ARDS-Net ventilation. Control of PaCO2 in the ~4 ml/kg arm~     would be accomplished by LFPPV- ECCO2-R.~   "
156127|NCT01522573|"~     The purpose of this registry is to record information and evaluate the impact of Endoscopic~     Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the~     management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and~     technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde~     cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided~     ERCP procedures have been assessed in a series of studies.~      This multi-center registry has been initiated:~        -  To document the impact of EUS-Guided ERCP procedures on the management of~          pancreatico-biliary disorders including malignancies.~        -  To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic or~          therapeutic procedures.~      Design is retrospective and prospective registry study.~      Procedures that will be captured include:~        1. EUS-Coils placement~        2. EUS Glue injection~        3. EUS-Fiducial placement~        4. EUS-Neurolysis~        5. EUS-Stent placement~        6. EUS-alcohol injection~        7. EUS-fluid collection, abscess or cavity drainage~        8. EUS guided ductal drainage~        9. EUS-guided Ablation~       10. EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary~          duct drainage~   "
156128|NCT01522560|"~     Professionalism is one of the six competences required by The Accreditation for Graduate~     Medical Education Outcome Project to be taught and evaluated during residency. Anesthesia~     residents are faced with unique communication challenges in their practice including brief~     contact time with their patients, operating room efficiency pressure, etc. To assess~     professionalism in Anesthesiology residents is important to obtain evaluations from people~     with whom they interact including patients, surgeons, colleagues and members of the support~     team. The Multisource feedback (MSF) approach has been used to evaluate communication skills~     and professionalism among practicing physicians and residents in a variety of settings. This~     evaluation model has never been used previously to evaluate anesthesia residents. The~     investigators propose a randomized controlled trial to validate and evaluate a MSF in~     professionalism for anesthesia residents. Participants include eighty residents doing two~     months rotation in Pediatric Anesthesia Department at The Cleveland Clinic Anesthesia~     Institute from July 1, 2011 and June 30, 2013. MSF questionnaires will be validated using~     face and content validity methods and comparing them with the current system of evaluation.~     Residents will be randomly assigned to a feedback group or to the control group. Both groups~     will receive MSF evaluation from the faculty, patients' parent and coworker. Only the group~     assigned to feedback is going to have a 'coaching meeting' every month to identify strengths~     and weaknesses and create strategies for improvement. The investigators are planning to~     compare the mean values of the baseline evaluations with the mean values obtained after the~     first and second months from the MSF.~   "
156129|NCT01522547|"~     The purpose of the study is to determine the maximum tolerated dose, safety and effect on~     induction of fetal hemoglobin of pomalidomide in patients with Sickle Cell Disease.~   "
156130|NCT01522534|"~     The purpose of the study is to determine the efficacity of a simple blind technic of loco~     regional anaesthesia of the sciatic nerve compared to the gold standard in emergency medecine~     : the intravenous morphine for treated the severe pain of leg, ankle or foot trauma in the~     prehospital setting and mountain rescue.~   "
156131|NCT01522521|"~     The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese~     patients with primary osteoporosis.~   "
156132|NCT01522508|"~     The aim of this prospective randomized study was to evaluate the ability of the new Analgesia~     Nociception Index ANI, derived by heart rate variability, to detect painful stimulation~     during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.~   "
156133|NCT01522495|"~     Little is known about chronic wound microenvironments, especially in peripheral vascular~     disease (PVD) and diabetic patients. At the demarcation line, the percentage of viable cells~     and tissue is unclear. A means to determine cell viability, particularly discerning an~     apoptotic or necrotic cell pathway would indicate where the line of demarcation should be~     drawn. The information generated would better predict clinical outcome using SPY Imaging.~     Cellular studies are needed to successfully confirm a clear line of demarcation to eliminate~     surgeon subjectivity.~   "
156134|NCT01522482|"~     Cardiovascular disease (CVD) is the greatest cause of morbidity and mortality in the UK.~     Abnormalities in the concentration and/or composition of lipoproteins (the lipid carrying~     particles), in particular low density lipoproteins (LDL) in circulation, is one of the most~     important physiological defects contributing to the development of CVD.~      The LDL cholesterol (LDLC) response to fatty acid change is in part mediated by the APOE~     genotype, with E4 individuals (25% of the UK population) being most responsive to changes in~     dietary fats, showing greater reductions when low levels of saturated fats or fish oils are~     consumed and greater increases when high levels of these fats are consumed. Therefore the~     aims of the present study is to understand the mechanism that regulates the higher LDLC~     response associated with saturated fatty acids and fish oil consumption in healthy men~     prospectively recruited based on their APOE genotype.~   "
156135|NCT01522469|"~     This is a Phase II open label study of crenolanib besylate. This study will enroll subjects~     with relapsed or refractory AML with FLT3 activating mutations. Prior treatment with other~     FLT3 TKIs is allowed. Subjects will take crenolanib 200mg/m2/day divided in three doses daily~     (preferably every eight hours), taken orally at least 30 minutes pre or post meal until~     disease progression, death, or the patient discontinues treatment for adverse events,~     investigator's judgment, or other reasons. Patients who are able to proceed to allogeneic~     stem cell transplant will be able to resume crenolanib therapy post-transplant in an attempt~     to maintain remission.~   "
156136|NCT01522456|"~     To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to~     Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3~     weeks in terms of local tolerability parameters (erythema, dryness, scaling,~     stinging/burning) and preference.~   "
156137|NCT01522443|"~     Bone metastases and associated pain are a major cause of morbidity and mortality in~     castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability~     to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated~     by lack of resolution of lesions on bone scan with these agents) or the pain associated with~     these metastases.~      This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on~     pain response and bone scan response in men with CRPC.~   "
156140|NCT01522404|"~     The purpose of this study is to find out if atomoxetine causes a change in the biologic~     markers (substances that may indicate the presence of a disease) in the cerebrospinal fluid~     (CSF) of participants diagnosed with Mild Cognitive Impairment (MCI). In this research study,~     the spinal fluid of subjects with MCI who take atomoxetine will be compared to spinal fluid~     of those who take capsules containing inactive material, also known as placebo. At the~     six-month timepoint, subjects who were taking placebo during the first six months will be~     placed on active study medication, and those who received active study medication will be~     reassigned to placebo. After completion of the study, subjects will be able to receive~     open-label atomoxetine.~      This study will also evaluate if the drug is safe and well-tolerated. Additionally,~     information will be gathered to identify the dose of atomoxetine that is most beneficial, and~     how taking this medication affects thinking and behavior, as well as imaging and blood~     biomarkers. The results of this research will help determine if atomoxetine alters signs of~     inflammation and other biomarkers associated with Alzheimer's disease.~   "
156141|NCT01522391|"~     The primary objective of this study was to evaluate microbial density in eczematous lesions~     during two weeks of twice daily therapy with the investigational product, DPK-060 1%~     ointment, compared with placebo in patients with atopic dermatitis. This randomized,~     double-blind, placebo-controlled part of the study was preceded with an open-label~     investigation in a small group of patients (n=5) treated with two applications of DPK-060 1%~     ointment per day for four days to assess safety, local tolerability and systemic absorption~     of DPK-060.~      The secondary objectives were to evaluate severity of eczema and pruritus, to assess the~     tolerability and safety of the treatment and to assess the degree of systemic absorption of~     DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.~   "
156142|NCT01522378|"~     Subjects were recruited if their healthcare provider decided that they needed treatment with~     a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators~     did this study to see if part of the nerve organ, called the sympathetic nervous system, may~     be responsible for the improvement seen in patients that receive biventricular pacing. The~     investigators had three ways to measure sympathetic nervous activity: 1) by using a special~     blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.~   "
156143|NCT01522365|"~     This study has been designed in order to collect data with regards to the peri-implant tissue~     outcome of abutment-supported restoration and direct implant-fixed restoration. Therefore a~     small group of subjects with partly edentulous maxilla is selected to show that both~     techniques are efficient and safe and to show comparable peri-implant tissue outcome for both~     methods. At the time of impression forming for each centre treatment A (= abutment-supported~     XiVE® CAD/CAM supra-structure) and B (= direct implant-fixed XiVE® CAD/CAM supra-structure)~     is assigned to the left and right side of the maxilla by being randomized at the time of~     impression forming.~   "
156144|NCT01522352|"~     This study suggests for the first time a comparison of the hemodynamic performance of the two~     most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available~     since September 2010 at the University Hospital of Clermont Ferrand.~   "
156145|NCT01522339|"~     The purpose of this study is to determine the safety of a customized MRI scanner and gather~     preliminary data on image quality in a group of 10 medically stable infants admitted to the~     Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC).~   "
156146|NCT01522326|"~     The objective of this study is to determine the efficacy of metoclopramide in relieving the~     symptoms of Acute Mountain Sickness (AMS).~      It is our hypothesis that the combined antiemetic and analgesic effects of metoclopramide~     (which has been study-proven to be effective in relieving symptoms of migraine headache) will~     prove to be more efficacious in relieving symptoms of acute mountain sickness than the~     standard, previously-studied analgesic medication, ibuprofen.~   "
156147|NCT01522313|"~     This study investigates the influence of perioperative changes in serum creatinine on~     hospital length of stay and mortality.~   "
156148|NCT01522300|"~     The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis~     in detecting the multicentricity of mammary tumor.~   "
156149|NCT01522287|"~     The goal of this project is to improve access to effective treatments for obsessive~     compulsive disorder (OCD) through the use of web-based cognitive behavioral therapy (CBT)~     treatment. There intervention involves both a computer program (BT Steps) and human~     interaction via telephone. The investigators will test the efficacy and feasibility of~     computer therapy alone (n=35), computer plus a non-therapist coach (n=35), and computer plus~     a CBT therapist coach (n=35~   "
156150|NCT01522274|"~     This research study is for FEMALE cigarette smokers who want to quit smoking.~      Participants will be provided with brief quit-smoking education at the beginning of the study~     and will receive the nicotine patch for 10 weeks, free of charge.~      Participants will be assigned to either an exercise program or a general health education~     program. The exercise and health education programs will take place over 14 weeks, with~     follow-up appointments 3, 6, and 12 months after the end of the 14-week program.~      There is no fee for any part of this study and participants will be compensated for their~     time.~   "
156151|NCT01522261|"~     Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with~     visualization of the operative field during laparoscopic pelvic reconstructive surgery?~   "
156152|NCT01522248|"~     Some people experience symptoms just after receiving the seasonal inactivated influenza~     vaccine. The cause of some of these symptoms is likely to be an immune response to the~     vaccine. The investigators would like to look at the earliest immune responses to the~     inactivated influenza vaccine. This pilot study will help us to determine at what time points~     we should look.~   "
156153|NCT01522235|"~     The purpose of the study is to see if administering intravenous immune globulin (IVIG)~     (putting immune globulin directly into your blood) helps to improve the symptoms of~     orthostatic hypotension (sudden fall in blood pressure when a person stands up) and quality~     of life in men and women who have autoimmune autonomic ganglionopathy (AAG).~   "
156154|NCT01522222|"~     To demonstrate that using continuous mechanical lung ventilatory support in combination with~     Positive End Expiratory Pressure (PEEP)during open heart surgery will improve lung function~     and decrease lung complications after surgery.~   "
156156|NCT01522196|"~     The purpose of this study is to determine the effectiveness of A 001 infusion in preventing~     acute chest syndrome in sickle cell disease (SCD) subjects with vaso-occlusive crisis, fever,~     and elevated serum C-reactive protein (CRP).~   "
156157|NCT01522183|"~     Post-marketing safety data on patients treated and untreated with eculizumab.~   "
156158|NCT01522170|"~     There is growing but limited information on the long term clinical status of aHUS patients~     who have previously received or are continuing to receive treatment with eculizumab. This~     study is designed to collect clinical data that will provide insight into the long-term~     outcomes of patients with aHUS.~   "
156159|NCT01522157|"~     The trial will study the acute metabolic effects of three different types of diet: low-fat~     diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus~     type 2 will be recruited and each of them will be given each type of diet on three different~     days. Menus with the same energy content but with different content of fat, carbohydrate and~     protein are designed. Breakfast and lunch are served for the patients each day of testing.~     Laboratory samplings are performed six times during the day. The order of the dietary~     intervention is randomized for each patient.~      The investigators suppose to find different reaction in plasma glucose and lipids depending~     on the type of diet.~   "
156160|NCT01522144|"~     The Children's Hospital of Philadelphia's ambulatory network uses an electronic health record~     (EHR) to document clinical information. Using the EHR, a clinical decision support tool will~     be designed to help the primary care physician's in caring for children with asthma. The goal~     will be to improve the primary care physician's use of the national Institutes of Health~     guidelines for the best care for asthma. To study this EHR decision support tool, it will be~     introduced into 5 practices while 5 other practices will have the existing asthma care~     information. It will be determined whether the physicians in the practices with the decision~     support tool are better at following the asthma guidelines. If the decision support tool~     works...then it will be offered to others to use with their EHR systems.~   "
156161|NCT01522131|"~     Purpose: The proposed study will evaluate and compare the clinical response of using~     bioresorbable collagen membrane alone or defect debridement with erbium Laser irradiation in~     conjunction with bioresorbable collagen membrane in the treatment of Class II furcation~     defects in maxillary and mandibular teeth. The study will examine whether there is a superior~     regeneration potential when the laser energy is combined with membrane defect isolation.~      Procedure: The study will use 2 groups, a control group and a test group with 16 patients in~     each group, with severe chronic periodontitis having clinical or radiographic evidence of~     Class II furcation defects in the buccal or lingual of the mandibular molars or Class II~     furcation defects on the buccal of maxillary molars. 16 patients will serve as the control~     group and open flap debridement with bioresorbable collagen membrane will be the mode of~     treatment. Group 2: 16 patients will serve as the test group and will undergo open flap~     debridement in conjunction with Er, Cr: YSGG laser irradiation and a bioresorbable collagen~     membrane will be used.~   "
156162|NCT01522118|"~     Since prostate specific antigen (PSA) was introduced as a clinical screening tool for~     prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced~     disease. The present choice of treatment for men with localized prostate cancer lies between~     active surveillance and radical therapy. Thus, the option of treating only the cancer within~     the prostate gland and sparing the non-cancerous tissue is quite appealing, yet very~     controversial. At present there are no consistent scientific data on focal therapy and its~     major effectiveness.~      Focal therapy for prostate cancer is defined as therapy that selectively ablates known~     disease while preserving existing functions, with the overall aim of minimizing lifetime~     morbidity without compromising life expectancy.~      The aim of the investigators study is to test if Magnetic Resonance guided Focused Ultrasound~     ablation can determine non-invasive necrosis of focal, locally non-advanced prostate cancer.~      The study i designed as Phase 1, treatment & resection protocol. With this project the~     investigators further aim to evaluate the safety and identify side effects of Magnetic~     Resonance guided Focused Ultrasound in treating focal prostate cancer.~      This design will also expand knowledge of the effect of Magnetic Resonance guided Focused~     Ultrasound onto peri-prostatic environment and to determine if surgery can safely be adopted~     after this non-invasive treatment.~   "
156163|NCT01522105|"~     5 Children > 3months and < 16 years with Gram-positive meningitis will receive a single dose~     of daptomycin 24 hours after the first dose of ceftriaxone. 4-8 hours after daptomycin~     administration a second lumbar puncture is performed to determine the peak concentration of~     daptomycin in the cerebrospinal fluid. In parallel peak and trough level of daptomycin will~     be measured in the plasma. The investigators anticipate that daptomycin penetrates into the~     cerebrospinal fluid in bactericidal concentrations~   "
156164|NCT01522092|"~     Anxiety and depression are common in patients with severe chronic obstructive pulmonary~     disease (COPD). Frequently exacerbation's of breathlessness are associated with panic/fear~     and indeed this may be the main cause for the for hospital admission. Patients prone to a~     tendency to experience and communicate somatic distress in response to psychosocial stress~     and to seek medical help for it are top of the frequent flyer league, costing the health~     care economy dearly. This is a particular problem in Hull with the high levels of smoking and~     urban deprivation combining to place the city at the bottom of the Department of Health COPD~     league tables.~      Our hypothesis is that an effective treatment for anxiety will reduce the number of episodes~     of hospital admission by reducing the panic/fear element of mild COPD exacerbation's thus~     allowing the patient time to access the existing community based support services.~   "
156165|NCT01522079|"~     Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal~     muscular atrophy (SMA). Air stacking is a clearance airway technique frequently used but its~     effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear.~      Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic~     function in patients with spinal muscular atrophy types II and III.~      Methods: Patients with spinal muscle atrophy type II and III will be recruited.~     Electrocardiogram signals will be recorded for analyses of heart rate variability during air~     stacking in supine and sitting position.~   "
156185|NCT01521819|"~     This is a pilot, single-center, interventional clinical trial in which subjects will receive~     16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed.~   "
156166|NCT01522066|"~     An alternative to general anesthesia - which puts a patient completely to sleep - is regional~     anesthesia, where local anesthetic is injected under the skin to freeze or 'block' a nerve or~     set of nerves. This method allows a patient to be awake during surgery and avoids any~     unpleasant after-effects of general anesthetic. A regional block is normally performed by~     inserting a needle under the skin so that the needle tip is near the nerve to be blocked,~     followed by injection of a single shot of enough local anesthetic to block any sensation that~     the nerve normally provides. Although regional nerve blocks provide pain relief during a~     surgical procedure, they eventually wear off, occasionally leaving the patient to contend~     with localized pain in the part of the body that was operated on. In these cases,~     over-the-counter painkillers like Tylenol or Advil may not be strong enough to completely~     take away the pain. We believe that, instead of giving a single shot of anesthetic, patients~     can be fitted with a catheter - a thin, flexible tube - that can be used to deliver one dose~     of local anesthetic to block the nerve before surgery and which could also be used to deliver~     a second dose of anesthetic just prior to discharge from the hospital. This way, the patient~     still only receives one needle poke, but their pain can be better managed following surgery.~     Our study will compare the post-nerve block pain profiles of individuals who have received a~     single-shot injection of local anesthetic versus those who have received two doses via the~     catheter delivery method.~   "
156167|NCT01522053|"~     When anesthesiologists perform a regional nerve block, they will often put a catheter - a~     flexible plastic tube - in the patient to allow for continuous delivery of local anesthetic.~     This allows the nerve(s) to be 'frozen' so that the patient is more comfortable during and~     after surgery. The most common method of placing the catheter close to a nerve involves~     threading the catheter through a needle which has been inserted under the skin. Because the~     catheter is very thin and flexible, it does not thread well through tissue and will buckle~     and kink when enough force is applied to it. Another problem is that the puncture hole left~     by the needle is larger than the diameter of the catheter, meaning that when the needle is~     withdrawn, the catheter is not secure, which increases the chance that it will dislodge and~     cause leakage of local anesthetic. One solution to these problems is to use a catheter~     placement method similar to how intravenous catheters are installed. In this method, the~     catheter fits around ('over') the needle, which results in more support for the catheter~     while it is being pushed under the skin. We wish to examine if a catheter-over-needle method~     would be useful for placing a catheter to deliver local anesthetic during peripheral nerve~     blockade. We will compare the catheter-over-needle method to the currently used~     catheter-through-needle method on patients who require continuous anesthetic delivery for~     their surgery; half the patients will receive anesthetic through one method, and the other~     half will receive anesthetic through the other method. We believe that using the~     catheter-over-needle method will result in more secure placement of the catheter and more~     efficient delivery of local anesthetic.~   "
156168|NCT01522040|"~     This is a prospective randomized pilot study that seeks to address the research question: In~     children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard~     Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from~     patient presentation until PICU discharge?~   "
156169|NCT01522027|"~     Critically ill patients or patients under prolonged unconsciousness need a tube inserted into~     their windpipe to provide oxygen. This tube, called a tracheostomy tube, can be connected to~     a ventilation device to allow the patient to breathe when they cannot do it for themselves.~     In the hospital, doctors will perform a percutaneous tracheostomy (PT), where a needle is~     inserted through the skin of the neck into the windpipe, providing a guide for a tube that~     will dilate the tissue and create a hole that the tracheostomy tube can be inserted into.~     Although this is a common procedure in critical care units, it does carry some risks to the~     patient and is not always successful. The needle may puncture the back or side of the~     windpipe if it is inserted too far, or it can miss the windpipe altogether, causing damage to~     surrounding structures. We believe that doctors who perform PT would benefit from a method~     that improves the success rate of the procedure. We wish to test a device that alerts the~     doctor performing PT to when the needle tip is in the air-filled windpipe. The device has~     been proven to aid needle insertion in cadavers, but it needs to be tested on live patients.~     Since many intensive care patients undergo PT, we wish to test our technique on this~     population. It will be a controlled environment and the clinicians are experienced in PT.~     This technique should save valuable time, result in more accurate needle insertion, and~     lessen the risk of damaging other structures and tissues in the neck.~   "
156170|NCT01522014|"~     Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the~     geriatric population. Numerous studies have reported good mid and long term results of THA in~     patients over the age of 60 years. With the reported high success rate of this surgical~     intervention, the THA surgery is being performed in younger patients who have significant~     joint disease.~      A clinical trial, using a randomized blinded design, was undertaken to compare the functional~     outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire polyethylene liners~     in patients 60 years of age or younger with non-inflammatory arthritis of the hip.~      Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year~     follow-up is currently underway.~      The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the~     RAND-12, as well as measurement of complication and revision rates. The patient's demand on~     the implant as calculated by the patient's age, weight, health status and activity level was~     also measured.~   "
156186|NCT01521806|"~     This study will examine the effects of a dietary fiber on insulin sensitivity in overweight~     and obese women. The fiber will be added to snack foods and women will consume the foods for~     four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in~     another period. In a third period, no fiber will be added to the snack foods. Insulin~     senstivity will be measured at the end of each treatment period.~   "
156187|NCT01521793|"~     The purpose of this study is:~        -  To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once~          daily for 7 days in subjects treated previously with a single 7-day course of QLT091001~          in Study RET IRD 01~        -  To evaluate whether up to 3 additional courses of oral QLT091001 administered once daily~          for 7 days can maintain or improve visual function.~   "
195856|NCT00999752|"~     The main purpose of this study is to evaluate the effects of Nebivolol and~     Hydrochlorothiazide on blood pressure in African Americans with high blood pressure.~   "
156171|NCT01522001|"~     Cardiac rehabilitation is an individual adapted multidisciplinary intervention for people~     suffering from Heart Disease. It involves;~        -  Dietary counseling,~        -  Exercise training,~        -  Psychosocial support,~        -  Physician~        -  smoking cessation~        -  Patient education~      The purpose is quick and complete recovery and to reduce the chance of recurrence.~      In Denmark people admitted with Acute Cardiac Disease is referred to a course of hospital~     based cardiac rehabilitation at discharge.~      The Danish Municipal Reform of 2007 changed the responsibility of rehabilitation from the~     Regions, who runs the hospitals, to the municipalities.~      Shared care is in this setting that elements of treatment are completed different places in~     Health Care.~      The aim of this study is:~        -  to establish a shared care model for Cardiac rehabilitation following admission with~          Acute Coronary Syndrome and~        -  to compare this model to the existing hospital based cardiac rehabilitation after~          admission with Acute Coronary Syndrome.~      Primary outcome is participation in cardiac rehabilitation.~   "
156172|NCT01521988|"~     - Background:~      Atrial fibrillation is frequently associated with typical atrial flutter in clinical~     practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved~     in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation~     that occurs in about 70% of these patients after several years of follow-up. However, the~     latter arrhythmia is associated with significant morbidity and mortality. The problem of~     atrial fibrillation occurrence after successful ablation of typical atrial flutter remains~     physicians primary concern in monitoring these patients.~        -  Objectives:~      The purpose of this study is to demonstrate that the pulmonary veins isolation using balloon~     cryotherapy technology performed at the time of flutter ablation, significantly reduces the~     risk of developing atrial fibrillation in the two year period following the procedure.~        -  Selection Criteria:~      Patients referred for ablation of typical atrial flutter with an history of at least one~     documented episode of atrial fibrillation (atrial flutter remaining the predominant~     arrhythmia)will be enrolled in the study.~        -  Study Methods:~      This is a prospective, multicenter, randomized, 2-arms study, comparing the rate of atrial~     fibrillation occurrence over a two years period following either an ablation procedure of~     typical atrial flutter (Group 1), or a combined procedure of typical atrial flutter ablation~     and pulmonary veins cryoballoon isolation (Group 2). The enrollment period will be of 18~     months.~      Randomization will be 1:1 and will be balanced in blocks of varying size. Patients will then~     be regularly followed up clinically and by long-term ECG recordings.~        -  Evaluation Criteria:~      The primary endpoint will be the recurrence of symptomatic or asymptomatic atrial~     fibrillation, documented by an ECG or an R-test, occurring between M3 and M24~        -  Number of patients:~           170 patients will be enrolled in the study~        -  Number of centers:~      Four French and three German centers will participate.~        -  Perspective:~      The demonstration of a clinical benefit in terms of atrial fibrillation risk reduction in the~     patient group with pulmonary vein isolation, could lead to a modification of atrial~     arrhythmia treatment indication.~   "
156173|NCT01521975|"~     Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an~     individualized telbivudine treatment roadmap strategy designed to achieve optimal viral~     suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes~     adding ADV treatment at different time points according to individual patient response. China~     CHB Guidelines (China Medical Association 2010) make impress on and confirm LDT ROADMAP~     strategy particularly, which may be a large potential to expand the naïve patients. We are~     lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total CHB patients. In~     GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA <7log showed a good 2 year~     efficacy, but we still look forward to more efficient treatment and lower resistance rate.~     This study complies with the principle of individualized therapy recommended and ethical~     principles. It is expected that this study design with individualized treatment approach may~     improve efficacy and lower the resistance rates. In addition, it will provide important~     information on how to bring greater benefits to patients with CHB.~   "
156174|NCT01521962|"~     To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in~     patients with diabetes when used in combination with insulin.~   "
156175|NCT01521949|"~     Men who have Prostate Specific Antigen (PSA) recurrence with low PSA levels and long doubling~     times do not require immediate treatment with androgen deprivation therapy and may be safely~     observed. In these situations where current treatment options may cause more unnecessary side~     effects than anticipated benefit, it is reasonable to use a low-risk natural product such as~     Acai Juice Product with antioxidant properties to evaluate whether there are any anti-cancer~     effects.~   "
156176|NCT01521936|"~     This partially randomized phase II trial studies the side effects and best way to give and~     best dose of cholecalciferol in treating patients with acute myeloid leukemia (AML)~     undergoing intensive induction chemotherapy. Cholecalciferol may help improve the outcome of~     patients with AML undergoing intensive chemotherapy~   "
156177|NCT01521923|"~     This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in~     combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055~     Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low~     Disease Activity at Week 52 in study RA0055 Period 1.~   "
156178|NCT01521910|"~     The purpose of the investigators study was to determine the effect of dietary protein~     restriction on survival and progression to end stage renal disease (ESRD) in diabetic~     nephropathy.~   "
156179|NCT01521897|"~     This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3)~     factors affecting safety in terms of the safety in infants starting to receive Prevenar at~     the age of more than 2 and less than 7 months in routine medical practice.~      This surveillance will specifically focus on the occurrence of the following:~        1. Local reactions at the injection site~        2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)~   "
156180|NCT01521884|"~     People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL.~     In this study we are measuring the impact of SC biologics on these parameters.~   "
156181|NCT01521871|"~     By means of a prospective, randomised trial the investigators want to examine skin closure in~     living donors - subjected to laparoscopic, hand-assisted nephrectomy - by tissue glue~     (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1;~     30 + 30 donors).~      Study hypothesis: (i) Latest generation tissue glue (Cyanoacrylate (Liquiband)) is at least~     as good as conventional suture regarding wound healing/complications. (ii) Peroperatively,~     tissue glue is faster than conventional suture.~   "
156182|NCT01521858|"~     Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial~     blood loss. The investigators will investigate the relationship between the various~     hematologic variables and postoperative bleeding volume.~   "
156183|NCT01521845|"~     The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac~     necrosis(CKMB and troponin I) and inflammation marker CRP.~   "
156184|NCT01521832|"~     This is a trial in healthy volunteers to study the safety, tolerability and pharmacokinetics~     of single and multiple escalating doses of SEN0014196.~   "
156188|NCT01521780|"~     The purpose of this study is to characterize the baseline variability of a panel of tissue~     (tumor and adjacent) and blood-based biomarkers obtained from participants with~     hepatocellular carcinoma (HCC). The primary hypothesis is that the upper bound of the 80%~     Confidence Interval of log beta-catenin protein or messenger RNA (mRNA) expression from one~     core needle biopsy (CNB) equivalent is =< 0.65.~   "
156189|NCT01521767|"~     A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two~     Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial~     Extended Release Capsules~   "
156190|NCT01521754|"~     The purpose of this observational registry is to evaluate the long-term effectiveness, safety~     and performance of market-released Medtronic Neuromodulation products for Deep Brain~     Stimulation (DBS) for the treatment of refractory epilepsy. In addition, healthcare resource~     use and patient reported outcomes, such as health related quality of life will be assessed.~   "
156191|NCT01521741|"~     The objective of this study is to determine the level of symptoms, functional disability, and~     changes in quality of life that breast cancer patients experience from changes in their~     arm(s) during and after treatment for breast cancer. These problems are often associated with~     transient or chronic lymphedema, numbness, reduced shoulder flexibility, and an altered~     ability to use the arm for functional activities of daily living. The goal of this study is~     to collect data to support the hypothesis that swelling and other impairments in the upper~     extremities, causes a significant level of symptoms, functional disability and diminished~     quality of life for patients. Furthermore the investigators hope to evaluate how symptoms in~     the upper extremity (such as decreased functionality, sensory changes, pain or stiffness) are~     related to early, low volume lymphedema.~   "
156192|NCT01521728|"~     The first questions asked by patients with a new diagnosis of Amyotrophic Lateral Sclerosis~     (ALS) often include: Does exercise help slow the progression of the disease?, Is there any~     harm in exercising?, or What type of exercise (endurance or resistance) is most~     appropriate? At this time, however, there is a lack of answers for people who suffer from an~     illness that affects their strength above all else. Yet the beneficial effects of exercise in~     both healthy people as well as people with other diseases have been extensively studied and~     resulted in recommendations about the types of exercise that are beneficial. In this study~     the investigators will ask participants with ALS to exercise in one of three ways:~     weightlifting (resistance exercise), stationary bicycling (endurance exercise), and range of~     motion exercise (the current standard of care for ALS patients). The investigators will use~     several different types of tests to determine whether one type of exercise is tolerated~     better and is safer than another. The investigators will also collect information about how~     the body responds to exercise in ALS. This study will help in the development of a larger~     national study to understand how exercise can be combined with other treatments to~     potentially improve strength and alter the course of the disease.~   "
156193|NCT01521715|"~     Patients with advanced renal cell carcinoma (RCC) are classified according to Memorial~     Sloan-Kettering Cancer Center (MSKCC) criteria in three risk-groups: favourable, intermediate~     and poor. To our knowledge there is only one study which examined the poor risk group (Hudes~     et al.), which led to the approval of temsirolimus in this population. However temsirolimus~     demonstrated a low response rate of 8.6% according to Response Evaluation Criteria In Solid~     Tumor (RECIST) criteria and a Progression free Survival (PFS) of 5.5 months and not all~     patients are suitable for temsirolimus treatment.~      Thus, in clinical routine high-risk patients are also treated with multi Tyrosinkinase~     Inhibitors (mTKI). To date, a prospective data acquisition and control of effectiveness of a~     mTKI-treatment in high-risk patients has not been conducted.~      Pazopanib was recently approved for the first-line treatment of advanced renal cell carcinoma~     in Europe and the USA. In the pivotal Phase III trial only nine patients in the pazopanib~     group were poor risk according to MSKCC risk criteria and no analysis of this subgroup was~     performed. Therefore further data in this group of patients with high medical need is needed.~      Currently there are no well-established predictive or prognostic biomarkers in RCC-mTKI~     treatment. This is one of the most important scientific questions in this field. In addition~     to the clinical endpoints in this study, the comprehensive biomarker program seeks to~     evaluate biomarker candidates and will help to learn more about the effects of pazopanib on~     the human organism.~   "
156194|NCT01521702|"~     The aim of this study is to test the additional value of neoadjuvant chemotherapy to the~     standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).~      This study will be performed in compliance with the study protocol, GCP (good clinical~     practice) and the applicable regulatory requirements.~   "
156195|NCT01521689|"~     Chronic Lymphocytic Leukemia (CLL) is still an incurable disease. However recent advances~     have established correlation between the quality of the response (in particular achievement~     of negativity of minimal residual disease (MRD) and progression free and overall survival.~     That is why MRD negative complete remission (CR) is the current goal in CLL treatment.~      The association of Rituximab fludarabine cyclophosphamide leads to the best response rate~     with 52 to 72% CR in medically fit untreated CLL patients. MRD results in this setting are~     still preliminary and around 50%. However many other situations (unfit, elderly, relapse,~     haematological toxicity leading to early interruption of treatment…) are associated with much~     lower response rate that would be improved by consolidation treatment.~      Monoclonal antibodies are the treatment of choice for consolidation because of sparing marrow~     and targeting CLL cells. Alemtuzumab has been used for this purpose and results confirm~     improvement of CR and MRD negative responses but alemtuzumab induced immunodeficiency lead to~     unacceptable infectious complications. Rituximab monotherapy induces low response rate at~     standard dose regimen. This is at least partially due to shaving of CD20, mechanism by which~     CD20 is lost from the leukemic cells but these cells are not cleared. Using low doses of~     rituximab reduced shaving and allowed CLL cells clearance by the mononuclear phagocytic~     system. Such low doses of rituximab can be administered subcutaneously.~      The investigators then propose subcutaneous low dose rituximab in consolidation to CLL~     patients responding after induction but having not achieved MRD negative CR.~   "
156196|NCT01521676|"~     Research of predictive clinical and biological factors in breast cancer :~      genomic, proteomic, mutation~   "
156197|NCT01521663|"~     The purpose of this study is to determine whether IPX159 is safe and effective in treating~     symptoms of RLS in subjects with Restless Legs Syndrome.~   "
156198|NCT01521650|"~     Longer surgical procedures require intubation and there is a potential risk of contaminating~     the lower airways with pathogenic bacteria from the mouth and oropharynx.~      Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal~     but those do occur among patients, both in those not so sick and patients with more severe~     problems.~      For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral~     care with probiotics and this is a pilot study to explore the possibility of the same kind of~     positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.~      Randomisation~        -  No prophylaxis~        -  Preparation with a probiotic suspension before intubation.~      Cultures~        -  oropharynx~             -  before treatment~             -  after intubation~             -  before extubation~             -  day 1 postoperatively~        -  tracheal secretions~             -  after intubation~             -  before extubation~   "
156199|NCT01521637|"~     Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during~     their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on~     one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an~     attenuated loss in muscle fiber size.~   "
156200|NCT01521624|"~     Oxidative stress plays a key role in the pathogenesis of diabetes complications. Chronic~     hyperglycemia and disturbed lipid regulation commonly seen in diabetes are the main causes of~     this process. Despite the critical role of oxidative stress in diabetes, most clinical trials~     with available antioxidants and vitamins have either failed to show any long term benefits or~     have produced inconsistent results (10-11). There has been growing interest in establishing~     the possible roles of oral hypoglycemic agents including Metformin in reduction of oxidative~     stress. Metformin, the most common prescribed oral medication in type 2 diabetes, lowers~     HbA1c around 1.5%, rarely causes hypoglycemia (compared with insulin or sulfonylureas), has~     relatively few contraindications, its adverse effects are generally tolerable, does not cause~     weight gain, is cheap, and is highly acceptable among patients. Given the long term benefits~     observed with metformin use, a role in modulating oxidative stress is imputable. We designed~     this study to evaluate the actions of metformin on oxidative stress in a group of~     medication-naïve newly diagnosed type 2 diabetes patients.~   "
156201|NCT01521611|"~     To determine whether a radiolabelled antibody that targets the bone marrow (the 'anti-CD66')~     can be administered safely to patients as part of the preparative treatment prior to~     haematopoietic stem cell transplantation ('a bone marrow transplant'). Can the radiolabelled~     antibody be shown to effectively target the bone marrow in these patients. If it can, could~     this result in better outcomes after transplantation.~   "
156202|NCT01521598|"~     Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic~     peripheral neuropathy pain (DPN).~      Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with~     painful diabetic peripheral neuropathy.~      Primary Efficacy Endpoint: The primary efficacy outcome variable will be the time to exit~     from the double-blind phase because of inadequate pain relief.~   "
156203|NCT01521585|"~     The principal aim of this study is to obtain safety and tolerability data when SEN0014196 is~     administered orally over 12 weeks to male and female patients with Huntington's Disease.~   "
156204|NCT01521572|"~     The aim of this study is to assess the bronchodilator response of salbutamol on respiratory~     mechanics of healthy individuals, smokers and COPD with varying degrees of airway~     obstruction.~   "
156205|NCT01521559|"~     This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week~     study to assess the efficacy and safety of Intravitreal Aflibercept Injection~     (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary~     to BRVO.~   "
156206|NCT01521546|"~     Duchenne muscular dystrophy (DMD), the most common muscular dystrophy, leads to skeletal and~     cardiac muscle damage. Treatment of pulmonary complications has improved survival; however,~     heart muscle disease or cardiomyopathy has emerged as a leading cause of death, typically by~     the third decade. Although myocardial changes begin early, clinically significant heart~     disease is rarely detected in the first decade of life. Consequently, DMD cardiomyopathy~     frequently goes unrecognized (and untreated) until advanced (and irreversible).~      Current DMD cardiovascular care guidelines recommend beta-blockers and angiotensin converting~     enzyme inhibitors (ACEIs) when decreased ejection fraction (EF) is noted by echocardiography~     (echo); however, this strategy has not significantly improved outcomes. Our team has recently~     made a breakthrough in a mouse study, showing in a model that causes the same heart muscle~     disease in humans with DMD adding an old medicine traditionally used for high blood pressure~     and late-stage heart failure can actually prevent heart muscle damage. Because of this drug's~     proven safety in both children and adults, it is ready to be studied immediately in an RCT in~     patients with DMD to hopefully show, as we did in mice, that we can prevent the devastating~     consequences of heart muscle damage.~   "
156207|NCT01521533|"~     The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in~     combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in~     previously treated patients with multiple myeloma (MM).~   "
156208|NCT01521520|"~     Type 1 diabetes results from the autoimmune destruction of the insulin-producing beta cells~     of the islets of Langerhans of the pancreas. Initially, diabetes is usually clinically silent~     with immune cells invading the pancreatic islets, a process termed insulitis, which~     eventually leads to loss of beta cells in the islets. If enough beta cells are destroyed, the~     body can not make enough insulin to maintain blood sugars in the normal range and clinical~     diabetes develops. The purpose of this study is to assess the ability of magnetic resonance~     imaging with ferumoxytol to detect changes in the pancreas associated with the insulitis of~     type 1 diabetes.~   "
156221|NCT01521351|"~     A prospective study of 700 patients with coronary artery disease will undergo non invasive~     evaluation of their carotid arteries by ultrasound and microwave radiometry. The patients~     will be followed up for 3 years and their outcome regarding the cardiovascular events (death,~     cardiac events, cerebrovascular events) will be recorded~   "
156222|NCT01521338|"~     The goal of this research study is to collect blood and urine samples from people who have~     either the R117H type of CF or the non-G551D gating type of CF to be kept for future~     research.We will also use some of the collected blood to measure the number of neutrophils.~   "
156209|NCT01521507|"~     The study objective is to evaluate the long-term treatment effectiveness for adult patients~     with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the LipiFlow®~     System to a standardized daily warm compress and eyelid hygiene control therapy over a~     duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with other MGD~     and dry eye treatments over a duration of up to 12 Months.~      This is a post-market, non-significant risk, prospective and multi-center clinical trial~     divided into two stages. The first stage from enrollment to 3 Months is an open-label,~     randomized controlled design to compare the effectiveness of a single LipiFlow® System~     treatment to a standardized daily warm compress and eyelid hygiene Control therapy with~     Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage,~     occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness~     of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration~     of up to 12 Months. Subjects are entered into the following subgroups based on the subject's~     self-assessment of the adequacy of symptom relief and protocol-defined criteria for~     additional treatment.~        1. One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.~        2. Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.~        3. Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed by~          other MGD or dry eye treatment, as prescribed by the physician.~   "
156210|NCT01521494|"~     To investigate dose-response efficacy and safety in hemodialysis patients with~     hyperphosphatemia.~   "
156211|NCT01521481|"~     The purpose of this study is to investigate the analgesic efficacy of an ultrasound-guided~     inguinal field block (block of the genitofemoral, iliohypogastric and ilioinguinal nerve).~   "
156212|NCT01521468|"~     A large number of cardiac catheterizations are performed each year, primarily to diagnose~     heart disease. However, a cardiac catheterization is an invasive procedure which is~     associated with serious complications such as heart infarction, stroke, and death. Therefore,~     there is a need for non-invasive procedures to diagnose coronary heart disease. The purpose~     of this study is, therefore, to assess the diagnostic accuracy of non-invasive cardiac~     imaging modalities for the detection of heart disease in patients presenting for the first~     time to the cardiologist with chest pain.~   "
156213|NCT01521455|"~     The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide~     250 Diskus when repeatedly dosed to Asthmatic patients.~   "
156214|NCT01521442|"~     The primary objective of the current study is to establish the safety and acceptability of~     Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD)~     among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)~     Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga~     Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism~     of therapeutic action.~   "
156215|NCT01521429|"~     Approximately 85% of individuals with Mucopolysaccharidosis (MPS) type I, II, or VI report~     weekly pain and 50-60% have significant limitations in their activities of daily living due~     to MPS related musculoskeletal disease despite treatment with enzyme replacement therapy~     (ERT). Thus there is a critical need to identify additional therapies to alleviate the burden~     of musculoskeletal disease in order to improve the health and quality of life of individuals~     with MPS. However, disease progression needs to be quantified to be able to determine~     efficacy of new therapies. This study is a multi-institutional, 5-year, longitudinal study of~     musculoskeletal disease in MPS. The objective is to quantitatively describe the progression~     of skeletal disease and identify biomarkers that either predict disease severity or could be~     used as therapeutic targets in individuals with MPS I, II, and VI. A database of standardized~     measurements of musculoskeletal disease in MPS will allow the field to efficiently move~     forward with therapeutic clinical trials in patients with MPS.~   "
156216|NCT01521416|"~     The objective of this study is to describe the burden associated with influenza in the UK,~     from both primary and secondary care perspectives, and to stratify the burden by the annual~     degree of mismatch between predicted and actual virus strains.~   "
156217|NCT01521403|"~     The objective of this study is to determine whether in the setting of primary health care it~     is effective to treat with metronidazole returning travellers with gastrointestinal symptoms~     and B. hominis in the stool or not.~   "
156218|NCT01521390|"~     GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being~     developed for the treatment of chronic obstructive pulmonary disease (COPD). The long~     duration of action of GSK573719, when administered via inhalation to humans supports the~     potential for use as a long acting bronchodilator.This is a randomized, double-blind,~     placebo-controlled, 5 period cross-over study in healthy male and female volunteers. The~     study will measure lung function after single inhaled doses from two configurations of the~     Novel Dry Powder Inhaler. Key assessments will include clinical relevant PD parameters: sGaw,~     FEV1~   "
156219|NCT01521377|"~     This is a randomized, placebo controlled, four period incomplete block,crossover thorough QT~     study to estimate the effect of repeat dose GSK573719/GW642444M (Vilanterol) combination and~     GSK573719 monotherapy on the QTc interval in healthy male and female subjects compared with~     placebo. At least 100 subjects will receive, four of five possible, 10-day repeat dose~     treatments. Treatments are placebo with a moxifloxacin placebo on day 10, placebo with~     moxifloxacin (400mg) on day 10, GSK573719/Vilanterol combination (125/25μg) with moxifloxacin~     placebo on day 10, GSK573719/Vilanterol combinatio (500/100μg) with moxifloxacin placebo on~     day 10, or GSK573719 (500μg) with a moxifloxacin placebo on day 10. All treatments are double~     blind except for moxifloxacin (400mg) and moxifloxacin placebo controls, given as a~     single-blind single dose on Day 10 of the appropriate treatment period.~      Primary endpoints are individual time-matched changes from baseline QTcF for~     GSK573719/Vilanterol combination (125/25μg) and GSK573719 (500μg), 0-24 hours after dosing on~     Day 10. Secondary endpoints will include individual time-matched changes from baseline in~     QTcF for GSK573719/Vilanterol combination (500/100μg) and moxifloxacin (400mcg) 0-24 hours~     after dosing on Day 10. Also changes from baseline in QTci, QTcB, QT, QRS, RR, PR and~     ventricular rate at each time point after 10 days dosing of each GSK573719 and~     GSK573719/Vilanterol treatment and single dose moxifloxacin (400mg). Maximal change from~     baseline 0-24hours after dosing on day 10 will be derived for QTcF, QTci and QTcB for each~     treatment. Plasma concentrations on Day 10 (0-24 hours) and pharmacokinetic parameters of~     GSK573719 and Vilanterol will also be derived. Key assessments: 12- lead electrocardiogram~     (ECG), pharmacokinetics. Safety will be assessed by blood pressure, heart rate, clinical~     laboratory safety tests and collection of adverse events (AEs).~   "
156220|NCT01521364|"~     Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA)~     in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis~     (MDR/XDR-TB) due to possible synergistic activity as shown in in vitro experiments in~     different Mycobacteria strains. The investigators observed increased LIN serum levels in~     three cases after combining LIN and CLA of which the investigators described one in a case~     report (Bolhuis et al). The investigators suggest to conduct a prospective pharmacokinetic~     study in MDR- and XDR-TB patients to quantify the above described interaction between LIN and~     CLA.~   "
156223|NCT01521325|"~     This research is being conducted to determine the biodistribution of radiolabeled amatuximab~     in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including~     mesothelioma, pancreatic, ovarian or non small cell lung cancer.~   "
156224|NCT01521312|"~     Glucose ACCES study will explore the acute and long term (12-week treatment) effects of~     saxagliptin in patients with impaired glucose tolerance during fasting and after a~     standardised breakfast. The investigations will be performed on:~        -  glycemic parameters~        -  on cardiovascular parameters~   "
156225|NCT01521299|"~     This is an open label Phase I study with two parts. Part Two with SCH900776 in combination~     with hydroxyurea will not be pursued at this time.~      Part One investigates monotherapy with oral hydroxyurea. The primary objective is to~     determine whether a tolerated dose (TD) of hydroxyurea as a single agent can increase the~     percentage of tumor cells in S and G2 phase of the cell cycle. For this reason, all patients~     in Part One must have a tumor lesion accessible for a skin punch biopsy. Tumor biopsies will~     be obtained on two separate occasions: prior to hydroxyurea and at 16-18h after starting~     hydroxurea therapy on day 1 only.~      A baseline 12-lead ECG will be obtained from each study participant. Single-agent hydroxyurea~     will be administered on days 1, 8 and 15 of a 28 day cycle, for ONE cycle only. On these days~     oral hydroxyurea will be started in the late afternoon and administered every 4 hours for a~     total of 6 doses.~      Venous (up to 10 mL) blood samples will be obtained at time zero (pretreatment), 30 min, 1h,~     1.5 2, 2.5, 3.0, 3.5 and 4h following the first oral dose of hydroxyurea, and pretreatment~     and at the same times following the sixth oral dose of hydroxyurea (i.e., 20, 20.5, 21, 21.5,~     22, 22.5, 23, 23.5 and 24 h).~   "
156226|NCT01521286|"~     The purpose of this study is to collect data on the incidence, complications and impact on~     quality of life of herpes zoster (HZ) disease in adults >=50 years of age in Spain. This~     study will also collect data on costs related to the HZ disease, especially postherpetic~     neuralgia (PHN)~   "
156227|NCT01521273|"~     Iron deficiency and iron deficiency anemia are among the major health problems in the~     developing world. Women of childbearing age as well as children are the most vulnerable~     population groups. In Rwanda, more than 40% of the population is estimated to be anemic. A~     promising approach to combat iron deficiency in Rwanda is biofortification of beans. The~     average consumption of beans is about 150 g per person per day in Rwanda and beans are a~     major staple food. Traditional plant breeding has increased the iron content of certain bean~     varieties from about 5 to 11 mg/100g. Iron absorption from beans however is with about 2-3%~     low because of high phytate and high polyphenol contents. A recently conducted study in~     Rwanda showed that the total amount of iron absorbed from a biofortified high iron bean was~     similar to the amount of iron absorbed from a control bean, which had a 50% lower iron~     concentration. This was surprising since the subjects had a low iron status and where~     therefore expected to maximize iron absorption. However, it was concluded that the additional~     iron bred into the bean was not bioavailable most likely due to the strong inhibitory nature~     of phytate in the high iron bean. To clarify that, a multiple meal study (iron absorption~     study) in collaboration of the Human Nutrition Laboratory of ETH Zurich and the Medical~     Faculty of the National University of Rwanda is planned. Subjects will receive two different~     bean varieties (normal iron vs. high iron) in combination with other food ingredients typical~     for that region. The bean varieties will be served with native phytate concentration,~     partially dephytinized (50%) or totally dephytinized.~      Subjects will be apparently healthy females of reproductive age (18-30y). Iron absorption~     will be determined by stable isotope techniques.~   "
156228|NCT01521260|"~     Peri-implantitis is an infectious disease that resides in the mucosa surrounding dental~     implants and also affects the supporting bone. Because the number of implants placed in~     everyday clinical practice is continuously increasing, it is reasonable to anticipate an~     increasing prevalence of peri-implantitis. However, from the literature there is very little~     reliable evidence suggesting which could be the most effective interventions for treating~     peri-implantitis.~      The primary objective of this controlled clinical study is to evaluate the microbiological~     effect of decontamination of the implant surface during the surgical treatment of~     peri-implantitis using a chlorhexidine or placebo solution. The secondary objectives are to~     assess both the clinical and the microbiological effectiveness of treatment of~     peri-implantitis.~      It is hypothesized that rinsing of the implant surface using a 0.12% chlorhexidine solution~     does not lead to better microbiological and clinical results compared to rinsing with a~     placebo solution.~      The present study is a double-blind, placebo-controlled, randomized clinical trial.~      Adult patients with at least one endosseous implant in the oral cavity with clinical and~     radiographical signs of peri-implantitis will be included in this study.~      Implants with peri-implantitis lesions will be surgically exposed, followed by mechanical~     cleansing using curettes and gauzes and cotton pellets soaked in saline followed by either 1~     minute of rinsing with a placebo solution (saline with appearance of chlorhexidine) (control~     group) or 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride~     (CPC) without alcohol (Perio-aid®) (test group). After 1 minute of saline rinsing the~     gingival flap will be returned slightly apical (in order to reduce pockets) and will be~     firmly sutured. For both groups the surgery is followed by 2 weeks of mouthrinses with 0,12%~     chlorhexidine + Cetylpyridinium Chloride (CPC) without alcohol (Perio-aid®) two times daily~     during 30 seconds.~      The main study parameter is the microbial composition of the biofilm on the dental implant~     surface. Secondary study parameters are bleeding on probing, probing pocket depth,~     suppuration on probing, microbiological composition of the peri-implant sulcus, radiographic~     marginal bone level on standardized intraoral radiographs, presence of plaque, presence of~     calculus, marginal soft tissue recession implant failure, complications and adverse events.~   "
156229|NCT01521247|"~     Despite the clear and often stated need, a formal transition program does not exist for~     asthma patients as they move from pediatric to adult care in Western Canada. This population~     is not having their health care needs met. The investigators proposed study would evaluate a~     well structured transition program designed to facilitate continuity of care for this at risk~     patient population.~      Primary hypothesis: A pediatric-to-adult asthma transition program will improve the~     asthma-specific quality of life of young asthma patients in the Calgary area over a 1 year~     period.~      Secondary hypothesis: A pediatric-to-adult asthma transition program will improve asthma~     control, decrease asthma exacerbations, and reduce health care utilization in young asthma~     patients in the Calgary area over a 1 year period.~   "
156230|NCT01521234|"~     Regaining independent walking is the top priority for individuals recovering from stroke.~     Thus, physical rehabilitation post-stroke should focus on improving walking function and~     endurance. However, the amount of walking completed by individuals with stroke attending~     rehabilitation is far below that required for independent community ambulation. There has~     been increased interest in accelerometer-based monitoring of walking post-stroke. Walking~     monitoring could be integrated within the goal-setting process for those with ambulation~     goals in rehabilitation. The purpose of this study is to determine the effect of~     accelerometer-based feedback of daily walking activity during rehabilitation on the frequency~     and duration of walking post-stroke.~   "
157220|NCT01508195|"~     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)~     tablets of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of the FDC tablets (canagliflozin and metformin IR).~   "
156231|NCT01521221|"~     The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension~     in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for~     comparison. The investigators will evaluate the subjects while on tilt table for 10 minutes~     and than while mounted from lying down to 70 degrees for additional 10 minutes. Blood~     pressure, heart rate and symptoms will be continuously measured. First study will evaluate~     the blood pressure changes. Second measure will include hand-grip maneuver 1 minute before~     the erect positon. Trans cranial Doppler will assess the intracranial blood flow during the~     position changes.~   "
156232|NCT01521208|"~     The goal of this study is to show the superiority in survival at hospital admittance and in~     neurological outcome on hospital discharge of continuous mechanical chest compression using~     LUCAS device versus manual chest compressions in patients who suffered an out-of-hospital~     cardiac arrest.~   "
156233|NCT01521195|"~     The investigators propose to examine the relationship between DO2 and VO2 in critically ill~     patients requiring an Extracorporeal Membrane Oxygenation (ECMO) machine. This machine can~     provide complete support of heart and lung function. In so doing, the investigators will be~     able to avoid physiologic coupling by increasing DO2 mechanically, by increasing blood flow~     through the ECMO circuit.~      Null Hypothesis:~      Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is not~     associated with an increase in oxygen consumption.~      Alternate Hypothesis:~      Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is~     associated with an increase in oxygen consumption.~   "
156234|NCT01521182|"~     The purpose of this study is to determine whether the regular consumption of the active~     product enhances the immune function, in comparison to the control product.~   "
156235|NCT01521169|"~     The purpose of this study is to investigate the effect of consumption of a drinkable low fat~     fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol~     (LDL-cholesterol) concentration during 12 weeks of product consumption.~   "
156236|NCT01521156|"~     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable~     low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in~     midly hypercholesterolemic people.~   "
156237|NCT01521143|"~     As < 10% of the necessary patients required by the protocol were recruited and the data were~     not intended to support a labeling claim, it was determined that the abbreviated clinical~     study report (CSR) was the appropriate reporting format. No efficacy analyses were performed~     as the trial was terminated early with incomplete enrollment of < 10%.~      The purpose of this study is to determine if an investigational cell therapy called Cvac can~     help epithelial ovarian cancer (EOC) from returning when administered to patients who are in~     complete remission after surgical removal of their tumor followed by standard first-line~     (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo~     leukapheresis for the manufacture of the study agent. After completion of chemotherapy and~     confirmation of remission, patients will enter the treatment phase of the study.~   "
156238|NCT01521130|"~     This project examines how seizures, and abnormal brain activity, affect language skill in~     children with Benign Childhood Epilepsy with Centro-Temporal Spikes (BECTS). BECTS is a~     common type of childhood epilepsy, and while BECTS patients stop having seizures by their~     late teenage years, many studies have shown that these children have language problems that~     may lead to academic and social difficulties. Using standardized language testing, monitoring~     of brain activity, and MRI brain imaging, this project aims to determine what particular~     combination of BECTS symptoms put children most at risk for language problems and whether~     treatment with anti-epileptic medications may be helpful.~   "
156239|NCT01521117|"~     This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and~     muscle rigidity. Current medications for the treatment of PD do not improve gait and balance~     difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls in~     individuals with PD. The mechanism in which this reduction of falls occurs is unclear. The~     investigators study will look at what aspects of gait and balance are improved by the study~     drug. The study drug is not approved to treat PD in the United States or other countries~     because we do not know enough about it.~   "
156240|NCT01521104|"~     Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of~     invasive depth of colorectal neoplasia.~   "
156241|NCT01521091|"~     Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make~     accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be the~     first choice.~   "
156242|NCT01521078|"~     Excessive alcohol consumption in university students continues for be a serious public health~     concern with a variety of negative consequences. There have been a number of different brief~     interventions developed to address this issue among university students. The current project~     will add to this literature by evaluating the use of a personalized feedback intervention~     (www.CheckYourDrinkingU.net; CYDU). Specifically, this trial will examine whether providing~     access to the CYDU will result in short-term reductions in drinking. This issue is important~     as use of these interventions is not a mandatory requirement for university students so the~     issue is whether making materials of this type available leads to any reductions in risky~     drinking. It is hypothesized that students provided access to the CYDU will display greater~     reductions in drinking at a six-week follow-up as compared to students who were not provided~     access to the CYDU.~   "
156243|NCT01521065|"~     The purpose of this study is to confirm the clinical and economic benefits of IRay treatment~     with respect to the number of anti-VEGF injections and frequency of visits during the first~     year after treatment for patients with wet Age-related Macular Degeneration (AMD).~   "
156244|NCT01521052|"~     Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in~     elderly patients suffering from major depressive episode.~      Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above,~     currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil~     (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor~     threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be~     conducted before starting the trial (screening), once a week for the trial duration and one~     month following end of treatment.~   "
156245|NCT01521039|"~     Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).~   "
156246|NCT01521026|"~     This research on cognitive training addresses the following questions:~        1. Does cognitive training lead to improved cognition, functional abilities, psychiatric~          symptoms, treatment adherence, or quality of life in patients with psychoses?~        2. What are the neurocognitive and non-cognitive factors that predict good outcomes~          following cognitive rehabilitation? In addition to verbal learning and memory, immediate~          verbal memory, vigilance, and executive functioning, the cognitive training intervention~          attempted to improve prospective memory ability (i.e., the ability to remember to do~          things in the future, such as take medications or attend a doctor's appointment).~   "
156247|NCT01521013|"~     When patients present with both a chronic disease and depression, family physicians agree~     that treatment and follow-up is more complicated and that patients' health suffers as a~     result. Programs to help depressed patients learn skills to help manage their mood have been~     developed (depression self-care), using workbooks and audio-visual materials. The programs~     show promise, but little is known about how these self-care programs may work for patients~     with depression and chronic disease.~      Researchers are proposing a study to evaluate a depression self-care programme for patients~     age 40 and over who have at least mild depressive symptoms as well as a chronic physical~     illness and who are treated primarily by a family physician. All study participants (250~     patients selected from different family medicine clinics in Montreal) will receive a package~     of depression self-care materials which include the Antidepressant Skills Workbook, developed~     in Canada, available in French and English, and used in several provinces in depression~     self-management programs; a video on depression; a mood monitoring tool; an information~     booklet to give to family members; and information on additional resources (books, internet~     materials, and local community groups). The participants will be assigned to one of two~     groups randomly (like a coin toss): one group will receive the materials only, the other~     group will receive the materials as well as regular telephone support for up to 6 months by a~     trained coach who will answer any questions the participant may have on the materials they~     are working with.~      All participants who agree to be in the study will be interviewed three times: once at the~     beginning of the study, then at 3 months and finally at 6 months. Patients' depression scores~     will be evaluated to determine the effectiveness of the self-care programme with and without~     the support of the coach. Researchers will also look at the effect that self-care may have on~     use and costs of health services, and whether engaging in self-care has an impact on health~     behaviours (like exercise, taking medications correctly and smoking and alcohol consumption).~      All study data will be anonymous; any information that could potentially allow identification~     of a participant will be removed.~   "
156248|NCT01521000|"~     Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet)~     in patients with pre-clinical lymphedema can halt the progression of lymphedema.~      Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to~     measure pre-clinical and clinical lymphedema.~      Tertiary Objective: To determine whether bioimpedance analysis is better than the gold~     standard of volume displacement to measure lymphedema.~      The successful completion of this study will address whether bioimpedance analysis is a~     reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we~     intend to evaluate whether bioimpedance analysis is better than the gold standard of volume~     displacement for measuring lymphedema. And most importantly, we will evaluate whether a short~     trial of compression garments in women identified to have pre-clinical lymphedema can~     actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the~     research and findings of this study, which may have future bearing on the post-operative~     therapeutic management of subjects with pre-clinical lymphedema following axillary surgery.~      Study Design:Randomized, Pilot Study~   "
156249|NCT01520987|"~     To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects~   "
156250|NCT01520974|"~     The purpose of this study is to determine if an oral probiotic tablet taken once a day for~     twelve weeks can decrease the numbers of bacteria that are associated with tooth decay and~     gum disease in a dentally healthy, young adult population.~   "
156251|NCT01520961|"~     Hueter anterior approach as described by Siguier allows an anatomical approach without muscle~     or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty~     (1.5%, Sariali)and seems to allow quicker rehabilitation.~      The investigators hypothesis was Hueter anterior approach allows quicker functional recovery~     after partial hip replacement.~   "
156252|NCT01520948|"~     Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of~     tremor, slowness of movement, and stiffness, leading to progressive disability and loss of~     independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI),~     urgency, and/or nocturia, are common non-motor symptoms that further diminish the already~     compromised quality of life for adults living with PD. Behavioral interventions for UI -~     including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized~     controlled trials and are free of side effects. Exercise-based behavioral therapy for UI~     requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral~     strategy that incorporates the PFME to suppress urinary urgency and prevent UI.~      We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based~     behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI~     severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be~     randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to~     achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month~     follow-up is planned in the treatment group.~      We hypothesize that:~        1. PD participants who are randomized to the exercise-based behavioral therapy group (Group~          A) will report a significant reduction in weekly frequency of UI episodes compared to PD~          participants in the behavioral control group (Group B). The primary outcome, frequency~          of UI, will be measured using a seven-day bladder diary.~        2. Compared to PD participants in Group B, the reduction in UI frequency in Group A will be~          clinically meaningful as measured by a corresponding improvement on questionnaires of~          satisfaction and quality of life as well as a decline in other urinary symptoms~          including urgency and nocturia.~   "
156253|NCT01520935|"~     The study will assess the burden of influenza by age, risk status, vaccination status and~     influenza subtype, in order to create a complete profile of the burden of influenza-related~     morbidity and mortality in United Kingdom from 1996 to 2008.~   "
156254|NCT01520922|"~     This is a Phase II, open label, single arm, multi-centre study investigating the safety and~     efficacy of ofatumumab plus bendamustine in subjects with untreated or relapsed CLL.~      Each subject from the screening phase who is willing to participate in the study and is found~     eligible according to the inclusion and exclusion criteria will enter the treatment phase and~     will receive a maximum of 6 Cycles of study treatment (ofatumumab plus bendamustine). All~     subjects will receive 3 Cycles of study treatment (Cycles 1, 2 and 3). Eligibility to receive~     study treatment for Cycles 4, 5 and 6 will be assessed following the 3rd Cycle. Subjects who~     have achieved at least stable disease with acceptable toxicity following 3 Cycles of~     treatment will be eligible to continue to receive study treatments for a maximum of 3 further~     Cycles. In case of progressive disease, at, or at any time after the start of Cycle 4,~     subjects must discontinue further study treatment and move into the study's follow-up period.~      During the treatment phase, all eligible subjects will be allocated to receive the following~     study treatments:~        1. Subjects with Untreated CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle~          1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in~          combination with up to 6 Cycles of intravenously infused bendamustine (90 mg/m2, Days 1~          and 2, every 28 Days).~        2. Subjects with Relapsed CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle~          1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in~          combination with up to 6 Cycles of intravenously infused bendamustine (70 mg/m2, Days 1~          and 2, every 28 Days).~      The studies primary endpoint is overall response rate (ORR) as determined by Investigator~     evaluation. The ORR is the percentage of subjects achieving an objective response (i.e.,~     partial response or better), using the IWCLL updated NCI-WG guidelines. Response assessments~     are planned at the following time-points: After 3 Cycles of ofatumumab plus bendamustine~     treatment, after 6 Cycles of ofatumumab plus bendamustine treatment and after the last dose,~     if not after 6 cycles, of ofatumumab plus bendamustine treatment.~      Follow-up assessments will be performed every 3 months following the last study treatment.~     The follow-up period will last for a maximum of 3 years. Response evaluation assessments to~     determine subject response or progression will be performed during the follow-up period,~     according to the IWCLL updated NCI-WG guidelines. Following progression, only survival status~     and details concerning the subject's next CLL therapy will be recorded.~   "
156680|NCT01515345|"~     The purpose of this study is to determine the efficacy and safety of a routine individualized~     antiplatelet therapy after coronary stent implantation by evaluating on-treatment platelet~     reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).~   "
156255|NCT01520909|"~     The purpose of this study is to investigate the efficacy, safety and tolerability of~     eltrombopag in children with previously treated chronic immune thrombocytopenia who are~     between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized~     to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will~     enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.~   "
156256|NCT01520896|"~     Study in healthy volunteers to investigate the effects of Ketoconazole on the~     Pharmacokinetics of NKTR-118~   "
156257|NCT01520883|"~     Many patients suffering from asthma are not compliant to their treatment and consequently,~     are not well controlled. Shared decision making intervention has shown an improvement in the~     outcome of patients with chronic disease. The aim of this study is to evaluate decisional~     conflict and to assess decisional needs of adults with asthma.~   "
156258|NCT01520870|"~     This multicenter, 2-stage, open-label, phase II trial aims to assess the efficacy and safety~     of dacomitinib in adult patients with recurrent Glioblastoma (GBM) with EGFR gene~     amplification and/or EGFRvIII mutation.~   "
156259|NCT01520857|"~     The purpose of the study is to assess whether spinal anesthesia is superior to the standard~     general anesthesia or not for patients undergoing transabdominal preperitoneal inguinal~     hernia repair (TAPP).~   "
156260|NCT01520844|"~     A consortium of research teams has studied the immunovirological characteristics of these~     patients:~      The ANRS CO15 ALT cohort The ANRS CO18 HIV Controller cohort the ANRS EP47 VISCONTI study~   "
156261|NCT01520831|"~     This trial is conducted in Europe. The aim of this trial is to demonstrate a difference~     between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic~     insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.~   "
156262|NCT01520818|"~     This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control~     of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30~     treatment.~   "
156263|NCT01520805|"~     The purpose of this study is to determine whether CPI-613 is effective and safe in either~     patients with refractory or relapsed acute myeloid leukemia (AML) or patients with~     myelodysplastic syndrome (MDS) who have failed therapy with a hypomethylating agent (such as~     decitabine [Vidaza] and azacitidine [AZA]).~   "
156264|NCT01520792|"~     Recent works has emphasized that the mechanism of action of paracetamol analgesic depend on~     its metabolism in the body, since a breakdown product of paracetamol, the AM404 is now~     considered the analgesic metabolite of paracetamol suggesting as paracetamol may be a~     pro-drug.~      Indeed, it has been shown that paracetamol may have a deleterious effect, especially in~     vulnerable populations (hepatic insufficiency, elderly). First results showed a very~     significant decrease in sulfatation and gluthatione and increased phase 1 metabolism of~     acetaminophen, which involves enzymes such as cytochrome P450.~      Multifactorial causes, combining nutrition (depletion of sulfur amino acids), increased~     detoxification of toxic metabolites of paracetamol, stress or trauma are discussed to explain~     the results.~      Clinical studies showed a great variability of pain assessment by patients and variability in~     the metabolic response of paracetamol. Genetic factors probably play a role remains largely~     unknown.~      The review of the literature on genetic polymorphism shows the involvement of a number of~     enzymes that are well known, predominantly on the metabolism of acetaminophen liver, but~     without connection with its analgesic effect. This is a critical missing link in the~     understanding of the analgesic effect of paracetamol.~   "
156265|NCT01520779|"~     analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular~     carcinoma within 1 year after radiofrequency ablation.~   "
156266|NCT01520766|"~     A randomized parallel-group clinical pilot study was designed to evaluate the impact of glass~     fiber reinforced composite posts compared to prefabricated titanium posts on long term~     survival of adhesively restored endodontically treated abutment teeth.~   "
156267|NCT01520753|"~     This trial is conducted in Europe. The aim of this trial is to compare two different active~     treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.~   "
156268|NCT01520740|"~     This study will evaluate the effects of baseline collateral ventilation status on outcomes~     following treatment with AeriSeal System in patients with advanced upper-lobe predominant~     heterogenous emphysema.~   "
156269|NCT01520727|"~     The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and~     catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after~     single oral ascending doses.~   "
156270|NCT01520714|"~     The purpose of this study is to determine whether changes in a patient's position affect LV~     capture thresholds in a clinically significant way.~   "
156271|NCT01520701|"~     The investigators hope to get by reduced and delayed acute radiodermatitis following the~     application of dressings to skin hydrogel Hydrosorb®, a reduction in head and neck pains and~     improved quality of life of patients with head and neck cancer treated with concomitant~     radiotherapy.~   "
156272|NCT01520688|"~     Children with mild persistent asthma that have asthma symptoms once or twice a week and use a~     daily controller, while children with mild intermittent asthma rarely have asthma symptoms~     and do not use a daily controller. Inhaled corticosteroids are the standard treatment for~     mild peristent asthma. The purpose of this study is to measure children rate of growth while~     on different inhaled corticosteroids.~   "
156273|NCT01520675|"~     Chronic pancreatitis is a progressive inflammatory disease of the pancreas characterized by~     destruction of pancreatic parenchyma and subsequent fibrosis. Patients with chronic~     pancreatitis can be treated with medical management, endoscopic therapy and surgical~     treatment. Among the various theories of causation of pain in chronic pancreatitis, there is~     theory of ductal hypertension. In this the pancreatic duct obstruction resulting in ductal~     dilatation, ductal hypertension and parenchymal hypertension is thought to be the cause of~     pain. For patients with dilated ducts, ductal decompression is advocated. Ductal~     decompression can be achieved by endoscopy and by surgery. Surgery comprises of lateral~     pancreaticojejunostomy with or without headcoring. Endoscopic treatment includes~     sphincterotomy, dilatation of strictures, removal of stones with or without extracorporeal~     shock wave lithotripsy (ESWL) and stenting. The pros and cons of endoscopic versus surgical~     therapy are debated. Lateral pancreaticojejunostomy relieves chronic abdominal pain in~     65%-93% of patients. Morbidity and mortality rates are generally low, averaging 20% and 2%,~     respectively. Long-term follow-up of patients after lateral pancreaticojejunostomy reveals~     that up to 50% of patients develop recurrent symptoms and 10%-35% fail to obtain pain relief.~     Studies indicate that more than 60% of patients undergoing pancreatic endotherapy are pain~     free 1 year after the procedure. There are only two randomized controlled trials comparing~     endoscopic treatment with the surgical therapy. In this study the investigators will be~     conducting a randomized trial, to compare endoscopic and surgical treatment of chronic~     pancreatitis. Outcome variables measured in the study will include pain relief, quality of~     life, morbidity, mortality, length of hospital stay and changes in pancreatic function.~   "
156274|NCT01520662|"~     Building upon our experience with a very sophisticated preventive services prompt and~     reminder system, the Preventive Services Reminder System (PSRS), the investigators propose to~     conduct a systematic three-year study with the following aims:~        1. To develop, field test, and refine an Internet-based patient Wellness Portal linked to~          PSRS to facilitate patient-centered, preventive care in primary care practices;~        2. To determine the impact of the Wellness Portal on the process of patient-centered~          preventive care by examining the behavior and experiences of both patients and providers~          and the degree to which recommended services are individualized; and~        3. To develop model Wellness Portal practices and disseminate the Wellness Portal~          technology and knowledge derived from Aims 1 and 2 findings.~   "
156275|NCT01520649|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation in depressed~     human subjects study.~   "
156276|NCT01520636|"~     This study is designed to observe the respective effects of 2 types of physiotherapy early~     after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered~     (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative~     physiotherapy aiming at preventing complications.~   "
156277|NCT01520623|"~     Allogeneic haematopoietic stem cell transplantation (HSCT) often remains the only curative~     treatment for haematological malignancies. The anti-leukaemic effect of allogeneic HSCT,~     called the GvL (Graf-versus-Leukemia) effect, is often associated to the development of an~     immune response against healthy recipient cells leading to a graft-versus-host disease (GvHD)~     in 20 to 70% of allogeneic HSCT. Acute GvHD, that usually targets the skin, the~     gastrointestinal (GI) tract and the liver, is an important cause of morbidity and mortality~     after allogeneic HSCT, particularly in the case of GI GvHD. The main goal of the research in~     the field of allogeneic HSCT is to determine strategies that could decrease the risk of GvHD~     without affecting the GvL effect. According to GVHD experimental models, it is likely that~     GvL but not GvHD may occur in the absence of inflammatory signals induced by the~     transplant-associated conditioning. Based on this hypothesis, we have chosen to analyse the~     role of Complement system in patients who received allogeneic HSCT. Indeed, Complement system~     is a major actor of inflammation and in the generation of tissue destruction, both of which~     are involved in the physiopathology of GVHD. Furthermore, it might be a potential target of~     some available inhibitory drugs (purified C1-Inhibitor, anti-C5 antibodies) in a preventive~     or curative manner in such patients. Preliminary data obtained from 34 allografted patients~     in our institution suggest that Complement activation by the classical pathway is correlated~     to the occurrence of GI GVHD. The goal of our current project, in order to confirm these~     preliminary results in a larger series, is to explore Complement system activation in~     patients who received allogeneic HSCT in three Adult Hematology departments in Paris fot two~     years and to correlate the biological results to the clinical events occurring after HSCT.~   "
156278|NCT01520610|"~     This is a case-control association study with multicentric prospective recruitment.~      Tako-TSUBO cardiomyopathy is a new clinical entity mimicking an acute coronary syndrome. It~     is characterized by reversible left ventricular dysfunction that is frequently precipitated~     by a stressful event and most of patients are postmenopausal women.~      Several hypotheses concerning pathogenesis of Tako-TSUBO cardiomyopathy have been proposed,~     but at present, exaggerated sympathetic stimulation is the main hypothesis. However, the~     investigators don't know why some patients with stressful event may present Tako-TSUBO~     cardiomyopathy whereas most of them don't.~      The investigators hypothesize that polymorphisms in the genes involved in the adrenergic~     pathway resulting in greater catecholamine sensitivity would be associated with an increased~     risk of Tako-TSUBO cardiomyopathy.~   "
156279|NCT01520597|"~     Listeriosis is a foodborne infection responsible for severe disease. Three main forms are~     described: septicaemia, central nervous system infections and maternal-fetal infections.~     Available data on the disease, are mostly retrospective and do not provide an accurate~     picture of the clinical / biological / genetic risk factors for the disease, nor identify any~     element to determine which patients are at higher risk of death, severe neurological~     impairment or fetal loss.~      The primary purpose of the study is to identify clinical, biological and genetic risk factors~     for systemic listeriosis and the determinants of listeriosis-associated mortality in the~     setting of a large prospective nation-wide study.~   "
156280|NCT01520584|"~     The vitamin,minerals and amino acid supplementation for 3 months will improve the semen~     parameters,fertilization rate and embryo quality in subfertile men undergoing IVF treatment~   "
156281|NCT01520571|"~     The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide~     better alignment and clinical function? (2) Do computer-assisted TKAs provide better~     survivorship of implants and less complication? and (3) Do correction of the mechanical axis~     of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery~     due to aseptic loosening?~   "
156282|NCT01520558|"~     This is a multi-center, open-label, non-controlled, non-randomized dose-escalating Phase 1~     clinical study designed to examine the safety of infusing escalating doses of~     CNDO-109-Activated Allogeneic Natural Killer Cells-(from a first or second degree relative),~     after a preparatory chemotherapy regimen, in adult patients with acute myeloid leukemia (AML)~     who are in their first complete remission at the time of enrollment, are not candidates for~     stem cell transplant, and are considered to be at high risk for recurrence.~   "
156283|NCT01520545|"~     Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump~   "
156284|NCT01520532|"~     The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral~     lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed~     using best practices, including optimized procedural techniques and anti-coagulation therapy.~   "
156285|NCT01520519|"~     The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with~     rituximab can help to control CLL and SLL. The safety of this combination will also be~     studied.~      Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer~     cells to die or stop growing.~      Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to~     die.~   "
156286|NCT01520506|"~     The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy~     through the wall of the renal artery to denervate the human kidney.~   "
156319|NCT01520077|"~     Subjects, non pregnant/lactating and over 18years old, with 40% alopecia areata will take~     vytorin (statin/ezetimibe) for 24 or 52 weeks and be monitored for hair regrowth.~      The investigators hypothesize that Vytorin medication may have an effect on the inflammatory~     process of alopecia areata. Inactivating the inflammatory process may help in permitting hair~     regrowth in those subjects.~   "
156681|NCT01515332|"~     This study is simply to test the repeatability of the indirect calorimetry instrument the~     investigators use for our clinical studies.~   "
156287|NCT01520493|"~     Pulmonary artery hypertension (PAH) is a rare, severe disease, characterized by a progressive~     increase in pulmonary vascular resistance ultimately leading to right ventricular (RV)~     failure and premature death. PAH may be idiopathic (IPAH) or may be also related to various~     conditions like portal hypertension, HIV infection, left to right shunt, connective tissue~     diseases such as scleroderma (PAHSSc). Symptoms include dyspnea and fatigue resulting in~     restricted exercise capacity and poor quality of life. The therapies currently approved have~     been shown to improve survival. Indeed, recent studies described a three year survival higher~     than 80%. This improved survival is associated with major challenges for clinicians as most~     patients remain with limited exercise capacity and poor quality of life. A clear~     understanding of exercise physiopathology is thus mandatory to specifically address~     mechanisms responsible for this exercise limitation and eventually improve patients'~     management. In order to better characterize the exercise physiopathology in PAH, the general~     objective of this research is to systematically examine blood flow distribution and limb~     muscles microcirculation at rest and during submaximal exercise in PAH.~   "
156288|NCT01520480|"~     In this study, the investigators analyze a consecutive series of patients operated for~     pathological subtrochanteric femur fracture to describe survival and reoperation rates after~     surgery and to identify risk factors for death. Moreover, the investigators include a cohort~     of patients with non-pathological subtrochanteric fractures for comparison.~   "
156289|NCT01520467|"~     There is currently no drug with pediatric marketing authorization capable of limiting the~     advance in bone maturation of children with aggressive adrenarche. Estrogens are the~     principal actors involved in bone maturation and premature epiphyseal fusion. Aromatase~     inhibitors, used for the treatment of hormone-dependent cancers, block the transformation of~     androgens into estrogens. Third generation inhibitors, of which Anastrozole is one, appear to~     be well tolerated in children and are sometimes used within the framework of clinical trials~     to limit bone maturation and improve prognosis with respect to final size, notably in~     children treated with growth hormone (GH) due to a GH deficit. Nevertheless, the data~     reported are based on small sample sizes and do not include children with pathological~     adrenarche.~   "
156290|NCT01520454|"~     Obese people have elevated levels of the hormone leptin. Despite this, they seem to be~     resistant to the effects of this hormone, which usually regulates appetite and energy~     expenditure. This is similar to what happens with insulin levels in the obese. Furthermore,~     the way lipid ingestion versus lipid infusion may impact novel molecules secreted by tissues~     commonly affected in insulin resistant states such as liver and muscle have not yet been~     studied.~      The aim of the present study is to investigate the effect of oral vs. different doses of IV~     lipid administration on molecular parameters related to glucose and energy homeostasis using~     a randomized, placebo-controlled design.~      Additionally, we will examine how increased free fatty acids (FFAs) my impact intracellular~     leptin signaling such as the STAT3 pathway.~   "
156291|NCT01520441|"~     This is a pilot study examining biological endpoints in men with localized prostate cancer~     who are scheduled to have radical prostatectomies and men with Benign Prostatic~     Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A)~     injection. Patients will serve as their own controls by receiving BoNT-A injections into the~     right peripheral and transition zones and sham saline injections into the left peripheral and~     transition zones.~   "
156292|NCT01520428|"~     The purpose of this study is to evaluate the effectiveness of diabetes management training~     combined with the method of Motivational Interviewing with elements of Cognitive Behaviour~     Therapy and E-mail support in the treatment of type 1 diabetes in adolescents (age range~     13-20 years) compared to a control group. The investigators assess motivational changes and~     effects on metabolic control.~   "
156293|NCT01520415|"~     The objective of this study is to examine the short and long-term effect of myofascial~     trigger point injections with either a local anesthetic or saline in patients with chronic~     low back pain presenting with myofasical pain syndrome.~   "
156294|NCT01520402|"~     The purpose of this study is to determine the importance of genetic differences on~     individuals' response to warfarin in a group of healthy subjects. Warfarin is also known by~     the trade name Coumadin and is in a class of medications called anticoagulants or blood~     thinners. Warfarin works by reducing the blood's ability to make clots. It is used to stop~     blood clots from forming or growing larger in your blood and blood vessels. Warfarin is~     prescribed for many conditions, including for people with certain types of irregular~     heartbeat, people with replacement or mechanical heart valves, people who have suffered a~     heart attack, people who have had orthopedic surgery, or who have a history of having blood~     clots. Warfarin is used to prevent or treat deep vein thrombosis (swelling and blood clot in~     a vein), pulmonary embolism (a blood clot in the lung), and strokes (a blood clot in the~     brain). Researchers have found that certain genes may affect how a person's body will break~     down or react to warfarin. If genetic information can help doctors better determine the best~     dose of warfarin before it is first given, this may help the doctors get patients to the~     correct levels of blood thinning and thereby reduce the risk of bleeding or the risk of~     developing a blood clot. The expectation of this study is that this information will~     ultimately improve warfarin therapy while lessening the risks associated with dosing errors.~     This study is considered investigational because the subjects are healthy and not being~     prescribed warfarin for clinical care.~   "
156295|NCT01520389|"~     This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3~     design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in~     combination with irinotecan.~   "
156296|NCT01520376|"~     This study will try to elucidate wheter the impact of a psychiatric intervention in patients~     hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting at~     1 and 6 month after discharge.~   "
156320|NCT01520064|"~     -  Obtain and analyze medical record data on patients with advanced emphysema who receive~          treatment with the AeriSeal System to better understand safety and effectiveness in the~          post-market setting;~        -  Provide participating physicians access to specified data sets for the purpose of~          generating scientific manuscripts about the effects of AeriSeal System treatment.~   "
156719|NCT01514838|"~     The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C~     as well as its safety in Asian subjects with type 2 diabetes mellitus.~   "
156297|NCT01520363|"~     Dr. Sakkubai Naidu, Principal Investigator, is initiating a double blinded placebo controlled~     clinical drug trial using dextromethorphan (DM) in Rett Syndrome (RTT), at the Pediatric~     Clinical Research Unit (PCRU) of the Johns Hopkins Hospital/Kennedy Krieger Institute.~      It has been shown that receptors for a certain brain chemical called glutamate, in particular~     the NMDA type, are increased in the brain of young RTT patients (<10 years of age). This~     chemical and its receptors, when in excess, cause harmful over-stimulation of nerve cells in~     the brain, contributing in part to the seizures, behavioral problems, and learning~     disabilities in RTT.~      The investigators propose to initiate a specific treatment using DM to counter/block the~     effects of this brain chemical and its excessive receptors to improve the ill effects of~     increased glutamate/NMDA receptors, because of DM's identified ability to block NMDA~     receptors. DM is available for human consumption. Infants and children with respiratory~     infections and cough, as well as non-ketotic hyperglycinemia, are treated with DM, which has~     been well tolerated.~   "
156298|NCT01520350|"~     Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to~     other antipsychotic agents, especially because of its partial dopaminergic agonistic~     activity. Moreover, like the other atypical agents, aripiprazole is an antagonist of the~     5-HT2a receptor, and an agonist of the 5-HT1a receptor. These pharmacological properties~     should enable this molecule to provide antidepressant potentiating capabilities based on what~     has been observed with other compounds sharing similar pharmacological profiles.~      Aripiprazole is now well recognized for its capacity to potentiate antidepressants in the~     treatment of unipolar depression. However, two randomized controlled trials of aripiprazole~     in the treatment of bipolar depression were negative. This surprising result may stem from~     the fact that the doses of aripiprazole used in these studies were rather high (17.6 ± 8.3~     mg/d in study 1 and 15.5 ± 7.5 mg/d in study 2) and could have contributed to inhibit~     dopaminergic activity in key brain areas involved in the modulation of rewards, motivation~     and concentration. Bipolar depression is indeed heavily loaded with general symptoms of~     psychomotor retardation including poor concentration, low energy level, hypersomnolence, and~     hyperphagia. All these functions are modulated by dopamine and strategies aimed at improving~     dopaminergic function are used frequently to resolve residual symptoms of bipolar depression.~      It is expected that aripiprazole used at a more adequate lower dose than in previous studies,~     should be efficacious in the treatment of bipolar type I depression.~   "
156299|NCT01520337|"~     Polyp detection rate in colonoscopy following oral administration of MMX methylene blue~     tablets~   "
156300|NCT01520324|"~     Evaluation of the intraepithelial neoplasia detection rate in patients with long standing~     ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to~     colonoscopy.~   "
156301|NCT01520311|"~     The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph~     (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of~     Duplex Sonography Results and coronary angiography and major cardiovascular or~     cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein~     (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.~   "
156302|NCT01520298|"~     This research study is a prospective, randomized, blinded, placebo controlled trial~     evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip~     fracture patients. IV acetaminophen has received FDA approval. IV acetaminophen does not have~     the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered. All~     patients diagnosed with a hip fracture aged at least 65 years and expected to undergo~     surgical intervention are eligible to participate. Hip fractures affect greater than 300,000~     geriatric patients annually, representing the second leading cause of hospitalization for~     this patient population. Pain control in these patients is often problematic due to~     co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects~     may receive the normal DVT prophylactic treatments post-op.~   "
156303|NCT01520285|"~     This study will be compare Felodipine sustained-release tablets, to Lercanidipine~     hydrochloride tablets (Zanidip®) for the treatment of patients with mild-to-moderate primary~     hypertension and to investigate the influence on patients' heart rate and blood pressure~     variability.~   "
156304|NCT01520272|"~     Background:~      - Cervical cancer is one of the leading causes of cancer death in women worldwide and in~     Uganda. It is caused by the human papillomavirus (HPV). A vaccine against HPV was offered for~     all 10-year-old girls in the Nakasongola district of Uganda from October 1, 2008, to October~     31, 2009. The HPV vaccine requires three doses; however, some girls received only one or two~     doses. Researchers want to compare vaccine immunogenicity in girls who received all three~     doses with those who had only one or two doses.~      Objectives:~      - To examine the immunogenicity (antibody levels) of girls in Uganda who received only one,~     two or three doses of HPV vaccine.~      Eligibility:~        -  Girls who will be at least 12 years old by October 31, 2011, and had at least one dose~          of the HPV vaccine.~        -  All participants will come from the Nakasongola district of Uganda.~      Design:~        -  Participants will have a physical exam and answer questions about their medical history~          and HPV risk.~        -  Participants will provide a single blood sample for testing.~        -  Treatment and vaccines will not be provided as part of this study. Girls who did not~          receive all three doses of the HPV vaccine will be given information about the nearest~          health center. Health centers will provide the missed doses free of charge.~   "
156332|NCT01519908|"~     The purpose of this study is to investigate: the relation of a set of (bio)markers and~     response to Cardiac Resynchronization Therapy (CRT); the interrelationship as well as the~     potential predictive power of these (bio)markers on improvement and/or deterioration of~     cardiac function, cardiac geometry (reverse re-modeling during CRT) will be evaluated.~      (Bio)markers include but are not limited to: collagen, genomic markers, molecular markers,~     electrocardiographic markers, echocardiographic markers, arrhythmogenic markers and markers~     for renal function: blood urea nitrogen (BUN), serum creatinine, glomerular filtration rate~     (GFR).~   "
156333|NCT01519895|"~     The purpose of this study is to assess the effectiveness of the telephone intervention~     program for caregivers of colorectal cancer.~   "
156334|NCT01519882|"~     This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the~     effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and~     night-time movement in bed, in patients with advanced Parkinson's disease.~   "
156305|NCT01520259|"~     Background:~      - Chile has the highest diagnosis and death rates of gallbladder cancer in the world.~     Gallbladder cancer is also the leading cause of cancer death in Chilean women. High rates of~     gallstones and obesity, as well as genetic concerns, may explain these high rates.~     Researchers want to study gallbladder cancer in more depth in Chile. A small study must be~     done to see if a full-scale study is feasible.~      Objectives:~      - To test the methods and procedures of a small-scale study of gallbladder cancer in Chile.~      Eligibility:~        -  Individuals at least 18 years of age who have gallbladder cancer or gallstones, or are~          healthy control volunteers.~        -  Participants will be recruited from four clinical centers in Chile.~      Design:~        -  Participants will be screened with a physical exam and medical history. Because~          gallbladder cancer has a high fatality rate, family members may be asked to provide~          additional medical history information if study participants die or become too ill to~          provide this information.~        -  Participants will provide blood, urine, stool, hair, fingernail, and saliva samples.~        -  Gallstones, bile, and tissue samples will be collected from those who have gallbladder~          removal surgery. Normal and tumor tissue samples will be collected as needed.~        -  Treatment will not be provided as part of this protocol. This is a data collection study~          only.~   "
156306|NCT01520246|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors identify and learn more about biomarkers related to cancer. It may also help~     doctors find better ways to treat cancer.~      PURPOSE: This research trial studies gene expression in samples from patients with T-cell~     acute lymphoblastic leukemia.~   "
156307|NCT01520233|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in RNA and predict how patients will respond~     to treatment. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies gene expression in predicting outcomes in samples from~     patients with high-risk neuroblastoma.~   "
156308|NCT01520220|"~     The purpose of this study is to determine a dose of LY2784544 that may be safely administered~     to participants with myeloproliferative neoplasms.~   "
156309|NCT01520207|"~     Kidney failure can result from a variety of conditions and can be temporary or permanent.~     Hemodialysis is available as a replacement treatment to perform the work that the kidneys~     normally do. However, the dialysis procedure can be associated with rapid changes in the~     composition of the blood - this may lead to changes in blood pressure and in turn reduced~     blood supply to important parts of the body. We aim to investigate if giving a medicine~     (called mannitol) during dialysis may be able to reduce the frequency of these low blood~     pressure events.~   "
156310|NCT01520194|"~     Considering the importance of HPV(human papilomavirus) and related diseases in Brazil, and~     the lack of studies about both the economic and the psychosocial burden of these diseases,~     BEMFAM, a Brazilian non-governmental organization that provides reproductive health services~     and technical support to local governments proposes a study to measure the psychosocial and~     economic burden of genital warts.~   "
156311|NCT01520181|"~     Beta-lactam allergy is the most prevalent drug allergy. Drug eruption is the most common~     symptom whereas life-threatening anaphylaxis is rather rare. A recently published study~     (Journal of Allergy and Clinical Immunology, January 2011, Vol. 127, p. 218-222) described~     the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients,~     disregarding their penicillin skin test results. In the proposed study the investigators will~     similarly challenge beta-lactam allergic patients, both children and adults for an extended~     (5 days) period of time. The study will include patients with a history of a skin rash~     following beta-lactam administration as well as patients who cannot provide any data on their~     presumed allergic reaction, disregarding their penicillin skin test results.~   "
156312|NCT01520168|"~     From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh~     was implanted in an estimated 350,000 patients worldwide.~      The purpose of the study is to evaluate retrospectively the complications related to this~     mesh that occurred in our patients between 2003 and 2005, since new complications continue to~     be diagnosed, although the investigators discontinued the use of the mesh.~   "
156313|NCT01520155|"~     The key of this prospective study is to identify a potentially increased cardiovascular risk~     in patients with systemic Lupus erythematodes, with and without renal affection. Three groups~     of patients will be compared.~   "
156314|NCT01520142|"~     The purpose of this study is to evaluate the anti-inflammatory properties of JNJ-26528398~     using an intravenous (IV) endotoxin-induced model of acute, transient inflammation.~   "
156315|NCT01520129|"~     The investigators propose to conduct a 20 week open pilot study of Interpersonal and Social~     Rhythm Therapy (IPSRT) to treat individuals (n=18) with subthreshold bipolar (BP) who are~     currently depressed. The investigators will conduct a preliminary evaluation of sleep-wake~     and social rhythm patterns in study participants using questionnaires and actigraphy. Primary~     aims of this study are to evaluate feasibility of this treatment and assessment approach.~     Exploratory aims are to examine 1) sleep-wake and social rhythm patterns in subthreshold BP,~     2) impact of IPSRT on symptoms and functioning over time and 3) relationship between~     sleep-wake and social rhythm patterns and treatment outcomes.~   "
156316|NCT01520116|"~     This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary~     efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or~     latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the first~     portion, approximately 75 subjects will be randomized to receive either ATS907 or vehicle eye~     drops for up to 28 days, administered both once and twice daily. In the second portion, up to~     180 subjects will be randomized to receive either ATS907 or latanoprost for up to 28 days.~     Plasma pharmacokinetics will also be evaluated during the first portion of the study.~   "
156317|NCT01520103|"~     The purpose of this study is Examination of the superiority of a combination of vinorelbine~     with the mTOR Inhibitor Everolimus vs. vinorelbine monotherapy for second-line treatment in~     advanced breast cancer.~   "
156318|NCT01520090|"~     Starting from Jan 2012 for an interval of 4 months with minimum number of 1200 egyptian women~     will be asked to complete a questionairre to evaluate their knowledge of different~     contraceptive methods~   "
195881|NCT00999414|"~     This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib~     to patients with relapsed or resistant refractory multiple myeloma.~   "
156321|NCT01520051|"~     Asthma is a chronic inflammatory disorder of the airways characterized by lower respiratory~     tract (LRT) symptoms such as wheeze, cough and airway obstruction. Patients with asthma~     frequently suffer from exacerbations, which can be triggered by allergens and, in particular,~     viral respiratory infections. It has recently been shown that mepolizumab, a humanized~     monoclonal antibody that neutralizes interleukin(IL)-5, markedly reduces the exacerbation~     rate in asthma patients with eosinophilic airway inflammation. Previous studies have~     indicated that in a mixed population (eosinophilic and non eosinophilic) of mild asthma~     patients, mepolizumab did not have an impact on lung function and asthma symptom scores upon~     allergen provocation, although it did on markers such as sputum and blood eosinophils.~     Together, these observations led to the hypothesis that mepolizumab treatment reduces the~     exacerbation rate by limiting virus-induced asthma exacerbations.~      The investigators hypothesize that neutralization of IL-5 during virus infection in patients~     with allergic asthma:~        1. Reduces virus-induced bronchial inflammation~        2. Attenuates virus-induced asthma symptoms, airflow limitation and bronchial~          hyperresponsiveness.~        3. Enhances cellular immune responses to the virus.~      The aims of this study are to:~        1. To investigate whether IL-5 neutralization reduces the inflammatory response to viral~          airway infections in allergic asthma patients~        2. To investigate whether IL-5 neutralization prevents or reduces asthma symptoms during~          virus-induced asthma exacerbations~        3. To investigate whether IL-5 neutralization affects the cellular immune response to viral~          airway infections in allergic asthma patients~   "
156322|NCT01520038|"~     Invasive urothelial bladder cancer is a common malignancy causing 14,000 deaths annually in~     the United States. The primary objective of the feasibility/Phase I portion of the study is~     to establish the feasibility and safety of proton and the safety of IMRT for patients with~     pure or mixed variant urothelial carcinoma.~   "
156323|NCT01520025|"~     Coronary artery disease results in narrowing of the blood vessels supplying oxygenated blood~     to the heart muscle. Diagnosis in patients with symptoms of chest pain is now quickly done~     with CT coronary angiography. This x-ray test can show narrowed blood vessels but has limited~     ability to predict the severity of the narrowings in some cases. We have described a new~     approach using PET exercise 18F-FDG imaging as a method to image areas of heart muscle not~     getting enough blood during exercise stress. The 18F-FDG images are co-registered with the CT~     anatomy from the CTA to provide direct evidence of the consequences of the narrowing.~   "
156324|NCT01520012|"~     The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808~     100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.~   "
156325|NCT01519999|"~     The purpose of this study is to increase colorectal cancer screening by implementing a~     community-wide shared decision-making (SDM) intervention, which embeds shared decision making~     within clinical practice and also uses an extensive community engagement campaign. The~     investigators hypothesize that colorectal cancer screening adherence will be higher in the~     intervention group (participating communities) compared to the usual care control group~     (non-participating comparison communities).~   "
156326|NCT01519986|"~     The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3~     (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal~     associated with the administration of the supplement.~   "
156327|NCT01519973|"~     Single Photon Emission Computed Tomography (SPECT) is a 3D nuclear medicine imaging technique~     that is used extensively to study the heart and diagnose heart disease. There are three major~     limitations in SPECT imaging: attenuation or loss of signal, scattering of the signal in the~     patient tissues and resolution, where the signal gets blurrier the further the nuclear~     activity is away from the camera. New software, Evolution for CardiacTM, by GE Healthcare and~     new cameras with computed tomography (CT) decrease the time needed for images to be obtained~     while maintaining image quality. Evaluation is needed before they become standard of care.~   "
156328|NCT01519960|"~     This parallel group, open label study will evaluate the safety and efficacy of Pegasys~     (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at~     baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and~     without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg~     subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with~     advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment~     with Pegasys. Children in the untreated control Group B who have not experienced~     seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of~     Pegasys treatment. This offer will be available for 1 year following 48 weeks from~     randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed~     up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.~   "
156329|NCT01519947|"~     This comparative, open-label, multicenter, parallel-group study will evaluate the effect of~     altitude on dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to~     achieve a target haemoglobin concentration of 11-12 g/dL in patients with chronic renal~     anemia in pre-dialysis and dialysis. Four groups of patients, at sea level or an altitude~     above 6'000 feet and in pre-dialysis or dialysis, will receive 50-250 mcg Mircera~     subcutaneously according to local label. Anticipated time on study treatment is 36 weeks.~   "
156330|NCT01519934|"~     Up to 120 subjects within the study site's practice who have already had an Ultherapy™~     treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up~     visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each~     follow-up visit.~   "
156331|NCT01519921|"~     This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in~     patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A~     (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180~     micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free~     follow up.~   "
156346|NCT01519726|"~     Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively~     and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2~     years, and substantial weight loss, oral and i.v. midazolam are administered once more and~     blood samples are taken again.~   "
156720|NCT01514825|"~     The purpose of this study is to evaluate the safety and plasma concentration change of YM150~     after repeated administration to healthy elderly male and female subjects.~   "
156335|NCT01519869|"~     This is a prospective study to evaluate the hypothesis that platinum-based neoadjuvant~     chemotherapy followed by interval surgical debulking with platinum-based adjuvant~     chemotherapy is associated with improved maximal surgical cytoreduction rates, comparable~     survival, decreased morbidity, and increased quality of life in patients with International~     Federation of Gynecologic Oncology stages IIIC and IV ovarian, primary peritoneal, or~     fallopian tube cancer when compared to historical controls and to evaluate the hypothesis~     that cancer induced inflammation is a predictor of poor prognosis and response to therapy in~     this group of ovarian cancer patients.~   "
156336|NCT01519856|"~     Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of~     Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is~     unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has~     adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from~     the literature that the antagonistic properties of piribedil are correlated with an~     improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of~     the present non-interventional study is to investigate the safety and efficacy of piribedil~     during long-term therapy of patients with M. Parkinson under consideration of cognitive~     functions and quality of life.~   "
156337|NCT01519843|"~     Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve~     motor learning.~      Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying~     motor learning in healthy volunteers and in chronic stroke patients.~   "
156338|NCT01519830|"~     Depletion of iron stores is frequently observed in regular blood donors, but effects of iron~     deficiency on general health is not well studied. Recent studies in women suffering of~     fatigue suggest iron deficiency without concomitant anemia as a common cause of these~     complaints. Provided the same is true in healthy subjects, substitution of intravenous iron~     might result in an improvement of general well being in iron depleted blood donors.~      Healthy regular blood donors will be screened for low storage iron. Qualifying subjects will~     be invited to participate in a randomized, placebo-controlled trial with substitution of~     intravenous iron or placebo (saline solution). Differences in subjectively felt fatigue and~     other factors of general health and well being will be assessed. If an improvement of such~     factors can be shown after iron replacement, relevant concerns about artificially lowering~     iron stores by repeated phlebotomies will arise and changes of monitoring and substitution~     policies in blood banking might have to be discussed.~   "
156339|NCT01519817|"~     Background:~      - Cancer vaccines are being developed to help teach the body's immune system to attack and~     destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is~     present in some tumor cells, and it can help tumor cells spread to other parts of the body.~     Researchers want to see whether the new Brachyury protein vaccine can help treat people with~     advanced carcinomas.~      Objectives:~      - To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in~     tumor cells.~      Eligibility:~        -  Individuals at least 18 years of age who have advanced cancers that have not responded~          or are no longer responding to standard treatments.~        -  Because the vaccine is made with yeast, people with yeast allergies will not be~          eligible.~      Design:~        -  Participants will be screened with a medical history and physical exam. Imaging studies~          will be used to examine the cancer. Heart and thyroid function tests will be conducted.~          Blood and urine samples will also be collected.~        -  Participants will receive vaccine injections every 2 weeks, for a total of seven visits.~          After seven visits, if the cancer has shrunk or stopped growing, participants will~          continue to have the vaccine about once a month.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Other tests~          will be given as directed by the study doctors. Some participants will have apheresis to~          collect additional blood cells for study.~        -  Participants will continue to receive the vaccine as long the tumor does not start~          growing again and there are no serious side effects....~   "
156340|NCT01519804|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in~     patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC).~     Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on~     Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and~     platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not~     progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as~     maintenance therapy until disease progression or unacceptable toxicity occurs.~   "
156341|NCT01519791|"~     This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in~     combination with Methotrexate (MTX) for inducing and sustaining clinical response in the~     treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active~     Rheumatoid Arthritis.~   "
156342|NCT01519778|"~     Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major~     cutaneous abscess or cellulitis/erysipelas.~   "
156343|NCT01519765|"~     Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue,~     is a widely accepted induction agent, that has been proven safe and effective for induction~     of labor. It stimulates both cervical ripening and uterine contractions, thus making it an~     ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics of~     different administration routes and effects on uterine contractility, side effects, and~     safety. Vaginal misoprostol has been shown to be superior over oral administration however~     patients often prefer a more tolerable route. Buccal administration has already been shown to~     be as effective as vaginal misoprostol for cervical ripening and induction in both first~     trimester and second trimester abortions. There is minimal research comparing buccal versus~     vaginal for third trimester induction of labor. The investigators study is a prospective,~     double blinded, randomized control trial comparing vaginal misoprostol and buccal misoprostol~     in equal dosages of 25 mcg. The investigators seek to answer the question whether buccal~     misoprostol is as effective as vaginal misoprostol for third trimester induction of labor.~   "
156344|NCT01519752|"~     The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is~     effective for the treatment of patients with moderate to severe Tinea pedis.~   "
156345|NCT01519739|"~     The purpose of this study is to evaluate the safety and performance of the MediGuide™ system~     during CRT implants.~   "
156347|NCT01519713|"~     This study is designed to assess the safety and immunogenicity of a single dose of~     Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine~     (SP284) to support registration of the product in Japan.~      Primary Objective:~        -  To describe the seroprotection rate [% of subjects with serum bactericidal assay using~          baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y~          and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of~          age~      Secondary Objectives:~        -  To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years~          of age~        -  To describe the immune responses to meningococcal antigens (serogroups A, C, Y and~          W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.~   "
156348|NCT01519700|"~     The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean~     duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast~     cancer patients.~   "
156349|NCT01519687|"~     The purpose of this study is to determine whether levotofisopam is safe and effective in the~     treatment of hyperuricemia and gout.~   "
156350|NCT01519674|"~     This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical~     trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30~     (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various~     regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or~     without other oral anti-diabetic drugs (OADs)).~      The trial is conducted as a phase 4 trial in the majority of the participating countries.~     However, in some countries the trial is conducted as phase 3b.~   "
156351|NCT01519661|"~     This study assessed the long term safety data for the use of tobramycin inhalation powder in~     patients suffering from cystic fibrosis who have a chronic pulmonary infection with~     Pseudomonas aeruginosa.~   "
156352|NCT01519648|"~     Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute~     leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of~     chemotherapy), and hematopoietic stem cells transplantation.~   "
156353|NCT01519635|"~     The goal of this project is to evaluate the chronic effect (8 weeks) of RASILEZ 300mg~     (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension, and to~     compare the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue oxygenation~     in patients with stage 1-2 hypertension with these effects with those of ESIDREX 25mg~     (hydrochlorothiazide).~   "
156354|NCT01519622|"~     The purpose of this study is to determine the priorities of the elderly in the community~     about end-of-life decisions. To check the perception of the disease in the elderly in the~     community.~   "
156355|NCT01519609|"~     Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major~     single center has docuemted the advantage of using moviprep as bowel prep before~     colonoscopy.This randomised study was conducted to compare moviprep with the present~     standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in~     patients suspected of colorectal cancer, and to investigate number of days where patients~     need to stay home.~   "
156356|NCT01519596|"~     This is a randomized clinical trial that studies symptom-adapted physical activity~     intervention in minimizing physical function decline in older patients with acute myeloid~     leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional~     impairment and improve the quality of life in patients with AML undergoing chemotherapy.~   "
156357|NCT01519583|"~     The WalkMore study will help find out how walking interventions can help overweight/obese~     postmenopausal women with increased risk of cardiovascular disease lower their blood~     pressure.~   "
156358|NCT01519570|"~     Despite the significant benefits of herpes zoster vaccine (HZV), vaccination rates remain~     low. Electronic medical records (EMR) can serve as a practical strategy to better facilitate~     the application of preventative health care, such as increasing immunization rates. A new~     care model that can increase the herpes zoster vaccination rate, as well as other~     preventative health services, is warranted. The objective of this study is to investigate if~     the functions of an EMR, in combination with a pharmacist as part of the care team, can~     improve the herpes zoster vaccination rate.~   "
156359|NCT01519557|"~     The investigators propose to recruit individuals with schizophrenia who are symptomatically~     stable and already taking medications to participate in this study. The investigators will~     recruit 90 individuals with schizophrenia and randomize them to low and high doses of~     DAR-0100A, as well as to placebo. The investigators will have them stay in the hospital for~     several weeks and receive up to 10 doses of DAR-0100A. The investigators will also test their~     cognition before and after receiving DAR-0100A to see if DAR-0100A is helpful and perform MRI~     scans before and after taking the medication to see which areas of the brain are activated~     when DAR-0100A is administered. These tests will be very important because they will help the~     investigators determine whether the D1 receptor is a good treatment target for schizophrenia~     and whether more research and resources should be devoted to finding medications that target~     this system.~      Patients with schizophrenia will be free of other medical, psychiatric and neurological~     disorders including alcohol and substance dependence, and will be able to understand the~     nature of the study and to provide informed consent.~   "
156360|NCT01519544|"~     More than 70% of visitors to high altitude suffer poor sleep. The present study seeks to~     answer the question: Which medication is associated with better sleep at high altitude:~     temazepam or acetazolamide? The investigators hypothesis is that one medication will be~     associated with higher subjective sleep scores than the other. The study will compare the~     sleep quality of 100 subjects as they take either temazepam or acetazolamide during a visit~     to high altitude.~   "
156361|NCT01519531|"~     This is a single-center, randomized, double-blind, placebo-controlled, ascending~     multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics~     of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to~     escalating doses of VIA-3196 or matching placebo. Subjects will be dosed daily for 14 days.~   "
156412|NCT01518855|"~     The primary objective of this study is to investigate incremental cost effectiveness of~     Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of~     essential hypertensive patients.~      To investigate incremental cost effectiveness, primary variables are mean treatment cost and~     achievement rate to target blood pressure level at the end of double-blind treatment period.~   "
156362|NCT01519518|"~     The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the~     performance and subsequent outcomes of Primary percutaneous coronary intervention. This will~     be a pragmatic trial. Interventional procedures will be performed to reflect current and~     evolving standards, including predominant radial access. All patients will be treated with~     routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for~     'bail out' treatment only.~   "
156363|NCT01519505|"~     Public health strategy on type2 diabetes prevention in primary health care. European~     coordinated project (DE-PLAN) adapted to Catalonia (DE-PLAN-CAT). Two-step multicentre cohort~     study: cross-over period (screening) plus a follow-up period (preventive intervention): 12~     centres, 7 working-groups, 42 units, 106 professionals). Interventions: Randomized~     non-invasive diabetes screening program by means of the FINDRISC score comparing with the~     oral glucose tolerance test results. At least one third of the screened subjects is expected~     to present high-risk criteria. They will choose 1 out of 3 interventions to modify lifestyle:~     self-acting vs. individualized or group-based educative (6-hour, 3 or 4 sessions program).~     Participants' motivation will be periodically reinforced. Follow-up will be focused on~     diabetes incidence, cardiovascular risk (HearthScore, Regicor scores), lifestyle-quality of~     life (assessed by European peer-reviewed questionnaires) and cost-effectiveness analysis.~     First-year results includes: protocol, measurement tools and database available, screening~     concluded (n=2082) and European intervention manual on type 2 diabetes prevention started.~   "
156364|NCT01519492|"~     The purpose of the study is to determine the safety, tolerability and effectiveness of~     AFN-12520000 for in the treatment of Staphylococcal infections of the skin.~   "
156365|NCT01519479|"~     The purpose of this study is to assess the impact of palliative care consultation on quality~     of life and symptom management for patients hospitalized with acute heart failure with a~     randomized control trial at Abbott Northwestern Hospital.~   "
156366|NCT01519466|"~     The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood~     glucose meter with a built-in insulin calculator) on glucose control in people with type 1~     diabetes.~   "
156367|NCT01519453|"~     Low-income, minority children are disproportionately affected by asthma and can experience~     higher rates of asthma attacks, lower lung function, decreased physical activity, increases~     in school absenteeism, and higher rates of death. The National Center for Children in Poverty~     suggests that effective interventions to improve asthma and reduce harm for high risk groups~     (like low-income minority children) must begin in early childhood. Previous research has~     shown that asthma education programs can be effective to improve overall asthma management in~     preschool children, but there has been limited sustainability of these programs in medical,~     educational, and social environments that serve young high risk children. One of the core~     missions of federally-funded Head Start programs is to provide preventive health services and~     screening to their low-income preschool students and would be an ideal setting in the~     community to disseminate an early asthma education program. The purpose of this study is to~     draw on our health and research partnership with Baltimore City Head Start programs to test~     the effectiveness of a home-based asthma education intervention combined with a Head Start~     level asthma education program compared to a Head Start level asthma education program alone.~   "
156368|NCT01519440|"~     The purpose of this study is to determine whether a specific surgical technique, blunt~     compared with sharp expansion of the transverse lower uterine incision, is associated with~     risk of unintended extension of uterine incision~   "
156369|NCT01519427|"~     This phase II trial studies how well selumetinib and Akt inhibitor MK2206 works in treating~     patients with stage III or stage IV melanoma who failed prior therapy with vemurafenib or~     dabrafenib. Selumetinib and Akt inhibitor MK2206 stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. It is not yet know whether giving selumetinib and~     Akt inhibitor MK2206 together is an effective treatment for advanced melanoma.~   "
156370|NCT01519414|"~     This randomized phase II trial studies how well tivantinib works compared to placebo in~     treating patients with metastatic prostate cancer. Tivantinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
156371|NCT01519401|"~     The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the~     metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).~      The objective of this study is to compare the effects of a long term administration of two EP~     combinations, containing the same progestin (3 mg drospirenone) and a different dose of~     ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in~     normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group~     A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score~     evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp~     and lipid profile were performed at baseline and after 6 and 12 months of therapy.~   "
156372|NCT01519388|"~     Neuromuscular disorders can be associated with swallowing dysfunction secondary to a~     dysfunction of the airway muscles involved in swallowing. The investigators have shown that~     respiratory failure may contribute to swallowing dysfunction in patients with neuromuscular~     respiratory failure. Furthermore, although tracheostomy has been reported as impairing~     swallowing, the investigators have shown that when a tracheostomy is performed in~     neuromuscular patients, swallowing improves because it allows the patient to feed while~     ventilated.~      The investigators now want to evaluate whether non invasive ventilation may have a beneficial~     impact on swallowing by making some adjustments to ensure a good synchronisation between~     ventilation and swallowing. This could allow avoiding the necessity of a tracheostomy or a~     gastrostomy due to swallowing dysfunction and/or malnutrition in neuromuscular patients.~      Swallowing improvement under mechanical ventilation depends on improving the synchronisation~     between the patient and the ventilator during swallowing. For that purpose, the investigators~     developed a prototype ventilator able to temporarily suspend pressurisation under the~     patient's control so that when the patient needs to swallow under mechanical ventilation he~     may do so with an inadequate insufflation of the ventilator.~      Our objective is to to demonstrate that swallowing is more adapted and easier under nasal~     noninvasive ventilation than during spontaneous breathing in neuromuscular patients requiring~     prolonged noninvasive ventilation.~      In an open monocentric pilot study, the investigators will study 10 neuromuscular patients~     usually noninvasively ventilated. The patients will be their own control and their swallow~     will be studied during spontaneous breathing and under ventilation with the adapted~     ventilator while swallowing boluses of different volumes.~   "
156373|NCT01519375|"~     The primary objective of this cross-sectional observational real life study is to investigate~     the patient reported adherence to PPI, when prescribed as prevention of NSAID associated GI~     Ulcers to patients prescribed a NSAID. Patients included have Osteoarthritis, Rheumatoid~     Arthritis or Ankylosing Spondylitis. Adherence will be assessed by patient questionnaires.~   "
156413|NCT01518842|"~     This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem~     cells in patients with ischemic retinopathy.~   "
156374|NCT01519362|"~     Polyacrylamide hydrogel (PAAG) has been used as an injectable filler for soft tissue~     augmentation in different parts of the body , such as face, breast , or even penis for more~     than a decade . However, there are never reports about the application of a large amount of~     PAAG in epicranial aponeurosis to change the contour of the upper cranium accompanied with~     leukocytopenia. This fancy application turned out to be a disaster for the women who suffered~     from leukocytopenia , widespread migration of PAAG, recurrent swelling of the affected~     tissues and temporal pain changing with the temperature and the facial expression .~   "
156375|NCT01519349|"~     The investigators are performing a gene therapy clinical trial in Becker muscular dystrophy~     (BMD) and sporadic inclusion body myositis (sIBM) patients. Both of these conditions have an~     important common feature: loss of ability to walk because of weakness of the thigh muscles.~     The investigators plan to do a gene therapy trial to deliver a gene to muscle called~     follistatin (FS344) that can build muscle size and strength. If successful, the investigators~     can increase the size of the thigh muscle and potentially prolong a patient's ability to~     walk. The gene will be carried into the muscle by a virus called adeno-associated virus~     (AAV). This virus occurs naturally in muscle and does not cause any human disease, setting~     the stage for its safe use in a clinical trial.~      Presently there is no treatment that can reverse Becker muscular dystrophy or sporadic~     inclusion body myositis. Only supportive care is currently possible.~      In this study, subjects with either of these diseases will have shots of the follistatin gene~     injected directly into thigh muscle on one (first cohort) or both legs (2nd and 3rd cohort).~     One hundred and eighty days following the gene delivery, the muscle will undergo biopsy to~     look closely at the muscle to see if the muscle fibers are bigger. Between the time of the~     gene transfer and the muscle biopsy, patients will be carefully monitored for any side~     effects of the treatment. This will include an MRI of the thigh muscle before treatment and~     at day 180 following treatment. Blood and urine tests, as well as physical examination will~     be done on the subjects during the screening visit and on days 0, 1, 2, 7, 14, 30, 60, 90,~     and 180 to make sure that there are no side effects from the gene injections. Sutures will be~     removed 2 weeks post-biopsy.~      Additional blood samples will be collected at 9, 12, 18, and 24 months. Patients will be seen~     at the end of 1st and 2nd years for a physical exam, assessment of muscle strength and~     appropriate blood tests.~   "
156376|NCT01519336|"~     This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential~     drug-drug interactions between darunavir and danoprevir when administered together with~     low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive~     either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all~     subjects will receive darunavir plus danoprevir together with ritonavir for 10 days.~     Anticipated time on study treatment is 20 days.~   "
156377|NCT01519323|"~     This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail~     extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy~     of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly~     diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma~     harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until~     disease progression or unacceptable toxicity occurs.~   "
156378|NCT01519310|"~     The purpose of this study is to see if intestinal bacteria plays a role in choline metabolism~     (a form of choline monitored in this study is called phosphatidylcholine, also known as~     lecithin). This study will help to determine if choline metabolism is affected by short-term~     antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating~     yogurt).~   "
156379|NCT01519297|"~     This study will compare blood vessel and hormone differences between women who have a history~     of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a~     history of uncomplicated pregnancy in the last 10 years. The investigators hypothesize that~     postpartum women with history of preeclampsia will have altered blood vessel function and~     abnormal hormone levels compared with postpartum women with history of uncomplicated~     pregnancy.~      This study will take place over the course of 2 weeks. Each subject will be assessed on a~     fixed low-salt diet and a fixed high-salt diet. Subjects will have 2 non-invasive blood~     vessel imaging tests and fasting blood draws.~   "
156380|NCT01519284|"~     To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics,~     in comparison to placebo and entacapone.~   "
156381|NCT01519271|"~     Mild cognitive impairment, including difficulty with solving problems, planning, attention,~     or recalling information, can be a significant problem for individuals with Parkinson's~     disease. Even mild cognitive difficulties can lead to worse functioning, quality of life,~     depression, and difficulty for caregivers. Thus, ideally treatment at this stage would~     improve both cognitive symptoms and some of the other problems associated with these~     symptoms.~      Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease~     patients little is known about how best to treat it. This study is a 24-week clinical trial~     to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine)~     Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease.~     Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to~     moderate dementia in Alzheimer and Parkinson's disease patients.~   "
156382|NCT01519258|"~     Neurally-Adjusted Ventilatory Assist (NAVA) is a ventilatory mode that uses the electrical~     activity of the diaphragm to control the mechanical ventilator, offering inspiratory~     assistance in proportion to respiratory effort to patients who need artificial ventilatory~     support. It has been shown to improve the interaction between the patient and the mechanical~     ventilator in several clinical situations, but no previous studies have tried to use it for~     patients with a severe type of respiratory insufficiency, called Acute Respiratory Distress~     Syndrome (ARDS). Patients with ARDS benefit form a mechanical ventilatory strategy that~     includes low inspiratory volumes (tidal volumes) and limited airway pressures, but the~     application of such strategy frequently requires high levels of sedation. The investigators'~     hypothesis is that NAVA can be used for patients with ARDS, and that it will not be~     associated with excessive tidal volumes or elevated airway pressures.~   "
156383|NCT01519245|"~     The goal of this project is to determine whether the use of tranexamic acid, a clot-promoting~     drug, applied topically over the heart in coronary artery bypass graft surgery (CABG) will~     reduce post operative blood loss. The investigators' hypothesis is that the use of a~     tranexamic acid-containing cardiac bath prior to chest closure will result in a statistically~     significant reduction in blood loss and transfusion requirements in patients who undergo~     CABG.~   "
156414|NCT01518829|"~     the value of serum procalcitonin in differentiation between bacterial infection and non~     infectious inflammation in febrile HCC patients following locoeregional treatment for HCC.~   "
156415|NCT01518816|"~     The aim of this study is to detect the association between maternal serum antioxidant level~     and preterm labor.~   "
156384|NCT01519232|"~     Radiation-induced liver disease (RILD) is a syndrome characterized by the development of~     anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. Previous~     studies have shown that both the volume of liver irradiated and the dose of radiation~     delivered are prominent factors for development of RILD. While use of a population-based~     normal tissue complication probability model allows investigators to limit the risk of RILD~     to a clinically acceptable level, a test that permits investigators to determine an~     individual's risk of RILD during the course of treatment may allow for individualized~     treatment modifications, either to prevent toxicity or increase efficacy.~   "
156385|NCT01519219|"~     The goal of the trial is to assess the effect of radiation treatment on liver function as~     determined by indocyanine green extraction. The long term goal is to determine if individual~     assessment of liver function using the IC-Green method, either alone or in combination with~     other factors, will provide Radiation Induced Liver Disease (RILD) risk-estimates that are~     superior to the probabilistic method currently in use.~   "
156386|NCT01519206|"~     The purpose of this study is to evaluate the Ulthera® System for obtaining lift and~     tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or~     submental skin laxity when increased density treatment is applied.~   "
156387|NCT01519193|"~     Street children and children of vulnerable families in conflict or former conflict regions~     are often exposed to multiple traumatic events and situations in which they are forced to~     engage in violent behavior. The Narrative Exposure Therapy for violent offenders (NETvo) aims~     to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful~     experiences and positive emotions linked to violent behaviour in the past. Additionally,~     visions for the future are developed in order to foster successful reintegration into~     society.~   "
156388|NCT01519180|"~     Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even~     nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal~     motility impairement.~   "
156389|NCT01519167|"~     The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric~     population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS)~     for elective diagnostic or therapeutic procedures, expected to take more than 30 minutes.~   "
156390|NCT01519154|"~     Children < 10 years of age often need deep sedation or anaesthesia to allow elective~     diagnostic magnetic resonance imaging; standard routine protocols are~        1. propofol induction without other sedative (Propofol much as needed) or hypnotic drugs~          and propofol infusion 10 mg/kg h~        2. propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed)~          and propofol infusion 5 mg / kg h~      both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI,~     cerebral perfusion/blood flow.~      Hypothesis:~        1. reduces recovery time compared to propofol mono sedation~        2. combination of ketamine-propofol increases incidence of Postoperative nausea and~          vomiting (PONV) compared to propofol mono sedation~        3. combination of ketamine-propofol increases global cerebral blood flow and changes~          regional distribution of cerebral perfusion compared to propofol mono sedation~   "
156391|NCT01519141|"~     This is a longitudinal observational study of HIV-infected patients and HIV-negative control~     patients that is being conducted to learn more about immunologic factors, inflammation, and~     cardiovascular risk in patients with HIV infection or in patients with autoimmune disease.~     The investigators plan to obtain measurement of carotid artery intima media thickness (IMT)~     using high resolution ultrasound as a noninvasive means for tracking atherosclerotic~     progression. The investigators will also measure lipid and lipoprotein levels, inflammatory~     markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic~     lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly~     collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell~     turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count~     and HIV viral load measured in addition. Patients will undergo detailed clinical history~     including HIV disease, specific HIV medications, comorbid conditions, and health related~     behaviors. Physical exam and measurements will be obtained to assess for the presence of~     lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview~     at 4-12 month intervals for the next 3 years.~      Patients will also go assessment of endothelial function, endothelial progenitor cells,~     arterial stiffness as measured using pulse wave tonometry.~      To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV~     positive and negative patients with cardiac disease, the investigators will use 48-hour~     Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history of~     myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery~     hypertension for the presence of cardiac arrhythmia.~      The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography)~     will be used to detect and quantify inflammation in the body.~   "
156392|NCT01519128|"~     The purpose of this study is to investigate the effect of steady-state (constant~     concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what~     the body does to the medication) of digoxin.~   "
156393|NCT01519115|"~     Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization~     has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training~     cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to~     be effective in reducing neck pain, restoring cervical spinal function and mobility in many~     types of cervical spine dysfunction. However, the training of stabilizers has not been~     studied in individuals undergoing cervical spinal surgery, even though these individuals~     often have problems with residual pain and weakness after the surgery.~      Purpose: The purpose of this study is to compare the effectiveness of clinical outcomes~     between an early PT intervention and usual care in patients who have undergone anterior~     cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved~     with early PT intervention.~      Methods: This study is a double-blinded randomized clinical trial with a two-factor (2x3)~     research design. The patients following ACF surgery will be randomly assigned in one of the~     two treatment groups: usual care and early intervention. Three outcome measures will be~     collected pre-operative for baseline, and then at 6-week and 12-week post-operative follow-up~     visits, including: (1) deep cervical flexor (DCF) strength as determined by the~     cranio-cervical flexion (CCF) performance test, (2) patient's perceived disability associated~     neck pain as determined by the Neck Disability Index (NDI) questionnaire, and (3) neck pain~     level using the numeric pain rating scale (NPRS). In addition, at 6 and 12 weeks, the global~     rate of change (GROC) scale will be obtained to determine the patient's perception of overall~     improvement as a result of surgery. The investigator performing the outcome measures will be~     blinded to group assignment, and therefore will not participate in treatment. After~     randomization, the usual care group will receive only one visit of PT for post-operative~     instruction. The early intervention group will receive verbal and written instructions for~     posture and training cervical spine stabilizers in addition to the usual care. The early~     intervention group also will be asked to perform these exercises at home and keep a log of~     the exercise.~      Data Analysis: Two 2x3 MANOVAs with repeated measures will be used to examine the differences~     in the CCF strength and the NDI scores between groups and at the three different time frames~     with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to~     compare the differences in the NPRS and GROC data over time and between groups.~   "
156475|NCT01518023|"~     There is evidence that gastrointestinal operations for non weight-losing purposes are~     beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to~     gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for~     colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose~     and hemoglobin A1c concentration.~   "
156721|NCT01514812|"~     This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in~     healthy subjects.~   "
156394|NCT01519102|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The main goal of this project is to assess whether a dual-hormone closed-loop strategy would~     alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D)~     without a significant degradation in post-meal glucose control.~      Each patient will be admitted twice to a clinical research facility. In one visit, patients~     will eat a morning meal accompanied with a matching insulin bolus (depending on the~     carbohydrate content of the meal) and glucose levels will be subsequently regulated using~     dual-hormone closed-loop system. In the other visit, patients will eat the same meal but will~     inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and~     the remaining needed insulin will be delivered based on glucose sensor excursions as part of~     closed-loop operation. If post-meal glucose levels were indifferent between the two visits,~     then this would suggest that carbohydrate counting may not be necessary during closed-loop~     operation as the closed-loop system will give any remaining insulin needed to cover the~     glucose absorbed from the meal. Twelve subjects will be enrolled in this study.~   "
156395|NCT01519089|"~     The main objective of this study is to evaluate the long term safety of CP-690,550 in~     patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis.~     This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10~     mg BID) after 16 weeks of treatment.~   "
156396|NCT01519076|"~     This study is a prospective trial wherein each included subject will receive the experimental~     magnetically enhanced diffusion therapy. It will be conducted on a maximum of ten adult male~     or female patients who meet the inclusion and exclusion criteria and informed consent has~     been obtained. Subjects presenting in the emergency department with acute ischemic stroke and~     are eligible for tPA therapy may be considered for inclusion in the study.~   "
156397|NCT01519063|"~     The purpose of this study is to evaluate the combined effects of the study medications~     naltrexone and memantine on alcohol drinking behaviors. Participants will be randomized to~     receive a combination of these medications over a one week period and then participate in a~     laboratory session. During this session, participants are given an initial drink of alcohol~     followed by the choice to drink up to 12 more drinks over a three-hour period. These~     medications are hypothesized to reduce craving and number of drinks consumed prior to and~     after exposure to the initial drink of alcohol and during the three hour drinking period.~   "
156398|NCT01519050|"~     The aim of the study is to investigate whether a predictive score (combination of several~     validated predictors) better predicts postoperative left ventricular function than any single~     predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation.~      A single center, prospective cohort study~   "
156399|NCT01519037|"~     The aim of this study is to evaluate, in healthy volunteers, the acute modulating effect of~     cinacalcet on the RAAS, the effect of furosemide on parathyroid secretion of PTH and the~     interaction between furosemide and cinacalcet on parathyroid hormone secretion.~   "
156400|NCT01519024|"~     Principles of motor control suggest that breast hypertrophy can lead to sensoriomotor~     alterations and impairment in body balance due to postural misalignment. The investigators~     conducted this study to evaluate the postural control with different sensorial information~     condition in women with breast hypertrophy.~   "
156401|NCT01519011|"~     The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine~     when administered once daily as two 150-mg tablets, including the effect of food, and to~     evaluate the bioavailability of oral azacitidine 300-mg when administered as two 150-mg~     tablets relative to three 100-mg tablets.~   "
156402|NCT01518998|"~     The purpose of this study is to evaluate the antihypertensive efficacy and safety of~     Fimasartan~   "
156403|NCT01518985|"~     This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial~     enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the~     endothelial dysfunction induced by a single cigarette.~   "
156404|NCT01518972|"~     The purpose of this study is to determine whether the drug prazosin is effective for the~     treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).~   "
156405|NCT01518959|"~     Recent data have shown that the inadequate vitamin D status plays a role in the manifestation~     of the haematologic tumors and serum vitamin D level has a prognostic role also as it~     determines the tumor mortality. But data have not proved a causal relationship between the~     inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown,~     whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to~     improve the prognosis and survival.~      In this study the investigators examine the role of the adequate vitamin D substitution in~     the improvement of the outcomes of haematologic disorders.~   "
156406|NCT01518946|"~     The purpose of this study is to determine whether midodrine works against the symptoms of~     orthostatic hypotension caused by being on a tilt table.~   "
156407|NCT01518933|"~     Hepatitis C virus (HCV)-related liver disease is the most common indication for liver~     transplantation (LT). However, LT does not cure the infection, and therapeutic strategies~     resulted in very limited efficacy and tolerability in LT recipients. In view of its~     postulated safety profile, Silibinin seems an ideal drug to be used in the setting of HCV~     recurrent patients after liver transplantation.~   "
156408|NCT01518920|"~     The objective of this study is to examine the safety, tolerability, and effects on hearing~     thresholds of two single doses of PF-04958242 and placebo in subjects with age-related~     hearing loss.~   "
156409|NCT01518907|"~     This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of~     AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite.~   "
156410|NCT01518894|"~     To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242~     administered orally to psychiatrically stable subjects with schizophrenia receiving~     antipsychotic and adjunctive medication.~   "
156411|NCT01518881|"~     This is a phase 1, single-center, placebo-controlled, single-blind, first-in-human,~     single-ascending dose study with additional multiple-ascending dose cohorts in healthy male~     and female volunteers.~   "
156416|NCT01518803|"~     Obesity has a major impact on the development of cardiovascular disease and other related~     conditions and it is of particular concern in children. The prevalence of childhood~     overweight and obesity in Spain is among the highest in the European continent. Childhood~     obesity has been associated with diseases that were thought to apply only to adults, such as~     the metabolic syndrome. Insulin resistance is the most important risk factor in subjects with~     severe obesity, which together with visceral obesity, exacerbates postprandial~     triglyceridemia, increasing cardiovascular risk.~      In this context, the investigators hypothesize that the postprandial lipid metabolism is also~     impaired in obese pre-adolescents, as it is in obese adults. This includes not only~     exacerbated postprandial triglyceridemia, but also impaired levels of inflammation markers.~     In addition, the investigators hypothesize that the lipid and protein composition of~     postprandial chylomicrons and chylomicron remnants are also altered in obese children when~     compared with their normal-weight counterparts, and that these postprandial lipoproteins~     induce foam cell formation differently. The investigators also believe that a~     Mediterranean-style meal can help to normalize the altered postprandial lipid metabolism in~     obese adolescents.~   "
156417|NCT01518790|"~     The investigators propose to conduct a prospective study of a widely used bowel preparation~     regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a~     colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep~     2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the~     cleanout, assess tolerability and acceptance of the regimen, determine an appropriate~     duration to complete the regimen and assess for any electrolyte changes or side effects.~   "
156418|NCT01518777|"~     This is a pilot study to see whether cardiac imaging can be performed using half the standard~     dose of radioisotope.~   "
156419|NCT01518764|"~     Rationale:~      Epidemiological studies have shown that consumption of alcoholic beverages, red wine in~     particular, is associated with less cardiovascular mortality. In addition, there are reported~     beneficial effects of red wine on components of the metabolic syndrome, arguably the most~     menacing cardiometabolic condition facing us due to the unfolding obesity epidemic.~     Beneficial effects have also been reported with other polyphenol-rich food stuff, such as~     cocoa and green tea and points to a beneficial effect which does not seem to be dependent on~     the alcohol content of red wine. Experimental studies with mixed or separate Red Wine~     Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic~     parameters associated with obesity. Most research has focused on resveratrol, a specific~     polyphenol components which is quite specific to red wine and has, at least in animal~     studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial~     function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the~     same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce~      Objective:~      To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function~     (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.~      Study design:~      Randomized controlled trial (double blind).~      Study population:~      Obese (BMI >30); n=30, men or women, aged 18-60 years.~      Intervention:~      Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.~   "
156420|NCT01518751|"~     Symptoms of blood pressure dysregulation, impaired swallowing and digestion are common~     amongst parkinson patients. The overall aim of this study is to examine blood pressure~     regulation and esophageal motility and gastric emptying in Parkinson`s disease (PD) patients.~      The investigators hypothesize that - compared to age-matched controls - PD patients display~     an altered regulation of blood pressure, altered gastroesophageal motility, and delayed~     gastric emptying. These symptoms occur already early in the disease process, but aggravate~     with progression of the disease.~      The investigators will perform a 7-day blood pressure measurement, measurement of central~     blood pressure and pulse wave velocity, assessment of pulse variability, Schellong tests to~     assess orthostatic function, high resolution manometry assessments during swallowing acts,~     and a 13C-sodium octanoate breath test to assess gastric emptying, in 18 PD patients (9 each~     Hoehn&Yahr stages 1,2) and 12 age- and gender-matched healthy controls. Results will be~     interpreted in relation to the severity of PD motor symptoms.~      The investigators anticipate that blood pressure dysregulation and gastroesophageal motility~     disturbances will be present only in PD subjects, but not in matched controls without~     neurological disorders and without any extrapyramidal motor signs. Furthermore, the~     investigators expect to find an association between motor impairment and the severity of~     these autonomic symptoms, however, that according to the Braak staging, subtle disturbances~     must already be present in the early stages of PD.~   "
156421|NCT01518738|"~     The purpose of this study is to understand whether attention training is effective in~     moderating mind wandering.~   "
156422|NCT01518725|"~     The purpose of this study is to evaluate the change in vitamin D status with the change in~     muscular strength and muscular power in highly trained athletes over a 9-month study period.~     The investigators hypothesize that the greatest muscular strength and power gains will be~     demonstrated in the athletes who achieve and maintain a 25(OH)-D > 50 ng/mL (but < 100 ng/mL)~     over the 6 month study duration.~      This hypothesis will be tested by carrying out the following specific aims: Aim 1. to~     determine the extent to which increasing serum 25(OH)D to > 50 ng/mL is associated with~     improved muscular power by assessing specific performance measures (e.g. Vertical Jump Test~     and Wingate test) relative to lean body mass; and Aim 2. to examine the correlation between~     vitamin D status and muscular power over time.~   "
156423|NCT01518712|"~     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)~     tablets of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of canagliflozin and metformin IR.~   "
156424|NCT01518699|"~     The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in~     Healthy Volunteers.~   "
156425|NCT01518686|"~     The purpose of this study is to determine normal values of the visual field (VF), corrected~     for age- and reaction time (RT) using the Octopus 900 perimeter and semi-automated kinetic~     perimetry (SKP).~   "
156511|NCT01517555|"~     This trial is conducted in Europe. The aim of this trial is to to investigate if there is a~     drug-drug interaction between liraglutide and paracetamol (Benuron®) and to investigate the~     effect of liraglutide on post prandial glucose.~   "
156426|NCT01518673|"~     Patients undergoing a computed tomography are exposed to a relatively high dose of X-rays.~     Pediatric patients are known to be very radiosensitive with respect to radiation induced~     cancer. Using the technique of scoring γ-H2AX foci in peripheral blood lymphocytes the most~     important lesions to the genetic material DNA, double strand breaks induced by CT X-rays can~     be detected. The technique will be applied in a multicenter setting for evaluation of~     X-effects induced by a computed tomography examination in a population of pediatric patients.~     To this end a blood sample will be taken from the patients before and after the examination.~   "
156427|NCT01518660|"~     The purpose of this study is to investigate underlying mechanisms possibly explaining the~     beneficial effects of progressive resistance training for people with multiple sclerosis.~   "
156428|NCT01518647|"~     The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in~     patients with long lasting health problems with no known medical explanation, defined as~     multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of~     treatment, a 9-session group therapy and a 1-day workshop followed by an individual~     consultation, and both are compared to standard treatment, which is one single advisory~     consultation. The study includes 180 patients.~   "
156429|NCT01518634|"~     The aim of this study is to test the effect of the tricyclic antidepressant Imipramine in~     patients with longlasting health problems with no known medical explanation, defined as~     multi-organ Bodily distress syndrome (BDS). Pharmacological treatment of patients with BDS~     have never been tested, and Imipramine i low dosage (10-75 mg) has the potential of reducing~     both pain and other symptoms of bodily distress for patients with BDS. Control conditions are~     pill placebo. Study duration is 19 weeks for each of the 140 patients. End point is 13 weeks,~     i.e. after 10 weeks of 25-75 mg study drug.~   "
156430|NCT01518621|"~     To determine if erlotinib given orally along with concurrent whole brain irradiation in lung~     cancer patients with brain metastases improves median overall survival and enhances local~     control compared to those treated with WBRT alone, without significantly increasing the risk~     of side effects or lowering quality of life.~   "
156431|NCT01518608|"~     Induction of anesthesia:~      After 3 minutes pre-oxygenation with 100% oxygen, a blinded dose alfentanil (0,10,20,30,40,50~     or 60 µg/kg, followed by thiopental 4 mg/kg and rocuronium 0.6 mg/kg will be administered~     over 15 sec. Laryngoscopy will be performed 40 s. after injection of rocuronium, with the~     goal being to have the endotracheal tube passed through the patients vocal cords and the cuff~     inflated within the following 15 s . The investigator performing the tracheal intubation is~     blinded to the dose of alfentanil administered.~      Blood samples:~      As part of the study efficacy, blood samples, will be collected prior to induction and 30 s.,~     1 min. 3 min. and 5 min postintubation to determine blood concentrations of alfentanil and~     catecholamines.~   "
156432|NCT01518595|"~     The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is~     the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with~     hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of~     cirrhosis. It is a progressive disease leading to significantly increased mortality. Up to~     date, the only therapeutic option is liver transplantation. The study hypothesis is that~     administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary~     syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS~     according to the ERS task force criteria will be included in this block randomized,~     double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with~     placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8~     weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary~     endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration~     of the study is 2 years.~   "
156433|NCT01518582|"~     This is a prospective clinical study to assess the performance of the prosthesis according to~     a composite success criterion. The clinical and functional results and the patient's quality~     of life up to 24 months of follow-up will also be recorded.~      Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.~   "
156434|NCT01518569|"~     The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin~     inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response~     in cardiac surgery with CPB.~      Serial measurements and analysis of several inflammatory cytokines (bactericidal permeability~     increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac~     injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's~     efficacy.~   "
156435|NCT01518556|"~     The purpose of this study is to determine whether idarubicin dose intensification is safe and~     effective as a remission induction therapy for acute myeloid leukemia.~   "
156436|NCT01518543|"~     There are many ways of performing arthrodesis in the foot and ankle. Dowel fusion is one of~     them.~      The in situ technique was first described by Ottolenghi et al. (1970) and was taken up by~     Baciu and Filibiu (1979). In the technique, they did take the dowel out before turning it.~     The healing process takes place between surfaces of spongious bone. They showed excellent~     results with early weight bearing and healing within 12.5 weeks. Stranks et al. (1994)~     combined the dowel technique with screw fixation and claimed 95 % healing rate within 12.5~     weeks. Others have not found this technique satisfactory in rheumatoid arthritis patients~     (Belt et al. 2001). The results were not compatible to common fusion techniques. The reason~     may be the circular bone gap of at least 1 mm left by the saw blade.~      A new instrumentation and a new staple with a central wedge (ASTUS) avoid this gap and allow~     the dowel to be turned in situ without leaving in position. The staple is introduced into the~     joint line and will compress the dowel surfaces against the surrounding bone. Instruments are~     available to ensure the correct position and length of the dowel, and to rotate it in situ~     before the special wedge staple is introduced.~      Dr Kofoed, the surgeon designer of the ASTUS Staple, has communicated on his first series~     with 83 arthrodesis. The purpose of this study is now to collect and publish data from~     several centers, several users.~      The objective of this study is to obtain the percentage of healing 3 months after an~     implantation of the staple ASTUS.~   "
156437|NCT01518530|"~     The study is intended to examine the safety and efficacy of computerized mobilization of the~     neck for the treatment of patients with chronic neck pain. This is a third continuation study~     aimed at examining the Occiflex Robotic System. This time we will be studying tailored or~     personalized three dimensional movement of the neck.~   "
156438|NCT01518517|"~     Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by~     toxicities including hypersensitivity. Clinical allergy is associated with inactivation of~     asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any~     clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics,~     tolerability and maintain circulating asparaginase activity due to the protective barrier of~     the erythrocyte membrane.~      This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination~     with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without~     known hypersensitivity to L-asparaginase.~   "
156439|NCT01518504|"~     The purpose of this study is to investigate the effect of thoracic spine joint manipulation~     versus a sham intervention on active and passive shoulder flexion (elevation), external~     rotation, and internal rotation range of motion.~   "
156440|NCT01518491|"~     The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction with~     serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and~     soft tissue wounds when compared to a serial wound debridement and irrigation alone in~     patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with~     reticulated open cell foam (ROCF) dressings.~   "
156441|NCT01518478|"~     A new flu vaccine which is injected into the skin instead of into the muscle has recently~     been approved by the Food and Drug Administration for vaccination of the general population~     including patients with atopic dermatitis (AD). This new vaccine has been shown to work as~     well as the vaccine which is injected into muscle when tested in people without atopic~     dermatitis. The primary endpoint of the study is to estimate the variance of the log fold~     change from baseline in HAI antibody titers for non-atopic controls and participants with~     atopic dermatitis without a history of eczema herpeticum (ADEH-), following administration of~     a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.~   "
156442|NCT01518465|"~     This randomized pilot phase II trial studies how well giving dalteparin, lenalidomide, and~     low-dose dexamethasone together works in treating patients with previously untreated multiple~     myeloma. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in~     patients being treated with lenalidomide and dexamethasone for multiple myeloma. Biological~     therapies, such as lenalidomide, may stimulate the immune system in different ways and stop~     cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving dalteparin, lenalidomide, and dexamethasone together may be an~     effective treatment for multiple myeloma~   "
156443|NCT01518452|"~     The main aim of this prospective interventional study is to compare quantitative EEG findings~     and cognitive and neuropsychological test results before and after training with the Cogmed~     JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6~     years. The investigators hypothesize that the children in the study may respond positively to~     the computerized training and improve working memory, but probably to different degrees~     depending on the underlying neurological condition. The investigators also hypothesize that~     training may benefit additional executive functions.~   "
156444|NCT01518439|"~     Inefficient cough is responsible of respiratory complications in neuromuscular patients which~     can lead to hospitalisation and can be life threatening. Techniques enhancing cough~     efficiency are successful in improving the clearance of bronchial secretions and help non~     invasive ventilation efficiency especially in case of acute respiratory failure. Combining~     mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency.~     Therefore the investigators want to compare cough efficiency under different techniques of~     instrumental and manual of cough assistance in order to determine the best combination to~     optimize cough flow.~   "
156445|NCT01518426|"~     The purpose of this study is to compare three different techniques of EEG recording for~     extraction of P300 Evoked Related Potentials (ERPs).~   "
156446|NCT01518413|"~     The purpose of this study is to determine the safest and most effective oral dose~     combinations of sorafenib and irinotecan in pediatric patients with solid tumors, i.e.~     relapsed or refractory.~   "
156447|NCT01518400|"~     The purpose of this study is to develop a mechanism for utilizing the comprehensive clinical~     database of childhood cancer survivors at Childrens Hospital Los Angeles (CHLA) for research~     purposes. Using clinical information obtained from follow-up visits of childhood cancer~     survivors, the database will focus on interventions to improve health status and~     health-related quality of life in childhood cancer survivors. This study allows for~     establishment and analyses of a research database for LIFE survivors by the investigators~     listed herein. Over the last three decades, there has been marked improvement in survival~     following childhood cancer, with 5-year survival rates now approaching 80%. However, the use~     of cancer therapy at an early age can result in complications that may not be apparent until~     years later as the child matures. These resulting complications, called late effects, are~     principally related to the specific therapy employed and the age of the child at the time the~     therapy was administered. Late effects may affect virtually every body system and~     substantially impair quality of life. As many as two-thirds of childhood cancer survivors~     develop at least one late effect as a result of treatment, and approximately one-third have a~     late effect classified as severe or life threatening.~   "
156448|NCT01518387|"~     The purpose of this study is to assess the effect on reduction of serum phosphate and the~     safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing~     continuous ambulatory peritoneal dialysis.~   "
156449|NCT01518374|"~     This protocol is designed to standardize imaging studies using florbetapir F 18 PET to~     provide information on amyloid burden in subjects participating in other studies (companion~     protocol) such as longitudinal studies of aging and studies of biomarkers for~     neurodegenerative diseases.~   "
156450|NCT01518348|"~     To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E.~     Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin,~     Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric~     subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical~     history.~   "
156451|NCT01518335|"~     This research study hopes to determine whether or not platelet rich plasma therapy improves~     healing time of moderate to severe ankle sprain in comparison to standard of care therapy.~   "
156452|NCT01518322|"~     Overall Aim:~      To better understand the diagnostic process for prolonged respiratory events and determine~     the potential role of FeNO in assessing the possibility of asthma as the symptoms etiology.~      Study Objectives:~      The specific objectives of this study are to:~        -  Determine the frequency of ICS prescription for the treatment of non-specific lower~          respiratory symptoms.~        -  Determine the frequency of asthma diagnosis as an etiology for the non-specific lower~          respiratory symptoms.~        -  Explore the value of FeNO in identifying asthma as the etiology of the non-specific~          lower respiratory symptoms.~      Number of Subjects:~      It is anticipated that up to approximately 3,000 patients will be asked to complete the brief~     screening questionnaire that will be used to identify up to approximately 280 eligible~     patients who meet the study inclusion/exclusion criteria during a (approximately) 4 to 6 week~     study enrollment period.~      Reference Product: NIOX MINO®~      Duration of the participants involvement in the investigation: Single Visit~      Performance assessments:~      Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed using the NIOX MINO®~     device according to Instructions for NO measurements which will be provided to each~     Investigative site prior to patient enrollment.~      Safety Assessments:~      The Investigator is responsible for the detection, reporting, and documentation of events~     meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this~     clinical investigation plan from the time of informed consent/assent and during the study~     period.~      Criteria for Evaluation:~      The relationship(s) between FeNO and both the diagnosis of asthma and prescription of ICS~     will be explored by correlation, measures of concordance and logistic modeling.~   "
156453|NCT01518309|"~     This is an open-label extension study to assess the long-term safety and tolerability of~     pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).~   "
156454|NCT01518296|"~     Pelvic organ prolapse is a common disorder that affects 3-9% of adult women. Treatment of~     this disorder varies and includes conservative and interventional treatment.~      Pelvic organs prolapse grading has an important roll in determining the appropriate~     treatment. Developments in this field has led to the development of an agreed method to rate~     the degree of pelvic organs prolapse (POPQ).~      The roll of Urodynamic test is to assess whether there is urinary incontinence and underlying~     cause.~      In Richard C. et al publication, that presented the Pelvic Organ Prolapse Quantification~     (POPQ) method for the first time, there was no reference to the urinary bladder state (full~     or empty) during the examination, hence the investigators are asking to conduct a prospective~     study in order to evaluate the degree of pelvic organs prolapse according to POPQ method~     during urodynamic examination, with a full and empty urinary bladder.~   "
156455|NCT01518283|"~     This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel~     for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with~     Docetaxel.~      The purpose of this study is to evaluate the activity of the weekly administration of~     cabazitaxel as time to progression by PSA at week 12.~   "
156456|NCT01518270|"~     This study will asses epidemiologic changes in eyelash characteristics with increasing age.~   "
156457|NCT01518257|"~     This study will evaluate the efficacy and safety of a single intra-articular (IA) injection~     of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee~     pain.~   "
156458|NCT01518244|"~     The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®~     from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular~     hypertension.~   "
156459|NCT01518231|"~     The purpose of this study is to evaluate the safety and efficacy of autologous peripheral~     hematopoietic stem cell transplantation in ischemic stroke.~   "
156460|NCT01518218|"~     The objective of this study is to evaluate the effectiveness of 1-year administration of~     laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in~     Africa.~   "
156461|NCT01518205|"~     Diabetic foot (DF) is a common, severe and costly complication of diabetes. DF is underlied~     by neuropathy, atherosclerosis of distal arteries and infection, which result in tissue~     ulcers and necrosis. Alterations in microcirculatory function and in blood rheology may~     concur in causing tissue damage.~      In recent years there has been accumulating evidence that LDL apheresis (LA) does not only~     reduce cholesterol but also has a series of pleiotropic effects that improve the~     microcirculation, increasing peripheral tissue perfusion.~      HADIF is a randomized, multicentric, prospective clinical study aimed at assessing the effect~     of LDL apheresis treatment in association with traditional therapy for ulcers, in patients~     with an ischemic diabetic foot ulcer (class I and II Texas Wound Classification System)and~     peripheral vasculopathy not susceptible to revascularization. A total of 132 patients will be~     enrolled. Participants will be centrally randomized to receive traditional therapy alone (TT)~     or in association with LA. TT includes standard medication of ulcers, antiaggregant therapy~     and statins. LA will be performed with HELP system, for a total of 10 sessions in 9 weeks.~     The primary end-point of the study is ulcer healing; secondary endpoints include improvements~     of peripheral oxygenation, resolution of pain, reduction of circulating inflammatory markers,~     cardiovascular events during one year's follow-up.~      This clinical Study has been approved by local EC on 25 may 2011 (Study number 1953).~      TO BE NOTED: since diabetic patients in our Diabetic-Foot UNIT often presented foot ulcers~     more severe than class II Texas, a formal amendment has been submitted to EC for recruiting~     patients with diabetic foot ulcer of class III Texas. The amendment was already approved on 5~     may 2012.~   "
156462|NCT01518192|"~     Background:~        -  While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe~          as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult~          patients with erythema migrans has been assessed only in the USA where the causative~          agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main~          etiologic agents are B. afzelii and B. garinii.~        -  Controversy exists over the significance and even the existence of post-Lyme disease~          symptoms because of the high rate of similar background symptoms in the general~          population.~      Purpose:~      The two main purposes of this European, prospective clinical trial in which doxycycline and~     cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and~     which included a control group to address the significance of post-Lyme disease symptoms are:~        -  To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the~          treatment of erythema migrans using clinical and bacteriological criteria~          (noninferiority testing approach), and~        -  to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM~          with antibiotics and the frequency of similar symptoms in control subjects without Lyme~          disease.~   "
156560|NCT01516918|"~     The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen~     (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with~     cirrhosis.~   "
159862|NCT01473641|"~     This study characterises the frequency of specific insertion-, localization- and~     removal-related events and clinically significant consequences thereof among Nexplanon users~     in the US during routine clinical use.~   "
156463|NCT01518179|"~     Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be~     characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers),~     and grip strength.~      Compression gloves are used to enhance rehabilitation after various clinical conditions and~     injuries. However, there are no reports on the effect of compression gloves following Distal~     Radius Fracture (DRF).~      This study aims to assess the incremental effect of wearing Made-to-Measure Compression~     Gloves on rehabilitation following DRF.~      Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up~     and treatment will enhance rehabilitation, when compared with routine follow up and~     treatment, in patients following Distal Radius Fracture.~      ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal~     Radius Fractures):~      S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of~     lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of~     both ulna and radius: lower end (S52.6), shafts (S52.4).~      S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)~   "
156464|NCT01518166|"~     The trial is conducted in Europe. The aim of the trial is to investigate if there is any drug~     to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril (Zestril®),~     griseofulvin and digoxin (Lanoxin®).~   "
156465|NCT01518153|"~     The goal of this clinical research study is to learn what dose of a kind of immune cell~     called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell~     transplant has the best results. The safety of this treatment will also be studied. This will~     be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple myeloma.~     These results are measured as helping to control the disease without severe graft-versus-host~     disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues of the recipient's~     body.~      Fludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants:~        -  Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells,~          which may cause the cancer cells to die.~        -  Melphalan is designed to bind to the DNA of cells, which may cause cancer cells to die.~        -  Alemtuzumab is designed to weaken the immune system and reduce the risk of rejection of~          the transplant and graft-vs-host disease (GvHD).~      The donor infusion of T-cells is designed to help restore the immune system after the~     transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer~     coming back.~   "
156466|NCT01518140|"~     The goal of this clinical research study is to learn if 3 breathing devices reduce feeling~     short of breath in cancer patients. Researchers also want to learn if these devices can help~     to control shortness of breath.~   "
156467|NCT01518127|"~     The purpose of this study is to evaluate the behavior of intravitreal injection of of~     autologous bone marrow stem cells in patients with age related macular degeneration.~   "
156468|NCT01518114|"~     Exercise training (ET) is highly beneficial in heart failure patients and has been suggested~     to confer significant symptomatic and functional improvements in patients with diastolic~     dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a~     structured ET program in symptomatic HCM patients.~   "
156469|NCT01518101|"~     Dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagonlike peptide-1 (GLP-1) mimetics or~     analogs, which rely on the gastrointestinal hormones that are part of the incretin system for~     the treatment of T2DM, provide a therapeutic alternative to common oral antihyperglycemic~     agents (eg, sulfonylureas, thiazolidinediones). Although GLP-1 analogs and DPP-4 inhibitor~     medications are effective, there are differences between these products, including method of~     administration (injectable versus oral). Previous studies have shown that patients prefer~     additional oral agents over injectable agents because of fear of injections and the desire to~     avoid them. Patient preference is both clinically and financially important, as it can have~     long-term implications in terms of patients' motivation and insight into their disease state~     and its treatment, which might have a direct impact on the patient's compliance and treatment~     adherence. The aim of the current study is to evaluate the proportion of T2DM patients~     preferring oral anti-diabetic treatment with vildagliptin + metformin versus an injectable~     anti-diabetic treatment with liraglutide after 4 weeks of treatment with each medication.~   "
156470|NCT01518088|"~     The purpose of the study is to examine how a dietary fiber affects metabolism in healthy~     overweight and obese adults. The fiber will be added to foods that participants will consume~     for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one~     period, and 30 g per day in the other. In another three-week period, they will consume the~     same foods, but with no fiber added. Major outcomes will include fermentability of the fiber,~     as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The~     caloric value of the fiber will be determined and metabolic measures related to blood glucose~     control and inflammation will also be taken.~   "
156471|NCT01518075|"~     In the investigators' knowledge there are no data about the impact of non invasive mechanical~     ventilation on the breathing-swallowing interaction.~      Our main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive~     Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute~     exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)~   "
156472|NCT01518062|"~     This trial is conducted in Europe. The aim of this trial is to assess whether increasing~     doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and~     improve final height. This trial has two trial periods, a main period of 4 years and an~     extension period until final height is reached.~   "
156473|NCT01518049|"~     The aim of this study is to develop a scale to measure the severity of depression with~     psychotic symptoms (psychotic depression). Furthermore, we hope to detect potential~     biomarkers (substances in the blood) which can aid in the detection of psychotic depression.~      Main hypothesis: A clinically valid rating scale measuring the severity of psychotic~     depression can be developed.~   "
156474|NCT01518036|"~     This trial is conducted in Europe. The aim of this trial is to study the dose-response~     relationship and effect of somatropin (Norditropin®) on final height in girls with Turner~     Syndrome.~   "
156745|NCT01514500|"~     This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability,~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to~     placebo in healthy male subjects.~   "
156476|NCT01518010|"~     This research project aims to find out if a multiplayer online video game can provide~     therapeutic benefit for people who have survived a brain injury.~      Video games provide therapeutic benefits in many contexts (Griffiths, 2005). Players of~     online multiplayer games behave altruistically and form friendships (Wang and Wang, 2008).~     These positive emotional effects may enhance cognitive rehabilitation, because the cognitive~     and emotional sides of rehabilitation are connected (Mateer, 2005).~      The hypothesis is thus: that playing multiplayer online games can be a useful form of~     cognitive rehabilitation for brain-injured people.~      This research will identify whether or not multi-player online video games may be used as a~     complementary therapeutic tool. A further aim is to develop guidelines which would help~     others considering the use of video games for cognitive rehabilitation.~   "
156477|NCT01517997|"~     In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be~     randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm~     will undergo a percutaneous transluminal angioplasty (PTA) with the use of a~     paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES)~     study arm will undergo primary stenting using drug-eluting stent(s). The study's primary~     endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will~     include the immediate technical success,6-month primary patency, target lesion~     revascularization and limb salvage and complication rates.~   "
156478|NCT01517984|"~     The study will compare how well transplanted kidneys work and the response of people's immune~     systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this~     research study will evaluate whether reducing immunosuppression can decrease some of these~     side effects while still preventing rejection of the kidney.~   "
156479|NCT01517971|"~     This research trial studies biomarkers in predicting the risk of cancer returning after~     surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying~     samples of tumor tissue from patients with cancer in the laboratory may help doctors identify~     and learn more about biomarkers related to cancer and predict how well patients will respond~     to treatment.~   "
156480|NCT01517958|"~     The investigators hypothesize that ultrasonography of the newborn lung can be used as an~     effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory~     distress.~   "
156481|NCT01517945|"~     The purpose of this study is to customize and personalize an existing computer-based~     intervention program in order to help breast cancer survivors cope with fears of cancer~     recurrence.~   "
156482|NCT01517932|"~     Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for~     short-term postoperative sedation and analgesia.It can also reduce the stress response~     without respiratory depression.~      In this prospective, randomized, double-blind, placebo-controlled study，we gave~     dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of~     dexmedetomidine on stress response and postoperative analgesia in patients undergoing~     thoracotomy during anesthesia recovery period.~   "
156483|NCT01517919|"~     This study will systematically evaluate a training program in state-of-the-art behavioral~     change approaches and facilitation skills for peer leaders and a peer-led diabetes~     self-management support program designed to be conducted in community and clinic-based~     settings on an ongoing basis.~   "
156484|NCT01517906|"~     The purpose of this research study is to test a new type of counseling developed to decrease~     symptoms of anorexia nervosa and bulimia nervosa and improve health and well-being in women~     with these eating disorders. At this time, the most effective form of treatment for anorexia~     nervosa and bulimia nervosa is cognitive behavioral therapy. However, this form of treatment~     leads to a complete absence of symptoms in only about 50% of persons completing the treatment~     program. In this study we will test the effectiveness of a new form of counseling that~     focuses on identifying and building personal strengths and positive views of the self as the~     means to decrease eating disorder symptoms and improve health. This study will involve 150~     women between the ages of 18 and 35 years who currently have symptoms of anorexia nervosa or~     bulimia nervosa. To participate in this study, women must also be: 1) not pregnant, 2)~     without any other diagnosable mental disorder, 3) not currently taking medications for their~     eating disorder or other mental disorder symptoms, 4) not ill enough to require inpatient~     treatment for their eating disorder and 5) willing to refrain from seeking other treatment~     for their eating disorder for the duration of this study. Each participant will participate~     in a 20-week treatment program that includes nutritional counseling and medical care. Both of~     these forms of treatment are considered by the American Psychiatric Association to be~     essential parts of treatment for eating disorders and have been found help to reduce~     symptoms. In addition, participants will receive one of two types of counseling:~        1. Experimental counseling that focuses on building strengths and positive self-views~        2. Standard counseling that helps the participant identify and solve problems that are~          believed to contribute to their eating disorder symptoms.~      The type of counseling that a participant receives will be determined randomly. To determine~     whether the experimental counseling is effective, eating disorder symptoms, psychological and~     functional health will be measured before the treatment begins and three times after the~     treatment ends (immediately after treatment ends, 6 and 12 months later). The findings of~     this research study are expected to contribute to the development of effective interventions~     to decrease eating disorder symptoms, and increase health and well-being in women with~     anorexia nervosa and bulimia nervosa.~   "
156485|NCT01517893|"~     The investigators purpose is to initiate a phase II, randomized, placebo-controlled clinical~     trial to test simvastatin, an FDA-approved medication for hypercholesterolemia, as a new~     treatment for vitiligo. The aims of this placebo-controlled study seek to determine the~     safety and potential efficacy of simvastatin 80mg daily versus placebo in adult male patients~     with generalized vitiligo. Additionally, the investigators will collect blood to examine the~     effect of simvastatin on autoreactive CD8+ T cells in vitiligo patients.~   "
156486|NCT01517880|"~     GNE myopathy or hereditary inclusion body myopathy (HIBM) is a severe progressive metabolic~     myopathy caused by a defect in the biosynthetic pathway for sialic acid (SA).~   "
156487|NCT01517867|"~     The purpose of this study is to compare the effectiveness of two parenting programs in a~     mental health clinic serving young children with behavior problems.~   "
156488|NCT01517854|"~     The investigators propose the first prospective, double blind, randomized controlled trial of~     treatment for pulmonary arterial hypertension (PAH) related to underlying portal~     hypertension. Specifically the investigators will evaluate the potential efficacy and safety~     of sildenafil (Revatio) in a 16 week blinded, multicentre study.~   "
156561|NCT01516905|"~     The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404~     PET/CT in humans with brain metastases and GBMs. This goal will be accomplished by~     determining the optimal PET/CT protocol and comparing PET tumor uptake to MRI and calculating~     tumor dosimetry. A future aim of this study will be to compare non-invasive PET/CT and MRI~     findings with pathological specimens, which is the gold standard but is invasive and~     impractical in many cases, to determine the sensitivity and specificity of both techniques~     for accurately detecting tumor infiltration. The data obtained from this study will be used~     to develop larger diagnostic and therapeutic trials in brain tumors. The long-term goals of~     this research are to improve the diagnosis and treatment of malignant brain tumors by using~     radioiodinated NM404.~   "
156489|NCT01517841|"~     The purpose of this study is to understand what prevents chronic kidney disease patients from~     making a timely decision about dialysis modality options. This understanding will allow us to~     develop and implement interventions to assist patients in this turning point so that they can~     make the right decision for them in a timely enough manner so that each patient can start~     dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients~     (20% or less of kidney function remaining) will be asked to participate in the study with the~     goal of having 150 patients participate in the study.~      Hypotheses:~        1. 50 % of patients will have made a modality decision when interviewed and patients in the~          action stage of behavior will be more likely to make a modality selection than patients~          in earlier stages of behavior change. Barriers to modality selection will act at several~          levels including patient, provider and health system level and will vary by behavioral~          stage of change~        2. 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD,~          education, and income will likely be barriers to home dialysis choice.~   "
156490|NCT01517828|"~     Anesthesia is rarely used to intubate newborns in delivery room because of the very~     difficulty of accessing veins. The investigators hypothesized that intranasal administration~     of sedative would be an effective alternative. -Midazolam and Ketamine are two drugs used~     during neonates' intubation. They are also used intranasally in the absence of venous~     access-In a pilot study the investigators have demonstrated that sedation with Midazolam was~     effective in 67% of the patients. Efficiency was defined by a specific pain score: FANS < 4~     (Faceless Acute Neonatal Pain Scale) and by an impedancemetric Pain monitor < 0.2 spike/s.~      The investigators hypothesized that intranasal ketamine would increase procedure~     effectiveness from 67 to 90%.~        -  Main objective: To compare newborns sedation quality as they are sedated either by~          intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.~        -  Secondary Objectives: To compare intubation quality, hemodynamic and respiratory~          tolerance, and neurological outcomeat 2 years within the two groups.~   "
156491|NCT01517815|"~     Overweight patients are susceptible to develop acute complications when they are admitted in~     an Intensive Care Unit (ICU). Severe infection can be associated with cardiovascular failure~     ('shock) and is associated with 35-50% mortality. One of the key issue to cure infection is~     to administer antibiotics. However, under dosing antibiotic is one of the main reason that~     explain treatment failure. There are very few data concerning particularities of antibiotic~     dosing in critically ill, overweight, patients. The aim of the present study is to describe~     the pharmacokinetic of two main antibiotics (doripenem and piperacillin/Tazobactam) in both~     overweight and non overweight critically ill patients presenting a septic shock. The~     investigators hypothesis is that usual dose for those antibiotic may be accurate in non~     overweight patients but is not in overweight patients.~   "
156492|NCT01517802|"~     The purpose of this study is to collect follow-up safety data from participants in completed~     abiraterone acetate studies for a maximum duration of 6 years.~   "
156493|NCT01517789|"~     Visual morbidity (visual acuity and/or visual field deficit) must be taken into account~     during neurosurgical procedures for lesions near the optical pathways. Part of this morbidity~     is due to surgical manipulation. There is no validated tool for intraoperative visual~     monitoring and few publications have studied this issue.~      In a preliminary work based on analysis of these publications, we defined technical,~     anaesthetic and analytical parameters in order to optimise intraoperative visual evoked~     potentials monitoring. These parameters are special devices used for transpalpebral~     stimulation, complete intravenous anaesthesia without halogen or nitrous oxide, and pertinent~     analysis criteria of visual evoked potential (VEP). We suppose that these improvements will~     increase reliability of intraoperative VEP.~   "
156494|NCT01517776|"~     The primary objective of this study is to evaluate the efficacy of a combined treatment with~     cilengitide and metronomic oral temozolomide as measured by 6 months overall survival (OS)~     after diagnosis of relapse or tumour progression in children and adolescents with relapsed or~     refractory high-grade malignant glioma and diffuse intrinsic pontine glioma.~      Secondary objectives include:~        1. To evaluate the safety and toxicity of the study treatment by common toxicity criteria~          (CTC; version 4.0).~        2. To assess~             -  the response rates at 6 months (continuous complete response = CCR, complete~               response = CR, partial response = PR, stable disease = SD, progressive disease =~               PD) and~             -  progression-free survival (PFS) at 6 months, and~             -  response rates, OS, and PFS at 12 months after relapse diagnosis or diagnosis of~               tumor progression. Response will be presented including histopathological variants.~        3. To assess the pharmacokinetics of cilengitide administered as part of the study~          treatment.~      Indication and study population for this trial:~      Treatment of relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas~     in paediatric patients ≥ 3 years and < 18 years of age.~      Patients included in the study receive~        -  Cilengitide 1800 mg/m² i.v. twice weekly~        -  Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory~          platelet-count dependent dose adaptation rule: mandatory blood counts twice weekely:~          Platelets ≥ 100 000/µl (≥ 100 Gpt/l): 75 mg/m², platelets ≥ 50 000 - < 100 000/µl (≥ 50~          - <100 Gpt/l): 50 mg/m², platelets < 50 000/µl (<50 Gpt/l): stop temozolomide until~          platelet recovery ≥ 100 000/µl (≥100 Gpt/l)~        -  Study treatment in the individual patient is scheduled for 1 year unless tumor~          progression or excessive toxicity occurs. However, study treatment may be extended~          beyond 1 year upon individual decision.~   "
156495|NCT01517763|"~     A total of 216 patients will be randomized into a partially single blind, randomized,~     parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can~     improve therapy adherence when compared to standard care with a fixed pressure Continuous~     Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP~     device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously~     diagnosed with moderate-severe obstructive sleep apnea (OSA).~   "
156496|NCT01517750|"~     Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper~     airway obstruction, acceptance of and adherence with therapy has been sub-optimal. One of the~     only technological advancements shown to increase adherence is heated humidification, now~     considered part of conventional CPAP therapy in some countries. ThermoSmart™ is a unique~     technology developed by Fisher & Paykel Healthcare which utilises a heated breathing tube to~     deliver optimal humidity in all environments. ThermoSmart has been shown to be superior to~     conventional humidification in reducing side effects, condensation and titrated pressure as~     well as increasing total sleep time. However, improved humidity delivery has not lead to~     significantly increased adherence in unselected obstructive sleep apnea (OSA) patients.~      A total of 80 patients diagnosed with OSA but naive to CPAP use will be randomized into a~     single blind, randomized, parallel-arm trial to determine whether the the use of heated~     humidification will impact therapy adherence.~   "
156562|NCT01516892|"~     This open-label study will assess the long-term efficacy, safety, and tolerability of~     onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic~     migraine.~   "
156497|NCT01517737|"~     Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with~     anticipated long-term survival since the bearing surfaces wear less than the traditional~     metal-on-plastic (MoP) replacements. However, the production of metal ions as a result of the~     wear is a concern because of the possible toxicity to cells. In Norwich England a number of~     different metal-on-metal implants have been trialed of which one, the Ultima TPS, has had~     very poor results. A total of 545 patients have had 652 MoM THRs with the Ultima TPS of whom~     more than 20% have now been revised. There is an ongoing MHRA program to screen for problems~     using MRI scans with a technique developed in Norwich. Investigations so far show massive~     corrosion in the implants with a catastrophic immune response causing death of cells. This~     may include death of bone leading to fracture. In a third of patients revised there has been~     pain but normal plain X-rays. In some patients without pain who have been screened there are~     abnormal changes on an MRI scan. We wish to investigate the immune cells in patients to find~     out why this has happened. The study will include patients coming for a new hip to act as a~     comparator, as well as those with a MoM THR and patients being revised with MoM THRs, and MoP~     THRs. We shall also investigate patients with other MoM THRs opportunistically.~   "
156498|NCT01517724|"~     The aim of this trial is to determine whether bortezomib improves response and delays~     progression for multiple myeloma patients after high dose therapy and autologous stem cell~     transplant. It will also assess the effect of bortezomib treatment on patient bone health.~   "
156499|NCT01517711|"~     This is a six-week pilot study testing the efficacy of tramadol extended-release (ER) for~     posttraumatic stress disorder (PTSD). Men and women aged 21-55 years with combat-related PTSD~     (n = more than 20) or PTSD resulting from a civilian trauma (n = fewer than 20) will be~     recruited. Blinded tramadol ER will begin with a 100 mg daily dose for the first week, with~     an option to increase to 200 mg/day for the 2nd week. Dose adjustments, using a range of~     100-300 mg tramadol ER per day (or 1 to 3 placebo tabs), are permitted thereafter. The~     primary hypothesis is that tramadol ER 100 to 300 mg every morning for 6 weeks will reduce~     the symptoms of PTSD relative to placebo. The primary outcome measures will be PTSD symptoms~     as rated by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions~     scale at baseline and weeks one, two, four, and six. Assignment to blinded medication arms~     will be stratified to ensure equivalence of the two arms (men and women, military and~     civilian trauma).~   "
156500|NCT01517698|"~     This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will~     investigate the efficacy and safety of RO4917523 in adolescent and adult patients with~     fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of~     RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12~     weeks.~   "
156501|NCT01517685|"~     This research is being done to study the effect of taking flax seed oil and fish oil on blood~     lipids in vegetarians following the Hallelujah Diet. Omega 3 fats are important to our health~     and we want to see how effective both flax seed oil and fish oil are in raising your Omega 3~     Score (higher is better). The Omega 3 Score is one of many indicators that may show your~     personal risk of dying suddenly from a heart attack.~   "
156502|NCT01517672|"~     Identifying neural mechanisms of posttraumatic stress disorder (PTSD) treatment could help~     elucidate reasons for variable treatment response and identify novel treatment targets.~     Exposure-based therapies have been associated with decreased amygdala and increased cingulate~     cortex response during emotional processing. The current study examined whether cognitive~     therapy for PTSD in women reduces activation in insula and amygdala and enhances activation~     in prefrontal regions during emotional anticipation and pre-treatment prefrontal activation~     predicts treatment response.~   "
156503|NCT01517659|"~     Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the~     ZELTIQ CoolSculpting System.~   "
156504|NCT01517646|"~     This study is being performed to reduce unwanted fat, in various body areas, using a new~     applicator and control unit for Zeltiq.~   "
156505|NCT01517633|"~     The purpose of this study is to compare the reliability and validity of a new device with~     standard methods for diagnosing between amniotic fluid leakage due to premature rupture of~     the membranes (PROM) and urine.~   "
156506|NCT01517620|"~     This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and~     safety of total glucosides paeony capsules in maintaining clinical remission in patients with~     ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients~     will be divided into two groups randomly, one group receive non-steroid anti-inflammatory~     drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus~     NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which~     disease activity reaches relapse criteria. The investigator's hypothesis the proportion of~     relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID~     mono-therapy group.~   "
156507|NCT01517607|"~     This non-interventional study examines whether the patient's level of information and the~     consideration of the patient's preference have a positive effect on the compliance and thus~     also on the therapeutic success.~   "
156508|NCT01517594|"~     Confirmation of safety profile~   "
156509|NCT01517581|"~     White and brown adipocytes differ in their expression of hormones, cytokines, and~     inflammatory factors, and they modulate different biological functions. While white adipose~     tissue (WAT) serves as the primary site of energy storage, brown adipose tissue (BAT) instead~     metabolizes fat to produce heat and regulate body temperature. BAT is likely present in all~     humans, but the low prevalence of BAT depiction in adults and elderly subjects has hindered~     longitudinal assessments of the relation between BAT activity and WAT. Under typical imaging~     conditions, BAT is detected more frequently in children and teenagers than in adults with~     malignancy. Since most children with cancer have significantly shorter treatment courses and~     greater survival rates compared to adult patients, the investigators have the ability to~     examine the relation of repeated measures of body composition and BAT by selecting pediatric~     patients. In this study, the investigators will longitudinally examine whether BAT activity~     is related to changes in weight and the amounts of SAT, VAT, and abdominal muscle in children~     successfully treated for pediatric cancer.~   "
156510|NCT01517568|"~     This trial is conducted in Europe. The aim of this trial is characterise the metabolic~     profile of liraglutide in plasma, urine, and faeces after a single injection of~     [3H]-liraglutide.~   "
156512|NCT01517542|"~     Stroke is the leading cause of disability worldwide and the leading cause of death in Brazil.~     It is estimated that about 18 million people will have a stroke in 2015 and approximately one~     third of these resulting in death. The factors most important modifiable risk for stroke~     include high blood pressure (hypertension), diabetes, smoking, dyslipidemia, sedentary~     lifestyle and obesity. Acting on these risk factors can be reduced by 88% the risk of another~     stroke. Healthy eating is among the changes in lifestyle that are recommended for prevention~     and treatment of one of the main risk factors for stroke. Studies show that the adoption of~     the DASH diet can significantly reduce blood pressure and the result is even more significant~     in hypertensive patients, making this diet a new alternative in the prevention and treatment~     of hypertension and consequently stroke. Compliance therapy is a determining factor for~     success in the treatment of chronic diseases. Adherence to long-term treatment in developed~     countries is around 50% and in developing countries the rates are even lower. The aim of this~     study is to evaluate the effectiveness of nutritional counseling in an adapted DASH style~     diet on body weight, glycemic control, blood pressure values and improved lipid profile~     compared to the usual diet without nutritional counseling in patients with stroke within the~     last 3 months. The hypothesis is that nutritional counseling with an adapted DASH style diet~     reduces cardiovascular risk factors compared with the usual diet without nutritional~     counseling in patients with stroke within 3 months. The stroke patients will be selected in~     the hospitalization or in the outpatient clinic of Hospital de Clínicas de Porto Alegre in a~     period up to 3 months after ischemic stroke. The patients will be randomized to one of the 2~     groups. In the first visit they will be submitted to a social class and international~     physical activity questionnaire and they will be submitted to a food frequency questionnaire,~     measures of weight, height, waist circumference, hip and neck, blood pressure and cholesterol~     and glucose measurements at the baseline, 30 days and 3, 6, 9 and 12 months. The main~     endpoints will be the change in the body weight, blood glucose, blood pressure values and~     lipid profile.~   "
156513|NCT01517529|"~     The major goal of this project is to identify the role of the immune responses in the~     emergence of protease inhibitor mutants during therapy.~   "
156514|NCT01517516|"~     The structural/RSN study involves Structural and Resting State Neuroimaging. The purpose of~     Structural Neuroimaging is to use MRI technology to identify cortical and white matter~     morphometric differences between patients with chronic pain conditions and healthy control~     subjects.~      The purpose of the Resting State Neuroimaging study is to use functional MRI to identify~     possible disease related differences in various resting state networks in the brain.~      In addition we are looking at the effect gut microbiota on brain function in healthy and IBS~     participants.~      The overall goal is to identify structural and functional brain differences in persons with~     chronic pain conditions such as Irritable Bowel Syndrome (IBS, Cyclical Vomiting~     Syndrome(CVS) and vestibulodynia/vulvodynia. We are also looking at Inflammatory Bowel~     Disease(ulcerative colitis and Crohn's disease. We will be comparing differences between~     these conditions and matched healthy control subjects.~   "
156515|NCT01517503|"~     The study will investigate the effectiveness of Cognitive Therapy and Acceptance and~     Commitment Therapy in a randomized controlled trial among patients with Major Depressive~     Disorder in routine clinical practice. Furthermore, the study will investigate whether each~     specific treatment approach is mediated by its proposed theoretical mechanism.~   "
156516|NCT01517490|"~     Retinal function is highly dependent on the glucose supply. Thus, functional adaptations~     occur in response to both acute and long-term changes in glycaemia.~      The purpose of this study is to examine functional and metabolic aspects of retinal~     adaptation to long-lasting changes in glycaemic control in patients with diabetes. The~     adaptational phenomena will be characterized by electroretinography, dark adaptation,~     measures of retinal perfusion and oximetry as well as diabetic retinopathy grading and (OCT).~   "
156517|NCT01517477|"~     The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure~     (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on~     two anti-glaucoma medications.~   "
156518|NCT01517464|"~     This is a Phase I study designed to evaluate the safety and maximum tolerated dose (MTD) of~     SGT-94, a novel, tumor-targeted, systemic gene therapy agent for cancer. In addition, we will~     look for evidence of RB94 expression within tumor tissue after systemic administration of~     SGT-94.~   "
156519|NCT01517451|"~     A study to see how effective and tolerable radiation therapy along with androgen deprivation~     therapy is in treating prostate cancer.~   "
156520|NCT01517438|"~     ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or~     adenoidectomy in children~   "
156521|NCT01517425|"~     This research is being done to understand how changes in DNA may put people at risk for~     developing coronary artery disease. Stem cells will be made using cells from blood and/or~     skin biopsy samples. We are trying to understand which specific changes in DNA negatively~     impact a person's health.~   "
156522|NCT01517412|"~     Primary Objective:~      - To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c)~     from baseline to endpoint (Week 24)~      Secondary Objective:~        -  To assess the effect of the 2 lixisenatide regimens on:~             -  The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at~               Week 24~             -  Fasting Plasma Glucose (FPG)~             -  7-point Self-Monitored Plasma Glucose (SMPG) profiles~             -  Body weight~        -  To assess the safety and tolerability of the 2 lixisenatide regimens~   "
156523|NCT01517399|"~     The purpose of this study is to determine the effects of tivantinib on the pharmacokinetics~     of omeprazole, s-warfarin, caffein, midazolam, or digoxin in patients with cancer.~   "
156524|NCT01517386|"~     For effective anesthesia and interventional pain treatments, correct needle placement is~     crucial. Currently used methods to guide needle placement and confirm the actual treatment~     location before injection of the medication include: image-guidance, loss-of-resistance, and~     electrical stimulation. However, accuracy of needle placement could be improved if~     information would be available that would complement the current methods. We have developed~     the so-called photonic needle technology based on optical spectroscopy that has the~     potential to provide such complementary information.~      This study is an observational study in a limited number of patients. A common~     ultrasound-guided regional anesthesia procedure has been selected, during which data will be~     acquired with the photonic needles at a number of points along the needle trajectory that~     allow for confirmation by imaging.~      Rationale for this study is to investigate the potential of the technology to discriminate~     tissues that are relevant to distinguish during the procedure.~   "
156525|NCT01517373|"~     This is a study to understand efficacy and safety of investigational agent (PF-04937319)~     compared to approved agent (glimepiride) in patients with diabetes on metformin~   "
156526|NCT01517360|"~     This study will evaluate whether oxytocin will facilitate the learning of social cognitive~     skills in schizophrenia patients who receive 12 sessions of Social Cognitive Skills Training~     (SCST). The primary hypothesis is that schizophrenia subjects who are treated with oxytocin~     will demonstrate greater improvements in a summary measure of social cognition than subjects~     treated with placebo over the course of SCST.~   "
156527|NCT01517347|"~     Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only,~     option for the treatment of leukemia. However, relapse rate was still the key question to~     influence the overall survival after transplantation, even in standard risk leukemia.There~     were good evidences that natural killer cells and T regulatory cells, which were expanded and~     stimulated by the application of IL-2, could mediate protection against GvHD while~     maintaining graft anti-tumor activity as a positive side effect. Meanwhile, it was found in~     our previous pilot study that low-dose IL-2 subcutaneous administration from 100 days for a~     prolonged period could be a safe and effective strategy to prevent relapse in acute~     lymphoblastic malignancy patients with high risk of recurrence after unmanipulated allo-HSCT.~      The study hypothesis:~      Prevention of relapse using low dose IL-2 following hematopoietic stem cell transplantation~     in patients with standard risk acute leukemia can~        -  reduce relapse rate~        -  improve survival~   "
156528|NCT01517334|"~     The objective of the study is to evaluate the safety, effectiveness and anti-microbial~     effects of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with~     peri-implantitis, when used in combination with mechanical debridement.~      The hypothesis of the study is that Arestin in combination with mechanical debridement is~     more effective in the treatment of peri-implantitis when compared to mechanical debridement~     alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as~     measured at qualifying implant sites.~   "
156529|NCT01517321|"~     This Phase III clinical trial will examine the safety, tolerability, and efficacy of the~     addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have~     inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue~     monotherapy.~   "
156530|NCT01517308|"~     Aim of the present study is to evaluate in a cohort of patients with genotype 2/3 chronic~     hepatitis C, relapsers to a previous PEG-IFN + ribavirin therapy (alpha-2a or alpha-2b) the~     efficacy of PEG-IFNα-2a + ribavirin administered for 24 or 48 weeks. It will be evaluated~     whether 48 weeks of therapy may achieve better results compared to the standard duration (24~     weeks).~   "
156531|NCT01517295|"~     Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite~     hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3~     months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.~   "
156532|NCT01517282|"~     Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous~     system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits an~     unpredictable and variable clinical course.~      Multiple sclerosis plaques contain numerous types of cells and infiltrating macrophages have~     been identified to contribute significantly to demyelination in both clinical MS and animal~     models of MS. Granulocyte-macrophage colony-stimulating factor (GM CSF) stimulates~     proliferation and activation of macrophages, monocytes, neutrophils, eosinophils, dendritic~     cells and microglia with subsequent induction of proinflammatory biomolecules.~      Therefore blocking GM CSF activity might be a therapeutic approach for the treatment of MS.~   "
156533|NCT01517269|"~     Hypothesis: Parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have~     significantly higher diabetes knowledge (cognitive visual schemata), better technical and~     problem-solving competence and confidence, and lower fear and stress/anxiety levels; and~     provide better diabetes management at 14 weeks compared to those parents receiving standard~     diabetes education.~   "
156534|NCT01517256|"~     The investigators will evaluate the effectiveness of Living Everyday Above-and-beyond Pain~     (LEAP) program in the primary care setting. LEAP is a multidisciplinary chronic pain group~     therapy developed for the two clinic sites of McMaster Family Health Team: McMaster Family~     Practice and Stonechurch Family Health Centre. LEAP aims to improve patients'quality of life,~     interaction with the health care system and their health care utilization. This is a pilot~     study to evaluate mainly feasibility. The investigators will make use of both experimental~     and qualitative methods gather evidence of the programs success, strengths and weaknesses.~   "
156535|NCT01517243|"~     In the past 5 years, treatment for metastatic Renal Cell Carcinoma (mRCC) has focused on~     agents directed at blocking tumor and vascular growth pathways. Sunitinib blocks the vascular~     endothelial growth factor receptor (VEGFr) and temsirolimus is an inhibitor of mammalian~     target of rapamycin (mTOR). Both sunitinib and temsirolimus are FDA approved agents for mRCC.~     When agents like these are given together, the toxicity increases but they can be given~     safely, at full doses, sequentially. We hypothesize that alternating these agents will double~     the progression free survival (PFS) of the agents when given sequentially.~   "
156536|NCT01517230|"~     A cluster-randomised trial will be undertaken in Burkina Faso to investigate whether a~     comprehensive mass media campaign using local radio stations can change behaviours on a scale~     large enough to result in measurable and sustainable reductions in under-five child~     mortality.~      It is hypothesised that as a result of the scale and multi-pronged nature of the campaign,~     reductions of between 10% and 20% in child mortality will be achieved.~   "
156537|NCT01517217|"~     There is a considerable lack of knowledge in everyday surgical practice concerning treatment~     with a corset after laparotomy, in surgery for incisional hernia or as conservative~     treatment.~      The aims are to elucidate effects of corset treatment on patient experience and pain,~     physiology and abdominal wall strength.~      Effects of corset treatment after laparotomy will be studied in a randomised trial with the~     hypothesis that postoperative corset-use improves respiratory physiology and reduce pain. The~     primary end-point is PeakCoughFlow change, secondary end-points are vital capacity, residual~     volumes and patient perception as measured by the ventral hernia pain questionnaire (VHPQ)~     developed by our group. This study is powered for 50 patients.~      Conclusions from the study are of such a nature that they can be immediately transferred to~     clinical practice.~   "
156538|NCT01517204|"~     The purpose of this study is to investigate the effects of Trachway(R) compared with direct~     laryngoscope in tracheal intubation of double-lumen endobronchial tube.~   "
156539|NCT01517191|"~     This surveillance study will include all consenting adults hospitalized with influenza~     (cases) at the SOS network of hospitals as well as influenza negative patients(controls), to~     assess vaccine effectiveness in each group. Both groups will be followed throughout their~     hospitalization and for 30 days post discharge to monitor severity of illness and outcomes~     following their illness.~   "
156540|NCT01517178|"~     The primary object of this study is to provide clinical documentation for the New base plate~     significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care~     base plates.~      The secondary objectives are to provide clinical documentation on several performance and~     safety parameters on the New base plate compared to Standard Care base plates.~      The primary hypothesis is that the New base plate significantly reduces degree of leakage~     under the base plate compared to Standard Care base plates.~      Each test period will last for two weeks. In addition to this there will be one week run-in~     period on New base plate. The data will be collected by investigator in the Case Report Form~     at the inclusion visit, cross-over visit and termination visit. Data will also be collected~     by the subject in a questionnaire during the two test periods.~      The subjects will change their base plates on per need basis and continue with their normal~     changing pattern in the entire study period.~      100 subjects with ileostomy will be included in the study. The subjects will be recruited~     from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.~   "
156541|NCT01517165|"~     Background:~        -  Opioid-withdrawal symptoms include runny nose, body aches, chills, sweating, and~          diarrhea. Many people have these symptoms when trying to stop using opioid drugs.~          Long-acting opioids like methadone and buprenorphine are used to help people stop using~          other opioids, but these drugs can cause the same withdrawal symptoms. There are no~          non-opioid drugs that are approved specifically to treat those symptoms.~        -  Pioglitazone is a drug used to treat type 2 diabetes. In a research study, the drug~          allowed heroin users to decrease their methadone dose faster without much discomfort,~          and stay abstinent from heroin. Researchers want to learn more about how pioglitazone~          helps treat opioid withdrawal symptoms.~      Objectives:~      - To test whether pioglitazone can reduce opioid withdrawal symptoms.~      Eligibility:~      - Individuals between 18 and 65 years of age who will be using buprenorphine to treat opioid~     dependency.~      Design:~        -  This study will last up to 17 weeks. Participants must come to the study clinic every~          day for at least 13 weeks.~        -  Participants will be screened with a physical exam and medical history. They will also~          answer questions about drug use habits, and provide blood and urine samples.~        -  Participants will take buprenorphine daily for 7 weeks. For the first 3 weeks, the dose~          will be increased to a level that should help stop the use of opioids. For the next 4~          weeks, the dose will be decreased. Blood, urine, and breath samples will be collected at~          different study visits. Participants will also fill out questionnaires about mood, drug~          craving, and withdrawal symptoms.~        -  After 1 week on buprenorphine, participants will start the study pill (pioglitazone or a~          placebo) every day. They will take the study pill for 13 weeks.~        -  During the treatment period, participants will have drug counseling once a week for 30~          minutes.~        -  Some participants have other tests as part of this study. These tests include functional~          magnetic resonance imaging scans to look for changes in brain activity and giving~          samples of cerebrospinal fluid to study brain chemistry.~        -  Participants will have a final followup phone call 3 weeks after the last clinic visit.~   "
156542|NCT01517152|"~     Background:~        -  The Common Terminology Criteria for Adverse Events (CTCAE) is a list of toxicities and~          side effects that may occur when people are having cancer treatment. Doctors and nurses~          use this list to describe the side effects patients experience from cancer treatment. We~          have developed a questionnaire to ask people having cancer treatment directly about~          common symptoms and side effects and to supply this information to their doctors and~          nurses. This questionnaire is known as PRO-CTCAE and is completed by a patient.~        -  PRO-CTCAE was originally developed in English. Researchers want to develop a Spanish~          version of the patient questionnaire. To test whether the questions are well understood~          and whether it is easy to complete the questionnaire, the researchers will interview~          individuals whose primary language is Spanish and who are being treated for different~          types of cancer.~      Objectives:~      - To test a Spanish version of the PRO-CTCAE questionnaire.~      Eligibility:~      - Latinos at least 18 years of age who are having or have recently finished cancer treatments~     and whose main language is Spanish~      Design:~        -  Participants will complete a questionnaire in Spanish with selected questions from the~          translated PRO-CTCAE. They will discuss their answers and any difficulties they might~          have had in understanding or answer the questions with an interviewer, who will take~          notes and record comments and suggestions.~        -  Literacy is not required for this study. Participants may opt to have the questions read~          aloud to them by an interviewer.~   "
156543|NCT01517139|"~     Background:~      - Researchers want to collect information on diet, physical activity, and sun exposure in~     children and young adults. The data can provide information on the effect these factors might~     have on the development of cancer and other diseases. Information collected only from adults~     does not accurately measure these factors. To collect more accurate information, both mothers~     and children will provide information. Study participants will be from Hebei province in~     northeastern China and Jiangsu province in eastern China.~      Objectives:~      - To collect and study diet, activity, and sun exposure data from Chinese adolescents and~     their mothers.~      Eligibility:~        -  Adolescents between 15 and 17 years of age from Hebei and Jiangsu provinces in China.~        -  Mothers of the study adolescents.~      Design:~        -  Participants will answer questions about their diet, physical activity, and time in the~          sun.~        -  Participants will wear a pedometer to measure activity for 7 days. They will also wear a~          badge to measure sun exposure for 3 days.~        -  Participants will record their activities and food and drinks consumed for 3 days. Urine~          samples will be collected for a full day.~        -  Participants will have a grip strength test. On the last day of the study, they will~          provide blood, saliva, and toenail samples.~        -  A smaller separate group of adolescents will provide saliva samples only and complete a~          food questionnaire.~   "
156544|NCT01517126|"~     Background:~      - Currently, there is no standard method to study suicide risk in youth with developmental~     delays or intellectual disabilities (DD/ID). Youth with DD/ID are often excluded from studies~     that are used to develop these methods. As a result, most current suicide risk assessments~     have not been tested for use with people with DD/ID. Researchers want to develop an effective~     suicide risk screening tool for children and adolescents with DD/ID.~      Objectives:~      - To develop a suicide risk screening tool for young adults with DD/ID.~      Eligibility:~        -  Young adults between 12 and 21 years of age who have DD/ID and are in mental health~          counseling.~        -  Participants will be in counseling at Surrey Place Centre, a community health center in~          Toronto, Canada.~      Design:~        -  Participants will fill out questionnaires during a 1-hour meeting with a therapist. The~          questions will ask about mood and current feelings, including whether the participant~          has been thinking about or planning to hurt or kill him or herself now or in the past.~          Other questions will ask about participants' understanding of death in general.~        -  Parents of participants may also fill out a questionnaire. It will ask about how the~          participant has been feeling. It will also ask whether the parent has noticed any signs~          that suggest suicidal thoughts or actions, now and in the past.~        -  Treatment will not be provided as part of this protocol. However, participants can~          receive counseling through the regular Surrey Place Centre services.~   "
156545|NCT01517113|"~     Background:~      - Advancing age is associated with greater risk of heart disease. High blood pressure and~     hardening of the arteries also have more complications with age. Studies suggest that~     age-related inflammation may affect fatty tissue in the body. If this fat develops in the~     muscles or around the heart, it may increase risks of heart disease. Researchers will study~     body composition in older adults to see if age-related changes in body fat are related to~     higher risks of heart disease.~      Objectives:~      - To study the relationship between fat deposits and aging, and greater risks of heart~     disease.~      Eligibility:~        -  Participants in the Baltimore Longitudinal Study of Aging between 50 and 80 years of~          age.~        -  Individuals between 50 and 80 years of age who have been diagnosed with coronary artery~          disease.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will provide blood and urine samples. They will also have their height and~          weight measured. Waist circumference will also be taken.~        -  Participants will have a DEXA scan to study their muscles.~        -  Participants will have magnetic resonance imaging scans. These scans will study heart~          function and muscle and blood vessel health.~        -  Participants with coronary artery disease will have catheterization. Blood samples will~          be collected during the procedure....~   "
156546|NCT01517100|"~     Background:~      - The endocannabinoid system is involved in different body functions and processes. It helps~     regulate appetite and mood, and sends signals to the nervous system. It may also be involved~     in how the body produces insulin during digestion. Researchers want to test two drugs that~     work on the endocannabinoid system: nabilone and CP-945,598. These drugs may be able to~     affect insulin levels in the blood. This information may suggest possible new treatments for~     people with diabetes.~      Objectives:~      - To study how the endocannabinoid system is involved in insulin production and action.~      Eligibility:~      - Healthy men between 21 and 55 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and urine samples. They will also have imaging studies to test their brain~          responses, especially to food-related cues. Some participants will also have a study~          visit to test their insulin resistance levels.~        -  Participants will have four separate study visits 6 weeks apart. They will keep a food~          diary before each visit. At each visit, they will have one of the following combinations~          of drugs:~        -  Double placebo~        -  Placebo and nabilone~        -  Placebo and low dose of CP-945,598~        -  Placebo and high dose of CP-945,598.~        -  Participants will have follow-up visits 1 week after each study visit. Blood samples~          will be taken.~   "
156547|NCT01517087|"~     Background:~      - People with motor neuron disorders have changes in the parts of the brain that control~     movement. Some tests that are currently used to study these changes are magnetic resonance~     imaging (MRI) and transcranial magnetic stimulation (TMS). We don t know if MRI scans and TMS~     give the same results if done at different times in the same person. Researchers want to see~     if these tests produce different results if given to healthy adults on two separate~     occasions.~      Objectives:~      - To test the reliability of different tests of the brain used to study motor neuron~     disorders.~      Eligibility:~        -  <TAB>Healthy individuals at least 35 years of age who have no history of neurological~          disorders and take no medications.~        -  <TAB>Pregnant women may not participate.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will have two testing visits 1 to 6 months apart.~        -  The first visit will have three parts. The first part is a neurological exam to test~          strength, sensation, reflexes, and coordination of movement. The second part will be TMS~          tests. The third part will involve an MRI scan to study the parts of the brain that~          control movement.~        -  At the second visit, participants will have MRI scanning only.~   "
156548|NCT01517074|"~     Background:~      Autoimmune scleritis is an inflammatory disease that affects the white outer part of the eye.~     It is associated with immune system disorders like rheumatoid arthritis. It can cause~     blindness in severe cases. Most treatments for scleritis involve steroid or~     immune-suppressing drugs, but these can cause side effects in the whole body.~      Sirolimus is a drug used to help prevent transplant rejection. It helps prevent the immune~     system from attacking the body. Researchers want to try giving sirolimus injections into the~     eye to treat severe scleritis.~      Objectives:~      To see if sirolimus is a safe and effective treatment for autoimmune scleritis.~      Eligibility:~      Individuals at least 18 years of age with autoimmune scleritis in at least one eye that has~     not responded to standard treatments.~      Design:~        -  Participants will be screened with a medical history, physical exam, and eye exam. Blood~          and urine samples will also be collected.~        -  One eye will be selected as the study eye to receive injections.~        -  Participants will have six study visits over 4 months (initial visit and weeks 2, 4, 8,~          12, and 16). The injection will be given at the first visit. If the study eye responds~          to the treatment, participants may have injections in the other eye at the second visit.~        -  If there is still inflammation after the first injection, or if the scleritis improves~          but then returns, participants may have a second injection at Week 4.~        -  Injections will be monitored with blood tests and eye exams.~        -  Participants may have study visits and injections for up to 1 year if the injections~          seem to be working.~   "
156549|NCT01517061|"~     Background:~      - Many people who lose a limb feel pain in the missing limb. This feeling is called phantom~     limb pain. Researchers do not fully understand what causes this pain. Differences in people's~     genes may play a role. Comparing the genes of people with and without phantom limb pain may~     help researchers better understand this feeling, who is likely to develop it, and how to~     treat it.~      Objectives:~      - To study whether genetic differences affect phantom limb pain.~      Eligibility:~      - Individuals at least 18 years of age who have lost an arm or leg at least 3 months ago.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will answer questions about how they lost the limb, and whether they feel~          phantom limb pain. They will also have a test to measure their sensitivity to heat and~          cold.~        -  Participants will provide a blood sample for genetic testing.~   "
156563|NCT01516879|"~     To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC)~     evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering~     therapy.~   "
156550|NCT01517048|"~     Background:~      - Prader-Willi syndrome (PWS) and MC4R genetic mutations are two conditions that can cause~     problems with appetite regulation. People with PWS often have behavior and thinking problems.~     People with MC4R mutations may have problems with attention. These problems may be related to~     Brain-Derived Neurotrophic Factor (BDNF), a protein that is important for brain development.~     Researchers want to study people with PWS and MC4R mutations to see how BDNF is involved in~     these conditions. Specifically, body weight and brain function will be studied, and compared~     with healthy volunteers.~      Objectives:~      - To study how BDNF affects body weight and brain function in people with PWS and MC4R~     mutations.~      Eligibility:~        -  Individuals of any age who have Prader-Willi syndrome or MC4R genetic mutations.~        -  Healthy volunteers of any age to act as control participants.~      Design:~        -  Participants will be screened with a medical history and physical exam. Height, weight,~          and waist/hip circumferences will be measured. Blood samples will be taken for genetic~          and other tests.~        -  Participants will fill out questionnaires about eating habits, pain perception, and~          sleep behavior.~        -  Participants will keep a 3-day food diary to record all food and drinks eaten.~        -  Tests and questionnaires will be given to study thinking, speech, movement, behavior,~          and mood. Some tests will be done on a computer; other tests will be on paper. Tests may~          also involve performing tasks with blocks and other objects.~        -  Participants may have other tests as directed. These will include hot and cold~          sensitivity tests, imaging studies like x-rays, and measurements of body fat and water~          content.~        -  Treatment will not be provided as part of this study.~   "
156551|NCT01517035|"~     Background:~      - People who have some kinds of cancer can benefit from donated bone marrow stem cells. These~     stem cells help produce healthy bone marrow and slow or stop the spread of abnormal cells.~     However, stem cells transplants do not always work. Also, they may have serious side effects~     that can cause illness or death. The Bone Marrow Stem Cell Transplant Program is studying~     methods to make stem cell transplant procedures safer and more effective.~      Objectives:~      - To test a new procedure that may improve the success and decrease the side effects of stem~     cell transplants.~      Eligibility:~        -  Individuals 10 to 75 years of age who have a life-threatening illness that may require a~          stem cell transplant.~        -  Healthy siblings who are able to provide stem cells for transplant.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and urine~          tests.~        -  Donor procedures:~        -  Stem cell donors will start by having apheresis to donate white blood cells.~        -  Donors will receive filgrastim shots for 5 days to help move stem cells into the blood~          for collection.~        -  Donors will have another round of apheresis to donate the stem cells for transplant.~        -  Recipient procedures:~        -  Before the transplant, recipients will have radiation twice a day for 3 days and~          chemotherapy for 7 days.~        -  After the radiation and chemotherapy, recipients will receive the stem cells provided by~          the donor.~        -  After the transplant, recipients will receive the white blood cells provided by the~          donor.~        -  Recipients will be monitored closely for 4 months to study the success of the~          transplant. They will have more followup visits at least yearly thereafter.~        -  Recipients will have a research apheresis prior to transplant and at 3 months.~   "
156552|NCT01517022|"~     The aim of the study is to determine the impact of a package of smoking-cessation~     interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes.~      Given the lack of objective clinical data/evidence about the impact of smoking-cessation on~     TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to~     be beneficial particularly in patients with TB, this study proposes to determine the impact~     of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation~     (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis~     therapy. This is to be compared with the structured counselling for smoking-cessation that is~     recommended to be routinely provided by health care workers to all patients who are smokers.~     If the results prove that such a smoking-cessation PI indeed improves outcomes in TB~     patients, such information would strongly motivate for the institution of more intensive~     smoking-cessation interventions in TB clinics than is currently being employed for TB~     patients~   "
156553|NCT01517009|"~     The purpose of this study is to determine the feasibility of chemotherapy, consisting of~     docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore,~     an extended type of removal of lymph nodes will be implemented.~   "
156554|NCT01516996|"~     The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to~     neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally~     advanced squamous cell carcinoma of the oropharynx and hypopharynx.~   "
156555|NCT01516983|"~     The purpose of this study is to evaluate the safety and tolerability of Icotinib at different~     dose levels in combination with whole brain radiotherapy for NSCLC patients with brain~     metastases and EGFR mutation.~   "
156556|NCT01516970|"~     The primary purpose of this study is to assess the rate of early discontinuation from~     randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason~     other than confirmation of the negative HIV infection status of the index person in patients~     receiving HIV PEP for at least 28 and a maximum of 30 days.~   "
156557|NCT01516957|"~     The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic~     arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid~     that does not have any drug in it) and neither the doctor nor the patient will know what~     treatment is being given.~   "
156558|NCT01516944|"~     Stage I：Neoadjuvant therapy~        -  Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to~          surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and~          Oteracil Potassium Capsules plus oxaliplatin~      Stage II: Perioperative therapy~        -  Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is~          superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin~          alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and~          Oteracil Potassium Capsules plus oxaliplatin~        -  A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and~          Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable~          locally advanced or metastatic gastric cancer. The investigators assessed whether the~          addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves~          R0 resection rate and survival among patients with curable locally advanced gastric~          cancer.~   "
156559|NCT01516931|"~     The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic~     stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome~     Measures:Time between subject randomization to treatment and the first occurrence of a~     relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as~     measured by Hamilton Depression Rating Scale (HDRS); Illness severity change as measured by~     Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject~     functioning using the Personal and Social Performance Scale.~   "
156564|NCT01516866|"~     The purpose of this research study is to evaluate a newer imaging technique, called~     18F-Sodium Fluoride (NaF) positron emission tomography (PET). NaF is a tracer (dye) that is~     very sensitive for changes in bone. By using this tracer with positron emission~     tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes~     in bone lesions could be greatly improved.~   "
156565|NCT01516853|"~     The purpose of this study is to validate magnetic resonance imaging as a biomarker of hepatic~     iron concentration (HIC). Excessive accumulation of iron in the body is highly toxic,~     specifically in the liver. Accurate, non-invasive assessment of HIC is needed for diagnosis,~     quantitative staging and treatment monitoring or hepatic iron overload.~   "
156566|NCT01516840|"~     The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and~     pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein~     thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary~     embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.~   "
156567|NCT01516827|"~     This multi-site randomized controlled trial compares the effectiveness of Trauma-Focused~     Cognitive-Behavioral Therapy (TF-CBT) as developed by Cohen, Mannarino & Deblinger (2006)~     with a wait-list condition in a population of children aged 7-16 years who were exposed to~     traumatic events beyond the age of three years, at least three months ago, and developed~     Posttraumatic Stress Disorder (PTSD). Primary aims are to provide evidence that TF-CBT~     exceeds spontaneous remission of posttraumatic stress symptoms and to assess maintenance of~     treatment gains at 6 and 12 months post-treatment. Secondary aims are to evaluate the~     effectiveness of TF-CBT in reducing other psychopathology and cognitive distortions of~     patients and caregivers and to explore moderators and mediators of treatment response. The~     trial will contribute to implement an evidence-based treatment for traumatized children~     across a variety of healthcare settings in Germany. The novel aspect is to evaluate the~     effectiveness of TF-CBT with a broad range of traumatized real-world patients in the~     context of the German mental healthcare system.~   "
156568|NCT01516814|"~     The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and~     pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the~     prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in~     Japanese patients with acute symptomatic PE with or without symptomatic DVT.~   "
156569|NCT01516801|"~     1. Does a one-page American College of Physicians educational flyer about the pros and cons~          of prostate cancer screening sent to men within two weeks of their scheduled annual~          health examinations in a general medicine clinic result in a different rate of prostate~          cancer screening than among men who were not sent the flyer?~        2. Do patients find the flyer useful and understandable?~      Context: The use of prostate specific antigen (PSA) screening for prostate cancer is~     controversial because of a lack of evidence that such screening saves lives when applied~     within a population and because such testing can lead to invasive downstream biopsies and~     aggressive treatment that is associated with a high risk of permanent side effects (e.g.~     impotence, incontinence). Almost all professional societies (American Cancer Society,~     American Urologic Association, American College of Physicians, United States Preventive~     Services Task Force) advocate that patients receive education and complete an informed~     decision-making discussion with their medical providers about the pros and cons of the PSA~     test, as well as their personal preferences, before proceeding with this test. Unfortunately,~     despite these recommendations, there is seldom sufficient time during clinic visits to~     achieve this goal.~   "
156570|NCT01516788|"~     Photosensitivity is well documented among lupus patients and is one of the diagnostic~     criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in~     lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly~     defined in lupus and its pathogenesis is not well understood. The purpose of this study is to~     characterize the early clinical and histopathological changes in lupus skin that occur as a~     response to ultraviolet light.~   "
156571|NCT01516775|"~     Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to~     minimize the risk of regurgitation, vomiting and pulmonary aspiration during general~     anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of~     this study and can be investigated in children undergoing elective procedures in intubation~     anaesthesia without inconvenience or additional invasive procedure and hence without~     additional risk~      Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia~     induction than in those that drink until 2 hours before anaesthesia induction~   "
156572|NCT01516762|"~     This study is a prospective, interventional, open-label, multi-center early access program~     for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis~     and to collect additional short and long term safety data on the product.~   "
156573|NCT01516749|"~     This is an open-label, proof-of-concept research study to assess the effectiveness of~     anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned~     intervention is to provide about 6 HS patients with anakinra 100mg daily injections to~     administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a~     further 8 weeks to monitor for relapse of HS.~   "
156574|NCT01516736|"~     The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the~     mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in~     breast cancer patients.~   "
156614|NCT01516216|"~     The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor~     in the cancer cells, it may stop cancer cells from growing abnormally and may cause cell~     death. Vitamin D has been used in other research studies and information from those other~     research studies suggests that Vitamin D may help in the treatment of colorectal cancer.~      In this research study, the investigators are comparing standard and higher dose Vitamin D~     treatment when given in combination with standard treatment for metastatic colorectal cancer.~     Standard treatment includes the chemotherapy combination of 5-FU, Leucovorin and Oxaliplatin~     (FOLFOX) with bevacizumab.~   "
156746|NCT01514487|"~     This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence~     between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase~     3 formulation at pH 7.7.~   "
196884|NCT00986232|"~     A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II~     and PUVV (Process Upgrade Varicella Vaccine) vaccines.~   "
156575|NCT01516723|"~     Percutaneous recanalization of total coronary occlusions (TCO) was historically hampered by~     high rates of restenosis and reocclusion. In the PRISON II and III trial we showed landmark~     reduction in restenosis with sirolimus-eluting stents (Cypher, Cordis Corporation) compared~     to conventional bare metal stents in TCO. In the PRISON III trial, we observed similar~     favourable results with second-generation zotarolimus-eluting stent (Resolute, Medtronic~     Inc.). Another drugs-eluting stent mounted with everolimus (Xience Prime, Abbott) also~     demonstrated favourable results in TCO. Recently, drug-eluting stents (DES) with~     bioresorbable polymer coatings were developed, to address safety concerns regarding the~     observation of very late stent thrombosis, due to hypersensitivity reactions, and chronic~     inflammation, on the durable polymer coating of DES. However, none of these DES with~     bioresorbable polymers were evaluated in patients with TCO. The PRISON IV trial is a~     prospective, randomized, single-blinded, multi-center trial, designed to evaluate the safety,~     efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable~     polymers (ORSIRO, Biotronik Inc.) compared to everolimus-eluting stents with durable polymers~     (Xience Prime, Abbott) in patients with successfully recanalized TCOs.~   "
156576|NCT01516710|"~     The purpose of the study is to compare outcomes of laparoscopic versus open liver resection~     for colorectal metastases in a prospective and randomized study. The study will include all~     non-anatomic liver resections in our institution.~      The primary end point is that the use of laparoscopic technique significantly can reduce the~     frequency of complications to liver resection. Secondary end points are 5-year survival,~     immediate surgical outcomes, quality of life and degree of impairment of the immune system.~   "
156577|NCT01516697|"~     The investigators hypothesize that continuously measuring stroke volume (SV) and cardiac~     output (CO) will 1) reveal hemodynamic instability in a timely manner and alert the physician~     promptly, 2) provide information for the physician to make the differential diagnosis as to~     whether the hemodynamic instability was due to vasodilatation or reduction of venous blood~     return, and 3) lead to appropriate and prompt treatment to improve patient outcome.~      -determine the SV and CO and their kinetic change using ICON® to establish a hemodynamic~     profile of the patient under spinal anesthesia for cesarean section. To determine if using~     instantaneous measurements of SV and CO to guide patient management improves hemodynamic~     stability.~   "
156578|NCT01516684|"~     This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients~     undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the~     skin and reducing movement when applied prior to lumbar punctures and may reduce the amount~     of sedation necessary~   "
156579|NCT01516671|"~     Subarachnoid hemorrhage (SAH) is associated with a high mortality and frequently leads to~     severe disability in survivors caused by cerebral vasospasm and infarction.~      This study aims to elucidate the role of neuroinflammation (endocannabinoids and cortisol~     levels in cerebrospinal fluid) in the pathophysiology of cerebral vasospasm and the value of~     the bilateral bispectral index (BIS) for the early diagnosis of cerebral vasospasm.~   "
156580|NCT01516658|"~     HYBRID study is prospective randomized open label controlled multi center trial, to compare~     Hydrocoil and bare platinum coil for recanalization after endovascular treatment of~     intracranial aneurysms.~   "
156581|NCT01516645|"~     This is a two-part, Phase 1 open label, single-center, dose escalation study of KHK2898 as~     monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy~     or for whom no standard therapy is available.~   "
156582|NCT01516632|"~     The investigators developed a text messaging-based smoking cessation program called SMS (Stop~     My Smoking) USA. It was tailored for the unique needs and smoking habits of young adults. The~     investigators hypothesized that those in the SMS USA intervention would be significantly more~     likely to be quit at 6-months compared to the attention-matched control group.~   "
156583|NCT01516619|"~     This is a monocentric, prospective phase II trial addressing safety and capability to prevent~     grade-4 Chemotherapy-induced Thrombocytopenia (CIT) of romiplostim in patients with NHL.~   "
156584|NCT01516606|"~     This is a prospective, phase II study on the activity and tolerability of high dose (2 g/day)~     oral clarithromycin for the treatment of relapsed or refractory extranodal marginal zone~     lymphoma.~   "
156585|NCT01516593|"~     This is a multicenter,open-label trial to evaluate activity and safety of the investigational~     intensive in HIV+ patients with Burkitt's lymphoma.~      Experimental treatment consists of an induction phase followed by a consolidation or~     intensified phase according to tumor response.~      Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was~     thought to limit the ability to administer intensive chemotherapeutic regimens due to~     infection rate. However, the advent of highly active antiretroviral therapy (HAART) and~     evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard~     chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive~     patients with the same intensive chemotherapy regimens used to treat immuno-competent~     patients. Data suggest that these current approaches, along with supportive care, may result~     in improved patient outcomes, similar to those in the immuno-competent patient population.~   "
156586|NCT01516580|"~     The aim of the trial is to test whether adding 6 injections of rituximab to standard~     Lymphome malin B LMB chemotherapy regimen improves the Event Free Survival (EFS) compared~     with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin~     Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH > Nx2, any stage IV or B-AL).~   "
156587|NCT01516567|"~     Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children~     and adolescent with primary mediastinal large B cell lymphoma in terms of event free~     survival.~   "
156615|NCT01516203|"~     The purpose of this study is to assess the early bacterial activity (EBA) from day 0 to day~     14 of Astra Zeneca Drug (AZD5847) at four different doses and schedules (500 mg once daily,~     500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with~     newly-diagnosed sputum smear positive pulmonary TB. A total of 75 subjects will be enrolled,~     with 15 randomized to each AZD5847 study arm or standard treatment with Rifafour. Duration of~     drug treatment is 14 days.~   "
156793|NCT01513837|"~     Based on the evidence for the common pathway in asthma presentation, our working hypothesis~     is that asthma severity and lack of control are related to the prevalence and severity of~     nasal and sinusal inflammatory pathology, and especially to chronic rhinosinusitis with nasal~     polyps.~   "
156588|NCT01516554|"~     Fatigue is one of the most frequent symptoms reported by multiple sclerosis (MS) patients and~     is often a significant source of disability. Unlike normal fatigue, multiple sclerosis~     related fatigue (MSRF) occurs independently of activity level, suggesting that it is due to~     dysfunction in the neural pathways that regulate the perception of energy although the~     precise cause is still not understood. While MSRF can be managed through lifestyle~     modifications and with drug treatment, these measures are commonly either ineffective or only~     partially effective.~      Administration of the male sex hormone testosterone has been shown to improve energy levels~     in males with testosterone-deficiency states. Testosterone also reduces fatigue in patients~     with other medical conditions not associated with low testosterone levels, suggesting that~     this treatment may also be useful in symptomatic control of MSRF.~      This proposed seven-month long clinical trial is designed to test the hypothesis that~     administration of oral testosterone tablets to male MS patients will result in an improvement~     of fatigue relative to the administration of placebo tablets. As fatigue is frequently~     reported by MS patients to be one of their most frustrating and disabling symptoms, any~     proven additional treatment option for MSRF would be beneficial in improving quality of life.~   "
156589|NCT01516541|"~     This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will~     evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in~     patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated~     risk for cardiovascular disease. Eligible patients will be randomized to receive either~     dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary,~     guidelines-based medical care. Anticipated time on study treatment is 4 years.~   "
156590|NCT01516528|"~     This is a prospective, observational, non-drug interventional, non-randomized study to~     compare the rate of moderate-severe COPD exacerbations in patients of all Chronic Obstructive~     Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A total study~     population of 3330 subjects will be recruited by general practitioners (GPs) and assessed~     over a 27 month time frame.~   "
156591|NCT01516515|"~     This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum~     undatum plant extract in patient with Actinic Keratosis (AK).~   "
156592|NCT01516502|"~     Objective: To compare the effectiveness of application of low-level laser therapy (LLLT) to~     trigger points and traditional acupoints for patients with cervical myofascial pain syndrome~     (MPS).~      Design: A single-blinded, randomized, placebo-controlled trial Setting: University~     rehabilitation hospital Participants: One hundred and twenty one patients with cervical MPS~     Intervention: The investigators performed this experiment using low level 810-nm gallium~     aluminum arsenide (Ga-Al-As) laser. One hundred participants were randomly assigned to four~     treatment groups, including (1) acupoint therapy (2) acupoint control (3) trigger point~     therapy and (4) trigger point control groups.~      Main Outcome measures: The investigators evaluated the patient's visual analogue scale (VAS)~     pain scores, pressure pain threshold and cervical range of motion (ROM) before and after the~     therapy.~   "
156593|NCT01516489|"~     This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial~     incentives directly integrated into primary care can improve fecal occult blood test (FOBT)~     completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs~     Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care,~     $5, $10, $20 incentives will each lead to a statistically significant increase in the rate of~     FOBT completion. We also hypothesize that there will be a direct dose-response relationship~     between the incentive amount and rates of FOBT completion. In stage 2, we hypothesize that a~     lottery-based incentive and a raffle-based incentive will both lead to a statistically~     significant increase in the rate of FOBT completion compared to a fixed payment incentive~     with an equivalent dollar per patient value.~   "
156594|NCT01516476|"~     This randomized, double-blind, placebo-controlled, multi-center study will evaluate the~     efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately~     controlled with metformin alone. Patients will be randomized to receive doses of RO6807952,~     placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.~   "
156595|NCT01516463|"~     Subjects who have minor, second degree burns may be enrolled in this study. Subjects will~     receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals.~     Bandages will be used to keep the burn covered while it heals. Second degree burns generally~     leave a scar. Once the burn heals, lotion and an appropriate bandage will be used to try to~     minimize the appearance of a scar.~      The study hypothesis is that burns treated with Santyl will have a better scar appearance~     than burns treated with bacitracin.~      Subjects enrolled in this study will make once a week visits to the University of Kansas~     Medical Center outpatient burn clinic until the burn heals. The burn will be assessed for~     healing at these visits. Once healed, visits to the clinic will be every 1-3 months for up to~     1 year. At these visits, the appearance of the scar will be evaluated~   "
156596|NCT01516450|"~     This study is an open-label, randomized, 2 parallel group, single dose study in healthy~     Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous~     administration and single subcutaneous administration of GSK1550188. Serial blood samples for~     the determination of GSK1550188 concentration will be collected and safety assessments will~     be performed for each treatment group~   "
156597|NCT01516437|"~     The present study aims to assess the natural immunity to specific microbial antigens in~     healthy subjects and in subjects with stable COPD aged between 45-75 years.~   "
156598|NCT01516424|"~     A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical~     trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone~   "
156599|NCT01516411|"~     The purpose of this research is to test programs to increase physical activity and reduce~     sedentary behavior using motivational messages over a cell phone.~   "
156600|NCT01516398|"~     A lung condition called bronchopulmonary dysplasia (BPD) is a major cause of poor outcomes~     and death for premature infants. Infants with BPD are also at high risk for pulmonary~     hypertension (PH)—an important contributor to their condition. Previous research has~     suggested that a protein in the blood, endothelin-1 (ET-1), is associated with pulmonary~     disease.~      This study aims to investigate the incidence of PH and levels of ET-1 among premature babies~     with BPD. It will also potentially allow us to focus further research efforts and treatment~     towards these infants, some of our sickest patients at LPCH.~   "
156601|NCT01516385|"~     This research looks for markers in the blood of people with spinal cord injury that may be a~     sign of injury severity, or serve as a clue to the degree of recovery. Investigators would~     also like to compare the marker profile of these patient with that of other neurological~     conditions such as stroke and Guillain-Barre syndrome.~      Patients participating in this trial will be those accepted to neuro-rehabilitation in Sheba~     medical center, Israel. They will join the trial at their arrival to the ward, no less than 2~     week after the beginning of their condition, but no later than 3 months.~      Patients will be examined by the research staff three times:~        1. At arrival, the patients will be neurologically examined and their functional abilities~          will be assessed. Blood will be drawn and sent to the lab.~        2. At 6 months after the beginning of the neurological condition the same will be repeated:~          the patients will be neurologically examined and their functional abilities will be~          assessed, and blood will be drawn and sent to the lab.~        3. The final examination will take place 1 year after the beginning of the neurological~          condition. This time only the neurological and functional abilities will be assessed~          without blood tests.~      The blood samples will be tested in the research lab. Then investigators shall compare the~     clinical findings with the laboratory findings, and see if any of the markers found reflect~     the injury severity or predict the recovery.~   "
156602|NCT01516372|"~     This will be a randomized, double-blind, placebo- controlled cross-over study to investigate~     the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive~     control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will take~     part in four dosing sessions. Subjects will receive, in a randomized order, a single dose of~     1200 mg GEn, 6000 mg GEn (supratherapeutic dose), 400 mg moxifloxacin (positive control) and~     placebo. Twelve lead continuous ECG monitoring will be conducted from pre-dose to~     approximately 24 hours after dosing on Day 1 of each study session. The primary comparison of~     interest will be the mean change from baseline in the time-matched differences in QTcF~     between each GEn treatment and placebo.~   "
156603|NCT01516359|"~     The purpose of this study is to investigate the incidence and predictive factors related to~     intestinal injury in patients undergoing heart valve replacement through a multicenter study~     in China.~   "
156604|NCT01516346|"~     The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide~     dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints~     include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity~     (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection~     Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave~     reflections induced by vasoactive therapy will correlate with the improvement in exercise~     capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the~     hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the~     sustained changes in the reflected wave and other hemodynamic parameters in response to~     chronic vasodilator therapy.~   "
156605|NCT01516333|"~     The study is to examine the effect of four diets differing in glycemic index and amount of~     carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.~   "
156606|NCT01516320|"~     The objective of this study is to investigate the different mechanisms by which Gastric~     Bypass (GBP), laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy~     (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in~     gut peptides in the short and long term in morbidly obese patients with Type 2 Diabetes~     Mellitus after GBP, LAGB or VSG. The 2 surgical groups will be compared at 10% equivalent~     weight loss and at after surgery in terms of gut hormones levels, insulin secretion and~     glucose control.~   "
156607|NCT01516307|"~     The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in~     combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects~     with stable disease or response to treatment.~   "
156608|NCT01516294|"~     This study will evaluate the efficacy of IRay treatment in patients with Polypoidal Choroidal~     Vasculopathy (PCV)secondary to AMD as determined by the change in the proportion of lesion~     activity and lesion size at 12 months.~   "
156609|NCT01516281|"~     The purpose of this study is to learn if a new brain imaging technology called DaTscan can~     detect subtle changes in the brain that are similar to those seen in early Parkinson's~     disease (PD). The results of this study may provide more information about a possible~     association between mild to moderate traumatic brain injury (mTBI) and PD. The objectives of~     this study are to define and describe a group of approximately 7,122 mTBI subjects and 7,122~     subjects without mTBI (mTBI-) seen in the Emergency Rooms of NorthShore University~     HealthSystem during the years 2006-2011, and to select from willing eligible subjects a~     random sample of 100 mTBI subjects and 100 mTBI- subjects (of the same age and gender) to~     undergo written informed consent, neurological examinations, blood drawing for DNA extraction~     and storage, and DaTscan brain imaging. The investigators will compare the findings from~     persons who experienced mTBI (cases) to persons without a history of brain injury (mTBI- or~     controls).~   "
156610|NCT01516268|"~     Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound~     guide can reduce narcotic dosage, side effects and pain after cesarean delivery.~   "
156611|NCT01516255|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered~     as positive control.~   "
156612|NCT01516242|"~     This study is conducted in Europe. The aim of the study is to monitor patients changing~     therapy from syringe to insulin delivery system as prescribed by the treating physician in~     Slovakia.~   "
156613|NCT01516229|"~     This study is conducted in Japan. The aim of this study is to assess the incidence rate of~     adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for~     achondroplasia without epiphyseal line closure under normal clinical practice conditions.~   "
156676|NCT01515397|"~     The aim of volume replacement is to compensate a reduction in the intravascular volume e.g.~     during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital~     functions. To achieve this, different plasma substitutes are available: Albumin, dextran,~     hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base~     alterations during elective abdominal surgery can be reduced by the use of a new gelatine~     solution.~   "
156616|NCT01516190|"~     This study is designed to look at the changes that occur in women who take part in exercise~     and Mind-Body programs between breast cancer diagnosis and breast surgery. The investigators~     will look at changes in stress, anxiety, mood and quality of life, to see if these types of~     short programs can make women feel better during this time. The investigators are also~     interested in looking at whether a short exercise or Mind-Body program leads to any changes~     in markers in breast cancer cells, such as their growth and death rates, or in blood hormones~     such as insulin, which have been linked to breast cancer development.~      Since the investigators do not know if these blood or tumor tests have any relationship to~     cancer recurrence, the investigators do not plan to share the results of these tests with you~     or your physician.~   "
156617|NCT01516177|"~     This is an observational study for people who have received a kidney transplant within the~     past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and~     cells in the blood that has been found in a group of rare transplant patients who do not need~     immunosuppression. The study goal is to find out how common this pattern is in transplant~     patients, as a first step in determining if it can be used to personalize anti-rejection drug~     regimens better.~   "
156618|NCT01516164|"~     Videolaryngoscopes offer the potential to make tracheal intubation easier for the~     anaesthetist and less traumatic for the patient. This study aims to compare the intubation~     difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC~     as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen)~     and the MacIntosh laryngoscopes.~   "
156619|NCT01516151|"~     To evaluate the efficacy of 0.5, 1.0, 2.0 and 4.0 g/ day of CaPre™ in reducing fasting plasma~     serum triglycerides over a four week period in patients with mild-to-high~     hypertriglyceridemia as compared to the standard of care alone.~   "
156620|NCT01516138|"~     The purpose of this study is to evaluate the effects of modified glucose - insulin -~     potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).~   "
156621|NCT01516125|"~     The purpose of this research study is to screen healthy African American and Caucasian~     persons for specific differences in genes that control how fats are processed in the body.~   "
156622|NCT01516112|"~     The purpose of the registry is to assess workload of a Home Monitoring based follow up for~     Biotronik ICD and CRTD patients.~   "
156623|NCT01516099|"~     The primary aim of this study is to investigate how a physical activity counselor can offer~     an added value in the sports and exercise promotion in Flanders. The investigators will~     explore if the physical activity counselor, in collaboration with the setting of general~     practitioners and social-cultural associations, can refer sedentary people and persons who~     are active in a non-organized context, into systematic participation in sports and/or~     exercise. Additionally, the investigators want to determine if the physical activity~     counselor will succeed in referring the target population to the local supervised and~     structured sports and exercise activities.~   "
156624|NCT01516086|"~     This will be a multi-center, randomized, placebo controlled parallel-group study to Replicate~     Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects with Partly Controlled~     and Uncontrolled Asthma. Individual participation will be approximately 16 weeks, including~     12 weeks of double-blind treatment.~   "
156625|NCT01516073|"~     This will be a multi-center, randomized, placebo-controlled parallel-group study to evaluate~     nebulized fluticasone propionate (FP) dose response in adult subjects with partly controlled~     and uncontrolled asthma. Individual participation will be approximately 16 weeks, including~     12 weeks of double-blind treatment.~   "
156626|NCT01516060|"~     The purpose is to investigate whether HIV and HIV medication can affect certain areas of~     brain function. This study will look at possible changes in brain function including memory,~     concentration and thought processes to see if there are any differences between the two doses~     of efavirenz used in the Encore1 study and also the level of efavirenz in the blood~   "
156627|NCT01516047|"~     The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult~     male patients with severe hepatic impairment and is being conducted to collect information~     that will support clinical dosing recommendations for this subpopulation.~   "
156628|NCT01516034|"~     The study is designed to determine the efficacy of the Cupola tattoo removal device for~     tattoo removal.~   "
156629|NCT01516021|"~     The aim of the current study was to investigate the effect of a high versus a low fat meal~     (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions.~   "
156630|NCT01516008|"~     The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR~     50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours~     (SPID48) to measure analgesic effect in Korean patients with acute pain following~     bunionectomy.~   "
156631|NCT01515995|"~     The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as~     a vehicle for albuterol in children with moderate to severe asthma exacerbation.~   "
156645|NCT01515813|"~     Since people started taking HIV medications, illnesses related to AIDS have decreased, but~     other serious illnesses like heart disease (heart attacks) and certain kinds of cancer have~     increased. Studies show that HIV causes changes in the lining of the arteries and also causes~     inflammation (irritation) inside the body that may play a role in diseases like heart attacks~     and strokes. The levels of inflammation and artery lining health can also affect how well~     your brain works. These changes cannot be felt, but can be measured. Artery lining health can~     be looked at with a test that uses a blood pressure cuff on your arm to see how the artery~     responds when air is let in and out of the cuff. An ultrasound (machine that uses sound~     waves) is used to look at the artery during the test. This test is called Flow Mediated~     Dilation or FMD for short. Inflammation can be checked with blood tests (blood tests that~     measure this irritation inside the body that you cannot feel). HIV medications can improve~     the artery lining health and can partially lower levels of inflammation in the blood;~     however, these levels of inflammation may not be able to return back to normal.~      Pravastatin sodium is a medication that is approved by the Food and Drug Administration (FDA)~     for treating high cholesterol. Pravastatin sodium has also been able to improve the health of~     the lining of the arteries and lower the level of inflammation in people with other diseases,~     but has not been studied or approved for this purpose in people who have HIV. This research~     study will look at the effects of two types of medications used separately or together on the~     health of the lining of arteries and levels of inflammation in the blood: Atripla (a HIV~     medication) and pravastatin sodium. This study will also look at the effects of Atripla and~     pravastatin sodium on cholesterol levels, tests that measure how well you can think and~     calculate (tests of neurocognitive function), and at the effects of Atripla on the levels of~     pravastatin sodium in the blood.~   "
156646|NCT01515800|"~     RATIONALE: Measuring how text-message affects treatment compliance in women with breast~     cancer may help doctors plan the best treatment.~      PURPOSE: This randomized trial studies how well text-message works in reducing early~     discontinuation of aromatase inhibitor therapy in patients with early-stage breast cancer who~     underwent breast surgery.~   "
156632|NCT01515982|"~     The state of the art with regard to the neurodegenerative dementias, especially for~     Alzheimer´s disease (AD), is that their progression is still irreversible causing cognitive,~     motor, and behavioral impairment. Although the current pharmacological treatments attenuate~     cognitive decline in some cases, the majority of treatments does not avoid the motor and~     functional changes caused by the progress of the disease. Although several studies show that~     exercise has a positive effect when it comes to the treatment of the disease, some~     methodological questions affect the application of the training protocols. The use of~     recognized intensity patterns like maximum oxygen uptake (VO2max) and maximum heart rate~     (HRmax) percentage to control the training of patients with dementia is still rare in the~     literature. Therefore, this seems to interfere on the definition of an ideal prescription.~     Following this line of reasoning, the purpose of the present study is to assess the effect of~     moderate aerobic exercise on cognition and functional abilities in AD patients. Design:~     Randomized controlled trial, double-blinded, with 16-week follow-up. Setting: Center for~     Alzheimer's disease in the Institute of Psychiatry of the Federal University of Rio de~     Janeiro. Participants: Elderly with Alzheimer disease. Interventions: The patients will be~     randomly assigned to an exercise group (EG) on a treadmill (30 minutes, twice a week and~     moderate intensity of 60% VO2max) and a control group (CG). Main outcome measures: Cognitive~     function will be assessed using CAMCOG, Trail Making Test A, Digit Span, Stroop Test, Rey~     auditory-verbal learning test and Clock Test, and functional capacity will be evaluated using~     Berg Balance Scale (BERG), Sit-to-Stand test (STS), functional reach test (FR), and the time~     to up and go test (TUGT).~   "
156633|NCT01515969|"~     This phase I trial studies the side effects and best dose of giving erlotinib and dovitinib~     together to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks the~     epidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancer~     and dovitinib blocks the fibroblast growth factor receptor (FGFR) and other targets which may~     be important to treat lung cancer. The combination of both drugs may work better than either~     drug alone, but may also have increased side effects. This trial will look at the side~     effects of combining the drugs and look for how effective the combination may be.~   "
156634|NCT01515956|"~     This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk~     infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of~     administration of the first dose of study drug, diagnosed with MPS IVA (Morquio A Syndrome)~     for up to 208 weeks.~   "
156635|NCT01515943|"~     The purpose of this study is to determine the effectiveness of home-based computer therapy~     for symptomatic convergence insufficiency (CI) compared to traditional home-based near target~     push-ups and placebo treatment.~   "
156636|NCT01515930|"~     The purpose of this study is to develop an intervention to increase parental motivation for~     supervision and monitoring youth diabetes care behavior. The intervention will be tested in~     three brief session in conjunction with regularly scheduled diabetes clinic visits and~     delivered through a computer program based in the principles of Motivational Interviewing.~   "
156637|NCT01515917|"~     This is a placebo-controlled study intended to examine the effects of the neutraceutical~     citicholine, together with omega-3 fatty acids, on a range of measures in individuals with~     concussive head injury, often referred to as traumatic brain injury, or TBI. The study will~     consist of three visits, during which participants will complete brain scans, a thorough~     testing battery and a clinical interview to assess mood and other diagnostic information~     relevant to the study.~   "
156638|NCT01515904|"~     In January 2010 a new interdisciplinary clinic (STOMP) was created to provide care for~     children and adolescents with severe 'complex' obesity. As part of the program, a subset of~     adolescents undergo bariatric surgery. There is a paucity of literature evaluating outcomes~     of children and adolescents participating in a 'clinical' setting and even fewer reports of~     outcomes of severely obese pediatric patients. Previously, the investigators evaluated~     clinical outcomes of children with craniopharyngioma and hypothalamic obesity attending an~     outpatient interdisciplinary program at SickKids (The Comprehensive Care Clinic for Children~     with Central Tumours) and found significant benefit to those attending, including reduction~     of weight gain (or weight loss), improved psychosocial functioning, and increased care~     satisfaction. STOMP is a natural extension of this program, incorporating some core elements~     (e.g., interdisciplinary team, frequent visits, individualized care plans for~     medically-complex adolescents) and building on other aspects, such as increased psychosocial~     intervention; involvement of a key worker (nurse practitioner) to support families;~     provision of continuity of care with other health providers in all settings, community~     services and schools; a more diverse patient population; and group support sessions.~     Evaluation of the outcomes of this clinic is needed to inform best practice for children and~     adolescents with severe complex obesity~   "
156639|NCT01515891|"~     To determine the absorption, metabolism and excretion of BIA 9-1067.~   "
156640|NCT01515878|"~     It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves~     long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and~     by reduced incidence of intradialytic hypotensive episodes~   "
156641|NCT01515865|"~     To study the effect of midodrine against the symptoms of orthostatic hypotension~   "
156642|NCT01515852|"~     Examination of stress level in general anesthesia in comparison to local anesthesia in~     stereotactic biopsy~   "
156643|NCT01515839|"~     The investigators primary objective is to acquire preliminary data on one-hundred former NFL~     veterans with at least one full year of professional service using brain SPECT imaging in~     order to assess the degree to which NFL football puts players at risk for traumatic brain~     injury (TBI). TBI severity shall be gauged via visual inspection by a clinician trained in~     neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house~     proprietary database comprised of the brains of healthy subjects.~      The investigators secondary objective is to acquire additional data on these players such~     that investigators may establish causative factors and risks associated with said TBI.~      The investigators tertiary objective is to acquire data on subjects using various mental~     health metrics in order to determine the effects of TBI.~   "
156644|NCT01515826|"~     The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate~     0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%)~     ophthalmic solution in the prevention of postoperative inflammation and infection.~   "
156647|NCT01515787|"~     The standard treatment for locally advanced rectal cancer involves chemotherapy and~     radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation~     therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and~     important part of treatment for rectal cancer and has been shown to decrease the risk of the~     cancer coming back in the same area in the pelvis, some patients experience undesirable side~     effects from the radiation and there have been important advances in chemotherapy, surgery,~     and radiation which may be of benefit. The purpose of this study is to compare the effects,~     both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy~     using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin~     and leucovorin) and selective use of the standard treatment, depending on response to the~     FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved~     and have been used routinely to treat patients with advanced colorectal cancer.~   "
156648|NCT01515774|"~     1. In order to observe the benefit, side effects, and patient preference of Mirapex ER when~          used in once-daily (QD) or twice-daily (BID) dosing~        2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER~   "
156649|NCT01515761|"~     The primary objective is to determine if lead positioning in the lateral wall of the left~     ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in~     determining myocardial function and affects the severity of mitral regurgitation.~   "
156650|NCT01515748|"~     Primary Objective:~      - To compare progression free survival (PFS) in the two treatment arms~      Secondary Objectives:~        -  Overall survival (OS)~        -  Postoperative stage and R0 (complete) resection rate~        -  Safety: Toxicities associated with neoadjuvant chemotherapy, surgery,~          morbidity/mortality, toxicity of adjuvant chemotherapy1~   "
156651|NCT01515735|"~     To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with~     pseudoexfoliation syndrome in the Korean population, Genotypes of lysyl oxidase-like 1 gene~     were analyzed by direct sequencing.~   "
156652|NCT01515722|"~     Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the~     medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to~     improve treatment outcomes~      Study Hypothesis: Health Education Intervention (HEI) can enhance the medication compliance~     and persistence, thereby can improve the treatment outcomes in conjunction with~     pharmacological therapy in OAB patients~      Study Design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals~   "
156653|NCT01515709|"~     Patients with Chronic Obstructive Lung Disease (COPD) often develop muscle problems,~     particularly in their legs which makes them more limited in what they can do. The Short~     Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed~     and ability to stand from a chair. The SPPB may be a useful measure to predict leg function.~      This study aims to evaluate whether the SPPB is comparable with current exercise tests used~     in COPD patients, and whether it is useful in predicting disability, death and health~     resource usage over time.~   "
156654|NCT01515696|"~     Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be~     applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect~     otherwise radiologically invisible perforations or an insufficient GIT anastomosis after~     surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a~     strong osmotic effect and leads to water influx into the intestine lumen. Thereby the~     peristaltic movement is accelerated and the premature infant excretes stool during the hours~     following application. Therefore Gastrografin might be effective to mobilize meconium from~     small bowel and deep parts of the colon. The investigators hypothesized that enteral~     application of Gastrografin accelerates meconium evacuation in premature infants, and thereby~     enhances feeding tolerance in this population.~   "
156655|NCT01515683|"~     Studies shows that reduced nervousness before anaesthesia may improve a course past~     anaesthesia. Therefore it is interesting to investigate how we can best help patients shortly~     before anaesthesia. A RCT with three intervention arms (with different personal support) and~     a control arm (with usual personal support) is therefore performed.~      Hypothesis: Nervousness is reduced by the new interventions compared to the usual help~     provided.~   "
156656|NCT01515670|"~     The purpose of the study is to determine the influence of preoperative co-morbidity in~     relation to increased length of stay and postoperative complications in patients receiving~     fast-track hip or knee replacement.~   "
156657|NCT01515657|"~     This study will determine if aspirin from PL2200, an investigational product, gets into the~     blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether~     PL2200 is able to prevent blood clots as effectively as these other products, when~     administered to patients with diabetes.~   "
156658|NCT01515644|"~     In this study the effect of Infant formula with added Inulin will be compared with the effect~     of Infant formula without Inulin on the Bifidobacterium level in stool.~      It is expected that drinking Infant formula with added Inulin will result in higher~     beneficial bacteria level in stool compared to an Infant formula without Inulin.~   "
156659|NCT01515631|"~     Patients who have Alagille Syndrome (AGS) also frequently have blockages (or stenoses) of~     their pulmonary arteries. Little is known about the degree or variability of these stenoses,~     or the effect of this disease on the right ventricle (the chamber of the heart which pumps~     blood to the lungs). This study will first quantify and describe pulmonary artery stenosis in~     patients with Alagille Syndrome. The study will also assess the effect of these stenoses on~     the right ventricle. The investigators hope to learn the degree and characteristics of~     pulmonary artery stenosis in Alagille Syndrome. The investigators also hope to learn the~     effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille~     Syndrome. This information is critical in the management of patients with Alagille syndrome,~     as there is currently no data to guide clinicians on the management of pulmonary artery~     stenosis. Furthermore, the information from this study may help physicians manage pulmonary~     artery stenosis in other patients as well.~   "
156675|NCT01515410|"~     The primary objective of this study is to explore the efficacy and tolerability of DM-1992~     compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as~     measured by:~        -  ON time with no dyskinesia or non-troublesome dyskinesia~        -  OFF time~   "
156677|NCT01515384|"~     The purpose of this study is to evaluate the safety and pancreas imaging properties of~     18F-AV-133.~   "
156660|NCT01515605|"~     Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or tissue~     from patients after kidney transplantation. In the present study the investigators examine~     the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after~     transplantation.~      Routine clinical and laboratory data from serum and urine are evaluated at baseline and after~     0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years after kidney transplantation.~     Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes~     (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting~     T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase),~     TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential~     cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated~     gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3),~     MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using~     standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques.~     Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected~     genes are analyzed using standard techniques. Data are analyzed by descriptive statistics.~     Differences between groups were analyzed using Mann-Whitney test or Kruskal-Wallis-test and~     Dunn`s multiple comparison post-test, as appropriate. Associations between variables are~     analyzed using regression analyses. Contingency tables are analyzed using Fisher's exact~     test.~   "
156661|NCT01515592|"~     This trial is conducted in Japan. The aim of this trial is to assess the safety and~     tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.~   "
156662|NCT01515579|"~     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the~     phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7~     (formulation 3).~   "
156663|NCT01515566|"~     The goal of this clinical research study is to learn if fentanyl given under the skin can~     reduce shortness of breath in cancer patients. Researchers also want to learn if it can help~     to improve your physical function. In this study, fentanyl will be compared to a placebo.~      Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with~     their shortness of breath as well.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
156664|NCT01515553|"~     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the~     phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned~     for phase 3b trials (final formulation 4).~   "
156665|NCT01515540|"~     The investigators tested whether pain decrease can be observed centrally with non-invasive~     brain imaging in CBP subjects receiving Lidoderm. The investigators first tested effects of~     5% Lidoderm patched in an open labelled trial. Next the investigators compared the effects of~     Lidocaine versus Placebo patches. Three time points were evaluated: baseline (before~     treatment) and 6 hours and 2 weeks after treatment. The latter trial was a 2 arm, double~     blind, placebo controlled trial, where participants either received Lidoderm or placebo~     patches, without cross over.~   "
156666|NCT01515527|"~     The goal of this clinical research study is to learn if cladribine given in combination with~     low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML~     or MDS. The safety of this drug combination will also be studied.~      Cladribine is designed to interfere with the cell's ability to process DNA (the genetic~     material of cells). It can also insert itself into the DNA of cancer cells to stop them from~     growing and repairing themselves.~      Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing~     and repairing themselves.~      Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.~      This is an investigational study. Cladribine is FDA approved and commercially available for~     use in patients with hairy cell leukemia. Its use in patients with AML is investigational.~      Cytarabine is FDA approved and commercially available for use in patients with AML.~      Decitabine is FDA approved and commercially available for use in patients with MDS. Its use~     for patients with AML is investigational.~      Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.~   "
156667|NCT01515514|"~     The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to~     endoscope in comparison to standard free-hand image acquisition.~   "
156668|NCT01515501|"~     Patients undergoing routine rectal suction biopsy will undergo as part of the study an~     additional Endoscopic mucosal resection. The biopsy results will also be correlated with~     patient's clinical data including clinical history, Bristol stool scale, anorectal manometry~     results, and SITZ marker studies. Cost and recovery time will be compared.~   "
156669|NCT01515488|"~     An audio-assisted self-triage kiosk in the Pediatric Emergency Department (ED) is expected to~     significantly reduce triage times, without any sacrifice of the quality of information that~     would be obtained by nurse-initiated triage.~   "
156670|NCT01515475|"~     The purpose of this study is to compare visual acuity outcomes and development of strabismus~     after a 3-year follow-up period in children age 12 to <72 months with moderate hyperopia~     (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only~     after confirmation of pre-specified deterioration criteria.~   "
156671|NCT01515462|"~     This is phase I/II protocol to evaluate the safety and efficacy of WAS gene transfer into~     hematopoietic stem/progenitor cells for the treatment of Wiskott Aldrich Syndrome.~   "
156672|NCT01515449|"~     The aim of the project is to ascertain the pre and intra operative predictors of poor~     outcomes in total knee replacement.~   "
156673|NCT01515436|"~     The purpose of this study is to determine if having children listen to the music of Wolfgang~     Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike~     discharges on his/her Electroencephalography (EEG). These spike discharges often occur during~     a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with Centrotemporal~     Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the amount of spike~     discharges after listening to Mozart's music, this information may lead to new understanding~     and possible treatments for epilepsy.~   "
156674|NCT01515423|"~     The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation~     (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the~     treatment of patients with schizophrenia who have been stabilized on PP1M.~   "
156682|NCT01515319|"~     Obesity causes 600 premature deaths per week in the UK and existing treatments are not~     effective. When humans eat, the bowels naturally secrete chemicals into the bloodstream which~     make people feel full and which stop eating. One of these chemicals is known as Peptide YY~     (PYY). The investigators have previously shown that injections of PYY reduce appetite and~     food intake in human volunteers. The investigators have now developed a very similar~     chemical, Y242, as a treatment for obesity. Y242 has been tested in animals and has been~     shown to be safe, to reduce their appetite, and to last for much longer than PYY itself. This~     study will test Y242 to ensure that it is well tolerated in humans, and to see how long it~     lasts in the blood stream after being injected under the skin. It will also look for any~     effects on appetite.~   "
156683|NCT01515306|"~     The purpose of this study is to investigate whether there are no clinically significant~     pharmacokinetic effects of concomitant ramucirumab (IMC-1121B) on paclitaxel by investigating~     the pharmacokinetics (PK) of each in participants with advanced malignant solid tumors.~      Part A of this study will investigate the potential of concomitant ramucirumab (IMC-1121B) to~     affect the pharmacokinetics of paclitaxel. Part B of this study will investigate the~     pharmacokinetics of ramucirumab (IMC-1121B) as monotherapy.~   "
156684|NCT01515293|"~     The aim of this study is to compare the short-term outcomes of single-incision and~     conventional laparoscopic appendectomy.~   "
156685|NCT01515280|"~     The aim of this study is to have those patients taking part in the Clinical trial-: A~     Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of~     Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire~     (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment~     period. The investigators hope to demonstrate a clinically significant change in HARQ scores~     of at least 16 points from before and after treatment. Furthermore the investigators would~     hope to show a significantly improved HARQ score in patients on the BC036 arm of the study~     compared to the placebo arm.~   "
156686|NCT01515267|"~     Left ventricular ejection fraction (EF) is evaluated in every echocardiographic examination~     either by visual estimation (eyeballing) requiring high level of training and expertise~     and/or by manual tracing of the endocard from which EF is calculated (manual biplane method~     (MBP)). This procedure is subjective and time consuming. The objective of this study is to~     compare the performance of LVivoEF software system to the measurements obtained by the~     routinely used methods.~   "
156687|NCT01515254|"~     In this study the investigators will examine the Feeding Dynamic Intervention (FDI) as a tool~     to prevent obesity in young children. The purpose of the intervention is to improving~     caregiver feeding practices, child eating behaviors, and child self-regulation of energy~     intake in the short term.~   "
156688|NCT01515241|"~     Despite the availability of several classes of very effective drugs available to treat~     heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need~     for new, effective and well tolerated therapies. There are a number of therapies given on a~     chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty~     acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs, but~     subjects with heterozygous Familial Hypercholesterolemia remain at high risk for~     cardiovascular events. There is still a need for acute therapies that can lead to rapid~     pacification of unstable plaque in order to reduce the risk of these events. This study will~     assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of~     atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and~     intravascular ultrasound (IVUS) evaluations in patients with HeFH.~   "
156689|NCT01515228|"~     The purpose of this study is to examine the safety and effectiveness of coronary stenting~     with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic~     patients.~   "
156690|NCT01515215|"~     Major Depressive Disorder (MDD) is one of the most prevalent mental illnesses in North~     America, in which 30% - 40% fail to respond to conventional treatment. Repetitive~     Transcranial Magnetic Stimulation (rTMS) has been shown to be an effective therapeutic tool~     for the treatment of MDD. This form of treatment involves a series of magnetic pulses~     directed to the brain for about 30 minutes. Importantly, such treatment is very safe and well~     tolerated. However, to date, most treatment studies show modest efficacy due to limitations,~     including: 1) treatments that are delivered to only one side of the brain; 2) treatment that~     does not directly target a specific brain region associated with depression; 3) treatments~     that are of short duration; 4) treatments that are of insufficient intensity; and 5)~     insufficient understanding of the brain mechanisms responsible for therapeutic effect. This~     study is designed to directly address all of these limitations, as well as explore brain~     mechanisms (e.g. cortical excitability) through which treatment is optimized.~   "
156691|NCT01515202|"~     The purpose of this clinical study is to assess the safety and tolerability of multiple oral~     doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes~     Mellitus.~   "
156692|NCT01515189|"~     The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will~     extend the lives of subjects with unresectable or metastatic melanoma more than giving~     Ipilimumab at a dose of 3 mg/kg~   "
156693|NCT01515176|"~     This phase I/II trial studies the side effects and the best dose of ofatumumab and dinaciclib~     and to see how well they work in treating patients with relapsed or refractory chronic~     lymphocytic leukemia, small lymphocytic lymphoma, or B-cell prolymphocytic leukemia.~     Monoclonal antibodies, such as ofatumumab, can find cancer cells and help kill them.~     Dinaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving ofatumumab together with dinaciclib may kill more cancer cells.~   "
156694|NCT01515163|"~     The investigators hypothesize that a three-month aerobic exercise training program will~     positively affect the lipid profile, insulin sensitivity , cytokine profile, the~     cardiovascular parameters and muscle strength in SLE patients.~   "
156695|NCT01515150|"~     Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated~     diverticulitis has a very low risk (1.4%) of developing severe complications such as~     perforations or abscesses. The question is whether or not hospitalization is necessary, and~     if patients in that case could return home without antibiotics.~      The purpose of this study is to evaluate if out-patients managements in uncomplicated colonic~     diverticulitis is possible without readmission or complications.~   "
156696|NCT01515137|"~     This trial was originally designed and powered to compare biomarker modulation in the~     neo-adjuvant setting (erlotinib versus erlotinib plus sulindac versus placebo) with clinical~     response to erlotinib in the adjuvant setting. Since implementing the trial in late 2005, The~     investigators have encountered significant obstacles to implementing the adjuvant therapy~     phase of the trial.~        -  Barriers included:~             1. disease recurrence~             2. patient refusal to take the agent~             3. patient refusal to travel to Pittsburgh for clinical evaluations.~      Given the institutional challenges to implement and complete the adjuvant portion, the~     investigators have decided to change the primary endpoint to a biomarker modulation endpoint.~     To achieve this goal, the investigators determined that they needed 39 paired tissue~     specimens (see statistical justification below).~      The central hypothesis to be tested in this study is that persistent activation of parallel~     and/or downstream pathways contributes to tumor progression in the setting of EGFR blockade.~     While not all head and neck squamous cell carcinoma (HNSCC) patients will respond to EGFR~     targeting, the optimal strategy to identify those subjects whose tumors are sensitive to EGFR~     inhibition remains unknown.~      The primary objective is centered around the concept of tumor biomarkers which may be~     modulated by EGFR and Cox-2 inhibitors and may serve as future therapeutic targets for~     therapy. To this end patients on this trial will be randomly assigned to one of three arms to~     receive either Tarceva, Tarceva plus sulindac, or a placebo in the 2 week pre-operative~     period. A panel of biomarkers will be obtained by biopsy prior to pre-operative therapy and~     again at surgery. Biomarkers will be examined for modulation in the 2-week pre-operative~     period, for group differences, for treatment effects and for further understanding of protein~     signaling pathways.~      Sample size for the primary objective~      Modification of Statistical Design:~      The primary endpoint is the difference between pre (biopsy) and post (surgery). There are 3~     hypotheses of interest: (1) placebo vs erlotinib alone, (2) placebo versus erlotinib plus~     sulindac, and (3) erlotinib vs erlotinib + sulindac. With a randomization in a 3:5:5 ratio,~     we have 88% power, alpha = .01 for an omnibus test to show between-group differences of 1 log~     exist. This requires 39 patients. Basically, 39 patients will provide the ability to detect a~     one log difference between any 2 of the 3 groups in pre-post change.~   "
156697|NCT01515124|"~     WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer~     survivors who are overweight or obese with breast cancer related lymphedema. There will be~     four groups in this trial: exercise only, weight loss only, exercise and weight-loss~     combined, and a control group. The purpose of this study is to test the effects of these~     interventions on lymphedema outcomes, breast cancer recurrence and quality of life.~      The cost analysis sub-study - will assess the cost-effectiveness of conducting the WISER~     Survivor interventions and also model the impact of the WISER Survivor interventions over an~     extended time frame.~   "
156698|NCT01515111|"~     A national cross-sectional survey was conducted to evaluate recommendations on clinical~     preventive services and additional information on non-communicable disease prevention.~     Trained surveyors interviewed interns, residents and attendings of the Internal Medicine~     departments of all teaching hospitals in Guatemala. Analysis compared recommendation~     practices within and between hospitals.~   "
156699|NCT01515098|"~     Purpose: The purpose of this study is to examine the effect of blueberry consumption on~     cognitive decline and body composition in humans.~      Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an~     improvement in cognitive abilities as measured by a standardized battery of tests, relative~     to those who consume a placebo.~      Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an~     increase in processing speed and an improvement in memory abilities as measured in an~     electrophysiological paradigm and compared to those who consume a placebo.~      Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition~     (fat mass vs. lean mass).~      Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress~     and inflammatory markers.~   "
156700|NCT01515085|"~     Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or~     radiation give patients a beneficial increase in overall survival? Laser induced thermal~     therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of~     heat.~   "
156701|NCT01515072|"~     The purpose of this study is to determine whether application of lower limb remote ischemic~     preconditioning (RIPC) after determination of brain death improves donor stability, organ~     quality, organ yield, and early post transplant clinical outcomes.~      Neurological death donors will be stratified into standard and extended criteria donors~     (SCD/ECD) and randomized in a 1:1 fashion to RIPC or No intervention. The primary outcome is~     the number of organs recovered per donor. Secondary outcomes include donor hemodynamic state,~     donor organ-specific function parameters, pulsatile perfusion parameters, number of organs~     transplanted per donor, recipient hospital free survival and delayed graft function of~     kidneys. The sample size is powered to detect a difference of 0.44 organs recovered.~   "
156702|NCT01515059|"~     It is well established that bariatric (weightloss) surgery affords considerable improvement~     in glycaemic control (control of blood sugar), and in many cases may lead to a complete~     resolution of type 2 diabetes. However, the mechanisms underlying these changes are yet to be~     elucidated and no research project to date has attempted to characterise changes in glycaemic~     control sooner than 3 days post surgery.~      The primary objective of this study is to characterise changes in glycaemic control in~     individuals immediately following such surgery for a period of five days. Participants will~     be fitted with a continuous blood glucose measurement system (CGMS) prior to leaving theatre,~     which electronically records their blood glucose concentration every minute for up to five~     days. Upon returning the device each participant will undergo a standard meal test and have a~     small blood sample taken at 30 minute intervals (0-120 minutes) for the quantification of~     incretins (gut hormones involved in medium term control of blood sugar) insulin, glucose and~     appetite hormones.~      These measurements will be compared to those collected at the baseline session, three weeks~     prior to the patient's surgery. Additional baseline visit measurements include: fasting lipid~     profile, insulin concentration, blood glucose concentration, HBA1C (long term blood glucose~     measurement), blood pressure, height, weight, waist circumference, and an oral glucose~     tolerance test (OGTT) and medical and family history.~      All patients will be followed up twelve weeks post surgery, during which, all baseline~     measurements will be repeated.~   "
156703|NCT01515046|"~     This is a phase II study. It is designed to provide information about if high-dose ascorbate~     (vitamin C) increases survival for pancreatic cancer patients. The hypothesis is that vitamin~     C is well tolerated and increases cancer treatment effectiveness, lengthening survival time~     for patients with advanced pancreatic cancer.~   "
156704|NCT01515033|"~     The purpose of the present study was to evaluate: 1) the effects of continuous exercise~     training and interval exercise training on end-tidal carbon dioxide pressure (PETCO2)~     response during graded exercise test in patients with coronary artery disease; and 2) examine~     the effects of exercise training modalities on the association among PETCO2 at ventilatory~     anaerobic threshold (VAT) and indicators of ventilatory efficiency and cardiorespiratory~     fitness in patients with coronary artery disease.~   "
156705|NCT01515020|"~     Hypothesis: The use of daptomycin to treat nosocomial or healthcare-associated bacteremia due~     to methicillin-resistant S. aureus (MRSA) would increase the proportion of patients whose~     blood cultures are sterilized after 72 hours by 15% relative to vancomycin and would improve~     treatment safety.~      Hypothesis: for MRSA nosocomial or healthcare related bacteriemia treatment, the use of~     daptomycin versus vancomycin would increase by 15% the proportion of patients with sterilized~     blood cultures at 72 hours and would increase the treatment safety.~      Primary objective: To study the efficacy of daptomycin compared to vancomycin on the~     sterilization of blood cultures after 72 hours of therapy.~   "
156706|NCT01515007|"~     This study (ARD-3150-1201, ORBIT-3) will evaluate the safety and efficacy of inhaled~     Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects~     who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history~     of pulmonary exacerbations and chronic P. aeruginosa infections.~   "
156707|NCT01514994|"~     The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase,~     observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring~     Balloon Catheter for the treatment of critical aortic valve stenosis.~   "
156708|NCT01514981|"~     The purpose of this study is to determine that no significant safety issues will be~     identified following a single dose of AMG 761 in asthma subjects that would preclude further~     development of AMG 761.~   "
156709|NCT01514968|"~     This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect~     of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy~     volunteers. Subjects will be randomized to one of two treatment sequences to receive a single~     oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single~     oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.~   "
156710|NCT01514955|"~     Main cause of mortality in cervix cancer is local relapse in the pelvis. Since distant~     metastasis is quiet rare, increasing local control in the pelvis can directly translate into~     improvement in survival. Obstacles in front of this approach is the dose limitation to normal~     organs located in the pelvis adjacent to the tumor. 3-D MRI based EBRT and Brachytherapy will~     grant safe delivery of more conformal higher doses of radiation to the tumor and allowing~     sparing of the normal structures.~   "
156711|NCT01514942|"~     Insulin resistance has important implications in the pathogenesis of the polycystic ovary~     syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.~      Reduction of insulin levels with administration of insulin sensitizing agents has been found~     to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring~     ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely~     used in the long term treatment of women with PCOS in whom it modifies the ovarian~     morphology, improves intraovarian androgen levels, and enhances systemic and local insulin~     resistance. Despite to these beneficial effects, several side effects have been reported due~     to the long term administration of this drug.~      In the recent years, inositol has found more and more space in the reproductive clinical~     practice. Indeed, inositol have been classified as insulin sensitizing agent and it is~     mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in~     particular several studies on Myo-inositol and D-chiro-inositol were reported.~      In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in~     women with PCOS and with or without insulin resistance.~   "
156712|NCT01514929|"~     The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the~     QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase~     in the QT interval.~   "
156713|NCT01514916|"~     The medical device Vascular Join represents a new anastomotic technology that should reduce~     the inter-surgeons variability in anastomosis construction and increase the performances in~     terms of results. It allows a perfect mechanical anastomosis without suture, avoiding the~     disadvantages of operation length and difficulty of the act, thrombosis, clamping and~     embolism. The Vascular Join creates automatically the connection between the vein or~     prosthesis at both ends and bridging the artery while preventing the passage of the needle~     and suture through the vessel wall and clamping pressure. This makes it very easy to~     construct a vascular anastomosis using the endoscopic technique less traumatic for the~     patient, lessen the pain of the patient, thereby reducing health care costs by reducing the~     length of hospital stay.~      No part of the device is in contact with the patient's blood because the whole system remains~     in the thickness of the arterial wall and outside the vessel. Thus, the formation of intimal~     hyperplasia is greatly diminished and the risk of occlusion of the anastomosis is less than~     the currently available risk when a suture is used. This risk is shown by studies on animals~     in labs, with a mean follow up of 12 months. The Vascular Join creates a perfect congruence~     of anastomosed vessels because it allows a perfect match between each vascular tunic.~      The medical device Vascular Join has been designed in order to:~        -  Reduce the suture time;~        -  Reduce the risk of occlusion of vein after the surgical process;~        -  Avoid the contact risk between the external material steel (surgical needle) and blood;~        -  Standardize the quality of anastomoses independently of the skill of the surgeon.~   "
156714|NCT01514903|"~     This is a single dose open-label comparative pharmacokinetic study to assess the~     pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra~     (tablet) in healthy male subjects.~   "
156715|NCT01514890|"~     The purpose fo the study is to evaluate the efficacy defined by the sustained virological~     response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and~     telaprevir or boceprevir in the French Early Access Program for the use of protease~     inhibitors or after the approval of these drugs through the the marketing authorization.~   "
156716|NCT01514877|"~     The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT~     in treating patients with multiple brain metastases from NSCLC.~   "
156717|NCT01514864|"~     The purpose of this study is to establish whether patients with malignancy harboring a~     discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to~     dasatinib.~   "
156718|NCT01514851|"~     To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum~     Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized,~     double-blind, parallel group study in comparison with Calcium carbonate.~   "
156722|NCT01514799|"~     Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is~     not always enough. Bypassing a longer segment of the gut may be more beneficial. Which part~     to bypass is not clear.~      The investigators want to compare the effects between preventing a proximal (oral) portion of~     the jejunum from food contact with the effects when preventing the jejunum from contact with~     bile and pancreatic juice.~      Endpoints are quality of life, gstrointestinal function, and weight development.~   "
156723|NCT01514786|"~     Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of~     multiple competing demands. A decision aid (DA) that clarifies patient preferences and~     improves decision quality could aid shared decision making (SDM) and be effective at~     increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year~     R01 study funded by the National Cancer Institute seeks to provide detailed understanding of~     how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS~     adherence.~   "
156724|NCT01514773|"~     To better understand the reasons for underutilization of defibrillator therapy in selected~     populations, the investigators propose a study to assess heart failure patient knowledge and~     attitudes toward device therapy. By carefully studying populations of patients with systolic~     heart failure, the investigators aim to identify the underlying reasons for implantable~     cardioverter defibrillators (ICD) non-utilization in patients with symptomatic systolic heart~     failure.~   "
156725|NCT01514760|"~     Investigators from University of Arkansas for Medical Sciences Department of Pediatrics and~     University of Arkansas for Medical Sciences Center for Distance Health will collaborate to~     develop a mobile-based Asthma Action Plan application to improve asthma self-management~     skills specifically targeting adolescents. The investigators hypothesize that an interactive,~     mobile-based asthma action plan will be a feasible means of reinforcing long-term asthma~     management guidelines as well as delivering acute management instructions to adolescents with~     asthma.~   "
156726|NCT01514747|"~     Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the~     US. These babies often have motor and/or visual problems when they grow up. It is very~     important to identify high risk ELBW infants as early as possible, so that the investigators~     can treat them earlier to prevent poor development. Neurological examination at early age is~     not good enough to identify high risk ELBW infants. One the other hand, some magnetic~     resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state~     functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and~     visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at~     a very early age to predict long−term outcome and to identify infants who are at high risk of~     having motor and/or visual problems when they grow up.~   "
156727|NCT01514734|"~     The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®~     from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular~     hypertension.~   "
156728|NCT01514721|"~     The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav®~     (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination~     pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with uncontrolled~     intraocular pressure (IOP).~   "
156729|NCT01514708|"~     The purpose of this study is to evaluate the antibody response to the influenza vaccine~     (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization in~     pregnant women in compliance with the requirements of the current European Union (EU)~     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed~     flu vaccine (CPMP/BWP/214/96). Besides, the vaccine safety will also be evaluated.~   "
156730|NCT01514695|"~     The purpose of this study is to determine whether conscious sedation with a narcotic and~     sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy~     to achieve optimal patient comfort and ease of procedure.~   "
156731|NCT01514682|"~     Despite current antipsychotic treatment, the majority of people with schizophrenia continue~     to exhibit persistent positive and negative symptoms and cognitive impairments. An~     alternative approach to the use of psychotropic agents for the treatment of persistent~     symptoms is the use of anti-inflammatory agents to reverse the pro-inflammatory state~     hypothesized to underlie the symptom and sign manifestations of the illness.~      The investigators primary hypothesis is that add-on anti-inflammatory combination therapy~     will have significant beneficial effects on persistent positive symptoms and cognitive~     impairments.~      The investigators secondary hypotheses are:~        1. add-on anti-inflammatory combination therapy will be associated with improvements in~          depressive and negative symptoms and a reduction in pro-inflammatory cytokines~        2. add-on anti-inflammatory combination therapy compared to placebo will not be associated~          with elevated adverse risk.~   "
156732|NCT01514669|"~     The purpose of this research study is to compare profiles in the blood and tears of patients~     with and without prostate cancer with the goal of developing a method of separating men with~     aggressive and non-aggressive disease.~   "
156733|NCT01514656|"~     Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival~     for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than~     one third of witnessed SCA events. A number of barriers to bystander CPR training have been~     identified including time and cost of the training course. Since the large majority of arrest~     events occur in the home environment, studies have suggested that providing CPR training to~     family members of hospitalized cardiac patients may serve as a useful approach to address an~     environment in which bystander CPR is frequently not provided. Utilizing an existing~     in-hospital program to train adult family members, the investigators will assess the skills~     of those who learn CPR through two different education methods (video-only and video~     self-instruction (VSI) kit).~   "
156734|NCT01514643|"~     The purpose of the study is to investigate a relationship between the inflammatory response~     following intraarticular fracture and post-traumatic osteoarthritis. The investigators plan~     to evaluate the inflammatory cytokine profile in knee joint synovial fluid and blood serum in~     patients who sustain an intraarticular tibial plateau fracture and ankle joint synovial fluid~     and blood serum in patients who sustain an intraarticular tibial plafond fracture. This~     information will be combined with radiographs and patient outcome measures to determine a~     correlation between intraarticular inflammatory response and post-traumatic osteoarthritis.~   "
156735|NCT01514630|"~     Methamphetamine (MA) is a psychostimulant drug with high abuse potential. MA can be smoked,~     snorted, injected or ingested orally to produce a release of high levels of dopamine into the~     brain and reduction of dopamine uptake. Its use results in feelings of pleasure, increased~     energy, and greater alertness lasting up to 12 hours. In 2010, the National Survey on Drug~     Use and Health reported that 353,000 Americans aged 12 or older reported being current MA~     users. Over the past decade MA use rates have fluctuated with current use rates on the~     decline; however, importantly, even though overall use rates are declining, use rates among~     males and females are approaching equal proportions. This use rate pattern is unlike other~     drugs of abuse, which typically demonstrate males using more than females. In some states,~     more females than males consider MA as their drug of choice. Namely, in a 2010 report in the~     state of Utah, more females were diagnosed with MA as a primary substance of abuse than males~     upon admission to treatment.~      Depression and MA use are highly comorbid. The relationship between MA use and depression is~     likely bidirectional, with MA use causing changes in mood and being used as a self-medicating~     behavior to reduce symptoms of depression. Several studies have shown that depression rates~     are higher in MA-using females compared to their male counterparts. It is likely that~     neurobiological and psychosocial mechanisms contribute to increased incidence of depressive~     symptoms in females.~      No clear treatment model exists to suggest how the comorbidity of depression and MA use is~     best managed. In studies of antidepressants for treatment of MA withdrawal and dependence,~     findings have suggested that antidepressants are ineffective for treating depressive~     symptoms.~      Creatine is an organic acid occurring naturally in vertebrates, where it takes part in energy~     homeostasis in tissues with fluctuating energy demands. Exogenous creatine has been shown to~     increase brain concentrations of PCr. Neuroimaging studies of creatine have shown increased~     brain phosphocreatine (PCr) content with creatine administration. Therefore, we hypothesize~     that oral creatine administration will increase PCr levels and reduce depressive symptoms in~     a sample of depressed female MA users. This hypothesis will be tested by a within subjects~     design by giving depressed MA using females oral creatine for eight weeks and measuring PCr~     pre- and post-treatment with magnetic resonance spectroscopy. Moreover, depressive symptoms~     will be measured by administration of the Hamilton Depression Rating Scale twice weekly~     during the course of creatine treatment.~   "
156736|NCT01514617|"~     It is known that volumetric response of leiomyomas following uterine artery embolization~     correlates well with patients clinical outcome. The aim of this study is to assess diffusion~     -and perfusion weighted MRI for the prediction of volumetric response following uterine~     artery embolization in patients with symptomatic leiomyomas.~   "
156737|NCT01514604|"~     Constructing a learning curve in ultrasound guided needling~      Observational study - How many attempts, with continuous training and feedback, at in-plane~     ultrasound guided needling in a phantom model are required to attain competence?~      The use of ultrasound to enable real-time needle visualisation during regional anaesthesia~     (placing local anaesthetic, via a needle, near nerves to result in numbing of an area of the~     body to be operated on) has gained in popularity in recent years. It has been recognised by~     NICE (National Institute for Clinical Excellence) and guidelines on training have been~     published, with UK equivalents pending. These call for training in the technique on models or~     'phantoms' prior to patient contact.~      It is unknown how much experience is necessary to attain competence in a phantom, prior to~     proceeding to patient contact. One study looking at experiential learning of the technique~     found a very wide range of experience needed between individuals.~      In order to study the effect of any changes in training methods on the learning of the~     technique it is necessary to have a baseline learning curve.~      The investigators are introducing a training package for anaesthetists new to the technique~     to meet the recommendations on initial phantom based training. Alongside this the~     investigators aim to gather prospective observational data allowing the investigators to~     generate a learning curve for the technique. This involves making a video recording of the~     ultrasound images of approximately 50 sequential attempts at performing a task in a phantom,~     with ongoing instruction and coaching. The whole training package will take approximately 1~     hour.~      These video clips will be reviewed and sequential attempts graded for quality of needle~     visualisation and task completion. This will allow the investigators to use a statistical~     method, Cumulative Sum (Cusum) analysis, to determine how many attempts were required to~     attain proficiency. The investigators hope to recruit approximately 20 participants to this~     pilot study, and from this determine the average amount of training necessary to attain~     proficiency. Using Cusum analysis requires the use of an acceptable failure rate, usually~     chosen arbitrarily. To add greater meaning to our findings the investigators will also invite~     anaesthetists experienced in the technique of in-plane ultrasound guided needling to~     participate. By measuring the actual success rate of our local trainers the investigators~     will be able to make a meaningful comparison of the training required to achieve a similar~     level of success.~   "
156738|NCT01514591|"~     The purpose of the study is to assess the coagulation changes that occur in laboring patients~     undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We~     will compare coagulation data to assess potential coagulation changes associated with~     hemoglobin changes before and after surgery, and related to estimated blood loss.~   "
156739|NCT01514578|"~     This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception~     and sedation in healthy adult males.~   "
156740|NCT01514565|"~     This is a prospective observational study aimed to validate biomarkers that predict response.~   "
156741|NCT01514552|"~     In areas of the world where populations are undernourished poor oral health is prevalent.~     Diets rich in fruit and vegetables are thought to have many health benefits including~     reducing the risk of oral cancer or gum disease. In particular fruits such as strawberries~     contain many different compounds which may be responsible for these proposed health benefits.~      From this study, the researchers hope to gain information about how the tissues in the mouth~     absorb strawberry gummies in a population of habitually smoking and never smoking men and~     women. The researchers will measure inflammation hormones in your saliva and urine and the~     genes in your mouth and blood. Two different strawberry gummies will be tested in this study.~     The strawberry gummies were developed at OSU in the Department of Food Science and~     Technology. One type of strawberry gummy will contain freeze-dried whole strawberries while~     the other type will have no fruit. In total the eight pieces of strawberry gummies that you~     will consume in one day will be at most equal to 1 cup of whole strawberries. The research~     team believes the two strawberry gummies may be digested and absorbed differently and that~     components in the strawberry gummies may be helpful for oral health.~   "
156742|NCT01514539|"~     Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies~     suggest that childbearing is an important contributor to the development of obesity in many~     women and that breastfeeding may be protective.~      Ghrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy~     homeostasis and are biological neuroendocrine signals that potentially affect body weight and~     adiposity/~   "
156743|NCT01514526|"~     -  Design: non-randomized, open label, phase II clinical trial.~        -  Study population and disease: adult patients with metastatic or locally advanced~          non-resectable adrenocortical carcinoma, confirmed histologically.~        -  Estimated number of patients: 15.~        -  Study drug: dovitinib (TKI-258), dosed on a flat scale of 500mg/day on a 5 days on / 2~          days off.~        -  Treatment duration: study treatment period will be continued until disease progression,~          unacceptable toxicity, death or premature withdrawal from study. An average of 6 months~          treatment period is expected.~        -  Study duration: expected recruitment period will be 18 months, and patients will be~          followed for 6 additional months after last patient is included in the trial.Study total~          expected duration is 24 months.~        -  Sites: the study is planned to be conducted in 7 Spanish centers.~   "
156744|NCT01514513|"~     The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in~     eradicating head lice as compared to Nix, both are available over-the-counter lice~     treatments.~   "
196887|NCT00986193|"~     This study is a randomised comparison of apical stent valve treatment versus conventional~     valve surgery in patients with severe aortic valve stenosis.~   "
156747|NCT01514461|"~     The purpose of this study is to determine whether LCQ908 is effective and safe in lowering~     triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia~     [HLP] type I). Data from this study will be used to support a registration submission of~     LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).~   "
156748|NCT01514448|"~     Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with~     sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was~     evaluated in these patients.~   "
156749|NCT01514435|"~     There exist already a few studies that have measured changes of brain metabolism pre and post~     Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were all~     performed in a small number of patients and used different methodologies. It is therefore not~     surprising that these investigations provided inconsistent results, as reviewed previously~     {{23 Schmidt,E.Z. 2008}}.~      In patients with treatment-refractory major depressive episodes, the investigators here~     therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur~     after treatment with ECT and (b) whether these correlate with the clinical amelioration of~     symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive~     function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and at~     the end of treatment.~      Patients with a treatment refractory depression - defined as absent clinical improvement of~     depressive symptoms after at least two trials with antidepressants from different~     pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30~     Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively~     asked for participation in this study. Patients had to be between 18 and 80 years old and to~     be physically healthy.~   "
156750|NCT01514422|"~     The purpose of this study is to evaluate minocycline as a potential treatment for bipolar~     depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is~     approved for the treatment of infections and acne. Participation in this research study is~     expected to last 8 weeks, and includes five outpatient visits.~   "
156751|NCT01514409|"~     5-hydroxytryptophan (5-HTP) is a nutritional supplement sold in many health food stores, and~     is taken in order to raise levels of serotonin in the brain. Serotonin is a neurotransmitter~     that is involved in the regulation of mood.~      Previous research has assessed the effects of raising serotonin levels using tryptophan (the~     precursor of 5-HTP) and serotonergic antidepressants on emotional processing in healthy~     volunteers. However, to date there has been no human trial investigating the effects of 5-HTP~     on emotional processing in healthy volunteers.~      Thus, the current study aims to assess the effects of 5-HTP, on emotional processing and mood~     in healthy volunteers.~   "
156752|NCT01514396|"~     The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™~     Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure~     of the topical skin in children presenting in the Emergency Department (ED).~   "
156753|NCT01514383|"~     The purpose of this study is to evaluate how surgical adhesive is used.~   "
156754|NCT01514370|"~     This is a prospective, monocentric, double blind, placebo controlled, two arm study.~      Curcumin is derived from the rhizomes of the plant Curcuma longa (common name, turmeric)~     belonging to the Zingiberaceae family found in South Asian countries, especially India which~     is the largest producer. BCM95 (bioCurcumin) is a combination of a Curcumin extract and oil~     to enhance the bio-absorbability in humans. BCM95 may enhance and prolong the antioxidant and~     anti-inflammatory effects of the standard therapy maintaining a good safety profile.~   "
156755|NCT01514357|"~     Hypothesis: If the use of B-type natriuretic peptide (BNP) is proven to be effective in~     controlling high blood pressure, it may lead to a reduction of standard therapy and improved~     cardiovascular and kidney protection.~   "
156756|NCT01514344|"~     Phase II, monocentric, open label study to assess safety and activity of intralesional~     Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.~   "
156757|NCT01514331|"~     The main purpose of this study is to investigate effects of SIMV+VG (synchronized~     intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support~     ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation~     synchrony, ventilation parameters and inflammatory mediators in neonates.~   "
156758|NCT01514318|"~     The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data~     on patients who received the Revelation Hip Stem prior to 2002.~   "
156759|NCT01514305|"~     The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System~     when used as an adjuvant to blood glucose testing.~      Device performance will be primarily evaluated in terms of the proportion of glucose values~     within a pre-specified range compared to reference values.~      Safety data of the G4 System will also be collected vis-a-vis adverse event reporting~     characterized by the incidence and severity of Serious Adverse Device Events, and Adverse~     Device Events experienced by study participants.~   "
156760|NCT01514292|"~     The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System~     when used as an adjuvant to blood glucose testing over a 7-day period in people >18 years-old~     with diabetes mellitus.~      The primary objective is to characterize the System performance with respect to laboratory~     reference venous sample measurements. The device performance will be primarily evaluated in~     terms of point and rate accuracy of the G4 System in reference to YSI.~      Safety of the G4 System will be characterized by Adverse Device Effects and Serious Adverse~     Device Effects experienced by study participants.~   "
156773|NCT01514123|"~     This is a non-randomized, multi-dose, first-in-human, multicenter, two arm (Arm A: VGX-100~     alone; Arm B: VGX-100 co-administered with bevacizumab), open label, dose escalation study in~     subjects with advanced or metastatic solid tumors. The study is aimed at evaluating the~     safety and establishing the recommended dose of the VEGF-C human monoclonal antibody VGX-100~     when administered alone or in combination with bevacizumab.~   "
156774|NCT01514110|"~     The purpose of this study is to determine dose limiting toxicities (DLT) and maximum~     tolerated dose (MTD) of RAD001, as well as to assess tumor response and overall survival.~   "
156819|NCT01513486|"~     In the present study, the effects of 5 days of lower limb immobilization with or without~     daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics~     will be determined.~   "
156761|NCT01514279|"~     The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health~     (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood~     Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case~     Western Reserve/Cleveland's project is entitled Targeting Obesity and Blood Pressure in~     Urban Youth. The site name is IMPACT (Ideas Moving Parents and Adolescents to Change~     Together).~      The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight~     and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a~     systems improvement intervention (SystemsChange), and an education-only intervention~     (Tools4Change). In addition the study assesses the potential additional impact of a~     school-community based intervention on outcomes.~      The project has two phases: a formative phase (including focus groups and a pilot) and the~     main trial. The main trial will take place over approximately four years.~   "
156762|NCT01514266|"~     Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and~     health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason~     for deterioration of lung function in COPD. Currently there is no medication available that~     can modify or reduce this inflammation. Furthermore, from literature review it has been shown~     that chronic inflammation can result in cancerous changes.~      Curcumin is a food additive used for centuries. Several studies showed that curcumin suppress~     the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down~     regulated by this substance. This study was designed to evaluate effect of combination of~     curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized~     pilot study.~   "
156763|NCT01514253|"~     Glucose has analgesic and calming effects in newborns. To date, it is not known whether the~     beneficial effects extend to care giving procedures that are performed after painful~     procedures. The investigators objective is to determine the effect of glucose 25% analgesia~     in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a~     subsequent care giving procedure.~   "
156764|NCT01514240|"~     The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily~     compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's~     disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of~     180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after~     8-week treatment defined by a CDAI score of ≤ 150.~   "
156765|NCT01514227|"~     NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet~     Therapy (DAPT) following Nobori stent deployment.~   "
156766|NCT01514214|"~     Strictures in the bile duct cause a blockage of flow of bile. This leads to potential~     problems including jaundice, itch and infection in the bile duct. The usual first step in~     this situation would be to allow flow of bile by placing a stent across the stricture. This~     is usually done by a special type of endoscopy procedure called an endoscopic retrograde~     cholangiopancreatography, or ERCP.~      The most commonly used stent are made from a plastic material called polyethylene and has a~     central lumen in which bile drains through it. Health Canada has approved the sale and use of~     another stent with a winged perimeter (the VIADUCT stent) for placement in bile duct~     strictures and is used routinely in our hospitals. However, the investigators do not know~     which stent is better at treating bile duct strictures. In order to determine which stent~     would be more useful, the VIADUCT stent and the usual polyethylene flanged stent must be~     studied under carefully controlled circumstances. This will be done by a randomized,~     subject-blinded study. Other trials in the past have looked at other stents in this way, but~     this is the first time the VIADUCT stent has been looked at in this manner. The investigators~     suspect that the design of the VIADUCT stent will allow it to work for a longer period of~     time compared to the traditional polyethylene stent.~   "
156767|NCT01514201|"~     This phase I/II trial studies the side effects and the best dose of veliparib when given~     together with radiation therapy and temozolomide and to see how well they work in treating~     younger patients newly diagnosed with diffuse pontine gliomas. Veliparib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses~     high-energy x rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide,~     work in different ways to stop the growth of tumor cells either by killing the cells or by~     stopping them from dividing. Giving veliparib with radiation therapy and temozolomide may~     kill more tumor cells.~   "
156768|NCT01514188|"~     This is a phase 2b, randomized, open-label, prospective, multicenter study comparing~     treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or~     unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy~     except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor~     recurrence has occurred for at least 12 months.~   "
156769|NCT01514175|"~     The primary objective of this study is to compare the efficacy of a single dose of~     intravenous ibuprofen compared to a single dose of ketorolac for the treatment of~     postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).~   "
156770|NCT01514162|"~     To further evaluate the long term clinical safety and effectiveness of the Trifecta valve~   "
156771|NCT01514149|"~     DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly~     injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.~   "
156772|NCT01514136|"~     Coloplast A/S has developed a new ostomy device in 8 versions.~      The primary objective of this investigation is to assess and compare the degree of leakage~     when using the 8 different devices.~      The secondary objective is to investigate several performance and safety parameters of the~     various devices.~      The aim of the primary and secondary objectives is to acquire more knowledge about the~     performance of the newly developed device and inspiration for their further development, if~     needed.~      Given that the investigation is exploratory, pass/fail criteria are not relevant. The~     investigation result will provide knowledge useful for continued decision-making/device~     development.~      The investigation is designed as a non-blinded, controlled, exploratory investigation that~     includes a total of 30-40 Danish ileostomy users.~      Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each~     device will be tested for 7 (± 2) days.~   "
156790|NCT01513902|"~     Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than~     18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).~   "
156775|NCT01514097|"~     Pain is a common cause for children seeking care in the Emergency Department (ED). Children~     with orthopedic injuries often require pain control when seeking emergency care. Despite the~     high prevalence of ED visits requiring pain control, pain is often poorly assessed and~     treated in ED settings. Currently, no standard of care exists for the management of this~     fracture-related pain in children discharged from the ED. Furthermore, discrepancies in~     analgesia administration to patients of various racial groups seeking emergency care have~     been documented but are poorly understood. No research currently exists comparing pain~     severity between upper extremity fractures requiring simple splinting to those treated with~     sedated reduction and splinting. Furthermore, there is no research regarding the prevalence~     of significant post-discharge pain nor the differences among ethnic and age groups treated in~     the ED.~      Research Questions:~      What is the prevalence of significant post-discharge pain in children treated for upper~     extremity fractures?~      Is there a difference in severity between those children requiring reduction versus simple~     splinting?~      Is there a difference in pain severity noted among different ethnic or age groups?~      Design This is a prospective, un-blinded, observational study that will include patients~     seeking treatment for an upper extremity fracture.~   "
156776|NCT01514084|"~     Facial lacerations are commonly treated in the emergency department. The nature of the injury~     leads to a great deal of concern about the long-term cosmetic appearance of the wounds.~      Research Questions~        1. What is the association between wound characteristics, wound management in the ED,~          patient satisfaction in the ED, and patient-rated cosmetic appearance of sutured wounds?~        2. Is there a difference noted among ED providers with different levels of training?~        3. Is there an association between initial satisfaction scores and wound outcome?~        4. Is there an association between short term and long term wound scores?~      Design This is a non-randomized, prospective, observational study of patients who present to~     the ED seeking treatment for facial laceration repair.~   "
156777|NCT01514071|"~     It is difficult for Pediatric Emergency Department providers to recognize clinically~     significant head injuries that are likely to require neurosurgical intervention or close~     monitoring from those that can be safely discharged.~      Research Question How do a combination of education and an animated picture depicting the~     PECARN CT Head Injury rules impact compliance to these rules and reduce unnecessary head CT~     scans?~      Design This is a within subject, repeated measures study design.~   "
156778|NCT01514058|"~     Patients who present with obstructive jaundice due to a malignant stricture often undergo a~     battery of tests for diagnosis, treatment options, and prognosis. An endoscopic retrograde~     cholangiopancreatography (ERCP) is often performed with biliary stent placement for symptom~     relief as well as brushings for cytology. An endoscopic ultrasound is performed as well for~     fine needle aspiration (FNA) of the pancreas to aid in diagnosis. However, since EUS is not~     available at many centers, patients often undergo an initial ERCP procedure with stent~     placement (which is more widely available) prior to referral for EUS. It has been reported~     that biliary stents can disturb EUS visualization due to inflammation, acoustic shadowing,~     and pneumobilia which may lessen the accuracy of diagnosis.1 The cytological yield from the~     EUS with FNA procedure may also be compromised in patients with biliary stents. As such,~     diagnosis and treatment options may be delayed. One retrospective study of 65 subjects showed~     a significant difference in the number of correctly staged pancreatic head cancers (mainly T~     stage) in patients without stents versus those with biliary stents (85% vs 47%).2 A second~     retrospective study concluded that tissue diagnosis is not influenced in patients with stents~     placed greater than 24 hours before the EUS; however, patients with stents placed just prior~     to the EUS (less than 24 hours) were more likely to have indeterminate results.1 Although the~     findings are suggestive, the studies are limited by their retrospective design and these~     questions have not yet been addressed in a prospective study.~      Both procedures require anesthesia, and when performed sequentially in the same setting, the~     duration of anesthesia is prolonged. This is concerning for the patient since complications~     may theoretically increase with prolonged anesthesia. However, a retrospective review at a~     tertiary referral center showed that combined EUS and ERCP yielded a complication rate no~     higher than that of the component procedures.3~      At our institution, the current practice is to sequentially perform both EUS and ERCP in the~     same setting for patients with suspected malignant biliary obstruction. Typically, EUS-FNA is~     performed first, followed by ERCP.~      Hypothesis We hypothesize that performing ERCP with biliary stenting immediately prior to~     EUS-FNA will decrease the diagnostic yield of EUS-FNA and diminish the ability of EUS to~     accurately stage pancreas tumors. Conversely, performing EUS-FNA prior to ERCP will increase~     biliary cannulation time and increase success rate.~      The objectives of this study are as follows:~        1. Determine the diagnostic yield of EUS-FNA (for diagnosis of cancer vs benign process)~          when performed either immediately before or after ERCP with biliary stenting (primary~          outcome)~        2. Determine the ability of EUS to accurately stage pancreatic masses (T and N staging)~          when performed either immediately before or after ERCP with biliary stenting (secondary~          outcome) in comparison to the gold standard of surgical pathology post resection or in~          comparison to CT findings (in those patients who are not surgical candidates)~        3. Determine the biliary cannulation time (the time it takes to successfully pass a wire~          into the common bile duct from the start of the procedure) and success rate of placing a~          biliary stent during ERCP when performed either immediately before or after EUS-FNA~          (secondary outcome)~   "
156779|NCT01514045|"~     The Gastric Cancer Registry will combine data acquired directly from patients with gastric~     cancer; with a family history of gastric cancer in a first or second degree relative; or~     persons with a known germline mutation in their CDH1 (E-Cadherin) gene via an online~     questionnaire with genomic data obtained from saliva, blood and tissue samples. The purpose~     of this registry is to gain better understanding of the causes of gastric cancer, both~     environmental and genetic; whether certain genomic data can predict outcomes of treatment and~     survival.~   "
156780|NCT01514032|"~     The purpose of this study is to compare two established modalities for the treatment of~     kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with~     stone-extraction). Comparison of the stone-free rates 3month postoperative.~        -  Trial with surgical intervention~   "
156781|NCT01514019|"~     An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the~     effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and~     pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers~   "
156782|NCT01514006|"~     The purpose of this study is to evaluate the possible association between postoperative~     anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.~      The investigators hypothesise that patients with a higher degree of postoperative anaemia~     have impaired postoperative rehabilitation as measured by standardized functional outcome~     tests.~   "
156783|NCT01513993|"~     The purpose of this study is to evaluate whether telemonitoring of patients with chronic~     heart failure produces a reduction in the combined end point of all cause mortality and~     number of hospitalisations, and whether it improves health related quality of life. In~     addition, the trials evaluate the economic and organisational impact of the telemonitoring~     service and examine its acceptability by patients and health professionals.~   "
156784|NCT01513980|"~     The purpose of this study is to evaluate whether the introduction of large-scale~     telemonitoring of patients with COPD produces benefits in terms of improved health-related~     quality of life and reduced access to hospital facilities. In addition, the trial evaluates~     the economic and organisational impact of the new services, and examine their acceptability~     by patients and health professionals.~   "
156785|NCT01513967|"~     This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to~     investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The study~     will be divided into three parts: A, B, and C~   "
156786|NCT01513954|"~     The purpose of this study is to determine whether progesterone hormone levels differ~     following egg retrieval with a single lumen needle compared with a double lumen needle. These~     levels will be measured on several days before and after egg retrieval. The progesterone~     levels in each IVF group will also be compared to the group of women who are having IUI. In~     addition, these progesterone levels will be correlated with pregnancy outcomes.~   "
156787|NCT01513941|"~     The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given~     with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of~     hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human~     immunodeficiency virus (HIV-1).~   "
156788|NCT01513928|"~     This study is designed to compare the pharmacokinetics of three different formulations of~     Pf-04937319~   "
156789|NCT01513915|"~     The fact that Cognitive Behavioral Therapy (CBT) is a well known efficacious intervention for~     children with anxiety disorders (AD) is undeniable. However, most children with AD have~     limited access to CBT. There is some controversial evidence on group CBT in AD involving~     families in treatment of their children and a published article on efficacy of a parent only~     group CBT for these children. Considering these data, the investigators hypothesized that~     teaching anxiety-fighting skills to parents of children with AD would diminish anxiety~     symptoms of both parents and children and improve family relational functioning.~   "
196888|NCT00986180|"~     Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the~     treatment of acute low back pain.~   "
156794|NCT01513824|"~     The purpose of the study is to examine if bio feedback guided stress management by daily~     measurement of pressure pain sensitivity followed by acupressure reduces signs of depression~     and number clinical stress signs and increases quality of life in patients with stable,~     ischemic heart disease~   "
156795|NCT01513811|"~     Bowel preparation is a major determinant of colonoscopy and colorectal surgery. Polyethylene~     glycol electrolyte solutions (PEG-E) are the most commonly used laxatives in China. However,~     a significant number of patients, especially those constipated patients, failed colonoscopies~     due to poor bowel cleaning. Inadequate preparation may also lead to missed colonic lesions.~     The study is based on the hypothesis: itopride hydrochloride, a prokinetic agent, its dual~     role as dopamine D2 receptor antagonism and acetylcho-linesterase inhibition make it an~     appropriate adjuvant for bowel preparation. It was reported to promote colonic peristalsis,~     shorten colonic transit time and accelerate propulsion of colonic luminal contents through~     inhibition of M3 receptor and dopamine D2 receptors in vitro and in vivo. So this study is to~     determine the efficacy, tolerance and safety of high dose of itopride, when given in~     different times before administration of PEG-E, for colonic preparation in patients with~     chronic constipation.~   "
156796|NCT01513798|"~     The investigators investigate if combined progressive aerobic training and resistance~     training improve metabolic control and fat mass in patients with type 2 diabetes who are~     eating a modified paleolithic diet. The investigators randomize 40 participants to two~     groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2)~     Modified paleolithic diet and general advice about exercise.~      The investigators primary hypothesis is that in patients with type 2 diabetes decreases fat~     mass more with progressive exercise under observation and a modified paleolithic diet than~     with general advice about exercise and a modified paleolithic diet.~   "
156797|NCT01513785|"~     The efficacy of traditional triple therapy has been decreased to such an unacceptable level~     as 70% in many areas. The study is based on the hypothesis: the most important factors which~     influence the effect of Helicobacter pylori (H. pylori) eradication included acid suppression~     intensity and sensitivity of antibiotics. So the investigators chose dual therapy because it~     is simple and verified to be useful. Rabeprazole, as a new proton pump inhibitor (PPI), is~     reported to be less susceptible to the influence of genetic polymorphisms for CYP2C19. So it~     has a greater and faster acid suppression effect compared to other PPIs. Amoxicillin is one~     of effective antibiotics to H. pylori with few side effects. The antibiotic resistance of~     Amoxicillin is no more than 3% in China. The purpose of our trial is to evaluate and compare~     the efficacy and safety of dual therapy regimens with different doses of Rabeprazole for~     initial treatment of H. pylori infection.~   "
156798|NCT01513772|"~     The investigators examined the effect of dexmedetomidine on the emergence agitation and~     postoperative quality of recovery in nasal surgery~   "
156799|NCT01513759|"~     The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used~     in conjunction with recombinant t-PA as a treatment for acute pulmonary embolism (PE) will~     decrease the ratio of RV to LV diameter within 48 ± 6 hours in patients with massive or~     submassive PE.~   "
156800|NCT01513746|"~     The purpose of the study is to investigate how people with type 1 diabetes experience and~     manage their diabetes, eating, and weight. Summary of the Study: If you choose to~     participate, you will complete a set of questionnaires and a structured interview. You will~     then wear a continuous glucose monitor and use your cell phone to answer study questions for~     a period of 3 days. The questions come in the form of regular phone calls between the hours~     of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete. You will also~     be asked to call in and answer study questions at other times during the day, especially~     after eating. The study involves a minimum of 2 clinic visits to Duke. Participants who live~     greater than 1.5 hours from Duke can be approved to take part in the study by phone/Skype.~     Participants will receive and return study materials through the mail.~   "
156801|NCT01513733|"~     The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel~     is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies,~     cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes~     the backbone upon which to improve upon. Thus, the primary objective of this study is to~     determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone~     based on safety and tolerability in men with chemorefractory metastatic castration-resistant~     prostate cancer (CRPC).~   "
156802|NCT01513720|"~     This is an single dose,two-way, crossover, oral bioequivalence study.~   "
156803|NCT01513707|"~     This is a prospective, multicenter, comparative, parallel-group, observational study. There~     will be 2 cohorts according to pre-transplant dialysis modality (hemodialysis or peritoneal~     dialysis). In each cohort, subjects will be observed for 12 months. Approximately, 1040~     subjects will be enrolled from 8 transplant centers.~      Subjects will be enrolled consecutively until the number of subjects in peritoneal dialysis~     group has been 260. It will take 2 years. In this period, the number of subject in~     hemodialysis group enrolled in this study will be 780. After finishing the observation of all~     subjects, to balance clinical and demographic baseline characteristics between the two~     groups, subjects will be selected in each cohort with 1:1 matched using propensity score~     method. And then primary and secondary endpoints will be compared between two groups.~   "
156804|NCT01513694|"~     The purpose of this trial is to test the effectiveness of the use of a new therapeutic~     strategy in treating patients with degenerative disc disease lumbar intervertebral fusion~     with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium~     phosphate ceramic (Conduit TM).~   "
156805|NCT01513681|"~     This is an single dose,two-way, crossover, oral bioequivalence study.~   "
156806|NCT01513668|"~     The purpose of this study is to compare single-dose oral bioavailability of acetaminophen 650~     mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories, USA~     (subsidiary of Ranbaxy) with Tylenol extended release geltabs (containing acetaminophen 650~     mg) of Mc Neil, Consumer & Specialty Pharmaceuticals, U.S.A in healthy, adult, male human~     subjects under fed condition.~   "
156820|NCT01513473|"~     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).~      The aim of this trial is to investigate the efficacy and safety of insulin degludec in~     children and adolescents with type 1 diabetes mellitus.~   "
156807|NCT01513655|"~     Background: In chronic obstructive pulmonary disease, the prognosis for patients who have~     survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor.~     Despite being shown to improve survival and quality-of-life in stable patients with chronic~     hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in~     unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory~     failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic~     respiratory failure, treated with noninvasive ventilation, we have been able to reduce~     mortality and the number of repeat respiratory failure and readmissions by continuing the~     acute noninvasive ventilatory therapy as a long-term therapy.~      Methods: Multi-center open label randomized controlled trial of 150 patients having survived~     an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure~     due chronic obstructive pulmonary disease. The included patients are randomized to usual care~     or to continuing the acute noninvasive ventilation as a long-term therapy, both with a~     one-year follow-up period.~      End points: The primary endpoint is one-year mortality; secondary endpoints are time to death~     or repeat acute hypercapnic respiratory failure, number of readmissions and repeat acute~     hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep quality, lung~     function, and arterial gases.~   "
156808|NCT01513642|"~     Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac~     surgery patients, the breath-stacking technique has been proposed as an alternative to~     increase pulmonary volumes in the post-operative period.~      Objective: To compare inspiratory volume and electromyographic activity of respiratory~     muscles during breath stacking technique and incentive spirometry in patients undergoing~     cardiac surgery.~   "
156809|NCT01513629|"~     Autism spectrum disorders (ASD) is a highly hereditary neuropsychiatric disorder. In children~     and adolescents worldwide, the prevalence of ASD is estimated at 0.6%. Understanding the~     biological mechanism of this disorder could potentially facilitate prompt, accurate and~     personalized therapy. The dysfunction of fronto-temporal circuitry may explain language~     impairment in ASD. In addition, pieces of evidence suggest that the abnormality of the~     cortico-striato-thalamic circuitry might be related to social deficits. However, very little~     is known how changes in these two circuitries are related to variation in genotypes. Previous~     reports on ASD using magnetic resonance imaging (MRI) have demonstrated alteration of brain~     structure. Recent advance in neuroimaging has shown that structural connectivity of a~     specific circuitry is superior to regional analysis in terms of higher penetrance of genetic~     effects and better account for behavioral variance. Therefore, it is plausible that~     connectivity imaging may serve as effective endophenotypes that link clinical manifestation~     (phenotypes) and the biological variables (genotypes). In the past five years, our lab has~     established world leading diffusion spectrum imaging techniques, and applied the techniques~     to clinical studies on ASD, schizophrenia, stroke and epilepsy. The clinical experience and~     technical strengths provide a strong basis for us to extend to imaging genetics, aiming to~     determine effective endophenotypes of ASD. Therefore, the goal of this project is to validate~     structural connectivity of fronto-temporal and cortico-striato-thalamic circuitries as~     effective imaging endophenotypes of ASD. Specifically, the investigators will achieve the~     goal through a series of validation. First, the investigators will demonstrate that~     structural connectivities in the two targeted circuitries are indeed different among groups~     of patients with ASD, unaffected siblings, and neurotypicals. Second, the investigators will~     demonstrate in neurotypicals and unaffected siblings that the altered structural~     connectivities related to social and language impairments are indeed different in carriers of~     risk genes, i.e. CNTNAP2 and SLC25A12, respectively. Last, the investigators will demonstrate~     in all participants that the altered structural connectivities are associated with the~     corresponding behavioral variances in social and language function. This two-year project is~     a cohort study consisting of three groups, namely patient, unaffected siblings, and control~     groups matched in age, gender and handedness. The patient and sibling groups consist of 20~     boys each, age 10-15 years old, and the control group consists of 40 boys. The examination~     includes behavior assessment (IQ test, neuropsychological and clinical assessment), MRI study~     (structure MRI and diffusion spectrum imaging for structural connectivity) and genome~     scan(specifically candidate genes related to language function, i.e. SLC25A12, and to social~     function, i.e. CNTNAP2). In conclusion, this is the first cohort project on imaging genetics~     in Taiwan. The success of this project will facilitate the progress of translational~     neuroscience in Taiwan. The methodology of validating endophenotype will be readily extended~     to other psychiatric diseases.~   "
156810|NCT01513616|"~     Dyspnea (respiratory discomfort) and activity limitation are the most common symptoms of~     chronic obstructive pulmonary disease (COPD) and contribute importantly to a perceived poor~     quality of life. Recent international guidelines have stressed the importance of dyspnea~     alleviation and improvement exercise tolerance as a means of enhancing quality of life and~     other long term outcomes in this population. Modern pharmacotherapy is the first step in~     symptom management but the overall impact of bronchodilator therapy is relatively small.~     Exercise training remains the most effective treatment for ameliorating dyspnea and improving~     exercise endurance and was the main focus of this study.~      The main objectives of the study were:~        1. To conduct and compare detailed studies of respiratory mechanics during cycle exercise~          before and after exercise training (EXT) compared with an untrained control group. By~          multiple regression analysis, the investigators will establish the main contributors to~          dyspnea relief after EXT.~        2. To compare the magnitude of change in endurance during constant work rate cycle exercise~          with those measured during walk tests and the endurance shuttle walk test after EXT~          relative to control. To evaluate which test (constant work rate cycle, six-minute walk~          test, or endurance shuttle walk test) is the most sensitive test for measuring changes~          in endurance after EXT versus control.~        3. To compare the change in standardized dyspnea ratings (Borg Scale) during constant-load~          cycling with a variety of other activity-related dyspnea questionnaires. To evaluate~          which of these measurements is the most sensitive for examining changes in perceived~          discomfort during exercise.~        4. To evaluate the contribution of psychological factors (anxiety, fear, respiratory panic,~          self-efficacy) to the perceived improvement of symptoms following EXT. The investigators~          will use multiple regression analysis to examine associations between changes in~          perceived dyspnea and changes in anxiety and self-efficacy measured by validated~          questionnaires and Borg intensity ratings?~   "
156811|NCT01513603|"~     CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents~     is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the~     efficacy of the regimen in patients with relapsed ALL.~   "
156812|NCT01513590|"~     This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the~     efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart~     30) in insulin naïve subjects with type 2 diabetes.~   "
156813|NCT01513577|"~     Convalescence after lumbar surgery is dependent on the extensiveness of the surgical~     procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve~     excellent clinical results with less pain, morbidity and disability.~   "
156814|NCT01513564|"~     Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery~     accelerated stay programs with optimized pain management enhance recovery.~      The objective is to evaluate the effect of a revised and optimized perioperative fast track~     program in lumbar fusion surgery.~   "
156815|NCT01513551|"~     The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia~     disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal~     Polysaccharide Vaccine (Pneumovax 23) and 13-valent Pneumococcal Conjugate Vaccine (Prevnar~     13) when administered to healthy adults 50 years of age or older.~   "
156816|NCT01513538|"~     The technological progress allowed the development of more and more sophisticated pacemakers,~     widening the therapeutic indications but also meeting the physiological needs of the patient.~     This progress led to a more and more complex programming for the physicians. To help them set~     optimally the pacing parameters, physicians refer to the existing recommendations of learned~     societies as well as to his expertise. Manufacturers developed also algorithms integrated~     into pacemakers with the aim of assisting physicians in their programming.~      TherapyGuide is a function which proposes a programming adapted to the psychopathological~     state of the patient, with a justification based on experts' consensus, clinical studies as~     well as on published articles.~      Physicians have the choice to accept or reject the programming proposed by TherapyGuide. When~     rejected, there is no means to analyze the modifications brought to the proposed set of~     parameters. The nature, the frequency and the reasons of these modifications are not thus~     known.~      The purpose of this study is to assess the acceptance of the TherapyGuide proposals by~     physicians and to identify the most frequent type of programming changes they make and their~     rationale.~   "
156817|NCT01513525|"~     This trial is conducted in Europe. the aim of this trial is to compare the pharmacokinetic~     profile of liraglutide between administrations in the thigh versus the abdomen and between~     administrations in the upper arm versus the abdomen.~   "
156818|NCT01513499|"~     Exciting advances have led to the concept that hormones can modulate appetite and food~     intake. Oxytocin is a peptide hormone that is released in regions throughout the brain,~     including areas involved in food motivation. Animal studies suggest that oxytocin may reduce~     food intake. The effects of oxytocin administration on eating behavior in humans, which could~     have important implications in eating-related disorders ranging from obesity to anorexia~     nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of~     single-dose oxytocin administration investigates whether:~        1. Caloric intake will decrease following administration of oxytocin versus placebo~        2. Appetite will decrease following administration of oxytocin versus placebo~        3. Resting energy expenditure will increase following administration of oxytocin versus~          placebo~   "
156822|NCT01513447|"~     For most women, the most significant pain they will experience is the pain associated with~     childbirth. Up to one-third of women experience back labor, this typically occurs when the~     fetus assumes varying degrees of malposition, especially the occiput posterior position, and~     causes additional constant pressure against the maternal spine and pelvis. Back labor~     presents as constant pain, that occurs even between contractions. It is often difficult to~     manage, by the patient, the obstetrician, and the anesthesiologist, and may increase the rate~     of instrumental and caesarian delivery.~      Epidural anesthesia/analgesia is the most common and effective intervention used to help~     women cope with labor pain. Dilute concentrations of local anesthetic and opioid provide~     complete analgesia for most women. Some women, however, have breakthrough pain, often due to~     back labor, and require more concentrated drug solutions. This increases the side effects~     associated with these drugs (e.g., hypotension, pruritus, motor block), thus treatment of~     this pain poses a challenge for the anesthesiologist and the obstetrician.~      Sterile water injections (SWI) are a simple and well-established method of managing labor~     pain among midwives. This intervention was first used to alleviate pain associated with~     kidney stones, and was introduced to obstetrics in the 1970s. Using a syringe, small amounts~     of sterile water is deposited subcutaneously near the sacral area. The sterile water causes~     osmotic and mechanical irritation resulting in a brief (15-30 second) and significant~     stinging sensation. The onset of pain relief follows almost immediately and may last for up~     to two hours. The procedure can be repeated a number of times.~      Sterile water for pain management is most often administered using four intracutaneous~     injections: two sites lateral to the lumbosacral spine and two sites 2-3 cm below and 1-2 cm~     medial to the original two injection sites. 0.1 mL of sterile water is injected between the~     dermal layers to raise a small bleb on the skin surface at each of the four sites. In labor,~     the injections are administered sequentially during a uterine contraction, with the series of~     four injections, performed two at a time, completed within 20-30 seconds.~      The investigators hypothesize that the use of sterile water injections in women with~     neuraxial analgesia with breakthrough pain will result in decreased local anesthetic~     requirements and increase patient satisfaction.~   "
156823|NCT01513434|"~     The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has~     been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these~     methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study~     is not easily available nor an in vivo test. The purpose of this study is to compare the~     position of the femoral tunnel aperture on conventional MRI and the outcomes after single~     bundle ACL reconstruction using free tendon Achilles allograft between transportal technique~     and transtibial technique in active young men.~   "
156824|NCT01513421|"~     The Percutaneous drainage of symptomatic intra-abdominal collection (primary or secondary to~     surgery)is the treatment of choice in the absence of peritonitis signs. In critically ill~     patients, this procedure allows to avoid or postpone surgery. In these settings, the~     percutaneous drain can be either in Active Vacuum Pressure or in Free drainage. However, no~     prospective trials has assessed the efficiency of these two modalities of drainage in cases~     of infected intra-abdominal collections. The investigators aimed then to prospectively~     analyzed the efficiency (in term of infectious control) of drainage under active vacuum~     pressure vs. free drainage for the treatment of infected intra-abdominal collections.~   "
156825|NCT01513408|"~     Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer,~     and makes it possible to evaluate tumour response. Achieving pathological complete response~     (pCR) after chemotherapy is the most important prognostic factor for these patients. However,~     patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not~     achieve pCR is poorly documented, and no specific prognostic factors have been clearly~     identified.Preclinical and clinical studies argue for an immunogenic role of some~     chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating~     recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence~     antitumour immune response, partially contributing to efficacy. Conversely, tumours can~     promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour~     immune response, and increased numbers of regulatory T-cells are associated with less~     favourable prognosis in breast cancer patients. We have previously shown that a high number~     of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry~     on surgical specimens, is associated with better response and better survival in breast~     cancer patients, independently of whether pCR was achieved, the type of chemotherapy used,~     and the type of breast cancer. Therefore, we propose to validate in a prospective study this~     immunological prognostic marker in a large cohort of patients treated with neoadjuvant~     chemotherapy.~   "
156826|NCT01513395|"~     Focal myometrial (uterine) contractions occur in a substantial number of vaginal ultrasound~     examinations and can impede accurate cervical length measurement and placental location~     determination. The timing of bladder voiding is associated with the prevalence of focal~     myometrial contractions on vaginal ultrasound cervical assessment. We propose a blinded~     randomized-controlled trial of bladder voiding immediately before vaginal ultrasound for~     cervical assessment compared with no bladder voiding immediately before vaginal ultrasound in~     order to determine the prevalence of focal myometrial contractions during vaginal ultrasound~     cervical assessment and test whether timing of bladder voiding is associated with their~     incidence.~   "
156827|NCT01513382|"~     Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.~   "
156828|NCT01513369|"~     The purpose of this study is to investigate the correlation between HbA1c and iron status in~     Type 2 Diabetes mellitus patients with iron deficiency by intravenous substitution of iron.~   "
156829|NCT01513356|"~     BKM120 is a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K)~     inhibitor, currently under investigation in a first-in-man study in patients with advanced~     solid tumors (wild type and PIK3CA-mutated). Consistent, dose-dependent pharmacodynamic~     activity has been demonstrated and clear signs of anti-tumor activity have been seen with~     BKM120.~   "
156830|NCT01513343|"~     The goal of this study is to develop and test the efficacy of a scientifically-based,~     culturally competent seven-session parent directed, obesity prevention program focused on~     parental feeding strategies that support young children's self-regulation of intake.~   "
156831|NCT01513330|"~     The purpose of the study is to evaluate leakage of a newly developed ostomy product compared~     to standard care in subjects with colostomies. Subjects will be asked to use each test~     product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show~     that the newly developed ostomy product is significantly better to reduce leakage compared to~     standard care.~   "
156832|NCT01513317|"~     The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a~     reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic~     Syndrome (MDS).~   "
156833|NCT01513304|"~     Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence~     of parental bias in reporting crying behaviour.~   "
156834|NCT01513291|"~     The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo~     for preventing migraines in participants with episodic migraine. After a 28-day Screening~     period during which baseline number of monthly migraine days was assessed, participants were~     randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who~     completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2~     weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the~     initial randomization. In the Run-out Period, participants who received placebo in the~     Treatment Period continued to receive placebo and participants who received MK-6096 in the~     Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested~     in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as~     measured by the mean change from baseline in monthly migraine days averaged over the 12- week~     treatment period.~   "
156835|NCT01513278|"~     The standard treatment for early-stage breast cancer is breast-conserving surgery followed by~     adjuvant radiation therapy to the whole breast. This approach leads to low recurrence rates~     with a good cosmesis and provides an effective alternative to mastectomy. However, in most~     women receiving radiotherapy radiation dermatitis occur to some degree.~      Radiation dermatitis generally manifests within a few weeks after the start of radiation~     therapy. Its onset varies depending on the radiation dose intensity and the normal tissue~     sensitivity of individuals. As the cumulative dose of radiation increases the transient~     erythema occurring during the first weeks of radiotherapy may evolve into the more persistent~     erythema and to dry or even moist desquamation that reflects the damage to the basal cell~     layer and the sweat and sebaceous glands.~      There is currently no evidence that prophylactic treatments, beyond keeping the irradiated~     area clean and dry, are effective in reducing the incidence or severity of radiation~     dermatitis (Bolderston et al. 2006).~      However, together with other enzymes of the peroxidase pathway, SOD scavenges the superoxide,~     hydroxyl, and other oxygenated free radicals (Klug et al. 1972; Tainer at al. 1983). In~     physiological conditions, the production of free radicals (Monte & Sacerdote 1994) and the~     action of antiradicals' enzymes is balanced. Following tissue injuries, either pathological~     or caused by agents such as radiation therapy, an excess production of free radicals is~     observed (Petkau 1986; Lorette & Machet 2001). Furthermore, basal SOD is increased in breast~     cancer patients before radiation therapy as compared to controls (Seth et al. 2003), and~     decreases after radiotherapy (Ray at al. 2000). Hence, liposomal rhSOD applied during~     radiotherapy could be used to prevent the effects of free radicals and thus might protect the~     patient's skin from radiation-induced skin reactions.~      TREATMENT PLAN All patients receive APN201 and placebo at the same time. The irradiated~     region is divided vertically into two symmetric areas (left and right). One area is treated~     with APN201, the other area is treated with placebo in a double-blind fashion.~      Study treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and~     continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to~     a total dose of 50.0 Gy or 50.4 Gy, respectively) (see schedule of assessments, section 5.1).~      Study treatment is stopped if radiation dermatitis of ≥ grade 2 occurs in one or both treated~     areas for ≥ 3 days AND a difference in the severity of radiation dermatitis of ≥ 1 grade is~     seen between the two treated areas. From that point in time the patient only receives the~     treatment that appeared to be beneficial and this treatment is applied to the whole~     irradiated region until completion of the 25th, respectively 28th, fraction.~      Treatment stops earlier in case of progressive disease or unacceptable toxicity or~     intolerability.~   "
156836|NCT01513265|"~     The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP~     = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP =~     Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the~     drug use in elderly inpatients.~   "
156837|NCT01513252|"~     The MAPT PLUS study is a two-year extension of follow-up of the patients included in the MAPT~     preventive study, after completion of the interventions. Subjects in the four groups of the~     MAPT study will be prospectively followed. MAPT is a multicentre, randomised,~     placebo-controlled study, using a 4-group design with 3 treatment groups (omega 3 alone,~     multi-domain intervention alone, omega 3 plus multi-domain intervention, n=420 each) and a~     placebo group (n=420). The MAPT PLUS study will be an extension of the MAPT study and~     includes an annual follow-up for two years.~   "
156838|NCT01513239|"~     MK-3415A is the combination of monoclonal antibodies to Clostridium (C.) difficile toxin A~     (MK-3415) and toxin B (MK-6072). This study will investigate whether: 1) treatment with~     MK-6072 or MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease~     Clostridium Difficile Infection (CDI) recurrence compared with placebo; and 2) MK-6072 and~     MK-3415A will be generally well tolerated in participants receiving SOC therapy for CDI~     compared with placebo.~   "
156839|NCT01513226|"~     This study shows that cycled light during neonatal care reduces infant's fussing and crying~     behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.~   "
156840|NCT01513213|"~     The purpose of this study is to evaluate whether a correlation exists between the partial~     pressure of carbon dioxide existing within arterial blood and the gradient between inhaled~     and exhaled fractions of oxygen.~   "
156841|NCT01513200|"~     This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12~     healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered~     together have any significant impact on the pharmacodynamic effects of UFH and the~     pharmacokinetics of Bendavia.~   "
156842|NCT01513187|"~     Phase I / II, open, prospective, multicenter single-arm, Clinical Trial in two stages: in the~     first stage it will determine the optimal dose of the combination of pazopanib and interferon~     alfa-A2 in the treatment of patients with advanced renal carcinoma and a second stage that~     will determine the efficacy of this combination measured in terms of response rate.~   "
156843|NCT01513174|"~     This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281)~     versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation~     positive advanced non-small-cell lung cancer.~   "
156844|NCT01513161|"~     The purpose of this study is to determine whether nalfurafine hydrochloride is effective and~     safe in the treatment for conventional-treatment-resistant pruritus in patients receiving~     hemodialysis.~   "
156845|NCT01513148|"~     The introduction of light emitting diode (LED) devices as a novel treatment for pain relief~     in place of low-level laser warrants fundamental research on the effect of LED devices on one~     of the potential explanatory mechanisms: peripheral neurophysiology in vivo. A randomized~     controlled study will be conducted by measuring nerve conduction on the superficial radial~     nerve of healthy subjects (n=64). One baseline measurement and five post-irradiation~     recordings (2-min interval each) will be performed of the nerve conduction velocity (NCV) and~     peak latency (PL) and peak amplitude (PA). The experimental group (=32) will receive an~     irradiation of 2 J/cm2 with an infrared LED device (Dynatronics Solaris Model 705), while the~     placebo group will be treated by sham irradiation. The purpose of this study is to~     investigate the effects of LED light on the conduction velocity and amplitude of the~     superficial radial nerve.~   "
156846|NCT01513135|"~     Tat is a key HIV regulatory protein produced very early after infection, prior to virus~     integration, and necessary for viral gene expression, cell-to-cell virus transmission and~     disease progression. Previous studies in natural HIV infection, indicated that the presence~     of a Tat-specific immune response correlates with a lower incidence and reduced risk of~     progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune~     response to Tat may exert a protective role and control the progression to AIDS in vivo.~     Moreover, Tat is conserved in its immunogenic regions (both B and T cell) among all subtypes.~     subtypes. Recent data, in fact, indicate an effective cross-clade recognition of clade B~     strain-derived (BH-10) Tat protein from the HTLV-IIIB lab-adapted virus strain (Buttò, 2003),~     which was isolated about 30 years ago (Ratner, 1985), by sera from individuals infected with~     viruses circulating at the present in Italy and in Africa, thus reflecting the high degree of~     conservation of the corresponding Tat regions and providing strong formal evidence that a~     Tat-based vaccine may indeed be used in the different geographic areas of the world, since it~     is capable of inducing a broad immune response against different virus clades. Based on this~     rationale and on the positive results of preclinical (Cafaro, Nat Med 1999) and phase I~     preventive and therapeutic clinical trials with Tat protein (ISS P-001 and ISS T-001,~     respectively) (Ensoli AIDS 2008, Vaccine 2009; Longo Vaccine 2009; Bellino RRCT, 2009) a~     phase II therapeutic, open label, clinical study with Tat protein (ISS T-002,~     ClinicalTrials.gov NCT00751595) was sponsored by ISS and activated in 11 clinical sites in~     Italy in HIV-infected HAART-treated subjects (Ensoli F, Retrovirology 2015).In this study,~     subjects are randomized into two arms to receive 3 or 5 vaccinations monthly; each arm is~     composed of two treatment groups, receiving 7, 5 or 30 µg of Tat, respectively.Results~     obtained in 168 individuals after trial completion (48 weeks), as well as after a follow-up~     of 144 weeks for a subgroup of vaccines, indicated that Tat vaccination is safe, immunogenic~     and capable of reducing the immune dysregulation which persists despite HAART in treated~     individuals (Ensoli et al,PLoS ONE 2010). Anti-Tat Abs were induced in most patients (79%),~     with the highest frequency and durability in the Tat 30 µg groups (89%) particularly when~     given 3 times (92%) (Ensoli B.,PLoS ONE 2010; Ensoli F., Retrovirology 2015). Moreover,~     vaccination promoted a durable and significant restoration of T, B, natural killer (NK)~     cells, and CD4+ and CD8+ central memory subsets. Moreover, a significant reduction of blood~     proviral DNA was seen after week 72, particularly under PI-based regimens and with Tat 30 µg~     given 3 times (30 μg, 3x), reaching a predicted 70% decay after 3 years from vaccination with~     a half-life of 88 weeks. This decay was significantly associated with anti-Tat IgM and IgG~     Abs and neutralization of Tat-mediated entry of oligomeric Env in dendritic cells, which~     predicted HIV-1 DNA decay. Finally, the 30 μg, 3x group was the only one showing significant~     increases of NK cells and CD38+HLA-DR+/CD8+ T cells, a phenotype associated with increased~     killing activity in elite controllers (Ensoli F., Retrovirology 2015). These data indicate~     that Tat immunization represents a promising pathogenesis-driven intervention to intensify~     HAART efficacy (Ensoli et al,PLoS ONE 2010).~   "
156847|NCT01513122|"~     The use of anti HIV drugs (ART), and in particular a class of drugs known as nucleoside~     reverse transcriptase inhibitors (N(t)RTI), has been associated with changes in body fat and~     in particular loss of peripheral fat in the limbs. Low bone mineral density and osteoporosis~     are also common in HIV-infected patients. There appears to be some association between ART~     and bone loss, but this is poorly understood and requires further research. The SECOND-LINE~     study provides an opportunity to examine if a new anti-HIV drug (raltegravir) can result in~     greater increase in limb fat than a drug regimen containing N(t)RTI, which is currently~     standard of care. This study also provides an opportunity to examine if additional bone loss~     occurs with the second regimen of anti-HIV drugs and whether non-N(t)RTI regimens of ART used~     in second line therapy result in more or less bone loss than use of other classes of anti-HIV~     drugs such as protease inhibitors or N(t)RTI combinations.~      It is hypothesized that subjects randomised into Raltegravir arm will demonstrate greater~     increases in limb fat and smaller reductions in bone density at the proximal femur over 48~     weeks than those randomised into the control arm (LPV/r + 2-3N(t)RTIs).~   "
156848|NCT01513109|"~     The purpose of this study is to evaluate the safety and the efficacy of combined treatment~     strategy of WT1ASCI, infusion of ex vivo regulatory T cells depleted T lymphocytes and in~     vivo regulatory T cells depletion as post-consolidation therapy in patients with WT1-positive~     Acute Myeloid Leukemia. The study will also evaluate the clinical activity and immune~     response of this approach in bad risk patients in CR1 and all patients in CR2 or CR3, non~     eligible for an allogeneic Hematopoietic Stem Cell Transplantation~   "
159901|NCT01473108|"~     Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this~     single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in~     healthy male subjects.~   "
156849|NCT01513096|"~     In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were~     proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included~     in a few studies. The investigators study was to show that sufficient dosage of prokinetics~     added to split dose of PEG improves the state of bowel preparation.~   "
156850|NCT01513083|"~     This open-label, parallel group study will evaluate the pharmacokinetics and safety of~     trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or~     reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1~     of each 3-week cycle. Anticipated time on study treatment is until disease progression or~     unacceptable toxicity occurs.~   "
156851|NCT01513070|"~     This study investigates the effective power of angina pectoris after Quick-Acting Heart~     Reliever and isosorbide dinitrate interventing respectively the patients with moderate~     coronary stenosis for six months. At the same time, the studying will assess the plaque,~     myocardial blood-supplying,quality of life and observe the end point of the heart (including~     the myocardial revascularization, death and myocardial infarction). The purpose is to study~     the function of the blood-quickening stasis-transforming formula Quick-Acting Heart Reliever~     for moderate coronary stenosis lesions.~   "
156852|NCT01513057|"~     An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose,~     crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's~     Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in~     healthy, adult, human, male subjects under fed conditions.~   "
156853|NCT01513044|"~     An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose,~     crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's~     Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in~     healthy, adult,human, male subjects under fasting conditions.~   "
156854|NCT01513031|"~     The purpose of this study is to determine if follow-up by a pharmacist over the telephone~     improves adherence and short term clinical outcomes in the patient with atrial fibrillation~     prescribed an oral anti-arrhythmic medication. This study will also identify the reasons~     people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication~     counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a monthly~     basis to assess adherence over one year.~   "
156855|NCT01513018|"~     The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High~     tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery.~     The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal~     volumes on arterial oxygenation and Intrapulmonary shunt during OLV.~      One hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were~     randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero~     end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg~     with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute. During~     the subsequent 30 minutes, each patient received the alternative management. Minute volume~     was thus kept constant during each experimental condition. Arterial blood partial pressures,~     hemodynamic responses, and ventilatory parameters were recorded. Results are presented as~     means ± SDs; P < 0.05 was considered statistically significant.~   "
156856|NCT01513005|"~     The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve~     Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed~     as a Day-Case surgery.~   "
156857|NCT01512992|"~     The purpose of this study is to assess the effects of a complex telemedicine intervention as~     a part of an integrated care program for patients with chronic obstructive pulmonary disease~     (COPD) discharged from the hospital after disease exacerbation. Will be evaluated whether the~     intervention produces benefits in terms of mortality, reduction in hospital readmissions and~     health-related quality of life. In addition, the trial evaluates the economical and~     organizational impact of the new service and examines its acceptability by patients and~     health professionals.~   "
156858|NCT01512979|"~     The purpose of this trial is to determine whether a initial combination of linagliptin and~     metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed,~     treatment-naïve patients with Type 2 Diabetes.~   "
156859|NCT01512966|"~     This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF~     Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.~   "
156860|NCT01512953|"~     This study aims to prospectively assess whether there is an interaction between genetic~     status in terms of 2C19 activity and residual platelet reactivity after clopidogrel intake in~     patients who underwent coronary stenting for elective, urgent or emergent intervention.~   "
156861|NCT01512940|"~     Various gastric restrictive procedures have evolved over the years but abandoned due to poor~     long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic~     gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done~     as an alternative to the other restrictive procedures. But the short and long term safety and~     efficacy outcomes of LGCP is not well documented in current literature. American society of~     metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be~     considered investigational at this time and should be performed under a study protocol with~     third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to~     review adverse events and outcomes.~      The objective of this study will be to demonstrate feasibility , short term and long term~     safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding~     of stomach and thereby achieving good weight loss .~   "
156873|NCT01512784|"~     Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV~     infection and the development of HPV-associated lesions in female and male anogenital tract.~     Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in~     HIV-infected population are few. The present study is a non-randomized controlled clinical~     trial with the primary objective to determine safety ad immunogenicity of quadrivalent human~     papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young~     adults.~   "
156874|NCT01512771|"~     We hypothesize that prevention of Sleep Disordered Breathing among PTSD patients with nasal~     CPAP will result improve their anxiety, insomnia and alcohol craving (among those who use~     alcohol to control their symptoms).~   "
156862|NCT01512927|"~     The incidence and prevalence of end-stage renal disease (ESRD) in Taiwan are both the highest~     worldwide from 2001 to 2008. In Taiwan, more than 90% of the ESRD patients are hemodialysis~     patients. Either arteriovenous fistula (AVF) or arteriovenous graft (AV graft) is essential~     for the vascular access of these patients. However, frequent AVF stenosis or thrombosis~     occurs in 10-30% hemodialytic patients, and the rates are even higher, around 30-70%, in~     those who has a past history of AVF/AV graft stenosis. Therefore, early detection of AVF~     stenosis is essential in caring for these hemodialysis patients in terms of medical economics~     and psychological impact. Unfortunately, angiographic study is expensive and invasive and~     needs contrast medium injection. The diagnostic accuracy of color duplex ultrasound in AVF~     stenosis remains satisfactory, but it is not always available when decreased AVF flow or an~     acute thrombotic event occurs. Continuous AVF/ AV graft flow monitoring by patient himself is~     a better option in terms of long-term care. Previous study indicated that stethoscope~     waveform analysis could be used as an alternative to diagnosis of vascular stenosis.~     Therefore, we aim to investigate AVF/ AV graft stenosis by using the electronic stethoscope~     (3M Littmann) for AVF sound recording, followed by software analysis by using waveform~     decomposition, principle component analysis (PCA) and sequential forward selection algorithm~     [xx]. Our study results will provide a new diagnostic option, which is low cost, non-invasive~     and self-monitoring, of AVF stenosis in ESRD patients.~   "
156863|NCT01512914|"~     Studies evaluating intraperitoneal local anesthetic instillation for pain relief after~     laparoscopic procedures have provided conflicting results. This randomized, double-blind~     study was designed to assess the effects of a novel intraperitoneal local anesthetic~     administration technique using nebulization on pain relief after gynecologic laparoscopic~     surgery.~   "
156864|NCT01512901|"~     This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for~     macular edema following branch retinal vein occlusion~   "
156865|NCT01512888|"~     SCID-X1 is a genetic disorder of blood cells caused by DNA changes in a gene that is required~     for the normal development of the human immune system. The purpose of this study is to~     determine if a new method, called lentiviral gene transfer, can be used to treat SCID-X1.~     This method involves transferring a normal copy of the common gamma chain gene into the~     participant's bone marrow stem cells. The investigators want to determine if the procedure is~     safe, whether it can be done according to the methods they have developed, and whether the~     procedure will provide a normal immune system for the patient. It is hoped that this type of~     gene transfer may offer a new way to treat children with SCID-X1 that do not have a brother~     or sister who can be used as a donor for stem cell transplantation.~   "
156866|NCT01512875|"~     The objective of this study is to elucidate the role of drinking water derived from the~     public source in Lima, Peru and transmission of H. pylori infection using genotypic~     techniques.~   "
156867|NCT01512862|"~     Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a~     marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency~     is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and~     lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect~     in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of~     vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary~     hyperparathyroidism in patients with advanced chronic kidney diseases.~      Therefore, the objective of this study is to evaluate the anti-proteinuric effect of~     calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and~     placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function,~     serum and urinary inflammatory markers, and adverse event will be monitored.~   "
156868|NCT01512849|"~     The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with~     type 2 diabetes mellitus who have moderate renal impairment.~   "
156869|NCT01512836|"~     This randomized controlled trial (RCT) will examine a nurse case management model for~     patients suffering from chronic obstructive pulmonary disease (COPD) in a Danish~     municipality, and is performed in order to evaluate the use of case management as a tool in~     achieving integrated, quality and cost-effective care for this group of patients.~      The main objectives are to evaluate how case management influences on hospital admissions,~     mortality, quality of life and self care, as well as to compare costs and cost-effectiveness~     of case management vs. usual care.~   "
156870|NCT01512823|"~     This pragmatic randomised controlled trial (RCT) used a two-group parallel design with~     matched-pair stratification by type (clinician/manager) and knowledge score. The trial aimed~     to: 1) determine whether an IE was more effective than a DE for improving EBP knowledge,~     skills and use at 12 weeks, and 2) to investigate the feasibility of conducting a RCT with~     occupational therapists in a public health setting. Occupational therapists employed by the~     Western Cape Department of Health (DOH) form,ed the study population(N=98). Fifty-eight~     consented to participate and were randomly allocated to either an interactive (IE) or a~     didactic (DE) educational intervention using coin tossing. Data was collected at baseline and~     12 weeks The primary outcome was increased EBP knowledge at 12 weeks shown by an improved~     total knowledge score. Secondary outcomes were improved attitudes and behaviour. Data were~     collected at the health facilities where participants were employed. Raters for the audit~     were blinded but participants and the provider could not be blinded.~      Thirty participants were allocated to receive the IE and 28 the DE. Twenty-five participants~     in the IE and 21 in the DE completed the trial and were included in the 12 week analysis.~     Results revealed no significant difference between the groups in the primary knowledge~     outcome at 12 weeks. Examination of within-group changes revealed significant improvements in~     knowledge in both groups (IE: T=4.0, p<0.001; DE: T=12.0, p=0.002), but the IE also showed a~     significant increase in behaviour (T=64.5, p=0.044) and attitudes on one sub-scale (T=33.0,~     p=0.039). As the study was powered at 43%, it may have failed to detect significant~     differences at 12 weeks. Conducting a high-quality RCT was feasible and the risk of bias was~     assessed as low. The OTEBP trial adds strength to the existing evidence that both didactic~     and interactive educational interventions can improve knowledge, but it seems that~     interactive interventions may be more effective for changing behaviour. High-quality~     pragmatic trials can feasibly be conducted within the public health service~   "
156871|NCT01512810|"~     Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical~     staging for endometrial cancer increases operative time and surgical morbidity, but appears~     to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic~     approach has not been reproduced, and the investigators propose to validate their algorithm~     at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary~     data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the~     investigators are well-suited to perform this investigation. A surgical approach that is~     tailored to the patient's cancer biology is rational, supported by the recent literature, and~     medically compelling since the co-morbidities of many obese, low-risk EC patients put them at~     significantly increased perioperative risk for complete lymphadenectomy.~   "
156875|NCT01512758|"~     This is an open-label, multicenter, phase 1 study of alisertib in East Asian patients (eg,~     patients from countries including but not limited to Singapore, Hong Kong, Taiwan, and South~     Korea) with either relapsed or refractory advanced solid tumors or lymphomas for which no~     effective standard treatment is available.~   "
156876|NCT01512745|"~     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor~     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The~     investigators' phase I study has shown that the drug's toxicity is manageable and the maximum~     tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib~     can improve progression free survival or overall survival compared with placebo in patients~     with metastatic gastric carcinoma who failed two lines of chemotherapy.~   "
156877|NCT01512732|"~     Today, no non-verbal auditory stimuli that assess mental processing are available in Israel.~     The goal of this study is to make available a validated set of auditory stimuli in Israel. We~     created a computerized Hebrew version of the Montreal Affective Voices (MAV). The MAV is a~     novel tool for assessing mental processing. The MAV consists of 90 nonverbal affect bursts~     corresponding to nine different emotions (such as anger, fear, happiness etc.) recorded by~     ten different actors. The uniqueness of these affective bursts is that they do not contain~     verbal context, but rather express affective moods using the vowel /a/ (as in apple). In~     this study, the investigators will verify the new Hebrew version of MAV in healthy control~     groups. Next, the investigators will compare the mental processing ability in young vs. old~     population, using the MAV test. In addition, the investigators will assess mental processing~     in two pathologic study groups (Parkinson's disease, major depressive disorder) using the MAV~     test. The investigators intend to use the MAV tool in future research in Parkinson's disease~     and depression.~   "
156878|NCT01512719|"~     POEM has recently described as an alternative treatment for achalasia in humans. In this~     procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus.~     In this study we aim to perform POEM on achalasia patients.~   "
156879|NCT01512706|"~     Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth~     disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family~     Picornaviridae.~      Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in~     the Asia-Pacific region. Notably, there is evidence that the most severe cases from these~     epidemic outbreaks are associated with neurological disorders with CNS involvement caused by~     EV71 infection. Because of these EV71 infection-related public health issues, the research~     and development of EV71 vaccine candidates have been heavily promoted.~      Recently, several EV71 vaccine candidates have been evaluated in animals but no final results~     of clinical trials, including inactivated vaccine, attenuated vaccine, subunit vaccine, DNA~     vaccine, epitope peptide vaccine, virus-like particles (VLPs).~      Basing on the previous studies of elicited protection in mice and rhesus monkeys, a~     formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA~     in China, Dec. 2010. The phase I clinical trial was completed, during four months, in Guangxi~     Province, China. The phase II clinical trial has been carried out, from July 2011. The~     purpose of phase II is to evaluate the safety and efficacy of the formalin-inactivated EV71~     vaccine in Chinese infants (from 6 to 36 months old).~   "
156880|NCT01512693|"~     This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50~     milligram (mg) dose of MK-0822 in participants with and without moderate hepatic~     insufficiency (abnormal liver function) in order to determine to what degree hepatic~     dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that~     plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to~     that in matched healthy participants following a single 50 mg oral dose.~   "
156881|NCT01512680|"~     Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients~     which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis~     is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better~     quality of life. 60 patient will be enrolled and followed during one year.~   "
156882|NCT01512667|"~     This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib~     administered to participants with impaired renal/kidney function to those of a healthy~     matched control group. The primary hypothesis is that plasma AUC0-∞ of odanacatib in~     participants with impaired renal function is similar to that in matched healthy participants~     following a single 50 mg oral dose.~   "
156883|NCT01512654|"~     The primary purpose of this study is to see whether a tool that predict blood glucose and~     suggest therapy advices can help type 1 diabetic patients.~   "
156884|NCT01512641|"~     Schizophrenia beginning before 18 years is a clinical entity not well known because of its~     low incidence and difficulties in the clinical diagnosis.~      However, in the investigators clinical practice, due to the specialization of the~     investigators service, the investigators are led to hospital to receive important feel active~     of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text~     revision (DSM IV-TR) precose schizophrenia.~      The work of us team on the theme of the relationship between Pervasive Developmental~     Disorders and precose Schizophrenia led us to hypothesize that a number of children in care~     in the medical and educational institutes, hospitals and day shelters therapeutic part-time~     symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not~     diagnosed.~      The main goal is to estimate the prevalence of dissociative disorders in a population of~     children in care institutions and medical education in child psychiatry in hospitals and~     others structures.~   "
156885|NCT01512628|"~     The investigators administered different kinds of colloids before transfusion of red blood~     cell to patient undergoing total hip replacement arthroplasty. The investigators will compare~     the differences of changes in rotational thromboelastometry (ROTEM) data among them.~   "
156886|NCT01512615|"~     The aim of the study is to describe the effect and meaning of an integrated rehabilitation~     programme, consisting of physical training and psycho-educational care, for patients treated~     for infective endocarditis.~      The hypothesis is, that integrated rehabilitation can improve mental health, physical~     capacity and other factors.~   "
156935|NCT01511978|"~     Hypothesis: 3,4-Diaminopyridine base (3,4-DAP) improves Lambert-Eaton Myasthenic Syndrome~     (LEMS)-related weakness.~   "
156887|NCT01512602|"~     Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior~     Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed~     supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with~     self behavior and personality traits within the spectrum of borderline personality disorder.~      Hypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT)~     after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on~     self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and~     consumption of hospital services in patients with symptoms within the spectrum of borderline~     personality disorder (BDP).~      Method: The investigators will include 160 patients in the randomized trial to investigate~     whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive~     psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm~     behavior and personality traits within the spectrum of borderline personality disorder. The~     trial will meet strict criteria for high quality randomized trials, and will hopefully help~     to establish evidence for the treatment of this patient group at higher risk of later~     suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks.~   "
156888|NCT01512589|"~     The goal of this clinical research study is to learn how safe and effective proton-beam~     therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in~     combination with chemotherapy in patients with esophageal cancer.~      PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area~     of the body while affecting as little of the surrounding normal tissue as possible. PBT is a~     newer technology that is designed to further reduce the amount of radiation that affects the~     surrounding normal tissue. However, this is still being studied.~   "
156889|NCT01512576|"~     This physiological study examines whether acupuncture exerts short-term effects of analgesic~     mechanisms in patients with chronic whiplash pain. More specifically, it is examined whether~     acupuncture activates brain-orchestrated pain inhibitory action.~   "
156890|NCT01512563|"~     Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common~     Covered Metallic Biliary Stent.~   "
156891|NCT01512550|"~     The purpose of this prospective, randomized study is to evaluate the importance of restoring~     the exact individual hip biomechanics during total hip arthroplasty.~   "
156892|NCT01512537|"~     The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in~     treatment of vitamin D deficiency.~   "
156893|NCT01512524|"~     The primary objective is to assess the long-term impact of hormonal deficiency on Quality of~     Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.~   "
156894|NCT01512511|"~     There is no general agreement about the ideal gas for pneumoperitoneum. CO2, now in common~     use, has not compared to N2O sufficiently to disclose which one has minimal physiological~     invasiveness characters. Assigned randomly to carbon dioxide or nitrous oxide group, the~     hemodynamic and respiratory parameters (heart rate, mean arterial blood pressure, end-tidal~     CO2, minute ventilation, and O2 saturation) before pneumoperitoneum and during it were~     recorded. Pain, as perceived by patients, is measured 2, 4 and 24 hours after the procedure~     by visual analogue scale. Vomiting and use of analgesics and antiemetics were recorded and~     compared.~   "
156895|NCT01512498|"~     The study will evaluate the prevalence and characteristics of vulvovaginal graft versus host~     disease (VV- GVHD) in patients who underwent hematopoietic stem cell transplantation (HSCT)~     as girls or adolescents and will compare the prevalence, characteristics and severity of~     VV-GVHD before and after menarche.~   "
156896|NCT01512485|"~     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's~     Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75~     mg tablet under fed condition.~   "
156897|NCT01512472|"~     Men with localized prostate cancer requiring intermittent androgen deprivation therapy for~     biochemical recurrence following radical therapy will be asked to participate in a phase 4~     safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix~     (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.~   "
156898|NCT01512459|"~     The objective of this study was to compare the relative bioavailability of Venlafaxine MR~     Capsules 150 mg with Effexor XR Capsules 150 mg under Fed conditions in healthy adult human~     subjects.~   "
156899|NCT01512446|"~     The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long~     term treatment of osteoporosis.~   "
156900|NCT01512433|"~     The purpose of this study is to investigate the efficacy of acupuncture therapy combined with~     standard methadone maintenance therapy to the heroin addicts.~   "
156901|NCT01512420|"~     This prospective observational study will evaluate the efficacy and safety of second-line~     Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer~     with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study~     is to identify from baseline clinical and demographic patient characteristics prognostic~     factors related to overall survival with second-line Tarceva treatment. Data will be~     collected from eligible patients for up to 2 years.~   "
156902|NCT01512407|"~     We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection~     in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver~     and thus improve survival. The aim of this study is to compare the survival of patients~     undergoing liver resection plus post-operative TACE versus liver resection alone.~   "
156903|NCT01512394|"~     Current management of elective bowel surgery typically involves performing a preoperative~     bowel preparation (bowel prep) in many instances; however, this practice is not~     standardized at most institutions. Over the years, bowel preps have been used in an attempt~     to decrease the risk of complications associated with gastrointestinal surgery. However,~     there is limited adequate data to support this clinical management in the pediatric patient~     population. The investigator plans to perform a prospective, randomized study of our~     pediatric surgical patients who will undergo an elective bowel resection or ostomy closure to~     assess if a bowel prep prior to surgical intervention affects their postoperative course. The~     aim of this study is to evaluate for differences that may alter and improve future~     management.~   "
197848|NCT00973349|"~     This study will evaluate the safety and immunogenicity of different combinations of A/H1N1~     S-OIV (swine flu) vaccine in non-elderly and elderly adults.~   "
156904|NCT01512381|"~     The purpose of this study is to determine whether cardiac resynchronization therapy (CRT) is~     superior to interventricular right ventricle (RV) septal pacing in respect of reverse~     remodeling (LV ESD) and morbidity in patients with less preserved (less than 45%) ejection~     fraction (EF), persistent/permanent atrial fibrillation (AF) who successfully received~     atrioventricular (AV) junction ablation ablation (100% pacemaker dependency)~   "
156905|NCT01512368|"~     We evaluated the effect of two weeks of intensive supervised physical activity in serum~     fibroblast growth factor 21 (FGF21) levels.~   "
156906|NCT01512355|"~     Postoperative agitation in children is a well-documented clinical phenomenon with incidence~     ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the~     pediatric population and there is now increasing evidence to support the use of this drug as~     sedative and anesthetic adjunct in children. The purpose of this study is to determine~     whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.~   "
156907|NCT01512342|"~     Given the lack of evidence in support of pacing self-management for patients with chronic~     fatigue syndrome (CFS), it is examined whether physical behavior and health status of~     patients with CFS improve in response to a pacing self-management program. The effects of~     pacing will be compared with those observed when applying relaxation therapy to patients with~     CFS.~   "
156908|NCT01512329|"~     Given the lack of evidence in support of pacing self-management for patients with musltiple~     sclerosis (MS), it is examined whether physical behavior and health status of patients with~     MS improve in response to a pacing self-management program. The effects of pacing will be~     compared with those observed when applying relaxation therapy to patients with MS.~   "
156909|NCT01512316|"~     The present study investigates the effect of d-cycloserine on learning and unlearning of fear~     in healthy humans and its underlying effect on the amygdala.~      As a second objective, the effect of genotype on fear learning will be studied.~   "
156910|NCT01512303|"~     The overarching aim of this proposal is to research whether meditation-based treatments are~     effective in decreasing posttraumatic stress disorder (PSTD) symptoms in veterans, which~     complementary and alternative (CA) treatments are most effective, and how individual~     differences predict treatment efficacy.~   "
156911|NCT01512290|"~     Auditory verbal hallucinations (AVH) are a characterising symptom of schizophrenia. In the~     majority of patients, these AVH respond well to antipsychotic medication. Yet, a significant~     minority continues to experience frequent AVH despite optimal pharmacotherapy. The number of~     alternative treatment options for this medication resistant group is currently low and most~     of them focus on coping with the hallucinations. Transcranial magnetic stimulation (TMS), in~     contrast, is a non-invasive technique of influencing cortical excitability. This technique~     has the potential to actually decrease the frequency and severity of medication resistant~     hallucinations.~      Several previous studies have assessed efficacy of low frequency rTMS, with contradicting~     results. A previous large study by the investigators group could not demonstrate efficacy of~     low frequency rTMS. A new stimulation protocol using theta burst rTMS (TBS) could provide a~     more effective therapeutic option.~      Objective: The present study aims to examine the efficacy of TBS on the severity of AVH.~     Study design: The objectives are tested in a randomized double blind placebo-controlled~     trail.~      Study population: 60 patients with the diagnosis of schizophrenia, schizoaffective disorder,~     schizophreniform disorder or psychosis not otherwise specified with frequent auditory verbal~     hallucinations will be included.~      Intervention: The participant will receive either 10 TBS treatments or 10 placebo treatments~     consisting of 900 pulses each with a 30 minute interval on the left temporoparietal area,~     distributed over 5 treatment days. Stimulation will be at 80% of the motor threshold.~      Main study parameters/endpoints: the main study parameter is the change in the severity of~     the AVH. The secondary study parameter is the number and severity of adverse events.~   "
156912|NCT01512277|"~     The purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy~     volunteers of the vaccine candidate against schistosomiasis named Bilhvax.~   "
156913|NCT01512264|"~     In this study the investigators will examine the efficacy of (1) navigated excitatory~     repetitive transcranial magnetic stimulation (nerTMS) and (2) a combination of nerTMS and~     constraint induced aphasia therapy (CIAT) as post-stroke aphasia rehabilitation methods. The~     investigators expect that these new types of rehabilitation, either nerTMS alone or in~     combination with CIAT, will help patients with aphasia return to their lives as they were~     prior to the stroke.~   "
156914|NCT01512251|"~     This is a phase 1/2 clinical trial with the goal of determining whether the addition of the~     investigational agent BKM120 to vemurafenib will lead to improved 6-month progression-free~     survival in patients with BRAFV600E/K mutant melanoma.~   "
156915|NCT01512238|"~     The purpose is to study if different factors influence medicine adherence in elderly people.~     In this study number of generic substitution and use of non-prescription drugs, herbal~     medicine and dietary supplement is in focus.~   "
156916|NCT01512225|"~     The purpose of this study is to evaluate the safety and efficacy of Domperidone in those~     mothers who are identified as having difficulty with breast milk production to meet the~     nutritional needs of their infant in the neonatal intensive are unit hospitalization setting,~     and to determine how it should be considered in the care of mothers and their preterm infants~     without causing undesirable effects to either the mother or infant.~   "
156917|NCT01512212|"~     Evaluation of the effectivity of the new thyroid fine needle aspiration biopsy (FNAB)~     apparatus of which patented from Turkish Patent Institute.~   "
156918|NCT01512199|"~     This is a Phase 1b/2 study. In Phase 1b portion, subjects will know the treatment they are~     receiving . Subjects will receive U3-1287 with trastuzumab plus paclitaxel . The phase 1b~     portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe in~     subjects with metastatic breast cancer. In phase 2 portion, subjects will be blinded to the~     treatments they are receiving . Subjects will receive either trastuzumab plus paclitaxel with~     U3-1287 or trastuzumab plus paclitaxel and placebo.The phase 2 portion will determine if~     adding U3-1287 to trastuzumab plus paclitaxel will be safe and improve survival in subjects~     with metastatic breast cancer.~   "
156919|NCT01512186|"~     The purpose of this study is to investigate if 14 weeks of pazopanib therapy prior to surgery~     (nephrectomy) is of benefit to patients with metastatic renal cancer. Ninety-five patients~     will be recruited into his study.~   "
156920|NCT01512173|"~     There is an unsatisfied medical need for a first-line treatment of localized uncomplicated~     proliferating Infantile Hemangioma with a good benefit/risk profile.~      Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which~     is a topical gel adapted to paediatric use.~      The objective of this study is to evaluate topical propranolol efficacy and safety in the~     management of localized hemangioma.~   "
156921|NCT01512160|"~     The purpose of this study is to evaluate the overall pain relief of a single dose of~     PF-04531083 against placebo following third molar extraction.~   "
156922|NCT01512147|"~     The investigators want to know if using the study drug dexmedetomidine will improve nerve~     wave readings during neurosurgery. These readings are done many times during surgery while~     the patient is asleep. The readings look at how nerves are working and let the operating team~     know if nerves are hurt during surgery. If the readings tell that nerves are not working~     correctly, the surgeons can help while changing the way of operating.~      The study drug will be used in addition to the general anesthesia that a patient is given.~     The nerve readings that the investigators get while using the study drug will be compared~     with nerve readings that the investigators get while not using the study drug.~      The study hypothesis is that dexmedetomidine does not change nerve readings.~   "
156923|NCT01512134|"~     The purpose of this clinical study is to investigate the safety and efficacy of deep brain~     stimulation (DBS) as a treatment option for obesity.~   "
156924|NCT01512121|"~     The overall objective of this study is to assess patterns of fMRI cortical activation with~     spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define~     cortical correlates, as well as to investigate cortical representations of pain and pain~     relief and the interactions therein, in the setting of neuropathic leg pain and SCS.~   "
156925|NCT01512108|"~     This trial was conducted in Japan. The aim of this trial was to evaluate the safety and~     efficacy of once daily administration of liraglutide in combination with an oral~     anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently~     controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either~     glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at~     unchanged type and dose.~   "
156926|NCT01512095|"~     This trial is conducted in Europe and United States of America (USA). The aim of this trial~     is to examine the bioequivalence (assessment of the expected biological equivalence of two~     pharmaceutical drug products with identical active ingredient) of Norditropin® versus~     Nutropin AQ® in healthy adult volunteers.~   "
156927|NCT01512082|"~     Delayed onset muscle soreness is defined as the sensition of pain and discomfort in skeletal~     muscles that occurs after eccentric muscle actions or strenuous exercise like a marathon.~   "
156928|NCT01512069|"~     Life style interventions that promote exercise and a healthy diet, which have the potential~     to improve health-related quality of life (HRQOL), may be particularly appropriate for cancer~     survivors. The previous studies suggested that a key strategy to implement sustainable~     healthy behavior and improve health was providing appropriate feedback and promoting~     self-efficacy. Web-based program enables to provide the feedback in a timely manner on a~     daily basis, to continue the healthy behaviors.~      Therefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning~     program, and whether the program can promote significantly greater changes in behavioral~     outcomes [goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and~     diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)], stage of changes~     for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and~     self-efficacy in implementing goal of exercise and diet among breast cancer survivors in~     Korea was examined.~      Hypotheses were following:~        1. Survivors of a group participating in a web-based, stage-matched Exercise and Diet~          Planning program (hereinafter called the 'intervention group') will show a more advanced~          stage of change for exercise and diet compared to survivors in the control group.~        2. The intervention group will show a higher proportion of attaining goal of exercise (or~          higher level of energy expenditure of aerobic exercise) compared to the control group.~        3. The intervention group will show a higher proportion of attaining goal of diet (or~          higher level of diet quality) compared to the control group.~        4. The intervention group will show a better HRQOL level compared to the control group.~        5. The intervention group will show a better self-efficacy level compared to the control~          group.~        6. The intervention group will show a lower fatigue level compared to the control group.~        7. The intervention group will show less anxiety compared to the control group.~        8. The intervention group will show less depression compared to the control group.~   "
156929|NCT01512056|"~     The purpose of this study is to evaluate the antibody response in dialysis patents to each of~     the three influenza vaccine strains included in the licensed seasonal flu vaccine~     (Formulation 2011-2012).~   "
156930|NCT01512043|"~     There is a demand for explorative and comparative studies on various non-pharmaceutical~     efforts in treating and helping chronic obstructive pulmonary disease patients. This study~     has been developed in light of this need. The main purpose of the project is to test whether~     a device guided breathing control system can decreasing the feeling of breathlessness in~     patients with moderate stage and severe stage of COPD. In addition the study could shed light~     on whether a reduced feeling of breathlessness can lead to improved physical function, and~     less experience of other symptoms (I.e., depression, anxiety, sleeping difficulties, fatigue,~     pain) and provide a better quality of life for patients with COPD.~   "
156931|NCT01512030|"~     Diabetes mellitus type I is an increasing burden for more and younger children. Therapy~     should avoid long-term complications as macrovascular diseases and diabetic nephropathy,~     retinopathy and diabetic neuropathy (DN). There is considerable uncertainty about the~     prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic~     criteria. Nerve conduction velocity studies are regarded as the gold standard for~     investigating neuropathies.~      We plan a prospective study by investigating the peripheral nerve conduction velocity in a~     population of diabetic children. At the same time-points, we will do a neurological~     examination using the Young Score, a clinical score of peripheral neuropathy [10]. The~     results obtained will be related to other long-term vascular complications (nephropathy,~     retinopathy), glycaemic control, duration of diabetes, insulin dose regime, hours of~     sports/week, and BMI~   "
156932|NCT01512017|"~     This study is a multi-center, randomized, open and paralleled positive control study for~     evaluating the safety and efficacy of Veloderm in treatment of split-thickness skin graft~     donor sites. The result implies that Veloerm can do it better than Vaseline gauze in~     accelerating and promoting wound healing of skin graft donor sites. The present study have~     indicated that high permeability of Veloderm dressing to oxygen and water vapor.~   "
156933|NCT01512004|"~     The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine~     Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese~     population with urgent micturition, frequent micturition and/or urge urinary incontinence.~   "
156934|NCT01511991|"~     The purpose of this study is to determine sevoflurane's dose-dependent effect on left~     ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of~     lateral mitral valve annular velocity at three different sevoflurane concentrations would be~     analyzed by using intraoperative transesophageal echocardiography (TEE)in cardiac surgery~     patients.~   "
156936|NCT01511965|"~     Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of~     melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and~     social, that sounds a lot about the quality of life. Currently the standard treatment for~     vitiligo is ultraviolet ray (UV), but it only allows a 50% repigmentation of lesions in half~     of patients. The applications of autologous epidermal cells in the liquid phase is a~     promising new therapeutic approach of vitiligo.~      The main goal of this study is to compare prospectively the repigmentation of vitiligo~     lesions induced by application of autologous epidermal cells in liquid phase associated with~     light therapy and light therapy alone.~      Study's secondary goals: compare the applications of epidermal cells to phototherapy alone~     and phototherapy, in respect of:~        -  Obtain a repigmentation> 70% (threshold considered aesthetically relevant)~        -  The occurrence of adverse events~        -  Patient satisfaction regarding the efficacy and safety of treatment~   "
156937|NCT01511952|"~     This is a multi-site study of 272 premature infants >32 weeks who served in a randomized~     investigation (in morning or afternoon) where they served as their own controls. The infants'~     HR, RR, O2sats were measured with and without the implementation fo live music. The live~     interventions included songs of kin, selected by parents, the gato box and ocean disc played~     through entrained methods by a music therapist. The infants were evaluated within a two week~     period and in total each day including feeds, voids, activity level and sleep.~   "
156938|NCT01511939|"~     The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug~     (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who~     are also taking anticoagulant or antithrombotic medications.~   "
156939|NCT01511926|"~     The most common pain-relievers used by patients with rheumatic disorders are called~     non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are effective and well~     documented, but they can cause ulcers and gastrointestinal side effects. Vimovo™ is a tablet~     containing naproxen (NSAID) and a gastroprotective agent called esomeprazole. Patients with~     rheumatic disorders, who are at risk for developing gastrointestinal side effects, and where~     lower doses of naproxen or other NSAID treatment is not considered sufficient, could use this~     tablet. The regulatory authorities in many European countries have approved the use of~     Vimovo™, but they would like to understand how various factors influence the doctors'~     decision to prescribe the tablet and what is characterizing the patients receiving it. The~     aim of the study is to answer these questions.~   "
156940|NCT01511913|"~     The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the~     treatment of unresectable or metastatic melanoma in the post-approval setting.~   "
156941|NCT01511900|"~     The primary objective of the study is to evaluate the safety of escalating multiple doses~     over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D).~      Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of~     escalating multiple doses of CAT-1004 in patients with T2D.~   "
156942|NCT01511887|"~     The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term~     20-28 days old newborn referred to Bandarabbas children' hospital in 2011.~   "
156943|NCT01511874|"~     The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the~     treatment of subjects with prostate cancer.~   "
156944|NCT01511861|"~     Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic~     goal that is difficult to achieve with current blood glucose monitoring technology. Home~     blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of~     severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy~     to operate glucose monitoring in DM patients for strict glycemic control cannot be~     overemphasized.~      The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an~     acceptable mean relative error when compared to acceptable invasive blood glucose~     measurements.~      The primary objectives of the trial are to determine:~        1. Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels~          compare to the standard glucose blood test~        2. Creating database of glucose levels readings utilizing the Glucometer GM-205.~   "
156945|NCT01511848|"~     Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of~     combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional~     iron overload~      Primary Outcome Measures:~      • The primary outcome measure is to assess efficacy in lowering serum ferritin level(the~     change in serum ferritin compared to baseline) with combining DFP and deferasirox compared to~     combined DFP and DFO in conditions with severe chronic iron overload; showing an up-trend of~     SF over previous 12 months on single chelator.~      Secondary Outcome Measures:~      • The secondary outcome measure is to determine the number of patients who will develop~     adverse events in order to assess safety upon administering the drugs in combination (DFP and~     DFX) compared to the combination of DFO and DFP.~   "
156946|NCT01511835|"~     The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational~     diabetes in high risk pregnant women.~   "
156961|NCT01511640|"~     Cannabis is the most commonly used illicit drug in the United States, and its use is~     associated with rates of development of abuse and dependence, treatment admission and relapse~     that are comparable to other illicit drugs. Currently there is no effective pharmacological~     treatment for cannabis-use disorders. The purpose of the present study is to evaluate the~     ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a~     medication for cannabis-use disorders.~   "
156962|NCT01511627|"~     The investigators hypothesize that a spinal anesthetic administered prior to the induction of~     general anesthesia will result in reduced need for pain medication and reduced postoperative~     pain, as well as reduced hospital stay following a total abdominal hysterectomy.~   "
156973|NCT01511484|"~     This study investigated whether illustration of the facial appearance benefits of fruit and~     vegetable consumption is able to motivate increased intake of this food group. The~     investigators hypothesize that individuals witnessing illustrations of the impact of a~     healthy diet will exhibit improvements in diet relative to a control group receiving only~     information on the health-benefits of this food group.~   "
157004|NCT01511081|"~     The goal of this clinical research study is to compare 2 types of radiotherapy, stereotactic~     body photon radiotherapy (SBRT) and stereotactic body proton radiotherapy (SBPT). Researchers~     would like to compare the side effects, quality of life, and cancer control.~   "
156947|NCT01511822|"~     Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and~     endocrine abnormalities and clinical symptoms.~      The primary defect in PCOS consists of an abnormal androgen synthesis and secretion,~     particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers,~     explaining the frequent association of PCOS with these metabolic conditions.~     Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and adrenal~     androgen secretion and suppresses sex hormone-binding globulin synthesis from the liver. It~     results in an increase in free, biologically active androgens which are related to clinical~     signs such as hirsutism, acne, seborrhea, and alopecia.~      Combined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely~     used in this group of patients providing clinical improvement in the areas of excessive hair~     growth, unpredictable menses, acne, and weight gain.~      More recent studies outlined a deficiency in myo-inositol in women with PCOS and~     insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and it~     plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle~     trafficking, and chromatin remodeling. It is a precursor in the synthesis of~     phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers.~      It has been reported that the administration of myo-inositol reduces serum insulin, decreases~     serum testosterone and enhances ovulation.~      Due to the different beneficial actions, the aim of the present study is to evaluate the~     clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl~     estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin~     resistance.~   "
156948|NCT01511809|"~     The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior~     proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable~     suppressed viremia and no prior virologic failures.~   "
156949|NCT01511796|"~     The purpose of this study is to examine the effects of a combination of Botulinum Toxin (BT)~     and Upper Limb (UL) rehabilitation compared to BT only on UL motor function in adults with~     spasticity after stroke using a pre-post design. The research question is whether combination~     of BT and UL rehabilitation compared to BT only is more effective in improving the UL~     function, range of motion and pain.~   "
156950|NCT01511783|"~     The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to~     evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when~     administered to healthy elderly subjects.~   "
156951|NCT01511770|"~     The objective of this study was an open-label, randomized, 2-way crossover to compare the~     single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®)~     200 mg fluconazole tablets under fasting conditions.~   "
156952|NCT01511757|"~     The objective of this study was an open-label, randomized, 2-way crossover to compare the~     single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®)~     200 mg fluconazole tablets under fed conditions.~   "
156953|NCT01511744|"~     Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological~     Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to the~     influenza immunity of age 3 and older population. Phase III clinical study was conducted in~     Jintan City, Jiangsu Province in May, 2006. Trial results showed that this vaccine had good~     safety and immunogenicity. Hualan Bio Influenza Vaccine obtained its production~     approval(China Drug Approval No.: S20083016) for marketing on April 3rd, 2008.~      In order to monitor and evaluate the safety and protective effect against influenza~     administered on age 3 and older population, therefore we conduct the phase IV clinical trial~     of the licensed Influenza Vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml).~   "
156954|NCT01511731|"~     The objective of this study was to compare the single-dose relative bioavailability of Reddy~     Cheminor and Merck &Co, pepcid 40 mg famotidine tablets under fasting conditions.~   "
156955|NCT01511718|"~     This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single~     dose, crossover, oral bioequivalence study.~   "
156956|NCT01511705|"~     This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single~     dose, crossover, oral bioequivalence study.~   "
156957|NCT01511692|"~     This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects~     of liraglutide on energy intake in subjects with type 2 diabetes.~   "
156958|NCT01511679|"~     This is a multi-site study of adolescents 12-21 years-of-age to evaluate the long and~     shorter-term effect of adolescent alcohol use on the developing brain.~   "
156959|NCT01511666|"~     Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter~     clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest~     compression device, extracorporeal life support (ECLS) and early invasive investigation and~     treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary~     angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed~     cardiac origin compared to standard of care. It is hypothesized, that above stated~     hyperinvasive approach might improve outcome of out-of hospital cardiac arrest victims.~   "
156960|NCT01511653|"~     The investigators are undertaking a multi-center, 13000 subject validation study of several~     biomarkers for early detection of colon cancer. There are stool based biomarkers and blood~     based biomarkers being validated in this study. The biomarkers will be compared with~     colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards~     for colon cancer screening. This is an NCI-early Detection Research Network funded project.~     The population targeted for this study are those persons undergoing colonoscopy for~     screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood~     and stool samples as well as specific data regarding their GI and general medical history and~     concomitant medications. If subjects are interested in participating, arrangements will be~     made to see them. The informed consent process will take place, blood will be obtained, data~     will be obtained, and the stool kit described and given to the subject to take home. Stool~     samples will be sent back to the University of Michigan using prepaid mailing labels.~   "
156986|NCT01511315|"~     This study aims to see if patient quality of life can be approved after treatment with an~     injectable medication called ustekinumab for the treatment of generalized psoriasis. The~     investigators hypothesize that the investigators will see improvement in quality of life.~   "
156963|NCT01511614|"~     Background:~      - Smoking is thought to cause changes in the brain that lead to addiction and craving.~     Smokers who try to quit experience nicotine withdrawal symptoms that include irritability,~     anxiety, and difficulty concentrating. These symptoms make it difficult for people to stop~     smoking. Many people say that they continue smoking to help relieve these symptoms, often~     within the first week after trying to quit. Researchers want to study what is happening in~     the brain to cause these symptoms, which may help identify new ways to successfully quit~     smoking.~      Objectives:~      - To study nicotine withdrawal symptoms and brain function in smokers who stop smoking for 36~     hours.~      Eligibility:~      - Individuals between 18 and 55 years of age who smoke at least 10 cigarettes per day.~     Participants must be able to stop smoking for 36 hours on two occasions.~      Design:~        -  This study will involve three visits to the National Institute on Drug Abuse.~        -  Participants will be screened with a medical history and physical exam. Blood and urine~          samples will be collected, as well as breath samples to test for recent alcohol use.~          Participants will also fill out questionnaires and learn about the tests at the next two~          visits.~        -  Before each imaging visit, participants will stop smoking for 36 hours. Before one~          visit, participants will wear a nicotine skin patch. Before the other visit,~          participants will wear a placebo (dummy) patch with no nicotine. Participants will not~          be told which type of patch they are wearing. Participants will measure the level of~          carbon monoxide in their breath during both of these nonsmoking periods. They will also~          complete questionnaires about mood and cigarette cravings.~        -  Participants will have two study visits with imaging studies to measure brain activity.~          Each imaging visit will last about 9 to 10 hours. The visit will involve two separate~          1.5- to 2-hour scan sessions (a morning scan and an afternoon scan). These scan sessions~          will involve tests of concentration, memory, and reaction time. Other tests and~          questionnaires will also be completed outside of the scanner before and after the~          sessions.~   "
156964|NCT01511601|"~     Background:~      - Some clinical trials require larger amounts of plasma and white blood cells than can be~     collected through simple blood donations. Apheresis is a procedure used to collect parts of~     the blood for study and return the rest of the blood to the donor. Healthy volunteers who~     provide plasma and white blood cells for study may need to give multiple donations.~     Researchers want to use apheresis to collect plasma and white blood cells from healthy~     volunteers in Mali.~      Objectives:~      - To collect plasma and white blood cells from healthy volunteers in Mali.~      Eligibility:~        -  Healthy volunteers between 18 and 55 years of age.~        -  Volunteers must be in National Institute of Allergy and Infectious Diseases clinical~          trials.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          provide basic blood and urine samples.~        -  Participants will have apheresis to collect plasma and white blood cells for study.~          Before each collection, they will provide a small blood sample for testing. They will be~          monitored during and after donation to prevent side effects.~        -  Under this protocol, participants may have apheresis up to six times per year.~        -  No treatment will be provided as part of this protocol....~   "
156965|NCT01511588|"~     Background:~      - The body produces gonadotropin-releasing hormone (GnRH) about every 2 hours. GnRH travels~     through the bloodstream to the pituitary gland, where it stimulates the gland to produce~     hormones called gonadotropins. These hormones stimulate the testicles or ovaries. The~     testicles produce testosterone and develop sperm. The ovaries produce estrogen and prepare~     for ovulation. Normal estrogen and testosterone levels are required for puberty. Some people,~     however, have either low levels or total lack of GnRH. This can cause problems with puberty~     and fertility. Researchers want to study people with low or no GnRH to better understand how~     it affects puberty and fertility.~      Objectives:~      - To study disorders of GnRH production.~      Eligibility:~        -  Adult men and women at least 18 years of age with low or no gonadotropin levels.~        -  Adolescents between 14 and 18 years of age with low or no gonadotropin levels.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have tests to look at their hormone levels. Blood samples may be~          collected after taking different drugs, including insulin and cortisone. A 24-hour urine~          sample will be collected.~        -  Participants will have imaging studies to look at bone and brain development. They will~          also have ultrasounds of the kidneys, abdomen, and reproductive organs.~        -  Tests of smell and hearing will be used to look for abnormalities in these senses.~   "
156966|NCT01511575|"~     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in~     the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers~     related to cancer.~      PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute~     myeloid leukemia or other transient myeloproliferative disorder.~   "
156967|NCT01511562|"~     The purpose of this study is to find out what effects (good and/or bad) treatment with~     chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary~     CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell~     lymphoma is not known.~   "
156968|NCT01511549|"~     Primary Objective:~      To assess the safety and tolerability of SAR113945 in Japanese patients with knee~     osteoarthritis after ascending single intra-articular doses~      Secondary Objective:~      To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis~     after ascending single intra-articular doses~   "
156969|NCT01511536|"~     Primary Objectives:~        -  To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel~          administered as a 1-hour infusion every 3 weeks in combination with oral daily~          abiraterone acetate and prednisone in participants with metastatic Castrate-resistant~          prostate cancer (CRPC)~        -  To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone~          acetate and prednisone in terms of prostate-specific antigen (PSA) response rate.~      Secondary Objectives:~        -  To characterize the safety profile of the combination~        -  To evaluate the pharmacokinetic profile of cabazitaxel and abiraterone in the proposed~          combination and dosing schedule~        -  To assess preliminary antitumor activity of the combination in terms of progression-free~          survival, PSA progression free survival and objective response rate, and overall~          survival~   "
156970|NCT01511523|"~     A research study of a compound containing vitamin E, silymarin and carnitine, three over the~     counter supplements. The investigators hope to learn if the new supplement can safely and~     successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD).~   "
156971|NCT01511510|"~     This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a~     number of ascending doses administered once daily for 14 days in healthy volunteers.~   "
156972|NCT01511497|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of PF-04427429 in healthy women.~   "
156987|NCT01511302|"~     The purpose of this study is to determine whether RNS60, in combination with budesonide, is~     safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared~     to a 28-day control period.~   "
156974|NCT01511471|"~     Clopidogrel administration is commonly prescribed in patients undergoing percutaneous~     coronary intervention, in patients with previous stroke and in patients under chronic~     hemodialysis via fistulae. Patients with chronic renal failure present lower clopidogrel~     response compared to those with normal renal function. Ticagrelor is a new oral direct-acting~     antagonist, which provides greater platelet inhibition in both clopidogrel responders and~     non-responders. It has also been shown that in patients with chronic kidney disease~     (creatinine clearance <60 mL/min)ticagrelor achieved an absolute risk reduction of~     cardiovascular death, myocardial infarction, and stroke greater than that of patients with~     normal renal function. Clopidogrel resistant patients as assessed by VerifyNow~     P2Y12(Accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily~     for 15 days. Platelet reactivity will be determined at the end of the treatment period.~     Bleeding events, major adverse cardiac events and any side effects until Day 15 will be~     reported in a descriptive manner.~   "
156975|NCT01511458|"~     The purpose of this blinded, multi-center, prospective, case-controlled study is to compare~     the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester~     prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG [β-hCG] or total~     hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening) in~     a general screened population.~      The performance characteristics of these two test modalities will be assessed relative to the~     clinical reference standard of genetic analysis of the fetus or phenotypic characterization~     and genetic analysis of the newborn.~   "
156976|NCT01511445|"~     This study randomizes neck and arm pain patients being treated with discectomy and anterior~     interbody fusion into two groups: one to receive a new ceramic implant and a control group~     with a more traditional plastic implant. The study will measure and compare pain and~     disability improvement with the two products over a period of two years. The fusion status~     will also be judged with plane x-rays and one CT scan.~   "
156977|NCT01511432|"~     The purpose of this study is to evaluate the relative bioavailability, safety, and~     tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.~   "
156978|NCT01511419|"~     The study hypothesis is that two doses of cold-adapted, live monovalent~     A/17/mallard/Netherlands/00/95 (H7N3) influenza vaccine will be safe and immunogenic in~     healthy adults.~   "
156979|NCT01511406|"~     The purpose of the present study is to examine whether cognitive behavior therapy will reduce~     depressive symptoms and increase self-esteem for patients with a first episode psychosis.~   "
156980|NCT01511393|"~     This study is conducted in the United States of America (USA). The aim of the study is to~     monitor the number of annual new cases of medullary thyroid carcinoma (MTC) and to establish~     a registry for these new cases in order to identify any possible increase related to the~     introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into~     the US market.~   "
156981|NCT01511380|"~     This study is designed to gain knowledge about effective interventions for reducing HIV risk~     in a high risk population. A new Risk Reduction Therapy for Adolescents (RRTA) will be~     compared to usual services received by youth in juvenile drug courts. It is expected that~     youth treated with RRTA will show greater reductions in substance use and risky sexual~     behaviors. Reducing HIV risk by effectively targeting substance use and risky sexual~     behaviors in high-risk groups such as juvenile drug court-involved youth could favorably~     impact society at multiple levels (individual, family, peer, community, fiscal).~   "
156982|NCT01511367|"~     This is a comparator study to assess safety and efficacy of Flutiform compared with~     Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe~     persistent, reversible asthma.~   "
156983|NCT01511354|"~     The need for certain components of food (i.e. protein) for critically ill children is not~     clear. It is important to have critically ill children fed adequately to prevent that their~     condition becomes worse or that recovery takes longer. Research methods used in the past to~     investigate the need for protein (Nitrogen Balance calculations), were not sensitive enough~     in severely ill children. The purpose of this study is to develop a new research method to~     determine the need for protein in severely ill children. In order to develop this new method,~     more information is needed on the way the body of these children uses protein in 24-hours. In~     the present study during 24-hours 8 children of age less than 18 years who are admitted to~     either the Pediatric ICU or the Cardiovascular ICU. Subjects will receive a standard~     nutrition, providing an age specific amount of protein (age ≤ 3: 2.52 protein g/kg BW.d; age~     4-6: 1.8 protein g/kg BW.d; age > 10: 1.44 protein g/kg BW.d) via tube feeding. They will~     also receive a mixture of stable isotopes of amino to investigate protein behavior in the~     body (protein kinetics) both by infusion in their blood and together with the nutrition.~     Blood will be drawn every 60 minutes during the 24-hour period and the behavior of protein~     and the concentrations in blood of amino acids and urea will be measured. Urine will be~     collected to measure nitrogen balance. The investigators will compare the results of this~     nitrogen balance method with the results of the stable isotope method. PIM2, PRISM, SIRS~     criteria will be used to get information on the severity of illness of the subjects. Also~     body weight and length as well as body composition of the subjects will be measured at the~     start and after the 24-hour period. Body composition will be measured by Bioelectrical~     Impedance Spectroscopy. Endpoints of the study are net whole-body protein synthesis (protein~     balance), 24-hour pattern of protein balance, 24-hour urea production, 24-hour nitrogen~     balance, 24-hour contribution of arginine kinetics to whole body protein breakdown, 24-hour~     muscle protein breakdown, splanchnic amino acid extraction and plasma amino acid~     concentrations.~   "
156984|NCT01511341|"~     Paediatric rheumatisms represent a large group of inflammatory and non-inflammatory diseases~     of the locomotion system. The annual rate incidence of children diagnosed with rheumatic~     disease in Switzerland (canton of Vaud) is 56.8 for 100'000 children. These children~     experience a chronic course of the disease impacting on their quality of life and family~     functioning. Their medical treatment is significant and may last for life. Caring for these~     children involves a multidisciplinary approach. Control of the disease and management of the~     symptoms becomes of foremost importance to minimise disability and pain. In addition to~     medical care, the supporting role of nurses in the care of children with rheumatic diseases~     and their family aims to limit the potential for further deformity, disability, and~     psychological complications. In particular, they play a key role in supporting the specialist~     team caring for patients with rheumatism disease, recognising poor disease control and the~     need for changes in treatment, providing a resource to patients on treatment options and how~     to access additional support and advice, and identifying best practice to achieve optimal~     outcomes for the patients and their family. Nurses also ensure the link between medical~     practitioner, other health providers, and family, thus play a key role in the follow-up care~     of the child and its family. Follow-up of children and their family can be ensured by regular~     telephone consultation (telenursing) made by experienced nurse specialists in rheumatology.~     However, the effectiveness of telenursing remains to be proven in children with chronic~     rheumatic diseases. The aim of this study is, therefore, to evaluate the effect of a~     telephone nursing intervention on the outcomes of family and children with rheumatism chronic~     disease.~      This randomised crossover, experimental longitudinal study will be carried out in the~     outpatient clinic of paediatric rheumatology of a tertiary referral hospital in canton of~     Vaud. The population will consist of children newly diagnosed with inflammatory rheumatologic~     diseases and one of their parent. The nurse-led intervention will consist of providing a~     monthly telephone call by a qualified and experienced nurse specialist in paediatric~     rheumatology and TN to ensure follow-up of the children and their family. The intervention~     will focus on providing affective support, health information, and aid to making decision.~   "
156985|NCT01511328|"~     The purpose is to evaluate whether implementation of primary human papillomavirus (HPV)~     screening in the screening programme for cervical cancer improves the programme in terms of~     better cancer protection and better cost efficiency.~   "
156988|NCT01511289|"~     In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg~     twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients~     with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase~     (CML-CP).~   "
156989|NCT01511276|"~     Physical inactivity and overweight are two accepted risk factors for breast cancer. However,~     because of their correlation it is not clear which is most relevant to risk. The~     investigators now set out to study whether physical activity in addition to weight loss by~     diet only, affects sex hormone levels, known to be related to breast cancer risk.~      In the SHAPE-2 study 250 healthy overweight/obese and physically inactive women are randomly~     allocated to a diet-induced weight loss group, a combined exercise- and diet-induced weight~     loss group or a control group. The aim of the first two intervention groups is to loose 5-6~     kg of bodyweight, either by dieting or mainly by increased physical activity. Measurements~     are performed at baseline and after 21 weeks, the end of the study period.~      The aim of this study is to provide insight into the effect of weight loss mainly driven by~     exercise compared to equivalent weight loss due to nutritional calorie restriction on breast~     cancer biomarkers.~   "
156990|NCT01511263|"~     In a proportion of patients with AL amyloidosis there is no improvement of cardiac function~     despite hematologic response to treatment. The aim of the study is to assess whether~     treatment with EGCG increases the rate of cardiac response in patients with AL amyloidosis~     who completed chemotherapy.~   "
156991|NCT01511250|"~     The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine~     (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In~     addition the antibody response to the four dengue virus serotypes will be evaluated.~   "
156992|NCT01511237|"~     The purpose is to evaluate the efficacy of maternal and infant perinatal antiretroviral~     prophylaxis intensification for the prevention of mother-to-child intrapartum transmission of~     HIV-1 in women receiving less than 8 weeks of antiretroviral prophylaxis during pregnancy.~   "
156993|NCT01511224|"~     Extensively and multi-drug resistant A. baumannii (AB) represent an emerging threat in~     hospitals locally and worldwide. There is lack of prospective comparative clinical data to~     guide optimal strategy for treating such infections. Since it remains unclear how to treat~     bacteremia caused by AB, the present study aims to enroll patients at multiple sites with~     extensively drug resistant Acinetobacter species bacteremia receiving different combination~     therapy to assess treatment outcomes and analyze risk factors associated with mortality.~   "
156994|NCT01511211|"~     This is a Randomized Double blinded controlled trial on the effect of adding dexamethasone to~     Ropivacaine on the duration of pain relief for ultrasound guided femoral, obturator and~     popliteal block after total knee replacement surgery.~   "
156995|NCT01511198|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     determine the dose-response relationship for body weight and five escalating doses of NNC~     90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral~     hypoglycemic agent (OHA).~   "
156996|NCT01511185|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose~     concentrations in subjects with type 2 diabetes.~   "
156997|NCT01511172|"~     This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect~     on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin~     given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic~     agents).~   "
156998|NCT01511159|"~     This trial is conducted in Europe. The aim of this trial is to determine the relative~     bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when~     injected under the skin.~   "
156999|NCT01511146|"~     The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good~     options in patients with liver metastases. If the patients have colorectal cancer and never~     had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If~     the patient is K-RAS wild type the investigators will add cetuximab. In patients who had~     received oxaliplatin or in patients with other cancers the investigators will use mitomycin~     and gemcitabine together with capecitabine.~   "
157000|NCT01511133|"~     This study aims to test the clinical samples (stool and serum) previously collected during~     clinical development of HRV vaccine, to identify if there is any evidence of PCV-1~     replication and/or immune response to the PCV-1 in vaccinated infants.~   "
157001|NCT01511120|"~     The impact on fluid loading after cardiac surgery by use of two different priming solution~      Fluid overloading with oedema formation is a regular finding following on-pump cardiac~     surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been~     reported to impair both systolic and diastolic function. An association between~     intraoperative fluid loading and postoperative adverse outcome has been demonstrated in~     cardiac patients.~      The investigators have experience with the use of both colloides and combination fluids~     (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the~     investigators used colloides as an additive to the CPB-prime. The investigators observed~     reduced fluid leakage and less total tissue water in several organs.~      The planned study includes patients scheduled for coronary artery bypass, and who have no~     co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated~     Ringer`s solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and~     diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume~     (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be~     monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.~   "
157002|NCT01511107|"~     The investigators will study whether, in young children with acute otitis media (AOM),~     shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance~     provides satisfactory clinical outcome. This is a Phase 2b multicenter, randomized,~     double-blind, placebo-controlled clinical trial in 600 children aged 6 through 23 months~     comparing the efficacy of consistent reduced-duration antimicrobial treatment (5 days) with~     that of consistent standard-duration treatment (10 days) for each episode of AOM developing~     during a single respiratory season (October 1 through May 31).~   "
173834|NCT01289730|"~     The study has the aim to investigate the efficacy and safety of etanercept in patients with~     active undifferentiated spondyloarthritis (uSpA) over the period of 520 weeks.~   "
157006|NCT01511055|"~     Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete~     surgical resection, also known as a R0 resection. At present, the ability to perform a~     complete resection with negative margins is limited by the surgeon's ability to palpate and~     visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and~     costs while maintaining or improving surgical and oncologic outcomes, the investigators must~     develop technologies that improve visualization of the primary tumor and occult metastases,~     real time, during surgery. Recent research has demonstrated that the use of fluorescent~     probes that recognize cancer specific antigens can be used for this purpose when visualized~     using a prototype near-infrared multispectral imaging system.~      This investigation will determine if folate-FITC, a fluorescent probe that recognizes the~     folate receptor (present in > 90% of ovarian cancers) can facilitate surgical resection and~     detect tumor nodules not visible to the naked eye.~   "
157007|NCT01511042|"~     The investigators are very excited that the National Institutes of Health are sponsoring us~     to investigate why patients with diabetes are more likely to develop high blood pressure,~     atherosclerosis (hardening of the arteries), and heart disease. There are two parts of our~     research program. The first part is a screening visit. At this visit you will be given a~     brief physical exam and will be asked questions concerning your medical history. During the~     same visit you will have your blood drawn for routine screening and to prepare DNA for~     genetic testing. You will also be asked to collect a urine sample for routine screening.~      If the doctor finds that you are a healthy candidate you will be invited to participate in~     the second part of the study. During Phase II the investigators will perform physiologic~     tests after you are placed on a low salt diet and again after you are placed on a high salt~     diet. All of the food that you will eat during the two diets will be provided to you by the~     hospital. If you are on blood pressure medication, it may be necessary to discontinue taking~     your present medication for up to three months before beginning the study. Patients~     discontinuing their current blood pressure medication may be placed on a different blood~     pressure medication during this washout period if necessary to maintain blood pressure at~     pre-study levels. The investigators will take you off all medications, except cholesterol~     medications two weeks prior to your scheduled in-patient study. However, if you are currently~     on medication to control your diabetes you will remain on this throughout the entire study.~      Once your blood pressure medications are discontinued, you will be closely monitored to make~     sure you do not encounter any difficulty. If you do not own a home blood pressure monitor,~     the investigators will provide one for to use during the study so that you can keep a daily~     record of your blood pressure readings. The investigators will ask you to call us every three~     days to report your blood pressure readings. Less than 20% of patients with hypertension have~     any significant increase in their blood pressure during this short time off therapy. After~     you have been off your medication for nine days the dieticians will give you low salt meals~     to eat at home for six days. On the sixth day of the low salt diet, you will be asked to~     begin a 24-hour urine collection. You will also be required to come to the Ambulatory~     Clinical Center (221 Longwood Ave.) for a one-hour test. You will return that evening to the~     inpatient Clinical Research Center where you will be admitted for your first study that will~     occur the next morning. On the morning of your low salt study you will have three naturally~     occurring hormones administered and blood samples drawn from an intravenous needle. The~     investigators will also take ultrasound pictures of your heart to see how salt and hormones~     affect the way the heart functions. These tests will last approximately five hours and you~     will be discharged around 12:00 p.m. The dieticians will then give you your meals for the~     next week to take home. Each of these meals will have a high salt content. After six days of~     your high salt diet, on the morning of your second admission to the hospital, you will be~     asked to begin a final 24-hour urine collection. The same study that was done for the low~     salt study will be repeated for the high salt study. You will be discharged around 3:00 p.m.~     This study will determine if you are salt-sensitive. A high salt diet has been found to lead~     to higher blood pressure and weight gain. In addition, the investigators hope to learn more~     about the hormones that regulate your blood pressure and the genes responsible for regulating~     those hormones.~      You will be placed back on your initial blood pressure medication (if you are on any) and~     returned to your regular physician for care. The investigators will provide clinically~     relevant information to you and your physician.~   "
157008|NCT01511029|"~     To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to~     healthy volunteers.~   "
157009|NCT01511016|"~     HIV lipodystrophy syndrome (HLS) is characterized by loss of fat in the arms and legs, with~     increase in fat in the abdomen, and abnormal blood lipid levels. Persons with HLS have high~     risk for cardiovascular disease and diabetes mellitus and the metabolic syndrome. The~     investigators have previously shown that the abnormal lipid levels and lipodystrophy in HLS~     are associated with defective regulation of lipid metabolic rates, specifically, accelerated~     lipolysis (breakdown of stored fats), and decreased fat oxidation (utilization of fats for~     energy). Patients with HLS also have low levels of the hormone leptin. The investigators~     hypothesize that treatment of these patients with leptin will improve fat oxidation and may~     slow the rate of lipolysis. Hence, the investigators propose to study the effect of leptin~     therapy on lipid metabolic rates and lipid and glucose levels in adults with HLS. The~     investigators will use state of the art stable isotope tracer techniques and gas~     chromatography mass spectrometry (GCMS) to measure lipolysis, fat oxidation, and fat~     re-esterification in adipose tissues and liver.~   "
157010|NCT01511003|"~     This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis~     patients who showed unsuccessful response to existing DMARDs.~   "
157011|NCT01510990|"~     When considering 1st line gefitinib treatment for NSCLC, the investigators need epidermal~     growth factor receptor (EGFR) mutational status of the tumor. But most patients do not give~     us such information at the time of diagnosis, because it requires tumor tissue and some time~     period for EGFR examination. So, investigators develop a protocol of 1st line gefitinib~     treatment for NSCLC according to FDG-PET response. If a patient shows 20% or more decrease of~     peak standard uptake value (SUV) after 1 week's gefitinib treatment, he or she will be~     continued the treatment. If a patient shows less than 20% decrease of SUV, he or she will be~     switched to other chemotherapy.~   "
157012|NCT01510977|"~     Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper~     colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate~     bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well~     as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due to~     bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with~     liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic~     antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second~     colonoscopy can be performed with either adding a colon cleansing solution immediately, or it~     can be performed after a few days with colon cleansing agent together with prokinetics. These~     different kinds of bowel preparations after first colonoscopy failure have not been compared.~   "
157013|NCT01510964|"~     The main aim of the study is to assess if a pre consultation intervention facilitates greater~     participation of patients (and accompanying key persons when present) in the consultation~     process by determining an increase in questioning and/or in the number of different illness~     related issues (e.g. diagnosis, treatment, prognosis) being discussed with the oncologist.~      Other aims are to assess the effect of the intervention on the oncologist's level of patient~     involvement, on patient satisfaction and coping and to explore the role of key persons~     accompanying the patient.~      The investigators expect that patients who have the opportunity to rehearse their informative~     needs before the consultation will ask a greater number of questions which in turn will~     determine their greater involvement by the physician and a greater number of satisfied needs.~     The investigators expect also that the straightforward use of a list of printed questions of~     potential relevance for cancer patients and their companions at an early stage of illness, by~     modifying the process of information exchange, increases their participation and satisfaction~     with the consultation, with potential benefits for treatment adherence and consequently~     treatment efficacy.~   "
157014|NCT01510951|"~     The purpose of this study is to assess the safety, tolerability, immunogenicity, and clinical~     effects of AMG 811 following single subcutaneous dose administration in subjects with~     moderate to severe psoriasis.~   "
157015|NCT01510938|"~     The purpose of this study is to assess the potential of probiotics in prevention of~     respiratory tract infections and their complications in children~   "
157016|NCT01510912|"~     The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the~     treatment of osteoarthritis pain of the knee or hip.~   "
157017|NCT01510899|"~     This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and~     safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single~     dose of RO4917838.~   "
157018|NCT01510886|"~     The main objectives of this study are to describe medical professionals responsible of the~     management of patients with MDD in a representative region of Andalusia (in terms of type of~     sites managing the disease, and referral to SC criteria); Describe MDD patient~     characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated~     to a higher incidence of referral from PC to SC.~   "
157099|NCT01509794|"~     As simulation is now used in many post-graduate education and assessment domains, the~     investigators want to learn about how autonomically engaged healthcare providers are with the~     investigators computer simulation paradigm. The investigators are interested in the~     relationship between autonomic arousal (as measured by heart rate variability and galvanic~     skin response), self-report of engagement, and performance in the simulation and cognitive~     debriefing.~   "
157019|NCT01510873|"~     Symptoms of Primary Immune Thrombocytopenic Purpura (pITP), such as spontaneous bruising,~     menorrhagia, mucosal bleeding and other symptoms might significantly affect the HRQOL of pITP~     patients. However, very little evidence exists on HRQOL outcomes in patients diagnosed with~     pITP. The investigators project will aim at providing scientific community solid evidence~     based data on the extent to which HRQOL is compromised and in which specific area.~      The purpose of this study is thus to compare generic Health-related Quality of Life (HRQOL)~     profiles of adult patients with primary Immune Thrombocytopenic Purpura (pITP) with that of a~     matched Italian population control Group.~   "
157020|NCT01510860|"~     The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus~     Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).~   "
157021|NCT01510847|"~     The study hypothesis is that treatment with oral Testosterone according to the study regimen~     will improve glycemic control in T2DM Chinese males in Singapore as indicated by a reduction~     in HbA1c levels at study day 90.~   "
157022|NCT01510834|"~     This project assesses the usability and feasibility of a multi-behavioral computerized,~     tailored intervention (CTI) or expert system delivered via the Internet for veterans with~     Post-Traumatic Stress symptoms. Three behavioral health risk factors, (1) smoking, (2)~     depression, and (3) stress, that are associated with Post-Traumatic Stress Disorder (PTSD),~     are included in the Computerized, Tailored Intervention (CTI) system. The project adapts and~     modifies an existing CTI system built on the Transtheoretical Model of Behavior Change (TTM)~     to make it relevant to a veteran population. The system has been successfully utilized with~     general adult populations. The study utilizes methods that are characteristic of a product~     development project. Each of the four project phases are sequential and build upon the~     results of the previous phase. Phase 1 focuses on the review of current CTI programs on~     smoking cessation, stress management, and depression prevention, and integrating them into a~     multi-behavioral program for application with veterans. Phase 2 includes the development and~     adaptation of text-based feedback messages and multimedia components for smoking cessation,~     stress management, and depression prevention for veterans. Initial testing of the modified~     CTI programs commences in Phase 3. Cognitive and usability testing with veterans are~     performed, and additional modifications to the behavioral modules are made based on the test~     results. Phase 4 focuses on a feasibility study to test the multi-behavioral CTI system with~     veterans online.~   "
157023|NCT01510821|"~     This is a single center prospective study of 30 patients undergoing elective heart bypass~     surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo~     study is to evaluate the function of vein grafts from small tissue samples treated with a~     pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the~     veins in preparation of bypass grafting. It is unknown if different levels of pressure in the~     syringe affect the vein or damage the vein. Small sections of tissue samples which are~     normally discarded will be obtained immediately after retrieval from the leg and before~     grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no~     clinical endpoints in this study, however, clinical information will be obtained from the~     Society of Thoracic Surgeons database and will include demographics, risk factors, and~     perioperative outcomes.~   "
157024|NCT01510808|"~     Orthodontic Treatment will affect the periodontal status of periodontally treated Aggressive~     Periodontitis patients.~   "
157025|NCT01510795|"~     Chronic allograft nephropathy is one of dominant causes of long term kidney transplant~     failure. Its main histological determinant is interstitial fibrosis and tubular atrophy.~     Mechanisms of these changes are multifactorial and are not completely elucidated. Epithelial~     mesenchymal transition (EMT) might be one of the mechanisms. On molecular level role of renin~     angiotensin aldosterone system (RAAS) has been recognized. Recently, mineralocorticoid~     hormone aldosterone has been proposed as a possible direct contributor to the progression of~     renal injury and fibrosis, beside his well known role as a regulator of extracellular fluid~     volume and sodium and potassium balance. In this study the investigators will determine the~     impact of mineralocorticoid receptor antagonist use on progression of chronic scores in~     transplanted kidney over one year. The investigators hypothesis is that spironolactone use in~     kidney transplant patients will slow down progression of chronic histological changes-~     interstitial fibrosis, tubular atrophy and arteriolar hyalinosis.~   "
157026|NCT01510782|"~     To investigate safety and tolerability of BI 655064 in healthy male volunteers following~     intravenous infusion of escalating single doses and following subcutaneous injection.~     Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and~     determination of the bioavailability of subcutaneous injections of BI 655064.~   "
157027|NCT01510769|"~     This study will compare the serum uric acid lowering effects, clinical benefits, and safety~     of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous~     gout.~   "
157028|NCT01510756|"~     This is a Phase 2 trial to evaluate the activity of sorafenib in relapsed or refractory CLL~     patients with an iwCLL-WG indication to receive therapy.~      Sorafenib is an orally active multikinase inhibitor, which targets the RAF/MEK/ERK signaling~     pathway as well as several receptor tyrosine kinases. It is FDA approved for the treatment of~     hepatocellular carcinoma and renal cell carcinoma. Preclinical studies in the investigators~     laboratory demonstrated that sorafenib is cytotoxic to CLL cells.~      The primary objective of the study is to determine the overall response rate of Sorafenib in~     previously treated CLL patients. All patients will receive sorafenib at 400 mg twice daily~     continuously for three months and then assessed for response. Responding patients may elect~     to continue on treatment for an additional 9 months.~   "
157029|NCT01510743|"~     There has been no study comparing the complication rates between internal jugular vein~     catheterization and subclavian vein catheterization when they are performed using sonographic~     view. This prospective study would reveal the sort of complication and its rate.~   "
157030|NCT01510730|"~     The purpose of this study is to determine whether Helicobacter pylori eradication could~     reduce the new tumor development after endoscopic resection of gastric tumor.~   "
157031|NCT01510717|"~     The purpose of this study is to compare the safety and efficacy of an investigational~     multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.~   "
175306|NCT01270490|"~     The purpose of this study is to assess the feasibility and preliminary efficacy of~     interferon-gamma in combination with anidulafungin for the treatment of candidemia~   "
157032|NCT01510704|"~     To assess the efficacy and safety of different doses of APD421 in the prevention of~     post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV.~     Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any~     surgical technique), cholecystectomy (any surgical technique) or other elective surgery~     scheduled to last at least one hour from induction of anaesthesia), requiring at least one~     overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past~     history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use~     for post-operative analgesia.~   "
157033|NCT01510691|"~     Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal~     membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following~     retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment~     modality. In eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen~     saturation. However, little information is available about the oxygenation and the blood flow~     of the retinal vessels after vitroretinal surgery.~      Hypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in turn~     the most important factor for the development of macular edema. It is a major issue to~     improve the oxygen situation and the blood flow of the retina and there are just a few not~     satisfactory procedures available to overcome this problem. However, vitrectomy would be an~     adequate therapy for many of these diseases, and it would be an appreciated side effect of~     the treatment in almost every case.~      To investigate the influence of oxygenation and blood flow of the retina on clinical outcomes~     after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular~     edema following diabetic retinopathy or retinal vein occlusion.~   "
157034|NCT01510678|"~     Examine the effect of three different dietary messages on dietary intake and the health of~     parents and their children.~   "
157035|NCT01510665|"~     This is a prospective, randomized, placebo controlled study with three parallel arms~     examining the effects of magnesium supplementation in the second trimester of pregnancy.~      Recent research has shown that supplemental magnesium can have beneficial effects, especially~     in overweight individuals. Not only do many people have a magnesium deficient diet, there is~     also evidence that magnesium can improve blood sugar levels. Due to the growing concern of~     obesity with pregnancy and its associated complications, such as diabetes and abnormal fetal~     growth, magnesium therapy could have novel and beneficial effects on pregnancy outcomes.~      In this study, 60 overweight and obese pregnant patients in their first trimester will be~     enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg~     elemental Magnesium), group B will receive dietary counseling about following a magnesium~     rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine~     specimens will be collected at three time points during the pregnancy to analyze changes in~     levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal and~     maternal complications of pregnancy will be noted, including maternal weight gain. At~     delivery, patients will have a placental cord blood specimen and placental biopsy collected~     for gene expression patterns and further analysis.~   "
157036|NCT01510652|"~     This investigation is designed with the hypothesis that using a quadripolar left ventricular~     lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve~     Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left~     ventricular leads.~   "
157037|NCT01510639|"~     The purpose of this study is to test the hypothesis that the application of PRP leads to~     faster wound healing, less wound healing disorders, less pain and faster functional recovery~     after subacromial surgery.~   "
157038|NCT01510626|"~     The long-term goal of the investigators study is to develop a better and safer treatment for,~     and to potentially cure patients with single or multiple food allergies. The investigators~     hypothesize that the application of this protocol will allow patients with severe and single~     or multiple food allergies to be safely and rapidly desensitized.~   "
157039|NCT01510613|"~     The aim of the study is to evaluate the safety and efficacy of Pomalidomide and Dexamethasone~     in patients who did not achieve a complete response after initial treatment with both an~     alkylating agent (Melphalan or Cyclophosphamide) and Bortezomib. Patients who received 1~     previous treatment without achieving a complete response (CR), but who could not be treated~     with alkylators and/or Bortezomib due to contraindications, will be included.~   "
157040|NCT01510600|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with high-risk~     neuroblastoma.~   "
157041|NCT01510587|"~     The main goal of this project is to develop, deliver, and assess the efficacy of a~     parent-centered educational program (4-Health) designed to prevent preteen children from~     becoming overweight.~   "
157042|NCT01510574|"~     Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An~     important strategy in the prevention of deaths is the use of uterotonic drugs for PPH~     prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is~     economical, heat stable, has a long shelf-life, and can be taken orally.~      The investigators envisage that the use of self administered misoprostol after home births~     among mothers would be associated with a peri-partum fall in hemoglobin value of over 20%~     (the outcome of a fall of 2g/dl will also be tested in the pilot).~      The objective of the main study will be to assess the effectiveness and safety of antenatal~     administration of misoprostol tablets (600mcg) for self administration immediately following~     home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study~     are to test the integrity of the study protocol, to test the randomization procedure, to~     assess the acceptability of the intervention, to test the logistics of follow-up, to test the~     data collection forms, to validate the quality of life questionnaire in this population and~     to determine the recruitment rate to help study planning.~   "
157043|NCT01510561|"~     90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to~     assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and~     effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are~     then followed weekly for 12 weeks and afterwards for up to 1 year.~   "
157044|NCT01510548|"~     Aims:~      To study the efficacy and safety of adalimumab versus placebo in the treatment of acute disc~     prolapse will be will be compared up to 12 months after the start of study drug treatment.~      Study type:~      A one year,randomized, placebo controlled double blind single center trial.~      Patients and study drug treatment:~      The study population consist of 99 patients with sciatica caused by herniated disc prolapse.~      The study has 3 arms: 33 patients randomized to adalimumab 40mg every week, 33 patients~     randomized to adalimumab 40mg every other week, and 33 patients randomized to placebo. Study~     drug treatment period will be six weeks.~      Methods:~      Clinical evaluation, global assessments and Oswestry Disability Score and visual analog scale~     (VAS) will be used as the evaluation of clinical results with the disc prolapse patients~     confirmed by Magnetic Resonance Imaging. Health related quality of life will be assessed by~     15-D questionnaire. Safety will be evaluated by medical examinations, adverse events (AE)~     collection and laboratory measurements throughout the study period.~   "
157045|NCT01510535|"~     The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once~     versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3~     weeks in the treatment of patients with osteoarthritis of the knee.~   "
157046|NCT01510522|"~     This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare~     the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients~     treated with Glucophage tablets.~   "
157047|NCT01510509|"~     Even though the safety of drug eluting stents has been long established, in roughly 25% o~     patients their implantation is not considered, for specifically clinical reasons (chronic~     anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. A~     considerable percentage of these patients have diabetes mellitus, a well known risk factor~     for stent thrombosis. Recently, the special characteristics of the titanium stent with nitric~     oxide have been described, causing it to be considered as a bioactive stent.~      The TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled~     clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal~     stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug~     eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic patients~     undergoing percutaneous coronary intervention.~   "
157048|NCT01510496|"~     The treatment of postoperative pain continues to be inadequate in the investigators practice~     setting.~      Inadequate pain treatment not only contributes to postoperative complications in the short~     term but can also be a factor that favors the development of chronic postoperative pain and~     diminishes long-term quality of life. Risk factors that can lead to a transition to chronic~     pain need to be analyzed.~   "
157049|NCT01510483|"~     This study will test an 18-month intervention designed to increase physical activity, reduce~     sedentary practices and promote healthy diets or reduce tobacco use and exposure among~     preteens who obtain orthodontic care. Relevance: If successful, this study may inform~     policies that would promote all specialists (orthodontists, physicians, general dentists) to~     deliver brief counseling for diet, physical activity, and tobacco prevention.~   "
157050|NCT01510470|"~     The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site~     maintains the marginal bone level~   "
157051|NCT01510457|"~     The patients are asked to take part in this study because you have chronic pain as a result~     of knee osteoarthritis. This study is done to investigate the pain relieving effects of the~     study drug Savella (milnacipran HCl) for people who experience chronic osteoarthritis pain.~     The purpose of this research is to look at how the study drug can be used to benefit people~     who experience osteoarthritis knee pain. This is a phase IV study done to study the safety~     and effectiveness of the drug. At this point the drug is already approved by the Food and~     Drug Administration for people with fibromyalgia but it has not yet been approved for people~     with knee osteoarthritis.~   "
157052|NCT01510431|"~     Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen~     Crohn's disease patients at participating centers who typically have already demonstrated~     good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and~     in the view of the investigator, would not benefit significantly from other Crohn's therapies~     but would benefit from use of PROCHYMAL.~      The study is not placebo-controlled or randomized.~   "
157053|NCT01510418|"~     The goal of this pilot study is to understand the socialization of adult men with hemophilia~     living in the United States and their quality of life in order to improve comprehensive care~     for persons with congenital bleeding disorders. Studies in Europe suggest that despite~     medical, surgical, and biotechnology advances in care for persons with the congenital~     bleeding disorders hemophilia A and B, men with hemophilia have earlier work disability and~     health-related lower quality of life than men of the same age who do not have hemophilia in~     the general population. Congenital bleeding disorders are known to have medical and~     psychosocial impact not only in school but also in other activities, e.g. participation in~     sports beginning at a young age. The psychosocial impact of living with a congenital bleeding~     disorder has been studied and described in childhood. The support relationships in childhood~     include parents and primary family of origin and these supports are generally considered in~     pediatric comprehensive care models. Support relationships in adulthood have not been well~     described or studied. The role of spouse and significant others (SSO) of PWCBD in health care~     is of interest for the delivery of adult comprehensive care as well as to understand their~     contribution to the health-related quality of life of PWCBD. Additionally, this study seeks~     to learn of the impact of congenital bleeding disorders for the SSO. The study uses~     self-reported medical and social information questionnaires, health-related quality of life~     surveys, and confidential interview. Results of this study may guide how comprehensive care~     and support are provided to adult persons with congenital bleeding disorders by hemophilia~     treatment programs. This study focuses on PWCBD with hemophilia A or B as a model for the~     experience of persons with other congenital bleeding disorders.~   "
157054|NCT01510405|"~     The investigators have characterized in preclinical Non-Small Cell Lung Cancer (NSCLC) models~     the proteomic expression profile associated with exposure to Aurora and Polo-like kinase~     inhibitors. The identification of proteomic expression patterns in patients with NSCLC would~     be an important step in defining the possible role of these agents as potential targeted~     therapies for this clinically important disease. This study proposes to evaluate resected~     non-small cell lung cancer specimens for these proteomic expression profiles.~   "
157055|NCT01510392|"~     The primary goal of the trial is to show that optical coherence tomography (OCT) technology~     can be used to effectively screen for diseases of the eye including glaucoma, macular~     diseases and keratoconus. Glaucoma is a disease that causes permanent vision loss and is~     usually accompanied by increased eye pressure. Macular diseases affect sharp, central vision.~     Keratoconus is a disease that affects the cornea (clear surface covering the colored part of~     the eye).~   "
160359|NCT01467089|"~     The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS)~     and tardive dyskinesia (TD) examinations conducted via live two-way video versus live~     examinations completed in-person~   "
157056|NCT01510379|"~     The effect a ReletexTM device has on postoperative nausea and vomiting when used with~     ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved~     wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to~     decrease nausea and vomiting. The investigators will randomize 100 patients who are having a~     fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or~     Heller Myotomy for achalasia into two groups. A control group will receive scheduled~     ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan~     as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days.~     These patients will also get scheduled ondansetron and phenergan as needed, like the control~     group. The investigators will compare nausea, retching, and the amount of supplemental nausea~     medication used between the two groups. The patients will be provided a diary to document~     their nausea, retching, and medication use.~      The hypothesis of this study is that use of the ReletexTM device will reduce post-operative~     nausea and vomiting, and will reduce post-operative use of anti-emetic medications in~     patients who have undergone foregut surgery.~   "
157057|NCT01510366|"~     Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the~     objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated~     Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).~   "
157058|NCT01510353|"~     The purpose of this study is to examine the impact of using a real time radiation exposure~     monitoring device on the patient and operator radiation exposure during cardiac~     catheterization. The hypothesis of the study is that use of a real time radiation exposure~     monitoring device during cardiac catheterization will decrease both patient and operator~     radiation exposure compared to no use of the monitoring device.~   "
157059|NCT01510340|"~     The purpose of this study is to evaluate the efficacy of an online virtual intervention in~     optimizing adherence to antiretroviral medication intake among Persons Living with HIV~     (PLHIV).~   "
157060|NCT01510327|"~     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™~     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo~     atherosclerotic coronary artery lesions. The lesions are located in vessels that are~     average-sized.~   "
157061|NCT01510314|"~     The clinical symptoms of septic complications (SC) (responsible for the majority of morbidity~     in colorectal surgery) become apparent only 5-7 days after the operation, whereas the~     efficacy of treatment depends on early diagnosis. By detecting such complications early it~     could be possible to reduce their severity, the length of hospitalisation, repeat colostomy~     and the number of readmissions. Our team has shown that C-reactive protein (CRP) > 125 mg/L~     at postoperative day 4 (D4) was a predictor of SC in this context. Procalcitonin (PCT) is a~     marker of sepsis currently used in intensive care, but its use in the follow-up of elective~     surgery, particularly colorectal surgery, has not been fully evaluated.~      The aim of this study is to compare the ability of CRP and PCT to detect SC as early as~     postoperative day 2 (D2) (intra-abdominal or systemic SC, such as those defined by the CDC)~     after elective colorectal surgery.~      Adult patients about to undergo elective colorectal surgery with anastomosis will be included~     once they have given their written informed consent. Levels of CRP and PCT will be measured~     the day before the surgery, then at D1, D2, D3 and D4. The clinical data (temperature,~     recovery of bowel movement, pain, pain on palpation) will be recorded daily. Imaging~     examinations will be performed at the discretion of the surgeon; the only obligation will be~     to perform a contrast-enhanced abdominopelvic CT-scan if CRP at D4 > 125 mg/L with no other~     clinical anomalies. The discriminating ability (measured by the area under the ROC curve) of~     CRP at D2 was 0.653 in our previous study. An improvement of at least 0.1 will be necessary~     to show the superiority of PCT over CRP in clinical terms and with regard to the cost.~   "
157062|NCT01510301|"~     The purpose of this study is to examine if a mobile phone-based self-report system, using the~     patient's own mobile phone, will improve adherence to treatment of hypertension and lead to~     personal involvement of the patient in the treatment.~   "
157063|NCT01510288|"~     Ipilimumab, an antibody that blocks cytotoxic T-lymphocyte antigen 4, and GVAX have~     demonstrated anti-tumor activity in prostate cancer. Pre-clinical studies with this~     combination have demonstrated potent synergy. The purpose of this study is to investigate,~     using a phase-I 3+3 dose escalation design followed by an expansion cohort, the safety and~     efficacy of combined treatment with GVAX and ipilimumab in castration-resistant metastatic~     prostate cancer (CRPC) patients.~   "
157064|NCT01510275|"~     In a rehabilitation setting, respiratory muscle training with re-expansion techniques in~     patients following cardio-thoracic surgery represents a consolidated intervention. New~     devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an~     effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators~     study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent~     history of cardio-thoracic surgery.~   "
157065|NCT01510262|"~     People who present repeatedly at Sexually Transmitted Infection (STI) clinics represent a key~     population for HIV prevention intervention research. Despite their heightened risk there is~     an absence of empirical research on strategies to intervene with repeat STI. Some STI-clinic~     based behavioral HIV prevention studies, focusing on the general STI patient population, have~     found that risk reduction interventions can reduce the incidence of a subsequent STI. Studies~     have shown that expedited treatment for STI patients' partners can reduce subsequent STI and~     enhancing partner notification can reduce risk for repeat infection. Those who go on to~     experience repeat infections, after they are provided with risk reduction services, are the~     focus of this project. Repeat STI literature noted, there have been no intervention studies~     conducted to lower STI/HIV risk specifically among people who are presenting with repeat STI.~      The proposed study develops a risk reduction intervention designed for STI repeaters and~     evaluates the efficacy of this intervention and its cost-effectiveness. The investigators~     expect that the intervention for STI repeaters will be significantly more effective than~     standard care with regard to reducing participants' STI/HIV risks. However, even a~     highly-effective intervention is unlikely to be adopted if the outcomes come at a high cost.~     Administrators need to know how effective a new intervention is, but also if it is more~     cost-effective than the program it replaces.~      Cost-effectiveness information also is critical to justify the new intervention to~     prevention funders (Milwaukee Department of Health), who are concerned not only with costs~     and effects, but also with the tradeoff between them. The proposed study will provide the~     comprehensive level of information about intervention effects and cost-effectiveness required~     by administrators and resource allocation decision makers to determine whether or not to fund~     or implement the intervention.~      Hypothesis 1. The investigators expect a greater reduction in unprotected vaginal and anal~     intercourse in the prevention case management compared to the standard care condition.~      Hypothesis 2. The hypothesis that the case management group will have a lower STI~     re-infection rate compared to the standard care group will be tested using each participant's~     repeat STI status over the 12 month FU period.~   "
157221|NCT01508182|"~     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)~     tablets of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of the FDC tablets (canagliflozin and metformin IR).~   "
157066|NCT01510249|"~     Heel spur is a troublesome disorder. Its formation is accompanied by pain in the area of heel~     and it makes walking limited or even impossible.~      The aim of the study is to analyze analgesic efficacy of ultrasound and shock wave therapy in~     patients with heel spur.~      The study included 52 patients of both sexes, aged 38-86 (average 57.39) with plantar heel~     spur confirmed radiographically. The patients were randomly divided into two groups;in Group~     1 the patients underwent ultrasound procedure (10 treatments)and in Group 2 - radial shock~     wave procedure(6 treatments). The researchers assessed pain three times (prior to the~     therapy, after the first and then the second week of treatment). In order to do this they~     used a modified form of the Laitinen pain indicators questionnaire (results expressed in~     points) and VAS - visual analogue scale (results given in milimeters). The results were~     statistically analyzed. In the studied periods of time a decrease in pain was observed (both~     in the Laitinen questionnaire and in the VAS scale). The most rapid change was noted in both~     the groups after the first week of treatment. Ultrasound and shock wave therapies show a~     comparably significant analgesic efficacy in patients with heel spur. Shock wave therapy has~     an advantage over ultrasound therapy. A smaller number of procedures is required to obtain~     comparable results, which makes the therapy less expensive. No side effects were observed~     during and after the treatment.~   "
157067|NCT01510236|"~     The overall aim is to evaluate the clinical efficacy and cost-effectiveness of a self-help~     program via internet aiming at preventing development and maintenance of cancer-related~     emotional distress among adolescents with cancer.~   "
157068|NCT01510223|"~     This study examined the effect of a 5-day HFD supplemented with specific fatty acids on~     gastrointestinal transit, appetite, food intake and substrate utilization. Another novel~     aspect of this chapter was examining whether a subsequent 5-day period was sufficient to~     reverse the effects of high-fat feeding on the aforementioned parameters.~   "
157069|NCT01510210|"~     The objective of this study is to assess the risk profile in patients with atrial~     fibrillation, which represents the degree of changes in the atrial tissue and which can help~     predict in which patients rhythm control will be successful. This risk profile will consist~     of a combination of underlying (heart) disease and risk factors, measurements obtained from~     echocardiograms, and circulating biomarkers. Ultimately this risk profile can be used to~     guide type of rhythm control therapy in individual patients with atrial fibrillation.~   "
157070|NCT01510197|"~     The objective of this study is to assess the risk profile in patients with atrial~     fibrillation, which represents the degree of changes (remodeling) in the atrial tissue and~     which can help to predict in which patients rhythm control will be successful. This risk~     profile will consist of a combination of underlying (heart) disease and risk factors, as~     measured with use of parameters obtained with echocardiography, circulating biomarkers and~     other relevant clinical data. Ultimately this risk profile can be used to guide type of~     (rhythm) control therapy in individual patients with atrial fibrillation.~   "
157071|NCT01510184|"~     The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with~     observation alone in patients who are in PET-negative complete remission after first-line~     R-CHOP or R-CHOP like therapy.~   "
157072|NCT01510171|"~     The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral~     antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI with~     bivalirudin monotherapy.~   "
157073|NCT01510158|"~     This study that compare the serum uric acid lowering effects, clinical benefits, and safety~     of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who~     have had an inadequate response to allopurinol.~   "
157074|NCT01510145|"~     The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution~     without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic~     solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to~     tolerability issues.~   "
157075|NCT01510132|"~     The purpose of this multi-center, open label, single arm, post-marketing surveillance study~     is to assess the safety of Travacom in patients with open-angle glaucoma or ocular~     hypertension who are insufficiently responsive to beta-blockers, prostaglandins, or other~     intraocular pressure-lowering (IOP) medication and when use of Travacom is considered~     appropriate.~   "
157076|NCT01510119|"~     This is an open labeled phase I dose escalation study of HCQ and RAD001 in patients with~     advanced renal cell carcinoma followed by a Phase II trial of RAD001 with HCQ. The target~     population are patients with one to three prior treatments for advanced renal cell carcinoma.~     In the phase I portion a traditional 3+3 design will be used to determine the maximal~     tolerated dose and/or recommended phase II dose for HCQ in combination with RAD001 po 10~     mg/day.~   "
157077|NCT01510093|"~     This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles~     of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with~     continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous~     glucose infusion. The order of treatment session will be randomised.~      Hypotheses:~        1. Secretion of endogenous insulin depends on exogenous insulin supply~        2. Secretion of endogenous insulin is depends on plasma glucose levels~   "
157078|NCT01510080|"~     In order to meet an existing lack of empirical studies in the field of cognitive behavioral~     therapy supervision, the present randomized controlled trial is aimed at comparing two~     different types of supervision. This study compares computer-assisted live supervision and~     delayed video-based supervision regarding efficacy and acceptance among therapists, patients~     and supervisors. The efficacy of supervision is defined on different levels such as change of~     psychotherapeutic competence, nondisclosure, self-efficacy, self-awareness of the supervisee~     as well as therapeutic alliance, supervisory alliance and therapy outcome.~   "
157079|NCT01510067|"~     The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site~     database between the University of Pennsylvania and the University of Texas Southwestern~     (UTSW).~   "
157080|NCT01510054|"~     MiRNAs are single-stranded small non-coding RNAs that act on specific mRNAs to regulate the~     gene expression. Studies have suggested that miRNAs influence cellular activities in the~     uterus, including cell differentiation and embryo implantation.~      In assisted reproductive cycles, controlled ovarian stimulation (COS) results in~     supraphysiological steroid levels and is associated with very low luteinizing hormone~     concentration during the luteal phase, the peri-implantation and implantation period. Luteal~     phase support, administration of medication aimed at supporting the implantation process, has~     been a routine practice in in vitro fertilization (IVF) clinics. Luteal phase support with~     steroid hormone has been found to improve pregnancy rates when human menopausal gonadotropins~     were used in conjunction with GnRH agonists for ovarian stimulation and IVF. Reports on~     effect of steroid supplementation in GnRH antagonist protocols are limited.~      The proposed project is an extension of our previous study on Endometrial Luteal Phase~     Characteristics and Luteal Phase Support in Controlled Ovarian Hyperstimulation Protocols~     with Gonadotropin Releasing Hormone Antagonists. The significance of this study is based on~     the importance of luteal phase endometrial after COS for the process of implantation. The~     availability of oocycte donors in assisted reproduction technology programs offers a unique~     opportunity to study the impact of different stimulation protocols on the quality of the~     luteal phase. In addition, the oocyte donor model may allow us to evaluate the impact of~     different luteal support protocols directly on the endometrial preparation by histological as~     well as biochemical markers.~      Study design: Study subjects underwent ovarian stimulation according to a gonadotropin/GnRH~     antagonist protocol. All donors had a baseline measurement of serum follicle stimulating~     hormone (FSH) and estradiol levels on the second day of their menstrual cycles. Provided~     serum FSH levels were less than 10mIU/ml and E2 levels were less than 60pg/ml, ovarian~     stimulation was initiated with recombinant FSH. The daily dose was adjusted according to~     follicular development by serial transvaginal ultrasound and serum E2 response. A daily~     evening dose of ganirelix acetate was initiated on the 6th day of stimulation and continued~     through the day of human chorionic gonadotropin administration. When at least three follicles~     reached a mean diameter of 18mm, ovulation was triggered with a single dose of Human~     chorionic gonadotropin (hCG). Sonographically guided transvaginal oocyte retrieval was~     performed 34-36 hours after the hCG administration.~      Thirty endometrial biopsies from oocyte donors on their COS cycles will be used for the~     study. Study subjects have been randomized into 4 groups. Grp 1: day of retrieval, did not~     receive any luteal-phase support, which serves as base line; grp2: 3, 5 and 10 days after~     retrieval with no luteal phase support, which serves as control; grp3: 3, 5 and 10 days after~     retrieval, luteal phase support with progesterone in the form of vaginal suppositories~     starting from the day after retrieval; grp4: daily oral dose of 2 mg 17β-estradiol in~     addition to the micronized progesterone. Immediately after the endometrial biopsy all~     specimens were stored in liquid nitrogen tanks at -196°C.~      Total RNA will be isolated and microarray will be performed using an Illumina miRNA~     expression panel. Array results will be compiled and analyzed focusing on the following~     aspects: the target genes of prominent miRNAs, miRNA profile in relation to target gene~     pathways; miRNA expression profile in relation to endometrial dating and status; effect of~     luteal phase support on miRNA expression after ovarian stimulation. Minimum of 3 miRNA arrays~     will be run for each sample for the purpose of statistical analysis. A total of 30 arrays~     will be needed for all samples from all groups.~      In this study, the investigators pose three questions: 1) How many and what types of miRNAs~     are in the endometrium during ovarian stimulation? This is to identify miRNAs and associated~     target genes that are relevant for endometrium receptivity; 2) Do levels of miRNA expression~     change during the luteal phase, or during the window of implantation? This is to examine the~     dynamics of miRNAs that are associated with remodeling process of endometrium; and 3) Do~     luteal phase support alter miRNA expression in the luteal phase? This is to investigate the~     steroid effect on miRNA regulation. The investigators hypothesize that many critical genes~     related to implantation are regulated by miRNAs. This research effort will potentially~     advance our knowledge of endometrial characteristics after COS and the impact of sex steroid~     supplementation. Overall the study should help better understand the genetic control of~     implantation. Completion of this study may also provide measurable scientific evidence and~     useful information for the management of IVF cycles.~   "
157100|NCT01509781|"~     The objective of this prospective randomized study is to perform qualitative and quantitative~     comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus~     the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex~     mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum~     from wound cavity, the extent of early postoperative analgesic requirements and quality of~     life.~   "
157081|NCT01510041|"~     In patients with chronic obstructive pulmonary disease (COPD) breaths at an abnormally high~     lung volume causes the inspiratory muscle to operate at non-optimal lengths, which reduce~     their maximal contractile forces. In addition, causes non thoraco abdominal synchronize,~     reduced inspiratory muscle strength and is associated with dyspnea and decreased exercise~     capacity. For these patients inspiratory muscle training (IMT) is a widely employed form of~     rehabilitation also targeting the respiratory muscle. In addition, patients often experience~     shortness of breath and a decline in exercise tolerance, resulting in disability in the~     performance of activities of daily living (ADL). The aims of this trial are to evaluate the~     effects of inspiratory muscle training associated with aerobic training on strength and~     endurance of inspiratory muscle, thoracic abdominal synchrony, exercise tolerance and quality~     of life patients with COPD. To compare the responses with the effects of aerobic training~     plus exercises of the trunk and upper limbs, and stretching of large muscle groups of the~     trunk. To compare difference in the perception of dyspnea during the ADL set (Borg Scale)~     with perception of dyspnea self-reported in the Medical Research Council (MRC), the London~     Chest Activity of Daily Living (LCADL) and the Pulmonary Functional Status and Dyspnea~     Questionnaire - Modified version (PFSDQ-M) before start the protocol. To investigate changes~     on perception of dyspnea (Borg scale), metabolic and ventilatory responses during a standard~     set of ADL tasks after a physical training and to evaluate and compare changes on perception~     of dyspnea. The hypothesis are that the ventilatory efficiency during the performance of ADL~     and the dyspnea reported from borg scale, the LCADL and the PFSDQ-M that quantifies the~     functional performance (change in activity levels) are improved during the IMT in conjunction~     with general exercise training in patients with COPD. The MIT increases the strength and~     endurance of inspiratory muscle, the exercise capacity and the quality of life compared to~     the general physical training. However, compared to the thorax abdominal synchronizes, higher~     modification is verified in the general physical training group with specific exercise to~     torso, limbs and stretching of the higher muscle group.~   "
157082|NCT01510028|"~     The purpose of this study is to determine the safety of ascending doses of HGT-1110~     administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with~     metachromatic leukodystrophy (MLD).~   "
157083|NCT01510015|"~     This study evaluates the effects of psychological and pharmacological treatment of regular~     users of cannabis and psychostimulants in a treatment center (Kfar Izun) in Israel. The~     participants will undergo psychological evaluation before and during treatment and follow up~     at 4 months. Ten participants will undergo brain imaging of the dopamine receptor D2 in order~     to evaluate the effects of treatment on dopamine turnover in the brain. A control group of~     psychiatric in-patients undergoing treatment for psychiatric illness with be recruited from~     Geha Hospital in Israel. It is predicted that successful treatment of regular users of~     cannabis will be resulted in improvement in anxiety, depression and psychotic symptoms as~     well as in upregulation of dopamine turnover in participants that will undergo brain imaging.~   "
157084|NCT01510002|"~     The purpose of this study is to determine whether prophylactic central neck dissection is~     beneficial for patients with papillary thyroid cancer staged preoperatively as node negative.~   "
157085|NCT01509989|"~     The treatment of systemic lupus erythematosus (SLE) may change in the future due to the~     availability of new biological treatments, especially monoclonal antibodies in patients with~     active disease. However, one of the main causes of treatment failure in SLE is the lack of~     treatment adherence since drugs don't work in patients who don't take them.~     Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and~     investigators have demonstrated that patients who do not take HCQ for a long time have~     undetectable or very-low blood HCQ concentrations (< 200 ng/ml). The rate of severe~     non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active~     disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients~     with a SLEDAI ≥12.~      Investigators will evaluate the importance of non-adherence to the treatment in a large~     population of SLE patients with active disease. This will be done with blood HCQ monitoring~     in a translational multicentric prospective study.~   "
157086|NCT01509976|"~     Triclosan (5-chloro-2 (22,4-dichlorophenoxy)phenol) is a broad-spectrum antibacterial and~     antifungal agent that is found in thousands of common household products, including~     deodorants, toothpaste, antibacterial soaps, cleaning products, kitchen utensils, bedding,~     socks, trash bags. The benefits of triclosan have not been proven except in reducing plaque~     and gingivitis when used in toothpaste. In this study, the investigators intend to look at~     whether exposure to triclosan changes the colonizing flora of the skin, gut and mouth as well~     as changes in certain blood hormone levels, including adipocytokines, androgens, and~     inflammatory markers. Changes in the gut microbiota have been associated with a variety of~     disease states such as inflammatory bowel disease, colorectal cancer. Additionally,~     reductions in the microbiome diversity have been associated with obesity.~   "
157087|NCT01509963|"~     The purpose of this study is to prospectively evaluate the combined use of the MSKCC nomogram~     (Memorial Sloan-Kettering Cancer Center) and Tenon score to select, in patients with~     metastatic sentinel lymph node (SN), those at low risk of metastatic non-SN in whom~     additional axillary lymph node dissection (ALND) could be avoided.~   "
157088|NCT01509950|"~     Currently different materials are used to close the skin after a cesarean delivery, including~     absorbable suture, non-absorbable suture and staples. It is not known what is the best choice~     of material to close the skin after a cesarean section, but commonly staples or dissolvable~     suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a~     better cosmetic outcome than staples. The investigators hope to learn if there is a~     difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene~     suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also plan to~     look for differences in wound complications and patient satisfaction, as well as operating~     and removal times. This knowledge will be important in helping practitioners choose the~     closure technique at cesarean delivery.~   "
157101|NCT01509768|"~     The purpose of this study is to evaluate the natural course of disease progression in~     Mucopolysaccharidosis Type III (MPS IIIB) patients who are untreated to identify potential~     surrogate endpoints that may be utilized in future treatment trials of MPS IIIB using~     predefined assessments including standardized clinical, biochemical, neurocognitive,~     developmental, and imaging measures.~   "
157102|NCT01509755|"~     This trial is conducted in Europe. The aim of this trial is to establish the dose response~     relationship on glycaemic control of five dose levels of NNC90-1170.~   "
157103|NCT01509742|"~     This trial is conducted in Europe. The aim of this trial is to examine the effect of NNC~     90-1170 on the hypoglycaemic counterregulation in subjects with type 2 diabetes.~   "
157104|NCT01509729|"~     Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic~     treatment.~   "
157222|NCT01508169|"~     The objective of this study was to determine if foot orthoses are effective in improving~     balance, pain and disability in elderly women with osteoporosis.~   "
157223|NCT01508156|"~     The purpose of the study is to test the safety and tolerability of different doses of IDX719~     to find the best dose for future studies. The study will also assess the pharmacokinetics of~     IDX719. No formal hypotheses will be tested.~   "
157089|NCT01509937|"~     It is hypothesized that bioimpedance spectroscope guided fluid management will help patient~     reach euvolemic status, and increase long term survival.~      Background: Bioimpedance analysis (BIA) was helpful in identifying hypervolemia.~     Observational data using BIA methods showed that hypervolemic patients on maintenance~     hemodialysis (MHD) suffered from high mortality risk. But it is not clear if BIA guided fluid~     management can improve MHD patients' survival. The objectives of the BOCOMO study are to~     evaluate the outcome of BIA guided fluid management comparing with standard care.~      Design: This is a multicenter, prospective, randomized, controlled trial. Setting and~     Participants: More than 1300 participants from 16 clinical sites will be included in the~     study. The enrollment period will last 6 months, and minimum length of follow-up will not~     less than 36 months. MHD patients aged more than 18 years but less than 80 years who had been~     on MHD for at least 3 months and considered suitable candidates will be invited to~     participate in the study. Participants will be randomized to BIA arm or control arm using 1:1~     ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D~     GmbH) will be used for BIA measurement at baseline for both arm, and every 2 months in BCM~     arm.~      Predictors: BCM guided fluid management and fluid management using standard care.~      Outcome and measurements: The primary intent-to-treat analysis compares composite endpoint~     between BCM arm and control arm. The secondary intent-to-treat analysis compares left~     ventricular thickness, blood pressure, medication, and incidence and length of~     hospitalization between BCM arm and control arm. Death, acute myocardial infarction, stroke,~     peripheral arterial disease will be used as composite endpoint.~   "
157090|NCT01509924|"~     The purpose of this study is to determine whether Physical Activation on Prescription can~     help patients with TIA to become more physically active.~      One group will receives Physical Activation on Prescription (PaP)and the other group will~     receives usual care.~      And to identify if persons with TIA presents with cognitive impairments.~   "
157091|NCT01509911|"~     TL-118 is an anti-angiogenic drug combination designed for the treatment of cancer. The~     investigational product Tl-118 comprises of four well-known active components. The therapy is~     administrated at a unique dosing regimen that was found to be effective and advantageous in~     terms of safety. The product is formulated as an oral suspension, conveniently administrated~     by the patients at home and not requiring medical staff assistance. This Phase II clinical~     trial aims to evaluate the efficacy, safety and tolerability of TL-118 in Gemcitabine treated~     Pancreatic Cancer patients~   "
157092|NCT01509898|"~     The aim of this study was to evaluate the effect of a dental water jet on initial~     peri-implant disease resolution.~   "
157093|NCT01509885|"~     The main goal of this research is to understand the neuronal mechanisms that mediate the~     development of spasticity and motor dysfunction after spinal cord injury. The investigators~     examine how neurons and neuronal circuits in an injured nervous system adapt to produce the~     uncontrolled and unwanted muscle contractions that affect the majority (80%) of patients with~     spinal cord injury. One of the neurons that the investigators study is the motoneuron that~     excites the muscles of the limbs to produce movement. Previously, the investigators have~     shown that after spinal cord injury, the excessive and uncontrolled activity of motoneurons~     during muscle spasms is mediated, in large part, by the activation of calcium currents in the~     human motoneuron. In human patients the investigators have used recordings from single muscle~     fibres to estimate the contribution of these calcium currents in activating the motoneuron~     during muscle spasms. In this proposal, the investigators study why motoneurons recover these~     calcium currents and self-sustained activity after chronic spinal cord injury. Because the~     calcium currents require the presence of the monoamine serotonin (5HT) to activate, and this~     monoamine is greatly reduced after injury, the investigators examine if the calcium currents~     recover because the 5HT receptors become spontaneously active without the need for 5HT to~     bind to the receptor, which the investigators hypothesize to be one of the causes of~     spasticity after spinal cord injury. This research will pave the way to develop new~     pharmacological and rehabilitative therapies to both control spasticity after spinal cord~     injury and augment residual motor movements.~   "
157094|NCT01509872|"~     The investigators are interested in knowing whether a group-based, trauma-focused~     intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non~     trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic~     stress, depression and anxiety and conduct problems and increasing pro-social behavior among~     war-affected children in the Democratic Republic of Congo.~   "
157095|NCT01509859|"~     The purpose of the study is to Compare the stability of the fracture and pain after surgery~     by measuring the stride length and weight bearing on the operated leg. This study will~     compare these parameters between two different proximal femur nails used for fixing hip~     fractures.~   "
157096|NCT01509846|"~     This is a research study about an experimental (investigational) oral inactivated whole cell~     Shigella flexneri 2a killed vaccine (Sf2aWC). Sf2aWC is a killed vaccine that is being made~     to prevent disease from Shigella., which causes bloody, watery diarrhea. Infants and children~     living in developing countries experience the greatest consequences of this disease. The~     purpose of this study is to find a dose of the vaccine that is safe, tolerable, and develops~     an immune response. About 82 healthy adults, ages 18-45, will participate in this study. This~     study will require volunteers to stay in the research facility for several nights for the~     first dose. Participants in Cohorts 2, 3, and 4 will not be required to stay overnight for~     the second and third doses. Participants will be assigned to receive 1 of 4 vaccine doses by~     mouth. Study procedures include: stool samples, blood samples and documenting side effects.~     Participants will be involved in study related procedures for about 8 months.~   "
157097|NCT01509833|"~     This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of~     the late follicular phase administration of low dose hCG on oocyte maturity for ovarian~     stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI)~     treatment.~   "
157098|NCT01509807|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     injectable suspension) to determine if total opioid consumption is reduced when using~     EXPAREL, therefore possibly reducing total hospitalization costs.~   "
157153|NCT01509092|"~     The purpose of this study is to compare the anatomical and visual recovery of eyes with~     traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.~   "
157105|NCT01509716|"~     Aims: The investigators' primary objective is to assess both perceived and actual disease~     knowledge in local pre-dialysis Chronic Kidney Disease (CKD) patients. The investigators~     hypothesize that actual disease knowledge is poorer than perceived. As the secondary~     objectives, the investigators will also assess the HRQoL and examine the association between~     level of knowledge and HRQoL in pre-dialysis CKD patients. The investigators hypothesize that~     HRQoL of pre-dialysis CKD patients is poorer than that of the general population while~     pre-dialysis CKD patients with greater disease knowledge have a better HRQoL than those with~     poorer knowledge.~      Methodology: A survey was developed to assess both perceived and actual knowledge on five~     aspects - general knowledge, nephrotoxic medications, diet restrictions, symptoms of CKD and~     its complications and renal replacement therapy (RRT) options. For the assessment of HRQoL,~     the following questionnaires will be used - Kidney Disease Quality of Life-Short Form~     (KDQOL-SF) version 1.3, EuroQoL 5 Dimensions (EQ-5D), Family Functioning Measure (FFM), and~     Oslo-3 Social Support Scale (OSS-3). All study questionnaires will be provided in 3 main~     languages - English, Chinese and Malay. A standardized data collection form was developed to~     retrospectively collect demographic and clinical information from the patients' electronic~     medical records and patient charts. Descriptive statistics will be used to report all~     results.~   "
157106|NCT01509703|"~     The aim of this study is to gain knowledge about effects of high flow transnasal insufflation~     on various breathing parameters like intratracheal pressure conditions, CO2 elimination,~     breathing frequency and tidal volume.~   "
157107|NCT01509690|"~     Patients with end-stage renal disease are most vulnerable in the early months following~     hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore~     Renal Registry showed high mortality rates in the first 3-12 months of dialysis.~     Comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months~     of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the~     United States.~      Based on these models, the Hemodialysis Initiation and Transition (HIT) Clinic involving a~     renal physician, clinical pharmacist and coordinator was set up. The main aim of the clinic~     is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to~     4 months after HD initiation to focus on and streamline the management of dialysis issues and~     complications. These interventions would help patients achieve goal therapeutic targets, as~     well as reduce hospitalization rates and mortality, thereby improving their clinical outcomes~     and self-reported quality of life, and could result in economic and cost savings for the~     patients and healthcare system. The purpose of this study is to determine if the~     multidisciplinary, intensive and collaborative management of our multiethnic Asian patients~     newly-initiated on HD improves laboratory, clinical, economic and patient-reported outcomes.~      Adult incident HD patients from NUH will be randomized to the HIT clinic or to conventional~     management. Information on demographics, medical/medication histories, laboratory data~     (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and~     diabetes), hospitalizations, deaths and medical costs will be obtained and compared between~     the 2 groups. Patient-reported outcomes will be measured using the Kidney Disease Quality of~     Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support~     Scale and Health Services Utilization questionnaires. Data collection will take place at~     baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and~     follow-up period of 1 year.~   "
157108|NCT01509677|"~     The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets~     once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and~     additional in sputum and blood serum. Also data on safety status will be obtained.~      Patients to be included required to have moderate to severe COPD associated with chronic~     bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks~     maximum.~   "
157109|NCT01509664|"~     The investigators plan to test the effect of price reduction of fruits and vegetables and~     non-caloric beverages on food purchasing, food intake, body weight, and body composition of~     primarily single adult shoppers. One hundred subjects will be randomized to an experimental~     or control group for a 4 month period. In the experimental group, there will be an automated~     50% reduction in fruits vegetables and non-caloric beverages during the middle 2-month~     period. The investigators expect to observe significant changes in food shopping and eating~     behavior during this period, which should lead to body weight and fat loss. Some of these new~     shopping patterns should persist in the last month of the study even though prices revert.~   "
157110|NCT01509651|"~     Although anticholinesterase reversal agents have been used in combination with~     anticholinergic drugs for over half a century, it has been suggested that they should be used~     with caution in patients with underlying cardiovascular disease. As sugammadex has no~     endogenous targets, it is unlikely to cause any adverse cardiovascular effects. This~     selective relaxant binding agent is specifically designed to encapsulate rocuronium, which~     can, therefore, promptly restore neuromuscular function regardless of any levels of NMB as~     the dose is increased.~      Some reports, however, suggest that sugammadex may have increased time to effect in some~     patient populations like the elderly, patients in intensive care and renal failure patients.~     A less dynamic circulation and increased transfer time to the effector site in these subjects~     are likely explanations for this effect. The present trial was designed to assess the safety~     and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced NMB in patients~     with heart failure.~   "
157111|NCT01509638|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     injectable suspension) to determine if total opioid consumption is reduced when using~     EXPAREL, therefore possibly reducing total hospitalization costs.~   "
157112|NCT01509625|"~     This retrospective observational study is designed to assess the response to treatment with~     fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of~     progression free survival (PFS), overall survival (OS), and clinical benefit rate (CBR), in~     post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were~     treated with this medicinal product and at said dose after having progressed with a previous~     anti-estrogen therapy. During this study, a retrospective data collection will be carried out~     using the information contained in the Clinical History of said patients, provided that the~     treatment with fulvestrant at a dose of 500 mg and LD-500.~   "
157113|NCT01509612|"~     The investigators aim to investigate the validity of their previous results in a randomized~     prospective, placebo-controlled, double-blind, multicenter controlled evaluation of~     questionnaires in patients with advanced malignant tumors. The investigators plan to compare~     the treatment outcome (quality of life and survival) in tumor patients, receiving standard or~     add-on homeopathic treatment.~      The null hypothesis is that add-on homeopathic treatment does not create a benefit for~     cancer patients. In addition the investigators evaluate survival time.~   "
157154|NCT01509079|"~     The Purpose of this study is to determine whether vitamin D3 supplements will decrease the~     muscle and bone pain that are reported by women who take Aromatase Inhibitors.~   "
157114|NCT01509599|"~     Leg vein circulation problems can damage the skin of the lower legs, especially around the~     ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop.~     Inflammation is often present in the damaged skin. This study will test whether using a~     special low compression, cooling, boot-like gel wrap placed around the damaged skin of the~     lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is:~     A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation,~     compression stockings) intervention compared to a low compression non-cryotherapy sham wrap~     (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of~     venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5~     venous insufficiency.~   "
157115|NCT01509586|"~     This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers~     who are not motivated to quit to test the effects of a marketed oral, non-combustible~     smokeless tobacco product on cigarette smoking behaviors. It will also track the~     participants' usage patterns of the smokeless tobacco product.~      Half of the participants will receive a new, potentially safer tobacco product during the~     first six weeks of the study, and half will not. During this six-week period, each~     participant will complete three brief phone interviews. After this first six week period,~     participants will complete 6 other brief follow-up interviews, where they will answer~     questionnaires about their smoking habits.~   "
157116|NCT01509573|"~     The research will examine the following Specific Aims:~      Specific Aim 1: To adapt a U.S.-developed family-focused and strengths-based prevention~     program to the context of HIV/AIDS-affected families in Rwanda (the Family-Strengthening~     Intervention in Rwanda or FSI-R) using prior qualitative findings and CAB input.~      Specific Aim 2: To deliver the intervention to a small group of families to collect~     preliminary data on intervention feasibility, acceptability, and to further refine the~     intervention manual for the FSI-R.~      Specific Aim 3: To conduct a pilot feasibility study of the FSI-R with 80 families.~      In pursuit of Specific Aim 3, this research will (a) conduct a preliminary exploratory~     analysis to examine the extent to which the FSI-R for HIV/AIDS-affected families is~     associated with improved caregiver-child relationships using measures of family~     connectedness, good parenting, and social support. Hypothesis 1: Participants in the FSI-R~     will demonstrate increases in protective processes compared to usual care controls not~     exposed to the FSI-R. It will also (b) conduct a preliminary exploratory analysis to~     determine the extent to which improved caregiver-child relationships are sustained four~     months after the conclusion of the FSI-R. Hypothesis 2: Four months after the conclusion of~     the intervention, participants in the FSI-R will demonstrate increases in protective~     processes compared to usual care controls not exposed to the FSI-R.~   "
157117|NCT01509560|"~     In this prospective study is to examine whether the use of everolimus in patients after~     allogeneic SCT as part of GVHD prophylaxis for a further review in clinical studies is~     appropriate.~   "
157118|NCT01509547|"~     This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21.~     After assessment and inclusion into the study, participants will be randomized to receive a~     12-week double blind course of varenicline or placebo.~   "
157119|NCT01509534|"~     Study hypothesis: Dual-chamber pacemaker therapy with rate-hysteresis features is effective~     in preventing syncopal recurrences in patients affected by cardioinhibitory (CI) forms of~     reflex syncope diagnosed by means of carotid sinus massage, tilt table testing or implantable~     loop recorder (ILR). The outcome is measured either by the time to first syncopal recurrence~     or the total syncope burden.~   "
157120|NCT01509521|"~     The purpose of this study is to determine the impact of phenylephrine versus ephedrine on~     organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The~     organ perfusion is estimated by measuring the maternal cerebral oxygenation by~     NIRS(Near-infrared spectroscopy)and the foetal heartrate.~   "
157121|NCT01509508|"~     This trial is evaluating a public health intervention strategy trial which aims to reduce the~     incidence of HIV at a population-level.~      The proposed strategy is a two steps process:~        -  Extensive HIV counselling and testing, and comprehensive prevention programme among a~          target population~        -  Immediate ART initiation after HIV diagnosis, irrespective of CD4 count criteria.~      The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of~     all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the~     population. This is a cluster randomised controlled trial with a total of 22 communities used~     as the units for randomisation. Enrolment of a population of 22 000 individuals among which 4~     400 are expected to be HIV-Infected.~   "
157122|NCT01509495|"~     The purpose of this study is to measure impedance during inpatient treatment.~   "
157123|NCT01509482|"~     Insulin resistance in men can be the underlying major factor in reproductive abnormalities (~     chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic~     ovarian syndrome ( PCOS ) in women.~   "
157124|NCT01509469|"~     The purpose of this study is to determine whether ileal infusion of casein and sucrose can~     activate the ileal brake.~   "
157125|NCT01509456|"~     Mainly due to the absence of gravitational forces in weightlessness, astronauts suffer from~     an increased bone loss- negatively affecting health and vitality during a mission. The~     development of effective countermeasures to this loss includes many different aspects like~     sports but also nutrition.~      Alkaline salts, abundant in fruits and vegetables, have shown to have positive effects on~     markers of bone turnover of postmenopausal women but also men and younger adults. With the~     current study the effects of a potassium bicarbonate supplementation added to a standardised,~     strictly controlled, definite diet of healthy, young men, should be verified within 21 days~     of 6°- HDT- Bedrest- the gold standard of simulating weightlessness within earthbound~     conditions.~   "
157166|NCT01508923|"~     This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC~     90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin~     secretion in subjects with type 2 diabetes.~   "
157167|NCT01508910|"~     The purpose of the study is to assess the safety and efficacy of targeted intramyocardial~     delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal~     symptoms in subjects with refractory angina and chronic myocardial ischemia.~   "
157168|NCT01508897|"~     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two~     formulations of liraglutide.~   "
157126|NCT01509443|"~     Overall goal: To apply the investigators' well defined simple, few-minute breathing/ mild~     physical exercise program and evaluate its efficacy/benefits for the improvement of~     clinico-immunological outcome in obese patients with asthma.~      Rationale & Hypothesis: Different breathing exercise regimens currently recommended are not~     well defined and in certain cases may worsen dyspnea or even trigger an asthma attack.~     Therefore, it is important to evaluate the overall usefulness of a breathing exercise as a~     therapeutic intervention of asthma. In this regard, the investigators have designed an easy,~     few-minute breathing exercise program as a treatment modality for asthma and to evaluate its~     efficacy in improving associated clinico-immunological symptoms. The investigators~     hypothesize that the investigators' well-designed breathing/mild physical exercise~     intervention for obese patients will help alleviate the stress and symptoms of asthma by~     reducing the chronic low-grade systemic inflammation and thus potentiate the beneficial~     outcome of medication to render a better control over the disease and to improve the quality~     of life in obese patients.~      Clinical relevance/Significance:~      The investigators expect that their exercise module will help reduce inflammation caused by~     asthma, and thereby relieving symptoms of asthma. If successful, this would allow regular~     individualized exercise module to be recommended as a part of therapy for people with asthma,~     which could possibly reduce the dosage as well as frequency of taking medicine that they~     need.~   "
157127|NCT01509430|"~     Head and neck cancer patients often experience a critical weight loss of around 10% following~     radiation therapy. Of this up to 70% is muscle mass and is an independent predictor of~     mortality, lowers muscle strength and functional performance. The purpose of this study is in~     a randomized controlled trial to investigate the effects of progressive resistance training~     (PRET) on changes in muscle mass, muscle strength and functional performance in head and neck~     cancer survivors. The investigators hypothesize that PRET has a positive effect on all~     primary endpoints and increases muscle mass, muscle strength and functional performance.~   "
157128|NCT01509417|"~     The objective of this study is to scientifically evaluate the ability to discharge patients~     based on feeding schedule comparing ad lib feeds to our current scheduled regimen.~      The hypothesis is that patients may be able to be discharged sooner with ad lib feeds.~   "
157129|NCT01509404|"~     The purpose of the study is to assess the incidence and severity of late Cytomegalovirus~     (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and~     200 days and after 200 days post-transplant in patients treated with valganciclovir per~     package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant~     versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam~     100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.~   "
157130|NCT01509391|"~     In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin~     in patients with chronic hepatitis c infection and liver cirrhosis. The investigators~     hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in~     patients infected with hepatitis c.~   "
157131|NCT01509378|"~     The aim of the study is to characterize and quantify the relative effectiveness and~     contribution of implantable cardioverter defibrillator (ICD) therapy to the clinical outcomes~     under the conditions of daily practice.~      Swiss, multicenter, prospective, observational study.~   "
157132|NCT01509365|"~     The purpose of the study is to determine whether administration of 150 mg clopidogrel is~     effective in reducing the one-year incidence of thromboischemic events in patients with high~     on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population~     overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.~   "
157133|NCT01509352|"~     This is a prospective trial of the utility of esophageal stitches during fundoplication.~      The hypothesis is that recurrence rate may be different with or without the esophageal~     stitches.~   "
157134|NCT01509339|"~     The purpose of this study is to determine the pharmacokinetics and safety of inhaled~     vancomycin in patients with cystic fibrosis.~   "
157135|NCT01509326|"~     This study will investigate the effect of chiropractic treatment with and without the use of~     an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups~     with and without the pillow and will be followed for five weeks. The primary outcome measure~     will be headache frequency. The investigators predict that the group using the pillow on a~     daily basis will demonstrate significantly greater decrease in headache frequency over a~     5-week interval.~   "
157136|NCT01509313|"~     Outpatient polyp treatment can be performed in a few different ways but generally involves~     passing a special type of hysteroscope (3-6 millimetre in diameter) into the womb through~     which specifically designed miniature operating instruments are passed to remove the~     polyp(s). At present the most commonly used instruments use an electrical cutting edge.~     However, a new instrument using a mechanical cutting edge has come to market. In patients~     having a general anaesthesia the mechanical cutting instrument has been shown to be easier to~     learn, more effective at completely removing polyps and quicker. However, the instrument is~     slightly larger, which could potentially cause more discomfort and prolong the procedure in~     the outpatient setting. Therefore, the investigators want to compare the electrical and~     mechanical instruments for speed, completeness of polyp removal and patient acceptability.~   "
157137|NCT01509300|"~     RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide~     and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the~     setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition,~     T-cell depletion may contribute to prevent developing severe acute graft versus host disease~     (GVHD) in haploidentical transplantation.~      PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine,~     cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical~     donors in treating patients with acute leukemia and myelodysplastic syndrome.~   "
157138|NCT01509287|"~     This study focuses on the genetics and metabolism of Donnai-Barrow Syndrome (DBS).~   "
157224|NCT01508143|"~     The aim of this study is to compare two misoprostol regimen in pregnancy termination.~   "
157334|NCT01506700|"~     This is a single-arm, prospective, study of an optical imaging device on approximately twenty~     (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be~     performed on study subjects with results being compared to final pathology.~   "
157139|NCT01509274|"~     The purpose of our study is to determine whether one injection with plasma into the origin of~     the plantar fascia is an effective treatment of plantar fasciitis.~      90 patients will be randomized into three groups. 30 patients will be treated with one plasma~     injection, 30 patients will be treated with one injection with saline and 30 patients will do~     physiotherapy and use heel cups. The two groups who receive injections will do the same~     physiotherapy and use heel cups, as the conservatively treated group.~      Both groups randomized to receive an injection will have a 10 ml blood sample taken from~     their cubital vein. The sample is centrifuged for 5 minutes at 5000 rpm. No additives are~     added. 3 ml of plasma i obtained, and the syringe i blinded. Is the patient randomized to~     receive an injection with saline, a similar syringe is blinded with 3 ml of saline. The~     injection into to the origin of the plantar fascia i done 10 minutes after the sample of~     blood is obtained. The content of the syringe i blinded to both the investigator and the~     patient.~      The injection i performed from the medial aspect of the heel under guidance of ultrasound. No~     local/systemic analgetic is used. The content of the syringe is spread using peppering~     technique into the origin of the plantar fascia.~      Patients will do questionnaires at inclusion and after 1, 2, 3, 6 and 12 months. The~     questionaires will be Foot Function Index and SF-36 as well as questions about their use of~     analgetics, use of heel cups and intensity of their physiotherapy~   "
157140|NCT01509261|"~     This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive~     esophagitis and resolution of heartburn.~   "
157141|NCT01509248|"~     1. Population pharmacokinetics : The purpose of this study is~           - to investigate the population pharmacokinetics of theophylline in premature Korean~          infants and to assess the influence of demographic and clinical covariates.~        2. Metabolomics : The purpose of this study are~             -  to predict serum theophylline levels and to assess CYP1A2 activities in premature~               infants by analyzing urinary metabolites of theophylline~             -  to examine which factors affect clearance of theophylline and CYP1A2 activity in~               premature infants~   "
157142|NCT01509235|"~     In the current study, we designed a cross-over, open label, randomized controlled clinical~     trial that aim to investigate the superiority of physical exercise coupled with self drainage~     to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children~     undergoing physical exercise coupled to self drainage will increase the amount of expectorate~     secretions compared to conventional CP course, while being more satisfied and without~     worsening their pulmonary function status.~   "
157143|NCT01509222|"~     The main objective of this study is to investigate the effect of a personalized nutrition~     intervention on the dietary pattern of apparently healthy adults with one or more children~     aged 4 to 12 years.~   "
157144|NCT01509209|"~     The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the~     treatment of vasomotor rhinitis~   "
157145|NCT01509196|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of HIP0901 capsules and Lipidilsupra tablets.~   "
157146|NCT01509183|"~     Propeller Health is collaborating with Dignity Health (formerly Catholic Healthcare West~     (CHW)) to carry out a focused demonstration project to evaluate the effectiveness and~     potential cost savings of a deployment of the Propeller Health approach to asthma management.~     The Propeller Health goal is to bring together the best technology and asthma insight in~     order to provide Dignity Health with an engaging, data-driven chronic care program to improve~     asthma management and lower healthcare utilization costs, and to respond to~     prevention-focused reforms to health insurance laws.~      This project has been designed to implement and evaluate a data-driven program to improve~     asthma management and control and lower direct costs through reductions in healthcare~     utilization. This program has been developed by Propeller Health and has gone through~     preliminary testing. Each subject participating in the study will receive an Propeller Health~     device, which captures the time and location of use of inhaled short-acting bronchodilators~     over a twelve-month period. This information is processed and delivered at regular intervals~     to the patient and his or her provider to support improved asthma management.~   "
157147|NCT01509170|"~     The aim of this study is to identify factors associated with hyponatremia among patients~     hospitalized in the internal medicine ward. Consequtive patients hospitalized because of~     hyponatremia will be recruited. Follow up will include clinical factors such as background~     diseases, complete drug history, blood tests including Biochemistry tests (Sodium, renal~     function), endocrinological evaluation, thyroid function tests, cortisol,urinary sodium on~     addmition. One month following discharge follow up Sodium level will be taken.~   "
157148|NCT01509157|"~     The investigators have developed a unique Remote & Safety diabetes management system (MDRS)~     that offers real-time remote monitoring and control of glucose levels. The system allows the~     supervising personal to alarm the patient and intervene in cases such as pending~     hypoglycemia, long standing hyperglycemia or technical faults.The aim of this feasibility~     study is to evaluate the efficacy of the MDRS system in preventing nocturnal hypoglycemia in~     children and young adults with type 1 diabetes.~   "
157149|NCT01509144|"~     Objectives:~        -  To assess the safety of three priming immunisations by nasal route followed by two~          booster immunisations by intramuscular route~        -  To assess immunogenicity responses induced by the vaccine.~   "
157150|NCT01509131|"~     It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar~     bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and~     compliance of the two reduced volume PEG-based bowel preparation will be also compared.~   "
157151|NCT01509118|"~     Arterial and venous thromboembolism represents one of the most common preventable health~     problems. Patients undergoing surgery, especially hip fracture surgery are at high risk for~     deep vein thromboembolism (VTE) without thromboprophylaxis. In the absence of prophylaxis,~     the incidence of fatal pulmonary embolism (PE) after Hip Fracture Surgery (HFS) is reportedly~     4%-12%. Provision of thromboprophylaxis to all patients who undergo HFS is recommended.~   "
157152|NCT01509105|"~     It is an observational multi-center study to assess the safety profile of Prevenar13 used~     among Korean children in the routine clinical setting following a licensure and introduction~     of the vaccine. This study is designed to fulfill regulatory requirement for any new drug~     authorized by KFDA.~   "
157155|NCT01509066|"~     This study will be a 6-month intervention that is examining how different dietary approached~     may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy,~     particularly by measuring changes in weight. Participants will be randomly assigned to~     following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight~     loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat,~     low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products~     (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits,~     vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic~     index, which means you will be asked to favor foods that don't cause a quick rise in blood~     sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will~     receive counseling and supporting materials on the dietary approach you are assigned to~     follow. Both diets are safe and have shown to be effective ways to assist with achieving a~     healthy weight. The investigators hypothesize that both groups will see improvements in~     weight and fertility with possible greater improvements seen among participants in the vegan~     group.~   "
157156|NCT01509053|"~     The purpose of this study is to compare retrospective hospitalization rates of schizophrenic~     patients treated with oral antipsychotics to prospective hospitalization rates of these~     patients treated with IM depot aripiprazole.~   "
157157|NCT01509040|"~     ﻿The purpose of this study is to assess the feasibility of hemofiltration in patients~     resuscitated from cardiac arrest. Cardiac arrest is the loss of mechanical activity of the~     heart including the loss of detectable pulse, or spontaneous breathing. When heart function~     is restored, the cells of the body release molecules into the blood that cause inflammation,~     unstable blood pressure, organ dysfunction and death. Hemofiltration is a technique of~     washing the blood to remove fluid and molecules from it. Hemofiltration is a proven therapy~     for renal failure, but is considered investigational for treatment after resuscitation from~     cardiac arrest. Some experts believe that hemofiltration after heart function is restored can~     remove inflammation from the blood, maintain blood pressure and organ function. Others~     believe that intravenous fluid and medications are sufficient to maintain blood pressure and~     organ function. Since the inflammation that occurs after restoration of heart function lasts,~     the investigators continue hemofiltration for up to 48 hours. Whether hemofiltration or~     intravenous fluids and medications is better is not known. The investigators are checking if~     they can wash the blood of patients resuscitated from cardiac arrest before the investigators~     can begin a large randomized trial to test whether hemofiltration improves their outcome.~      The investigators are testing this by randomly allocating patients resuscitated from cardiac~     arrest to receive low volume hemofiltration, high volume hemofiltration, or intravenous~     fluids and medications alone. The null hypotheses are that less than 80% of eligible patients~     will be enrolled, and that less than 80% of enrolled patients will undergo low-volume or~     high-volume hemofiltration (HF) for at least 80% of 48 hours.~   "
157158|NCT01509027|"~     Hyperphosphatemia is a common and severe complication in chronic kidney disease patients~     treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the~     cornerstones in the prevention and treatment of this complication. However, noncompliance is~     an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial~     proportion of hemodialysis patients. The present study aims at identifying risk factors for~     non compliance and also test the hypothesis that compliance can be improved by education~     patients on the consequences of hyperphosphatemia and the importance of diet and phosphate~     binder therapy.~   "
157159|NCT01509014|"~     Despite proven benefits in reducing morbidity and mortality, many patients become nonadherent~     to statin therapy within the first year of starting. Due to their accessibility and frequent~     patient contact, pharmacists are well-positioned to improve medication adherence.~      The purpose of this study is to determine whether a simple intervention by community~     pharmacists can improve statin adherence in new statin users.~   "
157160|NCT01509001|"~     Aim:~      The purpose of this study is to compare the effects of glimepiride(G) and metformin(M) on~     vascular reactivity, haemostatic factors and glucose and lipid profile in patients with type~     2 diabetes.~      Methods:~      A prospective study will be performed in 20 uncontrolled patients previously treated with~     dietary intervention. Participants will randomized into M (750 to 2500 mg/day) or G (1 to 8~     mg/day) therapy. After 4 months, the patients will be crossed-over with no washout period to~     the alternative treatment for an additional 4-month period on similar dosage schedule.~        -  The following variables were assessed before (basal values) and after 4 months of each~          treatment period:~             1. Hormonal and metabolic determinations: fasting plasma glucose, insulin,~               catecholamine, lipid profile and HbA1 levels.~             2. Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity,~               platelet aggregation, fibrinogen and plasminogen levels.~             3. Cardiovascular evaluation: flow indexes of carotid and brachial arteries. Also, at~               the end of each treatment period, a 12-hour metabolic profile including~               measurements of glucose, insulin, glucagon, proinsulin and triglycerides levels at~               fasting and every 2 hours (7:00 am to 7:00 pm)will be done~   "
157161|NCT01508988|"~     The primary objective of this study is to evaluate the safety and tolerability of ascending~     single doses of ONO-9054 administered as a single drop in healthy adult subjects. The~     secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its~     metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.~   "
157162|NCT01508975|"~     The investigators hypothesize that consumption of either white or brown rice will be more~     satiating than glucose control.~   "
157163|NCT01508962|"~     The goal of PRESS-ALS is to study the earliest manifestations of disease in people with early~     ALS in whom some areas of the body are not yet affected.~   "
157164|NCT01508949|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC~     90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated~     with diet and/or sulphonylurea or repaglinide.~   "
157165|NCT01508936|"~     The primary objective of the study is to characterize the efficacy of reslizumab treatment,~     at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in~     improving pulmonary function in relation to baseline blood eosinophil levels in patients with~     moderate to severe asthma, as assessed by the change from baseline to week 16 in forced~     expiratory volume in 1 second (FEV1).~   "
157169|NCT01508884|"~     Despite the WHO International Health Regulations Emergency Committee declared an end to the~     2009 H1N1 pandemic globally, the emergence of the novel 2009 H1N1 virus in March 2009 has~     affected more than 214 countries with at least 18000 deaths [1]. Patients with chronic~     underlying illness and extreme of ages are at risk of developing severe disease and~     complications [2-3]. Resistance to oseltamivir has also been reported [4]. Therefore,~     vaccination with the 2010/2011 trivalent influenza vaccine (TIV) with the 2009 H1N1-like~     virus incorporated will be the best protection against the influenza infection, especially~     among the at risk population. Recent study on dose sparing seasonal influenza vaccine~     delivered via a novel intradermal microneedle has demonstrated good immunogenic responses~     similar to full-dose intramuscular vaccination [6]. Poor immunogenicity of the H1N1 2009~     component of the trivalent influenza has been reported [7].~      Study has also suggested the combined intradermal vaccination with local stimulation of~     dermal antigen presenting cells by applying imiquimod cream (Aldara) to the injection site,~     which activate antigen presenting cells (APC) through the toll-like receptor 7 (TLR7) may~     produce better immunogenicity [8].~      Imiquimod cream is currently registered for the treatment of warts and basal cell carcinoma.~     Scientific evidence has demonstrated that after treatment with imiquimod, the antigen is~     processed and presented to cells of the adaptive immune system leading to clearance of the~     virus and subsequent clearance of the lesions [9]. In addition to functional maturation,~     imiquimod induces migration of dendritic cells from the dermis to draining lymph nodes~     [10,11]. Subcutaneous administration of imiquimod as vaccine adjuvant simultaneously with the~     antigen of interest, has shown to induce enhanced responses towards the administered antigen~     [12].~      We therefore performed a prospective, double blind, randomized controlled study to compare~     the safety and immunogenicity between intradermal 2011/2012 TIV immunization with~     pretreatment of imiquimod cream and conventional full dose intramuscular 2011/2012 TIV~     immunization with pretreatment of aqueous cream as control.~   "
157170|NCT01508871|"~     This study will evaluate the relationship of markers of cardiac activation and their~     determinants. The hypothesis is that these markers will be interrelated.~   "
157171|NCT01508858|"~     This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide~     changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a~     combination contraceptive drug (Neovletta®).~   "
157172|NCT01508845|"~     This study will examine whether the amount and type of fat, mono-unsaturated fat (MUFA) vs.~     poly-unsaturated fat (PUFA), in a meal affects the absorption of vitamin D, which is taken~     after that meal. The study hypothesis is that vitamin D3 absorption will be greater when fat~     is present vs. absent in the meal. A secondary hypothesis is that vitamin D3 absorption will~     be greater in the presence of a meal with a high MUFA/PUFA compared with a low MUFA/PUFA~     ratio.~   "
157173|NCT01508832|"~     The duration of the autonomic (sympathetic) block will last longer than the sensory block.~     The duration of the increased perfusion index will last longer than either the sympathetic or~     sensory block.~   "
157174|NCT01508819|"~     Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most~     difficult clinical challenges in medicine. There are few data to help guide clinicians in~     this area: estimates of the benefits of ICU admission, especially in the very elderly, are~     sparse. Rates of ICU admission of very elderly thus vary widely by hospitals.~      The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of~     patients over 80 arriving in Emergency Departments (ED) with conditions that potentially~     warrant ICU admission and their outcome six months after ED visit. Overall rate of patients~     deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged~     from 5% to 38% across the participating centers. This variability persisted after adjustment~     for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The~     analysis also revealed that high functional status prior to ICU visit, good nutritional~     status as assessed by an emergency physician and the absence of cancer were of good prognosis~     for outcome six months after ED visit. Only 23% of patients visiting the ED with a~     life-threatening condition and all positive prognostic factors mentioned above were admitted~     to an ICU in the ICE-CUB1 study.~      Hypothesis Elderly patients visiting the ED with a life-threatening condition, high~     functional status prior to ICU visit, good nutritional status as assessed by an emergency~     physician and no cancer will potentially benefit from ICU care and should thus be admitted.~      Main objective Determine whether a strategy consisting of recommendations of ICU admission of~     all patients over 75 visiting the ED with a life threatening condition, no cancer, good~     functional and nutritional status prior to ED visit decreases the mortality of these patients~     six months after ED visit.~      Secondary objective : Assess the impact of the strategy on:~        -  In-hospital mortality~        -  Rate of ICU admission~        -  Place of living and quality of life six months after ED visit~      Primary outcome :Mortality six months after ED visit Secondary outcomes~        -  In-hospital mortality~        -  ICU admission~        -  Change in functional status six months after ED visit~        -  institutionalization~        -  Quality of life six months after ED visit~   "
157175|NCT01508806|"~     This trial is conducted in Oceania. The aim of this trial is to assess whether dose~     adjustment is required for patients with renal impairment by investigating the~     pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.~   "
157176|NCT01508793|"~     The proposed study aims to determine whether an intervention to increase sleep in school-age~     children is associated with positive changes in eating, activity behaviors and zBMI. One~     hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly~     assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce~     a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in~     sleep). Families of children in the optimize sleep group will be taught effective behavioral~     strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month~     follow-up, the following will be gathered: sleep duration (measured by actigraphy), food~     intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry),~     the relative reinforcing value (RRV) of food (measured using a validated experimental~     paradigm), and measured child height and weight.~   "
157177|NCT01508780|"~     It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular~     remodeling. The investigators believe that this study will help document the nature of~     beneficial changes that occur in patients with Pulmonary Arterial Hypertension (PAH) in~     response to bosentan therapy. In turn, demonstrating that changes in pulmonary vascular~     structure and function accompany clinical improvement.~   "
157178|NCT01508767|"~     Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone~     tube) placed in the bladder at the time of operating to monitor kidney function during~     surgery and in the post-surgery period. Such patients will also have an infusion into the~     spine, known as an epidural, after surgery to provide them with continuous pain relief.~     Urinary catheters should be removed as early as possible once they are no longer required to~     facilitate patients becoming mobile after surgery and to reduce the risk of patients~     developing a urinary tract infection.~      Traditionally these catheters are not removed until the patients epidural infusion is~     withdrawn, as in theory to do so would predispose the patient to developing acute retention~     of urine due to lack of sensation when the bladder is full. The investigators hypothesis is~     that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal~     surgery in patients receiving epidural pain relief without a significant increase in rates of~     urinary retention.~   "
157179|NCT01508754|"~     The aim is to evaluate the effect of treatment with Continuous Positive Airway Pressure~     (CPAP) device on clinic and ambulatory blood pressures (BP) of 200 resistant hypertensive~     patients with moderate-severe obstructive sleep apnea syndrome (OSAS).~   "
157251|NCT01507792|"~     Chronic cough is more frequent and severe in women than in men. Women often have decreased~     iron stores, due to menses and pregnancies. Aim of the study: to investigate if iron~     deficiency has a role in chronic cough by favouring airway hypersensitivity to inhaled~     irritants.~   "
157180|NCT01508741|"~     PURPOSE: The purpose of this investigation is to determine if a relationship exists between~     the administration of a dietary supplement containing 5-ALA and sleep and mood.~      HYPOTHESIS: There are several possible mechanisms for improvement in sleep and mood. In one~     study involving test mice, researchers found that the regular administration of 5-ALA~     appeared to raise serotonin levels in the brain. One hypothesis is by increasing serotonin~     levels, 5-ALA may contribute to improvements with sleep, along with additional improvements~     in mood, calmness, irritability and coping abilities. 5-ALA may also support hormonal~     regulation, including melatonin, in the pineal gland and corticosteroid regulation in the~     adrenal glands.~      Another hypothesis is that 5-ALA may have an impact on increasing the energy and metabolism~     of cells, such that its own circadian rhythms are better defined. 5-ALA may support neuronal~     function and assistance with mental energy needed to deal with stress in daily life,~     producing better feelings of coping, less irritability and lowering an individual's~     feelings of fatigue, all of which may contribute to a reduction of pessimism regarding~     the ability to deal with daily tasks.~      DESIGN: This will be a double-blinded, randomized parallel-group comparison study.~      SAMPLE: 40 participants will be randomized to the following 2 study groups for each outcome~     variable (Sleep and Mood): Control Group - 20 participants and Intervention Group - 20~     participants. A table of random numbers will be used to assign the participants.~   "
157181|NCT01508728|"~     Ortheses are commonly used for the repair of damage to the musculoskeletal system. However,~     immobility, by itself, causes serious side effects that require long and costly~     rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the~     proprioceptive and tactile flow in order to maintain the activity of their host brain areas~     and thus reduce significantly the usual therapy duration. The clinical study Orthosens will~     evaluate the efficacy and safety of the Sensory Feedback Ortheses.~   "
157182|NCT01508715|"~     The purpose of this study is to compare two different physical therapy exercise programs in~     persons who have shoulder pain in order to determine if they have a different affect on pain~     level and ability to use the injured shoulder after treatment. Both exercise groups will~     attend physical therapy for an hour,two to three times a week, for eight weeks. The first two~     weeks of therapy sessions will involve learning the exercises and testing to determine what~     weight to use during exercises. One group will perform a traditional therapy exercise program~     for shoulders using hand weights. The other group will perform a version of the same shoulder~     exercises but with a different exercise technique. Exercises in both programs are part of the~     standard of care for shoulder impingement in physical therapy but one program concentrates on~     the lowering portion of the exercise (eccentrics) while the other emphasizes the lifting~     portion of the exercise (concentrics). Both groups will perform the same warm-up, stretching,~     and cool-down exercises. Participants will also be required to perform a daily home exercise~     program of stretches and range of motion that will take about 20 minutes to complete.~     Exercise testing will determine the hand weight resistance used by each person during their~     therapy sessions and re-testing will occur every two weeks to determine any changes in the~     weight used for the exercises to keep them challenging. Pain level, ability to use the~     injured arm for daily activities, strength, and amount of movement in the shoulder, will be~     measured at the start of physical therapy and after five and eight weeks (end of study) of~     the exercise treatments. A concurrent study investigating the reliability of the shoulder~     motion and strength measurements used in the larger study will also be performed.~      Research hypotheses:~        1. Adults with shoulder pain who complete the eccentric progressive resistive exercise~          intervention will demonstrate significantly greater improvements in the outcome measures~          at three weeks, earlier in the intervention, than the concentric progressive resistive~          exercise intervention group.~        2. Adults with shoulder pain who perform progressive resistive exercise interventions,~          regardless of contraction type, will demonstrate significant improvement in the shoulder~          outcome measures at three and six weeks of intervention.~   "
157183|NCT01508702|"~     This study will assess the serum uric acid lowering effects and safety of lesinurad compared~     to placebo in patients who are intolerant or have a contraindication to allopurinol or~     febuxostat.~   "
157184|NCT01508689|"~     The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars~     will increase calcium intake in healthy adult women.~   "
157185|NCT01508676|"~     The purpose of this study is to see if the drug Pennsaid (Diclofenac) can help reduce pain~     felt by people with chronic nerve pain. The drug will be used 2-4 times each day for 2 weeks.~      The U.S. Food and Drug Administration (FDA) has approved Pennsaid to treat osteoarthritis~     (bone pain), but the FDA has not approved Pennsaid to treat neuropathic (nerve) pain.~      The research study will compare Pennsaid to placebo.~   "
157186|NCT01508663|"~     The primary purpose of this study is to determine whether PCI added to OMT could be superior~     over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in~     elderly patients with coronary artery disease (CAD) during the additional 12 months.~   "
157187|NCT01508650|"~     Rehabilitation and Exercise Training after Hospitalization: Assessing Benefit in Acute Heart~     Failure (REHAB-HF) pilot is a multi-site, randomized clinical pilot study designed to~     establish the feasibility of conducting a larger clinical trial to address the hypothesis~     that, in addition to standard care, a novel, progressive, multi-domain 3-month rehabilitation~     intervention administered to elderly patients with acute decompensated heart failure (ADHF)~     will improve key clinical outcomes, including the rate of rehospitalization and death,~     physical function, and quality of life.~   "
157188|NCT01508637|"~     Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated~     diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system~     a trial of alpha-blocker terazosin is also used. Each participant completes four study~     sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at~     300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure);~     2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter air~     plus placebo. The investigators assess outcomes of blood pressure, forearm brachial artery~     ultrasound, and plasma measures of endothelial activation. The investigators hypothesize that~     DE exposure will be associated with increased blood pressure, decreased brachial artery~     diameter, and increased circulating endothelins, and that these effects will be attenuated by~     terazosin administration.~   "
157189|NCT01508624|"~     This research will evaluate the impact of interventions to improve pain relief and recovery~     following office based surgery.~      There will be three phases to this research. The first phase will focus on predicting~     recovery from office based vein surgery using a multiple regression analysis.~      Phase two will incorporate a randomised controlled trial to compare the effectiveness of a~     range of interventions in anxiety and pain reduction and recovery for office based vein~     surgery patients.~      The final phase of the investigation will utilise qualitative methodology to explore~     patients' experiences of each intervention and their opinions about what was and was not~     effective.~   "
157190|NCT01508611|"~     This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the~     treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent~     molars compared to a control group that performs only the cross-toothbrushing technique and~     evaluate the acceptability and satisfaction of patients and responsible for the application~     of the solution cariostatic.~   "
157191|NCT01508598|"~     Identification and validation of early chronic disease biomarkers in children is of paramount~     importance especially in the burgeoning arena of pediatric obesity research. Despite the~     presence of risk factors, few obese children develop overt cardiovascular disease (CVD) early~     in life. However, because CVD is a cumulative process occurring over time, identifying the~     earliest signs in order to intervene sooner may have a large impact on slowing its~     progression. Endothelial activation is one of the earliest detectable signs of the beginnings~     of CVD. However, accurately quantifying endothelial health in children has proven to be a~     major challenge. Direct measures of endothelial cell biology, such as circulating endothelial~     cells (CEC) and endothelial microparticles (EMP), have been extensively studied in adults and~     are associated with vascular diseases, CVD risk factors, and CVD events. Despite being~     well-validated in adults, CEC and EMP have not been formally evaluated as disease biomarkers~     in children and adolescents. Pediatric obesity is an ideal condition in which to validate CEC~     and EMP as disease biomarkers since adiposity in childhood is associated with CVD, type 2~     diabetes mellitus, and premature death, later in life. The investigators primary focus in~     this study will be the evaluation of CEC and EMP as biomarkers of CVD risk and whether~     substantial changes in weight affect these biomarkers. The investigators propose to evaluate~     the change in levels of CEC and EMP in response to substantial weight loss in 32 adolescents~     with extreme obesity undergoing elective, clinically-indicated bariatric surgery.~   "
157192|NCT01508585|"~     Bariatric surgery is the most effective treatment for patients with extreme obesity.~     Psychological interventions are not routinely offered in Bariatric Surgery Programs.~     Preliminary evidence suggests that Cognitive Behavioral Therapy (CBT) might be effective in~     reducing binge eating and improving surgical outcomes. The current study will examine whether~     the addition of telephone-based CBT (Tele-CBT) to the usual standard of care is more~     effective than the usual standard of care alone, and whether it is more effective when~     delivered prior to or following bariatric surgery.~   "
157193|NCT01508572|"~     The purpose of this study is to determine the uptake, (semi-)quantification and localization~     of the VEGF targeting fluorescent tracer bevacizumab-IDRye800CW in breast cancer tissue,~     surrounding healthy tissue, tumor margins and lymph nodes. This is measured in surgical~     specimens after a single intravenous administration of 4,5 bevacizumab-IDRye800CW, using~     fluorescence microscopy and macroscopy techniques. Also the safety of bevacizumab-IDRye800CW~     is assessed. Another purpose is to assess the abilities of three different fluorescent signal~     detection systems to detect the fluorescent signal pre- and intra-operatively.~   "
157194|NCT01508559|"~     The treatment of HIV and the tests performed for HIV care have changed over the last 20 years~     but improvement of management of HIV-infected subjects is still warranted. The investigators~     would like to collect and analyse clinical information obtained from subjects who are between~     18 and 50 years of age. The investigators will look at routine clinic information such as~     blood pressure, recent blood test results and clinical history. The investigators will then~     assess cognitive (brain) function by talking and/or written tests. These tests will include~     tests for memory, depression and anxiety.~      All of those who are identified as having problems with their brain function in this way will~     be offered onward referral for further assessment as appropriate. Those taking part will be~     offered a follow up visit at 24-48 weeks after the first assessment to see if there are any~     changes. This will allow us to understand how brain problems develop, get worse, or get~     better over time. No genetic research will be done. Depression is a mental health condition~     that can be characterized by negative feelings, a generally low mood, or problems with eating~     and sleeping normally. Anxiety is also a mental health condition where a person can feel~     general anxiousness or fear of specific situations, or, in more serious cases, can have panic~     attacks. Impaired brain function is a condition of the nervous system or brain where the~     brain does not function as well as it normally should, and can include symptoms such as~     forgetfulness, doing everyday tasks more slowly or becoming disorientated to the time of day~     or the place one is in.~      For this study, the investigators will also collect data from medical records, including (and~     if known)social and educational-related data, HIV infection-related data (e.g. date of~     diagnosis, blood test results), relevant medical history (e.g. previous psychiatric~     conditions) and medication used (e.g. date started, the drugs used).~      The information the investigators will get from this study will be used to inform healthcare~     providers (doctor, nurse, health advisor, psychologist) on whether it is necessary to~     routinely assess HIV infected patients for the presence of anxiety/depression and impaired~     brain function. The investigators will also get information on whether the treatments used~     for HIV infection make a difference to how commonly these conditions occur in patients.~   "
157195|NCT01508546|"~     Rationale~      Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant~     treatment planning.~      Purpose~      Randomized phase III trial to compare the effectiveness of surgical therapy with or without~     axillary dissection following conservative treatment in women with stage I breast cancer.~      To determine the possibility to avoid axillary surgery in patients with early breast cancer,~     finding an alternative method to define the need of adjuvant treatment without compromising~     long-term disease control.~   "
157196|NCT01508533|"~     This study was designed to support site preparation and to conduct a disease burden study for~     the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.~   "
157197|NCT01508520|"~     Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and~     microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI~     for differential diagnosis among early gastric cancers (EGC) have not been fully~     established.The study is based on the hypothesis:~        1. ME-NBI is useful in distinguishing EGC from other gastric lesions~        2. ME-NBI is useful in further differential diagnosis among EGCs.~   "
157198|NCT01508507|"~     Various field studies has found that the modified , bivalent, whole cell - based oral cholera~     vaccine (OCV) to be safe, immunogenic and effective with protective efficacy of 67 % in~     earlier clinical trials. However, the effectiveness of the vaccine in real life situation~     using the public health system is unknown. It is critical to follow up in the same~     population, where pilot introduction of OCV was introduced and evaluate vaccine proactive~     effectiveness at individual as well as at population level. The follow - up and determination~     of effectiveness of mass OCV vaccination was requested by State Government.~   "
157209|NCT01508351|"~     Hypotension is a recognized frequent complication of induction of anesthesia. The intent of~     this research is to determine the incidence of hypotension in patients receiving anesthetic~     induction with propofol. This investigation seeks to examine how normal clinical practice or~     a real world understanding of the usual response to propofol affects hemodynamics without~     isolating or standardizing other variables. The current research concerns hypotension in~     normal clinical practice where variability exists. This project aims to gather information~     and data in an attempt to form a foundation upon which each of the other variables affecting~     blood pressure may be subsequently assessed.~   "
157378|NCT01506128|"~     The investigators tried to know whether a virus causing cervical cancer could be detected in~     menstrual blood and to set up a experimental setting to detect the virus.~   "
157199|NCT01508494|"~     The investigators would like to conduct a double blind placebo-controlled prospective study~     to show the impact of a treatment combining a specific cognitive rehabilitation program and~     acetylcholinesterase inhibitors on executive function of young patients 3 months after a~     first symptomatic stroke. The secondary objectives will be to assess cognitive changes~     performance (executive but also non trained functions such as memory) before and after~     treatments and treatment effect on activity of daily living and on quality of life.~      The main objective of this study is to show the impact of this combined treatment on brain~     activation maps in VCI-ND patients in the post-acute phase (3 months) after a stroke.~     Treatment effect will be assessed by functional MRI (fMRI) while patients will be performing~     a specific executive task.~      The investigators hypothesize that the specific rehabilitation associated with~     acetylcholinestrase inhibitors treatment will focalize cerebral activation observed in fMRI,~     improve executive functions specifically, improve non trained cognitive functions~     (generalization effect).~   "
157200|NCT01508481|"~     Emerging evidence suggests that vitamin D [25-hydroxyvitamin D; 25(OH)D] may play a role in~     the etiology of type 2 diabetes. Vitamin D levels are lower in those with type 2 diabetes and~     impaired glucose tolerance (IGT) compared with those with normal glucose tolerance (NGT). In~     addition, a few prospective studies have shown a significant inverse association of baseline~     serum 25(OH)D with incident diabetes. To date, however, the exact mechanisms through which~     vitamin D affects diabetes risk are not yet fully known, particularly whether vitamin D plays~     a role in insulin resistance (IR) and/or b-cell dysfunction, the main pathophysiological~     disorders underlying type 2 diabetes. So, the investigators plan to examine the prospective~     associations of baseline vitamin D [25-hydroxyvitamin D; 25(OH)D] with insulin resistance~     (IR), b-cell function, and glucose homeostasis in subjects at risk for type 2 diabetes.~   "
157201|NCT01508468|"~     The Membranous Nephropathy is one of the most common cause of Nephrotic Syndrome of adults.~     In 2/3 of patients the cause of the disease is idiopathic. This can also be referred to as~     idiopathic membranous nephropathy (IMN).The most of these patients are treated by non~     immunosuppressive symptomatic treatment (NIST): antiproteinuric and antihypertensive blocking~     the rennin-angiotensine system. However, the patients resistant to antiproteinuric treatment~     risk to develop an end stage renal disease (ESRD).~      Rituximab has been recently used in patients suffering of nephrotic syndrome related to IMN~     in four international studies. Rituximab appears effective and safe in reducing proteinuria~     in nearly 60% of patients.~      The primary outcome of the investigators prospective randomized study is to determine whether~     or not the Rituximab associated with NIST is more effective than non immunologic symptomatic~     treatment alone in inducing long term remission of proteinuria.~   "
157202|NCT01508455|"~     The primary objective of this study is to characterize the safety, and efficacy of~     Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a~     continuous IV infusion in preterm subjects, ages ≥ 28 weeks through < 36 weeks gestational~     age.~   "
157203|NCT01508429|"~     Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low~     cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH),~     especially in settings where injectable uterotonics are not yet available or feasible to use.~      A double-blinded individual randomized controlled study of misoprostol versus placebo in home~     deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit~     pregnant women who are likely to deliver at home. All women enrolled in the study will~     receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of~     their baby (ies) and before delivery of the placenta.~      Women who experience a PPH will be randomized to receive either: a) standard of care + 800~     mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets~     resembling misoprostol. In this setting, standard of care is referral.~   "
157204|NCT01508416|"~     Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event,~     especially in newly diagnosed patients and during induction treatment with thalidomide in~     combination with dexamethasone. This association was mainly heightened during the 3 first~     months of chemotherapy.~      Several coagulation abnormalities have been described. Laboratory tests measuring the overall~     thrombophilic tendency might be useful to assess thrombosis risk.~      The aim of this study is to compare thrombin generation by calibrated automated thrombogram~     during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.~   "
157205|NCT01508403|"~     The purpose of this study is to make a cohort event monitoring to see whether and how~     Shuxuetong injection in hospital results in adverse events or adverse drug reactions.~   "
157206|NCT01508390|"~     In this study, participants will have standard Androgen Deprivation Therapy and undergo~     standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity~     Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone~     will be given using the CyberKnife, rather than using the standard Intensity Modulated~     Radiation Therapy. This study will also see how CyberKnife affects the quality of the~     participant's life.~   "
157207|NCT01508377|"~     For several years now, a very successful treatment of posttraumatic stress disorders has been~     offered in the Netherlands and in Germany. The contact between clients and therapists takes~     place exclusively via Internet. The therapists follow a scientifically tested treatment~     protocol, that defines fixed treatment elements that are adapted to the specific situation of~     the client. The participants can write at home, in their familiar environment which makes it~     easier to work on trauma related issues with their therapist. In the last years the treatment~     was offered in Arabic as well indicating to be an effective treatment for Posttraumatic~     Stress Disorder (PTSD) in Arabic-speaking countries.~      The treatment lasts five weeks. During that time-frame, participants write several texts. The~     participants decide when they want to write. Each time after having received two texts, the~     therapists provide feedback and further instructions. The therapists are all trained~     psychologists, who have received additional training in the interpretation of texts and for~     the application of the treatment protocol.~      The investigators hypothesize that both interventions will significantly improve clinical~     symptoms of PTSD. Furthermore, the investigators expect improvements in secondary outcomes~     such as anxiety, depression and quality of life.~   "
157208|NCT01508364|"~     This is an observational study which will investigate the use of Nexavar as first targeted~     therapy in patients with advanced renal cell carcinoma.~   "
157210|NCT01508338|"~     The purpose of this study is to~        -  determine the effects of 12 weeks of HMB free acid gel, ATP, and HMB free acid gel plus~          ATP supplementation in trained individuals during a periodized training program on~          skeletal muscle hypertrophy, body composition, strength, force, velocity, and peak power~          during loaded and unloaded vertical jumps.~      Additionally, the study will determine if either supplementation protocol prevents the~     typical decay seen in performance following an overreaching cycle performed in the 9th and~     10th weeks of the study.~      Finally, the study will elucidate the mechanisms of action of supplementation on protein~     breakdown by analyzing serum indices of muscle damage (CK, LDH) and anabolic status~     (Testosterone:Cortisol ratio) as well as a urinary indicator of protein breakdown~     (3-methylhistidine).~      We hypothesize that under these conditions that the supplementation protocols will augment~     skeletal muscle hypertrophy, strength, and power and that HMB will blunt increases in serum~     indices of muscle damage, and urinary indices of protein breakdown.~   "
157211|NCT01508325|"~     This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority~     and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet in~     subjects with mild to moderate primary hypertension.~   "
157212|NCT01508312|"~     The purpose of this study is determine if 2 cycles of SGN-35 can be used instead of ICE prior~     to autologous stem cell transplant (ASCT) for relapsed and refractory HL. There are 2 steps~     to treating patients with relapsed or refractory HL. The first step is to shrink the lymphoma~     with chemotherapy. The chemotherapy regimen commonly used is called ICE. ICE is a combination~     of chemotherapy drugs: ifosfamide, carboplatin, and etoposide. The second step of treatment~     is to give high doses of chemotherapy and radiation therapy followed by infusion of stem~     cells. This is called an ASCT. This study will focus on the first step of treatment for~     relapsed and refractory HL.~      ICE chemotherapy can cause many side effects. We believe that there are patients who can~     receive less toxic treatments and still do well. We have learned from past studies that~     [18F]FDG-PET scans (which we will call PET scans) can be used to predict who will do well~     after ASCT. PET scans are tests used to measure the metabolic activity of the disease.~     Patients without abnormal activity on their PET scan (negative PET scan) before ASCT are much~     more likely to be cured than those with activity on their PET scan (positive PET scan).~      In this study, instead of beginning with ICE chemotherapy, the patient will receive a new~     drug called Brentuximab vedotin (SGN-35). SGN-35 is a type of drug called an antibody drug~     conjugate. SGN-35 has 2 parts; a part that targets cancer cells (the antibody) and a cell~     killing part (the chemotherapy). The antibody part of SGN-35 sticks to a target called CD30.~     CD30 is an important molecule on some cancer cells (including Hodgkin lymphoma) and some~     normal cells of the immune system. The cell killing part of SGN-35 is a chemotherapy called~     monomethyl auristatin E (MMAE).~      It can kill cells that the antibody part of SGN-35 sticks to.~      Compared to ICE chemotherapy, SGN-has fewer side effects and does not require inpatient~     admission for treatment. We aim to determine whether patients can avoid treatment with ICE~     prior to ASCT. We will use the results of the PET scan to determine whether the patient needs~     additional chemotherapy before ASCT. If the PET scan is negative, the patient will be~     referred to ASCT and not receive ICE chemotherapy. If the PET scan is positive, the physician~     will discuss further treatment options with the patient.~   "
157213|NCT01508299|"~     Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by~     skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal~     and reproduce false negative results (no allergy) in patients with history highly suggestive~     of allergic reaction. The aim of this study is to compare the reproducibility of different~     commercial extracts and raw food in patients with convincing history of acute allergic~     symptoms related to food .~   "
157214|NCT01508286|"~     The purpose of this early access program is to provide telaprevir to patients with a specific~     type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from~     telaprevir-based therapy but who reside in countries in which telaprevir is not yet~     commercially available and who are not eligible for enrollment into a clinical study of~     telaprevir. The study also aims to collect information on the safety and adverse events with~     telaprevir treatment in combination with peginterferon alfa and ribavirin, which is typically~     used to treat patients with hepatitis C. In addition to hepatitis C viral infection, patients~     in this study will also have a diagnosis of liver fibrosis and compensated liver disease.~   "
157215|NCT01508273|"~     The goal of this behavioral research study is to find out more about the health behaviors of~     cancer survivors. Researchers want to understand the cultural, social, and environmental~     factors related to physical activity and personal diet. Researchers also want to learn if~     cancer survivors who take part in lifestyle interventions have better overall health and~     quality of life than those who do not take part in these interventions.~   "
157216|NCT01508260|"~     The goal of this clinical research study is to learn about the safety and level of~     effectiveness of aquapheresis compared to diuretic drugs. Diuretic drugs are designed to help~     the kidneys to form more urine. They also remove fluids from patients with severe fluid~     overload who have not responded to diuretics.~      Aquapheresis is a procedure that removes excess fluid from the body. Blood containing too~     much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and~     passed through a special filter. The filter separates the excess salt and water from the~     blood. The blood is returned to the patient and the fluid is collected in a bag to be~     disposed. Aquapherisis may benefit patients by removing excess fluid and salt from the body.~   "
157217|NCT01508247|"~     Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of~     epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a~     small proportion of cases. There has been a significant increase in EV71 epidemic activity~     throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have heen~     associated with a severe from of brainstem encephalitis associated with pulmonary oedema and~     high case-fatality rates.~      The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a~     clinically acceptable safety and good immunogenicity for healthy Chinese children and~     infants. According to the immunogenicity and safety results, the 320U with adjuvant with~     immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.~   "
157218|NCT01508221|"~     The purpose of this study is to determine whether the use of Trental and Vitamin E can help~     reduce the incidence of radiation necrosis (a lesion that usually occurs at the original~     tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis~     when it occurs but the hope is that these drugs can be used to prevent radiation necrosis~     from ever occurring.~   "
157219|NCT01508208|"~     The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and~     evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of~     urine for proteinuria is the gold standard for the diagnosis of the condition and allows the~     physician to determine if an hypertensive disorder is related directly or not to the~     gestation.~      The problem is the time it takes and the technical difficulties related to the sample~     collection. An alternative is the quantification of protein and creatinine in a random sample~     of urine. We seek to evaluate if this method is as affective as the gold standard in the~     diagnosis of proteinuria (>300 mg/d).~   "
157225|NCT01508130|"~     This prospective observational study will evaluate the efficacy and safety of two approved~     pegylated interferon-based direct acting antiviral triple therapies in patients with chronic~     hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin~     plus either telaprevir or boceprivir in accordance with local standard of care and US~     labeling will be followed for the duration of their treatment and for up to 24 weeks~     post-treatment.~   "
157226|NCT01508117|"~     The purpose of this study is to determine whether the addition of an investigational~     medication, axitinib, to radiation therapy will improve the outcome of treatment in patients,~     above the age of 70.~   "
157227|NCT01508104|"~     The purpose of this clinical trial is to determine the effects good or bad of combining~     BEZ235 along with Everolimus to determine if it is a safe treatment for patients with~     advanced cancers of different types.~   "
157228|NCT01508091|"~     Calorie restriction is the only experimental manipulation that prolongs longevity in~     experimental animals. The life prolonging effects of calorie restriction are related to a~     lower incidence of tumors and less inflammation, but more importantly, a lower generation of~     reactive oxygen species (ROS). This effect is related to the overexpression of two groups of~     enzymes. One is a group of (NAD+)‐dependent deacetylases called sirtuins whose main actions~     are to increase free fatty acid flow from adipose tissue, improve insulin secretion and~     promote mitochondrial biogenesis in muscle. The other group corresponds to uncoupling~     proteins (UCP), specially UCP 3 that reduces the mitochondrial production of ROS. On the~     other hand, an effect of calorie restriction that is always reported, is a decrease in~     resting energy expenditure. A reduction in the activity of UCP1 in brown adipose tissue could~     be a mechanisms to explain this effect. However sirtuins apparently increase the expression~     of UCP1.Recently PET CT scans have emerged as a non invasive methodology to recognize brown~     adipose tissue activity and indirectly, UCP1 activity. Also measurement of telomere length in~     peripheral blood mononuclear cells has consolidated as a good marker of aging. Two possible~     models of calorie restriction can be studied in humans. One is a retrospective model in which~     adults are separated in those that have maintained a stable weight during adulthood in a~     manner analogous to the weight clamp model of calorie restriction in non human primates. This~     model is only reliable if there are objective records of the weight that the studied subjects~     had 20 or more years ago. In the retrospective part of this project the investigators propose~     to study adults whose weight was recorded previously. The investigators pretend to compare~     telomere length and expression of SIRT1 and 6 in PBMC, plasma 8 isoprostanes and carotid~     intima media thickness between weight maintainers and weight gainers. The investigators~     hypothesis is that weight maintainers will have a better aging profile than weight gainers.~     In the prospective part of the project the investigators will study a human model of calorie~     restriction prescribing a 25% reduction in calorie intake during 3 months and comparing~     groups according to weight loss. At baseline and the end of the study period, UCP3 and SIRT1~     expression in muscle biopsies, SIRT1 and 6 expression in PBMC and brown adipose activity,~     assessed by 18fluorodeoxyglucose uptake using PET/CT will measured. The investigators~     hypothesis is that individuals subjected to calorie restriction will experience an increase~     in the expression of UCP3, SIRT1 and SIRT6 and a reduction in brown adipose tissue activity.~     Simultaneously, these subjects will experience a reduction in oxidative stress markers in~     muscle and plasma.~   "
157229|NCT01508078|"~     This study is designed to characterize subjects in terms of the nature and severity of their~     asthma and in terms of conditions that may alter the clinical expression of asthma. Some~     features will be obtained in all subjects. These include a medical history and baseline lung~     function tests. This characterization forms the basis for our database that facilitates~     research protocols.~   "
157230|NCT01508065|"~     Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic~     goal that is difficult to achieve with current blood glucose monitoring technology. Home~     blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of~     severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy~     to operate glucose monitoring in DM patients for strict glycemic control cannot be~     overemphasized.~      The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an~     acceptable mean relative error when compared to acceptable invasive blood glucose~     measurements.~      The primary objectives of the trial are to determine:~        1. The safety of the Glucometer GM-205 in evaluating blood glucose levels~        2. The accuracy of the Glucometer GM-205 in evaluating blood glucose levels~   "
157231|NCT01508052|"~     We hypothesized that sequential compression device (SCD) compression system might induce more~     decreases on core temperature by increasing lower extremity blood flow. And, this study~     investigated the effects of SCD compression system on body temperature in patients during~     total intravenous anesthesia (TIVA) with propofol and remifentanil.~   "
157232|NCT01508039|"~     The purpose of the study is:~        -  To investigate whether chitin can effect healthy adults, the nasal mucosa in a direction~          that will enhance the immune response to infection~        -  To investigate whether chitin influence of the nasal mucosa is well tolerated, and that~          there is no inflammation, as it seen with exposure to endotoxin.~   "
157233|NCT01508026|"~     To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan~     compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.~   "
157234|NCT01508013|"~     The purpose of this study is to determine whether a skin cancer prevention website is~     effective at reduce female teenagers' desire to use indoor tanning and ultimately their use~     of indoor tanning over an 18 month period.~   "
157235|NCT01508000|"~     Patients presenting with multiple innumerable liver metastases will probably never come to~     resection, however, for all others, including patients with numerous multiple metastases or~     large metastases,resection should be considered after limited chemotherapy.~      There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin.~     FOLFOX was used in the previous EORTC study and is again recommended.~      The addition of targeted agents to standard chemotherapy in the perioperative strategy for~     mCRC might increase the ORR and R0 resectability, without significant increase in toxicity,~     therefore translating to a better outcome.~      It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase~     II study.~      Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery~     Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery~   "
157236|NCT01507987|"~     The objectives of the study are:~        1. To determine the prevalence of externalized conductors at enrollment in Riata®, Riata®~          ST Silicone, QuickSite®/QuickFlex® and Durata® leads~        2. To determine the prevalence of other visual lead anomalies (fracture, subclavian crush,~          kink, broken filars on a shocking coil and other irregularities) by each subcategory at~          enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads~        3. To determine the prevalence of electrical dysfunction at enrollment in Riata®, Riata® ST~          Silicone, QuickSite®/QuickFlex® and Durata® leads~        4. To determine the incidence of externalized conductors after enrollment in Riata®, Riata®~          ST Silicone, QuickSite®/QuickFlex® and Durata® leads~        5. To determine the incidence of other visual lead anomalies by each subcategory after~          enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads~        6. To determine the incidence of electrical dysfunction after enrollment in Riata®, Riata®~          ST Silicone, QuickSite®/QuickFlex® and Durata® leads.~        7. To evaluate the 30-day adverse event rate associated with lead revision procedures~          (include lead extractions or abandonments with or without lead replacement) in Riata®,~          Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads~        8. To determine the prevalence of other insulation anomalies in returned leads for~          Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads. Other~          insulation anomalies include any of the following:~             -  Internal abrasion short under RV shock coil~             -  Internal abrasion short under SVC shock coil~             -  Exposed conductors defined as a breach of the outer insulation~             -  Breach of the internal silicone lumen tubing, but the conductor cable is contained~               within the lead body diameter.~   "
157252|NCT01507779|"~     The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent~     A/H1N1 influenza vaccine (IVACFLU)-—each dose with an HA content of 15 mcg from~     A/California/07/2009 (H1N1)-like virus-—will be safe and immunogenic in healthy adults.~   "
157237|NCT01507974|"~     Urinary tract infection is the most common bacterial infection during pregnancy. Asymptomatic~     bacteriuria is the most common infection, in up to 8% of the population. Symptomatic~     infection may cause cystitis or cause pyelonephritis.~      Among pregnant women with recurrent bacteriuria, preventive antibiotic treatment has been~     found to be efficacious in reducing the bacteriuria rate and the complications.~      the changes of the urinary tract which appear during pregnancy usually resolve up to 3 months~     post-partum.~      The purpose of this study is to examine the efficacy of preventive antibiotic treatment~     during the puerperium.~   "
157238|NCT01507961|"~     Hypothesis: there is a positive correlation between tissue thickness measured from CBCT and~     clinical measurements.~   "
157239|NCT01507948|"~     The investigators are seeking people who have been exposed to a traumatic event in the past~     and have symptoms of posttraumatic stress disorder (PTSD) currently. A person with PTSD may~     feel significant distress when reminded of a traumatic event or feel depressed, anxious or~     jumpy.~      As a part of this study, participants will receive brain MRIs and office assessments before~     and after psychotherapy. The investigators provide the gold-standard psychotherapy for PTSD,~     Prolonged Exposure, free of charge; additionally participants are compensated for their~     time during assessment procedures. This study is exploring the brain circuitry involved in~     improvement in response to psychotherapy.~   "
157240|NCT01507935|"~     This study is initiated to investigate the effect of infant formulas with added specific~     prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.~   "
157241|NCT01507922|"~     It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine~     maleate in the efficacy and safety.~      Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and~     safety.~   "
157242|NCT01507909|"~     Exposure to alcohol related cues, such as the sight of alcoholic drinks, may induce craving~     for alcohol in drinkers. In this study, the effects of exposure to (1) the pictures of~     alcoholic drinks and (2) the imagining of a scene related to drinking on activity in the~     frontal region of the brain in heavy social drinkers will be determined. This study is being~     conducted to develop the methods needed to allow for the detection of cue-induced changes in~     drinkers using the EEG. The objective of this pilot study is to establish procedures for~     detecting alcohol-related cue-elicited changes in EEG activity in heavy drinkers.~   "
157243|NCT01507896|"~     The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in~     subjects with severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B~     undergoing major or minor elective or emergency surgical, dental or other invasive~     procedures.~   "
157244|NCT01507883|"~     Current human IVF technology employs two strategies with respective culture media for embryo~     development; 'let the embryo choose' (utilizes single step media) and 'back-to-nature'~     (utilizes sequential media). To our knowledge, there is not any sibling oocyte study to~     evaluate potential advantages/disadvantages of these strategies on one another.~   "
157245|NCT01507870|"~     Incisional hernia is one ot the most frequently seen long term complications in abdominal~     surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for~     incisional hernia after midline incision remains about 5-20 %. One major risk factor for~     incisional hernia after a median laparotomy is obesity.~      The closure technique of midline incisions has remained unchanged since many decades and~     primarily consists of suturing the linea alba. Interest in prevention of incisional hernias~     with the aid of synthetic mesh is growing and only one large randomized trial is active~     recruiting patients in Germany, Netherlands and Belgium (Prima Trial).~      Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after~     midline incision with an incidence of 22% after 12 months. This high risk group of patients~     may benefit from prevention.~      Some small studies have been performed to evaluate the usefulness and safety of primary~     laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk~     for incisional hernias and a low infection rate, even when used in contaminated wounds such~     as colostomy surgery.~      The goal of this study is to evaluate the effectiveness of incisional hernia prevention after~     elective median laparotomy in patients with a BMI of more than 27. A randomized controlled~     trial will be performed comparing the commonly used technique of running suture to close with~     the aid of a prosthetic onlay mesh. The primary outcome measure will be incisional hernia~     occurrence. Secondary outcome measures will be complications, surgical site infections,~     post-operative pain and quality of life.~   "
157246|NCT01507857|"~     The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71~     Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy~     infants volunteers aged from 6 to 35months old.~   "
157247|NCT01507844|"~     Chronic obstructive pulmonary disease is a disease characterized by small airways~     inflammation and obstruction. The small airways disease produces hyperinflation (air~     trapping), which increases with exercise. Continuous positive airways pressure may reduce~     small airways obstruction and therefore air trapping. Pulmonary function tests including lung~     volumes at rest and and after exercise will be measured. In addition, exercise endurance time~     before treatment and after treatment will be measured.~   "
157248|NCT01507831|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk~     participants with hypercholesterolemia not adequately controlled with their current lipid~     modifying therapy (LMT).~      Secondary Objectives:~        -  To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C)~          levels after 24 weeks of treatment in comparison with placebo.~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time~          points.~        -  To evaluate the effects of alirocumab on other lipid parameters.~   "
157249|NCT01507818|"~     To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on~     narcotic use, pain, and health-related quality of life following shoulder arthroscopic~     rotator cuff surgery comparing: Active treatment versus placebo (Sham).~   "
157250|NCT01507805|"~     The purpose of this study is to observe whether the electroacupuncture (EA) preconditioning~     for five days before operation can improve the outcomes of patients with coronary heart~     disease undergoing geriatric non-cardiac surgery.~   "
157253|NCT01507766|"~     As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN),~     especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and~     stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents~     bacterial and endotoxin translocation and thereby theoretically reduces the incidence of~     infections. Therefore, EEN has the ability to reduce the infectious complications, length of~     hospital stay and mortality of patients with SAP.~      However, the role of EEN is considered to be influenced by intra-abdominal hypertension (IAH)~     in patients with SAP. The previous studies showed that gut was the most sensitive splanchnic~     organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it reduces the~     blood flow of gut, and then results in the development of intestinal ischemia and edema. The~     hypoxia and hypoperfusion of intestine leads to the increase of permeability of the~     intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH could~     result in the gastrointestinal dysfunction. Nevertheless, the different impacts of specific~     IAP values on the tolerance of EEN have not been reported.~      Furthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due~     to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause~     expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up to~     date reporting the association between EEN and IAH in patients with SAP. Therefore, the~     present study aimed to investigate the influence of specific IAP on the tolerance of early~     enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts~     of EEN on the disease severity and clinical outcome of SAP were also researched.~   "
157254|NCT01507753|"~     Childhood bipolar disorder- not otherwise specified (BP-NOS) was originally considered to be~     a milder version of bipolar disorder (BD). Research now indicates that BP-NOS is a highly~     impairing condition. No pharmacologic treatment guidelines exist for BP-NOS. Available~     evidence-based pharmacotherapy guidelines are for BP1; efficacious medications are,~     unfortunately, associated with significant risk for adverse events (Kowatch et al, 2005;~     2009). Previous research on diet and nutrition suggests that omega-3 (Ω3) fatty acids have a~     beneficial effect on mood, which might provide either a primary or adjunctive treatment with~     a more favorable risk:benefit ratio for children suffering from BP-NOS than currently~     available pharmacologic interventions. Psychoeducational psychotherapy (PEP) also has shown~     promise in treating bipolar spectrum disorders in children aged 8-12 (Fristad, 2006; Fristad,~     Verducci, Walters, & Young, 2009); its efficacy in treating BP-NOS specifically has not been~     determined.~      The current study compares Ω3, PEP, and their combination to a placebo supplement and active~     monitoring (AM) in a 12-week trial of 60 children with BP-NOS (15 each with Ω3, Ω3 plus PEP,~     PEP, and placebo, all with active monitoring). Primary goals are to determine: 1) feasibility~     of a) recruiting 60 participants in 2 years; b) participant retention over a 12-week trial;~     and 2) placebo-controlled effect sizes for Ω3, PEP, and combination treatment on manic and~     depressive symptoms. Secondary goals are to explore response curves over time, mediators and~     moderators, treatment response across a broad array of outcome variables, adherence to~     treatment, impact on physiologic parameters often worsened by mood stabilizing medications,~     and experience of side-effects in participants receiving Ω3 and/or PEP. Comparisons of~     results to a parallel study of children with depression with identical design will maximize~     knowledge gained. This pilot study of Ω3, PEP, and combined treatment will provide evidence~     about whether a larger trial is feasible and justified.~   "
157255|NCT01507740|"~     Tumour angiogenesis has been identified to play a critical role in tumour growth and this~     knowledge has led to the identification of new targets for cancer therapy. Multiple~     angiogenic factors are involved in the regulation of angiogenesis, among them VEGF (vascular~     endothelial growth factor) and its receptor are of crucial relevance. The inhibition of VEGF~     signaling by monoclonal antibodies or small molecules (kinase inhibitors) has already been~     successfully established for the treatment of different cancer entities and multiple new~     drugs are being tested in clinical trials. The ever-expanding list of antiangiogenic agents~     being available in the near future will raise the questions when to use which agent and in~     which sequence. As a consequence biomarkers are going to be indispensible tools for choosing~     the most effective drugs and to predict dosing and resistance.~      The present project is based on an academic clinical trial in which patients suffering from~     different cancer types (colorectal cancer, non-small cell lung cancer, renal cell cancer and~     hepatocellular cancer) treated routinely with antiangiogenic agents will be included.~     Consecutive serum and blood probes will be taken and will be examined and correlated with~     functional imaging and the clinical course. The following parameters have been selected:~     soluble markers in the plasma (VEGF, bFGF, ICAM, sVGFR-2 IL-8, SDF1 and Dickkopf 3) and~     cellular parameters like circulating endothelial cells (CEC) and circulating endothelial~     progenitor cells (CEPs).~      In conclusion, the present project is screening for potential biomarkers and biomarker~     combinations relevant for antiangiogenic drugs in different tumour types. The predictive~     value of such profiles should then be evaluated in larger cohorts. In the future such~     profiles could possibly help clinicians to use these agents more effectively and therefore~     also more economically.~   "
157256|NCT01507727|"~     This drug has been developed to treat Hyponatremia. The primary purpose of this study is to~     verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15,~     30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary to~     Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate Antidiuretic~     Hormone (SIADH), despite receiving standard therapy. This study is being conducted in China.~   "
157257|NCT01507714|"~     Urinary stress incontinence is defined as leakage of urine during stress. Urinary stress~     incontinence is a health problem with social, economic and psychological consequences. The~     appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known~     phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which~     has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence~     post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress~     incontinence.~      The aim of this study is to examine the efficacy of transobturator tension free vaginal tape~     (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.~   "
157258|NCT01507701|"~     The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and~     safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the~     investigators wanted to assess appropriate dosage in relation to a) plasma concentration~     levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure~     responses when rising up), and c) reports of possible adverse effects.~      A possible beneficial effect of clonidine in adolescent CFS will be investigated in~     NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.~   "
157265|NCT01507610|"~     The purpose of this study is:~        -  To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg~          OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX®~          (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in~          healthy subjects.~        -  To estimate the relative bioavailability of single-dose intranasal administration of 20~          mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX®~          (sumatriptan) Oral Tablet compared to a single-dose of 6 mg IMITREX® (sumatriptan)~          Subcutaneous Injection, in healthy subjects.~   "
160415|NCT01466361|"~     This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a~     cigarette compared to a matched placebo (a placebo is like sugar pill and contains no~     active).~   "
157259|NCT01507688|"~     The experience of a stroke event may result in a disruption to the survivor's daily life.~     Patients with stroke have reported fears of permanent disability and major concerns over~     their ability to recover and be productive and engaged with family, friends and coworkers. To~     enhance recovery from stroke, the investigators designed a stroke self-management program and~     have pilot tested the program among Veterans recovering from stroke/TIA. The study is a~     three-site, randomized controlled trial designed to test the efficacy of a stroke~     self-management program. The intervention program includes 6 bi-weekly sessions over months~     1-3 followed by monthly telephone calls as the investigators administered in the~     investigators' pilot study during months 4-6 for a total length of program duration of 6~     months. The investigators have added 3 monthly group support sessions during months 4-6 for~     additional peer support. Thus, participants will receive bi-monthly support during months~     4-6. The three intervention sites include the Jesse Brown VAMC in Chicago, the Roudebush VAMC~     in Indianapolis, and the IU Health Methodist Hospital in Indianapolis, Indiana. The three~     hospitals represent facilities with a small, moderate, and large volume of acute stroke care,~     respectively. Additionally, Methodist Hospital includes a greater proportion of women which~     enables us to study the patterns and preferences of women with stroke/TIA and tailor the~     investigators' future programs to prepare for the increasing female Veteran population.~   "
157260|NCT01507675|"~     The primary purpose of the current study is to rigorously test the psychometric properties of~     the INQ-12 and ACSS (Van Orden et al., 2008) in Veterans, something which has not been done~     to date. Factor structure, internal consistency, convergent and discriminant validity will~     all be assessed. Secondary goals are to determine if burdensomeness, failed belongingness,~     and acquired capability are distinct versus overlapping constructs and whether or not values~     mediate the relationship between reasons for living and suicide risk. Lastly, the inclusion~     of the Beck Scale for Suicidal Ideation (BSS) allows us to analyze participants' responses to~     explore whether or not participants can be grouped into those who want to die by suicide~     because they want to escape their problems and those who want to die to influence other~     people.~   "
157261|NCT01507662|"~     There is growing evidence that patients undergoing bone mineral density testing (BMD) often~     do not take important steps to improve their bone health. The investigators will conduct a~     randomized-controlled trial to evaluate the impact of a novel and practical patient~     activation intervention (mailing patients their bone density test results) on the quality of~     bone-related healthcare and the cost-effectiveness of BMD testing. Equally important, the~     investigators intervention could easily be modified to include other patient populations and~     chronic diseases.~   "
157262|NCT01507649|"~     Purpose: To evaluate the effectiveness of a telephone-based intervention using~     cognitive-behavioral approach in preventing postnatal depression and improving quality of~     life in first-time Chinese mothers.~      Hypothesis: Women who receive the telephone-based cognitive-behavioral intervention will have~     a lower level of depressive symptoms (primary outcome) and a higher level of quality of life~     at 6 weeks and 6 months postpartum than those who receive the usual postpartum care.~      Design and subjects: Randomized controlled trial is used. A sample of postpartum women with~     high risk of postnatal depression (EPDS > 9, n = 498) will be randomly assigned to either the~     experimental (n = 249) or the control groups (n = 249). The experimental group receives the~     intervention and the control group receives usual postpartum care.~      Study instruments: EPDS and Medical Outcomes Study Short Form Health Survey (SF-12).~      Interventions: The intervention is based on the cognitive-behavioral approach. It consists of~     five, 30-minutes sessions delivered weekly from postpartum week one to week five via~     telephone.~      Main outcome measures and analysis: Outcomes on postnatal depression and quality of life will~     be measured by EPDS and SF-12, respectively, at 6 weeks and 6 months postpartum. A~     repeated-measures multivariate analysis of variance will be used to compare differences~     between two groups.~   "
157263|NCT01507636|"~     Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb~     movements, which cannot be explained by elementary motor and sensory deficits or cognitive~     problems. Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous~     system and the leading cause of disability in young adults. Apraxia and impaired manual~     dexterity are common problems in patients with MS leading to impaired activities of daily~     living. However, a specific training program to improve apraxia as well as manual dexterity~     in MS is lacking.~      In this study, the investigators want to evaluate the impact of a targeted occupational~     therapy program on apraxia and manual dexterity in patients with MS that have dexterity~     problems.~      Patients routinely seen in the investigators MS consulting hour, fulfilling all inclusion and~     exclusion criteria and willing to participate in the study will be evaluated for Apraxia and~     manual dexterity. In case of Apraxia and/or impaired manual dexterity, patients will be~     randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental~     group) or general physical exercises (control group) for 4 weeks.~      At study entry and study end after 4 weeks, apraxia and manual dexterity will be tested in~     all patients.~   "
157264|NCT01507623|"~     Propofol is widely used by anaesthesiologists for deep sedation and general anaesthesia.~     During recent years nurses trained in the use of low dose Propofol sedation (NAPS) during~     endoscopy have been introduced. The method has been implemented at the endoscopic unit at~     Gentofte hospital since 2008(1). Propofol has a respiratory depressive effect which may~     result in depressed oxygen saturation in the blood (hypoxia). Due to a short acting half life~     this is prevented in the majority of cases. However, in spite of this, hypoxia is experienced~     in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital (unpublished~     data). It is well known that hypoxia constitutes a late expression of reduced oxygen tension~     in peripheral tissues. Whether the addition of capnography to standard monitoring during NAPS~     may be of benefit is widely unknown. The aim of this study is to examine whether the~     additional use of capnography to standard monitoring during endoscopy may improve patient~     safety in patients undergoing low dose Propofol sedation by reducing the number, duration and~     level of hypoxic events. The trial is a randomized clinical prospective case-control study.~   "
157297|NCT01507181|"~     This study will examine the effects of Intravenous (IV) ketamine both in an outpatient~     population and with subjects on the inpatient unit with suicidal ideation (SI).~   "
157425|NCT01505517|"~     The aim of the study is to clarify whether specific loading of the inspiratory muscles~     induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals~     with recurrent low back pain.~   "
157266|NCT01507597|"~     Diabetes(both types) are recognized by high levels of glucagon in the circulation.~      Glucagon is known to increase blood glucose, and might therefore contribute to the respective~     diseases. Under some circumstances the gut hormone GLP-1 inhibits the glucagon secretion.~      The investigators aim to identify the impact of GLP-1 on the glucagon secretion, at~     increasing blood glucose levels in healthy subjects, in patients with type 2 diabetes, and in~     patients with type 1 diabetes.~      The investigators think that the effect of GLP-1 on the glucagon secretion might be dependent~     of blood glucose levels.~   "
157267|NCT01507584|"~     This clinical trial is designed to investigate the efficacy profile of the SENSIMED~     Triggerfish® during 24-hour IOP monitoring in patients with glaucoma or ocular hypertension,~     done three times at monthly intervals under different therapeutic regimen. This trial will~     also evaluate the efficacy of SENSIMED Triggerfish® to detect changes in intraocular pressure~     (IOP) after the water drinking test (WDT) will be investigated.~   "
157268|NCT01507571|"~     The purpose of the study is to investigate whether Danish patients with incurable cancer have~     a need of, interest in and benefit from Dignity Therapy.~   "
157269|NCT01507558|"~     The purpose of this study is to test if dexamethasone, an anti-inflammatory medication~     approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue~     around the blood vessel wall at the time of an angioplasty or atherectomy.~   "
157270|NCT01507545|"~     The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe~     in the treatment of metastatic, colorectal cancer.~   "
157271|NCT01507532|"~     Ceftazidime is a broad spectrum cephalosporin with high activity against a variety of~     Gram-negative pathogens, including Pseudomonas aeruginosa. An open-label study of intravenous~     ceftazidime pharmacokinetics will be performed in patients undergoing intermittent~     hemodialysis at Northwestern Memorial Hospital to determine the clearance of ceftazidime in~     high flux hemodialysis.~   "
157272|NCT01507519|"~     1.) Indigenously developed and designed BioMimeTM is a~        -  predictably safe & efficacious 3rd generation drug eluting stent (DES)~        -  with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low~          strut thickness Co-Cr stent,~        -  highly documented drug Sirolimus &~        -  a biocompatible, biodegradable polymer~   "
157273|NCT01507506|"~     This is a multi-institutional phase III clinical study of interventional type. The trial will~     include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years~     of follow up.~      Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or~     surgical specimen) and who meet all eligibility criteria will be randomized in one~     chemoradiotherapy arm :~        -  Conventional arm: 3-dimensional conformational radiotherapy + Temozolomide~        -  Experimental arm : simultaneous-integrated boost with intensity-modulated radiotherapy~          guided by magnetic resonance spectroscopic imaging + Temozolomide The patient monitoring~          will be regular and standardized. The main objective of this study is to improve overall~          survival of patients treated in experimental group (with simultaneous integrated boost).~   "
157274|NCT01507493|"~     This study was conducted to explore whether the non-synonymous single-nucleotide~     polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative~     pain intensity in the general population undergoing upper abdominal surgery. Methods:~     Patients receiving elective upper abdominal surgery under general anesthesia were recruited~     into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators~     measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO).~     The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled~     analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press~     frequency and drug consumption were recorded.~   "
157275|NCT01507480|"~     Antiangiogenic drugs, such as bevacizumab, are a new treatment strategy in Hereditary~     Hemorrhagic Telangiectasia (HHT). Its systemic administration in patients with HHT improves~     liver damage-related symptoms and epistaxis (cases reported and on-going~     study-ClinicalTrials.gov Identifier #NCT00843440-). To limit the systemic adverse effects of~     bevacizumab and to ease administration, a local administration seems suitable.~      A clinical case recently showed the benefits of bevacizumab nasal spray in these patients.~     Its results were confirmed in a characterization study on bevacizumab transport through~     porcine nasal mucosa (in press).~      It seems necessary to assess the tolerance and efficacy of bevacizumab nasal spray in humans~     for the treatment of epistaxis in HHT with a prospective phase 1 study.~      The primary objective of the study is to evaluate the tolerance of increasing doses of~     bevacizumab administered as a nasal spray in patients with HHT-related epistaxis.~      This phase-1, randomized, double-blind, placebo-controlled, monocentric study is to be~     carried out sequentially (dose escalation) on 5 groups of 8 patients. Each group is made up~     of 6 verum and 2 placebos.~   "
157276|NCT01507467|"~     The purpose of this study is to test the hypothesis that radiotherapy of head and neck~     carcinoma can be improved by hypoxic modification of radiotherapy using nimorazole as a~     hypoxic radiosensitizer in association with accelerated fractionation, in an unselected~     patient population in a global environment.~   "
157277|NCT01507454|"~     This study is conducted in Europe. The aim of this study is to investigate the self-reported~     impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic~     vaginitis due to oestrogen deficiency.~   "
157278|NCT01507441|"~     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in~     the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies DNA samples from patients with Down syndrome and acute~     myeloid leukemia treated on COG-AAML0431 clinical trial.~   "
157279|NCT01507428|"~     This randomized phase II trial studies how well positron emission tomography (PET)/computed~     tomography (CT)-guided radiation therapy works compared to standard radiation therapy in~     treating patients with stage III non-small cell lung cancer. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans,~     to guide the radiation therapy, may help doctors deliver higher doses directly to the tumor~     and cause less damage to healthy tissue.~   "
157330|NCT01506752|"~     The purpose of this study is to investigate the bioequivalence of improved and current orally~     disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each~     of two administration methods (with/without water).~   "
157280|NCT01507415|"~     This study aims to evaluate simple tests of physical function in hospitalised patients with~     chronic obstructive pulmonary disease (COPD) and to assess whether they can predict future~     hospital readmission. The Short Physical Performance Battery (SPPB) is a simple test of~     standing balance, usual walking speed (4-metre gait speed) and ability to stand from a chair,~     which reflects global physical functioning and frailty.~      We hypothesise that the SPPB or 4-metre gait speed can predict future hospital readmissions.~   "
157281|NCT01507402|"~     This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess~     the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in~     healthy volunteers.~   "
157282|NCT01507389|"~     This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in~     subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects~     with normal hepatic function.~   "
157283|NCT01507376|"~     This study is a prospective randomized clinical trial to compare the efficacy of the urinary~     and recombinant hCG on oocyte quality for ovulation induction in women undergoing IVF/ICSI.~   "
157284|NCT01507363|"~     Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The~     investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.~   "
157285|NCT01507350|"~     Increasing risk of impaired renal function as a result of obesity is well known. Early data~     has postulated that weight loss might improve kidney function, but the evidence is rather~     limited due to the difficulties in measuring glomerular filtration rate(GFR) after weight~     loss. Cystatin C, GFR measurement using Cockcroft-Gault (CCG) and Modification of Diet in~     Renal Disease (MDRD) equations, have all yield conflicting results after weight loss surgery.~      The study aim to assess:~        1. use of 51Cr-EDTA Clearance as the methodological gold standard in evaluating changes in~          renal function before and after weight loss surgery.~        2. the reliability of using MDRD, CCG and Cystatin C in measuring GFR after weight loss~          surgery~        3. the differences in alterations in renal function dependent on the surgical procedures(~          gastric bypass, gastric band, sleeve gastrectomy).~        4. the use of urine albumin/creatinine ratio in detecting alterations in microalbuminuria.~   "
157286|NCT01507337|"~     This trial is conducted in Europe. The aim of this trial is to compare the exposure of~     liraglutide in young versus elderly healthy subjects.~   "
157287|NCT01507311|"~     This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC~     90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard~     meal in subjects with type 2 diabetes.~   "
157288|NCT01507298|"~     This is an observational study, which aims to compare the outcomes of ambulatory~     gastrointestinal investigations with physical activity using accelerometry. An ambulatory~     study refers to one in which the patient is monitored freely, often outside of the hospital~     environment. For this the investigators will use a lightweight (7.4g) tri-axial accelerometer~     worn behind the ear.~      For capsule endoscopy, the investigators are interested in how physical activity affects the~     speed of capsule transit through the GI tract. Capsule endoscopy involves a patient~     swallowing a pill which contains a camera, in order to image the parts of the bowel that a~     conventional endoscope cannot reach. A rapid transit may result in insufficient mucosal~     visualisation, which would reduce the sensitivity of the investigation.~      For oesophageal pH monitoring, it is essential that the patient behaves as they would~     normally to produce measurements that represent a standard day. Using accelerometry, the~     investigators can compare the amount, and nature, of physical activity taken throughout the~     investigation to that of the preceding day, or week. In addition, further analysis of motion~     data captured will allow us to correlate specific activities and body orientation with pH~     readings to get a better insight into the pathophysiology of a patient's condition.~      The studies will be conducted over 6-9 months in Imperial College Trust's medical outpatient~     service. All patients undergoing capsule endoscopy or ambulatory oesophageal monitoring will~     be asked to consider participating. Patients will receive the eAR sensor up to 2 days before~     their investigation, and will be asked to wear it until the end of their investigation (not~     whilst sleeping). Capsule endoscopy normally takes less than 12 hours, and pH monitoring~     takes between 24 and 48 hours. Participation makes no difference to the standard or type of~     care that they will receive, the sensor data is additional.~      Hypothesis 1 There is no change in the amount or nature of physical activity taken by~     patients during ambulatory oesophageal pH monitoring or capsule endoscopy.~      Hypothesis 2 There is no correlation between physical activity levels and speed of~     gastrointestinal transit.~   "
157289|NCT01507285|"~     This trial is conducted in Europe. The aim of this trial is to assess the safety and~     tolerability (maximum tolerated dose) after single and multiple doses of NNC 90-1170~     (liraglutide) in healthy volunteers and in subjects with type 2 diabetes.~   "
157290|NCT01507272|"~     This trial is conducted in Europe. The aim of this trial is to assess the safety and~     tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170~     (liraglutide).~   "
157291|NCT01507259|"~     The popularity of chocolate can largely be attributed to its mood elevating properties,~     research shows that it contains antioxidants that also provide physical health benefits. Dark~     chocolate, in particular, contains high levels of an antioxidant called epicatechin, which is~     known to cause changes in blood vessels by relaxing them and increasing blood flow.~      Little is know about the immediate effects of chocolate consumption, or the differences~     between milk and dark chocolate with regards to these effects. The project will investigate~     the effect of a single bar of dark or milk chocolate upon blood flow to the brain, using~     simple ultrasound tests.~   "
157292|NCT01507246|"~     This study is designed to compare the standard of care against EXPAREL(R) to determine if~     total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total~     hospitalization costs.~   "
157293|NCT01507233|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     extended-release injectable suspension) to determine if total opioid consumption is reduced~     when using EXPAREL, therefore possibly reducing total hospitalization costs.~   "
157294|NCT01507220|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     extended-release injectable suspension) to determine if total opioid consumption is reduced~     when using EXPAREL therefore possibly reducing total hospitalization costs.~   "
157295|NCT01507207|"~     Type I laryngeal cleft evaluation and treatment in the pediatric population is an emerging~     science. The largest published series of pediatric patients with type I laryngeal clefts~     shows conflicting evidence in terms of outcomes, resolution of dysphagia and method of~     treatment. A comparison of quality of life outcomes before and after injection laryngoplasty~     has not been carried out. The investigators hypothesize that injection laryngoplasty~     significantly improves symptoms and quality of life related to dysphagia in a pediatric~     population with laryngeal clefts.~   "
157296|NCT01507194|"~     This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV~     ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure~     of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron.~   "
157298|NCT01507168|"~     This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety~     of RO5137382 (GC33) in previously treated patients with unresectable advanced or metastatic~     hepatocellular carcinoma. Patients will be stratified according to the level of GPC-3~     expression in tumors and randomized to receive either RO5137382 (1600 mg intravenously) or~     placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study~     treatment is until disease progression or unacceptable toxicity occurs.~   "
157299|NCT01507155|"~     Genomind has developed and introduced a battery of genetic tests, the Genecept Assay, which~     clinicians can administer to patients using a simple saliva sample technique. The present~     study proposes to enroll 1. Subjects (patients who have consented to using the Genecept~     Assay) and 2. Clinician study participants (clinicians who have ordered the Assay on behalf~     of their patients). This study will involve the collection of responses from both Subjects~     and clinician study participants with the intention of correlating this information to~     Subject genetic data.~   "
157300|NCT01507142|"~     This study has been designed to evaluate a new oral test for therapeutic monitoring of~     HIV/AIDS patients that are receiving the combination Anti-Retroviral Therapy (cART). The test~     will measure saliva-based Stress Response Profiling(SRP) biomarkers using laboratory assays.~     Results of the test will show if HIV/AIDS patients successfully responded to cART.~     Preliminary studies showed that SRP biomarkers were strongly increased in cART-unresponsive~     AIDS patients. However, the diagnostic accuracy of the oral test, patients will be recruited~     to donate saliva: AIDS patients responsive or unresponsive to cART, and controls (acute or~     early HIV patients, and HIV-negative patients with hepatitis).~      The saliva samples will be used to measure SRP biomarker concentrations. Results will show~     whether the biomarker measurements provide accurate and specific diagnostics for ART~     response.~   "
157301|NCT01507129|"~     Low levels of dehydration (the loss of body water corresponding to 2% of the body weight),~     deteriorate physical and cognitive performance and may also be linked to a number of chronic~     diseases. The standard test used for the assessment of hydration status is plasma osmolality.~     This blood test is invasive, requires time and laboratory equipment and is not accurate for~     isotonic dehydration. The goal of this project is to determine whether a new molecular~     technology, saliva-based Stress Response Profiling (SRP) biomarkers, could be used for~     non-invasive diagnostics of dehydration.~   "
157302|NCT01507116|"~     The study is conducted in Africa, Asia, Europe, Japan, North America and South America.~      The multinational surveys will explore the experiences and unmet needs of people with~     diabetes, as well as those of family members of people with diabetes, and of healthcare~     professionals treating people with diabetes.~   "
157303|NCT01507103|"~     The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25)~     administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects~     with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy.~      Tecemotide (L-BLP25) is designed to induce an immune response that may lead to immune~     rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in~     all colorectal cancers and since the adaptive immune system plays a role in the prognosis of~     rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might~     boost the tumor-specific immune response and increase the number of tumor-infiltrating~     lymphocytes (TILs).~   "
157304|NCT01507090|"~     In 'real-world' health care settings there exist a number of circumstances where the weight~     of a child is desirable or even necessary but unavailable. Numerous weight estimation~     strategies have been described but each has limitations. Investigators at Children's Mercy~     Hospitals and Clinics recently developed a weight estimation method and tool that addresses~     the limitations of previously published methods. This study is intended to validate the~     device in a population of children 2 months to 16 years of age.~   "
157305|NCT01507077|"~     The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety,~     and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).~   "
157306|NCT01507064|"~     The purpose of this study is to determine whether neoadiuvant therapy with sorafenib~     increases the efficacy of thermal ablation in inducing the necrosis of hepatocellular~     carcinoma.~   "
157307|NCT01507051|"~     The study objective is to investigate the pharmacodynamics (effects of a drug product) when~     switching the treatment from warfarin to rivaroxaban.~      84 young, healthy subjects will participate; they will be treated following a randomized,~     parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind~     (Treatments A and B) design.~      The first two groups (A, B) will receive warfarin for approximately one week to adjust their~     blood coagulation values to a specific level, i.e. to maintain an INR (international~     normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant~     treatment.~      The first group (A) will receive rivaroxaban for four days, the second group (B) will take~     placebo. On the last day, all subjects in groups A and B will receive vitamin K to neutralize~     the effects of warfarin. The third group (C) will not undergo prior treatment with warfarin~     but will receive rivaroxaban for four days.~   "
157308|NCT01507038|"~     The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617~     after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to~     investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of~     treatment period and 8weeks of follow-up period without treatment.~   "
157309|NCT01507025|"~     The purpose of this study is to investigate the possible effect of hinge location on corneal~     sensation and dry eye syndrome after laser in situ keratomileusis (LASIK).~   "
157331|NCT01506739|"~     The purpose of this study is to confirm bioequivalence between E2020 dry syrup 1% form (0.5~     g), given either with 200 mL of water or suspended in 20 mL of water, and E2020 film-coated~     tablet (5 mg) in Japanese healthy adult males.~   "
157332|NCT01506726|"~     The purpose of this study is to determine whether treatment of unexplained anemia in older~     adults and elevated inflammatory markers with oral salsalate can improve hemoglobin levels~     and improve physical activity and quality of life.~   "
157333|NCT01506713|"~     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's~     Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75~     mg tablet under fasting condition.~   "
157310|NCT01507012|"~     Polyphenols, compounds found at high levels in berry fruit, have been shown to have health~     promoting benefits through various mechanisms both in vivo and in vitro. These benefits~     include antioxidant activity, anti-inflammatory properties, and monoamine oxidase (MAO)~     inhibition. This study aims to expand on the extremely promising animal data in the~     literature, and our own pilot study results, to investigate whether drinks containing berry~     fruit can improve cognitive performance and mood in healthy human participants.~      Our central hypothesis is that fruit extracts can reduce the breakdown of neurotransmitters~     such as dopamine and serotonin. This reduction in breakdown could therefore increase the~     levels of these neurotransmitters and convey some benefits in regards to mood and cognitive~     function. The investigators will assess the pharmacokinetic activity of berry fruit extracts~     on MAO activity to test this hypothesis.~      A second hypothesis is that berryfruit polyphenols may alter circulating levels of glucose~     that may in turn affect cognitive performance and mood.~      A prior study carried out by Plant & Food Research through collaboration with the University~     of Northumbria, UK, found promising results after acutely supplementing participants with a~     berry fruit based drink. This study aims to use the results from the previous study to assess~     in depth the effect of berry fruit drinks on human behaviour.~   "
157311|NCT01506999|"~     The main objective of the GENOCOR project (Genetic mapping for cardiac risk assessment) is~     the setting up of a joint public/private laboratory (GENOCOR-LAB) dedicated to the~     development and testing of new cost-effective technologies exploiting the growing knowledge~     in the genomic correlates of cardiovascular diseases (CVD) and of their evolution; the data~     obtained by the GENOCOR-Lab should especially orient secondary prevention and specific~     treatment of ischemic heart diseases (IHD).~   "
157312|NCT01506986|"~     HEAT (Helicobacter Eradication Aspirin Trial) is a large simple double-blind placebo~     controlled outcomes study of Helicobacter pylori (H. pylori) eradication to prevent ulcer~     bleeding in aspirin users. It will be run by the University of Nottingham, with recruiting~     centres across the UK. This trial is funded by the National Institute of Health Research~     Health Technology Assessment (NIHR HTA) Programme.~      Aspirin use is widespread and increasing in elderly patients. The main hazard is~     gastrointestinal bleeding, which may be increasing because of increasing aspirin use. This~     trial is based on evidence that peptic ulcer bleeding in aspirin users occurs predominantly~     in H. pylori positive people.~      Patients will be identified by their GPs, then asked to attend an appointment with a Research~     Nurse to consent to the trial and take a H. pylori breath test. Those with a positive result~     will be randomised to receive a one week course of either eradication treatment or placebo.~     No follow-up visits are required, but instead information will be extracted from the~     patients' electronic medical record using the MiQuest search tool.~      The trial will continue until 87 adjudicated events (hospitalisation because of definite or~     probable peptic ulcer bleeding) have occurred, which would occur after a mean 2.5 patient~     years of follow-up, if trial assumptions are correct.~   "
157313|NCT01506973|"~     In this Phase I/II clinical trial, the investigators seek to pilot the addition of~     Hydroxychloroquine (HCQ) to a commonly-used front-line therapy of pancreatic cancer,~     gemcitabine/nab-paclitaxel. The investigators plan a run-in to define tolerable doses, and~     will explore doses of 800 and 1200 mg/day in successive cohorts of 6 patients. The~     investigators will assess toxicity continuously, and determine the dose for the Phase II~     trial based on standard toxicity criteria.~      The correlative endpoints of this trial are directed to the pharmacokinetics of HCQ, and~     pharmacokinetic model of HCQ based on data from several ongoing trials, and the data from~     these patients will contribute to refining the model. The investigators will analyze both~     measured and model-predicted indices for their relationship to autophagy induction. Autophagy~     will be assessed as the accumulation of autophagocytic vesicles in the PMNs of treated~     patients, together with the induction of the expression of autophagy-related proteins on~     western analysis, quantitated by densitometry. The investigators will document the rates of~     metabolic response as a consequence of treatment, as a therapeutic marker that may be related~     to the degree of autophagy inhibition. Since the investigators have previously demonstrated a~     key role of JNK1 in the induction of autophagy by chemotherapy, the investigators will~     analyze archival tumor materials to determine variability in this marker, as a baseline for~     potential future trials. Finally, this study will incorporate metabolic profiling by mass~     spectrometry, which will be related to mutations (including Kras) in pretreatment tumor~     specimens. Mutational analysis will be accomplished by targeted sequencing or by~     next-generation sequencing, and the need for fresh tissue for all these endpoints will~     require patients to have a biopsy performed before treatment at at 6-8 weeks after beginning~     treatment. In the previous study of the Hh inhibitor GDC-0973 with the same chemotherapy, the~     investigators were able to obtain repeat biopsies successfully on all patients. The~     importance of these biopsies, to move the science forward in an era in which the tools now~     exist to provide meaningful correlative science, cannot be overstated.~   "
157314|NCT01506960|"~     The purpose of this study is to learn more about lipid rich plaque using Near Infrared~     Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary~     artery stenting and Optical coherence tomography (OCT) imaging.~   "
157315|NCT01506947|"~     To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant~     patients with stage 5 chronic kidney disease.~   "
157316|NCT01506934|"~     A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of~     food on the pharmacokinetics of linifanib.~   "
157317|NCT01506921|"~     Racemic ketamine and S-ketamine are used in clinical practice today. Little is known of their~     difference in effect on cerebral blood flow, volume and metabolism. cerebral blood flow (CBF)~     measuring techniques are limited in time so constant measurement to mirror a dynamic process~     is impossible or very difficult. A novel MRI application, arterial spin labeling, offers the~     possibility that without radiation or contrast, to measure semi-continuous CBF with~     measurements every 60-120 seconds. The investigators will give 14 healthy volunteers both~     study drugs in a randomised sequence with one week apart and measure regional CBF during the~     study period of 45 minutes after a sub-anaesthetic bolus dose of 0,6 mg/kg racemic ketamine~     and 0,3 mg/kg S-ketamine The investigators hypothesize that there is no difference between~     racemic ketamine and S(+)-ketamine with regards to Arterial Spin Labeling (ASL) measured~     cerebral blood flow.~   "
157318|NCT01506908|"~     Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a~     cigarette in smokers~   "
157319|NCT01506895|"~     The purpose of this study is to characterize the systemic and ocular safety and tolerability,~     pharmacokinetics, exploratory efficacy and pharmacodynamics of 3 months of repeat~     administration of oral darapladib in diabetic macular edema patients with centre involvement.~   "
157320|NCT01506882|"~     The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as~     monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in~     the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.~   "
157321|NCT01506869|"~     Phase 1: Baseline investigation (nation-wide survey)~      Aims: To investigate whether diabetes and prediabetes is a risk factor for cancers of all~     sites as well as for specific type of cancer, such as breast and colorectal cancer.~      Subjects and Methods: A nation-wide survey will be carried out in 200,000-250,000 individuals~     selected from 20-25 communities stratified according to geographic regions (northeast, north,~     east, south central, northwest, and southwest China), degrees of urbanization (large cities~     [Beijing, Shanghai, and provincial capitals], midsize cities, county seats, and rural~     townships), and economic development status (as assessed on the basis of the gross domestic~     product [GDP] for each province). A comprehensive examination including questionnaire,~     anthropometric measurements, biochemical analysis will be performed in each study~     participant. Diabetes and prediabetes should be diagnosed by OGTT according to the WHO 1999~     criteria, while the diagnosis of cancer is established on the self-report questionnaire and~     cross checking with the tumor registry or a proof of doctor's diagnosis.~      Phase 2: Cohort follow-up~      Aims : To examine factors that modify the risk of cancer in diabetes, prediabetes and normal~     glucose regulation (NGR).~      Subjects and Methods: To recruit and follow all type 2 diabetes, prediabetes, and~     sex,age-matched NGR (1:1) in each community for at least 3 years. For diabetes, treatment~     target is HbA1c ≤ 7.0% with treatment paradigm recommended by local guideline.~   "
157322|NCT01506856|"~     The purpose of this study is:~      Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion~     weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every~     3 weeks (dd-TCip therapy).~      Phase B: To compare the efficacy and safety of the following two treatment regimens as~     first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary~     peritoneal cancer.~   "
157323|NCT01506843|"~     The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody~     response changes after SLIT using house dust mite allergen with or without bacterial extracts~     in mite-allergic children.~   "
157324|NCT01506830|"~     During restorative procedures, different isolation methods of the operative field can be used~     to promote moisture control and retraction of the gingival tissues. The aim of the present~     clinical trial is to evaluate the effects of two isolation techniques on the clinical~     performance of Class V restorations, as well on the periodontal conditions of restored sites.~     Patients presenting at least two noncarious cervical lesions (NCLs) will be enrolled in this~     study. The NCLs will be randomized into the following groups: (1) isolation performed with~     rubber dam and gingival retraction clamp and (2) isolation provided with cotton rolls and~     gingival retraction cord. Both techniques will be used with a saliva suction device. All~     restorative procedures were performed using a self-etching adhesive system and a nanofilled~     composite resin according to the manufacturer's instructions. The clinical performance of~     restorations will be recorded in terms of fracture and retention of restoration, marginal~     adaptation, marginal staining, postoperative hypersensitivity, and preservation of tooth~     vitality at 1 week, 6 months, 12, 24 and 72 months after placement. The periodontal condition~     of restored sites will be evaluated based on the presence of supragingival plaque, gingival~     marginal bleeding, probing depth, and relative gingival recession.~   "
157325|NCT01506817|"~     The primary objective of the current pilot study is to analyze MRI contrast-enhancement~     patterns in the hands of patients with fibromyalgia as compared to the findings in healthy~     controls. Further, to compare enhancement patterns obtained in fibromyalgia patients with~     those described in inflammatory joint disorders, i.e. rheumatoid arthritis and psoriatic~     arthritis.~      Hypothesis:~      Dynamic contrast-enhanced MRI (DCE-MRI) of the hands in patients with fibromyalgia reveals~     pathological imaging patterns indicative of diffuse non-arthrogenic inflammation of e.g.~     superficial soft tissues and /or muscle with patterns distinct from those of inflammatory~     joint disorders e.g. rheumatoid arthritis and psoriatic arthritis.~   "
157326|NCT01506804|"~     Many patients experience an effect of steroid injection, however the effect is often short~     lasting and recurrence of symptoms is common. The short term effect of injection has been~     shown to be much better than exercise therapy; however over time the superior effect of~     injection compared to exercise does not last. Injection in combination with exercise therapy~     might be a more sufficient therapy than injection alone. The aim of this study is to~     investigate a combination of steroid injection and a 10 week exercise program. In addition,~     the study tests the validity of clinical impingement tests using ultrasound verified~     impingement as gold standard.~   "
157327|NCT01506791|"~     This is an open label, randomised, 2-way crossover, comparative bioequivalence study.~   "
157328|NCT01506778|"~     Most of gynecological office procedure such as endometrial sampling procedure,~     hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device,~     difficult intrauterine insemination or embryo transfer procedures often require the~     application of a single tooth tenaculum to the cervix for steady the cervix, straighten the~     cervicouterine angle and provide countertraction. However, grasping the cervix with a~     tenaculum can be a painful experience for the patient.A randomized controlled trial was~     conducted to evaluate using of tenaculum on pain perception of the patients and the procedure~     performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.~   "
157329|NCT01506765|"~     The results of the study schizophrenia, related disorders and glutathione conducted at the~     Laboratory of Psychiatric Neuroscience (LUNEP) DUPA of Lausanne, reinforce the hypothesis~     proposed that a deficit intracerebral glutathione is a vulnerability factor for Schizophrenia~     at least for a subgroup of patients. While pursuing the baseline study, it is appropriate now~     to try to restore a higher level of glutathione in patients to see if this increase is~     accompanied by an improvement in symptoms, particularly negative symptoms and disorders~     cognitive, particularly resistant to current therapy. N-acetyl-cystein (NAC) is a precursor~     of glutathione which is used clinically for various indications, well tolerated even at high~     doses. The investigators propose a double-blind cross-over with the aim to study if the~     N-acetyl-cystein (at a dose of oral 2g/day) leads on the one hand a rising glutathione brain~     (measured in resonance magnetic spectroscopic) and also improved patients' conditions~     (determined by clinical assessments, psychopathological, neuropsychological, biochemical and~     physiological), while recording any side effects. As a first step, this study should include~     at least thirty patients and last for two to three years. It is important to note that this~     is not a study of medication suggested by a pharmaceutical industry, but a medical search.~   "
157335|NCT01506687|"~     Patients who receive tailored navigation (consisting of a letter and patient navigation~     services) and get screened will be significantly greater than the control group who receives~     treatment as usual.~      A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their~     preferred tests, after undergoing the Patient Navigator intervention and that proportion~     will be significantly greater than the group who opt for FOBT in the control group.~   "
157336|NCT01506674|"~     Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be~     checked for possible correlations between metabolomics patterns and patients' outcomes.~   "
157337|NCT01506661|"~     Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV)~     that usually occurs decades following initial exposure. The risk of developing shingles~     increases with age. Shingles presents as a painful, itchy blistering rash that usually~     involves a single portion of the skin and lasts about 7-10 days. The risk of developing~     shingles increases with age in healthy people, and has been shown in some studies to be~     increased in people with rheumatoid arthritis and other autoimmune diseases.~      Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved by~     the FDA for the prevention of Shingles among people 60 years and older, and is now approved~     for use in people aged 50 years and older. Because rheumatoid arthritis and some of the~     medications used to treat rheumatoid arthritis can impair the body's immune system, it is not~     known how much of an immune response can be generated in people with rheumatoid arthritis.~      The goals of this study are to measure the immune response after standard vaccination with~     Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune~     systems. All participants will be 50 years old or older, and subjects with rheumatoid~     arthritis will not be eligible if they are taking certain biologic medications, including TNF~     inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with rheumatoid~     arthritis will all receive a single vaccination with Zostavax, then will be followed for 12~     weeks to assess the immune response and for the development of local rash or other potential~     side effects.~   "
157338|NCT01506648|"~     Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young~     children immediately after the addition of the enzyme phytase. A randomized single blind~     study~   "
157339|NCT01506635|"~     In this randomized controlled clinical trial, we compare the effects of timolol versus~     placebo for treatment of myopic regression after LASIK~   "
157340|NCT01506622|"~     The occurrence of emergence agitation (EA) in pediatric patients who have received~     sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies between~     10% to 80% depending on the scoring system for evaluation and the anesthetic technique used.~      Many authors reported various strategies such as use of sedative premedication, change of~     maintenance technique of anesthesia, or pharmacological agents administered at the end of~     anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from~     sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end~     of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration~     of anesthesia excessively when these agents are administered as subhypnotic or small dose.~     The typical agents that can be administered in this way are propofol and fentanyl.~      Previous studies demonstrated that the use of either propofol or fentanyl at the end of~     anesthesia could reduce the incidence of EA.~      The purpose of this study is to compare the preventive effect on EA and the characteristics~     of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane~     anesthesia.~   "
157341|NCT01506609|"~     The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide~     or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally~     recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast~     cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.~   "
157342|NCT01506596|"~     The purpose of this study is to evaluate the effectiveness and safety of single agent~     pazopanib in subjects with unresectable or metastatic liposarcoma.~   "
157343|NCT01506583|"~     Currently effective antivials for influenza treatment are two influenza viral neuraminidase~     inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is~     reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is~     that the signal ratio of two reagents (with or without a single concentration of the drug)~     correlates the IC50 value, an accurate measurement of drug resistance but impractical for~     clinical use.~   "
157344|NCT01506570|"~     Dengue viruses can cause dengue fever and other serious health conditions, primarily~     affecting people living in tropical regions of the world. This study will evaluate the safety~     and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy~     adults who have previously been infected with a dengue virus or other flavivirus or have~     previously received a flavivirus vaccine.~   "
157345|NCT01506557|"~     The investigators would like to test the hypothesis that maternal vitamin D supplementation~     during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more~     effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal~     vitamin D status and could be beneficial for maternal and infants bone mineralization and~     body composition (proper proportion of muscle and fat tissues in body weight) and is safe for~     both.~      The investigators also want to confirm that vitamin D supplementation of exclusively~     breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status~     independently of mother's vitamin D supplementation up to 1200 ID/d.~      Additionally the investigators hypothesize that because of changes in lifestyle there will be~     no substantial seasonal differences in vitamin D status of pregnant women at the delivery and~     their newborn infants.~   "
157346|NCT01506544|"~     Hydroxyurea (HU) is approved by the United States Food and Drug Administration (FDA) to treat~     adults with sickle cell anemia. Hydroxyurea has also been tested and used with children with~     sickle cell anemia. However, there are not many studies describing the disposition of drug in~     children less than 5 years old. The FDA has requested this study to better understand how~     children ages 2 to 17 years with sickle anemia absorb and eliminate the drug (this is called~     pharmacokinetics). The investigators will measure how much Hydroxyurea (HU) gets into the~     bloodstream at different time points after taking this medication.~   "
157347|NCT01506531|"~     The objective of this study is to scientifically evaluate two different closure strategies~     for gastroschisis to determine if there is a difference in the two approaches.~   "
157348|NCT01506518|"~     This is a pilot clinical trial to assess the ability of a new ultrasound-based imaging~     method, Double-Push Acoustic Radiation Force (DP ARF) ultrasound, to monitor the progression~     of Duchenne muscular dystrophy. The hypothesis being tested is that DP ARF ultrasound~     delineates changes in muscle composition and function in individual dystrophic muscles, from~     early through late stages of disease development, that correlate to time to loss of~     ambulation in patient volunteers.~   "
157349|NCT01506505|"~     Background and rationale:~      In clinical practice, antihypertensives are generally prescribed for use in the morning,~     whereas some statins are recommended for use in the evening. There is evidence that the~     reduction in LDL cholesterol achieved with some statins is superior when taken in the night,~     but it is unclear whether the additional reduction in LDL cholesterol(and the reported~     improvement in BP control when aspirin is taken in the evening) is offset by a reduction in~     adherence when taking medication in the evening. Current product labelling recommends night~     use for simvastatin and does not state a timing preference for aspirin or blood pressure~     lowering medicines. There is therefore uncertainty concerning the best timing of~     administration of the polypill. This uncertainty will be addressed by this trial.~      Trial design:~      Randomised, open label cross over trial (n=75) of the polypill in the morning compared with~     the evening administration compared with individual agent administration (acetylsalicylic~     acid and blood pressure lowering agents in the morning, and statin in the evening) in~     individuals at high risk of cardiovascular disease. Patients will be recruited to the RHP 2c~     (acetylsalicylic acid 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorthiazide 12.5mg),~     and will be randomly allocated to the sequence of time of administration.~   "
157350|NCT01506492|"~     The purpose of this study is to test the effectiveness of a brief manualized individual~     psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress and~     promote psychological well-being in patients with various types of cancer, including~     metastatic disease.~   "
157351|NCT01506479|"~     The purpose of this study is to learn more about the effects of exercise on patients who have~     been recently diagnosed with Parkinson's disease (PD). The investigators are going to test~     two levels of exercise (moderate to vigorous) against no exercise. The investigators think~     that exercise may reduce the symptoms the of PD, and the investigators hope to learn what~     level of exercise will offer the most benefit.~   "
157352|NCT01506466|"~     Weight variation has been reported as a side effect of chemotherapy treatment in early breast~     cancer patients. To date, there is growing evidence for an increased risk of relapse and~     death in these patients who gain or lose weight. However, causes of weight variation during~     chemotherapy and mechanisms involved in the poor prognosis have been little studied.~      Thus, the investigators are conducting a prospective study to characterize weight variation~     in terms of body composition and to identify the mechanisms involved.~   "
157353|NCT01506453|"~     Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of~     vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric patients~     is limited. Gabapentin is frequently used for VCR-related NP/PN, with variable dosing and~     scheduling regimens, and with varying measures of success. The hypothesis of the study is~     that gabapentin will reduce the severity of NP/PN in patients receiving vincristine during~     treatment for ALL on the Total XVI protocol (or for those being treated as per TOTXVI~     protocol), as measured by two outcome measures: the daily dose of morphine used as needed~     for pain in addition to either gabapentin or placebo, as randomized, and the pain scores~     assessed daily.~   "
157354|NCT01506440|"~     This pilot clinical trial studies cognitive assessments in patients with cancer undergoing~     chemotherapy. Questionnaires that measure cognitive changes during chemotherapy may help~     identify the side effects of chemotherapy.~   "
157355|NCT01506427|"~     The purpose of this trial is to determine what will be the optimal imaging protocol for Head~     and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for~     future studies involving [F-18]HX4 in cancer patients.~   "
157356|NCT01506414|"~     The purpose of this study is to determine whether Recombinant Human Thrombopoietin (rh-TPO)~     in combination with Rituximab are effective and safe in the management of~     Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).~   "
157357|NCT01506401|"~     What is the effect of early high frequency oscillation (HFO) versus a lung-protective~     conventional ventilation (CV) strategy (using HFO only as rescue therapy), on all-cause~     hospital mortality among patients with severe early acute respiratory distress syndrome~     (ARDS)?~   "
157358|NCT01506388|"~     The use of foley catheter was tested many times and proved to be effective for induction of~     labour.~   "
157359|NCT01506375|"~     The aim of the study is to compare the safety, clinical tolerability, immunogenicity and~     efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating~     adjuvant, in a short course administration (5 injections over 4 weeks).~   "
157360|NCT01506362|"~     The objective of the proposed study is to determine whether BL-7040 demonstrates clinical~     efficacy in patients with inflammatory bowel disease (IBD).~   "
157361|NCT01506349|"~     Many patients with celiac disease complain of neurocognitive symptoms such as mental~     confusion, grogginess, difficulty with concentration and forgetfulness after exposure to~     gluten. However, there is little data on any possible association between impaired cognitive~     function and gluten intake in celiac disease. The investigators predict that patients with~     celiac disease, when exposed to gluten, will experience neurocognitive symptoms such as~     confusion, forgetfulness and difficulty concentrating.~      The goals of this study are to determine the prevalence of neurocognitive symptoms after~     exposure to gluten in patients with celiac disease and to characterize the nature of these~     symptoms both in terms of their duration and severity.~   "
157362|NCT01506336|"~     The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at~     50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to~     imatinib.~   "
157363|NCT01506323|"~     The aim of this study was to determine the usefulness of a portable, meditation-based~     intervention called the Mantram Repetition Program (MRP) for Veterans with military-related~     posttraumatic stress disorder (PTSD). This study compared the individual delivery of the MRP~     to individual delivery of Present-Centered Therapy (PCT) at two sites in San Diego,~     California, and Bedford, Massachusetts.~   "
157364|NCT01506310|"~     The purpose of the study is to test whether four lifestyle intervention programs (diet alone;~     diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise),~     delivered to women with GDM during 24-26 weeks of gestational age will help women to improve~     their metabolic pattern, and decrease the incidence of adverse maternal and neonatal~     outcomes.~   "
157365|NCT01506297|"~     Subjective measures of satiety are correlated with biologic mechanisms of appetite control.~   "
157366|NCT01506284|"~     The aims of the present study are:~        1. To evaluate the effect of the induction of anaesthesia and paralysis in terms of changes~          in oscillatory mechanics parameters~        2. To evaluate the mechanical properties of the respiratory system in terms of input and~          transfer oscillatory impedance in response to PEEP changes~   "
157367|NCT01506271|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125~     mg or 250 mg doses of MK-7655 to imipenem/cilastatin in adults 18 years or older with~     Complicated Intra-Abdominal Infection (cIAI). The primary hypothesis is that the MK-7655 +~     imipenem/cilastatin treatment regimen is non-inferior to treatment with imipenem/cilastatin~     alone with respect to the proportion of participants with a favorable clinical response at~     completion of intravenous (IV) study therapy.~   "
157368|NCT01506258|"~     The purpose of this study is to determine whether the plasticity of autologous intravenous~     application of cord blood stem cells would improve the clinical course of asphyxiated~     newborns.~   "
157369|NCT01506245|"~     The aim of this study is to compare the effects of exercise training and family-based~     behavioral treatment, either in individual or in group setting, in pre-pubertal children and~     their mother.~   "
157370|NCT01506232|"~     The study aims to evaluate whether or not an EEG (a type of brain scan) is useful in~     diagnosing youth with either ADHD, BPD, ASD. Youth with ADHD, BPD, ASD, and healthy controls~     (without ADHD, BPD, and ASD) will undergo an EEG, and the results will be analyzed using~     brain activity flow pattern analysis (BAFPA). Twenty subjects with each disorder and twenty~     without any of the disorders under study (controls) will be evaluated. All subjects will be~     comprehensively assessed with structured diagnostic interviews and neuropsychological~     testing. All EEG analyses will be conducted under blind conditions. Conditional probability~     and receiver operating characteristic (ROC) analyses will examine the diagnostic utility of~     the EEG scan, using the clinical diagnosis of ASD as the gold standard.~   "
157371|NCT01506219|"~     Introduction:~      Older adults with multiple illnesses represent the fastest growing sector of society and make~     increasing demands on all sectors of the health care system, particularly in outpatient~     community rehabilitation units due to shorter time of stay in acute care units and hospitals.~     The aim of this study is to investigate the effect of geriatrician-performed comprehensive~     geriatric care (CGC) in older people referred to an outpatient community rehabilitation unit.~      Methods:~      The study is a prospective randomized controlled trial. Settings: two community care~     rehabilitation units in Aarhus Municipality, Denmark. Inclusion: persons aged 65 and older~     from home or hospital. Exclusion: persons who received palliative care or had been assessed~     by a geriatrician during the past month. Intervention: medical history, physical examination,~     blood tests, medication adjustment and related treatments performed by a geriatrician.~     Control: usual care in a community rehabilitation unit. Number of hospital admissions and~     emergency department (ED) visits (primary outcome), number of GP contacts, activities of~     daily living, physical and cognitive functioning, quality of life, data on~     institutionalization, medication status, and mortality are assessed at day 30 and 90 after~     arrival at the rehabilitation unit.~      Project status:~      The outpatient CGC model is developed, implemented and compared with usual care in a~     pragmatic RCT.~   "
157372|NCT01506206|"~     The investigators propose a test of causality by examining a cohort of patients undergoing~     deep brain stimulation (DBS) within the ventral striatum. The investigators will examine~     behavior on and off stimulation across a range of tasks that index different forms of~     impulsivity. Patients will be studied in both the ON and OFF state - that is, they will be~     tested during active deep brain stimulation and 30 min to 1 hour after stimulation has been~     stopped (order of state will be counterbalanced across subjects). The investigators specific~     aim is to test the hypothesis that enhancing ventral striatal signaling (i.e. ON-state DBS)~     will cause more impulsive patterns of behavior across several impulsivity tasks. The~     investigators predict that ventral striatal DBS will increase stop-signal reaction time on~     the stop-signal task and commission errors on the Go/NoGo task, and increase delay aversion~     in a delay discounting paradigm.~   "
157373|NCT01506193|"~     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'~     investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136,~     PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine~     (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.~   "
157374|NCT01506180|"~     The purpose of this study is to compare acute ill elderly medical patients in a geriatric~     department with general medical departments, and to examine the effects of comprehensive~     geriatric assessment in the geriatric setting compared with general medical care.~   "
157375|NCT01506167|"~     This prospective, multi-center, observational study will assess the safety and efficacy of~     Avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who~     have received no previous treatment for advanced disease and are receiving Avastin in~     combination with a standard of care first-line chemotherapy regimen. Data will be collected~     for 1.5 years or until death.~   "
157376|NCT01506154|"~     A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the~     Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the~     Treatment of Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis~     and/or Subdeltoid Bursitis of the Shoulder.~   "
157377|NCT01506141|"~     Elaprase, a large molecular protein, is not expected to cross the blood brain barrier when~     administered intravenously. A revised formulation of idursulfase, idursulfase-IT, that~     differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be~     suitable for delivery into the cerebrospinal fluid (CSF) via intrathecal administration.~      This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric~     patients with Hunter syndrome and cognitive impairment who are receiving intrathecal~     idursulfase-IT and intravenous Elaprase enzyme replacement therapy.~   "
157379|NCT01506115|"~     The prognosis of patients with obstructive jaundice caused by hepatocellular carcinoma (HCC)~     is dismal even after biliary drainage; due to malfunction of the biliary drainage tube caused~     by hemobilia and/or tumor emboli. Photodynamic therapy (PDT) in hilar cholangiocarcinoma~     improves biliary drainage and prolongs survival. The aims of this study were to assess the~     safety and efficacy of PDT in unresectable HCC with bile duct invasion.~   "
157380|NCT01506102|"~     The purpose of this study is to establish reference values for thromboelastography (TEM-A) in~     healthy pregnant women during labor and 2 hours and 24 hours after delivery.~   "
157381|NCT01506089|"~     Many human and animal studies over the past 40 years have revealed that ovaries and Fallopian~     tubes have a lower temperature than core body temperature, especially around the time of~     ovulation and early embryo development. Whether average core body temperature, 37 degrees~     Celsius, is ideal temperature for culture has not been prospectively evaluated. The purpose~     of this study is to determine whether lowering the incubator temperature by 1 degree Celsius~     will result in meaningful improvements in embryo development and pregnancy rates.~      Patients participating in this study will undergo routine in vitro fertilization (IVF)~     stimulation. Following egg retrieval, patients with at least 8 mature eggs will have those~     eggs divided randomly into two groups. Both groups will then under ICSI (intra-cytoplasmic~     sperm injection) to fertilize the eggs. The groups will randomly be assigned to control or~     study condition. The control condition group will be cultured at 37 degrees Celsius, the~     current standard of care. The study group will be cultured at 36 degrees Celsius. All other~     culture conditions will be kept identical and embryos will be assessed on day 3 and day 5 of~     development.~      On day 5, all well-developed blastocysts will undergo biopsy for Comprehensive Chromosomal~     Screening (CCS), which will evaluate the chromosomal normalcy of the embryo . Patients will~     undergo transfer on the morning of day 6 and the highest quality, chromosomally normal embryo~     from each group (the 36 degree cultured embryos and the 37 degree cultured embryos) will be~     transferred. If only 1 embryo is available for transfer, the patient will have a single~     embryo transfer.~      All embryos available for cryopreservation will undergo biopsy for CCS before being frozen.~     Some arrested embryos from each temperature group will also undergo genetic analysis to~     evaluate chromosomal normalcy or mosaicism.~      The female patient will undergo a blood draw at 9 weeks gestation and buccal swabs will be~     obtained from the infant(s) after birth.~   "
157382|NCT01506076|"~     The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg~     with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory~     investigations and assess relative safety and tolerance, under fasting conditions.~   "
157383|NCT01506063|"~     The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg~     with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory~     investigations and assess relative safety and tolerance, under fed conditions.~   "
157384|NCT01506050|"~     This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence~     study.~   "
157385|NCT01506037|"~     This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence~     study.~   "
157386|NCT01506024|"~     The aim of the present study is to explore the most efficient surgical approach in total hip~     replacement in short and long term when concerning strength, functionality and postoperative~     complications.~      The objective is to register muscular strength, hip joint functionality/mobilisation and~     complications after total hip arthroplasty (THA) performed by the direct lateral approach~     (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified~     Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS).~      The primary working hypothesis is that due to a minimal dissection and reduced trauma in the~     muscles, patients will tolerate early hospital discharge better after the AA than the PA and~     the DLA. Patients in the AA group are also thought to be more active and maintain muscular~     strength and hip joint functionality/mobilisation better than patients in the lateral group.~   "
157387|NCT01506011|"~     The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10~     mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical~     status, adverse events and laboratory investigations and assess relative safety and tolerance~     under fasting conditions~   "
157388|NCT01505998|"~     The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10~     mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical~     status, adverse events and laboratory investigations and assess relative safety and tolerance~     under fed conditions.~   "
157389|NCT01505985|"~     Senior hip fracture patients are the most vulnerable to malnutrition and protein deficiency.~     Low protein intake, like vitamin D deficiency, contribute to an increased risk for hip~     fracture. Notably, several clinical trials with protein supplementation in senior hip~     fracture patients resulted in fewer deaths, shorter hospital stay, and a higher likelihood of~     return to independent living. The proposal is to test the effect of an oral nutritional~     supplement (ONS) which has been designed to meet the specific nutrient needs of senior bone~     and muscle health. The hypothesis is that this ONS will improve functional recovery after hip~     fracture (as measured by Short Physical Performance Battery (SPPB)), improve quality of life,~     improve muscle mass, and- decrease falls and hospital re-admission after hip fracture.~   "
157390|NCT01505972|"~     The attendance rate to population based primary screening colonoscopy within NordICC trial~     (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%.~     The aim of this study is to compare the effect of two different time schedules for sending~     invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening~     naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive~     invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO~     group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are~     participation in screening colonoscopy within 6 months from the date of invitation, response~     and acceptance rate before sending a reminder. The study is powered to detect 7% difference~     in participation in screening colonoscopy.~   "
157391|NCT01505959|"~     Targeted population:~      Sleep apnea patients at high cardiovascular risk newly treated by CPAP~      Hypothesis:~      Improvement in blood pressure after 6 months of CPAP treatment might be greater in the~     telemonitoring arm compared to usual CPAP care.~      Main goal:~      To compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular~     risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated~     follow-up based on a telemonitoring web platform.~   "
157392|NCT01505946|"~     This is an observational, prospective, longitudinal, multicenter, cohort study designed with~     the scope to verify whether or not TGA may predict effectiveness of different FVIII~     concentrates class (devoid or rich of VWF) in patient affected by severe or moderately severe~     inherited haemophilia A and inhibitors.~   "
176991|NCT01248468|"~     The main purpose of this study is to compare the efficacy and safety of aspirin,~     acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of~     migraine.~   "
157393|NCT01505933|"~     Sedation is required in infants and children to successfully complete MRI while maintaining~     respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk~     during MRI examination. Therefore, appropriate drugs need to be selected, administered, and~     titrated to achieve these objectives. Propofol is commonly used for sedation in children in~     the MRI setting because of its predictability, rapid onset, and offset of action.~     Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and~     respiratory stability. The rationale of this research is to assess the effect of these drugs~     on the upper airway and validate their use in children with upper airway disorders.~   "
157394|NCT01505920|"~     Loop Electrosurgical Excision Procedure (LEEP) is a widely used minor surgical procedure for~     diagnosis and treatment of cervical intraepithelial neoplasia. During the procedure, several~     methods have been proposed to reducing pain including submucosal block, paracervical block,~     and oral analgesics. Submucosal (underneath the lining of the cervix) injection of lidocaine~     appeared to be the most common methods used. However, from the investigators experience,~     there is significant pain associated with the injection itself.~      Lidocaine spray is an effective measure for pain control during minor gastrointestinal and~     otolaryngological procedures. It is simple without pain related to application.~      An objective of this study is to examine effectiveness of lidocaine spray versus lidocaine~     submucosal injection by comparing pain scores at various stages of the LEEP procedure.~   "
157395|NCT01505907|"~     The primary objective of this dose escalation study is to examine the safety, tolerability,~     and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy~     male volunteers. This study may evaluate five (5) dose levels of CXB909; however, the number~     of dose levels, as well as the dosages, may be adjusted after evaluation of in-study analysis~     of the safety, tolerability, and pharmacokinetic data. This study will attempt to identify~     the maximum tolerated single dose of CXB909.~   "
157396|NCT01505894|"~     The primary objective of this trial was to investigate safety and tolerability of multiple~     doses of BI 409306 in healthy young and elderly volunteers.~      The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple~     doses of BI 409306 in healthy young and elderly volunteers~   "
157397|NCT01505881|"~     To collect additional data relating to safety and indicators of efficacy for patients who~     have participated in the 1160.113 study.~   "
157398|NCT01505868|"~     This clinical research study is made up of 2 groups and 2 phases. The goal of Phase 1 of this~     study is to learn the highest tolerated dose of the combination of cabazitaxel, carboplatin,~     and prednisone that can be given to patients with metastatic CRPC.~      The goal of Phase 2 of this study is to learn if adding cabazitaxel to the combination of~     carboplatin and prednisone affects how the disease is controlled in patients with metastatic~     CRPC.~      In both of these phases, the drug combinations will be compared to cabazitaxel alone. The~     safety of the drug combinations will be studied in both phases and groups.~      This is an investigational study. Cabazitaxel, carboplatin, and prednisone are FDA approved~     and commercially available. The use of these drugs in combination for the treatment of~     prostate cancer is investigational.~      Up to 178 patients will be enrolled in this study. Up to 178 will be enrolled at MD Anderson.~   "
157399|NCT01505855|"~     A growing number of patients with Crohn's disease are treated with immunosuppressive agents,~     such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have~     indicated that immunosuppressive treatment may impair the immunological response to~     pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and~     Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific~     disease, such as Crohn's disease. In addition, predictive factors affecting impaired response~     following pneumococcal vaccination have not clearly evaluated in patients with Crohn's~     disease. In this study, patients with Crohn's disease will be assessed for serological~     response to pneumococcal vaccination. Further, potential predictive factors that impact on~     vaccination outcomes and adverse events related to vaccination will be evaluated.~   "
157400|NCT01505842|"~     Patients with longstanding ulcerative colitis or crohn's disease in the large bowel have an~     increased risk of developing cancer. The purpose of this study is to determine if visualizing~     of the mucosa in details using a dye spray (indigo-carmine) will result in detection of more~     abnormalities than conventional colonoscopy without dye spray.~   "
157401|NCT01505829|"~     This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring~     treatment response in ovarian cancer metastases and assess its potential in monitoring~     treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across~     multiple centres and platforms, assessing reproducibility of the measurement in patients~     planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker~     in patients with platinum-sensitive relapse due to receive therapy with carboplatin. Scanning~     measurements will be correlated with histopathological markers in tumour samples in order to~     link the biomarker with response mechanisms.~   "
157402|NCT01505816|"~     This prospective nonrandomized study comprised patients with cataract, corneal astigmatism,~     and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric Intraocular~     Lens will be implanted in the capsular bag. Three months postoperatively, distance,~     intermediate, and near visual acuities; spherical equivalent; residual refractive~     astigmatism; defocus curve; and contrast sensitivity will be evaluated. A~     patient-satisfaction and visual phenomena questionnaire will also be administered.~   "
157403|NCT01505803|"~     Diabetes Mellitus (DM) is a major risk factor for cardiovascular disease, with 50% of~     diabetes-associated deaths being attributed to cardiovascular complications. The~     characterising features of DM include: the presence of chronic hyperglycaemia, consequent~     upon decreased secretion or action of insulin; dyslipidaemia; and enhanced levels of~     oxidative stress and inflammation. Zinc and omega 3 polyunsaturated fatty acids have been~     shown to influence each of these outcomes via several mechanisms. This pilot study will~     examine the effect of nutritional supplements containing zinc and omega 3 on these outcomes~     in a population with type 2 DM.~   "
157426|NCT01505504|"~     Weight loss is a frequent problem associated with Alzheimers disease (AD). Mirtazapine has~     weight loss as a frequent side effect.~      The aim of this retrospective study is to check whether mirtazapine 30 mg (once daily) can~     counteract weight loss in patients with AD or mixed dementia (AD + vascular).~   "
157404|NCT01505790|"~     Acute coronary syndromes are related to the development of a platelet derived thrombus on a~     ruptured coronary atheroma. Use of dual antiplatelet therapy aspirin-thienopyridine a~     significantly reduced the risk of major adverse cardiovascular events (MACE) after~     percutaneous coronary intervention (PCI). However despite these therapeutic innovations, the~     rate of MACE in patients treated using PCI and particularly in those suffering of an acute~     coronary syndrome is around 5% in randomized trials. Within the factors associated with MACE,~     high on treatment platelet reactivity following clopidogrel loading dose has been identified~     as a key factor. In fact it is widely recognized that there is a large inter individual~     variability in clopidogrel responsiveness. In addition several authors have demonstrated a~     strong link between high on treatment platelet reactivity following clopidogrel loading dose~     and the occurrence of post PCI MACE. Vasodilator Phosphoprotein index measurement (VASP~     index) enables a reproducible, standardized and specific assessment of clopidogrel~     responsiveness.~      The investigators previous works have demonstrated that a VASP index ≥ 50% had a high~     negative predictive value for post PCI MACE in patients undergoing PCI and that tailored~     clopidogrel loading dose in order to obtain a VASP index < 50% before PCI resulted in a~     reduction in the rate of post PCI MACE.~      Prasugrel is a new generation thienopyridine with a faster and more powerful anti platelet~     effect compared to clopidogrel. It was shown to be superior to clopidogrel to reduce post PCI~     MACE in acute coronary syndromes. However in this randomized trial prasugrel achieved an~     excessive blockade of platelet reactivity responsible for a significant increase in bleeding~     events in some patients and an insufficient blockade in up to 325% of the remaining patients.~      Therefore the investigators hypothesized that a strategy of individually tailored loading and~     maintenance dose of clopidogrel may be superior to prasugrel standard therapy in achieving an~     optimal platelet reactivity inhibition in acute coronary syndrome patients undergoing PCI.~   "
157405|NCT01505777|"~     The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and~     Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.~   "
157406|NCT01505764|"~     Cancer is often coupled with a condition called cachexia. In this condition, individuals~     continue to lose weight and lean body mass, which means their muscles are getting smaller and~     weaker. Studies have shown that cancer patients who are losing weight often are responding~     poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy.~     Also, people may not want to eat. To date, there are no approved treatments available for~     this condition.~      This study is going to study the benefits of the use of the study drug, Anamorelin~     hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies~     done before with the study drug have shown that the drug can help the cachectic condition.~     The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl~     compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including~     measurements of body potassium and nitrogen stores.~      In addition to the above, the study will also assess the effect of the study drug on handgrip~     strength, body weight, lean muscle mass, quality of life, appetite & food intake, certain~     blood markers, energy expenditure (the amount of energy participants burn), functional~     performance, safety and tolerability of Anamorelin HCl.~   "
157407|NCT01505751|"~     G9a protein was approved to be highly associated with recurrence of breast cancer, gastric~     cancer, hepatocellular cancer, prostate cancer and lung cancer. Therefore, the aim of this~     study was to clarify the association and G9a protein and cervical cancer by analyzing the~     immunohistochemical staining of G9a protein to the histopathologic specimen of cervical~     cancer and clinical data.~   "
157408|NCT01505738|"~     The amount and species of bacteria have been shown to have an effect in wound infections in~     several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery~     of facial area). In vascular surgery, wound infections are a common and expensive~     complication. The aim of the present study is to investigate the prevalence of bacteria in~     vascular surgery wounds perioperatively, and determine whether is correlates with the~     incidence of wound infections postoperatively.~   "
157409|NCT01505725|"~     Background:~      - Researchers have been studying behavioral components of nicotine addiction by looking at~     how drugs have a reinforcing effect, connecting the stimulation provided by the drug~     (nicotine) to the behavior that produces it (smoking). Based on previous studies, researchers~     are interested in learning more about how nicotine affects current smokers' responses to~     psychological tests and smoking-related cues, and in studying whether certain kinds of~     genetic background may affect smokers' responses to these kinds of studies.~      Objectives:~        -  To compare the effect of nicotine versus denicotinized cigarettes during specific~          psychological tests.~        -  To compare the effects of smoking cues versus neutral cues on craving, mood, and~          autonomic response.~        -  To study the effect of genes on nicotine reinforcement and smoking-cue reactivity.~      Eligibility:~      - Individuals between 18 and 64 years of age who are current smokers (at least 10 cigarettes~     per day for at least 1 year) and are not currently interested in reducing their smoking or~     seeking treatment for tobacco dependence.~      Design:~        -  Pilot session:~        -  Participants will practice smoking using the measuring equipment that will be used in~          the study.~        -  After successful practice, participants will read or listen to music for 1 hour, during~          which they are not allowed to smoke.~        -  After the 1-hour period, participants will sample study cigarettes that have different~          levels of nicotine, and will be asked to guess whether the cigarettes are normal study~          cigarettes or denicotinized cigarettes.~        -  Baseline session:~        -  Blood, urine, and breath samples will be taken at the start of the session.~        -  Participants will smoke part of an initial cigarette, and then will read or listen to~          music for 1 hour, during which they are not allowed to smoke.~        -  After the 1-hour period, participants will give another breath sample and will complete~          questionnaires about mood and concentration levels.~        -  Trial sessions:~        -  Participants will smoke study cigarettes, and will be asked to either respond to~          questions about perceived nicotine levels in the cigarettes or press a lever for the~          chance to be rewarded with additional puffs of the cigarette. After the session,~          participants will give another breath sample and will complete questionnaires about mood~          and concentration levels.~        -  Participants will also participate in cue-reactivity sessions to test the body's~          physiological response to smoking cues (a pack of cigarettes) and neutral cues (a pack~          of unsharpened pencils). After the session, participants will complete questionnaires on~          mood and concentration 15, 30, 45, and 60 minutes after the session.~        -  At the conclusion of the last experimental session, participants will discuss the study~          with researchers, and may receive a referral list of smoking treatment programs.~   "
157410|NCT01505712|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors find better ways to treat cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     Hodgkin lymphoma enrolled on ECOG-2496 clinical trial.~   "
157411|NCT01505699|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in samples from patients with acute~     lymphoblastic leukemia enrolled on ECOG-2993 clinical trial.~   "
157412|NCT01505686|"~     MRI imaging in clinically evident inguinal hernia is not routinely used. In other painful~     inguinal conditions (such as sportsmans hernia) inflammatory changes have been detected. The~     aim of the present study is to determine, whether similar inflammatory changes can be~     detected with MRI scan in inguinal hernia. Also, patient questionaires are used~     preoperatively and postoperatively to determine, if preoperative pain scores can be used as a~     predictive value for postoperative prolonged pain/neuralgia.~   "
157413|NCT01505673|"~     The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a~     high-dose insulin regimen (>1.8 units/kg/day) in patients with uncontrolled (HbA1c >7.5%)~     type 2 diabetes mellitus will improve blood sugar control.~      It also evaluates the effect of liraglutide on liver and pancreatic fat content, explores the~     mechanism of blood sugar improvement by assessing weight and pancreatic hormone release, and~     assesses blood pressure, lipid profile, and liver function. Finally it will look at patient~     quality of life and safety.~   "
157427|NCT01505491|"~     This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to~     establish pharmacokinetic equivalence of BI 695501 to adalimumab.~   "
157414|NCT01505660|"~     Among HIV-infected patients, adherence to antiretroviral medications is one of the most~     important determinants of clinical outcomes including viral suppression, viral resistance,~     disease progression, and death. Unfortunately poor adherence among patients with HIV is very~     common, mean levels of adherence in clinical cohorts are 60-75% or less. Alcohol, drug abuse,~     and mental illness particularly depression symptoms are key predictors of poor adherence,~     common among HIV-infected individuals, and important to identify and treat among nonadherent~     patients. This study will examine the ability of patient reported outcomes (PROs) and a~     targeted care management approach to improve clinical outcomes with a randomized controlled~     trial (RCT) in routine clinical care of patients with HIV. The investigators will determine~     whether healthcare delivery team notification of PROs including antiretroviral medication~     adherence and barriers of adherence such as depression and substance abuse along with~     tailored intervention recommendations and targeted care management leads to improvement in~     both process and clinical outcomes including patient-reported outcomes. The investigators~     will examine process outcomes such as use of clinic support services, and patient outcomes~     such as improvement in adherence, substance use, depression, and HIV-1 RNA levels.~   "
157415|NCT01505647|"~     This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process~     [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to~     ZOSTAVAX™.~   "
157416|NCT01505634|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125~     mg or 250 mg doses of MK-7655 to imipenem/cilastatin in adults 18 years or older with~     complicated urinary tract infection (cUTI). The primary hypothesis is that the MK-7655 +~     imipenem/cilastatin treatment regimen is non-inferior to imipenem/cilastatin with respect to~     the proportion of participants with a favorable microbiological response at completion of~     intravenous (IV) study therapy.~   "
157417|NCT01505621|"~     Accumulation of damaged proteins is thought to underlie many degenerative conditions,~     including aging, diabetes, Alzheimer's disease, cataracts, and others. Over time, proteins~     can be irreversibly damaged by a variety of factors, such as reactive oxygen species, and~     without timely degradation they can accumulate and aggregate. We believe this can contribute~     to the development of chronic degenerative disorders.~      The purpose of this study is to develop a novel methodology for measuring protein~     accumulation and test it in two groups of people: young (18-30 years) and old (≥65 years).~     This methodology will require that people drink a solution of essential amino acids that~     includes isotopically labeled L[ring-13C6]phenylalanine. We will then collect blood and~     muscle samples, to isolate plasma and skeletal muscle proteins. Participants will return to~     the study center four more times on a weekly interval.~      We hypothesize that older proteins, which persisted in circulation and accumulated over time,~     will have a higher degree of post-translational oxidative damage than newly synthesized~     proteins.~   "
157418|NCT01505608|"~     The purpose of this research study is to evaluate a new investigational drug (TPI 287) for~     early relapsed neuroblastoma. An investigational drug is one that has not yet been approved~     by the Food and Drug Administration. This investigational drug is called TPI 287. This study~     will look at the tumor's response to the study drug, TPI 287, in combination with Irinotecan~     and Temozolomide versus the combination of Irinotecan and Temozolomide alone. This study will~     also evaluate the safety and tolerability of the study drug, TPI 287.~   "
157419|NCT01505595|"~     Proprioceptive weighting changes may explain differences in postural control performance.~     Deficits in proprioception are found in a subgroup of patients with low back pain.~      The aim of the study is to clarify whether proprioceptive training has a positive effect on~     proprioceptive postural control in individuals with recurrent low back pain.~   "
157420|NCT01505582|"~     Proprioceptive weighting changes may explain differences in postural control performance. In~     addition, the respiratory movement has a disturbing effect on postural balance. Postural~     balance seems to be impaired in individuals with respiratory disorders. Besides the essential~     role of respiration, the diaphragm may also play an important role in the control of the~     trunk and postural balance. Deficits in proprioception are found in a subgroup of patients~     with low back pain. In addition, disorders of respiration have been identified as strongly~     related to low back pain.~      The aim of the study is to clarify whether inspiratory muscle training has a positive effect~     on proprioceptive postural control in individuals with recurrent low back pain.~   "
157421|NCT01505569|"~     This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS~     tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or~     carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral~     blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation~     therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood~     stem cell transplant will be given for 3 cycles.~   "
157422|NCT01505556|"~     Proprioceptive weighting changes may explain differences in postural control performance. In~     addition, the respiratory movement has a disturbing effect on postural balance. Postural~     balance seems to be impaired in individuals with respiratory disorders. Increased risk of~     falling is reported in individuals with chronic obstructive pulmonary disease. Besides the~     essential role of respiration, the diaphragm may also play an important role in the control~     of the trunk and postural balance.~      The aim of the study is to clarify whether proprioceptive postural control is impaired in~     individuals with diaphragm paresis.~   "
157423|NCT01505543|"~     Proprioceptive weighting changes may explain differences in postural control performance. In~     addition, the respiratory movement has a disturbing effect on postural balance. Postural~     balance seems to be impaired in individuals with respiratory disorders. Increased risk of~     falling is reported in individuals with chronic obstructive pulmonary disease. Besides the~     essential role of respiration, the diaphragm may also play an important role in the control~     of the trunk and postural balance.~      The aim of the study is to clarify whether proprioceptive postural control is impaired in~     individuals with chronic obstructive pulmonary disease.~   "
157424|NCT01505530|"~     This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in~     participants with locally advanced/inoperable or metastatic pancreatic cancer, and will~     investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.~   "
177467|NCT01242202|"~     This study is to evaluate long-term safety and efficacy after concomitant administration of~     ASP1941 and α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus.~   "
157428|NCT01505478|"~     The investigators will conduct a prospective cohort study to compare an automated sepsis~     severity score to a conventional clinical prediction rule to risk stratify patients admitted~     from the emergency department (ED) with suspected infection for 28 day in-hospital mortality.~   "
157429|NCT01505465|"~     Pain, confusion, and breaks in normal sleep cycles have been challenges commonly faced by~     patients after undergoing joint surgeries. To address these issues, melatonin, an inexpensive~     over-the-counter supplement, has shown in previous to help manage sleep disorders, prevent~     and treat post-operative confusion in patients over 70 years of age, and reduce pain. The~     purpose of this study is to establish whether melatonin can aid in reducing pain and~     post-operative confusion and improve sleep quality after total knee replacement~   "
157430|NCT01505452|"~     The purpose of this study is to clinically demonstrate a phenomenon of measurement error that~     can occur during placement of a specific type of total knee replacement prosthesis (single~     radius femoral component) using a certain type of surgical technique (flexion/extension gap~     balancing).~   "
157431|NCT01505439|"~     This study is to investigate the effects of solifenacin on urgency urinary incontinence~     symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically~     significant stress urinary incontinence accompanied by urgency urinary incontinence.~   "
157432|NCT01505426|"~     To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian~     subjects with type 2 diabetes mellitus.~   "
157433|NCT01505413|"~     Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth~     factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine~     kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong~     case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the~     addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in~     advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with oxaliplatin~     is superior to gemcitabine alone in terms of progression free survival and response rate in~     one phase III trial (Louvet et al). Taken together, combining erlotinib with gemcitabine and~     oxaliplatin may further improve the overall survival and clinical benefit of advanced~     pancreatic cancer.~   "
157434|NCT01505400|"~     Substantial progress has been made in the treatment of cancer through the use of targeted~     therapies, but what works for one patient might not work for another patient. Certain drugs~     are now being developed that target specific molecules in the body that are believed to be~     part of the disease.~      Biomarkers are specific characteristics of the cancer that may help provide prognostic~     information (i.e. how well patients will be regardless of the treatments given) or help~     predict sensitivity or resistance to a specific treatment.~      The study will collect archival tumor samples (previously collected biopsy or surgical tumor~     samples) to provide biomarker data about a patient's cancer, in order to help their~     physicians to identify which clinical trials of molecularly targeted therapies may be most~     appropriate for the patient in the future.~   "
157435|NCT01505387|"~     The effect of Litramine on weight loss has previously been studied during a 12-week~     intervention period with promising results. The present study looks into the effect of weight~     maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.~   "
157436|NCT01505374|"~     Currently, the regional anesthetic standard of care for total knee replacement surgery is~     combined spinal/epidural to provide long-lasting pain relief with or without a femoral nerve~     block (FNB). The femoral nerve block refers to a technique that your anesthesiologist can use~     to numb the thigh muscle for approximately 18 hours after surgery. While this technique~     offers significant pain relief, it is possible it may cause muscle weakness and increase~     patients' recovery times. Hence there is a need for an alterative anesthetic technique, one~     that may help minimize postoperative pain as effectively as a femoral nerve block, while not~     causing weakness of the thigh muscle.~      The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it~     is hypothesized by blocking or anesthetizing the saphenous nerve with local anesthetic~     closer to where it branches off, the area around and below the knee will feel numb. Yet~     unlike the femoral nerve block, the thigh muscle itself will still be able to function.~      For patients undergoing two total knee replacements at one time or bilateral total knee~     replacement, they will be randomly assigned to receive a femoral nerve block on one leg and a~     saphenous block on the other. Pain levels will be measured and thigh muscle strength will be~     tested using a dynamometer before surgery, 6-8 hours following anesthesia administration, and~     on postoperative days 1 and 2.~   "
157437|NCT01505361|"~     In previous studies, the investigators have seen that carefully-selected Lactobacillus~     strains are a good alternative to antibiotics for the treatment of lactational mastitis. The~     objective of this new study is to check if they can also have a preventive role when~     administered to women with a history of mastitis with one or more previous infants. Since the~     investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting~     intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of~     resistant bacteria), the investigators would also like to test if administration of the~     strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a~     mastitis-predisposing factor would de avoid.~   "
157438|NCT01505348|"~     This study examined changes in bone metabolism (markers of bone turnover, calcium metabolism)~     with a bout of acute treadmill running preceded by either a single, mixed meal or an~     overnight fast.~   "
157439|NCT01505335|"~     The purpose of this human clinical trial is to validate the accuracy of Jetguide® US device~     in detecting the inferior alveolar canal (IAC) and to compare it to measurements performed on~     computerized tomography images.~   "
157440|NCT01505322|"~     Can pain impairment of daily activities be shown to be procedure specific, and thus used as~     an alternative to pain scoring.~   "
157441|NCT01505309|"~     The purpose of this study is to investigate the short to mid term efficacy and safety of~     Thoracic Endovascular Aortic Repair (TEVAR) in patients who had aortic lesions, such as~     descending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type B dissection, dissection with~     primary tear located in the aortic arch, et al.~   "
157442|NCT01505296|"~     The objective is to compare the progression of Atrial Fib (AF) burden by continuous~     monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation~     (PVI) versus anti-arrhythmic drug (AAD) therapy.~   "
157443|NCT01505283|"~     There are many methods used for the assessment of pain in the area of anesthesia including~     heart rate variability which reflects the influence of the autonomic nervous system on the~     heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during~     anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious~     patients with a comparison of ANI with the measurement of pain by a visual analog scale~     (VAS).~      Evaluation of ANI is performed just before epidural catheter insertion and during the 10~     first minutes after saline, sufentanil or lidocaine epidural administration.~   "
157444|NCT01505270|"~     It is known that several psychological and medical comorbidities are frequently found among~     children suffering from autistic spectrum disorders. Our aim is to investigate which~     comorbidities are most common among those children and whether there are differences among~     the different ethnic groups found in Israel.~   "
157445|NCT01505257|"~     Delirium (acute confusion) is common and costly in persons with dementia, resulting in longer~     hospital stays, more complications, and greater functional decline. This research tests the~     use of the electronic health record, education, and regular feedback to nurses to improve~     detection and management of delirium. Ultimately, findings will direct ways to improve acute~     care of this vulnerable population.~   "
157446|NCT01505244|"~     Children in the U.S. exhibit low levels of physical activity. In addition to the overall~     physical health and fitness benefits with increasing levels of physical activity,~     improvements in academic performance, mental cognition, and behavior may occur. Despite these~     benefits, opportunities for children to participate in physical activity are being reduced,~     particularly in schools.~      The proposed study is a pilot program with approximately 100 children ages 7-11 years~     expected to participate. All study participants will partake in a testing and measures~     session which will include body composition measures, nutrition and physical activity~     questionnaires, and curriculum-based measures. Following the first testing and measures~     session, 50 of the 100 children will participate in a 10-12 week, before-school, moderate to~     vigorous physical activity (MVPA) program. This program will consist of non-competitive, MVPA~     and occur 3 days/week at their school. Subsequent to the physical activity program, all 100~     children will then participate in a follow-up testing and measures session.~      The objective of this proposed pilot study is to determine the feasibility of implementing a~     before-school, physical activity program as well as explore the effect the program may have~     on academic performance and health measures.~   "
157447|NCT01505231|"~     Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery,~     with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory~     phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can~     be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The~     investigators hypothesized that the use of arginine vasopressin would be more effective on~     treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end~     point of mortality and severe morbidity.~   "
157448|NCT01505218|"~     Propofol sedation with opioids is used for endoscopic retrograde cholangiopancreatography~     (ERCP). Combination of sedatives and opioids is associated with increased~     morbidity/mortality. Delivery of only propofol using a patient-controlled delivery system~     (patient-controlled sedation, PCS) could be an alternative for this purpose. Comparative~     studies with PCS for ERCP are few. Therefore, the main objective of this randomized~     controlled trial was to compare propofol PCS to sedation managed by nurse anaesthetists~     during ERCP.~   "
157449|NCT01505205|"~     Mutations of tumor-related genes are dynamic. Gastrointestinal stromal tumor cells often are~     obviously more invasive in case of recurrence. The great majority of relapses may be~     associated with secondary mutation in the GIST related genes. Full gene sequences of~     c-KIT、PDGFRA and DOG1, which is extracted from the specimen cells of repeated surgical~     resection or biopsy tissue in GIST patients with postoperative recurrence, are analyzed with~     the screening-sequencing approach, in order to investigate the characteristics and variations~     associated with the different gene mutations of c-KIT、PDGFRA and DOG1 in GIST patients and be~     likely to find out the evolutionary pattern, try to learn the facts about the effect of~     tyrosine kinase inhibitors on the GIST related genes, make a survey of any association of~     c-KIT、PDGFRA and DOG1 gene mutations and provide the basis for seeking molecular marker of~     GIST for monitoring course of disease, and offer a theoretical basis and new therapeutic~     strategies for application of clinical treatment.~   "
157450|NCT01505192|"~     Aim of this study is to determine the physiological reference individual values (RI) of~     maternal continuous SpHb immediately after delivery in the post-partum period (continuous~     monitoring up to 2 hours after delivery) in order to establish the physiological Hb~     variations in response to the physiological blood loss due to delivery.~      During labor all parturients will be tested for standard Laboratory Hb and monitored for at~     least 30 minutes with SpHb monitoring equipment (Radical-7™ Pulse CO-Oximeter and Rainbow~     DiSposable™ Adult Adhesive Sensor), and these values will be considered to be the baseline~     values.~      Immediately after spontaneous vaginal delivery, venous blood sample will be taken for Hb~     determination and Radical 7 equipment for SpHb will be connected to the patient's finger and~     will be recorded for at least two hours after delivery. At the end of this period of~     observation a venous blood sample will be taken for Hb determination. Additional measurements~     of both SpHb and Lab Hb will be performed 24 hours after delivery.~   "
157451|NCT01505179|"~     The purpose of this study is to determine whether treatment with Ranolazine will improve~     exercise capacity in patients with Heart Failure with preserved left ventricular ejection~     fraction.~   "
157466|NCT01504984|"~     The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by~     comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T~     (400mg) when administered a single-dose to healthy male volunteers.~   "
157467|NCT01504971|"~     Aim of this study is to compare the efficacy of narrow band imaging (NBI) and~     autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux~     that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the~     diagnosis of gastroesophageal reflux disease (GERD).~   "
157468|NCT01504958|"~     This study looks at the potential benefits of combining cognitive training (mental exercises)~     together with transcranial magnetic stimulation (also known as TMS) to see if this can make a~     difference in the condition of people with Alzheimer's disease by improving their disease and~     the cognitive decline that goes along with it.~   "
157452|NCT01505166|"~     Preliminary studies with a variety of vaccines suggest target accessibility (potential~     immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to~     overcome limitations of immunostimulatory cancer vaccines, Gradalis has designed a novel~     autologous vaccine to address inability to fully identify cancer associated antigens, antigen~     recognition by the immune system (i.e. antigen-->immunogen), effector potency, and~     cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer~     vaccines, we designed a novel dual-modulatory autologous whole cell vaccine, Vigil™,~     incorporating the rhGMCSF transgene and the bifunctional shRNAfurin (to block proprotein~     conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer~     associated antigens, 2) effect antigen recognition by the immune system, 3) enhance effector~     potency, and 4) subvert endogenous cancer-induced immune resistance. We have also completed~     the Phase I assessment of Vigil™ vaccine in 30 advanced solid tumor patients (1.0 x 10^7~     cells/injection/month for a maximum of 12 vaccinations) who have not experienced any~     significant adverse effects following 144 vaccinations, including 6 patients with colorectal~     carcinoma. Plasmid functionality, immune biomarker response, and preliminary evidence of~     anticancer activity have been observed. This is a two-part Phase II study of the Vigil™~     autologous vaccine. Six patients will be enrolled into the Part 1 of the study to receive~     intradermal autologous Vigil™ cancer vaccine (1.0 x 10^7 cells/injection; maximum of 12~     vaccinations). Part 2 of the study will be a randomized Phase II study of sandwich or~     adjuvant chemotherapy and intradermal autologous Vigil™ cancer vaccine (1.0 x 10^7~     cells/injection; maximum of 12 vaccinations) versus sandwich or adjuvant chemotherapy and~     placebo in patients with colorectal carcinoma with either synchronous or metachronous liver~     metastases (CLM +/= pulmonary metastases) following resection +/= ablation with curative~     intent.Sandwich therapy indicates a combination of both pre-operative and postoperative~     chemotherapy as opposed to neo-adjuvant (all chemotherapy prior to surgery) or adjuvant (all~     chemotherapy following surgery) therapy. A minimum harvest aliquot to produce 4 monthly~     injections will be required for entry into the study. Patients in whom insufficient tissue~     (<4 doses) is collected or whose vaccine fails manufacturing release criteria will not~     receive vaccine.~   "
157453|NCT01505153|"~     This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar~     invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single intratumoral~     (IT) injection. Patients with superficially accessible advanced cancer following prior~     therapies will be entered into the study following a modified dose escalation design based on~     the demonstrated safety of our previous clinical experience (BB-IND 13744) with the same~     liposome and vector DNA backbone expressing a different transgene (of which doses up to 7 mg~     DNA IV/single dose have been administered). Patients will accrue in 4-patient escalation~     cohorts using a modified Fibronacci escalation schema (100%-50%-33%-33%) at a starting~     intratumoral dose of 0.010 mg/kg of DNA through a dose of 0.053 mg/kg DNA intratumoral /~     single dose. Should a single, but not more than two (2), ≥ Grade 3 Dose Limiting Toxicity~     (DLT) occur in any cohort, following mandated review (see below) an additional two (2)~     patients will be accrued at that dose (total of six). If more than one ≥ Grade 3 toxicity~     occurs in any cohort, the preceding dose cohort will be expanded to six (from four) and if <~     2/6 patients experience ≥ Grade 3 toxicity, that dose will be the Phase II recommended dose.~     Should no ≥ Grade 3 toxicity occur in any cohort (other than Grade 3 local injection site~     reaction), an additional two (2) patients will be treated at 0.053 mg/kg DNA intratumoral /~     single dose.~   "
157454|NCT01505140|"~     Walnuts as a whole food contain polyunsaturated fatty acids, anti-oxidants, and other~     nutrients essential to sperm development and function. This randomized controlled trial~     sought to determine if a Western style diet supplemented with walnuts would improve sperm~     quality as a predictor of male fertility.~   "
157455|NCT01505127|"~     The purpose of this study is to confirm the efficacy of triple therapy with TAK-438,~     Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to~     triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive~     patients with scarred gastric or duodenal ulcers.~   "
157456|NCT01505114|"~     Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of~     antiretroviral (ARV) medications before exposure to HIV. This study will evaluate the safety~     and tolerability of four ARV regimens in preventing HIV infection in men who have sex with~     men who may be at risk of getting HIV infection through sex and women who may be at risk of~     getting HIV infection through sex. The four ARV regimens being evaluated are maraviroc (MVC),~     MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF plus FTC.~     The MVC-containing arms will be compared to TDF/FTC alone and in combination.~   "
157457|NCT01505101|"~     Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk~     of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of~     opioids may result in hyperalgesia, which exacerbates opioid craving and consumption.~     Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes,~     and substance use. The investigators hypothesize that relative to a support group control~     condition, participation in a novel mindfulness-oriented cognitive intervention,~     Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and~     decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients~     receiving opioid therapy.~   "
157458|NCT01505088|"~     The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with~     dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery~     System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with~     non-infectious anterior segment uveitis.~   "
157459|NCT01505075|"~     The purpose of this study is to determine the safety and efficacy of a short course of~     radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer~     currently being managed with primary androgen deprivation therapy (PADT).~   "
157460|NCT01505062|"~     To evaluate the safety and tolerability of ascending doses of subretinal injections of~     UshStat in patients with Usher syndrome type 1B.~      To evaluate for possible biological activity of UshStat.~   "
157461|NCT01505049|"~     Vaccines for human papillomavirus (HPV) have been available in the United States since 2006.~     Early studies have shown a high rate of effectiveness of these vaccines, however it is not~     known how long this protection will last. The IMAP study will look at various parts of the~     immune system and potential markers for long lived immune responses to this vaccine.~   "
157462|NCT01505036|"~     SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with~     diabetes.~   "
157463|NCT01505023|"~     The objective of this study was to test the efficacy of a partial meal replacement added with~     vitamins, minerals and inulin on weight reduction, blood lipids and micronutrients intake in~     obese Mexican women~   "
157464|NCT01505010|"~     INSPiRED is a multicenter parallel-group trial comparing usual medical treatment (control~     group) or usual medical treatment plus renal denervation (intervention). In both groups~     adherence will be monitored both before randomization and during 36 months of follow-up.~   "
157465|NCT01504997|"~     The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph~     node dissection in patients with stage Ia early gastric cancer.~   "
157469|NCT01504945|"~     Patients with a low blood count (anemia) with stable or unstable coronary artery disease~     consistently show worse clinical outcomes. It is unclear whether this association is~     confounded since anemic patients tend to be also sicker i.e. have lower ejection fractions or~     more comorbidities and this would be the reason for the worse outcomes rather than anemia.~     The coronary arteries are a unique vascular bed insofar that across the cardiac circulation~     oxygen extraction is close to maximal at rest. Thus increases in demand can only be met by~     increases in blood flow and hemoglobin concentration since oxygen extraction is maximal at~     rest. It is natural to assume that maximization of oxygen delivery in the setting of active~     coronary syndrome (ACS) is beneficial to the patient since oxygen extraction and coronary~     blood flow is fixed. In fact, in most intensive care units patients with ACS are transfused~     to a HCT of 30%. However, retrospective analysis of trial data showed at best mixed results~     in clinical outcome when patients with ACS were transfused and in fact in some studies showed~     consistently worse outcomes than non-transfused patients. Similar disappointing results have~     recently published in patient who underwent coronary artery bypass grafting (CABG).~      This study is designed to determine the effect of red blood cell (RBC) transfusion on oxygen~     consumption, cardiac, microcirculatory and endothelial function in patients with active~     coronary artery disease. For this study active coronary artery disease will be defined as the~     patient having undergone within the past 4 days of recruitment either a myocardial infarction~     due to atherothrombosis (AHA type I myocardial infarction) or surgery for coronary artery~     bypass grafting.~      In specific this study will test the hypothesis whether RBC transfusions improves cardiac and~     vascular function in patients with a hematocrit of less than 30% with active coronary artery~     disease.~      Aims of this study are to determine whether RBC transfusion in patients with active coronary~     artery disease and anemia:~        -  increases oxygen delivery to the peripheral tissues.~        -  increases whole-body oxygen consumption.~        -  decreases nitric oxide bioavailability, endothelial, microcirculatory, and myocardial~          function, and/or increases platelet aggregation~   "
157470|NCT01504932|"~     This pilot clinical trial studies freeze-dried black raspberries in preventing oral cancer~     recurrence in high-risk Appalachian patients previously treated with surgery for oral cancer.~     Chemoprevention is the use of certain drugs to keep cancer from forming. Giving freeze-dried~     black raspberries may prevent oral cancer from forming~   "
157471|NCT01504919|"~     The goal of this research study is to learn if a wellness program can help improve diet and~     physical activity levels and encourage smoking cessation in Latino individuals who are~     overweight.~   "
157472|NCT01504906|"~     The purpose of this study is to assess the effect of Cyclosporine on the blood levels of~     Ticagrelor.~   "
157473|NCT01504893|"~     The purpose of this study is to determine if a protective ventilatory strategy during~     one-lung ventilation (OLV) could reduce postoperative complications (PPCs) after~     thoracotomies or thoracoscopic pulmonary resection.~      Primary endpoint: Evaluation of Acute Lung Injury (ALI) incidence~      Secondary endpoint: postoperative outcome (hospital lenth of stay, morbidity, mortality and~     their correlation with preoperative comorbidity and surgery technique).~   "
157474|NCT01504880|"~     The purpose of this pilot study is to evaluate mitral (left atrioventricular valve) and~     tricuspid (right atrioventricular valve (AVV)) regurgitation using cardiac magnetic resonance~     imaging (CMR) as the non-invasive gold standard compared to transthoracic echocardiography~     (TTE) to evaluate measurements of the width of the regurgitation jet (vena contracta (VC)) to~     demonstrate the utility of the VC as a means to objectively evaluate atrioventricular valve~     regurgitation. In addition, feasibility and other quantitative and qualitative measures of~     regurgitation will be compared between CMR and TTE.~        -  Hypothesis 1: The ability to objectively evaluate atrioventricular valve regurgitation~          and VC width with TTE and CMR has a high feasibility rate with acceptable intra and~          inter-observer variability by two independent readers.~        -  Hypothesis 2: There will be positive correlation between the TTE measurement of the VC~          width and quantitative assessment of atrioventricular valve regurgitation by TTE and~          CMR.~        -  Hypothesis 3: There will be a positive correlation between the quantitative measurements~          of atrioventricular valve regurgitation by phase contrast velocity encoded CMR with~          quantitative values as measured by TTE.~        -  Hypothesis 4: There will be a positive correlation between qualitative assessment of~          atrioventricular valve regurgitation by CMR compared to TTE.~   "
157475|NCT01504867|"~     The primary hypothesis was that early aspirin administration will decrease the rate of~     developing acute lung injury during the first 7 days after presentation to the hospital.~   "
157476|NCT01504854|"~     Resveratrol is derived from plants and is found in highest levels in red wine and the skin of~     red grapes. A recent study reported that monthly and weekly consumption of red wine is~     associated with a lower risk of dementia. There is compelling evidence that caloric~     restriction can improve overall health by activating a class of enzymes known as Sirtuins.~     Resveratrol is a substance found in some plants that directly activates sirtuins, mimicking~     the effects of caloric restriction and may affect regulatory pathways of diseases of aging,~     including Alzheimer's disease (AD).~      In this study, people with AD will be given either Resveratrol or placebo for 12 months to~     determine whether daily resveratrol therapy is beneficial in delaying or altering the~     deterioration of memory and daily functioning. Subjects age 50 and above with a diagnosis of~     probable AD may qualify for participation in this study. A small group of 15 participants~     will be asked to take part in a more detailed 24-hour Pharmacokinetic (PK) sub-study that~     will measure resveratrol levels over a 24 hour period.~   "
157477|NCT01504841|"~     Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are widely used as part of~     combination antiretroviral therapy (ART) for infants and children, but NNRTI resistance is~     increasing, leading to treatment failure. This study will test the safety, tolerability, and~     dosing levels of etravirine (ETR), a new NNRTI.~   "
157478|NCT01504828|"~     Normal aging is characterized by altered cardiovascular function. Our preliminary data with~     MR imaging and spectroscopy in normal subjects without cardiovascular disease or hypertension~     show that age-related cardiac dysfunction is characterized initially by impaired relaxation~     of the heart (40 - 60 years), and then at > 60 years altered contraction and impaired~     myocardial energetics. For the first time, the investigators will test whether the functional~     and energetic effects of normal aging can be reversed by acutely reducing stiffness of~     peripheral blood vessels using an ACE inhibitor. This will potentially have important~     insights into how normal aging affects the heart, and how potential treatments could be used~     to attenuate this process.~   "
157479|NCT01504815|"~     This Phase III trial aims to:~      Explore the impact of pre-treatment information and radiation dose redistribution on~     locoregional control in patients with locally advanced SCCHN.~      The dose to the primary tumor with margins, based upon PET and CT information, will be~     inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards~     the edges of the irradiated area.~      To determine the toxicity of combined modality treatment (cisplatin) with standard dose~     distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous~     radiation dose distribution.~   "
177468|NCT01242176|"~     The objective of the study is to investigate the relative bioavailability of the final tablet~     formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).~   "
157480|NCT01504802|"~     It is now widespread practice to treat children with short stature with growth hormone.~     However, how an individual child will respond to growth hormone treatment is unpredictable~     and highly variable. Some children will not respond to growth hormone treatment at all.~     Currently, the only way to determine how well growth hormone therapy is working is to wait~     until they have been treated for six months and to compare the pre-treatment growth velocity~     with the growth velocity on treatment. It would be helpful to have a blood test that could be~     done shortly after starting growth hormone that could predict whether how well a child is~     responding to treatment. Such a blood test would allow endocrinologists to adjust the growth~     hormone dose (or possibly stop it altogether, if it is not working) long before the six~     months it currently takes.~      C-type natriuretic peptide (CNP) and its partner amino-terminal propeptide of CNP (NTproCNP)~     are proteins that play a critical role in regulating growth. The investigators have~     previously shown that blood levels of these proteins increase in children being treated with~     growth hormone. The investigators believe that a blood test for these proteins will be useful~     in predicting a child's response to growth hormone treatment.~      The purpose of this study is to determine when after starting growth hormone, the blood~     levels of CNP and NTproCNP start to increase.~   "
157481|NCT01504789|"~     The goal of this research study is to test an exercise program that is designed for Hispanic~     breast cancer survivors. Researchers want to learn the most effective strategies for~     promoting exercise.~   "
157482|NCT01504776|"~     The purpose of this study is to determine the safety and clinical efficacy of the combination~     of panobinostat plus bortezomib.~   "
157483|NCT01504763|"~     The purpose of this study was to assess the feasibility and effect of chair massage provided~     during working hours for nurses in an inpatient psychiatric and an outpatient pain~     rehabilitation unit and on the nurses stress related symptoms.~   "
157484|NCT01504750|"~     Rationale:~      Many study reports described benefits of natural sunlight. It is believed that artificial~     light can achieve similar benefits as sunlight and can be used to compensate for the lack of~     sunlight, for instance in north-facing hospital rooms or during wintertime.~      The most plausible paths mediating the effects of light are:~        -  the biological effect of light, relating to circadian biology and the sleep/wake-rhythm;~        -  the emotional/psychological effects of light, relating to mood/stress and the~          antidepressant action of light .~      Objective:~      The project aims to measure, evaluate and quantify the beneficial effects of a dynamic~     daylight & atmosphere experience in patient rooms for cardiovascular patients during the dark~     months of the year.~      Study design:~      The study involves an experiment in which psychological, emotional and clinical parameters of~     patients in hospital rooms with standard light situation are compared with those of patients~     in rooms with a dynamic daylight & atmosphere experience.~      Study population:~      The population includes cardiovascular patients who reside in the general cardiology~     department of the Maastricht University Hospital (18 patient beds) with an intended minimum~     length of stay of 3 days, who have given written consent.~      Intervention:~      Half of the patient rooms on the ward are equipped with special luminaires. In the ceiling,~     luminaires are installed that offer the basic lighting in the patient room that will~     automatically and gradually change in light level (100-300 lux) and color temperature~     (3000-4000 K). This so called daily rhythm light meets the EN12464-1 standard for patient~     rooms in hospitals. The same luminaires in the ceiling will also offer the light boost by~     bringing the illuminance to a level of maximal 2000 lux and 7000 K, during a period of two~     hours in the morning. Besides the ceiling luminaires, a low intensity color cove as well as~     some white LED spots are added to create a pleasant ambience in the patient room~      Main study parameters/endpoints:~      The primary study measures are length of stay and quality of recovery expressed by~     physiological, emotional and clinical parameters. Also the effect on patient satisfaction is~     determined using pre and post assessments.~   "
157485|NCT01504737|"~     SURVEY OF THE FIELD Aortic stenosis (AS) is the most common valve disease and increasing due~     to a growing elderly population. The therapy is aortic valve replacement (AVR). Studies on~     postoperative rehabilitation of AS pts are scarce. In the few studies available, a mix of~     valve diseases is presented without considering the differences in pathophysiology and the~     training regimes are not clearly described.~      PURPOSE, AIMS & HYPOTHESIS The investigators purpose is to evaluate whether a supervised~     cardiac rehabilitation program improves the objective physical capacity and quality of life~     (QoL) of patients after AVR due to AS, and compare this to patients training by their own.~     The investigators hypothesize that supervised exercise training may be a more efficient way~     of rehabilitating these patients.~      DESIGN This is a controlled randomized clinical trial comparing 12 weeks of supervised~     exercise training 3 times per week to home-based training based upon public health~     recommendations of minimum level of physical activity.~      SIGNIFICANCE & IMPLEMENTATION Positive results would support that an organized program of~     exercise training improves physical capacity and QoL in AS patients following AVR with~     potential benefit for both patients and society.~   "
157486|NCT01504724|"~     This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before~     panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and~     retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without~     macular edema.~   "
157487|NCT01504711|"~     This clinical trial studies fosaprepitant dimeglumine in preventing nausea and vomiting in~     patients with gastrointestinal cancer receiving combination chemotherapy. Antiemetic drugs,~     such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients~     treated with chemotherapy.~   "
157488|NCT01504698|"~     The purpose of this study is to determine the effect of manipulative treatment of children~     with neck and back pain. Because manipulation is the most frequently used treatment of~     musculoskeletal complaints in children, and an increasing number of Danish children see a~     chiropractor, it appears obvious to start the search for evidence by examining the effect of~     this treatment.~   "
157489|NCT01504685|"~     The purpose of the study is comparatively analyze the advantages and disadvantages of banded~     versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB).~      The outcome variables of the general study included morbidity, maximal weight loss, and late~     weight regain.~   "
157490|NCT01504672|"~     The aim of this randomized controlled study is to investigate if medication reviews performed~     by a clinical pharmacist as part of a ward team can reduce drug related problems and reduce~     readmissions to hospital among elderly patients (≥65 years) with dementia and cognitive~     failure.~      Four hundred and sixty patients will be recruited and randomized to control (usual care) and~     intervention group (enhanced service in which a pharmacist is part of the health care team).~      Six months after the last patient of the 460 has been discharged the study will be closed.~     Data about the number of readmissions and visits to the emergency room will be collected~     during the six-month follow-up and also, the costs associated with each visit or admission.~     Time until institutionalization will be compared between intervention group and control~     group.~   "
158057|NCT01497236|"~     The purpose of this study is to determine whether 14 days nutritional supplementation with~     Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection~     will prevent malnutrition and reduce the frequency of morbidity.~   "
157491|NCT01504659|"~     The investigators plan to evaluate the efficacy and safety of intranasal Ketalar (ketamine~     hydrochloride) in the treatment of primary symptom manifestations of pediatric bipolar~     disorder; Fear of Harm (FOH) phenotype. This phenotype represents those children who are most~     resistant to traditional treatments and suffer repeated hospitalizations. Primary symptoms~     include fearfulness, aggression secondary to threat, mood and/or arousal instability, and~     psychosis. In addition to evaluation of efficacy and safety, the investigators will also~     analyze whether therapeutic response depends upon the degree to which the subject fits the~     FOH phenotype.~   "
157492|NCT01504646|"~     The primary aim of this study will be to evaluate the effects of Lyprinol® supplementation on~     airway inflammation and the bronchoconstrictor response to dry air hyperpnea in individuals~     with asthma. The investigators hypothesize that Lyprinol® supplementation, compared to~     placebo, will significantly attenuate airway inflammation and hyperpnea-induced~     bronchoconstriction in asthmatic individuals.~   "
157493|NCT01504633|"~     Rationale: Review on the positive effect of long chain polyunsaturated fatty acids (LCPUFA),~     especially docosahexanoic acid (DHA), supplementation on cognitive function in human using~     randomized controlled trials (RCTs) showed that results in RCTs were mixed and inconsistent.~     It has been suggested that the effect may be subtle, which is currently difficult to detect,~     but could be significant, or there may be individual variation which mediate the effect.~      Objectives: This study aims to assess gene-nutrient inter-relation in explaining the effect~     of LCPUFAs i.e. DHA and/or iron on cognitive functioning of children <24mo in Indonesia.~     Specifically the study's objectives are: (1) to assess effect of LCPUFA (as DHA oil) and iron~     (as iron supplement) in altering gene expressions, and (2) to assess the mediating effect of~     genes involved in fatty acid and iron metabolism in improving serum LCPUFA, alpha-linolenic~     acids (ALA), DHA and cognitive function.~      Study design and study population: The study is a double-blind randomized controlled trial~     with children aged less than 24 months (window of opportunity). The study area is in East~     Lombok district, in West Nusa Tenggara province, Indonesia where nutrient intake including~     iron and presumably LCPUFA, is not optimal.~      Intervention: The study is an intervention study, consisting of four groups: DHA, iron,~     DHA+iron, and placebo (60 subjects/group = 240 subjects in total). Capsule containing 100mg/d~     DHA or its placebo and syrup containing 16mg/d iron will be given daily for 24 weeks. Before~     and after the intervention child cognition (as Bayley Mental Developmental Index or MDI~     score), serum PUFA level, iron status (haemoglobin, transferrin receptor, ferritin),~     inflammation status (CRP, AGP), gene expression profiles, and potential confounders of child~     cognition such as lengt-for-age, weight-for-length, and weight-for-age Z-scores,~     stimulation/home environment, maternal characteristics will be collected.~      Study outcome: The primary study outcomes will be cognitive score (as Bayley Mental~     Developmental Index or MDI score) and gene expression profiles. Secondary study outcomes will~     be serum PUFA level, iron status (haemoglobin, TfR, ferritin).~      Nature and extent of the burden and risks benefit and group relatedness:~      Subjects, who will be included into the study will invest 14 hours. The consumption of iron~     is not associated with any increased risk of iron overload both for infectious (including~     malaria) and chronic diseases nor consumption of n-3 fatty acids EPA and DHA exceed the US~     Food and Drug Administrator (FDA) Generally Recognized as Save (GRAS) limit. Venous blood of~     5 mL will be drawn at baseline and endline. During screening, children with severe anaemia~     (Hb<70g/L) will be excluded from the study and referred to the local public health center for~     further treatment.~   "
157494|NCT01504620|"~     The goal of this single-center, comparative, open label, in-vitro diagnostic device~     performance evaluation was to investigate the performance of two sanofi-aventis BGMSs~     (BGStar® and iBGStar®) with regard to system accuracy (Polaris), precision and Hct influence~     (Helios).~   "
157495|NCT01504607|"~     Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is~     reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs~     following cataract surgery. However, no data is available regarding endothelial changes after~     cataract surgery with IOL implantation in pediatric eyes.~      The aim of this study is to prospectively observe changes in endothelial cell density,~     coefficient of variation and hexagonality following cataract surgery with IOL implantation in~     pediatric eyes.~   "
157496|NCT01504594|"~     The purpose of this study is to determine whether an autologous stem cell infusion through~     catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy.~      Process:~        1. Primary Evaluation~             -  Clinical History~             -  Echocardiogram to evaluate ejection fraction and other parameters~        2. Signing of Informed Consent and clearing doubts~        3. Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony~          Stimulating Factor) applied subcutaneously~        4. On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by~          hematologists through posterior iliac crests(amount calculated at 8cc/kg, without~          exceeding 150ml).~        5. Recovery room with family members while the cells are being processed in the Hematology~          Laboratory.~        6. Approximately 3 hours after the 1st procedure, the patient re-enters the operation room,~          which is equipped for cardiac catheterization, so that cardiologists infuse the stem~          cells through the femoral artery into the coronary arteries which irrigate the heart´s~          muscle fibers.~        7. Patient goes back to the recovery area until the anesthesia effect is gone and can~          tolerate oral liquids.~        8. Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.~   "
157497|NCT01504581|"~     Study design:~      This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4~     groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of~     HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a~     single dose of a currently marketed PEG-interferon.~   "
157498|NCT01504568|"~     The purpose of the research is to perform a quality assurance evaluation using randomized~     prospective analysis the rate of orbital cellulitis as a complication of nonsurgical orbital~     blowout fracture in patients treated versus not treated with prophylactic antibiotics.~      The investigators goal is to show the use of prophylactic antibiotics in orbital blowout~     fractures does not significantly decrease the rate of orbital cellulitis and is thus not~     indicated.~   "
157499|NCT01504555|"~     Background: The evaluation for hypercortisolism includes an overnight 1mg dexamethasone (DXM)~     suppression test. An important shortcoming is the diagnostic specificity of only 80%, which~     is likely due to inter-individual differences in gut absorption or metabolism of DXM.~      Study hypothesis: The investigators hypothesize that serum-DXM measurements will increase the~     diagnostic accuracy of the overnight DXM-test in the work-up of hypercortisolism.~      Aims: The primary aim of this prospective study is to evaluate if serum-DXM measured~     simultaneously with serum-cortisol in morning samples could increase the diagnostic accuracy~     this diagnostic test. There are several secondary aims. One is to estimate the prevalence and~     causes of unusual DXM absorption or metabolism. The investigators will also evaluate the~     feasibility and diagnostic accuracy of salivary DXM. Moreover, the diagnostic accuracy of~     midnight salivary cortisol and cortisone, and urinary cortisol, will be evaluated and~     compared.~      Design: Levels of DXM in morning serum following an overnight DXM-test will be analyzed in~     patients under evaluation for hypercortisolism (including incidentalomas). A cut-off level to~     identify inadequate DXM concentrations in serum to suppress endogenous cortisol production~     will be established based on the negative tests. This cut-off level will then be applied in a~     retrospective analysis of the diagnostic accuracy of DXM-tests. This prospective study has a~     blinded design as the DXM measurements are disclosed after the end of the trial.~   "
157500|NCT01504542|"~     This study will enroll patients with locally advanced or metastatic non-EGFR mutated~     Non-Small Cell Lung Cancer (NSCLC) lung cancer after failure of at least one but no more than~     two prior approved treatment regimens. Patients will be randomized to receive one of two~     doses of vaccine or placebo to be dosed twice weekly for 18 weeks (36 doses total) and~     patients will also receive erlotinib 150mg taken orally once daily for the duration of the~     trial. The study will examine the immune effects, safety and efficacy of two different doses~     of HS110 vaccine in combination with erlotinib versus erlotinib alone.~   "
157501|NCT01504529|"~     This is an observational, non-interventional and retrospective study in patients with~     advanced PD who have been treated with Rotigotine (Neupro®) as prescribed by physicians~     according to usual clinical practice in Spain.~      The Primary Objective will be to evaluate Non-Motor Symptoms (NMS) in advanced PD patients~     who have been treated with Rotigotine for at least 6 months.~   "
157502|NCT01504516|"~     This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single~     dose, crossover, oral bioequivalence study.~   "
157503|NCT01504503|"~     This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single~     dose, crossover, oral bioequivalence study.~   "
157504|NCT01504490|"~     This study is for patients with advanced solid tumors. The purpose of this study is to test~     the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in~     patients with advanced cancer. CS-7017 and Bexarotene both have many effects on cancer cells,~     including stopping cancer cells from growing and dividing, and causing the cancer cells to~     die. CS-7017 and Bexarotene work on cancer cells in a similar manner and both drugs together~     may have an even greater effect against cancer cells, hopefully, increasing the killing of~     cancer cells.~      CS-7017 is an investigational or experimental anti-cancer agent that has not yet been~     approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene~     is an anti-cancer agent that has been approved by the FDA for patients with a specific type~     of cancer, cutaneous T-cell lymphoma.~      This study will help find out what effects the combination of drugs, CS-7017 and Bexarotene,~     has on cancer. This research is being done because it is not known if CS-7017 is safe to be~     given with Bexarotene.~   "
157505|NCT01504477|"~     Panitumumab plus bortezomib for colon cancer~   "
157506|NCT01504464|"~     Osteoarthritis of the knee is one of the most common causes of disability among elderly. As~     the disease progresses the cartilage become frustrated, surrounding bone react to become~     thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in~     signal density. Patients are treated initially by pain management. In patients who don't~     response to first line treatment invasive treatment like total knee replacement is done. The~     investigators designed this clinical study with the aim of evaluating therapeutic effects of~     intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in patients with~     severe knee osteoarthritis.~   "
157507|NCT01504451|"~     This study is designed to compare three different techniques in ablation of paroxysmal atrial~     fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system,~     the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and~     minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and~     Biosense Webster ablation are non-inferior to Medtronic ablation.~   "
157508|NCT01504438|"~     This is a randomized study to prospectively compare and evaluate the functional outcome and~     patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either~     the STAR or Salto-Talaris prothesis.~   "
157509|NCT01504425|"~     The investigators aim to define the concept of difficult colonic polypectomy and investigate~     whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic~     submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement,~     submucosal injection) and operator experience have an impact on polypectomy outcomes and~     complication rate.~   "
157510|NCT01504412|"~     The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared~     to placebo, in subjects with pain associated with diabetic peripheral neuropathy.~   "
157511|NCT01504399|"~     This is a prospective, multi-center observational study designed to address patient-reported~     nasal outcomes in adults undergoing endoscopic and microscopic surgical removal of pituitary~     tumors. The primary objective of this study is to determine the difference in nasal outcomes~     by using the Anterior Skull Base (ASK) Nasal survey between patients treated with endoscopic~     surgical technique and those treated with microscopic surgical technique. Patients will be~     given the ASK Nasal survey to assess their nasal functioning and overall health before their~     surgery, and at post-operative visits 1-2 weeks, 3 months, and 6 months.~   "
157512|NCT01504386|"~     The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane~     (TAP) block as a part of a multimodal postoperative pain management after robot-assisted~     laparoscopic hysterecomy.~   "
157513|NCT01504373|"~     Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical~     ventilation. This mode of ventilation is currently in routine use in adult, pediatric and~     neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle~     used during inspiration, is measured. The ventilator triggers (synchronizes patient effort)~     and applies proportional assistance based on measured electrical activity of the diaphragm~     (Edi). This electrical activity is measured through a feeding tube that also has a~     multiple-array esophageal electrode in it. This mode of ventilation has been proven to be~     equivalent to pressure support ventilation (PSV). Theoretically, the breath-to-breath control~     offered by NAVA may not only trigger faster and synchronize better, but provide the support~     deemed appropriate by the central nervous center on demand. Traditionally in the intensive~     care unit (ICU), pressure support is applied to subject breathing spontaneously. Pressure is~     set to achieve a given tidal volume. The influence of changing lung compliance not only from~     the lung disease itself, but the interactions of the respiratory muscles can drastically~     change minute ventilation and contribute to hyper- or hypoventilation. These changes are~     typically found on assessment of end-tidal carbon dioxide (CO2), blood gas, or oxygen~     saturation (SpO2) monitoring; all of which are potentially preventable if we allowed the~     central nervous system to control the ventilator. NAVA may allow us to couple the central~     nervous system (neuro-coupling) with the ventilator to provide real-time proportional~     assistance, reduce work of breathing and apply physiologic breathing patterns.~   "
157523|NCT01504230|"~     Osteoporosis is a prevalent health concern among older adults and is associated with an~     increased risk of falls that can cause fracture, injury and even mortality. Identifying the~     factors related to falls occur within this population is essential for the development of~     effective regimes for fall prevention. The long-term objectives of this work are to ascertain~     the mechanisms for effectively controlling balance in seniors with osteoporosis and to~     provide a basis for developing fall prevention programs. The entire body's center of mass~     (CoM) is a critical indicator for balance control and the coordination among joints and~     muscles to control the CoM is still unclear. The aim1 of this study is to develop~     biomechanical models that control the entire body's center of mass (CoM) during upright quiet~     stance in seniors with osteoporosis. The aim2 of this study is to identify the mechanism to~     control the entire body's CoM after receiving a balance perturbation in seniors with~     osteoporosis. The findings of this research can provide needed information regarding the~     processes of balance control in this vulnerable osteoporosis population, and has the~     potential to be applied to individuals with other neuromuscular and orthopedic deficits.~   "
177866|NCT01236911|"~     Will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in~     hospital)after moderate - severe TBI that the patients that do not developed this condition?~   "
157514|NCT01504360|"~     Development of sarcoma within or adjacent to radiation field is a well known event of poor~     prognosis and unknown risk factors. Advanced techniques of radiation therapy including~     intensity modulated radiation therapy, tomotherapy or Arc therapy are providing new~     modalities of radiation delivery that could be responsible for developing these induced~     tumors. There is little data on molecular biology of radiation induced sarcoma even if some~     tools are still available to characterize these types of tumors aiming to compare their~     profile to a sarcoma observed in non irradiated area. An update of the GETO-GCSF registry,~     currently called CONTICANET data base in the framework of EORTC, represents the backbone of~     the project. The next step should follow two axes, a clinical one based on the dosimetric~     analysis of the characteristics of delivered radiation therapy and the second one based on a~     molecular characterization of the sarcomas developed in irradiated field.The data base will~     be updated and organized through the CONTICANET network and the radiation oncologists~     involved in the treatment of soft tissue sarcoma. A retrospective analysis of the clinical~     data and the parameters describing the initial treatment will be registered using the~     methodology proposed by I. Diallo for radiation induced tumors developed in childhood. The~     most recent data will be extracted in DICOM format for intercomparison in a dedicated~     software.A centralized review of pathological specimens is planned to validate the correct~     classification of the tumors inside the current staging system developed for soft tissue~     sarcoma.~   "
157515|NCT01504347|"~     Section 1:~      The purpose of the study is to obtain safety and immunogenicity data of different dose levels~     of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without~     adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the~     basis for dose/formulation selection for Section 2 of the study.~      Section 2:~      An additional purpose of the study is to evaluate the safety and immunogenicity of the~     optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative~     and seropositive healthy subjects aged 18 to 70 years.~   "
157516|NCT01504334|"~     Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive form of lung disease~     characterized by fibrosis of the supporting framework (interstitium) of the lungs. By~     definition, the term is used only when the cause of the pulmonary fibrosis is unknown~     (idiopathic). Microscopically, lung tissue from patients shows a characteristic set of~     histologic/pathologic features known as usual interstitial pneumonia (UIP). UIP is therefore~     the pathologic counterpart of IPF.Idiopathic pulmonary fibrosis is characterized by~     radiographically evident interstitial infiltrates predominantly affecting the lung bases and~     by progressive dyspnea and worsening of pulmonary function. No therapy has been clearly shown~     to prolong survival. The current strict definition of idiopathic pulmonary fibrosis provides~     a new focus for basic and clinical research that will improve insight into the pathogenesis~     of this disorder and stimulate the development of novel therapies.~      Pirfenidone has proven antifibrotic and anti-inflammatory properties in various in vitro~     systems and animal models of pulmonary fibrosis, although its precise mechanism of action~     remains unclear. It attenuates fibroblast proliferation, production of fibrosis-associated~     proteins and cytokines, and the increased biosynthesis and accumulation of extracellular~     matrix in response to cytokines such as transforming growth factor-β. It is also shown to~     slow tumor cell proliferation by inhibiting fibroblast growth factor, epidermal growth factor~     and platelet-derived growth factor.~      Pirfenidone has not been widely approved for clinical use in China, in this study, safety and~     efficacy were evaluated to see if pirfenidone has a significant advantage over placebo in~     terms of improving lung function and life quality etc. (see primary and secondary criteria)~     or slows down the deterioration of lung function in Chinese subjects diagnosed with IPF.~   "
157517|NCT01504321|"~     Polycystic ovary syndrome affects a striking 9-18% of Australian reproductive aged women and~     has been associated with a number of metabolic abnormalities.~      Given the strong correlation between metabolic abnormalities and increased sympathetic~     activity, we hypothesise that reducing this activity using medication (moxonidine) can help~     improve the metabolic abnormalities, and therefore improve outcomes in polycystic ovary~     syndrome.~   "
157518|NCT01504308|"~     The purpose of this clinical study is to determine whether treatment with the Philips~     Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is~     effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).~   "
157519|NCT01504295|"~     It is proposed to test metadoxine (MTDX) that it is hypothesized to be significantly~     beneficial for the treatment of alcoholism and ALD. Metadoxine is currently approved in~     Europe for acute and chronic alcohol intoxication but has never been tested in the US.~     Furthermore, MTDX is used in Europe to treat ALD. Preliminary evidence shows that MTDX~     reduces alcohol consumption in AD individuals. If the role of MTDX in reducing alcohol~     consumption and improve liver function is confirmed by a rigorous study design, then MTDX~     might represent a truly innovative pharmacotherapy for AD, given the potential to be used for~     AD individuals with ALD. However until this proposal, MTDX has never been investigated as a~     treatment for AD able to reduce both alcohol consumption and improve alcohol-related liver~     damage via a double-blind placebo-controlled study. This project therefore proposes to~     conduct a 12-week (followed by a 3-month follow-up), double-blind, placebo-controlled,~     between-subject randomized clinical trial with MTDX (500mg t.i.d.) in AD individuals.~   "
157520|NCT01504282|"~     To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during~     photorefractive keratectomy (PRK) for patients with low myopia.~   "
157521|NCT01504256|"~     The purpose of this study is to determine the efficacy of catumaxomab by determination of the~     rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one~     cycle (four doses) of catumaxomab followed by six cycles of routine neoadjuvant chemotherapy.~   "
157522|NCT01504243|"~     CD163 is a member of the scavenger receptor cysteine-rich family (SRCR) is exclusively~     expressed on cells of the monocyte lineage.CD163 acts to amplify inflammation and serves as a~     critical mediator of inflammatory response in the context of sepsis. This study was designed~     to investigate whether CD163 genomic variations were associated with the prognosis of sepsis.~     We sequenced 30 sepsis patients with CD163 gene of seventeen exons by PCR sequencing. When~     analyzing the results of sequencing, we found five gene polymorphisms located in~     exon-2,exon-5 and exon-11, respectively. Compare with the NCBI dbSNP and Hapmap database, one~     polymorphisms located in exon-2 is non-synonymous variation rs3210140, two polymorphisms~     located in exon-5 are synonymous variations rs4883264 and rs4883263, the last two located in~     exon-11 are synonymous variations rs61729512 and rs150018775 . Five common polymorphisms~     (rs2234237,rs2234246) within the CD163 gene were detected in 200 patients with severe sepsis~     and in 200 healthy control subjects. This study was explored that whether or not~     polymorphisms detected within the CD163 gene may play a major role in the predisposition to~     prognosis of sepsis in a Chinese Han cohort.~   "
157524|NCT01504217|"~     Falling among older adults is a major public health concern. In fact, falls are the leading~     cause of accidental death in older adults both in Taiwan and in the United States. In order~     to provide effective preventative strategies, the investigators must understand the~     mechanisms that cause older adults to fall. Thus, the investigators research aim for three~     objectives: (1) using biomechanical model to identify the deficits in neuromuscular control~     for older adults (2) to apply research findings to the development of new clinical methods~     for assessing and recovering balance control in older adults, and (3) to predict fall risks~     in 1-2 year for older adults from the research findings.~   "
157525|NCT01504204|"~     The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel~     in patients with mild to moderate acne who receive a medication sample and instructions on~     proper application with their stock size medication tube versus patients who receive only the~     stock size medication tube.~   "
157526|NCT01504191|"~     The overall aim and primary objective is to evaluate the effects on level of depression and~     anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a~     myocardial infarction (MI).~   "
157527|NCT01504178|"~     Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations~     that could be, in part, due to a central modification of nociception mechanisms. Previous~     studies have shown that pain perception was altered in Parkinson's disease (subjective and~     objective pain thresholds and pain-induced cerebral activity) and that administration of~     L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in~     dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain~     threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be~     involved in pain alteration in PD.~      To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine~     (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that~     duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients~     with PD.~      36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine~     increase the pain perception level compare to the placebo. This increase would be the same~     than those observed with L-Dopa.~   "
157528|NCT01504165|"~     This is an open-label, non-randomized, parallel-group, mono-center, single intravenous dose,~     Phase I trial to investigate the Pharmacokinetic (PK) and safety of cilengitide in subjects~     with different grades of renal impairment as compared to subjects with normal renal function.~   "
157529|NCT01504152|"~     The purpose of this study is to survey patients who underwent hematopoietic stem cell~     transplant (HSCT) to assess if they have traveled or not internationally after transplant.~     This information will help to improve the understanding of the needs for travel health~     strategies and interventions to provide healthy and safe travel to HSCT patients. The~     findings of this survey will also be used to develop travel health related interventions for~     patients living with cancer as well.~   "
157530|NCT01504139|"~     The purpose of this study is to investigate levels of progesterone in the luteal phase after~     various stimulations in the follicular phase and treatment with GnRH antagonist protocol~     followed by GnRHagonist as induction of ovulation.~   "
157531|NCT01504126|"~     The goal of this clinical research study is to learn if it is feasible to give a beta-blocker~     such as Inderal (propranolol hydrochloride) with standard chemotherapy (paclitaxel and~     carboplatin or possibly docetaxel) to treat ovarian cancer. The safety of propranolol~     hydrochloride will also be studied.~      Propranolol hydrochloride is designed to block certain chemicals that affect the heart.~     Researchers want to learn if this might also boost the immune system, allowing the~     chemotherapy to be more effective.~      Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.~      Carboplatin is designed to interfere with the growth of cancer cells by stopping cell~     division, which may cause the cells to die.~   "
157532|NCT01504113|"~     Background:~      Psoriasis is a chronic, immunologically-mediated, inflammatory skin disease and targeted~     therapies e.g. tumor necrosis factor (TNF)-α and TH-17 antagonists have become increasing~     important agents in the management of psoriasis. TNF, interleukin-17 (IL-17) and TH-17 play~     major roles in defense against infection. Large-scaled clinical trials and post-marking~     surveillance had shown these agents may increase susceptibility to infections. Most studies~     evaluate the reactivation of tuberculosis but the influence of targeted therapies on the~     viral infection has not been extensively investigated.~      TNF-α has been shown to contribute to the killing of cytomegalovirus (CMV)- and human~     papillomaviruses (HPV)-infected cells. Additionally, recent studies have shown a high~     prevalence of HPV DNA in psoriatic skin and increased HPV5 antibodies in patients with~     psoriasis. The prevalence of HPV in the skin was also affected by therapeutic modalities,~     such as psoralen-ultraviolet A (PUVA). Several case reports in which CMV, Epstein-Barr virus~     (EBV) and HPV infection complicated therapy with TNF-α antagonists have been reported.~     However, the study investigated the effect of TNF-α antagonists and other biologics on~     reactivation of latent viruses is limited. Only two studies investigated the short-term~     effect of infliximab on reaction of herpesviruses in patients of rheumatoid arthritis and~     Crohn's disease. The high prevalence of combination use of immunosuppressants, such as~     methotrexate alongside with TNF-α antagonists in these patients is different from patients~     with psoriasis. Additionally, various bacterium and fungi, such as Staphylococcus aureus,~     Malassezia are associated with provocation and/or exacerbation of psoriasis and recent~     studies had shown IL-17 is essential for the immune response to common fungus Candida~     albicans.~      Aim:~      The aim of this study is to prospectively investigate the effect of target therapies (TNF-α,~     TH-17 antagonist, IL-17 antagonists, tofacitinib and apremilast) on the activation of~     viruses, including CMV, EBV and HPV and the impact of biologics on the prevalence of surface~     colonization of microorganism, including HPV, bacteria and fungi, in patients with psoriasis.~      Methods and procedures:~      Our project consists of two related study. The first (Study 1), a prospective observational~     study, included patients with psoriasis who are going to undergo biologics therapy, the viral~     loads of CMV and EBV, HPV DNA detection in eyebrow hairs and skin scales, and bacterial,~     fungal cultures from skin scales were performed before the initiation, 12 and 24 weeks after~     initiation of the target therapies, 12 weeks after discontinuation of target therapies. This~     part of our project is to investigate the dynamic effect of biologics on the microorganisms~     in patients with psoriasis. The second part (Study 2), a case control study, recruits~     psoriasis patients who have started target therapies, they receive the sampling of blood,~     eyebrow hairs and skin scales for CMV, EBV and HPV investigations when they are enrolled.~     Control group compromised of age-and disease severity-matched psoriasis patients who are not~     treating with target therapies or other systemic antipsoriatic agents. Comparison of the~     prevalence of latent virus, virus reactivation, bacteria and fungi skin colonization between~     psoriasis patients who are treating with and without target therapies is performed. The aim~     of study 2 was to assess any difference of the status of latent virus or microorganism~     colonization in skins between psoriasis patients treated with and without target therapies.~   "
157533|NCT01504100|"~     Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The~     efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been~     reported good outcomes in most patients. However, some studies reported less effective in~     patients with higher body mass index, larger lateral patellofemoral angle, and smaller Q~     angle. The investigators hypothesized that femoral internal rotation is a negative factor to~     the patellar taping. The investigators enroll consecutive 100 patients with anterior knee~     pain and radiographic evidence of patellar subluxation. The investigators determine femoral~     rotation via physical examination. The visual analogue scale was evaluate to compare the~     result between the those with and without femoral internal rotation.~   "
157534|NCT01504087|"~     Venous thromboembolism (VTE) is one of the major public health problems in Western country.~     More than 100,000 Americans die each year from VTE. VTE is also a common complication of~     critical illness,1-2 and probably related to poor outcome in this patient group. Although~     there are guidelines about VTE prophylaxis in acutely ill medical patients and patients in~     medical ICU3, they are overlooked in our daily practice frequently in our country. There are~     many reasons for our common practice, including inadequate knowledge for the ICU physicians,~     more patients with bleeding tendency in ICU and low prevalence of VTE in our (eastern)~     country. However, the true prevalence of VTE in ICU and if thromboprophylaxis still needed in~     certain high risk patients are not unknown. Besides, if there is a difference in the VTE rate~     between western and eastern patients, what is the underlying mechanism? The major objective~     of this application is to answer the first part of the problem, i.e. to delineate the scope~     of this problem.~      The specific aims of this application are as follows:~        -  prevalence of venous thromboembolism in ICU in Taiwan~        -  specific risk in subgroups of ICU patients~        -  prevalence and risk factors for silent pulmonary embolism~   "
157535|NCT01504074|"~     Purpose: To evaluate morphological and functional characteristics of Irvine Gass syndrome~      Methods: 30 patients suffering on Cystoid macular edema (CME) secondary to Cataract surgery~     will be observed and evaluated by fluorescein-angiography, SD-OCT, reading performance,~     contrast sensitivity and microperimetry in a fixed time schedule~   "
157536|NCT01504061|"~     This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of~     Mederma N&I to Mederma Ultra Gel on the appearance of post-surgical scars.~   "
157537|NCT01504048|"~     The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye~     spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due~     to chronic watery diarrhea.~   "
157538|NCT01504035|"~     The goal of this study was to test the efficacy of local analgesic (lidocaine) loaded~     hemostatic putty in reducing donor site pain following the harvest of pelvic bone grafts. In~     14 patients undergoing harvest of a pelvic bone graft during foot surgery, the bone defect at~     the pelvis was either filled with a lidocaine loaded hemostatic putty (Orthostat-L) or the~     same putty without lidocaine (Orthostat, currently marketed as Hemabsorb). Postoperatively,~     foot pain was eliminated with a peripheral nerve block, while pelvis pain was quantified with~     two commonly used pain rating scales (VAS and Wong Baker). Blood samples were collected at~     regular time intervals to measure lidocaine levels. Patients which received the lidocaine~     loaded putty experienced significantly less pain during the first 12 hours after surgery as~     compared to those patients who received the lidocaine deficient putty. Blood lidocaine levels~     always stayed below the toxic threshold.~   "
157539|NCT01504022|"~     The WISH-trial is an open-label, parallel-group, randomized controlled trial. The effects of~     self-measuring of the blood pressure at home and the use of a pro-active web-based feedback~     system on the blood pressure, number of antihypertensive drugs used, and surrogate~     cardiovascular markers during a 12 month period will be investigated.~   "
157540|NCT01504009|"~     Patients with neuropathic diseases are experiencing increasing muscle weakness, loss of~     muscle strength and functional abilities during their illness. In healthy people, regular~     exercise is the best way to maintain or improve muscle strength, endurance and general health~     status and thereby maintain functioning abilities. Previously, patients with neuromuscular~     diseases were advised to avoid any kind of physical exercise. However, lately a number of~     studies have evaluated the effect of training in patients with neuromuscular diseases, and~     positive effects on the functional abilities have been found. Based on these findings we want~     to investigate the mechanisms leading to development of muscle atrophy and loss of functional~     abilities, and to explore the opportunities of reducing muscle wasting and thereby improve~     the course of the disease development through strength training.~      The main objective is to investigate the effects of strength training on slowing disease~     progression and reduce the decline in muscle strength and function in patients with~     amyotrophic lateral sclerosis (ALS). In addition, the aim is to carry out detailed studies of~     biological processes in muscle tissue in order to unveil mechanisms leading to muscle~     atrophy, and to examine effects of a strength training program. The goal is to be able to~     incorporate strength training in the treatment program of these patients in order to maintain~     muscle strength and function in the individual for as long as possible.~      Minimum 10 patients with the disease are included in the study. Through a 12 week period the~     patients will participate in strength training 2-3 times per week. Muscles biopsies will be~     taken (i) 12 weeks before commencement of strength training program, (ii) at the beginning of~     training and (iii) after 12 weeks of strength training. Patients will function as their own~     controls. Blood samples will be collected simultaneously in order to follow the development~     of the strength training. Furthermore, participants will be assessed through at number of~     functional tests and questionnaires evaluating their strength, balance and social/~     psychological status.~      Subjects are recruited through their association with Odense University Hospital. In the~     present study, the participants become part of a social network, while participating in~     organized training sessions, and thus have a possibility to make contact with other ALS~     patients in the same situation as themselves.~   "
157541|NCT01503996|"~     The purpose of this study is to examine if a chronic dehydration is a risk factor for the~     developement or progression of some forms of glaucoma.~   "
157542|NCT01503983|"~     The objective of the study is assess the efficacy and safety of Trastuzumab in combination~     with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or metastatic~     gastric cancer or gastro-esophageal junction, (HER2)-positive.~   "
157543|NCT01503970|"~     The purpose of this study is to assess safety and efficacy of autologous chondrocyte~     implantation delivered arthroscopically into chondral lesions of the knee using clinical,~     biochemical, and MRI outcomes.~   "
157544|NCT01503957|"~     The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of~     persistent allergic rhinitis when applied before allergen challenge.~   "
157545|NCT01503944|"~     The purpose of this study is to evaluate the ability to identify individuals with~     dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia~     with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from~     Alzheimer's disease (AD) and control subjects.~   "
157546|NCT01503931|"~     The mesolimbic dopaminergic reward system is a key structure underlying addictive behaviour~     in alcohol addiction and is under control of prefrontal glutamatergic neurotransmission. The~     aim of the present multicenter-study in Berlin, Bonn and Mannheim is to use functional~     magnetic resonance imaging (fMRI) in alcohol addiction for endophenotyping in order to study~     the relevance of genetic variation, in particular in dopaminergic and glutamatergic genes,~     for addiction. The investigators will use a temporal discounting and a cue reactivity~     paradigm in alcoholics and healthy controls in order to 1) test the impact of genetic~     variation on activation of the mesolimbic system in these populations and to 2) to test their~     predictive effects for treatment outcome in alcoholics. The subproject will thus bridge~     animal research on genetically determined cue reactivity and human studies in alcoholics.~     Furthermore, the investigators will link these results to the measurement of glutamate and~     glutamine with magnetic resonance spectroscopy (MRS) in subproject SP14.~   "
157547|NCT01503918|"~     The purpose of this study is to determine whether reactivation of latent cytomegalovirus~     infection in critically ill patients looked after in the intensive care unit can be~     successfully and safely prevented using antiviral agents. Comparison is made between standard~     care, and treatment with one of two different antiviral regimens: valaciclovir/aciclovir,~     which has a favourable side effect profile but requires high dosage to be effective, and~     valganciclovir/ganciclovir, which has more side effects, but has been demonstrated to be~     effective in low dosage.~      The primary hypothesis is that cytomegalovirus reactivation can be effectively suppressed~     with antiviral prophylaxis.~   "
157548|NCT01503905|"~     The current study is a multicentre, randomized, open (unblended), prospective clinical trial~     which is sponsored by the researchers. The trial is designed to compare the effectiveness~     between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as~     neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to~     compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant~     chemotherapies. The investigators will randomly assign 600 premenopausal female patients with~     operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four~     cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of~     neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy.~     Patients will undergo modified radical mastectomy or breast-conserving surgery after four~     cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles),~     radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011)~     guideline. The follow-up will be ten years after surgeries. The primary aim is to examine~     whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin,~     and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival~     (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced~     amenorrhea with outcomes in premenopausal women.~   "
157549|NCT01503892|"~     This study focuses on the use of Metanx® as the sole treatment for improving and reversing~     nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal~     study groups enrolled in this randomized double blinded study. The minimum sample size of~     enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum~     number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or~     patients who have been diagnosed with diabetes type II for less than five years are included~     in this study. The control group will receive placebo pill twice daily versus the treatment~     group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal~     nerve fiber densities obtained by skin biopsies taken at the beginning of the study before~     any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of~     twelve months to re-biopsy. In addition each group will answer three sets of questionnaires~     relating to their peripheral neuropathy at initial, three months, twelve month visitations.~     If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies~     will show an increase in intraepidermal nerve fiber density and an improvement in the~     subjective score versus the placebo group.~   "
157550|NCT01503879|"~     Mechanical ventilation is a therapeutic method used in order to keep gas exchange adequate to~     cell metabolism in patients with acute respiratory failure. It is currently proved that,~     although on one hand the use of this method keeps gas exchange, on the other hand it promotes~     and supports pulmonary inflammatory processes (VILI). A recent study about the effect of~     positive end-expiratory pressure (PEEP) on DLCO (diffusing capacity of the lung for carbon~     monoxide) in patients undergoing invasive mechanical ventilation has proved that patients~     without any evident pulmonary disease (negative medical history, negative chest clinical~     examination, normal chest X-ray radiography and normal arterial oxygen tension [PaO2]) after~     24 hours of invasive mechanical ventilation show a significant worsening of pulmonary gas~     exchange properties. The authors have supposed that this worsening may be caused by an early~     alteration of alveolar-capillary membrane caused by mechanical ventilation itself. This~     hypothesis finds support in some studies carried out on animal models which founds that~     mechanical ventilation, even when low tidal volumes (Vt) are set for a few hours, is able to~     induce lung injury (as shown by histologic findings). The most sensitive and specific tools~     the investigators can currently rely on for the study of alveolar-capillary membrane are the~     measurement of diffusing capacity of the lung for carbon monoxide (DLCO) and the evaluation~     of plasmatic levels of pulmonary surfactant protein B (SPB). DLCO is a standard, widely~     diffused technique for the evaluation of functional alterations of alveolar-capillary~     membrane and it is currently available also for patients undergoing invasive mechanical~     ventilation. SBP is produced by type II pneumocytes in the alveoli. An increase of its~     plasmatic levels is correlated to a decay of pulmonary gas exchange; SPB thus can be~     considered an alveolar-capillary membrane anatomical damage marker.~      The primary end-point of this study is to evaluate the changes of anatomical (SPB) and~     functional (DLCO) features of alveolar-capillary membrane between the spontaneous breathing~     and mechanical ventilation as well as the progressive changes affecting DLCO and SPB over~     time during general anaesthesia and mechanical ventilation in patients with otherwise healthy~     lung undergoing elective surgery. This in order to check the timing of the observed worsening~     of alveolar-capillary membrane function, and to find out if the process is progressive in~     time.~      The secondary end point is to check if the alterations of functional features of alveolar~     membrane (DLCO) are proportionate to the increase of alveolar injury marker (SPB), in order~     to understand if the worsening of alveolar-capillary membrane function is to be attributable~     to an anatomical damage or to a physiologic change of the ventilation-perfusion matching.~   "
157551|NCT01503866|"~     The purpose of this study is to determine the absorption and excretion kinetics of~     bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and~     feces in men following a single oral does or 20 mg of [14C]-bardoxolone methyl.~   "
157552|NCT01503853|"~     Background:~      - The costs of medical care have a major effect on patients during illness and treatment.~     Surveys with patients and doctors show that both are interested in discussing the costs of~     treatment. But they rarely talk about these issues. Both worry about whether it is~     appropriate to discuss financial matters in the clinical setting. They are also concerned~     about whether this topic will be an awkward one. Researchers are interested in studying how~     people want their doctors to talk to them about the costs of illness and medical care.~      Objectives:~      - To explore and better understand patients views on whether and how doctors should talk~     about the costs of illness and medical care.~      Eligibility:~      - English- or Spanish-speaking adults (at least 18 years of age) who are covered by health~     insurance.~      Design:~        -  Participants will be asked to take part in a 2 1/2-hour focus group. Ten to 12 people~          will come together to discuss their thoughts and opinions.~        -  A member of the research team will lead the group discussion. The leader will ask a list~          of questions about health care payment issues. Those in the focus group will discuss~          these issues.~        -  Participants will receive a small cash payment and a light snack.~   "
157553|NCT01503840|"~     Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate~     residual postoperative paralysis but it represents the most simple, inexpensive and~     widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered~     the gold-standard to avoid PORC (post operative residual curarization).~      This clinical trial is conducted to verify the reliability of accelerometer-based~     neuromuscular monitoring in order to exclude postoperative residual paralysis which is not~     highlighted by this instrument at a TOF-ratio=100%.~      The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests~     after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100%~     allows to evaluate whether the recovery of muscle function is concrete, although the~     monitoring device shows a complete decurarization; patients treated with sugammadex should~     not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.~   "
157554|NCT01503827|"~     People with brain metastases from melanoma are offered different treatment options after~     local treatment of their brain metastases via surgery or stereotactic irradiation. Depending~     on the treating institution and the clinician involved a patient may or may not be offered~     whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with~     stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain~     metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT~     on quality of life and brain functions such as memory, speech and concentration. Participants~     will be randomised after local treatment of their brain metastases to either WBRT or~     observation. 220 people will be recruited from sites in Australia, Norway, the UK, the US and~     other international sites.~   "
157555|NCT01503814|"~     The goal of this study is to develop, pilot test, and evaluate a highly simplified but~     guideline-based program for cardiovascular management for application in resource-scarce~     settings. The study aims to assess the effects of implementing a simple low-cost~     cardiovascular management program for high-risk individuals, delivered by primary care~     providers (PCPs) or community health workers (CHWs), on the proportion of patients~     appropriately treated with diuretics as well as a number of secondary outcomes in~     resource-scarce Tibet, China and Haryana India.~   "
158765|NCT01487954|"~     This phase II trial is studying how well alkaline water works in reducing skin toxicity in~     women with breast cancer undergoing radiation therapy. Alkaline water may reduce radiation~     therapy-related skin toxicity in patients with breast cancer.~   "
157556|NCT01503801|"~     Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence~     will:~        1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death~        2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay~          without increasing adverse effect~   "
157557|NCT01503788|"~     Dural or lumbar puncture (LP), the passing of a needle into the space of the spinal cord, is~     a common procedure in everyday clinical practice. The most common use for LP is to measure~     the spinal fluid pressure and sample spinal fluid for laboratory analysis. However, it is~     also used for therapeutic purposes, such as administering chemotherapy or spinal anesthesia.~      A notorious side effect of dural puncture is headache that ranges from mild to debilitating~     and may last for several days following the procedure. Among diagnosed patients, 39%~     experience at least 1 week of impaired ability to perform activities of daily living. The~     likelihood of developing a headache after dural puncture depends on a number of factors. As~     fluid leak is assumed to be the culprit mechanism in this headache strategies to minimize the~     leak seem to offer the best path to lowering the incidence of headache after diagnostic LP,~     the commonest clinical context of dural puncture in medical practice.~      Lumbar puncture is a highly stressful event for most patients. As both pain and anxiety cause~     adrenergic stimulation, they also cause an increase in ICP. We believe that this mild~     increase in ICP, occurring before the puncture as well as during the puncture itself may~     exacerbate the pressure difference between the CSF space and the epidural space and so worsen~     the CSF leak Furthermore, this excess pressure, although mild, might cause the dural puncture~     hole to widen slightly and so further augment the leak and possibly even prolong it.~     Furthermore, the very anticipation of pain causes a rise in neurotransmitters that may cause~     a sensitization effect and worsen pain. This increase in adrenergic drive as well as the~     sensitization to pain can be effectively blunted by the periprocedural use of mild IV~     sedation. Benzodiazepines, with their sedative-hypnotic qualities are well suited for this~     task.~      This study aims to test the effect of mild peri-procedural IV sedation using Midazolam on the~     rates of headache after diagnostic LP.~      Patients undergoing a diagnostic LP will be randomized into two groups. Group 1 will undergo~     the procedure as routinely practiced. Group 2 will be given Midazolam IV 10-5 minutes prior~     to the procedure and undergo the same diagnostic procedure. All patients in the study will~     remain under observation in the hospital for at least 6 hours.~      Patients will be evaluated for headache and specifically for headache. Clinical follow up~     will continue for 72 hours by administering a short questionnaire over the telephone.~   "
157558|NCT01503775|"~     The objective of this study is to evaluate the long term efficacy and safety of the CODMAN~     TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or~     non-ruptured aneurysms in real-life routine clinical practice.~   "
157559|NCT01503762|"~     Objective: The purpose of this study is to determine effects of mirror therapy in restoring~     hand function in patients with flexor lag following orthopedic injuries.~      Methods: In a prospective randomized controlled trial, 22 patients with Flexor Lag will be~     measured. Intervention group will receive mirror therapy, 30-minute a day, 5 days a week for~     3-week, as well, half an hour conventional rehabilitation after each mirror therapy session.~     Patients in the control group will receive the same treatment program, but instead of mirror,~     they will directly observe the affected hand. Outcome measures including Total Active Motion~     (TAM), and Disabilities of Arm, Shoulder and Hand (DASH) questionnaire will be administered~     before and after the treatment period and 3 weeks after the final treatment session.~   "
157560|NCT01503749|"~     The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for~     the treatment of patients with advanced liver cirrhosis.~   "
157561|NCT01503736|"~     The purpose of the study is to determine the effect and optimum dose and evaluate the safety~     of ferric citrate, administered three times daily (TID) immediately after meals for a total~     daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end~     stage renal disease (ESRD).~   "
157562|NCT01503723|"~     Metabolomics, or metabonomics, is a large-scale approach to monitoring as many as possible of~     the compounds involved in cellular processes in a single assay to derive metabolic profiles.~     Metabolomics allows for a global assessment of a cellular state within the context of the~     immediate environment, taking into account genetic regulation, altered kinetic activity of~     enzymes, and changes in metabolic reactions. Metabolomics may be useful for understanding~     metabolic imbalances and for diagnosis of human disease. The investigators plan to collect~     exhaled breath condensate from patients with acute lung injury. Metabolomic analysis in the~     patients may help us to explore some novel biomarkers for the disease diagnosis and outcome~     prediction.~   "
157563|NCT01503710|"~     The purpose of this study is to determine soluble HJV could be an early diagnosis urinary~     biomarker of ischemia/reperfusion injury in post CPB-patients.~   "
157564|NCT01503697|"~     Technetium-99m NC100692 Injection is under development as a diagnostic radiopharmaceutical~     for targeting angiogenesis associated with diseases such as primary and metastatic cancer,~     and for targeting active fibrosis in cardiac diseases such as developing heart failure and~     developing hypertrophic cardiomyopathy.~      A principle goal of imaging is identification of disease processes early in their~     development, at times prior to symptoms. In cancer, angiogenesis is essential for a tumour to~     exceed approximately 1-2 mm3 in size.As markers of angiogenesis are often expressed early in~     the growth of a tumour it is postulated that imaging of angiogenesis can assist in early~     diagnosis of cancer, relapse or spread, and monitoring response to therapy.~      Technetium-99m NC100692 Injection will be tested on 3 populations of pts:~      1.30 patients at high risk For breast cancer 2.30 patients with breast cancer 3.15 patients~     with locally advanced breast cancer undergoing treatment.~   "
157565|NCT01503684|"~     In this proposal, the investigators wish to investigate, identify and validate potential~     biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis.~   "
157566|NCT01503671|"~     Background~      Heart failure is the final consequence of various heart disease and is also the leading cause~     of mortality worldwide. Diastolic dysfunction refers to an abnormality of diastolic~     distensibility, filling, or relaxation of the left ventricle. Patients with hypertensive left~     ventricular hypertrophy and an echocardiogram showing a normal ejection fraction and abnormal~     left ventricular filling can be said to have diastolic dysfunction. If pulmonary edema or~     effort dyspnea developed in such a patient. The term diastolic heart failure would be~     appropriate.~      Pathology leading to diastolic heart failure include: impaired relaxation, increased passive~     stiffness, endocardial and pericardial disorders, microvascular flow and neurohormonal~     regulation. Among them, the association of pro-inflammatory system and diastolic dysfunction~     are already established. The investigators therefore hypothesized that the change of serum~     inflammatory markers might be associated with the change of left ventricular diastolic~     function and the investigators thus conducted a randomized case-control trial with this~     regard.~      Method and materials~      This is a case-control randomized study. The definition of left ventricular diastolic~     function is according to Guideline from the ACC and AHA. The investigators will evaluate left~     ventricular diastolic function noninvasively by echocardiography before and after the~     intervention. Exclusion criteria include coronary artery disease, significant valvular heart~     disease, cardiomyopathy, pericardial disease and renal insufficiency. The investigators would~     like to enroll 50 cases and the same numbers of the controls. The inclusion criteria are~     subjects who underwent peritoneal dialysis at the investigators hospital for more than 6~     months with higher pro-inflammation serum cytokine levels (C-reactive protein > 0.2mg/dL).~     Atorvastatin (40mg/day) would be given to those who were allocated to the intervention group.~     The investigators will than follow up cardiac diastolic function by echocardiography and also~     the change of serum markers. The investigators would also genotype the~     inflammation-associated genes and their promoter region and find the association between~     genetic polymorphisms and the treatment effects of statins.~   "
158766|NCT01487941|"~     The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead~     Setrox JS.~   "
157567|NCT01503658|"~     This study has an open-label, five-period, single-sequence design. The purpose of this study~     is as follows;~        1. Primary~             -  To evaluate the influence of genotype of drug metabolizing enzyme or transporter on~               the pharmacokinetics/pharmacodynamics of clopidogrel~             -  To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of~               clopidogrel~        2. Secondary~             -  To explore the representative biomarkers for the variable~               pharmacokinetics/pharmacodynamics of clopidogrel~             -  To evaluate the influence of genotype of drug metabolizing enzyme or transporter on~               the drug-drug interactions between aspirin and clopidogrel~             -  To explore the representative biomarkers for the drug-drug interactions between~               aspirin and clopidogrel~   "
157568|NCT01503645|"~     1. Chinese herb nephropathy (CHN), a kind of kidney failure caused by Chinese herbs, may be~          related to the a component called aristolochic acid (AA).~        2. AA may form AA-DNA adducts and accumulate in the kidney and ureter and cause kidney~          failure and/or cancer~        3. Different enzymes have been reported to detoxify plant alkaloids or other components.~          Genes that regulate the production of these metabolic enzymes may affect the chance of~          CHN.~        4. By comparing the differences in the polymorphisms of these genes between patient with~          CHN and control, we may find the changes that play a significant genetic factors for~          CHN.~   "
157569|NCT01503632|"~     This randomized phase III trial studies compliance to a mercaptopurine treatment intervention~     compared to standard of care in younger patients with acute lymphoblastic leukemia in~     remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take~     their medications as prescribed may help them in taking their medications more consistently~     and may improve treatment outcomes.~   "
157570|NCT01503619|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tumor tissue and blood samples from~     patients with small cell lung cancer registered on CALGB-140202.~   "
157571|NCT01503606|"~     The purpose of this study is to compare the neonatal outcome and infant neurologic outcome~     whose mother were treated with cefazolin plus clarithromycin for one week or until delivery~     after preterm premature rupture of membrane.~   "
157572|NCT01503593|"~     The study was designed to assess the effectiveness of conservation ridge preservation~     (horizontal and vertical dimension) after tooth extraction with and without combination of~     bone substitutes based on synthetic (calcium sulfate mixed with phosphate.~   "
157573|NCT01503580|"~     Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the~     etiology of OAB was complicated and unclear in many aspects. In particular, the research~     about psychiatric aspect of etiology in OAB was paucity. Besides, research about prognostic~     factors and impact of cardiovascular system of OAB treatment was also paucity. Therefore the~     aims of the investigators study were (1) to analyze the etiology of OAB in psychiatric~     aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to~     analyze the differences of cardiac conduction and heart rate variability before and after~     tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-OAB~     and OAB female patients, and before and after tolterodine treatment.~   "
157574|NCT01503567|"~     This study is conducted in Africa and Asia. The aim of this study is to evaluate in the~     participating countries the orthopaedic status and the degree of arthropathy of severe~     haemophilia patients in general.~   "
157575|NCT01503554|"~     In an effort to improve care coordination and reduce hospital readmissions, Rush University~     Medical Center developed the Combined Social Worker and Pharmacist Program, which targets~     both the psychosocial and clinical risk factors that can lead to rehospitalization. This~     study will evaluate the impact of this program on 30-day same hospital readmission rates and~     total cost of care.~   "
157576|NCT01503541|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the~     laboratory may help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with acute myeloid~     leukemia treated with standard chemotherapy with or without gemtuzumab ozogamicin.~   "
157577|NCT01503528|"~     This study is designed to determine if one anaesthetic modality, either motor sparing nerve~     block or peri-articular local infiltration anaesthesia with infusion, is superior in~     providing postoperative analgesia following total knee joint arthroplasty and if the efficacy~     of analgesia affects TKA outcomes. These outcomes include pain and function for a period of~     up to 3 months, narcotic consumption, and specific non-pain complications, including cardiac,~     respiratory, central nervous system, thromboembolism, infection, nausea and vomiting and~     urinary retention.~      Economic outcomes will also be examined, including length of hospital stay, direct health~     care costs and patient satisfaction.~   "
157578|NCT01503515|"~     This randomized phase III trial studies how well caspofungin acetate works compared to~     fluconazole or voriconazole in preventing fungal infections in patients following donor stem~     cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in~     preventing fungal infections in patients following donor stem cell transplant. It is not yet~     known whether caspofungin acetate is more effective than fluconazole or voriconazole in~     preventing fungal infections in patients following donor stem cell transplant.~   "
157579|NCT01503502|"~     It is an open-label, randomized, multi-center study. The efficacy and safety of two~     flumatinib doses, 400 mg once daily and 600 mg once daily, will be compared with imatinib 400~     mg once daily in newly diagnosed (within 6 months) patients with Philadelphia~     chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).~   "
157580|NCT01503489|"~     The present study aimed at identifying clinical risk factors for switch into (hypo)mania or~     mixed states, within 8 weeks after introduction of an antidepressant or after increasing its~     dosage.~   "
157602|NCT01503203|"~     The purpose of this study will be assess the effectiveness of the physical virtual training~     on nonspecific chronic low back pain, body balance, functional autonomy and mood of older~     women. Two groups will be formed. One will do strength exercises and core training. The other~     group will do the same exercises more virtual activities with Nintendo Wii. Will be measure~     pre and post-intervention of the responses already shown above.~   "
157603|NCT01503190|"~     This study plans to learn more about the immune system's response to breast cancer in young~     women.~   "
157581|NCT01503476|"~     Study Hypothesis:~      This study is designed as an integral part of the development of new or improved features or~     components of the Bravo® pH Monitoring System and may serve verification and validation~     purposes The study population will include a group of healthy volunteers (Group A) and a~     group of symptomatic patients with known or suspected gastroesophageal reflux disease (Group~     B).~      Group A: Healthy volunteers will not undergo invasive procedure. These volunteers may be~     asked to carry the capsule and\or Bravo Recorder. These procedures will serve to evaluate~     different technical matters such as human interface, ergonomic aspects and communication~     performances of the system Group B: Symptomatic patients will undergo invasive procedure,~     including Bravo capsule delivery, positioning and attachment. Confirmation of capsule~     attachment may be done by endoscopically.~      These procedures will serve to evaluate overall system performance in actual clinical setup,~     for instance: Bravo Recorder performance including communication quality, human interface and~     similar, ergonomics of delivery device, pH Capsule performance, etc.~      Subjects from both study groups as well as physician may be asked to provide feedback on the~     procedure and/or document their activities during the procedure.~   "
157582|NCT01503463|"~     The purpose of this study is to evaluate whether telemonitoring of patients with chronic~     heart failure produces a reduction in the combined end point of all cause mortality and~     number of hospitalisations, and whether it improves health related quality of life. In~     addition, the trials evaluate the economic and organisational impact of the telemonitoring~     service and examine its acceptability by patients and health professionals.~   "
157583|NCT01503450|"~     The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5~     mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse~     events and ensure safety of subjects.~   "
157584|NCT01503437|"~     The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5~     mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor adverse~     events and ensure safety of subjects.~   "
157585|NCT01503424|"~     The purpose of this study is to compare the bioequivalence and characterize the profile of~     the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects~     under fed conditions and to monitor the adverse events and ensure the safety of the subjects.~   "
157586|NCT01503411|"~     The primary objective of this clinical trial is to evaluate the performance of the Nvision~     Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects~     undergoing esophagogastroduodenoscopy (EGD) and to identify work-flow and training~     implications for introducing this new imaging modality.~   "
157587|NCT01503398|"~     The purpose of this study is to compare the bioequivalence and characterize the profile of~     the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects~     under fasting conditions and to monitor the adverse events and ensure the safety of the~     subjects.~   "
157588|NCT01503385|"~     Concurrent chemoradiation (ChRT) is a standard care for unresectable stage III non-small cell~     lung cancer (NSCLC) patients with good performance status, and cisplatin/etoposide (EP)~     regimen is one of the most commonly used regimens. However, the prognosis of these patients~     is still rather poor. It has been demonstrated that Cyclooxygenase (COX)-2 plays an important~     role in the pathogenesis of lung cancer. Selective (COX)-2 inhibitors can promote~     chemosensitivity and radiosensitivity of tumor cells in preclinical trials.~      This is a single-institution, open-label, randomized phase II trial of celecoxib administered~     concurrently with cisplatin, etoposide, and radiation therapy in patients with locally~     advanced NSCLC, to determine the feasibility, activity, and toxicity of this combination on~     unresectable NSCLC, and further to examine biomarkers to predict response to the treatment.~   "
157589|NCT01503372|"~     The prognosis of advanced gastric cancer and adenocarcinoma of the gastro-esophageal (GE)~     junction is poor. Even with modern chemotherapy the median survival ranges around 8-10~     months.~      Inhibition of neoangiogenesis seems to be a very promising approach in gastric cancer.~      Vascular endothelial growth factor (VEGF) acts as one of the most potent stimulating agents~     of angiogenesis, and several strategies targeting the VEGF signaling pathway have been~     developed, including anti-VEGF antibodies, soluble receptors binding directly to VEGF ligand,~     anti-VEGF receptor (VEGFR) antibodies and VEGFR tyrosine kinase inhibitors. The breakthrough~     in the clinical development of anti-angiogenic therapy against colorectal cancer came in 2003~     with a large prospective, randomized clinical trial of bevacizumab, a monoclonal antibody~     directed against VEGF. Anti-angiogenic therapy has introduced a highly effective, completely~     new mode of action in this area and is the new standard of care in advanced colorectal~     cancer.~      The concept of VEGF inhibition is also very promising in gastric cancer. Bevacizumab was~     investigated in combination with irinotecan and cisplatin in a phase-II trial, including 47~     patients with gastric and GE-junction carcinoma. Bevacizumab could safely be given and could~     improve time to tumor progression by 75% compared to historical controls. Several phase-II~     trials confirm the tolerability and promising efficacy of bevacizumab in gastric cancer~     (Bevacizumab + Docetaxel/Oxaliplatin; FOLFOX + Bevacizumab; Docetaxel/Cisplatin/Irinotecan +~     Bevacizumab). These results were so promising that randomized phase-III trials in the~     1st-line and perioperative setting are under way (AVAGAST-trial: Cisplatin /Capecitabine +/-~     bevacizumab 1st line ; MAGIC-B-trial : ECX +/- bevacizumab perioperative).~      Tyrosin kinase inhibitors which inhibit VEGF receptors and EGFR are also investigated in~     gastric cancer with promising efficacy. Pazopanib, an orally available tyrosine kinase~     inhibitor, selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, -2~     and -3, c-kit and platelet derived growth factor receptor (PDGF-R), which results in~     inhibition of angiogenesis in tumors in which these receptors are upregulated. Pazopanib has~     the advantage of being an orally available anti-angiogenesis component.~      Pazopanib shows promising activity in phase-II trials in renal cell cancer, breast cancer,~     soft tissue sarcoma and non small cell lung cancer. A phase-III trial of pazopanib in renal~     cell cancer (NCT00334282) is completed and resulted in the approval of Pazopanib for this~     disease. A phase-III trial in soft tissue sarcoma (NCT00753688) is currently performed.~      In phase-I trials, pazopanib was investigated in combination with FOLFOX and~     Capecitabine/Oxaliplatin. FOLFOX could be administered in full dose with 800 mg pazopanib. In~     Cape/Ox, capecitabine had to be reduced to 850mg/m² bd.~      5-FU- and oxaliplatin-based regimens are one of the established treatment standards for~     1st-line therapy in metastatic gastric cancer. The efficacy of 5-FU, leukovorin and~     oxaliplatin (FLO) compared to 5-FU, cisplatin could be confirmed in a randomized phase-III~     trial of the Arbeitsgemeinschaft Internistische Onkologie (AIO). FLO has a favorable toxicity~     profile. In Germany, FLO is a widely used combination for advanced gastric cancer and is a~     recommended regimen in the new German S3-guidelines 2011.~      The investigators therefore want to examine FLO + pazopanib.~   "
157590|NCT01503359|"~     The purpose of study is to determine whether dietary supplement sarcosine is effective in~     treatment of schizophrenia. The investigators will assess impact of sarcosine on quality of~     life and sexual functioning. In this project the investigators will also measure glycine,~     sarcosine, BDNF, MMP-9 levels and oxydative stress parameters in blood, brain glutamatergic~     metabolism parameters in magnetic resonance spectroscopy and oculomotoric changes in~     electrooculography.~   "
157591|NCT01503346|"~     Appetite loss is a severe and common symptom among late-stage cancer patients, and it causes~     great the anxiety for the patient's family. In TCM theory, the investigators call these~     patients are in block and repulsion condition. The investigators try to set a study to use~     the herbal medicine solution taken in frequent small amounts by cancer patients in late-stage~     to improve the appetite loss condition. Through this method, the investigators not only want~     to improve the quality of life of cancer patients in late-stage but also set a valuable~     treatment.~   "
157592|NCT01503333|"~     The purpose of this school-based trial is to test the efficacy of an intervention to increase~     moderate to vigorous physical activity (MVPA) among middle school girls. The 17-week Girls~     on the Move (GOTM) intervention has 3 components. Two individual-level components occurring~     during school hours include: (1) two face-to-face motivational, individually tailored~     counseling sessions with a school nurse, and (2) an interactive Internet-based session during~     which each girl receives motivational, individually tailored feedback messages (at 9 weeks).~     A group-level component, 90-minute Physical Activity (PA) Club provides an important venue~     after school that includes activities to assist girls in establishing a behavioral pattern of~     MVPA. The control condition will complete data collection activities and receive their usual~     school offerings.~      The investigators hypothesize that immediately post-intervention, minutes of MVPA will be~     greater by 16 min./wk. in the intervention than control group; At 9 months post-intervention~     follow-up, minutes of MVPA will be greater in the intervention than control group; and~     immediately post-intervention and 9-mo. post-intervention follow-up, cardiovascular (CV)~     fitness will be higher and body mass index (BMI) and percent body fat will be lower in the~     intervention than control group.~   "
157604|NCT01503177|"~     This phase I clinical trial investigates the side effects and the best dose of local~     (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma~     (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles virus~     will enable the virus to specifically infect and kill cancer cells and spare, without~     damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an~     anti-tumor immune response which will result in additional destruction of the tumor by immune~     cells~   "
157593|NCT01503320|"~     Acute pancreatitis (AP) is a potentially serious illness characterized by inflammation of the~     pancreas with variable involvement of peri-pancreatic tissues and/ or remote organ systems.~     AP is hyper catabolic condition due to systemic inflammatory response syndrome (SIRS without~     any proven specific treatments. Therefore, current therapy for AP is directed to intensive~     medical care, nutrition support and infection control.~      Nutritional support is very crucial in the treatment of AP. Enteral nutrition (EN) is the~     preferred modality since parenteral nutrition is associated with various complications. EN~     could preserve the intestinal permeability, which would be the best barrier for prevention of~     certain complications.~      Glutamine is the most abundant free amino acid in the body and is used as a major fuel and~     nucleotide substrate. When a nutritional deficiency arises in critical illness including SAP,~     glutamine tends to be conditionally depleted.~      We hypothesize that enteral glutamine supplementation in patients with severe and predicted~     severe acute pancreatitis helps in their early recovery and prevention of adverse outcomes.~      In this study, we aim to evaluate the therapeutic effect of enteral glutamine on clinical~     outcomes, gut permeability, systemic inflammation, oxidative stress and plasma glutamine~     levels.~   "
157594|NCT01503307|"~     The purpose of this research study is to learn about parents' experiences following diagnosis~     of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other health-care~     clinicians will benefit from an improved understanding of what the diagnosis means to parents~     and what they expect concerning the infant, being a parent, and caregiving tasks and~     responsibilities. The investigators expect that the knowledge gained will increase~     clinicians' ability to respond to parents' needs.~   "
157595|NCT01503294|"~     Assessment and evaluation of body temperature is an important sign of health and disease.~     Inferior thermometry increases the risk of morbidity and mortality, and increases health care~     cost by delaying the diagnosis and treatment of fever-related disease. The gold standard for~     measuring core body temperature is the pulmonary artery thermistor (PAT). The measurement of~     the PAT requires the insertion of the invasive pulmonary artery catheter, a high risk~     procedure.~      An innovative thermometry technology, the temporal artery thermometer (TAT), has been~     introduced into the clinical arena as a potential non-invasive proxy for the PAT. The TAT~     reduces the risk and cost of pulmonary artery catheter insertion by non-invasively measuring~     core blood temperature by measuring temperature over the skin of the temporal artery.~      Research to demonstrate the precision and accuracy of the TAT in normothermic patients has~     been published, but little to no data is available in those with temperatures greater than~     100.4oF. The purpose of this study is to measure the precision and accuracy of 2standard of~     care temperature methods: the thermistor from the PAT, considered the gold standard, and the~     TAT as measured in those patients with a PAT temperature greater than 100.4oF.~   "
157596|NCT01503281|"~     The aim of this study was to compare the effect of a hospital group-based vs. home-based~     combined exercise-diet program for the treatment of childhood obesity.~   "
157597|NCT01503268|"~     Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with~     medications, but these are not always effective or tolerated. Ablation is a well-recognised~     technique that is recommended for those with symptomatic AF who have failed medical therapy.~      Ablation can be performed in a number of ways. In percutaneous ablation, ablation is~     performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic~     ablation, ablation is performed under general anaesthetic via very small incisions in the~     chest wall.~      Because AF can be intermittent, the only reliable way to look for it is with long-term ECG~     monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs).~      In this study, the investigators are trying to see if minimally-invasive thoracoscopic~     ablation is better than percutaneous ablation, and in turn if they are better than Direct~     current cardioversion (DCCV), using ILRs to monitor AF.~   "
157598|NCT01503255|"~     This study will determine whether a group cognitive-behavioral therapy intervention that~     demonstrates preliminary evidence of reducing alcohol use among HIV-infected outpatients in~     western Kenya is effective when compared against a group health education intervention in a~     large sample over a longer period of time. It will be delivered by paraprofessionals,~     individuals with limited formal education and little or no relevant professional experience.~     This approach is consistent with successful cost-effective models of service delivery in~     resource-limited settings in which paraprofessionals (e.g., clinical officers, traditional~     birth attendants and peer counselors) are trained.~   "
157599|NCT01503242|"~     This phase I trial studies the side effects and best dose of yttrium Y 90 anti-CD45~     monoclonal antibody BC8 when given together with fludarabine phosphate and total-body~     irradiation followed by donor peripheral blood stem cell transplant in treating patients with~     multiple myeloma. Radiolabeled monoclonal antibodies, such as yttrium Y 90 anti-CD45~     monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them~     without harming normal cells. Giving chemotherapy drugs, such as fludarabine phosphate, and~     total-body irradiation before a donor peripheral blood stem cell transplant helps stop the~     growth of cancer cells and helps stop the patient's immune system from rejecting the donor's~     stem cells. When the healthy stem cells from a donor are infused into the patient they may~     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells. Giving yttrium Y 90 anti-CD45 monoclonal antibody BC8, fludarabine~     phosphate, and total-body irradiation before the transplant together with cyclosporine and~     mycophenolate mofetil after the transplant may stop this from happening and may be an~     effective treatment for multiple myeloma.~   "
157600|NCT01503229|"~     This phase II trial studies how well abiraterone acetate works in treating patients with~     hormone-resistant prostate cancer that has spread from the primary site (place where it~     started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
157601|NCT01503216|"~     The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured~     by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively,~     and by total 25(OH)D.~   "
157618|NCT01502995|"~     The purpose of this study is to determine whether a laser light beam, attached to a rolling~     walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's~     disease.~   "
157605|NCT01503164|"~     Obstructive sleep apnea affects approximately 2-4% of middle-aged adults in the general~     population and is associated with several medical conditions including hypertension and~     coronary artery. Research over the last decade has shown that obstructive sleep apnea may~     also increase the propensity for insulin resistance, glucose intolerance, and type 2 diabetes~     mellitus. Positive airway pressure (PAP) is the first line therapy for the treatment of~     obstructive sleep apnea. While PAP therapy has several favorable effects such as improvements~     in daytime sleepiness and quality of life, it is not clear whether using PAP therapy can~     alter metabolic risk. The overall objective of this study is to examine whether treatment of~     obstructive sleep apnea with positive airway pressure therapy improves glucose tolerance and~     insulin sensitivity. The primary hypothesis of this study is that PAP therapy of obstructive~     sleep apnea will improve in insulin sensitivity and glucose metabolism.~   "
157606|NCT01503151|"~     Adults with Social Phobia will be randomly assigned to either an attention bias modification~     treatment, interpretation bias modification treatment, both, or a placebo control condition~     not designed to change cognitive bias patterns.~      Outcome measures will be social anxiety symptoms and severity as measured by gold standard~     questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from~     structured clinical interviews based on DSM-IV criteria.~      The investigators expect to find significant reduction in social anxiety symptoms in the~     Treatment groups relative to the placebo control group. The investigators want to find out~     the relative efficacy of attention and interpretation oriented treatments and the combination~     of the two.~   "
157607|NCT01503138|"~     The purpose of this study is to evaluate the efficacy of a purpose-built intervention in~     improving the mental health of abused Mainland Chinese immigrant women in a community in Hong~     Kong.~   "
157608|NCT01503125|"~     Giant Axonal Neuropathy (GAN) is a devastating and rare childhood disease. Children with GAN~     develop increasing muscle weakness, impaired sensation, and at times mental retardation. GAN~     starts in infancy, leads to significant disability, and typically leads to death within the~     first 30 years of life. GAN is caused by a defect in the gigaxonin (GAN) gene, resulting in~     pathologically enlarged and dysfunctional nerves. Currently, there is no effective therapy.~     To find out what medications can help patients with GAN, the investigators have to conduct~     clinical trials. In this study, the investigators propose to prepare for future clinical~     trials and will invite GAN patients to join our research effort.~      The investigators will examine them regularly to better understand their disease. The visits~     will include questions, a physical exam, blood drawing, a lumbar puncture, and a skin biopsy.~     The visits will also include tests that assess the electrical conductivity of the patients'~     nerves as well as a test to measure the patients' brain wave activity. In addition, the~     investigators will be performing tests to evaluate the patients' motor function, their~     vision, and thinking ability. Identifying an effective GAN treatment is very important~     because there is currently none. Clinical trials are the only way to decide whether a new~     treatment works in GAN patients or not.~      With the future objective of conducting clinical trials in GAN, the proposed project has~     three specific aims. The first is to plan for clinical trials by developing reliable outcome~     measures, and establishing the infrastructure needed to carry out efficient clinical trials.~     The second is to further characterize the patient population from a clinical and molecular~     point of view, and the third aim is to utilize the information gathered in this study to~     further pre-clinical GAN drug development to select candidate drugs.~   "
157609|NCT01503112|"~     Type 2 diabetes is a major and rapidly increasing health problem worldwide. Keeping the blood~     glucose (sugar) from going too high helps prevent complications. Recently a number of new~     treatments (collectively called 'incretin based' treatments) to lower blood glucose have~     become available but response is very variable and it is difficult to predict which will work~     for an individual. The investigators want to see if we can identify whether the new~     treatments are likely to be effective for an individual patient. Identifying the right~     treatment would improve control and minimise the side-effects and costs from ineffective~     treatments. We will collect blood (for measures of blood glucose, insulin secretion and~     genetics information), urine (for a simple measurement of insulin secretion) and other~     clinical information (such as weight,age, duration of diabetes and medication) in people who~     are about to start these new 'incretin based' treatments and assess their response over the~     first 6 months of treatment. We will analyse this information to see if we can predict~     treatment response.~      Study Hypothesis:~      The investigators hypothesise that those who have low insulin secretion, as measured by post~     meal urine C-peptide Creatinine Ratio or blood C-peptide, will have poor blood glucose~     response to incretin based treatments.~   "
157610|NCT01503099|"~     One aims to devise a method for the screening and differentiation of intestinal tuberculosis~     and Crohn's Disease. Additionally, one aims to detect and survey multidrug resistant TB.~   "
157611|NCT01503086|"~     This randomized clinical trial studies how well an adaptive computerized cognitive training~     program works compared to a non-adaptive computerized cognitive training program in treating~     younger patients with brain tumor who underwent radiation therapy. Providing a computer~     training program may improve the well-being and quality of life of patients with cognitive~     (physical and mental) function difficulties caused by radiation therapy to the brain.~   "
157612|NCT01503073|"~     Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a~     variety of functions.~   "
157613|NCT01503060|"~     The aim of this study is to find out the effects of routinely using different types of~     pain-relieving strategies during routine immunization injections performed in infants.~   "
157614|NCT01503047|"~     The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and~     t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals~     who maintained their normal dietary and exercise patterns.~   "
157615|NCT01503034|"~     This is a non-interventional, retrospective, multicentre study involving women having had a~     breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and~     non-pregnant women having had a breast cancer between 2000 and 2009 (controls).~   "
157616|NCT01503021|"~     The purpose of the parent study is to assess the short-term safety and tolerability of~     soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of~     representative adult chronic kidney disease patients on hemodialysis (CKD-HD).~      The purpose of the extension study is to assess the long-term safety and tolerability of SFP.~   "
157617|NCT01503008|"~     The study will test whether the Proteus Sustained Behavior Change (SBC) System will help Type~     2 diabetics feel more able to perform self-care activities, feel less distressed about~     diabetes, and reduce mean fasting blood glucose levels. The SBC system uses ingestible and~     wearable sensing devices and mobile phones to reinforce positive behaviors around medication~     usage, exercise and rest.~   "
198131|NCT00969618|"~     The purpose of this study is to assess long-term safety and tolerability in adult patients~     who have completed a previous atomoxetine study.~   "
157619|NCT01502982|"~     The purpose is to test whether dose densified chemoimmunotherapy followed by central nervous~     system (CNS) prophylaxis for young high risk diffuse large B-cell lymphoma (DLBCL) patients~     is feasible and could improve time to treatment failure and reduce the risk of CNS relapses.~     Six courses of rituximab-cyclophosphamide-doxorubicin-etoposide-vincristine-prednison~     (R-CHOEP) given in two weeks intervals with the support of G-CSF is followed by one course of~     high dose methotrexate (HD-MTX) and high dose cytarabine (HD-Ara-C). The results will be~     compared to a historical Nordic study.~   "
157620|NCT01502969|"~     This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety~     and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of~     Vaccines and Biologicals, Vietnam.~   "
157621|NCT01502956|"~     The purpose of this randomized, open-label, active-control trial is to compare the~     effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral~     neuromodulation (InterStim®, Medtronic) for the treatment of refractory urge urinary~     incontinence. In addition, the study will evaluate select technical attributes of the~     interventions as well as the effect of these two interventions on other lower urinary tract~     and pelvic floor symptoms.~      Hypothesis: InterStim® therapy will result in a greater reduction in daily urge urinary~     incontinence episodes over the 6-month follow-up period as compared to Botox A® injection.~      A supplemental study investigates whether biological markers including those related to~     inflammation and connective tissue remodeling change following treatments with Botox A® and~     Interstim®.~   "
157622|NCT01502943|"~     The purpose of the trial is to take stable angina pectoris of coronary heart disease (CHD) as~     examples to build a standard evaluation system for efficacy of traditional Chinese medicine~     (TCM).~        1. Studies of evaluating reliability, validity and reactivates of Patients Report Outcomes~          of CHD and self-administrated scale of Stable Angina Pectoris~        2. research on all indicators of CHD, and analyze their characteristics, target and~          function~        3. theory of Invigorating Spleen to Remove Phlegm or replenish Qi, and activating blood and~          dissolving stasis as an example for clinical efficacy evaluation.~   "
157623|NCT01502930|"~     This study is a randomized controlled trial (RCT) to evaluate the effect of an~     internet-based, guided self-help treatment of reoccurring and distressing nightmares. Imagery~     Rehearsal Therapy (IRT) will be compared to an active control treatment (CONT) and a~     recording-only group (REG). It is hypothesized that both active treatments will be superior~     to REG, and that IRT will be superior to CONT.~   "
157624|NCT01502917|"~     The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic~     Pontine Glioma (DIPG). The researchers will use convection-enhanced delivery (CED) to~     deliver an agent called 124I-8H9. CED is performed during surgery. The study agent is infused~     through a small tube placed into the tumor in the brain. Many studies have shown this can~     safely be done in animals but this study is the first time 124I-8H9 will be given by CED in~     humans. This will be one of the first times that CED has been performed in the brain stem.~      8H9 is something called an antibody. Antibodies are made by the body to fight infections and~     sometimes cancer. The antibody 8H9 is produced by mice and can attack many kinds of tumors. A~     radioactive substance, 124I, is attached to 8H9. 124I-8H9 sticks to parts of tumor cells and~     can cause the tumor cells to die from radiation. Studies have also been done on humans using~     124I-8H9 to treat other kinds of cancer. Our studies of some DPG and related tumors suggest~     that 8H9 will bind to the tumor, but the investigators don't know that for sure.~      In this study, the researchers want to find out how safe 124I-8H9 given by CED is at~     different dose levels. They will look to see what effects (both good and bad) it has on the~     patient. The dose of 124I-8H9 will increase for each new group of patients. The procedure has~     already been safely performed with lower doses and infusion volumes in a number of patients~     here at MSKCC. The amount they get will depend on when they enter the study. If too many~     serious side effects are seen with a certain dose, no one will be treated with a higher dose,~     and some more patients may be treated with a lower dose to make sure that dose is safe.~   "
157625|NCT01502904|"~     There has been little research on neointimal coverage and malapposition after BES~     implantation using OCT in human coronary artery. Furthermore, specific drug may possibly~     influence the vascular healing after stent implantation. Therefore, this study will~     investigate 1) neointimal coverage and malapposition on OCT after BES versus SES implantation~     and 2) relationship of specific drug treatment and neointimal coverage or late malapposition~     by the prospective, randomized study.~   "
157626|NCT01502891|"~     The purpose of this study is to determine whether the Depression Medication Choice decision~     aid is effective in involving patients with depression in making deliberate choices when~     considering medication treatment.~   "
157627|NCT01502878|"~     Nut sensitization in skin prick tests is common in areas, including Finland, where birch~     pollen is abundant. However, sensitization to nuts in skin prick test does not predict the~     possibility of allergic symptoms when nuts are ingested. In this study the investigators~     launch and perform double-blind placebo-controlled nut challenges and oral desensitization/~     protocol to those with serious symptoms in the challenge. The efficacy and safety of the new~     oral desensitization program is the primary outcome. The effect of oral desensitization on~     bronchial hyperreactivity, eosinophilic airway inflammation, and quality of life are~     secondary outcomes.~   "
157628|NCT01502865|"~     The overall objective of this project is to conduct a feasibility study using data proved by~     Department of Defense National Center for Telehealth and Technology (T2) toward the ultimate~     goal of establishing a mechanism by which VA clinicians could access data on Veterans~     regarding suicidal thoughts and/or behaviors that occurred when they were on active duty, as~     documented in the Department of Defense Suicide Event Report (DoDSER).~   "
157629|NCT01502852|"~     The purpose of this study is to explore and potentially increase the capacity of the non-VA~     community mental health system within the state of Colorado to provide a comprehensive and~     coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi~     Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF~     Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health~     issues.~   "
157663|NCT01502410|"~     This phase II trial studies how well sorafenib tosylate works in treating younger patients~     with relapsed or refractory rhabdomyosarcoma, Wilms tumor, liver cancer, or thyroid cancer.~     Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~   "
157630|NCT01502839|"~     The purpose of this study is to examine differences in post-concussive (PC) symptom~     endorsement among four groups of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom~     (OIF) Veterans: those with a history of target, service-related, mild traumatic brain injury~     (mTBI) and co-occurring posttraumatic stress disorder (PTSD) (Group 1); those with a history~     of target, service-related, mTBI only (Group 2); those with PTSD only (Group 3); and those~     with no history of target, service-related, mTBI or PTSD (Group 4) by examining scores on the~     Neurobehavioral Symptom Inventory (NSI). Support for this study is provided by previous~     research highlighting the complex relationship between mTBI, PTSD and subsequent PC symptom~     endorsement (Brenner et al. 2010; Terrio et al, 2009).~      HYPOTHESES ARE AS FOLLOWS:~        1. Individuals with a history of target, service-related, mTBI only (Group 2) and~          individuals with PTSD only (Group 3) each will report significantly more PC symptoms, as~          measured by NSI total scores, when compared to those with no history of service-related~          mTBI or PTSD (Group 4).~        2. Individuals with co-occurring target, service-related, mTBI history and PTSD (Group 1)~          will report significantly more PC symptoms, as measured by total NSI scores, than either~          those with target, service-related, mTBI only (Group 2) or those with PTSD only (Group~          3).~   "
157631|NCT01502826|"~     Childhood obesity is increasing at a fast pace, together with its complications. The aim of~     the present study is to assess several candidate triggering agents, mechanisms and~     intermediate phenotypes of atherosclerosis during the post-prandial phase in the obese~     insulin-resistant child/adolescent.~   "
157632|NCT01502813|"~     The purpose of this study is to determine the functional effects of a citicoline, creatine,~     and omega-3 fatty acids combination when administered for a duration of four weeks (28 days)~     to non-psychiatric adult female participants.~   "
157633|NCT01502800|"~     Primary Objective:~      To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 761~     administered intravenously.~      Secondary Objectives:~      To determine the pharmacokinetic profile of ARQ 761 To assess the preliminary anti-tumor~     activity of aRQ 761~   "
157634|NCT01502787|"~     The purpose of this study is to determine if Nebivolol a) attenuates the angiotensin II (Ang~     II)-induced increase in oxidative stress, thereby attenuating Ang II-induced~     vasoconstriction; and b) attenuates sympathetic mediated vasoconstriction during exercise,~     thereby reducing functional skeletal muscle ischemia in hypertensive patients.~   "
157635|NCT01502774|"~     Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The~     investigators recently reported that cyclosporine A, when administered immediately prior to~     percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST~     Elevation acute Myocardial Infarction) patients. The objective of the present study is to~     determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and~     seventy two patients with ST elevation MI will be entered into a multicentre, randomized,~     placebo-controlled, double-blinded study. They will receive one single injection of~     cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion~     therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart~     failure, left ventricular (LV) remodeling) will be assessed at one year and three years after~     treatment.~   "
157636|NCT01502761|"~     Stroke is the second leading cause of death and the leading cause of adult disability~     worldwide. This investigation will address the safety and feasibility of directed,~     intra-arterial Magnesium measurement and therapy, through endovascular access, in acute~     stroke patients. The proposal represents the first study to directly quantify levels of a~     systemically administered neuroprotectant in the region of cerebral ischemia. It also~     establishes a novel endovascular platform for direct delivery of neuroprotective agents to~     ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve~     patient care by establishing a novel delivery mechanism for the rescue of threatened brain~     parenchyma that can be administered rapidly following acute stroke. If successful, this~     selective distribution will allow delivery to at risk tissue in a rapid manner. Salvage of~     viable, but threatened, penumbral tissue could afford stroke patients an increased~     probability of favorable long term outcome. The investigators hypothesize that endovascular,~     intra-arterial, Magnesium administration will deliver high concentration of this~     neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic~     concentrations. The proposed investigation will evaluate the safety and feasibility of this~     novel treatment technique~   "
157637|NCT01502748|"~     This investigation will address the safety and feasibility of distal, intra-arterial sampling~     through endovascular access, in acute stroke patients. Levels of Magnesium will be measured~     in the region of infarct in patients who had been treated with intravenous Magnesium therapy~     following an acute stroke. This study attempts to address whether the traditional intravenous~     means of neuroprotectant administration achieves adequate concentration of the therapeutic~     agent in the area of diseased tissue.~   "
157638|NCT01502735|"~     This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention~     of dengue fever.~   "
157639|NCT01502722|"~     The purpose of this study is to determine if regular soft drinks (with sugar) have the same~     effect on thirst as diet soft drinks(with sweeteners).~   "
157640|NCT01502709|"~     The investigators propose to conduct a randomized blinded placebo-controlled clinical trial~     in patients with chronic TMD (N=20). Patients will be randomly assigned to receive either~     active treatment (caloric vestibular neurostimulation) or placebo. Data will be collected~     prior to and after treatment on thermal and mechanical pain thresholds, clinical signs and~     symptoms of TMD, and any adverse events.~   "
157641|NCT01502696|"~     Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk~     for relapse than patients with a non-ulcerated primary and about a 40-50% chance of~     developing stage IV disease to which they will almost invariably succumb. In stage I and II~     patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be~     SN-negative there is still a 25-30% relapse risk.~      The purpose of this study is to evaluate the effectiveness and safety when treated with PEG~     IFN alfa-2b for 2 years as compared to observation (no treatment), administered after~     adequate surgery has been performed for ulcerated primary cutaneous melanomas.~   "
158806|NCT01487421|"~     This study is conducted in Europe. The aim of this study is investigate the potential of a~     supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled~     patients with type 2 diabetes in a normal diabetes care setting.~   "
157642|NCT01502683|"~     One of the most devastating complications of coronary artery bypass surgery (CABG) is~     postoperative stroke. While there are multiple causes of stroke after CABG, particles~     generated during handling of the aorta is believed to account for most neurologic effects.~     Handling of the aorta during CABG occurs several times during the operation. One strategy to~     reduce aortic handling is to avoid cardiopulmonary bypass altogether by using off-pump~     techniques (OPCAB). Another method is to avoid the use of aortic clamps and/or to use devices~     that do not require aortic clamping. This study will test the hypothesis that an off-pump~     (OPCAB) approach and devices to perform clampless surgery will result in the least amount of~     aortic handling and therefore the lowest incidence and frequency of neurologic adverse~     events.~   "
157643|NCT01502670|"~     This study will look at how the [18]FACBC goes into the lung nodules. This will hopefully~     lead to the development of better imaging techniques to look at lung nodules. [18]FACBC is~     not approved by the FDA (Food and Drug Administration). This study will help to determine if~     it should be approved by the FDA.~   "
157644|NCT01502657|"~     The purpose of this study is to determine the feasibility and the safety of ultrasound guided~     percutaneous dilatational tracheostomy.~   "
157645|NCT01502644|"~     Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such~     as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain~     patients (and is termed comorbid negative affect [NA]). The purpose of the study is to~     determine whether CLBP patients with either a high vs. a low or moderate degree of NA have~     different pain relief responses to oral opioids.~   "
157646|NCT01502631|"~     The purpose of this research study is to gather scientific information about the~     effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive~     substance) in subjects with acute spinal cord injury.~   "
157647|NCT01502618|"~     This study involves conducting formative research to develop a culturally appropriate~     secondary prevention intervention for HIV-positive Black young men who have sex with men~     (B-YMSM). The intervention draws upon the principles of Critical Consciousness Theory (CCT).~     The formative research includes reviewing data and findings from relevant ATN protocols~     (i.e., 070, 068, and 073) and existing health promotion interventions targeting young men of~     color (i.e., the Young Warriors program, Hermanos de Luna y Sol [HLS]) and conducting focus~     groups with up to 32 HIV- positive B-YMSM.~   "
157648|NCT01502605|"~     This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA)~     (also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this~     study is to determine if 5-ALA can differentiate between tumor and normal brain tissue.~      Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the~     tumor can look like normal brain tissue. Studies in other countries have shown that in some~     brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may~     make it easier for doctors to remove as much tumor as safely as possible from your brain.~      This study also hopes to see if 5-ALA can find different cell populations within the tumor~     that is removed and allow the researchers to better understand brain tumors.~      The purpose of this study is to:~        -  Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see~          how well 5-ALA can find different cell populations within brain tumors~        -  Identify the amount of 5-ALA that should be taken before surgery to make the tumors glow~          under ultraviolet light~        -  Make sure the 5-ALA identifies tumor and not normal brain~        -  Make sure 5-ALA does not cause any side effects~   "
157649|NCT01502592|"~     This study is being done to evaluate the safety of two strategies called cryoablation and~     immune therapy in women with curable early stage breast cancer. Cryoablation is a~     procedure performed by an expert doctor called a radiologist. The radiologist uses (magnetic~     resonance imaging (MRI) to insert a needle directly into a cancer. Very cold temperatures are~     then applied through the needle to kill the cancer cells. Some of the killed cancer cells~     will be broken into pieces that can be recognized by a person's immune system.~      The immune therapy in this study is a drug called ipilimumab. Normally the immune system~     makes T cells that can kill cancer cells when turned on. The cancer-killing T cell activity~     is controlled by a molecule called CTLA4. Ipilimumab works by turning off CTLA4. Turning off~     CTLA4 allows the cancer-fighting T cells to remain active Ipilimumab is an antibody drug has~     been made in a laboratory for patient use and was recently approved by the United States Food~     and Drug Administration (FDA) for the treatment of patients with a type of skin cancer called~     melanoma. An antibody is a normal protein that the immune system uses to find and kill germs~     like bacteria and viruses. This study is being done because the researchers believe that when~     cryoablation is combined with immune therapy, a person's immune system can be trained to~     recognize that person's cancer. This may prevent that cancer from coming back in the future.~     In other words, it is hoped that by adding cryoablation with ipilimumab before the~     mastectomy, the body will remain cancer free long after the mastectomy is performed. The~     first step in determining whether cryoablation and immune therapy can be used to cure breast~     cancer is to evaluate the safety of each strategy alone and then in combination in a small~     group of patients.~   "
157650|NCT01502579|"~     The pathological variants of IgA nephropathy identified by the Oxford classification may be~     related to the clinical data at presentation and follow-up, including proteinuria and renal~     function. This study is aimed to identify the potential relationship between pathological~     variants and clinical data in IgA nephropathy.~   "
157651|NCT01502566|"~     Objective:~      The aim of this study is to assess the effectiveness of an oral health educative intervention~     in preventing early childhood caries (ECC).~      Methods:~      The trial targets 0- to 12-month-old children and their mothers in Pelotas, Brazil.~     Twenty-four public health centres (clusters) were randomly selected and assigned to~     intervention or control group (12 clusters per intervention group). In each center, up to 30~     children/mothers were selected and invited to participate in the trial. Each mother was~     interviewed in order to collect socio-economic and demographic variables. The intervention~     group received by means of a pamphlet the oral health instructions, which were emphasized~     with verbal instructions. Dental examination will be carried out after 1 year for all teeth~     surfaces to determine caries status.~   "
157664|NCT01502397|"~     The purpose of this study is to determine whether preemptive nucleoside analogue therapy or~     regular virologic monitoring is the preferred method in management patients with prior~     exposure to hepatitis B vius (HBV) and undergoing rituximab-containing chemotherapy.~   "
157652|NCT01502553|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the function of device.~        2. Test methods and procedures: Performance test in two positions: Seated and Supine.~        3. DUT: Transtek Blood Pressure Monitor, Model: LS-802. Cuff size: 22-32 cm and 22-42 cm.~        4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and~          range: 0-300 mmHg.~        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Meet the requirements of SP10.~   "
157653|NCT01502540|"~     Craniotomies are generally thought to be less painful than other operations. Indeed recent~     studies have confirmed that pain is a common problem during the postoperative phase following~     craniotomy.Pain not only causes discomfort, but it is also associated with other potential~     adverse events such as increased sympathetic activity and elevated systemic blood pressure.~     These events in turn may contribute to increased intracranial pressure. Some patients may~     also develop chronic pain.Potent opioids have been avoided due to its potential to cause~     respiratory depression and risk of masking pupillary signs. As a result postoperative~     craniotomy pain controls are usually inadequate.~      In Siriraj hospital, there are 500-600 craniotomy patients per year. Still there are no~     definite guidelines for postoperative pain management in these patents due to lack of~     information about quality of postoperative pain control after craniotomy.~      Objectives~      Primary objective :~      - To study incidence of moderate to severe pain during first 48 hours after craniotomy.~      Secondary objectives :~        -  To determine risk factors for moderate to severe pain during first 48 hours after~          craniotomy~        -  To evaluate side effects and complications of postoperative craniotomy pain control~        -  To compare patient's expectation for pain management before and after surgery~        -  To determine patient's satisfaction for postoperative pain management~   "
157654|NCT01502527|"~     Based on previous data published on the SERM properties of Femarelle, the investigators~     hypothesized that Femarelle could be a potential treatment for Vulvo-vaginal atrophy(VVA)~     symptoms. The current study was a pilot study to examine the effect of Femarelle® on VVA~     symptoms in symptomatic post-menopausal women.~   "
157655|NCT01502514|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Heart Disease~          as assessed by a series of measurements indicating improvement, stability, or~          degradation of a patient's cardiovascular function and exercise capacity?~   "
157656|NCT01502501|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Heart Disease~          as assessed by a series of measurements indicating improvement, stability, or~          degradation of a patient's cardiovascular function and exercise capacity?~   "
157657|NCT01502488|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Autism.~   "
157658|NCT01502475|"~     In this protocol, the investigators proposed to assess the Complementary Alternative Medicine~     (CAM) usage patterns in a Veteran population using a CAM survey developed by Dr. Hernandez~     and colleagues. This survey, the Complementary, Alternative and Conventional Medicines~     Attitudes Scale (CACMAS), is a brief, self-report questionnaire that assesses medical use~     patterns, as well as attitudes about medical treatment and the relationship among these. The~     CACMAS will assess the potential role of individual beliefs and attitudes towards~     complementary and conventional medicine usage patterns, and possibly indicate how this scale~     might be used to predict optimal treatment offerings for a particular population given~     attitudes about medical treatments.~   "
157659|NCT01502462|"~     Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without~     significant left-sided valvular or myocardial diseases.~      Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.~   "
157660|NCT01502449|"~     This study will evaluate a telephone-delivered cognitive-behavioral psychotherapy~     intervention designed for primary care treatment of combat-exposed service members with PTSD.~     The investigators will assess Posttraumatic Stress Disorder (PTSD) symptoms, mental~     health-related and occupational functioning, and symptoms of depression, anxiety, and~     somatization.~   "
157661|NCT01502436|"~     The purpose of this study is to explore the relationship between attempted and/or completed~     suicide and reported experience of chronic pain among an adult veteran population. Specific~     aims include a) examining the experience of chronic pain between patients who have either~     attempted and/or completed suicide, non-suicide attempt mental health patients, and~     non-mental health chronic pain patients and b) determining possible differences in reported~     experiences of chronic pain based on mental and physical diagnoses, age, gender, ethnicity,~     occupation, and patient's recorded perceptions of depression and/or quality of life. As~     articulated in the Amendment approved on June 13, 2008, additional areas of interest include~     histories of neurological disease (e.g. traumatic brain injury) and/or mental health~     diagnoses. History of both neurologic disease and mental health diagnoses will also be~     identified by chart review (per approval obtained June 13, 2008). As such this study will~     also compare differences (e.g., mental health, neurological disease) between veterans who~     have history of a suicide attempt, completion, or a lifetime history of suicidality and~     matched control veterans without a history of suicide attempts, completions, or lifetime~     history of suicide. The relationship between suicidal behavior, attempted/completed suicide,~     and reported Post Traumatic Stress Disorder (PTSD) symptoms among an adult veteran population~     is also of interest. Additionally, this data set will be used to complete a validation study~     regarding the Self-Directed Violence Classification System (SDVCS). Specifically, relevant~     information in subject chart notes regarding self-directed violence (SDV) will be used to~     categorize thoughts and behaviors according to the SDVCS.~   "
157662|NCT01502423|"~     This study will compare injection site pain levels between current Humira® formulation versus~     a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either~     currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological~     naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The~     study is being conducted in three countries, Australia (3 sites), Canada (2 sites), and~     Germany (2 sites).~   "
157665|NCT01502384|"~     This is a longitudinal study in healthy 1st degree relatives of patients with Parkinson's~     Disease (PD) carriers of a genetic mutation in genes that are known to increase the risk for~     PD. The purpose of this study is to explore the association between genetic mutations in the~     known genes and early preclinical symptoms such as motor, sensory, autonomic, behavioral and~     cognitive functions.~   "
157666|NCT01502371|"~     The primary objective of this study is to demonstrate the dose-related efficacy, by~     evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent~     predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of~     three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler~     (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive,~     with persistent asthma. The primary hypothesis of this study is that at least one dose of MF~     MDI BID increases lung function, defined as a significant increase in percent predicted FEV1,~     when compared to Placebo.~   "
157667|NCT01502358|"~     The purpose of this study is to determine whether a new investigational dengue vaccine is~     safe, well-tolerated, and to see if an immune response against dengue disease will be~     generated.~   "
157668|NCT01502345|"~     The purpose of this study is:~      • To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and~     pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device~      Secondary:~      • To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and~     pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when~     administered with the TDS-IM electroporation.~   "
157669|NCT01502332|"~     The purpose of this study was to evaluate prospectively the impact of two protective~     mechanical ventilation strategies, both using low tidal volume ventilation (6 mL/kg/ibw)~     after cardiac surgery. The study selected patients presenting signals of deficient gas~     exchange (PaO2/FIO2 < 250 at a PEEP [positive end expiratory pressure] of 5 cmH2O) in the~     immediate post-operative period. An aggressive alveolar recruitment protocol applying opening~     pressures of 45 cmH2O, followed by ventilation with PEEP = 13 cmH2O, was compared to the~     standard alveolar recruitment protocol of the institution, where an opening pressure of 20~     cmH2O in the airways is followed by ventilation with PEEP = 8 cmH2O. After a stabilizing~     period of four hours of controlled mechanical ventilation, the patients followed the routine~     weaning protocol and physiotherapy protocol of the institution.~   "
157670|NCT01502319|"~     The Consortium's overall mission can be summarized as follows; each function is developed~     with the goal of clear military relevance:~        1. Produce new scientific knowledge about suicidal behavior in the military that improves~          mental health outcomes for the investigators men and women in uniform.~        2. Use high quality research methods and analyses to address problems in policy and~          practice that have a direct impact on suicide-related and other mental health outcomes~          for military personnel.~        3. Disseminate Consortium knowledge, information, and findings through a variety of methods~          appropriate for decision makers, practitioners, and others who are accountable for~          ensuring the mental health of military personnel. This includes the rapid response~          function so that queries from decision makers and others to the Consortium are answered~          with speed and efficiency. Technical assistance and support for decision makers and~          others is an integral aspect of this Consortium function. This aspect of the Consortium~          will warehouse knowledge about suicidal behavior in general (e.g., from civilian and~          international sources as well as from military sources), so that military issues can be~          informed in a comprehensive manner.~        4. Train future leaders in military suicide research through experience within a~          multi-disciplinary setting for Ph.D. students and postdoctoral scholars interested in~          research questions on military suicide of both a basic and applied nature.~   "
157671|NCT01502306|"~     California Smokers' Helpline will conduct a randomized trial to evaluate 3 strategies of~     services and/or incentives on smoking cessation rates. This project has the following~     specific aims:~        1. To increase tobacco cessation among Medi-Cal beneficiaries who currently smoke, and to~          improve the management of diabetes and other chronic disease by means of tobacco~          cessation.~        2. Demonstrate that tobacco cessation benefits that are well promoted and barrier free and~          include modest incentives, are effective in reducing smoking prevalence, lowering~          Medi-Cal health care costs, and improving health outcomes for diabetes management in~          particular.~   "
157672|NCT01502293|"~     This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12~     DNA injection (pIL-12) with electroporation (EP) in malignant melanoma. Intratumoral pIL-12~     EP is a gene therapy approach to directly induce a pro-inflammatory response within a tumor~     to initiate and/or enhance anti-tumor immunity.~   "
157673|NCT01502280|"~     Gliomas are the most common primary brain tumor, yet remain a challenge to effectively treat.~     Mounting evidence suggests that survival improves with greater tumor removal, yet being able~     do a complete removal can be difficult due to the tumor's infiltrating nature.~     5-aminolevulinic acid (5-ALA) is a natural compound that, when patients take it by mouth 3~     hours before surgery, is selectively taken up by glioma cells and causes a red/pink~     fluorescence (glow) under a blue light that allows tumor margins to be seen during the course~     of surgery. While this compound is used as a standard-of-care agent in Europe, it remains~     under testing by the Food and Drug Administration (FDA). A recent clinical trial in Germany,~     however, has demonstrated a significant improvement in the rate of complete resection for~     certain brain tumors (65% vs. 34%).~      The Barrow 5-ALA Intraoperative Confocal (BALANCE) Trial will measure the effect of 5-ALA on~     the amount of glioma tumor removal. To improve the usefulness of 5-ALA, a new special~     microscope fitted with a blue light, will be used to magnify microscopic fluorescence at the~     tumor margins. The investigators' hypothesis is that 5-ALA fluorescence with the use of the~     special microscope during surgery will greatly lower the amount of tumor left behind.~   "
157674|NCT01502267|"~     The purpose of this study is to determine whether high dose IVIG and B cell depleting agents~     can be used effectively in highly sensitized wait-listed patients.~   "
157675|NCT01502254|"~     The purpose of this study is to test if cancer patients who are informed about, and offered~     participation in a cancer clinical trial, are more knowledgeable about cancer clinical trials~     if they have access to an audio recording of their information visit.~   "
198580|NCT00963690|"~     The purpose of this study is to evaluate the safety and efficacy of the CloSys Hemostatic~     Device designed to stop bleeding after an interventional procedure.~   "
157676|NCT01502241|"~     The study aims to optimize the treatment of elderly subjects (> 65) with anaplastic~     astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative.~     There is no consensus as to how radical the surgery should be. Involved-field radiotherapy is~     the treatment most likely to be accepted apart from supportive and palliative measures. The~     role of chemotherapy is barely defined. Study data available to date does not suggest that~     this patient population would benefit from combined radiochemotherapy. The aim of the study~     is to verify the hypothesis that first-line chemotherapy with one week on/one week off~     temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of~     anaplastic astrocytoma and glioblastoma in the elderly (> 65 age group). The primary endpoint~     is median survival, as life expectancy is limited to several months. Secondary endpoints are~     response rates in both arms (CR, PR, MacDonald et al. 1990), median progression-free~     survival, 1-year and 2-year survival rates, definition of MGMT as molecular genetic~     prognostic or predictive markers, and quality of life. Theoretically, it should be possible~     to preserve quality of life in the first-line chemotherapy arm of the study.~   "
157677|NCT01502228|"~     Given the growing importance of anti-angiogenic therapies in the treatment of metastatic~     renal carcinoma, it is expected that this trial will establish the preliminary data needed to~     apply for funding of a larger clinical investigation of the potential role of PET perfusion~     imaging in management of renal carcinoma, and potentially other cancers.~   "
157678|NCT01502215|"~     Blood transfusion during perioperative period in patients undergoing to major surgery has~     been associated to several postoperative complications. Particularly in oncologic surgery,~     red blood cell transfusion has been investigated as a factor of worse outcome and cancer~     recurrence due to postoperative impairment of cellular immunity. Although red blood cell~     transfusion has decreased in worldwide clinical practice, this issue still remains a matter~     of controversy in oncologic surgery. There are no prospective studies comparing outcomes~     between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study~     is a prospective and randomized study comparing clinical outcomes between two strategies of~     transfusion in oncologic surgery - liberal or restrictive~   "
157679|NCT01502202|"~     Intercalated administration of Iressa® (gefitinib) on days 5-18 of chemotherapy cycle improve~     the efficacy of Pemetrexed/platinum regimen given as first-line treatment for never-smokers~     with advanced (stage IIIB/IV) lung adenocarcinoma.~   "
157680|NCT01502189|"~     The aim of this study is to explore whether an intensified informational intervention built~     upon the Representational approach framework can reduce stress in parents of children with~     cancer.~   "
157681|NCT01502176|"~     Retrospective observational study of patients with atrial fibrillation admitted to Roskilde~     University Hospital in 2010.~   "
157682|NCT01502163|"~     Although several measures for prevention of perioperative hypothermia have been introduced~     the last decades, perioperative hypothermia is still a frequent complication and associated~     with a negative outcome.~      For not long lasting surgery without specific risk for hypothermia the standard procedure for~     prevention of perioperative hypothermia is insulation. However, the insulation is often not~     effective enough to prevent intra- and postoperative hypothermia. The implementation of a~     prewarming is difficult because of variable OR schedules and therefore not often applied.~      In the planed prospective, multicenter, randomised-controlled trial will the efficacy of a~     convective prewarming system on prevention of intra- and perioperative hypothermia~     (Thermoflect™, TSCI, Amersfoort, NL) be compared to an intraoperative application of forced~     air warming with or without passive insulation before induction of anesthesia.~      The studied prewarming device is easy to use and will be applied on the nursery ward 30-60~     minutes before transfer of the patient to the OR.~      Perioperative hypothermia is a common complication in general aesthesia. Perioperative~     hypothermia is associated with medical risks as intraoperative impaired coagulation due to~     reversible platelet dysfunction, a prolonged bleeding time and increased intraoperative blood~     loss. In the postoperative course the perioperative hypothermia is especially for patients~     with cardiopulmonary diseases a relevant problem. Not at least sensual cold and shivering is~     uncomfortable for the patient.~      The study is conducted as a multicenter, prospective, randomised controlled trial. All~     patients will receive intraoperatively a forced air warming device (Termoflect™/Mistral Air~     ™). For one intervention group will additionally the insulation with the Thermoflect™ will be~     applied on nursery ward, the second intervention group will receive additionally a convective~     air warmer/ reflective blanket (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)~     preoperatively on study day on nursery ward.~      The aim of the study is to prove the hypothesis that a preoperative insulation with a~     commercial insulation material (Thermoflect™, TSCI, Amersfoort, NL) leads to a lower~     incidence of perioperative hypothermia in general anesthesia. The second hypothesis is, that~     an active prewarming (Thermoflect™ with Mistral Air™, TSCI, Amersfoort, NL) is associated~     with a more less incidence of periopative hypothermia.~   "
157683|NCT01502150|"~     The goal of this research study is to collect information on the side effects of proton~     therapy and the details of proton treatment plans so that researchers can develop a method to~     predict the risk of side effects and to improve the planning and delivery of proton treatment~     for patients in the future.~   "
157684|NCT01502137|"~     This trial is conducted in Europe. The aim of this trial is to to compare steady-state total~     growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy~     subjects.~   "
157685|NCT01502124|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin®~     cartridges (liquid somatropin) in children with growth hormone deficiency.~   "
157686|NCT01502111|"~     An international airway management expert group has recently developed an Utstein-style~     template for uniform reporting of data from prehospital advanced airway management.~     Implementing and validating the template will result in a high quality dataset and allow for~     research cooperation and comparison of airway management practice between EMS systems, and~     across different patient populations. Such a dataset will hopefully contribute to new~     knowledge in the field of prehospital advanced airway management.~   "
157687|NCT01502098|"~     The study aims to establish whether one month postoperative immobilization compared early~     passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double~     row technique has any healing significance.~   "
157688|NCT01502085|"~     Phase IIb clinical trial to determine if resistance to a lenalidomide containing regimen can~     be overcome by the addition of vorinostat, in patients with relapsed and refractory multiple~     myeloma.~   "
157689|NCT01502072|"~     The goal of this clinical research study is to learn if ribavirin can help to control RSV in~     patients with immune systems that have been weakened by a stem cell transplant. Researchers~     also want to compare the effectiveness of the drug when it is given by mouth to when it is~     inhaled. The safety of the drug in both methods of delivery will be studied.~      Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.~   "
157690|NCT01502059|"~     This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of~     Pilates to treat low back pain.~      Hypothesis - the Pilates group will have best results than the control group (usual~     medicament treatment).~   "
178036|NCT01234688|"~     The investigators raised the hypothesis that exercise training would be associated with~     improvement in exercise tolerance and VO2 kinetics in hemodialysis patients.~   "
157691|NCT01502046|"~     Huntington's disease (HD) is a progressive neurodegenerative disorder, related to an abnormal~     expansion of CAG triplets in the huntingtin gene, characterized by motor, cognitive and~     behavioral abnormalities, without known effective symptomatic treatment and without known~     disease slowing strategy. The most severe neuropathological lesions observed in HD take place~     in the striatum, one brain area important in motor control and rich in cannabinoid receptors~     (CBR). CBR are subdivided in two classes: CB1R are located in neurons and play a role in~     neuronal function; CB2R in brain are located mostly in microglia and modulate~     neuroinflammation.~      CBR disappear early in the course of HD, before there is a massive drop out of cells in the~     striatum. Cannabinoid transmission is also an early event in brains of animal models of HD.~     In R6/2 mice, which carry large CAG expansions and develop an early and severe HD phenotype~     the suppression of the CB1R gene further accelerate the development of a severe clinical~     syndrome and the characteristic brain inclusions and abnormalities of synaptic density. R6/2~     treated mice treated with cannabinoids improve their clinical phenotype, their brain lesions,~     the synaptic density and the levels of BNDF, a neurotrophic factor which enhances survival~     and resistance of striatal neurons.~      Preliminary studies of cannabinoids in patients with HD have shown that these compounds are~     safe in these patients. Those studies, however, did not show efficacy because 1) they were~     underpowered from the statistical point of view, 2) were performed with isolated pure~     cannabinoids, instead of the more physiological stimulation with a mixture of compounds, and~     3) they did use insensitive clinical parameters instead of sensitive end points, such as~     pathogenically important biomarkers.~      The investigators propose a phase II trial with combination of cannabinoids with evaluation~     of safety, by the profile of adverse events, and efficacy, according to changes of important~     biomarkers~   "
157692|NCT01502033|"~     This research study aims to test the safety and effectiveness of repetitive transcranial~     magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how~     rTMS treatment affects the neurobiology of teens with depression.~   "
157693|NCT01502020|"~     Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic~     keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week~     treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod~     cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of~     clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding~     scalp.~      The current clinical study is designed to evaluate the therapeutic equivalence of this~     formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation~     (Graceway Pharmaceuticals LLC).~   "
157694|NCT01502007|"~     The goal of the study is to determine if a Fitbit, a kind of accelerometer, provides feedback~     to subjects combined with an activity counseling program will result in an increase in~     physical activity of at least 20%.~   "
157695|NCT01501994|"~     The purpose of the study is to determine if providing physicians with a walking workstation,~     exercise counseling, and accelerometer feedback about activity will increase physician~     activity.~   "
157696|NCT01501981|"~     In this pilot, investigator-initiated multi-centre, multinational, observational study the~     investigators would like to examine the impact of therapy optimization on the level of~     biomarkers in patients with acute decompensated and decompensated chronic heart failure.~      The primary objective is to determine the best time point for measuring biomarker levels~     during therapy optimization in patients with decompensation to predict clinical outcomes such~     as mortality, hospitalisation, and quality of life.~      Secondary objectives are:~        1. To evaluate the impact of guideline-recommended medication on biomarker levels during~          and following recompensation.~        2. To evaluate whether the trajectory of relevant biomarkers (MR-proANP, MR-proADM) is of~          relevance to guide medical therapy following decompensation.~        3. To evaluate whether the degree of biomarker change (e.g. slow versus rapid change) is of~          relevance with regard to hemodynamic stability and cardiovascular events such as~          hospitalisation.~        4. To evaluate whether the trajectory of relevant biomarkers (copeptin, CT-pro-ET1) is of~          relevance to guide medical therapy following decompensation.~   "
157697|NCT01501968|"~     Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.~   "
157698|NCT01501955|"~     The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip~     Prosthesis (MHP) compared to the Stanmore hip replacement.~   "
157699|NCT01501942|"~     This is a Phase II, double-blind, placebo-controlled, cross-over trial to evaluate the~     efficacy of AIM-102 for the treatment of allergen-induced asthma. Individuals with stable,~     mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a~     history of episodic wheeze and shortness of breath, will be eligible for enrollment.~      The patients will receive 4 consecutive days of dosing of AIM-102 or placebo (inactive~     product) with an allergen challenge on day 3 of dosing to see how the patient's lung function~     is changed by using AIM-102 or placebo.~   "
157700|NCT01501929|"~     The purpose of this study is to determine if Nebivolol improves microvascular perfusion in~     skeletal muscle during exercise in hypertensive patients and whether this improvement is~     accompanied by reduction in vascular oxidative stress or increased endothelial nitric oxide~     synthase (eNOS) expression in humans.~   "
157701|NCT01501916|"~     The aim of this study is to investigate whether a supplementation of Vitamin D3 can be used~     to reduce atherosclerotic risk factors.~   "
157702|NCT01501903|"~     Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth~     in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of~     cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple~     attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of~     the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails~     to sample the cancer cells. The fanning technique is a method where the needle moves in~     multiple directions within a mass and therefore there is a better chance of the cancer cells~     being sampled compared to the standard technique where the needle moves in only one~     direction. The diagnostic performance of both these techniques has not been compared in a~     randomized fashion.~   "
157703|NCT01501890|"~     The purpose of this study is to investigate whether treatment with progesterone for patients~     with first trimester vaginal bleeding will alter the rates of obstetrical complications and~     adverse pregnancy outcomes.~   "
157704|NCT01501877|"~     This study is designed to develop and test a smoking cessation intervention for smokers with~     Type 2 diabetes.~   "
157705|NCT01501864|"~     The purpose of this study is to test whether school support can keep adolescent Kenyan~     orphans in school, reduce sexual risk behaviors, and prevent HIV /HSV-2 infection.~   "
157706|NCT01501851|"~     Prediction of Low Birth Weight Infants using Ultrasound Measurement of Placental Diameter and~     Thickness~   "
157707|NCT01501838|"~     The purpose of this study is to create a registry of patients with Pulmonary Hypertension who~     received medical care in the Hospital Italiano of Buenos Aires.~   "
157708|NCT01501825|"~     The Multiway stimulator is a novel TMS stimulator with several new and unique properties.~     Currently standard TMS devices include a single channel, and can operate only a single coil.~     The Multiway stimulator includes five channels which can operate up to five independent TMS~     coils, either simultaneously or sequentially.~      The Multiway device may be used to obtain a differential activation of various brain regions.~     For instance it can be used to induce high frequency stimulation of a certain brain region,~     thus inducing facilitation, while simultaneously stimulate at low frequency in another brain~     region, leading to inhibition.~      The purpose of the study is to explore the efficacy and safety of Multiway deep TMS in~     comparison to a single channel DTMS treatment in subjects with MDD.~      Subjects will be treated with one of two designs of the study device (the Multiway Coil TMS~     Device):~        1. Single Channel with a coil placed over the left PFC (10 Hz).~        2. Four channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. c. 10 Hz over the~          left parietal cortex. d. 1 Hz over the right parietal cortex.~   "
157709|NCT01501812|"~     Learning includes the ability to generalize to new situations and respond to similar, yet not~     identical stimuli. In previous work, focused on stimulus generalization in healthy~     volunteers, tones that were negatively reinforced induce wider generalization curves than~     tones that were positively reinforced, and these in turn induce wider curves than neutral~     memory (Schechtman et al, 2010).~      The current study aimed to evaluate those patterns in different clinical disorders (including~     Schizophrenia, Bipolar disorder, MDD, Anxiety disorders (Panic and GAD) and PTSD, and healthy~     subjects that would be used as a control), with consideration whether those patterns are~     unique to any specific disorder or state.~      The generalization patterns evaluation would conduct twice though enable to compare the~     stability of those patterns during the course of the illness (i.e during remission compared~     to acute state).~      The basic paradigm based on conditioning of a tone (sound) with unpleasant noise, and~     extinction of that conditioning afterword. During the 60 minutes of evaluation, the~     capability to discriminate between the original tone and similar but not identical tones, and~     the tendency to categorize similar tones as identical to the original tone. A neutral tone~     without conditioning will be used as reference. The clinical diagnosis will conduct by a~     senior psychiatrist, and the state would be evaluated using standard questionnaires~   "
157710|NCT01501799|"~     EPIDUO™ (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, marketed by GALDERMA LABORATORIES,~     L.P., is a safe and effective topical therapy used for the treatment of acne vulgaris.~     Actavis Mid-Atlantic LLC has developed a generic formulation of adapalene and benzoyl~     peroxide topical gel 0.1%/2.5%,and the current study is designed to evaluate the safety and~     efficacy of this formulation to determine if it is bioequivalent to EPIDUO™.~   "
157711|NCT01501786|"~     Normal cardiac and respiratory functions should be maintained during pediatric cardiac~     catheterization. Propofol has become a popular choice for sedation in children, however, it~     depresses cardiac and respiratory functions. Some investigators reported that ketamine~     attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and~     respiratory depression caused by propofol in pediatric cardiac catheterization.~   "
157712|NCT01501773|"~     A multi-centric initiative to study safety,feasibility and efficacy of using intravenous~     autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This~     phase of study is visualised as phase 2 study and will aim to determine dose response~     gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for~     autologous stem cell therapy in patient with acute ischamic stroke.~   "
157713|NCT01501760|"~     Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal~     opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to~     reduce newascularization induced by gastric cancer or age-related macular degeneration. A few~     reports have been published showing the interest of VEGF inhibitors to treat corneal~     newvessels, but no randomized study has been achieved to date.~      This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal~     antibody, to reduce the surface of corneal newvessels in when compared to placebo~   "
157714|NCT01501747|"~     The total effect of a medication is the sum of its drug effect, placebo effect (meaning~     response of placebo), and their interaction. Current interpretation of clinical trials (the~     gold standard of evidence-based-medicine) assumes no interaction, and the mechanism(s)~     underlying such interaction have not been fully explored. One possibility is that the placebo~     effect may modulate drug bioavailability. Using caffeine as a model drug, we have recently~     shown that the placebo effect of caffeine ingestion prolongs caffeine half life. Due to the~     novelty of this finding and its important clinical practice and clinical research~     implications, it needs to be confirmed in another set of subjects and extended to additional~     drugs.~      The results of the study are expected to further our understanding of the mechanism of action~     of a widely used medical intervention, i.e., placebo. The results will be important for both~     clinical practice and clinical research.~   "
157725|NCT01501604|"~     In people whos cancers have a PIK3CA mutation, this trial will be evaluating the drug BKM120~     as a possible treatment. BKM120 works by blocking the phosphatidylinositol-3-kinase~     (PI3K)pathway, thereby inhibiting tumor growth and survival.~      The purpose of this study is to learn if the study drug BKM120 can shrink or slow the growth~     of your tumor. The safety of BKM120 will also be studied. Your physical state, symptoms,~     change in the size of your tumor, and laboratory findings obtained while you are on study~     will help the research team decide if BKM120 is safe and effective in patients with advanced~     cancers.~   "
157726|NCT01501591|"~     The total effect of a medication is the sum of its drug effect, placebo effect (meaning~     response of placebo), and their possible interaction. Current interpretation of the results~     of clinical trials (the gold standard in evidence based medicine) assumes no such~     interaction. Using a novel cross-over balanced placebo design and caffeine as a model drug,~     the investigators have recently shown that a negative interaction does exist; suggesting that~     the size of drug effect as currently measured by clinical trials may not be accurate. Due to~     the novelty of the findings and their important clinical practice and research implications,~     they need to be confirmed using another drug; and the size of drug effect measured using the~     novel design need to be directly compared to that measured using conventional clinical trial~     design. The results of the study are expected to further our understanding of a widely used~     medical intervention, i.e., placebo, and help assess the appropriateness of randomized~     clinical trials in determining the size of drug effect.~   "
157715|NCT01501734|"~     Successful treatment of pulmonary edema was first published in 1938 by A. L. Barach. Since~     then, this has been the accepted method of treating acute respiratory failure due to left~     heart failure and edema.~      The question was raised if pressure supported ventilation during sleep is used to eliminate~     sleep apneas, would it be useful also for improving congestive heart failure (CHF). Recent~     studies assessed the role of continuous positive airway pressure (CPAP) in patients with~     advanced CHF and found the treatment useful. A possible explanation for these results is that~     central sleep apnea frequently coexists with severe CHF and is not treated or suppressed by~     CPAP.~      The frequency of central sleep apnea increases with the severity of CHF and can be found in~     more than 30% of patients.~      A few recent studies showed the usefulness of bilevel positive airway pressure (BIPAP) or~     adaptive servo-ventilation (ASV). ASV led to improvement in ejection fraction as well as in 6~     min walking distance testing, and was associated with decreased BNP levels. In another study,~     bilevel PAP increased LVEF by 7.9%.~      The limitations of these studies are the small number of patients and that they were~     conducted on inpatients only. These factors make it difficult to include BIPAP in the~     guidelines for chronic heart failure therapy.~      Recently, two outpatient modalities have been introduced to diagnose sleep disordering~     breathing (SDB). However, no study has directly compared the results of both studies in~     patients with CHF. Moreover, no studies have assessed improvement in CHF after BIPAP~     treatment.~      In addition, the investigators plan to assess the endothelial function in this population~     before and after BIPAP treatment with the EndoPAT, a noninvasive technology~   "
157716|NCT01501721|"~     Objective: This study aimed to characterize the food intake and energy expenditure of school~     cooks and to evaluate the anthropometric and metabolic changes that occurred after a~     low-volume home-based exercise program.~      Methods: A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was~     conducted during the school year of 2007. The trial had a factorial design based on two~     different interventions: 1) nutritional counseling and 2) home-based exercise. The~     nutritional intervention was focused on decreasing the amount of sugar used in school meals~     by the cooks as well as decreasing their own sugar intake. The exercise program consisted of~     stretching and aerobic exercises that could be practiced at home, at least three times per~     week (40 minutes per session), with a low-to-moderate intensity.~   "
157717|NCT01501708|"~     In this prospective phase II observational study, we plan to assess the efficacy and~     tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in~     a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched~     unrelated donor or mismatched donor conditioning with ATG containing regimen or present~     III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.~   "
157718|NCT01501695|"~     The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric~     patients with tic disorders.~   "
157719|NCT01501682|"~     The purpose of this study is to compare the long-term complaints after ventral hernia repair~     after insertion of different types of mesh compared with primary suture. Also recurrence of~     hernia will be discussed.~   "
157720|NCT01501669|"~     This study is a multicenter, randomized study, open-label, phase III study.The efficacy of~     irinotecan and capecitabine combination will be superior to capecitabine alone in term of~     progression free survival in metastatic breast cancer patients previously treated with~     anthracycline and taxane.~   "
157721|NCT01501656|"~     Promoter region hypermethylation of tumor suppressor genes is one the earliest molecular~     events in malignant transformation and is readily detectable in apparently normal benign~     breast epithelium adjacent to breast cancers. The investigators hypothesize that DNA~     methylation of certain genes occurs as a field change in benign breast tissue that is at high~     risk for malignant transformation, and as such, can be exploited for tissue-based breast~     cancer risk stratification. Additional work is required to identify new DNA methylation~     markers potentially useful for periareolar fine needle aspiration (RP-FNA)-based breast~     cancer risk stratification, to determine whether these markers are methylated more frequently~     in benign samples from women who develop breast cancer, to determine whether assessment of~     these markers is reproducible, to determine whether tamoxifen reduces DNA methylation, and to~     better understand the pattern of DNA methylation in benign samples from unselected healthy~     control populations. Each of these objectives contributes to advancement of a clinically~     useful RP-FNA-based breast cancer risk stratification test.~      In addition, identification of genes that are preferentially methylated in estrogen receptor~     (ER) negative breast cancer will provide clues to the underlying biology responsible for this~     aggressive form of breast cancer. This knowledge may lead to the discovery of the causes of~     ER negative breast cancer, approaches for recognizing women at increased risk for this type~     of breast cancer, and approaches for reducing this risk.~      This study seeks to identify patterns of DNA methylation in benign breast epithelial cells~     associated with an increased risk for breast cancer with a focus on ER negative breast~     cancer.~   "
157722|NCT01501643|"~     Acute chest syndrome is a severe respiratory complication of sickle cell disease.~      The standard prevention of this dangerous complication is spirometry in wich patient is~     required to take deep breaths trough a little device several times a day. This treatment is~     compromised when pain in important or when the patient is asleep and cannot participate.~      The investigators hypothesised that non invasive ventilation in wich patient have no effort~     to take might be a better prevention than spirometry and may improve pain and quality of~     sleep.~      Children with vaso-occlusive crisis necessitating morphinic treatment will be randomly~     assigned with either spirometry or ventilation and the investigators will monitor for~     occurrence of acute chest syndrome, pain and quality of sleep.~   "
157723|NCT01501630|"~     Compare PET/CT and MRI for the early detection of bone metastases of prostate cancer:~     diagnostic performance and impact on the patient management.Determine the lowest cost~     strategy according to the precise clinical circumstances.~   "
157724|NCT01501617|"~     The purpose of this study is to evaluate the safety and efficacy in relation to dosing in the~     administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected~     intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia).~   "
157760|NCT01501149|"~     The purpose of this study is to evaluate the efficacy and safety of DDGP regiment~     (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer~     (NK)/T Cell Lymphoma.~   "
157727|NCT01501578|"~     This study is an observational and retrospective study of patients with pulmonary fibrosis~     associated or not with telomerase mutation.~      The purpose of this study is to describe in detail the cases with telomerase mutation in~     terms of features on CT scan, respiratory function and evolution, in comparison to control~     subjects with idiopathic pulmonary fibrosis and no telomerase mutation identified or family~     history.~   "
157728|NCT01501565|"~     The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12~     and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP)~     and patients under conventional analgesia. Also the opioid consumption is assessed.~   "
157729|NCT01501552|"~     The overall objective is to study if training and support, financial reimbursement and~     referral to an internet based brief intervention programme, singly or in combination, may~     increase implementation of evidence based methods of identification and brief intervention~     for excessive alcohol consumption in routine primary health care.~   "
157730|NCT01501539|"~     The primary objective of this study is to compare the incidence of postoperative~     hypergranulation tissue formation after gastrostomy tube placement among children randomized~     to one of three treatments, in addition to measuring tube dislodgements and rates of resource~     utilization for complications.~   "
157731|NCT01501526|"~     Herpes esophagitis presents a clinical diagnostic challenge. The investigators report the~     first case of herpes esophagitis presenting as vocal fold palsy in an immunocompetent host.~     The investigators case highlights the importance of performing a detailed laryngoscopic~     examination in any patient with prolonged husky voice.~   "
157732|NCT01501513|"~     The objective of this study is to compare the safety, tolerance and efficacy of BLI800~     (approved and investigational regimens) to an approved control preparation as bowel~     preparations prior to colonoscopy in adult patients, particularly including the elderly and~     those with renal and/or hepatic impairment.~   "
157733|NCT01501500|"~     The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A~     (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by~     binding presynaptically to high-affinity recognition sites on the cholinergic nerve terminals~     and decrease the release of acetylcholine, causing a neuromuscular blocking effect. The~     investigators hypothesize that BTA injection may help to decrease the hallux valgus angle by~     decrease adductor hallucis muscle activation. Thereby enhance the therapeutic result of~     hallux valgus treated with total contact insole. The outcome measurement may shed light in~     treating patient with painful hallux valgus and document evidence for plantar pressure~     changes in acute, sub-acute and chronic stage.~   "
157734|NCT01501487|"~     Genomics assays that measure specific gene expression patterns in a patient's primary tumor~     have become important prognostic tools for breast cancer patients. This study is designed to~     test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and~     TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict~     responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer~     (LABC).~   "
157735|NCT01501474|"~     Utility of CholangioFlex and Fluorescent in situ Hybridization in the Diagnosis of Malignant~     Biliary Strictures~      Objectives~        1. To assess the sensitivity, specificity and accuracy of CholangioFlex in malignant~          biliary stricture diagnosis~        2. To assess the sensitivity, specificity and accuracy of Fluorescent in situ~          Hybridization(FISH) in malignant biliary stricture diagnosis~      Study design One academic center, prospective, diagnostic study~      Research Methodology Target population: Patients who are diagnosed malignant biliary~     stricture. Sample population: Patients who are diagnosed malignant biliary stricture in~     Chulalongkorn Hospital~   "
157736|NCT01501461|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the health of patients with human frailty syndrome.~   "
157737|NCT01501448|"~     The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF~     cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to~     equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as~     good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation~     of IVF cycles.~   "
157738|NCT01501435|"~     To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra~   "
157739|NCT01501422|"~     1. Sex hormone including estrogen have synergistic effect to serotonin activity and~          decrease activity of monoamine oxidase activity so the norepinephrine is not be~          metabolized, these substance are important to regulate hemostasis and circadian process~          of sleep~        2. Estrogen also regulate gamma-aminobutyric acid (GABA) secretion~             -  GABA substance is in order to initiate sleep and continue sleep~        3. According to epidemiologic data, problem of sleep was increasing in postmenopause group~          compare to premenopause group (aged-match)~        4. This research perform to find out the actual effect of estrogen in improving sleep~          quality.~   "
157740|NCT01501409|"~     Sodium lauryl sulfate (SLS) is an anionic detergent that has been used as the major or sole~     surfactant in most dentifrices. But it is known to local irritating factor to oral mucosa and~     skin and results in many side effects. This study was to compare the effects of SLS-free~     dentifrice and SLS-containing dentifrice in patients with recurrent aphthous stomatitis~     (RAS).~   "
157741|NCT01501396|"~     This randomized phase II trial studies the safety and efficacy of megestrol acetate given~     with or without mirtazapine in treating cancer patients with weight loss and loss of~     appetite. To date, no pharmacologic interventions have been approved by FDA to treat cancer~     anorexia-cachexia syndrome (CACS). Megestrol acetate has been shown to increase appetite in~     cancer patients. Adding mirtazapine may provide a much more effective treatment and help~     improve quality of life.~   "
157742|NCT01501383|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of VX-765 in~     subjects with treatment-resistant partial epilepsy.~   "
157743|NCT01501370|"~     Histone deacetylase (HDAC) inhibitors represent a potential new class of antitumor agents.~     Vorinostat (suberoylanilide Hydroxamic acid, SAHA) inhibits the activity of all 11 known~     human class I and II HDACs. HDACs have many protein targets whose structure and function are~     altered by acetylation, including histones and non-histones proteins component of~     transcription factors controlling gene expression and proteins that regulate cell~     proliferation, migration and death (1). Vorinostat has undergone initial evaluation in~     several phase I and II clinical trials in both solid and hematologic malignancies. It has~     shown activity in hematologic malignancies including Hodgkin's disease and non Hodgkin's~     lymphomas (2-5); it has been approved for treatment of cutaneous manifestation in patients~     with primary cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease~     on or following two systemic therapies (6). HDAC function is critical for Multiple Myeloma~     (MM) cells by actively maintaining a transcriptional program indispensable for their~     uncontrolled proliferation and/or inappropriate resistance to pro-apoptotic stimuli. The~     pleiotropic anti-MM effects of Vorinostat and its ability to sensitize MM cellsto multiple~     conventional or novel agents (7) provide the framework for clinical trials of Vorinostat in~     MM. A phase I trial of oral Vorinostat alone in advanced MM shows modest activity, but~     treatment was generally well tolerated (common drug related adverse events (AEs) included~     fatigue, anorexia, dehydration, diarrhea and nausea and were mostly grade < 2) (8). A phase I~     clinical trial of Vorinostat in association with Bortezomib in relapsed MM patients report a~     partial response (PR) rate of 42%, with responses occurring also in patients refractory to a~     previous Bortezomib based regimen. Treatment was generally well tolerated (main adverse~     events were myelosuppression, fatigue and diarrhea) (9). Lenalidomide is an active agent~     against MM, that as shown activity in both the relapse and newly diagnosed settings, in~     combination with chemotherapy or steroids only. The dose of Lenalidomide commonly used in the~     relapse setting, in association with steroids, is 25 mg/day on days 1-21 every 28 days (10,~     11). A recent phase I study evaluated the safety and tolerability of Vorinostat in~     combination with Lenalidomide and Dexamethasone in relapsed patients:no dose limiting~     toxicities prohibited dose escalation, the maximum tolerated dose has not been reached and~     the maximum administered dose was Lenalidomide 25 mg/day on days 1-21, Dexamethasone 40~     mg/day on days 1,8,15,22, Vorinostat 400 mg/day on days 1-7 and 15-21; each cycle was~     repeated every 28 days. Rate of at least PR was 51%, and activity was seen also in patients~     who received prior Lenalidomide therapy (clinical benefit reported in 69% of patients,~     including minimal response or better in 33% of Lenalidomide refractory patients). The most~     common drug related grade > 3 AEs were neutropenia, thrombocytopenia, diarrhea, anemia and~     fatigue (12). Since Vorinostat has shown efficacy also in patients previously treated with~     Lenalidomide, and in patients refractory to Lenalidomide, the investigators hypothesis is~     that the addition of Vorinostat and low-dose dexamethasone to Lenalidomide (ZLd), in patients~     experiencing a biochemical relapse during a Lenalidomide maintenance ongoing therapy, can~     overcome Lenalidomide-drug resistance and result in a significant response rate, that can~     translate into a significant improvement in survival of MM patients. The second hypothesis is~     that, since the dose of Lenalidomide commonly administered in maintenance therapy, is 10 mg~     days 1-21 every 28 days, the increase in Lenalidomide dose to the standard dose used for~     relapsing patients, plus low-dose Dexamethasone (Ld), in patients experiencing a biochemical~     relapse during a Lenalidomide ongoing maintenance, can as well overcome Lenalidomide-drug~     resistance and determine a significant response rate, that can translate into a significant~     improvement in survival of MM patients.~      This is a multicenter non comparative, randomized, open label, phase II study. Patients, who~     are receiving Lenalidomide maintenance treatment with or without prednisone, will be~     randomized to receive:~      Cohort 1: ZLd association:~      Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Vorinostat orally at~     the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle.~      Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.~      Cohort 2: Ld association:~      Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Dexamethasone orally~     at the dose of 40 mg day 1,8, 15, 22 every 28 days.~      Patients must have a -confirmed diagnosis of relapsed multiple myeloma. In this Phase II~     study, a total of up to 35 patients in the ZLd cohort and 48 in the Ld cohort will be~     enrolled. It is anticipated that full accrual to this study will take approximately 36~     months.~   "
157744|NCT01501357|"~     The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique~     compared with anteroposterior and biofilm removal and control of caries lesions in first~     permanent molars.~   "
178368|NCT01230294|"~     Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and~     strain-echocardiography) for measurement of the right ventricular (RV) function .~   "
157745|NCT01501344|"~     This study will determine if daily oral intake of 200g of a marketed yogurt with fortified~     calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in~     postmenopausal women. The efficacy of the product is measured by examining the variation of~     biochemical markers of bone turnover. MBP 80 is a particular protein contained in milk; it~     has been added to the yogurt provided for this study. The effects of MBP 80 on the quality of~     bone tissue have not yet been proven.~   "
157746|NCT01501331|"~     The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT)~     on a daily basis and transmission of data via the Remote Monitoring technology. This may~     result in early detection of imminent decompensation at a presymptomatic stage. The study~     will assess the respiratory trends correlation with clinically relevant heart failure events.~   "
157747|NCT01501318|"~     The investigators seek to develop a more efficient and effective approach to providing brief~     behavioral health interventions for risky substance use behaviors by comparing a brief coach~     directed intervention to a tailored report only group.~   "
157748|NCT01501305|"~     Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment~     in children.~   "
157749|NCT01501292|"~     Cytoplasmatic maturation is an important event in the general maturation of of the oocyte.~     Mitochondria is one of the major organelles involved in the process of cytoplasmatic~     maturation. The aim of this study is to investigate the presence and distribution of the~     mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine in-vitro~     maturation cycle with intracytoplasmatic sperm injection (ICSI). These oocytes will not~     undergo ICSI because of their immaturity. Usually, they are discarded. In addition to these~     immature oocytes the investigators shall also investigate the mitochondria in mature oocytes~     that underwent ICSI but did not become fertilized and are discarded.~   "
157750|NCT01501279|"~     The pudendal nerve conveys sensory, motor, sympathetic fibres to the perineum, bladder neck~     and proximal urethra. Pain management during transurethral procedures is a major~     concern.Patients who have been catheterized under anesthesia complained of urgency in the~     postoperative period because of catheter-related bladder irritation. We want to investigate~     that the effect of pudendal block to postoperative pain, bladder spasm and patient comfort in~     transurethral prostatectomies~   "
157751|NCT01501266|"~     The purpose of this study is to confirm the safety profile such as the frequency of serious~     adverse events or any unexpected adverse events and overall efficacy of Faslodex for long~     term treatment in daily clinical practice.~   "
157752|NCT01501253|"~     The aim of present study is to evaluate the efficacy and safety of two dose combination of~     S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy~     (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.~   "
157753|NCT01501240|"~     A prospective intra-individual study to investigate the diagnostic performance of gadoxetic~     acid-enhanced MR for the patients with liver cirrhosis using thin-section whole-explant as~     standard of reference~   "
157754|NCT01501227|"~     Ventilator associated pneumonia ( VAP) adds burden to the care of the intensive care patients~     as they may cause the death of the patient or prolong the intensive care stay or complicate~     the illness in other ways. The risk of infection is dependent on the interplay between~     bacteria load into the lungs and the immune status. There has been a lot of focus on bacteria~     load reduction and this includes the use of subglottic suctioning in an attempt to reduce the~     amount of bacteria that may move into the lungs. The Hi Lo tubes which were designed to allow~     subglottic suctioning was significantly effective in reducing the incidence of ventilator~     associated pneumonia compared to normal tubes. A new generation of endotracheal tubes that~     not only incorporate subglottic suctioning but provide a more snug fit into the tracheal by a~     new tapering design may be even more useful to provide the solution for bacterial load~     reduction. Conventional tubes which may furrow on themselves to allow the creation of~     microchannels may aid microaspiration. The taper guard which has facilities for subglottic~     suctioning as well as the strategy to reduce furrowing to the minimum may be the answer to~     the problem of ventilator associated pneumonia. This study is to determine the extent of~     protection this tube has against ventilator associated pneumonia compared with conventional~     endotracheal tubes~   "
157755|NCT01501214|"~     The hypothesis of this randomized double blind study is that the live birth rates are~     significantly higher after the use of atosiban prior to the embryo transfer in patients~     undergoing in vitro fertilization (IVF) treatment. This study aims to compare the live birth~     rates of IVF treatment between patients receiving atosiban and placebo prior to the transfer.~   "
157756|NCT01501201|"~     The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized~     medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of~     mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost~     utility of these two strategies.~   "
157757|NCT01501188|"~     The purpose of this study is to analyze the effects of Kinesio Taping on gastrocnemius muscle~     activation during gait and on Range of ankle motion in postmenopausal females with Chronic~     Venous Insufficiency in initial stages in comparison to a placebo control group.~   "
157758|NCT01501175|"~     To date, the investigators still do not know the annual incidence of Superficial Vein~     Thrombosis in the legs, although the investigators do know that this pathology is frequent~     and the investigators can assume its incidence is greater than Deep Vein Thrombosis which is~     of 1 to 2 cases per year per 1,000 inhabitants. Furthermore, the high percentage of SVT with~     concomitant DVT and Pulmonary Embolism only concerns patients seen in vascular medicine, so~     it is important to re-evaluate this rate on an unselected population from general practice.~   "
157759|NCT01501162|"~     Background/Aims:~      The investigators explored the therapeutic effects of probiotics in patients with AH.~      Methods:~      Between September 2010 and April 2012, the investigators conducted a 7-day,~     double-controlled, randomized, prospective clinical trial comparing the efficacy of~     probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an~     aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT)~     level with an alcohol consumption history within 48 hours. Patients were randomized to~     receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified~     Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and~     again after therapy.~   "
157762|NCT01501123|"~     PREHOSPITAL AGITATION AND SEDATION TRIAL (PHAST)~        -  The goal of the PHAST is to demine whether haloperidol is superior to midazolam for the~          sedation of agitated patients in the prehospital environment~        -  The primary outcome is the time to a Richmond Agitation and Sedation Scale (RASS) ≤1~           o The RASS is a well validated standardized score to measure a patient's agitation~        -  The secondary outcomes are~             -  Time until RASS returns to 0 or 1 if RASS <0~             -  Need for additional sedation~             -  Adverse effects (need for intubation, arrhythmia)~        -  Mercy EMS will be the only EMS agency in the Commonwealth of Pennsylvania carrying~          haloperidol~        -  Identification of potential study patients will be per state protocols~        -  Exclusion Criteria for the study~        -  Age <18~        -  Pregnant~        -  Allergic to study medication~        -  Transport to hospital other than Mercy Fitzgerald Hospital~        -  Unable to reach medical command prior to giving medication~        -  When a paramedic identifies a possible study candidate, the paramedic will consult~          medical command to see if the patient is appropriate for the study~        -  If the medical command agrees the patient is appropriate for the study, patients will be~          randomized to~        -  Odd days: Haloperidol 5mg IM (age <65) or haloperidol 2.5 mg IM (age ≥65)~        -  Even days: Midazolam 0.05 mg IM to maximum of 5mg IM (age <65) or maximum of 2.5mg (age~          ≥65)~        -  The RASS will be documented by the prehospital providers every 5 minutes until arrival~          at the hospital~        -  Once the patient arrives at the ED, the RASS will be documented in PICIS® by the~          emergency department nurse at the time of triage and at a minimum of hourly until the~          RASS =0 or 1 for 2 consecutive hours~        -  Questions may be directed to Dr. Isenberg at disenberg@mercyhealth.org or at (267)~          205-6453~      Richmond Agitation Sedation Scale~      RASS RASS Description~        -  4 Combative, violent, danger to staff~        -  3 Pulls or removes tube(s) or catheters; aggressive~        -  2 Frequent non-purposeful movement~        -  1 Anxious, apprehensive, but not aggressive 0 Alert and calm~             -  1 Awakens to voice (eye opening/contact) >10 sec~             -  2 Light sedation, briefly awakens to voice (eye opening/contact) <10 sec~             -  3 Moderate sedation, movement or eye opening. No eye contact~             -  4 Deep sedation, no response to voice, but movement or eye opening to physical~               stimulation~             -  5 Unarousable, no response to voice or physical stimulation~   "
157763|NCT01501110|"~     The propose of this study is to determine whether N-acetylcysteine is effective in reversing~     the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.~   "
157764|NCT01501097|"~     The purpose of this study is to determine if early application of CRRT will result in an~     improvement of clinical outcomes of burn patients during the early phase of sepsis~   "
157765|NCT01501084|"~     Obesity is a major health problem in the US and many Western countries, with more than half~     of the population being overweight or obese. Yet, despite intense research efforts into the~     mechanisms underlying obesity and into the development of novel pharmacologic interventions,~     bariatric surgery, including gastric bypass surgery is the only successful treatment for~     severe obesity. Mimicking one of the effects of bariatric surgery, e.g. the increased~     secretion of glucagon-like peptide 1 (GLP-1) could be an effective strategy against obesity.~      Obese individuals may be more sensitive to the rewarding aspects of food and less responsive~     to signals from the gut about actual energy needs. Using functional MRI scanning the~     investigators plan to examine the effect of Exenatide (a GLP-1 analog known to reduce caloric~     intake and produce weight loss in both obese and lean individuals) on activity within brain~     regions/networks involved in reward/motivation and in regulation of energy requirements. The~     investigators expect the peptide to change the balance between desire to eat for pleasure and~     the need to eat to maintain homeostasis.~   "
157766|NCT01501071|"~     Gastro esophageal reflux is the most common benign disease of the esophagus and Laparoscopic~     Nissen fundoplication became the standard surgical treatment of this disease. Although being~     almost transient postoperative dysphagia is still a common complaint following this~     procedure. The aim of this study is to investigate the effect of inserting a soft structured~     and blunt mounted 39 F orogastric tube to postoperative dysphagia.~   "
157767|NCT01501058|"~     This study aims to develop a parent-assisted social skills training program for adolescents~     with autism spectrum disorder(ASD) and verify therapeutic effects of the program through~     case-control study.~        1. Both the case and the control of this study shall be a high-functioning group consisting~          of adolescents aged 11 to 18 years with ASD and an IQ of 80 or over. A total of 40~          adolescents will be recruited and divided into two groups of twenty. One will be the~          case group and the other will be the waitlist control group. Again, the case will be~          divided into two sub-groups of ten and carry out this new developed program for both~          parents and adolescents. That is, the program will be carried out two times in each of~          both groups. The waitlist control group will be allowed to receive personal outpatient~          treatment and general therapeutic intervention from community while waiting.~        2. Effects of the program will be measured both at the case and the control by using a~          scale which measures social interaction, quality of peer relationship, disposition of~          autism and social anxiety. Equal assessments for both the case and the control will be~          conducted right before the beginning of the program and right after the completion of~          the program and some of the survey will be retried in order to see mid- and long-term~          effects three months after the completion of the program.~   "
157768|NCT01501045|"~     While some indications of the neural circuits involved in the Conditioned Pain Modulation~     (CPM) process are now available, there is still need to clarify what parts of the brain are~     essential for this process, whether the spino-brainstem loop is largely sufficient to explain~     CPM or whether other cerebral and spinal regions such as frontal, somatosensory and other~     cortical regions contribute substantially. Whereas mere observation of correlation between~     these circuits while activated by brain imaging is still of considerable interest, direct~     experimental manipulations by repetitive transcranial magnetic stimulation (rTMS) could even~     establish insights into causal relationships.~   "
157769|NCT01501032|"~     The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas~     system)automated insulin management system using continuous glucose monitoring (CGM) and~     subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will~     include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus~     meal, under-bolus meal and exercise.~   "
157770|NCT01501019|"~     Exercise may improve physical capacity and health parameters in Primary Syndrome´s Sjogren,~     Myositis and Takayasu's Arteritis.~      Therefore, this study aims to investigate the role of an exercise training program in~     patients with Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.~   "
157771|NCT01501006|"~     The purpose of the study is to improve patient-physician communication and clinical decisions~     in the context of serious illness that may affect important clinical outcomes. The~     investigators will examine how variations in communication patterns and clinical decisions~     are affected by patient demographics (e.g age, sex), patient interactional style (e.g.~     communication behaviors) and physician characteristics (e.g. attitudes, background,~     training).~   "
157772|NCT01500993|"~     This study compares capecitabine with standard 5-FU in the perioperative treament of locally~     advanced rectal cancer.~   "
157773|NCT01500980|"~     The purpose of this study is to determine if sterile, protective immunity to malaria can be~     induced by malaria parasite exposure limited to the early liver stage of the parasite~     lifecycle.~   "
157774|NCT01500967|"~     Neck pain and related problems occur frequently in modern societies and have a considerable~     impact on individuals and the society. Cervical radiculopathy (CR) generally presents with~     pain, numbness, or weakness in a dermatomal distribution. CR results from impingement on a~     nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral~     disc herniation. Various studies have shown that nonoperative management for CR is effective,~     such as medications, physical therapy, Spinal manipulation, traction, acupuncture, collar~     immobilization and epidural steroid injections. Spinal manipulation is one of the manual~     techniques for treating mechanical neck pain. No high-quality evidence has proved the~     effectiveness of manipulative therapy in the treatment of cervical radiculopathy. However,~     limited evidence suggests that manipulation may provide short-term benefit in the treatment~     of neck pain, cervicogenic headaches and radicular symptoms. Few complications, such as~     worsening radiculopathy, myelopathy, and spinal cord injury, may occur. Spinal massage~     manipulation is used for centuries in China. Many patients with cervical disc disease are~     increasingly turning to manipulations to alleviate their symptoms and reduce the side effects~     of medications. The goal of this study is to determine the efficacy of a spinal manipulation,~     three steps and nine manipulations, on treating with the cervical radiculopathy.~   "
157775|NCT01500954|"~     MicroRNAs (miRNAs) are a novel class of short RNAs which have shown to be dysregulated in a~     variety of cancers. Data of miRNA expression in cutaneous squamous cell carcinoma (cSCC) is~     very limited and microarray based genome wide miRNA expression profiles of cSCC have not been~     investigated so far.~   "
157776|NCT01500941|"~     Probiotics are suggested to have beneficial effects in atopic dermatitis (AD) treatment and~     prevention but their precise role is not yet clear.~      The aim of this randomized double blinded active treatment vs placebo study was to evaluate~     clinical efficacy of intake of a combination of two probiotics (Lactobacillus salivarius LS01~     and Bifidobacterium breve BR03) for the treatment of adult AD patients.~      The rationale for the use of probiotics in the treatment of atopic dermatitis would be due to~     some experimental hypotheses:~        1. The use of these microbial agents at an early age seems to play an important role in~          inducing immunity T type 1 (Th1) and inhibit the development of a Th2 response IgE~          mediated~        2. the normal intestinal flora (including probiotics) would play an important role in~          inducing immunological tolerance~        3. the hygiene hypothesis that the reduced bacterial environment would favour a type 2~          response T and the development of allergic diseases~   "
157777|NCT01500928|"~     The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0)~     micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for~     their treatment.~   "
157778|NCT01500915|"~     The purpose of this study is to investigate the safety and efficacy of a combined~     fixed-interval and a pro re nata (PRN) regimens of ranibizumab (FUSION regimen) for the~     treatment of exudative age-related macular degeneration (AMD) in patients with good visual~     acuity (VA) at baseline. To establish whether similar efficacy to monthly regimens can be~     achieved with fewer injections, even in patients with good VA.~   "
157779|NCT01500902|"~     The purpose of this study is to determine if testing patients for endothelial dysfunction~     will help identify which patients are more likely at risk to have another heart attack in the~     future. Study participants will undergo mental stress testing while at the same time being~     connected to a device that measures endothelial function via the Endopat device. These same~     participants will also undergo a sleep study via the Watchpat device.~   "
157780|NCT01500889|"~     The investigators compared conventional lateral internal sphincterotomy (CLIS), V-Y anal~     flap, and combined tailored lateral internal sphincterotomy with V-Y anal flap (TLIS with~     V-YF) in a randomized prospective study in patients undergoing treatment for chronic anal~     fissure.~   "
157781|NCT01500876|"~     Eligible lung cancer patients: Undergo pre-treatment 4D-CT study for treatment planning~      External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation~     therapy~      Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment~      Primary objectives: To assess pre-treatment global and focal lung strain and correlate with~     changes post-treatment~   "
157782|NCT01500863|"~     Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in~     women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides~     adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS)~     still occurs in 1-3% of the patients. If gonadotropin-releasing hormone agonist (GnRHa) are~     used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.~      By testing different luteal support protocols on women undergoing GnRHa triggering, the~     investigators aim to find out which protocol resembles the most the gene expression profile~     observed after hCG triggering and conventional luteal phase support, in order to choose it as~     the most adequate in terms of endometrium receptivity and safety (OHSS incidence).~   "
157783|NCT01500850|"~     The aim of this study is to observe changes in cardiovascular biomarkers during treatment~     with Lantus in patients with Type 2 Diabetes mellitus.~   "
157811|NCT01500486|"~     This study is conducted in Europe. The aim of this study is to evaluate ease of injection of~     growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience~     and tolerability of NordiFlex PenMate™ - an automatic injection and a needle hiding device -~     is also evaluated.~   "
157812|NCT01500473|"~     Background: Congenital Central Hypoventilation Syndrome (CCHS) is a rare disorder of~     automatic control of breathing. This disease can manifest as early as birth. Patients with~     this disease have a fundamental lack of central drive breathing. They do not mount any~     responses to hypoxia or hypercapnia during sleep or wakefulness. This places them at risk of~     injury or death whenever they are not consciously breathing. They require lifelong assisted~     ventilation while sleeping, and some while awake. Progesterone is a known respiratory~     stimulant in normal individuals, and it has been shown in one study of 2 patients that this~     drug may improve CO2 responsiveness in patients with CCHS. However, this observation requires~     confirmation.~      Hypothesis: Exogenous progesterone (in oral contraception pills) will improve CO2~     responsivity by hyperoxic hypercapnic ventilatory response testing, hypoxic responsivity~     using 5-breath nitrogen breathing, hyperoxic ventilatory response while breathing 100%~     oxygen, and improve spontaneous ventilation during sleep in CCHS females >15-years of age.~     The progesterone will also depress ventilatory response using a hyperoxia test.~      Study Methodology: Baseline measures of CO2 and oxygen responsivity, and spontaneous~     ventilation during sleep, will be performed at baseline and after 3-weeks of taking a~     progesterone containing oral contraceptive agent. CO2 responsivity will be measured using a~     hyperoxic hypercapnic ventilatory response test. Hypoxic responsivity will be measured using~     a 5-breath 100% nitrogen breathing test. Hyperoxic responsivity will be measured by having~     subjects breathe 100% oxygen for 2-minutes. Subjects will perform an overnight polysomnogram~     to assess adequacy of gas exchange during spontaneous breathing while asleep. A progesterone~     containing oral contraception pill will then be given for 3-weeks, and the above measures~     repeated. Serum progesterone will be measured at baseline and at the time of study.~   "
157784|NCT01500837|"~     Background:~      One of the leading causes of peri-operative osteoarticular infections (OAI) is Staphylococcus~     aureus. Treatment usually requires surgical debridement in association with appropriate~     antibiotic therapy. After surgery, an intravenous (IV) antibiotic therapy is routinely~     indicated for 10 to 15 days, followed by a minimal one-month oral treatment. In this~     protocol, the latter includes clindamycin in combination with rifampin or levofloxacin.~     Clindamycin is considered a good option in staphylococcal infections, because of its action~     against biofilm formation and bacterial adherence, its high level of joint and bone~     penetration and its good tolerance. Rifampin, a potent cytochrome P-450 inducer, enhances the~     elimination of a large number of drugs. Therefore, an influence of rifampin on clindamycin~     pharmacokinetics must be considered.~      Objectives:~      The primary objective is to compare the influence of rifampin and levofloxacin respectively~     on the pharmacokinetics of clindamycin in a randomized series of peri-operative~     staphylococcal OAI. The investigators then seek to determine the optimal drug association~     with regard to infection control and drug tolerance.~      Study design:~      Monocentric, randomized, open label, comparative study~      Study period:~      From November 2010 to October 2011.~      Materials and Methods:~      Following surgical debridement and after 10 to 15 days of IV antibiotherapy, patients are~     randomly assigned either to the clindamycin/rifampin arm either to the~     clindamycin/levofloxacin arm, according to the antimicrobial susceptibility testing. Peak~     and trough serum concentrations of clindamycin are measured at day-1, day-15 and day-30 of~     oral treatment. Rifampin and levofloxacin serum concentrations are measured at the same~     intervals to monitor patient compliance.~   "
157785|NCT01500824|"~     This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East~     Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event~     involving the ALK gene locus who have received only one prior chemotherapy regimen for~     advanced NSCLC and this regimen must have been platinum-based. Primary objective of this~     study is to assess the anti-tumor activity and safety profile of crizotinib. Secondary~     objectives are to evaluate clinical efficacy including median progression-free survival (PFS)~     and 1-year PFS rate, overall survival (OS), disease control rate (DCR) at 6 and 12 weeks,~     time to response (TTR), and duration of response (DR).~   "
157786|NCT01500811|"~     Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and~     soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There~     are treatments available to help manage these symptoms like weight loss, and analgesics.~     Surgery is the appropriate treatment in patients who have failed these conservative~     treatments. The aim of this clinical study is to assess safety of autologous cultured~     chondrocyte intra-articular injection and obtain its clinical results in patients with severe~     hip osteoarthritis.~   "
157787|NCT01500798|"~     This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone~     methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less~     than 60.0 ml/min/1.73m2) and diabetes to ensure at least 15 patients complete the study for~     evaluation of the primary endpoints.~   "
157788|NCT01500785|"~     Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary~     artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial~     dysfunction. It has been suggested that the mechanism responsible for the contractile~     depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium.~     Levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned~     myocardium without obvious impairment of diastolic function. Systemic vasodilation and need~     of vasoconstrictive medication is usually apparent after administration of levosimendan.~     Colucci et al have demonstrated that with intracoronary administration of milrinone, another~     inodilator, systemic vasodilation could be excluded. If this is true with levosimendan, it~     may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by~     adding levosimendan into cardioplegia solution.~      The investigators hypotize that levosimendan, delivered together with cardioplegia, can~     improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic~     valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac~     output 15 min after separation from cardiopulmonary bypass compared to the baseline.~     Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal~     closure and cTnT/CK-MB on the first postoperative morning.~   "
157789|NCT01500772|"~     This study is to evaluate the overall efficacy, and safety profile of the triple combination~     therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV)~     patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease~     inhibitor (PI).~   "
157790|NCT01500759|"~     Objective target of the registry is to investigate the prevalence of SDB as well as the~     clinical characteristics of patients with and without SDB as well as the predominant type of~     sdb.~      For this purpose data from patients suffering from chronic, symptomatic heart failure with~     impaired left ventricular ejection fraction will be collected prospectively.~   "
157791|NCT01500746|"~     This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts~     in chronic wounds.~   "
157813|NCT01500447|"~     Background:~      - During puberty, children begin to develop into adults. Problems with the hormones released~     during puberty can affect the reproductive system. Some people have low hormone levels that~     severely delay or prevent puberty. Others start puberty abnormally early. Other people may~     have a normal puberty but develop reproductive disorders later in life. Researchers want to~     study people with reproductive disorders to learn more about how these disorders may be~     inherited.~      Objectives:~      - To learn how reproductive system disorders may be inherited.~      Eligibility:~        -  People with one of the following problems:~        -  Abnormally early puberty~        -  Abnormally late or no puberty~        -  Normal puberty with hormonal problems that develop later in life~        -  People who have not yet had puberty but have symptoms that indicate low hormone levels.~      Design:~        -  Participants will provide a blood sample for testing. They will complete a questionnaire~          about their symptoms. They will also have a scratch-and-sniff test to study any problems~          with their ability to smell.~        -  Participant medical records will be reviewed. Participants will also provide a family~          medical history.~        -  Family members of those in the study may be invited to participate.~        -  Treatment will not be provided as part of this study.~   "
157792|NCT01500733|"~     Background:~      - Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood or~     lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white blood~     cells that hurt the immune system and make it more difficult to fight infections. These~     cancers are usually diagnosed after age 50; more than half of the people with CLL/SLL are~     over age 70. Elderly people often do not respond well to standard chemotherapy for CLL/SLL.~     They may have other health problems that make chemotherapy difficult. In addition,~     individuals who have a genetic abnormality called 17p deletion also do not respond well to~     standard treatments for CLL/SLL. Researchers want to test a new cancer treatment drug,~     PCI-32765, to see if it can treat CLL/SLL in these hard-to-treat groups.~      Objectives:~      - To see if PCI-32765 is a safe and effective treatment for CLL/SLL in older people and~     people with 17p deletion.~      Eligibility:~        -  Individuals over 65 years of age who have CLL/SLL.~        -  Individuals at least 18 years of age who have CLL/SLL and 17p deletion.~      Design:~        -  Participants will be screened with a medical history, physical exam, and imaging~          studies. Blood and urine samples will be taken. Optional bone marrow and lymph node~          biopsies may also be taken.~        -  Participants will take PCI-32765 capsules every day for 28 days (one cycle of~          treatment). Treatment will be monitored with frequent blood tests and clinic visits.~        -  PCI-32765 will be given for six cycles of treatment. Those who benefit from the drug~          will continue to take it as long as there are no side effects and the disease does not~          progress. Those who do not benefit will stop treatment and have regular followup exams.~   "
157793|NCT01500720|"~     Primary Objective:~      To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to~     topotecan in participants with sensitive or resistant/refractory small cell lung cancer~     following a first line platinum based chemotherapy.~      Secondary Objectives:~        -  To assess disease progression free rate at 12 weeks~        -  To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and~          duration of response~        -  To assess Overall Survival (OS)~        -  To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC]~          version 4.03)~        -  To assess the Health-Related Quality of Life (HRQoL)~   "
157794|NCT01500707|"~     This study is being done to assess the pharmacokinetics of SCH 900800 in participants with~     moderate to severe Parkinson's Disease (PD) being treated with L-DOPA.~   "
157795|NCT01500694|"~     For subjects in Europe that have already participated in either Study SPD503-315 or~     SPD503-316. This is an extension study that will allow participants access to~     Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the~     sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl~     (SPD503).~   "
157796|NCT01500681|"~     Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is~     associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical~     relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly~     used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance~     PLEX) is sometimes used to prevent relapses. This observational registry will record~     feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX~     for NMO.~   "
157797|NCT01500668|"~     Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive~     drugs such as amines. Finger necrosis (so called blue toe syndrome) is a well documented~     phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum~     toxin is a known muscle relaxant used for a variety of medical application. Recently, several~     reports have demonstrated its effect in vasospastic disorders. It has also been in mice that~     when administered locally it has a local vasodilatory effect. The goal of this experiment is~     to compare the effect of Botulinum Toxin administered locally on amine induced finger~     necrosis.~   "
157798|NCT01500655|"~     The purpose of this study is to determine whether either a peripheral nerve block under~     ultrasound (u/s) guidance of the lateral femoral cutaneous nerve (LFCN), versus an u/s guided~     block of the nerve followed by continuous catheter infusion of local anesthetic, offers~     better post-operative analgesia in pediatric burn patients undergoing reconstructive surgery,~     than the current analgesic regimen of subcutaneous local anesthetic infiltration.~      Eligible subject, pediatric patients having reconstructive surgery for burns, having skin~     graft donor sites of the lateral thighs, will be randomized into three groups: control~     (having local infiltration of site), ultrasound guided nerve block, or ultrasound guided~     nerve block with catheter placement --fascia iliac.~      Post-operative comfort will be assessed over the next 48 hours.~   "
157799|NCT01500642|"~     The dose and the mode of administration of sublingual therapy remain open questions to~     determine the efficacy and safety of this desensitization therapy, the main purpose of this~     study is to evaluate if different routes of administration (oral-vestibular vs. sublingual)~     and a maximum dose of allergen administered are able to determine a different effect or a~     different incidence of side effects of the therapy in a group of patients with~     rhinoconjunctivitis and/or asthma due to ragweed~   "
157800|NCT01500629|"~     The purpose of this study is to see if a new nasal spray can reduce the signs and symptoms of~     allergic rhinitis (hayfever). Subjects' participation in the study will last approximately 4~     to 6 weeks, and each of three study visits during that time will last a few hours. Subjects~     will be required to have several tests done including allergy and breathing tests. They will~     be exposed to the item they are allergic to and will have small paper discs put in their~     noses. Subjects will also have the inside of their noses examined and will be asked questions~     about the level of their allergy symptoms.~   "
157801|NCT01500616|"~     The purpose of this study is to collect safety and tolerability data on telaprevir treatment~     in combination with Peg‑IFN‑alfa and RBV in patients with HIV/genotype 1 chronic HCV~     coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment~     into an ongoing clinical study of telaprevir.~   "
157814|NCT01500434|"~     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™~     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo~     atherosclerotic coronary artery lesions. The lesions can be longer than average-sized.~   "
158058|NCT01497223|"~     The primary objective of the study is to evaluate the rate of therapeutic cure of the~     combination treatment of MGCD290 and fluconazole as compared to that of fluconazole alone at~     Test of Cure Visit for patients with moderate to severe vulvovaginal candidiasis.~   "
157802|NCT01500603|"~     Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have~     been presented as efficient treatments for management of stress urinary incontinence (SUI)~     following radical prostatectomy (RP), but no comparative study of these two techniques has~     been published. The investigators aims were to compare the efficacy of the two devices and~     provide data about their cost effectiveness.~      Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is~     more efficacious than Pro-ACT balloons at one year follow-up.~      Primary objective: The primary objective of this study is to compare the efficacy of the~     AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after~     RP at one year follow-up.~      Secondary objectives:~        -  Comprehensive comparative medical evaluation of the two devices in terms of efficacy~        -  Complete evaluation of the side effects of the two techniques~        -  Evaluation of the quality of life~        -  Evaluation of patient satisfaction~        -  Cost-effectiveness study of the device (total cost over one year of each of the two~          techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential~          cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be~          made for assessing the potential coverage by the French healthcare system) Population:~          Patients with history of RP without cancer recurrence, presenting pure SUI on~          urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test~          < 300g).~      Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers),~     comparative trial of the two devices (with a superiority hypothesis). The total number of~     subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at~     1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated~     questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report~     of any secondary effect). Statistical evaluation is carried out at the end of the follow-up,~     in intent to treat.~      Medical evaluation:~      Main criterion:failure of the treatment, defined by reduction of less than 50% of~     incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical~     device for SUI.~      Secondary outcome criteria~        -  pad usage per day~        -  quantitative reduction of the 24hr-pad test~        -  complications (infection, erosion, hematoma, acute urinary retention)~        -  number of re-interventions or re-admissions during follow-up~        -  quality of life measured by the ICIQ-SF questionnaire~        -  patient satisfaction by the PGI-I questionnaire~      Economic evaluation:~        -  Study of the total cost over one year in each case~        -  Adjustment of cost of each device to quality of life (QALY evaluation)~        -  Cost effectiveness study~        -  Proposals will be made to state at which level the two devices should be covered by the~          healthcare system.~   "
157803|NCT01500590|"~     Diabetes is the leading cause of chronic kidney disease in developed countries. About 30-40%~     of patients with type 1 and type 2 diabetes mellitus will develop diabetic nephropathy.~     Microalbuminuria is often used as an early predictor of diabetic nephropathy. Many studies~     already demonstrated the renoprotective effect of Renin-angiotensin-system (RAS) blockers in~     patients with varying degree of albuminuria, few studies focus on studying the decline in~     glomerular filtration rate (GFR) among patients with normoalbuminuria. However a substantial~     number of diabetic patients exist with sub-normal GFR without microalbumin excretion. From~     literature, diabetes mellitus will have faster decline in GFR but the investigators do not~     know whether such decline can be slowed down by the use of RAS blockers as compared with~     other anti-hypertensive drugs. This Study investigate the effect of early treatment with RAS~     blockers on the decline rate of GFR in diabetic patients with normoalbuminuria.~   "
157804|NCT01500577|"~     The primary objective of the proposed trial is to assess. The efficacy and the safety of a~     daily administration of nimesulide or simvastatin to change the expression of a large set of~     tissue and circulating surrogate endpoint biomarkers (SEBs) of breast carcinogenesis in women~     at higher risk of developing a hormone non-responsive (ER neg) breast cancer. The primary~     endpoint is the change in prevalence of atypical cells and cellular proliferation (Ki-67),~     after 12 months of treatment.~   "
157805|NCT01500564|"~     Previous research that utilises single sessions of transcranial direct current stimulation~     (tDCS) have demonstrated functional improvements. However these improvements are usually~     short-lived, lasting less than one hour before the patient's performance returns to baseline.~     In these studies, tDCS is typically applied with the goal of adaptively enhancing functional~     activation of pathologically under-active tissue or suppressing pathologically over-active~     tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can~     improve learning/memory functions in healthy controls. The goal of this study is to test if~     the application of tDCS could enhance learning and/or memory for physiotherapy~     rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients~     at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions~     of tDCS.~      This research has important implications; previous studies suggest that such an approach has~     the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a~     clinically viable rehabilitative tool. Recovery of motor skills may take many months to~     acquire and therefore strategies that have the potential to enhance acquisition of skill are~     of practical and scientific interest.~   "
157806|NCT01500551|"~     Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have~     previously participated in tofacitinib JIA studies.~   "
157807|NCT01500538|"~     Vorinostat is a drug (Histone Deacetylase Inhibitor [HDACi]) administered orally that has~     been approved in United States for the patients with cutaneous Tcell lymphoma (CTCL) who have~     progressive, persistent or recurrent disease on or following two systemic therapies.~      In the early period of treatment with vorinostat, some patients may experience low platelet~     counts. Therefore this study will be examining the combination of these two medications~     (Vorinostat and eltrombopag) to assess if eltrombopag can overcome the low platelets during~     treatment with vorinostat.~      Eltrombopag is a drug administered orally designed to mimic the protein thrombopoietin, which~     causes the body to make more platelets. Eltrombopag has been registered in Australia and~     approved overseas to treat patients with chronic ITP (Immune Thrombocytopenia Purpura) a~     disease where patients destroy their own platelets very rapidly and thus develop low platelet~     count) but it is not registered and it is not yet known whether eltrombopag can increase~     platelet counts in patients treated with the HDACi.~      The aim of this project is to test whether Vorinostat and eltrombopag can be safely combined,~     and to test whether they are effective in participants with T-cell lymphoma involving the~     skin or patients with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma~     (MZL), or mantle cell lymphoma (MCL)~      A total of 25 people with Cutaneous T cell lymphoma/ CTCL, marginal zone lymphoma, follicular~     lymphoma or mantle cell lymphoma will be recruited in this study.~   "
157808|NCT01500525|"~     Objectives:~      Our goal is trying to identify an ideal BDR cutoff point for Chinese controller-naïve~     asthmatic children. In order to achieve this, several steps need to taken.~        1. To observe BDR distribution curve for Chinese non-asthmatic children from 4-12 years~        2. To observe BDR distribution curve for Chinese controller-naïve asthmatic children from~          4-12 years~        3. To compare BDR values between non-asthmatic group and controller-naïve asthmatic group,~          and analyze appropriate cut-off point value~      Hypothesis:~        1. Publications and our clinical experience indicate BDR value is affected by ethnicity,~          and children are less responded to bronchodilator compared with adult patients. From~          this aspect, data from Chinese children may be different from data included in the~          guidelines which mostly determined by studies in adults~        2. Reversible bronchospasm is a characteristic in asthma patients. Between asthmatics and~          non-asthmatics, different response to BDR test would be observed, and there would be a~          cutoff point with good sensitivity and specificity to differentiate asthmatics from~          non-asthmatics~      Background and rationale:~      According to the guideline of global initiative for asthma, global strategy for asthma~     management and prevention (GINA) and guideline of United States National Asthma Education and~     Prevention Program (NAEPP) guidelines spirometry, including baseline forced expiratory volume~     in 1 second (FEV1) and the bronchodilator response (BDR) to short acting beta agonists~     (SABA), should be used in children as objective measures to establish the diagnosis and~     severity of bronchial asthma. Spirometry is necessary because not every child came to the~     clinic with typical symptoms and the objective measurement can improve diagnosis confidence.~     Baseline FEV1, the so called gold standard for evaluating airway obstruction in adults, is~     usually in the normal range (greater than 80% predicted) in children, regardless of asthma~     severity. This substantially limits its value for diagnosis and assessment of response to~     treatment. Because of this, several other objective measures have been suggested for~     diagnosis and treatment in children, including the response to a bronchodilator, which~     reflects not only airway reversibility, but also a marker of airway inflammation.~      The current definition for a positive BDR is >12% reversibility and >200 ml increase from~     initial FEV1 after short acting beta-agonist (SABA) has been used. However, recent reports~     and our clinical observation revealed that, in a significant part of Chinese asthmatic~     children, their BDR value cannot achieve 12% in the evaluation.~      It has been suggested that the cutoff point of 12% is too conservative for pediatric~     patients. In the study carried out by Galant et al among 51 non-asthmatic children and 346~     controller naïve asthmatic children between 4-17 years, the BDR value could achieve 12% in~     only 30.6% asthmatic children, across all severity. Meanwhile, when observing BDR value in~     the above study, results were 2.2% (95% CI, 0.2-4.3) in the non-asthmatic group compared with~     8.6% (95% CI, 7.5-9.8) in the asthmatic group. The range seen was 7.6% (95% CI, 5.8-9.5) for~     mild asthma to 10.1% (95% CI, 7.6-12.6) in the severe persistent group. Also, in a study~     among 142 children between 5-10 years in UK, 9% increase in FEV1 after bronchodilator use was~     suggested as the cutoff point with good sensitivity and specificity. Moreover, in a study~     carried out among 3052 children in rural area between 8-15 years in Anhui Province in China,~     results showed BDR was 3 +/- 5% in non-asthmatic children, and 7 +/- 9% in asthmatic~     children.~      Difference between the proposed study to be carried out in our hospital and the one in Anhui~     Province is that subjects in this proposed study are from 4-12 years old, which is the~     largest patient segment in our clinic including preschool and school students. And most~     importantly, the main purpose of study in Anhui is to observe the BDR range of the~     non-asthmatic children and asthmatic children, while in our study, besides this objective,our~     will tentatively calculate a BDR cutoff point by using receiver operating characteristic (ROC~     curve). And the cutoff point can be used as a reference indicator in asthma diagnosis and~     long-term management.~      The current BDR cutoff point of 12% that is not ideal for children can also be reflected in~     the clinical management. It has been shown that a persistent BDR value, even less than 12%,~     in asthmatic children suggests poor clinical outcome. In a 4 years study among 1041 asthmatic~     children in America carried out by Sharma et al, it showed that compared with individuals who~     had a BDR of 12% and 200ml, individuals who had a BDR of 10% had similar poor clinical~     outcomes (e.g. more hospital visits, more prednisone bursts, increased nocturnal awakenings,~     and missing more days of school). Same results were also obtained in Galant et al study among~     679 asthmatic children among 5-18 years.~   "
157809|NCT01500512|"~     This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph~     node dissection. Sentinel lymph node dissection may have fewer side effects than removing all~     lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors~     confirm the safety of the procedure.~   "
157810|NCT01500499|"~     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in~     the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies the role of biomarkers in disease progression in samples~     from patients with acute myeloid leukemia.~   "
158059|NCT01497210|"~     The primary objective of this study is to evaluate the safety and preliminary performance of~     EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.~   "
157815|NCT01500421|"~     This study is designed to investigate the safty and feasibility of therapeutic hypothermia in~     acute stroke patients. Soon after arrival in the stroke unit patients are randomized to~     either hypothermia in the intensive care unit (ICU) or standard treatment in the stroke ward.~      Patients randomized to therapeutic hypothermia are analgo-sedated and cooled to at~     temperature of 33 degrees for a period of 24 hours.~   "
157816|NCT01500408|"~     Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the~     active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This~     bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and~     pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved~     serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing~     process.~   "
157817|NCT01500395|"~     The purpose of this study is to investigate the short to mid term efficacy and safety of~     different hybrid operations who had complex aortic lesions, such as ascending aortic/arch~     aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection,~     dissection with primary tear located in the aortic arch, et al.~   "
157818|NCT01500382|"~     The study is designed to investigate the effects of the investigational drug vibegron~     (MK-4618) compared to placebo on maximum urinary bladder capacity in women with overactive~     bladder. The study will also evaluate the safety and tolerability of multiple oral doses of~     vibegron in women with overactive bladder. Overactive bladder is best described as urgency~     and frequency of urination, with or without involuntary urination and/or the need to awaken~     during the night to urinate.~      The primary efficacy hypothesis is that vibegron is superior to placebo with respect to~     change from baseline in maximum cystometric capacity at 2 hours postdose on Day 7 (i.e.,~     steady state) in participants with overactive bladder. A true mean increase~     (vibegron/placebo) of 25% in bladder volume is expected.~      The primary safety hypothesis is that administration of multiple oral doses of vibegron is~     sufficiently well-tolerated in participants with overactive bladder, based on assessment of~     clinical and laboratory adverse experiences, to permit continued clinical investigation.~   "
157819|NCT01500369|"~     Atrial fibrillation is the most common arrhythmic complication after coronary artery bypass~     grafting (CABG). Post operative atrial fibrillation (POAF) increases morbidity and mortality.~     Inflammation could be a factor in POAF and recent evidence of remotely inducing ischemia may~     reduce inflammation and cardiac injury. The investigators plan to use a blood pressure cuff~     on the arm as a method to produce remote ischemia and assess the occurrence of POAF for seven~     day.~   "
157820|NCT01500356|"~     The primary aim of this study is to examine the effect of the consensus public health~     recommended level of physical activity [moderate physical activity (MOD-PA) = 150 min/wk]~     versus a higher dose of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in~     the context of a comprehensive behavioral weight loss program that a includes a reduction in~     energy intake measures of cardiovascular function using cardiac MRI and biomarkers of~     vascular disease risk. Each of these exercise doses will be compared independently to a Diet~     Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also~     compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults~     who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for~     a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes~     include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume,~     aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines~     (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body~     composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids,~     glucose, insulin, blood pressure). Additional secondary analyses will allow for examination~     of the effects of physical activity independent of weight change on the primary and secondary~     outcomes.~   "
157821|NCT01500343|"~     The purpose of this study is to evaluate the feasibility, safety and effects in inflammatory~     response of the therapy with a probiotic agent, the yeast Saccharomyces boulardii (SB), in~     chronic heart failure patients.~   "
157822|NCT01500330|"~     The purpose of this randomized controlled study is to determine the effectiveness of cupping~     massage as home use for patients with chronic nonspecific neck pain compared to relaxation~     exercise.~   "
157823|NCT01500317|"~     Tapentadol is FDA approved for the treatment of moderate to severe acute pain. Due to the~     dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor, there is~     potential for off label use in chronic pain.~      Tapentadol is a new molecular entity that is structurally similar to tramadol. Tapentadol is~     a centrally-acting analgesic with a dual mode of action as an agonist at the mu-opioid~     receptor and as a norepinephrine reuptake inhibitor. These two actions are synergistic in~     pain relief. While its action reflects aspects of tramadol and morphine, its ability to~     control pain is more on the order of hydrocodone and oxycodone.~      Its dual mode of action provides analgesia at similar levels of more potent narcotic~     analgesics such as hydrocodone, oxycodone, and meperidine with a more tolerable side effect~     profile. Clinical studies showed that tapentadol effectively relieves moderate to severe pain~     in various pain care settings. In addition, it was reported to be associated with~     significantly fewer treatment discontinuations due to a significantly lower incidence of~     gastrointestinal-related adverse events compared with equivalent doses of oxycodone. The~     combination of these reduced treatment discontinuation rates and tapentadol efficacy for the~     relief of moderate to severe nociceptive and neuropathic pain may offer an improvement in~     pain therapy by increasing patient compliance with their treatment regimen.~   "
157824|NCT01500304|"~     The purpose of this this study is to determine if a structured educational training program~     is successful in teaching surgeons a new operative technique. It will then be determined if~     this new operative technique is safe.~   "
157825|NCT01500291|"~     It is inevitable that nearly both anesthesiologist and nurse anesthetist take a zero~     tolerance approach to avoidable safety problems in the provision of anesthesia.~      We would like to study the stress upon anesthesia personnel by using Suanprung Stress Test~     (SST) - a well-documented, psychological stress test, and Siriraj Anesthesia-related Stress~     Test (SAST) - a new developed open-ended opinion poll, to scrutinize the daily rounds stress~     and yield the solution to eradicate or alleviate those worries as well as improve both~     physical and mental health to handle the situation of difficulties.~   "
157826|NCT01500278|"~     This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy~     of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in~     the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding~     adequately to MTX.~   "
157827|NCT01500265|"~     Nucleotide analogues are associated in the long term with a risk of proximal tubular~     nephropathy (PT) with loss of phosphate, and, when compensatory mechanisms are overwhelmed,~     with osteopenia or osteoporosis. This toxicity has been particularly documented for tenofovir~     (TDF) in HIV disease, but its prevalence varies widely in the literature and is mainly~     associated with comorbidities: on average this prevalence is 0.39% after 48 weeks with~     exceptional cases of Fanconi syndrome described. In HBV monoinfection after 60 months of~     treatment with TDF, an 11% decrease of creatinine clearance (CreatCl) is observed. A single~     study showed a significant increase in creatinine level with entecavir (ETV) therapy, a~     second-generation nucleoside, hitherto not described as nephrotoxic. Furthermore, if the~     direct renal toxic effect characteristic of HIV in the kidney is well known, the role of HBV~     is less clear. Thus, HBV treatment appears to have a renal protective effect. The monitoring~     tools recommended by the SPC, CreatCl and plasma phosphorus level are late markers of tubular~     damage. The threshold of phosphate tubular reabsorption (TmPi/GFR) and the fractional~     excretion of uric acid (FEUA) are unexpensive early screening tools. However, the long-term~     evolution of this subclinical tubular involvement in HBV monoinfection is not known.~   "
157828|NCT01500252|"~     Background:~      Despite the excellent results of total knee replacement, also known as total knee~     arthroplasty (TKA) there is persistent controversy over whether or not to replace the surface~     of the kneecap. Anterior knee pain, which occurs with variable and unpredictable frequency,~     continues to be a problem in a subset of TKA patients. Some clinicians replace the surface of~     all kneecaps during TKA to avoid repeat surgery, which occurs in approximately 10% of cases.~     However, others cite the complications attributed to replacing the surface of kneecap as~     reasons to avoid this procedure.~      This study prospectively randomized patients receiving TKA into two groups, those receiving~     replacement of the kneecap surface and those left without replacement of the kneecap surface~     to determine clinical outcomes and revisions over the first 5-10 postoperative years.~      Objectives:~      The primary objective of this work was to compare pain, stiffness and function between groups~     at five years postoperatively. Secondarily, we compared pain, stiffness and function at one~     and 10 years postoperatively. Finally, we examined the number of reoperations following TKR~     over 10 years in the 2 groups of subjects. The investigators hypothesized that there would be~     no difference between the two groups of subjects in the measured outcomes.~      Methods:~      Patients receiving TKA were prospectively enrolled before surgery and randomized~     intraoperatively to either receive a replacement of the kneecap surface or have no kneecap~     intervention. The Smith and Nephew Profix TKA system was implanted in all cases; the~     post-operative regimen was standardized. Subjects were assessed pre-operatively and at 1 and~     5 years postoperatively for pain, function, and stiffness using a disease-specific (Western~     Ontario and MacMaster Osteoarthritis Index [WOMAC]) and generic health status (Short Form 36~     [SF-36]) questionnaire. At the end of the five year follow-up, the study was extended to a~     10-year followup and the same outcomes were assessed. The revision rate was also compared~     between the two groups at the end of the 10-year follow-up.~   "
157829|NCT01500226|"~     This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled~     study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered~     prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects~     will record all events of emesis and the use of rescue medication for established nausea~     and/or vomiting, and will indicate the severity of nausea they experienced in each of the~     previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to the MEC~     administration through Day 6 in Cycle 1. Health-related quality of life will be measured by~     the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by~     clinical review of adverse events (AEs), physical examination, electrocardiograms (ECGs), and~     safety laboratory values. All subjects are expected to complete Cycle 1 and will have the~     option of participating in up to five additional cycles.~   "
157830|NCT01500213|"~     This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled~     study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2~     hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone.~     Subjects will record all events of emesis and use of rescue medication for established nausea~     and/or vomiting, and will indicate the severity of nausea they experienced in each of the~     previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration~     through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE~     Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical~     review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety~     laboratory values.~      All subjects are expected to complete Cycle 1 and will have the option of participating in up~     to five additional cycles.~   "
157831|NCT01500200|"~     This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to~     adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant~     therapy.~   "
157832|NCT01500187|"~     Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that~     can occur around the edge of fixed orthodontic brackets.~   "
157833|NCT01500174|"~     The objective of the study is to examine the effectiveness of Ultraviolet-C (UVC) for healing~     pressure ulcers in people with spinal cord injury. UVC is a form of radiation similar to~     sunlight but it is normally absorbed in the earth's atmosphere. Participants will be assigned~     by chance to receive placebo-UVC or real UVC treatment, in addition to receiving wound care~     according to best practice guidelines. The hypothesis is that UVC-treated wounds will heal at~     a faster rate than wounds receiving placebo treatment.~      Given that pressure ulcers impact on an individual's quality of life, and generate high costs~     to the overall health care system, further work is needed to explore alternative means of~     pressure ulcer treatment.~   "
157834|NCT01500161|"~     The purpose of this study is to evaluate the multi-lineage hematopoietic chimerism for~     unrelated umbilical cord blood (UCB) grafts pooled from two to three cord blood units. Also~     to evaluate the toxicity, and antitumor responses of pooled unrelated UCB transplants.~   "
157835|NCT01500148|"~     The purpose of this proof-of-concept study is to assess the relative safety and feasibility~     of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.~   "
157836|NCT01500135|"~     Present trial is the third study that in combination with two completed studies (one being a~     trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted~     toward providing clinical safety and efficacy data to support extending the current label of~     TachoSil® to a general hemostasis indication across several surgical procedures and organ~     systems in the USA.~   "
158807|NCT01487408|"~     This study is conducted in Japan. The aim of this study is to evaluate the incidence of~     severe hypoglycaemia episodes under normal clinical practice for patients with type 1 or type~     2 diabetes.~   "
157837|NCT01500122|"~     The primary objectives of the study are:~        -  To compare the pharmacokinetic profiles of RhuDex administered as two novel oral~          formulations~        -  To identify the lead formulation and optimise the pharmacokinetic profile by modifying~          the quantitative composition of that formulation~        -  Optional: To assess the intravenous pharmacokinetics of RhuDex following administration~          of an IV microtracer of [14C]RhuDex~   "
157838|NCT01500109|"~     The purpose of this investigator-initiated study is to determine whether acetaminophen is an~     effective pain reliever for primary cleft palate repair in children and possesses opioid~     sparing effects. Additionally, the investigators will determine if patients who receive~     acetaminophen have less opioid related side-effects. The study will have three study groups~     based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral~     acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine)~     alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the~     intraoperative period and 24 hours after surgery for all patients within the study and~     converted to morphine equivalents.~   "
157839|NCT01500096|"~     The purpose of this study is to determine whether American ginseng is effective in the~     treatment of HIV-associated fatigue.~   "
157840|NCT01500083|"~     The purpose of the current study is to evaluate additional safety data of bendamustine in up~     to 100 patients with Indolent Non-Hodgkin's Lymphoma (iNHL) relapsing from a rituximab~     regimen or Chronic Lymphocytic Leukemia (CLL). Patients will receive up to 6 or 8 cycles of~     bendamustine treatment using the dosing regimens of TREANDA® (bendamustine) approved in~     several countries, which have been shown to be reasonably well tolerated. The study protocol~     includes safety monitoring (i.e., adverse events, concomitant medications, supportive care,~     clinical safety laboratory tests, and clinical disease status monitoring).~      It is an interventional, multicentre, prospective, open-label expanded access study, which in~     addition allows investigators in Canada, and their patients, access to bendamustine while it~     is pending Canadian marketing approval.~      Although the treatment options available for patients with iNHL or CLL do induce substantial~     responses, there is no curative treatment. One potential drug candidate for the treatment of~     CLL and iNHL is bendamustine.~      Bendamustine has been widely used in Germany for more than 30 years and is marketed in the~     United States for treatment of CLL and for treatment of iNHL that has progressed during or~     within 6 months of treatment with rituximab or a rituximab-containing regimen. In October~     2010, the European Medicines Agency formally approved bendamustine in a number of Member~     States of the European Union for the treatment of patients with iNHL, CLL, and multiple~     myeloma. The drug's safety profile in these patient populations has been extensively~     characterized and no unexpected safety concerns are anticipated.~   "
157841|NCT01500070|"~     This is a single-arm, prospective, multi-center monitored trial recruiting patients with~     critical limb ischemia and with one or more lesions in the arteries below the knee. The~     immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting~     Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System~     (Boston Scientific) will be evaluated.~      In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will~     be recruited. Primary endpoint is primary patency at 12 months, defined as absence of~     restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on~     angiography.~   "
157842|NCT01500057|"~     This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus~     BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic~     Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up~     visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.~   "
157843|NCT01500044|"~     The primary objective of this randomised clinical trial (RCT) is to compare, in terms of~     disability and pain, an intervention targeting the opening of intervertebral foramens to a~     conventional physiotherapy intervention, in patients presenting acute or subacute cervical~     radiculopathies. Based on biomechanical principles, the investigators hypothesis is that the~     intervention targeting the opening of intervertebral foramens will be significantly more~     effective in reducing pain and disability than the conventional physiotherapy intervention.~      This study is double-blind RCT that will allow the comparison of patients with a cervical~     radiculopathy randomly assigned to one of two groups: one group will receive a 4-week~     rehabilitation program targeting the opening of intervertebral foramen, and the second group~     will receive a 4-week conventional rehabilitation program. Thirty-six subjects will be~     recruited from participating medical and physiotherapy clinics in the Quebec City area~     (Canada) and will be evaluated at baseline, at the end of the program and four weeks~     following the end of the program. The primary outcome measure will be the validated Neck~     Disability Index (NDI) questionnaire and other secondary measures will include the QuickDASH~     questionnaire, a numerical pain rating scale, cervicothoracic mobility and patients'~     perceived global rating of change.~   "
157844|NCT01500031|"~     Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total~     occlusions in native femoropopliteal arteries.~   "
157845|NCT01500018|"~     This is a single dose, crossover study to assess the abuse potential of TC-5214 compared to~     placebo, ketamine, and phentermine in healthy recreational polydrug users.~   "
157846|NCT01500005|"~     The incidence of type 2 Diabetes Mellitus is increasing at an alarming rate worldwide.~      Cardiovascular disease is the leading cause of death in patients with type 2 diabetes.~      Recently, increasing amount of evidence suggests that vitamin D may influence various~     nonskeletal medical conditions, including cardiovascular disease, hypertension, diabetes,~     cancer, autoimmune disorders and more. The purpose of this trial is to investigate the effect~     of vitamin D supplementation on 24 hours blood pressure monitoring, arterial stiffness,~     oxidative stress and inflammation in vitamin D deficient diabetic patients.~   "
157847|NCT01499992|"~     The aim of this study to define the optimal rehabilitation for clients with full thickness~     rotator cuff reconstruction, with two goals: 1. Finding the optimal physical therapy dosage~     in enhancing post-operative outcomes of shoulder pain, shoulder joint range of motion,~     shoulder muscle strength, upper extremity function; and 2. Finding the effect of aquatic~     physical therapy in enhancing the post-operative outcomes.~   "
158887|NCT01486368|"~     This is a non-randomized open label multicentre Phase II trial to evaluate the response rate~     of PF03446962 in patients with advanced malignant pleural mesothelioma who have been~     previously treated with cytotoxic chemotherapy.~   "
157848|NCT01499979|"~     Rationale~      Currently, hepatic resection is often the only curative treatment for primary or secondary~     hepatic malignancies and is also frequently performed in patients with benign liver tumors to~     prevent malignant transformation and/or alleviate symptoms. Liver resections are nowadays~     associated with low mortality and acceptable morbidity. As result of that, an increasing~     number of patients is currently under consideration for resection of more complex or large~     tumors, thus requiring extensive resection procedures. Application of vascular exclusion~     (i.e., clamping of the portal vein and hepatic artery) during such procedures reduces blood~     loss, which is one of the most important factors affecting peri-operative outcomes. However,~     vascular exclusion leads to ischemia-reperfusion (I/R) injury as an inevitable side-effect,~     which adversely impacts postoperative liver function and regeneration. Additional cooling of~     the liver by means of hypothermic perfusion is expected to further reduce intraoperative~     blood loss, as well as to protect the liver from I/R injury. Therefore, the aim of this pilot~     study is to cool the future remnant liver (FRL) in situ during right hemihepatectomy under~     vascular exclusion. Consequently, an overall improvement in postoperative outcomes is~     expected due to a decrease in intraoperative blood loss, reduced parenchymal damage, and a~     better ability of the liver remnant to regenerate.~      Objective~      To reduce intraoperative blood loss and enhance tolerance of the FRL to I/R injury during~     right hemihepatectomy under vascular exclusion by means of in situ hypothermic perfusion with~     retrograde outflow (R-IHP) of the FRL.~      Study design~      The study is designed as a prospective randomized pilot study in 18 patients (9 interventions~     and 9 controls) to assess the effects of the proposed intervention. Additionally, 4 patients~     will be included separately for assessment of the intervention's feasibility prior to~     randomized inclusion.~      Study population~      Eligible patients for participation in this study are those planned to undergo right~     hemihepatectomy under vascular inflow occlusion because of a malignant or benign liver tumor,~     and who do not suffer from any hepatic co-morbidity that might influence postoperative~     outcomes (i.e., severe steatosis, cholestasis, cirrhosis, or hepatitis B/C infection).~      Intervention~      During right hemihepatectomy, the FRL of patients allocated to the intervention group will be~     perfused with a chilled perfusion solution (i.e., lactated Ringer's solution).~   "
157849|NCT01499966|"~     Until now very few studies have been done to compare the efficacy of tubigrips or plaster of~     paris in the treatment of lateral ankle sprains, the investigators aim to compare the~     tubigrip against plaster of paris in the treatment of lateral ankle sprains.~   "
157850|NCT01499953|"~     The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus~     fondaparinux in the treatment of superficial vein thrombosis (SVT).~   "
157851|NCT01499940|"~     Many patients with cancer that are treated with a drug called oxaliplatin. This drug is used~     with other drugs to treat cancer. The drug can cause problems with the nerves in the hands~     and feet called peripheral neuropathy (a side effect of the drug). Peripheral neuropathy may~     make the hands and feet feel like they are tingling, have a burning feeling, and can cause~     pain. Almost all patients who receive oxaliplatin as part of their cancer treatment have~     peripheral neuropathy. Patients who do have this side effect usually have to take a lower~     dose of or stop taking the oxaliplatin even if the drug is helping their cancer.~      So far there is not a lot of information about how to make this side effect better or help it~     go away completely. There is some information that low levels of Vitamin D in the blood might~     be linked to problems or diseases of the nervous system like multiple sclerosis or~     Parkinson's Disease. It is even thought that Vitamin D may help protect the cells in the~     nervous system. Because of this information, researchers want to see if giving patients~     Vitamin D while they are receiving the drug oxaliplatin to see if it helps prevent the side~     effect peripheral neuropathy.~      Patients taking oxaliplatin who want to be in this study will take one Vitamin D capsule each~     day while they take oxaliplatin. Being in this study will not affect how the patient's cancer~     is treated. There are blood tests in the study to check Vitamin D levels and for a protein~     called nerve growth factor (NGF). The study team will carefully monitor the patients for any~     signs of oxaliplatin-related neurologic toxicity during the study.~   "
157852|NCT01499927|"~     Switching from intravenous application of antiinfective agents to oral therapy is often~     performed late including high costs and risk of complications. This study will investigate~     the impact of displayed reminders in the electronic patient chart after 60h of intravenous~     therapy with an antiinfective agent.~   "
157853|NCT01499914|"~     Multicenter prospective cohort of approximately 1000 cystic fibrosis patients followed in the~     Ile de France during the 2009-2010 influenza season with the main objective to assess the~     effectiveness of antiviral vaccination (H1N1). All subjects will be included, without~     excluding factor. In particular populations at risk are additional infants 6 to 23 months,~     pregnant women and lung transplant will also be included. These people will be vaccinated~     with un-adjuvanted vaccine.~      If flu symptoms until the results of PCR to confirm or refute the diagnosis of influenza,~     oseltamivir is administered in accordance with official recommendations and based on the~     results of the pharmacokinetic study.~   "
157854|NCT01499901|"~     In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The~     impact on perception and language of bilateral CI simultaneous versus sequential has to be~     established before discussing the enlargement of indications.~   "
157855|NCT01499888|"~     The investigators propose to determine the engraftment and transplant related morbidity and~     mortality after a non-myeloablative allogeneic hematopoietic stem cell transplant protocol~     using immune- suppressive agents and low-dose total body irradiation (TBI) without standard~     chemotherapy in patients with aggressive sickle cell disease who are not candidates for or~     experienced complications from hydroxyurea therapy.~      Fully HLA matched siblings will be used as donors for hematopoietic stem cells to reduce the~     risk of morbidity and mortality in this cohort of patients.~   "
157856|NCT01499875|"~     The aim of this trial is to evaluate the pharmacokinetics and pharmacodynamics of penicillin~     V in non-infectious children to estimate the optimum dosage regime in children.~   "
157857|NCT01499862|"~     This pilot study examined the effect of task-oriented mobility training in three persons~     chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion~     Bionic Leg).~   "
157858|NCT01499849|"~     This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled~     study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered~     prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects~     will record all events of emesis and use of rescue medication for established nausea and/or~     vomiting, and will indicate the severity of nausea they experienced in each of the previous~     24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through~     Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire~     on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse~     events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.~      All subjects are expected to complete Cycle 1 and will have the option of participating in up~     to five additional cycles.~   "
158950|NCT01485549|"~     The main objectives are to determine on one hand whether oligomeric alpha-synuclein levels~     are increased in MSA patients compared to controls and on other hand whether there is a good~     agreement between cerebrospinal fluid (CSF) and plasma levels.~   "
157859|NCT01499836|"~     Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain~     and side effects after breast surgery when used in addition to general anesthesia or~     sedation.The investigators would like to further discern the impact of GA or PVB on the~     postoperative QoR, pain and satisfaction.~   "
157860|NCT01499823|"~     The aim of the present study is to assess whether a new method of quantifying~     therapy-associated hemodynamic alterations based on DCE MR imaging may help to distinguish~     pseudoprogression from true progression in patients with high grade glioma, who received~     CCRT.~   "
157861|NCT01499810|"~     Single-center, single group study of the efficacy and safety of transcatheter renal~     denervation for treatment of patients with essential hypertension uncontrolled despite~     combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic.~     Bilateral transcatheter renal denervation will be performed on the top of existed~     pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery~     thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of~     follow-up.~   "
157862|NCT01499797|"~     The purpose of this study is to investigate the effect of the CareWell-programme on overall~     functioning of community-dwelling frail elderly persons. Furthermore, the total costs and the~     cost-effectiveness of the CareWell-programme, in comparison with regular medical care, will~     be studied.~   "
157863|NCT01499784|"~     Urinary incontinence (UI) is a very common condition in women, with estimates of prevalence~     varying from 10% to 40% in most studies and showing a gradual increase with age. UI is a~     serious medical problem that can lead to urinary tract infections, low back pain, respiratory~     disorders, pressure sores, and an increased risk of falls. It also leads to social problems,~     creating embarrassment and negative self-perception for those who suffer from it. Women with~     urinary incontinence find themselves isolated and relatively inactive. A wide range of~     treatments has been used in the management of women's UI, including conservative~     interventions, pharmaceutical intervention, and surgery. A Cochrane Review from 2008 stated~     that pelvic floor muscle training (PFMT) is better than no treatment for UI and supports the~     recommendation that PFMT should be the first treatment line in conservative management~     programs for women with UI. Recently, there have been a few articles published that looked at~     the effectiveness of treating UI in a group-like setting with both behavioral modifications~     and pelvic floor exercises. One study was able to prove that group training of behavioral~     modification helped to reduce UI severity, increase pelvic floor strength, and reduce voiding~     frequency when compared to a control group.~      All of the studies cited were performed in community-dwelling persons with out-patient~     services and interventions. Dr. Fitzgerald and her colleagues from The Rehabilitation~     Institute of Chicago (RIC) were able to confirm in a poster presentation that many patients~     admitted to an inpatient rehabilitation facility do have UI. In 2005, out of 403,697 Medicare~     beneficiaries admitted to a rehab hospital, 24% were incontinent. These studies were able to~     illustrate that UI affects all diagnoses. UI was shown to make a significant contribution to~     patient outcomes independent of functional status at admission. It is also a large~     determinant of discharge destination. In the United Kingdom in 2004, 62% of incontinent~     stroke patients were discharged to a sub acute home with only 5% placement for continent~     stroke survivors. Another study determined that urinary incontinence after having a stroke~     predicted a higher likelihood of an adverse outcome when controlled for age, type of stroke,~     and length of hospital stay. May, et. al., was able to state while in an acute rehab setting~     that patients with spinal cord injuries ranked bowel and bladder care, along with skin care,~     as most important in an education class with 12 different topics. This shows that patients~     find bladder function a large priority in their care, even in an in-patient setting. In the~     poster presentation mentioned above, many patients with UI in an acute care rehab setting do~     not improve Functional Independence Measure (FIM) status from admission to discharge.~     Currently there is no research available for the treatment of UI in an acute care rehab~     hospital, though it has been shown to be an issue with many of those admitted. So the~     question arises, Would addressing urinary incontinence with physical therapy interventions~     and behavioral modifications improve incontinence in this population during the acute rehab~     stage?~   "
157864|NCT01499771|"~     This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets~     (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM~     Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of~     80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin)~     distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80~     mg tablet) in healthy adult subjects when administered under fed conditions.~   "
157865|NCT01499758|"~     This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets~     (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM~     Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of~     80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin)~     distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80~     mg tablet) in healthy adult subjects when administered under fasting conditions.~   "
157866|NCT01499745|"~     -  Idiopathic pulmonary fibrosis (IPF) is a chronic progressive, fibrosing parenchymal lung~          disease with unknown etiology. The prevalence of IPF is estimated between 2-29 cases per~          100,000 in general population with median survival rates of 2-5 years from time of~          diagnosed.~        -  Dyspnea and chronic dry cough are the prominent symptoms in those patients which cause~          to impaired functional capacity and quality of life (QOL).~        -  Drug therapy usually is ineffective approach, what makes a call for an effective~          treatment.~        -  Pulmonary Rehabilitation (PR) had been founded as safe and effective treatment in~          increasing functional capacity, decrease symptoms and improve QOL mainly among Chronic~          Obstructive Pulmonary Disease (COPD). However, recently growing evidence also supports~          the efficiency of PR in IPF patients.~        -  The Aim of the suggested study is to examine the effect of exercise training (ET) at~          ambulatory pulmonary rehabilitation among IPF patients.~        -  The investigators hypothesize that ET at PR program will increase functional capacity,~          will decrease level of dyspnea and improve QOL in IPF patients.~        -  Patients and Methods:~        -  40 IPF patients males and females (aged 30-90 years old) will be recruiting to this~          study. After clinical assessment they will be randomly allocated to PR group n=20 or to~          Control group n=20.~        -  All patients will undergo a clinical assessment including medical history, risk factors~          for IPF and physical examination. On the first meeting at baseline and within one week~          post intervention (PR) the following measurements will be made: dyspnea score, QOL and~          physical activity level questionnaires. In addition, anthropometric measurements,~          echocardiography, blood samples, pulmonary function tests, cardiopulmonary exercise~          test, battery of functional test and 6 minute walk test (6MWT).~        -  The PR group will participate in 12 weeks of supervised group's ET program. The training~          program will be consisted two 6 week blocks of 60 min exercise bout twice a week. In the~          first block the patients will perform aerobic interval training with treadmill walking,~          cycling, and step climbing. In the second block, subjects will perform longer periods of~          continuous aerobic exercise, with resistance training by step climbing, unsupported~          arm/leg exercises with and without dumbbells (0.5-1 kg), and supporting body weight over~          a chair. Pulmonary function test and 6MWT will be also performed after completing first~          6 week block. The control group will be assessed at baseline and after 12 weeks without~          participating in PR program.~   "
157867|NCT01499732|"~     Premature Endothelial Dysfunction is present in patients with early rheumatoid arthritis.~   "
157868|NCT01499719|"~     The purpose of this clinical trial is to evaluate the effectiveness of a new surgical~     checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (CRS) and~     to measure the frequency of compliance by surgical personnel at OHSU with specific daily~     safety protocols before and after introduction of the checklist. The investigators~     hypothesized that the use of an ESS specific surgical checklist will improve the frequency of~     compliance by surgical personnel at OHSU to internal safety concerns and protocols.~   "
157869|NCT01499706|"~     The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to~     rise due largely to~        -  better clinical care and the improved efficacy of highly active antiretroviral therapy~          that has extended the lives of many HIV-positive persons~        -  an increase in the number of new HIV infections in older persons. This study tested the~          efficacy of 1- and 4-session telephone-administered behavioral sexual risk reduction~          interventions for HIV-positive adults 45-plus years of age who engage in risky sexual~          behaviors.~   "
157870|NCT01499693|"~     The purpose of this study is to determine if magnesium pantoprazole 20 mg twice a day~     (b.i.d.), maintains gastric pH above 4 during a longer percentage of time than magnesium~     pantoprazole 40 mg once a day (qd). This is a comparison between split dose concept and~     standard dose of proton pump inhibitors.~   "
157871|NCT01499680|"~     This is a prospective, non-randomized multi-center study to evaluate intraoperative~     neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF)~     surgery at any number of levels inclusive of L4-5.~   "
157872|NCT01499667|"~     This study evaluated disease control during different lengths of treatment transition from~     natalizumab to fingolimod.~   "
157893|NCT01499394|"~     The Biorepository for Caris Life Sciences is designed for the purpose of making quality~     biospecimens and associated clinical data available for research studies related to advancing~     precision medicine and improving care for patients.~      The Caris Biorepository is a repository of prospectively collected biological specimens and~     associated clinical and demographic data gathered from multiple sources to be stored, used~     and shared for research. Caris Life Sciences will maintain the data and specimens and will~     control access to and use of the information and specimens by multiple individuals for~     multiple purposes which may evolve over time.~   "
157873|NCT01499654|"~     This study is recruiting patients already scheduled for a single photon emission computed~     tomography myocardial perfusion imaging (SPECT-MPI) test. SPECT-MPI is a nuclear imaging~     technique that uses a radioactive substance, or radiotracer, and special equipment to create~     three-dimensional (3D) images of the heart. Radiotracer is a radioactive dye that will make~     the structures of the heart visible and is routinely used to view blood flow in the heart,~     scan for damaged heart tissue, or assess heart function.~      For a routine SPECT-MPI test, the radiotracer is given in one dose at the beginning of the~     test, followed by taking resting images of the heart. For this study, researchers would like~     to administer half of the radiotracer, obtain resting images, administer the remainder of the~     radiotracer and obtain a second set of resting images. Participants will receive the same~     amount of radioactive material that would normally be given for this test; however, it will~     be administered in two half-doses. Participation in this study will add about 30 minutes to~     the time it takes to complete the routine test. The investigators expect to enroll about 160~     subjects in this study at Northwestern.~   "
157874|NCT01499641|"~     Focus of this study is evaluation of the outcome, neurologic impairment and safety of~     epidural steroide following lumbar discectomy for herniated disc disease.~   "
157875|NCT01499628|"~     Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in~     the UK, Europe and N America. Low vision patients with AMD have great difficulty reading,~     which leads to a loss of independence and reduced quality of life. Magnifiers alone do not~     compensate for loss of central vision in AMD. It has been proposed that special low vision~     training can improve reading ability in patients with AMD. Training programmes are widely~     available in the US and Scandinavia, but not in the UK, partly because there is a lack of~     evidence from Randomised Control Trials (RCT) showing that they are effective. The~     investigators are conducting a clinical trial comparing the conventional hospital−based low~     vision service to enhanced rehabilitation programmes that include Eccentric Viewing training.~     Eccentric viewing training involves teaching patients who have lost their central vision to~     use a new area of retina for visual tasks. Patients are either taught to improve the use of~     the part of the retina they naturally start using after their central vision is lost, their~     so-called preferred retinal locus (PRL), or, alternatively, they are taught to use a~     different retinal area that is thought to be better suited for everyday visual tasks, the~     so-called trained retinal locus (TRL). The investigators plan to compare the two types of~     eccentric viewing training to conventional hospital-based low vision care.~   "
157876|NCT01499615|"~     Traditionally cardiac output has been estimated with thermodilution. Recently a new~     non-invasive device has been approved by the FDA for use in children of all ages including~     neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous~     physiologic data for all enrolled children by transferring the data from the investigators~     computerized anesthesia records to Excel spreadsheets and to correlate adverse events across~     monitoring devices.~      Secondary outcomes: To determine if the device provides meaningful data in terms of an early~     warning of decreased cardiac output in specific subgroups of children undergoing surgery and~     anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those~     undergoing procedures with expected blood loss, those undergoing laparoscopic procedures~     where gas insufflation may impede venous return to the heart.~   "
157877|NCT01499602|"~     The purpose of this study is to compare the efficacy of the Levonorgestrel releasing~     Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical~     endometrial hyperplasia in perimenopausal women.~   "
157878|NCT01499589|"~     Study of time usage of anesthesia team inside the main operating room compares between 2~     groups of~        -  Performing regional anesthesia inside the operating room~        -  Performing regional anesthesia in the block room~      Study purpose: How much will the investigators save time in the main operating room if we~     perform the regional anesthesia in the block room?~   "
157879|NCT01499576|"~     The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high~     risk group of gastric cancer. Many methods was developed to survey it, including multiple~     gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine~     screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used~     in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The~     investigators have confirmed such whitish discoloration is induced in gastric IM, with~     accuracy > 80% in a pilot study of the investigators. This prospective study will tell the~     accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.~   "
157880|NCT01499563|"~     The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms~     associated with schizophrenia in patients who are having an acute worsening of their~     psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007,~     placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on~     psychosis. The safety of ITI-007 will also be assessed.~   "
157881|NCT01499550|"~     On the basis of different studies the long term oxygen treatment is deemed to be routine~     treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at~     appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in~     hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation.~     Several prospective randomized studies have shown a reduction of acute mortality as result.~     But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom~     oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary~     overinflation or the appearance of depressions or rather anxiety disorders are possible~     causes. On the other hand patients may not notice any subjective improvement of symptoms and~     won't accept the burden of a tight fitting mask during the night. The aim of the present~     study is to determine the effect on gas exchange of a nocturnal transnasal application of an~     oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is~     compared to a nocturnal transnasal application of oxygen alone in randomized order for at~     least 6 hours each night.~      Thirty hypercapnic COPD GOLD IV patients (PCO2 > 50 mmHg) will be included. The two night~     Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements,~     breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At~     begin and end of each measurement night a capillary blood gas analysis is made.~   "
157882|NCT01499537|"~     At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard~     method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail~     or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD) is~     the most commonly used alternative, surgery having higher morbidity and mortality rates,~     unacceptable especially in palliative situation. Recent developments in interventional~     endoscopic ultrasonography (EUS) allow new endoluminal approaches to pancreatic-biliary~     structures, such as cysto-enterostomy or pancreatic-enterostomy. More recently were described~     the possibility to realize EUS-guided biliary drainage, through the duodenal or the gastric~     wall. Advantages of the EUS-guided approach are to be realizable even the papilla is not~     suitable endoscopically (duodenal stricture or post-surgical status) and to allow if~     necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). This technique is~     actually an alternative to PTBD. In comparison of the PTBD, EUS-guided route seems to have~     less morbidity and to avoid external biliary drainage. Indeed, the morbidity rate of the~     percutaneous biliary drainage and the EUS-guided biliary drainage range respectively from 25~     to 35% and from 0 to 23%. However, none study compare prospectively both techniques. Aims of~     this study are to compare the morbidity rate, feasibility and efficacy of these techniques.~   "
157883|NCT01499524|"~     ICP is known to cause abnormal bile acid homeostasis and to be associated with an increased~     risk of diseases of the biliary system in later life. There have been small studies (Dann et~     al. 2006; Wójcicka-Jagodzińska et al. 1989) suggesting that it causes dyslipidaemia (raised~     lipids) and impaired glucose tolerance in pregnancy. However the underlying mechanisms of~     these abnormalities is not known. Similarly the influence of cholestasis on fetal metabolism~     is not known, and nor is the role of the placenta. It is also not known whether women with~     ICP have a predisposition to abnormal lipid and glucose homeostasis when they are not~     pregnant.~      GDM is characterized by raised plasma glucose levels in pregnant women (in the absence of~     pre-pregnancy diabetes mellitus). This condition is associated with large-for-gestational age~     babies and obstructed labour. Women with GDM have increased risk of subsequent type 2~     diabetes mellitus, and if they have this condition in a subsequent pregnancy there is an~     increased risk of stillbirth. This work is important to understand the causes of the~     metabolic abnormalities associated with ICP and GDM. If we demonstrate abnormal lipid and~     glucose profiles, these may be of relevance to the fetal complications of both disorders. It~     will also be of relevance to the future health of affected women and their children.~   "
157884|NCT01499511|"~     ASCOT-10 is a follow-up study of surviving participants in the United Kingdom (UK)arm of the~     Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) which was conducted between 2000 and~     2005.ASCOT's results showed substantial cardiovascular benefit from: 1) the use of a~     cholesterol lowering drug (atorvastatin) compared to placebo, and 2) the use of a~     blood-pressure lowering strategy based on amlodipine when compared to a strategy based on~     atenolol. ASCOT-10 will test the hypothesis that the ASCOT subjects who originally received~     Atorvastatin and those who received amlodipine based treatment will continue to show a~     cardiovascular benefit relative to those who did not, even though all the subjects have had~     access to optimal treatment in the interim.~   "
157885|NCT01499498|"~     This is a healthy volunteer study looking at the interactions between two drugs: boceprevir~     and sildenafil.~      New drugs are being developed to treat people with the chronic viral infection hepatitis C.~     Very little is know how these new treatments interact with other medications such as the~     drugs used to treat erectile dysfunction.~      The purpose of this study is to look at levels of both a new hepatitis C drug called~     boceprevir (BOC) and an existing erectile dysfunction drug called sildenafil to see if they~     affect the blood levels of each other when given separately and together.~   "
157886|NCT01499485|"~     The purpose of this study is to analyze whether the treatment of metabolic alkalosis with~     acetazolamide in intubated patients with chronic obstructive pulmonary disease (COPD) or with~     obesity hypoventilation syndrome (OHS) reduces the length of mechanical ventilation (MV).~   "
157887|NCT01499472|"~     The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added~     to standard of care wound therapy significantly improves time to complete wound healing in~     diabetic foot wounds.~   "
157888|NCT01499459|"~     This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC)~     transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem~     cell will be derived from patients' bone marrows and will be infused via peripheral vein.~     Liver biopsies will be performed in every patient in the beginning and at 6th month.~   "
157889|NCT01499446|"~     The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once~     daily either in the morning or the evening and GW685698X 250mcg administered once daily in~     the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.~   "
157890|NCT01499433|"~     The investigators propose to study the efficacy and safety of three-week antifungal therapy~     with caspofungin in hospitalized patients with proven or probable IPA underlying chronic~     obstructive pulmonary disease.~   "
157891|NCT01499420|"~     Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS)~     may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent~     cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single~     ascending dose study in patients with stable atherothrombotic disease in whom the safety and~     pharmacokinetic profile of CSL112 will be assessed.~   "
157892|NCT01499407|"~     Subjects with ST-elevation myocardial infarction will be randomized, to one of the following:~     abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A),~     thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy~     followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that~     abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration~     (groups C or T+C) will result in a significant reduction of intra-stent thrombus formations~     when compared to intravenous or intracoronary abciximab with or without thrombectomy (groups~     A or T+A). The primary endpoint will be the number of cross sections with thrombus area >10%~     immediately after stent implantation as assessed with OCT. Additional angiographic, ECG, and~     clinical endpoints will be collected and adjudicated. This trial is currently being~     registered at ClinicalTrials.gov.~   "
157894|NCT01499381|"~     The objective of this multi-center prospective observational clinical study is to evaluate~     the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of~     prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results of~     the Carisome Prostate assay will be compared with pathology results of prostate biopsy~     procedures. Secondarily, the performance of the Carisome Prostate test will be compared to~     the current standard of care for the detection of prostate cancer.~   "
157895|NCT01499368|"~     To evaluate the healing rate and safety of Lafutidine in erosive esophagitis~   "
157896|NCT01499355|"~     The primary objective of the study is to assess the efficacy of BIIB023 as an add-on~     treatment to background therapy compared with placebo in combination with background therapy~     in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary~     objectives of this study are to assess the safety and tolerability of BIIB023 compared with~     placebo in this study population.~   "
157897|NCT01499342|"~     This is a Belgian prospective multicentre registry to evaluate safety and performance of the~     Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic~     lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed~     for a period of 2 years.~   "
157898|NCT01499329|"~     The purpose of this study is to evaluate safety and performance of the balloon-expandable~     Zeus CC (Rontis AG) stent for the treatment of Trans-Atlantic Inter-Society Consensus (TASC)~     A, B, C and D iliac lesions.~   "
157899|NCT01499316|"~     Coronary artery disease (CAD) is a condition which refers to the narrowing of the small blood~     vessels that supplies blood and oxygen to the heart. It is a common cause of chest-pain~     related symptoms and as a result of a 'heart attack'. In most cases, to assess the severity~     of the disease is to use coronary angiography, which is a medical imaging technique that uses~     contrast (a dye) and x-ray to show the blood-flow supply of the coronary arteries.~      The optimal treatment for patients with symptomatic coronary disease is aggressive medical~     therapy. Current guidelines recommend patients with symptomatic CAD and severe disease on~     angiography undergo revascularisation therapy, which aims to restore blood flow to blocked~     arteries. This can be done by either percutaneous coronary intervention (feeding a small~     balloon or other device on a thin tube through blood vessels to the point of blockage and~     then inflate the balloon to open the artery), or coronary artery bypass grafting (open-heart~     surgery)2.~      For many symptomatic patients who have only moderate disease on angiography, further~     functional testing is required to assess the extent of the blockage. This can be achieved by~     placing a pressure wire to the artery of interest, to determine the likelihood that the~     blockage impedes oxygen delivery to the heart muscle, known as the Fractional Flow Reserve~     (FFR)3. FFR is commonly performed at the Alfred hospital in the assessment of such patients.~     During an FFR procedure, further information regarding the health of the small arteries of~     the heart can be obtained with the calculation of the index of micro-vascular resistance~     (IMR),~      Giving oxygen to patients with CAD is a common clinical practice, especially to all patients~     in the catheterisation laboratory whose had a 'heart attack' and often administered~     concurrently with light sedation during elective procedures.~      Recently, however, the safety of routine supplemental oxygen in patients with CAD has been~     questioned5. A research study analysed the outcomes of three small randomised studies on~     oxygen in patients who experienced a 'heart attack', while suggestive of harm, the findings~     of the study remain inconclusive.~      There may also be deleterious effects of supplemental oxygen, on more stable patients with~     CAD, who are not experiencing a 'heart attack'. Supplemental oxygen administered in the~     catheterisation laboratory to patients with stable CAD, has been shown to significantly~     reduce coronary artery blood flow and increase its resistance6-8. It has also been shown to~     reduce cardiac output and effect the relaxation phase of the heart cycle. Based on this data~     it is hypothesised that supplemental oxygen may affect FFR in patients with moderate CAD. The~     investigators therefore propose to undertake a study of the effects of supplemental oxygen on~     FFR in patients with moderate CAD.~      The patients enrolled into the study will be scheduled for an elective normal contrast~     diagnostic or interventional procedure as part of their clinically-indicated care. Once a~     moderate blockage of the artery has been identified, FFR and IMR will be measured. During the~     first phase of the FFR study, the patient will breathe room air and have a blood test to~     measure their oxygen level (blood gas). There is a 3 minute washout period, followed by the~     second phase, whereby the patient will be given 100% oxygen for 10 minutes and have another~     blood gas measured.~      The study will be conducted at Alfred Hospital with a total enrollment of 18 subjects. The~     estimated time to complete enrollment is 6-10 months.~      Data collected on each patient will include demographics, medical history, vital signs (heart~     rate, blood pressure, height, and weight), usage of cardiovascular medications, pathology~     results and procedural records. Any adverse events or serious adverse events related to the~     study procedure will also be recorded.~   "
157900|NCT01499303|"~     This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients~     with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large~     B-Cell Lymphoma (abbreviated as DLBCL)~   "
157901|NCT01499290|"~     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus~     Metronidazole compared to Meropenem for treating hospitalized patients with complicated~     intra-abdominal infections.~   "
157902|NCT01499277|"~     The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin~     plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue~     infections.~   "
157903|NCT01499264|"~     Evaluation of clinical efficacy of my skin (hydrogel and polyurethane film) plus best~     practice clinical care in subjects with burn injuries with particular regard to: 1) Wound~     healing (complete reepithelialization), 2) the patient's pain. In the context of the study~     will be collected secondary outcomes related to type of lesion and its clinical evolution~     through the analysis of the items in the scale of the PSST.~   "
157904|NCT01499251|"~     This is an open-label, single arm, Phase 1 study to assess the safety and tolerability of~     macitentan in combination with dose-dense temozolomide in adult patients with recurrent~     glioblastoma or gliosarcoma. The study is composed of three parts. A Phase 1 Dose Escalation~     Period with a traditional 3+3 design will determine the maximum tolerated dose of macitentan~     in combination with dose-dense temozolomide. A Phase 1b Period will expand the safety and~     tolerability data of two doses of macitentan and dose-dense temozolomide selected from the~     Dose Escalation Period and explore efficacy. An Ancillary Study will further evaluate the~     effects of macitentan on biomarkers in brain tumor tissue.~      The study is planned to have a minimum duration of 12 months. The study will end when all~     patients (excluding those prematurely withdrawn or lost to follow-up) in each part of the~     study have completed a visit at month 12 and 30 days of safety follow-up.~   "
157905|NCT01499238|"~     The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with~     wet lung.~   "
157906|NCT01499225|"~     This study is designed to evaluate the efficacy and the safety of YH14642 in Korea patients~     with chronic periodontitis, in order to investigate the recommended therapeutic dose.~   "
157907|NCT01499212|"~     The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio~     1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the~     lateral decubitus position.~   "
157908|NCT01499199|"~     ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be~     conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects.~     Subjects who fulfill eligibility requirements will receive dolutegravir (DTG) 50 mg once~     daily in combination with the fixed dose dual nucleoside reverse transcripatase~     inhibitor(NRTI) abacavir/lamivudine (ABC/3TC) for 96 weeks. One pair of pharmacokinetic (PK)~     samples in plasma and cerebral spinal fluid (CSF) (matching time) for determination of DTG~     concentration will be collected at Week 2 and Week 16. Samples for plasma HIV-1 RNA will be~     collected at Baseline and various time points throughout the study and samples for HIV-1 RNA~     levels in the CSF will be collected at Baseline, Week 2 and Week 16. Safety, additional~     measures of antiviral activity and development of viral resistance will also be evlauated.~     The primary analysis will take place after the last subject completes 16 weeks on therapy;~     additional analyses will be conducted after the last subject completes Weeks 2 and 96 (end of~     study).~   "
157909|NCT01499186|"~     This randomized controlled intervention study in institutionalized elderly investigates the~     effect of 6 months of local vibration therapy applied on the thigh and hip on muscle~     strength, muscle mass, bone density, and functionality.~   "
157910|NCT01499173|"~     Getting to the hospital quickly is the key to treating stroke. African Americans suffer more~     strokes with worse outcomes and receive stroke treatments less often than European Americans.~     This project will work to reduce these health disparities by creating and testing the~     feasibility of a peer-led faith-based behavioral intervention in an African American~     community with a goal to increase calls to 911 so stroke patients can be treated quickly.~   "
157924|NCT01498978|"~     This phase II trial studies how well ipilimumab works when given together with androgen~     suppression therapy in treating patients with hormone-resistant prostate cancer that has~     spread to other parts of the body. Monoclonal antibodies, such as ipilimumab, can block tumor~     growth in different ways. Some block the ability of tumors to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Androgen can cause~     the growth of prostate cancer. Androgen deprivation therapy may stop the adrenal glands from~     making androgen. Giving ipilimumab together with androgen suppression therapy may kill more~     tumor cells.~   "
178700|NCT01225965|"~     To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in~     subjects of the established SALIA-cohort and the preventive effects on lung function decline.~   "
157911|NCT01499160|"~     About a third of patients with breast cancer are usually treated by hormone pills called~     tamoxifen and aromatase inhibitors. Aromatase inhibitors are drugs that stop female hormone~     production. Female hormone or estrogen is an important hormone for the growth of breast~     cancer cells. Letrozole is one of the aromatase inhibitors that is approved by the FDA and~     has been used to treat breast cancer since 1997. However, hormone pills usually work for~     about 6-10 months in most patients. Later on, breast cancer will start to grow again. This~     condition when hormone pills or endocrine therapy no longer work is called endocrine~     resistant breast cancer. The scientists here at University of Maryland have discovered how~     these cancer cells can become resistant to hormone pills. In our laboratory tests, the~     investigators found that lapatinib and everolimus can reverse this resistance and make~     letrozole work again. However, it is not known if the drugs can reverse the resistance in~     humans.~      The purpose of this study is to find out whether the combination of letrozole, lapatinib, and~     everolimus is effective in women with breast cancer when hormone pills no longer work.~      Lapatinib is an anti-cancer drug that is already approved by the Food and Drug Administration~     (FDA). It is the standard of care for the treatment of a particular type of breast cancer~     called human epithelial growth factor receptor 2 (HER2)-positive breast cancer. HER2 is a~     protein involved in the growth of some cancer cells. This study will also include patients~     with HER2-negative breast cancer. This means that the cancer cells in these patients do not~     depend on the HER2 protein. The use of lapatinib in these patients is considered~     experimental.~      Everolimus is also an anti-cancer drug that is approved by the FDA for kidney cancer. Initial~     studies in mice and later studies in women with breast cancer have shown that everolimus may~     also slow the growth of breast cancer. The use of everolimus is experimental in this study.~   "
157912|NCT01499147|"~     New conditioning regimens are still needed to maximize efficacy and limit treatment-related~     deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past~     several years, the investigators have evaluated several new conditioning regimens that~     incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has~     synergistic activity with alkylating agents. Recent data have suggested that fludarabine may~     be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity~     previously observed with cyclophosphamide/ busulfan regimens.~   "
157913|NCT01499134|"~     This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an~     active control, metoprolol succinate, in patients with established lower-extremity peripheral~     artery disease, hypertension, and at least moderate risk for coronary artery disease.~   "
157914|NCT01499121|"~     This prospective single arm study will evaluate the efficacy and safety of sunitinib given on~     an individualized dosing schedule as first-line therapy in subjects with metastatic clear~     cell renal cell cancer. The treatment schedule intent is to maximize dose intensity of~     sunitinib and minimize time off therapy based on individual tolerability using protocol~     directed dose modification criteria. A total of 110 subjects will be enrolled. All subjects~     will continue to receive study treatment until disease progression or withdrawal of consent.~     The primary outcome for this study is progression-free survival (PFS), defined as the~     duration from the date a patient first receives Sunitinib until the date of death or~     confirmed progression according to the RECIST criteria.~   "
157915|NCT01499108|"~     Background: Preclinical blood pressure (BP) data from studies of hypoglycemic effects of~     liraglutide treatment (the LEAD program), revealed a significant antihypertensive potential.~     The time course and the mechanism behind this effect are unknown.~      Objectives: To evaluate the time course of the antihypertensive effect of liraglutide~     treatment in patients with type 2 diabetes~      Design: Open-label study with intervention and subsequent washout period~      Patient Population: 35 hypertensive (SBP ≥130 mm Hg and DBP ≥80 mmHg) patients with type 2~     diabetes.~      Intervention: All patients will be treated with liraglutide 0.6 mg once daily for 7 days and~     will then be titrated to 1.2 mg once daily for 14 days and then titrated to 1.8 mg once daily~     for 4 weeks. This is followed by a washout period of 3 weeks without liraglutide treatment.~      Endpoints: 24-hour blood pressure, natriuresis, extra cellular volume (ECV~   "
157916|NCT01499095|"~     Primary Objective:~        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of~          change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6)~          in adult participants with type 2 diabetes mellitus~      Secondary Objective:~        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of~          occurrence of nocturnal hypoglycemia~   "
157917|NCT01499082|"~     Primary Objective:~        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of~          change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with~          type 2 diabetes mellitus~      Secondary Objectives:~        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of~          occurrence of nocturnal Hypoglycemia~   "
157918|NCT01499069|"~     Nerve growth factor (NGF), prostaglandin E2 (PGE2)and adenosine triphosphate (ATP) levels in~     urine were reported to increase in patients with overactive bladder (OAB). Also,~     administration of the anti-muscarinic agent was reported to decrease urinary NGF and ATP.~      The investigators aimed to explore the value of the urinary NGF, PGE2 and ATP as biomarker~     for predicting the treatment responsiveness and symptom relapse in OAB patients. So, the~     patients can be categorized into responder or non- responder and relapse or non-relapse~     groups. Ultimately, they can receive individualized treatments.~   "
157919|NCT01499056|"~     Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant~     problems. First-line of management for patient with osteoarthritis consists of weight~     reduction, education, and analgesic medication. If necessary, invasive treatment like total~     hip replacement are performed for the patient. The objective of this study was to assess the~     safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip~     osteoarthritis~   "
157920|NCT01499043|"~     The main objective of this study is to evaluate the effects on the body that PLX3397 on male~     subjects with CRPC.~      Secondary objectives include evaluating the safety and tolerability of PLX3397 and the~     antitumor effects that PLX3397 has on the the subjects.~   "
157921|NCT01499017|"~     The primary purpose of this study is to evaluate the safety and tolerability,~     pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy~     volunteers.~   "
157922|NCT01499004|"~     This study will explore the drug behavior and safety following a single dose of three~     different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy~     volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in~     an immediate-release formulation.~   "
157923|NCT01498991|"~     The purpose of this study is to determine if individuals with incomplete spinal cord injury~     (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move~     the affected legs better after 10-13 weeks of treatment with a new robotic therapy device.~      The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete~     SCI will result in improved strength, sensation in the legs, and improved functional gait in~     the treated limbs.~   "
157925|NCT01498965|"~     The Departments of Paediatrics and Child Health, Obstetrics/Gynaecology and Nutritional~     Sciences, University College Cork, and the Department of Dermatology, Trinity College, Dublin~     have a unique and urgent opportunity to form a birth cohort of over 2000 children whose~     growth and maternal health status will have been closely monitored from early pregnancy.~     Longitudinal monitoring of these infants will allow direct investigation of several research~     areas in a way which has not previously been possible in Ireland, or abroad. The~     investigators propose to focus on three main research themes: the effects of intrauterine~     growth restriction, the incidence and prevalence of food allergy and eczema in early~     childhood and the incidence and effects of maternal and infant vitamin D status on the growth~     and health of Irish children. Although the investigators initial proposal will focus on these~     important areas, the formation of this birth cohort will offer many opportunities for further~     research as the cohort grows older. It will form a unique bio-bank of information from Irish~     children collected longitudinally from soon after their conception. The mothers of these~     infants are currently being recruited, which leaves us with a narrow window of opportunity to~     put in place a pathway of investigation for these children. To ignore this opportunity would~     be to lose access to a wealth of information regarding child health and disease. The~     potential for this cohort to provide definitive answers to current, and future, theories of~     disease causation is enormous.~   "
157926|NCT01498952|"~     A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard~     of care in adult subjects with unresectable or metastatic HCC.~   "
157927|NCT01498939|"~     This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics~     after a single dose of insulin detemir in healthy Chinese male subjects.~   "
157928|NCT01498926|"~     This trial is conducted in Europe. The aim of this trial is to compare two formulations of~     insulin detemir containing an isotonic agent in healthy volunteers.~   "
157929|NCT01498913|"~     This study is conducted in Asia. The aim of this study is to review the safety and efficacy~     of Novonorm® (repaglinide) in post-marketing use.~   "
157930|NCT01498900|"~     This study is conducted in Africa and Asia. The aim of this study is to evaluate the~     efficacy, safety and convenience of using repaglinide (NovoNorm®) in type 2 diabetes~     management in routine clinical practice.~   "
157931|NCT01498887|"~     This study will assess the efficacy of fingolimod in patients with short duration~     relapsing-remitting multiple sclerosis who have not been previously treated with~     disease-modifying therapies (DMTs), versus patients with the same disease duration who have~     previously received first-line Disease Modifying Therapies.~   "
157932|NCT01498874|"~     The purpose of this study is to determine whether gevokizumab is effective in the treatment~     of moderate to severe acne vulgaris.~   "
157933|NCT01498861|"~     Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical~     development for the treatment of HIV infection. DTG will likely be used in women on oral~     contraceptives (OC) for birth control. Based on accumulated non-clinical and clinical drug~     metabolism and pharmacokinetic data, there is a low likelihood of drug interaction between~     DTG and most widely used OC drugs. The primary objective of this study is to evaluate the~     effect of DTG administration on the pharmacokinetics and pharmacodynamics of a commonly used~     oral contraceptive product, Ortho-Cyclen (combination of norgestimate and ethinyl estradiol),~     in healthy female subjects. Each subject will participate in a Run-in period (if needed),~     followed by two treatment periods. Approximately 16 subjects will be randomized in a~     cross-over fashion to either Ortho-Cyclen with DTG or Ortho-Cyclen with Placebo for 10 days~     and switch to the alternate treatment for another 10 days. Subjects will return to the study~     center for final follow up evaluations 7 - 14 days after the final dose of study medication.~   "
157934|NCT01498848|"~     We conducted a randomized trial to determine the effect of providing families from Bogota,~     Colombia, with a one month supply of one of two cooking oils, sunflower oil vs. soybean oil,~     on whole blood and saliva fatty acid composition of children. The aims were: 1) assess the~     effect of the oils on whole blood fatty acid composition in children, 2) assess the~     correlation between whole blood and saliva to evaluate if fatty acids measured in saliva~     would be adequate biomarkers of intake. The study was conducted in the context of an ongoing~     cohort study of school children from Bogotá, Colombia (HUM00043252). We conducted an~     intervention trial of 4 week duration. Participant families were randomly assigned to either~     sunflower oil or soybean oil. Families were visited two times during the 4 week period. We~     collected dietary information from the person in the household in charge of food preparation,~     and from the child. At the end of the intervention we collected information on whether or not~     they liked the oil and whether they would be willing to use it, exclusively, for two years,~     to assess acceptability for a longer intervention. We also collected two finger prick blood~     samples and two saliva/cheek cells samples from the child, at the beginning and at the end of~     the study, to evaluate compliance and to assess the impact of the intervention.~   "
157935|NCT01498835|"~     To evaluate the toxicity of sunitinib concurrently given with irradiation for preoperative~     treatment of locally advanced or recurrent soft tissue sarcoma.~   "
157936|NCT01498822|"~     To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment~     Failure Rate in subjects with newly diagnosed partial onset seizures with or without~     secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks~     from the first dose~   "
157937|NCT01498809|"~     This project aims to evaluate the physiological effects of Midodrine administration during~     orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown~     to improve orthostatic symptoms in those with spinal cord injury but the physiological~     mechanisms influenced have not been identified. The investiagtors will examine key~     physiological components influencing orthostatic tolerance. The investiagtors will do this,~     by measuring the baroreflex, and brain blood flow autoregulation (the ability to maintain~     brain blood flow) before during and after the sit-up test. Two sit-up tests will occur; one~     before Midodrine administration, and one after administration of a 10mg dose of Midodrine.~   "
157938|NCT01498796|"~     Our group wishes to test the novel hypothesis that intraoperative use of ketorolac in~     pediatric patients undergoing tonsillectomy reduces post-operative nausea and vomiting,~     postoperative pain scores, subsequent narcotic use, and length of hospital stay without~     adversely affecting post-operative bleed risk, when compared to placebo, in a double-blind,~     randomized controlled trial.~   "
157939|NCT01498783|"~     This is a phase I study to investigate the safety and pharmacokinetics of weekly~     5-fluorouracil (5-FU) administered as a bolus dose in children and young adults with~     recurrent or refractory ependymoma. The results from this study will inform a subsequent~     phase II St. Jude investigator-initiated trial.~   "
157940|NCT01498770|"~     This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK)~     during the post-approval period under conditions of usual practice. The use of asenapine in~     Bipolar Disorder and other indications will be described. To provide epidemiological and~     clinical perspective, use of aripiprazole and other comparator drugs will be described.~   "
157941|NCT01498757|"~     To explore biomarkers predictive of clinical response to Taxane/5-FU/platinum based~     chemotherapy in esophageal squamous cell carcinoma. To identify negative predictive markers~     to 5-FU/platinum/Taxane. To elucidate signal transduction pathway attributable to~     5-FU/platinum/Taxane resistance. To analyze correlation between the quantity of circulating~     tumor cells and circulating endothelial cell precursors and treatment response to~     Taxane/5-FU/platinum based chemotherapy.~   "
157942|NCT01498744|"~     The purpose of this study is to better understand why children develop methicillin-resistant~     Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether~     antibiotics are helpful after the infection is drained in the operating room.~   "
157943|NCT01498731|"~     Acute chest pain is commonly known to be the classic symptom of acute myocardial infarction.~     Of the many patients which visit the Emergency Department because of chest pain, less than~     half do actually suffer from an acute myocardial infarction or acute myocardial ischemia. In~     some patients the acute myocardial infarction can be diagnosed at admission, either because~     of typical changes in their ECG (STEMI, ST-elevation myocardial infarction)or because of~     increased levels of the laboratory value Troponin in their blood (NSTEMI, Non-ST-elevation~     myocardial infarction). Troponin is currently the most important marker to diagnose acute~     myocardial infarction. Unfortunately a lot of patients with suspected acute coronary syndrome~     do not show any ECG or Troponin changes. These patients pose a major problem in emergency~     medicine as they need to precautionally be admitted to a chest pain unit and to be started on~     medical treatment until a second Troponin test after 6-9 hours is available.~      In this study, we investigate the biomarker Copeptin. Copeptin has shown excellent results in~     diagnostic clinical trials assessing its use in various acute diseases. There are three~     important trials showing an excellent negative predictive value of Copeptin in combination~     with Troponin in patients with suspected acute coronary syndrome (Reichlin et al., JACC,~     2009; Keller et al. JACC, 2010, Giannitsis et al. Clin Chem 2011).~      This trial compares two processes of managing patients with suspected acute coronary syndrome~     (ACS), the standard process according to current guidelines and the experimental process~     integrating copeptin as a rule-out marker for acute myocardial infarction into management~     decisions. Main Hypothesis: Patients with suspected ACS who test negative for Troponin and~     negative for Copeptin at their initial presentation to the ED can safely be discharged~     (interventional process). They will not experience more major cardiac adverse events than~     patients who were managed by standard practise (control process)within 30 days after~     admission.~      The Investigators want to test Copeptin in patients with suspected acute coronary syndrome in~     whom the ECG is unspecific and the initial Troponin test is negative. Further patient care~     will be based on the Copeptin result. Patients with a negative Copeptin will be discharged~     into the ambulant care of resident cardiologists.Copeptin positive patients will be managed~     according to standard guidelines for the management of patients with ACS.~   "
157944|NCT01498718|"~     This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70 years)~     adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination~     regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza~     vaccine strains as a prime followed 36 weeks later by the 2012/13 influenza trivalent~     inactivated vaccine (TIV) as the booster injection, as compared to placebo prime followed by~     the 2012/13 seasonal TIV. The hypothesis is that the DNA vaccine will be safe for human~     administration and that the DNA vaccine prime-TIV boost schedule will elicit a better immune~     response than the seasonal TIV alone.~   "
157945|NCT01498705|"~     Approximately 12% of strokes in the United States are hemorrhagic.1 Hemorrhagic stroke can~     lead to multiple complications including fever that is not infectious. Identifying the cause~     of fever can help physicians choose the best care for the patient to try and prevent further~     damage to the already injured brain. Bacterial infection is one possible cause of fever in~     the stroke patient; however an incorrect diagnosis of infection can lead to unnecessary~     antibiotic use. Better screening tools for infection are being developed to help fight the~     problem of antibiotic resistance and unnecessary antibiotic use. Unnecessary use of~     antibiotics in patients increases the risk of adverse events and overall healthcare costs.~     Procalcitonin (PCT) is one such screening tool which has been used previously to help tell~     apart bacterial and nonbacterial causes of infection in other disease states; however, PCT~     has not been studied in hemorrhagic stroke patients. The purpose of this study is to~     understand the progress of PCT in hemorrhagic stroke patients in order to see whether PCT can~     be a useful marker for infection in these patients.~   "
157946|NCT01498692|"~     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™~     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo~     atherosclerotic coronary artery lesions. The lesions can be located in vessels that are~     smaller than average-sized.~   "
157947|NCT01498679|"~     A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate~     the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation~     powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult~     subjects of Asian ancestry currently treated with lowe to mid-strength inhaled corticosteroid~     or low-strength combination therapy.~   "
157948|NCT01498666|"~     The present clinical trial will examine the use of L. reuteri Protectis in children with~     functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri~     Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis~     of functional abdominal pain (FAP).~   "
157949|NCT01498653|"~     A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and~     safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once~     daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently~     treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA combination~     therapy~   "
157950|NCT01498640|"~     The objectives of this study are to assess the safety and efficacy of AA4500 in the~     retreatment of recurrent contractures in joints that were effectively treated with AA4500 in~     a previous Auxilium-sponsored Phase 3 study.~   "
157951|NCT01498627|"~     This study aims to assess whether the use of Cervarix® is associated with a modified risk of~     central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis,~     idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis,~     Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx~     information system.~   "
160801|NCT01461278|"~     Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction~     with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate~     primary open-angle glaucoma.~   "
157952|NCT01498614|"~     Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes:~     Intervention Study With Affect School and Basal Body Awareness~      Background:~      Depression is common in patients with diabetes and is associated with impaired metabolic~     control. Alexithymia has been associated with depression, anxiety, stress related disorders~     and diabetes mellitus. Affect School (AS) is an intervention that may reduce depression and~     alexithymia according to previous research. Basic Body Awareness Therapy (BBA) is a~     stress-reducing technique.~      Purpose:~      Our aim is to: 1. Analyze the prevalence of depression and anxiety and the personality~     variables alexithymia and self image in diabetes patients. 2. Explore correlations between~     these variables and risk factors, including biochemical markers for diabetic complications.~     3. To evaluate an intervention with AS and BBA in patients with diabetes that scored high in~     psychometric self-report tests and at the same time showed impaired metabolic control.~      Method:~      A randomized controlled trial of 350 people with diabetes, 18-59 years, 56% men, 44% women.~     Base-line study: from medical records and the National Diabetes Registry - waist~     circumference, BMI, blood pressure, type and duration of diabetes, diabetes complications,~     other diseases, medications, exercise habits and smoking. Tests - A1c, blood lipids,~     cytokines, hormones, beta-cell antibodies, c-peptide, midnight cortisol (salivary).~     Self-report tests of psychological and personality variables: HAD, TAS-20, SASB.~     Intervention: patients with A1c ≥ 8 and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative~     self-image (SASB: AFF <284) or alexithymia (TAS-20 ≥ 61) were randomized to AS or BBA. AS: 8~     group sessions followed by 10 individual sessions. Instructors were a primary care physician~     and a psychotherapist. BBA: 9 group meetings and 6 individual sessions with a physiotherapist~     as instructor. Post intervention: Self report tests, A1c, cytokines, hormones, cortisol.~   "
157953|NCT01498601|"~     Hypothesis: The investigators hypothesize that the current oral protocol is sub-optimal and~     an enhanced protocol will decrease the incidence of hospital acquired pneumonia (HAP)in the~     acute, non-intubated, care-dependent, neurologically impaired, adult patient.~   "
157954|NCT01498588|"~     Previous studies have shown that chemotherapy has the same effect on treating breast cancer~     whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather~     than after surgery, may allow the patient to have less extensive surgery. The purpose of this~     study is to identify new treatment regimens with better response rates and to find out if the~     combination of eribulin followed by doxorubicin and cyclophosphamide can shrink the size of~     the patient's breast tumor and allow you to preserve your breast. Additionally, by receiving~     chemotherapy before surgery, the investigators will be able to determine if your cancer is~     responsive to chemotherapy.~   "
157955|NCT01498575|"~     The long-term goal of this research is to increase safe driving among novice teen drivers by~     increasing the quantity, quality and diversity of driving practice while accompanied by an~     adult. In order to achieve the long term goal of the study, the investigators have developed~     a web-based intervention program known as Teen Driving Plan (TDP) intended to support high~     quality driving practice.~   "
157956|NCT01498562|"~     Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may~     also assist in overcoming inherent or acquired resistance to gefitinib alone.~   "
157957|NCT01498549|"~     The overall goal of this study is to determine if atomoxetine treatment improves selective~     cognitive functions in abstinent cocaine users, compared to healthy controls. The study will~     also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates~     the cognitive effects of atomoxetine.~   "
157958|NCT01498536|"~     This study seeks to see if a 12-week diet and exercise program improves exercise ability,~     energy level, and quality of life.~   "
157959|NCT01498523|"~     Rationale: Recently, human, animal and epidemiological studies suggested that camel milk has~     a hypoglycaemic activity. However, a mechanism and reasons for this activity have not been~     sufficiently studied. Therefore, a study on a glycaemic and insulinaemic responses of regular~     camel milk and camel milk powder is needed.~      Objective: To explore the glycaemic and insulinaemic responses of regular camel milk and~     camel milk powder in healthy adults.~      Study design: In a randomised, single-blind and cross over design, two hour post prandial~     glucose and insulin responses of 4 treatments (regular camel milk, camel milk powder, regular~     cow milk and glucose) will be measured . Those treatments will be consumed in a portion that~     contained 25g available carbohydrate. Finger-prick capillary blood samples will be taken at~     fasting, and 15, 30, 45, 60, 90, 120 minutes after ingestion of the test product.~     Venepunctures will be taken at fasting, 30 and 75 minutes after ingestion of the test~     product. The measurements will be conducted on 4 separate days with at least 2 days wash out.~      Study population: 20 healthy volunteers aged 18 to 35 years, with BMI between 18.5 to 25~     kg/m2.~      Intervention: The treatments are regular camel milk, camel milk powder, regular cow milk and~     glucose. These are standardized to 600ml containing 25g available carbohydrate.~      Main study parameters/endpoints: Main parameters are postprandial blood glucose and insulin~     responses. Secondary parameters: amino acid composition and glycemic index.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: This intervention is non-therapeutic to the subjects. The risk associated with~     participation is negligible and the burden can be considered low. Before subjects are able to~     participate in this study they will have to fill out a brief questionnaire, and have their~     fasting blood glucose measured, in order to ensure they fit the inclusion criteria of the~     study. Once entering the study, each subject will have to visit the research centre 4 times~     for the postprandial tests. On each measurement day, each subject will be required to have~     fasted for at least ten hours before (an overnight fast). Each subject will have 7~     finger-prick blood samples and 3 venapunctures taken during each visit. A maximum amount of~     50 ml blood is drawn per day.~   "
157960|NCT01498510|"~     The purpose of this study is to develop and evaluate an innovative, web-based self-management~     intervention for opioid-treated chronic pain patients who display aberrant drug-related~     behavior.~   "
157961|NCT01498497|"~     This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse~     events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after~     discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of~     Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the opportunity~     to better understand the natural course of eosinophilic esophagitis and define the treatment~     modalities of eosinophilic esophagitis with EUR-1100, such as the need for chronic~     maintenance or intermittent treatment.~      All subjects who complete PR-021 will be offered the opportunity to participate in this~     study. The duration of this follow-up study is six months, during which subjects will visit~     the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8,~     Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week~     20.~   "
157962|NCT01498484|"~     This is a Phase II trial to evaluate the efficacy and safety of human leukocyte antigen (HLA)~     partially-matched third-party allogeneic Epstein-Barr virus cytotoxic T lymphocytes~     (EBV-CTLs) for the treatment of EBV-induced lymphomas and EBV-associated malignancies.~   "
157963|NCT01498471|"~     This study is designed to evaluate the accuracy of the National Institute for Health and~     Clinical Excellence (NICE) guideline 'red flags' to identify patients at high risk of short~     term serious outcome when presenting in the emergency department (ED) with Transient Loss of~     Consciousness (TLoC). Red flags were defined as ECG abnormality, history or physical signs of~     heart failure, TLoC during exercise, family history of sudden cardiac death at an age < 40~     years and/or an inherited cardiac condition, new or unexplained breathlessness, heart murmur,~     absence of prodromal symptoms in any patient aged > 65 years.~   "
160802|NCT01461265|"~     This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain~     associated with metastatic bone tumors.~   "
157964|NCT01498458|"~     Angiogenesis is essential for the growth of large tumor. A number of anti-angiogenic agents~     are currently under development. Bevacizumab, a humanised monoclonal antibody to vascular~     endothelial growth factor (VEGF), has been shown to improve disease free survival in first~     line metastatic breast cancer when associated with chemotherapy 1. Results of a randomised~     phase II trial combining sorafenib, a tyrosine kinase inhibitor targeting multiple tyrosine~     kinases including VEGFR1, VEGFR2, VEGFR3, with capecitabine have recently been reported 2.~     Compared to capecitabine plus placebo, progression-free survival in the capecitabine +~     sorafenib arm was significantly increased from 4.1 months to 6.4 months. Toxicities were also~     increased, with an incidence rate of grade 3/4 hand foot syndrome of 45% in the capecitabine~     + sorafenib arm compared to 13% in the capecitabine + placebo arm. The increased toxicity~     will most likely limit the clinical use of this regimen.~      Pazopanib is a potent, multi-targeted TKI of VEGFR-1, -2, -3, PDGFR-α and -β and c-kit and~     has recently been approved for the treatment of renal cell cancer in the U.S. In the EU, a~     positive opinion has been issued by the European Medicines Agency.~      A phase II study of GW786034 (pazopanib) in patients with recurrent or metastatic invasive~     breast carcinoma included 19 patients after a maximum of 2 lines of chemotherapy for advanced~     disease 3. Pazopanib 800 mg daily was given continuously.~      A clinically significant rate of stable disease (58%) was detected with a median TTP of 5.3~     months (95% CI: 1.8 - 9.0 months). Four patients treated with pazopanib had SD for ≥ 6~     months, for a clinical benefit rate (CBR), defined as rate of SD for ≥ 6 months or CR or PR,~     of 5/19 (26%), which is at least comparable to sunitinib and bevacizumab (CBR 16% and 17%,~     respectively).~      The pivotal study of full dose (800 mg) daily pazopanib in renal cell cancer reported hand~     foot syndrome of all grades in only 6% of patients 4. The optimally tolerated regimen (OTR)~     of pazopanib was determined when administered in combination with capecitabine and~     oxaliplatin in patients with advanced CRC 5. In patients who received capecitabine (850 mg~     twice daily) plus 800 mg once daily pazopanib combined with oxaliplatin, the incidence of~     hand foot syndrome of all grades was 24%.~      The present study will investigate the combination of pazopanib and capecitabine in advanced~     or metastatic breast cancer with the aim to develop a new treatment option with increased~     efficacy and tolerability.~   "
157965|NCT01498445|"~     The goal of this clinical research study is to learn if combining Spyrcel (dasatinib) and~     Dacogen (decitabine) can help to control CML. The dose level of decitabine will also be~     studied.~      Dasatinib is designed to block the protein that is responsible for chronic myeloid leukemia.~      Decitabine is designed to affect the mechanism that cells use to control the expression of~     certain genes, some of which are important in the progression of CML.~      This is an investigational study. Dasatinib is FDA approved and commercially available for~     the treatment of patients with certain types of CML.~      Decitabine is FDA approved for the treatment of patients with myelodysplastic syndrome.~      The combination of these drugs to treat CML is investigational.~      Up to 84 patients will take part in this study. All will be enrolled at MD Anderson.~   "
157966|NCT01498432|"~     This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. The~     fundamental aim is to assess the therapeutic benefits of Heliox21 and practicalities of gas~     delivery in patients who require non-invasive ventilatory support following extubation on the~     Intensive Care Unit. Thus, the investigators aim to extend our knowledge of the potential~     role for Heliox21 in the post-extubation environment of the Intensive Care Unit. The purpose~     of this study is to answer a specific, clinically relevant question. That is whether Heliox21~     helps to reduce the effort of breathing in the period following withdrawal of mechanically~     assisted ventilation in patients on the intensive care unit.~   "
157967|NCT01498419|"~     The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus~     PA-824 plus pyrazinamide regimen after 8 weeks of treatment.~   "
157968|NCT01498406|"~     Lupus is a disease in which the immune system, which normally fights infection, begins to~     attack healthy cells in the body. This phenomenon is called autoimmunity and what the immune~     system attacks is called the autoantigen. Lupus can affect many parts of the body and often~     affects the skin, with immune cells attacking autoantigens in the skin and causing a rash.~     This rash is often visible to the public because it tends to occur on sun-exposed areas, for~     example a patient's face, chest, and arms. For this reason, among others, skin lupus can be a~     source of disability and poor health related quality of life in many patients with this~     disease. It is not completely understood why or how someone might develop lupus, however~     there are likely many reasons which include their genetics and also the kind of environment~     they live in.~      One such environmental factor, vitamin D, is more commonly known as a vitamin important for~     bone health. However, we are learning that vitamin D has effects all over the body, and is~     also important for a healthy immune system. Low levels of vitamin D have been associated with~     an increased risk of other autoimmune disorders such as diabetes and multiple sclerosis, and~     have also been found to be common in skin lupus patients.~      Vitamin D is made in the skin when it is exposed to the sun, specifically ultraviolet B~     radiation (UVB). The main source of vitamin D for most people is its production in the skin~     because the normal American diet is not high in vitamin D. However, patients with skin lupus~     tend to stay out of the sun because their rash is made worse by sunlight, which is thought to~     produce more of the autoantigens in the skin attacked by the immune system. Additionally, as~     skin doctors (dermatologists) we recommend sun protection to skin lupus patients to minimize~     sun-sensitivity and prevent flares of their skin disease. However we may be putting them at~     risk for low vitamin D status and even more severe disease. Another risk factor that puts~     skin lupus patients at risk for vitamin D deficiency is that these patients generally have~     darker skin types which blocks UVB and further limits vitamin D production in the skin.~      Given that skin lupus patients are at high risk for low vitamin D status as mentioned above,~     the investigators propose a research study that will provide information about vitamin D~     levels in these patients. The investigators seek to identify how many skin lupus patients~     have low vitamin D status and how vitamin D influences the natural history of this skin~     disease. Additionally the investigators will evaluate whether or not supplementation with~     high dose vitamin D will lessen the severity and negative quality of life impact of skin~     lupus. Supplementation of vitamin D by mouth is an inexpensive, well tolerated, and safe over~     the counter method to replete and maintain a normal vitamin D status. Studies in other~     autoimmune diseases, specifically Crohn's disease and multiple sclerosis, have shown that~     high dose vitamin D supplementation improves disease severity. It is the hope of the~     investigators that this will also be observed in skin lupus patients.~      In summary, the investigators seek to move beyond establishing an association between vitamin~     D status and skin lupus. The investigators aim to elucidate the therapeutic benefit, if any,~     of vitamin D status on disease severity and quality of life while controlling for important~     factors that may influence vitamin D status. If the investigators are to show improvement in~     disease severity with vitamin D supplementation, this would be a cost-effective additional~     therapy to our standard clinical practice. Future research would also allow us to investigate~     other alternative markers of vitamin D deficiency and disease activity in skin lupus~     patients, a population at high risk for low vitamin D status and in need of further research.~   "
157969|NCT01498393|"~     The purpose of this clinical study is to improve the appearance of onychomycosis and~     morphology of the nail (fungal infection). The researcher can use a light based therapy to~     gently heat the toenail infected with fungus to improve the appearance of onychomycosis.~   "
157970|NCT01498380|"~     Dexmedetomidine is a sedative drug that has many benefits when given to children under~     anesthesia, such as improved pain relief and reduced agitation following their surgery. It is~     usually given as an intravenous infusion over 10 minutes, to avoid the changes in heart rate~     and blood pressure that are occasionally seen when it is administered more quickly. However,~     this is often infeasible and usually inconvenient. The investigators aim to determine the~     dose of dexmedetomidine that can be given rapidly (over 5 seconds) without causing~     significant changes in heart rate and blood pressure. This will be the only study specific~     intervention.~   "
157971|NCT01498367|"~     To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified,~     centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and~     whether this intervention produces health and economic benefits when introduced without major~     changes to the existing organization of a large tertiary care center.~   "
157972|NCT01498354|"~     Introduction: The usual surgical technique for large adenomatous tumors and rectal cancer is~     anterior resection of the rectum or abdominoperineal resection. These techniques are~     associated with high mortality and morbidity and with genitourinary dysfunctions.~      To solve these problems, transanal endoscopic microsurgery (TEM) was designed. Through its~     3-D vision system using a rectoscope, this procedure allows access to rectal tumors located~     up to 20 cm from the anal verge. It is associated with minimal morbidity and has few~     repercussions for anal continence.~      The use of 2-D high definition cameras and screens obtains images of a similar quality to 3-D~     images. This means that from the surgical point of view the procedure known as TEO (transanal~     endoscopic operation) seems as practicable as classic TEM.~      Main aim: To assess the effectiveness of 2-D high definition vision systems (TEO) versus~     conventional 3-D (TEM) in endoscopic surgery of rectal tumors, with respect to surgical~     facility, postoperative morbidity, quality of the surgical specimens, and cost.~      Design: Prospective, controlled, randomized study of the efficacy of the use of 2-D high~     definition endoscopic systems versus 3-D (TEM) in transanal endoscopic surgery.~      Disease studied: Rectal adenomas and adenocarcinomas in situ suitable for local surgery.~      Main variable evaluated: Cost per procedure assuming similar surgical efficacy and equal~     postoperative morbidity.~      Study population and total number of patients: Patients diagnosed with rectal tumor treated~     with curative intent (rectal adenomas and adenocarcinomas in situ). The total sample~     calculated for the trial was 36 patients, 18 in each group (TEO and TEM).~      Timing and expected finish date: After approval by the CEIC, the expected date for the~     inclusion of the first patient was August 2010. The study is expected to last 18-24 months.~   "
157973|NCT01498341|"~     The purpose of this study is to identify the number of persons in Denmark with the diagnose~     hypoparathyroidism, autosomal dominant hypocalcaemia or pseudohypoparathyroidism. Also the~     investigators want to identify the causes and symptoms of these patients and their prognosis.~   "
157974|NCT01498328|"~     The purpose of this research study is to find out whether adding an experimental vaccine~     called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve~     progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII~     positive glioblastoma.~   "
157993|NCT01498081|"~     This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115~     will be tested versus placebo and active comparators. The safety and tolerability of AZD2115~     including investigations of clinically relevant systemically mediated effects will also be~     investigated.~   "
158411|NCT01492569|"~     This randomized pilot clinical trial studies giving acupuncture in reducing nausea and~     vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an~     acupuncture point on the inside of the wrist may help control nausea and vomiting during~     chemotherapy.~   "
157975|NCT01498315|"~     Hysterectomy is one of the common operations in gynecology. With population aging in modern~     society, the incidence of these surgeries is expected to increase even more. One of the major~     complications of pelvic surgery is symptomatic pelvic hematoma, which can present with pain,~     fever, and foul smelling discharge. The incidence of pelvic hematoma is 40%, and varies~     according to the type of hysterectomy and the diagnostic procedure. Those hematoma increase~     the risk for infection. Diagnosis usually is not a clinical one unless symptoms occur, and~     then the diagnosis is made by CT or ultrasound. Number of interventions are mentioned in the~     literature to try and decrease post operative complications and infections, none have~     suggested effective enough. This is a prospective study which objective is to characterize~     the incidence of pelvic hematoma following hysterectomy using ultrasound. The investigators~     will also try to identify preoperative, intraoperative and postoperative risk factors for~     infection of this hematomas. This identification might decrease the incidence of~     postoperative hematoma and infection.~   "
157976|NCT01498302|"~     RATIONALE: Diagnostic procedures that find residual disease may help predict if the disease~     will come back in patients diagnosed with acute myeloid leukemia.~      PURPOSE: This research trial studies the comparison of laboratory test results for minimal~     residual disease in samples from patients with acute myeloid leukemia.~   "
157977|NCT01498289|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil,~     irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Combining more than one~     drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy~     is more effective in treating tumor cells.~      PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and~     fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients~     with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.~   "
157978|NCT01498276|"~     Background:~      - Family-based approaches to reduce disease risk and promote healthy behaviors may be better~     than targeting individuals. Risk assessments based on family health history may help educate~     families on disease risks and encourage them to change physical activity and food choices.~     Specifically, researchers want to better understand the role of mothers in teaching healthy~     behaviors to their families.~      Objectives:~        -  To determine mothers influence on diet and health-related behaviors.~        -  To study an intervention tool that connects family health history and disease risk.~      Eligibility:~      - 18 years of age who have at least one child living at home.~      Design:~        -  Participants will complete a survey over the phone. The survey will take 30 to 40~          minutes to complete. The survey will collect family health history on heart disease,~          diabetes, colorectal cancer, and breast cancer.~        -  Researchers will give participants a Family Health Package (FHP). The FHP will provide~          information on family health history and disease risk. It will also recommend behaviors~          that can reduce health risks.~        -  Two weeks after sending the FHP, participants will complete a phone survey about the FHP~          materials and their social networks.~        -  Some participants will be invited to focus groups. The focus groups will explore diet~          and health behavior. They will look at food purchasing and preparation and meal sharing.~          The groups will also discuss attitudes toward healthy eating and physical activity. Each~          focus group will last 1 to 2 hours.~        -  Participants will be asked to complete an electronic survey regarding participants~          health status, causal health beliefs, risk perceptions, and intentions to communicate~          health information.~        -  Then, participants will have the opportunity to use the electronic version of the FHP,~          which will assess family health history.~        -  After using the FHeP, participants will complete a short electronic survey to identify~          knowledge and understanding gained from the use of the application, changes in~          communication intentions, and suggestions for improvements to the application.~        -  Upon completion of the electronic portion of the study, a study team member will conduct~          a semi-structured interview to allow the participants to qualitatively evaluate their~          user experience, including satisfaction and usefulness.~        -  This study process will take approximately 60-90 minutes....~   "
157979|NCT01498263|"~     Approximately 66 million informal caregivers care for someone who is ill, disabled, or aged.~     These caregivers experience significant distress associated with caregiving, which may be~     particularly salient in the context of inherited conditions. Previous studies have not~     examined caregiving from a network perspective, nor have they considered how cognitive and~     emotional responses, such as caregivers worry for themselves and relatives acquiring the~     disease or guilt related to the genetic etiology of their child s illness, as possible~     stressors; the current project fills this literature gap.~      Caregiving processes may vary across type of illness and the life course. In illnesses that~     impact children, parents and grandparents may take on caregiving roles whereas in conditions~     that impact adults, spouses and adult children may provide care. Caregivers must adapt to the~     strain of caring for their affected relatives and this adaptation may differ depending on~     caregiver roles. The caregiver s support network may influence adaptation, impacting the~     health and well-being of patients, their caregivers, and other relatives.~      This project, comprised of 4 substudies, will examine social contexts surrounding families~     involved in caring for individuals with chronic inherited conditions from a relational~     perspective. Surveys and interviews will assess participants cognitions and emotions about~     the disease, caregiving burden and caregiving/support network systems. In addition,~     biomarkers will be considered in 2 substudies to examine how caregiving roles and~     expectations impact health among caregivers.~      We aim to recruit at least 3100 participants through residential/daycare centers, advocacy~     groups, and the NIH Clinical Center. We will recruit formal caregivers, multiple biological~     and non-biological adult relatives of patients and normally developing controls to construct~     and evaluate caregiving/support network systems. This project will use a social network~     framework to develop and adapt common measures of caregiving roles to evaluate burden,~     perceptual bias, and unmet expectations in caregiving. The psychometric properties of these~     new measures, characteristics of family caregiving and support networks, and how these~     network characteristics are associated with caregiving strain and well-being, including~     biomarkers of physical health, will be investigated. The moderating role of family members~     cognitions and emotions and disease context will be considered. Findings will guide future~     research to develop network-based interventions promoting positive adaptation to the presence~     of inherited conditions in families through improved social environments and coping skills.~   "
157980|NCT01498250|"~     Perturbations in microRNA (miRNA) expression profiles has been reported for a variety of~     cancers. This study will be an exploratory analysis of miRNA expression in basal cell~     carcinoma by miRNA expression profiling using microarrays.~   "
157981|NCT01498237|"~     The purpose of this research study is to evaluate whether a new technology called~     intrauterine photoacoustic endoscopy (PAE) can be used to evaluate the inner lining of the~     uterus.~   "
157982|NCT01498224|"~     This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure~     Sealant compared to sutures for preventing incision leakage within the first 7 days of~     cataract surgery.~   "
157983|NCT01498211|"~     Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this~     density is used to diagnose small fiber neuropathy, despite the absence of normative data in~     a selected normal population. To establish a normative set of data matched for age and sex is~     absolutely needed to evaluate the sensibility and specificity of this test.~   "
157994|NCT01498068|"~     The purpose of this study is to determine the effectiveness, safety and tolerability of~     telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated~     interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced~     Russian participants with genotype 1 chronic hepatitis C.~   "
157995|NCT01498055|"~     To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung~     cancer.~   "
158060|NCT01497197|"~     This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label,~     comparative trial which primary objective is to generate data on the ovarian stimulation~     profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced~     reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).~   "
157984|NCT01498198|"~     The overall goal of this proposed randomized study is to determine if surgery at the time of~     diagnosis or rehabilitation +/- surgery (i.e. surgery only when rehabilitation fails) results~     in shorter times to claim closure. The study will examine how often non-operative management~     is successful in resolving symptoms and allowing subjects to return to work without surgery.~     The investigators will also examine if there are subject, tear or work-related~     characteristics that affect the outcome of rehabilitation or expedited surgery and predict~     whether patients should be referred to operative or non-operative management at time of~     assessment. At study completion, the investigators expect to be able to definitively state~     the best management for subjects with these less serious RC tears.~      The specific research questions to be addressed are as follows:~        1. In WCB subjects with high grade partial thickness (>50%) or small full thickness (≤ 1~          cm.) rotator cuff tears, how does non-operative management (i.e. rehabilitation) or~          expedited surgery affect time to claim closure?~        2. Are there subject, tear or work-related characteristics that affect which patient~          management approach will be most effective and efficient?~   "
157985|NCT01498185|"~     To obtain safety and tolerability information in patients with type 1 diabetes where~     Dapagliflozin is added on to Insulin (for 14 days)~   "
157986|NCT01498172|"~     In this study, the investigators would like to assess how intravesical BCG schedules after~     immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together~     with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell~     responses both systemically and locally in the bladder.~   "
157987|NCT01498159|"~     This research evaluates a diabetes management intervention designed to improve medication~     adherence and intensify therapy to reach goals in blood sugar, blood pressure, and~     cholesterol levels. This study will determine the benefit and cost of adding community health~     promoters to pharmacist disease management services. If there is benefit, then this approach~     may help reduce the burden of diabetes and its related complications among minorities with~     diabetes.~   "
157988|NCT01498146|"~     The SURPRISE study investigates atrial fibrillation(AFIB) in patients with a previous~     unexplained stroke. It uses long term monitoring of the heart of up to three years, searching~     for paroxysmal atrial fibrillation(PAF) otherwise undetected in this population.~   "
157989|NCT01498133|"~     BACKGROUND Decolonization with topical antibiotics is necessary to prevent and / or control~     outbreaks of multidrug-resistant bacterial infection in the NICU (Neonatal Intensive Care~     Unit), but can trigger bacterial resistance. The objective of this study was to determine~     whether skin-to-skin contact of newborns colonized with MRSA (Methicillin-Oxacillin Resistant~     Staphylococcus Aureus) with their mothers could be an effective alternative for biological~     control of bacterial colonization.~      METHODS: The investigators studied 102 newborns admitted to NICU in three public hospitals in~     São Luís, Brazil. Inclusion criteria were birth weight from 1300 to 1800g, length of stay >4~     days, newborns colonized by Staphylococcus aureus and/or Staphylococcus coagulase-negative~     methicillin-oxacillin resistant and mothers not colonized by these bacteria. Randomization~     was performed using a computer generated random numbers algorithm. Allocation to intervention~     and control groups was performed for each eligible newborn using a sealed opaque envelope. In~     the intervention group (n = 53) mother-infant skin-to-skin contact was held twice a day. The~     control group (n = 49) received routine care without skin-to-skin contact. There was no~     masking of newborn's mothers or researchers, but the individuals who carried out bacterial~     cultures and assessed results were kept blind to group allocation.~      The primary outcome was decolonization of newborns' nostrils after 7 days of intervention.~     Safety was assessed by monitoring vital signs of newborns during the intervention. The~     secondary outcome was emergence of late onset presumed sepsis until the end of~     hospitalization period or 28 days of life, whatever happened first.~      FUNDING: CNPq (Brazilian Research Council) and FAPEMA (Maranhão Research Foundation)~   "
157990|NCT01498120|"~     This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up~     study of monotherapy administration of rotigotine transdermal patch in adolescents with~     Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of~     Rotigotine treatment in adolescents with RLS.~   "
157991|NCT01498107|"~     This pilot study investigates a new platform for supporting online interventions for common~     mental health problems called SilverCloud. It was developed from insights into interactive~     system design to address the problem of high attrition rates and poor engagement with online~     interventions. Through a range of methods, the study considers the role of four design~     strategies in engaging users in cognitive behavioural therapy. A service-based study, it~     concentrates on a clinical population with mild or moderate depression. Clinical outcome~     measures will be taken pre and post intervention use; demographic data of who did and did not~     choose the intervention collected, patterns of usage will be extracted from the log data and~     analysed; and qualitative interviews will be done to understand the relationship between~     patterns of usage and levels of engagement. The findings will be used to inform further~     developments of this and other online interventions and contribute to the development of~     methods for assessing online interventions.~      The objectives of the pilot study are:~        -  To evaluate engagement with the online intervention in a realistic primary mental health~          care setting~        -  Assess engagement from multiple perspectives, including clinical efficacy and~          interaction design~        -  Contribute to further development of the online intervention~        -  Support preparation for a full-scale clinical trial~      Research questions include:~        -  Does the online intervention decrease symptoms of depression?~        -  Who chooses to use the online intervention?~        -  What are the patterns of use of the online intervention?~        -  How successful are the four design principles, personal, interactive, supportive and~          social, in supporting engagement?~   "
157992|NCT01498094|"~     Bronchiolitis is a common illness of the respiratory tract caused by infection of the tiny~     airways within the lungs called bronchioles. At present the standard care of hospitalized~     children with bronchiolitis is oxygen via nasal prongs. In this study the investigators would~     like to compare standard ward management with a new method of delivering oxygen called high~     flow nasal cannula oxygen therapy (HFNOT). HFNOT involves breathing warmed, moistened oxygen~     through nasal cannulae at a flow rate of 8 liters/minute. Accumulated experience suggests~     that HFNOT eases the child's work of breathing and reduces need for ICU admission and~     invasive respiratory support.~   "
157996|NCT01498042|"~     Stroke is among the most disabilitating diseases worldwide in terms of numbers affected and~     its consequences. A relatively new and well documented treatment of acute ischemic stroke~     today is tPA (tissue plasminogen activator; will be called thrombolysis from now on)~     Unfortunately only a minority of patients is given this treatment.~      The large randomised controlled trials that investigated the safety and efficacy of~     thrombolytic therapy in treatment of acute stroke did not include patients over 80 years. In~     an aging population in the western world it will be of importance to investigate whether this~     treatment is safe and effective in this group.~      Both Sorlandet hospital Kristiansand Norway and Bergen hospital have administered~     thrombolysis to selected patients over 80 years the last years. In addition there has been a~     registration of patients in stroke registers at both locations. This lays a foundation for~     further investigation. In association with Bergen the investigators have included 77 patients~     over 80 years treated with thrombolysis. In addition the investigators have 85 patients~     treated with tpa below 80 years. In our cohort the investigators are going to compare outcome~     in the 2 groups. In addition the investigators are going to perform a regression analysis of~     selected variables to see if there is an association of those variables with predefined~     outcome measures. Our outcome measures is as follows: mRS=6 (death)and mRS 0-1(good outcome)~     on 3 months control. The third outcome measure will be developement of sICH secondary to tPA~     treatment. As definition of sICH we have chosen the same definition as Ecass.~   "
157997|NCT01498029|"~     The Cartilage Autograft Implantation System (CAIS) is a single-stage procedure in which~     cartilage is harvested from non-critical regions of articular cartilage, but then immediately~     morcellated and loaded onto a polymer membrane-scaffold, which is subsequently used to fill~     the chondral defect. The autograft-membrane composite is fixed to the defect with a~     biodegradable staple.~      The investigators aim to evaluate this new technique through a pilot clinical trial involving~     36 patients randomized into microfracture and CAIS treatment arms (randomisation ratio 1:2),~     with a minimum follow-up of 1 year, using both clinical and radiological (magnetic resonance~     imaging) outcomes. If the results of this pilot trial are successful, the investigators plan~     to expand the study by recruiting more patients to achieve a suitably-powered trial.~      Primary hypothesis 1: That functional scores will increase by at least 0.5 SD over~     pre-operative values, by 1 year following the CAIS procedure~      Primary hypothesis 2: That articular cartilage height will have a sustained increase of at~     least 2 mm at 1 year following the CAIS procedure~      Primary hypothesis 3: That functional scores in the CAIS group will be equivalent or superior~     to those in the microfracture group~   "
157998|NCT01498016|"~     Intravenous Busulfan (iv-Bu) is commonly used as part of preparation regimen for allogeneic~     hematopoietic stem cell transplantation for patients with acute leukemia. Though the~     pharmacokinetics data are available for population from America, Europe and Japan or Korea in~     Asia, there are no data in Chinese population. It is shown that high Bu concentration are~     associated with the toxicity such as veno-occlusion disease and lower concentration is~     correlated with reduced anti-leukemia effect, thus the monitoring of Bu and/or the strategy~     to achieve an optimal target Bu concentration are accepted to avoid toxicity while maintain~     the anti-leukemia effect which may overall improve the outcome of allo-SCT. Thus we conduct~     the pharmacokinetic study in Chinese population.~   "
157999|NCT01498003|"~     Periprocedural myonecrosis or infarction are associated with short, intermediate, and long~     term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural~     CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the~     investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence~     of periprocedural infarciton in elective patients with long coronary lesions treated by~     overlapping use of drug-eluting stents.~   "
158000|NCT01497990|"~     This study will examine the pharmacokinetics of ertapenem in ventilated badly (> 30% SCT)~     burn patients.~   "
158001|NCT01497977|"~     The goal of the study was to assess the impact of soy and red clover derived phytoestrogens~     on serum lipids in postmenopausal women. Both soya and red clover have high phytoestrogen~     content. Phytoestrogens, a class of estrogenic molecules produced by plants bind to the~     estrogen receptor and are capable of producing estrogenic effects. Therefore, our hypothesis~     was that they can reduce the levels of serum lipids.~      Materials and Methods: Researchers investigated total cholesterol, cholesterol fractions and~     triglycerides in blood, before treatment and in six months periods, throughout 18 months. The~     study involved 74 healthy postmenopausal women, divided into three groups. The first group of~     23 patients received red clover derived isoflavones, the second one with 26 patients got soy~     derived phytoestrogens, while the third, control group with 25 patients, was without~     medications.~   "
158002|NCT01497964|"~     Primary Objective:~      - To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response~     rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in~     patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens~      Secondary Objectives:~        -  To determine the RD of cabazitaxel when administered as a single agent every 3 weeks~        -  To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks~        -  To estimate the overall survival (OS) and progression free survival (PFS)~        -  To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1~   "
158003|NCT01497951|"~     Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to~     re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical~     removal is not always possible. The photodynamic therapy uses a special substance, which is~     absorbed in cells, and thereafter activated by a defined light. The aim of this study is to~     compare the photodynamic therapy in potentially malignant lesions to a placebo. The~     investigators assume a significant better result in photodynamic therapy then treatment with~     a placebo.~   "
158014|NCT01497808|"~     The primary objective is to determine the maximum tolerated hypofractionated radiotherapy~     dose (MTD) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in~     metastatic melanoma patients without brain involvement The secondary objectives are to~     determine late toxicity, immune-related clinical responses and immune pharmacodynamic changes~     after hypofractionated radiotherapy followed by ipilimumab~   "
158412|NCT01492556|"~     The purpose of this study is to determine whether Etoposide Monotherapy is effective and safe~     in the treatment of recurrent or metastatic breast cancer in Chinese female patients.~   "
158004|NCT01497938|"~     Introduction:~      The purpose of the pivotal In Home study is to collect clinical data on the safety and~     efficacy of the Paradigm LGS System in the actual use environment and by the intended use~     population. ASPIRE is a multi-center, in home, randomized parallel adaptive study design with~     type 1 diabetes. The study will compare A1C and CGM based nocturnal hypoglycemic events in a~     treatment arm to a control arm. Arms are defined as:~        -  Treatment Arm (LGS ON) using Paradigm® VEO™ Pump~        -  Control Arm (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump~      The study's objectives are two-fold:~        1. The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS)~          is safe and is not associated with glycemic deterioration, as measured by change in A1C~          from baseline to end of study participation.~        2. The second study objective is to demonstrate that home use of Low Glucose Suspend (LGS)~          is associated with reduction in nocturnal hypoglycemia when patients fail to respond.~      Primary Safety Endpoint:~      The change in A1C from randomization to the end of the treatment period will be used to~     demonstrate that the automatic insulin delivery suspension (LGS ON) does not result in an~     unacceptable worsening of glycemic control.~   "
158005|NCT01497925|"~     This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors~     with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize~     that the combination will result in greater tumor cytotoxicity with an acceptable toxicity~     profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of~     action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20~     and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that~     this will be particularly relevant in CRPC.~   "
158006|NCT01497912|"~     Patients with type 1 diabetes are at increased risk of vascular complications both in the~     micro- and macrocirculation. Hyperglycemia plays a major role in the development of these~     vascular complications, but other factors such increased platelet adhesion and aggregation,~     elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin~     generation, dyslipidemia and endothelial dysfunction may contribute.~      Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in~     individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and~     vasculature that are independent of their lipid-lowering properties.~      The aim of the present study was to investigated the effects of intensive~     LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary~     variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia.~     Furthermore, the effects of atorvastatin therapy on skin microvascular function was also~     investigated.~   "
158007|NCT01497899|"~     The primary objective of this study is to evaluate the efficacy of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose~     combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate~     (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.~   "
158008|NCT01497886|"~     Despite the abundance of stroke education materials available, studies continue to reveal~     severe deficiencies in stroke literacy (knowledge of symptoms, urgent action, and prevention~     measures). Expensive mass media stroke education campaigns are not sustainable for this~     purpose, particularly in economically disadvantaged populations. Instead, the investigators~     propose to intervene in school classrooms with children aged 9 to 11 years, to teach the five~     cardinal stroke symptoms, the correct course of action when they occur, and to highlight the~     potential therapeutic benefit of early hospital arrival, with the intent that the children~     will then educate their parents. To help accomplish this, the investigators have developed a~     program called Hip Hop Stroke (HHS), which is comprised of rap songs and two animated musical~     cartoons that incorporate stroke knowledge.~      Hypotheses:~      Hypothesis 1. No differences in baseline knowledge will exist between the parents assigned to~     the intervention and control arms or between the children assigned to the intervention and~     control arms.~      Hypothesis 2. Children in the intervention arm will demonstrate greater knowledge immediately~     after and at three months after the intervention concerning stroke symptom identification and~     response compared to those in the control arm.~      Hypothesis 3. Compared to students in the Control condition, children in the intervention arm~     will be more likely to communicate stroke information to their parents (assessed at 1-week~     follow-up).~      Hypothesis 4. In homes in which such communication has been enacted, parents in schools~     assigned to the intervention arm will demonstrate greater ability to name the symptoms of~     stroke and appropriate action, compared to their baseline knowledge, at 1 week and at 3~     months follow-up, compared to parents in the control arm.~   "
158009|NCT01497873|"~     The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5~     days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung~     cancer.~   "
158010|NCT01497860|"~     The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink~     or slow the growth of pediatric low-grade gliomas that have either returned or are continuing~     to grow.~      Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in~     patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its~     therapeutic spectrum and decrease the neurotoxicity associated with related agents.~   "
158011|NCT01497847|"~     Purpose:~        -  identification of factors predisposing for Post-Infectious Irritable Bowel Syndrome~          (PI-IBS) development after an episode of traveler's diarrhea~        -  identification of systemic (serum) and local (biopsy) changes in infectious and~          immunological activity during infection and correlation with Irritable Bowel Syndrome~          (IBS) symptoms, persisting after traveler's diarrhea~      Design:~        -  4 study visits: before traveling, 2 weeks after traveling, 6 months after traveling, 12~          months after traveling~        -  at each study visit following investigations: blood collection, stool collection,~          questionnaires, rectal biopsy~   "
158012|NCT01497834|"~     The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032~     combination therapy in Japanese subjects.~   "
158013|NCT01497821|"~     This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in~     subjects with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or~     who have refractory disease following at least two prior therapies. The purpose of the study~     is to evaluate safety and pharmacokinetics (PK) of AMG 172, and also evaluate the objective~     response rate in patients with ccRCC receiving AMG 172. The study will be conducted in two~     Parts: Part 1 will explore doses of AMG 172 given every two weeks and every three weeks to~     determine the safety, tolerability and pharmacokinetics to establish a maximum tolerated dose~     (MTD), and Part 2 (dose expansion) will examine safety, tolerability, PK and overall response~     rate in subjects treated at the MTD established in Part 1 for either every two week or every~     three week dosing.~   "
158055|NCT01497262|"~     This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg~     in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data~     in Multiple Sclerosis (MS) patient population that closely resembles the clinical population~     seen in routine medical care.~   "
158015|NCT01497782|"~     With a worldwide proliferation of simulation centers, it is essential to explore the optimal~     setting for laparoscopic training and investigate different learning approaches, e.g. a~     self-directed approach. Therefore, the researchers investigated the following in a randomized~     controlled trial: the impact of instructor feedback vs. an independent, self-directed~     approach when training a complex operational task on a laparoscopic virtual reality~     simulator.~      The study hypothesis is that instructor feedback has a pivotal effect on surgical skills when~     training on a virtual reality simulator.~   "
158016|NCT01497769|"~     This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine~     MVA85A administered by the aerosol inhaled route and the intradermal route in healthy~     BCG-vaccinated adult subjects.~   "
158017|NCT01497756|"~     A group of midwives and obstetric nurses have been trained to use circumferential abdominal~     pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any~     use of a CAPP device will be monitored to identify complications.~   "
158018|NCT01497743|"~     Organs of the gastrointestinal tract include the mouth, throat, stomach, intestines, and~     anus. Patients with scleroderma often have GIT disorders. GIT disorders can be severely~     debilitating and even life-threatening. Some problems associated with GIT disorders may~     include heartburn, loss of voice or hoarseness, ulcers (open sores), difficulty swallowing,~     constipation, diarrhea, malabsorption (impaired absorption of nutrients from the GI tract),~     diminished peristalsis (decreased in the wavelike motion in the muscles of the intestines),~     and the inability to control your bowel movements.~      Probiotics are the good bacteria normally found in your digestive tract. Our group is~     looking at whether or not taking daily probiotics (lactobacillus) can help alleviate some of~     these symptoms in scleroderma patients that have GIT disorders.~   "
158019|NCT01497730|"~     This post-marketing investigation will evaluate the functional knee performance of Subjects~     who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one~     of four contemporary knee configurations from different manufacturers will be pooled to~     establish a contemporary dataset.~      The primary objective of this study is to evaluate the functional performance as measured by~     the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score~     (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year~     post-operation. This will be carried out for all four implant configurations. The final~     endpoint is a 2-year evaluation.~   "
158020|NCT01497717|"~     Hypothesis - Behcet's disease is a multisystemic chronic relapsing inflammatory disease,~     classified among the vasculitides. The clinical manifestations include mucocutaneous lesions,~     articular, ocular, vascular, gastrointestinal and/or central nervous system involvement.~      The aetiology of Behcet's disease is unknown, however. Experimental evidence suggests that~     TNF-α may play an important role in the pathogenesis of the disease.~      To date, case reports and small open-short term studies report the efficacy of anti-TNFα~     therapy (Infliximab and Etanercept), especially regarding ocular and mucocutaneous~     involvement in Behcet.~      There are no double blind long term studies on larger number of patients regarding the~     efficacy of anti-TNFα, especially Humira in healing arthritis +/- other manifestations of the~     disease.~   "
158021|NCT01497704|"~     This protocol will be divided into two parts: Part 1 will evaluate the safety and~     pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day~     continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an~     open-label administration of YN968D1 at the MTD or a maximum of 750 mg. All subjects in Part~     1 and Part 2 of this study will be permitted to continue therapy with only safety monitoring~     and bimonthly assessments for progression, if the product is well tolerated and the subject~     has stable disease or better. Up to 72 subjects will be enrolled in this clinical trial.~   "
158022|NCT01497691|"~     Previous investigations and anecdotal experience have shown safety and utility of Noninvasive~     Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the~     treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in~     children with respiratory insufficiency, emergency department and ICU stays may be shortened,~     and the need for more invasive and dangerous airway procedures may be decreased. This would~     result in a change in the standard of care for asthma treatment in emergency departments. The~     investigators hypothesis is that the use of this new NIPPV, in conjunction with current~     standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a~     more rapid improvement in patient ventilation, faster resolution of respiratory distress, and~     overall improved secondary outcomes.~   "
158023|NCT01497678|"~     The objective of the study is to assess mechanical strength and function in subjects~     undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of~     biologic scaffolds for the restoration of both mechanical strength and function in these~     subjects. This study will formally evaluate healing and return of function after an~     extracellular matrix device implantation in 40 male and female subjects participating at 4-5~     military sites who suffer from injury with loss of skeletal muscle tissue. The University of~     Pittsburgh under the Department of Plastic and Reconstructive Surgery is the Coordinating~     Center for this multi-site study.~   "
158024|NCT01497665|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in~     patients with brain metastases from non-small cell lung cancer (NSCLC).~   "
158025|NCT01497652|"~     The present pilot study is designed to assess the extent to which rasagiline may improve~     cognition in Parkinson's disease patients requiring dopaminergic therapy. The primary~     objective is to assess improvement in the Montreal Cognitive Assessment (MoCA) in patients~     who have been on rasagiline at 1mg daily for twelve weeks. The secondary objective is to~     assess changes in the SCOPA-COG, FAB, and UPDRS II & III at the end of week 14.~   "
158026|NCT01497639|"~     The aim of the study is to compare the efficacy and the safety profile of the newly~     introduced interleaving stimulation mode to those of the standard double monopolar~     stimulation mode during pallidal deep brain stimulation of primary generalized or segmental~     dystonia.~   "
158056|NCT01497249|"~     The objective of this study is to provide evidence for its fermentability of a dietary fiber~     and to collect information regarding potential health opportunities for glucose control as~     well as tolerability when being consumed over 7 days.~   "
158027|NCT01497626|"~     This study is for patients with an advanced type of cancer for which no curative treatment~     exists.~      The purpose of this study is to test the safety and efficacy of the combination of the study~     drugs, lapatinib and bortezomib. Lapatinib is a drug that targets two proteins important for~     the growth of cancer cells known as HER1 (EGFR) and HER2. By inhibiting these proteins,~     lapatinib can inhibit cancer cell growth and even lead to their death. Lapatinib is an oral~     pill given by mouth once every day. Lapatinib is approved by the FDA for patients with breast~     cancer.~      Bortezomib is a drug that targets a part of cancer cells known as the proteosome. By~     inhibiting the proteosome, bortezomib can inhibit cancer cell growth and even lead to their~     death. Bortezomib is given intravenously, once a week, 2 out of every 3 weeks. Bortezomib is~     approved by the FDA for patients with multiple myeloma and mantle cell lymphoma.~      This research is being done because it is not known if the combination of lapatinib and~     bortezomib will work better than lapatinib or bortezomib alone, although in the lab and in~     animal studies the combination of the two drugs was much more effective than either drug~     alone.~      As part of this study biopsies will be taken of patients' tumors before any treatment, after~     starting lapatinib alone, and after receiving both lapatinib and bortezomib. Investigators~     want to study what markers inside tumors may relate to how well these two medications work.~     These biopsies are required as part of the study.~   "
158028|NCT01497613|"~     Although technology offers great potential for enhancing the health and well-being of older~     adults, robust studies are needed to quantify the value of technology and further the~     investigators understanding of barriers to technology access among older adults and of~     strategies that are effective in removing these barriers. This cross-site randomized field~     trial will evaluate a simple to use Personalized Reminder Information and Social Management~     System (PRISM) designed to support social connectivity, memory, skill building and resource~     access for older adults. The PRISM system (PRISM C condition) will be compared to an notebook~     information control condition (PRISM B condition). The target population is older adults who~     live at home alone and are at risk for isolation. The goal of the study is to gather~     systematic evidence about the value of technology for older adults and to identify factors~     that affect use and usability, acceptance and technology adoption. The investigators will~     also gather longitudinal data on the benefits of the system. Participants aged 65 - 85 years~     (100 per site) will be randomly assigned following baseline assessment to one of two~     conditions: PRISM C condition where participants receive the technology system or the PRISM B~     condition only control where participants receive a notebook that includes information~     similar to that provided in PRISM C (e.g., resource guide). The categories of information~     provided in the notebook is similar to the features provided on the system. Participants will~     include males and females who do not have a home computer and who have limited Internet~     experience. The intervention period is 12 months. A battery of measures that includes~     demographic information, attitudes towards technology (including computer self-efficacy and~     computer comfort), technology, computer and Internet experience, functional independence and~     well-being, emotional well-being social support/isolation, and quality of life will be~     administered at baseline, and 6 and 12 months post randomization. In addition, the~     investigators will assess cognitive abilities at baseline and twelve months. The~     investigators will also gather data regarding technology use and social interactions via a~     brief telephone interview at 18 months post randomization.~   "
158029|NCT01497600|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2~     diabetes of various race and ethnicity.~   "
158030|NCT01497587|"~     This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of~     insulin detemir in healthy Taiwanese subjects.~   "
158031|NCT01497574|"~     This trial is conducted in Europe. The aim of this trial is to compare the within-subject~     variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in~     children and adolescents with type 1 diabetes.~   "
158032|NCT01497561|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in~     subjects with type 2 diabetes.~   "
158033|NCT01497548|"~     Primary Objective To determine the efficacy of Methylphenidate as add on therapy to~     mirtazapine in the treatment of depression in cancer patients under palliative care~     Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early~     reduction in (Montgomery Asberg Depression Rating Scale) MADRS between baseline and Day 3.~      Secondary Objective~        1. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in the~          treatment of anxiety in cancer patients under palliative care.~           Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant~          early reduction in anxiety score of HADS than Mirtazepine alone treated subjects between~          baseline and Day 3.~        2. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in~          reducing distress in cancer patients under palliative care.~           Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant~          early reduction in distress score of distress thermometer than Mirtazepine alone treated~          subjects between baseline and Day 3.~        3. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in~          improving function in cancer patients under palliative care.~           Hypothesis Methyphenidate add on to mirtazapine treated subjects will show increase in~          the (Eastern Cooperation Group performance status) ECOG score than Mirtazepine alone~          treated subjects between baseline and Day 3~        4. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in~          reducing somatic complaints in cancer patients under palliative care.~      Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early~     reduction in the score of Numeric Rating Scale (NRS) for Pain and Visual Analogue Scale (VAS)~     for Fatigue than Mirtazapine alone treated subjects between baseline and Day 3.~   "
158034|NCT01497535|"~     This trial is conducted in Europe. The aim of this trial is to compare the within-subject~     variability of insulin detemir to that of another basal insulin analogue, insulin glargine in~     healthy volunteers.~   "
158035|NCT01497522|"~     The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as~     an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted~     to support registration of the fixed-dose combination of vildagliptin and metformin for the~     treatment of Type 2 diabetes mellitus (T2DM) in Japan.~   "
158036|NCT01497509|"~     Although intrapartum epidural analgesia is frequently implicated in adverse breast-feeding~     outcomes, many previous studies feature major design limitations that preclude widespread~     applicability of findings. Some fail to control for the precise pharmacologic composition of~     the epidural infusion, including whether or not an opioid, such as fentanyl, is even used at~     all in addition to local anesthetic or whether a combined spinal/epidural or purely epidural~     technique is used. The drugs used in epidural infusions not only have different mechanisms of~     action and lipophilicities but are also transferred across the placenta in varying~     proportions, with one study identifying an umbilical vein/maternal vein ratio of 0.94 for~     epidural fentanyl and 0.30 for bupivacaine, and another finding significantly different~     umbilical cord fentanyl concentrations among neonates whose mothers' epidural infusions~     contained >150 micrograms fentanyl, <150 micrograms, or none at all. It is also possible that~     the same total dose of epidural fentanyl could affect neonates differently depending upon the~     time course over which it was administered - namely, whether fentanyl is included in both the~     initial epidural bolus and the subsequent infusion or solely in the infusion. In two studies,~     mean umbilical vein concentrations of fentanyl did not correlate with total epidural infusion~     time, but both of these featured sample sizes fewer than 30, necessitating further research.~     Another limitation of some previous studies is defining success solely as the time to~     cessation of breast-feeding. Questionnaires mailed to mothers months or even years postpartum~     may generate unreliable data. If epidural medications truly mediate some physiologic effect~     upon breast-feeding, then the optimal study period is immediately post-delivery, specifically~     before the drugs are cleared from the maternal and neonatal circulations. After hospital~     discharge, many new factors - such as a mother's need to return to work or lack of social~     support - begin to confound the picture of breast-feeding success. Full-time employment~     outside the home has been significantly associated with decreased likelihood of~     breast-feeding at 6 months postpartum. Some studies also fail to control for intent to~     breast-feed at the time of hospital admission, number of infants previously breast-fed, or~     labor duration. Failure to account for oxytocin augmentation of labor is also problematic, as~     intravenous intrapartum oxytocin infusion has been shown to decrease a woman's endogenous~     serum oxytocin concentration on the second day postpartum in a dose-dependent fashion, which~     can subsequently impair milk release and, thus, decrease breast-feeding success.~      Epidural analgesia may worsen breast-feeding outcomes by attenuating neonatal exhibition of~     neurobehaviors tied to feeding, such as sucking, rooting, and swallowing, during the~     immediate postpartum period. This critical period is when mother and baby make their first~     attempts at breast-feeding and set a precedent for subsequent interactions. Neonatal feeding~     behavior in the early postpartum period is an important predictor of long-term breast-feeding~     success; those babies who feed most vigorously during their first days of life are~     significantly more likely to still be breast-feeding at 3 or 6 months than those who exhibit~     any lesser degree of breast-feeding enthusiasm. Radzyminski et al. found no significant~     dose-response relationship for either epidural bupivacaine or fentanyl regarding neonatal~     feeding behaviors, and Porter et al. found no significant effect of epidural fentanyl, mean~     dose 184 micrograms, upon neonatal APGAR scores, incidence of respiratory depression, or NACS~     scores (Neurologic and Adaptive Capacity Scores) at 2 or 24 hours post-delivery. Beilin et~     al. found that neonatal NACS scores were significantly lower when mothers' epidural infusions~     contained greater than 150 micrograms total epidural fentanyl than when they contained only~     bupivacaine.~      In this randomized, controlled, double-blinded study, we investigate whether intrapartum~     epidural fentanyl significantly decreases the likelihood of breast-feeding at hospital~     discharge and increases the incidence of neonatal deficits in latching on to the breast and~     audibly swallowing during the first three hours of life. We hypothesize that these effects~     will be dose-dependent but will have no relation to the time course over which the epidural~     fentanyl is administered. We also investigate whether oxytocin augmentation of labor and~     decreased amount of skin-to-skin contact during the first hour of life are associated with~     significantly decreased breast-feeding rates at hospital discharge.~   "
158037|NCT01497496|"~     The main purpose of this study is to see if the combination of ofatumumab with high dose~     methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help~     people with relapsed or refractory CLL/SLL get rid of their CLL/SLL for a long period of~     time. Researchers also want to find out if the combination of ofatumumab with~     methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe~     and tolerable.~   "
158038|NCT01497483|"~     This study will address the following question: Does cyclosporine affect the pharmacokinetics~     of pravastatin in healthy volunteers? Studies have shown that cyclosporine inhibits the~     organic anion transporter required for pravastatin transport into the liver, thus increasing~     pravastatin levels in the blood. The investigators hypothesize that this inhibition will vary~     among people based on genetic differences. This knowledge is important to help develop safer~     and more effective drug therapy with reduced side effects.~   "
158039|NCT01497470|"~     The primary goal of this study is to determine if custirsen has an effect on the way the body~     distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study~     will also evaluate if custirsen influences the way the body distributes and gets rid of~     carboplatin (another standard administered chemotherapy) and will measure custirsen blood~     levels in this cancer population. Finally, the study will evaluate the safety and~     tolerability of adding custirsen to the standard paclitaxel/carboplatin chemotherapy.~   "
158040|NCT01497457|"~     MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch~     of Douglas. The investigators think that the localization of the rectal tumor in function of~     this anatomic mark could be decisive for pre-operative assessment.~   "
160803|NCT01461252|"~     This study will evaluate the safety and efficacy of cryoablation therapy combined with~     radiation therapy for the relief of pain associated with metastatic bone tumors.~   "
158041|NCT01497444|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as hypoxia-activated prodrug TH-302, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     sorafenib tosylate together with hypoxia-activated prodrug TH-302 may kill more tumor cells.~      PURPOSE: This phase I/II trial studies the side effects and best dose of giving sorafenib~     tosylate together with hypoxia-activated prodrug TH-302 and to see how well they work in~     treating patients with advanced kidney cancer or liver cancer that cannot be removed by~     surgery.~   "
158042|NCT01497431|"~     This randomized phase I trial studies the side effects and the best dose of~     Se-methyl-seleno-L-cysteine or selenomethionine in preventing prostate cancer in healthy~     participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The~     use of Se-methyl-seleno-L-cysteine or selenomethionine, two different types of selenium~     compounds, may prevent prostate cancer from forming.~   "
158043|NCT01497418|"~     Collect and evaluate the long term safety data.~   "
158044|NCT01497405|"~     This study compares the effects of standard HIV test, treat and retain (TTR) practices with~     TTR plus a woman-focused enhanced strategy--Women's Health CoOp (WHC+) intervention)~     targeting hard-to-reach and vulnerable alcohol and other drug (AOD)-using women to determine~     if the WHC+ intervention is more efficacious than TTR alone in reducing HIV risk behavior.~     Additionally, the study will determine whether HIV positive women in the WHC+ arm are more~     likely to follow through with referrals for further medical evaluation and linkages to HIV~     treatment and other care than women in the TTR arm.~   "
158045|NCT01497392|"~     This phase I trial is studying the side effects and best dose of dovitinib lactate when given~     together with gemcitabine hydrochloride and capecitabine in treating patients with advanced~     or metastatic solid tumors or advanced pancreatic cancer. Dovitinib lactate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving dovitinib lactate together with combination chemotherapy may kill more tumor~     cells~   "
158046|NCT01497379|"~     Patients who are legally blind, caused by retinal degeneration of photoreceptor rods & cones~     (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.~   "
158047|NCT01497366|"~     This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in~     combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon~     (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV)~     genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks~     after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if~     non-inferiority was demonstrated, the study was then allowed to test for superiority.~   "
158048|NCT01497353|"~     To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after~     birth) as an indirect measure of the volume of placental transfusion in a group of healthy~     and fullterm newborns, placed at the level of the introitus versus another group placed on~     the abdomen of the mother.~   "
158049|NCT01497340|"~     To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after~     birth) as an indirect measure of the volume of placental transfusion in a group of healthy~     and fullterm newborns, placed at the level of the introitus versus another group placed on~     the abdomen of the mother.~   "
158050|NCT01497327|"~     This study will be conducted in Hepatitis C positive patients to determine whether the~     pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with~     normal hepatic function, which may allow inclusion of patients with cirrhosis and varying~     degrees of hepatic dysfunction in future clinical studies.~   "
158051|NCT01497314|"~     The purpose of this study is to show that a low lactose milk-based infant formula supports~     normal growth in healthy term infants.~   "
158052|NCT01497301|"~     Much evidence exists that new, more effective methods of delivering care to diabetics are~     necessary. In our current system of delivering care, diabetes care is often done in the~     context of multiple other issues addressed during a regular office visit. Providers often~     lack the time to properly educate patients on diabetes self management topics. This project~     hopes to show that group visits can improve clinical outcomes, patient satisfaction, provider~     satisfaction, and patient's self management knowledge, while decreasing cost. This group~     visit method can make care more patient-centered and team based which is in alignment with~     our organization's goal of becoming a true patient centered medical home. If successful, this~     could expand to our other family medicine clinic sites and provide a valuable learning~     opportunity for the family medicine residents at OHSU.~      The investigators will first identify newly diagnosed diabetics (diagnosed within the last 12~     months) at the South Waterfront and Gabriel Park family medicine clinics using EPIC. The~     investigators will invite those diabetics identified from the South Waterfront clinic to~     participate in 6 group visits that will follow a curriculum that the investigators created~     based on the National Standards for Diabetes Self Management Education and the ACP Diabetes~     Care Guide. This curriculum will address basic pathophysiology of diabetes, the ABCs to~     Better Diabetic Care as defined by the ACP Diabetes Care Guide, setting goals, nutrition,~     exercise, diabetic medications, and complications of diabetes. This intervention group will~     be compared to a control cohort identified at the Gabriel Park clinic that will continue to~     receive standard diabetes care from their primary physician. The investigators will look at~     and compare clinical outcomes (Hemoglobin A1C, blood pressure (BP), and LDL cholesterol~     levels), adherence to recommended preventive measures for diabetics (foot exams, eye exams,~     yearly microalbumin, and immunizations), patient and provider satisfaction, as well as cost.~     Cost data will be collected using EPIC to look at the costs involved in group visits compared~     to the cost of delivering diabetic care through the standard individual medical appointment.~     The investigators may also use EPIC to look at utilization of specialty services, emergency~     room visits, and inpatient admissions and compared utilization across groups.~   "
158053|NCT01497288|"~     The overall clinical trial objective is to gain information about the Pharmacokinetics (PK)~     of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male~     and female subjects are planned to be randomized in the trial. Subjects will be randomized to~     one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose INFS,~     400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will~     be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic~     samplings will be conducted.~   "
158054|NCT01497275|"~     The purpose of this study is to evaluate the effects (good and bad) of the combination of~     ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory~     mantle cell lymphoma.~      Zevalin is a monoclonal antibody that is combined with a radioactive substance and given with~     another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer cells~     and releasing radiation to damage those cells. Both Zevalin and Rituxan are given in this~     study, along with Velcade.~   "
158061|NCT01497184|"~     The goal of this clinical research study is to learn if researchers can successfully and~     safely give HSCT patients an infusion of white blood cells (called T-cells) that have been~     genetically changed. The process of changing the DNA (the genetic material in cells) of these~     T-cells is called gene transfer. Researchers want to learn if these genetically-changed~     T-cells are effective in attacking cancer cells in patients with advanced B-cell lymphoma or~     leukemia, after they have received standard allogeneic HSCT. Researchers want to find out the~     highest dose of these special T-cells that can be given safely to leukemia and lymphoma~     patients. Researchers also want to learn how long the changed T-cells stay in your body, and~     if adding them to standard transplant can improve how you respond to treatment.~   "
158062|NCT01497171|"~     This study is designed to compare the safety and efficacy of a commercially available mesh~     kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair~     surgery.~   "
158063|NCT01497158|"~     This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a~     novel approach of adoption of home smoking restrictions. This will be done by providing the~     cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. The~     intent is to identify an intervention strategy(ies) to reduce ETS exposure.~   "
158064|NCT01497145|"~     This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to~     Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects~     with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.~   "
158065|NCT01497132|"~     The purpose of this study is to evaluate if treatment with vitamin D increase beta cell~     function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes~     mellitus type 2.~   "
158066|NCT01497119|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.~   "
158067|NCT01497106|"~     This study is being done to understand the effects of calorie restriction and weight loss on~     muscle protein metabolism in adult men and women.~   "
158068|NCT01497093|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of pomalidomide in~     combination with bortezomib and low-dose dexamethasone in subjects with relapsed or~     refractory multiple myeloma~   "
158069|NCT01497080|"~     The Problem Distal radius fractures (DRF) are common and result in a variable amount of~     disability. The investigators have completed considerable work in developing tools that~     measure impairment and disability after DRF . The investigators initial studies indicate that~     the associated disablement process is multifactorial and variable with only 25% of the~     resultant disability predicted by baseline patient and injury characteristics. The~     investigators see DRF as a signal event where some people are at-risk of transitioning from~     an active lifestyle to inactivity and subsequent health risks. The investigators recent data~     confirms variable participation following a DRF. The traditional focus in~     orthopedic/rehabilitative approaches to DRF fracture management has been localized to the~     wrist, largely ignoring this potential transition and its health impacts. The investigators~     will initiate a line of investigation that will profile the at-risk older adult who presents~     with a DRF with the ultimate goal of accurate identification and prevention of adverse~     activity transitions (active to inactive). In this study the investigators will identify the~     extent of the problem by quantifying changes in activity/participation and its short-term~     health impacts. The investigators will also identify the risk factors present at time of~     injury that predict a loss of mobility/activity/participation. This work has the potential to~     identify tools and/or clinical prediction rules that identify at-risk individuals at a~     critical time where early intervention might most easily prevent adverse outcomes associated~     with inactivity.~   "
158070|NCT01497054|"~     The purpose of this study is to determine if B type natriuretic peptide (BNP) levels can be~     used to predict a hemodynamically significant patent ductus arteriosus (PDA). This peptide is~     produced by the ventricles in the heart when they are under stress, such as when a ductus~     remains open. If we can use a simple and inexpensive blood test to determine whether a PDA~     needs to be treated, we can potentially treat infants sooner than if they needed to wait for~     the availability of a cardiologist to perform an echocardiogram. This might decrease some of~     the deleterious effects of PDAs on the preterm infant such as bronchopulmonary dysplasia,~     necrotizing enterocolitis, renal hypoperfusion, and pulmonary hemorrhage. In a situation~     where follow up echocardiogram after a course of medical therapy shows persistent PDA, this~     test may help to decide whether this baby needs further treatment, either medical or~     surgical.~   "
158071|NCT01497041|"~     1. Goals~           The primary goal of this phase II trial is to:~           evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in~          patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as~          second-line treatment~           Secondary goals are to:~           evaluate the treatment-related toxicities of this combination, investigate~          progression-free survival (PFS) and overall survival (OS) in this population~        2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase~          II trial according to the two stage testing design by Simon two-stage testing procedure~   "
158072|NCT01497028|"~     This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable~     Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in~     bariatric surgical outcomes~        -  Weight Loss~        -  Co-morbid disease resolution~   "
158073|NCT01497015|"~     This is a randomized controlled trial to evaluate the ACTIVE memory training intervention and~     ACTIVE speed of processing training to waitlist, no-contact control conditions. Specific aims~     and hypotheses are:~      Aim 1: Evaluate the acceptability and usefulness of the ACTIVE memory intervention among~     Breast Cancer Survivors (BCS).~      Hypothesis 1: BCS assigned to the memory intervention arm will perceive the intervention as~     more acceptable and useful than BCS assigned to the attention control condition.~      Aim 2: Establish preliminary efficacy of the ACTIVE memory training intervention relative to~     the attention control and no-contact control conditions.~      Hypothesis 2: Memory training will result in greater memory enhancement immediately post and~     2-months post-intervention relative to attention control or no-contact control conditions.~   "
158074|NCT01497002|"~     Improvement of the treatment-results in elderly patients with acute myeloid leukemia through~     intensification of consolidation chemotherapy and/or allografting as consolidative~     immunotherapy~   "
158075|NCT01496989|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of~     multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human~     IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in~     low-risk for HIV-uninfected healthy adults.~   "
158076|NCT01496976|"~     The main purpose of this study is to see if ofatumumab with methylprednisolone followed by~     additional treatment with ofatumumab and lenalidomide can help people with Chronic~     Lymphocytic Leukemia (CLL) get rid of their CLL for a long period of time. Researchers also~     want to find out if the combination of ofatumumab with methylprednisolone followed by~     additional treatment with ofatumumab and lenalidomide is safe and tolerable.~   "
158077|NCT01496963|"~     This is a multicenter observational case-control analysis lasting 12 months aimed at~     determining the prevalence of pulmonary hypertension (PAH) in patients with Thalassemia Major~     and Intermedia. The patients will be followed, treated and examined according to the best~     standard clinical practice dictated by the Italian Society for the study of~     Hemoglobinopathies (SITE), Thalassemia International Federation (TIF)and the Task Force for~     Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC);~     European Respiratory Society (ERS); International Society of Heart and Lung Transplantation~     (ISHLT) guidelines.~   "
158078|NCT01496950|"~     The purpose of this study is to determine whether active repetitive transcranial magnetic~     stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive~     treatment of chronic migraine, compared to placebo repetitive transcranial magnetic~     stimulation.~   "
158079|NCT01496937|"~     The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974~     present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy~     subjects.~      Furthermore, during the course of the study, safety and tolerability as well as the effects~     of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be~     characterized compared to placebo.~   "
158080|NCT01496924|"~     There is an association between increased risk of oropharyngeal dysphagia and artificial~     ventilation through endotracheal tube, followed by tracheostomy. The aim of the present study~     is to analyze the outcomes of an early swallowing rehabilitation program of dysphagic~     tracheostomized patients under mechanical ventilation at the intensive care unit.~   "
158081|NCT01496911|"~     Antihistamines are commonly used and currently levocetirizine is most frequently prescribed~     in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems,~     especially to open tubal passage. However, the effects of these drugs on cognitive~     performance have not been investigated during diving.The objective of this study is to~     investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and~     psychomotor functioning during controlled simulated diving in a hyperbaric chamber in~     professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that~     hydroxyzine will produce significant impairment, and that the magnitude of impairment is~     related to hyperbaric pressure.~   "
158082|NCT01496898|"~     The goal of this study is to examine changes in the bacterial ecology and inflammatory~     markers of the female genital tract with levonorgestrel intrauterine device placement.~      The specific research objectives of this project include:~        1. Characterization of vaginal, cervical and uterine bacterial species and communities~          prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples~          will be collected up to 1 week before and 2 months after IUD insertion.~        2. Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to~          and after LNG IUD placement using human RNA microarray analysis. Samples will be~          analyzed from up to one day before and three weeks after IUD insertion.~        3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.~   "
158083|NCT01496885|"~     The purpose of this study is to evaluate the utility of the S-STREAM as an instrument to~     assess motor function in subjects who have experienced a nonhemorrhagic ischemic stroke.~   "
158084|NCT01496872|"~     Two prominent osteopathic physician researchers have studied cranial somatic dysfunction in~     newborns. Dr Viola Frymann published a paper in 1966 on the presence of somatic dysfunction~     involving 1250 infants. Dr. Jane Carreiro evaluated 1600 newborns in 1993 for cranial somatic~     dysfunction. This observational study is intended to continue their work in exploring the~     presence of cranial somatic dysfunction in newborns. The hypothesis is that there is an~     increased incidence of somatic dysfunction in newborns birthed by primigravid women and in~     newborns who experienced a longer second stage of labor.~   "
158085|NCT01496859|"~     The Baska mask is a new supraglottic airway device . The investigators would like to assess~     its performance in setting in which the current standard - LMA device - is being used.~   "
158086|NCT01496846|"~     The purpose of this trial is to study the ability of a frequently used dental anesthetic~     (articaine) to achieve complete numbness of a diseased tooth with the most commonly used~     injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this technique~     fails, a commonly used supplemental (SUP) technique with one of two possible dental~     anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of~     complete numbness between the two anesthetics.~      Standardized administration of anesthesia is provided by controlled delivery using Midwest~     Comfort Control Syringe.~      The investigators hypothesize that supplemental infiltration anesthesia with articaine will~     give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular~     molars with irreversible pulpits.~      This study consisted of two periods of patient enrollment, treatment and data collection:~     Part I: 101 subjects; Part II: 100 subjects.~   "
158087|NCT01496833|"~     The purpose of this study is to investigate the short to mid term efficacy and safety of a~     newly-developed branched stent graft in patients who had complex aortic lesions, such as~     ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde~     Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.~   "
158118|NCT01496430|"~     The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as~     well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in~     stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was~     inadequate on metformin alone.~   "
161538|NCT01451619|"~     This study will assess the effect of MK-0524 relative to placebo, on signs and symptoms of~     rosacea and to determine the safety and tolerability profile of MK-0524 in participants with~     rosacea.~   "
158088|NCT01496820|"~     The effects of chitosan on blood glucose levels have been contradicting. Hypoglycemic effects~     of high molecular weight chitosan are related to diabetic models with hypoinsulinemia but~     have shown little effect on the blood glucose levels in hyperinsulinemia related diabetic~     models. Based on previous reports, high molecular weight chitosan either directly or~     indirectly related to insulin secretion in pancreas but has little effect on insulin~     resistance. In the present study, the effect of GO2KA1 (low molecular weight chitosan~     oligosaccharide) on blood glucose levels in Korean pre-diabetic adults, will be evaluated.~     The changes in postprandial blood glucose levels will be investigated in subjects with~     impaired fasting glucose or glucose tolerance.~   "
158089|NCT01496807|"~     The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when~     it is given to people who are also receiving a drug called Sylatron. Investigators also wish~     to find out whether the addition of Yervoy increases the chance that Sylatron will cause a~     rise in the level of antibodies in the patient's blood that recognize their own tissues,~     known as autoimmune antibodies. Investigators also want to find out how likely it is that~     their tumor will shrink.~   "
158090|NCT01496794|"~     The intent of this surveillance study will be to obtain written permission from patients with~     bacterial endophthalmitis in order to compare sterilization rates of their cultured bacterial~     isolates to standard therapy (vancomycin and ceftazidime) versus combination therapy with~     vancomycin, ceftazidime, and moxifloxacin.~      Research hypothesis:~        1. Cultured bacterial isolates will demonstrate faster in vitro sterilization rates with~          combination treatment (vancomycin, ceftazidime, and moxifloxacin) compared to standard~          therapy with vancomycin and ceftazidime.~        2. Longitudinal analysis of resistance patterns of cultured isolates will show increasing~          rates of multi-antibiotic resistance.~   "
158091|NCT01496781|"~     Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment~     techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common~     complication following EMR. Several endoscopic hemostasis methods are currently in use~     including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new~     hemostasis material was previously used for surgical hemostasis, but the therapeutic effect~     and safety in endoscopic application remains unknown. This randomized controlled study has~     been designed to compare PAPH with metallic hemoclip in their hemostatic effect of~     intra-procedure bleeding control and rebleeding prevention during and after EMR.~   "
158092|NCT01496768|"~     This study aims to evaluate the effects of chronic leucine supplemetion on glucose~     homeostasis, body compositin, muscle mass and strength of healthy and young subjects~   "
158093|NCT01496755|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety and~     pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomized in cohorts to~     receive either single/multiple doses of RG7667 intravenously or placebo. Anticipated time on~     study treatment is up to 57 days with a 12-week follow-up.~   "
158094|NCT01496742|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone~     chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV~     non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive~     4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum~     (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day~     cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum~     (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day~     cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy~     with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or~     pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is~     until disease progression or unacceptable toxicity occurs.~   "
158095|NCT01496729|"~     Postoperative pain is a major problem in patients who either donate a kidney or undergo~     kidney transplantation. This pain is commonly treated with opioids, which can cause several~     side effects, ranging from pruritus, impaired vigilance, and most concerning to severe~     respiratory depression. This can be aggravated in the recipient by accumulation of opioid~     metabolites secondary to renal impairment and secretion.~      Several studies have shown an opioid sparing effect of a transversus abdominis plane (TAP)~     block after surgery in the lower abdomen. In the proposed study, we plan to compare the~     impact of an ultrasound guided single shot transversus abdominis plane (TAP) block versus a~     ultrasound guided sham block with normal saline (placebo) on postoperative pain scores,~     postoperative opioid consumption, as well as patient's satisfaction.~      The investigators hypothesize, that patients who receive a TAP block will have lower~     postoperative pain scores, lower postoperative opioid consumption as well as higher~     satisfaction scores.~   "
158096|NCT01496716|"~     The purpose of this study is to investigate whether there is a correlation between hip~     arthroplasty patients' preoperative weight and the patients quality of life and the clinical~     effect one year postoperatively.~   "
158097|NCT01496703|"~     Mycophenolate mofetil (MMF) decreases the risk of acute rejection and is associated with~     improved graft survival in renal transplant recipients. However, MMF-related side effects~     often necessitate dose reduction which may expose transplant recipients to a higher risk of~     acute rejection and graft loss. This study's aim was to examine the reasons for MMF dose~     reduction during the first year after kidney transplantation and its impact on acute~     rejection, overall and death-censored graft loss. Methods: Retrospective electronic file~     based analysis of all patients who underwent a single kidney transplantation in our center~     between 1996 and 2007 and were treated with MMF as part of their initial maintenance~     immunosuppressive protocol (n=749).~   "
158098|NCT01496690|"~     The PACS study aims to investigate the efficacy and tolerability of pregabalin for~     schizophrenic patients that suffer from comorbid anxiety.~      The study design is an 8 week flexible dosage, randomized placebo controlled.~      The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Patients~     are recruited from outpatient clinics from entire Denmark.~   "
158099|NCT01496677|"~     To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger~     control subjects~   "
161697|NCT01449526|"~     The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel~     contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft~     contact lens wearers.~   "
158100|NCT01496664|"~     The purpose of the registry is to assess results of combined operative and catheter based~     (hybrid procedure) treatment of patients with significant coronary artery disease using~     essential clinical and angiographic parameters.~      Based on existing literature we expect the results of coronary artery bypass grafting of the~     anterior descendent coronary artery (LAD), segment 1 and 2, using the so-called mammary~     artery graft, to be superior to stent treatment of the same artery.~      At the same time a catheter based intervention using balloon, bare metal stents (BMS) or drug~     eluting stents (DES) seems to be a better treatment that a saphenous vein graft for other~     coronary arteries than the LAD. I.e. the right coronary artery (RCA) and the left circumflex~     coronary artery (CX).~      Therefore, we expect a combination of the mentioned surgical and catheter based techniques to~     be a better treatment than bypass operation or catheter based intervention alone.~   "
158101|NCT01496651|"~     Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty~     in the Treatment of Unprotected Left Main Stenosis.~      In a clinical, randomized, 5-year follow-up study to compare essential clinical outcome~     parameters in patients with unprotected left main (LMCA) disease, treated with coronary~     artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) using drug~     eluting stents (DES).~      DES-PCI of unprotected LMCA disease is non-inferior to CABG concerning the 2-year rate of~     death, myocardial infarction, stroke or new revascularization and concerning the 5-year rate~     of death.~   "
158102|NCT01496638|"~     How should coronary artery stenoses with significant side branch be stented?~      A strategy of stenting both main vessel and side branch compared to a strategy of stenting~     the main vessel and only stenting the side branch if necessary.~      The 2-stent strategy is superior to the 1-stent strategy regarding occurrence of cardiac~     death, non-procedure related myocardial infarction and re-revascularization with percutaneous~     coronary intervention (PCI) or coronary artery bypass grafting (CABG).~   "
158103|NCT01496625|"~     Background:~      - To understand diseases of the retina and the eye, information is needed about people with~     and without such diseases. Researchers want to study these people and follow them over time.~     They also want to study body tissues and blood to understand the nature of eye disease.~     Studying genes, cells, and tissues may help them understand why some people get eye problems~     and others do not, or why some people respond to treatment while others do not. Researchers~     want to collect physical samples and personal data to develop a National Eye Institute~     database.~      Objectives:~      - To collect health information and blood and tissue samples from people with and without eye~     diseases, to be used in research studies.~      Eligibility:~        -  Individuals of any age with different types of eye disease.~        -  Healthy volunteers with no history of eye disease.~      Design:~        -  Participants may be recruited from National Eye Institute studies or may be referred~          from other sources.~        -  Participants will be screened with a physical exam and medical history. They will also~          have a full eye exam. Questions will be asked about family medical history, especially~          about eye disease.~        -  Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and~          urine, may be collected as needed. Adult participants may also provide a skin sample.~        -  Tissue or fluid from eye collected as part of eye care or treatment may also be added to~          the database.~        -  No treatment will be provided as part of this study.~   "
158104|NCT01496612|"~     Background:~      - Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies~     suggest that buspirone might act on parts of the brain that can increase certain levels of~     brain activity. Increasing this brain activity may help decrease epileptic seizures that come~     from certain parts of the brain. Researchers want to see if buspirone can reduce seizure~     frequency in people with seizures who are already taking antiseizure medication.~      Objectives:~      - To test whether buspirone can reduce the frequency of seizures in people whose seizures~     seem to start from one part of the brain.~      Eligibility:~        -  Individuals between 18 and 65 years of age who have seizures coming from one or more~          places in the brain.~        -  Participants must have tried at least two different antiseizure medications. They must~          also have had at least three seizures during a 1-month observation period while on~          current medicines.~      Design:~        -  Participants will have a screening visit with a physical exam and medical history.~          Participants will complete mood and memory testing scales. Blood, urine, and saliva~          samples will be collected.~        -  Participants will have a magnetic resonance imaging scan to evaluate brain structures~          that relate to epilepsy. They will also have a positron emission tomography scan to look~          at parts of the brain that are affected by buspirone.~        -  Participants will start taking a study drug (either buspirone or placebo) twice daily.~          They will keep a calendar of seizures and record any side effects. Treatment will be~          monitored with clinic visits and blood samples.~        -  After 12 weeks on the study drug, participants will gradually stop taking either the~          placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks.~        -  After 2 weeks, participants will start taking a study drug that is the opposite of the~          one they had before. They will keep a calendar of seizures and record any side effects.~          Treatment will be monitored with clinic visits and blood samples.~        -  After 12 weeks on the study drug, participants will gradually stop taking either the~          placebo or buspirone.~        -  Participants will have a final followup visit with additional blood tests, mood and~          memory testing scales and imaging studies.~   "
158105|NCT01496599|"~     Background:~      - Parkinson s disease (PD) causes slow movement, stiffness, and tremor. It results from the~     loss of a brain chemical called dopamine. PD gets worse over time, but researchers do not~     fully understand why the brain cells that produce dopamine stop working or die in people with~     PD. This study will use different ways of imaging the brain and brain chemicals to look at~     PD. It will compare brain imaging in people who definitely have PD to people who might have~     PD and to people without signs of PD. It will provide more information how the brain in~     people with PD changes over time.~      Objectives:~      - To understand the changes that occur in the brains of people with Parkinson s disease.~      Eligibility:~        -  Individuals at least 18 years of age who have definite or possible Parkinson s disease.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will have a screening visit with a physical exam and medical history. Blood~          and urine samples will be collected.~        -  Participants will visit the National Institutes of Health Clinical Center once a year~          for 9 years. There will be 10 total visits. Most visits will last 5 to 6 hours a day for~          2 to 3 days. Some or all of the following tests will be performed at each visit:~        -  Transcranial sonography, which uses sound waves to take pictures of the brain.~        -  Magnetic resonance imaging to take pictures of the brain. Some of these tests will be~          done at rest. Others will require participants to perform an activity during the scan.~        -  Dopamine imaging studies to show how the brain uses the chemical dopamine.~        -  Magnetoencephaolgraphy to show brain activity.~        -  Electromyography to show muscle activity.~        -  Medication withdrawal for 12 hours overnight for people taking PD medications. This may~          be done before some scans. Participants who feel unwell when they stop taking~          medications will be allowed to start taking them again.~        -  Participants will continue with the followup visits until the end of the study.~   "
158114|NCT01496482|"~     Purpose:~      To establish whether there is a correlation between dry eye symptoms, age and gender, a~     difference in symptom intensity in different times of the day, which test (Schirmer or TBUT)~     better correlates with dry eye symptoms, whether it is possible to reliably use cheap, easy~     to use hygrometer in everyday clinical setting, and finally whether there is statistically~     significant correlation between applied tests (TBUT, Schirmer and evaporimetry).~      Methods:~      Subjects: 45 in group without dry eye related symptoms, and 45 in group with symptoms.~      Examination included structured case history (questionnaire), slit lamp examination with~     fluorescein staining, periocular evaporimetry, TBUT test and Schirmer test.~   "
158115|NCT01496469|"~     The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared~     to placebo on lowering ambulatory 24-hour mean blood pressure of participants with~     hypertension and hyperuricemia (not associated with gout).~   "
158106|NCT01496586|"~     Background:~      - Many service members have reported feeling tired, a loss of motivation, mood changes, and~     problems working with others after they have a concussion during deployment. These problems~     may lead to problems with their job and relationships. This study hopes to figure out what~     parts of the brain may be affected in people with these problems after a concussion.~      Objectives:~      - To learn more about the problems that may occur after service members have a concussion~     during deployment and return home.~      Eligibility:~        -  Service members or veterans between 18 and 40 years of age who have had a mild traumatic~          brain injury (concussion) in the past 6 months.~        -  Companions (at least 18 years of age) of the service members will also be included in~          this study. Companions will have interacted with the service member at least 1 hour a~          week since deployment.~      Design:~        -  Service members will have 1 week of tests at the National Institutes of Health Clinical~          Center. Companions will have 2 days of tests at the Center.~        -  Each day, service members will have 4 or 8 hours of tests. Tests will include a medical~          history and physical exam, neuropsychological tests and imaging studies. The tests will~          ask about fatigue, stress, mood, pain, daily activities, and family support. The imaging~          studies will measure brain function at rest and during activity.~        -  Companions will have a medical history and physical exam. They will also complete~          several questionnaires about themselves as well as the service member/veteran. The tests~          will ask about fatigue, stress, mood, pain, daily activities, and family support.~   "
158107|NCT01496573|"~     This research trial studies biomarkers in tumor tissue samples from younger patients with~     rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer~   "
158108|NCT01496560|"~     The aim of the study is to determine what precolonoscopic measures can be correlated to pain~     during colonoscopy~   "
158109|NCT01496547|"~     Patients with refractory and relapse leukemia had poor outcome even with allogeneic stem cell~     transplantation. In our previous retrospective study, the overall survival is 14.6+/-8.8%~     while 90% patients eventually relapsed with marrow ablative conditioning mostly standard~     iv-Bu-Cy or Cy-TBI. The accumulated TRM is 29.5+/-11.5%. Thus our data suggested that the~     conventional transplantation approach may not be able to overcome the refractory disease. A~     new strategy to combined a low dose regimen following intensive chemotherapy for tumor~     reduction seems to be effect in both relapsed. high-risk and refractory AML or ALL. In this~     study, we focus on a new treatment strategy for particular refractory AML patients.~   "
158110|NCT01496534|"~     This is a phase Ib dose escalation study of dovitinib given in combination with either~     gemcitabine plus cisplatin or carboplatin in patients with advanced solid tumors. Patients~     with advanced solid tumors, for whom treatment with gemcitabine plus cisplatin or carboplatin~     would otherwise be warranted, will be enrolled. The dose of dovitinib will be escalated in~     successive cohorts using standard 3+3 dose escalation rules. Patients will continue~     treatment, in the absence of prohibitive toxicity, until disease progression. The study will~     define the recommended phase II dose of these combination regimens.~   "
158111|NCT01496521|"~     Evidence from laboratory studies suggests that aspirin and tea polyphenols may have an~     antineoplastic effect in esophageal squamous cell carcinoma (ESCC). To assess the safety and~     efficacy of aspirin and tea polyphenols for preventing ESCC, the investigators designed this~     double-blind, randomized controlled clinical trial. Research project is planned to recruit~     10,000 participants with the ages of 40-60 years in Fengfeng city, Hebei province, China,~     which has been known as a high incidence region of ESCC. All the participants receive~     endoscopic examination. Lugol's chromoendoscopy is used to identify esophageal unstained~     lesions (USLs). The location and size of each USL will be recorded followed by collecting~     biopsy samples from each USL. Participants with USL are randomly assigned to receive 100 mg/d~     of aspirin (n=200), 100 mg/d of tea polyphenols (n=200), or placebo (n=200) for six months.~     Follow-up consists of 2 endoscopic surveillance cycles (the first interval will be at six~     months and the second at 3 or 5 years later). The primary outcome measure was occurrence of~     high grade dysplasia and invasive ESCC. Secondary outcome was the mortality of the~     participants and adverse events.~   "
158112|NCT01496508|"~     Respiratory distress syndrome (RDS) is common in preterm infants born at less than 32 weeks~     gestation; surfactant and mechanical ventilation have been the standard treatment. However,~     despite advances in neonatal respiratory care, a considerable number of preterm infants~     develop chronic lung disease, termed bronchopulmonary dysplasia (BPD), which is associated~     with neonatal death, prolonged neonatal intensive care stay, and impaired neurodevelopment.~     High-frequency oscillatory ventilation (HFOV) was developed as a new ventilation technique in~     the late 1970s. It was expected to result in less BPD and death as a primary model of~     ventilation compared to conventional ventilation (CV) in the treatment of RDS. However, there~     is disagreement concerning the advantage of HFOV over CV in the treatment of RDS in preterm~     infants regarding the prevention of death, BPD, intraventricular hemorrhage, and~     periventricular leucomalacia in the short term. The purpose of this study was to compare the~     efficacy and safety of HFOV and CV in preterm infants with severe RDS.~   "
158113|NCT01496495|"~     This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic~     syndromes (MDS) will receive investigational study drug ARRY-614.~      This study has 2 parts. In the first part, patients will receive increasing doses of study~     drug in order to achieve the highest dose of the study drug possible that will not cause~     unacceptable side effects. Approximately 50 patients from the US will be enrolled in Part 1~     (Completed).~      In the second part of the study, patients will receive the best dose of study drug determined~     from the first part of the study and will be followed to see what side effects and~     effectiveness the study drug has, if any, in treating the cancer. Approximately 30 patients~     from the US will be enrolled in Part 2 (Completed).~   "
158116|NCT01496456|"~     This study is investigating the efficacy of caries lesion infiltration therapy as compared to~     the current preventative approach for early caries lesions.~   "
158117|NCT01496443|"~     The purpose of this study is to determine the pharmacokinetics and safety of TAK-875, once~     daily (QD), with and without glimepiride in participants with type 2 diabetes mellitus~     (T2DM).~   "
161698|NCT01449513|"~     This trial will be conducted to explore the biological effects in the skin following~     treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by~     reflectance confocal microscopy.~   "
158119|NCT01496417|"~     This will be a pilot study to investigate the use of belatacept (BMS) therapy in kidney~     transplant patients who have a MAPI score of greater than or equal to 8. The MAPI (Maryland~     Aggregate Pathology Index) score is a preimplantation donor scoring system which has five~     histopathological parameters that impact long-term kidney outcomes. Many kidney transplant~     recipients use calcineurin inhibitors (CNIs) as one of their anti-rejection medi cations.~     Kidney function may be affected by anti-rejection medications known as calcineurin inhibitors~     (CNIs). Sometimes CNIs can lead to toxicities and eventually loss of the kidney or episodes~     of chronic allograft nephropathy (CAN). Avoiding CNI immunosuppression and using belatacept~     therapy (BMS) instead, may be associated with improved kidney transplant outcomes.~   "
158120|NCT01496404|"~     The aim of this research project is to compare electrocautery to scalpel for laparotomy skin~     incisions, with the following objectives:~        1. To investigate whether electrocautery produces a cosmetically inferior surgical scar.~        2. To compare the rates of wound infection with each technique.~        3. To determine if electrocautery results in less postoperative pain. Our null hypothesis~          is that electrocautery is equivalent to scalpel for creating skin incisions; with~          respect to wound cosmesis, wound infection rate, and post-operative pain.~   "
158121|NCT01496391|"~     Iodine-123 labelled ortho-Iodohippuric Acid ([I-123]-OIH) was used in the early 1970's as a~     kidney imaging agent or tracer that lights-up inside your body when scanned, but over the~     years its use has declined. The most commonly used tracer is Technetium-99m labelled~     Mercaptoacetyltriglycine ([Tc-99m]-Mertiatide or [Tc-99m]-MAG3). However, long-term shortages~     may threaten the supply of the radioactive substance Tc-99m in Canada and the world. As a~     result of such shortages, there is a need to identify other types of tracers that can be used~     for imaging. [I-123]-OIH may be an alternative.~      The purpose of this study is to examine the diagnostic performance characteristics of~     [I-123]-OIH in comparison to [Tc-99m]-MAG3.~   "
158122|NCT01496378|"~     The purpose of this study is to evaluate the feasibility and efficacy of problem-solving~     skills training (PSST) to reduce distress and increase coping abilities among parents of~     youth with chronic pain. We hypothesize that parents will complete the PSST intervention and~     will find it to be an acceptable and satisfactory treatment. We also hypothesize that parents~     who receive PSST will have less distress and better coping skills than parents who receive~     standard care, and that children of parents who receive PSST will have better physical and~     emotional functioning than children of parents who receive standard care.~   "
158123|NCT01496365|"~     The purpose of this study is to evaluate the safety, tolerability and effectiveness of~     DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with~     DPN.~   "
158124|NCT01496352|"~     This is a randomized, double-blind, placebo controlled, safety, tolerability, and~     pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal~     surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02.~   "
158125|NCT01496339|"~     The purpose of this study is to investigate whether the treatment of human menstrual~     blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and~     effective.~   "
158126|NCT01496326|"~     This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment~     of ibuprofen compared to the use of a placebo topical treatment.~      A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days~     Dosing twice daily (b.i.d.)~   "
158127|NCT01496313|"~     The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day~     or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It~     will also help the investigators understand the side effects of different doses in these~     patients.~   "
158128|NCT01496300|"~     This study was initiated to investigate the impact of the computer based image free~     navigation on the precision of the cup implantation. The implantation of the acetabular~     component (cup) is known to be a critical step in hip endoprosthetics. The cup position~     influences significantly the function, the absence of pain and the longevity of the~     artificial hip joint. The image free navigation system OrthoPilot is used to control the~     positioning of the cup during surgery.~   "
158129|NCT01496287|"~     The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS~     for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.~   "
158130|NCT01496274|"~     This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control~     and prevention of bleeding episodes in subjects who have previously received factor~     replacement therapy for hemophilia B.~   "
158131|NCT01496261|"~     The purpose of this study is to compare pharmacokinetics between fixed-dose combination and~     separate combination of clopidogrel 75mg/aspirin 100mg.~   "
158132|NCT01496248|"~     The purpose of this study is to determine whether Korean Red Ginseng are effective in the~     treatment of the residual symptoms of depression as an adjuvant treatment.~   "
158133|NCT01496235|"~     Arterial hypertension is one of the most preventable risk factors for stroke, cardiovascular~     and renal disease. Cocoa is rich in a subclass of flavonoid called flavanol this increase~     nitric oxide production and is involved in controlling blood pressure.~   "
158134|NCT01496222|"~     This is a prospective, double-blinded, control trial. The Montreal Cognitive Assessment is~     used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients,~     scheduled for general, vascular or urological surgery under general and/or regional~     anesthesia.~   "
158135|NCT01496209|"~     A double blinded and placebo-controlled, dose escalation, single-center safety and~     preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in~     subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document~     myocardial regeneration in patients with chronic scar.~   "
158148|NCT01496040|"~     The purpose of the study is to assess the safety and efficacy of the active substance~     rAAV-2/4.hRPE65 in patients with Leber Congenital Amaurosis or Congenital severe early-onset~     retinal degeneration associated with RPE65 mutation.~   "
158149|NCT01496027|"~     The aim of the study is to compare the values of cerebral tissue oxygenation measured~     simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.~   "
158150|NCT01496014|"~     The purpose of this study is to characterize the bacteria in the wound bioburden at the~     time of definitive wound coverage/closure of severe tibia fractures in both the military and~     civilian populations.~   "
158136|NCT01496196|"~     Hemoptysis is defined as the expectoration of blood from respiratory tract, a spectrum that~     varies from blood-streaking of sputum to coughing up large amounts of pure blood.~      Massive hemoptysis variably defined as the expectoration of 100-600 ml over 24-h period.~      The most common site of bleeding is the tracheobronchial tree, which can be affected by~     inflammation (acute or chronic bronchitis, bronchiectasis) or by neoplasm ( bronchogenic~     carcinoma, endobronchial metastatic carcinoma, bronchial carcinoid tumor). The bronchial~     arteries, which originate either from aorta or from intercostal arteries, and are part of the~     high-pressure systemic circulation, are the source of bleeding in bronchitis or~     bronchiectasis or endo bronchial tumors.~   "
158137|NCT01496183|"~     The purpose of this study is to look at how a two-week use of a medication called Olanzapine~     might change appetite, physical activity, resting metabolic rate, body composition, and~     weight in healthy men.~   "
158138|NCT01496170|"~     This study will assess the safety and pharmacodynamics of three different doses of MK-8931, a~     ß-secretase inhibitor, in participants with mild to moderate Alzheimer's Disease (AD).~   "
158139|NCT01496157|"~     The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor~     of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC), as a PET imaging biomarker~     of prostate cancer detection and aggressiveness at initial diagnosis. PSMA is a well~     characterized histological marker of prostate cancer tumor aggressiveness but a quantitative~     non-invasive method for PSMA detection and monitoring is not currently available. Development~     of such an imaging biomarker would be useful to differentiate indolent from aggressive~     prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies.~     The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake~     in metastatic prostate cancer and feasibility for prostate cancer imaging. The investigators~     propose to study patients initially diagnosed with biopsy-positive prostate cancer to~     determine if DCFBC uptake and location by PET imaging will be positively correlated with~     prostate cancer by prostatectomy tissue step-section analysis. DCFBC uptake at sites of~     suspected metastatic disease will be compared to conventional imaging modalities (CT, bone~     scan) and biopsy results when available. In addition, DCFBC-PET uptake quantification will be~     compared with expression levels of PSMA and other prostate cancer relevant markers (PSA,~     Ki-67, TMPRSS2-ERG) by prostate tissue immunohistochemistry analysis and compared with~     clinical prognostic markers (PSA, Gleason score, clinical stage, Partin tables derived~     prediction of pathologic stage).~   "
158140|NCT01496144|"~     Background: Models have tried to explain the driving mechanisms behind chronic non specific~     low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered~     responses at spinal and/or supraspinal level may affect the perception of pain and degree of~     disability of CNSLBP patients. Recent clinical recommendations still propose active exercises~     (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related~     manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic~     effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The~     aim of this study was first, to assess whether MT has an instant analgesic effect, and~     second, to compare the long-lasting effect on functional disability of MT followed by AE to~     sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities,~     randomly distributed into 2 treatment groups, received either spinal~     manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned~     ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were~     delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain~     intensity (Visual Analogue Scale) before and immediately after the first intervention of each~     therapeutic session. Pain intensity, disability (Oswestry Disability Index) and~     fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before~     treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.~   "
158141|NCT01496131|"~     This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate~     cancer.~   "
158142|NCT01496118|"~     Relapsed/refractory Multiple Myeloma (MM) is an incurable disorder with a poor prognosis.~     Carfilzomib is a novel proteasome inhibitor with activity in this setting. Panobinostat is a~     pan-deacetylase inhibitor which has shown synergistic cytotoxicity in vitro and in vivo with~     proteasome inhibitors. The combination should enhance the activity of both agents against~     myeloma cells. In Phase I, the optimal doses of the combination of carfilzomib and~     panobinostat will be determined. Assuming this combination is feasible, the Phase II portion~     will proceed using the doses determined in Phase I.~   "
158143|NCT01496105|"~     The purpose of this study is to determine whether the topical use of lidocaine spray 10% on~     the cervix is an effective way to reduce pain during IUCD insertion.~   "
158144|NCT01496092|"~     The overarching aim of this proposal is to examine the effects of usual protein diet~     supplemented with keto acid (KA) on insulin sensitivity in patients on peritoneal dialysis~     (PD). The investigators will achieve this goal through a randomized controlled trial of~     administration of usual protein diet plus KA versus usual protein diet alone in patients on~     peritoneal dialysis (PD) over a period of 6 months. If successful, the results of this study~     will provide potential avenues for improvement of metabolic profile of patients on PD and~     possibly improve long-term outcomes such as cardiovascular disease risk and death.~   "
158145|NCT01496079|"~     Study objectives are to compare~        -  influenza antibody levels in infant sera and maternal colostrum or breast milk at~          delivery, 2, and 6 months women who receive influenza immunization in early pregnancy,~          late pregnancy, or no influenza immunization during pregnancy and their infants~      Study hypotheses are that infants born to pregnant women who receive influenza immunization~     in late pregnancy will have~        -  higher levels and a longer serum influenza antibody duration in sera (hemagglutination~          inhibition (HAI) titers) and colostrum/breast milk (influenza-specific IgA and IgG by~          enzyme-linked immunosorbent assay (ELISA) than infants of women immunized in early~          pregnancy or not immunized~   "
158146|NCT01496066|"~     The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery~     Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.~   "
158147|NCT01496053|"~     Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in~     patients with ulcerative colitis (UC) and Crohn`s disease (CD), experience clinical,~     biochemical and genetical improvement in their disease.~      A prospective randomised study comparing the mushroom extract with placebo.~   "
158151|NCT01496001|"~     The initial aesthetic and functional conditions are recorded with the help of the Breast~     Cancer Treatment Outcome Scale (BCTOS),an international validated questionnaire, and the~     Breast Cancer Conservative Treatment - cosmetic results (BCCT.core) validated computer~     software, allowing for comparison. Determination of the initial quality of life is measured~     with the European Organisation of Research and Treatment of Cancer - Quality of Life~     Questionnaire number C30-BR23 (EORTC QoL C30-BR23).~      Patients then undergo surgical treatment according to institutional protocols. Following~     conventional marking of the orientation of the specimen, it is measured by an analytical~     scale.~      Histological examination of the specimen will record the largest diameters, and parameters of~     the lymph nodes, according to the institutional protocol.~      On the 4th week following surgery, assuming that wound healing is completed, patients' data~     are again recorded in BCTOS, BCCT.core and EORTC QoL C30-BR23. A third set of data are gained~     after completion of adjuvant radiotherapy, on the 8th postoperative month. Magnetic resonance~     imaging is performed to assess the volume of the contralateral breast.~      Tumor - breast volume ratio is calculated, and matched up with cosmetic results in each~     quadrant, threshold value in the quadrants, above of which it is not advisable to perform~     conventional breast conserving surgery due to poor outcomes.~   "
158152|NCT01495988|"~     This phase 2 clinical trial randomizes patients with BRAF mutant melanoma to either (1)~     standard of care (SOC) - BRAF inhibitor vemurafenib in combination with MEK inhibitor~     cobimetinib; or, (2) SOC plus bevacizumab, an anti-VEGF antibody that suppresses new blood~     vessel formation and can stimulate the immune system. Previous clinical studies in melanoma~     have shown that bevacizumab may improve clinical benefit (progression free survival) if~     combined with ipilimumab or abraxane. Preclinical studies suggest that VEGF increase plays a~     role in resistance to BRAF inhibitors. This randomized study will ask whether the addition of~     bevacizumab to targeted therapy SOC in BRAF mutant melanoma can improve response rates and~     clinical benefit. Patients may have received no therapy for advanced disease or up to 2 prior~     therapies, excluding BRAF and MEK inhibitors.~   "
158153|NCT01495975|"~     The goal of this research is to evaluate the impact and feasibility of using web-based~     patient-provider communication and a remote glucose monitoring tool to improve~     post-hospitalization glycemic control and patient self-care. The investigators hypothesize~     that providing patients this web-based tool over a 4-week period after discharge to home will~     result in more effective glycemic control compared to usual care, and that patients with~     access to the tool kit will have a trend towards improved diabetes self-management and less~     diabetes-related distress.~   "
158154|NCT01495962|"~     Damage control laparotomy (DCL) is a life saving maneuver used with success in trauma and~     acute general surgery patients. The technique involves source control of sepsis and~     hemorrhage with an abbreviated laparotomy. In other words, the surgical procedure is cut~     short to allow for resuscitation in the ICU after the immediately life threatening pathology~     is treated. Planned re-exploration is then performed within 24-48 hours. It is at this~     procedure that the injuries are reconstructed. This technique, unfortunately, has several~     complications implicit with its use including wound infection, enterocutaneous fistula~     formation, and intra-abdominal abscess development.[1] Additionally, in patients whom primary~     fascial closure is not achieved, extensive abdominal wall reconstruction will be required in~     6-12 months. The key for preventing these complications is definitive closure of the~     abdominal fascia, however, 10-50% of patients will have a planned ventral hernia with an open~     abdominal wound at dismissal [1,2] Proven methods for decreasing the rate of planned ventral~     hernia utilize tension in the midline to counter the effects of lateral abdominal muscular~     retraction.[3,4,5] Despite these improvements, however, the planned ventral hernia rate~     continues to be substantial.[2] Botulinum toxin a (BTX) is an FDA approved neuron modulating~     agent which has been used extensively in cosmetic, motor and pain disorders over the past 20~     years [6,7]. The toxin blocks acetylcholine and pain modulator release (calcitonin gene~     related peptide and substance P) from the pre-synaptic cholinergic nerve terminal. The~     peptides are unable to bind at their motor end plate receptors through a process that cleaves~     proteins involved in the transport protein cascade. This results in flaccid paralysis and~     neuromodulation of the abdominal wall muscles resulting in reduced lateral tension and pain.~     Theoretically, this could increase the rates of primary fascial closure, improve pain~     sensation, decrease the rate of complications associated with open abdomens all while~     lowering the costs and need for future abdominal wall reconstruction.~   "
158155|NCT01495949|"~     During induction for cardiac surgery, patient hemodynamic stability is achieved by using~     anesthetic drugs which least affects hemodynamics such as benzodiazepines, etomidate.~     Etomidate although has been used for a long time but its safety regarding cortisol synthesis~     suppression is still doubtful. This study measures the changes in cortisol levels during~     cardiac surgery with the use of cardiopulmonary bypass by comparison between two inductive~     agents (etomidate and thiopentone). Recording data also include hemodynamic changes during~     induction, inotropic use for coming of cardiopulmonary bypass, blood glucose levels, amount~     of insulin usage, length of ICU and hospital saty.~   "
158156|NCT01495936|"~     Patients requiring one lung ventilation (OLV) for open thoracic surgery will be ventilated~     (breathing performed by a breathing machine) during anesthesia using a lung protective~     ventilation strategy (small breath volumes at 6ml/kg). During thoracic surgery the~     anesthesiologist is able to ventilate only one lung by inserting a special breathing tube,~     allowing the surgeon to operate on the non ventilated (diseased) lung. In a randomized trial~     two interventions used to improve blood oxygen levels during one lung ventilation will be~     compared . The two interventions are:~        1. Continuous Positive Airway Pressure (CPAP) applied to the non ventilated (non breathing)~          lung and~        2. Positive End Expiratory Pressure following a lung Recruitment Maneuver (RM-PEEP) to the~          ventilated (breathing) lung.~      CPAP is performed by applying a steady flow of oxygen to the non ventilated (non breathing)~     lung at a continuous gentle pressure of 5cmH20.~      To perform a Recruitment Maneuver (RM) the anesthesiologist inflates the ventilated~     (breathing) lung with oxygen, holding the breath for 25 seconds so all the lung is opened up.~     Immediately after the recruitment maneuver PEEP will be applied. PEEP is an action which also~     helps keep the lung open, maintaining the benefits achieved by the RM. It is performed by~     adjusting settings on the ventilator (breathing machine). The ventilator creates and applies~     a gentle pressure (5cmH20) to the ventilating lung at the end of each breath.~      The outcome measure will be the oxygen content in blood (PaO2), measured in mmHg, using blood~     sample analysis.~      The null hypothesis is that compared to CPAP, RM-PEEP does not significantly increase the~     oxygen content of blood during OLV when using a lung protective ventilation strategy.~   "
158215|NCT01495143|"~     Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery.~     Minimal invasive surgery is postulated to result in less muscle damage and better outcome.~     The aim of this study is to monitor metabolic changes of the paraspinal muscle and to~     evaluate paraspinal muscle damage during surgery using microdialysis (MD).~   "
158157|NCT01495923|"~     The purpose of this study is to determine whether pharmacotherapy or epidural steroid~     injections are a better treatment for lumbosacral radicular pain.~      142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be~     randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will~     be allocated to receive an epidural steroid injection (ESI; group I), with an equal number~     allocated to receive gabapentin (group II). Patients & evaluating physicians will be blinded.~     Follow-up will be through 3-months after treatment.~   "
158158|NCT01495910|"~     The purpose of this study is to determine the minimum dose of abiraterone acetate needed to~     decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid~     replacement for classic 21-hydroxylase deficiency.~   "
158159|NCT01495897|"~     Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive~     muscle contractions of opposite muscles that lead to abnormal twisting movements or odd~     postures. Essential tremor is a slowly progressive neurologic disorder characterized by the~     appearance of a tremor during the voluntary movement. The pathophysiology of dystonia or~     essential tremor is not fully elucidated. Dystonia and essential tremor are associated with~     dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the~     cerebellum and cerebellar pathways has also been recently suggested.~      The investigators propose to study 30 patients having a primary dystonia (15 DYT11~     genetically documented), 15 patients having an essential tremor without deep brain~     stimulation and 15 patients having an essential tremor with deep brain stimulation.A group of~     30 healthy volunteers will be recruited and tested according to the same modalities. They~     will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.~      Eye position will be sampled with a video-based monocular eye tracker (SMI, Germany) before~     and immediately after an adaptation task. Saccade adaptation is evaluated as the percentage~     change in the mean saccade amplitude between pre-test and post-test.~      Expected results:~        -  no or fewer alteration of the performance to the adaptation task in the Parkinson group~          than in the Essential Tremor group/ dystonia group.~        -  abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor~          group, providing further neurophysiological evidence of cerebellar dysfunction.~   "
158160|NCT01495884|"~     This study is a Phase I/II open label, multi-centre trial. Patients with HER2+ve metastatic~     breast cancer, following disease progression during, or after, treatment with trastuzumab and~     taxanes, will be treated with Lapatinib (Tyverb™ 500-1250 mg orally daily - depending on the~     maximum tolerated dose (MTD) determined in the Phase I part of the study) plus Myocet™, 50-60~     mg/m2 i.v q3 weeks).~      Within the Phase I part, doses are assigned at registration according to the dose escalation~     scheme.~      The dose for the Phase II part of the trial will be based on the MTD established in the Phase~     I part of the study.~      Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity~     of study therapy. Safety assessments will be performed every 3 weeks for the first 24 weeks.~     Efficacy assessments (radiological examination) will be performed on all patients every 8~     weeks (± 7 days) for the first 24 weeks. Cardiotoxicity assessments will be performed at~     weeks 6 and 12. From week 24, safety, efficacy and cardiotoxicity assessments will be~     performed every 12 weeks and at the end of treatment (disease progression, unacceptable~     toxicity or patient withdraws consent).~   "
158161|NCT01495871|"~     Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It~     has been called the signature wound of the Iraq war because of its frequency among troops.~     TBI is associated with many chronic disabilities. Physical alterations include reduced~     exercise tolerance and profound muscle weakness, whereas psychological alterations include~     diminished sense of well-being, depression, fatigue and anxiety. Muscle and brain tissues~     rely upon circulating blood amino acids as precursors for metabolic functions. The~     investigators have shown that even one year after injury, plasma valine, an essential amino~     acid (EAA), was markedly reduced in patients with TBI compared to healthy controls. The~     investigators speculate that low plasma valine concentration contributes to chronic fatigue~     after TBI, since valine and tryptophan compete for the same transporter into the brain, and a~     low plasma valine concentration will allow more tryptophan to be transported. As a~     consequence, increased brain tryptophan will increase serotonin production, which may~     significantly contribute to the development of fatigue. Thus, the investigators will test if~     restoring valine concentration in persons with TBI may reduce fatigue perception and improve~     physical and neuropsychological function. Further, the investigators have previously shown~     that EAA intake has an anabolic effect in healthy young and elderly individuals. However, no~     data are currently available in persons recovering from TBI. Thus,the investigators will also~     test if EAA and/or valine can improve muscle mass in patients with TBI.~   "
158162|NCT01495858|"~     The objective of the study is to evaluate the efficacy and safety of a single oral dose of~     naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with~     postsurgical dental pain and phase advanced sleep.~   "
158163|NCT01495845|"~     The purpose of this study is to determine the feasibility of pharmacogenomics testing in a~     community pharmacy using clopidogrel as an example. The investigators hypothesize that this~     testing is feasible in this setting.~   "
158164|NCT01495832|"~     The Canadian population, as is the case in most developed countries, is ageing and becoming~     increasingly overweight and/or obese. Both ageing and obesity are associated with reduced~     cognitive performance which can impact adversely on the ability to undertake daily activities~     and increases the risk of loss of independent living and reduced quality of life. The~     investigators predict that consumption of ½ cup of pulses per day for 12 weeks will improve~     cognitive function in older overweight/obese adults and thus decrease the rate of cognitive~     decline that occurs in this at-risk population.~   "
158216|NCT01495130|"~     This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors~     during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such~     as ultrasound, may help find prostate cancer and find out how far the disease has spread~     during surgery~   "
158217|NCT01495117|"~     The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone~     iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver,~     hepatobiliary, small or large bowel, stomach) is effective.~   "
161699|NCT01449500|"~     To determine whether simultaneous use of L. reuteri ProGastria and proton pump inhibitors can~     eradicate H. pylori in humans in the absence of antibiotics.~   "
158165|NCT01495819|"~     The proposed study will examine the threshold for nicotine self-administration (NSA) using~     five different nicotine doses in young adult male and female non-dependent smokers (light and~     intermittent smokers or LITS). We propose a double-blind, placebo-controlled study that will~     enroll 195 individuals, targeting a total of 72 completers (36 male and 36 females). In each~     of the five experimental sessions, smokers will be randomly assigned to one of the five doses~     of nicotine (0.0125, 0.025, 0.05, 0.1 and 0.2 mg/70 kg). The highest dose, 0.2 mg/70 kg,~     corresponds to nicotine delivered by about one or two puffs of a cigarette. At the beginning~     of each experimental session, smokers will sample the assigned both the nicotine dose for~     that experimental session, and the placebo (saline) dose, followed by the opportunity to~     choose between nicotine and placebo for a total of ten choices over a 150-minute period. The~     main outcomes will be threshold dose (the minimum dose of nicotine that is self-administered~     more than placebo) and the slope of dose-response for nicotine self-administration (changes~     in nicotine self-administration per unit change in nicotine dose). We will also collect~     measures of nicotine intake (cotinine), nicotine clearance (3-hydroxycotinine (3-HC) /~     cotinine), and self-report drug effects~   "
158166|NCT01495806|"~     Background: Functional abdominal pain disorders (FAPD) are common in school-aged children;~     however, there is no reliable treatment.~      Aim: To determine the efficacy and safety of glucomannan for treating FAPD in children.~      Trial Setting: Department of Pediatrics, The Medical University of Warsaw.~      Intervention: Patients will be enrolled in a double-blind, randomized controlled trial in~     which they will receive either glucomannan (10g) or placebo for 4 weeks.~   "
158167|NCT01495793|"~     This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple~     administrations of the rotigotine transdermal system. The study was conducted in adolescent~     subjects (13 to <18 years of age) with idiopathic Restless Legs Syndrome (RLS).~   "
158168|NCT01495780|"~     Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor~     visits, using things like at-home breathing tests, electronic diaries to answer~     questionnaires, and other monitoring devices. The hypothesis of this study is that the health~     and quality of life of people with COPD who do RHM for one year will be better than people~     with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with~     chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema,~     and are current or former smokers will be invited to participate. This study is paid for by~     eResearch Technology (eRT).~      Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will~     participate in RHM. RHM will involve daily monitoring at home using a few electronic devices:~     blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring.~     Visits will include physical exam and medical history, ECG, questionnaires, breathing tests,~     and exercise tests.~   "
158169|NCT01495767|"~     Data about psychodynamics in uveitis patients are scare. A negative impact of disease is~     described not only in adult patients with active, but also with quiescent disease. During~     adolescence even less is known about psychodynamics although this is an especially sensible~     and challenging stage of life. Given the assumption that juvenile patients with quiescent~     disease still could suffer from emotional distress, this would require special attention.~      In this study the investigators evaluate the impact of juvenile uveitis on HRQoL and~     attempted to identify clinical and demographic factors contributing to an impaired health~     status. The investigators limit the study to patients with quiescent uveitis and good visual~     function in at least one eye to exclude additional negative stressors. As there are no~     validated uveitis-specific psychometric questionnaires evaluating QoL available yet, the~     investigators use age-appropriate generic instruments. This should allow obtaining an~     overview about the adolescents' general Health-related Quality of Life (HRQoL) and whether~     psychological interventions should be offered to this sensitive patient group.~   "
158170|NCT01495754|"~     The purpose of the study is to investigate whether different doses of caffeinated coffee~     consumption has acute effects on subjective appetite feelings, energy intake and biochemical~     markers related to appetite, inflammation and glucose metabolism compared to water~     consumption in normal weight and overweight/obese participants.~   "
158171|NCT01495741|"~     This study will assess asenapine (Sycrest®) use in participants with bipolar disorder;~     comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine~     (Zyprexa®). The occurrence of identified and potential clinically important risks will also~     be assessed.~   "
158172|NCT01495728|"~     Hypothesis: The group of Cervical Radiculopathy patients receiving thoracic thrust~     manipulation will demonstrate immediate and short term significant clinically important~     changes in outcomes when compared to the sham manipulation group.~   "
158173|NCT01495715|"~     The objective of the study is to determine whether administration of idebenone can shorten~     the time to improvement of visual acuity in patients with chronic vision loss due to LHON.~   "
158174|NCT01495702|"~     This study will evaluate the noninferiority of Stribild®~     (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF))~     single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse~     transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50~     copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also~     evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of~     treatment.~   "
158175|NCT01495689|"~     Cigarette smoking is the most harmful and quitting smoking is very difficult. Despite~     quitting, it is very difficult to stay quit for long term. In Ottawa the investigators are~     very lucky to have designed and developed the Ottawa Model for Smoking Cessation (Ottawa~     Model). This project is an end result of pain staking research. The Ottawa Model has been~     implemented very successfully to the hospitalized patients and has shown very promising~     results of higher quitting rates.~      Our objective is to modify the Ottawa Model to suit the needs of patients attending~     out-patient respirology clinics. The investigators aim to apply the modified Ottawa Model~     along with the SmartCard to the adult smokers who attend the investigators out-patient~     Respirology clinic at the Ottawa Hospital.~      The investigators aim to train a nurse in clinical aspects and implementation of the~     protocols related to the Ottawa Model. The trained nurse will contact the smokers attending~     the clinic. Those subjects willing to participate in this study will be divided in to two~     groups. One group of subjects will get counseling and SmartCard on the day of the clinic and~     follow-up phone calls. The SmartCard is worth $110 toward the purchase of quit smoking~     medications (i.e. nicotine patch/gum, varenicline, or bupropion). The subjects can re-deem~     the card at the investigators hospital pharmacy. Those in the control group will be~     followed-up as the investigators are currently doing i.e. with standard smoking cessation~     counseling from the clinic physician and the nurse, +/- prescription for smoking cessation~     aids without access to the study nurse and the extra counseling or SmartCard. The~     investigators aim to find increased quitting rates in the group getting on-site access to the~     smoking cessation aids with the Smartcard and counseling.~      There are no studies implementing the Ottawa Model along with the SmartCard in out-patient~     respirology setting so far. The Ottawa Model has proven to be very successful in the~     in-patient subjects. Thus, the investigators believe, the investigators can modify the Ottawa~     Model and make it fit the out-patient Respirology setting and increase the quitting rates.~   "
158176|NCT01495676|"~     If radical cystectomy remains the standard of care for muscle invasive bladder cancer,~     consequences of this surgical procedure are often harsh. Over the past years, concurrent~     chemo-radiotherapy has imposed itself as an alternative treatment. Published data on~     concomitant radiochemotherapy (radiotherapy/cisplatin or~     radiotherapy/cisplatin/5-fluorouracil combinations) showed local control rates with bladder~     preservation at 5 years ranging from 40% to 65% according to the disease stage, and overall~     survival probabilities ranging from 40% to 50% at 5 years. In order to improve local and~     systemic prognosis, evaluation of other chemotherapy agents with higher radiosensitizing~     effect, such as gemcitabine, is justified. Gemcitabine possesses its own anti-cancer~     activities on urothelial diseases and has a synergetic activity with cisplatin. The~     investigators completed a monocenter phase I study combining radiotherapy, cisplatin, and~     twice-weekly gemcitabine, and determined a recommended dose of gemcitabine 25 mg/m². The~     objective of the present study is to evaluate the combination of radiotherapy + cisplatin +~     gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial~     cancer patients.~   "
158177|NCT01495663|"~     The purpose of this study is to determine the recommended dose of I-131-CLR1404, a~     radiolabeled therapy compound, for treating subjects with cancer that does not respond to~     treatment or has returned. The identified recommended dose in this study will be used as the~     optimal dose of I-131-CLR1404 in subsequent clinical trials conducted for later phase~     clinical development.~      Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the~     study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase,~     subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on on~     the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of~     biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated,~     the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects~     will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be~     in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable~     toxicity through 56 days after the therapy dose infusion with follow-up for up to one year.~      All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to~     injection of the dosimetric dose, and continuing for 14 days after the administration of the~     therapy dose.~   "
158178|NCT01495650|"~     Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining~     regular dietary counseling and tailored physical activity is associated with reduced~     cancer-related fatigue and can improve quality of life and body weight control. We propose to~     conduct a randomized controlled trial which purpose is to evaluate the effect of an~     intervention combining physical exercise and nutritional therapeutic education on~     cancer-related fatigue. To gain behavioral change towards PA and nutrition habits,~     interventions will take place within hospitals, on the same days of adjuvant treatments.~   "
158179|NCT01495637|"~     The GIFT study is a prospective, multi-center, interventional trial using the drug GM-CSF for~     the reversal of innate immune suppression in critically injured children. The study will be~     conducted in two phases, a dose-finding phase then an efficacy phase. The dose-finding phase~     is the current active phase of the study. The central hypothesis of the study is that~     immunomodulation with GM-CSF will result in reduction in the risk of nosocomial infection~     after critical injury in high-risk children through safe, rapid, and sustained improvement in~     innate immune function.~   "
158180|NCT01495624|"~     Patients undergoing rotator cuff repair or subacromial decompression at the investigators~     institution are frequently hospitalized overnight due to inadequate pain relief after~     resolution of interscalene brachial plexus blocks. For ropivacaine 0.5%, the investigators~     usual local anesthetic, previous studies report an analgesic duration of 11.1 ± 5 hours~     without epinephrine and approximately 12 hours with epinephrine. Consequently, a method of~     prolonging analgesia from a brachial plexus block without the extra equipment and logistical~     difficulties of indwelling catheters would benefit both patients and caregivers. A potential~     approach is use of adjuvant drugs that prolong block duration when added to the local~     anesthetic.~      In addition to the usual adjuvant anesthetic drugs, investigators have begun to evaluate~     glucocorticoids as adjuvants for regional anesthesia. Known for their anti-inflammatory,~     analgesic, immunosuppressive, and antiemetic properties, these corticosteroids exert their~     effects by inhibition of phospholipase A2 as well as changes in cell function induced by~     glucocorticoid receptor activation. Although associated with significant toxicity when~     administered in large doses for long periods, emerging literature suggests that a single~     perioperative dose of glucocorticoid is safe. Several studies, including a recent trial at~     the investigators institution, have demonstrated the efficacy of dexamethasone in prolonging~     regional anesthetics. Available data thus suggest that combining glucocorticoids with local~     anesthetics prolongs block duration. However, systemic glucocorticoids have also been shown~     to reduce postoperative pain. This raises the question whether the beneficial effects of~     adding glucocorticoid to a regional anesthetic is solely due to local effect or is mediated~     at least in part by systemic action. Previous trials, however, have not addressed this~     important issue. If this beneficial effect of analgesic duration is mediated by systemic~     action, adding dexamethasone to the local anesthetic mixture may be unnecessary. Although no~     study has reported neurotoxicity from perineural dexamethasone and laboratory data appear to~     confirm the safety of this route, achieving similar results with more conventional~     administration would be desirable for two reasons. First, conventional intravenous dosing is~     convenient, useful for other reasons (for example, postoperative nausea prophylaxis), and~     well-studied. Second, equivalent (or not equivalent) results from systemic dosing would~     provide valuable information about the mechanism behind dexamethasone's effect on block~     duration.~   "
158181|NCT01495611|"~     The purpose of this research study is to identify factors and genes (the DNA material that~     determines the makeup of the human body) that may be associated with how children respond to~     pain medication. Specifically, the investigators want to study factors that may be associated~     with pain sensitivity, morphine requirement after surgery and side-effects from morphine and~     other pain medications. The investigators expect that the information obtained in this~     research study will help us to develop more effective, safe, and tailored treatment options~     in the future.~   "
158182|NCT01495598|"~     Background:~      - Pomalidomide is a drug that can treat cancer through several mechanisms. It is taken by~     mouth (orally). Pomalidomide can help treat cancer by blocking certain factors that promote~     tumor growth or by stimulating the immune system to attack tumor cells. It also prevents the~     growth of new blood vessels that help cancer grow. Researchers want to see if pomalidomide~     can treat Kaposi sarcoma, a rare and potentially fatal skin cancer. Because Kaposi sarcoma~     may be associated with human immunodeficiency virus (HIV) infection, researchers want to test~     the drug in people with and without HIV infection.~      Objectives:~      - To see if pomalidomide is a safe and effective treatment for Kaposi sarcoma in people with~     or without HIV.~      Eligibility:~        -  Individuals at least 18 years of age who have Kaposi sarcoma.~        -  Participants may or may not have HIV infection.~      Design:~        -  Potential participants will be screened with a medical history and physical exam. Blood~          and saliva samples will be taken and a chest X-ray will be performed. A skin biopsy of a~          Kaposi sarcoma lesion may be performed if one has not already been done. Other imaging~          studies may be performed if needed.~        -  Participants will take pomalidomide capsules every day for 3 weeks, followed by a 1-week~          break. These 28 days are one cycle of treatment.~        -  Participants will have up six cycles of treatment, unless the lesions completely resolve~          sooner. If there are signs of improvement after six cycles but the lesions are not~          completely gone, up to another six cycles of treatment may be given.~        -  Treatment will be monitored with frequent blood tests and other studies including~          photograph and other imaging of skin lesions.~        -  Participants will have regular follow-up visits for 5 years after stopping treatment....~   "
158183|NCT01495585|"~     Background:~        -  Chronic hepatitis D is a severe disease of the liver caused by infection with the~          hepatitis D virus. The hepatitis D virus can only infect a person who also has hepatitis~          B; therefore, people with delta hepatitis have both hepatitis B and hepatitis D virus~          infection. Most people with hepatitis D eventually develop cirrhosis, which causes~          scarring and damage to the liver. There is currently no effective treatment for chronic~          hepatitis D.~        -  Lonafarnib is a drug that was originally designed to treat different types of cancer. It~          may be able to prevent the hepatitis D virus from reproducing itself. However, it has~          not been tested on people with hepatitis D. Researchers want to study different doses of~          lonafarnib to see how they affect virus levels and other symptoms of hepatitis D.~      Objectives:~      - To test the safety and effectiveness of lonafarnib as a treatment for chronic hepatitis D.~      Eligibility:~      - Individuals at least 18 years of age who have chronic hepatitis D.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood and urine tests, eye exams, and imaging studies of the liver and gall bladder. A~          liver biopsy may also be performed.~        -  Participants will receive either lonafarnib or placebo twice a day for 28 days. For the~          first 3 days, participants will stay in the hospital to have frequent blood tests.~          Participants will have four more clinic visits (on days 7, 14, 21, and 28) for blood and~          urine tests. Eye exams and heart function tests will also be given. Men may be asked to~          provide sperm samples for further testing.~        -  After the 28 days of treatment, participants will stop taking the drug or placebo. They~          will have regular followup visits for up to 6 months after stopping treatment....~   "
158184|NCT01495572|"~     Background:~      - Some cancer treatments collect a patient s own blood cells to use as specialized~     cancer-fighting cells. Collected white blood cells known as PBL (peripheral blood~     lymphocytes) can use to isolate special cells that can fight tumors. Before treatment with~     PBL, chemotherapy is given to destroy existing white blood cells so that the new cells can~     survive and attack the tumors. After PBL treatment, aldesleukin is given to help the new~     cells grow. Researchers want to see if special white blood cells that recognize a specific~     protein that is present in melanoma cells (melanoma antigen recognized by T cells (MART)) can~     cause tumors to shrink. These white blood cells will be tested with and without aldesleukin.~      Objectives:~        -  To test the safety and effectiveness of white blood cells that target MART in the~          treatment of melanoma.~        -  To test white blood cells that target MART with and without aldesleukin.~      Eligibility:~      - Individuals at least 18 years of age who have melanoma that has not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a medical history and physical exam. Blood and urine~          samples will be taken. Imaging studies such as x-rays or magnetic resonance imaging~          scans will be performed.~        -  Participants will provide white blood cells through leukapheresis. Researchers will~          attempt to isolate white blood cells that recognize MART~        -  Seven days before the start of treatment, participants will have chemotherapy.~        -  After the last dose of chemotherapy, participants will receive the MART reactive PBL~          cells. Filgrastim doses will also be given to help white blood cell counts return to~          normal. Participants will have frequent blood tests.~        -  Participants who are able to have aldesleukin treatment will start within 24 hours after~          receiving the MART reactive PBL cells. Treatment will continue for up to 5 days.~        -  Participants may have an optional tumor or lymph node biopsy to study the effects of~          treatment.~        -  If the tumor continues to grow after MART PBL treatment, participants may have one more~          round of cell collection and treatment.~        -  Participants will have followup visits for up to 6 months after receiving the MART~          reactive PBL treatment.~   "
158185|NCT01495546|"~     In Brazil, several hip surgeries performed, especially total knee arthroplasty, which~     represents 1.5 million procedures (Penedo, New, 2007). The rehabilitation of these~     individuals is slow with respect to the march because it requires an aid and not to use the~     operated leg as support for three weeks, according to conventional methods. After the third~     week, the support becomes part and after that period (sixth week), the support becomes total.~     Therefore, and in order to provide better quality of life, the goal of this work is to~     compare the march in 40 patients divided into two groups of 20 subjects each. In the control~     group, the treatment approach is the traditional, i.e., without immediate loading, while the~     other charge will be applied immediately in the operated limb. In order to verify the~     possible gain in the quality of life of these patients, the SF-36 will be applied. The march~     will be assessed with the Time Up and Go test and the force platform and the Harris Hip score~     analyze the function of the hip. Individuals will receive such care at the Institute of~     Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of São~     Paulo (IOT - HC - USP). The results of comparisons between the two groups and the clinical~     findings obtained will be subjected to appropriate statistical tests, guided by the~     principles of evidence-based clinical practice, seeking to facilitate and improve the lives~     of these individuals so they can move freely.~   "
158186|NCT01495533|"~     The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis~     with a drug coated AngioSculpt scoring balloon.~   "
158187|NCT01495520|"~     Patients with ischemic heart disease often report multiple symptoms, including angina and~     palpitations. Ranolazine has antiarrhythmic effects which are largely a result of the drug's~     effect on multiple ion channels. It remains unknown, however, whether the favorable effects~     of ranolazine on symptoms and arrhythmias are maintained over time. Aim of this study is to~     test the hypothesis that chronic treatment with ranolazine can improve the symptomatic status~     of patients with ischemic heart disease by reducing the occurrence of palpitations.~   "
158188|NCT01495507|"~     The field of patellofemoral disorders and accordant therapeutical interventions is a high~     turnover research field. It is important to verify the clinical outcome with appropriate~     measuring tools. There is evidence that the Kujala score is a reliable and widely used~     measuring instrument of patellofemoral disorders. Indeed, the Kujala score was already used~     in many studies investigating patellofemoral disorders - also in german speaking patient~     groups. Unfortunately, we are not aware of a validated german version of the Kujala score.~     Other relevant knee outcome scores were already successfully translated into german language~     and validated by previous investigators.~      So, it is the aim of our study to cross-culturally adapt and then to validate the Kujala~     score for use in German-speaking individuals with patellofemoral instability. It is~     hypothesized that the german version of the Kujala score shows:~        -  High divergent construct validity as determined by significant differences between~          patients and controls (hypothesis 1)~        -  High convergent construct validity as determined by significant correlations with other~          relevant scoring systems (hypothesis 2)~        -  High reliability (hypothesis 3)~        -  High responsiveness (hypothesis 4)~   "
158189|NCT01495494|"~     This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes.~     Prototypes were produced as an improvement to the currently marketed product.~   "
158190|NCT01495481|"~     The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the~     acute termination of Supraventricular Tachycardia (SVT).~   "
158191|NCT01495468|"~     This was a multicenter, randomized, open-label, parallel controlled phase III study, compared~     pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration~     formulation).~      All the subjects were randomized into two groups, test group (PEG somatorpin) and control~     group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled~     in control group. Considering the case loss during the clinical study, 20% of the patients~     were added in each of the group, that is 240 children were in test group and 120 children~     were in control group, totally 360 children were enrolled in the phase III clinical study.~      Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point~     of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time~     point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the~     evaluation would be made when the treatment is finished.~   "
158192|NCT01495455|"~     Osteoarthritis is by far the most common joint condition and the single largest cause of~     disability in the older population. The investigators still have a poor understanding of the~     nature of osteoarthritis and factors that influence its development and progression.~     Identification of biochemical markers that relate to cartilage loss, bony overgrowth and~     other features that occur with osteoarthritis will advance our understanding. Over the last 5~     years analytical methods have developed to measure a range of different biomarkers. This~     pilot study will use these analytical methods to measure biomarker levels in joint fluid,~     urine and blood of 50 participants with Osteoarthritis (OA) and 50 healthy volunteers.~      This study will provide novel pilot data on the changes in the composition of the synovial~     fluid, urine and blood in patients with OA. Apart from being a key target site for OA, the~     knee is a suitable joint for study because of its accessibility to clinical assessment, joint~     aspiration and imaging.~   "
158193|NCT01495442|"~     The primary objective is to admix a radiolabel with albuterol sulphate for incorporation into~     the Handihaler® device for inhalation studies. This will allow for the investigators to~     determine the regional lung deposition of drug inhaled from the standard Handihaler® device~     compared to a novel modification of the device to provide more effective dispersion and~     aerosolization of the coated albuterol powder. The new mechanism of action for~     proof-of-concept testing consists of a bead (5.1 mm; expanded polystyrene foam) coated with~     drug powder, as opposed to the standard lactose formulation-filled capsule.~   "
158194|NCT01495429|"~     The investigators aim to compare the complications between centrally and peripherally~     inserted central venous catheters in neurological intensive care unit patients. The study~     hypothesis is that peripherally inserted catheters will have more cumulative complications~     due to venous thrombosis.~   "
158195|NCT01495403|"~     This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with~     patients having cramps due to their cirrhotic liver disease.~   "
158196|NCT01495390|"~     The purpose of this study is to collect biofluid samples for the banking and usage in ALS~     research. Through comparison of these samples, the researchers hope to learn more about the~     underlying cause of ALS, as well as find unique biological markers, which could be used to~     develop new therapies.~   "
158197|NCT01495377|"~     The purpose of this study is to determine weather remifentanil induced swallowing~     difficulties increase risk for pulmonary aspiration.~   "
158198|NCT01495364|"~     This study will assess the safety and efficacy of intracoronary artery administered~     autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial~     infarction (STEMI). This will be assessed by evaluating and comparing the autologous stem~     cell treatment group to the control group in terms of the occurrence of AE's, SAE's and Major~     Adverse Cardiac Events (MACE), by the change in myocardial perfusion (RTSS) measured~     quantitatively by gated single photon emission computed tomography myocardial perfusion~     imaging (gated SPECT MPI), and other secondary endpoints such as LVEF measured by cardiac MRI~     in addition to other endpoints.~   "
158199|NCT01495351|"~     The combination of PARP inhibitor (ABT-888) with a proteasome inhibitors (bortezomib) have~     demonstrated significant anti-myeloma effects in preclinical lab and animal studies. The goal~     of this phase I trial is to evaluate in patients with relapsed or refractory multiple myeloma~     the safety, toxicity profile and tolerability of ABT-888 (Veliparib) administered on a~     schedule including twice daily oral dosing for 14 days followed by 1 week rest in combination~     with standard dosing of Bortezomib.~   "
158200|NCT01495338|"~     The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a~     placebo.~   "
158201|NCT01495325|"~     Exposure to air pollution is a well established risk factor for the development of heart~     disease. Firefighters are exposed to excess air pollution in the form of wood smoke during~     the extinguishing of forest or woodland fires. Heart attacks in on-duty firefighters have~     been linked to specific duties and in particular fire suppression, but the reasons for this~     increase in risk are not well understood. Exposure to wood smoke may alter blood vessel~     function and increase blood clot formation to explain the link between fire suppression and~     heart attacks.~      The investigators wish to determine the effect of exposure to wood smoke at concentrations~     found at the perimeter of a woodland fire on blood vessel function and clotting in healthy~     non-smoking male professional firefighters or volunteers. Volunteers will be studied before~     and after inhalation of wood smoke or clean air for one hour in a purpose built whole-body~     exposure chamber. The investigators will perform comprehensive vascular assessments~     thereafter.~      Understanding the effects of wood smoke on the blood vessels and clotting will be an~     important first step in helping to protect firefighters from heart disease. Through research,~     the investigators hope to identify methods to minimise the risk of heart attacks in~     firefighters and understand the health effects of a major source of air pollution that is~     relevant to the general population.~   "
158202|NCT01495312|"~     The purpose of this study is to determine the relationship between Intraocular Pressure (IOP)~     fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED~     Triggerfish®), during two 24-hour periods after selective laser trabeculoplasty (SLT) for~     routine treatment of glaucoma.~   "
158203|NCT01495299|"~     The purpose of this study is to determine the relationship between intraocular pressure (IOP)~     fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED~     Triggerfish®), during two 24-hour periods, before and after cataract surgery. This device has~     previously been investigated and shown to be safe and well tolerated.~   "
158218|NCT01495104|"~     This open-label, fixed-sequence, two-period study will assess the effect of multiple dose~     valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male~     volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period~     of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with~     concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.~   "
158219|NCT01495091|"~     The main purpose of this study is to examine whether changes in biomarkers during exercise~     are related to coronary artery disease demonstrated by coronary angiography or~     echocardiography.~   "
158220|NCT01495078|"~     The primary objective of the study is to determine the effect of automated daily selfreported~     symptom and weight, blood pressure and heart rate monitoring and clinical follow-up~     videoconference comigrate with clinical follow-up face in specialized hospital unit in~     reducing heart failure non-fatal events.~   "
158204|NCT01495286|"~     This research study represents a pilot, open arm study that will evaluate the safety of using~     Non−invasive Electrical Stimulation of Acupuncture Points (NESAP) in 42 newborn infants less~     than 3 days of age who require heel sticks for clinical blood sampling. The investigators~     plan to enroll 51 infants into the study in order to obtain 42 completed infants. Two sub~     studies will precede the main safety study, with 6 infants in each sub study and 30 infants~     in the main study. These two sub studies will use electrical stimulation intensities that are~     a fraction of the planned intensity of electrical stimulation that will be used during the~     main part of the study.~      The clinical trial will be performed at the University of Arkansas for Medical Sciences~     Hospital (Little Rock, AR). The study will evaluate the pain response to heel stick routinely~     used to obtain This blood from 30 term neonatal infants, ages 37 to 42 weeks Electrical~     stimulation will be applied at appropriate acupuncture points using a very low current for 10~     minutes, routine for procedural pain. The response to pain will be assessed using pain scales~     and physiologic changes.~      The investigators hypothesize that the NESAP procedure is safe in newborn infants undergoing~     a routine heelstick.~   "
158205|NCT01495273|"~     Various medical procedures require different objects to be inserted into the airway; for~     example, a bronchoscope - a fibreoptic camera device - can be guided down the windpipe to~     gain real-time images of the airway. Since inserting objects down the throat is uncomfortable~     for most patients, doctors have several options, one of which is putting the patient to sleep~     using general anesthetic before inserting something into the windpipe. This may not always be~     the best option, especially in cases where the patient needs to be awake during the~     procedure. In these cases, the doctor may 'freeze' the windpipe before inserting a scope or a~     tube into the airway. For this, the doctor inserts a needle through the front of the neck and~     injects local anesthetic. Inserting a needle into the windpipe comes with some risks to the~     patient, and the doctor wants to avoid puncturing nearby structures, such as arteries, veins,~     and the esophagus. The investigators have come up with a new method for accurately guiding a~     needle into the airway that will alert the user when they have successfully placed the needle~     tip in the windpipe. The investigators hypothesize that this new method will prove to be~     beneficial to clinicians and emergency medical personnel who need a fast, easy, and reliable~     way to insert a needle into the airway.~   "
158206|NCT01495260|"~     X-linked adrenoleukodystrophy is a rare, demyelinating and neurodegenerative disorder, due to~     a loss of function of a fatty acid transporter, the peroxisomal ABCD1protein. Its more~     frequent phenotype, the adrenomyeloneuropathy in adults, is characterized by axonal~     degeneration in spinal cord, spastic paraparesis and a disabling peripheral neuropathy.~     Actually, there is no efficient treatment for the disease. Our work in the last twelve years~     dissecting the physiopathological basis of the disorder has uncovered an involvement of the~     oxidative stress early in the neurodegenerative cascade. In a preclinical trial we have~     identified an antioxidant cocktail that efficiently reverse the clinical symptoms and the~     axonal degeneration in the mouse model for the disease. We propose the translation of the~     results to an open trial to test the tolerance and effectiveness of these drugs in the~     correction of the previously identified oxidative lesion biomarkers, as a first step to a~     randomized versus placebo, multicentric and international trial. You will be clinically~     explored and assessed in the Hospital Universitari of Bellvitge (HUB) using clinical scales~     for spasticity, disability, electroneurogram and cranial and spinal Nuclear Magnetic~     resonance (NMR). The information will be collected in a data base that will be of great value~     to improve the present attention and the future follow-up to facilitate your inclusion in~     therapeutic randomized, double blind, against placebo clinical trials.~   "
158207|NCT01495247|"~     This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients~     that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase~     Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the combination therapy of~     BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian model. When MTD/ RP2D is~     established the second part (phase II) will start. Phase II will evaluate the efficacy and~     the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid.~   "
158208|NCT01495234|"~     This study is designed to generate data relating to patient safety, bone generating activity~     associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate~     the feasibility of conducting a larger clinical trial in a patient population requiring~     spinal fusion.~   "
158209|NCT01495221|"~     This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal~     aflibercept injection in patients who have been previously treated for AMD and have~     persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.~   "
158210|NCT01495208|"~     This is an open label study to evaluate the efficacy of intravitreal aflibercept injection~     2mg in patients with a persistent FVPED despite at least 6 consecutive injections with~     ranibizumab 0.5 mg.~   "
158211|NCT01495195|"~     No medications are currently available for treatment of psychostimulant addiction, a~     compulsive preoccupation with use of cocaine and related compounds. Donepezil is a medication~     that is currently prescribed for Alzheimer's disease, and selegiline is a medication used for~     treatment of Parkinson's Disease. Both of these medications can decrease the amount of~     cocaine injections that laboratory animals choose to inject by vein. This project will~     determine if combined treatment with donepezil and selegiline can also decrease~     cocaine-motivated behavior for human subjects in a laboratory setting.~   "
158212|NCT01495182|"~     The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in~     healthy, adult volunteers.~   "
158213|NCT01495169|"~     Tolerability, undertstanding of the action of the drug in the body, and understanding the~     effect of the drug in adolescent patients needing treatment with an antipsychotic medication~   "
158214|NCT01495156|"~     The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial~     comparing two treatment strategies in adolescents with mania and prominent psychotic~     features. One group will receive a second generation antipsychotic (SGA) and placebo and the~     other will receive a SGA and lithium.~      The primary double-blind phase of the study will last 8 weeks, followed by a 24-week~     extension-phase.~   "
158413|NCT01492543|"~     The purpose of this study is to assess the effectiveness and safety profile of Aiyi®(Tegafur~     Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female~     patients with advanced metastatic breast cancer.~   "
158221|NCT01495065|"~     This is a two-part study. Part A is a three-period study in approximately 24 healthy male~     Japanese and Caucasian subjects. Period 1 and Period 2 will be an open label study to~     investigate the safety, tolerability, and pharmacokinetics of single ascending intravenous~     doses of GSK2251052. Period 3 is a single blind, placebo controlled, repeat fixed dose design~     to evaluate the safety, tolerability and pharmacokinetics of multiple intravenous doses of~     GSK2251052 for 12 days. The selection of the repeat IV dose will be based on the results from~     Periods 1 and 2. Japanese subjects will be stratified based on their metabolic genotype,~     polymorphic or wild-type for ADH and ALDH. Caucasian subjects are not anticipated to have~     these enzyme polymorphisms and therefore will not be stratified.~      Part B is a two cohort, single-blind, randomized, placebo-controlled, dose-rising, repeat~     dose study in approximately 24 healthy male and female subjects to evaluate the safety,~     tolerability, and pharmacokinetics of supratherapeutic IV doses of GSK2251052 for 10 days.~     Cohort 1 subjects will be randomized to receive 2250 mg of GSK2251052 or placebo and Cohort 2~     subjects will be randomized to receive 3000 mg GSK2251052 or placebo. The decision to conduct~     Cohort 2 of Part B will be based on the available toxicology cover results from ongoing~     preclinical toxicity studies.~   "
158222|NCT01495052|"~     Dietary modification is of great essential for the prevention and treatment of type 2~     diabetes mellitus. Common oat (Avena sativa L.) and its products showed a great potential~     benefits on NCDs including type 2 diabetes mellitus. But data about such effects of naked oat~     (Avena nuda L.) is still unavailable. The investigators aimed to examine the effects of~     organic naked oat with whole germ (ONOG) plus diet on patients with type 2 diabetes.~      After a pre-study with healthy adults, a randomized, single-blinded, multi-arm parallel trial~     of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes.~     Participants would be randomly assigned to one of the four following groups: usual care group~     (only basic health advice, no other interventions), diet group (systematic education,~     structured dietary), 50g-ONOG plus diet group (all the interventions of diet group plus~     replacement of 50g ONOG per day) and 100g-ONOG plus diet group. A regular follow-up for years~     would be carried out to predict the long-term effects of ONOG plus diet intervention on~     patients with type 2 diabetes.~      The investigators hypothesized that ONOG combined with diet would have better effects on~     glycaemia and insulin resistance control in addition to those yielded by diet or usual care.~   "
158223|NCT01495039|"~     Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida~     colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is~     still a matter of debate.~      Methods. Randomized, single-center trial studying single drug (nystatin) versus control in~     surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU~     admission (T0) and subsequently every 3 days (T3, T6, T9…). The primary evaluation criterion~     was the time course of colonization index (CI) during ICU stay.~   "
158224|NCT01495026|"~     This study is an open-label, randomized, single dose, multi-stage, cross-over study in~     healthy male subjects of North East Asian ancestry. The aims are to:~        -  evaluate the pharmacokinetic parameters of several formulations of a fixed dose~          combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg)~          relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin~          hydrochloride 0.2 mg tablets in the fasted state in order to define a formulation which~          is bioequivalent to a 0.2 mg orally disintegrating tamsulosin tablet, (Harnal-D Tablets)~        -  determine the effect of food on the relative bioavailability of tamsulosin in the FDC~          product which is assessed to be bioequivalent to Harnal-D Tablets in the fasted state~        -  assess the effect of water on the relative bioavailability of tamsulosin in Harnal-D~          Tablets in the fasted state~        -  assess the safety and tolerability of dosing with the different FDC capsule formulations~          Subjects will receive single oral doses in at least one treatment period; treatment~          periods will be separated by a 5-10 day washout period. Blood samples for~          pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be~          assessed by measurement of blood pressure, heart rate and review of adverse events. Each~          stage of the study will enrol 18 subjects to ensure 16 complete. Subjects may consent to~          participate in more than one stage.~   "
158225|NCT01495013|"~     The aim of this 20 week study is to show that glimepiride/atorvastatin fixed dose combination~     tablet is safe and as effective as atorvastatin + glimepiride combination taken as separate~     tablets, in improving glycaemic control (glycated haemoglobin, HbA1c) and cholesterol levels~     (Low-density lipoprotein, LDL) in diabetic subjects, who are inadequately controlled on a~     stable dose of metformin. Eight dose combinations will be included.~   "
158226|NCT01495000|"~     The purpose of this study is to determine if denosumab is effective in increasing bone~     mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.~   "
158227|NCT01494987|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to~     determine the effect of ranolazine when added to glimepiride on glycemic control in adults~     with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current~     treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise.~   "
158228|NCT01494974|"~     The purpose of this study is to compare the success rates and complications of two models of~     Ahmed glaucoma implants (FP7 and FP8) in patients with pediatric glaucoma.~   "
158229|NCT01494961|"~     ANRS 12127 Prenahtest is an intervention trial conducted in four countries (Cameroon,~     Dominican Republic, Georgia and India), where pregnant women are randomized during prenatal~     care to receive either standard post-test HIV counseling, or an innovative intervention~     called couple-oriented post-test HIV counseling (COC).~      The aim of the COC intervention is to empower women to communicate with her male partner~     about HIV, and HIV testing in particular, and encourage him to return for HIV testing and/or~     couple HIV counseling (where both couple members are counseled together).~      Prenahtest is the first randomised trial testing a prenatal intervention to increase partner~     HIV testing.~   "
158230|NCT01494948|"~     The purpose of this study is to determine if a certain cell type (the CD49d+ neutrophil) is~     associated with the presence or development of allergic disease.~   "
158315|NCT01493817|"~     This research study is studying biomarkers in tissue samples from younger patients with Wilms~     tumor. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how patients respond to treatment~   "
158231|NCT01494935|"~     The investigators will determine whether people with high muscle mitochondrial capacity~     produce higher amount of reactive oxygen species (ROS) on consuming high fat /high glycemic~     diet and thus exhibit elevated cellular oxidative damage. The investigators previously found~     that Asian Indian immigrants have high mitochondrial capacity in spite of severe insulin~     resistance. Somalians are another new immigrant population with rapidly increasing prevalence~     of diabetes. Both of these groups traditionally consume low caloric density diets, and the~     investigators hypothesize that when these groups are exposed to high-calorie Western diets,~     they exhibit increased oxidative stress, oxidative damage, and insulin resistance. The~     investigators will compare Somalians and NE Americans who are matched for age, BMI, and sex.~     The investigators will measure ROS production in skeletal muscle following high fat/high~     glycemic diet vs. healthy diet. The investigators will compare the oxidative damage to~     proteins, DNA, and lipids in these two populations following 10 days of high fat/high~     glycemic index diet in comparison with low fat diet. The investigators will determine if~     elevated levels of oxidative damage in Somali immigrant populations is accompanied by high~     mitochondrial capacity, higher ROS-emitting potential, and lower insulin sensitivity than NE.~     The proposed study will be performed utilizing the state-of-the-art proteomic and metabolomic~     methods many of which were recently developed in our laboratory. The investigators expect the~     results from this study to provide seminal insights into the underlying mechanism of insulin~     resistance and type 2 diabetes, in addition to demonstrating mechanisms by which a functional~     proteome is maintained in vivo.~   "
158232|NCT01494922|"~     The purpose of this study is to provide subjects who participated in prior studies of EXC 001~     the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.~   "
158233|NCT01494909|"~     Malnutrition is a significant problem in children and adults with Cystic fibrosis (CF). An~     impaired intestinal digestion and absorption capacity is one of the main factors responsible~     for the malnutrition in CF. This impairment starts early in life, leading to malnutrition,~     muscle weakness, impaired immune and lung function associated with poor prognosis. As low BMI~     and body weight is strongly associated with morbidity and mortality, a reduction in weight~     loss in CF and its manifestations would save the healthcare system substantially per year.~     Simple methods to measure the digested portions and utilization of nutrients and the~     effectiveness of pancreatic enzyme preparations and medications in CF are not available.~     Developing a panel of methods to accurately measure gut digestion, absorption and function~     will lead to studies optimizing nutritional regimen and pancreatic enzyme replacement therapy~     in CF. Furthermore, it will provide detailed insight in the disease and age related~     mechanisms of gut dysfunction in CF. Finally, it will provide required information that will~     lead to implement new strategies to improve gut health in order to enhance nutritional~     status, quality of life and survival.~      The hypothesis is that intestinal macronutrient digestion, absorption and function in CF can~     be quantified by an innovative panel of methods using stable isotopes. With this panel of~     methods, information can be obtained on the effect of disease progression on lipid, protein~     and glucose digestion and absorption and on gut function in CF as well as in other diseases~     and conditions characterized by a compromised gut. Furthermore, the optimal nutritional~     regimen and pancreatic enzyme therapy if applicable can be evaluated in these diseases. In~     the present study the investigators will study: 1. Pediatric patients with CF at Arkansas~     Children's Hospital; 2. Adult patients with CF at University of Arkansas for Medical~     Sciences. 3. Healthy control subjects. Diagnosis of CF is made based on universal diagnostic~     criteria. All CF patients are characterized by abnormal lipid digestion based on clinical and~     or laboratory (72 hour fat analysis or fecal elastase measurement) diagnosis, and requiring~     pancreatic enzyme replacement therapy, and no presence of unstable metabolic diseases.~     Additional criteria for the CF pediatric inpatients are: admitted to ACH for treatment of~     exacerbations of CF disease, clinically stable. The CF outpatients are stable outpatients~     with pancreatic insufficiency.~   "
158234|NCT01494896|"~     The purpose of this study is to see how inhaled treprostinil sodium (Tyvaso) affects the~     amount of air and blood that reach the alveoli, or tiy air sacs, in the lungs of patients~     with Group 1 Pulmonary Arterial Hypertension with concomitant Chronic Obstructive Pulmonary~     Disease (COPD).~   "
158235|NCT01494883|"~     The aim of the current study is to examine the (cost)effectiveness of mindfulness based~     stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer~     and their partners.~   "
158236|NCT01494870|"~     The primary objective of this study is to propose new treatment algorithm (strategy) for~     patients with Acute Coronary Syndrome (ACS) and left bundle-branch block (LBBB).~   "
158237|NCT01494857|"~     The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a~     fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with~     ulcerative colitis (UC) naive to treatment with biologics.~   "
158238|NCT01494844|"~     This research study will test the comfort of two noninvasive respiratory monitoring sensors~     (the connection to a monitor worn by a person—not the monitor). The two sensors, Masimo~     Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by~     the U.S. Food and Drug Administration (FDA) and currently used in the clinical setting.~     People who enter into the study will wear the two interfaces, one after the other, for 20~     minutes each (10 minutes with a small flow of air to the nostrils and 10 minutes without) and~     rate the comfort of each with a seven question survey. A total of 30 participants will be~     recruited.~   "
158239|NCT01494831|"~     The purpose of this study is to evaluate, in a randomised control trial (RCT), the~     effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing~     psychological distress in former child soldiers and other war-affected children in the~     Democratic Republic of Congo (DRC).~   "
158240|NCT01494818|"~     The purpose of this study was to assess and compare the effect of the repeated usage of two~     different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting~     system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with~     silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific~     aspect of interest was the effect on the ocular tissue, in particular the eyelids and their~     associations with the contact lens surface wettability and surface contamination.~   "
158241|NCT01494805|"~     The study will involve approximately 40 subjects aged 55 or above who have exudative~     age-related macular degeneration (wet AMD). Patients will be randomized to receive one of two~     doses of rAAV.sFlt-1 or assigned to the control group.~   "
158242|NCT01494792|"~     The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and~     Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of~     Group A Streptococcus when compared to culture.~   "
158243|NCT01494779|"~     The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic~     effect between two preparations of somatropin (T and C) after a single administration of 5 mg~     in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h,~     AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1~     presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).~   "
158244|NCT01494766|"~     Tyrosine is a non essential amino acid that is the precursor of the neurotransmitter,~     dopamine. Tyrosine is converted into Levodihydrophenylalanine (L-Dopa) and L-Dopa is~     subsequently and avidly converted into dopamine. It is well known that dopamine deficiency~     leads to the manifestations of restless legs syndrome (RLS). Studies have shown dopamine~     agonists and L-dopa to be effective in controlling symptoms. No studies to date have been~     done to determine the role of tyrosine in RLS. This open-label pilot study aims to determine~     the efficacy and tolerability of tyrosine in RLS, as current agents have limitations in~     treating RLS in addition to adding another possible agent to the investigators arsenal of~     treating RLS that maybe more cost efficient. In this pilot study, the dose of tyrosine will~     be escalated from 750 mg once daily by mouth (PO) up to 3000 mg once daily PO, as tolerated,~     in increments of 750 mg every week in patients who meet the inclusion criteria for RLS.~     Patients' symptoms will be monitored on a weekly basis for six weeks.~   "
158245|NCT01494753|"~     The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345~     versus an active comparator.~   "
158246|NCT01494740|"~     The aim of this study is to investigate the immunogenicity and safety of the inactivated~     split-virion vaccine in infants.~   "
158247|NCT01494727|"~     The objectives of this study are:~        -  To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge~          10/160mg after a single oral administration in healthy male volunteers~        -  To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis~          Exforge 10/160mg after a single oral administration in healthy male volunteers~   "
158248|NCT01494714|"~     The purpose of this study is to evaluate skin irritation and photo irritation of JNJ~     10229570-AAA on intact skin of Japanese healthy male participants.~   "
158249|NCT01494701|"~     This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics~     of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with~     Spinal Muscular Atrophy (SMA).~   "
158250|NCT01494688|"~     This open-label, multicenter, dose-escalation study will assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics of RO5509554 in participants with advanced solid tumors~     which are not amenable to standard treatment. In Part I (Dose Escalation), multiple ascending~     doses of RO5509554 will be administered as monotherapy in participants with solid tumors.~     Participants with locally advanced and/or metastatic ovarian (including fallopian tube) and~     breast carcinoma will receive multiple ascending doses of RO5509554 in combination with~     paclitaxel. In Part II (Expansion Cohort), RO5509554 will be administered as monotherapy to~     participants with locally advanced and/or metastatic Pigmented Villonodular Synovitis~     (PVNS)/Tenosynovial Giant Cell Tumor (TGCT), soft tissue sarcoma or malignant mesothelioma,~     ovarian (including fallopian tube), endometrial or breast cancer and pancreatic cancer.~     Participants with Human Epidermal Growth Factor Receptor 2 (HER2)/neu negative breast cancer~     will receive RO5509554 in combination with paclitaxel. Anticipated time on study treatment is~     until disease progression, unacceptable toxicity, death or participant refusal, whichever~     occurs first.~   "
158251|NCT01494675|"~     Recently, biomarkers like procalcitonin have been studied in order to help physicians to~     decrease the duration of the antibiotic therapy. The investigators objective was to assess~     whether the decrease in procalcitonin levels could be used to reduce the antibiotic therapy~     in critically ill patients with a proven infection without risking a worse outcome.~   "
158252|NCT01494662|"~     The purpose of this research study is to determine how well neratinib works in treating~     breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that~     may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a~     family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2).~      In this research study, the investigators are looking to see how well neratinib works to~     decrease the size of or stabilize breast cancer that has spread to the brain. The~     investigators are also looking at how previous treatments have affected your thinking (or~     cognition) and how much neratinib reaches the central nervous system.~   "
158253|NCT01494649|"~     A pilot study to determine the ability of a stannous fluoride containing toothpaste to~     provide immediate and short term relief from dentine Hypersensitivity compared to a control~     toothpaste.~   "
158254|NCT01494636|"~     This is a First Time in Human (FTIH) study for the sodium channel inhibitor, GSK2339345. The~     study is split into two parts. Part A will assess the safety and tolerability of the new~     drug. Part B will assess safety and tolerability as well as the effect of GSK2339345 on~     induced cough.~   "
158255|NCT01494623|"~     Deficits in working memory (WM) performance are the most significant cognitive impairments in~     schizophrenia (SCZ). It has also been shown that WM performance is contingent on the cortex~     synchronization, a process that relies on brain inhibition. Repetitive Transcranial Magnetic~     Stimulation (rTMS) has been demonstrated as an effective treatment for patients with SCZ and~     has been shown to increase brain inhibition and improve cognitive performance. In this study~     the investigators intend to:~        -  evaluate rTMS as a treatment for WM deficits in SCZ~        -  evaluate rTMS as a method to increase WM performance in healthy individuals~        -  determine if improvements in WM performance are related to enhanced synchronization of~          brain networks~        -  determine whether genetic polymorphisms predict cortical function and treatment response~        -  evaluate the influence of rTMS treatment on brain structure.~   "
158271|NCT01494415|"~     Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based~     paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer,~     especially for squamous cell cancer. The regimen of weekly nab-paclitaxel, carboplatin and~     concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel,~     carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung~     cancer may have promising result.~   "
158272|NCT01494402|"~     The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered~     ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK)~     of D961S, esomeprazole and buffered ASA following repeated administration in healthy male~     Japanese subjects.~   "
158326|NCT01493674|"~     The aim of this study was to determine the effect of folic acid supplementation on~     homocysteine levels in a group of patients with eating disorders (ED) with low folate intake.~     The secondary aims were to evaluate the evolution on cognitive and depressive status after~     the intervention.~   "
158256|NCT01494610|"~     This is a comparative bioavailability study to compare the pharmacokinetics and~     pharmacodynamic effects of Fluticasone propionate and Salmeterol delivered in a capsule-based~     inhaler versus a multi-dose dry powder inhaler in patients with moderate asthma and in~     patients with moderate to severe Chronic obstructive pulmonary disease (COPD).~      Co-primary endpoints will be the area under the curve (AUCτ) measured for plasma Fluticasone~     propionate (pharmacokinetic) and the pharmacodynamic effects of Fluticasone propionate~     (weighted mean serum cortisol over 0-12h) on the last day of each 10 day study treatment~     period. Secondary endpoints will include the following pharmacokinetic parameters for both~     fluticasone propionate and salmeterol: AUClast, AUC(0-t), Cmax, Cmin, tmax, λz, and t1/2 as~     well as the pharmacodynamic effects of salmeterol (pulse rate, blood pressure,~     electrocardiogram [ECG], potassium and glucose) and Fluticasone propionate (urine cortisol~     levels). Safety (adverse events and laboratory abnormalities) will also be assessed as a~     secondary endpoint.~      The study is a randomised, double blind, double dummy, four-period cross-over study.~     Approximately 60 asthma or COPD patients will be randomised. Patients meeting eligibility~     criteria will receive Fluticasone propionate/salmeterol 250/50mcg bid, from a capsule-based~     inhaler and from a multi-dose dry powder inhaler for a period of 10 days each in a randomised~     order. All patients will receive treatment from each device twice. To maintain the double~     blind, each patient will receive active treatment and placebo at the same time from two~     separate devices.~   "
158257|NCT01494597|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of cyclosporine in healthy adult subjects.~   "
158258|NCT01494584|"~     This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of~     ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled~     partial onset seizures or Lennos-Gastaut syndrome.~   "
158259|NCT01494571|"~     The PharmaJet needle-free injection system is a consistent approach to delivering injectates~     into the dermal layer of the human skin for the purpose of vaccination or medication~     delivery.~   "
158260|NCT01494558|"~     Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard~     of care for patients with inoperable stage III NSCLC. The most common chemotherapeutic agents~     used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in~     conjunction with cisplatin or weekly paclitaxel and carboplatin. No randomized phase III~     trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen~     over another. The clinical trial is to compare radiotherapy concurrently with PE (etoposide~     and cisplatin) and PC (paclitaxel and carbplatin) for local advanced NSCLC (stage IIIA/IIIB).~     It is a randomized, multicenter, open labeled phase III clinical trial. All patients receive~     conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. The~     chemotherapy regimens are PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and~     36 29-33 ) and PC (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over~     30min weekly). The primary purpose is to evaluate objective response rate, complications,~     progression-free survival, overall survival. The second purpose is to evaluate quality of~     life and cost.~   "
158261|NCT01494545|"~     The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time~     contact lens wearers.~   "
158262|NCT01494532|"~     This is a double blind, fixed dose, parallel group study to characterize the dose response of~     ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's~     disease. The primary endpoint of this study, mean change from baseline in total awake time~     spent off' is the same endpoint as used in the ropinirole PR pivotal study for advanced~     Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg)~     with the 8mg, 12mg, and 16mg per day doses powered to detect a 1.7 hour difference in total~     awake time spent off compared with placebo. The dose of Ldopa will remain stable through~     the study, unless the subject experiences tolerability issues that require an L-dopa dose~     reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to~     approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid~     confounding the efficacy data. Clinical review of the primary and secondary endpoints will be~     performed in order to establish the lowest maximally effective therapeutic dose.~   "
158263|NCT01494519|"~     The purpose of this study is to compare the use of modern ring external fixation versus~     internal fixation for fracture stabilization of severe open tibia fractures.~   "
158264|NCT01494506|"~     The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil~     (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic~     pancreatic cancer patients who have progressed on prior gemcitabine based therapy.~   "
158265|NCT01494493|"~     The purpose of this clinical trial is to evaluate the implant (rhBMP-2/ACS/allograft bone~     dowel) as a method of facilitating spinal fusion in patients with degenerative disc disease.~   "
158266|NCT01494480|"~     Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis~     due to the continued loss of motoneurons that leads them to death in less than 5 years. No~     treatment has changed its natural history. Intrathecal injection of umbilical cord~     mesenchymal stem cells can secret trophic factors that keep the motorneurons functional. The~     investigators have designed a phase I/II clinical trial to check the feasibility of this~     approach in humans.~   "
158267|NCT01494467|"~     The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its~     vehicle when applied once daily, at bed time, during a 12 week period in subjects with~     Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.~   "
158268|NCT01494454|"~     This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal~     System in treatment of the patients with degenerative disc disease.~   "
158269|NCT01494441|"~     The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and~     rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to~     instrumented fusion with autograft in patients with symptomatic degenerative disc disease.~   "
158270|NCT01494428|"~     The purpose of this pilot clinical trial is to evaluate the device design as a method of~     facilitating spinal fusion.~   "
158337|NCT01493531|"~     This study will compare the serum uric acid lowering effects, clinical benefits, and safety~     of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who~     have had an inadequate response to allopurinol.~   "
158273|NCT01494389|"~     The purpose of this study is to explore the value of CD4+T lymphocyte subsets in cell~     immunity in the patients with sepsis.There are immunoparalysis in septic patients,the~     important player is the change of CD4+T lymphocyte,this immunoparalysis state contribute to~     the illness progress and outcome. Comprehend the change regularity of septic patients' cell~     immunity can guide fiter and correcter treatment.~   "
158274|NCT01494363|"~     1. Goals~           The primary goal of this phase II trial is to:~           evaluate the response rate of combination chemotherapy with Fluorouracil, Leucovorin,~          Oxaliplatin, and Irinotecan in patients with locally advanced or metastatic Biliary~          tract cancer as first-line chemotherapy~           Secondary goals are to:~           evaluate the treatment-related toxicities of this combination, investigate~          progression-free survival(PFS) and overall survival(OS) in this population~        2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase~          II trial according to the two stage testing design by Simon two-stage testing procedure~   "
158275|NCT01494350|"~     The U.S. Army has recently completed a Phase 3 clinical trial in Tunisia. This is an~     open-label single site trial designed to expand our safety database and capture additional~     efficacy (final clinical cure rate of an index lesion) of WR 279,396 Topical Cream in~     Tunisian subjects with non-complicated, non-severe Cutaneous Leishmaniasis (CL). Subjects~     will be patients who visit Ministry of Health sponsored clinics in Tunisia who present with~     at least one CL lesion that is ulcerated and amenable to topical treatment. Potential trial~     subjects will be consented and screened for eligibility including medical history, physical~     exam, lesion parasitology, and renal and liver function tests. If eligible for the study,~     subjects will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) (target n~     = 110). The cream will be applied topically to all CL lesions once daily for 20 days by an~     investigator or study nurse. If a subject develops a new lesion during the study, the new~     lesion may also be treated with the topical cream.~   "
158276|NCT01494337|"~     The investigators are now proposing to compare two laser techniques for treating Benign~     prostate hyperplasia (BPH); Holmium Laser Enucleation of the Prostate (HOLEP) versus~     (greenlight) XPS which is a recently available technology in our center and is more efficient~     hence our choice to include patients with any size prostate. This will confirm whether the~     two techniques are equivalent in efficacy and safety independent of size as well as cost. The~     two techniques are available world wide as standard of care~   "
158277|NCT01494324|"~     The purpose of this study is to see if the investigators can do some tests on tissue from the~     area of the ablation. The investigators want to know if a test can help predict whether the~     ablation worked.~      The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in~     the area treated by ablation. However, cancer cells may begin to grow in or near the treated~     area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy~     liver cells that just look different because of the ablation. The test the investigators will~     study should be able to tell us the difference.~   "
158278|NCT01494311|"~     Arterial catheterization is painful and is associated with patient stress and anxiety.~     Analgesia is usually provided by subcutaneous injection of local anesthetic. An alternative~     is topical anaesthesia, such as Rapydan which is a novel topical anesthetic patch containing~     70 mg each of lidocaine and tetracaine. We therefore tested the hypothesis that Rapydan patch~     analgesia is non-inferior to subcutaneous local anesthetic.~   "
158279|NCT01494298|"~     Compared to other races, African-Americans with type 2 diabetes have different cholesterol~     levels, specifically triglycerides and low density lipoprotein. Recent data has shown the not~     only are cholesterol levels important in determining the risk for cardiovascular disease, but~     the size of the cholesterol particles and surface proteins on the cholesterol particles are~     also important. The objective of this study is to determine if African-American males with~     diabetes have different particle size, surface proteins, and cholesterol genetic links than~     African-American male without diabetes and Caucasian-American males with and without~     diabetes.~      African-American males with type 2 diabetes and not taking lipid-lowering medications are the~     current target population.~      After obtaining an informed consent, a complete medical history will be obtained and subjects~     will be examined, noninvasively, for physical signs of elevated cholesterol levels.~     Afterwards, blood samples [one venous puncture, 6 tubes (21 mL total)] will be obtained.~     Blood samples will be coded, sent to Berkeley Heart Lab and/or Clinical Laboratory Services,~     and undergo genetic testing at Mercer University College of Pharmacy and Health Sciences.~      Confidentiality of the subjects will be explained in the consenting process to the subjects.~     All subject samples and information will be coded. Each subject will be given a subject~     number upon consenting and this will be used throughout the study. All pertinent information~     of the subjects will be listed under the designated number, but will not be associated with~     that patient.~   "
158280|NCT01494285|"~     This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group,~     ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with~     mild to moderate acne vulgaris.~   "
158281|NCT01494272|"~     Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It~     has been shown to be effective in managing postoperative pain in children undergoing~     abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown~     that children receiving caudal blocks have secondary benefits such as lower narcotic and~     anesthetic requirements, more rapid awakening from general anesthesia, decreased time to~     discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias~     et al 1995, Tobias 1996).~      This proposed study involves the use of a caudal block in children undergoing elective~     inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in~     pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a~     caudal block before the onset of a painful stimulus, we can decrease central nervous system~     sensitization and reduce postoperative analgesic requirements~   "
158301|NCT01493999|"~     MAIN AIM: To compare the pharmacological potency of administering adjusted 600 mg clopidogrel~     loading doses and 60 mg prasugrel in patients with high on-clopidogrel platelet reactivity~     (HPR) after PCI.~      SECONDARY OBJECTIVES: To define the optimal maintenance dose with both prasugrel (5 mg vs. 10~     mg) and clopidogrel (75 mg vs. 150 mg) in patients with HPR for chronic therapy.~      DESIGN: Prospective, Randomized, Open-label, Single-center trial.~      PRIMARY ENDPOINT: Platelet reactivity measured with Multiplate between clopidogrel and~     prasugrel arm at day 4.~   "
158282|NCT01494259|"~     This double-blind, randomized, controlled clinical trial comparing patient-reported pain and~     pain medication/narcotic use between patients randomized to treatment (bupivacaine) or~     placebo (saline) delivered via pain pump to the mastectomy site. Candidates will have chosen~     to have a mastectomy on one side immediately followed with tissue expander placement breast~     reconstruction.~      Patients will be randomized 1:1 to bupivacaine- (treatment) or saline-(placebo) filled~     percutaneously-placed pain pumps; neither the participants nor the study staff will know~     participants' treatment. Data on patient-perceived pain and pain medication use will be~     collected before surgery, during surgery, and after surgery on Days 1, 2, 3, 7, and 90, and~     at Years 2 and 4 by phone.~      The investigators hypothesize that patients randomized to the treatment (bupivacaine) group~     will have significantly lower pain scores and use less pain medicine than patients who~     receive placebo during the first 90 days following their surgery. The Year 2 and Year 4~     follow-ups are included as tertiary endpoints to capture differences in chronic pain, and~     patients will be asked to complete the same questionnaires as at the Day 90 follow up.~   "
158283|NCT01494246|"~     Objectives. To evaluate the effectiveness and cost effectiveness of clinical practice guide~     based intervention with two face-to-face visits and e-mail tracking compared to brief advice~     to obtain continued smoking abstinence at 6 and 12 months after intervention.~      Methodology. simple randomized controlled multicentric trial. All smokers (N=1064) aged 18 or~     older that attend by any reason to the primary care center and that have an e-mail account~     and they checked it at least once a week will be invited to participate. The enrolled~     participants will be randomly divided into control (N=532) and intervention group (N=532). An~     intensive intervention, based on the recommendations of the clinical practice guides, that~     will include six contacts (2 face-to-face and 4 by e-mail) will be applied to the~     intervention group. Control group will receive brief advice.~      The main dependent variable will be continued abstinence of tobacco consumption at six and~     twelve months after the beginning of the intervention which will be validated by and a carbon~     monoxide breathe analysis measured by a cooximeter in standard conditions. Secondary~     variables will include: stage change on the quitting smoking process and evaluation of the~     effectiveness on the reduction of the number of smoked cigarettes at six and twelve months~     after intervention. A descriptive analysis of all variables will be done. A multivariate~     analysis will be undertaken to assess differences among intervention and control group;~     logistic regression for dichotomic variables and lineal regression for continuous variables.~   "
158284|NCT01494233|"~     The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of~     dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).~   "
158285|NCT01494220|"~     Bispectral index (BIS) monitoring during living donor liver transplantation (LDLT) may be~     influenced with several factors rather than the depth of anesthesia such as bradycardia,~     hypotension, hypothermia, and mixed venous oxygen saturation (SvO2). The investigators tested~     the validity and the independent factors which may alter of BIS readings during LDLT.~      Up to the investigators best knowledge, the independent predictors for BIS monitoring were~     not identified yet during the three phases of liver transplantation.~   "
158286|NCT01494207|"~     The main aim of this study is to measure the effectiveness of a worksite health promotion~     programme on improving physical activity behaviour and associated biological risk factors for~     cardiovascular disease among South African employees at increased risk for cardiovascular~     diseases. Additionally, the investigators will conduct an economic evaluation to determine~     the associated cost- effectiveness of these health related interventions offered at South~     African companies.~      The investigators hypothesize that employees who receive the intervention counseling will~     have increased levels of physical activity and reduced risk for cardiovascular disease~     compared to those in the control group.~   "
158287|NCT01494194|"~     Air Structuring Protein (ASP) is a small protein derived from a fungus which is already~     widely used to produce enzymes that are added to foods. ASP has the possibility of~     stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential~     ice-cream ingredient.~      Toxicological tests have also been carried out to further confirm the safety of the material~     and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.~      As part of the safety evaluation of a new protein for use in foods, the potential~     allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect~     of ASP. This study will investigate:~        -  Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population~          of participants with proven sensitivity to mould.~        -  Whether ASP is responsible for any positive SPT reactions, should they occur.~        -  And if any positive SPT reactions to ASP occur, whether such reactions are clinically~          relevant with respect to food allergy.~      The study is divided in three stages. In Stage 1 and Stage 2, the SPT is open label, which~     means that both the participant and the study doctor will know which materials are being~     tested.~      In Stage 3, the food challenge has a crossover design, meaning that participants will take~     one of the products (ASP or placebo [food containing no ASP]) during the first half of the~     study and the other treatment during the second half. The order of ASP and placebo will be~     decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair~     as possible, the food challenge is double blinded. This means that neither the participant~     nor the study doctor will know which kind of products (ASP or placebo) the participant is~     taking.~      This is a multi centre study which is taking place in the UK.~   "
158288|NCT01494181|"~     Plan of investigation:~      This is an observational cohort study to determine the effect of OSA, independent of other~     risk factors, on postoperative vascular events. The study is conceived, designed and will be~     conducted, and analyzed independent to any company. There is no commercial sponsorship.~   "
158302|NCT01493986|"~     Systemic LA toxicity is an important complication of regional anesthesia. Lowering the LA~     dose is one of the strategies to reduce this risk. For upper limb blocks it is well~     documented that ultrasound guidance allows a significant lower dose of LA for interscalene~     and axillary blocks than with guidance by peripheral nerve stimulation. However, a~     corresponding difference has not yet been found for supraclavicular and infraclavicular~     blocks. The aim of the present study is to define the minimum effective volume of ropivacaine~     7.5 mg/ml when using the LSIB method.~   "
158303|NCT01493973|"~     Friedreich's ataxia (FRDA) is a rare genetic disorder characterised by severe neurological~     disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency.~     Although several drugs have been proposed, there is no available treatment. Four trials~     recently demonstrated that erythropoietin can increase the intracellular levels of frataxin.~     The present project is aimed at testing a long term therapeutic approach using~     erythropoietin, which is an already available and commercialised drug. The study will test~     the effect of erythropoietin on exercise capacity, which is reduced in patients with FRDA.~     Additional objectives of the study will be the drug's safety and tolerability, and its effect~     on frataxin, blood vessel reactivity, heart functional indexes, and disease progression.~   "
158289|NCT01494168|"~     Introduction:~      Obesity is a major public health problem, associated with many morbidities, including~     metabolic and cardiovascular disease (CVD). High blood pressure (hypertension) is the most~     common comorbidity and one of the major risk factors for CVD and kidney failure. It has been~     described an almost linear relationship between body mass index (BMI) and the level of blood~     pressure (BP), but the mechanisms underlying this relationship are complex and incompletely~     understood : activation of renin-angiotensin-aldosterone and sympathetic nervous systems,~     alterations in systemic hemodynamics and arterial parameters; a significant correlation~     between overall and / or visceral obesity and arterial stiffness assessed by carotid-femoral~     pulse wave velocity (PWV) has been observed.~      By its effectiveness in terms of magnitude and sustainability of weight loss, bariatric~     surgery is becoming increasingly important in the management of obesity and the prevention of~     its comorbidities. It reduces all-cause as well as CV mortality. Bariatric surgery allows a~     resolution of the metabolic syndrome (in 2 out of 3 patients) and diabetes (in 5 out of 6~     patients), but its effect on blood pressure remains inconstant and transient. The reasons for~     this limitation and the detailed effects of bariatric surgery on hemodynamics and arterial~     parameters have been poorly studied. Of note, a reduction in left ventricular hypertrophy, an~     improvement in diastolic dysfunction and aortic distensibility assessed by ultrasound or MRI~     have been observed.~   "
158290|NCT01494155|"~     A standard treatment for patients with pancreatic cancer is standard photon radiation in~     combination with the chemotherapy drug, capecitabine. In this research study the~     investigators are using standard photon radiation or a different type of radiation therapy~     called proton beam radiation and adding hydroxychloroquine to be used in combination with~     capecitabine.~      In this research study, the investigators are looking to determine if proton or photon beam~     radiation in combination with hydroxychloroquine and capecitabine is effective in controlling~     your cancer growth.~   "
158291|NCT01494142|"~     The purpose of this multi-center, clinical registry study is to determine genetic markers~     associated with susceptibility of AD patients to infections and to also serve as a potential~     participant database for future studies.~   "
158292|NCT01494116|"~     The purpose of this study is to determine the impact of syringe size on the amount of time it~     takes a health care provider to administer a known volume (900 mL) of resuscitation fluid to~     a non-clinical, toddler-sized, model. The investigators hypothesize that syringe size will~     impact fluid resuscitation time.~   "
158293|NCT01494103|"~     Patients will be receiving a stem cell transplant as treatment for their disease. As part of~     the stem cell transplant, patients will be given very strong doses of chemotherapy, which~     will kill all their existing stem cells.~      A close relative of the patient will be identified, whose stem cells are not a perfect match~     for the patient's, but can be used. This type of transplant is called allogeneic, meaning~     that the cells are from a donor. With this type of donor who is not a perfect match, there is~     typically an increased risk of developing GvHD, and a longer delay in the recovery of the~     immune system. Seventy to ninety percent of people who receive unchanged marrow or stem cells~     from this type of donor will develop severe GvHD.~      GvHD is a serious and sometimes fatal side-effect of stem cell transplant. GvHD occurs when~     the new donor cells (graft) recognize that the body tissues of the patient (host) are~     different from those of the donor. When this happens, cells in the graft may attack the host~     organs, primarily the skin, liver and intestines, causing severe rashes, diarrhea, liver~     disease, and even death. GvHD is caused by a type of immune cell in the graft called T cells.~      While this stem cell selection procedure will reduce the risk of GvHD, it will also result in~     slower recovery of the patient's immune system. As the immune system is responsible for~     fighting infections in your body, a longer recovery time after a transplant means that the~     patient may be at increased risk for infections which can become life-threatening. In some~     patients, the immune system can also fight leukemia cells and reduce the risk of relapse.~      In this study, investigators are trying to see whether they can make special T cells in the~     laboratory that can be given to the patient to help their immune system recover faster. As a~     safety measure, we want to program the T cells so that if, after they have been given to~     the patient, they start to cause GvHD, we can destroy them (suicide gene).~      Investigators will obtain T cells from a donor, culture them in the laboratory, and then~     introduce the suicide gene which makes the cells sensitive to a specific drug called~     AP1903. If the specially modified T cells begin to cause GvHD, the investigators can kill the~     cells by administering AP1903 to the patient. We have had encouraging results in a previous~     study regarding the effective elimination of T cells causing GvHD in vitro, whilst sparing a~     sufficient number of T cells to fight infection and potentially cancer.~      More specifically, T cells made to carry a gene called iCasp9 can be killed when they~     encounter the drug AP1903. To get the iCasp9 gene into T cells, we insert it using a virus~     called a retrovirus that has been made for this study. The drug (AP1903) that will be used to~     activate the iCasp9 is an experimental drug that has been tested in a study in normal~     donors with no bad side-effects. We hope we can use this drug to kill the T cells. Other~     drugs that kill or damage T cells have helped GvHD in many studies, but with a more profound~     reduction of immune defense. However, if the patient develops significant GvHD, they will~     also receive standard therapy for this complication, in addition to the experimental drug.~      The major purpose of this study is to find a safe and effective dose of iCasp9 T cells that~     can be given to patients who receive an allogeneic stem cell transplant. Another important~     purpose of this study is to find out whether these special T cells can help the patient's~     immune system recover faster after the transplant than they would have otherwise.~   "
158294|NCT01494090|"~     Statins (or HMG-CoA reductase inhibitors) have largely proven their efficacy in the primary~     and secondary prevention of cardiovascular events. Many clinical and experimental studies~     support also a potential beneficial effect of statin therapy on venous thromboembolism (VTE).~     Patients with hip fracture are at high risk of VTE and cardiovascular events.~      The aim of this study is to evaluate the efficacy and the tolerance of a statin~     (rosuvastatin) in hip fracture surgery on the occurrence of venous and atherothrombotic~     events and the global mortality at six months.~      Subjects aged 60 years or over who are scheduled to undergo surgery for fracture of the upper~     portion of the femur (hip fracture) are eligible to participate to this multicentre,~     randomized, double-blind placebo controlled trial. They will receive either rosuvastatin (5~     or 20 mg) or placebo for 6 months. The primary efficacy outcome is the incidence of an~     adjudicated composite of non fatal VTE, acute coronary syndrome, non fatal stroke, other~     acute ischemic arterial event, or all-cause death.~      Assuming a endpoint frequency of 20% in the control group, we calculated that 1200 patients~     will be required for the study to have 80% power to detect a 30% reduction in the relative~     risk with rosuvastatin (with a two-sided alpha level of 5%).~      The investigators assumed that rosuvastatin could have a positive benefit-risk ratio in~     patients undergoing orthopaedic surgery for hip fracture, by reducing vascular events and~     global mortality at six months.~   "
158295|NCT01494077|"~     The purpose of this research project is to determine if pancreatic cyst fluid can be diluted~     and provide an accurate Carcinoembryonic Antigen (CEA) level. The investigators hypothesis is~     that pancreatic cyst fluid obtained by EUS-FNA can be diluted effectively and accurately for~     the measurement of CEA levels.~   "
158296|NCT01494064|"~     This study seeks to assess the impact of the standardization of nursing supervision of~     patients with hepatic encephalopathy using a grid of appropriate surveillance for the~     prevention of complications in the ICU.~   "
158297|NCT01494051|"~     The study also determines if eating a diet higher in protein alters body composition, energy~     balance and metabolic control among patients with a long-chain fatty acid oxidation disorder.~   "
158298|NCT01494038|"~     Tuberculosis (TB) is a leading cause of death among HIV-infected persons in low-income~     settings and can be a serious complication for HIV-infected pregnant women and their infants.~     Isoniazid (INH) preventive therapy (IPT) is effective for HIV-infected adults, but the safety~     of IPT in pregnant women is unknown. This study will evaluate the safety of IPT among~     HIV-infected pregnant women.~   "
158299|NCT01494025|"~     Elevated fat levels within skeletal muscle cells (intramyocellular lipids) are highly~     correlated with muscle and whole-body insulin resistance, and more prevalent in obesity. The~     molecular links and metabolic shifts driving this association remain open to debate, but~     notably, reduced muscle mitochondrial fatty acid (FA) ß-oxidation is more prevalent among~     insulin-resistant/diabetic persons. Therefore, discovery of biomarkers reflective of the~     status of an individual's muscle FA ß-oxidation activity or capacity would have tremendous~     prognostic and diagnostic value in terms of diabetes. Furthermore, characterization of~     metabolites associated with muscle mitochondrial fat metabolism should uncover candidate~     signaling factors which tie FA ß-oxidation to insulin signaling. The investigators propose to~     identify, for the first time, specific biomarkers of muscle FA ß-oxidation using multiple~     metabolomic analytical platforms to compare metabolite profiles in samples derived from~     biological systems displaying disparate muscle fat combustion. The current experiment will~     test whether plasma metabolites and/or metabolite signatures that track efficient muscular FA~     ß-oxidation can be experimentally increased in obese, insulin-resistant subjects via a~     diet-exercise regimen designed to improve muscle fitness and FA combustion.~   "
158300|NCT01494012|"~     This phase I trial studies the side effects and the best dose of stereotactic body radiation~     therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary~     peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less~     damage to normal tissue.~   "
158305|NCT01493947|"~     Study objectives:~        -  To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream~          in subjects with papulopustular rosacea after 16-week topical treatment.~        -  And to compare, for subjects initially successfully treated by 16 weeks treatment,~          Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period~          by assessing, the time of first relapse, the relapse rate, and the number of days free~          of treatment~   "
158306|NCT01493934|"~     Insulin resistance, characterised by a depressed cellular sensitivity to insulin in~     insulin-sensitive organs, is a central feature of the metabolic syndrome. In people with no~     diabetes mellitus, the presence of metabolic syndrome leads to an increase of mortality,~     whatever the cause, but, as a majority, cardiovascular diseases.~      In patients with type 2 diabetes mellitus, the presence of a metabolic syndrome leads to an~     increase in major adverse cardiovascular events. The prevalence of metabolic syndrome is led~     to grow in a near future, because of the increase of diabetes mellitus and obesity~     prevalence.~      Actually, there is no simple tool to measure insulin resistance. The gold standard technique~     remains the hyperinsulinemic euglycemic clamp. However, the complexity and length of this~     technique render it unsuitable for routine clinical use. Many methods or index have been~     proposed to assess insulin resistance in human, but none have shown enough relevance to be~     used in clinical use.~      Within the investigators U877 INSERM team, the investigators previously performed in vivo~     biodistribution studies with 6-DIG (6-deoxy-6-iodo-D-glucose), a new tracer of glucose~     transport, radiolabelled with123 iodine, with and without insulin, on the one hand in~     genetically diabetic mice (db/db), consequently having a severe insulin resistance and in the~     other hand in rats with acquired insulin resistance after a fructose diet.~      The investigators have demonstrated that 6-DIG is able to identify in vivo slight glucose~     transport variations in insulin sensible organs. Then, the investigators developed a fast and~     simple imaging protocol with a small animal gamma camera, which allows the obtaining of an~     insulin resistance index for each organ, directly transferable to human.~      The investigators project is to transfer to human this measurement technique, perfectly~     validated in animal.~      The main goal of this monocentric phase I-II study is to evaluate the tolerance to the~     insulin resistance measurement technique with 6DIG scintigraphy, in healthy volunteers and in~     diabetic patients. The investigators plan to enrol 6 healthy volunteers and 6 type 2 diabetic~     patients.~      The investigators secondary goals will be to evaluate feasibility and reproducibility of the~     measurement technique, to follow pharmacokinetic and to assess efficacy of 6-DIG to measure~     insulin resistance.~   "
158307|NCT01493921|"~     Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate~     measured outcomes for skin lesion treatment. In addition to the high complete response rate~     (90.0%) as compared with the conventional therapy, the most significant result was that no~     undesirable side effects were associated with the use of SR-T100 gel. The result also shows~     approximately 80% of study subjects had a complete response in phase II clinical trial~     conducted in Taiwan; hence, result from our study model suggested SR-T100 gel offers~     beneficial therapeutic values in treatment of AK is harmless to the skin as well as high~     tolerance level displayed by majority of patients.~   "
158308|NCT01493908|"~     The efficacy of the placebo effect has been proved in many prior studies by comparing the~     symptoms and measures of patients. Placebo has been proved to help in treating illnesses such~     as depression, stomach ulcer and chronic headaches.~      A Meta analysis checked 47 studies about placebo and showed great significance when a patient~     is treated with placebo pill, no active substance, just by activating conditioning and~     expectation mechanism in his body, thus providing to the healing process, and that is it's~     importance.~      In recent years studies established a relationship between marketing variables (such as~     price, label) to the efficacy of a product. In addition- a unique research run in 2008 showed~     a significant relationship between the marketing strategies and the efficacy of medication;~     more specifically, patients in this research experienced less (controlled) pain when treated~     with placebo medication introduced to them as more expensive than patients treated with~     placebo medication that was introduced to them as much cheaper. All patients were treated~     with the exact same medication.~      In the investigator's experiment the investigators design a laboratory experiment to~     determine if marketing factors could invoke the placebo effects described earlier. For the~     initial laboratory experiment, we decided to examine the difference in price, on the efficacy~     of an OTC analgesic through the mediation of low- voltage electrical pulses to the patient's~     wrist.~      The investigators study hypothesis is that marketing variables such as price and brand name~     will affect the therapeutic efficacy of an analgesic, i.e. a medicine will have greater~     influence when the patient is aware of its price compared to one who is not.~   "
158309|NCT01493895|"~     For centuries, light has been a well-known and effective healing method. In the beginning of~     the 20th century there was a first attempt to condense light energy and distribute it in~     higher levels, a use that was successfully applied on many soldiers wounded in the Second~     World War. The laser, which is based on the quantum phenomenon of stimulated emission, was~     first demonstrated in the beginning of the 1960s and immediately received many applications~     in all areas of medicine.Many different studies were carried out in the past decade trying to~     assess the effect of laser therapy on properties of healing wounds. This study aim to assess~     the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of non-healing~     diabetic foot ulcers.~   "
158310|NCT01493882|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     JNJ-39758979 compared with placebo in patients with uncontrolled asthma despite current~     treatment with inhaled corticosteroids and/or long-acting beta 2-agonist (LABA) and/or~     montelukast for at least 4 weeks.~   "
158311|NCT01493869|"~     The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75~     mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another~     objective is to assess the safety and tolerability of cabozantinib in these adult subjects.~   "
158312|NCT01493856|"~     The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of~     combination of rosuvastatin and CS-866 and DWJ1276 alone.~   "
158313|NCT01493843|"~     This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the~     efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and~     without pictilisib in particpants with previously untreated advanced or recurrent non-small~     cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin~     (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous~     NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on~     study treatment is until disease progression or intolerable toxicity occurs. Participants in~     placebo arms with disease progression may cross over to open-label active pictilisib.~   "
158314|NCT01493830|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies biomarkers in tumor samples from younger patients with~     neuroblastoma.~   "
158316|NCT01493804|"~     Background:~      - Different regions of the brain are activated when a person performs a task.~     Electroencephalograms (EEGs) and near-infrared spectroscopy (NIRS) are tests that detect~     changes in the brain. EEG looks at changes in electrical signals, and NIRS looks at changes~     in blood flow. These tests can detect local changes in brain activity in a safe and~     noninvasive way. Researchers want to study brain activity more closely by combining these~     tests.~      Objectives:~      - To use EEG and NIRS to study brain activity during specific tasks.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have between one and five testing sessions. Each session will be 1 to~          2 hours long. The tests given at each session will be determined by the researchers.~        -  Participants will have EEG and NIRS tests, given either separately or together. During~          these tests, participants will perform tasks of thinking and reasoning.~        -  Participants may also complete optional tests of thinking and reasoning. These tests~          will be given on paper or on a computer.~   "
158317|NCT01493791|"~     Background:~      - CDB-2914 is a hormone that blocks progesterone, which is necessary for maintaining~     pregnancy. In women with fibroid tumors, CDB-2914 shrank the tumors. In many cases, menstrual~     periods stopped during treatment. Because CDB-2914 decreased or stopped menstrual bleeding in~     women with fibroids, it may be able to treat abnormal periods in women without fibroids.~      Objectives:~      - To see whether CDB-2914 can treat abnormal uterine bleeding in premenopausal women.~      Eligibility:~      - Premenopausal women who have abnormal uterine bleeding that is not caused by fibroids.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests. An ultrasound with fluid of the uterus will test for~          fibroids. Uterine cells will be collected for biopsy.~        -  For the next three menstrual cycles, participants will take either CDB-2914 or a~          placebo. Treatment will be studied with blood tests and symptom diaries.~        -  At the end of the treatment, participants have three options. They can have surgery at~          the Clinical Center or have another 3 months of CDB-2914. The third option is to stop~          treatment at the Clinical Center.~        -  Surgery will be either uterine ablation or hysterectomy. Only women older than age 33~          may have a hysterectomy. Blood and urine samples will be collected after surgery.~        -  Both surgery and further treatment participants will have followup exams.~        -  All participants will have a final followup exam 1 year after stopping treatment.~   "
158318|NCT01493778|"~     This trial is conducted in Asia, Europe and North America. The purpose of the trial is to~     evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in~     previously untreated children with haemophilia A.~   "
158319|NCT01493765|"~     The goal of this project is to improve the efficiency of training and assessment of technical~     skill in surgical treatment of otologic disease. Through previous funding, we have developed~     an intuitive virtual simulation environment to be used as an adjuvant for teaching temporal~     bone surgery. Using direct-volume visualization techniques with integrated stereoscopic~     display, haptic (force) feedback, and aural simulation, we have achieved a straightforward,~     low-cost learning environment ready for translation into a practical training and assessment~     tool. This application challenges and seeks to shift current practice in clinical training by~     translating the simulation environment into a vehicle for curriculum development, technical~     skills assessment, and dissemination. The intent is to provide more accessible, inexpensive,~     safe, and deliberate practice with objective and continuous quantitative, objective~     assessment in the early stages of training.~   "
158320|NCT01493752|"~     Diets rich in fruit and vegetables reduce the risk of strokes and heart attacks, however the~     exact cause of this beneficial effect is uncertain. Evidence suggests that certain~     vegetables, including beetroot and the green leafy vegetables, possess high inorganic nitrate~     concentrations. The investigators recent evidence suggests that inorganic nitrate provides a~     source of gas called nitric oxide in the body that exerts a number of beneficial effects upon~     the heart and blood vessels . The investigators have previously shown that beetroot juice~     ingestion improves blood vessel (vascular endothelial) and platelet function in healthy~     volunteers. Studies by the investigators show that these effects are due to conversion of~     nitrate to nitrite by symbiotic (helpful) bacteria (located on the tongue) and subsequent~     conversion of nitrite to nitric oxide in blood vessels. The investigators now wish to explore~     whether dietary nitrate, via its beneficial effects on platelets and blood vessels, might~     improve indices of atherosclerotic disease progression in high risk individuals~     (hypercholesterolemics). Recruits will have high cholesterol and no known atherosclerosis and~     will not yet be on any anti-cholesterol medications. Volunteers will consume a daily dose of~     beetroot juice or placebo nitrate-free juice for six weeks. Vascular function will be~     assessed using non-invasive techniques at the beginning and at the end of the study using~     ultrasound measurement of flow mediated dilatation (FMD) of the brachial artery in the arm~     and pulse wave analysis (PWA) and pulse wave velocity (PWV) to measure arterial compliance.~     To assess impact on platelet function, blood samples will also be taken at the start and at~     the end of the study.~   "
158321|NCT01493739|"~     This study aims on the combinatorial results of cytology, histopathology and microbiology~     obatined by EBUS-TBNA for unselected mediastina lesions.~   "
158322|NCT01493726|"~     This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072~     (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.~   "
158323|NCT01493713|"~     The purpose of this study is to to evaluate the correlation of overall objective response~     according to RECIST v1.1. criteria evaluated by conventional imaging techniques, morphologic~     response by CT, and histopathologic response in patients with resectable hepatic metastasis~     secondary to colorectal cancer treated with bevacizumab in combination with XELOX.~   "
158324|NCT01493700|"~     The purpose of this study is to compare the effect of electrically heated humidifier on the~     body temperature during shoulder arthroscopy.~   "
158325|NCT01493687|"~     The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its~     vehicle when applied once daily, at bed time, during a 12 week period in subjects with~     Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.~   "
158338|NCT01493518|"~     The purpose of this study is to study the safety, tolerability and immunogenicity of AMG 557~     following multiple subcutaneous dose administration in adults with moderate to severe~     psoriasis.~   "
158327|NCT01493661|"~     Sleep is a physiological state considered essential for health and human survival. The~     prevalence of chronic sleep restriction has increased in modern society, as well as the~     effects of the same health concerns about various aspects, including the physiological and~     neurobehavioral. The objective of this study is to identify the neurobehavioral and~     physiological responses of healthy men with different needs of total sleep time (TST)~     submitted to chronic sleep restriction. Participants in this study will be 30 male~     volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with~     TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7~     and 8h. The TST will be established by the constant and continuous use of actigraphy for 10~     days prior to the onset of the experimental protocol. All volunteers will undergo medical and~     polysomnography (PSG) examination to detect the presence or not of changes in sleep as well~     as other health problem that prevents their participation in the study. The experimental~     protocol consists of a basal night of sleep, five consecutive nights of chronic sleep~     restriction to 25% of TST in the beginning night and a night of recovery, which will be~     allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up in~     each day, the volunteer will undergo tests to assess the physiological and neurobehavioral~     variables. The significance level will be 5% (p ≤ 0.05).~   "
158328|NCT01493648|"~     This proposal will explore muscle function (strength and endurance) in men and women~     suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle~     symptoms will be explored. Also, the investigators will assess the potential usefulness of~     vitamin D supplementation in a randomized control trial.~   "
158329|NCT01493635|"~     The World Health Organization analgesic ladder for cancer pain relief is an internationally~     used approach to managing cancer pain. Patients generally start on Step 1 of the ladder~     (paracetamol). As pain increases or is not well controlled on this, they progress to Step 2~     which involves a stronger pain killer (weak opioid such as codeine). If pain is still not~     controlled they progress to Step 3 of the ladder which is a strong opioid (such as morphine).~     Work to date has suggested that Step 2 may be unnecessary and most patients usually require~     Step 3 analgesia. The TVT trial aims to examine the standard approach (Step 1-Step2-Step-3)~     versus a two step approach (Step 1-Step 3).~   "
158330|NCT01493622|"~     The purpose of this study is to determine whether minocycline are effective in the treatment~     of negative and cognitive symptoms in schizophrenia.~   "
158331|NCT01493609|"~     The CLICK-EAST research project is an investigation of the efficacy of a computer based~     learning programme which aims to teach the fundamental components of social attention to~     young children with autism spectrum disorder (ASD). Social attention describes the process~     of choosing to look at or listen to social information in the world, normally in preference~     to any other available information. Social information normally refers to people: for~     example, we notice human voices more than birdsong or traffic noise, even if the latter is~     louder. As a rule, children with ASD are less likely to prioritise this kind of social~     information. This is thought to have a significant effect on their development and behaviour.~     For example, a child who doesn't listen to what his parents say may be very slow to learn~     language, and may also fail to follow important instructions. Our goal is to create a new~     learning programme, in the form of an enjoyable computer game, which encourages children to~     practise the skills of looking at and listening to people, despite the presence of~     distracting information. The investigators will develop the game with the input of an~     advisory group of parents and teachers of children with ASD as well as some young adults with~     an ASD diagnosis. Then they will perform a trial of the game with a group of preschoolers~     with ASD and their families, in order to determine whether the game is having a positive~     effect on the children's abilities.~   "
158332|NCT01493596|"~     Primary Objective:~      • To evaluate the safety and tolerability of ascending single oral doses of CPP-115~      Secondary Objective:~      • To determine the pharmacokinetic profiles of CPP-115 following administration of a~     ascending single oral doses~   "
158333|NCT01493583|"~     Recent evidence has pointed to distinct alterations of brain functions in obese subjects some~     of which may even be causative for their obesity. The objective of this study was to examine~     food and non food related alterations in brain functions after excessive weight loss due to~     Roux-en Y gastric bypass surgery (RYGB), one of the most successful therapeutic approaches~     for long lasting weight loss. The investigators hypothesized that obese as compared with lean~     women show an altered activation pattern in the brain areas involved in the homeostatic~     regulation of eating behavior, i.e. the hypothalamus, in reward-related brain areas, such as~     the orbital frontal cortex (OFC) and the striatum as well as in prefrontal inhibitory control~     areas. Furthermore, the investigators hypothesized that women who had undergone a RYGB~     operation show a brain activity pattern that more closely mimics that of lean than severely~     obese women. In a supplementary test the investigators will assess gastrointestinal and~     metabolic response to a standardized meal in order to elucidate putative correlation of these~     responses with the results of fMRI scannings.~   "
158334|NCT01493570|"~     Due to the exploratory nature of this trial, there is no primary objective in a confirmatory~     sense. The study aims~      - to evaluate the effect of different doses of BI 409306 on biomarker and to assess the~     exposure of BI 409306~   "
158335|NCT01493557|"~     This is a prospective and open label study that aims to enroll approximately 1200 patients~     with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of~     gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125~     sites in North America will be recruited. Patients who report GIS during the 3 month~     treatment period will be randomized to one of two management strategies, and data documenting~     the intensity and duration of the GIS will be collected.~   "
158336|NCT01493544|"~     PUMA is an observational, multicentre, multinational, cross-sectional study with primary care~     physicians (primary care, general and family physicians). Participants will be selected~     sequentially among patients at risk for Chronic Obstructive Pulmonary Disease (COPD) who~     attend primary care consultation (primary care, general and family physicians). The inclusion~     visit will be a regularly scheduled or spontaneous consultation for patients, and this~     appointment with the physician will not depend on the study. During the appointment, data~     will be collected from the patient and the physician.~   "
158339|NCT01493505|"~     The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination~     with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.~   "
158340|NCT01493492|"~     As a noninvasive examination, urinary proteomics is a very useful tool to identify renal~     disease. The purpose of the present study was to find differential proteins among patient~     with SIRS and sepsis(included survivors and non-survivors), and to screen potential~     biomarkers for the early diagnosis of sepsis and its prognosis. Urinary proteins were~     identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was performed with the~     Mascot software and the International Protein Index (IPI) and the Gene Ontology (GO) Database~     and KEGG pathway Database. The differentially expressed proteins were verified by Western~     blot by another sample collected from clinical.~   "
158341|NCT01493479|"~     90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in~     patients who have received previous treatment for lymphoma. More than two-thirds of the~     patients who achieve CR go on to experience durable remissions lasting for years. Despite~     these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular~     lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The~     objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in~     patients with previously untreated follicular lymphoma in a Phase II study.~   "
158342|NCT01493466|"~     Serum proteomics is a very useful tool to identify various disease. The purpose of the~     present study was to find differential proteins among patient with normal, SIRS, sepsis,~     severe sepsis, death and to screen potential biomarkers for their dynamic changes. Serum~     proteins were identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was~     performed with the Mascot software and the International Protein Index (IPI) and the Gene~     Ontology (GO) Database and KEGG pathway Database. The differentially expressed proteins were~     verified by Western blot by another sample collected from clinical.~   "
158343|NCT01493453|"~     In particular circumstances T cells can be an effective treatment for malignant disease, for~     example, donor lymphocyte infusions following allogeneic transplants or treatment of EBV~     related lymphomas post allograft. However, many common cancers are poorly recognised by the~     immune system in part because of a lack of suitable T cell targets and in part because of~     defects in antigen presentation by tumours (Garrido, et al 1997). Genetically modified T~     cells engineered to express chimeric immune receptors (CIRs) on their cell surface can bypass~     the need for MHC presentation and thus represent an attractive approach to immunotherapy~     (Gross, et al 1989).~   "
158344|NCT01493440|"~     Atosiban, administered at embryo transfer, can improve the implantation rate and the clinical~     pregnancy rate in patients with repeated implantation failure undergoing IVF-ET (in-vitro~     fertilization and embryo transfer).~   "
158345|NCT01493427|"~     The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution~     without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or~     bimatoprost 0.01% ophthalmic solution monotherapy.~   "
158346|NCT01493414|"~     The primary objective of this study is collect additional safety of INC424 in patients with~     Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia~     Myelofibrosis, who have either received prior treatment with commercially available agents or~     who have never received treatment.~   "
158347|NCT01493401|"~     Female urinary incontinence (UI) can be caused by pure stress UI (SUI), pure urgency UI (UUI)~     and mixed SUI and UUI (MUI). Clinically it might not be that easy to separate MUI and SUI.~     Patients might perceive urgency when they have an incompetent urethra and a full bladder.~      Urinary tract nerve growth factor (NGF)is produced by bladder urothelium and smooth muscle.~     Increased levels of NGF have been reported in the bladder tissue and urine of patients with~     overactive bladder (OAB).~      If the urinary levels of NGF differ among women with pure SUI and MUI, then urinary NGF level~     might be a biomarker in the differential diagnosis of MUI in women.~      Also, decreased urinary NGF level was reported in OAB patients of whom the symptoms were~     improved. So, we might expect that the remnant OAB symptom including urgency incontinence can~     be improved, if the urinary NGF levels decrease after midurethral slings for SUI in MUI~     patients.~      We aimed to explore the value of the urinary NGF as a biomarker for differential diagnosis~     and as a prognostic marker for predicting the improvement of OAB symptom after midurethral~     slings.~   "
158348|NCT01493388|"~     This study is conducted in Africa. The aim of this study is to estimate the percentage of~     children and adolescents below or equal to 15 years in Tunisia with acceptably controlled~     diabetes mellitus type 1.~   "
158349|NCT01493375|"~     In Denmark, approximately 13,000 operations are carried out every year. Prosthetic infection~     is a very serious condition and despite extensive prophylactic measures, prosthetic~     infections appear in 1-2 percent of the operated patients.~      It is difficult to diagnose prosthetic infection with the techniques applied so far and~     incorrect diagnosis might imply unnecessary reoperations as well as unnoticed infections~     might lead to prolonged pain and invalidity.~      The purpose of this study is to examine the value of these three techniques applied as a~     supplement to the existing technology and on this basis to prepare an algorithm for the~     examination of joint prosthesis infection.~   "
158350|NCT01493362|"~     This study will use positron emission tomography imaging to investigate the dopamine systems~     in people with bulimia nervosa.~   "
158351|NCT01493349|"~     Colonic diverticular disease is a highly prevalent condition in Western populations. The~     prevalence increases age-dependently from 5% at 40 years to 65% by the age of 85 years (1-3).~     The majority remain asymptomatic. However, a significant proportion of the patient population~     develops complications, such as diverticulitis with or without symptoms (10-20%) (1, 4-10).~     Perforated diverticulitis is rare with an estimated incidence of 4 per 100.000 per year, but~     the associated mortality rate is 22% to 39% (9, 11, 12). In the United States, the~     complications related to diverticular disease account for 130.000 hospitalizations each year,~     resulting in substantial health care costs (13). In Europe, it is estimated that~     approximately 23.600 deaths per year can be attributed to complicated diverticular disease,~     and the mortality will probably increase in the future due to the aging population (15-17).~     Several case studies report an overall increase in the incidence of diverticulitis, based on~     the increase in hospitalizations (18). Kang et al, reported a 16% increased male admission~     rate and 12% female admission rate for diverticulitis, between 1989/1990 and 1999/2000 (19).~     Aging and the Western diet, low in fiber and high in fat, in combination with increased~     intraluminal pressure and alterations in colonic motility are considered important~     etiological factors. A disturbance in large bowel motility is suggested to be a common~     pathophysiological feature in IBS and diverticular disease (20, 21). Based on observations~     that IBD, subgroups of IBS and (symptomatic) diverticular disease share clinical symptoms,~     the hypothesis is derived that they might also share pathophysiological factors like low~     grade inflammation, changed microbiota composition and activity, and increased intestinal~     permeability. The identification of clinical and pathophysiological factors associated with~     an increased risk for complicated diverticular disease may help to identify patients with~     diverticular disease, prevent complications, develop strategies to improve quality of life~     and reduce the related health care costs. Therefore we aim to investigate the composition of~     luminal and mucosal intestinal microbiota and the intestinal permeability in the development~     of diverticular disease and complicated diverticular disease. We hypothesize that both the~     intestinal microbiota and intestinal permeability are altered in patients with (current- or~     previous history of complicated) diverticular disease.~   "
158352|NCT01493336|"~     This randomized, open-label, two-way crossover study will evaluate the relative~     bioavailabilty and safety of capecitabine rapid disintegrating tablets (RDT) versus~     commercial Xeloda tablets in patients with colorectal or breast cancer. Patients will be~     randomized to a sequence of single oral doses of capecitabine RDT or Xeloda on Days 1 and 2~     of a 14-day treatment cycle with Xeloda. Follow-up will be 30 days.~   "
158353|NCT01493323|"~     Suicidal behaviour (SB) represents a major public health problem, costing life in more that~     one million people every year worldwide. Even if SB is considered as a consequence of social~     adversity and depression, these stress factors are often necessary but not sufficient to~     explain the occurrence of a suicidal act. A preliminary study suggests that an increased~     perception of psychic pain during a major depressive disorder increases the risk of suicide~     behaviour. The investigators aimed to investigate the relationship between social exclusion~     (a classic trigger of psychic pain) and SB and improve our knowledge about the~     physiopathology of this domain.~   "
158354|NCT01493310|"~     This trial will find the best dose of mifepristone when given together with nab-paclitaxel~     (Abraxane) based on the side effects of the two drugs in patients with advanced breast~     cancer.~      Patients will be randomized to receive nab-paclitaxel with or without mifepristone during the~     first treatment cycle. After the first cycle, all patients will receive nab-paclitaxel with~     mifepristone until their disease worsens or they experience an unacceptable side effect.~      This study will test up to 4 doses of mifepristone in combination with nab-paclitaxel. The~     study will first test the lowest dose in a small group of patients and if they do not have~     bad side effects, higher doses will be tested.~   "
158355|NCT01493297|"~     The objective of this study is to investigate the effect of vitamin A and carotenoids on iron~     absorption in healthy subjects with low and normal vitamin A status. Vitamin A and~     carotenoids have been reported to enhance the nonheme iron absorption, but the results from~     human isotope studies are equivocal. Radio-iron studies in Venezuelan adults have~     consistently reported an increase in iron absorption, whereas stable and radio isotopes~     studies conducted in Sweden and Switzerland reported no influence. Differences in vitamin A~     status of the subjects may be a possible explanation for the contradictory findings. In this~     study, iron absorption will be measured from an iron-fortified maize bread meal with or~     without retinyl palmitate or β-carotene by using both stable- and radioactive-isotope~     techniques in Venezuelan women with a range of vitamin A status.~   "
158356|NCT01493284|"~     The purpose of this study is to assess the safety and effectiveness of the SJM Portico~     Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in~     subjects with severe symptomatic aortic stenosis (AS).~   "
158357|NCT01493271|"~     This randomized, double-blind, placebo-controlled, multi-center study will evaluate the~     safety and the effect of RO5093151 on intraocular pressure in patients with ocular~     hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of~     RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the~     possibility to extend to 28 days.~   "
158358|NCT01493258|"~     In this project the investigators seek to utilize our experience for developing a~     comprehensive informatics framework for rapid adaptation and dissemination of Comparative~     Effectiveness Research (CER) products tailored to different categories of health consumers~     including difficult-to-reach patients. Based on our previous successful experience in~     computer-assisted education, the investigators will refine the current CO-ED platform to~     implement and test a novel system for individualized continuous patient education (iCOPE).~     The iCOPE platform will be specifically designed to support rapid adaptation, customization,~     and dissemination of the CER products to the difficult-to-reach populations. The iCOPE~     platform will implement universal means for customized delivery of CER information in the~     format of interactive self-paced educational modules, quick question & answer guides, and~     interactive decision aids. In addition, the iCOPE platform will support the innovative~     concept of continuous patient health education by providing patients with easy access to the~     interactive CER updates via web, MP3 players and phone-based interactive voice response (IVR)~     technology. Though iCOPE will be designed to support the whole spectrum of CER products, in~     this project the investigators will focus on the Comparative Effectiveness Research Summary~     Guide (CERSG) entitled Pills for Type 2 Diabetes.~      The following primary hypothesis will be tested in the RCT: Use of the iCOPE platform will be~     associated with improvement in CERSG knowledge in elderly at 6 months after the intervention.~      The investigators will also examine the impact of iCOPE on medication adherence~     self-efficacy, diabetes medication satisfaction, HbA1c, and CERSG acceptance.~   "
158359|NCT01493245|"~     The purpose of this study is to evaluate the efficacy and safety of JNS020QD in patients with~     moderate to severe chronic pain who switched from opioid analgesics, as well as the safety~     and efficacy of long-term treatment (52 weeks) after switching to JNS020QD.~   "
158360|NCT01493232|"~     In this randomized clinical trial to compare the patients' satisfaction of complete dentures~     with different occlusal forms, after simple randomized sampling of 15 participant that will~     be signed informed consent and their latest teeth was extracted 3 month ago, will be~     selected. For each participant, it will be made 3 set of complete dentures that are variable~     in occlusion only. During the study, dissatisfied participants can leave it. Each set will be~     inserted for 1month in 5 participant randomly. The participants will be examined in two~     stages, after a day and after a week. At the end of month the questionaire will be filled out~     and the pressure under the mandibular denture base will be measured with the pressure~     sensors. Then the second and third denture will be inserted simultaneously.~   "
158361|NCT01493219|"~     The purpose of this study is:~        1. To learn if (MMP-2, MMP-9 and NGAL) which are substances found in blood and urine~          associated with tumors, can be used as tumor markers in the management and treatment of~          glioblastoma.~        2. To study the relationship between MMP-2, MMP-9 and NGAL with quality of life and disease~          symptoms.~   "
158362|NCT01493206|"~     The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal~     cancer improve outcomes without causing significant side effects.~   "
158373|NCT01493063|"~     The aim of the study is to estimate the impact of the protein content of breastmilk at the~     end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old.~      The investigators expect a difference of at least 5 points of Development Quotient (DQ) when~     comparing extreme terciles of the protein content of breastmilk at the end of~     hospitalization.~   "
158363|NCT01493193|"~     It is the aim of the study to compare the effects of 6 weeks of either high-intensity~     interval training (HIT; carried out at correctly assessed 85-95% of maximal heart rate),~     pyramid, or continuous endurance training, on changes of physical exercise capacity in~     cardiac patients.~      The three exercise arms (isocaloric) are composed as follows:~      Endurance training (n=15): 31min at 65-75% HRmax; HIT (n=15): 4x4min intervals at 85-95%~     HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min;~     Pyramids (n=15): One Pyramid consists of 8 one-minute blocks. Those are grouped starting with~     one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85%~     HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards~     with one block at 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75%~     HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax,~     making it a total of 28min.~      All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70%~     HRpeak.~      Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of~     power output in watt at lactate thresholds at 2 and 4 mmol/l.~   "
158364|NCT01493180|"~     The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for~     patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also,~     safety of OPC-12759 is to be assessed.~   "
158365|NCT01493167|"~     The purpose of study is to verify that WOODCAST Circular system performs safely and~     effectively in its intended use.~   "
158366|NCT01493154|"~     This study will test the safety of an HPV DNA vaccine after it is injected into your muscle~     using an electroporation device (TriGridTM Delivery System made by Ichor Medical Systems),~     and will test the ability of the vaccine to help your body's immune system to recognize~     HPV-infected and associated cancer cells. In addition to giving the vaccine using an~     electroporation device, we are giving the vaccine in combination with an immunomodulatory~     agent to further enhance immune responses against HPV-infected and associated cancer cells.~   "
158367|NCT01493141|"~     In recent years hip resurfacing has become a very popular alternative treatment to total hip~     replacement for the treatment of hip arthritis. This procedure has become particularly common~     in the young patient with arthritis because of perceived benefits in terms of functional~     outcome. However, it has recently become apparent that hip resurfacing is associated with a~     range of adverse events, not typically seen in patients with conventional hip replacement.~     These include hip fracture, and failure of bone to grow onto the fixation surfaces of the~     implant. It has also become apparent that hip resurfacing results in the release of high~     concentrations of dissolved metals in the bloodstream, such as cobalt and chromium. Whilst~     small concentrations of these metals are essential for normal body functions, such as making~     red blood cells, in high concentrations their effects can be toxic to many cells and organs~     of the body, such as bone, the brain, heart, liver and kidneys, as well as disturbing~     hormones and blood cholesterol levels. Whilst several studies have documented levels of these~     metal ions of 440 times normal levels in hip resurfacing patients, there are no studies that~     have examined whether these levels are having a toxic effect on the various organ systems of~     the body (with the exception of renal function). In this study we plan to explore whether~     there are differences in bone mineral density, accumulation of metal ions in the brain, and~     other solid organs, heart and hormonal function between subjects who have had a hip~     resurfacing 5 or more years previously compared to an individually matched group of subjects~     after conventional hip replacement.~   "
158368|NCT01493128|"~     The aim of this work is to study the prevalence of T-tubular system in left and right~     myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and~     permanent atrial fibrillation. Furthermore, since current information is lacking on the key~     Ca2+-handling proteins RyR, NCX, and SERCA-2a from patients in Atrial Fibrillation (AF), it~     will be investigated whether a regulation of these proteins could be an underlying cause of~     the disease. Mitochondrial function will also studied.~        1. The investigators hypothesize that both structure of sarcolemma and localization of key~          Ca2+-handling proteins are altered in patients with atrial fibrillation compared with~          patients in sinus rhythm.~        2. The investigators hypothesize that mitochondrial function is altered in patients with~          atrial fibrillation compared with patients in sinus rhythm.~   "
158369|NCT01493115|"~     Primary Objective:~      To compare the pharmacodynamic properties of two different doses of a new insulin glargine~     formulation with 0.4 U/kg Lantus®~      Secondary Objective:~      To compare the pharmacokinetic properties of two different doses of a new insulin glargine~     formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin~     glargine formulation~   "
158370|NCT01493102|"~     The purpose of this study is to evaluate the incidence of hypotension based on the~     discontinuation order of norepinephrine and vasopressin in patients receiving concomitant~     norepinephrine and vasopressin infusions for the treatment of septic shock.~   "
158371|NCT01493089|"~     Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied~     by acid regurgitation and other symptoms, has a substantial negative impact on a patients'~     quality of life. Although a number of treatment options are available, a more effective~     therapy is still required. The failure of proton pump inhibitors (PPIs) to completely resolve~     symptoms is an accepted problem, with approximately 25% of patients with GERD continuing to~     experience the symptoms of heartburn in spite of treatment. This study aims to demonstrate an~     earlier onset to relief of symptoms in patients suffering from heartburn associated with GERD~     using an immediate-release omeprazole/sodium bicarbonate formulation when compared with~     delayed-release omeprazole (Losec®).~   "
158372|NCT01493076|"~     Precut-sphincterotomy is a well established alternative after repeated futile attempts for~     common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly~     used devices instruments for pre-cutting are the needle-knife and the Erlangen-type~     precut-sphincterotome. In 1996 a so called baby-sphincterotome (Easy-Cut®, MTW, Wesel,~     Germany) with a pre-shaped-bended (to facilitate biliary access) small-calibre 3-French tip~     was developed, which enables cannulation and pre-cutting in one step. Here the investigators~     report on the clinical evaluation of this device.~   "
158466|NCT01491854|"~     This study is performed as part of the Marketing Authorisation Holder's post-marketing~     pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic~     potential and immunogenicity of rhGH therapy in short children born small for gestational age~     (SGA).~   "
158374|NCT01493050|"~     The purpose of this study is to see if taking a medication can lower the amount of oxidants~     from food that go into our body. Previous research shows that if the investigators lower the~     oxidants from food in people with diabetes, this simple change lowers different risks for~     heart disease and the worsening of kidney disease. The investigators focus on a specific type~     of oxidant, advanced glycation endproducts (AGEs). A previous, smaller study, conducted by~     our group showed that a drug, already approved by the FDA, will lower AGEs in the~     investigators compared Renvela® to Tums®. Both of these drugs have few side effects and have~     been used for a long time in patients with diabetes and kidney disease. While our previous~     study was interesting, it was just too small to be able to be sure that it will help all~     people with diabetes, or if the good effects the investigators found were simply due to~     chance. The investigators are doing this new study to confirm or deny the possibility that~     Renvela® can really help people with diabetes and kidney disease.~   "
158375|NCT01493037|"~     A prospective multi-center study in which patients with an acute heart attack (in the left~     anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty~     followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept~     study designed to document the safety and feasibility of the Pressure Controlled Intermittent~     Coronary Sinus Occlusion (PICSO) Impulse system.~   "
158376|NCT01493024|"~     It is hypothesized that zirconium silicate is safe and well tolerated and more effective than~     placebo (alternative hypothesis) in lowering serum potassium levels in subjects with serum~     potassium between 5 - 6.0 mmol/l versus no difference between zirconium silicate and placebo~     (null hypothesis). It is hypothesized that zirconium silicate even up to the top dose of 10g~     three times a day is well tolerated.~   "
158377|NCT01493011|"~     Millions of patients die of non-small cell lung cancer (NSCLC) every year. There are several~     methods to treat NSCLC, including surgery, chemotherapy, radiotherapy and bioimmuotherapy.~     Recently, hyperthermia therapy has played an important role in neoplasm therapy. It has~     showed some effect in NSCLC both in animal experiment and clinical practice, yet there is~     little literature about Whole-body Hyperthermia (WBH) with neoplasm. The investigators~     decides to develop this randomized contrasted multicenter clinical study to testify to the~     effect of chemotherapy combined with WBH to treat stage IIIB/IV Non Small Cell Lung Cancer~     (NSCLC).~   "
158378|NCT01492998|"~     In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts~     nuclear receptor FXR by either agonists or antagonists respectively increases or decreases~     the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal~     sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already~     been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290:~     765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone~     given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected~     patients.~   "
158379|NCT01492985|"~     The combination of GTU-MultiHIV B DNA and LIPO-5 vaccines in a prime-boost strategy is~     expected to induce strong and diverse HIV-specific immune responses in HIV-infected patients.~     The investigators will carry out the clinical therapeutic immunization proof of concept~     trial in HIV infected patients. The investigators propose a multi-center double blind~     randomized versus placebo phase II clinical trial in patients who are chronic asymptomatic~     HIV-infected patients, with undetectable viral load while treated with a potent combination~     of antiviral drugs. Patients will continue antiviral therapy combined with either therapeutic~     vaccination or placebo vaccination. Patients will undergo the procedure which includes a~     prime with the GTU-MultiHIV B DNA vaccine or placebo administered by IM injections via~     Biojector (a needle-free injection system) followed by a boost of LIPO-5 vaccine or placebo~     also given IM.~      In total, 105 HIV-1 patients will be enrolled: 35 in the placebo arm and 70 in the vaccine~     arm. Patients will receive antiretroviral treatments and 3 administrations of DNA vaccine or~     its placebo at weeks 0, 4 and 12 (corresponding to prime vaccinations). They also receive 2~     doses of LIPO-5 vaccines or its placebo at week 20 and 24 (corresponding to boost~     vaccinations). At week 36 antiretroviral treatments will be interrupted until week 48.~     Patients will be intensely monitored during the treatment interruption period. After start of~     cART treatment (at the latest in W48), a data collection from clinical car will be carried~     out. A blood sample with W74 will allow to study the persistence ot the immunizing responses,~     1 year after the injection of the last vaccine/placebo.~      The primary efficacy endpoint is a plasma HIV-1 RNA level at week 48 (e.g. 12 weeks after~     stopping all antiviral treatment).~      The main hypothesis for conducting a phase II randomized trial is that immune responses in~     vaccinated patients may be associated with a better control of viral replication following~     c-ART interruption as compared to placebo-vaccinated patients.~   "
158380|NCT01492972|"~     The purpose of this study is to compare the effects, good and/or bad of two treatment methods~     on subjects and their cancer.~      Proton beam radiation therapy is one of the treatments for men with prostate cancer who have~     localized disease. The benefit of the combination with androgen suppression is not completely~     understood. This study will compare the use of hypofraction proton therapy (28 treatments)~     alone to proton therapy with androgen suppression therapy.~   "
158381|NCT01492959|"~     This study is conducted in Asia. The aim of this study is to review the efficacy and safety~     of insulin treatment with InnoLet® in daily clinical practice.~   "
158382|NCT01492946|"~     The aim of this retrospective observational study is to determine the impact of preoperative~     nutritional status on postoperative outcome. Elective surgical patients were screened with~     Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for body~     composition. Outcome parameters were collected by patient chart review.~   "
158383|NCT01492933|"~     Background:~      - Studies show that alcohol changes the amount of many brain chemicals. These changes may be~     related to continued drinking, craving for alcohol, and relapse. This study will use magnetic~     resonance imaging (MRI) to look at brain areas and brain chemistry during an infusion of~     alcohol. It will also study how changes in brain chemistry relate to participant reports of~     feeling drunk.~      Objectives:~      - To use magnetic resonance imaging to measure the effect of alcohol on brain chemistry~      Eligibility:~        -  Individuals between 21 and 45 years of age.~        -  Participants will be either light drinkers (1 to 14 standard alcoholic drinks per week)~          or heavy drinkers (20 to 40 standard alcoholic drinks per week). A standard drink is a~          12-ounce beer, a 4-ounce glass of wine, or a shot of liquor.~        -  Participants must be able to go without alcohol for at least 3 days in a row without~          severe withdrawal symptoms.~      Design:~        -  This study requires two or three outpatient visits to the NIH Clinical Center.~        -  Participants will have a physical exam and medical history. Blood and urine samples will~          be collected. Participants' alcohol drinking habits will also be assessed to determine~          whether they may have an alcohol use disorder.~        -  At the first study visit, participants will have an infusion of alcohol. Blood samples~          will be collected to measure blood alcohol levels.~        -  The MRI study visit will take place about 3 days after the first study visit.~          Participants will have an MRI scan of the brain, followed by an infusion of alcohol and~          another scan. Blood samples will be collected.~        -  Participants will complete questionnaires before and after each infusion to measure~          their response to alcohol.~        -  Heavy drinkers will come to the clinic for a third visit to discuss possible future~          treatment and any risky behavior associated with their high levels of alcohol use.~   "
158409|NCT01492595|"~     The proposed study aims to establish a pilot program through a prospective cohort study~     offering routine contact tracing, investigation and prophylaxis for LTBI, and treatment of TB~     disease to children <5 years living in the same household as adults diagnosed with~     smear/culture-positive pulmonary TB in Mbarara Regional Referral Hospital~   "
158384|NCT01492920|"~     This randomized phase III trial studies how well acetyl-L-carnitine hydrochloride works~     compared to a placebo in preventing peripheral neuropathy in patients with recurrent ovarian~     epithelial cancer, primary peritoneal cancer, or fallopian tube cancer undergoing~     chemotherapy. Acetyl-L-carnitine hydrochloride may prevent or lessen peripheral neuropathy~     caused by chemotherapy. It is not yet known whether acetyl-L-carnitine hydrochloride is more~     effective compared to a placebo in preventing peripheral neuropathy caused by chemotherapy.~   "
158385|NCT01492907|"~     Study Design:~      This is a single institution pilot study to recruit 4 patients with operable pancreatic~     cancer scheduled for a pancreatectomy and 4 age/sex matched normal controls. Both groups will~     receive a single oral dose of radiolabeled MelQx followed by serial blood draws over an 8~     hour period and urine collections over a 24 hour period. In addition, normal pancreatic~     tissue and normal small bowel tissue will be collected by Tissue Procurement from resected~     (waste) tissue at the time of pancreatectomy on the 4 pancreatic cancer patients.~   "
158386|NCT01492894|"~     The purpose of this study is to learn the best way to prolong kidney life in patients exposed~     to calcineurin inhibitors, who already have evidence of damage possibly caused by the~     calcineurin inhibitor on kidney biopsy.~   "
158387|NCT01492881|"~     The purpose of this research study is to determine how multiple myeloma responds when the~     study drug vorinostat is added to the standard treatment of bortezomib and pegylated~     liposomal doxorubicin (PLD). After participants complete the three drug combination and if~     their multiple myeloma has decreased, the investigators also want to learn what effects (both~     good and bad) when vorinostat and bortezomib are given to people with multiple myeloma over a~     longer period of time. This type of treatment is called 'Maintenance Therapy'.~   "
158388|NCT01492868|"~     The purpose of this study is to investigate the relationship between viral infections of the~     upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the~     risk of acute bacterial sinusitis over a one year period. The investigators will determine~     the incidence of acute bacterial sinusitis post viral upper respiratory infection and~     identify the viral antecedent infections and other risk factors which predispose to infection~     and ultimately design strategies to reduce the burden of disease and antimicrobial~     resistance.~   "
158389|NCT01492855|"~     The knee menisci are two semicircular fibrocartilaginous structures located between the~     articular cartilage surfaces of the femur and tibia in the medial and lateral joint~     compartments. The main functions of the menisci are shock absorption and load transmission in~     the knee, mainly through distribution of mechanical stress over a large area of the joint~     cartilage.~      The hypothesis is that primarily older age, meniscal lesion and high pain score at baseline~     are associated with poorer outcome.~   "
158390|NCT01492842|"~     The proposed study is a substudy of ATN 106 and a cross sectional study intended to be~     conducted at each of the AMTUs newly participating in ATN III. The intent is to enroll all~     youth with behaviorally-acquired HIV who have enrolled in ATN 106. The study involves a~     review of the subjects' medical chart and a collection of an oral rinse sample.~   "
158391|NCT01492829|"~     The investigators will develop, deliver and evaluate a solar powered tablet-based individual~     and group focused HIV/STI prevention intervention with internally displaced women in Leogane,~     Haiti. Internally displaced women will be trained as community health workers to deliver the~     HIV/STI prevention intervention to other internally displaced women.~   "
158392|NCT01492816|"~     The proposed study seeks to continue Connect to Protect® (C2P) community mobilization efforts~     that have developed coalitions that plan for and bring about structural changes for purposes~     of reducing HIV incidence and prevalence among youth in targeted communities at nine sites.~   "
158393|NCT01492803|"~     This is a randomized placebo-controlled trial to examine if once daily probiotic therapy will~     lower serum LPS levels and immune activation among HIV-infected youth.~   "
158394|NCT01492790|"~     The purpose of this study is to evaluate if cholecystectomy first (studied group) versus~     sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of~     hospital stay, morbidity/mortality and costs in the management of patients with a suspicion~     of gallstone migration.~   "
158395|NCT01492777|"~     The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE)~     due to a narrow therapeutic window leading to important medical and economical consequences.~     The risk of ADE is increased partly by drug interactions and recently identified genetic~     factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9)~     as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide~     reductase complex subunit 1 (VKORC1).~      The objective is to determine the impact of several genotypes on acenocoumarol treatment and~     on vulnerability to drug-drug interactions.~   "
158396|NCT01492764|"~     This study will test the hypothesis that many human heart rhythm disorders are caused by~     small localized sources, where brief ablation may successfully eliminate the heart rhythm~     disorder.~   "
158397|NCT01492751|"~     The purpose of this study is to evaluate the effectiveness of the three most established~     primary treatments for patients with clinically localized prostate cancer (radical~     prostatectomy, external-beam radiotherapy, and prostate brachytherapy) at short, mid and~     long-term follow-up. The primary aim is assessing Quality of Life impact of treatments' side~     effects. As secondary objectives biochemical disease-free survival, overall survival, and~     prostate cancer-specific survival will be also assessed.~   "
158398|NCT01492738|"~     This study endeavors to examine the relationship between acupuncture, anxiety, and~     performance on a test of working memory. In the study, all participants will complete the~     State-Trait Anxiety Inventory (STAI) survey to determine how anxious they are at the moment~     and how anxious they tend to be in general. Then ½ of subjects will receive acupuncture for~     20 minutes and ½ will rest quietly for 20 minutes. After this period, all subjects will again~     complete the STAI survey. Then all subjects will complete the Automated Operations Span Task~     (AOSPAN) which is a computerized test of working memory. Statistical analysis will be~     performed to determine if acupuncture had any effect on State-level anxiety and on~     performance on the AOSPAN.~   "
158410|NCT01492582|"~     This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer~     survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine~     initiation among young cancer survivors, and (2) determining the immune response to and~     safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.~   "
158399|NCT01492725|"~     Patients presenting to the emergency department with acute ischaemic stroke, who are eligible~     for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for~     dual target major vessel occlusion and mismatch to determine their eligibility for~     randomisation into the trial. If the patient gives informed consent they will be randomised~     50:50 using central computerised allocation to intra-arterial clot retrieval after IV tPA or~     IV tPA alone. The trial is prospective, randomised, open-label, blinded endpoint (PROBE)~     design.~   "
158400|NCT01492712|"~     Anaesthesia for surgical procedures can be provided using a continuous infusion of~     intravenous drug. The most commonly used drug for this technique is propofol. Infusion~     devices programmed with pharmacokinetic models can be used to infuse propofol to achieve a~     target blood concentration. These pharmacokinetic models predict the rate of distribution of~     propofol within the body and also the rate at which it is cleared. In practice, the~     anaesthetist enters patient details such as age, sex and weight as well as a target blood~     concentration of propofol. The infusion device then infuses propofol at the appropriate rate~     to achieve this concentration.~      White and colleagues recently published the Covariates Model for propofol. It is anticipated~     that this model will have reduced bias and inaccuracy compared to the models in current~     clinical use. The VaSCoM study has three objectives:~        1. Prospective validation of the Covariates Model~        2. Modelling of the effect site concentration of propofol~        3. Comparison of propofol concentration in venous and arterial blood samples~      To achieve the above objectives, patients over 18 years of age and undergoing elective~     non-cardiac surgery will be recruited to the study. Anaesthesia will be delivered using a~     target controlled infusion device programmed with the Covariates Model for propofol. The~     target blood concentrations will be set according to a pre-determined schedule and all~     measurements will be made prior to the start of surgery.~      Prospective validation of the Covariates Model will be done by comparing blood concentration~     of propofol predicted by the model to those actually measured. These results will then be~     compared to the predictions made using the models in current clinical practice.~      Modelling of the effect site means predicting the concentration of propofol in the brain for~     a given blood concentration. This will involve using depth of anaesthesia monitors (such as~     bispectral index) as surrogate markers of brain concentration and comparing this to the~     predicted and measured blood concentrations of propofol.~      Finally, important information on the distribution and clearance of propofol can be gained~     through the comparison of venous and arterial blood samples. In this study, simultaneous~     sampling of venous and arterial blood will facilitate this comparison.~   "
158401|NCT01492699|"~     This is a clinical study for adult subjects with Post Traumatic Stress Disorder.~   "
158402|NCT01492686|"~     The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via~     intravenous drip infusion once a day in the patients with ALS based on the changes in the~     revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in~     double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186~     to the ALS patients.~   "
158403|NCT01492673|"~     The purpose of this study is to find out what effects, good and/or bad treatment with a new~     combination of drugs, cyclophosphamide, topotecan, and bevacizumab has on the patient and~     their cancer.~      The medications, cyclophosphamide and topotecan, are standard drugs often used together for~     the treatment of cancer in children with either Ewing's sarcoma or neuroblastoma.~      Bevacizumab is an experimental drug called an antibody that targets a protein important in~     the growth of cancer cells called vascular endothelial growth factor (VEGF). VEGF is made by~     tumor and other surrounding cells to help make blood vessels needed for the growth and spread~     of cancer cells in the body. The way that bevacizumab works is to stop the cancer cells from~     making their own blood supply, causing the tumor to stop growing bigger or from spreading. In~     adult clinical trials, bevacizumab has shown promising anti-cancer activity in patients with~     cancer of the colon/rectum (colorectal) and breast. It has been approved by the Food and Drug~     Administration (FDA) for use in patients with colorectal cancer but not in cancers found in~     children. Bevacizumab has been tested in early clinical studies in children and has been~     shown to be safe.~      Other goals of this study will include research tests designed to test the following changes~     in the patient or their cancer: to see how the body handles and breaks down bevacizumab~     (pharmacokinetics), to look at changes in proteins in the blood that may affect the way the~     cancer responds to the combination (angiogenic profile, angiogenesis associated serum~     biomarkers), to look at changes in genes that may affect how the cancer responds to treatment~     with this combination of medications (metabolic signature), and to monitor the effects of~     changes in the way the body grows and develops before and after bevacizumab is given.~   "
158404|NCT01492660|"~     Patients scheduled for total knee replacements and suitable for sciatic nerve block will be~     randomized to one of 2 groups.~      Group 1 will have the nerve block performed using a standard Pajunk block needle under~     ultrasound guidance and with electrical nerve stimulation (ENS), and have catheter placement~     also guided by electrical nerve stimulation. Group 2 will have the block performed using a~     Sonoplex echogenic block needle and have an echogenic catheter sited, all under ultrasound~     (US) guidance. Group 2 will have needle location aided by ENS, but ENS will not be used for~     catheter location.~      An observer blinded to the needle type will assess the quality of needle visualisation on a~     recording of the US image taken during the procedure, along with adequacy of spread of local~     anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be~     block success rate, block performance time, complication rate, number of needle passes per~     block, and adequacy of spread of local anesthetic.~   "
158405|NCT01492647|"~     The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA~     after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese~     participants with acne.~   "
158406|NCT01492634|"~     Title of study: Optimizing Fluid Status~      Study code: HD-IIT-01-E~      Study design: Prospective open design in study centre at two locations~      Applied medical device: Body Composition Monitor (BCM) for determination of fluid overload~     and dry weight~      Aim of the study: To improve the fluid status in chronic HD patients (measured as OH~     (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to now,~     the BCM was occasionally applied in both locations of the study centre.~      Study hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry~     weight (post-weight plan)will have significant consequences, namely a decrease of the:~        -  time averaged fluid overload (TAFO),~        -  proportion of patients with severe overhydration OH > 2.5 L,or OH/ECW > 15 %)~        -  proportion of dehydrated patients (OH < -1.0 L, or OH < -7 %),~        -  mean overhydration,~        -  variance of overhydration,~        -  time outside the reference range (-1.0L < OH < 2.5L).~      Devices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM,~     Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ;~     Body Composition Monitor BCM ; Data management software / database system NephroLink~     Disposables used in this study: BVM blood lines and BCM electrodes~      Patients: 60 patients~   "
158407|NCT01492621|"~     Subjects with major depression will be evaluated and intensively characterized through~     questionnaires, computerized cognitive evaluation and laboratory investigations. Magnetic~     resonance imaging will be used to document baseline white matter structure. subjects will~     then receive desvenlafaxine which will be adjusted as clinically indicated. After 16 weeks~     the evaluations will be repeated.~   "
158408|NCT01492608|"~     The purpose of the study is to assess whether magnesium sulphate for women at risk of preterm~     birth can protect their children against cerebral palsy. The results from this randomised~     controlled trial will be added to the previous meta-analysis to obtain firm evidence for~     magnesium sulphate as a neuroprotector, and determine whether it should be used as standard~     therapy for women in preterm birth.~   "
182405|NCT01177280|"~     This study explored the prevalence of DDEs in a chronic pain population with cLBP and~     associated healthcare utilization and costs using a healthcare claims database.~   "
158414|NCT01492530|"~     The MAALES Project is a community collaborative intervention designed to prevent HIV~     infection and transmission among African American men who have sex with both men and women.~     The investigators are a collaboration of researchers, community service providers and~     activists who are committed to developing and testing effective HIV prevention interventions~     that employ holistic and culturally relevant approaches. This includes recognizing the impact~     of forces such as racism, homophobia, heterosexism, sexism, and gender expectations on~     individual behavior and relationship dynamics in African American communities.~   "
158415|NCT01492517|"~     Purpose: The purpose of this protocol is to compare the genetic and epigenetic effects~     between diesel exhaust and ozone exposure in healthy individuals and in mild/moderate~     asthmatics.~      Participants: The investigators will recruit up to 30 mild to moderate asthmatics and up to~     50 healthy adults to participate in this study.~      Procedures (methods): Subjects will be exposed to clean air, to 300 µg/m3 of diesel exhaust~     for 2 hours and to 0.3 ppm of ozone for 2 hours with intermittent exercise in a controlled~     environment chamber. Primary endpoints will include spirometry and lung cell changes~     post-exposure. Secondary endpoints will include analysis of blood clotting/coagulation~     factors, Holter monitoring of cardiac parameters, analysis of soluble factors present in~     plasma and bronchial lavage and analysis of intracellular factors present in lung tissue~     obtained from a brush biopsy.~   "
158416|NCT01492504|"~     The primary purpose of this study is to determine whether the hepatitis C virus continues to~     remain unable to be detected in subjects who were previously treated with Asunaprevir~     (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.~   "
158417|NCT01492491|"~     The purpose of this study is to evaluate the serum concentrations of antoxidant vitamines A,~     C, E, inflammatory cytokines and middle-large toxins in patients treated with online~     hemodiafiltration, standard HFR and SUPRA-HFR.~   "
158418|NCT01492478|"~     The aim of this study is to do an evaluation of the clinical profile of depression in HCV~     patients (newly diagnosed and treatment naïve), and in these same individuals, 24 weeks after~     the beginning of IFN+Ribavirin therapeutics (n=100). To characterize depression associated to~     HCV with and without interferon (IFN), the investigators will use clinical, behavioral,~     biochemical and genetic markers, and to distinguish their different symptomatologic~     dimensions.~      The control group will be composed by 100 individuals with Major Depression diagnosis, and~     not from the general population, because the investigators are not trying to study the~     incidence of depression in general population, but to characterize the clinical profile of~     patients with HCV (IFN+Ribavirin) compared to major depression.~      Thus, the investigators will total 300 evaluations in 200 individuals, 100 from each group,~     and considering that the clinical group will be evaluated before the therapeutics and~     re-evaluated 24 weeks after its beginning.~      Hypotheses~        1. Depression in individuals affected by HCV is associated to genetic vulnerability.~        2. Genetic vulnerability increases the risk of depression when IFN therapeutics is used.~        3. Depression associated to infection by HCV presents a symptomatological profile that is~          different from general depression, which is maintained with IFN therapeutics.~        4. A higher state of depression in the beginning of a treatment, if not treated, is a risk~          factor to abandoning therapeutics.~        5. When comparing genders, women present a more severe symptomatological profile than men.~   "
158419|NCT01492465|"~     The purpose of this study is to determine whether AMG 876 is safe and well tolerated in~     subjects with type 2 diabetes.~   "
158420|NCT01492452|"~     This is a randomized clinical trial. The population consisted of parents of children~     undergoing cardiac surgery from December 2010 to April 2011. We included parents aged over 18~     years, and the following were considered exclusion criteria: inability to understand and/or~     answer the questions for any reason, parents of children undergoing surgery for insertion of~     the pacemaker and defibrillator, surgical death and not take up the case. 22 parents in the~     intervention group were randomized and received standardized guidelines for nursing and 22~     parents participated in the control group received the guidelines and routine of the~     institution. Anxiety was assessed using the STAI State-Trait Inventory in the preoperative~     period and 48 hours after surgery the child.~   "
158421|NCT01492439|"~     The purpose of this study is to determine whether cognitive remediation as an adjunct to~     supported education, will result in improved cognitive functioning, symptoms, and performance~     in academic domains for persons with psychosis compared to supported education given alone.~   "
158422|NCT01492426|"~     The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and~     Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b~     patients~   "
158423|NCT01492413|"~     This study was designed to test the impact of a 12-week online behavioral modification~     program for weight loss, with or without a fortified beverage. Subjects are randomized to~     four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling~     (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12~     weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after~     12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3) after~     12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.~   "
158424|NCT01492400|"~     This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal~     implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular~     edema (DME).~   "
158425|NCT01492387|"~     The purpose of the study is to assess the efficacy of an individualized approach to duration~     of antibiotic therapy based on each subject's clinical response compared to a local standard~     approach in patients coming from the community and who are hospitalized because of a~     pneumonia.~   "
158426|NCT01492374|"~     The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027~     on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and~     computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly~     intravenous (IV) infusions of BMS-241027~   "
158427|NCT01492361|"~     AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic~     acid (EPA) being developed by Amarin Pharma Inc. for the treatment of hypertriglyceridemia.~     The purpose of this study is to evaluate whether this drug, combined with a statin therapy,~     will be superior to the statin therapy alone, when used as a prevention in reducing long-term~     cardiovascular events in high-risk patients with mixed dyslipidemia.~   "
158428|NCT01492348|"~     The overall objective of this study is to test the effectiveness of a systems-level approach~     to primary care recognition and management of PTSD and depression in the military health~     system. More specifically, the investigators will test the effectiveness of a telephone care~     management with preference-based stepped PTSD/depression care--STepped Enhancement of PTSD~     Services Using Primary Care (STEPS UP)--as compared to Optimized Usual Care (OUC).~      Primary Hypothesis 1: Active duty primary care patients with PTSD, depression, or both who~     are randomly assigned to STEPS UP will report significantly greater reductions in PTSD and~     depression symptom severity compared to participants assigned to OUC over 12-months of~     follow-up.~      Hypothesis 2: Active duty primary care patients with either PTSD, depression, or both who are~     randomly assigned to STEPS UP will report significantly greater improvements in somatic~     symptom severity, alcohol use, mental health functioning, and work functioning compared to~     participants assigned to OUC over 12-months of follow-up.~      Hypothesis 3: The STEPS UP program will be both more costly and more effective compared to~     OUC over the 12-months of follow-up, and will have a favorable cost-effectiveness ratio in~     terms of dollars per quality adjusted life years saved.~      Hypothesis 4: Active duty primary care patients participating in STEPS UP, their clinicians,~     care managers, and family members will report that STEPS UP is acceptable, effective,~     satisfying, and appropriate PTSD and depression care.~   "
158429|NCT01492335|"~     Most primary care physicians do not screen older patients for cognitive impairment.~     Identification of cognitive impairment may result in earlier referral for diagnostic work-up~     and earlier treatment and better patient outcomes. The purpose of this study is to determine~     whether physicians who receive the results of a cognitive screen use this information in~     treatment plans and whether this results in better cognitive outcomes for the older patients.~   "
158430|NCT01492322|"~     A polymorphism in the dopamine transporter (DAT) may determine how much dopamine is available~     at the synapse and this may affect the underlying reasons for relapse in smokers. This~     research will use Single-photon emission computed tomography SPECT and the DAT-specific~     ligand, TRODAT (Dopamine Transporter Density by [99mTc]), to examine the availability of DAT~     in smokers grouped by genotype in the sated (just having smoked) and withdrawal (4 hours~     without smoking) conditions.~   "
158431|NCT01492309|"~     The purpose of this study is to determine if repetitive transcranial magnetic stimulation~     (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women.~      TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more~     effectively with one another. Effective neuron communication is thought to lead to the~     lessening of depressive symptoms. In this study subjects require daily TMS treatment for~     approximately four weeks.~   "
158432|NCT01492296|"~     Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty~     stomach is required to ensure quality and safety. For this reason, endoscopy is~     conventionally performed after 8 or more hours of fasting, which is potentially related to~     discomfort to the patients. In recent studies, surgical cholecystectomy has been described to~     be safe after two hours of fasting on liquids. The aim of this study is to assess safety,~     quality and comfort of upper GI endoscopy after two hours of fasting.~   "
158433|NCT01492283|"~     The main objective of this study is to analyze the pathophysiological implications of~     glucagon and the incretin hormones in patients with liver disease (Non alcoholic fatty liver~     disease (NAFLD) or cirrhosis) with and without diabetes compared with healthy controls. The~     present study will contribute significantly to the understanding of the pathophysiology of~     liver disease and glucose metabolism. The final goal is that the results could pave the way~     for new treatment modalities for patients with liver disease.~   "
158434|NCT01492270|"~     The incidence of prostate cancer is rising however the number of deaths from prostate cancer~     is stable. Meaning the investigators are diagnosing many men with prostate cancer that will~     not impact on their life. The rise in incidence is mainly due to increased use of the blood~     test Prostate Specific Antigen (PSA), as a screening test.~      Currently men suspected of having prostate cancer, identified by a raised PSA undergo~     trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test~     unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as~     it is random and performed blind-the operator does not know where the cancer is. Thus many~     low-risk cancers that do not need treating are diagnosed and many high risk cancers are~     missed or incorrectly classified. So, men with a negative biopsy or those with low risk~     disease are usually advised to undergo another TRUS biopsy.~      An imaging test is needed that could help men and their doctors decide whether the biopsy is~     a true reflection of what is inside his prostate.~      The investigators will test the role of two imaging tests. The first, multi-parametric~     magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The~     second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the~     results of these tests with a detailed biopsy map-transperineal template prostate mapping~     biopsy (which is currently the best way to find out what is in the prostate but requires~     multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one~     or more TRUS biopsies and who have been advised to have further tests on as part of standard~     of care. They will be recruited from UCLH referral letters and clinics.~      The investigators aim is to see if either of these tests can confidently rule out the~     presence of clinically important disease.~   "
158435|NCT01492257|"~     Total joint arthroplasty (TJA) is an effective procedure for reducing pain and improving~     function in patients with disabling osteoarthritis (OA) of the hip or knee. However, as with~     all invasive procedures, TJA is associated with certain risks and substantial costs. Since~     the indications for TJA are heavily dependent on patients' quality of life and expectations.~     TJA utilization rates vary widely throughout the United States, as seen with other~     'preference-sensitive' procedures. Early evidence suggests shared decision making (SDM)~     strategies are effective in enhancing patient decision quality, or the degree to which~     treatment decisions reflect the preferences of fully informed patients, especially for~     preference-sensitive procedures like TJA. Despite these advantages, however, SDM has not been~     embraced or widely adopted in orthopaedics. To investigate this limited uptake, the~     investigators propose a series of evaluations of individual-level strategies. The~     investigators innovative and unique contribution is to approach patients, surgeons and~     healthcare purchasers as having symmetric and equally valid concerns about the benefits and~     cost associated with SDM. The investigators overall objective is to facilitate wider~     dissemination of SDM strategies in orthopaedic practices. The specific aims of the project~     are to assess, for SDM strategies, the impact on key patient, surgeon, and healthcare~     purchaser priorities; By achieving this aim our project will produce new interventions and~     incentives for disseminating SDM that are endorsed as feasible and acceptable by a coalition~     of patients, surgeons, and purchasers. The investigators plans for evaluation include a~     randomized controlled trial to evaluate the impact of SDM on outcomes of interest to~     patients, surgeons, and purchasers.~   "
158436|NCT01492244|"~     Blank has designed a medical diagnostic system in the form of an unvalidated online~     questionnaire and drawing tool used to describe and identify the location of knee pain,~     respectively. A component of the survey includes the patient inputting their diagnosis as the~     etiology of their knee pain. Dr. Ivo Dinov's team has used the data from 100,000 patient~     surveys to construct a probabilistic model to diagnose those who fill out the questionnaire~     and knee pain map but do not have a diagnosis. However, the validity of the online survey and~     the accuracy of the probabilistic model has not been confirmed in patients with known~     diagnoses. Therefore, the purpose of this study will be to recruit patients with knee pain at~     UCLA orthopedic clinics to complete the online survey which will then be applied to the~     probabilistic model to output possible diagnoses. The results will be compared to the actual~     diagnosis assigned to that patient in the clinic. If validated, the online survey may serve~     as a tool for diagnostic and research purposes.~   "
158437|NCT01492231|"~     The main purpose of the protocol is to collect and evaluate performance data after patients~     undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive~     Digestive Disease Center (CDDC).~   "
158438|NCT01492218|"~     This study is conducted in Asia. The aim of this study is to assess patient satisfaction~     after switching to biphasic human insulin 30 treatment using the NovoLet® insulin device as~     treatment for diabetes mellitus under normal clinical practice setting.~   "
158439|NCT01492205|"~     This study is conducted in Asia. The aim of this study is to evaluate the overall acceptance~     of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital~     environment.~   "
158440|NCT01492192|"~     The goal of this clinical research study is to look at 2 new methods of scanning and see~     whether they can help researchers predict which tumours will respond to drugs that attack~     tumour blood supply.~   "
158441|NCT01492179|"~     Local anesthetics (LA) are increasingly used for postoperative pain management.~     Speicifically, several studies have found benefit of LA injected intra-abdominally following~     abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to~     local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The~     aim of this study is to assess whether lidocaine administered intravenously has similar~     analgesic efficacy as the same dose administered intra-abdominally in patients undergoing~     abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled~     analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.~   "
158442|NCT01492166|"~     This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and~     convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic~     agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.~   "
158443|NCT01492153|"~     This study is conducted in Asia. The aim of this study is to investigate the safety and~     efficacy of NovoLet® human insulin delivery system in an outpatient setting.~   "
158444|NCT01492140|"~     The purpose of this study is to characterize the safety and performance in normal therapeutic~     use of the Artiste System in comparison to standard manual administration of dermal fillers.~     Subjects are recruited from the investigator's practice and randomized to receive treatment~     with the Artiste System on either the left or right nasolabial fold, the contralateral fold~     to be treated with standard manual injections. Treatments occur in a single session to~     achieve optimal cosmetic results (OCR) balanced on both sides. Investigators are encouraged~     to use a variety of types and brands of dermal fillers, recruiting subjects for the study as~     necessary. Safety and performance evaluations will be made through a combination of clinical~     observations, questionnaires for the subject and for the Treating Investigator, and~     spontaneous reports of adverse events. There are 6 required study visits: Screening, Day 1~     (Treatment Day), Day 3, Day 8, Day 15, and Day 29.~   "
158445|NCT01492127|"~     This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of~     hepatocellular carcinoma (HCC) by studying their variation following curative treatment of~     HCC. The hypothesis of the study is that plasma proteasome levels will decrease following~     curative treatment, and that proteasome levels could be used as a marker to detect early~     recurrence.~   "
158446|NCT01492114|"~     This research will investigate the hypothesis that resveratrol when given orally to healthy~     adult smokers induces a decrease in the inflammatory and oxidative mediators which~     characterize the low-grade systemic inflammatory state and the oxidants-antioxidants~     imbalance of tobacco users.~   "
158447|NCT01492101|"~     The study is designed as an open-label, randomized, parallel, two arm, multicenter,~     international Phase 3 study in patients with recurrent or metastatic breast cancer previously~     treated with cytotoxic chemotherapy regimens.~      The primary study objective is to compare overall survival of patients who receive NKTR-102~     given once every 21 days to patients who receive treatment of Physician's Choice selected~     from a list of seven single-agent intravenous therapies.~   "
158448|NCT01492088|"~     The purpose of this study is to assess the safety and pharmacokinetics, and determine the~     pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.~   "
158449|NCT01492075|"~     The investigators hypothesis is that patient controlled local anesthetics administered~     intraabdominally are more efficacious compared to continuous infusion in reducing~     postoperative pain and morphine consumption.~   "
158450|NCT01492062|"~     You are invited to participate in a research study for the development of an artificial~     pancreas. An artificial pancreas uses a program which takes information from a continuous~     blood glucose monitor and uses that information to tell an insulin infusion pump how much~     insulin to deliver. The primary purpose of this study is to gain experience with insulin~     delivery algorithms or programs program (algorithm) provides the best regulation of glucose~     levels so that there are no severe low blood glucose reactions and blood glucose levels are~     generally between 70 to 180 mg/dl.~   "
158451|NCT01492049|"~     The goal of this study is to test patient education program for decision making about~     colorectal cancer (CRC) screening in community health centers.~   "
158452|NCT01492036|"~     The goal of this clinical research study is to collect information about the long-term safety~     of gene transfer therapy. This study is also designed to create a database of medical~     information about patients who have received gene transfer therapy, in order for researchers~     to track and review the long-term safety and any effects (good or bad) of gene transfer~     therapy.~   "
158453|NCT01492023|"~     The purpose of this study is to determine whether neuropsychological rehabilitation focused~     on attention retraining and teaching compensatory strategies has positive effects on~     cognitive performance, quality of life (QoL)and perceived cognitive deficits in patients with~     MS. The hypothesis is that the neuropsychological intervention shows positive effects on~     cognitive performance, QoL and perceived cognitive deficits.~   "
158454|NCT01492010|"~     Muscle mass is normally maintained through the regulated balance between the processes of~     protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old~     muscle proteins). Proteins are composed of amino acids and we know that amino acids increase~     muscle protein synthesis. However, not all amino acids are the same. Essential amino acids~     are ones that must be consumed through food, while non-essential amino acids can be made by~     our body. Interestingly, the essential amino acids are all that are required to increase the~     rate of muscle protein synthesis. In addition, the essential amino acid leucine appears to be~     particularly important in regulating protein synthesis. However, how leucine is able to~     increase protein synthesis is not entirely understood. Previously, it has been shown that~     20-25 g of high-quality protein, such as that found in milk, appears to be the amount of~     protein that maximizes the rate of muscle protein synthesis after performing a bout of~     resistance exercise. Thus, we aim to measure the synthesis of new muscle proteins after~     ingesting the following:~        1. 25g whey protein~        2. 6.25g whey protein supplemented with leucine~        3. 6.25g whey protein supplemented with essential amino acids but no leucine~      Thus, we will measure muscle protein synthesis after consumption of the above beverages in a~     leg that has done no exercise ( ie. a rested leg) and in the other leg that has done~     resistance exercise. We hypothesize that 6.25g whey supplemented with leucine will stimulate~     muscle protein synthesis as effectively as 25g whey, but that 6.25g whey supplemented will~     all the essential amino acids except whey will be less effective at increasing muscle protein~     synthesis. Whey protein is a dairy based protein found in cow's milk, thus when you drink a~     glass of milk you are consuming some whey protein. However we are using an isolated form of~     whey protein, meaning it has been removed from milk. As mentioned previously, amino acids are~     'strung-together' to make protein. The 'essential' amino acids must be consumed through food~     because our body cannot make them, thus they are consumed when you eat protein rich foods~     like milk or chicken.~   "
158455|NCT01491997|"~     Stress has been linked to chronic health problems, particularly diseases involving~     inflammation-mediated tissue injury and organ failure. Accordingly, it is not surprising that~     mind/body interventions are advocated for treatment of chronic inflammatory diseases. One~     such candidate disease is ulcerative colitis (UC) because: (1) UC is a life-long, relapsing,~     disabling inflammatory disorder of the intestine that lacks a non-toxic, efficacious~     treatment; (2) the therapeutic goal is to improve quality of life by ameliorating disabling~     symptoms and preventing disease progression by preventing disease flare-up, (3) stress~     triggers UC flare-up by modifying intestinal function and inflammatory processes,~     highlighting the potential therapeutic benefit of reducing physiological stress responses.~     The purpose of this study is to see if either of two 8-week mind/body medicine courses has an~     effect in reducing stress and affecting the course and severity of UC. Both have been shown~     to benefit other aspects of health and well-being.~   "
158456|NCT01491984|"~     A laryngoscope is a medical instrument that is used to get a view of the voice box and the~     space in between the vocal cords. A laryngoscope is used to place a breathing tube into the~     trachea (windpipe or airway) to protect the patient's airway and provide a way to help a~     person breathe during surgery; this is called intubation.~   "
158457|NCT01491971|"~     Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients~     with Prostate Cancer.~   "
158458|NCT01491958|"~     Phase II trial evaluating the safety & efficacy of Atorvastatin for prophylaxis of Acute~     Graft Versus Host Disease (GVHD) in patients with hematological malignances undergoing human~     leukocyte antigen (HLA)-Matched Related Donor Hematopoietic Stem Cell Transplant (HSCT).~   "
158459|NCT01491945|"~     The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is~     safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.~   "
158460|NCT01491932|"~     This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients~     who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias~     (PD-LID).~   "
158461|NCT01491919|"~     The drug lisinopril is approved by the U.S. Food and Drug Administration for the treatment of~     high blood pressure, heart failure, and acute heart attacks in adult patients. In children~     over 6 years of age, lisinopril is approved for the treatment of high blood pressure.~     Lisinopril is in a group of medications called angiotensin-converting enzyme inhibitors~     (ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals that tighten~     the blood vessels so blood flows more smoothly and the heart can pump blood more efficiently.~      There is some information available about how children with high blood pressure absorb,~     distribute, metabolize, and eliminate lisinopril (this information about medication~     processing by the body is called pharmacokinetic data). However, there is no information~     about how children with high blood pressure who have received a kidney transplant process~     lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril~     may help kidney transplants work longer by reducing the activity of chemicals made by cells~     in kidney transplants that can lead to inflammation and injury. Such benefits have not been~     found with another group of blood pressure medications called calcium channel blockers, which~     are the most commonly used medication group to control high blood pressure in children after~     a kidney transplant. A clinical trial will be conducted in the future to compare which~     medication group helps kidney transplants in children last longer. To guide the selection of~     the best dose to test in future studies, investigators in this study will try to determine~     the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and~     adolescents (2-17 years of age) who have received a kidney transplant and have high blood~     pressure.~   "
158462|NCT01491906|"~     The purpose of this study is to test the effect of a mobile phone-assisted lifestyle~     intervention on weight loss at 6 months among overweight/obese Chinese adults, as compared to~     a control group.~   "
158463|NCT01491893|"~     Purpose of the Study:~      To determine the maximally tolerated dose (MTD) or the Phase II dose of PVSRIPO when~     delivered intracerebrally by convection-enhanced delivery (CED). To obtain correlative~     mechanistic evidence of PVSRIPO's effects on infected WHO Grade IV malignant glioma tumors~     and to estimate progression-free survival (PFS) and overall survival (OS) in recurrent WHO~     Grade IV malignant glioma patients. To obtain information about clinical response rates to~     intratumoral inoculation of PVSRIPO. To estimate the efficacy of PVSRIPO administered at the~     optimal dose.~   "
158464|NCT01491880|"~     This pilot study will examine the feasibility of two modes of service delivery (e.g., a~     minimal therapist contact, self-help program, and a more intensive therapist supported,~     telephone-based approach) in a rural, primarily Latino, population. These modes of delivery~     may ultimately improve access to evidence based treatments and mental health outcomes among~     underserved groups.~   "
158465|NCT01491867|"~     Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide more~     information on the drug-related IOP change than 24-hour IOP measurement with Goldmann~     applanation tonometry (GAT.~   "
158467|NCT01491841|"~     Part 1: This is a phase I trial of the combination of bendamustine, rituximab and pixantrone~     in patients with relapsed/refractory B cell non-Hodgkin lymphoma. A standard 3+3 design will~     be used to determine the maximum tolerated dose (MTD) of the combination. A static dose of~     bendamustine and rituximab will be used and the dose of pixantrone will be escalated in each~     cohort. Pixantrone will be dosed on a 21 day cycle at 55mg/m2, 85mg/m2, and 115mg/m2 in~     sequential cohorts dependent on acceptable toxicity profile at each dose level. MTD will be~     determined based on DLTs that occur during the first 2 cycles of the drug combination.~      After 2 cycles of study drug, all subjects achieving stable disease or better may continue on~     study for up to 6 cycles. However, adverse events occurring during cycles 3-6 will not be~     considered DLTs and will not contribute to the determination of the MTD.~      Part 2: After the MTD is determined an expansion study is planned. This will be a phase II,~     prospective, open label, single arm study of combination therapy with bendamustine,~     rituximab, and pixantrone at the defined MTD schedule based on the phase I portion of this~     study. Subjects enrolled in part 2 of the study must have an aggressive, relapsed or~     refractory B-cell NHL, to include follicular lymphoma (FL) grade 3, Diffuse Large B Cell~     Lymphoma (DLBCL), transformed NHL, mantle cell lymphoma (MCL), and other aggressive~     histologies. We anticipate the total sample size to be 36 patients accrued at a rate of 2~     patients per month. Restaging will be employed after cycle 2, and if the patient has stable~     disease or better they may continue on study for up to 6 cycles.~   "
158468|NCT01491828|"~     This study will validate whether an external vibratory stimulus applied to a subject's neck~     causes head, neck or jaw movement.~   "
158469|NCT01491815|"~     This is an international (Nordic) trial designed to compare the safety and efficacy of active~     conventional therapy (ACT) and three biologic treatments in subjects with early rheumatoid~     arthritis (RA). The global aim of this study is to assess and compare~        1. the proportion of subjects who achieve remission with ACT versus three different~          biologic therapies (Certolizumab-pegol, Abatacept or Tocilizumab)~        2. two alternative de-escalation strategies in patients who respond to first-line therapy.~   "
158470|NCT01491802|"~     Preliminary information from our laboratory indicated that even patients with milder chronic~     obstructive pulmonary disease (COPD) can have significant physiological derangements which~     become more pronounced during exercise, leading to intolerable dyspnea at lower levels of~     ventilation than in health. This study will explore pathophysiological mechanisms of dyspnea~     and activity limitation in GOLD stage II COPD and will determine if there is a sound~     physiological rationale for the use of dual long-acting beta2-agonist (LABA)/long-acting~     muscarinic antagonist (LAMA) therapy (GSK573719/ GW642444 Inhalation Powder) versus LAMA~     alone (GSK573719) as treatment for dyspnea and exercise intolerance in this subpopulation.~     Objectives of this study are to determine if: 1) neuromechanical uncoupling of the~     respiratory system contributes to exertional dyspnea in milder COPD, and 2) treatment with~     LABA/LAMA improves dyspnea and exercise endurance compared with LAMA by improving~     neuromechanical coupling. The investigators hypothesize that: 1) dyspnea is related to~     excessive dynamic lung hyperinflation, tidal volume restriction and increased ratio of~     central respiratory neural drive to tidal volume displacement, a measure of neuromechanical~     uncoupling of the respiratory system, and 2) LABA/LAMA will improve dyspnea and exercise~     endurance, which will be explained by partial reversal of the above mechanical abnormalities.~     The investigators will conduct a randomized, double-blind crossover study and compare the~     effects of once-daily LABA/LAMA over 4-weeks with LAMA on dyspnea, exercise endurance and~     ventilatory mechanics in GOLD stage II COPD.~   "
158471|NCT01491789|"~     The research is being done to look at the benefits of a recreational and therapeutic program~     for people with spinal cord injury using the VSail-Access sailing simulator.~   "
158472|NCT01491776|"~     The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to~     accurately test a throat swab specimen from a symptomatic patient for the presence or absence~     of Group A Streptococcus (Strep A) when compared to culture.~   "
158473|NCT01491763|"~     20-25% of patients over 15 years with acute lymphoblastic leukemia (ALL) have the~     Philadelphia chromosome or BCR-ABL rearrangement. Traditionally, intensive chemotherapy~     followed by hematopoietic stem cell transplantation (HSCT) have formed the basis allogeneic~     treatment of this disease, but the results have been poor (60-75% complete remissions-RC-and~     probability of long-term survival less than 20%). The effectiveness of imatinib for~     hematologic responses in patients with Ph + (observed in phase I and II) led to its use in~     phase III trials in combination with chemotherapy. They saw a chance of obtaining the RC~     above 90%, with acceptable toxicity, a molecular response rate (MR) of 40-50%, and prolonged~     follow-up studies, a probability of disease-free survival (DFS ) of 30-50%, significantly~     higher than historical controls with the same chemotherapy without imatinib. This led to the~     approval of imatinib by the rating agencies in the U.S., Europe and Japan as a treatment for~     Ph + in combination with chemotherapy.~      Of the studies that led to the approval of this indication for imatinib, and other incurred~     after, the following conclusions can be drawn:~      There is no specific pattern of combination of imatinib (at doses of 600 mg / day, po) and~     chemotherapy. However, when compared with concomitant alternating with the first achieved a~     higher rate of RM at the end of induction, although this did not influence DFS.~      In studies in elderly patients has achieved a high CR rate (almost 100% in all series), only~     imatinib and glucocorticoids, suggesting that an attenuated induction may be sufficient to~     achieve CR in young patients with minimal toxicity, which further compromises the~     administration of treatment and allow for an allogeneic HSCT with minimal toxic load~     possible.~      Although there is no consensus on the indication of allogeneic HSCT in first CR when given~     imatinib associated with intensive chemotherapy is an option that is done in most studies.~      The allogeneic HSCT is most effective when carried out in complete molecular response to or~     greater than when there is more residual disease. However, the impact of MRI to obtain early~     (after induction) on survival is not clear. So far-reaching goal is to make the TPH in~     complete molecular response situation or greater.~      The relapse of the disease at the molecular level is still short-term (less than 3 months) of~     hematological relapse. This implies the need for frequent monitoring of residual disease (ER)~     The frequency of relapse post HSCT is high (around 30%), raising the need for any post HSCT~     treatment, including imatinib included. Are currently ongoing clinical trials comparing the~     systematic administration of imatinib after administration TPH face is detected only when ER.~      The applicability of the administration of imatinib after HSCT is limited by toxicity related~     to the procedure of TPH, is making frequent dose reduction or discontinuation.~      Therefore, a reasonable approximation treatment of Ph + outside the context of a clinical~     trial is to get as many molecular responses before allogeneic HSCT in a position to make the~     same MRI complete or greater. After TPH, must be very close monitoring of the ER, and~     imatinib is administered as soon as you notice the loss of molecular response.~      In patients who can not make an allogeneic HSCT for lack of histocompatible donor or~     contraindications for its realization it is recommended imatinib and chemotherapy, although~     there are studies that have undergone an autologous HSCT, followed or not treatment~     maintenance with imatinib. The low toxicity of autologous HSCT and no effect of graft~     versus leukemia are strongly recommended the administration of maintenance therapy with~     imatinib combined with chemotherapy or not.~   "
158474|NCT01491750|"~     The purpose of this mixed methods pilot study is to produce preliminary data for a~     randomized, placebo-controlled trial testing a biobehavioral model of the effects of guided~     imagery on outcomes of total knee replacement surgery.~   "
158475|NCT01491737|"~     This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy~     and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in~     first-line participants with HER2-positive and hormone receptor-positive advanced breast~     cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in~     combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may~     also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the~     investigator's discretion in combination with the assigned treatment arm. The anticipated~     time on study treatment is until disease progression, unacceptable toxicity, withdrawal of~     consent, or death whichever occurs first.~   "
158476|NCT01491724|"~     The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation~     in Gastric Intestinal Metaplasia (GIM)~      Objective:~      The aim of this study is to evaluate the learning curve of pCLE images interpretation in GIM.~      Research design:~      Blinded review of pCLE images for the diagnosis of GIM~      Sample size:~      Five beginner endoscopists will be assigned in this study to read approximately 80 videoclips~      Data analysis:~      ROC curve is analyzed by SPSS version 16.~      Expected Benefit and Clinical Application Information on the learning curve for GIM~     interpretation from pCLE images in order to develop early gastric cancer detection~   "
158485|NCT01491607|"~     The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of~     BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this~     study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax.~      This study will be conducted in the United States (U.S.), in 200 healthy male and female~     volunteer subjects ages 18 to 65 years.~      The duration of study participation for each individual subject will be approximately 128~     days (4.25 months), including a screening period of approximately 28 days followed by 100~     days on study.~   "
158486|NCT01491594|"~     The purpose of this study is to study the effect of eltrombopag on chemotherapy induced~     thrombocytopenia. Thrombocytopenia is when there is a low number of platelets in the blood.~     Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.~   "
158477|NCT01491711|"~     Skin cancer is the most common cancer in Caucasians, and a basal cell carcinoma (BCC) being~     the most common skin cancer with around 44,000 new tumours per year, and its incidence is~     still rising. In the past it has been a disease of the elderly patient but as a consequence~     of recreational sun exposure and tanning beds, more young patients develop a skin cancer as~     well. There are different subtypes of BCC and most subtypes are treated by surgical excision.~     Nowadays, non-invasive techniques as photodynamic therapy (PDT) are common practice to treat~     superficial BCC (sBCC). Because of these techniques treatment by surgical excision can be~     avoided with the possibility of complications and scar formation. Both 5-aminolevulino acid~     (5-ALA) and the more lipophilic methyl aminolevulinate (MAL) can be used as a precursor of~     the photosensitiser. These agents generate an excess of protoporphyrin IX in metabolic active~     cells, which are illuminated by a specific light source leading to release of reactive oxygen~     radicals in tissue. The result is apoptosis and necrosis of tumour cells. At the moment, two~     treatment protocols are used in the Netherlands: the fractionated 5-ALA 20% (Fagron) protocol~     according to de Haas and the MAL (Metvix, Galderma) protocol. Because MAL was first marketed~     and registered as a treatment option for premalignant and superficial malignancies most~     hospitals in the Netherlands use this topical agent. However, there is no evidence which of~     the 2 agents is more (cost-)effective and/ or preferred by patients.~      Objective: to determine which treatment is the most effective treatment in terms of~     prevention of treatment failure, cost saving and patients preference when comparing~     fractionated 5-ALA 20% PDT versus MAL PDT in 2 treatment sessions.~   "
158478|NCT01491698|"~     This study is being done to learn more about how different surgery procedures bring back the~     eating pathway after removing the stomach in patients with stomach cancer. If the surgeon has~     decided that some, or all, of the patient's stomach must be removed the surgeon must create a~     new way to allow food to travel from the mouth to the intestines. Some patients develop~     problems because they are missing their stomach, such as lack of hunger, bloating, cramping,~     and heartburn.~      The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if~     a change in surgery can help reduce these symptoms.~      The most common method of creating a way for food is called a Roux-en-Y, in which one part~     of the intestine is connected with the end of the esophagus (the swallowing tube) in the~     abdomen, and another connection is made between the intestines lower down.~      The change in surgery involves creating a pouch from a part of the intestines to replace the~     stomach.~      This study will compare the effects, good and/or bad, of gastric pouch reconstruction with~     the usual reconstruction to see if the pouch makes you feel better overall.~      This type of surgery has been used by some surgeons for many years and is known to be safe,~     but it is not known if it reduces symptoms or improves nutrition compared with the usual~     surgery.~   "
158479|NCT01491685|"~     This is an observational study comparing microcirculation of pregnant to non-pregnant women.~     Microcirculation means blood flow to the extremely small blood vessels in one's body.~     During pregnancy the amount of blood in a woman's body increases. The body responds to this~     increase by pumping more blood through the heart and narrowing the size of blood vessels.~      There are many types of blood vessels that have different roles in the body. Larger blood~     vessels. Transport blood to and from body organs like the brain and liver. Small vessels~     (microcirculation)distributes blood to the organ tissues. The microcirculation can change~     blood flow and blood pressure. Microcirculation is involved in delivering oxygen and~     nutrients to your body, removing waste products, and regulating body temperature.~      The investigators current understanding of the microcirculation in pregnant women is limited.~     There is a device available that can measure microcirculation. It is known as Sidestream Dark~     Field (SDF) imaging. It is a special type of camera that captures pictures of the~     microcirculation. In this study the investigators will compare the microcirculation, as seen~     with SDF imaging, of pregnant women to non-pregnant women. By improving the investigators~     understanding of maternal microcirculation the investigators are adding to the knowledge of~     how the pregnant body works. The investigators hope to then translate this knowledge into~     further studies to improve maternal and fetal outcomes through prevention and treatment of~     maternal low blood pressure caused by spinal anesthesia.~   "
158480|NCT01491672|"~     This study will evaluate everolimus as second-line therapy in patients with metastatic renal~     cell carcinoma. Each patient will be enrolled and stratified in one of three cohorts based~     upon their first-line therapy: 1) prior cytokines, 2) prior sunitinib, or 3) prior anti-VEGF~     therapy other than sunitinib.~   "
158481|NCT01491659|"~     It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side~     effects related to the use of antibiotics~   "
158482|NCT01491646|"~     Pulmonary hypertension (PH) is a condition in which high blood pressure develops in the lungs~     and right side of the heart. People with PH suffer from shortness of breath, chest pain,~     heart failure, heart rhythm problems, and fainting. PH is diagnosed using a test called a~     cardiac catheterization where blood pressure is measured directly using a tube placed in the~     right side of the heart and lung arteries. Because a cardiac catheterization is invasive,~     researchers are investigating ways to diagnose PH using imaging tests that are not invasive.~     The study will evaluate whether or not a magnetic resonance image (MRI) of the heart, and~     blood tests can detect PH.~   "
158483|NCT01491633|"~     Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has~     been used in treatment for other types of cancer and information from other research studies~     suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially~     in individuals whose tumor has a mutation in the DDR2 gene.~      Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic~     targets are needed. Several studies have examined dasatinib in NSCLC; these report~     significant toxicities, but also responses in patients found to harbor mutations in DDR2 or~     BRAF.~      An open-label phase II trial with dasatinib was carried out to determine the response rates~     in patients with SqCC who had previously failed standard chemotherapy and to correlate~     responses with patient genotype.~   "
158484|NCT01491620|"~     This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the~     treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).~   "
158487|NCT01491581|"~     The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar,~     specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium~     on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium~     and iron status, and on their cognitive performances.~   "
158488|NCT01491568|"~     The purpose of this study is to evaluate the feasibility of using the investigational implant~     (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral~     lumbar spinal fusion at two adjacent treatment levels in patients with symptomatic~     degenerative disc disease.~   "
158489|NCT01491555|"~     Researchers at Children's Hospital Boston Neurology Department invite children to participate~     in a new research study. Researchers are looking for boys ages 2 - 30 with Duchenne Muscular~     Dystrophy (DMD) and healthy boys ages 2 - 30 (without any nerve or muscle concerns) to serve~     as controls. The study is evaluating a new technique that will test nerve and muscle~     function. The testing is all pain free.~      Children participating in the study will come in for 10 visits over two years. Visits will~     take place every month at first, then less often for the remaining visits. The tests for the~     study itself take approximately 2hours. If participants are interested or would like to learn~     more about the study, please call Lavanya Madabusi at 617-919-3554 or~     Lavanya.Madabusi@childrens.harvard.edu. All inquiries will be kept strictly confidential.~   "
158490|NCT01491542|"~     The purpose of this pilot clinical trial is to evaluate the feasibility of using the~     investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON®~     Spinal System) as a method of facilitating spinal fusion in patients with symptomatic~     degenerative disc disease.~   "
158491|NCT01491529|"~     This study will assess the efficacy and safety of modified release AFQ056 in patients that~     have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)~   "
158492|NCT01491516|"~     The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™~     Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System) as a~     method of facilitating lumbar spinal fusion utilizing a posterior surgical approach in~     patients with symptomatic degenerative disc disease. The safety and effectiveness of the~     implant will be evaluated.~   "
158493|NCT01491503|"~     The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium~     and levocetirizine dihydrochloride in healthy male volunteers.~   "
158494|NCT01491490|"~     Olanzapine is one of the most effective and best tolerated of the atypical antipsychotics,~     but it is also particularly associated with weight gain and metabolic problems.~      This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the~     efficacy and safety of two medications GW42003 and GW42004 as a 40:1 ratio when combined with~     the subjects existing treatment of olanzapine in subjects with weight gain attributable to~     olanzapine treatment for functional psychosis. This is the first study to determine whether~     the study medications have a positive benefit for subjects on their cholesterol levels, body~     weight and other metabolic parameters, as well as a potential augmentation of the~     anti-psychotic effect of olanzapine.~      This is a multi-centre randomised, double-blind, placebo-controlled, parallel-group pilot~     study. There will be two groups of subjects (GWP42003 plus GWP42004 (40:1 ratio) and~     placebo), with a treatment duration of 6 weeks as well as a baseline period of variable~     length and one week follow-up. The two treatment groups will be randomised equally.~      In order to be eligible for enrollment in this study, subjects will need to be aged 18 years~     and above and be clinically diagnosed with functional psychosis and receiving olanzapine~     treatment for no more than 3 months with evidence of weight gain attributable to olanzapine~     treatment.~      Eligible subjects will enter the study at a screening visit (Visit 1) and commence a baseline~     period. Subjects will also be assessed at Visit 2 for further weight gain during the baseline~     period. The baseline period is flexible in length to allow time for this weight gain to be~     achieved and also for the olanzapine dose to be stabilised. If eligible the subject will be~     randomised into the 6-week treatment phase. There are a total of 6 visits in the study.~   "
158495|NCT01491477|"~     The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™~     Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal~     fusion in patients with cervical symptomatic degenerative disc disease.~   "
158496|NCT01491464|"~     The purpose of this clinical trial is to assess the safety and effectiveness of the~     rhBMP-2/ACS/INTER FIX™ device as compared to the autograft/INTER FIX™ device in patients with~     symptomatic degenerative disease.~   "
158497|NCT01491451|"~     The purpose of this pilot clinical trial is to evaluate the device design as a method of~     facilitating spinal fusion.~   "
158498|NCT01491438|"~     OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors~     (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the~     safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN:~     Randomized, open clinical trial in parallel groups, controlled with conventional treatment.~      SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous~     ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental~     group: Autologous PRGF administrated once a week (day 1) + conventional treatment~     administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where~     there has been no complete healing in this period, patients will continue the same management~     protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12~     weeks of treatment.~      Conventional treatment includes: Cleaning and debridement of the wound, the application of~     corresponding dressing, and using of antibiotic if necessary in each visit.~      STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude~     model and the adjusted model (for confounding variables)will be built. The healing time of~     ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding~     comparison using the log rank test.~   "
158499|NCT01491425|"~     This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE®~     Device using laparoscopic surgical technique as compared to an historical control group~     treated with Autogenous Bone/LT-CAGE® Device using an open surgical technique in patients~     with symptomatic degenerative disc disease.~   "
158528|NCT01491048|"~     This study aims to objectively evaluate the implications of physiotherapeutic rehabilitation~     in the Assistance Protocol of Total Hip Arthroplasty (THA), by assessing the motor~     performance and testing the quality of life of patients undergoing THA surgery, to improve~     rehabilitation strategies for this population.~   "
158529|NCT01491035|"~     The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its~     metabolites in connection with multiple oral dosing in child and adolescent patients with a~     DSM-IV-TR diagnosis of Depressive or Anxiety Disorder~   "
158500|NCT01491412|"~     This is an observational study describing the real-life antipsychotic treatment during the~     hospitalisation of the patients due to acute psychotic episode.~      In this NIS subject's data will be collected at one visit at the moment of discharge from the~     hospital.~      The results of the study would help to characterise the discrepancy between current clinical~     practice and treatment guidelines, indicating that atypical antipsychotics are preferable and~     should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia.~     Available evidence have revealed a frequent use of first-generation antipsychotics,~     polypharmacy, intramuscular route of administration and use of atypical antipsychotics in~     doses lower than recommended in registered summary of product characteristics.~   "
158501|NCT01491399|"~     The purpose of this clinical trial is to assess the safety and effectiveness of the~     Investigational implant as compared to the Control implant in the treatment of patients with~     one level or two adjacent levels of cervical symptomatic degenerative disc disease.~   "
158502|NCT01491386|"~     This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE®~     device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic~     degenerative disc disease using an open surgical technique.~   "
158503|NCT01491373|"~     This study is designed to evaluate the feasibility of recombinant human bone morphogenetic~     protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® )~     for anterior lumbar interbody fusion in patients with degenerative disc disease.~   "
158504|NCT01491360|"~     A new minimally invasive procedure for treating presbyopia is being evaluated to determine if~     there is improvement in near and intermediate vision after treatment.~   "
158505|NCT01491347|"~     Alcohol dependence is accompanied by several neurological mechanisms involving neuronal~     plasticity and neoneurogenesis, requiring Brain Derived Neurotrophic factor (BDNF) synthesis.~      The investigators found that serum BDNF levels in alcohol-dependent subjects increased to a~     greater extent in subjects who had remained abstinent at 6 months after withdrawal than in~     subjects who had relapse.~      To verify if the BDNF serum levels variation is linked to the way that abstinence is~     installed, wthe investigators will measure BDNF serum levels in alcohol dependent subjects at~     the moment of withdrawal, and 14, 28 days, and 2, 4, and 6 months after to establish its~     evolution in relation to alcohol consumption, and other clinical characteristics : depression~     intensity, anxiety, alcohol craving, biological markers of alcohol consumption or toxicity.~     Monitoring serum BDNF concentrations in link with other clinical data could help to~     characterize alcohol dependence profiles in clinical practice, help predict relapses, and~     assist in adjusting care to prevent difficulties in alcohol withdrawal.~   "
158506|NCT01491334|"~     The purpose of this study is to validate safety and effectiveness in assessment of the female~     pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early~     prolapse conditions and characterize the outcome of reconstructive surgery.~   "
158507|NCT01491321|"~     The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain~     intensity, functional status and quality of life of patients with chronic low back pain.~   "
158508|NCT01491308|"~     The rationale for perioperative red blood cell (RBC) transfusion is based on the observation~     that anemia is an independent risk factor for morbidity and mortality after cardiac~     operations. However, transfusions have been associated with high rates of morbidity and~     mortality in critically ill patients, and some recent studies have shown worse outcomes,~     including increased occurrence of renal failure and infection, as well as respiratory,~     cardiac, and neurological complications, in transfused compared with non transfused patients~     after cardiac surgery. On the basis of past clinical observations, some authors have~     suggested that hematocrit should be maintained at around 30% and hemoglobin concentration at~     10 g/dL. Recently, however, this hemoglobin threshold has been reconsidered because of~     recognized risks associated with transfusion and greater appreciation of the importance of~     individual physiological responses to anemia. In a comparative trial of 428 patients~     undergoing elective coronary artery bypass graft(CABG) surgery, Bracey et al reported that~     reducing the hemoglobin trigger to 8 g/dL did not adversely affect patient outcomes and~     resulted in lower costs. An important multicenter Canadian Study by Hebert et al that~     included a large number of critically ill patients revealed that A restrictive strategy of~     red-cell transfusion (hemoglobin concentration maintained between 7.0and 9.0g/dL) is at least~     as effective as and possibly superior to a liberal transfusion (hemoglobin concentration~     between 10 and 12 g/dL) strategy in critically ill patients, with the possible exception of~     patients with acute myocardial infarction and unstable angina, in terms of reducing organ~     dysfunction and mortality.~      The investigators would like to determine whether a restrictive strategy of red-cell~     transfusion and a liberal strategy produce equivalent results in orthopedic-oncology patients~     undergoing surgery.~   "
158509|NCT01491295|"~     1. Adefovir add-on therapy is superior to switching to adefovir monotherapy or entecavir~          1mg monotherapy for chronic hepatitis B (CHB) patients with lamivudine resistance~          (LAM-R)~        2. Long-term adefovir add-on therapy was effective for viral suppression. However, the~          economic burden for such dual antiviral therapy is heavy because of infinite treatment.~        3. Tenofovir disoproxil fumarate (TDF) is a potent antiviral agent. TDF demonstrated potent~          antiviral efficacy in a subset of lamivudine experienced HBeAg-positive patients. TDF is~          also superior to ADV in HBeAg-negative and HBeAg-positive treatment-naive patients.~        4. Theoretically, TDF can replace LAM/ADV when viral suppression has been achieved by~          LAM/ADV combination treatment in LAM-R CHB patients.~   "
158510|NCT01491282|"~     To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of~     human brown adipose tissue.~   "
158511|NCT01491269|"~     The aim of the present study was to investigate if guided Internet-delivered~     Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously~     undergone a multidisciplinary treatment but still have residual problems.~   "
158512|NCT01491256|"~     Pre-treatment with statins decreased the incidence of cardiac enzyme increase after~     percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI~     myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on~     post-procedural index of microcirculatory resistance (IMR) values that are introduced for~     assessing the status of the microcirculation.~   "
158513|NCT01491243|"~     Patients who undergo urgent/emergency coronary angiography can not receive any preventive~     treatment of contrast induced nephropathy. We tested the hypothesis that Neutrophil~     gelatinase-associated lipocalin (NGAL), a new biomarker predictive for AKI, allows early and~     effective treatment of contrast induced nephropathy in patients with urgent/emergency~     coronary angiography~   "
158545|NCT01490827|"~     This post-market surveillance study is conducted in the European Economic Area where Argus II~     has been CE certified for use in outer retinal degeneration patients.~   "
158514|NCT01491230|"~     Identifying the post-transplantation phase wherein neutrophils recover their ability to~     release NETs could shed new light on the mechanism responsible for the increased~     susceptibility to infection among these patients and aid in improving their prophylactic~     antimicrobial treatment. Therefore, we aim to examine neutrophil extracellular traps (NETs)~     formation, in relation to other neutrophil functions like chemotaxis, superoxide production,~     hydrogen peroxide production, and the presence of myeloperoxidase, in pediatric patients~     undergoing autologous and allogeneic hematopoietic stem cell transplantation (HSCT).~   "
158515|NCT01491217|"~     The main objectives of this study are to determine the maximum tolerated dose (MTD) and~     recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of~     Oraxol® in Phase II.~   "
158516|NCT01491204|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of Oral~     Paclitaxel. Eligible subjects of this study are patients with histologically or cytologically~     confirmed malignant solid tumor refractory to standard therapy.~      Administration Schedule: 1 cycle of Oraxol®(paclitaxel+HM30181A) medication was 28 days and~     Oraxol® was administrated total 3 times once a week (day 1, 8, 15). The next cycle started on~     day 29.~      Methods of Administration: HM30181A tablet was administered 1hour prior to the medication of~     paclitaxel~   "
158517|NCT01491191|"~     Postsurgical pain becomes chronic when it lasts more then two months after surgery. A~     neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates~     after urologic and gynecologic surgeries.~      Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors~     release, without adverse events.~      The investigators assume that perioperative administration of PEA can reduce chronic~     postsurgical pain incidence of patients undergoing to urologic and gynecologic elective~     surgery.~   "
158518|NCT01491178|"~     To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with~     nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic~     embolism (SEE).~   "
158519|NCT01491165|"~     Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are~     high cost, risk and immune rejection and other issues. Umbilical cord mesenchyma stem cell~     with self-and directed differentiation capacity can effectively rescue experimental liver~     failure and contribute to liver regeneration, which suggests the feasibility of stem cell~     transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma~     stem cell transplantation through interventional procedures in patients liver cirrhosis will~     be evaluated.~   "
158520|NCT01491152|"~     Cerebral Palsy (CP) is the most common cause of physical disability in childhood. Up to day~     the investigators have treated children diagnosed cerebral palsy with side-alternating whole~     body vibration (System Galileo®) from the age of two years on. Considering verticalisation~     (standing and walking) at about 12 months of age in a normal developing child the~     investigators suggest the introduction of verticalisation with whole body vibration to a~     child with CP at this early age in order to enhance motor development and participation.~      In this pilot study the investigators will test the feasibility and the effect on motor~     development of whole body vibration in children with CP from 12 months of age. The~     investigators will investigate the effect of whole body vibration on motor performance,~     independence in all day living situations, quality of life and contractures compared to a~     control group.~   "
158521|NCT01491139|"~     The aim of this study is to find the safe dose and best dosing schedule of olaparib to give~     in combination with cisplatin based chemoradiotherapy (CRT) in patients with locally advanced~     head and neck cancer. The dose decided on in this part of the study will become the~     recommended dose for the randomised Phase II trial.~   "
158522|NCT01491126|"~     The investigators study aim is to determine whether there is a any advantage in starting with~     upper or lower endoscopy. The main study objective will be the amount of analgesia needed for~     sustaining the examinee's comfort during the exams. Secondary endpoints will rate of~     detection of significant pathologies, total time of procedure, examinee's tolerance, time to~     recovery and examinee's satisfaction.~   "
158523|NCT01491113|"~     This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally~     administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in~     Japanese subjects with various degrees of impaired renal function.~   "
158524|NCT01491100|"~     Study assessing cognitive function and physical activity in people with relapsing remitting~     multiple sclerosis.~   "
158525|NCT01491087|"~     The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at~     2, 3, and 4 months of age in order to meet the regulatory requirements for the license~     renewal as for any other product registered in China, and to generate additional clinical~     data using the three-dose primary vaccination schedule in some other Chinese provinces.~      Primary Objective~        -  To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in~          the study population.~   "
158526|NCT01491074|"~     Acute coronary syndromes (ACS) are still associated with high morbidity and mortality,~     despite several improvements in their management. This may indicate that important pathogenic~     mechanisms contribute to both stable and unstable atherosclerotic disease mechanisms.~      Based upon previous research, the investigators believe that providing a block in the~     damaging inflammatory loop though short term inhibition of Interleukin-6 receptor signalling,~     could be an attractive therapeutic target in ACS; and of particular interest in patients with~     non-ST elevation myocardial infarction (NSTEMI), a disease often characterized by widespread~     coronary inflammation with multiple unstable plaques.~      The investigators hypothesize that a single administration of the anti-Interleukin 6 receptor~     antagonist Tocilizumab, in patients with NSTEMI, may interrupt the self-perpetuating~     inflammatory loops which could improve plaque stability, with potential secondary beneficial~     effects on myocardial damage.~      This will be investigated in a randomized, double blind, placebo-controlled study, including~     a total of 120 patients.~   "
158527|NCT01491061|"~     It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7~     days can significantly reduce procedural myocardial injury in elective percutaneous coronary~     intervention (PCI). The investigators tested the hypothesis that twice overnight high-dose~     ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage~     similarly to long-term pre-treatment with standard doses.~   "
158530|NCT01491022|"~     The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in~     Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple~     sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit~     from this medication and have major improvements in gait after taking this medication.~     However, this medication was never studied in Parkinson's disease. This study aims to learn~     about possible benefits of AMPYRA in Parkinson's disease (PD).~   "
158531|NCT01491009|"~     The aim of the study was to compare the effects of remifentanil-dexmedetomidine and~     remifentanil-midazolam with mini-mental state examination (MMSE) in monitored anesthesia care~     (MAC) patients undergoing cystoscopy.~   "
158532|NCT01490996|"~     Oral curcumin (complex C3, Sabinsa Corp, Utah) will be given to patients with inoperable~     colorectal metastases who will be commencing standard care oxaliplatin-based (FOLFOX)~     chemotherapy for up to 12 cycles(approximately 6 months) of treatment.~      Primary measurements focus on safety and tolerability. These will be recorded in real-time~     and report the number and severity of adverse events.~      Secondary measurements will include efficacy, (measured by response rate with RECIST and~     overall survival in months) supported by biomarker analysis.~   "
158533|NCT01490983|"~     This study is being conducted in a population of patients with chronic phase Chronic Myeloid~     Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral~     cancer drugs.~   "
158534|NCT01490970|"~     Sarcoma Database~   "
158535|NCT01490957|"~     Functional Assessment of Cancer Therapy - Bone Marrow Transplant~   "
158536|NCT01490944|"~     The study is a clinical trial to assess the effectiveness of Vitamin B12 supplementation~     along with Iron Folic Acid (IFA) in combating anaemia. Adolescent anaemic girls will be~     randomly divided into two groups.~        -  Group 1: IFA weekly supplementation along with Information, Education, Communication~          sessions~        -  Group 2: IFA + Cyanocobalamin weekly supplementation along with Information, Education,~          Communication sessions~      Duration of supplementation: 6 months~   "
158537|NCT01490931|"~     The surgical placement of dental implants is presently a common procedure performed by oral~     surgeons, periodontists, and general dentists. The surgery can be performed under local~     anesthesia and involves the incision of soft tissue to expose the underlying bone,~     preparation of the implant site using a specialized surgical drill, and.screwing the implant~     into bone using a specialized headpiece. Dental implant patients experience postoperative~     pain yet there are no studies in the literature which have evaluated the efficacy of~     analgesics in this patient population. The current pilot study will evaluate the analgesic~     effects and tolerability of a recently FDA-approved analgesic formulation of intranasal~     ketorolac (SPRIX®) in 25 patients who have 1 - 3 dental implants surgically placed. Patients~     will self administer the ketorolac nasal spray (one spray in each nostril, 31.5 mg total~     dose) when their postoperative pain reaches at least a moderate severity. Pain intensity and~     pain relief scores will then be recorded every 20 minutes for the first hour, at 1.5 and 2~     hours and then hourly through 6 hours on a validated analgesic diary. Side effects will be~     recorded when and if they occur. Patients will then transition to a multi-dose phase where~     they will be allowed to dose with ketorolac as indicated in the package insert (up to 4 times~     per day for 5 days). Patients will record the time of each dose, a daily assessment of~     overall efficacy and side effects, and the use of any rescue medication (acetaminophen 650~     mg) on a take home diary.~   "
158538|NCT01490918|"~     Primary objective To evaluate the efficacy of Acarbose added on top of Metformin and~     Sitagliptin that were combinedly administered to subjects with type-II diabetes, along with~     placebos.~      Secondary objectives~        1. To compare a Metformin-Sitagliptin combination and a Sitagliptin-Acarbose combination in~          efficacy~        2. To evaluate the 6-month efficacy of Acarbose added on top of the Metformin-Sitagliptin~          combination~   "
158539|NCT01490905|"~     This research protocol will compare Theramine to a non-steroidal anti-inflammatory drug~     (NSAID) in the treatment of chronic back pain. The study will examine the efficacy and~     tolerability of Theramine alone in patients with chronic back pain in comparison to the~     NSAID, Ibuprofen, and the co-administration of Ibuprofen with Theramine.~   "
158540|NCT01490892|"~     This is a non-randomized trial of 450 women with a breast abnormality, who are scheduled for~     a breast biopsy of this abnormality. The study will be conducted at two clinical sites. The~     primary objective of this trial is:~      To evaluate if quantitative 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging~     (HI) can improve the characterization of benign and malignant breast masses (independently or~     in combination with other imaging modes) compared to x-ray mammography, fundamental grayscale~     ultrasound (US) or power Doppler imaging (PDI).~      The secondary aim of this trial is:~      To compare quantitative (bifurcations & vessel length) and semi-quantitative (blood pool &~     parametric imaging) measures of the vascular morphology of breast lesions determined by~     pathology and by SHI.~   "
158541|NCT01490879|"~     This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The~     study is being done to determine if Nexagon® plus standard of care is more effective than~     placebo plus standard of care. Standard of care will include debridement of the ulcer,~     standardized dressings and standardized off-loading using a Removable Cast Walker.~   "
158542|NCT01490866|"~     This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent~     maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients~     with mCRC.~   "
158543|NCT01490853|"~     Objectives~      This is an observational study aimed at updating the overall survival (OS), the progression~     free survival (PFS) to accelerated-blastic (AB) phase and the complete cytogenetic response~     (CCgR) duration of the CML patients who between 1986 and 2001 were treated with an IFN based~     therapy (either alone or in combination) and who obtained a CCgR. It also aims at analysing~     the clinical and biological features of this selected cohort of patients with persisting CCgR~     after treatment with IFN.~      Study design This study is an observational retrospective multicenter study.~      Assessment and Follow-up Patients' demographic data and retrospective collection of CML~     cytogenetic and molecular data will be reported in the Assessment and Follow-up FORM.~      In this FORM the events related to therapy, disease and survival will also be reported.~      Duration of the study:~      The recruitment period is estimated in approximately 2 years.~   "
158544|NCT01490840|"~     This study evaluated the effect of an individualized web-based physical training in~     fingolimod -treated patients.~   "
158547|NCT01490801|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients~     with Epstein-Barr virus positive Hodgkin lymphoma.~   "
158548|NCT01490788|"~     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for~     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for~     bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102~     2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision~     and decreased potential for morning grogginess) and to compare the bio-availability of~     TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.~   "
158549|NCT01490775|"~     This study is being conducted in a population of patients with chronic phase Chronic Myeloid~     Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral~     cancer drugs.~   "
158550|NCT01490762|"~     This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and~     effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.~   "
158551|NCT01490749|"~     The purpose of this study is to test the drug RAD001 in combination with another chemotherapy~     drug, Carboplatin, as well as radiation therapy in the treatment of esophageal cancer.~     Because RAD001 has not been used in this combination before, it is not clear which dose will~     be best when used in combination.~      The standard of care for patients who have esophageal cancer that has not moved to other~     areas of the body (non-metastatic) includes a combination of chemotherapy, radiation therapy~     and possibly surgery. If the patient chooses to participate in this study, the patient will~     receive chemotherapy and radiation therapy. The patient will possibly also have surgery to~     have the cancer removed. This decision will be made by the treating physicians. All of the~     chemotherapy the patient will receive on the study is considered standard chemotherapy for~     esophagus cancer. The investigators do not know as of yet if the drug called RAD001 will help~     improve the treatment for patients with this disease. RAD001 is a pill that has been used in~     many other types of cancer and has been proven to be effective in other cancers such as~     kidney cancer.~   "
158552|NCT01490736|"~     The purpose of this study is to determine the safety of photodynamic therapy (PDT) with~     lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne.~   "
158553|NCT01490723|"~     The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan)~     to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine),~     followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of~     this combination will also be studied.~      Two (2) forms of ibritumomab tiuxetan will be used in this study. 90Y-ibritumomab tiuxetan is~     designed to attach to lymphoma cells and destroy the cells using a radioactive particle that~     is attached to it. 111In-ibritumomab tiuxetan is like 90Y- ibritumomab tiuxetan, but the~     radioactive particle that is attached to it does not kill lymphoma cells. The radioactive~     particle makes the drug able to be seen inside your body. It is being used in this study to~     predict how fast the study drug will travel in the body and how long the drug stays in the~     body.~      Rituximab is designed to attach to lymphoma cells, which may cause them to die.~      Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.~      Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may~     increase the likelihood of the cells dying.~   "
158554|NCT01490710|"~     Despite spectacular advances since the 90s mechanical ventilation used in intensive care~     units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung~     parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a~     significant morbidity and mortality.~      NAVA (Neurally Adjusted Assist Ventilation) ventilatory support, provides synchronous~     support, proportionate to patient's respiratory efforts. More physiological, this mode~     would decline its efficacy on patient hemodynamic response. However, to date, no study has~     focused on hemodynamic impact of NAVA. This is precisely the purpose of NAVADYN11 study,~     which aims to assess NAVA efficacy on cardiac index in pediatric intensive care unit.~   "
158555|NCT01490697|"~     Despite substantial therapeutic advances, Posttraumatic Stress Disorder (PTSD) remains~     difficult to treat. One promising new area of research is in post-reactivation pharmacologic~     intervention, which is based upon the concept of blockade of memory reconsolidation. Recent~     animal research suggests that reactivation (retrieval) of a stored memory can return it to a~     labile (alterable) state from which it must be restabilized in order to persist. This process~     is called reconsolidation, and various drugs have been found to block it in animals. This~     blockade may lead to a weakening of the original memory trace.~      The aim of this study is to pilot the effect of mifepristone on physiologic responding during~     traumatic imagery. Although mifepristone is widely and safely used to cause a medical~     abortion, it is also a powerful stress hormone receptor blocker. These stress hormones,~     called glucocorticoids, may enhance memory (re)consolidation. Indeed, a recent study in~     animals reported that mifepristone blocked reconsolidation of context-conditioned fear in~     rats.~      Reconsolidation blockade is a two-stage process. First, the memory must be destabilized by~     recalling it. Second, reconsolidation of the memory must be blocked by a drug. Memory traces~     formed under stressful conditions may resist destabilization and thus are inaccessible to~     reconsolidation blockers. However, when a reconsolidation blocker was paired with~     d-cycloserine (DCS) in animals that had been trained under stressful conditions,~     reconsolidation blockade became successful. These results suggest that DCS promotes the~     destabilization of resistant memory traces. The traumatic memories of individuals with PTSD~     may be particularly resistant to destabilization. Therefore, this study will compare~     mifepristone paired with DCS to placebo controls.~      The same script-driven traumatic imagery method validated in previous studies of propranolol~     in this lab will be used. Briefly, subjects with PTSD will describe their traumatic event~     during a script preparation session, which will reactivate the memory. They will then receive~     a) mifepristone and DCS or b) placebo. A week later, they will engage in script-driven mental~     imagery of their traumatic event while physiologic responses (heart rate, sweating, etc) are~     measured. This is a pilot study so there are no formal hypotheses. The aim is to estimate~     effect sizes for mifepristone and to compare them with effect sizes for propranolol from this~     lab's previous work.~   "
158556|NCT01490684|"~     Epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in~     Saudi Arabia is not well studied. This observational study objectives include to determine~     the epidemiology, risk factors and outcomes of invasive Candida infection in critically ill~     patients in Saudi Arabia.~   "
158557|NCT01490671|"~     Preliminary research has shown that a vaginal gel containing the antiretroviral (ARV) drug~     tenofovir may reduce the risk of HIV infection in women when used near the time of sexual~     intercourse. This study will evaluate the safety of 1% tenofovir gel in HIV-uninfected~     pregnant women and their newborns when the gel is used once a day for a period of 28 days at~     a designated time during pregnancy.~   "
158558|NCT01490658|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare repaglinide and metformin as co-administered tablets and as a combination tablet.~   "
158560|NCT01490632|"~     This is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib~     in the treatment of participants with moderate to severe, chronic plaque psoriasis as~     assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety~     assessments.~   "
158561|NCT01490619|"~     Adolescents with type 1 diabetes are at increased risk for depressive symptoms, poor coping~     and problem-solving skills, poor regimen adherence, and negative diabetes-specific health~     outcomes. Although a handful of psychological interventions targeting adolescents' poor~     behavioral and emotional functioning demonstrate beneficial effects on disease management and~     outcomes, no prevention programs exist that equip adolescents with behavioral skills and~     cognitive strategies necessary to reduce these risks. Therefore, the proposed research will~     test whether a diabetes-specific adaptation of a resilience promoting, depression-prevention~     intervention for adolescents with type 1 diabetes will reduce both the risk of poor~     psychological functioning and the risk of negative health outcomes over time.~   "
158562|NCT01490606|"~     A. Background.~      Patients with osteoarthritis (OA) of the knee, suffer from a combination of pain, stiffness,~     joint instability, swelling and muscles weakness. This leads to decrease in quality of life,~     Active Daily living (ADL) and increase of medical services consumption in the community. OA~     of the knee, Is one of the world's common musculoskeletal disorder (18% among women and 10%~     among men). 80% of patients with OA of the knee suffer from decrease in mobility and 20% of~     them suffer an inability to perform everyday activities.~      Physical therapy training includes exercises for OA patients (Mild to Severe degree) is the~     cornerstone of non medicinal treatment. This training aimed to pain reduction, improved~     functioning and participation in family and working social life. Physical training with~     exercises can enhance physical capabilities such as: muscular strength, range of motion,~     balance, proprioception and cardiovascular performance. Other benefits are improving~     mobility, reducing risk of falls and body weight and improvement in psychological condition.~      B. Purpose~      The purpose of this research is to check the effectiveness of treatment in the framework of~     knee Osteoarthritis project compared to conventional Physical therapy in physical~     functioning, pain and quality of life scales, among patients over the age of 60 who suffer~     from OA of the knee .~      C. Research method~      A comparative non blinded, clinical trial will be conducted. This research will include 60~     independent patients divided into equal groups: Intervention group will be trained in knee~     Osteoarthritis project (in which patients receive 6 individual treatments and 6 Group~     treatments). Control group will be treated with conventional physical therapy, which includes~     12 individual treatments. Effect of the treatment will be evaluated by: 1. WOMAC~     questionnaire- used to evaluate function and pain. 2. EQ-5D questionnaire for evaluating the~     quality of life. 3. Time up and go test- a Common functional test. This Questionnaires and~     test will be Performed before and after the study.~      D. Study hypothesis~      Physical therapy treatment within the framework of knee Osteoarthritis project is favor~     than the treatment of the conventional Physical therapy. Therefore the investigators expect~     much improvement in terms of pain, physical functioning and quality of life among~     intervention group compared to control groups.~   "
158563|NCT01490593|"~     The purpose of this study is to establish an eye injury registry to assess the mechanisms and~     outcomes of significant eye injuries occurring in Canada. The epidemiologic data will~     determine where public health strategies should be directed to prevent future eye injuries.~   "
158564|NCT01490580|"~     Multicenter double blind randomized controlled trial comparing atropine+propofol vs~     atropine+atracurium+sufentanil as a premedication prior to endotracheal intubation of the~     neonate.~      Primary outcome: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes:~     number of attempts, duration of the procedure, changes in physiologic parameters, short- and~     long-term neurodevelopmental outcome.~      Hypothesis: atropine + propofol compared to atropine+atracurium+sufentanil will~     significantly reduce the frequency of severe hypoxemia.~   "
158565|NCT01490567|"~     The objective of the study was to study the effects of donepezil on cognition in patients~     with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled~     trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with~     schizophrenia.~   "
158566|NCT01490554|"~     The purpose of this study is to evaluate the presence of skin changes after grafting of~     autologous fibroblasts by means of biophysical, histological, immunohistological, gene~     expression, glycosaminoglycan, and sensitivity analyses.~   "
158567|NCT01490541|"~     The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a~     recommendation for Thai population.~      Objective:~      To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM)~     patient in order to propose the appropriate recommendation for Thai people.~      Research Design:~      Single center, retrospective-cohort study.~   "
158568|NCT01490528|"~     There is little data published on the long term durability of infliximab in pediatric~     patients. In particular a focus on durable remission, frequency of dose/frequency change and~     switch within class. Moreover 10 years of safety experience is rarely reported in children.~      The overall objective is to evaluate the persistence of infliximab as well as dosing~     strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab~     Regarding persistence of infliximab the investigators will be focusing on the proportion of~     patients who continue to have a durable response or remission to infliximab.~      The investigators will be assessing this by measuring the frequency of dose escalation,~     proportion of patients needing frequency change and proportion of patients switched to~     adalimumab or certolizumab.~      Safety outcomes will focus on frequency of malignancies, infections and immunogenecity~   "
158569|NCT01490515|"~     Metabolomics was recently introduced in human IVF for non-invasive identification of viable~     embryos with the highest developmental competence. The investigators intended to investigate~     if embryo assessment using non-invasive metabolomic profiling leads to increased implantation~     rates compared to routine morphology evaluation alone.~   "
158570|NCT01490502|"~     Low vitamin D levels have been shown to increase a person's risk of developing multiple~     sclerosis (MS), and patients with MS who have lower vitamin D levels are at increased risk of~     having attacks. However, it is not known if giving supplemental vitamin D to those with MS~     reduces the risk of attacks, and some research suggests that vitamin D could even be harmful~     to people with MS.~      In this clinical trial, patients with relapsing-remitting MS will receive high-dose or~     low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate.~     Patients will be evaluated for two years, and the effect of high-dose vitamin D~     supplementation on the rate of MS attacks and on the number of new lesions and change in~     brain volume on MRI will be determined. Establishing this association will have major~     implications for the treatment of individuals with MS throughout the world.~   "
158571|NCT01490489|"~     The purpose of this study is to assess the potential prognostic value of seric concentrations~     of EG-VEGF for Pre-eclampsia and/or intrauterine growth restriction and will allow checking~     whether plasma levels of EG-VEGF at 14-18 weeks of gestation could be proposed as prognostic~     marker for preeclampsia.~   "
158572|NCT01490476|"~     The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth~     of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients.~   "
158574|NCT01490450|"~     The purpose of this study is to characterize the safety, efficacy and dose response of~     BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to~     Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying~     anti-rheumatic drugs (DMARDs).~   "
158575|NCT01490437|"~     Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single~     agent as first-line and second-line treatment for advanced urothelial carcinoma. The response~     rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is~     one the most active chemotherapeutic agents in urothelial cancer, frequently used as~     combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate,~     vinblastine, adriamycin, and cisplatin).~      Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung~     cancer with highly favorable toxicity profile.~      This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced~     urothelial carcinoma.~   "
158576|NCT01490424|"~     Triggering receptor expressed on myeloid cells-1 (TREM-1) is a cell surface receptor~     expressed on neutrophils and monocytes. TREM-1 acts to amplify inflammation and serves as a~     critical mediator of inflammatory response in the context of sepsis. Blocking of TREM-1 can~     protect against sepsis in mice. This study was designed to investigate whether TREM-1 genomic~     variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with~     TREM-1 gene of four exons by PCR sequencing. When analyzing the results of sequencing, we~     found two gene polymorphisms located in exon-2 and exon-4, respectively. Compare with the~     NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous~     variation rs2234237（Ser25Thr）, the other one located in exon-4 is synonymous variation~     rs2234246. Two common polymorphisms (rs2234237,rs2234246) within the TREM-1 gene were~     detected in 80 patients with severe sepsis and in 80 healthy control subjects. This study was~     explored that whether or not polymorphisms detected within the TREM-1 gene may play a major~     role in the predisposition to prognosis of sepsis in a Chinese Han cohort.~   "
158577|NCT01490411|"~     The purpose of this study is to find out if rBet v1-FV works to relieve Seasonal Allergic~     Rhinitis symptoms compared to Placebo (an inactive substance that looks like rBet v1-FV and~     also contains Aluminum Hydroxide but does not contain the experimental drug). rBet v1-FV is a~     vaccine that works by exposing your immune system to something that resembles birch. This~     vaccine may help to lessen your allergy symptoms during the natural birch season.~   "
158578|NCT01490398|"~     In ASCOT study, lipid lowering with a statin provided additional beneficial effects in~     hypertensive patients with average levels of serum total cholesterol. However, the underlying~     mechanism of statins to improve clinical outcomes in hypertension is unclear and the effect~     of statins on coronary flow reserve (CFR) has not been examined in hypertensive patients.~     Therefore, it is clinically important and timely project to measure CFR non-invasively using~     echocardiography and to elucidate the mechanism of clinical benefits of statins in~     hypertensive patients with cardiovascular risk. The investigators try to evaluate the effect~     of rosuvastatin on CFR by measuring the change of CFR after 1 year treatment of rosuvastatin,~     and to correlate CFR with LDL-cholesterol and CRP.~   "
158579|NCT01490385|"~     LED Phototherapy will increase the velocity of Orthodontic tooth movement.~   "
158580|NCT01490372|"~     Gestational Diabetes Mellitus (GDM) has long been known as leading to macrosomias, neonatal~     hypoglycemias and other complications which are treatable and preventable. Nowadays, GDM is~     recognized as an entity with long-term serious sequels to the mother (GDM is considered a~     forerunner of type 2 diabetes) and her offspring. Indeed, according to the programming~     hypothesis, GDM sets the stage for metabolic syndrome, obesity, type 2 diabetes and~     hypertension. However, these cross-sectional studies failed to control for maternal disease~     history and genetic background although heredity is a major epidemiology risk factor of type~     2 diabetes. Also, studies usually refer to traditional markers such as BMI, blood pressure,~     lipids profile and oral glucose tolerance test (OGTT); none explored inflammatory biomarkers~     and adipokines in-depth, despite the possible link between their presence and the development~     of metabolic and cardiovascular diseases in GDM offsprings.~      Exclusion of genetic confounding factors will help establish the role of GDM as an~     independent marker of cardiometabolic risk in GDM offspring. It is highly relevant to~     identify GDM as a risk factor for cardiometabolic diseases, given the worldwide obesity~     epidemic, the alarming prevalence increase of GDM and its serious sequels to both mother and~     offspring.~   "
158581|NCT01490359|"~     Sub-Saharan Africa has about 10% of the world's population, but was home to more than 60% of~     all people living with HIV in 2003. South Africa continues to have the largest number of~     people living with HIV in the world, and as in other parts of sub-Saharan Africa,~     heterosexual exposure is the primary HIV transmission category. Worldwide, efforts to stem~     the spread of HIV among heterosexuals have stressed the impact of HIV on women. Oft-cited~     statistics indicate that about half of all people living with HIV are women. The strategies~     typically offered to address the impact of HIV on women are interventions with women. An~     alternative approach to addressing women's risk of heterosexual transmission of HIV, one that~     would be an important complement to the predominant approach, is focusing on men. By reducing~     sexual risk behavior of men, it should be possible to reduce rates of HIV in both men and~     women. The rates in men would decline because they are the recipients of the intervention;~     rates in women would decline because they have sex with men. Interventions aimed at men could~     take into account the power that men have in sexual decision-making and risk taking. However,~     whether one considers the US literature or the international literature, few randomized~     controlled trials of HIV/STD risk-reduction interventions have focused on heterosexual men.~     Accordingly, the purpose of this research is to develop and test the efficacy of an~     intervention to curb HIV/STD risk-associated behavior in South African men who have sex with~     women. A cluster-randomized controlled trial design will be used to reduce the potential for~     contamination between treatment arms that would be present if individuals were randomized. An~     attention control group will be used to control for Hawthorne effects, special attention, and~     group interaction. Matched pairs of neighborhoods in Black townships in Eastern Cape~     Province, South Africa similar on key characteristics will be created, 22 pairs will be~     randomly selected, and men will be recruited. One neighborhood in each pair will be randomly~     assigned to each of the 2 study arms. We hypothesized that men who receive a culturally~     appropriate theory-based HIV/STD risk-reduction intervention will be more likely to report~     consistently using condoms during intercourse in the 12-month post intervention period than~     will men who receive an attention-control intervention, adjusting for baseline condom use.~   "
158582|NCT01490346|"~     The aim of this study is to find out why HIV continues to make copies in people taking HIV~     drugs. The investigators want to know if the medications most people use to treat HIV get~     into the lymphatic tissue where HIV persists.~   "
158592|NCT01490203|"~     The purpose of this study is to determine whether the global and segmental hepatic uptake and~     excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver~     function test results in the patients with Hepatocellular Carcinoma (HCC) before major~     hepatic resection or radiofrequency ablation (RFA).~   "
158593|NCT01490190|"~     This study will collect information on cycle control, acceptability and tolerability of the~     vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.~   "
158583|NCT01490333|"~     Cardiovascular disease (CVD) and diabetes occur commonly among Native Americans (NA), and are~     leading causes of death among northern US NAs. Moreover, low vitamin D status occurs commonly~     in this same population. An increasing amount of evidence indicates a correlation between low~     vitamin D status and CVD and diabetes by contributing to a heightened pro-inflammatory~     environment within the endothelial lining of blood vessels leading to atherosclerotic~     disease, and an impaired sensitivity to insulin leading to diabetes. Our fundamental~     hypothesis is that low vitamin D status is a risk factor for CVD by causing a proinflammatory~     milieu, thereby leading to endothelial dysfunction. Additionally, the investigators~     hypothesize that vitamin D supplementation will reduce inflammation, thereby restoring~     endothelial function and ultimately reducing CVD risk.~   "
158584|NCT01490320|"~     The American Academy of Pediatrics recommends that parents receive anticipatory guidance~     about violence prevention as part of the routine well child visit. Educational resources are~     needed to help physicians routinely provide these important anticipatory guidance messages.~     In this study, consecutive parents will be exposed to routine anticipatory guidance messages~     before the well child visit with the physician. After the clinic visit, parents will be~     invited to participate in a research study to determine if they plan any changes at home. The~     key research question of this study is:~      Can a brief multimedia program (i.e. Play Nicely program) and/or the AAP Connected Kids~     brochure, entitled, Pulling the Plug on TV Violence, help parents develop plans to~     decreases their children's exposure to violence in the media (e.g. less media time, no TV in~     the bedroom)?~   "
158585|NCT01490307|"~     The goal of this project is to empirically refine and improve a comprehensive family-centered~     prevention strategy for reducing and preventing adolescent substance use and other problem~     behaviors. This project builds on 15 years of programmatic research underlying the~     development of the Family Check-up model (FCU), originally referred to as the Adolescent~     Transitions Program (ATP; Dishion & Kavanagh, 2003), but later expanded as a general approach~     to mental health treatment for children from ages 2 through 17 (Dishion & Stormshak, 2007).~     The FCU model is a multilevel, family-centered strategy delivered within the context of a~     public school setting that comprehensively links universal, selected, and indicated family~     interventions. Previous research and the investigators' practical experience working in~     school settings indicate that the intervention strategy needs improvement in 3 critical areas~     to build on previous significant effects and to enhance the potential for future~     dissemination and large-scale implementation:(a) improve the feasibility of both the~     universal level and the indicated level of the intervention by broadening the intervention~     components and systematically embedding these components into the current behavioral support~     systems in the schools; (b) address the transition from middle school to high school, with~     special attention to academic engagement and reduction of deviant peer clustering; and (c)~     explicitly incorporate principals of successful interventions with families and young~     adolescents of diverse ethnic groups into both the universal and indicated models. An~     additional general goal of this study is to develop, test, and refine a set of research-based~     instruments that facilitate evaluation, training, implementation, and monitoring of~     intervention fidelity to maximize the potential success of implementation and large-scale~     dissemination.~      Participants include 593 youth and their families recruited from the 6th grade in three~     public middle schools in Portland, OR. Families were randomly assigned to receive either the~     FCU intervention model or treatment as usual. Assessments were collected for 5 years through~     the 10th grade. High school transition planning and intensive intervention efforts occurred~     in Grades 7-9.~      The investigators tested the hypothesis that the FCU intervention will reduce the growth of~     problem behavior and substance use through the enhancement of family management and parent~     involvement in school.~   "
158586|NCT01490294|"~     The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac~     Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT~     examination in terms of diagnostic quality.~      For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg~     body weight are administered. A study participant receives the respective dose twice i.e. at~     rest and at stress using Adenosine (which puts circulation into a state of stress similar to~     that of physical exercise). The time between both injections is 10-15 min.~      The total imaging time is about 45 min.~   "
158587|NCT01490281|"~     Background The Al-Andalus physical activity intervention study is a randomised control trial~     to investigate the effectiveness of a land- and water-based exercise intervention for~     reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness~     and pain-related measures, body composition, functional capacity, physical activity and~     sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive~     function (secondary outcomes) in women with fibromyalgia.~      Methods One hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited~     from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will~     be randomly assigned to a usual care (control) group (n=60), a water-based exercise~     intervention group (n=60) or a land-based exercise intervention group (n=60). Participants in~     the usual care group will receive general physical activity guidelines and participants~     allocated in the intervention groups will attend three non-consecutive training sessions (60~     minutes each) per week during 24 weeks. Both exercise interventions will consist of aerobic,~     muscular strength and flexibility exercises.~      Discussion The investigators study attempts to reduce the impact of fibromyalgia and improve~     patients' health status by implementing two types of exercise interventions. Results from~     this study will help to assess the efficacy of exercise interventions for the treatment of~     fibromyalgia. If the interventions would be effective, this study will provide low-cost and~     feasible alternatives for health professionals in the management of fibromyalgia. Results~     from the Al-Andalus physical activity intervention will help to better understand the~     potential of regular physical activity for improving the well-being of women with~     fibromyalgia.~   "
158588|NCT01490268|"~     The purpose of this study is to determine generation of a target controlled infusion model~     for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned~     open heart surgery, during which the strong analgesic, sufentanil, was used.~   "
158589|NCT01490255|"~     No previous study has assessed the potential of ranolazine to interfere with levels of~     platelet reactivity in patients with coronary artery disease who are treated with dual~     antiplatelet therapy.~      Aim of this study is to compare the pharmacodynamic effects of maintenance doses of~     ranolazine versus amlodipine on platelet reactivity in patients with coronary artery disease~     who are treated with dual antiplatelet therapy.~   "
158590|NCT01490229|"~     Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals~     (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will~     compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in~     statin-intolerant patients treated with percutaneous coronary intervention.~   "
158591|NCT01490216|"~     The purpose of this study is to evaluate ideal dose or lisdexamfetamine and tolerability,~     plus reduction in cocaine use and craving.~   "
183207|NCT01166776|"~     The purpose of this study is to isolate Umbilical cord Wharton's jelly matrix to be used as a~     scaffold for tissue regenerative applications, including avascular necrosis.~   "
158594|NCT01490177|"~     The Primary Objective of the study is to develop a customized regimen for oral immunotherapy~     that reflects what the subject is allergic in a clinically significant way (i.e., the~     offending food allergen is defined as a food allergen with a positive skin test or positive~     specific IgE and a positive DBPCFC). Therefore, the investigators prefer that both single and~     multiple food allergy subjects are included in the study.~   "
158595|NCT01490164|"~     Corrective surgery for scoliosis can result in prolonged operating room time and significant~     blood loss. The investigators goal is to determine what the transfusion requirements are for~     young adults undergoing spinal surgery for scoliosis and what other intra-operative factors~     influence the amount of blood and blood products used. The investigators will used the~     information obtained to improve the management of patients undergoing corrective surgery for~     scoliosis.~   "
158596|NCT01490151|"~     The purpose of this study is to evaluate a treat-to-range automated insulin management system~     using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in~     individuals with type 1 diabetes.~   "
158597|NCT01490138|"~     Invasive fungal infection (IFI) is a disease usually occurred in the patients with~     compromised immune condition, such as acute leukemia, allogeneic stem cell transplantation or~     long term immune suppression treatment with the incidence increasing over last decades. Given~     the introduction of numerous anti-fungal agents and great advance has been made in recent~     years, IFI is still a dangerous disease with high mortality.~      Early diagnosis of IFI is still a problem challenging the physicians. Serum tests of~     β-D-Glucan are introduced to the diagnosis of IFI, which have the advantage of easy~     application. However, the value of this test in the monitoring of antifungal treatment~     remains unclear.~      The investigators perform this study to evaluate the correlation of the serum test results of~     β-D-Glucan test with the treatment response during the anti-fungal treatment, and hope to see~     that the results of serial serum tests are good predictive markers for treatment response.~   "
158598|NCT01490125|"~     This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe~     Chronic Obstructive Pulmonary Disease (COPD) patients.~   "
158599|NCT01490112|"~     This study is conducted in Asia. The aim of this study is to observe the safety and efficacy~     of insulin aspart (NovoRapid®) administered via vial and three different devices.~   "
158600|NCT01490099|"~     This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence~     between insulin detemir produced by the NN729 process and by the current process in healthy~     subjects.~   "
158601|NCT01490086|"~     The objective of this study is to evaluate the efficacy and safety of RP5063 relative to~     placebo for the treatment of schizophrenia or schizoaffective disorder.~   "
158602|NCT01490073|"~     Increasing ease of access of long-acting birth control methods, like intrauterine devices~     (IUDs), is an important way to reduce the risk of unintended pregnancy. Unfortunately, fear~     of IUD insertion in women who have not had children is common among health care providers and~     women alike, and this limits IUD use. To increase acceptance of this highly effective birth~     control method, there is a need to explore new, low cost, and easily applied methods to~     improve the insertion experience. This is a pilot study to evaluate the effectiveness and~     acceptability of nitroglycerin ointment applied vaginally to improve the IUD insertion~     experience for both patient and provider. The investigators hypothesis is that nitroglycerin~     ointment will decrease the pain associated with IUD insertion.~   "
158603|NCT01490060|"~     The goal of this clinical research study is to learn how different doses of fosaprepitant may~     effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to~     learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may~     be caused by chemotherapy. The safety of this drug will also be studied.~      Fosaprepitant is designed to block the natural substance in the brain that causes nausea and~     vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.~   "
158604|NCT01490047|"~     Assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of recombinant human~     tumor necrosis factor-α (rhTNF-α) when given as a single dose intravenously and in~     combination with liposomal doxorubicin in human subjects~   "
158605|NCT01490034|"~     Due to the rising incidence of obesity, much emphasis has been placed on identifying~     mechanisms of increased energy intake. At this point, the mechanisms responsible for the~     recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive~     influences, such as cognitive factors, may play a larger role in creating an energy surplus~     than previously thought. Expectations about the satiating effect of a food may override the~     post-ingestive influences in dictating further consumption. In addition, obese individuals~     may exhibit a decreased compensatory response to foods as compared to lean individuals.~      Understanding the effects of energy content, food form, and learning on satiation, satiety,~     and energy intake will allow for a greater understanding of the mechanisms of energy~     imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive~     effects. By utilizing foods with similar sensory properties, the acquired knowledge derived~     from ingesting these foods can be monitored by analyzing subsequent intake at the same meal~     and at subsequent eating occurrences. It is hypothesized that the liquid food form will~     elicit weaker dietary compensation; that is, energy intake at other eating events will not be~     adjusted to compensate for that food. In addition, it is posited that the lower energy food~     will cause lower compensation postprandially. By having participants consume the same test~     food daily over a two week learning period, it is thought that they will show improved~     dietary compensation when the initial testing is repeated due to learned associations between~     food properties and metabolism.~   "
158606|NCT01490021|"~     Episodic and working memory processes are the most affected cognitive domains in Alzheimer's~     Disease (AD) and its early stage, Mild Cognitive Impairment (MCI). Transcranial Magnetic~     Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing virtual~     and transient lesions, mimicking those observed in MCI. It has proven repeatedly its~     capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging~     data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability~     of TMS effects over time remains to be investigated. If proven to be a stable interfering~     challenge, TMS could be used to investigate the potential restoring effect of new medication~     in AD.~      The study is the pilot study of a larger clinical trial which aims to prove the utility of~     rTMS as a potential model for prediction of clinical efficacy using a combination of~     cognitive and neuroimaging endpoints.~   "
158607|NCT01490008|"~     Investigation of systemic catechin exposure following topically administered Veregen® 15%~     ointment in patients with external genital and perianal warts and following oral intake of a~     standardized green tea beverage in healthy subjects.~      Pharmacokinetic parameters for the main catechin EGCg used as a marker of overall catechin~     exposure following dermal administration in the patient group will only be calculated if~     sufficiently consistent data can be obtained e.g. sufficient plasma catechin concentrations~     to pharmacokinetically evaluate plasma profiles for plasma catechin concentrations.~      If applicable, a safety margin for ointment use might need to be established with respect to~     intolerable systemic exposures of catechins following application of Veregen® ointment.~      In treatment arm 1, patients with anogenital warts will apply Veregen® 15% ointment 250 mg~     three times daily: in the morning, at midday, and in the evening on the defined anogenital~     administration area (total dose of 750 mg/d) for one week .~      In treatment arm 2, healthy subjects will ingest 500 mL commercially available green tea~     beverage (Lipton® Green Limone distributed by PepsiCo Deutschland GmbH, Neu-Isenburg,~     Germany), three times daily in the morning, at midday, and in the evening (total dose of 1500~     mL/d) for one week.~      Plasma samples will be collected to aim for a complete pharmacokinetic assessment (over 24~     hours) on Days 1 and 2 at Visit 2 and on Days 7 and 8 at Visit 3 (one week after first~     dosing).~      To avoid any influence on overall systemic catechin exposure deriving from any other source~     than Veregen® or Lipton Green Tea, all subjects participating in the trial (patients and~     healthy volunteers) will be asked to follow a defined diet abstaining from food or beverages~     known to containing catechins (a list of all prohibited and allowed foods and beverages will~     be provided to all subjects).~      For concomitant medication, only paracetamol and oral contraceptives are allowed.~   "
158608|NCT01489995|"~     A 5-period crossover study to evaluate the effect of meal type and timing on migalastat HCl~     pharmacokinetics in healthy male and female subjects. Subjects will be randomly assigned to 1~     of 5 treatment sequences and will receive each treatment over the course of 5 weekly periods.~   "
158609|NCT01489982|"~     More than half of patients with Parkinson's have troubles with insomnia. There are several~     treatment options for insomnia that have been studied in the general population - however,~     the investigators don't know if these treatments work for patients with Parkinson's. It is~     possible that people with Parkinson's may have different treatment responses.~      The goal of this project is to test in a pilot study the tolerability and effectiveness of~     pharmacologic and non-pharmacologic treatments to improve insomnia in patients with~     Parkinson's disease. Each participant in this study will be wearing a wrist actigrapch and~     fill out the sleep diary. Three main treatment strategies will be tested: Placebo Light~     therapy, Cognitive behavioural therapy and active light therapy, and insomnia medications.~     The treatment that each person will receive first will be chosen randomly. If the first~     therapy has not been effective, participant may choose to re-enrol in the trial with one of~     the remaining two therapies.~   "
158610|NCT01489969|"~     This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo~     controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to~     receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to~     assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia~     patients aged 18-80 years, following the first two nights (immediate effect) and at the end~     of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency~     to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of~     treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The~     secondary endpoints are number of awakenings after sleep onset and the duration of wake after~     sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the study;~     mean of two consecutive nights recordings).~   "
158611|NCT01489956|"~     The purpose of this study is to test the oral tolerance of Keyhole Limpet Hemocyanin (KLH)~     and to determine if Immucothel by itself is strong enough to trigger the immune response. If~     not, Immucothel will be tested in combination with an adjuvant to determine if an adequate~     immune response can be seen.~   "
158612|NCT01489943|"~     The purpose of this study is to test the effects of study drug (GSK1605786) on the blood~     levels of multiple commonly used drugs that are given to measure how your liver breaks down~     the study drug. These commonly-used drugs are midazolam, pioglitazone, omeprazole, and~     rosuvastatin which will determine the effect of GSK1605786 on how the body breaks down~     (metabolizes) these commonly-used drugs. Blood samples for pharmacokinetic analysis of~     GSK1605786, and two metabolites, [GSK2635622 (CCX062) and GSK2656694 (CCX304)] and four probe~     substrates will be collected over a 24-hour period after administration. Safety will be~     assessed by the measurement of vital signs, cardiac monitoring, collection of adverse event~     assessments and laboratory tests.~   "
158613|NCT01489930|"~     Loss of skeletal muscle strength and skeletal muscle mass occurs with of aging. This~     are-related decline in skeletal muscle mass and skeletal muscle strength is a major~     underlying factor contributing to many of the metabolic disorders and frailty of the~     investigators rapidly expanding aging population. Endurance (aerobic) and resistance exercise~     training programs have been shown to effectively reverse the age-related decline in metabolic~     and contractile muscle functions. The investigators will measure synthesis rates of~     individual muscle proteins in 36 each of young (18-30 yrs) and 36 older (> 65 yrs) people to~     determine their response to 8 weeks each of endurance, resistance, combined endurance and~     resistance training, or placebo exercise training.~      Hypotheses.~        1. to measure fractional synthesis rates of multiple muscle proteins and identify those~          that are enhanced by an endurance exercise program~        2. to determine whether changes in protein synthesis in response to endurance exercise~          programs are dependent on age~        3. to measure fractional muscle synthesis rates of multiple muscle proteins and to identify~          those that are enhanced by a resistance exercise program~        4. to determine whether changes in protein synthesis in response to resistance exercise~          programs are dependent on age~   "
158614|NCT01489917|"~     The Provisional Heparin TherApy on Radial Artery Occlusion after transradial coronary~     angiography and patent Hemostasis (PHARAOH) study compares the strategy of standard a-priori~     heparin use in patients undergoing transradial coronary angiography to a strategy of~     provisional heparin administration only if patent hemostasis is not achievable.~   "
158615|NCT01489904|"~     The purpose of this study is to evaluate the safety and efficacy of botulinum toxin-A in~     salivary glands as a treatment for decrease drooling in patients with cerebral palsy and~     evaluate the long-term effects and tolerance . To assess whether patients with cerebral palsy~     have hypersalivation comparing with patients without treatment and healthy volunteers and if~     botulinum toxin may reduce the volume of drooling without altering the swallowing function.~   "
158616|NCT01489891|"~     The purpose of this study is to determine the efficacy of application of the anaesthesia~     topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in~     therms of dosage and side effect´s reduction overall.~   "
158617|NCT01489878|"~     In this prospective, observational, multicentric open study, the investigators will compare~     the acquisition rates of methicillin-resistant staphylococci (coagulase-negative~     staphylococci and Staphylococcus aureus) nasal carriage in community patients receiving an~     ambulatory antibiotic treatment by either a β-lactam (amoxicillin-clavulanate or penicillins~     M), a macrolide, a synergistin or a fluoroquinolone.~   "
158618|NCT01489865|"~     People are being asked to participate in this study who have metastatic pancreatic cancer~     (cancer that has spread to other parts of the body).~      The purpose of this study is to test the efficacy (effectiveness) of a new combination of~     drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with~     metastatic pancreatic cancer.~      ABT-888 inhibits an enzyme called PARP which helps to fix damaged DNA. By inhibiting this~     enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and~     will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.~   "
158619|NCT01489852|"~     The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of~     2 additional oocytes in GnRH antagonist protocol.~   "
158620|NCT01489839|"~     The primary purpose of the study will be to look for biological biomarkers to determine which~     people with gum disease will have a worsening of the disease. A second objective of this~     study will be to look at the effects of periodontal treatment on the levels of the biomarkers~     that are identified.~   "
158621|NCT01489826|"~     This study is a trial of Dexanabinol in patients with advanced solid tumours. The purposes of~     this protocol are to study different doses of the study drug to determine the maximum safe~     dose and to further understand the safety of the study drug; to understand what the body does~     to the study drug; to understand what the study drug does to the body and to measure any~     reduction in size of patients' cancer tumour(s).~      Dexanabinol is a synthetic cannabinoid derivative with reduced psychotropic potential which~     was initially investigated as a neuroprotective agent. Because of its method of action~     however it is thought that it may have the effect of destroying cancer cells by reducing the~     level of control on networks that prevent cancer cells dying.~   "
158622|NCT01489813|"~     Patients with non-invasive bladder cancer are often treated with intravesical therapy in~     order to prevent the recurrence of bladder cancer. Intravesical therapy can cause many lower~     urinary tract symptoms, which can limit the dose of therapy and therefore efficacy of~     treatment. There have been a number of studies that suggest a chemical found in soy beans may~     be able to help with these side effects. This chemical is called genistein and can be~     extracted and given to study subjects in pill form. In this study, the investigators would~     like to have patients placed into two different groups. One group would take genistein and~     the other group would take a placebo, a sugar pill that looks like the genistein pill. In~     doing this study the investigators hope to explore the findings from other studies to see if~     lower urinary tract symptoms are reduced and to see if recurrence rates for patients are~     affected by genistein. The study would take about four and a half months total.~   "
158623|NCT01489800|"~     Complications after radical cystectomy for bladder cancer range from 30-40%, many of which~     are related to bowel function. Patients usually wait to eat until return of bowel function,~     although there is evidence that after primary intestinal or colonic surgery, patients may~     take food ad lib immediately, and that this is is associated with lower complication rate and~     shorter length of stay. The investigators hypothesize that early access to oral enteral~     nutrition (food at will) after cystectomy and urinary diversion will reduce the complication~     rate both in-hospital and within 90 days after hospital discharge.~   "
158624|NCT01489787|"~     The purpose of this study is to assess the feasibility, safety and efficacy of High Intensity~     Focused Ultrasound (HIFU) patients undergoing hepatectomy for colorectal liver metastases.~     This is a phase I/II study.~   "
158625|NCT01489774|"~     Study objectives~        -  To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral~          doses of CJ-12406 in healthy male subjects.~        -  To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to~          healthy male subjects.~        -  To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406~          in healthy male subjects.~   "
158626|NCT01489761|"~     This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting~     stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime~     or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.~   "
158627|NCT01489748|"~     This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work~     capacity of participants with multiple sclerosis (MS) starting on this device. This study~     will also evaluate as secondary endpoints various patient-reported outcomes over the~     short-term (1 month), including adherence, treatment satisfaction and convenience, and the~     long-term (12 and 24 months), including adherence, persistence, quality of life (QOL),~     treatment satisfaction and convenience. It will also assess health resource utilization by MS~     participants starting on AVONEX PEN autoinjector, as well as overall safety/tolerability, and~     will correlate all secondary outcomes with the primary (i.e., work capacity).~   "
158628|NCT01489735|"~     There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to~     diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the~     specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the~     patient's life and help in choosing treatment of GERD, as well as direct assessment of~     treatment efficacy.~      In connection with mentioned above, this study is devoted to the estimation of possibility to~     use GerdQ in routine practice of Russian physicians.~   "
158629|NCT01489722|"~     The purpose of this open label study is to evaluate the safety, tolerability,~     pharmacokinetics, and efficacy of AZD1208 in patients with recurrent or refractory Acute~     Myelogenous Leukemia (AML). This study will have two parts. In Part A, patients will receive~     escalating doses to identify the maximum tolerated dose (MTD). In Part B, the efficacy of the~     maximum tolerated dose will be evaluated in a expanded group of patients.~   "
158630|NCT01489709|"~     This study is to evaluate the effect of Vesicare on quality of life (QOL) in female patients.~   "
158631|NCT01489696|"~     The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron~     and tamsulosin both alone and in combination.~   "
158632|NCT01489683|"~     When not using neuromuscular blocking agent, even at optimal dosage, target-controlled~     infusion (TCI) of propofol and remifentanil occasionally produce unsatisfactory intubating~     conditions. Therefore, the investigators evaluated that the effect of tracheal lidocaine on~     the intubating conditions for tracheal intubation during anesthesia induction of propofol and~     remifentanil TCI without neuromuscular blocking agent in day-case anesthesia.~   "
158633|NCT01489670|"~     This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ®~     0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are~     treated per routine clinical practice.~   "
158634|NCT01489657|"~     The purpose of this prospective observational study is to generate further insight into the~     numerous metabolic adaptations associated with sleeve gastrectomy surgery in obese subjects~     by profiled serum metabolites before and after the surgery and integrated metabolite changes~     with clinical data.~   "
158635|NCT01489644|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare repaglinide and metformin administered as an individual tablets with repaglinide and~     metformin administered as a combination tablet.~   "
158636|NCT01489631|"~     Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation~     and hospital discharge might be delayed. Recent research shows that intra-articular~     infiltration with local anesthetics and perioperative prescription of gabapentin can improve~     outcome.~      Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of~     patients after total knee replacement surgery which is treated with epidural analgesia or~     peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of~     postoperative opiate consumption.~   "
158637|NCT01489618|"~     The main objective of this study is to evaluate and to compare the specific antibody response~     to a  prime-boost  vaccine strategy combining the seven valence pneumococcal conjugate~     vaccine (PnCj) prime at W0 followed by the administration of the pneumococcal capsular~     polysaccharide vaccine (PPS) boost at W4, to the administration of the pneumococcal capsular~     polysaccharide vaccine (PPS) alone at W4 in patients with common variable immunodeficiency.~   "
158638|NCT01489605|"~     Patients presenting for elective surgery requiring orotracheal intubation will be randomized~     to being intubated with either the GlideScope Groove video-laryngoscope or the standard~     GlideScope video-laryngoscope.~   "
158639|NCT01489592|"~     The purpose of this study is to determine the impact of curcumin, administrated orally, on~     iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin~     expression that the investigators observed in vitro and serum hepcidin levels.~   "
158640|NCT01489579|"~     The purpose of this study is to determine whether giving more structured information to~     patients over the phone about quitting tobacco helps to increase the chance that they will~     try to quit. The results of this study will help provide direction in developing a more~     standard way of helping patients to quit.~      Study Hypothesis:~      Brief, structured, telephone tobacco cessation counseling delivered by clinical pharmacy~     specialists will significantly increase the percentage of self-reported tobacco cessation~     attempts compared to usual care among patients enrolled in a cardiovascular risk reduction~     program.~   "
158641|NCT01489566|"~     This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial.~     Patients with no tumor lesions one month after resection of hepatocellular carcinoma will be~     randomized in a 1:1 ratio to 1 of the 2 treatment groups：6mg/d Tyroserleutide (injection), or~     placebo.~      The objective is to evaluate the effect of Injectable Tyroserleutide on the recurrence-free~     survival,overall survival,quality of life,and the safety and tolerability of subjects after~     the resection of hepatocellular carcinoma~   "
158642|NCT01489553|"~     For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management~     includes identification of the causative food and avoidance. Egg allergy is among the most~     common causes of IgE-mediated food allergy in children, affecting approximately 1.6% of~     children (its prevalence is higher in children with atopic dermatitis or other food~     allergies). Given the prevalence of egg and the difficulty to avoid it in the diet, we aim to~     investigate the safety and efficacy of baked egg oral immunotherapy.~   "
158643|NCT01489540|"~     Accurate early burn depth assessment is important to determine the optimal treatment. The~     most applied method to asses burn depth is clinical assessment. This method is the least~     expensive, but not very accurate. Laser Doppler imaging (LDI) has been shown to accurately~     assess burn depth. The clinical effects, the costs and cost-effectiveness of this device~     however, are unknown. The hypothesis is that an eary accurate diagnosis will lead to an~     earlier therapeutic decision: surgery or no surgery. Earlier excision and grafting probably~     leads to a decrease in wound healing time, in length of hospital stay and in costs.~      Before the investigators decide to implement LDI in Dutch burn care a study of the clinical~     effects and cost-effectiveness of LDI is necessary. Therefore a multicenter randomized~     controlled trial will be conducted, including all patients with burns of indeterminate depth~     (burns that are not obviously superficial or full thickness) treated in the Dutch burn~     centres. In total 200 patients will be included in an 18 months period. The patients are~     randomly divided in two groups: 'new diagnostic strategy' versus 'current diagnostic~     strategy'. Burn depth will be diagnosed both by clinical assessment and laser Doppler imaging~     in all patients. The results of the LDI-scan will be provided to the treating clinician in~     the 'new diagnostic strategy' group only. Time to wound healing, diagnostic and therapeutic~     decisions, and costs are observed.~   "
158644|NCT01489527|"~     Moffitt Cancer Center is the Coordinating Center for this study.~      The purpose of this study is to develop and test the infrastructure to conduct a future Phase~     III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus~     (HPV) genotype distribution, data needed to design a Phase III trial. The investigators~     propose to conduct a Preparedness study among women ages 16-24 years of age residing in a~     region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence.~      The specific aims of this study are to:~        1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm,~          400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18~          [Gardasil]) or placebo vaccine.~        2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical~          lesion prevalence among young females ages 16-24 years at high risk for HIV infection.~        3. Assess the rate of compliance through the 3-dose vaccination series~   "
158645|NCT01489514|"~     This is a proof of concept study to determine the safety and allergenicity of hypoallergenic~     peanut product extract as compared to standard peanut extract in an adult population with~     known peanut allergy. This will be assessed by epicutaneous skin prick testing. The~     hypothesis is that subjects with previously diagnosed peanut allergy will have less~     epicutaneous reactions to the hypoallergenic peanut product extract.~   "
158646|NCT01489501|"~     This clinical study is a scientific study on patients who do not have any limbal stem cells.~     In this clinical study tissue is taken from the inside of the mouth, and cells from that~     tissue (epithelial cells) will be grown to form a multilayered cell-sheet, called CAOMECS,~     which is then transplanted onto the cornea. This transplantation method should repair the~     damage of the cornea.~      The aim of this study is to see if the transplantation of CAOMECS renews the surface of the~     eye, by preventing the growth of the conjunctiva over the cornea and stopping new small blood~     vessels forming.~   "
158647|NCT01489488|"~     Primary objective: To determine oral bioavailability of the liquid formulation intended for~     pediatric use and potential food effects in healthy adults.~      Secondary objective: To evaluate safety and tolerability measured by physical examination~     findings, vital signs, electrocardiogram (ECG), laboratory parameters, and adverse events~     (AEs).~   "
158648|NCT01489475|"~     During cardiopulmonary bypass (CPB) after heart surgery, a child's blood is exposed to many~     foreign entities. These conditions trigger the body's inflammatory response which results in~     leaky capillaries, increased swelling and possibly organ dysfunction. Since the early 1990's,~     modified ultrafiltration (MUF) has been shown to decrease excess swelling, reduce bleeding,~     improve heart function, and decrease hospital length of stay. Angiopoietins are a family of~     proteins necessary for both normal and abnormal blood vessel formation. They also appear to~     play a role in capillary leak. Though MUF has been shown to improve clinical outcome~     following CPB, there continues to be conflicting reports whether this is a result of the~     filtration of inflammatory proteins or simply from excess fluid removal. Since angiopoietins~     appear to play a role in both inflammation and capillary leak, the investigators hypothesize~     that the benefit seen after MUF is also secondary to its ability to filter out these~     proteins, especially angiopoietin-2.~   "
158649|NCT01489462|"~     The primary purpose of this study is to compare the effects of a high and low intensity~     strength training programs vs. a control group on knee pain and compressive joint forces.~   "
158650|NCT01489449|"~     The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R)~     Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.~   "
158651|NCT01489436|"~     New minimally invasive surgical treatments are often outpatient procedures with low~     complication rates, promising fast recovery. The traditional physician-reported outcomes such~     as complication rates, blood loss, and hospital stay are not useful to guide treatment~     recommendations for one or the other minimally invasive procedure. This study aims to apply~     patient-reported outcomes developed within the NIH framework for cancer research and chronic~     disease treatment to the comparative effectiveness research in minimally invasive procedures~     for benign disease.~   "
158652|NCT01489423|"~     RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with~     ipilimumab with or without sargramostim may help doctors learn more about the effects of~     ipilimumab and sargramostim on cells. It may also help doctors understand how well patients~     respond to treatment.~      PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III~     melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.~   "
158653|NCT01489410|"~     Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used~     method for the palliative or curative treatment of these lesions. These attempts are being~     made to make these patients a better candidate for liver transplant or to provide palliation~     for their condition.~   "
158654|NCT01489397|"~     Magnified intelligence chromoendoscopy (FICE) plus probe-based confocal laser endomicroscopy~     (pCLE) for Gastric Intestinal Metaplasia (GIM) diagnosis: a feasibility trial~      Research Question:~      Is confocal endomicroscope feasible to diagnose gastric intestinal metaplasia?~      Objective:~      To evaluate the feasibility of confocal endomicroscope in diagnose gastric intestinal~     metaplasia.~      Hypothesis:~      Confocal endomicreosocpe can provide the accurate diagnosis of gastric intestinal metaplasia.~      Research design:~      Diagnostic study~      Sample size:~      The investigators follow the population in recent study from Imraporn et al.: Validity of~     magnify NBI for gastric intestinal metaplasia targeted biopsy (N= 50)~      Data analysis:~      Confocal Barrett's esophagus classification was used to evaluate agreement of confocal~     endomicroscopic finding in gastric intestinal metaplasia. The accuracy of new criteria for~     GIM by confocal endomicroscope was evaluated in relation to pathological report, a gold~     standard for diagnosis, and reported as sensitivity, specificity, positive predictive value,~     negative predictive value and accuracy of these criteria.~      Expected Benefit and Application:~      The feasibility of confocal endomicroscopy for diagnosis gastric intestinal metaplasia in~     order to improve the quality of GIM/dysplasia/early gastric cancer detection and then~     decrease the mortality rate from gastric cancer in the future.~   "
158655|NCT01489384|"~     The purpose of this study is to investigate the safety and efficacy of Cimzia given as an~     add-on to your current therapy with disease-modifying anti-rheumatic drug(s)~     (DMARDs)including MTX or given as monotherapy (alone) over an 18 month period.~      Approximately 125 patients with moderate to severe Rheumatoid Arthritis (RA) who are being~     prescribed Cimzia will be enrolled into the study.~   "
158656|NCT01489371|"~     This phase I trial studies the side effects and the best dose of giving EGEN-001 together~     with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian~     epithelial, fallopian tube, or primary peritoneal cancer that has returned after a period of~     improvement or has not responded to treatment. Biological therapies, such as EGEN-001, may~     stimulate the immune system in different ways and stop tumor cells from growing. Drugs used~     in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving EGEN-001 together with pegylated liposomal doxorubicin hydrochloride may~     kill more tumor cells.~   "
158951|NCT01485536|"~     The goal of this clinical research study is to learn if AUY922 can help to control refractory~     or recurrent lymphoma. The safety of AUY922 will also be studied.~      AUY922 is designed to block tumor growth by blocking a protein.~   "
158657|NCT01489358|"~     Background:~      - Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache,~     muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint~     pain, which may be directly related to the infecting virus, may be severe and last for~     several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new~     experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy~     adults. Participants cannot develop CHIKV from this vaccine.~      Objectives:~      - To test the safety and effectiveness of a Chikungunya virus vaccine.~      Eligibility:~      - Healthy individuals between 18 and 50 years of age.~      Design:~        -  This study, including vaccine doses and followup tests, will last about 44 weeks.~          Participants will have three vaccination visits, six followup clinic visits, and three~          telephone contacts during this study. Vaccination visits will take about 4 hours. Most~          other clinic visits will usually take 2 hours. The telephone contacts will take about 15~          minutes.~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will also be collected.~        -  Participants will be assigned to one of three dose groups. Information about doses will~          be provided before the start of the vaccinations.~        -  Vaccine injections will be given at the start of the study, at 4 weeks, and at 20 weeks.~          Participants will be asked to keep an eye on the injection site for 7 days and to notify~          researchers if there are any side effects.~        -  Participants will be monitored throughout the study with blood samples and clinic~          visits.~   "
158658|NCT01489345|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-2952~     across ascending multiple doses in healthy adult male and female subjects. The secondary~     objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.~   "
158659|NCT01489332|"~     The use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is~     standard treatment of locally advanced rectal cancer. It has reduced local recurrence rate to~     less than 10%, but has only had limited effect on overall survival due to the constantly high~     (more than 30%) rate of distant metastasis.~      Complete eradication of the primary tumour observed in the histopathological specimen~     (pathological complete response, pCR) correlates with a favourable overall prognosis so~     obtaining a pCR might be beneficial. The aim of the study is to investigate whether the~     addition of capecitabine based chemotherapy before preoperative chemoradiation and also~     before the operation improves pathological complete remission rate in locally advanced rectal~     cancer with acceptable toxicity. Secondary objectives are to evaluate pathological~     downstaging rate, histopathological R0 resection rate,sphincter preservation rate,~     perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality~     of life.~   "
158660|NCT01489319|"~     The purpose of this study is to determine the relationship between lipid-induced inflammation~     and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS); and to examine~     the effect of salsalate and polygonum cuspidatum extract (PCE) containing resveratrol on~     lipid-induced inflammation, ovarian androgen secretion, body composition and ovulation in a~     subset of normal weight women with PCOS.~   "
158661|NCT01489306|"~     The purpose of the study is to assess the tolerability and safety of a range of repeated~     inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and~     determination of blood levels of MDT-637 following inhalation.~   "
158662|NCT01489293|"~     The purpose of this study is to analyze the expression and activity of inhibitory molecules~     on eosinophils obtained from allergic subjects.~   "
158663|NCT01489280|"~     In this study, the body temperatures of men and women undergoing elective surgery will be~     measured using the Temple Touch Pro. In the operating room, each patient's temperature will~     be measured with both the Temple Touch Pro and another one or two of the continuous reference~     methods used clinically for measuring the core temperature.~      The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a~     receiving unit. The former is attached to the skin, while the latter is placed near the~     patient or the vital signs monitor and receives data from the patch. The core temperature~     equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by~     conductive sensors that perform skin temperature measurements and then applies a special~     algorithm in order to calculate the body's temperature.~   "
158664|NCT01489267|"~     Hereditary cerebellar ataxia is a type of autosomal dominant genetic disease, lesions mainly~     involving the cerebellum, but the spinal cord and cranial nerves may also be some~     involvement. A total of 20 molecularly diagnosed SCA1 patients divided in two groups. One~     group accepted for the treatment of stem cell transplantation,the other group will be the~     control. Purpose of this project to prove that allogeneic umbilical cord mesenchymal stem~     cells are applied to clinical safely, and in the treatment of hereditary cerebellar ataxia is~     valid.~   "
158665|NCT01489254|"~     The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer~     acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple~     sclerosis~   "
158666|NCT01489241|"~     The purpose of this study is to evaluate whether the introduction of a short-term~     telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged~     from the hospital after disease exacerbation produces benefits in terms of a reduction in~     hospital readmissions and health related quality of life. In addition the trials evaluate the~     economical and organisational impact of the services and examine their acceptability by~     patients and health professionals.~   "
158667|NCT01489228|"~     This study will assess the safety and efficacy of E1224, a pro-drug of ravuconazole, in~     individuals with chronic indeterminate Chagas disease recruited in research centres in Tarija~     and Cochabamba, Bolivia.~   "
158668|NCT01489215|"~     This study will inform the field about underlying mechanisms associated with infant sleep~     problems and will deepen the understanding of the intervention process. The study will~     provide detailed information on the intervention process itself and will explore how~     behavioral sleep interventions affect broader infant outcome.~   "
158669|NCT01489202|"~     Percutaneous coronary intervention (PCI) with stenting may induce endothelial~     damage/dysfunction and inflammatory reactions, which in turn delay healing and~     endothelialization and may lead to restenosis and atherosclerosis within the stented~     segments. Drugs and polymers are considered the protagonists of these pathophysiologic~     processes whereas the role of stent platforms remains poorly defined.It remains unknown,~     conversely, if stent platforms affect the extent of post-PCI endothelial damage and~     inflammation.~   "
158670|NCT01489189|"~     The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in~     eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial~     growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are~     non-inferior to those in eyes that receive standard prompt PRP therapy.~      Secondary objectives include:~        -  Comparing other visual function outcomes (including Humphrey visual field testing and~          study participant self-reports of visual function) in eyes receiving anti-VEGF with~          deferred PRP with those in eyes receiving prompt PRP.~        -  Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of~          prompt PRP.~        -  Comparing safety outcomes between treatment groups.~        -  Comparing associated treatment and follow-up exam costs between treatment groups.~   "
158671|NCT01489176|"~     The purpose if this study is to examine how effective Regadenoson is in detecting coronary~     artery disease during a stress echocardiogram when Optison is administered. Optison is a~     contrast agent that improves the images of the heart on the echocardiogram (echo) machine.~     Optison is approved by the Food and Drug Administration (FDA) to use during stress~     echocardiograms. Regadenoson is a commercially available rapid acting stress agent that is~     used to chemically increase the heart rate and is approved for nuclear imaging tests.~     Regadenoson is a FDA approved drug but not for the intended use in this study.~   "
158672|NCT01489163|"~     The purpose of this research study is to implement and evaluate a lifestyle program designed~     to help women who have high glucose levels during pregnancy make healthful diet and physical~     activity changes to lose weight. Eligible women will be randomly assigned to life-style~     intervention or usual medical care.~   "
158673|NCT01489150|"~     In patients treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory~     failure, the interest of using the End-tidal Co2 measurement device Capnostream to evaluate~     PaCo2 and PaCo2 variations over time will be evaluated. Measurements will be done under~     normal expiration and under prolonged active and passive expiration maneuvers.~   "
158674|NCT01489137|"~     The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic~     changes to head fixation in the patients undergoing neurosurgery.~   "
158675|NCT01489124|"~     This is prospective, randomized and crossover design to assess the pharmacokinetic and~     pharmacodynamics of three regimen.~        -  0.5-hr infusion of imipenem 0.5 g every 6 hrs~        -  2-hr infusion of imipenem 0.5 g every 6 hrs~        -  2-hr infusion of imipenem 1 g every 6 hrs~      Clinical and laboratory data such as Age,Sex, Body weight, CBC, Electrolyte, Vital signs,~     APACHE II score, BUN, Cr, Sample and Blood culture will be collected.~      Nine patients will be enrolled in this study. After completion of the imipenem therapy for 3~     days in this study, all patients will receive other sensitive antibiotics to eradicate their~     bacterial infections.~      Blood samples (approximately 3 ml) will be obtained by direct venepuncture at the following~     time: 0, 0.5, 1, 2, 3, 4, 5 and 6 after 4th dose of imipenem.~      Concentration of imipenem in plasma will be measured by HPLC method. Then, the data will be~     simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and~     reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).~   "
158676|NCT01489111|"~     This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect~     of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.~   "
158677|NCT01489098|"~     The purpose of this study is to determine if toddlers and children who were fed breast milk~     or infant formulas at different levels of protein between 3 and 12 months of age have~     differences in growth and body composition at 3 and 5 years of age.~   "
158678|NCT01489085|"~     Rational: Intellivent is a ventilation mode completely automated which controls ventilation~     and oxygenation parameters. Safety and performance of IntelliVent has still been demonstrated~     in post operative heart surgery for patient with a controlled ventilation on short period (2~     to 4 hours). This feasibility study evaluate the use of Intellivent for Intensive care unit~     patients from intubation to coming off.~      Primary objective : Compare parameters which have been selected by automated mod~     (Intellivent) to those selected by clinical practitioner in a conventional mode~      Secondary objectives: Record oxygenation , gaseous interchange and ventilation parameters.~     Record complications, number of manual adjustments and prognostic signs.~      Methodology: Patients in the intensive care unit who need invasive ventilation. They will be~     included after a detailed information (information note). Oxygenation and ventilation~     parameters will be recorded 2 times by day from intubation to coming off. The investigator in~     charge will determine daily at the bedside of the patient the adjustments he should make in a~     conventional mode. These adjustments will be compared to the IntelliVent automated~     adjustments.~      Experimental study, observational, prospective, comparative, opened, monocentric in an~     intensive care unit.~      Number of patients: 100~   "
158679|NCT01489072|"~     This study is designed to compare the effects of two bolus doses of intravenous remifentanil~     given prior to the emergence of anesthesia:~        -  on the incidence of perioperative coughing~        -  on the time needed for the emergence of a desflurane-based anesthesia~        -  on the incidence of sore throat after extubation.~      The investigators hypothesis is that the use of a higher remifentanil bolus dose (0.5 mcg/kg)~     given prior to emergence of a desflurane-based anesthesia will reduce the incidence of~     perioperative coughing when compared to a lower dose of remifentanil (0.25 mcg/kg).~   "
158680|NCT01489059|"~     The purpose of this study is to determine whether the combination of interleukin-21 (IL-21)~     and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the~     clinical benefits of the combination compared with Ipilimumab alone~   "
158681|NCT01489046|"~     The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well~     tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for~     treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects~   "
158682|NCT01489033|"~     Based on EMA (European Medicines Agency) new guidelines on the clinical development of~     products for immunotherapy for the treatment of allergic disease the aim of this study was to~     assess safety and tolerability of three different subcutaneous immunotherapy dose escalations~     in patients allergic to the pollen of Phleum pratense.~   "
158964|NCT01485367|"~     This is an open label 6 month pilot study for male and female participants over the age of 52~     that desire treatment and prevention of senile purpura of the forearms.~      This study will be evaluating the effects of Adapalene 0.3% for the use in the treatment and~     prevention of senile purpura.~   "
158683|NCT01489020|"~     Based on EMA (European Medicines Agency) new guidelines on the clinical development of~     products for immunotherapy for the treatment of allergic diseases the aim of this study was~     to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations~     in patients allergic to Dermatophagoides pteronyssinus.~   "
158684|NCT01489007|"~     Few areas are more controversial in pediatric nutrition than the role of a vegetarian diet~     for children. Advocates make strong health claims whereas others have expressed safety~     concerns, especially regarding iron nutrition. The frequency of vegetarianism among children~     is said to be rapidly increasing although clear data are not available. Surveys of children~     in the US age 8 to 18 reported in the media find that about 3-5% of children are lacto-ovo~     vegetarian, with some fish or chicken products in the diet. This is a substantial proportion~     that is very likely to increase over the next few years with essentially no nutrient~     metabolism data related to this population.~      One of the principal concerns with a lacto-ovo vegetarian diet, as preferred by many~     children, is the lack of heme iron in the diet. A key question that can be evaluated in~     children is whether iron status is in fact affected by a lacto-ovo vegetarian diet.~      According to the American Academy of Pediatrics (AAP Pediatric Nutrition Handbook, 6th~     Edition, 2008), vegetarian diets can provide appropriate nutrition for children. Depending on~     the level of dietary restriction, fortified foods or supplements may be necessary during~     different life stages. In addition, strict vegetarian children may have slightly higher~     protein needs compared to non-vegetarian children due to decreased protein digestibility in~     certain plants. The AAP further recommends that children 4-8 years old consume a minimum of~     five servings per day of beans/nuts/seeds/eggs and six servings per day of calcium-rich~     foods.~      To evaluate this issue, the investigators will use a stable isotope method to directly assess~     iron status. It is increasingly recognized that the ability to absorb iron when given with~     vitamin C is a highly accurate measurement of iron status and may be a true gold standard in~     this regard. In this planned study, investigators will be able to assess both reference dose~     iron absorption and standard biochemical markers of iron status in a group of lacto-ovo~     vegetarians and compare them with age- and gender-matched children on a non-vegetarian diet.~     These data can be important in determining if iron status is decreased in lacto-ovo~     vegetarians and will serve as a basis for future interventions and evaluations if a~     difference is found.~   "
158685|NCT01488994|"~     The purpose of this study is to assess BAX 326 pharmacokinetic parameters, to evaluate its~     hemostatic efficacy, safety, immunogenicity, and changes in health-related quality of life in~     pediatric patients.~   "
158686|NCT01488981|"~     This study will evaluate the feasibility of using fully implanted microstimulators to~     rehabilitate arm function in patients who have suffered a traumatic brain injury.~   "
158687|NCT01488968|"~     Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver~     higher biological doses to targets in order to improve tumor control and with acceptable~     rectal toxicity compared to conventional fractionation.~   "
158688|NCT01488955|"~     In this study, patients with uncomplicated urinary infection are investigated. It is~     investigated if treatment of only symptoms of the uncomplicated urinary infection is as~     effective as treatment with antibiotics with respect to the outcome of the urinary infection.~     If this is the case, the use of antibiotics in the treatment of uncomplicated urinary~     infections might be reduced.~      Secondary aim of the study is the safety evaluation of both treatment strategies with respect~     to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.~   "
158689|NCT01488942|"~     In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV~     infection among users of illicit drugs. Among drug users who present to care and start highly~     active antiretroviral therapy (HAART), retention in care and adherence to their treatment~     regimen may be less than optimal. Given the known benefits of HAART on both the individual~     and populational levels, new strategies are required to help retain HIV-infected drug users~     on HAART.~      Contingency management (CM) is a strategy to affect behaviour by providing a reward (e.g.~     money) to reinforce the desired behaviour. CM has been used with success in other areas of~     medicine (e.g. smoking cessation, weight loss) and in the drug using population, but has not~     been established as a means to improve retention in HAART programs.~      The proposed research primarily seeks to assess the effectiveness of monetary-based CM in~     retaining HIV-infected drug users in HAART programs. 240 HAART-eligible subjects will be~     randomized in a 2:1 ratio to either receive (n=160) the reinforcer or to a control arm~     (n=80). All subjects will receive HAART and standard care, and those randomized to the~     reinforcer arm will receive escalating reinforcement initially for attendance at each clinic~     visit (until month 6 after starting HAART) and subsequently (until month 12 after starting~     HAART) will receive an escalating variable reinforcer for each month in which a plasma viral~     load less than or equal to 100 copies/mL is maintained.~      Our hypotheses are that drug users initiating HAART and randomly selected to receive a~     reinforcer for attending clinic visits then maintaining monthly virologic suppression during~     the first 52 weeks after HAART initiation will be significantly more likely to achieve~     virologic suppression at 52 weeks, will have a significantly longer duration of sustained~     virologic suppression during the first 52 weeks, and will be significantly more likely to~     maintain virologic suppression at 72 weeks after HAART initiation, than those not offered a~     reinforcer.~   "
158690|NCT01488929|"~     Negative symptoms and cognitive dysfunction in schizophrenia (CDS) are core features of~     schizophrenia. These negative symptoms and cognitive deficits have a devastating impact on~     the function, employment, and social interactions of patients with schizophrenia. Medications~     used to treat schizophrenia (e.g. atypical antipsychotics) do not improve negative symptoms~     or CDS. TC-5619 is being developed for use as an add-on therapy in combination with atypical~     antipsychotics to treat patients with negative symptoms and CDS.~   "
158691|NCT01488916|"~     Vitamin D deficiency is associated with an unfavorable metabolic profile in several~     observational studies. However, the influences of vitamin D concentrations on postprandial~     glucose in type 2 diabetes (DM) are less studied. The purposes of the study are to study the~     effects of vitamin D inadequacy on postprandial glucose excursion and metabolic responses in~     patients with type 2 DM. This is a cross-sectional study. About 150-180 patients will be~     screened for serum levels of 25(OH)D. A total of 45 eligible patients will be grouped into~     three groups by different vitamin D status: vitamin D deficiency, vitamin D insufficiency,~     and the controls. The patients will receive a mixed meal test for postprandial glucose~     excursion and metabolic responses. The investigators will use statistical methods to assess~     the differences in post-challenge glucose and metabolic response among the three groups of~     patients. The investigators hope the study can explore the relationship between vitamin D and~     glucose excursion in patients with type 2 DM.~   "
158692|NCT01488903|"~     Not many studies examined genetic determinants of obesity in women. As pre-menopausal and~     post-menopausal women appear to have different propensities for fat deposition, genetic loci~     linked with obesity-related phenotypes might be different by menopausal status. So far, there~     is no large scale of genetic study deciphering common obesity focusing on women population to~     examine the contributions of aging and change in menopausal status to obesity in Taiwan. The~     investigators propose this study to compare phenotypic profiles of obesity and~     cardio-metabolic factors in pre-menopausal and post-menopausal women. The study will examine~     the contributions of aging and change in menopausal status to the changes of obesity-related~     traits during the transition from pre-menopause to post-menopause period, and will evaluate~     the contribution of genetic susceptibility on body fat deposition among women at different~     stage of menopause.~   "
158965|NCT01485354|"~     The purpose of this study is to assess the clinical outcomes of upper extremity training~     using the Armeo Spring system in a chronic post-stroke population with impaired upper~     extremity function.~   "
158693|NCT01488890|"~     The aim of this study is to evaluate the administration of CYD dengue vaccine following a~     compressed schedule in different populations.~      Primary Objectives:~        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes~          at baseline and 28 days after CYD dengue vaccine Dose 3 in defined study groups.~        -  To describe the persistence of the humoral immune response to each of the 4 parental~          dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in defined study groups.~      Secondary Objective:~        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes~          at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in defined study~          groups, irrespective of whether or not Yellow fever (YF) vaccine has been previously~          administered.~        -  To describe the YF humoral immune response at baseline and 1, 3, and 7 months after~          injection of the YF vaccine at Month 0 in Groups 3 and 4.~        -  To describe the safety profile in terms of solicited injection site and systemic events,~          unsolicited adverse events and serious adverse events after each injection of CYD dengue~          vaccine and/or YF vaccine.~   "
158694|NCT01488877|"~     PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary~     purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and~     pharmacodynamics of multiple doses of PF-03882845 in this population.~   "
158695|NCT01488864|"~     The objectives of this study are to compare frequency and severity of moderate to severe~     vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an~     untreated control-group (CG) and to investigate if Health Related Quality of Life improve in~     the AR-group compared to an untreated CG.To study if salivary cortisol excretion would change~     within the AR treated group compared with the control group.~   "
158696|NCT01488851|"~     Prospective observational multi central cohort study to assess the incidence of osteo~     necrosis of jaw in cancer patient with bone metastasis starting Zoledronic acid treatment~   "
158697|NCT01488838|"~     A Randomized Phase II study of Adjuvant Concurrent Radiation and Chemotherapy versus~     Radiation alone in Resected High-Risk Malignant Salivary Gland Tumors~   "
158698|NCT01488825|"~     The present study was designed to evaluate effect of yoga intervention on patients having~     frequent tension type headache.~   "
158699|NCT01488812|"~     This study investigates the relationship between waiting time to surgery and the risk for~     medical complications and 1-year mortality in hip-fracture patients.~   "
158700|NCT01488799|"~     The current study examines whether change-readiness, and consequently treatment outcome, can~     be enhanced in Cognitive Behavioral Therapy (CBT) for severe Generalized Anxiety Disorder~     (GAD) by adding a brief course of Motivational Interviewing (MI adapted for anxiety, Westra &~     Dozois, 2003) before and during CBT when motivation wanes. 106 individuals with severe GAD~     will be randomly assigned to receive an equal number of sessions of either MI and CBT (MI-CBT~     arm) or CBT alone (CBT alone arm). It is expected that the MI-CBT arm relative to the CBT~     alone arm will show lower levels of resistance in CBT, higher levels of homework compliance~     and therapeutic alliance, better moment-to-moment interpersonal process, and consequently~     superior outcomes - both post-treatment and at 6 and 12 month follow-ups.~   "
158701|NCT01488786|"~     The purpose of this study is to assess the safety of the BrainPort vision device and to~     demonstrate improved object recognition and word identification and ambulation with use of~     the BrainPort vision device in subjects who are medically documented as blind, with acuity of~     20/ 5000 or worse.~   "
158702|NCT01488773|"~     The objective of the study was to compare in real life clinical practice two treatment~     regimens: inhaled glucocorticosteroid + salmeterol and inhaled glucocorticosteroid +~     montelukast.~   "
158703|NCT01488760|"~     The purpose of this study was to evaluate feed-forward contraction of the transversus~     abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus~     externus during calm and standardized respiration in low back pain patients and pain-free~     subjects.~   "
158704|NCT01488747|"~     The primary objective of this investigation is to determine the relative percentage and rate~     of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3~     (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements~     versus an encapsulated triglyceride in defined plasma lipid pools.~      The primary endpoints to be evaluated include the fatty acid composition of plasma lipids~     before and after consumption of a single dose of emulsified triglyceride based fish oil and~     triglyceride of similar n-3 compositions in capsule form. The investigators will measure~     changes in plasma phospholipid, and chylomicron fatty acids.~   "
158705|NCT01488734|"~     The purpose of this study is to compare the safety and efficacy of two different amounts of~     vitamin D2 (600 or 4000 International Units/day) provided by mushrooms added to one of the~     daily meals versus same doses of vitamin D3 provided as oral supplements sold in any~     drugstore in reaching adequate or optimal blood levels of 25(OH)D in people with Vitamin D~     deficiency and pre-diabetes (high blood sugar without full blown diabetes) or the metabolic~     syndrome. Metabolic syndrome is the name of a group of risk factors that raise the risk for~     heart disease and other health problems, such as diabetes and stroke as described by the US~     department of Health and Human Services.~      This study will also attempt to demonstrate and compare the effect of the intervention with~     above two doses of vitamin D on blood levels of tests that show inflammation.~   "
158706|NCT01488721|"~     The purpose of this study is to assess the agreement of clinical performance between the~     proposed NeoPlex 4 assay and NeoPlex System and the comparator devices in clinical use in~     newborn screening programs for detection of T4, TSH, 17-OHP and IRT.~   "
158707|NCT01488708|"~     The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399~     in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).~   "
158708|NCT01488695|"~     A new GlideScope videolaryngoscope has been developed, which utilizes a track on the superior~     surface of the blade to guide the endotracheal tube, which is advanced in the track as~     opposed to free-hand along the inferior surface, where the camera is located. This new~     GlideScope can be used for double-lumen endotracheal tubes (DLT). The investigators~     hypothesize that this GlideScope will be easier to use than the Macintosh blade.~   "
159524|NCT01478061|"~     The Study plan is a post-market prospective, multi-center, open-label registry. The vein~     graft failure rates for the currently commercialized C-Port devices will be compared to an a~     priori rate taken from the peer-reviewed literature.~   "
158709|NCT01488682|"~     Recently, the HS has been used in head and neck surgery as an alternative to conventional~     hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have~     been published on the evidence of its safety in ND, especially in radical ND. Researchers~     investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND),~     while using conventional hand-tied ligation to a minimum, in terms of operating time, blood~     loss, drainage and complications.~   "
158710|NCT01488669|"~     In this study we introduce and evaluate the feasibility of our surgical technique to hide the~     external scar of neck dissection using the robotic system via a modified facelift or~     retroauricular approach.~   "
158711|NCT01488656|"~     This study will determine if a comprehensive antioxidant/anti-inflammatory dietary supplement~     pack can offer protection against a decline in lung function and increase in inflammation and~     oxidative stress following acute exposure to particulate matter air pollution with a diameter~     <2.5 µm (PM2.5).~      The investigators hypothesis is a follows: Compared to an appropriate control,~     supplementation with a comprehensive antioxidant/anti-inflammatory dietary supplement pack~     for 18 weeks will: 1) reduce the decline in lung function following acute exposure to~     naturally occurring elevations in PM2.5 levels as measured by exhaled nitric oxide levels and~     forced vital lung capacity; and 2) reduce changes in pro-inflammatory cytokines following~     acute exposure to naturally occurring elevations in PM2.5 levels as measured by plasma levels~     of C-reactive protein.~   "
158712|NCT01488643|"~     There is increased frequency of asthma in obese patients. This study is trying to find out if~     there is a difference in the presence of bronchospasm during anesthesia in obese and non~     obese patients.~   "
158713|NCT01488630|"~     The lack of substance screening and referral in healthcare settings is a significant problem~     with far-reaching consequences, including excess morbidity, premature mortality, and inflated~     healthcare costs. An easy to use, time-efficient referral system is needed to address this~     problem. The Substance Treatment Referral Systems (STaRS), a computer assisted screening and~     referral system, was developed to meet this need.~      STaRS Phase I demonstrated the feasibility of STaRS to meet this need. All aims and~     evaluation goals of the Phase I study were met or exceeded. The purpose of the Phase II~     research is to demonstrate the clinical utility and commercial viability of STaRS.~      Specific Aims of Phase II are:~        1. Integrate STaRS with the Epic electronic health record used in the Cooper Health System~          in Camden, N.J.~        2. Document STaRS' effectiveness in (a) increasing the number of referrals provided for~          substance abuse treatment and HIV screening, and (b) increasing the proportion of~          patients that initiate specialty treatment.~        3. Evaluate clinician acceptance and impact upon revenue generation.~      The research will be conducted at Cooper Family Medicine (CFM) department of Cooper~     University Hospital in New Jersey. We will determine the rate of referrals and treatment~     initiation for 3,500 adult patients treated during treatment as usual (the time before STaRS~     is implemented at CFM) as well as 3,500 adult patients treated after the introduction of~     STaRS. Patients will be asked about the referral initiation process, and CFM healthcare~     providers will be asked to evaluate the system from a clinical and administrative~     prospective. Finally, billing records will be reviewed during the STaRS implementation to~     determine whether STaRS impacted revenue for the practices.~   "
158714|NCT01488617|"~     The purpose of this study is to determine whether psychological and social factors in~     addition to medical (physiological) conditions may contribute significantly to the prediction~     of the postoperative outcome.~      Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and~     (2) alteration of quality of life.~   "
158715|NCT01488604|"~     This study will test 200 people to see if an experimental nasal spray has an effect on~     symptoms of the common cold if used when the symptoms start. At the first visit to the~     clinic, potential subjects will have tests to make sure they qualify to participate in the~     study.~      If they qualify, they will have an equal chance of receiving the experimental nasal spray or~     a sham nasal spray (one that does not have the experimental formula). At the first visit,~     subjects will receive their assigned nasal spray and use it once at the clinic. They will~     also receive a booklet called a diary. Subjects will take the rest of their treatments for~     day 1 at home, and for the next six days, they will use the nasal spray four times per day~     and record their symptoms in the diary, as instructed. Then subjects will come back to the~     clinic for a final visit.~   "
158716|NCT01488591|"~     The aim of this study :~        1. Through the study of genes of protein, transporter, translator and epigenome~          investigating the effect of anti-cancer treatment or the key factor of the MDR~          (Multidrug resistance) on the blood cancer patients who are under the anti-cancer sork~          treatment~        2. Giving a service of anticancer medicine therapeutic drug monitoring (TDM) and genotyping~   "
158717|NCT01488578|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of~     adverse drug reactions in this surveillance, and 3) factors considered to affect the safety~     and/or efficacy of this drug.~   "
158726|NCT01488461|"~     Congenital ataxias (CA) are rare, non progressive diseases, characterized by psychomotor~     retardation, hypotonia followed by ataxia. The presence of the molar tooth on MRI allowed~     to define Joubert syndrome, a peculiar form of CA. Apart from this group, CA are mostly~     associated with cerebellar atrophy or hypoplasia without molar tooth on MRI. CA are a~     clinically as well as genetically heterogeneous group of diseases. Early-onset ataxias are~     progressive but may be difficult to distinguish from CA in the first years of the disease. To~     date, few genes responsible for CA have been identified: ABC7 (X-linked CA associated with~     sideroblastic anemia), SLC9A6 (X-linked CA associated with severe mental retardation, autism~     and epilepsy), GPR56 (CA associated with polymicrogyria), ATCAY (pure CA in Cayman isolate);~     the involvement of the ATCAY and ABC7 genes has never been assessed in a large cohort of CA~     patients.~      Primary objective:~      To assess the frequency of mutations of the ATCAY and ABC7 genes in patients affected with~     non Joubert congenital or early-onset ataxia.~      Secondary objective:~      To identify new loci and/or genes responsible for CA To further describe the clinical~     phenotype of the CA and to assess the frequency of the various clinical types (pure CA/CA~     associated with spasticity/ syndromic CA, congenital/early-onset CA, sporadic/familial CA).~      To describe the clinical phenotype of CA related to mutations in one of analysed genes.~   "
158718|NCT01488565|"~     Myelodysplastic Syndrome (MDS) is a disease of the bone marrow characterized by~     anemia,neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet~     counts). MDS patients with thrombocytopenia who fail standard therapies require regular~     platelet transfusions which are expensive and inconvenient, and are a risk for further~     serious bleeding complications. The new treatment of MDS using azacitidine has shown to~     increase the survival rate of MDS patients including to improve platelet production over~     time. However,in the early cycles of treatment with azacitidine,the low platelet counts tend~     to exacerbate before they provide any clinical benefit.~      Eltrombopag is a drug designed to activate the thrombopoietin receptor. Eltrombopag has been~     able to increase platelet counts in healthy Thrombocytopenia Purpura (ITP), a disease where~     patients destroy their own platelets very rapidly and thus develop thrombocytopenia.~      Eltrombopag is administered orally and is Therapeutic Goods Administration (TGA) approved for~     the treatment of thrombocytopenia in patients with chronic ITP who failed to respond to~     standard treatment.~      This study is a single arm pilot study to evaluate the safety and tolerability of Eltrombopag~     in the treatment of low platelet counts in adult subjects with MDS treated using azacitidine~     This study also incorporates a correlative laboratory component designed to determined the~     mechanism of action of 5-azacitidine +/- Eltrombopag and to determine a baseline profile~     which may predict those most responsive. These studies will incorporate gene methylation and~     expression, and immunoprofiling.~   "
158719|NCT01488552|"~     The Investigators in the PCRT team have developed a therapeutic regimen which attacks both~     the tumor compartment and the stromal compartment of pancreatic cancer and induces complete~     responses in a small percentage of patients with advanced stage IV pancreatic cancer.~   "
158720|NCT01488539|"~     Researchers hope to learn whether a flexibly applied cognitive behavioral treatment for~     Post-Traumatic Stress Disorder (PTSD) is more effective than the psychotherapy usually~     provided in the clinic (called Treatment as Usual or TAU). Primary Hypothesis: STAIR/NT will~     be superior to TAU in improving PTSD symptoms at 28, 36 and 48 weeks post-randomization~   "
158721|NCT01488526|"~     Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains~     a concern and has been reported in approximately 8-15% of infants born to hepatitis B e~     antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10~     copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior~     observational studies have shown that antiviral therapy including lamivudine or telbivudine~     use during late pregnancy can safely reduce the rate of vertical transmission in this special~     population compared to untreated patients.~      Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes~     serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse~     effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this~     study:~        1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10~          copies/mL (or > 200,000 IU/mL) during late pregnancy and infants.~        2. Its efficacy in the reduction of HBV vertical transmission rate.~   "
158722|NCT01488513|"~     This phase I trial studies the side effects and best dose of ABC294640 in treating patients~     with advanced solid tumors. ABC294640 may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Please note that the FDA OOPD is participating as a~     funding source.~   "
158723|NCT01488500|"~     Air pollution is linked to respiratory and cardiovascular disease. Wood smoke is a common air~     in many parts of the world and previous studies indicate that wood smoke induce oxidative~     stress in the respiratory tract. It is not determined how different types of biomass~     combustion affect human health. In this study the investigators plan to investigate how~     inhalation of wood smoke and pellets smoke affect respiratory and cardiovascular health.~   "
158724|NCT01488487|"~     The purpose of this study is to estimate the time to disease progression when everolimus and~     pasireotide are given together in patients with advanced or metastatic HCC who have not had~     any prior systemic therapy.~   "
158725|NCT01488474|"~     The prevalence of diabetes mellitus (DM) in industrialized countries is estimated to be about~     7.3% and its incidence has been growing in recent years. The prevalence of diabetic~     neuropathy in the diabetic patient population is up to 50%. When limb surgery is necessary,~     it is reasonable to assume that diabetic patients will benefit from a peripheral regional~     anesthesia because of the severe comorbidities associated with DM. On the other hand, the use~     of regional anesthesia (RA) has generally not been recommended in patients with preexisting~     neuropathies mainly because of medical liability issues, as worsening neuropathy could be~     attributed to nerve damage caused by the regional anesthetic. The current state of the art of~     peripheral regional anesthesia for the identification of correct placement of an injection~     needle suitably close to the target nerve is to elicit a motor response by current injection~     through the needle. Constant reduction of the current as the nerve is approached ensures~     close proximity so that an effective nerve block is obtained when the local anesthetic is~     delivered through the needle, and absence of a motor response at 0.3 mA is generally accepted~     as a safety marker to avoid harmful intraneural injection. An important deficit in our~     understanding is whether diabetic neuropathy influences the stimulation parameters for~     peripheral nerve stimulation (PNS), possibly decreasing safety.~      The currently proposed research is guided by the hypothesis that nerves in patients with DM~     are more resistant to stimulation and the current thresholds for PNS have to be set much~     higher to prevent injections from occurring within the epineurium. The investigators will~     examine the effect of DM on nerve excitability in a blinded, prospective, observational case~     control trial. Accordingly, the investigators have defined following aims:~      Specific Aim 1: To characterize the required stimulation current in patients with and without~     diabetes mellitus.~      Specific Aim 2: Follow-up to examine if the rate of adverse neurologic events is higher in~     diabetic patients.~      Specific Aim 3: Guided by the results, formulate recommendations for the performance of~     regional anesthesia in patients with a history of DM.~      These experiments will provide better understanding of the needle-current-nerve relationship~     during peripheral nerve stimulation. Findings from this study will have a major impact on~     patient safety, especially in the subgroup with preexisting neuropathy, undergoing regional~     anesthesia.~   "
158727|NCT01488448|"~     The purpose of this study is to determine if nebulized hypertonic saline (or extra salty~     water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad~     chest colds) get better enough to be discharged from the hospital sooner than those infants~     given nebulized normal saline (or regular salty water mist).~   "
158728|NCT01488435|"~     The purpose is to determine if the consumption of study product has an effect on acute~     respiratory infections and/or diarrheal disease.~   "
158729|NCT01488422|"~     This study will identify neural mechanisms associated with changes in emotion regulation~     following participation in stress reduction programs.~   "
158767|NCT01487928|"~     Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies~     show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly~     affect an infant's growth. The investigators now have the ability to measure caloric density~     of human milk and add human milk cream to any human milk (mother's own or donor human milk)~     that is less than 20 kcal/oz to bring it up to that amount.~   "
158730|NCT01488409|"~     The purpose of the study is to examine whether a medication called acipimox can improve your~     body's mitochondria. Mitochondria are the power house of the cell and make energy for your~     body.~      Obesity is associated with increased risk for developing diabetes. However, the investigators~     do not know how obesity leads to diabetes. Previous studies have shown levels of fat in the~     blood (free fatty acids or FFA) are higher in obesity, and elevated FFA can affect how our~     body uses glucose and responds to insulin. Recent studies have shown that changes in~     mitochondria may be involved in the development of diabetes and may be affected by FFA. The~     investigators propose to improve the function of mitochondria in obese people with~     pre-diabetes by treating with acipimox, a medication which decreases FFA. The investigators~     will use state of the art techniques to evaluate the mitochondria, including a new magnetic~     resonance imaging (MRI) technique to measure function of mitochondria in muscle.~   "
158731|NCT01488396|"~     The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic~     emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by~     subjective symptoms and signs.~   "
158732|NCT01488383|"~     A natural sweetener (Stevia Rebaudina Bertoni) reduces blood glucose levels and blood~     pressure according to various preclinical and clinical studies conducted worldwide. Since it~     is not found many studies in the literature wich compares Stevia Rebaudiana with saccharin,~     we've proposed a randomized crossover clinical trial comparing the effects on postprandial~     capillary blood glucose and blood pressure in healthy adults.~      Sample: healthy professionals from two health centers in Alava (Kakuabizkarra primary care~     center and Txagorritxu hospital). Inclusion criteria: Professionals of two health centers of~     Álava (Lakuabizkarra and Txagorritxu) and active employment status at the beginning of the~     trial, weighing more than 50kg and age over 18 years.~      Intervention: 200mg capsules of Stevia or 250mgcapsules of saccharin. Measurements: Capillary~     blood glucose and blood pressure, fasting and after eating. Evaluation of satiety, hunger and~     fullness by questionnaire after intake, and at the end of the day.~      Statistical analysis: Compare the postprandial capillary glucose levels between 8 am and 1 st~     hour, 2nd hour 3rd hour after intake between treatments by ANCOVA. We will also compare blood~     pressure before and after intake between treatments. We will also compare by t test or paired~     Wilcoxom (depending on the nature of the variable) the results of the questionnaire after~     intake between treatments.~   "
158733|NCT01488370|"~     This is a prospective randomized clinical study to be performed in pediatric patients under~     the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation.~     Time to endotracheal intubation will be compared between patients intubated using a~     GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and~     those intubated by standard direct laryngoscopy. The study hypothesis is that the time to~     endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when~     compared to the GlideScope® video laryngoscope group and standard laryngoscopy.~   "
158734|NCT01488357|"~     Deciding whether or not to have breast reconstruction after mastectomy is highly challenging~     for many patients. This study will examine patients' decisions about reconstruction and the~     effects of reconstruction on quality of life and body image.~   "
158735|NCT01488344|"~     RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid~     leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of~     BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells.~      PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose~     cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works~     in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II).~   "
158736|NCT01488331|"~     This prospective, multi-center, observational study will assess the progression-free survival~     and safety of patients with locally advanced or metastatic non-small cell lung cancer treated~     with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be~     collected for 24 months.~   "
158737|NCT01488318|"~     This is a single-arm, non-masked, open-label, Phase II study of cetuximab + dasatinib in~     recurrent Squamous Cell Carcinoma of The Head and Neck (SCCHN) that has recurred after~     cetuximab-containing therapy (please see attached schema).~      The primary endpoint 12-week PFS.~   "
158738|NCT01488305|"~     Helen Keller International (HKI), the ministry of health and population, and ministry of~     agriculture and cooperatives, of Nepal and local non-governmental organizations (NGO)~     partners are currently implementing a USAID funded Action Against Malnutrition Through~     Agriculture (AAMA) project in Baitadi district located in far Western development region of~     Nepal. HKI is undertaking this study within the AAMA project to test whether providing~     micro-nutrient powders (MNPs) in a programmatic context along with homestead food production~     (HFP) and an intensive community level Infant and Young Child Feeding Behavior change~     communication (IYCF-BCC) intervention will have a greater impact on reducing anemia and~     improving growth in young children than only providing the HFP and IYCF-BCC intervention~     without MNPs or a control with no intervention.~   "
158739|NCT01488292|"~     This study evaluates the efficacy of the RECAP Mental Health + Academic Program for special~     education students in behavioral classrooms. The program includes multiple service~     components: the RECAP classroom mental health curriculum, which develops students' behavioral~     and social skills; reading intervention; individualized skills training; and parent group.~     Schools are randomly assigned to the treatment or control group. This two-year~     multi-component mental health and academic intervention is hypothesized to improve students'~     mental health, social skills, and academic functioning.~   "
158740|NCT01488279|"~     The investigators hypothesize that sitagliptin will significantly reduce impairments in~     insulin secretion and insulin resistance resulting from short-term oral glucocorticoid~     therapy.~   "
158741|NCT01488266|"~     The objective of this study is to compare the efficacy and safety of aripiprazole as~     adjunctive therapy versus switching to different class of antidepressants for treating major~     depressive disorder partially or minimally responsive to ongoing antidepressant treatment.~   "
158764|NCT01487967|"~     This pilot intervention study will test the feasibility and acceptability and explore the~     outcomes of an urban, primary care-based intervention to measure families' preferences and~     goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical~     care to reach these goals.~   "
158742|NCT01488253|"~     Study Design: To evaluate the efficacy of the combination of sirolimus and tacrolimus as a~     graft-versus-host disease prophylaxis, the investigators are going to perform a phase II,~     multicenter clinical trial after human leukocyte antigen (HLA)-matched, related peripheral~     blood stem cell transplants (PBSCT) in patients with hematologic malignancies. Total 116~     patients will be accrued.~      Objective: The primary objective is to evaluate the rates of 100 day Grade II-IV acute GVHD.~     Secondary objectives include the time to neutrophil and platelet engraftment, the incidence~     of grade III-IV acute GVHD, non-relapse mortality during 100 days after transplant, mucositis~     severity, all infectious complications including cytomegalovirus (CMV) reactivation, vascular~     complications (venoocclusive disease of liver; VOD, thrombotic microangiopathy; TMA),~     disease-free survival, and overall survival at 1 year after transplant.~      Eligibility Criteria: Eligible patients are between 20 and 60 years of age, have acute~     leukemia, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and adequate~     organ function. For available sibling donor, a serologic (or higher resolution) 6/6 Class I~     HLA-A and B and molecular Class II DRB1 must be matched.~      Treatment Description: Conditioning regimens will vary by center and donor will donate~     peripheral blood stem cells according to local institutional practices. Peripheral blood stem~     cells will not be manipulated or T-depleted prior to infusion. Tacrolimus will be~     administered at 0.05 mg/kg/day intravenously by continuous infusion beginning on day -1 with~     a target serum concentration of 5 to 10 ng/mL. Sirolimus will be administered as a 6 mg oral~     loading dose on day -1, followed by a 3 mg/day single dose, with a target serum concentration~     of 3 to 12 ng/mL. Levels will be monitored weekly during hospitalization and then as~     clinically indicated. Intravenous tacrolimus will be converted to an oral equivalent dose~     prior to discharge and both immunosuppressives will be tapered beginning at day +100 after~     transplantation and eliminated by day +180 when clinically feasible.~      Accrual Period: The estimated accrual period is three years. Patients will be followed for~     100 days post transplantation for evaluation of the primary endpoint, with additional~     follow-up to two years after transplantation for evaluation of secondary endpoints.~   "
158743|NCT01488240|"~     The purpose of this study is to determine the effects (good or bad) of pulsed dye laser~     treatment in burn scar height, texture, redness and pliability in acute burn injury.~   "
158744|NCT01488227|"~     Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce~     injuries and illnesses, and improve performance in collegiate swimmers and divers.~      Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course~     of the intervention period.~   "
158745|NCT01488214|"~     Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This~     disease is usually thought to spare central nervous system. However, neuropsychiatric~     manifestations like depression and cognitive functions impairment seem to be frequent.~     Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter~     hyperintensities have been reported suggested CNS vascular manifestations in systemic~     sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric~     manifestations in systemic sclerosis is unknown. The primary objective of this prospective~     and multicentre study is to assess a link between neuropsychiatric manifestations and CNS~     involvement in systemic sclerosis. Secondary objectives are to assess the frequency of~     neuropsychiatric manifestations, to compare central nervous system abnormality between~     scleroderma patient and healthy subjects. Central nervous system involvement and~     neuropsychiatric manifestations will be systematically assessed through central nervous~     system imaging and questionnaires.~   "
158746|NCT01488201|"~     This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate~     safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous~     administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.~   "
158747|NCT01488188|"~     Background: It is well established that live attenuated organisms can be highly effective~     vaccines, immune responses elicited can often be of greater magnitude and of longer duration~     than those produced by non-living antigens and are often able to confer protection after a~     single dose. Unlike killed influenza vaccine preparations injected by the parenteral route,~     live influenza vaccines are able to induce potent secretory (mainly IgA) antibody responses~     in the airway mucosae and can also evoke cell mediated responses. T cell proliferation,~     cytokine production, cytotoxic T cell responses and antibody-dependent cell cytotoxicity have~     all been elicited by live attenuated vaccines.~      There has been a history of the use of live attenuated flu vaccines as safe and effective~     vaccines for the prevention of flu in animals and humans. Live-attenuated cold-adapted~     influenza vaccines have been proved to be highly efficacious to protect against clinical fly~     symptoms. Among these, FluMist, a nasal vaccine formulation developed by Medimmune Inc, has~     been approved by the US FDA. Recent side by side clinical trials have demonstrated that this~     nasal vaccine was significantly superior to conventional killed flu vaccine in protecting~     against flu symptoms.~      Sublingual administration of live influenza virus at a dose lethal by the nasal route was~     well tolerated and did not redirect virus to the olfactory bulb. In addition, in a recent~     Phase I clinical study (NCT00820144) conducted in France, the sublingual administration of~     recombinant cholera toxin B subunit (rCTB,up to 1 mg) in healthy adult volunteers was found~     to be safe.~      A major issue has arisen regarding the ease with which vaccines could be administered to~     young children, especially infants, and to elderly subjects in whom nasal vaccination has not~     been possible and/or approved due to difficulties of administering nasal vaccines in infants~     and to undesired side effects related to frequent rhinitis and sneezing episodes in elderly~     subjects. This study is designed to investigate the safety, tolerability and immunogenicity~     of a new route of administration of vaccines, using the nasal FluMist formulation as~     prototype vaccine.~      Objectives: To evaluate the immunogenicity and safety of a nasal and sublingual influenza~     virus vaccine (FluMist) in healthy adult volunteers~      Study design: This will be a randomized study on a total 40 subjects; each 20 subjects will~     receive vaccine via nasal and sublingual route, respectively~   "
158748|NCT01488175|"~     The purpose of this study is to investigate if the use of a tourniquet during insertion of a~     cemented primary total knee arthroplasty will influence clinical and radiological (measured~     with RSA X-ray technique) outcome.~   "
158749|NCT01488162|"~     This multi-center, prospective, observational study will describe the management of relapsing~     or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2~     years.~   "
158750|NCT01488149|"~     Intrapartum epidural analgesia has been associated with adverse breastfeeding outcomes. One~     potential mechanism involves transfer of epidural fentanyl across the placenta and neonatal~     blood-brain barrier, where it can subsequently attenuate neonatal exhibition of feeding~     behaviors, such as latching and swallowing, during the immediate postpartum period. Vigorous~     feeding behavior during the first days of life is a significant predictor of long-term~     breastfeeding success at 3 and 6 months. In a randomized, controlled, double-blinded study,~     neonatal Neurologic and Adaptive Capacity Scores (NACS) were significantly lower when mothers~     received >150 mcg epidural fentanyl versus bupivacaine-only analgesia, and mean umbilical~     cord fentanyl concentration was significantly higher in the >150 mcg versus <150 mcg group.~      The investigators hypothesize that epidural fentanyl-bupivacaine analgesia is significantly~     associated with decreased breastfeeding rates at hospital discharge and with neonatal~     deficits in latching onto the breast and swallowing during the first three hours of life, and~     that a significant dose-response relationship exists with respect to total micrograms~     fentanyl infused.~      The investigators will perform a prospective cohort study of all parturients age 18+ at UHCMC~     over a three-month period, excluding those with multiples gestation, Cesarean section, or~     neonatal intensive care unit admission. From patient charts, the investigators will record~     the following variables: number of neonates delivered; type of delivery (spontaneous vaginal~     / operative vaginal / Cesarean section); whether the neonate was admitted to the intensive~     care unit; the mother's age, height, weight, gravity, parity, intention to breast-feed at the~     time of hospital admission, number of children previously breast-fed, and ethnicity;~     gestational age at the time of delivery; administration of oxytocin for labor augmentation~     and in what quantity; duration of active labor; antibiotic administration; neonatal APGAR~     scores at 1 and 5 minutes postpartum; and whether opioids or antibiotics were administered~     before and/or after the delivery and at what exact time. We will also record whether each~     patient received an epidural during labor and, if so, the duration of this epidural infusion~     and the total micrograms fentanyl delivered; neonatal feeding behavior as quantified by the~     LATCH scores assigned to each breast-feeding interaction that occurs on the postpartum care~     floor; whether the mother is breast-feeding her baby at the time of discharge from the~     hospital, and if not, then her primary reason for not doing so (as communicated during the~     standard postpartum lactation consultation); and how long mother and baby stayed in the~     hospital post-delivery.~   "
158751|NCT01488136|"~     The investigators know that intensive insulin therapy and tight glucose control is associated~     with reduction of diabetic complications. However, many patients on insulin don't achieve~     this because of the risk and the fear of hypoglycaemia (too low blood glucose).~      There has been a lot of work done recently looking at the mechanisms by which the brain~     detects hypoglycaemia. A key player is a potassium channel in the brain (KATP channel).~     Studies have shown that when these channels are opened, there is a release of hormones such~     as adrenaline that can help in raising blood sugars to counteract and increase awareness of~     hypoglycaemia. The investigators study aims to look at an old drug called diazoxide, which is~     able to open KATP channels.~      The investigators aim to see if diazoxide will amplify the release of hormones such as~     adrenaline when the blood sugar is low. If this is the case, this will aid quicker recovery~     following hypoglycaemia.~      The investigators aim to do this by performing a well established experimental protocol that~     has been performed safely over the last 20 years called a clamp study. The clamp study will~     involve slowly bringing the blood sugars down using insulin and intravenous glucose in a~     controlled fashion. The main outcome will be the hormonal responses (adrenaline response) at~     a blood sugar level of 2.5mmol/L. Symptoms of hypoglycaemia will be monitored, as well as~     working memory tests using standardised questionnaires.~      The design of the investigators study will be a randomised trial comparing the effects of~     diazoxide with placebo in which all patients will receive both diazoxide and placebo in~     random order (crossover design).~   "
158752|NCT01488123|"~     The purpose of this study is to determine whether a four-month manualized Ayurvedic~     intervention will improve quality of life in recent breast cancer survivors.~   "
158753|NCT01488110|"~     The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of~     migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks,~     and presence of a preventive effect two months post treatment. Another purpose is to~     investigate if and how this treatment affects manifestations of the autonomic nervous system~     activity.~   "
158754|NCT01488097|"~     This is an extension study to the first clinical study of SBC-102 (sebelipase alfa) for the~     treatment of LAL Deficiency. It is an open label study in adult patients with liver~     dysfunction due to Lysosomal Acid Lipase (LAL) Deficiency. This study will assess the~     long-term safety, tolerability, and efficacy of SBC-102. The targeted number for this study~     is 9 evaluable subjects.~   "
158755|NCT01488084|"~     The purpose of this study is to compare saphenous veins harvested using the atraumatic~     pedicled (no-touch) technique to saphenous veins harvested using the conventional open~     technique in patients undergoing isolated coronary artery bypass surgery. Investigators will~     compare the biological structure of the saphenous veins harvested using these two techniques.~     There is some evidence that saphenous veins harvested using the no-touch technique may~     allow for better patency up to 8 years following bypass surgery. We may be able to detect~     early differences in vascular structure, observed at the time of conduit harvest.~   "
158756|NCT01488071|"~     The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is~     at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms~     that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.~   "
158757|NCT01488058|"~     Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in~     the maintenance of disorders. One specific bias is the interpretation of ambiguous~     information. A negative interpretation bias is defined as a systematic tendency to interpret~     potentially ambiguous information in a negative rather than benign way and this bias has been~     associated with symptoms of depression. Research has led to the recent development of~     computerized cognitive bias modification (CBM) techniques to augment such biases and it has~     been suggested that CBM techniques may be useful as an adjunct to current treatments to~     enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM~     procedures lend themselves to being delivered remotely, are cost-effective, and can be~     self-paced in ways that suit the patient make them an ideal candidate for inclusion in the~     Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St.~     Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the~     current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to~     the existing iCBT modules offered through St. Vincent's Hospital and the University of New~     South Wales. It is expected that iCBT + CBM will result in superior treatment outcomes as~     indexed by a standardized clinical battery.~   "
158758|NCT01488045|"~     The study aim is to determine if Propofol or the combination of Fentanyl and low-dose~     Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a~     colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study~     is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the~     participant, and the secondary outcome will be the discomfort of the patient and difficulty~     of the procedure as perceived by the physician.~   "
158759|NCT01488032|"~     The purpose of the study is to prove if there is any difference in the nerve fiber layer~     between patients with normal- and high-tension-glaucoma with similar structural optic nerve~     head parameters.~   "
158760|NCT01488019|"~     This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term~     safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary~     Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of~     double-blind treatment.~   "
158761|NCT01488006|"~     This prospective study will evaluate the Bigliani/Flatow prosthesis. The aims of this study~     are to establish the safety, effectiveness, and value of the prosthetic system, and to~     collect information from expert shoulder surgeons as to features of the implants,~     instruments, and techniques which may be further improved. In this study, the investigators~     hypothesize that this prosthetic device will significantly improve long-term patient-based~     outcomes, functional status and quality of life.~   "
158762|NCT01487993|"~     The purpose of this study is to determine whether metformin is effective in reducing BMI and~     insulin resistance in obese children and adolescents.~   "
158763|NCT01487980|"~     Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min~     after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron~     status until six months after birth, without increasing the risk of polycythaemia or other~     adverse events. We hypothesize that this intervention will also benefit low birth weight~     infants in South Africa.~   "
158768|NCT01487915|"~     Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma.~      But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice.~      Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb)~     with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred~     regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities.~      But the grade 3 or worse toxicities associated with GCb are not infrequent and need more~     effective and more tolerable regimens.~      GemOx has been reported to be effective and have very favorable toxicity profiles.~   "
158769|NCT01487902|"~     The purpose of this study is to assess the androgen deprivation therapy when patients with~     castration-resistant prostate cancer are treated with docetaxel-based chemotherapy.~   "
158770|NCT01487889|"~     Primary objective of this study is to examine the effects of 2 different approaches of~     dietary strategies to optimise fatty acid composition in complementary food on infant's fatty~     acid status and its consequences on cognitive and visual development.~      Subjects are randomly assigned to one of three groups:~        -  Rapeseed oil (high in n-3 PUFA and small n-6:n-3 ratio to support endogenous n- 3~          LC-PUFA metabolism)~        -  Fatty fish (preformed n-3 LC-PUFA, especially DHA)~        -  Corn oil (as control group, high in n-6 PUFA, common in complementary food).~      The intervention starts with the beginning of complementary feeding as generally recommended~     between 4 to 6 months of age and ends at the age of 10 months. For this period of time~     subjects of all groups receive commercial vegetable-potato-meat-meals as part of~     complementary food which only differs in the fatty acid composition.~   "
158771|NCT01487876|"~     In order to study the immunotherapeutic effects of electroporation (EP)-mediated~     dual-plasmids Hepatitis B Virus DNA vaccine, the investigators plan to conduct a~     double-blind, randomized, placebo-controlled trial, approved by Chinese State Food and Drug~     Administration with written informed consent from each chronic hepatitis B (CHB) patients~     with baseline ALT more than 2 times the ULN, for whom antiviral treatment is indicated and~     who were under the simultaneous lamivudine (LAM) chemotherapy.~   "
158772|NCT01487863|"~     The purpose of this study was to evaluate the impact of concurrent versus sequential~     administration of abiraterone acetate plus prednisone on the ability to manufacture~     sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and~     efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate~     plus prednisone in men with metastatic castrate resistant prostate cancer.~   "
158773|NCT01487850|"~     On the basis of 2 cases of immunologically-induced lung disease in 2 saxophonists, the~     investigators supposed that wind reed instruments could be contaminated with molds. The~     investigators led a study on 40 musicians playing a wind reed instrument to analyze~     instruments' fungal contamination and its immunological and clinical consequences for~     musicians.~   "
158774|NCT01487837|"~     The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger~     levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the~     treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study~     hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF <~     13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after~     start of surgery as compared to a trigger level of ROTEM FibTEM MCF < 8 mm.~   "
158775|NCT01487824|"~     The purpose of this study is to investigate whether early life exposures such as premature~     birth or exposure to preeclampsia before you are born results in long-term alterations in the~     cardiovascular system that increase risk of cardiovascular disease development.~   "
158776|NCT01487811|"~     This trial is conducted in the United states of America (USA). The aim of this trial is to~     compare two formulations of biphasic insulin aspart 30 in healthy volunteers.~   "
158777|NCT01487798|"~     This trial is conducted in Europe. The aim of this trial is to investigate the difference in~     frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30~     compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.~   "
158778|NCT01487785|"~     This phase Ib study includes two phases: dose escalation phase and safety expansion phase.~      During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and~     maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225~     administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase~     of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for~     expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or~     metastatic pancreatic adenocarcinoma patients.~      During the safety expansion phase, once the MTD of LDE225 is established, additional patients~     will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to~     further evaluate its safety, tolerability and explore the potential efficacy of the combined~     treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.~   "
158779|NCT01487772|"~     The aims of the studies are to examine the impact of delayed time to surgery for hip-fracture~     patients with regard to in-hospital complication rate and one-year mortality and to evaluate~     two different fast-track systems for hip-fracture patients with regard to patient outcome,~     complication rate and patient satisfaction.~   "
158780|NCT01487759|"~     The purpose of this study is to investigate the influence of the prebiotic oligofructose~     enriched inulin on the metabolite pattern in Crohn's disease patients.~   "
158781|NCT01487746|"~     The investigators expect to find higher levels of both classical and minor antiphospholipid~     (APL) antibodies among the stroke cases. Furthermore, the investigators expect to find not~     only classical APLA but also minor antibodies.~      The investigators believe that minor antibodies have a major role in the hypercoagulability~     state.~   "
158782|NCT01487733|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.~   "
158803|NCT01487460|"~     This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in~     healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311~     concentration in blood and effect of TAP311 administration on simvastatin concentration will~     also be assessed in healthy volunteers.~   "
158783|NCT01487720|"~     Prostate cancer is one of the most common malignancies affecting men all over the World.~     Metastatic prostate cancer responds to androgen deprivation for a variable period (20-25~     months). Prostate cancer that grows despite castrate levels of testosterone and that no~     longer responds to any form of hormonal manipulation is defined as castrate resistant~     prostate cancer (CRPC).~      Docetaxel combined with prednisolone has been shown to not only improve QOL and PSA response~     in CRPC, but also extend the overall survival1. However, the efficacy of the drug has not~     been universally effective, and nearly all patients have disease progression after docetaxel~     treatment.~      After failure of a docetaxel regimen, With the exception of cabazitaxel or abiraterone, which~     are not widely and easily availabe in Korea, little treatment regimen can be applied to the~     patients with reasonable response and benefits.~      Gemcitabine is a nucleoside analog with activity against a broad spectrum of solid tumors.~     When gemcitabine is used as first-line therapy for CRPC, disease control rate was 33% with~     median duration of 7.1 months. When it is combined with prednisone and zoledronic acid in~     pretreated patients with CRPC, the PSA response rate was 23% with a disease control rate of~     57% in patients with measurable disease.~      Oxaliplatin is newer platinum agent that has favorable toxicity profile and evidence of~     activity in cisplatin-resistant cell lines. Droz et al. performed a multicenter phase II~     study in 54 patients with metastatic CRPC who were randomized to receive oxaliplatin either~     alone or with 5-FU. More than 50% of the patients had received prior chemotherapy including~     cisplatin. Despite heavy pretreatment, PSA desclines were noted in 11% and 19% of patients in~     each arm.~      Gemcitabine plus oxaliplatin combination was widely studied and has been reported to be safe~     and effective in various cancers.~      This study is to assess the efficacy and safety of GEMOX in docetaxel-refractory CRPC.~   "
158784|NCT01487707|"~     The objective of this cluster randomized controlled trial is to assess the impact of several~     community-based interventions that address the key factors underlying the high maternal~     mortality, as well as neonatal mortality and morbidity in northern Nigeria. The~     interventions, include:~        1. a Voluntary Health Worker Program (VHW)~        2. the VHW program with provision of a safe birth kit~        3. the VHW program with community folk media activities.~   "
158785|NCT01487694|"~     Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat~     menopausal symptoms. To date, there are still scarce information about its efficacy in Thai~     women with menopausal symptoms. The purpose of this study will assess the efficacy of black~     cohosh extract in management of menopausal symptoms in Thai women.~   "
158786|NCT01487681|"~     Human papilloma virus (HPV) infection contributes as a main causative factor to the~     development of invasive cervical cancer (ICC) and its precursors (cervical intraepithelial~     neoplasia, CIN). Currently, two prophylactic vaccines are employed for the prevention of~     genital HPV infection. As the prophylactic efficacy is type-restricted, determining the~     type-specific HPV distribution and their associations with ICC and its precursors would~     provide essential information in assessment of HPV vaccination program impact. The baseline~     information is also important for monitoring possible changes in type-specific HPV~     distribution after vaccination has been introduced.~      Prevalence of HPV infection varies considerably across the world, and data were limited from~     less-developed countries. Knowledge of the detail pattern of HPV type-specific distribution~     in each region will be essential for public health policy decisions. This will also form the~     basis for determining which types should be included in future generation HPV vaccines~     targeted to specific regions.~      While most studies were focus on ICC and high-grade cervical lesions, the association between~     HPV types and the progression of CIN1 has rarely been studied. CIN1 is an insensitive~     histopathological sign of HPV infection, most of which will spontaneously regress to normal~     with host immune system. However, some genotypes have been described as being more persistent~     and associated with progression from low-grade lesions to high-grade lesions, even ICC.~     Geographical data on type-specific prevalence of HPV in CIN1 with appropriately designed~     prospective studies would be helpful in identifying types preferentially associated with~     progression to malignancy and accurately predicting the future impact of vaccination in~     specific regions.~      Free vaccination supported by the government appears to be unlikely at present in China.~     Thus, individuals need to pay the cost of vaccines for themselves presently. Yangtze River~     Delta Area is the most economically developed regions in China, and people here may become~     the largest vaccinated population at their own expense in China. To the best of the~     investigators knowledge, no multi-center study on HPV type-specific distribution and their~     associations with ICC and its precursors is available in Yangtze River Delta Area, China,~     which highlights the need for timely study in this region before large scale vaccination~     programs are carried out.~   "
158787|NCT01487668|"~     Persons with serious mental illness (SMI) are at increased risk of cardiovascular disease~     (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to help~     promote health behavior change and improve mental health and physical health-related quality~     of life, as well as to get feedback from patients and providers on what is needed to help~     better coordinate the physical and mental health care of these patients.~   "
158788|NCT01487655|"~     Color Doppler Imaging (CDI) has been providing information about ocular blood flow over the~     past decades. This non-invasive procedure based on ultrasound technique has identified~     increased resistance and decreased systolic blood velocities to exist in the ophthalmic~     arteries of glaucoma patients. However, existing data has provided very little information~     regarding the analysis of the Doppler waveform in itself and to whether variables such as~     early systolic acceleration or systolic/diastolic velocity ratios are of any significance in~     glaucoma disease. In other medical specialties using CDI technology, such as nephrology or~     cardiology for instance, this analysis has been part of the normal routine. This information~     has been used in screening patients for disturbed circulation such as arterial stenosis or~     providing information regarding prognosis of renal and hepatic transplants have been used for~     decades now.~      What is the normal characteristics of the waveform Doppler analysis? To answer this, the~     investigators will create a normative database using healthy controls.~      Are there signs of altered stiffness or compliance in the ophthalmic arteries of glaucoma~     patients? To answer this, the analysis of early acceleration acceleration and detection of an~     early peak systolic will be done on the Doppler curves of glaucoma patients and compared to~     the healthy normative database.~      Are there any difference between the two types of glaucoma [primary open-angle glaucoma~     (POAG) and normal-tension glaucoma (NTG)]? The investigators will compare the variables of~     the ophthalmic artery waveform in these two groups.~      Do any of these Doppler waveform variables have any clinical significance? To answer this,~     the investigators will search for the existence of any correlation between the waveform data~     and both functional (visual field testing) and structural (Confocal scanning laser~     ophthalmoscopy - CSLO) variables of the glaucoma groups.~   "
158789|NCT01487642|"~     The primary objective of the study is to compare the efficacy of four different smoking~     cessation programmes, including a proactive telephone counseling intervention, a reactive~     telephone counseling a and an interactive web-based intervention and (as control) written~     self-help material.~   "
158790|NCT01487629|"~     The purpose of this study is to compare the morphological and visual acuity outcomes~     associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for~     treatment of diabetic macular edema.~   "
158791|NCT01487616|"~     Aims: We plan to investigate how common uterine malformations are in high-risk women (with~     history of miscarriage or preterm delivery), by analysing different characteristics in these~     groups. This study will also investigate other ultrasound characteristics detected on these~     women. This study will point towards the possible mechanism of how uterine malformations may~     affect pregnancy outcomes.~   "
158804|NCT01487447|"~     The purpose of this study is to determine the efficacy of a customized sound therapy in~     reducing tinnitus loudness and increasing the residual inhibition.~   "
158805|NCT01487434|"~     In partnership with the Chicago Public Schools (CPS), the goal of this project is to test the~     effectiveness of a manualized mentoring and case management program for students in grades~     1-8. Most of the current policy and research attention on dropout has focused on the dropout~     decision itself, even though dropout is more likely to be simply the end point of a~     longer-term developmental process. This project seeks to learn more about the relative~     effectiveness of preventing dropout through mentoring and case management programs, and to~     learn more about the relative effectiveness of intervening early vs. later.~   "
158792|NCT01487603|"~     Lung cancer is the leading cause of death in the world. Overall 5-year survival rate is fewer~     than 10% and the effectiveness of conventional chemotherapy is limited. The new knowledge~     shows the correlation between genetic alteration and effective of chemotherapy. Therefore~     non-surgical modalities to obtain tumor specimens for genetic alteration analysis are~     particularly critical in lung cancer, since many patients have advanced disease at the time~     of first presentation, and are therefore not eligible for radical surgery. Endobronchial~     ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) samples obtained during~     diagnosis of lung cancer can be used for molecular analysis that will predict response to~     treatment and prognosis. In this study, we will detect specific target molecules related to~     the effectiveness of treatment (surgery, chemotherapy, radiotherapy) and prognosis in~     patients with lung cancer using EBUS-TBNA samples and its combined with xenograft technology.~   "
158793|NCT01487590|"~     For breech presentation, the cesarean section rate is decreased by external cephalic version.~     This is a painful operation, with some rare but serious complications. The aim of this trial~     is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to~     correct breech presentation before 37 weeks of gestation.~   "
158794|NCT01487577|"~     Bone marrow transplantation (BMT) is used to successfully treat high-risk forms of leukemia,~     lymphoma, and other childhood cancers that were once considered incurable. A major barrier to~     the application of this life-saving treatment is acute graft-versus-host disease (GVHD) which~     develops in approximately 30-80% of patients and is a leading cause of death from transplant~     complications. Current GVHD prevention methods are not very efficacious and lead to~     unacceptable side effects. Mycophenolate mofetil (MMF), an anti-rejection medication used in~     solid organ transplants, has shown great promise in BMT recipients. The effectiveness of MMF~     depends on blood levels of mycophenolic acid (MPA, the active form of MMF). Different~     patients have been found to have different blood levels of MPA when they are given the same~     dose of MMF. The purpose of this study is to study a novel method of giving MMF based on its~     metabolism (pharmacokinetics) to achieve desired blood levels of MPA for prevention of GVHD.~     Non-invasive ways of monitoring the drug exposure will also be studied. The ultimate goal of~     this study is to improve approaches to GVHD prevention and improve outcomes of BMT in~     children.~   "
158795|NCT01487564|"~     The purpose of this study is to investigate the pharmacokinetics of OROS hydromorphone in~     healthy adult Taiwanese participants after the oral administration of a single 16 mg dose.~   "
158796|NCT01487551|"~     The primary objective is to study changes in disease related biomarkers in patients with~     progressive SSc during treatment with ABR-215757.~      The secondary objectives are to assess the safety and tolerability of ABR-215757,to assess~     disease activity and quality of life (QoL)during treatment with ABR-215757 and to assess the~     plasma levels of ABR-215757 during the study.~   "
158797|NCT01487538|"~     The purpose of this study is to compare an technology-based weight maintenance intervention~     using action plans, videos discussion boards and health behavior tracking (weight, calories~     in and out, pedometer steps) with a technology-based standard advice group to facilitate~     health management, resourcefulness and health status for rural middle-aged women.~   "
158798|NCT01487525|"~     The purpose of this research study is to determine whether low intensity resistance training~     with concurrent application of a peripheral blood flow restriction device to the exercising~     limb will elicit increased quadriceps strength, functional gains, ability to complete~     knee-related activities of daily living, mobility, and quality of life in individuals at risk~     for developing symptomatic knee osteoarthritis (OA). It is known that higher quadriceps~     strength is protective against developing symptomatic knee OA.1 However, people at risk for~     knee OA frequently do not tolerate the high intensity resistance training that is generally~     believed necessary to increase muscle strength. Partial blood flow restriction (PBFR) to the~     exercising muscle has been reported to result in strength gains, while requiring lower levels~     of joint loading.2 This method may be better tolerated, enabling efficacious exercise in~     older adults who may not tolerate high knee joint loads.~      To asses the efficacy of a 4 week low-intensity resistance training program with concurrent~     application of PBFR to the exercising limbs to improve quadriceps strength and size, leg~     muscle power, and mobility in individuals at risk for developing symptomatic knee~     osteoarthritis,we will test the following hypotheses. In comparison with low-intensity~     resistance training without use of PBFR, a four-week low-intensity resistance-training~     program with PBFR will:~      Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee~     extensor strength~      Secondary Hypotheses:~        1. Increase quadriceps muscle volume assessed by MRI~        2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed~          stair climb~        3. Not adversely effect knee pain or quality of life assessed by the Knee injury and~          Osteoarthritis Outcome Score (KOOS) questionnaire~   "
158799|NCT01487512|"~     The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in~     healthy adult Taiwanese participants after oral administration of 4 different dose strengths~     of 8, 16, 32 and 64 mg under fasted conditions.~   "
158800|NCT01487499|"~     This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung~     cancer in two fashions:~        1. to implement a prospective clinical trial to test the feasibility and efficacy of~          intralesional chemotherapy as consolidative therapy immediately following standard~          systemic chemotherapy and radiation therapy for patients with limited stage SCLC by~          comparing tumor growth and survival rates of the treatment group and compare the~          outcomes to historical controls~        2. to implement a prospective clinical trial to test the feasibility and efficacy as~          measured by tumor growth and survival rates of intralesional chemotherapy for patients~          with recurrent SCLC after standard treatment.~   "
158801|NCT01487486|"~     To the best of the investigators knowledge, exhaustive characterization of the low and high~     abundant proteins and glyco-proteins of the Follicular Fluid (FF) has not yet been achieved.~     Such an analysis may provide critical molecular data on the role of the FF in oocyte~     maturation and may identify specific changes in the FF proteome of patients with gynecologic~     problems, such as Polycystic Ovary Syndrome (PCOS).~      Specific Aims~        1. To perform a comprehensive analysis of normal human FF using sensitive mass spectrometry~          in combination with conventional approaches for proteomic evaluation and using HPLC and~          Western blot for glyco-proteomic analysis.~        2. Characterize differential proteomic and glyco-proteomic patterns of the FF in normal~          women compared to lean and obese women with PCOS.~        3. To supplement the differential proteomic and glyco-proteomic analysis with steroid~          hormone analysis in all FF samples.~   "
158802|NCT01487473|"~     The main purpose of this study is to determine the degree to which Mindfulness-Based Stress~     Reduction, a group-based psychological therapy that includes mindfulness meditation~     exercises, reduces depression, anxiety, stress, pain intensity, and interference of pain with~     daily life among adult chronic pain patients.~      The second purpose is to examine the role of attention in improving psychological and~     physical health for chronic pain patients.~   "
158808|NCT01487395|"~     The early assessment of new drugs for Alzheimer's disease remains difficult because of the~     lack of predictive end-point. The use of a battery including different parameters could~     improve this early development of new drugs. Nevertheless, the interest of such a battery~     should previously be validated with the yet marketed AD drugs~   "
158809|NCT01487382|"~     This study is conducted in Japan. The aim of this study is to collect safety and efficacy~     data when using NovoRapid® (insulin aspart) in children with type 1 and type 2 diabetes under~     normal clinical practice conditions.~   "
158810|NCT01487369|"~     This study is conducted in Japan. The aim of this study is to collect data of production of~     insulin aspart specific antibody under normal clinical practice conditions.~   "
158811|NCT01487356|"~     Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy;~     however, few studies have evaluated specific factors that may influence the duration of~     withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection~     rate, one element of quality of colonoscopy, also need further study. By collecting data on~     hundreds of colonoscopies performed by 9 endoscopists, our goal was to identify factors~     associated with withdrawal time, inappropriately short withdrawal times, and polyp detection~     rate during colonoscopy.~   "
158812|NCT01487343|"~     The purpose of this study is to identify what makes it easier and what makes it harder to~     take oral chemotherapy.~   "
158813|NCT01487330|"~     The purpose of this first-in-human study is to assess the technical feasibility, deployment~     characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and~     delivery system in subjects with severe symptomatic aortic stenosis (AS).~      This is a single center, prospective, non-randomized, first-in-human investigational study~     without concurrent or matched controls.~   "
158814|NCT01487317|"~     The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in~     patients aged 75 and over, hospitalized with delirium.~      Study type : Interventional Study design: randomized, double-blind, placebo-controlled study~     during one month and a 11-month follow-up~   "
158815|NCT01487304|"~     This study is conducted in Europe. The aim of this study is to verify the therapeutic effects~     of low-dose hormone replacement therapy (HRT) in female patients over adequately long time~     period in normal clinical practice conditions in the Czech Republic.~   "
158816|NCT01487291|"~     At the Thrombophilia Clinic of the Hospital Federal dos Servidores do Estado do Rio de~     Janeiro there is a high prevalence of acute psychotic episodes, which allows the~     investigators to raise the suspicion that the thrombotic tendency or hypofibrinolysis play a~     role in the onset of the disease. It is striking that most of these patients, after some time~     on anticoagulants, no longer need to take psychiatric medication.~   "
158817|NCT01487278|"~     This is a large, community-based, cluster-randomized trial to compare routine prophylactic~     use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly~     during the third stage of labor.~   "
158818|NCT01487265|"~     Preclinical data in lung cancer cell lines showed that EGFR mutation can potentially be a~     positive predictor for sensitivity to BKM120. Furthermore, when the erlotinib-resistant model~     H1975 (LR858 and T790M mutation) was treated with BKM120, significant tumor control was~     observed (Novartis internal data). Therefore, combining BKM120 with erlotinib could~     potentially down-modulate PI3K-Akt activity resulting in a synergistic effect on cell growth~     inhibition and enhancing the response to erlotinib.~   "
158819|NCT01487252|"~     An estimated 23 million Americans, including adolescents and the elderly, suffer from~     circadian rhythm sleep disorders, such as delayed sleep phase disorder, advanced sleep phase~     disorder and winter depression. These conditions are characterized by persistent insomnia~     and/or excessive daytime sleepiness, impaired performance, reduced well being and lower~     quality of life. The negative symptoms result from a misalignment between the timing of sleep~     and the internal circadian clock. Clinical research has demonstrated that circadian rhythm~     sleep disorders are most effectively diagnosed (differentiated from other causes of insomnia)~     and treated if each individual patient's circadian phase is known. The timing of the master~     internal circadian clock is most reliably measured from the onset of the endogenous circadian~     rhythm of melatonin, a neuroendocrine hormone, as measured in dim light (dim light melatonin~     onset, or DLMO). However to date the reliable and valid assessment of the DLMO is limited~     to the research laboratory setting.~      This study is to test a streamlined procedure for the accurate assessment of circadian phase~     (DLMO) outside of the laboratory that will provide clinicians and researchers with a novel~     diagnostic and research tool. In this way the underlying neurobiological cause of a patient's~     insomnia and/or circadian rhythm disorder can more readily be diagnosed and treated.~      Specific Aim 1 is to validate procedures for at-home circadian phase assessment in a sample~     of healthy people. Validation will occur by (1) objectively measuring compliance to the~     at-home procedures and (2) comparing DLMOs collected at home to DLMOs collected in the~     laboratory, in a within-subjects counterbalanced design. Specific Aim 2 is to validate the~     same at home procedures in patients with delayed sleep phase disorder. Specific Aim 3 is to~     conduct rigorous analyses to inform future users which subject characteristics and light~     levels predict (1) compliance to the at home procedures and (2) valid at-home DLMOs.~      The results of this 3 year study will have substantial implications for the translation of~     basic and clinical research to the community: (1) the diagnosis and treatment of insomnia and~     circadian rhythm sleep disorders will be significantly enhanced, thus improving public health~     and safety, mood and quality of life, (2) community participation in research will be~     improved, particularly in vulnerable and under represented populations, thus increasing~     scientific knowledge and (3) research and clinical costs will be substantially reduced.~   "
158820|NCT01487239|"~     This study will be an open-label, non-randomized, absorption, metabolism, and excretion study~     of [14C]-GDC-0980 administered as a 10-mg oral dose to 6 healthy postmenopausal and/or~     surgically sterile female subjects following at least a 10-hour fast from food (not including~     water).~   "
158821|NCT01487226|"~     Purpose Primary endpoint~        -  To evaluate the 3-year disease free survival Second endpoints~        -  To evaluate the 3-year & 5-year overall survival To analyze the toxicity and the quality~          of life~   "
158822|NCT01487213|"~     The main objective of the study is to optimize the routines for follow-up after medical~     abortion in order to give women more autonomy by reducing the number of consultations~     involved and to reduce the frequency of postabortal curettage.~      This will be achieved by providing means for women for postabortal self-assessment with the~     use of a quantitative urinary hCG test.~   "
158823|NCT01487200|"~     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of~     FX006 in patients with osteoarthritis of the knee.~   "
158836|NCT01487031|"~     Autologous stem cell transplant (ASCT) is an important therapy for patients with multiple~     myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. It has been shown to improve~     progression free survival and overall survival. However, it is a challenging treatment~     process both physically and psychologically. It is a procedure with many side effects that~     can be uncomfortable, painful, and at times, difficult to endure. Complementary therapies,~     such as music therapy, have potential to be an important adjunct in palliation of symptoms in~     patients undergoing chemotherapy.~   "
158824|NCT01487187|"~     Very preterm babies frequently develop problems with their blood circulation during the first~     few days after birth. These circulation problems could affect the oxygen and blood flow to~     their brain and lead to effects such as bleeding in the head or delayed developmental~     milestones later in life. Currently the care for such problems may include transfusion of~     intravenous fluids or blood to the baby and/or giving the baby medications that can help~     circulation.~      The current practice at the delivery of these babies is to immediately clamp their umbilical~     cords after birth. Recent research studies have shown that giving more of the baby's own~     blood to them at birth by delayed cord clamping (waiting for clamping the cord for about~     30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that these~     babies may need later on. It may also improve their initial blood pressure and reduce the~     chances of bleeding in their heads.~      More research is needed to prove if either delayed cord clamping or milking the cord at birth~     will be better in terms of improving these babies' health.~      The aim of this study is to find out if adding some blood to these babies' circulation,~     through milking the cord at birth, could prevent or reduce the possible problems with blood~     circulation and the reduced blood flow to the brain that some of these babies may have after~     birth.~      The investigators will also investigate if milking the cord at birth could improve their~     long-term developmental outcome.~      Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3~     times prior to clamping, compared to immediate clamping after birth will improve systemic~     blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in~     the first 24 hours after birth)~   "
158825|NCT01487174|"~     This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung~     cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is~     hypothesized that KD019 can prolong survival compared with erlotinib.~   "
158826|NCT01487161|"~     The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006~     in patients with osteoarthritis of the knee.~   "
158827|NCT01487148|"~     This study is designed to compare the performance of the P-1000 System, POCARED's Rapid~     Diagnostic System which uses optical fluorescence analysis, to standard methods of~     uropathogen quantification and identification.~   "
158828|NCT01487135|"~     The purpose of this study is to evaluate the effect of EVP-6124 at therapeutic and~     supratherapeutic concentrations on cardiac repolarization in healthy subjects.~   "
158829|NCT01487122|"~     This randomised controlled trial aims to compare the effect of microwave diathermy~     (continuous and pulsed modes) with sham microwave diathermy in nonspecific chronic neck pain~     patients. Every patient will also be treated by exercise and transcutaneous electrical~     neurostimulation (TENS). The primary endpoint is to establish whether the use of microwaves~     is justified in terms of pain relief or reduction of disability in this patients.~   "
158830|NCT01487109|"~     This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499~     for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are~     currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or~     angiotensin II receptor blocker (ARB).~   "
158831|NCT01487096|"~     The primary objective of this study was to determine the safety and efficacy of teriflunomide~     in multiple sclerosis (MS) with relapses.~      Secondary objectives were:~        -  To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI)~          variables as well as clinical and quality of life measures.~        -  To investigate the pharmacokinetic and pharmacodynamic relationships.~   "
158832|NCT01487083|"~     The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in~     participants with schizophrenia.~   "
158833|NCT01487070|"~     Primary objective of this trial will be to evaluate the safety and efficacy of intravitreal~     injections of Macugen (pegaptanib sodium) when given at least 7-14 days prior to vitrectomy~     in subjects with tractional retinal detachment (with or withoutmacular involvement) secondary~     to proliferative diabetic retinopathy.~      Secondary objective is to evaluate regression of neovascularization and progression of~     macular traction utilizing OCT and fundus photographs.~   "
158834|NCT01487057|"~     The continuous increase of the incidence of the thyroid cancer in the last years has taken~     this neoplasia among the first 4 frequent cancers in the cancer registry of the Institute of~     Oncology Prof.Ion Chiricuţă from Cluj-Napoca (IOCN), with a total number of over 470 new~     cases per year, added to the other 3700 cases already being in the evidence of the Institute.~      The radical treatment brings for a long term a compensated chronic drug induces mYxoedema~     with it's important side effects. Among these one can find the dislipidemia and the change of~     the high sensitive C reactive protein (hsCRP) serological value. In the last years, many~     epidemiological studies have confirmed the fact that the patients with a high serological~     value of the hsCRP present a higher risk for the coronary disease and heart attack.~      Prospective studies developed in european countries and in USA have provided results that are~     related to the predictive value of the hsCRP determinations over the cardiovascular risk.~     Thus, hsCRP is an indirect risk factor for the coronary disease. The risk for cardiovascular~     disease is 2 to 7 times higher at the people with a high level of hsCRP comparing to ones~     with low levels; the increase of the hsCRP serological value can be determined several years~     before the clinical debut of the coronary disease.~      The screening for this population group with a high risk can introduce in use the prevention~     of the cardiac pathology and change the approach to the monitoring of the patients with~     thyroid cancer. A selection protocol will be elaborated for the patients that will withdraw~     the hormone treatment by using recombinant thyroid stimulating hormone (TSH) or will have~     personalised monitoring algorithm, with a shortening of the hormone treatment withdrawal.~   "
158835|NCT01487044|"~     Establish the efficacy of initial high frequency loading of intravitreal pegaptanib bi-weekly~     during the initial treatment period when the VEGF levels are the greatest and then gradually~     extending the administration frequency to monthly as homeostasis ensues for the treatment of~     DME, as measured by best-corrected visual acuity.~   "
158882|NCT01486433|"~     The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty~     acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.~   "
158883|NCT01486420|"~     The purpose of the study is to investigate which strategy is superior in trigger finger~     Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid~     injections.~   "
158837|NCT01487018|"~     Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex~     can be considered a formidable challenge, even to the skilled surgeon. However, the~     development of Computer-Assisted Navigation technology Offers new opportunities in the~     treatment of such deformities. With the help of navigation system,pre- and~     intraoperatively,the objective of any supporting medical device for reconstruction of the~     orbitozygomaticomaxillary complex would be visualization of the real and desired positions of~     the zygoma. In this randomized controlled trial, the investigators would like to evaluate the~     feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in~     cases of established post-traumatic deformities using computer assisted navigation.~   "
158838|NCT01487005|"~     The Multicenter Ozone Study in Elderly Subjects will investigate whether short-term exposure~     of elderly volunteers to ambient levels of ozone in a controlled exposure setting causes~     acute cardiovascular responses as assessed by changes in blood pressure, cardiac function,~     and systemic biomarkers of inflammation, endothelial dysfunction, and thrombosis.~   "
158839|NCT01486992|"~     There are few studies about 2nd line treatment in advanced esophageal carcinoma (AEC), some~     showed that irinotecan may be effective. The investigators previous study has shown the~     efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study,~     the investigators would like to observe the efficacy and safety of Nimotuzumab plus~     Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of~     PTX/DDP.~   "
158840|NCT01486979|"~     This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of~     systemic absorption of estradiol during treatment with two different doses of estradiol in~     postmenopausal women with atrophic vaginitis.~   "
158841|NCT01486966|"~     This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of~     insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a~     basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.~      The trial adopts a group sequential design, where the analysis of the primary efficacy~     endpoint will be performed at the interim analysis, in addition to the final formal analysis.~     The decision to continue or stop the trial will be based on the result of the interim~     analysis.~   "
158842|NCT01486953|"~     The aim of the current study was to compare the effects of sevoflurane and desflurane on~     respiratory mechanics in patients undergoing repair of pectus excavatum.~   "
158843|NCT01486940|"~     This trial is conducted in Europe and South America. The aim of this trial is to compare the~     glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human~     soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.~   "
158844|NCT01486927|"~     This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study~     comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period~     (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety,~     efficacy, and repeat PK period (Part 3) and also includes a surgical sub-study for subjects~     enrolled in Parts 2 and 3.~   "
158845|NCT01486914|"~     This trial is conducted in Europe. The aim of this trial is to compare insulin aspart~     produced by current process and the NN2000 process.~   "
158846|NCT01486901|"~     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence~     between two formulations of Insulatard® in healthy subjects.~   "
158847|NCT01486888|"~     This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence~     between two formulations of Mixtard® 30 in healthy subjects.~   "
158848|NCT01486875|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of~     serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects~     with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.~   "
158849|NCT01486862|"~     This trial is conducted in North America. The aim of this trial is to investigate the~     efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving~     glycaemic targets on OADs (oral anti-diabetic drugs).~   "
158850|NCT01486849|"~     A Phase II, double-blind, randomized, placebo-controlled ascending dose titration study to~     evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple~     ascending doses of CK-2017357 to an individual patient maximum tolerated dose (MTD), using a~     within-patient twice daily (BID) dose-titration regimen in ALS patients on 50 mg riluzole~     once daily (QD).~   "
158851|NCT01486836|"~     The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox~     DX system.~      No hypothesis has been defined.~   "
158852|NCT01486823|"~     This is a study in healthy volunteers designed to investigate the PK following intravenous~     and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of~     MLDL1278A after subcutaneous administration will be determined.~   "
158853|NCT01486810|"~     The proposed protocol is an open-label pilot study of the treatment of cocaine dependence~     using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12~     patients in an eight-week open-label trial to obtain preliminary data regarding the safety,~     tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence~     and to determine an effective dosage range.~   "
158854|NCT01486797|"~     The purpose of this study is to evaluate the safety and efficacy of NOX A12 in combination~     with a background therapy of bendamustine and rituximab (BR) chemotherapy in previously~     treated patients with chronic lymphocytic leukemia (CLL).~   "
158855|NCT01486784|"~     This is a phase I/II, open-label non-randomized study using an investigational new drug,~     TL32711, in patients with AML, MDS and ALL. This study will target subjects 60 years of age~     and older (with non-M3 AML who have relapsed or refractory disease after standard therapy or~     who are newly diagnosed )and subjects 18-59 (relapsed or refractory after failing 3 prior~     lines of therapy). This study will also target subjects 18 years of age and older with MDS~     and ALL.~   "
158856|NCT01486771|"~     Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic~     Retinopathy (PDR) and reduce the need for retinal photocoagulation.~   "
158884|NCT01486407|"~     This study will evaluate using intraosseous vascular access and intravenous vascular access~     to give patients the necessary medications to perform rapid sequence intubation, for patients~     with airway difficulties. The investigators think the device operator will find the~     intraosseous and intravenous routes equal for drug delivery.~   "
158857|NCT01486758|"~     This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical~     effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial~     Virus (RSV) bronchiolitis.~      HYPOTHESES~      In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo)~     will result in:~        1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum~          and nasal wash measured on day 8 after randomization.~        2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks~          3-52 following randomization.~   "
158858|NCT01486745|"~     This is a prospective, multi-centered study to assess whether urine metabolomics can play a~     role in the screening of colorectal cancer (CRC). Urine samples will be collected from 1000~     patients going through an established CRC screening program, and from a further 500 patients~     who already have a diagnosis of CRC. Using nuclear magnetic resonance (NMR) spectroscopy, the~     1H NMR spectrum of urine samples will be analyzed for specific metabolites, and establish the~     metabolomic signature of colorectal cancer. The results from metabolomic urinalysis of this~     screening cohort will be compared with results from colonoscopy, histological descriptions,~     fecal occult blood testing (FOBT), and fecal immune testing (FIT) to assess the accuracy of~     urine metabolomics in identifying patients with polyps and malignancies. The urine~     metabolomic results from the colorectal cancer group will be correlated with operative,~     histological and clinical staging to define the role of urine metabolomics in assessing~     colorectal cancer type, location and stage. Additionally approximately 300 urine samples from~     breast cancer patients and 300 from prostate cancer patients will be collected to validate~     that the colorectal cancer signature is unique.~   "
158859|NCT01486732|"~     This is randomized placebo-controlled trial to recognize new cell regeneration in the brain~     using FLT-PET.~   "
158860|NCT01486719|"~     Sensory reconstruction of the finger pulp is a challenging problem. This article reports~     repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches~     of the proper digital nerves (PDNs) were used for maximal sensory restoration.~   "
158861|NCT01486706|"~     Overactive bladder (OAB) syndrome as defined by International Continence Society is a~     pathological condition characterized by irritative symptoms: urinary urgency, with or without~     incontinence, urinary frequency and nocturia. The syndrome often seriously compromises the~     quality of life of the patients. The etiology of the OAB is considered multifactorial. Neural~     plasticity of bladder afferent pathways is one of the proposed mechanisms of OAB. The~     detrusor muscle itself has for many years been the target for drug treatment such as~     antimuscarinics. However, depression of detrusor contractility, may results in a reduced~     ability to empty the bladder and lead to some sympathetic adverse effects, which limits the~     treatment of OAB. Currently the focus of OAB treatment has changed to other bladder~     structures/mechanisms, such as afferent nerves and urothelial signaling as targets for~     intervention. C-fiber bladder afferents nerves may be critical for symptom generation in~     pathologic states such as OAB because these fibers demonstrate remarkable plasticity.~     Up-regulation of bladder C-fiber afferent nerve function may also play a role in urge~     incontinence, overactive bladder (OAB) and sensory urgency. The mechanism of Gabapentin's~     action for neuropathic pain has not been fully elucidated but is appears to have inhibitory~     activity on afferent C-fibers nerve activity; moreover, several studies had established the~     safety of Gabapentin in its treatment of different conditions. Due to the proposed mechanism,~     the investigators suggest that Gabapentin may be a new alternative for treating OAB.~   "
158862|NCT01486693|"~     The purpose of this study was to evaluate long term efficacy and safety of topical~     ganciclovir treatment in Cytomegalovirus (CMV) anterior uveitis.~   "
158863|NCT01486680|"~     Type 2 diabetes (T2DM) and obesity are becoming increasingly common in New Zealand (NZ) and~     worldwide. Both are associated with a risk of early mortality (death). Whilst weight loss~     surgery is known to be effective for weight loss, current research suggests that it may also~     be effective in resolving T2DM in around 60-80% of patients, with some no longer requiring~     their medication. The mechanism for this remains unclear.~      Two main types of weight loss surgery are performed in NZ public hospitals, which include~     gastric bypass and sleeve gastrectomy. The gastric bypass is a more complex procedure~     compared to the sleeve gastrectomy. Whilst both appear to be effective for weight loss (with~     most patients losing more than 60% of their excess weight), it is still not known which one~     is better for treating T2DM.~      This study will therefore compare which of these two surgical procedures is most effective at~     treating T2DM in obese patients, as well as comparing whether there are any differences in~     the amount of weight lost, side effects and quality of life.~   "
158864|NCT01486667|"~     Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical~     practice, and share a number of symptoms and clinical features. It has been shown that~     hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and~     adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the~     time-course and effect of treating subclinical hypothyroidism in OSA patients on the~     respiratory events during sleep is not known.~      Subclinical hypothyroidism is associated with an increased risk of coronary heart disease~     (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism and the effect of~     thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum~     high-sensitivity C-reactive protein (hs-CRP), than healthy subjects; however, the effect of~     levothyroxine is controversial.~      This project will help us to know if the treatment of subclinical hypothyroidism will improve~     the symptoms and reduce the progression of OSA, which may improve patients' quality of life~     by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases,~     etc.) or may even reduce mortality.It will help us to know the effect of subclinical~     hypothyroidism treatment on of lipid profiles and hs-CRP.~   "
158865|NCT01486654|"~     The purpose of this study is to evaluate the effectiveness of small amounts of electrical~     current, applied without surgery to the brain, in combination with speech-language treatment,~     on the language outcome of study subjects with nonfluent aphasia (i.e. difficulty with the~     comprehension and expression of spoken and written language) following a stroke.~   "
158866|NCT01486641|"~     The purpose of this study is to determine whether the anterolateral in comparison to~     posterolateral approach to the hip arthroplasty gives an equal or better clinical results.~   "
158867|NCT01486628|"~     It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose~     escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in~     healthy volunteers.~      Objectives are to determine:~        1. the maximal tolerated dose of SC ND-0612~        2. the steady state plasma concentration of LD and CD following SC ND-0612 administration.~      Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential~     manner.~   "
158868|NCT01486615|"~     Background: Benzodiazepine, a common premedicant, suppresses endogenous melatonin levels and~     thus paradoxically increases episodes of arousal during sleep and thus causes restlessness~     and hangs over effects. Adding melatonin to it may decrease nocturnal arousal and promote the~     perception of sound sleep in the perioperative period.~      Methods: Eighty patients (ASA 1&2) with anxiety VAS ≥ 2 posted for general anaesthesia will~     be randomly assigned to receive 0.5 mg alprazolam (Group A), 3 mg melatonin, a combination of~     0.5 mg alprazolam and 3 mg melatonin (Group AM), or a similar looking placebo (Group P),~     approximately 90 minutes before surgery.~   "
158869|NCT01486602|"~     This phase I trial studies the side effects and the best dose of hypofractionated radiation~     therapy when given together with chemotherapy in treating patients with stage III non-small~     cell lung cancer that cannot be removed by surgery. Hypofractionated radiation therapy~     delivers higher doses of radiation therapy over a shorter period of time and may kill more~     tumor cells and have fewer side effects. Drugs used in chemotherapy, such as paclitaxel and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving~     hypofractionated radiation therapy together with chemotherapy may kill more tumor cells.~   "
158870|NCT01486589|"~     The aim of the study is to test the hypothesis that impaired cardiac autonomic function~     predicts adverse outcome in unselected patients presenting in the emergency ward.~   "
158871|NCT01486576|"~     The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential~     nephrotoxic and examine the effects on the circulation and kidneys during administration of~     HES during surgery.~   "
158872|NCT01486563|"~     The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential~     nephrotoxic and examine the effects on the circulation and kidneys during administration of~     HES during surgery.~   "
158873|NCT01486550|"~     The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential~     nephrotoxic and examine the effects on the circulation and kidneys during administration of~     HES during surgery.~   "
158874|NCT01486537|"~     The aim of this study is to evaluate the level of acidity of blood samples that are been~     taken from pulp chambers of primary molars undergoing pulpotomy or pulpectomy procedures. Our~     hypothesis is that samples from teeth undergoing pulpectomy would be acidic while samples~     from teeth undergoing pulpotomy would bo neutral.~   "
158875|NCT01486524|"~     The overall purpose of the study is to determine whether either of the Improved Response~     Polymorphisms (IRPs) individually predicts a differential DrotAA treatment effect in patients~     with severe sepsis and high risk of death. This will be an international, multicenter,~     prospective-retrospective, nonrandomized, controlled, outcome-blinded, genotype-blinded,~     matched-patients study. No prospective enrollment or treatment of patients will occur under~     this protocol. Retrospectively collected clinical data and DNA samples will be analyzed for~     existing cohorts of patients with severe sepsis who were previously treated with DrotAA~     (treatment group) or not (control group) as part of their standard care in an ICU.~   "
158876|NCT01486511|"~     Major surgery is associated with a postoperative hypercoagulable state related to the~     surgical trauma that may lead to thromboembolic complications. To the investigators~     knowledge, only two series have reported the risk of PE after liver surgery with an incidence~     of up to 6.3% The purpose of this study is to identify the independent risk factors~     associated with the development of PE after elective liver surgery.~   "
158877|NCT01486498|"~     Grass pollen and house dust mites (HDM) are the most common allergens causing allergic~     rhino-conjunctivitis (RC) and/or asthma (A). Subcutaneous allergen specific immunotherapy~     (SCIT) reduces symptoms and use of medication. The purpose of SABAL is to assess the effect~     of SCIT on disease severity classifications in terms of number of days affected- and sick~     days on patients with grass pollen and/or HDM induced disease. These outcome measures will be~     gathered in one single measure: Quality Adjusted Life Years (QALY)~   "
158878|NCT01486485|"~     Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is~     known to be an independent risk factor for mortality. Renal replacement therapy (RRT) is the~     mainstay of supportive treatment of patients with severe acute kidney injury. The goal of RRT~     is to achieve adequate correction of uremia, electrolyte abnormalities, and volume overload~     while ensuring good hemodynamic tolerance. The advantages of continuous renal replacement~     therapy (CRRT) are increased time-averaged dialysis dose, less hemodynamic instability, and~     possibly, removal of high molecular weight solutes, such as inflammatory cytokines. Solute~     removal can occur by several different mechanisms in CRRT. For relatively small solutes, the~     importance of diffusion and convection is emphasized, for solutes of larger molecular weight,~     the importance of convection and adsorption is emphasized. The ability of a specific CRRT to~     remove a certain solute is determined by membrane characteristics. But actual measurements of~     middle molecule clearance in large clinical trials have not been available in most trials.~      During CRRT, blood is conducted through an extracorporeal circuit, circuit clotting is a~     major problem in daily practice of CRRT, increasing blood loss, workload, and costs. Early~     clotting is related to bioincompatibility, critical illness, vascular access, CRRT circuit,~     and modality. Therefore, one major intervention to influence circuit survival is~     anticoagulation. However, systemic anticoagulation, usually with heparin, can produce~     hemorrhagic complications in patients at high risk of bleeding. To minimize the risk of~     bleeding, a number of alternative regimens has been proposed, however, each of those methods~     has its own limitations and complication. Nafamostat mesilate, a serine proteinase inhibitor,~     while inhibiting various clotting factors in filter circuit, is characterized by short half~     life resulting in little systemic anticoagulation effect. A recently developed CRRT AN69ST~     membrane® (Gambro Inc) is coated with a polyethylene imine (PEI, cationic biopolymer) on the~     membrane surface. Once adsorbed onto the membrane, heparin keeps its anticoagulant~     properties. Therefore CRRT has been managed without systemic administration of heparin.~      The investigators will conduct a multicenter prospective randomized controlled open-label~     trial which compares the difference in circuit survival between between nafamostat infusion~     and heparinized saline priming as anticoagulation for CRRT. The primary end-point of this~     study is circuit survival, the time of 1st membrane exchange. The secondary end-point is~     clearance of small molecule (urea) and middle molecule (β2 microglobulin) at 0, 1, 6, 24h,~     ACT(activated coagulation time) measurements after 1hr of the CRRT, Hemorrhagic complication.~     This is a noninferiority trial. The aim is to demonstrate that nafamostat infusion is not~     inferior to the heparinized saline priming. For this purpose, at least 80 subjects (a total~     of 160) would be required for each group if type I error rate is 5% and type II error is 20%~     given 20% of drop-out rate during the study period. Block randomization will be used by means~     of a dedicated website.~      There are still conflicting data on the effective exchange time of circuit membrane. Our~     study may help to improve prognosis in patients with severe AKI.~   "
158879|NCT01486472|"~     S-1 is an effective drug in gastric cancer (GC) for palliative chemotherapy in Eastern and~     Western patients. Recently, S-1 has been also reported to be an effective adjuvant therapy~     for GC patients who received D2 surgery in Eastern Asian patients.~      Recently, the development of lacrimal drainage obstruction (LDO) caused by S-1 has been~     reported from some case and small-sized studies. The incidence of developing LDO has been~     estimated to about 15~20% of patients receiving S-1 therapy in some retrospective studies.~     However, there is no prospective report on the incidence of LDO in patients receiving S-1~     chemotherapy. Moreover, the mechanism of developing S-1-induced LDO has not been systemically~     studied until now. Suggested mechanism of LDO involves direct secretion of S-1 into the tear.~      Therefore, this study was initiated to prospectively investigate the incidence of LDO in GC~     patients receiving adjuvant S-1 chemotherapy. In addition, the correlation between the~     development of LDO and the concentration of S-1 (or its metabolites) in tear and plasma will~     be explored. These results will help clinicians identify patients who are at high risk of~     developing S-1-associated LDO.~   "
158880|NCT01486459|"~     Small cell lung cancer is an aggressive neuroendocrine tumour that often presents with~     extensive (metastatic) disease. Chemotherapy is the mainstay of treatment, with radiotherapy~     to the primary tumour. It is now part of care to also offer Prophylactic Cranial Irradiation~     (PCI) in order to prevent spread of the cancer into the brain.~      Cognitive impairment can result after cranial irradiation. Lithium is thought to be~     neuroprotective. It is hypothesized that lithium administration with PCI will be safe,~     tolerable and feasible, and can be studied to prevent or ameliorate the ensuing cognitive~     impairment.~   "
158881|NCT01486446|"~     This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel~     group study with XPF-002 applied twice daily over 14 or 21 days in patients with~     Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether~     XPF-002 is safe and effective in the treatment of pain caused by IEM.~   "
158888|NCT01486355|"~     Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early~     two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality~     compared with the WHO strategy of one dose of MV at 9 months.~      Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the~     standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of~     age1. As in a previous trial it is expected that the beneficial effect is strongest for~     girls.~      Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles~     antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than~     children receiving MV at 4 months with no detectable MatAb.~      Implications: These hypotheses are based on a previous RCT showing strong beneficial effects~     of providing an early measles vaccine, in particular among children with MatAb.~   "
158889|NCT01486342|"~     Despite decades of research, the mortality in acute lung injury remains very high and~     treatment options are very limited. Given these facts, the best treatment modality may be in~     prevention of this lethal syndrome.~      Historically, imaging has played a crucial role in understanding ALI. The appearance of chest~     radiography is one of the consensus criteria in defining ALI, and commuted tomography (CT)~     scans further advanced the understanding of the pathoanatomy of ALI. While valuable, these~     imaging modalities are nonspecific and do not incorporate functional cellular physiology.~      PET imaging measures concentrations of radioisotopes in the body. By embedding in, but not~     altering molecules, the natural fate of these tracers can be studied with PET imaging.~     Advances in the understanding of ALI include blood flow distribution, as well as the response~     to alveolar recruitment maneuvers and prone positioning. Not all patients who are receiving~     mechanical ventilation develop ALI. Inflammation in the lungs is known to play a key early~     role in the development and progression of ALI. Secondary to inflammation, the lungs develop~     edema and do not exchange oxygen as well. This early inflammation is in part driven by a~     specific type of immune cell called the neutrophil. These cells seem to travel and become~     sequestered in the lung- they are recruited to the lung during this inflammatory stage.~     When there, these neutrophils release inflammatory substances which are integral in the~     development of ALI. Neutrophils use primarily glucose as a fuel source. The radio isotope~     [18F]Fluorodeoxyglucose (FDG)is a glucose analog and therefore taken up/ingested by the~     neutrophils as a part of their normal metabolism. Because of this fact, positron emission~     tomography (PET) using the radio isotope [18F]FDG is a highly sensitive marker to look at the~     recruitment of neutrophils to the lung, therefore quantifying the degree of pulmonary~     inflammation prior to the development of ALI.~      The investigators seek to examine the relationship of pulmonary inflammation in patients at~     risk for ALI, but without clinical evidence of the syndrome. The investigators seek to enroll~     ten patients in a pilot trial.~   "
158890|NCT01486329|"~     First-in-human phase I dose escalation study in patients with locally advanced, inoperable~     and stage IV pancreatic cancer to examine safety, tolerability, and immune response to the~     investigational VEGFR-2 DNA vaccine VXM01 to examine safety and tolerability, clinical and~     immunogenic response to the investigational vascular endothelial growth factor receptor 2~     (VEGFR-2) DNA vaccine VXM01, and to define the maximum tolerated dose.~   "
158891|NCT01486316|"~     The purpose of this study is to characterize the feasibility and impact of a diagnostic tool~     that may help clinicians identify when patients are at higher risk of visiting the hospital~     for a heart failure event. The study will use a non-experimental device that is inserted just~     under the skin of the chest, which continuously monitors the heart rhythm in combination with~     an experimental web-based heart failure risk status. Patients with atrial fibrillation and~     heart failure will be evaluated to collect data about the potential of this risk status to~     help improve patient outcome.~   "
158892|NCT01486303|"~     Facial Cosmetic Acupuncture technique includes wrinkles, acupoints and muscle points on the~     face, head and neck. This study is designed to determine the efficacy and safety of Facial~     Cosmetic Acupuncture on skin rejuvenation.~   "
158893|NCT01486290|"~     The purpose of this study is to find ways to identify barriers that affect self care in older~     adult with diabetes and to provide cost effective coping strategies to improve clinical,~     functional and psychosocial measures.~   "
158894|NCT01486277|"~     The purpose of this study is to determine the overall cutaneous response rate (participants~     who achieve a complete response or partial response) based on the modified severity weighted~     assessment tool criteria.~   "
158895|NCT01486264|"~     This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals~     (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the~     response to treatment is comparable in both how it works and any side effects. Xeomin® is~     approved by the United States Food and Drug Administration (FDA) for the treatment of~     cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment~     intervals. An investigational use is one that is not approved by the FDA.~   "
158896|NCT01486251|"~     The purpose of this study is to evaluate and quantify the dynamic modifications of tumor~     blood perfusion on axitinib therapy in patients with refractory mCRC for each dose of~     Axitinib.~   "
158897|NCT01486238|"~     Intravitreal injections of pegaptanib every 4 weeks will be efficacious in treating Diabetic~     Macular Edema (DME), as compared to injections every 6 weeks.~   "
158898|NCT01486225|"~     The purpose of this study is to identify the nature of skin lesions that develop on contact~     with the grip-top bands of medical compression stockings, which are composed mainly of~     silicone.~   "
158899|NCT01486212|"~     Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms~     metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their~     structure can react with other molecules resulting in cell damage. This damage is due to~     several mechanisms.~      This is e.g what happens when human tissue is cut of from blood supply for a time, and the~     blood supply is again restored. The damage following the restoration of blood is known as~     ischemia-reperfusion injury. The reopening of the vessels and thereby supplying oxygenated~     blood to the deprived tissue can in it self contribute to cell death due to excessive amounts~     of free radicals. Antioxidants can neutralize free radicals and thereby minimize their~     damage.~      The purpose of the investigators methodology study is to make an ischemia-reperfusion model~     on healthy volunteers (on the lower limb) to examine the expression of markers that are~     expressed in the muscle and the blood when blood supply is cut of to an area and later~     restored. The investigators wish to measure the product of the damage caused by free radicals~     and the levels of antioxidants.~      If the investigators can produce elevation of oxidative and inflammatory markers, this model~     can be used to test antioxidative intervention.~   "
158910|NCT01486069|"~     The present study intends to clarify whether there is positional mandibular stability in~     patients to be submitted to orthognathic surgery. In case of any instability exists, it is~     needed to understand if this could be related to a particular type of dentofacial deformity~     or could have any short-term or long-term influence on outcomes of the orthognathic surgery.~   "
158900|NCT01486199|"~     The investigators are developing a new nuclear medicine imaging technique for measuring~     liquid absorption in the airways that can be applied to screen new medications being~     developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the~     small molecule radiopharmaceutical Indium 111-diethylenetriaminepentaacetic acid (In-DTPA)~     will indicate changes in liquid absorption in the airways and demonstrate whether new CF~     medications will be effective. In this study the investigators will further develop this~     technique through testing involving pediatric CF patients and healthy control subjects.~   "
158901|NCT01486186|"~     The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine~     for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).~   "
158902|NCT01486173|"~     The main goal of this study is to determine the association between:~        -  the quantity of mother's milk and duration of breastfeeding~        -  the intake of polyunsaturated fatty acids and iron during hospitalization and the~          development of preterm infants born with a GA < 32 weeks.~   "
158903|NCT01486160|"~     This study will be conducted in a 208-bed nursing home in Maribor. The investigators will~     observe a group of a 100 nursing-home residents and 50 health care workers- employees in the~     nursing home- in a six months period.Influenza vaccination status will be recorded in all~     participants at the beginning.~      At the beginning and at the end of the study the blood samples for vitamin D concentration~     determination and nasopharyngeal swabs for molecular detection of respiratory viruses will~     taken in all of the participants.~      The study will observe number of viral respiratory tract infection in participants and~     identify the viral etiology of infections during 6 months observational period.Nasopharyngeal~     swab and blood sample will be taken in each of the participant who will suffer an acute~     respiratory tract infection (upper or lower respiratory tract infection) and viral agents of~     respiratory tract diseases will be searched for. The investigators will try to detect~     different viral agents of respiratory tract infection: human rhinoviruses, enteroviruses,~     influenza A, B, parainfluenza 1-4, respiratory syncytial virus, human coronaviruses, human~     metapneumovirus, adenoviruses and human bocavirus with newer molecular methods (real-time~     polymerase chain reaction, real-time reverse transcriptase polymerase chain reaction) in~     nasopharyngeal swab and in blood sample of the participants.~      During the study period the investigators will monitor the daily number of visitors (adults,~     preschool children and pupils) in each nursing home room. The epidemiological aspect of~     respiratory viral infection will be assessed.~      Our study hypothesis is that lower respiratory tract infections in elderly can be caused by~     viruses other than influenza.~      The investigators would like to know if hypovitaminosis D is a risk factor for respiratory~     tract infections in nursing home residents and employees.~      The investigators would also like to know if the number of respiratory tract infections in~     elderly correlates with the number of visitors in nursing home, small children in particular.~   "
158904|NCT01486147|"~     The objective of the study is to validate a visual method of presenting nutritional~     information by determining if users of the visual method remember food properties better than~     users given the same information in a non-visual form with texts and tables.~   "
158905|NCT01486134|"~     Object of the study:~      To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular~     carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of~     reduction of the number of procedure required to obtain complete ablation of the tumors.~      Experimental plan :~      This pilot study consist to perform in a single center a single procedure of the multipolar~     RF ablation under MR temperature monitoring for the treatment of up to three HCC with~     diameter ranging from 5 cm and 10 cm in 20 inoperable patients. The main judgement criterion~     of the study will be the rate of complete ablation one month after one RFA procedure~     performed under MR temperature monitoring. The secondary criteria are, the 2-years local~     recurrence rate (after the first initial RF ablation procedure performed under MR temperature~     imaging ± additional RF ablation procedures under ultrasound monitoring in case of remnant~     viable foci of tumor), the potential reduction of the number of RF procedures required to~     achieve complete necrosis and the complication rate of RF ablation procedure performed under~     MR temperature monitoring.~      In exploratory attempt, the study will include comparative assessment of these criteria with~     a historic leg of patients previously treated by the same operator in the same center for~     similar large tumor by multipolar RFA but using exclusively ultrasound monitoring.~   "
158906|NCT01486121|"~     Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized in~     Intensive Care Unit (ICU). That is called  sedation  and aimed to reduce both pain and~     anxiety and also to allow an effective and atraumatic mechanical ventilation. However,~     sedation excess and ventilator support excess, both in duration and intensity, are associated~     with an excess morbidity. Patients usually are systematically sedated after having been~     intubated. Then, sedation is stopped first before ventilator support is weaning. Several~     studies shown that rationalized protocols of sedation and ventilation orderings had a~     beneficial impact on non surgical patients' outcome. Feasibility of these protocols in~     surgical patients is still unknown. Moreover, no study has evaluated an optimized paired~     strategy of sedation-ventilation based on the priority setting of ventilation. This priority~     setting of ventilation should increase patient's comfort in spite of increasing sedatives and~     analgesics dosing. An paired sedation-ventilation protocol optimized for both duration and~     intensity of these treatments could improve surgical patients' outcome in ICU.~   "
158907|NCT01486108|"~     Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo~     controlled pilot study burst stimulation seemed superior to tonic stimulation over a period~     extending more than 2 years, and even though an incidental finding, this design seemed~     capable of suppressing pain without mandatory induction of paresthesias. This permits for the~     first time to scientifically prove that spinal cord stimulation is better than placebo~     stimulation. A study was therefore initiated to find out whether spinal cord stimulation is~     indeed capable of suppressing neuropathic limb pain in a placebo controlled way.~   "
158908|NCT01486095|"~     Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double~     stent technique is used) is associated with a higher risk for stent thrombosis. Different~     factors may play a role in the higher risk for stent thrombosis in bifurcation lesions.~     Possible mechanisms are delayed endothelialisation due to the action of the drug, coating~     polymers, or overlapping stent segments, incomplete stent apposition at specific sites in the~     bifurcation lesion and higher thrombogenicity due to turbulent flow at the bifurcation site.~     In human pathological data, the RUTSS (ratio of uncovered to total stent struts) appears to~     be the most powerful predictor of stent thrombosis.~      This prospective study will assess the differences in stent strut coverage and stent strut~     apposition after complex bifurcation lesion treatment with the dedicated AXXESS Biolimus~     A9-eluting bifurcation stent at the bifurcation site and additional Biomatrix Biolimus~     A9-eluting stents in the distal main vessel and the side branch versus treatment with the~     culotte technique using the Xience Prime everolimus-eluting stents.~   "
158909|NCT01486082|"~     Due to the high rate of resistance to clarithromycin in our area the investigators proposed~     an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in~     order to improve the rate of eradication.~   "
158913|NCT01486030|"~     This is a prospective, single-center study that aims to evaluate the acute and delayed effect~     of exercise stress testing on the peripheral gene expression (PGE) levels using a predefined~     gene set established in the Corus CAD (Age/Sex/Gene Expression score - ASGES) test in subject~     with known obstructive coronary artery disease (CAD) and in control subjects (without known~     CAD).~   "
158914|NCT01486017|"~     The purpose of this study is to determine the relative bioavailability and pharmacokinetic~     profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the~     safety and tolerability after a single dose of three different strengths of a new tablet~     formulation.~   "
158915|NCT01486004|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol and~     norethindrone (administered once a day) and on the levels of progesterone, luteinizing~     hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol~     and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen.~     Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen~     will be studied. Steady-state is a term that means that the drug has been given long enough~     so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is~     being investigated for the treatment of chronic hepatitis C virus (HCV) infection.~     Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the~     body and eliminated from the body. A contraceptive is a method that prevents pregnancy.~   "
158916|NCT01485991|"~     The purpose of this study is to demonstrate the efficacy of TMC435 in combination with~     peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority~     compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously~     failed PegIFN.~   "
158917|NCT01485978|"~     This is a phase III, multi-centre, randomised, placebo-controlled, patient and~     investigator-blind study in paediatric patients with early stages of Alport syndrome to~     assess the safety and efficacy of the ACEi ramipril in slowing disease progression.~      Alport syndrome stages that describe the extent of renal damage and loss of function are~     defined as:~        -  0 Microhaematuria without microalbuminuria (usually at birth)~        -  I Microalbuminuria (30-300 mg albumin/gCrea)~        -  II Proteinuria >300 mg albumin/gCrea~        -  III > 25% decline of normal renal function (creatinine clearance)~        -  IV End stage renal failure (ESRF)~      Eligible patients with Alport stages 0 and I will be randomly assigned at a 2:1 ratio to~     receive once daily ramipril or placebo. In addition, Alport stage II patients may be treated~     open Label. Eligible patients who, or whose parents/legal guardian refuse randomisation after~     eligibility is confirmed, and patients who have been treated with ramipril prior to the~     study, may be treated open-label with ramipril as per protocol. The total number of patients~     will not exceed 120, with the number of randomised patients not exceeding 60, and the number~     of patients treated open label from Day 1 of the study aimed to be approximately 60.~      Randomised patients whose disease progresses to the next disease level during the 3 year~     treatment period will be unblinded, and open label ramipril treatment will be initiated and~     continued, respectively, depending on prior treatment randomisation.~   "
158918|NCT01485965|"~     The primary purpose of this study is to assess the effect of food upon the pharmacokinetics~     (PK) of SEN0014196 in subjects with Huntington disease (HD).~   "
158919|NCT01485952|"~     The primary objective of this study is to provide biological samples from patients with~     Huntington's disease to allow characterisation of the pharmacological mechanism of action of~     SEN0014196.~   "
158920|NCT01485939|"~     The investigators hypothesized that application of a 5% lidocaine patch would be associated~     with reduced pain scores after operation compared with placebo patch in patients undergoing~     laparoscopic cholecystectomy.~   "
158921|NCT01485926|"~     The primary objective:~      -To assess the efficacy of TCH and TCHL in neo-adjuvant treatment of HER-2 positive breast~     cancer, using pathological complete response (pCR) as the primary endpoint (Phase II).~      Secondary objectives:~        -  To assess the clinical response rate and overall response rate for docetaxel and~          carboplatin with trastuzumab alone or trastuzumab combined with lapatinib in HER-2~          positive breast cancer.~        -  To assess the relationship between drug exposure and adverse events.~        -  To examine potential molecular and pharmacological markers of response to trastuzumab~          and lapatinib~        -  To assess Disease-free Survival (DFS) and Overall Survival (OS)~        -  To determine if prophylactic Loperamide significantly reduces the number of diarrhoea~          -related adverse events.~   "
158922|NCT01485913|"~     The project will test the implementation of a specific methodology for education of type 2~     diabetic patients that will be set up using patients involved (peer educators) and 3 guides~     developed specifically for the therapeutic education of type 2 diabetic patients. This~     project will take place in 1 sites in mali : the capital Bamako. 75 diabetic patients will be~     subjected to intervention with this methodology and 75 other diabetic patients will be the~     control group. At various stages of the project, the investigators will analyze the impact on~     biological, anthropological constants, etc ... of the group undergoing the intervention~     compared to the control group.~   "
158923|NCT01485900|"~     Primary Objective:~        -  To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in~          patients with moderate chronic kidney disease (CKD) on stable angiotensin converting~          enzyme-inhibitor (ACE-I)~      Secondary Objectives:~        -  To assess in patients with moderate CKD the effect of concomitant multiple dose of~          SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate~        -  The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to~          ACE-Is (AcSDKP)~        -  The pharmacokinetic profile of repeated oral administration of SAR407899A during~          co-administration of ACE-Is~   "
158924|NCT01485887|"~     This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete~     the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate~     in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase.~     The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication~     dosing.~   "
158925|NCT01485874|"~     The purpose of this trial is to determine whether BIBF 1120 can be safely combined with~     pegylated liposomal doxorubicin (phase I), and to determine the clinical activity of the~     combination in patients with platinum-resistant ovarian cancer (phase II).~   "
158926|NCT01485861|"~     This multicenter, international, Phase Ib/II trial consists of two stages: a Phase Ib,~     open-label stage in which the recommended Phase II dose will be determined for ipatasertib~     and apitolisib in combination with abiraterone and prednisone/prednisolone and a Phase II,~     3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and~     prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone.~   "
158927|NCT01485848|"~     Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial~     benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare~     the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in~     patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any~     significant changes in the safety profile of weekly paclitaxel alone compared to the doublet~     combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this~     new drug combination.~   "
158928|NCT01485835|"~     The purpose of this study is to find out what effects, good and/or bad, that ganetespib and~     bortezomib has on you and your cancer. The investigators will determine the side effects of~     different dose levels of ganetespib when given alone and the effect it has on your cancer~     alone. The investigators will also determine the side effects of ganetespib at different dose~     levels when given in combination with bortezomib and the effect the combination has on your~     cancer. The study will measure levels of the drug in your blood and bone marrow as well.~      Bortezomib is a proteasome inhibitor that is approved by the US Food and Drug Administration~     (FDA) that is used for the treatment of multiple myeloma. The brand name for bortezomib is~     Velcade®.~      Ganetespib is considered investigational because it has not received approval from the Food~     and Drug Administration for general use, although it has been previously tested in humans.~   "
158929|NCT01485822|"~     The purpose of this study was to assess the pigmentation in the trabecular meshwork of~     patients who had been treated for at least 2 years with TRAVATAN compared with patients~     without exposure (or less than 1 month) to a prostaglandin analogue (PGA).~   "
158930|NCT01485809|"~     Gefitinib was the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI)~     approved for the treatment of advanced non-small cell lung cancer (NSCLC). Results from two~     randomised phase II trials (IDEAL 1 and 2) suggested that gefitinib was efficacious and less~     toxic, compared with previous results, than was chemotherapy in patients with~     previously-treated non-small-cell lung cancer. Two phase III trials of gefitinib in advanced~     non-small-cell lung cancer followed on from the IDEAL phase II studies: Iressa Survival~     Evaluation in Lung cancer (ISEL) and Iressa NSCLC Trial Evaluating REsponse and Survival~     versus Taxotere (INTEREST). Although the phase III ISEL trial failed to prove the superiority~     of gefitinib treatment compared to placebo in previously treated patients, a subgroup~     analysis demonstrated improved survival in particular populations (Asians and non-smokers).~     The INTEREST study compared an EGFR tyrosine kinase inhibitor with chemotherapy in pretreated~     advanced non-small-cell lung cancer. In INTEREST, survival was similar for gefitinib and~     docetaxel in almost all subgroups; no EGFR-related biomarker or any clinical factor~     (including female sex, adenocarcinoma histology, never-smoker, and Asian ethnicity) appeared~     to be predictive of a greater survival benefit for gefitinib versus docetaxel. However, these~     factors may still be predictive of a greater survival benefit for gefitinib and/or docetaxel~     versus best supportive care; alternatively, they may just be good prognostic factors.~     Progression free survival and overall response rate was no statistically significant~     difference between gefitinib and docetaxel. This suggests gefitinib can provide similar~     overall survival to docetaxel in pretreated advanced non-small-cell lung cancer patients.~     These studies have demonstrated that gefitinib is effective for the second-line treatment of~     NSCLC. Now, gefitinib is recommended in advanced and metastatic NSCLC as second-line~     chemotherapy.~      But, there was no prospective study with gefitinib in NSCLC wih squamous cell histology. This~     trial will investigate the efficacy and safety of gefitinib in locally advanced, metastatic~     NSCLC patients with squamous cell histology who have failed first-line chemotherapy.~   "
158931|NCT01485796|"~     The purpose of the study is to acquire additional data on safety and tolerability of~     recombinant human hyaluronidase (rHuPH20) facilitated subcutaneous treatment of Immune~     Globulin Infusion (Human), 10% (IGI, 10%) and to assess the mode of product administration.~      Following a discussion with the FDA at the end of July 2012, all participants still active in~     the study stopped treatment with rHuPH20 to assure safety of the participants participating~     in the study and went into a safety follow-up.~      During this safety follow-up period, participants underwent treatment with the licensed~     product IGI, 10% (Gammagard Liquid). The intravenous or subcutaneous administration route was~     at the discretion of the participant and the investigator.~   "
158932|NCT01485783|"~     Approximately 200 children age 6 - <18 years receiving medications for essential hypertension~     (HTN) will be recruited from the Pediatric Hypertension Clinic at the time of a routine~     clinic visit. Participating subjects will be asked to wear the ambulatory blood pressure~     monitor (ABPM) for 24 hours within 2 weeks of the qualifying visit. Measurements obtained~     with the ABPM will be compared to measurements obtained by routine clinical procedures~     documented in the subject's clinical chart. Kappa statistic will be utilized to compare~     differences in documented BP control between the two measures as well as changes in~     therapeutic management decisions by treating physicians with the addition of the ABPM~     readings. The overall goal is to confirm that ABPM leads to an increased detection of~     uncontrolled HTN along with a similar increase in adjustments increasing anti-hypertensive~     medication regimens.~   "
158933|NCT01485770|"~     This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in~     the treatment of excessive daytime sleepiness in adults with narcolepsy.~   "
158934|NCT01485757|"~     HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and~     exercise tolerance will be abnormal in the population of young heart transplant patients at~     baseline, and that each will show a trend towards improvement following a 12 week course of~     oral L-arginine, with regression towards the baseline following the 12 week washout period.~   "
158935|NCT01485744|"~     LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade~     of molecular events that control cell growth and have been linked with the development of~     many human cancers, including pancreatic cancer. Information from research studies suggests~     that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In~     this research study, the investigators are looking to determine the maximum dose of LDE225 in~     combination that can be given safely to patients with locally advanced or metastatic~     pancreatic cancer.~   "
158936|NCT01485731|"~     Nelfinavir will increase the efficacy of Cisplatin based chemo- radiation therapy for locally~     advanced cervical cancer.~   "
159021|NCT01484626|"~     The purpose of the study is to determine the safety and efficacy of the use of Bendamustine~     in combination with a commonly used combination chemotherapy to treat relapsed and refractory~     multiple myeloma. The study will be conducted in two phases. Participants in phase I will~     receive 1 of 4 escalating doses of bendamustine. Once the maximum tolerated dose of~     bendamustine is determined phase II of this trial will begin. Participants in phase II will~     receive the maximum tolerated dose of bendamustine in combination with standard of care~     chemotherapy.~   "
158937|NCT01485718|"~     Glucomannan is a dietary supplement that has been marketed for weight loss. There is some~     research that supports this claim but more research is necessary. This is research study is~     being conducted to determine if the dietary supplement glucomannan is effective for weight~     loss in adults greater than 18 years of age who are overweight.~      Participants will be randomized in a 1:1 manner (like the flip of a coin) to receive either~     glucomannan 575 milligrams, 2 capsules three times daily or placebo, 2 capsules three times~     daily. The study will last for 12 weeks.~      At the start of the study participants will be asked questions about current medications and~     diet/exercise regimen, a weight and height will be obtained, and they will be given a~     one-month's supply of study supplement. An investigator will call each participant after they~     have been taking the supplement for 2 weeks to ensure that the participant is tolerating the~     supplement and answer any questions. Throughout the study, participants will be required to~     follow-up with investigators in the office every 4 weeks (a total of 3 follow-up~     appointments). Every 4 weeks, the investigators will weigh participants, count the leftover~     capsules from the previous month, and ask about any adverse effects you may be experiencing.~     At the conclusion of the study, a final weight will be compared with the baseline weight to~     determine if the medication had an effect on weight loss.~   "
158938|NCT01485705|"~     The aim of the study is to determine the frequency of sub-optimal care in the initial care~     (before arrival at the intensive care unit) of children from West France regions suffering~     of severe bacterial infections.The characteristic optimal or not of the initial medical~     care will be determined by 2 independent experts, blinded from each other and blinded from~     the issue of the care. In case of a discordance between the two experts, a third expert will~     be demanded. Three possibilities of conclusion will be proposed to the experts: sure~     sub-optimal medical care, possible suboptimal care and optimal care.~   "
158939|NCT01485692|"~     This study aims to evaluate the efficacy and safety of four options of medications in the~     management of acute psychomotor agitation,or violence and aggression situations in health~     services. All of the treatment options are already approved and currently used for this~     purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine,~     olanzapine and ziprasidone. The investigators hypothesized that all treatment options are~     effective in the treatment of acute agitation, but the combination haloperidol plus~     promethazine could elicit more adverse affects than the others.~   "
158940|NCT01485679|"~     The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in~     identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will~     be compared to those obtained by the pathological analysis of the removed piece of pancreas.~   "
158941|NCT01485666|"~     The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management~     Kit for HeartMate II driveline stabilization and exit site management.~   "
158942|NCT01485653|"~     The use of ultrasonography as an adjunct to regional anesthesia has significantly increased~     in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of~     ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution~     of the block solution. When compared to other methods of nerve localization, sonography~     decreases: failure rate procedure time and the onset time for blockade. Furthermore, the use~     of ultrasound for peripheral nerve blockade demonstrates decreased procedure related~     complications such as nerve injury and unintentional vascular puncture.~      Traditional axillary block techniques relying on surface anatomical landmarks require large~     volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy~     offered by ultrasound, some studies have shown that low volumes of local anesthetic can yield~     successful axillary plexus blockade. Therefore, the tradition of using large volumes of local~     anesthetic for axillary blocks, even without ultrasound, may not be warranted.~      Although recent investigations support using a low volume of local anesthetic for brachial~     plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary~     objective of this study was to evaluate 2 different volumes of local anesthetic for axillary~     blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5%~     solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks,~     which is secondary to: rapid onset of action, intermediate duration of effect, and relative~     low cost. The primary outcome was block success rate for outpatients undergoing distal upper~     limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time~     required to perform the block, and onset of sensory and motor blockade.~   "
158943|NCT01485640|"~     This is an open-label continuation study designed to monitor the safety, tolerability and~     effectiveness of lurasidone in subjects who have completed participation in a lurasidone~     extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment~     with lurasidone.~   "
158944|NCT01485627|"~     The purpose of this study is to determine whether a combined intervention for patients,~     caregivers and oncologists improves communication, quality of life, and quality of care.~   "
158945|NCT01485614|"~     The purpose of the study is to assess the safety of the addition of sitagliptin, and its~     effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2~     diabetes mellitus (T2DM) with inadequate glycemic control. The primary hypothesis for this~     study is that sitagliptin reduces A1C more than placebo after 20 weeks of treatment.~   "
158946|NCT01485601|"~     The purpose of this study is to find an optimal dose to determine the safety and tolerability~     of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular~     injection in subjects with glabellar lines compared with the standard dose of BOTOX®~   "
158947|NCT01485588|"~     Phase 1: The purpose of this study is to evaluate the safety and tolerability of single~     ascending doses of hI-con1™ for subjects with Age-Related Macular Degeneration.~      Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1™ at 2~     different dose levels.~   "
158948|NCT01485575|"~     Intravitreal dyes are intended to make the surgical extraction of the Internal limiting~     membrane (ILM) safer and more complete. However, the search for an adequate vitaly dye is~     ongoing. The most commonly used vital dye is Indocyanine green (ICG), although it is not~     approved for intravitreal use and has been associated with ocular toxicity. The reason for~     its continued popularity seems to be that it stains the ILM better than the approved and less~     toxic alternative substances Brilliant Blue G (BBG) and Trypan blue (TB). According to~     anecdotal reports from surgeons, another reason for ICGs popularity may be the fact that it~     seems to make ILM removal easier. Ultimately, the intention of the investigators research is~     to identify possible modifications to existing dyes to reach improved intraoperative dye~     utility combined with a favorable safety profile.~      Protocol was amended and approved concerning additional use of basal membrane of deceased~     donors.~   "
158949|NCT01485562|"~     A double-blind individual randomized controlled study of misoprostol vs. placebo for~     treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in~     Pakistan.~   "
158952|NCT01485523|"~     The diagnosis of allergic rhinitis to dust mites is difficult and based on three elements :~     suggestive symptoms of clinical sensitization to dust mites (rhinitis), the existence of an~     IgE sensitization defined by skin tests and / or specific IgE positive to mite and finally~     the presence of mite allergens in the environment where the patient is symptomatic.~     Unfortunately, the link between symptoms and exposure to dust mites is rarely found and~     according to in the literature, 30% of rhinitis sensitized to house dust mites did not react~     during a conventional nasal provocation test (TPNC) to dust mites. Thus, TPNC to dust mite~     has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a~     doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or~     the variability of the allergic symptoms during the year. However, this test has not been~     completely validated with a study including a significant number of patients. That's why the~     investigators plan a prospective single-center comparative open study with the main objective~     is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC)~     in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and~     patients with allergic rhinitis not sensitized to dust mites. The investigators secondary~     objective is to compare the TPNC a faster TPN-called minute (60 minutes) and which allow a~     wider use. If the investigators demonstrate the validity of TPN then it would become the gold~     standard needed to decide on a desensitisation to mites.~   "
158953|NCT01485510|"~     Early intervention for maltreated infants can improve mental and physical health throughout~     life and benefit families and society as a whole. The New Orleans Model provides intensive~     assessment and treatment for families of maltreated preschool children in foster care, with~     recommendations to court about adoption, or permanent return to birth families. The New~     Orleans Model appears to have led to better informed decisions about permanent placement and~     to better child mental health in Louisiana. The investigators propose an exploratory~     randomised controlled trial investigating the effectiveness of the New Orleans Model in the~     Scottish context, informing the development of an economic model to explore the potential~     cost-effectiveness. Families with a maltreated child under 5 years of age will be offered the~     New Orleans Model or case management i.e. quality assured services as usual, using random~     allocation. The investigators will measure outcome using well validated measures of~     parent-child interaction, cognition and attachment.~   "
158954|NCT01485497|"~     The purpose of this study is to determine whether the Optical coherence tomography (OCT) can~     image the structure and geometry of hollow organs of the upper airway in sleep disorder. The~     research can identify the obstruction sites that help the select the appropriate treatment~     for potential surgical candidates.~   "
158955|NCT01485484|"~     The research at University of California Irvine, Beckman laser institute and Praxis~     Biosciences Incorporation, develope near-infrared trans-illumination methods. The optical~     imaging tool that can determine acute sinusitis and the response to treatment therapy.~   "
158956|NCT01485471|"~     Otitis media is more common in young children and it is estimated that 75% of all children~     experience at least one episode before the age of three. Otitis media is one of the common~     pediatric diagnoses and recurrent episodes account for the most commonly performed surgical~     procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition~     which depends on subjective assessment of the ear drum via direct visualization using an~     otoscope. Researcher can use Diffuse optical spectroscopy and diffuse optical imaging for the~     analysis of ear drum and the middle ear.~   "
158957|NCT01485458|"~     Controversy exists regarding the optimal management of acute traumatic cervical spinal cord~     injury (SCI), especially those without bone injury. Although surgical decompression is often~     performed in SCI patients with cervical canal stenosis, efficacy and timing of surgery~     continues to be a subject of intense debate. In this randomized controlled trial, the~     investigators compare two strategies: early surgery within 24 hours after admission and~     delayed surgery following at least 2 weeks of conservative treatment. The purpose of this~     study is to examine whether early surgery would result in greater improvement in motor~     function as compared with delayed surgery.~   "
158958|NCT01485445|"~     The purpose of this study is to determine the bioequivalence of fluticasone furoate (FF)~     inhalation powder (single strip configuration) compared with FF inhalation powder (two strip~     configuration) and compared with FF / vilanterol (VI) inhalation powder. Fluticasone furoate~     (FF), is being developed both as a monotherapy for the treatment of asthma and in combination~     with vilanterol (VI) for the treatment of asthma and Chronic Obstructive Pulmonary Disease~     (COPD). Thirty healthy male and female subjects will be enrolled in the study to ensure~     twenty-four evaluable subjects.~   "
158959|NCT01485432|"~     This study is designed to compare the incidence of delayed graft function in patients~     following renal transplant surgery with different perioperative hemodynamic managements: a~     goal directed hemodynamic management group (using PiCCO) and a control group.~   "
158960|NCT01485419|"~     Traumatic injury is a major public health problem with an immense societal cost. Despite~     improvements in trauma management, patients continue to suffer significant morbidity and~     mortality. Evidence suggests that males and females tolerate severe injury differently with a~     greater protection afforded to females. Determining the mechanisms responsible for these~     sex-based outcome differences after injury, focusing specifically on the early sex-hormone~     environment post-injury, may allow those at highest risk for poor outcome to be predicted and~     promote interventions that can improve outcomes for all injured patients. The goal of this~     study is to determine if the early sex hormone environment soon after injury has effects on~     the intensity of the immune response, resuscitation and blood transfusion requirements, and~     important clinical outcomes including mortality, organ failure and infection, following~     significant injury.~   "
158961|NCT01485406|"~     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the~     GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study~     entry.~   "
158962|NCT01485393|"~     The purpose of this study is to determine whether dexmedetomidine can be used to induce~     normal physiological sleep in humans.~   "
158963|NCT01485380|"~     The investigators are doing this research study to find out how and where dexmedetomidine, a~     sedative anesthetic, acts in the brain. The investigators will do this by using a machine~     that records the brains electrical activity, called an electroencephalogram (EEG), and brain~     imaging scans to look at the brain.~   "
158966|NCT01485341|"~     The idea is to evaluate if the so called Gluten Sensitivity is a real clinical entity.~     Gluten sensitive (GS) persons are defined as those patients, being neither celiac or allergic~     to weat, who develop symptoms following gluten consumption. This will be achieved by~     evaluating a global symptom score in GS patients receiving gluten compared to those receiving~     placebo (primary end point). Symptoms to be evaluated: gastrointestinal (Gastrointestinal~     Symptom Rating Scale, GSRS); not-gastrointestinal (specifically built evaluation scale); VQV~     scale, built to evaluate quality of life. Gluten or placebo will be administered daily (10 g)~     for 15 days; for the 15 days before and 15 after all patients will stay on Gluten Free Diet~     (GFD). Besides clinical evaluation (each week for 6 weeks), intestinal permeability testing~     and blood sampling will be requested for the identification of possible markers (serological,~     gut barrier function, immunological and expression of tight junctions constitutive proteins)~     that may be of help to differentiate the condition of gluten sensitivity (GS) from that of~     Celiac Disease (CD)(secondary end point). Inclusion and exclusion criteria for patients~     enrolling are strictly dependant on the given Gluten sensitivity definition. We expect to~     experience a worsening of gastrointestinal and extra-gastrointestinal symptoms, from hours to~     days, with an increase in the overall symptom score, above the cut off, in at least 45% of GS~     subjects enrolled and that have received gluten compared to GS who received placebo.~   "
158967|NCT01485328|"~     This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic~     digestive complaints.~   "
158968|NCT01485315|"~     Patients with blood poisoning - sepsis - often receive blood transfusions in the intensive~     care unit. The evidence that blood transfusion leads to improved outcome is limited and the~     blood may be harmful to some of these patients. To bridge the gap between clinical practice~     and evidence, a large randomised clinical trial is needed to document the efficacy and safety~     of RBC transfusion in these very sick patients~   "
158969|NCT01485302|"~     Primary Objective:~      - To assess the safety and tolerability of escalating single and multiple doses of SAR228810~     in patients with Alzheimer's disease (AD)~      Secondary Objective:~      - To evaluate the pharmacokinetic properties of SAR228810 after escalating single and~     multiple doses of SAR228810 in AD patients~   "
158970|NCT01485289|"~     The intent of this study is to complete the collection of clinical data on subjects enrolled~     in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the~     now defunct Applied Spine Technologies Inc . The Applied Spine assets, including the clinical~     trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased their funding~     of the trial, a number of enrolled patients had not yet completed the two year follow-up~     visit defined as the study endpoint in the clinical investigation plan. No additional patient~     treatment is required to complete the study. Rachiotek has interest in pursuing IDE approval~     for a new study and the information collected in this study is essential for supporting the~     new Investigational Device Exemption application.~   "
158971|NCT01485276|"~     Background:~      - Deep brain stimulation (DBS) in the subthalamic nucleus (STN) is an approved treatment for~     Parkinson s disease. It stimulates a part of the brain that helps control symptoms like~     tremor, stiffness, and slow movements. However, many people continue to have unsteadiness and~     slowness while walking, trouble swallowing, and speech problems even with STN DBS. Another~     type of DBS focuses on a part of the brain called the pedunculopontine nucleus (PPN). PPN DBS~     has improved walking in some people with Parkinson's disease. Researchers want to see if~     combining the two types of DBS may help control symptoms better than STN DBS alone.~      Objectives:~        -  To see if PPN DBS can help walking, balance, speaking, and swallowing in those who~          already have STN DBS.~        -  To study how the DBS combination affects brain function.~      Eligibility:~      - Individuals with Parkinson s disease who had STN DBS surgery at least 1 year ago, but still~     have difficulty walking, swallowing, and speaking.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have neurological tests and other tests to measure Parkinson s disease symptoms.~        -  This study requires eight visits over 1 year. One of the visits will be a 9- to 10-day~          admission to the NIH Clinical Center for DBS surgery.~        -  Participants will have PPN DBS surgery. The surgery will be done in two steps. In the~          first step, the leads will be placed in the brain. In the second step, 1 week later, the~          stimulator device will be placed in the chest or abdomen.~        -  One month after the surgery, participants will have a study visit to program the PPN DBS~          device to find settings that will improve walking and balance.~        -  Participants will have study visits 2, 3, 6, and 12 months after surgery. Each visit~          will be used to check the stimulators and make any adjustments needed to try to improve~          walking and balance or to lessen side effects. Participants will have tests of walking~          and balance, speech, and swallowing. Some tests will be done with different combinations~          of the stimulators on or off to see the effects of each set of stimulators....~   "
158972|NCT01485263|"~     Objective~      The objective of this pilot study is to characterize the abnormal neuronal firing patterns of~     basal ganglia neurons and those in the premotor cortex in patients with treatment-resistant~     movement disorders undergoing deep brain stimulation (DBS) surgery.~      Study population~      Fifteen adult patients with treatment-resistant movement disorders who are undergoing deep~     brain stimulation surgery at Suburban Hospital, Bethesda, Maryland, will be studied.~      Design~      This is a physiology study of treatment-resistant movement disorder patients who have been~     scheduled for implantation of a deep brain stimulation device into the Nucleus accumbens.~     Prior to surgery, patients will learn a rewarded visual-motor task and undergo~     magnetoencephalography. The task will be repeated during DBS surgery, with collection of~     information on electrical activity including single neuronal unit and local field potentials.~     The task and MEG will be repeated 3-4 months after surgery. The collected data will be~     analyzed for coherence patterns during rest and rewarded movements.~      Outcome measures~      We plan to characterize and quantify the oscillatory activity present in motor circuits of~     treatment-resistant movement disorder patients during rewarded visually guided movements. We~     hypothesize that during visually guided movements, neuronal coherence will be significantly~     increased relative to resting periods. Thus, by better understanding the alteration in~     oscillatory patterns in these patients, we hope to develop better DBS stimulation paradigms~     in order to better treat this disease in the future.~   "
159022|NCT01484613|"~     Cardiac resynchronization (CRT) therapy is well established for treatment of patients with~     severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony.~     Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is~     interruption of biventricular pacing. This might be caused by several conditions, including~     elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation~     (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's~     the aim of this prospective observational study to investigate efficacy and reliability of~     cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.~      Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead,~     at least one acceptable LV lead vector is available.~   "
159023|NCT01484600|"~     This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668~     Administered Subcutaneously to Healthy Volunteers.~   "
158973|NCT01485250|"~     Background:~        -  Individuals often participate in clinical trials to seek new therapies and free medical~          treatments for their illnesses or chronic conditions. However, less is known about the~          motivations of the healthy individuals who volunteer for research studies.~        -  Although many healthy volunteers participate in clinical trials for financial~          compensation, the particular risks involved in testing drugs that have not been tried in~          human clinical trials pose potential dangers for healthy volunteers in Phase I studies.~          More research is needed to understand the motivations of volunteers who participate in~          Phase I clinical trials.~      Objectives:~      - To evaluate the primary and secondary motivations of healthy participants in research~     studies.~      Eligibility:~      - Individuals at least 18 years of age who are healthy volunteers in selected Pfizer Phase I~     clinical trials.~      Design:~        -  Individuals who express interest in participating in specific Pfizer Phase I drug~          studies will be asked to complete a short questionnaire after completing the standard~          consent session for the study.~        -  Those who enroll in the trial will be asked to complete a second questionnaire prior to~          discharge from the study.~   "
158974|NCT01485237|"~     The main purpose of this study is to review the resource utilization of severe adult H1N1~     pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with~     pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg.~     Secondary objectives include, comparison of resource utilization to other similar disorders~     (viral pneumonia, bacterial pneumonia, septic shock, ARDS). The investigators will also look~     at the percentage of patients that required ICU care as compared to those who could be cared~     for on medical wards. The investigators will determine the resources used by both groups and~     compare. Finally the investigators will record the frequency of chronic comorbidities in~     hospitalized adult H1N1 patients.~   "
158975|NCT01485224|"~     Hereditary hemorrhagic telangiectasia (HHT) (OMIM 187300 and 600376), also known as~     Rendu-Osler-Weber syndrome, is an autosomal dominant disease and has a prevalence between~     1:5000 and 1:8000 in different populations. Clinically, the occurrence of mucocutaneous and~     gastrointestinal telangiectasias and of systemic arteriovenous malformations is commonly~     observed. Recurrent and severe epistaxis, due to the presence of telangiectasias in nasal~     mucosa, is the most common presentation of HHT, frequently leading to severe anemia requiring~     intravenous iron and blood transfusions. Although not life threatening, severe epistaxis has~     a great impact on quality of life in HHT patients and it represents the most important~     impediment in daily activities, that poses therapeutic challenge. Recently, angiogenesis has~     been implicated in the pathogenesis of HHT. Circulating concentrations of both TGF-beta and~     vascular endothelial growth factor (VEGF) are significantly elevated and therefore,~     anti-angiogenic substances may be effective in the treatment of vascular malformations in~     this disease. Thalidomide functions as a potent immunosuppressive and antiangiogenic agent.~     The aim of this study is to assess the clinical effects of thalidomide therapy on the~     severity of epistaxis in subjects with HHT who are refractory to standard therapies.~   "
158976|NCT01485211|"~     The purpose of this study is to evaluate the corneal pachymetric variations during and after~     corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and~     hypo-osmolar riboflavin solution in thin corneas.~   "
158977|NCT01485198|"~     Patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria will~     be allocated into two groups:~        -  The control group will receive Acetaminophen 750mg orally every 8 hours~        -  The experimental group will receive Autologous Hematopoietic Stem Cells from bone marrow~          (BMASC)~      Signed informed consent is required, as well as answering a questionnaire.~      Patients in experimental group will receive subcutaneous G-CSF (10ug/kg/day) for 3~     consecutive days and, on the 4th day a bone marrow harvest under general sedation will be~     performed from posterior iliac crests. The patient will remain in the recovery room while the~     cells are processed at the Hematology Service Laboratory. Finally, BMASC will be infused to~     the joint under local anesthesia.~      The procedure is ambulatory.~   "
158978|NCT01485185|"~     This study will compare the effects of gabapentin alone, and gabapentin + donepezil given~     together in two types of experimental electrical pain tests in up to 48 healthy male subjects~     (after 24 recruited in the first cohort an interim analysis will be performed).~      The study is a randomized, double blind, placebo controlled, 3 was cross-over design study~     with incomplete block design and 4 treatment options. Placebo, gabapentin alone (lower dose~     and higher dose) or gabapentin (lower dose) with donepezil.~   "
158979|NCT01485172|"~     This study is a fixed dose, dose response study to characterize the dose response for~     ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and~     baseline assessments, subjects will be randomized to one of six final target treatment groups~     (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening~     period, an up-titration period, a maintenance period, a down titration period and a follow up~     period. This study utilizes change from baseline in the UPDRS motor score as the primary~     endpoint, in line with that used in the ropinirole PR monotherapy pivotal study~     (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in~     order to establish the lowest maximally effective therapeutic dose.~   "
158980|NCT01485159|"~     This is a cross-sectional, observational study, investigating the point prevalence of Airflow~     Limitation in current or former smokers with established ischemic heart disease. The study~     will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.~   "
158981|NCT01485146|"~     This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy~     subjects.~   "
159024|NCT01484587|"~     The purpose of this study is to assess the safety and tolerability of CNTO 1959 following a~     single subcutaneous (SC, under the skin) dose administered to Japanese participants with~     moderate to severe plaque psoriasis.~   "
159025|NCT01484574|"~     This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy~     of different doses of Stempeucel in critical limb ischemia patients.~   "
159026|NCT01484561|"~     The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of~     kidney function in patients with active rheumatoid arthritis (RA).~   "
159525|NCT01478048|"~     The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/~     Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)].~   "
158982|NCT01485133|"~     Water method with water exchange has been shown to reduce medication requirement and pain~     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated~     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope~     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion~     of air from the colon during insertion by omission of air insufflations and suction removal~     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy~     insertion in average patients and may enhance the success of difficult colonoscopy.~      Prior abdominal or pelvic surgery is an independent factor for difficult colonoscopy, the~     probable adhesion may change the anatomy and increase the discomfort of patients. We~     postulate that these patients may benefit from using the water method for colonoscopy. In~     this proposal we test the hypothesis that compared with conventional air insufflations the~     water method with water exchange significantly enhances the success rate of cecal intubation~     in patients with prior abdominal or pelvic surgery.~      The aim of the study is to compare the outcome of colonoscopy using the water method versus~     the conventional air method in patients with prior abdominal or pelvic surgery. The primary~     outcome is cecal intubation success rate. The secondary outcomes include cecal intubation~     time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma~     detection rate.~   "
158983|NCT01485120|"~     The purpose of this study is to establish the performance of a blood pressure cuff. The~     hypothesis is that the blood pressure reading from the cuff will provide similar blood~     pressure as a radial artery.~   "
158984|NCT01485107|"~     Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using~     the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days~     post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and~     tighten the skin of the décolleté region.~   "
158985|NCT01485094|"~     The purpose of this trial is to determine whether a novel analgesic is effective in treating~     of neuropathic pain caused by herpetic infection, surgery, or trauma.~   "
158986|NCT01485081|"~     The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel~     Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native~     coronary arteries.~   "
158987|NCT01485068|"~     The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting~     Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.~   "
158988|NCT01485055|"~     Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common~     development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells~     attack and damage your tissues and organs after transplant.~      Acute GVHD often causes: Skin rashes, nausea, vomiting, abdominal pain, diarrhea (may have~     blood), liver damage that can cause inflammation in the liver or jaundice (yellowing of the~     skin or eyes), damage to other organs~      Steroids are the first line of treatment for acute GVHD. About a quarter of the patients that~     develop acute GVHD may not respond to steroid and have steroid refractory GVHD (SR-aGVHD).~     Patients with SR-aGVHD may need other medications. SR-aGVHD, is a potentially life~     threatening condition. There is no standard treatment and it may not respond to treatment.~      The goals of this study are to find out if Infliximab and basiliximab can treat SR-aGVHD.~      Participants in this study will receive combination therapy (2 drugs: infliximab and~     basiliximab) once a week for four weeks.~   "
158989|NCT01485042|"~     3 STUDY RATIONALE Based upon the above rationale, the investigators propose a phase I study~     combining Pazopanib with TH-302 in advanced solid tumors. Pazopanib is FDA approved at a dose~     of 800mg per day. Using this dose ensures consistency with standard clinical use. It also~     ensures using the dose most likely to induce maximal hypoxia, which in turn will help ensure~     maximal local activation of TH-302 (a hypoxia activated prodrug). TH-302 can be given as~     monotherapy at a weekly dose of 575 mg/m2. When TH-302 is combined with full doses of various~     chemotherapeutics, the recommended dose of TH-302 has ranged from 240 to 480 mg/m2. Little~     overlapping toxicity between TH-302 and pazopanib is expected. However to ensure patient~     safety, the starting dose for the combination will be conservative and use the TH-302 dose~     found safe with the majority of cytotoxic agents, 340 mg/m2 given days 1,8, 15 on an every 28~     day cycle.~      Using a standard 3+3 design, the investigators will add increasing doses of TH-302 (340~     mg/m2, 480 mg/m2, 575 mg/m2 given weekly, 3 weeks on/1 week off (the standard TH-302 dosing~     schedule) to the full monotherapy dose of pazopanib (800 mg p.o daily) with expected accrual~     ranging from 12-18 subjects. Once the recommended phase II dose is identified, the~     investigators will then enroll an expanded cohort of approximately 12-18 (i.e. total of 30~     subjects overall) patients to better define the tolerability of this study drug combination.~      4 STUDY OBJECTIVES 4.1 Primary~        -  To define the maximal tolerated dose (if any) and the recommended phase II doses for the~          combination of pazopanib plus TH-302 in patients with advanced solid tumors 4.2~          Secondary~        -  To describe any dose limiting and non dose-limiting toxicities of this drug combination~   "
158990|NCT01485029|"~     Antibiotic consumption and antimicrobial resistance remain notoriously high in France,~     particularly among children below three years of age. In France, the pneumococcal conjugate~     vaccine was officially recommended for all children under two in 2003, and consequently~     changes occurred in Streptococcus pneumoniae serotype distribution. Bacterial carriage among~     children attending day-care centres may result from vaccine- and antibiotic-driven selective~     pressure with possible repercussions on the community.~   "
158991|NCT01485016|"~     The purpose of this study is to gather changes in physiological and biomechanical data during~     daily activity and sleep in epilepsy subjects.~   "
159027|NCT01484548|"~     The purpose of this study is to determine the safety, tolerability, and immunogenicity in~     healthy adult subjects of an investigational vaccine being developed for the prophylaxis of~     visceral leishmaniasis. The vaccine, identified as LEISH-F3 + GLA-SE, consists of the~     recombinant two-antigen Leishmania recombinant protein LEISH-F3 together with the adjuvant~     GLA-SE.~   "
159028|NCT01484535|"~     This trial will study the effect of hematoma aspiration in patients with acute ankle~     fractures.~   "
159061|NCT01484106|"~     The primary objective of this study is to test whether a fluid resuscitation protocol guided~     by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by~     an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in~     sepsis patients presenting to the Emergency Department without evidence of shock.~   "
158992|NCT01485003|"~     The primary objective of the study is to determine which baseline and yearly response factors~     (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24,~     and clinical disease-free status in subsequent Months 36 and 48. The secondary objectives~     are: To identify prognostic factors at Baseline that predict overall disease-free status at~     Month 12, and to assess if yearly overall disease-free response factors predict overall~     disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded~     Disability Status Scale [EDSS]) at each analysis time point of Months 12, 24, 36, and 48; To~     identify prognostic factors at Baseline that predict clinical disease-free status at Month~     12, and to assess yearly clinical disease-free response factors that predict clinical~     disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate~     the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the~     following: annualized relapse rate (ARR), sustained EDSS progression and improvement (24-week~     sustained); To evaluate the impact of Tysabri at each analysis time point of Months 12, 24,~     36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1 with~     Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month 48 on~     the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity~     Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24,~     36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test [SDMT]),~     capacity for work (Work Productivity and Activity Impairment Questionnaire [WPAI]), quality~     of life (QoL) (Multiple Sclerosis Impact Scale [MSIS-29])~   "
158993|NCT01484990|"~     A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced~     Parkinson's Disease.~   "
158994|NCT01484977|"~     The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide~     (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with~     withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects~     not well controlled on their current regimen.~   "
158995|NCT01484964|"~     The purpose of this study is to determine the bioavailability and pharmacokinetics between~     two different formulations of ASP015K tablets and determine the food effect on the absorption~     of the new formulation.~   "
158996|NCT01484951|"~     The purpose of this study was to assess the safety and efficacy of switching to Azarga from~     prior pharmacotherapy in patients with open-angle glaucoma.~   "
158997|NCT01484938|"~     The purpose of this study was to describe mean differences in corneal staining (type and~     area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared~     to Baseline (Day 0).~   "
158998|NCT01484925|"~     This research study hopes to identify new molecular markers in the tissue of Barrett's~     esophagus that will help physicians better understand and manage this condition. Patients~     undergoing an upper endoscopy will be asked to complete a gastroesophageal reflux disease~     (GERD) questionnaire, provide a blood sample and allow additional biopsies to be taken during~     the procedure.~   "
158999|NCT01484912|"~     The objectives of this study are to evaluate the efficacy, pharmacological activities and~     safety of STA-2 in the treatment of chronic stable angina.~   "
159000|NCT01484899|"~     Environmental factors may play a role in the genesis of pulmonary hypertension, especially in~     endothelial dysfunction. One widespread environmental factor associated with systemic~     endothelial dysfunction is cigarette smoke. It may well be that cigarette smoking is not only~     a risk factor for systemic but also for pulmonary vascular diseases and herewith may interact~     with other risk factors such as a genetic background and associated conditions. The existing~     studies which deal with this subject are only small single center case control studies~     providing less data. Therefore a large European multicenter study is necessary.~      The investigators hypothesis are:~        -  a history of tobacco smoke exposure is highly prevalent in patients with PAH compared to~          the unaffected general population.~        -  a history of tobacco smoke exposure is more prevalent in patients with PAH compared to~          CTEPH.~   "
159001|NCT01484886|"~     In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a~     more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and~     possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will~     not affect the cardiac or pulmonary status of the patient.~   "
159002|NCT01484873|"~     The purpose of this study is to determine whether exenatide can cause weight loss in patients~     with a history of craniopharyngioma or other brain lesion.~   "
159003|NCT01484860|"~     This is a phase II study to see how useful study drug AUY922 is in patients with metastatic~     pancreatic cancer who have received or are intolerant to first-line chemotherapy.~      AUY922 is an intravenous drug that blocks a protein called heat shock protein 90 (Hsp90).~     Hsp90 works by keeping a number of other proteins stable and active, including many proteins~     that are involved in tumor growth and death. When Hsp90 is blocked from working, it is~     believed that many of the other proteins that it stabilizes will also be blocked, which will~     cause tumor growth to slow or stop.~      During the study, patients will visit the clinic once a week, every 4 week cycles to receive~     AUY922 intravenously and to have tests and procedures done. As part of the study, archived~     tumor tissue will be collected and patients will be asked to have blood samples taken for~     pharmacokinetic testing. Patients will be invited to take part in an optional banking of~     blood samples for future studies.~      The primary hypothesis of this study is that AUY922 improves disease control rate compared~     with what would be expected from best supportive care.~   "
159004|NCT01484847|"~     This is a study to assess how much of the investigational drug, PF-00298804, is in the blood~     stream over a period of time (called pharmacokinetic tests or PK) in patients with locally~     advanced head and neck squamous cell carcinoma who have a (gastrojejunostomy) feeding tube.~   "
159005|NCT01484834|"~     The goal of this research was to investigate different intervention strategies in the~     workplace and their impact on quality of life of workers from companies in the city of~     Londrina, Parana, Brazil.~      The interventions were composed by exercise in the workplace and educational interventions.~   "
159062|NCT01484093|"~     Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000~     cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being~     done to better understand how to treat MCL.~   "
159006|NCT01484821|"~     Sarcopenia is known to be associated with loss in muscle mass that results from a reduced~     number of muscle fibres, an atrophy of remaining muscle fibres, and an increased infiltration~     of non-contractile tissue (collagen, fat). Accentuated by cancer and treatments, sarcopenia~     impairs muscle function resulting in a higher risk of physical disability and death. The~     commonly used test for sarcopenia screening consists in a DEXA (Dual energy X-ray~     absorptiometry) scan. However, this test can't provide structural muscle information. In~     contrast, the mechanical properties of muscle tissue can be explored using an acoustic~     radiation force impulse (ARFI). The question remains whether muscle sonoelastography using~     ARFI imaging could be helpful for sarcopenia screening.~      For this, volunteers will be recruited in three groups: ≤ 30 years (Gr A) and ≥ 70years, both~     without any serious chronic disease, and patients ≥ 70 years presenting curative cares for~     cancer (Gr C).~      The volunteers belonging to the groups A and B will be followed during one day. The patients~     included in the group C will be followed during 6 months. For this latter group; the first~     visit (t0) will take place before treatment and the second visit will take place 6 months~     later (t6months) Volunteers will have clinical examinations (weight, stature, BMI,~     performance status/ ECOG) and will be evaluated on their nutritional status (MNA-SF, 24h~     dietary recall) and physical capacities (IPAQ, SPPB, lower limb muscle strength, 6-min walk~     test, QLQ-C30 items relative to the fatigue symptom).~   "
159007|NCT01484808|"~     This is a review of previously published data from a large prostate cancer prevention study~     known as REDUCE. It is the investigators intention to review whether prostate specific~     antigen (PSA) velocity (change over time) will predict the presence of prostate cancer and~     its grade and stage (severity).~   "
159008|NCT01484795|"~     Cardiovascular diseases, especially acute myocardial infarction (AMI), represent the major~     cause of mortality and morbidity in the world. The myocardial ischemia is often the~     precipitating cause of pulmonary edema and noninvasive ventilation (NIV) with positive~     pressure has been used as a therapeutic modality.~      Objective: to evaluate the effects of NIV on heart rate variability (HRV) and on ventilatory~     and hemodynamic variables in patients with myocardial infarction.~      Materials and methods: ten patients with acute myocardial infarction, with Killip I~     classification, will use continuous positive airway pressure (CPAP) and Bilevel ventilation~     during 30 minutes, according randomization. Then ventilatory and hemodynamic variables will~     be registered and electrocardiogram signals will be recorded for posterior analyses of HRV.~     Data will be collected before, during and after positive pressure ventilation.~      Statistical Analysis: Data will be compared using One Way Anova Repeated Measures, followed~     by Tukey test.~   "
159009|NCT01484782|"~     The purpose of this study is to evaluate the feasibility of utilizing an interactive voice~     response (IVR) system to supplement hypertension self-management for patients in~     underdeveloped regions in Mexico and Honduras. Weekly disease assessment calls included~     hypertension self-management suggestions and support to patients. The impact on patients'~     blood pressure levels and other secondary outcomes were evaluated.~   "
159010|NCT01484769|"~     Collection of tissues for analysis from patients undergoing elective neck dissection.~      The hypothesis of the study is that specific genetic alterations occur in head and neck~     cancers that have spread to regional and/or distant sites, and these alterations can be~     identified from biopsy specimens to allow more accurate staging of tumor and better treatment~     planning.~   "
159011|NCT01484756|"~     Nutrient deficiency and immune dysfunction in older persons result in high prevalence of~     acute respiratory infection,which can lead to impaired nutritional status. The study~     objective was to determine the effect of multi micro-nutrient supplementation on nutritional~     and upper respiratory infection among apparently healthy community-dwelling elderly. The main~     hypothesis was whether daily multi micro-nutrient supplementation could reduce the incidence~     and prevalence of upper respiratory infection among apparently healthy community-dwelling~     older persons. Inclusion criteria were apparently independent healthy male and female older~     persons aged 60 years and over, not taking multi micro-nutrient supplementation over the last~     month. The study design was a community-based double-blind controlled trial involving 296~     community-dwelling older persons aged 60 and above, in the Mampang Prapatan district, South~     Jakarta. Participants were randomized to receive either 40 mg elemental zinc (as gluconate),~     120 mg ascorbic acid, 6 mg B-carotene, 15 mg alpha tocopherol (as d-alpha-tocopheryl acid~     succinate) and 400 micrograms folic acid (intervention group) or 400 mg calcium carbonate~     (control group). Supplements were taken daily for six months, from August 2008 to March 2009.~     Nutritional and health status were measured before and after supplementation. Poisson~     regression analysis was used to evaluate the effects of daily multi micro-nutrient~     supplementation on the incidence and prevalence of upper respiratory infection.~   "
159012|NCT01484743|"~     The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters.~     The aim of present study is to use large-scale data from DVHD to uncover risk factors for~     readmission, reoperation (any indication), death and reoperation for recurrence after~     parastomal hernia repair.~   "
159013|NCT01484730|"~     The purpose of this research is to evaluate and validate the performance of non-invasive~     imaging modalities for assessment of skin. A pressure cuff occlusion will be used to~     stimulate blood flow dynamic that these instruments are designed to sense. The researcher~     currently plan to assess only basic feasibility of the imaging instruments.~   "
159029|NCT01484522|"~     The purpose of this research study is to evaluate the immune response to the H1N1 influenza~     or flu vaccine. The immune response is how your body recognizes and defends itself~     against bacteria, viruses, and substances that may be harmful to the body.~      HIV-1 infected children typically respond more poorly to vaccines compared to uninfected,~     healthy children and so this study hopes to learn whether or not the body will successfully~     produce enough antibodies (proteins that fight infection) that will prevent or fight the H1N1~     flu virus. There is no information yet on the safety or immune response to this vaccine in~     children infected with HIV.~   "
159063|NCT01484080|"~     The investigators plan to study the efficacy of the combination of weekly paclitaxel + BIBF~     1120 in early breast cancer using a neoadjuvant schedule and a randomized phase-II trial~     design, comparing the efficacy vs. weekly paclitaxel alone, followed by surgery and~     subsequent standards of care (anthracycline based chemotherapy, radiation or hormonal~     blockade).~   "
159014|NCT01484717|"~     Cigarette smoking remains the most common source of preventable morbidity and mortality in~     the United States, with in excess of $167 billion in economic costs per year. Contingency~     management (CM), in which tangible incentives are provided contingent on a target behavior~     like abstinence, is highly efficacious in improving substance abuse treatment outcomes and is~     receiving increased attention for smoking cessation. Expired carbon monoxide (CO) is the most~     common objective smoking status test used in smoking research and treatment. Unfortunately,~     multiple CO tests/day are typically required to detect all smoking and reinforce sustained~     abstinence. The resulting logistical and resource limitations greatly limit the application~     of this potentially powerful quit smoking toolset. This study addresses these limitations by~     examining the effectiveness of using interactive voice response technology (IVR) to implement~     CM. Smokers who want to quit (N = 90 randomized) will receive 2 quit preparation sessions~     based on public health guidelines for smoking cessation and set a target quit date.~     Participants will be randomly assigned to 1 of 2 treatment conditions: (a) IVR-S consisting~     of objective smoking status monitoring using IVR, telephone counseling and transdermal~     nicotine and (b) IVR-CM, consisting of the same monitoring, telephone counseling and~     transdermal nicotine plus IVR-based CM for smoking abstinence. It is hypothesized that~     abstinence rates will be higher in the IVR-CM condition compared to the IVR-S, supporting a~     combined IVR CM approach, and thereby greatly increasing the applicability of these powerful~     smoking cessation tools.~   "
159015|NCT01484704|"~     The purpose of this study is to determine how MRI changes the treatment and diagnostics of~     ductal breast cancer. 100 women with newly diagnosed breast cancer will participate the~     study.~   "
159016|NCT01484691|"~     This will be a single center study of asthmatic subjects and healthy controls which will~     investigate mechanisms of asthma through detailed molecular analysis of airway tissues and~     fluids. The primary goal will be investigate the role of microRNAs in Th2-driven inflammation~     in asthma. The investigators hypothesize that asthma is associated with abnormal expression~     of miRNAs in T cells which favors differentiation into Th2-cells. The investigators further~     hypothesize that asthma is heterogeneous based on the presence and absence of Th2-driven~     inflammation and that abnormalities in T cell miRNA expression will be most prominent in a~     subgroup with high levels of Th2-driven inflammation (as assessed using molecular markers~     that the investigators have previously established). Finally, the investigators hypothesize~     that inhaled corticosteroids will normalize the T-cell miRNA abnormalities observed in~     asthma, as corticosteroids treat Th2-driven inflammation. The samples collected will also~     facilitate the pursuit of secondary analyses designed to investigate mechanisms of~     inflammation and remodeling in asthma as well as molecular phenotypes of asthma.~   "
159017|NCT01484678|"~     The purpose of this research study is to determine the potential of magnetic resonance~     imaging to monitor disease progression and to serve as an objective outcome measure for~     clinical trials in Duchenne Muscular Dystrophy (DMD). The investigators also hope to learn~     more about the changes that occur in muscles of the lower leg and arm in boys with DMD.~      The investigators will compare the muscles of ambulatory or non-ambulatory boys with DMD with~     muscles of healthy children of the same age and monitor disease progression in boys with DMD~     over a 5-10 year period. The amount of muscle damage and fat that the investigators measure~     will also be related to performance in daily activities, such as walking and the loss of~     muscle strength. In a small group of subjects the investigators will also assess the effect~     of corticosteroid drugs on the muscle measurements.~   "
159018|NCT01484665|"~     Decision-aids are tools to educate patients on a given topic so that they may better~     participate in shared-decision making in their health care. Given the complexities associated~     with PSA testing, many professional organizations have advocated for shared-decision making~     for PSA testing. However, no consensus exists as to how best educate and involve patients in~     the shared-decision making process. The goal of this study is to evaluate a pilot program~     utilizing a simple PSA screening decision-aid presented in two different fashions in a~     primary care clinic with a large fraction of African-American patients. The investigators~     will evaluate the effectiveness of this program to educate patients on the risks and benefits~     of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their~     decision about whether to receive PSA testing, and on the comfort level of physicians on~     their patient's decisions regarding PSA testing, and importantly, how well these strategies~     can be implemented into the daily work-flow of a clinic. If successful, this program may~     serve as a model for the broader implementation of such strategies across Minnesota and the~     country.~   "
159019|NCT01484652|"~     The primary objective of this study is to show the effectiveness of repeated doses of COV795~     versus placebo, using the summed pain intensity difference over the first 48 hours in~     subjects with acute moderate to severe pain following bunionectomy.~   "
159020|NCT01484639|"~     This is a multi-centre randomized controlled pilot trial of two transfusion strategies in~     high risk patients having cardiac surgery. This study will be conducted in 7 Canadian centers~     and 1 American centre. Patients allocated to a restrictive transfusion strategy will~     receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and~     postoperatively. Patients allocated to a liberal transfusion strategy will receive red cell~     transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and~     postoperatively in the intensive care unit, and less than 85 g/L on the ward.~      The primary objectives of this study are to determine 1) enrollment rates (patients~     enrolled/patients eligible), 2) consent rates (consent obtained/patients approached); and 3)~     protocol adherence (incidence and reasons for non adherence, lack of consent, rates of~     contamination and utilization of co-interventions). The secondary objectives are to determine~     1) the mortality rate and the rate of the composite outcome for morbidity of renal, cardiac,~     neurological and infectious adverse events; 2) the proportion of missing data as a measure of~     the feasibility of the case report form; and 3) the proportion of blood products utilized~     (red cells, platelets and plasma).~      The results of the multicentre pilot study will be used to 1) maximize enrollment rates to~     ensure timely completion of recruitment of a definitive large randomized controlled trial, 2)~     maximize adherence rates, 3) determine event rates for sample size estimation for a~     definitive study, and to 4) optimize the case report form.~   "
159835|NCT01473992|"~     The purpose of this study is to determine if transfemoral amputees of varied etiology will~     demonstrate increased function, safety and quality of life following accommodation with a new~     knee prosthesis as compared to their former C-Leg knee prosthesis.~   "
159030|NCT01484509|"~     Leg artery disease is a common condition in which fatty deposits develop in the blood vessels~     that supply the legs. Many patients with leg artery disease experience a cramp-like leg pain~     during walking that is relieved by rest; this is called intermittent claudication. To help~     determine the severity of leg artery disease, patients may be questioned about how far they~     can walk before claudication pain forces them to stop. However, this information is usually~     of limited use because most patients poorly estimate their walking capacity. The~     investigators have developed a simple questionnaire to help estimate walking capacity in~     patients with leg artery disease. The purpose of this study is to test the validity and~     reliability of this questionnaire. By validity, the investigators mean the extent to which~     the questionnaire measures what it is supposed to measure (walking capacity). By reliability,~     the investigators mean the extent to which the questionnaire produces the same results over~     time when completed on two different days.~      The investigators hypothesise that the investigators simple questionnaire will be valid and~     reliable.~   "
159031|NCT01484496|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab~     administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).~   "
159032|NCT01484483|"~     This observational study, conducted by the Kenya Society for Hematology and Oncology, will~     develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical~     and pathological characteristics, treatment and clinical outcome will be collected from newly~     diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry~     cohort and followed up for a period of not less than five years.~   "
159033|NCT01484470|"~     While cord blood transplants have been performed safely in elderly patients, many still~     relapse. The investigators propose to intensify the preparative regimen for this patient~     group in an attempt to decrease relapses, and combine this with an ex vivo expanded Umbilical~     Cord Blood (UCB) unit.~   "
159034|NCT01484457|"~     Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric~     model predictive control can be developed and evaluated safely in patients with Type 1~     Diabetes Mellitus (T1DM) to control blood glucose concentrations.~      This study seeks to combine real-time continuous glucose sensing with automated insulin~     delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end~     result of this line of research will be an artificial pancreas that will provide~     around-the-clock glucose regulation through controlled insulin delivery in response to~     detected patterns of change in glucose levels.~   "
159035|NCT01484444|"~     BIOMARKER ANALYSES~        1. FNA Sample:~           From each enrolled patient who meets the inclusion criteria, FNA sample will only be~          taken .~           FNA will be carried out only in patients with feasible biopsy or FNA site. Ascites or~          pleural fluid will be collected for analysis~        2. Blood Samples From each enrolled patient who meets the inclusion criteria, blood samples~          will be collected. 3 mL blood sample will be collected .~        3. tumor tissue Archived Tumor Tissue (Slides) Samples Primary tumor and/or a metastatic~          lesion collected. Approximately 5 unstained slides (if available) are collected.~   "
159036|NCT01484431|"~     The purpose of this study to see how much study drug is in the blood after dosing children~     with pulmonary arterial hypertension (PAH) and to establish the correct dose for further~     clinical research.~   "
159037|NCT01484418|"~     Chronic low back pain often results in psychosocial and physical disability. A subgroup of~     these patients shows fear of (re)injury and avoidance behaviour leading to higher disability.~     The purpose of this study is to determine whether exposure in vivo is more effective in the~     treatment of fear avoidant chronic back pain patients than psychological treatment as usual~     (cognitive behavioural psychotherapy).~   "
159038|NCT01484405|"~     There are two surgical approaches (incision types) used by surgeons who do total hip~     replacements. The purpose of this study is to determine which type of surgical approach~     (incision type) produces the best results for patients who have a total hip replacement.~      Null Hypothesis : There is no difference in complication rate, functional outcome, surgical~     time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or~     ORIF for femoral neck fractures.~   "
159039|NCT01484392|"~     The purpose of this study is to determine which medical, demographic, and health belief~     factors are associated with glaucoma therapy compliance.~   "
159040|NCT01484379|"~     Following a personal observation and a retrospective analysis of the data, the investigators~     hypothesise that there is increased frequency of multiple gland disease in primary~     hyperparathyroidism in the elderly.~      This study will include patients over the age of 65, diagnosed with primary~     hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according to~     preoperative imaging. Surgery will begin with a focal parathyroid exploration as suspected~     followed by an exploration of the other gland at the same time. Data will be analysed to~     determine the frequency of multigland disease in this population.~   "
159041|NCT01484366|"~     The hypothesis is that intramedullary nailing of the ulna and plating of the radius will~     result in a superior outcome as evidenced by two primary end points:~        1. a lower rate of implant pain~        2. a lower re-operation rate to remove painful hardware.~   "
159042|NCT01484353|"~     The purpose of this study is to determine if a healthy lifestyle intervention can~     significantly improve blood sugar control in type 2 diabetics over a course of 3 months.~   "
159043|NCT01484340|"~     The purpose of this study is to conduct a randomized controlled trial (RCT) of intensive~     anti-smoking counseling plus nicotine replacement therapy versus intensive anti-smoking~     counseling alone among HIV-infected patients in South Africa, and to concurrently measure the~     prevalence of smoking among HIV-infected patients in South Africa.~   "
159059|NCT01484132|"~     The Composites and Urinary Bisphenol-A Study (CUBS) is a clinical study of dental composite~     for its effects on urinary bisphenol-A levels. The study will enroll approximately 139~     children recruited from study-affiliated clinical sites in New England.The primary aim of~     CUBS is to test the hypothesis that urinary bisphenol-A (BPA) concentrations increase after~     composite restoration placement. BPA is a chemical used in the synthesis of matrix monomers~     and has been shown to have harmful effects in toxicological studies in laboratory animals.~     Currently it is unknown whether dental composite restorative materials containing monomers~     that are derived from BPA result in chronic low-dose BPA exposure in children.~   "
159044|NCT01484327|"~     Beta-blockers should be administered to all patients with heart failure stages II to IV NYHA.~     It should also be administered to patients with stage I after myocardial infarction. The low~     ejection fraction, especially after myocardial infarction is a strong indication for~     beta-blockers, as many studies indicate that administration of these drugs substantially~     reduces cardiovascular mortality. Beta-blockers reduce mortality and hospitalizations and~     improve the operational phase for all categories of patients with heart failure. Since~     beta-blockers, only carvedilol, metoprolol, and recently visoprololi nevimpololi have shown~     these benefits and thus, only those have to be administered.~      The clinical study Carvedia aims to observe and record the action of beta-blocker carvedilol~     on cardiac function in patients with heart failure or reduced left ventricular ejection~     fraction after acute myocardial infarction.~   "
159045|NCT01484314|"~     Eltrombopag is a compound that may help stimulate the production of platelets. This drug has~     been used in treatment of low platelet counts caused by a disorder called idiopathic~     thrombocytopenic purpura and information from those other research studies suggests that~     Eltrombopag may help to maintain platelet counts in patients with relapsed multiple myeloma~     in this research study.~      In this research study,the investigators are trying to determine if Eltrombopag is effective~     in maintaining platelet counts in patients who are being treated for relapsed multiple~     myeloma.~   "
159046|NCT01484301|"~     The purpose of this study was to assess the impact of opioid tolerability-related issues~     experienced by Canadian chronic pain patients. Approximately 170 patients were enrolled from~     16 recruiting centers across Canada. Eligible patients had a diagnosis of non-malignant,~     chronic pain requiring continuous use of strong opioids (>=4 days per week). Recruitment was~     initiated by physicians during routine care appointments at family or pain medicine~     practices. Patients were then directed to a website where they provided consent and completed~     an anonymized, password-protected, web-based survey that could be completed at home. This~     weekly online questionnaire was designed to document their chronic pain experience over a~     12-week period. At the end of the 12-week study, physicians were asked to retrospectively~     complete information about pain treatments, over-the-counter (OTC) medication use for pain~     and opioid-related gastrointestinal (GI) side effects, as well as co-morbid conditions for~     each patient.~   "
159047|NCT01484288|"~     The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx~     Barostim Neo System in the treatment of patients with heart failure.~   "
159048|NCT01484275|"~     The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with~     placebo (an inactive substance that is compared with a drug to test whether the drug has a~     real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma~     (SMM).~   "
159049|NCT01484262|"~     This study is conducted in Europe. The intention of this health service research study is to~     obtain data from daily routine to evaluate the quality of life and the costs of the disease~     for patients with type 2 diabetes mellitus.~   "
159050|NCT01484249|"~     This study was designed as a First In Man (FIM) trial to evaluate the feasibility and~     technical capability of the Claret CE Pro System in delivering two embolic filters to the~     brachiocephalic artery and the left common carotid artery during a Transcatheter aortic valve~     implantation (TAVI) procedure in order to protect the neurovasculature from debris liberated~     during the procedure.~   "
159051|NCT01484236|"~     RE-LAM-CE is a registry of lymphangioleiomyomatosis cases in France. its aim is to determine~     the incidence and prevalence of lymphangioleiomyomatosis in France, including demographic~     information and information concerning the timing and modalities of diagnosis.~      Based on the registry, we will set up a prospective cohort of patients. The database will~     include detailed medical information, particularly regarding progression of the respiratory~     function.~   "
159052|NCT01484223|"~     The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal~     intervention (BCI) in patients with somatization symptoms which has an effect on the~     perceived quality of life front conventional intervention.~   "
159053|NCT01484210|"~     The aim of this study is to establish the therapeutic equivalence between the test~     (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference~     formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the~     Fluticasone/Salmeterol combination.~      The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover~     fashion.~   "
159054|NCT01484197|"~     This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two~     different formulations of indacaterol maleate, both administered via the Concept1 device. The~     study aims to determine whether the novel formulation has a similar clinical profile as the~     established formulation.~   "
159055|NCT01484184|"~     As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy~     candidate called SPINALON has been identified and is currently under development for its~     capacity to temporarily induce episodes of involuntary locomotor movements. The primary~     objective of this Phase I/IIa study is to assess safety and tolerability of a single~     escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal cord-injured~     patients. As a secondary objective, preliminary evidence of efficacy will also be sought.~   "
159056|NCT01484171|"~     To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination~     with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched~     donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid~     leukemia (AML).~   "
159057|NCT01484158|"~     There are growing evidences that gait speed is inversely associated with all causes mortality~     especially cardiovascular mortality among the elderly. The purpose of this study is to~     evaluate the predictive value of gait speed for cardiovascular events in patients after~     ST-segment elevation myocardial infarction (STEMI).~   "
159058|NCT01484145|"~     The purpose of this study is to determine how much terbinafine is delivered to the nail bed~     after treatment with a number of modifications to a previously studied method for~     iontophoretic delivery of terbinafine gel. Iontophoretic delivery involves the use of a small~     electric charge to deliver drug across skin and nails.~   "
159060|NCT01484119|"~     This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly~     patients with seasonal allergic rhinitis, due to mountain cedar pollen.~   "
159064|NCT01484067|"~     If a person qualifies to participate in this study, they will have an equal chance of being~     assigned to either of two groups. One group will receive a patch that they will need to carry~     with them, because as soon as a cold sore starts (within 1 hour) they will need to put the~     patch over the sore. The other group will not get a patch, but will need to follow the other~     instructions anyway.~      When a subject's outbreak begins, they will need to return to the study center within 24~     hours. Then they will return according to the appointments given within 10 days. If the study~     staff sees that their sore has healed enough before 10 days, subjects will be told that they~     don't need to return again.~      As long as subjects are in the study, they will need to answer a few simple questions every~     day on a card or booklet called a diary, starting the first day of their outbreak. If a~     subject is assigned to the patch group, they must wear the patch all the time, taking it off~     only to replace it (if it gets loose, dirty, or unsightly) and at the study center, when they~     are asked to remove the patch so the sore can be checked.~      During the study subjects will be allowed to use paracetamol for pain, but no other~     treatments or medicine. If they use paracetamol, subjects must record it in their diary. The~     study will be stopped, and there will be no subject visits or treatments during the end of~     year holiday break. If a subject experiences an outbreak during the holiday, they may follow~     their usual treatment routine.~   "
159065|NCT01484054|"~     To evaluate and compare the performance of a new contact lens to a marketed contact lens.~   "
159066|NCT01484041|"~     This study is for women with confirmed hormone receptor positive HER-2 negative advanced~     breast cancer with evidence of disease resistance to an aromatase inhibitor.~      The purpose of this study is to determine how well these medications work together and/or if~     they have any side effects in patients with hormone-receptor positive metastatic breast~     cancer who have demonstrated progression of disease after first line hormonal therapy.~      This research is being done to determine if taking an already approved medicine (aromatase~     inhibitor) in combination with a new medication (dovitinib) results in better outcomes for~     patients with this disease.~      Both dovitinib and an aromatase inhibitor are pills that will be taken at home.~   "
159067|NCT01484028|"~     This study will serve to evaluate and compare the performance of two new lenses to a marketed~     lens.~   "
159068|NCT01484015|"~     This randomized pilot clinical trial studies how well giving prolonged infusion compared to~     standard infusion of cefepime hydrochloride works in treating patients with febrile~     neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective~     than giving cefepime hydrochloride over the standard time.~   "
159069|NCT01484002|"~     This retrospective study will investigate the changes that occur in ultrahigh molecular~     weight polyethylene (UHMWPE) implants that have been retrieved from joint replacement~     patients. Analysis techniques will include Fourier Transform Infrared Spectroscopy (FTIR),~     Differential Scanning Calorimeter (DSC) and crosslink density measurements. Crosslink density~     measurements will be evaluated as a function of distance away from the articular surface and~     the rim of the implant. Gel and hydroperoxide contents will also be evaluated. The objective~     is to characterize the in vivo and ex vivo changes that occur with cross-linked and~     conventional polyethylene bearings sterilized by methods that do not involve radiation. The~     investigators hypothesize that polyethylene absorbs lipids in vivo but experiences negligible~     oxidation or reductions in polymer crosslinking until it is explanted and stored at room~     temperature with access to ambient air.~   "
159070|NCT01483989|"~     The purpose of this study is to measure corneal epithelial changes in dry eye subjects using~     a novel lubricant eye gel.~   "
159071|NCT01483976|"~     The objective of this study is to verify changes in protein metabolism after ingesting a oral~     medical nutritional supplement.~   "
159072|NCT01483963|"~     The objectives of this study are to assess the safety, effectiveness, and immunogenicity of~     AA4500 in the treatment of adhesive capsulitis.~   "
159073|NCT01483950|"~     This study is non-interventional study of patients who are treated with any HMGCoA reductase~     inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and~     Herzegovina for at least 6 months. Data collection for each patient will take place at a~     single visit. The investigators will complete Case Report Form (CRF) with patient's~     demographic, the presence of the factors for high cardiovascular risk, current treatment,~     cholesterol value as well as with further treatment decision.~   "
159074|NCT01483937|"~     Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment~     Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance~     physical therapy for rehabilitation of patients who fall as a result of vestibular inducted~     disequilibrium.~      Study participants will receive regular physical therapy, and some will use the SEMD device~     while receiving usual care vestibular-balance physical therapy. The device is an elastic belt~     that holds eight small battery powered vibrating disks. When using the device, you will sit~     or stand on a force platform that measures body sway. That movement information is sent to a~     computer which then sends the information to you via the vibrating disks. The vibrating disks~     are similar to a vibrating cell phone: you can feel the vibration but it is not~     uncomfortable. You can also see your sway movement on the computer screen. Some tests and~     activities will be paced with a beeping sound.~      The aim of this study is six-fold: 1. Demonstrate the relative efficiency between SEMD and~     conventional vestibular-balance physical therapy as reported by treating physical therapists'~     by counting number of skills acquired in a treatment session, and the amount of time needed~     to acquire the skill; 2. Demonstrate greater improvement earlier on in balance test scores~     when using the SEMD as an adjunct to conventional vestibular-balance physical therapy; 3.~     Determine the difference in vestibular habituation between physical therapy plus SEMD and~     conventional vestibular-balance physical therapy; 4. Demonstrate a more immediate reduction~     in fall occurrence when using SEMD as an adjunct to conventional vestibular-balance physical~     therapy; 5. Determine the patient's perception of quality of life between physical therapy~     plus SEMD and conventional vestibular-balance physical therapy; 6. Determine difference in~     acquisition of large movement tasks of tandem walk, step quick-turn, and kneel-shoulder~     rifle-return to stand between subjects that have trained with SEMD and conventional~     vestibular-balance physical therapy .~      In addition to primary and secondary outcome measurements, efficiency of skill acquisition,~     devised for this study, will be evaluated by tracking the number of skills and length of time~     needed to acquire each skill for each physical therapy session using the Patient Skill~     Acquisition Chart (PSAC). Usefulness of Tandem Walk, Step Quick-turn, and Kneel- Shoulder~     Rifle-Return to Stand as intervention outcome, also devised for this study, will be evaluated~     with pre test to post tests Modified Functional Independence Measure - Motor (MFIM-Motor).~     These measurements were devised for this study, and will be evaluated for informational~     purposes only.~   "
159075|NCT01483924|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,~     pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with~     moderate to severe chronic plaque psoriasis.~   "
159076|NCT01483911|"~     ALX-0171 is a Nanobody directed against the human respiratory syncytial virus (RSV). The~     purpose of this first-in-man study is to determine the safety, tolerability and~     pharmacokinetics (PK) of ALX-0171 after single and multiple pulmonary administrations in~     healthy male volunteers.~   "
159916|NCT01472913|"~     The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss,~     pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on~     Range Of Movement (ROM) and strength is examined.~   "
159077|NCT01483898|"~     This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a~     patient-specific expanded multicellular therapy, for the treatment of patients with critical~     limb ischemia (CLI). The study is a randomized, vehicle controlled (placebo)study in CLI~     patients who have no option for revascularization procedures. All patients randomized will~     undergo a small volume bone marrow aspiration in a 15-minute outpatient or in-office~     procedure. All patients will receive injections of either ixmyelocel-T or vehicle-control~     into their pre-identified index leg. Patients will be followed for 18 months.~   "
159078|NCT01483885|"~     Physiotherapy offers a range of therapeutic modalities for pain management including~     Transcutaneous Electrical Nerve Stimulation (TENS), Interferential current (IC) and~     Acupuncture. The objective of this study was to investigate the hypoalgesic effect of TENS,~     CI and Acupuncture in a cold-induced pain model.~   "
159079|NCT01483872|"~     Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the~     use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in~     addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated~     bacteremia via a catheter-salvage strategy.~      The investigators plan to randomize 102 patients with hemodialysis catheter-associated~     bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for~     treatment of their infection. Additionally, patients randomized to the interventional arm~     will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and~     heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only~     an anticoagulant solution as a catheter lock which is standard of care - this can be either~     heparin or citrate (depending on what agent is standard of care for a particular patient).~     The main outcome of interest is successful treatment which is defined as a resolution of the~     current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of~     follow-up.~   "
159080|NCT01483859|"~     Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France) is a newly~     introduced noninvasive tool that generates an elastic wave using a vibrator applied to the~     thoracic wall at the level of the right lobe of the liver and measures the prolongation~     velocity of the wave, which is directly associated with liver stiffness (LS). Although recent~     advances in surgical techniques and perioperative management have made with established~     perioperative management have now made it possible to perform hepatectomies as a safe~     procedure with minimum mortality, the possibility of massive blood loss and resultant~     transfusion during hepatectomy still exist. The objective of this research was to identify~     the role of liver stiffness measurement for the prediction of intraoperative blood loss and~     postoperative recovery after elective right hepatectomy.~   "
159081|NCT01483846|"~     This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female~     subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on~     capsaicin-induced hyperalgesia will be assessed.~   "
159082|NCT01483833|"~     To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied~     twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.~   "
159083|NCT01483820|"~     The purpose of this research study is to evaluate a new investigational drug (TPI 287) for~     neuroblastoma and medulloblastoma. An investigational drug is one that has not yet been~     approved by the Food and Drug Administration. This investigational drug is called TPI 287.~     This study will look at the tumor's response to the study drug, TPI 287, as well as the~     safety and tolerability of the drug.~      TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in~     three different animal species. TPI 287 has been tested in humans in four clinical trials,~     and approximately 100 subjects with various types of cancers have received the drug,~     including a pediatric population in our previous Phase I trial.~   "
159084|NCT01483807|"~     This study is designed to examine the effects of speech therapy on ability to produce speech~     sounds in persons with acquired apraxia of speech.~   "
159085|NCT01483794|"~     This is an observational study looking at the characteristics of patients consulting for~     genital warts in the first semester 2010 at the public sexual health clinic of Valparaiso,~     Chile. The objectives are: to have an epidemiological profile, estimating cost of the disease~     for the health system and the patient and analyzing possible psychosocial consequences of the~     condition for the patients.~   "
159086|NCT01483781|"~     The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and~     renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin~     and being treated for high blood pressure.~   "
159087|NCT01483768|"~     Subject: Evaluation of the impact of obesity surgery by sleeve gastrectomy on intestinal iron~     absorption of morbid obese subjects.~      Control of intestinal absorption of iron is mediated by hepcidin, which is expressed in~     adipose tissue and that its expression is increased in morbidly obese subjects. The working~     hypothesis is that this increase could explain the high prevalence of systemic iron depletion~     observed in obese patients.~      Main objective: Assess the impact of the decrease in fat mass induced by surgery in obese~     patients on the intestinal absorption of iron (evaluated by measuring the expression of iron~     transporters in the duodenum)~   "
159088|NCT01483755|"~     The investigators previously reported that angioplasty postconditioning reduces infarct size~     (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital~     admission. Animal studies have suggested that the time window for applying brief episodes of~     ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow,~     i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window~     might be larger in humans, i.e. whether STEMI patients might be protected several minutes~     after undergoing spontaneous reperfusion before admission coronary angiography.~      Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1~     were eligible for that study. Angioplasty postconditioning was completed as already published~     and infarct size was assessed by measuring cardiac enzymes release.~   "
159506|NCT01478295|"~     The purpose of this study is to evaluate the effectiveness of a structured nursing~     intervention (PCE), including two types of intervention defined in the literature (coping~     strategies promoting social support and empowerment through health education), which has an~     effect on the perceived quality of life for the caregiver, when compared with conventional~     intervention or non-support.~   "
159089|NCT01483742|"~     This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and~     antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon~     alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the~     combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or~     4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily~     (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin~     1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid~     additionally. Anticipated time on study treatment is 24 weeks.~   "
159090|NCT01483729|"~     This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate~     the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1,~     subjects will be randomized to receive single oral doses of one of three tablet formulations~     of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout~     between periods. In Part 2, subjects will be randomized to receive single oral doses of one~     of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with~     at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.~   "
159091|NCT01483716|"~     Obesity is an escalating problem in the UK and a proportion of these patients have a~     condition known as Obesity Hypoventilation Syndrome (OHS). This syndrome is associated with~     symptoms of breathlessness, reduction in exercise capacity, fatigue and headaches. Previous~     research has shown that patients with this condition tend to use healthcare services more~     frequently and are often at risk of other diseases such as diabetes mellitus and high blood~     pressure. Currently, the mainstay of treatment is noninvasive ventilation (NIV), this is a~     mask ventilator that patients use overnight to improve oxygen levels and remove carbon~     dioxide (the waste gas of breathing), however this does not fully treat the underlying~     problem. The research group has shown that NIV helps improve activity and contributes to~     weight loss in this group of patients. The aim of this research will be to investigate the~     effect of an exercise and nutrition programme in addition to NIV on weight loss and activity~     levels compared to NIV alone.~   "
159092|NCT01483703|"~     The purpose of this study is to determine whether reflections of light can be used to provide~     real-time pictures of blood vessel formation around infants' heads. This study device is~     called laser speckle imaging.~   "
159093|NCT01483690|"~     This is a pilot study using decitabine and vorinostat before and during chemotherapy with~     vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with~     acute lymphoblastic leukemia (ALL).~   "
159094|NCT01483677|"~     The investigators believe that subjects who practice on the Nintendo Wii will improve their~     laparoscopic skills more than those who practice on the Playstation2.~   "
159095|NCT01483664|"~     The purpose of this study is to improve the communication skills of physicians who transition~     lymphoma cancer patients from the end of treatment to survivorship.~   "
159096|NCT01483651|"~     The purpose of this research study is to test how different levels of insulin block the~     effect of glucagon. Insulin is a hormone that lowers blood glucose. Glucagon raises blood~     glucose. Both are natural hormones made by people without diabetes. Sensor-based blood~     glucose control studies have been done by our research group using glucagon in small doses to~     prevent hypoglycemia (low blood sugar). However, sometimes glucagon does not work to raise~     blood sugar. The investigators believe this is because of too much insulin in the body. This~     study will help determine how different levels of insulin in the body affect the ability of~     glucagon to raise blood sugar.~   "
159097|NCT01483638|"~     The purpose of this study is to evaluate the maintenance therapy with axitinib in patients~     with metastatic colorectal carcinoma~   "
159098|NCT01483625|"~     The aim of the study is to investigate whether the early introduction of maintenance~     bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on~     the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier~     in their disease state and start maintenance therapy, if appropriate.~   "
159099|NCT01483612|"~     BACKGROUND: Obesity increases the risk of polycystic ovary syndrome (PCOS), characterized by~     anovulatory cycles, but it is also associated with reduced fertility even in ovulatory women.~     Moreover, obesity increases the costs of assisted human reproduction (AHR) treatments and~     reduces their efficacy. In addition to fertility disorders, obesity increases significantly~     the risks of many complications of pregnancy, delivery and neonatal health. However, a modest~     loss of 5-10% of total body weight can restore ovulation and improve pregnancy rates.~      OBJECTIVES: 1) To design and implement a multidisciplinary program for lifestyle management~     of obese women, or overweight women with PCOS, who seek fertility treatment in a secondary~     AHR center. 2) To evaluate lifestyle benefits of this program and assess its impact on~     fertility, pregnancy and neonatal outcomes, as compared to a randomly assigned control group~     and to similar women seen in tertiary AHR centers. 3) To assess cost per live birth, and~     other measures of cost-effectiveness, of this program compared to the control group and~     tertiary AHR centers. 4) To effectively transfer knowledge obtained through these activities~     to relevant stakeholders in the health care and public health sectors.~      METHODS AND APPROACH: In order to design the program for lifestyle management of obesity in~     infertile women, we will gather a Committee composed of members of our interdisciplinary~     research team and relevant collaborators. Objectives 2 and 3 - In order to achieve these~     objectives, 128 obese women (BMI ≥ 30 kg/m²), or overweight women with PCOS (BMI ≥ 27 kg/m²),~     consulting at the CHUS fertility clinic will be randomized to our lifestyle program, and will~     suspend fertility treatments for six months, or to standard fertility treatments, which are~     directly initiated. The results obtained will also be compared to those of women with the~     same criteria who will consult in 3 tertiary AHR clinics not offering a similar lifestyle~     management program.~      IMPACT: This project is very important as it will generate new knowledge about the~     implementation, impacts and costs of a new lifestyle management program in obese infertile~     women. Our project will obtain valuable data on implementability of such a program; on~     benefits with regard to lifestyle, fertility and maternal and foetal complications during~     pregnancy; as well as on reduction in cost per live birth and other cost-effectiveness ratio.~   "
159100|NCT01483599|"~     The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the~     treatment of patients with moderate to severe plaque psoriasis.~   "
159101|NCT01483586|"~     This research is being done to evaluate the safety and efficacy of the investigational~     Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.~   "
159116|NCT01483391|"~     Children or teens with mood swings or depression who have a parent with bipolar disorder are~     at high risk for developing bipolar disorder themselves. This study will test a family-based~     therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk~     children (ages 9-17). In a randomized trial, the investigators will compare two kinds of~     family-based treatment (one more and one less intensive) on the course of early mood symptoms~     and social functioning among high-risk children followed for up to 4 years. The investigators~     will examine the effects of family treatment on measures of neural activation using~     functional magnetic resonance imaging.~   "
159102|NCT01483573|"~     This study was designed to answer 3 primary research questions:~        1. In adults with low back pain, reduced SLR ROM (Range of Motion) and a positive~          sensitized SLR (Straight leg raise) test, does neurodynamic mobilization result in~          greater SLR ROM, pain reduction and perceived improvement than muscle stretching?~        2. In adults with low back pain, reduced SLR ROM and a negative sensitized SLR test, does~          muscle stretching result in greater SLR ROM, pain reduction and perceived improvement~          than neurodynamic mobilization?~        3. In adults with low back and reduced SLR, does neurodynamic mobilization or muscle~          stretching result in greater SLR ROM, pain reduction and perceived improvement~          irrespective of the outcome of SLR sensitization?~      The research hypotheses are threefold:~        1. Subjects determined to have nerve-related pain and ROM restrictions by a positive~          sensitized SLR test would benefit more from neurodynamic mobilization than muscle~          stretching.~        2. Subjects determined to have muscle-related pain and ROM restrictions by a negative~          sensitized SLR test would benefit more from muscle stretching than neurodynamic~          mobilization.~        3. Subjects would benefit the same from muscle stretching and neurodynamic mobilization~          when not matched on the outcome of the SLR sensitization.~   "
159103|NCT01483560|"~     The trial is conducted in the UK, Australia, Canada, Denmark and the Netherlands. The aim is~     to test whether 3 years treatment with metformin added to titrated insulin therapy (towards~     target HbA1c7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid~     IMT, in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for~     cardiovascular disease.~   "
159104|NCT01483547|"~     The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien)~     in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI)~     and Return of Consciousness (ROC) in neurosurgical patients are compared to those of~     non-neurosurgical patients, during routine anesthesia procedures.~   "
159105|NCT01483534|"~     The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or~     TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM~     will also be evaluated through confirmation of successful application of TLD Therapy.~   "
159106|NCT01483521|"~     This is a proposed home visitation program for families of children with externalizing~     behaviors who are on the wait list for psychiatric assessment at BC Children's hospital. The~     aim of this program is to implement and evaluate a home visitation strategy in order to~     support those waiting up to four months to consult a psychiatrist.~   "
159107|NCT01483508|"~     The purpose of this study is to determine whether or not the intake of dietary procyanidins~     (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans.~   "
159108|NCT01483495|"~     The brain is such a metabolically active organ that it consumes about 20% of oxygen burned~     every minute by an average adult even though it only contributes about 2% of the body weight.~     As a result, the brain produces a disproportionately high amount of CO2 every minute in~     comparison with the rest of the body.~   "
159109|NCT01483482|"~     Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures~     seen in orthopedics.~      There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle~     fractures. Conservative treatment has, traditionally, been the preferred treatment but recent~     studies have shown higher incidences of non-union and symptomatic malunion associated with~     conservative treatment. Primary surgery has in several studies been associated with high~     success rates and few complications but there is no compelling evidence towards superior~     results after primary surgery.~      The objective of this randomized study is to compare conservative treatment (sling) with~     primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.~   "
159110|NCT01483469|"~     This open label, non-randomized, parallel group study will evaluate [11C]-RO5011232 as~     radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to~     human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III,~     positron emission tomography (PET) assessments of specific uptake of the radiotracer and~     whole body dosimetry will be made after intravenous injection of [11C]-RO5011232. In Part IV,~     subjects will receive RO4917523 orally daily for 14 days while receiving three single~     intravenous bolus injections of [11C]-RO5011232. The anticipated time on study treatment is~     up to 4 weeks.~   "
159111|NCT01483456|"~     Falls among elderly inpatients are common, multifactorial and associated with a significant~     increase of complications and morbidity. According to a recent Cochrane review, the~     effectiveness of fall prevention program has been assessed in community-dwelling and in long~     stay wards but not in rehabilitation wards (RW) and geriatric acute wards (GAW). IPR study~     aims to measure the impact of a multidisciplinary prevention program on falls in elderly~     inpatients.~   "
159112|NCT01483443|"~     This is a prospective phase III trial to define the role of oophorectomy in metastatic~     colorectal cancer patients with ovarian metastasis.~   "
159113|NCT01483430|"~     In this study, we investigate the effects of Ginseol Kg1 (Korea red ginseng extract) on blood~     pressure in prehypertensive or stage I hypertensive patients.~   "
159114|NCT01483417|"~     Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus~     conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS~     is not inferior to that of conventional approach.~   "
159115|NCT01483404|"~     This project investigates wether the intra-capsular hematoma, that often occurs after~     fracture of the femural neck, decreases the capillary blood flow of the caput femoris.~      During operation the measuring device of the O2c-machine in placed on the joint capsula first~     and afterwards, after surgical opening of the capsula, on the femur directly. The integral of~     the microcirculation of both parts of the femur is measured in both settings. So the~     capillary blood flow is measured with the hematoma still in situ, eventually putting pressure~     on the caput femoris and after the capsula has been opened, the pressure relieved and the~     hematoma removed. Both measurements are compared for each patient.~      The O2c-machine measures non-invasive with light waves and laser-doppler. The sounding rod is~     packed in a sterile tube to prevent any contamination of the operation site.~   "
159117|NCT01483378|"~     The purpose of this study is to determine if vaccination rate of eligible patients at a major~     urban public hospital will increase by having ophthalmologists screen patients for~     eligibility and a nurse administer the vaccine in the General Eye Clinic.~   "
159119|NCT01483352|"~     The Accu-Chek DiaPort system enables continuous intraperitoneal insulin infusion (CIPII):~     that is, infusion of insulin into the peritoneal cavity using an Accu-Chek insulin pump and~     an infusion set. The Accu-Chek DiaPort consists of a metal body with a catheter that is~     placed in the abdomen. The opening of the port is raised above the surface of the skin about~     5 millimeters, while a flower-shaped plate is placed under the skin, providing stability for~     the port. The port has been designed for those diabetics who cannot benefit fully from~     subcutaneous insulin infusion. The primary objective of the study is to assess the~     suitability of Accu-Chek DiaPort to perform continuous intraperitoneal insulin delivery. The~     data collection focuses on the condition of tissue around the port after the implantation,~     possible peritoneal reactions to the port system, and the peritoneal delivery of insulin.~     Secondary objectives are the assessments of therapeutic performance and successful~     implementation of design requirements. In total 12 Patients will participate in this open,~     mono-centre, single-arm, interventional clinical trial. The study lasts 9 months (without run~     in period of 3 to 1 week) separated in two parts. Phase I last 12 weeks. Phase II last 6~     month until the end of the study. During the study, seven visits are planned. The screening~     visit can take place up to 3 weeks before study start. At the implantation visit which can~     last up to 5 days the port will be implanted. After the implantation insulin therapy will be~     adjusted for CIPII and the patients will be trained for handling and daily care of the~     Accu-Chek DiaPort system. To check the functionality of the system, the first control visit~     will take place 2 weeks and the second control visit 6 weeks after the implantation. At the~     week 12 visit, the most important parameters will be collected for the phase I report. The~     following visits take place 6 and 9 months after the implantation.~   "
159120|NCT01483339|"~     Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder.~     However, the majority of treated patients remain symptomatic. The metacognitive therapy by~     Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this~     study is to investigate this approach with a randomized controlled trial by comparing~     metacognitive therapy with exposure and response prevention for obsessive-compulsive~     disorder.~   "
159121|NCT01483326|"~     This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra~     (tocilizumab in participants of the ACT SURE clinical trial and further patients with~     moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be~     collected from each patient for up to 4 years.~   "
159122|NCT01483313|"~     Animal studies showed that many general anesthetics might result in neuron apoptosis and~     neurocognitive impairment in the developing brain. However results from human studies are~     conflicted. In present study, the investigators examined the association between early~     exposure to anesthesia and surgery for minor surgery and intelligence changes in adolescence~     using the Wechsler Intelligence Scale for Children.~   "
159123|NCT01483300|"~     Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line~     treatment for metastatic breast cancer patients, especially for those previously treated with~     anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum,~     has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal~     reaction. The purpose of the study is to compare the efficacy and safety of~     gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast~     cancer.~   "
159124|NCT01483287|"~     IBS (irritable bowel syndrome) is a functional gastrointestinal disorder which is~     characterized by recurrent pain and/or discomfort, altered stool form, and abdominal~     distension. It has been established that food items such as beans, peas, lentils, peppers,~     and onions can increase gas production. What these have in common is that they all contain~     large amounts of complex carbohydrates. The enzymes in the small intestine are not able to~     fully digest these large molecules, which in turn are fermented by the colonic microflora.~     This fermentation is conducted through the production of short chain fatty acids and gases~     such as hydrogen and methane. Alpha-Galactosidase is an enzyme that has the ability to break~     down these indigestible carbohydrates to galactose and sucrose in the small intestine and to~     facilitate the absorption and minimize the gas production from bacteria in the colon.~      The aim of this study is to assess if the gastrointestinal symptoms, above all problems from~     gas and distension, is alleviated when the enzyme α-Galactosidase (present in Nogasin~     capsules) is ingested with food.~   "
159125|NCT01483274|"~     Patients with Acute Myelogenous Leukemia (AML) who relapse after an allogeneic stem cell~     transplant cell receive decitabine to up regulate cancer antigen expression, followed by a~     donor lymphocyte infusion and an autologous dendritic cell (DC). Vaccine Dendritic cells are~     pulsed with overlapping peptides derived from MAGE-A1, MAGE-A3, and NY-ESO-1.~   "
159126|NCT01483261|"~     To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with~     Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This~     study seeks to fill this gap by designing, implementing and testing such an intervention~     using both an intervention and waiting list control group.~   "
159127|NCT01483248|"~     Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage~     liver diseases. However, the critical shortage of donor organs, high cost, and the problem of~     immune rejection limit its clinical application, and even some patients on the waiting list~     will never survive to receive a matched liver. Stem cell transplantation instead of~     conventional medical therapy or orthotopic liver transplantation will be a promising~     alternate approach to regenerate damaged hepatic mass. Adult mesenchymal stem cells (MSCs)~     are generally thought of as an autologous source of regenerative cells in previous studies.In~     this study, the safety and efficacy of menstrual blood-derived stem cells transplantation for~     patients with liver cirrhosis will be evaluated.~   "
159128|NCT01483235|"~     Standard cardiac rehabilitation programs (sCRP) aim to improve risk factors for heart disease~     such as high blood pressure, weight control, exercise and diet in order to decrease the~     chances of having heart problems in the future. These programs decrease morbidity and~     mortality but face important challenges: 1) Long waiting lists to participate in these~     programs. For example, St. Paul's Hospital has an intake capacity of 480 patients per year.~     Patients usually wait one to three months to start the program. 2) There is a vast~     heterogeneity of patients within the same program, from those that have never experienced~     heart problems to those that have already had a heart attack, chest pain or stroke.~     Therefore, patients with different medical problems receive the same treatment. 3) Facilities~     can be inconveniently located which leads to transportation difficulties, 4) The program is~     time consuming and classes are held in working times, 5) Shortly after completion, patients~     seem to lose what they have gained in the program. These caveats need to be addressed to~     improve the efficacy, delivery and capacity of sCRP for the increasing population of patients~     with heart disease.~      The investigators want to compare a reduced cardiac rehabilitation program (rCRP) with the~     standard cardiac rehabilitation program (sCRP) in patients with risk factors for heart~     disease as well as patients that already suffer from this condition, including those at~     higher risk. The rCRP will offer the same services as the sCRP; the only difference is the~     number of hospital based exercise sessions. While the sCRP offers 32 hospital based~     supervised exercise sessions, the rCRP will offer 10 hospital based exercise sessions. The~     rCRP would be a 'middle of the road alternative program' that would have the benefits of a~     hospital based program and the flexibility of a home based intervention. The rCRP would offer~     an alternative for patients that do not need constant supervision and would allow the sCRP~     health care team to focus on those patients who have more serious heart conditions. The rCRP~     would be a unique intervention because it integrates a less intensive cardiac rehabilitation~     into the pre-existing sCRP model. This alternative would help overcome the caveats of~     standard cardiac rehabilitation programs.~   "
159129|NCT01483222|"~     The main objective of this study is to investigate the efficacy of two different design~     characteristics of lumbar support for low back pain prevention in hospital nurses.~   "
159130|NCT01483209|"~     The goal of this project is to determine if performing a chemical sympathectomy by~     injecting botulinum toxin A in critically ill patients on vasopressors can treat digital~     ischemia. This is a prospective, non-randomized pilot study designed to demonstrate proof of~     concept. We propose to study patients in the intensive care units of Duke Hospital who,~     secondary to exposure to vasoactive medications used to maintain acceptable blood pressures,~     have developed signs and symptoms of digital ischemia. A paired T-test will be used to~     compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will~     again use a paired t-test to compare the experimental hand against the contralateral control~     hand. There were no major adverse events reported by the product information sheet or in~     other related studies of Botox for digital ischemia.~   "
159131|NCT01483196|"~     This clinical trial studies vascular and cognitive assessments in patients with breast cancer~     undergoing chemotherapy after surgery. Learning about vascular and cognitive function may~     help plan treatment and improve the quality of life of breast cancer patients. Transcranial~     Doppler ultrasound (TCD) may help study the side effects of chemotherapy in breast cancer~     patients and allow doctors to plan better treatment~   "
159132|NCT01483183|"~     The purpose of Part 1 of this study is to determine the maximally tolerated dose of~     OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).~      The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of~     OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.~   "
159133|NCT01483170|"~     This trial will study the tolerability and pharmacokinetic of fexinidazole using two~     different dosage regimen of repeated administrations. The drug is administered to human~     healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with~     a loading dose during 4 days.~   "
159134|NCT01483157|"~     Resistance exercise plus vascular occlusion may induce greater improvements in strength and~     muscle mass resistance training alone. The investigators speculate this training strategy~     could be beneficial in patients with rheumatoid arthritis.~   "
159135|NCT01483144|"~     The purpose of this randomized, double-blind, Phase III trial is to determine if the~     combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single~     agents in delaying time to the first occurrence of any FAP-related event. This includes: 1)~     FAP related disease progression indicating the need for excisional intervention involving the~     colon, rectum, pouch, duodenum and/or 2) clinically important events which includes~     progression to more advanced duodenal polyposis, cancer or death.~   "
159136|NCT01483131|"~     Resistance exercise plus vascular occlusion may induce greater improvements in strength and~     muscle mass than resistance training alone. The investigators speculate this training~     strategy could be beneficial in patients with osteoarthritis.~   "
159137|NCT01483118|"~     The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual~     cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary~     purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin~     resistance in larger group of study subjects.~      Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing~     age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming~     pregnant. The syndrome can also be associated with more serious conditions such as heart~     disease, diabetes, or cancer of the uterus. Although no one knows the cause of the syndrome,~     scientific studies showed that having too much insulin can be one of the reasons. In fact,~     almost every overweight woman with PCOS has been found to have high insulin levels.~      Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may~     also reduce the body's insulin level. Another study showed that daily use of cinnamon for~     forty days lowered the blood sugar level in patients with diabetes. Our own study also showed~     that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The~     purpose of this study is to see if cinnamon can help women with PCOS have more regular~     periods.~   "
159138|NCT01483105|"~     The proposed study is designed to utilize a self-hypnosis DVD home-training program for~     parents to use with their children to teach self-hypnosis techniques for inducing relaxation~     and hypnotic analgesia. These relaxation techniques can be employed to manage anticipatory~     anxiety, distress, and pain during an invasive medical procedure, for example, voiding~     cystourethrography (VCUG). The study will examine the efficacy of this intervention for~     children undergoing VCUG procedures.~   "
159139|NCT01483092|"~     Prebiotics are non-digestible food ingredients that beneficially affect the host by~     selectively stimulating the growth or activity of species in the colon that can improve host~     health.~      Inulin-type fructans (inulin and oligofructose) are natural food ingredients with prebiotic~     activity. Fermentation of inulin and oligofructose by lactic acid producing bacteria results~     in an increase in bacterial biomass and the production of SCFA (acetate, propionate and~     butyrate), lactic acid and the gases CO2 and H2. They are naturally present in significant~     amounts in several vegetables such as garlic, artichoke, onion, asparagus, leek and wheat~     (1-4%). Based on consumption data, the daily intake of inulin in Europe varies between 3.2~     and 11.3g mainly from wheat (2-7.8g/d). However, this might have changed recently since~     inulin and oligofructose are used by the food industry either as sucrose and fat replacements~     or due to their health benefits for the human host.~      Several human absorption studies evaluated the effect of inulin/oligofructose on mineral~     absorption. It was shown that calcium and magnesium absorption was positively influenced.~     Until now, the positive effect on iron absorption was only shown in animals. The influence on~     human iron absorption was investigated twice. Both studies reported no effect of~     inulin/oligofructose on iron absorption, but this was most likely due to poorly conceived~     study designs.~      The aim of the present study is to demonstrate that inulin consumption over several weeks can~     lead to enhanced iron absorption in humans under optimized conditions.~   "
159140|NCT01483079|"~     Human milk feeding is associated with great benefits to the health and development of~     infants, especially in premature infants. Some mothers are unable or unwilling to provide~     breast milk to their infant. The use of donor human milk products for very low birth weight~     infants as an alternative to cow milk has risen dramatically in the past year.~      Purpose: To evaluate post-discharge growth and neurodevelopment of infants less than or equal~     to 1250 grams birth weight receiving an exclusive human milk protein diet.~   "
159141|NCT01483066|"~     The currently held belief is that total knee replacement (TKR) requires the restoration of~     the overall limb alignment to coincide with the mechanical limb axis. To align the knee~     implants with this mechanical axis, rods are used to orient cutting guides with the~     mechanical axis as defined by the center of the femoral head and talus. Standard surgical~     technique typically involves femoral and tibial rods with cutting blocks to facilitate the~     intraoperative alignment of the initial femoral and tibia bone cuts. This approach is the~     method used for the traditional TriathlonÒ instrumentation. The Patient Specific Cutting~     Guides are designed to offer an alternative for alignment rods. ShapeMatch Technology places~     a plastic cutting guide on the end of the femur and tibia, so that cuts that do not~     automatically default to the mechanical axis, but rather attempt to recreate the patient's~     anatomic alignment. The surgeon can then assess implant placement and adjust as necessary~     during pre-operative planning. Thus, Patient Specific Cutting Guides give the surgeon better~     control over the placement of the implants.~      This study will be a prospective, randomized evaluation of ShapeMatch Technology for primary~     TKR in a consecutive series of patients who meet the eligibility criteria. The clinical study~     will be accompanied by a formal cost-effectiveness analysis of one-year outcomes.~      One half of the cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee~     System (Triathlon® CR) in a procedure using patient-specific cutting guides designed to~     reproduce the natural kinematic alignment of the knee. The other half of the cases will~     receive the Triathlon® CR device in a procedure using traditional instrumentation, without~     navigation, designed to produce a neutral mechanical alignment. Subjects will be evaluated~     using validated measures within 3 months prior to surgery and at 6 weeks, 3 months, and 1 and~     2 years postoperatively.~      Primary Hypothesis:~      The investigators expect that ShapeMatch Technology will be as cost-effective as usual care.~      Secondary Hypotheses:~      The investigators expect that ShapeMatch Technology will result in improved clinical outcomes~     relative to usual care at three months postoperatively.~      The investigators expect that ShapeMatch Technology will result in similar clinical outcomes~     relative to usual care at two-years postoperatively.~   "
159142|NCT01483053|"~     There is strong evidence that patients with major depressive disorder (MDD) are at increased~     risk of developing coronary heart disease (CHD). This elevated risk is independent of~     classical risk factors such as smoking, obesity, hypercholesterolemia, diabetes and~     hypertension. The risk of CHD is increased 1½-2 fold in those with minor depression and 3-4½~     fold in subjects with MDD. Put simply, the relative risk of developing CHD is proportional to~     the severity of the depression. While the mechanism of increased cardiac risk attributable to~     MDD is not known disturbances in autonomic function most likely do play a part.~      In untreated patients with MDD (with no underlying CHD) the investigators have identified~     that a marked sympathetic nervous activation and diminished heart rate variability (HRV)~     occurs in a proportion (approximately one third) of patients. Diminished HRV has been linked~     to increased incidence rates of acute cardiac events in conditions such as hypertension,~     diabetes and myocardial infarction. Importantly, whether treating depression actually~     improves the risk of: (1) CHD development or (2) recurrence of cardiac events in patients~     with existing CHD remains unknown.~      The investigators, and others, have provided a growing body of evidence linking elevated~     sympathetic activity and exaggerated sympathetic responses to stress to early stages of end~     organ dysfunction and markers of disease development. Of particular note, in addition to~     possible effects on HRV is the association of chronic sympathetic nervous activation to: (a)~     abnormal blood pressure regulation and (b) the development of insulin resistance.~      The investigators therefore plan to examine the cardiovascular effects of two different~     antidepressant medications, agomelatine and escitalopram, in patients with MDD. In addition,~     the investigators plan to investigate the effects these two medications have on sympathetic~     nervous system activity, blood pressure, HRV, endothelial function, metabolic and~     psychological effects.~      Findings from this study will assist us to identify of biological correlates of sympathetic~     nervous activation which will enable us to: (1) identify those at potentially increased~     cardiac risk, and (2) potentially implement additional therapeutic strategies in order to~     reduce cardiac risk. Indeed, it is not known whether antidepressant treatment alone would be~     sufficient to reverse any adverse effects of sympathetic nervous activation. This study aims~     to answer this important clinical question.~   "
159143|NCT01483040|"~     The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video~     monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract~     includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum.~     The device is introduced rectally, as with any standard colonoscope when indications~     consistent with the need for the procedure are observed in the adult patient population.~      The purpose of this prospective clinical study is to establish the usability of the PeerScope~     B System™ when used during standard colonoscopy procedure.~      The study population is comprised of patients indicated for colonoscopy.~      The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary~     endpoints:~        1. The first secondary endpoint is the incidence of complications using the PeerMedical~          colonoscope.~        2. The second secondary endpoint is successful therapeutic interventions as biopsies,~          polypectomies, APC etc.~        3. The third secondary endpoint is the procedure time.~        4. The fourth secondary endpoint is the subjective evaluation of the additional view angle~          by the physician.~        5. The fifth secondary endpoint is patient satisfactory.~   "
159144|NCT01483027|"~     The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal~     cancer with metastases in the liver, who are scheduled to receive second line chemotherapy.~     All patients receive the standard of care chemotherapy with or without the addition of~     TheraSphere.~   "
159145|NCT01483014|"~     This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant~     treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of~     imatinib to convert a tumor from inoperable to operable.~   "
159146|NCT01483001|"~     Lung Cancer (LC), colorectal cancer (CRC) and breast cancer (BC) are the major killers in~     oncology, accounting for about 40% of cancer deaths. Although progresses have been made in~     the last few years, unfortunately no patient with metastatic disease can obtain a definitive~     cure.~      A recent hypothesis is that cancer is driven by a small subpopulation of cells called cancer~     stem cells (CSCs) or tumor initiating cells with an unlimited proliferative potential and~     the ability to reproduce the original human tumor in experimental animal models. These cells~     are thought to be responsible for the development of the tumor and represent the only cell~     population able to sustain tumor growth and progression.~      Therefore, CSCs represent the elective target for new targeted therapies, endowed with high~     and selective toxicity towards the tumor but harmless towards normal cells.~      Current technologies allow us to isolate and expand in vitro the CSCs from tumor specimens,~     testing their sensitivity to different anticancer drugs in a short period of time.~      Therefore, there is the potential opportunity to identify LC, CRC and BC CSCs.This is a~     prospective study assessing feasibility of CSCS isolation in LC, CRC and BC.~      Patients with a previously performed diagnosis of LC, colon cancer or breast cancer with no~     further standard therapy options, with a Karnofsky performance status of 100% and with tumor~     tissue available will be considered eligible for the study. Tumor tissue will be collected~     before study entry, i.e tissue obtained during a diagnostic or therapeutical procedure, like~     surgery or biopsies with other purposes than the protocol. In vitro tumor sensitivity to~     chemotherapy drugs will be tested on tumor cell cultures per each patient.~      Drugs and their combination will be considered effective and if they kill ≥ 60% of tumor stem~     cells in vitro test. By using cancer spheres the investigators will also generate orthotopic~     xenograft models that recapitulate the parental tumor behaviour, including the aggressive~     features and the invasiveness potential. Orthotopic injection technique will be assessed in 5~     weeks-old NOD/SCID mice~   "
159147|NCT01482988|"~     The principal aim of this study is to establish if a polymorphism in a gene important for~     innate immunity to fungi represents a significant risk factor for the development of Candida~     colonisation and subsequent invasive candidosis in critically ill patients. Incorporation of~     a screening programme onto a risk-based algorithm for critical care patients would allow more~     effective targeting of molecular diagnostic tests, anti-fungal prophylaxis and targeted~     treatment. Sequential critical care patients will be screened for gene polymorphisms and~     undergo regular screening for Candida colonization.~   "
159521|NCT01478100|"~     The investigators examined the feasibility of treatment planning using virtual coronary~     revascularization and fractional flow reserve (FFR) CT before the invasive procedures.~   "
159522|NCT01478087|"~     The purpose of this study is to evaluate the clinical safety and feasibility of Mysorba in~     patients with chronic non-ischemic dilated cardiomyopathy (DCM).~   "
159148|NCT01482975|"~     The overarching objective of this research is to prevent substance use in early adolescents~     through the use of innovative interactive interventions tailored to each individual's~     particular risk profile for using cigarettes and alcohol. The specific aims are: (1) To test~     the effectiveness of the computer-based profile-based tailored interventions to keep early~     adolescents smoke-free compared to a comparison group; (2) To test the effectiveness of the~     computer-based profile-based tailored interventions to keep early adolescents from using~     alcohol compared to a comparison group; and (3) To replicate findings that the tailored diet~     and physical activity interventions will be effective in reducing these two high risk~     behaviors as part of the comparison condition.~   "
159149|NCT01482962|"~     This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib~     compared with single-agent treatment, as selected by the investigator from the offered~     options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or~     refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent~     comparator outside the United States of America (USA) as supply was not available.~   "
159150|NCT01482949|"~     The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination~     with sunitinib therapy.~   "
159151|NCT01482936|"~     This is a single center, open label, randomized, parallel group single dose intravenous~     (i.v.) administration study. The subjects will be randomized to receive a single dose of~     OxyNorm® 2.5, 5, and 10mg.~   "
159152|NCT01482923|"~     A treatment session especially for PLWHA to help them discuss and take action about their~     smoking may be useful.~   "
159153|NCT01482910|"~     This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into~     the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual~     function in Chinese subjects with age-related neovascular or wet age-related macular~     degeneration.~      Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both~     treatment groups will receive the other treatment as a sham procedure.~   "
159154|NCT01482897|"~     The specific aim of this study is to determine whether a medical intervention improve status~     of patients with discal sciatica and if yes which type of intervention.~   "
159155|NCT01482884|"~     The study is designed to evaluate the clinical efficacy and safety of tralokinumab as~     compared to placebo. Investigational product will be administered as subcutaneous injection.~     All patients will continue background therapy for ulcerative colitis as per local standards~     of care in addition to investigational product.~   "
159156|NCT01482871|"~     The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal~     injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint~     of this study is observation of dose limiting toxicity and maximum tolerated dose. The~     secondary endpoint of this study is observation of a clinical effect in BCVA (ETDRS letters)~     and OCT central macular thickness.~   "
159157|NCT01482858|"~     This study aims to evaluate the safety and analgesic effect (efficacy) of Gastrolith powder~     (GASP) on skeletal pain caused by osteoporotic vertebral compression fractures (OVCF) versus~     placebo, primarily as assessed by the Numeric Rating Scale (NRS), and Brief Pain Inventory~     (BPI). It is also intended to evaluate disability change with the Oswestry Low Back Pain~     Disability Index (ODI) and to evaluate whether GASP consumption leads to reduction in~     analgesic standard of care (ASOC) versus placebo, using weekly analgesic consumption diaries.~   "
159158|NCT01482845|"~     This study will investigate safety, tolerability and pharmacokinetics of ABT-126 in up to 20~     male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's~     disease on stable doses of acetylcholinesterase inhibitors.~   "
159159|NCT01482832|"~     The Specific Aim of this study is to conduct a randomized controlled trial to evaluate~     whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a~     didactic attention-control program reduces the risk of PPD in adolescent mothers.~      Primary Hypothesis:~        1. The intervention (Project REACH) will be significantly more efficacious than the control~          program in reducing the risk of PPD up to six months postpartum in adolescent mothers.~           Secondary Hypotheses:~        2. The decreased rate of major depression in the Project REACH group compared to the~          control program group will be sustained through one year postpartum.~        3. Adolescent mothers in Project REACH compared to the control program group will have~          higher levels of maternal-child bonding.~   "
159160|NCT01482819|"~     The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial~     bleb response to wearing galyfilcon A lenses in asian eyes.~   "
159161|NCT01482806|"~     Depression and anxiety are common in primary care practice and are associated with~     substantial reductions in health-related quality of life. This Project will test the~     comparative effectiveness of two on-line treatments for these conditions provided through the~     context of a Collaborative Care program: (1) moderated access to a proven-effective~     computerized cognitive behavioral therapy (CCBT) program; versus (2) moderated access to CCBT~     plus an Internet support group (CCBT+ISG). The Project will also compare the effectiveness of~     these treatments to PCPs' usual care for these conditions, and evaluate the adoption and~     maintenance of CCBT+ISG by practices following the conclusion of the trial to provide a~     greater understanding of how to best scale the delivery of these interventions into a variety~     of primary care settings.~   "
159162|NCT01482793|"~     The objective of this study is to gather data regarding the efficacy, safety and~     cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures~     less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all~     vertebroplasties.~      The primary effectiveness analysis will be based on the number of patients whose numeric~     rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks~     post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly~     larger proportion of patients achieving pain reduction than the control group. A secondary~     analysis will compare the change in mean pain scores and specific activity related pain~     scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary~     effectiveness analysis will include the mean change in the back-pain specific limitation in~     function as quantified by the Roland Scale at these same data collection time points.~   "
162304|NCT01441414|"~     To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736)~     in patients that have received one prior systemic regimen for metastatic renal cell carcinoma~     (mRCC) vs. axitinib alone.~   "
159163|NCT01482780|"~     The aim of the study is to analyze the potential of pressure controlled intermittent coronary~     sinus occlusion (PICSO) to prevent/reverse the ischemic burden as well as reperfusion injury.~     To achieve insight into the clinical significance of this local preconditioning effect,~     global hemodynamics, cardiac performance and clinical outcome in the first 30 days will be~     related to the ability of this intervention to protect the myocardium in elective surgical~     procedures, ameliorating cellular decay and preserving the microcirculation therefore~     improving graft flow, reducing enzyme leakage and finally improving myocardial performance.~   "
159164|NCT01482767|"~     Hepatitis C virus (HCV) infection is a leading cause of death and illness in people with~     HIV-1. At the time the study was designed, the standard treatment for people with HIV-1 and~     HCV coinfection included two drugs: pegylated-interferon alfa 2b (PEG-IFN) and ribavirin~     (RBV). The purpose of this study was to evaluate the effectiveness of giving boceprevir (BOC)~     together with standard treatment in treating HCV infection in people with HIV-1 and HCV~     coinfection.~   "
159165|NCT01482754|"~     This is an observational prospective cohort study design to evaluate the safety of rapid~     Rituximab infusion at 90 minutes for Non-Hodgkin Lymphoma (NHL) patients. The secondary aim~     is to measure the number of rejected chemotherapy administration on schedule. Non-Hodgkin~     lymphoma patients who tolerated well for at least 2 cycles of standard infusion of Rituximab~     without grade 3 or 4 adverse events will be recruited in the study. In this study, the first~     20% of the total dose of rituximab will be administered over 30 minutes. When subjects~     tolerate the infusion and stable vital signs, the remaining 80% of the total dose will be~     administered over 60 minutes. Prior administration of Rituximab, premedication will be given~     to the subjects including PO Paracetamol 1g, IV Diphenhydramine 25/50mg and/or IV~     Hydrocortisone 100mg. The duration of subjects involvement in the study approximately takes~     72 hours. Adverse events that occur within the first 24 hours of infusion will be evaluated~     if related to Rituximab infusion as some subjects are receiving combination chemotherapy with~     rituximab. This study will recruit both in patients and out-patients. A phone call to monitor~     subject's health will be made post 24, 48, 72 hours of rituximab infusion. The findings from~     this study will add evidence to the safety of rapid Rituximab infusion at 90 minutes. If the~     outcome is favourable, NUH will consider adopting the new infusion rate for Rituximab~     infusion for patients who tolerated at least 2 cycles of standard infusion recommended by the~     drug manufacturer.~      The study hypothesizes that rapid Rituximab infusion at 90 minutes is safe for NHL patients.~   "
159166|NCT01482741|"~     Risks from imaging-related radiation exposure have become a popular topic in the media.~     Because these tests are commonly applied to patients at a cancer center, it is important to~     understand what patients know, how they feel about what they know, where they get their~     information, and how satisfied they are with available risk-benefit communication on this~     topic.~      The purpose of this study is to understand how cancer patients perceive risks and benefits of~     diagnostic radiation and their satisfaction with healthcare communication on this topic.~   "
159167|NCT01482728|"~     The purpose of this study is to see if the investigators can measure inhibition of a protein,~     Src (named for Sarcoma), in tissue and blood in patients with a diagnosis of endometrial~     cancer. Dasatinib is a drug that blocks the activity of an important protein in cancer cells~     called Src. The investigators can measure the blocking of Src in the bloodstream. However,~     the investigators do not know if measures in the bloodstream reflect blockage of Src in~     cancer tissue. The investigators are doing this study to try and see if the investigators can~     match what the investigators see in cancer tissue to what the investigators see in the~     bloodstream. the investigators hope that in the future, the investigators can use blood to~     measure protein inhibition by dasatinib instead of asking patients to undergo repeat~     biopsies.~   "
159168|NCT01482715|"~     Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate~     the safety of different doses and dosing regimens of oral rucaparib administered daily to~     patients with solid tumors.~      Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the second~     part of the study is to determine the safety and clinical activity of the RP2D of oral~     rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or~     somatic).~      Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further~     evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid~     tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).~   "
159169|NCT01482702|"~     Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese.~     The American Cancer Society has called for weight loss treatment to be standard of care for~     overweight women with breast cancer. During therapy women with breast cancer often gain~     weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have~     their cancer come back. The reason why overweight breast cancer survivors are more likely to~     re-occur has not been well studied, but changes in how insulin works may contribute.~     Overweight survivors are also at risk for the other chronic diseases associated with obesity.~     Fortunately, weight losses of as little as 5-7% of baseline body weight can improve risk of~     chronic disease. An effective behaviorally-based, lifestyle intervention delivered via the~     internet has been developed at the University of Vermont. This successful intervention has~     not been tested among breast cancer survivors. Given that women tend to lose muscle mass~     during cancer therapy the addition of a resistance training component to the weight loss~     intervention may be important. Therefore the overall goal of this project is to pilot test a~     proven distantly- delivered behavioral weight loss intervention among overweight breast~     cancer survivors and to evaluate whether a resistance program results in improvements in lean~     body mass, while studying how both interventions change insulin sensitivity.~      Specifically, this project is a randomized, controlled clinical trial designed to test the~     effectiveness and acceptability of a 6-month behavioral weight loss intervention with and~     without resistance training. Participants will be randomized to one of two groups: 1)~     behavioral weight control treatment via the Internet; or 2) behavioral weight control~     treatment via the Internet plus a resistance training program. Women eligible to participate~     include overweight breast cancer survivors who are age 50 or older and 6-36 months past~     receiving chemotherapy. Assessments will be conducted at baseline and six months and will~     include measures of body weight, muscle mass, adherence to treatment, and insulin~     sensitivity.~   "
159170|NCT01482689|"~     The main aim of the present study is to compare the bioavailability of vitamin D from cod~     liver oil and multivitamin tablets given to healthy individuals under the same conditions, as~     well as to study the influence of gender and ethnicity on vitamin D absorption. Healthy~     subjects will be randomised into two parallel groups receiving 10 micrograms (400 IU) per day~     of vitamin D3 from one fish oil capsule or one solid multivitamin tablet, respectively. Serum~     samples will be drawn at baseline and after four weeks (28 days) for the analysis of~     25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone, and tartrate resistant~     acid phosphatase in serum.~   "
159526|NCT01478035|"~     To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in~     patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin~     will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50~     yrs.~   "
159171|NCT01482676|"~     Urgency, frequency and incomplete emptying are the key symptoms of lower urinary tract~     dysfunction, including bladder pain syndrome/interstitial cystitis, and overactive bladder~     syndrome. Lower urinary tract dysfunction is associated with cellular stress, leading to~     changes in gene expression and consequent organ remodeling. MicroRNAs are small regulatory~     molecules, affecting protein synthesis. They are quickly winning recognition as potential~     therapeutic agents. The investigators will perform a comparative study of mRNAs changed in~     lower urinary tract dysfunction and address the role of differentially expressed miRNAs in~     regulation of the genes, important for bladder function. The experimental approach, combining~     the analysis of human biopsy material with the in vitro cell-based models, will allow the~     investigators to elucidate the effects of miRNAs on the expression of receptors, contractile~     proteins and tight junction proteins. Once the disease-induced miRNAs have been characterised~     and their target genes validated, it will be possible to influence their expression levels~     thus counter-acting their effects.~      The investigators' work addresses fundamental mechanisms of signal transduction in urothelium~     and smooth muscle during cellular stress caused by inflammation or bladder outlet~     obstruction, and its regulation in the diseased state. The investigators' findings will~     further the knowledge of the molecular mechanisms of lower urinary tract dysfunction and have~     implications for diagnosis and treatment. Additionally, they have relevance for other~     clinical conditions, where miRNAs are implicated.~   "
159172|NCT01482663|"~     Hand eczema is a common disease which often gives a chronic course thus affecting many~     functions in daily life. The body of evidence related to self-management of chronic hand~     eczema is poor. Better methods to support self-management of patients with chronic hand~     eczema may potentially improve the prognosis of a disease which is both a tremendous burden~     to the individual and to the society. The purpose of this trial is to evaluate the effect of~     a newly designed guidance programme offering individual counselling compared to conventional~     information with written information sheets.~   "
159173|NCT01482650|"~     The investigators have performed a number of studies on novel airway devices, including an~     observational study on the performance of a new supraglottic airway named Baska mask. In this~     new proposed study the investigators would like to compare directly,in a randomized clinical~     trial, this device with the device the investigators routinely use - the single use laryngeal~     mask airway - LMA, in female patients undergoing general anaesthesia.~      This study will determine which device performs best, as measured by key parameters~     (insertion success rate, seal pressures, time to and ease of insertion, failure rate,~     complications etc) as regarding the performance and safety profile of the Baska mask and the~     LMA.~      The investigators have two study hypotheses, namely (1) non-inferiority of first placement~     attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs LMA.~      A number of secondary endpoints will be monitored and analyzed (time to and ease of~     insertion, failure rate, complications etc).~   "
159174|NCT01482637|"~     In this study, the investigators seek to further develop the CAS as a comprehensive,~     reliable, and valid instrument for measuring coercion to participate in research among adult~     substance abusing offender populations.~   "
159175|NCT01482624|"~     The primary objective of this clinical investigation is to determine whether~     post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can~     relief pain, improve mobility and promote joint recovery, compared to the standard~     arthroscopy procedure alone, in patients undergoing arthroscopic procedure.~   "
159176|NCT01482611|"~     The purpose of this study is to investigate the safety, tolerability and plasma~     pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food)~     from 10 mg up to 600 mg or up to the maximum tolerated dose or up to the dose that yields a~     JNJ-47910382 plasma level that approaches the predefined maximum mean exposure (whichever~     comes first) in healthy Caucasian and Japanese participants. The foreseen maximum dose is 600~     mg. In addition, the effect of fasting (ie JNJ-47910382 is taken without food) on the plasma~     pharmacokinetics of JNJ-47910382 after one selected oral dose given to healthy Caucasian~     participants will be studied. JNJ-47910382 is a drug that is being developed to treat~     Hepatitis C infection and is an inhibitor of the reproduction machinery of the Hepatitis C~     virus (HCV). Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream,~     distributed in the body and eliminated from the body.~   "
159177|NCT01482598|"~     The Study Purpose is to demonstrate the superiority of optimized remote patient management~     compared to optimized standard care in the management and prognosis of heart failure, in the~     prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the~     reduction of inappropriate shock therapies. The remote care allows early intervention in~     terms of drug therapy adjustment and cardiac resynchronization therapy (CRT‐D) device~     reprogramming.~   "
159178|NCT01482585|"~     to determine the values of imaging and genetic biomarkers for prediction of tumor~     aggressiveness and prognosis in patient with early stage lung adenocarcinoma to Identify~     unique copy number alteration in patient with early stage lung adenocarcinoma to evaluate the~     long-term change of ground-glass nodule combined with lung adenocarcinoma to suggest a~     guideline for planning an appropriate follow-up examination and management~   "
159179|NCT01482572|"~     The purpose of this study is to evaluate the feasibility of aspiration samples for mutational~     analysis in patients with a non-small cell lung cancer (NSCLC).~   "
159180|NCT01482559|"~     The HIP trial is a large pragmatic, multinational, randomised trial of two different~     strategies for the management of hypotension in extremely low gestational age newborns~     (Standard with dopamine versus a restricted with placebo approach).~      HYPOTHESIS: A restricted approach to the management of hypotension in extremely low~     gestational age newborns will result in improved neonatal and long-term developmental~     outcomes.~      PRIMARY OBJECTIVE: To determine whether a restricted approach to the management of~     hypotension compared to using dopamine as first line pressor agent in infants born less than~     28 weeks of gestation within the first 72 hrs after birth (transitional period), improves~     survival without significant brain injury at 36 weeks postmenstrual age (PMA) and improves~     survival without moderate or severe neurodevelopmental disability at 2 years corrected age.~   "
159527|NCT01478022|"~     This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200~     and IBU and ISO combinations (200 +20) given in single dose.~      This study is being conducted to support the submission for new indication in treatment of~     the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular~     dystrophy.~   "
159181|NCT01482546|"~     Hypothesis: Novice trainees will achieve significantly higher clinical competence and patient~     satisfaction scores with the use of warm water infusion method when compared with traditional~     air insufflation~      Primary outcome: adenoma detection rate~      Secondary outcomes: (1) independent cecal intubation rate, (2) trainer assessment of~     trainee's colonoscopy skills, (3) trainee's assessment of clinical confidence, (4) procedural~     medication requirement, (5) patient pain level during procedure, (6) patient satisfaction at~     procedure completion, and (7) patient willingness to repeat procedure'~      Specific Aim: To demonstrate the stated hypothesis via above outcome measures. The long term~     goal is to provide evidence to influence other training institutions to consider education in~     the warm water infusion method'~   "
159182|NCT01482533|"~     The main purpose of this study is to compare the effectiveness and accuracy of tissue~     cultures and swab cultures to diagnose prosthetic joint infection.~   "
159183|NCT01482520|"~     All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted~     therapy will be candidates for the study.~      No additional treatment or intervention will be conducted except for blood sampling that will~     be limited to one time only.~      Blood samples (10 cc in volume) will be collected from all study participants once they~     provided written informed consent form. DNA will be extracted from peripheral blood samples~     using DNA isolation kit.~   "
159184|NCT01482507|"~     Diffusion Weighted Imaging (DWI) MRI will assist in differentiating poor prognosis bone~     oedema more effectively than traditional T2 weighted MRI in patients with early Rheumatoid~     Arthritis (RA).~   "
159185|NCT01482494|"~     The adult onset form can occur between the second and sixth decades of life as a form of~     proximal myopathy, predominantly in the pelvic girdle area. Sometimes the first symptoms are~     shortness of breath and diaphragm weakness which herald progressive proximal muscle weakness.~     The heart and liver are not affected.~      Serum CK (Creatine Kinase) activity is 2 to 10 times higher than normal. EMG (electromyogram)~     testing usually reveals a myopathic pattern and muscle biopsy may show vacuoles containing an~     accumulation of glycogen that is not broken down.~      Until fairly recently, an assay of acid maltase activity using cultured fibroblasts after~     biopsy of skin or muscle tissue was required for diagnosis, as leukocytes contain a renal~     isoenzyme that is not absent in these patients and which can mask the deficit and result in~     false negatives. In recent years this problem has ben solved by the introduction of acarbose,~     an inhibitor of renal α-glucosidase; it is also used in the dried blood spot method, which~     measures acid maltase activity using maltose and acarbose as inhibitors and~     4-methylumbelliferyl-D-glucopyranoside as substrate.~   "
159186|NCT01482481|"~     Background: Nurses in clinical practice implement care to patients with Type 2 diabetes~     mellitus (DM2) in order to maintain normal blood glucose readings, promote weight loss and~     provide nutrition counseling to improve metabolic and blood pressure control. Because many~     disciplines contribute to patient's health outcomes, it is important to distinguish how~     nurses contribute to patient care and the achievement of health outcomes and the differences~     between the use or not the classification of Nursing Diagnoses, and the Nursing Interventions~     Classification (NIC) in clinical practice settings.~      Methods: Prospective observational study with 2-year follow-up to assess the effect of~     Nursing Care Plans based on Scientific Methodology (NCPSM) on changing the control parameters~     in routine clinical practice conditions.~      Settings: 31 Primary care centers in northeastern urban area of Madrid (Spain). Subjects:~     24,124 DM2 patients (full universe).~   "
159187|NCT01482468|"~     The purpose of this study is to determine whether continuous infusion of palonosetron after~     its prophylactic single injection can further reduce the incidence of postoperative nausea~     and vomiting in patients undergoing gynecological laparoscopic surgery.~   "
159188|NCT01482455|"~     There is a current debate whether impaired insulin-mediated microvascular perfusion limits~     the delivery of hormones and nutrients to muscle and whether short term FFA elevation affects~     transcapillary transport of insulin and glucose thereby representing a rate-controlling step~     for insulin-stimulated muscular glucose disposal in humans.~      To address these questions, the investigators determined the changes of interstitial glucose~     and insulin in skeletal muscle of healthy volunteers during intravenous administration of~     triglycerides or glycerol under physiologic and supraphysiologic hyperinsulinemic conditions.~   "
159189|NCT01482442|"~     The purpose of this study is to determine whether RADIOEMBOLIZATION with 90 Yttrium~     microspheres is more effective on overall survival in advanced Hepatocellular carcinoma (HCC)~     with or without portal venous obstruction and no extrahepatic extension than sorafenib which~     is now the standard treatment of advanced HCC.~   "
159190|NCT01482429|"~     Prolongation of mechanical ventilation poses serious personal and financial threats to~     healthcare consumers.~      The investigators objectives are create and implement an multidisciplinary evidenced-based~     ventilator-weaning protocol to assess whether a systematic approach compared with the~     physician's judgment only decreases time spent on the ventilator, complications of mechanical~     ventilation and length of stay in critical care unit.~   "
159191|NCT01482416|"~     The aim of this study is to evaluate the vascular effects of estrogens on climacteric women~     measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound~     and compare to placebo.~   "
159192|NCT01482403|"~     This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will~     evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in~     combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C~     infection. The anticipated time on study treatment is up to 48 weeks.~   "
159193|NCT01482390|"~     This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained~     virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with~     telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with~     chronic Hepatitis C infection.~   "
159421|NCT01479413|"~     The investigators will investigate~        1. the relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA~          copy numbers and the clinical psychopathology of schizophrenia, including severity of~          positive and negative symptoms, obesity and metabolic syndrome.~        2. the relationships between aberrant mitochondria genes (single nucleotide polymorphism of~          D-loop region-related genes and haplogroup N9a), DISC1 gene polymorphism, and clinical~          phenotypes in Taiwanese populations.~        3. whether these biological markers could be as clinical markers in schizophrenia for a~          long-term follow-up study.~   "
159194|NCT01482377|"~     This dose-escalating study consists of 3 parts (A, B and C) and will evaluate the safety,~     pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or~     erlotinib, in participants with metastatic and/or locally advanced malignant HER3-positive~     solid tumors. Cohorts of participants will receive escalating doses of intravenous RO5479599~     as monotherapy (Part A) or in combination with cetuximab (in Part B) or with erlotinib (in~     Part C) followed by an extension phase for each part.~      In an imaging substudy, participants will receive one or two doses of zirconium-89-labeled~     RO5479599 (89ZrRO5479599) in addition to unlabeled RO5479599 to evaluate the in vivo~     biodistribution and organ pharmacokinetics of RO5479599.~   "
159195|NCT01482364|"~     The purpose of this study is to demonstrate that monitoring hemodynamic parameters and then~     applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management -~     IHM) improves the control of systolic blood pressure (SBP) at ambulatory blood pressure~     monitoring (ABPM) in hypertensive patients, as compared to classical drug selection (i.e.~     without IHM) during a 6 months intensive treatment program.~   "
159196|NCT01482351|"~     The goal of the research is to determine the power and the feasibility of the study design~     and methods to inform a full-scale clinical trial that will determine whether treatment of~     obstructive sleep apnea in older adults with mild cognitive impairment delays cognitive~     decline and preserves everyday function.~   "
159197|NCT01482338|"~     The purpose of this study is to determine whether low-dose combine oral contraceptives (COC)~     containing desogestrel 150 mg and drospirenone 3 mg are effective in the treatment of~     Premenstrual symptoms.~   "
159198|NCT01482325|"~     The primary objective of this study is to show that the noninvasive blood pressure software~     algorithm meets engineering requirements.~   "
159199|NCT01482312|"~     The purpose of this study is to evaluate two different types of contact lenses and their~     effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.~   "
159200|NCT01482299|"~     This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free~     survival rate (primary end-point) and response rate, toxicity, overall survival and biomarker~     assessment (secondary end-points) in patients with metastatic or recurrent gastric cancer~     with pS6 Ser 240/4 expression.~      Eligibility criteria include pathologically proven non-resectable adenocarcinoma of stomach~     with measurable disease who failed previous first-line palliative chemotherapy including~     fluoropyrimidine and platinum with high expression of pS6 Ser 240/4.~      Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted~     according to the observed clinical toxicities. Treatment will be continued until disease~     progression or patient's intolerability to the study drug.~      A study requires 40 assessable subjects to decide whether the proportion of patients who are~     free from progression at 4 months (16 weeks), P, is less than or equal to 0.1 or greater than~     or equal to 0.25 with a target error rate of 0.05 and β of 0.2. If the number of responses is~     7 or less, the hypothesis that P >= 0.250 is rejected with a target error rate of 0.200 and~     an actual error rate of 0.182. If the investigators assume that drop-out rate is 10%, total~     accrual patient will be 45.~   "
159201|NCT01482286|"~     Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of~     reproductive age and despite decades of research the etiology the disorder is not known. The~     characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine~     function and insulin resistance. Obesity is a common correlated phenotype of Polycystic ovary~     syndrome and weight gain worsens the reproductive and metabolic complications. Currently~     there is no evidence-based treatment plan for infertility in Polycystic ovary syndrome; yet~     weight loss by dietary restriction and regular exercise are strongly advocated. Weight loss~     and increased insulin sensitivity appear to drive improvements in reproductive outcomes in~     women with Polycystic ovary syndrome; however, the mechanism connecting these changes with~     the reproductive axis is not fully understood.~   "
159202|NCT01482273|"~     Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for~     developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to~     more distal DVT. There's evidence that the early removal of the obstructing thrombus by~     catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher~     degree of thrombolysis is associated with lower incidence of PTS, better quality of life and~     lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced~     thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency,~     low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs~     accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however~     the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally~     assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis~     reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic~     ilio-femoral DVT.~   "
159203|NCT01482260|"~     Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous~     malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression~     profiling using microarrays.~   "
159204|NCT01482247|"~     The purpose of the study is to employ the supplement L-arginine to test the hypothesis that~     activation of blood flow to the brain during cognitive tasks is regulated by nitric oxide in~     older subjects with diabetes mellitus and/or hypertension (high blood pressure).~   "
159205|NCT01482234|"~     The purpose of this study is to assess whether text messages can be used as a way to increase~     the amount of physical activity teens get each day.~   "
159206|NCT01482221|"~     The purpose of this study is to assess the effect and safety of AZD6765 in patients with~     major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a~     channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.~   "
159207|NCT01482208|"~     Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration~     status in newborns and infants by means of ultrasound velocity measurements through muscle~     tissues. Changes of tissue hydration will be followed during first days of life in newborns~     and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical~     dehydration symptoms will be used as controls.~   "
159422|NCT01479400|"~     The primary aim of this prospective study is to evaluate the effect of antipsychotics on~     infant development especially neurobehavioral development which evaluated by the Bayley-III~     when mothers are treated with antipsychotics throughout their pregnancy.~   "
159208|NCT01482195|"~     A recombinant adeno-associated virus serotype 2 (rAAV2) vector has been altered to carry the~     human MERTK (hMERTK) gene. This vector has been shown to restore vision in animal models that~     resemble human MERTK-associated Retinitis Pigmentosa (RP), an incurable retinal degeneration~     that causes severe vision loss. The proposed study is an open label, Phase I clinical trial~     of subretinal rAAV2-VMD2-hMERTK administration to individuals with MERTK-associated retinal~     disease. This trial will lead to a greater understanding of the safety and thereby potential~     value of gene transfer in MERTK-associated retinal disease and will have implications for~     other forms of retinal degenerative disease amenable to this type of intervention.~   "
159209|NCT01482182|"~     In this prospective study, the investigators will evaluate and compare the usefulness of~     functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the~     palliative chemotherapy with the aim of predicting tumor response and prognosis in patients~     with advanced Non-small Cell Lung Cancer (NSCLC).~   "
159210|NCT01482169|"~     The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to~     intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.~   "
159211|NCT01482156|"~     Study has two parts:~        1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety~          and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in~          patients with advanced solid tumors.~        2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in~          patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer~   "
159212|NCT01482143|"~     The aim of this study is to characterize the pharmacokinetics and safety/tolerability of~     AFQ056 in children with Fragile X Syndrome(FXS)~   "
159213|NCT01482130|"~     The current guidelines emphasize the prevention of bone loss, by building up bone mass in~     young age, as one of the most important measures to reduce the incidence of osteoporosis.~     Strength training and explosive exercises have been shown to have beneficial effects on~     bone mass and bone metabolism in both young and postmenopausal women. However, meta-analysis~     concludes that it is still unclear what type of exercises, intensity and execution that is~     most effective for skeletal adaptations. The following study will examine the effect of 12~     weeks of heavy, explosive strength training on bone mineral density and bone metabolism in~     young, healthy girls aged 18-30 years.~   "
159214|NCT01482117|"~     The aim of this study is to investigate the effects of genetic polymorphisms on~     pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean~     healthy adult volunteers.~   "
159215|NCT01482104|"~     Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a~     slow-growing tumour which despite low metastatic potential may cause significant local tissue~     destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy~     (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week~     apart. This procedure is considered quite time- and resource-consuming. Introducing a single~     treatment session, with a new PDT session for treatment failures after 3 months, might~     represent an attractive simplification.~      This randomised controlled single-blinded multi-centre study primarily aims to compare BCC~     lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with~     re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard~     Metvix(R) PDT treatments 1 week apart.~      Secondary objectives are to investigate the treatment response in relation to clinical and~     histological tumour characteristics such as tumour thickness, subtype and immunohistochemical~     markers.~   "
159216|NCT01482091|"~     The purpose of this study is to determine if intranasal fentanyl can decrease the pain of~     patients with sickle cell disease who present to the pediatric emergency department with a~     vaso-occlusive crisis.~   "
159217|NCT01482078|"~     Magnesium is a treatment for mothers to protect brains of babies born early. This study~     investigates combined effects of magnesium and spinal or epidural anesthesia on mothers~     having cesareans.~      The investigators will use a scoring system to measure sedation and devices that subjects~     breath in and out of to measure breathing strength.~      The investigators hypothesize the combination of magnesium and anesthesia will reduce~     breathing strength and cause sedation.~      This is an observational study comparing those having magnesium and anesthesia with those~     just having anesthesia. Routine medical care will not be altered.~      Results will hopefully allow anesthesiologists to provide better patient care.~   "
159218|NCT01482065|"~     This research is being done to examine: 1) how common obstructive sleep apnea (OSA) is in~     patients with non-alcoholic fatty liver disease (NAFLD), 2) whether the severity of OSA is~     related to the severity of NAFLD, and 3) whether treatment of OSA with continuous positive~     airway pressure (CPAP) improved NAFLD progression.~      OSA is a condition caused by repetitive collapse of throat tissue during sleep that leads to~     falls in oxygen level and sleep disruption. OSA can be caused by obesity, and especially by~     fat found in the neck and belly.~      NAFLD is a common disease linked to obesity. NAFLD is part of a disease spectrum, which can~     progress from steatosis (fatty liver) to nonalcoholic steatohepatitis (NASH), a progressive~     fibrotic disease, in which cirrhosis and liver-related death can occur. Recent evidence in~     patients with obstructive sleep apnea (OSA) indicates that OSA is associated with NASH. How~     common OSA is in patients with biopsy-confirmed NAFLD and the effect of OSA treatment with~     CPAP on NASH is unknown.~   "
159219|NCT01482052|"~     The purpose of this study is to evaluate the safety of a new conjugate vaccine,~     NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal~     A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of~     antibodies to of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine,~     as a measure of vaccine effectiveness.~   "
159281|NCT01481246|"~     The Neurocognitive Study for the Aging (NEUROAGE) was initially funded by the Cyprus Research~     Promotion Foundation and has received subsequent funding by the European Union Regional~     Development Fund. The project focuses on the understanding of the effects of age on~     neurocognitive abilities such as attention, memory, language, categorization, and executive~     functioning. In addition, specific arms of the project investigate the effects of a~     theory-driven hierarchical training program, the Categorization Program, to improve cognitive~     abilities in adults with Mild Cognitive Impairment (MCI). Over 800 adults ages 40 and older~     have been recruited in the NEUROAGE project thus far. The grant was awarded to the University~     of Cyprus.~   "
159220|NCT01482039|"~     The investigators propose a prospective evaluation of methods to assess cervical length for~     uncomplicated singleton gestations between 18-28 weeks presenting to the MFM office for~     routine mid pregnancy ultrasound. The investigators hypothesize that a sequential approach to~     screening of the cervix (which consists of initial transabdominal evaluation first with~     transvaginal ultrasound reserved only for those patients in whom the cervix appears short on~     transabdominal exam or when adequate views cannot be obtained with the transabdominal~     approach alone) will take less time, will result in the same number of adequate views of the~     cervix and will have higher patient satisfaction that a universal transvaginal screening~     approach.~      OBJECTIVE~      To determine the best strategy for cervical length screening in uncomplicated singleton~     gestations between the gestational ages of 18-28 weeks.~      Primary outcome:~      1) Time required to obtain adequate views of the cervical length.~      Secondary outcomes:~        1. Patient satisfaction with ultrasound experience as measured by patient questionnaire~        2. Number of adequate views of the cervix obtained with each approach~      STUDY DESIGN~      This is a prospective study to compare strategies for cervical length measurements in~     uncomplicated singleton gestations seen in the MFM office for routine mid pregnancy fetal~     well being ultrasound between 18-28 weeks gestation. The different strategies include 1)~     Transabdominal assessment of the cervix (current standard), 2) Sequential evaluation of the~     cervical length (transabdominal followed by transvaginal if necessary due to short cervix or~     inadequate transabdominal views), and 3) Transvaginal cervical length assessment. Patients~     with an uncomplicated singleton gestation presenting for a routine mid pregnancy ultrasound~     between 18-28 weeks will be randomized into one of the three groups noted above after consent~     is obtained. Ultrasound examination will then take place and data collected. The various~     strategies listed above will be compared for the following:~        1. Time required to obtain views of the cervix~             1. Time from initiation of exam to completion of cervical assessment~             2. Time for completion of entire exam~        2. Patient satisfaction~             1. Comfort/Discomfort of exam procedure~             2. Overall impression of exam process~        3. Number of adequate views of the cervix obtained~      Maternal demographics including age, parity, weight, height and due date/gestational age will~     also be obtained for all consenting patients.~   "
159221|NCT01482026|"~     The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients.~     Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for~     one of the most important in terms of frequency and psychosocial and educational~     consequences.~      In these conditions, our study was designed to estimate the sensitivity to changes of the~     different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will~     then optimize our methodological approach for a therapeutic trial.~   "
159222|NCT01482013|"~     This is a safety and tolerability study investigating the effect of HPP854 in subjects with~     mild cognitive impairment or a diagnosis of mild Alzheimer's disease. The study will assess~     the pharmacokinetic and pharmacodynamic relationships of HPP854 in plasma, pharmacodynamic~     relationship in cerebral spinal fluid and plasma concentration profiles for Amyloid-Beta.~   "
159223|NCT01482000|"~     The purpose of this study is to compare the exercise capacity and pulmonary function test~     parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care~     with and without pulmonary daoyin therapy of China in community.~   "
159224|NCT01481987|"~     Purpose: To evaluate macular sensitivity and its correlation with visual acuity and Spectral~     Domain Optical Coherence Tomography (SD-OCT) in eyes with idiopathic epiretinal membrane~     (ERM).~      Design: Cross sectional case-control series.~      Methods:~      Setting: Dijon University Hospital. Patients: Forty nine patients (49 eyes) with idiopathic~     ERM and twenty-seven healthy patients (27 eyes) as a control group.~      Main outcome measurement: Microperimetry, Spectral Domain Optical Coherence Tomography~     (SD-OCT).~   "
159225|NCT01481974|"~     The overall purpose of this study is to evaluate the safety, pharmacokinetics and preliminary~     efficacy of a five-days post-operative course of Treprostinil in liver transplant patients.~      The hypothesis of this study is that Treprostinil can be safely administered post-operatively~     in liver transplant patients. Once safety is documented future studies will address its~     ability to ameliorate or prevent reperfusion mediated dysfunction of the liver graft and~     thereby reduce morbidity, leading to shorter hospital stays as compared to historical~     controls.~   "
159226|NCT01481961|"~     The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS)~     applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early~     Alzheimer's disease (AD).~      This study included 15 patients treated with rTMS and whose medication reference is~     stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected~     in the MCRR of Besançon and the psychiatric department of the University Hospital of~     Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using~     the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS),~     State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety~     Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized~     by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued~     Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test~     (STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96),~     Rey-complex figure test-copy and Picture naming 80 items test (DO80).~      Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25~     seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A~     psychometric assessment will be conducted again at the end of treatment week and one month~     after stopping treatment. A neuropsychometric assessment will be conducted one month after~     stopping the treatment. Scales of comfort and acceptability will also be proposed to the~     patient to determine whether any gene is caused by this treatment. Moreover a questionnaire~     will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and~     4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy~     Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily~     Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of~     recent change of the personality (CP6).~      The population of this study will be comprised of patients between 60 to 85 years-old with~     early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be~     recruited on a voluntary basis, after notification and consent in the research center. This~     study was conducted over a period of 15 months.~   "
159227|NCT01481948|"~     The purpose of this project is to reduce health disparities in obesity risk among 8-10 year~     old African American girls using a culturally sensitive and developmentally appropriate~     internet-based program with no face-to-face interaction. This study will conduct an outcome~     evaluation to test short and longer term effects on obesity risk.~   "
159228|NCT01481935|"~     The purpose of this study is to determine whether extra cleaning of frequently-contaminated~     surfaces in intensive care rooms is effective in preventing contamination of disposable~     isolation gowns and gloves with multi-drug resistant bacteria.~   "
159229|NCT01481922|"~     This study is intended to help guide the choice of needle diameter when performing a lumbar~     puncture.~      Smaller spinal needles have been shown to decrease rate of adverse events such as post-lumbar~     puncture headache and hearing loss.~      The main drawback to using smaller needles is diminished flow rate; some textbooks recommend~     using needles no smaller than 22 gauge because of the slow flow rate though others recommend~     smaller needles, namely 22-24 gauge.~      Some authors have described a successful use of spinal needles as small as 25 gauge when~     performing a lumbar puncture.~      The investigators do not believe that the flow-rate difference between 22 and 24 gauge~     needles is significant enough to justify using the larger needles.~      The investigators trial will compare the Whitacre 22 gauge and Whitacre 24 gauge needles for~     flow rate, and incidence of the known complications of pain during procedure and backache at~     8 and 15 days post-procedure.~      The investigators will also look at whether smaller needles are associated with less pain~     during the procedure and less backache the next 2 weeks after the procedure.~   "
159282|NCT01481233|"~     The purpose of this study is to determine the prostate specific antigen response to~     continuous low dose oral colchicine.~   "
159230|NCT01481909|"~     Study title:~      An exploratory, randomised, double-blind, placebo controlled crossover study to assess the~     efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms.~      Study code:~      SMART-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to § 40~     Abs. 4 AMG) Dr. med. F. Siebenhaar, Prof. Dr. Med. M. Maurer, Allergie-Centrum-Charité,~     Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1,~     D-10117 Berlin Biometry and biostatistical analyses Division of Biostatistics and Clinical~     Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Monitoring~     Coordination Centre for Clinical Studies (KKS), Charité - Universitätsmedizin Berlin,~     Charitéplatz 1, D-10117 Berlin Clinical phase Phase II~      Primary objective:~      Reduction of wheal and flare type skin reaction after standardised provocation testing~     assessed by volumetric and thermographic measurements.~      Secondary objectives:~      Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as~     assessed by symptom score, DLQI, Itchy-QoL and VAS.~      Study design:~      An exploratory, randomised, double-blind, placebo controlled crossover study~      Type and number of patients:~      Male and female patients (n = 30) with cutaneous mastocytosis and indolent systemic~     mastocytosis with skin involvement~      Main criteria for inclusion:~      Mastocytosis patients aged 18-65 years, signed written consent, no systemic corticosteroid or~     other immunosuppressive therapy, no permanent severe diseases Test product, dose and mode of~     administration 20 mg Rupatadine or placebo before provocation testing, oral administration~     (tablets)~      Duration of treatment:~      28 days (testing will be done at the day of last treatment)~      Assessment of efficacy:~        1. Assessment of wheal and flare development by planimetric analyses of digital~          photographic, volumetric, and thermographic imaging (time lapse) before and after~          treatment with study medication,~        2. Additional assessment of symptoms,~        3. Assessment of life quality~      Main criteria of evaluation:~      Efficacy~   "
159231|NCT01481896|"~     This retrospective study will review the Anderson Orthopaedic Institute's initial experience~     among a consecutive series of 126 patients who had primary total hip arthroplasty using a~     metal-on-metal articulation consisting of a DePuy Pinnacle cup with an Ultamet liner coupled~     with a 36-mm cobalt-chrome alloy femoral head. The relationship between metal ion levels, cup~     orientation, osteolysis, radiographic implant stability and clinical outcome measures~     including component revision, complications, patient satisfaction and Harris Hip Scores will~     be evaluated.~   "
159232|NCT01481883|"~     The aim of this project is to investigate the effect of Raloxifene 120mg in men with~     schizophrenia. This trial will adopt a 12 week randomised controlled model.~      Hypotheses 1: That the men receiving adjunctive selective estrogen receptor modulators (SERM)~     will have a significantly greater reduction in psychosis symptoms over the course of the~     study than men receiving adjunctive placebo.~      Hypotheses 2: That the men receiving adjunctive SERM will have a significantly greater~     improvement in cognitive function than men receiving adjunctive placebo~   "
159233|NCT01481870|"~     The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with~     cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve~     progression free survival and overall survival in a comparative study with interferon-alpha.~     When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is~     one of the treatment options after disease progression. Reversely, when sorafenib is used as~     first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of~     cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this~     study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy~     and treatment switched to the other test drug, sorafenib or sunitinib, when disease~     progression is detected to assess which treatment sequence produces longer progression free~     survival and offers a better safety profile (causing fewer adverse events). The purpose of~     this trial is to compare progression free survival of first line sunitinib versus sorafenib,~     and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib~     followed by sunitinib.~   "
159234|NCT01481857|"~     Proprioceptive training has been shown to be effective in increasing the efficiency of~     motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that~     proprioceptive support do influence in the activation of the transversus abdominis muscle~     (TrA) during segmental stabilization training.~   "
159235|NCT01481844|"~     The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI +~     amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and~     tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole +~     tetracycline ) as second line treatment of H. pylori .~   "
159236|NCT01481831|"~     This purpose of this study is to evaluate the efficacy and safety of single and repeated~     doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and~     highly emetogenic chemotherapy in patients.~   "
159237|NCT01481818|"~     Radiodermatitis and radiation mucositis were the most frequent side-effect during the course~     of radiotherapy, especially when concurrent chemoradiotherapy applied. Since reactive oxygen~     species formed upon radiation therapy play a central role in initiating and driving the~     detrimental signaling events, antioxidant supplementation is thought to provide a~     photoprotective effect against radiation. Green tea extract has been shown to have~     antioxidant and anti-inflammatory effects on various types of cells. To evaluate the safety~     and efficiency of green tea extract in the treatment of radio dermatitis and radiation~     mucositis, the investigators conducted this phase Ⅰ,II study using topical EGCG in cancer~     patients receiving radiotherapy or concurrent chemoradiotherapy .~   "
159238|NCT01481805|"~     To explore biomarkers predictive of clinical response to sorafenib in unresectable~     hepatocellular carcinoma using the Prometheus Platform To analyze expression and activation~     status of receptor tyrosine kinases in signal transduction pathways in FNA samples and~     circulating tumor cells.~      To identify negative predictive markers to sorafenib. To elucidate signal transduction~     pathway attributable to sorafenib resistance. To monitor changes in the RTK activation status~     during sorafenib treatment using circulating tumor cells.~      To analyze correlation between the quantity of circulating tumor cells and circulating~     endothelial cell precursors and treatment response to sorafenib.~   "
159239|NCT01481792|"~     Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for~     lamellar resection (ReLEx smile) in the reduction of myopia.~   "
159240|NCT01481779|"~     The purpose of this study is:~        -  To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of~          treatment.~        -  To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin~          glargine during 78 weeks of treatment.~        -  To compare the number of participants on LY2605541 reaching blood sugar targets without~          low blood sugar episodes at night to those taking insulin glargine after 78 weeks of~          treatment.~        -  To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during~          78 weeks of treatment.~   "
160144|NCT01469923|"~     This is a randomised and single-blind, placebo-controlled study to investigate the safety,~     tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of AZD2820~     to obese but otherwise healthy male subjects.~   "
159241|NCT01481766|"~     The pre-school years are critical years for children to acquire early learning skills such as~     language, fine motor and social skills; this is termed early child development. Primary care~     doctors (family doctors and pediatricians) are in a unique position to identify children with~     health or developmental problems. Screening is the process of testing healthy people for the~     earliest signs of health problems, followed by treatment, with the expectation that screening~     will improve the health of those screened. The focus of this research is screening young~     children for the earliest signs of iron deficiency (low blood iron levels) followed by~     treatment with oral iron.~      Previous research has shown that children with later stages of iron deficiency have serious~     delays in their development. Some research has shown that these delays may persist into young~     adulthood often with a significant reduction in intelligence. Early stages of iron deficiency~     may be difficult for parents or doctors to detect, and a blood test is usually needed.~     However, Canadian guidelines do not recommend screening all children for iron deficiency,~     because there is not enough good quality research to prove that screening is effective.~      In this study, the investigators will ask parents to allow their child between the ages of 1~     to 3 years to have a blood test for iron levels. If the blood level is low, the child will be~     randomly assigned to receive either oral iron liquid for 4 months plus diet counseling, or a~     placebo liquid plus diet counseling. A psychologist will measure each child's early learning~     ability before and after the treatment. If this approach to screening children's blood iron~     levels followed by treatment improves children's development, parents and doctors may~     consider that routine blood screening tests are justified. Overall, this research is an~     important step to improving the ways in which primary care doctors can ensure that children~     have the best start to life-long health and achievement.~   "
159242|NCT01481753|"~     The investigators plan to perform a prospective randomized, head-to-head trial to test the~     hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy~     (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or~     Delayed Gastric Emptying (DGE).~   "
159243|NCT01481740|"~     Previous research regarding the use of phenylephrine has excluded obese subjects (BMI >35).~     This subgroup of patients represents a large portion of the obstetric patient population~     locally and nationally. It is unclear whether previous research should be extrapolated to the~     obese patient population. This study is being done to compare the incidence of hypotension,~     intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive~     a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the~     treatment of established hypotension. This study will help us determine whether using a~     phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal~     induced hypotension during cesarean deliveries in obese patients.~   "
159244|NCT01481727|"~     The purpose of this study is to evaluate the efficacy of high-intensity non invasive~     mechanical ventilation (during one year to reduce the severity and frequency of acute~     exacerbation of chronic obstructive pulmonary disease (AECOPD) in patients with frequent~     AECOPD (frequent exacerbations defined more two or more AECOPD) and in GOLD IV stage (very~     severe COPD). The design is a randomised, double blind and controled with placebo (sham~     maneuver) clinical trial.~   "
159245|NCT01481714|"~     An excellent bowel cleansing is mandatory to increase the diagnostic accuracy of colonoscopy.~     Failure to adequately cleanse the bowel for colonoscopy can lead to missed lesions, prolonged~     procedure duration and repeated procedures at earlier intervals. Emerging solid evidence is~     pointing out the need of switching from preparation the day before to regimens in which half~     or even more of the preparation is administered the same day of the procedure, which have~     extensively demonstrated to provide a significantly better cleansing, being well tolerated.~     Preparation can be fully administered the same day for afternoon procedures, whereas~     split-dose regimens fit better with morning colonoscopies. However, the ideal regimen for~     early morning colonoscopies is still to be elucidated. The second part of the preparation for~     these patients is usually recommended to be taken during sleeping time (2-3 am) on the belief~     that intake of fluids should be completely halted at least four hours prior to the~     colonoscopy procedure Sodium picosulphate is a unique orange-flavoured cleansing agent dosed~     as two powder sachets. Mayor advantages in comparison with current alternatives are~     relatively small volumes (each sachet is mixed with only 150-250 mL of water) and a more~     pleasant taste. It provides similar bowel cleansing than sodium phosphate and polyethylene~     glycol solutions administered the day before. Nonetheless, focus on split-dose regimens has~     been set on several polyethylene glycol (either high-volume or low-volume) regimens, but no~     data are available for split-dose sodium-picosulphate regarding colonoscopy in adults.~      The aim of the study is to evaluate the efficacy and safety of a sodium-picosulphate~     low-volume split-dose regimen, in which the second-half of the preparation and fluids intake~     are allowed until 2 hours for early morning colonoscopies and until 2-6 hours for morning~     colonoscopies, comparing this split-dose regimen with standard cleansing the day before with~     sodium picosulphate/magnesium citrate.~   "
159246|NCT01481701|"~     This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant~     tumors Folfox regimen.~   "
159247|NCT01481688|"~     The purpose of this study is to investigate whether intradialytic exercise increases removal~     of waste products from blood, in comparison to the traditional prescription of increasing~     dialysis duration.~   "
159248|NCT01481675|"~     To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb~     (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.~   "
159249|NCT01481662|"~     SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss,~     and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of~     patients with SS, mostly young women, have been reported. However, comprehensive~     epidemiological, clinical and etiological features of SS have never been specifically~     addressed so far.~      The objective of this study is to characterize the epidemiological, clinical, and etiological~     features of SUSAC's Syndrome. In this aim, the investigators will constitute a national~     clinical-based cohort including all SS cases retrospectively reported in France since the~     last 20 years and all new cases prospectively observed. French Society of Neurology,~     Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed~     by an expert comity of internists, neurologists and neuroradiologists to validate the~     diagnosis. The exhaustive and systematic analysis of each case will help to better define~     different aspects of the disease such as the incidence and prevalence, the clinical~     presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor~     magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral~     microvasculopathy of the disease. Serum, cerebrospinal fluid, and DNA samples from each~     patient will also be collected to study potential autoimmune, thrombotic and infectious~     markers.~   "
159250|NCT01481649|"~     The purpose of this study is to determine whether preemptive nucleoside analogue therapy or~     regular virologic monitoring is the preferred method in management patients with prior~     exposure to hepatitis B vius (HBV) and undergoing hematopoietic stem cell transplantation~     (HSCT).~   "
159251|NCT01481636|"~     The purpose of this study is to investigate the correlation between health outcomes~     associated with the severity of obstructive sleep apnea (OSA) symptomatology, the findings~     will guide the design of interventional studies.~   "
159497|NCT01478412|"~     This trial is to determine if prostate target delineation obtained through an ultrasound~     based system is equivalent in accuracy to the MRI image fusion, and if alignment correction~     vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray~     imaging for daily prostate positioning.~   "
159252|NCT01481623|"~     Type 1 Diabetes is a multifactorial disease, with a strong genetic contribution of HLA genes,~     and minor contributions of many additional genes. The investigators hypothesis is that in~     addition to multifactorial inheritance, there are subtypes of diabetes that are caused by~     defects in single genes (monogenic diabetes). The aim of this project is to identify these~     genes, based on detailed clinical and characterization of patients, and to describe the~     corresponding genetic diabetes entities with respect to the genetic and molecular defect,~     clinical features and biochemistry. Based on the investigators study design, most of these~     diabetes entities will be caused by mutations affecting the two copies of the corresponding~     gene. In addition, the investigators will study the relatives of the patients, and explore if~     carriers of these genetic defects (i.e. only one copy of the gene being defective) may have a~     predisposition to common forms of diabetes, mainly type 2 diabetes.~   "
159253|NCT01481610|"~     The purpose of this study is to determine whether the use of lumiracoxib in this particular~     population is associated with a decrease in glomerular filtration rate (GFR) compared to~     diclofenac; and to compare the magnitude of such impairment, if any, associated with use of~     lumiracoxib and diclofenac.~   "
159254|NCT01481597|"~     Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic~     antitumor activity. The purpose of the present study is to investigate the safety and~     pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following~     single-dose administration.~   "
159255|NCT01481584|"~     The objective of the study is to evaluate the nutritional and physiological properties of two~     canola proteins focusing on the bioavailability in humans.~   "
159256|NCT01481571|"~     The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte~     vitrification/warming media and the vitrification device Rapid-i™, when using vitrification~     as a cryopreservation method for human oocytes.~   "
159257|NCT01481558|"~     This is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects~     of repeated transcranial direct current stimulation for the treatment of apathy in moderate~     Alzheimer's Disease in patients selected from an outpatient clinics in São Paulo, Brazil.~   "
159258|NCT01481545|"~     The purpose of this study is to evaluate the use of chemotherapy, radiation therapy and~     bevacizumab before surgery in patients with locally advanced rectal cancer (LARC).~   "
159259|NCT01481532|"~     The primary objective of the study is to assess whether human subjects can be made tolerant~     to intravenously administered Crotoxin and achieve higher and more therapeutically effective~     doses levels without the previously reported adverse effects associated with bolus i.m.~     administration.~   "
159260|NCT01481519|"~     Viral conjunctivitis causes redness, tearing, swelling, and irritation of the eyes that~     typically lasts from 1 to 3 weeks. Current management of this condition focuses on supportive~     care while the viral infection completes its course and resolves. However, many patients~     still experience substantial discomfort despite standard treatments, and, given the~     disproportionate morbidity and potential economic impact associated with an outbreak of~     infective conjunctivitis, a therapeutic agent that reduces clinical symptoms of and minimizes~     shedding of infectious virus would be desirable.~      Povidone-iodine is an antiseptic extensively used in preparation for general surgery,~     ophthalmic purposes, and laboratory disinfection. Dilute povidone-iodine solutions inhibit~     numerous viruses, bacteria, fungi, and some other parasites. Low cost, effectiveness, and~     lack of microbial resistance make povidone-iodine an appealing drug to treat ocular~     infections, especially in developing countries. Previously studies showed that~     povidone-iodine is a potential option to reduce contagiousness in cases of adenoviral~     infections. Dexamethasone 0.1%/povidone-iodine 0.4% it is a mixture containing a steroid and~     antiseptic is promising as a suitable therapeutic agent for the treatment of EKC. A small,~     prospective, open-label, single-armed clinical trial of dexamethasone 0.1%/povidone-iodine~     0.4% administration in humans with symptoms of acute conjunctivitis who tested positive for~     adenoviral antigen was therapeutically successful. In other study, dexamethasone~     0.1%/povidone-iodine 0.4% combination markedly lowered the viral concentration and improved~     the manifestations of the disease.~      So, the favorable human data in combination with in vivo results provide a strong impetus for~     a human phase III clinical trial to test the efficacy of this drug in a larger group and also~     to evaluate complete safety to properly establish the therapeutic benefit versus adverse~     effect for these reasons, the investigators chose to study the efficacy of dexamethasone~     0.1%/povidone-iodine 0.4% in treating the symptoms and signs of viral conjunctivitis. The~     administration of dexamethasone 0.1%/povidone-iodine 0.4% can be a secure, tolerable and~     affective treatment to inflammatory and infective component of acute viral conjunctivitis.~   "
159261|NCT01481506|"~     Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and~     disease-related need of care. Selected interventions were able to reduce the number and the~     severity of exacerbations. Telemedicine has also been proposed for this purpose. Current~     evidences, however, are scant. The investigators present a randomized, parallel-group trial~     of a multiparametric remote monitoring system to test its ability to improve early~     exacerbation detection rates and impact on clinical outcomes.~   "
159262|NCT01481493|"~     The study is conducted in order to find out if repeated doses of the monoclonal (artificially~     manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently~     respond to a treatment with methotrexate (MTX).~   "
159263|NCT01481480|"~     A massive tear of the rotator cuff is a debilitating condition that causes pain, significant~     impairments in strength, and resultant loss of activity of the affected arm. To our~     knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive~     rotator cuff tears. Adding the first randomized controlled trial to will be a substantial~     contribution to the current body of evidence available in the subject of massive rotator cuff~     tears. Most studies found in the literature following patients with massive rotator cuff~     tears are retrospective, have small numbers of patients, offer no control group and do not~     adequately compare treatment methods.Moreover, there is no consensus from experts regarding~     which treatment is superior.~      Our multicentre orthopaedic study group proposes a multicentre randomized clinical trial~     prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the~     treatment of massive rotator cuff tears. This study will include the use of comprehensive~     functional, motor and radiographic outcome assessments.~   "
159304|NCT01480947|"~     Diarrhea due to acute enteritis is a common symptom in the children. Lots of patients are~     infected by rotavirus or salmonella.~      Base on the past researches, there is benefit effect of probiotics on patients with diarrhea~     or acute enteritis. In this clinical study, bio-Three, a probiotic which contains three~     independent probiotics, will be used in patients with acute diarrhea.~      This is a single site, controlled clinical research. About 80 patients will be enrolled into~     this study to evaluate the benefit effect of bio-Three among patients with acute enteritis~     due to rotavirus or salmonella or other unknown reason. Patients will be diagnosed and~     screened by inclusion and exclusion criteria and only eligible patients will be enrolled into~     this study.~   "
159264|NCT01481467|"~     Influenza is a serious disease which can cause severe illness and even death among patients.~     Health care workers (HCWs) often get infected with influenza and up to 76% of them keep~     working while being ill. Immunizing HCWs is therefore an essential factor in protecting~     patients from influenza as HCWs easily transmit influenza to their patients.~      However, despite recommendations from the Dutch Health Council since 2007, vaccine uptake~     among HCWs remains low.~      The aim of this study is to develop an effective implementation strategy on the basis of~     previous behavioural studies and to evaluate its value in a clustered randomized trial in all~     Dutch University Medical Centers (UMCs). Also, we want to assess the program elements that~     are associated with a higher vaccine uptake and the cost-effectiveness of such an~     implementation strategy.~      The results of this study will give more insights in the way influenza vaccination campaigns~     should be directed in order to achieve high vaccine uptake rates among HCWs in hospitals.~   "
159265|NCT01481454|"~     The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine~     (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune~     response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).~      Primary Objective:~        -  To describe the safety profile (injection site reactions and systemic events) of each~          vaccine during the 21 days following vaccination, and serious adverse events (including~          adverse events of special interest) throughout the study in all adult and~          child/adolescent participants.~      Secondary Objectives:~        -  To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine~          (QIV) induce an equivalent immune response at 21 days post-vaccination in both age~          groups (lot consistency)~        -  To describe the compliance of the immunogenicity of QIV to the European Medicines Agency~          Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.~   "
159266|NCT01481441|"~     With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised~     with the potential to improve ultrasound imaging for prostate cancer detection and~     localisation significantly. The past years numerous studies have been performed with CEUS,~     all basing their results on subjective judgement of the investigator. CEUS image~     interpretation is difficult and requires a well-trained expert. To overcome these~     difficulties CEUS quantification techniques can be of use. The techniques used in this~     protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e)~     and BRACCO, Geneva.~      The investigators hypothesize improvement of the PCa detection rate with quantification,~     compared with subjective CEUS interpretation and known numbers in literature.~      Also a comparison between quantification results and tumour differentiation grade (Gleason~     score) will be made, the investigators hypothesize a positive correlation.~   "
159267|NCT01481428|"~     This study will be the first to examine the efficacy of using a brief, computerized HIV risk~     reduction intervention in treatment courts.~   "
159268|NCT01481415|"~     The investigators study is trying to find the normal value to left atrial volume and left~     atrial function in healthy children by tridimensional real time echocardiography avaluation.~   "
159269|NCT01481402|"~     Purpose: The purpose of the study is to examine if treatment with liothyronine increases left~     ventricular ejection fraction (LVEF) in patients with stable, chronic heart failure.~   "
159270|NCT01481389|"~     The purpose of this study is to determine the effect of theobromine on blood lipid parameters~     in healthy subjects. Secondary objectives are to determine the effect of cocoa and an~     interaction effect of cocoa and theobromine on blood lipid parameters.~      Hypothesis: theobromine has a positive effect on blood lipid parameters.~   "
159271|NCT01481376|"~     The objective of this retrospective study is to evaluate the postoperative clinical outcomes~     at discharge, 1 month and 12 months, associated with the use of Parietex™ ProGrip™ in~     Laparoscopic Transabdominal preperitoneal inguinal hernia repair. Results from this study~     will be used to support the short- and long-term clinical outcomes of Parietex™ ProGrip™ when~     used in inguinal hernia repair by laparoscopic approach.~        -  Single center study~        -  Population: All subjects have undergone Laparoscopic Transabdominal preperitoneal~          surgical treatment for inguinal hernia repair with Parietex™ ProGrip™ without additional~          fixation between September 2008 and March 2010 (inclusive) with at least 12 months of~          follow-up.~      The primary outcome:~      • Proportion of subjects who experience hernia recurrence (defect treated initially with~     Parietex™ ProGrip™) within 12 months post-surgery.~      Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a~     Valsalva maneuver in the operated groin.~      The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the~     recurrence diagnosis is confirmed during a physical examination by a physician and defined as~     a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the~     operated groin. If subject has a surgical repair of the hernia within the 12 month~     postoperative period, it will be documented as evidence of hernia recurrence.~      The secondary outcome:~        -  Incidence of Groin Pain (pain score 0-10) and analgesic use at discharge, 1 month and 12~          month postoperatively~        -  Incidence of postoperative complications including, wound infection (any infection of~          the incision), mesh infection (an infection of the mesh), bleeding, mesh migration, mesh~          erosion, fistula, small bowel obstruction, seroma, hematuria, hematoma, inflammation,~          chronic pains/ inguinodynia, infection, visceral adherence, allergic reactions to the~          components of the product at discharge, 1month and 12 month post-operatively~        -  Patient satisfaction~        -  Operative time~        -  Hospital length of stay~   "
159272|NCT01481363|"~     Do family carers of people with dementia benefit from communication therapy and training?~     This study will only involve carers of people with dementia. Nearly all people with dementia~     will experience some difficulty communicating. Family carers of people with dementia have~     described communication and associated behaviour difficulties as one of the hardest to cope~     with.~      This is a PhD study. The student/investigator has previously produced a detailed manual of~     approaches for supporting relatives of people with dementia who are experiencing~     communication difficulties. Previously published communication guides by other authors do not~     present research evidence.~      Carers will be recruited to this study from the local NHS older person's mental health~     service overseen by their relative's psychiatrist. Only family carers will be included.~     Recruits will be randomly assigned to a treatment group or a control group. People in the~     control group will receive treatment as usual. The carers will be seen at home or at an NHS~     site if they prefer. The investigator and carer will work through the contents of the manual~     together. The manual is designed to consider their knowledge, thinking, skills and behaviour.~     The treatment will take no more than 4.5 hours over a period of up to 12 weeks.~      Carers will be asked to complete questionnaires before and after the treatment. As well as~     background information, these questionnaires will look for any significant effects of the~     treatment on carers' anxiety and depression, carers' quality of life, carers' belief in their~     ability to care, communication difficulties experienced and the carers perceptions of their~     relatives communication competence.~      A sample of 15 carers will also be interviewed by a third party interviewer who will be an~     existing speech and language therapy employee of Solent NHS Trust (see attached job~     description and person specification). The interviews will ask more specifically about their~     thoughts, feelings and opinions of this intervention and their experience in addressing~     communication difficulties.~   "
159273|NCT01481350|"~     Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac~     surgery for valvular heart diseases, especially in patients with a long life mitral valve~     disease. The present study wants to test the hypothesis that intravenous administration of~     sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.~   "
159305|NCT01480934|"~     To compare the development of posterior capsule opacification (PCO) between eyes with and~     without a history of diabetes mellitus (DM) after single-piece hydrophobic acrylic~     intraocular lens (IOL) implantation 4 years postoperatively.Diabetes mellitus would not~     increase the incidence of PCO at 4 years.~   "
159274|NCT01481337|"~     The endoscopic management of patients on anti platelet agents is a wide problem more and more~     common, with prevalence of patients on this type of therapy steadily increasing. The risk of~     bleeding on antiplatelet during an endoscopic examination can be major. The risk of~     cardiovascular thrombotic accident in dirty shutdown of anti platelet, was recently described~     as significant (4-5%). Current recommendations for polypectomy allow the gesture as aspirin~     and are based on literature data scarce, often retrospective. Such work may be for a lack of~     increased bleeding risk during a colonic polypectomy under aspirin. There is to date no~     significant data published on the implementation of the endoscopic mucosal resection~     (mucosectomy) under aspirin. It is necessary to achieve a national multicenter observational~     study on a large scale in the daily practice of colonic polypectomy / mucosectomy in patient~     taking aspirin.~      The aim of the study is to determine the incidence of immediate and delayed bleeding colonic~     polypectomy and mucosectomy with aspirin. The patients undergoing colonoscopy and taking a~     long-term aspirin therapy and presenting a major risk of thromboembolism or medium will~     incluables. Inclusion will be achieved for those patients receiving aspirin colonoscopy after~     signing a specific consent. Polypectomy will be possible according to the recommendations of~     the French Society of Digestive Endoscopy. Upon discovery of a lesion to be resected by~     mucosectomy, the patient will benefit from the mucosectomy. The study is observational,~     multicenter, prospective, national. The polypectomies / colonic mucosectomies will be made~     using the conventional techniques and the current recommendations. The immediate and delayed~     hemorrhage meet specific definitional criteria. The number of patients to be included will be~     1000. The duration of the study inclusions will be 36 months. The trial will be conducted in~     full compliance with laws, regulations and ethical aspects.~      It is expected in this work that the incidence of post-polypectomy bleeding under aspirin is~     the same. The rate of bleeding reported in the post mucosectomy size is higher compared to~     the polypectomy: it is however expected that the rate of bleeding in the post mucosectomy~     with or without aspirin is indifferent. It will follow a recommendation of French society~     adapted to endoscopy for this type of procedure~   "
159275|NCT01481324|"~     It has been shown that compliance with brace wear can significantly improve the treatment~     outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be~     around 30-41% with initial orthosis wear after successful treatment with serial castings.~     These studies have depended on family logs and not objective data. With the development of a~     monitoring device, this study hopes to examine: (1) actual patient compliance, (2)~     comparisons of actual wear time and assumed wear time and (3) the relationship of patient~     wear with clinical outcomes.~      Hypothesis:~      Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported~     compliance and noncompliance is correlated to future surgeries.~   "
159276|NCT01481311|"~     The aim of this clinical investigation is to prove that the seca mbca detects dialysis~     patients with abnormal water distribution correctly. Abnormal high water distribution is~     defined as more than 2 liters of Total Body Water (TBW) above a normal value range. TBW and~     Extra Cellular Water (ECW) are calculated with prediction equations for healthy subjects~     generated in BCA-01. The results are compared with TBW and ECW ascertained by dilution~     methods as standard reference methods. The Bioelectrical Impedance Analysis (BIA) method~     should be evaluated to the accuracy of the absolute measurement of the volume state of~     dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.~   "
159277|NCT01481298|"~     Left ventricular non-compaction (LVNC) is a rare cardiomyopathy characterized by numerous~     excessively prominent left ventricular (LV) trabeculation and deep intertrabecular recesses~     communicating with the ventricular cavity and severely altering myocardial structure.~     Although most authors assume a developmental arrest in embryogenesis as the underlying~     pathology, the mechanisms of LVNC are not fully understood yet. Several gene mutations have~     been identified to be linked with LVNC and an autosomal dominant inheritance pattern is~     frequent To date the most commonly used imaging tool for diagnosing LVNC is echocardiography~     applying the criteria established by Jenni and coauthors However, qualitative parameters to~     differentiate normal compaction of the myocardium in healthy subjects from LVNC or from other~     cardiomyopathies like dilative cardiomyopathy (DCM) or hypertrophic cardiomyopathy (HCM) may~     fail due to highly variable LV trabeculation. Therefore, absolute quantification should be~     performed. Cardiac magnetic resonance (CMR) has been reported as a promising imaging modality~     to characterize patients with LVNC as it provides both a high spatial resolution and a good~     contrast between trabeculation and blood pool Jacquier et al. recently described a value of~     trabeculated LV myocardial mass above 20% of the global mass of the LV to be highly sensitive~     and specific for LVNC However, in their approach, a substantial degree of the LV cavity was~     included into calculated trabecular LV mass and led to systemic overestimation of the latter.~     Furthermore, the role and prognostic value of myocardial scarring as assessed by delayed~     enhancement (DE) CMR was not evaluated.~      The aim of the retrospective study was to establish revised and extended CMR criteria to~     distinguish LVNC from DCM, HCM and a group of healthy controls and to improve the assessment~     of trabeculated mass by excluding intertrabecular blood pool.~   "
159278|NCT01481285|"~     The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI~     and FFMI is based on the results of two other clinical investigations: Generation of~     prediction equation to analyze body composition of adults based on Bioelectrical Impedance~     Analysis (BIA) (BCA-01) and Application and adaption of device specific body composition~     formulas to various ethnic groups (BCA-02). The aim of BCA-01 was to develop prediction~     equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods~     ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the~     other hand. The equations are necessary to use the device as a Body Composition Analyzer with~     an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to apply~     and adapt device specific body composition formulas to various ethnic groups.~   "
159279|NCT01481272|"~     It is expected that addition of anti-CD20 antibody - ofatumumab would enhance the activity of~     the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim (IVAC)~     regimen. This study is planned to determine the efficacy and safety of ofatumumab in~     combination with IVAC chemotherapy in patients with CD20 positive diffuse large B cell~     lymphoma progressing or relapsed after prior R-CHOP chemotherapy not suitable for Autologous~     Stem Cell Transplant (ASCT).~   "
159280|NCT01481259|"~     Maintenance therapy has been considered as an important component to prolong survival in~     patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have~     confirmed that pemetrexed is one of the effective drugs in improving progression-free~     survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic~     deliveries of pemetrexed, however,the functioning status and immune system may get worse,~     which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with~     autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism~     through stimulating immune response and altering the interaction between tumor and its host.~     This effect may result in improved tumor control and survival, as well as a better quality of~     life. To test the hypothesis, a randomised controlled study was conducted to compare CIK~     cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell~     lung cancer.~   "
159306|NCT01480921|"~     The objective of this study is to compare the effect of monitored, home-based exercise versus~     hospital-based exercise on the quality of life of patients with congestive heart failure.~     Secondary objectives are to assess the effect of the intervention on exercise capacity and~     caregiver burden.~      The investigators hypothesize that the exercise training in the home-based environment will~     be superior to hospital based exercise training.~   "
160145|NCT01469910|"~     The purpose of this study is to assess the safety and pharmacokinetics of single ascending~     doses of Simotinib Hydrochloride in healthy subjects.~   "
159283|NCT01481220|"~     Patients with Myelodysplastic Syndromes (MDS) often suffer from low platelet levels which may~     lead to bleeding complications. Treatment with cytotoxic agents can decrease the platelet~     levels further. Eltrombopag is a relatively new drug that increases the platelet level in the~     blood by working directly on the bone marrow. It is available for treatment of the disease~     Immunological Thrombocytopenic Purpura (ITP). In this study patients with MDS and low~     platelet levels that are treated with the cytotoxic agent Azacitidine will also receive~     Eltrombopag. The administration of Eltrombopag to MDS patients treated with Azacitidine may~     result in less dose reductions and less treatment delays for Azacitidine and may reduce the~     need for thrombocyte transfusions and lower the risk of bleeding complications.~      This is a phase I study, meaning that our major goal is to investigate the safety and~     tolerability for Eltrombopag in this patient group. It will also generate a basis for a phase~     II-III-study.~   "
159284|NCT01481207|"~     Neonatal hypoxic ischemic encephalopathy (HIE) is a serious neurological condition~     characterised by acute or subacute brain injury arising from perinatal hypoxia. HIE is~     thought to affect approximately 0.2% of live births, and is associated with a high risk of~     mortality or long-term neurological disability.~      Accurate biomarkers for long-term neuro-developmental outcome following HIE are extremely~     important both for clinical management and the evaluation of therapeutic approaches.~     According to a recent meta-analysis, the ratio of the cerebral concentrations of lactate and~     N-acetyl aspartate (NAA), two neuro-metabolites detectable with magnetic resonance~     spectroscopy (MRS), currently represents the most accurate prognostic indicator of outcome~     following HIE. However, for various technical reasons standard MRS methods do not offer~     optimal sensitivity for detecting lactate, which may potentially be improved with a custom~     lactate editing MRS sequence. In addition, while perfusion has also been suggested as a~     potential biomarker for neuro-developmental outcome following HIE, due to a paucity of MR~     perfusion imaging studies in neonates, the prognostic accuracy of perfusion MR measures has~     not been evaluated in comparison with more established MR biomarkers. The aims of this study~     are:~        1. to evaluate the relative sensitivity of a custom lactate editing MRS pulse sequence~          (specialist software) relative to the standard point resolved (PRESS) MRS sequence for~          detecting lactate in neonates with suspected HIE.~        2. to evaluate the sensitivity and specificity of MR perfusion measures in comparison to~          MRS measures as predictors of neuro-developmental outcome at 2 years.~   "
159285|NCT01481194|"~     The purpose of this study is to evaluate the efficacy and safety of the combination treatment~     of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide in newly~     diagnosed multiple myeloma patients.~   "
159286|NCT01481181|"~     In low-income settings in developing countries unsafe water is one of the leading causes of~     high prevalence of waterborne diseases such as diarrhoea.Zinc is an essential trace element~     that has a critical role in growth and immunity. Supplementation with zinc is considered~     effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard~     Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called~     LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological~     contamination and enriches water with zinc at a concentration of 3.5 mg/L. The objective of~     the study is to assess the efficacy of LSF to increase the zinc status (serum zinc~     concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.The study~     hypotheses are:~      A. Use of the LSF device will reduce microbiological contamination of the household supply of~     drinking and cooking water; B. Use of the LSF device will increase zinc intakes in preschool~     children; C. Use of the LSF device will increase serum zinc concentration in preschool~     children; D. Achieving A, B and C will improve growth in preschool children; E. Achieving A,~     B and C will reduce the frequency and duration of diarrheal disease in preschool children and~     in members of the participating households.~   "
159287|NCT01481168|"~     The purpose of this study is to determine whether or not the intravenous adenosine test~     readily identifies patients with unexplained syncope who would benefit from permanent~     pacemaker implantation.~   "
159288|NCT01481155|"~     The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy~     is superior in the treatment of actinic keratoses with respect to efficacy and side effects.~   "
159289|NCT01481142|"~     The objectives of the study are to observe and document the efficacy and safety of 5 or more~     Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of~     ulcerative colitis patients. The patient subset of interest is those with moderate/severe,~     steroid-dependent, active ulcerative colitis with insufficient response or intolerance to~     immunosuppressants and/or biological agents.~   "
159290|NCT01481129|"~     This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with~     relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
159291|NCT01481116|"~     The purpose of this study is to determine the efficacy and safety of TAK-875, once daily~     (QD), plus metformin compared to glimepiride plus metformin in participants with type 2~     diabetes mellitus (T2DM).~      The purpose of this study is to determine the efficacy and safety of TAK-875, once daily~     (QD), plus metformin compared to glimepiride plus metformin in participants with type 2~     diabetes mellitus (T2DM).~   "
159292|NCT01481103|"~     This research is being done to study the effect of incorporating acupuncture into the~     management of migraines. The primary aim is to determine in a randomized, controlled study~     whether individuals experiencing migraines have fewer occurrences and less intense migraines~     when acupuncture is integrated with nonprescription pharmacological treatment.~     Nonprescription pharmacological treatment in this study refers to the use of the following~     over the counter medications: Aspirin, Ibuprofen, Naproxen, Acetaminophen (with or without~     caffeine). Aspirin, Ibuprofen, and Naproxen are members of a class of drugs known as~     non-steroidal anti-inflammatory drugs or NSAIDs.~   "
159363|NCT01480167|"~     The objective of this post market clinical investigation is to evaluate the clinical~     effectiveness of a minimally invasive vertebral augmentation procedure,~     Radiofrequency-Targeted Vertebral Augmentation (RF-TVA) as compared to non-operative~     management (NOM) for the treatment of appropriately diagnosed acute (≤ 8 weeks) painful~     osteoporotic vertebral compression fractures (VCF).~   "
183259|NCT01166087|"~     The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride~     Delayed-Release Capsules, 90 mg and Prozac ® weekly under fed conditions.~   "
159293|NCT01481090|"~     One of the most widely used procedures in reproductive medicine technologies is In Vitro~     Fertilization (IVF). During the IVF procedure, there are sometimes unused embryos that are~     frozen to be used at later times. If these embryos are thawed and transferred back to the~     mother, proper development of the uterine lining plays an important role in outcome of~     pregnancy. Electro-acupuncture (EA), a technique where electrical current is applied to the~     needle to stimulate an acupoint, has been shown to increase uterine blood flow, increasing~     the likelihood of developing a more ideal endometrial lining. This randomized study aims to~     evaluate the impact of EA on endometrium undergoing medicated frozen embryo transfer cycle~     preparation. The treatment group will receive four acupuncture treatments during the~     medicated uterine preparation. Endometrial thickness will be compared to a group that does~     not receive acupuncture.~   "
159294|NCT01481077|"~     The purpose of this study is to determine the effect of plug placement on the efficacy,~     safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).~   "
159295|NCT01481064|"~     The purpose of this study is to evaluate the effects and costs of a multifaceted approach on~     the patient-centredness of fertility care and the quality of life of fertility patients.~   "
159296|NCT01481051|"~     The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS~     (latanoprost punctal plug delivery system) at different dose levels.~   "
159297|NCT01481038|"~     Up to date methods for diagnosis of Catheter Related Bloodstream Infections (CRBSI) are~     performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from~     CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis~     or septic embolism when diagnostic procedures for the detection of CRBSI are introduced. The~     aim of the project is to investigate a more sensitive and specific test for anticipative~     diagnosis of CRBSI using biphasic PNA FISH test compared to Gram stain/AOLC test.~   "
159298|NCT01481025|"~     Climacteric Complains bring to women many problems for living a normal life - hot flashes,~     irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new~     horizon for this part of time.~   "
159299|NCT01481012|"~     The purpose of this study is to obtain data or information on how blood clotting factors are~     activated during open heart surgery. In particular, the investigators are interested in how~     blood clotting factors are activated by the heart-lung bypass machine and by left ventricular~     assist devices (LVAD). Patients on these two machines have an increased risk of bleeding and~     blood clot formation. This is because both machines stimulate the intrinsic coagulation~     pathway, one of the chemical pathways that cause blood to clot. The process of surgery itself~     also stimulates the extrinsic coagulation pathway, the other chemical pathway that causes~     blood to clot. Stimulating these coagulation pathways can use up the body's clotting factors.~     As a result, patients may be at risk for both bleeding and blood clot formation. The~     investigators would like to study how the blood factors are activated during and after~     surgery, to help develop treatments to prevent bleeding and clot formation.~   "
159300|NCT01480999|"~     The use of robotic surgery in the management of gynecologic cancers has increased~     exponentially in the United States since the implementation of technology in 2005. In Canada,~     access to the system is limited because of a lack of government funding. The government has~     been reluctant to fund this technology because robust data, on the true impact to patient~     care, is lacking.~      This project will prospectively examine outcomes of women, with early stage endometrial~     cancer, treated surgically. Open surgery will be compared to minimally invasive surgery (MIS)~     which will include conventional laparoscopy and robotic surgery. The data collected will~     include detailed assessment of surgical data, peri-operative events, quality of life~     analysis, health economic evaluation and evaluation of MIS rates.~   "
159301|NCT01480986|"~     This is a prospective, single-armed, open label study on the efficacy and safety of~     sequential IP therapy(Irinotecan plus cisplatin) and octreotide lar in the treatment of GI~     poorly diffrentiated Neuroendocrine carcinoma. Patient with written consents will enter the~     phase one step of the trial, receiving IP therpy. Once the IP therapy has been finished~     without disease progression or progression occurs during the treatment, the patient will~     enter the phase two step of the trial, receiving octreotide treatment. The primary endpoint~     is progression free survival in the two steps respectively and secondary endpoint is disease~     control rate, overall survival and safety~   "
159302|NCT01480973|"~     NSCLC is the leading cause of cancer mortality in North America, accounting for nearly 30% of~     all cancer deaths. The standard treatment for patients with early-stage non-small-cell lung~     cancer (NSCLC) is surgical resection of the involved lobe/lung. However, many patients are~     unable to undergo such a major surgery due to medical illness, and an emerging~     standard-of-care for these patients stereotactic-body radiation therapy (SBRT).~      SBRT involves highly precise delivery of very high dose Radiotherapy (RT) over a very few~     fractions (hypofractionation) to accurately describe, size-restricted malignant targets in~     which motion has been accounted for during the delivery process. SBRT administration achieves~     avoidance of normal tissue exposure to radiation during the planning process, by providing~     for sharp fall-off dose gradients outside the target.~   "
159303|NCT01480960|"~     Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in~     patients following lung transplantation. Exercise training has been shown to be a cornerstone~     of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise~     performance. In our study we will investigate the benefit of a whole body vibration training~     in addition to a standard pulmonary rehabilitation program that includes endurance and~     strength training. We will include a total of 140 patients (70 patients < 1 year after lung~     Transplantation and 70 patients > 1 year after lung Transplantation). Our hypothesis is that~     an addtitional whole body vibration training produces a greater benefit to exercise capacity~     in lung transplantat patients (LTx).~   "
159364|NCT01480154|"~     This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206~     together with hydroxychloroquine in treating patients with advanced solid tumors, melanoma,~     prostate or kidney cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     Akt inhibitor MK2206 together with hydroxychloroquine may kill more tumor cells.~   "
159307|NCT01480908|"~     The most common congenital heart disease is the ventricular septal defect, and after surgical~     closure of a such defect, an arrythmia called the right bundle branch block, is very~     frequent. Therefore the aim of this study is to investigate if this group of patients has~     inferior outcomes compared to the group without this arrythmia after surgical closure and~     compared to a group of healthy control subjects.~      All patients will be undergoing 1. exercise testing, 2. echocardiography, 3. echocardiography~     during exercise, and 4. MRI. The perspective is the ability to point out a group of patients~     with a possible need of further intervention, and additionally to increase the awareness of~     protecting the electrical system of the heart during the operation.~   "
159308|NCT01480895|"~     Diabetes Mellitus (DM) is a chronic metabolic disorder with increasing incidence and long~     term complications. Its incidence differs in various ethnic populations.Gestational DM (GDM)~     is diagnosed when impaired glucose tolerance (IGT) is first detected during pregnancy. GDM~     incidence in Jewish and Bedouin women has been rising in recent years. It has been reported~     in many studies that women who had been diagnosed with GDM are more prone to GDM in their~     next pregnancies and to DM Type 2.~      Appropriate changes in everyday diet and physical exercise may reduce the chances for future~     GDM and type 2 DM.~      The investigators aim was to determine GDM frequency in the Negev area in Jewish and Bedouin~     populations and to construct a plan for follow up and reduce future problems by changing~     their life style.~   "
159309|NCT01480882|"~     A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine~     which is supposed to mimic the chest percussion performed by professional physiotherapist to~     mobilize sputum through the respiratory passage.~      The aim of this study is to compare the effectiveness and safety of this mechanical~     percussion device in the treatment of airway clearance with conventional chest physiotherapy~     carried out by qualified physiotherapists in patients suffering from bronchiectasis or~     Chronic obstructive Pulmonary disease (COPD).~   "
159310|NCT01480869|"~     The purpose of this study is to compare normalization of vitamin D serum level after 6 months~     of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional~     vitamin D supplementation.~   "
159311|NCT01480856|"~     Cobedding consists of associating twins in a common cocoon in order to maintain links~     developed in utero and reduce the stress of premature birth. The aim of this randomized,~     controlled prospective study is to compare efficacy (in term of newborn daily weight gain)~     and safety of cobedding versus single-bedding of preterm twins.~   "
159312|NCT01480843|"~     The purpose of this study is to find out if simplifying your diabetes treatment by decreasing~     number of insulin injections, with the help of a long acting insulin called glargine, can~     decrease the episodes of low blood glucose.~   "
159313|NCT01480830|"~     Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In~     Canada, up to 13% all colonoscopies do not examine the full colon and are therefore~     incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to~     twists and turns in the colon that make the colonoscopy difficult to perform and~     uncomfortable for the patient.~      This randomized study is being done to test a new colonoscopy system called the Scope Guide~     that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the~     patient's abdomen.~      We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of~     colonoscopy quality including rate of complete examination, patient comfort, polyp detection~     rate, insertion time, amount of sedation required, and need for abdominal compression.~   "
159314|NCT01480817|"~     The investigators are going to compare the therapeutic effect of sorafenib and transarterial~     chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein~     invasion.~   "
159315|NCT01480804|"~     The purpose of this research study is to identify barriers affecting self care in older~     patients with diabetes and to provide coping strategies for these barriers with help from a~     care manager (Geriatric Life Specialist) to improve clinical, economical, functional and~     psychosocial parameters.~   "
159316|NCT01480791|"~     This study will be performed only at the Jewish General Hospital. It will investigate the~     effect of treatment with aliskiren, an inhibitor of renin, a substance produced by the kidney~     that constricts arteries and raises blood pressure, on the blood vessels, specifically the~     arteries, of subjects who have diabetes and elevated blood pressure (hypertension).~      To investigate blood vessels, different techniques will be used. For large arteries, these~     will be studied by non invasive methods using detection of the pulse wave or using ultrasound~     over the skin of the neck, the wrist and the groin. To study small vessels, the investigators~     will perform a biopsy on the buttock, under local anesthesia, and obtain a small sample of~     tissue from under the skin, from which the vessels will be dissected. The investigators have~     performed many hundreds of these small biopsies over the past 20 years for similar studies~     without any complications. The biopsies are very well tolerated. From this research the~     investigators will thus be able to learn what the structure and function of these vessels is~     in these patients, in comparison to a normal healthy group.~      The hypertensive diabetic subjects will then be assigned by chance (randomized trial) to~     treatment with the renin inhibitor aliskiren or a comparator, the diuretic~     hydrochlorothiazide. Aliskiren is a relatively new drug used to treat hypertension that is~     very well tolerated and is now being evaluated in numerous trials in hypertensive diabetic~     individuals. The diuretic is a well-know agent used to treat high blood pressure now for many~     years, and which is very well tolerated. Physicians, nurses and scientists involved in the~     study will be unaware of who is receiving which drug, as will be the patients (this is the~     meaning of double-blind trial). However, if there is any problem, the secret code will be~     broken and the individual withdrawn from the study. Subjects will be treated for a year, and~     the study procedures (non invasive and the biopsy) repeated at 6 months and after one year of~     treatment. During the study, blood samples will be drawn and urine collected at certain~     intervals to ensure safety of the treatment.~      Once tissues are obtained they will be studied in the laboratory. The study of the vessels~     will allow treatment us to determine how the treatment with the renin inhibitor aliskiren~     affects the structure and function as well as cellular and molecular aspects of arteries of~     hypertensive diabetic persons. The investigators expect these studies to provide us knowledge~     on mechanisms and perhaps new targets for future therapies of cardiovascular disease and~     hypertension.~   "
159317|NCT01480778|"~     Assessment of the pharmacodynamic profile of the drug Ciclo 21 ®, marketed by União Química~     Farmacêutica Nacional S / A, compared to the drug Nordette ® Laboratory Wyeth Pharmaceutical~     Ltda. Through the modulation of hormonal response (inhibition of the pituitary) evidenced by~     measurement serum LH and FSH for 28 days, as well as by the absence of follicle formation~     demonstrated by transvaginal ultrasound examinations~   "
159318|NCT01480765|"~     The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery~   "
159319|NCT01480752|"~     To determine the effect of intraligamentary injection of Lornoxicam on the intensity of~     post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.~   "
159320|NCT01480739|"~     Study in healthy volunteer to see effect of AZD5069 and placebo on neutrophil number and~     function (phagocytosis and oxidative burst) in the circulation, following a burst of~     strenuous exercise and following subcutaneous injection of granulocyte-colony stimulating~     factor (G-CSF)~   "
159321|NCT01480726|"~     Vena saphena magna is still frequently used as graft material in coronary artery bypass~     grating(CABG, and vein grafts can harvest with either the conventional open technique (Ovh =~     open vein harvesting), or with less invasive endoscopic techniques (EVH = Endoscopic vein~     harvesting). The endoscopic techniques have been shown to reduce the incidence of~     postoperative wound complications while patients are more satisfied with the cosmetic result~     of the operation on the leg.~      Non-randomized studies have raised doubts about patency rates of the vein grafts following~     EVH compared to OVH, while other studies failed to detect any problems in relation to this.~     There are only very few data on long-term patency rates from randomized studies.~      The purpose of this study is to investigate clinical outcome and patency rates of the vein~     grafts following either EVH and OVH in 132 patients who underwent CABG for 4-7 years ago as~     part of a randomized study investigation wound complications. A cost-effectiveness analysis~     will also be performed.~      The hypothesis is: Patency rates following EVH are worse compared to OVH in CABG 4-7 years~     postoperatively.~   "
159322|NCT01480713|"~     This is a pilot, proof of concept, open-label clinical trial, to assess the extend of~     persistent viral reservoir and the level of immune activation in patients receiving~     suppressive treatment with protease inhibitors.~      40 Chronically HIV-1 infected subjects, receiving monotherapy with ritonavir-boosted~     lopinavir or darunavir for at least 12 months with plasma viremia below 50 copies HIV RNA per~     ml, and CD4 T-cell counts greater than 500 cells/mm3 will be included.~      The total duration of the study will be 48 weeks: 12 weeks for patients' inclusion, 24 weeks~     of follow-up once the last patient is included, and 12 weeks for data analysis.~   "
159323|NCT01480700|"~     This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin~     from lucerne protein concentrate and DHA from microalgae on the plasma levels of these~     compounds but also on the macular pigment optical density, whose elevation may be beneficial~     in the prevention of Age-related Macular Degeneration (AMD).~   "
159324|NCT01480687|"~     The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty~     acid supplementation on the vascular structure and function in hypertensive patients with~     hypertriglyceridemia.~   "
159325|NCT01480674|"~     This observational study will characterize retrospectively patients with HER2-positive~     metastatic or locally advanced breast cancer who had received treatment with Herceptin~     (trastuzumab) in 1st line and who were without progression for at least three years. Patients~     will be followed prospectively for one year.~   "
159326|NCT01480661|"~     In this study the possible changes in airway geometry and function induced by 6 month oral~     treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory~     imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients~     will be examined. The study population consists of 40 severe COPD patients, global initiative~     for chronic obstructive lung disease (GOLD) stages III until IV.~      Imaging parameters will be assessed and the correlation with lung function and health related~     quality of life will be checked before and after treatment.~   "
159327|NCT01480648|"~     This first-in-man trial forms the basis for potential clinical development of BI 144807 in~     the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics,~     and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male~     volunteers.~   "
159328|NCT01480635|"~     Purpose of study:~      To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard~     colonoscopy~      Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects~      Subject population: Patients that are indicated for colonoscopy, who are suspected or known~     to suffer from colonic diseases and had an incomplete standard colonoscopy~      Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One~     week follow up Duration of study: 12 months~      Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon~     segment not reached by an incomplete standard colonoscopy Evaluation of distribution of~     excretion of capsules over time~   "
159329|NCT01480622|"~     This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF)~     300 mg in Chinese subjects to support the registration of this compound in the People's~     Republic of China. This will be an open-label, single group, single and repeat dose study~     without placebo in healthy male and female subjects. Pharmacokinetic sampling to enable~     measurement of plasma concentrations of tenofovir will be conducted over a 60-h period after~     the single dose and at steady state. The duration of the study will be approximately 7 weeks~     from screening to follow-up.~   "
159330|NCT01480609|"~     This in an open-label, single dose, fixed sequence, two treatment period study enrolling 8~     patients (to obtain 6 evaluable) with end stage renal disease (ESRD) receiving haemodialysis.~     Patients will remain in the unit during each treatment period from admission to the~     collection of the final PK sample. The doses of ezogabine/retigabine in the two treatment~     periods will be separated by at least 7 days.~   "
159331|NCT01480596|"~     Study BEL115123 is a randomized, placebo-controlled, double-blind, multinational study of~     belimumab (10 mg/kg) to investigate the efficacy and safety of belimumab in subjects with MG.~     The study will enroll male and female outpatients (> or equal to 18 years of age) with a~     diagnosis of MG who are 1) acetylcholine receptor (AChR) antibody positive or muscle specific~     kinase (MuSK) antibody positive, 2) on current standard of care therapy, and 3) continue to~     exhibit signs of MG. The study will include 3 phases: a 4 week screening period, a 24 week~     treatment period, and a 12 week follow-up period. IP will be administered intravenously on~     Days 0, 14, 28 and then every 28 days through and including Week 20. At Week 24, primary~     outcomes will be obtained. Follow up evaluations will be conducted at Weeks 28, 32 and 36 for~     all subjects. The primary objective of this study is to assess the efficacy of belimumab as~     evaluated by the change in the quantitative myasthenia gravis (QMG) score.~   "
159332|NCT01480583|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in~     patients with brain metastases from breast cancer. For patients with HER2 positive metastatic~     breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per~     standard-of-care practice.~      In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of~     change in the uptake in the brain metastases from breast cancer after GRN1005 treatment,~     correlates with intra-cranial response (for patients enrolled at NCI).~   "
183260|NCT01166074|"~     This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants~     less than two years old.~   "
159333|NCT01480557|"~     Objective of this study is the comparative assessment of the impact of torsional and~     liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal~     sensitivity (CCS) in a sample of cataract patients.~      Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible~     basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear~     opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale~     [10]. By means of a custom computer randomization program all participants randomly populated~     two study groups according to the cataract-extraction technology used: a) Torsional group~     (TG) and b) Liquefaction group (LG).~   "
159334|NCT01480544|"~     The study evaluates the impact of a new conditional cash transfer (CCT) program (Thayi Bhagya~     Yojana) to promote child birth in obstetric facilities in the state of Karnataka, India in~     order to determine its policy value and to guide efforts to improve maternal and infant~     health outcomes nationally. In addition, the study includes a large randomized evaluation of~     performance-based incentive payments to providers to improve quality of medical care provided~     during delivery and actual health improvement in the providers' patient populations and their~     catchment areas.~   "
159335|NCT01480531|"~     2. Purpose of the Study -~        1. To determine the feasibility of Clevidipine use for rapidly achieving and maintaining~          individually specified patient BP target ranges in the pre and postoperative periods of~          aortic aneurysm and dissection management.~        2. To determine the safety of Clevidipine use in the pre and postoperative periods of~          aneurysm and dissection management~        3. Background & Significance - Surgical treatments for persons with aortic root/arch~          dissection or aneurysm have significantly improved survival. However, critical in~          management of these patients is precise control of blood pressure (BP). With increasing~          BP, both acute and chronic, the risk of fatal and nonfatal vascular complications is~          imminent. Similarly, with excessive lowering of arterial pressures, cerebral, spinal~          cord, cardiac, and renal ischemic hypoperfusion is also noteworthy. Typically, the~          target systolic blood pressure range for these patients is 100-120 mmHg.~           Several different classes of vasoactive agents are in current use to acutely manage BP~          but none possess the optimal profile of an ideal vasodilator. Notable limitations~          include inadequate potency, slow onset and offset of action, multiple receptor function,~          safety concerns and, importantly, restricted/ineffective titration, which results in~          clinically significant hemodynamic and cardiovascular perturbations.~           Recently, the ultra short-acting intravenous dihydropyridine calcium-channel blocker~          clevidipine (Cleviprex, The Medicines Company) was approved for management of BP in~          critical care settings.~           Clevidipine's pharmacology lends itself to acute management of BP in a broad critical~          care setting in both surgical and nonsurgical patients. In the current study, the~          investigators propose to further characterize the hemodynamic effect of CLV in the pre~          and post-operative management of BP in patients with aortic aneurysm/dissection.~        4. Design & Procedures Eligible patients will be approached to participate in the study by~          the Intensive Care Unit (ICU) attending and/or by a cardiothoracic~          surgical/anesthesiology fellow or a cardiac research nurse. All aspects of clinical~          management and monitoring will be according to standard practice that includes:~             -  ECG~             -  Oxymetry~             -  Temperature~             -  Invasive arterial blood pressure~             -  Recording of routine laboratory results~             -  Imaging studies including CT/MRI (A)/ Echocardiography~             -  Pulmonary artery catheter (postoperative patients)~             -  Mechanical ventilation (postoperative patients)~             -  According to established protocol for acute intravenous management of arterial~               blood pressure in these patients, an upper and lower threshold of systolic blood~               pressure will be prescribed by the attending physician (the range being (100 mmHg~               -120 mm Hg SBP).~      Hemodynamic data will be collected continuously via a bedside laptop as well as pertinent~     clinical data and information about efficacy and safety will be recorded.~      • Subjective evaluation of efficacy of CLV (questionnaire format to be completed by the~     critical care team)~   "
159336|NCT01480518|"~     RATIONALE: Studying samples of tissue in the laboratory may help doctors learn more about~     changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors~     understand how well patients respond to treatment.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     Ewing sarcoma.~   "
159337|NCT01480505|"~     Purpose:~      To assess the functional and anatomical outcome of primary vitrectomy without scleral~     buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length~     over 30 mm.~      Methods Design: Retrospective single center series. Setting: University Hospital. Patients:~     High myopic patients treated with primary vitrectomy without scleral buckling for a~     rhegmatogenous retinal detachment.~      Outcome measures: Anatomical success rate with complete reattachment of the retina without~     silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).~   "
159338|NCT01480492|"~     During hepatitis B virus(HBV) infection host immune plays important role.Recently there are~     many different antiviral therapy methods.Different antiviral therapy methods showed different~     effector.In order to investigate whether these antiviral therapy methods especially methods~     directly inhibit viral replication have some effect on host immune the investigators designed~     these study. The investigators want to observe the change of host immune during antiviral~     therapy in patients with chronic HBV infection, and analyze the relationship between these~     changes and the antiviral effector of these drugs.~   "
159339|NCT01480479|"~     This 2-arm, randomized, phase III study will investigate the efficacy and safety of the~     addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer~     effects in patients who have tumors that express the EGFRvIII protein) to the current~     standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of~     brain cancer.~      All patients will be administered temozolomide, the standard treatment for glioblastoma. Half~     the patients will be randomly assigned to receive rindopepimut and half the patients will be~     randomly assigned to receive a control called keyhole limpet hemocyanin.~      Patients will be treated in a blinded fashion (neither the patient or the doctor will know~     which arm of the study the patient is on). Patients will be treated until disease progression~     or intolerance to therapy and all patients will be followed for survival.~   "
159340|NCT01480466|"~     Overweight and obesity are highly significant clinical and public health issues, affecting~     more than two-thirds of adults in this country; however, primary care clinicians often do not~     document overweight or obesity or discuss weight management with their patients. The~     objectives of the proposed research are to develop and evaluate a set of tools within~     electronic health records (EHRs) to assist primary care clinicians with the diagnosis and~     treatment of overweight and obesity and to help patients manage their weight.~   "
159341|NCT01480453|"~     The objectives of this study are to obtain survival and outcome data on the Trabecular Metal~     Humeral Stem when used in primary, total or hemi shoulder arthroplasty.~   "
159342|NCT01480440|"~     The objectives of this study are to obtain survival and outcome data on the Trabecular Metal~     Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.~   "
159343|NCT01480427|"~     The purpose of this study is~        1. To validate in french quality of life questionnaires for food allergic children~        2. To evaluate if the quality of life of food allergic french speaking children aged 0-12~          years is affected by their condition~        3. To validate a didactic game for food allergic children~   "
159344|NCT01480414|"~     Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb~     perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic~     needs of the tissue, even under resting conditions. The limits of peripheral artery disease~     (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have~     been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults~     older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of~     collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the~     pathophysiology of vascular disease. By stimulating these processes the investigators might~     be able to provide an alternative treatment strategy for patients with lower limb ischemia.~     In response to tissue injury and remodeling, neovascularization usually occurs via the~     proliferation and migration of progenitor endothelial cells (EPC) from preexisting~     vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC)~     implantation increases collateral vessel formation in patients with limb ischemia. So the~     investigators determine to evaluate the efficacy of repeated MNC transplantation in patients~     with ischemic lower limb.~   "
159345|NCT01480401|"~     This study aims to identify the relationship between a low-sodium diet and neurohormonal and~     clinical status in stable chronic HF patients.~   "
159346|NCT01480388|"~     The purpose of the study is to assess the efficacy, safety and tolerability of JNJ-39758979~     at doses of 10, 30, 100, and 300 mg/day compared with placebo (inactive medical substance) in~     patients with active rheumatoid arthritis despite concomitant treatment with methotrexate~     (MTX).~   "
159347|NCT01480375|"~     he most common method for performing a prostate biopsy procedure is the ultrasound guided~     transrectal procedure. The information obtained from the standard prostate biopsy is~     deficient and even misleading. Cancers can be missed on initial and even in repeated biopsy.~     Moreover, the detection of a tumor cannot predict accurately the tumor size and location1. It~     was proven that the exact location of the obtained cores, even in an initial biopsy, can~     influence the cancer detection rate2.~      An imaging tool that will enable a three-dimensional navigation in the prostate volume and~     selecting biopsy locations in view of previous core taken will allow building a tumor map~     '(i.e. detecting tumor size and location). By mapping the prostate cancer an adequate~     treatment can be chosen while avoiding over or insufficient treatment.~      However, to be able to produce an accurate mapping of the malignant tissue, a complementary~     optimized pathology method should be also implement in addition to the navigation system, it~     has been shown that a pre-embedding procedure that keeps the specimen orientation, unfolding,~     unity, and location along the needle notch improves the histological yield and hence the~     cancer detection rate3.~      The NaviGo™ Workstation (hereafter the NaviGo™ Workstation or the NaviGo™ System) allows~     physicians to see the prostate gland together with the biopsy sites in a three dimensional~     (3D) view, modeled from two dimensional (2D) images. The NaviGo™ Workstation was designed as~     an adjunct to standard of care procedures, to work with standard rectal ultrasound probes,~     and to be incorporated side by side with the techniques currently employed. No change to the~     current employed procedures and techniques is required or suggested. In complementary to the~     Navigo system a system for semi-automatic download of prostate biopsy cores which keeps the~     orientation, unfolding and unity of the sample was developed to increase the pathology~     utility.~      The study objective is to evaluate the contribution of the Navigo™ system, an aiding~     navigation tool for TRUS prostate biopsy, to an increase in the prostate cancer detection~     ability.~   "
159348|NCT01480362|"~     On behalf of a consortium of 19 health insurance companies the Institute for Research in~     Operative Medicine as part of the University of Witten / Herdecke gGmbH is planning and~     conducting a clinical study evaluating the efficacy and effectiveness of negative pressure~     wound therapy in the treatment of wound healing disorders of the foot, which are caused by~     diabetes mellitus.~      This german multicenter study is due to evaluate whether the negative pressure wound therapy~     or the control therapy (standard wound therapy following the guidelines) is superior.~      Patients will be randomly assigned to the two study arms. Both patients and the treatment~     staff know about the specific allocation to the negative pressure wound therapy or standard~     wound therapy arm.~      A photo documentation and a computer-based evaluation of the wound images will be performed.~     This is done centrally by independent examiners, who don`t know neither the patient nor the~     treatment assignment.~      It is believed that the application of the negative pressure wound therapy systems compared~     to standard therapy of diabetic foot wounds will lead more frequent and more rapid to the~     achievement of complete wound closure and that the use of negative pressure wound therapy is~     an effective and safe therapy option for the treatment of diabetic foot wounds in inpatient~     and outpatient care.~      Patient´s to be included into the study should have either a chronic diabetic foot wound~     existing longer than 4 weeks whereas dead tissue components must be completely removed by the~     doctor or a wound after amputation of foot parts.~      The study treatment may have already started in the hospital if applicable. The further wound~     treatment will be mainly performed within outpatient care. Study Participants will return to~     the study centre for regular study visits or even for wound treatment.~      The comparison of the outcomes of both study arms will give valuable information about the~     efficacy of negative pressure wound therapy in inpatient as well as outpatient care. These~     results should be provided until the end of 2016 as a basis for the decision of the Federal~     Joint Committee to answer the question if the negative pressure wound therapy can be approved~     as a standard service for reimbursement by health insurance companies.~   "
159349|NCT01480349|"~     This multicenter, prospective pilot study will compare the effectiveness of two established~     procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight~     infants, specifically ventricular reservoirs and subgaleal shunts. The study is being~     conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to~     conduct multi-institutional clinical trials on pediatric hydrocephalus.~   "
159350|NCT01480336|"~     The purpose of this study is to learn if combination therapy with amiodarone and ranolazine~     (an approved drug for chest pain) can help prevent arrhythmias.~   "
159351|NCT01480323|"~     The current clinical trial shall clarify a synergistic effect with regards to efficiency by~     the combination of intratumoral injection of interleukin-2 (IL-2) and the intra-venous~     application of ipilimumab.~   "
159352|NCT01480310|"~     This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose (SAD)~     study in male and female healthy volunteers, aged 18-55 years, enrolled at a single study~     site in Canada.~   "
159353|NCT01480297|"~     This 12 week study will examine the effects of daily Salsalate treatment on markers of~     neuropathic pain and intra-epidermal nerve fiber density. the study is being done in people~     with type 1 diabetes with signs and symptoms of peripheral neuropathy.~   "
159354|NCT01480284|"~     The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered~     once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis~     B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to~     ETV will be verified using the antiviral effect as the index.~   "
159355|NCT01480271|"~     GSK2245035 is a highly selective Toll-like Receptor 7(TLR7) agonist capable of preferentially~     inducing the production of interferon alpha (IFNα) versus tumor necrosis factor alpha (TNFα).~     The aim of this FTIH study is to collect tolerability, pharmacokinetic (PK) and~     pharmacodynamic (PD) information to enable the identification of appropriate safe doses of~     intranasal (i.n) GSK2245035, associated with up-regulation of TLR7-mediated genes in the~     nasal milieu, for use in subsequent clinical drug development studies. There will be two~     parts to the study: Healthy Volunteers will be dosed in escalating single doses in Part 1,~     followed by Allergic Rhinitis (AR) subjects dosed similarly in Part 2.~   "
159356|NCT01480258|"~     This study will determine whether subjects who receive V419 at 2, 4, and 11 to 12 months of~     age have an acceptable response to the vaccine. this study will also determine whether the~     immune response to V419 is similar to that of subjects who received a licensed vaccine~     control.~   "
159357|NCT01480245|"~     The purpose of this study is to explore long-term safety, tolerability and efficacy of~     GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.~   "
159358|NCT01480232|"~     This study is designed to evaluate the initial evidence for efficacy of the investigational~     medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper~     of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers~   "
159359|NCT01480219|"~     The primary objective of the study is to assess the relationship (both crude and adjusted)~     between voriconazole utilization and the development of non-melanoma skin cancer among adult~     patients who received a lung or heart/lung transplant and were continuously enrolled in a~     large U.S. commercial health plan.~   "
159360|NCT01480206|"~     As endovascular procedures become more complex, there is a growing need for 3D image overlay~     to assist with device guidance and placement. Currently, a 3D image is typically created~     intra-operatively using 3D rotational angiography (3D-RA) or cone-beam CT (XperCT). This 3D~     image may then be overlaid on live fluoroscopy to provide 3D guidance information (Dynamic 3D~     Roadmapping). Philips Healthcare multimodality overlay products allows registration of a~     pre-acquired MR/CT or 3D rotational image to live fluoroscopy.~   "
159361|NCT01480193|"~     Tinnitus is a common problem for which there is no universally effective treatment. The best~     available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but~     only 20% of those who report tinnitus suffer from it and subsequently seek treatment. Only~     formally reported by the U.S. Department of Veterans Affairs (VA), the economic impact of~     tinnitus is thought to be substantial. The VA reported in 2004 that 289,159 veterans received~     a disability award for their tinnitus amounting to a total annual compensation amount of over~     $345.5 million. Individuals with persistent severe tinnitus are unable to habituate to the~     tinnitus sound that most likely originates in the central auditory system (CAS) in response~     to peripheral injury. In a widely referenced study, it has been hypothesized that lack of~     habituation is secondary to abnormal processing of sensory information. Specifically,~     processing by the limbic system and autonomic nervous system is apparently abnormal in~     patients with increased levels of cortical arousal and inadequate coping mechanisms. In~     otolaryngology and audiology clinics, 'sound-based and educational therapies' (SBE) are the~     focus of most current therapies, and utilize enhanced sound input to the CAS. While SBE~     treatments may well provide a starting point for tinnitus treatment, additional treatment~     options are necessary particularly for those with significant non-auditory aspects of~     tinnitus (e.g., anxiety, depression, interference with daily life) as well as for those who~     do not experience significant improvement with SBE. Furthermore, commonly used forms of SBE~     [e.g.,Tinnitus Retraining Therapy (TRT)] can require over a year to become effective and may~     not be used in patients with hearing that is too poor to be modified by sound input. Based on~     prevalence data from tinnitus sufferers who seek treatment and the known percentage who do~     not respond to commonly used therapies, we estimate that 1.2 million individuals are not able~     to benefit at all from current, widely used treatment strategies. A new strategy to augment~     those currently used could empower patients to exert control over their tinnitus symptoms~     without the use of medications, expensive devices such as the Neuromonics device, or extended~     programs such as TRT. An alternative strategy may be useful both for patients who are not~     candidates for SBE and for those who respond poorly. An Integrative Medicine approach~     provides a likely solution. To date, there has been no systematic study of the benefits of an~     Integrative Medicine approach for severe tinnitus, particularly for non-auditory aspects of~     tinnitus symptoms. The goal of the proposed study is to determine if an integrative medicine~     approach which targets treatment of the nonauditory aspects of tinnitus suffering is more~     effective in alleviating tinnitus symptoms when added to current commonly applied SBE~     therapies, compared with SBE alone. If successful, this approach will be applied to a larger~     patient population in future studies to test the generalizability and the durability of the~     effect. Our eventual goal is to develop a streamlined approach that individualizes tinnitus~     treatment based on symptoms and patient characteristics, and that can be widely applied in~     general medical practice.~   "
159362|NCT01480180|"~     This trial is conducted globally. The aim of the trial is to evaluate the safety and~     efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC~     0129-0000-1003 (N8-GP) in subjects with Haemophilia A.~   "
159365|NCT01480141|"~     This study is for patients that have Non-Small Cell Lung Cancer (NSCLC) and he or she will~     have surgery to remove the tumor. The main purpose of this study is to study how safe and~     suitable treatment with Afatinib is in participants before surgery to remove the tumor.~     Another goal of the study is to see if treatment with Afatinib affects the growth and~     activity of the tumor. Afatinib has not been approved for use by the FDA (Food and Drug~     Administration) and is experimental.~      In some persons, the growth of cancer cells is thought to be stimulated by Epidermal Growth~     Factor (EGF). This is a protein found in the body which binds to the cell wall to sites~     called receptors and stimulates cell growth. Some cells have too many receptors and~     uncontrolled growth and because of this, develop into a cancer tumor. There are several other~     cancer drugs that bind to these receptors to slow or stop cancer growth such as Gefitinib and~     erlotinib which are FDA approved and used for the treatment of NSCLC.~      The drug Afatinib has been shown to inhibit mutated EGF receptors in clinical trials and may~     be a candidate for the treatment of NSCLC and a variety of early stage cancers. Participants~     in this study will take Afatinib by mouth, in pill form, for at least 14 days before having~     their scheduled surgery to remove their cancer tumor. Participants will be observed for side~     effects and followed for 30 days after surgery to assess the results after surgery.~   "
159366|NCT01480128|"~     This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy~     for colon cancer treatment, in terms of safety, efficacy, and cost.~      The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to~     multiport laparoscopic colectomy.~   "
159367|NCT01480115|"~     The ultrasound unit in Meir Medical Center developed new software to automated ovarian~     follicle count on the basis of 3D US. The investigators intent to evaluate this software at~     two steps:~        -  To compared the abilities of the software to physician follicle count.~        -  To evaluate with the software the antral follicle count, as expression to ovarian~          reserve at 3 different time of the month.~      The investigators believe that the software measurement of the small follicle can be better~     than the common antral follicle count that is use today, and by this accurate evaluation of~     the small follicle the investigators can evaluate the ovarian reserve at any time of the~     mount, and not only at the early follicular phase that use today.~   "
159368|NCT01480102|"~     This study will compare post-operative pain levels in patients who receive paravertebral~     block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive~     the block. We hypothesize that patients who receive the block will have lower post-operative~     pain scores and require less narcotics.~   "
159369|NCT01480089|"~     The purpose of this trial is to determine the effect of spraying a local anesthetic called~     Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a~     local anesthetic used to block pain in the body. There are studies showing that Ropivacaine~     decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder~     removal but has not been tried in robotic pelvic surgery.~   "
159370|NCT01480076|"~     The primary objective of the study is to assess the effect of long-term treatment with~     prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale~     (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment~     responders. The secondary objectives of this study are to compare the change in the PCS of~     the SF-36 between treatment responders and non-responders, to evaluate change from baseline~     in additional quality of life measures among treatment responders as well as changes from~     baseline in treatment responders versus non-responders and to assess the safety and~     tolerability of prolonged-release fampridine 10 mg twice daily.~   "
159371|NCT01480063|"~     The primary objective of the study is to collect additional safety data including the~     incidence rate of seizure and other specific Adverse Events (AEs) of interest from~     participants taking Fampyra in routine clinical practice. The secondary objectives of this~     study are to characterize utilization patterns of Fampyra in routine clinical practice, to~     assess the effectiveness of risk minimization measures as described in the risk management~     plan for Fampyra, to assess the change over time in participant self-reported evaluation of~     the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to~     assess the change over time in physician assessment of walking ability in participants taking~     Fampyra (MS participants only).~   "
159372|NCT01480050|"~     RATIONALE: Mibefradil dihydrochloride may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing.~      PURPOSE: This phase I trial is studying the best dose of mibefradil dihydrochloride when~     given together with temozolomide in treating patients with glioma.~   "
159373|NCT01480037|"~     The present study proposes the characterization of sleep patterns of healthy young adults,~     elderly individuals and individuals above 85 years old, using polysomnographic recordings, in~     order to clarify the importance of sleep in longevity. Furthermore, this study intends to~     analyze the oxidative stress-related gene expression in peripheral blood of the three studied~     groups, using the Superarray - RT2 Profiler PCR Array System. After the identification of~     genes whose expression pattern among groups suggest a more specific role in longevity, the~     mechanisms of gene expression regulation, including DNA methylation patterns and microRNA~     expression, as well as the possible genomic sources of variation in these genes will be~     investigated. In addition, the oldest individual (105 years-old) will have his whole genome~     sequenced using next-generation sequencing technology, in order to identify rare variants~     associated with longevity. Subsequently, the effect of the polymorphisms and rare variants~     identified will be confirmed in an expanded sample constituted of individuals with various~     age-ranges. The study will provide a better characterization of molecular and physiological~     mechanisms involved in longevity, hoping to contribute to the development of more advanced~     clinical tools, capable to offer a better quality of life for the elderly.~   "
159374|NCT01480024|"~     The investigators will test the hypothesis that obese women have a unique oocyte gene~     expression profile that differs significantly from that of normal weight women.~   "
159417|NCT01479465|"~     This randomized study compares the efficacy of simtuzumab (GS-6624) versus placebo in~     combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in~     participants with metastatic KRAS mutant colorectal cancer.~   "
159375|NCT01480011|"~     Patients with various malignancies who are taken up for high dose chemotherapy followed by~     stem cell transplant (blood and marrow transplant) have very high chances of developing~     severe oral mucositis (between 95-100%). This mucositis not only causes significant morbidity~     but also hampers quality of life so much so that patients at times feel difficult to continue~     treatment.~      No definite treatment exists for prevention or treatment of oral mucositis in this group of~     patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth~     factor) will reduce duration and severity. Palifermin is very expensive and not available in~     country. Recently the investigators have shown effectiveness of a probiotic Lactobacillus CD~     2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck~     squamous cell cancer patients. (Published online in European Journal of Cancer:~     http://dx.doi.org/10.1016/j.ejca.2011.06.010). No significant toxicity has been reported with~     its use.~      Now, the investigators want to study the efficacy of this drug to reduce severity of~     mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be~     supplied by CD Pharma India Private Limited.~      The investigators further give undertaking that study will be carried as per good clinical~     practices (GCP) and declaration of Helsinki.~   "
159376|NCT01479998|"~     Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling~     sessions and nicotine replacement therapy (NRT)) or 2) standard care + contingency management~     (i.e., 4 counseling sessions and NRT + 3x/week meetings with positive reinforcers)~   "
159377|NCT01479985|"~     The purpose of this study is to conduct a randomized clinical trial of a web-based~     contraceptive decision aid compared to routine contraceptive counseling to evaluate the~     effect of the contraceptive decision aid on the contraceptive method selected by the~     participant.~      The investigators primary hypothesis is that women utilizing a computerized Contraceptive~     Decision Aid (CDA) will be more likely to choose highly effective contraception than women~     who undergo standard clinical contraceptive counseling.~   "
159378|NCT01479972|"~     Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing~     BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against~     tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas.~     The new vaccine should be at least as potent as the current strain and should be safer than~     BCG (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised~     bacteria to be re-suspended before intradermal injection. The preceding clinical trials in 80~     volunteers in Germany and 24 volunteers in Bloemfontein, South Africa indicated~     immunogenicity and safety being sufficient for proceeding with the clinical development in~     newborn infants. Hence, the current study is commenced at Stellenbosch University, South~     Africa. This is the first investigation of VPM1002 in newborn infants.~   "
159379|NCT01479959|"~     Adequate communication is a major part of the quality of life of tracheostomized ventilator~     dependent patients. Maintaining speech is therefore major goal in the management of these~     patients.~      The use of a positive end-expiratory pressure (PEEP) during ventilation has allowed the~     improvement of speech. The best level for speech may vary from one patient to the other The~     purpose of this study is to determine individually the most efficient PEEP level in terms of~     speech while obtaining the most secure condition and the best possible respiratory tolerance.~     In order to improve the latter, the investigators will use a device which allows the patients~     to control the activation of PEEP so that they can use it only when needed (i.e. when they~     wish to speak). The investigators will compare the effect of different PEEP level to try to~     determine the best compromise to improve speech in tracheostomized ventilator-dependent~     patients.~   "
159380|NCT01479946|"~     Electroporation combined with chemotherapy (ECT) has been shown to be an effective treatment~     for breast cancer that has spread to skin. In routine clinical practise, ECT is offered to~     patients when all other treatment options have been exhausted. This study tests the~     hypothesis that early treatment with ECT may result in improved local control of skin~     metastases, improved quality of life and reduced health care costs. Patients are randomised~     to either ECT given as early as possible in the course of the disease or delaying ECT for at~     least 6 months.~   "
159381|NCT01479933|"~     Vitamin D deficiency is widespread throughout the world, and the deficiency has been~     associated with several chronic diseases, such as cardiovascular diseases and diabetes. In~     Nordic countries, like in Finland, there is a particular variation in vitamin D status, and~     during wintertime, when there is no exposure to ultraviolet-B light from the sun, serum~     concentrations of vitamin D decrease substantially. In Finland, some 40% of middle-aged men~     and one third of women also have some degree of impairment of glucose metabolism.~      The purpose of this trial is to investigate the effects of two different daily doses of~     vitamin D on glucose metabolism in men 60 years of age or older and who are vitamin D~     deficient, have a high body mass index and at least two characteristics of cardio-metabolic~     syndrome.~      Altogether 102 subjects with low serum calcidiol (<60 nmol/L) will be recruited and~     randomized to one of the three groups: 1) 40 µg/d vitamin D3, 2) 80 µg/d vitamin D3 or 3)~     placebo. The supplementation period will last for 6 months from September 2011 to March 2012.~      The main hypotheses of the trial are: (1.) Vitamin D supplementation will improve glucose and~     insulin metabolism in people with a low baseline vitamin D status, in a dose-dependent~     manner. (2.) Vitamin D supplementation will have an effect on the expression of genes~     involved in glucose and insulin metabolism and inflammation. (3.) Vitamin D supplementation~     will have an effect on epigenetic changes in key genes participating in vitamin D metabolism.~   "
159382|NCT01479920|"~     This is a randomized, assessor-blind, placebo controlled study in major depressive disorder~     (MDD) patients. Subjects receiving antidepressant drug (FLX) would be assigned to receive~     either 18 sham / active DCEAS for in 6 weeks. Changes in the severity of depressive symptoms~     over time are measured using depression rating scales. Brain glucose metabolic levels are~     measured using PET at baseline and endpoint. The most intriguing and expected result might be~     that acupuncture treated-patients may display comparable or even better outcomes and the~     clinical improvements by acupuncture are correlated with the restoration of the activities in~     the related brain regions.~   "
159418|NCT01479452|"~     The purpose of the Swedish Obese Subjects (SOS) study is to examine the long-term effects of~     bariatric surgery on overall mortality and obesity-related co-morbidities.~   "
183579|NCT01161914|"~     The purpose of this study is to compare and evaluate the efficacy and safety of ISU302, an~     investigational product, and Cerezyme®, comparator, for Type 1 Gaucher Disease patients~   "
159383|NCT01479907|"~     The aim of this double-blinded prospective randomised trial is to explore the potential~     benefits of early postoperative administration of Synbiotics (combination of prebiotics and~     probiotics) to patients who have undergone colectomy for cancer. The patients are randomised~     to either synbiotics or placebo administration at the day they are able to tolerate po liquid~     diet and for 15 days thereafter.~      Primary end points of the study will be:~      Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months~     postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of~     Life Index)~      Secondary end points will be:~      -Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months~     postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30~   "
159384|NCT01479894|"~     This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the~     distribution of Recurrence Score® and gene groups of stage II colon cancer in African~     American (AA) and Caucasian individuals. Other covariant factors in the medical chart will be~     analyzed as well. Three institutions will contribute patients to this study with a total~     patient number goal of approximately 200 with approximately 100 being AA and approximately~     100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be matched~     for every African American enrolled.~   "
159385|NCT01479881|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 (administered once a day) on the single-dose pharmacokinetics of the~     immunosuppressants cyclosporine and tacrolimus in healthy participants. Cyclosporine and~     tacrolimus are immunosuppressants used to prevent transplant rejection and may therefore~     potentially be coadministered with TMC435 in patients infected with hepatitis C virus that~     undergo liver transplantation. We will also explore the short-term safety and tolerability~     following coadministration of TMC435 at steady-state and (1) cyclosporine or (2) tacrolimus~     after single dosing in healthy participants. Steady-state is a term that means that the drug~     has been given long enough so that the plasma concentrations will remain the same with each~     subsequent dose. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream,~     distributed in the body and eliminated from the body.~   "
159386|NCT01479868|"~     The purpose of this study is to evaluate the safety and tolerability of TMC435 along with~     pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C~     virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and~     to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after~     the planned end of treatment.~   "
159387|NCT01479855|"~     The purpose of the study is to compare the concentrations of Vitamin B1 (thiamine), Vitamin~     B6 (pyridoxal-5-phosphate), folate, Vitamin B12 (cobalamin), Vitamin C (ascorbic acid),~     Vitamin A (retinol), Vitamin E (alfa-tocopherol), homocystein, uric acid, F2 8-α-isoprostane,~     8-deoxyguanosine, retinoids, tau-protein and β-amyloid in spinal fluid, metabolomics,~     proteomics, m-RNA for DNA repair enzymes and DNA in patients who suffer from mild cognitive~     impairment (MCI) or mild dementia of Alzheimers type, with healthy controls.~      A second aim is to explore the association between vitamin and nutrient reductions, if any,~     and cognitive function as well as vascular score and possible changes in the MRI.~   "
159388|NCT01479842|"~     This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when~     given together with rituximab and bendamustine hydrochloride in treating patients with~     recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some block the ability of cancer to~     grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving BTK inhibitor PCI-32765 together with rituximab and bendamustine~     hydrochloride may kill more cancer cells.~   "
159389|NCT01479829|"~     This project will attempt to enhance and augment the antidepressant efficacy of a commonly~     used antidepressant in poorly responding bipolar depressed patients.~   "
159390|NCT01479816|"~     This study will analyse existing data to establish a clinically useful index to predict those~     women who are more likely to become incontinent. This would create significant opportunities~     for focused prevention and early intervention strategies.~   "
159391|NCT01479803|"~     The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS) for~     the diagnostic of solid pancreatic masses is 70% on average in the current literature with 22~     gauge needles. There is a wide variability of this rate across studies (from 38 to 92%). In~     case of negativity of the biopsy, the risk of missing a pancreatic cancer whose prognosis is~     severe and extensive treatment, remains important. To improve the sensitivity of EUS echo~     endoscopy, several methods were used. A new needle (Echo Tip ® HD ProCore ™) has received CE~     Mark in the field of EUS. This instrument combines the comfortable and handy size of 22 Gauge~     and innovative design (window lateralized bevel) with in vitro studies obtaining core biopsy.~     In addition, a single pass through the tumor is achieved with this hand against several (2-3~     minimum) with the current hardware. The theoretical goal is to have a tissue material more~     abundant during the sampling, without increasing morbidity and increase the diagnostic~     accuracy. A preliminary prospective study with this material has shown interesting results~     (increase the diagnostic accuracy of 15%).~      To determine the diagnostic gain with this new hand, it seemed essential to propose a~     prospective comparative study (22 gauge needle ProCore ™ versus the old EchoTip ® 22-Gauge)~     randomized (randomization of the order of the needles) in crossover (on the same lesion) in~     samples of pancreatic solid tumors. The caliber of 22 gauge is the gauge most often used for~     punctures under ultrasound endoscopy, resulting in less morbidity. Puncture by the 2 needles~     on the same injury can limit the effect of variability between patients and thereby have a~     better power for the investigators study without increasing the risk of complications (the~     needle ProCore ™ does not require that one pass through the tumor). The study of pancreatic~     solid tumors is one that poses the biggest diagnostic problem still present in the~     investigators daily practice. The aim of this study is to compare the diagnostic accuracy of~     the needle ProCore™ versus EchoTip® in etiological cyto histological diagnostic for~     pancreatic solid tumors under EUS.~   "
159419|NCT01479439|"~     Sickle cell disease causes kidney damage with increasing age, leading to chronic kidney~     disease and renal failure in nearly one third of patients with sickle cell disease.~     Currently, there is no treatment for sickle cell related kidney disease.~   "
159420|NCT01479426|"~     Korea red ginseng has been used in maintaining vitality throughout the globally and~     metabolism and actions on neurologic, cardiovascular, and endocrinologic system are studied.~     KRG has been used in various ailment, and to prove its efficacy for erectile dysfunction an~     international study on contries other than Korean was performed. In the present study,~     subjects with borderline organic and psychogenic erectile dysfunction will be included. KRG~     will be give daily, and placebo will be give as control. Outcomes including libido, erection,~     sexual activity, and sexual satisfaction will be measured.~   "
159392|NCT01479790|"~     Dry eye is a common condition that affects vision and quality of life in patients. Dry eye~     clinical research is limited to follow up of disease progression. Currently, most research~     outcomes are based on subjective patient complaints rather than objective assessment of the~     condition. Only few objective measurements for dry eye are available today and this is mainly~     the result of poor repeatability and inaccuracy.~      This current study aims to evaluate 2 new non-invasive imaging techniques suitable for dry~     eye assessment.~      Anterior segment optical coherence tomography (AS-OCT) is an imaging device that has the~     ability to image the tear meniscus of the eye in a safe and non-invasive manner. Image~     analysis can then indirectly determine the tear film volume. Improvements in the image~     resolution of these devices require a study that compares the repeatability and agreement of~     an older (Visante AS-OCT) and a newer instrument (Cirrus AS-OCT) which the current study aims~     to address.~      Another method of evaluating dry eye disease is a novel technique that uses functional~     infrared thermography to measure tear evaporation rate. This study will also establish~     repeatability of measurements of the ocular surface temperature which are used to calculate~     tear evaporation rates.~      Should these methods are found to be repeatable, they can be used in future clinical trials~     as an additional tool to investigate dry eye treatments.~   "
159393|NCT01479777|"~     The research is being done to find out if Functional Electrical Stimulation (FES) stepping~     can improve the function of people with spinal cord injury that paralyzes.~   "
159394|NCT01479764|"~     This study will compare the incidence of residual neuromuscular blockade in participants who~     undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo~     reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).~   "
159395|NCT01479751|"~     In this study, methods which are known for facilitating rapid sequence intubation or~     accelerating rocuronium (Roc)onset are compared including magnesium (Mg), ketamine~     pretreatment, large dose rocuronium and priming.~   "
159396|NCT01479738|"~     The capitate had a widened distal base. The distal articulation can be used for proximal~     interphalangeal (PIP) articula reconstruction.~   "
159397|NCT01479725|"~     To review the results of Hyperbaric Oxygen therapy (HBOT) on the symptoms of interstitial~     cystitis (IC). To determine if there is greater symptom improvement in the ulcerative vs the~     non-ulcerative patients with interstitial cystitis.~   "
159398|NCT01479712|"~     The purpose of this study is to determine if intra-abdominal irrigation at the time of~     cesarean delivery increased maternal GI discomfort without affecting infection rates.~      We hypothesized that avoiding intra-operative irrigation at the time of cesarean delivery~     will decrease intra-operative nausea and vomiting without increasing maternal infectious~     morbidity, post-operative pain, return of bowel function, or time to discharge.~   "
159399|NCT01479699|"~     The purpose of this study is to determine how olive leaf is absorbed and metabolised and also~     whether it has any effect on the elasticity of blood vessels and the immune system.~   "
159400|NCT01479686|"~     Many clinical studies have been reported on iMRI, however, their evidence levels are~     relatively not as good as what people hope they will be. Based on the available literature,~     there is, at best, level 2 evidence that iMRI-guided surgery is more effective than~     conventional neuronavigation-guided surgery.~      The investigators aim to do a single center prospective randomized triple-blind controlled~     clinical trial to assess the effect of 3.0T high-field intraoperative MRI-guided glioma~     resection on surgical efficiency and progression-free survival of malignant glioma to provide~     a level 2A evidence for its clinical application.~   "
159401|NCT01479673|"~     The aim of this study is to perform a prospective, randomized, controlled blinded study in~     critically patients to assess the necessity for measuring daily resting energy expenditure as~     a guide for nutritional support. Our hypothesis is that tight caloric control will reduce the~     rate of new infections.~      Study Design :Multi-center, randomized, single blinded, controlled study. Study Population:~     newly-admitted, adult mechanically ventilated ICU patients.~   "
159402|NCT01479660|"~     Intestinal inflammation seen in inflammatory bowel disease (IBD) results from an altered~     mucosal immune response to luminal bacterial antigens. Current research suggests that an~     inappropriate and persistent immune response against commensal intestinal bacterial flora~     plays a pivotal role in the pathogenesis of chronic Inflammatory Bowel Disease (IBD). It has~     been also proposed that the signs and symptoms of IBD may be mediated by the increased~     intestinal permeability secondary to low grade inflammation in the gut mucosa. Increased~     intestinal permeability results in further exposure of underlying intestinal mucosa to~     luminal bacteria and antigens perpetuating the intestinal inflammation. Thus restoring~     intestinal permeability rather than only reduction of mucosal inflammation would thus be a~     desirable endpoint in the restoration of mucosal integrity and would be the harbinger of~     better long term outcome. Many clinical trials have shown that probiotics may have beneficial~     effect on IBD patients. Probiotics are hypothesized to work by several mechanisms though they~     are not clearly established. The role of probiotics in improving intestinal permeability has~     not been evaluated. The probiotic VSL #3 is easily available, cheap, effective and safe~     alternative or substitute for the existing therapeutic agents will be evaluated in this study~     for their efficacy, tolerability, compliance in inducing clinical response in patients with~     Ulcerative colitis. This will be a double blind randomized placebo controlled study to~     determine the clinical efficacy of 12 weeks of oral probiotics (VSL#3) in patients with~     inflammatory bowel disease. The objectives of this study are to determine the efficacy of~     probiotics on clinical endoscopic and histological improvement, to find the improvement in~     faecal, serum and intestinal tissue inflammatory markers, improvement in intestinal~     permeability, improvement in Quality of life parameters.~   "
159403|NCT01479647|"~     The purpose of this study is to investigate the effect of food on the time course of~     PH-797804 concentration in the blood following dosing by oral immediate release tablet~     formulation.~   "
159404|NCT01479634|"~     A study of antiretroviral therapy (ART) initiation under a streamlined model of care in~     HIV-positive patients with CD4+ cell counts greater ≥ 250 cells/uL~   "
159405|NCT01479621|"~     This is a randomized, double-blind, placebo- and open-label active controlled,~     parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and~     older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary~     objective of this study is to evaluate the dose response, efficacy and safety of 4 different~     doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler)~     when administered twice daily.~   "
159498|NCT01478399|"~     Primary objective:~      To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose~     administered by subcutaneous injection to subjects with normal renal function and impaired~     renal function.~      Secondary objectives:~      To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a~     subcutaneous injection in adult subjects with normal renal function and impaired renal~     function.~   "
159406|NCT01479608|"~     Colorectal liver metastases (CLM) are currently considered an absolute contraindication for~     liver transplantation (Lt) although Lt for other primary and secondary liver malignancies~     show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed,~     but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then,~     several advances have been achieved and survival following Lt has improved by almost 30%.~     Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated.~      The investigators have previously included 21 patients in a pilot study. All patients had~     advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously~     reported outcome for this patient group and is comparable or better than survival following~     repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further~     improve the results.~      The investigators will conduct a randomized controlled trial to explore whether liver~     transplantation in selected patients with liver metastases from CRC can obtain significant~     life extension and better health related quality of life compared to patients receiving~     surgical resection.~      The investigators will also explore if patient selection according to nomo-grams for outcome~     of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50%~     or even cure from the disease.~   "
159407|NCT01479595|"~     This study is designed to investigate the efficacy and safety of QBX258 in subjects with~     moderate to severe asthma.~   "
159408|NCT01479582|"~     Background:~      - Cord blood banks have been set up to collect and store umbilical cord blood for~     transplants. These transplants are used to treat different types of cancer. In October 2011,~     the Food and Drug Administration (FDA) began considering cord blood as a biological drug.~     Most of the cord blood units currently available in cord blood banks in the United States and~     other countries were collected before the FDA set these new standards. The units meet~     standards set by the National Marrow Donor Program (NMDP), but they were not collected,~     tested, or stored exactly according to FDA standards. As a result, the new guidelines state~     that they may only be used for transplant if the transplant is done as part of a study.~     Researchers have set up a study to provide these cord blood units to recipients and to study~     the effects of their use.~      Objectives:~        -  To provide access to cord blood units for recipients whose best choice for a unit meets~          NMDP but not FDA standards.~        -  To study the effects of these cord blood transplants.~      Eligibility:~      - Individuals who need to have a cord blood transplant to treat certain types of cancer.~      Design:~        -  Participants will be screened with a physical exam, medical history. They will also have~          blood tests and imaging studies.~        -  Participants will have the cord blood transplant and allow their medical data to be~          collected by the study researchers.~   "
159409|NCT01479569|"~     Background:~      - Pericardiocentesis uses a needle and small tube to drain fluid from space around the heart.~     The most common reason to perform this procedure is that the fluid is interfering with heart~     function. This procedure is usually guided by X-rays. However, researchers want to try the~     procedure using magnetic resonance imaging (MRI) instead of X-rays. MRI guidance may be more~     precise than X-rays, which can make the procedure easier and more effective.~      Objectives:~      - To test whether MRI guidance can improve pericardiocentesis.~      Eligibility:~      - Individuals at least 18 years of age who need to have pericardiocentesis.~      Design:~        -  Participants will have a physical exam before the procedure. Blood samples will be~          taken.~        -  The pericardiocentesis will be performed using MRI guidance. The procedure may take up~          to 2 hours.~        -  If for some reason the MRI guidance is not successful, participants will have the~          regular X-ray procedure. The MRI system will be used to take high-quality pictures~          afterward to check the results....~   "
159410|NCT01479556|"~     This study is a phase IV clinical trial with the objective of evaluating whether pain relief~     associated with pregabalin for at-level non-evoked and evoked neuropathic pain is more~     efficient during the early rather than late subacute phase of spinal cord injury.~   "
159411|NCT01479543|"~     The present report describes the design of a clinical trial performed on healthy adult~     individuals to check whether the daily intake of the new Hero strains contribute to~     intestinal colonization, under safe and tolerable conditions, with a positive contribution to~     health and wellbeing of healthy individuals.~      Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036),~     increases intestinal microbiota in healthy adults, being safe and well tolerated. The regular~     intake has positive effects on the gastrointestinal and immune system.~   "
159412|NCT01479530|"~     The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety~     of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese~     patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of~     idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in~     patients with end of dose fluctuations.~   "
159413|NCT01479517|"~     The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for~     unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary~     teeth for dental procedures.~   "
159414|NCT01479504|"~     This study is a multicenter trial.The primary objective is to estimate short-term efficacy~     and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant~     chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to~     the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent~     chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma.~      Secondary objectives are to evaluate the overall survival, the distant metastases free~     survival, and disease free survival of patients with locoregionally advanced nasopharyngeal~     carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the~     regimens.~   "
159415|NCT01479491|"~     This study aims to analyse baseline data on IS in order to monitor the possibility of~     increased risk of IS in children aged <12 months after introduction of the Rotarix~     vaccination in Japan.~   "
159416|NCT01479478|"~     The investigators wish to determine if oral probiotic supplementation during the second half~     of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational~     age, thereby decreasing need for maternal antibiotic administration at time of labor. The~     importance of this study is that it may offer a safer alternative to antibiotic treatment of~     group B Streptococcus (GBS) colonized pregnant women.~   "
159423|NCT01479387|"~     This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in~     Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess~     biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin~     is injected to the patient for the actual treatment. The objective of this study is to assess~     appropriateness and necessity of revision of the standardized criteria for image~     interpretation of In-111 Zevalin by comparing assessment by the investigator and the members~     of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be~     recruited.~   "
159424|NCT01479374|"~     The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic~     solution for the treatment of ocular itching associated with allergic conjunctivitis using~     the Conjunctival Allergen Challenge (CAC) model.~   "
159425|NCT01479361|"~     Background:~      - People who are infected with the human immunodeficiency virus (HIV) are at risk of getting~     certain diseases. Two of these diseases are a type of pneumonia known as PCP and a brain~     infection called toxoplasmosis. Most people with HIV take antiretroviral (ARV) drugs to treat~     HIV and lower the risk of infections. However, some ARV drugs may make other drugs used to~     treat PCP and toxoplasmosis less effective. Researchers want to test specific ARV drugs to~     see if they affect atovaquone, a drug used to treat PCP and toxoplasmosis.~      Objectives:~      - To see if ARV drugs atazanavir-ritonavir or efavirenz lower the blood levels of atovaquone.~      Eligibility:~        -  Individuals between 18 and 70 years of age who have HIV.~        -  Participants must be taking efavirenz or atazanavir-ritonavir, or not taking any ARV~          drugs.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  This study has a screening visit and five study visits. Two of the study visits will~          last about 12 hours; the other three visits will last about 1 hour each.~        -  Participants will receive either a low dose or high dose of atovaquone to take for 14~          days. They will record doses and any symptoms on a diary card at home.~        -  After 14 days, participants will have a 12-hour visit to provide blood samples. There~          will be a wash-out period with no doses for up to 6 weeks.~        -  After the wash-out period, participants will switch dose levels to either the high or~          low dose.~        -  After 14 days, participants will have a 12-hour visit to provide blood samples.~   "
159426|NCT01479348|"~     Background:~      - The drugs FdCyd (also called 5-fluoro-2'-deoxcytidine) and THU (also called~     tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how~     FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging~     studies to see how the drug reacts with the cancer. This study is not a treatment study. It~     is open only to people who are already on the FdCyd and THU cancer treatment study.~      Objectives:~      - To study how FdCyd affects advanced cancer cells.~      Eligibility:~      - Participants in National Cancer Institute study 09-C-0214.~      Design:~        -  Participants will have two imaging studies, one before starting FdCyd and THU treatment~          and one after starting treatment.~        -  Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The~          doses will be followed by two imaging study scans and frequent blood samples.~        -  This procedure will be repeated at a later date, during the FdCyd and THU treatment~          period.~        -  Treatment will not be provided as part of this study. This is an imaging study protocol~          only.~   "
159427|NCT01479322|"~     Context: Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset~     obesity and endocrine dysfunction that leads to cardiovascular disability and early death~     within the first 3 decades of life.~      Objectives: To assess the significance of risk factors for future disabilities, carotid~     artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic~     risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted~     controls.~   "
159428|NCT01479309|"~     The goal of this clinical research study is to expand the research following finding the~     highest tolerable dose of sodium stibogluconate combined with interferon alfa-2b in the~     treatment of patients with advanced cancer that has not responded to standard treatment or~     where there is no standard treatment for this type of cancer.~   "
159429|NCT01479296|"~     The purpose of this study is to evaluate the immune response to the Vaccine Research Center~     (VRC) rAd5 HIV vaccine when the vaccine components are administered in three different ways,~     in healthy, HIV-uninfected adults.~   "
159430|NCT01479283|"~     The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial is the first ever~     international multi-center randomized controlled trial in bone cancer surgery. In order to~     avoid amputation for bone cancer in the leg, complex limb-saving operations are performed.~     However, infections with devastating complications following surgery are common. Surgeons~     from across the world will randomize patients to receive either short- or long-duration~     antibiotic regimens after surgery with the goal of identifying the best regimen to reduce~     these infections.~   "
159431|NCT01479270|"~     The Transversus Abdominal Plane (TAP) block has been used with good success to decrease~     postoperative pain following laparatomy. If the TAP block provides any improvement in the~     quality of recovery following laparoscopic hysterectomy, it could decrease the need for~     postoperative narcotics and allow for more outpatient hysterectomy procedures.~   "
159432|NCT01479257|"~     The goal of this research study is to learn how cultural, environmental, and interpersonal~     experiences, as well as personal thoughts and feelings, influence cancer risk behaviors among~     Latino residents of Houston, Texas.~   "
159433|NCT01479244|"~     Purpose of this trial:~        1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine®~          (sargramostim, GM-CSF).~        2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control~          subjects.~   "
159434|NCT01479231|"~     The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in~     Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton~     Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of~     GERD on the location of esophageal eosinophilia.~   "
159435|NCT01479218|"~     The objective of the study is to investigate the safety, efficacy and clinical utility of the~     Occlutech PDA device for closure of patent ductus arteriosus of all types.~   "
159499|NCT01478386|"~     Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more~     effective in treating the symptoms of knee OA then treating with viscosupplementation alone~   "
159436|NCT01479205|"~     One aim of this study was to find out if the bronchial allergen provocation (BAP) is an~     appropriate method to appraise the efficacy of a specific immunotherapy (SIT). The~     investigators had one group of children receiving SIT and one group of patients who denied a~     SIT although they had an indication for it. Retrospectively the investigators analysed the~     data of the first BAP and blood parameters specific IgE-mite, total IgE before SIT (November~     2008 till February 2010). Prospectively The investigators analysed the lung parameters and~     allergic labor parameters that we got in the course of the second BAP. The investigators mean~     parameter was PD20FEV1-mite. Another aim of The investigators study was to find specific~     immunological differences between children who improved because of SIT and those who showed~     no improvement. Thus, The investigators compared the levels of total IgE, cumulative IgE-mite~     and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific~     IgG4-mite after SIT.~   "
159437|NCT01479192|"~     The purpose of this trial is to assess the effect of fenretinide (4-HPR), a vitamin A~     derivative, in reducing the incidence of breast cancer in healthy premenopausal women at~     increased familial/genetic risk for breast cancer~   "
159438|NCT01479179|"~     The goal of Phase 1 of this clinical research study is to test the safety and tolerability of~     AMG 479 when given with trastuzumab.~      The goal of Phase 2 of this clinical research study is to learn if the combination of AMG 479~     and trastuzumab can help to control breast cancer.~      AMG 479 is designed to block tumor cells from growing and spreading.~      Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking~     proteins inside the cancer cell.~   "
159439|NCT01479166|"~     In the planned study, 60 patients with mild cystic fibrosis (CF) with and without the~     involvement of small airways (small airway disease - SAD) are to be compared with a~     historical control group matched in age and gender. During the first study visit subjects are~     asked to perform a pulmonary function test (spirometry, body plethysmography with helium,~     determination of Trapped Air) and exhaled nitric oxide (eNO) and exhaled carbon monoxide~     (eCO) measurements will be done in exhaled air. In addition, a blood sample is drawn to~     describe inflammatory status. Sputum is induced as well. During the second study visit, a~     non-specific bronchial provocation test(methacholine PD20 FEV1) is performed.~      The aim of the study is to get a characterization of the bronchial and systemic inflammation~     (IL-1ß, IL-6, IL-8, IL-17, TNF-α, NFKB, and recognition structures like TLR2 and TLR4) in CF~     patients with and without the involvement of the small airways, which may point to new~     treatment strategies.~   "
159440|NCT01479153|"~     Central venous catheters are needed in the critical care setting to administer drugs. Three~     sites are available to gain vascular access: subclavian, internal jugular and femoral. Each~     site has complications, but there is no randomized controlled study which compared the 3~     sites.~      The investigators hypothesis is that subclavian catheterization reduces the risk of major~     complications compared to internal jugular or femoral.~   "
159441|NCT01479140|"~     Despite a relatively high prevalence of non-atherosclerotic coronary artery disease (NACAD)~     among young women, the majority of these abnormalities were misdiagnosed in this population,~     and thus treatments were not targeted adequately in this patient population. Furthermore, the~     short and long-term cardiovascular outcomes of young women with NACAD have not been~     evaluated. Given the importance of NACAD in young women, the challenges of diagnosis and~     subsequent treatment, and unknown outcomes with NACAD, we propose a prospective registry to~     further evaluate this population. We propose to evaluate young women (age < or equal to 55)~     presenting with myocardial infarction (MI) prospectively, to diagnose the etiology of MI~     differentiating atherosclerotic versus NACAD, to correlate the prevalence of FMD in other~     vascular territory, and to evaluate the long-term outcome of young women with NACAD in~     comparison to those with atherosclerotic CAD over a 5-year follow-up.~   "
159442|NCT01479127|"~     To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced~     Parkinson's disease (PD) patients with severe motor complications. The complications of~     medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be~     investigated.~   "
159443|NCT01479114|"~     The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on~     neutrophil production and CD11b expression.~   "
159444|NCT01479101|"~     The scope of this registry study is to measure chemosensitivity as defined by pCR (primary~     endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor~     diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant~     endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free~     survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by~     the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to~     possible novel expression profiles.~   "
159445|NCT01479088|"~     Twelve-month, multicenter, intra-subject controlled (retrospective-prospective), open-label,~     active-treatment study to evaluate the dose-response and pharmacokinetics (PK) of cinacalcet~     HCl for the treatment of Secondary Hyperparathyroidism (SHPT) in paediatric subjects with~     chronic kidney disease (CKD) on dialysis, followed by 12-month study extension.~   "
159446|NCT01479075|"~     Insulin has a direct effect on the energy metabolism of the brain under basal conditions and~     has an effect on the hepatic glucose production, lipid metabolism and the secretion of~     various hormone. The effect of intranasal insulin on peripheral metabolism in humans~     supposedly is mediated by the vagus nerve.~      The purpose of this study is to determine whether central insulin influences the human~     peripheral insulin sensitivity of liver and muscle and whether vagus nerve stimulation can~     mimick this effect.~   "
159447|NCT01479062|"~     The trial will test whether the Alive multi-channel delivery health behavior program can~     positively affect weight and glucose level in pre-diabetics.~   "
159500|NCT01478373|"~     The purpose of this study is to evaluate the efficacy and safety of Dovitinib in patients~     with gastrointestinal stromal tumors refractory and/or intolerant to Imatinib~   "
159501|NCT01478360|"~     This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial~     asthma that is poorly controlled with the current standard of care.~   "
159558|NCT01477619|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study~     will provide an assessment of the effect, if any, of age and body size on the safety and~     tolerability profile and the pharmacokinetics of tasimelteon.~   "
159448|NCT01479049|"~     The investigators previously investigated the cardioprotective effect of an~     adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric~     cardiac surgery, which was associated with better myocardial protective effects when compared~     with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked~     back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and~     severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that~     a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest~     the heart and have better myocardial protective effects compared with conventional~     hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution~     and systemic hypotension.~   "
159449|NCT01479036|"~     This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and~     epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer~     patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy~     to chemotherapy could further benefit breast cancer patients.~   "
159450|NCT01479023|"~     2.1 Primary Objectives~        1. To measure the human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid~          tumors (Cohort 1 only)~        2. To calculate HER3 receptor occupancy (via quantification of the tumor-localized PET~          signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled~          U3-1287 in subjects with advanced solid tumors (Cohorts 2 through 5))~        3. To determine the safety and tolerability of 64Cu-DOTA-U3-1287 (all cohorts)~      2.2 Secondary Objectives~        1. To determine the relationship between U3-1287 serum concentration and HER3 receptor~          occupancy (as measured by PET/CT) in subjects with advanced solid tumors~        2. To measure the tumor response rate as defined by Response Evaluation Criteria in Solid~          Tumors (RECIST 1.1) in subjects with advanced solid tumors treated with U3-1287 (Part 2~          only)~        3. To characterize the PK exposure of U3 1287 when administered intravenously to patients~          with advanced solid malignancies.~        4. To measure the rate of anti-U3-1287 human antibody development in subjects with advanced~          solid tumors treated with U3 1287 monotherapy~      2.3 Exploratory Objectives~        1. To assess tumor volume changes after U3-1287 treatment by CT or magnetic resonance~          imaging (MRI) (Part 2 only)~        2. To assess blood, body fluid/tissue, and tumor specimens for potential biomarkers (e.g.,~          proteins and transcripts) that predict response to U3-1287~        3. To obtain tumor samples for DNA extraction for analysis of potential predictors of~          response to U3-1287 and any related genes as suggested by emerging data~   "
159451|NCT01479010|"~     This is an open-label non-randomized, pilot study to evaluate the effect of Interleukin-1~     blockade on exercise capacity in patients with pulmonary hypertension. Subjects will undergo~     cardiopulmonary exercise testing at baseline, and after 4 weeks treatment with Anakinra~     (recombinant human Interleukin-1 receptor antagonist.~   "
159452|NCT01478997|"~     This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving~     symptoms of Moderate Osteoarthritis of the Knee.~   "
159453|NCT01478984|"~     Patients with NSTEMI and multivessel disease will be scheduled to undergo early invasive~     strategy (PCI within 72 hours) of de novo native coronary artery lesions were considered for~     recruitment into the study. Inclusion criteria are the following: diagnosis of NSTEMI~     according to current guidelines presenting with multivessel disease. We will exclude patients~     with cardiogenic shock at presentation (systolic blood pressure <90 mmHg despite drug~     therapy), left main coronary disease (>50% diameter stenosis), previous coronary artery~     bypass grafting (CABG) surgery, patients with Syntax Score >32 and candidated to by-pass~     surgery (10), severe valvular heart disease and unsuccessful procedures. Procedure success~     was defined as the achievement of an angiographic residual stenosis of less than 30% and a~     thrombolysis in myocardial infarction (TIMI) flow grade III after PCI.~      Patients randomized to One-Stage group were completely revascularizated in one time PCI,~     whereas patients randomized to Multi-Staged group were completely revascularizated in more~     time PCI, during the same hospitalization. Patients received a clopidogrel loading dose of~     600 mg before the PCI (for loading dose administered more than 6 h prior to procedure).~     Post-procedural antiplatelet regimen consisted of aspirin at 100 mg/day indefinitely and~     clopidogrel 75 mg/day for at least one month.~   "
159454|NCT01478971|"~     The purpose of this study is to understand the effects of a dialysis center switching its~     dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and~     other parameters.~   "
159455|NCT01478958|"~     It is well established that diet plays an important role in both the development and~     progression of heart disease. Different types of dietary fat have varying effects on heart~     disease risk factors. The elasticity of an individual's blood vessels is strongly associated~     with heart disease risk and recent evidence suggests that dietary manipulation may influence~     elasticity of the blood vessels with dietary fat (including saturated, monounsaturated and~     polyunsaturated fatty acids) as a potentially important modulator. Substantial evidence~     exists on the effects of monounsaturated fats (type of fatty acids mainly found in olive and~     rapeseed oil), n-6 polyunsaturated fats (type of polyunsaturated fatty acids found in~     vegetable oils) and saturated fat (found mainly in animal derived products) on lipid levels.~     However, the influence of these dietary fats on the elasticity of blood vessels remains~     unclear.The main purpose of the DIVAS study is to determine the effects of the substitution~     of saturated fats with either n-6 polyunsaturated or monounsaturated fats on blood vessel~     elasticity and to determine the effects of these different dietary fats on other risk factors~     for heart disease including lipoproteins and inflammatory biomarkers.~   "
159502|NCT01478347|"~     The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population~     potentially at risk for meningococcal disease (e.g. lab workers).~      In the second part of the study additional blood samples of high responding vaccinated~     subjects will be collected for the purpose of generating a control serum panel for the human~     serum bactericidal assay (hSBA) tests.~   "
159503|NCT01478334|"~     The primary aim of the study is to investigate if 10 weeks of high intensity interval~     training improve inflammatory status in patients with rheumatoid arthritis.~   "
159523|NCT01478074|"~     This is a single-center open-label phase I clinical trial of delivering haploidentical~     natural killer (NK) cells matured ex vivo with ALT-801 followed by intravenous infusions of~     ALT-801 in patients with relapsed/refractory Acute Myeloid Leukemia (AML). The study will be~     conducted at M.D. Anderson Cancer Center (MDACC) and MDACC Children's Cancer Hospital in~     Houston, Texas.~   "
159456|NCT01478945|"~     This study is a small pilot randomised controlled trial (RCT) comparing hand-held NB-UVB~     light devices with placebo devices. These devices will be used by the participants to treat~     their vitiligo at home for a period of four months. The main purpose of the trial is to~     provide feasibility data that can be used to inform the design of a future multi-centre RCT~     of these devices. Two hand-held UVB devices with similar manual operating system are being~     tested during this pilot study. This trial will help the investigators to establish which~     device is likely to be best for the main trial.~      Participants will be approached in a variety of ways (through secondary care, primary care~     and through direct advertising). Potential participants who contact the co-ordinating centre~     expressing an interest in the trial will be given more information about the trial, checked~     for preliminary eligibility, and sent an appointment for a screening visit at the closest~     recruiting hospital (Nottingham or Leicester).~      This screening visit will be conducted by a research nurse, but a dermatologist will also be~     present in order to confirm the diagnosis of vitiligo and to confirm the participant's~     suitability for UVB treatment at home. If eligible and willing to take part in the trial,~     participants will provide written informed consent and baseline data will be collected. In~     order to define the starting dose to be used when treating the vitiligo, a minimum erythema~     dose (MED) test will be conducted.~      An educational session will be provided by the research nurse outlining how to use the~     devices, how to assess side-effects of the treatment and how to complete the treatment diary.~     It is anticipated that the screening visit and educational session will take place on the~     same day and may take up to 1.5 hours.~      On the following day, a brief visit to the hospital will be required in order to examine the~     skin and read the MED results (if more convenient, the educational session may be delivered~     at this time). Once this has been done, participants will be given the devices to use at home~     - treatment is applied 3 times per week on alternate days. They will be followed up by~     telephone at week 1, week 2 and week 12 - in order to provide support and to monitor~     side-effects. Participants will be asked to keep a treatment diary that records when the~     treatment has been used and records side-effects experienced. Emergency contact details will~     be provided in case of urgent medical need.~      Participants will continue with treatment at home for the 16-week trial period. Two further~     hospital visits will take place in order to record outcome data~   "
159457|NCT01478932|"~     The purpose of this study is to provide information on how the practicing of diaphragmatic~     breathing retraining (DBR) for 8-week at home may improve the health outcomes and encourage~     heart failure patients to engage in health-promoting activities by successfully controlling~     their shortness of breath (dyspnea).~   "
159458|NCT01478919|"~     Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer.~     Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after~     conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue.~     Therefore, endoscopic follow-up and treatment are necessary. To decrease its occurrence, the~     risk factors of LRN shoudl be identified. Thereafter, in high-risk patients, other modalities~     of initial treatment including Endoscopic Submucosal Dissection (ESD) and surgical treatment,~     could be considered. The purpose of this prospective study is to identify risk factors~     associated with the presence of LRN after CER of LSTs.~   "
159459|NCT01478906|"~     The current study is designed to investigate the difference of plasma orexin A levels between~     elderly and young patients at emergence from sevoflurane-fentanyl anesthesia who will undergo~     elective lumbar surgery.~   "
159460|NCT01478893|"~     The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068.~     Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and~     smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be~     evaluated.~   "
159461|NCT01478880|"~     First clinical studies indicate an effect of repetitive transcranial magnetic~     stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size,~     optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled~     clinical trial we test the efficacy and safety of bilateral continuous theta burst~     stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment~     will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be~     treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and~     T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil~     tilted 45°). During weeks 4-6, all subjects receive real cTBS.~   "
159462|NCT01478867|"~     The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by~     assessment of gliadin 33-mer equivalent epitopes in feces.~   "
159463|NCT01478854|"~     The long term goal of this research is to establish whether NPC sparing RT techniques improve~     neurocognitive outcomes compared to conventional RT for brain tumors. If the proposed study~     demonstrates that NPC sparing RT is not associated with increased LR in the spared regions of~     the brain compared to conventional RT, it will ideally serve as the foundation for a future~     multi-institutional randomized controlled trial comparing neurocognitive outcomes in patients~     treated with NPC-sparing RT versus conventional radiation therapy.~   "
159464|NCT01478841|"~     Diet and nutrition play an essential role in the development and the clinical expression of~     the most common health problems. Overeating and obesity induce oxidative stress, which has~     been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes~     (T2D) and associated cardiovascular complications. The main objective of the proposed~     research is to evaluate the beneficial effects of polyphenolic compounds derived from red~     grape marc extracts on the cascade of events leading from overeating to oxidative stress and~     insulin resistance. For that, we will study free radicals production, inflammatory markers,~     adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in~     healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D~     patients with associated overweight). These volunteers will be randomized between a placebo~     and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of~     polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.~   "
159465|NCT01478828|"~     To determine the dose of continuous daily oral lovastatin needed to achieve MYC [v-myc~     myelocytomatosis viral oncogene homolog (avian)] down-regulation in prostatectomy specimens~     in intermediate-/high-risk localized prostate cancer patients.~   "
159504|NCT01478321|"~     This phase II trial studies how well giving hypofractionated radiation therapy together with~     temozolomide and bevacizumab works in treating patients with high-grade glioblastoma~     multiforme or anaplastic glioma. Specialized radiation therapy, such as hypofractionated~     radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     hypofractionated radiation therapy together with temozolomide and bevacizumab may kill more~     tumor cells.~   "
159466|NCT01478815|"~     Contingency management is efficacious for treating cocaine abuse, but contingency management~     interventions have rarely been applied to patients with severe and persistent mental health~     problems. This pilot project will estimate effect sizes of contingency management for~     reducing cocaine use in patients receiving psychiatric care at a large community based mental~     health program. In total, 30 cocaine abusing patients will be randomized to one of two 8-week~     treatment conditions: standard care or standard care with contingency management. Patients in~     both conditions will provide breath and urine samples for toxicology testing twice per week.~     In the contingency management condition, patients will receive the opportunity to win prizes~     for submitting cocaine negative urine samples. The investigators expect that patients~     receiving contingency management will evidence reductions in cocaine use and may show~     improvements in psychiatric symptoms and psychosocial functioning relative to patients in~     standard care. Effect size estimates obtained from this study will be used to guide larger~     scale and longer duration evaluations of contingency management for dually diagnosed~     patients.~   "
159467|NCT01478802|"~     Based on recent two-center results (Eur Respir J. 2011 Sep 1. [Epub ahead of print] PMID:~     21885390) we hypothesized that intermittent High-frequency oscillation (HFO) combined with~     Recruitment Maneuvers (RMs) may beneficially affect the pathophysiology and survival of~     patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).~      Design: Randomized Controlled Trial. Intervention: Briefly, the HFO-RMs strategy of the~     intervention (HFO-RMs) group will comprise RMs (3/day) and an initial HFO session of 96 hours~     (HFO session can be interrupted before the 96-hour time point only if PaO2/FiO2 rises to >200~     mmHg for >12 hours), followed by return to lung protective conventional mechanical~     ventilation (CMV) according to pre-specified oxygenation criteria. Within days 1-10~     postrandomization, patients will be returned to HFO upon recurrence of their~     moderate-to-severe oxygenation disturbance. Patients of the control (CMV) group will receive~     lung protective CMV.~   "
159468|NCT01478789|"~     The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering~     of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol~     esters (PS-ester), consumed within dairy products.~   "
159469|NCT01478776|"~     The aim of this study is the comparison between the effects of supplementation with omega-3~     or placebo for 10 weeks in type 2 diabetics~   "
159470|NCT01478763|"~     Analysis of vitreous proteins in patients undergoing pars plana vitrectomy for proliferative~     diabetic retinopathy~   "
159471|NCT01478750|"~     Interaction of fat with the mouth, stomach and intestine will trigger physiological responses~     that will impact on the digestion, gut transit time and absorption of fat. These responses~     will also influence and contribute to regulation of food intake and satiety. No systematic~     research on understanding how the physiological-chemical properties of food affect the~     digestion and absorption of lipids has been carried out previously. Studies have shown that~     the release of free fatty acids triggers the fat-related responses. The investigators~     hypothesize that the release of fatty acids depends on the colloidal state of the fat, which~     changes progressively due to the pH changes and enzyme activities in the mouth, stomach and~     intestine.~   "
159472|NCT01478737|"~     To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage~     after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy~     (PDRP).~   "
159473|NCT01478724|"~     Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and~     microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility~     and susceptibility to fracture. Osteoporosis is a serious public health problem that is~     responsible for approximately 3 million women with osteoporosis in France, with approximately~     150,000 cases per year occurring in vertebral fractures, of which only one third would be~     diagnosed and 50,000 hip fractures (causing death in 20% of cases). The frequency of the~     disease increases with age, particularly among women: 10% among women aged 60 years and 20%~     among women aged 65 and 40% among women aged 75. At menopause, oestrogen deficiency causes~     alterations of the immune system, decreased bone formation, microarchitectural deterioration~     and a decrease in bone mass. Various factors may contribute to this decrease in bone density~     such as diet, lifestyle, or the genetic background.~      According to prospective studies, an overexpression of 135% of hip fractures is expected at~     European level in 50 years. Therefore, it is interesting to develop new prevention approaches~     aimed at maintaining the healthy aging population. Nutritional researches can consider~     setting up a real prevention.~      Studies suggest that specific milk protein fraction contain factors able to promote bone~     formation, inhibit bone resorption in vitro. In animal model, they showed that the specific~     fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption.~     Furthermore, in human volunteers, a supplementation with the specific milk protein fraction~     maintains balanced bone remodelling and increase bone mineral density. For example, in~     healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in~     the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p<0.05).~      The objective of this study is to assess the efficacy of daily consumption of the milk~     proteins fraction on bone mineral density improvement in healthy postmenopausal women.~   "
159474|NCT01478711|"~     This study will use a rules-based expert system embedded in an electronic health record (EHR)~     to extract, interpret, and present salient facts and recommendations related to the~     healthcare of premature infants.~   "
159475|NCT01478698|"~     Hypothesis:~      Intraperitoneal tPA and DNase is well tolerated at a number of different doses. Different~     doses of tPA and DNase will have a dose-related effect on inflammatory markers (CRP and~     intraperitoneal white cell count).~      Aims:~        1. To examine the tolerability of different doses of intraperitoneal tPA and DNase compared~          to standard treatment.~        2. To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the~          addition of intraperitoneal tPA and DNase to usual therapy.~   "
159476|NCT01478685|"~     The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose~     (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in~     combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in~     subjects with relapsed or refractory solid tumors.~   "
159477|NCT01478672|"~     The purpose of this study is to evaluate whether the introduction of large-scale personalized~     and technology supported telemonitoring and health coaching interventions produces benefits~     in terms of health related quality of life, health status and empowerment of patients with a~     cardiovascular disease. In addition, the trials evaluate the economical and organizational~     impact of the new services and examine their acceptability by patients and health~     professionals.~   "
159505|NCT01478308|"~     This study is being conducted to determine the effectiveness of standard 3 weekly treatments~     using docetaxel and prednisone with metformin in patients with castration-resistant~     metastatic prostate cancer.~      It is also being conducted to determine the levels of toxicity of metformin when added to~     every 3 weekly docetaxel treatments in patients with endocrine resistent, metastatic prostate~     cancer.~   "
159478|NCT01478659|"~     The proposed study will be a randomized, double-blind, parallel-arm study. Participants will~     incorporate snack foods (bar/yogurt) containing 16 grams of fiber (fructooligosaccharide) or~     similar snack foods without the added fiber into their usual diets. The study period will~     include a 2-week pre-baseline assessment period and an 8-week treatment period. During the~     2-week pre-baseline period no study foods will be consumed however dietary intake will be~     assessed using a 24-hour online diet recall program. The first week of the 8-week treatment~     will serve as an acclimation period where only one serving of the study foods will be given~     (8 grams of fiber) per day. Participants will receive two servings (16 grams of fiber) per~     day for weeks 2 through 8 of the treatment period and 24-hour online diet recalls will be~     completed during weeks 4, 6 and 8.~      Hypothesis:~      Adults aged 18 to 50 years consuming their usual diet modified by incorporating yogurt and~     snack bars containing 16 grams of chicory root fiber (Frutalose®) will decrease their usual~     dietary intake to a greater extent compared to participants who receive similar snack foods~     without the added fiber.~   "
159479|NCT01478646|"~     The purpose of this study is to determine whether different types of breathing therapies in~     patients with COPD III-IV decrease dyspnea and increase activity.~   "
159480|NCT01478633|"~     The purpose of this study is to evaluate the efficacy and safety of galantamine in patients~     who failed to benefit from donepezil (patients switching from donepezil). In clinical~     practice, it is expected that galantamine will be used in patients switching from donepezil~     due to the insufficient efficacy of donepezil.~   "
159481|NCT01478620|"~     The objective of the study is to assess safety and impact of a non-antibiotic therapy~     approach with Canephron® N in the management strategy of uncomplicated lower urinary tract~     infections (UTIs).~   "
159482|NCT01478607|"~     The purpose of the study is to assess the safety of repeated applications of QUTENZA in~     reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.~   "
159483|NCT01478594|"~     The objective of this study is to compare the progression free survival (PFS), overall~     survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of~     response (DoR), quality of life, safety and tolerability of tivozanib in combination with~     mFOLFOX6 and bevacizumab in combination with mFOLFOX6.~   "
159484|NCT01478581|"~     The primary objective of this study is to determine the efficacy of PCI-32765, both as a~     single agent and in combination with dexamethasone, in subjects with relapsed or relapsed and~     refractory Multiple Myeloma (MM)~   "
159485|NCT01478568|"~     The study aims to evaluate if blood levels of desipramine change whilst being dosed at the~     same time with daily mirabegron.~   "
159486|NCT01478555|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical~     administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic~     solution) compared to Vehicle and DuraSite alone.~   "
159487|NCT01478542|"~     The purpose of this study is to improve the outcome of elderly patients with CD20+ Aggressive~     B-Cell Lymphoma and to reduce the toxicity of standard used Immuno-Chemotherapy by using an~     optimised schedule of the monoclonal antibody Rituximab, substituting conventional by~     Liposomal Vincristine and by a PET-guided reduction of therapy in Combination with Vitamin D~     Substitution.~   "
159488|NCT01478529|"~     A study to evaluate how much of the active compound of mirabegron comes into the blood~     circulation when given as a controlled-release pill as compared to given intravenously.~   "
159489|NCT01478516|"~     The purpose of this study is to evaluate in a prospective study the efficacy of intravitreal~     autologous plasmin enzyme in macular edema and to analyze the fibrinolytic system in vitreous~     body.~   "
159490|NCT01478503|"~     The study aimed to compare age and gender differences for increasing doses of mirabegron when~     given to healthy young and elderly males and healthy young and elderly females.~   "
159491|NCT01478490|"~     The study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy~     poor or extensive metabolizers for CYP2D6 and to evaluate if blood levels of metoprolol~     change whilst being dosed at the same time with daily miragebron.~   "
159492|NCT01478477|"~     This randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in~     patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole.~     Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients~     receiving hormone therapy for breast cancer.~   "
159493|NCT01478464|"~     Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical~     exercise. Therapists often provide manual massage with the hands to acutely relief the~     soreness. Alternatives to manual hand massage can be useful for therapists. Here the~     investigators examine the acute effect of a massage roller on DOMS in the hamstring muscles~   "
159494|NCT01478451|"~     Many people experience pain, tenderness and soreness of joint and muscles, both in sport and~     working life. Pain killers can provide acute relief of pain, but may not be a feasible~     solution for all people. Here the investigators examine the acute effect of massage and~     exercise on induced muscle tenderness (delayed onset muscular soreness).~   "
159495|NCT01478438|"~     This study will determine the rate of complete tumor ablation of small breast cancers (≤~     20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and~     specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post ILT~     ablation as correlated to histopathology from the post-ablation excision.~   "
159496|NCT01478425|"~     Study design: Randomized, controlled, double-blind, parallel, multicentre multinational~     clinical trial, to show superiority of an active therapy as compared to a control therapy on~     intermittent or persistent Allergic Rhinitis.~      Primary objective:~        1. To show that a topical microemulsion is superior to a sterilized saline solution to~          prevent deterioration in the health related quality of life, in patients with~          intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree~          or grass pollen.~           Secondary objectives~        2. To explore the effect of a topical microemulsion, as compared to a sterilized saline~          solution, for the prevention of nasal and ocular symptoms in patients with intermittent~          or persistent allergic rhinitis due to sensitization to birch, olive tree or grass~          pollen.~        3. To explore the effect of a topical microemulsion, as compared to a sterilized saline~          solution, in the utilization of symptomatic medications, in patients with intermittent~          or persistent allergic rhinitis due to sensitization to birch, olive tree or grass~          pollen.~        4. To assess the patient's satisfaction with a topical microemulsion treatment, as compared~          to a sterilized saline solution, in patients with intermittent or persistent allergic~          rhinitis due to sensitization to birch, olive tree or grass pollen.~        5. To assess the safety of a topical microemulsion, as compared to a sterilized saline~          solution, administered to patients with intermittent or persistent allergic rhinitis due~          to sensitization to birch, olive tree or grass pollen.~      This is a clinical investigation study of a Class 1 medical device product. This is a~     prospective study of an active medical device versus a control medical device.~      It was considered feasible to recruit 10 patients patients per center, and therefore the~     study should be conducted in 10 centers. To get treatment balance within each center, a total~     of 100 patients should be recruited.~   "
162739|NCT01435720|"~     The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or~     refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by~     intravenous infusion at various doses.~   "
159507|NCT01478282|"~     The main goal of this study is to improve safety and efficiency of clinical practice with the~     new generation of oral anticoagulants.~        1. To determine the effect of new oral anticoagulants (dabigatran and rivaroxaban) on~          platelets and coagulation mechanisms under flow conditions.~        2. To evaluate the ability of the concentrates containing coagulation factors (PCCs and~          FVIIa) to reverse the effects induced by the new anticoagulants.~      These studies will be carried out ex vivo in blood samples obtained from healthy volunteers~     undergoing oral anticoagulant therapy at doses of proven efficacy and safety used in previous~     clinical trials.~   "
159508|NCT01478269|"~     This study is a retrospective analysis of an homogeneous population of patients with~     aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to~     reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups~     with a clinical and therapeutical relevance.~   "
159509|NCT01478256|"~     This study looks at the improvements in signs and symptoms in patients with inflammation of~     the lids, blepharitis, using two different FDA approved topical antibiotic agents,~     Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients for~     microbiologic evidence of improvement.~   "
159510|NCT01478243|"~     Despite their benign nature, keloids may constitute a severe aesthetic, and in some cases,~     functional problem which translates to various repercussions on person's quality of life,~     including much stress and insecurities.~      Keloids are mostly observed between the ages of 10 and 30. Although keloid is a common~     condition and the investigators can make assumptions about those living with keloids, the~     investigators do not know the actual impact of the illness on the overall performance of~     patients' and how this disease, day to day, is impacting their lives. The investigators are~     conducting this study, aimed to investigate the psychosocial impact of keloid on daily life.~     Information is collected anonymously. You must be 18 years of age or older to take this~     survey. Parents can respond on behalf of their children who are not 18 years of age yet. The~     online survey will take 20-30 minutes to complete.~   "
159511|NCT01478230|"~     Subjects will be screened within 28 days before the first study treatment to confirm that~     they meet the requirements to participate in the trial. They will return to the site for two~     treatment visits, at least 12 hours each, and at least one day in between visits. At each~     visit treatment N1/3-I5 or Nicotine Inhaler 10 mg will be administered every hour for 11~     hours. The investigator (or an appropriate delegate at the investigator site) will obtain~     informed consent from each subject. Blood samples will be drawn on a special schedule. The~     total predicted amount of blood sampled from each subject is 174 mL over the whole study.~     Subjects will be required to follow specific smoking and dietary restrictions and rate their~     urges to smoke, general liking of the product, and how easy the product is to use.~   "
159512|NCT01478217|"~     The purpose of this study is to compare lung recruitment in acute lung injury (ALI)/acute~     respiratory distress syndrome (ARDS) based on lower inflection point with transthoracic~     ultrasonographic assessment of lung recruitment.~   "
159513|NCT01478204|"~     The purpose of this study is to evaluate sleep quality in patients with mild to moderate~     Alzheimer's disease treated with anticholinesterase drugs in clinical practice.~   "
159514|NCT01478191|"~     This is a retrospective analysis of a homogeneous cohort of patients with relapsed/refractory~     HL that received IGEV scheme as induction therapy to HDCT and AHSCT for reassess the most~     common prognostic factors and try to identify a prognostic score with clinical and~     therapeutic relevance by using 6 clinical tools:~        1. B symptoms(yes/no)~        2. relapse in previously irradiated areas(yes/no)~        3. Ann Arbor Stage (III/IV vs I/II)~        4. disease status at accrual (refractory vs relapsed)~        5. Early relapse within 12 months of Complete Response (CR) versus late relapse after~          Complete Response (CR) lasting > l2 months,~        6. extranodal involvement (yes/no).~   "
159515|NCT01478178|"~     The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and~     the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma.~     Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be~     evaluated.~   "
159516|NCT01478165|"~     A total intravenous anesthesia (TIVA) is a useful anesthetic technique that reduces the~     incidence of postoperative nausea and vomiting (PONV).~      Investigator hypothesized the incidence of PONV can be further reduced when palonosetron is~     added to TIVA.~   "
159517|NCT01478152|"~     In this single center, dose finding, safety study the effect of inhaled Ectoin® inhalation~     solution will be investigated in subjects with mild bronchial asthma. This dose-finding study~     will estimate the minimum effective dose and will assess the safe dosage, in terms of the~     quantity given to patients. The results will be compared to baseline measurements. The~     results regarding Sputum measurements will be compared to measurements after placebo~     administration.~   "
159518|NCT01478139|"~     The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula~     Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.~   "
159519|NCT01478126|"~     The purpose of this study is to determine whether perioperative glutamine administration~     possess protective properties on internal organs (heart and gut) in patients with coronary~     atherosclerosis, operated under cardiopulmonary bypass.~   "
159520|NCT01478113|"~     This study aims to identify a novel enhancement strategy for residual symptoms of major~     depressive disorder (MDD) Dopamine (DA) has been viewed as a pleasure neurotransmitter for~     over 30 years. Yet recent data from animal and human studies suggest that dopamine has~     greater effects on wanting than on liking. Therefore, the investigators of this study~     have hypothesized that amphetamine/d-amphetamine (AMPH), a medication which increases~     dopamine transmission in the reward centers of the brain, may have a more powerful~     antidepressant effect in combination with well-being therapy (WBT), a specific type of~     cognitive-behavioral therapy, which helps individuals with depression to increase their~     contact with natural rewards and decrease reward-interfering thoughts.~      The investigators will test their hypothesis by randomizing 40 individuals with residual~     symptoms of depression, already taking an antidepressant that affects serotonin (e.g. Prozac,~     Paxil), to 8 weeks of treatment with either WBT in combination with AMPH, or WBT with pill~     placebo. The effectiveness of each treatment will be measured using a reliable scale, called~     the Hamilton Depression Rating Scale.~      The investigators have also hypothesized that people assigned to the stimulant/WBT group will~     have greater improvements in functioning, well-being, and positive affectivity than those the~     people assigned to the WBT/placebo group.~   "
159528|NCT01478009|"~     Upper respiratory tract infections are a major source of morbidity throughout the world.~     Extracts of Korean red ginseng have been found to have the potential to modulate both natural~     and acquired immune responses. The investigators sought to examine the efficacy of an extract~     of Korean red ginseng in preventing colds. Therefore, the efficacy and safety of Korean red~     ginseng will be investigated in healthy subjects during the influenza season.~   "
159529|NCT01477996|"~     This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge)~     for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for~     standard recommendation regarding the optimal needle size for IVT.~   "
159530|NCT01477983|"~     This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different~     pharmacological approaches to improve long-term outcome of catheter ablation for atrial~     fibrillation (AF). The study is composed of UNmasking Dormant Electrical Reconduction by~     Adenosine TriPhosphate (UNDER-ATP) Trial and Efficacy of Antiarrhythmic Drugs Short-Term Use~     after Catheter Ablation for Atrial Fibrillation (EAST-AF) Trial. Patients with paroxysmal or~     persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio before~     the procedure (UNDER-ATP Trial). Excluding those with severe procedural complications or~     substantial bradycardia identified first after ablation for persistent AF, patients will be~     randomized in a 1:1 ratio to antiarrhythmic-drug (AAD) or control group after the procedure~     (EAST-AF Trial).~   "
159531|NCT01477970|"~     The possibility to prevent the early ovarian hyperstimulation syndrome (OHSS) by doubling the~     daily dose of GnRH-antagonist in women stimulated with the antagonist protocol who are at~     risk for OHSS was evaluated. Thirty-eight women of a study group who underwent ovarian~     stimulation using the GnRH-antagonist protocol and might have had their cycle cancelled~     because of OHSS were compared to 76 women of a control group. All cases of the study group~     were IVF women presenting a rapid rise of E2 ≥ 3500 pg/ml on the 7th day of stimulation or~     later while the follicles (> 12mm) were > 15 in total and the biggest one was ≤ 16mm in~     diameter. By decreasing the rFSH dose to 100IU a day and adding an additional dose of~     GnRH-antagonist (0.25 twice a day), estradiol levels were lowered or reached a plateau before~     hCG was given. A marked decrease or plateau of estradiol levels was observed the day of~     oocyte retrieval while the pregnancy rate was not adversely affected when compared with an~     optimum ovarian response cycles. None of the women were cancelled or developed OHSS.~      In overresponding IVF cycles, doubling the usual GnRH-antagonist daily-dose during the~     ovarian stimulation, the estradiol rise could be blocked while a minimal follicular~     stimulation may continue without the risk of OHSS or adversely affect pregnancy rate.~   "
159532|NCT01477957|"~     The purpose of this study is:~        1. To explore to what extent insulin sensitivity, energy metabolism and ectopic lipid~          storage can be improved by bariatric surgery~        2. To explore to what extent hepatic and muscular disorders of energy metabolism occur in~          patients with obesity (degree 2-3)~        3. To explore whether the steato liver occurring in patients with obesity (degree 2-3) is~          associated with the degree of liver inflammation~   "
159533|NCT01477944|"~     To describe the new statins prescription pattern in Catalonia (getting their first~     prescription for any statin, or receiving a change in their statin treatment including~     switching, changing in doses or adding ezetimibe/fibrates) since September 2009.~   "
159534|NCT01477931|"~     The aims of this study are 1) to examine the clinical utility of bupropion hydrochloride~     extended release (Wellbutrin XL®) in patients with Major Depressive Disorder (MDD) with~     atypical features; 2) to evaluate the tolerability of bupropion hydrochloride extended~     release (Wellbutrin XL®) in patients with MDD with atypical features.~   "
159535|NCT01477918|"~     The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean~     patients with schizophrenia.~      Primary objective:~      • To investigate the prevalence of the MetS in Korean patients with schizophrenia~      Secondary objectives:~      • To compare the prevalence of the MetS among 3 groups according to antipsychotics: typical~     antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more~     antipsychotics group (polypharmacy)~   "
159536|NCT01477905|"~     The investigators attempted to determine an adequate priming volume for our infusion system,~     and investigated the extent of a possible delay of the drug effect, that would result from~     mechanical defects of the infusion system, with or without priming the infusion system, using~     direct gravimetrical measurements of virtual infusate amounts during target controlled~     infusion of 2 remifentanil diluents.~   "
159537|NCT01477892|"~     The purpose of this study is to evaluate safety and efficacy of continuous infusion of~     remifentanil in preterm infant with mechanical ventilator for control of procedural pain~     using two different dosage of remifentanil.~   "
159538|NCT01477879|"~     This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo~     applied every 3-4 hours to herpes lesions.~   "
159539|NCT01477866|"~     The main aim of the present study is to test the efficacy and safety of CITOGENEX~     administration in patients with colon-rectal cancer.~   "
159540|NCT01477853|"~     This two-phase study was to examine if 16 weeks of treatment with sitagliptin in combination~     with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol~     (LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively.~     Following a single-blind placebo run-in period, participants were to be randomized to one of~     three treatment arms (sitagliptin monotherapy, atorvastatin monotherapy, or sitagliptin plus~     atorvastatin) for 16 weeks (Phase A). During Phase B of the study (Weeks 16 through 54),~     participants were to receive either sitagliptin plus atorvastatin or glimepiride plus~     atorvastatin. The primary hypotheses were that after 16 weeks of treatment, sitagliptin in~     combination with atorvastatin reduces A1C from baseline more than atorvastatin alone, and~     that atorvastatin in combination with sitagliptin lowers LDL-C from baseline more than~     sitagliptin alone.~   "
159541|NCT01477840|"~     The purpose of this study is to determine whether the effect of sublingual misoprostol is~     better than infusion oxytocin in reduction of blood loss at cesarean deliveries.~   "
159542|NCT01477827|"~     The purpose of this study is to examine the amount of sunlight exposure and vitamin D status~     of adolescent schoolchildren in each season throughout the year.~   "
163103|NCT01430936|"~     This is planned as a feasibility study. The objective is to evaluate a specially designed~     patient adherence and monitoring software on standard mobile devices in remote monitoring of~     heart failure patients.~   "
159543|NCT01477814|"~     The goal of the study is to conduct a randomized clinical trial to test several office-based~     strategies for improving colon cancer screening among individuals who are regular patients at~     16 family practice physician offices in the state of Iowa. These offices are members of the~     Iowa Research Network (IRENE), a rural practice-based research network. The interventions to~     be tested are increasing in intensity from the usual care provided in the office, to~     physician chart reminders, mailed educational materials to patients, a fecal immunochemical~     test with postage-paid return envelope, and a telephone call designed to determine attitudes~     and barriers to screening, and to motivate subjects to get screened. Our main research~     questions are: 1)do attitudes toward CRC screening change after providing educational~     materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a~     telephone reminder, result in increased rates of CRC testing with the FIT?~   "
159544|NCT01477801|"~     The purpose of this study is to determine whether cholecalciferol supplementation in patients~     with chronic heart failure and low vitamin D levels improves:~        1. performance at six minutes walking test~        2. echocardiographic parameters~        3. neurohormonal imbalance~   "
159545|NCT01477788|"~     The objective of the study is to create a test that will discriminate between malignant and~     benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about~     800 women and at the end of the study the investigators will combine data from the woman's~     history, the sonographic characters of the mass and serum biological markers along with the~     woman's outcome (which means - whether the mass was malignant, benign, or disappeared or~     remained constant with no intervention).~   "
159546|NCT01477775|"~     A subset of patients recruited in the main MATRIX study will be randomized after intervention~     but before discharge to standard of care (the treating physician will decide which oral P2Y12~     inhibitor will be added on top of aspirin) versus a customized approach based on an algorithm~     which integrates phenotypic information, including but not limited to residual on-treatment~     platelet reactivity assessed via VerifyNow P2Y12 Assay.~   "
159547|NCT01477762|"~     Posttraumatic stress disorder (PTSD) occurs in some people after exposure to events that~     cause extreme fear or helplessness. The incidence of war zones worldwide and the prevalence~     of violence in large cities in the U.S., increases the likelihood that people will experience~     a traumatizing event in their lifetime. About 1 in 10 people who survive such events will~     develop PTSD, while most people will get better over time. This suggests that some people may~     have biological vulnerabilities that make it harder for them to recover. One of these~     biological risk factors may be related to how stress hormones work in people who get sick.~     Another is how people react to things that make them afraid or nervous, investigators have~     found that PTSD patients have higher than normal fear reactions. The part of the brain that~     reacts to fearful stimulation is linked to stress hormones; the purpose of this study is to~     examine how these systems interact. The study will suppress stress hormones (cortisol)~     production in one group of participants, while another will get a placebo. When their~     cortisol is suppressed, the participants will undergo a startle study to see if their fear~     responses are decreased. Investigators expect that people PTSD will show a normal fear~     response when their cortisol levels are reduced, similar to people without PTSD. This~     research can help discover new medicines for people with PTSD.~   "
159548|NCT01477749|"~     To demonstrate that sipuleucel-T can be successfully manufactured for subjects with~     metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.~   "
159549|NCT01477736|"~     The purpose of this study is to compare the effects of oral oxybutynin and intradetrusor~     injections of botulinum toxin type A on urodynamic parameters and quality of life in patients~     with neurogenic detrusor overactivity following spinal cord injury.~   "
159550|NCT01477723|"~     Study objectives are to verify the loss of lean mass during a hospital stay in a group of~     older patients; to evaluate the effects of consuming a high-calorie complete and balanced~     oral nutritional supplement; to collect post-discharge information.~   "
159551|NCT01477710|"~     This study will compare three methods of delivering mechanical ventilation using a test lung.~     Ventilation will be delivered using (1) a mask held in place by a caregiver, (2) a mask~     strapped to the model using a securing device, and (3) a supraglottic airway. Endpoints~     include respiratory rate and tidal volume.~   "
159552|NCT01477697|"~     This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in~     trauma patients. The main hypothesis is that such supplementation will reduce the presence of~     biomarkers of systemic inflammation, as compared to placebo~   "
159553|NCT01477684|"~     The purpose of this study is to perform a descriptive, content-based analysis on the~     different forms of documentation for in-flight medical emergencies that are currently~     provided in the emergency medical kits on board commercial airlines.~   "
159554|NCT01477671|"~     This is a descriptive prospective community-based seroprevalence study.~      Primary objective:~        -  To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against~          dengue in healthy 5 to 10 year-old children in India.~      Secondary objectives:~        -  To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the antibodies~          in positive (IgG) samples~        -  To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis in~          healthy 5 to 10 year-old children in India.~   "
159555|NCT01477658|"~     Recent studies have shown that chronic stimulation of the right ventricle can cause~     deleterious effects to cardiac function and synchronicity. The occurrence and consequences of~     this phenomenon in children and young patients with cardiac pacemaker due to advanced~     atrioventricular block (AVB) are still unknown.~      Thus, our aims is to assess the chronic effects of cardiac pacing in children and young~     patients with advanced AVB and its impact on clinical, functional and echocardiographic~     parameters.~   "
159556|NCT01477645|"~     The purpose of this study is to determine whether use of lead free ammunitions cause more~     respiratory problems than use of lead containing ammunitions.~   "
159557|NCT01477632|"~     This trial is conducted in Europe. The aim of this trial is to determine the extent of~     bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a~     marketed estradiol/norethisterone acetate (NETA) preparation.~   "
160252|NCT01468493|"~     The purpose of this study is to determine whether the improved responsiveness to treatment~     achieved by CsA in patients with steroid-resistant or steroid-dependent FSGS could be~     explained by CsA's inhibitory action on the circulating suPAR expression.~   "
159559|NCT01477606|"~     This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute~     Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.~      The primary efficacy object is to evaluate the impact of midostaurin given in combination~     with intensive induction, consolidation including allogeneic hematopoietic stem cell~     transplantation and single agent maintenance therapy on event-free survival (EFS) in adult~     patients with AML exhibiting a FLT3-ITD.~      Sample size: 440 patients~      The treatment duration of an individual patient is between 18 and 24 months. Duration of the~     study for an individual patient including treatment (induction, consolidation [chemotherapy~     or allogeneic SCT], maintenance and follow-up period: Maximum 8 years~   "
159560|NCT01477593|"~     Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide.~     Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed~     routinely in every male newborn. The benefits from it vastly outweigh the risks. Gradually,~     more and more Chinese male are willing to undergo it with themselves and their sons. But~     there are also some complications with circumcision, such as pain, edema, infection, and~     hemorrhage. Considering of that, physicians continually manage to improve their surgical~     methods and analgesic techniques.~      In the study of Peng, a disposable minimally invasive circumcision anastomosis device named~     Shenghuan (China Wuhu Snnda Medical Treatment Application Technology Co. Ltd.) (ShD) was~     introduced to be applied in circumcision. And they concluded that method was quicker, safer~     and less pain than the conventional techniques of incision. In present study, we carry out a~     randomized controlled trail, using a different method as Peng introduced with this device in~     children's circumcision (Yan's), compared with the method as Peng used and the conventional~     technique in our hospital, and then observe the outcomes.~   "
159561|NCT01477580|"~     This study will determine whether at least one formulation of an experimental dengue vaccine~     (V180) is safe and causes an immune response.~   "
159562|NCT01477567|"~     The main purpose of this study is to determine the safety of LY3009385 in healthy~     participants. The study drug is given as a single dose, by injections under the skin. Side~     effects will be documented. This study is approximately 28 days not including screening.~     Screening is required within 28 days prior to the start of the study.~   "
159563|NCT01477554|"~     Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching~     the internationally established Millennium Development Milestones (MDM) is still a distant~     goal. A fundamental part of reducing maternal and infant mortality is ensuring an adequate~     and timely response to obstetric emergencies. PRONTO2: Obstetric and Neonatal Emergency~     Training Program is an innovative training strategy based on simulations designed to train~     hospital personnel to respond to obstetric emergencies. The objective of this study is to~     implement PRONTO2 in selected hospitals to measure the effectiveness of the intervention in~     influencing key behaviors in hospital practices, as well as measuring maternal and neonatal~     outcomes in intervention versus control hospitals.~   "
159564|NCT01477541|"~     Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching~     the internationally established Millennium Development Milestones (MDM) is still a distant~     goal. A fundamental part of reducing maternal and infant mortality is ensuring skilled~     attendance during pregnancy and delivery. This project uses an innovative strategy of~     integrating professional midwives and licensed obstetric nurses into rural medical centers in~     the states of Guerrero and Oaxaca, Mexico, to provide prenatal care, delivery services, and~     puerperium care. The goal of the research is to increase use of best practices in intake,~     labor, delivery, and puerperium care; decrease the use of unnecessary or harmful care; and~     improve maternal and neonatal outcomes. We posited that medical centers receiving the~     intervention would provide better care and have better maternal and neonatal outcomes than~     those that did not receive the intervention.~   "
159565|NCT01477528|"~     The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII)~     patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of~     thrombotic and bleeding adverse events associated with these regimes.~   "
159566|NCT01477515|"~     To investigate the relationship between dietary intake, body habitus, and endocannabinoid~     levels in end stage renal disease patients as compared to matched controls.~   "
159567|NCT01477502|"~     recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are~     a frequent problem, leading to significant morbidity and to a decreased quality of life.~        -  until today, there is no effective prophylaxis for UTI for patients with spinal cord~          injury.~        -  homeopathy has been shown to be an effective treatment option in several chronic~          diseases~        -  study hypothesis: the addition of homeopathic assessment and treatment to a standard~          prevention strategy for recurrent UTI will significantly reduce the number of~          symptomatic UTI per year in this group of patients compared to standard prevention alone~   "
159568|NCT01477489|"~     The purpose of this study is to determine the maximum tolerated dose of veliparib that can be~     given while a patient is receiving radiation therapy.~   "
159569|NCT01477476|"~     This is a randomized, double-blind, placebo-controlled phase 2 study. Specific aim is to~     evaluate feasibility and safety of anti-IL-1 (interleukin 1) treatment in the course of~     standard therapy for diabetic ketoacidosis in children and its effect on intracranial~     pressure.~   "
159570|NCT01477463|"~     The purpose of this study is to determine the signaling pathways and changes in gene~     expression in melanocytes of subjects with a history of non-melanoma skin cancer who are~     exposed to oral vitamin D. If vitamin D is found to inhibit a signaling pathway involved in~     the development of melanoma such as BRAF, a protein involved in cell proliferation, then oral~     vitamin D could be explored further as a chemoprevention for melanoma skin cancer.~   "
159571|NCT01477450|"~     This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse~     altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.~   "
159606|NCT01476995|"~     The objective of this study is to determine whether the finger tip images captured by the~     EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale~     that characterizes trends consistent with known diagnoses identified by medical doctors.~     Specifically, the investigators hypothesize that the organ system involving any of a series~     of known active diagnoses will be identified in the EPIC ClearView Response Scale report with~     the intention of providing potential triage capabilities.~   "
159572|NCT01477437|"~     In summary, there is a clear need to improve knowledge and self-management skills in~     adolescents with hemophilia. To date, there are no published accounts of self-management~     programs for this population. Evidence from other chronic diseases that affects teens~     suggests that by developing an interactive Internet-based program, the investigators can meet~     the educational needs of adolescents with hemophilia and improve their ability to manage~     their hemophilia. In the long-term, improved self-management should result in a smoother and~     more successful transition to adult care and improve patient outcomes.~   "
159573|NCT01477424|"~     The purpose of this study is to determine if Warfarin is affected by PA21.~   "
159574|NCT01477411|"~     The purpose of this study is to determine if Digoxin is affected by PA21.~   "
159575|NCT01477398|"~     The proposed study will measure the incidence of adverse events and the decrease in time to~     meet discharge criteria from the post anesthesia care unit when hypercapnic and hyperpnoea~     are used during emergence.~   "
159576|NCT01477385|"~     This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment~     of clinically caries lesions in enamel, with radiographic image restricted to the enamel or~     the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth.~     It also aims to compare it to the resin infiltration and to the control of proximal biofilm~     through the oral hygiene.~   "
159577|NCT01477372|"~     The purpose of this study was to assess the effectiveness of a moderated physical exercise~     program called Blooming Exercise Program (BEP) developed during pregnancy in order to control~     excessive maternal weight gain and its consequences. Additionally, other objectives of the~     study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy~     outcomes and on the perception of the pregnant's health~   "
159578|NCT01477359|"~     Recent data has shown that sarcoidosis, presenting initially with cardiac manifestations (CS)~     of either conduction system disease or cardiomyopathy and sustained VT, is not uncommon. A~     Canadian physician survey found that most physicians do not investigate for CS as a~     possibility in these situations. Thus many patients with clinically important CS are going~     un-diagnosed. A study from Finland showed that missing the diagnosis of CS in these patients'~     leads to significant mortality and morbidity.~      There are no published clinical consensus guidelines on treatment of CS. Corticosteroid~     therapy is advocated by most experts. This is based on very modest data from small~     retrospective observational studies using variable definitions of clinical response. The~     effect of corticosteroid treatment on the clinical course of CS has not been studied in~     prospective studies and will be one of the aims of this project. Recent physician surveys~     regarding CS, in Canada and the US, found that current clinical practice varies widely. The~     2008 American College of Cardiology/American Heart Association/Heart Rhythm society~     guidelines recommend implantation of a defibrillator (Class IIa recommendation) to prevent~     sudden cardiac death. The most recent Canadian device therapy guidelines do not mention CS.~      A multi-center collaborative approach to study CS is greatly needed. The investigators~     propose exactly that i.e. a multi-center prospective cohort to start to answer clinical~     questions. The investigators have formed the CANADIAN CARDIAC SARCOIDOSIS RESEARCH GROUP. The~     group includes respirologists with an interest in sarcoidosis, cardiac electrophysiologists,~     cardiac imaging specialists with extensive experience in imaging of sarcoidosis and~     biostatisticians. The research will be in two phases; a registry of current diagnostic~     approaches, treatment and prognosis, and a randomized clinical trial of the effect of~     corticosteroid treatment on the clinical course of cardiac sarcoidosis.~   "
159579|NCT01477346|"~     The purpose of this study is to determine in community-derived patients with gout the~     effectiveness, and cost effectiveness, of a nurse-led complex intervention that reflects~     recommended best practice (including patient information concerning gout, its prognosis and~     its non-pharmacological and drug options).~   "
159580|NCT01477333|"~     The purpose of this multi-center, open-label, safety and tolerability study was to assess the~     addition of oral treprostinil (UT-15C sustained release [SR] tablets) to subjects currently~     receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period,~     the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk~     test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World~     Health Organization (WHO) Functional Class, and safety assessments.~      Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were~     receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies~     (endothelin receptor antagonists [ERAs] and/or phosphodiesterase type 5 inhibitor [PDE5-I],~     if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg~     UT-15C SR.~   "
159581|NCT01477320|"~     study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral~     nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of~     incidence of overt and significant GI bleeding related to stress gastropathy.~   "
159582|NCT01477307|"~     In patients with NAFLD/NASH, changes in liver lipid composition and function tests following~     a short dietary intervention are associated with changes in gut microbiota~   "
159583|NCT01477294|"~     The main purposes of this randomized cross-over trial are to characterize and compare the~     effects of a moderate dose of caffeine intake in healthy physically active males on hydration~     and energy metabolism specifically:~        1. Total body water and its compartments (intracellular and extracellular) assessed by by~          dilution techniques, and hydration state by urine specific gravity;~        2. Total energy expenditure by double labeled water, resting energy expenditure by indirect~          calorimetry, and physical activity energy expenditure;~        3. Energy expenditure in physical activity of daily living, in particular duration and~          intensity of activity.~        4. If the changes occurred between placebo and caffeine ingestion on the main outcomes were~          dependent on specific covariates, namely body composition and dietary intake.~   "
159584|NCT01477281|"~     The objective is to evaluate the effectiveness of the safety of Daflon in decreasing symptoms~     resulting from chronic venous insufficiency when compared with Daflon.~   "
159585|NCT01477268|"~     Major depression is a very common health problem affecting older persons. The present~     standard of treatment is with medications called antidepressants. Antidepressants have been~     studied extensively in older persons with normal brain function and have been shown to be~     effective. However, certain types of brain dysfunction called executive impairment~     (inability to do higher order thinking) may lead to poor treatment outcomes. This study will~     compare how older depressed people with different levels of executive impairment respond~     differently to standard antidepressant treatment. Knowing this information will lead to more~     rational targeting of available treatments, leading to improved treatment outcomes.~   "
159723|NCT01475448|"~     The goal of this project is to understand the effect of regular practice of long distance~     running on the posture and movement control of older adults.~      For such, the investigators will conduct an experiment with longitudinal design where~     sedentary elderly individuals will be trained in long distance running for about 4 months.~   "
159586|NCT01477255|"~     This investigation seeks to determine the feasibility of an electronic diary methodology~     among pediatric cancer patients and healthy matched controls. Levels of study participation~     and compliance will be assessed to assist with determining overall feasibility. Results will~     offer insight into the effectiveness of this means of data collection with a pediatric~     oncology population, and will examine how psychosocial and contextual factors contribute to~     the resiliency that has been demonstrated by children with cancer. Findings will provide data~     for the design and implementation of a future, larger-scale study with this pediatric~     population that implements an electronic daily diary methodology.~   "
159587|NCT01477242|"~     The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this~     evaluation, the investigators will perform a multi-center, double-blind, placebo-controled,~     randomized study. The investigators assumption is that oral ondansetron prior to~     intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.~   "
159588|NCT01477229|"~     Rectal cancer is a common type of cancer occuring more frequently in men but also common in~     women. Almost 60% of the patients survive 5-years and the treatment has been continuously~     developed in the last three decades. The aim of the QoLiRECT study is to increase the~     knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and~     socioeconomic burden in an unselected population of rectal cancer patients.~   "
159589|NCT01477216|"~     The aim of this study to investigate methodological aspects that may affect glycemic index~     (GI) and insulinemic (II) values. In addition, we will measure GI and II values for typical~     Finnish carbohydrate-rich foods and provide a database of GIs for Finnish foods.~      The specific aims of this study are:~        -  to compare glycemic responses and GIs analyzed from capillary and venous blood to~          compare glucose against white bread as the reference food, and to study the effect of~          number of reference tests on GI values. For each setting of the tested parameters, we~          determined the glycemic indices of rye bread, oatmeal porridge and instant mashed potato~        -  to examine the glycaemic and insulinaemic responses of a mashed potato-based meal when a~          high fat food (rapeseed oil) or a high protein food (chicken breast) or fat, protein and~          salad together were added to the meal. Furthermore, we studied how the predicted and~          measured GI values of the mixed meal differed from each other.~        -  to examine the effects of two different coffee portions with glucose and~          caffeine-containing soft drinks on postprandial glucose and insulin responses. Further~          objectives were to study how coffee and different accompaniments affect glucose and~          insulin responses.~        -  to measure GI values for typical Finnish foods~        -  to study the effects of berries on glycemic and insulinemic responses~        -  to examine the effects of overweight and glucose tolerance on the glucose, insulin and~          lipid responses to an HGI meal and an LGI meal.Furthermore, the second aim was to study~          the effect of BMI and glucose tolerance on the GI measured.~        -  to compare methodological choices in insulin measurement~        -  to investigate the effect of alcohol on postprandial glucose and insulin responses, and~          to determine glycemic and insulinemic indices values for beer and non-alcoholic beer~   "
159590|NCT01477203|"~     MAN-BIOPSY pursues the concrete research question whether novel biological and~     psycho-physiological clusters or categories can be defined to improve treatment and minimize~     side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and~     endocrinological parameters. One major aspect of our research approach is its focuses on the~     identification of dysfunctions in fundamental information processing mechanisms and~     neurocomputational mechanisms, and is not restricted to symptom-oriented tasks.~      The main objectives of MAN-BIOPSY are therefore~        -  to identify biological and psycho-physiological parameters for major depressive~          disorders and anxiety disorders, and~        -  to identify predictive markers for treatment response and type/severity of side effects~          for these disorders.~   "
159591|NCT01477190|"~     This is a blinded randomized controlled trial in patients undergoing laparoscopic colon~     surgery. The aim of this study is to assess whether spinal analgesia with a mixture of~     bupivacaine and morphine provides better pain relief than systemic morphine in a group of~     patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS)~     program.~      Twenty patients will receive spinal analgesia and twenty patients will receive only Patient~     Control Analgesia (PCA).~   "
159592|NCT01477177|"~     The purpose of this pilot study is to provide an initial assessment of the feasibility,~     safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low~     grade and high grade dysplasia by use in a small number of patients so as to support, or~     otherwise, the development of a full-scale trial.~   "
159593|NCT01477164|"~     Muscle proteins accumulate damage during aging and leads to the loss of muscle mass and~     function in older people. Exercise can increase the making of new proteins and removal of~     older proteins, but it is not known if the effect changes with aging or type of exercise. The~     investigators will determine the ability for endurance, resistance, or a combination of~     exercise training to remove older-damaged proteins and make newer-functional muscle proteins~     in groups of younger and older people. The investigators will particularly study protein that~     are involved with energy production (mitochondrial proteins) and force production~     (contractile proteins).~      Hypothesis 1: Older people will have greater accumulation of damaged proteins than younger~     people.~      Hypothesis 2: Aerobic exercise will decrease the accumulation of damaged forms of contractile~     and mitochondrial proteins in younger and older people.~      Hypothesis 3: Resistance exercise will decrease the accumulation of damaged forms of~     contractile proteins in younger and older people.~   "
159594|NCT01477151|"~     Anesthesia practice in the 21st century is increasingly outcomes-oriented and evidence-based,~     but there remain significant gaps in our knowledge, even for commonly-encountered clinical~     situations. Currently, the two most commonly used drugs used for maintenance of anesthesia in~     cardiac surgical patients are isoflurane and sevoflurane. There is a belief among many~     cardiac anesthesiologists that sevoflurane is a better cardiac anesthetic than isoflurane,~     but there is very little data to support this notion. In fact, very little is known about~     their comparative effects on important patient outcomes because there has not been a large~     head-to-head prospective randomized clinical trial. This project will supply the data~     necessary to critically compare the two anesthetics.~   "
159607|NCT01476982|"~     The primary objective of this feasibility study is to determine whether it is possible to~     conduct a study of the ClearView scan among patients under evaluation for acute~     cardiovascular events, as well as give insight into the performance of the ClearView scoring~     algorithm with respect to this patient population. The EPIC™ scan is a bio-electrographic~     tool that may assist the health care provider in rapid assessment of the systemic origin of~     the patient's presenting symptom(s). The EPIC ClearView is a potentially valuable resource~     that may benefit an emergency department (ED) by offering expedited chest pain etiologic~     differentiation capabilities. The subsequent results have the potential to include more rapid~     chest pain patient diagnosis and appropriate disposition of non-cardiac chest pain (rule~     out MI); optimized precious resource expenditure (nursing, physician, inpatient or~     observation bed, etc.); lower costs to facility, patient and insurance company; and greater~     patient satisfaction rates due to decreased ED wait time.~   "
159595|NCT01477138|"~     Background:~        -  Potential negative effects of pacing in the RV-apex are well documented~        -  However, study results comparing septal / RVOT-pacing versus RV-apical pacing~          controversial.~        -  The optimal pacing mode in SSS (DDDR versus AAIR) is unclear, as the DDD (R) mode with~          an AV delay ≤ 220 ms should be the preferred pacing mode, according to the DANPACE trial~          [DANPACE, ESC 2010, Stockholm].~      Aim:~      - to evaluate chronic effects of proven right ventricular septal compared to minimized right~     ventricular septal pacing in patients with SSS~      Inclusion criterion:~      -Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)~      Exclusion criteria:~        -  Life expectancy < 2 years~        -  Age <18 years~        -  Noncompliance with regard to participation in the study~        -  Pregnancy~        -  AV block ° 2 and higher~        -  Permanent atrial fibrillation~        -  Heart failure NYHA III and IV, reduced LV-EF <40%~        -  ICD indication~        -  Acute coronary syndrome. PCI or CABG <3 months~        -  Heart transplant~        -  Placement of septal RV electrode is not possible~      Study design:~        -  Prospective, monocentric, randomized, double-blinded~        -  Run-in phase: for weeks AAI [R]-DDD [R]~        -  Randomization: two groups A) septal right ventricular chamber pacing: mode DDD [R]~          versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].~        -  FU: 6 and 12-months~      Primary endpoints:~      -LV ejection fraction and end-systolic LV volume after 12 months.~      Secondary endpoints:~      -LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden,~     % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope;~     QoL scores (SF-36) after 12 months.~      Statistics/sample size estimation:~      In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups~     after 12 months:~        -  90% power/alpha 5%: 84 patients per group~        -  80% power/alpha 5%: 63 patients per group~             -  10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1~               error Analysis intention-to-treat and based on the finally programmed pacing mode.~      Material~        -  PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)~        -  pacing leads: market-released standard active electrodes~        -  RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow~          <150 ms / inferior axis)~   "
159596|NCT01477125|"~     The purpose of this study is to evaluate whether computerised working memory training~     improves cognitive performance, ADHD symptoms, psychosocial functioning and quality of life~     in adults with ADHD, from psychiatric outpatient clinics (N=100) as well as from a~     high-security prison facility (N=50).~   "
159597|NCT01477112|"~     Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms,~     the objective is to determine the effect of supplementation with β-carotene to type 2~     diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant~     plasma capacity, using doses similar to the daily nutritional requirement.~   "
159598|NCT01477099|"~     The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12%~     could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may~     be an important reservoir of pathogens that could cause pneumonia.~   "
159599|NCT01477086|"~     Sarcopenia is the loss of muscle mass and function that accompanies aging. The term~     sarcopenia comes from the Greek sarx (flesh) and penia (loss).~      Sarcopenia is a topic of great interest to geriatricians, and from 2010 discussing the~     possibility of considering it as a geriatric syndrome.~      Diagnostic criteria are reduced muscle mass, reduced strength and impaired physical~     performance. The presence of muscle mass reduction set presarcopenia diagnosis, when combined~     with one of the other two are talking about sarcopenia and when are the three is defined as~     severe sarcopenia.~      The hypothesis of our study is that sarcopenia is highly prevalent in older people with hip~     fracture. The increase in inflammatory indices of older people, along with bed rest,~     represent factors that accelerate the development of sarcopenia. These factors together could~     be the base of the high percentage of patients who do not recover the degree of autonomy~     before the fracture.~   "
159600|NCT01477073|"~     The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a~     multiple dose administration of FSH-GEX™ in healthy pituitary-suppressed female volunteers,~     in comparison with two marketed comparator products.~   "
159601|NCT01477060|"~     Target Population: female patients with HER2-negative, ER and/or PgR positive breast cancer~     in progression after first-line hormonal therapy.~      The study rationale is based on the potentiality of reversing endocrine-resistance by~     Lapatinib~        -  Activity on compensatory-adaptive mechanisms of hyperactivity of signals generated by~          HER2 family~        -  Modulation of energy balance and signals associated to survival through AMPK activation~          (via Calmodulin) Metformin~        -  Indirect mechanism, through reduced insulin receptors and IGFR stimulation, with reduces~          proliferative effects downstream~        -  Direct mechanism, through AMPK activation (via LKB1), with reduced protein synthesis~          (mTOR inhibition) and increased availability of intracellular energy Lapatinib and~          Metformin~        -  AMPK Doubleactivation, through different potentially additional mechanisms.~        -  Inhibition of proliferative mechanisms for interference on various intracellular target~             -  IR (A e/o B); IGFR~             -  EGFR; HER2~      Primary objectives :~      1. To assess the rate of patients free from disease progression at 3 months from~     randomization~      Secondary objectives :~        1. To assess the overall response rate~        2. To assess the duration of response~        3. To assess 3-years overall survival rate~        4. To assess tolerability of each proposed treatment Female patients with HER2-negative, ER~          and/or PgR positive breast cancer in progression after first-line hormonal therapy will~          randomized to receive: hormonal therapy + lapatinib or hormonal therapy + metformin or~          hormonal therapy + metformin + lapatinib with a ratio 1:1:1.~      For each arm of the study the following sample size is required:~        -  First step: 23 patients, for a total of 69 patients in all 3 arms~        -  Second step: further 33 patients, for a total of 168 patients in all 3 arms.~   "
159602|NCT01477047|"~     Prolonged wound drainage following total joint replacement surgery has been shown to be a~     predictor of postoperative infection. Several factors have been associated with delayed wound~     healing and increased risk of infection. Namely hypertension, obesity, diabetes, smoking and~     autoimmune disease have been shown to have a detrimental effect on wound healing. The purpose~     of this study is to verify those findings and determine additional pharmacological, surgical~     and patient related factors that may result in prolonged wound drainage, prolonged hospital~     stay and increased risk of infection~   "
159603|NCT01477034|"~     Chronic, low-grade adipose tissue inflammation is a major risk factor for type 2 diabetes~     mellitus. The cause of adipose tissue inflammation has remained largely unclear. We~     hypothesize that vitamin D deficiency predisposes individuals to the development of adipose~     tissue inflammation, and that treatment of vitamin D deficient subjects with high dose~     vitamin D will reduce adipose tissue inflammation.~   "
159604|NCT01477021|"~     This phase I trial studies the side effects and how well giving autologous T cells with~     cyclophosphamide works in treating patients with soft tissue sarcoma that is metastatic or~     cannot be removed by surgery. Biological therapies, such as cellular adoptive immunotherapy,~     may stimulate the immune system in different ways and stop cancer cells from growing. Drugs~     used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving autologous~     T cells together with cyclophosphamide may kill more tumor cells.~   "
159605|NCT01477008|"~     The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic~     Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral~     and osteochondral lesions located on the medial femoral condyle, lateral femoral condyle, or~     trochlea of the knee. The hypothesis is that the BiCRI provides an improvement in pain and~     function as compared to baseline, that is no worse than marrow stimulation at 1 year.~   "
159609|NCT01476956|"~     Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug)~     DMARD therapy or about to change DMARD therapy.~      Disease activity will be monitored systematically every 3 months by the Disease Activity~     Score.~      Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be~     made according to specific recommendations for patients receiving these therapies.~      Biomarker samples will be collected every 3 months and prior to change in DMARD and/or~     anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for~     biomarker studies and processed according to the international committee of Outcome Measures~     in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A~     urine sample (20 ml) will also be taken and processed as for serum.~      Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).~      Patients will be followed for 2 years.~   "
159610|NCT01476943|"~     The primary purpose is to describe the pattern of Belatacept use at the time of transplant~     and up to three years post-transplantation for all Belatacept treated patients.~   "
159611|NCT01476930|"~     Migraine is the most common recurrent headache. Current therapy of migraine headache consists~     of multiple drug groups for control of attack and prophylaxis against recurrent attacks.~     Emerging alternative medicine worldwide led investigators to evaluate the efficacy of cupping~     therapy plus SERKANGABIN syrup in treatment of migraine headache. Severity, duration and~     frequency of attacks of migraine headache evaluated in two groups during six months from~     presentation.~   "
159612|NCT01476917|"~     The Study is a multi-center, prospective, open label, single-arm, three-month, long-term~     study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA).~     The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.~   "
159613|NCT01476904|"~     E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be~     able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in~     a double-blinded manner.~   "
159614|NCT01476891|"~     For people with cancer, in-person Mindfulness-Based Stress Reduction (MBSR) participation can~     decrease stress symptoms, mood disturbance, and fatigue, as well as enhance personal growth~     and spirituality, and improve quality of life and sleep. Online MBSR may improve the~     accessibility of MBSR programs to underserved cancer patients who are unable to attend~     available in-person groups. This study will examine whether patients are willing to~     participate and complete the program, and also whether the online program improves mood and~     stress.~   "
159615|NCT01476878|"~     The investigators plan to study high dose, single treatment radiation, using a plastic mask~     instead of a head frame that pins into a patient's skull. The investigators need to (1)~     quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that~     without the head frame the tumour control rate and risk of complications are similar to our~     previous experience using the head frame.~   "
159616|NCT01476865|"~     The purpose of this study is to establish the normality of sonographic synovial measures in~     joints more affected in rheumatoid arthritis patients and establish, in those joints, a~     sonographic value of synovium predictive of rheumatoid arthritis.~   "
159617|NCT01476839|"~     This phase I clinical trial studies the side effects and best dose of radiolabeled monoclonal~     antibody therapy when given together with combination chemotherapy before stem cell~     transplant and to see how well it works in treating patients with primary refractory (did not~     respond to treatment) or relapsed (returned after treatment) Hodgkin lymphoma. Radiolabeled~     monoclonal antibodies can find cancer cells and carry cancer-killing substances to them~     without harming normal cells. Drugs used in chemotherapy, such as carmustine, etoposide,~     cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or stopping them from spreading.~     Giving radiolabeled monoclonal antibody therapy together with combination chemotherapy may~     kill more cancer cells~   "
159618|NCT01476813|"~     dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF~     in COPD patients.~   "
159619|NCT01476800|"~     The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose~     ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone~     and in combination with ketoconazole in healthy adult volunteers.~   "
159620|NCT01476787|"~     The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide~     and rituximab in controlling the Follicular Lymphoma disease and also increase the length of~     response compared to the available standard combination chemotherapy treatment for Follicular~     Lymphoma.~   "
159621|NCT01476774|"~     This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group,~     multi-center, safety and efficacy study.~   "
159622|NCT01476761|"~     The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device~     in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in~     a post-market approval study.~   "
159623|NCT01476748|"~     The purpose of this study is to find out how much a trocar might slide during a typical~     laparoscopic hysterectomy. We also want to find out if there is a difference between how much~     three commonly used trocars slide and if a device called LaproStop has an effect on the~     slippage.~      Patients will be randomly assigned into the different trocar groups. After this assignment~     has been made, we will then assign the Laprostop to one of the two trocars by chance.~   "
159624|NCT01476735|"~     This is a prospective, randomized, single-blind study designed to evaluate the influence of~     individual approach on bowel preparation quality for colonoscopy. The investigators compare~     split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified~     split-dose PEG regarding predictors of inadequate preparation for colonoscopy.~   "
159625|NCT01476722|"~     The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting~     solution in silicone hydrogel and soft contact lens wearers.~   "
159656|NCT01476319|"~     This study is planning to develop the audiovisual videos and determine whether educational~     videos are superior to routine discussion for informing patients in the emergency department~     (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy.~     Eligible patients will be approached when patients will be scheduled and waiting for~     receiving percutaneous cholecystostomy in the emergency department.~   "
159626|NCT01476709|"~     Rationale: evaluate the potential of the photonic needle (photonic needle technology) to~     discriminate tissues that are relevant to recognize during intraforaminal (transforaminal)~     epidural injection on lumbar level.~      Objective: The primary objective of this study is to investigate the potential of the~     photonic needle to discriminate between correct and incorrect placement of the needle tip in~     the target area of the procedure (M4 - tissue), as confirmed by contrast-enhanced~     fluoroscopy. The secondary objectives are to investigate the differences in the optical~     signals obtained with the photonic needle at a set of different pre-defined positions (M1, M2~     and M3) encountered along the needle trajectory during above-mentioned procedures, and to~     detect potential intravascular positioning of the needle-tip at the target point (M4 -~     blood), Study design: this is a single blind observational study. Study population: Patients~     who have radicular pain on lumbar level, for example caused by disc herniation, and/or~     lateral recessus stenosis and/or radiculopathy eci.~      Main study parameters/endpoints: The main study parameters are: 1) successfully acquired~     diffuse reflectance spectra obtained at measurement point M4: midforaminal, halfway the~     foramen (the target treatment location) as encountered during image-guided intraforaminal~     injections on lumbar level, 2) confirmation of target area with fluoroscopy and injection of~     contrast fluid (gold standard), 3) Certainty score on a 3-point scale (1 = uncertain, 2 =~     certain, 3 = very certain) will be provided by the physician. The type of tissue present at~     the needle tip will be based on the information available from imaging .~      The secondary study parameters are: 1) successfully acquired diffuse reflectance spectra~     obtained at measurement points M1-M3: M1 in muscle, M2 extra-foraminal, M3 foraminal at a~     distance 1/3 of the diameter of the foramen from the entrance of the foramen, as encountered~     during image-guided intraforaminal injections on lumbar level, 2) successfully acquired~     diffuse reflectance spectra obtained at measurement point M4, in case of a vascular puncture~     (M4-blood), 3) confirmation images by ultrasound imaging at location M1 as described above,~     4) confirmation images by fluoroscopy at locations M2 and M3, 5) digital subtraction~     angiography images after contrast injection at location M4, confirming vascular penetration~     (gold standard for vessel puncture), 6) Certainty score on a 3-point scale (1 = uncertain,~     2 = certain, 3 = very certain) provided by the physician for assignment of the type of tissue~     present at the needle tip, based on the information available from imaging at M1 and at M4.~   "
159627|NCT01476696|"~     The purpose of this study is to determine the correct prasugrel dosage to be given to~     children with sickle cell disease (SCD).~   "
159628|NCT01476683|"~     This study is designed to compare the pharmacokinetics of four products used for treatment of~     acute diarrhea.~   "
159629|NCT01476670|"~     The normal cerebral blood flow is guided by factors such as cerebral autoregulation (CA) and~     carbon dioxide reactivity (CO2R). Authors have demonstrated that CA and CO2R may be impaired~     in presence of intracranial tumors.Most studies pertaining to assessment of CA and CO2R in~     patients with brain tumors is limited to supratentorial tumors. Due to their anatomic~     location, posterior fossa tumors result in obstruction of ventricular outflow, produce~     hydrocephalus and features of raise intracranial pressure (ICP). It is possible that lesions~     in the posterior fossa may affect CA and CO2R. It should also be noted that posterior fossa~     surgeries are carried out in positions such as prone, lateral and sitting. Altered surgical~     positions themselves affect systemic hemodynamics which may influence cerebral blood flow;~     with presence of anesthetics further compromising the blood flow to the brain. Understanding~     the homeostatic mechanisms of CA and CO2R may help in deciding proper positioning of patients~     and maintenance of intraoperative hemodynamic.~      The aim of this observational study was to evaluate CA and CO2R in patients with posterior~     fossa tumor prior to surgical decompression of the lesion.~   "
159630|NCT01476657|"~     The purpose of this study is to determine the safety, maximum tolerated dose and~     pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.~   "
159631|NCT01476644|"~     Hypothesis 1: Self-reported health-related quality of life decreases as vision impairment~     worsens in subjects with glaucoma.~      Hypothesis 2: Changes in health-related quality of life are associated with changes in~     clinical measures of vision and performance-based measures of visual function.~   "
159632|NCT01476631|"~     Hypothesis 1: Exercise will decrease serum markers in a dose response manner.~      Hypothesis 2: Participants in the 60 minute intervention will have significantly higher~     physical activity levels than those in the 30 minute intervention at three months.~   "
159633|NCT01476618|"~     The purpose of this study is to gather information from VISN 19 Denver VA mental health~     professionals regarding their perspectives of necessary resources to provide best practice~     mental health service to Operation Iraqi Freedom (OIF)/ Operation Enduring Freedom (OEF)~     Veterans. Specifically, this study aims to describe provider perspectives regarding the~     following: a) clinical needs of OIF/OEF Veterans; b) collaboration and referral processes; c)~     barriers to providing optimal treatment to this cohort d) provider needs and resources that~     may improve service delivery to this cohort; e) provider perspectives regarding psychiatric~     outcomes in this cohort; and f) professional satisfaction. Support for this study is provided~     by previous research evaluating Veteran's Administration (VA) needs to provide service to~     OIF/OEF Veterans (Sayer, et al. 2009; Friedmann-Sanchez, et al. 2008).~      The above information will be obtained using semi-structured interview. Hypotheses are not~     provided as this is an exploratory qualitative study.~   "
159634|NCT01476605|"~     While evidence does not identify any conventional therapy as definitive for chronic lateral~     epicondylosis (CLE, tennis elbow), basic science and limited pilot level trials support~     rigorous assessment of prolotherapy (PrT) and platelet-rich plasma (PRP) as therapy for CLE.~     The proposed study will conduct a pilot RCT assessing 2 PrT solutions and PRP injections~     commonly used in the treatment of moderate-to-severe tennis elbow using clinical,~     biomechanical and radiological outcomes. Data from this study will support a future~     confirmatory study to find an effective treatment for moderate-to-severe tennis elbow. In~     support of this goal, the investigators propose the following research questions.~      Does PrT or PRP, compared to waitlist control:~        1. improve pain- and function-dependent, CLE-specific quality of life among adults with~          CLE, as assessed by a validated questionnaire, the elbow-specific Patient-Rated Tennis~          Elbow Evaluation?~        2. improve upper extremity performance among adults with CLE as assessed by a blinded~          assessor using elbow-specific, effort-dependent biomechanical measures of grip strength~          (pain-free and maximal), stiffness, effective mass and damping~        3. improve the radiologic appearance of several pathologic features of CLE as evaluated~          using imaging studies of lateral elbow structures: ultrasound to assess a)~          neovascularity (color Doppler), b) hypoechogenicity (grayscale US), and c) tendon~          stiffness (acousto-elastic strain gauge technique) using standardized, 0-3 severity~          scales, and d) MRI to assess the overall common extensor tensor tendon disease severity~          using a standardized 0-3 scale?~        4. provide satisfying treatment to subjects as assessed by a treatment satisfaction survey~          and a qualitative exit interview?~   "
159635|NCT01476592|"~     Resveratrol has been shown to activate a protein called Notch-1. Signaling of Notch-1 has~     been shown to prevent tumor cell growth. Resveratrol has also been shown to prevent growth of~     tumors in mice. The purpose of this study is to examine the effects of resveratrol and~     Notch-1 on neuroendocrine tumor tissue and to examine how people with neuroendocrine tumors~     who take resveratrol for up to three months tolerate the product.~   "
160253|NCT01468480|"~     Application of four different pulp capping methods on human sound premolars after intentional~     exposure of the buccal pulp horn through a class one occlusal cavity.~   "
159636|NCT01476579|"~     This study is evaluating the performance of modern CT coronar angiography with low radiation~     technique compared to conventional invasive coronar angiography. The patients recruited will~     already be accepted for invasive coronary angiography based on clinical presentation, ECG and~     biochemical parameters. An all-comers design to avoid selection bias and no additional~     B-blockers will be used prior to CT angiography. The hypothesis is that it is possible to~     rule out significant coronary artery disease with sensitivity > 95 % and negative predictive~     value > 95 % with very low radiation doses.~   "
159637|NCT01476566|"~     This study will explore the possible effect of a tailored educational intervention towards~     general practitioners in Norway, in order to improve the quality of treatment for heart~     failure in general practice.~   "
159638|NCT01476553|"~     A Japanese study showed that the additional use of an Extensive Intraperitoneal Lavage~     (EIPL), i.e. an extensive washing of the abdominal cavity with water, during surgery for~     gastric cancer can lead to a significant increase in survival. However, the study was~     confined to patients in whom upon commencing surgery, free peritoneal tumor cells were~     detected, which is only a small fraction of patients.~      The primary objective of our study is to assess in all patients undergoing removal of the~     stomach and adjacent lymph nodes for stomach cancer, if EIPL can eliminate free peritoneal~     tumor cells which have been present at the beginning of the surgery or after the stomach and~     lymph node removal. Secondary objectives are to assess how often free peritoneal tumor cells~     occur in patients with stomach cancer, how often surgical resection itself leads to a release~     of tumor cells, the safety of the EIPL procedure, and disease-free and overall survival of~     patients undergoing EIPL. Based on the outcome of this japanese study we want to test with~     special laboratory methods why this lavage leads to a better outcome.~      Specifically, the trial will test the hypotheses that a) lymph node dissection causes a~     release of tumor cells in the abdominal cavity, and b) EIPL eliminates free peritoneal tumor~     cells.~   "
159639|NCT01476540|"~     Anorexia Nervosa (AN) is a challenging, chronic, refractory illness with the highest~     mortality rate of any psychiatric condition. Advances in the neuroimaging, genetics and~     neurobiology of AN has led to a greater understanding of its underlying pathophysiology,~     although few significant advances in treatment have been made in the last half-century. The~     central features of AN, which include an intense fear of gaining weight, a refusal to~     maintain a normal weight, as well as significant anxiety, anhedonia and dysphoria surrounding~     food, have been linked to dysfunction in key brain structures and circuits. Deep Brain~     Stimulation (DBS) is a neurosurgical procedure that involves the insertion of electrodes into~     structures believed to drive pathological behavior. The procedure is approved for the~     management of movement disorders, such as Parkinson's Disease, and has shown promising early~     results in the management of some psychiatric conditions, such as Major Depression. The~     purpose of this study is to explore the safety and initial efficacy of DBS, in patients with~     treatment resistant AN.~   "
159640|NCT01476527|"~     Bipolar Disorder (BD) is among the most comon and challenging conditions in psychiatry.~     Although episodes of mania and hypomania define the different types of the disorder, the~     clinical picture is one dominated by depressed mood and agitation. The mainstay of BD~     treatment has thus far been pharmacologic, but many patients remain severely disabled by~     their condition, despite the best available medical treatment. The successful use of deep~     brain stimulation (DBS) in movement disorders, and its promising results in major depressive~     disorder (MDD), has led researchers to consider its use in highly selected refractory cases~     of BD. Evidence form the imaging and circuitry literature suggests that similar underlying~     dyfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key~     structures, can lead to an amelioration of symptoms and mood stabilization. Here, we propose~     a phase I clinical trial to evaluate the safety of DBS in BD.~   "
159641|NCT01476514|"~     Mutations in genes affecting pain transmission start to be known, the investigators are~     investigating a mutation in a glycine channel, which has an influence on pain modulation.~     Pain modulation is the ability of the central nervous system to enhance or diminish the~     sensation of pain. The investigators therefore will test patients and healthy volunteers with~     quantitative sensory tests, basically determining the point at which a stimulation just~     starts to induce pain. These tests are reliable and permit a direct comparison between~     healthy volunteers and patients with the affected glycine gene.~   "
159642|NCT01476501|"~     Diabetes is a life-long disease that is getting more common in Canada. One of the most common~     problems in people with kidney disease is diabetes and low bone mineral density (BMD). This~     can lead to a higher chance for broken bones, infection and life-long health problems. The~     most common reason for having low BMD is not getting enough vitamin D (Vit D) in your diet~     and not having enough sunlight. This is very common in Canada (especially in northern~     Alberta) because winter is very long. Most people also don't eat or drink enough foods that~     are high in Vit D (like milk) and so they don't have enough Vit D in their body to make~     healthy bones. This can mean the only way to get enough Vit D in your body for your bones~     when you have kidney disease is to take some extra vitamin D in a pill. Most people are not~     aware that they have poor bone health until they break a bone. Broken bones can really hurt~     and can prevent a person from being able to walk and take care of themselves. Right now, we~     are not sure exactly how much Vit D people with diabetes and kidney disease need to take to~     prevent them from having low BMD or how often they need to take it. Our plan is to study the~     effect of two ways to take Vit D pills (every day or once a month) on overall Vit D status~     and on bone health in adult patients with diabetes and chronic kidney disease and see how~     this influences their quality of life.~      Hypotheses:~        1. Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result~          in significantly improved overall vitamin D status and improved markers of bone health~          in adult patients with diabetic nephropathy.~        2. Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved~          patient adherence and satisfaction with vitamin D supplementation when compared to daily~          dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone health~          parameters, which will result in an increased quality of life and sense of well-being.~   "
159643|NCT01476488|"~     This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable~     pediatric kidney transplant recipients.~      Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and~     after that, the same dose of advagraf will be prescribed. The patients will have another~     pharmacokinetic study of tacrolimus after conversion to advagraf.~   "
159676|NCT01476059|"~     Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of~     children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving~     the association Fluticasone 250 mcg/dose and Salmeterol 50 mcg/dose twice a day.~      ADERE PROJECT (Pediatric)~   "
159677|NCT01476046|"~     The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated~     after dosing. The study will also investigate how GSK1995057 is taken up, metabolised~     (chemically broken down), distributed through the body and excreted, and what some of the~     effects of the study drug are.~   "
159644|NCT01476475|"~     Primary Objective:~        -  The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio~          combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as~          evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants~          treated with metformin.~      Secondary Objectives:~        -  To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:~             -  Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose~               and glucose excursions during a standardized meal test;~             -  Percentage of participants reaching HbA1c <7% or ≤6.5%;~             -  7-point Self-Monitored Plasma Glucose (SMPG) profile;~             -  Body weight;~             -  Insulin glargine dose~             -  Fasting Plasma Glucose (FPG);~             -  Percentage of participants requiring rescue therapy during the 24-week open label~               treatment period;~        -  To assess safety and tolerability of insulin glargine/lixisenatide FRC.~   "
159645|NCT01476462|"~     Development of a second neoplasm (SMN) during or after therapy for childhood acute~     lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In~     this international study we analyze subtypes of SMN in relation to their initial leukemia~     characteristics and treatment, and their subsequent overall survival.~   "
159646|NCT01476449|"~     This study is to see whether treating diabetic retinal swelling with ranibizumab injections~     into the eye monthly is better than treating diabetic retinal swelling with ranibizumab~     injections into the eye less frequently.~   "
159647|NCT01476436|"~     Low carbohydrate diet may influence the plasma lipid levels.~   "
159648|NCT01476423|"~     This observational registry is conducted in Europe, Asia, Africa and the United States of~     America (USA).~      The purpose of the registry is to evaluate the efficacy and safety of activated recombinant~     human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during~     invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or~     present refractoriness to platelet transfusions. Attention will be directed towards~     complications related to thrombo-embolic events and concomitant medications especially~     antifibrinolytics.~   "
159649|NCT01476410|"~     This phase II trial studies how well giving brentuximab vedotin together with combination~     chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin~     lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block~     cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such~     as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine~     together may kill more cancer cells.~   "
159650|NCT01476397|"~     This is a growth study of full-term, formula-fed infants randomized to receive a partially~     hydrolyzed whey protein formula with and without probiotics for the first four months of~     life. It is hypothesized that there will be no difference in growth between the two groups.~   "
159651|NCT01476384|"~     Aging is accompanied by a progressive loss of skeletal muscle mass and strength, leading to~     the loss of functional capacity and an increased risk of developing chronic metabolic~     disease. One of these metabolic diseases interacting with muscle mass is Diabetes Mellitus~     type 2. Diabetes Mellitus type 2 is characterized by high blood glucose in the context of~     insulin resistance and relative insulin deficiency. It has become clear that amongst its many~     actions, insulin is also a vasoactive hormone. Its effect to cause endothelial-nitric oxide~     dependent vasodilation is physiologic and dose dependent. Recent data suggest that insulin's~     metabolic and vascular actions are closely linked. This also means that an increase in~     microvascular perfusion following food intake is more resistant to postprandial insulin~     release. This physiological process is brought into prominence with increasing age, and even~     more in type 2 diabetics, and contributes to diminishing glycaemic control. In the present~     study the investigators will investigate the impact of postprandial insulin release on~     microvascular recruitment in the oral cavity.~   "
159652|NCT01476371|"~     The purpose of this study is to determine the effectiveness, with respect to symptoms and~     systemic inflammatory level, of mindfulness-based group treatment compared with normal~     treatment in patients diagnosed with minor to moderate mental disorders. The hypothesis is~     that mindfulness group-treatment 1) will be at least as effective as normal treatment in~     reducing psychiatric symptoms; 2) will increase quality of life compared with normal~     treatment; 3) will be costeffective compared with normal treatment; and 4) will reduce~     inflammation-related markers. The study will be conducted at primary care centers in Skåne,~     Sweden. We will assess the effect of mindfulness-based group treatment on psychiatric~     symptoms, quality of life, and health (as rated by the patients themselves) as well as~     inflammatory markers.~   "
159653|NCT01476358|"~     Vitamin A supplementation (VAS) significantly reduces all-cause mortality when given after 6~     months of age, but has a null or detrimental effect when given between 1-5 months. Studies of~     neonatal VAS (NNVAS) have produced conflicting findings. These age-pattern variations might~     result from immunological interactions between VAS and vaccines. The potential efficacy of~     NNVAS is being retested in 3 large new intervention trials with mortality as endpoint.~     Complementary mechanistic studies in animals and in human infants in The Gambia (this~     proposal) and Bangladesh have been commissioned to run in parallel.~      The investigators will use a 2-arm double blind RCT to test whether NNVAS modulates the early~     ontogeny of human immune development. Neonates, recruited through a peri-urban clinic in The~     Gambia, will receive either 50,000 International Units (IU) VAS orally within 48 hours of~     birth (intervention group, n=100) or a placebo (control group, n=100). Male and female~     neonates will be randomized separately at enrolment for later analyses by sex. All infants~     will be followed up from birth to age 1 year. A broad panel of immunological outcomes will~     examine whether NNVAS: a). normalises thymic development (thymic index by ultrasound); b).~     skews mycobacterial and recall antigen responses towards a Th2 profile; c). diminishes Th1~     and Th17 reactivity to mycobacterial and recall antigens; d). diminishes the tuberculin skin~     test (TST) response; e). causes increased innate immune reactivity; f). increases the~     frequency of circulating regulatory T cells (Tregs) expressing gut homing receptors; g).~     enhances B cell immune responses after routine vaccination (increase of B cell numbers and~     activation status); h). increases circulating IgA in mucosal immune compartment, especially~     oral polio vaccine (OPV) specific IgA post-vaccination; i). decreases bacterial~     translocation, by improving mucosal barrier function; and j). decreases markers of infection~     or inflammation. Growth and morbidity will also be assessed.~   "
159654|NCT01476345|"~     The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of~     LY2963016 compared to those of basal insulin. The study will also gather information on the~     safety and tolerability of LY2963016 in healthy participants.~      Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout~     period). There are 4 study periods.~   "
159657|NCT01476306|"~     The investigators will conduct a two-arm, parallel group, randomized comparative~     effectiveness study across two sites to increase specialty access and improve care for~     individuals with Parkinsonism and their caregivers. Twenty individuals with Parkinsonism will~     be recruited from Johns Hopkins University and the University of Rochester (approximately ten~     from each site). They will then be randomized to either continue their usual in-person care~     with a specialist or to receive care with their specialist via telemedicine in their home.~     Following an in-person baseline/screening visit, approximately ten individuals in the first~     arm (virtual house calls) will receive three visits with a movement disorder specialist via~     telemedicine (using web-based video conferencing) in their home. Approximately ten~     individuals in the second (control) arm will receive three in-person visits at an academic~     medical center with the same specialists. Approximately two weeks after the completion of~     each clinical visit, a nurse or coordinator will call the patient to call to address any~     questions or ensure appropriate understanding of the recommendation (for both telemedicine~     and control arms). Overall, the study - consistent with a national priority for comparative~     effectiveness research - will compare the use of telemedicine to manage Parkinsonism to usual~     care.~   "
159658|NCT01476293|"~     The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects~     receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an~     indication that the PIV is leaking fluids outside of the vascular system. The study~     hypothesis is to demonstrate that changes in the optical signals of the non-invasive~     monitoring medical device will detect infiltration and extravasation events.~   "
159659|NCT01476280|"~     Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor~     antagonists and this randomized double blind study was designed to compare efficacy of~     ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator~     hypothesized that palonosetron would have stronger and longer lasting antiemetic effect~     compared with ramosetron and evaluated the patients for the first 48 hours after surgery.~   "
159660|NCT01476267|"~     This single center, open-label, non-randomized, one-treatment, one-period study will evaluate~     the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in~     male healthy volunteers.~   "
159661|NCT01476254|"~     The purpose of this study is to describe the magnitude of respiratory complications after~     laparoscopic hysterectomy and cholecystectomy.~   "
159662|NCT01476241|"~     The investigators main endpoint was focused on the analysis of the type, rate and the impact~     of different clinical parameters on the complications of the PEG tube placements performed at~     the Department of Otorhinolaryngology - Head and Neck Surgery since October 2008. In~     addition, the investigators aimed to compare the results with a historic cohort patient group~     (September 2005 - October 2008) sent to the Department of Surgery for PEG tube placement in~     order to evaluate the results of the changed routine.~   "
159663|NCT01476228|"~     The main objective of the study is to evaluate the use of EEG in the management and follow-up~     of neuropsychiatric disorders. Secondary objectives are therefore better understanding of the~     pathological activations in neural network during neuropsychiatric disorders, their clinical~     evolution and response to therapies.~   "
159664|NCT01476215|"~     This proof of principle PK study will allow GSKCH to select the most favorable sustained~     release formulation among 3 prototypes to move to the next stage of drug development.~   "
159665|NCT01476202|"~     This study is designed to assess the ability of the mint nicotine mouth strip to relieve~     provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.~   "
159666|NCT01476189|"~     A repeat dose pharmacokinetic study investigating two paracetamol formulations~   "
159667|NCT01476176|"~     This PK study is designed to show bioequivalence between the study treatments.~   "
159668|NCT01476163|"~     This program allows physicians to request permission from Amicus Therapeutics (Amicus) for~     treatment access to migalastat hydrochloride (HCl) for specific adult patients with Fabry~     disease. Treatment is open label for 6 months with renewal every 6 months.~   "
159669|NCT01476150|"~     1. To establish a BMD reference database of Beijing's urban population, China.~        2. To determine the prevalences and risk factors of osteoporosis and osteopenia in~          Beijing's urban population, China.~        3. To describe the 25OHD level and estimate the prevalence of vitamin D insufficiency and~          deficiency of Beijing's urban population, China.~        4. Estimation of the prevalence of osteoporotic fracture (vertebral) in over age of 60 of~          Beijing's urban population, China.~   "
159670|NCT01476137|"~     The purpose of this study is to determine whether the MEK inhibitor and the AKT inhibitor can~     be given in combination and if the combination is effective treatment for patients with solid~     tumors, including breast cancer and endometrial cancer, and for patients with multiple~     myeloma.~   "
159671|NCT01476124|"~     This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or~     gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn~     alone and in combination as well as the tolerability of morphine administered with GEn. The~     dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be~     administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a~     controlled release formulation of morphine will be given. Blood samples for evaluation of~     gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic effect~     of co-administering both treatments will be assessed using visual analog scales for~     somnolence/sedation, dizziness and nausea.~   "
159672|NCT01476111|"~     This study will examine specific biomarkers in primary invasive breast cancer and explore~     their correlation with patient outcome following standard neoadjuvant treatment.~   "
159673|NCT01476098|"~     This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled~     capsaicin challenge~   "
159674|NCT01476085|"~     This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid~     ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in~     patients with Non Hodgkin's Lymphoma.~   "
159675|NCT01476072|"~     An MRI study to develop a reliable methodology for 31P MRS ischaemic exercise in order to~     obtain a consistent standard of measurement of muscle metabolism while maintaining an~     acceptable level of subject comfort and use optimised method to measure and compare~     metabolism in the biceps and quadriceps of patients with COPD-related myopathy and control~     subjects~   "
159678|NCT01476033|"~     The investigators investigate the impact of an encapsulated fruit, berry and vegetable juice~     powder concentrate on oxidative stress, inflammation and blood flow before and post exercise~     in overweight, middle-aged, women.~      Main hypotheses (H1):~        -  The nutraceutical has an impact on oxidative stress reduction.~        -  The nutraceutical has an impact on inflammation.~        -  The nutraceutical has an impact on blood flow and microcirculation.~        -  Walking exercise for 30 minutes has an impact on oxidative stress- and inflammation~          markers.~        -  Walking exercise for 30 minutes has an impact on blood flow and microcirculation~        -  The combination of nutraceutical supplementation + walking exercise for 30 minutes has~          an impact on oxidative stress- and inflammation markers, and on blood~          flow/microcirculation.~   "
159679|NCT01476020|"~     The ITALIC PLUS Trial was designed with the objective of extending to other countries the~     enrollment of patients into the ITALIC trial initially conducted in France, in order to~     achieve statistical significance by pooling the data of both trials.~   "
159680|NCT01476007|"~     Objective: To determine the effectiveness of oral versus intramuscular Cobalamin (vitamin~     B12) by restore cobalamin parameter in blood at 8, 26 and 52 weeks in ≥ 65 aged patients with~     Cobalamin Deficiency.~      Design: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary~     healthcare setting (Madrid Region).~      Participants: ≥ 65 aged patients with Cobalamin Deficiency. Patients give inform consent.~     Number of patients: 320 (160 each arm). Assignment: randomized simple (automatic system).~      Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary outcome~     variables: Adverse events. Adherence measurement of treatment. Health related quality of life~     questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables: Gender. Age. Live~     alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and physical~     examination) and blood parameters. Drugs consume.~      Causes of all losses and withdrawals. Number of patients (age and gender) who declined to~     participate.~      All data (excluding patient identification data) will be record in an electronic database.~      Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular.~      Analysis: Descriptive analysis (screening phase). Baseline comparison of the two intervention~     groups. Effect of cobalamin (main outcome variable). Security. Quality of life. Adherence~     measurement of treatment.~   "
159681|NCT01475994|"~     This is a mono-center, randomized, double-blind, placebo-controlled, parallel-group study to~     assess the effect of challenges with dactylis glomerata pollen in an environmental challenge~     chamber on dermal symptoms in patients suffering from atopic dermatitis.~      After each challenge session and on Day 3, Day 4, and Day 5 blood samples will be taken for~     biomarker assessments. The severity of atopic dermatitis will be rated with the SCORing~     Atopic Dermatitis (SCORAD), with the objective SCORAD and with the assessment of itch and~     sleeplessness referring to the past 24 hours by a blinded observer (trained dermatologist) on~     each day including baseline assessments.~   "
159682|NCT01475981|"~     The purpose of this study was to determine the safety, tolerability and pharmacokinetics of~     ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy~     male subjects.~   "
159683|NCT01475968|"~     The purpose of this study is to examine the acute health effects of concentrated ambient~     ultrafine (UF) particulate matter (PM) exposure in patients with metabolic syndrome. Without~     lifestyle changes or medical intervention these patients are at considerable risk for~     developing diabetes and cardiovascular disease. Subjects (25-70) were exposed to both UF PM~     and filtered air for 2hr (at least 2 week interval), physiologic endpoints were measure pre-,~     post-, and 20hr post-exposure. Our hypothesis is that PM exposure in this population will~     result in changes in vascular and endothelial response as assessed by flow-mediated~     dilatation of the brachial artery and various heart rate variability and blood endpoints.~     This study and similar studies of susceptible populations are needed to provide the EPA with~     information regarding the health risks associated with ambient levels of UF PM.~   "
159684|NCT01475955|"~     The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and~     effective in the treatment of actinic keratosis when applied to broad areas on the face and~     scalp for 1, 2 and 3 hours.~   "
159685|NCT01475942|"~     The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile~     levels of elderly subjects.~   "
159686|NCT01475929|"~     The purpose of this study is to analyse the effect of probiotic supplement on symptoms of~     irritable bowel syndrome.~   "
159687|NCT01475916|"~     Asthma is the most common chronic disease in childhood [1]. The advantage of an educational~     program in a global strategy of care has been established in asthma (decrease of nocturnal~     asthma, absence from work and school) [2, 3]. Therapeutic education of the patient permits~     the reduction of the rate of hospitalization, of the rate of emergencies visits and~     non-programmed visits. [3].~      The WHO defines quality of life as an individual's perception of its place in existence, in~     the context of culture and value system in which he lives, in relation to its objectives,~     expectations, standards and concerns [4]. The basic point of this concept is the notion of~     perception, emphasizing the perspective of the person. It is a broad concept affected in a~     complex way by the subject's physical health, psychological state, level of independence,~     social relationships, and its relations with its environment. In the field of health,~     analyzing the quality of life includes objective aspects (living conditions, functional~     health) and subjective aspects (satisfaction, happiness, well-being) that allow to understand~     the situation of people in whole.~      As defined by the WHO-Europe report published in 1996 [5], the therapeutic education aims to~     help patients acquire or maintain the competencies they need to best manage their lives with~     a chronic disease.~      It is entirely part of the management of the patient. It includes organized activities~     designed to make patients aware and informed of their disease, of care organization and~     hospital procedures, and the behaviors related to health and disease. This is to help them~     and their families understand their illness and treatment, to work together and to gain~     autonomy from their disease in order to help maintain and improve their quality of life [6].~      However, studies demonstrating the effectiveness of therapeutic patient education are still~     very few, especially in children. The need for prospective studies including the evaluation~     of the impact on quality of life was highlighted in a recent Cochrane meta-analysis [7]. It~     seems interesting for the authors to assess the improvement of the quality of life after~     educational sessions in children at school-age.~   "
159699|NCT01475760|"~     The purpose of this study is to determine the efficacy of chitosan chewing gum (K2CG) in~     reducing serum phosphorus in subjects with chronic kidney disease.~   "
159752|NCT01475071|"~     The main objective of this study is to compare efficacy and safety of Metvix® natural~     daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with~     Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).~   "
159753|NCT01475058|"~     This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor~     T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in patients~     who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B~     cell malignancy.~   "
159688|NCT01475903|"~     Bariatric surgery is now recognized as a procedure of choice for the treatment of morbid~     obesity, resulting in long-term effectiveness on weight loss and comorbidities. The two types~     of procedures, most often performed in Europe, are adjustable gastric banding (AGB), a purely~     restrictive reversible procedure, and gastric bypass (GBP), an irreversible procedure, which~     associates restriction and mild malabsorption. Longitudinal sleeve gastrectomy (LSG) is~     another bariatric procedure which tends to develop quickly. More recent, this technique is~     recognized in France by the High Authority of Health since 2008, consisting of fundus and~     greater curvature resection, removing 75 % the gastric volume, leaving a narrow gastric tube~     or sleeve.~      Although malabsorption does not occur in most bariatric procedures, micronutrient~     deficiencies are possible. GBP is known to induce nutritional and vitamin deficiencies~     concerning iron, calcium, vitamins B12, B9, D and proteins. Restrictive procedures have minor~     effects on normal physiological digestive processes but could lead to vitamin deficiency~     secondary to decreased nutrient intake and a tendency towards avoidance of certain types of~     food due to intolerance. Studies of nutritional complications of bariatric surgery concern~     essentially AGB, GBP and vertical banded gastroplasty (VBG) which is no longer performed in~     France. The nutritional impact of LSG remains to be evaluated. To date, data concerning~     evaluation of nutritional status from patients who underwent LSG are almost non-existent.~     Considering this type of surgical procedure, the investigators expect to observe essentially~     a deficiency in vitamin B12 and iron. Indeed, defined as a purely restrictive intervention,~     LSG consists of gastric fundus resection which is the site of intrinsic factor production,~     itself necessary for vitamin B12 absorption. Moreover, decrease of hydrochloric acid~     production and potential vomiting caused by gastric resection can alter iron absorption.~      In view of the increasing popularity of this surgical technique, assessment of the~     nutritional consequences of longitudinal sleeve gastrectomy seems to be necessary.~   "
159689|NCT01475890|"~     The purpose of this study is to evaluate safety and efficacy of vitamin D supplementation in~     children, adolescents and young adults with Human Immunodeficiency Virus and acquired~     immunodeficiency syndrome (HIV/AIDS). The study is a 12-month randomized, double blind,~     placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on~     evidence from the Vit D Dose Finding Study-IRB 09-007332.~   "
159690|NCT01475877|"~     This study will compare the effect of two topical non-steroidal antiinflammatory agents to~     control pain after photorefractive keratectomy (PRK) eye surgery.~   "
159691|NCT01475864|"~     The current standard of care for bile duct stone are endoscopic sphincterotomy and stone~     extraction. Placement of plastic stents is an option for incomplete biliary stone clearance.~     This study will use the CSEMS in patients with complex biliary stones who failed stone~     extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing~     measure that allows more successful subsequent stone clearance. However, their use in benign~     condition has been limited especially for biliary stone removal. The purpose of this study is~     to determine the feasibility, safety, easy removability, stent-stone formation rate, and~     migration rate of CSEMS for complex biliary stones.~   "
159692|NCT01475851|"~     The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with~     GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response~     to other drugs.~   "
159693|NCT01475838|"~     This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/~     emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative~     to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus~     Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48~     in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety,~     tolerability, and efficacy of the two regimens through 96 weeks of treatment.~   "
159694|NCT01475825|"~     Primary objective:~      Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in~     patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as~     low-density lipoprotein cholesterol (LDL-C) levels ≥200 mg/dL plus the presence of coronary~     heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of~     CHD/risk equivalents (referred to as Cohort 1) compared to placebo. Two different mipomersen~     dosing regimens will be studied: subcutaneous (SC) mipomersen 200 mg once weekly versus~     placebo, and SC mipomersen 70 mg thrice weekly versus placebo.~      Secondary Objectives:~        -  Determine whether there are qualitative differences between the safety profiles of the 2~          dosing regimens and placebo in Cohort 1, patients with HeFH with LDL-C levels ≥160 mg/dL~          and <200 mg/dL plus the presence of CHD/risk equivalents (referred to as Cohort 2), and~          the overall study population~        -  Determine whether there are qualitative differences between the tolerability of the 2~          dosing regimens and placebo in Cohort 1, Cohort 2, and the overall study population~        -  Further characterize the pharmacokinetics (PK) of the 2 dosing regimens in Cohort 1,~          Cohort 2, and the overall study population~        -  Determine whether the 2 mipomersen dosing regimens significantly reduce atherogenic~          lipid levels in Cohort 2 compared to placebo~        -  Obtain additional data regarding ongoing safety and efficacy of mipomersen in patients~          with FH and inadequately controlled LDL-C who complete the primary efficacy assessment~          visit (PET) in the Blinded Treatment Period and continue treatment in Open-Label~          Continuation Period~   "
159695|NCT01475812|"~     Introduction: Chronic obstructive pulmonary disease is a condition characterized by airflow~     limitation usually progressive and associated with inflammatory response of lung noxious~     particles. During a physical activity chronic obstructive pulmonary disease patients may~     develop dynamic pulmonary hyperinflation, increased dyspnea perception and decreased activity~     performance. The investigators hypothesize that some specific activities of daily living~     induce dynamic pulmonary hyperinflation in COPD patients. Objective: To measure dynamic lung~     hyperinflation and its influence in dyspnea perception in moderate and severe chronic~     obstructive pulmonary disease patients after activities of daily living. Methods: The~     investigators measured inspiratory capacity, dyspnea sensation, peripheral oxygen saturation,~     heart rate and respiratory rate in 19 chronic obstructive pulmonary disease (COPD) patients.~     These measurements were taken at rest and after daily living activities (such as going up and~     down a set of stairs, going up and down a ramp and sweeping and mopping a room).~   "
159696|NCT01475799|"~     The purpose of the study is to determine the safety and performance of the Direct Flow~     Medical study valve and delivery procedure.~   "
159697|NCT01475786|"~     The purpose of this study is to determine if VM202 is safe and effective in treating painful~     diabetic neuropathy.~   "
159698|NCT01475773|"~     Is their a association between the objective and subjective severity of a malocclusion,~     quality of life and self-esteem/personality (as modifier between objective/subjective~     severity and quality of life (cfr study Agou et al., 2008) ? A second goal is to compare~     motivation and expectations and the objective and subjective severity of the malocclusion on~     the other hand.~   "
159700|NCT01475747|"~     Systolic Pressure Intervention Trial (SPRINT) is a large scale randomized trial of ~ 9250~     adults aged 50 years or older with high cardiovascular risk sponsored by NIH. The study is~     designed to recruit 45% of the study population with Chronic Kidney Disease (CKD). The trial~     will test the effects of low systolic blood pressure (SBP) goal of < 120 mm Hg versus the~     standard goal of < 140 mm Hg on the primary composite of cardiovascular events and death. One~     of the pre-specified secondary outcome is the progression of kidney disease. In this~     ancillary named SPRINT - Factors affecting Atherosclerosis STudy (FAST), the investigators~     plan to take advantage of the unique opportunities afforded by the parent study to examine~     issues that are of significant public health importance.~      This is an observational study in SPRINT participants. This study will examine~     mechanistically, the factors affecting the progression of atherosclerosis in CKD.~   "
159701|NCT01475734|"~     This is a stepped glucose clamp study designed to investigate the effect of treatment with~     albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in~     subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given~     prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate~     that albiglutide increases insulin secretion and decreases glucagon levels in a~     glucose-dependent manner.~   "
159702|NCT01475721|"~     The purpose of this study is to assess whether the risk of serious asthma-related events~     (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and~     adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol~     combination is the same as those taking inhaled fluticasone propionate alone.~      ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.~   "
159703|NCT01475708|"~     The investigators will compare the outcome of three groups of erythema migrans patients~     treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and~     with severe symptoms that require lumbar puncture.~   "
159704|NCT01475695|"~     Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose~     of 14C-GSK2251052 under fasted conditions. Blood, urine and fecal samples will be collected~     for a minimum of 14 days following study drug administration. Safety and tolerability will be~     monitored throughout the study. A follow-up visit will occur 7-14 days after study drug~     administration.~   "
159705|NCT01475682|"~     Subjects with Obstructive Sleep Apnea (OSA) are at increased risk of developing~     cardiometabolic complications, and effective long-term nCPAP treatment significantly reduces~     the risk of cardiovascular morbidity and mortality.~   "
159706|NCT01475669|"~     The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can~     reduce the amount of donor blood products needed during complex cardiovascular surgery, and~     that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo~     infusion during surgery. This will be in addition to the standard treatment, which is donor~     blood or blood products. Placebo does not contain any effective medicine.~      The study is randomised. This means that the likelihood that subjects will get FCH or placebo~     is 50%. To make the comparison between FCH and placebo as fair as possible, the study is~     double blind. This means that neither the subjects nor the study doctor will know if FCH or~     placebo is administered. If necessary, the study doctor can find out which treatment the~     subjects are receiving.~   "
159707|NCT01475656|"~     The purpose of this research study is to learn how well the medication levetiracetam (Keppra)~     works to treat seizures in full term and premature babies. Levetiracetam is commonly used in~     babies with seizures at Cincinnati Children's Hospital, especially if the seizures have not~     been stopped by other medicines. The Food and Drug Administration (FDA) has approved the use~     of levetiracetam for older children (over the age of 4) but not for infants. Even though it~     is not FDA approved for this age group, doctors at Cincinnati Children's use the medicine as~     a second drug in babies whose seizures are not stopped by phenobarbital. Some doctors are~     concerned that phenobarbital is not the best medicine to treat seizures in babies, so~     researchers are trying to study other medicines.~      In this study, the investigators are looking at how well levetiracetam stops or slows down~     seizures in babies. The investigators are also studying the blood levels of levetiracetam to~     learn more about how the medicine is processed by the body and what level of medicine in the~     body works to stop seizures. The investigators are checking labs before and after giving the~     dose to make sure the medication does not cause any changes in blood counts, kidney function,~     or liver function. The investigators are following all of the babies in the study after~     hospital discharge to see if the parents notice any side effects of the medication. Babies in~     the study will come back to the High Risk Follow Up Clinic at Cincinnati Children's at 6~     months of age for a visit with a neurologist and a neonatologist and developmental testing.~   "
159708|NCT01475643|"~     The objective of this study is to compare the efficacy and safety for the treatment of~     postoperative inflammation following ocular surgery for childhood cataract.~   "
159709|NCT01475630|"~     The aim of the present study was to investigate the effect of Physical Therapy (PT) on pain~     and mandibular function in patients with anterior disc displacement without reduction (ADD-R)~     or closed lock of the TMJ and this in a randomized controlled trial design.~   "
159710|NCT01475617|"~     Approximately 33% of the US adult population can be classified as obese based on body mass~     index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed~     every year for the treatment of clinically severe obesity. Roux-en-Y gastric bypass (RYGB)~     is the most common bariatric procedure performed in the United States and has both~     restrictive and malabsorptive components. Despite the success of this procedure in creating~     long lasting weight loss, vitamin and iron deficiencies are common and can lead to~     significant morbidity if not appropriately addressed. Despite the American Association of~     Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic &~     Bariatric Surgery Medical Guidelines that include vitamin and mineral supplementation~     recommendations, there has been very little prospective research conducted to assess the~     efficacy and compliance of these micronutrient interventions.~      This prospective randomized controlled clinical study will evaluate the efficacy of a novel~     vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative~     bariatric patients.~   "
159711|NCT01475604|"~     The purpose of this study is to determine the effectiveness of pulsed radio frequency (PRF),~     a type of electromagnetic field treatment with the Ivivi Torino II for reducing~     post-operative narcotic use in patients recovering from Total Knee Arthroplasty.~   "
159712|NCT01475591|"~     The aim is to evaluate effects of early individually tailored web-based multimodal~     rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary~     health care. The aim is also to study if this early web-based pain rehabilitation program is~     more cost-effective than only multimodal rehabilitation. Randomization will be done at each~     primary health care centre after screening to 1) Multimodal pain rehabilitation with~     web-based education and coaching support or 2) multimodal pain rehabilitation. The~     investigators suggest a clear rehabilitation chain where a web-based program is~     developed,evaluated and ready to implement if it shows positive effects on work-ability~     and/or is cost-effective. The research and implementation will be performed in a close~     cooperation with Luleå University of Technology.~   "
159713|NCT01475578|"~     The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on~     clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study~     structure planned in this project, the dosage and study structure of phase III study can be~     confirmed.~   "
159714|NCT01475565|"~     The polycystic ovary syndrome (PCOS) affects about 10% of reproductive-age women. Women with~     PCOS are at a higher risk of gestational diabetes, which may lead to more pregnancy~     complications. It is unknown if there are factors that may predict which women are more at~     risk.~      The goal of this study is to evaluate the risk factors of gestational diabetes, such as~     dietary and physical activity factors, race, and how the body handles its own hormones during~     pregnancy. Our long term goal is to contribute in finding ways to successfully prevent~     gestational diabetes.~   "
159715|NCT01475552|"~     The researchers aimed to investigate the effect of point-of-care platelet function assay on~     the periprocedural cardiac enzyme elevation in patients with diabetes mellitus.~      All patients who are supposed to undergo coronary angiography were loaded with clopidogrel~     (300mg) and aspirin (300mg) at D-1. If patients were determined to implant coronary stent~     after diagnostic coronary angiography, their platelet function is assayed with Verifynow-ADP~     (Accumetrics). If patients have >270 unit in the assay, they are randomized to abciximab or~     control group. After successful stent implantation, cardiac enzymes (CK-MB, Troponin-I) are~     followed at 8hr, 16hr and 24hr. Clinical outcomes including bleeding complications are~     assessed at 1 month.~   "
159716|NCT01475539|"~     The purpose of this study is to generate data to support the registration extension of IMOVAX~     Polio to be used in a sequential vaccination.~      Primary objective:~        -  To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral~          Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2)~          poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of~          seroprotection rate 28 to 42 days after the third dose of the primary vaccination~          series.~      Secondary objectives:~        -  To evaluate the safety profile of the investigational vaccines after each administration~          in each group.~        -  To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3)~          before the first dose and 28 to 42 days after the third primary series dose of vaccine~          in each group.~        -  To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and~          3) after the third primary series dose administration, at 18 months of age in each~          group.~   "
159717|NCT01475526|"~     El Valor de Nuestra Salud [The Value of Our Health] is a 5-year study (2010-2014) involving~     grocery stores in San Diego County funded by the National Cancer Institute. The purpose of~     the study is to determine whether an in-store program can promote healthy foods through~     grocery stores. Sixteen stores in San Diego County will participate in El Valor de Nuestra~     Salud. The stores that participate in this study will be randomly assigned to either the~     intervention (program and evaluation) or control (evaluation only) group. We will test~     various strategies to promote healthy food shopping among customers of small-to-medium size~     Latino/Hispanic grocery stores. These strategies include changes to the store environment,~     food marketing efforts, and training of sales associates. Our evaluation protocol will~     determine whether the project is successful at improving aspects of the store and the~     employees, as well as whether customers shop for and eat healthier food products. The primary~     aim of the study is to evaluate the impact of the El Valor de Nuestra Salud intervention on~     consumption of fruits and vegetables among store customers.~   "
159718|NCT01475513|"~     Birth control pills are the most commonly used method of birth control. The purpose of this~     research study is to examine whether birth control pills change heart disease risk and how~     the body handles blood sugar when given to different women.~   "
159719|NCT01475500|"~     This screening study will address the lack of molecular strategies for the early detection of~     lung cancer and integrate those with epidemiological and imaging strategies.~      The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular~     analysis of biological specimens including those from bronchoscopy (bronchial brushings and~     biopsies) may contribute to the refinement of high-risk populations and allow an earlier~     clinical diagnosis.~      The goal of the investigators study is to provide screening for lung cancer in a high-risk~     population. In this prospective cohort it will be tested whether repeated measure of~     biomarkers of risk allows early detection of lung cancer.~   "
159720|NCT01475487|"~     Inability to provide oxygen to the patient remains the most fearful anesthesia-related~     mishap. Cricothyrotomy (CT) is an infrequently performed but life saving procedure for an~     anesthesiologist, who is encountered with this situation. The current method of~     cricothyrotomy relies on digital palpation (DP). Several patient populations, including~     morbidly obese, short neck, radiation to and previous neck surgeries, have difficult~     landmarks for this procedure. Ultrasound (US) technology has been used in the past to~     visualize landmarks for cricothyrotomy, but there is no study which has examined the role of~     ultrasound in patients who have obscure landmarks. There is no data related to the~     performance of ultrasound guided cricothyrotomy in these patients. In this study, we aimed to~     determine the outcomes of CT performed on human cadavers using US-guidance, compared to~     conventional DP, of anatomical landmarks. In particularly, complication rates, failure to~     cannulate, correct placement of the device and insertion time of CT were assessed.~   "
159721|NCT01475474|"~     The purpose of this study is to determine whether the use of the Renew Insert is effective,~     tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.~   "
159722|NCT01475461|"~     B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2~     diabetes~   "
159724|NCT01475435|"~     Abstract Diabetes mellitus and periodontal diseases are both chronic inflammatory disorders~     that have a major impact on the health and well being of millions of individuals worldwide.~     Periodontal diseases are among the most common diseases in humans, therefore, if the presence~     of periodontal diseases plays any role in overall systemic health, the public health impact~     may be substantial. An important factor that can be involved in the progression of the~     periodontal disease is the production of Reactive Oxygen Species (ROS). The imbalance between~     oxidative stress induced by ROS and the concentrations (or activity) of the antioxidant may~     result in tissue damage. The ROS induce the activity of lipid peroxidation-Tbars,~     myeloperoxidase (MPO), peroxidase and arginase, whose mechanisms reflect the severity of the~     periodontal disease and it may offer the basis for a patient specific diagnostic test for~     periodontitis and could have therapeutic significance. The aim of this study is to~     investigate quantitatively the levels of oxidative stress markers (Myeloperoxidase,~     Peroxidase, Lipid Peroxidation and Arginase) in saliva and in gingival crevicular fluid (GCF)~     of diabetes type 2 subjects with generalized chronic periodontitis and periodontally healthy~     individuals, and systematically healthy individuals with generalized chronic periodontitis~     and periodontally healthy individuals, before and after periodontal treatment. Unstimulated~     whole saliva will be collected for 5 min as well as GCF of 25 diabetes type 2 with~     generalized chronic periodontitis, 25 diabetes type 2 periodontally healthy individuals as~     controls, 25 systematically healthy individuals with generalized chronic periodontitis and 25~     periodontally healthy individuals before and after treatment. The following clinical~     parameters will be evaluated: probing pocket depth, probing attachment level, plaque index~     and the gingival index. The activity of stress markers in saliva and GFC will be analyzed by~     spectrophotometry. Adequate statistical analysis will be carried out with a p-value set at p~     < 0.05.~   "
159725|NCT01475422|"~     The self-monitoring of capillary blood glucose is part of the package of interventions in~     diabetes mellitus and an effective therapeutic strategy for the adequate control of the~     disease; and the continuing education of people with DM is recognized as one of the goals to~     delay the complications arising from chronic disease and alleviate the symptoms of~     hypoglycemia and hyperglycemia.~   "
159726|NCT01475409|"~     The screening for latent tuberculosis infection (LTBI) prior to the onset of anti-tumor~     necrosis factor therapy, as well as a watchful monitoring during the treatment, is strongly~     recommended. Tuberculin skin test (TST), universally used for this purpose, lacks sensitivity~     and specificity. The novel screening tools, including QuantiFERON-TB Gold In-Tube (QFT-GIT),~     have shown a higher specificity compared to TST, but their feasibility in the setting of~     immunosuppression remains unclear. Aims of this study were to investigate the performance of~     QFT-GIT and its agreement with TST in patients awaiting anti-tumor necrosis factor (TNF)~     therapy, and to evaluate the usefulness of serial QFT-GIT during the treatment with biologics~     to assess whether dynamic changes in interferon (IFN)-gamma levels may be helpful in~     identifying reactivation of LTBI or cases of newly acquired tuberculosis.~   "
159727|NCT01475396|"~     Physical activity is thought to increase overall body functions and to decrease~     cardiovascular and stroke risk factors. Now the question arose, wether enhanced exercise~     could also exert positive influence on cognition in the aging brain. Therefore, 50 to 80~     years old healthy subjects take part in a prospective study with regular sports activity~     during 6 months. Cognitive functions are detected with sensitive neuropsychological outcome~     measures, further investigations include MRT of the head, lactat- and other physical measures~     as well as detailed serum profiles. As a hypothesis, enhanced physical activity is suggested~     to predict better cognitive performance.~   "
159728|NCT01475383|"~     The purpose of this study is to evaluate the safety and efficacy of an investigational~     compound designated PF-03654746 compared to placebo in the treatment of adults with~     Tourette's Syndrome. The study will also explore the pharmacokinetics of PF-03654746 in~     adults with Tourette's Syndrome.~   "
159729|NCT01475370|"~     The purpose of this study is to assess the safety of OCV-501 in patients with AML who~     completed the Study 311-10-001 and were judged that there was no relapse by any inspections~     in the end of the study.~   "
159730|NCT01475357|"~     Postnatal intestinal function in cardiac infants. The overall goal of this proposal is to~     address a widespread health problem in the pediatric cardiac infant population - poor~     postnatal growth - through a collaborative effort between pediatric cardiology,~     cardiothoracic surgery, neonatology, microbiology, and immunology. The hypothesis is that~     term neonates with complex congenital heart disease (CHD) who receive trophic breastmilk~     feeds in the pre-operative period will show improved gut function than neonates who were~     strictly NPO (nothing by mouth) in the pre-operative period.~   "
159731|NCT01475344|"~     Severe traumatized patients with visible significant bleeding and/or with clinical signs of~     internal significant bleeding treated by an emergency doctor of the helicopter service or the~     ground team will be enrolled in the study (inclusion- and exclusion criteria: see above). If~     a patient meets the inclusion criteria and is recruited for the study, FGTW or placebo~     administrated over 5 min/vial:~      Body Weight: < 30 kg / 30-60 kg / 60 - 90 kg / > 90 kg~      No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml)~      Fibrinogen (if applicable): 1.5 g / 3 g / 4.5 g / 6 g~   "
159732|NCT01475331|"~     The purpose of this study is to evaluate the efficacy of a chemotherapeutic cocktail with or~     without prior ethanol lavage for ablation of premalignant pancreatic cysts using endoscopic~     ultrasound-guided fine needle injection (EUS-FNI) for agent delivery.~   "
159733|NCT01475318|"~     By using the combination of mifepristone (anti-progestin), misoprostol (progstanglandin which~     stimulates uterine contraction), and letrozole (aromatise inhibitor which reduces estrogen~     production), the abortion process will be more effective.~   "
159734|NCT01475305|"~     The primary objective is to evaluate the suitability of the challenge model in measuring the~     efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in~     the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.~   "
159735|NCT01475292|"~     RV568 is being developed as a possible treatment of diseases such as smoking related lung~     disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma.~      The main purpose of this study is to examine the safety of RV568 in COPD patients. Two dose~     strengths of RV568 and a placebo will be tested in this study, which will be given by~     inhaling a liquid suspension from a nebuliser once a day for 2 weeks.~   "
159736|NCT01475279|"~     The purpose of this study is to evaluate the potential effect of Dantonic on the steady-state~     pharmacodynamics and pharmacokinetic of warfarin in healthy subjects and safety of the~     co-administration of Dantonic and warfarin.~   "
159737|NCT01475266|"~     The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle~     invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were~     randomized into either an EO9 or placebo group after TURBT.~   "
159738|NCT01475253|"~     The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system,~     is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into~     the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via~     cystoscopy.~   "
159739|NCT01475240|"~     Use of some protease inhibitors is associated with elevations of a blood pigment called~     bilirubin. This may occasionally lead to yellowing of the eyes (scleral icterus) or jaundice,~     but in the general population bilirubin elevations have been shown to have antioxidant and~     anti-inflammatory properties that could be associated with reduced risk of cardiovascular or~     other disease events.~      Inflammation may also be relevant to neurocognitive impairment in HIV (Human Immunodeficiency~     Virus) infection hence elevations of bilirubin may also be protective against neurocognitive~     impairment.~      The purpose of this study is to evaluate the impact of hyperbilirubinemia (HBR) on risk of~     heart and renal diseases, and cognitive function.~   "
159740|NCT01475227|"~     The study is being conducted as the most common side effect of the HIV drug atazanavir (taken~     with ritonavir) is hyperbilirubinaemia. Bilirubin is a normal waste product from the body and~     gets broken down in the liver so it can leave the body through the gut. Atazanavir slows the~     breakdown of this chemical, which can cause jaundice (yellowing of the skin) and/or scleral~     icterus (yellowing of the eyes). This is completely harmless; in fact up to 1 in 10 of the UK~     population have an inherited condition that causes the same yellowing. However, some patients~     don't like this side effect and it is the commonest reason for switching off the drug.~      A study in people with Gilberts syndrome (the inherited condition that causes the same~     changes in the chemical bilirubin) showed that a mineral supplement (zinc sulphate) reduced~     the levels of bilirubin in the blood. The aim of this study is to see if using zinc~     supplements can achieve the same effect in patients with high bilirubin due to atazanavir~     use.~   "
159741|NCT01475214|"~     With aging, men and women develop a mild and progressive metabolic acidosis. This occurs as a~     result of declining renal function and ingestion of acid-producing diets. There is extensive~     evidence that severe metabolic acidosis causes bone and muscle loss, but the impact of the~     chronic, mild acidosis on bone and muscle in older individuals has not been established. In a~     recent study, administration of a single dose of bicarbonate daily for 3 months significantly~     reduced urinary excretion of N-telopeptide (NTX), a marker of bone resorption and urinary~     nitrogen, a marker of muscle wasting and improved muscle performance in the women but not the~     men. These and other data support a potential role for bicarbonate as a means of reducing the~     musculoskeletal declines that lead to extensive morbidity and mortality in the elderly.~     Before proceeding to a long-term bicarbonate intervention study, however, it is important to~     identify the dose of bicarbonate most likely to be optimal and to characterize the subjects~     who benefit most from it. This double blind, placebo controlled, dose-finding study will~     evaluate the effects of placebo and two doses of bicarbonate on urinary NTX and nitrogen~     excretion and on lower extremity performance over a 3 month period in 138 men and 138 women,~     age 60 and older. Changes in urinary excretion of NTX and nitrogen and in selected measures~     of lower extremity performance will be compared across the three groups. The safety and~     tolerability of the interventions will also be evaluated. This investigation should provide~     needed information on the appropriate dosing regimen for men and women and on the study~     population that should be enrolled in a future bicarbonate intervention trial to assess the~     long-term effects of this simple, low cost intervention on important clinical outcomes~     including rates of loss in bone and muscle mass, falls, and fractures.~   "
159742|NCT01475201|"~     Many people with diabetes and/or high blood pressure (hypertension) are not very active. When~     people are more active, they can reduce the chances of having a heart attack or stroke.~     Walking more is a cheap and effective way to be more active and to lower the risk of heart~     attacks and strokes. The problem is that many people do not walk enough! The investigators~     will study if people with diabetes and/or hypertension walk more when the doctor gives them a~     prescription with the number of steps they should be walking every day. The investigators~     will compare this group, called 'active', to another group, called 'control', in which~     doctors and their patients do what they usually do, over a period of one year.~      The investigators will measure the number of steps the investigators walk everyday with a~     step counter or pedometer. In the step count prescription group, the doctors will give to the~     'active' group a pedometer, a step count record book, and step count prescriptions. The~     overall goal is to gradually increase daily steps. The speed of the increase in step count~     will be slower for less active people. At each visit the doctor will look at the step count~     record book. The doctor will then give a new step count prescription to the patients.~     Patients of the two groups will see their doctor about four times during the year, which is~     how often they usually see their doctor. At the end of one year, the investigators will see~     the difference in the hardness of the arteries between the 'active' and the 'control' groups,~     using simple and safe measurements, similar to ultrasound in pregnant ladies. People with~     hard arteries are more likely to have a heart attack or stroke.~      The investigators suspect that patients who get the step count prescriptions will walk more~     and their arteries will be less hard than the control group. Our study will help find out if~     this is true. In that case, doctors should take the time to prescribe steps for all their~     patients with diabetes and/or hypertension.~   "
159743|NCT01475188|"~     The purpose of this study is to determine whether specific subcutaneous immunotherapy affects~     fractions of regulatory T lymphocytes and histamine H2 receptor expression and ZAP70 in~     regulatory T lymphocytes.~   "
159744|NCT01475175|"~     The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective,~     multi-center, non-randomized investigational study designed to compare indices of cardiac~     function at device settings optimized using the investigational Adaptive CRT (aCRT) algorithm~     versus nominal programming. The comparison will be performed during rest, atrial pacing and~     sub-maximal exercise. AdOPT CRT is a sub study of the Adaptive CRT Study (NTC00980057) being~     conducted in Europe.~   "
159745|NCT01475162|"~     This trial designed to evaluate the toxicity and efficacy of tocilizumab in the treatment of~     steroid refractory acute Graft versus host disease (GVHD).~   "
159746|NCT01475149|"~     This 12 week study will observe patients with and without systemic lupus erythematosus who~     have persistent antiphospholipid antibodies in the blood who are starting a medicine called~     hydroxychloroquine. It will measure if these patients have a change in a blood test called~     the annexin A5 resistance assay over that 12 week period.~   "
159747|NCT01475136|"~     This study will explore how liver impairment effects blood levels of LY2140023 (a prodrug)~     and its active metabolite LY404039.~   "
159748|NCT01475123|"~     Nicorandil is potentially effective to prevent cardiovascular events in patients with~     coronary artery disease (CAD) receiving hemodialysis. The purpose of this study is to~     prospectively investigate whether nicorandil is effective in reducing the incidence of~     cardiovascular events in patients with CAD on hemodialysis.~   "
159749|NCT01475110|"~     The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study~     of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment~     will include all patients who started Nilotinib between January 2005 and December 2012.~     Patients will be followed for 4 years since treatment start. After this time, survival data,~     disease status and treatment will be recorded at 6-months-interval. This study will help the~     definition of guidelines for a proper management of Nilotinib in any-phase CML patients.~   "
159750|NCT01475097|"~     The purpose of this study is to evaluate and compare overall patient comfort profile between~     an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media~     (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.~   "
159751|NCT01475084|"~     The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid~     thoracoscopy.~   "
159754|NCT01475045|"~     The aim of the study is to compare patients' satisfaction from the use of three different~     inhalation devices by using the FSI-10 questionnaire~   "
159755|NCT01475032|"~     The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler~     (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP)~     and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung~     functions in asthmatic children patients.~   "
159756|NCT01475019|"~     The first aim of the investigators study, was to investigate the combined effect of~     diet,physical exercise and orlistat, for 24 weeks, on serum Anti-Müllerian Hormone (AMH)~     levels in obese women with polycystic ovary syndrome (PCOS) and in obese controls.~      The other aim of the investigators study, was to examine the effect of hypocaloric~     diet,physical exercise plus sibutramine on serum AMH levels, body composition, hormonal and~     metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS).~   "
159757|NCT01475006|"~     This is an open-label, sequential dose exploration study of single agent AMG 595 administered~     in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA).~     The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of~     AMG 595, and also to evaluate the objective response rate in subjects receiving AMG 595. This~     study will be conducted in two parts. Part 1 will explore doses of AMG 595 in subjects with~     recurrent GBM and/or AA. Part 2 (dose expansion) will examine the MTD established in Part 1~     in subjects with recurrent GBM.~   "
159758|NCT01474993|"~     The primary objectives of this study are to answer whether there is evidence of measurable~     effects on social responsiveness (primary outcome) and other behavioral symptoms after~     treatment of autistic male adolescents and adults with orally administered sulforaphane-rich~     Broccoli Sprout Extract (efficacy). The secondary objectives of this study are to answer~     whether treatment of male adolescents and adults with autism using orally administered~     sulforaphane-rich Broccoli Sprout Extract within a specified dose range is safe (toxicity);~     treatment with sulforaphane-rich Broccoli Sprout Extract is well tolerated (side effects and~     adverse events); key cellular biomarkers support the hypothesized mechanisms (proof of~     principle).~   "
159759|NCT01474980|"~     This is a retrospective study that follows the clinical evolution, the pregnancy and the~     post-partum perioad of female patients with Congenital Myasthenic Syndrome.~   "
159760|NCT01474967|"~     Polycystic ovarian syndrome (PCOS) is the most common cause of anovulatory infertility and~     causes menstrual disruption in 6.6-6.8% of women in reproductive age and is characterized by~     insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. The gaol of this~     study was to assess the effects of metformin on menstrual disorders and lipid profile in~     women with PCOS in bandarabbas.~   "
159761|NCT01474954|"~     This is a single-site substudy, Investigation of the Effect of Cenicriviroc (CVC) plus~     Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors, open to all patients~     enrolled in the primary study, A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of~     100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With~     Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With~     Only CCR5-Tropic Virus, in the San Francisco Bay area to evaluate changes in brachial flow~     mediated dilation in patients in one of three treatment groups: 1. Cenicriviroc (CVC) at~     100mg (2 tablets, 50mg each) QD + CVC matching placebo (2 tablets) QD + Efavirenz (EFV)~     matching placebo (1 capsule) QHS + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1~     tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS~     + FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS~     + FTC/TDF (1 tablet) QD. The substudy will run for the duration of the primary study. 50~     patients of the 150 total enrolled in the primary study will be referred to and enrolled in~     the cardiovascular substudy.~      Patients enrolled in the substudy and substudy protocol staff will be blinded to study~     treatment. Data obtained on this substudy will be analyzed in conjunction with laboratory~     data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary~     study.~      The primary study is a randomized, double-blind, double-dummy, 48-week, comparative study in~     approximately 150 HIV-1-infected, treatment-naïve patients with CCR5-tropic virus. Patients~     will be stratified by Screening HIV-1 RNA level (≥100,000 copies/mL versus <100,000~     copies/mL) and randomized 2:2:1 to one of the three treatment groups. Patients will receive~     all medications from the primary study, and thus the primary study site will be responsible~     for any adverse outcomes with the drug.~   "
159762|NCT01474941|"~     The primary purpose of this trial is to evaluate the safety and tolerability,~     pharmacokinetics and pharmacodynamics, of multiple oral doses of PF-04620110 as a~     modified-release formulation.~   "
159763|NCT01474928|"~     In this study, the investigators aim to develop and test the effectiveness of culturally~     appropriate asthma videos and other educational materials based on knowledge from this study~     and the investigators' previous studies. By culturally appropriate materials the~     investigators mean to develop health information (in the format of video and written~     materials) in the community own language and applied the most appealing cultural beliefs and~     practices in the Chinese and Punjabi communities. The investigators also aim to recommend a~     practical framework and to develop a measure of asthma knowledge and health literacy among~     immigrants from the Punjabi and Chinese communities in BC. The investigators' definition of~     health literacy in this study is the capability of a person to navigate and access to~     asthma-related information, as well as to understand, evaluate, and communicate the obtained~     information to improve his/her health status. The investigators' hypothesis is that~     audio-visual based asthma information in a subject's native language would improve a~     patient's knowledge and self-management of asthma in comparison to printed information.~   "
159764|NCT01474915|"~     This study is being done to determine the efficacies of two preventative drug combinations~     for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this~     study is to compare the efficacy of using aprepitant instead of ondansetron in combination~     with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By~     completing this comparison study investigators will determine the most efficacious drug~     combination which will allow us to enhance the overall comfort and satisfaction of~     neurosurgical patients in the immediate postoperative period.~   "
159765|NCT01474902|"~     The CATCH-enoxaparin trial is the natural continuation of the CATCH study. It will capitalize~     on the fact that patients enrolled in the CATCH study will be specifically screened for~     asymptomatic thromboembolism (TEs) in order to answer important clinical questions.~      The investigators propose a randomized controlled trial to address whether, among pediatric~     patients with congenital heart defects (CHD) recovering from cardiovascular surgery and~     diagnosed with an asymptomatic venous TE, the use of enoxaparin results in a net therapeutic~     benefit?~   "
159766|NCT01474889|"~     The Investigator is in the final phase of this study and is searching for a Hypo-AWARE Type 1~     diabetic control group (Group 2). The primary goal for Group 2 in this study; is to~     demonstrate how hormones of Type 1 diabetics should react during hypoglycemic and~     non-hypoglycemic events.~      Enrollment for Group 1 (Hypo-Unaware) and Group 3 (Non-diabetic) is complete.~      This study is designed to determine if real-time continuous glucose monitor (RT-CGM) can~     reverse defective Glucose counter regulation and hypoglycemia unawareness in long standing~     type 1 diabetes.~   "
159767|NCT01474876|"~     This 12-month postmarketing observational study (PMOS) was a prospective, single-arm,~     multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the~     initial baseline visit. The study was conducted to determine the long-term effectiveness of~     treatment with adalimumab in routine clinical use in participants with Ankylosing Spondylitis~     (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.~   "
159768|NCT01474863|"~     This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate~     biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to~     placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis~     is that intravenous L-citrulline will decreased the development or progression of acute lung~     injury in patients with severe sepsis compared to placebo.~   "
159769|NCT01474850|"~     The aim of this study is to examine chest wall volume changes monitored by opto-electronic~     plethysmography during recovery from anesthesia and early postoperative period.~   "
159770|NCT01474837|"~     Exercise as an adjunct to routine treatment may be useful for helping young people recover~     from distressing mental health problems, but they seldom get sufficient support to help them~     to exercise. The reasons for this may be that services cannot agree on the benefits of~     exercise, and the lack of reliable evidence showing the benefits of exercise in young people~     who use mental health services. Compliance with prescribed exercise is generally low, but the~     investigators think that relatively few young people will drop out of our specially designed~     programme. The investigators have found that young 'healthy' people may respond better if~     exercise is matched to their ability. The investigators are not sure if this would work with~     young people with mental health difficulties, so the investigators want to test it. The~     investigators have also found that our enabling exercise plan, with social support and~     motivational coaching, helps people with depression to take part, and not to drop out. The~     aims of our study are to see if exercise matched to their ability, with support in taking~     part, helps young people recover from distressing mental health difficulties. The~     investigators also want to ask young people how they feel about exercise as a part of their~     recovery. The investigators want to see if motivational coaching can help ongoing~     participation in exercise, and the investigators want to follow up the young people after six~     months to see if they are still doing exercise. The investigators believe that this study is~     important because it will help young people feel better about themselves, and improve their~     quality of life. This is an important national public health goal and should enable young~     people to grow into healthy adults, and maintain their health throughout adulthood. If our~     study is successful, the investigators believe that it has the potential to change the way in~     which mental health services deliver care to young people. If the investigators can help~     young people feel better about themselves, and improve their general health and well being~     through exercise, the investigators may reduce their reliance on mental health services.~      Research hypotheses A tailored exercise intervention will lead to significantly improved~     mental health outcomes and reduced exercise attrition rates in young people with depression.~   "
159771|NCT01474824|"~     Measurement of how much blood the heart pumps may be useful in guiding how much intravenous~     fluid to give patients during surgery. The current monitors either require special drips~     (arterial and/or central lines) or a probe inserted into the oesophagus (food pipe) which may~     limit their use. Newer monitors are available which are completely non-invasive and seem to~     work well in younger patients. Patients with hip fracture are elderly and frail. The~     investigators wish to see whether the newer non-invasive monitor works well enough compared~     to the current monitors in this group of patients. If it does this may allow more of these~     patients to be monitored in this way.~   "
159772|NCT01474811|"~     The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients~     undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic~     and community practices.~   "
159773|NCT01474798|"~     This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in~     subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via~     subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of~     3 injections. Study drug will be administered under close observation in a facility equipped~     to handle medical emergencies. Subjects will not be discharged from the facility until at~     least 1 hour following the injection or 1 hour after their vital signs have stabilized.~     Safety will be assessed by pre- and post-treatment serial measurements of vital signs,~     clinical laboratory assessments, and the recording of adverse clinical events.~   "
159774|NCT01474785|"~     The purpose of this study is to determine if interruption in gastric-adipose tissue axis~     signaling contributes to early improvements in oxidative stress, insulin sensitivity, and~     inflammation, and to determine if interruption of the stomach in RYGB results in reduction of~     plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin (AG:UAG)~     ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.~   "
159775|NCT01474772|"~     The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy~     (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates~     improvement relative to placebo on the following: reducing DPN pain, reducing pain on~     walking, and providing other benefits associated with daily activities and quality of life.~   "
159776|NCT01474759|"~     The primary aim of this research is to determine the efficacy of two portion-control~     strategies to achieve sustainable dietary and behavior changes and to promote weight loss and~     maintenance. A randomized controlled trial will test two approaches to managing portion~     sizes: one that gives individuals skills and tools to help them make appropriate portion~     choices, and another that focuses on consumption of pre-portioned foods in order to limit~     exposure to large portions in the personal food environment. A third group will receive a~     basic nutritional program to promote weight loss.~      The second aim of the research is to determine the effects of the programs on knowledge and~     consumption of appropriate portions, as assessed by innovative assessment methods and~     multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual~     factors that may influence the response to the portion-control interventions, such as~     psychosocial indicators, blood biomarkers, and measures of adherence to the interventions.~     The expected outcome of the project is that it will lead to the development of specific,~     evidence-based strategies to help control portion sizes in order to manage weight.~   "
159777|NCT01474746|"~     This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2~     years to 5 years 8 months old. The trial is six months long, and each participant will~     receive a series of tests at both the beginning and end of the study. The researchers hope to~     show improvements in language and a decrease in autistic symptoms.~   "
159816|NCT01474239|"~     This randomized, non-comparative study will evaluate the efficacy and safety of Avastin~     (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive~     Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15,~     followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with~     fotemustine serves as a calibration arm and no formal efficacy comparison will be made~     between the two treatment arms. The anticipated time of study treatment is until disease~     progression or unacceptable toxicity.~   "
159778|NCT01474733|"~     1. Briefly describe the purpose of this protocol: This study is designed to evaluate the~          effectiveness of an educational training program on the topic of health literacy for~          Family Medicine residents. The hypothesis being tested is that training residents about~          health literacy will result in improvements in residents' knowledge, skills, and~          attitudes with respect to health literacy.~        2. Briefly summarize how participants are recruited: OHSU Family Medicine Interns attending~          mandatory trainings on the topic of health literacy throughout the three years of the~          residency program will be invited to participate in the study.~        3. Briefly describe the procedures subjects will undergo: Completion of a short~          self-administered anonymous survey before and after a variety of learning sessions on~          the topic of health literacy.~        4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test~          questionnaire and 13-item post-test questionnaire designed to assess individuals'~          knowledge about health literacy, and intended clinical practices with respect to health~          literacy.~        5. If this is a clinical trial using an experimental drug and/or device, or an approved~          drug and/or device used for an unapproved purpose, briefly describe the drug and/or~          device: n/a~        6. Briefly describe how the data will be analyzed to address the purpose of the protocol:~          Demographics and responses to individual items will be reported as frequencies and~          percentages within the sample. We will use a chi-square analysis to stratify responses~          by demographic groups and t-tests to measure possible changes over time~   "
159779|NCT01474720|"~     Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for~     the development of shingles, a painful reactivation of the varicella zoster virus that causes~     chicken pox.~      The investigators propose to study the immune response to commercially available Zostavax~     vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and~     are on mild immunosuppressant medications, and to compare the immune response to that seen in~     healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the~     study are those felt to be safe according to Centers for Disease Control guidelines.~      Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to~     receive a single, standard dose of Zostavax. Blood samples and physical examination will be~     performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants~     will receive active vaccine, there is no placebo group.~   "
159780|NCT01474707|"~     Goal: The main goal of this study is to develop and validate educational materials that aim~     to improve self-management knowledge and practices about COPD among patients in Mandarin and~     Cantonese-speaking communities in the Greater Vancouver Area (GVA).~      Objectives: 1. To assess the current landscape of COPD beliefs, perceptions and practices,~     as well as health literacy as it relates to Chinese Mandarin and Cantonese-speaking patients;~     2. To develop effective partnerships within primary care physicians serving Chinese~     newcomers in the GVA' 3. To conduct focus group sessions with collaborative primary care~     physicians to identify common factors that contribute to under service and access barriers~     among patients in the target communities; 4. To assess the effectiveness of the educational~     materials on patients' beliefs, perceptions, practices, and health literacy related to COPD~     control and self-management; and 5. To improve the capacity of physicians and allied health~     workers in primary care settings in educating patients and their families about~     self-management of COPD.~      The implementation of the project will include the following phases: 1. Build and~     strengthen established partnerships with primary care practices serving newcomers in GVA;~     2. Conduct an environmental scan and needs assessment (literature review, interviews and~     focus groups with community members and key-informants); 3. Development of story scripts,~     video clips and other educational materials, and relevant measurement tools; 4. Application~     of the video clips and other educational materials to test their effectiveness on health~     literacy, beliefs, and knowledge among COPD patients from the target communities; and 5.~     Evaluation of the usefulness of videos and other educational materials, and the project's~     process and outcomes.~   "
159781|NCT01474694|"~     Preoperative image-guided data correlates with the actual intraoperative reality.~     Computer-assisted preoperative planning combined with intraoperative mapping of even very~     small lesions allows for improved accuracy during complete oncological resection / ablation.~     In the short- and long-term this possibly results in better patient outcome.~   "
159782|NCT01474681|"~     This study evaluated the safety and tolerability of using HSC835 in patients with~     hematological malignancies.~   "
159783|NCT01474668|"~     This study will be an open-label, non-randomized, absorption, metabolism, and excretion study~     of [14C]-GDC 0941 administered as an oral dose to 6 healthy male subjects following at least~     a 10-hour fast from food (not including water).~   "
159784|NCT01474655|"~     The purpose of this study is to evaluate the changes in visual acuity, metamorphopsia, and~     thickness of retinal layers after epiretinal membrane removal and to investigate factors~     associated with visual function.~   "
159785|NCT01474642|"~     Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response~     rates, which is most commonly used to treat patients with metastatic, recurrent or locally~     advanced, unresectable squamous cell carcinoma of the esophagus. Because the classical dose~     schedule of this two-drug combination is cisplatin 100 mg/m2 day 1 and 5-FU 1000 mg/m2/day~     continuous infusion for 96-120 hr, prolonged administration time and mucosal toxicity are~     inconvenient to the patients with the aim of palliation. Capecitabine, which is oral prodrug~     of 5-FU and mimic continuously-infused 5-FU, is being investigated in phase I, II and III~     trials for the treatment of gastric, gastroesophageal, and esophageal cancers, primarily in~     the first-line metastatic setting but also in the adjuvant setting. In the investigators~     experience, capecitabine plus cisplatin combination (XP) as a first-line treatment for 45~     patients with advanced or recurrent esophageal squamous cell carcinoma demonstrated a~     promising anti-tumor activity with 57% of response rate and showed tolerable toxicity with~     convenience.~      Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in~     patients with advanced esophageal cancer. A Dutch phase II study demonstrated that paclitaxel~     combination with carboplatin had shown an encouraging confirmed response rate of 59% with 51~     patients with resectable esophageal cancer in neoadjuvant setting. Another Dutch phase II~     study showed 43% of response rate including 4% of CR with 8 months of response duration when~     paclitaxel plus cisplatin administration was given for patients with metastatic esophageal~     cancer. Although recently first-line palliative chemotherapy regimen in esophageal cancer has~     been investigated, many trials have failed to show superiority to 5-FU/cisplatin combination.~     Since the investigators considered that XP or XG (genexol) is more effective and convenient~     chemotherapy regimen than 5-FU/cisplatin, this randomized phase II study was planned to~     compare XP with XG in terms of efficacy and tolerability.~   "
159786|NCT01474629|"~     We investigate the impact of a probiotic-based dietary supplement on oxidative stress and~     endotoxemia before and after strenuous exercise.~      Hypotheses (H1):~        -  Supplementation has an influence on oxidative stress parameters before and post exercise~        -  Supplementation has an influence on parameters of endotoxemia and inflammation before~          and post exercise~        -  Strenuous exercise has an influence on parameters of oxidative stress, inflammation and~          endotoxemia~   "
159787|NCT01474616|"~     Almost 90 percent of residents living in long-term care facilities have some type of mobility~     limitation, which worsens quickly once they move into a long-term care facility. This means~     that they cannot easily walk or move around in their day-to-day lives and this can have~     serious consequences for their general health and well-being. Researchers have shown that~     exercise can help the mobility of even the oldest of adults but elderly residents in~     long-term care facilities still commonly sit or lie in bed for long periods of time, in many~     cases for most of their waking hours. The purpose of this research is to study the effect of~     a simple physical activity on the mobility and quality of life of residents in long-term care~     facilities. Researchers will introduce a sit-to-stand activity to health care aides which~     will become part of their daily routine with residents. The basic sit-to-stand movement is~     already a part of the daily activities that health care aides do with residents.~     Specifically, health care aides will ask residents to repeat the sit-to-stand activity at~     mealtimes, when using the toilet, and on other occasions of daily activity. An important part~     of this research is to find out how well the activity preserves the ability of residents to~     stay mobile and also to examine how this will improve their quality of life in the home. The~     MOVE study will demonstrate whether it is possible to delay the loss of mobility in long-term~     care residents by incorporating the sit-to-stand activity into the regular practice of health~     care aides.~   "
159788|NCT01474603|"~     Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are~     crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous~     study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose~     tissue inflammation in morbidly obese non-diabetic subjects. in this observational study the~     investigators will apply n-3 polyunsaturated fatty acids as addition to a protein-enriched~     diet with low glycemic index to overweight and obese patients with insulin resistance,~     prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy parameters are~     changes from baseline in HbA1c and body weight for for type 2 diabetes and all other~     patients, respectively.~   "
159789|NCT01474590|"~     Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group~     comparison study in subjects with severe acne vulgaris on the face.~   "
159790|NCT01474577|"~     The physician would like to see if nuclear cardiac stress tests can predict cardiac health.~     For example, if a patient has an abnormal stress test, is he or she more likely to have~     cardiac problems in the future?~   "
159791|NCT01474564|"~     The purpose of this study is to collect blood samples and study cancer cells found in these~     blood samples from patients with pancreatic cancer. Prior research has discovered that tumor~     cells can be collected from the blood of patients with pancreatic and other cancers.~      The physicians have developed techniques for isolating and analyzing cancer cells using a~     simple blood test. They will study how these cells relate to how chemotherapy works. They~     hope to use this information to guide choices of treatment for patients in the future.~   "
159792|NCT01474551|"~     The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on~     the patient and the melanoma. Specifically, the investigators want to know how well~     vemurafenib shrinks melanoma. The investigators also want to find out how well vemurafenib~     can improve how well the patient functions.~   "
159793|NCT01474538|"~     This study will provide information on the use of insulin lispro and insulin aspart in~     insulin pumps in participants with type 2 diabetes.~   "
159794|NCT01474525|"~     This Randomized Controlled Trial (RCT) will test the efficacy of a home blood glucose~     telemonitoring system against usual care in women with gestational diabetes mellitus (GDM) or~     type 2 diabetes mellitus (T2DM) during pregnancy. We hypothesize that the system can improve~     glycemic control in patients, assessed using the mean blood glucose during gestation as the~     primary outcome measure.~   "
159795|NCT01474512|"~     This study will assess the safety and efficacy of LY2439821 compared to placebo in~     participants with moderate to severe, chronic plaque psoriasis.~   "
159796|NCT01474499|"~     This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol~     rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients~     with constipation.~   "
159797|NCT01474486|"~     The purpose of this project is to conduct a preliminary test of the feasibility of a~     multi-micronutrient intervention to improve micronutrient status, cardiac function and~     quality of life in Veterans with Congestive Heart Failure (CHF).~   "
159798|NCT01474473|"~     CACIPLIQ20 is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates.~     Glycosaminoglycans are implied 1) in the stabilization of the micro-environment of cells,~     known as extracellular matrix, by binding to structural proteins, and 2) in the cell~     communication by protecting growth factors. At the site of a lesion, glycosaminoglycans are~     degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By~     replacing damaged glycosaminoglycans, CACIPLIQ20 provides a protective function and restores~     the matrix architecture and the cell communication, a process known as Matrix Therapy.~      As for now, three non-controlled pilot studies have been carried out on small populations.~     They have shown a substantial enhancement of chronic wounds state after treatment with~     CACIPLIQ20. Therefore, the purpose of this new controlled study is to determine whether~     CACIPLIQ20 can shorten diabetic neuropathic plantar ulcers healing when the off-loading is~     mandatory.~      The study's main hypothesis is that CACIPLIQ20 application on a non-healing diabetic plantar~     ulcer in an off-loading mandatory context would reinitiate the natural process of tissue~     regeneration and lead to total wound closure faster than following standard wound care.~   "
159814|NCT01474265|"~     This study has the following primary aim:~      - the main objective of this study is to investigate the effects of smoking cessation during~     quit attempts on sympathovagal balance. These effects will be observed in smokers quitting~     smoking with pharmacological support or without.~      Secondary aims of this study are also:~        -  the definition of MSNA in smokers and non-smokers~        -  the investigation of other parameters concerning the autonomic nervous system, like~          baroreflex-sensitivity, heart rate-variability before and during the quit attempt.~        -  the definition of withdrawal symptoms and craving before, during and after the quit~          attempt.~        -  the investigation of effects of smoking cues on craving and sympathovagal balance~        -  the investigation of relapse rates after smoking cessation in correlation with the~          parameters mentioned above.~   "
159799|NCT01474460|"~     Background: Warfarin is used as an anti-coagulant in patients at risk of developing~     thrombosis. It has a narrow therapeutic index necessitating close monitoring of International~     Normalized Ratio (INR). According to a meta-analysis, patients were in therapeutic range only~     63.6% of the time. This increases the risk of bleeding or thrombosis. Various retrospective~     and prospective studies have looked at supplementation with phytonadione in these patients to~     reduce the variability of INR showing an improvement in variability. Most of these studies~     have only been done in a small number of patients already on warfarin therapy. This study~     will focus on patients newly starting warfarin therapy.~      Methods: This study is a prospective, randomized, controlled trial performed at James A.~     Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will~     receive either phytonadione with warfarin or warfarin alone. Based on a power calculation for~     80%, a total of 370 patients will be enrolled (185 participants in each arm). Participants~     will be randomized to either intervention or control. Intervention group participants will be~     prescribed their usual starting dose of warfarin along with 200 mcg phytonadione by mouth~     daily. Control group participants will be prescribed their usual starting dose of warfarin.~     Both groups will follow the usual standard of care. They will come in for a follow-up INR and~     warfarin dose titration at least once per week until therapeutic, and then as instructed up~     to every 6 weeks thereafter. Both groups will participate in anticoagulation clinic~     activities that constitute the current standard of care. Intervention will last for a total~     of 6 months for each participant once enrolled.~      Hypothesis:Participants in the intervention group being supplemented with 200mcg of~     phytonadione will spend more total time with a therapeutic INR than participants in the~     control group.~   "
159800|NCT01474447|"~     The purpose of the research is to check the efficiency of practicing the tools of the~     Grinberg method (GM) in reducing Low-back Pain (LBP), reducing limitations in movement as a~     result of the pain, and improving the general quality of life.~      The hypothesis suggests that by learning to perceive pain differently, the level of pain will~     reduce and general well-being improved.~   "
159801|NCT01474434|"~     This is a study designed to evaluate the potential for the pradigastat (LCQ908) to impact~     cardiovascular risk.~   "
159802|NCT01474421|"~     This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate~     to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's~     disease.~   "
159803|NCT01474408|"~     The primary aim is to determine the acute effect of two different training interventions on~     venous plasticity in patients with myocardial infarction (MI), revascularization or coronary~     artery graft surgery compared to age-matched healthy subjects.~   "
159804|NCT01474395|"~     Persistent neurocognitive deficits are a major cause of severe disability and impaired~     long-term psychosocial outcome in schizophrenia (SZ). In particular, within the auditory~     system, early deficits such as the behavioral and neurophysiological ability to match tones~     that vary in pitch correlate with impairments in auditory emotion recognition (affective~     prosody) and general functioning, suggesting that interventions aimed at remediating~     sensory-level dysfunction may lead to significant improvement in higher order~     cognitive/emotion processes. Efforts to ameliorate cognitive deficits in schizophrenia~     utilize either pharmacological agents or behavioral treatments such as cognitive remediation,~     which generally focus on higher order processes, and not on the early sensory processing~     which may be key to functioning.~      Numerous pharmacological agents have been proposed, but accumulating evidence suggests that~     dysfunction of the N-methyl-D-aspartic acid (NMDA) receptor may be one of the root causes of~     schizophrenia, including sensory and cognitive impairments, suggesting that an NMDA based~     treatment may be efficacious in reversing these deficits. D-Cycloserine, a synthetic partial~     NMDA agonist has been used in anxiety disorders to augment learning in cognitive remediation.~     Because of a tendency to act as an NMDA antagonist at higher doses D-cycloserine is not~     effective in schizophrenia. In contrast, D-serine (DSR), is a full agonist, and is therefore~     more ideal for enhancing NMDA function and cognitive remediation. While previous use of DSR~     was limited by safety concerns in rodents,the investigators have shown that it can safely be~     used at doses of 60 mg/kg and, moreover, demonstrates converging improvement in symptomatic,~     cognitive and sensory-based measures in schizophrenia. Evidence also suggests that NMDA~     receptor dysfunction in schizophrenia may be relative, rather than absolute, suggesting that~     the enhanced practice of a cognitive remediation paradigm might be able to overcome reduced~     plasticity and treat cognitive dysfunction.~      This project will be the first to combine the NMDA based and sensory-based cognitive~     remediation (SBR) approaches, and will utilize not only DSR, but also a tone matching SBR~     paradigm has been shown to enhance learning in healthy controls, as well as a paradigm~     designed to augment visual motion detection. This study will pilot these interventions in a~     double-blind, placebo-controlled, randomized crossover design that will use neurophysiology~     together with cognitive tests to explore the effects on brain activity and cognitive function~     in 16 patients with schizophrenia or schizoaffective disorder. The investigators hypothesize~     that DSR+SBR will lead to improvement. Subjects will have an initial visit to establish~     baseline performance on cognitive tasks before returning for 3 visits when they will receive~     blinded study medication [60 mg/kg of DSR (2 days) or placebo (1 day)] in a randomized order.~     The procedures on the treatment days will include the SBR paradigm and pre/post~     neurophysiological measurements. Primary outcomes are improvements in neurophysiologic and~     behavioral sensory processing. The main goal is to establish the preliminary efficacy to use~     in a follow-up multi-dose study utilizing a multiple session SBR R01 application.~   "
159805|NCT01474382|"~     The purpose of this study is to determine whether OraVerse is safe and effective for the~     reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.~   "
159806|NCT01474369|"~     The purpose of this study is to investigate the superiority of efficacy of TAK-438, once~     daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.~   "
159807|NCT01474356|"~     The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with~     interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free~     survival (DFS), or acute and late side effects in patients with advanced cervical cancer.~     Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG~     score. Following the completion of radiochemotherapy, consecutive patients with cervical~     cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT~     alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were~     included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was~     administered for 45 minutes before and during the HDR BT. Follow-up examinations were~     scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years, and~     every 6 months throughout the next 3 years. If relapse was suspected, biopsies were obtained~     from these patients.~   "
159808|NCT01474343|"~     The clinical trial P1-SAF-301 is an open-label, single arm, monocentric, phase I/II clinical~     study evaluating the tolerance and the safety of intracerebral administration of~     adeno-associated viral vector serotype 10 carrying the human SGSH and SUMF1 cDNAs for the~     treatment of Sanfilippo type A syndrome The treatment plan consists on a direct injection of~     the investigational medicinal product SAF-301 to both sides of the brain through 6~     image-guided tracks, with 2 deposits per track, in a single neurosurgical session.~      The primary objective is to assess the tolerance and the safety associated to the proposed~     treatment through a one-year follow up.~      The secondary objective is to collect data to define exploratory tests that could become~     evaluation criteria for further clinical phase III efficacy studies.~      Four patients will be included in the clinical trial and will be followed during one year.~      The enrollment and the follow-up of the patients will take place at Bicêtre Hospital. The~     Neurosurgery will be performed at Necker-Enfants Malades Hospital.~      Safety will be evaluating on clinical, radiological and biological parameters.~   "
159809|NCT01474330|"~     To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered~     orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.~   "
159810|NCT01474317|"~     The purpose of this study is to demonstrate that untrained subjects who have diabetes can~     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose~     results.~   "
159811|NCT01474304|"~     Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease~     opioid requirements over the first 12 hours of postoperative recovery following craniotomy.~     Opioids exacerbate symptoms of nausea and vomiting. Reducing postoperative opioid use~     hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.~   "
159812|NCT01474291|"~     This prospective, multi-center, observational study will evaluate factors influencing the use~     of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real~     life setting. Data will be collected from participants for 12 months following initiation of~     tocilizumab treatment.~   "
159813|NCT01474278|"~     This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and~     the safety and tolerability of a single dose of RO5028442 in adult male high-functioning~     autistic patients. In a cross-over design, patients will be randomized to receive either a~     single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated~     time on study is up to approximately 9 weeks.~   "
159815|NCT01474252|"~     The purpose of this study is to evaluate intubation duration between rapid sequence~     intubation technique (RSI) and non-rapid sequence intubation technique (non-RSI) performed by~     emergency medicine residents in Siriraj hospital.~   "
159817|NCT01474226|"~     The purpose of this study is to investigate the digestibility of the amino acid lysine in~     cooked rice in adult men using stable isotope technique.~   "
159818|NCT01474213|"~     The purpose of this study is to compare the sedation effect of dexmedetomidine and target~     controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing~     oral maxillofacial surgery.~   "
159819|NCT01474200|"~     The purpose of the research is to determine if patients have fewer Heart Failure (HF) events~     after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90~     days of discharge from the hospital. Heart Failure events are defined as returning to the~     hospital, clinic or emergency department (ED) for treatment of HF symptoms.~   "
159820|NCT01474187|"~     Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy~     (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some~     current studies showed that irinotecan's dose can be increased significantly for those~     patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial~     to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.~   "
159821|NCT01474174|"~     This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients~     with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective~     immune response and help prevent flu in patients who are receiving chemotherapy for CNS~     tumors~   "
159822|NCT01474161|"~     The Sponsor, Genfit, has developed a new formulation of GFT505 (60 mg). The objective is to~     compare the relative bioavailability between the new GFT505 formulation (capsule dosed at 60~     mg GFT505) and the old GFT505 formulation (capsule dosed at 20 mg GFT505) in healthy male~     subjects and to assess the impact of gender on this relative bioavailability after~     administration in male and female subjects.~      Using the new formulation, a single and a multiple ascending dose study will be performed in~     overweight or obese male subjects otherwise healthy whose demographic and physiological~     characteristics are thought to be closer to those of the target population (Type 2 diabetes).~     Thereafter, a group of male and female patients with Type 2 diabetes will receive multiple~     dose administration of GFT505.~   "
159823|NCT01474148|"~     The purpose of this study is to evaluate a surgically implanted functional electrical~     stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying~     small electric currents to the nerves, which cause the muscles to contract. This study~     evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord~     injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.~   "
159824|NCT01474135|"~     This is a double-masked, randomized, controlled study assessing the safety and ocular~     hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to~     Travatan® Z in patients with elevated intraocular pressure~   "
159825|NCT01474122|"~     The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial~     fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing~     Period 1 continue on their original randomized treatment into Period 2, until the last~     randomized patient has completed Period 1.~      Patients are randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo).~      The primary objective is to demonstrate the effect of macitentan on the reduction of the~     number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers~     (DU).~      Other objectives include:~        -  the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week~          16 in SSc patients with ongoing DU disease.~        -  the evaluation of the safety and tolerability of macitentan in these patients.~        -  the evaluation of the efficacy of macitentan on time to first DU complication during the~          entire treatment period.~   "
159826|NCT01474109|"~     The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial~     fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing~     Period 1 will continue on their original randomized treatment into Period 2, until the last~     randomized patient has completed Period 1.~      Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo).~      The primary objective is to demonstrate the effect of macitentan on the reduction of the~     number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers.~      Other objectives include:~        -  the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week~          16 in SSc patients with ongoing DU disease.~        -  the evaluation of the safety and tolerability of macitentan in these patients.~        -  the evaluation of the efficacy of macitentan on time to first DU complication during the~          entire treatment period.~   "
159827|NCT01474096|"~     The purpose of this study is to determine whether an implementation strategy for a~     breastfeeding guide is more effective than the usual practice (simple circulation of the~     guide) in terms of increasing the percentage of children receiving exclusive or preferential~     breastfeeding at 6 months age.~   "
159828|NCT01474083|"~     The purpose of this trial is to study the drug levels and biomarkers in the body and the~     safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the~     study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4~     treatments will be placebo, which does not contain an active ingredient. The study~     participation includes in-patient and out-patient days.~   "
159829|NCT01474070|"~     IOP is measured with two devices (Dynamic Contour Tonometry (DCT) and Goldmann applanation~     tonometry (GAT)).~   "
159830|NCT01474057|"~     This study will compare a cognitive-behavioral online self-management intervention designed~     for primary care treatment of war-related PTSD to a control intervention, optimized usual~     primary care PTSD treatment. Patients with PTSD will be trained to use the online PTSD~     treatment website and asked to do so three times per week for six weeks. They will have phone~     and email access to a nurse trained to assist them in their treatment program. Three~     scheduled phone check-ins during the six week treatment period will provide ongoing contact~     with patients during treatment. The investigators will assess PTSD symptoms, depression,~     anxiety and somatic symptoms, physical health status and occupational functioning on three~     occasions: before the intervention, at the end of the treatment period, and six weeks after~     the end of treatment.~   "
159831|NCT01474044|"~     The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and~     effective in the treatment of chronic atrophic gastritis (CAG).~   "
159832|NCT01474031|"~     Research protocol prospective study Deltamotion - DAA THA study~        1. Introduction Very few gait analytical data are available concerning the Direct Anterior~          Approach (DAA) in total hip arthroplasty (THA). All the studies have focused on~          immediate post-operative recovery. These studies have in general some important~          shortcomings in order to accurately evaluate the biomechanics of the replaced hip joint.~          None of the published reports have reported on consecutive intervals of pre-op - 6w - 3m~          - 6m - 12m. This is of interest as we know that recovery with other approaches takes >1~          year. It might be that the DAA approach leads to normal gait patterns at 3m or 6m and~          that these patterns do not differ from the normal pattern or at >1y post-op. None of the~          reports utilized out-of-plane movements such as coming down or up stairs or squads.~          Muscle strength of the abductors has not been tested. Utilizing trunk markers is~          frequently not done but it is important to evaluate the centre of mass position during~          gait. Very few studies utilize kinetic data, which are important in order to thoroughly~          evaluate the biomechanics and loading of the hip. And maybe most importantly, the~          biomechanical effect of the diameter of the articulating surface on gait parameters~          following the DAA has never been evaluated.~           One of the most important advantages of the DAA is the muscle sparing aspect and the~          presumption that the femoral anatomy and biomechanics can be more accurately and~          precisely restored. If the diameter of the articulating surface has then also been~          reconstructed to the almost anatomical diameter, we can assume that this should be the~          most optimal reconstruction of the hip joint currently available. This could lead to~          early return to normal gait, to optimal joint loading and a minimal amount of stress~          shielding of the femoral bone.~           The aim of this project is (1) to prospectively analyse the biomechanics of the hip~          joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior~          Approach and (2) to assess the femoral bone remodelling around the fully coated Corail~          stem over the first year post-operatively.~        2. Materials and Methods Hypothesis: (1) The temporo-spatial parameters (velocity, cadence,~          step length, and stride length) and gait kinematic and kinetic data (external hip and~          knee muscle moments) are not significantly different between the study and control group~          at the evaluated time intervals indicating normal or near normal gait patterns in the~          early post-operative recovery phase. (2) Stress shielding of the bone around the femoral~          stem as measured with the DEXA scan can be predicted accurately with the FE analysis~          based on the collected data indicating the validity of the musculoskeletal models.~      Estimated inclusion time: 1 July 2011 - 31 December 2011 Cohorts: 20 DAA subjects - 20~     control subjects~      Assessments:~        -  Time interval: pre-op - 3m - 6m - 12m~        -  Assessment of all subjects:~             -  XR with magnification marker~             -  Biodex force measurement in flexion and extension and mid flexion (with EMG if~               possible)~        -  Gait analysis with surface EMG and trunk markers:~             -  Unipodal standing: 3 trials Right and 3 trials Left on FP~             -  Level walking: 3 trials Right and 3 trials Left on FP~             -  Chair rise: 3 trials, both legs on FP~             -  Stair ascent: 3 trials Right and 3 trials Left on first FP~             -  Stair descent: 3 trials Right and 3 trials Left on first FP~             -  Squat: 3 trials, both legs on FP~             -  Bipodal squat: 3 trials Right and 3 trials Left on FP~        -  Functional scores (HHS, UCLA, HOOS, SF-36)~        -  DEXA scan pre-op and at 12 months~        -  Assessment of final 5 subjects per group:~             -  CT pre and post at 6w (pre: pelvis-knee and post: hip)~             -  MRI pre and 1 y post~             -  Accelerometer 1 week~   "
159833|NCT01474018|"~     QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2~     diabetes will result in improved glycemic control, reduced exogenous insulin requirement,~     increased lean fat mass and improved pancreatic beta-cell function.~   "
159834|NCT01474005|"~     This study aims to evaluate the effectiveness of an artificial larynx on the restoration of~     laryngeal functions, mainly breathing and swallowing.~   "
159836|NCT01473979|"~     Sternal osteomyelitis and poststernotomy mediastinitis is a severe and life-treating~     complication after the cardiac surgery. The incidence of sternal osteomyelitis ranges from 1%~     to 3% with a high mortality rate from 19% to 29% .~      The most devastating complication of the open sternum is the laceration of the right~     ventricle which has a very high mortality. Additionally destabilizations of the thoracic~     cage, prolonged immobilization, or substantial surgical trauma are further complications of~     the conventional strategy (4). In addition, postoperative infections after sternotomy are~     associated with prolonged hospital stay, increased healthcare costs and impaired quality of~     patient life, representing an economic and social burden. The emergence of increasing~     antimicrobial resistant bacteria augments the importance of postsurgical infections since the~     antimicrobial choices are becoming limited. Furthermore, the incidence of infection is an~     indicator for the quality of patient care in the international benchmark studies.~      Although several therapy strategies are nowadays present in clinical practice, there is a~     lack of evidence based surgical consensus for treatment of this surgical complication. In~     most case the poststernotomy mediastinitis is involving surgical revision with debridement,~     open dressing and/or vacuum assisted therapy. After the granulation tissue on open chest~     wound was achieved secondary closure and/or reconstruction with vascularized soft tissue~     flaps such as omentum or pectoral muscle is performed.~      It seems there is a need for more effective surgical treatment of poststernotomy wound~     infections, which may address the prolonged hospitalization and reduce number of surgical~     interventions and with this also perioperative morbidity. In light of this we propose a~     randomized study comparing new delay primary closure of the sternum to the secondary vacuum~     assisted closure.~   "
159837|NCT01473966|"~     Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit~     (ICU) patients.~   "
159838|NCT01473953|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate the safety, tolerability and pharmacokinetics (exposure in the body) of~     liraglutide-depot in healthy subjects.~   "
159839|NCT01473940|"~     This phase I trial studies the side effects and best dose of ipilimumab when given together~     with gemcitabine hydrochloride in treating patients with stage III-IV or recurrent pancreatic~     cancer that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or tumor-killing substances to them. Drugs~     used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to kill tumor~     cells or stop them from growing. Giving monoclonal antibody therapy together with~     chemotherapy may kill more tumor cells.~   "
159840|NCT01473927|"~     Background Determining disease activity in IBD is sometimes difficult and, to be accurate,~     requires endoscopy. The serum marker CRP has not proven sufficiently valuable as a marker for~     IBD specific inflammation. As an alternative, so far fecal calprotectin appears to be more~     reliable and has shown a certain value as predictive marker. Our preliminary data now show,~     that the serum concentrations of ficolin-2 are significantly higher in CD patients with a HBI~     >3. Ficolin-2 is a lectin and acute phase protein produced in the liver and, like MBL, can~     activate the lectin pathway of complement. Unlike MBL, deficiency for ficolin-2 was not~     detected in our patient cohort, nor could we find functional deficiencies for ficolin-2~     (paper submitted).~      Study Aims The study is aimed to substantiate the data from our pilot study which shows that~     ficolin-2 is significantly increased in CD patients during inflammation. Therefore, the study~     will measure ficolin-2 concentrations in a sufficiently large patient group to obtain enough~     statistical power and to compare these results with the endoscopic disease score (SES-CD) and~     CRP and calprotectin values. Statistical analysis of the data will show us if ficolin-2 is a~     reliable and easy to obtain new marker for active inflammation in CD.~      Study Design Based on a power analysis 112 CD patients and 112 UC patients need to be~     analyzed. They will be recruited from Bern, Basel and Lausanne. Only patients with routine~     endoscopy will be included in the study and will be scored by SES-CD. Blood samples will be~     collected at the day of endoscopy. Stool sample will be collected within the same week of~     endoscopy. Calprotectin and CRP concentrations will be determined by routine diagnostics,~     ficolin-2 concentrations will be determined by ELISA in our laboratory. Finally, all data~     will be statistically analyzed.~   "
159841|NCT01473914|"~     A pilot randomized trial that compares a new renal nutritional supplement with the standard~     renal vitamin.~      The primary objective is to compare two doses (medium and high) of the new supplement with~     the renal vitamin currently being prescribed to people with End Stage Renal Disease (ESRD).~      Secondary objective is to demonstrate the feasibility of recruitment for a definitive larger~     trial.~   "
159842|NCT01473901|"~     This clinical study will assess the doses of BKM120 appropriate for patients with newly~     diagnosed glioblastoma when given in combination with radiotherapy and temozolomide.~   "
159843|NCT01473888|"~     Purpose: This study is to determine the effect of T89(Dantonic®)on P450 enzymes. This study~     will help determine which types of drugs may interact with T89.~   "
159844|NCT01473875|"~     This phase 2/3, open-label extension study will evaluate the long-term efficacy and safety of~     intravenous (IV) infusions of SBC-102 in children with Lysosomal Acid Lipase (LAL) Deficiency~     who previously received treatment with SBC-102.~   "
159845|NCT01473862|"~     Teen loss is not uncommon. Depression, emptiness, disbelief, hopelessness, and guilt are~     typical responses. How teens with cancer cope with the loss of a loved one or a close friend~     has not been well-studied in the bereavement or oncology literature. This study will describe~     the impact of loss on teen patients who are on treatment or have recently completed treatment~     for malignancy. We will look at baseline personality traits and ask teens to identify losses~     in their life. We will ask questions about coping and meaning-making after loss. A parent~     will be invited to participate -to measure parental awareness of teen loss and determine if~     parental coping affects teen coping. The inventories have been validated by other~     researchers.~   "
159846|NCT01473849|"~     The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver~     transplant recipients remains controversial. Although some studies (Teixeira et al., 2000;~     Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV~     infection, studies such as Rosen et al. show that 50% of patients with CMV infection suffered~     cirrhosis durig follow-up period, while between not-infected patients the rate was 11%. To~     clarify this question, a non-interventional study will be carried out in order to assess if~     CMV replication is a risk factor for graft dysfunction in liver transplant recipients.~   "
159847|NCT01473836|"~     The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult~     subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day~     in combination with ceftriaxone sodium.~   "
159859|NCT01473680|"~     This study is being done to find out if it is possible to enroll minority women with breast~     cancer in a study of how chemotherapy may affect their ability to answer certain questions~     and perform certain tasks that measure brain activity. The investigators want to look at~     thinking and brain activity in patients to see if cancer treatments can cause any brain~     changes. For this study, women without cancer, are being asked to participate in order to~     compare the answers to the questions and the brain wave activity measured in the women with~     cancer to women who don't have cancer.~   "
159860|NCT01473667|"~     The purpose of this study is to investigate clinical outcomes from two current standard of~     care pain control procedures performed for patients undergoing pacemaker insertion.~   "
163134|NCT01430533|"~     The purpose of this study is to determine the dermal sensitization potential of azelaic acid~     pre-foam formulation.~   "
159848|NCT01473823|"~     Although some causal factors in allergy development such as allergen exposure and~     environmental pollution have decreased during recent years, the incidence of the allergic~     diseases has increased in the Western world. Since the genetic predisposition to develop~     allergies cannot change in such a short time it is conceivable that, instead of the emerging~     of some new and unknown risk factors, some protective factors seem to have disappeared in the~     Western world.~      Allergic disease is a tendency to develop allergies to allergens in the surrounding~     environment. The most common symptoms are eczema and food allergy in the early life,~     bronchial asthma (AB) later in childhood and allergic rhino conjunctivitis (ARC) during~     school age and adolescence, the so-called allergic march. Some person may develop only one,~     but others some or all of the symptoms. Inheritance, environment and allergen exposure are~     important factors affecting this march but there are important factors that predict later~     development of diseases. Sensitization to egg (positive skin prick test or specific IgE to~     egg in the serum) combined with skin problems in infancy predispose strongly to the~     development of allergic asthma in later life.~      The purpose of this work is to supply children with early development of IgE associated~     eczema and food allergy with omega-3 LCPUFA before the age of 12 months and assess the effect~     of the supplementation on the future development of skin symptoms, food allergy,~     sensitisation against inhalant allergens and asthma in these children. We will also assess~     immunological markers of Th2-skewed immunity in relation to clinical effect of the~     supplementation.~      Families with children younger than 12 months referred to the paediatric department at~     Linköping University Hospital, Motala, Norrköping and Jönköping Hospitals in the South East~     of Sweden, with the diagnosis IgE associated eczema and sensitised against food allergens~     (egg, milk, wheat and/or soya) will be invited to participate in this study. Clinical~     examination by a paediatrician and assessment of disease severity with SCORAD will be~     performed by a research nurse at inclusion. The children will be assessed every six months by~     a nurse until 2.5 years of age and by a paediatrician at 3 years of age. Later clinical~     assessment will be performed yearly until age 7.~   "
159849|NCT01473810|"~     HIV-specific cellular immunity is hampered in most HIV-infected individuals. Therapeutic~     immunization in HIV aims to strengthen the HIV-specific cellular immunity, usually in the~     absence of replicating HIV with antiretroviral drugs. The aims of this strategy can be to~     decrease the mass of latently infected CD4+ T cells, better tolerance of drug-free periods,~     and better select candidates for preventive HIV vaccines.~      Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four,~     slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal~     injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found~     improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at the~     AIDS vaccine 2011 conference, Bangkok).~      In this study the investigators hypothesize that the Vacc-4x peptides, deposited on the nasal~     mucosal surfaces in conjunction with Endocine, a newly developed and documented mucosal~     adjuvant, will induce T cell responses to HIV and improve HIV-specific immunity both~     systemically and at mucosal surfaces (oral, rectal, vaginal).~   "
159850|NCT01473797|"~     ECLA is a phase II, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5~     days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary~     Langerhans cell histiocytosis and impairment of lung function patients.~   "
159851|NCT01473784|"~     This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with~     benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for~     head and neck cancer and may have fewer side effects and improve recovery~   "
159852|NCT01473771|"~     The purpose of this multi-site randomized controlled trial is to determine if the Caring~     Letters intervention is effective in preventing suicide and suicidal behaviors among U.S.~     Service Members and Veterans. The primary aim of this project is determine whether caring~     communications following inpatient psychiatric treatment reduce suicide and self-inflicted~     injuries among U.S. military personnel and Veterans. The investigators will also explore~     treatment utilization by comparing the frequency of treatment visits after enrollment into~     the study. The following specific hypotheses will be tested:~      Hypothesis 1: During a two year follow-up after the index hospital discharge, the frequency~     of suicide will be lower among participants in the Caring Letters group compared to those in~     the Usual Care group.~      Hypothesis 2: The frequency of medically admitted self-inflicted injuries will also be lower~     in the Caring Letters group compared to the Usual Care group.~      Hypothesis 3: The time to suicidal act, among those who do subsequently exhibit one, will be~     longer among participants in the Caring Letters group compared to the Usual Care group.~   "
159853|NCT01473758|"~     The purpose of this trial is to investigate if roflumilast can reduce the neutrophilic~     inflammation at acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). In~     addition, the potential benefit of roflumilast on severity and recovery periods of acute COPD~     exacerbations will be assessed using patient diaries and questionnaires.~   "
159854|NCT01473745|"~     study hypothesis~        1. The aim of this study:~           How can the investigators predict and control the nasal changes after maxillary LeFort I~          osteotomy with 2 different alar base suture techniques ?~        2. Study hypothesis~             -  Null hypothesis: Nasal changes were not affected by 2 different alar base suture~               techniques after maxillary LeFort I osteotomy~             -  Alternative : Nasal changes were affected by 2 different alar base suture~               techniques after maxillary LeFort I osteotomy~   "
159855|NCT01473732|"~     The purpose of this study is to find out how well the current drug regimen (including low~     Prograf dose and Myfortic, which is usually recommended to prevent any further deterioration~     in the kidney function) works and how safe it is when compared to a combination of Zortress~     and Myfortic in patients with chronic kidney injury associated with Prograf or Neoral use.~   "
159856|NCT01473719|"~     The purpose of this study is to if a brief motivational intervention, compared to health~     education sessions, reduces alcohol and marijuana use and is related to fewer sexually~     transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana use.~   "
159857|NCT01473706|"~     The purpose of this study is to compare the accuracy of a new consumer nutrition screening~     tool to an established and validated nutrition screening tool currently completed by~     healthcare practitioners.~   "
159858|NCT01473693|"~     The purpose of this study is to learn about the effects of cancer treatment on the brain.~     Some cancer patients report changes in their memory or thinking after treatment. These~     changes could be a result of changes in brain structure, such as a change in size or~     thickness of different parts of the brain. The investigators will look to see if these~     changes in brain structure happen through the results of magnetic resonance imaging (MRI).~     The investigators will do this by looking at the brain structure of lung cancer patients who~     have surgery and chemotherapy versus those who have surgery only.~   "
159861|NCT01473654|"~     The goal of this randomized control trial is to study the impact of an electronic health~     record embedded tool's ability to facilitate shared provider-patient goal setting to promote~     lifestyle behavior change and prevent diabetes in primary care.~   "
159863|NCT01473628|"~     The goal of this clinical research study is to learn if adding rituximab to radiation therapy~     will help control the disease better than radiation alone. The safety of this combination~     will also be studied.~      Radiation therapy is designed to kill cancer cells or to stop cancer cells from growing.~      Rituximab is designed to attach to cancer cells that have CD20 (a tumor marker) on their~     surface and damage them, which may cause the cells to die.~      This is an investigational study. Radiation and rituximab are FDA approved and commercially~     available for patients with lymphoma.~      Up to 130 patients will take part in this study. All will be enrolled at MD Anderson.~   "
159864|NCT01473615|"~     The primary aim of this study is to test the feasibility and efficacy of Mindfulness Based~     Cognitive Therapy (MBCT) training for the treatment of depressive symptoms in patients with~     chronic pain. The study also aims to elucidate the mechanisms underlying MBCT on a~     psychological and neurobiological level. For this purpose the study subjects will fill out~     several psychological questionnaires related to mindfulness, depression and chronic pain.~     Moreover this study involves optional fMRI scans of the brain and blood measures before and~     after the intervention.~      Main hypotheses:~        1. The MBCT training will be a feasible intervention in patients with chronic pain and~          co-morbid depression as defined by no occurrence of serious adverse events related to~          the intervention and a retention rate of more than 70% in the subjects assigned to the~          MBCT arm.~        2. Patients who have completed the MBCT training will demonstrate a significant decrease in~          depressive symptoms as measured on the Quick Inventory of Depressive Symptomatology -~          Clinician rated (QIDS-C16), and the Hamilton Rating Scale for Depression (HRSD17)~          (QIDS-C/HRDS) severity scale for depressive symptoms (the primary outcome measure),~          compared to the control group.~   "
159865|NCT01473602|"~     The purpose of this study is to see whether teriparatide, given for 6 months versus placebo,~     will improve the healing of hip (femoral neck) fractures that are repaired during surgery~     using certain types of orthopedic screws. The study will enroll men and postmenopausal women~     at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for~     example, fall from standing height or less).~   "
159866|NCT01473589|"~     The purpose of this study is to see whether teriparatide, given for 6 months versus placebo,~     will improve the healing of hip (femoral neck) fractures that are repaired during surgery~     using certain types of orthopedic screws. The study will enroll men and postmenopausal women~     at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for~     example, fall from standing height or less).~   "
159867|NCT01473576|"~     A diet rich in leafy green vegetables has been shown to reduce the risk of developing chronic~     metabolic disease. The health benefits from these particular vegetables may be attributed to~     their high nitrate content. Recent work suggests that dietary nitrate triggers endogenous~     nitric oxide release, thereby stimulating vasodilation and improving muscle perfusion in an~     insulin-independent manner. We hypothesize that in an insulin-resistant state, nitrate~     co-ingestion will increase muscle perfusion, thereby improving post-prandial delivery of~     nutrients to skeletal muscle tissue. Specifically, a more efficient delivery of food derived~     amino acids will stimulate post-prandial muscle protein synthesis and, as such, compensate~     for a blunted muscle protein synthetic response to food intake in the elderly. This proposal~     will investigate the efficacy of nitrate co-ingestion as a means to augment muscle protein~     synthesis in elderly, type 2 diabetes patients and may lead to a novel therapy in the~     clinical care of type 2 diabetes patients.~   "
159868|NCT01473563|"~     The main purpose for this study is to answer the following research questions:~        -  Can pemetrexed be administered safely at the participant's home, using the same~          treatment procedure as in a hospital setting?~        -  Will the participant be satisfied with home care?~        -  How might this impact the participant's quality of life?~        -  What are the required medical resources needed to give pemetrexed in a home setting?~   "
159869|NCT01473550|"~     Patients with mood disorder or psychotic disorder will be given handheld devices with~     personal health records to educate, monitor and deliver customizable healthcare tools based~     on their personal needs. The use of technology has great potential to deliver care more~     effectively and efficiently. No actual information is on the handheld device - it is accessed~     from a secure site behind hospital firewalls.~   "
159870|NCT01473537|"~     Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design:~     Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution~     (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.~      Procedure: Rinses are performed in the evening. The rinse combinations are given in a random~     order, and the subjects are unaware of the sequence. At least 3 days separates the use of~     each rinse. Dosage: 20 mL and 1 minute rinse with each solution.~      Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by~     expectoration.~      Analysis: The fluoride concentration in saliva samples are analysed Statistics and data~     handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated~     measures design.~   "
159871|NCT01473524|"~     The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist. FXR~     is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to~     help with digestion. It is hypothesized that regular treatment with OCA will improve liver~     function in persons with Primary Biliary Cirrhosis (PBC).~   "
159872|NCT01473511|"~     Strongest Families (formerly Family Help)is an evidence-based, distance health education~     model for families who have children with behavioural difficulties. The principal research~     question is Does Strongest Families, a 12-week, home-based program of interactive readings,~     instructional videos, homework projects, and weekly coaching telephone calls out perform~     the care families typically experience when referred to a mental health service?. The~     investigators hypothesize that children randomized to Strongest Families intervention will~     show a significantly greater reduction in externalizing behaviour problems than those~     randomized to a Control (usual care). In addition, parents randomized to Family Help will~     report a greater improvement in parenting skills and a greater reduction in symptoms of~     emotional distress (i.e., feeling of anxiety, depression, and stress) than parents in the~     Control condition. Finally, families randomized to Family Help will use fewer mental health~     services than Controls.~   "
160254|NCT01468467|"~     The purpose of this study is to define a safe dose of AC220 when given as maintenance therapy~     after treatment with an allogeneic stem cell transplant.~   "
159873|NCT01473498|"~     Sepsis is the most severe complication of infections. Sepsis-associated Acute kidney injury~     (AKI) is commonly encountered in critically ill patients and independently predicts poor~     outcome. Unfortunately, no drug or management strategy was able to reduce incidence of AKI.~     To adapt the level of mean arterial pressure according to local renal hemodynamic evaluated~     by renal Doppler could lead to a better renal perfusion, and then less AKI.~   "
159874|NCT01473485|"~     A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound~     Surgery in the Treatment of Brain Tumors~   "
159875|NCT01473472|"~     This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel~     groups is designed to evaluate a strategy for the prevention of HIV infection including on~     demand antiretroviral pre-exposure with Truvada versus placebo, associated with overall~     prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B~     virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV~     infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed~     recent studies have reported a higher incidence of new HIV infection in MSM as compared to~     the general population, new approaches to the prevention of HIV infection are, therefore,~     necessary in order to consider the limits of current strategies.~   "
159876|NCT01473459|"~     The purpose of this study is to compare two fertility protocols in obese women with~     Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These~     protocols carry less risk of ovarian hyperstimulation syndrome which these women may~     experience.~   "
159877|NCT01473446|"~     Is goal directed fluid therapy reducing postoperative complications in comparison to~     traditional fluid therapy for gastro surgical ASA III/IV patients?~      The investigators compare two groups of patients: one group receives goal directed fluid~     therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the traditional~     fluids, ie the current regime.~   "
159878|NCT01473433|"~     The purpose of this trial is to evaluate safety and efficacy of a pericardial adipose pedicle~     transposition (adiFLAP) for the improvement of cardiac function in patients with a chronic~     myocardial infarct. Preclinical studies in the porcine model of myocardial infarction have~     shown that AdiFLAP reduces infarct area.~   "
159879|NCT01473420|"~     The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC)~     Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels~     and study drug dose requirements in patients treated for anemia associated with chronic renal~     failure and on hemodialysis.~   "
159880|NCT01473407|"~     The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira~     compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose~     requirements in patients treated for anemia associated with chronic renal failure and on~     hemodialysis.~   "
159881|NCT01473394|"~     The purpose of this study was to further characterize the efficacy, safety, and tolerability~     of a single fixed dose level of vilazodone compared to placebo in patients with major~     depressive disorder.~   "
159882|NCT01473381|"~     The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed~     dose levels of vilazodone compared to placebo in patients with major depressive disorder.~   "
159883|NCT01473368|"~     The purpose of this study is to compare and contrast the effects of the probiotic~     Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the~     gut microbiota of healthy volunteers.~   "
159884|NCT01473355|"~     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 3mm~     diameter implant in a Chinese population by evaluation of marginal bone level alteration,~     implant stability and implant survival in the posterior mandible up to 3 years after loading.~     Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.~   "
159885|NCT01473342|"~     This study is focused on the development and pilot/feasibility testing of a smartphone~     application to promote a healthy diet, increase physical activity, and prevent weight gain in~     adolescent survivors of childhood cancer.~   "
159886|NCT01473329|"~     Education is the mainstay of treatment of diabetes mellitus (DM), since it is through her~     that patients are trained to perform the management of your disease. There is a wide range of~     educational interventions tested in patients with DM, not having been defined so far a~     universal template that can be standardized and recognized as effective for all individuals~     with the disease. The present study aims to evaluate the effect of a group based structured~     education program, applied by a primary care generalist nurse, on metabolic control of type 2~     diabetes mellitus (DM2) patients attending a primary care unit.~   "
159887|NCT01473316|"~     This will be an open-label, fixed-sequence, single-center, 2 period study. The study is~     designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980.~   "
159888|NCT01473303|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan~     hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     ganitumab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry cancer-killing~     substances to them. It is not yet known whether giving more than one drug (combination~     chemotherapy) is more effective with or without ganitumab in treating patients with~     pancreatic cancer.~      PURPOSE: This phase I/II trial is studying the best dose of combination chemotherapy and~     ganitumab and how well combination chemotherapy with or without ganitumab works in treating~     patients with previously untreated metastatic pancreatic cancer.~   "
159889|NCT01473290|"~     RATIONALE: Probiotic therapy may reduce or prevent gastrointestinal complications in patients~     undergoing chemotherapy and pelvic radiation therapy.~      PURPOSE: This randomized phase III trial is studying how well probiotic therapy works in~     preventing gastrointestinal complications in patients undergoing chemotherapy and pelvic~     radiation therapy.~   "
159890|NCT01473277|"~     The aim of this study is to confirm the efficacy and safety of the intra-articular injection~     of BT-A in a multicentric double blind randomised study. For this purpose intra-articular~     injection of BT-A will be compared with the intra-articular steroid injection that is the~     current gold standard for the treatment of HSP.~   "
159891|NCT01473264|"~     Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result~     of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical~     ventilation and infection. These conditions initiate an inflammatory response characterized~     by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the~     development of significant acute and chronic lung injury.~      The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10~     is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is~     the most abundant protein in the mucosal fluids in normal healthy lungs.~      The purpose of this study was to evaluate the pharmacokinetics, safety, tolerability and~     anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated~     premature infants receiving positive pressure ventilation for treatment of respiratory~     distress syndrome (RDS) to prevent long term respiratory complications referred to as~     bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (CRM;~     asthma, cough, wheezing, multiple respiratory infections).~      CC10 regulates inflammatory responses and protects the structural integrity of pulmonary~     tissue while preserving pulmonary mechanical function during various insults (eg. viral~     infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties~     suggest that administration of rhCC10 may help to facilitate development of normal airway~     epithelia and prevent the inflammation that leads to CRM in these infants.~   "
159892|NCT01473251|"~     The purpose of this study is to measure biomarkers in the vitreous of patients undergoing~     Lucentis or avastin treatment.~   "
159893|NCT01473238|"~     Paper-based data collection for prospective clinical trials is associated with a poor quality~     of data collection. This typically involves missing or wrong data entry or a low recruitment~     rate, mainly due to the cumbersome and uncontrolled data collection.~      Electronic data collection is associated with improved quality of data entry in the cases of~     Electronic Patient Records (EPR) and patient handover among doctors during night and day~     shifts. However, a comprehensive direct comparison between web-based desktop personal~     computer (PC) and mobile (e.g. iPad) data collection has not yet been reported.~      The purpose of this prospective trial is to compare the users' experience with the web-based~     desktop PC and mobile data collection (iPad) tools.~   "
159894|NCT01473225|"~     This study is a test of possible mechanisms by which calorie labels might lead people to~     increase calorie intake. The investigators hypothesize that calorie labels might increase~     calorie intake because 1) people infer that higher calorie foods are tastier, 2) calorie~     labels invoke thoughts of dieting, leading people to overconsume as a reaction, 3) people try~     to maximize calories consumed per dollar spent, and 4) calorie labels change one's goal~     motivation toward food, causing people to eat more.~   "
159895|NCT01473199|"~     Information will be collected on the pre-op and post-op clinical status of patients with~     focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial~     Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to~     increase the knowledge of patient outcomes such as pain, knee function, level of activity,~     and overall quality of life after treatment with the device. Patients will be followed for 5~     years after surgery.~   "
159896|NCT01473186|"~     Objectives: Given the profound impact of obesity on the genesis of endometrial cancer, this~     study proposes to prospectively evaluate the baseline prevalence of menstrual irregularities~     and endometrial pathology in morbidly obese women and discover risk stratification markers~     that can potentially identify the highest risk women who might benefit from targeted cancer~     prevention strategies in a future clinical trial.~        -  Specific Aim 1: To assess the prevalence of menstrual irregularities and to correlate~          gynecologic and menstrual history with the perceived personal risk and severity of~          gynecologic cancers in a population of female bariatric surgery candidates.~        -  Specific Aim 2: To determine the prevalence of endometrial hyperplasia and cancer in~          morbidly obese women undergoing bariatric surgery.~        -  Specific Aim 3: To obtain adipose, endometrium, and blood samples (before and after)~          bariatric surgery to assess baseline hormone levels and adipocyte-derived factors and to~          correlate with presence of menstrual irregularities, endometrial hyperplasia or cancer,~          and with postsurgical weight changes.~      Methods:~        -  Specific Aim 1: After informed consent is obtained, a survey and medical history of~          prospective bariatric surgery patients will be performed at the University of Virginia.~        -  Specific Aim 2: For those women who undergo bariatric surgery, study investigators will~          perform endometrial biopsies at the time of bariatric surgery on participants to~          determine the status of the endometrial lining and the potential presence of endometrial~          cancer and its precursors.~        -  Specific Aim 3: At the time of surgery, blood, adipose, and endometrial tissue samples~          will collected for evaluation of adipocyte-related factors and correlation with clinical~          endpoints. Blood will also be collected at 6 and 12 months after surgery.~      Anticipated results: This study will identify the prevalence and correlation of menstrual~     irregularities with endometrial abnormalities and cancer in morbidly obese women as well as~     define their perceived risk of developing cancer. Serum biomarkers in obese women with and~     without endometrial cancer/precancer would be evaluated for correlation and potential~     applicability for endometrial cancer screening in this high-risk population. Most~     importantly, this study may provide evidence as to whether screening (via endometrial biopsy~     or other serum markers) is warranted in asymptomatic, morbidly obese women and suggest~     potential preventive and risk reduction mechanisms.~   "
159897|NCT01473173|"~     The objectives of this study are:~        -  To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in~          healthy male subjects.~        -  To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy~          male subjects.~        -  To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy~          male subjects.~        -  To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and~          esomeprazole in healthy male subjects.~   "
159898|NCT01473160|"~     The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked~     daily disposable contact lens as compared to a commercially available daily disposable~     contact lens.~   "
159899|NCT01473147|"~     Background: Continuous subcutaneous insulin infusion (CSII) has been demonstrated to be an~     effective clinical tool for intensive insulin therapy in Type 1 diabetic patients. Type 2~     diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1)~     levels. Injection of GLP-1 receptor agonists are associated with improved glycemic control.~     Nevertheless, the clinical effects and mechanisms are still unclear when additional~     supplement of GLP-1 analogue in cooperation with intensive CSII treatment for poorly~     controlled Type 2 diabetes patients. This study is designed to understand the complementary~     pharmacological effects of GLP-1 analogue on intensive CSII treatment.~      Methods: Sixty poorly controlled Type 2 diabetes patients will be admitted to the ward for 6~     days CSII intensive treatment. Following the normalization of blood glucose at first 3 days,~     the patients are randomly assigned with combined therapy with exenatide injection or saline~     for another 3 days. The clinical assessments of insulin requirement, insulin secretion,~     insulin resistance glycemic excursions and cytokines will perform immediately during or after~     the study.~   "
159900|NCT01473121|"~     This registry study is national, multi-center, prospective study without any interventions to~     the treatment strategies and/or decisions of the investigators. It is designed in order to~     determine the general profile of HCC patients in Turkey. Socio-demographic characteristics,~     family history, medical history and treatment pattern of HCC patients will be evaluated.~   "
159902|NCT01473095|"~     This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to~     subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed~     to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to~     define a recommended Phase 2 dose of ARQ 092.~   "
159903|NCT01473082|"~     The purpose of this study is to evaluate whether patients with trochanteric fractures being~     treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be~     mobilized than patients without augmentation.~   "
159904|NCT01473069|"~     The purpose of this study was to determine the safety, tolerability and pharmacokinetics of~     sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also~     to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic~     profile of JTK-853 and its metabolite M2 (one cohort only).~   "
159905|NCT01473056|"~     The purpose of this study was to determine the safety, tolerability, pharmacokinetics and~     anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on~     reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by~     genotypic resistance monitoring for up to one year after study drug treatment.~   "
159906|NCT01473043|"~     This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell~     variant), who have failed first line therapy. The study will recruit a maximum of 30 patients~     from 2 countries including Australia and Canada. Patients will be followed up for efficacy,~     safety and health related outcomes.~   "
159907|NCT01473030|"~     The overall goal of this project is to quantify the long-term effects of dutasteride on the~     architectural and nuclear features of benign prostate tissue, using state-of-the art digital~     image analysis techniques. The ultimate result will be a multivariable morphological~     signature that could provide a useful indicator of an individual's degree of drug response.~   "
159908|NCT01473017|"~     This study employs a Randomised Controlled Trial design to investigate whether a CBT-based~     guided self-help intervention can improve anxiety, depression, psychological well-being,~     quality of life, Diabetic self-care and adherence; as compared to controls. The study aims to~     recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety and~     depression are common in patients with Type 2 Diabetes, and has been shown to affect Diabetes~     control. Literature suggests that CBT can benefit individuals with Diabetes and comorbid~     mental ill-health, however little research has been done to date on the effect of guided~     self-help in this population. It is expected that this intervention will improve patient's~     mental health, as well as extend the limited knowledge-base on guided self-help in chronic~     illness.~   "
159909|NCT01473004|"~     The purpose of this study is to determine whether radiation provided locally to the liver~     tumor vasculature environment will demonstrate a response of tumor decline. This radiation~     may cause the tumor cells to die.~   "
159910|NCT01472991|"~     Study is to assess if TC-5619 improves symptoms for adults diagnosed with the~     inattentive-predominant subtype of ADHD over a 4-week treatment period.~   "
159911|NCT01472978|"~     The investigators found that community acquired C. diff occurs in children undergoing a~     colonoscopy. When they were treated their symptoms got better. But, the investigators do not~     know if the treatment for the C. diff made them better or another other factor made them feel~     better. So, the investigators designed the following study. Children undergoing a colonoscopy~     who are found to be C. diff positive at the time of the colonoscopy are randomized to one~     group that gets immediate treatment or a second group that gets delayed treatment. Both~     groups are closely monitored for symptoms.~   "
159912|NCT01472965|"~     Use of long-term central venous access devices (including tunneled lines and ports) can be~     associated with development of bloodstream infection caused by build-up of bacteria or fungus~     on the inside of the device, called central line associated bloodstream infection (CLABSI).~     This infection generally requires hospital admission and antibiotic therapy. This treatment~     usually helps eradicate the infection but sometimes it is not possible to clear or it comes~     back after treatment. Also, once someone has had one line infection the chance of getting~     another one is higher. This study will test whether treatment and secondary prophylaxis of~     CLABSI with ethanol lock therapy (ELT) can significantly reduce the risk of treatment failure~     (comprising failure to clear initial infection, relapse or reinfection) in children and~     adolescents treated for cancer or hematologic disorders or undergoing hematopoietic stem cell~     transplantation (HSCT). ELT involves injecting a solution of ethanol and water into the line~     or port, allowing it to dwell for 2 hours, and then withdrawing the solution.~   "
159913|NCT01472952|"~     Sepsis remains a common entity in critical care patients with remarkable mortality. Despite~     extended research activities, no reliable bio-markers or scoring systems attributing the~     individual risk of developing sepsis have been found so far.~      Patients with multiple trauma are at high risk of developing sepsis. Due to local and~     systemic immune reactions, high plasma levels of known pro-inflammatory cytokines can be~     found.~      Simultaneously, certain anti-inflammatory reactions such as changes in immune cell activity~     and serum cytokine levels, known as compensatory anti-inflammatory response syndrome (CARS)~     take place.~      In addition to changes of cytokine levels and immune cell activity, underlying genetic~     reactions are present. For instance, expression of miRNA (as an potential important step of~     immune cell activation) is likely changed during systemic and local immune reactions.~      In the present study levels of pro- and antiinflammatory cytokines, a detailed assay of~     immune cell activation and the various expression of miRNA will be evaluated in patients of~     multiple trauma on day 1 and day 4.~      Additionally, clinical parameters of organ function, current infection markers as CRP and~     Procalcitonin, cardiovascular function such as Indocyanin clearance and hemodynamic measures~     delivered with PiCCO-system and heart rate variability will be assessed. Parameters of local~     tissue perfusion will be measured with transcutaneous laser doppler.~   "
159914|NCT01472939|"~     The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor~     agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in~     subjects with GERD who have persistent symptoms while on PPI therapy.~   "
159915|NCT01472926|"~     A pilot evaluation of tenecteplase compared to alteplase in acute ischaemic stroke patients~     currently eligible for intravenous alteplase treatment in a prospective, randomised, blinded~     outcome evaluation clinical trial using brain imaging as a biomarker.~   "
159917|NCT01472900|"~     Acne is one of the most common conditions that patients seek for help in dermatological~     clinic. Nowadays, conventional treatment including topical agents(retinoids, antibiotics~     ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a~     satisfying result but not to every patient. Some patients are not well respond to~     conventional therapy while some patients are unable to tolerate side effects of the~     treatments. Therefore, interventions to reduce acne are vigorously experimented . Lights and~     lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and~     infrared lasers have been found to be useful in treating active inflammatory acne.~     Although,pain ,downtime and poor response of comedonal acne are limitations of those lights~     and lasers therapy. 2940 nm Erbium:YAG laser which has both resurfacing and photothermal~     effects is our laser of interest to seek for its efficacy in the treatment of inflammatory~     acne.~   "
159918|NCT01472887|"~     Primary Objective:~      Participants achieving an Objective Response Rate~      Secondary Objective:~        -  Progression Free Survival~        -  Overall Survival~        -  Response Duration~        -  Safety~   "
159919|NCT01472874|"~     Hypothesis: The investigators postulate that patients with Wilson disease who are~     asymptomatic or who have been effectively treated for their symptoms and are in a maintenance~     phase therapy can be safely and effectively treated with a single daily dosage of the~     chelating agent trientine.~      Specific Aims: To demonstrate that a single daily treatment with trientine is as effective or~     better than a patient's current maintenance therapy. This will be accomplished by performance~     of a case control prospective study of patients on their prior therapy, and during a period~     of treatment with a single weight based dose regimen of trientine.~      The primary endpoint for this study is the demonstration of equivalence to a patient's prior~     therapy. Secondary endpoints include: 1) demonstration of stability or improvement in~     parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression of~     liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by~     Fibrotest).~   "
159920|NCT01472861|"~     The purpose of this study is to determine if the use of Autologous Endometrial Coculture~     (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves~     pregnancy outcome.~   "
159921|NCT01472848|"~     This study examines whether a gradual increase of dose improves the gastrointestinal~     tolerability (nausea and vomiting) of PF05212389~   "
159922|NCT01472835|"~     Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is~     well-documented that the reference standard for identifying a pain generator is a low-volume~     block performed with local anesthetic, with or without steroid. Many factors may increase the~     false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of~     sedation is the most controversial and remediable. Proponents of sedation argue that it has~     little effect on the rate of positive diagnostic blocks, and may even reduce the~     false-negative rate. The purpose of this study is to determine the effect of intravenous~     sedation on pain relief and the false-positive rate after diagnostic nerve blocks.~   "
159923|NCT01472822|"~     Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in elderly~     adults. Schizandra chinensis(Omija) has been known to have five predominant tastes: salty,~     sweet, sour, astringent, and bitter. It has also been shown to have various effects on the~     anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous system,~     endocrine system, and stress protect. Therefore, this study is designed to evaluate the~     efficacy and safety on KO of Omija extract.~   "
159924|NCT01472809|"~     The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2)~     the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to~     the body) in the healthy and diabetic subject.~   "
159925|NCT01472796|"~     In this research study, the goal is to find out if a currently FDA-approved medication called~     Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and~     improve heart function in the African American population. High blood pressure occurs earlier~     in life in African Americans, is more severe, and is associated with greater organ damage in~     relation to uncontrolled hypertension. Having low levels of Vitamin D is also very common in~     the African American population. Research has shown that there may be a link between low~     Vitamin D levels and the ability of high blood pressure medications to be fully effective.~   "
159926|NCT01472783|"~     The main purpose of this study is to investigate the effect of veliparib in ovarian cancer~     patients with known BRCA 1/2 mutations who do no longer respond to conventional chemotherapy.~   "
159927|NCT01472770|"~     The present study aims to investigate the efficacy and safety of the combination of~     capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic~     colorectal cancer.~   "
159928|NCT01472757|"~     The purpose of the study is to evaluate the clinical efficacy of three doses of VR506~     delivered via a new dry powder inhaler for the treatment of asthma.~   "
159929|NCT01472744|"~     The investigators propose to test the hypothesis that a six-month intervention of combined~     fitness and cognitive training in the form of dancing will have a significant positive effect~     on a variety of executive control and memory processes as well as brain structure and~     function as compared to a non-aerobic strength and balance control/comparison group.~     Additionally, these two groups will be compared to walking groups in which one of the walking~     groups will also be provided with a daily, liquid, milk-based nutritional supplement.~   "
159948|NCT01472497|"~     Insulin resistance is often complicated with hypertension. AGE and inflammation play~     important roles in insulin resistance. Some studies reported that pioglitazone, insulin~     sensitizer, is effective for patients with insulin resistance, however, the mechanisms are~     still unclear. The aim of this study to evaluate the effect of pioglitazone compared with~     glimepiride on AGE, inflammatory cytokines and cardiac markers (BNP and echo) in hypertensive~     patients during oral glucose tolerance test.~   "
159963|NCT01472302|"~     Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both like~     PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU~     patients. The investigators hypothesized that using ASV from the beginning of intubation can~     reduce the total duration of MV and LOS in the ICU when compared to conventional modes such~     as PCV+PSV~   "
159964|NCT01472289|"~     The purpose of this study is to evaluate the safety and efficacy of the concentrated~     autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia~     patients.~   "
159930|NCT01472731|"~     Brain tumors account for only 2% of all cancers but result in a disproportionate share of~     cancer morbidity and mortality. The five-year survival rates for the most common histologic~     subtypes, anaplastic astrocytoma and glioblastoma (glioblastoma multiforme, GBM), are 30% and~     10%, respectively.~      Drugs affecting transforming growth factor-β (TGF-β) might be of great interest for malignant~     glioma treatment. TGF-β is an oncogenic factor in advanced tumors where it induces~     proliferation, angiogenesis, invasion, and metastasis as well as suppresses the antitumoral~     immune response. In addition TGF-β and its TGF-β receptors, TβRI and TβRII, are overexpressed~     in GBMs. TGF-β signaling is involved in multiple steps of GBM development. GC1008 is an~     antibody that is capable of neutralizing TGF-β and may therefore offer a new treatment option~     for patients with malignant glioma.~      For therapeutic success, it may be essential for GC1008 to reach the target site, in this~     case located in the brain. We will be able to prove this with 89Zr-GC1008 PET imaging. This~     imaging method also allows quantification of the amount of GC1008 reaching the tumor.~      This study consists of 2 parts. In part 1, patients with a suspicion of a malignant glioma~     undergo an 89Zr-GC1008 PET scan before standard (surgical)treatment. In part 2, patients with~     relapsed malignant glioma will undergo an 89Zr-GC1008 PET scan and will be treated with~     GC1008 in a phase II study as there is no standard treatment for these patients.~      We hypothesize that GC1008 uptake in brain tumors can be visualized and quantified using the~     89Zr-GC1008 PET scan and GC1008 might offer a new treatment option for patients with relapsed~     malignant gliomas.~   "
159931|NCT01472718|"~     200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and~     having a high thrombotic burden at coronary angiography, defined as the presence of a~     thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main~     objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or~     manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with~     angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1)~     rate of complete ST-segment elevation resolution at 60 minutes after the end of the~     procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance~     imaging (DE-MRI) at 3 months after the index procedure.~      Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct~     transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.~   "
159932|NCT01472705|"~     This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with~     biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer~     through 3 years of follow-up.~   "
159933|NCT01472692|"~     High normal blood pressure, also called prehypertension, is a significant problem. High uric~     acid in the blood, the same thing that causes gout, may cause higher blood pressures. The~     investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood~     pressure and stiffness of the main blood vessels and see if lowering uric acid has any~     effect.~   "
159934|NCT01472679|"~     The purpose of this study is to evaluate whether body composition is associated with a higher~     risk of mortality in subjects ≥ 65 years.~   "
159935|NCT01472666|"~     Dairy food contains a large amount of long-chain saturated fat, which traditionally has been~     linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a~     more neutral role. Milk fat contains large amounts of medium-chain saturated fatty acids~     (MC-SFA), which may have beneficial effects on human health. In addition, milk proteins and~     in particular whey proteins have been shown to have a beneficial effect on glucose disposal~     as well as anti-inflammatory properties. Therefore dairy products have a potential role in~     the treatment of the metabolic abnormalities of metabolic syndrome (MeS). However, human data~     from intervention studies are lacking.~      Aims of this project is to explore and understand the influence on human health of both~     medium-chain saturated fatty acids from milk fat and bioactive milk proteins per se as well~     as their interaction and potential positive synergy on the MeS.~      The investigators hypothesize that whey protein and medium-chain saturated fatty acids~     improve insulin sensitivity, postprandial lipid metabolism, blood pressure and inflammatory~     stress in humans and that they possess preventive effects on the risk of developing CVD and~     type 2 diabetes mellitus (T2DM).~      A total of 64 people with MeS or abdominal obesity will be included. The design is a~     randomized double-blinded, controlled parallel diet-intervention trial.~      Subjects are assigned one of four experimental diets for 12 weeks. The diets consist of~     either a diet with low levels of MC-SFA + whey protein (LF + whey), a diet high in MC-SFA +~     whey protein (HF + whey), a diet high in MC-SFA + casein protein (HF + casein) or a diets~     with low levels of MC-SFA + casein protein (LF + casein). The subjects are advised how to~     integrate the test foods in their habitual diet, which also continues unchanged. The~     subjects' energy intake is matched so they are kept weight stable throughout the study.~   "
159936|NCT01472653|"~     The therapy of patients with locally advanced head and neck cancer will be adjusted to the~     grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e.~     either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy~     (radiotherapy and Cisplatin.~   "
159937|NCT01472640|"~     Type 2 diabetes (T2D) is a major risk factor of chronic heart failure (CHF). Glycemic control~     in patients with the combination of T2D and CHF is complicated and the currently available~     treatments have proven to be inadequate in clinical trials.~      Objectives To investigate the effect of Liraglutide compared to placebo on left ventricular~     ejection fraction (LVEF) in CHF patients with and without T2D.~      Multicenter, randomized, double blind study of 240 patients with documented systolic CHF (50%~     with T2DM) will be randomised. The effect of Liraglutide on left ventricular systolic and~     diastolic function will be evaluated by advanced echocardiography~      Primary outcome parameter is change in LVEF from visit 1 to week 24.~   "
159938|NCT01472627|"~     The purpose of this study is to better understand what effects Bortezomib, a drug used for~     multiple myeloma therapy, has on the immune system.~   "
159939|NCT01472614|"~     This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and~     safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile,~     and adiponectin in subjects with type-2 diabetes mellitus.~   "
159940|NCT01472601|"~     This study is a parallel translational study of a Randomized Phase III trial Investigating~     the Role of Oxaliplatin duration (6 Cycles Versus 12 Cycles) in modified FOLFOX-6 Regimen as~     Adjuvant Therapy for Patients with Stage II/III Colon Cancer (MIDAS trial: protocol~     NCCCTS-467) . Patients participating in the trial will be provided with the informed consent~     of this parallel study, and peripheral blood and tumor tissue of those who signed the consent~     will be collected for germline polymorphism analysis and gene expression profile study .~   "
159965|NCT01472276|"~     Web- or internet-based programs have the potential to induce and, possibly, help to sustain,~     significant lifestyle modification. This study will evaluate the effect of a unique~     interactive web-based behaviour change program on weight loss and cardiovascular risk factors~     in people who are overweight or obese and at high risk of cardiovascular disease.~   "
159941|NCT01472588|"~     Obesity is a significant and growing problem in the US that negatively impacts health and~     well-being of racial and ethnic minorities, people of low socioeconomic status, and persons~     living in rural communities and in the South. Obesity is a major concern in Arkansas, where~     the obesity rate for adults is higher than the rate for other adults in the nation. However~     effective weight loss programs are not typically available in these communities. Research has~     shown that the Diabetes Prevention Program (DPP) lifestyle intervention is effective in~     promoting weight loss in high risk individuals through changes in diet and physical activity~     that significantly reduce the chances of type 2 diabetes. Effective methods are desperately~     needed to translate the DPP to community settings, where obesity is a compelling public~     health burden. A major step in translating the DPP is to examine the efficacy of health~     professionals and community health workers (CHWs) in delivering the program in real-world~     settings. This is an important issue from the perspective of how evidence-based weight loss~     interventions can be provided to underserved, and resource constrained communities that~     typically may not have access to trained professionals for program delivery. The current~     project is a 5 year randomized controlled trial that examines DPP delivery and weight~     outcomes for individuals randomly assigned to either: (1) the DPP intervention delivered by~     CHWs or (2) the DPP intervention delivered by health professionals or (3) the Self Help~     condition. The study population consists of overweight adults (body mass index (BMI) > 25)~     who reside in communities with a high proportion of African Americans. Primary outcome is~     change in body weight at 16 months. Cost effectiveness and lifestyle behaviors are also~     evaluated.~   "
159942|NCT01472575|"~     This project aims to assess the impact of rotavirus vaccine introduction on severe~     gastroenteritis in South Australian children. Prevalence of rotavirus coded hospitalisations~     and all-cause gastroenteritis hospitalisations will be compared for a two year period prior~     to introduction of the vaccine and a two year period following introduction of the vaccine.~     Severity of rotavirus coded admissions during the periods will also be assessed.~      Hypotheses:~        1. Introduction of the rotavirus vaccine will result in an 80% reduction in~          hospitalisations for rotavirus positive gastroenteritis (ICD code A0.80) in children~          less than two years of age.~        2. Introduction of rotavirus vaccine will result in an 80% reduction in Paediatric~          Emergency presentations for rotavirus positive gastroenteritis in children under two~          years of age.~        3. Introduction of the rotavirus vaccine will result in a 50% reduction in hospitalisations~          for all cause gastroenteritis (ICD codes A0.00-A0.90) in children less than two years of~          age.~        4. Introduction of the rotavirus vaccine will result in a 50% reduction in Paediatric~          Emergency presentations for all cause gastroenteritis in children less than two years of~          age.~        5. Introduction of rotavirus vaccine will result in a reduction in hospitalisation and~          Paediatric Emergency presentations in children aged four and five years with rotavirus~          positive gastroenteritis (unvaccinated cohort).~        6. There will be no difference in severity of disease as scored by the Vesikari and/or~          clark severity score prior to and post introduction of rotavirus vaccine~   "
159943|NCT01472562|"~     This is a phase II, multicenter study to determine the efficacy and safety of first-line~     lenalidomide plus rituximab therapy in patients with mantle cell lymphoma who have received~     no prior systemic therapy.~   "
159944|NCT01472549|"~     The investigators propose a randomized controlled clinical trial to determine the comparative~     effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for~     preventing surgical site infections at cesarean section. While estimates vary, surgical site~     infections complicate up to 5 - 10% of all cesarean sections and result in significant human~     suffering and excess health care costs. Interventions such as preoperative antibiotic~     prophylaxis reduce surgical site infections by 60%, but the rate of infection remains high.~     There is therefore a great need to identify and test other potential interventions to further~     reduce these infections.~      The skin is a major source of pathogens that cause surgical site infection. Therefore,~     optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical~     site infections. There is paucity of evidence to guide the choice of antiseptic for skin~     preparation at cesarean section. To date, only two underpowered trials have been published~     comparing two methods of preoperative skin preparation at cesarean section. A recent~     randomized trial in adults undergoing clean-contaminated mostly general surgical procedures~     demonstrated a 41% reduction in surgical site infection with the use of chlorhexidine-alcohol~     when compared to the more commonly used povidone-iodine. While it is plausible that findings~     from trials in other clean-contaminated surgical procedures may apply to cesarean sections,~     physiological changes in pregnancy, the peculiar dual microbial source for cesarean-related~     infections and the hormone-mediated immune-modulation in pregnancy make the validity of such~     extrapolation uncertain.~      The study has the following specific aims:~      Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation~     at cesarean section significantly reduces surgical site infections compared to~     iodine-alcohol.~      Secondary Aim 1: To test the hypothesis that preoperative chlorhexidine-alcohol skin~     preparation at cesarean section significantly reduces bacterial contamination at the surgical~     site compared to iodine-alcohol.~      Secondary Aim 2: To determine clinical outcomes and medical costs associated with~     cesarean-related infections and quantify potential cost savings attributable to use of~     chlorhexidine-alcohol for preoperative skin preparation at cesarean section.~   "
159945|NCT01472536|"~     Much of community transmission of seasonal and pandemic influenza occurs in younger~     individuals, because of their susceptibility and their social interaction~     patterns.Universities are places where transmission of influenza is facilitated because of~     the age of individuals involved, their close contact with each other, and low vaccination~     coverage. Staying home when you are sick (i.e., voluntary sequestration) has been identified~     as one of the most efficient ways to reduce influenza transmission, but there are still~     insufficient data on the effects of social distancing to be able to make recommendations for~     future pandemics or even outbreaks of seasonal influenza.~      The investigators are conducting a study on the effect of voluntary sequestration during~     illness on the transmission of influenza among social networks in University residence~     housing units at the University of Michigan. The sequestration interventions will be carried~     out during a period of influenza transmission that is defined by surveillance conducted at~     the University Health Service. Data will be collected on use of the interventions and the~     occurrence of influenza and other illnesses. In all selected residence halls, specimens will~     be collected when illness meeting a case definition for influenza-like illness occurs.~      This study in a university population will evaluate the acceptability and magnitude of effect~     that can be expected from such an intervention, and determine the number of days that~     sequestration should be practiced.~   "
159946|NCT01472523|"~     A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the~     presence of trisomies using a novel method.~   "
159947|NCT01472510|"~     This study is designed to confirm that the investigational drug Ranibizumab given by~     injection into the eye is safe and effective to use in people with diabetic macular edema~     (DME).~   "
159996|NCT01471873|"~     Primary objective of this study was to assess the intrasession, intersession and~     interobserver variability of the Pentacam-derived posterior corneal elevation measurements in~     keratoconus eyes and eyes that underwent Corneal Collagen Cross-liknking (CxL) treatment due~     to progressive keratoconus.~   "
159949|NCT01472484|"~     Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have~     the potential to alleviate iron bioavailability problems associated with PA. These plants~     have normal phosphate levels, but reduced PA phosphate due to various modifications of the~     biosynthetic pathway of PA. So far lpa crops are in an early stage of development, most of~     them exhibiting reduced yield and seed germination. However, the lpa bean isolated by Campion~     and co-workers 2009 by chemical mutagenesis exhibited only 10 % of the native bean PA~     concentration without any defects in terms of growth and yield.~      Crossing the lpa variety with bean varieties low in PP and high in iron might lead to the~     development of a variety which has the potential to improve the iron status of bean consuming~     populations.~      The following study will evaluate the relative impact of PA and PP on iron absorption from~     beans by comparing iron absorption from four different bean varieties. Iron absorption from a~     bean with normal PA concentration and high PP concentration will be compared to iron~     absorption from a bean with normal PA and low PP concentration as well as to two lpa~     varieties, one with high and one with low PP concentration.~   "
159950|NCT01472471|"~     Oxidative stress is seen in children with asthma, but is hard to measure. The investigators~     exploring the utility of using a commercially available assay to measure oxidative stress in~     the urine in asthmatics. Additionally, the investigators will attempt to prove that oxidative~     stress is higher in children with acute asthma compared to those with stable asthma and that~     this stress is also higher in children with more severe clinical asthma exacerbations~     compared to less severe ones.~   "
159951|NCT01472458|"~     The study Premature Termination of Resuscitation in Survivors of Cardiac Arrest focuses on~     using innovative knowledge translation strategies to improve appropriate neuroprognostication~     for survivors of cardiac arrest and prevent premature termination of life sustaining~     therapies. This is important because any early gains achieved during resuscitation will be~     nullified if clinicians terminate life-sustaining therapies prematurely based on inadequate~     prognostic information. An effective translation strategy for neuroprognostication will~     result in improved physician adherence to evidence-based medicine and an increase in the~     proportion of patients surviving to achieve a good neurological outcome following cardiac~     arrest.~   "
159952|NCT01472445|"~     This is a research study of the effect of Vitamin D on breast cancer. We hope to learn~     whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that~     affect its growth. We believe some of these characteristics may be influenced by body weight.~   "
159953|NCT01472432|"~     A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4~     months of vildagliptin on healing of chronic ulcers in type 2 diabetes.~   "
159954|NCT01472419|"~     Esophageal squamous cell carcinoma is considerably more prevalent in East Asia. Despite of~     relatively high prevalence of esophageal SCC, prognosis is very poor with limited options of~     effective chemotherapy regimens. We attempted to identify favorable subgroups of patient who~     are likely to benefit from 5- fluorouracil/cisplatin(FP) or capecitabine/cisplatin (XP)~     chemotherapy as first-line treatment.Between January 2000 to December 2010, 239 patients were~     diagnosed of recurrent, metastatic esophageal SCC and received either FP or XP as first-line~     chemotherapy. Clinicopathologic variables and treatment outcome were retrospectively~     collected. we analysis treatment outcome of palliative chemotherapy in metastatic esophageal~     squamous cell carcinoma and make prognostic scoring system. The present study represents the~     largest series to analyze the treatment outcome of FP/XP chemotherapy in metastatic SCC.~     Risk-adapted stratification of treatment for subgroup of metastatic SCC patients should be~     actively pursued.~   "
159955|NCT01472406|"~     This clinical trial is a feasibility study to assess the performance of an Artificial~     Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with~     type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San~     Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring System~     (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP device is~     controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a safety~     algorithm named the Health Monitoring System (HMS). The clinical study will include 12 to 20~     adults subjects aged 21 to 65 years old.~   "
159956|NCT01472393|"~     Animal, in vitro and small-scale studies have suggested that creatine supplementation may~     augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine~     supplementation protocol on bone mass in postmenopausal women.~   "
159957|NCT01472380|"~     Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an~     inhibitor of CYP2B6. This study will evaluate the effect of multiple doses of fenofibric acid~     at steady-state on the pharmacokinetics of single-dose efavirenz in healthy adult subjects.~   "
159958|NCT01472367|"~     The purpose of the study is to assess the safety of the addition of sitagliptin, and its~     effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients~     requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with~     type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy (alone~     or in combination with insulin). The primary hypothesis is that the addition of sitagliptin~     reduces A1C more than the addition of placebo after 20 weeks of treatment. Participants who~     complete the 20-week base period of the study may choose to participate in the extension~     period of the study and continue on or off treatment assigned during the base period for an~     additional 34 weeks.~   "
159959|NCT01472354|"~     The purpose of the LEAP-C (learning, experiencing and preparing for hepatitis C treatment)~     study is to see if a brief (4-week) small group intervention will help people with HIV/HCV~     co-infection make an informed decision about Hepatitis C treatment.~   "
159960|NCT01472341|"~     The purpose of this study is to evaluate the degree of beta-cell dysfunction among~     participants with type 2 diabetes and the association between beta-cell dysfunction and~     demographic, clinical, and treatment variables.~   "
159961|NCT01472328|"~     Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin~     sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in patients.~   "
159962|NCT01472315|"~     The purposes of this study are to evaluate the degree and duration of medroxyprogesterone~     acetate effect as well as tolerability in postmenopausal women with nasal continuous positive~     airway pressure (CPAP) treated sleep apnea and to compare the effects with nasal CPAP.~   "
159966|NCT01472263|"~     In this study the investigators are going to evaluate the efficacy pentoxifyline in HTLV-1~     patients with neurological diseases: HAM/TSP or neurogenic bladder. In some laboratory~     experiments the investigators observed that this drug had the capacity to reduce the immune~     response in HTLV-1 infected cells. Since the exacerbated immune response is know to cause~     neurological disease in patients with HTLV-1 the investigators hope that pentoxifyline can~     alleviate symptoms and delay the progress of HAM/TSP in patients.~   "
159967|NCT01472250|"~     This is a multi-center, prospective and observational clinical study. Eligible patients will~     accept generalized chemotherapy according to the investigator's assessment. Information~     related to the treatment, including medication, disease condition, expenses, etc. will be~     periodically collected. Follow-up at 2-month intervals will be periodically performed to~     continually collect information about the disease progression, subsequent treatment and~     survival until death or completion of the study.~      Recruited patients will fill out questionnaires about quality of life before initiation of~     treatment, at Cycle 3 and completion of first-line treatment.~   "
159968|NCT01472237|"~     The purpose of this study is to determine whether a modification of the diet of malnourished~     patients admitted for heart failure is beneficial in term of mortality,hospitalizations and~     quality of life.~   "
159969|NCT01472224|"~     This study investigates the ability of ultrasound to measure the volume of a brain hemorrhage~     in the acute phase after hospital admission.~      It is known that approximately 30% of patients admitted with a brain hemorrhage will suffer~     from enlargement of the hematoma within the first hours after admission.~      In this study the investigators measure the volume of the hematoma every 30 minutes up to 6~     hours after admission and every 2 hours between 6-12 hours.~   "
159970|NCT01472211|"~     The overall aim of this trial is to determine whether the use of the household-based water~     treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status~     and health status of vulnerable populations in developing country rural settings with poor~     access to potable water.~      To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc~     enriched water) a double blind controlled field efficacy trial will take place over a period~     of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to~     attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc~     enriching filter), placebo (filter) and control group (disinfection tables). During the trial~     the following outcomes will be monitored: zinc status and growth rate of the participating~     children, zinc status and pregnancy outcome in a sub-sample of pregnant women (pregnancy~     sub-study), diarrhea prevalence in all participating subjects, water quality, zinc enrichment~     of water, and modality and consistency of use of the LSF-device by the study population.~      The study hypotheses are: 1) the use of the LSF-device will reduce microbiological~     contamination of the household water, 2) the use of the LSF-device will increase zinc intakes~     and serum zinc concentration in preschool children, 3) the use of the LSF-device will~     increase zinc intakes and serum zinc concentration in pregnant women, 4) the achievement of 1~     and 2 will improve growth and lower frequency and length of diarrhea episodes in~     participating preschool children, 5) the achievement of 1 and 3 will improve pregnancy~     outcome and lower frequency and length of diarrhea episodes in participating pregnant women,~     6) the use of the LSF-device will lower frequency and length of diarrhea episodes in~     participating households members.~   "
159971|NCT01472198|"~     This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination~     with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be~     comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment~     phase.~   "
159972|NCT01472185|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to~     determine the effect of ranolazine when given as monotherapy on glycemic control in subjects~     with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise~     alone and who are treatment naive to antihyperglycemic therapy or have not received~     antihyperglycemic therapy in the 90 days (or thiazolidinediones [TZDs] for at least 24 weeks)~     prior to screening, and to characterize the relationship between HbA1c reduction and other~     glycemic parameters in subjects with T2DM.~   "
159973|NCT01472172|"~     The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe~     during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding~     intensity.~   "
159974|NCT01472159|"~     The purpose of this 2-year randomized controlled trial (RCT) is to implement and evaluate a~     family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained~     continuous glucose monitoring (CGM) use in youth with type 1 diabetes (T1D). We hypothesize~     that CGM implemented with a family-focused, behavioral teamwork intervention will result in~     sustained CGM use and greater improvement in A1c compared to routine implementation of CGM.~   "
159975|NCT01472146|"~     The purpose of this study is to evaluate the association of zoledronic acid with standard~     treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast~     cancer HER 2 positive.~   "
159976|NCT01472133|"~     Continuous accurate unobtrusive respiratory rate monitoring may lead to improved patient~     outcomes, as respiratory rate is thought to be a sensitive marker of patient deterioration.~     Currently systems are not suitable for long term monitoring, particularly in ambulant~     patients as they are too restrictive. To ensure that our algorithms are suitable for use in a~     clinical context we need to demonstrate their performance not only in the optimal situation,~     healthy volunteers at rest, but also in more challenging situations such as where the person~     being monitored is moving and also in patients who have conditions which may affect their~     physiology in such a way that the accuracy of the respiration rate estimation may be~     affected.~      No previous study has systematically tested algorithms deriving respiratory rate from either~     the ECG or the photoplethysmography (PPG) waveforms in a real -world setting.~      The algorithms work by looking for changes in intervals between heartbeats and also changes~     in the sizes of the ECG and PPG waveforms, both of which may be caused by respiration. These~     changes tend to diminish with increasing age and also conditions which alter the chest~     movement and cardiac reflexes. Thus it is important to test our algorithms' accuracy in~     participants exhibiting these conditions. It is also important to ensure that the~     calculations of respiratory rate are accurate across a range of heart rates and respiratory~     rates. Our testing covers all these variables.~   "
159977|NCT01472120|"~     In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1~     and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in~     various metabolic disorders such as obesity and type 2 diabetes mellitus.~   "
159978|NCT01472107|"~     The GIMEMA FOUNDATION promotes an observational (retrospective) study on number and outcome~     of pregnancy in childbearing age female patients treated with chemotherapy for APL. These~     patients were enrolled in studies AIDA0493, AIDA2000 and were in CR.~   "
159997|NCT01471860|"~     The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx~     Barostim Neo System in the treatment of patients with heart failure.~   "
159979|NCT01472094|"~     The goal of this study is to develop a bedside to bench model of clinical and biological~     predictors for toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast~     cancer. The investigators will develop a predictive model using clinical and biological~     predictors of toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast~     cancer. The investigators will also determine the association between clinical and biological~     factors and reduced relative dose intensity of the prescribed chemotherapy regimen. In~     addition, the investigators will explore specific chemotherapy toxicities associated with~     reduced relative dose intensity of a prescribed regimen.~   "
159980|NCT01472081|"~     The purpose is to determine the safety, effectiveness and best dose to use when giving~     Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of~     metastatic renal cell carcinoma.~   "
159981|NCT01472068|"~     This is a pilot clinical study taking place at one site in Berlin, Germany using~     Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of 20 women~     suffering from stress urinary incontinence. This involves a 12 week, 30 minute, 5 days out of~     7 set treatment program with the device. After the 12 week treatment programme the subjects~     will be asked to perform daily set exercises for a further 14 weeks.~   "
159982|NCT01472055|"~     The purpose of this study is to analysis of the pharmacokinetics of fludarabine for~     hematopoietic stem cell transplantation in pediatric patients.~   "
159983|NCT01472042|"~     The purpose of this study is to study the biomarkers in subjects before and after~     sports-induced traumatic brain injury. The assay will be studied in a sample population of~     subjects over the age of 18 participating in college sports.~   "
159984|NCT01472029|"~     The purpose of this study is to determine the rate of complete pathological responses~     (percentage of patients with pCR referring to the total number of enrolled and eligible~     patients), as evaluated centrally by a reference pathologist.~   "
159985|NCT01472016|"~     This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and~     preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET~     amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications,~     is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the~     activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.~   "
159986|NCT01472003|"~     This is an open label study designed to evaluate the biodistribution and imaging~     characteristics of ABT-806i (111In-ABT-806) in subjects with advanced solid tumor types.~   "
159987|NCT01471990|"~     The purpose of this study is to examine and compare the effect of pituitary adenylate~     cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on~     intracranial arteries and neuronal activity in patients with migraine without aura using a~     high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and~     functional MRI (fMRI).~      MRA will be used to detect changes in intracranial artery circumferences before and after~     PACAP38 and VIP.~      fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal~     (BOLD-signal).~      PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific~     drug sumatriptan will be given to relieve pain and the effect will also be registered using~     MRA and fMRI.~   "
159988|NCT01471977|"~     It was hypothesized that tuberculosis patients receiving multiple interventions like~     educations, counseling and default tracing along with DOTS were more likely to adhere to~     tuberculosis treatment as compared to few interventions or DOTS only.~   "
159989|NCT01471964|"~     This phase I/II trial studies the side effects and the best dose of MLN8237 when given~     together with erlotinib hydrochloride and to see how well it works in treating patients with~     recurrent locally advanced or metastatic non-small cell lung cancer (NSCLC). MLN8237 and~     erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
159990|NCT01471951|"~     Embryo selection based on the use of morphometric parameters should increase the implantation~     success rate.~      One of the most important issues of Assisted Reproduction Technologies (ART) is the~     possibility of multiple pregnancies which carries a significant risk for maternal-fetal~     health. These risks can be reduced by restricting the number of embryos transferred.~      To do this, it is essential to improve current techniques of embryo selection by developing~     new tools that would allow the selection of the embryos with higher implantation potential.~     In previous works (Molina et al 2011) the investigators have demonstrated greater efficacy~     for the embryo classification systems based on the use of the morphometric variables. The~     investigators have also developed a profile of embryo implantation using these morphometric~     variables. In this project the investigators intend to validate the clinical validity of this~     new embryo classification system by conducting a prospective study of single embryo transfer~     (SET) in young women at risk of multiple pregnancies.~   "
159991|NCT01471938|"~     The aim of the study is to apply and adapt device specific body composition formulas to~     various ethnic groups. Bases are prediction equations that are generated in the clinical~     investigation Generation of prediction equation to analyze body composition of adults based~     on Bioelectrical Impedance Analysis (BIA). The study bears the code BCA-01.~   "
159992|NCT01471925|"~     A phase III, randomized, open-label, superiority study comparing the incremental product~     esomeprazole associated with sodium bicarbonate made by Eurofarma and Nexium® in the~     treatment of gastroesophageal reflux disease. The study will enroll 94 patients in each arm~     (total of 188 patients).~   "
159993|NCT01471912|"~     In our experience, elongation of foveal tissue after macular hole surgery which was~     undetectable by conventional time-domain optical coherence tomography was often observed on~     spectral-domain optical coherence tomography images. Elongation of tissues inevitably induces~     some degree of disorganization of tissue microstructure.~      The purpose of the present study was to evaluate elongation profile of foveal tissue after~     macular hole surgery and to investigate its impact on visual acuity and metamorphopsia.~   "
159994|NCT01471899|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drugs in the treatment of patients diagnosed with moderate to severe back pain~     treatment.~   "
159995|NCT01471886|"~     The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two~     different drugs in the treatment of patients diagnosed with moderate to severe back pain.~   "
159998|NCT01471847|"~     This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients~     that have locally advanced or metastatic HER2+ breast cancer. The first part (phase Ib) will~     investigate the MTD/ RP2D of the combination therapy of BEZ235 BID and weekly trastuzumab~     using a Bayesian model. Once MTD/ RP2D is established the second part (phase II) will start.~     Phase II will evaluate the efficacy and the safety of weekly trastuzumab plus BEZ235 BID~     compared to capecitabine and lapatinib.~   "
159999|NCT01471834|"~     The purpose of this clinical investigation is to verify the efficacy and safety of the CVRx~     BAROSTIM NEO System in the treatment of resistant hypertension.~      The study is currently in long-term follow-up and will continue to follow subjects in order~     to systematically and actively ascertain the type, frequency, severity and timing of~     long-term adverse events in subjects implanted with the device, while providing a viable~     treatment option to patients currently implanted with CVRx's BAROSTIM NEO System.~   "
160000|NCT01471821|"~     This is a prospective, open controlled trial in which HIV-1 with viral suppression patients~     will be randomized to continue with their current treatment (lopinavir/ritonavir plus~     emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or~     to simplify to lopinavir/ritonavir plus lamivudine.~      Randomization will be stratified according to the values of nadir CD4 and time of viral~     suppression.~   "
160001|NCT01471808|"~     The purpose of this study is to investigate and evaluate the effects of different oral~     antihyperglycaemic agents combined with short-term continuous subcutaneous insulin~     infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin~     combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type~     2 diabetic patients.~   "
160002|NCT01471795|"~     Infections often occur after ventricular assist devices (VADs) are placed. These infections~     can be very serious. The goal of this study is to understand why these infections occur.~     Bacteria (germs) normally live on our skin and in our noses. After surgery, they can infect~     the VAD. The investigators will collect cultures of your skin and nose before and after~     surgery. The investigators will compare these bacteria to bacteria that cause infections.~     Their genes will be compared to see which ones help the bacteria cause infection.~   "
160003|NCT01471782|"~     The purpose of this study is to determine the dose of the bispecific T cell engager~     blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute~     lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.~   "
160004|NCT01471769|"~     The purpose of this study is to evaluate if an educational video viewed during the Emergency~     Department visit will improve parent knowledge of pain management, reduce parent anxiety, and~     change their use of analgesics at-home after discharge from the Emergency Department.~   "
160005|NCT01471756|"~     The investigators seek to compare two techniques of removing pre-cancerous lesions from the~     colon. The investigators also will compare two solutions used during the procedure to~     determine if either solution allows for an improved removal of the tumors.~   "
160006|NCT01471743|"~     Surgical patients are high risk for post operative infections. These post operative~     infections contribute to increased length of hospital stay, hospital costs and delay overall~     recovery time thus decreasing the quality of life. Studies have reported post operative~     complications ranging from 37% to 74%.1 The most costly complications include infectious~     complications after major Gastrointestinal (GI) surgery including wound infections, abdominal~     abscess, pneumonia, sepsis and anastomic leaks.2 Several studies have been conducted that~     show a significant reduction in infectious complications and average length of stay when~     treated with immunonutrition supplements.2-3 A review of similarly designed studies in a~     different patient population indicate that post-operative infections can be reduced by an~     average of 71% with immunonutrition.~      This study seeks to investigate the effect of Impact Advanced Recovery ® in improving~     surgical outcomes in patients receiving major gastrointestinal surgeries compared to a~     standard supplement at James A. Haley Veterans' Hospital. Providing Impact Advanced Recovery~     ® may decrease post-operative infectious complications, length of stay, and recovery time.~      Hypothesis~        1. In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic~          or colon resections) there will be a significant decrease of at least 60% in~          post-operative infections as listed below for patients who consume 15 servings of Impact~          Advanced Recovery® pre-operatively compared to patients who consume 15 servings of a~          standard supplement.~           Complications to be considered: anastomatic leak, post-op wound development, post-op~          abdominal abscess, sepsis, pneumonia, post-op ileus, intestinal fistula, obstruction,~          urinary tract infections, peritonitis or bowel necrosis.~        2. In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic~          or colon resections) there will be a significant decrease in hospital and NPO days for~          patients who consume 15 servings of Impact Advanced Recovery ® pre-operatively.~   "
160007|NCT01471730|"~     Prospective, randomized, double blind trial. The rationale of the study is the concept that~     fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that~     prothrombin complexes and fibrinogen are available.The experimental hypothesis is that~     cardiac surgery patients may be operated with no use of FFP and with a coagulation factors~     replacement based on fibrinogen and prothrombin complexes (when needed).~      Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive~     blood transfusion, bleeding.~      Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60~     patients each~   "
160008|NCT01471717|"~     This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction~     between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).~   "
160009|NCT01471704|"~     The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug~     interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL~     ER).~   "
160010|NCT01471691|"~     This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular~     edema secondary to retinal vein occlusion in patients that have previously failed treatment~     with other macular edema treatments including bevacizumab.~   "
160011|NCT01471678|"~     This study aims to determine the relative bioavailability of tamsulosin hydrochloride in a~     fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg)~     relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.2~     mg tablets or capsules. Two fixed dose combination capsules will be tested; one will contain~     tamsulosin hydrochloride pellets with a 15% enteric coating, and the other tamsulosin~     hydrochloride pellets with a 10% enteric coat. In addition, two formulations of tamsulosin~     hydrochloride will be tested in the co-administration with dutasteride 0.5 mg; a 0.2 mg oral~     disintegrating tablet and a 0.2 mg hard shell capsule. This will be an open-label,~     randomized, single dose, four-period crossover in healthy male subjects of North East Asian~     ancestry. Subjects will receive single oral doses in four treatment periods, each separated~     by a 5-10 day washout period. Blood samples for pharmacokinetic analysis will be taken at~     regular intervals after dosing. Safety will be assessed by measurement of blood pressure,~     heart rate and review of adverse events. The study will enrol approximately 30 healthy male~     subjects to ensure that 24 complete the study.~   "
160012|NCT01471665|"~     The purpose of this study is to investigate the effect on repeat doses of GSK2190915 in~     asthmatic patients with a high percentage of neutrophils in their sputum. GSK2190915 will be~     given as an add on to current therapy, and its effects on the percentage of sputum~     neutrophils in the patients will be assessed.~   "
160013|NCT01471587|"~     Skeletal muscle is composed of two fibre types which are intertwined. Skeletal muscle~     weakness, particularly of the walking muscles, is an important complication of Chronic~     Obstructive Pulmonary Disease (COPD) but so far the investigators do not know what mechanisms~     drive the process.~      All existing studies have investigated signalling pathways in the whole muscle so they have~     been forced to consider type I and type II fibres together. It is possible that disease~     selectively affects one fibre type, most likely type I fibres which are in fact lost in COPD~     patients. For this reason mechanisms of disease may have been overlooked by current studies.~      The applicants have acquired the technology which allows type I and type II fibres in a~     muscle specimen to be split (by laser capture microdissection) and so signalling pathways can~     be assessed separately in type II and type I fibres which is what this proposal sets out to~     do.~      The proposal therefore aims to capture well characterised clinical data from 60 COPD patients~     and 20 age matched controls, from whom a biopsy of the main walking muscle, the quadriceps,~     will be taken. In the samples the investigators will assess at a fibre specific level~     inflammatory signalling. Surplus material will be retained for subsequent fibre specific~     analysis.~   "
160014|NCT01471561|"~     This is a retrospective study to determine if rates of osmolarity and dry eye disease~     symptoms increase following cataract surgery.~   "
160015|NCT01471548|"~     The purpose of in this study is to assess the safety profile and estimate the maximum~     tolerated dose of TKI258 in Japanese patients.~   "
160016|NCT01471431|"~     The objective of this study is to determine whether use of the spontaneous breathing trial~     allows for earlier successful extubation of very low birth weight (VLBW) infants who are~     intubated for >48 hours and have not yet been successfully extubated (extubated >7 days).~   "
160017|NCT01471418|"~     Temporomandibular joint disorders (TMD) are a common musculoskeletal problem with an~     estimated 40-75 percent of the population reporting at least one sign. Up to fifteen percent~     of the patients who seek care for one of these conditions, will go on to develop chronic~     pain. The two most common TMD conditions include myofascial pain disorder and internal~     derangement of the Temporomandibular Joint (TMJ). These two conditions have similar clinical~     presentations, making an accurate diagnosis difficult. Currently, there is no accurate exam~     or test to differentiate between these two conditions.~      Internal derangement of the TMJ is a condition with disk displacement, pain, and dysfunction,~     which may progress to localized osteoarthritis. Fortunately, this condition is self-limiting~     for the majority of the patients afflicted, with a small minority progressing to advanced~     joint destruction, disability and chronic pain.18 Currently there are no prognostic~     indicators to identify these individuals. There are three hypothesis of degenerative TMJ~     disease, they include: direct mechanical trauma, hypoxia reperfusion injuries, and neurogenic~     inflammation. All involve parafunctional habits such as clenching or grinding by the patient~     and a low-grade inflammatory response/synovitis. 18-fluorodeoxyglucose (18-FDG), a~     radioisotope used with positron emission tomography (PET) and paired with a CT scan (PET/CT),~     may have a role in imaging inflammation in arthritis as recently demonstrated in several~     pilot studies involving osteoarthritis of the knee and shoulder. 18-FDG accumulates in areas~     of increased metabolism, particularly activated leukocytes, as measured by increased~     standardized uptake value.2 PET/CT offers the unique advantage of showing active disease~     before anatomic damage is evident. Our hypothesis is that there is an increased uptake of~     18-FDG on PET/CT in synovitis of the TMJ.~   "
160018|NCT01471379|"~     Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for~     treating irritable bowel syndrome (IBS) in women.~      Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS.~      Procedures: This study will observe patients treated with Savella® as well as patients~     treated with a placebo (pill with no active drug). The investigators will monitor and compare~     several patient and symptom related outcomes, as well as evaluate health related quality of~     life, psychological distress and related psychosocial measures to determine if the addition~     of Savella® improves clinical pain response as well as secondary outcomes including quality~     of life.~   "
160019|NCT01471366|"~     Many patients complain of fishy breath, upset stomach, or heartburn when taking the~     recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the~     fish oil capsules to help decrease adverse gastrointestinal effects. Compliance with~     over-the-counter (OTC) fish oil is a concern considering the high number of capsules taken~     daily. The hypothesis of this study is that taking fish oil with milk will help lead to~     better patient compliance with no difference in adverse effects versus other administration~     methods.~   "
160020|NCT01471353|"~     Combining Sorafenib with standard cytotoxic fluoropyrimidine therapy for advanced colorectal~     cancer may provide clinical benefit when no other treatment remains.~   "
160021|NCT01471340|"~     The purpose of this study is to test the safety of DULERA. DULERA is a pressurized~     metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol~     in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the~     inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps~     to relax the muscles of the airways in the lungs, making it easier to breathe. In~     combination, mometasone and formoterol are used for the treatment of asthma. This study will~     evaluate whether participants taking a LABA in combination with an ICS in a single inhaler~     have a different risk of having serious asthma events (hospitalization, intubation and death)~     compared to participants taking an ICS alone. The primary safety hypothesis is that the~     time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI~     twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents~     and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety~     hypothesis of superiority of MF/F over MF will be assessed.~   "
160031|NCT01471496|"~     The purpose of this study is to determine whether prophylactic injection therapy reduces~     recurrent bleeding rate for duodenal ulcers which has the endoscopic stigmata of recent~     bleeding.~   "
160094|NCT01470586|"~     Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups~     for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for~     RNA peroxidation)in patients with colorectal cancer undergo surgical treatment~     (preoperatively during the intervention and postoperatively) and controls.~   "
160095|NCT01470573|"~     Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to~     corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using~     cell culture technics that could permit the biological replacement of damaged ocular surface.~   "
160022|NCT01471652|"~     The pathogenesis of chronic fatigue syndrome (CFS) is poorly understood and no effective~     therapy has been developed. Recent studies suggest that a preceding viral infection causes~     mitochondrial dysfunction of the brain and skeletal muscle of genetically susceptible~     individuals. There is no specific laboratory test to identify patients with CFS. However,~     certain clinical manifestations are similar to those seen in mitochondrial disorders. Both~     patients with mitochondrial disorders and CFS manifest elevated serum lactate levels after~     exercise, and demonstrate elevated brain cerebrospinal fluid levels and decreased brain~     glutathione levels on nuclear magnetic resonance (NMR) spectroscopy.~      Therapy consisting of daily conditioning exercise, dietary recommendations, and nutraceutical~     supplements (ENT) has been show to be beneficial in treating patients with mitochondrial~     disorders. Similar therapy has been instituted in individual patients with CFS and has been~     shown to also improve their clinical conditions.~      A placebo-controlled trial will be undertaken in 24 CFS patients aged 25-55. Patients~     fulfilling the CDC criteria for CFS will participate in this 6 month study. Other medical~     causes for fatigue will be excluded. Half the patients will receive treatment consisting of~     daily conditioning exercise plus nutraceutical supplements (ENT), that has been shown to be~     beneficial for patients with mitochondrial dysfunction, while the other half will receive~     daily conditioning exercise and placebo tablets. Response to ENT will be evaluated by maximum~     oxygen consumption (VO2max) and circulating lactate levels during & after treadmill exercise,~     a 6-minute walk test, and a fatigue questionnaire. In addition, whether ENT corrects the~     elevated brain cerebrospinal fluid levels and decreased brain glutathione levels will be~     measured. To ensure compliance to therapy patients will be monitored frequently. The~     objective of this study is to assess the safety and efficacy of ENT and whether ENT leads to~     sustained improvement of CFS patients compared to their baseline status, and compared to an~     exercised group of patients not receiving supplements.~   "
160023|NCT01471639|"~     The purpose of this study is to determine the effectiveness, the safety, and the tolerability~     of intranasal ketorolac (Sprix) in relieving acute pain in adults ages 18-65 who come to the~     ED seeking care. Considering all ED visits, pain is the most common chief complaint. Giving~     intranasal ketorolac (Sprix) after stomach and dental surgeries has been shown to be safe and~     effective, but no studies have investigated the use of intranasal ketorolac (Sprix) for the~     treatment of acute pain in the ED.~      Ketorolac (Sprix) has several advantages over other drugs commonly given for pain, including~     opioids. Ketorolac (Sprix) is non-addicting and has fewer side effects than opioids. The~     administration of ketorolac (Sprix) by other methods, such as IV, intramuscular shot, and~     oral pill form, has been shown to be safe and effective in treating acute pain.~      This study is being done to find out if giving ketorolac (Sprix) as a single dose nasal spray~     will have the same benefit in decreasing patient's pain.~   "
160024|NCT01471626|"~     The purpose of this study is to develop an efficient home-based polysomnography device, which~     allows, through GPRS,continuous real-time monitoring from the sleep lab based in the~     hospital, in order to decrease the failure rate of home-based recordings.~   "
160025|NCT01471613|"~     The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical~     cord blood mononuclear cell transplant, and the combination in the treatment of acute and~     subacute spinal cord injury~   "
160026|NCT01471600|"~     In several national anaesthesia societies, clear fluids are allowed up to 2 hours before~     general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting~     remains routine. Recently, surgical studies proved that pre-operative carbohydrate-rich drink~     reduces preoperative discomfort without affecting gastric fluid volume and acidity.The aim of~     this study was to show the effects of preanaesthetic oral fluid in patients undergoing upper~     endoscopy without emergency. The expected efficacy is a reduction of the preoperative~     discomfort. The investigators thus propose a randomised prospective open-label study to~     assess efficacy of preanaesthetic oral glucose drink in patients undergoing upper endoscopy~     without emergency. Study compare two groups : group drink (200 ml of fruit juice without~     pulp ± 200 ml of coffee or tea, 2 at 4 hours before the induction of anaesthesia) and group~     overnight fasting.Discomfort was measured at 2 hours before GA (H-2), just before GA (H0)~     and 4h after anaesthesia (H+4). Each item (anxiety, thirst, hunger, nervousness, tiredness,~     nausea) was estimated by visual analogue scale (VAS from 0 to 100mm) and handgrip strength by~     dynamometer. Gastroenterologist assessed the quality of endoscopy (VAS), gastric residual~     fluid and acidity.The main aim of this study was to assess in patients referred for upper~     endoscopy under general anaesthesia, the effect of carbohydrate drink on preanaesthetic~     discomfort. Secondary purpose were to compare quality of endoscopy, residual gastric volumes,~     gastric acidity and incidence of side effects. 118 patients will be included in the study. A~     stratification will be made on the type of endoscopy.~   "
160027|NCT01471574|"~     The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir~     plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients~     coinfected with HIV~   "
160028|NCT01471535|"~     Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of~     chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive~     carriers.~      The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface~     antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine~     aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who would~     not generally be considered candidates for therapy.~   "
160029|NCT01471522|"~     The purpose of the ISCHEMIA trial is to determine the best management strategy for~     higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter~     randomized controlled trial with 5179 randomized participants with moderate or severe~     ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was~     performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude~     participants with either significant unprotected left main disease (≥50% stenosis) or those~     without obstructive CAD (<50% stenosis in all major coronary arteries). Of 8720 participants~     enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or~     another exclusion criterion, did not go on to randomization. Eligible participants were then~     assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed~     by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON)~     of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT.~      SPECIFIC AIMS~      A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial~     invasive strategy of cardiac catheterization followed by optimal revascularization, if~     feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular~     death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for~     unstable angina or heart failure in participants with SIHD and moderate or severe ischemia~     over an average follow-up of approximately 3.5 years compared with an initial conservative~     strategy of OMT alone with catheterization reserved for failure of OMT.~      B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy~     compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2)~     angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire Angina~     Frequency and Quality of Life scales; 3) all-cause mortality; 4) net clinical benefit~     assessed by including stroke in the primary and secondary composite endpoints; and 5)~     individual components of the composite endpoints.~      Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac~     catheterization Phase: Phase III~      Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous~     Coronary, other catheter-based interventions Phase: Phase III~      Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III~   "
160030|NCT01471509|"~     The purpose of this study is to determine the effect of various foods and/or food substances~     such as fats or proteins on the blood glucose and insulin concentrations in people with and~     without type 2 diabetes.~   "
160032|NCT01471483|"~     Older woman with ovarian cancer have a worse prognosis compared to younger patients. However,~     the reason is not known. Currently, the standard of care is to evaluate younger and older~     patients with cancer the same way. However, older patients with cancer often have more~     complicated issues to manage. For example, older patients often have other medical problems,~     take more medications, and be dependent on others for help and transportation. Too often, the~     medical team is unaware of these issues which can effect the patients care.~      The purpose of this study is to apply a set of questions designed specifically for patients~     with cancer who are older than 65 years of age. These questions are called a geriatric~     assessment.~      The investigators want to better understand which older patients with ovarian cancer will be~     able to tolerate the chemotherapy and surgery and why. This study will also see if a~     telephone call from a nurse who specializes in caring for older patients will improve patient~     care. This study will determine how feasible it is to perform geriatric assessments and~     telephone calls in patients with ovarian cancer.~   "
160033|NCT01471470|"~     The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and~     bevacizumab are effective in the treatment of unresectable advanced gastric cancer.~   "
160034|NCT01471457|"~     The primary objective of this prospective, randomized, controlled study is to assess the~     effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use~     pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for~     >1 year are recruited in to the study and randomized to using Trimo-San gel daily or not~     using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis~     (OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and effect~     of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post pessary~     fitting. The investigators hypothesize that Trimo-San gel with not significantly affect the~     rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and Gram stain,~     but will have a positive effect on the subjective symptoms experienced by women wearing~     pessaries.~   "
160035|NCT01471444|"~     The goal of this clinical research study is to learn if combining busulfan with clofarabine~     and fludarabine can help control the disease better than the previous standard method (using~     busulfan and fludarabine alone) in patients with AML or MDS. The safety of this combination~     therapy will also be studied.~   "
160036|NCT01471405|"~     This non-interventional retrospective study aims to describe the therapeutic procedures and~     modalities received by patients and the correlation to hormone status, during a one year~     follow up from completion of the 2-79-52030-207 study.~   "
160037|NCT01471392|"~     The overall goal of the present study is to provide evidence of concordant test results using~     the Identigene STD Test Collection Kit for self-collection and transport of specimens to a~     qualified testing laboratory. It is expected that this method will aid in detection of CT and~     NG and that offering a method of self-collection of a male urine or female vaginal swab~     specimen will encourage testing for CT and NG and improve the overall detection of reporting~     of these STDs by allowing persons who suspect they have the infection to be tested in a~     discrete and confidential manner. The reporting of CT and NG are underestimated and many~     subjects will not visit a clinic or obtain treatment if gone undetected. Thus, allowing a~     self-collection kit that is more convenient may result in improved reporting, identification~     of CT and NG positive individuals, and subsequent treatment to help prevent the spread of~     these diseases.~      The purpose of this study is to demonstrate that the Identigene STD Test Collection Kit and~     labeled instructions for use instructions provide test results that are concordant (at least~     95% or better) with test results obtained using the Gen-Probe APTIMA Combo 2 specimen~     collection and transport methods performed under the supervision of a healthcare provider.~     The laboratory technology and test method used for the IDTG-100.~   "
160038|NCT01471327|"~     SB-240563 is a fully humanized monoclonal antibody which is specific for human interleukin-5~     (IL-5) and has been under development for severe refractory asthma. This study is the first~     study in Japanese subjects. The purpose of this study is to evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of single dose SB-240563 administered~     intravenously to Japanese healthy male subjects.~   "
160039|NCT01471314|"~     The purpose of this study is to examine migraineurs during spontaneous migraine attacks~     without aura, using high resolution magnetic resonance imaging (MRI), to study following:~        -  Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using~          functional MRI (fMRI).~        -  Changes in circumferences of intra- and extracranial arteries using MR-angiography~          (MRA).~        -  Changes in regional and global cerebral blood flow (CBF) using the arterial spin~          labeling (ASL) method.~      Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine attacks.~      The migraine specific drug sumatriptan will be given to relieve pain and the effect will be~     registered using MRA and fMRI if possible.~   "
160040|NCT01471301|"~     The purpose of this study is to evaluate ultrasound hands in patients with systemic lupus~     erythematosus.~   "
160041|NCT01471288|"~     Carum Carvi has been frequently used in traditional medicine for a variety of disease ranging~     from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients with~     thyroid cancer who receiving Carum Carvi despite being on suppressive dose of levothyroxin.~     TSH level returned to normal after discontinuation of the Carum carvi. This observation led~     to a pilot study for evaluation of the effect of carum carvi on thyroid function.~   "
160042|NCT01471275|"~     With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi~     decoction in treatment of obesity with type 2 diabetes, dyslipidemia~   "
160043|NCT01471262|"~     As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal~     with an emerging aged population, which has a potential higher risk for complication and~     worse long-term outcome. The investigators will be analyzing the liver function and outcome~     after right or extended right hepatectomy in patients over 70 years old.~   "
160109|NCT01470391|"~     The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus~     the Femoral Nerve Block on muscle strength, pain and mobilization after total knee~     arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain and~     morphine consumption as the Femoral Nerve Block, but without the same reduction in quadriceps~     muscle strength.~   "
160044|NCT01471249|"~     This study consists of a prospective clinical trial which aims to evaluate the impact of~     stent insertion for palliation of malignant dysphagia. The main goal being to examine the~     number of days required following stenting in order to have significant improvement in~     dysphagia and the length of time that this baseline is maintained. Approximately 100 patients~     will be prospectively enrolled in this study.~      Patients with end stage inoperable esophageal cancer deemed candidates for intraluminal~     esophageal palliative stent insertion will be prospectively enrolled into the study. Patients~     with esophageal obstruction or stricture due to other benign causes, tumors obstructing the~     cervical esophagus, as well as patients with airway-esophageal fistulas will be excluded from~     the study.~      The investigators plan to evaluate the efficacy of intra-esophageal stent insertion to~     improve malignant dysphagia as a main factor affecting the quality of life in these patients.~   "
160045|NCT01471236|"~     The purpose of this study is to determine the performance of the Agili-C implants. The study~     hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and~     cartilage-bone joint surface defects.~   "
160046|NCT01471223|"~     The purpose of the study is to estimate the incidence rates of Post-transplant~     Lymphoproliferative Disorder (PTLD), malignancy and hospitalized infections in adult~     kidney-only transplant recipients treated with Belatacept, and compared the incidences to the~     incidences in those treated with Calcineurin inhibitor (CNI) based regimens at the time of~     transplantation.~   "
160047|NCT01471210|"~     The purpose of the study is to assess the safety, tolerability, pharmacokinetics and~     immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or~     metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma~   "
160048|NCT01471197|"~     The purpose of this trial is to determine whether Ipilimumab will prolong survival when~     compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.~   "
160049|NCT01471184|"~     The primary objective of this study is to assess the relative efficacy of Ectoin® Allergy Eye~     Drops and Ectoine® Allergy Nasal Spray compared to placebo, by evaluating Total Nasal Symptom~     Score (TNSS) and Total Ocular Symptom Score (TOSS).~      The secondary objectives are :~        -  To evaluate the relative efficacy of Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal~          Spray compared to placebo by evaluating Total Non Nasal Symptom Score (TNNSS),~          congestion symptom scores, red eye symptom scores, watery eye symptom scores, itchy eye~          symptom scores, and by evaluating the mean cross-sectional area (MCA) using acoustic~          rhinometry (AcR).~        -  To assess the change from baseline (post-EEC from pre-EEC) in inflammatory parameters of~          nasal secretions, comparing Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal Spray to~          placebo at each post-treatment visit.~   "
160050|NCT01471171|"~     The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a~     day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation~     and dyspnoea at rest and during exercise after 3 weeks of treatment.~   "
160051|NCT01471158|"~     The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT®~     after a single drop of each medication is administered to both eyes, in patients with~     open-angled glaucoma or ocular hypertension.~   "
160052|NCT01471145|"~     The aim of this project is to study brain functions of 20 heroin addicts (compared to brain~     functions of 20 healthy controls) just before and during a three month extended release~     naltrexone treatment using functional MRI and dopamine transporter SPECT.~      The following hypotheses are tested:~        -  XRNT modulates the fMRI response to drug cues in predetermined brain regions.~        -  The expression of striatal transporters (assessed with SPECT) will decrease after a~          three-month course of extended release naltrexone~   "
160053|NCT01471132|"~     The recurrence and metastasis of peritoneum is always the lethal consequence for gastric~     cancer patients, and there is no effective therapy until now. It has been reported by~     Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called~     hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer~     cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy,~     HIPEC with combination regimen would have a brighter prospect. In this study, the~     investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and~     overall survival would be observed and evaluated.~   "
160054|NCT01471119|"~     To assess the effect and safety of sublingual Dermatophagoides Farinae Drops in adult~     patients with atopic dermatitis and allergic sensitization to house dust mites.240 adults age~     18 to 60 years with atopic dermatitis(Objective Scoring Atopic Dermatitis, Objective SCORAD~     from 10 to 40) are going to be enrolled in a randomized,double-blind,placebo-controlled~     study.Sublingual Dermatophagoides Farinae Drops or placebo is given for 9 months in addition~     to standard therapy.SCORAD,average anesis interval,rescue medicine and DLQI will be recorded.~   "
160055|NCT01471106|"~     The goal of this clinical research study is to learn if dasatinib can help prevent breast~     cancer from developing in the unaffected breast.~      Dasatinib is designed to decrease the activity of one or more proteins that are responsible~     for the uncontrolled growth of tumor cells.~      This is an investigational study. Dasatinib is FDA approved and commercially available for~     the treatment of leukemia. Its use in breast cancer patients in investigational.~      Up to 66 patients will take part in this multicenter study. Up to 60 will be enrolled at MD~     Anderson.~   "
160056|NCT01471093|"~     The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy~     subjects.~   "
160057|NCT01471080|"~     In the past, the investigators often treated giant cavernous hemangiomas of the liver by~     hepatectomy.Recently RFA and laparoscopic hepatectomy are also available and could be applied~     to cure this disease.But we can't get a clear answer about their effectiveness and safety.~     Hence the investigators conduct this study to explore the effectiveness and efficiency of the~     these two methods and compare their short to mid-term outcomes.~   "
160110|NCT01470378|"~     This study will investigate the subcutaneous tissue changes in the lymphedema found after~     thigh surgery, by circumferential measure of thr thighs and by magnetic resonance imaging~     verifying the effects of postoperative lymphatic drainage.~   "
160146|NCT01469897|"~     This project seeks to collect data on healthcare utilization and expenditure rates in~     Juvenile Idiopathic Arthritis (JIA) patients from across the US, correlate these costs with~     disease activity and outcome measures and determine methods by which to reduce the economic~     impact while improving outcomes.~   "
160058|NCT01471067|"~     The goal of this clinical research study is to learn if it is safe and feasible to transplant~     changed cord blood for patients with leukemia or lymphoma. Researchers also want to learn if~     this can help to control the disease.~      The cord blood will be changed to make use of sugar that is found in small amounts in blood~     cells. It plays a role in signaling where in the body the transplanted cells should go to.~     Adding more sugars to the cord blood cells in the laboratory is designed to help the cord~     blood cells find their way faster to the bone marrow. This may help your blood counts to~     recover faster. This process is called fucosylation.~      Anti-thymocyte globulin (ATG) is a protein that removes immune cells that cause damage to the~     body.~      Clofarabine is designed to interfere with the growth and development of cancer cells.~      Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which~     may cause the cancer cells to die. This chemotherapy is also designed to block your body's~     ability to reject the donor's bone marrow cells.~      Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer cells~     to die.~      Mycophenolate mofetil (MMF) and tacrolimus are designed to block the donor cells from growing~     and spreading in a way that could cause graft versus host disease (GVHD -- a condition in~     which transplanted tissue attacks the recipient's body). This may help to prevent GVHD.~      Rituximab is designed to attach to cancer cells, which may cause them to die.~   "
160059|NCT01471054|"~     To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex) and~     compare it with safety and efficacy of intravitreal bevacizumab in eyes with macular edema~     after plaque radiotherapy of uveal melanoma.~   "
160060|NCT01471041|"~     The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in~     achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as~     prescribed.~   "
160061|NCT01471028|"~     The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect~     to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver~     decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E providing~     additional survival data up to a maximum of 5 years that will be included, as available,~     through VTI-208 study termination (after the last surviving enrolled subject completes Study~     Day 91).~      Secondary objectives are to determine the proportion of survivors at Study Days 28 and 91.~      Exploratory objectives are to evaluate the ability of ELAD to stabilize liver function,~     measured using the Model for End Stage Liver Disease (MELD)-based time to progression (TTP)~     up to Study Day 91, and the proportion of progression-free survivors (PFS) up to Study Days~     28 and 91. Progression is defined as death or the first observed increase of at least 5~     points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at~     least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to~     both End of Study Days 28 and 91 following Randomization.~   "
160062|NCT01471015|"~     Selective head cooling or whole body hypothermia has become the standard of care for neonatal~     hypoxia-ischemia encephalopathy (HIE). Despite early intervention death or major~     neurodevelopmental disability still occurs in nearly 50% of infants ≥ 36 weeks gestational~     age (GA) treated with cooling. No additional therapies have proven to be efficacious in~     further reducing brain injury and impairment for these high risk infants. Neuroprotective~     strategies aimed at improving early childhood outcomes are still needed. An important area of~     study includes therapies that may complement the neuroprotective effects of hypothermia and~     promote neuronal regeneration, recovery and neurovascular remodeling. Among these therapies,~     erythropoiesis stimulating agents (ESA) have been shown to provide neuroprotection, improving~     short and long-term neurologic outcome in brain injury and HIE in neonatal and adult animal~     models. Parallel with neuroprotective effects in experimental settings, recent small clinical~     studies suggest improved outcomes after ESA administration in patients with severe traumatic~     brain injury and HIE. ESA may work through several important mechanisms including reduced~     inflammation, limited oxidative stress, decreased apoptosis and white matter injury, as well~     as via pro-angiogenic and neurogenic properties.~      Darbepoetin alfa (Darbe), a recombinant human erythropoietin (EPO)-derived molecule, has an~     extended circulating half life and comparable biological activity to EPO, including~     activation of the EPO receptor. The proposed study is a Phase I/II dose safety and~     pharmacokinetic trial of early Darbe administered concurrent with hypothermia in human~     newborn infants with moderate to severe birth asphyxia. The long-term objectives of the~     proposed research are to reduce mortality and to decrease the risk of long-term disabilities~     in infants with HIE who survive beyond the newborn period.~   "
160063|NCT01471002|"~     The main objective is to evaluate the oncologic efficacy of percutaneous cryoablation of~     renal tumors smaller than 4 cm in patients with renal cancer that cannot be offered a partial~     nephrectomy. The oncologic outcome will be assessed by the presence or absence of residue or~     recurrence during a follow-up by MRI performed the first 12 months (M1, M3, M6, M12).~   "
160064|NCT01470989|"~     This was an 18-month, multi-center, open-label, clinical extension study. Patients completing~     earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated~     in this combined extension 3 study for any new gouty arthritis flare on demand with one~     subcutaneous (s.c.) injection of canakinumab 150 mg.~   "
160065|NCT01470976|"~     The primary aim of the study is to investigate whether a goal-directed resuscitation therapy~     in high-risk patients through cardiac index optimization using the LiDCO Rapid device reduces~     complications after cardiac surgery. The hypothesis is that there are better outcomes when~     achieving a cardiac index higher than 3L/min/m2 in those patients with an arterial lactate~     higher than 1.5 mmol/L.~   "
160066|NCT01470963|"~     The purpose of this study is to examine whether the implementation of a referral template~     will increase quality of health care delivered and the quality of health care co-operation.~     The investigators intent to implement a referral template, at the level of the general~     practitioner (GP), for the referral of patients within 4 separate diagnostic groups:~        -  dyspepsia/upper GI symptoms~        -  colonic cancer investigation/lower GI symptoms~        -  chronic obstructive pulmonary disease (COPD)~        -  chest pain~      Local GP clinics will be randomised to use the referral template or to use standard referral~     practice. Using a predefined set of quality criteria the investigators will score the process~     of care in each patient, and compare intervention and control groups. In addition other~     criteria will be collected and compared between the two groups, e.g.~        -  time to diagnosis/treatment~        -  quality of referral~        -  more appropriate referrals~        -  patient satisfaction (as measured by a questionnaire)~      The investigators hypothesize that the implementation of a referral template will lead to a~     measurable increase in the quality of health care delivered.~   "
160111|NCT01470365|"~     This phase I trial studies the side effects and best dose of 3-dimensional conformal~     radiation therapy (CRT) or intensity-modulated radiation therapy (IMRT) in treating patients~     with recurrent tumors. Radiation therapy (RT) uses high energy x rays to kill tumor cells.~     Palliative radiation therapy may help patients with recurrent tumors live more comfortably.~   "
160067|NCT01470950|"~     Atrogin-1 and muscle RING finger-1 are skeletal muscle specific genes, with ubiquitin ligase~     activities, that are upregulated during muscle atrophy in mice. The Akt/GSK3 and Akt/mTOR~     pathways are involved in muscle hypertrophy in mice. Recent studies by the investigators team~     and others have demonstrated the implication of these signalling pathways in the control of~     muscle mass in humans. However no study has yet investigated the involvement of these systems~     in the early stages of spinal cord injury induced human skeletal muscle atrophy.~      The investigators propose to investigate the level of expression of the different components~     of the ubiquitin-proteasome system together with the level of expression and activity of the~     Akt/mTOR and Akt/GSK3 signalling pathways after SCI in humans during the first months~     following the injury.~      A second aim of this project is to assess if a novel apparatus of electrical stimulation~     which generate movements by closed-loop electrical muscle stimulation may improve strength~     and muscle mass in these patients.~      The patients will be recruited jointly at the Clinique Romande de Réadaptation (CRR) in Sion~     and the Swiss paraplegic centre in Nottwil. They will be randomly divided into two groups, a~     first group of patients will undergo a conventional treatment of rehabilitation while a~     second set of patients will be treated using a brand new system of electro-stimulation called~     MotionMaker TM. Biopsies will be obtained in the first weeks after admission; two other~     biopsies will be taken respectively 3 and 6 months post-lesion.~      Our results will provide an increased understanding of the molecular mechanisms contributing~     to skeletal muscle atrophy during the early stages following SCI and a characterization of~     the impact of endurance training in the no more voluntary innervated muscle. Moreover this~     study will also investigate the potential improvement in the rehabilitation process by using~     a new system of electro-stimulation.~   "
160068|NCT01470937|"~     This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control~     in early Type 2 diabetes mellitus.~   "
160069|NCT01470924|"~     A minority of patients with adult acute lymphoblastic leukemia (ALL) relapse are rescued. The~     aim of this population-based study was to assess the results of reinduction treatment and~     allogeneic stem cell transplantation (SCT) in second complete remission (CR) in Sweden~     2003-2007.~   "
160070|NCT01470911|"~     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway~     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent~     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of~     the immune system caused by cytokine production. A substantial number of asthma patients do~     not satisfactorily respond to steroid therapy and consequently have an unmet medical need for~     novel targeted therapies with improved specificity, tolerability, and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of asthma. The~     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and~     has been shown to be necessary and sufficient for the production of cytokines interleukin~     (IL)-4, IL-5, and IL-13. The active principle hgd40 of the investigational medicinal product~     SB010 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA~     (deoxyribonucleic acid) zymes (antisense oligonucleotide). DNAzymes are catalytically active~     nucleic acids that cleave complementary RNA (ribonucleic acid) molecules. By cleaving GATA-3~     mRNA hgd40 reduces specific cytokine production and thereby reduces key features of allergic~     airway inflammation.~      DNAzymes are completely generated by chemical synthesis and can be produced under Good~     Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs,~     i.e. they are not generated by use of any living organism including cell culture or bacteria.~     The molecules are highly water-soluble and will be applied as solution directly in their~     synthesized form.~      The current study will evaluate the safety and tolerability of increasing single doses of~     inhaled SB010 in healthy male subjects.~   "
160071|NCT01470898|"~     Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness.~     Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably~     help to shorten recovery time and reduce drug consumption. The aim of the study was to~     investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative~     anesthesia consumption.~   "
160072|NCT01470885|"~     Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a~     systemic inflammatory response syndrome with significant morbidity and mortality in 20% of~     patients. Part of endocrine function of pancreas would be affected in AP. Stress~     hyperglycemia would explode at acute phase. So the investigators decide to follow up and~     observe 200 cases of patients with acute pancreatitis, determining of blood sugar, blood~     amylase, hemoglobin and glycosylated hemoglobin level. At last, using ROC curve method to~     identify the die cutting between blood glucose level and acute pancreatitis, and makes~     analysis of the diagnostic value.~   "
160073|NCT01470859|"~     Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the~     first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous~     clinical trial indicated that initial pramipexole owns advantage over levodopa regarding~     motor complications, on the contrary, less adverse effect like freezing and severe somnolence~     favors initial treatment of levodopa. Thus, it remains controversial that initiation of which~     medication will be better for those patients with early PD.~      Parkinson's disease-related spatial covariance patter (PDRP) is a new biomarker which can~     represent the network activity of brain and severity of PD. Based on the literatures and our~     previous data, the investigators hypothesize that PDRP will be served as a biomarker to help~     us evaluate and compare the effect of levodopa or pramipexole on the progression of PD, which~     might be able to provide further evidence for clinicians to address the above critical issue.~   "
160074|NCT01470846|"~     Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and~     postoperative respiratory complications together with quicker recovery of bowel function.~     Currently, no studies have been able to prove its ability to reduce length of stay in~     intensive care and high-dependency units.~      Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of~     stay in intensive care unit after abdominal surgery under laparotomy.~   "
160075|NCT01470833|"~     Acute achilles tendon rupture is relatively frequent (11 to 37 per 100,000). There are great~     social benefits in optimizing treatment and shortening recovery.~      There is no consensus concerning the best treatment of acute achilles tendon rupture.~     Traditionally, surgical treatment is considered superior, but more recent studies show~     evidence that non-operative treatment with early dynamic rehabilitation gives the same~     functional outcome with fewer side effects.~      Traditionally non-operative treatment involves non-weightbearing for 6 weeks. This is not~     evidence based rather due to tradition. It is well documented that mechanical load improves~     tendon healing in general and has no detrimental effect on the healing of operated achilles~     tendons.~      The objective of this randomized study is to compare early weight-bearing with~     non-weight-bearing following non-operative treatment of acutely ruptured Achilles tendons.~   "
160089|NCT01470651|"~     Fatigue is one of the most common side effects of the treatment of hepatitis C infection with~     pegylated interferon and ribavirin, and is a major cause of treatment discontinuation.~     Armodafinil is an FDA approved stimulant medication for the treatment of narcolepsy and~     shift-work sleep disorder. This is a randomized placebo controlled study to determine whether~     patients assigned to armodafinil have fewer missed doses, dose reductions or treatment~     discontinuation due to side effects in the first 12 weeks of treatment for hepatitis C~     infection than do placebo patients. Placebo patients are offered 14 weeks of open label~     armodafinil after Week 12.~   "
160076|NCT01470820|"~     Background: Using light emitting diodes (LED's) during conventional phototherapy it is~     possible to reduce the distance from light source to infant, thereby increasing light~     irradiance.~      Objective: To examine the relation between light irradiance and the rate of decrease in total~     serum bilirubin concentration (TsB) and to see if the investigators can identify a~     saturation point, i.e. an irradiation level above which there is no further decrease in~     TsB.~      Design: Prospective randomised study. Setting: Neonatal Intensive Care Unit, Pediatric~     Department, Aalborg Hospital, Aarhus University Hospital, Denmark.~      Material and method: 151 infants with gestational age ≥ 33 weeks and uncomplicated~     hyperbilirubinaemia are randomised to one of 4 different distances from phototherapy device~     to mattress (20, 29, 38 and 47 cm). TsB is measured before and after 24 hours of phototherapy~     and irradiance every 8th hour. Main outcome measure is 24 hours decrease of TsB expressed in~     percent (∆ TsB0-24 (%)).~   "
160077|NCT01470807|"~     A single arm, single treatment study is proposed to assess the feasibility of a portable~     artificial pancreas system outside of a hospital based clinical research center.~      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous~     insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions~     (hotel).~   "
160078|NCT01470794|"~     This is a multicenter study evaluating the safety and tolerability of increasing doses of~     Toca 511, a retroviral replicating vector, injected into the resection cavity of patients~     with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their~     tumor. Approximately 6 weeks after injection of Toca 511, patients will begin an oral courses~     of Toca FC, an antifungal agent. These one week courses of Toca FC will be repeated during~     the approximately 30 week study. Two separate cohorts of patients treated with Toca 511 and~     Toca FC will also be evaluated with either of the following standard treatments for glioma:~     lomustine or bevacizumab. After completion of this study, all patients will be eligible for~     enrollment and encouraged to enter a long-term continuation protocol that enables additional~     Toca FC treatment cycles to be given, as well as permits the collection of long-term safety~     and survival data.~   "
160079|NCT01470781|"~     The purpose of the present study is to evaluate a neuroplasticity-oriented, computer-based~     cognitive remediation treatment program in patients with bipolar disorder and its effects on~     cognitive deficits and community functioning compared to an active, computer-based control.~   "
160080|NCT01470768|"~     This clinical trial will compare the amount of fatty acids in whole blood of babies fed one~     of two study formulas for 4 months.~   "
160081|NCT01470755|"~     In older children and adults, bronchodilator (BD) dose-effect relationship is part of the~     characteristics of asthma disease. There are no data on BD dose-response relationship in~     wheezy preschool children whose disease pathophysiology is poorly understood, but may, in~     part, takes on the characteristics of asthma.~      The investigators assume that 1) in young children interrupter resistance (Rint) could be~     used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the~     dose-response relationship could depend on the environment and gene polymorphism ADBR2.~      This is a prospective phase II study on dose-response relationship and description of the~     dose-response curve design using a sparse and a modeling approach MCP-Mod.~      The dose-response relationship will be modeled by sparse data. The investigators will test~     two doses per child in four designs that will be drawn. These doses will be assessed using~     Rint technique by a person blinded to the actual dose delivered to the child.~      Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with~     an accuracy of 3.5%, 8.9% and 25.7% respectively.~      The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for~     inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA~     (No. 344 387-3)~   "
160082|NCT01470742|"~     The objective of the trial is to compare Overall survival between capecitabine plus~     oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with~     advanced gastric cancer.~   "
160083|NCT01470729|"~     Autosomal dominant cerebellar ataxias (ADCA) are a group of neurodegenerative disorders that~     are clinically and genetically various. BIOSCA study aims to identify markers of the~     metabolism (energy production inside the cells) in the blood and the brain of ADCA 1,2,3 and~     7 patients and control subjects, in the perspective of future therapeutic trials.~   "
160084|NCT01470716|"~     This study examines preoperative Erlotinib in patients with operable stage II and IIIA~     Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.~   "
160085|NCT01470703|"~     This international multicenter, randomized, open trial will evaluate the impact of~     Extracorporeal Membrane Oxygenation (ECMO), instituted early after the diagnosis of acute~     respiratory distress syndrome (ARDS) not evolving favorably after 3-6 hours under optimal~     ventilatory management and maximum medical treatment, on the morbidity and mortality~     associated with this disease.~   "
160086|NCT01470690|"~     The objective of this study is to determine the effect of multiple dose omeprazole on the~     pharmacokinetics of boceprevir and vice versa.~      Furthermore, the safety of steady state boceprevir combined with multiple dose omeprazole~     will be evaluated.~   "
160087|NCT01470677|"~     This is a randomized trial of 140 women with endometrial or cervical cancer undergoing~     removal of lymph tissue (lymphadenectomy). The application of 4 tachosil fibrin patches to~     the pelvic side wall after tissue removal is tested against no such intervention after tissue~     removal. The primary endpoint is to evaluate the incidence of symptomatic pelvic lymphoceles~     defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing open or~     laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the~     application of Tachosil® during surgery. The study's hypothesis is that the application of~     tachosil fibrin patches will significantly reduce the rate of symptomatic lymph cysts.~   "
160088|NCT01470664|"~     This randomized, double masked, multi-center study is being conducted to support the safety~     and efficacy of FST-100 for the treatment of acute adenoviral conjunctivitis.~   "
160090|NCT01470638|"~     The study aims to correlate levels of Flt3-ligand in Cerebrospinal Fluid (CSF) and serum to~     markers for inflammation and degeneration in patients with primary Sjogrens syndrome.~   "
160091|NCT01470625|"~     This is a before-after phase II study, according to the Medical Research Council framework,~     investigating the feasibility of introducing the Liverpool Care Pathway for the dying patient~     (LCP) in 5 Ligurian hospices.~   "
160096|NCT01470560|"~     Many women experience the accidental loss of urine called urge incontinence or overactive~     bladder (OAB) incontinence. Women describe this as a sudden, strong desire to pass urine~     which results in leakage before reaching the toilet. The current usual treatments for urge~     incontinence include behavioral treatment, physical therapy, and medicines. Although these~     treatments have been found to be effective in research studies, they are less effective over~     time in general practice. Because medicines have side effects, many women stop them. The~     purpose of this study is to explore different treatments that may provide another option for~     women with urge incontinence that might be effective. This is an initial study to see if~     these treatments are at least as effective as the usual treatments.~      Hypothesis: Does Mind Based Stress Reduction(MBSR)(meditation practices)reduce urinary urge~     incontinence episodes?~   "
160097|NCT01470547|"~     The portal vein thrombosis (PVT) can complicate medical conditions like liver cirrhosis (LC),~     neoplasms, myeloproliferative diseases, thrombophilic genotypes, infections, inflammatory~     diseases, trauma and surgery. LC is an important predisposing disease and is responsible for~     about 20% of all cases. However, data regarding the PVT in cirrhosis are insufficient.~      Early studies have shown that, in absence of hepatocellular carcinoma (HCC), the PVT can~     occur in approximately 10% of cirrhotic patients.~      Most of studies are in support of a prevalence between 5 and 20% of patients with LC. A study~     in transplant recipients, has documented that in variable etiology cirrhosis, the PVT was~     present in 15.7% of patients, a higher percentage was found in patients with liver cancer~     (34.8%), while primary biliary cirrhosis (7.9%) and sclerosing cholangitis (3.6%) are less~     frequently complicated by PVT.~      The PVT development is due to stagnation in the portal circulation, but alterations in the~     sense of inherited or acquired pro-coagulant may favor its appearance.~      The causal association of PVT with bleeding and bowel infarction suggests that the PVT may~     reduce survival in cirrhosis, but data are lacking on this issue. It is also not known~     whether asymptomatic patients with PVT have a different survival compared to cirrhotic~     patients without PVT. Further studies should be conducted to clarify this issue.~      Likewise, prospective studies are needed to better identify risk factors predisposing to PVT~     in LC patients as well as to clarify the relationship between cirrhosis severity and PVT. The~     impact of PVT on the natural history of cirrhosis is an issue today still debated.~      The PVT not only favour life-threatening complications (gastrointestinal bleeding and~     mesenteric thrombosis) but could also contribute to a deterioration of liver function by~     reducing portal flow. Obtaining such information would be of crucial importance considering~     that the evidence of increased mortality related to PVT in liver cirrhosis may indicate the~     need for randomized controlled trials to clarify the potential effectiveness of anticoagulant~     therapy to improve the survival.~      To this purpose it's proposed to establish an Italian register of patients with cirrhosis. In~     the second phase of the project is planned a 2-years follow-up program in order to assess~     whether the PVT be an additional risk factor for mortality or deterioration of the natural~     history in patients with cirrhosis.~   "
160098|NCT01470534|"~     Having an operation places an enormous burden on the body, leading to the development of~     inflammation and so called 'insulin resistance'. Insulin resistance means the body is unable~     to respond to important hormones that control use of energy. Recent studies have shown that~     patients who develop 'higher' insulin resistance and inflammation have more serious~     complications and take longer to recover after surgery. The investigators do not know what~     controls the development of insulin resistance and inflammation after surgery. Similarly, the~     investigators do not know why certain patients develop much more insulin resistance and~     inflammation than others, even though they have the same operation.~      The main purpose of the study is to try to find out which patients are prone to developing~     greater 'amounts' of insulin resistance and inflammation. The investigators also want to find~     out whether the investigators can reduce the 'amount' of insulin resistance and inflammation~     in these patients (for example by giving them carbohydrate [sugar-based] drinks before~     surgery - these have been shown to reduce insulin resistance in some patient groups).~      Information from this study should improve the way the investigators prepare patients before~     surgery and this should help to improve patient outcomes following surgery (by reducing~     complications and speeding recovery after major surgery).~   "
160099|NCT01470521|"~     The purpose of this study is to determine whether people with MS who are exposed to a small~     number of hookworms will have less inflammation and less MS disease activity.~   "
160100|NCT01470508|"~     Promoviendo Alimentacion Saludable (PAS)Promoting Healthy Eating is a research project~     funded by the National Institute of Mental Health. The purpose of this study is to develop~     and test a treatment for eating disorders in Latina adults that is appropriate for their age~     and includes culturally appropriate family intervention.~   "
160101|NCT01470495|"~     RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a~     promising drug to treat late stage HCC. But few studies were related with its effectiveness~     on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might~     reduce the frequency of recurrence and improve the overall survival and disease free survial.~   "
160102|NCT01470482|"~     Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby~     improve fixation, it might also cause complications. Migration as measured by~     RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use~     of a tourniquet influences fixation measured with RSA.~   "
160103|NCT01470469|"~     This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years~     with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and~     ECGs.~   "
160104|NCT01470456|"~     Primary Objective:~      Participants Achieving an Objective Response Rate (Cheson 2007)~      Secondary Objectives:~        -  Progression Free Survival~        -  Overall Survival~        -  Response Duration~   "
160105|NCT01470443|"~     The objective of the trial is to compare Progression free survival between GEMOX~     (gemcitabine/oxaliplatin)vs XELOX(capecitabine/oxaliplatin)in metastatic or unresectable~     Biliary tract carcinoma patients.~   "
160106|NCT01470430|"~     The purpose of this study is to measure systemic levels of vascular endothelial growth factor~     (VEGF) and other proteins (e.g. IGF-1) in the systemic circulation of infants with~     retinopathy of prematurity (ROP) following ocular treatment with either intravitreal~     injections of anti-VEGF agents or retinal laser photocoagulation. The primary aim is to~     determine if serum VEGF levels change after treatment.~   "
160107|NCT01470417|"~     This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable~     and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.~   "
160108|NCT01470404|"~     To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity~     profile.~      To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor~     suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric~     cancer patients treated with adjuvant chemotherapy.~   "
160147|NCT01469884|"~     Compare the viral load of hepatitis c virus in patients converted to certican versus patients~     who are maintained on calcineurin inhibitor.~   "
160112|NCT01470352|"~     To delineate brain mechanisms that subserve EA in the healthy state and to identify~     alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance.~     Individuals with migraine will be examined between episodes in order to assess basal~     alterations in the efficiency of spatial and temporal filtering of noxious information. This~     population provides the unique opportunity to examine such processes without confounds~     arising from ongoing pain.~   "
160113|NCT01470339|"~     -  To delineate brain mechanisms that subserve endogenous analgesic (EA) in the healthy~          state.~        -  To identify alterations in mechanisms supporting EA in chronic pain (migraine) and their~          therapeutic relevance.~   "
160114|NCT01470326|"~     In this survey, to collect the safety and efficacy information of Bazedoxifene in daily~     medical practice will be examined. In addition, the necessity of special Investigation and~     post-marketing clinical studies will be examined, while investigating unexpected adverse drug~     reactions during the survey period and understanding of the status of frequency of adverse~     drug reactions in daily medical practice.~   "
160115|NCT01470313|"~     This study is designed to evaluate the safety and tolerability of multiple intravenously~     administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in~     disease activity will also be evaluated.~   "
160116|NCT01470300|"~     The purpose of this research is to investigate how using different methods to reduce the~     energy density of entrees affects daily energy intake in adults. It is hypothesized that~     reducing the energy density of entrees will decrease energy intake. It is also hypothesized~     that reducing the energy density by incorporating fruit and vegetables will decrease energy~     intake more than reducing the energy density by decreasing fat content or adding plain water.~   "
160117|NCT01470287|"~     This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent~     vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.~   "
160118|NCT01470274|"~     The primary objective is to establish the safety of the CO-rebreathing method for measuring~     total blood and plasma volume in CAD patients. The working hypothesis is that the~     CO-rebreathing method is safe in use with coronary artery disease patients and that it does~     not cause myocardial ischemia or cardiovascular damage.~   "
160119|NCT01470261|"~     The aim of the ADDUCE project is to investigate any adverse effects of methylphenidate (trade~     name ritalin) on growth, neurological system, psychiatric states and cardiovascular system~     over a two year period in children and adults.~   "
160120|NCT01470248|"~     The purpose of this study is to study the effect of an anticancer drug, Arsenic Trioxide, in~     patients with small cell lung cancer who have failed at least one standard chemotherapy~     regimen as well as patients who are unable to tolerate the standard treatment for their~     cancer. The investigators seek to establish the safety of and efficacy of Arsenic Trioxide in~     this patient group. The study will include up to 36 participants with small cell lung cancer.~      The investigators want to find out what effects, good or bad, that the study drug has on your~     cancer. This study will also look at specific biomarkers in your blood and in the tumor~     tissue which may help the investigators to determine if the levels of these biomarkers are~     related to tumor response to treatment.~      Arsenic Trioxide, also known by the brand name, Trisenox, is a chemotherapy drug approved by~     the Food and Drug Administration (FDA) for the treatment of a specific type of blood cancer~     called Acute Promyelocytic Leukemia. It works in part by making cancer cells become more~     mature thereby stopping them from growing in number and more likely to die off.~   "
160121|NCT01470235|"~     The purpose of this project is to examine whether the risk of developing ovarian cancer is~     increased in Danish women with congenital missing teeth as a result of their failure to~     develop (hypodontia). Should this prove to be the case, these women could be offered regular~     clinical controls and prophylactic removal of their ovaries when menopause enters and the~     ovaries are no longer functional (producing hormones).~      If there is a connection between congenital hypodontia and the development of different types~     of cancer, the investigators will perform a genetic screening in families with increased risk~     of cancer and hypodontia for changes in relevant genes, based on the current literature. The~     investigators hereby search for new genes, which in a changed form leads to an increased risk~     of cancer and thereby enables us to perform genetic screening in risk families.~   "
160122|NCT01470222|"~     This study is a randomized controlled pilot of a work site weight control intervention. The~     purpose of the pilot is to obtain preliminary data for future NIH submissions. Four work~     sites were identified through a multistage recruiting process. Work sites were randomized to~     either the intervention group, which will receive the intervention immediately following~     randomization or the control group which will receive a shortened intervention over a 1-month~     period, 6 months after the active intervention sites have completed their program. The~     intervention will consist of a variety of activities conducted over a 6 month period, that~     are overseen by a work site-Tufts oversight group, including the following optional elements:~     For overweight and obese individuals, regular support groups for weight loss and prevention~     of weight regain. For all work site employees irrespective of weight, handouts and posted~     informational resources on healthy eating, monthly lunchtime seminars, and food sampling to~     facilitate healthy eating patterns for prevention of weight gain.~      Basic online assessments on health and nutrition will be carried out at baseline (week 0) and~     24 weeks in all work site employees willing to provide information. More detailed online and~     in-person assessments will be performed throughout the 24-week study period in the weight~     loss support group participants (intervention sites) and individuals intending to enroll in~     the support group (control sites).~   "
160123|NCT01470209|"~     This study will assess the safety of combining two agents (everolimus and BKM120) for the~     treatment of advanced cancer arising from solid organ in patients who are no longer~     benefiting from or unable to withstand standard treatment of these conditions.~   "
160124|NCT01470196|"~     Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within~     the cell, which is responsible for degrading or breaking down a wide variety of proteins.~     Carfilzomib has not been approved by the FDA.~      Rituximab and dexamethasone are often used to treat Waldenstrom's Macroglobulinemia (WM),~     alone or in combination with other drugs. Combinations with rituximab, dexamethasone and~     proteasome inhibitors, like carfilzomib, show high levels of activity in WM patients.~      In this research study, the investigators are testing the safety and efficacy of Carfilzomib~     when used along with Rituximab and Dexamethasone as a possible treatment for Waldenstrom's~     Macroglobulinemia.~   "
160125|NCT01470183|"~     This is an exploratory study. No formal hypothesis will be tested.~      The objectives of this study are to follow Lupus Nephritis patients over a period of 12~     months to:~        -  Establish the baseline biomarker characteristics of patients~        -  Determine the variability of biomarker measures over time~        -  Correlate biomarkers with disease phenotype~   "
160126|NCT01470170|"~     Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in many~     other conscious sedation procedures. Alf and Pro have the characteristic of rapid anesthetic~     onset and quick recovery, synergic sedative effect and unwanted side effects too. However,~     the amount of Alf needed in combination with Pro for induction and the timing of~     administration was no standardized. The investigators designed this study to evaluate the~     optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for~     flexible bronchoscopy sedation, and also to evaluate the influence of variable regimen of Alf~     and Pro on hypoxemia, hypotension, cough severity, and Pro injection related pain.~   "
160127|NCT01470157|"~     Background: Sedation is often needed for young children undergoing minor procedures in the~     emergency department (ED). Oral midazolam is one of the most commonly used regimens for~     children undergoing laceration repair but its sedative efficacy was shown to be suboptimal.~     In a few studies oral ketamine has been used successfully for procedural sedation as well.~     The efficacy of using a combination of oral midazolam and oral ketamine for procedural~     sedation has been studied only for invasive procedures in children with malignancies. No~     randomized controedll studies were performed using this sedative combination in children~     requiring laceration repair. Objectives: To determine the efficacy of adding oral ketamine to~     oral midazolam for procedural sedation in children requiring laceration repair compares to~     oral midazolam plus placebo. Design: A randomized, double blind, placebo-controlled study.~     Setting: Pediatric Emergency Department. Participants: Children 1 to 10 years with laceration~     requiring sedation. Interventions: Eligible patients will be randomly assigned to one of two~     treatment groups: oral midazolam plus oral placebo group and oral midazolam plus oral~     ketamine group. Both groups will be given the same volume of medications. Midazolam will be~     given orally in a dose of 0.5 mg/kg (max.-15 mg) with placebo or 0.5 mg/kg (max.- 15 mg) with~     oral ketamine in a dose of 5 mg/kg. The medical staff will be blinded to the treatment given.~     Patient monitoring will be conducted according to the American Academy of Pediatrics (APP)~     and the Israeli health ministry guidelines for monitoring and management of pediatric~     patients during and after sedation for diagnostic and therapeutic procedures. Main outcome~     measures: Pain score: Visual Analog Score (VAS) - by parent. Data analysis: Descriptive~     statistics will be used to describe the study population. Data will be analyzed using t-~     tests for continuous data and Fisher exact test for categorical data.~      Key words: sedation, children, ketamine, midazolam, emergency department.~   "
160128|NCT01470144|"~     This is an open-label, nonrandomized extension to study AC-066A301. The study will assess~     safety and tolerability of ACT-385781A while providing a means for continuing treatment after~     ending participation in study AC-066A301.~   "
160129|NCT01470131|"~     The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in~     combination with bortezomib and dexamethasone to placebo in combination with bortezomib and~     dexamethasone in the treatment of patients with relapsing multiple myeloma who have received~     one previous therapy.~   "
160130|NCT01470118|"~     This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to~     artificial tears (placebo) in the prevention of ocular itching associated with allergic~     conjunctivitis.~   "
160131|NCT01470105|"~     The goal of this study is to improve how we estimate survival of people with cancer that has~     spread to their bone. There have been previous attempts to estimate survival of people with~     cancer that spread to the bone, but they have not been accurate. This study will try to~     improve the way we estimate survival in people with cancer that has spread to their bone by~     looking to see if a physician assessment and a patient assessment of the health status can be~     blended to give a better estimate of survival than patients or doctors alone.~   "
160132|NCT01470092|"~     Longitudinal epidemiological studies have shown that many women experience significant~     physical and psychological changes as they approach menopause and for a long time following.~     Vasomotor symptoms (such as hot flushes, night sweats), sleep disturbances and changes in~     libido are common, and impact significantly on the quality of life, social and personal~     well-being. However, the major reason that many women seek help from menopause clinics or~     their doctors, is for depression and anxiety symptoms. As such, treatment commonly draws on~     traditional approaches for the management of major depression including the use of~     antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or Selective~     Norepinephrine Reuptake Inhibitors (SNRIs) as the first line response. However, standard~     treatment of menopausal depression using antidepressants has only shown small improvements at~     best and at worst, is associated with severe side effects. Some SSRIs have been shown to be~     less effective in postmenopausal women compared to child bearing age women.~      Newer therapies directly targeting the disrupted hormonal systems (in particular estrogen)~     through the administration of such compounds as tibolone, have shown significant potential to~     treat depression with the added benefit of fewer adverse side effects. With growing evidence~     supporting the use of tibolone as a viable and improved treatment for menopausal depression,~     the investigators propose to investigate the potential of tibolone, a selective Hormone~     Replacement Therapy (HRT), to ameliorate de-novo or first onset depression occurring in the~     menopausal period.~   "
160133|NCT01470066|"~     Although interim 18F-fluoro-2-deoxy-D-glucose-positron emission tomography~     (FDG-PET)/computerized tomography (CT) scan has emerged as a powerful prognostic tool in~     predicting treatment outcome in Hodgkin's lymphoma (HL) and diffuse large B cell lymphoma~     (DLBCL), the positive predictive value (PPV) of interim PET/CT scanning has not been~     determined in patients with peripheral T cell lymphoma (PTCL). The sequential interim PET/CT~     will be prospectively investigated to determine whether it provided additional prognostic~     information and could be a positive predictable value for the treatment of PTCL.~   "
160134|NCT01470053|"~     The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus~     azelastine HCl in patients with perennial allergic rhinitis.~   "
160143|NCT01469936|"~     Fibromyalgia is a medical disorder characterized by chronic widespread pain, and a heightened~     and painful response to pressure. Fibromyalgia symptoms are not restricted to pain, leading~     to the use of the alternative term fibromyalgia syndrome for the condition. Other symptoms~     include functional gastrointestinal pain and discomfort.~      The origin of these symptoms is not yet known, and a few hypotheses have been stated. One of~     the supposed mechanisms that may lead to gastrointestinal hypersensitivity is a chronic,~     low-grade, intestinal inflammation due to an increased intestinal permeability.~      In this study, we hypothesise that the food supplement PERMEAPROTECT (that contains, amongst~     other nutrients, glutamine and curcumin) contributes to reducing the intestinal permeability~     and low-grade inflammation, thus improving gastrointestinal quality of life.~   "
160135|NCT01470040|"~     Anti-aggregation therapy, including treatment with low-dose aspirin (LDA) is an established~     risk factor for intracranial hemorrhage, including chronic subdural hematoma (CSDH); however~     evidence guiding the decision to continue or discontinue LDA in patients who have sustained~     mild head trauma with no sign of injury on CT is lacking. The investigators aim to assess~     whether continued aspirin treatment increases the risk of CSDH in mild head trauma patients~     50 years and older who present with negative head CT. The investigators further aim to use~     the initial findings to refine the study design, with the goal of performing a larger,~     multi-institutional study in the future.~      Over a 12-month period, approximately 100 patients ≥50 years of age on LDA prophylaxis~     presenting to Hadassah's Emergency Department after sustaining mild head injury, will be~     examined by the neurosurgeon on call. Those who have no sign of intracranial hemorrhage at~     clinical or CT examination, and who meet inclusion / exclusion criteria, will be invited to~     participate in a randomized study. Informed consent will be obtained. Patients will be~     remotely randomized for continuation or cessation of LDA treatment. Follow-up CT and clinical~     examination will be performed 3-5 weeks after trauma.~      The two-proportions test will be used to assess whether there is a statistically significant~     difference in the rate of CSDH in patients randomized to cessation of LDA therapy and those~     randomized to continuation of LDA. Relationships between the explanatory the dependent~     variables will be explored with classical parametric and nonparametric statistical methods,~     including multivariate analysis, logistic regression, the two proportions test, and the~     independence test. Several measures of association/correlation between pairs of variables~     will be analyzed as well.~      The investigators hypothesize that continuation of LDA will not be associated with increased~     risk for chronic subdural hematoma, and that cessation of treatment will not be associated~     with a decrease in chronic subdural hematoma. The investigators further hypothesize that~     cessation of LDA for this period will not be associated with increased risk for clinically~     significant cerebrovascular, cardiovascular, thrombotic, of embolic event.~   "
160136|NCT01470027|"~     The overall objective of this developmental/exploratory study is to use noninvasive proton~     magnetic resonance spectroscopy (1H MRS) to assess (a) whether brain levels of the~     antioxidant glutathione (GSH) are decreased in vivo, as has been found in postmortem brain,~     in 30 patients with Parkinson's disease (PD) compared to matched controls; (b) whether GSH~     levels in PD brain increase significantly following 30 days of daily supplementation with~     1800mg or 3600mg of N-acetylcysteine (NAC) compared to placebo and to baseline, and (c)~     whether any such increases in brain GSH would be dose-dependent and be associated with a~     change in the participants' oxidative stress profiles. In addition, a clinical assessment~     battery, including quantitative tests of motor function, will be performed to investigate~     potential associations between the NAC intervention, brain GSH levels, oxidative stress~     markers, and clinical presentation. If successful, this study will represent the first~     objective documentation of whether there is a GSH deficit in living PD brain that dietary NAC~     supplementation can mitigate, thereby providing a compelling justification for investigating~     such neuroprotective strategies in larger controlled clinical trials.~   "
160137|NCT01470014|"~     The diagnostic criteria for isolated left ventricular non-compaction cardiomyopathy (IVNC)~     have been well established for echocardiography and cardiac magnetic resonance, such~     validation is lacking for computed tomography (CT). Such criteria are of great clinical~     relevance as a growing number of patients undergo a cardiac CT scan in daily clinical~     routine.~      The investigators aim to test the diagnostic accuracy of cardiac CT in distinguishing IVNC~     from lesser degrees of trabecular layering seen in potential differential diagnoses such as~     cardiomyopathies and left ventricular hypertrophy or dilation.~      The investigators hypothesize that echocardiographic diagnosed pathological trabeculation can~     be distinguished by determining the ratio of non-compacted to compacted myocardium on cardiac~     CT.~   "
160138|NCT01470001|"~     This is a double-blind, randomized, controlled, parallel design (n=140) study with the~     purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void~     Dribbling.~   "
160139|NCT01469988|"~     Evaluate the efficacy and safety of testosterone supplementation on functional capacity,~     biomarkers, quality of life and clinical outcomes for patients with heart failure.~   "
160140|NCT01469975|"~     Advanced synovial sarcoma represents an unmet medical need. The gene encoding frizzled~     homologue 10 (FZD10), a 7-transmenbrane receptor, member of the Wnt signalling receptor~     family, is overexpressed in SS and is undetectable in normal human tissues except placenta.~      OncoTherapy Science Inc. has developed a chimeric humanized monoclonal antibody (mAb) against~     FZD10, named OTSA101. Non-radiolabeled OTSA101 antibody has only weak antagonistic activity~     on SS cell growth. However, Yttrium 90-radiolabeled OTSA101 (OTSA101-DTPA-90Y) showed~     significant antitumor activity following a single intravenous injection in mouse xenograft~     model.~      This first in man clinical trial (Phase I) in relapsing SS patients resistant to Doxorubicin~     and ifosfamide will be divided in 2 parts.~      In Part 1 (imaging part using OTSA101 radiolabelled with Indium 111 [111In]), the~     biodistribution and tumor uptake of OTSA101-DTPA-111In will be followed using 111In as~     radiotracer.~      In Part 2 (therapeutic part with OTSA101 radiolabelled with Yttrium 90 [90Y]), the safety and~     PK profiles of OTSA101-DTPA-90Y will be determined and preliminary efficacy data will be~     collected.~      This first in Man study should allow defining the optimal recommended dose of~     OTSA101-DTPA-90Y.~      Patients will be followed during 1 year.~   "
160141|NCT01469962|"~     Obesity is a frequent disease with an increased prevalence, estimated to 12.4% in France~     (OBEPI study 2006). Non alcoholic fatty liver disease (NAFLD) and non alcoholic~     steatohepatitis (NASH) both complicate morbid obesity and could be responsible for the~     development of liver fibrosis and consequently of liver cirrhosis. Bariatric surgery has been~     widely used in obese patients to reduce their weight but also to decrease morbidity~     conditions related to obesity. It could be involved in an improvement in liver lesions~     observed in obese patients. To evaluate the severity of liver lesions, the gold standard is~     pathological examination of the liver using percutaneous or surgical biopsies, with a scoring~     called Fibrosis score stage. Alternative less invasive techniques have been developed to~     evaluate liver lesions. These tests are commonly used in clinical hepatology and consisted of~     serum levels determination of fibrosis markers (Fibrotest, Transthyretin).~      The aim of this study is to evaluate the evolution of fibrosis scores during weight loss in a~     population of patients operated on for morbid obesity ( BMI > 40kg/m2 or BMI> 35kg/m2 with~     comorbidity). The primary end point is to evaluate the concordance between Fibrotest and~     transthyretin serum levels. The number of patients has been calculated on the basis of a~     concordance ( Kendall test) superior to 70% in patients with grade F1 fibrosis that~     represents about 40% of morbid obese patients. A total of 255 patients has to be enrolled in~     this study. According to the number of patients operated on in the 3 centres (>150/year), the~     time for recruitment is 12 months. Secondary end points will evaluate in these patients the~     excess weight loss, the improvement in fibrosis liver tests and the correlation with~     improvement in other obesity- related conditions, according to surgical procedures.~   "
160142|NCT01469949|"~     Mental imagery has been used in a variety of pathological instances in support to classical~     therapeutic treatments. The aim of the present study was to observe the effect of internal~     Kinesthetic and external Visual Imagery to improve proprioceptive feedback in low back pain.~     Fifty-five subjects with a history of low back pain were included in two experimental groups~     who used mental imagery and one control group who did not. The results showed the~     effectiveness of the Internal Kinesthetic Imagery to improve the accuracy of repositioning of~     lumbo-sacral spine that may subsequently improve the quality of the proprioceptive input. The~     possibility to use effectively mental imagery, as a part of proprioceptive rehabilitation~     process, is the principal outcome of this study.~   "
160149|NCT01469858|"~     The main objective of the study is to explore and map brain areas involved in sensory~     perception and multisensory integration in patients with central or peripheral neurological~     damage. The investigators hypothesize for example, that a change (compare to healthy~     subjects) in the perceptual maps and body representation could be detected and characterize~     in patients suffering from impairments of peripheral nerve conduction.~   "
160150|NCT01469845|"~     Acute bronchiolitis is a common, distressing illness affecting children. A virus infects the~     lungs, and then the airways become blocked, leading to difficulties with breathing. It is the~     most common reason why children are admitted to hospital, with 1-3% of all children admitted~     to hospital during their first winter, creating enormous strains on NHS services. The~     majority of those admitted with the condition are under six months of age and the associated~     stress for parents is considerable. After forty years of research the best treatment we have~     is supportive care and oxygen.~      Recent research suggests that salt water, sprayed as a mist so that the children can breathe~     it in ('nebulised 3% hypertonic saline') might help children with acute bronchiolitis.~     Scientists think that the salt water changes the mucus which blocks the airways so that it~     can be cleared more easily. Three small research studies all suggested that a child's time in~     hospital could be reduced by a quarter by using this treatment. If this was true, it would be~     good for children, their families and the children's wards trying to cope with the large~     numbers admitted with bronchiolitis every year.~      To decide whether this treatment should be used throughout the NHS, we need to run a~     randomised controlled trial of hypertonic saline in a large number of children. The trial~     will tell us if adding saline to usual care reduces distress in both children and parents, as~     well as whether it reduces the length of time they stay in hospital. We will then know if the~     treatment is the best thing for children with bronchiolitis and whether it provides the NHS~     with good value for money.~   "
160151|NCT01469832|"~     The purpose of this study is:~      To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD .~      To evaluate potential efficacy endpoints to be used in future studies RPE cellular therapy.~   "
160152|NCT01469819|"~     The purpose of this study is to determine if lubiprostone may change the rate of movement of~     food and activities in the stomach and intestines in subjects whose gastrointestinal (GI)~     tract is slower due to constipation.~      To be able to measure the time difference in the duration of transit of the FDA approved~     SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to~     lubiprostone.~      The investigators anticipate to capture the possibility to reduce/eliminate the small~     intestinal bacterial overgrowth in chronically constipated patients after administration of~     study drug- lubiprostone.~   "
160153|NCT01469806|"~     The primary objective of the Registry is to allow for tracking of FDA approved and/or cleared~     knees used in primary, revision, unicompartmental or partial total knee arthroplasty (TKA).~     Second, it is our desire to assist orthopaedic surgeons in obtaining and evaluating~     radiographic and functional outcomes data on their PFJ patients using current published~     guidelines. Third, within this Registry, subsets of data on newer technology are being~     collected for the purpose of future publications. The Patello-Femoral Joint Post Market~     Clinical (PFJ PMCF) study is one such subset.~   "
160154|NCT01469793|"~     This multicenter, open-label, dose-escalating study will assess the safety, tolerability, and~     pharmacokinetics of DMOT4039A in participants with unresectable pancreatic or~     platinum-resistant ovarian cancer. Cohorts of participants will receive multiple ascending~     intravenous doses of DMOT4039A.~   "
160155|NCT01469780|"~     The focus of this secondary data analysis is to determine whether pain due to a combination~     of both cardiac and non cardiac sources operates as a mediator of behavior change, an area~     that has not been previously evaluated.~   "
160156|NCT01469767|"~     The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide~     cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).~   "
160157|NCT01469754|"~     Posttraumatic Stress Disorder (PTSD) is a well-documented phenomenon that occurs in cancer~     survivors. PTSD is known to cause problems with anxiety, depression, and quality of life.~     Furthermore, there is little treatment available for cancer survivors who suffer from PTSD.~      Posttraumatic Growth, however, is a lesser known phenomenon that also occurs in cancer~     survivors. It is a positive psychological phenomenon that occurs in some people who have~     suffered a traumatic event--the people who are able to note a greater appreciation for~     life, a stronger relationship with their family/friends, or a new found level of~     spirituality are examples of instances of posttraumatic growth.~      Coping with Lymphoma to Enhance Adjustment and Reduce Stress in Survivors (CLEAR Stress) is a~     study designed to compare the development of PTSD versus the development of Posttraumatic~     Growth in lymphoma patients at any stage of the cancer experience, regardless of treatment.~     The hypothesis is that posttraumatic growth, if it is significant, can reduce the impact of~     PTSD symptoms in the survivor.~   "
160158|NCT01469741|"~     Cognitive impairment is common among non-demented individuals with Parkinson disease (PD) and~     is a significant source of disability and reduced quality of life. Unfortunately, there are~     no successful interventions to address these impairments. Prospective memory impairment is a~     particularly functionally- and clinically-relevant problem in PD. The investigator's project~     will determine if a targeted intervention strategy improves PD participants' prospective~     memory. The investigator's goal is to improve PD patients' everyday prospective memory so~     they can successfully perform desired activities and roles.~   "
160174|NCT01469533|"~     The purpose of this study is to investigate if the application of spinal mechanical~     manipulation on low back region resulted in changes in pressure pain thresholds (PPT) in~     asymptomatic subjects and the extent of the hypoalgesia; whether it is local, regional or~     systemic. Simultaneously, the investigators are to further explore the phenomenon of reduced~     sEMG activity after spinal mechanical manipulation to better understand the immediate effects~     of mechanical manipulation on low back region.~   "
160175|NCT01469520|"~     The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric~     formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in~     comparison to an innovator product. Establishing the bioequivalence of a newly developed~     age-appropriate fixed dose combination of lamivudine/zidovudine/ nevirapine as an oral~     dispersible tablet or a reconstitutable suspension for children is invaluable for future~     product registration and availability of the products to children, thus filling the void in~     pediatric HIV/AIDS therapy.~   "
160159|NCT01469728|"~     Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients~     with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence.~      General anesthesia and one lung ventilation is the standard type of anesthesia employed for~     VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously ventilating~     patients is being increasingly employed to perform several cardio-thoracic surgery procedures~     in an attempt of minimize operative risks and facilitate resumption of daily-life activity.~      The investigators have reasoned that for a simple and palliative procedure such as talc~     pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might~     be considered a potential cause of morbidity and delayed recovery. The investigators have~     also hypothesized TEA could be considered an optimal type of anesthesia in this setting~     leading to a fast recovery a reduced overall workload in medical care.~      In this single-center randomized study, the investigators have comparatively assessed the~     impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive~     results of VATS talc pleurodesis.~   "
160160|NCT01469715|"~     The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies~     Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1~     diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (>180mg/dL)~     glucose levels over a 24 hour period. This will be achieved by monitoring blood sugar levels~     when a regular dinner meal is given, when a liquid breakfast meal (BOOST Original containing~     41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given, when subcutaneous~     insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a regular lunch meal~     is given. A Continuous Glucose Monitor (CGM) is an electronic device that measures and~     displays blood sugar (glucose) levels in the body throughout the day and night. The method~     being used to detect blood sugar in the investigational Glucose Binding Protein-Based~     Continuous Glucose Monitor (GBP CGM) is different than the method that is currently in use by~     commercially available models.~      Some sensors cannot tell the difference between glucose (sugar) and other substances such as~     Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give~     false readings. The GBP CGM is made to only recognize glucose in the body rather than other~     substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators expect~     the new GBP CGM to be more accurate at detecting low blood sugar levels than the current~     devices.~   "
160161|NCT01469702|"~     Bartonella henselae is the etiologic agent of cat scratch disease (CSD). 90% of patients~     present with regional lymphadenitis (typical CSD) while 10% will have disease involving other~     organs, such as neuroretinitis, arthropathy, erythema nodosum, and encephalitis (atypical~     CSD). In most CSD cases resolution occurs in 2 to 3 months although a prolonged course often~     occurs. Data on the efficacy of antibiotic therapy in CSD is limited. Azithromycin has been~     shown to have a small favorable effect in a small comparative study and is commonly~     prescribed for CSD, however its overall effect is not satisfactory. Corticosteroids may be~     effective in the treatment of CSD for the following reasons:~        -  Many experts believe that host response is involved in the pathogenesis of CSD and is~          responsible for the clinical manifestations rather than the direct effect of B.~          henselae. The absence of viable organisms in affected lymph nodes (in the presence of~          positive PCR for B. henselae DNA), and the fact that arthritis, arthralgia and erythema~          nodosum (that are often associated with autoimmune diseases) have been described in CSD,~          support this concept.~        -  Corticosteroids have been anecdotally reported to have been administered to patients~          with CSD, apparently with some success. The purpose of this study is to evaluate the~          efficacy of corticosteroids in addition to azithromycin in CSD. The study hypothesis is~          that corticosteroids will improve out come. Ten patients with typical CSD will be~          treated with a 5-day oral course of prednisone (1 mg/kg up to 60 mg/day) and~          azithromycin (500 mg on day 1 and 250 mg on days 2-5). Patients will be under followed~          up for 3 months. Major outcome measures will include duration of symptoms and signs,~          with particular emphasis on affected lymph node size and duration using a specific~          scoring system (lymphadenitis score, LS). LS will be used to evaluate lymphadenitis at~          each follow-up visit. The time period from baseline LS until 75% and 90% reduction in LS~          in the treatment group will be compared with historical controls. The historical control~          group will be consisted of age, sex, and clinical manifestations-matched CSD patients~          who were treated with azithromycin without corticosteroids.~   "
160162|NCT01469689|"~     Web based cognitive behavioural therapy (webCBT) for depression is recommended by NICE but~     analysis of the geographic distribution of one webCBT site showed 15-fold variation in use~     across Britain. Such variation is unlikely to be from differences in prevalence. Raising~     awareness of webCBT could benefit many people with depression but it is not clear how~     direct-to-patient promotion online or via the media, compares with GP centred methods. This~     pilot cluster randomised controlled trial will explore the use of online methods to raise~     awareness in preparation for subsequent study comparing different approaches.~      In a pilot cluster randomised trial the investigators will explore the feasibility and likely~     impact of online methods of raising awareness of webCBT, assessing how many people with~     depression respond to geographically restricted Google and local website advertisements. The~     investigators will explore costs of recruitment and define and document the best online~     methods that might subsequently be used in a definitive trial comparing online with mass~     media and GP centred methods for raising awareness. The investigators will compare~     intervention with control areas to estimate impact on registration levels and compare rate of~     completion of webCBT of these 'additional' registrants with other registrants.~     Recommendations will be made for a subsequent trial comparing online with other methods.~   "
160163|NCT01469676|"~     To test the hypothesis that leukocyte filtering during cardiopulmonary bypass (CPB) might~     reduce the inflammatory response and protect the lungs against the acute injury~   "
160173|NCT01469546|"~     The purpose of this study is to investigate a new agent Axitinib in the treatment of head and~     neck cancer.~      This is a new drug that is given as a pill twice a day to treat cancer. This is one of the~     new, smart drugs. It binds to a protein on the surface of the cancer cell called VEGFR, and~     this way it slows down the growth of cancer cells and kills them. Head and neck cancer cells~     are known to carry this protein on their surface. Research in animals and in patients with~     other kinds of cancer showed that Axitinib can be effective at killing cancer cells, or~     stopping their growth, by this mechanism. It is generally a safe drug that is given by mouth.~     The investigators do not know, however, whether Axitinib is effective in head and neck~     cancer. This research study is being conducted to learn if Axitinib works in head and neck~     cancer, and also to learn to predict who would benefit from it. Four blood draws will be done~     to check special blood tests while the subjects are treated with Axitinib. These will be~     drawn at the same time as your routine labs, and there will not be additional sticks needed.~     A biopsy of the tumor before and after 1 month of treatment may be obtained to test how the~     cancer cells are responding to treatment. By testing these blood and tissue samples, the~     researchers will look at special tests (protein molecules) to try to determine what kind of~     head and neck patients would best respond to this drug. This is an open-label study, meaning~     that all subjects are on the active drug and there is no placebo (sugar pill).~   "
160164|NCT01469663|"~     This study examines whether depression in people with borderline personality disorder is~     different than depression in people without borderline personality disorder.~      Unlike people who have depression alone (i.e. without borderline personality disorder),~     people with borderline personality disorder have depressions that often do not improve with~     medications. This makes treating depression much more challenging in someone with borderline~     personality disorder than without borderline personality disorder.~      Borderline personality disorderis associated with difficulty in understanding and~     communicating feelings. Impaired emotion processing may reflect dysfunction of an area of the~     brain, the anterior cingulate.~      Depression is associated with changes in anterior cingulate activity. The investigators~     believe that when borderline personality disorder is present with depression, brain activity~     changes in the anterior cingulate will not be the same as in depressed patients without~     borderline personality disorder.~      An electroencephalogram records brain electrical activity. In this study, the investigators~     will measure electroencephalogram indices reflecting anterior cingulate activity.~      HYPOTHESIS: In this study, the investigators predict that when borderline personality is~     present with depression, electroencephalogram indices of anterior cingulate activity will be~     different from when depression is present alone (without borderline personality). This could~     help to explain why people with borderline personality have depressions that are harder to~     treat than depressions in people without borderline personality.~      The investigators also predict that electroencephalogram indices of the anterior cingulate~     will reflect emotional processing ability, as measured by validated questionnaires.~   "
160165|NCT01469650|"~     The specific aims of this study are to determine levels of vitamin D supplementation to~     achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required to~     achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the~     Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized, controlled~     trial, infants 23 weeks gestational age or greater will be randomized to two different levels~     of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day. As an~     exploratory aim, vitamin D binding protein levels (VDBP) will also be quantified in these~     infants.~   "
160166|NCT01469637|"~     This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole~     administered alone & in combination with MMX Mesalazine/mesalamine.~   "
160167|NCT01469624|"~     Contrast induced nephropathy (CIN) is of great concern when using contrast media in the new~     era of medicine. CIN is defined as 25-50% relative increase, 0.5-1 absolute increase in serum~     creatinin value or 25% fall in GFR. The incidence of CIN is found to be 0% to 10% in general~     population and up to 50% in high risk population. High risk patients include those with~     chronic kidney disease (GFR<60 ml/min/1.73 m²) Diabetes Mellitus, congestive heart failure,~     anemia and advanced age. Amount and kind of contrast medium and decreased circulating blood~     volume are other important predictors of CIN. 50% of cases of CIN happen within 24 hours of~     contrast injection. Maximum creatinin levels are reached between 48-72 hours. It usually~     returns to previous levels in 7-10 days. Suggested mechanisms are renal vasoconstriction and~     tubular injury. N-acetylcysteine and hydration are proved to be protective against CIN and~     theophylline may have a role. In this study, it is hypothesized that pentoxifylline, a~     dimethylxanthine, can also protect renal cells from CIN. It has been observed that~     pentoxifylline improves oxygen delivery to ischemic tissues, diminishes oxidative damage to~     renal tissue and may also scavenge free radicals. Percutaneous coronary intervention is~     assumed a high risk procedure for developing CIN as the amount of contrast used in PCI is~     remarkable. Therefore, the patients undergoing PCI were selected for the trial. A prospective~     randomized trial will be conducted on patients undergoing PCI.~   "
160168|NCT01469611|"~     The purpose of this study is to:~        -  determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of~          JX-594 administered by biweekly intravenous (IV) infusion.~        -  determine the safety of JX-594(TK- GM-CSF+ Wyeth strain vaccinia) administered by~          biweekly IV infusion.~   "
160169|NCT01469598|"~     Gemcitabine is a novel analog of the nucleoside deoxycytidine that acts via inhibition of DNA~     synthesis.Docetaxel is a semisynthetic taxane and promotes microtubule assembly and inhibits~     microtubule depolymerization.~      In this study, patients received gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100~     mg/m2 on day 8 with G-CSF support every 3 week.~   "
160170|NCT01469585|"~     The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose~     doxycycline on the irregular bleeding women experience when taking continuous oral~     contraceptive pills. This research is being done because currently, there is no effective~     treatment for this condition. Findings from this study could help to decrease the side~     effects of birth control pills and decrease unplanned pregnancies.~   "
160171|NCT01469572|"~     The purpose of this study is to see the safety and activity of using pasireotide, everolimus~     and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of~     neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or~     radioembolization are considered standard of care regimens in patients with liver lesions~     from neuroendocrine tumors. However, the use of the combination of everolimus and~     radioembolization has not been formally evaluated in the setting of a clinical trial.~     Pasireotide is a medication that is intended to block the hormonal secretions from the~     neuroendocrine tumors.~      This study is divided into two parts. In the first part, the aim of the study is to determine~     the safety of combining everolimus, pasireotide, and radioembolization. For this part of the~     study the investigators will enroll up to 18 patients. After the investigators confirm the~     safety of the combination, they will conduct the second part of the study which will focus on~     evaluating the effectiveness of the combination. For this part of the study the investigators~     intend to enroll a total of 37 patients.~   "
160172|NCT01469559|"~     The aim of this study is to evaluate the safety and tolerability of intranasal insulin in~     people with type 1 diabetes and diabetic peripheral neuropathy and to determine whether~     intranasal insulin is effective in slowing the progression of diabetic neuropathy.~   "
160188|NCT01469338|"~     This phase II trial studies how well octreotide works in reducing diarrhea in patients~     receiving cabazitaxel and prednisone for hormone-resistant prostate cancer (HRPC) previously~     treated with docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several~     hormones in patients receiving chemotherapy for prostate cancer~   "
160176|NCT01469507|"~     The primary objective of this study is to compare a combination of hyaluronic acid and~     chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee~     osteoarthritis (OA) over 24 weeks when administered in three weekly injections.~      Chondroitin sulfate is one of the components of cartilage. Studies have shown that~     chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The~     benefit of V0220 combination is based on two main physicochemical properties, in line with~     the characteristics of osteoarthritic disease: optimising the rheological behaviour and~     improving the buffering effect on synovial flow (outflow buffering).~   "
160177|NCT01469494|"~     The Deep Inferior Epigastric Perforator flap (DIEP) is the current standard of care in breast~     reconstruction. The newer Superficial Inferior Epigastric Artery flap (SIEA) is felt to be an~     improvement as it does not damage the abdominal wall. The SIEA unfortunately has smaller~     vessels which put the flap at a higher risk of developing flap loss and fat necrosis. The~     uncertainty regarding the tradeoffs inherent in the choice of procedure has not been~     resolved. As such the investigators aim to perform a randomized single blinded trial to~     evaluate the abdominal and breast related morbidity associated with DIEP and SIEA flaps.~   "
160178|NCT01469481|"~     The purpose of this study is to evaluate the excretion balance, metabolic profile and the~     routes of excretion of [14C]PF-04991532 in healthy adult male subjects.~   "
160179|NCT01469468|"~     The study is designed to investigate the effect of repeated dosing of PF-05175157 on the~     pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.~   "
160180|NCT01469455|"~     Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed~     cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data~     package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the~     initiation of a phase I clinical study in this population. The recommended starting dose of~     DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting~     Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at~     16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This~     starting dose will be increased up to 96 mg if no DLT occurred during dose escalation.~      DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections~     in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg~     oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a~     week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose~     escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design.~      The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01~     in association with palliative radiotherapy and to evaluate pharmacodynamics and the~     anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration~     of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after~     the beginning of the DT01 treatment.~   "
160181|NCT01469442|"~     Aim : Effect of external biliary duct stent after hepatectomy on the occurence of~     postoperative biliary fistula.~      Methods : French prospective multicenter randomized trial. Population study: Adult patients~     who underwent hepatectomy (> 2 segments) on non-cirrhotic liver.~      Hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a~     external biliary duct stent. With this hypothesis, the number of patients required to be~     equal to 152 per group for a total of 304 patients.~      Outcome measure: Primary : Postoperative biliary complications (biliary fistula, biloma,~     biliary peritonitis) Secondary : All morbidity, mortality, additional manoeuvres to treat~     biliary fistula, during of hospital stay and biliary fistula.~      Follow up: A follow-up of patients 3 months after surgery for all patients. The planned total~     duration of the study is 3 years and 3 months.~   "
160182|NCT01469429|"~     This randomized phase I/II trial studies the side effects and best way to give lyophilized~     black raspberries in preventing oral cancer in high-risk patients previously diagnosed with~     stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to~     keep cancer from forming. The use of lyophilized black raspberries may prevent oral cancer.~     Studying samples of oral cavity scrapings, blood, urine, and saliva in the laboratory from~     patients receiving lyophilized black raspberries may help doctors learn more about changes~     that occur in DNA and the effect of lyophilized back raspberries on biomarkers.~   "
160183|NCT01469416|"~     The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of~     rosuvastatin clinically.~   "
160184|NCT01469403|"~     The purpose of this study is to compare the efficacy in a group of patients who must follow~     the current procedure for treatment of artificial knee, compared with a group of patients who~     must undergo an 8-week weight loss program before surgery. 1 year after surgery the~     investigators will examine whether there are differences between the two groups' quality of~     life and functional capacity.~   "
160185|NCT01469377|"~     An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to~     antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an~     inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo~     + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study~     consisted of approximately 2 weeks of screening and washout followed by 8 weeks of~     double-blind treatment followed by a 1 week safety follow-up.~   "
160186|NCT01469364|"~     This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI~     can be safely and self-administered in lung transplant recipients with newly diagnosed~     bronchiolitis obliterans syndrome, grade 1 (BOS) and obtain pilot data regarding its effect~     on lung function in order to appropriately design and power a larger multicenter randomized~     study.~      The hypothesis is that AZLI is a safe and effective treatment for declining lung function in~     lung transplant recipients with early stage BOS.~   "
160187|NCT01469351|"~     Today Alzheimers disease can not be cured. Animal experiments have shown that the hormone~     GLP-1 can improve memory in Alzheimer-prone mice.~      The investigators hypothesis is that a 6-month treatment with the GLP-1 receptor stimulating~     drug liraglutide will reduce the intracerebral amyloid deposition in the central nervous~     system (CNS) in patients with Alzheimer's disease (AD) and thereby reduce the clinical~     symptoms of the disease.~   "
163519|NCT01425463|"~     To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate~     Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron~     Deficiency Anemia.~   "
160189|NCT01469325|"~     Sequential left prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS), with high~     frequency, for Treatment-Resistant Depression have been shown to have antidepressant effects.~     but doubts remain about the magnitude of previously demonstrated treatment effects.The aim of~     this study is To test whether daily weekday left prefrontal rTMS safely and effectively~     treats Resistant Depression disorder compared to sham controls.~   "
160190|NCT01469312|"~     The objective of this study is to determine whether ingestion of modified pasta products~     (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when~     compared with a traditional pasta.~   "
160191|NCT01469299|"~     The primary objectives of this evaluation are: 1) To attempt to refine the current clinical~     understanding of balance 2) To determine if patients with quantifiably balanced knee joints~     exhibit improved clinical outcomes versus patient with residual imbalance, as measured by the~     VERASENSE™ Knee System~      Secondary objectives:~        -  Determine whether a difference in inter-compartment loads and soft tissue tension exists~          between the physicians intra-operative feel compared to the quantifiable data measured~          by the VERASENSE™ Knee System~        -  Determine which ligament releases are performed by the surgeon to improve soft tissue~          balance while utilizing the information from the VERASENSE™ Knee System~        -  Evaluate range of motion, pain, physical function, activity level, and patient~          satisfaction between baseline (pre-operative) and post-operative follow-up as well as~          radiographic success and survivorship of the knee implants~   "
160192|NCT01469286|"~     Gastroparesis is a common disease defined as delayed emptying of the stomach. It is present~     in at least 20% of about 150 million patients with diabetes worldwide and in more than 20% of~     patients with functional dyspepsia that affects about 10%-25% of the general population.~     Gastroparesis is a refractory disease with a lack of therapeutic options. Common symptoms of~     gastroparesis include nausea, vomiting, early satiety and abdominal bloating.~      Electroacupuncture (EA) is a combined procedure with acupuncture and electrical current~     stimulation instead of manual manipulations of the needles. Recent studies in our lab with EA~     or transcutaneous EA (TEA) have suggested a therapeutic role of EA or TEA for gastric~     motility disorders. Improvement has been observed with EA or TEA in gastric emptying as well~     as dyspeptic symptoms. In this project, a micro-stimulator is designed and developed for the~     TEA therapy. The micro-stimulator is small enough so that it can be attached to the skin next~     to the stimulation electrodes and therefore the patient can resume normal daily activity~     while being treated by TEA. This is not only attractive but also more effective since TEA can~     be performed more often and for longer durations.~      This exploratory project is designed to study the feasibility, efficacy and certain~     mechanisms of the proposed method of wireless TEA in patients with gastroparesis. Firstly~     the feasibility of the chronic use the proposed micro-stimulator will be studied. Secondly,~     the efficacy of the TEA in improving delayed gastric emptying and symptoms of gastroparesis~     will be investigated in a double-blinded crossover design in patients with diabetic or~     idiopathic gastroparesis. Thirdly, possible mechanisms involving pathogeneses of~     gastroparesis with TEA will be investigated.~   "
160193|NCT01469273|"~     This interventional trial shall investigate the efficacy and tolerance of a suspension with~     non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal~     infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. coli~     bacteria of the non-pathogenic Nissle 1917 strain at a concentration of 10exp8 cells per ml.~   "
160194|NCT01469260|"~     The purpose of this study is to evaluate pedometer use by overweight women during pregnancy.~     The study will show if a pedometer will help women to limit weight gain during pregnancy. It~     will also show if it there are other benefits such as decreased diabetes, decreased high~     blood pressure, decreased rates of cesarean section, and decreased complications for the~     baby.~   "
160195|NCT01469247|"~     The goal of this clinical research study is to find a safe dose of radiation that can be~     given to patients with brainstem glioma who have already received radiation therapy.~      You will receive photon radiation therapy. This type of radiation is similar to the radiation~     you have already had. Conformal radiotherapy or intensity modulated radiotherapy (IMRT) will~     be used to try to treat the tumor while affecting as little of the surrounding normal tissue~     as possible.~   "
160196|NCT01469234|"~     The purpose of this study is to determine the onset of action of two commercially available~     over-the-counter antihistamines (Loratadine and~      Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo~     sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research~     Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom~     Complex (MSC) score will then receive drug.~   "
160197|NCT01469221|"~     This is an international, multicenter, double-blind, placebo-controlled, randomized study.~     All eligible patients entering the open label phase of the study will receive a single~     immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral~     resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double~     Blind Phase qualification, patients with confirmed eligibility will be randomized to receive~     either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo~     cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic~     evidence of recurrent disease during the study will be treated according to current treatment~     guidelines or local standard of care. Safety and efficacy assessments will be performed at 3~     month intervals for all randomized patients throughout the study. Patients who receive single~     dose of apaziquone immediately following TURBT and are not eligible for randomization will be~     followed for 3 months by cystoscopic exam and safety assessments.~   "
160212|NCT01469026|"~     The purpose is to elucidate the value of PET/CT applied early in the work-up of patients with~     a metastasising cancer of an unknown primary tumor.~      The management of patients with metastasising cancer of unknown primary often includes~     various and a large number of radiographic studies and invasive procedures, but the occult~     primary tumor is detected in less than 20%.~      Early PET/CT may be useful in Cancer of Unknown Primary (CUP) before expensive and invasive~     diagnostic procedures are carried out. The outcome may be higher tumor detection rate and~     quicker diagnosis, avoiding unnecessary, extensive procedures. Furthermore, a large number of~     the patients will receive treatment aimed at the correct diagnosis. Therefore, a prospective~     cost-effectiveness analysis is warranted.~   "
160198|NCT01469208|"~     The investigators hope to determine if music therapy will have beneficial effects on~     physiologic parameters, behavioral states, and pain scale evaluations in infants with~     gastroschisis defects and if music therapy promotes parental/caregiver relaxation and~     demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their~     infant at risk for chronic gastrointestinal discomfort.~      Babies will be enrolled during the perinatal period, with therapy to begin after surgical~     repair of the gastroschisis defect and when the neonatologist deems the baby stable enough~     for music therapy intervention. Enrolled subjects may receive up to 3 music therapy~     sessions/week and these sessions may continue until discharge. There is no follow up after~     discharge.~      Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:~        1. Pre music therapy behavior state will be assessed using CRIES scale and recorded.~        2. Five minutes of baseline vital signs will be recorded.~        3. Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap~          harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be~          maintained at 65-75dB. Session will stop if infant shows any signs of~          distress/agitation. Vital signs will be collected every 1-4 minutes during music~          session.~        4. After session behavior state using CRIES scale will be recorded.~        5. Family/caregiver will be given a questionnaire to fill out.~        6. 30 min of quiet will start.~        7. At the end of quiet time, behavior state and vital signs will be recorded for the last~          time.~   "
160199|NCT01469195|"~     During fluoroscopic imaging, diagnostic information is carried in the primary beam. These~     high intensity X-rays are the chief hazard to the patient. Lower energy scattered radiation~     deviates in all directions from the patient. Despite typical precautions (i.e., hanging a~     lead shield between the patient and the operator), many operators will be exposed to high~     radiation dose (higher than the permitted 50 miliS per year), this long term radiation~     exposure may result in stochastic and deterministic effects. The purpose of this study was to~     test the hypothesis that a non disposable radiation protection drape (that will cover the~     lower part of the patient) could help minimize the radiation scattered from the patient to~     the operator. In a procedure done through the Radial approach, there is a large portion of~     the patients (from the umbilicus and down) that is a source of scatter radiation to the~     operator. This portion can be covered with a lead rectangle. A non disposable, lead drape of~     uniform thickness will be inserted into a sterile nylon bag and will be used during~     fluoroscopic and cineangiography coronary angioplasty procedures. The lead drapes will cover~     the femoral puncture site. The widths and length of the drape is 50-60cm and 100 cm~     respectively and was shown not to hinder the field of radiation needed for fluoroscopy and~     cineangiography. (The upper border of the lead is under the patient's umbilicus and was shown~     not to interfere with the radiation field needed for angiography or angioplasty).~      The Investigators anticipate that the study will show a significant reduction in radiation~     exposure and hence reduce the radiation hazard to the operator.~   "
160200|NCT01469182|"~     This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in~     participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary~     objective was to compare treatment-emergent adverse events (AEs) for participants treated~     with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.~   "
160201|NCT01469169|"~     This study is to investigate the efficacy, safety, and Pharmacokinetics (PK) of Inhaled~     Iloprost (Ventavis) therapy in Japanese pulmonary arterial hypertension (PAH) patients in~     Main Treatment Phase (12 weeks) and to investigate the safety, tolerability, and efficacy of~     longterm Inhaled Iloprost (Ventavis) therapy in Japanese PAH patients in Extension Phase.~   "
160202|NCT01469156|"~     This Phase I/II study will investigate the safety and tolerability of intravitreally~     administered 0.5mg and 2.0mg Ranibizumab in three monthly doses followed by a 9 month period~     of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects~     with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.~   "
160203|NCT01469143|"~     This trial is conducted in Europe. The purpose of this trial is to compare the~     pharmacokinetic properties (the exposure of the trial drug in the body) of different~     formulations of NN1218.~   "
160204|NCT01469130|"~     In this study, MEK162 will be administered to Japanese patients with advanced solid tumors~     whose disease has progressed despite standard therapy or for whom no standard therapy exists.~     The trial will investigate the safety and tolerability and determine the MTD of MEK162 in~     Japanese patients.~   "
160205|NCT01469117|"~     This is a single center, prospective, non-randomized, uncontrolled, observational study of~     the use of an enteral nutrition product in pediatric patients with developmental~     disabilities.~   "
160206|NCT01469104|"~     The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results~     in a change in blood glucose that is similar to the change observed after 3 days of fasting.~   "
160207|NCT01469091|"~     The purpose of the study is to see whether intensive smoking intervention on the day of~     operation can reduce per- and postoperative complications in patients operated for acute~     ischaemic disease compared to control group with no intervention.~   "
160208|NCT01469078|"~     The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000~     (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney~     Disease on Dialysis Therapy (CKD-5D).~   "
160209|NCT01469065|"~     This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2~     diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and~     pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to~     wash off their diabetes medication for 4-6 prior to study drug administration, and they will~     remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of~     dosing, and some follow up tests.~   "
160210|NCT01469052|"~     The purpose of the study was to characterize the safety of investigational agent AG-013736,~     in patients with solid tumors in this First In Human trial.~   "
160211|NCT01469039|"~     The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or~     ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.~   "
160578|NCT01464216|"~     The purpose of the study is to combine and correlate data from morphological and functional~     MRI, molecular signatures of tumor hypoxia, the presence of micrometastases and tumor hypoxia~     with the goal being predicting of prostate cancer aggressiveness.~   "
160213|NCT01469013|"~     This is a Phase 2b, outpatient, randomized, double-blinded (with a single-blind extension),~     placebo-controlled, dose-ranging, parallel-group study of LY3009104 in Japanese participants~     with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy. LY3009104~     will be orally administered once a day with background methotrexate (6 to 16 mg/week) therapy~     for 12 weeks in the double-blind treatment period (1, 2, 4 or 8 mg/day, or placebo), and for~     52 weeks in the single-blind extension period (4 or 8 mg/day).~   "
160214|NCT01469000|"~     The purpose of this study is to compare the combination of pemetrexed and gefitinib versus~     gefitinib alone, in terms of progression-free survival. This study is in participants who~     have stage IV non squamous NSCLC with activating epidermal growth factor mutations and who~     have not had any previous chemotherapy for stage IV disease.~   "
160215|NCT01468987|"~     The purpose of this study is:~        -  To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after~          26 weeks of treatment.~        -  To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with~          insulin glargine during 26 weeks of treatment.~        -  To compare the number of participants on LY2605541 reaching blood glucose targets~          without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks~          of treatment.~        -  To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin~          glargine during 26 weeks of treatment.~   "
160216|NCT01468974|"~     The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance~     of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease~     of the superficial femoral (SFA) or common or external iliac arteries.~   "
160217|NCT01468961|"~     This pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. The~     purpose of the study is to evaluate an internet-based treatment protocol based on cognitive~     behavioral therapeutic principles. Participants are required to have a previous diagnosis of~     fibromyalgia before entering into the trial. The treatment will be 10 weeks long and all~     included participants will be given treatment, i.e. there is no randomization to a comparison~     group.~   "
160218|NCT01468948|"~     Background:~      - Essential tremor (ET) is a condition of out-of-control shaking. Several drugs are used to~     treat ET. However, they are often only partly helpful and can have side effects. Many people~     with ET get some relief from drinking alcohol. Octanol, a food additive similar to alcohol,~     can improve tremor in animals and is less likely to make people feel drunk. One form of~     octanol, called 1-octanol, has been shown to improve tremor in some people and had few side~     effects. 1-octanol is converted to octanoic acid, and research suggests that octanoic acid~     itself might suppress ET with no significant side effects such as drunkenness. Researchers~     want to see what dose of octanoic acid is most useful in reducing ET.~      Objectives:~      - To test different doses of octanoic acid to treat essential tremor.~      Eligibility:~        -  Individuals at least 21 years of age who have ET that responds to treatment with~          alcohol.~        -  Participants must be able to stop taking certain ET medications during the study.~      Design:~        -  This study requires three visits. Visit 1 is a screening visit that will take up to 5~          hours. Visit 2 is a 2- to 3-day inpatient admission to the National Institutes of Health~          Clinical Center. Visit 3 is a followup outpatient visit 1 to 2 weeks after the hospital~          admission.~        -  At the screening visit, participants will have a physical exam, neurological exam, and~          medical history. Blood and urine samples will be collected. Participants will also have~          an alcohol dose test to measure the tremor s response to alcohol.~        -  For the study visit, participants will enter the hospital for testing. Participants will~          have the study drug and test the tremor's response to it. Frequent blood samples will be~          collected.~        -  One to two weeks after leaving the hospital, participants will have a final followup~          study visit. Blood samples will be collected.~   "
160219|NCT01468935|"~     Background:~      - Some transplant recipients have been found to have cells in their uterus that come from the~     donor. Researchers want to study uterine tissue from three different groups of women: (1)~     healthy volunteers, (2) people who have had a stem cell transplant, and (3) people with rare~     diseases or conditions that affect reproduction. These samples will help researchers learn~     more about the way stem cells work in the reproductive tract.~      Objectives:~      - To collect cells from the uterus to study how stem cells work in the reproductive tract.~      Eligibility:~      - Women at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  Participants will have an endometrial biopsy to collect cells for study. The biopsy~          visit will take 1 to 2 hours.~   "
160220|NCT01468922|"~     Background:~      - Pazopanib is an anticancer drug that blocks the growth of new blood vessels in tumors. It~     has been approved to treat renal cell cancer. ARQ 197 is an experimental drug that blocks a~     protein called c-MET, which cancer cells need to grow. Studies suggest that some drugs that~     block blood vessel growth can increase the production of c-MET in tumors, which helps cancer~     cells keep growing. Blocking both blood vessel growth and c-MET with pazopanib and ARQ 197~     may help kill cancer cells faster. This study will use these drugs to treat solid tumors that~     have not responded to earlier treatments.~      Objectives:~      - To test the safety and effectiveness of pazopanib and ARQ 197 for advanced solid tumors.~      Eligibility:~      - Individuals at least 18 years of age who have advanced solid tumors that have not responded~     to earlier treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests, and imaging studies.~        -  The study drugs will be given in 4-week cycles of treatment. Participants will take~          pazopanib once a day and ARQ 197 twice a day by mouth. Some participants will start with~          pazopanib or ARQ 197 alone for the first week. Then they will take both drugs together~          for the rest of the study.~        -  Participants will be monitored with frequent blood tests and imaging studies. Optional~          tumor samples may be collected during different treatment cycles.~   "
160221|NCT01468909|"~     This randomized phase II trial studies how well paclitaxel when given together with or~     without pazopanib hydrochloride works in treating patients with ovarian epithelial, fallopian~     tube, or peritoneal cavity cancer that is persistent or has come back. Drugs used in~     chemotherapy, such as paclitaxel work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Pazopanib hydrochloride may stop the growth of tumor cells by blocking blood flow~     to the tumor or by blocking some of the enzymes needed for cell growth. It is not yet known~     whether paclitaxel is more effective when given with or without pazopanib hydrochloride in~     treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.~   "
160279|NCT01468142|"~     The purpose of this study is the observation of the course of~        -  the mechanics of the respiratory system~        -  the endexpiratory lung volume~        -  and the inflammatory response in patients undergoing treatment with extracorporeal life~          support (ECLS) due to severe refractory respiratory failure at our department.~   "
160280|NCT01468129|"~     This study will investigate the efficacy of using cell saver during bilater total hip~     arthroplasty~   "
160222|NCT01468896|"~     This phase I/II trial studies the side effects and best dose of recombinant interleukin-12~     when given together with cetuximab and to see how well they work in treating patients with~     squamous cell carcinoma of the head and neck that has come back, spread to another place in~     the body, or cannot be removed by surgery. Recombinant interleukin-12 may stimulate the white~     blood cells to kill tumor cells. Monoclonal antibodies, such as cetuximab, may interfere with~     the ability of tumor cells to grow and spread. Giving recombinant interleukin-12 together~     with cetuximab may kill more tumor cells.~   "
160223|NCT01468883|"~     Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to~     receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2)~     excisional biopsy, axillary dissection, and definitive irradiation.~      Data from single institutions and from retrospective comparisons suggest that definitive~     irradiation with cosmetically acceptable breast preservation offers survival and local~     control results equivalent to extirpative surgery. This study will test this hypothesis in a~     prospective, randomized manner. After primary therapy, subjects will be followed for: (1)~     survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and~     (5) cosmesis.~   "
160224|NCT01468857|"~     Background:~      - Stem cell transplants are a complex treatment that can have serious side effects. Having a~     caregiver to help with the recovery is critical. Serving in this role, however, can cause~     high stress levels and negative health effects. Researchers want to better understand the~     health effects of caring for a family member or friend after a stem cell transplant.~     Understanding these effects can help develop programs that support caregivers coping with the~     demands of post-transplant care.~      Objectives:~      - To study the physical and emotional health of caregivers for a family member or friend who~     has had a stem cell transplant.~      Eligibility:~        -  Individuals at least 18 years of age who are planning to be a caregiver for a person~          having a stem cell transplant.~        -  Healthy non-caregiver volunteers for comparison studies.~      Design:~        -  A caregiver will be caring for a transplant recipient just before transplant admission~          and up through 6 weeks after hospital discharge. The caregiver will usually live with or~          spend at least 6 hours each day with the recipient.~        -  All participants will have three study visits. The first visit will happen before the~          transplant. The second and third visits will happen at the recipient s discharge, and 6~          weeks after discharge. The following tests will be done at each visit:~        -  A health assessment with a physical exam and review of life events and current health~          problems~        -  Blood, hair, and saliva samples~        -  Questionnaires about stress levels, personal health, and the caregiving process.~        -  Caregiver participants may have an optional fourth study visit within 72 hours after an~          ICU admission. This visit will include the same tests as the other visits.~   "
160225|NCT01468844|"~     Background:~      - Central retinal vein occlusion (CRVO) is a blockage of the main vein that carries blood~     away from the retina in the back of the eye. It can lead to macular edema, a swelling of the~     retina that is a common source of vision loss. Studies suggest that inflammation might be a~     cause. Minocycline is a drug that might help prevent cells involved in inflammation from~     becoming activated. It is approved for use as an antibiotic, but it has not yet been tested~     to see if it can treat CRVO.~      Objectives:~      - To test the safety and effectiveness of minocycline as a treatment for central retinal vein~     occlusion.~      Eligibility:~      - Individuals at least 18 years of age who have central retinal vein occlusion in at least~     one eye, with vision between 20/32 and 20/200.~      Design:~        -  This study lasts 2 years, with at least 25 visits. Participants must agree to protect~          themselves from sunlight or artificial ultraviolet rays while in this study.~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and an eye exam. One eye will be selected as the study eye to receive~          the medicine.~        -  Participants will take minocycline or a placebo pill twice a day, about 12 hours apart,~          for 2 years.~        -  Participants will have monthly visits for blood tests and full eye exams to study the~          effect of the treatment. Other exams may include thyroid tests and eye imaging studies.~          Those in the study may also receive injections of a drug to prevent the growth of new~          blood vessels in the eye.~   "
160226|NCT01468831|"~     Background:~      - Branch retinal vein occlusion (BRVO) is a blockage of the small veins that carry blood away~     from the retina in the back of the eye. It often leads to macular edema, a swelling of the~     retina that is a common source of vision loss. Studies suggest that inflammation might be a~     cause. Minocycline is a drug that might help prevent cells involved in inflammation from~     becoming activated. It is approved for use as an antibiotic, but it has not yet been tested~     to see if it can treat BRVO.~      Objectives:~      - To test the safety and effectiveness of minocycline as a treatment for branch retinal vein~     occlusion.~      Eligibility:~      - Individuals at least 18 years of age who have branch retinal vein occlusion in at least one~     eye, with vision between 20/32 and 20/200.~      Design:~        -  This study lasts 2 years, with at least 25 visits. Participants must agree to protect~          themselves from sunlight or artificial ultraviolet rays while in this study.~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and an eye exam. One eye will be selected as the study eye to receive~          the medicine.~        -  Those in the study will take minocycline or a placebo pill twice a day, about 12 hours~          apart, for 2 years.~        -  Participants will have monthly visits for blood tests and full eye exams to study the~          effect of the treatment. Other exams may include thyroid tests and eye imaging studies.~          Those in the study may also receive injections of a drug to prevent the growth of new~          blood vessels in the eye.~   "
160250|NCT01468519|"~     Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males with~     diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with~     diabetes are afflicted with ED within 10 years of their diagnosis. Long-term poor glycemic~     control increases the risk ED. Although comparatively costly, advantages of CSII over other~     modes of insulin delivery include better glycemic control, fewer hypoglycemic episodes, and~     improved quality of life. In a previously published study, on CSII in T2DM, in our center,~     83% of men reported an improvement in sexual function as a secondary endpoint. The current~     study is planned to further explore this finding.~   "
165948|NCT01393613|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses~     of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of~     schizophrenia.~   "
160227|NCT01468818|"~     Background:~        -  The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy~          that involves taking white blood cells from patients' tumors, growing them in the~          laboratory in large numbers, and then giving the cells back to the patient with~          aldesleukin (IL-2) a drug that keeps the white blood cells active. These cells are~          called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment~          to over 200 patients with melanoma.~        -  This study will use chemotherapy to prepare the immune system before this white blood~          cell treatment. Our prior studies indicate that aldesleukin may not be required for cell~          transfer.~      Objectives:~      - To see if chemotherapy and white blood cell therapy without aldesleukin is a safe and~     effective treatment for metastatic melanoma.~      Eligibility:~      - Individuals at least 18 years of age and less than or equal to 70 years of age with~     metastatic melanoma.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the National Institute of~          Health (NIH) clinical Center and undergo a history and physical examination, scans,~          x-rays, lab tests, and other tests as needed.~        -  Surgery: If the patients meet all of the requirements for the study they will undergo~          surgery to remove a tumor that can be used to grow the TIL product.~        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the~          hospital for about 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up~          to 2 days.~   "
160228|NCT01468805|"~     Background:~      - Cockroach allergies are an important risk factor for asthma in inner-city households,~     especially in children. A new method for killing cockroaches may help children who live in~     households that have high numbers of cockroaches. Because most public health treatments~     target more than just cockroaches, this method could lower the costs of treating childhood~     allergies and asthma by focusing on the most likely source of the allergy.~      Objectives:~      - To test a new cockroach-killing method designed to reduce asthma in children exposed to~     cockroaches.~      Eligibility:~        -  Children 5 to 14 years of age who have moderate to severe asthma.~        -  Children must live in a household that has a high number of cockroaches.~      Design:~        -  Participants will be screened with a phone call and an initial home visit.~        -  Study doctors will place cockroach traps, and return after 3 days to check the number of~          roaches caught and killed. Dust samples will be collected from the house.~        -  Participants will have blood and lung function tests, and will be tested for allergies~          (including cockroach allergies).~        -  Some households will be treated for cockroaches at regular intervals, or more frequently~          if required by the study doctors.~        -  Participants will have regular checkup visits in their homes at months 1, 3, 6, 9, and~          12 and short phone call interviews at months 2, 4, 6, 8 and 10 to study their asthma~          symptoms. The home visits will also check the cockroach levels in the house....~   "
160229|NCT01468792|"~     The study serves the identification of early forms of pulmonary arterial hypertension (PAH)~     in connective tissue disease and the hemodynamic follow-up of the investigated patients. The~     basic hypothesis is that PAH may start with a remodeling of small pulmonary arteries, which~     leads to a stiffening of the vessels, indicated by the inability to vasodilatation and thus a~     disproportional increase in pulmonary pressure during exercise. Recent studies have shown~     that a proportion of such patients may develop manifest PAH within a few years. The early~     identification of these patients and the understanding of the natural course of the disease~     may improve prognosis. The aim of the present study is to investigate hemodynamic and~     clinical changes in patients with connective tissue disease in a time interval of 3-5 years~     with a focus on the development of pulmonary hypertension.~   "
160230|NCT01468779|"~     The purpose of this study is to evaluate the effect of the probiotic use in patients with~     periampullary cancers undergone curative or palliative treatment considering nutritional~     status, postoperative complications, infection rate, length of hospitalization and mortality.~   "
160231|NCT01468766|"~     The purpose of this randomized intervention study is to investigate the effects and~     biological mechanisms of a supervised 12-week progressive resistance training on fatigue and~     immunological and inflammatory biomarkers in breast cancer patients during adjuvant~     radiotherapy. To determine the effect of the exercise itself beyond potential psychosocial~     effects due to attention by trainers or the group support, patients in the control group have~     a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation~     training (Jacobsen method).~   "
160232|NCT01468753|"~     To evaluate the acceptability, feasibility, and efficacy of vaginal insemination as a method~     of conception in HIV discordant couples (female positive, male negative) desiring pregnancy~     in Kisumu, Kenya~   "
160233|NCT01468740|"~     Standard therapy for HIV-related Hodgkin lymphoma (HIV-HL) has not been defined. This trial~     was initiated to investigate a risk adapted treatment strategy in patients (pts) with HIV-HL~     as established in HIV-negative patients with HL.~      Treatment schedule:~        -  Early stage favorable Hodgkin Lymphoma (HL): 2 cycles of doxorubicin, bleomycin,~          vinblastine, and dacarbazine (ABVD) plus 30 Gy involved field (IF) radiation~        -  Early stage unfavorable HL: 4 cycles of bleomycin, etoposide, doxorubicin,~          cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline or 4~          cycles of ABVD plus 30 Gy IF radiation~        -  Advanced HL: 8 cycles of BEACOPP-baseline. BEACOPP should be replaced by ABVD in pts~          with far advanced HIV-infection. After the completion of chemotherapy sites of initial~          bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in~          diameter receive 30 Gy of irradiation.~        -  Primary outcome measure: tolerability, treatment-related mortality~        -  Secondary outcome measure: complete remission rate, progression-free survival (PFS),~          overall survival (OS).~   "
160248|NCT01468545|"~     Ventavis it's a treatment for pulmonary hypertension, administered by an inhaler called~     I-Neb.~      In these patients, the non compliance of the treatment becomes its ineffective and increases~     the complications and mortality of the disease.~      It is therefore important to know which the adherence of patients to their treatment is and~     try to promote it.~      One possibility to reach a good level of adherence is the patient education regarding the~     drug administration and also to comply as better is possible the recommendations of the~     physician.~      For this reason, the objective of our study is to demonstrate improvement in the level of~     treatment compliance when they follow a strategy of continuing education, assessed by the~     device and software called Insight.~      The only special procedure to participate in the study then is that patients involved could~     receive more training than usual.~      Investigators expect involving in this study around 50 patients in treatment with Ventavis~     and diagnosed of Pulmonary Arterial Hypertension in 10-12 hospitals throughout Spain.~      The patients who participated in the study will be followed for 12 months from inclusion in~     the study and will perform around 5 visits in total.~   "
160234|NCT01468727|"~     Mutans streptococci (MS) and lactobacillus species (LB) are the two groups of infectious~     cariogenic (caries-causing) bacteria most strongly associated with dental caries (dental~     decay). Infants acquire cariogenic bacteria from their mothers early in development via~     saliva. There have been several studies that have demonstrated a significant reduction in~     dental caries associated with consumption of the food additive known as xylitol in children~     and adults. Xylitol is a non-toxic 5 carbon polyol, approved as a food additive by the FDA,~     that tastes like and behaves like sucrose in humans. Xylitol is used as a sugar substitute to~     reduce dental caries as it is not fermentable by the caries causing bacteria. In addition, an~     observed positive beneficial side effect of this sugar substitute is that xylitol has been~     shown to reduce mother to child bacterial transfer when used by the mother. It is commonly~     recommended to wipe infants' teeth and gums with a soft cloth to reduce the formation of~     dental bacterial plaque. Recently wipes have been marketed that contain xylitol to provide a~     safe sweet sensation for the infant during this cleaning procedure. However, no study has~     been conducted that assesses the biological effect of applying xylitol directly to the teeth~     and gums of infants. This study will be conducted to test whether xylitol applied by swab~     directly to the infant's teeth and gums will effectively reduce bacterial transfer from~     mother to child. Children age up to two years old whose mothers have high cariogenic~     bacterial counts will be recruited to use xylitol wipes 3-4 times daily in addition to their~     normal preventive regimen. This will be a randomized double blinded study where the control~     group will receive placebo wipes (with no xylitol) and the experimental group will receive~     the xylitol wipes. The mother-child pair MS and LB bacterial counts and caries score of the~     children will be measured at baseline, 3 months, 6 months and 1 year. We will contact all~     patients that were recruited into the study to inquire whether they are willing to return for~     further follow-up visits at 1, 2, 3, and 4 years post-wipe treatment completion. If~     successful, this study will support the use of a simple caries preventive measure that could~     be easily and safely implemented in young children. Ten MS isolates and unique LB colonies~     will be isolated from each saliva samples to study their genetic diversities and virulence~     factors.~      The investigators will also investigate whether specific MS genes relate to ECC prevention~     effect of daily xylitol-wipe application using genomic sequencing of MS isolated from current~     study when the active intervention was applied.~   "
160235|NCT01468714|"~     This study will evaluate the potential for a drug-drug interaction of PF-04937319 with~     ketoconazole, a potent inhibitor of the drug metabolizing enzyme CYP3A.~   "
160236|NCT01468701|"~     In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at~     risk for stroke are enrolled to characterize the target population and to collect real world~     data on important outcome events. For administrative purposes the study is divided into two~     protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic~     Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled~     in both protocols is estimated to be 48,000 patients, and all these patients will be included~     in the data analysis for study 1160.129.~   "
160237|NCT01468688|"~     The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2~     dose of a combination of imatinib and BKM120 in the treatment of 3rd line GIST patients.~   "
160238|NCT01468675|"~     We evaluated whether collection of risk factors to generate an electronic health record~     (EHR)-linked personalized health risk appraisal (HRA) for coronary heart disease (CHD),~     diabetes, breast and colorectal cancer (CRC) was associated with improved patient-provider~     communication, risk assessment, and breast cancer screening plans in the next year.~   "
160239|NCT01468662|"~     The investigators propose to conduct a study to measure the reproducibility of CMR parameters~     that have been used to predict outcome following PPCI: infarct size, left ventricular~     volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.~   "
160240|NCT01468649|"~     The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph~     node (SLN) identification in patients with breast cancer using near-infrared (NIR)~     fluorescence optical imaging.~   "
160241|NCT01468636|"~     The purpose of this study is to examine the effect of 400 mg of oral zinc gluconate on~     genital warts. Our hypothesis is that there will be a 10% difference in complete clearance of~     genital warts in the group randomized to oral plus standard of care compared to those~     randomized to placebo plus standard of care.~   "
160242|NCT01468623|"~     The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU~     versus standard Body Surface Area (BSA) based administration of 5-FU in patients with~     metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to determine~     if the use of OnDose® achieves an improvement in the Overall Response Rate (ORR) relative to~     BSA dosing response.~   "
160243|NCT01468610|"~     This study will investigate the relationships between subjective cognitive complaints,~     neurocognitive deficits, and work productivity in participants with Major Depressive Disorder~     (MDD), before and after 8 weeks of treatment with an antidepressant medication. Our~     hypothesis is that, in working participants with MDD of at least moderate severity,~     neurocognitive deficits will predict poorer work functioning and productivity.~   "
160244|NCT01468597|"~     The aim of the study is to evaluate if there is an association between platelet inhibition~     and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual~     antiplatelet therapy.~   "
160245|NCT01468584|"~     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and~     Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous~     treatment.~   "
160246|NCT01468571|"~     The purpose of this study is to determine the effects of spironolactone on collagen markers~     in a large number of patients with pulmonary hypertension. In addition, safety and~     tolerability of spironolactone, an aldosterone receptor antagonist, in patients with~     pulmonary arterial hypertension, will be determined.~   "
160247|NCT01468558|"~     Compare the DHE pharmacokinetic profiles observed following administration of:~        1. MAP0004 (oral inhalation DHE)~        2. MAP0004 co-administered with oral Ketoconazole~        3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)~      Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of~     Ketoconazole.~   "
160249|NCT01468532|"~     This phase I/II trial studies the side effects and best dose of pasireotide and to see how~     well it works when given together with docetaxel and prednisone in treating patients with~     metastatic hormone-resistant prostate cancer. Drugs used in chemotherapy, such as docetaxel~     and prednisone, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Pasireotide may inhibit the secretion of~     hormones. Giving pasireotide together with docetaxel and prednisone may kill more tumor~     cells.~   "
160251|NCT01468506|"~     The purpose of this study is to analyze and identify pre-, intra-, and post- operative~     parameters that predict Steal-Syndrome with distal malperfusion after Arterio-Venous Fistulas~     (AVF) as primary endpoint. Secondary endpoints are pre-, intra-, and post- operative~     parameters that predict patency and fistula maturation.~   "
166238|NCT01389791|"~     Priming with either rocuronium or MgSO4 is known to accelerate the effect of rocuronium on~     muscle relaxation. The purpose of this study is to define the effect of MgSO4 on the~     rocuronium-priming.~   "
160255|NCT01468454|"~     Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these~     children may require surgery to remove part or all of their pancreas. In this study,~     researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine~     (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery.~     Eligible participants in this study will have positron emission tomography/computerized~     tomography (PET/CT) scans with F-DOPA prior to surgery.~   "
160256|NCT01468441|"~     The present prospective study was designed to compare the effects of administering a daily~     dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH~     agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated~     with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG)~     microdose.~   "
160257|NCT01468428|"~     In patients with Cystic fibrosis (CF) epithelial transport of chloride and sodium is~     disrupted in several organs such as airways, sweat glands, pancreas and intestines.~     Gastrointestinal symptoms are frequent but little is known about intestinal motility and~     function. Earlier studies using lactulose/hydrogen breath tests have found altered intestinal~     transit time. The method has several sources of errors and results have been questioned. This~     study is using a new, non invasive method to study intestinal motility patterns and transit~     times, Magnetic Tracking System - 1 (MTS-1).~      The aim is to compare patterns of contractility and transit times in the stomach and small~     intestine in adult CF- patients with healthy controls.~      Methods MTS-1 is performed without radiation and is associated with minimal discomfort for~     subjects. A small magnetic pill is ingest and detected by a matrix of sensors. Position and~     orientation of the magnet are defined by five coordinates (position: x, y, z, angle: φ, θ).~     Frequencies of slow waves as well as number and power of phase III contractions can be~     identified.~      Colorectal transit times are determined with a plain abdominal x-ray. The subjects are asked~     to ingest a capsule containing 10 radiopaque markers on six consecutive days up to~     examination. The total number of markers in the entire colorectum is counted. Total transit~     time, as well as segmental is calculated.~      Subjects 15 adult patients (> 18 years) with CF, homozygote for the mutation ΔF508, are~     studied. They are all pancreas insufficient (fecal elastase < 100 µg/g), with no previous~     intestinal resection or lung transplantation. None of them have diabetes. Patients are all in~     well-regulated pancreatic enzyme replacement therapy (PERT), thriving and with stabile weight~     over the last half year. They have had no treatment with antibiotics in the last 14 days up~     to the examination.~      The hypothesis is that patterns of contractility and transit times are the same for~     CF-patients in well -regulated PERT as for healthy controls.~   "
160258|NCT01468415|"~     The American Society of Anesthesiologists Task Force on Management, Chronic Pain section,~     recommended Phenol neurolysis when other techniques have failed to provide adequate pain~     control. In this study we sought to Compare the pain relieve on a Lower Back and Limbs~     obtained from Methylprednisolone and Phenol 8% Treatment given by Trans Sacral Approach. The~     study includes patients who suffers from a chronic low back and/or limbs pain which were~     referred to be given epidural as a treatment. Control group receives 80 mg Methylprednisolone~     while the test group receives phenol 8%.~   "
160259|NCT01468402|"~     The purpose of this study is to determine predictive factors in the pelvic magnetic resonance~     in the response of arterial embolization of uterine leiomyoma.~   "
160260|NCT01468389|"~     The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine~     With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer~     is effective and safe.~   "
160261|NCT01468376|"~     The purpose of this study is to determine a safe,tolerable and efficacious dose of GLU-xx.~   "
160262|NCT01468363|"~     There is no easily applicable method to determine extra cellular volume and consequently~     estimate DW. Thus DW has to be clinically defined by ''trial and error'' and several indirect~     methods.~      Recently, devices to measure DW by Bioimpedance spectroscopy (BİS) have become available.~     This non-invasive, cheap easily repeatable method has the potential to improve dialysis~     outcome in the majority of patients all over the world, The aim of the present project is to~     assess the feasibility of volume control by using a BİS device.~   "
160263|NCT01468350|"~     A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to~     evaluate the safety and tolerability and the effect of dalfampridine extended release (ER)~     tablets on sensorimotor function~   "
160264|NCT01468337|"~     Background:~      - In the eye disease central serous chorioretinopathy (CSC), fluid collects under the retina~     at the back of the eye. CSC can resolve on its own, but in some people it lasts for several~     months or can come back. The fluid buildup during CSC can cause vision loss. The drug~     interferon gamma-1b can help reduce fluid accumulation in the retina. Researchers want to see~     if interferon gamma-1b can help treat and prevent vision loss from CSC.~      Objectives:~      - To see if interferon gamma-1b eye drops are a safe and effective treatment for CSC.~      Eligibility:~      - Individuals at least 18 years of age who have CSC in at least one eye.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have an eye exam and blood tests.~        -  This study will require at least ten visits to the National Institutes of Health eye~          clinic over a total of 52 weeks (one year). Most visits will last up to 4 hours.~        -  Participants will return to the eye clinic 2 days after the first visit and 1, 2, 4, 8,~          12, 24, 36 and 48 weeks after starting the study eye drops. These visits will involve~          blood tests and eye exams.~        -  Participants will receive the study eye drops at the initial visit. The drops must be~          used three or four times a day for 2 weeks. They must be stored in a cool place (like a~          refrigerator). The doses will follow an escalation schedule with the first participant~          receiving 2 drops three times a day and the last participant receiving 4 drops four~          times a day. To maximize safety, the most-recently enrolled participant will complete~          Week 4 before the next participant can enroll (e.g., the second enrolled participant~          will not be enrolled until the first has completed the Week 4 visit).~        -  If the CSC does not improve after the first 2 weeks, participants will receive another 2~          weeks of eye drops. This set of drops will start 4 weeks after the initial study visit.~        -  If the CSC does not improve after the 8-week study period, participants may receive~          additional eye drops at the maximum dose of 4 drops four times daily.~        -  The study will end for each participant at one year (48 weeks after the initial study~          visit).~   "
160265|NCT01468324|"~     Background:~      - AZD7451 is a drug that may help interfere with brain tumor cell growth. It can prevent~     glioma cells from entering into normal brain tissue, and slow or stop the growth of~     additional tumors. Researchers want to see if AZD7451 is effective against gliomas that have~     not responded to surgery, radiation, or chemotherapy.~      Objectives:~      - To see if AZD7451 is a safe and effective treatment for gliomas that have not responded to~     standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have gliomas that have not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a physical exam, medical history, blood and urine~          tests, heart function tests, an eye exam, and imaging studies.~        -  Participants will take AZD7451 daily by mouth for 28-day cycles of treatment.~        -  Participants will keep a medication diary and record any side effects. Treatment will be~          monitored with frequent blood tests and imaging studies.~        -  Treatment will continue as long as there are no serious side effects and the tumor does~          not start growing again.~   "
160281|NCT01468116|"~     Roux-en-Y gastric bypass (RYGB) surgery induces resolution of type 2 diabetes, often within~     days after surgery and before significant weight loss. The aim of this study is to~     investigate whether changes in mitochondrial function contributes to the early improvement of~     type 2 diabetes after RYGB.~   "
160266|NCT01468311|"~     Background:~        -  Hodgkins lymphoma (HL) is a highly treatable cancer. However, if HL does not respond to~          chemotherapy or returns after chemotherapy, further treatments often are not successful.~        -  Some HL cells have a molecule called cluster of differentiation 25 (CD25) on the~          surface. Daclizumab is a drug that can detect CD25 on cells. In a treatment study for HL~          that did not respond to chemotherapy, daclizumab plus a radioactive atom called Yttrium~          90 helped kill these HL cells. Researchers want to combine this 90Y daclizumab with~          high-dose chemotherapy and stem cell transplant. This treatment may be more effective~          than the daclizumab alone.~      Objectives:~      - To see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can~     treat HL that has not responded to earlier treatments.~      Eligibility:~      - Individuals at least 18 years of age who have Hodgkins lymphoma that has not responded to~     chemotherapy.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  Participants will have filgrastim and plerixafor to move stem cells into the blood. Stem~          cells will be collected with apheresis.~        -  Four weeks after stem cells are collected, participants will have the 90Y daclizumab and~          normal daclizumab to treat the HL. Chemotherapy will start 9 days after the first~          treatment.~        -  Most participants will have a second dose of 90Y daclizumab 6 weeks after the first~          dose.~        -  After each daclizumab treatment, participants will have several imaging studies of the~          chest and abdomen. Blood samples will also be collected.~        -  On the day after the last day of chemotherapy, participants will receive the stem cells~          collected earlier. Filgrastim injections will help stimulate stem cell growth....~   "
160267|NCT01468298|"~     The aim of this study was to investigate the changes in posture, flexibility, muscle~     strength, functional capacity, heart rate(HR), peripheral oxygen saturation, systolic blood~     pressure, diastolic blood pressure and intensity of pain in chronic low back pain underwent~     to Isostretching and GPR.~   "
160268|NCT01468285|"~     Betahistine may provide benefit by enhancement of Cerebral Blood Flow (CBF). This~     placebo-controlled pharmacodynamic treatment study will primarily explore the effect of~     betahistine on cerebral blood flow measured by dynamic contrast-enhanced MRI imaging, in a~     patient population with MRI evidence of cerebrovascular compromise. Also it will be measured~     if CBF changes correlate with gait and cognitive changes.~   "
160269|NCT01468272|"~     This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of~     Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation~     already approved in adults.~   "
160270|NCT01468259|"~     This study will be an open-label, single-treatment, single-dose, parallel group study to~     evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe~     renal dysfunction and End Stage Renal Disease (ESRD) after a single dose compared to matched~     healthy subjects with normal renal function.~      A total of 48 male or female subjects, 16 subjects with normal renal function (eGFR greater~     than 90 mL/min/1.73m²) and eight each (8) with mild (60 less than eGFR less than 89~     mL/min/1.73m²), moderate (30 less than eGFR less than 59 mL/min/1.73m²), or severe (15 less~     than eGFR less than 29 mL/min/1.73m²) renal impairment or ESRD (eGFR < 15 mL/min/1.73m² and~     requiring hemodialysis) will be selected according to the inclusion and exclusion criteria.~     The medical and laboratory examinations will take place within 28 days before dosing. A~     single dose of 600 mg of droxidopa as an investigational drug will be administered with 240~     mL of water after an overnight fast (minimum 10 hours).~      Blood samples for the measurement of plasma concentrations of droxidopa and metabolites~     including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be~     collected before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours after dosing~     for healthy volunteers and subjects with mild, moderate, and severe renal impairment and~     those with ESRD. For the latter, samples will be collected on both a non-hemodialysis and a~     hemodialysis visit.~      During dialysis, samples of dialysate, from the arterial and venous sides of the dialyzer~     will be collected at 30-minute intervals during the dialysis period. In addition, the entire~     dialysate will be collected, its volume recorded, and a sample retained for the measurement~     of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and~     protocatechuic acid concentrations.~      Urine samples for the measurement of urinary excretion of droxidopa and metabolites including~     but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be collected~     before and over the following intervals after dosing: 0 2, 2-4, 4-6, 6-8, 8-12, 12-24, and~     24-36 hours for healthy volunteers and subjects with mild, moderate, and severe renal~     impairment.~      A post-study visit with physical examination and laboratory tests will take place within~     seven (7) days after the last PK blood sampling.~   "
160271|NCT01468246|"~     The investigators are conducting a longitudinal cohort study of young women with breast~     cancer. The investigators identify women age 40 and younger with newly-diagnosed breast~     cancer from academic and community healthcare institutions. After women consent to the study,~     they fill-out surveys and give blood samples, and the investigators collect tissue from their~     breast cancer tumor after it is removed. Women are surveyed every 6 months for the first 3~     years after diagnosis, then yearly thereafter for an additional 7 years (for a total~     follow-up of at least 10 years following diagnosis). The study investigates short and~     long-term disease and treatment issues, tumor biology and the relationship to patient~     outcomes, and psychosocial concerns at baseline and in follow-up among a cohort of young~     women who are newly-diagnosed with breast cancer.~   "
160272|NCT01468233|"~     A study to evaluate the safety and efficacy of treatment with adalimumab in adults with~     moderate to severe hidradenitis suppurativa (HS).~   "
160273|NCT01468220|"~     The patient numbers with metabolic syndrome and diabetes have doubled in the last decade.~     Data that physical exercise ameliorates the metabolic syndrome are convincing, although the~     mechanisms of the effect in man are not clear. Numerous endocrine or molecular mechanisms~     modified by physical exercise are known to be hypoxia-sensitive, i.e. by hypoxia-inducible~     factor-1 (HIF-1) regulation. Thus, relative hypoxia may link physical exercise and~     modification of endogenous metabolism. Medical communities seem ill equipped to address the~     primary issues involved. The investigators have experience with normobaric hypoxia chambers~     and will now test a (physical exercise) training program, using state-of-the-art assessments~     available nowhere else in Germany. The investigators will compare hypoxia chamber, to ambient~     training, to test the notion that specific exercise conditions could regulate specific~     molecular pathways involved in the pathogenesis of the metabolic syndrome. Indeed, hypoxia~     chamber training could be superior to conventional training in terms of reducing~     cardiovascular risk factors or improving fitness. The investigators will test overall~     metabolism-related effects with a metabolic chamber. The investigators will test local~     metabolism with microdialysis during exercise routines, and the investigators will perform~     fat and muscle biopsies to investigate tissue-related effects. The investigators include~     experience from a broad-ranging spectrum. The investigators findings might improve~     understanding mechanisms linking physical exercise and endogenous metabolism. Furthermore,~     they could influence decision-making regarding non-pharmacological interventions.~   "
160274|NCT01468207|"~     A study to evaluate the safety and efficacy of treatment with adalimumab in adults with~     moderate to severe hidradenitis suppurativa (HS).~   "
160275|NCT01468194|"~     In this investigation the researchers explore whether different types of breathing procedures~     can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain~     sickness or a high altitude pulmonary edema.~   "
160276|NCT01468181|"~     This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study~     in participants with type 2 diabetes mellitus who have inadequate glycemic control with~     monotherapy of oral antihyperglycemic medication (OAM).~   "
160277|NCT01468168|"~     To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye~     disease.~   "
160278|NCT01468155|"~     It is hypothesized that peri-ablation Dabigatran will be a safe and effective method of~     peri-procedural anticoagulation for Atrial Fibrillation (AF) ablation, resulting in a low~     rate of peri-procedural bleeding and thromboembolic complications.~   "
160282|NCT01468103|"~     This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and~     surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle~     closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for~     3 years.~   "
160283|NCT01468090|"~     The aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562~     adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in~     order to evaluate the consequences of biological therapy in the treatment of IBD. The cohort~     is established after the implementation of biological agents in the treatment of IBD and the~     investigators hypothesis is that a) Severe disease course in IBD can be predicted by~     phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to~     be used as guidance in the selection of treatment strategy and b) Introduction of biological~     treatment changes the course of disease in IBD and reduces the need of surgical procedures.~      Methods: Medical records will be reviewed to register the use of medication, flare ups~     (medical and surgical) and hospital admissions. Diagnosis, disease localization and behavior~     will be evaluated. At outpatient visits patients will get a clinical examination, blood and~     faeces will be collected to biobank and patients will be offered an endoscopical examination.~     The Montreal classification, The Harvey & Bradshaw's activity index (CD) and the SCAAI score~     (UC) will be used to describe disease localization, extent, behavior and severity. An~     electronic database will be established in use of processing data.~   "
160284|NCT01468077|"~     This multi-center, randomized, parallel-group, active-controlled, open-label study will~     evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time~     compared to the normal infusion time. Patients will be randomized to 8 mg/kg~     RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg~     infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.~   "
160285|NCT01468064|"~     The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous~     transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial~     progenitor cells (EPCs) for treatment of patients with ischemic stroke.~   "
160286|NCT01468051|"~     Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled~     and this could improve seroconversion rate of hepatitis B vaccination.~      In this study, the investigators aimed to compare seroconversion rates and immune response~     rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B~     surface antigen (HBsAg) vaccine given to predialysis CKD patients.~   "
160287|NCT01468038|"~     This is a double blind placebo controlled study of one hundred and four subjects which will~     be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone~     and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups.~     Each of the one hundred and four subjects will undergo baseline examination to include a~     sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and~     four subjects will then be randomly placed in one of the four groups.~   "
160288|NCT01468025|"~     This research protocol will compare Theramine to a non-steroidal anti-inflammatory drug~     (NSAID) in the treatment of chronic back pain. The study will examine the efficacy and~     tolerability of Theramine alone in patients with chronic back pain in comparison to the~     NSAID, Naproxen, and the co-administration of Naproxen with Theramine.~   "
160289|NCT01468012|"~     The proposed study will look at cocaine dependent individuals and will consist of three~     consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy~     will be administered; 2) the 15-21 day inpatient phase (during which participants will start~     study medication of levodopa,carbidopa and entacapone (LCE) and will undergo brain imaging~     and 3) the 24 weeks outpatient treatment trial. The purpose is to see if treatment with LCE~     may reverse baseline brain deficits and if this change is associated with clinical~     improvement. Hypothesis is that treatment with LCE, compared to placebo, increases abstinence~     from cocaine over a 12-week trial in combination with behavioral treatment with voucher~     incentives.~   "
160290|NCT01467999|"~     The purpose of this study is to determine whether guanfacine represents a tolerable,~     potentially effective pharmacotherapy option for cannabis dependence. Interested in seeing~     whether guanfacine treatment reduces marijuana consumption, withdrawal symptoms, and craving~     as compared to baseline.~   "
160291|NCT01467986|"~     Children, adolescents and young adults with high risk relapsed or treatment refractory~     neuroblastoma (rNB) represent a group of patients with dismal prognosis for whom a~     recommended standard salvage therapy is currently not available.~      The multimodal metronomic approach combining molecular targeted drugs (rapamycin and~     dasatinib) with conventional chemotherapy (irinotecan and temozolomide) will be investigated~     in a randomized fashion as new treatment strategy for patients with rNB. The intention is to~     assess the therapeutic benefit of molecular targeted drugs for the treatment of rNB.~      The combination of irinotecan and temozolomide showed activity in the treatment of several~     solid organ tumors, brain tumors and neuroblastoma. In one study rNB patients received a~     median of 5 courses of 5 days irinotecan and temozolomide every 3 to 4 weeks with a~     cumulative dose of 35% lower than in the RIST design. 33% had disease regression with 8% CR~     or PR. A phase II study in rNB also using irinotecan and temozolomide with a substantially~     lower intensity showed a response rate of 15%.~      The combination of a mTOR inhibitor with a multi-kinase inhibitor demonstrated in preclinical~     studies a synergistic effect on cell cycle arrest, apoptosis and sensitization for radio- and~     chemotherapy. It is assumed that this combination of molecular targeted drugs with a~     tolerable conventional chemotherapy consisting of irinotecan and temozolomide can~     substantially improve the outcome of this patient population. A group of 20 rNB patients~     treated with the RIST therapy approach in a compassionate use setting showed an overall~     survival of 55% at a median of 80 weeks with a tolerable adverse event profile.~   "
160322|NCT01467570|"~     It is generally recommended that oral rehydration should be used as first-line therapy to~     treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink~     regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended~     treatment.~      The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a~     new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN~     in children with acute gastroenteritis (AGE).~   "
160292|NCT01467973|"~     The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a~     multinational , multicentre, prospective, observational, hospital-based registry of patients~     with acute heart failure(AHF) with 3 month and one year follow-up.~      Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure~     particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable~     medical practices and heart failure management setup in the Gulf region, AHF patients in the~     Gulf states are expected to have different presentation and receive different management than~     patients in European countries resulting in different outcome. It is also hypothesized that~     there is considerable gap between heart failure management guidelines and clinical practices~     in the Gulf region.~   "
160293|NCT01467960|"~     In Italy affected people are 200,000 and every year Parkinson new cases are 10,000. Aging is~     the principle risk factor of Parkinson with the possibility of its development doubling every~     five years after 65. Because of the increase of the social longevity and aging as the main~     risk factor, there are many repercussions on the health system (hospital stays and~     pharmaceutical costs) as on the social system (assistance- related problems). Parkinson's~     disease exerts an extremely negative impact on life's quality of the patient. In fact,~     because of Parkinson symptoms (tremor, dribble, etc), patient's social life will be reduced~     with the consequent development of the depression. Consequently, the early detection and~     treatment of Parkinson's is necessary.~      To achieve this goal, Apolipoprotein D (ApoD) in human serum as a marker of the oxidative~     stress-inflammation vicious cycle seems most promising candidate for diagnosis.~   "
160294|NCT01467947|"~     This is a prospective, international, multi-center, non-randomized, single arm, open-label,~     postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE~     subjects treated intravenously with Berinert. Individual treatment duration per subject is 9~     months, irrespective of the number of treated attacks. All subjects will receive 20 IU~     Berinert/kg body weight per attack.~   "
160295|NCT01467934|"~     In this study, the investigators will prospectively assess fever rates and other associated~     vaccine adverse events in 6-23 month old patients during days 0-7 after administration of~     trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine~     (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine~     (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly. The~     investigators hypothesize that fever rates will be significantly higher during the 0-1 days~     after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal~     conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered~     non-concomitantly.~   "
160296|NCT01467921|"~     Oxaliplatin is a platinum analogue that has significant antitumor activity with better~     tolerability than cisplatin. The objective of the study is to evaluate the safety and~     activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin~     combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive~     esophageal cancer.~   "
160297|NCT01467908|"~     It has already been demonstrated that mental imagining of the complex motor act, such as limb~     lifting, can evoke the activation of the involved motor centres even if it doesn't result in~     movement due to paresis. Aim of the study: using the navigated brain stimulation system~     create a new diagnostic model for the differential diagnostics between the vegetative state~     and the minimally conscious state. If the investigators could get from patient the efferent~     motor response after a verbal command, his level of conscious should not be defined less than~     the minimally conscious state.~   "
160298|NCT01467882|"~     The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg~     6-month formulation in 44 patients suffering from central precocious puberty. The total study~     duration per patient will be 12 months (48 weeks).~   "
160299|NCT01467869|"~     Following spinal cord injury, most men are infertile and require medical assistance to father~     children. The conditions that contribute to their infertility are erectile dysfunction,~     ejaculatory dysfunction, and semen abnormalities. The Miami Project Male Fertility Program is~     a research study designed to understand and improve impairments to male fertility resulting~     from spinal cord injury.~   "
160300|NCT01467856|"~     Sleep-disordered breathing (SDB) occurs in 2% to 4% of the non-disabled adult population and~     is characterized by periods of complete breathing cessation (apnea) or marked reductions in~     airflow (hypopnea) during sleep. By contrast, the diagnosis of SDB affects as many as 83% of~     persons with tetraplegia within one year of their injury. While some consider daytime~     somnolescence from poor sleep quality a 'tolerable annoyance', SDB can decrease near-term~     physical performance and mental alertness, decay memory and intellectual processing, invoke~     mood disturbances, decrease healthrelated quality of life(HRQoL), and cause vehicular or~     occupational injury. Recurrent sleep arousal is now strongly associated with cardiometabolic~     (CM) component risks including insulin resistance, obesity, inflammatory stress, and~     endothelial dysfunction. Despite considerable advancements in understanding and treating SDB~     - including favored use of positive airway pressure (PAP) - an evidence base sufficient to~     warrant routine evaluation and treatment of SDB and related sleep disorders remains elusive~     for those with spinal cord injury (SCI). To address these knowledge and treatment~     shortcomings the investigators will conduct a hypothesis-driven study with specific aims that~     will: 1) describe by stakeholder survey the clinically-relevant determinants of sleep quality~     in persons with chronic tetraplegia, 2) assess clinical features and co-morbid risks~     associated with SDB in persons with tetraplegia, and 3) determine in persons with tetraplegia~     having SDB whether treatment using PAP reduces health risks and improves HRQoL. Hypothesis 1~     will be tested using data derived from a website survey.~   "
160301|NCT01467843|"~     Although national expenditures on back pain treatments have increased substantially over the~     past decade, the health and functional status of persons suffering from back pain has~     deteriorated. This trial will evaluate the effectiveness, and cost-effectiveness, of a safe~     and relatively inexpensive mind-body therapy that has the potential to provide relief to~     some of the millions of Americans who continue to suffer from chronic back pain.~   "
160302|NCT01467830|"~     The purpose of this study is to determine the efficacy of mesh fixation using absorbable~     versus non-absorbable sutures.~   "
160303|NCT01467817|"~     The purpose of this study is to determine how exercise and nutritional guidance and~     supplementation affects your physical fitness, risk for heart disease, your body's ability to~     burn fat, and your opinions about your health.~   "
160304|NCT01467804|"~     This is a randomized, double-blind multi centric clinic study. Both of therapist and patient~     are blind. There are 180 patients from 3 hospitals included, who meet DSM-IV criteria for~     major depressive disorder, the score of HAMD-item＞20，＜35；and meet the criteria for TCM~     syndrome of Liver Qi stagnation and Transformation of Stagnant Qi into Fire. Patients are~     randomized to JWXY and sertraline treatment groups, receiving oral sertraline (start with 50~     mg/day for one week then continue with 50 mg/day) plus placebo of JWXYJN; or oral JWXYJN plus~     placebo of sertraline daily for 2 months. The symptoms of depression and anxiety are measured~     with HAMD and HAMA tests at baseline and at 2，4，8 weeks; and LFT, BUN, Cr are assessed at~     baseline and end of program. Then data will be analyzed with SPSS software to determine the~     efficacy and safety of JWXYJN comparing to sertraline in the treatment of mild to moderate~     major depressive disorder.~   "
160305|NCT01467791|"~     Registry to follow patients with sarcoidosis associated pulmonary hypertension~   "
160306|NCT01467778|"~     This is a Phase I study to assess the safety of three formulations of the dermal implant~     ELAPR.~   "
160307|NCT01467765|"~     In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been~     speculated as a cause of aspiration pneumonia. Elemental diet may facilitate gastric emptying~     in PEG patients as compared with regular liquid enteral nutrients, resulting in the~     prevention of aspiration pneumonia.~   "
160308|NCT01467752|"~     Traumatic cartilage loss of the joint is central to the development of joint failure in~     arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal~     joint defects.~   "
160309|NCT01467739|"~     The purpose of this study is to evaluate a disposable fiberscope (Ambu ® aScope®) for~     tracheal intubation in difficult airways due to cervical immobilization by a cervical collar,~     and compare it to a conventional reusable fiberscope.~   "
160310|NCT01467726|"~     This is a Phase 1, Randomized, Placebo−Controlled, Double−Blind, Study of Safety,~     Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.~   "
160311|NCT01467713|"~     The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly~     before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in~     adult patients.~   "
160312|NCT01467700|"~     The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily~     (QD), sublingual (SL), in adult participants with acute depressive episodes associated with~     Bipolar I disorder.~   "
160313|NCT01467687|"~     The purpose of this study is to determine the bioequivalency of Synerx Pharma Verapamil~     extended release capsules.~   "
160314|NCT01467674|"~     The aim of this study was to investigate the impact of glycemic control on clinical~     periodontal status, levels of malondialdehyde (MDA), glutathione peroxidase (GSH-Px), reduced~     glutathione (GSH) and paraoxonase (PON) activity in gingival crevicular fluid (GCF) and blood~     samples of type 2 diabetes mellitus (T2DM) patients with chronic periodontitis (CP).~   "
160315|NCT01467661|"~     The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308~     and, in the opinion of the Investigator, will continue to benefit from treatment.~   "
160316|NCT01467648|"~     This is prospective and randomized study to assess the pharmacodynamics (t>MIC) of 0.5 g~     every 8 h of doripenem in patients with VAP following administration by a 4 h infusion or 1 h~     infusion.~      Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE~     II score, BUN, Cr, Blood culture will be collected.~      Twelve patients will be enrolled in this study. After completion of the doripenem therapy for~     3 days in this study, all patients will receive other sensitive antibiotics to eradicate~     their bacterial infections.~      Doripenem pharmacokinetic study will be carried out during the doripenem therapy. Blood~     samples (approximately 2 ml) in group  0.5 g of doripenem with 4 h infusion every 8 h~     regimen will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4,~     4.5, 5, 6, 7 and 8 h after 7th dose of doripenem.~      Blood samples (approximately 2 ml) in group  0.5 g of doripenem with 1 h infusion every 8 h~     regimen will be obtained by direct venepuncture at the following time: 1, 1.5, 2, 4, 5, 6, 7~     and 8 h after 7th dose of doripenem.~      The doripenem assays by method of Ikeda K et al. (J Chromatogr B, 2008) will be performed.~      Concentration of doripenem in plasma will be simulated in Monte Carlo technique (Computer~     model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment)~     and %CFR (Cumulative Faction Response)~   "
160317|NCT01467635|"~     A prospective diagnostic clinical study randomising patients undergoing endobronchial~     ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and~     hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps~     (EBUS-TBNB).~      The study aims to establish whether the use of EBUS-TBNB can significantly increase the~     diagnostic yield over EBUS-TBNA, without an increase in complication rates.~   "
160318|NCT01467622|"~     The effect of local chest-tube management protocols on the duration of chest-tube therapy~     following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units.~     The primary study objective was the duration of chest tube therapy in postoperative patients.~   "
160319|NCT01467609|"~     Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The~     aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate~     patients with ulcerative colitis and reach high consistency to conventional colonoscopy.~   "
160320|NCT01467596|"~     The aim of this study is to determine the minimum effective volume of local anesthetic (50:50~     mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective US-SCB for~     surgical anesthesia in 50% of patients and to calculate the effective volume required to~     produce an effective US-SCB in 95% of the patients (MEAV95) in elderly group (>65 years) and~     in middle aged group (<45years) of patients.~   "
160321|NCT01467583|"~     The primary objective of this study is to determine whether a dose-adjusted prophylaxis~     fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours~     (hr) in patients with renal failure achieves peak and trough levels similar to patients with~     normal renal function, and protects patients from developing venous thromboembolism (VTE).~     Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing~     interval from q24 to q48 hr, in patients with estimated creatinine clearance of < 30 ml/min,~     will be safe and effective.~   "
160324|NCT01467544|"~     Tai chi intervention may lead to relaxation and could potentially reduce the risk of~     cardiovascular disease. This project entails a comprehensive and innovative approach for~     understanding, measuring, and potentially reducing cardiovascular risk in women. The goal of~     this area of research is to reduce cardiovascular risk and perhaps reduce illness and death.~   "
160325|NCT01467531|"~     This will be a single-center, two-cohort, three-period study in healthy adult subjects.~     Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14~     evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide~     data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to~     the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after~     the last dose of study drug. There will be a washout period between Period 1 and Period 2 but~     no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last~     day in Period 2. The study will be conducted on an out-patient basis except for days where~     serial pharmacokinetic sampling and safety assessments are scheduled.~   "
160326|NCT01467518|"~     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3~     clinical development for the treatment of HIV infection. As HIV-infected subjects may also be~     receiving methadone for opioid dependence, an evaluation of the potential interaction between~     DTG and methadone is warranted. The primary objective of this study is to determine whether~     concomitant administration of DTG can affect the pharmacokinetics (PK) of methadone. As a~     secondary endpoint, the PK of DTG will be compared to historical data. This study will be~     open-label with subjects receiving DTG and stable doses of methadone. The study will be~     conducted at one center in Canada in adult male and female subjects.~   "
160327|NCT01467505|"~     To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and~     ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen~     following liver transplantation.~   "
160328|NCT01467492|"~     The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination~     with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in~     treatment-experienced Black/African American and non-Black/African American participants with~     Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a~     prior course of interferon-based therapy.~   "
160329|NCT01467479|"~     The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C~     Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a~     (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic~     acid (HCV RNA) 12 weeks after the last planned dose of study drug.~   "
160330|NCT01467466|"~     The purpose of this research study is to compare the effectiveness of intravenous isotonic~     sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine with~     oral placebo for the prevention of serious adverse outcomes following angiographic procedures~     in high-risk patients.~   "
160331|NCT01467453|"~     The study objective is to investigate the clinical applicability of continuous IOP~     measurement using TS with radio transmission over 24 hours.~        -  Trial with medical device~   "
160332|NCT01467440|"~     Retrospective analysis of efficacy of selective laser trabeculoplasty in patients under~     treatment with topical prostaglandins compared to patients without topical prostaglandins is~     performed.~      Inclusion criterion are patients with glaucoma or ocular hypertension, who underwent~     treatment with selective laser trabeculoplasty due to insufficient control of intraocular~     pressure during their routine treatment at the University Hospital Zurich / Division of~     Ophthalmology.~   "
160333|NCT01467427|"~     This trial is conducted in Asia, Europe and North America. The aim of the trial is to~     evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body)~     of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with~     Haemophilia B.~   "
160334|NCT01467414|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250~     (insulin degludec) in Japanese subjects with type 2 diabetes.~   "
160335|NCT01467401|"~     This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and~     safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard®~     30) in subjects with type 2 diabetes.~   "
160336|NCT01467388|"~     Retrospective analysis of efficacy of selective laser trabeculoplasty in pseudophakic~     patients compared to phakic patients is performed.~      Inclusion criterion are patients with glaucoma or ocular hypertension who underwent treatment~     with selective laser trabeculoplasty due to insufficient control of intraocular pressure~     during their routine treatment at the University Hospital Zurich / Division of Ophthalmology.~   "
160337|NCT01467375|"~     This trial is conducted in Oceania and North America. The aim of this trial is to assess the~     long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes~     who have completed the BIAsp-1234 trial.~   "
160338|NCT01467362|"~     Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local,~     immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are~     dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is~     associated with skin barrier dysfunction that facilitates an easier allergen penetration into~     the skin with an increased irritation and subsequent cutaneous inflammation. A lack of~     important stratum corneum intercellular lipids and an inadequate ratio between compounds~     enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy~     usually twice daily improves dryness and subsequently pruritus during the treatment of atopic~     dermatitis and especially improves the barrier function. Emollients make part of basic~     therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and~     Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration,~     measured by skin hydration, is a key element for evaluation of emollient treatment efficacy.~      The primary objective of this study is to demonstrate the efficacy of the tested product~     (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient~     formula during 28 days.~   "
160446|NCT01465958|"~     The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and~     tolerability of subcutaneously (SC; under the skin) administered GAMUNEX-C compared to~     intravenously (IV; through the vein) administered GAMUNEX-C in subjects 2-16 years of age~     with Primary Immunodeficiency.~   "
160339|NCT01467349|"~     This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as~     part of an optimized therapy in a clinical setting.~      Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the~     date of discontinuation of the considered regimen or the date of last visit or the date of~     lost to follow-up, whichever came first.~      The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing~     regimens in a urban clinic setting.~   "
160340|NCT01467336|"~     Through a prospective randomized study the aims of this study is to analyze the impact of 3~     types of rehabilitation protocols on the Optimization of the post-operative clinical and~     anatomic healing of the rotator cuff. After an arthroscopic repair of a stage 1 or 2~     supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per group):~        -  strict immobilization for 6 weeks then active rehabilitation,~        -  or 3 weeks of immobilization then 3 weeks of passive motion before active~          rehabilitation,~        -  or immediate passive motion for 6 weeks and then active rehabilitation.~      Patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an~     arthro-CT will be performed at 1 year.~      The investigators will evaluate: constant score and rate of tendon healing.~   "
160341|NCT01467323|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and~     safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.~   "
160342|NCT01467310|"~     Research into treatments for breast cancer relies more and more on an understanding of how~     the cells of tumor tissue act when they are exposed to a new or different drug. To find these~     new or different drugs to treat cancer, researchers are looking at proteins that help cancer~     cells grow, such as a group of proteins called Kinases. In this study the investigators want~     to look at the activity of kinases when a particular experimental drug called GSK1120212 is~     administered. GSK1120212 blocks a kinase called MEK. GSK1120212 is not yet approved by the~     FDA for use in breast cancer patients. The investigators want to give subjects GSK1120212 for~     a short period of time (one week) to see how MEK and the other kinases function in cancer~     cells both before and after the study drug is given. This study is not intended to treat~     cancer, it is looking at ways that the investigators may treat cancer in the future.~   "
160343|NCT01467297|"~     40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be~     enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be~     compared, ceftidoren 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days.~     Primary objective of the study is to evaluate the effects of the treatment on serum~     inflammatory biomarkers and the secondary objective is to evaluate the clinical and~     microbiological efficacy at the Test Of Cure visit (TOC), DAY 7-10 (end of treatment).~      The study foresees 4 visits: Visit 1 (enrolment, day 1 of treatment); Visit 2 (day 2-4);~     Visit 3 (Test Of Cure-TOC visit, day 7-10 end of treatment), Visit 3 (Late Post Therapy~     assessment, Day 28-30).~      The primary parameter to test the efficacy of the study medications will be the assessment of~     the speed of reduction of inflammatory parameters (CRP, PCT and KL6). Every reduction of 10%~     will be taken into account. The comparison between treatments will be performed at visit 2~     and 3.~   "
160344|NCT01467284|"~     The proposed site-level randomized trial will test the effectiveness of a work site~     intervention based on an ecological framework at preventing weight gain among high school~     employees in Massachusetts. The investigators hypothesis is that the intervention will~     positively impact healthy dietary patterns and physical activity, perceived organizational~     commitment, coworker influences, social support, self-efficacy, and self-control, which in~     turn will positively mediate or moderate the positive associations between the intervention~     and the primary outcomes (change in weight, BMI, and waist circumference). If effective, the~     intervention is designed to be generalizable to high school settings across the country and~     has the potential to reduce the morbidity, mortality and economic costs of overweight and~     obesity in this important population.~   "
160345|NCT01467271|"~     The main purpose of this study is to prospectively estimate the incidence of NSF in patients~     with moderate to severe renal impairment after administration of DOTAREM®~   "
160346|NCT01467258|"~     Amantadine appears to be a specific substrate for acetylation by spermidine/spermine~     N1-acetyltransferase (SSAT). SSAT activity in cancer cells is higher by several-fold compared~     to normal cells. Amantadine can be used to determine SSAT cellular activity, and may indicate~     the presence of cancer.~      This study will provide additional information in conjunction with data from a previous study~     which include cancer patients and normal health age matched controls to determine whether~     urinary excretion of acetylamantadine is predictive for the presence of cancer, and if so~     whether excretion of this metabolite is associated with any particular site of the tumor.~     Based on the results of the first study additional data in normal healthy volunteers is~     required.~      The data from both studies will be analyzed to account for subject gender, stage of disease~     at time of testing, concurrent diseases, alcohol and tobacco use and occupational~     characteristics. This is an important first step in validating a cancer detection method that~     can be implemented economically for screening of large numbers of people at sites remote from~     limited and expensive diagnostic instrumentation. Thus there is a possibility that this~     design can be prognosis biomarker as well as a positive/negative indicator.~   "
160347|NCT01467245|"~     This is a pilot randomised controlled trial comparing open versus thoracoscopic surgery for~     repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic~     hernia in neonates. Thoracoscopic surgery involves insufflation of carbon dioxide into the~     thoracic cavity and may therefore cause hypercapnia and acidosis.~   "
160348|NCT01467232|"~     Following myocardial infarct, cellular therapy is a potential approach to repopulate the~     injured myocardium, to treat heart failure and restore cardiac function. The purpose of this~     study is to assess the safety, feasibility and efficacy of intramyocardial delivery of~     selected autologous CD133+ bone marrow stem cells at the time of coronary artery bypass~     grafting in patients with chronic ischemic cardiomyopathy.~   "
160358|NCT01467102|"~     This project a European observational study on the incidence and characteristics of chronic~     post surgical pain (CPSP).~      Research Questions~        -  What is the incidence of chronic post surgical pain (CPSP) in Europe?~        -  What are the risk factors of chronic post surgical pain (CPSP) related to surgery,~          patient and anaesthesia management?~        -  What are the difference in incidence and risk factors in different European countries?~   "
160349|NCT01467219|"~     The surgical management of high-risk endometrial cancer often involves an extensive operation~     to remove lymph nodes as sites of possible cancer spread.~      18F-FDG PET/CT imaging is increasingly being used to identify sites of cancer spread and~     recently groups have used an intra-operative gamma probe to better localize metastatic~     disease. In this pilot study, patients with newly diagnosed early stage, high-risk~     endometrial cancer undergoing primary surgery will have a pre-operative PET scan and~     intra-operative localization of metastatic lymph nodes with the use of a gamma probe. A~     complete lymphadenectomy will follow and ability to detect positive lymph nodes of both PET~     scan and the intra-operative probe will be calculated.~      This study addresses the feasibility of an FDG detection gamma probe in addition to a~     pre-operative PET/CT for lymphatic mapping in women with clinical early stage high risk~     endometrial cancer. The study will also evaluate the role of identifying metastatic lymph~     nodes intraoperatively that would otherwise be clinically negative.~   "
160350|NCT01467206|"~     The LAST study is a Norwegian multi site randomised controlled trial that intends to assess~     the effect of a long term follow up program after stroke. The program consists of a~     coordinating physiotherapist who will encourage and motivate included patients to perform at~     least 60 minutes of intensive motor training every week and 30 minutes of physical activity~     every day for 18 months after inclusion. The primary hypothesis is that patients receiving a~     long term follow up program after stroke will have better motor function at end of follow up~     than patients receiving standard care. A total of 390 home dwelling stroke patients living in~     the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at~     St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will~     be randomised to an intervention group receiving the long term follow up program or to a~     control group receiving standard care. Motor function, mental health and physical functioning~     in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by~     the Norwegian Research Council, the Norwegian University of Science and Technology and the~     Central Norway Regional Health Authority and will conclude at the end of 2015.~   "
160351|NCT01467193|"~     This study aims at assessing the effect of standardized dietary fat load and short-term~     aerobic exercise on systemic lipolysis, flexibility and partitioning of ectopic fat stores~     (intramyocellular = IMCL, intrahepatocellular = IHCL, intramyocardial lipids = IMCaL) in~     relation to FFA in endurance trained athletes and hypopituitary patients compared to~     sedentary healthy control subjects.~      Exercise is a powerful stimulation for growth hormone (GH) secretion in health. A~     standardised exercise test can, therefore, be discriminative for the diagnosis of~     GH-deficiency in adults. This will be assessed.~      Hypothesis (ectopic fat stores)~        1. Ectopic fats stores are flexible fuel stores and are influenced by diet and physical~          activity.FFA availability may play an important regulatory role.~        2. There is a tissue specific partitioning of triglycerides and/or FFA among non-adipose~          organs after fat load and physical exercise~        3. The flexibility of ectopic fat stores is related to insulin sensitivity~        4. Lipolytic and anti-lipolytic hormones are critical for regulating FFA availability (at~          rest or during exercise) and therefore also for the regulation of ectopic fat stores.~        5. GH is a lipolytica hormone. Lack of GH in adulthood is related to decreased FFA~          availability thereby influencing ectopic lipid stores Hypothesis diagnosis of GHD~        6. A short intensive physical exercise shows a good discriminative power to diagnose GHD.~   "
160352|NCT01467180|"~     A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not~     efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off~     dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of~     Rhabdomyolysis patients as by conventional treatment with standard high flux dialyzer.~   "
160353|NCT01467167|"~     Recently, a new software program for anesthesia has been developed, called Smart Pilot View.~     This program monitors the patient, the anesthetic drugs given, and the calculated depth of~     the anesthesia. The purpose of this study is to determine whether the use of this program~     improves the quality of anesthesia.~   "
160354|NCT01467154|"~     The aim of the present study is to determine whether a high dose of intravenous NAC is~     efficient in preventing CN after emergency contrast injection in patients with renal failure.~   "
160355|NCT01467141|"~     This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy~     in children with type 1 diabetes.~   "
160356|NCT01467128|"~     The next four decades will see a marked expansion of the elderly population in Ireland, in~     particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of~     prescription medicines in Ireland and have the highest prevalence rates of major~     polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and~     consequent major morbidity and mortality. Epidemiological data from the Unites States~     indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that~     effective evidence based interventions can be applied to this major public health problem.~      A recently described approach to hospitalised older patients' medication optimisation is that~     of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist with~     expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients~     from admission to discharge. The pharmacist provides a detailed pharmaceutical care plan for~     older patients and their carers where appropriate as well as feedback information to~     prescribers in the event of detecting instances of probable medication inappropriateness.~     Whenever an opportunity for medication optimisation is identified, the pharmacist discusses~     the opportunity with the prescriber who can accept or reject the intervention. At discharge~     from hospital, the pharmacist also provides written and verbal information on treatment~     changes to the patient / caregiver and GP. The intervention therefore represents a~     comprehensive pharmaceutical care approach that is based upon careful review and subsequent~     consensus on individualised pharmacotherapy. In an RCT comparison of this approach with~     standard care, older patients in the intervention arm of the study had significant~     improvements in medication appropriateness (medication appropriateness index (MAI), Beers'~     criteria, and Assessing Care of Vulnerable Elders (ACOVE) criteria.). Expert pharmacist~     review of older peoples' medication in hospital is a proven intervention in term of reducing~     inappropriateness of medication.~   "
160357|NCT01467115|"~     More than 50% of Head and Neck cancers are locally advanced at presentation. Although~     surgery, in combination with other modalities like radiation therapy can achieve 40-50% five~     year survival rates, resection in the head and neck region can leave patients with poor~     functional and cosmetic outcomes.~      Due to these concerns about quality of life after surgery, there has been a lot of interest~     in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy~     and biologics has showed promising results. However, questions still remain about the ideal~     combination treatment regimen.~      Based on assimilation of data from multiple sources, our study tries to identify the role of~     a potentially highly effective multi-modality regimen based on induction chemotherapy~     (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent,~     Cetuximab, and radiation therapy.~   "
160360|NCT01467076|"~     This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in~     Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume~     sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate~     the feasibility and safety of prolonged IPGE1 administration and determination of optimal~     dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over~     a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of~     IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale~     randomized controlled trial will be planned.~   "
160361|NCT01467063|"~     Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile~     (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to~     become less sensitive to insulin, particularly during adolescence.~      The overall objective of this project is to gain further insight into the possible benefits~     of supplementation with glutamine (GLN), a natural dietary amino acid, enhancing insulin~     sensitivity in adolescents with T1D. To elucidate the impact of glutamine, the investigators~     will use a method called the 'euglycemic, hyperinsulinemic clamp': it consists of giving an~     IV drip of insulin, while the drop in blood sugar is prevented by giving variable, precisely~     measured amounts of glucose by vein: the amount of glucose required to prevent a drop in~     blood sugar reflects the body's sensitivity to insulin. The investigators will also give an~     IV drip of glucose and arginine (a building block of protein) 'tagged' with non-radioactive~     isotopes to better understand how glutamine may work. This procedure will be performed in 2~     groups of 10 adolescents in the morning either after a strenuous exercise performed the~     previous afternoon (group 1; n=10), or after a sedentary day (group 2; n=10). Each subject~     will be studied twice, once after taking oral GLN, once after placebo, in separate clinical~     research center (CRC) admissions a few weeks apart, in random order.~      Should the investigators hypothesis prove to be true, it would warrant long term studies to~     determine whether sustained dietary GLN supplementation can decrease insulin requirements and~     ultimately improve diabetes control in teenagers with T1DM, If successful, this approach~     could potentially have a significant positive impact in terms of adolescent health.~   "
160362|NCT01467050|"~     The next four decades will see a marked expansion of the elderly population in Ireland, in~     particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of~     prescription medicines in Ireland and have the highest prevalence rates of major~     polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and~     consequent major morbidity and mortality. Epidemiological data from the United States~     indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that~     effective evidence based interventions can be applied to this major public health problem.~      Recent research data indicate a cause-and-effect relationship between inappropriate~     prescription medicines and serious ADEs in older people in hospital. To date, Beers' criteria~     have been the dominant set of criteria for defining potentially inappropriate medicines~     (PIMs) in late life. Research data collected by this group show that the recently validated~     STOPP/START criteria (Screening Tool of Older Persons' Prescriptions and Screening Tool to~     Alert doctors to Right Treatment) identify ADEs that are causal or contributory to acute~     hospital admission in older people 2.7 times more frequently than Beers' criteria. Based on~     these findings, our hypothesis is that STOPP/START criteria have the potential to be used as~     a regular intervention for the purpose of ADE prevention in older people. A recent single~     centre randomised control trial (RCT) undertaken at Cork University Hospital showed that~     prospective application of STOPP/START criteria led to a highly significant improvement in~     medication appropriateness in older hospitalised patients compared with standard inpatient~     pharmaceutical care. Significantly, the improvement in medication appropriateness was~     maintained to the end of the study follow-up i.e. 6 months post-discharge. However, the~     ability of STOPP/START criteria to significantly reduce ADEs in a prospective RCT has yet to~     be demonstrated.~   "
160363|NCT01467037|"~     Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The~     cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would~     amount to 13,600 Canadian children < 5 years. The incidence of nosocomial RV infections is an~     average of 8/10,000 patient-days in children < 5 years. An immunization program with a~     live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented,~     free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait~     of the disease and give critical information to the public health agencies as they struggle~     to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases~     with similar characteristics; estimate selection bias in passive laboratory-based~     surveillance; and estimate the agreement between surveillance time-series created from~     passive and active surveillance data sources.~   "
160364|NCT01467024|"~     The purpose of this study is:~        1. To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.~        2. To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive~          population.~   "
160365|NCT01467011|"~     The purpose of this study is to gather information regarding the use of Myfortic, Prograf,~     and corticosteroids in new liver transplant recipients. These three medicines help to prevent~     the body from rejecting the transplanted liver. The information the investigators are~     obtaining is data relating to the process of Myfortic absorption by the body, its~     distribution in the body, the breakdown of Myfortic in the body, and its elimination from the~     body. This absorption, distribution, breakdown, and elimination is called pharmacokinetics.~   "
160366|NCT01466998|"~     Hot flashes occur in as many as two thirds of U.S. women during menopause and are severe~     enough to require treatment in 20%. Although postmenopausal hormone therapy is effective in~     suppressing hot flashes, it is associated with increased risk for a variety of serious~     adverse effects. There is an urgent need for alternative treatments that are effective, safe,~     and easy to use. In this study, the investigators will compare two different types of~     behavioral relaxation therapies, paced respiration and music therapy, for treatment of~     menopausal hot flashes. Effects on frequency of hot flashes, other symptom and~     quality-of-life outcomes associated with hot flashes, and physiologic measures of~     sympathetic/parasympathetic activity will be examined.~   "
160367|NCT01466985|"~     This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral~     activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve,~     HIV-1-infected participants.~   "
160368|NCT01466972|"~     The purpose of this study is to evaluate the clinical benefit rate at 12 weeks from the~     addition of pazopanib to a non-steroidal aromatase inhibitor (NSAI) (letrozole or~     anastrozole) in patients with hormone receptor positive advanced breast cancer progressing on~     the same NSAI hormone therapy.~   "
160678|NCT01462890|"~     The purpose of this study is to determine whether the early and continuous addition of~     bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early~     and continuous addition of bevacizumab for up to 15 months.~   "
160369|NCT01466959|"~     An alternative to systemic heparin anticoagulation for HD is citrate dialysate (CD). CD~     contains a small amount of citric acid rather than acetic acid as the acidifying agent. The~     use of citrasate may lead to lower heparin requirements in hemodialysis. This is a~     randomized, double blinded, two-period crossover trial in HD patients to compare the effect~     of citrasate dialysis (CD) and usual acetic-acid based dialysate (AD) on heparin dose.~   "
160370|NCT01466946|"~     The purpose of the study is to understand why Hispanic/Latino patients with lung cancer are~     diagnosed later than other groups.~   "
160371|NCT01466933|"~     Children of mothers in the intervention parenting program are expected to show benefits over~     the standard care control group in terms of better cognitive/language development, less~     recent illness, and better height for age. The mothers assigned to the intervention parenting~     program are expected to evidence higher levels of home stimulation, better health prevention,~     and better dietary diversity, along with more accurate knowledge of child development.~   "
160372|NCT01466920|"~     The goal of this research is to fill the knowledge gap relating to why up to 20 percent of~     total knee arthroplasty (TKA) patients are dissatisfied with their clinical outcomes and to~     answer the research question: What are the drivers of variation in the patient experience~     with primary (ie. not revision) TKA?~   "
160373|NCT01466907|"~     The aim of this study was to examine to what extent a one year population of stroke patients~     at a university hospital had well regulated risk factors and health problems one year after~     stroke, and if a structured nurse-led previous follow-up in the intervention group including~     referrals if needed could influence health outcome and risk factors one year after stroke.~   "
160374|NCT01466894|"~     This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection,~     multiple dose administration study comprising three groups, with up to 40 patients in each~     active treatment and placebo group. Patients with biopsy proven nonalcoholic steatohepatitis~     (NASH) and elevated liver enzymes will be randomized to undergo a liver MRI scan and to~     receive Imm 124-E or placebo for 24 weeks. During this period, patients will be followed for~     clinical and laboratory effects. At the end of 24 weeks of treatment, patients will undergo a~     second liver MRI scan. Patients will be followed for an additional 4 weeks for safety after~     completion of treatment.~   "
160375|NCT01466881|"~     This phase II trial studies how well alisertib works in treating patients with peripheral~     T-cell non-Hodgkin lymphoma that has come back after a period of improvement or has not~     responded to treatment. Alisertib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth.~   "
160376|NCT01466868|"~     The purpose of this study is to evaluate the antitumor efficacy and the safety of MK 2206 in~     patients with relapsed or refractory diffuse large B cell lymphoma.~   "
160377|NCT01466855|"~     This study will test if giving topotecan directly into the blood vessel of the eye will~     improve the treatment of retinoblastoma. This method is referred to as selective~     intra-ophthalmic artery chemotherapy (SIOAC).~      The goals of this study are:~        -  To find out if topotecan is an effective treatment for retinoblastoma when delivered~          directly to the ophthalmic artery (SIOAC delivery)~        -  To find out what kind of effects (good and bad) can be expected when topotecan is given~          by SIOAC~        -  To assess visual pathway function before and after the study therapy~        -  To learn more about the pharmacology (how your body handles the drug) of topotecan when~          delivered directly to the ophthalmic artery~   "
160378|NCT01466842|"~     The purpose of this study is to determine whether catheter ablation is more effective than~     antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the~     patients a subcutaneous loop recorder will be implanted.~   "
160379|NCT01466829|"~     The aims of this study is to compare healing time and quality of newly formed bone in cardiac~     surgery patients treated with PTH post-surgically and a control group treated with saline.~   "
160380|NCT01466816|"~     Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in~     unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle~     towards less accumulation of lipid metabolites and an improved insulin sensitivity.~      Objective:~        1. The contribution of dietary vs endogenous fat sources to lipid overflow in the~          circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant~          subjects vs obese insulin sensitive controls.~        2. The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs~          polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and~          storage, fatty acid mediated gene expression and postprandial insulin sensitivity in~          obese insulin resistant subjects.~      Study design: single-blind randomized cross-over trial~      Study population: obese males (35-70 years) with or without insulin resistance~      Intervention:~        1. 1 test meal~        2. 3 test meals with a different fatty acid composition~      Main study parameters/endpoints:~      More insight whether dietary fat quality may modulate circulating lipids and skeletal muscle~     fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an~     increased insulin sensitivity.~   "
160381|NCT01466803|"~     Variability in drug response can be due to either pharmacokinetic or pharmacodynamic factors.~     The reasons why people differ in pharmacokinetics or pharmacodynamics are manifold and~     include, e.g., genetic factors, diseases, age and concomitantly administered drugs. Oxidation~     reactions are dominant in the metabolism of drugs and cytochrome P-450 enzymes (CYP) have~     been recognized as chief contributors (Guengerich 1992). We have previously shown that drug~     interactions mediated by the inhibition of CYP enzymes may be of major clinical significance~     (Olkkola et al. 1993; Olkkola et al. 1994; Varhe et al. 1994; Olkkola et al. 1999; Palkama et~     al. 1999; Jokinen et al. 2000).~      Buprenorphine undergoes extensive first-pass metabolism and has low oral bioavailability of~     15 % (Cone et al. 1984). Bioavailability following sublingual administration of buprenorphine~     is higher, 50-60 % (Nath et al. 1999). After high sublingual doses of buprenorphine (8-24~     mg), peak plasma concentrations are reached in 1 hour (McAleer et al. 2003, Ciraulo et al.~     2006) and after low sublingual doses (0.4 mg) they are reached in approximately 3 h~     (Billingham 1981). Approximately two-thirds of a buprenorphine dose is excreted unchanged,~     and the rest is metabolized in the liver and intestinal wall. N-dealkylation of buprenorphine~     mainly via CYP3A but also CYP2C8 yields norbuprenorphine, and glucuronidation yields~     buprenorphine-3-glucuronide (Cone et al. 984). Norbuprenorphine is excreted in the urine~     after subsequent conjugation. 80-90 % of buprenorphine is excreted by the biliary system and~     enterohepatic circulation (Brewster et al. 1984)~      Although few interaction studies of high-dose buprenorphine and antiretrovirals have been~     conducted (McCance-Katz EF et al. 2007), the effect of CYP3A inhibitors on the~     pharmacokinetics of low-dose buprenorphine is unknown. Because the use of buprenorphine in~     pain management is increasing after the introduction of transdermal buprenorphin patches to~     the market, it is clinically relevant to study and quantify possible interactions of~     buprenorphine with inhibitors of its CYP3A-mediated metabolism such as voriconazole.~      This study is aimed to examine the possible interactions of oral buprenorphine with~     voriconazole.~      Twelve male or female adult non-smoking subjects aged 18-40 years with body weights within~     ±15% of the ideal weight for height will be recruited for the study. The subjects will be~     submitted to physical examination, determination of previous or present chronic diseases, and~     comprehensive laboratory testing to ascertain that they are in good health. The subjects will~     fill in a modified Finnish version of the Abuse Questions (Michna et al. 2004) to assess~     their vulnerability for opioid abuse. Laboratory screening will include CBC (including~     hemoglobin, hematocrit, differential WBC, platelet count), SGOT, SGPT, alkaline phosphatase,~     BUN and creatinine, and for women a pregnancy test. Urine will be screened for glucose,~     proteins and drugs with addiction potential. Blood pressure in sitting position must be~     within normal limits. Base line ECG must be normal.~      Placebo and voriconazole should always be ingested with food, except the first dose on day 5.~      On day 5, the challenge dose of 0.2 or 3.6. mg of oral buprenorphine (Temgesic,~     Schering-Plough) will be administered at 11.00, i.e. 1 h after the last dose of placebo or~     voriconazole. The dose is 3.6 mg after placebo and 0.2 mg after voriconazole. If necessary,~     naloxone (Naloxone B. Braun, Braun) will be given in sufficient doses to counteract the~     severe adverse effects of buprenorphine. For nausea and vomiting, intravenous tropisetron~     will used, if needed.~      The volunteers will fast at least 8 h before the administration of buprenorphine and they~     will have a standard meal 4 h and 8 h afterwards. Ingestion of alcohol, coffee, tea, cola,~     energydrinks and grapefruit juice is not allowed during the test days, nor is smoking~     permitted.~      The interval between the study phases will be four weeks.~   "
160382|NCT01466790|"~     The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977~     (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1~     hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or~     are HCV treatment-naive (patients who never received treatment for HCV infection).~   "
160383|NCT01466777|"~     The aim of this study is to compare the robotic-assisted laparoscopic surgery to the~     traditional laparoscopic surgery in endometrial cancer patients.~      The study is prospective and the patients are randomised into two groups of 50 patients each.~     Randomisation is done with Minim-programme and patients age and Body mass index are taken~     into account.~      The primary endpoint is the operation time. The number of patients in this study is based on~     the non-inferiority design. Presumption is that the operation time in robotic-assisted~     laparoscopy will be 25% longer.~      Secondary endpoints include:~        1. bleeding~        2. complications~        3. conversions~        4. number of pelvic lymph nodes~   "
160384|NCT01466764|"~     The investigators hypothesize that perioperative administration of anakinra will reduce~     incisional pain by lowering the concentration of inflammatory mediators in surgical wounds.~     This knowledge is important because it suggests a new, previously unexplored pharmacological~     target for the control of postoperative incisional pain.~   "
160385|NCT01466751|"~     The present study will explore the effectiveness of a computer based neurobehavioral~     intervention in alleviating symptoms and improving emotion regulation in psychiatric~     populations. It will increase understanding of psychopathology at a neural-circuit level and~     aid development of new non-pharmacological treatment for emotion regulatory deficits.~   "
160386|NCT01466738|"~     The purpose of this study is to evaluate the safety and clinical characteristics of a~     quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16~     will be subsequently used in viral challenge studies with new compounds that are intended to~     treat respiratory diseases.~   "
160387|NCT01466725|"~     The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects~     with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be~     evaluated.~   "
160388|NCT01466712|"~     Inuvair® is a novel fixed combination product used in the treatment of asthma and under~     clinical development for the treatment of COPD. Thanks to the extrafine particle size, it is~     able to target the whole bronchial tree, including the small airways and hence, is expected~     to act in these airways and it may thus be beneficial in COPD in that sense. In COPD, its~     action on the small airways is not directly demonstrated thus far. By way of contrast, dear~     evidence is present that treatment with bronchodilators alone does not beneficially alter~     small airway function. The study hypothesis states that the effects of inhaled~     corticosteroids or ICS/LABA combinations on small airway is present and can be objectivated.~   "
160389|NCT01466699|"~     The purpose of this study is to investigate whether and what extent blood pressure~     variability is associated with arterial stiffness and carotid atherosclerosis, furthermore to~     compare the difference in the relationship of the types of blood pressure variability with~     arterial stiffness and carotid atherosclerosis.~   "
160390|NCT01466686|"~     To evaluate the safety and effectiveness of low dose rate radiation therapy plus~     temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic~     Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery~     followed by radiation surgical resection followed by adjuvant radiation therapy plus~     temozolomide.~   "
160391|NCT01466673|"~     The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and~     Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment~     of female participants with mild to moderate acne vulgaris (pimples).~   "
160392|NCT01466660|"~     This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in~     first-line treatment setting with patients who are having epidermal growth factor receptor~     mutation positive advanced adenocarcinoma of the lung.~   "
160393|NCT01466647|"~     This is a open single-center, explorative, Phase I pilot dose finding study including~     patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and~     carboplatin.~   "
160394|NCT01466634|"~     Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain.~     Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in~     obstructive coronary artery disease.~   "
160395|NCT01466621|"~     The present proposal is designed to investigate the response to CRT in patients who were~     previously paced from the right ventricle (RV). The negative physiologic and structural~     changes associated with chronic RV pacing are well documented, but patient response following~     upgrade to CRT after chronic RV pacing has not been well characterized in a large cohort.~   "
160396|NCT01466608|"~     The aim of this study is to investigate the pharmacokinetics, lipid lowering effect and~     lipidomic profiles of 8-weeks rosuvastatin treatment by OATP1B1 genotype in hyperlipidemia~     patients.~   "
160397|NCT01466595|"~     This study is being done to see whether rifaximin, an antibiotic that works in the~     intestines, can lower the amount of germs in the intestines of HIV infected persons. It is~     possible that when the amount of these germs is lowered, an HIV-infected person's immune~     system will become less active and will have a better chance of recovering. Also, the study~     will evaluate the safety of using rifaximin in HIV-infected subjects.~   "
160398|NCT01466582|"~     In this prospective cohort study the investigators will assess the prevalence and incidence~     of a broad range of age-related co-morbidities and their (known) risk factor among~     HIV-patients and HIV-negative controls. HIV might cause premature onset or accelerated aging~     and could therefore result in an increase of age-related comorbidities when compared with~     controls.~   "
160399|NCT01466569|"~     The purpose of this study is to determine the safety and tolerability profile including the~     dose limiting toxicity of AbGn-7 in patients with chemo-refractory advanced solid tumor of~     epithelial origin, and of AbGn-7 in combination with FOLFOX7 in patients with~     chemo-naive/chemo-refractory recurrent, locally advanced or metastatic gastric cancer.~   "
160400|NCT01466556|"~     The aim of this study is to determine the prevalence of metabolic syndrome amongst obese~     children in our region with a body mass index (BMI) above the 95th percentile for age and~     sex.~   "
160401|NCT01466543|"~     The purpose of this study is to determine whether Zydena (Udenafil) has effect on cerebral~     blood flow and peripheral blood viscosity in normal and subcortical vascular cognitive~     impairment subjects.~   "
160402|NCT01466530|"~     Misoprostol would reduce the uterine bleeding after caesarean delivery, without harmful~     effects on either mother or baby. The investigators postulated that the use of sublingual~     misoprostol during isoflurane anaesthesia for uncomplicated caesarean delivery would reduce~     maternal haemorrhage, uterine atonic effects, and the need for additional uterotonic agents,~     without harmful effects on either mother or baby. Therefore, the present study was designed~     to evaluate the effects of preoperative sublingual misoprostol on maternal blood loss,~     uterine tone, the need for additional oxytocin and neonatal outcome after elective caesarean~     delivery under isoflurane anaesthesia.~   "
160403|NCT01466517|"~     A PHASE IV, OPEN LABEL, RANDOMIZED, TWO-WAY CROSSOVER, SINGLE DOSE STUDY TO DETERMINE THE~     RELATIVE BIOAVAILABILITY OF IBUPIRAC 40MG/ML (LABORATÓRIOS PFIZER LTDA) ORAL SUSPENSION FORM~     VERSUS ALIVIUM® 50MG/ML (MANTECORP INDÚSTRIA QUÍMICA E FARMACÊUTICA LTDA.) ORAL SUSPENSION~     FORM, UNDER FASTED CONDITIONS IN HEALTHY VOLUNTEERS.~   "
160822|NCT01460979|"~     The purpose of this study is to determine the activity, tolerability and safety of~     Temsirolimus in women with ovarian cancer who progressed during the previous platinum~     chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial~     carcinoma.~   "
160404|NCT01466504|"~     Skin toxicity is a frequently observed side effect in the era of molecularly targeted~     therapies. Skin toxicity following administration of protein kinase inhibitors such as~     sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient,~     resulting in dose reduction and discontinuation of treatment. The mechanisms of skin toxicity~     induced by targeted chemotherapy, such as sorafenib or regorafenib, are poorly understood.~     Further research is warranted to better understand the pathophysiology of drug-related skin~     toxicity in this setting and develop correction strategies. This study tests the hypothesis~     that sorafenib and regorafenib interfere with p63 expression and keratinocyte differentiation~     and skin remodeling.~      Eligible study participants will be evaluated clinically for evidence of skin toxicity during~     their visits to the outpatient Oncology clinics. Study participants will undergo skin~     biopsies before sorafenib or regorafenib treatment is initiated and once rash develops or 12~     weeks into treatment with sorafenib or regorafenib. Skin biopsies will be performed in~     Oncology clinics by the study investigators and clinic support staff.~      Study participants will undergo both skin biopsies regardless of whether they develop a rash.~     In patients who develop a rash the most representative lesion will be biopsied. A normal~     appearing area of skin will be biopsied in participants who do not develop a rash.~   "
160405|NCT01466491|"~     The purpose of this study is to determine the level of pain women experience with a surgical~     abortion and the effect that varying paracervical block techniques might have on that pain.~     These different techniques involve wait time following the injection as well as the number of~     sites injected.~   "
160406|NCT01466478|"~     The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus~     calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus~     calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle, using~     the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.~   "
160407|NCT01466465|"~     Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced~     allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is~     limited by a long treatment time and high non-responder frequency. Based on experimental and~     epidemiological evidences we hypothesize that vitamin D can act as an effective~     immunomodulatory adjuvant to overcome these limitations.~   "
160408|NCT01466452|"~     This study is a randomized open label study that implies the administration of asprin~     according to three different regimens.~      The aims of the study are:~        -  to establish whether coronary artery bypass surgery and / or aortic valve replacement~          surgery with bioprostheses is associated with changes in the rate of platelet~          regeneration that can reduce the effectiveness of aspirin administered at a dose of~          100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2.~        -  to determine whether these patients need a different (shorter) interval of~          administration in order to completely and permanently inhibit the platelet COX-1.~      The endpoints of this study are:~      - To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after~     administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2~     alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets crosslinked at 12~     and 24 hours after administration of aspirin~   "
160409|NCT01466439|"~     The repetitive transcranial magnetic stimulation (rTMS) is a recent technique that has~     demonstrated its efficiency in both depression and schizophrenia. However if its efficiency~     has been recognized by the scientific community and the clinicians, its action on neurons and~     cerebral networks remains debated.~      In the motor regions, the different rTMS studies generally use frequencies of stimulation of~     1 to 40 Hz with differential effects; the low frequencies being associated with an inhibitory~     effect whereas highest frequencies have rather some facilitator effects as attested by the~     motor responses. What is valid for the motor system is not however necessarily applicable to~     other cerebral regions that have different neuronal organizations. If it is easy to observe~     these opposite effects of rTMS on the motor system (presence or absence of movements), these~     potential effects on more integrated cortex involved in high level functions have not been~     proved.~      One of the possibilities to interpret the effects of the rTMS in no-motor cerebral regions~     would be to study the modifications of the EEG before and after rTMS and to see if a~     differential effect of the high and low frequencies of stimulation exists. Up to now, the~     studies having coupled these two techniques have observed modifications of the brain electric~     activity only during some seconds to minutes after rTMS, what appears in contrast with the~     clinical effects observed after a long delay (several days).~      The contribution of our research resides in the use of the paradigm of suppression of P50~     evoked potential component before and after rTMS tested with low and high frequencies of~     stimulation. This paradigm consists in two identical auditory stimuli presented at a very~     short interval (generally 500 milliseconds), the second sound generating a P50 wave of weaker~     amplitude than the first or being completely abolished in healthy subjects. However, this~     effect that has been well studied could result from an inhibitory action due to the gabaergic~     interneurons on the pyramidal neurons of the cortex. Thus, the investigators hypothesize that~     high frequency rTMS would have a facilitator effect on temporal lobe and so would induce no~     suppression of the P50 after-rTMS whereas low frequency rTMS would induce an inhibitory~     effect marked by a greater suppression of the P50.~      Methods: 30 healthy subjects (of which 16 women) will be included after written consent. They~     will receive after randomization 2 sessions of rTMS in cross over at 1Hz and 20Hz at 30 days~     interval. An EEG and a P50 evoked potential will be done before and after rTMS. The site of~     stimulation will be determined by neuronavigation and will correspond to the maximal~     activation cluster generated by a language task during functional magnetic resonance imaging.~     The main judgment criterion is the S2/S1 ratio of the P50. The potential secondary effects~     will be evaluated (UKU adapted). The secondary criteria are the comparisons before and after~     rTMS of EEG spectrums in the alpha, beta and gamma bands.~   "
160410|NCT01466426|"~     This pilot study aims at validating 18F-flourodeoxyglucose positron emission~     tomography/computed tomography (FDG-PET/CT) in the detection and characterization of venous~     thromboembolism (VTE) in the entire human body, especially deep venous thrombosis (DVT) and~     pulmonary embolism (PE). On completion of this study the investigators will hopefully be able~     to demonstrate the importance of functional/molecular imaging technique in managing patients~     with this common and potentially fatal disorder.~   "
160411|NCT01466413|"~     This is an early phase study comparing two fixed dose of the study compound ELAPR and a~     Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of~     the upper arm dermis. All subjects will receive three treatments, 3 weeks apart. Each~     treatment will consist of 16 injections in total, each 10mm apart in a grid formation over a~     3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each~     injection will consist of 20-30ul of product delivered using a 30Gx¼ needle.~   "
160412|NCT01466400|"~     It is hypothesized that there will be no difference in the breath hydrogen excretion between~     the 2 different prebiotic formulas.~   "
160413|NCT01466387|"~     This study compares the safety and immunogenicity profile of several travel vaccines given~     alone or concomitantly with MenACWY-CRM to healthy adults.~   "
160414|NCT01466374|"~     The purpose of this study is to determine whether BMS-936557 is effective for the treatment~     of moderate to severely active Crohn's Disease in patients who have had insufficient response~     and/or intolerance to conventional therapy for Crohn's Disease.~   "
160416|NCT01466348|"~     A reduction in alertness and lower levels of performance are commonly associated with the~     common cold. Paracetamol has been shown to be more effective than placebo in treating~     symptoms associated with upper respiratory tract infection; caffeine has been shown to~     increase levels of alertness and improve performance of people suffering from colds. This~     study will investigate any improvement in alertness and performance based on cognitive~     function and mood assessment in subjects suffering from the common cold, when taking a novel~     paracetamol and caffeine combination verses paracetamol alone.~   "
160417|NCT01466335|"~     Ronacaleret is an orally administered CaSR antagonist which has previously been demonstrated~     to transiently increase PTH in both animals and humans. Additional studies in post-menopausal~     women and patients with distal radial fractures have demonstrated both anabolic and catabolic~     effects on bone biomarkers and scans of bone density. Based on ronacalerets ability to~     interact with the CaSR inducing PTH release and activating endogenous bone metabolism of both~     osteoblasts and osteoclasts, it is our intention to evaluate the impact activation of this~     pathway has on mobilization of Hematopoietic stem cell (HSCs) into the periphery.~      This is an adaptive, phase I, randomized, single centre, double-blind dose finding,~     parallel-group, multi-cohort placebo controlled study of the efficacy and safety of~     ronacaleret in up to 45 healthy human volunteers. Cohorts of eligible subjects will be~     studied for periods up to 28 days. Total daily doses of ronacaleret will range from 100mg, up~     to 400mg and be administered for a maximum of 28days. The first part of this study will~     evaluate several doses and schedules of ronacaleret, run in parallel, with respect to their~     ability to affect mobilization of CD34+ cells into the peripheral circulation. In subsequent~     cohorts of the study we will utilize information obtained from previous cohorts to further~     refine and optimise those dosing paradigms which show efficacy. For the first cohort of study~     participants; the study will commence with 6 days of dosing in an inpatient setting followed~     by 21 days of continued dosing and evaluation as an outpatient, with a series of regularly~     scheduled visits, with the final visit on day 28. The study period will include evaluations~     of pharmacokinetic and pharmacodynamic parameters along with standard laboratory and safety~     evaluations. The second cohort may be treated with ronacaleret for periods ranging from 14 to~     28 days in order to optimise the treatment paradigm with respect to pharmacodynamic efficacy.~     The PK/PD of each group in cohort one will be utilized to make adjustments in the total daily~     dose, dose frequency and or duration of dosing investigated in cohort 2. Decisions will be~     made as to dropping doses based on the PK/PD results and any safety considerations. An~     initial equal randomization amongst groups within the first cohort may be adjusted to allow~     for other randomization strategies as various doses and schedules are assessed.~      The objective of this study is to characterise the dose-response curve for ronacaleret with~     respect to safety and efficacy based on changes in peripheral CD34+ cell counts. Results~     obtained from this study will inform us: of optimized doses, schedules, and durations of~     treatment for future studies. Additional cohorts may be added to further explore the dose~     schedule and duration if required. The exact number of cohorts studied will depend on the~     results obtain from the prior groups and the desire to explore a variety of doses and~     schedules. The aims of the present study (CR9115166) include an assessment of the~     pharmacodynamic effects (mobilization of CD34+ cells), safety, tolerability, and~     pharmacokinetics of ronacaleret in healthy human volunteers.~   "
160418|NCT01466322|"~     GSK2018682 is a potent and selective agonist for the sphingosine-1- phosphate receptor~     subtype 1 (S1P1) with the potential to be an effective treatment for multiple sclerosis (MS).~     The immunomodulatory properties of GSK2018682 are related to functional antagonism of S1P1 on~     lymphocytes, resulting in sequestration of lymphocytes within the lymphoid organs, rendering~     them incapable of migrating to sites of inflammation and leading to lymphopenia. Orally~     administered GSK2018682 is very effective in murine experimental autoimmune encephalomyelitis~     (EAE), an animal model of human MS. This study will assess the relative bioavailability of~     different oral formulations of GSK2018682 in healthy volunteers. A tablet formulation is~     desired for progression into future clinical safety and efficacy studies as the current~     capsule formulation is not suited to large scale manufacture. The information obtained in~     this study will help to establish the optimal dosing form for future studies, and also~     determine the effect of food on the pharmacokinetics of GSK2018682.~   "
160419|NCT01466309|"~     Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been~     reported its safety and efficacy in Caucasians at least in the short-term. However, there has~     been no reports in Thai patients. The objectives of this study is to investigate its efficacy~     and safety in Thai patients with OSA.~   "
160420|NCT01466296|"~     The overall objective is to improve the functional status of Middle East adolescents with~     disabilities due to cerebral palsy (CP) and disabilities in adults due to cerebro-vascular~     stroke (Hemiplegia) by a collaborative Jordanian-Israeli-Palestinian-Moroccan applied~     research project.~   "
160421|NCT01466283|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in patients with rhabdomyosarcoma.~   "
160422|NCT01466270|"~     RATIONALE: Donepezil hydrochloride may help lessen cognitive dysfunction caused by~     chemotherapy.~      PURPOSE: This phase II trial is studying donepezil hydrochloride in treating cognitive~     dysfunction after chemotherapy in female breast cancer survivors.~   "
160423|NCT01466257|"~     RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will~     respond to treatment.~      PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.~   "
160424|NCT01466244|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent~     head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.~   "
160425|NCT01466231|"~     Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered~     to the patient until progression, unacceptable toxicity, complete response or inability of~     the subject to comply with study requirements. Feasibility of surgical resection will be~     assessed after every 2 cycles of the treatment in patients with partial response.~   "
160426|NCT01466218|"~     This project will evaluate the effects of World Trade Center (WTC) exposure in WTC responders~     10-13 years following the events of 9/11. Prior studies have described persistent pulmonary~     function abnormalities in a significant portion of responders. The investigators study seeks~     to examine the relationship between pulmonary function abnormalities and other markers of~     chronic cardiopulmonary disease and further elucidate the pathophysiologic effects of~     exposure to inhaled particulate matter (PM) on 9/11. This study will provide critical~     information regarding risk of exposure to PM, risk factors for disease and potential for~     improvements in diagnosis and treatment.~   "
160445|NCT01465971|"~     One of the major challenges in adapting to high altitudes is that with increasing altitude~     sleeping quality declines rapidly. Thus, the night sleep can only provide limited to none~     regeneration. It usually takes a prolonged stay at a constant altitude to adapt sufficiently~     to the altitude and to have a refreshing night sleep. 1975 Reit et. al showed in their~     EEG-recordings that the sleep architecture (the regular succession of the particular sleep~     phases) is disturbed by repeating arousals which occur due to an irregularity in the~     breathing rhythm.~      The purpose of this study is to create a better understanding of the underlying mechanisms~     that lead to failed acclimatization and AMS, due to sleep disturbance.~   "
160427|NCT01466205|"~     Currently, no study to date has directly tested a selective D1R agonist in relation to the~     cognitive impairment of Schizophrenia without the confound of neuroleptics. The investigators~     propose to examine the efficacy of DAR-0100A, a highly selective, full D1R agonist supported~     by pre-clinical and preliminary pilot clinical data, in ameliorating the cognitive deficits~     in Schizotypal Personality Disordered subjects receiving no medications including~     antipsychotics.~      The investigators hypothesize that 1) Baseline primary outcome measures will be impaired in~     Schizotypal personality disorder (SPD) subjects compared to controls, 2) SPD subjects on~     DAR-0100A will show improvement on primary measures greater than healthy controls and SPD~     patients randomized to placebo, and 3) SPD patients will show significant improvements on~     primary outcome variables on drug compared to placebo.~   "
160428|NCT01466192|"~     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and~     Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous~     treatment.~   "
160429|NCT01466179|"~     The purpose of this study is to confirm whether the bispecific T cell engager antibody~     blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or~     refractory Acute Lymphoblastic Leukemia (ALL).~   "
160430|NCT01466166|"~     The primary purpose of this study is to observe patients being treated with KRYSTEXXA in a~     standard healthcare setting in order to evaluate the frequency and severity of infusion~     reactions, anaphylaxis and immune complex related events. Additionally, serious adverse~     events associated with KRYSTEXXA therapy will be identified.~   "
160431|NCT01466153|"~     The overall purpose of the study was to determine if MEDI-551, when used in combination with~     salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are~     not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to~     rituximab in the same population.~   "
160432|NCT01466140|"~     The primary objective of this study is to determine whether exploring the request for help~     more thoroughly improves patient satisfaction in general practice (primary care).~   "
160433|NCT01466127|"~     The purpose of the study is to learn how differences in learning under mildly-stressful~     circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the~     body. The investigators will also examine the impact of any anxiety, depression, and stress~     related symptoms on learning processes.~   "
160434|NCT01466114|"~     Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with~     cognition. Currently, there are no FDA-approved treatments targeting cognitive function in~     Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used~     in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as~     compared to treatment with a placebo pill in combination with standard anti-inflammatory~     drugs in women with MS.~   "
160435|NCT01466101|"~     Pregabalin will decrease the total amount of opioid required in patients undergoing total~     abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related~     side effects in patients undergoing total abdominal hysterectomy.~   "
160436|NCT01466088|"~     Alzheimer's disease is the most common form of dementia and is the fourth leading cause of~     death among people 65 years of age and older. The global prevalence of the disease will~     increase significantly as the population ages, unless preventative treatments can be~     identified and marketed. The present study seeks to evaluate AZD3480 (TC-1734) compared to an~     approved medication (donepezil) shown to improve cognition and function in patients with~     Alzheimer's disease.~   "
160437|NCT01466075|"~     The purpose of this study is to demonstrate that untrained subjects who have diabetes or~     pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and~     obtain valid glucose results.~   "
160438|NCT01466062|"~     To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24~     months or less with immunocompromised medical conditions.~   "
160439|NCT01466049|"~     The purpose of this study is to evaluate new biomarkers for patients presenting to a~     physician for surgery to remove a mass in their pelvis and to continue to evaluate these~     types of patients using the ROMA algorithm for post-market benefits.~   "
160440|NCT01466036|"~     Cabozantinib works by blocking the growth of new blood vessels that feed a tumor. In addition~     to blocking the formation of new blood cells in tumors, cabozantinib also blocks pathways~     that may be responsible for allowing cancers cells to become resistant to other~     anti-angiogenic drugs. Cabozantinib has been studied or is being study in research studies~     as a possible treatment for various types of cancer, including prostate cancer, brain cancer,~     thyroid cancer, lung cancer, and kidney cancer.~      In this research study, the investigators wish to learn if cabozantinib is effective in~     treating patients with pancreatic neuroendocrine and carcinoid tumors.~   "
160441|NCT01466023|"~     Transient hypothyroxinemia of prematurity (THOP) is a typical entity of the preterm infant,~     affecting the majority of preterm infants, born less than 30 weeks of gestational age. It is~     defined as a temporary postnatal reduction from cord values in serum levels of T4 and FT4,~     but with normal thyroid-stimulating hormone (TSH) levels.The etiology of THOP is complex and~     multifactorial. Loss of maternal T4, limited postnatal thermogenesis, hypothalamic-pituitary~     immaturity, limited thyroid gland reserve, persistent fetal thyroid hormone metabolism and~     predisposition to nonthyroidal illness syndrome are several factors that contribute in less~     or more intensity to THOP.The association between THOP and poor neurodevelopmental outcome is~     well established and several therapeutic clinical trials have been set up. However, there is~     currently no evidence for prophylactic or therapeutic supplementation with thyroxine (T4) for~     premature infants with THOP. One study of van Wassenaer et al. showed a beneficial effect of~     treatment of THOP in a subgroup of preterm infants with gestational age less than 28 weeks,~     but a reverse effect in the group with a gestational age of 29 weeks. This is an illustration~     of the limited comprehension of the pathophysiology of THOP.~      Although studies about THOP usually involves the preterm infants born at 33 weeks or earlier,~     one study of Paul et al. showed a decreased thyroid function in late preterm and term infants~     with respiratory distress syndrome as function of severity of illness. Unpublished data of~     our center showed also the presence of THOP, although less frequent, in the group of late~     preterm infants. Other data about this group of preterm infants are scarce.~      During the first half of pregnancy, the fetus is completely dependent of maternal thyroid~     hormone supply and the fetal thyroid gland starts thyroid hormone secretion from about 17-19~     weeks of gestational age. Conditions of maternal (sub)clinical hypothyroidism are associated~     with complications like hypertension, preterm birth, low birth weight, placental abruption,~     and fetal death. One can wonder if there are compensating mechanisms in the placenta,~     providing the fetus with sufficient thyroid hormone in cases of compromised thyroid supply.~     One study showed that total placenta deiodinase type 3 (D3) activity in pregnancies with~     severely hypothyroid fetuses was not significantly lower than in euthyroid controls. Two~     studies showed increased monocarboxylate transporter 8 (MCT8) and decreased MCT10 expression~     within placentae of pregnancies complicated by IUGR. As far as we know, nothing is known~     about possible compensating effects in placentae of mothers with subclinical hypothyroidism~     and the possible influence on the development of THOP.~      Maternal subclinical hypothyroidism during pregnancy is a predisposition for the development~     of overt hypothyroidism. The influence of maternal thyroid antibodies during pregnancy~     towards thyroid hormone function of the fetus and consequently neurodevelopmental outcome is~     still not clear. One single study of Negro et al. showed that euthyroid pregnant women who~     are positive for thyroid peroxidase antibodies (TPOAb) develop impaired thyroid function,~     which is associated with an increased risk of miscarriage and premature deliveries. They also~     showed that substitutive treatment with levothyroxine (LT4) is able to lower the chance of~     miscarriage and premature delivery.A study of Pop et al. concluded that children of pregnant~     women who had elevated titers of TPO-Ab but normal thyroid function are at risk for impaired~     development.Nothing is known about the possible influence of maternal thyroid antibodies~     towards the development of THOP, although a theoretical link is possible.~      The investigators want to investigate whether there are compensatory mechanisms in placentas~     of premature born infants and whether the maternal thyroid hormone condition is a prediction~     of the development of THOP in the premature infant. The investigators want to investigate the~     differences between several groups of preterm infants: 24-28 weeks, 28-32 weeks and 32-36~     weeks. The further aim of this study is to investigate the impact of maternal thyroid hormone~     condition during pregnancy on neurodevelopmental outcome of the neonate.~      In Belgium, 8% of the newborns are born preterm. There are about 2000 deliveries each year in~     the University Hospitals Leuven. Between 2 and 5% of all pregnant women are considered to~     have subclinical hypothyroidism and preterm birth is almost 2-fold higher in women with~     subclinical hypothyroidism.The incidence of THOP is 30 %. We performed a statistical power~     calculation with a confidence level of 95%. Given the above data and with the assumption that~     50% of the premature babies born to a hypothyroid mothers will develop THOP, we need to~     include 320 patients who give premature birth to obtain a statistical power of 80%.~     Therefore, the inclusion time will be 2 years.~   "
160442|NCT01466010|"~     Purpose of the study:~      To retrospectively determine the clinical results in an unselected group of consecutive~     patients with osteoid osteoma treated by surgery.~      Materials and Methods:~      In 150 consecutive patients with clinical and/or radiological evidence for osteoid osteoma at~     any location, the clinical symptoms and imaging findings (radiographs and computed tomography~     (CT)) were assessed before and after surgery. There were no exclusion criteria for this~     study. A good response was defined as disappearance of symptoms that were manifested at~     presentation and were attributed to osteoid osteoma. Clinical assessment after the procedure~     was performed prior to discharge; within 2 weeks after the procedure; and at 3, 6, and 12~     months follow-up. After 24 months, a postal questionnaire was used for assessment.~     Radiographic evaluation (radiographs and thin-slice CT) was performed routinely~     pre-operatively and one year after surgery.~      In case of persisting or recurring symptoms the follow-up protocol was again performed~     according to the initial protocol.~      All patients gave their informed consent both for the surgical intervention as for the use of~     their patient data in this retrospective study.~   "
160443|NCT01465997|"~     Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as~     monotherapy in newly or recently newly diagnosed subjects with primary safety variables~     including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs,~     reporting of Serious AEs (SAEs).~   "
160444|NCT01465984|"~     The purpose of this study is to determine whether Iv paracetamol is as effective as Iv~     Morphine sulfate on control of the acute pain in Patient with limb trauma.~   "
160447|NCT01465945|"~     Transanal Endoscopic Microsurgery (TEM) is a minimally invasive technique used to remove~     rectal tumours. After the tumour has been removed from the rectum, the surgeon has a choice~     to close the defect or leave the defect open and naturally close. Currently, both options are~     accepted as standard care.~      Leaving the defect open to close naturally has some possible advantages, including shortened~     operation time and similar rates of postoperative complications. However, there is some~     concern that not surgically closing the defect may lead to more postoperative pain and delay~     in recovery.~      The study will be a double blind randomized controlled trial and determine whether patients~     who have rectal wall defect sutured closed have less post-operative pain compared to patients~     whose defect is left open.~   "
160448|NCT01465932|"~     The program of stretching, strengthening and proprioception is more effective than stretching~     and strengthening program in nursing, with rotator cuff disorder, according to indicators of~     quality of life and job satisfaction.~   "
160449|NCT01465919|"~     The purpose of this study is to evaluate the anti-depressive efficacy of mirtazapine in~     depression induced by peginterferon alpha-2a and ribavirin treatment in Korean patients with~     chronic hepatitis C.~   "
160450|NCT01465906|"~     Phrase: IV~      Indication: dyspnea symptom of chronic obstructive pulmonary disease (COPD)~      Objective: to evaluate efficacy and safety of tulobuterol patch combined with Tiotropium~     bromide for relieving dyspnea symptom of COPD~      Design: a multi-centre randomized parallel blank control study~      Case number: test group 80, control group 80, totally 160~      Site number:7~      Study period: 2010.9 - 2011.8~   "
160451|NCT01465893|"~     This study examines the effect of vitamin D on Retinal changes in patient with optic~     Neuritis.~   "
160452|NCT01465880|"~     The purpose of this study is to develop a fit-for-purpose biochemical verification tool that~     can be used to detect concomitant use of a few (less than 5) conventional cigarettes.~   "
160453|NCT01465867|"~     Serum levels of isolated anti-thyroperoxidase (TPOab) and anti-thyreoglobulin (Tgab)~     autoantibodies are strongly associated with an increased risk of miscarriage and premature~     deliveries in euthyroid pregnant women. Replacement of thyroxine (LT4) or other~     supplementations in euthyroid-Ab positivity during pregnancy has not been established. The~     development of a safe and effective intervention that modulates inappropriate inflammatory~     responses could be a very important component of prevention against adverse health outcomes~     during pregnancy.~      The anti-oxidant Selenium (Se) suppresses autoimmune destruction of thyrocytes and at daily~     dose of 200 mcg and 100 mcg decreases titers of serum TPOAb and TgAb also in Se-non-deficient~     patients with autoimmune thyroiditis (AIT).~      The use of Se in AIT has been shown to reduce the incidence of postpartum thyroiditis and~     hypothyroidism.~      Women with recurrent pregnancy loss had lower Se levels and Se deficiency has been implicated~     in the pathogenesis of AIT and in the impairment of T/B cell-mediated immunity.~      The purpose of the present study is performed to establish the effect of Se supplementation~     in euthyroid women with AIT (pregnant and in whom embryo transfer is expected within 60 days)~     on Ab trend, thyroid function and structure, implantation rates, pregnancy rates, pregnancy~     outcome and number of obstetrical, fetal and neonatal complications.~   "
160454|NCT01465854|"~     Lung cancer in non-smokers (LCINS) is an increasing public health problem. The BioCAST~     (IFCT-1002) study, promoted by Intergroupe Francophone de Cancérologie Thoracique (IFCT),~     focuses on this entity. It is a national, multicentric, prospective epidemiological study.~     Main objective is to describe the clinical and molecular epidemiology of LCINS in a large~     French cohort composed by cases newly diagnosed in participating centres (around to 1000~     patients expected). The clinical component of the study is based on collecting data directly~     from the patient through a standardized questionnaire during a telephone interview with a~     health professional. The biologic component includes a blood sample collection. A large~     genomic-wide association study and an epigenetic study are also planned. BioCAST hopes to~     provide concrete answers to clinicians and patients questions about this new and frequent~     entity.~   "
160455|NCT01465841|"~     This is a prospective, multi-center study of patients with intracranial or peripheral~     aneurysms who are treated by the PC 400 System. The primary objective is to gather post~     market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial~     and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral~     aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each~     patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long~     term follow-up to one year will be conducted in accordance to the standard of care at each~     participating hospital.~   "
160456|NCT01465828|"~     Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in~     patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention~     (PCI) with drug eluting stent(s. Interindividual variability in platelet response to~     clopidogrel has been reported, with several mechanisms being implicated for high~     post-clopidogrel treatment PR. High on-treatment platelet reactivity (HTPR) is associated~     with an increased risk of adverse events after PCI. Studies in patients on chronic~     clopidogrel treatment are scarce, mainly in diabetic patients where HTPR is frequently~     present and independently predictive of adverse events. Optimization of platelet inhibition~     in patients with HTPR by increasing clopidogrel or alternatively, by more potent P2Y12~     inhibitors is a controversial issue, mostly studied in post PCI patients, while no data~     exist, to the best of the investigators knowledge, in stable patients on chronic clopidogrel~     treatment. Therefore all HTPR patients, that will accept to participate, will be enrolled~     will randomize (Day 0) in a 1:1 ratio to either clopidogrel 150 mg a day, or prasugrel 10 mg~     a day, until Day 14 post randomization. A 14 ± 2 day visit will be performed for PR~     measurement and safety evaluation, with the blood sample being will be obtained 16-18 hours~     after the last study-drug dose, will follow by crossover directly to the alternate therapy~     for an additional 14 days without an intervening washout period. At Day 28 ± 2 patients will~     return for the clinical and laboratory assessment as did on Day 14 visit.~   "
160467|NCT01465685|"~     This study compares the interactive emotional/subjective effects of single doses of~     3,4-methylenedioxymethamphetamine (MDMA, ecstasy) and methylphenidate, a dopamine (DA) and~     norepinephrine (NE) transporter blocker, in healthy subjects. The primary goal is to~     determine the role of transporter mediated DA and NE release in the subjective response to~     MDMA in humans. The investigators hypothesize that methylphenidate will attenuate the~     subjective response to MDMA.~   "
160457|NCT01465815|"~     This phase I/II trial studies the side effects and best dose of linsitinib when given~     together with erlotinib hydrochloride and radiation therapy after surgery in treating~     patients with advanced or recurrent head and neck cancer. Erlotinib hydrochloride and~     linsitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy together with erlotinib hydrochloride and linsitinib may kill more tumor cells.~     Giving these treatments after surgery may kill any tumor cells that remain after surgery.~   "
160458|NCT01465802|"~     To assess the impact of prophylactic treatment on the incidence of adverse events in advanced~     NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To~     assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence~     of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1~     mutation, HER-2 mutation or HER-2 amplification).~   "
160459|NCT01465789|"~     The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic~     risk in children. The study hypothesis is that a combination of salivary biomarkers will~     predict the presence of risk factors including impaired fasting glucose, hypertension and~     dyslipidemia and will reflect changes in these risk factors over time.~   "
160460|NCT01465776|"~     This pilot phase I trial studies freeze-dried black raspberries in treating patients with~     oral squamous cell cancer undergoing surgery. Chemoprevention is the use of certain drugs to~     keep cancer from forming. Eating freeze-dried black raspberries may help prevent or treat~     oral cancer~   "
160461|NCT01465763|"~     This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in~     patients with moderate to severe ulcerative colitis who have failed or be intolerant to one~     of following treatments for ulcerative colitis: oral steroids,~     azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.~   "
160462|NCT01465750|"~     Cancer is the leading cause of mortality in the investigators country. According to the~     statistics of the Department of Health, the incidence of ovarian cancer increased in recent~     years and the mortality rate is highest in all gynecologic malignancies in Taiwan. Ovarian~     cancer becomes a more and more important disease gradually in the field of gynecologic~     malignancies. The classification of histology in ovarian cancer included epithelial ovarian~     cancer、germ cell tumors、sex-cord cell tumors…etc. Epithelial ovarian carcinoma is the most~     common ovarian cancer clinically. Early diagnosis is difficult due to the lack of obvious~     initial symptoms, so ovarian cancer patients are usually at advanced stage when the diagnosis~     is confirmed. The prognostic parameters for ovarian carcinomas include tumor stage,~     histological subtype, degree of malignancy, residual tumor after surgical intervention and~     the response to chemotherapy. However, the possible etiology and mechanism of ovarian cancer~     is still unclear. However, there is no epidemiologic data of ovarian cancer in Taiwan.~     Therefore the investigators propose this study to use Taiwan registry database provided by~     Department of Health to analyze the epidemiology and prognosis of ovarian cancer patients in~     Taiwan.~   "
160463|NCT01465737|"~     Endometrial cancer is the second most common gynecologic cancer in Taiwan. Two types of~     endometrial cancer may be distinguished by standard clinicopathologic criteria; type I tumors~     are of low grade, endometrioid histology, estrogen related, and have a good prognosis,~     whereas type II tumors are high grade, of non-endometrioid histologies, unrelated to~     estrogen, and have a poor prognosis. Several clinicopathological parameters were reported to~     correlate with prognosis of endometrial cancer including tumor FIGO stage, cell type,~     cytological grading, depth of myometrial invasion, tumor size, lymph node status, and etc.~     However, there is no epidemiologic data of endometrial cancer in Taiwan. So the investigators~     propose this study to use Taiwan registry database provided by Department of Health to~     analyze the epidemiology and prognosis of uterine cancer patients in Taiwan.~   "
160464|NCT01465724|"~     The current prevalence of hypertension as part of the metabolic syndrome is substantial and~     is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous~     system (SNS) activity has been identified as a common and key factor in disease states as~     obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to~     the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation~     (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central~     nervous system, has been shown to be an effective means of modulating elevated SNS activity.~      This current study is an observational feasibility study, with the aim to investigate the~     effect of renal denervation on changes in insulin resistance and blood pressure in patients~     with obesity related hypertension. The investigators will study different variables: a~     laboratorial set, a set of blood pressure measurements and a set of investigations in the~     vascular laboratory.~      Hypothesis~        -  The investigators hypothesize that renal denervation has a beneficial effect on insulin~          resistance.~        -  The investigators hypothesize that there will be no complications related to the device~          or procedure.~   "
160465|NCT01465711|"~     The purpose of this study is to determine the diagnostic accuracy of Pancreatic Stone Protein~     (PSP) in predicting patient outcomes with suspected peritonitis in the Intensive Care Unit~     after abdominal surgery and compare PPS with other blood parameters, including C-Reactive~     Protein (CRP), White Cell Count (WCC), Interleucin-6 (IL-6) and Procalcitonin (PCT).~   "
160466|NCT01465698|"~     NURSE-RCT is a randomized controlled trial which aims at prevention of evolution of chronic~     low back pain (LBP) and related disability in female nurses.~      The study investigates the effectiveness and financial feasibility of six months~     neuromuscular training and counselling, and their combination on LBP, movement dysfunction~     and fear-avoidance behaviour.~      The target for neuromuscular training is to reduce movement dysfunction and motor control~     impairments, caused by trauma and subfailure injuries of spinal ligaments. Training aims at~     enhancement of motor control of lumbar neutral zone in different positions and movements,~     balance, coordination, trunk muscle endurance and leg strength.~      The target for counselling is change in attitudes and behaviour, which help to reduce the~     fear of pain and encourage to physical activity and other physical tasks.~      The hypothesis is that together neuromuscular exercise and counselling have a stronger~     influence on LBP, movement dysfunction and fear-avoidance behaviour than either used alone.~      Assessments of effectiveness will be conducted after six, 12, and 24 months of the beginning~     of interventions.~   "
160468|NCT01465672|"~     Water imbalance and consecutive electrolyte disturbances are common in the postoperative~     course of neurosurgical patients after pituitary surgery. Diabetes insipidus (DI) may~     complicate the postoperative course in as many as 30% of patients. Early and accurate~     diagnosis of water and electrolyte disturbances postoperatively is important for an adequate~     fluid and drug administration. However, identifying the causes is challenging/ ambiguous in~     clinical practice. Levels of antidiuretic hormone (ADH) might contribute to a straightforward~     diagnosis, though, its measurement is cumbersome. ADH is derived from a larger precursor~     peptide along with copeptin, which is a more stable peptide directly mirroring the production~     of ADH. Copeptin can be assayed readily in plasma. Aim: To investigate whether copeptin can~     accurately diagnose postoperative disturbances of water homeostasis (i.e. Diabetes insipidus~     and SIADH) in a cohort of patients undergoing intracranial tumor surgery.~   "
160469|NCT01465659|"~     This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib~     hydrochloride when given together and to see how well they work in treating patients with~     advanced pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery. Drugs~     used in chemotherapy, such as temozolomide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     tumor growth. Giving temozolomide together with pazopanib hydrochloride may be an effective~     treatment for patients with PNET.~   "
160470|NCT01465646|"~     The purpose of this study is to measure the area under the curve (AUC0-48h; extent of~     systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine~     (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as~     tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered~     as a reference solution without iodine.~   "
160471|NCT01465633|"~     The purpose of this study is to measure the area under the curve (AUC0-48h; extent of~     systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine~     (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as~     tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered~     as a reference solution without iodine.~   "
160472|NCT01465620|"~     Metabolic disorders such as diabetes mellitus, glucose intolerance and possibly metabolic~     syndrome can induce a peripheral neuropathy. To investigate the effect of physical training~     and diet education on neuropathic symptoms and neurophysiological parameters of patients with~     metabolic neuropathies.~   "
160473|NCT01465607|"~     This project seeks to determine the personal and organizational conditions that are most~     conducive to the widespread adoption by community-based organizations (CBOs) of effective~     programs for reducing the spread of HIV and other sexually transmitted infections (STIs).~     Taking a brief, single-session counseling program (called Mujer Segura) that has been~     proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities~     along the U.S. border, this project will study the implementation of the program in CBOs in~     12 additional cities throughout Mexico to determine how best to ensure that the program~     remains true to the original model and retains its effectiveness. Mexico has been chosen~     because HIV is a global problem that respects no international borders, and because HIV~     prevention programs that can be implemented in settings with limited resources are urgently~     needed in many parts of the world.~   "
160474|NCT01465594|"~     The study aims to show the technical feasibility of the suprapubic urinary diversion after~     endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the~     patients with at least the same catheter complication rate in comparison to the urethral~     urinary diversion.~   "
160475|NCT01465581|"~     The target population of this study is children with primary or secondary daytime urinary~     incontinence, who have failed to improve adequately despite compliance with at least 6 months~     of standard medical therapy.~      The study hypothesis is that patients who under go cutting the filum terminale - the~     string-like lower end of the spinal cord - will have improved bladder function at 6-month~     follow up.~      Bladder function and its effects on quality of life will be measured before surgery and at~     6-month follow up.~   "
160476|NCT01465568|"~     The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment~     of osteoporosis in patients using bisphosphonates.~   "
160477|NCT01465555|"~     The specific aims of the project are to conduct a three-phase study to develop a data-driven~     Clinical Alert feature to the RecoveryTrack™ Concurrent Recovery Monitoring (CRM) system and~     test its efficacy, as follows:~      Phase I - Analyze RecoveryTrack and outcomes data to create a clinical algorithm that~     predicts early treatment attrition; adapt elements of a cognitive behavioral intervention~     (CBI) for use in addressing Clinical Alerts, as well as adapting training and adherence~     measures; reprogram RecoveryTrack with a Clinical Alert feature for each of the first three~     monitoring assessments to inform counselors when a client is at High Risk to leave treatment.~      Phase II -Conduct a feasibility trial to refine Clinical Alerts + CBI intervention and the~     study measures/procedures.~      Phase III - Conduct a pilot randomized clinical trial comparing outcomes of clients whose~     counselors were randomized to Clinical Alerts + CBI to those of clients whose counselors were~     assigned to TAU (control condition). The primary hypothesis is that clients who evidence a~     High Risk for attrition will have longer lengths of stay in the Clinical Alerts + CBI~     condition than High Risk clients in the control condition. Secondary client hypotheses are~     that High Risk clients in the Clinical Alert + CBI condition will attend more treatment~     sessions, have more drug-free urine results, and receive more ancillary services than High~     Risk clients in the control condition.~   "
160478|NCT01465542|"~     Retrospective chart review of patients who receive N-acetylcysteine for Acetaminophen(APAP)~     toxicity to assess length of oral vs. IV treatment and the effect of a Clinical Pharmacology~     and Toxicology division in the management of APAP ingestions.~   "
160479|NCT01465529|"~     The purpose of this study is to determine the safety and local tolerability of multiple dose~     administration of inhaled OligoG in CF subjects. Particular emphasis will be put on local,~     clinical tolerance, pulmonary function and pulmonary adverse events. The secondary purpose is~     to monitor the effect of multiple dose administration of inhaled OligoG on various efficacy~     variables, such as mucolytic activity, lung function, respiratory symptoms, Quality-of-Life~     and microbiological outcome measures.~   "
160480|NCT01465516|"~     Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics~     compared to historical control. There is no difference in SVR between patients with an~     undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks~     of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable HCV~     RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based therapy~     and 12 weeks of PR.~   "
160481|NCT01465503|"~     Bleeding occurring during percutaneous coronary interventions (PCI has now emerged as one of~     the most common complication of PCI and adversely affect in-hospital, short- and long-term~     outcome.As bivalirudin proved its effectiveness in decreasing haemorrhagic events during PCI,~     its administration may be advocated in subjects deemed at high risk of bleeding.Objective of~     the present trial is to compare the safety and effectiveness of procedural use of bivalirudin~     in comparison to unfractionated heparin (UFH) in patients undergoing PCI deemed at high risk~     of procedural bleeding.~   "
160482|NCT01465490|"~     This is a three-staged study to develop and evaluate a monitoring instrument and associated~     intervention, as follows:~      Stage 1 - Develop and determine the reliability, validity, and sensitivity to change of a~     brief Multidimensional Monitoring Instrument (MMI) for clients in outpatient substance abuse~     treatment (SAT).~      Stage 2 - Develop a Monitoring and Feedback Intervention (MFI) that uses the MMI. As part of~     this process, create a manual, training materials, and competence and adherence measures, and~     conduct a feasibility study within an outpatient SAT unit to refine the intervention and~     associated materials and measures.~      Stage 3 - Conduct a randomized clinical trial (RCT) to determine the preliminary efficacy of~     the MFI compared to treatment as usual (TAU) for clients in outpatient SAT. In this pilot~     study, it is hypothesized that the MFI will positively impact the treatment process, and~     short-term, during treatment, outcomes.~   "
160483|NCT01465477|"~     Fibromyalgia is a clinical syndrome characterized by the presence of chronic widespread pain~     accompanied by tenderness and fatigue. Central sensitization is considered to be a major~     pathogenetic feature of fibromyalgia. While the etiology of fibromyalgia is incompletely~     understood, it is generally considered to result from the interaction between an appropriate~     genetic background and the exposure of a susceptible individual to various inciting~     triggers. These have included among others physical trauma, infection, stress etc.~      The possible role of vaccination in causing or exacerbating fibromyalgia has been previously~     raised. Thus, gulf war syndrome, an entity with considerable clinical overlap with~     fibromyalgia, has been considered to have a possible link with the exposure to multiple~     vaccinations. More recently a theory has been advanced regarding the possibility that~     vaccination - related adjuvants may induce a multisystem disorder characterized by symptoms~     such as fatigue, cognitive impairment and arthralgia (the so called ASIA syndrome).~      The investigators have previously established the safety and efficacy of influenza~     vaccination in Rheumatoid arthritis patients.~      In view of this background it is of considerable clinical importance to ascertain both the~     efficacy and safety of vaccination in patients suffering from fibromyalgia.~   "
160484|NCT01465464|"~     The purpose of this study is to compare the overall survival (OS) for Orantinib in~     combination with transcatheter arterial chemoembolization (TACE) versus placebo in~     combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).~   "
160485|NCT01465451|"~     The purpose of this study is to investigate efficacy and safety of intra-operative~     chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The~     hypothesis is intra-operative intervention might be the best timing for cancer cells killing~     by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor~     debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for~     intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU~     injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into~     portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction,~     and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The~     controlled arm receive curative resection only. All the other treatments will stick to the~     guidelines.~   "
160486|NCT01465438|"~     Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a~     estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a~     progressive, erosive arthritis causing severe disability and increased mortality.~      The biologic treatment infliximab and etanercept have recently been introduced for treatment~     of PsA and psoriasis, and current data indicate a higher efficacy than with previously~     available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but~     preliminary data are encouraging. The improved treatment options have increased the need for~     sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient~     therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography~     (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not~     yet sufficiently studied, methods for this.~      The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel~     imaging- and biomarkers can provide additional information, compared to clinical measures and~     radiography, concerning activity, destructive progression and prediction of therapeutic~     response in PsA patients receiving adalimumab. The perspective is a potential improvement in~     diagnosis, monitoring and prognostication of patients with PsA.~   "
160487|NCT01465425|"~     The ACRIN 7151 trial will use medical records abstraction data from participants with~     extracolonic findings (ECFs) reported from the ACRIN 6664 National CT Colonography Trial to:~     1) measure incidence of diagnostic imaging, hospitalization, and interventional procedures~     associated with ECFs reported on computed tomography colonography (CTC), delineated by type~     of ECF; 2) determine potential predictors of follow-up diagnostic imaging, hospitalization,~     and interventional procedures, delineated by type of ECF; and 3) evaluate the~     clinical/pathologic diagnoses associated with indeterminate but potentially significant ECFs.~     These data can be used to incorporate ECFs into existing models on the cost-effectiveness of~     CTC in colorectal cancer screening and can potentially be used to develop guidelines for the~     reporting and management of ECFs.~   "
160823|NCT01460966|"~     Attenuated plaque ≥ 5mm by intravascular ultrasound(IVUS) was reported to be high risk for~     distal embolism in Acute coronary syndrome(ACS). The purpose of this study is to assess the~     effect of thrombus aspiration catheter and distal protection device (filter wire; Filtrap™)~     in the aforementioned subgroup of patients at high risk for distal embolism.~   "
160488|NCT01465412|"~     The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after~     administration of a single 5 mg oral dose of preladenant in participants with hepatic~     impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with~     participants with mild hepatic impairment. Part 2 compares healthy volunteers with~     participants with moderate hepatic impairment. Healthy volunteers in each part of this study~     are to be matched with participants with hepatic impairment by race, age, gender, and body~     mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI,~     the area under the concentration-time curve from time 0 extrapolated to time of the last~     quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched~     healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within~     the interval [0.50, 2.00].~   "
160489|NCT01465399|"~     Immediately following tooth removal, a healing process begins that affects the eventual~     alveolar bone volume and architecture of the alveolar ridge. Satisfactory and timely healing~     are essential to obtain ideal functional reconstruction. Traumatic removal of a tooth, or a~     poor healing response, may lead to excessive bone loss delaying tooth replacement, requiring~     expensive and time-consuming reconstructive surgeries, or even the inability to be corrected.~     The Plasma Rich in Growth Factors (PRGF-Endoret) has shown its therapeutic potential effect~     to minimize the consequences of this aggression, promoting the regeneration of both hard and~     soft involved tissues.~   "
160490|NCT01465386|"~     This phase II trial studies how well bortezomib works in treating patients with high-risk~     acute myeloid leukemia (AML) in remission. Bortezomib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth~   "
160491|NCT01465373|"~     The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment~     techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.~   "
160492|NCT01465360|"~     The purpose of this study is to assess the performance of AclarusDx™, an investigational~     blood test detecting gene expression information, and intended to help physicians in making~     an Alzheimer's Disease diagnosis in patients having memory impairments.~   "
160493|NCT01465347|"~     This open-label study evaluated the safety and efficacy of TSC when dosed concomitantly with~     the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in~     adults. All patients received TSC in the study. The objective of the study was to evaluate~     the effect of TSC on survival and tumor response in patients with GBM while establishing an~     acceptable patient risk profile.~   "
160494|NCT01465334|"~     The main purpose of this study is to examine how two separate groups of 17p deletion Chronic~     lymphocytic leukemia (CLL) participants respond to sequential treatment with this particular~     combination of drugs. The two groups are those participants who have previously received~     treatment for their CLL and those who have not yet received any treatment. The combination of~     drugs is Ofatumumab and High-Dose Methylprednisolone (HDMP) first followed by Ofatumumab and~     Alemtuzumab. All three drugs are FDA approved and have known activity in treating 17p CLL. We~     hope that by combining these drugs together in this study, they will have more benefit than~     each one alone and that the subjects' CLL will be significantly impacted.~   "
160495|NCT01465308|"~     The purpose of this study is to determine whether the use of pure honey will help in the~     treatment of radiation induced xerostomia and oral mucositis (symptom management)~   "
160496|NCT01465295|"~     The purpose of this clinical trial is to study a new method of treatment for patients who are~     diagnosed with idiopathic scoliosis and have abnormal and increasing curvature of the spine.~     The treatment consists of the surgical implantation of a new medical device called the~     HemiBridge™ Clip. This medical implant device has never been used in humans. SpineForm,~     LLC, the developer of the HemiBridgeTM System has designed this scientific clinical trial, to~     evaluate the safety of the use of this device in humans. Information collected from patients~     treated with this new device shall be used to determine the initial safety of the new device.~      The FDA has approved the use of the HemibridgeTM System for this research study in 6 (six)~     pediatric patients who have idiopathic scoliosis.~      This procedure is intended to stop additional curvature of the spine by redirecting growth of~     the bones of the spine (vertebrae). To accomplish this, the patient undergoes a surgical~     procedure to securely attach small metal clips (HemiBridge™ Clips) to the outer side of each~     vertebra involved in the curvature. The HemiBridge™ Clip forms a bridge between each~     vertebra and is intended to hold the vertebrae in place to prevent the spine from curving any~     further.~   "
160497|NCT01465282|"~     The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327~     ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up~     to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.~   "
160498|NCT01465269|"~     The aim of this study is to determine the effectiveness of holistic group treatment program~     (called Group Interactive Structured Treatment, or GIST) to improve social communication~     skills for individuals with Traumatic Brain Injury. Hypothesis: Compared to an alternative~     intervention, those receiving the GIST intervention will show improved social competence,~     improved quality of life, and stronger group cohesion.~   "
160499|NCT01465256|"~     The purpose of this study is to determine if the use of aspirin prior to colonoscopy~     increases the risk of post polypectomy bleeding. The primary end point is comparison of~     bleeding rates after polypectomy of a continuous aspirin group and temporally aspirin-quit~     group. The secondary end point is analysis of risk factors which affect early or delayed post~     polypectomy bleeding.~   "
160500|NCT01465243|"~     To determine whether dose escalation can provide a better survival to patients who failed~     with icotinib at routine dose.~   "
160501|NCT01465230|"~     This study will determine whether or not Lenalidomide improves effectiveness of treatment for~     chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the~     disease (bendamustine and rituximab).~   "
160509|NCT01465126|"~     Background: Collagen IV-related nephropathies can lead to End Stage Renal Disease.~     Experimental studies have shown renin angiotensin aldosterone system blockade can reduce~     proteinuria and preserve renal function. In humans there is no proven treatment. Methods:~     This is a retrospective study of patients with Collagen IV-related nephropathies and~     proteinuria treated with enalapril analyzing the evolution of proteinuria and renal function,~     as well as predictive variables of progression to end stage renal disease. Outcome was~     creatinine clearance < 60 ml/min/1.73m2.~   "
160502|NCT01465217|"~     Uncontrolled high blood pressure (HBP) is a major public health concern and leading cause of~     cardiovascular disease worldwide. The HBP crisis is particularly onerous to African Americans~     as they are disproportionately more susceptible to HBP than non-Hispanic White Americans.~     Poor adherence to prescribed medication regimens is a major problem, as only about half of~     patients who have been diagnosed with hypertension adhere to prescribed medications. Mobile~     phones and text messages are becoming widely integrated into routine daily life and may offer~     a simple and non-labor intensive strategy for improving the quality of medication management~     through enhancing medication adherence. This proposed research will be conducted in two~     distinct phases addressing three specific aims. For Specific Aim 1 (Phase I), the~     investigators propose to conduct focus groups with participants from the investigators target~     population in order to obtain feedback to guide the development of a mobile phone text~     message system that seeks to improve adherence to antihypertensive medications. For Specific~     Aim 2 (Phase II), the investigators propose to pilot test the newly developed text message~     intervention with a randomized controlled trial. For Specific Aim 3 (Phase II), the~     investigators propose to ascertain participant perceptions of intervention effectiveness and~     satisfaction in order to guide further system refinement. In Phase I, African Americans with~     uncontrolled hypertension (n=24-32) will be recruited to take part in one of four focus~     groups that will help guide the development of the text message intervention. In Phase II,~     African Americans with uncontrolled hypertension will be randomized to receive usual care~     (n=30) vs. the text message intervention (n=30). The primary outcome in this pilot will be~     change in medication adherence at one month follow-up; secondary outcomes include change in~     medication self-efficacy and systolic and diastolic blood pressure at one month follow-up, as~     well as participant satisfaction with the text message intervention. The proposed research~     will utilize the Wayne State University (WSU) Center for Urban Studies to conduct high~     quality and professionally run focus groups, the WSU Division of Computing and Information~     Technology's Broadcast Message Service infrastructure for the delivery of text messages, the~     WSU Center for Health Research for statistical analysis and grant management assistance, and~     a diverse study team from a variety of disciplinary backgrounds at WSU. As a result, the~     proposed research leverages the considerable local resources to investigate an innovative and~     much needed intervention for this high-risk population.~   "
160503|NCT01465204|"~     This study consists of an impact evaluation (IE) of the Scaling up Handwashing with Soap~     (HWWS) and Total Sanitation and Sanitation Marketing (TSSM) projects of the Water and~     Sanitation Program (WSP) of the World Bank. The objective of this study is to estimate the~     causal impact of the HWWS and TSSM interventions on the health and welfare of the rural poor~     in six developing countries: Peru, Tanzania, Senegal, Vietnam, Indonesia, and India. The IE~     will assess the impact of exposure to the HWWS and TSSM promotion on individual-level hygiene~     and sanitation practices, and on the health and welfare of children 0-5 years old. By~     introducing exogenous variation in handwashing and sanitation practices (through exposure to~     the HWWS and TSSM promotion), the IE will also answer a number of important questions related~     to the effect of the intended behavioral change (handwashing and improved sanitation) on~     health and welfare, thus providing information on the extent to which these behaviors alter~     intended development outcomes. This study uses a cluster-randomized experimental design,~     whereby the geographic units called clusters (e.g. village, commune, ward, depending on~     administrative structure of country) are randomly assigned to receive certain components of~     the Handwashing and Sanitation interventions in the case of treatment arms, and no~     Handwashing or Sanitation intervention in the case of control arms. . The final sample for~     the evaluation will consist of approximately 14,000 households, randomly selected, with at~     least one child between 0 and 24 months of age at baseline. Data will be collected from these~     14,000 households (approximately 54,781 subjects) through household surveys, anthropometric~     measurements, blood and stool samples, direct observations of behaviors, and community~     surveys. The data collected will be analyzed using a differences in differences approach,~     where possible, and the results will be disseminated to country officials and others~     stakeholders.~   "
160504|NCT01465191|"~     HYPOTHESIS: The response to a given dose of morphine given via a spinal anesthetic for~     cesarean section will be affected by the genetics of the woman's mu-opioid receptor~      Most women undergoing elective cesarean section (CS) receive spinal anesthesia, and most~     receive a dose of preservative free morphine with the spinal anesthetic.~     Spinally-administered morphine provides 16-24 hours of high quality pain relief. The dose~     administered is usually 75-200 micrograms, but surprisingly few dose-response studies exist.~      The mu-opioid receptor (OPRM1 gene)is the site of action of endogenous opioid peptides and~     opioid analgesic drugs like morphine. There is a common genetic variant of this receptor at~     the 40th amino acid of the protein, with asparagine and asparate being present in different~     people. The less common variant (aspartate), present in 25-30% of the overall American~     population (higher in Asian populations, lower in Blacks) at codon 40 that has been shown in~     many studies to affect opioid analgesia.~      This will be a randomized, blinded study of 3 doses of spinal morphine (50, 100, 150~     micrograms) given to women undergoing elective cesarean section at term pregnancy. 300 women~     will be studied (100 per dose). Blood will be obtained for genotyping of OPRM1 and other~     genes that may affect pain and analgesic responses. The primary outcome will be the amount of~     intravenous morphine patients self-administer in the 24 hours postsurgery.~      The primary outcome (use of intravenous morphine) will be analyzed by dose, and within each~     dose group by genotype of OPRM1. Secondary outcomes will include pain scores every 6 hours,~     satisfaction with analgesia, side effects (itching, nausea/vomiting) by dose and genotype.~      It is anticipated that there will be an interim data analysis at 150 evaluable subjects for~     assessment of the dose response to morphine in the overall population; then a final analysis~     at 300 subjects for the genetic effect assessment.~   "
160505|NCT01465178|"~     It is the investigators hypothesis that the current method of evaluating vitamin D status,~     measuring circulating 25-hydroxy vitamin D is not providing the full metabolic picture, and~     is therefore inadequate. The investigators liken this concept to the evolution of cholesterol~     where initially, total cholesterol was the only measurement, and have since determined the~     importance of HDL, LDL and triglycerides in evaluating patient status. Similarly, the~     investigators feel measurement of other vitamin D components such as sulfated vitamin D,~     circulating vitamin D3 and 3-epi 25-hydroxy vitamin D will offer more comprehensive~     information about a patient's vitamin D status.~      It is our overarching hypothesis that a vitamin D assay panel, will enhance understanding~     of vitamin D status. It is our expectation that the enhanced understanding based on improved~     measurement capability will ultimately translate to improved definition of vitamin D status~     and need for supplementation on an individual level.~   "
160506|NCT01465165|"~     Several lines of evidence support the existence of an underlying abnormality in brain energy~     metabolism may play a key role in the biology of mood disorders. The current study utilizes~     two distinct but complementary imaging techniques, fluorodeoxyglucose (FDG) positron emission~     tomography (PET) and multinuclear magnetic resonance spectroscopy (MRS), to better understand~     the nature of these metabolic abnormalities in major depressive disorder (MDD). The~     investigators hypothesize that individuals with depression will have increased metabolic~     activity as measured by PET in certain brain regions involved in mood regulation, but that~     this metabolic activity will be inefficient based on MRS findings. For this study, the~     investigators will study 10 medication-free, currently depressed participants with recurrent~     MDD, 10 depressed participants with recurrent MDD currently taking antidepressant medication,~     and up to 20 healthy control participants matched to depressed participants for age and~     gender. Depressed and healthy participants will each undergo one PET scan and one MRS~     scanning session.~   "
160507|NCT01465152|"~     This trial is conducted in Europe. The aim of this trial is to compare the efficacy of~     metformin and repaglinide used alone or combined administered as initial treatment in~     subjects with type 2 diabetes in which diet and exercise have failed.~   "
160508|NCT01465139|"~     CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune~     cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety~     and biological response for approximately one month or more.~   "
160535|NCT01464788|"~     Randomized controlled clinical trial to estimate overall treatment benefit (improvement in~     disability) among stroke patients treated with rt-PA who are randomized to also receive~     either low-dose Argatroban, high-dose Argatroban or neither.~   "
160510|NCT01465113|"~     This study is being conducted to determine if vitamin D supplementation increases the level~     of a protein that may be involved in decreasing the risk of esophageal cancer in patients~     with Barrett's esophagus. Subjects with Barrett's esophagus will take vitamin D~     supplementation for 2-12 weeks depending on the severity of their condition, and receive an~     upper endoscopy procedure before and after vitamin D supplementation trial.~   "
160511|NCT01465100|"~     The purpose of this research study is to determine whether partial irradiation of the liver~     and liver cell transplantation can reduce the need for dietary and medical management or~     could possibly eliminate the need for a special diet and medications to treat this disease~     for patients with phenylketonuria (PKU) by normalizing phenylalanine levels in the body.~     Phenylalanine (Phe) is a substance needed in the body that can only be obtained from the~     foods people eat. People with PKU cannot get rid of Phe in their body. Large amounts of Phe~     can cause problems, such as deterioration of mental function. At the present time, liver cell~     transplants are experimental and have been done in only a limited number of human subjects.~   "
160512|NCT01465087|"~     Multiple Sclerosis (MS) is a complex multi-factorial disease, with underlying both genetic~     and environmental factors. Different populations have different susceptibility to MS. The~     disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course.~     Clinical disability is due to distraction of the central nervous system (CNS) myelin.~      Repair processes are mainly noted after the acute relapse - and recovery of function can be~     spontaneous. However, in severe relapses sometimes there is need for STEROID TREATMENT.~      For the long term prophylaxis - following the increased understanding of the disease, in the~     last 10-15 years, there are new immunotherapies available (COPAXON / TEVA; Interferon -beta).~     However these can attenuate the disease (reduce the number of relapses per year) but cannot~     cure it. Also, they are beneficial in only ~40 % of the Relapsing -Remitting patients.~      Currently there are no biomarkers available for MS (other than oligoclonal Immunoglobulin G~     (IgG) in the cervical spine fluid (CSF) - which helps confirm diagnosis but require an~     invasive procedure and are not correlated with disease activity nor response to therapy) and~     monitoring of MS and its treatment is by magnetic resonance Imaging (MRI) - which is an~     expensive procedure.~      Dr Hossam Haick from the Technion developed an electronic nose based on nanomaterials for~     diagnosis of diseases (e.g., cancer, kidney failure, etc.) via breath samples.The research~     hypothesis is that Biomarkers of CNS inflammation and/or neurodegeneration and/or CNS repair~     in persons with MS can be detected by the electronic nose.~   "
160513|NCT01465074|"~     Patients with schizophrenia display cognitive impairments, such as reduced attention and~     problems with memory. Available medications for schizophrenia poorly alleviate memory~     problems however, research indicates that nicotine improves memory. In order for there to be~     memories formed, there has to be changes (neuroplasticity changes) in how the brain cells~     communicate. One way to induce such changes is by using Transcranial Magnetic Stimulation~     (TMS) combined with peripheral nerve stimulation in a Paired Associative Stimulation (PAS)~     paradigm. The investigators laboratory has developed a novel method that measures memory-like~     brain changes using electroencephalography (EEG), TMS and PAS. The present study will use~     this novel method to evaluate the effects of acute nicotine gum (4mg) and placebo (regular)~     gum on memory and memory-like brain changes in schizophrenia and healthy controls. The~     hypothesis is that nicotine will improve memory and facilitate neuroplasticity changes in the~     prefrontal cortex of patients with schizophrenia to a larger extent than in healthy controls.~   "
160514|NCT01465061|"~     With the rise of usage of the internet, online social networks have recently been gaining~     popularity. Joining these groups can be beneficial to patients with chronic medical illness,~     such as psoriasis.This was a cross-sectional online survey of psoriasis patients in the~     Philippines who are members of online support groups. The survey was conducted for a period~     of three months.The purpose of the research project was to describe the demographics, disease~     characteristics, activities and benefits of online support groups to Filipino patients with~     psoriasis. The extent to which members experience empowering processes and outcomes was also~     evaluated.~   "
160515|NCT01465048|"~     This is an open label, human pilot study to optimise controlled human malaria infection~     (CHMI) administered by Plasmodium falciparum sporozoites (PfSPZ. Volunteers will be~     inoculated with PfSPZ Challenge. The route of administration and dose will vary in order to~     identify the optimal regimen that achieves the greatest infection rate in volunteers with~     Plasmodium falciparum. All volunteers recruited will be healthy adults aged between 18 and 45~     years. Safety and infectivity data will be collected for each of the regimens.~   "
160516|NCT01465035|"~     This is a single blinded placebo controlled phase I study, to assess the safety and~     immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with~     seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over.~      The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV)~     is that the immune system will be stimulated to produce both influenza specific T cells and~     influenza specific antibodies.~   "
160517|NCT01465022|"~     Objectives~      To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined~     oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth,~     contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific~     research questions:~        1. To determine whether there is a difference in rates of breastfeeding continuation at 2~          months and 4 months between postpartum breastfeeding women using progestin-only pills~          vs. combined pills.~        2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks~          between postpartum breastfeeding women using progestin-only pills vs. combined pills.~        3. To determine whether there is a difference in birth control method continuation at 2~          months and 4 months between postpartum breastfeeding women using progestin-only pills~          vs. combined pills.~      Hypothesis~      Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will~     cause a differential in continuation of breastfeeding: 35% continuation in the combined pill~     group vs. 60% in the progestin-only pill group at 8 weeks.~   "
160518|NCT01465009|"~     The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study~     medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of~     sore throat associated with a common cold. The study is designed to develop a treatment~     method against sore throat associated with a common cold which will have more advantages for~     patients than the methods that are currently available.~   "
160519|NCT01464996|"~     This randomized clinical trial evaluates the clinical performance of a new two-component~     self-etch universal adhesive, OptiBond XTR, when applied in non-carious Class V cervical~     lesions without macromechanical retention (retentive grooves or bevels). The control material~     is OptiBond FL, a traditional etch/prime/bond adhesive with documented clinical~     performance. Eighty non-carious Class V cervical lesions are divided into two groups to be~     treated with either OptiBond XTR or OptiBond FL. Both adhesives are applied strictly~     according to the manufacturer's directions. Herculite Ultra, a nano-hybrid resin-based~     composite, is used as the restorative material with both adhesives. The restorations will be~     evaluated at insertion (baseline), 6 months, and 18 months. An optional three-year recall~     evaluation is also proposed. The investigators hypothesize that both adhesives will have~     comparable performance.~   "
160520|NCT01464983|"~     The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg~     Aspirin® (study medication) by comparing it to placebo (the control group without active~     substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of~     episodic tension-type headache. The study is designed to develop a treatment method against~     episodic tension-type headache which will have more advantages for patients than the methods~     that are currently available.~   "
160521|NCT01464970|"~     The purpose of this study is to determine in-vivo the effects the contralateral superficial~     inferior epigastric vascular system has on the perfusion of Zone IV of deep inferior~     epigastric perforator flaps.~   "
160522|NCT01464957|"~     Skin cancer risk is largely determined by sun exposure during childhood. This study~     determines the effectiveness of a mailed intervention designed to increase sun protection for~     children age 6-9 years old. The intervention includes newsletters for parents that include~     risk information tailored to each child. Also included are sun protection resources such as a~     swim shirt, a sun hat, and sunscreen. Participants receive the intervention over 3~     consecutive years, and data collection includes telephone interviews and skin exams. The~     study hypothesis is that receipt of the intervention will result in improved sun protection~     of the child.~   "
160523|NCT01464944|"~     This study is addressed to patients suffering from an acute febrile upper respiratory tract~     infection suspected to be of viral origin. The purpose of this study is to determine the~     antipyretic efficacy (reduction of fever by lowering the body temperature from a raised~     state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of~     Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo~     (comparator medication without an active substance). Despite of its common use for fever~     treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin~     are sparse. Therefore, the purpose of this study is to collect such data.~   "
160524|NCT01464931|"~     The primary objective was to evaluate the incidence of clinically significant hypocalcemia~     following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic~     kidney disease (CKD) and CKD on dialysis~   "
160525|NCT01464918|"~     This trial is to evaluate the safety and efficacy of using MASTER, a robotics enhanced~     endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer~     in human.~   "
160526|NCT01464905|"~     The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with~     relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active~     comparator. The primary clinical objective selected for this Phase 3 study, the cumulative~     number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted~     lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance~     imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the~     superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively.~   "
160527|NCT01464892|"~     Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early,~     chronic, interpersonal trauma (e.g. Smucker & Dancu, 1999). So far, this protocol has not~     been investigated within a controlled setting with patients with PTSD following early,~     chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the~     efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can~     be improved by adding a stabilization phase (Skills training in affective and interpersonal~     regulation, STAIR) prior to this treatment. In a randomized controlled trial three conditions~     will be compared:~        1. Imagery Rescripting~        2. STAIR + Imagery Rescripting~        3. Wait-list control~   "
160528|NCT01464879|"~     This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum~     testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the~     pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand~     application~   "
160529|NCT01464866|"~     This study will determine the effect of nutrition supplementation on blood protein levels in~     pediatric burn patients.~   "
160530|NCT01464853|"~     To determine whether specialized enteral nutrition support can improve oxygenation status in~     critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome~     (ARDS) comparing to a standard enteral nutritional formula.~   "
160531|NCT01464840|"~     PKAZ is a single institution study designed to evaluate the optimal dosing parameters for~     azithromycin for pre-surgical cesarean prophylaxis.~      Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal~     tissue concentrations that adequately treat microbes commonly involved in post-cesarean~     infections.~   "
160532|NCT01464827|"~     This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin~     (RBV) in patients with chronic Hepatitis C Virus (HCV).~   "
160533|NCT01464814|"~     The purpose of this study is to determine the effects of the probiotic KE-99 Lactobacillus~     casei when administered with omega-3 fish oil on probiotic viability, fecal make-up and~     gastrointestinal (GI) health in healthy adults.~   "
160534|NCT01464801|"~     Non-alcoholic fatty liver disease (NAFLD) and fatty liver hepatitis (NASH) are very common in~     the Western world and strongly associated with obesity. No known effective treatment is~     known. From animal studies, it is known that the compound resveratrol perhaps has the~     potential to neutralize obesity-induced diseases. Resveratrol is already widely used as a~     food supplement though the precise effects are unknown. This project focuses on the effect of~     Resveratrol on fatty liver disease. The researchers plan to investigate the effects of~     Resveratrol or placebo treatment for 6 months on NAFLD/NASH in obese patients.~   "
160536|NCT01464775|"~     Endometriosis is a relatively common chronic gynecological condition that affects~     approximately 10% of all women of reproductive age. It is a pelvic inflammatory disease that~     is characterized by the presence of endometrial glands and stroma outside of the uterine~     cavity. Typical symptoms of endometriosis include dysmenorrhea, pelvic pain, and infertility;~     the severity of pain associated with this disease often leads to a considerable decrease in~     quality of life.~      The standard treatment for severe pelvic pain and infertility is to surgically remove~     endometriotic areas. Identifying all endometriotic lesions is paramount to optimal~     endometriosis debulking. The inability to see all endometriosis lesions has been thought to~     be a factor for patients with little or no relief following surgery. Using the Narrow Band~     Imaging (NBI) method has the potential to improve visualization of endometriosis lesions,~     assist in debulking and thus, result in improved clinical outcomes.~      NBI is a technique that uses a specific narrow wavelength of light to change the normal color~     contrasts of the endoscopic image and improve detection of neovascularization, which is the~     pathological feature of endometriosis for both superficial and deeper vascularization. This~     type of imaging has the potential to offer improved discrimination of lesions, increasing~     diagnostic yield as well as resulting in more complete debulking.~      This study is designed to determine the degree to which NBI improves the detection and~     diagnosis of endometriosis lesions. Data collected during the study will be used to test the~     hypothesis that the use of NBI will improve the detection and diagnosis of endometriotic~     lesions at the time of laparoscopy compared to standard visible white light examination.~     Furthermore, this study will also determine the impact of the use of NBI compared to use of~     white light examination on reported severity of pain at 6-weeks, 3-months, and 6 months~     following surgery.~      Hypotheses:~      The use of NBI in addition to white light examination will improve the diagnostic yield of~     endometriotic lesions at the time of laparoscopy compared to only using white light~     examination.~      The use of NBI in addition to white light examination will improve the sensitivity of~     detecting endometriotic lesions and reduce false positives at laparoscopy compared to only~     using white light examination.~      Secondarily, the use of NBI will be associated with a greater reduction in pain at the~     6-week, 3-month, and 6-month follow-up compared to the use of white light examination alone~     because of improved lesion identification and debulking.~   "
160537|NCT01464762|"~     The purpose of this is a study to provide early access of TMC207 to patients with pulmonary~     infection due to strains of Mycobacterium tuberculosis (M. tuberculosis) with resistance to~     isoniazid (INH), rifampin (RMP), and to a fluoroquinolone (FQ) and/or injectable second line~     tuberculosis (TB) drug (kanamycin, amikacin, or capreomycin) and who are unable/ineligible to~     participate in any other TMC207 study. In addition, information on safety and tolerability of~     TMC207 in combination with anti-TB drugs will be assessed and the results of microbiology~     assessments which are recommended to be performed during the early access study will be~     collected.~   "
160538|NCT01464749|"~     Aims of the study:~      This is a single blind randomized-controlled trial to test the feasibility and the effects of~     a task oriented training on locomotor function, mobility and balance in multiple sclerosis~     subjects with moderate gait impairments (EDSS 4 - 5,5). The control group will not be treated~     with a specific physical therapy (usual care).~      Subjects and methods:~      60 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic~     (Azienda Ospedaliero-Universitaria di Ferrara).~      Informed consent will be obtained. Participants will be randomized to (TOCT) task-oriented~     training (experimental group) or usual care (control group) through a randomization~     stratification approach, according to a block randomization of 6.~      The experimental group will receive 10 task-oriented training sessions over 2 weeks (5~     sessions/week=intensive training). Three subjects with a supervisor physiotherapist will take~     part at the TOCT.~      Feasibility outcome will be measured with a specific questionnaire. Treatment efficacy~     outcome measures will be clinical test for gait speed (10m walking test), walking endurance~     (six minute walking test), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); a~     structured interview for the performance(Lower Extremity Mal); self-assessment questionnaire~     for motor fatigue (Fatigue Severity Scale FSS), multiple sclerosis physical and psychological~     impact (multiple sclerosis impact scale MSIS-29), walking ability (multiple sclerosis walking~     scale MSWS-12).~      Outcome measures will be assessed the week before the treatment (T0), after the treatment~     (T1) and at 3 months follow-up (T2) to evaluate treatments retention, by a clinician blinded~     to the treatment.~   "
160539|NCT01464736|"~     On the following tests, there would be a greater increase in the functionality of COPD~     patients who underwent combined therapy than in those who only exercised: a set of activities~     of daily living (ADLs), the six-minute walk test (6MWT), an incremental symptom-limited~     cardiopulmonary test (CPT), and the physical functioning scale of the Short-Form 36 quality~     of life questionnaire (SF-36).~   "
160540|NCT01464723|"~     The purpose of the study is to investigate whether the efficacy of Lucentis treatment for~     exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA~     polymorphisms~   "
160541|NCT01464710|"~     The purpose of this study is to determine if polymorphisms at rs11200638 on HTRA1 and~     rs1061170 on CFH are associated with an accelerated progression to advanced AMD (wet AMD or~     GA) in patients with early AMD (soft confluent drusen>120 microns ) in the study eye, and~     with either early AMD or advanced AMD in the non-study eye.~   "
160542|NCT01464697|"~     The purpose of this study is to test whether a oral micronized progesterone reduces the~     Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats~     in perimenopausal women. Oral micronized progesterone is molecularly identical to human~     progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial~     cancer in women taking estrogen in menopause. This research study will test whether~     progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether~     progesterone improves sleep disturbances and anxiety.~   "
160543|NCT01464684|"~     Investigators will characterize the body composition and metabolism of infants born from~     lean, overweight or obese mothers from whom they had previously obtained a placenta and/or~     cord blood as part of the earlier placenta and cord blood study (#111576)~   "
160544|NCT01464671|"~     The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin)~     versus unfractionated heparin (UFH) in patients presenting with stable angina or silent~     ischemia (positive stress test without chest pain) that undergo percutaneous coronary~     intervention (PCI).~      The primary endpoint of the study will be major and minor bleeding events, defined by the~     REPLACE-2 trial definition, during the index hospitalization and up to 30 days post~     discharge.~   "
160574|NCT01464268|"~     Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing~     progression of both keratoconus and corneal ectasia after surgery, as well as possibly~     decreasing the steepness of the cornea in these pathologies. During previous studies of the~     CXL procedure, the surface epithelial cells have been removed. Transepithelial crosslinking~     in which the epithelium is not removed has been proposed to offer a number of advantages over~     traditional crosslinking including an increased safety profile by reducing the risk for~     infection as no epithelial barrier will be broken, faster visual recovery and improved~     patient comfort in the early postoperative healing period.~   "
160575|NCT01464255|"~     This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week~     crossover, daily wear regimen.~   "
160545|NCT01464658|"~     Patients with morbid obesity often develop a significant overhanging abdominal pannus.~     Problems associated with an overhanging pannus can include difficulty performing routine~     daily activities as well as exercise due to the cumbersome nature of the excess tissue. In~     addition, the abdominal pannus tissue often becomes infected due to difficulty with hygiene~     and abnormal circulation and lymphatic flow. There may also be a significant contribution~     from the pannus to the patient's underlying cardiopulmonary status which is often compromised~     in morbid obesity patients.~      In addition to weight loss, one of the treatment strategies includes a panniculectomy. A~     panniculectomy involves resection of the excess abdominal skin and fat in a wedge shape from~     the lower abdomen. Purported benefits include increased ability to exercise, better quality~     of life and improved cardiopulmonary function. However, there is a significant morbidity~     associated with panniculectomy surgery, with wound related complications occurring in as much~     as 50% of patients with this procedure.~      The investigators hypothesize that the panniculectomy procedure provides long term benefits~     to this patient population despite significant short term morbidity.~   "
160546|NCT01464645|"~     The purpose of this study is to examine the short term efficacy of the MRH system as well as~     determine if operating room time is decreased using this simple, two-tray system.~   "
160547|NCT01464632|"~     The purpose of this study is to determine the short-term (2 yr) and midterm (5 yr) cumulative~     revision rates of the EPIK™ Uni-compartmental Knee System.~   "
160548|NCT01464619|"~     The main objective of this study is to adapt a parenting intervention for caregivers of young~     children who report depressive symptoms in primary care pediatric practices. In addition, the~     study will explore the acceptability and feasibility of a validated parenting program.~   "
160549|NCT01464606|"~     Pleuropulmonary Blastoma (PPB) is very rare and there is no established standard or best~     therapy. For many years, children with PPB around the world have been treated according to~     decisions made case-by-case in many different hospitals by many different physicians. No~     treatment has been tested in a large group of PPB patients.~      The goal is to treat many children with one treatment program and to learn the results of the~     treatment.~   "
160550|NCT01464593|"~     The purpose of this study is to determine the safety and efficacy of Thermodox, a thermally~     sensitive liposomal doxorubicin, in combination with thermal ablation in the treatment of~     hepatic colorectal liver metastases (CRLM).~   "
160551|NCT01464567|"~     Weaning of mechanical ventilation (MV) is an essential part in management of patients with~     Chronic Obstructive Pulmonary Disease (COPD) when critically ill. The best strategy to be~     used has not been established.~      Objective: To compare the Spontaneous Breathing Trial (SBT) in Pressure Support Ventilation~     with SBT through T tube in weaning of MV in patients with COPD.~      Design: Randomized Clinical Trial. Methods: This study will include patients with COPD,~     admitted to the Intensive Care Unit of Hospital Nossa Senhora da Conceição, undergoing MV for~     at least 48 hours. When considered by the care team ready for SBT, they will be randomized to~     one of the following strategies: SBT in Pressure Support or SBT through T Tube. The primary~     endpoint of this study will be the reduction in the days spent on MV. Other outcomes measured~     will be mortality, extubation and success rate, time to weaning of MV, length of ICU stay and~     incidence of tracheostomy.~   "
160552|NCT01464554|"~     Youth involved in the juvenile justice system have multiple problems, including an earlier~     onset of alcohol and drug use and higher rates of alcohol and drug use than their peers in~     the general population. This 4.5 year study will develop and evaluate a new group~     intervention for youth who have committed a first time alcohol or drug offense. Teens will be~     randomized to receive either usual care or the new group intervention. Teens will complete a~     baseline, post-test (when they complete the intervention, which could vary for each teen but~     is typically around 6-8 weeks), and a 3-month follow-up survey upon completion of the~     intervention. The investigators will examine outcomes for a variety of behaviors, including~     alcohol and drug use and assess whether there are differences between the teens who received~     usual care and the teens who received the new group intervention.~   "
160553|NCT01464541|"~     Purpose to compare the orbital fracture size measured by orbital CT scan and compare it to~     the actual orbital fracture size intraoperatively in patients who needed surgical~     intervention to correct the fracture.~      Hypothesis: there is difference between the CT measure fracture size and the actual~     intraoperative size.~   "
160554|NCT01464528|"~     Operations in the uterus are currently possible using a hysteroscope. One serious though rare~     complication of such procedures is the development of intra-uterine adhesions. There~     currently are no methods to prevent this. The aim of this study is to evaluate the safety of~     using hyaluronic gel after hysteroscopic surgery.~   "
160555|NCT01464515|"~     This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation~     (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild~     Cognitive impairment). The hypothesis of the study is that high frequency treatment with deep~     TMS will improve the daily functioning of patients who suffers from MCI.~   "
160576|NCT01464242|"~     The purpose of this study is to determine whether adding pentoxifylline to treatment of~     American cutaneous leishmaniasis with meglumine antimoniate increases the rate and speed of~     clinical response without diminishing safety, and to identify immune correlates of the~     healing response.~   "
160577|NCT01464229|"~     Iloperidone is an atypical antipsychotic drug, FDA-approved for the acute treatment of~     schizophrenia in adults in 2009 (Marino et al., 2010); moreover, some of its pharmacological~     features seem to be very promising in treating symptoms like anger and anxiety (Fava et al.,~     1997; Wang et al., 2010). The investigators therefore feel that an adequately sized, well~     powered, double-blind, placebo-controlled, randomized, cross-over study of iloperidone~     augmentation of SSRIs among MDD outpatients in partial remission with residual anger and~     irritability is warranted at this point to evaluate its efficacy, safety and tolerability on~     residual anger, irritability and depressive symptoms.~      Main hypothesis: Adults with MDD in partial remission, who are experiencing residual symptoms~     of anger and irritability, assigned to treatment with iloperidone will demonstrate a~     significantly greater reduction in the total score of the Anger/Hostility Scale of the~     Symptom Questionnaire from baseline to endpoint than those assigned to placebo using the~     cross-over design.~   "
184163|NCT01154244|"~     The purpose of this study is investigating the clinical characteristics of newly diagnosed,~     drug naïve type 2 diabetic patients according to insulin secretion and insulin resistance.~   "
160556|NCT01464502|"~     Heart failure patients may benefit from having a special pacemaker implanted that can make~     the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy~     (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in~     optimal positions. Only two thirds of people respond to CRT and this may be because of~     non-ideal pacing wire position. A potential marker for response is the change in heart pump~     pressure change over time. The aim of this study is to use a specialised wire in the main~     pumping chamber of the heart to record the pressure changes with the pacing lead in various~     positions to determine the optimal position. It is postulated that the improved pressure~     changes will increase the proportion of responders.~      Pilot study work has shown that the work is technically feasible and safe. The initial data~     has been published in a highly regarded scientific journal. This main study will be a~     multicentre randomised controlled trial whereby patients will be randomised to either~     standard treatment or pressure wireguided treatment. The patients in the pressurewire guided~     arm will have a specialised wire implanted into the main pumping chamber of their heart via a~     blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). This will~     measure acute pressure changes over time and the pacing lead will be positioned in the site~     that gives the greatest change in pressure.~      If the patients in the pressurewire guided arm fare better than those receiving standard~     treatment it may alter how a large proportion of heart failure patients are treated around~     the world. The study requires 282 patients and is likely to take two years to complete.~   "
160557|NCT01464489|"~     The investigators hypothesized that increasing the cardiac output by use of atropine in~     children might result in a reduction of the intubation time needed to facilitate tracheal~     intubation.~   "
160558|NCT01464476|"~     This study will evaluate the efficacy and safety of Azimilide on the incidence of~     cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular~     death in patients with Implantable Cardioverter Defibrillators (ICDs)~   "
160559|NCT01464463|"~     The objective of this study is to compare the impact of i) Cognitive Behavioral Therapy (CBT)~     combined with exercise, ii)CBT combined with euthymic therapy, and iii) 'Cognitive Behavioral~     Analysis System of Psychotherapy' (CBASP) on psychometric and immunological measures in~     patients with major depression.~   "
160560|NCT01464450|"~     The primary objective of this study is to learn about the relative bioavailability (the~     extent to which the drug becomes available to the body) and pharmacokinetics (blood levels)~     of rivaroxaban in healthy participants after receiving a 20 mg rivaroxaban tablet orally as a~     whole tablet, crushed and mixed in applesauce, and as a suspension through a Naso-gastric~     (NG) tube. The relative bioavailability of rivaroxaban may be different when given as a~     crushed tablet compared with an intact (whole) tablet and when given via an NG tube. The~     safety and tolerability of rivaroxaban will also be assessed.~   "
160561|NCT01464437|"~     This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel~     group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated~     with metformin for at least 3 months prior to randomization.~   "
160562|NCT01464424|"~     The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs.~     bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with~     open-angle glaucoma or ocular hypertension after 6 weeks of treatment.~   "
160563|NCT01464411|"~     The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy~     for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.~   "
160564|NCT01464398|"~     The purpose of this study is to determine the effects of stress reduction on glucose, blood~     pressure, quality of life and overall health and well-being in overweight or obese women,~     either with Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction~     treatment sessions will include one or more of the following activities: breathing exercises,~     meditation, stretching exercises or health education activities.~   "
160565|NCT01464385|"~     To evaluate the sensations experienced by subjects consuming a nutritional beverage.~   "
160566|NCT01464372|"~     The purpose of this study is to collect data on the safety and efficacy of using an~     electrical field stimulation device, compared to a sham (placebo) device, to treat urinary~     urgency, urinary frequency and urge incontinence.~   "
160567|NCT01464359|"~     This trial is proposes to build on our experience and is designed to maximize early (day~     3-14) and late (day 60-71) donor-derived natural killer (NK) cell expansion and function in~     vivo. The proposed platform will allow us the unique opportunity to compare in vivo function~     from a transplanted umbilical cord blood (UCB) source (presumed to contain NK progenitors~     requiring education in the recipient).~   "
160568|NCT01464346|"~     The purpose of this study is to demonstrate the performance of the Enlite Sensor over an~     entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and~     buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.~   "
160569|NCT01464333|"~     This study of Humira will be conducted to obtain information on the safety (especially~     profile of malignant tumors and serious infections) and effectiveness in patients with~     Crohn's disease who are receiving Humira for a long period of time.~   "
160570|NCT01464320|"~     To assess the safety, tolerability and pharmacokinetics of ABT-614 in subjects with type 2~     diabetes and chronic kidney disease with albuminuria and to determine whether ABT-614 reduces~     glomerular filtration rate.~   "
160571|NCT01464307|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of the leg are effective in treating patients with increased muscle~     tension/uncontrollable muscle stiffness (spasticity) after a stroke.~   "
160572|NCT01464294|"~     Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar~     performance in clinical service to conventional ceramic CAD/CAM restorations.~   "
160573|NCT01464281|"~     A Randomized, open-label, multicenter study.~      The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA~     <200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap~     with the NA for safety reasons). The subjects will be randomized into 2 groups:~      Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week~     prolonged treatment by Peginterferon alfa 2a 180µg/week.~      All the patients will be followed up for 48 weeks after discontinuation of the study~     medication.~      Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.~   "
160579|NCT01464203|"~     Heart disease remains the most common cause of death in the UK. Chest pain is often the first~     presenting symptom in patients with heart disease, and may be a warning signal prior to a~     heart attack or death. The diagnosis based on symptoms alone however is unreliable and~     further testing is almost always necessary.~      Rapid access chest pain clinics (RACPCs) are able to expedite the assessment of such~     patients. The principal investigation used is an exercise stress electrocardiogram (s-ECG).~     Although simple, cheap, and convenient, the s-ECG is often inaccurate; missing the diagnosis~     or falsely suggesting the diagnosis. This can happen in as many as 25% of patients, resulting~     in a delay in treatment or unnecessary further investigation.~      CT Angiography (CTA) is a novel non-invasive technique where the coronary arteries can be~     visualised by Computerised Tomography. In previous studies it shows a high degree of~     correlation with invasive angiography, with a high accuracy for the diagnosis of obstructive~     coronary artery disease. However, the technique is relatively new, and its full role is yet~     to be defined in the clinical setting of a chest pain clinic. The investigators do not at~     present have any information as to whether it is able to speed up the diagnosis, reduce the~     need for other tests, and therefore also costs.~      In this trial, the investigators aim to examine the accuracy and cost effectiveness of CTA in~     patients with suspected cardiac chest pain presenting to a chest pain clinic, when compared~     to the more established techniques like s-ECG, myocardial perfusion scanning and coronary~     angiography. The study will enable us to establish the optimal and most cost effective~     strategy for investigation of patients presenting to chest pain clinics.~   "
160580|NCT01464190|"~     This is a Phase 3, randomised, active controlled, multicentre extension study to investigate~     the long-term safety and efficacy of PA21, a phosphate binder, for control of~     hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A~     (NCT01324128), subjects have already been enrolled and have been treated with study~     medication for at least 24 weeks.~   "
160581|NCT01464177|"~     Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment~     comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite~     appropriate management, 90% of the patients will develop relapse or progression. After~     progression, the median survival is 5.2 months (Stupp, 2009).~      The treatment of GBM relapse remains investigational. Reirradiation is an option in selected~     cases.~      The objective of this study is to compare 2 schemes of stereotactic hypofractionated~     radiotherapy in the management of recurrent GBM.~   "
160582|NCT01464164|"~     The purpose of this study is to determine the safety and dosing of drug Sotatercept, as a~     subcutaneous injection, to stimulate production of red blood cell production. To be given~     every 28 days for up to four doses.~   "
160583|NCT01464151|"~     Both ulcerative colitis and Crohn's colitis are associated with an increased risk of~     developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is~     well established, several studies show that the risk varies widely between patients,~     depending on the presence of risk factors. Recently, several of these risk factors were~     implemented in the updated British guidelines for surveillance which are now used to~     determine surveillance intervals in our center. The new guideline recommends stratification~     of patients in a high, medium or low risk group depending on the presence of clinical and~     endoscopic risk factors and to adjust the surveillance interval accordingly. Although these~     guidelines provide a first step towards an individualized surveillance regimen, current data~     regarding risk factors for IBD-associated CRC are solely based on retrospective studies.~     Prospective data on the phenotype and genotype reliably predicting the risk of CRC is needed~     to further optimize surveillance in the future.~      Objectives:~        1. To confirm established and identify new predictive factors for colorectal cancer in a~          prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or~          colorectal cancer will be the primary outcome.~        2. To provide evidence that mucosal healing results in a significant reduction of~          colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA or~          anti-TNF maintenance therapy.~        3. Study the expression of several tumor markers in biopsies, blood and faeces at baseline~          and determine whether expression of these markers can predict dysplasia or colorectal~          cancer development during follow-up.~   "
160584|NCT01464138|"~     This is an open label uncontrolled study to determine the efficacy of fosmidomycin and~     clindamycin when co-administered orally over three days in the treatment of acute~     uncomplicated Plasmodium falciparum malaria in children.~      The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary~     endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.~   "
160585|NCT01464125|"~     The aim of this study is to evaluate the role of azithromycin as a possible combination~     partner for fosmidomycin to protect it from its susceptibility to recrudescent infections~     when used as monotherapy for acute Plasmodium falciparum malaria while retaining its~     excellent safety profile.~   "
160586|NCT01464112|"~     The purpose of this study is to evaluate the safety and tolerability and to establish the~     maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.~   "
160587|NCT01464099|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in~     subjects with type 1 diabetes.~   "
160588|NCT01464086|"~     The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules~     for the early detection of cancers in the population under study on cancer incidence at 3~     years.~   "
160589|NCT01464073|"~     The purpose of this study is to evaluate the efficacy of 3 of physical exercise training~     programs, with a supplementation in fruits and vegetables, on body composition. 126 women~     will be randomized into 3 groups (42 subjects per group). The first program will be conducted~     at a relatively low intensity of effort, corresponding to the maximum rate of lipid oxidation~     (LIPOXmax)measured by indirect calorimetry. The second program will be at 60% of VO2peak and~     the third program will be prescribed according to the Good Practices physical Guidelines (30~     minutes per day at a moderate intensity). All subjects will receive a free supplement of 5~     fruits and vegetables per day during all the intervention. The intervention will last 5~     months in total.~   "
160890|NCT01460082|"~     The purpose of the study is to determine a possible association between the clinical entity~     of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients~     with COPD.~   "
160590|NCT01464060|"~     Helicobacter pylori (H. pylori) infects approximately 50% of the adult population and is well~     recognized as the main cause of gastritis, peptic ulcer disease and gastric cancer. The cure~     of the H. pylori infection prevents recurrence of duodenal and gastric ulcer and improves~     dyspepsia in a significant proportion of cases, so it is cost-effective.~      Eradication therapy has changed over time. Recent meta-analyses have that the current global~     eradication rate after standard triple therapy (STT) is less than 80%. Several European~     studies have found even lower eradication rates, with 35-40% of cases resulting in treatment~     failure, probably due to increased resistance to antibiotics in many geographical areas,~     principally to clarithromycin. The usually recommended pattern in the American and European~     (Maastricht III) consensus conferences from 2007 has traditionally been triple therapy,~     composed by the combination of 2 antibiotics (clarithromycin plus amoxicillin or~     metronidazole) and a proton pump inhibitor (PPI) for 7-14 days. However, triple therapy was~     discouraged in settings with high rates of clarithromycin resistance (15-20%) and, as such,~     new strategies in order to improve the efficacy of first-line treatments are required.~     Treatment failure increases antibiotic resistant strains, leads to a second treatment and a~     new diagnostic test to confirm eradication. Unfortunately, it remains unknown whether there~     is room for improvement in these geographical areas using clarithromycin-containing therapies~     or switching to bismuth quadruple therapy should be followed instead.~   "
160591|NCT01464047|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Sprycel® so that the regulatory authority can manage the marketing approval~     properly.~   "
160592|NCT01464034|"~     This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated~     dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients~     with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to~     evaluate efficacy.~   "
160593|NCT01464021|"~     A post-marketing uncontrolled observational study to explore and describe the effectiveness~     of adalimumab, as prescribed according to the local product label, in patients with~     moderately to severely active rheumatoid arthritis (RA) in China.~   "
160594|NCT01464008|"~     The efficacy of combination antiviral therapy for chronic hepatitis C is influenced by many~     factors. Important patient-specific factors include, age, gender, race, body weight.~     Important virus-specific factors include HCV genotype and serum HCV RNA level. Finally,~     important treatment-related factors include the type of interferon, dose of ribavirin and the~     duration and adherence to treatment.~      Despite the importance of patient- and virus-specific factors, the most important indicator~     of treatment success is a rapid, profound and sustained decrease in serum HCV RNA levels~     after the start of treatment.~      The on-treatment virological response can thus be used to predict the probability that a~     given patient will achieve an SVR if they remain on therapy. It can also be used to~     individualize the duration of treatment.~      In this study, treatment for patients with chronic hepatitis C was individualized on the~     basis of clinical characteristics and the on-treatment virological response. The aim was to~     investigate the usefulness of undetectable HCV RNA levels at week 4 (RVR) and 12 in tailoring~     the duration of treatment and predicting SVR in Chinese patients with chronic hepatitis C.~   "
160595|NCT01463995|"~     This study examines the prognostic properties of immune parameters, clinical scores,~     electrophysiological tests (eeg, ssep, emg, eng) and functional imaging for the prediction of~     functional outcome one year after treatment on a neurological intensive care unit.~   "
160596|NCT01463982|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan~     in combination with capecitabine~   "
160597|NCT01463969|"~     In the present study, serum pentraxin 3 level and its relationship with insulin resistance~     were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3~     level is increased in patients with PCOS and it is positively correlated with HOMA-IR.~   "
160598|NCT01463956|"~     Evaluation of efficacy of triple therapy with pegylated interferon, ribavirin, and boceprevir~     in patients with genotype 1 chronic hepatitis C, who are treatment-naive, have relapsed, or~     are non-responders with cirrhosis and awaiting liver transplantation, with a MELD score less~     than or equal to 18~   "
160599|NCT01463943|"~     The study's objective is to evaluate the efficacy and safety of two formulations for the~     prophylactic treatment of diarrhea in subjects using antibiotics.~   "
160600|NCT01463930|"~     Information provided to patients modifies their expectations with surgery. The effects of~     preoperative audiovisual information on expectations with total knee replacement (TKR) have~     not been investigated. The purposes of this study were to investigate the effectiveness of an~     educational videodisc on the modification of pre-operative patients' expectations with TKR~     and to find a biophysical profile of subjects in whom this videodisc could be most effective.~     It was hypothesized that patients receiving standard information plus additional medical~     information through audiovisual videodiscs would modify their pre-operative expectations more~     than those only receiving the standard information through medical interviews.~   "
160601|NCT01463917|"~     This is a comparison between Hypertonic versus isotonic solution in a double blind randomized~     trial for off pump Coronary Artery Bypass Graft (CABG) surgery targeting the left marginal~     branch.~      Hypertonic solution should provide better tolerance for heart mobilization with less volume~     expansion and less drugs.~   "
160602|NCT01463904|"~     Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy is a modified and simplified~     duodenal switch. It is performed on morbid obese patients and severe T2DM patients with~     obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and a~     remission of T2DM. A lower complication rate than for duodenal switch is expected.~   "
160603|NCT01463891|"~     To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with~     inoperable or recurrent breast cancer~   "
160679|NCT01462877|"~     Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk~     equivalents, whose TG level is not adequately controlled after statin monotherapy. According~     to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient~     who has insufficient improvement. The purpose of the study is to evaluate the efficacy on~     lipid control and the safety of adding fenofibrate in patients on a background of statin~     treatment.~   "
160604|NCT01463878|"~     Primary Objective:~      To determine the effects of a diabetes specific enteral formula compared to a standard~     formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose~     and glycemic variability in a homogenous group of critically ill patients in a neurological~     ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor.~     The primary end points will be the difference between the mean blood glucose levels and the~     glucose variability between the control and intervention groups for the time period that the~     patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.~      Secondary Objectives:~      To determine the effects of the diabetes specific versus standard tube feeds on the change in~     muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients~     ICU stay.~   "
160605|NCT01463865|"~     In this study the investigators wish to compare the effect of a selective axillary nerve~     block to placebo in patients undergoing arthroscopic shoulder surgery.~      It is the investigators hypothesis that the amount of morphine consumption in the first 4~     hours postoperatively in the intervention group will be significant lower than in the placebo~     group.~   "
160606|NCT01463852|"~     In this proof-of-principle study, patients with chronic lymphocytic leukemia (CLL), who are~     scheduled to initiate treatment per the recommendations of their primary oncologist, will~     receive a single dose of vincristine 2 milligrams (mg). The objective is to determine if this~     single dose will induce rapid cell death in isolated CLL cells.~      Vincristine 2 mg will be administered to the participants intravenously over 5 minutes. Blood~     samples will be collected from an intravenous line inserted into the contralateral limb to~     that where the vincristine was given, at time zero (pre-vincristine treatment), immediately~     after vincristine administration (within 2-10 minutes upon completion of administration) and~     at 1, 2, 4 and 6 hours post-vincristine treatment. Patients will then at a later date receive~     chemotherapy treatment as prescribed by their primary oncologist.~      Within 7 days of vincristine administration, participants will receive a phone call from the~     research nurse to discuss potential toxicities. At the time of the initiation of standard~     chemotherapy treatment, the Principal Investigator will also meet with the participant to~     collect information regarding adverse events.~   "
160607|NCT01463839|"~     Sleep is a vital physiological function for the maintenance of health and quality of life.~     Harmful, non-nutritive and parafunctional oral habits are believed to have a negative effect~     on adequate rest at night. The aim of the present study was to determine associations between~     quality of sleep and harmful oral habits among children aged three to six years. Fifty~     children from a private school in São Paulo (Brazil) were evaluated using two questionnaires~     on sleep quality and harmful oral habits. The data were submitted to descriptive analysis.~     The chi-square test was employed for the categorical variables and analysis of variance~     (ANOVA) was carried out to compare mean values. The Student's t-test was used for all~     analyses, with the significance level set at 5%. The SPSS 12.0 program for Windows was used~     to analyze the results.~   "
160608|NCT01463826|"~     The aim of the present study are to determine whether there is an association between~     respiratory problems and dental caries in children who exhibit the habit of bruxism.~   "
160609|NCT01463813|"~     The Finnish Vitamin D Trial (FIND) is a randomized, double-blind, placebo-controlled, 5-year~     supplementation study of the benefits and risks of vitamin D in the primary prevention of~     cardiovascular (CVD) and cancer among 18000 men 60 years or older and women 65 years or~     older.~      [Edit 25.3.2015: Due to difficulties in recruitment and funding, the study size is~     approximately 2500 subjects, with a 550 subject subgroup with more detailed examinations]~      The participants will be randomized to 3 groups with 6000 in each, with daily supplementation~     of either: 1) 40 µg/day (1600 IU) of vitamin D3, 2) 80 µg/day (3200 IU) of vitamin D3, or 3)~     placebo.~      [Edit 15.3.2015: The 2500 subjects are randomized in 3 groups, approximately 830 subjects per~     group.]~      Compliance, use of non-study drugs or supplements, diet, development of endpoints, and CVD~     and cancer risk factors will be assessed by questionnaires. Blood samples will be collected~     for assessment of effect modification by baseline 25-hydroxyvitamin D, as well as for future~     ancillary studies of genetic/biochemical hypotheses. Event data will be obtained by record~     linkage from the national computerized hospitalization registry.~   "
160610|NCT01463800|"~     Exercise intolerance is a major burden for patients with complex congenital heart disease~     (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing~     provides a reliable tool both for assessing exercise capacity of CHD patients and for risk~     stratification and is becoming part of the routine clinical assessment of these patients.~     Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise~     training has been widely studied in chronic heart failure, its efficacy in adults with CHD~     remain unknown. The investigators hypothesize that structured exercise training will improve~     exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study~     is to evaluate the impact of structured exercise training on exercise intolerance in patients~     with complex CHD.~   "
160611|NCT01463787|"~     Varicocele is the most common surgical disease which could lead to male infertility. It is~     found in approximately 15% adult males, and in about 40% infertile males. And the incidence~     is up to 80% in secondary infertility. In the past, there was continuous controversy over~     whether a varicocele repair could improve fertility. But at present, researches are coming to~     a consensus on the indication of varicocelectomy. Several researches manifest that the~     microsurgery of varicocele could have the effect of the highest spontaneous pregnancy and~     lowest complications rate after surgery. Microsurgical varicocelectomy includes two~     approaches, inguinal and subinguinal. Each one has its advantages and disadvantages. There~     are few studies which make direct comparison between the two methods in microsurgical~     varicocelectomy, especially in China. Operators have made decisions on the basis of their own~     experience and skills. In this study, the investigators compare the postoperative spontaneous~     pregnancy and complications rates in two approaches in microsurgical varicocelectomy for~     Chinese infertile men in their hospital.~   "
160612|NCT01463774|"~     The purpose of this study is to evaluate the bioequivalence of a fixed dose combination~     tablet of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of canagliflozin and metformin IR.~   "
160891|NCT01460069|"~     The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on~     psoriasis in a double-blinded, randomized placebo-controlled clinical trial.~   "
160613|NCT01463761|"~     Sports training aims to enhance an athlete's performance (overcompensation). To do that, the~     athlete must go through periods of fatigue and lower performance (overreaching). When the~     training plan is balanced, this fatigue is short and reversible.If the training load is too~     heavy or if recuperation periods are too short, it can lead to persistence fatigue that may~     only be reversible in the long term. This state of fatigue is part of the broader clinical~     picture of overtraining, which includes stark changes in performance as well as mood and~     sleep disorders. Many prediction and characterization methods based on biological markers~     have been evaluated, but they have not been put into practice in sports training due to~     obstacles such as reliability, interindividual variability and high costs. This study aims to~     evaluate a new approach based on the variability of an individual's heart rate (RR~     variability), which is a way of measuring autonomic nervous system (ASN) activity. It is~     non-invasive, low-cost, and has already proven useful in athlete health monitoring.~   "
160614|NCT01463748|"~     Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. The purposes~     of this study are going to investigate the effects of Graptopetalum paraguayense E. Walther~     on the oxidative stress, antioxidant enzyme activity and inflammation in subjects with~     metabolic syndromerelation. The investigators will recruit MS patients(n=50)and the inclusion~     criteria of MS are according to the Bureau of Health Promotion, Department of Health in~     Taiwan (2007). The MS subjects are randomly assigned to placebo(n=25) and Graptopetalum~     paraguayense E. Walther supplements(n=25)groups. Hopefully, the results of this study could~     provide the information of Graptopetalum paraguayense E. Walther supplements to what has been~     know in MS subjects.~   "
160615|NCT01463735|"~     Acanthocytes, also termed spur cell, are large erythrocytes covered with spike-like~     projections which are associated with severe hemolytic anemia. In advanced cirrhosis,~     acanthocytes may account for 20 to 30% of red blood cells. Up to 70% of cirrhotic patients~     display anemia and hemoglobin level may fall to below 5 gr/L in spur cell anemia. The true~     incidence of spur cells in cirrhosis is not known precisely but may avoisinate 45%, typically~     in patients with advanced cirrhosis.The presence of spur cells usually predicts lower~     survival rates. Vitamin E is an antioxidant compound that is a component of biological~     membrane that helps to maintain integrity of lipid bilayers. Vitamin E deficiency leads to~     erythrocyte hemolysis, which is improved by supplemental vitamin E. This study is an open~     label single arm phase II study in cirrhotic patients treated for 4 weeks with Tocofersolan~     (Vedrop), a water-soluble derivative of alpha-tocopherol, and thus an orally bio-available~     source of vitamin E. The aim of this study is to determine the effect of tocofersolan on red~     blood cell membranes lipid composition in adult patients with cirrhosis and vitamin E~     deficiency. Secondary endpoints are the effects of tocofersolan on anemia, hemolysis and~     acanthocytosis; on lipid peroxidation and oxidative stress; the safety of a 4 week treatment~     of 700 mg/day.~   "
160616|NCT01463722|"~     The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body~     Counting for Evaluating of Fetal Lung Maturity.~   "
160617|NCT01463709|"~     Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed~     electric fields (nsPEF)~   "
160618|NCT01463696|"~     This study is being done to evaluate the safety and pharmacokinetic profile of MK-8242 and~     its active metabolite (M16) in participants with advanced solid tumors. In Part 1 of the~     study, the study drug dose will be escalated to determine the maximum tolerated dose (MTD).~     In Part 2 of the study, the MTD will be confirmed and the recommended Phase 2 dose (RPTD)~     established; the effect of MK-8242 on liposarcoma and other tumor types will also be~     evaluated.~   "
160619|NCT01463683|"~     This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II~     compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.~   "
160620|NCT01463670|"~     The purpose of this study is to determine whether this disease will get better if treated~     with higher doses of Lenalidomide even if the disease returns while taking low doses of~     Lenalidomide. In patients with multiple myeloma treated with Lenalidomide maintenance, the~     disease will return. However, the physician currently does not know if the disease would~     respond to treatment with higher doses of Lenalidomide. This is very important for patients~     with multiple myeloma because the number of drugs available to treat the disease are limited.~     It is important to know if Lenalidomide remains still effective and if it can still be used~     in this situation. This study will try to find out what effects, good and/or bad higher doses~     of Lenalidomide has on the patient and the disease after it has returned.~   "
160621|NCT01463657|"~     Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will~     be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial~     fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.~   "
160622|NCT01463644|"~     Some patients with chronic obstructive pulmonary diseases (COPD) have large number of~     specific white blood cells called eosinophils in their airways. These cells are also~     responsible for causing episodes of worsened respiratory symptoms (exacerbations) and often~     cause irreversible damage to the airways . This subset of COPD patients often require oral~     steroids to bring down the number of eosinophils in their airways. Steroids have harmful~     effects on several of our body systems like bones, blood pressure, blood glucose control and~     can cause recurrent infections. Mepolizumab is a drug that specifically targets eosinophils~     reducing the number in the airway. This drug has been shown to be effective in decreasing~     exacerbation rates and time to exacerbation in asthma patients with eosinophils in their~     airways. Targeting eosinophils in COPD patients has been shown to reduce severe~     exacerbations. Hence it is likely that COPD patients with eosinophils in their airways will~     benefit similarly and have reduced rates and time to exacerbation.~      Study Hypothesis:Does mepolizumab decrease sputum eosinophils in patients with fixed airflow~     obstruction (COPD) and eosinophilic bronchitis?~   "
160623|NCT01463631|"~     This study evaluates the safety and tolerability of different doses of an experimental~     treatment in participants with advanced cancer.~   "
160710|NCT01462474|"~     RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3,~     Flt1 and Flt3. Phase I study of mono famitinib has shown that the drug's toxicity is~     manageable.~      PURPOSE: This phase I trial is studying the safety and tolerance of concurrent~     chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.~   "
160624|NCT01463605|"~     For patients who are unable to receive surgery or having local advanced esophageal cancer~     stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy~     for older patients because of their chemoradiotherapy intolerance. The whole world focused on~     targeted therapy which has strong specialties and mild toxicities. So combined targeted~     therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer.~     Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and~     safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal~     cancer. All patients receive intensity modulated radiotherapy with conventional fraction.~     Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.~   "
160625|NCT01463592|"~     Chronic HCV infection is one of the common causes of the chronic liver disease. Approximately~     6-10% of the general public is expected to be suffering from this infection. In case that~     these patients are not treated at an appropriate time, these patients develop the sequelae of~     the chronic liver disease e.g. cirrhosis of liver, Ascites, and Hepatocellular carinoma.~     Interferon alpha 2 a or alpha 2b injections and Ribavirin combination is the treatment of~     choice for people suffering from Chronic HCV infection and this combination need to be~     administered for 6-12 months. Interferons are biological agents and are to be administered~     parenterally. Interferons are expensive and are associated with number of minor and major~     adverse effects. Ribavirin is also associated with significant adverse effects. These~     compounds cannot be considered as one of the ideal forms of the treatment.~      In the past, quite a few natural products have been tested to assess their hepatoprotective~     activity and possibly anti viral activity as well. These include Vitamin C (Ascorbic acid),~     Vitamin E, Zinc, Silymarin, Red beet roots, crushed licorice and etc. etc.~      Rationale Iodine , Potassium iodide and Ascorbic acid are natural products used in the~     management of Thyroiditis and chronic cutaneous fungal infections. This combination of iodine~     compounds along with ascorbic acid is being used for the management of chronic hepatitis B &~     C in the central Asian states e.g. Kazakhstan etc.~      The investigators have conducted a feasibility study in which oral Iodine Compound~     {RENESSANS} was given to patients suffering HCV related Chronic Active Hepatitis and~     anti-viral activity and safety has been analyzed. In this study, RENESSANS containing regimen~     has been well tolerated by all the patients and has shown some antiviral activity.~      In this study the investigators will assess whether the administration of RENESSANS {oral }~     improves the antiviral activity in patients receiving standard interferon therapy.~   "
160626|NCT01463579|"~     The purpose of this study is to test if a 6-week programme of exercise improves physical~     function and health related quality of life in patients following intensive care who are~     discharged from hospital. In this study the investigators will compare the physical function~     and health related quality of life of patients who attend the programme with patients who do~     not. The 6 week exercise programme will be run by physiotherapy staff, and will mostly take~     place in a hospital gym. The investigators will measure patients' physical function, exercise~     capacity, level of breathlessness and their quality of life before and after the 6-week~     programme, and 6 months later. The investigators will also interview patients to ask their~     views about the acceptability, enjoyment and satisfaction with the exercise programme. If~     this study shows that the physical function and health related quality of life are improved~     in those who took part in the exercise programme, then it will provide useful information~     which will help the development of services for patients after critical illness. The results~     will also provide information which will help us design future clinical trials for this~     patient population.~   "
160627|NCT01463566|"~     This is a prospective multicenter study of the Gender Solutions Natural Knee Flex System when~     used in primary total knee arthroplasty. The purpose of the study is to obtain short-, Mid-,~     and long-term clinical outcomes and implant survivorship data for the Gender Solutions~     Natural Knee Flex System.~   "
160628|NCT01463553|"~     The purpose of this study is to:~        1. Evaluate the validity of using abnormal characteristics of the pneumothorax line, as~          evaluated from chest X-ray film, as the operative indications for video-assisted~          thoracic surgery (VATS) on primary spontaneous pneumothorax (PSP).~        2. Through a randomized double blind controlled trial on patients whose PSP was caused by~          lung bullae, evaluate the effectiveness of pleurodesis in terms of the rate of~          recurrence of PSP and the trauma of the operation on patients.~        3. Based on the findings, establish selection standards for the timing of surgery to treat~          PSP by VATS and establish technical specifications for performing operations on~          different types of lung bullae. The goal is to improve the diagnosis and treatment of~          PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation,~          shorten hospital stays and postoperative recovery time, and provide better services for~          returning to everyday life and improving the quality of life for patients.~   "
160629|NCT01463540|"~     Endoscopic placement of a percutaneous gastrostomy tube is a safe, efficient and well~     standardized technique. Two variants of this maneuver - the pull and the push techniques -~     are widespread worldwide. More recently different techniques, that allow the direct insertion~     of a gastrostomy tube has been described. The common characteristic shared by all these~     technique is the fact that the gastrostomy tube is inserted directly into the stomach~     (without passing through the pharynx), after the gastric and abdominal wall have been~     securely fasten together (gastropexy).~      Advantage of direct techniques are the followings:~        1. the tube can placed also in the case of an oesophageal stenosis~        2. studies suggest that the peristomal wound infection are less frequent using direct~          techniques~        3. in some variants of these techniques, a balloon type gastrostomy tube or a button can be~          placed also in the case of first positioning. Both the balloon type tube and the button~          are easy to be changed also at the bed-side.~      Drawbacks of the direct techniques are:~        1. these technique are easy, but a little more cumbersome than classic push or pull~          maneuvers~        2. operators are often not familiar with direct insertion~        3. kits suited for direct insertion are generally more costly than available kits for push~          or pull placement of gastrostomy tube.~      The kit manufactured by the Kimberly-Clark (MIC Introducer kit) allows direct insertion of a~     balloon type gastrostomy tube or of a button and it is interesting, because it makes simple~     to perform the gastropexy.~      The study aim is to confirm that the use of the Kit Introducer MIC, may allow safe placement~     of a gastrostomy tube and may reduce the incidence of peristomal wound infection. Furthermore~     if a balloon type gastrostomy tube or a button are positioned, they may be changed at the~     bed-side, without referral of the patient to the endoscopic unit or to an other sanitary~     facility.~   "
160630|NCT01463527|"~     The investigators hypothesize that the addition of capnography during moderate sedation will~     improve recognition of hypoventilation and apnea. This will lead to an increased frequency of~     staff interventions such as verbal or physical stimulation for these events in order to~     improve ventilation which will in turn lead to a reduction in the frequency of oxygen~     desaturations. If capnography proves to be effective in creating earlier detection and~     intervention for hypoventilation and apnea during moderate sedation provided by~     non-anesthesiologists, this device can be used in a variety of clinical settings to enhance~     patient safety.~   "
160711|NCT01462461|"~     The purpose of this study is to determine if observing a virtual arm decreases phantom limb~     pain (PLP) in upper extremity amputees.~   "
160712|NCT01462448|"~     The purpose of this study is to determine if there is a genetic component to phantom limb~     pain. DNA will be analyzed for single nucleotide polymorphisms (SNPs) between the control and~     phantom limb pain group. Total RNA will also be isolated and profiled to asses the degree to~     which our gene(s) of interest are expressed in the presence or absence of phantom limb pain.~     Some proteins, such as inflammatory antibodies or the neurotrophin brain-derived neurotrophic~     factor (BDNF), will also be assessed for their association(s) with phantom limb pain.~   "
160631|NCT01463514|"~     To study the effect of acute pulmonary vasodilatation on cerebral tissue oxygenation (CTO)~     and cerebral blood flow (CBF) as indicator for cerebrovascular autoregulation in comparison~     to the effects of supplemental oxygen, decreased carbon dioxide by hyperventilation and~     exercise in patients with pulmonary hypertension (PH) undergoing clinically indicated right~     heart catheterisation (RHC).~      Oxygenation and hemodynamic parameters will be assessed during RHC according to standard~     procedures. Non-invasive near infrared spectroscopy (NIRS) and a nasal canula will be~     additionally applied to measure CTO, CBF and endtidal CO2 (EtCO2). All parameters will be~     obtained at rest breathing room air, during an oxygen challenge, during standardized~     hyperventilation, under vasodilatation testing and during exercise in random, single-blinded~     sequences (except for exercise and hyperventilation). Pulmonary, systemic and cerebral~     oxygenation parameters and hemodynamics will be correlated with each other and functional~     class, quality of life, exercise and cognitive assessments at the time of the RHC and after~     three month.~   "
160632|NCT01463501|"~     This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy~     (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative~     Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.~   "
160633|NCT01463488|"~     Study objectives:~        -  Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety,~          tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.~        -  Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and~          tolerability of a single intra-articular dose of SAR113945.~   "
160634|NCT01463475|"~     The objective of this protocol is to use established standard criteria and methods for the~     collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The~     hMSC collected from the donors will use to develop well-defined and reproducible cell banks.~     Standard manufacturing procedures and quality control testing methods will be used to~     characterize and evaluate the final cell product. After the cell banks are created, these~     cell products will be used in future translational or clinical research.~   "
160635|NCT01463462|"~     This is an observational, exploratory study designed to collect (record) and analyze normal~     and abnormal sound data from the human bladder during surgery using a novel sensor-based~     catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes~     of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will~     measure acoustic and pressure data within the bladder. The measurements will be used to~     detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation~     of sound data with surgical data reported by the surgeon. These data will be used to develop~     algorithms to detect changes of baseline bladder and ureteral function. The algorithms will~     be tested in future clinical trials.~   "
160636|NCT01463449|"~     CD163 is a membrane bound receptor primary expressed in monocytes and macrophages. A soluble~     variant of CD163 (sCD163) is present in plasma and is elevated in pathological condition~     activating the monocyte-macrophage system. Recently sCD163 is associated with various~     inflammatory conditions, ex. adipose tissue inflammation and very recently to be a rather~     strong predictor of the development of type 2-diabetes. Only a subset of obese individuals~     develops insulin resistance, type 2-diabetes and related diseases. These healthy obese~     subjects are characterized of less adipose tissue inflammation and less insulin resistance as~     compared to unhealthy obese individuals. Consequently it would be of great importance to~     develop markers that could discriminate between healthy and unhealthy obese subjects. Aim: To~     investigate whether macrophage CD163 is involved in adipose tissue inflammation in obesity~     and thereby to the metabolic complications of metabolic syndrome. To investigate how sCD163~     is regulated by metabolic factors such as obesity, fat distribution, weight loss and diet.~     Methods: Intervention study. 45 morbidly obese subject approved to gastric by-pass. Blood~     samples, MR-spectroscopy, DXA, weight control and fat biopsy are taken before and 12 month~     after surgery. Correlations studies: to investigate the influence of diet and weight loss on~     CD163 and sCD163. Perspective: To study the role of macrophages infiltration and activation~     for adipose tissue inflammation and to determine whether the macrophage marker, s-CD163,~     together with other markers will be able better to identify obese individuals who are at~     increased risk for developing complications such as diabetes~   "
160637|NCT01463436|"~     A randomized double blind controlled trial was conducted to evaluate the effect of daily~     supplementation with soy isoflavone 100 mg/day for 12 months on 182 postmenopausal women aged~     47 to 60 years at subdistrict South Jakarta Indonesia. The study hypothesis was~     supplementation soy isoflavone 100 mg/day for 6 and 12 months can increase endothelial~     function.~   "
160638|NCT01463423|"~     A research study using a method of treating lung cancer with focused radiation called~     Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the~     effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR~     based on tumor-specific factors.~   "
160639|NCT01463410|"~     This clinical study will demonstrate the accuracy of the chromosomal aberration and gene~     mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical~     performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug~     Administration for in vitro diagnostic use within the United States of America.~      The objective is to demonstrate the positive and negative percent agreement of each marker by~     comparing AMLProfiler results from multiple clinical participating sites with data generated~     using a laboratory developed bi-directional sequencing method generated at the molecular~     diagnostic reference lab.~      The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or~     APL specific chromosomal aberrations (specific recurrent translocations and inversions), as~     well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of~     patients with Acute Myeloid Leukemia.~   "
160713|NCT01462435|"~     The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and~     effective for the treatment of bunionectomy pain.~   "
160817|NCT01461044|"~     This observational study will evaluate the safety and efficacy of triple negative or HR+~     patients with HER2-metastatic or locally advanced breast cancer treated with Avastin~     (bevacizumab) as first line therapy for at least 12 months and without disease progression~     for at least 12 months. Data will be collected retrospectively (from the diagnosis to the~     inclusion in the study) and for 18 months from study start.~   "
160640|NCT01463397|"~     Primary Objective:~      To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with~     chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS).~      Secondary Objectives:~        -  To compare the effects of SAR292833 with placebo on the change of neuropathic pain~          symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI);~        -  To evaluate the effects of SAR292833 in comparison to placebo on the change in pain~          intensity of mechanical allodynia;~        -  To investigate the safety and tolerability of SAR292833 in comparison to placebo;~        -  To investigate the pharmacokinetics (PK) and the relationships between main efficacy~          parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in~          patients with chronic peripheral neuropathic pain.~   "
160641|NCT01463384|"~     Cognitively normal individuals, patients with Mild Cognitive Impairment (MCI) or Alzheimer's~     Disease (AD) will undergo clinical screening, neuropsychological tests, blood and urine~     analyses, quantitative magnetic resonance imaging (MRI) and proton (1H ) and carbon 13 (13C)~     magnetic resonance spectroscopy (MRS). Each individual will receive minocycline oral~     administration for 4 weeks initially, after which MRI, MRS and neuropsychological results~     will be recorded. If no adverse side effects occur, subjects will continue minocycline~     administration for an additional 5 months.~   "
160642|NCT01463371|"~     The mechanism by which macrolide antibiotics have immune modifying effects independent from~     its antibacterial activity has not been well established. In the present work, the~     investigators will analyze the effect of long-term treatment with azithromycin (250 mg three~     times per week during three months) on airway oxidative stress markers in exhaled breath~     condensate of adult patients with stable non-CF bronchiectasis.~   "
160643|NCT01463358|"~     Study Objective~      The purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to~     patient symptoms in patients with bifascicular block and syncope of unexplained origin.~   "
160644|NCT01463345|"~     The objective of the study is to examine the safety of two different hemoglobin (Hgb)-based~     transfusion triggers in patients post cardiac surgery.~   "
160645|NCT01463332|"~     Propofol is commonly used IV anesthetic, it has been formulated in a concentration of 10~     mg/ml in a fat emulsion consisting of 10% soybean oil (long-chain triglycerides). When used~     for anesthetic induction, propofol causes pain on injection in 28%-90% of patients. pain~     probably results from a direct irritant effect. Several methods have been used to reduce this~     pain. Lidocaine pretreatment has been commonly proposed to decrease propofol induced pain,~     but its failure rate is between 13-32%. Dexmedetomidine is highly selective alfa-2~     adrenoreceptor agonist. Alpha-2 receptors are located on blood vessels where they inhibit~     norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could~     attenuate the pain due to injection of propofol. Investigators conducted a study to determine~     the efficacy of dexmedetomidine in decreasing pain due to injection of propofol.~   "
160646|NCT01463319|"~     Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no~     incidence of drug-related side effects. May be slightly painful or discomforting for the~     patient. Based on numerous recent reports, the investigators designed this randomized~     controlled trial hypothesizing that the use of warm water irrigation versus air insufflation~     during the insertion phase of colonoscopy might increase the global tolerability of the~     examination and the proportion of patients undergoing complete colonoscopy without sedation~     or with a low dose of sedatives.~   "
160647|NCT01463306|"~     Study A0081106 is a 12-month open-label study to evaluate the long term safety and~     tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age~     with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with~     primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided~     daily doses for 1 year, in either capsule or liquid oral formulation.~   "
160648|NCT01463293|"~     This study will investigate the effects of 4-week probiotic supplementation on whole gut~     transit time and gastrointestinal symptoms in adults with functional constipation.~   "
160649|NCT01463280|"~     The purpose of this study is to evaluate the effect of lidocaine, delivered into subcutaneous~     tissue for tumescent local anesthesia, on platelet activation following the tumescent~     liposuction.~   "
160650|NCT01463267|"~     This study is being done to look at how people manage their heart failure. The investigators~     are testing two medication reminder systems and the investigators want to know which one~     people like better. The investigators also want to see if they have any effect on ease of~     managing medication in individuals with heart failure.~   "
160651|NCT01463254|"~     This will be a non-comparative prospective observational study of women using Femplant as a~     primary method of contraception in Pakistan.~   "
160652|NCT01463241|"~     The overall objective of the project is to develop and assess the feasibility of a brief,~     practice-friendly approach to psychotherapy for children, entitled Behavioral and Affective~     Skills in Coping (BASIC) and designed for use as a first step toward evidence-based practice~     by practitioners in clinical service settings.~   "
160653|NCT01463228|"~     The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC)~     tablet of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of canagliflozin and metformin IR.~   "
160654|NCT01463215|"~     Ambroxol is expected to improve the signs and symptoms of patients with Type I Gaucher~     Disease.~   "
160655|NCT01463202|"~     The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after~     delivery to find out whether the timing of postpartum administration of DMPA (prior to~     hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of~     breastfeeding among women who plan to breastfeed their infants.~   "
160656|NCT01463189|"~     Development of an interactive, online pain self-management program for adults who suffer from~     pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other~     arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive~     Theory (Bandura, 1977). This online health intervention, painACTION: Arthritis, will provide~     clinically reliable information about diagnosis, treatment, and management of arthritis,~     written for health consumers in a clear and engaging manner to help increase their skills and~     confidence to use self-management strategies.~   "
160818|NCT01461031|"~     The aim of this study is to determine the analgesic effect of perioperative nefopam on acute~     pain in patient undergoing orthognathic surgery.~   "
160657|NCT01463176|"~     Many young children undergo medical procedures that are painful and distressing. Negative~     experiences during medical procedures can have serious long-term effects, including fear and~     avoidance of medical procedures during adulthood. Distraction interventions can help prevent~     children from forming negative memories of medical procedures. Live music therapy has been~     shown to alleviate pediatric distress during both invasive and non-invasive procedures. The~     objective of this study is to examine the effects of music therapy on the child's distress~     behaviors and time to calm, as well as the length of the procedure and use of restraint, and~     parents' and healthcare staffs' behaviors during the procedure, for young children undergoing~     immunizations and influenza vaccinations. It is hypothesized that children receiving music~     therapy will show fewer distress behaviors, calm more quickly, and have shorter procedures~     with fewer instances of restraint compared to children who receive standard care. In~     addition, it is predicted that adults (parents and staff) will show fewer distress-promoting~     behaviors during, before, and after the procedures.~   "
160658|NCT01463163|"~     This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic~     study with a parallel design. Patients with ST elevation myocardial infarction, undergoing~     primary percutaneous coronary intervention will be randomized after informed consent, in a~     1:1 ratio to the following treatment groups:~      Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose~     (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel~     60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after~     randomization).~      Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24~     hours after randomization, and on Day 5. Documentation of major adverse cardiac events~     (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and~     serious adverse events (bleeding, other adverse events)will be performed until Day 5.~   "
160659|NCT01463150|"~     The use of dual antiplatelet therapy is considered standard of care in patients post~     percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of~     patients is considered clopidogrel resistant and this resistance is shown to be accompanied~     by future adverse events. The aim of the study is to define in consecutive patients with~     acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with~     high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24~     hours post PCI with the VerifyNow assay. Those patients will be randomized after informed~     concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will~     be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet~     reactivity will be determined as well.~   "
160660|NCT01463137|"~     A study investigating six different versions of a computerized attention bias modification~     internet program in the treatment of social phobia / social anxiety disorder.~   "
160661|NCT01463124|"~     Adolescent overweight and obesity have increased dramatically in the past several decades.~     High schools are well-positioned to deliver weight loss treatment to overweight and obese~     adolescents, as they have the facilities and staff to deliver a physical activity program,~     school nurses with the skills to provide counseling, and are easily accessible by~     adolescents. This exploratory study will test the feasibility and ability of a school-based~     intervention, consisting of school nurse counseling and a school-based exercise program, to~     reduce BMI and improve dietary quality, physical activity, and sedentary behaviors in~     overweight and obese adolescents. If effective, this could prove to be a cost-effective and~     relatively easy intervention to disseminate widely for significant public health impact.~   "
160662|NCT01463111|"~     Forty subjects with bipolar disorder who are not receiving a mood-stabilizing medication for~     the treatment of their illness will participate in this study. The study aims to evaluate how~     decision-making is affected by treatment for bipolar disorder. Prior to beginning treatment,~     patients will complete questionnaires and a one-hour computer-administered assessment of~     decision-making. Differences between pre-post decision-making outcomes will be evaluated to~     examine whether the neuroeconomic concepts of risk aversion, loss aversion, risk tolerance~     and delay discounting are affected by treatment.~      The overall goal of this study will be to identify whether decision-making in people with~     bipolar disorder is affected by treatment. Specifically the investigators will compare~     decision-making characteristics among bipolar patients prior to treatment with how these~     decision-making characteristics change over the course of 6 weeks of standard medication~     therapy for bipolar disorder. A total of 6 decision-making tasks and one control task will be~     administered via computer to eligible subjects. The investigators will evaluate~     decision-making under varying conditions of reward, risk, and uncertainty and over time. The~     investigators hypothesize that decision-making will improve across these assessments after 6~     weeks of treatment.~   "
160663|NCT01463098|"~     Part A: The purpose of this study is to evaluate the safety and tolerability of single oral~     doses of E2006 administered in the morning to healthy male and female subjects.~      Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters~     (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects~     with primary insomnia following single oral dosing of E2006 in the evening approximately 30~     minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.~   "
160664|NCT01463085|"~     The purpose of this study is to determine if increased consumption of low-fat dairy can~     reduce blood pressure and improve endothelial function in men and women with pre or stage-1~     hypertension.~   "
160665|NCT01463072|"~     This phase II trial studies the side effects of paclitaxel albumin-stabilized nanoparticle~     formulation in treating older patients with breast cancer that has spread from where it~     started to nearby tissue or lymph nodes (locally advanced) or other places in the body~     (metastatic). Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing, or by stopping them from spreading.~   "
160666|NCT01463059|"~     The primary objective of this study is to evaluate the efficacy and safety of CDP6038~     administered subcutaneous (sc) at various doses compared to placebo.~   "
160667|NCT01463046|"~     The purpose of this study is to see if Panobinostat is safe to give to patients and to~     determine the best dose to give in combination with standard cytarabine and daunorubicin~     chemotherapy.~   "
160668|NCT01463033|"~     Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at~     preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful.~     Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of~     epilepsy. It has a favorable side effect and pharmacokinetic profile. It is therefore a~     strong candidate for a clinical trial of epilepsy prevention following traumatic brain injury~     (TBI). However, there has been no experience in administering levetiracetam rapidly to~     individuals with acute TBI. The investigators propose to initiate the evaluation of~     levetiracetam in prevention of post-traumatic epilepsy by determining the safety,~     tolerability, pharmacokinetics and feasibility of acute and chronic administration of~     levetiracetam to individuals with head injury with a high risk for developing post-traumatic~     epilepsy. Further, the investigators will follow subjects for 2 years after injury in order~     to obtain pilot data about effect of levetiracetam on PTE. This pilot study is the first step~     in evaluation of levetiracetam in prevention of post-traumatic epilepsy.~   "
160669|NCT01463020|"~     The objective is to test the effects of a smartphone-delivered behavioural activation~     treatment. Also, a moderator analysis of low and high severity of depressive symptoms will be~     made. We expect the behavioural activation intervention to be superior to the mindfulness~     intervention for the participants suffering from high severity of depressive symptoms - and~     the mindfulness intervention to be better or at least as good as the behavioural activation~     intervention for the participants suffering from low severity of depressive symptoms.~   "
160670|NCT01463007|"~     The purpose of this study is to evaluate the rate of early and intermediate toxicity related~     to the AccuBoost System for delivery of APBI in women with resected, early stage breast~     cancer.~   "
160671|NCT01462994|"~     Activating mutations of the kinases CKIT or PDGFRA can be detected in 90% of cases by DNA~     sequence analysis of a pathological specimen. These mutated genomic DNA fragments are highly~     specific for the tumor and are released by the tumor into the circulation. Allele-specific~     PCR can be used to specifically amplify and quantify mutated CKIT and PDGFR DNA fragments.~      The current trial aims to evaluate whether tumor DNA carrying mutations for CKIT and PDGFRA~     can be detected and quantified in the plasma of patients with active GIST, and whether~     detection can be correlated with the clinical course of disease either under therapy or in~     progressive disease irrespective of current therapy.~   "
160672|NCT01462981|"~     Hepatitis B is a form of liver disease caused by a DNA-virus, called hepatitis B virus (HBV).~     Infection can result in an inflammation of the liver parenchyma with various clinical~     manifestations ranging from an asymptomatic course to jaundice. After contact with the virus~     the immunological response of the host determines the clinical outcome leading to either~     viral clearance or a chronic infection.~      Although several factors are responsible for the development of chronic HBV-infection, one of~     the factors is a weak and transient CD8+ T-cell responses after HBV infection. In chronic~     hepatitis B, inflammation can lead to scarring which is the driving force to fibrosis and~     cirrhosis. Some immunological parameters, like a newly discovered subset of IL-17 producing T~     helper cells (Th17 cells), may influence the disease progression of HBV. In the cirrhotic~     patient, eventually there is an increased risk of hepatocellular carcinoma (HCC) leading to~     liver failure.~      Recent literature in Asian patients with chronic hepatitis B showed that serum HBV viral load~     is a strong predictor for the development of cirrhosis, independent of hepatitis B e- antigen~     status and serum alanine transaminase level. It is unclear whether these results can be~     extrapolated to non-Asian (Caucasian and African) populations because of differences in host~     (HLA background) and viral (HBV genotype) factors.~      The aim of this study is to elucidate the question whether historic HBV viral load is~     associated with the risk of HBV-related cirrhosis or mortality in a cohort of non-Asian~     individuals with chronic hepatitis B infection.~   "
160673|NCT01462968|"~     The purpose of this study is to find the heparinization method, which~        1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis~        2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared~          to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac~          surgery.~      The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in~     the Hepcon-group because of the heparinization-method. Therefore there is a potential higher~     risk for use of bloodproducts postoperatively.~   "
160674|NCT01462942|"~     The objective is to provide data supporting the use of LAS40464 as an efficacious and safe~     maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease~     (COPD).~   "
160675|NCT01462929|"~     The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled~     aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide,~     respectively, after 6 weeks of treatment.~   "
160676|NCT01462916|"~     Based on the assumption that honey may have an immunomodulatory effect, the aim of our~     present study will be to verify whether the intake of honey, as a natural substance, in~     patients with chronic Immune Thrombocytopenia (ITP) could affect the platelet number and~     hence could affect the bleeding severity. Thirty patients suffering from chronic ITP will be~     recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University,~     Cairo, Egypt. The diagnosis of ITP will be based on the presence of isolated thrombocytopenia~     with a peripheral blood platelet count less than 100 x 109/L, and absence of any obvious~     initiating and/or underlying cause of the thrombocytopenia. Chronic ITP is defined as ITP for~     at least 12 months. The age of the patients will range from 5 to 15 years, and they will be~     of both sexes. This study was approved by the local Ethics Committee of the Pediatric~     Department of Ain Shams University, and an informed consent to participate in this study will~     be obtained from at least one parent of each patient. Furthermore, an ascent form will be~     obtained from each patient above 7 years of age.~   "
160677|NCT01462903|"~     Background: T cell based adoptive immunotherapy including CTL and TIL may stimulated the~     immune system and stop cancer cells from growing.~      Objective: Phase I clinical trial to investigate the toxicity and immune response of therapy~     with autologous tumor infiltrating lymphocytes as adjuvant treatment for metastatic~     nasopharyngeal carcinoma and hepatocellular carcinoma after primary operation, radiotherapy~     and chemotherapy.~      Methodology: Phase I clinical trial in patients with advanced nasopharyngeal carcinoma,~     hepatocellular carcinoma, breast cancer and other solid cancers. The investigators isolated~     lymphocytes from fresh tumor tissues, activated and expanded TILs in vitro; and infused the~     enough number (10e9 to 10e10) of TIL back patients.~   "
160680|NCT01462864|"~     Polycystic Ovary syndrome (PCOS) is a common hormonal imbalance affecting about 12% of women~     in the UK. The number of women with PCOS is rising. They suffer from a combination of~     symptoms including excess hair, irregular/absent periods, and infertility. About 70% of women~     with PCOS are obese or overweight, 10% develop type 2 diabetes (T2DM), and 30-40% have some~     degrees of abnormality in controlling (metabolising) blood sugar. Studies have shown that if~     women with PCOS make change to their lifestyle (diet and activity), they may reduce their~     risk of getting diabetes and heart disease in the future. This study aims to develop and test~     a programme that can be run in groups (structured education), to support women with PCOS make~     the lifestyle changes needed to improve their PCOS and prevent future associated health~     problems. Structured education programmes are suitable for use within the NHS and are already~     recommended for individuals with T2DM, but have not been tested as a method of treatment for~     PCOS which is a high risk condition for T2DM.~      The investigators aim to initially develop a specific education programme for women with PCOS~     using their expertise in their disease and defining their needs. The next step is to test~     this programme on 160 women with PCOS who will be selected from the investigators database or~     clinics. They will be divided randomly to two groups to receive either this programme or~     routine care.~      The investigators will give them an accelerometer (a very small portable device). This will~     measure their physical activity and counts their daily steps. The investigators aim is to~     increase their step count by at least 2000 steps per day after one year.~      The investigators believe that the group given the structured education will show some~     evidence of improvement in their glucose metabolism, and consequently decreased chance of~     developing diabetes.~   "
160681|NCT01462851|"~     This study is designed to observe the safety and concentrations of PF-05297909 and proteins~     in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.~   "
160682|NCT01462838|"~     Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16_37-63~     in combination with Montanide® ISA-51 VG so that an immune response directed against the~     tumor cells can be induced. The aim is to show that vaccination with P16_37-63 is safe and~     can induce or enhance immune responses against p16INK4a.~   "
160683|NCT01462825|"~     The purpose of this study is to determine the inhibiting effects of a single consumption of~     tomato ketchup on inflammation which will be induced ex-vivo in human blood.~   "
160684|NCT01462812|"~     The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through~     the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated~     with migraine headaches.~   "
160685|NCT01462799|"~     The hypothesis is that problem based learning (PBL) in patient education positively affects~     self-care agency of lifestyle changes after an event of coronary heart disease (CHD). The~     investigators therefore aim to determine whether long-term follow-up in primary health care~     in patient education involving PBL affects self-care behaviour in terms of patients' beliefs,~     self-efficacy and empowerment to make lifestyle changes. The general aim is to evaluate if~     PBL in patient education after CHD affects long-term self-care in relation to present~     lifestyle goals. Another aim of the study is to perform an economic assessment of long term~     effects of life style changes reached by using PBL after en event of CHD.~   "
160686|NCT01462786|"~     The objectives of this trial are to evaluate the safety and tolerability of ATX-101~     injections and to compare the pharmacokinetic profile of ATX-101 administered into~     subcutaneous fat in the submental area and abdomen.~   "
160687|NCT01462773|"~     The purpose of this study is to determine the safety, tolerability and dose limiting~     toxicities (DLTs) of VELCADE when administered in combination with interferon-alpha-2b~     (IFN-α-2b) to patients with metastatic malignant melanoma.~   "
160688|NCT01462760|"~     In this study, the investigators will measure range of motion of the elbow in a geriatric~     assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph~     and the software analysis BioVal. This technique will be compared with the standard technique~     (inclinometer). It will also be evaluated during this study, the ease of use and feedback.~   "
160689|NCT01462747|"~     The aim of this study is to evaluate the effects of rectally administered activated carbon~     (medical device KULIST) in chronic, uncomplicated, perianal fistulas.~   "
160690|NCT01462734|"~     MicroRNAs are important regulators of many cellular functions but their expression profile in~     human vitreous is still unclear. Aim of this study is to investigate microRNA expression~     profile by PCR in human vitreous of macula hole patients which is suggested to be similar to~     that of healthy patients.~   "
160691|NCT01462721|"~     The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support~     (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.~   "
160692|NCT01462708|"~     The purpose of this study is to assess MK-9470 Positron Emission Tomography (PET) imaging as~     a tool to evaluate the activity of the CB-1 receptor in the brain.~   "
160693|NCT01462695|"~     This phase II trial studies how well sunitinib malate works in treating younger patients with~     recurrent, refractory, or progressive malignant glioma or ependymoma. Sunitinib malate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
160694|NCT01462682|"~     The aim of this study was to illustrate surgeons' own perception of fatigue and the impact~     they felt it had on their performance. This was accomplished through a focus group study,~     where 13 surgeons participated.~   "
160695|NCT01462669|"~     The purpose of this study is to investigate the pharmacokinetics of single oral doses of~     ezogabine/retigabine and the primary metabolite (NAMR) in healthy male and female Taiwanese~     volunteers. Subjects will receive four separate doses of ezogabine/retigabine tablets: 50 mg,~     100 mg, 200 mg and 400 mg administered once orally. Blood samples will be obtained at~     pre-defined timepoints over the duration of the study to determine the concentration of~     ezogabine/retigabine and NAMR. Safety assessments will include measurements of vital signs,~     collection of adverse events, clinical laboratory tests and the Columbia Suicide Severity~     Rating Scale.~   "
160714|NCT01462422|"~     This study compares two community-level strategies: selective administration of 800 mcg~     sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum~     hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for~     primary prevention of PPH. The study hypothesizes that at community-level births, secondary~     prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis~     provided to women for primary prevention of PPH. This cluster-design non-inferiority trial~     has the potential to inform service delivery programs on clinical outcomes, program~     feasibility, cost and acceptability of two different community models of PPH care using~     misoprostol.~   "
160819|NCT01461018|"~     The purpose of this study is to assess the long-term efficacy, tolerability, and safety of~     IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding~     follow-up study ZLB07_001CR (NCT01458171).~   "
160696|NCT01462656|"~     A prospective cohort study of antiepileptic drug (AED) polytherapy-treated epilepsy patients~     within the HealthCore Integrated Research Database (HIRD) will be conducted. Following the~     launch of Ezogabine (EZG), patients initiating a new AED polytherapy regimen will be followed~     until the earliest of an episode of urinary retention (UR), change in their AED regimen, end~     of follow-up, or end of study (when the specified sample size of EZG AED polytherapy users~     has been attained). After the end of study, the incidence of UR during exposures to EZG and~     non-EZG AED polytherapies will be compared. Polytherapy will be defined as treatment regimen~     containing at least two different AEDs.~      A prospective cohort study of patients who receive EZG under circumstances not indicated in~     the product label within the HIRD will also be conducted. Following the launch of EZG,~     epilepsy patients initiating AED monotherapy with EZG as well as non-epilepsy patients~     initiating EZG for another disease will be followed until the earliest of an episode of UR,~     change in their AED regimen (if applicable), end of follow-up, or end of study. The incidence~     of UR during exposure to EZG under circumstances not indicated in the product label will be~     described. A descriptive analysis of the patients will also be included.~      To meet the other secondary objective, non-EZG AED monotherapy users will be identified in~     the prospective cohort and incidence of UR will be calculated to determine if there is a~     difference in UR risk between monotherapy and polytherapy AED use.~   "
160697|NCT01462643|"~     The aim of the exploratory study is to compare dose related effects of LAS41004 formulations~     in a non-occlusive PPT.~   "
160698|NCT01462630|"~     This phase II trial studies how well pazopanib hydrochloride works in treating patients with~     advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
160699|NCT01462617|"~     The study will comprise three Parts:~      Part A will consist of two cohorts of healthy male volunteers to assess the safety,~     tolerability and pharmacokinetics of ascending single doses of nebulised GSK2269557. Blinded~     safety and available PK data will be reviewed before each dose escalation.~      Part B will be one cohort to examine the safety, tolerability and pharmacokinetics of a~     repeated dose of GSK2269557 given by nebuliser for 7 days in healthy male volunteers. The~     total daily dose will be the same as, or lower than, doses that are well tolerated in Part A.~      Part C will consist of two cohorts of single nebulised doses in healthy male smokers, to~     assess pharmacodynamic endpoints in sputum and bronchoalveolar lavage.~   "
160700|NCT01462604|"~     This is a 6-week, single arm, pilot study to test the study procedure, educational materials,~     and measurement instruments for the educational intervention in HER2 overexpressing~     metastatic or advanced breast cancer patients~   "
160701|NCT01462591|"~     Cardiovascular disease (CVD) is considered the primary cause of death in the developed world.~     Large scale epidemiological studies indicate that prevalence of hypertension along with~     adverse cardiovascular events peak during the winter months. Moreover, during the winter~     months outdoor activities and physical stressors such as exercise have been associated with~     higher cardiovascular mortality when compared to other periods of the year. Although low~     environmental temperatures have been implicated as the triggering factor for cardiovascular~     complications, the mechanisms on how cold exposure increase cardiovascular morbidity and~     mortality remain to be elucidated. However, new research suggests that cold exposure may~     induce increases in cardiac sympathetic activity, endothelial damage and increased arterial~     stiffness of central arteries. Cardiovascular drugs including antihypertensive~     pharmacological agents seem to be inefficient to provide appropriate therapeutic effects~     during cold exposure. Therefore, it is imperative to propose alternative non-pharmacological~     therapies intended to prevent the detrimental effects of low environmental temperatures on~     cardiovascular function. Recently, oral supplementation of the amino acid L-citrulline has~     been proposed as an effective therapeutic adjuvant for the treatment of hypertension.~     L-citrulline is known to enhance the bioavailability of L-arginine levels and increase~     endothelial nitric oxide (NO) production, one of the main modulators of vascular tone and~     blood pressure (BP). L-citrulline supplementation has been shown to increase endothelial~     function, reduce BP, and ameliorate endothelial oxidative damage without any adverse effects.~     Our group has demonstrated that L-citrulline supplementation attenuates the BP response to~     cold exposure (the cold pressor test, CPT). These studies suggest that L-citrulline~     supplementation may be a feasible therapeutic aid in order to prevent cardiovascular~     complications associated with cold exposure. However the potential cardioprotective effects~     of L-citrulline supplementation during cold exposure with exercise have yet to be evaluated.~     It is hypothesized that L-citrulline supplementation would reduce arterial stiffness and~     blood pressure (BP) responses to physiological stress (cold exposure). This study may lead to~     the development of an adjunct therapy for the prevention and management of cardiovascular~     adverse events that are particularly increased during the winter months.~   "
160702|NCT01462578|"~     Assessment of efficacy of azacitidine to prevent a relapse~   "
160703|NCT01462565|"~     The purpose of this multicentre, open label, single-arm study in approximately 20 adult~     patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of~     epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).~   "
160704|NCT01462552|"~     In July 2008, the lapatinib (Tykerb) Prescribing Information (label) was updated to include a~     boxed warning related to hepatotoxcity and detailed instructions for monitoring liver~     function before and during lapatanib exposure. For patient safety, it is of interest to know~     the extent to which providers are adherent with these guidelines for hepatic monitoring of~     lapatanib users.~      Thus, the aim of this study is to determine if physicians conduct liver function testing~     prior to prescribing lapatanib and at regular intervals during exposure, and if they withdraw~     lapatanib, and do not re-treat, for patients who demonstrate severe liver enzyme elevations~     while exposed. These aims will be tested in the Pre-label (prior to the boxed warning) and~     Post-label (after the boxed warning) periods to determine if physician adherence to the~     guidelines changed as a result of the warning.~      Specifically, the boxed warning provided the following guidance:~      Hepatotoxicity (alanine transaminase or aspartate transaminase >3 times the upper limit of~     normal and total bilirubin >1.5 times the upper limit of normal) has been observed in~     clinical trials (<1% of patients) and postmarketing experience. The hepatotoxicity may be~     severe and deaths have been reported. Causality of the deaths is uncertain. The~     hepatotoxicity may occur days to several months after initiation of treatment. Liver function~     tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored before~     initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If~     changes in liver function are severe, therapy with lapatanib should be discontinued and~     patients should not be re-treated with lapatanib~      The following objectives will be assessed and compared among patients prescribed lapatanib~     before and after the addition of detailed guidance on liver function testing to the product~     label on July 9, 2008:~        1. Objective 1: Determine if physicians perform liver funtion tests (LFTs) prior to~          prescribing lapatanib (baseline)~        2. Objective 2: Describe the prevalence of LFT elevations at baseline~        3. Objective 3: Determine if physicians routinely perform LFTs during the duration of~          lapatanib exposure~        4. Objective 4: Describe the cumulative incidence and incidence rate of LFT elevations~          during lapatanib exposure~        5. Objective 5: Describe patients that experience severe LFT elevations during lapatanib~          exposure and calculate the proportion that have lapatanib discontinued and are not~          re-treated~      To achieve these objectives, an observational retrospective cohort study will be conducted~     using the United States Oncology Electronic Medical Records database. The study population~     will consist of females with a diagnosis of metastatic breast cancer and a documented order~     for Lapatanib from January 1, 2007 - December 31, 2009. Patients will be categorized by~     whether they initiated Lapatanib before or after the July 9, 2008 label change.~      'Pre Label': Initiated lapatanib between January 1, 2007 and December 31, 2007. Follow-up~     time for this group will continue until June 30, 2008 to allow these patients to have at~     least six months of follow-up time prior to the label change.~      'Post Label': Initiated lapatanib between July 9, 2008 and December 31, 2009. Follow-up time~     for this group will continue until June 30, 2010 to allow these patients to have at least six~     month of follow-up.~      The exposure in this study is lapatanib oral medication. The date of initiation of lapatanib~     will be the index date. Lapatanib exposure period(s) will be defined from the index date~     through to the end of the study period (June 30, 2008 for pre-label group or June 30, 2010~     for post-label group).~      The project will use proportions and two estimates of incidence (cumulative incidence and~     incidence rates using person-time) to describe the outcomes of interest among the users of~     Lapatanib before and after the label change. The following LFTs will be considered:~        -  alanine transaminase (ALT)~        -  aspartate transaminase (AST)~        -  alkaline phosphatise (ALP)~   "
160705|NCT01462539|"~     Adenotonsillectomies are one of the most common childhood surgeries and are first-line~     treatment to correct childhood obstructive sleep apnea syndrome (OSAS). This is a study~     comparing patients with and without OSA looking at the length of stay following~     adenotonsillectomy and the factors affecting length of stay.~   "
160706|NCT01462526|"~     Current screening methods for glaucoma detection are not perfect and nearly half of those in~     the United States with glaucoma go undiagnosed. Minority populations are even less likely to~     be diagnosed. Better screening methods are needed to identify the undiagnosed and to provide~     them care that can help them retain good vision.~      Glaucoma is often more severe in one eye and this fact can be exploited in screening tests.~     The investigators plan to use a novel screening device that very accurately records the~     pupillary response from each eye. It is likely that patients with glaucoma will have abnormal~     responses when measured, and by comparing responses between the two eyes the investigators~     will be able to determine who has glaucoma. If this test works well, it will provide a~     low-cost way to screen populations at risk for glaucoma. Furthermore, this research will~     expand the knowledge base regarding how pupil responses to light differ between persons with~     and without glaucoma. Insights gained from this study will be useful in the development of an~     effective screening tool in the detection of glaucoma.~   "
160707|NCT01462513|"~     Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival~     (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and~     saline infusion).~   "
160708|NCT01462500|"~     The purpose of this study is to determine the pharmacokinetics of miltefosine in children and~     adults with cutaneous leishmaniasis in plasma and intracellularly, and its relation with the~     parasitologic response. The results will provide pharmacologic bases to optimize the use of~     miltefosine for the treatment of cutaneous leishmaniasis, and will provide the knowledge base~     to assess the impact of pharmacokinetic behavior in children and adults on the emergence of~     drug resistance.~   "
160709|NCT01462487|"~     Zanamivir is a neuraminidase inhibitor that has demonstrated effectiveness against the~     pandemic H1N1 virus. Zanamivir was first authorized in Sweden in June 1999 and is approved in~     the European Union (EU) through mutual recognition. It is indicated for treatment and~     prevention of influenza in adults and children over the age of 5 years.~      Zanamivir animal studies, conducted primarily in rabbits, showed a trend towards increased~     post-implantation loss, decreased fetal body weight, and increased minor fetal skeletal~     changes, although these effects were not statistically significant. Given the frequency,~     pattern and distribution of these effects, it was concluded that they were not related to~     zanamivir treatment. The summary of product characteristics for zanamivir states that it~     should not be used during pregnancy unless the potential benefit to the mother justifies the~     risk to the fetus.~      Postmarketing data have shown no higher risk of malformation with oseltamivir than in the~     general population, but data on zanamivir are scarcer. Limited data are available on~     pregnancy outcomes with maternal exposure to zanamivir during pregnancy. From 01 August 2003~     through 31 January 2009, 133 women were reported to have been treated with zanamivir while~     pregnant. Of these 133 pregnancies, 83 pregnancies were on-going or had been lost to~     follow-up (62.4%) at the time of the report; 43 resulted in a live birth with no apparent~     congenital anomalies (32.3%), 4 represented spontaneous abortions with no apparent congenital~     anomalies (3.0%), 2 were elective terminations with no apparent congenital anomalies (1.5%),~     and 1 was an ectopic pregnancy (<1%). The European Medicines Agency (EMA) has concluded that~     exposure to zanamivir during pregnancy does not represent a new safety risk to the fetus.~      Published research has suggested that early antiviral treatment of pregnant H1N1 patients can~     improve outcomes. In a Center for Disease Control and Prevention (CDC) surveillance~     population of 788 pregnant influenza patients with disease onset between April and August~     2009, the 384 with data on timing of antiviral treatment were observed to have significantly~     higher risk of adverse outcomes with later treatment ('intermediate', i.e. 3-4 days, n=84;~     'late', i.e. > 4 days: n=81) than with early treatment (< 2 days: n=219). Compared with those~     given early treatment, those given intermediate treatment had almost 10 times the risk of~     death, and those given late treatment, more than 50 times. Intensive Care Unit (ICU)~     admission showed more than a 2-fold risk elevation with intermediate treatment and a six-fold~     elevation with late treatment, Respective elevations in risk of need for mechanical~     ventilation were almost 4-fold and more than 12-fold. The authors noted that the reason for~     treatment delays in this population are unknown, but could include reluctance on the part of~     clinicians and patients to expose the fetus to antiviral medications, as well as use of rapid~     influenza tests, which have shown low (10%-70%) sensitivity for H1N1.~      As part of their ongoing epidemiologic safety monitoring initiatives requested by the EMA~     during the influenza pandemic of 2009-2010, GSK seeks to conduct a pregnancy safety study to~     better understand the safety of zanamivir in women exposed during pregnancy for either the~     treatment or prevention of influenza. This safety study will collect information from~     existing European databases with records of pregnant women exposed to these products and~     their pregnancy outcomes in order to assess the safety of these treatments in this~     population.~      GSK is working with PPD as the contract research organization (CRO) to oversee conduct of~     this study, including data source management and payment, study design input, epidemiological~     advice, data transfer oversight and overall project management. The CRO will keep a record of~     all relevant personnel involved in the study. Additionally, PPD has a strategic alliance with~     World Health Information Science Consultants, LLC (WHISCON) (www.whiscon.com), an~     internationally recognized organization conducting post-approval drug safety and risk~     management epidemiology. WHISCON will be providing services related to protocol development~     as well as database-specific work plans, and will assist in analysis and interpretation of~     data.~      The primary objective of this study is to evaluate the safety of zanamivir taken during~     pregnancy on 1) the outcome of the pregnancy, 2) congenital anomalies identifiable at or~     shortly after birth, and 3) treatment-emergent diagnoses in the mother occurring within 28~     days of receipt of zanamivir.~      The secondary objectives of this study are 1) to develop techniques for identifying~     influenza-like illness (ILI) in the participating data sources, and 2) to identify the~     characteristics of zanamivir recipients.~   "
160820|NCT01461005|"~     The purpose of the Post-Market Surveillance study is to evaluate safety.~   "
160715|NCT01462409|"~     Heated humidification in CPAP therapy is often not enough to prevent side effects like~     dryness of nasal mucosa and xerostomia, especially in cases of mouth breathing or mask~     leakage. Additionally a higher level of humidification in lower ambient room temperature can~     lead to condensation and irritating noises. Compliance of affected patients decreases~     considerably. Regarding this, devices with humidifier and additional heated tubing are~     developed to automatically regulate optimal humidification and temperature right up to the~     mask. The efficacy of a system with controlled heated humidification and heated tubing in~     nasal masks under various conditions like leakage and different pressure levels is object of~     this study.~   "
160716|NCT01462396|"~     Allogeneic stem cell transplantation has been explored for patients with high risk~     neuroblastoma. Results have been mixed, with only small series and case reports. Recent~     reports, however, especially with haploidentical transplantation have been more encouraging.~     Eradication of neuroblastoma may be mediated by both components of the innate immune system~     (natural killer cells) and through the adaptive immune system via T-cell cytotoxicity and the~     development of a humoral response to tumor specific antigens and minor histocompatibility~     antigens. To overcome restrictions created by unavailability of Human leukocyte antigen (HLA)~     matched donors, stem cell grafts from haploidentical related donors have been explored.~     Historically, the use of full haplotype mismatched family member donors has been limited by~     the development of severe graft-versus-host disease and the high rate of graft failure. Graft~     failure can now be overcome by increasing immunosuppression and increasing the number of~     transplanted stem cells. The most effective means of graft versus host disease (GVHD)~     prophylaxis is T cell depletion of the donor marrow. A 3-4 log depletion will reduce the risk~     of developing significant GVHD to less than 10%. Methods to mobilize stem cells from the bone~     marrow into the peripheral blood and collect these stem cells by apheresis now increase the~     availability of stem cells by a magnitude. Selection devices have been developed that will~     prepare extremely pure populations of these CD34 cells with upwards of 5 logs depletion of~     contaminating T cells. The CliniMACS CD34 Reagent System is a medical device designed to~     select CD34+ hematopoietic cells from heterogeneous hematologic cell populations. The~     investigators intend to provide mismatched related hematopoietic stem cell transplantation to~     up to 10 patients with relapsed refractory neuroblastoma. Harnessing the potential for innate~     and adaptive immune responses through allogeneic Hematopoietic stem cell transplantation~     (HSCT) may provide cure for some patients with this tumor.~   "
160717|NCT01462383|"~     Primary Objective:~      -Evaluate incidence of cardiac complications in Phase I patients.~      Secondary Objective:~      -To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the~     detection of cardiac events.~   "
160718|NCT01462370|"~     This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib~     compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.~   "
160719|NCT01462357|"~     The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix~     administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered~     according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6~     months in 9-14 years old healthy females.~   "
160720|NCT01462344|"~     The purpose of this study is to assess whether the risk of serious asthma-related events~     (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11~     years old taking inhaled fluticasone propionate/salmeterol combination is the same as those~     taking inhaled fluticasone propionate alone.~   "
160721|NCT01462331|"~     The purpose of this study is to re-confirm the already established health effects and dose~     tolerance of Isomalto-oligosaccharide or IMO, which is a general health/functional food~     ingredient.~   "
160722|NCT01462318|"~     The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield~     Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the~     pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS).~     The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC~     HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of~     participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for~     cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).~   "
160723|NCT01462305|"~     The primary objective of this study is to evaluate the effect of light therapy using a narrow~     467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It~     is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm~     light.~   "
160724|NCT01462292|"~     The purpose of this study is to determine if GSK2402968 is effective in the treatment of~     ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be~     corrected by exon 51 skipping. Two doses of GSK2402968 and placebo will be used in this~     study.~   "
160725|NCT01462279|"~     The objective of this study is to determine the effect of thiamine therapy on oxygen~     consumption in critically-ill patients. The investigators will evaluate this by measuring VO2~     before and after thiamine administration in patients admitted to the ICU and requiring~     mechanical ventilation.~   "
160726|NCT01462266|"~     The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg~     once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus~     who have inadequate glycemic control on insulin alone or in combination with metformin. The~     primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of~     insulin relative to placebo.~   "
160727|NCT01462253|"~     This is a multicentric, prospective pilot trial testing a Clofarabine-Cyclophosphamide~     combination to treat refractory and first bone marrow relapse adult ALL, for the achievement~     of a complete remission (CR) and the concurrent evaluation of biological response in ALL~     cells (minimal residual disease, apoptosis and DNA cell damage, pharmacogenomics).~   "
160728|NCT01462240|"~     This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used~     in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and~     long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous~     Femoral components.~   "
160729|NCT01462227|"~     Insulin treatment often causes the blood glucose levels to fall too low. The body usually~     responds to low blood glucose levels by releasing hormones which act against the insulin to~     help correct the low blood glucose levels. However, this hormone response can be altered in~     people with diabetes. Currently there are no therapeutic agents that can be used to improve~     the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people~     who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it~     can also affect the levels of the hormones which are released during hypoglycemia. The aim of~     this study is to determine whether naltrexone can be used to improve and accelerate the~     recovery from hypoglycemia in patients with type 1 diabetes.~   "
160821|NCT01460992|"~     This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS~     pacemaker system when used under specific MRI conditions.~   "
160730|NCT01462214|"~     In the present phase 1-2 study the investigators aim to determine whether depletion of Tregs~     using metronomic cyclophosphamide can enhance the antitumor efficacy of everolimus in~     patients with mRCC not amenable to or progressive after a VEGF-receptor tyrosine kinase~     inhibitor containing treatment regimen. In the phase 1 part of the study the investigators~     will determine the optimal CD4+CD25+ regulatory T cell-depleting dose and schedule of~     metronomic oral cyclophosphamide when given in combination with a fixed dose (10 mg daily) of~     everolimus. In the phase 2 part of the study the investigators will subsequently evaluate~     whether the number of patients who are cancer progression free at 4 months can be increased~     from 50% to 70% by adding metronomic cyclophosphamide (in the dose and schedule determined in~     the phase 1 part) to everolimus. In addition to efficacy, the investigators will evaluate~     treatment toxicity to determine whether this combination strategy is feasible and safe.~   "
160731|NCT01462201|"~     The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1~     System on abdominal midsection circumference reduction relative to no treatment.~      The secondary objective of this study is to assess subject satisfaction measured with a~     self-assessment questionnaire~   "
160732|NCT01462188|"~     The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely~     thrombotic lesion may determine distal embolisation of thrombotic material therefore~     deteriorating myocardial perfusion.~   "
160733|NCT01462175|"~     This multicenter, open label, dose-escalating study will evaluate the safety,~     pharmacokinetics, pharmacodynamics, and efficacy of RO5503781, administered once daily (QD)~     or once weekly (QW) in participants with advanced malignancies except leukemia. Participants~     will receive multiple escalating oral doses in two different dosing schedules (Sch) until~     disease progression or unacceptable toxicity occurs.~   "
160734|NCT01462162|"~     This prospective observational study will investigate the effect of tocilizumab on fatigue in~     participants with moderate to severe rheumatoid arthritis who have an inadequate response to~     disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data~     will be collected from participants for 6 months.~   "
160735|NCT01462149|"~     Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to~     treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected~     chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic~     efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However,~     docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate~     the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with~     advanced ovarian cancer.~   "
160736|NCT01462136|"~     The purposes of this study is to assess the relationship between renal function and~     pharmacokinetics of ACHN-490 Injection.~   "
160737|NCT01462123|"~     Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and~     pathologic data. Real-time imaging technologies, have shown promising results in~     discriminating adenomatous from non-adenomatous polyps.~      The resect and discard strategy for small polyps (based on real-time assessment of the~     histology and on the endoscopic resection without pathological examination) has been shown to~     be cost-effective in simulation models. No data exist about the impact of this strategy in~     clinical practice.~      The aim of present study was to assess whether the systematic use, in the everyday clinical~     practice, of the resect and discard strategy allows to correctly manage patients with small~     colonic polyps.~   "
160738|NCT01462097|"~     Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated~     with impairment in cognition and physical function. The purpose of this study is to test the~     effects of 12 months of aerobic and resistance exercise training compared to health education~     on cognitive and physical performance in 120 older adults with CKD not requiring dialysis.~     The results of this study will be essential for demonstrating the effectiveness of exercise~     in improving function and ultimately preventing disability in this high-risk population of~     older adults.~   "
160739|NCT01462084|"~     Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive~     servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA)~     complicated by central sleep apnea (CSA) due to the chronic use of opioid medications~   "
160740|NCT01462071|"~     Background:~      A low amount of red blood cells in the blood of patients with limited kidney function is a~     well known problem. Besides the lack of substances in the blood like iron or erythropoietin~     the shortened survival of red blood cells leads to the low red blood cell count. Red blood~     cells of patients on kidney replacement therapy (dialysis) die earlier than those of healthy~     persons. They live only about 70 days compared to 120 days in healthy humans. Today little is~     known about the causes for the shorter survival of the red blood cells in patients on~     dialysis. Because inflammation leads to a shorter life of the red blood cells in people~     suffering from several diseases leading to inflammation we would like to learn about the role~     of inflammation in the shortened life of red blood cells of dialysis patients.~      When red blood cells are dying the content is broken down to several substances. One of these~     substances is the gas carbon monoxide (CO). The carbon monoxide is exhaled with the breath.~     The more red blood cells die the more CO is exhaled. That's why we can calculate the lifespan~     of the red blood cells when we measure the amount of CO in breath at the same time as the red~     blood cell count in the blood.~      Aim of the study:~      We aim to learn about the influence of inflammation of on red blood cell survival in dialysis~     patients. To look for factors with effect on inflammation or red blood cell survival, for~     example type of dialysis access, medication or kind of dialysis treatment.~      Study procedures:~      Over the course of the 18 month study, 6 observational assessments will take place. If the~     patient experiences a situation with increased inflammation during the study period (for~     example any kind of infection or intervention) up to two more study visits will take place.~     Each study visit will include blood sampling, performed without the need for an extra needle~     stick, and a breath sampling in order to calculate the red blood survival and to measure~     markers for inflammation in the blood. The breath sample will be taken using the easy to use~     GaSampler device developed by a company called Quintron especially for medical breath~     sampling.~      In order to get a sample of air at the patient's home for calculation of carbon monoxide~     produced in the body we will ask the patients to take home an open empty plastic bottle~     before each study visit. The bottle should be kept overnight on a table or sideboard in the~     apartment. Before leaving home for hemodialysis or in clinic visit the patient will seal the~     plastic bottle with the top, take it to the dialysis center and hand it to the research~     staff.~      Risks:~      The amount of the additional blood drawn is 30 ml; this is the amount 2 tablespoons, at each~     study visit. This does not harm the patient. The breath sampling does not imply any risk.~   "
160741|NCT01462058|"~     The purpose of this study is to investigate whether vitamin D3 (70 micrograms) is better than~     placebo in preventing depression symptoms among employees in health care~   "
160742|NCT01462045|"~     This study will explore the relationship between changes in plasma cortisol and symptom~     reduction resulting from individuals with posttraumatic stress disorder (PTSD) participating~     in an 8-week program of mindfulness-based stretching and breathing exercise. The~     investigators hypothesize that at the completion of participation in the 8-week program,~     exercise-induced symptom reduction will be associated with changes in cortisol levels.~   "
184774|NCT01146171|"~     The purpose of this clinical study is to evaluate the safety and tolerability of CT-322~     monotherapy to determine the recommended dose for phase II and subsequent studies~   "
160743|NCT01462032|"~     This study is designed to evaluate two potential treatments for children with~     Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication.~     Our goal is to develop new interventions for preschoolers with ADHD that will result in~     enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent~     long-term difficulties characteristic of many children with ADHD.~      Both interventions involve weekly playgroups (of roughly five children) in which children~     engage in designated activities while parents engage in groups focusing on parent education,~     support, and their children's activities. It is hypothesized that both interventions will be~     helpful, but that only one will have lasting effects well beyond the end of active treatment.~   "
160744|NCT01462019|"~     Inadequate care during pregnancy and postpartum are predisposing factors for the emergence of~     nipple fissures. The therapeutic approach of nipple trauma care guidelines aimed at the~     breast and the appropriate techniques for breastfeeding. These measures, however, have a much~     more preventive than curative, it is not, in most cases, sufficient to power the closing of~     nipple trauma. The objective of this study was to evaluate the effectiveness of a~     phototherapy device designed specifically for the treatment of nipple trauma.~   "
160745|NCT01462006|"~     Idiopathic pulmonary fibrosis (IPF) is an illness characterized by progressive decline in~     lung function and premature death from respiratory failure. Fibrocytes are a novel population~     of bone marrow-derived circulating progenitor cells that have been shown to traffic to the~     lungs and contribute to fibrosis in animal models of pulmonary fibrosis, and whose numbers~     correlate with the degree of fibrosis and with survival in human pulmonary fibrosis. The~     investigators propose to test the hypothesis that therapy with the mTOR inhibitor, sirolimus,~     reduces the number of circulating fibrocytes in patients with IPF. The investigators propose~     to test this hypothesis in short-term pilot trial of sirolimus in patients with IPF to~     determine its effect on the number and phenotype of circulating fibrocytes.~   "
160746|NCT01461993|"~     This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil~     (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be~     randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection~     being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and~     saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent~     children between the ages of 11 and 17 years old.~   "
160747|NCT01461980|"~     This is a clinical study to assess the safety, tolerance and immunogenic response to~     MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and~     W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine.~     Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized~     into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to~     all injections given throughout the study. An unblinded administrator will be responsible to~     administer the vaccinations to all subjects and will be unblinded to the subject~     randomization in order to determine which subjects were in randomized to group 3 so they may~     receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be~     conducted with all subjects 6-months post their last vaccination to obtain safety~     information.~   "
160748|NCT01461967|"~     This randomized, double-blind, placebo-controlled, cross-over study will assess the safety,~     pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects~     will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part~     2, subjects will receive a single dose of RO5508887 on two occasions, with or without food.~     Anticipated time on study is up to 12 weeks.~   "
160749|NCT01461954|"~     This randomized, double masked, multi-center study is being conducted to support the safety~     and efficacy of FST-100 for the treatment of acute viral conjunctivitis. The study intends to~     show superiority of FST-100 ophthalmic suspension compared to vehicle for clinical resolution~     of acute viral conjunctivitis.~   "
160750|NCT01461941|"~     The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment~     in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after~     topical application of E6005 is also assessed.~   "
160751|NCT01461928|"~     This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and~     safety of subcutaneously administered rituximab in comparison with observation only as~     maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's~     lymphoma (NHL). All participants will receive induction therapy with rituximab (375~     milligrams per square meter [mg/m^2] intravenously [IV] in Cycle 1, then 1400 mg subcutaneous~     [SC] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of~     maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing~     therapy and showing partial or complete response will be randomized to receive either~     rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II~     period and will be followed for at least 15 months. Anticipated time on study treatment is~     until disease progression, unacceptable toxicity or end of study, whichever occurs first.~   "
160752|NCT01461915|"~     The purpose of the study is to determine whether ODSH (2-0,3-0 desulfated heparin), a low~     anticoagulant heparin derivate with preserved anti-inflammatory and anti-neoplastic~     characteristics is efficacious in patients with metastatic pancreatic cancer with gemcitabine~     and nab-paclitaxel ( Abraxane) as first line therapy.~   "
160753|NCT01461902|"~     The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and~     brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic~     brain injury (TBI) patients who have experienced a mild to severe head injury.~   "
160754|NCT01461889|"~     Transfusion-related acute lung injury (TRALI) is the most common cause of transfusion-related~     morbidity and mortality in the United States. It is very common and often unrecognized in the~     critically ill with the greatest incidence occurring in bleeding patients with liver disease.~     Plasma is the most blood component associated with this deadly complication and therefore~     patients with liver disease who frequently receive transfused plasma are at increased risk.~     The optimal plasma transfusion strategy for bleeding patients with liver disease is unknown~     and the investigators will evaluate this clinical question in a small pilot randomized~     controlled trial. The invstigators hypothesize that targetting a more restrictive INR Target~     (2.5) vs. an INR Target (1.8) will result in less hypoxemia, a TRALI surrogate without~     increasing bleeding complications.~   "
160755|NCT01461876|"~     This is a retrospective longitudinal study that evaluates the prevalence and incidence of~     overweight/obesity within an HIV-infected population before and after 12 and 24 months of a~     stable antiretroviral therapy (ART). The study group will be compared to the weight of a~     healthy, matched population that is not infected with HIV. The primary hypothesis states that~     the proportion of HIV-infected persons newly classified as overweight/obese will increase by~     ≥20% after 12 months of initial ART, and this incidence will be greater than that of a~     matched HIV-uninfected control population. The effect of immune function variables, such as~     CD4, HIV viral load, and ART regimen on weight will be analyzed. In addition, the study will~     analyze the effect of weight and immune function markers on the inflammatory markers, high~     sensitivity C-reactive protein (hsCRP) and D-dimer. An HIV samples repository will be used~     for specimens to be assayed for hsCRP and D-dimer.~   "
160756|NCT01461863|"~     This study being conducted in Dar es Salaam, Tanzania, to determine if a protein-calorie~     supplementation (PCS) and micronutrient supplement (MNS) will have an impact on health~     outcomes for HIV-infected pregnant women and their infants.~   "
160757|NCT01461850|"~     Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will~     be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs.~     neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point~     is the evaluation and comparison of the surgical complications of primary surgery and IDS and~     the evaluation of the progression free survival (PFS)~   "
160758|NCT01461837|"~     This study is being done to determine the safety and outcome (long-term control) of a~     high-dose chemotherapy regimen followed by an infusion of CD34 selected (immune cells) stem~     cells from a partially matched adult family member donor, called haploidentical stem cell~     transplantation, in high-risk sickle cell disease patients.~      Funding Source - FDA OOPD~   "
160759|NCT01461824|"~     The investigators are doing this study to look at how different doses of the Depot~     medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens.~     The investigators hope that what the investigators learn from this study will be used to~     develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.~   "
160760|NCT01461811|"~     The purpose of this study was to demonstrate substantial equivalence of an investigational~     toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens~     when worn in a daily wear, daily disposable mode for three months.~   "
160761|NCT01461798|"~     Introduction:~      Cardiovascular diseases have become the leading cause of death from chronic diseases in the~     world. One of the major risk factors for this disease is hypercholesterolemia, caused in most~     cases by a rich-fat diet, so came to our country Benecol ® yogurt, whose active ingredient is~     plant stanol ester that competes with total cholesterol and low density lipoprotein or LDL~     cholesterol by preventing them to be absorbed by the body and reducing blood levels.~      Objective: To evaluate the efficacy of plant stanol ester in Benecol ® yogurt lowering blood~     lipids in moderately hypercholesterolemic patients treated at the CES Clinic during 2011.~      Methods: A randomized crossover clinical trial, double-blind, placebo-controlled study in~     patients between 20 and 50 years with moderate hypercholesterolemia and are cared for CES~     control clinic in Medellin.~      Expected results: Test the effectiveness of plant stanol esters in reducing total cholesterol~     and LDL cholesterol in patients with moderate hypercholesterolemia.~   "
160762|NCT01461785|"~     In this prospective, randomized clinical trial, lipofilling of the midface with Platelet Rich~     Plasma (PRP) is compared with lipofilling of the midface without PRP. The main objective of~     this study is to investigate the effect of the addition of PRP to the autologous fat transfer~     on local skin quality improvement, graft survival, and recovery after the procedure.~   "
160763|NCT01461772|"~     Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for~     patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal~     toxicity and not convenient regimen. Recently, carboplatin has proved to be a good~     radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for~     both patients and physicians. Weekly carboplatin may have similar efficacy with weekly~     cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to~     evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in~     patients with locally advanced cervical cancer.~   "
160764|NCT01461759|"~     The purpose of this study is to treat advanced or recurrent endometrial cancer,~     paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by~     most physicians. Docetaxel may have similar efficacy and more favorable treatment related~     toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators~     aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with~     advanced or recurrent endometrial cancer.~   "
160765|NCT01461746|"~     Previous some studies suggested the addition of chemotherapy to radiation therapy after~     surgery may have survival benefit in patients with high risk endometrial cancer. In addition,~     docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin~     which is currently used in most cases. However, docetaxel plus cisplatin may cause less~     toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators aimed to~     analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after~     surgery in patients with high risk endometrial cancer.~   "
160786|NCT01461473|"~     STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure~     that prospectively enabled access to and the sharing of clinical and research data.~      STAGE II: This was a Comparative Effectiveness Trial (CET) evaluating positive airway~     pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in~     cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data~     collected during the STAGE II study was incorporated in Part 3 of the STAGE I study.~      STAGE III of the COMET study was completion of data analysis and preparation of the~     electronic network informatics infrastructure for use beyond the four Clinical Centers to~     interested CTSA institutions. We also explored expanding ontologies, and the use of federated~     database methodology.~   "
160787|NCT01461460|"~     The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus~     placebo on QTcF.~   "
184791|NCT01145950|"~     To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator,~     Enbrel® 25 mg.~   "
160766|NCT01461733|"~     Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are~     admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence~     that resolves as the patient recovers from their underlying condition. However, patients who~     develop AF can present with a very rapid heart rate that in some cases can put stress on the~     heart which can lead to life threatening heart attacks, low blood pressure or breathing~     problems. Not all patients with AF will have unstable heart function but those who have rapid~     heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no~     unstable heart function are two fold. Patients can be treated by controlling the heart rate~     and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be~     controlled by medication and the AF can be converted by either electrical cardioversion (an~     electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal~     of treatment should be to simply control the heart rate and wait for the patient to~     spontaneously convert to a normal heart rhythm or convert the AF with medication for patients~     who only have the rapid heart rate.~      The objective of this project is to conduct a pilot study to determine if it would be~     feasible to conduct a larger definitive trial that would answer the following question:~     Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart~     rhythm in patients with AF who have a rapid heart rate without unstable heart function.~   "
160767|NCT01461720|"~     This study aims to determine the efficacy of intravenous transplantation of autologous bone~     marrow-derived mesenchymal stem cells in patients with acute middle cerebral artery infarct.~   "
160768|NCT01461707|"~     Obesity among women of childbearing age and excessive weight gain during pregnancy are~     prevalent and steadily increasing health care issues. Regular physical activity is~     recommended to maintain healthy weight gain for pregnant women, however, a majority of~     pregnant women are sedentary. The investigators proposed to conduct a pilot study to estimate~     the potential efficacy of a mobile phone based physical activity intervention in 30~     physically inactive pregnant women.~   "
160769|NCT01461694|"~     The purpose of this study is to compare the efficacy of the IPL system 650advance handpiece~     with the alexandrite laser for the purposes of female facial hair reduction~   "
160770|NCT01461681|"~     Heart failure (HF) affects more than 5 million Americans and is a major source of morbidity~     and mortality. Despite optimal management, over half of patients with HF suffer from pain,~     dyspnea, fatigue, and depression that diminish quality of life (QoL). HF care also exacts a~     huge financial toll with yearly costs of $35 billion. Although consensus guidelines call for~     providing palliative care (PC) to patients with HF to relieve suffering and improve QoL, few~     receive it. The overall aim of this project is to conduct a randomized controlled trial (RCT)~     to determine if an interdisciplinary PC intervention (Symptom Management Service-HF [SMS-HF])~     provided concurrently with standard cardiology care improves symptoms, QoL and satisfaction,~     and reduces resource utilization in outpatients with Class II-IV HF compared to standard~     cardiology care alone. Subjects assigned to the SMS-HF group will receive a 6-month~     interdisciplinary PC intervention based on the investigators successful SMS model of~     outpatient PC for oncology patients and focused on assessment and management of physical,~     emotional, social, and spiritual distress and discussion of treatment preferences.~     Innovations of this study are that it will rigorously assess the impact of the SMS-HF on~     patient outcomes and on resource utilization, a key component to ensuring program~     sustainability. The investigators research team of PC and HF experts is recognized for its PC~     research and has a proven record of collaborating, conducting RCTs of PC interventions, and~     studying outpatients with HF. The environment at UCSF is highly supportive of innovative~     research and of sustaining programs with demonstrated improvements in patient outcomes and~     operational effectiveness. The overall goal is to use the results from this study to support~     an application to the NIH for a multi-center RCT of the SMS-HF and to study similar models of~     concurrent PC for patients with other serious illnesses.~   "
160771|NCT01461668|"~     The investigators will conduct a randomized placebo-controlled double-blinded study of nasal~     decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among~     adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC >256)~     strains.~      Objectives:~        1. To determine the percent of intervention vs. control patients with successful MRSA nasal~          decolonization as determined by bilateral nares swabs following a 5-day twice-a-day~          regimen of retapamulin.~        2. To determine the time to decolonization based upon interim and final bilateral nares~          swabs.~        3. To determine the acceptability of retapamulin by surveying participants about their~          experience and adverse events experienced during this study.~      The duration of participant follow-up is expected to last up to 7 weeks.~      This study will evaluate the safety and effectiveness of Altabax (retapamulin) during~     decolonization of MRSA carriers with mupirocin-resistant strains, stratified by low-level and~     high-level resistance to mupirocin. Mupirocin resistance is increasingly common and there is~     no approved substitute topical agent for decolonization of the MRSA nasal reservoir.~   "
160772|NCT01461655|"~     The aim of this proof of principle study is to evaluate efficacy and safety of the sequential~     application of two marketed products for the treatment of acne vulgaris, using the Split-Face~     model~   "
160773|NCT01461642|"~     The purpose of the study is to establish and clinically evaluate a new approach to treating~     asthma by using information and communication technologies (ICT). A mobile environment, and~     organizational interventions to improve the process of an integrated treatment of people with~     asthma will be identified, developed, introduced and clinically evaluated.~   "
160774|NCT01461629|"~     The purpose of this study is to assess the relationship between cognitive impairment, patient~     self-management, health, and health service use in adults with heart failure (NYHA Class 2~     and 3). The research questions are:~        1. How is cognitive impairment (memory, attention, global and executive function) related~          to various aspects of impaired self-management (knowledge of adherence, adherence to~          sodium restriction and medications, symptom monitoring of weight changes, and decision~          and action to seek care)?~        2. How are these relationships altered when adjusting for medical, demographic, and~          psychosocial factors?~        3. What are the relationships among degree of cognitive impairment, quality~          self-management, health status, and health service use?~   "
160775|NCT01461616|"~     The objective is to describe the interaction of equal doses of NPH insulin (Neutral Protamine~     Hagedorn), insulin Detemir and insulin glargine on IGFBP-1 (Insulin-like Growth Factor~     Binding Protein-1) production as well as immunoreactive and bioactive IGF-I (Insulin-like~     Growth Factor-I) after once-daily injection on three separate visits in type 1 diabetic~     subjects.~   "
160798|NCT01461317|"~     This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of~     etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled~     in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in~     the OLE study.~   "
160776|NCT01461603|"~     Introduction: Protein loss during critical illness is an important problem and is shown to~     predict overall survival. In animal studies, infusion of leucine is shown to increase the~     synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.~      Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral~     artery will promote protein synthesis and inhibit breakdown assessed with local a/v~     phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include~     distinct alterations in muscle signal events, in particular mTOR.~      Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv.~     femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and~     a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of~     arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain~     continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution~     FFa-3OHB.~      Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on~     muscle protein metabolism in humans and contribute to further development of nutritional~     therapy in human catabolic states.~   "
160777|NCT01461590|"~     Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations,~     given to children with severe anaemia will be beneficial in haematological correction and can~     be given safely since respiratory distress and haemodynamic changes result from acidosis and~     compensation in these children rather than from biventricular failure.~   "
160778|NCT01461577|"~     Primary Objective:~        -  To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from~          baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure.~      Secondary Objective:~        -  To determine the change in glycemic control, safety, and treatment satisfaction in~          insulin glargine use in patients following GLP-1 failure.~   "
160779|NCT01461564|"~     Colonoscopy is currently most effective procedure used for detecting colon cancer especially~     in the early stages. Screening colonoscopies are performed in the symptom-free patients at~     risk of familial colon cancer. During colonoscopy air commonly used to insufflate the bowel~     may be retained after the procedure causing pain and discomfort to the patients. One of the~     methods used to reduce pain and discomfort is insufflation of carbon dioxide (CO2) instead of~     air during colonoscopy.~      Aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.~   "
160780|NCT01461551|"~     Most researches revealed that volatile anesthetic sevoflurane has a more marked~     cardioprotective effect against ischemia compared with intravenous agent propofol.However,~     propofol has been suggested to be more benefit for attenuation of surgery-induced~     immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB~     surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol~     and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating~     lymphocytes.~   "
160781|NCT01461538|"~     This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity~     of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous~     malignancies.~   "
160782|NCT01461525|"~     Sphincter preservation surgery in low rectal cancer has been increased due to better~     understanding of tumor biology and advances in surgical technology. Furthermore, a majority~     of patients prefer sphincter preservation rather than living with permanent colostomy. But it~     is not clear whether sphincter preservation is directly related with better quality of life.~     There have been many studies comparing sphincter preservation surgery and abdominoperineal~     resection in many aspects including oncologic and functional outcomes, and the quality of~     life. However, the conclusion remains controversial because of the different results between~     studies.~   "
160783|NCT01461512|"~     Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed~     protective effects during prolonged ischemia in animal studies. Functional blood oxygen level~     dependent (BOLD) magnetic resonance imaging (MRI) shall evaluate the effects of HO-1~     induction during short-time ischemia in skeletal muscle of healthy subjects.~   "
160784|NCT01461499|"~     The purpose of this study is to compare the effects of a direct renin inhibitor (DRI),~     aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes~     under strict blood pressure control with angiotensin receptor blocker (ARB).~   "
160785|NCT01461486|"~     Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway~     pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study~     is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness,~     cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic~     cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea~     -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body~     mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must~     have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three~     groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline~     evaluation, six months, one year and three years, all subjects will be submitted to sleep~     questionnaires, physical examination, ear-nose and throat evaluation, baseline~     polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness~     Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale,~     Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of~     Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality~     of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory,~     metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood~     pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three~     groups. Analysis mean and standard deviation will be used for descriptive statistical and a~     general linear model will be applied for analysis within groups on different time.~   "
160799|NCT01461304|"~     This is a compassionate use study to allow patients already taking triheptanoin (C7) through~     previous studies to continue to receive the supplement. It will also allow triheptanoin~     supplementation in patients with qualifying disorders if they are failing conventional~     therapy.~   "
160800|NCT01461291|"~     Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400~     using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery~     only, in subjects with mild to moderate primary open-angle glaucoma.~   "
160788|NCT01461447|"~     The purpose of the study is to determine the safety and immunogenecity of a third MVA in the~     HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA~     vaccines.~      The investigators postulate that the Immune responses that were observed in the HIVIS 03~     trial are likely to wane over time. To date it is unknown how these responses should best be~     maintained. In this study the investigators seek to boost immune responses, especially the~     antibody responses induced by the second MVA boost.~      Since the HIV specific antibodies were induced only after the second MVA injection, it is~     hypothesized that a 3rd MVA will give rise to even higher and sustained antibody titers.~   "
160789|NCT01461434|"~     Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with~     increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient~     characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF~     has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in~     patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease).~     However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving~     patients at risk.~      Aim of the prospective randomized study is to compare two management strategies for patients~     at increased risk for AF but without a known history of AF. Patients are seen regularly~     (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of~     patients additionally receives a subcutaneous implantation of a loop recorder for continuous~     rhythm monitoring, while the control group remains on standard follow-up. Observation period~     is one year (optional extension for 3 years). The time to first diagnosis of AF is compared~     between groups, blood samples are analyzed for potential biomarkers of AF.~   "
160790|NCT01461421|"~     The proposed project is testing two behavioral interventions designed to improve long-term~     weight loss among participants who struggle with eating in response to stress or emotional~     experiences. Group treatment lasts for 1 year, with assessments lasting 2 years. Participants~     must live in the greater Providence, Rhode Island area in order to be eligible.~   "
160791|NCT01461408|"~     The investigators propose a non-randomized pilot study to assess the feasibility and~     effectiveness of using urban beauty salons as settings for culturally-competent health~     education about HPV vaccination. The educational messages will engage individual women, their~     peer group, their family members and community influencers in a way that is authentic and~     share-able. Involving women in give-and-take discussions with people they trust and~     respect—their hairdressers—will be essential to increasing the number of them who consider~     the HPV vaccine for themselves and for those they care about. The investigators believe that~     it is only after women who are opinion leaders among their peers begin positively supporting~     HPV prevention that it will gain wider acceptance.~      The investigators plan to recruit eight (8) predominantly African American beauty salons in~     Philadelphia and train multiple stylists in each salon to act as in-salon educators and~     facilitators for client recruitment to sexual health education sessions. These education~     sessions will be run by trained health educators (also African American females) and take~     place during down times in each of the salons, on a rotating basis.~        -  The investigators hypothesize the ability to successfully recruit eight (8) beauty~          salons for participation~        -  The investigators hypothesize the ability to successfully train multiple stylists per~          site to talk to their clients about HPV and its impact on women of color~        -  The investigators hypothesize that knowledge and awareness of HPV, as well as intentions~          to vaccinate will significantly improve among women who attend a salon-based health~          education session~   "
160792|NCT01461395|"~     The purpose of this study is to find a non-invasive way to discover DNA (deoxyribonucleic~     acid, which is the genetic material inside your cells) alterations in the sperm's head, in~     the near future leading us to choose the good sperm in a simplified manner. This could then~     increase chances of a successful in-vitro fertilization (IVF) treatment when there are sperm~     abnormalities.~   "
160793|NCT01461382|"~     Is a one-year intervention with Treadmill Desks associated with increased employee daily~     physical activity and decreased sedentariness.~      36 employees with sedentary jobs (87 + 27 kg, BMI 29 + 7 kg/m2) used a Treadmill Desk for one~     year. Daily Physical Activity, work performance, body composition, and blood variables were~     measured at Baseline and 6 and 12 months after the Treadmill Desk intervention.~   "
160794|NCT01461369|"~     The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and~     effective for the treatment of osteoarthritis pain of the hip or knee.~   "
160795|NCT01461356|"~     The hypothesis of the proposed study is that performing total knee arthroplasty through a~     mini subvastus approach results in statistically significant differences in one or more of~     the above functional outcome measures, when compared in a blinded, prospective, controlled,~     randomized manner to mini-medial arthrotomy approach.~        1. Analyses of lower extremity functional activities (gait and stairs)~        2. Strength of thigh musculature~        3. Self-assessment of the functional outcomes~        4. Return to the activities of daily living and sports activities~   "
160796|NCT01461343|"~     The purpose of the study is to find out how the blood flow changes in the lungs of people~     with pulmonary hypertension compared to healthy individuals without pulmonary hypertension.~     We would like to find out if there are differences in how blood flows when subjects are given~     a drug to dilate (widen) the arteries in their lungs and when they breathe extra oxygen. We~     will compare the results to when subjects don't receive any drug or extra oxygen. We hope~     that knowing about these differences will help us to better understand pulmonary hypertension~     and how to diagnose it earlier.~   "
160797|NCT01461330|"~     Data obtained in hypertensive patients without diabetes suggest that increased association of~     non-pharmacological treatment in patients with diabetes and hypertension may be associated~     with an improvement in blood pressure control. Despite the beneficial results found, is not~     yet known the magnitude of the effect of a DASH diet associated with the stimulus of physical~     activity on BP in patients with type 2 diabetes. The beneficial effects on blood pressure of~     an additional non-pharmacological intervention to drug therapy may have an even greater~     impact in patients with treatment-resistant hypertension The aim of this study is to evaluate~     the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and~     hypertension resistant to treatment.~   "
185548|NCT01135927|"~     This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect~     of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.~   "
160804|NCT01461239|"~     There are few randomized controlled trials comparing intraradicular posts used to restore~     endodontically treated teeth, especially considering cast posts and glass fiber posts. The~     investigators study will evaluate the clinical success rates of endodontically treated teeth~     restored with glass fiber posts or cast posts and metal ceramic crown. Individuals included~     in this study should present any tooth with endodontic treatment and need of intraradicular~     retention (post) on maxilla or mandible according to inclusion and exclusion criteria.~     Individuals will be randomly allocated into two groups: (1) endodontically treated teeth~     restored with fiber post and composite resin core and metal ceramic crown or (2)~     endodontically treated teeth restored with cast post and core and metal ceramic crown. A~     sample size calculation will be performed to establish the number of posts needed for~     comparison. All crowns and posts will be cemented with self-adhesive cement. Individuals will~     be examined by calibrated examiners, in years 1 to 3. The reason of failure will be~     categorized as root fracture, fracture of the post, post debonding, clinical and/or~     radiographical evidence of a gap between restoration and tooth or endodontic failure, tooth~     extraction, secondary caries, or marginal defects. The confidence level will be set in 95%.~   "
160805|NCT01461226|"~     The purpose of this study is to objectify the effect of diet and exercise on early markers of~     atherosclerosis in obese children.~   "
160806|NCT01461213|"~     - Primary objective: To assess the safety and tolerability of the AAV.REP1 vector,~     administered at two different doses to the retina in 12 patients with a diagnosis of~     choroideremia.~      - Secondary Objective: To identify any therapeutic benefit as evidenced by a slowing down of~     the retinal degeneration assessed by functional and anatomical methods in the treated eye~     compared to the control eye 24 months after gene delivery.~   "
160807|NCT01461200|"~     The purpose of this study is to find out if the bacteria present in the nose or sinuses of~     people with seasonal allergies changes during their allergy season. Another purpose of this~     study is to see if the bacteria present in the nose and sinuses of non-allergic people are~     the same as allergic people before the allergy season and if it changes during the season.~     Many bacteria are difficult to grow in the laboratory so the investigators are using analysis~     of DNA (the genetic material in cells) of the bacteria in the nose and sinus to find them.~     The investigators will be testing DNA of the bacteria only and not of the human subjects~     taking part in this study. This research is being done to help us understand how allergy~     affects bacteria in the nose and sinuses.~   "
160808|NCT01461187|"~     Abstract:~      Objectives:[The goal is] to confirm if physical activity of medium intensity performed during~     gestation can influence the way of delivery, and observe the adherence to exercise among~     pregnant women with different education levels. Methods: Held at the Center for Breastfeeding~     Incentive in the city of São Sebastião, State of São Paulo (Brazil), between April 7, 2008~     and April 14, 2009, the prospective study involved 66 primigravid women, who were divided~     into two groups: the exercise group (GE) that exercised regularly during pregnancy, and the~     other control group (GC) that did not exercise regularly during same period. The significance~     level adopted in this study was five per cent (p = 0.05).~   "
160809|NCT01461174|"~     The aim of this study is to assess the utility of sleep deprivation as a potential model for~     prediction of clinical efficacy using a combination of cognitive physiological endpoints.~   "
160810|NCT01461161|"~     This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl~     administered to normal healthy adult subjects.~   "
160811|NCT01461148|"~     Patients with advanced microsatellite unstable (MSI-H) colorectal cancer will be vaccinated~     with three so called frame shift peptides (FSPs), AIM2(-1), HT001(-1) and TAF1B(-1) combined~     with Montanide® ISA-51 VG. By this, an immune response directed against MSI-induced FSPs that~     are shared by the majority of MSI-H colorectal cancers can be induced. The aim is to show~     that vaccination against MSI-induced FSPs is safe and can induce or enhance immune responses~     against MSI-H colorectal cancer-associated antigens.~   "
160812|NCT01461109|"~     The underlying goal of this study is to assess [18F] CFPyPB PET imaging as a tool to evaluate~     the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer~     Disease (AD) research participants.~   "
160813|NCT01461096|"~     Men who have sex with men (MSM) have an increased risk of developing anal human~     papillomavirus (HPV) infections, which can be a risk factor for anal cancer. HIV-infected~     women are also at risk of anal cancer. This study will evaluate the effectiveness of the Food~     and Drug Administration (FDA)-approved quadrivalent HPV vaccine, Gardasil, at preventing anal~     HPV infection in HIV-infected MSM and HIV-infected women.~   "
160814|NCT01461083|"~     The underlying goal of this study is to assess [18F]MPPF PET imaging as a tool to evaluate~     the activity of the serotonin 5HT1a receptor in the brain of Parkinson Disease (PD) research~     participants.~   "
160815|NCT01461070|"~     Background:~      - Some bacteria found in the large and small intestines help keep people healthy and aid~     digestion. They may also affect a person s risk of developing cancer. Researchers want to~     study the relationship between intestinal bacteria and breast cancer risk factors. They can~     do this by looking at stool and urine samples from postmenopausal women.~      Objectives:~      - To study intestinal bacteria and its relationship to urine-based markers of breast cancer~     risk in women.~      Eligibility:~      - Women between 55 and 69 years of age with a recent mammogram that showed no signs of~     cancer.~      Design:~        -  Participants will be screened with a medical history and basic health questionnaire.~        -  At home, participants will complete questionnaires about cancer risk factors and food~          consumption.~        -  Participants will also collect urine and stool samples. They will send the samples to~          the designated labs for study.~        -  No treatment will be provided as part of this protocol.~   "
160816|NCT01461057|"~     This randomized, multicenter, open-label study will evaluate two different doses of~     pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line~     treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or~     gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment~     arms. Participants in Arm A will receive a pertuzumab loading dose of 840 mg for Cycle 1 and~     a dose of 420 mg for Cycles 2-6, and participants in Arm B will receive pertuzumab 840 mg for~     all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and~     capecitabine.~   "
160824|NCT01460953|"~     1. Briefly describe the purpose of this protocol: This study is designed to evaluate the~          effectiveness of an educational training video on the topic of health literacy for~          medical students.~        2. Briefly summarize how participants are recruited: OHSU medical students attending~          mandatory trainings on the topic of health literacy during the 1st and 2nd years of~          medical school will be invited to participate in the study.~        3. Briefly describe the procedures subjects will undergo: Completion of a short~          self-administered anonymous survey before and after viewing a 23-minute video about~          health literacy.~        4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test~          questionnaire and 13-item post-test questionnaire designed to assess individuals'~          knowledge about health literacy, and intended clinical practices with respect to health~          literacy.~        5. If this is a clinical trial using an experimental drug and/or device, or an approved~          drug and/or device used for an unapproved purpose, briefly describe the drug and/or~          device: n/a~        6. Briefly describe how the data will be analyzed to address the purpose of the protocol:~          Demographics and responses to individual items will be reported as frequencies and~          percentages within the sample. The investigators will use a chi-square analysis to~          stratify responses by demographic groups and t-tests to measure possible changes over~          time.~   "
160825|NCT01460940|"~     This phase II trial studies how well giving panobinostat together with lenalidomide works in~     treating patients with relapsed or refractory Hodgkin lymphoma. Panobinostat may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological~     therapies, such as lenalidomide, may stimulate the immune system in different ways and stop~     cancer cells from growing. Giving panobinostat together with lenalidomide may be an effective~     treatment for Hodgkin lymphoma~   "
160826|NCT01460927|"~     The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source,~     the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple~     treatments. The primary endpoint is observation of changes to the surface by visual and~     photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort~     of the treatment and the measurement of adverse events.~   "
160827|NCT01460914|"~     Extracorporeal Photopheresis (ECP) is a form of apheresis and photodynamic therapy in which~     the peripheral blood is treated with 8-methoxypsoralen, which is then activated with UV~     light. ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL) and is also~     effective for graft-versus-host disease (GVHD). The investigators would like to study the~     outcomes (response rates) of patients receiving ECP treatment and other factors relating to~     their disease and treatment, as well as procedural events, such as complications.~   "
160828|NCT01460901|"~     This is a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic~     transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory~     neuroblastoma expressing the mesenchymal tumor marker GD2. Three patients will be treated.~     The study will focus on the safety and efficacy of allogeneic, donor derived viral specific~     cytotoxic T-lymphocytes, retrovirally transduced to express a chimeric antigen receptor~     specific for disialoganglioside, GD2, expressed on neuroblastoma.~   "
160829|NCT01460888|"~     The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of olaparib in~     combination with radical radiotherapy in patients with oesophageal cancer who are unsuitable~     for platinum containing chemotherapy.~   "
160830|NCT01460875|"~     This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with~     melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and~     slow the growth of melanoma~   "
160831|NCT01460862|"~     A retrospective database analysis to evaluate the impact of omalizumab on the use of~     corticosteroid, emergency-department visits and hospitalizations among patients with~     uncontrolled asthma and using high-dose Inhaled Corticosteroids (ICS) prior to initiating~     omalizumab.~   "
160832|NCT01460849|"~     Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from~     first year of TIS eligibility, estimate the increased risk of death attributable to each year~     of delayed TIS initiation, and investigate TIS effects across study centers.~   "
160833|NCT01460836|"~     Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine~     (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data~     from published literature.~   "
160834|NCT01460823|"~     The investigators are studying a new way of doing cochlear implant surgery called~     Percutaneous Cochlear Implantation. In this surgery, instead of doing a mastoidectomy where~     about 30ml of bone is removed, the investigators use image-guided technology (similar to GPS~     systems used to guide automobile travel) to drill directly from the surface of the skull to~     the cochlea, removing less than 2ml of bone. To use this technique, three markers (or anchor~     screws) are screwed into the bone around the ear. Next, an x-ray of the head (called a CT~     scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is planned and a drill~     guide (Microtable) is made that mounts on the anchor screws. A drill will be attached to the~     guide and used to drill a path from the surface of the skull to the inner ear (cochlea). The~     implant electrode will be threaded through this path. All of these procedures take place~     under general anesthesia.~   "
160835|NCT01460810|"~     A prospective, experimental, case series of 20 patients, with choroidal melanoma, in which~     pars plana vitrectomy and Silicone oil as vitreous substitute will be used as intraocular~     shielding for attenuating the deleterious effects of radiation dose delivered to healthy~     ocular tissue during Iodine-125 plaque brachytherapy treatment and assess if the treatment~     can reduce the incidence and severity of radiation-induced adverse effects like radiation~     retinopathy and permanent loss of vision.~   "
160836|NCT01460797|"~     The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research~     on Glycemic Index (GI) diets has been largely developed, however the combination with~     metformin in humans was not investigated yet. We hypothesized that the low-GI diet in~     combination with metformin would elicit greater improvements on glucose metabolism, lipid~     profile and body composition on overweight or obese type 1 subjects. This study aims to~     evaluate the metabolic effects of the adoption of dietary advice to follow caloric~     restriction high/low GI diets, and low-GI diet associated with metformin on glucose~     metabolism, lipid profile and body composition on overweight or obese type 1 subjects.~   "
160837|NCT01460784|"~     The investigators propose to conduct a cross-sectional study of 60 participants who are 18-30~     years of age to undergo research PET/CT. The purpose of this study is to investigate the~     relationships between Brown Adipose Tissue (BAT), the adiponectin/leptin (A/L) ratio, and~     components of the metabolic syndrome in young adults.~   "
160838|NCT01460771|"~     The investigators hypothesize that transcranial direct current stimulation over the motor~     cortex will reduce muscle overflow and improve hand function in children with primary or~     secondary dystonia.~   "
160839|NCT01460758|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) is used to modulate the neuronal~     excitability in patients with depression. In the present study the investigators will examine~     whether medial frontal rTMS using a double-cone-coil proves to be superior to conventional~     high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.~   "
160840|NCT01460745|"~     This study is a multi-centre retrospective observational research study which will be~     conducted in UK centres with specialised liver surgical services.~      The study will involve retrospective review of medical records of patients with metastatic~     colorectal cancer (mCRC) with metastases confined to the liver, defined locally as~     unresectable without downsizing therapy at first review by a Hepatobiliary Multi Disciplinary~     Team (HPB MDT). Erbitux is available for use in combination with chemotherapy as a downsizing~     treatment for patients with previously unresectable metastases.~      The study aims to examine liver resection rates achieved in normal clinical practice in order~     to inform National Health Service (NHS) clinical and policy decision making and to further~     understanding of how cetuximab is used in a standard clinical setting. This study intends to~     estimate the proportion of patients with unresectable liver metastases who undergo liver~     resection following downsizing treatment with chemotherapy plus cetuximab.~   "
160841|NCT01460732|"~     This is a cross-sectional study, including adults, either untreated for hypertension, or~     under stable treatment for more than four weeks. Assessment will include:~      Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory~     blood pressure monitoring Home blood pressure monitoring during morning, evening and~     nocturnal measurements with the same device.~   "
160842|NCT01460719|"~     An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated~     Varicella-Zoster Virus (V212) vaccine in participants with hematologic malignancies (HM) who~     are currently receiving anti-CD20 monoclonal antibodies.~   "
160843|NCT01460706|"~     The purpose of this study is to characterize tumour uptake of somatostatin analog~     68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators~     hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor~     which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor~     uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status~     of the tumor specimen.~   "
160844|NCT01460693|"~     Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed~     Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way indicates~     an 89% probability of progression-free survival. Imatinib is not tolerated or effective in~     some patients however, and a proportion of patients become resistant to the drug. SPIRIT 2~     study aims to establish whether a new drug, dasatinib, is superior to imatinib in terms of~     event free survival and therefore will be an effective first-line therapy for newly-diagnosed~     CML patients. This study will also provide crucial long-term survival, quality of life and~     health economic data to assist health care providers and managers to determine the most~     cost-effective drug therapy for CML.~   "
160845|NCT01460680|"~     Polyunsaturated omega-3 fatty acids (ω3 PUFAs) are essential nutrients. Studies indicate that~     the incidence of Major Depression (MD) is inversely related to the consumption of fish (which~     are rich in ω3-PUFAs) and to the concentration of ω3 PUFAs in the plasma or Red Blood Cell~     (RBC) membranes. In several studies, the ω6 to ω3 ratio was elevated (ω6 PUFAs are~     pro-inflammatory, compared to ω3). ω3 PUFAs are also inversely associated with anxiety and~     neuroticism but apparently not with somatization.~      Supplementation of fish oil alleviates joint pain in patients with auto-immune disease.~     Inhibition of pro-inflammatory cytokines (which induce both pain and depression-like~     symptoms) by ω3 PUFAs may underlie the benefit conferred by fish oil consumption . RBC ω3~     PUFA content is lower in patients with Systemic Lupus Erythematosus and chronic fatigue~     syndrome, compared to healthy controls. The ω3 PUFA status of fibromyalgia patients has not~     been assessed.~      Magnesium is an essential nutrient and plays a regulatory role in neural transmission. It is~     not known whether magnesium concentration is associated with pain in humans.~      The objectives of the current study are to 1) compare the mean RBC omega-3 content in female~     fibromyalgia patients compared to that of healthy controls and female SLE patients, and to 2)~     assess the correlation between RBC omega-3 content and between the severity of physical (e.g.~     pain) and mental (e.g. depression) in fibromyalgia and Systemic Lupus Erythematosus (SLE).~   "
160846|NCT01460667|"~     Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of~     stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV)~     and recovery of bowel function. Medications most commonly used to control for post-operative~     pain are opioid medications, whose well known adverse effects include PONV. Currently, no~     studied adequate alternative to opiates exists for mild-moderate pain relief without the~     aforementioned risks.~      The primary goal for this study is to evaluate the the administration of pre- and~     post-operative IV acetaminophen to determine if there is in an overall decrease in the use of~     opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in subjective~     PONV leading to sooner return of bowel function, enabling progression to oral intake and~     decrease in post-operative length of stay.~   "
160847|NCT01460654|"~     This study will investigate the hypothesis that the combination of testosterone replacement~     and alendronate will improve bone density and parameters of bone quality more than either~     medication alone in older men with low testosterone levels and low bone density.~   "
160848|NCT01460641|"~     A research study of rectal cancer perfusion (how blood flows to the rectum over time). We~     hope to learn whether perfusion characteristics of rectal masses may be predictive of~     response to treatment and whether rectal perfusion characteristics can be used to follow~     response to treatment.~   "
160849|NCT01460628|"~     The purpose of this study is to determine if armodafinil improves quality of life and is an~     effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.~   "
160850|NCT01460615|"~     The purpose of this randomized, placebo-controlled trial is to investigate whether~     postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy~     (Whipple) operation may be reduced with cortisone treatment. Treatment is administered to~     high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).~   "
160851|NCT01460602|"~     This is a phase 1/2 Study of VELCADE (bortezomib), Nipent (pentostatin), and Rituxan~     (rituximab) (VNR) in Subjects with Relapsed Follicular, Marginal Zone, and Mantle Cell~     Lymphoma.~   "
160852|NCT01460589|"~     This study sets up the final study end point and three detailed goals as the following.~      The main objective of study: This trial is done to assess the safety and benefit of early~     adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional~     commencement after 2weeks for treatment of patients with colon cancer.~      Detailed goal of study:~      The primary endpoint: This study is designed to assess whether early commencement of adjuvant~     chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate.~      The secondary endpoint: This study aims to compare short-term cumulative complications~     between early and conventional commencement of adjuvant chemotherapy after laparoscopic~     resection of colon cancer. This study will also assess the quality of life and side effects~     of chemotherapy.~   "
160853|NCT01460576|"~     The goal of IMPROV is to identify molecular mechanisms that contribute to lung injury and~     long-term breathing problems in preterm infants by investigating two interrelated biochemical~     pathways: the urea cycle-nitric oxide pathway and the glutathione pathway. The investigators~     hypothesize that prematurity-related limitations in the function of these important~     biochemical pathways contribute to respiratory disease risk over the first year of life.~   "
160854|NCT01460563|"~     The investigators hypothesized that valproic acid will increase rocuronium requirement and~     MgSO4 infusion would reduce requirement of muscle relaxant in craniotomy patients preloaded~     with sodium valproate.~   "
160855|NCT01460550|"~     The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient~     with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal~     reconstruction.~   "
160856|NCT01460537|"~     This open label Phase I study involves treating subjects with advanced cancer with Copanlisib~     in combination with either gemcitabine or cisplatin plus gemcitabine. It will determine the~     maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Copanlisib in combination~     with gemcitabine and Copanlisib in combination with cisplatin and gemcitabine. The trial will~     involve multiple participating sites from the US. Up to a maximum of 70 subjects will be~     enrolled in the study.~   "
160857|NCT01460524|"~     In randomized controlled trials, the use of nebulized hypertonic saline in acute~     bronchiolitis has been reported to improve respiratory distress scores, to reduce length of~     hospital stay and to show a trend towards lower hospitalization rates.~      The investigators aim to verify by an observational study if the rate of hospital admission~     and the length of hospital stay of infants presenting to the emergency department (ED) with~     bronchiolitis decreases after the inclusion of 5.85% nebulized hypertonic saline in the~     treatment strategy of the ED and hospitalization wards.~      The investigators will assess the evolution of hospital admission rates and the length of~     hospital stay in two hospitals that use 5.85% nebulized hypertonic saline for the treatment~     of bronchiolitis and in two hospital that do not use these nebulizations. If nebulized~     hypertonic saline is effective in this setting, then the hospitalization rates and length of~     stay should be lower during the year of hypertonic saline use compared to two previous years~     when this therapy was not used. These parameters would not be modified in centers that do not~     use hypertonic saline.~   "
160858|NCT01460511|"~     This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week~     study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo~     HFA-MDI in pediatric patients who are 4-11 years of age with asthma.~   "
160859|NCT01460498|"~     This is a 2 part study. The goal of the first part of this clinical research study is to find~     the highest tolerable dose of azacitidine that can be given with a TKI that you are already~     taking (such as Gleevec, Sprycel, or Tasigna). The safety of this drug will also be studied.~     The goal of the second part is to see if this combination may improve your response to the~     TKI you are already taking.~      Azacitidine is designed to change genes that are thought to cause leukemia. By changing these~     genes, the drug may help to stop them from causing the disease to grow.~   "
160860|NCT01460472|"~     This is a prospective, randomized, open label, parallel-group, multicenter phase III study to~     evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best~     supportive care versus best supportive care in patients with advanced NSCLC who have achieved~     an Objective Response (Partial or Complete Response) or Stable Disease with standard~     first-line treatment. Also immunological parameters will be evaluated. Best supportive~     therapy will be administered to all patients in the study according to institutional~     standards and includes any subsequent onco-specific therapies. 1082 patients will be included~     in the study, with non-small cell lung cancer in stages IIIA (non-resectable), IIIB or IV.~   "
160861|NCT01460459|"~     Primary Objective:~      The objective of the study is to investigate the effect of a specific frequency of~     Self-monitoring of blood glucose (SMBG) on glycemic control and quality of life in patients~     with type 2 diabetes and who are in stable good glycemic control and using 1 insulin~     injection daily.~      The research question is:~      Does a less intensive frequency of SMBG in insulin-treated patients with type 2 diabetes, who~     are in stable good glycemic control, using 1 insulin injection daily, lead to a clinically~     relevant increase of HbA1c (an increase of 0.5%) and what is the effect on quality of life?~      Secondary objectives:~      The secondary objectives is to investigate the effect of a specific frequency of SMBG on the~     number of hypo and hyper glycaemia, number of extra diabetes-related contacts with the health~     care provider, and the diabetes medication.~   "
160862|NCT01460446|"~     This clinical, prospective, randomized, multi-center study determined if the use of an~     insulin bolus advisor improves glycemic control as measured by a change in HbA1c in patients~     failing multiple daily injection/intensified conventional therapy (MDI/ICT).~   "
160863|NCT01460433|"~     The aim of this study is to find out if the process of HIV replication in the lymph tissue~     and gut tissue of people taking HIV drugs causes long-term damage to the ability of the gut~     to protect you from other infections and health problems.~   "
160864|NCT01460420|"~     The aim of the current study is to improve the outcome of patients with hematologic~     malignancies (in a phase I trial) and more specifically multiple myeloma (in a phase II~     trial) by 2 interventions: reduce the risk of graft-versus-host disease (GVHD) and improve~     the efficacy of the procedure decreasing the risk of relapses after transplant.~      Currently, the standard approach used in most centers to prevent graft-versus-host disease~     after allogeneic transplantation is based on the combination of a calcineurin inhibitor~     (cyclosporine or tacrolimus) plus a short course of methotrexate. Unfortunately, this~     strategy is far from ideal, since the risk of acute GVHD is in the range of 30-40% among~     patients receiving a matched related donor transplantation and even higher among patients~     receiving transplantation from an unrelated donor while the incidence of chronic GVHD is~     60-70% among patients receiving peripheral blood progenitor cells from either a related or~     unrelated donor.~      As far as the patients with multiple myeloma (MM) is concerned, although the development of~     new drugs has markedly changed the outcome and management of these patients, allogeneic~     transplantation so far appears to be the only curative option, especially among those~     patients relapsing after first line treatment. Nevertheless, still new strategies within the~     allogeneic transplant setting are needed to improve its results.~      Relapses may occur either extramedullary (very common in this setting) or systemic. In order~     to reduce the risk of systemic relapses the investigators will use maintenance therapy with~     Lenalidomide (Len) which, together with bortezomib (Bz) should contribute to eradicate~     minimal residual disease (MRD). In case the patient do not obtain complete remission or near~     complete remission after transplant, in addition to the maintenance therapy, the~     investigators will use four intensification cycles with VRD (Bz-Len-Dexamethasone).~      In summary, the goal is to optimize the efficacy of allogeneic transplantation by two~     interventions: one focused on reducing the risk of relapse and the other on reducing the~     incidence of GVHD.~   "
160865|NCT01460407|"~     The study will evaluate the effect of Clarithromycin on the pharmacokinetics (PK) of~     LY2216684 in healthy participants. Side effects will be documented. There will be 2 study~     periods (5 and 9 days) and follow up will occur at least 7 days after the last dose.~     Screening is required within 45 days prior to the start of the study.~   "
160866|NCT01460394|"~     Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in~     two age groups: adolescents and young adults.~   "
160867|NCT01460381|"~     The study will evaluate how genetic profiles respond to LY2216684 and the effect of Quinidine~     on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side effects will be~     documented.~   "
160868|NCT01460368|"~     Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects~     due to blood sugar changes after a meal compared to when LY2409021 is also given with a meal.~      Part B: The purpose of Part B is to evaluate the effect of LY2409021, when given at a dose~     level much higher than what would normally be given, on the electrical activity of the heart~     as measured by ECG in relation to placebo and moxifloxacin.~   "
160869|NCT01460355|"~     Two different treatments were given to large angle horizontal strabismus (eso and exotropia)~     adult patients who agree to participate of the study. Inform consents were required for~     participants. Group 1 (12 patients) received conventional recess-resect surgery plus~     intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only~     conventional recess-resect surgery. The patients were randomly located in one of the groups.~     The angles of horizontal deviation were compared between the groups before and six months~     after treatment.~   "
160870|NCT01460342|"~     This is a phase 3, randomized, double-blind, placebo-controlled, parallel-design,~     multinational study to evaluate the efficacy and safety of tadalafil once-a-day dosing for 12~     weeks in Asian men with signs and symptoms of benign prostatic hyperplasia.~   "
160871|NCT01460329|"~     The purpose of this study is to compare the accuracy and precision of two non-invasive~     methods of measuring cardiac output in critically ill children (<18 yrs). The participants~     will include any patient admitted to Pediatric intensive care unit (PICU) requiring a~     trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent~     cardiac output will be obtained and compared on participants using standard 2-D TTE and~     Ultrasound Cardiac Output Monitor (USCOM).~   "
160872|NCT01460316|"~     The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects~     regarding the relations between the metabolic, the genetic and the environmental factors~     which lead to these cardiopathy.~   "
160873|NCT01460303|"~     Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are~     sometimes temporarily unable to empty their bladders and are sent home with a transurethral~     indwelling catheter attached to a bag which holds urine. The goal of this study is to compare~     a new type of patient-operated catheter without a bag to the catheter with a bag for ease of~     use, comfort and quality of life for patients during the postoperative recovery period. This~     new catheter, the OPTION-vf, is approved by the FDA and is available on the market.~   "
160874|NCT01460290|"~     Objectives: The investigators propose a first-ever, prospective trial of asenapine in older~     adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and~     functional/general health status. Given the dearth of treatment data on older adults with BD,~     findings are likely to be of substantial clinical interest, may inform larger future studies~     and will assist in refining bipolar treatment recommendations.~      Hypotheses:~      Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive~     symptoms in older adults with BD.~      Secondary: Asenapine therapy will be associated with improved functional and general health~     status, improved global psychopathology, and good tolerability in older adults with BD.~   "
160875|NCT01460277|"~     The purpose of this current prospective study is to assess and compare the effects of a~     hydrotherapy exercise programme against a conventional land-based exercise programme in~     individuals with hemiplegia. Both exercise interventions aim at improving posture, balance~     and weight-bearing capability. Patients were randomized to the hydrotherapy or conventional~     therapy groups according to balance function (Berg Balance Scale score) and age (age<59 and~     >60 years). The physical examination consisted of (1) a lower-limb motor function recovery of~     the paretic side score according to the 6-stage Brunnstrom scale, (2) the hemiplegic limb~     strength measured by the Motricity Index, (3) the strength of ankle dorsiflexors and~     plantarflexors by manual muscle testing, (4) the spasticity of the ankle score by Modified~     Ashworth Scale, (5) the trunk function through the Trunk Control Test, (6) the postural~     control assessed by Postural Assessment Scale for Stroke Patients and (7) the functional~     status measured with the Functional Independence Measure. Postural sway was evaluated with a~     pressure platform by using the variables of center of pressure (COP) displacements in the~     mediolateral (ML) and anteroposterior (AP) directions. The results will be collected and~     evaluated using statistical programme SPSS.~   "
160876|NCT01460264|"~     This is an observational study aiming to identify and validate biomarkers (including imaging~     and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular~     disease (CVD) and lung cancer.~   "
160877|NCT01460251|"~     The study is an open-label extension study, offering patients who participated and completed~     previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and~     clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety~     and efficacy data of long term treatment effect of Diapep277.Only patients who completed~     studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L~     will be eligible for this extension study~   "
160878|NCT01460238|"~     The investigators hypothesize that Lipoprotein Lipase (LPL) expression on Chronic Lymphocytic~     Leukemia (CLL) cells will predict a more aggressive clinical course. The results from this~     proposal will validate the use of a novel antibody developed at Dartmouth-Hitchcock in CLL~     and will predict CLL patients that have a more aggressive form of the disease. The~     investigators work will also provide direct evidence that LPL is expressed on CLL cells and~     provides a critical source of fatty acids required by the CLL cells to grow and survive.~     Fatty acid metabolism may become a therapeutic target in CLL in the future.~   "
160879|NCT01460225|"~     This prospective study is designed to evaluate how lubiprostone may affect gastric motor and~     sensory function.~   "
160880|NCT01460212|"~     Study hypothesis: psychotherapy and SSRI treatment effect in different brain way:~     psychotherapy in up to down way and SSRI in down to up way. The investigators will~     explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance~     Imaging analysis in this study. Patients in different groups will be treated by psychotherapy~     or SSRI treatment. They will all be checked with Magnetic Resonance Imaging pro and after 12~     weeks of treatment.~   "
160881|NCT01460199|"~     This study is being conducted to evaluate the safety and tolerability of treatment with~     CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.~   "
160882|NCT01460186|"~     This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is~     to identify germ line genetic factors that influence the risk of metastatic breast cancer.~      1500 patients will be enrolled in this study. Blood samples will be collected after informed~     consent and inclusion in the study.~      Patients will be treated and followed according to the standards of their treating center.~      They will be followed during at least 5 years every 6 months for 3 years then every year.~   "
160883|NCT01460173|"~     Driving simulator programmes are used under a wide range of conditions, and a correlation of~     driving performance and real accident risks in patients with obstructive sleep apnoea~     syndrome(OSAS)could be shown. The most frequently used driving simulator is the Divided~     Attention Steering Simulator (DASS) of Stowood Scientific Instruments Ltd. (SSI). Until today~     there are no reference levels with regards to sex and age in existence. To define the~     boundaries of normality age and sex reference values are to be generated and compared to~     values of patients with OSAS.~      50 male and 50 female healthy subjects (10 of each age decade between 20 and 70 years) will~     perform the DASS for 30 minutes. In the other arm 100 OSAS Patients will perform the test as~     well. A better differentiation of pathologic driving performance and response times of OSAS~     patients should be possible with new reference levels.~   "
160884|NCT01460160|"~     The purpose of this study is to determine whether Dasatinib when added to standard~     chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome~     positive acute lymphoblastic leukemia~   "
160885|NCT01460147|"~     The purpose of this study is to evaluate bone mineral density in adult subjects with~     hemophilia versus a comparator population without hemophilia (non-hemophilia age- and~     gender-matched database) by using the following diagnostic means: dual-energy X-ray~     absorptiometry (DXA) scanning, clinical scales, quality of life (QOL) scales and biomarkers.~     In addition to this osteoporosis study, hemophilic arthropathy of the knee with respect to~     loss of knee cartilage will also be explored by using magnetic resonance imaging (MRI~     substudy). No investigational product will be dispensed.~   "
160886|NCT01460134|"~     This is a study of CDX-1127, a therapy that targets the immune system and may act to promote~     anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias~     and lymphomas), as well as patients with select types of solid tumors.~   "
160887|NCT01460121|"~     The diagnosis and management of acute vertigo and dizziness is most of the time an easy task~     for the general practitioner. However, following an acute vestibular disorder and very often~     with no any overt cause, a considerable number of patients complain on chronic dizziness and~     subjective disturbance of balance despite normal clinical and laboratory tests. Patients~     describe that perceptual visual stimulus provoke or aggravate their symptoms that are~     frequently accompanied by anxiety. These cases have been described in the medical literature~     as Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness and Motion and Space~     Discomfort (2,3,4,5). Treatment of these conditions includes physical therapy (similar to~     vestibular rehabilitation exercises) and anti-anxiety or anti-depressant agents such as~     benzodiazepines and SSRI, however, the effectiveness of these approaches is debatable.~      Because visual stimuli play a crucial role in space orientation and motion perception, it is~     reasonable to hypothesize that certain visual stabilizing signals applied on the peripheral~     visual field (that is involved mainly in the perception of motion) could be of help in~     patients suffering from dizziness. This is the rationale of a new technology (SMB- Senso~     Mental Balance Technology) developed to alleviate the feelings of dizziness.~      Trial is conducted in Meir Medical Center, Israel. Recruitment only in Israel!~   "
160888|NCT01460108|"~     The purpose of this study is to characterize the safety and efficacy of the AeriSeal System~     in patients with advanced upper lobe predominant emphysema and significant collateral~     ventilation as determined by the Chartis System.~   "
160889|NCT01460095|"~     Glycated haemoglobin (HbA1c) is the best surrogate of average blood glucose control in~     diabetic patients. Large-scale studies in the USA and UK have demonstrated that lowering~     HbA1c significantly reduces diabetes complications. Moreover, immediate feedback of HbA1c~     measurement to patients improves control. However, HbA1c is unavailable in most parts of~     Africa, a continent with one of the highest burden of diabetes. To translate these evidences,~     the investigators will provide affordable access to HbA1c measurement and relevant education~     in 2 African countries aiming significant improvement of diabetes control. The investigators~     will develop with local health authorities, training and cost-recovery scheme for long-term~     sustainability.~   "
185580|NCT01135511|"~     The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye~     drops in patients with dry eye disease.~   "
160892|NCT01460056|"~     This observational retrospective healthcare medical record review study is to evaluate and~     differentiate the clinical characteristics and outcomes in peritoneal dialysis (PD) patients~     with either endotoxin-associated sterile peritonitis (e-SP), bacterial peritonitis (BP) or no~     peritonitis (NoP) over a 12-15 month period from dialysis clinics in The Netherlands,~     Germany, Hungary, Portugal, and the United Kingdom (UK).~      The primary study objectives are to:~        -  Describe changes in the peritoneal membrane function and clinical outcomes over time~          between e-SP, BP and NoP PD patients.~        -  Describe and differentiate clinical characteristics during the acute clinical~          presentation of e-SP and BP.~      The secondary study objective is to:~      - Generate a dataset that will facilitate post hoc exploratory hypothesis-generation related~     to clinical and resource utilisation (RU) outcomes in association with e-SP.~   "
160893|NCT01460043|"~     The purpose of this study is to compare outcomes and quality-of-life issues in the treatment~     of menorrhagia, this randomized double blind controlled trial compared homeopathy and~     placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the~     condition was performed during one pre-treatment and three treatment cycles. outcome measures~     were bleeding days, intensity. average pads used during menstrual cycle, abdominal & back~     pain, General health and overall satisfaction.~   "
160894|NCT01460030|"~     This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of~     KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or~     intractable primary hyperparathyroidism (PHPT).~   "
160895|NCT01460017|"~     The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer~     procedure and may yield better results than trabeculotomy trabeculectomy approach.~   "
160896|NCT01460004|"~     The purpose of this study is:~        -  To examine the effect of infra patellar strap treatment on the extent of pain and~          jumping performance tasks in young male athletes diagnosed with patellar tendinopathy.~        -  40 elite male athletes, basketball and volleyball players, ages 14-18, students of the~          academy for sports Excellency will take part in this study~        -  Hypothesis 1: The treatment of infra patellar strap will reduce the level of pain during~          jumping performance tasks.~        -  Hypothesis 2: The treatment of infra patellar strap will improve the squat jump height~          in athletes with patellar tendinopathy during squat jump task.~        -  Hypothesis 3: The treatment of infra patellar strap will improve the drop jump height in~          athletes with patellar tendinopathy during drop jump task.~        -  Hypothesis 4: The treatment of infra patellar strap will improve the one leg jump height~          in athletes with patellar tendinopathy during one leg jump task.~        -  Hypothesis 5: The treatment of infra patellar strap will improve the 30 seconds~          repetitive jumps mean height in athletes with patellar tendinopathy during 30 seconds~          repetitive jumps task.~   "
160897|NCT01459991|"~     Purpose: During lactation, several physiological modifications occur including cellular~     differentiation and proliferation, as well as elevation in inflammation. The role of the~     Mediterranean (MED) diet rich in walnuts has been shown to favorably modify fatty acid~     profiles and to reduce inflammation. The study goal is to evaluate the anti-inflammatory~     effects of the MED diet rich in walnuts during lactation, a time of increased inflammatory~     response.~      Procedures: A randomized, controlled dietary intervention trial among lactating women~     comparing the effects of a Mediterranean-style diet with walnuts to the USDA's MyPyramid Diet~     for Moms was commenced to determine the effects of the diet on fatty acid profiles and~     biomarkers of inflammation in breast milk and material serum/plasma. Secondary outcomes of~     interest include effects of maternal diet assignment on maternal body weight and body~     composition as well as infants' growth and health during the study trial period.~      Population: The study population includes healthy women between the ages of 18-40 years who~     are within 6 months post-partum and plan to breastfeed a minimum of 3 times per day for 6~     months following study entry. There have been a total of 138 participants enrolled in the~     study. All 138 participants are women; 34 identified themselves as Hispanic, and 104 said~     they were not Hispanic.~   "
160898|NCT01459978|"~     Hypothesis: Continuously monitor quality indicators with a specific method (CUSUM: Cumulative~     Sum) will increase the awareness of health care staff in maternity and permit rapid detection~     of a small dip in performance in order to enable prompt investigations and corrective~     measures when necessary , which decrease maternal and neonatal mortality and morbidity.~      Objective: To assess the impact of Cumulative Sum (CUSUM) charts used as a maternity~     dashboard to decreases maternal and neonatal mortality and morbidity.~      Design: Step-wedge cluster-randomized trial with prospective analyses of collected data.~      Setting: ten Maternity departments in France. Population: Data from 60 000 women and infants~     could be collected over 2 year's period.~      Method: Cumulative sum (CUSUM) charts were used to monitor the rate of quality indicators~     previously selected by Delphi method.~      Main Outcome Measures: Composite outcome that considers multiple clinical events : mortality,~     adverse outcomes for women and newborn.~   "
160899|NCT01459965|"~     Endoscopic stent insertion is considered the method of choice for palliation of malignant~     bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent~     exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or~     refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic~     stenting for this relative indication might be justified, if there is a significant~     improvement in quality of life (QOL) of such patients. The aim of the investigators study was~     to determine whether endoscopic stenting for MBDO results in improved QOL.~   "
160913|NCT01459783|"~     Dementia is a condition that is growing in prevalence and which harms not only the afflicted~     individual but also adversely affects the health of their family and other informal~     caregivers. New methods for delivering comprehensive assistance to persons with dementia and~     their caregivers are known to be effective and can delay nursing home placement, but this~     study will discover 1) whether more face-to-face involvement rather than telephone delivery~     of this assistance will work better among poor patients in Los Angeles, and 2) if one method~     is better than the other, what are the differences in costs between them. These data will~     enable administrators in public health care settings around the US and non-profit foundations~     addressing dementia patient and caregiver needs to decide what method provides the best value~     and the best outcome relative to its cost.~   "
160914|NCT01459770|"~     Transitional care strategies focused on enhancing the accuracy and comprehensiveness of~     medication information transfer will lead to improved health outcomes among hospitalized~     patients with chronic kidney disease.~   "
160900|NCT01459952|"~     The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase~     III study.~      After the patient has receiving information about the study and after given written informed~     consent, the patient will be screened.~      The patient's medical history and demographic information will be recorded. The patient will~     then be asked questions in accordance to the study questionnaires, and they will also be~     asked to complete questionnaires regarding quality of life - and finally they be instructed~     on how to complete the diary.~      All patients are randomized to receive standardized rose hip liquid or matching placebo. The~     subject is instructed to take the liquid form of rose hips in the morning and evening meal.~     The subject will also be advised to call the clinic if there is an acute attack of cold and /~     or flu because they must then increase the in-take of study treatment to 3 double dose for 5~     days and then return to normal dose.~      The subject will then be asked a series of questions under study questionnaires, and be~     instructed in how questionnaires (SF-12) and diary filled. This is to provide security to the~     validation output values Investigator or study nurse will take telephone contact with the~     subject once a month, subjects will be asked about how things are going and to remember to~     take the liquid and whether they have completed the diary.~      The last patient visit will take place after 6 months. Any side effects will be reported to~     and reviewed with HybenVital ApS in collaboration with medical experts.~   "
160901|NCT01459939|"~     The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase~     III study.~      After the patient has receiving information about the study and after given written informed~     consent, the patient will be screened. All patients are randomized to receive standardized~     rose hip powder or matching placebo for 3 weeks followed by half the dose standardized rose~     hip (or placebo) for the remaining 12 weeks of the study.~      The patient's medical history and demographic information will be recorded. The patient will~     then be asked questions in accordance to the study questionnaires, and they will also be~     asked to complete questionnaires regarding quality of life - and finally they be instructed~     on how to complete the diary.~      Investigator or study nurse will take telephone contact with the subject after 3 and 6 weeks~     of treatment, subjects will be asked about how things are going and to remember to take the~     capsules and whether they have completed the diary.~      The contact taken after 6 weeks by phone is mainly to guide the subject on how complete the~     questionnaires including VAS scales.~      The last patient visit will take place after 12 weeks. Any side effects will be reported to~     and reviewed with HybenVital ApS in collaboration with medical experts.~   "
160902|NCT01459926|"~     A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and~     Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation~   "
160903|NCT01459913|"~     The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in~     combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV)~     (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC~     genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV)~     infection and will not have cirrhosis of the liver.~   "
160904|NCT01459900|"~     The purpose of this double blind, randomized and sham controlled study is to determine~     whether renal denervation in terms of catheter based ablation in the renal arteries is~     effective in lowering blood pressure in patients with treatment resistant hypertension. The~     blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure~     measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point~     evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and~     forearm plethysmography.~   "
160905|NCT01459887|"~     CD20, the protein which is expressed on the surface of all mature B cells, is active in many~     B-cell lymphomas that express this molecule such as Diffuse Large B Cell Lymphoma (DLBCL),~     the most frequently occurring subtype of non-Hodgkin lymphomas. In clinical practice,~     Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone combination chemotherapy (CHOP) is~     still considered one of the standard treatment to DLBCL. CMAB304(Retuxira), the chimeric~     monoclonal antibody is designed to targeted against CD20 for treatment of lymphoma diseases.~     This trial aimed to observe the safety and efficacy of CMAB304, by added CMAB304 to CHOP~     chemotherapy regimen compared with CHOP chemotherapy alone.~   "
160906|NCT01459874|"~     The purpose of the registry is to evaluate an organizational model fixing roles and behaviors~     of subjects involved in the remote monitoring of patients implanted with pacemakers and~     defibrillators.~      The evaluation will estimate the clinical efficiency and the impact on health service~     resources of the organizational model when this is implemented in the daily clinical~     practice.~   "
160907|NCT01459861|"~     The purpose of this study is to assess early ambulation following total knee replacement in~     patients receiving continuous adductor canal block with posterior capsular injection compared~     to continuous femoral nerve block with tibial nerve block.~   "
160908|NCT01459848|"~     The investigators will do an experiment where 9-12 month old infants are randomized to 30~     minutes of block play or 30 minutes of watching a baby DVD.~   "
160909|NCT01459835|"~     This study tests the hypothesis that modifying the media diet of preschool children so that~     they watch more prosocial programming and less violent programming will result in decreased~     aggression and increased prosocial behavior.~   "
160910|NCT01459822|"~     Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and~     treatment directly affect the survival rate. MiRNA is a post-transcriptional small RNA which~     regulate mRNA expression. The present study was designed to observe the selected miRNA~     expression which evaluate the sepsis prognosis in the progression of sepsis in order to be a~     new target for the treatment of sepsis.~   "
160911|NCT01459809|"~     Primary Objective:~      - To demonstrate the superiority of glimepiride and metformin free combination in comparison~     to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment~     period in patients with type 2 diabetes mellitus.~      Secondary Objectives:~      - To assess the effects of the free combination of glimepiride and metformin in comparison to~     glimepiride or metformin alone on:~        -  Percentage of patients reaching HbA1c < 7%~        -  Percentage of patients reaching HbA1c < 6.5%~        -  Fasting Plasma Glucose (FPG)~        -  Safety and tolerability~   "
160912|NCT01459796|"~     The purpose of this study was to determine the safety and tolerability of rilonacept for~     participants with gout who were initiating allopurinol.~   "
160916|NCT01459744|"~     An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to~     monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when~     necessary. While ICDs reduce sudden cardiac death, patients with ICDs eventually die of heart~     failure or other diseases. As patients near the end of life, physiologic changes (intrinsic~     and extrinsic to the heart) may affect the cardiac conduction system, leading to more~     arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and~     anxiety and may not prolong a life of acceptable quality, it is appropriate to consider~     deactivating the shocking function of ICDs as patients' clinical status worsens and death is~     near. This will be a randomized controlled trial of a physician centered counseling and~     education intervention to improve clinician-patient communication about the management of~     ICDs.~   "
160917|NCT01459731|"~     Collect OCT data to evaluate the range and age trend of eye measurements.~   "
160918|NCT01459718|"~     The primary efficacy endpoint of this interventional study is to evaluate the number of~     patients achieving a complete response (CR), defined as patients switching from intensive~     deferasirox -DFO treatment, at any time point during the 24 months of study, to deferasirox~     monotherapy based on improvement in the cardiac magnetic resonance imaging (MRI) T2* value to~     >10ms, and continue to maintain their MRI T2* to values >10 msec.~   "
160919|NCT01459705|"~     This study is evaluating the efficacy of virtual reality exposure therapy (VRET) by comparing~     it to prolonged exposure therapy (PE) and a waitlist(WL) group for the treatment of post~     traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The~     investigators will test the general hypothesis that 10 sessions of VRET or PE will~     successfully treat PTSD, therapeutically affect levels of physiological arousal, and~     significantly reduce perceptions of stigma toward seeking behavioral health services.~   "
160920|NCT01459692|"~     Neurologically-impaired individuals may have significant neurologic morbidity related to~     epilepsy and seizure disorders. Finding safe, noninvasive methods of decreasing seizures, and~     potentially reversing the epileptogenic process, is of paramount importance in improving the~     lives of those with epilepsy.~   "
160921|NCT01459679|"~     The objectives of this study are to evaluate and compare the safety and efficacy of three~     treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin~     ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing~     maximum corneal curvature.~   "
160922|NCT01459666|"~     This study will test if the use of DysportTM (abobotulinumtoxinA) improves wound healing and~     scarring after Mohs surgery. Research in the laboratory as well as previous studies in humans~     have shown improved wound healing and scarring with the use of a similar medication called~     Botox.~      Dysport may improve wound healing and scarring by relaxing facial muscles and therefore~     minimizes the muscle tension and possibly the inflammation around the wound.~   "
160923|NCT01459653|"~     This international, prospective, observational, open-label, pharmaco-epidemiologic study~     observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are~     receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better~     describe the patient population at risk for FN and treated prophylactically in physician's~     best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns~     involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability~     in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and~     mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor~     response to FN prophylaxis and experience break-through episodes of FN, understand the~     differences between prophylaxis responders and non-responders, and describe the degree to~     which prophylaxis of FN is in congruence with guideline recommendations.~   "
160924|NCT01459640|"~     Osteoarthritis is a progressively degenerative disease resulting in increasing pain,~     impairment and ultimately disability. While the available treatments seek to ameliorate pain~     or improve mobility, these treatments rarely modify the course of the disease, but rather~     attend to its consequences. For early stage osteoarthritis, treatment is largely limited to~     addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs).~     These drugs do not stop the progression of the condition or regenerates damaged cartilage.~      This is a randomized and open labelled study aimed to determine the efficacy of~     intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in~     patients with mild to moderate osteoarthritis.~   "
160925|NCT01459627|"~     OBJECTIVE OF THE STUDY: To test the hypothesis that 6 months DAPT (Dual anti-platelet~     therapy) after second generation DES (Drug Eluting Stent) implantation in STEMI (ST elevation~     Myocardial Infarction) is not inferior to 12 months DAPT in terms of clinical outcomes~     (composite endpoint of all-cause mortality, any MI, any revascularization, stroke and major~     bleeding at 18 months after randomization).~      The trial will incorporate two registers studying respectively the safety outcomes of~     Bivalirudin and Prasugrel combination and Bivalirudin and Ticagrelor combination at 2 and 30~     days. Finally the trial design permits assessment of the clinical outcomes after primary PCI~     for treatment of STEMI with the new Resolute Integrity (Medtronic Santa Rosa Ca, USA) stent~     at 30 days and 6 months.~   "
160938|NCT01459458|"~     This is a community-based participatory study to test a brief intervention to reduce risk for~     intimate partner violence (IPV) and associated unintended pregnancy among young, medically~     underserved women attending family planning (FP) clinics. Women ages 16-29 years utilizing FP~     clinics report higher rates of IPV compared to their same-age peers, experiences associated~     with unintended pregnancy. A critical mechanism connecting IPV with poor reproductive health~     is abusive partners' control of women's reproduction through condom refusal, pressuring women~     to get pregnant, and birth control sabotage, a phenomenon described as reproductive coercion.~     In the investigative team's pilot intervention study 53% of young women using FP clinics~     reported ever experiencing IPV, and 25% reported reproductive coercion, the combination of~     which was strongly associated with unintended pregnancy. The proposed reproductive~     coercion/partner violence intervention was developed collaboratively by community-based~     practitioners, advocates, and researchers, with significant input from FP clients. Designed~     to be implemented within routine FP care, maximizing feasibility and sustainability of this~     program, the intervention provides 1) client education and assessment regarding IPV and~     reproductive coercion; 2) discussion of harm reduction behaviors to reduce risk for~     unintended pregnancy and IPV victimization, and 3) supported referrals to IPV victim~     services. This is a full-scale RCT to assess the effects of this innovative program on IPV,~     reproductive coercion and unintended pregnancy, major health threats for medically~     underserved women. Evaluation of this intervention will involve random assignment of 25 FP~     clinics (unit of randomization) in Western PA to either intervention or control (i.e.,~     standard-of-care) conditions. Female FP clients ages 16-29 (N=3600) will be assessed at~     baseline, 12-20 weeks (FU1), and 12 months (FU2) to assess intervention effects on knowledge~     and behaviors related to IPV, reproductive coercion and related harm reduction, as well as~     unintended pregnancy. Data will be collected via audio computer-assisted self-interview in~     English or Spanish. Chart extraction will track clinic utilization, pregnancy testing, and~     diagnosed pregnancies. Regression models appropriate for longitudinal data from~     cluster-randomized trials will be used to estimate intervention effects.~   "
160926|NCT01459614|"~     Primary Objectives~      To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with~     cisplatin in subjects with metastatic pancreatic cancer based on the progression-free~     survival (PFS) rate at 6 month.~      Secondary Objectives~        -  To assess safety and characterize toxicities of the combination of GTX with cisplatin in~          subjects with metastatic pancreatic cancer.~        -  To estimate 3, 6, 9, 12, 15, and 18 month disease control rate (DCR), PFS, and overall~          survival (OS).~      Study Design~      This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in~     subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be~     enrolled, 28 in the initial cohort and 10 in the expansion cohort~      The study will have a safety run-in phase consisting of 6 subjects. To ensure that the~     combination is safe, the first six subjects will be treated at DL1 and observed for limiting~     toxicity for the first 2 cycles before continuation with further accrual. After the safety~     run-in, the study will be continuously monitored for adverse events.~      The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of~     subjects alive, free of disease progression at 6 months. The treatment regimen would be~     considered of insufficient activity for further study in this population if PFS rate at 6~     months is 50% or less, and the minimum required level of efficacy that would warrant further~     study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes~     interim monitoring for futility using a predictive probability approach. We will stop the~     study early if given the information at the interim analysis, it is unlikely that the PFS~     rate at 6 months will be greater than 50% if the study continues to the end.~   "
160927|NCT01459601|"~     Diabetic patients with poorly control blood sugar are prescribed cabergoline for 1 months and~     their blood glucose is evaluated.~   "
160928|NCT01459588|"~     This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation~     in subjects with dry eye disease.~   "
160929|NCT01459575|"~     This is an open-label, Pilot study.The study hypothesis is that the feasibility and efficacy~     of a non-boosted ATV based HAART will be well as the first line treatment in a Chinese~     resource-limited setting.~   "
160930|NCT01459562|"~     The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic~     profiles of a novel therapeutic drug when administered to healthy volunteers.~   "
160931|NCT01459549|"~     The purpose of this study is to determine whether Roux-en-Y choledochojejunostomy is a more~     effective treatment for the hepatolithiasis patients accompanied with Sphincter of Oddi~     Loose.~   "
160932|NCT01459536|"~     Adequate upper limb function is critically important to maintenance of independence and~     prevention of disability in older adults. The goal of this work is to identify factors that~     contribute to rotator cuff rupture and improved outcomes for repair. Ultimately, the~     investigators seek to identify patients most at risk for rupture and to guide clinicians on~     optimal surgical and rehabilitation strategies. This pilot study will quantitatively~     characterize the morphological (muscle volume and fatty infiltration) and functional~     (shoulder isometric joint strength, movement when performing typical task) changes in the~     muscles of the rotator cuff following supraspinatus tear and surgical repair. The~     investigators hypothesize that patients with supraspinatus tear will have reduced muscle~     volume and increased fatty infiltration of rotator cuff muscles compared to their~     contralateral arm and age-matched controls, which will increase following surgery. The~     investigators further hypothesize that isometric joint strength in these individuals will be~     associated with muscle volume and the degree of fatty infiltration, and that older adults~     with a rotator cuff tear will use a restricted range of motion to accomplish functional~     tasks. This study emphasizes muscle function and composition with application to~     rehabilitation of upper limb function, which complements the theme of the Pepper Center.~   "
160933|NCT01459523|"~     Continuous peripheral nerve blocks (CPNB; also known as perineural catheters) provide~     target-specific pain control for a variety of surgeries. There has been increasing interest~     in the use of ultrasound guidance for regional anesthesia, and many techniques using~     ultrasound alone for perineural catheter insertion have been described. Catheters may be~     placed at various points along the brachial plexus (for upper extremity procedures) or in~     proximity to the femoral and/or sciatic nerve (for lower extremity procedures). To date, the~     optimal ultrasound scanning technique, catheter insertion endpoint, catheter placement~     location per indication, for the majority of ultrasound-guided continuous peripheral nerve~     blocks remain unknown. This study will help provide important information related to optimal~     ultrasound scanning techniques and will help identify ways to improve the success rates,~     onset times, and analgesic effectiveness of these techniques for real patients undergoing~     surgical procedures.~   "
160934|NCT01459510|"~     The American Academy of Pediatrics recommends that parents receive anticipatory guidance~     about how to discipline their children as part of the well child visit. However, physicians~     provide counseling only 25-40% of the time. In regard to the type of discipline, the AAP~     recommends that primary care providers encourage parent to use non-physical forms of~     discipline and discourage parents from using physical punishment. Educational resources are~     needed to help physicians routinely provide these important anticipatory guidance messages.~     In this study, consecutive parents were exposed to routine anticipatory guidance messages~     before the well child visit with the physician. After the clinic visit, parents were invited~     to participate in a research study to assess their attitudes about physical punishment and~     other discipline strategies. The key research question of this study is: Can a brief~     multimedia program (i.e. Play Nicely program) affect parents' attitudes about the use of~     physical punishment? The time frame of the study was June through August of 2010. Data was~     collected immediately after the clinic visit and 2-4 weeks post clinic visit.~   "
160935|NCT01459497|"~     The study is designed to determine whether an accelerated course of hypofractionated~     radiation therapy with daily image guidance and motion assessment/control will allow more~     effective treatment of poor performance status patients with stage II-III NSCLC, who would~     benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per~     fraction).~   "
160936|NCT01459484|"~     The main objective of the study is to assess the survival in patient with non metastatic~     osteosarcoma of the extremities treated with different chemotherapy protocols, according to~     the expression of ABCB1/P-glycoprotein~   "
160937|NCT01459471|"~     The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative~     complications. Staple line reinforcement (SLR) is strongly advocated.~   "
160939|NCT01459445|"~     The purpose of this study is to assess the effects of ethinylestradiol 30µg-drospirenone~     combined with metformin and weight loss by means of dietary intervention on the indices of~     endothelial dysfunction (i.e. flow-mediated dilation and serum endothelin-1), serum~     hsCRP,lipids,insulin resistance and body composition in young women with PCOS.~   "
160940|NCT01459432|"~     The main purpose of this study is to evaluate the duration of immunity after a booster dose~     of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does~     seroprotection persist beyond teenage years and into the early twenties? This is the age~     group which is most likely to carry the organism and to transmit it to other members of the~     population. If a booster dose of MenC vaccine given to adolescents does produce protective~     levels of antibody which persist into early adulthood, this would strengthen the case for~     such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a~     resurgence of the disease in the future.~   "
160941|NCT01459419|"~     The use of oral aCD3 Monoclonal antibody (MAb) alone in subjects with hepatitis C is~     justified on the basis of scientific and medical reasons. There are data in multiple animal~     models that aCD3-alone confers efficacy in models of inflammatory or autoimmune disease and~     induces regulatory T cells and immune-modulation as desired in clinical studies. These~     observations are reinforced by data in the Phase 1 clinical study showing that aCD3-alone~     induced the desired immune-modulation in terms of immunological markers for regulatory T~     cells and appropriate rises and declines in certain cytokine levels.~   "
160942|NCT01459406|"~     Some carbohydrates, particularly fructose, the sugar found in fruit and bread may cause~     bloating, pain and erratic bowel habits (diarrhoea and constipation) particularly in patients~     suffering from the irritable bowel syndrome (IBS). This may be because they are not well~     absorbed in the small intestine and cause water to be trapped in the bowel causing~     distension. Studies have shown that reducing the amount of these sugars in the diet can~     relieve these symptoms. There is some evidence that combining fructose and glucose can reduce~     the symptoms caused by fructose but just why is unclear. In this study, the investigators~     will use a non invasive medical imaging technique called magnetic resonance imaging (or~     MRI) to look at the behaviour of drinks containing these sugars in the bowels of healthy~     human volunteers.~      The investigators will give four different drinks: one beverage consisting of a very well~     absorbed sugar, glucose, another consisting of the less well absorbed sugar fructose, a third~     which is a mixture of glucose and fructose, and a fourth consisting of several fructose~     subunits joined together (called fructan). The investigators will take MRI images of the~     stomach and intestines at intervals for 5 hours and compare these with the feelings of~     distension and bloating in our volunteers. The results will act as control for subsequent~     studies in IBS patients and these may help design diets to reduce symptoms in IBS.~   "
160943|NCT01459393|"~     This study aims to compare in a prospective and randomized way actinic keratosis treatment~     with 5-aminolevulinic acid photodynamic therapy versus cryotherapy, from the standpoint of~     therapeutic efficacy, pain, and cosmetic results.~   "
160944|NCT01459380|"~     This phase I trial studies the side effects and the best dose of veliparib when given~     together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab in~     treating patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer~     that has returned after previous treatment. Veliparib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     pegylated liposomal doxorubicin hydrochloride and carboplatin, may stop the growth of tumor~     cells by, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth by~     blocking the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth~     of tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving~     veliparib together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and~     bevacizumab may kill more tumor cells.~   "
160945|NCT01459367|"~     The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to~     lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the~     clinical dose.~   "
160946|NCT01459354|"~     Post-operative sore throat, cough, and hoarseness of voice are common, uncomfortable,~     distressing sequelae after tracheal intubation. It was postulated that these effects are~     because of irritation and inflammation of the airway. Bimanual laryngoscopy is known to~     improve visual field during intubation. This procedure might reduce laryngeal trauma during~     intubation and therefore reduce the incidence or degree of post-operative sore throat. This~     is the first prospective, double-blinded, controlled study, which is focused on the effects~     of bimanual laryngoscopy on first 24-houred post-operative sore throat (POST).~   "
160947|NCT01459341|"~     Comparison of two non-invasive methods for measuring tissue oxygenation. One is~     Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared~     Spectroscopy (NIRS) - near infrared spectroscopy in patients with critical limb ischemia~     (CLI) undergoing invasive treatment (surgical or endovascular).~   "
160948|NCT01459328|"~     This is a prospective, multicentre, randomized clinical trial comparing two different~     neo-adjuvant radiation-based strategies prior to intended surgery for locally advanced~     adenocarcinoma of the rectum.~      This trial may establish the investigational therapy to be superior to, or at least not~     inferior to conventional treatment.~   "
160949|NCT01459315|"~     The purpose of this study is to describe drug concentrations in blood plasma, rectal fluid,~     rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of~     an investigational HIV medication known as GSK1349572 (dolutegravir).~   "
160960|NCT01459172|"~     The overall objective of this project is to determine the safety and breast tissue~     bioavailability of limonene following massage application of limonene containing massage oil~     to the breast.~   "
160961|NCT01459159|"~     This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in~     Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q)~     Myelodysplastic Syndrome (MDS).~   "
160962|NCT01459146|"~     The purpose of this study is to determine if Artemisinin-based Combination Therapy,~     ACT,(artemether-lumefantrine) used as intermittent preventive treatment (IPT) alone or in~     combination with praziquantel, will have any effects on anemia, malaria, schistosomiasis and~     school sustained attention and concentration.~   "
160950|NCT01459302|"~     The investigators laboratory has been studying families with a history of ALS for more than~     25 years and is continuing to use new ways to understand how genes may play a role in ALS,~     motor neuron disease and other neuromuscular disorders.~      The purpose of this study is to identify additional genes that may cause or put a person at~     risk for either familial ALS (meaning 2 or more people in a family who have had ALS),~     sporadic ALS, or other forms of motor neuron disease in the hopes of improving diagnosis and~     treatment. As new genes are found that may be linked to ALS in families or individuals, the~     investigators can then further study how that gene may be contributing to the disease by~     studying it down to the protein and molecular level. This includes all forms of ALS, motor~     neuron disease and ALS with fronto-temporal dementia(ALS/FTD). We also continue to study~     other forms of neuromuscular disease such as Miyoshi myopathy, FSH dystrophy and other forms~     of muscular dystrophy by looking at the genes that may be associated with them.~      There have been a number of genes identified that are associated both familial and sporadic~     ALS, with the SOD1, C9orf72, and FUS genes explaining the majority of the cases. However, for~     about 30% of families with FALS, the gene(s) are still unknown.~      The investigators also will continue to work with families already identified to carry one of~     the known genes associated with ALS.~   "
160951|NCT01459289|"~     The use of HPV testing in cervical screening has raised concerns about the effect of a~     positive HPV result on women's psychological well being. This is a nested psychosocial study~     of the COCY trial (IRB No. UW 09-377; PI: Prof Hextan Ngan), with the aim to evaluate the~     psychosocial impact of HPV positivity on Hong Kong Chinese women and the modulating effects~     of educational intervention on such impact. Potential participants are identified among those~     who have joint the COCY trial. Participants will be randomized into two groups, namely the~     control group or intervention group. The control group participants will receive their smear~     results and an HPV leaflet by post. The intervention group will receive the leaflet and a~     counseling session on HPV. Self-administered questionnaires will be used to assess~     participants' psychological condition at the receipt of the smear results and at two months~     afterward. It is hypothesized that the level of emotional distress measured at smear result~     notification will be greater than that at two months afterward for all participants.~     Furthermore, participants in the intervention group will have lower psychological distress~     than those in the control group at two months after the receipt of their smear results.~   "
160952|NCT01459276|"~     The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL~     intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA~     of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.~   "
160953|NCT01459263|"~     More than 25 percent of the general population suffers from varicose veins, which has a~     considerable impact on quality of life. Nowadays endovenous treatment modalities for great~     saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new~     tumescent-less technique, that combines mechanical endothelial damage using a rotating wire~     with the infusion of a liquid sclerosant. The current study aims at evaluating short and long~     term outcome after mechanochemical endovenous ablation.~   "
160954|NCT01459250|"~     This study will assess the pharmacokinetics, safety and tolerability of a single dose of~     AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease~     with that in healthy matched control subjects.~   "
160955|NCT01459237|"~     Background:~        -  Cushing s disease can be caused by a tumor of the pituitary gland, a small gland about~          the size of a pea located at the base of the brain. These tumors produce high levels of~          hormones, which cause obesity, diabetes, and growth problems. The cure for this type of~          Cushing s disease is to have surgery that removes the tumor but leaves the pituitary~          gland alone. Currently, magnetic resonance imaging scans are the best way to find these~          tumors. However, many of these tumors do not show up on the scan.~        -  Positron emission tomography (PET) scans use radioactive chemicals to light up parts of~          the body that are more active, such as tumors. Researchers want to try to make the small~          Cushing s disease tumors more active to help them show up on the scans. A special~          hormone will be given before the scan to make the tumors more active.~      Objectives:~      - To test the use of hormone stimulation to improve brain scans for Cushing s disease tumors.~      Eligibility:~      - Individuals at least 8 years of age who will be having surgery to remove Cushing s disease~     tumors.~      Design:~        -  Participants will be screened with a medical history, physical exam, blood and urine~          tests, and imaging studies.~        -  They will have three brain scans before surgery. The first scan is a magnetic resonance~          imaging scan to show a full picture of the brain. The second and third scans are PET~          scans.~        -  The first PET scan will be given without the special hormone. The second PET scan will~          be done more than 24 hours but less than 14 days after the first PET scan. The second~          PET scan will be given with the special hormone.~        -  Participants will have tumor removal surgery through another study protocol.~   "
160956|NCT01459224|"~     Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at~     diagnosis and initial treatment response assessment. At each time point (initial staging and~     treatment response assessment) in addition to standard imaging investigations (PET CT, Chest~     CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo an~     extended MRI scan.~   "
160957|NCT01459211|"~     The purpose of this study is to establish the safety and efficacy of a combination of~     dexamethasone and lenalidomide (Revlimid®) (D+L) in subjects with relapsed or refractory CLL~     who have failed or are unable to tolerate standard up-front therapy with regimens containing~     Fludarabine or in those with mutations in the p53 gene, CAMPATH-1H.~   "
160958|NCT01459198|"~     Human respiratory syncytial virus (RSV) is a common cause of upper respiratory tract~     illnesses as well as more severe lower respiratory illnesses, including bronchiolitis and~     pneumonia. RSV affects almost all children within the first 2 years of life. This study will~     evaluate the safety and immune response to the RSV MEDI ΔM2-2 vaccine among adults,~     RSV-seropositive children, and RSV-seronegative infants and children.~   "
160959|NCT01459185|"~     The investigators confirm the feasibility of 1-year administration of oral fluoropyrimidine~     S-1 as an adjuvant chemotherapy for the patient who received complete resection of non-small~     cell lung cancer. The investigators presume they can achieve high completion rate with low~     toxicity.~   "
160963|NCT01459133|"~     The purpose of this program is to allow patients with diabetes and with specific medical~     needs which require them to use this investigational inhaled insulin product in order to~     adequately manage their diabetes. Treatment use of this investigational product is only~     anticipated when exceptional need is identified by a treating physician on a per patient case~     by case review.~   "
160964|NCT01459120|"~     The purpose of this trial is to determine if door-to-door is more effective than community~     gathering in providing voluntary HIV counseling and testing (VCT) in communities in rural~     Lesotho. The voluntary HIV counseling and testing will be proposed as an integrated part of a~     package of proposed services. The package consists of: Blood-pressure measurement,~     blood-glucose measurement, Body-mass-index (adults), weight for height (children), catch-up~     vaccinations, deworming (children) Vitamin A (children & young women), family planning for~     eligible women, Tuberculosis screening and HIV counseling and testing.~   "
160965|NCT01459107|"~     Background: Millions of people each year sustain injuries, have tumors surgically removed, or~     are born with defects that require complex reconstructive surgeries to repair. In the case of~     hand, forearm, or arm amputation, prostheses only provide less than optimal motor function~     and no sensory feedback. However, hand and arm transplantation is a means to restore the~     appearance, anatomy, and function of a native hand. Although over 70 hand transplants have~     been performed to date and good functional results have been achieved, widespread clinical~     use has been limited due to adverse effects of life-long and high-dose immunosuppression~     needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems,~     all of which can greatly affect recipients' quality of life, make the procedure riskier, and~     jeopardize the potential benefits of hand transplantation.~      Study Design: This non-randomized, Phase II clinical trial will document the use of a new~     immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing hand~     transplantation as a safe and effective reconstructive treatment for upper extremity~     amputations by minimizing maintenance immunosuppression therapy in unilateral and bilateral~     hand/forearm transplant patients. This protocol combines lymphocyte depletion with donor bone~     marrow cell infusion and has enabled graft survival using low doses of a single~     immunosuppressive drug followed by weaning of treatment. Initially designed for~     living-related solid organ donation, this regimen has been adapted for use with grafts~     donated by deceased donors. The investigators propose to perform 30 human hand transplants~     employing this novel protocol.~      Specific Aims: 1) To establish hand transplantation as a safe and effective reconstructive~     strategy for the treatment of upper extremity amputations; 2) To reduce the risk of rejection~     and enable allograft survival while minimizing the requirement for long-term high dose~     multi-drug immunosuppression.~      Significance of Research: Hand transplantation could help upper extremity amputees recover~     functionality, self-esteem, and the capability to reintegrate into family and social life as~     whole individuals. The protocol offers the potential for minimizing the morbidity of~     maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this~     life-enhancing procedure and enabling widespread clinical application of hand~     transplantation.~   "
160966|NCT01459094|"~     The purpose of this study is to see if the absorption and distribution of a fixed-dose~     Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food~     by healthy volunteers.~   "
160967|NCT01459081|"~     The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in~     treatment of influenza A and B virus infections in China.~   "
160968|NCT01459068|"~     The aim of the study is to determine the effectiveness of a transdiagnostic psychotherapy~     intervention - namely, Common Elements Treatment Approach (CETA) - in reducing the severity~     of mental health symptoms experienced by torture and violence survivors displaced from Burma~     into Thailand. Specifically, the intervention seeks to measure reductions (if any) in~     symptoms of depression and trauma.~   "
160969|NCT01459055|"~     Acrofacial vitiligo is a clinical form of vitiligo characterized by macules in distal digits,~     periorificial-facial and ano-genital areas. Vitiligo European Task Force classifies vitiligo~     as generalized or localized; generalized vitiligo may be further sub-divided into acrofacial,~     vulgaris and universalis, and localized vitiligo, into segmental and focal. Some authors do~     not believe that acrofacial is a real vitiligo clinical form, considering it as an initial~     form of vulgaris vitiligo. The aim of this study is to follow early- diagnosed acrofacial~     patients during ten years in order to define if these patients will maintain this clinical~     form or will evolute to a more severe clinical form.~   "
160970|NCT01459042|"~     Recent studies indicate that primary aldosteronism (PA) is a much more common cause of~     hypertension than had been demonstrated historically. In patients with resistant~     hypertension, the prevalence of PA from different clinics worldwide is about 10-20%. As has~     been no such data in China, the investigators are conducting a PA study in different province~     of China to evaluate the prevalence of PA in patients with resistant hypertension.~   "
160971|NCT01459029|"~     The purpose of this study is to compare efficacy and safety of add-on treatment with a~     moderately high dose of D-serine, an NMDA-glycine site agonist, in young, recent onset~     schizophrenia patients who suffer from significant symptoms despite treatment with~     antipsychotics.~   "
160972|NCT01459016|"~     This study will investigate the volume, function and composition of the brain using magnetic~     resonance imaging (MRI) and positron emission tomography (PET) scanning technology in~     participants with memory complaints or early signs of Alzheimer's pathology.~   "
160973|NCT01459003|"~     Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer~   "
160974|NCT01458990|"~     The purpose of this study is to find out whether the use of medications that suppress acid in~     your stomach can change the composition of your bowel bacteria.~   "
160975|NCT01458977|"~     This is a phase IV, multicenter, prospective, randomised, crossover, double blind,~     placebo-controlled and proof of concept clinical trial.~      All subjects fulfilling inclusion criteria will be randomised to add either TDF/FTC~     co-formulation (group A) or placebo (Group B) to their current PI/r regimen, i.e.: DRV/r~     800/100 mg QD or LPV/r 400/100 BID. This will be followed by a crossover addition of TDF/FTC~     co-formulation or placebo.~      Randomization will be centralised in the CRO FLS-Research Support and will be stratified by~     DRV/r or LPV/r intake at baseline to ensure equal distribution in both arms. TDF/FTC~     co-formulation or Placebo will be provided in a double-blinded fashion, i.e.: neither the~     treating physician nor the patient will know whether the patient is receiving TDF/FTC or~     placebo.~      All subjects will receive dietary counselling to promote lipid-lowering diet provided by a~     specialised dietician throughout the study.~      The expected duration of the study for each participant will be 36 weeks. There will be 6~     visits: screening, baseline and weeks 4, 12, 24 and 36.~   "
160976|NCT01458964|"~     Is quetiapine more effective than other medications in the treatment of fibromyalgia.~   "
160977|NCT01458951|"~     This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in~     patients with moderate to severe ulcerative colitis who have failed or be intolerant to one~     of following treatments for ulcerative colitis: oral steroids,~     azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.~   "
160978|NCT01458938|"~     The objective of this pilot study is to determine if degenerative spinal disorders such as~     acute radiculopathy, myelopathy, stenosis, or disc and facet disease cause detectable~     alterations in Substance P levels in saliva, serum and cerebrospinal fluid. If this pilot~     study shows a correlation between Substance P levels and pain associated with degenerative~     spinal disorders, then a larger study will be initiated to determine the feasibility of using~     Substance P levels in the diagnosis and treatment of degenerative spinal disease.~   "
160979|NCT01458925|"~     Prospective, Single arm, Multi-Center~        1. To establish the safety and preliminary efficacy of the Check-Cap System in patients~          with negative FOBT (Fecal Occult Blood Test)~        2. To collect data about the overall imaging of the colon internal surface during the~          passage of the capsule~        3. To develop a correlation map between the imaging of the polyps by optical colonoscopy~          vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by~          CT Colonography [CTC] (in patients which were referred after positive CTC examination)~   "
160980|NCT01458912|"~     The aim of this study is to assess and compare efficacy and safety of BI 54903 at medium~     doses twice daily and high doses once daily (evening dosing) and placebo over an 12-week~     treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low~     dose inhaled corticosteroid (ICS) therapy as demonstrated by a decrease in Forced Expiratory~     Volume in one second (FEV1) (not less than 10 %, and equal to or less than 25%) and an Asthma~     Control Questionnaire (ACQ)-6 score of not less than 1.5 at time of randomisation.~   "
160981|NCT01458899|"~     (Food versus no food) crossover study to measure the effects of food on pharmacokinetics of~     TC-5214 (S-Mecamylamine) in healthy Subjects.~   "
160982|NCT01458886|"~     The aim of this study is to assess and compare efficacy and safety of BI 54903 at doses of~     very low dose twice daily (b.i.d) and low dose once daily (evening dosing) and placebo over~     an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled~     on short acting beta-2 agonist (SABA) therapy alone as demonstrated by a decrease in forced~     expiratory volume in 1 second (FEV1) (not less than 10 %, and equal to or less than 25%) and~     an Asthma Control Questionnaire (ACQ-6) of not less than 1.5 at time of randomisation.~   "
160983|NCT01458873|"~     Vascular access in patients carries a significant risk of accidental extravasation of~     intravenous (IV) fluids and medications with the potential for tissue injury. This~     prospective controlled study assessed the diagnostic utility of using intravenous diluted~     sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium~     bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal~     carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the~     injected bicarbonate will dissolve into carbon dioxide and water and cause a transient~     increase in the measured exhaled CO2.~      The effect is unique to bicarbonate and will not appear once normal saline is injected. the~     safety of the administration of bicarbonate on the metabolic profile of the volunteers will~     be assessed by measurement of venous blood pH and electrolytes.~   "
160984|NCT01458860|"~     Atherosclerosis is the major contributor for the morbidity and mortality for the variety of~     cardiovascular diseases.~      Aortic calcification on x-ray is a marker for arterial atherosclerosis and an independent~     prognostic factor for the morbidity and mortality from a cardiovascular event.~      Carotid artery stenoses is the current accepted indication for interventional treatment of~     carotid artery, for the prevention of embolic event, while other arterial atherosclerosis~     indication, is for hemodynamic disturbance and ischemic outcome.~      This research will try to find whether incidental aortic calcification can predict carotid~     artery stenosis.~      Two groups will be chosen: group A - patients who had CT scan in the hospital (for different~     indications); Group B - patients (not from the first group) who have a significant carotid~     artery stenosis who are indicated for interventional treatment.~      The data to analyze:~      Group A - Patients with aortic calcification, carotid artery stenosis, and patients with both~     Group B - Patients who have aortic calcification Comparison of the populations within the~     group and among the two will show if a significant correlation between aortic calcification~     and carotid artery stenosis exist.~   "
160985|NCT01458847|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of~     intravesical cis-urocanic acid in patients with primary or recurrent non-muscle invasive~     bladder cancer.~   "
160986|NCT01458834|"~     Several studies indicate that cigarette smokers show an attentional bias for~     cigarette-related cues, meaning that they more quickly detect and attend to and have more~     difficulty disengaging in cigarette-related information than neutral information. This bias~     is associated with craving and relapse following attempts to quit. This experiment will~     examine whether a computerized attentional training procedure will successfully reduce~     attentional bias towards smoking cues and reduce craving in regular cigarette smokers. The~     attentional training will be administered in a novel format in which participants complete~     5-minute long training sessions 3 times per day and can complete the trainings via home~     computer or handheld device such as the iPhone, Android phone, or iPod touch. A baseline~     assessment in the laboratory will measure attentional bias to smoking cues and craving~     following smoking cue exposure. Participants will then be randomly assigned to either the~     active training condition or a control condition. In both conditions, participants will be~     asked to complete brief training sessions 3 times daily for one week using their personal~     computer or handheld device. Following one week of training, participants will return to the~     lab for endpoint assessment of attentional bias and craving. The investigators hypothesize~     that compared to the control condition, the active training condition will significantly~     reduce attentional bias toward smoking related cues and cue-induced cigarette craving.~   "
160987|NCT01458821|"~     The purpose of this research study is to determine whether the Brain Fitness Program-Tinnitus~     affects how tinnitus is perceived and if its use aids in the recovery of cognitive functions~     that may be affected by tinnitus. The investigators hope to better understand areas of the~     brain involved with or changed because of tinnitus. The investigators also hope to see if the~     Brain Fitness Program-Tinnitus impacts changes in those areas of the brain the investigators~     believe may be affected by tinnitus.~   "
161213|NCT01455844|"~     The purpose of this study is to determine whether CaPre(TM), given at doses 1.0g or 2.0g for~     12 weeks, has an effect on fasting plasma triglycerides in patients with mild to high~     hypertriglyceridemia as compared to a placebo.~   "
160988|NCT01458808|"~     Objective: To evaluate the influence of dietary sodium reduction on body fluid volume and~     inflammatory state in hemodialysis (HD) patients.~      Design: Prospective controlled randomized study. Setting: Dialysis Unit of Botucatu Medical~     School Hospital, Sao Paulo State University, Brazil.~      Patients: Adult patients on HD for at least 30 days and C-reactive protein (CRP) ≥ 0.7 mg/dl~     were randomly allocated into two groups: Group A: 21 patients treated with a 2g sodium~     restriction in their habitual diet, and Group B: 18 controls. Inflammatory, biochemical,~     hematological and nutritional markers, as well as dialysis dosage were assessed at baseline~     and after 8 and 16 weeks.~   "
160989|NCT01458795|"~     The aim of this study is to evaluate the morphologic and hemodynamic changes in the calf~     perforators after endovenous laser ablation of saphenous veins.~   "
160990|NCT01458782|"~     ACI-C versus AMIC: A controlled randomized trial comparing Autologous Chondrocyte~     Implantation ( ACI) and Autologous Matrix Induced Chondrogenesis (AMIC) for repair of~     cartilage defects in the knee.~      Eighty patients (Forty in each group) having symptomatic cartilage defects in their knee are~     planned to include in this study.~      Both techniques will use the ChondroGide membrane from Geistlich to cover the defects. ACI~     includes an arthroscopy to harvest cartilage for cell cultivation in our lab located in~     Tromso. 3-4 weeks later using a mini arthrotomy the cells will be implanted under the~     ChondroGide membrane.~      The AMIC group will be listed for a mini arthrotomy, cleaning of the defect, microfracture~     and cover of the defect using the same ChondroGide membrane.~      In both groups stitches and fibrin glue will be used to fix the membrane.~      Inclusion criteria:~      Age between 18-60, Informed consent signed by patient, Symptomatic cartilage defect. Size~     more than 2 square cm.~      Exclusion criteria Alcohol or drug abuse during the last three years, Inflammatory joint~     disease, Serious illness~      Preoperative examination and follow up: Clinical examination and registration of KOOS (a~     validated knee score), VAS (visual analog pain scale) and Lysholm knee score. Radiographs of~     the involved knee including weightbearing standing radiographs of both knees. Kellgren-~     Lawrence classification will be used for grading of OA.~      Patients will be checked after 1, 2, 5 and 10 years following surgery. Symptomatic patients~     having a new cartilage resurfacing operation or prosthesis will be listed as failures of the~     initial treatment.~      Hypothesis: AMIC will be equal to ACI, and if that is the case this would be a benefit for~     the patients and the society. AMIC is much cheaper compared to ACI (needing an expensive cell~     cultivation and two surgeries).~      Data will be analyzed using the SPSS statistical package.~   "
160991|NCT01458769|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     isotopologs of Atazanavir both as single agents and as combinations.~   "
160992|NCT01458756|"~     Organ transplantation has a special place in the medical field. It symbolizes a medicine~     whose limits always seem to be repelled. Because transplantation is unusual, it places people~     in front of outstanding issues which he has to cope with his personality and history. Factors~     involved in the psychology of patient presenting with graft are past and present psychic~     functioning, object relations, experience of transplantation itself and quality of social~     environment.~      Before or after graft defense mechanisms can be so intense that they can make the patient~     unable to overcome the graft. Yet as a pathological mechanism that denial was considered~     beneficial provided it is short.~      The aim of this study is to evaluate on psychopathological influence of psychological defense~     mechanisms used by liver transplant patients on their somatic psychological and social~     outcome.~   "
160993|NCT01458743|"~     The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of~     ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.~   "
160994|NCT01458730|"~     The purpose of the study is to test the efficacy and tolerability of a multiagent~     chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma~     in the brain.~   "
160995|NCT01458717|"~     Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline~     resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III~     study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable~     pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with~     neoadjuvant chemoradiation therapy.~   "
160996|NCT01458704|"~     Next generation sequencing (including targeted gene seqeuncing, exome and transcriptome~     sequencing) will be performed from fresh frozen tumor samples to understand the genetic~     alteration of tumors and to aid in optimal selection of further therapeutic agents.~   "
160997|NCT01458691|"~     The purpose of this study is to compare the efficacy of intra-articular allogenic Platelet~     Rich Plasma injection and steroid injection in the treatment of adhesive capsulitis of the~     shoulder.~   "
160998|NCT01458678|"~     Goal directed volume therapy means that bolus doses of 150-250 ml colloid fluid is~     administered to the patient during contemporary measurement of the patients stroke volume.~     The fluid status is considered optimized when stroke volume no longer increases with more~     than 10%, indicating that the patient is close to the top of the Frank-Starling curve.~     Several studies show that volume optimization reduces hospital stay and reduces the amount of~     surgical complications. The overall purpose is to investigate if the much more simple non~     invasive technique Pleth Variability Index can replace oesophageal doppler to guide volume~     therapy in routine health care, and to analyse if a volume kinetic test can be used to~     evaluate hypovolemia before surgery and make specific rehydration possible by analysing the~     correlation between this test and fluid optimization using stroke volume measurements.~      Primary hypothesis: 1. The volume of colloids that is given to volume optimise an~     anesthetized patient using Pleth Variability Index shows a good correlation to the volume~     used if volume optimisation is undertaken by the guidance of oesophageal doppler. 2. Data~     from the two methods correlate and discriminates similarly volume responders from non~     responders. 3. A volume kinetic model that indicates dehydration can predict the need for~     rehydration in order to achieve a well hydrated patient at start of surgery.~   "
160999|NCT01458665|"~     -  The purpose of this study is to compare the clinical and anatomical outcomes of rotator~          cuff repair with Platelet-Rich Plasma (PRP) and conventional rotator cuff repair in~          treatment of medium to large rotator cuff tears.~        -  PRP application to arthroscopic rotator cuff repair would accelerate recovery after~          arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall~          satisfaction, and enhance structural integrity of repaired tendon.~   "
161010|NCT01458522|"~     This a phase 2 study comparing the efficacy of intravenous (IV) lacosamide (LCM) with IV~     fosphenytoin (fPHT) in controlling frequent nonconvulsive seizures (NCSs), the Adverse Events~     profile of LCM compared with fPHT when used to treat frequent NCSs, and length of stay in an~     intensive care unit for subjects treated with LCM versus subjects treated with fPHT. The~     trial will include a preacute-treatment period, an acute-treatment period, a~     postacute-treatment period, and a long-term follow-up period.~   "
161000|NCT01458652|"~     Accumulating evidence suggested that increased oxidative stress (OxSt) as well as~     inflammation are risk factors for cardiovascular events in hemodialysis patients. The~     incremental effect of online haemodiafiltration (OL-HDF) on markers of microinflammation ,and~     OxSt is less clear. Besides, the relationship between protein-bind uremic toxin and~     microinflammation remains obscure. The aim of this study was to evaluate the effect volume~     replacement of on-line hemodiafiltration on proinflammatory peripheral monocytes (percentage~     of CD14+CD16+ cells), PAF, IL-6 and on the plasma level of several oxidative stress markers~     as well as several protein-bound uremic toxins such as p-cresol, indole sulfate etc. In a~     case controlled study, 30 patients on OL-HDF will be evaluated. The association between~     protein-bound uremic toxins such as p-cresol, indole sulfate etc and AST-120, a spherical~     adsorptive carbon preparation (Kremezin) will also being investigated.~   "
161001|NCT01458639|"~     Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA)~     imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging~     for the diagnosis of Pulmonary Embolism (PE).~   "
161002|NCT01458626|"~     Although treatment guidelines manifest that antidepressant response usually appear with a~     delay of several weeks and suggest that treatment should be changed if a partial response has~     not occurred after 4~6 week, these beliefs are no longer held by experts, and a new concept~     is raised that the first 2 weeks of treatment may be a useful strategy for improving the~     management of depression. New evidence indicates that early treatment response can be~     predicted with high sensitivity after 2 weeks of treatment in patients with major depressive~     disorder (MDD).~      Early improvement not only predicted response or remission, but also that lack of improvement~     was associated with little chance of response if the treatment strategy remained unchanged.~     The criterion of a 20% score reduction has been chosen as an early indicator of improvement~     because it can be reliably measured in clinical trials and translates into a clinically~     relevant change in the severity of depressive symptoms.~      Antidepressants that enhance both serotonergic and noradrenergic neurotransmission may be~     more effective than selective serotonin reuptake inhibitors (SSRIs) for acute-phase therapy~     of major depressive disorder. As a noradrenergic and specific serotonergic antidepressant,~     the antidepressive mechanism of mirtazapine is quite superior to SSRI and in particular has~     been suggested to have a faster onset of action than SSRIs in MDD patients.~      The aim of this study is to provide physicians with further information regarding early~     improvement and the effectiveness of mirtazapine combined with a SSRI antidepressant therapy~     in nonresponders.~   "
161003|NCT01458613|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     Maroteaux-Lamy dis-ease from plasma and sputum~   "
161004|NCT01458600|"~     AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease~      Background - Already at diagnosis of Graves disease approximately 98% of the patients have~     morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known~     to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation~     is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when~     treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase~     differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma~     agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological~     concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack~     this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of~     importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and~     adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID~     like diclofenac may affect both. There is only one earlier study demonstrating effects of~     NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms~     and eye protrusion.~      Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of~     ophthalmopathy.~      Specific aims:~        1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months~          treatment with or without diclofenac.~        2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy~          after 12 months treatment with or without diclofenac.~        3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months~          treatment with or without diclofenac.~      Study plan and randomisation -~      150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with~     anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18~     months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12~     months.~   "
161005|NCT01458587|"~     The purpose of this study is to determine if Levulan PDT is safe and effective in the~     treatment of actinic keratoses on the upper arms and hands.~   "
161006|NCT01458574|"~     The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and~     tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to~     assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves~     mucosal healing and improves quality of life in subjects with UC.The study proposes to assess~     CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18~     years with UC.~   "
161007|NCT01458561|"~     This is a prospective, multicenter, randomized, controlled investigation. Subjects in which~     bleeding from the exposed parenchymal surface is observed intraoperatively following the~     ligature of vessels visible with the unaided eye will be randomized to an adjunctive~     application of BioFoam or a standard topical hemostatic agent (Gelfoam with thrombin, in the~     form of Gelfoam Plus) to the entire exposed parenchymal surface. Following primary treatment~     of the exposed parenchymal surface as prescribed by the randomization scheme, treatment sites~     will be visually evaluated for the continued presence of bleeding. The overall objective of~     this investigation is to collect clinical data concerning the safety and effectiveness of~     BioFoam used as an adjunct to conservative measures of achieving hemostasis, such as manual~     pressure, cautery, and ligation, for intraoperative capillary, arteriolar, and venular~     bleeding (5 second stack of 5 gauze surface Bleeding Score = 1b or 2, score to be~     validated) on newly resected liver parenchyma in hemodynamically stable (American College of~     Surgeons' Advanced Trauma Life Support Class I Hemorrhage) and non-coagulopathic patients in~     the open treatment of exposed liver parenchyma versus a standard topical hemostatic agent,~     Gelfoam Plus. It is not intended for traumatic liver injury. The investigation will be~     conducted at a maximum of three investigational sites.~   "
161008|NCT01458548|"~     Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of~     transplant recipients and can be EBV-associated. To improve long-term efficacy after~     rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the~     investigators initiated an international multicentre phase II trial to test whether the~     subsequent application of rituximab and four courses of three-weekly CHOP would improve the~     outcome of patients with PTLD: PTLD-1, sequential treatment (ST).~   "
161009|NCT01458535|"~     The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of~     ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve~     participants with genotype 1, 2 or 3 chronic HCV infection.~   "
161011|NCT01458509|"~     It can be difficult to obtain the perspective of patients who have had bowel surgery. This~     study is being done because the investigators are trying to find out whether patient-reported~     outcomes, (results reported to investigators by the patient), on a regular basis, will help~     the investigators provide better patient care and symptom management.~      Therefore, the purpose of this study is to determine if it is possible and if it is useful to~     their medical care for patients who have had bowel surgery to complete surveys about their~     symptoms on a regular basis. In this study the surveys are completed from home, by web or by~     telephone, every month for 6 months. The results of this study will guide the design of large~     research studies on cancer-related bowel function.~      The purpose of this study is to develop a bowel function questionnaire for patients with~     colorectal cancer. The questionnaire will be used in future clinical trials to assess bowel~     function.~   "
161012|NCT01458496|"~     A health coaching intervention in those with pre-disease (pre-hypertension or pre-diabetes)~     but without pre-existing cardiovascular disease will effectively help participants change~     their lifestyle behaviour and prevent or delay onset of cardiovascular disease.~   "
161013|NCT01458483|"~     The Acute Carotid Sinus Endovascular Stimulation II (ACES II) Study is a multicenter,~     prospective, non-randomized study that is being conducted to evaluate the feasibility of~     endovascular stimulation of carotid sinus nerves via an electrophysiology (EP) catheter~     advanced into the internal jugular vein (IJV). The current study investigates the hypothesis~     that intraoperative electrical stimulation of the carotid sinus from the IJV will result in~     an acute and dose-dependent reduction in blood pressure and heart rate.~   "
161014|NCT01458470|"~     Huntington disease is characterized by difficulties in movement and thinking. Psychological~     disturbances including irritability, aggression, loss of interest, depressed mood, obsessions~     and compulsions, also represent common symptoms of HD. These symptoms are distressing both~     for HD patients and their caregivers, contribute to the loss of ability to carry out~     activities of daily living, and present a major treatment challenge for physicians. The goal~     of this study is to determine the effect of memantine on movement, thinking and emotional~     difficulties in HD patients. Memantine is a medication originally approved for the treatment~     of aggression and agitation in patients with moderate-to-severe Alzheimer's disease (AD),~     which has also recently been shown to improve the behavioural and neuropathological symptoms~     in a mouse model of Huntington Disease (HD).~   "
161015|NCT01458457|"~     Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease~     specific quality of life of an individualized additional complementary medicine treatment in~     addition to usual care with usual care only in 280 women with breast cancer~   "
161016|NCT01458444|"~     The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place~     in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the~     use, in the immediate postoperative period, should lead to define the role of each technique~     and lead to a optimal rationalization of patients management with acute respiratory failure~     after surgery.~   "
161017|NCT01458431|"~     The postoperative period following cesarean is associated with moderate to severe pain that~     requires a considerable amount of analgesics that carry with them side-effects such as~     nausea, vomiting, fatigue and immobilization. Several studies have tried, with variable~     results, to find a more effective analgesia alternative such as infusion of local anesthetics~     through a catheter in the surgical wound sinus, a practice that has currently been widely~     used in clinical practice. Despite existing references on its use in the postoperative period~     following cesareans there continues to be a lack of information on other aspects. The~     investigators study hypothesis is that the use of levobupivacaine in the surgical wound will~     reduce the surface of hyperalgesia compared to the control group.~   "
161018|NCT01458418|"~     Eosinophilic Esophagitis (EE) is a condition where eosinophils (a cell that fights infection)~     travel to the esophagus (the tube through which food passes to the stomach). These cells do~     not belong there and can cause pain, soreness, difficulty swallowing and sometimes vomiting.~      Ways to treat this condition include medicine, not eating some foods, and drinking a specific~     formula (like milk) without eating any other foods. Doing these things can help fight off EE~     but these problems can come back when treatment is stopped. If EE symptoms go on for a long~     time, it can lead to the esophagus becoming narrow and feeling tight when eating and~     swallowing and surgery may be needed to widen the narrowed area to relieve the sensation of~     tightening.~      Montelukast is a medicine that fights off a type of chemical that can be a magnet for~     eosinophils. People usually take this medicine to help treat their asthma. It is not approved~     to treat EE. This medication is taken once a day.~      The purpose of this study is to see if Montelukast, compared to placebo, will help reduce the~     number of eosinophils in children with EE and help stop the tightening of the esophagus.~   "
161019|NCT01458405|"~     The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells~     (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial~     infarction.~   "
161020|NCT01458392|"~     Dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied~     in patients with squamous cell carcinoma of the head and neck (SCCHN). Dalantercept blocks~     the development of blood vessels that supply tumors.~   "
161021|NCT01458366|"~     The Phase I part of the study will apply to identify dose-limiting toxicities (DLT) and to~     define maximum-tolerated dose (MTD) for a new chemoimmunotherapy combination of bendamustine,~     ofatumumab, carboplatin, and etoposide in patients with Non Hodgkin's lymphoma whose disease~     has progressed or has recurred after prior chemotherapy.~      The Phase II part of the study will be a single-arm, open-label study in which all patients~     will receive combination bendamustine, ofatumumab, carboplatin and etoposide at the MTD dose~     defined in phase I.~      This study hopes to identify a life-prolonging therapy for patients with Non-Hodgkin's~     Lymphoma whose disease has progressed or has recurred after prior chemotherapy. The~     hypothesis is that the proposed combination of chemotherapy is well-tolerated and is~     efficacious for the treatment of relapsed/refractory aggressive B cell lymphomas.~   "
161046|NCT01458041|"~     Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb~     ischemia by recording clinical parameters.~   "
161388|NCT01453569|"~     The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is~     effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine~     the best therapeutic dose of sodium oligo-mannurarate capsule.~   "
161022|NCT01458353|"~     Despite performing colonic surgery with strict asepsia measures, minimizing the contact of~     the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In~     stapled anastomosis, the hole opened in the colon is minimum, just the necessary for~     introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen~     is more exposed to the peritoneum, despite the colonic occlusion with clamps meanwhile the~     suture is performed.~      Hypothesis: After stapled anastomoses, the peritoneal contamination should be lower than~     after handsewn ones.~   "
161023|NCT01458340|"~     The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be~     evaluated in adult males with ADHD.~   "
161024|NCT01458327|"~     This study will consist of a single session of MDMA-assisted psychotherapy with a full dose~     of MDMA for people who took part in a study of MDMA-assisted psychotherapy in people with~     posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a~     year after the first MDMA sessions. The single session will be performed by the same pair of~     therapists who performed the sessions in the first study. People will have a preparatory~     session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms~     and symptoms of depression will be measured at the start of this study and two and 12 months~     after the session.~   "
161025|NCT01458314|"~     Patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory~     insufficiency (CRI) have severe dyspnoea during exercise at low load. Physiological studies~     performed in these patients during a unique session of training have shown a positive effect~     on exercise tolerance if non-invasive mechanical ventilation (NIV) was added during~     incremental effort test or endurance. Menadue and coworkers (2009) have shown in CRI patients~     with hypercapnia, secondary to COPD or cifoscoliosis, that combination of NIV during arm~     effort test improved ability to perform the exercise. Similar result was not reached using~     NIV during walking. Further studies have underlined a positive effect of the ventilation~     therapy during exercise within specific programs of pulmonary rehabilitation (Corner 2009).~     Moreover, the addition of NIV to an exercise training (ET) program in COPD patients may~     produce greater benefits in exercise tolerance and quality of life than exercise training~     alone (Garrod 2000).~      A great improvement in health-related quality of life, functional status and gas exchange in~     COPD patients with chronic hypercapnic respiratory failure with nocturnal NIV compared with~     patients in pulmonary rehabilitation alone has been also shown by Duieverman (2008). However,~     in the same study Duieverman did not show any significant difference between groups in terms~     of tolerance to effort test.~      Aim of the study is to evaluate if application of daily NIV during physical training may~     increase the benefits of rehabilitation in CRI patients with nocturnal NIV compared with~     patients with nocturnal NIV performing training under spontaneous breathing.~   "
161026|NCT01458301|"~     The purpose of this study is to determine the efficacy and safety of TAK-385, once daily~     (QD), for 12 weeks in women with endometriosis.~   "
161027|NCT01458288|"~     This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell~     Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma,~     Non-Hodgkin Lymphoma or Hodgkin Disease.~   "
161028|NCT01458275|"~     This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group,~     efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and~     premenarchal female subjects 6 to 11 years-old diagnosed with SAR.~   "
161029|NCT01458262|"~     The purpose of this study is to determine the clinical impact of cerebral and systemic~     desaturation during liver transplantation and resection on post-operative complications.~   "
161030|NCT01458249|"~     The purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in~     subjects with soft tissue sarcoma who received at least one standard chemotherapy (an~     anthracycline or an ifosfamide monotherapy or a combination therapy).~   "
161031|NCT01458236|"~     A multinational, multicenter, double-blind, randomized, placebo-controlled, Phase III study~     to assess the efficacy and safety of BPS 314d-MR in subjects with pulmonary arterial~     hypertension currently receiving treatment with an Endothelin Receptor Antagonist (ERA)~     and/or a Phosphodiesterase-5 Inhibitor (PDE-5 inhibitor).~      Approximately 100 centers will be participating in the study. Approximately 630 eligible~     subjects will be randomized 1:1 into two groups, BPS-314d-MR (active) or placebo study drug.~   "
161032|NCT01458223|"~     Post-operative antibiotics for infection prophylaxis are routinely given to most surgical~     patients, and for orthopaedic surgery patients, the standard of care is treatment for 24~     hours following any elective procedure (1). The most concerning risk for insufficient~     antibiotic coverage in the post-operative period is the development of a complicated~     infection requiring irrigation and debridement or revision surgery. Moreover, recovery from~     surgery is usually delayed in patients that have postoperative wound infections leading to~     increased resource utilization and increased economic cost for the health care system. It is~     clear that prophylactic antibiotic therapy is necessary in the immediate post-operative~     period, but the length required continues to be debated.~      Orthopaedic patients undergoing elective spine surgeries often require the placement of a~     hemovac drain which applies gentle suction to remove excess fluid/blood and to promote~     healing. Wound drains, however, may also increase the risk of post-operative infection~     because they expose the clean interior aspect of the wound to the dirty exterior area~     around the wound. Given this additional focus of infection, it is unknown whether prolonged~     antibiotic therapy post-operatively is needed to decrease the rate of infection in this~     population (2,3). There is sparse literature evaluating the effectiveness of prolonged~     antibiotic therapy in decreasing complicated post-operative infection requiring irrigation~     and debridement in this population (1,4). To our knowledge, there are no recent studies~     comparing prophylactic antibiotics for 24 hours only post-operatively versus 24 hours after~     removal of the drain. In fact, a recent evidence-based review of the literature by the North~     American Spine Society highlighted the need for research in this area (5).~      The proposed study will compare two patient populations who will receive various lengths of~     post-operative antibiotics. One will receive only 24 hours worth, and the other will receive~     antibiotics for 72 hours after surgery and the rate of complicated infection compared between~     the two.~      The absence of a demonstrable difference suggests that antibiotic prophylaxis for only 24~     hours immediately post-operatively is sufficient for all elective spine patients undergoing~     posterior spine procedures requiring the placement of a hemovac drain.~   "
161033|NCT01458210|"~     The purpose of this study is to look at how the body processes oral contraceptive (OC), using~     Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female~     participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body.~     Information about any side effects that may occur will also be collected.~   "
161034|NCT01458197|"~     1. Primary Objective:~           To evaluate the dose-response relationship of tarafenacin on efficacy.~        2. Secondary Objectives:~             -  To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo~               in patients suffering from Overactive Bladder. .~             -  To compare the tolerability of different doses of tarafenacin to that of placebo in~               patients suffering from Overactive Bladder. .~   "
161035|NCT01458184|"~     The aim of this study is to assess the effectiveness of Telephone-Linked Care for Complex~     Patients (TLC-C) in the care of patients with complex health care needs. These are patients~     frequently transitioning from inpatient to ambulatory care with multiple chronic diseases~     that tend to lead to increased health-care utilization and other socio-economic~     vulnerabilities. The objective is to reduce preventable hospital utilization, improve quality~     of life, increase satisfaction with ambulatory care, improve disease-specific metrics, and~     reduce net payer costs.~   "
161036|NCT01458171|"~     The objective of this study is to assess the long-term safety, tolerability, and efficacy of~     IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study~     ZLB06_002CR (NCT01199705).~   "
161037|NCT01458158|"~     The purpose of this study is to determine whether matrix metalloproteinases are associated~     with atherosclerosis in the different stages of chronic kidney disease.~   "
161038|NCT01458145|"~     This is an efficacy study of an intensive home visitation intervention, Minding the Baby~     (MTB). This reflective parenting program (aimed at enhancing maternal reflective capacities),~     is focused on first-time young mothers and infants living in an urban community. The study,~     grounded in attachment and human ecology theories integrates advanced practice nursing and~     mental health care by pairing master's level nurse practitioners and social workers with~     at-risk young families. Aims of the study are: 1) to determine the efficacy of the MTB~     intervention in young mothers and infants with respect to a) maternal outcome variables~     including the quality of the mother-infant relationship, maternal reflective capacities,~     maternal mastery/self-efficacy, parental competence, and maternal health and life course~     outcomes (educational success, employment, delaying subsequent child-bearing); and b) infant~     outcome variables including early attachment, infant health, and developmental outcomes; 2)~     to monitor fidelity and dose of the program with young mothers; 3) to describe the evolution~     of reflective capacities in adolescent mothers (contrasting intervention group with control~     group) through descriptive qualitative analyses of transcribed Pregnancy Interviews and~     Parent Development Interviews at the last trimester of pregnancy and at 24 months; 4) to~     conduct cost-effectiveness analyses of the program. The longitudinal two-group study~     (subjects nested within randomly assigned groups), will include multi-method (self report,~     interview and direct observation and coding of behaviors) approaches with a cohort of~     first-time multi-ethnic mothers between the ages of 14-25 (and their infants). MTB home~     visits occur weekly for intervention families (n=69) beginning in mid pregnancy and~     continuing through the first year, and then bi-weekly through the second year. Mothers and~     infants (n=69) in the control group will receive standard prenatal, postpartum and pediatric~     primary care in one of two community health centers (as will the intervention group) and also~     receive monthly educational materials about child health and development mailed to their~     homes. Maternal and infant outcome variables will be followed over time (pregnancy, 4, 12,~     and 24 months) as well as compared between the 2 groups. Cost analyses and analysis of the~     dose and sample characteristics linked to efficacy, will allow us to plan for translation of~     the model into clinical care and community sustainability.~   "
161039|NCT01458132|"~     The World Health Organization has estimated that as many as 10% of the population worldwide~     may at some point experience at least one seizure. The percentage with active epilepsy is~     from 0.4% to 1%. From 40% to 65% of patients with HIV infection have been estimated to have~     some neurological involvement; the percentage reaches as high as 70% to 80% when post-mortem~     assessments are included. Estimates of the percentage of HIV-infected patients with seizure~     occurrence have varied widely, with one review finding a range from 2% to 20%. The highest~     percentage in this range was reported at a center that exclusively treated patients with~     neurological involvement, in India where HIV clade C subtype is predominant. Query of another~     neurology department's database determined that of the HIV-infected patients treated at the~     center, all of whom were referred for neurological symptoms, 6.1% experienced seizures.~     Underlying neurologic diseases in these patients included HIV-associated encephalopathy,~     progressive multifocal leukoencephalopathy, and toxoplasmosis. In a Spanish population, 3% of~     HIV-infected patients over a one-year study period were found to have new-onset seizures,~     which were attributed to drug toxicity in 47%, intracranial lesions in 35%, and metabolic~     derangements in 12%.~      Drug-discontinuation studies, magnetic resonance imaging studies, and animal studies have~     produced recent evidence that some antiretroviral therapies may have neurotoxic effects,~     warranting further research. Individuals who are treated with highly active antiretroviral~     therapy are at risk for immune reconstitution inflammatory syndrome (IRIS), in which immune~     recovery triggers clinical deterioration as the newly invigorated immune system reacts to~     pathogens that either represent ongoing opportunistic infection or were previously~     successfully controlled. In a population initiating combination antiretroviral therapy~     between 1999 and 2007, 0.9% developed neurological manifestations of IRIS. Seizures may occur~     as part of a neurological IRIS syndrome, such as encephalitis and toxoplasmosis.~      Two randomized, Phase 2b dose-finding studies were conducted in HIV-1 infected adults to~     compare GSK2248761 100 mg and 200 mg given once daily as part of an antiretroviral treatment~     regimen. One of the studies (SGN113399) was in subjects with prior exposure to antiretroviral~     therapy where GSK2248761 100 mg and 200 mg once daily were compared to determine the best~     dose in this population. A contemporary control arm receiving etravirine 200 mg twice daily~     was also included, and all arms included a twice-daily background therapy consisting of~     darunavir/ritonavir 600 mg/100 mg plus raltegravir 400 mg. The other study (SGN113404) was in~     treatment-naïve subjects, comparing GSK2248761 100 mg and 200 mg once daily to determine the~     best dose in this population. A contemporary control arm receiving efavirenz 600 mg once~     daily was also included, and all arms were given background therapy selected by investigators~     from either once-daily abacavir/lamivudine 600 mg/300 mg or tenofovir/emtricitabine 300~     mg/200 mg. Of a planned total population in both studies of 300 subjects, 35 were enrolled~     before the studies were terminated because of the occurrence of seizures in five subjects.~     All of the subjects who experienced seizures were enrolled into SGN113399, four randomized to~     receive 200 mg GSK2248761 and one randomized to receive 100 mg GSK2248761. There were no~     seizures in the subjects receiving GSK2248761 in study SGN113404. At the time of study~     termination, subjects had been enrolled and received GSK2248761 at 19 sites in four~     countries: France, Romania, United States, and Germany. Although potential contributory~     conditions have been identified in some cases, definitive causative factors for the seizure~     occurrence have not been established.~      The purpose of this study is to follow subjects who previously received GSK2248761 while~     enrolled in the Phase 2b studies, which were halted due to unexpected seizures. The study~     will collect data on all subjects and will be used to monitor for additional seizures as well~     as collect additional clinical data on all subjects.~   "
161040|NCT01458119|"~     This is a long term, open label study of migalastat HCl (AT1001) in subjects with Fabry~     disease who completed treatment in a previous monotherapy trial with migalastat hydrochloride~     (HCl).~   "
161041|NCT01458106|"~     The primary objective of the study is to evaluate the safety of Recombinant Coagulation~     Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with~     hemophilia A. Secondary objectives of this study in this study population are as follows: to~     evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to~     evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc~     consumption for prevention and treatment of bleeding episodes.~   "
161042|NCT01458093|"~     In colorectal cancer screening era a huge burden of medical resources has been applied to~     surveillance. Although the adherence to post-polipectomy recommendations is a advocated as a~     mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of~     surveillance are lacking.~      The aim of present study was to evaluate the percentage of subjects in which timing of~     surveillance colonoscopy in practice agrees with that recommended by guidelines and to~     identify factors associated to the appropriateness of surveillance.~   "
161043|NCT01458080|"~     Hepatitis C Virus (HCV) is a leading cause of chronic liver disease (CLD) worldwide. Current~     mainstay of treatment is combination therapy with pegylated interferon and ribavarin.~     Thrombocytopenia as a treatment related adverse event or a complication of chronic liver~     disease often necessitates dose reduction and discontinuation in these patients.~     Revolade®/Promacta® (eltrombopag) is an oral second generation thrombopoietic growth factor~     in development for the treatment thrombocytopenia associated with various conditions,~     including secondary thrombocytopenia related to CLD and hepatitis C. In 2009 a phase III~     trial for CLD patients undergoing an elective invasive procedure (ELEVATE) was terminated~     early due to an imbalance of thromboembolic events (TEE) between the placebo and the~     eltrombopag arm. Currently, two global interventional Phase III trials (ENABLE 1 and ENABLE~     2) are being conducted in approximately 1500 patients to evaluate the efficacy of eltrombopag~     in enabling HCV patients to achieve sustained viral response. Due to the similarities between~     the patient groups in ELEVATE and ENABLE, there is a concern that invasive procedures may~     influence the risk of TEE in the ENABLE population. This observational, non-interventional,~     retrospective, multicentre, nested case-control study will collect data from chart~     abstraction and medical record review to augment data from the ENABLE case report forms~     particularly with regards to invasive procedures. The study population includes cases and~     controls drawn from the ~1500 participants of the ENABLE trials. All eligible cases of TEE~     will be included in the study as cases. All other patients who participated in the ENABLE~     trials and did not experience a TEE, will be eligible to be selected as controls. Case report~     forms will be developed to enable standardized data capture. The Sponsor has contracted with~     the Clinical Research Organization, Outcome Sciences Inc to manage the study. ENABLE~     investigators will work with Outcome staff to obtain relevant information from the treating~     physician (e.g. surgeon) and the facility where the invasive procedure was performed~     (pre-operative tests, peri-operative course, diagnostic testing for TEE). Single point~     abstraction will be performed to obtain data from the medical record and from any additional~     data resources obtained by the investigator (e.g., operative note, anesthesia record).~     Analyses will be conducted using logistic regression models to estimate the risks. The~     primary objective of the study is to evaluate if there is an increased risk for TEE among~     patients who had an invasive procedure while exposed to eltrombopag (during the ENABLE~     trials).~   "
161044|NCT01458067|"~     The study consists of a pre-screening period to determine if the subject's tumor has PTEN~     deficiencies. Subjects then continue into the screening phase for Part 1, 2, or 3, as~     appropriate. In Part 1, subjects will then receive a single dose of 25 mg. After analysis of~     24 hour pharmacokinetic (PK) samples, subjects may receive continuous dosing or receive a~     single modified dose. In Part 2, subjects will be enrolled and dose escalation will occur in~     a 3+3 design. Subjects will receive a single dose on Day 1, and then begin continuous daily~     dosing after collection of a 72-hour PK sample. Additional subjects may be enrolled at lower~     dose levels for assessment of pharmacodynamic response. In Part 3, up to two tumor-specific~     expansion cohorts will be enrolled and receive the MTD or BED as defined in Part 2. A minimum~     of 12 and a maximum of 20 evaluable subjects will be enrolled in each cohort. Interim~     monitoring for futility will be incorporated after response data from 12 subjects are~     available. In addition, up to 20 evaluable subjects will be enrolled into Part 3~     -Signal-finding Expansion Cohort at the MTD or BED as defined in Part 2. All subjects in all~     parts/cohorts will receive daily dosing until withdrawal or unacceptable toxicity. All~     subjects in all parts/cohorts will receive daily dosing until withdrawal or unacceptable~     toxicity.~   "
161045|NCT01458054|"~     This study is a Phase I open label drug interaction study to evaluate the effect of~     omeprazole and ritonavir on GSK2336805.~   "
161047|NCT01458028|"~     Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy~     subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in~     blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will~     be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days.~     The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the~     5 days of the study.~   "
161048|NCT01458015|"~     The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e.~     reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain~     signs and symptoms in comparison to oxycodone.~   "
161049|NCT01458002|"~     This study targets two major risk factors for cancer; is designed to treat the behaviors on a~     population basis, using proactive recruitment strategies; intervenes on multiple behaviors~     simultaneously, thereby producing greater impacts for cancer prevention; utilizes one of the~     most promising approaches to low cost population based interventions for health-related~     behavior change, namely the internet; and develops and tests a promising new approach to~     increasing the utilization and effectiveness of internet-based interventions, relational~     agents. The primary aims are: (1) To develop and assess the effectiveness of a tailored~     internet intervention on a national sample; (2) To develop and assess the effectiveness of~     the internet intervention enhanced by a relational agent; and (3) To determine if the~     intervention with the relational agent can outperform the regular tailored internet~     intervention.~   "
161050|NCT01457989|"~     The objective of this meta-analysis is to provide data on long-term safety and efficacy~     following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion~     for retigabine using pooled data from ongoing open-label extension (OLE) Studies~     VRX-RET-E22-303 and VRX-RET-E22-304.~   "
161051|NCT01457976|"~     The study concerns a survey of attitudes of the public on issues around personal~     responsibility for health and the use of financial incentives to promote health in the U.S.~     and Germany. All data are gathered anonymously through online platforms. Two separate~     professional panel providers are used for access to members of the public. All participants~     are people who have voluntarily joined a survey panel in the past through an informed consent~     process and currently serve as panel members.~   "
161052|NCT01457963|"~     The primary objective of this study was to estimate the prevalence of PE among consecutive~     ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent~     injection, regardless of whether PE was suspected clinically. The secondary objectives were~     to assess the association between PE and DVT, to identify risk factors for VTE, and to~     determine the outcome of VTE.~   "
161053|NCT01457950|"~     The purpose of this study is to determine if denosumab is effective in increasing bone~     mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.~   "
161054|NCT01457937|"~     The cohort of post-menopausal women represents a group of very-difficult-to-treat patients in~     whom a more powerful approach is required in order to improve the disappointing response~     rate. Thus the addition, in patients with previous failure to PEG/RBV treatment or in naïve~     patients, of a powerful drug like Boceprevir could greatly improve SVR rate as suggested by~     the results of SPRINT_2 trial in whom Boceprevir addition determined a 30% improvement in SVR~     rate in difficult gt 1 patients of African descent versus standard PEG IFN/Ribavirin therapy~     or by those of RESPOND-2 that showed the same percent improvement of RGT-retreatment with~     Boc/P/R of previous failure of standard therapy.~      Goal of the study is to verify whether the addition of a 24-week treatment with boceprevir to~     standard antiviral therapy with Peg IFN and ribavirin will increase the rate of SVR in~     patients difficult to treat, such as HCV-positive women in post-menopausal women with~     genotype 1, not only those who have never been treated, but also in those who have not~     responded to previous treatment with peginterferon and ribavirin (Riba).~   "
161055|NCT01457924|"~     Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that~     specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which~     expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid~     immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that~     targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse~     rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both~     well tolerated and efficacious in several indications, including a small, placebo-controlled~     trial in RRMS using an intravenous (IV) formulation.~      This double-blind, placebo-controlled, parallel-group study will investigate the safety and~     efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS.~     The primary objective of the study is to investigate the efficacy as assessed by magnetic~     resonance imaging. Other objectives will include evaluation of tolerability/safety,~     dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as~     other clinical endpoints.~   "
161056|NCT01457911|"~     Primary Objective:~        -  To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL~          M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as~          reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes~          mellitus (T2DM) inadequately controlled with metformin.~      Secondary Objectives:~        -  To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5% of fixed dose~          combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison~          with glimepiride (AMARYL) alone at week 20.~        -  To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of~          glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL)~          alone at week 20.~        -  To assess the safety and tolerability of fixed dose combination of glimepiride and~          metformin (AMARYL M 1/250mg).~   "
161057|NCT01457898|"~     Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac~     patients but more studies are necessary to clarify its respiratory and hemodynamic effects.~     Therefore, the investigators objective was to study its effects in the oxygenation index~     (PaO2/FiO2) and in hemodynamic variables in this group of patients.~   "
161103|NCT01457300|"~     The Outcome of Multi-Disciplinary, Structured Rehabilitation of Older People in a District~     Inpatient Rehabilitation Centre is better than in a Standard Primary Health Care~     Rehabilitation Programme in Short Term Beds in Nursing Homes.~   "
161058|NCT01457885|"~     Although transplant results for AML in complete remission (CR) at the time of transplant have~     improved, transplant results for non-remission AML have been quite poor. Most multi-center~     studies have focused on standard risk AML patients and not many studies have been done in~     this population of patients with non-remission AML. There are a large number of older~     patients with non-remission AML because the complete remission rate with induction~     chemotherapy decreases with age. Such older patients do not tolerate conventional full~     intensity conditioning regimens. Thus, an effective and tolerable conditioning regimen for~     non-remission AML is a great unmet need for current transplant practice.~      From the investigators earlier study, it is suggested that replacing Fludarabine of standard~     FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in~     the transplant conditioning regimen may potentiate the anti-tumor activity of the~     conditioning regimen without adding significant toxicity, a goal of new conditioning regimen~     development.~      The investigators expect to enroll a total of 75 patients from about fifteen sites. The~     investigators main objective is to confirm both the safety and efficacy as measured by~     one-year overall survival, of the CloBu4 combination as full intensity conditioning for~     non-remission acute myelogenous leukemia.~   "
161059|NCT01457872|"~     This study aims to study and implement active referral of heroin users from a syringe~     exchange programme to evidence-based treatment for heroin addiction. Patients are randomized~     to either a strength-based case management intervention or a control group, while both groups~     receive referral to medical investigation for inclusion in substitution treatment for heroin~     addiction. The hypothesis is that syringe exchange can be used for referral to effective~     treatment, and that a strength-based intervention can increase the number of patients who are~     successfully referred and enter treatment.~   "
161060|NCT01457859|"~     The purpose of this study is to assess whether triclosan-coated sutures reduces wound~     infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG~     patients.~   "
161061|NCT01457846|"~     The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547~     compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose~     tumours are found to have FGFR2 polysomy or gene amplification.~   "
161062|NCT01457833|"~     Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in~     the same way following either implantation of endobronchial valves or intrabronchial valves.~   "
161063|NCT01457820|"~     Allopurinol is a drug commonly used to treat gout. However recent studies have shown it has~     the potential to help improve oxygen supply to heart muscle. In this study the Investigators~     aim to find out if allopurinol slows down the onset of angina symptoms, as seen by a doctor~     on a tracing of the heart (ECG- electrocardiogram), for patients who have been diagnosed with~     heart disease, when exercising on a treadmill. The Investigators are also are trying to~     figure out the best dose of allopurinol to use and to see how quickly it begins working. To~     do this the investigators will recruit patients with angina, exercise them on a treadmill~     after giving different doses of allopurinol and see if there is an improvement in their time~     to bring on angina symptoms and signs. Patients recruited to this trial will receive three~     different treatment regimes over a six week period. Each treatment regime will last for one~     week with a one week rest period between each regime. This will involve up to eleven visits~     to Ninewells Medical School, Dundee for testing.~   "
161064|NCT01457807|"~     To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new,~     different extended release formulations of tablets of AZD3241 (300 mg), in relation to the~     100 mg extended release tablet used in a previous study and potential food interaction. The~     safety and tolerability of AZD 3241 will also be investigated as a secondary objective. In~     addition to these a number of exploratory objectives will be investigated with blood~     sampling.~   "
161065|NCT01457794|"~     The aim of this randomized crossover study, is to investigate the effect of school meals~     based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep~     quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes~     and osteoporosis in 8-11 year old Danish school children.~      The participating 3rd and 4th grades on 9 selected primary schools will be randomized to~     either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual~     school lunch for 3 mo and then crossover for additional 3 mo. All participants will be~     examined three times; at baseline, after 3 mo and after 6 mo.~   "
161066|NCT01457781|"~     This is a Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine~     Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as~     Add-on Therapy in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH).~   "
161067|NCT01457768|"~     This Registry is designed to obtain long term data on participants who have failed to achieve~     sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent~     (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.~   "
161068|NCT01457755|"~     This Registry is designed to provide long term clinical and virologic follow up in~     participants who have achieved sustained virologic response (SVR) while participating in a~     previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is~     observational and no treatment is provided for HCV.~   "
161069|NCT01457742|"~     The purpose of this study is to determine the effectiveness of non-thermal Pulsed Radio~     Frequency (PRF) treatment with the Ivivi SofPulse for amelioration of knee pain in patients~     with mild to moderate Osteoarthritis and to determine the duration of clinical benefit~     following discontinuation of treatment.~   "
161070|NCT01457729|"~     Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard~     bike ergometer which is additionally equipped with a system to gather training data and the~     ability to send daily training time to an internet server to which the physician has access.~     Training time of two groups is compared. Group one is not motivated while group two benefits~     from telephone feedback when training time declines. It is presumed that training time~     increases with better information and response to training behaviour.~   "
161071|NCT01457716|"~     The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and~     Formoterol after administration of 3 different product variants of Budesonide/Formoterol~     Easyhalers and Symbicort turbuhaler.~   "
161072|NCT01457703|"~     The purpose of this study is to determine why obese women have lower hormone levels and less~     fertility than women of normal body weight. The proposal will examine the reproductive system~     at the level of the brain and the ovary to define the changes that happen leading to lowered~     hormone production. Women will be studied throughout a menstrual cycle and given medications~     that will test how well their pituitary gland can make hormones that stimulate the ovary~     (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a~     medication to abolish estrogen production in the body and their response to this medication~     will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will~     be examined.~      --Hypotheses:~        1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing~          hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese~          compared to normal weight women)~        2. Obese women have abnormally increased sensitivity to estradiol negative feedback which~          will be reversed by an aromatase inhibitor. (comparative study of obese compared to~          normal weight women)~   "
161073|NCT01457690|"~     To evaluate the kinetics of intestinal absorption of vitamin E water-soluble form from the~     classical lipid-soluble form in a population of patients with intestinal malabsorption~     (hypocholesterolemias family by retention of chylomicrons).~   "
161074|NCT01457677|"~     This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will~     investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major~     depressive disorder having inadequate response to ongoing antidepressant treatment. Patients~     will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching~     placebo. The anticipated time on study treatment is 6 weeks.~   "
161075|NCT01457664|"~     This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in~     healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of~     RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.~   "
161076|NCT01457651|"~     The risk of respiratory failure after cardiac surgery is high, and it may result in many~     complications. The maneuver of alveolar recruitment may improve the oxygen transport in the~     human organism. The investigators compare three different types of alveolar recruitment in~     patient after cardiac surgery, to reveal which one is better.~   "
161077|NCT01457638|"~     The purpose of this study is to determine whether inferior turbinate surgery during~     rhinoseptoplasty is effective in improving quality of life and acoustic rhinometry outcomes.~   "
161078|NCT01457625|"~     Background Fetuin A, synthesized in hepatocyte, is a circulatory inhibitor of precipitation~     of calcium and phosphate and links to cardiovascular calcification and mortality in dialysis~     patients; besides, it is associated with insulin resistance in general population. Hepatic~     fat accumulation enhanced fetuin A secretion in animal model.~      Objects This study is designed to investigate the association of fetuin A level, insulin~     resistance and hepatic fat content in dialysis patients. Besides, we planed to observe the~     survival of dialysis patient with different hepatic fat content.~      Methods. This is a prospective observational study. Three hundred and fifty ESRD patients~     undergoing maintenance HD or PD will be recruited for this prospective investigation. All the~     participants will receive baseline abdominal ultrasound for estimation of hepatic fat~     content. Hepatic fat content will be estimated as minimal, mild, moderate or severe according~     to the Hepburn classification. Besides, all participants also check baseline fetuin A,~     HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C),~     nutritional parameter and other biochemical parameters. All participants will be followed for~     4 years for survival analysis. The outcomes are all-cause mortality and composite CV~     mortality.~      Expected results Dialysis patients with higher hepatic fat may have higher fetuin A levels~     which may lead to long-term survival benefits.~   "
161079|NCT01457612|"~     The primary study objective is to investigate the potential chronic beneficial effect of~     polyphenolics derived from strawberry on impaired insulin signaling in insulin resistant~     individuals through their ability to modulate oxidative- and inflammatory-markers that lead~     to devastating disease, including, but not limited to, diabetes and cardiovascular disease.~   "
161080|NCT01457599|"~     The aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic~     metastases after complete response to a neoadjuvant chemotherapy.Primary the investigators~     want to investigate if the wire marking is a possibility to mark respectively to identify~     these lesions. Further the investigators want to evaluate how many patients with complete~     radiologic have complete histologic response in their specimen respectively in how many~     specimens in the definitive histology tumor cells are visible.~   "
161081|NCT01457586|"~     Observational Study of Hemoderivative Transfusion Imputable Complications in Initial~     Uncomplicated Heart Surgery. Inclusion criteria are patients who discontinued the mechanical~     ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs~     up to the beginning of the second postoperative day.~      Blood transfusion might be only a marker of the patient severity.~   "
161082|NCT01457573|"~     A single center, pilot trial using tamsulosin and solifenacin in 10 men with symptomatic~     lower urinary tract symptoms (LUTS). Subjects will be evaluated at baseline, 1, 2, and 3~     months for urinary NGF, urine creatinine, NGF/CR ratio and patient reported outcomes through~     questionnaires.~   "
161083|NCT01457560|"~     This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK)~     Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix~     hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of~     DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.~   "
161084|NCT01457547|"~     The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and~     HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.~   "
161149|NCT01456676|"~     The purpose of this study is to determine the feasibility of administering the combination of~     nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid~     leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose~     level (RP2D) of LDE225 in combination with nilotinib.~   "
161150|NCT01456663|"~     This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe~     hepatic impairment compared with healthy control subjects.~   "
161085|NCT01457534|"~     Background. Acute renal failure after liver transplantation (LT) requiring continuous renal~     replacement therapy (CRRT) adversely affects patient survival. However, there are few reports~     to assess the predictors for postoperative CRRT in liver transplant patients. The~     investigators undertook this study to identify perioperative factors that would predict~     patients at risk of CRRT.~      Patients and Methods. The investigators retrospectively reviewed the data of 148 liver~     transplant patients from January 2007 to November 2010 at Severance Hospital, Yonsei~     University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44 (18~     patients from living and 26 from deceased donors) and those without CRRT was 104. Univariate~     and stepwise logistic multivariate analyses were performed.~   "
161086|NCT01457521|"~     This trial will compare two oral analgesic regimens in women undergoing first trimester~     medical abortion with mifepristone and misoprostol. The primary study outcome is pain.~   "
161087|NCT01457508|"~     This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals'~     (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate~     administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at~     3, 5 and 11 (or 12) months of age.~   "
161088|NCT01457495|"~     This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly~     SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the~     separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines~     administered at 3 and 5 months of age.~   "
161089|NCT01457482|"~     Earlier research has shown that pregnant women with a pronounced fear of childbirth have a~     significantly increased risk for birth complications and subsequent psychological trauma. In~     Sweden and also internationally, women in fear of childbirth are treated in many differing~     ways. Evidence for best care for these women is lacking. The Art Therapy method is a~     creative, psycho-therapeutic form of treatment which has been used for several decades within~     psychiatry. It has recently been seen that the Art Therapy method has positive effects during~     treatment for crisis reactions.~      Recruitment has recently been initiated for a randomized controlled study of Art Therapy for~     the treatment of fear of childbirth.~      The hypothesis for the study is as follows:~      H1 = treatment with Art Therapy and therapeutic conversations will result in a decrease in~     fear of childbirth when compared to treatment by therapeutic conversations only.~      The instrument which is to be used for measurement of childbirth fear is the Wijma Delivery~     Expectancy Questionnaire (W-DEQ). This is a well validated instrument which was developed in~     Sweden. A power calculation has shown a need for 62 x 2 participants; a total of 124 women.~   "
161090|NCT01457469|"~     This randomized clinical trial studies enhanced quitline intervention in smoking cessation~     for patients with non-metastatic lung cancer. Stop-smoking plans suggested by doctors may~     help patients with early-stage cancer quit smoking~   "
161091|NCT01457456|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Morquio~     disease from plasma~   "
161092|NCT01457443|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Pompe~     disease from plasma.~   "
161093|NCT01457430|"~     The investigators propose a study to evaluate the safety, local tolerability, convenience,~     and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary~     angioedema. The investigators believe that self administration with Icatibant for treatment~     of an acute attack of angioedema will not change the time to complete or near complete~     resolution of symptoms compared to treatment with Icatibant in a medical facility.~   "
161094|NCT01457417|"~     The purpose of this trial is to characterize the safety and toxicity of DKN-01 by determining~     a maximum-tolerated dose and associated dose limiting toxicity. To evaluate the~     pharmacodynamic response in patients with cancer. To characterize the pharmacokinetic~     parameters of DKN-01 in cancer patients who are intolerant to standard/approved therapies.~   "
161095|NCT01457404|"~     The purpose of this study is to assess the safety and practicality, feasibility and efficacy~     of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans~     population, as delivered by routine clinicians at the Veterans Affairs.~   "
161096|NCT01457391|"~     The purpose of this phase of the study is to assess the efficacy of CBT for PTSD, as~     delivered by routine addiction counselors in community treatment programs, and to compare CBT~     for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on the~     primary outcomes.~   "
161097|NCT01457378|"~     The aim of this study performed in Irritable Bowel Syndrome (IBS) subjects and healthy~     patients is to demonstrate the ability of composite score of frequency of gastrointestinal~     symptoms to discriminate healthy subjects and IBS patients. The properties of this~     questionnaire of composite score of gastrointestinal symptoms frequency will be compared to~     other validated questionnaires (severity of IBS symptoms and HRQoL).~   "
161098|NCT01457365|"~     Vitamin D insufficiency and deficiency is pandemic in the world.Sichuan Basin has a~     subtropical monsoon climate with China's lowest sunshine totals. Inferably, the prevalence of~     vitamin D insufficiency/deficiency in Sichuan basin is high, and possibly the highest in~     China. This study will research the serum 25OHD level to get the prevalence of vitamin D~     deficiency and insufficiency of urban and rural residents in Sichuan Province, China.~   "
161099|NCT01457352|"~     The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in~     the treatment of spasticity.~   "
161100|NCT01457339|"~     This is a multiple ascending dose study; the purpose of this study is to examine the safety,~     tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic~     Patients who are currently maintained on a stable dose of an antipsychotic medication.~   "
161101|NCT01457326|"~     The purpose of this prospective study is evaluate the effect of a standardized early weight~     bearing physical therapy protocol that utilizes immersion therapy on the clinical outcomes of~     lower extremity periarticular fractures. The investigators null hypothesis is that the early~     weight bearing protocol will have the same effect as a traditional 10-week non-weight bearing~     protocol on clinical outcomes.~   "
161102|NCT01457313|"~     postoperative pain and analgesic consumption between the first and the second surgery would~     be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA).~   "
161104|NCT01457287|"~     This is a prospective, longitudinal, controlled study of cognitive function and fatigue in~     patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In~     addition to following each patient over time (i.e. acting as their own control), a separate~     control group will consist of patients with early stage CRC (Stage A or B) who have had~     surgical resection of their tumour, but who do not require adjuvant chemotherapy, or patients~     with stage C CRC who have declined chemotherapy.~      Also included is a smaller sub-study of patients with limited metastatic CRC who are treated~     with more toxic chemotherapy~      To compare changes in cognitive function, as compared to baseline assessment, of patients~     with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive~     function are the High Sensitivity Cognitive Screen (HSCS) & Coghealth™.~   "
161105|NCT01457274|"~     In this trial, patients undergoing elective colonoscopy under sedation will be randomised to~     BIS-guided sedation targeting either light (bispectral index [BIS] 70-80) or deep~     (BIS<60) sedation. Sedation will be achieved with a standardised regimen of target-controlled~     infusion of propofol and fentanyl bolus. The primary end point will be the incidence of~     procedure recall in each group - this will be assessed at the conclusion of the procedure.~     The procedural conditions, cardio-respiratory complications and recovery including cognitive~     function will be assessed during and immediately after the procedure. The incidence of~     dreaming and patient satisfaction with anaesthesia care will be recorded immediately after~     the procedure. The study will be complete when the patient leaves the hospital on the day of~     the procedure.~   "
161106|NCT01457261|"~     Idiopathic pulmonary fibrosis is a relentlessly progressive disease that is responsible for~     the deaths of over 5000 people in the UK each year. At present, despite a dramatic increase~     in clinical trials in the last decade, there are no licensed treatments for IPF. The~     pathogenesis of the condition remains incompletely understood, nonetheless there is good~     evidence to suggests that the condition arises as the consequence of an aberrant wound~     healing response in genetically susceptible individuals. Basic science research into IPF has~     identified a wide range of potential treatment targets. However, in many cases developing~     compounds to act against these targets, because of their role in normal wound healing, is~     limited by the possibility of major systemic side effects.~      The lung is highly amenable to topical therapy in the form of inhaled drug preparations and~     this route is utilised in the treatment of the majority of respiratory disease. The inhaled~     route offers a number of important potential advantages for administration of therapy to~     patients with IPF. Firstly, by limiting systemic exposure to drugs, the inhaled route offers~     the potential for achieving higher lung doses of drugs that might otherwise cause systemic~     toxicity. Secondly, inhaled treatment may more effectively reach the areas of abnormality in~     IPF, namely the hyperplastic epithelium and the underlying fibroblastic foci. Thirdly, the~     inhaled route offers an alternative to parenteral administration of compounds that are poorly~     absorbed through the gastro-intestinal tract e.g. monoclonal antibodies. It should be noted~     however, that the fibrosis in IPF develops peripherally involving the alveolar interstitium~     and the terminal bronchioles. Furthermore, the disease causes architectural destruction and~     distortion of the lung that is liable to alter the normal laminar flow of air (and inhaled~     particles) through the bronchial tree. It is therefore, by no means certain that it is~     possible to deliver inhaled therapies directly to regions of fibrosis in IPF.~      The feasibility of delivering inhaled drugs in IPF has not been previously studied. This~     research by assessing the effect of particle size on inhaled particle deposition and by~     relating to this the pharmacokinetic profile of salbutamol aims to validate the potential of~     the inhaled route in IPF. This study is an important precursor to the development of specific~     topical therapies for patients with IPF.~   "
161107|NCT01457248|"~     The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental~     lung model, endotracheal tube with taper-shaped cuff has been shown to decrease~     microaspiration. This effect has never been demonstrated in patients. The investigators~     hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of~     postoperative pneumonia in patients after aortic surgery.~   "
161108|NCT01457235|"~     Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive~     function and coping skills. Several studies have recently demonstrated that CR improves~     cognitive and occupational function in patients with schizophrenia and with depression (e.g.~     Wykes et al 2007, Elgamal et al 2007). However, it is unclear whether CR improves cognitive~     and socio-occupational function in individuals with bipolar disorder (BD) and, if so, what~     impact this might have on these people's abilities in terms of work, coping strategies,~     quality of life, and everyday safety.~      The aim of the present PhD study is to investigate if CR has beneficial effects on cognitive~     and socio-occupational function in patients with previous mania and depression who experience~     persistent cognitive difficulties. Such effects would suggest implementation of CR in future~     treatment of bipolar disorder in order to facilitate the patients' ability to cope with the~     responsibilities related to work and everyday life. The hypotheses of the present study are~     that CR (in comparison to standard treatment) will 1) improve verbal learning and recall; and~     2) improve sustained attention, executive function and psychosocial function.~   "
161109|NCT01457222|"~     The purpose of this study is to determine whether mindfulness is useful as primary prevention~     for psychological health in highschool students, primarily related to stress, and whether~     mindfulness can improve cognitive function.~   "
161110|NCT01457209|"~     The central hypothesis is that acupuncture break the vicious circle of androgen excess and~     reverse insulin resistance and improve health related quality of life and affective symptoms~     in overweight and obese women with and without Polycystic Ovary Syndrome.~   "
161111|NCT01457196|"~     The primary objective of this specimen correlative study is two-fold: to provide a mechanism~     for the association of known molecular alterations with clinical outcomes, and to provide~     rapid genetic profiling of alterations with known clinical utility using tumor and germline~     specimens to support treatment decisions.~   "
161112|NCT01457183|"~     This study evaluates how subjects with intact skin tolerate a water jet (psi 10-12) and how~     well the water stream is contained by a new containment device.~   "
161113|NCT01457170|"~     The purpose of this study is to determine the effects of Apelin on the lung circulation. The~     investigators hypothesise that Apelin will relax the lung blood vessels and improve the~     pumping ability of the heart.~   "
161114|NCT01457144|"~     Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and~     Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or~     refuse receive conditioning regimen followed by autograft.~   "
161151|NCT01456650|"~     The objective of the study is to know if the R230C and C230C variants of the ATP-binding~     cassette transporter A1 (ABCA1) gene are associated with a smaller glucose lowering effect~     compared to the wild type allele (R230R) in patients with type 2 diabetes.~   "
161389|NCT01453556|"~     Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in~     laparoscopic right colectomy reduces post-operative bowel canalisation time and length of~     stay in comparison with extracorporeal mechanical anastomosis.~   "
161115|NCT01457131|"~     Background:~      - A new cancer treatment involves collecting white blood cells from an individual, modifying~     them to secrete IL-2 and target the ESO-1 protein expressed on some cancers, and returning~     them to the body. The cells may then be able to seek out the cancer cells and destroy them.~     Some kinds of cancer contain a protein called ESO-1, which is found on the surface of the~     cells. Doctors want to modify white blood cells to have an anti-ESO-1 effect, and use them to~     treat the cancer that has the ESO-1. In addition to adding genes that target the ESO-1~     protein to the cells, the genes for IL-12 are added to the cells. IL-12 is a protein that~     stimulates the immune system. This type of therapy is called gene transfer.~      Objectives:~      - To test the safety and effectiveness of anti-ESO-1/IL-12 white blood cells against~     metastatic cancer.~      Eligibility:~      - Individuals at least 18 years of age who have metastatic cancer that expresses ESO-1 and~     has not responded to standard treatments.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests and imaging studies.~        -  Participants will have leukapheresis about a month before the treatment to collect white~          blood cells.~        -  They will have chemotherapy 5 days before the treatment to suppress the immune system,~          and prepare the body for the anti-ESO-1/IL-12 cells.~        -  The anti-ESO-1/IL-12 cells will be given as an infusion.~        -  Participants will be monitored in the hospital during their recovery from the treatment.~        -  Participants will have regular followup exams every 1 to 6 months. The exams will~          include blood tests, imaging studies, and other studies.~      Due to toxicities seen with the regimen, it was decided not to pursue the phase 2 portion of~     the study.~   "
161116|NCT01457118|"~     The study objective of this open label, multicenter study is to provide access to NKTR-102~     treatment to subjects previously enrolled in a NKTR-102 study who are without signs of~     disease progression since receiving NKTR-102.~      In addition the study will evaluate the safety of continued exposure to NKTR-102, observe~     disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy~     of NKTR-102 in subjects with advanced or metastatic solid tumors.~   "
161117|NCT01457105|"~     self-expandable metal stents for palliation of malignant biliary strictures~   "
161118|NCT01457092|"~     The purpose of the study was to analyze the resolution rate of benign biliary strictures due~     to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully~     covered self-expandable metal stents.~   "
161119|NCT01457079|"~     Radiation therapy has been, and is being used in treatment of patients with keloid. Radiation~     is typically used as an adjunct to surgery in order to reduce the recurrence rate of keloid.~      Radiation therapy is not free of long term side effects. Radiation Therapy is known to cause~     secondary cancers. The investigators also do not have a good understanding as to how~     effective radiation therapy is in preventing recurrence of keloid.~      Purposes of this study are to determine the long term safety as well as efficacy of radiation~     therapy when used for treatment of keloid.~   "
161120|NCT01457066|"~     The goal of this proposal is to culturally adapt and tailor an existing, theory-based~     intervention, using state-of-the-art methods designed to maximize cultural sensitivity,~     feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized~     controlled trial (n=60 intervention; n=60 control).~   "
161121|NCT01457053|"~     The purpose of this research study is to compare the effects (good and bad) of~     ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy~     (furosemide, torsemide, bumetanide) on your heart function and blood flow.~   "
161122|NCT01457040|"~     Evolving paradigms in the treatment of adult ALL include the application of intense pediatric~     regimens to the treatment of adolescents and young adults (AYA) and the optimization of~     allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the cure of patients. The~     Cancer and Leukemia Group B (CALGB) and the Children's Cancer Group (CCG) first asked whether~     AYA between the ages of 16 and 20 fared differently whether they were treated on pediatric~     protocols. The results of this study demonstrated that although the complete remission rates~     were identical for the AYAs treated on the CALGB and CCG trials, the AYAs had a 63%~     event-free survival (EFS) and 67% OS at 7 years on the CCG trials compared with 34% and 46%,~     respectively, on the CALGB trials.~      High relapse and transplantation-related-mortality still remains great challenge for HSCT of~     adult ALL, which both range between 25% and 30%. Recently, risk-adapted indication and~     optimization of conditioning regimen are highlighted, which aiming to reduce TRM and relapse~     rate, respectively.City of Hope National Medical Center studied the substitution of etoposide~     (VP-16) for CY in the treatment of ALL patients receiving HCT. The result suggested that~     etoposide and TBI are associated with a decreased relapse rate following transplantation for~     ALL, compared with those receiving CY and TBI. Japanese and Germany reports pronounced the~     advantage of VP-16 in intensified regimen for adult ALL. On the same time, the investigators~     previous researches have confirmed the effect and safety of FA-intensified conditioning~     regimen on relapse and refractary leukemia.~      Based on mentioned above, the investigators speculate that VP-16-intensified conditioning~     regimen could improve the outcome for adult ALL. The potential mechanism will be attributed~     to reduce MRD and promote GVL effect via providing enough time-window for~     immuno-reconstitution by high-dose preparative regimen.~   "
161123|NCT01457027|"~     A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V~     according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine~     strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine~     strains and to assess the cross-protection against 4 selected circulating heterogeneous~     A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.~   "
161124|NCT01457014|"~     The purpose of this study is to evaluate positive pressure in patients with chronic pain~     taking opioid medications who have sleep disordered breathing.~   "
161125|NCT01457001|"~     Multicentric randomized Italian clinical trial, open label, not for profit. To evaluate the~     efficacy of 25-OH-D vitamin in terms of myocardial infarction, stroke, sudden death, death~     for other causes in chronic haemodialysis patients. Two arms of treatment: 25-OH-D vitamin~     per os versus no treatment.~   "
161126|NCT01456975|"~     The investigators expect that the using of prothesis with sinuses has more benefits for long~     term competence and condition of aortic valve than the using of straight prothesis.~   "
161152|NCT01456637|"~     The object of this study is to determine whether feedback added to a self-help protocol for~     insomnia enhances the treatment effect. In this study all participants receive an online~     self-help cognitive behavioral therapy (CBT) intervention consisting of information~     (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with~     insomnia will be invited via a popular scientific website to fill out online questionnaires.~     Half of the participants will received by e-mail from a therapist, the other half of the~     participants will do the intervention without feedback. Participants will be measured 4, 16,~     and 40 weeks after intervention with the same questionnaires.~   "
161127|NCT01456962|"~     Increases in cluster of differentiation 4 (CD4)+ T cells in the blood is well documented in~     human immunodeficiency virus (HIV)-infected individuals after starting antiretroviral therapy~     (ART), but increases CD4+ T cells in the cervix is variable and not fully understood.~     Although the amount of HIV in the vagina declines in parallel with those in the plasma when~     antiretroviral therapy for HIV is started, HIV is still detected frequently in cervical~     samples from women with undetectable plasma viral loads, suggesting that low level viral~     replication in the female vaginal tract could lead to both inflammation and incomplete~     increases in CD4+ T cells. Two classes of HIV medications, nonnucleoside analogue reverse~     transcriptase inhibitors and protease inhibitors are substantially lower in the female~     genital tract compared to plasma, whereas concentrations of another class, nucleos(t)ide~     analogue reverse transcriptase inhibitors are similar or higher to those found in plasma.~     Thus, many widely used first-line three drug HIV therapies only achieve high concentrations~     of only two medications in the female genital tract. Importantly, with the recent development~     of raltegravir (RAL), which achieves concentrations in the female genital tract higher than~     those in plasma, ART regimens that deliver high concentrations of 3 antiretroviral drugs to~     the female genital tract are now available. The investigators hypothesize that cervical CD4+~     T cell reconstitution is better and inflammatory markers are lower in HIV-infected women on a~     HIV-therapy including tenofovir (TDF) and emtricitabine (FTC) with RAL versus ritonavir~     (RIT)-boosted atazanavir (ATZ), and that this is due to therapeutic concentrations of 3~     versus 2 antiretroviral drugs in the female genital tract.~   "
161128|NCT01456949|"~     The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm,~     controlled,unblinded clinical study designed to provide long-term safety and effectiveness of~     the Arctic Front® Cardiac CryoAblation System.~   "
161129|NCT01456936|"~     This study is being conducted to assess varenicline and bupropion as aids to smoking~     cessation treatment in subjects with and without an established diagnosis of major~     psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified~     adverse events (AEs) in both of these populations).~   "
161130|NCT01456923|"~     Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy~     combined with surgery in colorectal cancer (CRC) avoiding surgery complications.~   "
161131|NCT01456910|"~     Resistance exercise (RE) has been proposed as a possible strategy for prevention and~     rehabilitation of diseases. The increase in both muscle strength and the ability to perform~     tasks of day-to-day work environment and are well-characterized benefits of this type of~     training. The literature has been investigating the effectiveness of the RE for humans, yet~     few studies have been conducted with intellectual disabilities (ID). It is known that a~     sedentary lifestyle contributes to the development of cardiovascular disease, type 2~     diabetes, hypertension, arthritis, and stress, depression, difficulty in socializing, stigma~     and discrimination. In particular, the ID is less active and is more likely to develop~     secondary diseases.~   "
161132|NCT01456897|"~     To investigate the safety and efficacy of long-term administration of OPC-34712 in patients~     with schizophrenia.~   "
161133|NCT01456884|"~     The purpose of this within-subjects randomized controlled trial is to determine whether two~     music therapy interventions are efficacious in reducing pain symptoms, in order to improve~     the quality of care for children in pediatric hospice. The investigators hypothesize that~     both music therapy interventions, live guitar and vocal intervention and vibroacoustic~     intervention, will reduce behavioural pain scores and that behavioural pain scores will~     correlate with physiological outcome measures.~   "
161134|NCT01456871|"~     The purpose of the study is to gain a better understanding of mechanoreceptors in the PIP~     joint ligamento-muscular reflexes and their role is.~   "
161135|NCT01456858|"~     A Phase III malaria prevention trial was conducted in two camps of Liberian refugees in~     Sierra Leone using Insecticide Treated Polyethylene Sheeting (ITPS) or untreated polyethylene~     sheeting (UPS) randomly deployed to defined sectors of each camp. The ITPS was impregnated~     with pyrethroid insecticide during manufacture. In Largo camp the ITPS or UPS was attached to~     inner walls and ceilings of shelters, while in Tobanda the ITPS or UPS was used to line the~     ceiling and roof only. Cohorts of children up to 3 years of age were cleared of malaria~     parasites and monitored for up to 8 months post construction for possible malaria~     re-infection. Installation teams and refugee groups were blinded as to whether the sheeting~     was insecticide treated or not.~   "
161136|NCT01456845|"~     The purpose of the study is to estimate plasma drug levels ( free and total drug levels ) of~     rifampicin and other antituberculosis drugs and compare these drug levels in patients who~     develop drug induced hepatotoxicity versus those who do not .The study hypothesis is that the~     ATT drug induced hepatotoxicity is related to free drug levels of rifampicin and other~     antituberculosis drugs .~   "
161137|NCT01456832|"~     This study is designed to determine the causes of low sodium (salt) in the body fluids~     outside the cells for patients who have received a kidney transplant at the Mayo Clinic of~     Florida. The investigators will look at data collected on previous transplant patients at the~     Mayo Clinic to determine if the low sodium levels could be related to factors occurring in~     the course of surgery. The investigators hypothesize that the intravenous fluid used in the~     surgery, which is about half the concentration of normal saline, could contribute to the low~     sodium levels.~   "
161138|NCT01456819|"~     This is a randomized and single blinded study aimed to compare the efficacy between~     intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell~     implantation and intramuscular autologous bone marrow mononuclear cells implantation only in~     patients with chronic critical limb ischemia. Patients will be randomized into two groups of~     equal number; patients in one group will be implanted with mononuclear cells and mesenchymal~     stem cells, and the other implanted with mononuclear cells only in the area of affected limb.~   "
161153|NCT01456624|"~     The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and~     Megace 800mg/20ml in healthy male volunteers under fasting and fed condition.~   "
161154|NCT01456611|"~     The objective of this study is to evaluate the clinical equivalence and safety of the Test~     formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to~     the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in~     patients with osteoarthritis of the knee.~      The efficacy of both the Test and Reference formulations will also be compared to the Placebo~     gel to determine Superiority.~   "
161139|NCT01456806|"~     Objective: To evaluate the effect of system interventions (data recording procedures and~     complete coverage of medications and supplies) with or without physician and/or patient~     education, upon the psychological, clinical, metabolic and therapeutic indicators and the~     costs of care of people with type 2 diabetes.~      Design: Randomized 2x2 design; sample size was determined considering the change in~     haemoglobin A1c (primary outcome variable) using a two-sided test at the 5% level of~     significance, and 80% power using a paired t-test. Sample size was increased by 25% to~     account for non-independence and patient drop-out.~      Setting: Primary care level in the city of Corrientes, Argentina with involvement of all~     three Argentinean health subsectors (public health, social security and the private, prepaid~     system).~      Participants: 36 general practitioners and 468 adults (62-71% women, mean age 62 years) with~     type 2 diabetes. Patients of the participating physicians (nine in each group), were randomly~     selected and assigned to one of four groups (117 patients each): control, provider education,~     patient education, and provider/patient education.~      Intervention: Structured group education programmes were delivered to provider and/or people~     with type 2 diabetes by trained professionals; identical system interventions were applied to~     all four groups.~      Main outcome measures: Body mass index, blood pressure, fasting glucose, haemoglobin A1c~     levels, lipid profile, drug consumption, resource use, and patient well being (WHO-5~     questionnaire and Lowe score), at baseline and up to 42 months at every 6 months intervals.~   "
161140|NCT01456793|"~     The purpose of this study is to evaluate the effectiveness of the Teen Options to Prevent~     Pregnancy (T.O.P.P.) program in increasing contraceptive use and reducing repeat pregnancies~     among pregnant and parenting adolescents in central Ohio.~   "
161141|NCT01456780|"~     This is a Phase IV, single site, randomized, double masked, parallel control clinical trial~     of 60 subjects to investigate the variance of efficacy between Lotemax® and Zylet® for~     treatment of ocular surface inflammation due to meibomian gland dysfunction (MGD). Efficacy~     will be measured by in-vivo confocal microscopy, corneal fluorescein staining, grading of~     meibomian gland dysfunction and validated ocular symptom assessment questionnaire.~   "
161142|NCT01456767|"~     The design of this study conforms to a randomized double-blind placebo-controlled cross-over~     design.~      The objective of the study is to assess the effect of three probiotics (Lactobacillus~     plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) on~     intestinal epithelial permeability and the immune system, in at least 8 healthy subject.~      The effect of the three different probiotics and a placebo will be assessed on every subject~     in random sequence.~      Prior to the start of a 7-days supplementation period (one of the three probiotic supplements~     or placebo), blood samples will be obtained and small intestinal permeability will be~     assessed by measuring the urinary extraction ratios of ingested water-soluble, non-degradable~     test probes, with and without indomethacin challenge (to compromise the gut). After each~     supplementation period the gut will be stressed again by the indomethacin protocol, followed~     by measurement of small intestinal permeability, whereupon blood samples will be taken and~     duodenal tissue samples will be obtained by standard gastroduodenoscopy. Each supplementation~     period will start 1 month after finishing the pervious test episode, in randomized sequence.~      The primary objective of this study is to assess the effects of Lactobacillus plantarum~     WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 on intestinal~     epithelial permeability. Secondary objectives are to assess the effects on immune modulation,~     gene expression of peripheral blood mononuclear cells, small intestine epithelial gene~     regulation and tight junction proteins modulation, infiltration of immune cells in intestinal~     mucosa and immune markers in blood plasma.~      The investigators hypothesize that Lactobacillus plantarum WCFS1, Lactobacillus plantarum~     CIP104448, and Lactobacillus plantarum CIP104450 will, each separately, significantly affect~     the innate immune system and intestinal permeability in humans.~   "
161143|NCT01456754|"~     The purpose of this study is to determine the effect of feeding frequency on glucose and~     insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.~   "
161144|NCT01456741|"~     Endobronchial lung cancer tend to manifest in three different patterns. It can present as a~     bulky, exophytic mass lesion, submucosal infiltration or extrinsic compression from~     peribronchial disease. Bronchoscopy with differents techniques as forceps biopsy, bronchial~     brushing and bronchial washing is recognized as the gold standard to diagnose central airways~     lung neoplasms. Some authors suggested that the addition of endobronchial needle aspiration~     (EBNA) to these conventional diagnostic methods may increase the sensitivity of bronchoscopy~     in submucosal and peribronchial disease but few prospective trials have been performed and~     this procedure is still underutilized in many centers. Rapid on-site evaluation (ROSE) showed~     to improve yield of transbronchial needle aspiration (TBNA) of mediastinal nodes and~     pulmonary peripheral lesions, reducing the number of inadequate specimens and costs. However,~     its utility during endobronchial needle aspiration has not been substantiated.~      This prospective study has two primary objectives: to compare the sensitivity of ROSE-EBNA~     with that of the conventional technique and to investigate the diagnostic yield of~     endobronchial needle aspiration and its contribution to CDM in the evaluation of patients~     with endobronchial lesions.~   "
161145|NCT01456728|"~     The purpose of the study is to confirm that simultaneous use of L. reuteri ProGastria and~     omeprazole for 28 days can eradicate H. pylori in humans in the absence of antibiotics.~   "
161146|NCT01456715|"~     Two human papillomavirus vaccines are now commercially available.~      No clinical data exist regarding:~        -  The immunogenicity and safety of Gardasil and Twinrix when co-administered.~        -  The immunogenicity and safety of Cervarix when administered to subjects previously~          vaccinated with Gardasil.~      The main objective of the first phase of this clinical trial was:~      • To assess and compare the immunogenicity of Gardasil and Twinrix Junior when~     co-administered or administered at one month interval according to a 0, 6 month schedule to~     9-10 year-old girls.~      The main objective of the seconde phase of this clinical trial is:~      • To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when~     given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.~      Study Design & Duration:~      Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study~     with two treatment groups.~      Duration of the study:~      Participants will be followed for the duration of 10 years post-primary vaccination.~      Number of Centres:~      One Center.~   "
161147|NCT01456702|"~     It is difficulte to evaluate risk patients and to find the ideal intraoperative volume~     management. It seems to be that ill patients benefit of a goal directed volume management.~     The aim of this study is to implement the guidelines on perioperative cardiovascular~     evaluation and care for non-cardiac sugery and to improve perioperative a goal-directed~     protocoll for volume management.~   "
161148|NCT01456689|"~     The primary purpose of this dose escalation study is to estimate the maximum tolerated dose~     (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when~     administered orally once daily to adult patients with Multiple Myeloma (MM).~   "
161185|NCT01456208|"~     Thank you for your interest in the investigators Genetics and Blood Pressure Research Study.~     The National Institutes of Health are sponsoring us to investigate why patients develop high~     blood pressure, atherosclerosis (hardening of the arteries), and heart disease. There are two~     parts of the investigators research program. The first part is a screening visit. At this~     visit you will be given a brief physical exam and will be asked questions concerning your~     medical history. During the same visit you will have your blood drawn for routine screening~     and to prepare DNA for genetic testing. You will also be asked to collect a urine sample for~     routine screening.~      If the doctor finds that you are a healthy candidate you will be invited to participate in~     the second part of the study. During Phase II, the investigators will perform physiological~     tests after you are placed on a low salt diet and again after you are placed on a high salt~     diet. If you are on blood pressure medication, it may be necessary to discontinue taking your~     present medication for up to three months before beginning the study. Patients discontinuing~     their current blood pressure medication may be placed on a different blood pressure~     medication during this washout period if necessary to maintain blood pressure at pre-study~     levels. The investigators will take you off all medications at about two weeks prior to your~     scheduled in-patient study (overnight visits).~      Once your blood pressure medications are discontinued, you will be closely monitored to make~     sure you do not encounter any difficulty. If you do not own a home blood pressure monitor,~     the investigators will provide one for you to use during the study so that you can keep a~     daily record of your blood pressure readings. The investigators will ask you to call us every~     three days to report your blood pressure readings. Less than 20% of patients have any~     significant increase in their blood pressure during this short time off of therapy. After you~     have stopped taking your medication, dieticians at the hospital will make you low salt meals~     to eat at home for seven days. On the seventh day of the low salt diet, you will be asked to~     begin a 24-hour urine collection that you will bring with you when you are admitted to the~     hospital that evening. That morning, you will be required to come to the Clinical Research~     Center for a one-hour test to check if your body is in the correct salt balance. You will~     return that evening to the inpatient Clinical Research Center where you will be admitted for~     your study that will occur the next morning. On the morning of your low salt study, you will~     have naturally occurring hormones administered and blood samples drawn from an intravenous~     needle. The investigators will also take ultrasound pictures of your heart to see how salt~     and hormones affect the way the heart functions. These tests will last approximately five~     hours and you will be discharged around 2:00 PM. For the next five days, you will be placed~     on a high salt diet. During these five days, you will eat all your own food, but the~     investigators will give you some supplements to eat with your meals. After five days on your~     high salt diet, on the morning of your second admission to the hospital, you will be asked to~     begin a final 24-hour urine collection. That morning, you will again be required to come to~     the Clinical Research Center for a one-hour test to check if your body is in the correct salt~     balance. You will return that evening to the inpatient Clinical Research Center where you~     will be admitted for your final study that will occur the next morning. The same study that~     was done for the low salt study will be repeated for the high salt study. You will be~     discharged around 2:00 p.m. This study will determine if you are salt-sensitive. In addition,~     the investigators hope to learn more about the hormones that regulate your blood pressure and~     the genes responsible for regulating those hormones.~      You will be placed back on your initial blood pressure medication (if you are on any) and~     returned to your regular physician for care. The investigators will provide clinically~     relevant information to you and your physician.~   "
161186|NCT01456195|"~     The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam),~     once daily (QD), in participants with type 2 diabetes mellitus (T2DM).~   "
161155|NCT01456598|"~     -  It was confirmed that the laparoscopic surgery decreases the postoperative pain and~          reduces the recovery periods in the various surgical fields such as cholecystectomy and~          colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is~          applicable to malignant tumor according to the development of surgical techniques and~          medical instruments.~        -  In case of early stage of gastric cancer, as the diverse clinical evidences, the~          gastrectomy has been commonly applied, however, the opening surgery is still applied for~          advanced gastric cancer due to lack of clinical evidence.~        -  In Korea, approximately 38% of patients who undergo surgery for gastric cancer are~          diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer~          registration business in 2009). There are various clinical evidences to apply~          laparoscopic surgery to the patients, however, most of them are retrospective or cohort~          study results.~        -  For the clinical application of surgical treatment regarding locally advanced gastric~          cancer using laparoscopic surgical technique, it requires the confirmation of definite~          execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of~          surgery and oncological usefulness should be verified.~        -  In order for this, it is only possible to confirm through the comparison of short-term~          surgical results (complications, mortalities, operative time and duration of~          hospitalization etc) and long-term results (survival rates and recurrence rates etc)~          between laparoscopic surgery and opening surgery based on the multicenter large-sized~          randomized prospective study with current standard treatment.~   "
161156|NCT01456585|"~     This is a pilot study to evaluate the role of the addition of CP870, 893 to the neoadjuvant~     and adjuvant setting for patients with resectable pancreatic cancer. Patients will receive~     standard surgery followed by chemoradiation for their disease, but one dose of gem/cp 870,893~     will be pre-op and 3 doses post-op.~   "
161157|NCT01456572|"~     The purpose of this study is to determine the reciprocal control between gastric functions~     and intestinal parameters in the development of satiation in obese people.~   "
161158|NCT01456559|"~     The purpose with the planned study is to study Pleth Variability Index (PVI) as a non~     invasive indicator for mild hypovolemia during spontaneous breathing in healthy subjects.~     Lower body negative pressure (LBNP), a well established technique is used to create defined~     levels of hypovolemia.~      Primary hypothesis: By applying a breathing resistance (positive end expiratory pressure~     PEEP) to spontaneous breathing, the respiratory synchronous variation in the pulse oximeter~     signal (PVI) is enhanced and enables PVI to detect and grade the level of mild hypovolemia.~      Secondary hypothesis: 1) When tidal volume is increased, the respiratory synchronous~     variation in the pulse oximeter signal (PVI) will also increase. 2) The earlobe is superior~     to the finger in detecting PVI 3) Hemoglobin (Hb), detected non invasively by pulse oximetry,~     is not affected by hypovolemia created by LBNP~   "
161159|NCT01456546|"~     The aim of this study is to investigate if the genetic variant CYP2C19*17 affects the~     pharmacokinetics of proguanil and clopidogrel.~   "
161160|NCT01456533|"~     Background: Hypo- and hypernatremia are common in hospitalized patients. The differential~     diagnosis of dysnatremia is challenging.~      Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism~     in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger~     precursor peptide along with copeptin, which is a more stable peptide directly mirroring the~     production of ADH.~      Objective: To evaluate the additional value of copeptin to improve a currently used algorithm~     in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia.~      Design: Prospective observational study.~   "
161161|NCT01456520|"~     This study aims to determine whether the hydrocodone and acetaminophen exposures following~     oral dosing of Vycavert are comparable to those following oral dosing of Norco.~   "
161162|NCT01456507|"~     The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets~     on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an~     extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered~     naltrexone 4.8 mg.~   "
161163|NCT01456494|"~     The purpose of this study is to evaluate the feasibility of enrolling and randomizing~     patients into one of two educational interventions to teach appropriate respiratory inhaler~     technique and to collect preliminary estimates of the comparative effectiveness of two types~     of education.~      Teach-to-Goal (TTG) education employs instruction followed by patient teach-back, then~     repeated cycles of learning and assessment until a skill, i.e. respiratory inhaler technique,~     is mastered. By contrast, Brief Intervention (BI) education only consists of providing the~     patient with verbal and written instruction on the skill, i.e., respiratory inhaler~     technique.~      The investigators hypothesize that hospital-based TTG compared to BI increases a patient's~     ability to learn respiratory inhaler technique. The investigators will test this hypothesis~     separately for the MDI and Diskus® devices.~   "
161164|NCT01456481|"~     About 20% of adults faint recurrently. These patients are often highly symptomatic, have~     problems with employment and driving and have reduced quality of life. There are no therapies~     that have withstood the test of adequately designed and conducted randomized clinical trials.~     Midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist that increases~     venous return to the heart and raises blood pressure. There is considerable lower level~     evidence that it might prevent vasovagal syncope.~      The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in~     patients with moderate to severe vasovagal syncope.~   "
161165|NCT01456468|"~     The purpose of this research study is to determine whether the combination of UDCA and ATRA~     taken for 3 months will improve laboratory tests of liver and bile duct inflammation in~     patients with Primary Sclerosing Cholangitis (PSC). Our hypothesis is that a combination of~     these medications will improve the liver inflammatory tests in these patients, specifically a~     reduction in alkaline phosphatase (AP) by at least 30%.~   "
161166|NCT01456455|"~     Descriptive registry to investigate frequency of HER-2 positive gastric cancer involving CNS.~      Exploration of additional prognostic factors for brain involvement from gastric cancer.~   "
161205|NCT01455948|"~     The economic, patient related outcome, and effectiveness of balloon sinuplasty in the~     treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare~     environment is not known at this time. This study will evaluate the impact of balloon~     sinuplasty and traditional FESS treatment on CRS patients.~   "
161167|NCT01456442|"~     The aim of this monocentric, prospective, non randomised study with 25 healthy volunteers is~     to assess anorectal function ( i.e rectal compliance and sensory thresholds) in health with a~     short protocol barostat versus conventional procedures (i.e. standard barostat protocol and~     high resolution anorectal manometry). Anorectal dysfunction is a key mechanism in the~     development of fecal incontinence and symptoms of obstructive defecation.~      In this study volunteers will be examined - after explanation, physical examination and~     verification of in- and exclusion criteria - by anorectal barostat with short and standard~     protocol as well as by proctoscopy and endoanal ultrasound.~   "
161168|NCT01456429|"~     This is a prospective non-randomized multicenter clinical trial performing endobronchial and~     esophageal ultrasound for mediastinal lymph node staging of operable and resectable~     cT1-T2-selectedT3 cN1 cM0 NSCLC.~   "
161169|NCT01456416|"~     The incidence of autoimmune conditions is at least 2-3 times higher in Multiple Sclerosis~     population than in general population. These MS patients category response unfavorably to the~     Interferon. The investigators suggest that autoimmune co morbidity can serve as a biological~     marker predicting good response to GA.~   "
161170|NCT01456403|"~     Patients scheduled for carotid endarterectomy undergo preoperative imaging to assess~     vulnerable plaque. The imaging modalities include (in various combinations at different study~     sites) 3-dimensional ultrasound, PET/CT imaging with fluorodeoxyglucose, MRI (3T)with~     gadolinium, and contrast ultrasound for assessment of neovascularity of plaques. At surgery~     the carotid endarterectomy is carried out with en bloc removal of the specimen, which is~     scanned and stained and assembled into 3D histology.~   "
161171|NCT01456390|"~     Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular~     hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent~     stents in combination with one iStent supra stent and a postoperative prostaglandin.~   "
161172|NCT01456377|"~     The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids~     administered orally in narrow lumbar canal syndrome.~   "
161173|NCT01456364|"~     Clopidogrel low response is associated with a significantly higher risk for ischemic~     complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more~     potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic~     events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in~     terms of their antiplatelet efficacy exists. The aim of this study is to assess the~     antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed~     clopidogrel low responders undergoing percutaneous coronary intervention.~   "
161174|NCT01456351|"~     The study addresses the question if a therapy with bendamustine plus rituximab is comparable~     (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to~     event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.~   "
161175|NCT01456338|"~     The purpose of this phase of the study is to further assess the efficacy of cognitive~     behavioral therapy (CBT) for posttraumatic stress disorder (PTSD), as delivered by routine~     addiction counselors, and to compare CBT for PTSD with individual addiction counseling (IAC)~     on our primary outcomes.~   "
161176|NCT01456325|"~     This randomized, multicenter, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in~     participants with incurable non-small cell lung cancer identified to be Met~     diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb)~     or placebo in combination with erlotinib. Anticipated time on study treatment is until~     disease progression or unacceptable toxicity occurs.~   "
161177|NCT01456312|"~     Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion~     rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week~     follow up)~      Secondary objective :~        -  The changes of HBsAg titer~             -  The rate of combined HBeAg seroconversion and HBV DNA < 300 copies/mL ⅲ. The rate~               of serum HBV DNA < 300 copies/mL~                  -  The rate of ALT normalization ⅴ. The rate of HBsAg loss ⅵ. The rate of serum~                    HBV DNA < 10,000 copies/mL~   "
161178|NCT01456299|"~     The purpose of this study was to determine the most suitable effect-site concentration of~     remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.~   "
161179|NCT01456286|"~     The purpose of this study is to determine whether sapropterin (an oral analogue of~     tetrahydrobiopterin) could have a role in the treatment of portal hypertension secondary to~     liver cirrhosis. Sapropterin or placebo will be given for two weeks in patients with liver~     cirrhosis and clinically significant portal hypertension. Systemic and hepatic hemodynamics~     studies will be performed at baseline and after the intervention to assess the effect of~     sapropterin.~   "
161180|NCT01456273|"~     This study aims to evaluate, in patients with functional dyspepsia, a model example of~     medical care based upon the biopsychosocial model (called: the therapeutic encounter)~     compared with standard medical care based upon the biomedical model (called: medical~     consultation).~   "
161181|NCT01456260|"~     The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during~     long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a~     history of gastric or duodenal ulcer who require long-term therapy of NSAID.~   "
161182|NCT01456247|"~     The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during~     long-term concomitant low-dose aspirin therapy in patients with a history of gastric or~     duodenal ulcer who require long-term therapy of low-dose aspirin.~   "
161183|NCT01456234|"~     The main purpose of this study is to see if patients with the flu would receive oseltamivir~     treatment more quickly if it were prescribed by a pharmacist as compared to a physician, and~     to see if there is any difference in the effect of treatment on flu symptoms and overall~     health. Another reason for doing the study is to see how accurately pharmacists can diagnose~     the flu as compared to physicians. Viruses that are exposed to antiviral medications (like~     oseltamivir) sometimes develop a resistance to the medication. This means that the medication~     is no longer as effective in treating the symptoms caused by the virus. The development of~     viral resistance to oseltamivir will also be followed in this study.~   "
161184|NCT01456221|"~     The purpose of this study is to evaluate if a supplement containing omega-3 long chain~     polyunsaturated fatty acids for three months reduce obesity and insulin resistance to obese~     adolescents if administered together with a hypocaloric diet.~   "
161187|NCT01456182|"~     This trial will assess the tolerability and safety of AFX-2 over a range of five dose levels~     in adults with low-, intermediate- or high-risk Chronic Lymphocytic Leukemia (CLL). The trial~     will also determine the impact of dose on quality of life indices and on biological and~     immune responses, and will assess if there is a maximum tolerated dose and/or dose-limiting~     toxicity in this study population.~   "
161188|NCT01456169|"~     The purpose of this study is to evaluate the efficacy and safety of the fixed dose~     combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily,~     in participants with grades 2 or 3 essential hypertension who do not reach target blood~     pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.~   "
161189|NCT01456156|"~     Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some~     patients can not receive radical resection. Such patients have high risk of recurrence. Tumor~     resection and postoperative radiation is an option for such patients to achieve radical~     treatment and radiation may reduce local recurrence.~   "
161190|NCT01456143|"~     This study examines if certain imaging techniques and devices can aid the surgeon in~     detecting cancer during the surgical procedure.~   "
161191|NCT01456130|"~     The purpose of this study is to evaluate the safety and efficacy of alogliptin as an add-on~     to a rapid-acting insulin secretagogue (medicine that stimulates insulin release) in type 2~     diabetic patients with inadequate blood glucose control despite treatment with a rapid-acting~     insulin secretagogue as well as diet and exercise therapies.~   "
161192|NCT01456117|"~     The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on brain~     hemodynamics in healthy elderly participants.~   "
161193|NCT01456104|"~     This study is being done to see if the investigators can help the immune system to work~     against melanoma.~      A dendritic cell is another type of white blood cell. It has most, if not all, of the~     proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not~     normally have the cancer proteins on their surface. The challenge then is to combine the~     antigens with dendritic cells to make a vaccine. The investigators think that the body's T~     cells might then react against the tumor and help destroy it.~      This study will see if altered dendritic cells will make T cells work against tumor cells.~     The dendritic cells will be made in a lab and will carry the antigens. These cells then will~     be injected under the skin.~      In this study, the investigators are trying to help the body make a stronger immune response~     against the cancer. The patient will get the same kind of dendritic cell vaccine used in the~     earlier study, but with one major difference. The dendritic cells will contain messenger-RNA~     (mRNA). Cells use mRNA to make proteins. The mRNA will be put into dendritic cells by a~     laboratory method called electroporation. The mRNA is never given to the patient directly.~     This mRNA will help the dendritic cell make a tumor antigen like what the cancer expresses.~     The dendritic cell can then put this tumor antigen on its surface so that the body could make~     a stronger immune response against the tumor.~   "
161194|NCT01456091|"~     The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in~     increasing the use of long-term contraceptives, in improving adherence to contraceptives and~     in preventing rapid repeat pregnancies among parenting adolescents.~   "
161195|NCT01456078|"~     By improved kidney dosimetry including biological effective dose and taking into account~     potential risk factors (especially for kidney toxicity), it might be possible to give an~     optimal and personalized treatment with 177Lu-DOTA-TATE to the patient with metastatic~     neuroendocrine tumor.~   "
161196|NCT01456065|"~     The purpose of this study is to investigate the safety of the active immune therapy based on~     the reiterated injection of fully mature, TERT (Telomerase Reverse Transcriptase)-mRNA and~     Survivin-peptide double loaded DCs (Dendritic Cells) [Procure®] in patients with advanced~     ovarian cancer, enrolled into the study within twelve weeks after completing primary therapy.~   "
161197|NCT01456052|"~     This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and~     preliminary effectiveness of two blinded dose levels of LX1606 in subjects with acute, mild~     to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.~   "
161198|NCT01456039|"~     The purpose of the study was to assess efficacy, tolerability, safety and pharmacokinetics of~     Romidepsin in subjects with progressive or relapsed peripheral T-cell lymphoma~   "
161199|NCT01456026|"~     Recent evidence supports detrimental effects of advanced glycation endproducts (AGE) on~     vascular function (VF). Though, the effect of AGE-modified proteins alone on vascular~     function remained unknown. Therefore, the aim of our study is to investigate the effects of~     heat-treated, glycated beta-lactoglobulins (BLG) on vascular function in subjects with type 2~     diabetes mellitus (T2DM) and to compare it to non-glycated, heat-treated BLG.~   "
161200|NCT01456013|"~     Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems~     undergo procedures that use iodinated contrast media, such as cardiac catheterizations.~     RenalGuard Therapy was developed to enable the patient to clear the contrast out of their~     kidney before it can do significant damage. This study aims to enroll patients with increased~     risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will~     be randomized to either RenalGuard therapy or standard therapy.~   "
161201|NCT01456000|"~     The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus~     Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial~     fibrillation by creating electrical isolation of the pulmonary veins.~   "
161202|NCT01455987|"~     Osteochondritis dissecans is a relatively common...~   "
161203|NCT01455974|"~     Unfavorably high sodium intakes remain prevalent around the world. A negative sodium gradient~     in hemodialysis treatment results in absolute sodium removal via diffusive transport of~     sodium from the blood to the dialysate, and it may be a potentially useful tool to improve~     sodium loading due to excess dietary sodium intake.~      The purpose of this study is to determine whether a in small negative sodium gradient could~     improve blood pressure level, arterial stiffness and left ventricular hypertrophy in~     hypertensive hemodialysis patients, who had been achieving and maintaining their dry weight~     assessed by bioimpedance spectroscopy.~   "
161204|NCT01455961|"~     The aim of this study is to describe the treatment pattern and patient characteristics in~     real life setting in patients with Bipolar disorder treated with Seroquel XR and/or Seroquel~     IR in Sweden.~   "
161214|NCT01455831|"~     The human body has a natural stress response to surgery, including the formation of blood~     clots. This response to surgery has been shown to increase metastases (the spread of cancer~     cells to other organs in the body). These metastases cannot be seen at the time of surgery~     but when they grow into new tumors, the cancer has recurred (come back). A blood thinner~     called low molecular weight heparin (LMWH) can suppress the development of metastases after~     surgery in animal experiments. The investigators want to see if giving patients with~     colorectal cancer the blood thinner, LMWH, around the time of surgery can decrease the chance~     of their cancer spreading to other organs (metastases) and coming back (recurrence).~      The investigators need 1075 patients to answer our scientific question. Patients who give~     informed consent will be randomly put into one of two groups, the experimental group and the~     control group. The patients in the control group will be treated with LMWH starting a few~     hours after surgery and every day until they leave the hospital. This is how most patients~     are treated after colon cancer surgery (standard care). The patients in the experimental~     group will be treated with LMWH for a longer period of time, starting on the day they agree~     to have surgery and continuing for two months after surgery. All the patients will be~     followed for at least three years after surgery to find out if their cancer has recurred~     (come back). If LMWH treatment around the time of surgery reduces the chance of recurrence in~     patients with colorectal cancer, it would improve the health and quality of life for these~     patients.~   "
161215|NCT01455818|"~     Blood clots in lung arteries (pulmonary embolism) are usually detected using a radiological~     test called computed tomography (CT scan). As technology advances, the CT scans are able to~     detect smaller and smaller blood clots. Over time, the frequency of blood clots in the~     pulmonary arteries has increased significantly (CT scan are now detecting very small blood~     clots that the investigators could not see before). As a result, more and more people are on~     blood thinners to treat these small blood clots but their true clinical significance is~     unknown.~      The management of blood thinners is costly and also utilizes scarce healthcare resources.~     These blood thinners need to be monitored with frequent blood work. Furthermore, every year,~     approximately 3 percent of patients on blood thinners will have a major bleeding event~     requiring medical attention.~      The investigators don't think that treating these small blood clots in the pulmonary arteries~     detected on CT scan is worth the risk of bleeding from the blood thinners.~      The main goal of this study is to find out if it is safe to not treat very small blood clots~     in the pulmonary arteries.~      The investigators plan to follow 300 patients with small blood clots in their lungs for 90~     days. These patients will not be treated with blood thinners but will be followed closely~     with other non-invasive tests to avoid progression or recurrence of blood clots.~   "
161216|NCT01455805|"~     Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the~     lower part of the back. This causes discomfort in the legs when standing or walking because~     of pressure on the spinal nerves.There are several treatment options for LSS including~     physiotherapy, lumbar surgical decompression procedures such as laminectomy, Foraminotomy,~     Discectomy and more recently devices for interspinous distraction such as the XSTOP® and from~     May 2011 Minuteman™.~      Surgical decompression for LSS involves the removal of excess bone, ligament, and soft-tissue~     allowing more room for the nerves. The operation is usually preformed under general~     anaesthetic and with an average stay in hospital for 2-3 nights. Whereas the Minuteman™~     implant is preformed as a day case under local or general anaesthetic and involves implanting~     the device into the space between two back bones to relieve pressure on the nerves and,~     therefore, pain in the legs.~      This is a multi centred (four sites) randomised controlled trial with a total sample of 50~     participants after obtaining their informed consent. Participants will attend the pain clinic~     at the Hospitals for a baseline visit where they will be randomised with a ratio of 1:1 to~     receive either the Minuteman™ Interspinous interlaminar fusion Implant or standard surgical~     decompression for the treatment of lumbar spinal stenosis (LSS). Following randomisation~     arrangements will be made for the participant to receive the randomised treatment. If~     allocated to Minuteman™ Implant, the treatment will be conducted by the Pain Specialist~     identified at the site. If allocated to surgical decompression, the treatment will be~     conducted by the neuro/spinal-surgeon identified at the site. Participates will be followed~     up regularly for 60 months post implant to assess clinical efficacy, safety, participants~     function and quality of life of each treatment.~   "
161217|NCT01455792|"~     Background: Prostate biopsies are usually performed due to accidentally discovered elevated~     prostate specific antigen (PSA) and/or abnormal digital rectal examination. Transrectal~     ultrasound (TRUS) guided biopsy is standard procedure, but possibility for precise~     documentation concerning the localization of the biopsies are lacking. Therefore, the same~     locations might be subject to multiple negative biopsies. There is a growing confidence that~     magnetic resonance imaging (MRI) of the prostate gland can identify significant, high-grade~     tumours, and studies have shown value in performing MRI before biopsies. Because image~     documentation is lacking, it is not possible to know which region actually being biopsied~     with conventional TRUS biopsy. MRI and 3D ultrasound soft image fusion guided biopsy, is a~     new promising method that will ascertain all regions of the prostate gland to be biopsied,~     and it is possible to perform accurate targeted biopsies when combined with MRI.~      Aims of the study~      Compare the biopsy results in the two groups:~        1. To evaluate the overall rate of positive biopsies.~        2. To evaluate the rate of re-biopsies.~        3. To evaluate the detection rate of Gleason grade 4 and 5 tumours.~        4. To evaluate the rate of positive targeted biopsies.~        5. To evaluate the rate of positive random biopsies~        6. To compare targeted and random biopsies between groups.~        7. To compare patient tolerance, time consumption and cost of the two methods.~        8. To evaluate the diagnostic accuracy of performing cytological imprints of targeted~          biopsies.~      Material and methods: A prospective randomized study including 300 consecutive patients~     referred to the initial biopsy. The patients are randomized to conventional TRUS biopsies and~     image fusion guided biopsy.~      All patients undergo a minimum 12-core re-biopsy procedure. In addition a targeted biopsy~     will be obtained in case of positive MRI of ultrasound.~   "
161218|NCT01455779|"~     The purpose of this study is to demonstrate the treatment efficacy of the Lyrette® System in~     women most likely to be treated in an office setting for the condition of stress urinary~     incontinence, secondary to urethral hypermobility.~   "
161219|NCT01455766|"~     The hypothesis of this observational single-center clinical study was to explore the~     volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic~     intervention. The investigators monitored the changes in the volumes of blood in the central~     vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e.~     extravascular lung water).~   "
161220|NCT01455753|"~     Using desk location information and employees' building entry/exit swipe card data from a~     company that offered a free 2-day worksite influenza vaccination clinic, we separately~     identify the vaccination effects of base proximity—the inverse of walking distance between~     one's desk and the clinic—and functional proximity—the likelihood of passing near the clinic~     during the course of a normal work day (ie, days when the clinic is not open).~   "
161221|NCT01455740|"~     We used a randomized trial design combined with a comparison to a non-randomized control~     group to study patients on appropriate antiretroviral therapy (ART) having virologic failure~     within a publicly-funded HIV clinic serving Atlanta, GA.~   "
161298|NCT01454739|"~     The primary objective of the study is to evaluate the long-term safety of recombinant human~     Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary~     objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and~     treatment of bleeding episodes in participants with hemophilia A.~   "
161222|NCT01455727|"~     This trial will try to perform pharmaceutical care on ambulatory elderly diabetes patients.~     To provide appropriate diabetes education administration, identify and resolve drug-related~     problems, assess the appropriateness of their medications, establish the mechanism of~     medication consultations. Each patient will be assessed by the MMSE(Mini-Mental State~     Examination) and GDS(Geriatric Depression Scale). The effectiveness of pharmacist's~     intervention will be assessed by lab data and some questionnaires.~   "
161223|NCT01455714|"~     Finding early predictors of myocardial in patients with hypertension~        1. Scientific objective The study objective is to clarify the grounds of heart exertional~          dyspnoea stenocardial pain in patients with well-controlled stage I or II hypertension~          according to ESH (European Society of Hypertension), without changes in epicardial~          coronary arteries in coronary angiography and normal resting echocardiography result,~          and to assess of potential early markers of heart hypertrophy and failure in patients~          with hypertension.~           Characteristics of the final result The study is to allow for identification of patients~          with hypertension, in whom an early introduction of pharmacological treatment of heart~          failure should be considered. Evaluation in the detection of asymptomatic myocardial~          dysfunction will include potential heart failure markers such as: cardiotrophin 1,~          cystatin C, serum syndecan-4, collagen III N-terminal propetide [PIIINP], MMP-2, MMP-7,~          MMP-8, MMP-9 and NT-proBNP, modern echocardiography methods and magnetic resonance~          imaging in order to increase the effectiveness of prevention, diagnosis and treatment~          optimalization.~        2. Project significance Prognosis in heart failure is very serious. It is similar or worse~          than in advanced cancer. These data indicate an extreme importance of the optimal early~          causal treatment of hypertension and symptomatic treatment of heart failure early stage~          in order to prevent the development advanced form of the disease, which has bad~          prognosis. In clinical practice, patients with well-controlled hypertension often report~          exercise limitation, exertional dyspnea and/or stenocardial pain which is not reflected~          in a standard resting echocardiography (normal result), without coronary artery disease~          data in electrocardiographic stress test and without change in epicardial coronary~          vessels in coronary angiography. The study is designed to establish the panel of~          diagnostic tests in patients with hypertension and exertional dyspnoea only, which will~          allow for early detection of abnormalities (before symptoms occur) and the start of the~          optimal treatment for these patients. Unfortunately, still too small percentage of~          patients receives full pharmacotherapy, hence the authors of the latest guidelines of~          procedure in heart failure and hypertension put great emphasis on this aspect. Optimal~          management may prevent the progression of these patients in stage C heart failure, and~          thus bring tangible benefits not only the patients themselves but also, by reducing the~          number of costly hospitalizations, significantly reduce health care costs. The number of~          hospitalizations for heart failure in Poland is estimated at 100 000 per year, and~          hospitalization costs exceed 70% of the total costs associated with the treatment of~          heart failure. The issue of exertional dyspnoea and overt heart failure in patients with~          hypertension and normal results of resting echocardiography is a new problem, both in~          Poland and in the world.~      So far, there are no treatment recommendations for this group of patients. Material and study~     plan 120 persons (age 40-60 years old) will be included in the study, patients with stage I~     or II primary hypertension according to the European Society of Hypertension: Group A- 40~     patients without symptoms of heart failure Group B- 40 patients with exertional dyspnoea~     Group C - 40 patients with overt heart failure~      In group B (patients with exertional dyspnea/stenocardia) we will include only patients who~     have undergone contrast coronary angiography without any identified changes in the epicardial~     coronary arteries, which will facilitate answering the presented purpose of research.~     Patients in groups A and B with normal resting echocardiography and treated with a maximum of~     2 antihypertensive drugs (an ACE inhibitor or a sartan as therapy base), according to the~     following regimen:~      ACEI/ARB + diuretic ACEI/ARB + calcium channel antagonist Group C - treatment in accordance~     with the standards for heart failure. Each patient will be informed about the objectives of~     the study and give written consent to participate.~      After signing informed consent patients will have performed the following tests:~        -  Interview and documentation analysis,~        -  Physical examination,~        -  Electrocardiogram,~        -  24-hour blood pressure monitoring (ABPM),~        -  24-hour EKG recording,~        -  Echocardiography at rest and during submaxinal exercise on a bicycle ergometer,~        -  Flow-mediated dilatation (FMD),~        -  Cardiac magnetic resonance imaging,~        -  Standard labolatory parameters,~        -  Levels of markers: cystatin C, cardiotrophin-1, metaloproteinases: MMP-2, MMP-7, MMP-8,~          MMP-9, Procollagen III N-Terminal Propeptide (PIIINP), Syndecan 4 (SDC4) and NT-proBNP~          Each patient will be informed about the objectives of the study and give written consent~          to participate.~   "
161224|NCT01455701|"~     This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and~     safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active~     sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on~     study treatment is 12 weeks (Main evaluation period). Participants will have the option to~     continue tocilizumab treatment until participant reaches 2 years of age or up to one year~     from baseline, whichever is longer. An optional extension period will follow the main~     evaluation period.~   "
161225|NCT01455688|"~     The aim of the study is to verify the effect of HAART in critically ill HIV infected~     patients. The current practice is to begin antiviral therapy after ICU discharge, when the~     condition of the patient is more stable. The investigators hypothesis is that the~     investigators can improve outcome of these patients with earlier antiviral therapy in the~     ICU. The investigators just have retrospective studies in this scenario. After admission to~     ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission)~     or conventional therapy (initiation of HAART after ICU discharge). The following data will be~     collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic~     infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be~     followed to determine ICU mortality, hospital mortality and 6-month mortality.~   "
161226|NCT01455675|"~     The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa~     after successfully treated acute or intermittent infection.~   "
161227|NCT01455662|"~     There is a correlation between hospital mortality and changes in markers of tissue perfusion,~     lactate, and venous oxygen saturation and carbon dioxide gradient.~   "
161228|NCT01455649|"~     The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus,~     with its onset after 3 months of treatment with calcineurin inhibitor.~   "
161229|NCT01455636|"~     Low birth weight (LBW) infants are particularly vulnerable to frequent infections and~     consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of~     complementary foods and ultimately micronutrient deficiencies that result in post-natal~     linear growth faltering. The objective of this study is to facilitate improved feeding~     practices through the early reduction of infections using the innovative tools of water-based~     hand sanitizer (beginning at birth) and an improved micronutrient powder (I-MNP) (beginning~     at 6 months of age). A community-based cluster randomized controlled trial will be carried~     out in Bangladesh using a 2x2 factorial design. LBW infants (n=480) will be recruited at~     birth and allocated to either HS or No HS from 0 to 6 months. From 6 to 12 months, half of~     the children in each group will be randomized to receive I-MNP. All groups will receive~     nutrition and hygiene education from birth to 12 months. Recumbent length is the primary~     outcome; morbidity, dietary intake and hemoglobin will be assessed as secondary outcomes. By~     working with BRAC, the largest implementation agency in Bangladesh, there is the opportunity~     to translate the results directly and quickly into child health programs in Bangladesh.~   "
161230|NCT01455623|"~     It is necessary for outcome measures to accurately reflect the state of health of a person in~     order for clinical trials to show benefit. The most commonly used outcome measure for Charcot~     Marie Tooth Disease (CMT) is the CMT Neuropathy Score, which uses cutoffs of points~     designated as mild (0-10 points), moderate (11-20) or severe (21-36). These terms are~     arbitrary. This study is looking to base mild, moderate, and severe on what both people~     affected with CMT and those who provide for people with CMT consider appropriate.~   "
161231|NCT01455610|"~     The purpose of this multicenter and double-blind clinical trial is to prospectively assess~     the sensitivity, specificity, negative predictive value, positive predictive value, and~     accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its~     various post processing techniques, taking operational and pathological records as the gold~     standard.~   "
161232|NCT01455597|"~     This is an open-label extension study evaluating the long-term safety and efficacy of WC3011~     in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.~   "
161233|NCT01455584|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of~     HM781-36B continuously.~   "
161234|NCT01455571|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of~     HM781-36B.~   "
161235|NCT01455558|"~     This study investigates safety and pharmacokinetic comparison of Pacific Pharma's PP-101 SR~     (test formulation) and Otsuka's Pletaal® IR (reference formulation) for single and multiple~     doses and food effects on Pacific Pharma's PP-101 SR in healthy volunteers.~   "
161236|NCT01455545|"~     This survey aims to analyze how adherence to treatment, using Ask-20 questionnaire and~     prescription count, influences level of asthma control in a sample of patients with severe~     and moderate-mild asthma.~   "
161237|NCT01455532|"~     Primary Objective:~        -  To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent~          and in combination with chemotherapeutic regimens in patients with advanced solid tumors~          that are refractory to standard therapy.~      Secondary Objectives:~        -  To assess the antitumor effect of iniparib (per Response Evaluation Criteria in Solid~          Tumors [RECIST]) Version 1.1 in patients with measurable disease.~        -  To characterize iniparib (and its metabolites, if possible) pharmacokinetics.~      Based on data generated by Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
161299|NCT01454726|"~     The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in~     patients with Meniere's disease.~   "
161238|NCT01455519|"~     You are asked to take part in this study because you have chronic, non-radicular low back~     pain. This study is done to investigate the pain relieving effects of the study drug Exalgo~     (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose~     of this research is to look at how the study drug can be used to benefit people who~     experience this type of pain. This is a phase IV study done to study the safety and~     effectiveness of the drug. At this point the drug has been approved by the Food and Drug~     Administration and has been studied in more than 2,000 pain patients in clinical trials,~     including individuals with low back pain. About 36 subjects will take part in this study.~   "
161239|NCT01455506|"~     This is a single institution study of combining decitabine with fludarabine and busulfan in~     the setting of allogeneic stem cell transplantation. A study population of 20 subjects will~     be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center.~     Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation~     according to the eligibility criteria will be consented and enrolled. Subjects will receive~     treatment with decitabine followed by reduced intensity fludarabine and busulfan prior to~     allogeneic stem cell transplantation. Subjects will be followed until 1 year post~     transplantation to assess stability of engraftment, toxicity, progression free survival, and~     disease response~   "
161240|NCT01455493|"~     This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of~     GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety,~     tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.~   "
161241|NCT01455480|"~     The objective of this Trial is to evaluate the performance of RPh201 as a treatment for the~     healing of partial thickness burns. It is further postulated that deep second degree lesions~     will benefit from the RPh201 treatment promoting granulation and epithelialization as well as~     wound closure.~   "
161242|NCT01455467|"~     Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in~     conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of~     one anti-glaucoma medication prior to stent implantation.~   "
161243|NCT01455454|"~     Coagulopathy with transfusion requirements is frequent during cardiac surgery with~     cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole blood~     point of care test used to assess the patient's coagulation status.~      The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence~     of very high heparin concentrations as seen during cardiopulmonary bypass.~   "
161244|NCT01455441|"~     The objective of this study is to investigate the effects of physical training in patients~     with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®)~     in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.~      Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients~     when training is combined with liraglutide (Victoza®) treatment.~   "
161245|NCT01455428|"~     To prove pregabalin is effective in relieving pain compared with placebo in subjects with~     postherpetic neuralgia (PHN).~   "
161246|NCT01455415|"~     This study is to test the effectiveness of pregabalin in treating nerve pain caused by~     diabetes. The suitable subjects will be patients who also use an non-steroid~     anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.~   "
161247|NCT01455402|"~     The primary objective of this observational study is to determine the incidence of medically~     attended (inpatient or outpatient) acute respiratory illnesses or events leading to worsening~     cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary disease~     [AECOPD] or worsening CHF) associated with RSV infections in high-risk adults (ie, those with~     severe COPD and/or advanced CHF) across multiple consecutive RSV seasons.~   "
161248|NCT01455389|"~     The goal of phase 1 of this clinical research study is to find the highest dose of~     DOTAP:Chol-fus1 that can be safely given in combination with Tarceva (erlotinib~     hydrochloride) to patients with NSCLC.~      The goal of phase 2 of this clinical research study is to learn if the combination of~     DOTAP:Chol-fus1 and erlotinib hydrochloride can help to control NSCLC.~      The safety of this drug combination will also be studied in both phases.~      DOTAP:Chol-fus1 is a drug that helps transfer a gene called fus1 into cancer cells.~     Researchers think that cells without this gene may be involved in the development of lung~     cancer tumors. They want to find out if replacing the gene in these cells may keep the tissue~     from forming cancer cells.~      Erlotinib hydrochloride is designed to block a protein on tumor cells that may control tumor~     growth and survival. This may stop tumors from growing.~   "
161249|NCT01455376|"~     Mild traumatic brain injury (TBI) is the most common type of brain injury. Post-mild TBI~     disability could stem from cognitive, physical, psychological and social dysfunction which~     resulted in significant disability and unemployment. Long-term behavioral impairments which~     affected the individual's occupation, lifestyle, and family frequently occurred in~     individuals with mild to moderate brain injuries who physically fully recovered. In-vitro and~     in-vivo studies showed a better recovery of cognitive function after administration of~     exogenous lactate in traumatic brain injury. Therefore, this study is aimed to evaluate the~     effect of exogenous lactate infusion contained in hyperosmolar sodium lactate solution on~     cognitive function assessed by Mini Mental State Examination(MMSE)scale.~   "
161250|NCT01455363|"~     The investigators aim to test the hypothesis and to proof thank to laser speckle contrast~     imaging that post-occlusive reactive hyperemia (PORH) can be induced through a tumor, in this~     case, through a basal cell carcinoma, which will be used as a model of study of tumor~     vasculature.~      This new concept of tumor perfusion artificial increase could be used in the future for~     malignant tumors treatment, in order to increase tumor mean oxygen partial pressure (thus~     decreasing tumor hypoxia, hallmark of malignant tumors) during cancerology therapies, like~     radiotherapy and/or chemotherapy, and increase their efficacy.~      This clinical trial will use skin flap model for trunk and facial basal cell carcinoma (BCC),~     with respect the classical excision margin of BCC surgery (3-4mm): after local anesthesia, a~     little random pattern skin flap will be raised around the BCC, then the cutaneous pedicle~     will be clamped with surgical clamp for 3 minutes and clamp released.~      In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to~     the BCC location.~      During all steps of experimentation, laser speckle imaging will be used to measure~     continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10~     minutes after tumor pedicle clamp or tourniquet release.~   "
161251|NCT01455350|"~     Chronic gynaecological pain is a major medical problem that affects 20-30% of women at~     different moments of their life. This largely neglected issue has a significant impact on the~     sexual and conjugal life of women suffering from it as well as on their psychological health.~     Furthermore, this kind of pain is not well understood, often misdiagnosed or even totally~     ignored. Also, treatment is limited and not extensively studied. This study aims at better~     understanding and treating gynaecological pain. The focus of the study will be provoked~     vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor~     physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva. The~     treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering from~     provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital,~     Royal-Victoria Hospital, CHUM St-Luc).~   "
161252|NCT01455337|"~     Alcoholic hepatitis represents one of the more serious forms of alcoholic liver disease.~     Critically ill patients with alcoholic hepatitis have high morbidity and mortality rate.~     Because of data suggesting that the pathogenic mechanisms in alcoholic hepatitis involve~     cytokine release and the perpetuation of injury by immunologic process, corticosteroid has~     been extensively evaluated in the treatment of alcoholic hepatitis. Although there are~     discrepancies in literature as several randomized trials and meta-analyses have reached~     contradictory results, corticosteroid for a subset of patients with severe alcoholic~     hepatitis, defined as a discriminant function ≥ 32, who also have no concomitant~     gastrointestinal bleeding, active infection, renal failure, and pancreatitis, has been~     recommended. This latter point emphasizes the important of meticulous selection to avoid the~     side effects of corticosteroid. Thus, the beneficial effects seems confined to a highly~     selected minority group in which the inhibitory effect of corticosteroid on liver~     inflammation is not outweighed by side effects such as weakened defense against infection,~     anti-anabolic effects, and possible ulcer-promoting effects causing gastrointestinal~     bleeding, which may be deleterious in these critically ill patients.~      Newer understanding of the role of the role of TNF-α expression and receptor activity in~     alcoholic liver injury has prompted to an examination of TNF inhibition as an alternative to~     corticosteroid for severe alcoholic hepatitis. Pentoxifylline, a nonspecific TNF inhibitor,~     recently has been demonstrated in a randomized trial to improve survival in the therapy of~     severe alcoholic hepatitis. In particular, the survival benefit of pentoxifylline appears to~     be related to a significant reduction in development of hepatorenal syndrome. These results~     are promising, and support the need to further evaluate the potential of this new therapeutic~     avenue.~      There is a need for head to head comparison of corticosteroid and pentoxifylline in severe~     alcoholic hepatitis. At the time the current study was designed (2008), corticosteroid was~     first-line treatment for severe alcoholic hepatitis. This study was designed to demonstrate~     that the effect of pentoxifylline was similar (i.e., not inferior) to that of prednisolone,~     an active form of prednisone. The aim of the present study was thus to compare the effects of~     pentoxifylline and prednisolone on the short-term mortality.~   "
161253|NCT01455324|"~     The purpose of this study is to work with prosthetists to fit the novel conformable socket~     material developed by Infoscitex, to subjects, and determine if it is a viable alternative to~     current prosthetic socket liners. During this task, the research team will travel to the~     prosthetists locations to have them fit the subject with the conformable woven socket and a~     check socket, and provide subjective feedback with regard to comfort and fit for the amputee,~     its ease of use, and breathability. The subject will also wear the woven socket for gait~     analysis and provide his/her feedback as well.~   "
161254|NCT01455311|"~     The goal of this study is to compare a sample of the cyst taken by a standard method (fine~     needle aspiration) to the sample taken by a new method using a device called the EchoBrush to~     see which method is more accurate at diagnosing cancer. We will also look at proteins (also~     called biomarkers) in the samples to see if they predict whether or not the cyst is~     cancerous.~   "
161255|NCT01455298|"~     This cohort study will evaluate the prevalence of the infra clinical liver injuries among a~     group of adult patients presenting with Alpha-1 AT deficiency followed up in a large~     university hospital in Lyon, France.~   "
161256|NCT01455285|"~     Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical nerve~     stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency~     modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Methods: A~     controlled clinical study and prospective developed at the School of Physiotherapy Clinic /~     UFPI. Forty students were randomized into four distinct groups of the modulation frequency~     TENS: group 1 - 100 Hz, 100μs, group 2 - 4 Hz, 100μs, group 3 - placebo (apparatus off),~     group 4 - placebo induced (2 Hz, 40μs). All were initially evaluated by a questionnaire~     developed for the study, the visual analogue scale (VAS) (before, after 20, 30, 40, 50, 60~     minutes) and the McGill Pain Questionnaire (before and after 20 minutes). The total duration~     of TENS application was 20 minutes and all protocols were performed in a single session. The~     analysis of variance (One-way ANOVA) followed by the Tukey procedure was applied to identify~     differences between experimental groups for each variable analyzed. The level of significance~     was p< 0,05.~   "
161257|NCT01455272|"~     Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only,~     option for the treatment of leukemia, particularly for patients with advanced-stage leukemia.~     However, relapse rate was still very high for advanced-stage leukemia.~      It was found in our previous study that infusion of granulocyte colony-stimulating factor~     (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes~     exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or~     less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was~     combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of~     fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI~     combined with the use of short-term immunosuppressant was feasible in patients with advanced~     leukemia to prevent relapse after HLA-mismatched HSCT.~      The study hypothesis:~      Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood~     progenitor cells following hematopoietic stem cell transplantation in patients with~     advanced-stage acute leukemia can~        -  reduce relapse rate~        -  improve survival~   "
161258|NCT01455259|"~     In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In~     Part 1 patients with melanoma will receive AdCD40L as mono therapy. In Part 2A, patients with~     melanoma and patients with other solid tumors will receive AdCD40L in combination with low~     dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination~     with one local radiotherapy and cyclophosphamide.~   "
161259|NCT01455246|"~     Nosocomial spontaneous bacterial peritonitis (SBP) is frequently caused by multi drug~     resistant bacteria. Standard treatment of SBP could be ineffective. The aim of the study is~     to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial SBP.~   "
161260|NCT01455233|"~     The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and~     tolerance when used prophylactically in subjects undergoing routine cataract surgery.~   "
161261|NCT01455220|"~     The purpose of this study is to determine if sexual dysfunction symptoms and quality of life~     measures in patients with Multiple Sclerosis may be improved in patients that are prescribed~     Tysabri.~   "
161262|NCT01455207|"~     This research project aims to identify factors that contribute to the heterogeneity observed~     in neuroradiological and neuropsychological signs of chronic alcoholism. The investigators~     overarching hypothesis is that the heterogeneity of alcoholic consequences on brain structure~     and metabolism, and cognition is mainly related to individual differences in pattern of~     alcohol use, gene pool, nutritional status and history of withdrawal symptoms.~   "
161263|NCT01455194|"~     The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day.~     Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).~   "
161264|NCT01455181|"~     This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in~     reducing requirements for supplemental oral calcium and active vitamin D, while maintaining~     stable total serum calcium levels in adult subjects with hypoparathyroidism.~   "
161265|NCT01455168|"~     The purpose of this study is to examine the efficacy of a capsular tension ring (CTR) in~     preventing anterior capsule shrinkage after cataract surgery in exfoliation syndrome (XFS)~     with no zonular weakness. The eyes with XFS undergo phacoemulsification and aspiration (PEA)~     with an intraocular lens (IOL) implantation. All operations are performed by a single~     surgeon. No eyes with either ectopia lentis or phacodonesis are included. There are three~     groups; CTR is not used in group A, CTR is simply implanted in group B, and CTR is implanted~     and closed by tying both eyelets in group C. The areas of continuous curvilinear~     capsulorhexis (CCC) are calculated, and both the time-course change and the comparison among~     the 3 groups are tested.~   "
161266|NCT01455155|"~     Stroke is one of the common diseases in the elderly. It is the third ranking cause of death~     and affects health care system in our country. The focal brain lesions encountered in~     patients with stroke can result in impairments in motor function, language, cognition,~     sensory processing, cognition and emotional disturbances. All of these conditions affect~     performance of functional activities. The abrupt change in the life situation of the stroke~     survivor impacts all phases of care. This may reduce a patient's quality of life.~      Many innovative therapy techniques have been developed to help the restoration of lost~     functions and to aid in prevention and treatment of depression. Music and art therapy has~     been used in rehabilitation settings to stimulate brain functions involved in movement,~     cognition, speech, emotions, and sensory perceptions. However many research studies on the~     use of music and art therapy in rehabilitation of acquired brain injury have suffered from~     small sample size, making it difficult to achieve statistically significant results. In~     addition, differences in factors such as study designs, methods of interventions, and~     intensity of treatment have led to varying results.~   "
161267|NCT01455142|"~     This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between~     two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and~     safety obtained with formulation 1 can be assumed identical for formulation 2.~   "
161268|NCT01455129|"~     Chronic obstructive pulmonary disease (COPD) is one of the commonest respiratory diseases.~     During the early stage of COPD, patients only have mild respiratory symptoms or signs which~     may lead to under-diagnosis of the disease. Patients may show poor response to treatment at~     later stages of the disease, associated with higher mortality and incidence of~     re-hospitalization and disability causing burden for both the families and the society.~      So far, there is no large-scale clinical trial on long-term intervention with tiotropium~     bromide (Spiriva) in patients with early stages of COPD (i.e. GOLD Stage I-II COPD or~     asymptomatic COPD). It would be of great significance for COPD prevention and treatment if~     the investigators could prove that tiotropium decreases the lung function decline and~     reverses disease progression in patients with early-stage COPD.~      The investigators objective is to evaluate the efficacy of long-term intervention with~     tiotropium in early stage (FEV1 ≥50% predicted) COPD (difference of trough FEV1, number of~     exacerbations, time to first exacerbation, quality of life, etc) and relevant~     pharmacoeconomic endpoints.~   "
161269|NCT01455116|"~     Septic shock is in critically ill patients is a condition associated with a high rate of~     organ failure and hereto attributable mortality ~45-55% Hypothesis: Mild Induced Hypothermia~     reduces the mortality of critically ill patients with septic shock by reducing organ~     metabolism, counteracting on microcirculatory thrombosis, genetically downregulating tissue~     apoptosis and by reducing bacterial growth rate and toxin production.~   "
161270|NCT01455103|"~     The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on~     the biomarkers measured in the peripheral blood and tumor tissues of subjects with~     unresectable Stage III or IV Melanoma.~   "
161271|NCT01455090|"~     The purpose of this study is to estimate the rate of sustained virologic response (SVR)~     SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks~     post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1)~     infected patients who are prior null responders to pegIFN/ribavirin~   "
161272|NCT01455077|"~     Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters~     (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep~     Apnea (OSA) without comorbidities.~      However, there is not any study evaluating this system when OSA is associated with morbid~     obesity, so the validation of PMS will be very useful in order to properly work-up this~     highly risk population.~      Objective:~      To evaluate the accuracy of level III type of PMS - Stardust™ (STD), on patients with level~     II and III of obesity and high clinical suspicion of OSA.~      Methods:Participants with BMI > 35 kg/m2 and with suspicion of OSA will consecutively be~     selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the~     following order of recordings:~      1) STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for~     subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.~   "
161273|NCT01455064|"~     This research study will test a new investigational continuous glucose monitoring system~     (System). The purpose of this study is to find out about the performance of the System in a~     home use environment over a 15 day period, in people with diabetes.~   "
161300|NCT01454713|"~     Retrospective data collection of the use of Veritas in breast reconstruction surgery~   "
161301|NCT01454700|"~     The purpose of the study is to investigate whether the combination of insulin pump therapy~     and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to~     prevent progression of albuminuria in patients with type 1 diabetes~   "
161274|NCT01455051|"~     A good proportion of patients with chronic lymphocytic leukemia (CLL) can be managed~     effectively with palliative chemotherapy. However, there is a group of younger patients with~     poor risk disease whose life expectancy is significantly reduced. As a result, reduced~     intensity conditioning (RIC) allogeneic hematopoietic cell transplantation (allo-HCT) has~     been investigated as a potentially curative procedure.~      Recently, the European Group for Blood and Marrow Transplantation (EBMT) published a set of~     guidelines suggesting situations where allo-HCT might be considered a therapeutic option for~     CLL patients. Their conclusions were that allo-HCT was reasonable for younger CLL patients~     refractory to fludarabine, relapsing within two years of intensive treatment, or with p53~     abnormalities requiring treatment.~      However, the results with RIC allo-HCT are not entirely satisfactory, and progression-free~     survival after allo-HCT revolves around 35-40% at 3-5 years following allo-HCT. This is due~     to non-relapse mortality, which is significantly associated with the development of~     graft-versus-host disease (GVHD), but also due to disease relapse. These relapses may occur~     early in the course of the transplantation, like any other hematological malignancy, but late~     relapses have also been reported.~      Several strategies have been tested in order to improve these results. The anti-CD20~     monoclonal antibody rituximab, given concomitantly with allo-HCT or donor lymphocyte~     infusions, may reduce graft-versus-host disease and facilitate disease control. This may be~     due, not only to direct cytotoxicity, but also to modulation of GVHD and the graft-versus CLL~     effect (GVCLL). Interestingly, rituximab has been shown to promote the cross-presentation of~     tumor-derived peptides by antigen-presenting cells, thus enhancing the formation of cytotoxic~     T-cell clones and a GVCLL effect. With the addition of rituximab to the conditioning regimen,~     rates at 4 years for current progression-free survival (CPFS) and overall survival were 44%~     and 48%.~      The investigators hypothesize that ofatumumab, having a more potent anti-CLL activity and~     complement-dependent cytoxicity than rituximab, could improve disease control and modulate~     the GVCLL effect more effectively, thus reducing the GVHD rate and subsequently improving the~     non-relapse mortality and progression-free survival in the long term.~   "
161275|NCT01455038|"~     The purposes of this study were: (1) to compare heart rate variability between bipolar~     patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation~     between the severity of subsyndromal depressive symptoms and reduced heart rate variability.~   "
161276|NCT01455025|"~     This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony~     stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute~     myeloid leukemia .~   "
161277|NCT01455012|"~     Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS)~     have been shown to be associated with elevations in Blood Pressure (BP). Rotigotine has been~     shown to effectively reduce the incidence of PLMs in patients with RLS. The current study~     aims to demonstrate that treatment with Rotigotine could help reduce the number of nocturnal~     BP elevations associated with PLMs in patients with RLS.~   "
161278|NCT01454999|"~     This project aims to enhance the emotional and physical well-being of veterans through the~     reduction of smoking by utilizing a web-based, computerized tailored intervention (CTI) with~     feedback messages delivered via cell phone. CTIs have shown increasing promise as useful~     behavior change programs for improved health behaviors. A variety of modalities are to~     deliver personalized CTI information and feedback; however, the ubiquity and sophistication~     of today's wireless mobile technologies represent new modes of delivery for empirically based~     smoking cessation and other behavioral health interventions. The CTI is based on the~     empirically-supported Transtheoretical Model of Behavior Change (TTM). A web-based CTI~     modified for a veteran population will be used to pilot test the effectiveness of the CTI~     alone and CTI plus individualized text messaging enhancements. The pilot study is a~     randomized controlled trial to assess the cell phone's feasibility as an intervention~     modality for changing smoking behaviors. This will be the first study to adapt a smoking~     cessation Internet-based CTI to provide personalized feedback on a cell phone to reduce~     smoking behaviors in military veterans.~   "
161279|NCT01454986|"~     The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose~     of ALXN1007 in healthy volunteers.~   "
161280|NCT01454973|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
161281|NCT01454960|"~     Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of~     multi-drug resistant pathogens may be encouraged by provider prescribing behavior.~     Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum~     antibiotics can lead to the development of resistant strains. Though providers are adequately~     trained to know when antibiotics are and are not comparatively effective, this has not been~     sufficient to affect critical provider practices.~      The intent of this study is to apply behavioral economic theory to reduce the rate of~     antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for~     antibiotics. Specifically targeted are infections that are likely to be viral.~      The objective of this study is to improve provider decisions around treatment of acute~     respiratory infections.~      The participants are practicing attending physicians or advanced practice nurses (i.e.~     providers) at participating clinics who see acute respiratory infection patients. A maximum~     of 550 participants will be recruited for this study.~      Providers consenting to participate will fill out a baseline questionnaire online. Subsequent~     to baseline data collection and enrollment, participating clinic sites will be randomized to~     the study arms, as described below.~      There will be a control arm, with clinic sites randomized in a multifactorial design to up to~     three interventions that leverage the electronic medical record: Order Sets that are~     triggered by EHR workflow containing exclusively guideline concordant choices (SA, for~     Suggested Alternatives); Accountable Justification (AJ) triggered by discordant prescriptions~     that populate the note with provider's rationale for guideline exceptions ; and performance~     feedback that benchmarks providers' own performance to that of their peers (PC, for Peer~     Comparison).~      The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and~     changes in prescribing rates over time.~      The intervention period will be over one year, with a one-year follow up period to measure~     persistence of the effect after EHR features are returned to the original state and providers~     no longer receive email alerts.~   "
161282|NCT01454947|"~     Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of~     multi-drug resistant pathogens may be encouraged by provider prescribing behavior.~     Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum~     antibiotics can lead to the development of resistant strains. Though providers are adequately~     trained to know when antibiotics are and are not comparatively effective, this has not been~     sufficient to affect critical provider practices.~      The intent of this study is to apply behavioral economic theory to reduce the rate of~     antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for~     antibiotics. Specifically targeted are infections that are likely to be viral.~      The objective of this study is to improve provider decisions around treatment of acute~     respiratory infections.~      The participants are practicing attending physicians or advanced practice nurses (i.e.~     providers) at participating clinics who see acute respiratory infection patients. A maximum~     of 550 participants will be recruited for this study.~      Providers consenting to participate will fill out a baseline questionnaire online. Subsequent~     to baseline data collection and enrollment, participating clinic sites will be randomized to~     the study arms, as described below.~      There will be a control arm, with clinic sites randomized in a multifactorial design to up to~     three interventions that leverage the electronic medical record: Order Sets that are~     triggered by electronic health record (EHR) workflow containing exclusively guideline~     concordant choices (SA, for Suggested Alternatives); Accountable Justifications triggered by~     discordant prescriptions that populate the note with provider's rationale for guideline~     exceptions (AJ); and performance feedback that benchmarks providers' own performance to that~     of their peers (PC, for Peer Comparisons).~      The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and~     changes in prescribing rates over time.~      The intervention period will be over one year, with a one-year follow up period to measure~     persistence of the effect after EHR features are returned to the original state and providers~     no longer receive email alerts.~   "
161283|NCT01454934|"~     This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety~     of eribulin with TPC in subjects with advanced and disease progression following at least two~     prior regimens for advanced disease, which should have included a platinum-based regimen.~   "
161284|NCT01454921|"~     This study will develop/adapt a culturally appropriate secondary prevention intervention for~     young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups,~     evaluate its acceptability and feasibility, make appropriate modifications, and manualize the~     intervention in preparation for a full-scale randomized trial.~      Once the intervention is developed/adapted, the sites will pilot the interventions twice to~     enable modifications. The intervention aims to address the following concerns: 1) reducing~     the risk of young women infected with HIV transmitting the virus to their sexual partners,~     and 2) preventing young women infected with HIV from re-infection with a new viral strain or~     co-infection with another sexually transmitted disease (STD). Data will be collected to~     assess the feasibility and acceptability of the newly developed intervention using both~     quantitative and qualitative methods at each iteration.~   "
161285|NCT01454908|"~     The objective of this study is to compare the effect on gait of unicompartmental knee~     arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.~   "
161286|NCT01454895|"~     The purpose of this project is to compare the effectiveness of several approaches to~     influencing hearing protector use. The goals of this study are to further develop an~     intervention to promote farmers' use of hearing protectors, and compare the effectiveness of~     the developed intervention with two alternative approaches to influencing hearing protector~     use behavior, delivered in various combinations. This study will determine if significant~     change in hearing protection use can be achieved in a one-shot web-based or protector-supply~     intervention. Results will determine the need for future program modifications, e.g.,~     inclusion of booster(s).~   "
161287|NCT01454882|"~     Although instruments such as pedometers and heart rate monitors are helpful for those who use~     exercise to maintain their weight, they do not actually measure calories expended, which is a~     critical piece of information necessary for sustained weight management. The purpose of this~     study is to determine the accuracy of a new device that measures calories burned based upon~     heat produced by the body. Since heat production is directly proportional to calories burned,~     this device has the potential to accurately measure energy expended in many different~     settings.~   "
161288|NCT01454869|"~     This is a prospective randomized clinical trial about the efficacy of heparin nebulization on~     lung injury score in inhalation burn injury in Mothary burn hospital. This study would~     consist of 170 burn patients with documented inhalation injury in 2 arms (control group and~     study group). Allocation ratio is1:1. Masking was not possible. The patients' primary outcome~     will be assessed for Lung Injury Scale and the patients' secondary outcome will be assessed~     for mortality, Coagulation tests (PT, PTT), ICU and hospital stay and duration of mechanical~     ventilation support. Duration of this study is about 32 months.~   "
161289|NCT01454856|"~     This study consists of evaluations, using blood tests, various immune, inflammatory and~     coagulation parameters in the perioperative settings (different substudies), without changing~     anything to what is expected.~      This will allow us to clarify the possible impact of surgery and analgesia on perioperative~     activation of these pathways.~   "
161290|NCT01454843|"~     The purpose of the study is to compare the results of LASIK surgery when using Alcon~     Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided~     excimer laser system in patients with nearsightedness with and without astigmatism.~   "
161291|NCT01454830|"~     The purpose of this study is to examine the feasibility of a tailored (i.e., individualized)~     intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in~     adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.~   "
161292|NCT01454817|"~     The purpose of this study is to better understand symptoms and quality of life in patients~     with heart disease and implantable defibrillators (ICDs).~   "
161293|NCT01454804|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combinations of pazopanib and either lapatinib or trastuzumab that can be given to patients~     with advanced cancer. The safety of the drug combinations will also be studied.~      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for~     tumor growth. This may prevent or slow the growth of cancer cells.~      Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking 2~     proteins on the surface of the cancer cell, which are HER 1 and HER 2 receptors.~      Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking~     proteins inside the cancer cell, called the Her2/neu receptor.~   "
161294|NCT01454791|"~     The purpose of this study is to assess the effect of Diclofenac Sodium Topical Gel (DSTG) on~     injection site reaction following self-administer glatiramer acetate in people with Multiple~     Sclerosis.~   "
161295|NCT01454778|"~     This is a single, one time, limited dose infusion of Paclitaxel, that will potentially~     prevent recurrent stenosis secondary to intimal hyperplasia when compared to the control~     group at 10 months.~   "
161296|NCT01454765|"~     Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex~     and therefore limits genetic research approaches in biomedical models. To overcome this~     problem experimental generation of haploid stem cells has been done in animals. The~     investigators aim at generating haploid stem cells from human germ cells that are a useful~     tool in genetic research and screening.~   "
161297|NCT01454752|"~     Although the risk of malaria is greatest in early childhood, significant numbers of~     schoolchildren remain at risk from malaria infection, clinical illness and death. By the time~     they reach school, many children have already acquired some clinical immunity and the ability~     to limit parasite growth, and thus most infections are asymptomatic and will go undetected~     and untreated. Asymptomatic parasitaemia contributes to anaemia, reducing concentration and~     learning in the classroom, and interventions aiming to reduce asymptomatic parasite carriage~     may bring education, as well as health, benefits.~      Intermittent parasite clearance (IPC) delivered through schools is a simple intervention,~     which can be readily integrated into broader school health programmes, and may usefully~     supplement the community-distribution of insecticide-treated nets (ITNs) in countries with a~     policy of universal coverage of nets.~      This study seeks to establish whether intermittent parasite clearance undertaken once a year~     at the end of the malaria transmission season can reduce malaria parasite carriage and~     anaemia amongst school-going children already using insecticide-treated nets, and its~     consequent impact on school attendance and performance, in order to assess its suitability~     for inclusion as a standard intervention in school health programmes in areas of seasonal~     malaria transmission.~   "
161302|NCT01454687|"~     The term epidermolysis bullosa (EB) is used to describe a group of genetic skin diseases~     associated with skin weakness, blisters, and chronic wounds. Revertant mosaicism means that~     there are two genetically different populations of cells due to spontaneous mutations. Some~     EB patients have normal, non-fragile skin patches which may be areas of revertant mosaicism.~     In the revertant areas, the proteins function normally, like non-EB skin. In this study, we~     plan to culture cells from the revertant areas and graft them on to the wounded areas.~   "
161303|NCT01454674|"~     The investigators have designed a three dose level, cross-over vegetable feeding study using~     expertise from nutritional sciences and plant sciences to:~        1. Implement a randomized vegetable feeding trial among overweight post- menopausal women~        2. Produce, in a controlled environmental setting, vegetable crops which provide a selected~          variety and quantity of carotenoid and nutrient exposure~        3. Assess changes and hopefully demonstrate a significant reduction in oxidant stress and~          inflammation in this population at risk for developing chronic disease~   "
161304|NCT01454661|"~     Probiotics are live microbes which, when administered in sufficient amounts, confer a health~     benefit to the host. According to recent clinical trials, administration of probiotics to~     very low birth weight infants significantly reduces overall mortality and risk of necrotizing~     enterocolitis, a devastating inflammatory intestinal disease. The investigators have~     previously demonstrated that administering probiotics to the lactating mother enhances the~     immunoprotective properties of breast milk. Despite the promising data, the optimal probiotic~     intervention is yet to be established. The mechanisms by which probiotics exert their effects~     remain largely unknown.~      This research project is based on the notion that modulation of early microbial contact by~     probiotics may provide a safe and effective means to improve the health of preterm infants.~     In particular, the investigators hypothesize that the protective potential of probiotics may~     be enhanced via breast milk by administering probiotics to the lactating mother. All of the~     potentially beneficial effects of probiotic bacteria are strain-specific and therefore~     preliminary laboratory and clinical research with regard to different physiological targets~     of probiotic intervention should be carried out to guide the design of large-scale clinical~     trials aiming show clinical efficacy and establish clinical practice. The purpose of this~     research project is to identify targets for probiotic therapy in premature neonates and to~     provide insight into the optimal probiotic strains and administration protocol the clinical~     efficacy of which will subsequently be tested in a randomized controlled trial.~      The specific aims of the project are:~        1. To determine the effect of maternal consumption of probiotics during lactation on~          immunomodulatory properties of breast milk in mothers of premature infants.~          Concentrations of immunomodulatory factors and microbiological properties of breast milk~          will be measured.~        2. To investigate the impact of different probiotic administration protocols on gut~          microbiota composition in preterm infants. In particular, the issue whether maternal~          probiotic consumption instead or in addition to probiotics administered to the infant is~          effective will be elucidated. Different potential probiotic strains will be assessed.~        3. To elucidate the impact probiotic bacteria administered to the lactating mother and/or~          directly to the infant on gut immunophysiology in preterm infants.~   "
161305|NCT01454648|"~     The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment~     methods on traumatic brain injury (TBI) patient prognosis.~   "
161306|NCT01454635|"~     The purpose of this study is to predict and visualize sertraline treatment response in major~     depressive disorder with clinical symptoms, demographic and stress state, personality, eight~     genetic polymorphisms at baseline.~   "
161307|NCT01454622|"~     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)~     tablets of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of canagliflozin and metformin IR.~   "
161308|NCT01454609|"~     With thyroid surgery being performed as an ambulatory procedure, most recent studies~     concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral~     superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep~     cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence the~     investigators compared the efficacy of BSCPB with 0.25% bupivacaine with or without clonidine~     in thyroidectomy, as preemptive analgesia.~      The hypothesis was bupivacaine with the addition of clonidine would help in reducing~     postoperative pain and thereby reduce the need for postoperative analgesia.~   "
161309|NCT01454596|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     gliomas that involves taking white blood cells from the patient, growing them in the~     laboratory in large numbers, genetically modifying these specific cells with a type of virus~     (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient.~     This type of therapy is called gene transfer. In this protocol, we are modifying the patient~     s white blood cells with a retrovirus that has the gene for anti-EGFRvIII incorporated in the~     retrovirus.~      Objective:~      The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these particular tumor-fighting cells (anti-EGFRvIII cells) are a safe and effective~     treatment for advanced gliomas.~      Eligibility:~      - Adults age 18-70 with malignant glioma expressing the EGFRvIII molecule.~      Design:~      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo~     a history and physical examination, scans, x-rays, lab tests, and other tests as needed~      Leukapheresis: If the patients meet all of the requirements for the study they will undergo~     leukapheresis to obtain white blood cells to make the anti-EGFRvIII cells. {Leukapheresis is~     a common procedure, which removes only the white blood cells from the patient.}~      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the~     conditioning chemotherapy, the anti-EGFRvIII cells, and aldesleukin. They will stay in the~     hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans every month for the first year, and then every 1-2 months as long as~     their tumors are shrinking. Follow up visits will take up to 2 days.~   "
161310|NCT01454583|"~     In Germany nearly half of the population present elevated values of blood pressure, with - as~     a result of lifestyle factors and a growing average age - further increasing numbers.~      Consequences of arterial hypertension may be cardiovascular diseases, cerebrovascular events,~     and renal insufficiency. Thus, hypertension therapy focuses on the reduction of these~     complications.~      The aims of the 3A-registry are the characterization of outpatients with hypertension, their~     diagnostic procedures and medical treatment (esp. with renin inhibitors), therapy compliance~     and success, clinical events, and an assessment of overall guideline adherence in the~     treatment of these patients.~      Patients fulfilling the relevant criteria are enrolled and followed up by their general~     practitioner or medical specialist.~   "
161355|NCT01453998|"~     The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the~     booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15~     months of age, and the immune persistence following the primary series. All children in this~     booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948~     (NCT01248884). No new subjects will be enrolled in this booster study.~   "
161311|NCT01454570|"~     It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to~     many secondary medical problems such as diabetes and insulin resistance, obesity,~     constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of~     life, and more. The ReWalk-I exoskeleton walking device permits investigation of the~     potential benefits of frequent upright posture and walking on many of the secondary~     consequences of spinal cord injury. The researchers are investigating the ability of persons~     with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright~     and walking on several of these secondary medical consequences of spinal cord injury.~   "
161312|NCT01454557|"~     Heart Rate Variability (HRV) reflects the responsiveness of the autonomic system to an~     external stimuli. The aim of this system is to maintain homeostasis.The variability implies~     on the interaction between the sympathetic and the parasympathetic systems to maintain the~     ongoing changes of the autonomic system. Following Acquired Brain Injury (ABI), there can be~     a damage to the Central Nervous System (CNS) function. The damages described in the~     literature are cognitive, motor and behavioural function, while there is less relation to the~     autonomic system. The autonomic system can influence the ability of patient with ABI to~     participate in the rehabilitation program. The aim of this work is to investigate the~     activity of the autonomic system activity as manifested by HRV among patients with ABI in~     different conditions: resting, during activity and while listening to different auditory~     stimuli.~   "
161313|NCT01454544|"~     The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet~     given once daily compared to a placebo tablet in the treatment of house dut mite allergic~     rhinits.~      Additionally the secondary objective of the trial is to evaluate the safety and tolarability~     of the ALK house dust mite tablet.~      Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite~     induced allergy. This trial is planned to investigate if clinically relevant improvements in~     rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects~     with a history of poor didease control despite of use of symptomatic medications.~   "
161314|NCT01454531|"~     The purpose of this study is to assess the tolerability of AVANZ.~   "
161315|NCT01454518|"~     The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic~     solution around the hip joint will provide effective pain control after hip arthroscopy.~   "
161316|NCT01454505|"~     The purpose of this study was to determine the maximum tolerated dose of AL-53817 (Stage A)~     and evaluate the safety and efficacy of AL-53817 for the treatment of allergic rhinitis~     (Stage B).~   "
161317|NCT01454492|"~     Allergic rhinitis is a complex chronic inflammatory disease, it always presents with nasal~     obstruction, nasal itching, sneezing and runny nose. Whether in adults or children, rhinitis~     is a complex disease. The prevalence of allergic rhinitis in Taiwan is about 24-29%. Taiwan~     is a developing country. It is a hot and humid country. In developing countries,~     industrialization, air pollution makes the constantly increasing number of patients with~     rhinitis. Penghu in 1994 for children aged 7 to 14 by the study found that among 7599 people,~     1766 people have allergic rhinitis, about 23.2%. Allergic rhinitis is a complex chronic~     disease. So, it become a diagnostic challenge, its prevalence always underestimated. The~     prevalence of rhinitis has increased in recent years. The phenomenon of underestimate is~     caused by variety of personal and environmental factors. Allergic rhinitis had increased~     direct and indirect social and economic burden.~      Geographic tongue is a benign tongue performance. Geographic tongue has been reported their~     relevance to allergy. Geographic tongue is a chronic tongue situation. The causes of~     geographic tongue still remains unknown. Allergic rhinitis is a diagnostic challenge to~     clinicians. The investigators hope that geographic tongue could play a role in the diagnostic~     of allergic rhinitis. The prevalence of geographic tongue in the United States is about 1.8%,~     white Americans and Mexicans have a higher incidence rate. This study will investigate the~     relevance between allergic rhinitis and geographic tongue. The investigators will analyze the~     relevant gender, age, severity of inspection reports. The research results wound provide an~     important reference to the diagnosis of allergic rhinitis.~   "
161318|NCT01454479|"~     Endometrial cancer (EC) is the 8th most common female cancer in Taiwan. Its incidence is~     increasing in the recent few years, around 1,200 new cases per year. The outcome of recurrent~     EC is disappointing, except focal recurrences that could be irradiated or removed.~     Chemotherapy is currently the most common salvage treatment for recurrent endometrial cancer.~     However, the response rate (RR) to 2nd-line treatment is approximately 0-27.3%, with short~     median time to progression, 2-3.9 months and low overall survival, 6.4-11 months.~      Due to progress of studies on the molecular and genetic basis of cancer and cellular~     signaling pathways, targeted therapy has been developed for various cancer treatments. A~     Gynecologic Oncology Group study found 44% of advanced endometrial cancer had HER>=2+ and the~     ratio of HER2:chromosome 17 (CEP17) >=2. Another study showed that HER>=2+ was seen in 47% of~     carcinosarcoma. These evidences indicated HER2 gene amplification and HER2 overexpression~     occur in endometrial cancer and carcinosarcoma, especially in those of high grade and~     recurrence. Lapatinib (L), an oral inhibitor of both EGFR(epidermal growth factor receptor)~     and HER2(human epidermal growth receptor), has been shown to be an effective treatment in~     HER2/neu overexpressing metastatic breast cancer. Ixabepilone is a semisynthetic analog of~     the natural product epothilone B, and recently has been approved by US Food and Drug~     Administration as a treatment option in metastatic breast cancer. It was also observed that~     lapatinib + ixabepilone killed more breast tumor cells than trastuzumab + paclitaxel in~     vitro. Two GOG(Gynecologic Oncology Group) studies had reported that weekly Ixabepilone as~     2nd-line chemotherapy provided a similar RR to 3-weekly regimen of 14.3% in platinum- and~     taxane-resistant epithelial ovarian cancer with less severe toxicities. The combination of~     lapatinib and ixabepilone is expected to become an effective treatment for recurrent~     endometrial cancer and carcinosarcoma, but the ideal dose is yet to be surveyed.~   "
161319|NCT01454466|"~     To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal~     breaks related to induction of a posterior vitreous detachment~   "
161356|NCT01453985|"~     This is a prospective study to extensively evaluate subjective patient parameters on quality~     of life, reflux-symptoms, side effects, medication-use and measurements of esophageal~     manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.~   "
161357|NCT01453972|"~     The main purpose of our study is to examine the physiological adaptations in oxygen transport~     chain for high-intensity exercise and moderate exercise in overweight and obese humans. The~     main goals are:~        1. To investigate the most effective short-and long-interval training in terms of VO2max,~          pulmonary diffusion, cardiac output, endothelial function and mitochondrial function.~        2. How these physiological adaptations affect the aerobic endurance and performance, and~          how this training can reduce the risk of cardiovascular diseases related to overweight~          and obesity.~   "
161358|NCT01453959|"~     The main hypothesis of this study is look for a clinical and fast test to identify salt~     sensitivity by administration of fludrocortisone.~   "
161320|NCT01454453|"~     Drugs such as amisulpride, known as antipsychotic drugs, are used to treat troublesome and~     distressing symptoms in older people. Although these drugs can be beneficial, they are~     associated with side effects, particularly in patients with dementia and schizophrenia- like~     illness. There is an urgent clinical need to understand why this is the case, to guide~     treatment strategies.~      This study aims to utilise brain imaging techniques that measure the action of antipsychotic~     drugs in the brain to explore the causes of this susceptibility in older people with dementia~     and schizophrenia-like illness, and translate these findings into direct patient benefit.~      The aim of the study is to investigate and compare the relationship between the action of~     amisulpride at brain sites during the first 10 weeks of amisulpride treatment in two patient~     groups - Alzheimer's disease and schizophrenia-like illness. Imaging data will be combined~     with data on drug dosage, levels of drug in the bloodstream and clinical response (symptom~     reduction and motor side effects) during dose titration.Dose-response modelling will be~     carried out in both groups to establish the minimum clinically effective dose of amisulpride,~     optimum dose range and impact of variability and covariates on exposure-response~     relationships~   "
161321|NCT01454440|"~     Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33~     mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin~     according to the ESPRIT protocol vs placebo plus unfractioned heparin.~   "
161322|NCT01454427|"~     Impedance aggregometry (IA) (Multiplate®)is a new whole blood platelet function test with~     potential use in anesthesia and intensive care. Most anesthetic drugs have been shown to have~     in vitro antiplatelet activity. The goal of this in vitro study is to evaluate the effect of~     several drugs, frequently used in cardiac anesthesia and intensive care, on platelet function~     as measured by IA~   "
161323|NCT01454414|"~     The high risk of acquiring tick-borne diseases by outdoor workers is well documented. Workers~     most at risk include, foresters, park rangers, land surveyors and other outdoor workers have~     frequent exposure to tick-infested habitats. Many North Carolina state employees with outdoor~     occupations report multiple tick bites each year, which indicates that existing tick~     preventive strategies may be ineffective. The principal goal of this study is to assess~     whether the use of long-lasting permethrin impregnated uniforms can reduce the number of tick~     bites sustained by North Carolina outdoor workers.~   "
161324|NCT01454401|"~     The LeucoPatch™ study goal is to investigate whether the fully autologous growth~     factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic~     foot ulcers. The study seeks to gather data for comparison with previous data from similar~     wounds (historical controls). By subgrouping of the treated wounds (similar to the historical~     controls used) an assessment of which of the patient and wound-related factors that might~     indicate a beneficial effect of LeucoPatch™ is sought.~   "
161325|NCT01454388|"~     In addition to bowel cleansing agents, the current practice of bowel preparation for~     colonoscopy involves a low residue diet 48 hours prior to and a clear fluid diet the day~     before the procedure. This study aims to test whether patients who consume a low residue~     breakfast the day prior to colonoscopy have a difference in the quality of their bowel~     preparation. Patients requiring outpatient colonoscopies will be asked to participate. They~     will be randomized to either breakfast or no breakfast the day before the procedure. Colon~     cleanliness, patient hunger, and tolerance will be assessed.~      The investigators hypothesize that there will be no difference in bowel preparation scores~     and will be better tolerated~   "
161326|NCT01454375|"~     Tobacco smoke claims approximately 6000 lives annually in BC. In this study, the~     investigators will determine whether referring smoking patients from the Vancouver General~     Hospital Emergency Department to the investigators provincial QuitNow smoking cessation~     service will lead to improved patient outcomes, including number of cigarettes smoked, any~     quit attempts, and actual smoking cessation.~      Participants in the usual care arm will receive standard care. Participants in the~     intervention arm will be eligible for referral to QuitNow Services, where telephone~     counseling will be offered. Further follow-up on all enrolled patients will be conducted at~     1, 3, 6, and 12 months to re-assess smoking status.~      The investigators hypothesis is that the intervention arm will have a higher quit rate that~     the control arm.~   "
161327|NCT01454362|"~     Study rationale: Sensory/behavioural elements of smoking play a role in smoking behaviour and~     may have a potential to assist smoking cessation. Among current treatments for smokers, only~     the nicotine inhalator is attempting to address such factors. The inhalator's efficacy does~     not exceed that of the other NRT products, but it mimics the relevant sensory input to only a~     limited extent, and its nicotine delivery is dependent on intensive puffing. Recently a new~     product, the Electronic Cigarette (E-C) has become available, which provides a more realistic~     behaviour and sensory replacement for smoking and can provide good nicotine levels with less~     effort.~      Primary objective: To compare E-C and nicotine inhalator in their effects on tobacco~     withdrawal symptoms over 24hr abstinence.~      Hypotheses: E-C will be more effective than the inhalator in reducing withdrawal symptoms and~     craving and elicit more favorable user ratings. It will also provide higher nicotine levels.~      Study design: In a cross-over study, participants will be randomized to the sequence of~     conditions and provide baseline measures and samples for salivary cotinine analysis. They~     will be asked to abstain from smoking their usual cigarettes and use the allocated product~     over 24 hours. They will return to the study centre the following day, and complete measures~     of craving and withdrawal, ratings of subjective and sensory effects of the products, product~     satisfaction, and adverse effects. They will also provide saliva samples for cotinine~     analysis. Abstinence from smoking will be verified with CO readings.~   "
161328|NCT01454349|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of a single~     treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to~     placebo.~   "
161329|NCT01454336|"~     Liver cirrhosis (LC) is the final destiny in chronic liver disease. Liver transplantation is~     the only effective therapy available to these patients. However, limited number of donors,~     post surgical complications, immunological rejection, and financial considerations are it`s~     essential problems. The immuomodulatory impact of MSCs in fibrosis was confirmed, and several~     clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research~     the investigators will study the affect of MSCs and Pioglitazone in the process of fibrosis.~   "
161359|NCT01453946|"~     A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.~   "
161330|NCT01454323|"~     Phase II clinical trial which will include all patients diagnosed with chronic anterior~     myocardial infarction (more than 6 months from the acute phase and the complete~     revascularization in which it is assessed the evolution of left ventricular function in~     patients to the monitoring against their own basal condition.~      Included patients will be studied in the following conditions:~        -  Basal condition: defined as the immediately preceding to the administration of cell~          therapy treatment.~        -  Monitoring Condition 1: three months after drug administration of cell therapy. Includes~          non-invasive methods of exploration of ventricular function.~        -  Monitoring Condition 2: six months after administration of treatment. Includes the same~          methods of exploration of ventricular function practised in the basal condition,~          including cardiac catheterism as well as non invasive methods.~        -  Monitoring Condition 3: twelve months after administration of the cell therapy drug.~          Includes non-invasive methods of exploration of ventricular function.~      The trial hypothesis we propose consists of mononuclear cells of bone marrow providing~     progenitor cells with regenerative capacity and also secreting several angiogenic factors,~     and their implantation into ischemic tissues should contribute with both elements to the~     angiogenesis and tissue regeneration with myocardial functional recovery~   "
161331|NCT01454310|"~     The purpose of the study is to compare an acellular epithelial skin substitute with~     autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective~     is to evaluate skin quality and scar formation by using subjective and objective burn scar~     assessments in order to present valuable data for another additional option of wound coverage~     in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial~     skin substitute is at least not inferior to autologous skin grafts.~   "
161332|NCT01454297|"~     The primary objective of this observational study is to identify the molecular profiles and~     clinical characteristics that define subsets of myeloma patients during the course of the~     disease.~   "
161333|NCT01454284|"~     The purpose of this study is:~        -  To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of~          treatment.~        -  To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin~          glargine during 52 weeks of treatment.~        -  To compare the number of participants on LY2605541 reaching blood sugar targets without~          low blood sugar episodes at night to those taking insulin glargine after 52 weeks of~          treatment.~        -  To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine~          during 52 weeks of treatment~   "
161334|NCT01454271|"~     The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to~     be less than 1% but remains a severe and costly complication, source of morbidity and even~     mortality. The biofilm forms very early after the bacterial contamination of the prosthesis~     and poses a number of clinical challenges due to his resistance to immune defence mechanisms~     and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS)~     is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene~     sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also~     proved his biocompatibility and osseous-integration.~   "
161335|NCT01454258|"~     This study evaluates which substitution solutions are used in daily clincal practice in~     various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region).~     Furthermore the indication for usage of these solutions is investigated.~   "
161336|NCT01454245|"~     The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of~     a single dose of 3 capsule formulations of JNJ-39439335 in healthy adult male volunteers. The~     effect of food on the pharmacokinetics of one of the capsule formulations of JNJ-39439335~     will also be evaluated during the study.~   "
161337|NCT01454232|"~     Gut microbiota ecology is altered in obesity and could link obesity and its complications.~     Bariatric surgery enables a major and sustained weight loss therefore improving obesity~     related disease.~      the investigators primary aim is to evaluate gut microbiota adaptation to weight loss and the~     specific role of energetic restriction. Furthermore we aim to compare gut flora of obese~     patients post bariatric surgery to that of lean healthy volunteers.~      Thus, the investigators plan to compare gut microbiota from 140 obese individuals before and~     after either restrictive (gastric banding) procedures or gastric bypass procedures to that of~     40 lean healthy volunteers at baseline.~   "
161338|NCT01454219|"~     This study aims to determine the glycemic index, glycemic load and insulin index of eleven~     Fazer bakery and confectionary products.~   "
161339|NCT01454206|"~     The Goal of this project is to integrate a previously-tested internet-facilitated Screening,~     Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use~     into a large network of primary care offices, the Pediatric Practices of Children's Hospital~     Boston (PPOC).~   "
161340|NCT01454193|"~     The objectives of the data search is to find out if there is correlation between pre, post~     serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and~     associated changes in pre and post systolic and diastolic blood pressure, mean arterial~     pressure, number of blood pressure medications and adherence to 3 times per week dialysis,~     mortality.~   "
161341|NCT01454180|"~     The purpose of this study is to determine the proportion of patients alive after 12 months of~     the beginning of the trial in patients with advanced pancreatic carcinoma individually~     selected and grouped according to the expression in tumor tissue for therapeutic targets.~   "
161342|NCT01454167|"~     Objective- The purpose of this study is to evaluate a connection between~     PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacuum drains of different plastic~     operational wounds and its relation to infections and seroma formation.~   "
161343|NCT01454154|"~     This is a randomized, double-blind, placebo-controlled, multi-institutional study of IV~     RP-1127 (Glyburide for Injection) begun within 10 hours of complicated mild, moderate or~     severe traumatic brain injury (TBI).~   "
161373|NCT01453764|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Multiple~          Sclerosis and clinical outcomes?~   "
161411|NCT01453270|"~     The purpose of this study is to determine whether the use of a 3-hour protocol utilizing~     non-invasive hemodynamic optimization treatment strategy results in better outcome and lower~     hospital costs in patients who present with severe bloodstream infections to the Emergency~     Department (ED).~   "
161344|NCT01454141|"~     Depression is frequently characterized by patterns of inflexible, maladaptive, and ruminative~     thinking styles; these patterns themselves are thought to result from a combination of~     decreased attentional control, decreased executive functioning, and increased negative~     affect. Specifically, the dorsolateral prefrontal cortex has been hypothesized to play a~     central role in emotion regulation by recruiting resources necessary for executive control.~     Recent advances have been made in neurobehavioral training strategies as interventions for~     emotional disorders such as depression. Cognitive control training (CCT) uses computer-based~     exercises to recruit and activate prefrontal neural networks via repeated behavioral~     exercises, with the aim of strengthening cognitive and emotional functions. A previous study~     found that severely depressed participants who received CCT exhibited reduced negative affect~     and rumination as well as improved focus and concentration. The present study aimed to extend~     this line of research by employing a more stringent control group and testing the efficacy of~     three sessions of CCT over a two-week period in a community population with depressed mood.~     Forty-eight participants with high BDI-II scores were randomized to CCT or a comparison~     condition (Peripheral Vision Training; PVT). The investigators hypothesized that relative to~     a control condition (PVT), CCT would be associated with less self-reported negative mood and~     emotional reactivity.~   "
161345|NCT01454128|"~     Heart failure (HF) is a complex syndrome characterized by myocardial dysfunction and an~     impaired regulatory function of multiple organ systems which were resulted from impaired~     cardiac output and consequently impaired perfusion of target organ. In cardiopulmonary~     exercise test (CPET), the investigators found there is periodic oscillation in minute~     ventilation of some patient. With periodic breathing (PB), clear oscillations in oxygen~     uptake, carbon dioxide output, tidal volume and left ventricle ejection fraction (LVEF) were~     also noted. Exertional hyper-ventilation that is caused by HF may further induce~     vasoconstriction during exercise and lead to further dysfunction of end-organ and muscle.~     Reduced end-organ perfusion/oxygenation may critically limit exercise performance. Hypoxic~     change during nadir phase of PB may deteriorate the exercise limitation. Physical training~     can have beneficial effects which can effectively counteract the progression of deleterious~     compensatory mechanisms of HF. Whether exercise yields the same beneficial effect on~     ventilation oscillation and inefficacy is not clear.~      The investigators will observe the real-time cardiac and hemodynamic change respond to~     exercise with periodic breathing change. The investigators expect that these results obtained~     from this study can aid in determining appropriate exercise intervention to improve aerobic~     fitness as well as simultaneously improve hemodynamic control in patients with HF. A~     quasi-experimental design will be used in this investigation. 60 HF patients will be~     recruited from Chang Gung Medical Foundation, Keelung Branch after they have provided~     informed consent. These subjects will be divided into PB (n=30) and non-PB groups (n=30) by~     their expression of CPET. Patients from each groups received the same therapy and trace~     course for 2years including CV clinics, CPET and polysomnography. The investigators will~     measure subjects' physical fitness, oxygen transport and utilization of exercising skeletal~     muscles, cardiovascular functions and hemodynamics, blood cell parameters, RBC deformity and~     aggregation, plasma biomarkers of myocardial damage, oxygen stress and quality of life at~     pre-training stage and following the 6th , 12th, 18th, 24th months of the tracing program.~     Experimental results were analyzed by descriptive statistics, independent t-test, and~     repeated measure ANOVA. The investigators study the above parameter to realize the~     physiological response to exercise of these patients and discover the appropriate exercise~     intensity for prescription for EPB.~   "
161346|NCT01454115|"~     The primary objective is to assess the safety and tolerability of a single oral dose of~     BMS-708163 in healthy young male subjects and in elderly male and female subjects.~   "
161347|NCT01454102|"~     There is no formal research hypothesis to be statistically tested in this protocol.~        -  The study is evaluating the safety and tolerability of Nivolumab (BMS-936558) when~          combined with three platinum-based doublet chemotherapy regimens (Cisplatin/Gemcitabine;~          Cisplatin/Pemetrexed; and Carboplatin/Paclitaxel) in subjects with NSCLC.~        -  The study is evaluating the safety and tolerability of Nivolumab as maintenance therapy~          in combination with Bevacizumab/Avastin that will be given after at least 4 cycles of~          platinum doublet chemotherapy.~        -  The study is evaluating the safety and tolerability of Nivolumab in combination with~          Erlotinib among epidermal growth factor receptor (EGFR) mutation positive non-squamous~          NSCLC subjects and as monotherapy in subjects with NSCLC.~        -  The study is evaluating the safety and tolerability of Nivolumab in combination with~          Ipilimumab in subjects with squamous and non-squamous NSCLC.~        -  The study is evaluating the safety and tolerability of Nivolumab as switch maintenance~          therapy in subjects with squamous and non-squamous NSCLC.~        -  The study is evaluating the safety and tolerability of Nivolumab as monotherapy among~          subjects with untreated, asymptomatic brain metastases and no evidence of cerebral~          edema.~   "
161348|NCT01454089|"~     The primary objective of this study is to ascertain whether there is evidence of longer~     survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control~     Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to~     control Arm.~   "
161349|NCT01454076|"~     This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB~     designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative~     bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug~     interaction with rifampin (Arm 4), and drug-drug interaction with clarithromycin (Arm 5) in~     participants with advanced nonhematologic malignancies or lymphoma.~   "
161350|NCT01454063|"~     The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug)~     for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens~     Replacement (ILR) surgery.~   "
161351|NCT01454050|"~     The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family.~     Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which~     automatically measures the RV/LV threshold and subsequently adjusts the pacing output.~   "
161352|NCT01454037|"~     The change of immune profiles and existence of circulating tumor cells following prostate~     cryotherapy may be correlated with the clinical outcome.~   "
161353|NCT01454024|"~     This study is conducted in Asia. The aim of of this study is to evaluate the safety of~     NovoPen® 3 and/or FlexPen® devices (if available on the market) measured by the number of~     adverse events and technical complaints in patients with type 1 and type 2 diabetes in~     routine clinical practice.~   "
161354|NCT01454011|"~     The study is designed to answer the following questions:~        1. Is there any difference between the compositions of the HDL cholesterol subpopulations~          of patients with hypogonadism and the healthy controls.~        2. What is the effect of testosterone replacement therapy on the distributions of HDL~          subgroups.~        3. Is there any difference between the effects of the two different testosteron replacement~          regiments~   "
161387|NCT01453582|"~     The purpose of this study is to confirm the efficacy and safety of total flavonoids of~     propolis dropping pill to treat angina pectoris, evaluated by total exercise time of~     treadmill exercise test.~   "
161360|NCT01453933|"~     Treatment with HIV-infection with protease inhibitors is associated with high blood lipids~     and higher chance for cardiovascular complications. The RASSTER study aims to investigate the~     effect of switching the protease inhibitor lopinavir/ritonavir to raltegravir on vessel wall~     function and inflammation,and activation of the immune system. we hypothesize that with this~     intervention these parameters will improve. Since decreased vessel wall function and~     inflammation are initial steps in the process of atherosclerosis, it is important to know~     this data when treating HIV-infected patients.~   "
161361|NCT01453920|"~     The current norm in clinical practice for the treatment of choroidal neovascular membranes~     (CNVM) secondary to Age-related Macular Degeneration(AMD) involves monthly injections of~     Ranibizumab until the disease is stabilized. At this point, most physicians tend to follow~     one of two treatment regimens. 'Treat -and-observe' entails regular follow-up of stable~     patients, with treatment thereafter only in the presence of disease recurrence.~     Alternatively, in a 'treat-and-extend' dosing strategy, intervals between treatments are~     extended as long as disease remains stable. Many clinicians, who employ a treat-and-extend~     dosing regimen, do not extend their treatment intervals beyond 3 months. However, it is~     possible that the subgroup of patients on every three months 'treat-and-extend' dosing may~     represent a uniquely, stable population that would perform particularly well on an~     observational regimen with regular follow-up. We hypothesize that there will be a low CNVM~     recurrence rate in wet AMD patients stable on every three months Ranibizumab dosing~     ('treat-and-extend'), who begin a treat-and-observe protocol.~   "
161362|NCT01453907|"~     This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to~     65 years of age. Three cohorts will be studied with subjects receiving ETI-204. This study~     will be randomized, double-blind and stratified by gender. Each cohort will contain 36~     subjects (including at least four females), 30 who will receive ETI-204 and six who will~     receive placebo.~   "
161363|NCT01453894|"~     The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC)~     screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults,~     beginning at age 50 and continuing until age 75. However, rates of CRC screening remain~     inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening.~     Screening rates are even lower among Black and Hispanic populations and in areas with higher~     poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be~     effective. Few studies have examined the rate of repeat FOBT testing; to the investigators~     knowledge, none have been conducted in populations with high prevalence of barriers to~     screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The~     assumption that FOBT is an effective CRC screening strategy presumes it will be done at least~     biennially, and cost-effectiveness studies of CRC screening strategies have found that the~     results are sensitive to the rate of adherence. The investigators study will provide critical~     information for providers and policymakers as they consider optimal strategies to increase~     CRC screening among vulnerable populations.~      Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal~     occult blood testing (FOBT).~      Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a~     30-month period~      Hypothesis 1: Compared to usual care, the intervention will increase the proportion of~     patients who complete a repeat annual FOBT within 6 months of their due date.~      Hypothesis 2: Compared to usual care, the intervention will increase the proportion of~     patients who complete 2 additional FOBTs over the 30-month intervention period.~      Aim 2: Explore perceived barriers to screening among patients who received the intervention~     but did not complete repeat FOBT testing within 18 months~      Aim 3: Assess the costs of the intervention and the costs per additional repeat screening~     compared to patients who received usual care.~   "
161364|NCT01453881|"~     Adequate pharmacological treatment controls symptoms in most asthmatics. Pressurized metered~     dose inhalers (pMDI)are the most used drug delivery devices. Valved holding chambers of~     different types and sizes have also been developed for use in combination with pMDI. The~     therapeutic efficacy of treatment depends on the amount of inhaled particles. The chambers~     can optimize lung deposition as it obviates lung-hand coordination and retain larger~     particles. The aim of this study is to compare the efficacy of the fine particle combination~     pMDI Beclomethasone/Formoterol in asthma control,with or without the aid of a spacer in~     patients without adequate asthma control on medium to high-dose inhaled steroids associated~     with long acting beta adrenergic drugs. The hypothesis is that there is no clinical efficacy~     difference between the two forms of drug administration.~   "
161365|NCT01453868|"~     Standing Balance, with and without blindfold, will be measured on patients with Multiple~     Sclerosis using a Biodex Balance Scale.~      A Twelve week intervention with one non impact aerobics group and one control group will be~     performed.~      Standing balance will then be retested on all subjects and the results will be statistically~     compared.~   "
161366|NCT01453855|"~     The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy~     of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or~     ocular hypertension.~   "
161367|NCT01453842|"~     Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1~     (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol~     (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test~     the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a~     significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals~     containing of olive oil or carbohydrates alone.~   "
161368|NCT01453829|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients after Stroke and~          clinical outcomes?~   "
161369|NCT01453816|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Renal Failure~          and clinical outcomes~   "
161370|NCT01453803|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Parkinson's~          Disease and clinical outcomes.~   "
161371|NCT01453790|"~     This project is an investigator-initiated, randomized-controlled trial of the effectiveness~     of written and verbal parent-specific depression education and motivational advice in~     increasing participants self-disclosed intention to seek follow-up care for possible~     depression symptoms. The control condition is written and verbal general depression education~     and advice. Hypothesis: the office-based experimental intervention of written and verbal~     parent-specific depression and emotional health education and motivational advice increases~     intention to seek follow-up services for emotional health or depression, when compared to~     written and verbal general depression education and advice.~   "
161372|NCT01453777|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with diffuse brain~          lesions and clinical outcomes.~   "
161374|NCT01453751|"~     This will be an open-label, non-randomized, multi-center, patient sponsored study of~     Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion.~      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed Type II Diabetes Mellitus.~   "
161375|NCT01453738|"~     This trial is planed to study if allogeneic mesenchymal stem cells would be safe and~     beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of~     stem cells will be used in this study.~   "
161376|NCT01453725|"~     This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in~     participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to~     receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and~     at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity~     of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg~     subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2,~     the participants were to be told they were receiving active study drug. The primary~     hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to~     placebo as measured by the proportion of participants achieving an Assessment in Ankylosing~     Spondylitis (ASAS) 20 response at Week 16.~   "
161377|NCT01453712|"~     The objective of this study is to compare a standard coronary CT angiography scan protocol~     with conventional image reconstruction with a scan protocol using reduced tube current and a~     new image reconstruction algorithm. The investigators hypothesize that the image quality of~     the new scan protocol is not inferior, while radiation dose estimates are reduced by around~     30%.~      Secondary endpoints of the study include quantitative image quality parameters, prevalence of~     non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics~     (calcified, non-calcified, mixed) and prevalence of follow-up examinations.~   "
161378|NCT01453699|"~     The purpose of this study is to examine how the death of a parent as a child, adolescent or~     young adult affects health and psychosocial wellbeing in adult life and to evaluate the~     impact in adult life of counseling to children, adolescents and young adults who lost a~     parent.~   "
161379|NCT01453686|"~     The use of topical steroids in the treatment of alopecia areata in children is common~     practice. However, no particular potency of steroid is accepted as the standard treatment due~     to the paucity of high quality evidence in the dermatology literature to substantiate their~     use. Two randomized controlled trials exist assessing topical steroid efficacy in this~     disorder, both have methodological limitations. The question remains as to which topical~     steroid is safe and efficacious for use. We performed a double blinded controlled trial to~     assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0.05%) compared~     with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.~   "
161380|NCT01453673|"~     This study is a retrospective review of chart. Clinical results including range of motion,~     muscle power and scores will be recorded. Arthrocopic surgery of cruciate ligament and~     meniscus will be re-evaluated for clinical application.~   "
161381|NCT01453660|"~     Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers,~     including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are~     side effects. One of the possible long-term side effects of cisplatin is thought to be heart~     disease. The way that cisplatin causes heart disease is not well understood. One possibility~     is that cisplatin may damage the inside layer of blood vessels called the endothelium. The~     purpose of this study is to measure changes in the endothelium that happen when patients with~     GCT get cisplatin chemotherapy and to compare these changes with a group of patients not~     receiving chemotherapy.~   "
161382|NCT01453647|"~     This project will be the first known to explore the relationships among immunity and stress~     and the symptoms of fatigue, pain, and mood following guided imagery in women with~     fibromyalgia. Finding ways to reduce these unpleasant symptoms may lead to improved function~     and well-being in this chronic disorder.~   "
161383|NCT01453634|"~     Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol~     Injection.~   "
161384|NCT01453621|"~     Blunt head trauma (BHT) accounts for >450,000 emergency department (ED) visits for children~     annually in the US. Fortunately, >95% of head trauma in children is minor in nature. Although~     most children have minor head trauma, clinicians obtain cranial CTs in 35-50% of these~     children, which carries a radiation risk of malignancy. Recently, the investigators conducted~     a study of 44,000 children in the Pediatric Emergency Care Applied Research Network (PECARN)~     in which the investigators developed and validated clinical prediction rules that identify~     which children with minor BHT are at very low risk of having clinically-important traumatic~     brain injuries (TBI) and, therefore, do not require a CT scan. In this proposal, the~     investigators aim to assess whether implementing the PECARN TBI prediction rules (one for~     preverbal, one for verbal children) via computerized clinical decision support (CDS)~     decreases the number of (unnecessary) cranial CT scans obtained by ED physicians for children~     with minor BHT at very low risk of clinically-important TBIs. After a two-site pilot phase to~     test and refine the CDS, the investigators will conduct a seven-center prospective trial. The~     investigators will measure cranial CT use prior to and after the intervention implementation~     of CDS and clinician education. The investigators will study the use of CT by practitioners~     for children <18 years for 12 months pre- and post-intervention.~   "
161385|NCT01453608|"~     The purpose of this study is to determine, relative to placebo, the effect of iron repletion~     therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with~     chronic heart failure and iron deficiency.~   "
161386|NCT01453595|"~     This study tests a new medication for treatment of kidney cancer, called BEZ235. This~     medication works by blocking several mechanisms that the cancer needs to grow and survive. By~     blocking these mechanisms, the medication can thus suppress further growth of the cancer,~     possibly kill cancer cells. Older kidney cancer medications (such as temsirolimus [Torisel®]~     or everolimus [Afinitor®]) typically only block one mechanism in cancer cells, so the~     investigators think that BEZ235 may work even better against kidney cancer.~      The purpose of the first part of this study is to test the safety of giving BEZ235 at~     different doses. The investigators are trying to find a safe dose of BEZ235 and want to find~     out what effects, good and/or bad, it has on the patient and the cancer.~   "
161390|NCT01453543|"~     Background: There is a hypothesis in literature that the mechanical action of deep transverse~     friction massage (DTF) produces vasodilatation and increases blood flow. But as yet, no~     experimental study has confirmed the effect of DTF on blood flow in the Achilles tendon.~     Objective: The purpose of the present study was to investigate whether one session of DTF can~     influence the Achilles tendon blood flow.~      Design: a randomized pre- posttest trial was set up. Patients: Sixty-two healthy participants~     volunteered. Each person underwent the following four steps of the procedure: 1. Measuring~     the tendon blood flow (PRE), 2.fifteen minutes of DTF on the Achilles tendon, 3. Measuring of~     the tendon blood flow (POST), 4.follow - up measurement after 20 minutes of rest (POST20).~      Intervention: one leg of each person was randomly assigned to deep transverse friction~     session, the other leg was used as a control leg. Friction was applied continuously for a~     total of 15 minutes. Measurements: the microcirculation was determined at 2 and 8 tissue~     depths at the distal and the proximal midportion of the Achilles tendon. For each level, the~     capillary blood flow, the tissue oxygen saturation, and the postcapillary venous filling~     pressure was registered.~   "
161391|NCT01453530|"~     Rationale: Recovery from outpatient anesthesia includes dissipation of anesthetics agents,~     normalization of physiological function, observation for medical or surgical complications,~     treatment of immediate side effects of anesthesia and surgery and, ultimately, discharge and~     return home. Street fitness implies that the patient is not only ready to go home, but is~     also capable of safely taking part in the traffic. A full recovery of cognitive functions is~     part of this stage. Neuromuscular blocking agents (NMBAs) are commonly used during surgery to~     facilitate endotracheal intubation, allow assisted or controlled ventilation, and let surgery~     proceed easily. Sugammadex is approved in Europe for routine clinical use to reverse~     neuromuscular blockade induced by steroidal non-depolarizing muscle relaxants. Several~     anesthesiologists from all over the world, have independently reported that patients seem to~     be more alert in the early phase of recovery after reversal of NMB with sugammadex compared~     to reversal with a cholinesterase inhibitor or spontaneous recovery. However, these~     observations have not been substantiated in a clinical study.~      Objective: The main aim of the present study is to assess whether sugammadex has a positive~     effect on the post-operative alertness of the patients, to assess the nature, magnitude and~     the time of onset of this effect and if a clinically relevant effect has been observed to~     enable the sample size calculation for a formal well-powered efficacy study.~      Study design: Randomized, controlled observer-blind single centre phase IV study. Upon After~     stratification for type of surgery and age patients will be randomized to receive sugammadex~     (arm A), neostigmine/glycopyrrolate (Arm B) or no reversal agent (arm C).~      Study population: A total of 30 evaluable subjects, aged 18-65 years, with a medical need for~     general anesthesia and neuromuscular blockade, will be included in the study.~      Intervention: Anesthesia will be standardized according to the usual protocol. At the end of~     the surgery when TOF ratio is ~0,9, and approximately 70-80% of nicotine receptors are still~     blocked by rocuronium, patients will receive either sugammadex, neostigmine plus~     glycopyrrolate, or no reversal agent.~      Main study parameters: At 30, 60, and 120 minutes after the TOF ratio of ~0,9 has been~     reached, the following commonly used, and non-invasive cognitive evaluations/scoring lists~     will be carried out in a subsequent order to assess recovery and psychomotor function:~     Modified Aldrete Score, the trail making test, the Maddox wing test, and visual analogue~     scales from both observer and patient.~   "
161392|NCT01453517|"~     The study is designed to test a pilot intervention for bariatric patients who are starting to~     regain weight after the 1st year post-surgery. Dialectical Behavior Therapy (DBT), an~     empirically supported therapy for Borderline Personality Disorder, has also successfully been~     applied to patients with substance use and binge eating problems. The purpose of this study~     is to develop and test a group intervention based on DBT and cognitive behavioral therapy~     (CBT) techniques for patients engaging in these maladaptive behaviors after surgery with~     co-occuring weight gain.~   "
161393|NCT01453504|"~     The purpose of this trial is~        1. to determine the recommended dose of everolimus for a subsequent Phase II trial~        2. to determine the efficacy of everolimus plus DHAP~   "
161394|NCT01453491|"~     The purpose of this research study is to:~        -  1) Test the safety and tolerability of 2 different oral doses of SRT2104 in subjects~          with ulcerative colitis~        -  2) Determine the amount of SRT2104 measured from a single blood sample in addition to~          colon and/or rectal tissue samples (biopsies)~        -  3) Determine whether SRT2104 has any anti-inflammatory effect on the colon and/or rectum~          when taken orally for 8 weeks~        -  4) Determine whether SRT2104 causes any detectable changes to specific biomarkers. A~          biomarker is a biological marker (or substance such as a protein) that is used as an~          indicator of changes in a biological state that corresponds to the risk or progression~          of a disease.~   "
161395|NCT01453478|"~     This is a Phase I study to assess the combined effects of food and suppression of gastric~     acid secretion on the relative bioavailability of an immediate release (IR) tablet~     formulation and prototype bioenhanced formulations of GSK1325756, an oral interleukin 8~     receptor (IL8R also known as CXCR2) antagonist. The objectives are to understand if the~     co-administration of food enhances absorption and the inter-subject variability for the~     current GSK1325756 IR tablet under fed state proton pump inhibitor (PPI) conditions and~     secondly to assess whether two proposed bioenhanced formulations offer any improvement over~     the current GSK1325756 IR formulation under PPI conditions.~      This open-label, randomized, 5-period crossover study will be completed in a single cohort of~     subjects, with an interim analysis after completion of Treatment Period 4. During Treatment~     Periods 1 to 4, subjects will be randomized to receive GSK1325756 50 mg IR in the fed state,~     GSK1325756 50 mg IR in the fasted state, GSK1325756 Bioenhanced Formulation 1 in the fasted~     state, and GSK1325756 Bioenhanced Formulation 2 in the fasted state. Progression to Treatment~     Period 5 and the choice of bioenhanced formulation for dosing in this treatment period will~     be dependent on the findings of an interim analysis of the pharmacokinetic profile and~     relative bioavailability of each formulation following completion of Treatment Periods 1 to~     4. In Treatment Period 5, subjects will receive the selected GSK1325756 bioenhanced~     formulation in the fed state.~   "
161396|NCT01453465|"~     RATIONALE: Studying biomarkers of tissue samples from patients with cancer in the laboratory~     may help doctors learn more about changes the occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with rhabdoid tumor~     of the kidney and atypical teratoid rhabdoid tumor.~   "
161397|NCT01453452|"~     RATIONALE: Physical activity, diet, and counseling may help breast and colorectal cancer~     survivors to lose weight and improve their quality of life.~      PURPOSE: This phase II trial studies how well exercise, diet, and counseling work in~     improving physical activity and weight loss in overweight women who are breast and colorectal~     cancer survivors.~   "
161424|NCT01453101|"~     The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and~     bortezomib improves the progression free survival and the response rate compared to~     historical controls of fludarabine and melphalan alone.~   "
161425|NCT01453088|"~     In this study the investigators are comparing this standard regimen to the newly established~     regimen of melphalan and bortezomib.~   "
161398|NCT01453439|"~     The purpose of this study is to learn more about two different types of psychotherapy to help~     individuals who have body dysmorphic disorder (BDD). BDD is a severe, often chronic, and~     common disorder consisting of distressing or impairing preoccupation with perceived defects~     in one's physical appearance. Individuals with BDD have very poor psychosocial functioning~     and high rates of hospitalization and suicidality. Because BDD differs in important ways from~     other disorders, psychotherapies for other disorders are not adequate for BDD. Despite BDD's~     severity, there is no adequately tested psychosocial treatment (psychotherapy) of any type~     for this disorder. This study will compare the effectiveness of Cognitive Behavioral Therapy~     and Supportive Psychotherapy as well as predictors of improvement.~   "
161399|NCT01453426|"~     This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of~     two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and~     Caucasian healthy volunteers.~   "
161400|NCT01453413|"~     The purpose of this study is to determine the difference between self-reported, estimated~     blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.~   "
161401|NCT01453400|"~     This study is to evaluate the onset of relief provided by a single, oral dose of fast release~     aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat~     pain.~   "
161402|NCT01453387|"~     The main purpose of this study is to test the experimental drug, MSC2015103B at different~     dose levels and on different treatment schedules, to see whether it is safe and can be~     tolerated when given to subjects once a day one day per week over a 21-day period or once a~     day three times per week over a 21-day period. The investigators would also like to find out~     how MSC2015103B is broken down by the body.~      Additional purposes of the trial are to assess side effects of MSC2015103B and to find out~     whether MSC2015103B has anti-cancer effects. In addition, the investigators would like to~     explore pharmacokinetics.~   "
161403|NCT01453374|"~     This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison~     and continuing VIVITROL upon release into the community.~   "
161404|NCT01453361|"~     Preliminary studies with a variety of vaccines suggest target accessibility (potential~     immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to~     overcome limitations of immunostimulatory cancer vaccines, the investigators have designed a~     novel autologous vaccine to address inability to fully identify cancer associated antigens,~     antigen recognition by the immune system (i.e. antigen to immunogen), effector potency, and~     cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer~     vaccines, the investigators designed a novel dual-modulatory autologous whole cell vaccine,~     Vigil™ (bi-shRNA furin and GMCSF Autologous Tumor Cell Vaccine), incorporating the rhGMCSF~     (recombinant human GMCSF) transgene and the bifunctional shRNAfurin (to block proprotein~     conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer~     associated antigens, 2) effect antigen recognition by the immune system (i.e. antigen to~     immunogen), 3) enhance effector potency, and 4) subvert endogenous cancer-induced immune~     resistance. The investigators have also completed the Phase I assessment of Vigil™ vaccine in~     27 advanced solid tumor patients (1.0 x 10e7 or 2.5 x 10e7 cells/injection/month for a~     maximum of 12 vaccinations) who have not experienced any significant adverse effects~     following 131 vaccinations, including 4 patients with melanoma. Plasmid functionality, immune~     biomarker response, and preliminary evidence of anticancer activity have been observed. This~     is a Phase II study of intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7~     cells/injection; maximum of 12 vaccinations) in patients with stages IIIc and IV melanoma~     with biopsy accessible lesions to document blood and intratumoral immune responses and assess~     correlation with survival.~   "
161405|NCT01453348|"~     This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine~     given alone or concomitantly with MenACWY-CRM to healthy adults.~   "
161406|NCT01453335|"~     VeinViewer® Vision will significantly increase the number of peripheral intravenous catheter~     access targets perceived by clinicians with experience in intravenous cannulation when~     compared to the number of access targets that these clinicians are able to visualize unaided~     or to palpate.~   "
161407|NCT01453322|"~     The objective of this study is to confirm and document that with the use of a FDA Class I~     exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for~     healthy adult volunteers with varying skin types to assist in the improved visualization, it~     is possible to film, analyze and document PIV localized complications and venous flow and~     refill.~   "
161408|NCT01453309|"~     The purpose of this study is to determine the cost-effectiveness of using a cell saver for 2~     to 3 level lumbar fusions. A secondary objective is to determine if there will be a decrease~     in the number of allogenic blood transfusions when a cell saver is used intraoperatively.~     Another secondary objective is to determine incidence of complications associated with cell~     saver use and transfusions.~   "
161409|NCT01453296|"~     This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444,~     an orally inhaled long-acting agonist of the β2-adrenoceptor.~   "
161410|NCT01453283|"~     Background:~        -  Trabectedin is an experimental drug that kills some cancer cells in the laboratory and~          in mice by interfering with genetic material (DNA) in cancer cells.~        -  In some adult patients with cancer who received trabectedin, tumors grew slower or~          shrank.~      Objectives:~        -  To determine a dose of trabectedin that can be given safely to children and adolescents~          as a 24-hour continuous infusion through a vein.~        -  To determine the side effects of trabectedin in children and adolescents.~        -  To study how the body handles trabectedin by measuring the amount of the drug in the~          bloodstream over time after a dose is given.~        -  To measure the effect of trabectedin on DNA in white blood cells.~        -  To determine if an individual's tumor cells have a specific proteins involved in DNA~          repair and if a pattern of genes can be identified in tumor samples that might help~          explain why trabectedin reduces tumors in some individuals and not others.~        -  To study genetic factors that may influence the way the body handles trabectedin.~        -  To see if trabectedin is beneficial in certain types of cancer.~      Eligibility:~      -Children between 4 year and 17 years of age with tumors that recur or no longer respond to~     standard treatment.~      Design:~        -  Patients receive trabectedin as a 24-hour continuous infusion repeated every 21 days.~          The first three children entering the study receive a dose of 1.1 mg/m2. Subsequent~          groups of up to six patients receive higher doses (1.5 mg/m2 and 1.7 mg/m2) as long as~          the preceding dose is well tolerated. Patients enrolled at the lowest dose level may~          have their dose increased to the next level if they tolerated the lower dose well.~          Treatment may continue as long as the cancer does not worsen and the treatment is~          tolerated.~        -  Patients have blood drawn on days 1, 2, 3, 4, 5 and 7 of the first treatment cycle to~          study how the body handles trabectedin.~        -  A tumor sample obtained from a prior surgery or biopsy is examined for proteins involved~          in DNA repair.~        -  A blood sample is drawn to look for genetic factors that may influence how the body~          handles trabectedin.~        -  Patients have periodic physical examinations and blood tests. MRI or CT scans are done~          before starting therapy and after every two treatment cycles to evaluate the tumor.~   "
161412|NCT01453257|"~     Treatment options for patients with colorectal cancer (CRC) have increased in the last years.~     However, there are no validated prospective molecular markers in CRC to select which agents~     are better to treat any individual case. The conventional first-line treatment in CRC~     patients in clinical studies get a proportion of patients free of progression at 12 months~     ranging from 35-40% with a median of 9 months of free disease progression.~      The aim of this study is to demonstrate that the identification of therapeutic targets in~     real time and their prospectively use to customize the treatment get a proportion of~     colorectal metastatic patients patients free of progression disease at 12 months of 50%.~   "
161413|NCT01453244|"~     The aim of this study is to investigate the relationships between drug response and the host~     genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV).~     And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean~     patients with HCV.~   "
161414|NCT01453231|"~     Obesity is a chronic disease now considered a major public health concern in the global~     context, as it causes or exacerbates many diseases limitations in providing quality of life~     and higher treatment costs. The increase in the number of patients undergoing bariatric~     surgery and the excess skin and subcutaneous tissue adjacent to slimming collaborate in the~     search for growth by plastic surgery. Currently several techniques of thighplasty has been~     submitted but no studies were found that evaluated the characteristic clinical and emotional~     resulting from this procedure. This study has as a goal to evaluate the body image and~     quality of life in women submitted to thighplasty.~   "
161415|NCT01453218|"~     Renal dysfunction in the context of liver transplantation is a major issue, with difficult~     patients' management and determining a worsened prognosis.~      Physiopathologically pretransplant renal dysfunction is dependent on multifactorial causes,~     including hypoperfusion-derived functional renal insufficiency, hepatorenal syndrome or~     interstitial parenchymatous insufficiency. On top, intra- or post-transplant events,~     including hypoperfusion or calcineurin inhibitors nephrotoxicity may aggravate this~     situation.~      At present MELD criteria favours allocation of organs to patients suffering from renal~     insufficiency, so at least 30% of the investigators liver transplant patients suffer from~     some degree of renal impairment pretransplant.~      After liver transplant impaired renal function tends to recover partially or completely,~     unless advanced parenchymatous lesions are significantly involved as a major cause of renal~     dysfunction.~      In this context, calcineurin inhibitors avoiding or sparing protocols may help in the~     recovery from renal insufficiency, improving long-term prognosis. The use of anti-CD25~     antibodies is a good option, but provides a limited antirejection prophylaxis, limiting the~     use of these antibodies to a reduced cohort of liver transplant patients.~      Polyclonal antibodies might provide an advantage in management of liver transplant patients~     with renal insufficiency, without increasing acute rejection episodes of the allograft~     efficacy and security evaluation of low nephrotoxicity immunosuppression, based on the use of~     ATeGe, in liver transplant candidates with pre-transplant renal dysfunction.~      The aim of this study is to evaluate the efficacy and security use of immunosuppression based~     on ATeGe in liver transplant recipients with pre-transplant renal dysfunction.~   "
161416|NCT01453205|"~     The overall purpose of the study is to determine if MEDI-551, when used in combination with~     salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine~     (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem~     Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.~   "
161417|NCT01453192|"~     The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months~     after transplantation in HIV-infected patients under three antiretroviral drugs regimen~     including Raltegravir.~   "
161418|NCT01453179|"~     This clinical trial serves the purpose to compare the long-term effects of a treatment of~     actinic keratosis - your skin disorder - using Aldara® 5% cream (Imiquimod) or Solaraze® 3%~     gel (Diclofenac) on the face or the scalp. In particular, it should be found out whether the~     healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can~     be maintained for a prolonged period.~   "
161419|NCT01453166|"~     The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective~     diet plan to reduce cardiovascular risk factors of new cardiovascular events.~   "
161420|NCT01453153|"~     Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and~     tolerability study to determine the safe dose of PEGPH20 to use in combination with~     gemcitabine in Stage IV previously untreated pancreatic cancer patients.~      Phase 2: Randomized, double blind study to compare the effect of overall survival of~     gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated~     pancreatic cancer patients.~   "
161421|NCT01453140|"~     In this study the investigators are proposing to treat patients with steroid-refractory~     Graft-versus-host Disease (GVHD) in a manner designed to promote CD4+CD25+FoxP3+ Tregs. The~     profound immune suppression which follows the most common salvage treatment for GVHD have~     unfortunately lead to very poor outcomes because of high infection rates. A more targeted~     approach based on the promotion and stabilization of Tregs is hoped to allow GVHD control~     without the profound immunosuppression usually seen. High-dose cyclophosphamide and sirolimus~     have been successfully used for the prevention of GVHD and have shown to enhance the Tregs~     subpopulation. The addition of low dose IL-2 and a demethylating agent such as azacitidine~     will also be studied in an attempt to promote and stabilize the FoxP3 expression of Tregs.~   "
161422|NCT01453127|"~     The investigators propose using DaTscan in patients with REM sleep behavior disorder (RBD),~     mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB),~     Alzheimer's disease (AD), and other neurodegenerative syndromes and disorders, to test~     several hypotheses - some confirmatory, and some novel. Such use will provide new data on the~     potential clinical and research utility of DaTscan in neurodegenerative diseases. The~     findings on DaTscan will be correlated with clinical diagnoses and other multimodal imaging~     studies (e.g., MRI, MRS, FDG-PET, and amyloid-PET) to enhance our understanding of~     neurodegenerative diseases.~   "
161423|NCT01453114|"~     The overarching goal of this study is to adapt a cognitive behavioral prevention of~     recurrence treatment (CBT-PR) for women with a history of recurrent major depressive disorder~     who decide to discontinue their maintenance anti-depressant (AD) treatment for pregnancy.~   "
161426|NCT01453075|"~     The purpose of this study is to study the effects of valacyclovir on patients who have~     hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which~     causes genital herpes. Some persons with genital herpes have sores in their private areas but~     most persons do not have any symptoms at all. Valacyclovir is a medication which is commonly~     used to treat or prevent outbreaks of genital herpes. This medication is already approved by~     the Food and Drug Administration to treat genital herpes. Valacyclovir has not been approved~     to treat chronic hepatitis C.~      The study will take 16 weeks. Participants will be assigned to take either the study drug,~     valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and the~     persons participating will not know which medication they are receiving. Study visits will~     occur every two weeks and will take approximately 3-45 minutes. All study visits will occur~     at the G.V. Sonny Montgomery VA Medical Center.~   "
161427|NCT01453062|"~     B-cell chronic lymphocytic leukemia (CLL) is a subtype of mature peripheral B-cell neoplasms,~     characterized by the accumulation of circulating malignant lymphocytes that typically express~     cell surface markers CD5, CD20, and CD23. It is the most common type of leukemia in adults in~     Western Europe and in the US. The median age at diagnosis is 65-70 years, with a male to~     female ratio of 2:1. Initially, most patients present with asymptomatic lymphocytosis and do~     not need cytoreductive therapy. Patients with active disease are characterized by a~     lymphocyte doubling time of less than 6 months, or progressive, even massive lymphadenopathy,~     hepatosplenomegaly, anemia and thrombocytopenia. Constitutional symptoms such as fever, night~     sweats, unintended weight loss, and extreme fatigue are common in advanced disease and can~     significantly impact quality of life. CLL also causes relative immunosuppression that~     increases the risk of infections that are ultimately the major cause of death in this patient~     population. Median survival at diagnosis ranges from 5 to 20+ years depending on risk~     factors, but is only 6 to 14 months for patients with CLL refractory to available therapies.~      Arzerra (ofatumumab) is a human monoclonal antibody (IgG1) that binds specifically to a~     distinct epitope encompassing both the small and large extracellular loops of the CD20~     molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from~     the pre-B to mature B lymphocyte stage and on B-cell tumors.~      Arzerra is designated as an orphan medicinal product in the European Union (EU) for treatment~     of chronic lymphocytic leukemia. The Committee for Orphan Medicinal Products (COMP) concluded~     that chronic lymphocytic leukemia was estimated to be affecting approximately 3.5 in 10,000~     persons in the Community at the time the application was made (June 2008) and that the~     condition is chronically debilitating and life-threatening, in particular due to poor~     long-term survival in high-risk patients.~      Arzerra was given a conditional approval in the EU on April 19, 2010. The approved indication~     in the EU for the product is treatment of CLL in patients refractory to fludarabine and~     alemtuzumab. A specific obligation for this conditional approval was an agreement by GSK to~     conduct a post-marketing observational study in CLL patients receiving Arzerra. The data from~     this study is intended to enhance the evidence of the safety and efficacy of Arzerra as it is~     used in clinical practice, and once final data are available, together with results of a~     second specific obligation study, will support the transition from conditional to a full~     approval of Arzerra in the EU.~      The objective of this observational study is to provide additional data to confirm the safety~     profile and efficacy of Arzerra for CLL patients treated in clinical practice.~      Particular data of interest are: co-morbidities (specific chronic disease diagnoses),~     concomitant medications, disease (CLL) characteristics, prior treatment regimens, adverse~     events, reasons for discontinuation of Arzerra therapy, Arzerra response, progression free~     survival, and overall survival.~      This is an observational, non-interventional, medical record review study in CLL patients. A~     total of 100 patients with CLL who have previously received Arzerra, whether alive or~     deceased, and have either completed the full course of Arzerra therapy or discontinued~     treatment early will be eligible to participate in the study. Centers across Europe who are~     members and non members of the European Research Initiative of CLL (ERIC) and treat CLL~     patients will participate in the study.~      CLL patients newly initiating Arzerra who are still undergoing the treatment phase and~     patients having been treated with Arzerra in phase II or phase III clinical trials will be~     excluded.~      For patients who have completed approximately 1 year or more of follow up since Arzerra~     initiation, data on response to Arzerra, adverse events during treatment and subsequent to~     treatment, patient status, progression free survival and overall survival covering the period~     up to approximately one-year post-drug initiation will be collected. For patients who have~     not completed approximately l year of follow-up since Arzerra initiation, including those who~     have been lost to follow up or died prior to one year or have not yet had a full year to~     elapse in calendar time, similar data will be collected at the point in time at the last~     available patient contact with the physician using information in the record. After approach~     for informed consent from the patient or next of kin for patients who have died to review the~     medical record, no interaction with the patient will occur.~   "
161428|NCT01453049|"~     The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose~     combination tablet will safely and effectively control glycemia as first-line oral therapy in~     drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of~     treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary~     objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in~     lowering Glycosylated Hemoglobin (HbA1c).~   "
161429|NCT01453036|"~     1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin~          is one of the main causes of failure of eradication. 23S rRNA point mutation of~          Helicobacter pylori is associated clarithromycin resistance~        2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment~          regimens containing a proton pump inhibitor and combination of two antibiotics~          (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate~          Helicoabacter pylori more successfully~        3. Material & methods The investigators enroll patients diagnosed with peptic ulcer,~          endoscopically. Helicobacter pylori is documented with Urea breath test or silver~          staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S~          rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation,~          the investigators consider as resistance to clarithromycin and choose the treatment~          regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no~          mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin,~          clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare~          eradication rate with conventional treatment,proton pump inhibitor, amoxicillin,~          clarithromycin.~   "
161430|NCT01453023|"~     This study will investigate the safety and tolerability, pharmacokinetics, and~     pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the~     novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.~   "
161431|NCT01453010|"~     Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors~     and causes huge loss of function and independence. A wide range of treatment approaches have~     been developed to improve motor recovery. Despite treatments, such as Constraint Induced~     Movement Therapy, showing promise, these in large have been have focused on high-intensity~     and repetitive task-specific practice. Patients with little hand or finger movements however~     may not be able to participate actively in task specific training.~      The SaeboFlex is a dynamic orthosis, with a spring-loaded feature that facilitates opening of~     the fingers and hand. This allows the patient to grasp and release objects repeatedly, hence~     enabling participation in repetitive task practice and increasing potential for motor~     recovery. Despite the SaeboFlex being used successfully in several centers in the country and~     internationally, research to provide evidence of effectiveness is scarce. As a consequence~     funding for the SaeboFlex is limited and usually requires patients' to fund their own.~      The study aims to explore the potential benefits and feasibility of participating in a~     Self-directed SaeboFlex training program to allow repetitive task practice in patients early~     after stroke.~      Subjects will undergo a 12-week training program comprising of a maximum of 3 x 45 minute~     sessions a day. Activities focus on grasping and releasing balls and reaching for targets,~     wearing the SaeboFlex for the majority of the session. At the end of each session the~     SaeboFlex is removed and the hand is incorporated into functional tasks as able. Subjects~     will be set individualized training program by a Saebo-trained therapist. The program will be~     graded and progressed at a rate that is appropriate to each individual.~      The study will measure and follow-up 8 subjects to explore improvements in recovery and~     functional ability of the upper limb and affect on dependency levels. It will also explore~     the level of intensity patients early after stroke can tolerate and how they participate in~     self-directed therapy. All patients will meet the inclusion criteria and be motivated to~     undergo the specific SaeboFlex self-directed training program. Subjects will record the time~     and intensity of their training sessions and also their routine upper limb therapy. Patients~     will be assessed before, during and after the 3 months training. If these cases show promise~     the study will support the need for large trials including clinical efficacy and dose finding~     studies.~   "
161432|NCT01452997|"~     The purpose of this study is to evaluate two separate antiinflammatory products for the~     relief of symptoms through suppression of the immunological and inflammatory response~     following a mosquito bite. The investigators have selected ibuprofen gel as a NSAI~     formulation and 0.05% Clobetasone butyrate as a steroid cream with their appropriate physical~     matched placebo products.~   "
161433|NCT01452984|"~     Mohs surgery excises non-melanoma skin cancer tumors of the head and neck while preserving~     maximum healthy tissue, an advantageous characteristic when dealing with the cosmetic and~     functional cervifacial region. Yet, treatment can result in changes to function and~     appearance with effects on quality of life. This project uses Grounded Theory to explore the~     Mohs surgery experience of NMSC patients who have head and neck lesions through interview and~     observation of the surgical appointment.~   "
161434|NCT01452971|"~     Environmental carcinogens such as polycyclic aromatic hydrocarbons (PAHs) were reviewed as~     the major risk factors for lung cancer development. In this proposal, the investigators~     collected fifteen kinds of major PAHs and the investigators would like to perform the~     following studies:~        1. Study the gene expression and subcellular localization of GNMT in the normal-tumor~          tissue pairs of lung cancer patients.~        2. Study the associations of the polymorphisms of GNMT in lung cancer patients and the~          susceptibility to lung cancer;~        3. To assess the allelic loss at GNMT and determined the LOH rate of GNMT in the~          normal-tumor tissue pairs of lung cancer patients.~        4. Study the associations of the copy number variation (CNV) of GNMT and the susceptibility~          to lung cancer;~        5. Study the interaction between GNMT and polycyclic aromatic hydrocarbons (PAHs) in lung~          cancer cell lines.~   "
161501|NCT01452100|"~     Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring~     in elderly with severe atherosclerosis.~      In most patients, avoiding the precipitating factors and combination of statin and RAS~     inhibitor are recommended.~      The lack of randomized controlled trial in CCE precludes significant advances. The~     investigators decided to assess whether prednisone started early, at mild dosage and for a~     short period prevents death and progression to end-stage renal failure in patients with~     severe CCE, as compared to placebo.~   "
161435|NCT01452958|"~     Main objective :~      The purpose of this study is to prove that the effects of bacterial endotoxin and cytokine~     TNF-α, on protein loss, fatty acid release, and glucose metabolism depend on two mechanisms:~        1. Direct local effects in muscle tissue.~        2. Activation of the hypothalamo-pituitary axis and a stress-hormone response~      Study protocols:~        1. Acute metabolic effects of TNF-α(Beromun, Boehringer-Ingelheim Germany) vs placebo~          perfused into the femoral artery of the leg in 8 healthy subjects.~        2. Acute metabolic effects of~             -  placebo(saline)~             -  endotoxin(US standard reference E.Coli, endotoxin)~             -  TNF-α(Beromun, Boehringer-Ingelheim Germany) given systemically~             -  in 8 patients with hypopituitarism(to block stress hormone release) and in 8~               healthy subjects all studied thrice.~   "
161436|NCT01452945|"~     Young children presenting to the Emergency Department (ED) with wheezing often have prolonged~     stays in the ED or even get admitted to the hospital. This is a prospective observational~     study in which the investigators will use bedside 2D ultrasound to evaluate the lung~     ultrasound findings in children less than 24 months presenting to the ED with wheezing.~      The investigators hypothesize that children less than 24 months presenting to the Emergency~     Department with wheezing will have a range of lung ultrasound findings that will include~     normal findings, B lines, subpleural consolidations, and pleural effusions. The investigators~     also hypothesize that the findings will be reproducible between two equally trained~     providers.~      The investigators also hypothesize that lung ultrasound findings patients 0-24 months~     presenting to the ED with wheezing will correlate with specific clinical outcomes. An~     exploratory analysis will be performed to look for correlations between lung US findings and~     acute severity, final diagnosis, presenting symptoms, prematurity, risk factors for atopy,~     response to treatment and radiologic or viral studies if performed.~   "
161437|NCT01452932|"~     Objective: To estimate the effectiveness of muscle training, the degree of dyspnea and~     aerobic capacity in patients over 50 with COPD, in a health care institution provider in~     Antioquia.~      Question: What is the effectiveness of muscle training, in the degree of dyspnea and aerobic~     capacity in COPD patients over 50 years, in a health service institution provider in the~     department of Antioquia?~      Hypothesis: Muscle training causes changes in the degree of dyspnea and aerobic capacity,~     other than the breathing exercises and relaxation~      Design: Randomized clinical trial with allocation and blinding of the autcomes assesor.~      Participants: COPD patients stage II and II, male and female, over 50 years old, who are~     attending to a community health service provider in the department of Antioquia.~      Intervention: A physiotherapeutic intervention using PNF technique was applied to the~     experimental physiotherapy group versus Yoga sessions applied to the other group. Twelve~     weeks protocol performing three sessions per week.~      Outcome measures: Dyspnea degree and aerobic capacity was measured using the MMRC scale and~     the six minute walking test respectively at the begining and the end of the study.~   "
161438|NCT01452919|"~     The purpose of this study is to determine whether or not people with schizophrenia who take~     LY2140023 become physically dependent on it, and experience a series of symptoms such as~     craving to have the drug when they stop using it.~      This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a~     double-blind phase consisting of up to 3 weeks.~   "
161439|NCT01452906|"~     The purpose of this study is to determine if Omeprazole is affected by PA21.~   "
161440|NCT01452893|"~     Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore,~     patients who suffer from both, adrenal insufficiency and type I diabetes more frequently~     report hypoglycemia, particularly after strenuous activities. The study investigates the~     counter regulatory hormonal response to physical stress and the impact on cognitive function~     in subjects with and without Addison's disease, type I diabetes and healthy subjects.~   "
161441|NCT01452880|"~     The purpose of this study is to compare the analgesic efficacy and side effects induced by~     administration of two different infusion rates of remifentanil, 0,05 mcg/ Kg/ min versus~     0,1mcg/ Kg/ min, in order to determine which one is the most appropriate analgesic treatment~     to face extracorporeal shock wave lithotripsy.~   "
161442|NCT01452867|"~     Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and~     maintaining an upper airway patent. Gaining evidence which ventilation technique may be most~     efficient and safe is of utmost importance to potentially improve outcome during~     cardiopulmonary resuscitation.~   "
161443|NCT01452854|"~     The purpose of this study is to look at how a chemotherapy treatment (Temozolomide, also~     called Temodar) affects the process of ovarian aging which is measured by a decline in~     ovarian follicle count, in patients with Low Grade Glioma (LGG). It is important to know if~     different patient factors and Temozolomide influence the rate of ovarian aging in women with~     LGG who have good long-term survival rates. This will allow better counseling about the~     effects of this particular chemotherapy agent on fertility in women.~   "
161444|NCT01452841|"~     Folklore has suggested that consuming grapefruit may promote weight control. Sparse data~     exist to support this hypothesis, though there is some evidence of health promotional effects~     regarding blood pressure and lipid profiles. The aims of this randomized controlled trial are~     to determine the role of grapefruit in:~        1. Reducing weight~        2. Reducing blood pressure~        3. Reducing inflammation~        4. Improving the lipid profile.~      The investigators hypothesize that six weeks of daily consumption of grapefruit will reduce~     weight, blood pressure, and inflammation while improving the lipid profile in overweight,~     healthy adults.~   "
161445|NCT01452828|"~     The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of~     TR701 FA in subjects with advance renal impairment.~   "
161446|NCT01452815|"~     The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg~     and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains~     no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms~     associated with gastroparesis.~   "
161447|NCT01452802|"~     The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II~     (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class~     IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who~     meet the FDA approved indications for HM II LVAD destination therapy.~   "
161448|NCT01452789|"~     The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after~     utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was~     associated with a ~30% reduction length of treatment compared to standard of care morphine.~     Due to the subjective nature of the scoring instrument, efficacy in a blinded trial is needed~     to unequivocally establish the superiority of buprenorphine over morphine. The primary~     objective of the trial is to compare length of treatment using sublingual buprenorphine or~     oral morphine solution in the pharmacologic treatment of the NAS.~   "
161449|NCT01452776|"~     The purpose of this study is to determine the safety of long term use of TAK-438, once daily~     (QD), for the maintenance treatment of healed erosive esophagitis.~   "
161450|NCT01452763|"~     The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared to~     AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require~     long-term therapy of low-dose aspirin.~   "
161451|NCT01452750|"~     The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared~     to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require~     long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).~   "
161452|NCT01452737|"~     The investigators wish to compare the efficacy and patient tolerability of a preparation~     consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard~     preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg~     bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.~   "
161453|NCT01452724|"~     The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared~     to lansoprazole in patients with duodenal ulcer.~   "
161454|NCT01452711|"~     The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD),~     compared to lansoprazole in patients with gastric ulcer.~   "
161455|NCT01452698|"~     The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared~     to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA~     classification grading system.~   "
161456|NCT01452685|"~     The purpose of this study is to compare the long term safety and efficacy of TAK-385, once~     daily (QD) following continued administration in participants who completed a Phase II~     dose-finding study.~   "
161457|NCT01452672|"~     This study compares two different field set-ups in patients with breast cancer following a~     breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the~     chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa.~      Patients in both treatment arms will receive radiotherapy with a shortened fractionation~     schedule.~      Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the~     chest-wall and supraclavicular fossa in terms of loco-regional control, survival and~     treatment toxicity.~   "
161458|NCT01452659|"~     The purpose of this study is to determine the efficacy and safety of TAK-385, once daily~     (QD), for 12 weeks in women with uterine fibroids.~   "
161459|NCT01452646|"~     The purpose of this study is to determine whether a risk-adapted, minimal-residual-disease~     directed therapy for young adults with newly diagnosed acute myeloid leukemia has positive~     results in terms of overall survival at 24 months.~   "
161460|NCT01452633|"~     This study will help to answer the question, Does injecting local anesthetic before~     laparoscopic instrument ports are placed decrease pain after surgery? Patients participating~     will be randomly assigned to receive local anesthetic or saline injection at the site of a~     laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24~     hours the patient will be asked to rate their pain on a simple chart.~   "
161461|NCT01452620|"~     Registry for Endovascular repair of abdominal aortic aneurysm performed primarily by~     Interventional Cardiologists~   "
161462|NCT01452607|"~     A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in~     healthy adults.~   "
161463|NCT01452594|"~     The drug diphenylcyclopropenone, or DPCP, modifies the immune system and has been shown to be~     effective in treating certain kinds of cancer. This study hopes to improve our understanding~     of how this drug helps create an effective immune response.~   "
161464|NCT01452581|"~     The purpose of this study is to evaluate the effects of transfusion of red blood cells in~     treating postoperative dizziness in patients with moderate postoperative anemia after total~     hip arthroplasty.~   "
161465|NCT01452568|"~     The optimal medical strategy for prevention of thromboembolic events after bioprosthetic~     aorta valve replacement (BAVR) remains controversial.~      The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against~     aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or~     without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate~     thromboembolic complications, bleeding complications and death.~   "
161466|NCT01452555|"~     The purpose of the study is to determine if a Spanish-language HIV and HIV test information~     video is as effective in delivering basic information regarding HIV and HIV tests to~     primarily Spanish-speaking HIV test recipients as an in-person presentation with an HIV test~     counselor.~   "
161467|NCT01452542|"~     The primary objective of this pilot study is to determine the within-subject pharmacokinetic~     (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat~     administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed~     commercial formulation (1x150-mg capsule) in healthy adult subjects, which will be used to~     plan and support the design of a subsequent bioequivalence study.~   "
161468|NCT01452529|"~     The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD~     tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe~     chronic low back pain uncontrolled by their current stable analgesic regimen~   "
161502|NCT01452087|"~     Compare the effects of single session of exercise vs. chronic exercise training on key risk~     factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and~     blood pressure) in overweight adults.~   "
161539|NCT01451606|"~     This study is examining the effectiveness of duloxetine as a treatment for chronic pelvic~     pain in women. Duloxetine is FDA approved for the treatment of other pain conditions,~     including fibromyalgia and diabetic neuropathy.~   "
161469|NCT01452516|"~     Spine fusion is one of the most common procedures performed in spinal surgery. Several~     surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion~     (PLF) is the most widely used. However, complications can develop when the bone graft~     material used is insufficient to achieve the desired fusion. With its unique properties,~     nanOss Bioactive can be mixed with bone marrow aspirate (BMA) and other graft materials to~     obtain new bone growth during the healing process.~      It is hypothesized that the use of nanOss Bioactive will result in fusion at 12 months, with~     CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than~     5 degrees of angular motion. In addition, patients are expected to see an improvement in~     Oswestry Disability Index scores, VAS pain scores, and SF36 scores, while decreasing the use~     of pain medication, returning to work, and finding satisfaction in the results of their~     surgery.~   "
161470|NCT01452503|"~     Evaluation of preference for three female condoms (FC).~   "
161471|NCT01452490|"~     The purpose of this study is to evaluate the V-Raser diode laser system with investigational~     Nail Fungus Handpiece in the treatment of onychomycosis.~   "
161472|NCT01452477|"~     Tanshinone was originally isolated from dried roots of Salvia miltiorrhiza bunge. In Chinese~     medicine, this herb has been widely prescribed for several pathologies, including diabetes,~     acne, cardiovascular disease.It has been demonstrated that the therapeutic benefit of~     cryptotanshinone on prenatally androgenized rats may be mediated by its dual regulation of~     key molecules during both insulin signaling and androgen synthesis.The purpose of this study~     is to determine whether tanshinone may prove effective in eradicating Polycystic Ovary~     Syndrome (PCOS) symptomatology.~   "
161473|NCT01452464|"~     The purpose of this US FDA post-marketing commitment study is to evaluate the safety of~     MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance~     Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The~     pre-specified 26 events of interest are events commonly evaluated in vaccine safety studies~     and include certain neurological, immunological, vascular, musculoskeletal and hematologic~     disorders. All events are collected retrospectively.~   "
161474|NCT01452451|"~     The purpose of this study is to investigate the safety and tolerability of repeated doses of~     HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on~     stable metformin monotherapy.~   "
161475|NCT01452438|"~     The purpose of this study is to summarize the occurrence of incident serious medically~     attended events and events of interest up to 1 year following MenACWY-CRM vaccination~     administered as part of routine clinical care. This US FDA post-marketing commitment study is~     an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine~     in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The~     26 events of interest are events commonly evaluated in vaccine safety studies and include~     certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All~     events are collected retrospectively.~   "
161476|NCT01452425|"~     Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular~     compartment pressures, and is a rare but serious postoperative complication.~      The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and~     non-invasively.~      The objective is to develop a model mimicking the physiopathology of MCS to assess the~     interest of the INVOS in this case.~   "
161477|NCT01452412|"~     Kidney disease is a common medical condition. Individuals with kidney disease develop a~     build-up of acid in their blood. This acid can affect their muscles, bones, glucose~     metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up,~     in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones,~     glucose metabolism and kidney.~   "
161478|NCT01452399|"~     This research study is designed to look at whether the routine use of shave margins (by~     taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of~     having positive surgical margins requiring another surgical procedure, and whether this~     affects the long-term chances of getting cancer back in your breast.~   "
161479|NCT01452386|"~     To prove the modify functional magnetic stimulation could improve constipation.~   "
161480|NCT01452373|"~     The purpose of this Phase III trial is to evaluate the efficacy of oral administration of~     dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor~     modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.~   "
161481|NCT01452360|"~     This project expects the integrated database of terminally renal ill patients combines~     clinical and files of Health Insurance and renal medical society database. It will provide~     valuable actual evidence data to quality monitoring of dialysis treatment and related~     academic research. Besides, using the cohort study of chronic renal disease --「epidemiologic~     research of chronic renal disease」, we can trace the patient continually and analysis~     different risk factors of chronic renal disease in Taiwan. Taken together, the results of~     this project --1.1「Integrate the current database of renal disease and establishment of~     national monitor system」and 1.2「Epidemiologic study in chronic renal disease」-- will provide~     the basic rules of prevention and treatment, basic research and clinic application in chronic~     renal disease.~   "
161482|NCT01452347|"~     To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical~     heart valve.~   "
161483|NCT01452334|"~     The purpose of this study is to determine the side effects of treatment with the monoclonal~     antibody anti-PD-L1 (BMS-936559) in subjects with compromised bone marrow function and the~     dose that should be recommended for use in future studies.~   "
161484|NCT01452321|"~     Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a~     strategic aid in the treatment of postpartum depression.~      However, up to current days there have been no studies evaluating the effects of rTMS on~     neurocognitive and social performance of women suffering from the disorder.~      The present study evaluates the impacts of rTMS in clinical, cognitive and social~     performance.~   "
161520|NCT01451853|"~     Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is~     the objective of this study to determine the safety and efficacy of SPI-1005 at three dose~     levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum~     chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat~     chemotherapy induced hearing loss and tinnitus.~   "
161485|NCT01452308|"~     This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with~     fibrosis of the liver.~      Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of~     10 participants who will receive simtuzumab every other week for a total of 3 infusions.~     Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a~     total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen~     in Cohort 1.~      Participants from both cohorts who have completed the main study will be allowed to continue~     on simtuzumab treatment for an additional extension period, and will receive up to 13~     additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.~   "
161486|NCT01452295|"~     VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five~     years after their completion of study participation in protocol VTI-206 (NCT00973817) to~     gather information relating to the incidence of liver transplant, the incidence and type of~     cancer (if any), and survival.~   "
161487|NCT01452282|"~     Introduction: Patients undergoing noncardiac surgery are at increased risk of cardiovascular~     complications. The development of methods that can accurately predict the occurrence of these~     events is of critical importance and large studies have been published with this purpose.~     Based on these studies, several algorithms have been proposed to predict of cardiovascular~     events postoperatively. However, quantification of this risk is often difficult to measure,~     especially in those patients with subclinical disease, not always detected in routine~     evaluation. The ankle brachial index (ABI) has proved a valuable tool in the quantification~     of cardiovascular risk, and perhaps the most promising when compared with other methods. It~     is easy, cheap, fast and feasible in office care, with a great acceptance between patients~     and small intra and inter observer variability. Despite strong evidence of the utility of ABI~     as a tool in assessing cardiovascular risk, there are no data about the use of ABI in other~     patients referred for non vascular surgery, which constitutes the majority of operations~     performed worldwide.~      Objectives: To evaluate the use of ABI as a predictor of cardiovascular events in patients~     undergoing non-cardiac and non-vascular surgery and its applicability as a tool in the~     reclassification of patient risk groups established by guidelines for perioperative~     evaluation.~      Methods: 300 moderate to high risk patients referred for non-vascular and non-cardiac will be~     included. Data about risk factors, signs and symptoms, physical examination and treatment~     used will be collected before surgery. The ABI will be measured and the patient will be~     monitored for 30 days to the detection of cardiovascular events: death from any~     cardiovascular causes, unstable angina, nonfatal myocardial infarction, isolated elevation of~     troponin, decompensated heart failure, cardiogenic shock, stop nonfatal heart failure,~     pulmonary edema, stroke and lower limb ischemia. Postoperative electrocardiogram, total~     creatine kinase, MB fraction and troponin I will be measured daily until 3º day and whenever~     clinically indicated.~   "
161488|NCT01452269|"~     The purpose of the Deaf Weight Wise study is to test a 16 week, evidence-based, comprehensive~     program to change obesity-related health behaviors in Deaf people who use American Sign~     Language (ASL) as their primary language.~      Participants will be randomized to one of two study arms - immediate intervention or delayed~     intervention. In addition to the intervention activities, participants will also take part in~     five study visits over the course of two years. At these study visits, the investigators will~     administer several surveys as well as conduct biometric assessments.~      The investigators primary hypothesis is that the immediate intervention group will increase~     their levels of physical activity and reduce their caloric intake and body weight immediately~     following the intervention, compared to the delayed intervention group.~   "
161489|NCT01452256|"~     Desflurane and its effect on postoperative morbidity and mortality in patients undergoing~     thoracic surgery.~      Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a~     group of general anesthetics. Because of the hypnotic effects of these agents, attention has~     mainly focused on the central nervous system. In the last 10 years, however, numerous studies~     have reported that volatile anesthetic agents interact with membrane structures of the~     myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural~     abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced~     preconditioning has become a main topic in cardiac research worldwide~        -  Trial with medicinal product~   "
161490|NCT01452243|"~     The first objective is to determine the efficacy of calcium and vitamin D supplementation at~     doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in~     non-institutionalized elderly people.~      The second objective is to measure and compare treatment groups (calcium and vitamin D vs~     placebo) as regards muscle strength and musculoskeletal function, bone mineral density,~     calcidiol level and treatment safety.~   "
161491|NCT01452230|"~     Introduction: According to studies, a low physical capacity before surgery is linked with~     smaller weigh loss after surgery and increases risks of peri-surgical complications. Practice~     of regular physical activity in obese individuals improves their physical capacity. No~     specific recommendation on physical activity prescription is currently available for this~     reduced fitness population. This project aims to evaluate if a Pre-Surgical Physical Activity~     Training (PreSPAT) improves physical capacity, surgery effectiveness and decreases~     peri-surgical complications in morbidly obese individuals.~      Methods: This pilot project will be divided in 2 phases:~      Phase 1: Ten candidates for bariatric surgery will be included in this phase. In a~     pre-training focus group, subjects will be interviewed about their expectations and their~     availability for a PreSPAT. These results combined with those of the literature will be used~     to design the PreSPAT. To measure its effectiveness, anthropometric parameters, body~     composition, physical capacity, motivational stage, perceived benefits and barriers facing~     physical activity and quality of life will be evaluated before and after the PreSPAT.~     Subjects satisfaction with the physical activity intervention will be measured with a~     questionnaire at 6 weeks and at the end of the PreSPAT.~      Phase 2: 50 candidates for bariatric surgery will be randomized in 2 groups:~      Control group: receiving usual care from the integrated medical and surgical treatment~     obesity clinic of the Centre Hospitalier Universitaire de Sherbrooke, which includes~     individual counselling by an exercise physiologist every 6 weeks.~      Intervention group: will attend for three months before surgery sessions of supervised~     physical activity as developed during phase 1 in addition to usual care of the integrated~     medical and surgical treatment obesity clinic.~      Physical capacity, anthropometry, body composition, readiness to change, comorbidities,~     perceived benefits and barriers of physical activity, usual practice of physical activity,~     quality of life and patient satisfaction with physical activity intervention will be~     evaluated in the two groups before and after intervention and every 3 months after the~     surgery during one year. Each occurrence of peri-surgery complications, and the duration of~     surgery and hospitalization will be recorded.~      Impacts: Feasibility and effectiveness of supervised physical activity training will be~     assessed before the beginning of the randomized controlled study. Phase 2 of the project may~     generate information that will improve the management of obese candidates for bariatric~     surgery in order to ensure optimal results for their health. This project will also allow a~     better understanding of criteria leading to successful surgery and the effects of exercise~     training in morbidly obese individuals.~   "
161492|NCT01452217|"~     Alterations in pancreatic blood have been implicated in pancreatic inflammation and pain.~     Several modalities have been used to assess pancreatic blood flow although some of these~     methods are invasive, use ionising radiation or intravenous contrast media. This is the first~     study to utilise non-invasive magnetic resonance imaging to quantify flow within arteries~     supplying the pancreas and pancreatic perfusion is response to secretin stimulation.~   "
161521|NCT01451840|"~     This study is designed to compare the effects of alkalinized lidocaine in the endotracheal~     tube cuff to a bolus dose of remifentanil given prior to the emergence of anesthesia:~        -  on the incidence of perioperative coughing~        -  on the time needed for the emergence of a desflurane-based anesthesia~        -  on the incidence of sore throat after extubation.~      The investigators hypothesis is that the use of alkalinized lidocaine in the endotracheal~     tube cuff will reduce the incidence of perioperative coughing after a desflurane-based~     anesthesia.~   "
161493|NCT01452204|"~     In the past many authors have reported the abnormal contact between the rotator cuff and~     coracoacromial arch, but the exact etiology was not clearly understood. Thus, the objectives~     of this study relate specifically to improve the symptoms and rehabilitation of shoulder~     function of the patient:~        1. Assess the effectiveness of magnet therapy in the treatment of impingement of the~          rotator cuff;~        2. Assess whether the application of magnetic therapy 3 times a week for three weeks, may~          be effective as a single treatment of impingement of the rotator cuff;~        3. Assess whether the combination of magnetic therapy with therapeutic exercises is more~          effective than magnetic therapy only;~        4. Evaluate the benefits of magnetic therapy associated with therapeutic exercise in the~          short and long term.~        5. Assess the effectiveness of the modulation of pulsed electromagnetic field at 25 Hz and~          20 mT in patients with shoulder impingement syndrome.~   "
161494|NCT01452191|"~     Many children have accidents, some are very serious and they are a major cause of death in~     children aged 1-4 years. Many accidents are preventable This study aims to find out the best~     way to help Children's Centres to provide home safety information about preventing fires to~     parents and carers of young children.~      36 Children's Centres in four study centres, Nottingham, Bristol, Norwich and Newcastle will~     be recruited to the study. 30 families will be recruited from each Children's Centre.~     Children's Centres serving the most deprived populations will be eligible to take part.~      Families will be eligible to take part if they have attended a participating Children's~     Centre in the previous three months, have parents who are 16 years or older, have a child~     under three years old and live within the catchment area of that Children's Centre. When 30~     families have been recruited that Centre will be allocated, at random, to one of three~     groups. Children's Centres in group one will be provided with guidance about preventing~     fire-related injuries (an Injury Prevention Briefing (IPB))and help and support to implement~     the IPB, the second group will be sent the IPB and the third group will not be provided with~     the IPB ('usual care'). Children's Centres will devise their own programmes of safety advice~     for parents based on the IPB.~      At recruitment and 12 months later, families and Children's Centres will complete~     questionnaires about fire safety practices. Children's Centres will also complete a~     paper-based tool about the implementation process at 12 months. Information about barriers~     and facilitators to implementing the IPB will be collected through interviews with Children's~     Centre staff.~      The study will run from May 2011 to March 2014.~   "
161495|NCT01452178|"~     The main purposes of this study are:~        -  to describe the prevalence of peripheral artery disease (including lower extremity~          artery disease, carotid artery disease, renal artery disease, and abdominal aortic~          disease) in patients with acute myocardial infarction in comparison to control subject~          from the general population,~        -  to evaluate the association of peripheral artery disease with glucometabolic status in~          patients with acute myocardial infarction,~        -  to assess the prevalence of type D personality in patients with acute myocardial~          infarction com pared to control subjects from the general population,~        -  to examine the prognostic value of peripheral artery disease in patients with acute~          myocardial infartion, and~        -  to evaluate the prognostic value of type D personality in patients with acute myocardial~          infarction.~   "
161496|NCT01452165|"~     The main purposes of this study are:~        -  to describe the prevalence and degree of reduced left ventricular function and~          hypertrophy in patients with peripheral arterial disease in comparison to controls from~          the general population,~        -  to evaluate factors of importance to left ventricular dysfunction and hypertrophy in~          patients with peripheral arterial disease, and~        -  to assess the impact of cardiac function and left ventricular hypertrophy on long-term~          prognosis in patients with peripheral artery disease.~   "
161497|NCT01452152|"~     It is standard treatment to take anti-platelet medication after cardiac catheterization and~     stent placement to help prevent the formation of blood clots that may cause heart attack or~     stroke. The most commonly used anti-platelet medicine is clopidogrel (Plavix®). However,~     researchers have found that people vary in their response to clopidogrel, in part because of~     differences in their genes. Prasugrel (Effient®)is another anti-platelet medication used to~     prevent clots. The genetic differences that affect clopidogrel response do not affect~     prasugrel response. Recently, the FDA added a warning to the label of clopidogrel to notify~     doctors and patients with certain genetic differences may not get the full benefit from~     clopidogrel. Despite this, genetic testing for these variations is not usually done in~     standard medical practice. The purpose of this study is to see if patients with certain gene~     differences have fewer major cardiac events after stent placement if they are given~     anti-platelet therapy guided by their individual genetic type compared to standard~     anti-platelet therapy.~   "
161498|NCT01452139|"~     The objective of the RAPID STEMI study is to evaluate the feasibility, efficacy, and safety~     of a pharmacogenetic approach to anti-platelet therapy for the treatment of ST-segment~     elevation myocardial infarction (STEMI) patients following percutaneous coronary intervention~     (PCI) using point-of-care genetic testing for the CYP2C19*2, *17, and ABCB1 3435 C>T alleles.~   "
161499|NCT01452126|"~     This is a dose finding study to identify the minimum effective anesthetic concentration~     (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in~     supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and~     popliteal approaches to the sciatic nerve, femoral nerve and transversus abdominis plane~     (TAP) blocks in adults.~   "
161500|NCT01452113|"~     The purpose of this study is to compare the effect of a single administration of a DPP-IV~     inhibitor (vildagliptin: Galvus ®) versus no treatment over two populations of diabetic~     patients: without diabetic autonomic neuropathy (NA, i.e. the control group) and with~     diabetic autonomic neuropathy (i.e. the neuropathy group). The investigators hypothesize that~     the therapeutic efficacy of DPP-IV inhibitors is partly mediated by the autonomic nervous~     system. This hypothesis will be validated if a lower glycemic response to DPP-IV inhibitor~     treatment is observed for the neuropathy group compared to control.~   "
161522|NCT01451827|"~     The purpose of this study is to compare the short-term effects of two tolvaptan formulations~     in patients with ADPKD.~   "
161572|NCT01451177|"~     Evaluate the injections of Ji Gami(TM) and Ji Gami(TM) DO, where cells are expanded ex vivo~     from scalp, to induce hair growth in male and female subjects with hair loss.~   "
161573|NCT01451164|"~     To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients~     with schizophrenia.~   "
161503|NCT01452074|"~     the investigators first aim is to determine the effect of low intensity exercise (without~     weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these~     processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days~     without exercise in obese adults. the investigators second aim is to determine the effect of~     combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle~     lipid metabolism, and factors regulating these processes in skeletal muscle.~      Although a single 40 minute session of exercise at a low exercise intensity will not improve~     insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise~     training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied~     by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory~     activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid~     partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training~     program (without weight-loss) will be similar to that measured after 2 weeks of training. the~     investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and~     pro-inflammatory activation will be markedly improved after 10% weight loss when measured the~     day after exercise. the investigators would expect the improvements in Insulin sensitivity,~     accumulation of fatty acid intermediates, and markers of inflammatory stress will be~     significantly attenuated when measured 3 days after the most recent exercise session, but~     beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared~     with before weight loss.~   "
161504|NCT01452061|"~     There are three purposes to this study. The first purpose is to evaluate the value of a~     genetic test in determining risk for autism spectrum disorder. Processing for genetic samples~     will be completed at the Cleveland Clinic using research equipment provided by IntegraGen.~     The second purpose is to identify genetic changes that may be associated with autism spectrum~     disorder or attention deficit/hyperactivity disorder. The third purpose is to examine whether~     genetic differences and changes may predict which individuals benefit from medicine used to~     treat attention problems or other psychiatric difficulties.~      Between 600-800 people are expected to participate in this study - approximately 300~     individuals with an autism spectrum disorder, 75 individuals with attention~     deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy~     siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.~      Study procedures will vary based upon the specific group participants are suspected to fall~     into (autism, attention deficit/hyperactivity disorder, psychiatric concerns/developmental~     delay, healthy sibling, or unrelated healthy control).~        -  All individuals will be asked to participate in a cheek swab (gently swabbing the inside~          of your cheek) to obtain cells used for genetic testing. Genetic material will be stored~          with identifiers such as numbers, letters or codes.~        -  Parents or caregivers will be asked to complete questionnaires that examine medical and~          family history as well as current symptoms and quality of life for the participant.~        -  Participants may undergo speech and language testing. This involves answering questions,~          looking at pictures or identifying items.~        -  Information recorded in participant medical records will be reviewed and collected for~          this study.~   "
161505|NCT01452048|"~     The investigators specific aim is to compare the relationship between systemic fatty acid~     availability and insulin sensitivity in a relatively homogenous population of obese adults.~     The investigators anticipate 1) greater systemic fatty acid availability will be associated~     with lower insulin sensitivity and 2) greater systemic fatty acid availability will be~     associated with greater accumulation of fatty acid intermediates and pro-inflammatory~     markers.~   "
161506|NCT01452035|"~     Many of the beneficial metabolic effects of endurance exercise training are not due to~     adaptations to weeks, months, or even years of training, but rather much is due to the~     response to the most recent exercise session(s). Therefore, the investigators contend that~     lifestyle interventions for obese individuals should be tailored to optimize the metabolic~     effects of the most recent exercise session(s). But the dose of exercise necessary to evoke~     these beneficial responses is not known, and the mechanisms responsible for these~     improvements are poorly understood. The findings from these studies will: 1) establish the~     minimum dose of a single exercise session necessary to improve insulin sensitivity the next~     day in obese adults, 2) characterize the underlying metabolic factors responsible for the~     improvement in insulin sensitivity, and 3) assess the cumulative metabolic adaptations that~     occur over days, weeks, and months of a low-intensity/low-volume lifestyle exercise program.~     Findings from these studies will provide valuable information for the development of~     lifestyle programs aimed at maximizing the key metabolic health benefits of each exercise~     session in obese patients.~   "
161507|NCT01452022|"~     This is an open-label non-randomised, prospective, post market study to evaluate the~     performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving~     posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post~     operation using x-rays and CT scans. Quality of life questionnaires also used to assess~     clinical outcome measures such as pain and quality of life. Patients followed up for 24~     months after surgery.~   "
161508|NCT01452009|"~     A multi-center, observer-masked, randomized, parallel group efficacy and safety study of~     TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%~   "
161509|NCT01451996|"~     The primary goal of this study is to examine determinants of the efficacy of Claritin.~   "
161510|NCT01451983|"~     The purpose of this research is to better understand the genetic, biochemical, cognitive and~     behavioral symptom abnormalities that contribute to autism spectrum disorders. The~     investigators anticipate recruiting at least 100 participants with autism spectrum disorder~     and large head size, at least 100 participants with autism spectrum disorder without large~     head size and at least 40 healthy siblings. Biological parents are expected to be recruited~     only as genetic changes are identified in individuals with autism spectrum disorders to~     better understand the nature of these genetic changes. Participants are asked to complete~     cognitive testing, a blood draw, urine collection and measurement of his/her height, weight~     and head circumference. Parents or caregivers may be asked to complete a diagnostic~     evaluation and will complete questionnaires that examine the participant's medical and family~     history as well as his/her current symptoms, functioning, and quality of life. A brief report~     simply listing and giving a basic description of any behavioral diagnostic information,~     autism symptoms, adaptive functioning, and a listing of results from cognitive testing will~     be provided as part of this study.~   "
161535|NCT01451658|"~     Patients with hepatocellular carcinoma and esophageal varices bleeding were randomized to~     undergo endoscopic ligation alone (group A) and additive propranolol treatment (group B)~     after stabilization of their first acute bleeding.~   "
161536|NCT01451645|"~     The purpose of this study is to determine if once-daily treatment with colchicine, compared~     to placebo, is effective in preventing gout flares in patients who are initiating therapy~     with allopurinol.~   "
161511|NCT01451970|"~     Individuals have a significant capacity to adapt to different environments by changing their~     core metabolic pathways. This adaptation is especially important in regards to diet.~     Epidemiological research over the last several decades have shown that diets high in~     saturated fats have a greater ability to cause insulin resistance and the 'metabolic~     syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces the~     risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats, as~     compared to high carbohydrate or high saturated fat diets, result in increased insulin~     sensitivity and improved lipid profiles.~      In this application, the investigators propose to systematically assess the effects of two~     diets enriched in either saturated or unsaturated fatty acids and determine the cellular and~     molecular mechanisms of the apparent increase in insulin sensitivity. The investigators~     hypothesize that individuals will 'adapt' to the different diets and the investigators will~     be able to generate predictive alterations in gene expression and metabolites that underlie~     the alterations in metabolism. In parallel, the investigators will test the ability of these~     different diets to affect the release of gastrointestinal hormones that may be critical to~     modulation of appetite.~   "
161512|NCT01451957|"~     Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible~     for the improvements in metabolic health after a single session of endurance exercise. The~     investigators will determine the effect of a single session of endurance exercise on~     whole-body fatty acid mobilization and oxidation, IMTG concentration and the expression of~     factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity~     (age: 18-45y). In addition, the investigators will evaluate how these factors, and exercise,~     effect insulin signalling and insulin sensitivity. Every effort will be made to recruit~     subjects from ethnic and minority groups. Before participating in the study, subjects will be~     informed of all the procedures and potential risks, and they will sign an informed consent~     form approved by The University of Michigan Institutional Review Board. Eligible volunteers~     will participate in three separate trials, in a randomized order. In two trials subjects will~     eat exactly the same amount of calories, except in one trial they will exercise (eucaloric +~     exercise) and in the other trial they will remain sedentary (hypercaloric). In a third trial~     subjects will again remain sedentary but instead they will ingest appropriate calories to~     maintain caloric balance (eucaloric + sedentary). By doing this the investigators are also~     able to investigate the effect of acute caloric perturbations on insulin sensitivity, because~     it is possible that the enhanced insulin sensitivity evident after exercise, as compared to~     the sedentary state, is due to caloric deficit and not the exercise bout, per se.~   "
161513|NCT01451944|"~     The objective of our program is to evaluate the effect of home health nurse intervention and~     education on hospital admissions, ER utilization and asthma control of Passport asthma~     patients. The investigators hypothesize that case management and in home education by nurses~     will decrease hospitalizations and ER asthma visits and improves disease control in our~     population.~      Our clinic population consists of primarily inner-city, low income, medicaid recipients. This~     population suffers from severe asthma much more than the typical pediatric population. Asthma~     remains the most frequent cause of hospital admission for our patient population. Home health~     nurse asthma education and home visits have been reported to reduce asthma triggers in the~     home and improve asthma control. The unique partnership between the pediatrician and the home~     health nurse will give us a better understanding of the health needs for this population,~     will improve quality of care and deliver more cost effective care.~   "
161514|NCT01451931|"~     This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared~     to computed tomography (CT) for the initial emergency room evaluation of patients with~     suspected renal colic. The investigators will compare several measures of effectiveness~     including morbidity related to the patient's underlying disease, or complications related to~     delayed diagnosis, patient status regarding pain/missed days of work, and utilization of~     health care resources based on one of three study arms: ultrasound in the Emergency~     Department, ultrasound in Radiology or CT.~   "
161515|NCT01451918|"~     Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an~     over-the-counter health supplement, has been shown to have a number of health benefits. Data~     from in vitro and animal studies suggest that it has beneficial effects on insulin~     sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic~     studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein~     metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting~     the metabolic abnormalities of insulin resistant individuals the investigators plan to~     examine the effects of resveratrol on intestinal and hepatic lipoprotein production in~     humans.~   "
161516|NCT01451905|"~     To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans~     with no skin disease~   "
161517|NCT01451892|"~     Title:~      The effect of dance-therapy on the functional capacity, body image and quality of life of~     patients with advanced obesity~      Project duration:~      33 months (August 2010 to June 2013)~      Clinical context:~      Obesity has reached epidemic proportions. The gait and balance problems in obese people and~     the associated decreased functional capacity and risk of falling highlight the need to~     evaluate the benefits of specific treatments on these problems. Attention should be paid not~     only to metabolic management but also to the physical rehabilitation required in cases of~     advanced obesity.~      Objectives:~      The aim of this study is to evaluate the efficacy of dance-therapy on functional capacity~     (walking ability, postural control and physical activity level), body image and quality of~     life of patients with advanced obesity.~   "
161518|NCT01451879|"~     Hypothesis: the effectiveness of treatment of Pompe Disease with rhGAA enzyme replacement~     therapy (ERT) is limited at least in part because patients develop antibodies against the~     provided rhGAA enzyme. Treatment with immunomodulatory drugs may dampen or eliminate the~     anti-rhGAA immune response in patients receiving ERT, thereby allowing for greater ERT~     efficacy. Studying the immune response to rhGAA may provide valuable insight into the role of~     the immune system in the effectiveness of ERT for Pompe Disease.~   "
161519|NCT01451866|"~     A complex training on a dynamic leg-press with visual feed-back will improve coordinative~     capacity, power, sensorimotor and cognitive aspects more than a classic training on the same~     leg-press but without visual feed-back.~   "
161523|NCT01451814|"~     The primary objective of this study is to test a manualized adaptation of positive~     psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a~     preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and~     efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation~     treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will~     include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b~     research will provide the foundation for a future application to conduct a large-scale, Stage~     II, randomized clinical trial.~   "
161524|NCT01451801|"~     Previous studies have shown that 5-10% of Hepatitis B Virus vaccine recipients produce none~     or to few antibodies after a standard immunization with 3 vaccines. These individuals are~     defined as non-responders. The investigators wish to investigate if mounting another kind of~     immune response, called the cellular immune (CMI) response, protects these non-responders.~      Aim/Hypothesis~      Primary aims:~        1. To estimate the CMI response in serologic non-responders after receiving a standard~          course of HBV immunization~           Secondary aims:~        2. To establish the prevalence of serological non-responders after a standard course of HBV~          vaccination.~        3. To assess the safety of the vaccine.~        4. Evaluate predictors of serologic non-response in young, healthy individuals receiving a~          standard course of HBV immunization~        5. To compare the immunological profile before and after a standard HBV vaccination regimen~          on non-responders and responders~        6. Establish a rapid test for measuring CMI after being HBV vaccinated.~      A total of 400 healthy volunteers receive a standard course of immunization with a combined~     hepatitis A and B vaccine (Twinrix®) at 0, 1, and 6 months. Blood is drawn at 0 and 8 months~     from all participants. The blood will be analysed to see if there is antibodies or/and if~     there is mounted a cellular immune response by measuring on parameters called cytokines.~   "
161525|NCT01451788|"~     The Finnish Paediatric Orthopaedic Study Group will perform a prospective randomized,~     multicenter, clinical trial comparing Gelatin matrix with human derived thrombin (Floseal,~     Baxter) and without use of Floseal in adolescents undergoing posterior spinal deformity~     surgery for AIS (adolescent idiopathic scoliosis between 45 and 90 degrees) in Turku, Tampare~     and Helsinki Children's Hospitals. Sixty patients will be randomized into the intervention~     group receiving Floseal (n=30) and control group not receiving Floseal (n=30). Each~     University Hospital will treat 10 Floseal and 10 conventional treated scoliosis patients~     (block randomization). Both treatment groups will be allowed to use conventional blood saving~     methods.~   "
161526|NCT01451775|"~     Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and~     assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under~     fasting conditions.~   "
161527|NCT01451762|"~     Pain after ambulatory surgery remains an unsolved problem in The United States and Europe. It~     is associated with delayed hospital discharge and it can result to an increased opioid~     consumption with adverse side effects. The concept of multimodal analgesic technique was~     introduced more than 15 years ago and several techniques have been studied over the years~     including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids,~     ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal~     nociceptors and C-fibers, producing pain which is further increased by neurogenically~     mediated release of substance P from afferent pain fibers. Several non-selective or H1~     -selective histamine receptors antagonists have been demonstrated in animal models and~     clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing~     properties without adverse sedative effects in patients undergoing abdominal hysterectomy.~      Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing~     postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative~     pain and other important outcomes after ambulatory surgery such as time to meet discharge~     criteria have not being studied.~      The MQOR 40 is a validated instrument that was specifically design to evaluate patient~     recovery after anesthesia and surgery. This instrument can be particularly valid to examine~     interventions which affect different spheres of patient recovery as is the case of~     diphenhydramine. The objective of this study is to determine a dose response effect of~     preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery.~     The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease~     postoperative pain, opioid consumption and opioid related side effects after ambulatory~     surgery.~      The research question: Does a preoperative dose of diphenhydramine improve postoperative~     quality of recovery after ambulatory surgery? The hypothesis of this study is that~     preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and~     vomiting (PONV), sleep which will translate in a better overall quality of recovery.~   "
161528|NCT01451749|"~     The purpose of this phase III study is to further evaluate the effects of shenwu capsule, a~     traditional Chinese herbal medicine, on cognition, function and memory in patients with~     amnestic mild cognitive impairment (MCI) who are at greater risk for developing Alzheimer's~     disease, in a 6-month supervised protocol of a traditional Chinese herbal medicine. The~     results of this study may provide support for a relatively simple and inexpensive treatment~     strategy with herbal therapy that specifically targets individuals with the mild cognitive~     impairment that directly influence risk of developing dementia for older adults.~   "
161529|NCT01451736|"~     This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting~     injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode~     schizophrenia.~   "
161530|NCT01451723|"~     The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple~     Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate~     (a chemical that reflects the number of neurons and their metabolism) over one year between~     people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS~     treated with a matching sugar pill.~   "
161531|NCT01451710|"~     This is a single center,prospective,no-controlled clinical trial~   "
161532|NCT01451697|"~     The primary aim of this pilot randomized controlled trial is to examine whether cognitive~     remediation, compared to a placebo, improves attention and related cognitive functions in~     patients with compulsive hoarding. The primary hypothesis is that compulsive hoarding~     patients who are treated with cognitive remediation will demonstrate improved cognitive~     skills at post-treatment compared to patients receiving placebo. This will be especially true~     of attention; memory and executive function skills may also be improved.~   "
161533|NCT01451684|"~     This is an observational study to aid in the development of a non-invasive prenatal test that~     may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and~     asked to provide a blood sample to be used for general test development purposes.~   "
161534|NCT01451671|"~     This is an observational study to develop and evaluate a blood based prenatal blood test.~     Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be~     eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical~     data that will be recorded on a case report form. All samples and clinical data will be~     stripped of subject identifiers prior to submission to Ariosa.~   "
161540|NCT01451593|"~     Optic neuritis is caused by inflammation of the optic nerve and causes loss of vision in the~     affected eye. It is often associated with multiple sclerosis. Loss of vision after an attack~     of optic neuritis is caused by damage to the nerve fibres in the optic nerve. There are a~     number of factors that contribute to nerve fibre damage including increased levels of sodium~     within them, so blocking sodium entry could help to protect them against damage.~      The purpose of this study is determine whether phenytoin (which blocks sodium entry into~     cells) can protect against loss of nerve fibres and prevent loss of vision after optic~     neuritis.~   "
161541|NCT01451580|"~     To determine the overall objective response rate of pegylated liposomal doxorubicin~     （Lipo-Dox）combined with cyclophosphamide/5-FU as second-line treatment in patients with~     metastatic breast cancer.~   "
161542|NCT01451567|"~     The purpose of this study is to examine the effect of a structured personalised ergonomic~     intervention program for hospital nurses with musculoskeletal complains.~   "
161543|NCT01451554|"~     To date, no studies have been published assessing the effectiveness of portion control~     interventions in a primary care setting. The investigators will conduct a pilot study to~     assess the effectiveness of an intervention including a portion control plate and dietary~     counseling for weight loss among obese patients in a general medicine primary care practice.~   "
161544|NCT01451541|"~     This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group,~     efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and~     premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.~   "
161545|NCT01451528|"~     This open label trial is conducted to investigate the efficacy and safety of umbilical cord~     blood therapy for chronic traumatic brain injury patients.~      The study hypothesis is that the participants will show significant improvement in cognition~     and function after Umbilical cord blood (UCB) transplantation.~   "
161546|NCT01451515|"~     This is a phase II clinical trial using risk-adapted therapy. The treatment is acute~     lymphoblastic leukemia (ALL)-based therapy, using multi-agent regimens comprising of~     induction, consolidation, and continuation (maintenance) phases delivered over 24-30 months.~     Participants will be classified into 3 treatment stratums, based on bone marrow/peripheral~     blood lymphoma cells involvement at diagnosis and day 8 for T-lymphoblastic lymphoma and bone~     marrow/peripheral blood lymphoma cells involvement at diagnosis for B-lymphoblastic lymphoma.~      The Primary Objective of this study is:~      To improve the outcome of children with lymphoblastic lymphoma (LL) who have minimal~     disseminated disease (MDD) equal to or more than 1% at diagnosis by using MDD- and minimal~     residual disease (MRD)- based risk-adapted therapy.~      The Secondary Objectives of this study are:~        -  To determine event-free and overall survival~        -  Investigate the relationship between Day 8 MRD and MDD results and EFS~   "
161547|NCT01451502|"~     For the next 5‐10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB)~     inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While~     Food and Drug Administration (FDA)‐licensed units will be prioritized, it will always be~     possible that an unlicensed unit will have known attributes, making it a better source of~     cells for the given indication. Because of the wide variety of current and potential~     indications as a source of cells for hematopoietic reconstitution or other form of cellular~     therapy, it is critical that the investigators have access to unlicensed UCB units.~   "
161548|NCT01451489|"~     This is a prospective,multicentre study to compare the efficacy, safety, tolerability and~     relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis~     (FSGS).~   "
161549|NCT01451476|"~     Skin aging is a complex process involving genetic and environmental factors. The~     investigators hope to learn more about how human genes and their function can contribute to~     skin aging and human health.~   "
161550|NCT01451463|"~     In individuals with Huntington's disease (HD), chorea may contribute to balance problems and~     difficulties with walking, sit to stand transfers and stair climbing that in turn may~     contribute to high fall rates. Xenazine (tetrabenazine) is a monoamine-depleting drug that is~     commonly used to reduce chorea.~      The purpose of this study is to compare: 1) spatial and temporal gait measures, 2)~     performance on functional mobility measures, and 3) amount of daily walking activity before~     and after administration of Xenazine in individuals with HD. It is hypothesized that the use~     of Xenazine to decrease chorea will improve functions of 1) gait, 2) sit-to-stand transfers~     3) stair climbing and 4) overall daily physical activity and function.~   "
161551|NCT01451450|"~     This study will assess the clinical potency of several exposure levels of QGE031 in~     decreasing the sensitivity against peanut allergen.~   "
161552|NCT01451437|"~     This is a study of MK-8242 alone and in combination with cytarabine in adult participants~     with refractory or recurrent acute myelogenous leukemia (AML). The study will have 2 Arms.~     Arm A is for participants with refractory or recurrent AML who are considered ineligible for~     standard chemotherapy. In Part 1 of Arm A, participants will receive MK-8242 monotherapy in~     escalating doses to determine the recommended phase 2 dose [RP2D]. In Part 2, participants~     will receive monotherapy with MK-8242 to confirm the RP2D and assess preliminary efficacy.~     Arm B is for participants with recurrent AML following an initial complete remission (CR) or~     CR with incomplete marrow recovery (CRi) of 6 to 12 months duration. In Part 1 of Arm B,~     participants will receive MK-8242 in escalating doses + cytarabine to determine the RP2D in~     combination with cytarabine. In Part 2, participants will receive MK-8242 + cytarabine to~     confirm the RP2D and assess preliminary efficacy. The pharmacokinetics of MK-8242 will be~     studied in both arms. With Amendment 4 (22 August 2013) a 21-day dosing cycle is added, with~     MK-8242 being given on Days 1-7 of each 21-day cycle in both the monotherapy and combination~     therapy arms; data from Arm A will be used to determine whether a participant receives 21-day~     or 28-day therapy in Arm B.~   "
161553|NCT01451424|"~     To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of~     Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be~     administered vaginally.~   "
161554|NCT01451411|"~     The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of~     intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in~     blood.~   "
161574|NCT01451151|"~     The purpose of the the study is to evaluate the ability of injections of Ji Gami(TM) C to~     induce hair growth in male and female subjects with hair loss.~   "
161555|NCT01451398|"~     Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on~     either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or~     two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or~     Technosphere Powder (placebo) added to their oral antidiabetic drugs.~   "
161556|NCT01451385|"~     The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35~     days use as evaluated with physical exam, vital signs, pulse oximetry, clinical laboratory~     tests, and AEs.~   "
161557|NCT01451372|"~     The aim of this study is to document the routine practice in continuous glucose monitoring~     (CGM) in patients treated with sensor-augmented pump therapy and to assess clinical outcome~     (HbA1c) before the start of the sensor use to the end of the follow-up period. Moreover, data~     on treatment satisfaction, and fear of hypoglycemia, cost of the therapy, side effects and~     treatment interruption will be collected.~   "
161558|NCT01451359|"~     Because an endobronchial valve is a one-way inspiratory airway blocker, it is hypothesized~     that it could be also used for controlling persistent air leaks while maintaining the~     drainage of secretions. The U.S. Food and Drug Administration approved in October 2008 the~     Spiration valve system designed to control air leaks in the lung that persist after lung~     surgery. This prospective observational study aims to evaluate the efficacy and safety of~     Spiration endobronchial valves in a prospective series of consecutive patients with a~     prolonged persistent air leak after anatomic surgical resection for cancer.~   "
161559|NCT01451346|"~     This was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot~     study to obtain data on size and variance of treatment effects in subjects with mild to~     moderate Psoriasis.~   "
161560|NCT01451333|"~     Persistent HIV infection in the central nervous system (CNS) compartment may put subjects at~     risk of developing HIV-related brain disease. Important factors associated with the~     development of HIV-related brain disease include therapeutic concentrations of antiretroviral~     drugs in the CNS. Conflicting evidence regarding the CNS exposure of the antiretroviral drug~     used for the encore1 study, efavirenz (EFV) have been described in related studies. There~     were recent study of two small series assessment of EFV exposure in the cerebral spinal fluid~     (CSF); one group reported small detectable EFV concentrations, while another observed~     undetectable EFV exposure in the CSF. Also, in a larger reported series comprising of 80~     subjects on EFV-containing antiretroviral therapy, a CSF to plasma concentration suggested~     that there is limited movement of EFV out of the CSF. In HIV-1 infected subjects at steady~     state, EFV plasma level parameters are dose proportional following 200mg, 400mg, and 600mg~     daily doses. The CNS exposure of EFV at different daily dosing has not been described.~   "
161561|NCT01451320|"~     Despite high mortality and morbidity, the best treatment strategies for prosthetic valve~     thrombosis (PVT) have been controversial. In this study the investigators wanted to identify~     the most effective and safe regimen among different thrombolytic strategies.Transesophageal~     echocardiography (TEE) guided thrombolytic treatment was administered to 182 consecutive~     patients with PVT in 220 different episodes (156 women, mean age 43.2±13.06 years) between~     1993 and 2009. These regimens included rapid streptokinase (Group I, 16 episodes), slow~     streptokinase (Group II, 41 episodes), high dose (100 mg) tissue plasminogen activator (t-PA)~     (Group III, 12 episodes), half-dose (50 mg) slow infusion (6-hours) of t-PA without bolus~     (Group IV, 27 episodes), and low dose (25 mg) and slow infusion (6-hours) of t-PA without~     bolus (Group V, 124 episodes). The study endpoints were thrombolytic success and in-hospital~     mortality and non-fatal complication rates.~   "
161562|NCT01451307|"~     The aim of this single center study is to measure the impact of standardized neonatal~     pediatric surgeries due to gastrointestinal malformations on the children's motor and~     cognitive development and psycho-emotional competence.~      To measure the neurodevelopment, the children will be tested with the Bayley Scales of Infant~     Development II Assessment.~   "
161563|NCT01451294|"~     Carotid endarterectomy (CEA) is the recommended treatment for symptomatic high degree~     stenosis of the internal carotid artery (ICA). ICA obstruction is often associated with an~     impaired cerebral autoregulation, implicating that cerebral perfusion pressure becomes~     dependent on systemic blood pressure. Therefore, to maintain cerebral perfusion pressure in~     this type of patients intraoperative hypotension needs to be avoided. Different short-acting~     agents such as phenylephrine, (a drug with vasoconstrictive properties), or ephedrine (a drug~     with vasoconstrictive properties combined with an increase in heart rate) can be used to~     correct intra-operative hypotension. In healthy subjects these agents affect the cerebral~     perfusion differently despite an identical effect on the systemic blood pressure. Cerebral~     perfusion decreases after phenylephrine administration while it is preserved after the use of~     ephedrine. The optimal agent for correcting hypotension in CEA patients, and thus in a~     situation of an impaired cerebral autoregulation, is unknown.~      Therefore, the investigators propose to perform a prospective study observing the effect of~     phenylephrine and ephedrine on cerebral perfusion to make a recommendation regarding the use~     of either phenylephrine or ephedrine during CEA.~   "
161575|NCT01451138|"~     The purpose of this study is to evaluate the ability of injections of Ji Gami(TM) N and Ji~     Gami(TM) NDO to induce hair growth in male and female subjects with hair loss.~   "
161576|NCT01451125|"~     The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji~     Gami(TM) DO in combination with minoxidil to induce hair growth in male and female subjects~     with hair loss.~   "
161577|NCT01451112|"~     Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in~     male and female subjects with hair loss.~   "
161578|NCT01451099|"~     Evaluate the ability of Ji Gami(TM) DO to induce hair growth in male and female subjects with~     hair loss.~   "
161579|NCT01451086|"~     Pneumococcal infection is a leading cause of death throughout the world and a major cause of~     pneumonia, bacteremia, meningitis, and otitis media.~      It has been established that purified pneumococcal capsular polysaccharides induce antibody~     production and such antibody is effective in preventing pneumococcal disease. Clinical~     studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in~     polyvalent vaccines. Studies of 23-valent pneumococcal vaccine in children of two years old~     and older and in adults of all ages have showed immunogenic response. In order to provide~     more evidence for the immunogenicity and the safety of the vaccine, a phase III clinical~     trial is planed to conduct.~   "
161564|NCT01451281|"~     Background:~      - Duchenne muscular dystrophy (DMD) is a disease in which the muscles are unable to make the~     protein dystrophin. Without this protein, the muscles become gradually weaker. A new medicine~     called GSK2402968 is being tested to see if it can help prevent or slow down this loss of~     muscle strength. In this study, boys with DMD and healthy volunteers will have different~     types of imaging studies to see which ones provide the best images of the muscles. This~     information will help researchers use these imaging techniques to test the safety and~     effectiveness of GSK2402968 and other agents.~      Objectives:~      - To test magnetic resonance imaging and ultrasound techniques that can detect changes in~     muscles of boys with DMD.~      Eligibility:~        -  Boys who have DMD and are in the GSK2402968 drug test study.~        -  Healthy boys of the same age as the above study participants.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Healthy volunteers will have one 2-hour visit with three tests. Magnetic resonance~          imaging (MRI) scans of the skeletal muscles and heart and diaphragm muscles will be~          carried out. Muscle ultrasound imaging of leg and arm muscles will also be done.~          Participants should not perform heavy physical activity like school sports or long walks~          during the week before the visit.~        -  Participants in the GSK2402968 study will have the same series of tests as the healthy~          volunteers. The tests will be given during the study screening phase. They will be~          repeated after 3 months and 6 months of receiving the study agent (GSK2402968 or~          placebo) and at 6 months after stopping the GSK study.~   "
161565|NCT01451268|"~     The study's primary objective is to determine the maximum tolerated dose (MTD) and~     dose-limiting toxicity (DLT) of Panobinostat when administered within 150 days after~     hematopoietic stem cell transplantation (HSCT) and given in conjunction with standard~     immunosuppressive therapy after HSCT for patients with high-risk Myelodysplastic Syndrome~     (MDS) or Acute Myeloid Leukemia (AML).~      Secondary objectives are~        -  To determine safety and tolerability of panobinostat~        -  To determine overall and disease-free survival at 12 months after HSCT~        -  To evaluate immunoregulatory properties of panobinostat~        -  To evaluate patient-reported health-related quality of life (HRQL)~      The hypothesis of this study is that panobinostat can be an effective drug in preventing~     relapse of MDS and AML patients with high-risk features after hematopoietic stem cell~     transplantation with reduced-intensity conditioning (RIC-HSCT) while at the same time~     reducing graft-versus-host disease (GvHD) with preservation of graft-versus-leukemia (GvL)~     effect.~   "
161566|NCT01451255|"~     Cardiac magnetic resonance imaging has emerged as a potential valuable test for the early~     detection of Pulmonary Arterial Hypertension. A number of reports have provided some~     preliminary evidence that Pulmonary Artery (PA) stiffness may be accurately detected by~     imaging of the pulmonary artery in order to measure PA stiffness. In addition, cardiac MRI~     could play provide early and effective treatment for Pulmonary Arterial Hypertension (PAH).~   "
161567|NCT01451242|"~     Following a brain injury (BI) in addition to all other systems, there can be a failure in the~     control of the autonomic system activity. Heart rate (HR) has its own normal variability.~     Heart rate is controlled by the Sympathetic and Parasympathetic systems. Therefore,~     monitoring HR variability (HRV) can help us evaluate the balance of the two systems and their~     efficiency.Decrease in HRV was found to be in correlation with death among patients in the~     acute stage following ABI. Decrease in HRV is a pre-stage of HR irregularity and ventricular~     fibrillation.This disturbance can have a great impact on the patients health condition. In~     addition there was found an inverse correlation between this situation and the rehabilitation~     outcomes. Based on this data there is a great importance in monitoring HRV during~     rehabilitation among patients following BI while the patients are required to perform~     physical activity.The aim of this work is to check whether we can replace the traditional way~     of measuring HR by EKG Holter (gold standard) with a more simple,accessible tool-the POLAR~     watch.~      The aim of this work is to check if the data collected from a POLAR watch is reliable~     compared to the data collected from an EKG holter.~   "
161568|NCT01451229|"~     The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of~     higenamine in healthy Chinese subjects~   "
161569|NCT01451216|"~     Balance control is the sum action of the sense and reaction systems. In order to perform~     different activities in different postures one must have the ability to control and to adjust~     his balance in different conditions.A deficit in brain action following injury, disease or~     aging can undermine the ability to control balance and increase the risk to fall.The~     limitation in gait and mobility can increase morbidity. There is a limited number of tools~     evaluating and recording balance control ability. Most of this tools are observational and~     can be used in the clinical field. The aim of this work is to estimate the feasibility of an~     objective tool that can evaluate balance by tracking objective quantitative measures during~     the standard physical therapy session without using an expensive equipment. By using this~     tool the therapist can monitor the patient and collect quantitive data while performing tasks~     while keeping balance. This tool will allow the therapist to detect changes in balance and~     evaluate the effect of different conditions on the patients balance. This tool is based on~     the well known functional reach test. The addition of this tool to the test is the use of a~     simple camera and a computer softwear that will collect the data and analyze it while~     performing the test. This tool will give the therapist information on the responsiveness and~     the spatiotemporal measures of the performance. The aim of this work is to check what is the~     contribution of spatiotemporal measures of the functional reach test among patients suffering~     from acquired brain injury to the understanding of the motor function and balance control of~     people suffering from brain injury. .~   "
161570|NCT01451203|"~     The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with~     methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis~     (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of~     radiographically confirmed joint damage progression over a one-year period as a primary~     endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be~     discontinued, and the subjects will be monitored for one more year (the follow-up period) to~     investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory~     purposes.~   "
161571|NCT01451190|"~     Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female~     subjects with hair loss.~   "
161581|NCT01451060|"~     Anesthesia for cesarean section has been a great challenge for the anesthesiologist, for~     mother and fetus are closely related. So the challenge is to anesthetize the mother without~     interfering with the physiology of the fetus. The spinal block, although safe, are not free~     of complications if not treated properly, may be responsible for increased fetal morbidity.~     Among the major side effects, there is hypotension, with potentially serious consequences for~     the maternal-fetal dyad. Hypotension in pregnant women at low risk may not lead to major~     damage, but a pregnant woman with low reserves, as is the case of pregnant women with~     pre-eclampsia, any drop in blood pressure of the mother can bring harm to the welfare of~     mother and fetus. Based on the above, the purpose of this study is to compare the effects of~     maternal and perinatal treatment of hypotension with ephedrine or metaraminol in pregnant~     women with severe preeclampsia undergoing cesarean section under spinal anesthesia. There~     will be a randomized, double-blind, which will be included pregnant women with severe~     preeclampsia with indication of cesarean section, gestational age above 34 weeks gestation~     and only.Will be Excluded women with hemorrhagic syndromes of pregnancy, HELLP syndrome,~     eclampsia, cardiovascular or cerebrovascular disease, fetal distress and absolute~     contraindications to spinal anesthesia.~      All patients are fully informed of the research objectives and will only be included in the~     study if they agree to participate and sign the Instrument of Consent. The project was~     designed following the recommendations of Resolution 196/96 of the National Health and the~     Declaration of Helsinki for research involving human subjects (2000). In addition, the~     project was submitted to the Ethics Committee in Research of the Institute of Integrative~     Medicine Professor Fernando Figueira, is approved. The study will be conducted from June 2011~     to July 2012. The study variables are: consumption of metaraminol and ephedrine before and~     after birth, the occurrence of nausea and vomiting, incidence of maternal hypotension, the~     occurrence of reactive hypertension, occurrence of bradycardia, pH of umbilical cord, Apgar~     score 5 minutes, need for face mask ventilation and ICU admission.~   "
161582|NCT01451047|"~     To evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth~     in male and female subjects with hair loss~   "
161583|NCT01451034|"~     Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color~     changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical~     outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to~     evaluate clinical outcomes of WHYX cancers after endoscopic resection.~   "
161584|NCT01451021|"~     Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in~     male and female subjects with hair loss.~   "
161585|NCT01451008|"~     The intestinal ends must be rejoined after colonic resection. Conventional methods include~     sutured and stapled anastomoses, which is associated with 3-6% leakage after colonic surgery.~     The leakage of an anastomosis can cause serious consequences, such as abdominal infections~     and/or sepsis. Early detection of anastomotic leakage is the best way to avoid serious~     abdominal infections. The methods that are used today to detect leaks are unfortunately not~     very accurate. These methods include monitoring symptoms, temperature, and CRP-levels, and~     performing abdominal examinations and tomography scans. Because of the difficulties in~     objectively assessing these parameters, the anastomotic leaks are often diagnosed late. When~     reoperation is required, a permanent stoma may be made at the level of the sigmoid colon. The~     CARP system has been developed to achieve a safe anastomosis. The CARP is designed to~     providing an improved contact surface between the two intestinal ends and the ability to~     precisely investigate the anastomosis during and after surgery using the catheters of the~     CARP system. Standardized use of the CARP to anastomose the large intestine may provide~     significant advantages in the field of colorectal surgery.~   "
161586|NCT01450995|"~     This is an open label, 6 month cross over study in 50 migraine patients fulfilling~     International Headache Society Classification criteria for migraine headache with and without~     aura having 2-6 migraines per month and not over 14 days a month of headaches in the previous~     3 months. Baseline Headache Impact Test -6 (HIT-6) will be obtained and 25 patients will~     administer Treximet as needed for 3 months and then 2 Aleve and 100mg Imitrex taken~     concomitantly as needed for 3 months. The other 25 patients will administer 2 Aleve and 100mg~     Imitrex taken concomitantly as needed for 3 months and then Treximet as needed for 3 months.~     In addition to Revised Patient Perception of Migraine Questionnaire (PPMQ-R)data, a detailed~     diary will be recorded regarding number of tablets taken per attack, compliance, rescue~     treatment, when patients treated their migraine attack (mild, moderate, or severe), onset of~     pain reduction (pain relief and pain free, and 24 hour pain relief and sustained pain free~     response.~   "
161587|NCT01450982|"~     The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics~     (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.~   "
161588|NCT01450969|"~     The PREFER Trial primary objective of the trial is to show how much radiation attenuation is~     provided by XPF in absolute and relative terms.~   "
161589|NCT01450956|"~     During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent~     studies have suggested that the paediatric myocardium is more sensitive to hypoxia and~     cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia~     and reperfusion injury has been investigated widely in adults. The investigators hypothesis~     that sevoflurane applied during cardiopulmonary bypass might afford better myocardial~     protection during paediatric cardiac surgery.~   "
161590|NCT01450943|"~     The primary objective of this study is to assess the effectiveness of cellular dermal~     replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing~     diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.~   "
161591|NCT01450930|"~     Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement~     dose in conditions of physical or psychological stress to prevent life threatening adrenal~     crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g.~     gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone~     dose is crucial. The study is conducted to offer patients the possibility to perform~     hydrocortisone self administration in emergency situations in a way of administration which~     is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of~     subcutaneous hydrocortisone administration will be studied and compared to intramuscular~     administration.~   "
161608|NCT01450709|"~     A specifically formulated probiotic product comprised of defined and tested microbial strains~     may afford renoprotection in what has been generally called Enteric DialysisTM. However, it~     is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the~     potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM)~     as a dietary supplement product for patients undergoing dialysis along with standardized care~     of treatment.~   "
161866|NCT01447316|"~     This is a short term study of the effects of bariatric surgery on body composition, gait~     parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly~     obese patients who are already scheduled for a bariatric surgical procedure.~   "
161592|NCT01450917|"~     Diaphragmatic contraction is controlled by phrenic nerve which consists of anterior rami of~     3rd- 5th cervical nerve roots. Usually, It can't be evaluated from history taking and~     physical examination. Thus the diaphragmatic elevation on chest radiograph is assumed to~     identify the phrenic nerve dysfunction. Normally, the right diaphragm is higher than the left~     side about 1.5 ± 0.9 centimeters or 0.5 ± 0.3 time of vertebral height. Although there are~     several methods to determine the diaphragmatic elevation from previous studies, the accuracy,~     reliability, intra and inter-observer variation are problem.~      Neurotization is the effective procedure to restore upper extremity function in root avulsion~     type. Phrenic nerve is one of the common donor nerves which used for this procedure. But~     sometimes, concomitant injury of this nerve can occur. Therefore, the investigators~     established Diaphragmatic height index (DHI) from chest radiograph to use as the diagnostic~     test for phrenic nerve dysfunction.~   "
161593|NCT01450904|"~     Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had the~     less postoperative pain and shorter recovery time compared to the conventional technique.~     With using MIS technique, less cut of quadriceps tendon was the key. It related to keep more~     quadriceps strength and improve functional performance after TKA. However, there was no~     previous studies about the effect of quadriceps incision length in the recovery time of the~     quadriceps strength. The investigators hypothesized that longer quadriceps incision affected~     the longer recovery time of quadriceps strength in MIS-TKA.~   "
161594|NCT01450891|"~     Background: New research criteria for the diagnosis of Alzheimer's disease (AD) have recently~     been developed to enable an early diagnosis of AD pathophysiology by relying on emerging~     biomarkers. To enable efficient allocation of health care resources, evidence is needed to~     support decision makers on the adoption of emerging biomarkers in clinical practice. The~     research goals are to 1) assess the diagnostic test accuracy (of current clinical diagnostic~     work-up and emerging biomarkers in Magnetic Resonance Imaging (MRI), Positron Emission~     Tomography (PET) and Cerebrospinal Fluid (CSF), 2) perform a cost-consequence analysis and 3)~     assess long-term cost-effectiveness by an economic model.~      Methods/design: In a cohort design 304 consecutive patients suspected of having a primary~     neurodegenerative disease are approached in four academic memory clinics and followed for two~     years. Clinical data and data on quality of life data, costs and emerging biomarkers are~     gathered.~      Diagnostic test accuracy is determined by relating the clinical practice and new research~     criteria diagnoses to the reference diagnosis. The clinical practice diagnosis at baseline is~     reflected by a consensus procedure among experts using clinical information only (no~     biomarkers). The diagnosis based on the new research criteria is reflected by decision rules~     that combine clinical and biomarker information. The reference diagnosis is determined by a~     consensus procedure among experts based on clinical information on the course of symptoms~     over a two-year time period.~      A decision analytic model is build combining available evidence from different resources~     among which (accuracy) results from the study, literature and expert opinion to assess~     long-term cost-effectiveness of the emerging biomarkers.~      Discussion: Several other multi-centre trials study the relative value of new biomarkers for~     early evaluation of AD and related disorders. The uniqueness of this study is the assessment~     of resource utilization and quality of life to enable an economic evaluation. The study~     results are generalizable to a population of patients who are referred to a memory clinic due~     to their memory problems.~   "
161595|NCT01450878|"~     Background : Numerous studies have outlined the cellular pleiotropic effects of~     erythropoietin (EPO) and their role in the prevention of ischemic-reperfusion lesion such as~     after acute ischemic injury of the brain or the heart. However, most of these studies were~     carried out in animal models and no definitive proof exists today to demonstrate that EPO has~     similar beneficial effects in human pathology.~      Purpose : The aim of the study is to demonstrate that in humans, EPO can protect against~     ischemic-reperfusion lesions in a model of ischemia i.e. kidney transplantation.~   "
161596|NCT01450865|"~     Slow axonal Kv7 potassium channels are found along unmyelinated axons and at the nodes of~     Ranvier of myelinated axons in peripheral nerve. As such the pharmacological activation of~     Kv7 channels offers a potential means of reducing the excitability of peripheral axons. To~     determine whether this is the case for human peripheral myelinated axons, the effect of the~     Kv7 channel agonist flupirtine on the electrical excitability of A fibres was examined in~     both isolated segments of human sural nerve in vitro and in motor axons of the median nerve~     supplying abductor pollicus brevis in vivo. Axonal excitability was assessed in 21 human~     sural nerve fascicles in vitro and in 20 volunteers in vivo using threshold tracking in QTRAC~     (© Institute of Neurology, London, UK). Strength-duration time constant, rheobase current,~     relative refractory period (RRP), post spike superexcitability at 5 and 7 ms and threshold~     electrotonus over the 90 100 ms period were used as indices of electrical excitability. In~     addition, suppression of ectopic discharge in a model of upper limb ischaemia.~   "
161597|NCT01450852|"~     Exercise has been used to help prevent or slow the progression of inflammation-related~     disease; however, the mechanism by which this activity may lower concentrations of~     inflammatory markers remains unclear. The melanocortin receptors 1,3 and 5 (MC1R, MC3R and~     MC5R) have been shown to function in an anti-inflammatory manner and have the potential to~     mediate the positive immune adaptations associated with regular physical activity.~      Preliminary data suggest that MC3R gene expression increases in whole blood after chronic~     exercise training. The primary aim of the current study is to explore whether this change in~     gene expression translates into alterations in MC1R, MC3R, or MC5R monocyte surface~     expression. The secondary aim is to examine the relationship between surface expression of~     these receptors and circulating inflammatory profiles.~      The investigators will recruit 42 untrained, healthy males and females aged 18-35 yrs. Half~     of the group will be placed on an exercise program for 15 weeks. The other half will serve as~     untrained control subjects. In addition to basic anthropometric measures, the investigators~     will measure concentrations of inflammatory and anti-inflammatory cytokines (ELISA) and cell~     surface expression of MC1R, MC3R, and MC5R on monocytes (flow cytometry).~   "
161598|NCT01450839|"~     This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied~     repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as~     the control.~   "
161609|NCT01450696|"~     This randomized, open-label, multicenter, international Phase IIIb study will compare the~     efficacy and safety of two Herceptin dosing regimens in combination with~     cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or~     gastro-esophageal junction adenocarcinoma. Participants who have not received prior treatment~     for metastatic disease will be randomized to receive Herceptin intravenously as either an~     8-milligram per kilogram (mg/kg) loading dose followed by 6 mg/kg every 3 weeks (q3w) as~     standard of care or an 8-mg/kg loading dose followed by 10 mg/kg q3w until disease~     progression. Capecitabine will be administered for 6 cycles at a dose of 800 milligrams per~     meter-squared (mg/m^2) orally twice a day on Days 1 to 14 of each 3-week cycle, and cisplatin~     will be administered intravenously for 6 cycles at a dose of 80 mg/m^2 on Day 1 of each~     3-week cycle. Herceptin will be continued until disease progression occurs.~   "
161867|NCT01447303|"~     This study will compare changes in outcomes following viscosupplementation for knee~     osteoarthritis.~   "
161599|NCT01450826|"~     The objectives of the study are: 1) Primary: Assess CINV efficacy of Aprepitant in~     combination with Ondansetron vs. Ondansetron alone in preventing acute and delayed CINV~     (Complete Control (CC): days 1-7) in brain tumor patients during adjuvant temozolomide~     therapy; and 2) Secondary: To assess the efficacy of Aprepitant in combination with~     Ondansetron vs Ondansetron alone in preventing acute CINV in brain tumor patients during the~     acute period (first 24 hours) of receiving adjuvant temozolomide therapy; 3)Secondary: To~     assess the efficacy of Aprepitant in combination with Ondansetron vs. Ondansetron alone in~     preventing delayed CINV (days 2-7); 4) Secondary: To assess the safety and tolerability of~     Aprepitant administered concomitantly with Ondansetron; 5) Exploratory: To assess the time to~     treatment failure of Ondansetron treatment with and without Aprepitant; 6) Exploratory: To~     explore the effects of age, gender, chemotherapy history, and concomitant glucocorticoid on~     the efficacy of Ondansetron treatment with and without Aprepitant; 7) Exploratory: To explore~     the impact of Aprepitant on quality of life and daily function.~   "
161600|NCT01450813|"~     The Bispectral Index (BIS) monitor is used in many operating rooms to provide information to~     the anesthesiologist about a patient's level of consciousness. The Composite Variability~     Index (CVI) is a new index that may provide the anesthesiologist with more information about~     the condition of the patient. The CVI is a measure of the combined variability in BIS~     (bispectral index) and frontal electromyography (EMG) activity that may be useful in~     assessing the nociception/anti-nociception balance for patients under general anesthesia.The~     purpose of this study is to determine if a commonly used anesthetic drug (rocuronium) affects~     the CVI measurement differently with different doses. Rocuronium is a neuromuscular blocking~     agent (NMBA) routinely used during surgery. It is expected that the group given the highest~     dose of rocuronium will have diminished CVI values.~      This study will randomize patients to one of four doses of rocuronium: no rocuronium, 0.2,~     0.4, and 0.6 milligrams per kilo of body weight; the last dose is the standard amount for~     adults. It is expected that the group given the highest dose of rocuronium will have~     diminished CVI values. By including intermediate doses, information about the function of CVI~     in states of less than full muscle relaxation, or paralysis, will be obtained. This~     information is critically important for the development of the composite variability index,~     because during general anesthesia patients are usually maintained in a state of less than~     full paralysis. If the CVI response to stimulation in the intermediate groups is similar to~     the group receiving no rocuronium, the monitor may find wide clinical applicability. If the~     response is similar to the maximal rocuronium group, the index may only be reliable in states~     with no muscle relaxant, which will greatly limit clinical utility.~   "
161601|NCT01450800|"~     This is a study of patients undergoing gynecologic surgery who require post-operative~     catheterization to determine if prophylactic antibiotic treatment decreases the risk of~     post-operative urinary tract infection in these patients.~   "
161602|NCT01450787|"~     The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This~     might help identify a group of patients at greater risk for dry eye complications. Diabetics~     have been shown to have poor ocular surface healing and might benefit from dry eye therapy~     earlier if they are shown to be at greater risk for dry eyes.~   "
161603|NCT01450774|"~     This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way~     cross-over study in asthmatic children already treated with inhaled corticosteroids.~   "
161604|NCT01450761|"~     The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and~     Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell~     Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.~   "
161605|NCT01450748|"~     Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and hypopharynx,~     is a contributing factor to hoarseness, throat clearing, throat pain, and globus sensation.~     The therapeutic effect of proton pump inhibitors (PPIs) is controversial because a high~     placebo effect can be observed. Sodium Alginate is an effective medication indicated for~     symptomatic treatment of gastroesophageal reflux. This randomized, double-blind,~     placebo-controlled study aims to evaluate the efficacy and safety profile of sodium alginates~     oral suspension (50 mg/ml) 20 ml 3 times daily for the treatment of with LPR patients in~     Taiwan. Efficacy assessments include mean reduction in the total reflux symptom index (RSI)~     score after 4 and 8 weeks treatment, mean reduction in the total reflux finding score (RFS)~     after 4 and 8 weeks treatment, mean changes in the total numbers of reflux episodes as~     measured by 24-hour ambulatory combined impedance-pH monitoring after 1 day and 8 weeks~     treatment. Safety assessments include incidence of adverse events. The study hypothesis is~     sodium alginate is superior over placebo in relieving LPR symptoms.~   "
161606|NCT01450735|"~     The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR is~     indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails. This~     study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS~     device.~   "
161607|NCT01450722|"~     Chronic lower limb ischemia due to atherosclerosis causes significant morbidity especially in~     elderly: the prevalence of asymptomatic obstructive peripheral atherosclerosis among 40-74~     old is 4-22%. The prevalence of its milder symptomatic manifestation, intermittent~     claudication among 40 years old men is about 1% and among 70 years old it is 7%. In about 10%~     of the patients the ischemia worsens to threat the vitality of the limb. Although~     intermittent claudication has a benign prognosis and can often treated conservatively, more~     severe forms with extensive arterial obstructions require revascularization, either open~     surgical or endovascular. Surgical bypass operations are currently the standard reference for~     treating long femoral artery obstructions. Surgical bypass operations are accompanied by~     significant acute complications and late adverse effects, especially in patients with~     associated cardio-cerebrovascular and pulmonary diseases, and less invasive, safe, and~     effective endovascular therapies are seeked for. The long term patency rates of infrainguinal~     balloon angioplasty (PTA) vary largely in different studies but they are mostly poor when~     long femoral arterial obstructions have been treated. Drug eluting stents have shown great~     promise in coronary artery interventions. The purpose of this study is to compare Paclitaxel~     eluting Zilver PTX nitinol stent (Cook INC) with bypass surgery using PTFE graft to proximal~     popliteal artery in the treatment of long femoral artery obstructions (total length of 10-25~     cm) in a prospective, randomized, Finnish multi center trial with consecutive claudicant and~     chronic critical ischemia patients. The aim is to randomize altogether 400 patients during~     about two years in five universities and in 2-3 central hospitals. The primary end point is~     patency at 24 month follow up. Secondary end points are primary success at patient discharge,~     complications, 30-day mortality, target lesion revascularization, quality of life, and~     economical analysis.~   "
161610|NCT01450683|"~     This study evaluates if itraconazole causes a reduction in the serum levels of~     prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer~     (CRPC).~   "
161611|NCT01450670|"~     A specifically formulated probiotic product comprised of defined and tested microbial strains~     may afford renoprotection in what has been generally called Enteric DialysisTM. However, it~     is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the~     potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM)~     as a dietary supplement product for patients undergoing dialysis along with standardized care~     of treatment.~   "
161612|NCT01450657|"~     A specifically formulated probiotic product comprised of defined and tested microbial strains~     may afford renoprotection in what has been generally called Enteric DialysisTM. However, it~     is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the~     potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM)~     as a dietary supplement product for patients undergoing standardized care of treatment for~     their CKD stage 3 and stage 4 conditions.~   "
161613|NCT01450644|"~     The investigators hypothesise that H2H will result in improved symptom control and quality of~     life and may be more cost-effective than standard best practice.~      Interstitial Lung Disease (ILD) is a lung condition characterised by progressive scarring -~     known as fibrosis. This is especially seen in patients with idiopathic pulmonary fibrosis~     (IPF). There around 2,000 new patients diagnosed in the UK every year with a similar number~     of deaths.~      Fibrotic-ILD causes breathing to slowly deteriorate and as there is no cure, an estimated~     two-thirds of patients die within five years of diagnosis. Patients suffer from many symptoms~     including shortness of breath, cough, low mood and fatigue which are currently being poorly~     managed. In addition, these patients suffer a poor health related quality of life whilst~     dying from their disease.~      In the later stages of their disease, these patients often end up in hospital (see appendix~     1a) when there is no proven or effective treatment. Many die there despite wishing to be~     looked after and die at home. These patients rarely receive palliative care which may help to~     improve their symptoms, quality of life, address end of life planning needs and prevent~     hospital admission. The Hospital2Home case conference conducted in the patient's home (or~     place of their choice) aims to address this. At the case conference involving the patient,~     their carers, a specialist nurse, and all the community health professionals, a care plan~     specific to the patient will be developed. Each health professional will be aware of their~     responsibility and duties. The investigators will look at whether this results in better~     symptom control and better quality of life for the patient and their carer. The investigators~     will also examine whether this prevents emergency hospital admission and allows patients to~     die in their preferred place. The investigators will compare patients who receive the service~     immediately with those who receive it after a delay.~   "
161614|NCT01450631|"~     The purpose of this study is to compare the post-surgical standard-of-care dressing to the~     Prevena™ Incision Management System in women undergoing Cesarean section surgery.~   "
161615|NCT01450618|"~     This study will be a retrospective observational study assessing identifiable tolerability~     problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV)~     patients treated with cART regimens including one of four different protease inhibitors~     [Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)] and the~     impact of these identifiable tolerability problems on PI persistence, healthcare utilization,~     and healthcare costs.~   "
161616|NCT01450605|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Reyataz® so that the regulatory authority can manage the marketing approval~     properly~   "
161617|NCT01450592|"~     The study is designed as an interventional (as blood investigations will be done) dietary~     survey of diabetic & non-diabetic population sample of India to understand & compare dietary~     patterns among them.The study objective is to find out amount of carbohydrate content of~     daily diet of diabetic population study . This study does not intend to study the effect of~     any drugs. There will be 2 groups : Type 2 diabetics and non diabetic population. The study~     will begin after the study approval by ethics committee. The subject will involved after they~     sign the consent form. The study involves general examination of patients, collection of data~     like history of disease, interview by dietitian with the help of questionnaire, blood~     investigations (only in diabetic population only) and glycaemic control status of only~     diabetic population.The study is planned to be enroll 800 subjects (400 in each groups) from~     10 study centers spread across India. The study data will be analyzed with appropriate~     statistical methods.~   "
161618|NCT01450579|"~     This trial is to investigate the clinically recommended dosage for ASP7373 based on the~     comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy~     adults.~   "
161619|NCT01450566|"~     Ureteroscopy (URS) is minimally invasive procedure for management of renal stones. URS is~     often involves concomitant of an indwelling ureteral stents. Placements of these stents~     include pain, bladder irritability, infection, migration, encrustation and stones.~      Pain is one of most significant problem of ureteral stents. There are no satisfactory~     measures to deal with this problem. A novel approach to manage the pain is to load a drug~     onto ureteral stent and deliver the drug into the urinary tract at controlled release rate.~      Lidocaine has been proven to be effective for management of the pain associated with~     interstitial cystitis. This agent has the potential for management of post-URS pain.~   "
161620|NCT01450553|"~     A 15-gene lung signature was created to identify predictive and prognostic biomarkers for~     Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a~     microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk and~     low risk cohorts with significantly different survivals.~      Using fresh frozen tissue can be challenging, so this study attempts simplify the process by~     migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin~     Fixed Paraffin Embedded (FFPE) and RNAlater.~      The gene expressions of the different tissue formats will be compared to see if the fresh~     frozen tissue results are similar to the alternative tissue formats.~   "
161621|NCT01450527|"~     This is a prospective observational study done to know the etiology and outcomes of Acute~     Respiratory Distress Syndrome.~   "
161622|NCT01450514|"~     This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a~     single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment~     with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and~     clinical outcome of chronic schizophrenic patients with residual, so-called 'positive'~     symptoms, as well as on cognition, motivation, subjective well-being of patients, negative~     symptoms, general psychopathological symptoms and safety/tolerability.~   "
161693|NCT01449578|"~     This Phase 1 study will explore the safety, tolerability, and pharmacokinetics of single~     doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg BID~     dexpramipexole in healthy volunteers.~   "
161623|NCT01450501|"~     Q-fever is a zoonosis caused by Coxiella burnetii, an intracellular bacterium. Since the~     epidemic outbreak of acute Q-fever in Holland nearly 4030 people have been registered with~     the acute form of the disease. Knowing that only 40% of all infected people develop symptoms,~     the number of infected people (and potential candidates for chronic Q-fever) are much higher.~     Chronic Q-fever generally manifest itself after a couple of months or years after the primary~     infection (in 1-5% of all cases). The clinical presentation can be a life-threatening and~     frequently underdiagnosed disease, as endocarditis, infected aneurysm and vascular prosthesis~     or chronic Q-fever related to pregnancy and immunecompromised patients. That's why a~     screening program is started in the endemic area and trace patients with chronic Q-fever. So~     eventually, a greater group of patients with chronic vascular Q-fever can be described. In~     addition, there is still no therapeutic guideline for management of chronic Q-fever in~     patient with a vascular chronic Q-fever.~      Patients with an aneurysm or vascular graft will be screened for chronic Q-fever. Patients~     with chronic Q-fever will be included in a follow-up program, in which additional research~     and treatment will start. The initial treatment of patients with chronic Q-fever is~     doxycycline and hydroxychloroquine for at least 18 months. In addition, patients will be~     monitored in 3-monthly controls, blood samples and imaging will be done. Parameters as~     complaints, titers, circulating DNA, grow of aneurysm, complications etc. will be~     investigated.~      Ultimately, the current therapeutic guideline for management of C. burnetii will be evaluated~     if it can also be applied for patients with vascular chronic Q-fever.~   "
161624|NCT01450488|"~     The purpose of this study is to evaluate the activity of oral AB1010, administered at two~     dose levels during 3 years to patients with primary or secondary progressive multiple~     sclerosis.~   "
161625|NCT01450475|"~     Cardiac surgery is associated with cardiac and cerebral injury because of~     ischemia/reperfusion in approximately one third of cases. Ischemic preconditioning (IPC),~     have been shown to reduce the extent of myocardial infarction (MI). As another ischemic~     conditioning, remote ischemic postconditioning, limits MI size in animal models. The purpose~     of this study is to evaluate the cardiac and cerebral protective effect of remote ischemic~     postconditioning in children undergoing cardiac surgery, as a single-center, randomized~     controlled trial.~   "
161626|NCT01450462|"~     Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in~     the vagina declines and is replaced by other bacterial species. BV is the most common vaginal~     infection worldwide, but the etiology of this complex condition is not clear. BV is~     associated with a 60% increased risk of HIV acquisition as well as numerous other detrimental~     reproductive outcomes. A profound racial disparity exists in BV prevalence in women in the~     United States (US): 23% of white women versus. 52% of black women have BV. The investigators~     hypothesize that inadequate vitamin D contributes to BV development and/or recurrence.~     Vitamin D is essential to immune function, serving both to stimulate mechanisms associated~     with pathogen elimination and to regulate immune response. According to~     nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two~     recent analyses, low vitamin D was associated with higher BV prevalence in pregnant~     African-Americans; a third replicated this finding in pregnant African-American and white~     women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to~     assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a~     public sexually transmitted disease (STD) clinic. This small (n=150), two-arm,~     placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform~     the development of future large-scale RCT design and implementation.~   "
161627|NCT01450449|"~     This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two~     treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status~     and extent of the surgical resection.~      This study will assess the effect of a one-week radiotherapy regimen in comparison with a~     three-week radiotherapy regimen on the survival of elderly and/or frail patients with~     glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly~     and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% -~     100%).~   "
161628|NCT01450436|"~     Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since~     the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic~     input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices and~     strategies have significantly evolved during these last years, influenced by Baker~     nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could~     perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity~     and cardio-vascular pathology prevalence in this target population at adulthood. In this~     context many studies emerged since 2000 and try to assess the trade-off between~     neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between~     heterogenous proteic input dispensed in our NICU (described by tercil methods on population)~     and fat mass phenotype variations at discharge (described by tercil methods); and its~     consequences on neurodevelopmental growth. Understanding how particular nutritional~     exposition could determine fatty phenotype and impact neurodevelopment is clearly our main~     goal.~   "
161629|NCT01450423|"~     Epilepsy is a chronic neurologic disorder characterized by seizures. Beside seizures people~     suffering from epilepsy experience several challenges related to education, work and everyday~     life such as learning-, problem-solving-, memory-, concentration-, attention difficulties and~     fatigue.~      It is generally approved that physical activity (PA) has a positive effect on physical as~     well as mental factors. However, people with epilepsy are found to be less active and PA is~     rarely offered or recommended as supplement to anti-epileptic medical treatment. Few studies~     have investigated the effect of PA in subjects with epilepsy and additional studies of high~     methodical quality are needed to enable evidence-based information and counselling.~      This study is carried through as a randomized controlled trial which investigates the effect~     of participation in a 10-week cardio exercise program in people with Juvenile Myoclonic~     Epilepsy aged 15-50.~      The study hypothesis is that participation in a 10-week cardio exercise program will induce a~     positive change in cognitive function (concentration and attention) and possibly in~     brain-derived neurotrophic factor (BDNF). In addition it is expected that the intensity and~     duration of the 10-week cardio exercise program is sufficient to cause changes in~     physiological parameters related to a reduced risk of lifestyle diseases.~   "
161630|NCT01450410|"~     Patients with premature ischemic heart disease (PIHD) and elevated levels of HDL-C present an~     altered composition of high-density lipoproteins (HDL) which is associated with a loss of~     their anti-atherogenic effects and of their arterial endothelium function.~      Objectives: To analyse if the treatment with nicotinic acid (NA)/Laropiprant can correct the~     alterations of the HDL composition and endothelial function in patients with PIHD and~     elevated HDL-C.~      Methods: A total of 46 subjects with PIHD who are stable in the 3 months prior to the Study,~     who continue in treatment with statins and have elevated concentrations of HDL-C (HDL-C~     ≥2.0mmol/L in females and ≥1.8mmol/L in males) and an LDL-C <100mg/dL. This is a~     double-blind, randomised Study; after 6 weeks of lifestyle stabilisation, the subjects will~     be treated with NA or placebo for 16 weeks. At the start and end of treatment, HDL~     composition will be studied through density gradient preparative ultracentrifuge separation~     and FBLC (fast protein liquid chromatography) and through the changes in vasodilation induced~     by the endothelium through ultrasound. Primary endpoint: change in the apoA1 content~     associated to treatment. Secondary endpoints: variations in the change of the brachial artery~     diameter with reactive hyperaemia and changes in the content of other lipid and protein~     components of HDL including apoA2, paraoxonase, amyloid A and LCAT. The changes in HDL~     composition and endothelial function will be assessed with an analysis of variance with~     repeated measurements and a 2x2 design.~   "
161631|NCT01450397|"~     The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.~   "
161632|NCT01450384|"~     This phase I trial studies the side effects and best dose of giving pemetrexed disodium and~     sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed~     disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of solid tumors~     by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib~     tosylate may kill more tumor cells.~   "
161633|NCT01450371|"~     Interferential electrical stimulation (IES) increases local blood flow. It is not known~     whether increases in blood flow may be caused by inhibition of sympathetic activity, mediated~     by muscle metaboreflex activity. The purpose of this study was to evaluate the effect of IES~     on metaboreflex activation in healthy subjects.~   "
161634|NCT01450358|"~     The objective of this study is to evaluate the consumption of antimicrobial therapy in~     patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to~     identify the etiological agents of sepsis.~   "
161635|NCT01450345|"~     The study carry out is to determine whether the use of oral pregabalin premedication to~     assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in~     post-operative pain management.~   "
161636|NCT01450332|"~     The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL~     prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as~     major adverse treatment events (AEs). it is designed to test the hypothesis that there is a~     difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using~     autografts and those in which such procedure was performed with the Tavor prosthesis.~   "
161637|NCT01450319|"~     This national, multicenter, open-label phase 2 study without any control arm aims to evaluate~     the activity of cetuximab monotherapy in the treatment of refractory colorectal cancer in~     subjects with K-RAS mutated and FcγRIIa polymorphism tumors, in which there is no therapeutic~     alternative for treatment. Failure of the first and second line conventional therapeutic~     lines was documented.~   "
161638|NCT01450306|"~     The aim of the present study is to determine whether people receiving d-cycloserine and~     exposure therapy show different brain reactions to symptom provocation compared to people~     receiving placebo and exposure therapy.~   "
161639|NCT01450293|"~     Infants in malaria-endemic regions of Africa are an important target for vaccination against~     malaria in view of the enormous disease burden of malaria in this population. The purpose of~     this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP~     candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here~     has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be~     protective against naturally acquired infection in the Gambia. Administration of AdCh63~     ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two~     weeks from the administration of routine infant immunisations, given according to the Gambian~     EPI.~   "
161640|NCT01450280|"~     This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63~     CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite~     protein. All volunteers recruited will be healthy adults. They will be primed with various~     doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a~     booster vaccination with MVA CS administered via intramuscular route. Safety data will be~     collected for each vaccination regimen. Secondary aim of this study will be to assess the~     immune responses generated by vaccination.~   "
161641|NCT01450267|"~     Cystic fibrosis (CF) is the most common inherited disease among the Caucasian population with~     considerable morbidity and reduced life expectancy.~      Excessive oxidants released by activated inflammatory cells and persisting infections are~     considered the main mechanism of damage of respiratory epithelium in CF.Glutathione (GSH)~     represents the first-line defence of the lung against oxidative stress-induced cell injury;~     however, a depletion of its levels has been observed in the airways of patients affected by~     CF. In vitro studies have showed that CFTR protein plays a pivotal role in transmembrane~     glutathione transport. Therapeutic approaches with inhaled GSH could improve the reduced lung~     antioxidant capacity in order to counterbalance the oxidant stress linked to the chronic~     airway inflammation and bacterial infection.~      Primary objective of the study is to investigate whether a 12 months treatment with inhaled~     GSH can improve airway obstruction in CF patients. Secondary objectives include the effects~     of GSH therapy on exercise capacity, body mass index (BMI), respiratory symptoms, quality of~     life, frequency of pulmonary exacerbations, hospital admissions, and antibiotic~     administration. Moreover the study will evaluate the effect of GSH therapy on markers of~     oxidative stress in exhaled breath condensate (EBC) and in serum, and on inflammatory markers~     on brushed nasal epithelial cells.~   "
161890|NCT01447004|"~     Heavy metal has been reported that it can cause attention deficit and behavioral disturbance.~     The investigators hypothesis is that heavy metal is associated with children with attention~     deficit/hyperactivity disorder(ADHD).~   "
161642|NCT01450254|"~     The purpose of this study is to:~        1. Analyze the short-term effects of external center of pressure manipulation of the foot~          in idiopathic hip osteoarthritis patients during gait on:~             1. Gait parameters (spatiotemporal, kinematic, and kinetic)~             2. Muscle activation patterns of the lower limbs and back~        2. Analyze the long-term effects (during the period of one year) of external center of~          pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait~          on:~             1. Gait parameters (spatiotemporal, kinematic, and kinetic)~             2. Motor learning and muscle activation patterns~             3. Energy consumption~             4. Pain, physical function, and quality of life~      The hypotheses of the study, in reference to the aforementioned study objectives are:~        1. Changes in foot center of pressure will have an immediate effect on gait parameters and~          muscle activation patterns of the lower limbs and back.~        2. Long-term manipulation of foot center of pressure, as a result of a year-long~          rehabilitation program using the AposTherapy Biomechanical System, will result in~          improvement in gait parameters, changes in muscle activation patterns as a result of new~          motor learning, improvement in energy consumption, decrease in pain, improvement in~          physical function, and improvement in quality of life.~   "
161643|NCT01450241|"~     The purpose of this study is to determine whether short-course antibiotic therapy is safe and~     effective for the treatment of cancer patients with febrile neutropenia.~   "
161644|NCT01450228|"~     KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy~     to improve sleep quality in over 55 years old primary insomnia patients. This is a bridging~     study to investigate the efficacy and safety of KI1001(Circadin®) in Korean patients.~   "
161645|NCT01450215|"~     This is:~        -  A prospective, randomized, open, phase II, multi-centre, interventional study. Patients~          who are in at least PR and have received lenalidomide as 2nd line treatment for MM will~          be recruited.~        -  The patients will be randomized into two groups. Group R will receive lenalidomide 25~          mg/day p.o. continuously for 21 days and group Rb will receive a similar dose of~          lenalidomide with the addition of 40 mg of dexamethasone p.o. on days 1, 8, 15 and 22 of~          every 28 day treatment cycle. Study includes a maximum of 24 cycles including two~          consolidating cycles per patients.~   "
161646|NCT01450202|"~     Compared with performing each procedure individually, performing two combined procedures such~     as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal~     distension and post-procedure pain because of longer procedure time related to more bowel~     insufflated gas than one procedure. To the best of the investigators knowledge, there has~     been no randomized controlled trial of CO2 versus air for insufflations during combined two~     procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials~     concerned CO2 insufflation in patients receiving sedation during colonoscopy.~      The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural~     abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of~     CO2 insufflation when it is used during procedure in sedated outpatients.~   "
161647|NCT01450189|"~     This pilot study will assess the feasibility for the potential public health benefit of~     behavioral and antiretroviral interventions during acute HIV infection.~      Central Hypothesis The investigators hypothesize that delivering behavioral and~     antiretroviral interventions to acutely infected persons will reduce onward transmission.~   "
161648|NCT01450176|"~     The purpose of this study is to compare patient satisfaction with Pataday (Olopatadine~     hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution~     1.5%) two times a day (BID).~   "
161649|NCT01450163|"~     Oxaliplatin (Ox) is part of most treatment regimens for colorectal cancer. However, it may~     induce side effects, such as a specific injury to peripheral nerves called neuropathy.~     Ox-induced neuropathy is frequently painful. The presence of pain after its administration~     may hamper the full chemotherapeutic treatment of patients with colorectal cancer receiving~     this agent. Recently, it has been suggested that the appearance of acute neuropathy after~     oxaliplatin (Ox) infusion could predict the distal polyneuropathy seen some months after~     treatment. These two adverse events related to Ox treatment probably share different~     mechanistic backgrounds. However, recent experimental data suggest that both types of~     peripheral neuropathies are able to induce central sensitization, a major step to the~     occurrence of chronic pain. Pregabalin is a molecule used to teat neuropathic pain since it~     can diminish the peripheral sensitization seen in this painful condition. Recently, it has~     also been shown that pregabalin can be used to treat neuropathic pain related to Ox~     treatment. In the present study, we will test the hypothesis that Pregabalin administrated~     exclusively for three days before and three days after the Ox infusion is able to prevent the~     occurrence of pain secondary to both the acute and chronic Ox-associated neuropathies. In the~     classical FLOX chemotherapeutic regimen, Ox is infused in nine sessions during a six-month~     period. Patients will be followed for a year and nerve conduction tests, quantitative sensory~     evaluation, pain, quality of life and functional scales will be used to assess the impact of~     this strategy in the prevention of pain. If this strategy proves to work, this information~     will have a major impact in the cancer prognosis of patients with colorectal cancer since Ox~     will be able to administer in its full dose, and will not be limited by neuropathic side~     effects.~   "
161650|NCT01450150|"~     Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or~     de-activate neurons in superficial regions of the brain through the induction of weak~     electric currents in the brain tissue delivered by two scalp electrodes. Initial studies have~     shown tDCS to be effective for treating major depressive disorder (MDD), although there are~     negative trials in the specialized literature. One reason for these discrepant results might~     be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is still~     insufficient to produce consistent clinical improvements. Thus, we intend to assess, in a~     sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over the~     left dorsolateral prefrontal cortex is associated with a significant clinical improvement~     when compared to sham tDCS. The investigators hypothesize that subjects receiving active tDCS~     will present with significantly higher response and remission rates at weeks 3.~   "
161694|NCT01449565|"~     Extended-release naltrexone (XR-NTX, VIVITROL) is an FDA-approved medication with efficacy in~     treating alcohol dependence and prevention of relapse to opioid dependence. It has shown~     promise in reducing relapse to amphetamine use among amphetamine-dependent, yet currently~     amphetamine-abstinent heterosexuals. The investigators will expand upon this promising work~     to determine whether monthly intramuscular injections of naltrexone will reduce~     methamphetamine (meth) use among actively using, meth-dependent men who have sex with men~     (MSM) in this double-blind randomized controlled trial of extended-release naltrexone versus~     placebo. The investigators will focus on MSM because of the disproportionate and intertwining~     epidemics of meth use and HIV in this population.~   "
161928|NCT01446497|"~     Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic~     (Timolol) ophthalmic solutions in normal tension glaucoma patients.~   "
161651|NCT01450137|"~     Giant-cell arteritis (GCA) is an immune-mediated disease that mostly affects people older~     than 50 years of age. Glucocorticoid (GC) treatment dramatically alters the symptoms and~     course of GCA, reducing the likelihood of vascular complications that could lead e.g. to~     blindness. However, relapses usually occur when GC dosages are tapered, resulting in frequent~     re-treatment with high cumulative dosages of GC over time with substantial toxicity and~     morbidity (e.g. diabetes mellitus, infections, enhanced cardiovascular risk, osteoporotic~     fractures, cataracts).~      Therefore, novel therapies are needed that effectively reduce the dose and duration of GC~     treatment and provide more durable remissions of GCA.~      Tocilizumab (TCZ) is a humanized monoclonal antibody directed against the human interleukin-6~     receptor (IL-6R). Elevated tissue and serum levels of IL-6 have been implicated in giant cell~     arteritis. Inhibition of IL-6 and/or its receptor therefore represents a new and novel~     approach for the treatment of RA.~      The primary endpoint is the proportion of patients that have achieved complete remission of~     disease after treatment with TCZ compared to treatment with placebo at week 12. All patients~     will receive glucocorticoids in a standardized form.~   "
161652|NCT01450124|"~     To determine the safety and tolerability of BOSWELAN in subjects with multiple sclerosis or~     clinically isolated syndrome and to describe the effect of Boswellic acids on the disease~     activity as assessed by monthly MRI measures.~   "
161653|NCT01450111|"~     Primary objective of this trial was to investigate the pharmacokinetics of single dose and~     repeated dose applications of lacosamide in healthy male Korean subjects.~   "
161654|NCT01450098|"~     The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and to~     compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese subjects~     and first generation Japanese subjects after receiving a single oral dose of LY2484595 in a~     fasted state, after eating a low-fat meal and after eating a high-fat meal.~   "
161655|NCT01450085|"~     The specific aims of this project are: (1) to compare the impact of using the routine~     screening and GeneXpert algorithms for TB case detection on Tuberculosis (TB)- and~     HIV-related outcomes; (2) to compare the impact of using the routine screening and GeneXpert~     algorithms for exclusion of TB prior to initiation of IPT and ART on TB- and HIV-related~     outcomes; and (3) to assess the relative cost-effectiveness of the routine screening and~     GeneXpert algorithms for TB case detection and exclusion of TB. The GeneXpert is a~     disruptive technology10 that could allow TB/HIV programs in resource-limited settings to~     leapfrog over solid and liquid culture-based TB diagnostic algorithms, and to remove a key~     barrier to scale up of ICF and IPT.~   "
161656|NCT01450072|"~     The Departments of Neurology and Neurosurgery are conducting this research study to evaluate~     the safety and effectiveness of intravascular angioplasty for the treatment of venous~     narrowing in the treatment of Multiple Sclerosis (MS).~   "
161657|NCT01450059|"~     The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed~     Newborns after spontaneous birth in comparison to cesarean section.~      This may have an influence on the risk of vertical HiV transmission.~   "
161658|NCT01450046|"~     The Principal Investigator believes that Vitamin E δ-Tocotrienol will slow the progression of~     pancreatic cancer cells. Therefore, the investigators must determine the safety and~     tolerability of Vitamin E δ-Tocotrienol in healthy participants before administering to~     cancer patients. The investigators will do this by giving participants a dose of up to1600 mg~     twice a day, not to exceed 3200 mg total for 14 consecutive days.~   "
161659|NCT01450033|"~     Adolescents with solid organ transplants have poorer outcomes than adults, and do not respond~     as well to post-rejection treatment. In addition to well-recognized declines in individual~     health-related quality of life, premature graft loss creates considerable health and economic~     burdens. High nonadherence rates among adolescents are believed to contribute majorly to~     rejection, premature allograft dysfunction and failure. Studies suggest that a~     telephone-based peer mentoring approach, with texting and e-communication, is a promising,~     practical means to promote medication adherence in adolescent solid organ transplant~     recipients. The study's main objectives are 1) to determine the efficacy of peer mentoring to~     improve medication adherence and health-related quality of life vs. usual care in adolescents~     and young adults with solid organ transplants, and 2) to determine the mechanisms through~     which peer mentoring impacts medication adherence and health-related quality of life.~   "
161660|NCT01450020|"~     This randomized clinical trial studies peer navigator education in improving survivorship~     care in African American breast cancer survivors. An educational intervention involving peer~     groups may help to improve the well-being and quality of life (QOL) in breast cancer~     survivors~   "
161661|NCT01450007|"~     Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral~     nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia,~     improve visual analog pain scores, decrease post-operative opioid use, and decrease~     post-operative nausea. No study has been published to determine if this effect is a result of~     systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at~     the injection site. This study is a prospective, randomized, double-blind, controlled study~     to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2)~     ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus~     intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three~     groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally~     in combination with ropivacaine for interscalene brachial plexus block will yield longer~     duration of sensory blockade as compared to ropivacaine alone without intravenous or~     perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This~     result will suggest that the effect of dexamethasone is a result of direct neuronal activity~     at the injection site versus systemic absorption.~   "
161662|NCT01449994|"~     The goal of the study is to prove efficacy of instrumental chiropractic treatment for leg~     pain in juvenile athletes.~      A randomized placebo controlled clinical trial including juvenile athletes with functional~     impairment and pain in thigh, leg or foot is performed.~      Hypothesis: Instrumental chiropractic treatment with the activator instrument following the~     activator methods diagnostic evaluation should lead to significant improvement of~     complaints and functional impairment compared to the control group treated by a deactivated~     instrument following a sham evaluation protocol.~   "
161663|NCT01449981|"~     This study is the first to develop and test in a randomized experimental design the efficacy~     of an integrated 12-step facilitation intervention tailored for young people. In the first~     phase of the study, the investigators are developing and revising a preliminary manual for~     the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and~     subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will~     integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the~     preliminary integrated TSF protocol. In the second phase of the study, the investigators will~     compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized experimental~     design for adolescent substance use disorder with 60 adolescents. As a result, the~     investigators will examine potential mechanisms that may underlie the efficacy of iTSF in~     improving alcohol and other drug use outcomes. The investigators will test group differences~     on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics Anonymous attendance~     and involvement) and whether these variables are associated with substance use outcomes.~   "
161664|NCT01449968|"~     The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce~     the geriatric hospital inappropriate (especially for emergencies) to 1 month.~      The primary endpoint: survival without hospitalization through the emergency inappropriate to~     1 month.~   "
161665|NCT01449955|"~     The purpose of the proposed study is to determine if pairing reactivation of a traumatic~     memory with a single administration of Rapamycin (e.g., Sirolimus) in men with combat-related~     Posttraumatic Stress Disorder leads to a reduction of the emotional strength of that~     particular traumatic memory.~      The following hypotheses will be tested:~        1. Traumatic memory reactivation paired with a single dose of Rapamycin will decrease~          objective measures of stress and self-report of stress during replay of the traumatic~          memory, relative to, subjects receiving placebo.~        2. Pairing administration of Rapamycin with traumatic memory reactivation will decrease~          symptoms of Posttraumatic Stress Disorder one month and three months later, relative to~          patients receiving placebo.~   "
161666|NCT01449942|"~     The purpose of this study is to determine whether an EBV-LMP1 targeted DNAzyme is effective~     in radiosensitization of nasopharyngeal carcinoma in combination with standard radiation~     therapy.~   "
161667|NCT01449929|"~     This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy~     (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg~     once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once~     daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside~     reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or~     tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and~     background NRTI selection. The primary analysis will take place after the last subject~     completes 48 weeks on therapy; an additional analysis will be conducted after the last~     subject completes Week 96 on study.~   "
161668|NCT01449916|"~     This study is a randomized control trial assessing the impact of a simple evidence-based~     protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a~     scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood~     transfusion when necessary. It is hypothesized that the protocol will significantly decrease~     in-hospital mortality in patients with severe sepsis.~   "
161669|NCT01449903|"~     The purpose of this study is to compare three different core build-up materials for dental~     use. The study hypothesis is that there is no differences in survival rate of the different~     core build-ups.~   "
161670|NCT01449890|"~     The primary objective of this study is to test in a randomized effectiveness trial if e-mail~     delivered cognitive behavioural treatment is an effective follow-up care approach in the~     treatment of depression under clinically representative conditions.~   "
161671|NCT01449877|"~     The investigators study aims to determine the effect of prophylactic therapy with~     Trimethoprim-sulfamethoxazole on the recurrences of toxoplasma retinochoroiditis gondii. This~     is a randomized, double-masked, in patients with eye condition of acute Toxoplasma gondii~     retinochoroiditis. Volunteers will be recruited with a previous diagnosis of chorioretinitis~     presumed Toxoplasma gondii, which show active lesions compatible with recurrence. After the~     acute phase of treatment of all patients [1 tablet Trimethoprim-sulfamethoxazole (800/160mg)~     12/12h during 45 days], the same Stratified by gender) will be randomized in a 1:1 ratio~     between the group 1 - TMP-SMZ (prophylactic treatment with trimethoprim-sulfamethoxazole 1~     tablet every other day for 311 days) or group 2 - placebo (consisting of a placebo pill~     containing no active ingredient of similar appearance to trimethoprim-sulfamethoxazole, 1~     tablet every other day for 311 days). The primary outcomes are incidence of episodes of~     recurrent chorioretinitis by toxoplasmosis in the follow up of 12, 36, 48, 60, 72, 84, 96,~     108, and 120 months. Patients will be followed during the ten years in uveitis clinic at~     intervals defined as follows: return weekly for 4 weeks, then monthly for 2 months, then each~     3 months for 9 months, and finally annually for 10 years.~   "
161672|NCT01449864|"~     The primary objectives are to determine feasibility and the acute toxicity profile of proton~     therapy with concurrent continuous infusion 5-FU chemotherapy. Secondary objectives are to~     determine late toxicities and to generate preliminary data on clinical efficacy.~   "
161673|NCT01449838|"~     This is a clinical study protocol for a single centre, randomized, double blind, placebo~     controlled, single and repeat dose study to investigate the safety, tolerability and~     pharmacokinetics of intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in~     healthy Japanese male subjects.~      Eighteen subjects will receive CMS-Na 2.5mg/kg (as colistin activity or 75,000 IU/kg) or~     placebo as a single dose and twice daily for 2.5 days by intravenous infusion.~      Blood and urine samples for pharmacokinetics analysis will be taken at regular intervals~     after dosing. Safety will be assessed by measurement of vital signs, Echocardiogram (ECGs),~     safety laboratory data, renal function and review of adverse events.~   "
161718|NCT01449253|"~     This is an open label, randomized, interventional study indented to find the efficacy of~     different treatment regimens in treatment of pulmonary hypertension secondary to lung disease~     and/or hypoxia.This is to find out when to start combination therapy (sildenafil plus~     bosentan) in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.~   "
166431|NCT01387269|"~     The administration of Anamorelin in patients with Stage III-IV non-small cell lung~     cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and~     muscle strength.~   "
161674|NCT01449825|"~     Pazopanib is approved by the FDA and EMA as targeted therapy for the indication of advanced~     renal cell carcinoma (RCC). Hepatic safety events were observed in the pazopanib pivotal~     clinical trial and the U.S. pazopanib label information contains a 'black box warning'~     regarding hepatotoxicity. These clinical observations have prompted GSK to undertake a~     proactive pharmacovigilance strategy focused on hepatic safety that goes beyond spontaneous~     reporting of adverse events.~      The goals of the study are to assess prescriber compliance with pazopanib label guidelines~     for liver monitoring among patients with RCC, as well as to quantify and characterize the~     hepatic safety profile of the product in real-world clinical practice compared to other~     anti-vascular endothelial growth factor (anti-VEGF) drugs. As part of regulatory commitments,~     GSK will conduct parallel epidemiologic analyses in different patient populations as~     represented in multiple databases of electronic medical records. To enhance accrual of data,~     GSK will conduct this safety surveillance program simultaneously across datasets in order to~     detect and characterize all cases of liver enzyme elevations in diverse populations of~     patients receiving pazopanib. Two additional goals of this study are to evaluate the~     incidence of cases of combinations of liver enzyme elevations indicative of Hy's Law and~     drug-induced acute liver failure among users of pazopanib compared to users of other~     anti-VEGF drugs. This research effort will be coordinated by an external coordinating center.~      An epidemiologic cohort study design, nested in several databases of electronic medical~     information, will be employed for the research questions. Following the availability of~     pazopanib in the relevant medical care system, the study will collect retrospective data at~     regular intervals over the course of four years among persons exposed to pazopanib and other~     anti-VEGF agents. Each patient will be characterized based on additional available~     information in the database (e.g., demographics, concomitant medications). Elevations in~     liver enzymes will be identified through laboratory data captured in these databases.~     Potential Hy's Law and acute liver failure cases will be identified through established~     screening criteria, and screen-positive cases will be reviewed by an adjudication committee~     of hepatologists for final determination of drug-associated causality.~   "
161675|NCT01449812|"~     The purpose of this booster study is to evaluate the immune persistence in healthy Chinese~     subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib)~     vaccine. The study will also evaluate the safety and immune response of these subjects to a~     booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT01086423).~   "
161676|NCT01449799|"~     In the current study GSK961081 and fluticasone propionate will be administered in a blended~     formulation from a single device and compared with GSK961081 and fluticasone propionate~     administered alone and concurrently. This is a single centre, randomized, double-blind,~     double dummy, single dose, four way cross-over study investigating the pharmacokinetics and~     pharmacodynamics of GSK961081 and fluticasone propionate when administered alone,~     concurrently and as a combination blend in healthy subjects.~   "
161677|NCT01449786|"~     More than 70% of birch pollen allergic patients suffer from allergic reactions to certain~     foods, e.g. stone fruits, hazelnut and some vegetables. However, specific immunotherapy (SIT)~     with birch pollen extract is not effective for the treatment of associated food allergy in a~     substantial number of patients. Based on our previous clinical and immunological~     investigations of birch pollen related food allergy (BPRFA) the investigators hypothesize~     that for effective SIT of this abundant food allergy the disease-eliciting food allergens~     should be employed. To prove this concept, the investigators aim to sublingually administer~     the major apple allergen, Mal d 1, to birch pollen-allergic patients with concomitant apple~     allergy and evaluate clinical and immunological effects of this treatment. The investigators~     choose Mal d 1 as model food allergen because (i) its cross-reactivity with Bet v 1 has been~     well characterized,(ii) apple is the most frequent trigger for BPRFA and (iii)~     recombinant(r)Mal d 1 was well tolerated after sublingual administration to 20 birch~     pollen-allergic patients in a previous study. Sublingual administration of a defined~     concentration of GMP-rMal d 1 will be compared with equal doses of GMP-rBet v 1 as a positive~     control and placebo-treatment. Clinical parameters will include skin prick tests (SPT) and~     objective and subjective assessment of apple and birch pollen-induced allergic symptoms.~     Immunological parameters will comprise the analysis of antibody and T cell responses to Mal d~     1 and Bet v 1 as well as the evaluation of basophil activation.~      The proposed pilot study will be a first investigation of the concept to specifically treat~     BPRFA with the involved food allergens and thus, represents an important step in the~     development of an efficient and safe therapy in the future.~   "
161678|NCT01449773|"~     The overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in patients~     with type 2 diabetes are now thought to be attributable to elevated intestinal production and~     reduced clearance. Substantial evidence exists indicating that elevated plasma levels of~     these lipoproteins are associated with increased cardiovascular disease risk. Therefore,~     reduction of atherogenic plasma triglyceride-rich lipoproteins (TRL) levels of intestinal~     origin appears to be crucial to improve CVD risk associated with type 2 diabetes. In this~     regard, n-3 PUFAs have been shown to exert beneficial effects on diabetic dyslipidemia.~     However, the investigators understanding of the physiological changes that occur with n-3~     PUFA supplementation is suboptimal, thereby limiting the investigators appreciation of its~     impact on CVD risk associated with type 2 diabetes. The effects of n-3 PUFAs on the~     intestinal production of TRLs and the expression of genes regulating intestinal lipid~     absorption and chylomicron synthesis have not yet been examined in humans. The general~     objective of the proposed research is to investigate the mechanisms by which n-3 PUFAs~     beneficially modify intestinal lipoprotein metabolism in patients with type 2 diabetes. The~     investigators hypothesize that n-3 PUFA supplementation in men with type 2 diabetes will:~        -  reduce TRL apoB-48 production rate and increase fractional catabolic rate of these~          lipoproteins,~        -  decrease the expression of genes that regulate intestinal lipid absorption and synthesis~          as well as synthesis of apoB-48-containing lipoproteins,~        -  decrease both plasma surrogates of cholesterol absorption and cholesterol synthesis.~   "
161695|NCT01449552|"~     Total knee arthroplasty (TKA) may be associated with significant blood loss, and transfusion~     carries substantial risk of immunologic reaction and disease transmission. Several methods~     reportedly reduce postoperative blood loss and avoid homologous blood transfusion with~     traditional TKA approaches. Drain clamping was one of the widely used method and tranexamic~     acid administration was the recently adjuvant method to reduce blood loss in TKA. However,~     there were several regimens in either drain clamping or tranexamic acid administration~     reported in previous studies. Our objective was to compare the efficacy of our drain clamping~     protocol and/or tranexamic acid regimen for reducing blood loss and transfusion in TKA.~   "
161696|NCT01449539|"~     The purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen therapy~     (HBOT) as a therapeutic option in mobilizing stem cells for autologous stem cell transplant.~   "
161679|NCT01449760|"~     Physical activity and in particular sport is beneficial to health. Nevertheless, some of~     these activities may create a risk of injury. Ankle sprain is the most common sport related~     injury. Sports that are causing the highest number of ankle sprains are: football (30%),~     handball-basketball-volleyball-rugby (24%), gymnastics sports (6%), skiing (6%), cycling~     (6%), athletics (4%) and contact sports (4%). A recent study in the Netherlands identified a~     total of 1.3 million sports injuries. 47% of these patients required medical care. The total~     costs (direct and indirect) were assessed 84.240.000 EUR per year.~      Prospective studies demonstrated that athletes with a ankle sprain have a twofold risk of~     re-injury during the first year after the trauma, and in half of patients with an ankle~     sprain recurrence this could lead to instability or chronic pain of the ankle.~      The Wii Balance Board ® is a tool that is increasingly used in the field of health. In some~     hospitals, therapists are beginning to use it for the rehabilitation of patients after~     surgery, fractures or strokes.~      Patients are asked to complete their physical therapy session by practicing sports via~     video games such as skiing, bowling or hula hoop. Currently, there are no randomized~     controlled studies that publish on the effectiveness of this tool. Recently, a study~     investigated the efficacy of the Wii Balance Board ® to improve balance, strength, joint~     mobility and level of physical activity. After 10 weeks of training, people an increased~     strength and balance was found. However, these results still require statistical~     confirmation. Thus this objectives of this study are~        -  To assess the efficacy of exercise training with the Wii Balance Board ® Platform~        -  To evaluate the effectiveness of physical therapy (based on current guidelines)~        -  To compare these two types of care (conventional physiotherapy versus Wii) to a control~          group (non-treatment).~   "
161680|NCT01449747|"~     The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor~     in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4~     inhibitor~   "
161681|NCT01449734|"~     There is increasing awareness that high-quality care in the intensive care unit also includes~     care of visiting family members according to their needs. The investigators therefore want to~     assess family satisfaction using a questionnaire that was specially developed for this~     setting and recently validated for German-speaking participants.~   "
161682|NCT01449721|"~     The purpose of this study is to assess the ability of an empiric resuscitation strategy~     compared to standard care to decrease the incidence of organ failure in normotensive sepsis~     patients.~   "
161683|NCT01449708|"~     Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after~     surgery and general anesthesia. The results of our observational study indicate that 42.7% of~     patients require medication to treat PONV in the first 24 hours after bariatric surgery~     despite our aggressive perioperative approach with triple prophylaxis. Common risk factors~     for PONV are the use of intraoperative narcotics and anesthetic gases.~      Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a~     reduction of narcotic consumption, desaturations and use of antiemetic medication.~      Our study hypothesis is that different types of anesthetics reduce PONV further.~      Patient would be randomly assigned to receive either our current intraoperative management or~     a narcotic free, total intravenous general anesthetic (TIVA).~      The investigators hope to improve patients' satisfaction by reducing PONV in the~     postoperative period.~   "
161684|NCT01449695|"~     The purpose of this study is to investigate whether a nurse-based intervention, consisting of~     structural informative consulting and motivational counseling, on top of usual care with or~     without personalized web-based visualization of cardiovascular risk levels, improves the~     medication adherence in high risk cardiovascular patients.~   "
161685|NCT01449682|"~     To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular~     function and recalcitrant macular edema associated with retinal vein occlusion following~     treatment with 2 or more prior intravitreal anti-VEGF drug injections.~   "
161686|NCT01449669|"~     The purpose of this study is to investigate the pharmacokinetics of cefazolin using both~     plasma and microdialysate sampling methods in children with single ventricle physiology~     undergoing their second palliation procedure. This will provide data to determine if the~     current standard dosing regimen of cefazolin is adequate to achieve and maintain tissue~     concentrations greater than the minimum inhibitory concentrations (MIC) for common~     post-surgical pathogens that cause Surgical Site Infections (SSIs).~   "
161687|NCT01449656|"~     The aim of this randomized prospective study is to compare two laryngeal mask airways with a~     provision for evacuation of gastric contents, the LMA Proseal and The investigators~     hypothesize that airway leak pressures with the LMA Proseal will be significantly different~     (higher) when compared with the LMA Supreme.~   "
161688|NCT01449643|"~     The purpose of this study is whether an inspiratory muscle training protocol would be~     associated with an improvement in of the diaphragm mobility, an increase in pulmonary~     function values , gain strength and endurance of respiratory muscles and improving quality of~     life.~   "
161689|NCT01449630|"~     This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to~     look at safety, how well the study drug is tolerated, and how much of the study drug gets~     into the blood stream and how long it takes the body to get rid of it when given to humans.~     Information about any side effects that may occur will also be collected. Subjects will~     participate in the study for approximately 3 months. This study is for research purposes only~     and is not intended to treat any medical condition.~   "
161690|NCT01449617|"~     A carotid stenosis is treated with invasive procedures of revascularization when the lumen is~     reduced by more than 70% or when the lumen is reduced by more than 50% in patients who have~     had symptoms attributable to the affected carotid district in last the 6 months.~      Two options for the treatment of patients with carotid stenosis exist currently: the~     traditional surgical intervention of removal of the plaque by carotid endoarterectomy~     (CEA)and percutaneous transluminal carotid angioplasty with a balloon associated to the~     positioning of a stent through a catheter brought directly in the carotid artery (CAS).~      The main complication of both the procedures is early thrombosis, a phenomenon in which~     platelets play a central role. The importance of an effective inhibition of platelet~     activation in these patients has been widely demonstrated.~      Clinical studies in patients undergoing PTCA have demonstrated that the optimal treatment for~     the prevention of stent thrombosis is a dual antiplatelet regimen with aspirin plus~     clopidogrel, as compared with the single drugs. Given that no specific clinical trial has~     assessed the best antiplatelet therapeutic regimen in CAS with stenting, by extension from~     these findings in ischemic heart disease CAS patients are treated with aspirin plus~     clopidogrel.~      Several studies have demonstrated that an elevated residual platelet reactivity despite~     treatment with clopidogrel is associated to an increased risk of major adverse cardiovascular~     events (MACE) after stenting for coronary disease.~      No data are instead available on the possible predictive value of residual platelet~     reactivity for the incidence of ischemic cardiovascular events in patients with~     atherosclerotic carotid disease undergoing CAS with stenting.~      Aim of the study will be to assess the predictive value of residual platelet reactivity, as~     measured by different laboratory tests in patients undergoing CAS with stenting and treated~     with aspirin plus clopidogrel, for the incidence of cardiovascular complications (major~     adverse ischemic events).~   "
161691|NCT01449604|"~     The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and~     stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).~   "
161692|NCT01449591|"~     This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of~     treatment as compared to an active control and vehicle in patients with~     erythemato-telangiectatic rosacea.~   "
161700|NCT01449487|"~     Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder characterized by chronic~     abdominal pain and altered bowel habits in the absence of any organic cause. Patients with~     IBS visit the doctor more frequently, use more diagnostic tests, consume more medications,~     miss more workdays, and consume more overall direct costs than patients without IBS. More~     specific treatment of the localized symptoms of IBS is therefore needed, why the present~     study will investigate the effect and mechanisms of PPC-5650. PPC-5650 is a new chemical~     entity that can negatively modulate the activity of Acid sensing ion channels (ASICs). It is~     a potent low molecular weight inhibitor for this class of ion channels described to date.~      It is hypothesized that safety, efficacy and mechanisms of local administration in the rectum~     of PPC-5650 can be evaluated by use of experimental induced sensation and pain in the rectum.~   "
161701|NCT01449474|"~     Total knee arthroplasty (TKA) is the common and effective procedure for treatment of~     end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important~     factors which effects on survival of prosthesis. High percentage of misalignment has been~     reported in conventional technique with using the jig based instruments. Several methods and~     devices were established to solve this problem. Customized or patient matched instruments~     were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With~     using special software to calculate the alignment axis, it was thought that accurate~     alignment can be achieved by using this instruments. Therefore, the study aimed to compare~     the accuracy of MRI based patient matched instruments and jig based instruments in TKA.~   "
161702|NCT01449461|"~     The purpose of this study is 2-fold: initially, in the dose escalation phase, the goal is to~     determine the safety profile of orally administered brigatinib, including: the maximum~     tolerated dose (MTD), dose limiting toxicities (DLTs), recommended phase 2 dose (RP2D), and~     pharmacokinetic (PK) profile. Then, once the RP2D is established, an expansion phase will~     assess the preliminary anti-tumor activity of brigatinib, both in non-small cell lung cancer~     (NSCLC) with ALK gene rearrangement (including participants with active brain metastases) or~     mutated EGFR, and in other cancers with abnormal targets against which brigatinib is active.~   "
161703|NCT01449448|"~     Injection with corticosteroid is one of the most common non-operative interventions in the~     treatment of subacromial impingement; however, its use is limited by its potential side~     effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). The~     objective of this study was to compare the efficacy of subacromial injection of triamcinolone~     compared to injection of ketorolac. Thirty-two patients diagnosed with external shoulder~     impingement syndrome were included in this double-blinded randomized controlled clinical~     trial. Each patient was randomized into the Steroid group or NSAID group.~   "
161704|NCT01449435|"~     The purpose of this study is to determine whether parameters of the pulmonary function tests~     and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.~   "
161705|NCT01449422|"~     The main objective of this trial is to demonstrate that a local care strategy using URGO 310~     3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing~     in the management of venous ulcers. This non-inferiority hypothesis will be judged on the~     planimetric relative regression of the wound surface area after six weeks of treatment.~   "
161706|NCT01449409|"~     The purpose of Reduce IDentified UNcontrolled Asthma (RIDUNA) is to determine the benefit of~     real-time identification of uncontrolled asthma by electronic administrative records linked~     to real-time notification of uncontrolled status to patients and asthma specialists with~     recommended guideline directed intervention by physicians. The investigators hypothesize that~     real-time outreach following National guideline asthma care recommendations, after real-time~     identification of an uncontrolled asthma event in persistent asthmatics on inhaled~     corticosteroids will lead to better improvements in asthma control (impairment and risk)~     compared to standard asthma care outreach.~   "
161707|NCT01449396|"~     The aim of the study is to prove that acupuncture applied before and after embryo transfer is~     able to increase pregnancy rates by means of reducing stress and improving endometrial~     vascularization in women receiving in vitro Fertilization (IVF) treatments.~   "
161708|NCT01449383|"~     This study aims to investigate the direct effect of high amounts of dietary fibre and high~     amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers~     in healthy adults.~   "
161709|NCT01449370|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal~     biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when~     administered orally in subjects with advanced solid malignancies.~   "
161710|NCT01449357|"~     A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients~     with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine~     Kinase Inhibitors.~   "
161711|NCT01449344|"~     The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose~     ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with~     relapsed or refractory mantle cell lymphoma.~   "
161712|NCT01449331|"~     The purpose of this study is:~        -  to estimate the frequency of the use of non invasive ventilation~        -  to estimate the frequency of the use of palliative non invasive ventilation~        -  to evaluate the impact of non invasive ventilation~        -  to propose some recommendations~   "
161713|NCT01449318|"~     The purpose of the study is to prove that pain scores generated from painful stimuli applied~     preoperatively may help identify the inter-individual variability in pain perception.~   "
161714|NCT01449305|"~     To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline~     after wearing Nanoone Woman Underwear in women with primary dysmenorrhea~   "
161715|NCT01449292|"~     The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System~     treatment plus optimal medical therapy compared in patients with advanced upper lobe~     predominant (ULP) heterogeneous emphysema.~   "
161716|NCT01449279|"~     To determine the safety of local palliative radiation therapy used in combination with~     anti-CTLA-4 immunotherapy.~   "
161717|NCT01449266|"~     To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients~     with chronic renal failure who require hemodialysis treatment.~   "
161719|NCT01449240|"~     The purpose of the study is to collect data on CSF biomarkers in patients with Hunter~     Syndrome that would serve as reference data for comparison with cognitively impaired patients~     with Hunter syndrome, patients with other lysosomal storage diseases, or other diseases with~     CNS involvement.~   "
161720|NCT01449227|"~     The purpose of this prospective study is to see the natural course of adhesive capsulitis of~     hip. The study is based on the hypothesis that the natural course of adhesive capsulitis of~     hip is similar to that of adhesive capsulitis of shoulder. This study is also based on a~     hypothesis that hip joint capsule stretching exercise will result in pain relief, recovery of~     hip range of motion in months.~   "
161721|NCT01449214|"~     Thoracic epidural analgesia and anesthesia are effective in improving the quality of~     intraoperative and postoperative pain relief during thoracic and abdominal surgical~     procedures. Conventional epidural techniques have significant limitations. Due to the~     anatomic characteristics of the thoracic versus the lumbar intervertebral spaces, the~     insertion requires a more technically challenging paramedian approach. The safety and~     feasibility of bedside ultrasonography for the lumbar spine has already been established and~     it proves to be a valuable tool for neuraxial anesthesia in obstetric anesthesia~   "
161722|NCT01449201|"~     Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to~     poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor~     efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based~     irreversible pan-HER inhibitor. In preclinical studies, PF-00299804 has much lower IC50~     values than gefitinib in cell lines engineered to express EGFRvIII mutations (1.2 nM versus~     2,700 nM) and produces tumor growth inhibition in gefitinib-resistant xenografts. A phase II~     trial of PF-00299804 in patients with recurrent or metastatic HNSCC is currently ongoing and~     preliminary report in ASCO 2010 showed its anti-tumor activity against HNSCC. The~     investigators suggest a phase II trial of pan-HER inhibitor PF-00299804 in patients with~     recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.~   "
161723|NCT01449188|"~     Ondansetron, also known as Zofran, is a marketed compound used for the prevention of nausea~     and vomiting. This study, called a thorough QT study, will characterize the effects of a~     single intravenous (IV) dose of ondansetron on cardiac repolarization as compared to placebo.~     Moxifloxacin, a commercially available antibiotic known to cause a mild QT prolongation, will~     be used as a positive control and will be given orally. The cardiac repolarization will be~     measured by taking consecutive ECGs on a recording device known as a Holter monitor and~     measuring the QT interval at specified times. In addition, blood samples will also be taken~     at specified times and will be used to measure the amount of study medication in the body.~   "
161724|NCT01449175|"~     The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long~     term safety and efficacy information about the AeriSeal System treatment in patients with~     advanced emphysema.~   "
161725|NCT01449162|"~     The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day~     versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral~     corticosteroids.~   "
161726|NCT01449149|"~     The objectives of this study are 1) To evaluate the feasibility and acute side effects of~     proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and~     long term side effects of proton beam radiation for treatment of chordomas and~     chondrosarcomas.~   "
161727|NCT01449136|"~     Dental materials with antibacterial properties can prevent the harmful effects caused by oral~     cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of~     antibacterial cement for sealing infected dentin in atraumatic restorations of primary~     molars.~   "
161728|NCT01449123|"~     The primary objective in this pilot study is to explore if asthma patients prescribed fixed~     dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®),~     beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge~     test and the following reversibility test.~      The primary endpoint is to identify asthma patients responding positive or negative to the~     mannitol challenge test and/or the reversibility test.~      The hypothesis is that not all patients are well treated.~   "
161729|NCT01449110|"~     Resveratrol can exhibit benefits against cardiovascular diseases (CVDs) although the~     cardioprotective role of resveratrol as part of the human diet is not yet clear.~      The aim of this trial is to evaluate the safety and efficacy of a resveratrol-enriched grape~     extract (Stilvid) in 150 patients from both primary and secondary cardiovascular prevention.~      All the patients are gold-standard medicated (statins and others). A number of cardiovascular~     risk and safety markers will be evaluated after consuming 1 cap/day for 6 months and 2~     caps/day for 6 additional months (total 12 months).~   "
161730|NCT01449097|"~     The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus~     the femoral nerve block versus placebo on muscle strength in healthy volunteers. The~     investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of~     the quadriceps muscle strength compared to the femoral nerve block.~   "
161731|NCT01449084|"~     Temporary pancreatic duct stent placement during endoscopic retrograde~     cholangiopancreatography (ERCP) has been recommended for post-endoscopic pancreatitis (PEP)~     prophylaxis in high risk patients, including those in whom accidental pancreatic duct~     cannulation has occurred. However, the optimal duration of stent placement remains an open~     question. The investigators aim is to assess if immediate stent removal is effective in the~     prevention of PEP after accidental pancreatic duct cannulation.~   "
161732|NCT01449071|"~     The primary objective of the study is to evaluate the safety, tolerability and~     Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE~     as add on to standard of care treatment during the trial.~   "
161743|NCT01448915|"~     The principal goal of this research project is to evaluate the natural history of HCV and~     liver disease and its treatment in HIV-infected persons who use drugs. Research procedures~     will focus on determining liver disease prevalence and severity within this population. This~     is an observational study without study specific interventions.~   "
162060|NCT01444625|"~     As flavanols have antioxidants, anti-inflammatory and anti-DNA damaging effects and may~     increase microcirculation in skin, the purpose of the study is to investigate the chronic~     effect of flavanol-rich chocolate as an effective strategy to protect against the harmful~     effect of ultraviolet (UV) radiation.~   "
161733|NCT01449058|"~     This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum~     tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally~     administered combination of BYL719 and MEK162. This combination will be explored in adult~     patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or~     other advanced solid tumors and in adult patients with AML or high risk and very high risk~     MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian~     logistic regression model with overdose control. At MTD or RDE, four expansion arms will be~     opened in order to further assess the safety and preliminary activity of the combination of~     BYL719 and MEK162 in specific patient populations.~   "
161734|NCT01449045|"~     Malaria is a major public health problem. 250 million cases annually leads to approximately 1~     million deaths. Over 80 per cent of these deaths occur among African children under age five.~     The main interventions covered treatment with Artemisinin Combination Therapies (ACT), long~     lasting bednets distribution and Rapid Diagnosis Tests (RDT) to improve malaria diagnosis.~     This has led in Senegal to a substantial decrease in the incidence of malaria, in 2009.~     However the recent overall decline hides the fact that malaria incidence remains very high in~     the south of Senegal. That's why Home-based management (HMM) for malaria is being introduced~     in selected areas. Intermittent Preventive Treatment (IPT) by monthly administration of a~     therapeutic dose of antimalarials can achieve a very high degree of protection from attacks~     of clinical malaria in children. The purpose of this project is to evaluate the effectiveness~     of combining IPTc with HMM in southern Senegal~      The study objectives are to :~        -  Assess the tolerance of IPTc using SP+AQ when it is administered for a longer period in~          areas with a longer transmission season,~        -  Assess the added benefit that IPT with the association of Sulfadoxine-Pyrimethamine +~          Amodiaquine can offer in populations where a rapid and early care with home management~          of malaria is already established.~        -  Determine the cost benefit ratio of the addition of IPTc with HMM. A cluster randomized~          controlled trial has been designed to evaluate the effectiveness of adding seasonal IPTc~          with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) for 5 months per year, in~          villages where home-based management of malaria is implemented. All villages in Saraya~          district, excluding 7 villages with a health post, will be eligible to participate.~          Saraya villages will be combined to form 24 clusters which will be randomized to receive~          HMM from a community volunteer, or IPTc plus HMM. Trained volunteer Community Medicine~          Distributors (CMD) will provide HMM. The primary endpoint will be the incidence of~          clinical malaria with fever or history of fever and parasitaemia with density of at~          least 3000/ul. Secondary outcomes will include the safety, the tolerability, the~          coverage and acceptability of the intervention. Both the recurrent and capital costs to~          the health service of training staff and delivering the interventions will be estimated.~          Both direct and indirect costs to users of the services (children and their families)~          will also be assessed.~   "
161735|NCT01449032|"~     Coronary artery disease (CAD) is the most common cause of death and a major cause of hospital~     admissions for acute chest pain. In spite of improved treatments still many patients with CAD~     have daily attacks of severe chest pain and severely reduced life quality.~      The investigators have established a double-blind placebo-controlled trial in patients with~     CAD to test efficacy and safety of treatment with adipose derived stem cells to improve~     perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.~   "
161736|NCT01449019|"~     The purpose of the study is to determine the contribution of endogenous Glucagon-like peptide~     1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin effect in~     healthy subjects and patients with type 2 diabetes mellitus (T2DM).~   "
161737|NCT01449006|"~     HIV related cognitive impairment still occurs despite highly active antiretroviral therapy~     (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease;~     leading to varying degrees of cognitive impairment, recently termed HIV associated~     neurocognitive disorders (HAND). HAND may occur in patients who are virally suppressed in~     both blood and CSF.~      Patients with HIV Associated Neurocognitive Disorders (HAND) who are virally suppressed in~     both their blood and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral~     therapy (HAART) regimen may have significant cognitive improvement with HAART intensification~     with the medication Maraviroc; compared to those who remain on their existing regimen.~      This study will be a prospective, interventional, randomised and unblinded controlled~     clinical trial. The aim of this study will be to determine whether HAART intensification with~     the medication Maraviroc, leads to significant improvement in HIV associated neurocognitive~     disorders (HAND).~      Patients with the recent progression (within 6 months) of HAND (validated by~     neuropsychological assessment) on HAART, who are virally suppressed (<50 copies per ml) in~     blood and CSF will be randomised to have their existing HAART regimen intensified with~     Maraviroc, or not. The control arm will remain on their medication regimen as prescribed. The~     target is to enrol 70 patients into the control group, and 70 patients into the Maraviroc~     intensification group.~      Patients will undergo baseline neuropsychological testing, MRI, blood tests, and~     cerebrospinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the~     effectiveness of adding Maraviroc, will include further neuropsychological assessment at 6~     months, and neuropsychological assessment, MRI and CSF assessment again at 12 months.~      Neuropsychological testing completed at 6 and 12 months will be completed by a blind~     assessor, in that they will have no knowledge of which arm (treatment or control) the~     participant is enrolled in.~      An evaluation (neuropsychological testing) will be performed should the patient deteriorate~     during the course of the study, as recognised by the patient's managing physician.~      At the end of the study protocol (12 months) the patient's HAART therapy will be managed by~     their primary physician.~   "
161738|NCT01448993|"~     Patients with difficulty in swallowing (dysphagia) or with reflux disease are frequently~     found to suffer from oesophageal hypomotility (weak contractions).~      Oesophageal motility is currently measured using high-resolution manometry (HRM). This~     technique has a 36 pressure sensors on a plastic tube to record the pressure in side the~     oesophagus.~      Several pharmaceutical agents (prokinetics) can stimulate oesophageal motility. However, use~     of prokinetics in patients with oesophageal hypomotility led to disappointing results. An~     explanation for these disappointing results is that inappropriate patients were targeted. The~     appropriate patient would be the one who still have some viable muscle in the oesophagus that~     can respond to pharmacological stimuli.~      In the process of developing treatment strategies in patients with oesophageal hypomotility,~     testing the preserved capacity of oesophageal muscles could be useful to predict the response~     of these patients to prokinetic drugs. The following tests have the potential to reveal the~     preserved capacity of the oesophageal muscle to respond to stronger/medicinal stimuli.~        1. - Multiple rapid swallowing (MRS) of 5ml water boluses stimulates oesophagus. A normal~          response to MRS requires on the one hand integrity of neural mechanisms and on the other~          hand a functional oesophageal muscle.~        2. - External abdominal compression can increase the resistance to bolus transport via~          oesophagus. The normal oesophagus produces contractions of higher amplitude and duration~          in order to maintain a normal bolus transit.~        3. - Swallowing bread boluses require stronger oesophageal contractions for a successful~          bolus transit.~      The purpose of the proposed project is to firstly assess the effect of Azithromycin on~     oesophageal hypomotility and secondly to evaluate the predictive values of the stimulation~     techniques in predicting the likelihood the positive response to drug therapy.~   "
161739|NCT01448980|"~     Stroke is one of the common diseases in the elderly. It is the third ranking cause of death~     and affects health care system in our country. One of the most important consequences of~     stroke is spasticity. Some stroke patients suffered from severe spasticity or hypersensitive~     reflex to stimuli. It can cause contracture, limit self care function, transfer or~     ambulation. Most of stroke patients have to depend on their relatives or families.~   "
161740|NCT01448954|"~     This study is to examine the safety, tolerability, pharmacokinetics and functional activity~     of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic~     asthma.~   "
161741|NCT01448941|"~     The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular~     bridge plate fixation of the same joint in acute Lisfranc injuries.~   "
161742|NCT01448928|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Zevalin for relapsed or~     refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The~     objective of this study is to assess safety and efficacy of using Zevalin in clinical~     practice. This study is also all case investigation of which the enrollment period is five~     years, and all patients who received Zevalin will be recruited and followed 13 weeks after~     the administration.~   "
161744|NCT01448902|"~     The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to~     placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a~     randomised, double blind, placebo controlled, two way crossover evaluation. There will be a~     screening period of up to three weeks and a washout period of at least one week between the~     two treatment periods. There will be a follow up one to three weeks after the last dose of~     study drug.~   "
161745|NCT01448889|"~     Acute renal failure induced by radiographic contrast agents is a known complication of~     coronary angiography.hypoxia plays a major role in the pathogenesis of Contrast induced~     nephropathy.~      The aim of the current study is to investigate the effect of normobaric hyperoxygenation~     therapy on renal functions in patients at high risk for CIN undergoing coronary angiography.~      The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD~     equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary~     angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated~     congestive heart failure, hemodynamic instability, known sensitivity to contrast media and~     patients who had been exposed to contrast media during the last 3 months will be excluded.~     Patients with oxygen blood saturation of less than 94% at room air will also be excluded from~     the study.~      Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask~     (treated group) or breath room air (control group) for duration of 4 hours starting at the~     beginning of the angiographic procedure.~      All patients will be treated with 0.9% salin and NAC. Coronary angiography will be performed~     using nonionic, low osmolar iodine (Ultravist®-370) (Schering, Berlin, Germany).~      All patients will be hospitalized 1 day before and at least 24 hours following angiography.~     Blood samples for urea, creatinine and cystatin- C will be drawn on admission, 6, 24 and 48~     hours after coronary angiography. Urine sample will be taken 24 hours before angiography and~     6, 24 and 48 hours post angiography. In those urine samples the ratio between creatinine to~     Isoprostanes and NO will be evaluated.~   "
161746|NCT01448876|"~     Objective was to understand the dynamics of Chlamydia trachomatis (Ct) detection by nucleic~     acid amplification testing (NAAT) after treatment and consequences for test-of-cure practice.~   "
161747|NCT01448863|"~     The present study aims to elucidate if there is a metabolomic profile alteration in the~     embryos of obese women in order to understand if the reduced implantation rate observed in~     these patients is directly related to this factor. Furthermore, the investigators seek to~     establish if there is any difference between obese women with Polycystic Ovary Syndrome (PCO)~     and without PCO. The investigators compare these metabolomic profile embryos with embryos of~     egg-donation programme.~   "
161748|NCT01448850|"~     The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or~     severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult~     subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic~     Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the~     underlying disease condition.~   "
161749|NCT01448837|"~     The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to~     compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed~     combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan)~     administered once in the evening (20:00) in newly-diagnosed patients with exfoliation~     syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated~     and IOP greater than 29 mm Hg.~   "
161750|NCT01448824|"~     This is a 2-part study. Part 1 is to determine the safety and tolerability in healthy~     subjects of increasing daily doses of LY2484595 for 14 days to achieve a blood level of~     LY2484595 much higher than what is needed for therapy. The amount of study drug that reaches~     the bloodstream and the time it takes for the body to get rid of it will be determined. The~     effect of the study drug on factors in the blood related to cholesterol will be measured.~      Part 2 is to determine how ketoconazole affects how much of the study drug, LY2484595, gets~     into the bloodstream and how long it takes to get rid of it.~      Information about any side effects that may occur will also be collected.~   "
161751|NCT01448811|"~     To compare the difference of sedation monitoring for bronchoscopic examination monitoring by~     auditory evoked potentials (AEP) or Ramsay Sedation Scale (RSS) in mechanical ventilated~     patients.~   "
161752|NCT01448798|"~     The purpose of this study is to evaluate the use of a hemostatic gelatine-thrombin matrix~     during athermal nerve-sparing prostate resection compared to conventional hemostasis using~     electrocautery in patients with localized prostate cancer and to investigate effects on~     postoperative erectile function and continence.~   "
161753|NCT01448785|"~     The main objective of this post-market surveillance study is to compare the subject's weight~     loss and quality of life, and device safety performance of the abiliti System and the~     adjustable gastric banding therapies in obese to morbidly obese subjects.~   "
161754|NCT01448772|"~     This is a comparative study to assess bioavailability of a proposed alternate dosage form~     against the current FDA-approved branded product.~   "
161755|NCT01448759|"~     The purpose of this study is to evaluate plasma alcohol concentration in patients receiving~     Paclitaxel or Docetaxel infusion.~   "
161756|NCT01448746|"~     This study is to define the optimal method of prophylaxis for patients with gastrectomy in~     Korea and the investigators hypothesized only mechanical method would be enough for~     preventing VTE on perioperative period.~   "
161757|NCT01448733|"~     The purpose of this study is to evaluate whether Cerave lotion followed by Acanya Gel in the~     morning in combination with Cerave lotion followed by Atralin gel in the evening is safe and~     effective for the treatment of acne vulgaris.~   "
161758|NCT01448720|"~     The purpose of this study is to explore the efficacy of paliperidone palmitate administered~     as a once monthly injection in patients with an acute exacerbation of schizophrenia.~   "
161759|NCT01448707|"~     The purpose of this study is to compare the efficacy, safety and tolerability of~     darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing~     darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors~     (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who~     have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral~     Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function~     will be compared throughout the study.~   "
161760|NCT01448694|"~     This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to~     apply feature extraction and machine learning techniques to non-invasive hemodynamic data to~     identify early signs of acute blood loss. The availability of this information may help to~     establish required interventions for treating trauma patients and battlefield casualties.~      Study hypothesis: Hemodynamic changes measured non-invasively during the blood donation~     process can be modeled to provide early estimations of blood loss.~   "
161761|NCT01448681|"~     There is statistically significant correlation between invasive measures of intracranial~     pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms~     to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow~     modeling for trend prediction of derived ICP information. Specific aims:~        1. Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic~          brain injury in humans.~        2. Predict and anticipate changes in ICP for preemptive management purposes.~        3. Analyze characteristics of changes in ICP after treatment failure.~        4. Analyze data to predict/anticipate confounding physiologic factors that affect ICP and~          its treatment.~        5. Test the resulting models in real time.~   "
161762|NCT01448668|"~     Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu~     (quercus, i.e. from oak tree) in patients with pancreatic cancer (Union for International~     Cancer Control, UICC stages II-IV), in addition to conventional oncological therapy (radio-,~     chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.~      Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy~     or disease induced symptoms (both are quality of life parameters and evaluated after 1 year);~     prolongation of disease free and/or overall survival (DFS, OS) after 3 years.~      Prospective observational confirmation study of previous retrospective cohort study.~      As this is a non-interventional cohort study, all therapies and measurements are performed on~     directive by the treating physician and/or request by the patient only.~   "
161763|NCT01448655|"~     Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu~     (quercus, i.e. from oak tree) in patients with colorectal cancer (Union for International~     Cancer Control, UICC stages II-IV), in addition to post-operative conventional oncological~     therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional~     therapy only.~      Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy~     or disease induced symptoms (both are quality of life parameters and evaluated after 1 year);~     prolongation of disease free and/or overall survival (DFS, OS) after 5 years.~      Prospective observational confirmation study of previous retrospective cohort study.~      As this is a non-interventional cohort study, all therapies and measurements are performed on~     directive by the treating physician and/or request by the patient only.~   "
161764|NCT01448642|"~     The purpose of this study is to determine whether a loading dose of atorvastatin before~     percutaneous intervention procedures in acute coronary syndromes is effective to reduce major~     cardiovascular events(MACE).~   "
161765|NCT01448629|"~     Introduction:~      It is not an illness to have an ostomy, even though it is an indication of previous serious~     illness, such as cancer, which is the reason for approximately 80% of all ostomy operations.~     Ostomies can be divided into three categories: colostomy (large intestine), ileostomy (small~     intestine) and urostomy (urinary tract). All require surgical redirection of the intestine or~     urinary tract, allowing for elimination of urine and faeces by means of an opening in the~     abdominal wall. For the population included in this study, subject with an ileostomy, colitis~     ulcerosa is the main cause for an ileostomy where a surgical removal of the colon and rectum~     resulting in an ileostomy in theory cures the disease.~      It can be very challenging to live with an ostomy and modern ostomy products should make life~     as easy as possible for people with ostomies.~      Leakage and peristomal skin problems have been found to have a negative effect on the quality~     of life for people with ostomies. The skin problems are the reason for one out of three~     visits to ostomy nurses and occur much more frequently in people who have had ileostomies~     than in those who have had colostomies. It has been observed that the prevalence of~     peristomal skin problems is 21-60% among people who have ileostomies, 13-35% among those who~     have colostomies and 21-48% among those who have urostomies.~      Leakage from ostomies that comes into contact with the skin is thought to predispose the~     patient to peristomal skin problems. One investigation of peristomal skin problems found that~     77% of cases were related to contact with faeces or urine.~      There are several reasons why leakage from an ostomy occurs, such as uneven peristomal area,~     improper handling of the ostomy product or a problematic ostomy (its formation, its location,~     retraction, prolapse or hernia). The ostomy may also change size with time, which can lead to~     leakage, if the ostomy products are not adapted accordingly. As a general rule, a check-up of~     the ostomy by an ostomy nurse or a doctor together with educational support can reduce these~     problems. Modern ostomy products should, however, also be constantly developed in order to~     lessen to the greatest extent possible the risk of leakage and associated inconveniences.~   "
161766|NCT01448616|"~     The investigators propose a randomized, double blind, placebo-controlled, cross-over trial to~     evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex~     virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human~     immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that tenofovir~     will reduce genital HSV shedding compared to placebo.~   "
161767|NCT01448603|"~     Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In~     the third National Health and Nutrition Examination Surveys54.3% of the population had~     positive test responses to one or more allergens, with the prevalence for short ragweed being~     26.2%~      The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis~     symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing~     visits and the post treatment challenge (PTC) visit in study TR002 approximately one year~     after the start of treatment.~   "
161768|NCT01448590|"~     Epidural anesthesia is associated with potential risks and complications, post dural puncture~     headache (PDPH) one of the most recognized with epidural or spinal anesthesia. Accidental~     dural punctures occur with approximately 1.5% of all epidural attempts. Studies have~     suggested that the use of an intrathecal catheter reduces the incidence of PDPH. A systematic~     review of the existing literature will identify if there is reliable evidence to support this~     theory. A secondary outcome, headache severity, will also be explored via incidence rates of~     epidural blood patch, as this intervention is performed as a treatment for the most severe~     headaches.~   "
161802|NCT01448148|"~     Memory interventions are training programs that provide a variety of cognitive and~     psychological strategies meant to improve memory. These interventions have been shown to~     yield significant benefits to normal aged persons and small-size studies have shown that they~     are suitable and beneficial for persons with mild cognitive impairment. The goal of this~     proposal is to assess with a well-controlled design the efficiency and specificity of~     cognitive training in persons with mild cognitive impairment.~      The hypothesis is that cognitive training can improve the cognition of persons with mild~     cognitive impairment and that this improvement can be enduring.~   "
161769|NCT01448577|"~     Lipoprotein lipase deficiency (LPLD) is an autosomal recessive inherited condition caused by~     homozygosity or compound heterozygosity for mutations within the LPL gene. LPLD results in~     subjects presenting with fasting plasma triglyceride (TG) levels of > 10 mmol/l. LPLD~     typically presents in infancy or childhood with usual complaints of severe abdominal pain,~     repetitive colicky pains and repeated episodes of acute pancreatitis The most severe clinical~     complication associated with LPLD is acute pancreatitis. Pancreatitis in an LPLD subject~     often leads to prolonged hospital admissions (sometimes up to weeks). Subjects who survive~     repeated episodes of acute pancreatitis may develop chronic pancreatitis, ultimately~     resulting in endocrine and exocrine pancreatic insufficiency.~      The clinical manifestations of acute pancreatitis episodes related to LPLD are largely~     indistinguishable from acute pancreatitis due to other causes. However, collection of data~     relating to hospital admissions, laboratory test results, scan images and adverse events~     occurring concomitantly to the acute pancreatic episode should allow elimination of other~     causes of pancreatitis (e.g gallstones etc) and ultimately allow confirmation of LPLD-related~     acute pancreatitis. Characterization of the presentation of symptoms which occur around the~     time of known episodes of LPLD-related acute pancreatitis should also permit identification~     of episodes of acute pancreatitis which have previously been considered as unrelated or even~     unrecognized.~      The objective of the study is to re-assess and re-confirm data previously recorded about the~     incidence and severity of acute abdominal pancreatitis episodes in LPLD subjects previously~     enrolled on AMT clinical studies. To assess and document the presentation of acute abdominal~     episodes that occur around known episodes of pancreatitis and to permit the identification of~     possible new previously unrecorded episodes of pancreatitis based upon predefined diagnostic~     criteria. The objective is to recruit the 27 subjects previously enrolled in the above~     mentioned clinical studies.~   "
161770|NCT01448564|"~     Light-emitting diodes (LEDs) have been used to minimize muscle fatigue in athletes and~     healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible~     to early muscle fatigue. The objective of this study is to assess the acute effects of LEDs~     on muscle function, exercise capacity, and cardiorespiratory responses during isometric and~     dynamic exercise in patients with COPD. This study will assess 30 patients with moderate to~     severe obstruction (FEV1 ≤ 70% predicted). Isometric and dynamic protocols will be conducted~     in two visits each, for a total of four visits a week a part. First, a venous blood sample~     will be taken from the patients. The isometric protocol will start with the determination of~     the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC)~     for the isometric endurance test (IET). Patients will be randomized to receive either the~     placebo or LED application. Immediately after finishing this procedure, the patients will~     carry out the IET until the limit of tolerance or until a 20% fall of strength is observed.~     After the test, another blood sample will be taken. In the other visit (one week later), the~     same order of procedures will be performed, except with the opposite (LED or placebo). For~     the dynamic protocol, the same procedures described above will be followed except with the~     maximal incremental cycle ergometer test used instead of the IET. The electromyography will~     be recorded during the isometric and dynamic protocols. Differences in muscle function,~     exercise capacity, and cardiorespiratory responses between the LED and placebo applications~     will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients~     with COPD by increasing exercise tolerance.~   "
161771|NCT01448551|"~     Obesity affects millions of American children and increases their risk of adult obesity, a~     myriad of serious illnesses, increased healthcare costs, and premature death. It is vital to~     find ways to reverse this epidemic. Multidisciplinary behavioral weight management programs~     offer the promise of effectively treating childhood obesity. However, participants in such~     programs often find it challenging to follow recommended treatment plans and frequently drop~     out from programs without completing them. The proposed project aims to address these~     problems through frequent contact with patients between office visits. This interim contact~     will be achieved by automatically sending tailored messages to the mobile phones of~     adolescents enrolled in a multidisciplinary weight management program (the MPOWER program),~     as an adjunct to clinic visits.~      The investigators hypothesize that program participants who receive the tailored text~     messages will experience lower attrition rates, increased treatment adherence, and greater~     weight loss compared to those program participants who do not receive the messages.~   "
161772|NCT01448538|"~     In the research study an observation of patients with wet age-related macular degeneration~     (wet AMD) will be performed.~      The term observational study indicates that the current course of therapy and the associated~     circumstances will be recorded. In this study, no medical care is changed. Also, no new drugs~     are tested.~      This study is being conducted in about 30 centers in Germany. A total of approximately 500~     patients will be enrolled. The study is designed for a period of 12 months.~      At the beginning and end of the study the physician will document the patient data. Therefore~     will be used information from the patient records and documented visits. If such information~     is not available in the study center, the otherwise attending ophthalmologist will be~     consulted about the vision acuity values and visits in the observation period.~      Furthermore, patients are asked to participate in three telephone interviews and fill out~     during their visits to the study center a short questionnaire about their current vision and~     their well-being. In the telephone interviews will be discussed with the patient about his~     wet AMD disease and its treatment, its experience and its perspectives as well as any~     problems occur.~   "
161773|NCT01448525|"~     The purpose of this study is to determine patient satisfaction with LATISSE® treatment for~     increasing eyelash prominence.~   "
161774|NCT01448512|"~     This study will evaluate the impact of combining two evidence-based interventions: a couples~     risk reduction intervention with an evidence based medication adherence intervention designed~     to enhance male participation in combination with improving medication and prevention of~     mother to child transmission (PMTCT) adherence in antenatal clinics (ANCs). Clinics will be~     randomly assigned to experimental and control conditions and effectiveness of the combined~     intervention to enhance PMTCT as well as reduce antenatal seroconversion by both individuals~     and clinics will be examined. It is hypothesized that community clinics implementing~     PartnerPlus will have more effective PMTCT program adherence, as measured by total~     participant 1) maternal and paternal ANC and PartnerPlus visits, 2) maternal and paternal~     human immunodeficiency virus (HIV) Counseling & Testing (HCT) uptake, 3) maternal and infant~     antiretroviral (ARV) prophylaxis uptake, 4) maternal highly active antiretroviral therapy~     (HAART) uptake, 5) infant polymerase chain reaction (PCR) for HIV, and 5) maternal and infant~     HIV serostatus and that community clinics implementing PartnerPlus will have reduced sexual~     risk behavior, as measured by participant sexual barrier use.~   "
161803|NCT01448135|"~     The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of~     the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish~     oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post~     surgical patients in the intensive care unit (ICU). If enough patients are recruited,~     inferences about impact on outcomes may also be drawn.~   "
161775|NCT01448499|"~     Background: schizophrenia is a debilitating mental disorder affecting about 1% of the general~     population. About 30% of patients will not react to current drug treatment and defined as~     treatment-resistant schizophrenia patients (TRSP). The best studied therapeutic option for~     this population is clozapine therapy. Clozapine was shown to be effective than any other~     antipsychotic drug in TRSP. Moreover, augmentation of clozapine was not demonstrated to be~     more effective than clozapine monotherapy. Albeit Clozapine superiority in TRSP, its use may~     be involved with many adverse effects, some of them are life-threatening, and need for~     routine blood tests. Amisulpride is an atypical antipsychotic drug with a different mechanism~     of action than clozapine, with less adverse effects. No study compared directly amisulpride~     and clozapine in TRSP.~      Study objective: to compare, for the first time, the broad clinical effectiveness of~     clozapine and amisulpride and their combination in TRSP.~      Study Design: a clinical, prospective, naturalistic, randomized, comparative study simulating~     a real-world approach of clinical decision making.~      Methods: a total of 140 TRSP will be recruited from a large regional mental health center.~     Participants will be randomized into two treatment groups (70 in each group): clozapine~     monotherapy and amisulpride monotherapy. Assessment will be done following 10 and 20 weeks of~     treatment. In case of treatment failure (insufficient clinical response or severe adverse~     effect) participants will be offered either to switch to clozapine treatment (for failed~     amisulpride treatment) or to augment clozapine with amisulpride (for failed clozapine~     monotherapy patients). Thereafter, participants will be followed-up for a year. Assessment~     will be made using clinician rated scales and self-completed questionnaires, rating the broad~     phenomenology of schizophrenia (psychosis, mood, anxiety, obsessive-compulsive, cognitive and~     quality of life) and drug-related adverse effects (objective and subjective).~      Analysis: comparison of the effectiveness of the three treatment groups: amisulpride,~     clozapine and their combination, in the various dimensions of TRSP.~   "
161776|NCT01448486|"~     HIV related cognitive impairment still occurs despite highly active antiretroviral therapy~     (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease~     leading to varying degrees of cognitive impairment, recently termed HIV associated~     neurocognitive disorders (HAND).~      HAND may occur in patients who are virally suppressed in both blood and CSF. Patients with~     HIV Associated Neurological Disorders (HAND) who are virally suppressed in both their blood~     and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral therapy (HAART)~     regimen may have significant cognitive improvement with HAART intensification with the~     medication Raltegravir; compared to those who remain on their existing regimen.~      This study will be a prospective, interventional, randomised and unblinded controlled~     clinical trial. The aim of this study will be to determine whether HAART intensification with~     the medication Raltegravir, leads to significant improvement in HIV associated neurological~     disorders (HAND).~      Patients with the recent progression (within 6 months) of HAND (validated by~     neuropsychological assessment) on HAART who are virally suppressed (<50 copies per ml) in~     blood and CSF will be randomised to have their existing HAART regimen intensified with~     raltegravir 400mg twice daily, or not. The control arm will remain on their medication~     regimen as prescribed. The target is to enrol 110 patients into the control group, and 110~     patients into the Raltegravir intensification group.~      Patients will undergo baseline neuropsychological testing, MRI, blood tests, and cerebral~     spinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the~     effectiveness of adding Raltegravir, will include further neuropsychological testing at 6~     months; and neuropsychological testing, MRI and CSF assessment at 12 months.~     Neuropsychological testing completed at 6 and 12 months will be completed by a blind~     assessor, in that they will have no knowledge of which arm (treatment or control) the~     participant is enrolled in.~      An evaluation (neuropsychological testing) will be performed should the patient deteriorate~     during the course of the study, as recognised by the patient's managing physician. The~     decision of the Antiretroviral medication regimen to be used in such a case will be~     determined by the managing physician. At the end of the study protocol (12 months) the~     patient's HAART therapy will be managed by their primary physician.~   "
161777|NCT01448473|"~     Minor head injuries are a common presenting complaint in the pediatric emergency department.~     Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of~     minor head trauma. However, there exists ongoing controversy regarding the ideal number of~     views that should be obtained in a skull series. This study aims to determine if there is a~     significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of~     fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film~     series is provided to participating pediatric emergency physicians.~   "
161778|NCT01448460|"~     Vitrification is a method of cryopreserving tissue for future use. It is widely used to~     preserve extra, good quality embryos generated from infertility treatments. It is becoming~     popular for the preservation of oocytes (eggs) as well, but is still considered~     investigational in this respect. The purpose of this study is to provide egg freezing for~     patients desiring fertility preservation. Although commonly used in clinics around the world,~     it should be offered as an IRB approved study procedure until it is no longer considered~     investigational by the American Society of Reproductive Medicine.~   "
161779|NCT01448447|"~     This study will evaluate the local control rate, cosmetic results, and complication rates of~     breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of~     radiation therapy or as a boost technique for patients with stage I-II carcinoma of the~     breast (< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative~     surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS.~      Hypotheses:~        -  For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS),~          radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is~          technically feasible and reproducible with acceptable complication rates.~        -  Cosmetic results after brachytherapy will be similar to that obtained after traditional~          whole breast external beam radiation therapy.~        -  Local tumor control rate in the breast after brachytherapy will be similar to that of~          conventional external beam radiation therapy, with less inconvenience and potentially~          less cost to the patient, given the selection criteria which minimize the risk of~          clinically significant multicentric or extensive residual carcinoma following~          lumpectomy.~   "
161780|NCT01448434|"~     This study is designed to know the safety and efficacy of 2 different doses of mesenchymal~     stem cells in patients suffering from osteoarthritis of knee joint.~   "
161781|NCT01448421|"~     This is a research study using the SMT Embolic Deflection Device and involving patients with~     aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic~     Valve Replacement (TAVR).~      The TAVR procedure consists in replacing the diseased aortic valve by a new artificial valve.~     The new valve is put into place using a long, thin tube called a catheter that is inserted~     into a small incision (cut) in the patient's groin and threaded through his/her arteries up~     to the heart.~      During the TAVR procedure, there is a risk that an abnormal particle (called embolism) could~     break off from inside the arteries and travel to the brain. The embolism could be made of~     clumps of blood (clots), air, part of your body tissue, or part of a medical device. If the~     embolism is carried through the blood to the brain, it could cause a stroke or other~     neurological (brain) problems. A stroke happens when blood flow to a part of the brain is~     blocked, causing brain cells to die.~      The SMT Embolic Deflection Device has been developed to prevent an embolism from going to the~     brain and causing a stroke or other brain damage. The device is a wire mesh filter that~     covers the vessels that carry blood to brain, deflecting any any blood clots or other~     materials away from the patient's brain and towards the lower body, where they are less~     likely to cause harm.~   "
161782|NCT01448408|"~     The present study attempts to evaluate the diagnostic capacity of a) anterior segment~     parameters b) biomechanical metrics and c) a combination model, in differentiating Forme~     Fruste Keratoconus (FFK) from healthy corneas.~      The study adhered to the tenets of the Declaration of Helsinki and written informed consent~     was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ),~     in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing~     primarily on the conditions of the anterior segment of the eye.~      All participants underwent a complete clinical evaluation including review of medical~     history, visual acuity measurements, uncorrected and best corrected visual acuity, placido~     disc topography, Scheimpflug camera measurements, ORA measurements , slitlamp biomicroscopy~     and fundoscopic examination.~      All study participants were divided in two groups. The FFK group (FFKG) consisted of patients~     with unilateral KC.~      The control group (CG) was formed by refractive surgery candidates who visited EIT's~     outpatients service for their preoperative examination.~      CRF and CH parameters were obtained while the patient was sitting on a chair in front of the~     Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device.~     Upon successful fixation of the patient's eye on a red blinking target, the operator~     activated the device. An air puff was released by a non-contact probe, which scanned the~     central area of the eye and sent a signal to the ORA. In brief, the air puff causes the~     cornea to move inward, past applanation, and into slight concavity. After milliseconds, the~     air pumps shut off, the pressure decreases, and the cornea begins to return in its normal~     state. The system monitors the entire process and measures two pressure values, which are~     determined from the inward and outward applanation processes. The aforementioned measuring~     procedure enables the determination of CH which is related to the viscoelastic structure of~     the corneal tissue, and is calculated as the difference between the two pressure values at~     the two applanation processes, and CRF which is indicative of the overall resistance of the~     cornea and is calculated as a linear function of the two pressures associated with the two~     applanation. In order to ensure accurate results, ORA was done four times for each eye, by~     the same operator. Signals that differ significantly in appearance from the other signals~     from the same eye were deleted.~      Corneal Astigmatism (Cyl), Anterior Chamber Depth (ACD), Corneal Volume at 3mm (CV3), at 5mm~     (CV5), and overall (CV), Central Corneal Thickness (CCT), Thinnest Corneal Thickness (TCT)~     and TCT co-ordinates (TCTx, TCTy) were obtained using Pentacam. KISA index was calculated~     using Pentacam derived topography. Pentacam is based on a rotating Scheimpflug camera and~     monochromatic slit light source (a blue light emitted diode at 475 nm) which rotate together.~     After proper alignment of the patient's head, a fixation target is shown which guides the~     patients gaze. A real time image of the patient's eye is shown to the examiner on the~     computer screen, and the image is manually focused and centered. Acceptable maps had at least~     10.0mm of corneal coverage. Moreover, images with extrapolated data in the central 9.0mm zone~     were excluded. Regarding the measuring procedure itself, patients were asked to blink and~     then look at the fixation device. In case of low-quality image, the procedure was repeated~     until the acceptable criteria were met.~      The data from the FFKG were compared with those from the CG in separate series analyses.~     Receiver operating characteristics (ROC) curves were applied to determine the overall~     predictive accuracy of the test for each studied parameter, as described by the area under~     the curve. We also used this approach to identify the cut-off points for studied parameters~     to maximize sensitivity and specificity in discriminating FFK cases from normal corneas.~     Logistic regression was used to support the cut-off point identified in the ROC curve~     analysis. We determined a cutoff value that will gave us the best predictive fit for our~     sample data. Furthermore, logistic regression analysis was performed to determine the~     predictive capability of a model that combined both corneal biomechanical properties and~     pentacam derived anterior segment parameters.~      Differences between groups were evaluated using the Welch modified Student's two sample~     t-test and Mann-Whitney U test, according to normality of distribution for each parameter. A~     Kolmogorov-Smirnov test of normality was applied to all variables of each group. The level of~     significance for each parameter was set at p<0.05. The Pearson and Spearman tests were~     performed in order to assess correlations between anterior segment parameters and~     biomechanical properties, depending on their parametric evaluation.~   "
161783|NCT01448395|"~     A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body~     when given as an injection into the blood stream.~   "
161834|NCT01447732|"~     This is a two-part, Phase 1 open label, multi-center, dose escalation study of~     CEP-37250/KHK2804 as monotherapy in subjects with advanced solid tumors who no longer respond~     to standard therapy or for whom no standard therapy is available.~   "
161784|NCT01448382|"~     1. Primary Scientific Objective~             -  Collect human clinical data to sustain the development of blood detection sensor~               and optimize its algorithm and parameters~             -  Preliminary evaluation of blood detection performances in human.~        2. Secondary Scientific Objective~             -  Assessment of blood detection sensor ability to identify the anatomical location~               (i.e. Stomach, SB or Colon)~             -  Evaluation of capsule transit characteristics in the GI tract~             -  Evaluation of BBC capsule safety~      Study Hypothesis:~      It is estimated that by implementing a spectrophotometer technology in capsule and utilizing~     the unique characteristics of light absorption by blood in specific spectrum, the capsule~     will be able to automatically detect blood in the GI tract with high accuracy. As such, the~     system may be an add-on to video capsules to provide efficient and quick detection of blood~     presence (for example in OGBI patients) or as stand alone low cost capsule (without video)~     which could serve as a tool similar to standard FOBT.~   "
161785|NCT01448369|"~     Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than~     half of some Asian populations), affects the lipid producing meibomian glands in the eyelids.~     One function of the glandular secretions is to reduce evaporation of the tear film. In MGD~     the meibomian glands may become blocked for various reasons. The consequential retention and~     stasis of the secretion increases immune response as well as scarring response. This~     eventually results in an abnormal tear film and dry eye symptoms.~      The current standard treatments include warm moist compresses, regular lid hygiene, oral~     antibiotics, topical antibiotic ointments and Omega 3 supplementation. Heating for an~     extended duration is important because it relieves the occlusion of blocked meibomian glands.~     However, improvised methods of heating are cumbersome and inefficient requiring repeated~     measures, often leading to lack of compliance. Today, there is a wider range of commercially~     available devices that help to unblock meibomian glands and relief dry eye symptoms. These~     devices may improve MGD treatment dramatically, but have not been tested in the warm climate~     of Singapore, and are not readily available.~      The current study aims to test the efficacy of treatment for devices that utilize A) warm~     moisture (Blephasteam) and B) warmth (EyeGiene) in patients suffering from meibomian gland~     dysfunction. Patients will be asked to use Blephasteam and EyeGiene for a period of 4 weeks.~     The study will monitor patients for changes in tear film and lipid composition, as well as~     changes in the anatomy of meibomian glands. Additionally, dry eye symptoms will be documented~     in form of questionnaires. If the newer methods of managing MGD are found to be efficacious~     and safe, these treatment measures can be made available to patients in Singapore.~   "
161786|NCT01448356|"~     Dry eye and ocular surface disease account for a lot of morbidity and socio-economic burden~     in Asia and the rest of the world. This is a small pilot study to evaluate tear function~     under different conditions of humidity and temperature. This data will be useful for~     designing future trials in ocular surface and dry eye. The data will likely be used to~     propose a larger national funded project involving clinical trials. This study involves~     collaboration between engineers, ocular surface clinicians as well as specialists from the~     defence science organisation. When successfully completed, the project will increase the~     capability of Singapore Eye Research Institute and Singapore National Eye Centre to support~     future industry and academic research in the ocular surface.~   "
161787|NCT01448343|"~     Rapid infusion of red blood cells is known to result in the increase of plasma potassium. The~     researchers are trying to investigate the change in plasma potassium during rapid infusion of~     mixed blood components in the reservoir of the fluid management system (FMS) in liver~     transplant recipients.~   "
161788|NCT01448330|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of clopidogrel and aspirin in free combination as HCP0911.~   "
161789|NCT01448317|"~     Primary Objective:~      To assess the safety and tolerability of ascending single doses of subcutaneously (SC)~     administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.~      Secondary Objectives:~        -  To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum~          low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as~          total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density~          lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides,~          Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).~        -  To assess the Pharmacokinetic profile of a single SC dose of alirocumab.~        -  To assess the immunogenicity of a single SC dose of alirocumab.~   "
161790|NCT01448304|"~     Primary Objective:~      Injection Site Tolerability~      Secondary Objective:~        -  To assess the safety profile of alirocumab SAR236553 (REGN727)~        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553~          (REGN727)~   "
161791|NCT01448291|"~     It is not known if the use of NuvaRing® alters these innate and inflammatory biomarkers of~     inflammation.~      Hypothesis:~      The hypothesis is that NuvaRing® will alter inflammatory biomarkers of inflammation, such as~     vaginal defensin and cytokine levels, resulting in an overall anti-inflammatory milieu in the~     vagina.~      Specific aims of this study are to:~        1. Determine biomarkers of inflammation, including defensins and cytokines, concentrations~          in women with normal vaginal flora (Nugent Score 0 - 3) before and after NuvaRing® use~        2. Determine changes in the integrity of cervicovaginal epithelium and leukocytic~          concentration before and after treatment with NuvaRing®~        3. Monitor for changes in the Nugent score before and after NuvaRing® use~        4. Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use~        5. Assess HIV infectivity ex vivo on biopsy specimens before and after NuvaRing® use~      Methods This is a prospective, open-label, nonrandomized study. Participants will serve as~     their own controls. The Clinical Research Center of Eastern Virginia Medical School, Norfolk,~     Virginia, U.S.A. will be the only study site.~   "
161792|NCT01448278|"~     The All-inside method is a new minimally invasive procedure for anterior cruciate ligament~     reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation.~     In the so-called classical method, the fixation is achieved with interference screws.~      The hypothesis of this study was that the All-inside technique causes less pain than the~     conventional technique. The main objective was to evaluate the immediate postoperative pain~     for the first ten days and at one month from the intervention.~   "
161864|NCT01447342|"~     A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of~     the cryo-touch II device for the treatment of forehead and/or glabellar lines~   "
161793|NCT01448265|"~     Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia,~     impairs quality of life and increases stroke risk and mortality. Recent clinical experience~     with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can~     be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF,~     thereby eliminating the recurrence of AF.~      Hypothesis: Our hypotheses are (1) that visualization of real-time pulmonary vein conduction~     during cryoballoon ablation of atrial fibrillation using a novel spiral circumferential~     mapping catheter (Achieve™) is feasible and safe, and (2) that procedure and fluoroscopy~     times decrease with experience.~      Objective: The purpose of this study is to assess safety, feasibility, and a learning curve~     associated with cryoballoon catheter ablation using a novel circular mapping catheter~     (Achieve™, Medtronic) inserted through the lumen of the cryoballoon in patients with~     symptomatic paroxysmal atrial fibrillation.~      The primary goal is to evaluate successful pulmonary vein isolation using the Achieve™~     mapping catheter. The reduction of procedure and fluoroscopy times during the first 40~     patients treated with this approach will be analyzed to evaluate a potential learning curve~     upon introduction of the technique.~   "
161794|NCT01448252|"~     This is a double blind phase I-II clinical trial with multiple autologous T cell vaccinations~     using T cell lines reactive to 9 different myelin peptides of MBP, MOG and PLP, in patients~     with relapsing progressive Multiple Sclerosis.~   "
161795|NCT01448239|"~     Primary Objective:~      Injection Site Tolerability~      Secondary Objectives:~        -  To assess the safety profile of alirocumab SAR236553 (REGN727)~        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553~          (REGN727)~   "
161796|NCT01448226|"~     Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in~     patients (pts) with hematologic malignancies. As culture-based methods only yield results in~     a minority of patients, using non-culture-based methods for detection of aspergillosis in~     clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL)~     samples with polymerase chain reaction (PCR) is promising, however, the influence of current~     antifungal drugs on the performance of this diagnostic tool remains controversial.~      The aim of the trial is to elucidate on the performance of BAL PCR under antifungal~     treatment.~   "
161797|NCT01448213|"~     The purpose of this study is to compare two different commonly used steroid dosing regimens~     after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The~     investigators hope to determine if one is more effective at preventing rejection or if both~     are equally effective.~   "
161798|NCT01448200|"~     PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a~     potential treatment for hepatitis C virus infection. This study is being done to assess the~     safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of~     the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study~     will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of~     PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels)~     also will be assessed.~   "
161799|NCT01448187|"~     The aim of the study is to describe the characteristics of patients treated with Iressa~     (particularly age, gender, phenotype, histology and stage of disease, line of treatment and~     previous treatments, smoking history, conditions of initiation of treatment (presence of an~     EGFR-activating mutation) and to evaluate the impact of treatment on the health of the~     population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and~     quality of life~   "
161800|NCT01448174|"~     Hyperlipidemia and atherosclerosis lead to cardiovascular diseases and are an indirect cause~     of increased death rate in the general population. This association is still more evident in~     specific subpopulations, like patients with advanced chronic kidney disease (CKD), especially~     hemodialysis (HD) patients, due to a higher prevalence of lipid disturbances and~     atherosclerosis compared to the general population. Cardiovascular events in CKD patients are~     frequently associated with traditional risk factors, including diabetes, male sex,~     hypertension, dyslipidemia and advanced age. However, these factors failed to fully account~     for the increased risk of cardiovascular events in CKD. The efforts are made to identify new~     risk factors that contribute to the development of atherosclerosis and participate in causes~     of cardiovascular death. In 2003, there were identified peptides designated salusin-alpha and~     salusin-beta. Development of atherosclerosis may be suppressed by salusin-alpha.~     Salusin-alpha may have a lipid lowering effect, similar to that of statins.~      The purpose of this study is to investigate whether 1) salusin-alpha is associated with lipid~     metabolism of HD patients (without or with metabolic syndrome or type 2 diabetes mellitus),~     similarly or not like in healthy or obese subjects; 2) treatment with atorvastatin and its~     effects are associated with changes in plasma salusin-alpha concentration, if so - whether it~     is dependent on the direct influence of atorvastatin on salusin-alpha or associated with a~     decrease in serum lipid level; 3) salusin-alpha may predict mortality in HD patients.~   "
161801|NCT01448161|"~     Study hypothesis: Machine Learning algorithms and techniques previously developed for use in~     the robotics field can be applied to the field of medicine. These state-of-the-art, feature~     extraction and machine learning techniques can utilize patient vital sign data from bedside~     monitors to discover hidden relationships within the physiological waveforms and identify~     physiological trends or concerning conditions that are predictive of various clinical events.~     These algorithms could potentially provide preemptive alerts to clinicians of a developing~     patient problem, well before any human could detect a worrisome combination of events or~     trend in the data.~      Specific aims:~        1. Collect physiological waveform and numeric trend data from patient vital signs monitors~          in ICUs at the University of Colorado Hospital and Children's Hospital Colorado.~        2. Combine the physiological data from patient monitors with clinical data obtained from~          patient Electronic Medical Records including IV fluids, medications, ventilator~          settings, urine output, etc. for use in developing models of various clinical~          conditions.~        3. Apply Machine Learning techniques to these models to identify physiological waveform~          features and trend information, which are characteristic and predictive of common~          clinical conditions including but not limited to:~             -  Post-operative atrial fibrillation and other cardiac dysrhythmias~             -  Post-operative cardiac tamponade~             -  Tension pneumothorax~             -  Optimal post-operative and post-resuscitation fluid needs~             -  Intracranial hypertension and cerebral perfusion pressure~   "
161804|NCT01448122|"~     The main objective of the study is to assess the efficacy of Avène Compact Honey in~     preventing pigmentation induced by visible light in subjects with a phototype III or IV.~      Patients will be exposed to a range of visible light to areas on the back to confirm study~     eligibility. Patients showing pigmentation after 7 days on the exposed areas will be eligible~     to continue.~      Eligible patients will have study product applied to part of the back. The back will be~     exposed to a range of light based on the minimum exposure inducing pigmentation previously~     ascertained. The area where study product is applied will have a higher range of light~     exposure than the area without the study product.~      Seven days later, the areas will be examined to determine the lowest exposure inducing~     pigmentation on the sides with and without study product. The color will also be measured~     between two identical exposures with and without the applied study product.~   "
161805|NCT01448109|"~     The purpose of this study is to find out whether adult patients admitted to the Intensive~     Care Unit with septic shock who are given hydrocortisone compared to placebo (a dummy~     solution), will have an improved rate of survival 90 days later.~      Septic shock is the result of an infection, which triggers a complex response by the body~     (the inflammatory response) that causes a decrease in blood pressure and subsequently one or~     more organ systems to fail when blood supply to these organs is reduced. This may result in~     poor recovery and death. About a quarter of the people who suffer septic shock that is not~     rapidly reversed, will die.~      When patients are admitted to Intensive Care with sepsis and/or septic shock they receive a~     number of therapies. These include fluids given through a drip, antibiotics, drugs to boost~     your blood pressure and other organ systems.~      In addition to these therapies, steroids (hydrocortisone) are sometimes administered. Whether~     steroids are useful or not in the treatment of severe infections has been studied for more~     than 50 years. Previous research has suggested that the use of low dose steroid may have~     shortterm benefits in improving the circulation. However, there is no agreement amongst~     doctors around the world about whether treatment with or without low dose steroids improves~     the overall recovery and survival in patients with septic shock. This study would allow~     doctors to make informed decisions about whether the addition of low dose steroid therapy is~     better for patients with septic shock in intensive care.~      The study will include 3800 intensive care patients who have septic shock. Each enrolled~     patient will be randomised to receive either Hydrocortisone 200mg or placebo daily for 7 days~     as a continuous intravenous infusion while in intensive care. The patient will be followed~     for 90 days. If the patient is discharged prior to 90 days a telephone call will be made for~     the followup information. At six months the patient will be contacted again for completion of~     a quality of life questionnaire.~   "
161806|NCT01448096|"~     The purpose of this study is to clarify the impact of rituximab on clinical outcomes in~     patients with primary breast diffuse large B-cell lymphoma and also to investigate the role~     of prophylactic intrathecal chemotherapy using methotrexate for reducing central nervous~     system (CNS) recurrence.~   "
161807|NCT01448083|"~     The purpose of this study is to determine if the measurement (with a standard nuclear camera)~     of radioactivity normally present in the nervous system of your heart at four hours after the~     injection of radioactive drug for your diagnostic I-123 MIBG scan is any different than~     radioactivity measured in your heart at one and/or two hours after your diagnostic scan~     injection. If equivalent information to the conventional 4 hr H/M ratio could be collected by~     obtaining H/M ratios at 1 or 2 hour windows, it would greatly facilitate patient acceptance~     of the procedure since the requirements for obtaining a valid H/M ratio would be considerably~     less time-consuming.~      One hour before being injected with the drug (I-123 MIBG) for your MIBG scan, you will be~     given a standard dose of non-radioactive iodine (Lugol's solution) to block your thyroid from~     receiving the small amount of radiation that is a normal part of the MIBG scan. You will then~     be injected with MIBG, and you will have 10 minute pictures of your chest at 15 minutes, 1~     hour, 2 hours, and 4 hours in addition to the standard 24 hour pictures. These pictures will~     be taken in the Nuclear Medicine Section, Department of Radiology at Ochsner Medical~     Center-Kenner. The experimental (research) part of this study is having the extra 10-minute~     pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours. Normally, pictures are~     only taken 24 hours after the injection. Therefore the research is limited to the four extra~     pictures taken, and involve no additional injections or I-123 drug beyond that you will be~     receiving regardless of whether you are part of this research.~   "
161808|NCT01448070|"~     This trial is conducted in Europe. The aim of this trial is to show that the product of the~     new production process has a similar pharmacological profile to the traditional process used~     for the current commercial product Actrapid®.~   "
161809|NCT01448057|"~     The study is a clinical evaluation of an over the counter (OTC) combination product~     containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10~     mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea,~     sneezing and other symptoms due to upper respiratory tract infection (URTI).~   "
161810|NCT01448044|"~     The purpose of this study is to compare the sustained virologic response at post treatment~     Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV)~     versus placebo/PegIFNα-2a/RBV).~   "
161811|NCT01448031|"~     This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between~     Esomeprazole and Aspirin after multiple dose administration.~   "
161812|NCT01448018|"~     The purpose of this study is to compare ranibizumab injection to hemodilution at the early~     phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both~     treatments may have a synergic effect.~   "
161813|NCT01448005|"~     This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35%~     following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that~     wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing~     arrhythmic death in this select population with high risk for sudden cardiac death (SCD).~     This is a pilot project to determine the feasibility of a larger-scale study.~   "
161814|NCT01447992|"~     A single arm, single treatment study is proposed to assess the feasibility of a portable~     artificial pancreas system outside of a hospital based clinical research center.~      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous~     insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions~     (hotel).~   "
161815|NCT01447979|"~     A single arm, single treatment study is proposed to assess the feasibility of a portable~     artificial pancreas system outside of a hospital based clinical research center.~      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous~     insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions~     (hotel).~   "
162238|NCT01442272|"~     The purpose of this study is to determine the value the additional antiproteinuric effects of~     vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV, with~     lack of vitamin D and residual proteinuria higher 0,5 grams/day.~   "
161816|NCT01447966|"~     The purpose of this research study is to further investigate how well cognitive-behavioral~     psychotherapy works to reduce obsessive-compulsive symptoms in young children with~     obsessive-compulsive disorder (OCD). Cognitive-behavioral therapy has been shown to work well~     in youth with OCD and other anxiety disorders; however, there are only a few studies to date~     in preschool and young children with OCD. All children will have the option to receive 12~     twice-weekly cognitive-behavioral psychotherapy sessions that are up to 60-minutes each.~     Randomly determined, half of all children will receive these sessions immediately following~     the pre-assessment and the remaining half will receive them after six weeks. The~     investigators expect that youth receiving the study-based therapy will show more improvement~     in OCD symptoms in six weeks in contrast to youth waiting to receive the therapy.~   "
161817|NCT01447953|"~     The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability~     and facilitate return-to-work. However, there is a lack of treatment strategies that~     effectively target and affect return-to-work and reduce sickness absence, and that in~     addition are sufficiently easy and feasible to administer in primary care. A new activity and~     life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial~     barriers to rehabilitation progress, promote re-integration into life-role activities and~     facilitate return-to-work. The program will be implemented and provided as one of the pain~     treatment modalities available through multi-professional teams in primary care in one~     Swedish county. This study aims to evaluate the effect of an activity and life-role targeting~     pain rehabilitation program on the outcome variables return-to-work and sickness absence.~   "
161818|NCT01447940|"~     Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine~     ePortal for sharing information between diabetologist and type 1 diabetic patient is not~     inferior to a conventional care regarding metabolic results at 12 months.~   "
161819|NCT01447927|"~     This randomized phase II trial studies how well metformin hydrochloride works in preventing~     esophageal cancer in patients with Barrett esophagus. Chemoprevention is the use of certain~     drugs to keep cancer from forming. The use of metformin hydrochloride may keep esophageal~     cancer from forming.~   "
161820|NCT01447914|"~     This phase II trial studies the side effects and how well tivantinib works in treating~     patients with relapsed, or relapsed and refractory multiple myeloma. Tivantinib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
161821|NCT01447901|"~     LPL (Lipoprotein Lipase) is an enzyme which plays an important role in the elimination of~     triglycerides (fat) and the clearance of dietary fat particles known as chylomicrons (CM) in~     the blood. In patients who have an abnormal LPL gene, the enzyme does not work (total,~     hereditary LPL deficiency), which results in a large increase in the amount of triglycerides~     (fats) and chylomicrons in the blood. This increases the risk of inflammation in the pancreas~     and leads to long term negative effects for bloods vessels (atherosclerosis). Current~     medications and / or a strict and low fat diet do not sufficiently reduce the level of~     triglycerides in order to prevent these conditions. To solve this problem, the company, AMT~     is developing a gene therapy (AMT-011).~      In normal healthy individuals, fat particles are rapidly cleared from the circulation~     following a standard meal. Within approximately 3 hours the highest levels of fat is reached~     and clearance is achieved within the subsequent 9 hours. In LPLD subjects, the clearance of~     fat is greatly reduced as a direct consequence of the lack of LPL. During this study, a~     standard meal with a tracer (3H-palmitate) is given. Since palmitate is incorporated in the~     dietary fat, this study enabled monitoring of appearance of newly formed dietary fat into-~     and clearance of these newly formed dietary fats from the circulation, over time.~      The principal aim of the study is to verify if the gene therapy (AMT 011) is still effective~     in the treatment of this condition. Systemic appearance and clearance of new formed dietary~     fat particles after ingestion of the meal will be determined by measuring the level of tracer~     at different time points.~   "
161822|NCT01447888|"~     The purpose of this study is a comparison of pain management in opioid-tolerant spine surgery~     patients using a perioperative dosing goal of 150% of patient's baseline oral morphine~     equivalent (OME), as compared to standard perioperative dosing, which does not currently~     account for patients' baseline opiate use.~   "
161823|NCT01447875|"~     Hypotension and bradycardia are often observed following induction of dexmedetomidine or~     propofol sedation.Cardiac preload decrease by sedative agents was often considered as one of~     main causes for this hypotension.The investigators hypothesized that hypotension after~     induction of sedation is caused by decrease of preload by sedative agents,and passive leg~     raising (PLR)test could predict this event.Dexmedetomidine or propofol infusion in patients~     with circulatory failure decrease cardiac preload and enhance preload-dependency and fluid~     responsiveness.~   "
161824|NCT01447862|"~     Atrial fibrillation is the most common cardiac arrhythmia and is expected to affect about 30~     million North Americans and Europeans by 2050. Atrial fibrillation is associated with~     increased cardiovascular morbidity and mortality, with stroke being an especially important~     and potentially devastating complication. Many studies have investigated the efficacy of~     different drugs in converting atrial fibrillation to sinus rhythm. There are numerous~     randomized controlled trials that have tested the efficacy of agents against placebo and some~     trials that directly compared the efficacy of two or more different drugs. The class III~     antiarrhythmic drug Ibutilde is approved for the acute termination of atrial fibrillation and~     atrial flutter of recent onset and has been shown to be superior to sotalol and equivalent to~     flecainide in this indication. Recently, the relatively atrial selective antiarrhythmic agent~     vernakalant has been approved by the European Commission for the rapid conversion of recent~     onset AF to sinus rhythm in adults. The investigators hypothesize that the period of time~     needed for cardioversion to sinus rhythm and the efficacy of cardioversion within 90 minutes~     is different between vernakalant and ibutilide in patients with recent-onset atrial~     fibrillation.~   "
161825|NCT01447849|"~     The investigators hypothesize that the symptoms of chronic constipation in some patients are~     developed due to diminished production and secretion of the alimentary tract mucus resulting~     in poor lubrication.~      Therefore, the investigators assume that administration of lubiprostone may restore this~     lubrication impairment by stimulation of mucus production and secretion within the~     gastrointestinal tract.~   "
162239|NCT01442259|"~     The aim of this study was to characterize the pharmacokinetics and safety of AFQ056 in~     subjects with a different degree of renal impairment.~   "
161826|NCT01447836|"~     Liver injury is a complication of sepsis and septic liver injury has adverse impact upon the~     outcome. As a measurement for liver function, Plasma clearance rate of indocyanine green~     (PDR-ICG) always decreased during the early phase of sepsis. So the investigators hypotheses~     include: PDR-ICG is lower in sepsis patients than non-septic patients in ICU; PDR-ICG may be~     lower in abdominal sepsis patients than non-abdominal sepsis patients in ICU; PDR-ICG~     correlates with abdominal perfusion pressure; change of PDR-ICG in early phase correlates~     with change of transaminase or bilirubin in late phase of sepsis.~   "
161827|NCT01447823|"~     The aim of this study is to evaluate standard investigations performed in patients with bolus~     impaction in a prospective observational field study. In bolus impaction, ingested food~     boluses have to be endoscopically removed. Oesophageal narrowing by scar tissue caused by~     reflux disease or motility disorders are possible causes of bolus impaction. How common these~     causes are has up to date never been investigated. The discovery of eosinophilic oesophagitis~     has broadened differential diagnosis of bolus impaction. Currently high resolution~     oesophageal manometry and 24-hour pHmetry are performed in addition to endoscopy in the~     assessment of bolus impaction at the University Hospital Zurich.~      The collection of these examination results is the aim of this prospective unrandomised~     observational field study to assess weather the currently applied procedures are valid to~     diagnose the cause of impaction to find optimal therapy for each patient.~   "
161828|NCT01447810|"~     Hemiplegia (weakness or poor muscle function on one side of the body) is a neurological~     impairment which can occur in children as a result of a brain tumor or related treatment.~     This impairment can negatively impact the child's functional abilities and movement~     development, making it difficult for them to play, learn to feed, dress or bathe themselves,~     and to participate fully in home, daycare, or school environments. Poor movement skills may~     also impact overall quality of life. Constraint Induced Therapy is a rehabilitation technique~     which has been found to improve the child's abilities to move their arms following~     neurological injuries like stroke and traumatic brain injury in both adults and children.~      The aim of this study is to evaluate the feasibility of implementing a constraint induced~     movement therapy program in a small group of children with a brain tumor and hemiplegia.~     Children who participate in the program may experience improved ability to use their weak arm~     leading to increased participation in meaningful activity and improved quality of life.~   "
161829|NCT01447797|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of Irbesartan and Atorvastatin in combination as HCP0912~   "
161830|NCT01447784|"~     House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and~     fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is~     associated with poorer lung function, greater medication requirements and more asthma~     symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is~     evidence that HDMA leads to the development of asthma, in addition to exacerbating~     pre-existing asthma in HDM-sensitised patients.~      ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine,~     currently being developed for the treatment of HDM allergy~      This study will look at the efficacy, safety and tolerability of three doses of ToleroMune~     HDM in HDM allergic subjects following challenge with HDM allergen in an Environmental~     Exposure Chamber (EEC)).~   "
161831|NCT01447771|"~     Breast cancer is a common malignancy among women in the United States. There are a variety of~     treatment decisions that need to be made. This study has been developed after a review of the~     literature demonstrated that women with breast cancer are making decisions regarding complex~     therapy issues in a way that is not congruent with their decision-making control preference.~      Some patients want to be empowered with information so that they can actively participate in~     the decision making about their care; others want to rely on the recommendations made by the~     oncologist. This is important because patients who were not satisfied with their adjuvant~     treatment decision noted a negative effect on quality of life and self image. These patients~     had more difficulties with treatment side effects; including aches, hot flashes, pain, and~     mood alteration. In additions the Institute of Medicine recommended that patient centeredness~     be a key aim of health care organizations and that all patients be given the opportunity to~     exercise the degree of control they choose over health care decisions that affect them.~      It is hypothesized that women making decisions regarding adjuvant therapy who are supported~     to make decisions based on their preferred level of control will have positive psychological~     outcomes.~   "
161832|NCT01447758|"~     The purpose of this Phase Ib study is to investigate the safety, tolerability and~     pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions~     from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I,~     II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be~     performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that~     increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation~     of the safety and tolerability data will assess whether a stepwise increase in the percentage~     of to be treated BSA is justified. Cohort IV will start dosing after finalisation of Cohort~     II and after submission of data from Cohort I and II to the national authority and IEC for~     review.~   "
161833|NCT01447745|"~     Although it is frequently mentioned in the media that overweight and obesity have reached~     epidemic proportions worldwide and in this country, some Canadians are perplexed and~     sometimes confused about the role of obesity in diabetes and heart disease. In fact, the~     investigators even hear from time to time that there could be healthy obese individuals. In~     clinical practice, assessment of obesity as a risk factor for cardiovascular disease (CVD)~     remains a challenge as even some physicians are confused. However, studies conducted in our~     laboratory and by other research teams around the world over the last 20 years have clearly~     shown that body shape is more important than body size when evaluating the risk of~     overweight/obesity and that high accumulation of abdominal fat (excess belly fat) increases~     the risk of diabetes and cardiovascular disease (CVD).~      The investigators now need to better understand the link between excess belly fat and~     atherosclerosis (the thickening of artery walls by fatty deposits, also referred to as~     atherosclerotic plaque), leading to complications such as angina (chest pain) and myocardial~     infarction (heart attacks). Using non-invasive imaging techniques such as magnetic resonance~     imaging, the investigators therefore propose to examine the relationships between measures of~     fatness and of abdominal fat and the size of atherosclerotic plaque in large blood vessels of~     apparently healthy human subjects. This study is also a unique opportunity to look, for the~     first time, at the relationship between belly fat, blood sugar, several well-known risk~     factors for heart disease (cholesterol, blood pressure, cardiorespiratory fitness, etc.) and~     the size of atherosclerotic plaques. This research program should pave the way to the~     development of new improved preventive/therapeutic approaches focusing not on body weight but~     rather on abdominal fat and associated blood abnormalities which are predictive of the~     development of atherosclerotic plaques leading to the premature development of heart disease.~   "
161835|NCT01447719|"~     This study is designed to test the relationship between measurements of brain amyloid using~     florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by~     histopathological assessment. The study will address the following specific aims:~        1. To expand the number of subjects included in the A07 (NCT00857415) trial correlation~          analysis (measuring the correlation between the global visual rating of brain amyloid~          plaque density on an independent blinded read of the florbetapir F 18 PET scan and the~          cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in~          the autopsy cohort).~        2. To determine the sensitivity and specificity of an independent blinded visual read~          assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded~          neuropathological assessment made at autopsy.~   "
161836|NCT01447706|"~     To determine whether the combination of MM-121 plus paclitaxel is more effective than~     paclitaxel alone~   "
161837|NCT01447693|"~     Background.~      Uremic pruritus is still a common phenomenon in patients with end-stage renal failure. It is~     regarded as one of the most bothersome symptoms in patients on chronic dialysis.~      The pathogenesis of uremic itch remains unclear. Several theories have been proposed like~     dryness of the skin, imbalance in divalent ions, peripheral neuropathy and others.~      Many treatment modalities have been tried to reduce uremic pruritus, however , the majority~     of them produced only temporary improvement. Therefore , every new therapeutic option for~     uremic pruritus is desirable.~      This study will undertaken to evaluate the efficacy of a cream which included olive oil and~     omega-3 fatty acids.~      Olive Omega-3 is an efficient product that soothes itchiness of cracked and very dry skin.~      The product is unique and based on patented technology developed by the Technion Research and~     Development Foundation in Haifa.~      Olive Omega-3 is an ointment composed of all natural ingredients. The main active ingredients~     are extra virgin olive oil , fish oil and vitamin C. The oils provides the skin with fatty~     acids that are vital for its proper functioning and help in the skin recovery. Sugar cane~     extract improves the skin's flexibility by removing dead cells and enhancing water retention~     in the upper layer of the skin.~      When applied on clean skin , the product is quickly absorbed , producing a sensation of~     relief within a short time period. Treatment can be repeated as often as required with no~     limitations and its use is not contraindicative of any other medical treatment.~      Patients and Methods.~      About 20 patients on chronic hemodialysis suffering from uremic pruritus will be include in~     the study.~      All patients will undergo dermatologic examination. All patients will be score by intensity~     of itching according to 3-point scale , as follows:~        1. - patches of fine , powdery scales~        2. - moderate scaling with beginning cracks~        3. - intense scaling , moderate cracks The patients all applied Olive Omega-3 ointment for~          50% of body and Vaseline ointment for the second one. The treatment will repeated twice~          daily for two weeks.~      At the end of 2 weeks application global tolerance will evaluate using the following 3-point~     scale:~        1. very good~        2. good~        3. poor~      At the same time global agreement of the patients will evaluate according to the following~     scale :~        1. - very satisfactory~        2. - satisfactory 3- poorly satisfactory.~      Statistical analysis will be performed by use of Wilcoxon test .~   "
161838|NCT01447680|"~     The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody~     testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma~     is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™~     in the USA).~   "
161839|NCT01447667|"~     The purpose of this study is to determine:~        -  The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA~          treatment~        -  The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the~          gold-standard histology score predicting hepatic fibrosis~   "
161840|NCT01447654|"~     Objective The objective of the study is to assess the structural and functional cardiac~     effects of treatment with losartan in patients with hypertrophic cardiomyopathy (HCM).~      Design The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up~     period is 12 months. 130 patients with HCM will be included in predefined subgroups. Genotype~     positive relatives with borderline hypertrophy (> 13 mm) will also be included. Data on~     individuals with borderline hypertrophy will be analysed separately from the rest of the~     cohort.~      Primary outcome Ventricular hypertrophy assessed as left ventricular mass and maximal wall~     thickness.~   "
161841|NCT01447641|"~     The purpose of this study is to assess both the sleep and circadian (24-hourly biological~     rhythms) physiology of people with cluster headache. For sufferers with the episodic form of~     the disorder this will involve observation at two separate time points, once when~     experiencing attacks (in-bout) and once when attack free (out-of-bout).~      The study will include measurement of basic rest-activity patterns, sleep timing and timing~     of individual attacks, as well as a more detailed study recording sleep and circadian rhythms~     under clinical conditions over consecutive nights.~      Studying the differences in these processes in single individuals when they are both~     experiencing and free from attacks might provide insight into the brain mechanisms involved~     in triggering the bouts of attacks and individual attacks themselves. An improved~     understanding of this area may help design improved treatment options in future.~   "
161842|NCT01447628|"~     This study will establish whether intravenous iron replacement has clinical benefit in~     idiopathic pulmonary arterial hypertension.~      A 24-week double-blind, randomised, placebo-controlled, crossover study will investigate~     whether a single dose of 1g of Ferinject® or CosmoFer improves cardiopulmonary haemodynamics,~     exercise capacity and quality of life and is well-tolerated.~   "
161843|NCT01447615|"~     Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda, represents~     the first study that measures medium-term efficacy and cost-effectiveness of a family~     economic empowerment intervention for AIDS-orphaned children. The usual care provided to AIDS~     orphans in sub-Saharan Africa consists mainly of informal counseling as well as limited~     material support (e.g., specifically school lunches, textbooks for the required subjects, and~     note-books). Given the challenges facing these children and their caregivers, further~     supports are needed in order to help them successfully make the transition from primary~     school to secondary school and into adolescence. In the context of resource-poor countries,~     interventions that improve families' economic capabilities are likely to be particularly~     consequential. Both theory and prior research indicate that economic instability (including~     poverty) constitutes one of the primary risk factors for AIDS-orphaned children's risk-taking~     behaviors (including sexual risk-taking), poor mental health functioning, and poor~     educational outcomes. Thus, the lack of economic security constitutes an important risk~     factor for AIDS-orphaned children. Yet, to-date, few interventions aimed at care and support~     of AIDS-orphaned children have incorporated components to address family-level~     poverty/economic instability of the children and their caregiving families. Within this~     context, there is a need for innovative interventions that promote sustainable (more than~     short-term) economic and behavior change among AIDS-orphaned children and create the supports~     necessary to sustain these changes.~   "
162266|NCT01441908|"~     The primary objective of this study is to determine any changes in cardiovascular risk among~     individuals receiving a statin by assessing their multi-analyte profile.~   "
161844|NCT01447602|"~     The investigators are adapting Interpersonal Psychotherapy (IPT-A) for adolescents who are~     referred to emergency services either for a suicide attempt or for being evaluated as high~     risk for suicidal behavior. The investigators will recruit 15 adolescents ages 12-19 years~     who present with a diagnosis of major depression, dysthymic disorder, depression disorder not~     otherwise specified who have a history of a suicide attempt in the past 2 months or a~     non-medically lethal attempt that may require psychiatric hospitalization, suicide attempt~     that is or report current suicidal ideation with a plan/intent, and treat them in an open~     clinical trial. The treatment will be conducted twice weekly for the first 8 weeks of~     treatment and then weekly for the remaining 12 weeks of the study. Using feedback from~     clinicians and participants, the investigators will make further modifications to the manual~     in preparation for conducting a larger controlled clinical trial.~   "
161845|NCT01447589|"~     The aim of this clinical trial is to test whether the drug nelfinavir, which can increase the~     effectiveness of radiotherapy, can be given safely at the same time as a full dose of~     radiotherapy for lung cancer.~      It is thought that one way that nelfinavir works is through causing changes in the blood~     vessels within tumours. The status of tumour blood vessels and the blood flow through them~     will be investigated during the trial using special imaging techniques. The dose of radiation~     used in this trial is greater than that used in previous trials with nelfinavir in other~     disease settings and the response of normal lung to the combination of nelfinavir plus~     radiation is unknown. Therefore, a low dose of nelfinavir will be given to the first few~     patients that participate and will be gradually increased in subsequent groups of patients~     provided that no worrying side effects are identified. There is a single report of serious~     side-effects in an AIDs patient who was treated with radiotherapy for lung cancer when he was~     also taking nelfinavir. However, in this case nelfinavir was taken at a dose 3-fold higher~     than the highest dose level to be tested in this trial. An important goal of this trial is to~     select the optimum dose of nelfinavir to be used in combination with lung radiotherapy, that~     can then be tested more extensively in future trials.~      The radiotherapy treatment in this trial has been carefully designed to minimise the amount~     of healthy lung that receives radiation. Some specialised imaging techniques will be used~     during radiotherapy planning and delivery to help ensure that the lung cancer is targeted~     very precisely by radiation and that normal lung is avoided as much as possible.~      One effect of nelfinavir is to interfere with the function of a particular protein in cells~     (called AKT). The degree to which this happens can be measured in cells from blood or tissue~     samples. Therefore, another aim of the study is to investigate AKT and related proteins, to~     check whether nelfinavir is having the predicted effect.~   "
161846|NCT01447576|"~     The purpose of this study is to assess the long-term safety, tolerability and efficacy of~     oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive~     Disorder (MDD).~   "
161847|NCT01447563|"~     Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet~     activation, is widely used to prevent and reduce the risk of thrombotic events. Objective:~     the aim of the present study is to evaluate the bioequivalence of two oral formulations of 75~     mg clopidogrel tablets. Method: The study is an open, randomized, single-dose, two-period~     crossover trial conducted on 32 healthy Mexican volunteers in a fasted state. A single oral~     dose of the test or reference drug will be followed by a 7 day washout period, after which~     subjects will receive the alternative formulation. Blood samples were collected up to 24 h~     after dosing. In order to determine bioequivalence, the plasma concentrations of clopidogrel~     carboxylic acid metabolite was determined using high-performance liquid chromatography-tandem~     mass spectrometry area under the plasma concentration time curve from zero to the last~     quantifiable level (AUC0-t), area under the plasma concentration time curve extrapolated to~     infinity (AUC0-∞), maximum plasma concentration (Cmax), the plasma elimination half-life~     (Tmax) and plasma half-life (T1/2) were calculated for both formulations.~   "
161848|NCT01447550|"~     This study assessed the effectiveness and safety of bosentan when administered to~     thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was~     designed,included in which patients with ulcer and/or pain at rest were treated with bosentan~     p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated~     to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor~     amputation rate, hemodynamic changes, changes in endothelial function and angiographic~     changes.~      12 patients were included were current smokers. With bosentan treatment, no new ischemic~     lesions were observed in all but one patient. Overall, clinical improvement was observed in~     12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after~     bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic~     resonance image an increase of distal flow was observed in 10 out of the 12 patients. All~     patients experienced a statistically significant improvement in their BAFMD values (means:1.8~     at baseline;6.6 at the end of the treatment;12.7 three months after the end of the~     treatment;p<0.01). In conclusion: Bosentan treatment may result in an improvement of~     clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves~     further investigation in the management TAO patients.~   "
161849|NCT01447537|"~     The investigators conducted a pilot study including 17 patients with liver cirrhosis showing~     that a moderate exercise programme during three months increased thigh circumference,exercise~     tolerance and quality of life without adverse effects. The present study aim to more~     accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory~     response in patients with cirrhosis. This study will include 30 patients with compensated~     liver cirrhosis that will be randomized into two groups: exercise group and control group.~     Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will~     be made at the beginning and at the end of the study.~   "
161850|NCT01447524|"~     Caloric restriction in obese diabetic patients quickly improves glucose control,~     independently from weight loss. However, the early effects of a very-low calorie diet (VLCD)~     on insulin sensitivity and insulin secretion in morbidly obese patients with type 2 diabetes~     are still unclear.~      The objective of this study was to investigate the relative contributions of insulin~     sensitivity and/or secretion to the improvement in glucose metabolism, after one week of~     caloric restriction, in severely obese diabetic patients.~      For this purpose, hyperglycemic clamps were performed in 14 severely obese (BMI> 40 kg/m2)~     patients with type 2 diabetes in good glucose control (HbA1c <7.5%), before and after 7 days~     on VLCD 400 kcal/day.~   "
161865|NCT01447329|"~     The investigators propose to complete a randomized controlled trial to compare ear~     acupuncture at Cingulate gyrus, thalamus, omega 2, shen-men, and point zero on the right and~     left ear plus standard of care versus standard of care alone for symptomatic treatment of~     pain following ambulatory arthroscopic knee surgery. After the subject has been discharged,~     phone calls, emails or text messages will be made at 24 and 48 hours, 1 week and 1 month.~     These contacts will be used to assess the subject's pain level, ambulation status, doses of~     analgesics taken and time to return to full duty. At 1 week and 1 month, subjects will be~     asked the PIQ-6 Pain Impact Questionnaire.~   "
161851|NCT01447511|"~     This research study will help determine how a person's genetic makeup affects their response~     to drugs, the ability of the body to break down drugs, and their potential to experience an~     interaction between drugs. The investigators are investigating the drug interactions with the~     commonly used anticoagulant drug called warfarin. Warfarin is used for the treatment and~     prevention of life-threatening abnormal blood clots such as deep vein thrombosis, heart~     attacks, and strokes. The investigators chose warfarin for this study because it is a~     commonly used drug and must be monitored closely to avoid side effects. The investigators are~     interested in studying whether individuals with certain genetic profiles react differently to~     warfarin when it is combined with other drugs. This research is being done to see if certain~     genetic profiles require us to adjust warfarin doses differently than is needed for the~     general population. Genetic profiles of subjects are determined from their participation in~     the Pharmacogenetics Registry study (investigator Richard Brundage, University of Minnesota).~      The study hypothesis is: Functionally defective CYP2C9 alleles attenuate the~     warfarin-fluconazole inhibitory interaction and exacerbate the warfarin-rifampin inductive~     interaction.~   "
161852|NCT01447498|"~     In a prospective randomised study design to investigate, if a systematic risk factor~     screening for bleeding ulcer in patients, who following percutaneous coronary intervention~     (PCI) commence a one year combination treatment with low dose aspirin and clopidogrel,~     followed by prophylactic treatment with a proton pump inhibitor (PPI) in case of increased~     risk, can reduce the risk of bleeding ulcer. Based on the recently raised suspicion that~     PPI's, possibly except pantoprazole, reduce the effect of ADP-receptor inhibitors,~     pantoprazole has been chosen as prophylaxis in the screening group, and analyses will be done~     to ascertain whether PPI treatment increases the risk of coronary events. Further analyses~     will be made to see whether PPI prophylaxis in high risk patients can increase compliance~     with the antithrombotic treatment through a reduction of side effects, thereby reducing the~     risk of myocardial infarction in particular stent thrombosis. The study population will be~     analyzed further to identify the patients, who will benefit the most from PPI prophylaxis~     Hypothesis: screening heart patients for risk factors for bleeding ulcer and subsequently~     treating high risk patients with PPI can reduce the incidence of bleeding ulcer and increase~     compliance with the antithrombotic treatment; thereby possibly reducing the risk of coronary~     events and improving survival. Initial a description of the prevalence of risk factors will~     be done.~   "
161853|NCT01447485|"~     This study will assess the pharmacokinetics and safety following single dose of valsartan in~     Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.~   "
161854|NCT01447472|"~     The purpose of this study are:~        1. to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and~          caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism~        2. to evaluate gender differences in the human pharmacology of MDMA~        3. to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects~          and pharmacokinetics of MDMA.~   "
161855|NCT01447459|"~     The investigators hypothesize that reinforced asthma education improves long-term outcomes in~     children with asthma.~      Specific Aims and Objectives:~        1. To determine the retention rate of parental knowledge about asthma;~        2. To evaluate the clinical status, quality of life and healthcare costs of children with~          asthma following an educational intervention.~   "
161856|NCT01447446|"~     This prospective, multicenter, observational cohort study will evaluate the efficacy and~     safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and~     treatment regimens containing direct-acting antivirals in participants with chronic hepatitis~     C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be~     collected from participants receiving treatment according to current Summary of Product~     Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week~     follow-up.~   "
161857|NCT01447433|"~     The purpose of the study is to determine whether calcium plus vitamin D supplementation is~     conducive to weight and fat loss during energy restriction in very-low calcium consumers.~   "
161858|NCT01447420|"~     This multi-center, open-label study will evaluate the efficacy and safety of Pegasys~     (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in~     treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys~     (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated~     time of study treatment is 48 weeks, follow-up is 24 weeks.~   "
161859|NCT01447407|"~     This partially-blind, placebo controlled study is a Phase 1b study using an investigational~     vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will~     compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose~     level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID)~     compared to placebo delivered ID.~   "
161860|NCT01447394|"~     The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon~     Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC)~     compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.~   "
161861|NCT01447381|"~     While many patients with atopic dermatitis (eczema) can be managed with topical creams and~     treatments for itch, some children have such severe, long-standing disease that they need~     treatment with oral medications that decrease the ability of the immune system to react.~     However, there is not enough information on the proper use of these medications or how well~     they work compared with each other. The current study looks at the response of children~     treated with these medications to provide this information and improve their use.~   "
161862|NCT01447368|"~     This is a pilot, prospective randomized controlled study with the primary objective to~     evaluate and compare medical treatment of SHPT, namely oral cinacalcet versus surgical~     treatment, that is, parathyroidectomy with forearm autografting, on the progression of~     coronary artery and valvular calcification in endstage renal disease patients over 12 months.~     The change in arterial stiffening and bone mineral density as well as nutritional status will~     be evaluated as secondary objectives of this study.~   "
161863|NCT01447355|"~     This pilot phase I trial studies vitamin D levels in the skin of healthy subjects after oral~     supplementation. Chemoprevention is the use of certain drugs to keep cancer from forming. The~     use of cholecalciferol, a vitamin D, may keep skin cancer from forming.~   "
161868|NCT01447290|"~     This is a non-inferiority, prospective study of the relationship between the 24-hour urine~     protein collection and spot protein:creatinine ratio in the diagnosis of preeclampsia~     involving a sample of 18-45 year-old pregnant women attending the new Obstetrics orientation.~     The investigators will follow all participants who consent to be part of this study~     throughout their entire pregnancy. Those who get evaluated for preeclampsia will then have a~     P:C ratio anytime their Primary Obstetrics provider orders a standard of care 24-hour urine~     collection (standard of care). Those participants who are not evaluated for preeclampsia~     during their pregnancy will be dropped from the study.~      Participants evaluated for preeclampsia during the prenatal period will be asked to provide a~     random spot clean-catch urine sample at intervals of approximately 0 and 24 hours following~     the initiation of the 24-hour urine collection. The patient's demographic and clinical data,~     as well as the spot protein:creatinine ratio and 24-hour urine protein will be collected and~     analyzed at the conclusion of the study period.~   "
161869|NCT01447277|"~     The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block~     only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a~     decrease in opiate consumption, pain scores, post operative nausea/vomiting, and~     post-anesthesia care unit (PACU) length of stay. The investigators are prospectively~     randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.~   "
161870|NCT01447264|"~     The interest in studying the impact of aquatic exercise on muscle strength of patients with~     rheumatoid arthritis came after publication of several studies that pointed to the potential~     benefit of exercise on the natural history of the disease, including reduction of pain,~     better immune response as well as aerobic fitness and functional capacity and increase muscle~     strength, endurance and quality of life.~      In general, the aquatic exercises are indicated for patients with chronic joint diseases,~     since the aquatic environment seems to be more secure for this population due to the~     reduction of joint loading, as well as gain range of motion.~      However, there are some difficulties to show the real and consistent beneficial effect of~     physical activity in these patients, such as the small number of randomized controlled~     clinical trials, short intervention period (4-8 weeks), lack of details of the exercise~     protocols used, methodological problems (heterogeneous measures to evaluate the outcome,~     change of medication). Moreover, no study evaluated the disease activity, according to the~     tool most used clinically worldwide, the DAS28.~      It is known that aquatic exercises without impact in healthy subjects are sufficient to gain~     muscle strength. Nonetheless, in people with joint limitation the benefits from these same~     exercises to gain muscle strength is not known.~      To date, no studies addressing the effect of aquatic exercise on muscle strength and disease~     activity in patients with rheumatoid arthritis. In addition, there is the need to obtain a~     standardized protocol for prescribing of aquatic exercises. The choice of lower-limb strength~     was based on its relevance to the acceleration and deceleration during the march, as well as~     to perform activities of daily living, leisure and professional in these individuals.~      Thus, this study aims at:~        1. Exercises performed in the aquatic environment and without the concomitant use of~          overhead equipment are sufficient to promote gain muscle strength in the lower limb?~        2. What is the isolated effect of water resistance on muscle strength? Could it work as an~          impact that is used in exercises done on the land?~   "
161871|NCT01447251|"~     The investigators plan to recruit 140 patients (35 subjects in each group) over a period of~     18 months in a prospective study of matched/paired case-control subjects across the four~     groups to measure the 5-year risk of developing DM2 in each group and if knowledge of the~     5-year risk of developing diabetes will affect continuous positive airway pressure (CPAP)~     compliance. The study will have four arms: 1) patients who have newly-diagnosed OSA requiring~     CPAP therapy without diabetes and are given the result of the diabetes risk score; 2)~     patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are not~     given the result of the diabetes risk score; 3) age, sex, and BMI-matched controls without~     OSA or diabetes; 4) age, sex, BMI, and OSA severity matched patients on CPAP therapy for OSA.~     The investigators will document that the patients are compliant with CPAP based on review of~     SD card data recorded by the CPAP machine. Each patient will have serum drawn for the~     biomarker panel as well as the standard diagnostic measures of DM2 (oral glucose tolerance~     test (OGTT) upon enrollment in the study. An Epworth Sleepiness Score, BMI, neck and waist~     circumference, smoking history, blood pressure, and other standard vital signs will also be~     collected.~      There will be no follow-up of the study subjects in groups 3 and 4 and their participation in~     this study is completed after Visit 1. Groups 1 and 2 will be followed for 6 months after~     enrollment to assess whether or not there is any change in CPAP compliance as measured by SD~     card.~   "
161872|NCT01447238|"~     The purpose of this study is to assess the yield of combination modalities in the diagnosis~     of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype~     needle based confocal laser-induced endomicroscopy miniprobe (nCLE).~   "
161873|NCT01447225|"~     To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer~     therapies~   "
161874|NCT01447212|"~     The purpose of this study, SALOME, is to determine if 1) the closely supervised provision of~     injectable, hydromorphone (HDM; trade name Dilaudid™) is as effective as injectable~     diacetylmorphine (DAM; heroin) in the treatment of chronic, multi-morbid opioid-dependent~     individuals who have not benefited sufficiently from conventional treatments, and if a switch~     to the oral equivalent of hydromorphone and diacetylmorphine is as effective as the injection~     form. The availability of an effective, licensed opioid medication such as hydromorphone, for~     substitution treatment of chronic, multi-morbid treatment-refractory opioid-dependent~     individuals, would be of immense impact locally and internationally. It could help to~     establish alternative treatment options where for non-medical reasons Heroin Assisted~     Treatment would not be acceptable. Thus, one result could be the expansion of treatment~     options for the most difficult to treat heroin dependent persons. This would also be an~     important step for secondary prevention of HIV and Hepatitis C as well as a better~     integration of those patients in other medical treatments. Switching from intravenous to oral~     application would also reduce a lot of potential risk factors (like overdose, seizures,~     infections, etc) and side effects associated with the injection route. Additionally it could~     make these treatments more feasible in normal treatment settings, like existing methadone~     services.~   "
161875|NCT01447199|"~     The goal of this study is to understand factors which may influence risk for colorectal and~     other cancers in families. These factors include genetic variability, in combination with~     diet and lifestyle. In order to achieve these goals, we need to contact as many eligible~     participants as possible.~   "
161929|NCT01446484|"~     T regulatory cells (T regs) are responsible for immune tolerance in solid organ transplant~     patients. This study will evaluate the treatment of children with kidney transplants either~     with Campath and other immune system suppressing medications alone or in combination with~     injection of autologous CD4+CD25+CD127lowFoxP3+ T regulatory cells expanded ex vivo. The aim~     of this study is to develop a new strategy that will be more effective in preventing organ~     rejection and maintaining patient health.~   "
161876|NCT01447186|"~     Objectives:~      The primary objective of this project is to develop and evaluate a Spanish-language slide set~     for administration in group settings, adapted from the content of the current guidelines and~     existing, self-administered ACS early detection decision aid.~      A guide for educators will accompany the slide set so that materials may be distributed on a~     broad scale at the completion of the project. It is expected that these products will be made~     available to community-based educators and screening programs to be used in support of an IDM~     process for early detection of prostate cancer with Spanish-speaking men.~      Specific Aims:~      To conduct an extensive review of the literature and other resources to identify themes~     related to early detection, concerns and beliefs about prostate cancer in Hispanic men.~     Findings will be used to adapt the slideset.~      To cognitive test the Spanish-language decision aid slide set with Hispanic men To conduct~     focus groups to evaluate the acceptability of the adapted slide set with Spanish-speaking~     Hispanic men who are candidates for prostate cancer screening. Participants will be tested~     for their knowledge of prostate cancer and acceptability of materials (e.g. length, clarity,~     amount and balance of information provided).~   "
161877|NCT01447173|"~     The study looks at how vitamin D supplement will improve the severity of asthma and lung~     function as well as biomarkers in asthmatic children.~   "
161878|NCT01447160|"~     The purpose of this study is to evaluate the effectiveness of facet joint infiltration with~     corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.~   "
161879|NCT01447147|"~     The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B~     in subjects with diabetic nephropathy.~   "
161880|NCT01447134|"~     1. Primary endpoint(s): To determine the relationship between the drug distribution and~          angiogenesis in head and neck cancer patients.~        2. Secondary endpoint(s): To expand the safety database of [F-18]RGD-K5 and to correlate~          the parameters from the image study to clinical treatment response and prognosis.~   "
161881|NCT01447121|"~     This clinical trial is designed to assess an investigational blood glucose monitoring system~     with fingerstick blood in the hands of untrained intended users.~   "
161882|NCT01447108|"~     The Suicide Disease, Trigeminal Neuralgia (TN) is arguably caused by one of the most~     discrete and eloquently reversible central nervous system lesions known to the field of~     neurology.~      Recently Dr Adahan H. and Dr Binshtok A. have completed an open label series of 25 subjects~     with refractory TN showing a remarkable positive response rate to TN's treatment with Low~     Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU).~      The primary objective of this study, therefore, is to determine whether this apparent~     efficacy of Low Intensity Low Frequency Ultrasound (LILFU) in the treatment of TN pain could~     withstand the rigors of an n=1 crossover placebo control study.~      Participants with refractory trigeminal neuralgia pain despite optimized pharmacotherapy for~     at least six months will be screened for participation in the study based on rigorous~     inclusion and exclusion criteria. It is judged rather unlikely that such subjects will~     experience spontaneous regression of their disease in the course of this study.~      Patients meeting the inclusion criteria will be treated with four weeks of a placebo Low~     Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU) device while continuing~     with their pharmaco-analgesic regimen. All patients will be crossed over to active LILF/SAWU~     therapy for the next four weeks. Patients will be blinded to all treatments throughout the~     study. Patients will be instructed to use the device daily overnight, and remove it upon~     wakening. The device is programmed to work in cycles of 30 minutes on and 30 minutes off, for~     a total of six- eight hours of intermittent treatment.~      At the end of the second month of the study, patients will be offered a choice as to whether~     they wished to continue with the current (active) device or go back to the 1st (sham) device.~      Patient's pain severity will be tracked every two weeks over the course of three months.~     Functional health and well being will be monitored at intake, post Placebo period, post~     Active period and at completion of the study.~   "
161883|NCT01447095|"~     The purpose of this study is to determine whether prostacyclin is effective in prevention of~     cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).~   "
161884|NCT01447082|"~     The main objective of this observational study is to characterize new users of quetiapine XR~     as well as new users of other study drugs (i.e. the comparison group) and to quantify the~     risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well~     as in other study drugs.~   "
161885|NCT01447069|"~     The purpose of this study is to determine whether Salbutamol is effective in the treatment of~     severe heart failure due to ischemic and non- ischemic cardiomyopathy.~   "
161886|NCT01447056|"~     Patients have a type of a lymph node cancer called lymphoma, a tumor of the nasal passages~     called nasopharyngeal carcinoma (NPC), a tumor of a particular type of muscle called~     leiomyosarcoma (LMS) or a condition called severe chronic active EBV (SCAEBV) syndrome. The~     disease has come back, may come back or has not gone away after treatment. This voluntary~     research study uses special immune system cells called LMP-specific cytotoxic T lymphocytes,~     a new experimental therapy.~      Some patients with these diseases show evidence of infection with the virus that causes~     infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their~     diagnosis. EBV is found in the cancer cells of up to half of the patients with lymphomas, and~     in some cases of NPC and LMS, suggesting that it may play a role in causing these diseases.~     Those cancer cells (as well as some B cells in SCAEBV) that are infected by EBV are able to~     hide from the body's immune system and escape destruction. We want to see if special white~     blood cells, called T cells, that have been trained to kill cells infected by EBV can survive~     in the blood and affect the tumor.~      This treatment with specially trained T cells has had activity against these viruses when the~     cells are made from patients with those diseases (or, after bone marrow transplant, from the~     patient's transplant donor). However, sometimes it is not possible to grow these cells; other~     times, it may take 2 to 3 months to make the cells, which may be too long when one has an~     active tumor. We are therefore asking if subjects would like to participate in this study,~     which tests if blood cells from a donor that is a partial match with the subject (or the~     transplant donor) that have been grown in the way described above can survive in the blood~     and affect the disease.~      These LMP-specific CTLs are an investigational product not approved by the Food and Drug~     Administration.~   "
161887|NCT01447043|"~     Retrospective, non-interventional, observational multi-center field study. Patients diagnosed~     with wet Age-related macular degeneration (wAMD) and having started treatment with~     ranibizumab between January 1, 2009 and August 31, 2009 must be consecutively screened and,~     if eligible, enrolled. Patients will be followed up at maximum until August 31, 2011. Switch~     to any other Anti vascUlar endothelial growth factor (anti VEGF) treatment will be documented~     and followed up. For each patient, demographics, medical history, administered treatments,~     results of ocular and visual assessments and other tests (where available) will be~     documented.~   "
161888|NCT01447030|"~     Introduction: Bile duct injury (BDI) after cholecystectomy remains a serious complication~     with major implications for patient outcome. For most major BDIs, the recommended method of~     repair is a hepaticojejunostomy (HJ). We conducted a retrospective review from 5 Danish~     hepatobiliary centres aiming to examine the perioperative and the long-term outcome after~     reconstructive HJ.~   "
161889|NCT01447017|"~     The primary objective of this study is to evaluate safety and tolerability of DPK-060 2% ear~     drops compared to placebo for DPK-060 ear drops in patients with acute external otitis. The~     secondary objectives are to evaluate clinical cure and microbiological growth following~     treatment with DPK-060 2% ear drops compared to placebo for DPK-060 ear drops.~   "
161891|NCT01446991|"~     This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing~     Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate~     brachytherapy. There are 2 eligible populations of men, all of whom will have selected~     brachytherapy as their treatment of choice for their prostate cancer. Either they have an~     enlarged prostate that requires size reduction to render brachytherapy technically feasible,~     or they require androgen ablation in conjunction with brachytherapy for optimal tumor~     control. The hypothesis is that Degarelix will provide > 30% volume reduction by 3 months in~     > 30% of men.~   "
161892|NCT01446978|"~     Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability~     to induce protective immunity in immunosuppressed travelers are scarce. The investigators~     assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis~     (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).~      In a previous study, 2 doses were not considered effective and there is therefore need for a~     study with an additional dose~   "
161893|NCT01446965|"~     This study explores the hypothesis that wearable defibrillators can impact mortality by~     reducing sudden death during the first three months after a heart attack in persons with high~     risk for life-threatening arrhythmias.~   "
161894|NCT01446952|"~     This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol~     in subjects with resectable pancreatic tumors.~   "
161895|NCT01446939|"~     Parkinson´s disease (PD) diagnosis is based upon clinical examination. Although imaging has~     helped doctors to identify many diseases, it still does not add too much information for the~     diagnosis of Parkinson´s disease. The investigators are going to perform a large sample study~     including PD patients, essential tremor and healthy volunteers in order to evaluate if MRI~     can help in the diagnosis. Our hypothesis is that fractional anisotropy (FA) in the caudal~     portion of substantia nigra is decreased in PD patients.~   "
161896|NCT01446926|"~     This study is designed to explore the safety and tolerability of an investigational~     pneumococcal vaccine through a step-down enrollment.~      Primary Objective:~        -  To evaluate the safety and tolerability of an investigational pneumococcal vaccine.~      Secondary Objective:~        -  To evaluate the immunogenicity of an investigational pneumococcal vaccine.~   "
161897|NCT01446913|"~     The goal of this study is to develop a novel study design to safely and ethically conduct a~     long-term randomized controlled trial among patients at high risk for both sleep apnea and~     cardiovascular events that will examine whether effective positive airway pressure(PAP)~     therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke~     have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular~     events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular~     death)in the first year post event, despite current prevent strategies. Therefore, the~     treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular~     outcomes in this high risk population.~   "
161898|NCT01446900|"~     The objective of this study is to confirm the efficacy of the association of R-2cda in~     patients affected by Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma and of~     evaluating the efficacy of prolongation of therapy with additional infusions of Rituximab~     alone in increasing and prolonging the duration of the response.~   "
161899|NCT01446887|"~     Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It~     remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A~     randomized double-blind study was conducted to determine whether prophylactic anticoagulation~     was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to~     prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were~     followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator~     also used logistic regression analysis with variable selection for obtaining the prediction~     model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical~     compression, duration of surgery). THA with short duration of surgery did not require~     prophylactic anticoagulation.~   "
161900|NCT01446874|"~     Postoperative pneumonia is a major complication in patients undergoing thoracic surgery. It~     leads to considerable morbidity and contributes to perioperative morbidity. There is evidence~     in literature that supports the use of strategies for improved oral hygiene and specialized~     endotracheal tubes in preventing ventilator associated pneumonia (VAP) in mechanically~     ventilated patients. This study aims at utilizing a combination of these interventions in the~     perioperative period in patients undergoing planned thoracic surgical procedures.~   "
161901|NCT01446861|"~     Purpose The purpose of this study is to develop and validate multimodal testing of exocrine~     pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in~     patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be~     correlated to age group, genotype, nutritional status and quality of life. Earlier detection~     of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of~     therapeutically benefit.~      Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine~     pancreatic function in patients with cystic fibrosis.~      New functional testing of exocrine pancreatic function is superior to traditional testing~     with fecal elastase.~      MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients.~      Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and~     parenchymal changes in cystic fibrosis patients.~      Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and~     development of hepatocellular carcinoma in the liver of cystic fibrosis patients.~      Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in~     duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with~     exocrine pancreatic function.~   "
161902|NCT01446848|"~     The purpose of this study is to investigate the effects of iron supplementation in patients~     with pulmonary arterial hypertension and iron deficiency.~   "
161903|NCT01446835|"~     The purpose of this study is to compare the cosmetic appearance of two different contact~     lenses on Asian eyes.~   "
162013|NCT01445301|"~     This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled~     (clindamycin [CLDM] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to~     demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide [BPO] 3% gel) when applied~     once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when~     applied topically either once or twice daily for 12 weeks.~   "
161904|NCT01446822|"~     This is a single-center, prospective, randomized, controlled trial comparing two established~     transurethral electrical resection methods of urinary bladder tumors regarding their risk of~     stimulating the obturator nerve.~      One of the major safety issues with transurethral resection is bladder perforation as a~     consequence of obturator nerve stimulation followed by muscle contraction of. This is mostly~     a risk of resection of lateral bladder wall tumors near the course of the obturator nerve. It~     has been advocated that bipolar may be superior to monopolar resection, based on its~     different electrical properties. This is an important safety aspect for the patient.~      Main study question: In patients with lateral wall urinary bladder tumors, is bipolar~     superior to monopolar transurethral electroresection regarding risk of stimulation of the~     obturator nerve without preoperative nerve block?~   "
161905|NCT01446809|"~     This randomized pilot clinical trial studies pazopanib hydrochloride followed by chemotherapy~     and surgery in treating patients with soft tissue sarcoma. Pazopanib hydrochloride may stop~     the growth of tumor cells by blocking some of the enzymes that are needed for cell growth and~     may also stop the growth of soft tissue sarcoma by blocking blood flow to the tumor. Giving~     pazopanib hydrochloride and chemotherapy before surgery may make the tumor smaller and reduce~     the amount of tissue that needs to be removed.~   "
161906|NCT01446796|"~     Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left~     ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart~     failure. However, little is known about RV pacing in patients with advanced heart failure~     treated with an implantable left ventricular assist device (LVAD). The univentricular support~     provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart~     failure patients, yet the incidence of RV failure in the early post-operative period~     following implantation is associated with significantly reduced survival and increased length~     of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size~     that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing~     may counteract these adverse mechanical alterations, improving RV systolic function and~     ultimately LVAD function.~      The investigators will recruit all patients referred for an implantable, continuous flow LVAD~     at Duke University Medical Center who have an existing implantable dual-chamber~     cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to~     compare continuous right ventricular pacing vs. native ventricular conduction at equivalent~     heart rates. Multiple clinical outcomes will be examined over a two week period~     post-operatively including invasive hemodynamics, vasoactive medication use, end-organ~     function, RV function by Echocardiography as well as patient symptoms and functional status.~   "
161907|NCT01446783|"~     The investigators want to inject insulin-like growth factor-I (IGF-I) into the patella tendon~     of Ehlers-Danlos patients and healthy controls to evaluate the response in collagen~     synthesis. Furthermore collagen synthesis is measured in muscle connective tissue and in~     skin.~      The hypothesis is that the connective tissue in Ehlers-Danlos patients is more compliant and~     poorer in collagen than healthy controls, but that collagen synthesis can be stimulated by~     IGF-I.~   "
161908|NCT01446770|"~     The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a~     hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated~     with keloid scarring in subjects undergoing surgical revision of keloid scars.~   "
161909|NCT01446757|"~     The main purpose of this randomised controlled trial is to study if a Comprehensive Geriatric~     Assessment (CGA) and follow up for community-dwelling elderly people can improve outcomes~     such as health and health-related quality of life among both patients and relatives, feeling~     of safety among both patients and relatives and reduce costs, compared with usual care.~   "
161910|NCT01446744|"~     Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers~     high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique~     can potentially allow radiation treatments to be focused more precisely, and delivered more~     accurately than with older treatments. This improvement could help by reducing side effects~     and by improving the chance of controlling the cancer by more precisely treating the cancer.~     The purpose of this study is to compare SABR with current approaches of chemotherapy and~     conventional radiotherapy to assess the impact on overall survival and quality of life.~   "
161911|NCT01446731|"~     This is a randomized phase II trial including 40 patients with castration resistant~     metastatic cancer prostate (CRMPC).~      Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel~     and docetaxel alone.~      The primary objective is to evaluate the vaccine specific immune response and patients will~     be evlauated with blood tests and DTH reactions during the treatment course.~      Secondary objectives are to evaluate clinical response by objective response~     (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine~     time to progression and overall survival.~   "
161912|NCT01446718|"~     The purpose of this study is to determine sustained immunogenicity of the quadrivalent~     vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls~     age 9-14 years. This age range is within the World Health Organization (WHO) stipulated~     guidelines for national programs for the vaccine.~   "
161930|NCT01446471|"~     The aim of this study is to investigate the predictive value of the presence or absence of~     cardiac activity by bedside ultrasound during cardiac arrest. The investigators anticipate~     based on previous research that patients who suffer a cardiac arrest and have cardiac~     activity on bedside ultrasound will have a greater chance of surviving to hospital admission.~     The investigators hypothesis is that the mortality rate in patients in cardiac arrest with no~     cardiac activity by ultrasound will have a mortality rate of 100%.~   "
161965|NCT01446016|"~     The major purpose of this research study is to better understand how therapy works on~     different patients. This study is being offered to patients with a diagnosis of advanced or~     metastatic breast cancer who have failed anthracycline based therapy.~      The investigators want to see the response of breast cancer cell when treated with~     Chloroquine used in combination with chemotherapy. Chemotherapy is an anti-cancer drug that~     is given through your vein. The chemotherapy used in this study is either Taxane (Paclitaxel)~     or Taxane-like drugs (Abraxane, Ixabepilone or Docetaxel).~   "
162040|NCT01444885|"~     The objective of this study is to investigate the efficacy and safety of Pletaal (Cilostazol)~     in comparison with placebo for 4 weeks in vasospastic angina patients who have an~     insufficient response to Amlodipine (Calcium channel blocker).~   "
161913|NCT01446705|"~     Three out of four Veterans receive a portion of their care from non-VA providers. On April 9,~     2009, President Barack Obama directed the Department of Veterans Affairs and the Department~     of Defense to create the Virtual Lifetime Electronic Record (VLER). On August 2010, Secretary~     of Veterans Affairs Eric K. Shinseki visited Indianapolis, and after visiting with leaders~     from the VA Health Services Research & Development (HSR&D) Center of Excellence and the~     Regenstrief Institute, he made the following public comments regarding the latest partnership~     between the two institutions: This new technology allows safer, more secure, and private~     access to electronic health information which, in turn, enhances our ability to continue~     providing Veterans with the quality care that they have earned.~      This new technology refers to the VLER HEALTH program that the Indianapolis VA is now~     implementing in partnership with the Regenstrief Institute and Indiana Health Information~     Exchange (IHIE). This VA-IHIE demonstration project is intended to create the capacity for VA~     institutions to exchange health information with community partners.~      Investigators from the VA HSR&D Center on Implementing Evidence-Based Practice are active~     collaborators in building and implementing this program. The VA-IHIE program provides the~     bi-directional exchange of health information between VA and non-VA providers. Based on our~     pilot study of linked VA-IHIE data, investigators are conducting an evaluation of the impact~     of the VA-IHIE demonstration project upon health care quality and cost of Veterans by taking~     advantage of the initiation of the implementation as a natural experiment.~   "
161914|NCT01446692|"~     A retrospective study using a data base of anonymized medical records. The purpose of the~     study is to examine the different therapeutic strategies for the management of patients with~     major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary~     care~   "
161915|NCT01446679|"~     This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve~     the category-specific targeted lipid levels.~   "
161916|NCT01446666|"~     Current practice guidelines recommend surveillance for hepatocellular carcinoma (HCC) in~     liver cirrhosis patients with ultrasonography (USG) every 6 months. However, with the~     advancement of cirrhosis, the sensitivity of USG decreases, while the risk for HCC increases.~     Gadoxetic acid (Primovist®)-enhanced magnetic resonance imaging (MRI) has been demonstrated~     to be of clinical value for diagnosis of HCC with the detection sensitivity of 90-95%, which~     is significantly higher than USG. The hypothesis to be proved by this study is as follows;~     Primovist-MRI should show significantly higher sensitivity compared to USG for the detection~     of early stage HCC when both of these imaging modalities are used with the interval of 6~     months in patients with cirrhosis at high risk of developing HCC.~   "
161917|NCT01446653|"~     The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive~     intervention against one comparison and one control condition. Because prevention of~     Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR~     contraception, the primary endpoints will be rates of risky drinking and ineffective~     contraception at six-month follow-up, in addition to dichotomously defined successful~     outcome that will be observed whenever a woman has sufficiently altered one or both of the~     behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify~     a transferable intervention that effectively reduces behaviors that put women at risk for AEP~     and alcohol-related birth defects including FASD.~   "
161918|NCT01446640|"~     The study is a phase I/II trial designed to establish the safety and efficacy of intravenous~     combined with intrathecal administration of autologous bone marrow derived mesenchymal stem~     cells to patients with spinal cord injury.~   "
161919|NCT01446627|"~     The purpose of this study is to evaluate the incidence of wound breakdown or wound infection~     following skin closure with Insorb subcuticular absorbable staples versus metal staples after~     cesarean section through a retrospective chart analysis.~   "
161920|NCT01446614|"~     The study is a phase I/II trial designed to establish the safety and efficacy of intravenous~     administration of autologous bone marrow derived mesenchymal stem cells to patients with~     Parkinson's disease.~   "
161921|NCT01446601|"~     The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve~     stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential~     therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that~     have failed or do not tolerate positive airway pressure (PAP) therapy.~   "
161922|NCT01446588|"~     The investigators aim to pilot test the efficacy of a yoga intervention designed specifically~     for individuals with ocular hypertension. The investigators would like to find out if a~     combination of breathing, postures and meditation may help to reduce intraocular pressure in~     the short term after each yoga session, and also long-term across an 8-week program. Subjects~     will participate in the yoga intervention sessions led by Dr. Pamela Jeter once a week at the~     investigators center, and will be asked to practice at home at least twice a week using a~     audio CD.~   "
161923|NCT01446562|"~     The primary objective of this study is to establish in a prospective phase II study the~     efficacy of 90Yttrium ibritumomab tiuxetan (90Y-RIT) after first line induction~     immuno-chemotherapy with R-CHOP in patients with high-risk advanced stage follicular~     non-Hodgkin's lymphoma, as assessed by the complete response rate.~   "
161924|NCT01446549|"~     The purpose of this study is (1) to provide quantitative information of the motor~     manifestations of Parkinson's disease and (2) to quantify the effect of high intensive~     antigravity locomotor exercise or Deep Brain Stimulation implantations in Parkinson's~     disease.~   "
161925|NCT01446536|"~     Hypothesis: Quality Improvement tools like Heart Failure Discharge Checklist which~     emphasizes on proper education to patients, ensure appropriate dose titration and counselling~     improve outcome in congestive heart failure (CHF).~   "
161926|NCT01446523|"~     The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic~     Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal~     hepatic encephalopathy.~   "
161927|NCT01446510|"~     A systematic review and meta analysis will be performed of risk assessment models for Venous~     thromboembolism (VTE including pulmonary embolism PE and deep venous thrombosis DVT)in~     hospitalized medical patients. The goal of this study is to evaluate whether the incidence of~     VTE is lower in patients that are evaluated with a risk assessment model and treated with~     thromboprophylaxis for their assigned level of risk.~   "
161931|NCT01446458|"~     The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and~     Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic~     cancer is safe and well tolerated. This study will obtain preliminary data on the response of~     the cancer to this therapy by Magnetic Resonance Imaging (MRI) and by studying the cancer~     after it is resected surgically.~      In addition, the investigators will perform biochemical studies on the tumor tissue obtained~     from your tissue biopsy as well as from the tumor removed by the surgeon in order to measure~     the effect of treatment with FOLFIRINOX and SBRT on several proteins that may be important in~     the behavior of pancreatic cancer cells.~      The data obtained from this trial will be extremely valuable to help improve the approach to~     treating pancreatic cancer in the future. If you do not undergo surgery after completion of~     FOLFIRINOX + SBRT, the investigators will request a second biopsy of the tumor under computer~     tomography (CT) -guidance in order to measure the effect of treatment on your tumor.~   "
161932|NCT01446445|"~     The objective of the present study is to optimize intravenous ganciclovir(GCV) and oral~     valganciclovir (VGCV)doses, advised by the drug exposure, indicated by the area under the~     concentration time curve (AUC), in renal transplant patients receiving oral VGCV or~     intravenous GCV for CMV prophylaxis or treatment. The initial doses will be calculated~     according to population pharmacokinetic model. Subsequent doses will be adjusted according to~     plasma GCV concentrations, using the Bayesian approach. This method of dose adjustments could~     lead to increase the percentage of patients achieving a therapeutic exposure.~   "
161933|NCT01446432|"~     A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective~     is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are~     standard and validated questionnaire instruments used to measure health related quality of~     life and function, they do not address patient specific issues. The investigators will also~     pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's~     Disease.~   "
161934|NCT01446419|"~     To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve~     Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain.~     This is a prospective, double-blind, randomized, sham-controlled clinical trial with an~     optional crossover component.~   "
161935|NCT01446406|"~     Bipolar disorder is associated with a high risk of relapse and hospitalisation and many~     patients do not recover to previous psychosocial function. Major reasons for poor outcome are~     delayed intervention for prodromal depressive and manic episodes as well as decreased~     adherence with treatment. Recently, electronic self monitoring of affective symptoms using~     cell phones to prompt patients to respond to weekly text messages has been suggested as an~     easy and cheap way to identify early signs of affective episodes. Nevertheless, so far the~     electronic devises has been rather simple not including a bi-directional feed back loop~     between patients and providers and without electronic data on objective measures of the~     affective psychopathology. As part of an ongoing EU research program a software program for~     online electronic self-monitoring using a cell phone is being developed including an~     interactive feed back loop between patients, relatives and clinicians. Electronic~     self-monitoring includes subjective items such as mood, irritability, sleep duration,~     activity, alcohol consumption, medication intake and objective items of speech duration (on~     the cell phone), social activity (numbers of calls and SMS'es at the cell phone) and physical~     activity (acceleration of the cell phone). The present PhD. study will in a randomized~     controlled single blind trial including 60 patients with bipolar disorder allocated to using~     the active cell phone program (intervention group) or to using a cell phone to usual~     communication (control group) during a 6 months study period.~      If the cell phone self-monitoring system is proved effective in preventing mood symptoms and~     improving psychosocial functioning,quality of life etc. in the present study there might be~     basis for extending the use of the system to treatment of patients with bipolar disorder in~     clinical practice in general.~   "
161936|NCT01446393|"~     To determine the specific structural and functional features of the peripheral arteriopathy~     in the Pseudoxanthoma Elasticum (PXE), an inherited autosomal disease.~   "
161937|NCT01446380|"~     The cohort is intended to study the phenotypic expressions of the pseudoxanthoma elasticum~     (PXE) disease in various tissues (eye, skin, arteries, etc).~   "
161938|NCT01446367|"~     The purpose of this study is to evaluate the corneal changes after performing 20 gauge~     vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal~     detachment.~   "
161939|NCT01446354|"~     Cardiac surgery including hypothermic cardiac arrest (HCA) commonly involves perioperative~     transfusion of allogeneic blood products which is associated with increased morbidity and~     mortality. In this retrospective analysis, the investigator aimed to evaluate the effect of a~     thromboelastometry-guided treatment algorithm promoting fibrinogen concentrate as first line~     hemostatic agent on the perioperative use of allogeneic blood products.~   "
161940|NCT01446341|"~     Acute, severe lateral ankle sprains are estimated to comprise between 3-5% of emergency~     department visits and are the most common musculoskeletal injury in the physically active~     population. Although the current accepted treatment of ankle sprains is to encourage early~     mobilization with functional rehabilitation, there is little high-quality evidence directing~     this clinical practice.~      This pilot study is to:~        -  provide quantitative data for estimation of mean outcome scores and standard deviations~          to allow subsequent sample size calculations~        -  evaluate the feasibility of the proposed study design~        -  assess patient enrollment issues specific to randomization into an active rehabilitation~          program compared to below knee immobilization.~   "
161941|NCT01446328|"~     In the Bergen Psychosis Project 2 the antipsychotic drugs aripiprazole, amisulpride, and~     olanzapine will be compared head-to-head in patients with schizophrenia and related psychoses~     and followed for 12 months. The study is independent of the pharmaceutical industry, and in~     accordance with a pragmatic design a clinically relevant sample will be included with as few~     exclusion criteria as possible. The patients will be assessed repeatedly with regards to~     symptoms, side effects, and cognitive functioning, as well as laboratory parameters. The~     study hypothesis is that clinically meaningful differences among the drugs will be disclosed~     in a pragmatic design.~   "
161964|NCT01446029|"~     The purpose of this study is to determine if the adoption of a chronic care model in~     conjunction with tele monitoring and case management can reduce the risk of death,~     hospitalization, emergency room visits, or admission to a skilled nursing facility in~     patients with chronic kidney disease compared to usual care.~   "
161966|NCT01446003|"~     This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic~     blood pressure in participants with mild to moderate hypertension in addition to safety and~     tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure~     to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood~     pressure change from baseline after 10 days of dosing.~   "
161942|NCT01446315|"~     Asthma is a common problem among US adults and children. Unfortunately many people with~     asthma continue to suffer from asthma symptoms that could be control with better asthma care~     and more attention to details such as triggers, and adherence. To date the only tools~     available and recommended by groups such as the national asthma guideline group consider only~     asthma burden and do not include information on the most common factors that adversely affect~     asthma control. This study provides one half of the enrolled primary care offices with the~     Asthma APGAR which is a system of patient completed questions and a care flow sheet. The~     other half of the enrolled practices will continue to provide usual care without the~     support of the Asthma APGAR system. The research questions is whether or not asthma control~     and asthma related quality of life will be improved in people with asthma who are cared for~     in the intervention practices that use the Asthma APGAR system.~   "
161943|NCT01446302|"~     The objective of this study is to characterize the hormonal and inflammatory responses to~     hemodialysis, and to determine the effect of a meal versus fast on the metabolic changes in~     the post-dialytic phase.~   "
161944|NCT01446289|"~     The study investigated the immune response induced by the Group B streptococcus vaccine in~     healthy pregnant women. In addition, the study investigated the amount of vaccine induced~     antibodies which were transferred to the newborn.~   "
161945|NCT01446276|"~     The purpose of this study is to investigate potential metabolic effects of resveratrol in~     obese healthy men with non-alcoholic fatty liver disease.~      The investigators hypothesize that resveratrol will:~        -  decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion~        -  decrease liver fat content~        -  increase insulin sensitivity~      The investigators will look at changes in:~        -  lipid turnover (VLDL-TG kinetics, palmitate kinetics, indirect calorimetry)~        -  liver fat content (MR liver spectroscopy)~        -  insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)~        -  body composition (DXA and MRI)~        -  lipase activity and fat cell size (fat biopsy from abdominal and femoral adipose tissue)~   "
161946|NCT01446263|"~     Increased use of radial access for cardiac catheterization is being advocated because studies~     have showed lower arterial access related complication rates and higher patient satisfaction~     as compared to femoral access. However, little is known on patients with prior coronary~     artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial proposed~     to test the hypothesis that bypass graft angiography and intervention via radial access~     provides lower vascular complication rates, similar contrast and equipment utilization and~     higher patient satisfaction when compared with transfemoral approach.~   "
161947|NCT01446250|"~     This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC),~     each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American~     participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1~     infection.~   "
161948|NCT01446237|"~     This study is being conducted to obtain safety, efficacy, and satisfaction data on the~     combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent~     Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate~     or severe acne will be asked to apply the commercially available, over-the-counter products~     Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating~     Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included.~   "
161949|NCT01446224|"~     This observational study is conducted as part of a systematic pharmacovigilance activity, to~     provide a population-based context for Pazopanib use outside of the clinical trial setting.~     The aims of the study are to examine the incidence of cardiovascular ischemia (including~     myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular~     accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients~     treated with marketed anti-VEGF agents [Pazopanib (VOTRIENT), Bevacizumab (AVASTIN),~     Sorafenib (NEXAVAR), and Sunitinib (SUTENT)].~      Two databases will be utilized for this study: a large healthcare claims database in the U.S.~     and the Dutch linked medical registries (PHARMO RLS). The databases will provide large,~     geographically varied, non-trial populations in which to examine the incidence of the stated~     cardiovascular ischemic events and Torsades des Pointes.~   "
161950|NCT01446211|"~     The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared~     to conventional treatment in patients with a relapse of Wegener Granulomatosis with or~     without ongoing steroids, and/or immunosuppressive therapy. Further, to evaluate the safety~     and quality of life of gusperimus treatment compared to standard treatment in patients with~     relapse of Wegener Granulomatosis receiving glucocorticoids.~   "
161951|NCT01446198|"~     The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is~     comparable to performance on the TIGRIS System.~   "
161952|NCT01446185|"~     Primary objective:~      Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation~     made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or~     pN1(mi), Her2- breast cancer adjuvant population.~      The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment~     intensity defined as a change in treatment recommendation from chemotherapy plus hormonal~     therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement~     from hormonal therapy alone to the addition of chemotherapy to hormonal therapy.~      Patients with HR+, N- breast cancer currently represent around 70% of newly diagnosed breast~     cancers. These are usually good prognosis tumors. However, on the basis of classical clinical~     and pathological prognostic parameters and markers, the international consensus guidelines~     recommend treatment with hormone- and chemotherapy in 85-95% of the cases. Considering the~     natural disease history, such as documented by the EBCTCG meta-analysis, more than 50% of~     these patients are overtreated, which leads to unnecessary side effects and costs to the~     health system and to the society.~      Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR+, N-~     patients and is performed on fixed paraffin embedded tissue (FPET). It is therefore best~     adapted to daily clinical practice as it does not necessitate any specific surgical procedure~     or tissue freezing.~      The prognostic and predictive value of Oncotype DX in ER+, N- patients has been validated on~     three large adjuvant randomized trials (NASBP B-14, NSABP B-20, and the ATAC study). The test~     has been commercially available in the USA since 2004, and is being used for more than 50% of~     the HR+ N- patients in this country.~      While Oncotype DX has been validated in the USA, it needs to be independently evaluated in~     France, in the context of the local treatment guidelines and habits, to provide data that are~     meaningful to the French health system and to the French medical community.~   "
162041|NCT01444872|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal~     dysfunction.~   "
162042|NCT01444859|"~     Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev~     Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent~     gastrointestinal symptoms.~   "
161953|NCT01446172|"~     While cognitive therapy and exposure therapy are both proven to be effective for panic~     disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould~     et al., 1995) the scientific knowledge about long-term course of these disorders is still~     scanty. Although several long-term outcome studies have been conducted, the quality of these~     studies has been questioned.~      The aim is to conduct a follow-up study of patients with either panic disorder with history~     of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in~     a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be included~     in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive~     and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 - 1993) were~     allocated to either cognitive therapy or guided mastery treatment. Subsample 4 (45 patients~     treated in 1994 - 1996) received cognitive and schema focused therapy.~      In the follow-up study the participants will be requested to complete the same self report~     measures as they completed at intake, discharge and at previous follow-up times. the~     participants will also be interviewed using the SCID-I and II as they were at the previous~     assessments.~      The present sample is relatively unique in having received pure psychosocial experimental~     treatments. The very long term efficacy of cognitive therapy relative to behavioural~     treatmetns for agoraphobia can be evaluated, and the potential moderating effects of~     personality disorders can be assessed.~   "
161954|NCT01446159|"~     Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573~     in combination with an AI in adult subjects with HR+, HER2-negative MBC.~   "
161955|NCT01446146|"~     The purpose of this program is to compare two different methods of matching a Veteran to a~     PTSD treatment.~   "
161956|NCT01446133|"~     The goal of this clinical research study is to learn if the combination of lenalidomide and~     rituximab can help to control CLL. The safety of this drug combination will also be studied.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~      Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to~     die.~   "
161957|NCT01446120|"~     This study is assessing the pharmacokinetics efficacy and of Insulin loaded Orally Dissolved~     Films (insulin-ODF) treatment. The Insulin-ODF is attached to the inner tissue of the chick~     (buccal) , Releasing the insulin to the circulation, while the film is dissolved..~      Primary endpoint:~        1. The Cmax (Maximum Concentration of insulin in mg).~        2. Tmax (the time to Cmax in minutes)~        3. AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.~      Secondary endpoints:~        1. The glucose and C-peptide levels during six hours of the trial. (mg)~        2. The safety of the treatment in a descriptive manner by recording all adverse events in~          the study population.~      Methods~      Seven healthy volunteers will be randomly assigned to one of the following groups:~      A. Insulin-ODF following treatment group; Or B. commercial NPH Insulin treatment.~      The study is designed a crossover, in which each group is treated 3-7 days of washout.~      The volunteer subjects will arrive to the clinic after eight hours fasting. Each subject will~     be examined by a physician, evaluating the elegibilities to the trial (i.e. inclusion and~     exclusion criteria).~      An I.V catheter will be administrated assessing the Glucose, Insulin and C-peptide levels,~     ten minutes and five minutes before injecting the NPH Insulin or the Insulin-ODF.~      Blood Insulin and glucose levels will be evaluated at baseline, and after the following time~     points: 15,30,60,90,120,150,180,210,240,270,300,330,360 minutes. C-peptide levels will be~     evaluated at baseline and after the following time points: 60,120,240, 360 minutes.~   "
161958|NCT01446107|"~     Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of~     the lesions are in the fissures of the first permanent molars. This study aims to investigate~     the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese~     children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride~     solution. The cost-effectiveness of these methods will also be compared. About 400 children,~     aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted~     in school using portable dental lights and instruments to identify teeth that need caries~     prevention. The children will be randomly allocated to one of the three test or the control~     groups. Treatments will be provided in the study primary schools according to standard~     clinical protocols. Follow-up examinations will be carried out every six months for 30 months~     to assess whether the preventive methods are successful, i.e. no dental caries develops in~     the treated teeth. The findings of this study will be of great value to dentists and public~     health authorities in deciding on the most appropriate dental caries prevention programme for~     school children in China and other developing countries.~   "
161959|NCT01446094|"~     This study is designed to evaluate the feasibility and diagnostic performance of a novel~     rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.~   "
161960|NCT01446081|"~     Reduced quality of life, fatigue, and loss of physical function are common in patients~     getting chemotherapy for acute myeloid leukaemia (AML). The investigators completed a pilot~     study showing that exercise during active chemotherapy for AML is feasible, safe, and may~     improve symptoms and physical function. The investigators now propose to compare our~     hospital-based supervised exercise program to usual care to see if exercise can improve~     symptoms, physical function, and improve treatment tolerability.~   "
161961|NCT01446068|"~     The purpose of this study is to quantify the systemic inflammatory and metabolic response of~     lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.~   "
161962|NCT01446055|"~     Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb~     ischemia has been proved safe and effective. However, processing bone marrow by Ficoll~     density gradient centrifugation is not only time consuming but also expensive. Manually~     processing of bone marrow also results in large variation in therapeutic cell quantity and~     quality which directly leads deviation of safety and efficacy of the cell therapy. This study~     is aiming to compare an automated bone marrow processing system with a conventional manual~     method in term of safety and efficacy.~   "
161963|NCT01446042|"~     The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile~     of testosterone) and safety of TBS-1 in the treatment of hypogonadal men~   "
161967|NCT01445990|"~     Evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments~     diagnosis in free tissue transfers is realized.~      These measures are done after surgical reconstructions with free tissue flap, simultaneously~     with clinical examination. These biological data aren't available to make clinical diagnosis~     of complication; only clinical examination is allowed in this way.~      A posteriori, clinical and biological parameters will be compared in order to determine if~     capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps~     monitoring.~   "
161968|NCT01445977|"~     This study is designed to collect data about the SoundBite™ Hearing System to answer specific~     questions. The hearing system has been cleared for commercial distribution by the Food and~     Drug Administration (FDA). Sonitus hopes to learn from a larger group of users what features~     and settings of this device provide the best hearing ability for people diagnosed with Single~     Sided Deafness (SSD) or Conductive Hearing Loss (CHL).~   "
161969|NCT01445964|"~     An open-label, single-dose, three-treatment, three-period study to investigate the effect of~     SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in~     healthy male Korean.~   "
161970|NCT01445951|"~     Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of~     TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination~     with a basal insulin~   "
161971|NCT01445938|"~     Primary Objective:~      To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite~     reduction ratio at 72 hours in pediatric patients with uncomplicated malaria~      Secondary Objectives:~        -  To assess the evolution of clinical signs and symptoms (including the need for a rescue~          therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with~          reference to Artemisinin-Based Combination Therapy (ACTs)~        -  To assess the pharmacokinetics profile of SAR97276A in pediatric patients with~          uncomplicated malaria~        -  To assess the safety profile of SAR97276A in pediatric patients with uncomplicated~          malaria~        -  To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A~   "
161972|NCT01445925|"~     The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by~     radiofrequency ablation would improve single procedure success rates for Radio Frequency~     Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term~     peri-procedural anti-arrhythmic drug therapy alone.~   "
161973|NCT01445899|"~     This is a two-part study. The first part (Stratum I) is an open-label, dose escalation,~     safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be~     given to all patients who participate. Stratum I will determine the maximum tolerated dose~     and any dose-limiting toxicities. The second part (Stratum II) is a prospectively randomized,~     multi-center, double-masked, dose ranging study evaluating the efficacy and safety of~     PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in patients~     with DME.~   "
161974|NCT01445886|"~     The purpose of this study is to compare the efficacy and safety of indigo naturalis oil~     extract and calcipotriol solution in the treatment of psoriatic nails, to show that indigo~     naturalis oil extract may be a good choice for treating nail psoriasis, and potentially an~     effective alternative for those who do not respond well to traditional therapy.~   "
161975|NCT01445873|"~     The objectives of this study are to develop research methods and corresponding materials for~     a study of the effectiveness of sitaxentan sodium (Thelin) in real-world settings; to pilot~     test these methods at three study centers in Europe; and to refine and finalize research~     methods and corresponding materials for possible use in a follow-on, full-scale examination~     of the effectiveness of sitaxentan sodium (Thelin) in real-world settings.~   "
161976|NCT01445860|"~     The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on~     the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.~   "
161977|NCT01445847|"~     In the literature, we found no randomized clinical trials addressing the using of IV~     lidocaine as prophylaxis for postoperative laryngospasm among adults.~      The aim of this study was to assess the effects of IV lidocaine on the incidence of~     postoperative laryngospasm of adults patients.~   "
161978|NCT01445834|"~     In this retrospective study the outcome of pelvic floor muscle training in 150 women will be~     tested regarding patients reported satisfaction and achievement of the incontinence~     improvement.~      Comparison of two age groups, controlled for BMI, parity and previous incontinence~     operations.~   "
161979|NCT01445821|"~     ASSIST I was the first randomized trial in patients with scleroderma to not just slow disease~     progression but rather actually reverse it. It is the first treatment to have ever~     demonstrated reversal of lung disease in scleroderma with improvement in FVC, total lung~     capacity (TLC), high-resolution computed tomography (HRCT), and QOL. We now, therefore,~     purpose to compare the ASSIST I conditioning regimen of cyclophosphamide and rATG to a less~     intense regimen of rATG/cyclophosphamide/Fludarabine. In the new regimen the cyclophosphamide~     dose is decreased to 120mg/kg (60mg/kg/day x 2) compared to 200mg/kg (50mg/kg/day) in the~     standard regimen. The lower dose of cyclophosphamide will be less cardiotoxic. This study~     will determine if the less cardiotoxic regimen will be safer than the standard regimen and as~     effective as the standard regimen.~   "
161980|NCT01445808|"~     The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and~     Training Program (PMT) for the improvement of physical fitness in patients with stable~     coronary heart disease as compared to advice in exercise training or treatment as usual.~   "
161981|NCT01445795|"~     This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of~     INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a~     study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV),~     Treatment-naïve subjects.~   "
161982|NCT01445782|"~     This study will investigate the safety and tolerability of AZD2115 following administration~     of multiple ascending doses.~   "
161983|NCT01445769|"~     The purpose of this study was to evaluate the effect of an alternative dosing strategy of~     ruxolitinib in subjects with primary myelofibrosis (PMF), post-polycythemia~     vera-myelofibrosis (PPV-MF) and post essential thrombocythemia-myelofibrosis (PET-MF) in~     order to minimize the development of anemia and thrombocytopenia.~   "
161984|NCT01445756|"~     Intrauterine contraception is a very effective, long term, reversible form of birth control,~     and is increasingly used in young, nulliparous patients. However, there is potential for pain~     with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous~     history of vaginal delivery. The potential pain associated with insertion is often a~     significant barrier for patients when choosing and IUD for contraception. Several methods of~     pain control have been studied, but none have been shown to reduce pain at time of insertion.~     Our research question is to determine if 2% topical lidocaine gel, instilled into the~     cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena~     Intrauterine System) in young, nulliparous patients. This will be studied in a randomized,~     double-blind placebo-controlled trial.~   "
161985|NCT01445743|"~     That is a double-blind randomized trial with parallel control to demonstrate the safety and~     immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is~     to determine the safety and immunogenicity of acellular Tdap vaccine.~      The experimental group will receive acellular Tdap vaccine and the control group will receive~     a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will~     be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the~     vaccine.~   "
161986|NCT01445730|"~     High fructose intake is increasingly recognized as causative in development of prediabetes,~     metabolic syndrome and cardiovascular disease (CVD). The mechanisms underlying~     fructose-induced metabolic disturbances are unclear but are beginning to be unraveled. In~     contrast to metabolism of glucose, the breakdown of fructose leads to the generation of~     metabolites that stimulate hepatic de novo lipogenesis (DNL) and increased levels of both~     fasting and postprandial triglycerides. The key lipogenic transcription factor seems to be~     activated by fructose independently of insulin. However, it is still controversial whether~     fructose consumption increases DNL in man to the extent that it induces metabolic~     disturbances. Animal studies have shown that also the adipose tissue is responsive to~     fructose feeding fructose, and that high fructose-feeding induces insulin resistance and~     inflammation in the adipose tissue. The role of intestinal insulin resistance in~     fructose-induced dysmetabolism has not been studied in detail. The critical question is~     whether the metabolic disturbances are induced by calorie excess or by fructose per se.~   "
161987|NCT01445717|"~     This study evaluates the use of a new method of growing and detecting Group B streptococcus~     in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the~     advantage of detecting GBS in less than 6 hours, with less cost, and the potential of~     allowing antibiotic sensitivities to be performed.~   "
161988|NCT01445704|"~     The purpose of this study is to evaluate the success of daily supplementation of multiple~     probiotic bacterial cultures over 12 weeks in increasing the percentage of excess weight loss~     in the RNYGB (Gastric Bypass) weight loss population.~   "
161989|NCT01445691|"~     The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid~     (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When~     the investigators remove the tumor from your brain, it is important that they remove all of~     the tumor and not remove parts of normal brain. Sometimes this can be difficult because the~     tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red~     under blue light. This may make it easier for your doctor to take out all of the tumor from~     your brain. The purpose of this study is to:~        -  Make sure that 5-ALA helps the doctor remove more of the tumor.~        -  Make sure 5-ALA does not cause any side effects.~      If you do not want to participate in this study, your doctor(s) will still do their best to~     remove all of the tumor in your brain. Whether or not you join this study will not change~     your treatment for your brain tumor.~   "
161990|NCT01445678|"~     This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of~     CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus~     meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections~     (cIAI).~   "
161991|NCT01445652|"~     The purpose of this study was to evaluate the relative benefits of daily disposable contact~     lenses versus spectacles in young adults.~   "
161992|NCT01445639|"~     Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent~     sedation and analgesia without respiratory depression. Dexmedetomidine has been used in~     critically ill medical, surgical, and pediatric patients. No study has been designed~     specifically to evaluate dexmedetomidine uses in the neurocritical care population. The~     primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic~     analgesia and sedation in patients after intracranial surgery.~   "
161993|NCT01445626|"~     This study will use retrospective data to evaluate the efficacy, safety, and re-injection~     interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).~   "
161994|NCT01445613|"~     The objective of the CANOPY trial is to assess the continued safety and effectiveness of the~     RX Acculink Carotid Stent System under commercial use in subjects at standard risk for~     adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of~     carotid stenting experience.~   "
161995|NCT01445600|"~     This is an open label, multi-centre, non-interventional post-marketing surveillance.~   "
162006|NCT01445405|"~     Background:~      Bortezomib acts on molecules in head and neck cancer cells that are important for the cells~     growth and survival. The drug may help make the cancer more sensitive to radiation and other~     chemotherapy drugs.~      Cetuximab is a monoclonal antibody that has increased the effectiveness of radiation~     treatment in patients with head and neck cancer in clinical trials.~      Cisplatin has shrunk head and neck cancers and improved treatment response and survival when~     combined with radiation treatment.~      Objectives:~      To determine the highest safe dose of bortezomib when combined with cetuximab without or with~     cisplatin and with radiation in patients with advanced head and neck cancer.~      To examine the benefits and side effects of these drug combinations with radiation in~     patients with advanced head and neck cancer.~      Eligibility:~      Patients 18 years of age and older with advanced Stage IV head and neck cancer who have not~     previously had neck radiation.~      Design:~      Patients will be assigned sequentially to one of two treatment groups: Group A receives~     bortezomib and cetuximab beginning the week before, and for the duration of, radiation~     therapy; Group B receives bortezomib, cetuximab and cisplatin beginning the week before, and~     for the duration of, radiation therapy.~        -  Cetuximab is given as a 2-hour infusion through a vein (intravenously, IV) for the first~          dose and then over 1 hour for subsequent weekly doses.~        -  Bortezomib is given as an injection into a vein over about 5 seconds, twice a week for 2~          weeks, followed by a 1-week rest for a total of three 3-week treatment cycles during~          radiation.~        -  Cisplatin is given in once a week as a 1-hour IV infusion~        -  Radiation therapy is given 5 days a week for 7 to 8 weeks.~      Post-treatment follow-up:~        -  Until 2 weeks after treatment ends, patients are followed once a week including a~          physical examination, review of treatment side effects, and blood tests.~        -  For 2 months after treatment ends, patients may need to return to the hospital for~          medical evaluation and supportive care, depending on their condition.~        -  8-weeks after treatment ends, patients return for evaluation with a history and physical~          examination; blood tests; ear, nose and throat evaluation and endoscopy; CT or MRI scan,~          or both, of the neck and chest; and, if indicated, a PET scan.~   "
161996|NCT01445587|"~     This is a single arm, open-label, Phase Ib/II study to evaluate the safety, pharmacokinetics,~     pharmacodynamics, and efficacy of the oral AKT inhibitor, GSK2110183, when administered to~     subjects with proteasome inhibitor refractory multiple myeloma (MM). During Part 1 of the~     study, GSK2110183 will be administered to subjects in sequential Pharmacokinetic (PK) Cohorts~     on a continuous daily dosing schedule in 21-day cycles until one of the Treatment~     Discontinuation Criteria is met. The PK Cohorts will characterize the PK of GSK2110183 in~     plasma and urine as well as determine the Recommended Phase 2 Dose (RP2D) of GSK2110183. The~     RP2D will be that dose that provides adequate PK exposure and biologic activity without~     exceeding the maximum tolerated dose (MTD) in MM subjects as defined in the current study. In~     Part 2 of the study, the RP2D will be further evaluated using a flexible 2-stage design with~     a stopping rule to allow for early termination based on lack of efficacy at the end of Stage~     1. The first stage will accrue 20 subjects who will receive GSK2110183 at the RP2D. If a~     clinical response is observed in at least 1 subject in Stage 1, the study will proceed to~     Stage 2 and 20 additional subjects will be enrolled. GSK2110183 will be administered in Part~     2 (Stage 1 and Stage 2) on a continuous daily dosing schedule in 21 day cycles until~     International Myeloma Working Group criteria for progression are met, at which point the~     subject will proceed to GSK 2110183 + bortezomib salvage therapy provided they meet the~     additional eligibility criteria for this phase of the study. GSK2110183 and bortezomib will~     be continued until one of the Treatment Discontinuation Criteria is met.~      Exploratory PK/PD analyses may be performed to examine the potential relationships between~     GSK2110183 pharmacokinetics and pharmacodynamic biomarkers.~   "
161997|NCT01445561|"~     Background:~      - Interleukin-2 is a drug that can help stimulate the body s response to inflammation. High~     dose interleukin-2 has been used to treat different types of cancer and immune system~     disorders. However, it can cause frequent and often serious side effects at the doses~     currently used for treatment. Very low dose interleukin-2 (700 folds less than regular dose)~     was previously tested in cancer patients and stem cell transplant recipients. The study~     observed important immune changes and minimal side effects in those patients. Researchers~     want to test the healthy immune system's responses to very low doses of interleukin-2 to~     better understand how the drug works.~      Objectives:~      - To study the effects of very low doses of interleukin-2 on healthy volunteers.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine samples.~        -  Participants will receive one of two possible very low doses of interleukin-2 every day~          for 5 days.~        -  Blood samples will be taken twice before the first dose, 1 day after the first dose, and~          before the next three doses. Followup blood samples will be taken on Days 7, 14, and 28~          after the first dose.~   "
161998|NCT01445548|"~     This study will determine whether a drug called sirolimus is safe to give to people with~     geographic atrophy (GA) and if it can help preserve vision in patients. GA is an advanced~     form of dry age-related macular degeneration (AMD). AMD affects the macula, the central part~     of the retina at the back of the eye needed for sharp, clear vision. There are two types of~     AMD, wet and dry. In dry AMD, cells in the macula die.~      GA may be partially caused by inflammation. Sirolimus helps prevent inflammation and~     therefore may help people with GA. Researchers want to see whether sirolimus can help prevent~     vision loss in people with GA.~      People at least 56 years of age who have GA related to AMD in both eyes may be eligible for~     this study.~      This study requires at least 8 visits to the National Eye Institute over 1 year. Study visits~     will be every 2 months for 1 year.~      Participants will undergo the following procedures:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, and eye exams. One eye will be selected as the study eye to~          receive the sirolimus injections.~        -  Participants will have a sirolimus injection into the study eye at the first visit and~          every 2 months thereafter unless contraindicated. There will be a follow-up eye exam 1~          month after the first injection.~   "
161999|NCT01445535|"~     Studies conducted at the National Cancer Institute suggest that certain chemotherapy drugs~     may be more effective if given by continuous infusion into the vein rather than by the~     standard method of rapid intravenous injection. One such combination of six chemotherapy~     drugs, known as EPOCH-R, has had a high degree of effectiveness in people with certain kinds~     of cancer. Recent evidence also indicates that the effects of chemotherapy may be improved by~     combining the treatment with monoclonal antibodies, which are purified proteins that are~     specially made to attach to foreign substances such as cancer cells. This protocol is~     specifically for adults with the types of cancer known as T-cell and NK-cell lymphomas, who~     have never received chemotherapy previously. The additional monoclonal antibody in the study,~     called siplizumab, has been manufactured to attach to the CD2 protein contained in these~     types of tumors.~      Study volunteers will need to undergo an initial period of evaluation that may take up to 3~     weeks and may be done on an outpatient basis. Evaluation may include some or all of the~     following tests: blood and urine tests, tests of lung and heart function, lumbar punctures to~     take samples of cerebrospinal fluid, magnetic resonance imaging (MRI) or computerized~     tomography (CT) scans, full-body positron emission tomography (PET) scans, bone marrow~     biopsies, and biopsies of suspected tumor areas.~      During the study, patients will receive EPOCH-R chemotherapy, which includes the following~     drugs: etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. The~     additional drug, siplizumab, will be given by IV infusion on the first day of treatment over~     several hours. When the siplizumab IV infusion is complete, the drugs doxorubicin, etoposide,~     and vincristine will each be given by continuous IV infusion over the next 4 days (that is,~     continuously for a total of 96 hours). When this infusion is completed, the drugs rituximab~     and cyclophosphamide will be given by IV infusion over several hours on Day 5. Prednisone~     will be given by mouth twice each day for 5 days. Patients may be given other drugs to treat~     the side effects of chemotherapy and to prevent possible infections.~      The siplizumab-EPOCH-R therapy will be repeated every 21 days, which is known as a cycle of~     therapy, for a total of 6 cycles. Following the fourth and sixth treatment cycles~     (approximately weeks 12 and 18) of siplizumab-EPOCH-R, study researchers will perform blood~     tests and CT/MRI scans on all patients to assess their response to the treatment.~   "
162012|NCT01445314|"~     Background:~        -  People with chronic illness often are at risk for developing neurobehavioral problems~          due to effects of the disease or associated treatments. These problems may include~          cognitive impairments involving problem-solving, remembering things, paying attention,~          and understanding and using language, or emotional functioning or quality of life.~        -  The National Cancer Institute Medical Illness Counseling Center Neuropsychology Group~          has collected data from neurobehavioral evaluations of infants, children, adolescents~          and adults with chronic illnesses enrolled in NIH protocols since 1987 and continues to~          collect data from patients enrolled in current protocols.~        -  The data from these evaluations, along with demographic and medical information are~          stored in an NIH computer database.~        -  Investigating the neurobehavioral functioning of patients with chronic illness is~          important for identifying and monitoring the effects of the disease and treatments over~          time, determining possible at-risk subgroups, evaluating response to therapy, and~          recommending educational and rehabilitative interventions.~      Objectives:~      -To learn about how certain illnesses or treatments may affect a person s cognitive~     abilities, emotional functioning and quality of life.~      Eligibility:~        -  Patients currently enrolled in NIH studies who are having neuropsychological testing or~          completing quality-of-life questionnaires as part of that study.~        -  Data obtained from infants, children, adolescents, and adults administered~          neurobehavioral assessments as part of a past or future NIH protocol.~      Design:~        -  This study does not involve any extra tests or questionnaires; it uses information~          collected from evaluations that subjects have already completed or will complete as part~          of other NIH studies.~        -  Information about participating patients that may help elucidate how cognitive~          abilities, emotional functioning, and quality of life are affected in people with~          chronic illness may be collected and stored.~   "
162000|NCT01445522|"~     Background:~        -  Cyclophosphamide (CP) is a drug approved by the Food and Drug Administration for the~          treatment of certain cancers. It works by causing DNA damage, resulting in cell death,~          including cancer cells.~        -  ABT-888 is an experimental drug that has been given to a small number of patients. It~          works by preventing DNA repair in tumor cells.~      Objectives:~        -  To test the safety of the combination of ABT-888 and CP, and to determine the dose of~          each drug that can be given together to patients with cancer.~        -  To see how the body handles ABT-888 when given together with CP~        -  To evaluate the anti-tumor response of the drug combination.~      Eligibility:~        -  Adults with solid tumors or lymphoid cancers (lymphoma and chronic lymphocytic leukemia)~          whose disease does not respond to standard treatments.~      Design:~        -  Patients take ABT-888 by mouth once a day for 7, 14 or 21 days, depending on the dose~          level assigned to the individual patient.~        -  Patients take CP by mouth once a day every day in 21-day cycles. (Some patients take CP~          for 14 days only.)~        -  Patients undergo tests and procedures periodically during the study, including:~        -  Clinic visit and physical examination at the beginning of each cycle~        -  Blood and urine tests, electrocardiogram, measurement of vital signs~        -  CT scans, MRI scans or ultrasound tests to check the response of the tumor to treatment~        -  Tumor biopsies (optional)~        -  Bone marrow aspiration and biopsy~   "
162001|NCT01445509|"~     Background:~        -  Bevacizumab inhibits blood vessel growth in cancer cells by blocking a growth factor~          called VEGF. Dasatinib inhibits the action of proteins called tyrosine kinases, which~          promote and stimulate blood vessel formation and cancer growth and spread.~        -  Using the two drugs in combination may provide a more effective cancer treatment than~          either drug used alone.~        -  Both drugs have been approved by the Food and Drug Administration for different cancer~          types, but their use in combination sis experimental.~      Objectives:~      - To determine the highest doses of the combination of dasatinib and bevacizumab that can be~     safely given to patients with different cancers and to find out what effects, good and bad,~     these drugs may have on the patient and the disease.~      Eligibility:~      - Adult patients with an advanced solid tumor cancer that cannot be treated successfully with~     standard therapies.~      Design:~        -  Patients in Group 1 receive dasatinib and bevacizumab together throughout the study. The~          dose is increased in successive groups of three to six patients until the optimum safe~          dose is determined. Patients take dasatinib by mouth once a day and receive bevacizumab~          as an infusion through a vein once every 2 weeks in 28-day treatment cycles.~        -  Patients in Group 2 are randomly assigned to receive either dasatinib or bevacizumab for~          cycle one, and then both drugs for all subsequent cycles. The drug doses are based on~          the optimum doses found in Group 1 patients.~        -  Patients have a physical examination and blood and urine tests every 2 weeks for cycles~          1 and 2, and then every 4 weeks for the duration of treatment.~        -  Patients have CT or MRI scans or another imaging test such as ultrasound every 8 weeks~          to monitor the cancer s response to treatment.~        -  Tumor biopsies are obtained from patients in Group 2 before treatment, 2 weeks into the~          first treatment cycle, and 2 weeks into the second cycle.~        -  Dynamic, contrast-enhanced MRI (DCE-MRI) tests are done on patients in Group 2 before~          treatment, 2 weeks into the first cycle and 4 weeks into the second cycle. This MRI test~          uses a special non-radioactive dye that shows blood flow in a certain part of the body.~        -  For patients who have been on the study over 2 years, the cycle may be lengthened to 6~          or 8 weeks at the discretion of the investigator.~   "
162002|NCT01445483|"~     Background:~        -  There are no standardized sets of tests to measure changes in neuropsychological~          functioning in patients treated for brain metastasis (cancer that has spread beyond the~          original site to the brain).~        -  Neuropsychological function has an important effect on quality of life and should be~          included when determining treatment options.~      Objectives:~        -  To find out if there is a change in patients cognitive (thinking) and daily functioning~          after standard radiation treatment for brain metastasis that can be measured with tests.~        -  To see if any changes on these tests are related to patients response to radiation~          therapy.~      Eligibility:~      - Patients 18 years of age or older who have cancer that has spread to the brain.~      Design:~        -  Patients receive a 2-week course of radiation therapy to the brain, given daily 5 days a~          week. Some patients may require stereotactic radiosurgery (an additional boost of~          radiation therapy to specific sites of brain metastasis).~        -  Patients have the following evaluations before and after treatment to determine changes~          in cognition and functioning:~        -  Neuropsychological testing to measure cognitive (thinking) abilities like memory,~          attention, processing speed, and reading, and fine motor skills.~        -  Questionnaires to assess quality of life and daily living skills.~        -  Patients have MRI scans and blood and urine tests.~        -  At the completion of radiation treatment, patients return to the clinic for follow-up~          visits at 1, 2, 4, 6, 9 and 12 months for blood and urine tests, physical examination,~          MRI of the brain, neuropsychological testing and assessments of quality of life and~          daily living skills.~   "
162003|NCT01445444|"~     The purpose of the current study is:~        1. To evaluate the effectiveness of a habit reversal training (HRT) approach for children~          ages 7 to 17 years of age inclusive with a diagnosis of trichotillomania.~        2. To explore factors that may relate to symptom severity, treatment outcome, and~          psychosocial impairment (e.g., specific symptom presence, co-morbidity, emotional~          regulation).~   "
162004|NCT01445431|"~     Among adult patients with chronic kidney disease undergoing hemodialysis, what is the~     efficacy and safety of virgin coconut oil compared to mineral oil as a therapeutic~     moisturizer for uremic xerosis?~   "
162005|NCT01445418|"~     Background:~        -  Carboplatin is approved by the Food and Drug Administration to treat cancer.~        -  AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a~          protein that is -involved in repairing DNA damage; PARP inhibitors interfere with that~          process.~      Objectives:~        -  To determine the optimum doses of AZD2281 and carboplatin that can safely be used in~          patients with breast and ovarian cancer.~        -  To evaluate the response of the tumor to the drug combination and determine the side~          effects of the treatment.~      Eligibility:~      -Patients 18 years of age or older with breast or ovarian cancer who have a family history of~     cancer or who have a BRCA1 or BRCA2 mutation.~      Design:~        -  In this dose escalation study, the first small group of patients receives the smallest~          study doses of AZD2281 and carboplatin. Subsequent groups receive incrementally higher~          doses of first AZD2281 and then carboplatin as long as the preceding group has not~          experienced unacceptable side effects. When the highest safe dose is determined,~          additional patients receive that dose.~        -  Patients receive treatment in 21-day cycles as follows: AZD2281 by mouth twice a day~          every day; carboplatin thorough a vein on day 8 of each cycle. Treatment may continue~          until it is no longer beneficial.~        -  Evaluations during treatment include the following:~        -  Physical examination 1 week after starting treatment and then every 3 weeks.~        -  Blood tests weekly for the first 4 weeks of treatment and then every 3 weeks.~        -  CT scans or other imaging tests such as ultrasound or MRI every 6 weeks to evaluate the~          tumor.~   "
186567|NCT01122550|"~     The purpose of this study is to evaluate its reproducibility of overactive bladder symptom~     score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.~   "
162007|NCT01445392|"~     Background:~      Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin.~     However, the benefits of this treatment are limited, and in most treated patients the disease~     continues to worsen.~      SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a~     certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a~     bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the~     cancer cells, allowing the toxin to enter and kill the cells.~      Objectives:~      To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in~     patients with mesothelioma.~      To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not~     cause unacceptable side effects).~      To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients~     tumors.~      To learn how the body breaks down SS1(dsFV)PE38.~      Eligibility:~      Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot~     be cured with surgery, and have not had prior treatment with chemotherapy.~      Design:~      Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows:~        -  Day 1 - Intravenous (through a vein) infusions of pemetrexed and cisplatin.~        -  Days 1 and 2 - Intravenous solution to prevent dehydration that might occur with~          SS1(dsFV)PE38.~        -  Days 1, 3 and 5 Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients~          are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no~          significant side effects, the next group a higher dose. This continues in succeeding~          groups until the maximum tolerated study dose (highest dose that patients can be given~          safely) is determined.~      Continuing standard treatment with additional cycles of pemetrexed and cisplatin.~      Evaluations during the treatment period:~        -  Physical examination, including vital signs and body weight checks, and pregnancy test~          for women who can become pregnant.~        -  Questions about medications and side effects.~        -  Blood and urine tests.~        -  Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests,~          pulse oximetry, performance of daily activities and quality-of-life questionnaires.~      Post-treatment evaluations:~        -  Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease~          assessment.~        -  End-of-study visit for blood tests, vital signs and weight measurements, disease~          assessment, electrocardiogram, pregnancy test for women who can become pregnant~   "
162008|NCT01445379|"~     This study will examine the safety and efficacy of ipilimumab-an experimental cancer~     treatment drug used to boost immune response-in children, adolescents, and young adults.~     Ipilimumab may allow immune cells to react to and destroy abnormal cells in the body, and has~     been tested in adults for a variety of cancers and has shown responses in some research~     studies. Because ipilimumab has not been tested in children, adolescents, or young adults, it~     is considered an experimental drug. The purposes of this research study are to determine the~     highest safe dose of ipilimumab for children, adolescents, and young adults with solid tumor~     cancers; examine its effectiveness and possible side effects; and better understand how the~     body and the immune system process it over time.~      Candidates must be between 2 and 21 years of age and must have solid malignant tumors that~     have been resistant to standard therapy. Volunteers will be screened with a medical history,~     a clinical examination, and computerized scans such as magnetic resonance imaging (MRI).~     Participants must have completed their last dose of chemotherapy, radiation, chemotherapy, or~     antibody or investigational therapy at least four weeks prior to enrollment.~      During the study, participants will receive an intravenous dose of ipilimumab once every~     three weeks. The infusion of ipilimumab will last 90 minutes, and the participant s vital~     signs will be monitored while the medicine is infusing and several times in the first 24~     hours after the first dose (requiring a hospital stay during that time). If the participant~     is able to tolerate the first dose of ipilimumab, further doses (called cycles ) may be~     received on an outpatient basis. Blood and urine tests will be given on a regular basis~     during these cycles. After four cycles, participants whose tumors do not grow and who do not~     have unacceptable side effects will continue to receive ipilimumab every three months to~     maintain the current condition, until researchers conclude the study.~   "
162009|NCT01445366|"~     This is a prospective cross-over study including 10 stable hemodialysis patients with chronic~     kidney disease stage 5. The cross-over study lasts 2 weeks with the study dialysis sessions~     at midweek.~      During one session, the patient will be dialyzed during 4 hours with high volume post~     dilution hemodiafiltration (HDF) with an FX800 hemodialyzer (Fresenius Medical Care) and a~     blood flow of 300mL/min, dialysate flow of 500mL/min, and substitution flow of 75mL/min.~      During the other midweek session, the patient will be dialyzed during 8 hours with high flux~     hemodialysis (HD) with an FX80 hemodialyzer (Fresenius Medical Care) and a blood flow of~     200mL/min and a dialysate flow of 500mL/min.~      The HDF and HD sessions will be randomized. Blood samples will be drawn pre and post dialysis~     from the arterial blood line, and after 30min after dialysis start, a blood sample will be~     drawn from the inlet and outlet line.~      At the dialysate outlet line, partial dialysate collection is performed at the outlet line.~      Blood and dialysate samples will be analyzed for a broad range of retention solutes like~     small and water soluble solutes, middle molecules, and protein bound solutes.~      These data will be further used to calculate solute removal and evaluate any differences~     between the solute removal during high volume post dilution HDF and high flux HD.~   "
162010|NCT01445340|"~     Background:~        -  Cutaneous T-cell lymphoma (CTCL) is a rare, slow-growing form of skin cancer. The cancer~          cells are found in red, scaly patches that may sometimes itch.~        -  Early-stage CTCL is usually treated with topical therapies, which may lose effectiveness~          over time and have adverse effects, such as risk of secondary skin cancers and~          difficulty of use.~        -  Romidepsin is an experimental drug that, given through a vein, has improved CTCL in some~          patients with later stages of the disease.~        -  A topical ointment form of romidepsin may be helpful in treating early-stage CTCL.~      Objectives:~        -  To determine the highest tolerated dose of topical romidepsin that can be given to~          patients with early-stage CTCL.~        -  To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL.~        -  To determine how the body handles topical romidepsin.~      Eligibility:~      -Patients 18 of age and older with early-stage CTCL.~      Design:~        -  Study Part 1: Successive groups of 3 patients are treated with increasingly higher~          concentrations of topical romidepsin until the highest tolerated dose is found.~        -  Study Part II: The highest tolerated dose, as determined in Part I, is applied to larger~          areas of skin in another group of patients.~        -  All study participants apply the study medicine to their skin three times a day for 4~          weeks.~        -  During treatment, participants are monitored at weeks 2 and 4 with a history and~          physical examination, blood tests, electrocardiogram, skin biopsies and photographs of~          the skin.~        -  After stopping treatment, participants return to the clinic at weeks 6 and 8 for blood~          tests and to see how the study medication is affecting the body.~   "
162011|NCT01445327|"~     Background:~        -  Gastrointestinal cancers are among the most commonly diagnosed cancers in the United~          States.~        -  There are currently no tests to predict how patients with gastrointestinal cancers will~          respond to radiation therapy or which patients may develop side effects from treatment.~        -  Studies on tumor cells in the stool, urine, or blood from patients may provide valuable~          information that can be used to develop tests to determine which patients may need more~          or less aggressive therapy.~        -  Studies of other substances in the stool, urine, or blood from patients may provide~          valuable information that can be used to develop tests to determine which patients are~          likely to develop side effects from radiation treatments.~      Objectives:~        -  To collect blood, urine and stool specimens from patients with gastrointestinal cancers~          who will undergo radiation therapy.~        -  To study hormone and protein changes in these blood, urine and stool specimens before,~          during and after radiation treatment in order to develop a way to predict how~          gastrointestinal cancers will respond to radiation therapy and if patients with these~          cancers will develop side effects from radiation treatment.~      Eligibility:~      -Patients 18 years of age and older with cancer of the gastrointestinal tract (esophagus,~     stomach, pancreas, rectum) who plan to receive radiotherapy to the site of the cancer on an~     NCI protocol~      Design:~      Participants undergo the following procedures:~        -  Tumor biopsy: Before any treatment or at the time of surgery if it is the first~          treatment~        -  Urine collection: Before, during, and after treatment and at follow-up visits.~        -  Stool collection: Before, during, and after treatment and at follow-up visits.~        -  Blood collection: Before, during, and after treatment and at follow-up visits.~        -  Intestinal permeability assessment: Before any treatment, before radiation (if radiation~          is not the first treatment), 1 month after radiation is completed, and 3 months after~          radiation is completed. This test determines how the patient s intestines are working to~          absorb sugar and may provide information about side effects from radiation treatments.~          Patients fast after midnight, then drink a small glass of sugars, and then do a 6-hour~          urine collection.~   "
162014|NCT01445288|"~     This study will analyze the effects of radiation given to children who have tumors of the~     central nervous system (CNS). Researchers want to learn more about changes in the quality of~     life that patients may experience as a result of radiation.~      Patients ages 21 and younger who have a primary CNS tumor and who have not received radiation~     previously may be eligible for this study. They will have a medical history and physical~     examination. Collection of blood (about 2-1/2 tablespoons) and urine will be done, as well as~     a pregnancy test. Patients will complete neuropsychological tests, which provide information~     about their changes in functioning over time. An expert in psychology will give a number of~     tests, and the patient's parents or guardian will be asked to complete a questionnaire about~     the patient's behavior. Also, patients will be given a quality of life questionnaire to~     complete and vision and hearing tests. The radiation itself is prescribed by patients'~     doctors and is not part of this study.~      Magnetic resonance imaging (MRI) will give researchers information about the tumor and brain,~     through several scanning sequences . MRI uses a strong magnetic field and radio waves to~     obtain images of body organs and tissues. Patients will lie on a table that slides into the~     enclosed tunnel of the scanner. They will need to lie still, and medication may be given to~     help them to do that. They may be in the scanner for up to 2 hours. As the scanner takes~     pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to~     reduce the noise. A contrast agent will be administered, to allow images be seen more~     clearly. Blood and urine tests will be conducted after the first dose of radiation. MRI scans~     will be done 2 weeks after patients finish radiation therapy and again at 6 to 8 weeks, 6~     months, 12 months, and yearly. Also at those follow-up periods, patients will undergo similar~     procedures as previously, including blood and urine tests and neuropsychological testing.~     Patients can remain in this study for 5 years.~   "
162015|NCT01445275|"~     This research trial collects information about types of treatment and the cost of these~     procedures in women with elevated genetic risk for ovarian cancer who participated on the~     Gynecology Oncology Group (GOG)-0199 trial. Gathering information about women at elevated~     genetic risk for ovarian cancer may help doctors learn more about risk reduction procedures~     and the cost of these procedures.~   "
162016|NCT01445262|"~     This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy data~     among subjects with allergic rhinitis, urticaria, eczema, dermatitis, skin irritation,~     prurigo or pruritus cutaneous who have never been treated with levocetirizine tablets before.~   "
162017|NCT01445249|"~     Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and~     is very painful. Local anaesthetic nerve blocks are used to provide pain relief after this~     work. The purpose of this study is to compare two techniques: one using anatomical landmarks~     alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation~     to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques~     will be compared for reliability of postoperative analgesia.~   "
162018|NCT01445236|"~     Immunosuppressive drugs can be successfully withdrawn in a fraction of liver transplant~     patients. Specific peripheral blood gene expression markers can be employed to select~     patients with a high likelihood of being tolerant. In the current study the investigators~     propose to conduct a pilot non-randomized prospective study in which gradual weaning of~     immunosuppressive drugs will be offered to liver recipients exhibiting a favorable peripheral~     blood gene expression profile.~   "
162019|NCT01445223|"~     The present study aims to compare efficacy, side-effects, and treatment adherence of three~     different treatment regimens given to antiretroviral naïve HIV-1 infected patients. Treatment~     will be initiated in accordance with the Swedish National Guidelines. In the twice daily~     (BID) arm (1), which could be considered as a standard regimen at present,~     lopinavir/ritonavir, is co-administrated with 2 nucleoside reverse transcriptase inhibitors~     (NRTIs) administrated BID. The first once daily (QD) arm (2) combines the protease inhibitor~     (PI) atazanavir/ritonavir with 2 NRTIs administrated QD, and in the second QD arm (3), the~     non nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz is combined with 2 NRTIs~     administrated QD. All drugs used in the study are licensed in the participating countries and~     patients will be followed as in clinical practice. Patients could optionally, after informed~     consent, be followed with additional measurements of HIV-1 RNA after 1, 2, and 3 weeks of~     treatment to asses the kinetics of viral decline after initiation of treatment.~   "
162020|NCT01445210|"~     The most useful method to manage pain after major ankle surgery is infusion of local~     analgesics with a catheter close to the sciatic nerve.~      Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified~     in the sciatic nerve) and the saphenous nerve.~      Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve~     catheter provide a better treatment of pain in comparison with a single injection nerve~     block. In addition cost-effectiveness of the two methods are compared.~      The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary~     analysis of the data from the first 40 patients. However, it is not an interim analysis.~     Fifty patients will be included independent of the result of the preliminary analysis. The~     random allocation of the last 10 patients will also be double-blinded.~   "
162021|NCT01445197|"~     This is a clinical study to investigate how well Biostate works in treatment of male patients~     below the age of 12 years who have a clotting factor deficiency that is aggravated by the~     development of antibodies. The antibodies are directed against the clotting factor that is~     given for replacement therapy and usually make therapy unsuccessful. The treatment used in~     this study is called immune tolerance therapy.~   "
162022|NCT01445171|"~     The purpose of this clinical investigation is to confirm that the safety and performance of~     the EDWARDS INTUITY Valve System.~   "
162023|NCT01445158|"~     Background:~        -  Hematopoietic Stem Cell Transplant (HSCT) represents the second most frequent major~          organ transplant in the United States.~        -  Pediatric 1st degree stem cell donors can experience a variety of psychological~          difficulties before and after donation with those who feel they are not adequately~          prepared for possible complications following stem cell donation and transplant~          describing negative emotions.~        -  The importance of preparation for children undergoing medical procedures has long been~          recognized in the field of pediatric psychology~      Objectives:~        -  To assess how prepared pediatric donors are for stem cell donation by assessing their~          knowledge about stem cell transplants, and to assess their anxiety at different stages~          of the donation process.~        -  To assess the effectiveness of a workbook and a board game as tools for conveying~          information on donation and transplantation to donors.~        -  To identify donors who may require additional preparation before stem cell collection.~        -  To explore the relationship between donor knowledge and anxiety symptoms.~      Eligibility:~      -Stem cell donors ages 10 to 26 years of age~      Design:~        -  Participant s baseline knowledge and anxiety are evaluated.~        -  Participant s knowledge is reassessed and anxiety evaluated following an information~          session with the research nurse and doctor about the procedures for stem cell donation~          and discussion of the consent form for the transplant protocol.~        -  Participants are separated into two groups. Donors 10 to 15 years of age play a board~          game; those 16 to 26 years of age are given a workbook on stem cell transplant.~        -  Participants knowledge and anxiety are reassessed within 24 hours after working with the~          educational materials and again 1 month later.~   "
162058|NCT01444651|"~     The purpose of this study is to find out if tadalafil can help overweight and obese people~     metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day~     of tadalafil for 3 months is safe to take without causing too many side effects. The~     investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).~   "
162024|NCT01445145|"~     Background:~        -  Few resources exist for helping adolescents and young adults with cancer or HIV disease~          understand their changing physical, emotional and social needs when treatment is no~          longer effective.~        -  An advance directive document called Five Wishes has had particular success with the~          adult population because of the consideration of personal, emotional and spiritual needs~          in addition to medical and legal concerns.~      Objectives:~      -To learn which questions in Five Wishes are useful for adolescents and young adults and to~     then create a new document that reflects the issues they feel are most appropriate for people~     with cancer or HIV disease.~      Eligibility:~      -Adolescents and young adults 16 to 30 years of age with advanced cancer or HIV disease~     acquired perinatally or early in life and enrolled in an active NIH treatment protocol.~      Design:~        -  Stage 1: Participants go through each question in Five Wishes and respond to whether~          they feel the questions are useful.~        -  Stage 2: Participants are asked to compare each question from Five Wishes to a newly~          developed document based on the feedback received during first stage of the study.~        -  Participants are enrolled for either Stage 1 or Stage 2 depending on the date they enter~          the study.~   "
162025|NCT01445132|"~     Background:~        -  After allogeneic (donor) stem cell transplantation, a new immune system grows in the~          patient from the transplanted donor stem cells and lymphocytes (type of immune cell).~          Donor lymphocytes, unlike the patient s own lymphocytes, often can recognize the patient~          s tumor cells as being foreign and destroy them.~        -  It is thought that tumor shrinkage after stem cell transplantation is the result of~          donor T lymphocytes, or T cells. Some studies show that patients with tumors that have T~          cells are better able to keep tumor growth in check.~        -  Patients who have had donor stem cell transplantation may have donor T cells in their~          tumors that can recognize and fight their cancer. Compared with donor T cells taken~          directly from the donor and infused into the patient, donor T cells found in patients~          tumors may be specific for the cancer cells and thus better able to attack tumor. Also,~          because the T cells found their way to the tumor, they may be less likely to recognize~          and attack non-tumor tissues than the T cells given in donor lymphocyte infusions.~        -  The T cells may be especially effective at controlling tumor if they are given an~          additional stimulus to become active. Costimulation is the name of the body s natural~          process for providing an extra stimulus, and can be performed on cells in the~          laboratory. Costimulation can produce large numbers of activated cells that may be able~          to attack cancer cells and shrink tumors.~      Objectives:~      -To evaluate the ability of lymphocytes found in tumors from patients who have received donor~     stem cell transplants to control their tumor growth.~      Eligibility:~      -Patients between 18 and 75 years of age with a B-cell cancer that has continued to grow or~     recurred after remission following allogeneic stem cell transplantation. This includes~     patients who have received transplants from unrelated donors and cord blood.~      Design:~        -  Immune cells are collected from patients blood and blood from their stem cell donor.~        -  Patients undergo surgery to remove their tumor and a small piece of skin. In the~          laboratory, donor T cells are isolated from the tumor and costimulated to expand the~          number of cells and activate them.~        -  The expanded, activated T cells as infused into the patient.~        -  Patients have a needle biopsy and possibly surgery to remove a sample of remaining tumor~          for research studies.~        -  Patients are followed at the NIH clinic 48 hours after the cell infusion, and again at~          1, 2, 4, 8 and 12 weeks after the infusion. Tumor size is monitored every month with CT~          scans, and possibly also with a PET or bone marrow aspiration and biopsy, for the first~          3 months after the cells are infused. Thereafter, visits are less frequent (every 3~          months, then every 6 months, and then yearly) during a minimum 5-year follow-up.~   "
162026|NCT01445119|"~     This study will evaluate the safety and effectiveness of Enzastaurin, an experimental drug~     that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients~     who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of~     cancers, though not recurrent gliomas. Tumor growth involves new cancer cell formation and~     accumulation, requiring a blood supply. Research shows that brain tumor cells can produce~     substances that stimulate new blood vessel formation. This study will look into whether the~     combination of drugs can stop that process.~      Patients ages 18 and older who have recurring gliomas, who are not pregnant or breast~     feeding, and who do not have serious diseases may be eligible for this study. About 96~     patients will participate for 1 year. They will have a physical examination, give blood and~     urine samples for analysis, and undergo magnetic resonance imaging (MRI) or computed~     tomography (CT) scans regarding tumor growth, and perhaps an electrocardiogram. Patients may~     also undergo a dynamic MRI with spectroscopy or PET scan (positron emission tomography), to~     distinguish a live tumor from a dying one. Researchers are studying patients taking a certain~     type of antiseizure medicine and patients who are not taking it because some antiseizure~     medicines may change the way the body handles a drug such as Enzastaurin. There will be two~     groups of participants, with 16 to 48 each. Group A is not taking enzyme-inducing antiseizure~     drugs, and Group B is taking such drugs. In Groups A and B are four dose levels, with 4 to12~     patients at each level. Patients' doctors will tell them which group they belong to and how~     much Enzastaurin and Carboplatin they will take. Treatment consists of Enzastaurin every day~     for 5 weeks in Cycle 1 only and for 4 weeks beginning with Cycle 2 (each 4-week period as a~     cycle). Patients take Enzastaurin within 30 minutes after a meal. History, physical, and~     neurological examinations are repeated at the end of Cycle 1 and then every 4 weeks. Patients~     will have a repeat head MRI or CT scan before each cycle. If they tolerate the drugs without~     serious side effects and the tumor is not growing, they may continue with another cycle of~     Enzastaurin, taking the tablets every day, and Carboplatin being infused on Day 8 of Cycle 1~     and on Day 1 of each additional cycle. Routine lab tests are done regularly. Patients will~     continue the 4-week cycles of treatment for as long as they have no serious side effects and~     there are no signs of tumor growth. Side effects of Enzastaurin may be fatigue, constipation,~     cough, and nausea. In men, there may be a decrease in sperm count. Carboplatin can lead to~     low counts in blood cells and platelets, and there may also be an allergic reaction. Vomiting~     is a likely side effect. At injection sites, there may be redness, swelling, and pain.~      This study may or may not have a direct benefit for participants. However, information gained~     may help the sponsor of the study, Eli Lilly and Company, and may help patients in the future~     who have gliomas.~   "
162027|NCT01445106|"~     Background:~        -  The PI3K/Akt/mTOR pathway is an important target in cancer because it promotes~          chemotherapeutic resistance and confers a poor prognosis for many types of cancers.~        -  Several inhibitors of the pathway are being developed as cancer therapeutics. However,~          the process of de novo drug development takes years, and is often curtailed due to~          diminished activity and/or unforeseen toxicities in clinical trials.~        -  One approach to expedite the development of new cancer therapies is to test drugs that~          are already approved for other indications.~        -  Our group has shown that nelfinavir, an orally available FDA-approved HIV-1 protease~          inhibitor used to treat HIV/AIDS, can inhibit endogenous Akt and growth factor receptor~          induced Akt activity in cancer cells.~        -  Importantly, nelfinavir demonstrates dose-dependent cytotoxicity in every cell line in~          the NCI 60 cell line panel at plasma concentrations attainable in human plasma, is~          profoundly effective in cancer cell lines that have been selected to become resistant to~          standard therapies, and inhibits tumor growth in-vivo.~      Objectives:~        -  Because an MTD with nelfinavir has not been observed in prior phase I studies with HIV~          patients, the objectives of the Phase I design will be:~        -  To establish the MTD and dose limiting toxicity for this drug in patients with solid~          Tumors.~        -  To correlate nelfinavir pharmacokinetics with baseline activity of CYP3A4 as assessed by~          measuring midazolam clearance.~        -  To preliminarily explore the biological and clinical effects through a series of~          correlative studies involving analysis of blood and tissue across patients throughout~          the study.~      Eligibility:~      -Adults with solid tumors who are refractory to, or have relapsed after receiving, standard~     front-line chemotherapies are eligible.~      Design:~        -  Patients will receive nelfinavir beginning at the FDA-approved dose for HIV patients~          (1250 mg po bid).~        -  Dose escalations will occur for 6 dose levels i.e. cohorts, or until the MTD is reached.~        -  Up to 45 patients are expected to be enrolled.~        -  Staging CT scans will be performed every two cycles.~   "
162028|NCT01445080|"~     Background:~        -  Sorafenib is an experimental anti-cancer drug that works by blocking proteins thought to~          be important for tumor growth. It has blocked the growth of tumors in test tubes and in~          some animal models.~        -  Sorafenib is approved for the treatment of advanced kidney cancer.~        -  This is the first time sorafenib is being tested in children with cancer.~      Objectives:~        -  To determine the highest dose of sorafenib that can be safely given to children and~          young adults with cancer.~        -  To determine the side effects and benefits, if any, of sorafenib in children and young~          adults with cancer.~        -  To study how the body handles sorafenib and the drug's effects on cells and proteins in~          the blood.~      Eligibility:~      -Patients between 2 and 21 years of age with solid tumors or leukemias that do not respond to~     standard treatment.~      Patients between 2 and 21 years of age with AML and FLT3-ITD mutation for Part C of the~     study.~      Design:~        -  Patients take sorafenib tablets every day about every 12 hours in 28-day treatment~          cycles for a maximum of 24 cycles.~        -  The dose is increased in succeeding groups of 3 to 6 children until serious side effects~          occur. Subsequent patients then receive the drug at lower doses.~        -  Patients have a physical exam, blood and urine tests, and CT or MRI scans periodically~          to monitor safety and treatment effects. Leukemia patients also have bone marrow~          aspirates. Patients with a solid tumor may have an MRI. Children whose bones are still~          growing have X-rays of the lower legs periodically to monitor bone structure.~        -  Patients have additional blood studies to determine the amount of sorafenib in the~          blood, the effect of the drug on proteins and cells in the blood, and genetic~          differences that affect how individuals respond to the drug.~   "
162029|NCT01445067|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of BMS-927711 during~     migraine and non-migraine condition.~   "
162030|NCT01445054|"~     Background:~        -  Some breast cancer cells have specific proteins (receptors) on their surface that make~          the tumor grow faster than normal cells. One of these receptors is called HER2/neu.~        -  An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the~          cancer cell.~        -  Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has~          been attached to a tiny amount of Herceptin.~      Objectives:~      -To see if Indium-Herceptin provides information about the characteristics of the breast~     cancer in women whose tumors express HER2/neu and those whose tumors do not.~      Eligibility:~      -Women 18 years or older with primary or metastatic breast cancer who have not received~     treatment with herceptin for at least 6 months before enrollment into the study.~      Design:~        -  Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu~          status.~        -  Patients have a physical examination and review of medical records.~        -  Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma~          camera that detects the radioactivity in the Indium-Herceptin.~        -  Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine~          the best time to image after injection of Indium-Herceptin.~        -  Blood samples are obtained every day of scanning to monitor the effects, if any, of the~          Indium-Herceptin and to see how fast the agent leaves the body.~   "
162031|NCT01445041|"~     Further study details as provided by Duke University:~      Purpose: To evaluate the feasibility and safety of collecting and infusing autologous~     umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS).~      Study Rationale and Hypotheses: The major goal of this study is to determine whether infusion~     of autologous UCB cells in neonates with hypoplastic left heart syndrome is feasible and~     safe. The rationale for the study and for the potential benefit of UCB is based upon the~     following hypotheses:~        1. Infants with HLHS have significant neural injury evidenced from both prenatal and early~          antenatal brain MRI findings and infusion of UCB cells may lessen neural injury.~          Although the exact mechanism is unknown, UCB cell infusion may ameliorate neural injury~          via paracrine and anti-inflammatory effects that enhance post injury repair and may~          promote endogenous functional compensation of other cortical areas resulting in~          significant clinical improvements.~        2. UCB cells may also enhance cardiac function, minimize scar formation, and reverse~          detrimental remodeling after cardiac injury.~   "
162032|NCT01445028|"~     Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an~     important cause of retinal re-detachment. The purpose of this study is to evaluate the effect~     of oral isotretinoin, which inhibits the growth of cells responsible for proliferative~     vitreoretinopathy (PVR), on recurrent retinal detachment.~   "
162033|NCT01445015|"~     The study will utilize a stress management program delivered over 10 sessions that is~     hypothesized to result in decreased stress levels and improved coping strategies in an inner~     city adolescent asthma population. Participants will include adolescents ages 10-15 years~     with physician diagnosed asthma. The outcome measures will be obtained via psychosocial~     questionnaires and spirometry.~   "
162034|NCT01445002|"~     The study will evaluate the dose response of immunotherapy against grass pollen allergy using~     the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:~        -  skin prick testing~        -  grass pollen inhalation challenge~        -  antibody responses. In addition, the safety of subcutaneous application of BM32 will be~          evaluated.~   "
162035|NCT01444989|"~     Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh~     colored to erythematous, these lesions often present with scaling or crusting in sun damaged~     regions of the body. While they are physically visible and often palpable, these changes can~     also result in psychosocial changes in patients, including embarrassment about their skin or~     reduction in leisure activities to avoid further sun exposure. At the same time, AKs are~     known to progress in a significant number of cases to squamous cell carcinoma (SCC), a~     concern in terms of its metastatic potential.~      The primary purpose of developing this questionnaire is to examine how well it can~     potentially identify patients with actinic keratoses. However, since AK is associated with~     significant detriment to quality of life for validity/reliability assessment, the~     investigators propose to give a compilation of four self-assessment questionnaires (not~     specific to AK but validated for skin health in general) to subjects with at least one~     actinic keratosis and age- and sex- matched participants without AKs, defined as the control~     population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as~     well as a questionnaire composed of items specific to predisposition to AKs to be able to~     better assess the discriminatory power of the questionnaire.~   "
162036|NCT01444976|"~     There is no ideal sedation technique that can be used during Transesophageal Echocardiography~     (TEE), and the data concerning the effects of available sedation techniques on Heart Rate~     Variability (HRV) are limited. In this study the investigators aimed at comparing the effects~     of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV.~   "
162037|NCT01444924|"~     This study is a single-center, randomized, placebo-controlled, double-blind clinical trial.~     The purpose of this study is to evaluate the impact of pre-operative transverses abdominis~     plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for~     gynecologic cancers.~   "
162038|NCT01444911|"~     This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™~     Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water~     based lubricant, on sexual dysfunction, compared to the current standard care for women with~     no evidence of disease after treatment for gynecologic cancers.~      In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients~     are generally asked about sexual function. Those women who report sexual dysfunction will be~     given the option to enroll in the study. After enrollment, the Female Sexual Function Index~     (FSFI) and other quality of life surveys will be administered at baseline. The participants~     will be randomized to either the control arm, composed of standard of care therapy for the~     physical components of sexual dysfunction, or the experimental arm (VRP).~      Throughout the study, the participants will undergo physical exams to assess the rate of~     improvement in their comfort with pelvic exams and changes in vaginal length. They will also~     be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of~     Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of~     improvement in sexual function and quality of life.~   "
162039|NCT01444898|"~     Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a~     major source of morbidity and mortality in this population. It can lead to sleep apnea, cor~     pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that set~     it apart from other forms of obesity including insatiable appetite and food-seeking behavior~     which can be disruptive to home and school activities, and can cause severe social and~     psychological turmoil within families. PWS is also associated with unique hormonal~     abnormalities, most notably hyperghrelinemia. Ghrelin is a gut hormone produced in the~     stomach that stimulates food intake during a fast. It is hypothesized that the extremely high~     ghrelin levels in patients with PWS may cause or contribute to their insatiable appetite.~     Exenatide, a medication used in the treatment of type 2 diabetes mellitus in adults, appears~     to suppress ghrelin levels and cause weight loss. It was designed to mimic glucagon-like~     peptide 1 (GLP-1), an incretin hormone that stimulates insulin secretion and delays gastric~     emptying, among other effects. In the present study, the investigators will investigate the~     effects of a 6 month trial of exenatide in overweight adolescents with PWS. The investigators~     will quantify the changes in weight and body composition, as well as subjective measures of~     appetite, and concentrations of appetite-associated hormones. The investigators hypothesize~     that exenatide will improve weight, body composition, appetite, and plasma ghrelin levels~     during the treatment period.~   "
162043|NCT01444846|"~     Exposure to loud sounds can cause hearing loss. The purpose of this research study is to~     evaluate potential prevention of temporary changes in hearing that may occur after listening~     to music through an iPod or personal music player. We will measure temporary changes in~     hearing in subjects who listen to music and take either the study drug, SPI-1005, or a~     placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be~     taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione~     Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.~   "
162044|NCT01444833|"~     It is supposed that the significant metabolic effects (improvement of insulin sensitivity) of~     hypertension therapy with renin-angiotensin system (RAS) blockers in humans are mediated~     mainly via changes in abdominal adipose tissue. This project is aimed to confirm the~     hypothesis that increased concentrations of circulatory angiotensin II after angiotensin II~     receptor type I (AT1) blockade leads, via stimulation of angiotensin II receptor type II~     (AT2), to activation of adipogenesis and improvement of insulin sensitivity. Therefore, in~     hypertensive patients, the components of RAS and the parameters of insulin sensitivity on~     systemic (in plasma) and local (in adipose tissue and in its interstitial fluid) level will~     be studied. The main aim of the study is to identify the changes occurring in patient before~     and 6 months after the conversion of therapy from angiotensin converting enzyme (ACE)~     inhibitors to AT1 receptor blockers. Observed parameters will include gene expression of RAS~     components, parameters of insulin sensitivity, amount, and cellularity of adipose tissue~     obtained by biopsy, evaluation of direct production of cytokines and angiotensins into the~     interstitial fluid of fat tissue obtained by microdialysis and evaluation of the selected~     parameters in plasma.~   "
162045|NCT01444820|"~     In North America, around a quarter a million men are diagnosed with prostate cancer every~     year, and about 31,000 patients will die of their disease each year. Like other western~     countries, the incidence in Canada has increased due to an aging population and prostate~     specific antigen (PSA) screening. This has led to a significant demand on cancer care~     services for these patients. Prostate cancer patient with high risk features are more often~     treated with external beam radiation therapy (EBRT) plus two to three years of hormonal~     manipulation (luteinizing hormone-releasing hormone [LHRH] agonist). The most common~     radiation dose treatment for these patients is 74-78 Gy in 37-39 daily fractions of 180-200~     cGy for a treatment length of 7.5 weeks. This fraction size is believed to offer the best~     balance between desired tumour kill and unwanted normal tissue injury. Larger fraction sizes~     of more than 250 cGy (hypofractionation) are usually avoided for curative therapy because~     late reacting normal tissues. However prostate cancer cells have a unique radiobiology~     characteristic that suggests that hypofractionated radiotherapy is more efficient at prostate~     tumour killing than standard fractionation is, and will produce equivalent tumour control~     with a lower total dose and a shorter overall treatment time. Improved target localization~     techniques and conformal radiation therapy technology have allowed for dose escalation and~     hypofractionated radiation delivery in these circumstances with minimal or no increased~     toxicities.~      This trial is designed to determine whether high risk prostate cancer patients can be safely~     treated with a dose escalation hypofractionated radiation therapy in 5 weeks as opposed to~     the usual 7-8 weeks. These patients will be randomized to either the usual 76 Gy in 38~     fractions or 68 Gy in 25 fractions. 3D-Conformal Radiotherapy (3D-CRT) or Intensity Modulated~     Radiotherapy (IMRT) will be used to deliver the required radiation dose. Patients will also~     receive 28 months of androgen deprivation therapy (LHRH agonist). The primary outcome of the~     study is the acute and delayed toxicity and the secondary outcomes include biochemical~     failure, prostate specific mortality rate, bone metastases free survival, the prognostic and~     predictive value of several biological variables: presence of the PTEN deletion; expression~     of FoxP3 gene variants, topoisomerase 2α and cancer testis antigens; expression of X~     chromosome-linked micro-RNAs; presence of TMRSS2-ERG gene fusion and quality of life. It is~     planned to recruit 250 patients to this study.~   "
162046|NCT01444807|"~     Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to~     metastasectomy~   "
162047|NCT01444794|"~     The purpose of the protocol is to assess the responder rate as defined by the achievement of~     the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A)~     injection cycle in accordance with routine practices.~   "
162048|NCT01444781|"~     This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722).~     The objectives are:~        -  To describe the antibody persistence to any antigen contained in the investigational~          DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose~        -  To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep~          B-PRP-T or Infanrix hexa™ vaccine.~        -  To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.~   "
162049|NCT01444768|"~     This study will evaluate various performance metrics of emergency department operations after~     the implementation of computerized physician order entry in an academic emergency department.~   "
162050|NCT01444755|"~     The aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen~     in patient with resectable locally advanced gastric cancer in comparison with surgery alone.~   "
162051|NCT01444742|"~     The goal of this clinical research study is to learn if clofarabine when given in combination~     with cytarabine can help to control myelodysplastic syndrome (MDS) after the disease could~     not be controlled with standard therapy. The safety of this treatment will also be studied.~      Clofarabine is designed to interfere with the growth and development of cancer cells.~      Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer~     cells and stop the DNA from repairing itself.~   "
162052|NCT01444729|"~     An agreement has been made to conduct a post-approval commitment study that provides~     supplementary information relating to the use of Xiapex® as well as other non-pharmacological~     treatments for Dupuytren's contracture by health care professionals in a real world clinical~     setting.~   "
162053|NCT01444716|"~     The goal of this clinical research study is to learn if ofatumumab can help to control CLL.~     The safety of this drug will also be studied.~      Ofatumumab is designed to bind to the surface of the leukemia cells . This may cause the~     leukemia cells to die.~   "
162054|NCT01444703|"~     The investigators propose to test the hypothesis that pre-operative gargling with licorice~     reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal~     tubes compared to placebo after surgery through the first four post-extubation hours.~   "
162055|NCT01444690|"~     The purpose of this study is to assess the efficacy and tolerability of orally administered~     dimiracetam for 10 weeks to AIDS patients under treatment with antiretroviral agents~     presenting a disease and /or treatment related neuropathic pain.~   "
162056|NCT01444677|"~     The purpose of this study is to investigate the safety and tolerability of MB12066 after a~     single or multiple oral dose and to investigate the pharmacokinetic characteristics of~     MB12066 after a single or multiple oral dose.~   "
162057|NCT01444664|"~     The purpose of this prospective registry is to determine if patients harboring intracranial~     aneurysms have any predictive markers between aneurysm wall tissue, cerebrospinal fluid and~     blood plasma.~   "
162061|NCT01444612|"~     Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism~     (PE), is a common post-operative complication. The effectiveness of fondaparinux compared~     with other injectable anticoagulants in VTE following major orthopedic and abdominal surgery~     has been evaluated in database studies; however, the effectiveness of injectable~     anticoagulant medications following cancer-related surgeries in the practice setting has not~     been as well documented.~      The objective of this study is to analyze patient records from a national hospital database~     and compare the outcomes and costs between four types of injectable anticoagulant medications~     that were prescribed for the prevention of VTE following cancer-related surgery. This~     analysis will assess and quantify the outcomes, resource utilization, and cost of care for~     patients receiving fondaparinux, enoxaparin, dalteparin or unfractionated heparin. The~     outcomes of interest include the occurence of VTE, rates of major bleeds, medical resource~     utilization, and total costs (medical plus pharmacy).~      The source of data for this study is the Premier Perspective Database™. This hospital claims~     database links de-identified inpatient medical, pharmacy, and billing data from more than 500~     hospitals.~      This study is a retrospective cohort study that uses propensity score matching to adjust for~     the differences between the numbers of patients treated with each medication.~   "
162062|NCT01444599|"~     Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS)~     is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap~     fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined~     with more than 70% plaque burden and less than 4mm² minimal lumen area (MLA) by IVUS.~     Fractional flow reserve (FFR) is an established index of the physiological significance of a~     coronary stenosis. Recent large scale trials demonstrated FFR guided PCI showed favorable~     clinical outcomes. VH-IVUS represents anatomical severity, but FFR represents functional~     severity of CAD. Few studies reported relevance between two tests. Aim of this study was to~     investigate whether the geometry and composition of lesions were different under FFR~     criteria.~   "
162063|NCT01444586|"~     This is a local, prospective, multicenter, non-interventional, observational study. Primary~     objective is to describe how in real life thromboprophylaxis is carried out after the~     discharge from a hospital in the patients who undergo elective knee and hip replacement and~     who receive Xarelto during hospitalization.~   "
162064|NCT01444573|"~     The investigators hypothesized that very lenient rate control is not inferior to strict or~     lenient rate control assessed by implantable continuous ECG monitor for preventing~     cardiovascular hospitalization and mortality in patients with long-standing persistent or~     permanent atrial fibrillation~   "
162065|NCT01444560|"~     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length,~     capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs~     (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of~     complementarity. miRNAs have recently been shown to play pivotal roles in diverse~     developmental and cellular processes and linked to a variety of skin diseases and cancers. In~     the present study, the investigators examines the expression profiles of miRNA machinery~     components such as miRNA maturation and transport factors, microprocessor complex and RISC~     subunits in cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi.~   "
162066|NCT01444547|"~     The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy~     with cisplatin and paclitaxel in esophageal cancer~   "
162067|NCT01444534|"~     The use of smartphones has increased substantially in recent years. Apart from making phone~     calls and sending short messages, these smartphones can also function as a computer on which~     one can download computer programs (the so-called applications). Health applications are~     increasingly developed and may be a new tool for education of patients and communication~     between healthcare providers and their patients, possibly contributing to a better care for~     patients with chronic diseases such as diabetes.~      Since the number of patients with diabetes mellitus and the number of people having a~     smartphone are rising, it is investigated whether applications on smartphones may be used to~     support lifestyle changes and self-monitoring of bloodglucose control, possibly leading to an~     improved glycaemic regulation in the group of patients with diabetes mellitus.~      Large randomized controlled trials have shown that a stable glycaemic regulation is important~     to reduce morbidity and mortality and to improve quality of life (QOL). Self-monitoring of~     blood glucose is an important tool to realize an optimal glycaemic regulation in patients~     with type 1 diabetes mellitus (T1DM). Apart from a good glycaemic control, QOL is essential~     in diabetic patients. A reduced QOL is associated with progression of the disease, worse~     intake of medication and an increased mortality in patients with T1DM and diabetes mellitus~     type 2.~      The increasing costs associated with the rising number of diabetic patients makes that~     research investigating cheaper alternatives in the care for patients with diabetes are~     needed. The switch from a written logbook to an electronic logbook may simplify the care for~     diabetes patients. By means of an application all variables (food intake, physical exercise,~     glucose day curves, insulin units, reminders to take medication) are integrated in one~     program. But whether this digitalisation also improves QOL of the patient is still unclear.~      Therefore the aim of this study is to evaluate the effect of a diabetes application on the~     (QOL) for type 1 diabetic patients.~   "
162068|NCT01444521|"~     The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy~     with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal~     dosage of combination chemotherapy.~   "
162069|NCT01444508|"~     In order to reduce bloodloss and need for transfusion to investigate the effect of colloid~     and crystalloid on coagulation assuming no difference between the groups.~   "
162070|NCT01444495|"~     The purpose of this study is to establish the influence of time-interval between preoperative~     hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years),~     local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical~     resection rate (R0) in patients with locally advanced rectal cancer operated on according to~     TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents~     are evaluated to assess response to radiotherapy.~   "
162096|NCT01444157|"~     When facing life threatening illness such as advanced cancer palliative care is needed to~     improve quality of life of patients and their families through the prevention and relief of~     suffering. Palliative care at an early stage prevents the development of problems and~     symptoms, but time, resources and experience are needed in the primary care sector in Denmark~     to deal with the problems families experiencing life with advanced cancer are facing. The~     aims of this study are to test, evaluate and further develop interventions that can help~     identify and assess problems, resources and opportunities of families experiencing life with~     advanced cancer, and on this background to help the families cope with their situation in~     cooperation with healthcare professionals to an extent where the family's quality of life~     increases, their physical and psychosocial problems are relieved, their symptoms of anxiety~     and depression are reduced, family satisfaction with health professionals are increased and~     acute readmissions to hospital are prevented.~   "
162071|NCT01444482|"~     The safety of parenterally administrated investigational vaccine (commercial influenza~     vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly~     (age 65-75), will be investigated in the study. Moreover, the study aims to study parameters~     associated with improved protection against clinical disease in elderly. Such parameters~     include HI-titres, a balanced Th1/Th2 response as well as a functional cellular immune~     response.~      Vaccination will start in 22 healthy adults receiving the investigational vaccine.~     Vaccination of elderly will be initiated only after demonstration of safety in adults. 88~     healthy elderly volunteers will be vaccinated, 44 will receive the seasonal influenza vaccine~     alone and 44 will receive the investigational vaccine. Vaccines will be administrated~     intramuscularly in the upper arm. One dose will be administered to each volunteer included in~     the study. Blood samples for basic immunological assessments of cellular and humoral immunity~     will be taken at day 0, 7, 28, 90 and 150.~      The investigational vaccine is equal to one standard human dose of a commercial seasonal~     influenza vaccine to which 50 µg of adjuvant Matrix M has been added.~   "
162072|NCT01444469|"~     Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in~     asthmatic patients. Current treatments for asthma attacks are not completely effective and~     new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung~     infections have also been associated with asthma attacks. However, the role for bacteria is~     uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not~     recommend the routine use of antibiotics. The investigators would like to investigate whether~     or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that~     has been used for many years in the treatment of respiratory disease, might be of benefit in~     asthma attacks. As there is some evidence that azithromycin has anti-viral properties this~     may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect~     of azithromycin on asthma attacks this will help us to show whether or not azithromycin~     should be recommended during an acute asthma attack in addition to the usual care that is~     provided to these patients as it may help them recover quicker from the exacerbation. The~     investigators will also be able to look at why azithromycin may be effective - if it is~     having an anti-bacterial and/or anti-viral effect.~   "
162073|NCT01444456|"~     This is a multicenter, international, prospective, observational study of patients who are~     receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian,~     prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are~     receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to~     treat symptomatic anaemia.~      Quality of Life will be assessed electronically with the aim of estimating improvement in~     quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an~     increase in haemoglobin (Hb) of ≥1 g/dL~   "
162074|NCT01444443|"~     The objective of this in-clinic study is to test our closed-loop glucose control system in~     patients with type 1 diabetes.~   "
162075|NCT01444430|"~     The purpose of the study is to evaluate the safety of Symbicort compared to inhaled~     corticosteroid alone during 6 months in adult and adolescent patients with asthma~   "
162076|NCT01444417|"~     The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of~     thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured~     by durable platelet response.~   "
162077|NCT01444404|"~     First in human, open-label, sequential dose escalation and expansion study of AMG 820 in~     subjects with advanced solid tumors.~   "
162078|NCT01444391|"~     The objective of the study is to evaluate the safety and efficacy of the Acclarent~     Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under~     local anesthesia delivered by iontophoresis in an office/clinic setting.~   "
162079|NCT01444378|"~     To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent~     System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of~     subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral~     artery (SFA) and/or the native proximal popliteal artery (PPA).~      CAUTION: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL~     Peripheral Self-Expanding Stent Systems are investigational devices. Limited by Federal~     (U.S.) law to investigational use only.~   "
162080|NCT01444365|"~     To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal~     Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of~     the knee.~   "
162081|NCT01444352|"~     This study is designed to evaluate the safety, tolerability, and immunogenicity of an~     investigational pneumococcal vaccine in healthy adult volunteers.~      Primary Objective:~        -  To evaluate the safety and tolerability of an investigational pneumococcal vaccine.~      Observational Objective:~        -  To evaluate the immunogenicity of an investigational Pneumococcal vaccine.~   "
162082|NCT01444339|"~     This study is designed to evaluate the safety, tolerability, and immunogenicity of two~     investigational pneumococcal vaccines at three dose levels in healthy adults.~      Primary Objective:~      - To evaluate the safety and tolerability of two investigational pneumococcal vaccines.~      Observational Objective:~      - To evaluate the immunogenicity of the investigational pneumococcal vaccines.~   "
162097|NCT01444144|"~     The purpose of this study is to track surgical outcomes and post-operative course in patients~     55 years of age or older treated for ankle fractures.~   "
162098|NCT01444131|"~     The purpose of this study is to test whether the addition of a nicotine patch to varenicline~     increases smoking cessation success rate and whether the combination is safe.~   "
162099|NCT01444118|"~     The vaccine contains humanized recombinant antigen (Epithelial Growth Factor) and an~     adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to~     removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is~     prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation~     of tumour cell. A Phase III clinical trial on the EGF vaccine is ongoing in Cuba. The result~     from previous studies demonstrated positive correlation between extended survival and immune~     response against the vaccination in the late-stage NSCLC patients' age below 60 with improved~     quality of life. The purpose of this international Phase III trial is to determine whether~     the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment~     of stage IIIB/IV NSCLC patients compared to standard treatment and supportive care.~   "
162083|NCT01444326|"~     Inflammation and endothelial dysfunction are being increasingly recognized as key etiological~     factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD).~     These pro-atherogenic states are strongly correlated and often found co-segregating among~     individuals with obesity and the metabolic syndrome. There is increasing evidence to support~     the use in clinical practice of these novel markers of atherosclerosis and CVD risk. Recent~     data from the JUPITER study (Justification for the Use of Statins in Primary Prevention: An~     Intervention Trial Evaluating Rosuvastatin) has provided undisputable evidence that treating~     patients with elevated plasma CRP concentrations, a marker of systemic subclinical~     inflammation, leads to marked reduction in the risk of CHD even in patients with highly~     desirable LDL-C levels. There is also accumulating evidence associating endothelial~     dysfunction, which is defined as incapacity of the arteries to vasodilate when required, to~     an increased risk of CVD. While there are more and more studies on how diet affects~     inflammation and endothelial function, the impact of dairy consumption per se on these novel~     risk factors for CVD has not been well characterized.~      The purpose of this study was to investigate the impact of dairy consumption on markers of~     inflammation and other risk factors in men and women with low grade systemic inflammation.~   "
162084|NCT01444313|"~     The purpose of this study is to examine the short-term protective effect of Ultra-Violet~     filtering contact lenses on macular pigment ocular density.~   "
162085|NCT01444300|"~     Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in~     people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages~     the myelin insulation around nerves which slows conduction of messages from the brain to the~     leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin.~     Recent research indicates that imbalance in MS is in large part caused by poor conduction by~     the nerves that transmit information about the position of the legs to the brain. It is~     therefore likely that, by improving nerve conduction, dalfampridine will also improve~     imbalance in people with MS. Dalfampridine will be administered in this study by the same~     route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve~     walking speed in people with MS. The proposed pilot study will examine the effects of~     dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This~     small pilot study will help to show if dalfampridine improves imbalance in MS and will guide~     the design and implementation of a larger full scale study to definitively determine if~     dalfampridine improves balance and prevents falls in people with MS.~   "
162086|NCT01444287|"~     The purpose of this research is to measure daytime open-eye response to wearing of narafilcon~     B lenses.~   "
162087|NCT01444274|"~     This will be an observational, prospective, non-randomized, pilot study to gain initial~     device experience on a novel space-occupying device in persons who are overweight or obese.~     No formal hypothesis testing will be conducted.~   "
162088|NCT01444261|"~     With early screening and appropriate iron supplementation, iron deficiency in the first year~     of life can be prevented in breastfed infants.~   "
162089|NCT01444248|"~     The study design of this trial is open-label, randomized, multi-center, parallel-group study.~   "
162090|NCT01444235|"~     Comparison of the cardioprotective effects and safety of two cardioplegic solutions~     (solutions used during a cardiac arrest in the heart surgery) in patients undergoing~     cardiopulmonary bypass for coronary artery bypass surgery.~   "
162091|NCT01444222|"~     Right-sided heart disease has an important impact on the prognosis of patients with valvular~     heart disease. Up to now, Tricuspid Valve Regurgitation (TR) and right heart hemodynamics~     have not been extensively investigated. However, it is plausible that a significant degree of~     TR and the associated volume-overload of the right ventricle cause significant right~     ventricular wall stress. Although minor TR generally is well tolerated, major TR can lead to~     clinical symptoms, right ventricular dilatation and ultimately right ventricular heart~     failure. Up to now, the investigators do not dispose of any tools to diagnose and anticipate~     this unfavourable evolution. Nevertheless it is likely that right ventricular failure is~     preceded with a subclinical dysfunction of the right ventricle and a possibly reversible~     change in contractility of the myocardium.~      Recently, new techniques to evaluate the systolic function, the contractility and the~     hemodynamics of the heart have become available.~      First, this study will help us assessing the feasibility and accuracy of several imaging~     modalities in right-sided heart pathology with focus on TR and right heart myocardial~     performance.~      Second, this study will contribute to a better understanding of the hemodynamic effect of~     volume-overload and/or pressure-overload of the right ventricle. It will clarify the~     behaviour of TR, the evolution of right ventricular myocardial contractility and dysfunction~     during exercise and its impact on exercise capacity. By doing this, discrimination between~     well tolerated and ill-tolerated TR will be possible, thus identifying patients who might be~     eligible for treatment (medical, corrective, …).~   "
162092|NCT01444209|"~     This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo~     implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor~     response to treatment will be monitored as well as change in visual fields, associated~     adverse effects, progression free survival and patient reported outcomes.~   "
162093|NCT01444196|"~     The primary objective of the study is to assess the dosis of DL which is sufficient to~     inhibit cold urticaria symptoms.~   "
162094|NCT01444183|"~     The study will examine whether a stress reduction intervention reduces the number of seizures~     in people with drug resistant epilepsy.~   "
162095|NCT01444170|"~     The objectives of this study are to assess the effectiveness of a nutritional supplement on~     muscle functional recovery following induced muscle damage from high intensity resistance~     exercise. The investigators hypothesize that a short-term dietary supplementation will~     significantly improve muscle functional recovery following an intense bout of eccentric~     exercise compared to a placebo.~   "
162100|NCT01444105|"~     Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT~     procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.~   "
162101|NCT01444092|"~     A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease~   "
163520|NCT01425450|"~     The study aims to:~        -  study the safety of the drug (HF1020) in healthy male adults~        -  study how well the study drug (HF1020) is tolerated in healthy male adults~        -  find the maximum dose that is tolerated in healthy male adults~   "
162102|NCT01444079|"~     Liver is an organ that is well-known for its immune tolerant capacity. However, there were~     still controversial issues about the impact of immunologic challenge after liver~     transplantation on the graft function. Different results of graft function affected by~     immunologic factors such as pre-transplant panel reactive antibody (PRA) status,~     pre-transplant positive lymphocyte cross match (LCM), or post-transplant circulating donor~     specific antibody (DSA) has been reported according to individual institutes. There was no~     trial for presenting anti-donor lymphocyte antibody change after liver transplantation.~      The investigators designed this study to analyze the correlation between pre- and~     post-transplant immune status (PRA, LCM), and graft survival / rejection episode. Also, the~     investigators will find aspects of anti-donor lymphocyte antibody change after liver~     transplantation.~   "
162103|NCT01444066|"~     The goal of our study is to determine if stretching the esophagus with a rubber dilator helps~     patients with swallowing difficulties who have a normal appearing esophagus on upper~     endoscopy. In order to do this we will perform a randomized controlled study, where patients~     will undergo esophageal dilation (stretching) with different diameter dilators. We will~     measure change in symptom severity between baseline (prior to dilation) and 1, 3, 6 and 12~     months after the procedure~   "
162104|NCT01444053|"~     The purpose of this study is to examine the long term effect of ultra-violet filtering~     contact lenses on macular pigment density (MPOD) and accommodative function.~   "
162105|NCT01444040|"~     Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices~     versus medical therapy in eyes of subjects with primary open-angle glaucoma,~     pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.~   "
162106|NCT01444027|"~     In recent years, the demand for home hospice care has grown rapidly. Family members and~     friends who act as informal caregivers are essential to the provision of palliative care~     services; however, this role is not without adverse effects on the caregivers themselves. It~     is well documented that emotional needs of individuals caring for dying persons in their home~     are not well attended, and interventions aiming to provide support to informal hospice~     caregivers are notably lacking. In this context, problem solving therapy (PST) provides an~     overall coping process that fosters adaptive situational coping and behavioral competence.~     The investigators are conducting a randomized controlled trial to fully evaluate the PST~     intervention for informal hospice caregivers. Additionally, the investigators aim to evaluate~     how the modality of the intervention (face to face vs video) impacts its effectiveness. This~     investigator team is conducting a 4-year randomized trial study in which hospice caregivers~     will be randomly assigned to a group receiving standard hospice care with the addition of~     social support interactions (attention control group) or a group receiving standard hospice~     care with the addition of the problem solving intervention delivered face to face~     (intervention group 1) or a group receiving standard hospice care with the addition of the~     problem solving intervention delivered via video (intervention group 2). The specific aims~     include an assessment of the impact of PST on caregiver quality of life, problem solving~     ability, and caregiver anxiety.~   "
162107|NCT01444014|"~     The aim of the study is to find out if the experimental medicine, YF476, can make gastric~     carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur~     mainly in patients with chronic atrophic gastritis (CAG), a condition in which the~     acid-producing cells in the lining of the stomach can't make acid. Acid production is~     controlled by gastrin, a hormone (chemical messenger) that's released into the bloodstream.~     If the stomach can't make acid, blood levels of gastrin rise. High blood levels of gastrin in~     patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow and,~     over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually benign,~     but they can become malignant. Therefore, patients with CAG and gastric carcinoids have the~     inside of their stomach checked regularly, by gastroscopy, to see if the gastric carcinoids~     need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of which is a~     mini video camera, which enables the user to inspect the lining of the stomach and a 'snare'~     to take samples of tissue (biopsies). YF476 (netazepide) is a gastrin receptor antagonist~     (blocks the effects of gastrin), so it's a potential new medical treatment for gastric~     carcinoids in patients with CAG. Up to 10 of these patients will take YF476 daily for up to~     12 weeks. They'll make up to seven outpatient visits for tests, including checks on the~     safety of YF476 and up to four gastroscopies. At each gastroscopy, the gastric carcinoids~     will be measured and biopsies taken for laboratory tests. Patients will take up to 24 weeks~     to finish the study.~   "
162108|NCT01444001|"~     This study was designed to evaluate the safety, tolerability, and immunogenicity of three~     doses of an investigational pneumococcal vaccine in healthy adult volunteers.~      Primary Objective:~        -  To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.~   "
162109|NCT01443988|"~     Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus~     medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative~     glaucoma, or ocular hypertension naïve to medical and surgical therapy.~   "
162110|NCT01443975|"~     The purpose of this study is to clinically evaluate the use of the x-pander device.~   "
162111|NCT01443962|"~     During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen~     saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory~     parameters include oxygenation. So applying PEEP could improve the regional brain oxygen~     saturation (rSO2)~   "
162121|NCT01443832|"~     The study sought to investigate the effect of lowering phytic acid in fonio porridge with~     phytase activity naturally occurring in wheat flour on iron absorption using labelled stable~     isotopes of iron. The study population is represented by 16 apparently healthy young Beninese~     women aged 18-30 years recruited based on their willingness to participate and according to~     inclusion criteria. Test meals consisted of fonio porridges fortified with isotopically~     labelled [57Fe] or [58Fe] ferrous sulfate with and without wheat flour. Meals were~     administered to fasting subjects on two consecutive days using a randomised crossover design:~     half the subjects received the test meal on the first day and the control on the second day~     and vice versa. Venous blood sample were collected (day 1 and day 14) for iron status and~     iron absorption measurement. Iron absorption measurement is based on erythrocyte~     incorporation of iron stable isotope labels 14 days after intake of the labelled test meals~     and calculated based on isotope-dilution.~   "
162112|NCT01443949|"~     Background:~      - The risk for becoming addicted to drugs varies from person to person, even among those who~     use similar drugs in a similar way. Studies suggest that certain personality traits seen in~     people with drug addiction may be present before drug use. These traits include responding~     differently to rewards or impulsivity. Early use of drugs (before age 15) is also associated~     strongly with drug addiction later in life. Researchers want to study teenagers with and~     without certain behavioral problems, including those who have used drugs and those who have~     not. This may help them better understand behaviors that might predict future drug addiction.~      Objectives:~      - To understand brain function in teenagers who may be at a higher risk than others to drug~     addiction.~      Eligibility:~        -  Teenagers between 13 and 17 years of age who fit into one of four groups:~        -  Have never or rarely used drugs~        -  Have never or rarely used drugs and have conduct or behavior disorders~        -  Have used drugs on many occasions~        -  Have used drugs on many occasions and have conduct or behavior disorders~      Design:~        -  Participants will be screened with a medical history, and physical and neurological~          exams. They will also have blood and urine tests. Participants will answer questions~          about past drug use and any current medications. They will also have a breathalyzer and~          carbon monoxide breath test to check for recent drug and alcohol use.~        -  This study requires four visits to the clinical center for magnetic resonance imaging~          (MRI) scans and other tests.~        -  The first study visit will include training for the MRI scans. Participants will~          practice the tasks in front of a computer and in a mock (fake) MRI machine. Participants~          will also be asked several questions about their personality and past experiences.~        -  Researchers will test changes to tryptophan and dopamine levels. Both of these chemicals~          affect decision making and brain function. On the three study visits, participants will~          have the following tests in a randomly selected order. One study will be done at each~          visit.~        -  MRI scans with changes to dopamine and tryptophan levels~        -  MRI scans with changes to dopamine only (with placebo)~        -  MRI scans with changes to tryptophan only (with placebo)~        -  Participants will be monitored with frequent blood draws and other tests during the~          study visits.~   "
162113|NCT01443936|"~     This is a Phase 1 randomized, single center, dose-escalation study designed to evaluate the~     safety and immunogenicity of live, replication competent recombinant Adenovirus type~     4-H5N1Influenza Vietnam 1194 Hemagglutinin (HA) (Ad4-H5-Vtn). Determining the optimal route~     and dose for this recombinant platform will greatly accelerate investigations of this vector~     as an influenza vaccine and an HIV vaccine platform.~      Intranasal and tonsillar administration of the vaccine will be separately assessed. The oral~     enteric-coated capsule will also be assessed in 10 outpatients using similar blood sampling~     for comparison. The Ad4-H5-Vtn orally administered as enteric-coated capsules has already~     been evaluated in an ascending dose Phase 1 study, in dosages as high as 10(11) viral~     particles (vp).~      The primary goal of this study is to evaluate safety of ascending dosages of the Ad4-H5-Vtn~     vaccine following intranasal and tonsillar administration. A dosage or dosages will be~     selected to further evaluate the humoral, cellular, and mucosal immune responses against both~     the vector and the inserted gene. The Ad4-H5-Vtn will be initiated at 10(3) vp. Once safety~     is established at the initial dose, a second round of testing will begin at the next ten-fold~     higher dose. The Ad4-H5-Vtn vaccine will be assessed in three participants at each dosage~     level. The maximum viral dose administered by the tonsillar route will be 10(8) vp.~      In addition to clinical and laboratory monitoring of safety, the principal assessments will~     be shedding of the Ad4-H5-Vtn virus in rectal, cervicovaginal, throat, and nasal swabs, and~     assessment of the antibody (mucosal and systemic) response to the HA and to the Ad4 virus.~     When safety has been confirmed in all three participants at a given dosage level, the next~     higher dose group is enrolled. If one grade 3 or greater toxicity (or pre-specified Grade 2~     toxicity, see Section 3.4) attributable to the vaccine is observed, the group will be~     expanded at that dose. If a second attributable grade 3 or greater toxicity (or pre-specified~     Grade 2 toxicity, see Section 3.4) is observed, the dose will be reduced one level and the~     group will be expanded. Up to 25 Ad4-seronegative individuals will be enrolled at the maximum~     tolerated dose to fully evaluate safety and immunogenicity in the protocol.~      All participants will be followed for 28 days following immunization, and again at 8 and 26~     weeks to evaluate any long-term toxicity and persistence of immunity. Tonsillar Participants~     will receive a booster dose of vaccine [SK1]at the 26-week visit and be seen for follow-up~     visits at Weeks 30 and 34. Household and intimate contacts will also be enrolled and~     monitored for Adenovirus and HAI antibodies.~   "
162114|NCT01443923|"~     Background:~      - Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN~     and ribavirin. However, this treatment is not very effective in people with a serious type of~     HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV)~     coinfection. Researchers want to add a new drug, boceprevir to see if it can improve~     treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination~     with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV~     genotype 1 infection only, and is currently being studied in those with HIV and HCV.~      Objectives:~      - To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people with~     HCV monoinfection compared to those with both HIV and HCV infections.~      Eligibility:~        -  Individuals at least 18 years of age who have HCV genotype 1 infection, and have not~          received interferon treatment for HCV~        -  Half of the study participants will also have HIV infection.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests.~        -  Participants will also have heart and liver function tests, and answer questions about~          mood and depression.~        -  Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to~          inject under the skin weekly.~        -  Two weeks after starting treatment, participants will have blood tests to study the~          treatment.~        -  Four weeks after starting treatment, participants will start taking boceprevir three~          times a day.~        -  Participants will have regular study visits with blood samples and other tests. The~          length of therapy will depend on the level of virus detected in the blood at several~          clinic visits. Those who do not respond well to the medicines at 12 weeks will stop~          treatment. The full length of treatment is 48 weeks.~   "
162115|NCT01443910|"~     This study is part of an effort to learn about interactions between doctors and patients. We~     aim to understand how women feel about techniques that doctors use to talk with patients~     about their weight. We are studying women s reactions to these techniques using a virtual~     reality version of a doctor s office to create as realistic a model of a doctor s visit as~     possible. This can help us better understand what happens during real doctor s visits.~      Women between the ages of 20 and 50 who are currently overweight may be eligible for this~     study. Participants will be recruited from the Washington D.C. area. This is not a weight~     treatment study.~      Participants undergo the following procedures:~        -  Complete an online questionnaire about themselves, their experiences, and their thoughts~          about their weight~        -  Participate in activities in a virtual reality environment in which they interact with a~          virtual doctor in a virtual clinical scenario. For this experiment, participants wear a~          head-mounted display that allows them to see the virtual world images.~        -  Fill out a questionnaire after completing the virtual reality activities. This~          questionnaire includes information on the participants' virtual reality experience, the~          information provided in the experience, and additional questions about themselves and~          their thoughts.~   "
162116|NCT01443897|"~     This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase~     their vitamin D2 content are actually a good source of vitamin D when consumed daily with a~     meal (lunch). The mushrooms will be provided cooked along with a meal which will be a~     standard, pre-packaged frozen meal. We also hope to learn if the resulting improvement in~     vitamin D status affects the immune system by decreasing it's level of activation, which may~     be abnormally elevated in vitamin D deficiency.~   "
162117|NCT01443884|"~     The goal of the study is to determine whether grape consumption can reduce the risk of~     cardiovascular disease by reducing the presence of inflammatory molecules and positively~     altering cholesterol levels, lipid profiles, and immune cell responses.~   "
162118|NCT01443871|"~     The purpose of this study is to examine and compare electroencephalography (EEG) changes in~     human subjects directly after inhalation of essential oils from five Thai aromatherapies. The~     investigators hypothesize that essential oils from Thai aromatherapies may influence the~     human EEG involving emotional relaxation particularly alpha wave EEG.~   "
162119|NCT01443858|"~     The purpose of this study is to evaluate whether meclizine, an antihistamine used to prevent~     or treat motion sickness, can help smokers quit smoking. This study will also investigate the~     potential relationship between genes you have inherited and success in quitting smoking.~   "
162120|NCT01443845|"~     To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination~     (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.~   "
162122|NCT01443819|"~     The purpose of this research study is to look at two of the common forms of treatment for~     this condition: physical therapy and epidural steroid injection. The investigators are~     attempting to evaluate whether or not physical therapy alone, or epidural steroid injections~     alone, are effective in treating this condition. The investigators will also try to determine~     whether or not one of these treatments is better than the other for the treatment of~     herniated discs with nerve injury (radiculopathy).~   "
162123|NCT01443806|"~     The aim of this study is to evaluate the conversion of OP to OC in individual X and the~     family member of individual X. The investigators hypothesize that one or more of the single~     nucleoprotein polymorphisms (SNPs) of the CES1 gene represent a clinically important~     functional polymorphism.~   "
162124|NCT01443793|"~     The objective of this active surveillance study is to make available crucial data about~     epidemiology, serotype distribution, and longitudinal pattern of antibiotic susceptibility of~     nasopharyngeal strains of Streptococcus pneumoniae carried in the population of healthy~     children aged less than years and living in the area of Milan and surroundings, Lombardy,~     Italy.~        -  To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus~          pneumoniae in healthy children aged less than 5 years living in the area of Milan,~          Italy;~        -  To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae~          strains in healthy children aged less than 5 years~      Secondary objectives:~        -  To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains~          in healthy subjects less than 5 years old;~        -  To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in~          healthy children;~        -  • To evaluate the possible impact of vaccination policy in the referenced population.~   "
162125|NCT01443780|"~     The dietary supplements selenium and Q10 has been evaluated in a double blind~     placebo-controlled study in an elderly Swedish population. The hypothesis is that as a~     majority of Northern Europeans suffers insufficient levels of selenium that is used by the~     cell in the building of at least 25 different enzyme systems in the body, and that the cell~     need presence of Q10 in order to produce the selenium containing enzymes, we wanted to~     evaluate the effect of a combined intervention of the two supplements in an elderly~     population in Sweden. All participants were controlled every 6 months, and the intervention~     was 48 months in each participant. Besides blood samples, echocardiography and cardiac~     natriuretic peptides were analyzed at start, every 6 months and at end of the study.~   "
162126|NCT01443767|"~     The purpose of this study is to determine the measuring accuracy of the truly non-invasive~     method estimated continuous cardiac output (esCCO) against the reference method pulse contour~     analysis of the arterial waveform (Picco) in partial liver resection. esCCO is calculated~     using the pulse wave transit time, which is defined as the time between the R-wave of the ECG~     and a 30% increase of the differentiated pulseoximetry waveform.~   "
162127|NCT01443754|"~     The present study is designed as a prospective, single centre, open label, observational~     trial.~      The study will collect information about the medical care patients receive during their~     planned procedure(s). No new testing or procedures will be done.~      Patients elected for hybrid revascularization will be asked their written consent to the use~     of their personal data.~      Left internal mammary artery to the Left Anterior Descending Coronary Artery~     (LIMA-LAD)surgical revascularization will be performed first, followed by percutaneous~     revascularization of the other vessels in the frame of the same hospitalization.~      After discharge patients will attend clinic visits at 30 days and 12 months, as per usual~     clinical practice, and will be contacted by phone at 6 months after procedure. Angiographic~     follow-up will be performed in symptomatic patients, as clinically indicated.~   "
162128|NCT01443741|"~     Evaluation of interests of the functional insulin therapy (FIT Therapy) on metabolic control,~     hypoglycemia prevention and life quality of diabetics children insulin-dependent treated with~     insulin pump.~   "
162129|NCT01443728|"~     This study aims to answer the question whether oral vitamin D supplementation can decrease~     lung complications in children and adolescents with sickle cell disease. Lung complications~     are the leading causes of morbidity and of death in sickle cell disease. Infections and~     increased inflammation play important roles in the development of the lung problems in sickle~     cell disease. Emerging evidence shows that vitamin D helps the immune system to fight~     infection and to control inflammation and could potentially help prevent respiratory~     complications in patients with sickle cell disease. The investigators hypothesize that oral~     vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents~     with sickle cell disease, will reduce the rate of respiratory events (infection, asthma~     exacerbation and acute chest syndrome) compared to the rate in a group given standard dose~     oral vitamin D3, 12,000 IU (0.3 mg) given once a month.~      Funding Source - U.S. Food & Drug Administration, Office of Orphan Products Development~   "
162130|NCT01443715|"~     It is challenging for depressed adolescents and their families to access specialized mental~     health services. A viable option is delivering treatment in the primary care clinic (PCC)~     setting; however, few effective models are currently available. The overall aim of this study~     is to assess in the pediatric PCC, the preliminary acceptability and feasibility of a novel~     collaborative stepped care model of treatment for depressed adolescents.~   "
162131|NCT01443702|"~     The investigators will investigate the safety and effectiveness of an Iranian traditional~     medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will~     be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in~     random order. End points are changes in urinary chemistries and stone burden by Ultra~     sonography / CT scan.~      It will be used in proven calcium stone forming adults who are not pregnant. This phase is a~     double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine~     supersaturations, pH and sodium determinations will be collected. Entry and final stone~     quantification Ultra sonography / CT scan will be performed. End points will be changes in~     urine chemistry/supersaturation and stone quantitative stone volume.~   "
162146|NCT01443507|"~     The purpose of the study is to compare exercise at 70% of maximal heart rate were total~     energy expenditure is twice compared to interval training at 90- 95% of maximal heart rate.~     Since 70% of maximal heart rate is well above the minimum threshold for improvements in~     maximal oxygen uptake it should be suited to investigate the effect of duration.~   "
162147|NCT01443494|"~     We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved~     sublingual microcirculation.~   "
162132|NCT01443689|"~     Burn trauma,especially extensive ones, remains a life-threatening local and general~     inflammatory condition destroying the skin and underlying tissues, and resulting in serious~     sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays~     an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and~     human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate~     the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic~     strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs~     transplantation will be evaluated in patients with acute burn.~   "
162133|NCT01443676|"~     The purpose of this study is to explore the efficacy of bevacizumab combined with~     radiotherapy compared with radiotherapy alone in the treatment of newly diagnosed~     glioblastoma in the elderly.~        -  Trial with medicinal product~   "
162134|NCT01443663|"~     H5N1 is an influenza virus that has the potential to cause an influenza pandemic. This study~     will evaluate the safety and immune response to an H5N1 influenza vaccine in people who have~     previously received one of two versions of an H5N1 vaccine or have previously received an~     H7N3 vaccine and in people who have not previously received any live attenuated influenza~     vaccine (LAIV).~   "
162135|NCT01443650|"~     Primary Objective:~      Injection Site Tolerability~      Secondary Objectives:~        -  To assess the safety profile of alirocumab SAR236553 (REGN727)~        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553~          (REGN727)~   "
162136|NCT01443637|"~     The CONFIRM study was developed to examine the prognostic value of cardiac computed~     tomographic angiography (CCTA) findings for prediction of future adverse cardiac events~     related to coronary artery disease (CAD) in a large, international patient population. The~     purpose of this multicenter registry is to correlate coronary and non-coronary cardiac~     findings by CCTA with demographic and clinical data for refinement of risk stratification of~     individuals with suspected or known CAD.~   "
162137|NCT01443624|"~     The purpose of this study is to evaluate the pro-oxidant toxicity of iron injections in~     critically ill patients and in healthy volunteers. The investigators hypothesize that the~     inflammatory state of critically ill patients will reduce the oxydative stress induced by~     iron injections, compared to the one induced in healthy volunteers. It will be an open~     proof-of-concept study aimed at evaluating iron toxicity in critically ill patients (n=40)~     as compared to healthy volunteers (n=40).~      The investigators will compare the oxidative stress (principal judgment criteria=~     8-iso-PGF2α) following a 100 mg injection of iron (at T0, T2, T6 and T24 hours post~     injection) in both groups and the investigators will compare the effect of repeated~     injections in the critically ill patients.~   "
162138|NCT01443611|"~     The actual recommendations for infants aged 3 to 12 months presented with first episode of~     Febrile Convulsions highly recommend performing lumbar puncture in order to rule out~     Bacterial Meningitis. On the other hand, recent studies in the era of anti Pneumococcal~     vaccination arise the question if in the presence of a normal physical examination those~     recommendations are still relevant. The purpose of this study is to summarized~     retrospectively the clinical records of all the infants admitted to the pediatric wards in~     the ten years period since 2000 to 2010 in order to record the incidence of Bacterial~     Meningitis among infants admitted with the First episode of Febrile Convulsions.~   "
162139|NCT01443598|"~     HYPID study is an observational and prospective study of patients with interstitial lung~     disease and pre capillary hypertension diagnosed by right heart sided catheterization. The~     primary aim of the study is to identify prognostic factors.~   "
162140|NCT01443585|"~     The purpose of the trial is to clinically evaluate the performance of a progressive addition~     lens among presbyopic patients.~      This evaluation will be done by performing visual tests and collecting subjective information~     from subjects wearing the lens which will be manufactured according to personal prescription.~   "
162141|NCT01443572|"~     Biliary atresia (BA) is a perinatal disease of unclear etiology, characterized by~     inflammation and obliteration of intrahepatic and extrahepatic bile ducts, leading to~     cholestasis and cirrhosis. Kasai operation remains as the first line operative treatment in~     BA. In the previous studies, inhalation anesthetics might induce liver damage. The choice of~     inhalation anesthetic that minimally affects hepatic function is important. Therefore, the~     purpose of this study is to compare the postoperative recovery and hepatic function between~     desflurane and sevoflurane, two most frequently used inhalational anesthetics in patients~     undergoing Kasai operation.~   "
162142|NCT01443559|"~     Acellular porcine cornea is a valid substitution for human cornea because of its similar~     biological structure, corneal superficial curvature and good histocompatibility toward human.~     Facing the lack of human cornea donor, it is hypothesised that using acellular lamellar~     porcine cornea as an alternative of lamellar human cornea to treat infectious corneal ulcer.~   "
162143|NCT01443546|"~     The project is a randomized, controlled, prospective study of oocyte donors comparing the~     safety and efficacy of triggering ovulation using a combination of two drugs—GnRH agonist and~     very low dose hCG—versus triggering ovulation with a standard hCG dose alone or a standard~     GnRH trigger alone.~   "
162144|NCT01443533|"~     This study is a randomized controlled trial that will evaluate the impact of a brief~     educational script on the method of birth control that women receive at their 6-week~     postpartum visit. The one-minute script (LARC script) is given to women in the hospital~     during their postpartum admission. It informs patients about long-acting reversible~     contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine~     device. The investigators hypothesize that women who are randomized to receive the LARC~     script will be more likely to report that they are using a LARC method, when queried~     immediately after their six-week postpartum visit.~   "
162145|NCT01443520|"~     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and~     neuropathic pain. After oral administration, tramadol is rapidly and almost completely~     absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed~     by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation~     is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral~     tramadol with duloxetine and venlafaxine. Duloxetine is known to inhibit CYP2D6. Twelve~     healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within~     ±15% of the ideal weight for height are taken into the study. Primary endpoints of the study~     are plasma concentrations of tramadol and its metabolites.~   "
162148|NCT01443481|"~     This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at~     single-dose and steady state in adult cancer patients either with mild, moderate or severe~     hepatic impairment or with normal hepatic function. Hepatic function in study patients will~     be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total~     bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and~     ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by~     RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any~     other reason.~   "
162149|NCT01443468|"~     Background:~      - Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types of~     cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain. It may~     also increase the risk for certain types of leukemia and other cancers. The only known cause~     of LFS is a change (called a mutation ) in a gene known as TP53. However, not all people with~     LFS have a TP53 mutation. Researchers want to study other possible genetic causes of LFS, and~     factors that may increase or decrease cancer risk in people with the syndrome.~      Objectives:~        -  To learn more about the types of cancers that occur in individuals with LFS.~        -  To study the role of the TP53 gene in the development of cancer.~        -  To look for other possible genes that cause LFS~        -  To study the effect of LFS diagnosis on families.~        -  To determine if environmental factors or other genes can change a person s cancer risk~          associated with LFS.~      Eligibility:~        -  Individuals with a family or personal medical history of cancers consistent with LFS.~        -  Individuals with a family or personal medical history of cancers that does not meet the~          diagnosis of LFS, but the history is suggestive for LFS (meets the diagnosis for the~          so-called Li-Fraumeni like syndrome)~        -  Individuals with certain rare cancers~        -  Individuals with a family or personal history of a TP53 gene mutation, with or without~          related cancer(s).~      Design:~        -  Participants will fill out a medical history questionnaire and a family history~          questionnaire.~        -  Blood samples will be collected for DNA and for storage. Cheek cell samples may be~          collected if blood cannot be obtained for DNA. Participants can choose to have or not~          have cancer screening with blood tests, imaging studies, and other exams.~        -  Participants will complete questionnaires about their worries about cancer, stress~          levels, and coping strategies. Diet and physical activity questionnaires will also be~          given. Other psychological tests may be given as needed.~        -  Participants will be monitored for several years, with regular followup visits to the~          National Institutes of Health, if indicated. Any changes in health or cancer status will~          be recorded.~   "
162150|NCT01443455|"~     This is a 6 month randomized clinical trial comparing video dance, brisk walking and delayed~     entry controls. The interventions have two phases; a 12 week initiation phase with~     substantial structure and supervision, followed by a 12 week transition phase, with reduced~     structure and supervision. Participants are 168 overweight or obese, sedentary postmenopausal~     women aged 50 to 65; 60 in each exercise arm and 48 in the wait list control group.~      The following research questions will be assessed:~        1. Is exercise adherence at 6 months better with video dance games compared to brisk~          walking?~        2. Does video dance game exercise compared to wait list controls, induce beneficial changes~          in physical and mental health?~        3. Does video dance game exercise compared to brisk walking better promote balance,~          attention and visual spatial skills, without loss of benefit to cardiovascular fitness?~        4. Is video dance preferred to brisk walking for exercise among postmenopausal women? If~          so, who and why?~   "
162151|NCT01443442|"~     Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically,~     patients manifest symptoms in the spring, summer and fall, when airborne allergens are at~     their peak. Patients may also be afflicted year-round, if sensitive to allergens such as dust~     mites or pet dander. Signs and symptoms of allergic conjunctivitis are conjunctival~     hyperemia, ocular itching, conjunctival and eyelid edema, papillary hypertrophy, tearing and~     burning.~      This is a randomized clinical study to evaluate the efficacy of Bepreve® (bepotastine~     besilate 1.5% ophthalmic solution) compared to Alrex® (loteprednol etabonate 0.2%) in the~     treatment of moderate to severe allergic conjunctivitis in patient over the age of 18 years.~     The study will be a two-week study with four visits. Ocular signs (eye redness( and symptoms~     (itching) will be monitored as outcome variables.~   "
162152|NCT01443429|"~     The PK and safety profiles to be examined following a single oral administration of~     TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to~     subjects with normal renal function.~   "
162153|NCT01443416|"~     This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination~     (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called~     Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein~     called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence~     that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used~     vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains~     only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two~     of the three additional serotypes included in PCV-13 which might be enough to protect~     children against disease caused by these two serotypes. Furthermore, previous studies have~     shown that PHiD-CV confers protection against a common otitis media pathogen in children~     called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D,~     which is derived from NTHi. In addition, the use of a carrier protein, which is not closely~     related to an antigen included in any coadministered or previously administered routine~     vaccine minimises the risk of interference related to it.~      The investigators aim to recruit 168 healthy children at the age of 12 months who have~     already received two doses of PCV-13 according to the UK routine immunisation schedule at 2~     and 4 months of age. Participants will then be randomised to receive a booster dose of either~     PCV-13 or PHiD-CV at 12 months of age.~      Three visits will take place at their parents' home and will involve a blood test followed by~     a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month~     after visit 1) and 3 (1 year after visit 1).~   "
162154|NCT01443403|"~     The purpose of this study is to determine efficacy and safety of naldemedine for the~     treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving~     opioid therapy for ≥ 3 months.~   "
162155|NCT01443390|"~     When a patient with advanced cancer consults with a member of the Phase I drug development~     team, the investigators utilize all information possible to try to select a therapy for that~     patient which has the best chance of working for them. This information includes:~        1. Past published information~        2. Clinical experience and judgement~        3. Immunohistochemistry for specific targets (e.g., ER)~        4. Standard sequencing (e.g., for K-Ras) and other methods now available.~      The investigators have a new tool which warrants early exploration for what role it might~     eventually play in the process of selecting the best therapy for an individual patient. The~     basis of the current ancillary exploratory study is to gain initial experience with the~     operational aspects of this whole genome sequencing in this setting.~   "
162156|NCT01443377|"~     This study aims to investigate the combination of panitumumab and a 5-FU-based RCTX in~     patients with locally advanced KRAS wild-type rectal cancer.~   "
162158|NCT01443351|"~     Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with~     refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for~     long-term effects of these drugs. In this observational study, effects and adverse effects~     including evaluation of bone marrow biopsies done at fixed intervals will be recorded from~     ITP patients treated with TPO-ra. For some patients, blood samples will be collected for~     research use.~   "
162159|NCT01443338|"~     The purpose of this study is to determine whether Triptergium wilfordii, and Acitretin are~     effective and safe in the treatment of patient of moderate to severe psoriasis vulgaris.~   "
162160|NCT01443325|"~     In the present placebo-controlled cross-over study the researchers intend to investigate~     analgesic and sensory effects of a lidocaine patch in patients with severe persistent~     inguinal post-herniorrhaphy pain.~   "
162161|NCT01443312|"~     The definition of Thalassemia Intermedia is not generally accepted and the specific clinical~     and laboratory characteristics varies between patients. Some patients are blood transfusion~     dependent and others are occasionally transfused. Also the mutations in the beta globin gene~     are diverse. Another mutations including mutations in the alfa globin gene and in the xmn1~     gene can affect the clinical course of this disease. The purpose of this study is to~     summarize the characteristics of patients with Thalassemia Intermedia treated at the~     Pediatric Hematology Unit at the HaEmek Medical Center in Israel~   "
162162|NCT01443273|"~     There are several factor that can be related to Neonatal Thrombotic events. Among them~     hypercoagulability can be the cause of those events. Factor V Leiden (FVL) and Prothrombin~     mutation are the most common causes of hereditary thrombophilia. The incidence of in the arab~     population is known to be higher than the incidence in another western populations. The~     purpose of this study is to review retrospectively the thrombophilic risk factors that were~     found in a cohort of premature babies and term newborns treated and investigated at the~     Neonatal Intensive Care Unit and at the Pediatric Hematology Unit.~   "
162163|NCT01443260|"~     The purpose of this study is to determine whether GL-ONC1, an attenuated vaccinia virus, is~     safe when administered to patients with peritoneal carcinomatosis via an infusion within the~     abdominal cavity through an implanted catheter. The study seeks also to arrive at a~     recommended dose and schedule for future investigations, evidence of anti-tumor activity,~     detection of virus in body fluids, analysis of viral delivery to tumor and normal cells, and~     to evaluate if there is an antibody response to vaccinia virus.~   "
162164|NCT01443247|"~     The purpose of this study is evaluate the role of anti-d in dengue fever.~   "
162165|NCT01443234|"~     This research study is designed to investigate the effects of an online computer program,~     called OxIGen (Oxford Imagery Generation), on thinking style and mood in depression. The~     OxIGen program will be delivered online over four weeks and with follow-up at one, three and~     six months. This will inform potential future development of this computerized task into an~     online intervention to modify negative thinking styles in depression.~   "
162166|NCT01443221|"~     To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose~     combination of mitiglinide/metformin, compared with free combination of mitiglinide and~     metformin in healthy male subjects.~   "
162167|NCT01443208|"~     To evaluate the pharmacokinetics and safety of single dose and multiple doses of~     desvenlafaxine in Korean healthy subjects and compare to westerners.~   "
162168|NCT01443195|"~     Iron is an essential micronutrient that plays an important role in cellular functions of all~     microorganisms. Both iron deficiency and iron excess during the early weeks of life can have~     severe effects on neurodevelopment that may persist into adulthood and may not be corrected~     by restoration of normal iron levels.~      Iron overload remains a significant concern in preterm infants because they have low levels~     of iron-binding proteins and immature antioxidant systems.~      The aim of the study is to evaluate if iron supplementation is required/necessary in VLBW~     Very Low Birth Weight (less than 1500 grams) and to assess the efficacy and safety of the~     iron supplementation practice for VLBW preterm infants as implemented in the Neonatal~     Intensive Care Unit (NICU) at the Ha'Emek Medical Center, Afula, Israel.~   "
162169|NCT01443182|"~     Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural~     therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress~     disorder (PTSD) following single-event traumas and to be more effective than pure anxiety~     management or stabilization treatments. However, much less is known about the efficacy of the~     different treatment approaches in survivors of repeated or chronic interpersonal trauma.~     Recent evidence suggests that a combination of stabilization treatment + TF-CBT is~     efficacious in this population. Although EMDR is also often used in survivors of chronic~     interpersonal trauma, evidence on its efficacy are still poor. The aim of the current study~     is to compare the efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a~     randomized controlled trial in a routine clinical setting.~   "
162170|NCT01443169|"~     This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence~     cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a~     330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro~     dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg~     market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th~     period to to estimate and compare the % of dose absorbed versus time profile for the three CR~     prototype tablets and the CR reference tablet.~   "
162171|NCT01443156|"~     BACKGROUND. Sleep deficiency (not getting enough sleep) is widespread in American adults and~     can lead to many harmful health outcomes such as a higher risk of obesity, heart disease, and~     diabetes. Sleep deficiency can also harm cognitive performance, which refers to one's~     awareness and thinking ability. Sleep deficiency and sleep-related health issues are of high~     interest among those who have irregular and/or extended work schedules, because such~     schedules can interfere with normal biological rhythms of sleepiness and wakefulness.~      PURPOSE. This study will examine the health and cognitive effects of work schedule and sleep~     patterns in caregivers (such as nurses, laboratory technicians, and non-clinical hospital~     staff). The investigators hypothesize that the nontraditional, irregular, and extended work~     hours common in these professions will have adverse health and cognitive effects. The~     purposes of this protocol are to:~        -  Enroll caregivers into a one year cohort study on the relationships among work schedule,~          sleep, diet, chronic disease, and cognitive performance. (A cohort study follows a group~          of participants over time to see how different behaviors or risk factors affect health.)~        -  Collect data from caregivers on work schedule, sleep, diet, chronic disease, and~          cognitive performance.~        -  Give personalized information and feedback to caregivers about these health factors.~        -  Educate caregivers about healthy diet and exercise choices.~        -  Collect saliva from caregivers for future research on the role of genes in health.~          (Specimen collection for genetic testing will be offered as a separate option for study~          participants.) RECRUITMENT. This study will use the Let's Get Healthy! health research~          and education program (OHSU IRB #3694) as a platform for recruitment and data~          collection. Caregivers will be invited to participate in a Let's Get Healthy! event and~          will be given information prior to the event about the cohort study. At the Let's Get~          Healthy! event, caregivers will first consent to the anonymous research study (OHSU IRB~          #3694), in which demographic and health screening data are linked to a random number.~          Caregivers will then have the option to consent to a cohort study, in which data are no~          longer anonymous but instead linked to participants' names and contact information.~      PROCEDURES. This cohort study piggybacks on procedures already approved for the Let's Get~     Healthy! program (OHSU IRB #3694). Let's Get Healthy! is a study in which participants~     provide anonymous data at health fairs through any or all of the following manners: short~     computer surveys on cancer awareness, risk factors, and family history (with immediate~     feedback given on cancer risk and prevention); short computer surveys on diet and sleep~     patterns (with immediate printed feedback given); health screening measurements (blood~     pressure, height, weight, waist circumference, body mass index, body fat percentage); a~     finger stick to assess sugar and fat levels in blood; and a mouthwash swish to provide a~     saliva specimen.~      However, this cohort study (OHSU IRB #7542) will make the following changes and additions:~        -  Personal health data, instead of being anonymous, will be linked to participants' names~          and contact information (for follow-up data collection).~        -  Let's Get Healthy! events will include cognitive performance tests, a preventative-care~          survey, and a work schedule survey.~        -  Participants will provide data not only at an initial Let's Get Healthy! event, but also~          at a follow-up event and during the time period between events. Between events,~          participants will do the surveys on work schedule, diet, and sleep, and they will~          complete cognitive performance tests.~        -  There will be a separate consent process for participants to provide a fully~          identifiable saliva specimen.~      DATA ANALYSIS. Participants' health data will be fully identifiable at the time of data~     collection but will be coded and stored in a physically separate location from the~     identifiable information. The link between identifiable information and coded health~     information will be stored on a password protected computer, and all identifiable information~     will be deleted upon completion of data analyses. Data will be analyzed to explore~     relationships among work schedule, sleep, diet, body composition, metabolic health, chronic~     disease, and cognitive performance in caregivers. Genetic relationships with these factors~     will be analyzed in those who provided a saliva specimen during entry visit data collection.~   "
162172|NCT01443143|"~     This investigation will examine the effects of consuming a structured, portion-controlled,~     low-glycemic index diet (commercially available as the Nutrisystem-D program) on several~     indicators of glycemic stability and variability among participants with type 2 diabetes.~     Results on the portion-controlled diet will be compared with those on participants' usual~     diets in a randomized cross-over trial. The investigators expect that participants will~     exhibit greater glycemic stability (e.g., more time in euglycemic range) and less glycemic~     variability (e.g., smaller mean amplitude of glycemic excursions) while consuming the~     Nutrisystem D program, as compared with their usual diet.~   "
162423|NCT01439854|"~     The purpose of this study is to examine the effect of the chronic treatment of type 2~     diabetes (T2DM) with dapagliflozin on: (1) mitochondrial gene function/expression and insulin~     signaling/action and (2) oral glucose tolerance and beta cell function. Dapagliflozin is a~     potent, highly specific inhibitor of renal glucose transport [SGLT2].~   "
162173|NCT01443130|"~     The purpose of this study is to test prevention strategies for pregnancy-related malaria.~     Researchers will compare different malaria treatments and treatment schedules which include~     chloroquine therapy (weekly doses versus being dosed twice during pregnancy for 3 days each~     time) to the standard practice of preventive treatment intervals in pregnancy (with the drug~     sulfadoxine-pyrimethamine given twice during pregnancy). Participants will include 900~     pregnant women, who will be assigned to one of three treatment groups. Blood samples will be~     collected at every visit before birth and any time the participant is ill to determine if~     malaria is present. Pregnant women will be monitored during pregnancy and newborns will be~     assessed at birth and followed until about 14 weeks. Participant involvement in the study is~     expected to last about 12 months.~   "
162174|NCT01443117|"~     HIV-infected people and pregnant women are at risk of developing severe pneumococcal disease.~     The purpose of this study is to compare the safety and immune response to two pneumococcal~     vaccines in HIV-infected pregnant women.~   "
162175|NCT01443104|"~     Coronary artery stents have improved the safety and efficacy of percutaneous coronary~     intervention for coronary artery disease. Drug-eluting stents have been shown to decrease~     neointimal hyperplasia and to reduce the rate of restenosis and target-lesion~     revascularization as compared to bare-metal stents. Drug-eluting stents consist of a metallic~     platform and a therapeutic substance that is usually released from a polymer matrix. A~     previous study utilizing a bioresorbable polymer has demonstrated a favorable safety and~     efficacy profile in a large-scale clinical trial as compared to a first-generation~     druf-eluting stent (LEADERS trial).~      The objective of the study is to compare the safety and efficacy of a sirolimus-eluting stent~     with a biodegradable polymer with an everolimus-eluting stent with a durable polymer in a~     prospective multicenter randomized controlled non-inferiority trial in patients undergoing~     percutaneous coronary intervention in routine clinical practice.~   "
162176|NCT01443091|"~     Colostrum, mothers' early breastmilk, contains multiple factors that provide immune~     protection to very low birth weight (VLBW) infants, a population at high risk for~     hospital-acquired infections. However, critical illness during the first few days of life~     often prevents the initiation of enteral feeds, placing these infants at even higher risk for~     morbidities including feeding intolerance and infection. Oropharyngeal administration has~     been proposed as an alternative route of delivery for colostrum and the immune benefits it~     provides. Research from animal and adult human models supports oropharyngeal administration~     as a potentially safe and effective mode of delivery for immune therapies. Immune components~     of colostrum, such as secretory IgA, may have both direct and indirect effects on the immune~     system. The purpose of this proposed randomized, placebo-controlled pilot study is to~     determine the effect of oropharyngeally administered colostrum (OAC) on immune stimulation in~     VLBW infants, as measured by secretory IgA (sIgA) levels. In addition to measuring sIgA~     response to OAC the investigators will also collect clinical data to determine if OAC has~     effects on tolerance of enteral feedings and rates of infection. The investigators~     hypothesize OAC will have a moderate effect on salivary secretory IgA concentration in VLBW~     infants. If proven efficacious, utilization of OAC in VLBW infants could have far reaching~     consequences for these highly fragile babies including lower rates of infection, improved~     tolerance of enteral feedings, and shorter NICU stays.~   "
162177|NCT01443078|"~     The purpose of this study is to test a new approach to the use of standard drugs before~     surgery in patients with lung cancer. This study will find out what effects, good and/or bad,~     that this approach has on the cancer.~      It is routine to give chemotherapy prior to surgery in patients with this type of lung~     cancer, to help keep it from coming back. It is also routine to perform a special type of~     scan called a PET scan. This PET scan measures how active a cancer is by use of a special~     tracer made out of sugar. In this study, all patients will have a PET scan and then be~     treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a~     non-squamous cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In~     rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most~     patients, a repeat PET scan will show that the tumor is decreasing and they will complete~     standard chemotherapy then go on to have surgery.~      In some patients, a repeat PET scan will show that the tumor has not decreased enough. For~     these patients, the routine practice is to proceed with surgery. This research study will~     test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine~     and cisplatin to a different treatment called vinorelbine and docetaxel is safe and~     effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a~     different way than pemetrexed or gemcitabine and cisplatin.~   "
162178|NCT01443065|"~     This multicentre, open-label, randomized phase II trial is ongoing in 30 centres in France.~     Main eligibility criteria include: histologically proven adenocarcinoma of the stomach,~     esophagus or gastroesophageal junction; locally advanced or metastatic disease; measurable~     disease (RECIST 1.1); no known HER2 overexpression; no prior palliative chemotherapy.~   "
162179|NCT01443052|"~     A large proportion of falls in older people occurs when walking. Most studies have recently~     demonstrated correlation between the variations in spatiotemporal gait parameters and fall~     risk in elderly and in several diseases. The investigators objective is to analyse this~     parameters in population with gait stability disorders (post-stroke patients and fallers) to~     identify the most valuable and to develop/test a conglomerate stability score.~   "
162180|NCT01443039|"~     The activity of drug-metabolizing enzymes and transporters evolutes after Roux-en-Y gastric~     Bypass.~      Primary aim : To study the intra individual evolution of phenotypical markers of different~     drug metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and~     P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.~   "
162181|NCT01443026|"~     The purpose of this research study is to compare the effects of a lycopene supplement made~     from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal~     cells in the prostate, but have not yet had cancer detected. This study will allow us to see~     if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and~     in chemicals measured in the blood that go along with a higher risk of developing cancer.~   "
162458|NCT01439399|"~     The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine~     and ketamine in the perioperative period of abdominal surgery.~   "
162182|NCT01443013|"~     This observational study is designed to analyse the urinary mRNA expression of Foxp3 and~     Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant~     recipients from 17 renal transplant site in France and to determine the predictive value of~     these gene expression on the one year graft outcome including graft function, one-year graft~     histological analysis and incidence of acute rejection.~   "
162183|NCT01443000|"~     The purpose of this study is to characterise the clinical features, histopathology and the~     treatment outcomes of patients with idiopathic orbital inflammation syndrome.~   "
162184|NCT01442987|"~     The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and~     Atorvastatin in patients with hypertension and hyperlipidemia.~   "
162185|NCT01442974|"~     Targeting tumor stroma is emerging as a strategic approach for pancreatic cancer treatment.~     Actually, one of the most interesting characteristics of pancreatic cancer is the dense~     fibrotic stroma surrounding tumor cells. Moreover, pancreatic cancer stroma seems to express~     a specific protein profile different from tumor cells. For example, secreted protein rich in~     cysteine (SPARC) is overexpressed in pancreatic tumor stroma fibroblast and downregulated in~     tumor cells. This characteristic is associated with poor clinical outcome.~      Nab-paclitaxel, an albumin bound nano formulation of paclitaxel that targets SPARC, decreases~     tumor stroma density. Such effect improves drug delivery, and enhances both, nab-paclitaxel~     and gemcitabine, antitumor activity in nude mouse models.~      Based on this pre-clinical data the investigators designed a clinical trial of nab-paclitaxel~     in combination with gemcitabine as neo-adjuvant treatment for pancreatic cancer patients.~     Fifteen, SPARC positive patients, will be enrolled in the study and treated with abraxane in~     combination with gemcitabine.~      This is a pilot study which primary end point is evaluating the effect of Abraxane in~     combination with gemcitabine on tumor stroma, and the secondary end-point is correlating~     these changing with treatment activity.~   "
162186|NCT01442961|"~     The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is~     faster than after abdominal approach. The aim of this study is to evaluate postoperative pain~     after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid~     consumption.~   "
162187|NCT01442948|"~     Monocytes may be separated into phenotypically and functionally distinct cell types by the~     presence or absence of the lipopolysaccharide receptor CD14 and the Fcγ-receptor CD16. The~     investigators hypothesize that the total numbers of CD16+ monocytes are significantly related~     to cardiovascular outcome in patients with angiographically proven coronary heart disease.~   "
162188|NCT01442935|"~     The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the~     experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi~     chemotherapy plus targeted therapy); in both arms the targeted therapy is selected according~     to K-Ras status of the patient's tumor.~      The secondary objectives are to evaluate the objective response rate (CR and PR) after 4~     cycles of treatment, according the RECIST V1.1 evaluation scale.~        -  the rate of complete remission (CR) at 6 months after the last study treatment (hepatic~          surgery or last chemotherapy cycle).~        -  the specific rates of resection R0, R1, R2.~        -  the complete pathological response Rate,~        -  the relapse-free survival rate in (R0 or R1) resected patients,~        -  the response duration in non-resected patients,~        -  the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be~          evaluated with the Levi scale,~        -  the post operative complications using the DINDO classification,~        -  the progression-free survival (PFS) and overall survival (OS).~      The objectives of the biological study are:~        -  to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF,~          TP53) and genetic amplification related factors (EGFR),~        -  to evaluate patient-related predictive factors in connection with genetic polymorphisms~          (Fc gamma and VEGF receptors),~        -  to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free~          and progression-free survival,~        -  to study circulating of tumor cells as prognostic factor for metastatic colorectal~          cancer, non- resectable at presentation.~   "
162189|NCT01442922|"~     The primary purpose of the study is to establish the degree and duration of pain relief~     following minimally invasive surgery for a painful degenerative disc.~   "
162190|NCT01442909|"~     Both pemetrexed and docetaxel have been reported to have similar activity against non-small~     cell lung cancer (NSCLC) who failed previous chemotherapy in a large randomized phase III~     study. However, no study showed different toxicity and efficacy profiles within individual~     patients. Present phase II randomized clinical trial is designed to answer these questions,~     with addition of information about whether or not sequential therapy can prolong disease-free~     and overall survival.~   "
162191|NCT01442896|"~     The purpose of this study is to perform exploratory analyses to evaluate rates of functional~     and structural change in glaucoma, to identify predictors of rapid progression in patients~     with glaucoma and to identify possible genetic factors and biomarkers associated with the~     disease.~   "
162192|NCT01442883|"~     In patients with treatment resistent hypertension renal nerve ablation emerged as an~     effective interventional approach of treating hypertensive disease with a progressively~     increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is~     one of the major underlying pathogenetic mechanism of the fall in blood pressure but the~     precise mechanisms that causes the fall in blood pressure in the short-term and, in~     particular, long-term remains elusive. The objective of the study is to understand the~     pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic~     nervous system. In 100 hypertensive patients most advanced technology will be applied, before~     and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic~     activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labelling~     technique), local activity of the renin angiotensin system in the kidney (urinary~     angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI~     technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large~     arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24~     hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall~     in blood pressure after renal denervation may help to identify those hypertensive patients~     that profit most from renal nerve ablation in terms of blood pressure reduction.~      The investigators propose the following hypotheses why a progressive decrease in blood~     pressure happens, in addition to the decreased activity of the central nervous system, after~     renal nerve ablation:~      Short term effects:~      A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the~     kidney C)Exaggerated sodium excretion immediately after renal nerve ablation~      Long term effects:~      D)Decrease of total sodium content after 6 and 12 months. E)Improvement of vascular wall~     properties after 6 and 12 months~   "
162226|NCT01442441|"~     In this research project the investigators intend to find out if Endoscopic Ultrasound (EUS)~     criteria for diagnosing chronic pancreatitis can be correlated with pathologic~     characteristics of tissues taken from pancreas of patients with suspected chronic~     pancreatitis.~      This will be a retrospective study which will examine results from biopsy specimens and~     endoscopic ultrasound findings in suspected chronic pancreatitis.~   "
162193|NCT01442870|"~     Metformin is a drug that is normally used to treat people with diabetes. New research has~     discovered that metformin may also kill cancer stem cells. These cancer stem cells make up~     only a small portion of a cancer, but may be responsible for resistance to chemotherapy or~     for causing recurrence of the cancer. Future studies are envisioned to that test the efficacy~     of administering metformin with chemotherapy. The purpose of this study is to assess the~     safety of administering metformin in combination with chemotherapy. Since chemotherapy and~     cancer itself both cause adverse events by themselves, this study is designed to have a~     run-in stage as well as a subsequent randomization to metformin or no metformin. The primary~     endpoint will compare the rate of dose-limiting toxicities between these two arms. After a~     period of 3 weeks for the primary endpoint comparison, all patients will receive metformin.~   "
162194|NCT01442857|"~     The axillary region is regularly used for brachial plexus block. The technique may be guided~     by nerve stimulation, ultrasound or a combination of nerve stimulation and ultrasound.~     Magnetic resonance imaging (MRI) has been beneficial in presenting anatomy of interest for~     regional anesthesia and in demonstrating spread of local anesthetic (LA). An axillary~     MRI-study at our department supported the suggestion of multiple rather than a single~     injection technique. Using a 0.5 Tesla open MR scanner in that study, the investigators were~     not able to distinguish terminal nerves from equally sized vessels. Therefore the~     investigators could not definitely answer whether the LA reached the pertinent nerves. The~     investigators have recently performed an axillary block study with a 3.0 Tesla scanner. Now~     the terminal nerves were identified and for each patient the investigators could observe if~     the LA reached the nerves.~      The aim of this study was to demonstrate the anatomy of the brachial plexus in the axillary~     region at different levels. The investigators present the best pictures of the nerves with~     and without LA injected. The images are demonstrated in the axial and coronal plane.~   "
162195|NCT01442844|"~     This study evaluates a novel micrografting technique to see how it will influence the healing~     rate and cosmetic result of second intention wounds. The graft harvesting and micrografting~     process was designed by MoMelan Technologies The Epidermal Expansion System, which is~     composed of a commercially available Blister Generation Device and the Microblister~     Generation and Excision Device (MBGED), will generate an array of small microblisters and~     transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing)~     for application to the subject's surgical area. The investigators predict that applying~     expanded micrografts to wounds that otherwise would have healed by second intention alone~     will hasten healing and possible reduce scarring.~   "
162196|NCT01442831|"~     The purpose of this study is to describe the single dose pharmacokinetics of total~     radioactivity in plasma and whole blood following PO administration of [14C] TR-701 in~     healthy adult male subjects.~   "
162197|NCT01442818|"~     The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain~     relief and patient satisfaction when compared to scheduled intravenous analgesia following~     vaginal reconstructive surgery.~   "
162198|NCT01442805|"~     The project aims to explore the potential of Virtual Reality Exposure Therapy (VRET) for the~     treatment of the fear of driving, the fear of flying and the fear of public speaking.~      The study is a randomized controlled trial (RCT) designed to compare the efficiency of~     cognitive behavioural therapy with exposures in imagination to behavioural therapy with~     exposures in virtual reality. Anxiety levels are measured using specific questionnaires, SUD~     ratings and physiological measures (heart rate, skin conductance, skin temperature, breathing~     frequency, heart rate variability).~      Hypothesis: Treatments with exposures in virtual reality are more efficient than treatments~     with exposures in imagination.~   "
162199|NCT01442792|"~     Balloon angioplasty (Percutaneous Coronary Intervention (PCI)) is commonly used to treat~     patients with obstructive coronary artery disease (CAD). Although PCI is highly effective for~     the management of CAD, it can potentiate an existing prothrombotic state around lesion areas.~     A certain level of anticoagulation is required to perform planned PCI safely and to minimize~     the periprocedural risk of thrombosis and its attendant complications, including myocardial~     ischemia and infarction (heart attack). Many different anti-thrombotic regimens have been~     investigated and are currently in use. The aim of this study is to explore whether~     Rivaroxaban, as compared to unfractionated heparin, on the background of standard dual~     antiplatelet therapy, can effectively suppress thrombosis and related adverse ischemic~     events, upon balloon inflation and stent expansion, during elective PCI, without increasing~     bleeding. The treatment assignment will be done in a semi-blinded design, eg, no blinding for~     randomization either to Rivaroxaban (one of the three arms) or the control (UFH) group.~     However, all will be blinded for the treatment dose of rivaroxaban (either 10mg or 20 mg).The~     10 mg rivaroxaban plus 50 IU UFH arm will not be blinded.~   "
162200|NCT01442779|"~     The purpose of this study is to determine the possible efficacy of low dose, orally~     administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).~   "
162201|NCT01442766|"~     Stroke is a major personal and social burden, being the commonest cause of severe adult~     disability. Recovery has been shown in animal models to be dependent upon adequate levels of~     acetylcholine within the brain - which in stroke is likely to be deficient. This is because~     acetylcholine-producing nerve cells in the brain are often damaged by strokes. Consequently,~     the investigators hypothesise that recovery may be improved by boosting acetylcholine levels~     in the brain - that can be readily achieved by treating with donepezil.~      AIMS: To establish: 1) whether motor deficits in acute stroke improve more in patients taking~     donepezil, relative to placebo, for 12 weeks; 2) whether brain functional MRI changes as a~     result of donepezil after 12 weeks.~   "
162202|NCT01442753|"~     The goal of this project is to evaluate the effectiveness of a family-based tobacco use~     prevention intervention directed at immigrant Latino parents of middle school aged youth as~     delivered in partnership with seven community organizations. The primary outcomes of the~     study are youth susceptibility to tobacco use, and changes in parenting practices among the~     parents of the youth. The planning, initiation, and delivery of the intervention will occur~     in collaboration with community organizations that have identified this project as important~     to the families they serve. Though the collaboratively designed training curriculum has been~     successfully tested and a study design for the current project established, a substantive~     development period for this project will allow the research team and collaborating~     organizations to consider key aspects of design and delivery.~   "
162203|NCT01442740|"~     Functional Endoscopic Sinus Surgery (FESS) is normally performed in our centre in a 0-degree~     supine position, with the patient laying flat. This study will be investigating whether~     changing patients to a 15-degree head up, feet down position will improve field of view and~     reduce blood loss during surgery. The 15-degree head up, feet down position has been used in~     other circumstances, such as brain surgery and for severely obese patients where airways can~     be blocked due to lying flat. Every 15 minutes, blood pressure, heart rate and field of view~     according to the Boezaart nasal scope scaling system will be recorded.~   "
162204|NCT01442727|"~     Context: Approximately 100 million people throughout the world consume water contaminated~     with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh~     alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected~     regions. There are no proven therapies for treating chronic arsenic toxicity or for~     preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a~     variety of animal models. The investigators have recently shown in animals and humans that~     this effect is mediated by the formation of [(GS)2AsSe]- , the seleno-bis(S-glutathionyl)~     arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two~     Phase II studies in China and Bangladesh have suggested clinical benefit to selenium~     supplementation in arsenicosis patients.~      Objective: To assess whether daily selenium supplementation counters arsenic toxicity in~     patients exposed to drinking water arsenic. If proven effective, selenium supplementation~     might be safely and cost-effectively implemented in the worst-affected localities.~   "
162205|NCT01442714|"~     The purpose of the trial is to study how the elderly patients who have previously undergone~     treatment for acute myeloid leukemia and high-rRisk myelodysplastic syndromes, respond to a~     combined treatment with azacitidine and lenalidomide.~   "
162206|NCT01442701|"~     The investigators intend to investigate whether the rise in childhood obesity is caused by~     the loss of recurrent and chronic infections in modern, industrialized society, beginning in~     utero and extending through early childhood. The investigators will also examine whether the~     antimicrobial triclosan, present in numerous cleaning and hygiene products, decreases the~     incidence of infection within a household.~   "
162207|NCT01442688|"~     This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin~     administered alone & in combination with MMX Mesalazine/mesalamine.~   "
162208|NCT01442675|"~     The purpose of this trial is to describe the safety and antibody response to revaccination~     with Menactra vaccine in persons who received their first dose at ≥11 years of age.~      Primary Objective:~      - To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured~     by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in~     subjects who were first vaccinated with Menactra 4-6 years ago.~      Secondary Objective:~      - To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens~     collected 6 days post-vaccination in a subset of study population.~      Observational Objective:~      - To describe the rates of immediate reactions, solicited injection-site and systemic~     reactions, unsolicited adverse events and serious adverse events following vaccination.~   "
162209|NCT01442662|"~     The aim of this research is to study the activity of pazopanib in second line after~     anthracyclines in extra uterus and uterine LMS in association with gemcitabine.~   "
162210|NCT01442649|"~     The main objective is to evaluate progression-free survival (PFS) at 4 months.~      The secondary objectives are to evaluate the objective response rate (OR) (= complete~     responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the~     progression-free survival (PFS), the overall survival (OS), the overall survival from the~     date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance~     (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the~     quality of life according to the EORTC QLQ-C30 criteria.~      The objectives of the biological study are to evaluate potentially predictive anti-EGFR and~     anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of~     bevacizumab associated with chemotherapy in mCRC treatment.~   "
162211|NCT01442636|"~     The objective of this clinical evaluation is to evaluate the immediate and long term (up to~     12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott~     Vascular) in a controlled prospective investigation for the treatment of patients with~     critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the~     level of the below the knee arteries. Specifically the trial aims to illicit angiographic and~     ultrasound patency, clinical improvement, and adverse events associated with the use of this~     stent. The trial design is single armed, prospective, controlled trial run over 12 months of~     follow-up.~   "
162212|NCT01442623|"~     Dizziness is a common and disabling symptom and is associated with unsteadiness in both~     standing and walking, sometimes resulting in falls. People who have any of these problems~     often have a disease process affecting the inner ear. A proportion of people will recover~     spontaneously over time; those that do not may benefit from a specialized form of~     physiotherapy known as vestibular rehabilitation. This consists of exercise regimes that are~     individualized to each person depending on their problems. These regimes aim to decrease~     dizziness, help patients to re-learn movement patterns and improve their balance during~     standing and walking. There is considerable research supporting vestibular rehabilitation but~     it is not clear what is the best type, setting or frequency of treatment. How therapy impacts~     on walking ability is also not clear. Recent developments have suggested that force plate and~     virtual reality therapies may benefit. This form of therapy can provide feedback that is~     unavailable with conventional exercises. Exposure to virtual environments can challenge~     balance which helps to retrain it. The aim of this study is to compare conventional~     vestibular rehabilitation with a force plate/virtual reality therapy based vestibular~     rehabilitation, using a universally available virtual reality system (Nintendo Wii Fit~     Plus®). In this study, consenting patients with a vestibular disorder will be assigned~     randomly to either a conventional treatment or a virtual reality based treatment that is~     customized to their individual problems. They will receive treatment for 8 weeks. The effects~     of treatment will be measured by state of the art computerized analysis of walking and~     balance. Questionnaires that obtain information about how severe their dizziness is will also~     be administered. The study will help therapists understand how inner ear problems affect~     walking and balance. It will also provide information on the optimum method of providing~     vestibular rehabilitation and thus improve patient care.~   "
162213|NCT01442610|"~     As the MAO-B inhibitor rasagiline is able to improve motor skills it might have positive~     effects on sleep disruption by reducing nocturnal akinesia. As it was reported to cause only~     minor sleep disruption in PD Patients, it might be able to improve sleep architecture. The~     investigators thus study the effects of Rasagiline on sleep disturbances measured by~     polysomnographic (PSG) evaluation of sleep efficacy and PDSS-2. Secondary measures are other~     sleep variables measured by PSG, sleep quality and daytime sleepiness assessed by~     standardized scales as well as cognitive function, depression and QoL index.~   "
162214|NCT01442597|"~     The investigators are conducting a randomized clinical trial of our new web-based version of~     the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling~     at SATU. The computer-based training program (CBT4CBT) focuses on teaching basic coping~     skills, presenting examples of effective use of coping skills in a number of realistic~     situations in video form, and providing opportunities for patients to practice and review new~     skills while receiving substance abuse treatment.~   "
162215|NCT01442584|"~     Ovarian transplantation has been shown to restore fertility.~   "
162216|NCT01442571|"~     The proposed research is to examine the effect of injecting a large volume of HA (10cc) at~     the time of post arthroscopy suture removal (9-11 day post surgery), in patients with~     cartilage damage of ICRS grade 2 and above in one of the knee compartments.~   "
162217|NCT01442558|"~     The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial~     plexus blocks for surgical anesthesia~   "
162218|NCT01442545|"~     The purpose of this study is to evaluate the effects of JNJ-39758979 on the pharmacokinetics~     (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.~   "
162219|NCT01442532|"~     The purpose of Part 1 of this study is to evaluate the safety, tolerability, and~     pharmacokinetics (PK, how the drug is absorbed in the body, distributed within the body,~     and how it is removed from the body over time) of JNJ-38518168 in comparison with placebo~     following single dose and 14 days of consecutive dosing in healthy Japanese and Caucasian~     adult male participants. Part 2 of this study will evaluate the effect of JNJ-38518168 on the~     pharmacokinetics of midazolam in healthy participants.~   "
162220|NCT01442519|"~     Intravesical treatment for superficial bladder cancer has been used for the past 4-5 decades.~     Intravesical chemotherapy is beneficial in terms of recurrence and time to recurrence in~     grade 1-2 stage Ta tumours, usually non-invasive. Intravesical chemotherapy has negligible~     effect on disease progression in high-risk superficial bladder cancer—ie, grade 3, stage T1,~     and carcinoma in situ. However, BCG as induction and maintenance treatment effectively delays~     progression. Electromotive mitomycin increases tissue uptake compared with that of passive~     diffusion. Electromotive mitomycin has emerged as an alternative or complementary treatment~     to BCG. The rationale for combining anticancer drugs is based on the need to increase~     efficacy and reduce emergence of resistant malignant cells. This approach is not frequently~     applied to use of intravesical agents for treatment of superficial bladder cancer, for which~     immunotherapeutic BCG and chemotherapeutic mitomycin seem to be a potentially effective~     combination. Studies have addressed concurrent use of mitomycin and BCG, and assigned two~     roles to mitomycin: antitumor action and tissue-scarifying (ie, surface-modifying) effect~     that enables BCG to attach more efficiently to the urothelium. The investigators therefore~     aimed to assess whether induction of inflammation by use of BCG before mitomycin treatment~     makes the bladder mucosa more permeable and thus enables mitomycin to reach the target more~     easily. This randomised trial to compare the efficacy of sequential BCG and electromotive~     mitomycin with that of the current standard of BCG alone for patients with high-risk~     superficial bladder cancer.~      After transurethral resection and multiple biopsies patients with stage pT1 bladder cancer~     are randomly assigned to: 81 mg BCG infused over 120 min once a week for 6 weeks; or to 81 mg~     BCG infused over 120 min once a week for 2 weeks, followed by 40 mg electromotive mitomycin~     (intravesical electric current 20 mA for 30 min) once a week as one cycle for three cycles~     (n=107). Complete responders underwent maintenance treatment: those assigned BCG alone had~     one infusion of 81 mg BCG once a month for 10 months, and those assigned BCG and mitomycin~     had 40 mg electromotive mitomycin once a month for 2 months, followed by 81 mg BCG once a~     month as one cycle for three cycles. The primary endpoint was disease-free interval;~     secondary endpoints were time to progression; overall survival; and disease-specific~     survival. Analyses were intention to treat.~   "
162221|NCT01442506|"~     Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus.~     Chromoendoscopy after local acetic acid application enables recognition of the mucosal~     surface architecture. The new available EPKi processor (Pentax, Japan) enables HD+ resolution~     above HDTV standard. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction~     with i-Scan or acetic acid to diagnose Barrett`s esophagus. The primary endpoint of the~     current prospective study is to investigate the diagnostic yield of virtual chromoendoscopy~     using the i scan function as compared to acetic acid chromoendoscopy and 4-quadrant biopsies.~      Patients with visible columnar lined lower esophagus (CLE) are included. After standardized~     PPI therapy (14 days; standard dosage) patients were randomized at a 1:1 ratio to undergo~     either chromoendoscopy in conjunction with acetic acid application or i-Scan. Biopsies are~     taken in a targeted fashion using acetic acid or i scan and afterwards 4-quadrant biopsies~     are taken.~   "
162222|NCT01442493|"~     The purpose of the study is to determine whether a change in the rules and staff roles in~     methadone treatment programs will result in greater lengths of stay in treatment and lower~     rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone~     treatment as usual.~   "
162223|NCT01442480|"~     Exposure to ambient levels of air pollution increases cardiovascular morbidity and mortality.~     Advanced age is among the factors associated with susceptibility to the adverse effects of~     air pollution. Dietary fatty acid supplementation has been shown to decrease cardiovascular~     risk through multiple mechanisms. This study evaluated the efficacy of supplementation with~     marine fish oil or olive oil in protecting against cardiovascular effects induced by~     controlled exposure of middle-aged healthy volunteers to concentrated ambient air pollution~     particles. Subjects (ages 50 to72 years), were randomly assigned to receive 3 g/d of fish oil~     (1.2 g eicosapentaenoic acid and 0.82 g docosahexaenoic acid), or olive oil (3g/d) for 28 d.~     Subjects were then exposed to concentrated ambient air pollution particles or filtered air~     for 2 hr on sequential days. Heart rate variability (HRV), plasma lipids, coagulation~     markers, and endothelial function measured by flow-mediated dilation of the brachial artery~     (FMD) were assessed pre-, immediately post-, and 20 hr post-exposure.~   "
162224|NCT01442467|"~     This study aims to evaluate the accuracy of the echocardiographic data obtained from patients~     with calcifications in the mitral valve who are undergoing a cardiac (heart) catheterization.~      Echocardiography is a non-invasive (does not break the skin) procedure used to see an image~     of the heart. It uses harmless sound waves to create an image of the heart on a computer~     screen. These images will show the valves of the heart, how well the heart is pumping blood,~     the blood flow across these valves and how large the heart is. A silver paddle-shaped device~     is moved easily over the skin to capture these images.~      Calcification (hardening) of the heart valves and heart rings (fibrous tissue surrounding the~     valves) is a common finding and it increases with age. The presence of calcification changes~     the blood flow through the heart valves. This makes any echocardiographic data (information)~     obtained from patients with calcifications difficult to interpret.~   "
162225|NCT01442454|"~     The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic~     pancreatitis with surgical pathology.~   "
162237|NCT01442285|"~     The purpose of this study is to understand more about meeting the psychosocial needs of~     people who have cancer.~   "
166728|NCT01383369|"~     The purpose of this study is to evaluate sleep cycle before and after fast-track arthroplasty~     (3 days before and 10 days after) combined with cognitive testing preoperatively, on~     postoperative day 1,2,10.~   "
162227|NCT01442428|"~     Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons~     worldwide, including in South East Asia. Significant numbers of patients experience~     tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after~     ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent~     randomized-controlled trial showed the benefit of prednisone over placebo in reduction of~     days of hospitalization and invasive procedures. The investigators hypothesize that~     nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for~     treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that~     adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase~     inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a~     2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for~     the symptomatic and immunologic control of TB-IRIS.~   "
162228|NCT01442415|"~     Childhood cancer survivors (CCS) are prone to develop obesity and are at increased risk of~     developing cardiovascular disease and type 2 diabetes compared to the general pediatric~     population. Few lifestyle modification trials have been conducted in overweight/obese CCS and~     it is unclear whether CCS respond similarly to lifestyle modification compared to~     overweight/obese individuals who have not had cancer (non-CCS). We propose a 3-year pilot~     study that will enroll separate cohorts of overweight/obese CCS and overweight/obese non-CCS~     every September into a family-based lifestyle modification program consisting of weekly~     sessions at the University of Minnesota. The goal of the program will be to facilitate~     improved physical fitness, weight management, heart health, and quality of life.~   "
162229|NCT01442402|"~     Aim 1:~      Determine if there is an association between the APOL1 risk variants and allograft survival~     and function in African Americans~      Aim 2:~      Determine if there is an association between the presence of APOL1 risk variants in an~     African American kidney transplant recipient and the risk of recurrent disease~      Aim 3:~      Investigate mechanisms of APOL1 associated kidney disease by prospectively following African~     American kidney transplant recipients throughout their clinical course.~   "
162230|NCT01442376|"~     The primary objective is to evaluate the efficacy of two different doses of IV palonosetron~     in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through~     120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The~     secondary objectives are to evaluate the safety and tolerability of IV palonosetron in~     pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of~     pediatric CINV patients.~   "
162231|NCT01442363|"~     This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is~     designed to determine the effects of BLI-1300 ointment on perianal pain associated with~     active Perianal Crohn's Disease (PCD).~   "
162232|NCT01442350|"~     The cardiac variant of the Fabry disease is a rare cardiomyopathy affecting 1/50000~     individuals in general population. It is generally diagnosed in advanced stages of the~     disease, because it presents clinical features very similar to the hypertrophic~     cardiomyopathy ones, making difficult the correct diagnosis. In Fabry disease there is a~     remodeling process of the myocardial interstitium and apoptosis of myocytes which leads to~     fibrosis development and later systolic dysfunction. The investigators propose to evaluate~     the utility of several biomarkers in the diagnosis of this cardiomyopathy, to facilitate the~     early diagnosis, which is clue to establish early enzyme replacement therapy or intensify the~     patients' follow up. In order to achieve this objective, the investigators will analyze~     markers of endothelial dysfunction, fibrosis and apoptosis in peripheral blood samples of~     patients carrying the mutation but without clinical manifestations and the investigators will~     compare their levels with dose obtained from two different control groups: diagnosed patients~     presenting clinical manifestations or index cases and healthy controls without carrying the~     mutation.~   "
162233|NCT01442337|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of a single~     intravenous dose of ASP8597 in kidney transplant recipients.~   "
162234|NCT01442324|"~     Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation~     (IRE) as the sole treatment of nodules not considered treatable by resection or thermal~     ablation.~   "
162235|NCT01442311|"~     Drug users account for a disproportionately large burden of hepatitis C virus (HCV)~     infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients~     who use drugs regularly during HCV treatment. Because HCV treatment is most effective when~     patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve~     HCV treatment adherence need to be developed and evaluated. The investigators designed the~     HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy~     provided on-site at a methadone clinic. The primary objective of this trial is to determine~     whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is~     more efficacious than standard DOT with weekly provider-administered pegylated interferon~     (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV~     treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with~     increased adherence and rates of sustained viral response compared with PEG-DOT.~   "
162236|NCT01442298|"~     The use of bloodless field is a helpful and important method in orthopedic surgery. The~     surgery can be done without interrupting bleedings, while keeping an exact overlook of the~     anatomy. However the method is not without risks, and complications of various kind may~     occur. One of the most important factors to minimise the risk of complications, is to keep~     the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated~     neuromuscular abnormalities after bloodless field among many patients which may lead to a~     prolonged rehabilitation period since they cause a postoperative weakness in the muscles.~     Although in these studies an unnecessary high tourniquet pressures were used and the EMG~     tests were made 6 weeks and 6 months after the surgery.~      With today's demand for fast rehabilitation, there is a need for better knowledge if lower~     tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities.~      Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood~     flow. It accounts for a patients limb and vessel characteristics and the type and fit of the~     tourniquet cuff. The method has developed and is now simplified, by using an automatic~     (plethysmographic) sensor placed on the second toe on the involved limb, and after~     administration of anaesthesia, and immediately before limb preparation and draping it~     measures the limb occlusion pressure.~      When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP~     pressure measured. The LOP method is still rarely used it has been seen as difficult and time~     consuming.~      The primary aim of this study is to investigate whether you can reduce the used tourniquet~     pressure with the new LOP measurement technique and still have a adequate bloodless field;~     and if this will lead to any clinical difference regarding postoperative pain. The secondary~     aim is to investigate the difference between the test groups concerning muscle function and~     wound healing and if these are remaining and of clinical importance. The third aim is to~     study how common neuromuscular abnormalities are after the use of bloodless field with lower~     cuff pressures and if there are any differences between the standard method and the LOP~     method.~   "
162240|NCT01442246|"~     PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to~     10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24~     months after radical prostatectomy in patients with high risk of recurrence.~      SECONDARY OBJECTIVE(S):~        -  PSA evolution~        -  Evaluation of testosterone level~        -  Specific survival~        -  Overall survival~        -  Tolerance~        -  Quality of life (QLQ-C30 questionnaires)~   "
162241|NCT01442233|"~     In more than 40 % of multiple sclerosis (MS) patients experiencing relapse, residual~     disability accumulates in spite of steroid treatment. Plasma exchanges are frequently used~     but there is no established evidence of their efficacy.~   "
162242|NCT01442220|"~     Pituitary adenomas is a very common disease, but the cause and genetics hasn't been~     identified. The investigators are going to use genome-wide association study to identify~     genes that may be related to pituitary adenomas.~   "
162243|NCT01442207|"~     The purpose of the study is to compare the role of cervical cerclage versus expectant~     management in women with complete placenta previa (≥ 10mm over internal os) presenting with~     shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.~   "
162244|NCT01442194|"~     The purpose of this world-wide prospective parallel-cohort study in patients with relapsing~     forms of MS, either newly treated with fingolimod or receiving another disease-modifying~     therapy, is to further explore the incidence of selected safety- related outcomes and to~     further monitor the overall safety profile of fingolimod under conditions of routine medical~     practice.~   "
162245|NCT01442181|"~     The purpose of this study is to compare a minimally invasive surgical procedure and~     medication management in stroke patients with Atrial Fibrillation. The two treatment options~     are a minimally invasive surgical procedure or the use of medications.~   "
162246|NCT01442168|"~     The purpose of this study is to determine the tolerability and pharmacokinetics of~     Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil®~     (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated~     malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected~     erythrocyte sequestration and rosette formation.~      The study consists of a dose escalation part (part 1) followed by an open labelled,~     randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone~     (part 2).~   "
162247|NCT01442155|"~     This observational study evaluates the efficacy and safety of capecitabine in combination~     with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data~     were collected from each participant for up to 36 months or until disease recurrence.~   "
162248|NCT01442142|"~     The objective of this study is to pilot test, evaluate and compare the effects of Cue~     Reactivity and Sensitivity Training (CRST) and Children's Appetite Awareness Training (CAAT)~     in 48 children aged 8-12 years old. The central hypothesis is that CRST and CAAT will reduce~     eating in the absence of hunger in overweight children immediately following treatment and~     6-months post treatment.~      The primary aim of this proposed study is to evaluate the efficacy and compare the~     effectiveness of Cue Responsivity and Sensitivity Training (CRST) or Children's Appetite~     Awareness Training (CAAT) in decreasing eating in the absence of hunger (EAH) in overweight~     children. Following this first intervention, a second intervention to determine the efficacy~     of a combination program (combined CAAT & CRST) will be implemented.~      The secondary aim of this study is to evaluate change in the following related measures for~     both children and adults who participated in CRST, CAAT, and the combination program: BMI for~     age, food intake, perceptions of control over eating, and self-efficacy in managing high-risk~     food situations.~   "
162249|NCT01442129|"~     The main purpose of this research is to determine whether injecting mesenchymal precursor~     cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD)~     is safe. MPCs are normally present in human bone marrow, and have been shown to increase the~     development of blood vessels and new heart muscle cells in the heart. In addition, this~     research is being done to test whether injecting the MPCs into the heart is effective in~     improving heart function.~   "
162250|NCT01442116|"~     The study hypothesis is stress-related regional tissue dynamics is related to left~     ventricular outflow tract blood flow.~   "
162251|NCT01442103|"~     This investigation will be conducted in the US as a single-center study to evaluate in total~     10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.~   "
162252|NCT01442090|"~     Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with~     metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be~     randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.~   "
162253|NCT01442077|"~     Low intensity shock waves(LISW) have been proven in animal studies to induce local growth of~     new blood vessels. The investigators hypothesized that LISW therapy could improve the~     symptoms of patients with erectile dysfunction resulting from a problem of blood supply who~     respond to oral therapy (PDE-5 inhibitors). The current study will check 4 different arm.~   "
162254|NCT01442064|"~     This is an open-label, multicenter, extension study of intravitreally administered~     ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g,~     NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV)~     secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a~     Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g~     (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema~     secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month~     observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018)~     or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the~     previous study.~   "
162267|NCT01441895|"~     The study objective is to assess changes in corneal sensation and dry eye signs and symptoms~     following cataract extraction/femtosecond arcuate relaxing incisions.~      Our clinical hypothesis is to determine if a combination of cataract surgery and femtosecond~     arcuate relaxing incisions lead to a reduction in corneal sensation and the onset or~     worsening of dry eye signs and symptoms.~   "
162268|NCT01441882|"~     This phase II trial studies how well dasatinib works in treating patients with chronic~     lymphocytic leukemia (CLL). Dasatinib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~   "
162255|NCT01442051|"~     The purpose of this study is to help us learn how to lower the risk of a blood transfusion~     during surgery to remove ovarian cancer. Acute normovolemic hemodilution (ANH) is a technique~     performed in the operating room before the procedure begins that may reduce the risk of~     needing a transfusion during ovarian cancer surgery. During surgery, the patient's own blood~     is given back to them when needed, usually due to bleeding. If you don't need blood during~     surgery, your own blood will be given back at the end of the case.~      The idea behind ANH is that that by removing the blood and replacing it with other fluids,~     the remaining blood becomes diluted. This diluted blood is then lost during surgery, usually~     due to bleeding. The original non-diluted blood is then transfused back as needed. This may~     mean a lower chance of needing an additional blood transfusion.~      ANH has been studied at this hospital for other types of cancer. These studies suggest that~     ANH may help conserve blood. Although most studies suggest that ANH can be performed safely,~     one study showed that ANH could be associated with a higher rate of serious bowel~     complications than standard treatment. In this study, patients who underwent ANH had a higher~     rate of anastomotic leaks during bowel surgery. An anastomotic leak occurs when two ends of~     bowel that have been cut and sewn back together (the anastomosis), fall apart. The~     investigators don't know whether ANH will result in higher rates of anastomotic leaks in~     patients having ovarian cancer surgery. In fact, in another study evaluating ANH in patients~     having the kind of bowel resections that often occur in ovarian cancer surgery (the colon),~     no increased risk of anastomotic leaks was observed. For these reasons, researchers at MSKCC~     are conducting a study to find out if ANH can be used safely in patients undergoing surgery~     for ovarian cancer.~   "
162256|NCT01442038|"~     This study will evaluate the efficacy of ranolazine as compared with placebo when used as~     part of standard medical therapy in chronic angina subjects with incomplete revascularization~     post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on~     the composite of ischemia-driven revascularization or ischemia-driven hospitalization without~     revascularization.~   "
162257|NCT01442025|"~     To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab)~     trough level measurements and adjustment of dosing based upon these levels by means of two~     different standardized algorithms in comparison with 'standard of care' IFX treatment and its~     effects on clinical and endoscopic outcomes.~   "
162258|NCT01442012|"~     To evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting~     (PONV) in Ambulatory Surgery.~   "
162259|NCT01441999|"~     The treatment of adult deformity has improved with the development and use of modern~     segmental instrumentation, including posterior instrumentation. However, the incidence of~     proximal junctional kyphosis (PJK) caused by the accelerated degeneration of the joint~     capsules and smaller articular processes in the proximal junctional region has also been~     noted.~      One potential way of decreasing PJK is to decrease the structural rigidity of the construct~     at the top thereby providing a transition to the non-instrumented spine and allowing for less~     facet capsule and muscle disruption.~   "
162260|NCT01441986|"~     The purpose of this trial is to demonstrate that dextromethorphan (DXM) and amantadine~     compared to placebo exert blood glucose (BG) lowering effects following an oral glucose~     tolerance test (OGTT) in male subjects with T2DM.~   "
162261|NCT01441973|"~     The purpose of this study is to determine whether elotuzumab will improve response in~     patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the~     health of the body's immune system)~   "
162262|NCT01441960|"~     Electroconvulsive therapy (ECT) is the transcutaneous application of small electrical stimuli~     to the brain to produce generalized seizures for the treatment of selected psychiatric~     disorders such as severe depression. The aim of ECT is to induce a therapeutic tonic seizure~     where the person loses consciousness and has convulsions. Patients need general anesthesia~     and neuromuscular blockade to treat pain and avoid excessive tonic clonic motor contraction~     that might be associated with compression fractures. Neuromuscular blocking drugs (NMBD) are,~     therefore, administered after induction of general anesthesia to induce neuromuscular~     blockade. Despite the importance of NMBDs to provide optimal conditions for ECT treatment,~     the optimal NMBD dose to achieve acceptable neuromuscular blockade without excessive or~     untoward effects has not previously been identified in any study and in a prospective~     randomized fashion. The aim of this study is, therefore, to identify the optimal NMBD dose of~     two commonly used neuromuscular blocking agents (succinylcholine and rocuronium) in order to~     optimize the muscle strength modulation during ECT that facilitates ECT with the minimal side~     effects.~   "
162263|NCT01441947|"~     The study drug cabozantinib works by inhibiting several different proteins which are believed~     to be involved in breast cancer tumor growth, its ability to spread, and its ability to form~     new blood vessels. This drug has been used in other research studies and information from~     those other research studies suggests that this drug may help to prevent cancer growth.~      The single agent portion of this study is now closed to accrual. This research study is now~     examining the efficacy of cabozantinib in combination with fulvestrant for treatment of~     hormone-receptor-positive breast cancer that has spread to bone.~   "
162264|NCT01441934|"~     Although pulmonary hypertension (PH) is a quite frequent complication of advanced pulmonary~     diseases, and it is an independent prognostic factor, until now no evidence-based treatment~     approach exists for those patients.~      This study will address if the drug sildenafil can lower pulmonary vascular resistance in~     patients with significant pulmonary hypertension (high blood pressure in the lungs)~     associated to chronic obstructive pulmonary disease (COPD). It will see if this treatment can~     improve effort capacity, quality of life without causing a deterioration in pulmonary gas~     exchange (mainly arterial oxygenation).~      Patients 18 years of age and older with moderate COPD and pulmonary hypertension (mean~     pulmonary arterial pressure >30 mmHg) may be eligible for this study. Participants are~     randomly assigned to receive sildenafil or placebo (pill with no drug) for 16 weeks.~      Before starting treatment (baseline), and a the end of the study, the patients have a~     comprehensive assessment including:~        -  a chest x-ray and CT scan (only at baseline);~        -  pulmonary function tests to measure how much air the patient can breathe in and out, and~          the capacity of diffusion of gases;~        -  arterial blood gases analysis (for safety reason this examination is performed at~          baseline, before the randomization after one hour from the administration of a tablet~          (20 mg) of sildenafil, and every month)~        -  an echocardiogram (heart ultrasound) (only at baseline);~        -  a 6-minute walk test to measure exercise capacity;~        -  a quality-of-life assessment (SF-36 questionnaire)~        -  a right heart catheterization to evaluate the severity of hypertension~      At the end of the 16-week period, patients may opt to continue to receive sildenafil and~     monitoring in an open-label phase of the study for up to 1 year.~   "
162265|NCT01441921|"~     Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance~     status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated~     abnormalities.~   "
162270|NCT01441856|"~     The added value of the laparoscopic hemihepatectomy compared to the open hemihepatectomy has~     never been studied in a randomized controlled setting. Therefore, the multicenter~     international ORANGE II PLUS - trial has been constructed and will provide evidence on the~     merits of laparoscopic versus open hemihepatectomy in terms of time to functional recovery,~     hospital length of stay, intraoperative blood loss, operation time, resection margin, time to~     adjuvant chemotherapy initiation, readmission percentage, (liver-specific) morbidity, quality~     of life, body image, reasons for delay of discharge after functional recovery, long term~     incidence of incisional hernias, hospital and societal costs during one year and overall~     five-year survival.~   "
162271|NCT01441843|"~     The purpose of this study is to determine whether lorazepam, which is used to lower~     preoperative anxiety, also improves postoperative recovery.~      This study data will also be used for further research aiming to identify vulnerable patients~     in the day-case surgery setting.~   "
162272|NCT01441830|"~     The purpose of this study is to determine whether rESWT (radial extracorporeal shock wave~     therapy) combined with supervised exercises will improve function and reduce pain in~     subacromial shoulder pain compared with supervised exercises alone.~   "
162273|NCT01441817|"~     The purpose of this study was to determine if internal fixation of the medial malleolus is~     necessary following open reduction and internal fixation of the lateral and, if required, the~     posterior malleolus treating displaced bi-or trimalleolar ankle fractures.~   "
162274|NCT01441804|"~     Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response~     to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that~     there is no important difference in effect between the two treatment effect.~   "
162275|NCT01441791|"~     The purpose of this international, multicentre, double-blinded randomized controlled trial is~     to determine if the open lung approach providing recruitment maneuvers and PEEP(Positive~     End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves~     respiratory function in the immediate post-operative period after major abdominal surgery.~      Participating centres throughout the world will include a total of 900 adult patients~     undergoing general anesthesia for open abdominal surgery with high or intermediate risk for~     post-operative pulmonary complications. Patients are randomized and intra-operatively~     ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment~     maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment~     maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge~     and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication~     (see below). Secondary endpoints are post-operative extra-pulmonary complications,~     intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care~     Unit) (re-) admission, and length of hospital stay.~   "
162276|NCT01441778|"~     The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is~     superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms~     in children with allergic rhinitis.~   "
162277|NCT01441765|"~     CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug~     that are known to target specific cells (in this case, cells in the immune system) The DC RCC~     Vaccine is agent that tries to help the immune system to recognize and fight against cancer~     cells.~      The purpose of this research study is to determine the safety of CT-011 alone, and in~     combination with the Dendritic Cell Renal Cell Carcinoma (DC RCC) vaccine. The investigators~     are also trying to find out what effect the combination has on the disease, and on your~     immune system.~   "
162278|NCT01441752|"~     The investigators performed a multi-center, randomized, controlled, double-blind, prospective~     study on evaluating effect of chemotherapy combined with or without integrated TCM on quality~     of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. The investigators~     plan to involve 600 cases for observation in 3 years (300 cases for each group), expecting~     that QOL of postoperative NSCLC patients can be improved by integrated TCM combined with~     chemotherapy compared to that by chemotherapy alone.~   "
162279|NCT01441739|"~     Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity and~     mortality (20-40%), affecting predominantly premature neonates. NEC continues to present a~     diagnostic challenge to clinicians. The initial clinical manifestations of NEC are~     non-specific and indistinguishable from other gastrointestinal disorders and sepsis.~      The first goal of this study is to find and evaluate tests to diagnose NEC at an early stage.~     For the development of new diagnostic markers, the investigators require knowledge of~     pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the~     second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of~     the pathophysiology of NEC can offer the possibility to develop new therapeutical treatments.~   "
162280|NCT01441726|"~     Rationale: In Canada, as in most industrialized countries, Alzheimer's disease and other~     related dementia are increasingly prevalent in older people. At an advanced stage,~     institutionalization in a long-term care (LTC) setting will be the fate of a majority of~     patients. A structured palliative care approach is increasingly used for cancer patients, but~     is still rarely accessible in LTC institutions for older people with advanced or terminal~     dementia. This approach should include a more systematic detection and treatment of pain and~     other physical and psychological symptoms during the last weeks of life, as well as better~     communications between patients, families and care staff, particularly relating to advanced~     care directives. Objectives: The general objective of this study is to implement and evaluate~     a multidisciplinary and multidimensional program of palliative and end-of-life care for older~     persons with terminal dementia in LTC facilities. Methodology: The intervention program will~     include five components:~        1. daily involvement of a nurse from the regular staff in the LTC facility as a change~          agent;~        2. awareness sessions with administrators and staff on the importance of high quality~          palliative care in dementia;~        3. a training program for physicians and all the staff involved in direct care of patients;~        4. systematic discussions with families and distribution to families of a document on~          different aspects of palliative care in dementia;~        5. systematic clinical care by regular staff for the control of pain, respiratory symptoms~          and mouth care. The program will be implemented in two LTC settings (one in Quebec City~          and one in Sherbrooke, Quebec, Canada), and results will be compared with the LTC~          control settings where usual care will be applied without implementation of the program.~   "
162305|NCT01441401|"~     This investigation aims to understand the following issues in pediatric patients, as well as~     to assess the need of a special investigation and a post-marketing clinical study:~        -  The frequency of treatment related adverse events.~        -  The frequency of efficacy assessment.~        -  Treatment related unlisted adverse events in Japanese Package Insert.~        -  Risk factors likely to affect the frequency of treatment related adverse event.~   "
187250|NCT01113580|"~     The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is~     safe and elicits an immune response to seasonal influenza in healthy adults.~   "
162281|NCT01441713|"~     Patients with advanced prostate cancer usually receive some kind of pharmaceutical castration~     or undergo surgical castration. At the investigators department the pharmaceutical treatment~     is most often given with a 3 month interval.~      Over the last few years new drugs, which allow for lees frequent treatment, have been~     developed. The purpose of this study is to assess how the treatment affects patients and if~     our current patients would prefer to receive treatment at different intervals than they do at~     the present time. At the same time the investigators will assess how surgical treatment~     affects our patients. This will be assessed by patient questionnaires administered at our~     clinic.~   "
162282|NCT01441700|"~     Compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss of~     monitoring in patients undergoing lumbar disc surgery extubated in prone position and supine~     position.~   "
162283|NCT01441687|"~     This randomized pilot phase I trial studies the best way, either expressed prostatic~     secretion (EPS) or post massage urine (PMU) biomarkers, of predicting biopsy results in~     patients undergoing prostate biopsy. Studying samples of urine in the laboratory may help~     doctors detect prostate cancer. It is not yet known whether EPS or PMU biomarkers are more~     effective in predicting prostate biopsy results~   "
162284|NCT01441674|"~     The primary purpose for this study is to determine if children who receive Occupational~     Therapy while they are an inpatient in the hospital will be more motivated to participate in~     therapy as well as increase the amount of time they will work during that particular session~     when a therapy dog is present during their sessions. The investigators will also be~     collecting data regarding a child's heart rate and blood pressure prior to the session~     starting and ending to determine if having a therapy dog present also helps relax a child.~   "
162285|NCT01441661|"~     This non-interventional study includes patients with advanced renal cell carcinoma who are~     treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial~     is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine~     use of Sunitinib.~   "
162286|NCT01441648|"~     More than 1 million people worldwide wear soft contact lenses for refractive error~     correction. However, severe sight threatening complications due to contact lens wear such as~     contact lens-related microbial keratitis (CLMK) are about 1 per 2500 persons per year. The~     rate of infection increases drastically to 1 per 500 person per year if lenses were worn~     overnight. Recently, color tinted cosmetic soft contact lenses, which are essentially soft~     contact lenses with a color tinted annular ring, are gaining increasing popularity especially~     among the younger and Asian population desiring a change in iris color or the doll-eyed look.~     However, studies on the effect of these lenses on the ocular surface have been scarce.~     Recently, a report of 12 cases of lens-related microbial keratitis due to wear of the color~     tinted lenses have been reported. Others reported of decreased contrast sensitivity,~     increased higher order aberrations, and temporary changes in corneal topography due to color~     tinted lens wear. Nevertheless, comprehensive and prospective study has not yet been done.~     Thus, the purpose of this study is to conduct a prospective observational study to determine~     the influence of color tinted cosmetic contact lens wear both on visual performance and~     ocular surface alterations.~   "
162287|NCT01441635|"~     The purpose of this proof-of-concept study is to determine whether elagolix (ABT-620) is safe~     and effective in the treatment of pre-menopausal women, 20 to 49 years of age, with heavy~     uterine bleeding associated with uterine fibroids. The effect of elagolix (ABT-620) on~     uterine size, fibroid size, and bleeding associated with uterine fibroids will be assessed~     versus placebo, and in combination with add-back therapy.~   "
162288|NCT01441622|"~     Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with~     Obstructive Sleep Apnea Syndrome (OSAS).~      The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during~     attended in-hospital polysomnography in patients with Obstructive Sleep Apnea Syndrome.~   "
162289|NCT01441609|"~     An observational study will be performed in subjects aged 3-65 years old to describe the~     dynamic changes of cellular immunity after vaccination of hepatitis B vaccine, and to find~     out the expression levels of Th9 cells and IL9 in subjects with different response to the~     primary immunization (3 single -dose injunctions).~   "
162290|NCT01441596|"~     The aim of this study is to investigate the efficacy and safety of afatinib alone or in~     combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic~     breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based~     therapy~   "
162291|NCT01441583|"~     The purpose of the IVORY Study is to gather data to support global submissions/approvals for~     some models of the Ingenio device family.~   "
162292|NCT01441570|"~     In an open label analysis, nebivolol has been shown to have a positive impact on quality of~     life in the general hypertensive population. That is, patients treated with nebivolol~     reported less side effects compared to those treated with metoprolol. Also, more nebivolol~     treated patients reached normalization of blood pressure. Although there is no data, it is~     believed that the impact would be similar in renal transplant recipients.~      The primary goal of this study is to determine if nebivolol will improve the quality of life~     measurements of kidney transplant recipients as compared to those treated with metoprolol~     succinate. This will be measured by comparing the scores of four quality of life~     questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of~     this study are to determine if the use of nebivolol is cost-effective in the renal transplant~     recipient; determine if there is a change in urine protein excretion and renal function with~     the use of nebivolol; and determine the number of patients that maintain or achieve a target~     blood pressure of ≤ 120/80 mmHg.~   "
162348|NCT01440829|"~     The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on~     plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt~     (TIPS) procedure.~   "
162349|NCT01440816|"~     This phase II trial studies the effectiveness of ImmunoPulse IL-12® in treating patients with~     Merkel cell cancer. ImmunoPulse IL-12® is the combination of intratumoral interleukin-12 gene~     (also known as tavokinogene telseplasmid [tavo]) and in vivo electroporation-mediated plasmid~     deoxyribonucleic acid [DNA] vaccine therapy (tavo-EP) administered using the OncoSec Medical~     System (OMS). Placing the gene for interleukin-12 into Merkel cells may help the mount an~     effective anti-tumor immune response to kill tumor cells.~   "
162293|NCT01441557|"~     Main objectives:~      Evaluate the effectiveness of an administration of 3,4-diaminopyridine (FIRDAPSE ®) in severe~     botulinic poisoning in measuring the effect on electrophysiological and respiratory~     parameters~      Secondary Objective:~      Study the natural history of electrophysiological and respiratory parameters during the~     botulinic intoxication~      Primary endpoint:~      Clinical, electrophysiological and respiratory before and after administration of~     3,4-diaminopyridine.~      Study Design:~      Pilot study, prospective, interventional.~      Study population:~      Case series (n = 8 patients) suffering from botulinic type A, respiratory failure, but with~     no other organ failure~      Experimental treatment :~      3,4-diaminopyridine, FIRDAPSE ® (BioMarin) The dosage will be gradually increased according~     to a predetermined scheme and will not exceed 60 mg / day and 20 mg / dose.~      Statistics:~      Intra-individual comparison of physiological parameters measured before and after~     administration of 3,4-diaminopyridine. Electromyographic and respiratory parameters will be~     measured for each patient. Then a dose of 10 mg of 3,4-diaminopyridine will be administrated.~     If this dose is well tolerated and provides a relative improvement of 10% for at least one of~     the parameters studied, the dose will be maintained at 10 mg for 48 hours 3 times a day then~     increased to 20 mg.~      The primary endpoint is the change in the amplitude of muscle response evaluated by the~     subtraction of amplitude at T1.5 and T0.~   "
162294|NCT01441544|"~     Increasing physical activity continues to be a challenge among many individuals, particularly~     those who are overweight. Recent data from the National Health and Nutrition Examination~     Survey (NHANES) showed that individuals who reported engaging in a variety of activities were~     more likely to meet national physical activity recommendations compared to those who reported~     no variety. Incorporating a variety of activities into a physical activity program may be a~     way to increase physical increase physical activity levels.~      One method to increase variety in physical activities is to use active videogames. Videogames~     that use motion sensors allow a gamer to physically perform a variety of activities. Thus,~     the purpose ot this laboratory-based investigation is to conduct a study to examine the~     effect of engaging in a greater variety of active videogames on energy expenditure in 30~     non-obese, regularly active adults.~   "
162295|NCT01441531|"~     The purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po)~     before surgery will help prevent the development of tourniquet pain and hypertension while~     the tourniquet is inflated during orif of tibia fracture.~   "
162296|NCT01441518|"~     Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with~     increased perinatal and maternal complications. The most serious maternal complication is the~     risk of developing type 2 diabetes after 10-12 years of the delivery. Perinatal complications~     include fetal macrosomia with consequent increased risk of obstetrical trauma and~     hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and~     metabolic disorders at birth. Regardless of the diagnosis of diabetes and mild gestational~     hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. For~     the tight control of blood glucose, pregnant women are treated as home care (outpatient) or~     hospital care. Objective: To evaluate the cost-effectiveness and safety of home versus~     hospital care of gestational diabetes and mild gestational hyperglycemia.~   "
162297|NCT01441505|"~     Recently, interest has emerged in the use of ketamine as an antidepressant. Recent~     placebo-controlled clinical trials administering a single dose and an open label trial giving~     repeated doses shown that ketamine is markedly superior to placebo at reducing depression,~     including in treatment-resistant patients, and that its antidepressant effects have a very~     rapid onset.~      This clinical study consists of two phases. In Phase I, participants who satisfy inclusion~     criteria will receive ketamine at variable doses (0.1mg/kg-0.5mg/kg) or a placebo (saline, or~     0.01mg/kg midazolam) once a week over up to 6 weeks. If participants qualify for Phase II,~     they will receive repeated sessions of ketamine at variable doses over three weeks. During~     both phases, mood, psychiatric, and neuropsychological outcomes will be measured.~   "
162298|NCT01441492|"~     This randomized prospective trial is designed to test the hypothesis that pancreatectomy~     without routine intraperitoneal drainage does not increase the severity or frequency of~     complications within 60 days of surgery.~   "
162299|NCT01441479|"~     The purpose of this study is to demonstrate the ability of the Strep A Fluorescent~     Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence~     of Strep A when compared to culture.~   "
162300|NCT01441466|"~     The purpose of this study is to investigate the effect of cohort isolation of RS(respiratory~     syncytial virus)-positive bronchiolitis versus RS-negative bronchiolitis on prevention of~     co-infection and clinical disease severity. Furthermore the investigators want to elucidate~     general epidemiological data on bronchiolitis concerning viral causes and the associated~     clinical severity.~      The investigators want to conduct a prospective cohort study, comparing incidence of~     co-infection and clinical severity, in two cohort: one with isolation of RS positive~     bronchiolitis as a separate cohort within bronchiolitis and one without isolation (all~     children with RS-negative bronchiolitis are nursed together independent of viral agent)~   "
162301|NCT01441453|"~     The purpose of this study is to determine whether liver transient elastography performed~     before the surgical procedure is able to predict liver failure in patients undergoing~     hepatectomy for hepatocellular carcinoma.~   "
162302|NCT01441440|"~     This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group~     study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and~     venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study~     consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The~     follow-up visit will be evaluated after 2 weeks of last study medication dosing.~   "
162303|NCT01441427|"~     With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors~     ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and~     necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating~     Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human~     developmental biology. Among these roles, they have trophic actions on villous height and~     bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of~     enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding~     intolerance and /or NEC in preterm infants.~   "
162306|NCT01441388|"~     Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of~     patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment~     while the majority of patients will eventually develop evasive resistance and exhibit disease~     progression while on therapy. It is proposed that mesenchymal-epithelial transition factor~     (c-MET) and its ligand hepatocyte growth factor (HGF or scatter factor) contribute~     significantly to VEGF inhibitor resistance such that combining a c-MET inhibitor with a VEGF~     inhibitor will provide additional clinical activity compared to VEGF inhibitor alone. This~     hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in combination with~     individual VEGF inhibitors. Three combinations will be prioritized, namely crizotinib plus~     axitinib, crizotinib plus sunitinib and crizotinib plus bevacizumab, with a fourth~     combination, crizotinib plus sorafenib to be tested only if crizotinib does not combine with~     either axitinib and/or sunitinib.~   "
162307|NCT01441375|"~     This study is a retrospective chart review of sickle cell patients and will include patients~     whom have received blood transfusions and those whom have not. Of the transfused patients, it~     will also include those whom have received chelation therapy and those whom have not.~   "
162308|NCT01441362|"~     The purpose of this study is to devise the method to reduce laryngeal injuries during~     double-lumen tube intubation.~   "
162309|NCT01441349|"~     The purpose of this study is to compare the efficacy of Simvastatin and Irinotecan/Cisplatin~     chemotherapy with Irinotecan/Cisplatin chemotherapy alone in Extensive disease-small cell~     lung cancer.~   "
162310|NCT01441336|"~     Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric~     cancer, there have been few reports of the efficacy of LAG in the management of advanced~     gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and oncologic~     safety of laparoscopic gastrectomy for AGC.~   "
162311|NCT01441323|"~     The investigators are conducting an intervention study to examine the effects of a 16-week~     exercise and diet interventions on prevention of disease, specifically type 2 diabetes and~     heart disease, in African American youth. Sixty overweight African American boys and girls~     will be recruited and placed in one of the following intervention groups: 1) Control Group~     (delayed intervention), 2) Dietary Education Group (nutrition education focused on reducing~     sugar & soda, increased fiber & whole grain intake), or 3) Combination of Strength Training~     (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary~     Education (nutrition education focused on reducing sugar & soda, increased fiber & whole~     grain intake). The investigators will assess which intervention group has the most effects on~     health parameters such as weight, body composition, and insulin related measures.~   "
162312|NCT01441310|"~     There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer~     sentinel node mapping.~      The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy~     with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green~     (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.~   "
162313|NCT01441297|"~     Although chemotherapy is the primary treatment option for small cell lung cancer (SCLC),~     longterm survival is rare. SCLC is initially chemosensitive, but rapidly relapses in a~     chemoresistant form with an overall survival of <5%. Consequently, novel therapies are~     urgently required and will likely arise from an improved understanding of the disease~     biology. Some preclinical studies have showed that fibroblast growth factor-2 induces~     proliferation and~   "
162314|NCT01441284|"~     Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter~     study evaluating the efficacy of pramipexole on essential tremor.~   "
162315|NCT01441271|"~     The investigators hypothesize that minimally invasive ileal diversion with intraoperative~     colonic lavage using a high volume polyethylene glycol/electrolyte solution will clear~     Clostridium difficile infection resulting in eradication of Fulminant C. difficile colitis~     (FCDC) while preserving the colon. Furthermore, the investigators hypothesize this will~     reduce morbidity and mortality compared to total abdominal colectomy.~   "
162316|NCT01441258|"~     Harley and colleagues demonstrated that adding Dialectical Behavior Therapy (DBT)~     skills-groups and therapist consultation to treatment as usual successfully reduced symptoms~     of depression. The present study will expand upon these findings. Second, DBT is not known~     for reducing suicidal ideation (SI), a major risk factor for suicide . The present study will~     tailor the aforementioned skills-groups to specifically target suicidal thoughts and~     behaviors through Cognitive Behavior Therapy (CBT) strategies aimed at increasing~     problem-solving deficits, hopelessness, and negativistic thinking. Third, the present study~     will extend this DBT-based approach to a novel population. Fourth, the present study is the~     first DBT intervention to employ state-of-the-art multi-method measurement (including~     objective assessment) of suicidal thoughts and behaviors.~      The investigators hypothesize that participants in the DBT skills (DBT-S) group will show~     improvements in level of suicidality as measured by decreased scores on the Beck Scale for~     Suicide Ideation as compared with participants in the Wait List-Treatment as Usual (WL-TAU)~     group.~   "
162317|NCT01441245|"~     Intravenous loop diuretics is the therapy most commonly used to treat pulmonary congestion~     and systemic fluid overload. In theory, continuous infusion should allow for a more~     consistent diuresis, avoiding the sodium reabsorption in the distal tubule as well as the~     neurohormonal activation. This should lead to renal function improvement and BNP decrease.~   "
162318|NCT01441232|"~     This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211~     when administered concurrently with sitagliptin (Januvia®) in patients with Type 2 Diabetes~     Mellitus.~   "
162380|NCT01440413|"~     This is a prospective, non-randomized study which aims to evaluate the response to a~     neoadjuvant chemotherapy according to the the antitumor immune response in localized breast~     cancer.~      40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4~     anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles.~      Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated~     and receive an adjuvant treatment which will both depend on the investigator's appreciation.~      Blood sample will be collected on the first day of the first chemotherapy cycle, on the first~     day of the third cycle, on surgery, 6 months after the surgery and in case of relapse.~      Tumor sample will be collected on diagnosis as much as possible and on surgery.~      Patients will be followed during 5 years.~   "
162319|NCT01441219|"~     Obscure gastrointestinal bleeding (OGIB) has been one of the most challenging area in the~     field of gastroenterology, as small bowel is beyond the reach of ordinary endoscopes like~     oesophagogastroduodenoscopy (OGD) and colonoscopy. Thanks for the latest technological~     advancement for investigating small intestine, we are now capable of obtaining intraluminal~     images safely through capsule endoscopy (CE). Its role in obscure gastrointestinal bleeding,~     Crohn's disease and other small bowel pathologies has already been proven, and nowadays it is~     suggested by various authorities to be the first-line modality among all small bowel~     investigations.~      The investigators group has showed that CE can alter the clinical management of patients with~     OGIB - patients with negative CE has lower rebleeding rate, and therefore we may adopt a~     conservative approach for them. Although supported by some other group as well, conflicting~     results were still reported in the literature about the out-come of these patients. The main~     criticisms for these studies are that, CE can only identify 61% of the underlying small bowel~     bleeding pathology, and one can never ascertain the outcome of patients with negative CE~     examination. Apparently there is still room for improvement in the current CE technology.~   "
162320|NCT01441206|"~     The purpose of this study is to learn more about the safety and dosing of rifampin in~     infants.~   "
162321|NCT01441193|"~     This Phase I study was directed at evaluating the safety profile and the immunogenicity of~     the vaccination with recombinant HIV-1 Tat and V2-deleted Env (delta-V2 Env) proteins~     administered in association in healthy, immunologically competent adults, compared to~     delta-V2 Env or Tat alone.~   "
162322|NCT01441180|"~     Background:~      - GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by~     blocking the hepatitis C virus from dividing in the body. This medication has been used along~     with other medications commonly used to treat hepatitis C, such as interferon and ribavirin.~     When used with interferon and ribavirin, GS-7977 seems to be very effective in eliminating~     the hepatitis C virus from the body. However, interferon can have serious side effects, so~     researchers want to see if GS-7977 can work by itself or with only ribavirin.~      Objectives:~      - To test the safety and effectiveness of GS-7977 alone or given with ribavirin for hepatitis~     C infection.~      Eligibility:~      - Individuals at least 18 years of age who have hepatitis C with liver disease, and have~     never received drugs for it.~      Design:~        -  This study will require multiple clinic visits over 18 months. A liver biopsy will be~          required before the start of the study if participants have not had one within the past~          3 years.~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken~          by mouth once a day. Ribavirin is taken by mouth in the morning and evening.~        -  Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will~          involve regular blood tests and symptom monitoring.~        -  After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12,~          16, and 20. Blood and urine tests will be given to study virus levels in the body, and~          symptoms will be discussed.~        -  Participants will stop receiving the study drugs at Week 24.~        -  Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60, and~          72. Another liver biopsy will be performed at 48 weeks.~        -  Some participants may also be part of a smaller study. This study involves frequent~          blood draws to study drug and virus levels in the blood. The study will require a~          36-hour hospital inpatient visit.~   "
162323|NCT01441167|"~     Background:~        -  Malaria parasites are carried by mosquitoes, which spread the infection by biting~          people. Currently, there is no effective malaria vaccine. However, studies show that~          volunteers bitten many times by mosquitoes that carry weakened malaria parasites could~          fight off getting sick with malaria when later exposed to normal malaria parasites.~          Malaria parasites are weakened by exposing them to radiation when they are in the stage~          of development called sporozoites . Only the mosquitoes are irradiated and study~          volunteers are not exposed to radiation. The radiation stops the parasites from being~          able to cause disease but still promote protection. For many years, it was not possible~          to give these sporozoites to people as a vaccine since they could not be adequately~          purified from the mosquito. Scientists have recently figured out how to produce and~          isolate the weakened sporozoites so that they can be given in an injected vaccine. This~          vaccine is known as the PfSPZ vaccine.~        -  A malaria challenge will be used to test whether the vaccine will prevent infection. In~          a malaria challenge, mosquitoes that have the malaria parasite will be allowed to bite a~          participant's arm. In the event that the vaccine does not work, the malaria parasite~          used for the challenge can be treated completely with common anti-malaria medications.~          Participants will be treated immediately if they develop malaria symptoms.~      Objectives:~      - To test the safety and effectiveness of the PfSPZ vaccine.~      Eligibility:~      - Healthy volunteers between 18 to 45 years of age.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~          There will be five different groups of study participants, all of whom will be monitored~          with frequent blood tests.~        -  Group 1 will have two vaccines with the lowest amount of the vaccine given 4 weeks~          apart, with regular clinic visits up to 24 weeks after the second vaccine. This group~          will not have a malaria challenge.~        -  Group 2 will have four or six vaccines given 4 weeks apart at a higher dose than group~          1. A malaria challenge will be given about 3 weeks after the last vaccine. Follow-up~          visits will continue through 24 weeks after the last vaccine.~        -  Group 3 will have four or six vaccines given 4 weeks apart at a higher dose than group~          2. A malaria challenge will be given about 3 weeks after the last vaccination, as for~          Group 2. Follow-up visits will continue through 24 weeks after last vaccine.~        -  Group 4 will have four or six vaccines given 4 weeks apart at a higher dose than group~          3. A malaria challenge will be given about 3 weeks after the last vaccination. Follow up~          visits will continue through 24 weeks after last vaccine.~        -  Group 5 will serve as a control group and will not receive the vaccine, but will have~          the malaria challenge. Follow-up visits will continue through 8 weeks after the~          challenge.~      All participants from any group who receive a malaria challenge will be treated promptly for~     malaria when it develops.~   "
162324|NCT01441154|"~     Background:~      - Thyroid hormone is produced by the thyroid gland, an organ at the base of the neck. Thyroid~     hormone controls the body's metabolism and the function of many organs. The thyroid gland~     produces two forms of thyroid hormone: T4 and T3. People who have thyroid cancer are treated~     with thyroid hormone therapy (synthetic T4, levothyroxine), which at times needs to be~     stopped to allow for cancer treatments. At these times, a different form of thyroid hormone~     (synthetic T3, liothyronine) is used to reduce the symptoms caused by low levels of thyroid~     hormone. Researchers want to know more about how changes in T3 hormone affect the body and~     organ function.~      Objectives:~      - To study how changes in T3 hormone levels affect the body and organ function.~      Eligibility:~      - Individuals at least 18 years of age who have had most or all of their thyroid removed to~     treat thyroid cancer who need to stop taking their regular thyroid hormone dose in~     preparation for the treatment of thyroid cancer.~      Design:~        -  The study involves a screening visit and a baseline evaluation. It also includes an~          11-day inpatient hospital stay.~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and a neck ultrasound.~        -  Participants will be evaluated with a physical exam, blood tests, and the following~          procedures:~        -  Glucose tolerance test to measure blood sugar~        -  Tests of body fat, muscle strength, and calorie burning levels~        -  Imaging studies of the heart, liver, and thigh muscles~        -  Quality of life questionnaires~        -  Food preference and diet questionnaires~        -  After 4 weeks of treatment with T3 hormone, participants will have an 11-day inpatient~          hospital stay to study the effect of thyroid hormone on their metabolism. The stay will~          involve the same tests done in the baseline evaluation.~   "
162325|NCT01441141|"~     Background:~      - Pain is the most common symptom of sickle cell disease. Episodes of severe sickle cell pain~     are known as crises. High rates of pain crises are associated with a higher risk of early~     death. Some people with sickle cell disease have many severe pain crises while others~     experience fewer crises. This difference in pain crisis may be caused by sensitivity to pain.~     People with high sensitivity to pain may have more pain crises. Many factors, including a~     person's genetic makeup, determine sensitivity to pain. Comparing genetic information from~     people with sickle cell disease and healthy volunteers may provide more information on pain~     and sickle cell disease.~      Objectives:~      - To study genetics and pain sensitivity in sickle cell disease.~      Eligibility:~        -  African or African American individuals at least 18 years of age with sickle cell~          disease.~        -  Healthy African or African American volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          provide blood and urine samples.~        -  Participants will have the following tests:~        -  Quantitative sensory testing to measure sensitivity to pressure, heat, cold, and~          mechanical pain.~        -  EndoPat test to measure blood vessel function and reaction.~        -  Questionnaires about mood, evidence of depression, pain, quality of sleep, and sleep~          disturbances.~        -  Measures of daily pain, whether or not related to sickle cell disease.~        -  After the first visit, those in the study will have monthly study visits for 6 months.~          The above tests will be repeated at these visits.~   "
162326|NCT01441128|"~     Background:~      - PF-02341066 and PF-00299804 are drugs that specifically target certain proteins that may be~     more active in cancer cells than normal cells, in particular in non-small cell lung cancer.~     Both drugs seem to be able to stop the growth of or kill cancer cells. Researchers want to~     combine them to see if they are a safe and effective treatment for advanced non-small cell~     lung cancer.~      Objectives:~      - To test the safety and effectiveness of PF-02341066 and PF-00299804 for advanced non-small~     cell lung cancer.~      Eligibility:~      - Individuals at least 18 years of age with advanced non-small cell lung cancer that has not~     responded to standard treatments.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, and imaging studies. Heart and lung function tests and an~          eye exam may also be given.~        -  The first cycle of treatment will be 28 days. Every cycle after the first will be 21~          days. Participants may have up to 17 cycles of treatment.~        -  Participants will take both study drugs as tablets. Twelve hours after the first dose,~          participants will take only the PF-02341066. This dose schedule will remain the same~          throughout the study.~        -  Participants will be monitored with frequent blood and urine tests and imaging studies.~          Tumor biopsies will be taken as needed. Those in the study will keep a diary to record~          any symptoms or side effects of taking the study drugs.~        -  After 17 cycles of treatment, or after stopping the study drugs early for any other~          reason, participants will have a final followup visit.~   "
162327|NCT01441115|"~     Background:~      - ECI301 is a drug that may help make cancer cells more visible to the immune system after~     radiation. The drug may also help the immune system destroy the cancer at sites that have not~     received radiation therapy. Researchers want to study ECI301 in people with advanced cancer~     or cancer that has spread in the body (metastatic).~      Objectives:~      - To test ECI301 with radiation therapy for advanced or metastatic cancer.~      Eligibility:~      - People at least 18 years of age with either metastatic or advanced cancer that may benefit~     from radiation therapy.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, and imaging studies.~        -  All participants will have radiation therapy 5 days a week for 2 weeks.~        -  They will have different doses of ECI301 to test its safety and effectiveness. ECI301~          will be given in a vein during the second week of radiation therapy. Frequent blood~          tests and imaging studies will monitor the treatment.~        -  After participants have ECI301, tumor samples may be taken from the site that had~          radiation and another site that did not have radiation.~        -  Followup visits will include blood tests and imaging studies.~   "
162328|NCT01441102|"~     Background: Many people with diabetes have macular edema (swelling) at the back of the eye.~     Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in~     the swelling. A drug called dextromethorphan may help prevent the inflammation and the~     swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been~     studied to see if it can help in diabetic macular edema.~      Objectives: To see if dextromethorphan can help treat diabetic macular edema.~      Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least~     one eye.~      Design:~        -  This study lasts 2 years, and will require at least 14 visits to the National Eye~          Institute outpatient clinic. Study visits will be every month for the first 2 months and~          then every other month. Each visit will take about 2 to 4 hours.~        -  Participants will be screened with a physical exam, medical history, eye exam, and blood~          tests. One eye with macular edema will be chosen as the study eye for testing.~        -  Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years.~          A study diary will help keep track of the date, time, and number of pills taken.~        -  Participants will have study visits once a month for the first 2 months and then every~          other month for the rest of the study. Each study visit will involve eye exams and blood~          and urine tests.~        -  Four months after starting the study medication, participants may have laser surgery or~          other treatments for the macular edema, if it is needed.~   "
162329|NCT01441089|"~     Background:~      - Some genes may be associated with a greater chance of side effects during cancer treatment.~     These genes may also make certain treatments less effective. Researchers want to collect~     blood or cheek swab samples from people having cancer treatment to study these genes.~      Objectives:~      - To obtain a blood or cheek swab sample to study genetic differences that may affect cancer~     treatment.~      Eligibility:~      - Individuals with cancer who are being treated at the National Cancer Institute.~      Design:~        -  Participants will provide a blood sample for study.~        -  Participants who have blood-based cancer, such as leukemia, will provide a cheek swab~          sample.~        -  If the blood or cheek swab sample does not have enough genetic material for analysis, an~          additional sample may be collected.~   "
162330|NCT01441076|"~     Background:~      - Behcet's disease (BD) is an autoimmune disease where the immune system attacks the body.~     People with BD may develop oral or genital ulcers, skin problems, and eye disease. Most drugs~     used to treat BD suppress the immune system, but they are not always helpful and may have~     side effects. A new drug, anakinra, may be able to treat BD with fewer side effects. Because~     it has not been studied in people with BD, anakinra is considered an experimental treatment.~      Objectives:~      - To test whether anakinra can be a safe and effective treatment for Behcet s disease.~      Eligibility:~      - People who have Behcet's disease with ongoing oral or genital ulcers for at least one~     month, or three or more flares of eye disease in the past 6 months.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests. They will be divided into two groups: those with oral or~          genital ulcers and those with eye disease.~        -  All participants will keep a diary of symptoms for a month before starting the study~          drug.~        -  Participants with oral or genital ulcers will receive daily injections of anakinra for 3~          to 6 months. Treatment will be monitored with frequent blood draws and daily diaries.~          Those who improve but do not have a full response to the drug may receive a higher dose.~          Those who improve after 6 months may have an extra 6 months on either anakinra or~          placebo to study the differences in response.~        -  Participants with eye disease will receive anakinra for up to 12 months. Treatment will~          be monitored with frequent blood draws, daily diaries, and regular eye exams.~        -  All participants will have a final study visit 1 month after stopping the study drug.~   "
162331|NCT01441063|"~     Background:~      - KSHV-associated multicentric Castleman disease (KSHV-MCD) is caused by a herpes virus known~     as KSHV. This disease can also cause several other cancers, including Kaposi sarcoma. People~     with KSHV-MCD often have symptoms like fever, weight and muscle loss, and fluid in the legs~     or abdomen. Tocilizumab may be able to block the chemicals in the body that cause KSHV-MCD~     symptoms. Researchers want to test this drug and other anti-virus drugs to find the best~     combination of drugs to treat KSHV-MCD.~      Objectives:~      - To test the effectiveness of tocilizumab with and without other anti-virus drugs for~     KSHV-MCD.~      Eligibility:~      - People at least 18 years of age who have KSHV-MCD and have certain symptoms and blood~     abnormalities caused by their KSHV-MCD.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests, and a skin biopsy.~        -  Participants will have tocilizumab injections every 2 weeks for up to 12 weeks. They~          will provide daily blood samples for the first 3 days of treatment.~        -  After the sixth dose, participants will be monitored for 4 weeks to check for possible~          side effects.~        -  Those whose KSHV-MCD does not improve or worsens during the study may have tocilizumab~          combined with two other anti-virus drugs, zidovudine and valganciclovir. These drugs are~          pills that will be taken four times a day for 5 days out of every 2 weeks.~        -  Blood, urine, and saliva samples will be collected throughout the study.~   "
162332|NCT01441037|"~     Background:~      - Some people have bone marrow and lung disorders that are caused by genetic problems. These~     problems often involve damage to the ends of the chromosomes that pass down genes. One of~     these disorders is aplastic anemia. This is a disorder in which the bone marrow does not make~     enough blood cells. Currently, doctors use a male hormone-based drug called Danazol to~     improve bone marrow function and treat aplastic anemia. More information is needed on whether~     Danazol can help repair the damaged chromosomes that cause aplastic anemia and similar~     disorders that cause low blood cell counts or lung problems.~      Objectives:~      - To study the safety and effectiveness of Danazol for bone marrow and lung disorders caused~     by damaged genes.~      Eligibility:~      - Individuals at least 2 years of age who have low blood cell counts or lung fibrosis caused~     by damaged genes.~      Design:~        -  Participants will be screened with a physical exam and medical history. Then they will~          have blood and urine tests, imaging studies, and a lung function test. They will also~          take a 6-minute walking test and have a bone marrow biopsy.~        -  Participants will receive Danazol to take twice a day for the duration of the study.~        -  Participants will have regular study visits at 6, 12, and 24 months, with blood tests,~          imaging studies, a lung function test, and a 6-minute walking test. A bone marrow sample~          will be collected at the 12-month visit.~        -  Participants will remain on the study for up to 2 years. Researchers will follow up with~          them for 2 years after the end of the study.~   "
162333|NCT01441024|"~     Background:~      - Parainfluenza is a virus that can cause infections in people. Most people infected with~     this virus have mild symptoms including fever, cough, red eyes, or runny nose (a common~     cold). Some people, especially those with a weakened immune system, get very sick from this~     virus. They may have difficulty breathing or develop lung infections. Currently, there are no~     specific treatments for parainfluenza. However, a drug called DAS181 may make the virus go~     away faster. Researchers are interested in testing DAS181 to see if it is safe and effective~     against parainfluenza.~      Objectives:~      - To test the safety and effectiveness of DAS181 as a treatment for parainfluenza.~      Eligibility:~      - Individuals at least 18 years of age who have the parainfluenza virus and have developed~     symptoms within the past 10 days.~      Design:~        -  Participants will be screened with a physical exam, medical history, and questions about~          symptoms and activity levels. Participants will also have a lung function test and~          provide blood and nasal fluid samples.~        -  DAS181 is an inhaled medication, and everyone will receive a study medication inhaler.~          Participants will receive either DAS181 or a placebo through the inhaler. They will take~          it once every day for 5 days.~        -  Participants will have monitoring visits on days 2, 4, 7, 10, 14, and 28 to provide~          blood and nasal fluid samples and have a lung function test.~        -  Participants who still have the virus in their system on Day 28 will return to the~          clinic on Day 42 for more tests. Participants who still have the virus in their system~          on Day 42 will return to the clinic on Day 56 for more tests.~        -  Participants will have followup visits 6 months and 1 year after the start of the study.~   "
162334|NCT01441011|"~     Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence~     and death compared to their normal weight counterparts. Moreover, weight gain and decreased~     physical activity are common after diagnosis and also increase the likelihood of breast~     cancer recurrence and death. Rural women suffer from health disparities in breast cancer~     diagnosis and treatment. Women of the most rural counties also have the highest prevalence of~     obesity compared to urban women. To address these disparities, the overarching objective of~     this proposal is to develop a clinically effective and cost efficient strategy for delivering~     a weight control intervention to rural breast cancer survivors. Group phone-based treatment~     via conference call is a novel treatment delivery approach that the investigators have shown~     to be effective for initial weight loss among rural breast cancer survivors and more~     effective than the standard individual phone-based approach among rural women. This~     innovative method of providing group treatment addresses access barriers in rural areas and~     may be especially ideal for rural breast cancer survivors because it provides social support~     in conjunction with a level of anonymity. However, the impact of group phone counseling~     during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss~     maintenance is the more challenging phase of treatment when weight regain is common, and this~     regain presents a potential risk for breast cancer recurrence. This randomized controlled~     trial will evaluate the effects of group phone-based treatment for weight loss maintenance~     among rural breast cancer survivors, compared to an established mail-based education~     comparison condition, subsequent to a 6 month group phone-based weight loss phase for both~     conditions. In addition to the intervention impact on weight loss maintenance, the study will~     provide estimates of incremental cost-effectiveness per kg loss between the two conditions~     and the impact on secondary outcomes including quality of life, breast cancer risk~     biomarkers, dietary intake, and physical activity.~   "
162335|NCT01440998|"~     This pilot phase I trial studies how well dasatinib works together with paclitaxel and~     carboplatin in treating patients with stage III, stage IV, or endometrial cancer that has~     come back after a period of improvement. Dasatinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving dasatinib together with paclitaxel and carboplatin may kill more tumor cells.~   "
162336|NCT01440985|"~     Participants will be smokers who want to quit, and have visible nicotine stains on their~     teeth. They will be given toothpaste and a toothbrush to use during the study, and will have~     an equal chance of being assigned to use either a nicotine gum or microtab. They will visit~     the study site five times during the 12 week trial to have their teeth examined.~   "
162337|NCT01440972|"~     The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance~     training program with concurrent application of partial blood flow restriction (PBFR) to the~     exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in~     women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be~     change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators~     will test the following hypotheses. In comparison with low-intensity resistance training~     without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:~      Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee~     extensor strength~      Secondary Hypotheses:~        1. Increase quadriceps muscle volume assessed by MRI~        2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed~          stair climb~        3. Not adversely effect knee pain or quality of life assessed by the Knee injury and~          Osteoarthritis Outcome Score (KOOS) questionnaire~   "
162338|NCT01440959|"~     With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib~     (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients~     with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib~     (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure with~     imatinib. However, virtually all patients will eventually progress or become intolerable~     after the first-line imatinib and the second-line sunitinib. Dovitinib (TKI258, Novartis) is~     a multi-kinase inhibitor. TKI258 is a potent inhibitor of the VEGFR 1, 2, and 3, FGFR1, 2 and~     3, PDGFRβ, Kit, RET, TrkA, CSF 1R, and FLT3 with inhibitory concentration 50% (IC50s) of less~     than 40nM. Stem cell factor (SCF) also termed KIT ligand, or steel factor has been shown to~     modulate tumor angiogenesis. In cultured human endothelial cells and Kit expressing cancer~     cells, TKI258 inhibits VEGF- and SCF-stimulated mitogenesis. .~   "
162339|NCT01440946|"~     The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation~     Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia~     B. Secondary objectives of this study in this study population are as follows: to evaluate~     the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and~     assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and~     treatment of bleeding episodes~   "
162340|NCT01440933|"~     Sugammadex is a new reversal agent for neuromuscular blockers (curare). It encapsulates the~     curare molecule and terminates immediately its action. The recommended dose is 2 mg/kg for a~     slight neuromuscular block and 4 mg/kg for a profound neuromuscular block. Magnesium sulphate~     is frequently used in perioperative medicine and it is known to reinforce the neuromuscular~     block induced for instance by rocuronium. The researchers want to investigate, whether higher~     doses of sugammadex must be given to antagonize the neuromuscular block induced by rocuronium~     in patients who received magnesium sulphate.~   "
162341|NCT01440920|"~     The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with~     acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who~     completed a standard consolidation therapy.~   "
162342|NCT01440907|"~     The purpose of this research study is to evaluate the effect of a health information exchange~     (HIE)-supported care coordination package on 30-day readmission rates in a frail elderly~     population.~   "
162343|NCT01440894|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the functions and efficiency of devices.~        2. Test methods and procedures: Comparison Test.~        3. DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012,~          BF-1039, BF-1041-A, and GBF-950-D.~        4. Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device).~        5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Efficiencies of Transtek devices and predicate device are in the same level.~   "
162344|NCT01440881|"~     This project evaluates whether nesiritide, human recombinant brain natriuretic peptide,~     confers renal protection during cardiovascular surgery by attenuating the inflammatory~     response.~   "
162345|NCT01440868|"~     BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the~     efficacy of the respiratory effort in lung of preterm infants at risk for respiratory~     distress syndrome (RDS) and reduce need of mechanical ventilation (MV).~      The investigators aim will be to demonstrate the hypothesis that the introduction of SLI in~     the delivery room protocol may reduce the need of MV in preterm infants.~      STUDY DESIGN: Multicenter prospective randomized controlled trial. The study will be carried~     out at the neonatal care units of the Careggi Infants with a gestational age between 25 and~     28 weeks will be eligible and randomized at birth to receive SLI or not. Peak inflation~     pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a positive~     end expiratory pressure (PEEP) of 5 cm H2O.~      Primary endpoint will be the need of MV within the first 72 hrs of life (excluding the~     transient tracheal intubation for surfactant replacement: e.g. INSURE). Population size:~     hypothesizing that SLI maneuver might decrease the need of MV during the first 72 hours of~     life from 35 to 20% the investigators calculated that 138 newborns must be enrolled in each~     groups to detect this difference statistically significant with 80% power at 0.05 level.~   "
162346|NCT01440855|"~     This study was designed to provide a preliminary evaluation of the efficacy and usability of~     the 2004 revised version of the booklet, Facing Forward , Life After Cancer Treatment,~     (hereafter,Facing Forward) published by the National Cancer Institute. Facing Forward~     provides early stage cancer patients during the period after completing active treatment~     practical ways of dealing with common problems, including guidelines for managing physical,~     social, and emotional health. Assessments were completed at the patient's final cancer~     treatment visit. Follow-up assessments occurred eight weeks and 6 months later. The initial~     assessments covered background information (demographics, medical status), use of educational~     materials, survivorship activities, and psychological factors. The follow-up assessments~     included use of actions recommended in Facing Forward, ratings of Facing Forward with respect~     the booklet's informativeness, helpfulness, understandability, and extent read, the same~     psychological measures used initially, and a measure of self-efficacy.~   "
162347|NCT01440842|"~     The purpose of this study is to assess the efficacy, safety and feasibility of a~     computer-based control algorithm to control glucose levels in adults in intensive care unit,~     in comparison to standard care.~   "
162350|NCT01440803|"~     Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise~     completely healthy individuals with no secondary cause of bone loss. In the course of our~     prior research with premenopausal women with IOP, the investigators have shown that women~     with IOP have low areal bone mineral density (aBMD) at the spine, hip and forearm compared to~     normal women. Additionally, using noninvasive high resolution imaging of the central and~     peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the~     investigators identified several features of bone quality in premenopausal women with IOP.~      There is currently no FDA-approved therapy for IOP in premenopausal women. However,~     teriparatide (Forteo) has been shown to improve bone mass and microarchitecture in~     postmenopausal women and is approved for men with primary or idiopathic osteoporosis, as well~     as men, premenopausal and postmenopausal women with glucocorticoid-induced osteoporosis.~     Because IOP in premenopausal women is an orphan disease, with an estimated prevalence of~     about 113,000 in the United States, pharmaceutical companies are unlikely to support~     development of therapies for this indication. Therefore, the major objective of this protocol~     is to establish the safety and efficacy of teriparatide in premenopausal women with IOP in a~     phase 2 clinical trial. All subjects will receive teriparatide as part of the study, but a~     randomly selected group of patients (10) will receive one year of placebo injections first~     before starting their two years of treatment. The remainder of subjects (30) will receive~     active drug only for two years.~      Funding Source - FDA OOPD~   "
162351|NCT01440790|"~     The objective of this study is to determine the effect of reducing the rate of glucose~     absorption on oxidative stress after eating and to compare it with the effects of vitamin C.~     The hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress~     to a similar extent as 1g vitamin C.~   "
162352|NCT01440777|"~     This research will examine the effectiveness of a 6-week online sleep program (Go! To Sleep)~     which provides a set of various psycho-educational materials and behavioral techniques to~     reduce insomnia symptoms, improve sleep, and improve quality of life.~   "
162353|NCT01440764|"~     The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide, a~     treatment that has the potential to significantly improve symptom management and enhance the~     quality of care for patients with intractable dyspnea.~   "
162354|NCT01440751|"~     The objective of this prospective randomised study is to compare the efficacy and safety of~     ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in~     uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety~     being the secondary.~   "
162355|NCT01440738|"~     Objectives~      Main objective: Assessing the effectiveness of the health workshops, in terms of quality of~     life.~      Secondary: To determine the effectiveness of the health workshops in relation to: Increase~     knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced~     diet. Incorporate and maintain regular physical activity; Keep variables related to risk~     factors (BP, Weight, Cholesterol) within normal limits, reduce cardiovascular risk (RCV). To~     estimate costs.~      Methodology~      Design: randomized controlled trial comparing a group of patients who performed the health~     workshops with a control group with similar characteristics.~      Scope of the Study: The study was conducted in 54 health centers of Barcelona city.~      Subjects of study: general population between 18 and 65 years who consent to. 188 people with~     speech (have conducted workshops for health) and 188 people without (not made health~     workshops. Data Analysis: T- test to compare the differences between quantitative variables~     or equivalent non-parametric if the distribution of the variable does not meet criteria of~     normality (Kolmogorov-Smirnov).~   "
162356|NCT01440725|"~     This is a multicenter, simple blind, masking of outcomes assessors, parallel, randomised~     clinical trial in patient with muscle rupture and with hematoma production. The main~     hypothesis is that infiltration in the area of muscle injury in autologous platelet-rich~     plasma (PRP)improves muscle regeneration and repair by shortening the time to complete~     recovery.~      The main objective is to evaluate the PRP for healing muscular lesions 'tennis leg' type or~     distal rectus femoral. The secondary objectives are: to evaluate the risk of lesion~     recurrence; to evaluate the quality of lesion recovery process and evaluate intervention's~     safety.~      Experimental treatment will be the administration of PRP autologous (4-8 cc in a unique dose)~     by muscular infiltration en the empty space generated after the hematoma evacuation. Control~     treatment will be hematoma evacuation. Both treatment groups will use compressive bandage and~     they will recommend rest, extremity elevation, local ice and lately physiotherapy.~      Size sample: 76 patients (38 in each group)~   "
162357|NCT01440712|"~     The purpose of this trial is to determine whether the water-soluble contrast (gastrografin)~     is more effective in the treatment of postoperative ileus than the conventional one.~   "
162358|NCT01440699|"~     Adipose-derived stem cells have properties of differentiation to various types of cells,~     immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.~      Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in~     Phase I and II study on the patients with Crohn's fistula.~      However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing~     ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and~     efficacy in patients with Crohn's fistula.~   "
162359|NCT01440686|"~     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of~     HL-032 after oral administration in healthy male volunteers.~   "
162360|NCT01440673|"~     -  Gynecological surgery is associated with a high incidence of postoperative nausea and~          vomiting.~        -  NK1 receptor antagonists such as aprepitant appear to be highly effective for treating~          acute and delayed emesis, and yet understanding of the efficacy of different doses of~          aprepitant is limited.~        -  We performed a prospective, randomized, double-blinded placebo-controlled study of 123~          female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125~          mg aprepitant, or a placebo.~   "
162361|NCT01440660|"~     To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using~     multimodal testing/imaging procedures.~   "
162397|NCT01440192|"~     The primary objective of the study is to assess the safety and tolerability of a single dose~     of PDA001 (given twice) in subjects with Stage II or III Pulmonary Sarcoidosis (PS) who are~     refractory to one or more of the following treatments for PS: methotrexate,immunosuppressants~     or cytotoxic agents.~   "
162362|NCT01440647|"~     Very premature infants often cannot breathe on their own and require assistance with a~     respirator. Conventional respirators deliver air or oxygen via a breathing tube placed~     through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube~     is associated with injury to the lungs. Currently, a premature baby has to be ventilated~     through an endotracheal tube until he/she can fully breathe independently. In the current~     study, in order to shorten the time with an endotracheal tube, we utilized an alternative,~     less invasive ventilation procedure, nasal intermittent positive pressure ventilation~     (NIPPV). This procedure provides help with breathing, but requires only nasal, not~     endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage~     in their recovery, when they could not breathe independently yet. Thus, by switching babies~     at this early stage from a regular respirator to NIPPV, we should be able to shorten the use~     of an injurious endotracheal tube.~   "
162363|NCT01440634|"~     Peripheral Arterial Disease (PAD) is a highly prevalent public health problem that results~     from progressive atherosclerosis of arteries in the lower extremities. PAD is also associated~     with major detrimental effects on quality of life and functional status, and is the most~     important cause of limb amputation. More importantly, PAD is a major manifestation of~     cardiovascular disease and a potent predictor of myocardial infarction, stroke and death.~     Despite its frequent occurrence, little is known about the natural history of PAD in~     Hispanics who represent 12.5% of the United States. Because access to health care is limited~     among Hispanics, CBPR is the ideal process to reach this target population. The goal of the~     proposed study is to evaluate community-based strategies of detection and treatment of~     peripheral arterial disease (PAD) in Hispanics. The proposed project consists of two phases:~     a cross-sectional phase (PAD detection), followed by a randomization phase.During the PAD~     detection study , the prevalence and severity of PAD in this population will be determined.~     Specific risk factors associated with PAD among the Hispanic participants will be identified.~     During the second phase patients will be enrolled in a randomized, non-blinded trial~     comparing a community-based risk factor modification and supervised exercise program versus~     usual care for PAD. These individuals will undergo a baseline evaluation similar to the one~     obtained during the first phase of the study, but will also include functional testing of the~     lower extremities.~   "
162364|NCT01440621|"~     Cancer related fatigue (CRF) is a highly prevalent and highly significant entity among~     patients with cancer. 'Cancer related fatigue' is not a simple symptom, but is an entity in~     itself, in that it is different from routine fatigue. Cancer related fatigue is that fatigue~     which persists even after rest and has significant effects on quality of life.~      The incidence of Cancer Related Fatigue (CRF) increases during radiation therapy (RT), with~     almost every patient on radiotherapy complaining of at-least some magnitude of fatigue.~      Given that fatigue can affect treatment adherence by patients, it is important to initiate~     measures to either prevent or mitigate Cancer Related Fatigue.~      The investigators intend to use modafinil in cancer related fatigue, in view of the fact that~     it has safety and efficacy in other diseases such as narcolepsy, multiple sclerosis and~     fibromyalgia. In addition, there have been a few small trials which have hinted towards~     benefit with the use of modafinil in cancer related fatigue.~      The investigators have chosen a dose of 100mg/day in the morning, to be compared with~     placebo. The study arm and the placebo arm will be stratified with respect to age, sex,~     disease site, baseline performance status.~      Primary outcome would be fatigue, which will be assessed by the use of Brief Fatigue~     Inventory (BFI). Secondary outcomes include Quality of Life, improvements in performance~     status, changes in systolic and diastolic blood pressure, and changes in weight.~   "
162365|NCT01440608|"~     The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc~     therapy and de-worming albendazole as separate interventions in restoring normal gut~     absorptive and immunological function as measured by the dual sugar permeability test and~     additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental~     Enteropathy.~   "
162366|NCT01440595|"~     This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir~     (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin~     (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3)~     hepatitis C virus (HCV) infections.~   "
162367|NCT01440582|"~     The goal of this clinical research study is to find the highest tolerable dose of the drug~     panobinostat that can be given in combination with the drugs Velcade (bortezomib), Revlimid~     (lenalidomide), and Decadron (dexamethasone) to patients with MM. The safety of this drug~     combination will also be studied.~      Panobinostat is designed to cause chemical changes in different groups of proteins that are~     attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or~     cause the cancer cells to die.~      Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer~     cells to die.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may slow the growth of~     cancer cells.~      Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.~     Dexamethasone is often given to MM patients in combination with other chemotherapy to treat~     cancer.~   "
162368|NCT01440569|"~     This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus~     two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected,~     antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV)~     resistance-associated mutations.~      After the Week 48 Visit, participants will be given the option to participate in an~     open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it~     becomes commercially available, or until Gilead Sciences elects to terminate development of~     cobicistat.~   "
162398|NCT01440179|"~     Primary Objective:~      Participants achieving an Objective Response Rate~      Secondary Objectives:~        -  Response duration~        -  Progression Free Survival~        -  Minimal residual disease~        -  Safety~        -  Pharmacokinetics~   "
162399|NCT01440166|"~     -  To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative~          to placebo in healthy adult volunteers.~        -  To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy~          adult volunteers.~        -  To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult~          volunteers.~   "
162369|NCT01440556|"~     Autologous hematopoietic cell transplantation is currently considered the standard therapy of~     multiple myeloma (MM) for elegible patients. On the contrary, despite new developments in~     transplant procedures and supportive care, allogeneic bone marrow transplantation is less~     commonly used due to high transplant related mortality (TRM).~      No consensus statement about allografting in MM has so far been reached and only a minority~     of patients undergoing allografting are enrolled in prospective clinical trials.~      Moreover, use of unrelated donors is considerably increased over the time and the recent~     activity survey of European Group for Blood and Marrow Transplantation (EBMT) showed that the~     number of allografts from unrelated donor is higher than that one from HLA-identical siblings~     in Europe.~      In order to evaluate trends in allograft from unrelated donors in multiple myeloma patients,~     the investigators plan to conduct a restrospective study through the Italian Bone Marrow~     Transplantation Registry (IBMDR) over a period ranging since 2000 to 2009. Data will be~     collected from the central data management system Promise (Project Manager Internet Server)~     used by EBMT and from IBMDR.~      The aim of the study is to evaluate the role of unrelated donor allograft in multiple myeloma~     over the last decade and hopefully offer recommendations on patient selection. Primary~     endpoints of the study are: a) Overall Survival (OS) from diagnosis and from the allograft b)~     Event-Free-Survival (EFS) from the allograft. Disease response criteria will be defined~     according to the International Uniform Response Criteria for multiple myeloma. Transplant~     related mortality, Graft-Versus-Host-Disease (GVHD), either acute or chronic~     (limited/extensive) will be evaluated as cumulative incidences. Univariate and multivariate~     analysis will be calculated for the transplant-related and patient-related characteristics.~   "
162370|NCT01440543|"~     Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as~     alternative colonoscopy techniques have been documented to decrease patient discomfort during~     and after the procedure.~      This prospective, randomized, single-center trial was designed to evaluate whether the~     combination of water immersion during insertion and CO2 insufflation during withdrawal~     (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other~     colonoscopy methods (Water/Air, CO2/CO2, Air/Air).~   "
162371|NCT01440530|"~     The purpose of this 3 site, 24-week, Comparative Effectiveness Randomized Clinical Trial in~     Primary Care is to compare usual care to an online, multi-media, digital intervention for~     Persons with Type 2 Diabetes to Improve Engagement, Knowledge, and Self-Care.~   "
162372|NCT01440517|"~     The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in~     diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart~     Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and imaged~     with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic~     dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with~     99mTc-maraciclatide.~   "
162373|NCT01440504|"~     The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 +~     association platinum in samples exposed and demonstrate the value of this combination~     compared to the agents used alone.~   "
162374|NCT01440491|"~     The aim of this study was to evaluate the effect of exercises performed under monitoring of~     the physiotherapist and self performed at home by reading the booklet of exercise orientation~     for patients with nonspecific low back pain.~      A prospective and randomized trial was performed in 44 patients. G1 patients received a~     physiotherapist orientation, and G2 patients received the booklet of exercise to self perform~     the exercises. Pain intensity by Visual Analogue Scale (VAS), and quality of life by SF-36~     were measured before.~      Results: Pain intensity was lower in G1 than in G2 after 6 and 12 weeks. Quality of life was~     better in G1.~      The exercises under orientations of the physiotherapist promoted best effect than self~     performed exercises .~   "
162375|NCT01440478|"~     This study is designed to explore the effect of increased and decreased urinary pH on the~     single pharmacokinetic (PK) dose of LY2140023 and its active metabolite LY404039. All~     participants will receive the three treatments in a randomized order.~   "
162376|NCT01440465|"~     The objective of this study was to evaluate the various parameters involved in the occurrence~     of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic~     among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.~   "
162377|NCT01440452|"~     This research is being done to see how different amounts of Functional Electrical Stimulation~     (FES) affect cycling on factors in blood and spinal cord in people with spinal cord~     inflammation.~   "
162378|NCT01440439|"~     Exercise is an important part of a healthy lifestyle, and many people with Type 1 Diabetes~     like to take part in regular sport and exercise. The majority of people with Type 1 Diabetes~     are treated with a basal bolus insulin regimen, with background insulin provided by~     long-acting basal insulin doses, and bolus doses of short-acting insulin used to~     accompany food intake. Evidence shows that the main factor preventing people with diabetes~     from pursuing a more active lifestyle is fear of low blood glucose (hypoglycaemia). A~     previous study has shown that the type of background insulin affects the likelihood of an~     individual suffering hypoglycaemia during exercise and for 2 and a half hours afterwards. The~     aim of this study is to examine this further.~      The two most commonly used long-acting insulins, insulin glargine and insulin detemir, will~     be compared. Previous data suggests that there is a greater likelihood of hypoglycaemia with~     insulin glargine than insulin detemir. Exercise intensity can have an influence on the~     likelihood of hypoglycaemia, and in this previous study exercise intensity was measured using~     heart rate. This study will use a more formal definition of exercise intensity. The~     investigators will study blood glucose during exercise, but also metabolism as measured by~     hormones affecting blood glucose levels as well as markers of fat metabolism. The~     investigators will also use a continuous glucose monitoring system (CGMS) to consider~     hypoglycaemia on thei night following exercise as this is a recognised consequence of~     exercise in type 1 diabetes.~      The null hypothesis to be tested in this study is that there is no difference between the two~     insulins in their effect on blood glucose levels and metabolism during exercise and rates of~     nocturnal hypoglycaemia after exercise.~   "
162379|NCT01440426|"~     This study deals with coverage of multiple denuded roots. The current standard treatment~     requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance~     results. The hypothesis of this trial is that a synthetic collagen matrix (called Mucograft)~     can be used to replace soft tissue taken from the subject. If the collagen matrix will prove~     to be equally as effective as the patient own tissue, it will be possible to avoid a more~     extensive surgery and decrease pain and discomfort.~   "
162420|NCT01439893|"~     This is a multi-center, randomized, double-blind , placebo parallel controlled, standard~     therapy based phase III clinical trial, to evaluate the efficacy of recombinant human~     neuregulin-1 on cardiac remodeling, as well as safety in patients with chronic heart failure.~   "
162381|NCT01440400|"~     The classical method for spinal anesthesia relies on the use of bony landmarks to identify~     the level and point of entry of the spinal needle. Over the years, in experienced hands, this~     method consistently proved to be successful and safe.~      The introduction of ultrasound to guide neuraxial anaesthesia into clinical practice was~     relatively slow compared to peripheral nerve blocks or central venous catheterization. This~     could be due to the technical difficulties posed by the bony structures surrounding the~     spinal cord and its dura that blocks the path of the ultrasound beam. Many anesthetists are~     reluctant to change their conventional landmark technique, particularly with most studies~     showing no change in the success rate between ultrasound guided and the landmark techniques.~      Several studies however showed that the ultrasound guided approach reduces the number of~     attempts to achieve a successful block and reduces the procedure time particularly in obese~     patients and those with technical difficulties.~      In this study the investigators are trying to answer the following question : Is there any~     advantage in using ultrasound to guide spinal anaesthesia in non obese obstetric patients~     with easily palpable bony landmarks?~   "
162382|NCT01440387|"~     The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline~     (GSK) Biologicals' investigational quadrivalent split virion influenza vaccine FLU-Q-QIV in~     adults 18 years of age and older.~   "
162383|NCT01440374|"~     This was a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part~     3: extension), multi-center study to evaluate the effect of eltrombopag in subjects with~     myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) who have thrombocytopenia due~     to bone marrow insufficiency from their underlying disease or prior chemotherapy. This~     objective was assessed by a composite primary endpoint that consists of the following: the~     proportion of ≥Grade 3 hemorrhagic adverse events, or platelet counts <10 Gi/L, or platelet~     transfusions. Patients with MDS or AML and Grade 4 thrombocytopenia due to bone marrow~     insufficiency from their underlying disease or prior chemotherapy were enrolled in the study.~     No low or intermediate-1 risk MDS subjects were enrolled in the study. Subjects must have had~     at least one of the following during the 4 weeks prior to enrolment: platelet count <10 Gi/L,~     platelet transfusion, or symptomatic hemorrhagic event. Supportive standard of care (SOC),~     including hydroxyurea, was allowed as indicated by local practice throughout the study. The~     study had 3 sequential parts. Subjects who were enrolled in Part 1 (open-label) cannot be~     enrolled in Part 2 of the study (randomized, double-blind); however, subjects who completed~     the treatment period for Part 1 or Part 2 (8 and 12 weeks, respectively) continued in Part 3~     (extension) if the investigator determined that the subject was receiving clinical benefit on~     treatment.~   "
162384|NCT01440361|"~     Chronic immune thrombocytopenia (ITP) is a longterm disease in which the blood does not clot~     normally. This is due to a low number of blood cell fragments called platelets. Platelets~     clot to seal small cuts or breaks on blood vessel walls and stop bleeding. Normally the~     immune system makes proteins called antibodies to fight off harmful substances that enter the~     body. In ITP, the immune system produces antibodies that attack and destroy the body's~     platelets by mistake.~      Patients can suffer from bleeding under the skin, nosebleeds, blood in urine or stools and in~     very severe cases bleeding in the brain. Patients have an increased frequency of death from~     bleeding complications compared to normal.~      Chronic ITP is fairly rare , with an incidence of 32 new cases/million people each year.~      Existing treatments work by lowering the activity of the immune system or directly increasing~     platelet count. These treatments do not work effectively in all patients and can have side~     effects. We hope that understanding how belimumab works in ITP will help in the development~     of future treatments for ITP and other autoimmune diseases.~      We will test the safety, blood levels and effects of the study medication in people with~     chronic ITP. Patients will receive the study medication intravenously (through a needle~     inserted into a vein) and blood samples will be taken before and on several occasions~     afterwards.~      Up to 40 patients with chronic ITP, aged 18 to 75 will participate. Approximately 11 patients~     will take dummy medicine instead of the study medicine neither they or their study doctor~     will know which one they are given. Participants will take up to 57 weeks to finish the~     study. They'll make 12 outpatient visits.~      The study will take place in hospitals in the UK. Other sites in mainland Europe may also be~     initiated.~      A pharmaceutical company, GlaxoSmithKline, is funding the study.~   "
162385|NCT01440348|"~     This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a~     single free tendon Achilles allograft using new technique.~   "
162386|NCT01440335|"~     Background:~      - Fenoterol has been used to treat asthma by opening up the airways in the lungs. It also~     increases the heart rate without significantly increasing blood pressure. This means that it~     may help improve heart function by boosting the heart's output. Researchers have developed a~     different form of the drug that may be given to individuals with heart trouble. This new form~     needs more testing. It is especially important to compare the new form with the original form~     of the drug used to treat asthma.~      Objectives:~      - To compare how safe and effective two different forms of Fenoterol are in improving heart~     function.~      Eligibility:~      - Healthy people between 21 and 60 years of age who have no history of heart disease.~      Design:~        -  People will be screened with a medical history, physical exam, blood and urine tests,~          and heart function studies.~        -  Those in the study will have two 36-hour inpatient study visits. At each visit, they~          will have a physical exam and blood and urine tests. They will fast overnight and then~          receive one of the two forms of Fenoterol first thing in the morning. They will not know~          whether they are getting the original or the modified form of the drug. After receiving~          the drug, they will provide frequent blood and urine samples for 24 hours. They will~          have a final exam before being discharged.~        -  Those who take part in the study will have a followup visit 5 to 7 days after the end of~          each study visit. They will provide more blood and urine samples and have a physical~          exam.~   "
162387|NCT01440322|"~     The purpose of this study was to evaluate the subjective and objective performance and the~     physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA~     contact lenses in participants with normal eyes and prescription needs.~   "
162388|NCT01440309|"~     The study is designed to evaluate the safety and efficacy of intravenous administration of~     bone marrow derived mesenchymal stem cells for patients with refractory primary biliary~     cirrhosis (PBC).~   "
162421|NCT01439880|"~     The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be~     safe and well tolerated in subjects with hypercholesterolemia.~   "
162422|NCT01439867|"~     The primary objective was to characterize corrected serum calcium levels on treatment with~     cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).~   "
164143|NCT01417299|"~     The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201~     has been reported to induce neuronal regeneration in animal models. Evaluation will be done~     by combining clinical /behavioral assessment with fMRI studies.~   "
162389|NCT01440296|"~     The Canadian Atherosclerosis Imaging Network (CAIN) is a pan-canadian imaging network funded~     through grants from the Canadian Foundation for Innovation (CFI) and the Canadian Institutes~     of Health Research (CIHR). This unique research network is focused on the pathobiology of~     atherosclerotic disease as it pertains to the coronary and carotid circulations. The CAIN~     research program involves the creation of a unique national network focused on in vivo~     imaging of vessel wall disease, combined with imaging of occult end-organ disease as well as~     the acquisition of clinical and pathological end points. CAIN enables unprecedented~     cross-sectional and longitudinal clinical studies of patients with atherosclerotic disease in~     coronary or carotid vascular beds, and has established an international resource for studying~     the natural history, progression, regression and novel therapeutic interventions aimed at~     atherosclerosis.~      The primary outcome of this study is to accurately characterise carotid plaque morphology in~     non-surgical patients with mild to severe (30-95%) carotid disease. The investigators will~     also assess evidence of ischaemic brain disease. Patients will undergo MRI scanning of the~     brain and carotid and US scanning of the carotid at baseline and thereafter at 1 and 2 years~     or sooner if presenting clinically in order to monitor the natural history of carotid~     atherosclerosis and its effect on end-organ brain disease.~      Patients will consent to baseline scanning and follow up at 1 and 2 years, and databasing of~     clinical and imaging data. After each imaging session images will be processed, stored~     locally and also sent to a central repository. 500 patients will be recruited over a 2 year~     period in anticipation of study completion within 4 years.~   "
162390|NCT01440283|"~     High risk neuroblastoma (NB) is an aggressive, prevalent non-brain cancer derived from nerve~     cells of the body. It mostly affects infants, and more children die from this tumor each year~     than are cured. Standard therapy includes a combination of chemotherapy, surgery, bone marrow~     transplant, radiation and immunotherapy. NB is very sensitive to radiation, but due to it's~     aggressive spread pattern, radiation use is currently limited by toxicity. This study seeks~     to improve delivery of radiation to reduce toxicity by quantifying outcomes, and measuring~     differences in renal toxicity and organ motion so that radiation can be focused more~     effectively against tumor while sparing normal tissues and reducing side-effects.~   "
162391|NCT01440270|"~     Epidermal growth factor receptor（EGFR） is a potential target for new anticancer therapy in~     head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody~     results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell~     proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The~     study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and~     radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on~     prognosis. The endpoints of this study are the pathological complete response after~     neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival~     rate, and the safety.~   "
162392|NCT01440257|"~     The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary~     albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to~     study the safety and efficacy of the medication in this patient population.~   "
162393|NCT01440244|"~     Although thoracic NOTES may not be ready for human trials, a new minimally invasive technique~     to access the pleural cavity and perform pleural, pulmonary and mediastinal procedures would~     be possible. Cervical Video Assisted Thoracoscopic Surgery (C-VATS) is a technique that~     borrows from traditional VATS procedures, from cervical mediastinoscopy, and from flexible~     endoscopy. All of these procedures are very familiar to the thoracic surgeon.~      The current feasibility and safety study examines C-VATS as a method of evaluating, biopsying~     and performing pleurodesis in patients with pleural disease and or effusion.~   "
162394|NCT01440231|"~     Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune~     system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells~     make proteins called antibodies, which in autoimmune disease can bind to one's own tissues~     and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called~     BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus~     the production of antibodies. This study will assess whether treatment with atacicept can~     reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not~     available outside of a clinical trial, and that its potential benefits and risks have not~     been fully determined.~      A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a~     1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept~     115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.~      The primary objective of the trial is to evaluate the efficacy of atacicept compared to~     placebo in reducing SLE disease activity in subjects treated with standard of care (SoC)~     therapy and to investigate the dose-response relationship.~      The secondary objectives of the trial are:~        -  To evaluate the effect of atacicept in reducing corticosteroid usage~        -  To evaluate the safety and tolerability profile of atacicept in subjects with SLE~        -  To confirm the PK and PD profiles of atacicept in SLE subjects~        -  To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey~          [SF-36].~   "
162395|NCT01440218|"~     This research is being done to learn more about possible genetic causes of currently~     undiagnosed conditions, and to find out how the development of new technologies, such as DNA~     sequencing, can increase knowledge of the role genetic variants play in disorders and~     possibly how genetic variants may help de-termine the best treatment options.~      The recent development of new technologies has increased our ability to understand how~     genetic mutations are associated with disease. Using these technologies to find the genetic~     variants responsible for rare diseases is a rapidly growing field and has already begun to~     transform the way conditions with unknown causes are diagnosed and treated.~      Hypothesis: Identification of new genomic variants associated with idiopathic diseases and/or~     diseases of unknown etiology will advance medical knowledge about rare and common diseases.~   "
162396|NCT01440205|"~     The mailer will encourage all employees of one of Evive's partner companies to attend an~     on-site free flu shot clinic they are offering in the fall of 2011. The research will examine~     differences in follow-through on getting a flu shot at an on-site clinic among the targeted~     population during the ~1 month period when clinics are being offered (following the mailing)~     as a function of experimental condition.~   "
162400|NCT01440153|"~     Professional dancing requires an almost perfect control of technical skills, combined with a~     good physical condition. To meet the demands of choreography, dancers need an adequate~     aerobic endurance capacity, muscular strength as well as flexibility and motor control~     (Twitchett et al. 2009; Roussel et al. 2009). One could compare these requirements to those~     of an athlete. In contrasts to athletes, only few attention has been given to the prevention~     of injuries in dancers. Professional dancers are at high risk to develop musculoskeletal~     injuries, especially, soft tissue and overuse injuries to lower extremities and~     spine(Hincapié et al, 2008). Several potential risk factors for injury have been suggested,~     such as a reduced level of aerobic fitness, lack of muscular strength, hypermobility of the~     joints and altered motor control of the lumbopelvic region but no conclusive evidence exists~     for any of these items separately.~      Applying sports science principles to dance training may improve the performances of the~     dancers (Twitchett et al. 2009). Dancers demonstrate low aerobic fitness and muscle strength,~     in contrast to the high demands. Aerobic endurance of dancers is for example comparable to~     healthy adults with a sedentary life style.~      Fitness programs, additional to regular dance classes, have only recently been considered~     (Twitchett et al. 2009). The advantages of additional training in athletes is beyond~     questioning. Nevertheless, this concept is relatively new for dancers. On the one hand,~     professional dancers do not consider themselves as a sportsmen but as artists (Wyon et al,~     2007). On the other hand, choreographers and dancers fear the negative influence of training~     on body aesthetics.~      Additional fitness training could improve physical fitness & motor control and may help with~     stress coping during public performances. Therefore, the purpose of this randomized~     controlled trial is to examine whether an additional intervention to regular dance lessons~     influences the physical condition and musculoskeletal injury rate in professional dancers.~   "
162401|NCT01440140|"~     The main study objective is to compare real-time continuous subcutaneous glucose monitoring~     (CGM) combined with overnight automated closed-loop glucose control, and real-time CGM alone~     in the home setting.~   "
162402|NCT01440127|"~     Metformin is drug that is normally used to treat people with diabetes. New research has~     discovered that metformin may also kill cancer stem cells. These cancer stem cells make up~     only a small portion of a cancer, but may be responsible for resistance to chemotherapy or~     for causing recurrence of the cancer. The purpose of this study is to determine the effect of~     metformin on colorectal cancer tumors. The study is designed to develop the methods to test~     tumors for cancer stem cells and then to determine the difference between treating with~     metformin and not treating with metformin with regard to the cancer stem cells. This research~     is investigational because the effect of metformin on cancer stem cells is not known in~     humans. Also, in patients who are not diabetic, metformin would normally not be given prior~     to surgery.~   "
162403|NCT01440114|"~     The propose of this study is to determine the effect of intravenous fentanyl prior the end of~     surgery on the incidence and severity of EA in pediatric patient.~   "
162404|NCT01440101|"~     The primary objective of Part A is to determine the safety and tolerability of natalizumab~     administered over 24 weeks in Japanese participants with relapsing-remitting multiple~     sclerosis (MS). The endpoints for this will include assessment of adverse evetns (AEs),~     changes in laboratory evaluations, vital signs, Expanded Disability Status Scale (EDSS)~     scores, and changes in physical and neurological examination findings. The secondary~     objectives of Part A are to characterize the pharmacokinetics (PK) profile and~     pharmacodynamics (PD) of natalizumab.~      The primary objective of Part B is to determine if natalizumab, when compared to placebo, is~     effective in treating Japanese participants with relapsing-remitting MS, as measured by new~     active lesions on cranial magnetic resonance imaging (MRI) scans over 24 weeks. New active~     lesions are the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly-enlarging~     T2-hyperintense lesions that do not enhance. The primary endpoint is the rate of development~     of new active lesions over 24 weeks.~      Secondary objectives of Part B are to determine over 24 weeks whether natalizumab, when~     compared to placebo, is effective in reducing the frequency of clinical exacerbations,~     reducing the number of Gd+ lesions, reducing the number of new or newly-enlarging~     T2-hyperintense lesions on brain MRI scans, increasing the proportion of relapse-free~     participants, and improving outcomes on visual analog scale (VAS) assessing the participant's~     global impression of his/her well-being. Additional objectives are to assess the safety and~     tolerability, the incidence of serum antibodies to natalizumab and the PK profile of~     natalizumab.~   "
162405|NCT01440088|"~     The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is~     safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft~     Tissue Sarcoma.~   "
162406|NCT01440075|"~     Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism.~      It has been reported worldwide, but it is ten times more common in Asian population. The~     annual incidence in children under 5 years in Europe is estimated at 8 to 100000. It is the~     second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of~     cases between 1 and 5 years, with a maximal incidence around the age of 12 months.~      It may results in acquired heart disease in children in developed countries, and may be the~     cause of premature coronary artery disease in adulthood.~      A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S~     population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are~     conflicting on this issue and the prevalence of this allel is unknown in North America and~     Europe populations.~      The clinical picture of KD associate a persistent fever and an antipyretics resistance with~     mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is~     confirmed by the presence of five clinical signs (major criteria). The presence of~     inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.~      KD can resolve spontaneously with no treatment. The severity of the disease is primarily~     related to complications of coronary aneurysms in acute or chronic stages.~      Several arguments support the fact that adult patients have diffuse vascular lesions~     different from aneurysmal lesions initially described in childhood.~      Despite abundance of publications on KD, there is no prospective or retrospective study which~     explored anomalies resulting from KD in adult subjects.~      Therefore, this project will describe the patient's vascular evolution, the prevalence of~     atherosclerotic lesions and to determine the biological and functional abnormalities, markers~     of accelerated atherosclerosis.~      Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in~     adulthood.~      The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent and~     their severity in adults with a history of KD in childhood compared to a control population.~   "
162407|NCT01440062|"~     Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple~     Sclerosis (MS).~   "
162408|NCT01440049|"~     On a population of patients followed by an office-based cardiologist and treated with~     eplerenone, the objectives of the survey are:~        -  To describe the characteristics of the population treated.~        -  To describe the methods of use of eplerenone (posology, duration of treatment, medicinal~          combinations).~        -  To describe the follow-up methods of the treatment.~        -  To describe the possible interruptions of the treatment~   "
162409|NCT01440036|"~     The objective of the research, is to examine the hypothesis, that the enzyme paraoxygenase 1~     ( PON1) can influence carotid artery's atherosclerotic plaque content and stability, and its~     relation to plasma's enzyme concentration.~   "
162503|NCT01438814|"~     The aim of this study is to investigate the impact of the combination therapy of linagliptin~     and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and~     metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of~     with type 2 diabetes mellitus.~   "
162410|NCT01440023|"~     Many researchers suspect that individuals with Tourette Syndrome (TS) may have a poor~     cognitive ability (i.e., response inhibition; RI) that is essential to inhibit inappropriate~     response such as vocal or motor tics. The investigators aim to test whether a~     well-established behavior therapy for TS can be improved by increasing the individual's RI~     capabilities. To this end, 20 children will be randomly assigned to behavior therapy with~     computer-based RI training or behavior therapy with placebo computer-based cognitive~     training. The investigators will test the hypothesis that computer-based RI training can be a~     useful addition to the well-established behavior therapy to enhance its therapeutic effect.~   "
162411|NCT01440010|"~     Quality control of IORT as a boost with 20 Gy followed by EBRT~   "
162412|NCT01439997|"~     The objective of this study is to find out what the pharmacodynamic (PD) characteristics of~     desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The~     main questions the investigators want to answer are:~        -  Are differences related to the pathophysiological factors involved in nocturia?~        -  Are there age/gender/size differences?~        -  Can the investigators identify patients who are likely to develop hyponatraemia?~        -  Can the investigators individualize treatment and reduce risk for hyponatraemia?~      The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy.~     During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.~      There are two groups of patients:~      Group A:~      Patients that still have to undergo an evaluation phase, according to standard procedures~     (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study~     starts when the 1st Minirin Melt tablet has been taken (= day 1).~      Group B:~      This group already went through the evaluation phase (by participation to study 1 or study 3~     as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.~      The study starts when the patients takes his first prescribed Minirin Melt tablet:~        -  On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+,~          K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day~          3 and day 7) are standard procedure. If the patient is at high risk for side effects,~          blood has to be taken during the first 7 days.~        -  On day 3 the patient has to give a urine sample.~        -  Patients have to fill out a frequency/volume chart during the first 14 days.~        -  On day 30, a 3rd blood sample will be taken~   "
162413|NCT01439984|"~     The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the~     treatment of premature ejaculation.~   "
162414|NCT01439971|"~     This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe~     to administer to subjects with severe Hemophilia A or B with or without inhibitors and will~     demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in~     hemophilic animal models.~   "
162415|NCT01439958|"~     The purpose of this study is to evaluate long-term safety of L-CsA in prevention of~     bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients~     previously enrolled in phase II/III L-CsA clinical trial 12011.201.~   "
162416|NCT01439945|"~     RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of~     breast cancer.~      PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of~     magnesium oxide works compared to placebo in treating menopausal women with hot flashes and a~     history of breast cancer.~   "
162417|NCT01439932|"~     Background: Plantar fasciitis (PF) is a common problem that tends to attack about 10% of the~     population during life. This is a degenerative condition of the plantar fascia at its~     insertion at the bottom of the heel. Pain appears mainly on the first steps in the morning or~     after prolonged lack of weight bearing. The pain intensity can be very high and this can~     cause functional limitations and reduce quality of life.~      Despite the high prevalence of the PF, treatment is controversial and not supported by~     extensive research. Review of the previous studies on various treatments, mentioned steroid~     injections, shock waves, night splint, orthotics, heel padding and stretching exercises.~      Limitation of ankle dorsi flexion is a common finding and thought to be a contributing factor~     to the development of pathology. So far, this issue had been addressed mainly by soft tissue~     therapy techniques to improve ankle range of motion in patients with PF. Only one study~     (Joshua et al 2009) evaluated the effect of ankle joint mobilizations of PF. However, in this~     study mobilizations were part of complex therapy and therefore the effect of treatment cannot~     be attributed solely to them.~      The purpose of this study is to evaluate the effectiveness of ankle and mid-foot joints~     mobilization on pain and function of patients with PF.~      The hypothesis is that manual mobilizations of ankle and midfoot joints in addition to~     conventional physical therapy will improve pain and function significantly more than~     conventional treatment, in patients with PF.~      Methods: 50 patients, age 18-75 with a diagnosis of PF that meet the inclusion criteria will~     be recruited and randomly divided into two groups. Both groups will receive commonly accepted~     physical therapy treatment that includes stretching exercise of the plantar fascia and~     triceps surae muscles and ultrasound therapy at the site of symptoms. The study group will~     receive in addition manual mobilizations to the ankle and midfoot joints. The procedures will~     take place at the physiotherapy clinic Bat-Yamon of General Health Services and will last~     four weeks, twice a week.~   "
162418|NCT01439919|"~     The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily~     compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric~     Rating Scale (NRS).~      Secondary Objectives are:~        -  To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency,~          background therapy utilization, mood, patient satisfaction of pain relief, nausea,~          constipation, healthcare utilization and quality of life;~        -  To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for~          persistent cancer pain;~        -  To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and~          cancer pain treatment;~        -  To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for~          persistent cancer pain;~        -  To assess endocannabinoid plasma concentrations.~   "
162419|NCT01439906|"~     The study aims to analyze the surgical treatment of low back pain due to degenerative~     kyphoscoliosis, already routinely performed on patients treated in Istituto Ortopedico~     Rizzoli, in terms of reduction of the pain and functional improvement. The comparison of back~     pain and functional ability before and after the surgical treatment will be performed by~     administering to the patients specific questionnaires (Visual Analog Score VAS, Oswestry~     Disability Index ODI, Quality of Life EuroQoL 5D). Questionnaires administration will be~     matched to a purely objective and radiological assessment according to international~     guidelines. A psychological analysis will be also performed in order to evaluate co-morbidity~     from this field, considering that the concept of shared decision-making for the therapeutic~     approach to low back pain requires the evaluation of all these parameters.~   "
164144|NCT01417286|"~     This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery~     works in treating patients with breast cancer. RT uses high energy x rays to kill tumor~     cells. Giving RT after surgery may kill any remaining tumor cells~   "
162424|NCT01439841|"~     HIV progression is closely associated with chronic immune activation driven by leakage of~     bacterial products from a damaged gut, the investigators largest immunological organ.~     Notably, the degree of immune activation has been suggested to be a better predictor of~     disease progression than plasma viral load, and markers of immune activation and gut damage~     have been identified as therapeutic targets per se. The major damage by HIV to the immune~     system is an initial massacre of gut mucosal CD4+ Th17 cells. Interestingly, a normal gut~     flora has been shown to induce the maturation of Th17 cells in the small intestine mucosa.~     Preliminary reports have shown that the gut flora is altered in HIV-1 infection compared to~     controls. In this project, the investigators will characterize microbial composition of gut~     flora in chronic HIV infection with ultradeep sequencing. Gut flora composition will be~     related to clinical data as well as quantitative data of circulating microbial products and~     activation markers. Second, in a randomized clinical trial (RCT) the effect of probiotic~     lactobacilli on HIV pathogenesis and progression will be tested. This Gram-positive strain is~     clinically tested and is able to colonize the gut.~   "
162425|NCT01439828|"~     The primary purpose is to assess the efficacy in human of N-acetylcysteine versus placebo~     during 4 weeks in cannabis withdrawal.~   "
162426|NCT01439815|"~     The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal~     spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following~     ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.~   "
162427|NCT01439802|"~     The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices~     (IUDs) placed at time of Cesarean Delivery.~   "
162428|NCT01439789|"~     Multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based~     phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on serum~     NT-proBNP, as well as safety in patients with chronic heart failure.~   "
162429|NCT01439776|"~     Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy~     obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3~     Studies rarely address the issues of improving host factors. The current study examines~     whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral~     response(SVR)compared to Peg/RBV.~   "
162430|NCT01439763|"~     The specific aims of this study are:~        -  To determine the prevalence of bullying in children who present to the ED with~          behavioral symptoms~        -  To assess mental health diagnoses and their relationship to type, severity and frequency~          of bullying behaviors, as well as demographic and psychosocial correlates (socioeconomic~          status, stress and support) and their relationship to type, severity and frequency of~          bullying (bullies versus victims).~        -  To explore the attitudes, values, triggering events and potential solutions using~          qualitative methods~        -  To gain greater insight into the patient experience and perceptions of the bullying~          events~   "
162431|NCT01439750|"~     This is a phase I/II trial of bortezomib, cladribine, and rituximab in newly diagnosed and~     relapsed mantle cell lymphoma (MCL). The phase I component has three dose levels of~     cladribine (3 mg/m2, 4 mg/m2, and 5 mg/m2) and is designed as a traditional dose-escalation~     study in which cohorts of 3 patients are evaluated for the incidence of dose-liming toxicity~     (DLT) at each dose level. Once the maximum tolerated dose (MTD) is determined, a phase II~     component with 2 arms will begin. One arm will enroll newly diagnosed MCL patients and one~     arm will enroll relapsed MCL patients. Each arm is a single-stage, fixed sample size study~     and will be accrued and analyzed separately. The phase I and II data will also be analyzed~     separately.~   "
162432|NCT01439737|"~     Asthma is a chronic inflammatory airway disease. Significant heterogeneity exists in the~     clinical manifestations and treatment responses in these patients. Metabolomics is a~     large-scale approach to monitoring as many as possible of the compounds involved in cellular~     processes in a single assay to derive metabolic profiles. Compared with genomics or~     proteomics, metabolomics reflects changes in phenotype and therefore function. Up to now, few~     studies have evaluated the role of metabolomic analysis in the diagnosis and prognostic~     evaluation of airway disorders. Collection of exhaled breath condensate (EBC) is a newly~     developed, noninvasive method that may allow clinicians and researchers to assess biochemical~     profiles in the alveolar lining fluid. This study will apply metabolomics to examine the~     biomarkers in the EBCs, serum and urine specimens in adult asthmatics.~   "
162433|NCT01439724|"~     Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas~     patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level~     laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This~     study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the~     incidence and/or severity of oral mucositis.~   "
162434|NCT01439711|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by~     lowering the amount of estrogen the body makes.~      PURPOSE: This phase II trial is studying how well letrozole works in treating women with~     ductal carcinoma in situ.~   "
162435|NCT01439698|"~     The objective of this protocol is to establish a multicenter registry to evaluate the impact~     of radiofrequency ablation in the management of patients with pancreatico-biliary disorders~     including malignancies.~   "
162436|NCT01439685|"~     This study entails retrospective and prospective review of data from a database protocol.~     Data gathered will be then analyzed for a set amount of patients. In this study, the~     investigators will compare biliary stenting vs. biliary stenting plus photodynamic therapy~     (PDT) and assess if PDT can improve quality of life and prolong survival.~   "
162437|NCT01439672|"~     This protocol will investigate physiological parameters including insulin sensitivity and~     counterregulatory function using a mixed meal test and induced hypoglycemia in subjects with~     type I diabetes.~   "
162438|NCT01439659|"~     The goal of this clinical research study is to see if ovarian cancer patients who add Juice~     PLus+ and Juice Plus+ Complete to their diets have better outcomes when compared to ovarian~     cancer patients who receive only dietary counseling alone.~   "
162504|NCT01438801|"~     The evaluation of a standardized diagnostic test to predict the growth response in a 1 year~     trial with Growth Hormone (GH) treatment (carried out in the context of regular patient care)~     in non GH deficient short children with low serum insulin-like growth factor-1 (IGF-1).~   "
162439|NCT01439646|"~     Retrospective, observational study To study the effect of Empirical Antifungal therapy on~     clinical outcome in high risk patients with suspected Invasive Fungal Infection admitted in~     ICU/Critical care unit, To know the current epidemiology of IFI and management approach in~     patients at high risk of Invasive fungal infections, Identify the risk factors associated~     with Invasive fungal infections, To comment on the appropriateness of empirical therapy used~     based on proven/probable diagnosis~   "
162440|NCT01439633|"~     The specific aim of this study is to determine the feasibility of marking target pathologic~     locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial~     cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of~     biopsy.~   "
162441|NCT01439620|"~     The goal of this study is to evaluate the potential of comprehensive biliary Optical~     Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct~     strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing~     cholangitis (PSC).~   "
162442|NCT01439607|"~     Gaucher disease is an inherited autosomal recessive lysosomal storage disorder caused by the~     defective activity of the glucocerebrosidase, leading to accumulation of glucocerebroside~     particularly in cells of the macrophage lineage. Clinical manifestations associate~     hematological, neurological and bone disorders.~   "
162443|NCT01439594|"~     The goal of this research is to conduct a pilot clinical study to evaluate the potential use~     of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of~     injury associated with therapeutic radiofrequency ablation techniques.~   "
162444|NCT01439581|"~     To determine if a device that measures and displays pressure that the patients feel when in~     bed can help nurses reposition the patient effectively and thereby reduce bedsores in the~     intensive care unit.~   "
162445|NCT01439568|"~     The purpose of this trial is to compare the progression free survival of LY2510924 +~     carboplatin + etoposide therapy versus carboplatin + etoposide therapy in patients with~     extensive-stage disease small cell lung cancer (SCLC)~   "
162446|NCT01439555|"~     Purpose of the study: Patients with mild Alzheimer's Disease will be given three different~     drugs over a 4-month period to try to increase the blood flow to their brains, and improve~     blood vessel and brain function. Each drug can help to open the blood vessels in the brain,~     and together they may be more effective than each drug alone. The hypothesis is that small~     blood vessels secrete substances that maintain the integrity of the brain, and may prevent~     loss of nerve cells leading to Alzheimer's Disease~   "
162447|NCT01439542|"~     The purpose of this study is to examine the safety of a shorter course of radiation~     treatments combined with one year of androgen deprivation therapy. The study will test this~     treatment in men with high risk prostate cancer who have significant other illnesses or~     circumstances such that conventional long term radiotherapy and hormone therapy is not~     recommended by their physician or desired by the patient.~   "
162448|NCT01439529|"~     New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated,~     such as the use of the electrocardiogram.~      In this prospective, double-blind, study, the investigators will evaluate:~      Primary endpoint: To compare the clinical response to CRT in patients with the programming~     optimized by QRS versus the nominal suggested by the device.~      Secondary endpoints:~        1. To compare cardiac remodeling in patients with the programming optimized by QRS versus~          the nominal suggested by the device.~        2. To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS)~          with respect to the intrinsic rhythm.~        3. To evaluate the echocardiographic improvement in left ventricular (LV) filling in both~          groups.~        4. To evaluate the differences in the optimal atrioventricular (AV) delay with atrial~          sensing or atrial pacing.~      For that, 180 patients with an indication for CRT will be randomized to nominal programming~     of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and~     echocardiographic evaluation will be done at baseline, 6 and 12 months.~   "
162449|NCT01439516|"~     African Americans are less likely than Whites to receive kidney transplants, despite their~     being more than two-fold as likely as Whites to develop end stage renal disease (ESRD).~     Living related kidney donation (LD) offers patients an opportunity to bypass many barriers to~     receipt of deceased kidney transplants (e.g. waiting lists and immunological~     incompatibility), but minorities are less likely to receive living related kidney transplants~     (LRT). Evidence suggests African Americans may not discuss LD/LRT with their families or~     physicians at optimal rates, and thus may not have adequate information to initiate or~     participate in shared decision-making regarding LD/LRT. African Americans may also have~     financial concerns regarding convalescence and out of pocket expenses related to LD/LRT,~     another barrier impeding LD/LRT.~      The primary goals of this study are to overcome these important barriers by enhancing ethnic~     minorities' consideration of LD/LRT through the promotion of shared decision-making regarding~     LD/LRT and provision of financial assistance for out of pocket expenses. The investigators~     specific aims are: a) to develop culturally sensitive informational (audiovisual) and~     financial interventions and b) to perform a randomized controlled trial to assess their~     effectiveness in increasing pursuit of LD/LRT among African American patients with ESRD and~     their families. The investigators hypothesize: (1) Patients and families who view~     informational materials designed to promote shared decision-making regarding LD/LRT will be~     more likely than patients and families not viewing these materials to discuss LD/LRT with~     family and with health care professionals. Patients and families viewing such informational~     materials will also be more likely than those not viewing these materials to pursue and~     complete the LD/LRT process and (2) patients and their families who are offered the~     intervention to promote shared decision-making plus a financial assistance intervention for~     potential live kidney donors will be more likely than patients and families not offered both~     interventions to pursue and complete the LD/LRT process.~   "
162459|NCT01439386|"~     This prospective, multi-center, single blinded study aims to compare the influence of two~     different catheter ablation strategies, on long-term ablation outcome in terms of AF~     recurrence and quality of life (QoL) in patients presenting with coexistent AF and AFL. The~     two strategies to be evaluated are 1) the ablation of paroxysmal atrial fibrillation (PAF)~     with or without flutter (AFL) ablation (AF ± AFL) versus 2) AFL ablation alone.~   "
162460|NCT01439373|"~     GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of~     chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and~     pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and~     ribavirin in subjects with chronic hepatitis C (CHC).~   "
162461|NCT01439360|"~     The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK~     Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine~     comparators in children 6 to 35 months of age. Recruitment will encompass at least 4~     independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort~     in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a~     fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and~     subtropical countries (beginning 2014).~   "
162462|NCT01439347|"~     A phase 3 study in the treatment of subjects >or= 60 years old with newly diagnosed acute~     lymphoblastic leukemia (ALL).~   "
162450|NCT01439503|"~     To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620~     eligible African American men who have sex with men (MSM) will be conducted. Men in the~     treatment condition will be compared to men receiving the control condition comprised of~     standard of care counseling from the clinic plus a free bag of condoms and water-based~     lubricants. This two-arm trial will test four hypotheses:~      Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed~     to reduce STD incidence and risk of HIV acquisition/transmission among young African American~     men (15-29 years old) having sex with men and presenting for STD testing.~      H1. Men randomized to receive the intervention will have a lower incidence rate of~     laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving~     the control condition.~      H2. Men randomized to receive the intervention will report significantly fewer acts of~     unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments~     compared to those receiving the control condition.~      H3. Men randomized to receive the intervention will report having significantly fewer~     unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between~     follow-up assessments compared to those receiving the control condition.~      H4. Men randomized to receive the intervention will report having significantly fewer~     negative experiences with condom use between follow-up assessments compared to those~     receiving the control condition.~      H5. Men randomized to receive the intervention will demonstrate significantly greater~     improvement in condom application skills, throughout the 12-month study, compared to those~     receiving the control condition.~   "
162451|NCT01439490|"~     Estrogens are implicated in the development of ovarian cancer and estrogen receptors (ER)~     alpha and beta are present in 20-100% of ovarian cancer patients. For this reason,~     antihormonal therapy with anti-estrogens or ER-antagonists is potentially an attractive~     treatment option. However, only a small proportion of patients (5-19%) will respond to~     antihormonal therapy. ER-expression in ER-positive breast cancer can be assessed by positron~     emission tomography (PET) with [18F]fluoroestradiol (FES). In this study the investigators~     will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian~     cancer. If these results are positive, this would warrant further exploration of FES-PET~     imaging in ovarian cancer.~   "
162452|NCT01439477|"~     Cardiovascular disease (CVD) is the leading cause of death for women in the United States.~     CVD disproportionately affects underserved populations, specifically low-income, minority,~     and rural women who have higher obesity rates and experience other health disparities. There~     is a need for replicable, evidence-based programs that target women, particularly midlife and~     older women who represent an increasing proportion of the U.S. population, to reduce their~     CVD risk . StrongWomen - Healthy Hearts is a 12-week, community-based program that has~     demonstrated effectiveness at improving CVD risk factors, including body weight, diet~     quality, and physical activity in a controlled, randomized trial conducted with midlife and~     older overweight and obese subjects in Arkansas and Kansas.~      The central objective is to rigorously evaluate dissemination of the StrongWomen - Healthy~     Hearts Program using the RE-AIM framework to achieve maximal public health impact. Expanded~     dissemination will occur through the Cooperative State Research, Education and Extension~     Service (CSREES) This partnership will leverage a long and successful collaboration between~     Tufts University and CSREES that provides strength training programs to older women in 41~     states.~   "
162453|NCT01439464|"~     The goal of this study is to compare Bonglass-SS with titanum cage.~   "
162454|NCT01439451|"~     The proposed project is a prospective experimental Randomized Control Trial study design.~     Independent old adults (age 70 years old and older) who do not suffer from balance problems~     willing to participate in the study will be tested before and after Peturbation balance~     training during walking to explore whether there are differences in balance control and~     balance reactions as a result of training.~   "
162455|NCT01439438|"~     This study is prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods. The volunteers received, in each period, the~     reference or the test formulation, according to the randomization list, under fasting~     conditions, in order to evaluate if the reference and test formulations are bioequivalent.~   "
162456|NCT01439425|"~     The relative risk of psoriasis and its severity are directly related to the body mass index~     (BMI).Patients with psoriasis likely undergo a vicious circle where obesity and skin disease~     reinforce each other. To investigate patients' opinion about their body weight (BW), the~     possibility of dietary approach to psoriasis, and to examine the adherence and the effects of~     hypo-energetic diet to maintain disease remission in obese patients a dedicated questionnaire~     was administered to 200 consecutive patients (125 men and 75 women) with moderate-to-severe~     chronic plaque psoriasis investigating whether diet factors could influence psoriasis~     severity and course. In second part of study, obese patients with psoriasis in remission~     (PASI improvement ≥ 75%) for at least 12 weeks after methotrexate therapy were randomly~     assigned to receive a hypo-caloric diet or free diet for 24 weeks, and then followed up for~     additional 12 weeks.~   "
162457|NCT01439412|"~     Acute low back pain is a common disorder in general practice. Some general practitioners~     (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its~     effectiveness for this condition.~      The aim of this study is to evaluate whether a single treatment-session with acupuncture can~     reduce time to recovery when applied in addition to standard LBP-treatment according to the~     Norwegian national guidelines. Analyses of prognostic factors for recovery and~     cost-effectiveness will also be carried out.~      The investigators hypotheses are:~        1. Acupuncture treatment contributes to faster pain-recovery in acute LBP compared to~          standard treatment in general practice provided in accordance with the Norwegian~          national guidelines.~        2. Acupuncture treatment for acute LBP improves function, and reduces drug use and sick~          leave, compared to the standard treatment in general practice provided in accordance~          with national guidelines.~        3. Acupuncture treatment for acute LBP is a cost-effective treatment in general practice.~      The investigators intend to include a total of 270 patients, 135 in the intervention group~     and 135 in the control group.~      The investigators planned to do an interim analysis when reaching inclusion of 150 patients.~     However, this might lead to reduced overall significance level, and as a result of slow~     inclusion rate (by December 2015), the investigators plan to extend the inclusion time with~     one year and then complete the study in March 2017.~   "
162538|NCT01438359|"~     The purpose of this study is to determine if Furosemide is affected by PA21.~   "
162463|NCT01439334|"~     The primary purpose of this research is to develop and evaluate the short-term efficacy of an~     innovative multiple behavior screening, brief intervention and referral to treatment~     (MB-SBIRT) model using social images and future self-images to simultaneously link and reduce~     prescription and other co-occurring drug use behaviors among emerging adults in a primary~     care setting serving a racially and economically diverse community. The long term objective~     of this research is to cost-effectively reduce prescription and illicit drug abuse, along~     with alcohol and tobacco consumption, and improve health-related quality of life among~     high-risk emerging adults often ignored in intervention research and services.~   "
162464|NCT01439321|"~     Chronic immune thrombocytopenic purpura (ITP) is characterized by low platelet counts and the~     risk of severe bleeding complications. The two recently introduced TPO-RA drugs, namely,~     eltrombopag and romiplostim, have shown efficacious sustained response with continuous~     administration. Both drugs are indicated for the treatment of thrombocytopia in patients with~     chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or~     splenectomy. While these trials address important clinical questions they were not intended~     to evaluate what happens in the real-world settings with actual patient living daily lives.~     The purpose of this health outcomes study is to understand how the two TPO receptor agonists~     (TPO-RA) currently available in the US are being used in clinical practice and how their use~     impacts chronic ITP patients' daily lives. The study hypothesis is that patients who switched~     to eltrombopag report a better health-related quality of life than those who switched to~     romiplostim. This study utilized a hybrid design of retrospective chart review study and~     cross-sectional patient survey. A customized Patient Case Report Form (CRF) will be used to~     retrospectively collect clinical data from patient medical charts where the primary cohorts~     consist of patients who have switched from other ITP medication to eltrombopag or~     romiplostim. A cross-sectional survey will be employed to collect patient reported outcomes~     (PRO) data, including health-related quality of life and treatment satisfaction, using a~     compository questionnaire. Analyses of cross-sectional survey data and retrospective medical~     chart review data in patients who switch to either eltrombopag or romiplostim from their~     prior primary therapy will be conducted.~   "
162465|NCT01439308|"~     This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by~     capsaicin challenge~   "
162466|NCT01439295|"~     Urinary ascorbyl peroxide level in the first week of life will be a good predictor of~     Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.~   "
162467|NCT01439282|"~     This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in~     combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65~     subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal,~     estrogen receptor (ER)-positive breast cancer.~   "
162468|NCT01439269|"~     The purpose of this study is to test the efficacy of a family nurture intervention in the~     neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family~     nurture are compared to infants receiving standard NICU care. The intervention enhances~     mother/infant interactions that are vital to early development in the infant. The main goal~     is to get the mother and infant into biological synchrony, emotional attunement and mutual~     calm through an activity referred to as a calming cycle. Mother's are encouraged to engage~     in the calming cycle activities as much as possible. Her increased effectiveness in calming~     her infant is hypothesized to improve the mother's view of her baby, reduce negative emotions~     about having delivered a baby prematurely, and help her gain confidence in her care-taking~     abilities, which in other studies predicted shorter length of stay and fewer~     re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle~     activities providing appropriate types of stimulation for their babies that are important for~     social, emotional, and neurobehavioral development. Since preterm babies are often easily~     upset, mothers will be taught how to comfort and calm their babies. Assessments in the NICU~     and in follow-up visits for two years will test the immediate and long-term effects of this~     new approach to the nurture of prematurely born infants.~   "
162469|NCT01439256|"~     This study focuses on an important patient behavior, medication-taking, and important~     physician behaviors: promoting medication regimen adherence in patients and appropriately~     modifying therapy when existing therapy results in inadequate therapeutic effect. The study~     will also explore the caregivers' (clinicians) behavior after relevant information about~     their patients' medication adherence and blood pressure control has been provided to them.~     The investigators focus on behavior change for patients and physicians and seek to change~     their behaviors to improve the health care delivery process and outcomes. The study aims at~     facilitating tertiary prevention of cardiovascular, cerebrovascular, and reno-vascular~     diseases by promoting better blood pressure control.~   "
162470|NCT01439243|"~     The objective of this study was to compare the rate and extent of absorption of donepezil 10~     mg tablet (test) versus Aricept® (reference), administered as 1 x 10 mg tablet under fed~     conditions.~   "
162471|NCT01439230|"~     The objective of this study was to compare the rate and extent of absorption of donepezil 10~     mg tablet (test) versus Aricept® (reference), administered as a 1 x 10 mg tablet under~     fasting conditions.~   "
162472|NCT01439217|"~     Specific Aim: Compare the endothelial function, arterial stiffness and components of~     metabolic syndrome of childhood Acute Lymphoblastic Leukemia (ALL) survivors to healthy~     sibling controls. Plan: A cross sectional study comparing ALL survivors to sibling controls~     including measures of endothelial function and arterial stiffness obtained form a peripheral~     artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and~     insulin.~   "
162473|NCT01439204|"~     The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667)~     drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers~     Squibb are comparable in healthy subjects~   "
162488|NCT01439009|"~     One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the~     morning for up to 14 days to heart failure patients with volume overload that does not show~     adequate response to other diuretics such as loop diuretics in order to investigate the~     effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy~     of tolvaptan during the treatment period will also be investigated.~   "
162474|NCT01439191|"~     The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human~     breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a~     humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment~     for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has~     been shown to increase both survival and response rate, in comparison to trastuzumab alone.~     CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical~     Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine~     were evaluated in patients with HER2-overexpressing metastatic breast cancer.~   "
162475|NCT01439178|"~     Purpose: To evaluate the acute changes in intraocular cytokines after intravitreal~     bevacizumab (IVB) in proliferative diabetic retinopathy.~      Design: Prospective, open-label, controlled, randomized interventional clinical trial.~      Participants: Twenty eyes of 28 consecutive patients who are scheduled for pars plana~     vitrectomy (ppV) for proliferative diabetic retinopathy were prospectively enrolled.~      Methods: All patients were randomly assigned to receive IVB either at 2 or 7 days before ppV.~     Aqueous humor samples were taken from anterior chamber just before IVB and at the time of~     surgery. Multiplex cytokine array were used to assay various cytokines~   "
162476|NCT01439165|"~     The purpose of this study is to describe the safety and immunogenicity of repeat~     administration of Adacel vaccine approximately 10 years following initial administration of~     the vaccine. Antibody levels prior to revaccination will also be used to characterize~     antibody persistence following initial vaccination 10 years earlier.~      Primary Objectives:~        -  To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine~          to those induced by Td Adsorbed vaccine.~        -  To compare booster response rates against tetanus and diphtheria induced by Adacel~          vaccine to those induced by Td Adsorbed vaccine.~        -  To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by~          Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants.~      Secondary Objectives:~        -  To describe the rates of immediate reactions, solicited reactions, unsolicited adverse~          events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td~          Adsorbed vaccine.~        -  To describe booster response rates for pertussis antigens following revaccination with~          Adacel vaccine.~   "
162477|NCT01439152|"~     BAY94-9343 is an antibody-drug conjugate (ADC) directed against the cancer antigen mesothelin~     on tumor cells.~   "
162478|NCT01439139|"~     The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus~     densitometry (DXA) in osteoporosis detection.~   "
162479|NCT01439126|"~     The purpose of this study is to determine the long-term efficacy and safety of KAPVAY™~     (clonidine hydrochloride) extended-release in children and adolescents with Attention Deficit~     Hyperactivity Disorder (ADHD)~   "
162480|NCT01439113|"~     The placement of peripheral intravenous lines (IVs) is central to the treatment of patients~     in the emergency department (ED). The procedure is used for phlebotomy and administration of~     a variety of therapeutic medications and intravenous fluids. This procedure is standard of~     care, and IVs are routinely placed by experienced emergency nurses.~      Occasionally, the nurse will have difficulty placing an IV line. The most common reason for~     this is an underlying medical condition, such as diabetes, severe peripheral vascular~     disease, obesity, or a history of intravenous drug use. When a nurse is unable to place an~     IV, the options are:~        1. Ask another nurse to attempt the line placement~        2. Ask a physician to establish access, which usually involves placement of a central~          venous catheter, a time-consuming procedure with higher risk of infection than a~          peripheral line.~      The use of bedside ultrasound has become commonplace in the modern ED, and the Tufts Medical~     Center ED possesses its own machine, which is used for a variety of indications including~     diagnosis of pregnancy, gall bladder disease, abdominal free fluid or pericardial effusion.~     Another key use of bedside ultrasound is the location of blood vessels. In fact, it is now~     expected that when placing a central venous catheter the clinician use ultrasound guidance,~     as the ultrasound clearly demonstrates blood vessels. The procedure is completely pain-free~     and harmless, and costs nothing to perform.~      Recently, there has been a growing body of evidence demonstrating that placement of~     peripheral IVs can be facilitated by the use of ultrasound. Just as it is useful for central~     venous catheters, ultrasound can also clearly show smaller peripheral veins. Multiple studies~     have demonstrated that physicians can place IVs with ultrasound guidance.~      However, nurses are the de facto experts at placing peripheral IVs as it is a usual procedure~     for them to perform and they perform the procedure multiple times a day. In this study, we~     will provide a two-hour training program to a cohort of nurses. The training program will~     instruct them in the use of single-operator ultrasound-guided IV placement. After training,~     once the nurse encounters a patient with difficult IV access (either 2 failed attempts or~     history of difficult access), the patient will be consented and randomized to either the~     standard of care (whatever the nurse elects to do) or use of the bedside ultrasound.~      In the meantime, the research assistant will measure time to IV placement starting from~     enrollment, the number of skin punctures that are necessary to place the IV, and then ask the~     patient questions about satisfaction with the IV placement and the pain they experienced.~      Our hypothesis is that single-operator, ED nurse use of bedside ultrasound will facilitate IV~     placement in patients with difficult IV access, saving time and also improving patient~     satisfaction and comfort.~   "
162481|NCT01439100|"~     To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy~     in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed by~     averaged 24 hour pain scores collected for 7 days prior to the clinic visits~   "
162482|NCT01439087|"~     The goal of this research is to conduct a pilot clinical study to image colonic polyps with~     the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to~     identify the extent of invasion (if present), differentiate between hyperplastic polyps and~     adenomas, and identify serrated polyps.~   "
162483|NCT01439074|"~     The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag)~     compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn~     injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be~     up to 4 weeks with either Mepilex Ag or SSD.~   "
162484|NCT01439061|"~     This is an Italian, Multicentre, Observational Study to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth~     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.~   "
162485|NCT01439048|"~     The purpose of this study is to determine if changes in specific gene products in the~     placenta or cord/infant blood affect a baby's birth weight, increase the risk of premature~     birth, or increase the risk of developing diseases of prematurity. We would also like to~     characterize whether placental epigenetic changes or placental markers of environmental~     exposures are associated with premature birth.~   "
162486|NCT01439035|"~     The goal of this research is to conduct a pilot clinical study to image Celiac disease~     characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to~     histologic evaluation in children, adolescents and young adults with suspected Celiac~     disease.~   "
162487|NCT01439022|"~     This study sets out to determine the effect of exercise performed over a longer period of~     time (6 months), delivered using community facilities, on motor and non motor symptoms,~     health and well being in people with Parkinson's Disease.~   "
162489|NCT01438996|"~     The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi~     antibody response following secondary vaccination with the Novartis Vaccines Institute for~     Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either~     the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01_04TP study (NCT01193907) and~     the immunogenicity and the kinetics of the anti-Vi antibody response following primary~     vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.~   "
162490|NCT01438983|"~     This is an observational, non-randomised trial to evaluate the effect of dietary type on~     infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45~     breastfeeding and 45 bottle feeding infants) who attended to Yazd clinic for regular~     pediatric appointment. Infants with unremarkable health histories, normal weight, free of~     sign or symptom of oral candidiasis or other mucosal disease. Their mothers were also healthy~     and without sign or symptom of vagina or mammary candidiasis. Pacifier usage, use of~     antibiotics in last months, sign or symptom of oral candidiasis in infants or vagina and~     mammary candidiasis in mothers were exclusion criteria.~   "
162491|NCT01438970|"~     This is a single centre, prospective, uncontrolled study to include 12 consecutive patients~     with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary~     objective) of the study is to investigate the effect of treatment of ascites by the Sequana~     medical pump on the renal and circulatory function in patients with cirrhosis and recurrent~     or refractory ascites. The secondary objectives are the following:~        -  To evaluate the efficacy of treatment for handling ascites, associated with changes in~          the body weight of patients and their requirements for evacuation paracentesis during~          follow-up.~        -  To investigate the effects of treatment on bacterial translocation, by means of~          determining bacterial DNA.~        -  To determine the incidence of complications associated with treatment in the course of~          follow-up.~        -  To evaluate the effect of treatment on quality of life of the patients treated,~          evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease~          questionnaire).~   "
162492|NCT01438957|"~     The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine)~     in patients who require sedation during the surgery that requires epidural or spinal~     anesthesia without intubation under monitored sedation care.~   "
162493|NCT01438944|"~     Evaluation to determine if auto-induction can be used as a surrogate measure of nicotine~     receptor up-regulation through an observational study using nicotine replacement therapy for~     two weeks and no intervention for two weeks.~   "
162494|NCT01438931|"~     The purpose of this study is to evaluate the efficacy and the safety of DA-9501~     (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation~     under monitored sedation care.~   "
162495|NCT01438918|"~     The objective of this 2-year study is to evaluate the safety, tolerability and disease~     modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS). The~     efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the~     medial tibiofemoral compartment of the study knee as the primary endpoint.~   "
162496|NCT01438905|"~     The purpose of this study is to examine the effects of a gentle pressure movement performed~     at the ankle by a physical therapist on muscle function and ankle motion in individuals who~     frequently twist (sprain) their ankle.~   "
162497|NCT01438892|"~     Several observational studies have evaluated the comparative treatment costs associated with~     each agent, particularly those within the anti-TNF class, but few have evaluated the impact~     of therapy compliance, persistence, treatment patterns on patient reported outcomes,~     healthcare utilization and costs, using a provider database. This study is designed to fill~     in this information gap.~   "
162498|NCT01438879|"~     Enterovirus and herpes simplex viruses 1 and 2 are the main causative agents of central~     nervous system infections.~      Instead, the role of lymphocytic herpesviruses in the etiology of central nervous system~     (CNS) infections is not clear, even if there is the positive cerebrospinal fluid (CSF)~     polymerase chain reaction (PCR)-result for the virus.~      The aim of this study is to evaluate the presence of DNA from lymphocytic herpesviruses in~     the CSF obtained from the immunocompetent patients with CSF pleocytosis and from the patients~     with normal CSF leukocyte count.~   "
162499|NCT01438866|"~     Sealants have been shown to be the most effective caries preventive measure in permanent~     dentition. Sealants of the primary molars soon after they erupt would reduce the total caries~     experience of the primary teeth of the children and could possibly also postpone the caries~     process in the permanent dentition.~      The aim of this study is to measure the caries preventive effect of sealants in primary~     molars. The specific objectives are: 1) to compare the number of new caries experience teeth~     and surfaces among the intervention group of 4-years old pre-school children during the 1~     year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish~     on the caries experience on the occlusal surfaces of the primary molars and on the total~     caries experience of all the primary and permanent teeth, 3) to test the feasibility of the~     sealant program in one kindergarten in Kuwait city.~   "
162500|NCT01438853|"~     This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded~     dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in~     subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least~     six subjects each were originally planned. Subjects were to be randomized in a 5:1 ratio to~     receive TNX-832 or placebo,respectively, administered as a single bolus infusion over 15~     minutes. Three cohorts of subjects were enrolled to the study and safety and pharmacokinetics~     of the study treatment were evaluated.~   "
162501|NCT01438840|"~     Core Study:~      To demonstrate that the efficacy of avatrombopag (in addition to standard of care) is~     superior to placebo (in addition to standard of care) for the treatment of adult participants~     with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura) (ITP) as measured~     by cumulative number of weeks of platelet response over 6 months of once daily treatment in~     adults participants who received at least 1 prior ITP therapy.~      Extension Phase:~      To evaluate the safety and tolerability of long-term therapy with avatrombopag in~     participants with chronic ITP (cITP).~   "
162502|NCT01438827|"~     The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+~     (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen~     induced allergic rhinoconjunctivitis with or without asthma.~   "
162505|NCT01438788|"~     -  This is a 2 stage exploratory study with a 3-month observational phase on the natural~          course, followed by a 12-month, open-label, non-comparative, single-arm, phase II pilot~          study on the efficacy, safety and tolerability of a low-protein diet (LPD) in 8 adult~          patients with Bethlem myopathy (BM) and Ullrich congenital muscular dystrophy (UCMD).~        -  Objective of this trial is to test the effect of a normocaloric LPD to reactivate~          autophagy in BM/UCMD patients. The primary end point of the study will be the change in~          muscle biopsy of Beclin 1, a marker of autophagy, at 1 year of LPD treatment when~          compared to baseline.~        -  The rationale rests on our discoveries that (i) mitochondrial dysfunction mediated by~          inappropriate opening of the PTP plays a key role in collagen VI myopathies; (ii)~          defective autophagy with impaired removal of defective mitochondria amplifies the~          defect; and (iii) reactivation of autophagy with a low-protein diet or treatment with~          cyclosporine A, the mitochondrial PTP inhibitor, cured Co6a1-/- mice, hinting at a~          common target among all beneficial treatments - namely autophagy.~        -  Specific aims of this project are to (i) study the modifications of clinical,~          nutritional and laboratory parameters in a cohort of patients with BM/UCMD during a~          3-month observational period before starting the LPD treatment; (ii) assess the effect~          of a normocaloric LPD in correcting defective autophagy in muscle of patients; (iii)~          test if new non-invasive biomarkers of activation of autophagy examined in the blood are~          mirroring the effect of LPD in the muscle biopsy; (iv) assess the clinical efficacy and~          safety of the LPD with an innovative combination of complementary measures of the~          nutritional status in patients.~        -  The anticipated output is defining and validating a therapeutic nutritional approach in~          autophagy upregulation for BM/UCMD.~   "
162506|NCT01438775|"~     This study is designed to demonstrate the safety and efficacy of a second transrectal~     intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH)~     who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.~   "
162507|NCT01438762|"~     Self-reported, unspecific knee pain is highly prevalent among adolescents. A large proportion~     of the unspecific knee pain can be attributed to Patellofemoral Pain Syndrome (PFPS). There~     are a number of treatment options for PFPS. Physical therapy has been advocated as one of the~     cornerstones in rehabilitation of patients with PFPS. Twenty-five years ago, McConnell~     proposed a multimodal approach that combined several treatment options. The regimen included~     retraining of the vastus medialis oblique muscle through functional weight bearing~     activities. This exercise is combined with patellar taping, patellar mobilization, and~     stretching to improve patellar tracking, reduce pain, and enhance vastus medialis oblique~     muscle activation. Short term results (<12 months) indicates that multimodal physiotherapy is~     more effective than placebo treatment.~      While treatment for PFPS may be successful for the short-term, long-term results are less~     promising. A recent review covering the long term prognosis for patients diagnosed with PFPS,~     reported that only 1/3 of those diagnosed with PFPS and treated conservatively were pain free~     12 months after diagnosis. Further ¼ stopped participating in sports because of knee pain.~      Predictors of long term outcome (>52weeks) indicate that a long symptom duration, higher age~     and greater severity at baseline are associated to poorer outcome after treatment. These~     prognostic factors suggest that an early initiation of treatment might lead to a better~     long-term prognosis. The purpose of this study is to examine the short and long-term~     effectiveness of multi-modal physiotherapy compared to standard wait-and-see treatment~     applied at a very early state of disease among adolescents. The investigators hypothesized a~     significantly larger proportion of completely recovered patients at three-month follow-up in~     the interventions group compared to the control group.~   "
162508|NCT01438749|"~     This randomized, placebo- and active-controlled, crossover study will evaluate the abuse~     liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1),~     subjects will receive a single dose of either diazepam or placebo in an inpatient crossover~     design, with a wash-out period of at least 10 days between treatments. Subjects who are~     clearly able to distinguish the positive control from placebo will be enrolled in the main~     study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels),~     diazepam and placebo in a double-blind, double-dummy inpatient crossover design.~     Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.~   "
162509|NCT01438736|"~     The purpose of the study is to examine how well three months preceding use of Cerazette~     progestin only pill predicts the bleeding pattern during following Nexplanon implant use.~   "
162510|NCT01438723|"~     Rationale:~      In patients with a myocardial infarction, occlusion of a coronary artery induces myocardial~     ischemia and cell death. If untreated, the area of myocardium exposed to this interruption in~     blood supply, will largely become necrotic. The only way to limit final infarct size, is~     timely reperfusion of the occluded artery. Paradoxically, however, reperfusion itself can~     also damage myocardial tissue and contribute to the final infarct size (reperfusion~     injury). Also during coronary artery bypass grafting (CABG), the myocardium is exposed to~     ischemia and reperfusion, which will induce cell death. Indeed, postoperatively, the plasma~     concentration of troponin I, a marker of cardiac necrosis, is increased, and associated with~     adverse outcome. The anti-hyperglycaemic drug metformin has been shown in preclinical studies~     to be able to reduce ischemia-reperfusion injury and to limit myocardial infarct size.~     Moreover, metformin therapy improves cardiovascular prognosis in patients with diabetes~     mellitus. Paradoxically, in patients with diabetes, current practice is to temporarily stop~     metformin before major surgery for the presumed risk of lactic acidosis, which is a rare~     complication of metformin. However, here is no evidence that this practice benefits the~     patient. The investigators hypothesize that pretreatment with metformin can reduce myocardial~     injury in patients undergoing elective CABG surgery~   "
162511|NCT01438710|"~     This study will evaluate and measure symptomatic hand tremor in stable kidney transplant~     subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion)~     and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro~     compared with Prograf or generic tacrolimus~   "
162512|NCT01438697|"~     This study will compare the efficacy of an interactive Internet intervention for adult~     insomnia (Sleep Healthy Using the Internet; SHUTi) to that of a static educational website to~     improve sleep, mood related symptoms, perceived health status, and overall quality of life.~   "
162513|NCT01438684|"~     The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state~     patients. The assessment will be done using clinical measurements and functional MRI studies.~   "
162514|NCT01438671|"~     Our hypothesis is the investigators will find a significant advantage for the use of a~     virtual reality system like the Wii Fit to improve overall balance scores versus the use of~     traditional balance activities alone. The objectives will be to determine the enjoyment of~     these types of gaming activities through the use of a survey to support the hypothesis that~     these activities are more enjoyable than traditional activities and to gather evidence to~     support the use of these more enjoyable activities as a viable and needed addition to the~     overall balance regimen given in the plan of care for a patient with traumatic or acquired~     brain injury, stroke or spinal cord injury.~   "
162539|NCT01438346|"~     This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB)~     for reducing substance abuse problems in women who are undergoing a substance abuse treatment~     program. The main hypothesis is that MBB will be more effective than the control (standard)~     intervention program in helping people reduce their craving for illicit substances and/or~     alcohol.~   "
162515|NCT01438658|"~     Uveal melanoma is the most common primary intraocular tumor in adults. The local treatment is~     effective, but patients still die of metastatic disease. It has been shown that early~     diagnosis of a few isolated metastases can result in a clean surgical excision of the~     metastases and an extension of the expected survival from 7-12 months to over 10 years on~     some patients.~      Many serum biomarkers are employed in Oncology. It makes sense to try the relevant ones in~     the diagnosis of metastatic uveal melanoma.~      The investigators hypothesis is that a soluble serum biomarker level changes upon development~     of metastatic disease either by secretion by the tumor cells themselves or by their~     environment. Detection of changes in biomarker level may lead to the diagnosis of metastases~     before they can be detected by imaging modalities, thus allowing for early treatment of the~     metastases and a better chance of success.~   "
162516|NCT01438645|"~     Colonoscopy is an established technology that enables doctors to obtain live video from~     inside patients' large intestines, which is essential for the diagnosis of numerous~     intestinal illnesses. It consists of a long, flexible tube fitted with a light-source and~     small video camera that transmits the images onto a display monitor. The doctor inserts the~     scope into the anus, moves it into the rectum and then guides it slowly through the entire~     colon. Because of the various twists and turns that are part of normal bowel anatomy,~     advancing the scope through the entire colon is not always successful and can become~     challenging when the scope forms loops inside the abdomen. Unfortunately, there is no way for~     the doctor to see the shape of the scope inside the body other than what is seen from the~     video at its front end, and so navigating the colon relies on instinct accumulated with~     experience and the feel of the scope as loops begin to form. This is important because not~     only can this loop formation cause pain, but it can also increase the likelihood of an~     incomplete test. Incomplete tests matter because a major reason for performing colonoscopy is~     colon cancer screening and surveillance; detecting early cancers at treatable stages and~     looking for polyps that may be pre-cancerous growths. When colonoscopy does not advance~     through the entire colon, parts are left unexamined where cancer may develop. A new~     technology called ScopeGuide has been developed that uses magnetic coils embedded within~     the scope to create a 3D image of the shape of the entire scope inside the body that is~     projected onto the monitor for the doctor to see. This will show if loops are forming and~     will provide information about how to eliminate loops once they have formed. In this research~     study, the investigators will compare colonoscopy with the assistance of ScopeGuide to~     colonoscopy performed in the standard fashion, to see if ScopeGuide results in more~     successful procedures that are easier for the doctor and more comfortable for patients.~   "
162517|NCT01438632|"~     A previous study showed that absorption and glucose-lowering action of rapid-acting insulin~     analogues occurred twice as fast when these analogues were administered by jet injection~     technology rather than by conventional insulin pen in healthy non-diabetic subjects. This~     study investigates if the rapid-acting insulin analogue aspart (Novorapid®) injected with~     jet-injection or a conventional insulin pen prior to a standardised meal in patients with~     diabetes shows the same difference in the pharmacokinetic and pharmacodynamic profile.~   "
162518|NCT01438619|"~     Epidemiological, clinical and animal-experimental evidence shows a direct relationship~     between dietary sodium intake, blood pressure and cardiovascular event. Diverse questionnaire~     and 24 hour urinary sodium measurement are used to estimate sodium intake. Complete~     reflection of eating and cooking habits to the dietary survey method is difficult.~     Furthermore, the differences of database between countries make it difficult to compare the~     amount of sodium intake between countries. It is also difficult to consider individual~     variation of cooking and eating habits. Due to limitations of dietary survey method, WHO~     recommended 24 hour urinary sodium measurement to estimated sodium intake in the population~     survey, and many countries are adopting. However, in Korea National Health and Nutrition~     Examination Survey, only dietary survey method has been used.~      The present survey study was designed 1) to test the feasibility of 24 hour urinary sodium~     measurement for the estimation of sodium intake (including percentage of complete 24 hour~     urine sample collection) in the population based study; 2) to establish feasible method of 24~     hour urinary sodium measurement; 3) to compare 24 hour urinary sodium measurement to the~     dietary survey method; and 4) to estimate the sodium intake by 24 hour urinary sodium~     measurement in Goyang city general population (aged 20-70 years).~   "
162519|NCT01438606|"~     The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in~     HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine~     that participants can safely receive.~   "
162520|NCT01438593|"~     The purpose of the study is to determine the safety and possible effectiveness of brain~     transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.~   "
162521|NCT01438580|"~     Current guidelines recommend standard warfarin anticoagulation international normalized ratio~     (INR) goal of 2.0-3.0 in adults with non valvular atrial fibrillation (NVAF). The~     investigators hypothesized that low-intensity warfarin (INR 1.5-2.0) has the same~     effectiveness and better security in elderly patients (>75) with NVAF.~   "
162522|NCT01438567|"~     The primary research objective is to demonstrate that subjects taking OXN PR have improvement~     in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to~     subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing~     the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).~   "
162523|NCT01438554|"~     The purpose of this study is to determine the safety and toxicity of the combination of~     pazopanib and GSK1120212 in patients with solid tumors and identify the maximum tolerated~     dose (MTD) of this combination for phase II study.~   "
162524|NCT01438541|"~     This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable~     subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular,~     surgical and orthopaedic medical care in the elderly admission, with a high risk to develop~     skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this~     investigation.~      The rational for this study is to evaluate the potential for Window in the prevention of~     pressure ulcers because of its ability to reduce shear and friction forces.~   "
162525|NCT01438528|"~     This is a Chinese, Multicentre, Observational Study to study Adherence and Long Term Outcomes~     of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone~     treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.~   "
162540|NCT01438333|"~     The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis~     CD2 tablets in addition to the primary treatment for patients with chronic periodontitis~     (Full Mouth Disinfection), at local level and at systemic level.~   "
162541|NCT01438320|"~     The goal of this study is to translate laboratory findings that Quercetin, a bioflavonoid, is~     safe and has antiviral activity in people with hepatitis C.~   "
162526|NCT01438515|"~     MRSA decolonization may reduce the risk of subsequent MRSA infection and further~     transmission. A recent randomized controlled trial demonstrated that systemic decolonization~     may be safe and effective among hospitalized patients when compared to no treatment. As a~     large number of the investigators patients require re-admission and further transmission may~     take place in the community, the investigators are comparing the standard decolonization~     protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory~     population.~      Standard decolonization protocols, which use only topical agents, are limited in efficacy.~     The method of systemic decolonization to be studied here appears to have greater efficacy~     than the standard approach using only topical agents. However, concerns have been raised that~     the increased use of systemic antibiotics may lead to increased levels of drug resistance~     adverse effects, without sustained decolonization. This study seeks to provide further data~     to help answer these questions and provide guidance for further policy development and~     implementation.~   "
162527|NCT01438502|"~     The purpose of this study is to verify that an infusion of hypertonic saline/colloids during~     cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with~     expected long-CPB-time.~      Expected beneficial effects are improved organ function for heart and lungs.~   "
162528|NCT01438489|"~     The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to~     placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus~     (SLE) with an inadequate response to standard of care treatment for SLE.~   "
162529|NCT01438476|"~     The goal of this clinical research study is to learn if there is a difference in patients'~     quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after~     surgery on the liver and/or pancreas. Researchers want to learn which method helps people to~     recover more completely and more quickly after surgery.~      The 2 kinds of pain control are intravenous (IV) pain management and epidural pain~     management.~   "
162530|NCT01438463|"~     The objective of the present study is to characterize the dose-response relationship of~     PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms~     of clinical efficacy and safety.~      For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due~     to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of~     treatment and at the end of the study patients will be subjected to a nasal provocation test.~   "
162531|NCT01438450|"~     Background Hepatocellular carcinoma, a malignant tumour of liver is one of the most common~     cancers worldwide. All India Institute Of Medical Sciences (AIIMS) being a tertiary care~     hospital receives about two to three cases of Hepatocellular carcinoma (HCC) each day in the~     investigators Gastroenterology out patient department. Most of these patients present late~     when the disease is already advanced and no curative therapies can be offered. At this stage,~     palliative therapy forms the mainstay of treatment. This includes transarterial~     chemoembolization (TACE) or Oral chemotherapy. Many patients also have involvement of~     branches of portal vein, which further limit therapeutic options. According to Barcelona~     Clinic Liver Cancer (BCLC) staging of liver cancer, involvement of portal vein precludes any~     standard form of therapy. These patients have been recommended for experimental therapies.~     Various forms of chemotherapy have been tried this group of patients. HCC is a vascular~     tumour and thalidomide is an anti-angiogenic drug and inhibits vascularity and has been used~     in the treatment of HCC. Capecitabine is a novel drug, which gives continuous delivery of~     5-FU and has been used in patients with HCC and has been found to be safe.~   "
162532|NCT01438437|"~     The purpose of this study is to assess the efficacy of Radiofrequency ablation (RFA) and~     percutaneous acetic acid ablation (PAI) in the management of small hepatocellular carcinoma~     (HCC) in patients of cirrhosis of liver.~   "
162533|NCT01438424|"~     The purpose of this study is to provide entecavir to participants who have completed another~     entecavir trial without achieving virologic response or who relapsed during postdosing~     follow-up.~   "
162534|NCT01438411|"~     The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic~     acid in subjects with identified inborn errors of bile acid synthesis.~   "
162535|NCT01438398|"~     The purpose of this study is to learn about the safety and usefulness of a procedure called~     endoscopic submucosal myotomy, which is a new technique in the treatment of achalasia.~     Achalasia is a disorder involving the lack of smooth muscle relaxation and sustained high~     pressure in the sphincter (muscle) of the lower esophagus. This may result in symptoms such~     as difficulty in swallowing, chest pain, regurgitation of food and eventually, weight loss.~      For more than a decade, a laparoscopic surgical procedure known as Heller myotomy has been~     the primary treatment for achalasia in patients with low surgical risk. In Heller myotomy,~     the surgeon makes three to four small abdominal incisions, inserts tube-like instruments~     through them, and once inside, the junction between the esophagus and stomach is found, a~     lengthwise incision is made on the muscular ring surrounding the lower esophageal sphincter~     which weakens the muscle and the lower esophageal sphincter or muscle (LES) is then able to~     open more easily. However, there is an emerging field known as natural orifice (opening)~     transluminal (through the lumen) endoscopic surgery (NOTES). This approach involves passing~     an endoscope - a thin tube with a built-in camera, light and minuscule tools through the~     natural opening in the body, like the mouth in order to perform less invasive surgery without~     any external wounds or scars. The procedure is done using the Submucosal Endoscopy with~     Mucosal Flap (SEMF) technique which involves passing an endoscope through the mouth into the~     esophagus, where a small incision is made on the lining of the esophagus, known as the~     mucosa. A balloon is then inserted and dilated in the submucosa - the layer between the inner~     lining of the esophagus and the outer wall consisting of the muscle of the esophagus.~     Dilation of the balloon in the submucosa creates a tunnel that allows insertion of the~     endoscope and access to the muscle of the lower esophageal sphincter (LES). A long incision~     is then carefully made on the posterior portion of the muscular ring that forms the LES. The~     incision divides the muscle fibers of the LES, which weakens the muscle, allowing for the~     easier passage of food while preserving some valve function to prevent reflux of acid from~     the stomach into the esophagus.~      The expected duration of participation is up to 10 years from the time study participants~     undergo the endoscopic surgical procedure.~   "
162536|NCT01438385|"~     Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ),~     Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year.~     Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or~     plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients~     suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal~     disorders. The investigators would like to assess prospectively the efficacy and safety of~     these routine procedures to permit identification of technical details about the procedures~     or other factors which might be associated with outcome or results. Assessment of these~     details would help us with problem identification and recommendations to improve health~     outcomes and quality of life in these patients.~   "
162537|NCT01438372|"~     The purpose of this study is to assess the safety and efficacy of intravenous iron sucrose in~     comparison to oral ferrous sulfate in improving iron deficiency anemia in children with~     inflammatory bowel disease.~   "
162542|NCT01438307|"~     Lung cancer is the leading cause of cancer death worldwide and in the United States. The~     majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases~     are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains~     limited at < 12 months median overall survival. New approaches are needed for second line~     chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in~     metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.~   "
162543|NCT01438294|"~     The purpose of this study is to assess the effects of a physical training program with active~     video game in inflammatory markers, quality of life variables , clinical control and physical~     and functional respiratory assessment of asthmatic children from 5 to 11 years.~   "
162544|NCT01438281|"~     The purpose of this study is to determine whether SYL1001 is safe for the prevention and~     treatment of ocular pain and dry eye syndrome.~   "
162545|NCT01438268|"~     Specific Aim: To assess the quality of recovery of patients following early discharge (18~     hrs) after pedicled TRAM flap breast reconstruction. Quality of recovery will be assessed~     using a 27-item validated questionnaire, QoR-27 at discharge, and on Post Operative Days~     (POD) 2, 4 and 7. In addition a 100 mm Visual Analog Score (VAS) for Pain will be completed~     on discharge from the recovery room, discharge from hospital and on POD 2, 4 and 7.~      Clinical Relevance: Postoperative recovery is a complex process related to various outcomes~     such as physiological endpoints, incidence of adverse events and change in psychological~     status. Previous studies of recovery after surgery and anesthesia have focused primarily on~     the physiological endpoints and the incidence of adverse events. Much of the work has~     occurred in specialties dealing with chronic disease states such as cancer, rheumatology and~     musculoskeletal disorders. There is clearly a need to focus on recovery outcome measures in~     the ambulatory population for postoperative recovery. Here the investigators propose to~     measure postoperative recovery outcomes within the first week following a TRAM flap~     reconstructive procedure using a validated postoperative quality of recovery instrument~     (QoR-27) and a 100 mm VAS for pain.~   "
162546|NCT01438255|"~     This is a prospective, non-comparative, open, observational study.~   "
162547|NCT01438242|"~     The purpose of this study is to examine the potential impact of the assay in terms of~     depression severity as measured by change in Clinical Global Impressions (CGI) scale at 3~     months.~   "
162548|NCT01438229|"~     This is a prospective, multicenter, feasibility study on the safety and efficacy of renal~     denervation in patients with resistant hypertension.~   "
162549|NCT01438216|"~     The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive~     care patients.~   "
162550|NCT01438203|"~     The objective of this study is to investigate the comparative benefit of thrust and~     non-thrust manipulation on a population of patients with low back pain. The investigators~     hypothesize that there will be no difference in 4 week outcomes or greater, between the two~     groups.~   "
162551|NCT01438190|"~     Because many women with Polycystic Ovary Syndrome (PCOS) are very sensitive to the use of~     gonadotropins, several strategies have been proposed to reduce the risk of Ovarian~     hyperstimulation syndrome (OHSS) and multiple pregnancies.~      The low dose step-up protocol and the step-down protocols in PCOS patients have been~     described in literature.~      The step-down regimen is designed to achieve the follicle stimulating hormone (FSH) threshold~     through a loading dose of FSH with a subsequent stepwise reduction as soon as follicular~     development is observed on ultrasound. On the contrary the step-up regimen is based upon the~     principle of a stepwise increase in FSH supply to determine the FSH threshold for follicular~     development. After commencement of gonadotropin administration, if follicle development is~     not observed on ultrasound after 1 week, an increase in the dose is recommended. Once~     follicle growth is observed, the same FSH dose is maintained until follicular selection is~     achieved.~      Preliminary studies report that both step-up and step-down regimens achieve similar high~     rates of monofollicular development. However, the largest study published so far has shown~     that the step-up regimen is safer in terms of monofollicular development.~      Recent data demonstrate that metformin administration in infertile PCOS patients who are at~     high-risk for OHSS reduces the incidence and severity of OHSS during gonadotropin ovarian~     stimulation in a step-down regimen for in vitro fertilization (IVF) programs.~      The aim of the present study will be to compare the conventional low dose step-up protocol~     and the combined protocol consisting in metformin and gonadotropin step-down regimen.~   "
162552|NCT01438177|"~     This pilot phase II trial studies how well giving bortezomib and cyclophosphamide together~     with chloroquine works in treating patients with relapsed or refractory multiple myeloma.~   "
162553|NCT01438164|"~     Evaluation of cost-effectiveness of FDG-PET for the public health system in Brazil.~   "
162554|NCT01438151|"~     The purpose of this study is to improve the investigators understanding of the relationship~     between Crohn's disease and blood levels of the drug infliximab (Remicade). The investigators~     want to determine whether measuring drug levels can be helpful in understanding how patients~     respond to this treatment.~   "
162555|NCT01438138|"~     RATIONALE: A screening test, such as My Profile Pediatric Assay, may help doctors predict a~     patient's risk of relapse and plan better treatment for acute myeloid leukemia.~      PURPOSE: This clinical trial is studying using the My Profile Pediatric Assay to see how well~     it works in predicting risk of relapse in bone marrow cell samples from younger patients with~     acute myeloid leukemia.~   "
162556|NCT01438125|"~     The objective of the study is to evaluate the safety and preliminary efficacy of MF-4181, a~     hydrogel scaffold, in improving scars and their resulting consequences following~     abdominoplasty or laparoscopy/laparotomy gynecologic procedures.~   "
162557|NCT01438112|"~     The use of a designed viral vector that can destroy cancer cells while leaving normal cells~     largely unharmed. The virus also stimulates an immunological response by producing a special~     factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It~     forms the hypothesis that this regimen may be used for people who have failed current forms~     of treatment and are recommended for cystectomy. It is with hope that this novel therapy will~     be able to delay or potentially avoid cystectomy for this patient population. Bladder~     instillation of this agent causes little long lasting side effects and may drastically~     improve the stimulation of the immune system for local cancer cell death as well as~     destroying those tumor cells that may have travelled to regional lymph nodes or distant~     organs.~   "
162559|NCT01438086|"~     When a patient has a heart attack, a blockage occurs in a coronary artery that delivers~     oxygen to the heart muscle. The heart muscle may weaken, causing heart failure. The body~     naturally makes a protein called insulin-like growth factor-1 (IGF-1) that may protect the~     heart muscle cells from dying and may prevent heart failure or lessen the damage that occurs.~     IGF-1 is also available as a drug called mecasermin. In this study, heart attack patients~     will be given either a dose of mecasermin or a placebo (inactive treatment) after their~     coronary artery has been opened by a stent. The purpose of the study will be to evaluate the~     safety of the therapy and to test if the therapy will prevent or lessen heart failure by~     evaluating a cardiac magnetic resonance imaging (MRI) taken one day and eight weeks after the~     heart attack.~   "
162560|NCT01438073|"~     The investigators are looking for subjects to complete a study on the role of kisspeptin in~     the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the~     body to produce other reproductive hormones. However, giving someone a continued amount of~     kisspeptin over a period of time can have the opposite effect and tell the body to, for a~     short time, stop making hormones needed for reproduction. By giving 24-hour infusions of~     kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way~     bodies function normally and the role it has in conditions that affect the reproductive~     system.~      The investigators are initially seeking healthy men, healthy women with regular menstrual~     cycles, and healthy postmenopausal women. In a later part of the study, the investigators~     will also enroll subjects with reproductive disorders. Study participation involves 2~     outpatient visits and one 38-hour hospital admission when subjects will receive kisspeptin~     and Gonadotropin releasing hormone (GnRH).~      Individuals interested in learning more may call 617-724-8764.~   "
162561|NCT01438060|"~     The primary objective of the study is to compare the efficacy of aripiprazole with placebo in~     patients with psychosis associated with Alzheimer's dementia.~   "
162562|NCT01438047|"~     This is a pilot exploratory study. The goal of this study is to evaluate a new imaging tool,~     optical frequency domain imaging (OFDI), to reveal the microvascular morphology of capillary~     malformations.~   "
162563|NCT01438034|"~     The investigators are seeking boys (ages 13.5-17 years) and girls (ages 12-17) years with a~     diagnosis of delayed puberty. Study participation involves 2 outpatient visits and two~     hospital admissions (one 11-hour, overnight admission and one 6-hour day admission) when~     subjects will receive two investigational drugs, the naturally occurring hormones kisspeptin~     and gonadotropin-releasing hormone (GnRH). Subjects will then be followed every 6 months~     until they reach 18 years of age to determine if their pubertal delay was self-resolved or~     permanent. Individuals interested in learning more may call 617-724-8592.~   "
162564|NCT01438021|"~     This pilot clinical trial studies continuous intraventricular methotrexate in treating~     patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving drugs directly into the ventricles may be an effective~     treatment for patients with leptomeningeal disease~   "
162565|NCT01438008|"~     Small amounts of sweet tasting sugar water reduces pain in babies during painful blood tests~     and injections. The investigators do not know if sugar also reduces pain in babies already~     receiving a continuous infusion of opioid analgesics. This project will help determine if~     small amounts of sugar water reduce pain in babies already receiving a continuous infusion of~     opioid analgesic during a heel lance procedure or nasogastric/orogastric (NG/OG) tube~     insertions. The investigators hypothesize that infants who are receiving opioid analgesics~     will have lower pain scores during their blood tests (heel lance) or NG/OG tube insertion,~     when sucrose is given, compared to when water is given.~   "
162566|NCT01437995|"~     This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group~     comparative effectiveness study of approaches to stepping down therapy for patients with~     well-controlled asthma treated with combination ICS and LABA.~   "
162567|NCT01437982|"~     The objective of this study is to identify any adverse events or adverse drug reactions~     through post-marketing surveillance under routine clinical practice~   "
162568|NCT01437969|"~     More than 1.5 millions individuals are infected with HCV in Italy. They are at risk to~     develop related morbidity and mortality from cirrhosis and hepatocellular carcinoma, unless~     the evolution of their disease is halted by treatment-induced HCV RNA clearance. Indeed, it~     is well recognized that a curative antiviral treatment, leading to HCV RNA undetectability 24~     weeks after the end of therapy, may prevent the occurrence of complications of HCV chronic~     liver disease.~      Several pre-treatment host and viral factors have been associated with the outcome of~     pegylated Interferon and Ribavirin treatment. These predictors are relevant as the ability to~     identify patients with the highest likelihood of achieving HCV RNA clearance may increase the~     number of patients who agree to be treated and who maintain their adherence to treatment.~      Several pre-treatment predictors as HCV genotype, HCV viral load, age, gender, body mass~     index, stage of fibrosis and race are very well recognized and have been used for many years~     during the treatment decision-making process. Based on studies of viral kinetics, HCV RNA~     undetectable at week 4 on treatment has been shown to represent the best on treatment~     predictor of response. In addition to these well known factors, very recently, a single~     nucleotide polymorphism (SNP) upstream of the gene IL28B on chromosome 19, coding for~     IFN-lambda 3 has been identified as associated with both spontaneous and treatment induced~     HCV RNA clearance.~      We have developed the molecular technique needed to evaluate this polymorphism in our~     laboratory. This technical process was a consequence of the genetics expertise of our~     research Institute. We have also performed a valuable comparison of the different methods to~     evaluate this polymorphism. Comparison of different technologies allow us to know the rate of~     variability between the different assays used.~      With this methodology we have evaluated a posteriori patients previously enrolled in~     Randomized Controlled Trial. The results of these studies confirmed the association between~     IL28B CC allele and a favorable outcome of HCV infection in our geographic area (Mangia et al~     Gastroenterology 2010; Mangia et al Hepatology 2010, AASLD presentation). We are now~     interested in prospective evaluation of patients referring to our center at the aim of~     understanding whether there are differences in the rates of IL28B frequencies in patients~     with different HCV genotypes.~      In fact, we hypothesize that the frequency of IL28B might be different according with~     different HCV genotypes and that this difference may explain the different rates of response~     to antiviral treatment reported in patients with HCV infection.~      Since we lead a collaborative group of hepatologists named AL-LIVER operating in Puglia,~     Lazio, Basilicata, Sicilia and Campania regions in Italy we would like to extend this~     evaluation to our collaborative group to explore in a large number of patients whether the~     prevalence of CC, CT and TT genotypes is inversely associated with HCV G1, 4, 3 and 2.~   "
162569|NCT01437956|"~     Serum KL-6 protein has been described as a biomarker of epithelial lung injury in Respiratory~     Syncytial Virus bronchiolitis. The investigators can imagine that epithelial injury intensity~     has consequences on immediate and later respiratory prognosis. Furthermore, this prognosis~     seems to be different according to the respiratory causative virus. The investigators propose~     to study, during an epidemic season, the correlation between KL-6 levels and clinical~     severity, and the type of viral infection.~   "
162570|NCT01437943|"~     The purpose of this study is to evaluate the effect of a short-term aliskiren treatment on~     kidney metabolism in patients at high risk for developing kidney dysfunction (i.e. kidney~     transplanted patients). The study is aimed at evaluating if any effect on kidney metabolism~     [using proton MR Spectroscopy(1H-MRS)] can be detected following a 6 months treatment with~     aliskiren regardless of its anti-hypertensive role. 1H-MRS can record a larger number of~     chemical species (up to 40) in the kidney, and monitor changes according to the pathologic~     state and health of the transplanted kidney.~   "
162571|NCT01437930|"~     The study was performed to investigate the effects of a daily consumption of n-3 PUFA~     supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk~     factors in hypertriglyceridemic patients.~   "
162572|NCT01437917|"~     The consumption of cereals-based foods with low glycemic indexes, high micronutrients and~     fibers contents are highly recommended. The target of this work is to provide new solutions~     for cereal based foods: the knowledge and understanding on the in vivo fate will be used to~     define structural features to gain in foods.~   "
162573|NCT01437904|"~     Outpatient tubeless Percutaneous nephrolithotomy (PCNL) could potentially improve patient~     care and result in significant cost savings for our hospital each year. If this pilot study~     is successful, Queen's/KGH will lead a collaborative national multicentre trial to further~     establish the role of this new approach in the surgical treatment of kidney stones.~   "
162574|NCT01437891|"~     An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and~     Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).~   "
162575|NCT01437878|"~     This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to~     evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to~     COPD. The main objective is to investigate the effect of iloprost on exercise endurance time~     during constant work rate cardiopulmonary exercise testing. Other efficacy and safety~     endpoints will additionally be analyzed.~   "
162576|NCT01437865|"~     The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared~     to current nodal staging methods.~      The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged~     nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will~     be regarded as the golden standard for nodal involvement.~   "
162577|NCT01437852|"~     The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study~     evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the~     healing of the deep partial-thickness component of complex skin defects. The proposed study~     population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin~     defects including a deep partial-thickness component resulting from thermal injury. The study~     has been designed to focus on the evaluation of safety and tolerability of prolonged exposure~     to increasing amounts of a single application of StrataGraft skin tissue, while also~     assessing the potential for StrataGraft tissue to promote healing of the deep~     partial-thickness component of these complex skin defects as an alternative to donor site~     harvesting and autografting. Targeted enrollment for this study is up to 30 patients with~     complex skin defects due to thermal burns which require surgical excision and autografting.~     Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving~     StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third~     cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in~     the operating room just prior to grafting.~   "
162578|NCT01437839|"~     To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial~     image tablets.~   "
162579|NCT01437826|"~     The trial was aimed at evaluating the efficacy of a multiagent antioxidant compound (vitamin~     A, C, E, selenium and zinc) in reducing the incidence of metachronous adenomas of the large~     bowel after endoscopic polypectomy. This is a randomized study: a 50% reduction in the~     incidence of metachronous adenomas was expected in patients allocated to the active~     compound (intervention) arm as compared to those assigned to a placebo.~   "
162580|NCT01437813|"~     Objective:~      The purpose of this study is to evaluate the effect of food intake in bioavailability (BA) of~     the combination Glimepiride/ extended release Metformin GLI/METXR (4/850mg) in healthy~     Mexican volunteers.~      Methods: A prospective, longitudinal, open label, non randomized study, was performed. A~     single oral dose of GLI/METXR (4/850 mg)was administered to 24 health Mexican volunteers 30~     min after a high fat meal. Blood samples were collected before the administration and 0.33,~     0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours~     post-administration. Plasma concentration of the drug was measured by using HPLC. Plasma~     concentration of botk drugs were measured using high-performance liquid chromatography~     (HPLC). Plasma concentration time curves were plotted for each volunteers, and~     pharmacokinetic parameters (PK) were calculated. Adverse events were determined using~     clinical and laboratory test results throughout the study.~   "
162581|NCT01437800|"~     Objective:~      The purpose of this study is to evaluate the oral bioavailability of the combination~     Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers.~      Methods: A prospective, longitudinal, open label, non randomized study, was performed, 24~     volunteers were administrated with a single oral dose of GLI/METXR (4/850 mg). Blood samples~     were collected over 30 hours. Plasma concentration of both drugs were measured by using~     high-performance liquid chromatography (HPLC). Plasma concentration-time curves were plotted~     for each volunteer, and pharmacokinetic parameters (PK) were calculated. Adverse events were~     determined using clinical and laboratory test results, throughout the study.~   "
162582|NCT01437787|"~     Primary Objective:~        -  To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503~          (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen~          volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in~          patients with contraindications for MRI).~      Secondary Objectives:~        -  To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as~          measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.~        -  To evaluate the Overall Survival of patients treated with either 400 mg/day or 500~          mg/day of IMP as compared to placebo.~        -  To evaluate the Progression Free Survival of patients treated with either 400 mg/day or~          500 mg/day of IMP as compared to placebo.~        -  To evaluate the durability of splenic response.~        -  To evaluate the safety of IMP.~   "
162583|NCT01437774|"~     The ReStore™ Thrombectomy device restores blood flow in the neurovascular by removing~     thrombus in patients experiencing ischemic stroke. Patients enrolled in the ReStore Trial~     will be randomized to treatment with the ReStore™ Thrombectomy Device (investigational~     treatment) or to treatment with a commercially available thrombectomy device It is expected~     that the investigational treatment safety profile in terms of clinically significant~     procedural adverse events will be comparable to the control group.~   "
162584|NCT01437761|"~     This study will compare how well blood of renal failure patients is cleaned with the new 2008~     Sorbent System using two different dialysate speeds.~   "
162585|NCT01437748|"~     -  The gold standard measures to evaluate small airways (SAW) in vivo is not well~          understood~        -  Two tests are today used to measure SAW but real results concordance is not clear~        -  These problems have a small evidence~        -  Data about real effect of bronchodilators on SAW (eg Tiotropium and Indacaterol) has~          never been studied~        -  Only an acute bronchodilators effect, after one hour of drugs inhalation, will be~          evaluated~        -  The time frame of study evaluations per patient will be of three hours: one hour for~          basal test; one hour rest after drug administration; one hour for post bronchodilators~          test~        -  All enrolled subjects will be outpatients and will be evaluated after 24 hours of~          inhalatory drugs washout~   "
162622|NCT01437267|"~     This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the~     Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid~     Fever is highly endemic and an efficacious vaccine against this disease is very much needed.~   "
162586|NCT01437735|"~     This study aims to demonstrate a clinically significant improvement in Forced Expiratory~     Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled~     by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active~     comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging,~     multi-centre trial.~   "
162587|NCT01437722|"~     The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the~     prevention of recurrence of bacterial vaginosis.~   "
162588|NCT01437709|"~     This study is being done to understand how to treat Mantle Cell Lymphoma (MCL). The goals of~     treatment are to control the lymphoma with the least amount of side effects. In many cases,~     MCL is treated with an antibody plus chemotherapy. An antibody is a laboratory-produced~     substance created to attach to proteins on the cancer cells, eventually destroying them.~     Chemotherapy is medicine that specifically destroys cancer cells.~      The purpose of this study is to find out what effects, good and/or bad, the drugs Ofatumumab~     and Bendamustine have on this type of cancer. Patients in this study will either receive~     Ofatumumab alone, or Ofatumumab combined with Bendamustine.~   "
162589|NCT01437696|"~     Vitamin D is essential to bone health. In Canada, it is obtained by sunlight exposure of the~     skin (between April and October) or by a few foods such as fatty fish, eggs or fortified milk~     and margarine. This study has 3 main goals which are to determine if Veteran's have enough~     vitamin D stored in their body, if adding a supplement of 2000 IU/d is enough to correct low~     vitamin D stores and, if specially formulated foods using an approved vitamin D supplement,~     are appropriate to maintain vitamin D stores in relation with functional and cognitive~     status. Initially, a 2000 IU supplement of vitamin D will be provided for 8 weeks. After this~     period, the participants will be randomly separated into 3 groups (Group A, B or C) for a~     period of 24 weeks. Group A will receive their usual menu. Group B will receive their usual~     menu with 1 portion of food containing 500 IU of added vitamin D. Group C will receive their~     usual menu with 1 portion of food containing 1000 IU of added vitamin D. Food intake will be~     assessed every 8 weeks and blood samples will be taken every 4 weeks to monitor change in~     blood concentration of vitamin D and other indicators of bone health. The investigators will~     document weight and height, hand grip strength, the mid-arm and mid-calf circumferences, the~     capacity to perform activities of daily living, the number of prescriptions and changes in~     health condition. The investigators will also take an X-ray the tibia and upper arm to~     document the amount and quality of bones in those regions. A total of 60 veterans of~     Ste-Anne's Hospital will participate in this study. Knowing more about vitamin D status and~     intake will help in confirming the required vitamin D recommendations for the elderly men~     living in long-term care institutions.~   "
162590|NCT01437683|"~     The primary objective of the protocol is to study the long-term outcome of a large group of~     traumatic brain injury patients.~      This outcome is to be described in terms of activity, participation, quality of life,~     SOCIO-professional outcome and impact on caregivers, and in relation to health care~     provision.~      The secondary outcome is to measure the impact on functional outcome of several predictive~     factors, and their relative importance on outcome. Our principal hypothesis is that~     SOCIO-professional and health provision factors play a major role on long-term outcome,~     further even than initial severity of brain injury.~   "
162591|NCT01437670|"~     A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with~     solifenacin~   "
162592|NCT01437657|"~     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the~     safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive~     disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on~     study treatment is 6 weeks with a 3-week follow-up.~   "
162593|NCT01437644|"~     Cerebral palsy is common. It affects approximately 3 per 1000 children. Hip displacement due~     to muscle tightness (spasticity) occurs in up to half of the more severely affected children,~     and many of these children require major (bony) hip surgery. After bony hip surgery the~     management of pain is very difficult, as spasticity tends to increase and causes painful~     spasms which are difficult to control. Botulinum Toxin injections are known to reduce~     spasticity and therefore should also reduce pain. These injections take at least a week to~     work, but the effects can last for months. Botulinum Toxin is already an established~     treatment for chronic hip pain prior to surgery. The investigators aim to find out whether~     Botulinum Toxin injections can reduce post-operative pain. The identification of the level of~     pain can be challenging because most of these children are unable to communicate verbally.~     The investigators are therefore using a validated pain scoring tool that was designed~     especially for such children. This study will be the first to describe fully the pain~     experience of children with cerebral palsy undergoing this type of major surgery. The~     investigators will compare Botulinum Toxin injections with placebo (non-active) injections.~     There is a high emotional and financial burden on the families of these children. Families~     describe high levels of emotional distress around the time of surgery, particularly when~     their child is in pain. Difficulty with pain control post operatively may delay discharge~     from hospital and parental return to work. It causes disrupted sleep for the child and family~     and may delay the child's return to school. The results of this study will be shared with~     professionals and families at international conferences and in scientific and popular~     (patient-based) publications. This study cannot be undertaken in adults with cerebral palsy~     as they only rarely undergo this sort of surgery.~   "
162594|NCT01437631|"~     The aim of this study is to evaluate the efficacy of prophylactic clip application after~     colonoscopic removal for a large pedunculated polyp (> 1cm) in preventing immediate~     postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB).~   "
162595|NCT01437618|"~     The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as~     first-line treatment could be considered a promising approach to improve the outcome of BRAF~     mutant metastatic colorectal cancer patients~   "
162596|NCT01437605|"~     The overall purpose of this research study is to find a better way to treat melanoma.~      The goals of this study are:~        1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 +~          AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC~        2. To see how well the patient's immune system responds to the MAGE-A3 ASCI treatment with~          or without the Poly IC:LC~        3. To measure the rate of return of the patient's tumor after the MAGE-A3 ASCI treatment~          with or without the Poly IC:LC~        4. To measure the rate of return of the patient's tumor in two groups of patients: one~          group positive for the gene signature, and the other group not positive for the gene~          signature in their tumor after the MAGE-A3 ASCI treatment with or without the Poly~          IC:LC.~   "
162597|NCT01437592|"~     This trial was conducted in Asia. The aim of this trial was to investigate the~     pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250~     (insulin degludec) in healthy Chinese subjects.~   "
162598|NCT01437579|"~     The etiology of bladder pain syndrome is unknown. Therefore the management is directed to~     pain relief, as bladder pain is believed to drive both voiding frequency and nocturia.~     Botulinum toxin A has been shown to decrease noxious input. Several studies showed efficacy~     of botox for treatment of painful bladder.~      The aim of this study is to evaluate the efficacy of Botulinum toxin in patients who are~     suffering bladder pain syndrome with Hunner lesions during cystoscopy.~   "
162599|NCT01437566|"~     This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase~     II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC)~     who have experienced recurrence or progression of their disease while receiving aromatase~     inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI~     therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have~     received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of~     this study. Part I of the study will assess the effect of the addition of GDC-0941 to~     fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS)~     compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and~     tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D)~     on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with~     an AI and whose tumors contain a PIK3CA mutation.~   "
162600|NCT01437553|"~     The iWONDER trial has the following objective:~      To analyze the morphological, phenotypic and tissue characteristics of atherosclerotic~     plaques angiographically considered culprit and not-culprit in patients undergoing~     coronary angiography due to STEMI (ST-elevation myocardial infarction).~   "
162601|NCT01437540|"~     The purpose of this study is to assess the long-term safety and tolerability of inhaled~     aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive~     pulmonary disease (COPD).~   "
162602|NCT01437527|"~     The purpose of the study is to test a new procedure of body image therapy in anorexia~     nervosa, using the anamorphic micro software.~   "
162603|NCT01437514|"~     The local recurrence of rectal cancer is one of the main problem that fail the treatment. The~     preoperative neoadjuvant (chemo)radiotherapy has been confirmed to reduce the local~     recurrence rate,especially in the advanced rectal cancer. However the local recurrence rate~     is low about 10-20% totally,and the integrity of the mesorectum after the operation and~     circumferential resection margin(CRM) are the most critical factor for the local~     recurrence.So that, the advanced rectal cancer patients with negative CRM and had a complete~     mesorectum excision,may not benefit from the neoadjuvant radiation.This trial was mainly~     focus on the resectable advanced rectal cancer patients whose preoperative stage was cT3/N+.~     These patients will be divided into the lower risk group and higher risk group according the~     preoperative CT,Endoscopic ultrasound, and MRI,and carrying out randomized trial in the two~     groups respectively.The purpose of this trial is to confirm whether the preoperative~     radiotherapy is necessary for all the advanced rectal cancer patients,identify the reason of~     the local recurrence,and finally help the making of the treatment decision for the advanced~     resectable rectal cancer.~   "
162604|NCT01437501|"~     This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be~     conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships~     will be screened and three hundred eligible individuals will be enrolled in the study.~     Participants will be randomized into two treatment groups: one will receive a juice beverage~     containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice,~     lime juice, and water and the other will receive a placebo beverage containing pineapple~     juice, lime juice and water. Participants will drink their assigned beverage every evening~     and provide biweekly urine samples and monthly blood samples. The principal endpoints of this~     study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their~     metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of~     exposure biomarkers for dietary and air-borne toxins, which are known to be high in this~     population.~   "
162605|NCT01437488|"~     There is no accepted standard chemotherapy approved for use in the second line for patients~     with advanced urothelial carcinoma whose cancer has progressed on combination chemotherapy~     including either cisplatin or carboplatin. The chemotherapy class called taxanes, either as~     single agents or in combination, have demonstrated modest efficacy in small studies.~     Cabazitaxel is an agent in the taxane family designed to be active in the setting of acquired~     multi-drug resistance that arises in some tumors. The objective of this study is to evaluate~     the safety and efficacy of this agent in patients with urothelial carcinoma refractory~     compared to combination platinum based chemotherapy.~   "
162606|NCT01437475|"~     HBV vaccination is of paramount importance among HIV positive persons due to an increased~     risk of infection and disease progression. The most widely used ENGERIX B vaccine reaches a~     lower rate of vaccination (20-70%) among HIV positive vaccinees (compared to over 90% in the~     normal population). Sci-B-Vac is novel vaccine containing 3 antigens and is therefore more~     immunogenic (as opposed to one in ENGERIX B). Its use has been associated with higher and~     more rapid vaccination rates. Therefore, it has a theoretical advantage in HIV positive~     individuals.~   "
162607|NCT01437462|"~     The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not~     proven in a large-scale study. The researchers aim to provide an investigation that has~     sufficient power to clarify the potential effect of anaesthetic method on postoperative need~     of opioids. Sevoflurane and propofol will be compared.~   "
162608|NCT01437449|"~     Docetaxel and cetuximab are FDA approved for the treatment of squamous cell carcinoma of the~     head and neck. Cisplatin and carboplatin, while not FDA approved for Squamous Cell Carcinoma~     of the Head and Neck (SCCHN), have been used as standard of care in patients with SCCHN in~     combination with other drugs. This study will determine if weekly cisplatin and docetaxel, in~     combination with cetuximab, will be effective in palliative treatment of patients with~     squamous cell carcinoma of the head and neck. These drugs will be given intravenously weekly,~     repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse~     events.~   "
162646|NCT01436955|"~     This multi-center, randomized double-blind, placebo-controlled study will assess the safety~     and tolerability of RG1662 in individuals with Down Syndrome. Eligible subjects will be~     randomized in cohorts to receive either multiple oral doses of RG1662 or placebo. Anticipated~     time on study treatment is 38 days.~   "
162609|NCT01437436|"~     Obesity is associated with increased risk of surgical complications. Ventilation tube~     insertion is one of the most frequent surgical procedures performed on children. However, the~     impact of obesity on surgical results or surgical related complication following ventilation~     tube insertion remains poorly understood. The aim of this study was to investigate the effect~     of obesity on the surgical results of ventilation tube insertion for otitis media with~     effusion (OME) in pediatric patients.~   "
162610|NCT01437423|"~     The purpose of this study is to assess the safety of TETRAXIM™ administered in routine~     clinical practice according to Korea Food and Drug Administration Notification No. 2009-46~     Basic standard for reexamination of new drug based on the pharmaceutical law in Korea.~   "
162611|NCT01437410|"~     The aim of this retrospective single center study was to evaluate the clinical utility of~     histological and immunohistochemical analyses of specimens obtained by endoscopic~     ultrasound-guided fine needle aspiration (EUS-FNA).~   "
162612|NCT01437397|"~     The purpose of this Phase III study is to assess the maintenance bronchodilator effects of~     the fixed dose combination versus monotherapies. This study will also assess the effects of~     the fixed dose combination in terms of COPD symptoms, disease related health status and the~     long-term safety and tolerability of the fixed dose combination. This study will include a 24~     week treatment period, preceding by a run-in period, followed by a two week follow up visit.~     All patients will be randomized to one of four treatment arms or placebo.~   "
162613|NCT01437384|"~     36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete~     the entire study. The study will consist of a pre-treatment phase and a treatment phase. The~     pre-treatment phase will include screening and baseline period 1. The treatment phase~     consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral~     dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose;~     Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 - concomitant~     administration of cyclosporine and the fourth E5501 dose. A baseline period will precede each~     treatment period. The screening period will be up to 13 days in duration. After fulfilling~     screening requirements, subjects will check into the clinic on Day -1 for baseline~     assessments. They will be domiciled in the clinical testing facility for 6 days for Treatment~     Periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient~     visits. They will be domiciled in the clinical testing facility for at least 14 days for~     Treatment Period 2 and will return intermittently for study procedures for 7 outpatient~     visits.~   "
162614|NCT01437371|"~     The purpose of this study is to determine if there is an interest to optimize HF (heart~     failure) management in patients over 80 years old. The primary objective is to assess the~     effect of HF (heart failure) optimized management (guidelines of the European society of~     Cardiology (ESC) on Quality of Life (QOL) in aged over 80 year's old at 6 months.~   "
162615|NCT01437358|"~     Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the~     intensive care unit settings, EA should be proposed in critically ill patients, such as~     postoperative or trauma patients, typically. Recent findings also support anti-inflammatory,~     vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA~     safety and feasibility in the intensive care unit settings are still lacking. The purpose of~     this observational prospective study is to describe the safety and feasibility of this~     analgesia technique in ICU patients.~   "
162616|NCT01437345|"~     This study is an observational study that aims to advance our knowledge on infantile onset~     FSHD. The study will include 50 participants of all ages who have presented with symptoms of~     FSHD between birth and 10 years of age. Study participation will involve a single day of~     assessments at one of the participating CINRG centers (to include physical exam, cognitive~     testing, eye exam, hearing test, strength testing and speech evaluations). The procedures may~     be split over additional days for scheduling purposes.~   "
162617|NCT01437332|"~     Specific proteins and other signaling molecules are increased and decreased following nerve~     injury. Some of these are important in producing pain or explaining why pain persists after~     traumatic nerve injuries or in disease states such as diabetes. In this study, the~     investigators hypothesize that it is possible to detect changes in specific signaling~     molecules and that these will provide insights into novel treatment strategies. The patients~     to be included are those who are undergoing the removal of tissue during surgery. The tissues~     that would otherwise be discarded will be included in the study as appropriate.~   "
162618|NCT01437319|"~     The purpose of this study is to determine if the formation of mucin balls is a marker for~     protection from inflammatory events to the cornea and if mucin balls play a role in~     protection during extended contact lens wear.~   "
162619|NCT01437306|"~     The objective of this single-dose, open-label, randomized, two-period, two-way crossover,~     food-effect study is to evaluate the effect of food on the rate of absorption and oral~     bioavailability of a test formulation of lofexidine 400 μg (2 x 200 μg tablet) manufactured~     by US WorldMeds, LLC.~   "
162620|NCT01437293|"~     An inpatient safety study to characterize the cardiovascular and behavioral effects of~     cocaine administration in the presence of LCE. The proposed study involves an inpatient stay~     of 12 days during which participants will have two cocaine-administration sessions, each~     including five doses of smoked cocaine with ascending doses.~   "
162621|NCT01437280|"~     Oncolytic viruses are viruses that can be found in nature, but they have been modified so~     that they can no longer multiply in normal cells. These viruses infect cancer cells and~     kill them. Once the cancer cell dies thousands of the viruses are released and can~     potentially infect other cancer cells in the area. The effects of oncolytic viruses on the~     tumor are felt to be the result of a combination of the oncolytic viruses directly killing~     the tumor cells as well as the patient's immune system killing cancer cells that are infected~     with the oncolytic virus.~      Modern oncolytic viruses have been used for treatment of thousands of patients. The safety of~     such treatments has been good and there have been no deaths caused by treatment with~     oncolytic viruses. Many patients have benefited from the treatment in the sense that their~     tumors have stopped growing, become smaller or even completely disappeared. Some benefits are~     temporary, but about one third of patients seem to gain longer lasting benefit likely to~     impact survival. The effect of oncolytic viruses on improving survival has not been~     demonstrated yet.~      Oncolytic viruses can be created from many different types of viruses. In this study the~     investigators are using an oncolytic virus created from an adenovirus. Adenoviruses are the~     types of viruses that cause the common cold and the flu. Because replication in normal cells~     does not take place, these oncolytic viruses should not cause any diseases in normal cells.~     Further, to date there has been no incidence of passing the virus on to other humans from~     patients who were treated with oncolytic viruses.~      The purpose of this study is to see the highest dose of CGTG-102 (the oncolytic virus being~     used in this study) that can safely be given to subjects. The investigators will also~     evaluate whether or not the CGTG-102 is helpful in reducing the size of the cancer and~     improving patient survival.~   "
187687|NCT01107873|"~     The purpose of this study is to determine the changes of Dorsalis Pedis Artery Flow Pattern~     after Caudal Block in Children: Observational Study Using a Duplex Sonography.~   "
162623|NCT01437254|"~     The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant~     validation in the independent expert review conducted by Natural Resources Canada (NRCan) in~     the follow up to the Chalk River crisis. The University of Alberta's Edmonton PET Centre and~     the Edmonton Radiopharmaceutical Centre is a cyclotron / radiopharmacy unit, providing a~     safe, cost effective, unsubsidized, and reliable supply of radiopharmaceuticals to hospitals~     and clinics in Edmonton and northern Alberta. A Phase I study is proposed to show safety of~     CPERT as well as comparability with generator-produced Tc-99m pertechnetate (GPERT) in~     subjects with well differentiated thyroid carcinoma post-thyroidectomy and prior to planned~     I-131 Iodide treatment.~   "
162624|NCT01437241|"~     The purpose of this study is to evaluate the virological and clinical efficacy of etravirine~     plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) in HIV-infected~     patients. Additionally, the safety of these regimens, specially lipid profiles, will be~     assessed.~   "
162625|NCT01437228|"~     Cesarean delivery rates are increasing in Turkey and a major component of this increase is~     cesarean on demand. Although data on the rate of cesarean delivery in Turkey is limited, a~     national study reported a rate of 23.8%. Infectious morbidity, consisting primarily of~     endomyometritis and wound infection, remains a leading cause of postoperative complications.~     Estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and~     obstetric variables. Infection following cesarean delivery results in not only increased~     hospital stay but also increases the cost of care. Strategies to minimize postoperative~     infectious and other morbidities have included modifications of surgical technique, changing~     of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and~     altering the uterine position during repair of the uterine incision. Despite these~     interventions, endometritis is still major problem after cesarean delivery.~      Endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing~     an important role. The microbes endogenous to the vagina change throughout the course of~     pregnancy and parturition. Larsen and Galask noted that anaerobic species located in the~     vagina increase dramatically by the third postpartum day. In many cases, the surgeon's hand,~     reaching below the infant's head or presenting part, is in direct contact with the vagina.~     Vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95%~     confidence interval [CI] 58%, 100%) of cesareans that follow labor. In these cases, vaginal~     flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision.~     Vaginal preparation has been shown to decrease the quantitative load of vaginal~     microorganisms as well as to remove certain species of bacteria.~   "
162626|NCT01437215|"~     The purpose of this study is to determine whether the Endologix fenestrated stent graft~     system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic~     aneurysm.~   "
162627|NCT01437202|"~     This is a multicenter, retrospective, observational study to validate a pharmacogenetics~     model for imatinib metabolism and resistance in patients with chronic myeloid leukemia among~     patients in different independent cohort.~   "
162628|NCT01437189|"~     The aim of this open-label, self-control study is to evaluate the efficacy of sertraline in~     treating depression in Patients with Parkinson's disease. In addition, the investigators also~     want to find out whether patient gets better quality of life when depression is improved.~   "
162629|NCT01437176|"~     The purpose of this study is to determine whether this new intramedullary fixation is~     effective in the treatment of intertrochanteric fracture.~   "
162630|NCT01437163|"~     The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy~     system configured in a novel product called the TopHat 655 system, for promoting hair growth~     in males and females diagnosed with androgenetic alopecia of the head.~   "
162631|NCT01437150|"~     The purpose of this study is to determine whether this new anatomical locking plate is more~     effective and easy to operate than other plate in the treatment of acetabular posterior wall~     fracture.~   "
162632|NCT01437137|"~     Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has~     been shown in several large observational studies, findings suggest that the smaller-sized~     c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general~     anesthesia in small infants and that they may even be associated with more frequent~     complications than with the facemask and endotracheal tube. The pediatric i-gel is a new~     supraglottic airway device for children. It is made of a soft, gel-like elastomer with a~     noninflatable cuff. Studies about I-gel in adults have been promising, showing an easy~     insertion, high airway leak pressures, and low complication rates with few postoperative~     complaints. The aim of this study is to compare clinical performance of the pediatric i-gel~     and c-LMA in infants.~   "
162633|NCT01437124|"~     The investigators aim to measure the blood levels of certain metals in a group of patients~     all of whom have had a ceramic on metal total hip replacement. This new bearing surface~     (joint) is relatively new and the investigators are currently following up the largest cohort~     in the world. Clinical results are currently excellent at 2 years in all patients, however~     the investigators are mindful of the lessons learned from the high failure rate of several~     designs of metal on metal hip replacements as well as several in vitro reports and one in~     vivo case report of elevated metal levels in this particular implant. The investigators feel~     it is important to measure the metal ion levels in our group to ascertain and compare these~     with reference standards. Once performed the investigators can relate ion levels to function~     and x ray changes and provide useful longterm data to the patients and the wider medical~     community as to whether this bearing surface is safe in the long term or whether it's use~     should be abandoned. This is useful as there are numerous groups implanting this device in~     the UK and in addition it has just been awarded FDA approval in the USA - its use is likely~     to flourish.~   "
162634|NCT01437111|"~     This study will assess the effect of 26 weeks of once-weekly treatment with~     MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600)~     on serum levels of 25-hydroxyvitamin D [25(OH)D].~   "
162635|NCT01437098|"~     The primary objective of the present trial is to demonstrate the effectiveness and safety of~     the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed~     difficult for surgical operation.~   "
164693|NCT01410019|"~     X-linked severe combined immunodeficiency (SCID-X1) is an inherited disorder that results in~     failure of development of the immune system in boys. This trial aims to treat SCID-X1~     patients using gene therapy to replace the defective gene.~   "
162636|NCT01437085|"~     Prostate brachytherapy is an effective treatment option for men with localized prostate~     cancer, with excellent cure rates and a favorable toxicity profile. With the current needle~     insertion technique, seed placement inaccuracy is primarily caused by needle deflection and~     soft tissue deformation, which both occur during the brachytherapy operation. This study will~     accrue 20 patients undergoing prostate brachytherapy implants and acquire a series of~     ultrasound images, video clips and one CT scan.~   "
162637|NCT01437072|"~     This study is conducted in the Middle East, Northern Africa and Europe. The aim of this study~     is to contribute to the design of a simple screening strategy for countries in scope, by~     exploring the association between risk factors and undiagnosed diabetes in a screening study.~   "
162638|NCT01437059|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol~     (LDL-C).~   "
162639|NCT01437046|"~     Only three medications are approved by the Food and Drug Administration (FDA) for the~     treatment of alcohol dependence (AD), namely disulfiram, naltrexone tablets and injection,~     and acamprosate, however treatment success has been inconsistent. Thus, there exists a~     substantial need for discovering ways to provide more effective treatments. Pre-clinical and~     clinical evidence has clearly demonstrated that the noradrenergic (NE) system is involved in~     the neurobiology of AD, thus representing an interesting new pharmacotherapy target and the~     theoretical rationale for this proposal. Consistent with the concept that the NE system may~     represent a new pharmacological target for AD, recent studies have shown that the prototype~     alpha-1 NE receptor antagonist prazosin reduces alcohol drinking in different animal models.~     Furthermore, clinical evidence has also confirmed that prazosin appears to be efficacious in~     reducing alcohol consumption in alcohol-dependent individuals. While prazosin has a~     significant side effect profile and must be taken three times a day, no other α1-blockers~     have been investigated in alcohol research. Prazosin is a short-acting α1-blocker approved to~     treat hypertension (HTN) and benign prostatic hyperplasia (BPH). After the approval of~     prazosin in the 70's, other selective α1-blockers have been developed to treat HTN and/or~     BPH. Among them, doxazosin has shown a more manageable and safer profile than prazosin. In~     fact, doxazosin is a long-acting α1-blocker, thus it is taken only once/day. Doxazosin is~     also less likely to give hypotensive side-effects. Thus, doxazosin is more commonly used in~     clinical practice to treat HTN and/or BPH, than short-acting α1-blockers, such as prazosin.~     Poor adherence to medications and/or side-effects represent important factors limiting the~     effectiveness of pharmacotherapies for patients with AD. If effective for AD, doxazosin may~     represent a simple, manageable and safe medication, which might be more easily transferable~     to clinical practice. However, doxazosin has never been tested in AD. This project is a~     10-week, double-blind, placebo-controlled, between-subject randomized clinical trial with~     doxazosin (16mg once/day) in alcohol dependent (AD) individuals. This study attempts to~     address whether doxazosin is an effective and safe pharmacotherapy for AD.~   "
162640|NCT01437033|"~     Background:~      - Some types of cancer, like cancer of the esophagus, are difficult to detect at an early~     stage. A possible detection method involves collecting breath samples to look for chemicals~     that may be signs of cancer. However, more research is needed to determine how different~     chemicals appear in different breath samples. This study will involve healthy volunteers.~      Objectives:~      - To study chemicals appearing in breath samples of healthy volunteers.~      Eligibility:~      - Healthy volunteers between 30 and 60 years of age.~      Design:~        -  Participants will fast overnight (midnight to morning) and then provide two breath~          samples taken 5 minutes apart.~        -  Breath samples will be collected on days 1, 49, and 98 of the study~   "
162641|NCT01437020|"~     Background:~      - Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The~     parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also~     affect the blood and immune system. One possible treatment for VL involves an experimental~     drug called SCH708980, which may help to prevent the immune system from becoming suppressed~     and worsening the VL. Researchers want to give the drug along with AmBisome(Registered~     Trademark), which kills the parasites, to see if it is a safe and effective treatment.~      Objectives:~      - To study the safety and effectiveness of SCH708980, alone and combined with~     AmBisome(Registered Trademark), as a treatment for visceral leishmaniasis.~      Eligibility:~        -  Individuals 18 to 60 years of who have been diagnosed with visceral leishmaniasis in the~          past 4 to 5 days, are HIV-negative, and are willing to stay in the hospital for 30 days.~        -  All participants will come from and be treated at the Kala-Azar Medical Research Center~          in Muzaffarpur, India.~      Design:~        -  This is a two-part study. Participants will be assigned to only one part of the study.~        -  Participants will be screened with a medical history and physical exam; blood, urine,~          and stool samples, spleen or bone marrow samples; spleen measurements; a chest xray; and~          a heart function test.~        -  Part 1 participants will be separated into two groups: a larger group will have a~          selected dose of the study drug followed by AmBisome 7 days later, and a smaller group~          will have a placebo treatment followed by AmBisome.~        -  Part 2 participants will have either the study drug or a placebo plus AmBisome, based on~          the test results from the Part 1 participants.~        -  All participants will be monitored in the hospital for 30 days, and will have the~          following tests:~        -  Regular blood samples~        -  Urine and stool samples (day 14)~        -  Spleen measurements (days 8, 14, 21, and 30)~        -  Spleen or bone marrow sample (day 30 only). Participants who still have VL symptoms will~          give another sample on day 45.~        -  At 6 months after the start of treatment, participants will have a follow-up visit with~          spleen measurements, blood and stool samples, and possible spleen or bone marrow samples~   "
162642|NCT01437007|"~     Background:~      Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular~     cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas,~     gastric, breast, ovarian, esophageal cancers, cancer with metastases to the liver.) People~     who have tumors that can be removed by surgery live longer than those whose cancer cannot be~     removed. Chemotherapy can shrink some tumors in the liver, which also helps people to live~     longer, and sometimes chemotherapy can shrink tumors enough that they can be removed by~     surgery. However, most chemotherapy drugs do not work well on tumors in the liver. In this~     study we are testing a new drug, TKM-080301, given directly into the cancer blood supply in~     the liver circulation, to see if it will cause tumors to shrink.~      Objectives:~      - To test the safety and effectiveness of TKM-080301 for cancer in the liver that has not~     responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have inoperable cancer that has started in or~     spread to the liver.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests, and imaging studies.~        -  Participants will have a liver angiogram (type of X-ray study) to look at the blood flow~          in the liver and to place a catheter for delivery of the TKM080301.~        -  Participants will have a single dose of TKM-080301 given directly into the liver. After~          the drug has been given, the catheter will be removed. They will have frequent blood~          tests and keep a diary to record side effects.~        -  Participants may have two more doses, each dose given 2 weeks apart. {Before each dose,~          participants will have another angiogram and catheter placement.}They may also have~          liver biopsies to study the tumors.~        -  Two weeks after the third treatment (one full course), participants will have a physical~          exam, blood tests, and imaging studies. If the tumor is shrinking, they may have up to~          three more courses of the study drug.~        -  Participants will have follow up visits every 3 months for 2 years after the last course~          and then every 6 months as required.~   "
162643|NCT01436994|"~     The investigators aim to establish whether biochemical control during anti-thyroid drug~     therapy in young people with thyrotoxicosis varies depending upon whether a 'block and~     replace' or 'dose titration' regimen is used. The investigators will also assess remission~     rates and the frequency of side-effects in the two treatment groups.~   "
162644|NCT01436981|"~     The purpose of this study is to determine the pharmacokinetic of papaverine after~     administration into the artery mammaria interna.~   "
162645|NCT01436968|"~     The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in~     combination with radiation therapy for patients with intermediate-high risk localized~     prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing~     tumor cells in an immune stimulatory environment induces the body's immune system to detect~     and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity~     and lower than expected recurrence rates in previous clinical trials. The hypothesis is that~     ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer.~     Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms~     receive standard external beam radiation therapy. Short-term androgen deprivation therapy may~     be given but is not required.~   "
162647|NCT01436942|"~     Background:~      Exercise is recommended as a cornerstone in the treatment of ankylosing spondylitis together~     with medication. Last years, increased risk of cardiovascular diseases in patient with~     inflammatory diseases is reported, probably caused by inflammation and increased prevalence~     of traditional risk factors. In both healthy adults and other patient groups,~     cardiorespiratory and muscular strength exercises have been shown to have a positive effect~     on inflammation as well as on cardiovascular risk factors. To our knowledge this has not been~     shown in patients with ankylosing spondylitis.~      Objective: The aim of this study is to investigate the effects of a cardiorespiratory and~     muscular strength exercise program on disease activity and cardiovascular risk factors in~     patients with ankylosing spondylitis~   "
162648|NCT01436929|"~     Tuberculosis is a worldwide common infectious disease and effective first line~     anti-tuberculosis (TB) drugs were available such as isoniazid, rifampicin, ethambutol, and~     pyrazinamide. However, anti-TB drugs may induce hepatic injury resulting in discontinuation~     of anti-TB drugs or changing anti-Tb drug regimen.~      Silymarin has been widely studied for the effect on hepatitis and it has been used in~     hepatology.~      Therefore, the investigators hypothesized that prophylactic administration of silymarin with~     anti-TB drugs may decrease the incidence and severity of hepatotoxicity induced by anti-TB~     drugs.~   "
162649|NCT01436916|"~     Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D~     deficiency is also high i.e. 78-96% in different groups of population in north India.~     Observational studies find association between low Vitamin D status and type 2 diabetes~     mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year~     .There is mechanistic support that vitamin D may influence both insulin secretion and insulin~     sensitivity and subsequently T2DM incidence. In general, cross-sectional and prospective~     studies support the role of vitamin D in the prevention of T2DM. This study will be a single~     blind randomized placebo controlled trial to study the effect of oral cholecalciferol in~     insulin sensitivity and secretion in adults with prediabetes who are also vitamin D~     insufficient.~   "
162650|NCT01436903|"~     CavatermTM is a second-generation thermal balloon ablation device in the management of~     menorrhagia. The purpose of this study is to investigate the success (questionnaire) of~     CavatermTM dependent on uterus probe length, especially corpus probe length, which is~     measured during surgery.~   "
162651|NCT01436890|"~     Asthma is a common, chronic inflammatory disease of the bronchial airways, with a reported~     prevalence in most industrialized countries of between 5 to 10 % of the adult population.~     Asthma is clinically characterized by repeated episodes of wheezing, breathlessness, chest~     tightness, and coughing; usually in the presence of variable airflow obstruction that is~     often reversible either spontaneously or with treatment (The Global Initiative for Asthma~     (GINA), 2009).~      Drug treatment of asthma has focused on anti-inflammatory therapy in all but the mildest,~     intermittent cases. Inhaled corticosteroids have been shown to be anti-inflammatory in~     asthma, but chronic use of these agents may be associated with a range of side effects,~     especially at high doses. In asthma, there remains a need for the development of novel~     anti-inflammatory therapies that are at least equally effective and possess a superior safety~     profile in comparison to corticosteroids.~      This is a randomized, double-blind, triple dummy, placebo controlled, parallel group, dose~     ranging study. The study will be conducted in adult patients with a diagnosis of chronic~     persistent asthma with an Forced Expiratory Volume in one second(FEV1) of 50% to 80% of the~     predicted value. Study will enroll 448 patients globally (278 from India) across different~     centers.~      Patients will be recruited after providing written informed consent. After screening and run~     in period, patient will be randomized (patient meeting randomization criteria) in 1:1:1:1~     ratio to receive either one of the three dose regimens of revamilast or placebo.~      The primary objective of the study is to evaluate the effect of revamilast on lung function~     as assessed by Forced Expiratory Volume in one second (FEV1) after the therapy (12 weeks).~     Secondary objective includes area under curve for FEV1, Change in asthma symptoms, patient /~     investigator's global assessments and safety. Patients will be followed for safety and~     efficacy assessment at week 1, 4, 8 12 and 14 after start of therapy.~   "
162652|NCT01436877|"~     The purpose of this study is to assess the safety and efficacy of MediTate Temporary~     Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction~     (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck~     and prostatic urethra under local anesthesia for few days and taken out some 5 days later in~     the doctors office.~   "
162653|NCT01436864|"~     This study is designed to prove and confirm the efficacy and safety of multiple injections of~     human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in~     patients with choroidal neovascularization due to neovascular age-related macular~     degeneration by comparing intravitreal injections of KH902 with sham-injections.~   "
162654|NCT01436851|"~     In a previous study the investigators found that many bakery workers were sensitized to~     storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational~     allergen with clinical relevance has been questioned, and the investigators wanted to~     investigate whether a nasal provocation with a storage mite extract would trigger symptoms~     and objective signs of rhinitis in bakery workers and a control group.~   "
162655|NCT01436838|"~     Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy~     thereby involving safety risks for the patient and influencing health cost-effectiveness.~     This observational study will concentrate upon the role of MS nurses in influencing~     adherence. This study will examine the influence of initial and subsequent periodic nurse~     interviews which aim to improve adherence to Betaferon® treatment.~   "
162656|NCT01436825|"~     OPTIMS is a non interventional validation study of the calculator developed by Bayer for~     clinician's use in the prophylactic treatment by factor VIII of patients with severe or~     moderate Haemophilia A with a severe clinical profile.~      The study takes place during a single visit, at the time of patient enrollment in the study~   "
162657|NCT01436812|"~     The investigators hypothesized that positive end expiratory pressure (PEEP) would increase~     the regional oxygen saturation (rSO2).~   "
162658|NCT01436799|"~     The investigators hypothesized that both propofol and desflurane would decrease the regional~     oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when~     patients are raised to the sitting position.~   "
162659|NCT01436786|"~     Demonstrating the effectiveness of an economical and feasible intervention such as guided~     imagery on factors associated with preterm birth, along with better understanding of pathways~     leading to adverse birth outcomes has tremendous health, social, and financial benefits. This~     project has the potential to significantly advance the field of nursing and knowledge~     development in the areas of maternal stress reduction in African American women and to~     provide scientific evidence of the effectiveness of guided imagery.~   "
162660|NCT01436773|"~     Adventitial vasa vasorum (VV) as well as intraplaque microvessels are known to be associated~     with atherosclerotic plaque vulnerability. Contrast-enhanced ultrasound has been validated as~     a technique to measure the density of VV. Previous studies have demonstrated a relationship~     between identification of VV and relationship to vascular events such as stroke and~     myocardial infarction. No previous study has reported the utilization of contrast-enhanced~     ultrasound identification of VV in the carotid bed as a means of identifying patients at high~     risk for acute coronary events.~      Aims: In this study, the investigators will aim to identify VV and intraplaque microvessels~     along with carotid intima media thickness (CIMT), a known marker for acute coronary events.~     The investigators will attempt to measure the correlation of VV with acute coronary events~     independent of traditional cardiovascular disease (CVD) risk factors and CIMT.~      Methods: 90 volunteers (30 low risk patients, 30 patients with established coronary artery~     disease (CAD), and 30 patients with recent acute coronary syndrome (ACS)) will be enrolled.~     All patients will undergo contrast-enhanced ultrasound imaging of their carotid arteries and~     measurement of CIMT while obtaining baseline histories and assessment of traditional risk~     factors for coronary artery disease. VV density and CIMT will be measured in all patients.~     Statistical differences in VV among the three groups will be assessed and analyses will be~     made to attempt to identify if VV in the carotid bed is an independent predictor of acute~     coronary events after controlling for CIMT and traditional risk factors.~      Study population: The study population will reflect the patient population of UPMC. No~     individual will be excluded on the basis of race, gender, or ethnicity.~   "
162661|NCT01436760|"~     The goal of the study is to identify possible polymorphisms on the loci of candidate genes~     that may be involved in modulation of pain and inflammation in irritable bowel syndrome.~   "
162662|NCT01436747|"~     The study 'Safety and Efficacy of Paricalcitol for Reduction of Proteinuria in Kidney~     Transplant Recipients' is designed to assess the effects of paricalcitol in kidney transplant~     recipients with proteinuria.~      It is a single centre, randomized, placebo-controlled, double-blind clinical trial that tests~     the hypothesis that 24 weeks' treatment with paricalcitol compared to placebo will result in~     a decrease in urinary protein excretion in recipients of a kidney transplant at least three~     months after transplantation. Additionally, the effects of paricalcitol on albuminuria,~     estimated glomerular filtration rate, and blood pressure will be investigated.~   "
162663|NCT01436734|"~     The aim of the study was to investigate the role of the Trasylol in glucagon prevention in~     degradation using radioimmunoactive method with I125. Additionally different incubation time~     was introduced in human plasma samples after oral glucose stimulation, also in fasted and~     hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the~     techniques for the glucagon measurement are well described nowadays.~   "
162664|NCT01436721|"~     Hepatectomy is one of the best treatments for malignant or benign lesions of the liver. The~     mortality and morbidity rates after hepatectomy have declined in recent years because of the~     precise measurement of liver functional reserve, a better understanding of liver anatomy,~     meticulous haemostasis during operation and improved postoperative management. Although~     surgical techniques have improved, life-threatening complications, such as intra-abdominal~     bleeding, bile leakage and subphrenic infection, now cannot be completed avoided. The local~     complications were most associated with the liver section treatment during the operation.~     Hence, the need for safer and more effective hemostatic treatment than the conventional~     approaches, such as intraoperative pressure by surgical gauze, ligatures, and~     electrocoagulation by mono- or bipolar instruments.~      Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the~     controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood,~     it swells into a brownish or black gelatinous mass which aids in the formation of a clot,~     thereby serving as a haemostatic adjunct in the control of local haemorrhage barriers on~     section.~      The present randomized clinical trial was designed to evaluate the efficacy and safety of~     Surgicel® absorbable Haemostat covering the raw cut surface during the hepatectomy.~   "
162665|NCT01436708|"~     Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction,~     and analyzing the association will be helpful to identify the indication of proper~     management. Therefore, the aim of this study is to identify the above associations.~   "
162666|NCT01436695|"~     Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly~     unpredictable spontaneous seizures. The occurrence of the seizure in patients without any~     forewarning is the most debilitating aspect of the disease.~      The Epicall system is intended for early detection of seizure related life threatening events~     by monitoring per-seizures biomarkers. The system is based on a sticker placed on the side of~     the face. The external sticker incorporates EOG (electrooculograph electrode) and PPG~     (photoplethysmograph electrode) sensors for continuous monitoring of:~        1. Heart Rate (base line, increase, decrease, asystole).~        2. Extra ocular eye movement (blinking, eye deviation, roving eye movements).~   "
162667|NCT01436682|"~     The study investigates assisted nerve blocks using an ultrasound machine.~   "
162668|NCT01436656|"~     CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose~     (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily~     and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic~     melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase)~     and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the~     expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts~     of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion~     part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.~   "
162669|NCT01436643|"~     This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple~     Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin~     reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI)~     antidepressants over 16 weeks as add-on to fingolimod treatment. It is designed to evaluate~     the safety and tolerability of this combination in this patient population based on an~     immunomodulatory treatment with fingolimod.~   "
162670|NCT01436630|"~     The purpose of this study is to investigate the viability of using the Step Test (ST) in~     stroke patients, and to compare the functional performance of the physiologic variables in~     stroke patients during ST and Six Minute Walk Test (6MWT).~   "
162671|NCT01436617|"~     The main objective of this study is to validate the utility of IgE anti-cetuximab in the~     treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab~     (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe~     reactions.~   "
162672|NCT01436604|"~     The main objective of this study is to compare the proportions of late enhancement in~     patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group~     consisting of patients who did not have LV dysfunction after 6 months under the same~     treatment.~   "
162673|NCT01436591|"~     The primary endpoint of this study is to show that this algorithm in high definition is~     superior to the classical algorithm in the diagnosis of lymph node metastases.~   "
162674|NCT01436578|"~     This study will examine the safety and efficacy of posaconazole in general use in Korea.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
162675|NCT01436565|"~     Primary Objective:~        -  To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of~          SAR245408 administered in combination with SAR256212 in adult patients with locally~          advanced or metastatic solid tumors.~      Secondary Objectives:~        -  To characterize the global safety profile of SAR245408 in combination with SAR256212~        -  To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in~          combination~        -  To evaluate the objective response rate (ORR) and tumor volume change (for expansion~          cohort only)~        -  To determine the immunogenicity of SAR256212 as administered with SAR245408~   "
162676|NCT01436552|"~     Background: Dementias (Alzheimer's disease and related syndromes), in their sporadic form,~     have multifactorial origin. Several risk factors (RF) are currently recognized like the~     cardiovascular RF, some genes of susceptibility, but the impact [1] of traumatic life events~     (TLE), considered as psychosocial RF (Persson & Skoog, 1996; Charles et al, 2006), [2] of~     anxiety and/or depression, [3] of the premorbid personality (Clément et al, 2003) with his~     coping strategies, and [4] of the lifestyle (which results from the personality), for the~     moment are still underestimated. Dementia disease can be clinically preceded by a mild~     cognitive impairment (MCI) (Petersen et al, 1996) which is however potentially reversible.~      Purpose: Actually, there is no study concerning the rate of conversion from MCI to dementia~     according to the presence or not of TLE. The aim of this study is to assess association~     between TLE and conversion rate from MCI to dementia.~      Methods: Patients with MCI will be recruited in different memory clinics (Limoges and others)~     Primary outcome: Occurrence of dementia according to DSM-IV-TR criteria in MCI patients~     according to their cumulated score of TLE measured by EVVIE.~      Secondary outcomes: Occurrence of dementia in MCI patients according to various other~     psychopathological factors: anxiety, depression, apathy, personality features, alexithymia~     and resilience levels and life style.~      Study design: Epidemiologic cohort longitudinal and prospective multicenter study.~   "
162677|NCT01436539|"~     The purpose of the study is to evaluate the effects and safety of Adefovir Dipivoxil plus~     polyene phosphatidylcholine compared to Adefovir Dipivoxil alone in patients with chronic~     hepatitis B.~   "
162678|NCT01436526|"~     The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant~     for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary~     embolism (PE) in people undergoing knee or hip replacement surgery.~      The purpose of this study is to establish bioequivalence of 2 immediate-release tablet~     treatments with Rivaroxaban: 2*5 mg tablets and 1*10 mg tablet will be given to healthy~     volunteers under fasting conditions; they will be administered as single oral doses in 2~     periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence~     represents the primary study objective. As a secondary objective, this treatment will be~     assessed in terms of safety and tolerability.~      Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood~     samples of the volunteers will be taken at specific points in time; these samples will be~     analyzed using various statistical methods to establish pharmacokinetic characteristics~     required to compare the 2 treatments. The planned treatments with Rivaroxaban will be~     considered bioequivalent if specific criteria defined in the study protocol are met.~      The study will be conducted in one center in Germany. 28 subjects meeting the inclusion~     criteria will participate. They will be treated according to a single-dose, randomized, 2-way~     cross-over, non-placebo-controlled design.~   "
162679|NCT01436513|"~     The purpose of this study is to assess the bioequivalence and food effect for a new Premarin~     formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal~     women.~   "
162680|NCT01436500|"~     A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult~     patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.~   "
162681|NCT01436487|"~     A study to examine the safety and potential effectiveness of the adult stem cell~     investigational product, MultiStem, in adults who have suffered an ischemic stroke. The~     hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.~   "
162682|NCT01436474|"~     The objective of this proposal is to explore the potential of varenicline as a~     pharmacotherapeutic agent for opioid dependence and addiction.~   "
162683|NCT01436448|"~     Introduction: The overall aim of the study is to assess the efficacy of Lactobacillus~     Rhamnosus in reducing glucose intolerance during and after pregnancy. A second objective of~     the study is to determine the feasibility, compliance and safety of Lactobacillus Rhamnosus~     among this cohort. Within this goal is to determine whether the investigators can enroll~     women at high risk for developing Gestational Diabetes Mellitus (GDM) and follow them out at~     regular antenatal visits and 6-weeks post partum.~      Women with GDM are, 7 times more at risk of developing type 2 diabetes compared with those~     who had a normo- glycaemic pregnancy. The population attributable risk for type 2 diabetes~     mellitus (DM) in women with GDM is high, and around 30 - 50% women with GDM converts into~     type 2 (DM) which is associated with pre-mature morbidity, mortality and high economic~     burden. It is evident that untreated GDM is associated with higher incidence of complications~     during pregnancy and increases the risk of perinatal mortality and infant morbidity. The~     prevalence of GDM in Pakistan is around 8%, comparatively higher than other South Asian~     countries. Therefore, interventions that can improve glucose regulation during pregnancy are~     highly important.~      Probiotics, the live micro-organisms, have shown promising results in regulating glucose~     metabolism among pregnant mice. The effect of Probiotics on glucose metabolism is~     attributable to their immuno-regulatory properties. They elicit powerful anti-inflammatory~     capabilities by inhibiting the NF-kB pathway, which mediates microbial activation of the~     immune system. Further, they diminish both fermentation of polysaccharides and induction of~     fasting-induced adipocyte factor gene transcription. The safety of Lactobacillus Rhamnosus~     among pregnant women is already established in other diseases.~      A placebo controlled trial from Finland on pregnant females randomized to receive either~     dietary counseling and Probiotics (Lactobacillus Rhamnosus), concluded improved glucose~     tolerance as compared to the placebo group [OR 0.31 (95% CI 0.12, 0.78)]. However, this study~     could not determine the sole effects of probiotics in reducing glucose intolerance.~     Nevertheless, no studies on the role of Lactobacillus Rhamnosus in regulating glucose~     intolerance have been conducted in any other part of the world yet. Therefore, a pilot trial~     to see the efficacy, compliance and feasibility of Lactobacillus Rhamnosus among pregnant~     females is imperative. The objectives of the investigators study are:~        -  To assess the efficacy of Probiotics Lactobacillus Rhamnosus (1010 Colony forming Units~          (CFU)/day) in reducing glucose intolerance among pregnant women attending antenatal~          clinic of Karachi-Pakistan.~        -  To assess the feasibility, compliance and safety of conducting a double blind, placebo~          controlled randomized trial of Lactobacillus Rhamnosus by recruiting high risk women~          during pregnancy attending antenatal clinics and following them up 6 weeks postpartum in~          Karachi-Pakistan.~      Methods: For the pilot trial, women will be recruited from antenatal hospital of the city,~     during 12-14 weeks of gestation.~      Study Design: The study will be double blind randomized, placebo controlled trial.~     Randomization will be done by blocked method. The dose of 1010 Colony forming Units (CFU)~     once daily till delivery will be given orally.~      Study Endpoints and Ascertainment: Baseline information will be comprised of socioeconomic~     status, parity, gravida, blood pressure and obstetric history etc. The study endpoint~     comprises of efficacy, feasibility, compliance and safety and will be ascertained at monthly~     follow-up, during week 24 - 28, and 6 weeks post partum. Efficacy will be ascertained by Oral~     Glucose Tolerance Test (OGTT) performed at randomization and during 24-28 weeks of gestation.~     Feasibility and compliance will be assessed through recruitment rate, drop-out rate, reasons~     for drop-out, non-participation and empty drug sachet count.~   "
162684|NCT01436435|"~     The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on~     various lesions types/morphologies.~   "
162685|NCT01436422|"~     Dengue viruses can cause dengue fever and other serious health conditions, primarily~     affecting people living in tropical regions of the world. This study will evaluate the safety~     and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy~     adults.~   "
162686|NCT01436409|"~     The main objective of this study is to compare the rate of fetal extractions between a~     systematic practice of an echography of presentation and the vaginal touch only one usually~     realized during the labor.~   "
162817|NCT01434693|"~     This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and~     7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo),~     double-blind, placebo-controlled study to evaluate the safety of a single dose of oral~     CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's~     Disease.~   "
162687|NCT01436396|"~     The study is designed to evaluate whether the first CYD dengue vaccination can be~     administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit,~     but at 2 different sites of administration.~      Primary Objective:~        -  To demonstrate the non-inferiority of the immune response against Yellow Fever in~          flavivirus (FV)-naïve subjects at baseline receiving one dose of Stamaril vaccine~          administered concomitantly with the first dose of CYD dengue vaccine compared to~          subjects receiving one dose of Stamaril vaccine concomitantly with placebo.~      Secondary Objectives:~        -  To assess the non-inferiority of yellow fever immune response 28 days post-Stamaril~          vaccination based on seroconversion rates regardless of the FV status of subjects at~          baseline.~        -  To describe the safety of Stamaril vaccine administered concomitantly with the first~          dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.~        -  To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine~          administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.~   "
162688|NCT01436383|"~     The trial investigates changes in metabolism during high altitude expedition up to 6865m. A~     mass-spectrometry based platform is used to detect different oxidative stress related~     metabolites. Symptoms of acute mountain sickness are evaluated and correlated with laboratory~     parameters.~   "
162689|NCT01436370|"~     A randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving~     TNF-alpha-inhibitor therapy aged 18 to 64 years of age and healthy gender-and age-matched~     control subjects . This study will investigate the immunogenicity, safety, and reactogenicity~     of two different doses of inactivated trivalent influenza virus vaccine (Sanofi Pasteur~     Fluzone [15 mcg x 3 strains] and Sanofi Pasteur Fluzone High Dose [60 mcg x 3 strains])~     administered intramuscularly in individuals with rheumatoid arthritis receiving~     anti-TNF-alpha (TNFi) therapy and healthy age- and gender- matched controls.~   "
162690|NCT01436357|"~     A two stage, phase I/II, double-blinded, randomized, placebo-controlled study of hepatitis C~     virus (HCV)uninfected male and female injection drug users (IDU) aged 18 to 45. AdCh3NSmut1~     and MVA-NSMut HCV vaccine will be administered to 68 (+/-4) volunteers in stage 1. A planned~     interim analysis of safety and immunogenicity will be conducted. If no safety signal is~     detected and there is evidence of a measurable immune response to HCV then 472 (+/-4)~     volunteers will be enrolled in stage 2. Primary objectives are to 1) assess the safety of~     AdCh3NSmut1 and MVA-NSmut compared to placebo when administered to HCV-uninfected IDUs and 2)~     determine if AdCh3NSmut1 and MVA-NSmut HCV vaccines will reduce incidence of chronic HCV~     infection compared to placebo among HCV-uninfected IDUs. Planned study duration is approx 63~     months (accrual time, 2 months vaccination, 18 months follow-up, and 9 months extended~     observation for subjects becoming viremic in the last month of follow-up).~   "
162691|NCT01436344|"~     With the use of esophageal Holter electrocardiography (eECG), the investigators will look for~     surrogate markers of paroxysmal atrial fibrillation. To do so, the investigators will record~     eECGs in patients with known paroxysmal atrial fibrillation but at the time of eECG-recording~     in sinus rhythm. To identify markers, the eECGs of those patients will be compared to a group~     of controls in sinus rhythm without atrial fibrillation. The investigators hypothesis is that~     it is possible to identify surrogate markers in patients with paroxysmal atrial fibrillation.~   "
162692|NCT01436331|"~     Multi-element interventions for first-episode psychosis (FEP) are promising but have mostly~     been conducted on non epidemiologically representative samples in experimental settings,~     raising the risk thereby of underestimating the complexities involved in treating onset~     psychosis in real world services. The PIANO Trial (Psychosis early Intervention and~     Assessment of Needs and Outcome) is part of a more broad-based research program (Genetics,~     Endophenotype and Treatment: Understanding early Psychosis - GET UP) and aims to: 1) test, at~     9 months, the effectiveness, as compared to treatment as usual (TAU) of multi-component~     psychosocial intervention on a large epidemiologically-based cohort of FEP patients and their~     family members recruited from a 10 million inhabitant catchment area; 2) identify barriers~     that may hinder its feasibility and patient/family conditions that can render this type of~     treatment ineffective or inappropriate; 3) identify clinical, psychological, and~     environmental and service predictors of treatment effectiveness in FEP.~      Study participants will be recruited from Community Mental Health Centers (CMHCs) operating~     for the Italian National Health Service and located in several Northern and Central Regions~     of Italy. The GET UP PIANO Trial has a pragmatic cluster randomized controlled design, which~     is considered the gold standard approach for trials that evaluate complex interventions~     implemented at the institutional level, with the aim of improving health. The assignment~     units (clusters) are the CMHCs, and the units of observation and analysis are the Centers'~     patients and their family members.~      Patients in the experimental group will receive TAU plus: (a) Cognitive-Behavioural Therapy~     (CBT) sessions, (b) psycho-educational sessions for family members, and c) a case manager, to~     serve as the patient's referent. Patient enrollment will take place over a 1 year interval,~     after a 3 month-long piloting. The fidelity of the experimental interventions and the~     characteristics of TAU will be regularly monitored. Several psychopathological,~     psychological, functioning and service use variables will be assessed at baseline and 9 month~     follow-up by independent evaluators. Assuming an expected incidence rate of 17/100.000 per~     year for functional psychoses (as previously estimated in Italy), the investigators expect to~     recruit about 800 patients, and 600 relatives. Assuming an attrition rate of about 50%, the~     size of the trial would detect at 9 months a difference in terms of primary outcome from 25%~     for the TAU arm to 10% for the intervention arm, with a power of 80%.~   "
162693|NCT01436318|"~     Respiratory muscle strength training (RMST) is a potential treatment option that has been~     shown to increase strength and ventilatory function in critically ill patients, patients on~     ventilators and patients with mild neuromuscular weakness. Currently researchers are~     examining the role of inspiratory muscle strength training (IMST) in pressure performance of~     ventilator dependent children with Pompe disease. However, normal pressure-flow-timing~     responses of lung function are not well-characterized in healthy children. The purpose of~     this study is to measure RMST-induced changes in respiratory function in healthy children.~     Children will undergo one session of lung function and strength testing. By studying healthy~     children's respiratory function, this study will also help to develop more efficient~     respiratory muscle training exercise prescriptions for children with neuromuscular weakness~     and impaired respiratory function.~   "
162694|NCT01436305|"~     The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would~     minimize serious long term side effects associated with anti-rejection medications while~     still protecting the new kidney from damage. The researchers also wanted to learn more about~     the safety of this treatment and long term health of the transplanted kidney.~   "
162695|NCT01436292|"~     The purpose of this study is to determine whether 5% human albumin solution, given to correct~     hypoalbuminemia, could improve organ dysfunction in burn patients as assessed by a change in~     the SOFA score from baseline to day 7 (or before if the patient is discharged from the ICU or~     died).~   "
162696|NCT01436279|"~     In this study the investigators plan to compare mifepristone and misoprostol use to osmotic~     dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be~     given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2~     hours prior to abortion. Osmotic dilators are the method currently used in our institution,~     and are placed 24 hours prior to abortion. The primary outcome will be the length of the~     procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure,~     participant's assessment of discomfort before mifepristone or dilators, discomfort during the~     abortion procedure, acceptability to participants, and acceptability to staff.~   "
162697|NCT01436266|"~     Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to~     aid in softening the cervix as well as decreasing blood loss after abortion or vaginal~     delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in~     decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled~     trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester~     surgical abortion decreases blood loss from the procedure. The investigators will also assess~     whether misoprostol improves cervical dilation, changes the length of the procedure, changes~     the need for additional mechanical dilation, changes the subjective ease of the procedure,~     and changes a woman's pain.~   "
162698|NCT01436253|"~     This study is being done to see whether dietary and medicinal measures compliant with~     hyperlipidemia treatment guidelines will result in achieving target lipid values and to~     evaluate the total risk of cardiovascular disease in study participants who have not reached~     satisfactory lipid levels with their current hypolipemic therapy.~   "
162699|NCT01436240|"~     The purpose of this study is to see if questions in English about symptoms that patients may~     have during cancer treatment are understandable when translated into Spanish. These questions~     will later be used in future studies to give a better understanding of patient symptoms.~   "
162700|NCT01436227|"~     The goal of this clinical research study is to learn if pazopanib can help to control Von~     Hippel-Lindau Syndrome VHL. The safety of this drug will also be studied.~      This is an investigational study. Pazopanib is FDA approved and commercially available for~     kidney cancer. Its use to treat VHL is investigational.~      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for~     tumor growth. This may prevent or slow the growth of cancer cells.~      Pazopanib will be provided at no cost to you during this study.~      Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.~   "
162701|NCT01436214|"~     This study is a phase 1/2a, open label, dose escalation and safety study of APC-100~     (2,2,5,7,8-Pentamethyl-6-chromanol) in men with advanced prostate cancer.~   "
162702|NCT01436201|"~     The purpose of this study is to study how the body processes digoxin and the effect of~     dulaglutide on how digoxin is processed by the body. Information about any side effects that~     may occur will also be collected.~      This study is for research purposes only and is not intended to treat any medical condition.~     This research study requires that a blood sample be obtained and stored for future research~     involving genetic analysis.~   "
162703|NCT01436188|"~     The purpose of this study is to investigate changes of cerebral spinal fluid (CSF) proteins~     over time using continuous CSF sampling for 36 hours in elderly healthy volunteers and~     volunteers with mild cognitive impairment or Alzheimer's Disease.~   "
162704|NCT01436175|"~     This study is an optional continuation of previous short-term adult major depressive disorder~     (MDD) augmentation studies. Patients may only take part in this long-term, open-label~     research study if they completed a previous double-blind MDD augmentation study using SPD489.~   "
162705|NCT01436162|"~     This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)~     who are taking certain types of antidepressants but continue to have residual depression~     symptoms. Eligible patients will remain on their antidepressant but will be randomized to~     either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is~     to help answer the following questions:~        -  How safe is SPD489 for the supplemental treatment of depression and what are the side~          effects that might be related to it?~        -  Can supplemental SPD489 help patients who still have residual depression symptoms while~          taking an antidepressant?~        -  How much SPD489 should be given to patients with depression who are also taking an~          antidepressant?~        -  How does SPD489 compare to placebo in depressed patients who are also taking an~          antidepressant?~   "
162706|NCT01436149|"~     This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)~     who are taking certain types of antidepressants but continue to have residual depression~     symptoms. Eligible patients will remain on their antidepressant but will be randomized to~     either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is~     to help answer the following questions:~        -  How safe is SPD489 for the supplemental treatment of depression and what are the side~          effects that might be related to it?~        -  Can supplemental SPD489 help patients who still have residual depression symptoms while~          taking an antidepressant?~        -  How much SPD489 should be given to patients with depression who are also taking an~          antidepressant?~        -  How does SPD489 compare to placebo in depressed patients who are also taking an~          antidepressant?~   "
162707|NCT01436136|"~     This is a cohort study which follows two groups of participants over a 12 months period. One~     group will access a team approach to care with the aim of reducing their cardiovascular~     disease (CVD) risks from a team of doctors, nurses and health care professionals. The other~     group will continue to access standard care from their treating doctor. Both groups will have~     CVD risk score evaluated after a 12 month period.~      The team care approach will involve specific tests to measure CVD risk as well as smoking~     cessation, exercise and dietary advice and support, including monitoring such as blood~     pressure and cholesterol levels~   "
162708|NCT01436123|"~     Intensive therapy with rosuvastatin 40 mg and ApoA-I Milano reduces the total atheroma volume~     (TAV) up to 6.38 or 14.1 mm3 respectively. Our previous bench studies PLASMONICS and NANOM~     First-in-Man trial documented TAV reduction up to unprecedented 79.4 and 60.3 mm3~     respectively with high level of safety and feasibility.~      The completed randomized two arm (1:1) study (NANOM-PCI) with parallel assignment (n=62)~     assessed (NCT01436123) the safety and feasibility of the delivery technique for nanoparticles~     (NP) using micro-injection catheter (with intravascular intramural injection of allogeneous~     stem cells carrying NP after MSCT-, IVUS- and OCT-guided mapping of the vessel), and~     plasmonic photothermal therapy of atherosclerosis combined with stenting (Nano group, n=32)~     versus stenting with Xience V cage (Stenting group, n=30). The primary outcome was TAV at 12~     months.~      The mean reduction of TAV at 12 months in Nano group was -84.1 mm3 (95% CI: SD 28.3; min~     -52.4 mm3, max -99.1 mm3; p<0.05) versus +12.4 mm3 in case of stenting (p<0.05 between~     groups). 42/62 patients (68%) in Nano group passed the Glagov threshold of a 40% plaque~     burden with mean plaque burden (PB) 36.2% (95% CI: SD 9.3%, min 30.9%, max 44.5%). The~     increase of the minimal lumen diameter was 61.2 and 63.3% at 12 month follow up in groups~     respectively. The serial assessment of VH-IVUS showed a significant decrease at 12 months in~     the dense calcium area, fibrous and fibro-fatty tissue with fulminant necrosis due to~     thermolysis in Nano-group, whereas an increase of fibrous and fibro-fatty components in~     stenting arm. We have documented 2 vs 3 cases of the definite thrombosis and 3 vs 5 cases of~     target lesion revascularization in groups respectively. The analysis of the event-free~     survival of the ongoing clinical follow-up shows the significantly lower risk of~     cardiovascular death in Nano group if compare with conventional stenting (93.4% vs 86.7%;~     p<0.05).~      Plasmonic resonance-mediated therapy using noble-metal NP associated with significant~     regression of coronary atherosclerosis. Tested delivery approach has acceptable safety and~     efficacy for atheroregression below a 40% PB.~      The investigators hypothesize that multistep approach with the use of stent in acute care~     unit, and then subsequent transcatheter micro-injection with nanoparticles can resolve~     atherosclerosis, stop and regress atherogenesis, remodulate or even rejuvenate arteries. Stem~     cells in patch can be good carriers for nanoparticles as well as high-effective metabolic~     vectors (paracrine-like regulation of alive cells and via bioactive products of cell lysis~     after detonation of nanoparticles) for the treatment of plaque on site. Gold nanoparticles~     with silica-iron oxide shells promise high-energy plasmonic photothermic burning or melting~     effect under the near-infrared laser irradiation onto the lesion. Thus the investigators~     expect complex two-side effect on the plaque with protected lumen and adventitia.~      Novel discoveries in atherogenesis, and development of nanobiotechnologies with potentials~     for the management of atherosclerosis leads us to the quest of new approaches. The~     investigators still cannot really effectively treat atherosclerosis.~      The investigators management is more symptomatic, and lipid-pool or inflammation-oriented!~     The investigators cannot manage non-organic part (mineral deposits, calcified necrotic core,~     partially collagen and fibrotic tissue) and total plaque volume Surgery and invasive~     procedures is just focused on blood flow restoration (just manipulate the form of plaque) +~     concerns of clinical and technical restrictions (incl. alien body - stent) + risk of~     restenosis or subacute 'fatal' in-stent atherothrombosis + graft survival/ occlusion +~     surgery-related complications High rate of short- and long-term complications and~     readmissions. Regression of atherosclerosis in fact is still a dream. The investigators offer~     an alternative to stenting and may be cardiac artery bypass surgery (CABG). Our approach can~     really allow to rejuvenate arteries, Plasmonic photothermal therapy (PPTT) can burn plaque,~     but stem cells and bioengineered structures promise restoration of the vessel wall.~      Our personal previous data showed that PPTT can 1.6-fold reduce a volume of plaque with most~     optimal long-term result in subsets with the use of SPCs as a delivery approach. The most~     optimal delivery systems of NPs into the plaque are the on-artery bioengineered patch and~     ferro-magnetic approach.~   "
162709|NCT01436110|"~     A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate~     the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate~     inhalation powder in the treatment of asthma in adults and adolescents not currently treated~     with inhaled corticosteroids~   "
162818|NCT01434680|"~     The study was to evaluate the safety and and immune response of each of three lots of~     Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy~     Toddlers.~   "
162710|NCT01436097|"~     Interventions to increase the consumption of fruits and vegetables to date have shown~     promise, but many have limited public health impact due to the lack of scalability of their~     designs. The investigators propose to examine the effectiveness and feasibility of an~     intervention for promoting increased consumption of fruits and vegetables by incentivizing~     their purchase. Collaborating with UpLift Solutions, the investigators will enroll shoppers~     in this Randomized Clinical Trial using the research infrastructure called the Way to Health~     platform. (called the Way to Health platform, and approved as a Prime protocol by the IRB as~     reference # 811860).~      Hypothesis: providing patients with financial incentives can promote healthier behaviors~     (e.g.: eating healthier).~   "
162711|NCT01436084|"~     The goal of this clinical research study is to learn if SB1518 can help to control~     myelodysplastic syndrome. The safety of the drug will also be studied.~      SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain~     leukemias, myelofibrosis, and lymphoma.~   "
162712|NCT01436071|"~     A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study~     to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of~     persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids~   "
162713|NCT01436058|"~     Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage~     in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain~     and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first.~     If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic~     options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells~     have showed the capacity of bone and cartilage regeneration.~   "
162714|NCT01436045|"~     The purpose of this study is to investigate the effect of the rapidly acting intranasal~     insulin derivative (glulisine) on memory and cognition in 12 patients suffering from~     mild-moderate Alzheimer's Disease (AD) using a double-blind placebo-controlled single dose~     study. This study will further assess safety of insulin glulisine as well as the effects of~     this drug on olfaction.~   "
162715|NCT01436032|"~     The purpose of this study is to determine the analgesic efficacy and safety of N1539 in~     subjects undergoing abdominal laparoscopic surgery.~   "
162716|NCT01436019|"~     The purpose of this study is to analyze the frequency of the formation of antibodies against~     three different anti-TNF biologic agents used for the therapy of juvenile idiopathic~     arthritis.~   "
162717|NCT01436006|"~     The situation in Italy regarding radiation dose to patients undergoing Multidetector row~     Computed Tomography (MDCT) scans is unclear despite Italian law require that each centre~     check the Reference Dose Level (RDL) every two years. RDL in CT were first suggested in a~     document of 1998 published by the European Commission (EUR16262/1998) based on the results of~     an older survey in the UK from the late 1980s. Those RDLs, expressed in terms of Computed~     Tomography Dose Index (CTDI) and Dose Length Product (DLP), are reported in the Italian law~     (D.Lgs.187/00). However, in Italy there is no governmental authority comparable to the UK's~     National Radiological Protection Board, deputed to dose evaluation and protection.~      An overview of the Italian situation is relevant in order to know the actual dose levels for~     MDCT administered to patients both adults and paediatrics.~   "
162718|NCT01435993|"~     This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with~     relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital~     signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers of~     health from blood samples), tolerability (any side effects that occur, if any), and~     pharmacokinetics (how the body processes the drug and how long the drug stays in the blood,~     and in cerebro-spinal fluid). The study will also investigate if patients' own immune system~     interacts with GSK1223249.~   "
162719|NCT01435980|"~     Objectives: To investigate the treatment effect between Gastric Bypass and Exenatide in Type~     2 Diabetes in our hospital, in order to investigate the possible mechanism of Gastric Bypass~     and Exenatide.~   "
162720|NCT01435967|"~     The aim of this study is to monitor any impact in the change from the lyophilised formulation~     to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus~     gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due~     to laboratory confirmed rotavirus gastroenteritis in children <=5 years of age, before and~     after introduction of the liquid formulation of the vaccine in Belgium.~   "
162721|NCT01435954|"~     In patients with benign prostatic hyperplasia (BPH), combination therapy with an~     alpha-blocker (AB) and a 5 alpha-reductase inhibitor (5ARI) has been shown to reduce the~     progression of acute urinary retention (AUR) and the incidence of prostate surgery, and also~     provides symptom relief.~      The objective of this study is to compare the likelihood of clinical progression (defined as~     AUR and/or prostate-related surgery) and costs in BPH patients who were treated with delayed~     combination therapy to BPH patients who were treated with early combination therapy using~     data from a United States (US) healthcare claims database. The hypothesis of this study is~     that patients who are prescribed combination therapy early in their BPH treatment will~     experience better clinical outcomes and lower healthcare costs compared with patients treated~     with delayed combination therapy. The null hypothesis is that no difference will be observed~     in outcomes or direct medical costs for patients treated with early combination therapy and~     patients treated with delayed combination therapy.~      The US healthcare claims database includes data from patients with Medicare Advantage as well~     as private health plan coverage including the Impact health plan. About 14 million people~     were covered by this set of health plans in 2007 and were geographically diverse across the~     US. Data from 2000 through 2009 were utilized.~      The study is a retrospective cohort analysis.~   "
162737|NCT01435746|"~     The objective of this trial is to evaluate different transfusion strategies in patients after~     liver transplantation. Patients in the experimental arm will be given red blood cell (RBC)~     transfusion according to a liberal strategy, i. e., transfusions should be given, when~     hemoglobin concentration falls below 10 g/dl, and hemoglobin concentration should be~     maintained between 10 and 12 g/dl. Patients in the control arm will be given red blood cell~     (RBC) transfusion according to a restrictive strategy, i. e., transfusions should be given,~     when hemoglobin concentration falls below 8 g/dl, and hemoglobin concentration should be~     maintained between 8 and 10 g/dl.~   "
162722|NCT01435941|"~     Chronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary~     headache care and is associated with a number of deleterious outcomes, especially higher~     disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined~     as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that~     increase or decrease the risk of developing CM. One factor that appears especially relevant~     is symptomatic medication use. The current study builds upon and expands previous work~     considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use has~     on the likelihood of developing CM.~      This study is a retrospective observational cohort study of data collected via mail survey~     and collated in the American Migraine Prevalence and Prevention (AMPP) database.~      Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a~     longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States~     (US) households were screened and 24,000 individuals who reported severe headaches were~     identified and additional questionnaires have been administered annually. This analysis uses~     data from respondents who meet second edition of the International Headache Classification-2~     (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is~     defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month.~   "
162723|NCT01435928|"~     Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This~     clinical study is designed to test the hypothesis that Lurasidone is effective in the long~     term maintenance treatment of schizophrenia.~   "
162724|NCT01435915|"~     The purpose of this study is to investigate the pharmacokinetic profile of ropinirole PR~     after single and multiple doses of the PR-formulation. It will also investigate the safety~     and tolerability of ropinirole PR after single and multiple doses of PR-formulation.~   "
162725|NCT01435902|"~     The primary objective of this study is to demonstrate that the combination of inhaled~     fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection~     throughout the day against bronchoconstriction induced by exercise compared with fluticasone~     propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with~     persistent asthma.~   "
162726|NCT01435889|"~     The purpose of this study is to assess long term (1 year) respiratory sequelae in children~     surviving an acute respiratory distress syndrome~   "
162727|NCT01435876|"~     This trial aims to determine which treatment modality is better for treatment of the~     convergence insufficiency subtype of intermittent exotropia.~   "
162728|NCT01435863|"~     The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in~     Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).~   "
162729|NCT01435850|"~     Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL~     PLUS (study group).~      We compare primary and secondary stability of both hip stems for radiographic outcome using~     EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.~      Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip~     score and radiographic findings.~   "
162730|NCT01435837|"~     The purpose of the study, Effects of Interaction of Caffeine and Hydration on Voice~     Performance, is to gather information about the effects of caffeine and hydration upon voice~     performance. The research question involves whether systemic hydration may reduce degradation~     on voice performance caused by caffeine ingestion. It is hypothesized that the hydration~     conditions will result in a less degraded vocal performance as compared with the nonhydration~     condition.The investigation involves abstention from any caffeine ingestion for 24 hours -~     from 8pm the day before testing to 8am the morning of testing. In addition, preparation for~     participation involves abstaining from ingesting any foods and liquids for 12 hours - from~     8pm to 8am of the following morning. Each test will take about 10 minutes.~   "
162731|NCT01435824|"~     The investigators propose to study amoxicillin absorption in a 2-stage program that will~     progressively produce, for the first time, information leading to pediatric pharmacology~     recommendations for the administration to children of amoxicillin dissolved in human milk.~     The investigators study will enroll adult volunteers as number of blood extractions, volume~     of blood required and subject availability, among other issues, generate a number of ethical~     and logistical constraints that make it almost impossible to carry such an intensive sampling~     study in infants.~   "
162732|NCT01435811|"~     The purpose of this study is to determine a suitable dose of the human norovirus GII.4~     challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible~     subjects that would be useful for evaluation of vaccines and antivirals.~   "
162733|NCT01435798|"~     This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a~     larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral~     (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord~     injury. Subjects' maximally tolerated doses (MTD) were first determined to establish~     individual dose-analgesic response relationships in a run-in period; following a washout~     period, subjects were then randomized to receive an order of four doses of dextromethorphan~     (including placebo) in a 4x4 Latin square cross-over design.~   "
162734|NCT01435785|"~     Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients,~     pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively~     assessed in this population. The aims of this study are to derive four PKPD models using~     previously published PK parameters sets, and to prospectively assess their performance in~     elderly people. With the obtained data we propose to build a specific PKPD model for this~     population.~   "
162735|NCT01435772|"~     This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion~     every 2 weeks (qow) to patients with late-onset Pompe disease.~   "
162736|NCT01435759|"~     This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)~     who are taking certain types of antidepressants but continue to have residual depression~     symptoms. The purpose of this study is to help answer the following questions:~        -  How safe is SPD489 for the supplemental treatment of depression and what are the side~          effects that might be related to it?~        -  Can SPD489 help patients with depression who are also taking an antidepressant?~        -  How much SPD489 should be given to patients with depression who are also taking an~          antidepressant?~        -  How does SPD489 compare to placebo in depressed patients who are also taking an~          antidepressant?~   "
162740|NCT01435707|"~     There has been no reports of the effect of various kinds of steroid or various dose of~     steroid which are commonly used in the clinical setting. Previous studies have simply shown~     that the blood glucose level is elevated in diabetes patients and did not show or suggest the~     adequate strategy of epidural steroid injection in diabetes patients regarding steroid type,~     dosage or injection interval. Therefore, the investigators tried to evaluate the effect of~     different dosage of triamcinolone, which is a commonly used steroid in epidural steroid~     injection, on the blood glucose level.~   "
162741|NCT01435694|"~     Aims of the study:~      This is a randomized-controlled trial to test the effects of robot-assisted gait training on~     locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait~     impairments. The control group will be treat with conventional physical therapy.~      Subjects and methods:~      60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics.~      Informed consent will be obtained. Participants will be randomized to Robot-assisted gait~     training (experimental group) or conventional therapy (control group) through a randomization~     stratification approach, according to a block randomization of 4.~      The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2~     sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks~     (2 sessions/week), that will focus on gait training.~      Primary outcome measures will be both neurophysiological measures (motor unit firing rate~     characteristics) and clinical test for gait speed (10m walking test). Secondary outcome~     measures will include: clinical tests of walking endurance (six minute walking test), balance~     (Berg Balance Test) and mobility (Up and Go Test).~      Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue~     (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored.~     Subject acceptance and confidence in the treatments will be track with a Visual Analog Scale.~     Outcome measures will be assessed the week prior to treatment initiation (T0), after 6~     sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to~     evaluate treatments retention, by a clinician blinded to the treatment.~   "
162742|NCT01435681|"~     This is a research study using transcranial magnetic stimulation (TMS) to investigate~     interactions between the sensory system and the motor cortex in primary generalized dystonia~     (DYT1 dystonia) subjects who undergo deep brain stimulation (DBS) surgery.~      The sensory system is the body's sense organs - smell, sight, sound, etc. - and the motor~     cortex is the part of your brain where nerve impulses control voluntary muscle activity.~   "
162743|NCT01435668|"~     The purpose of this study is to evaluate the effectiveness of a Brief Motivational~     Intervention (BMI), in reducing alcohol consumption among patients with hazardous or harmful~     drinking admitted in emergency department (ED). Patients aged 16 to 24 and who tested~     positive for blood alcohol content (BAC) of 0.5g/l. or above are enrolled.~      Patients receive either an information leaflet or an information leaflet plus a referral to a~     psychologist. BMI is provided by the psychologist. BMI consists in a first face-to-face~     interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are~     also invited to attend the BMI session. If necessary, patients can be referred to relevant~     care and treatment services for alcohol misuse.~      In a simple blind, randomised controlled clinical trial of 280 patients, 140 patients are~     allocated to the treatment group and 140 to the control group. Randomisation is stratified~     according to patient's age (16-17 or 18-24). Opaque and sealed randomized envelops are used~     for randomisation.~      Alcohol consumption is measured by self-report at 3 months. The principal criteria used to~     assess the reduction of alcohol use at 3 months follow-up is the number of alcoholic drinks~     in the last week. Other events such as ED readmission, quarrels related to alcohol, drinking~     and driving, sexual intercourse without protection will also be assessed. It is the first~     clinical trial in France comparing these two interventions among young patients in ED with~     this design.~   "
162744|NCT01435655|"~     Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.~   "
162745|NCT01435642|"~     This study is conducted in Africa. The aim of this non-interventional study is to evaluate~     the current status of diabetes management, complications and psychosocial aspects for~     children with type 1 diabetes in Algeria.~   "
162746|NCT01435629|"~     This study is conducted in Japan. The aim of the study is to evaluate the efficacy of~     somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia /~     hypochondroplasia enrolled in the GH-1941 study (NCT01516229).~   "
162747|NCT01435616|"~     The purpose of this study is:~        -  To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of~          treatment.~        -  To compare the rate of night time low blood sugar episodes on LY2605541 with insulin~          glargine during 52 weeks of treatment.~        -  To compare the number of participants on LY2605541 reaching blood sugar targets without~          low blood sugar episodes at night to those taking insulin glargine after 52 weeks of~          treatment.~        -  To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after~          52 weeks of treatment~   "
162748|NCT01435603|"~     The purpose of this study is to compare ways of giving advice and providing support to~     improve diet and physical activity in adult primary care patients with elevated body mass~     index and dysglycemia.~   "
162749|NCT01435590|"~     OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to~     diagnostic and patient discomfort.~      METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be~     randomized to endocervical sampling with either a metal curette (endocervical curettage -ECC)~     or and endocervical brush. All samples will be submitted for histological study.~   "
162750|NCT01435577|"~     The purpose of this trial is to established the safety and efficacy of multiple dose~     treatment with tapentadol IV in an adult population with moderate to severe pain following~     bunionectomy.~   "
162751|NCT01435564|"~     The purpose of this pilot study is to estimate the efficacy of a mobile phone based physical~     activity intervention in sedentary men and women.~   "
162775|NCT01435252|"~     Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled~     in this study. Patients are treated with standard chemoradiation in combination with~     concurrent add-on cetuximab. Subsequently patients are randomized to cetuximab consolidation~     therapy (three months, Arm A) versus no consolidation therapy (Arm B). The aim of this study~     is to investigate if cetuximab consolidation therapy improves the 2-year locoregional control~     rate.~        -  Trial with medicinal product~        -  Trial with radiotherapy~   "
162752|NCT01435551|"~     From the past research that has been done the investigators have learned that brain cells die~     & leave a deposit in the brain known as beta-amyloid. Since alzheimer's is a slow acting~     disease the natural immune system does not respond to this illness so this builds up in the~     brain. As it builds up it gets into the neurotransmitters in the brain causing more brain~     cells to die. As these buildups occur dementia sets in due to more of the brain dying &~     effects normal activity.~      STUDY WAS CANCELLED~      Hypnotherapy will be used to do the following things:~        -  Increase the immune system~        -  The immune system will begin to clean up the beta-amyloid buildup~        -  That removes damage cells of the brain~        -  Increase more blood flow to the brain~        -  Allows the active brain cells to be trained to carry out daily activities~      STUDY WAS CANCELLED~   "
162753|NCT01435538|"~     Care pathways are complex interventions to support the interprofessional team in the redesign~     of their care process. This international cluster randomised trial will analyse the impact of~     the development and implementation of care pathways on the interprofessional teamwork.~   "
162754|NCT01435525|"~     The purpose of this study is to confirm the safety profile / factors which impact safety and~     efficacy in patients given triple therapy for Helicobacter pylori eradication with Nexium +~     amoxicillin (AMPC) + clarithromycin (CAM), or Nexium + AMPC + metronidazole (MNZ) in usual~     post-marketing use.~   "
162755|NCT01435512|"~     This is a research study funded by the Department of Defense to test a therapeutic~     intervention for male combat veterans who engage in intimate partner violence (IPV). The~     investigators hope to decrease the recurrence of relationship aggression and help veterans~     manage anger. The primary aim of the study is to test the intervention.~   "
162756|NCT01435499|"~     The primary objective of this study is to evaluate the safety and feasibility of~     administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine~     (melanoma GVAX), alone or in combination with low dose cyclophosphamide (CPM), for the~     adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily,~     the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma~     GVAX, including serological and cellular immune responses in patients treated with either the~     vaccine alone or the vaccine given with low dose CPM.~   "
162757|NCT01435486|"~     Viral bronchiolitis is the most common lower respiratory tract infection of infancy. Apnea is~     a complication of bronchiolitis, reported in 16 - 21% of cases. Caffeine, a~     trimethylxanthine, acts as an antagonist to endogenous adenosine and a potent central nervous~     system stimulant. In apnea of prematurity, caffeine is believed to work by increasing central~     respiratory drive.~      Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September~     2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea.~      A randomized, double-blind, controlled trial with a sample size of 45 patients per group~      Data Collection methods, instruments used measurements:~      Randomization:~      In the emergency department, the patients will be assigned to either one of the two~     treatments using a computer-generated randomized numbers in a 1:1 ratio. Pharmacy will~     prepare sequential sealed vials containing the experimental drugs. Randomization code will be~     revealed only after all patients completed the study. The medical team in addition to the~     patients will be blinded to the medication delivered. There will be no detectable difference~     in the color, smell of the two study treatments.~      Guardians or parents of eligible infants will be approached regarding the study, explaining~     the purpose and the treatment modalities. Patients will be included after obtaining a verbal~     and written consent.~      Study Intervention:~      Treatment 1: Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine~     citrate (25mg caffeine citrate equal to 12.5mg caffeine base).~      Treatment 2: Placebo with an equivalent volume of normal saline. Calculated study medications~     will be diluted with Dextrose 5% in Water to 20 ml and will be given intravenous over 30~     minutes using syringe infusion pump.~      After random assignment, eligible infants will receive one of the study treatments.~     Non-pharmacological therapies may be used as necessary to control apnea. Antibiotics and~     antipyretics may be used as per the discretion of the treating physician.~      After stabilization of patients as usually done in Pediatric Emergency Center , patients will~     be admitted to pediatric intensive care unit (PICU) for further monitoring monitoring when~     indicated.~   "
162758|NCT01435473|"~     Thromboembolic complications (TCs) are important causes of morbidity and mortality after~     pediatric cardiac surgery, resulting in longer hospital stay, increased risk of early and~     late post-surgical complications, early reoperation, neurologic and organ damage, and~     potentially death. The true incidence of blood clots in pediatric surgical patients is~     unknown.~      The overarching objective of this study is to further our understanding of TCs, including~     quantification, characterization and risk stratification. This study will ultimately allow~     the development of effective tools for prevention and early identification of TCs, rather~     than focusing on treatment alone.~   "
162759|NCT01435460|"~     This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%)~     versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief~     of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).~   "
162760|NCT01435447|"~     Allogeneic stem cell transplantation is potential curative therapy for adult acute~     lymphocytic leukemia (ALL). Based on our previous study, the condition with iv-busulfan~     (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation~     mortality and long-term survival is comparable to most data reported with slightly higher~     relapse rate particularly for patients in CR2. In this study, the investigators aim to~     further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell~     transfusion as consolidation for ALL and graft-versus-host disease (GVHD) prophylaxis.~   "
162761|NCT01435434|"~     The study is a prospective, trial to test the safety and feasibility of injecting autologous,~     isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non~     union/delayed fractures. Another objective is to turn this procedure to a standard care~     protocol in our department .~   "
162776|NCT01435239|"~     Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion~     in children. However, it is not proven how much the cuff should be inflated. The aim of this~     study is to compare efficacy between the method using the resting volume and the method using~     half the maximum volume for partial cuff inflation.~   "
162777|NCT01435226|"~     This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451,~     Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in~     Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV)~     Infection.~   "
162778|NCT01435213|"~     The purpose of this study is to validate [11C]ORM-13070 as an alpha2C-adrenoceptor imaging~     agent for human positron emission tomography (PET) studies of brain alpha2C-adrenoceptor~     occupancy.~   "
162779|NCT01435200|"~     Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients~     receiving platinum based chemotherapy than oral iron?~   "
162762|NCT01435421|"~     Acute liver failure (ALF) results from an abrupt loss of hepatic metabolic and synthetic~     function and leads to encephalopathy and potentially multi-organ dysfunction. Aetiologies~     include autoimmune and metabolic diseases, infectious agents and hepatotoxins. Worldwide,~     infectious hepatitis (A, B and E) is the most common cause. In Western Europe and the USA,~     ALF is most frequently caused by paracetamol intoxication.~      The MBT can produce immediate results to aid in decision making in patients with acute liver~     disease. Such a test may affect decision-making regarding transplantation in this setting,~     facilitate appropriate discharge from critical care to other hospital units and to home,~     provide point of care assessment of therapeutic interventions.~      The BreathID can potentially help in determining:~        -  Parameter to include patients in transplant list (the UNOS 1A group)~        -  Identification that patient deteriorates and needs extended hospitalization/referral to~          ICU/change in management~        -  An addition to the MELD and or other scores to estimate risk in other acute patients~        -  Additional information to that of other commonly utilized prognostic scoring systems~      The primary end-point of the study is to develop a model to predict deterioration of the~     liver disease, which incorporates measurements from the MBT along with other potential~     variables. The data collected will be used to develop a prediction model using data-mining~     methodology (linear and non-linear regression models, binary trees, neural networks, etc…).~     The predictive models may include measurements from the MBT, blood test results, as single~     measurements or as trend over time. The model that will be developed, will attempt to predict~     the disease deterioration vs. recovery accurately, at an earlier time point than the standard~     procedure. A threshold will then be determinate based on adequate sensitivity and specificity~     levels.~   "
162763|NCT01435408|"~     This study focuses on Cardioprotective strategies.~   "
162764|NCT01435395|"~     This is a single-center (Emory University), open-label, single arm, phase I study to assess~     safety and toxicity of bortezomib in combination with bevacizumab and escalating doses of~     temozolomide for patients with recurrent glioblastoma multiforme. Patients requiring~     anti-epileptic medications will have to be at least 10 days off EIAEDs. Only non-EIAEDs are~     accepted.~   "
162765|NCT01435382|"~     This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615~     in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.~   "
162766|NCT01435369|"~     The purpose of this research study is to see if the study drug, CT-011, is safe to give and~     if it helps people with melanoma that has spread to other areas of their body. CT-011 is a~     monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by~     infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab~     instead of by the immune system which then recruit the immune system to help fight cancer~     cells.~      All final eligible subjects will receive an intravenous infusion of CT-011. This study will~     test two dose levels of the study drug:~      Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).~      Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).~      Each group will be given the study drug through an IV (a needle put into a vein in the arm)~     on day 1. After day 1, the study drug will be given every other week. Patients may be given a~     total of up to 27 study drug infusions for about 12 months while they are in the study.~     Approximately 100 patients will participate in this study.~   "
162767|NCT01435356|"~     The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic~     product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the~     bladder. A course of 13 injections will be administered over 27 months.~   "
162768|NCT01435343|"~     Second-line induction therapy with fludarabine, idarubicin, cytarabine,Granulocyte~     colony-stimulating factor (G-CSF) and plerixafor, in patients with relapsed or refractory~     Acute Myeloblastic Leukemia (AML) aged 65 or younger.~   "
162769|NCT01435330|"~     The study will assess the safety, tolerability, drug label and effect in subjects with and~     without insulin resistance.~   "
162770|NCT01435317|"~     Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of~     chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient~     setting.~        -  Identification of early indicators for therapy success~        -  Comparison of different patient groups regarding: tinnitus severity, tinnitus duration,~          level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex~          forms~        -  Representative set of safety data in a broad patient spectrum~        -  Measurement of tinnitus burden (TBF-12 Questionnaire)~        -  Generation of longterm compliance data~   "
162771|NCT01435304|"~     This proposal is designed to mitigate hemodilution (blood diluted with an electrolyte~     solution) and loss of plasma proteins responsible for normal blood clotting as well as~     platelets at the completion of cardiopulmonary bypass (CPB). The Hemobag® system is a device~     qualified by the US Food and Drug Administration (FDA). Many cardiac centers, such as~     Englewood Hospital and Medical Center in Englewood NJ are using the Hemobag® system for~     Jehovah's witnesses and other patients who go to that center for bloodless cardiac surgery~     (cardiac surgery performed without the use of blood or blood products). The system is~     designed to filter excessive water from blood left in the heart lung machine (cardiopulmonary~     bypass) after it is separated from the patient during the performance of cardiac surgery.~     Consequently the likelihood of excessive post-operative bleeding and transfusion with~     allogeneic blood (blood bank blood from donors) is decreased.~   "
162772|NCT01435291|"~     A pharmacokinetics and pharmacogenetics study to complement the current knowledge of~     tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at~     steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on~     tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after~     renal transplantation.~      Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus~     immediate release (Prograf®)~   "
162773|NCT01435278|"~     To date, there is no clinical evidence on the efficacy and safety of Glucosanol in~     maintaining weight loss beyond the study duration of 12 weeks. The rationale for this~     open-label study is to assess the efficacy in preventing regain of loss body weight and~     safety of Glucosanol in subjects who are overweight or obese over a longer period after the~     initial weight loss.~   "
162774|NCT01435265|"~     This is a phase IV randomized, prospective open label study to asses the efficacy of an~     extended nurse eduction program in improving adherence to the prescribed treatment regimen in~     the treatment of moderate to severe psoriasis vulgaris.~   "
162804|NCT01434862|"~     This is a scientific research study that will look at how a closed-loop system and the drug~     Pramlintide may work together to improve blood sugar control in people with type 1 diabetes~     mellitus. Pramlintide is approved by the Food and Drug Administration (FDA) and is given as~     an injection (subcutaneous) that works with insulin to lower blood sugar.~   "
162780|NCT01435187|"~     In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic,~     physiologic and clinical data obtained during the initial hospitalization will predict~     respiratory morbidity as defined by respiratory health care utilization and respiratory~     symptoms, between discharge and 1 year corrected age.~      This protocol describes a collaboratively developed multicenter study of very preterm infants~     from birth through the time of discharge from the Neonatal Intensive Care Unit (NICU) and up~     to 1 year of age, corrected for the degree of prematurity.~   "
162781|NCT01435174|"~     End-stage renal disease (ESRD) patients often develop cardiovascular complications, and~     cardiovascular disease is the leading cause of death in this population. Ranolazine's ability~     to treat angina without reducing heart rate or blood pressure makes it an important option~     for ESRD patients. The hemodialysis clearance of ranolazine is unknown. A single-dose~     pharmacokinetic study is needed to characterize ranolazine and its metabolites in ESRD~     patients on and off hemodialysis. Results of the proposed study will provide initial dosing~     estimates for a follow-up, multiple-dose pharmacokinetic study in this population.~   "
162782|NCT01435161|"~     Different lowing blood pressure strategies have a different clinical efficacies. Blocking the~     angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial~     fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months~     than 30% compared to Nifedipine( Adalat GITS ).~      A total of 160 subjects will be included in two study groups. The Group 1 will receive~     80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS).~     Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and~     24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial~     fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg.~     Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood~     pressure during the study.~   "
162783|NCT01435148|"~     Recurrent major depressive disorder affects about 3−5% of the population. It is anticipated~     that by 2020, depression will be the most common cause of disability worldwide in the 18−55~     age group. About two−thirds of these patients respond to first−line treatment~     (antidepressants). In addition, prolonged administration of antidepressants in patients who~     respond results in remission in 80% of patients per year. However, a significant proportion~     of patients either fail to respond in spite of determined pharmacological treatments,~     electroconvulsive therapy and other treatments or do not achieve sustained remission. The~     personal, psychiatric, medical, social and economic consequences are devastating for these,~     treatment resistant, patients. This investigation aims to evaluate the feasibility of deep~     brain stimulation in patients with treatment resistant depression as a viable alternative to~     ablative neurosurgery.The hypothesis is that some patients will respond to stimulation in one~     site rather than the other and that some patients will respond to double rather than single~     site stimulation.~   "
162784|NCT01435135|"~     The purpose of this study is to assess safety and tolerability of late boost regimens of~     AIDSVAX B/E alone, ALVAC-HIV alone, or ALVAC-HIV/AIDSVAX B/E combination in HIV-uninfected~     participants from RV 144.~   "
162785|NCT01435122|"~     The main purpose of this study is to see whether Axitinib will help prolong the time that the~     patient's carcinoid tumors remain stable, and to examine their treatment response through~     testing. Researchers also want to find out if Axitinib is safe and tolerable.~   "
162786|NCT01435109|"~     Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of pain~     and disability among adults. Many adults with OA have significant pain and functional~     limitations, even though they receive some medical care for their OA. Efforts are needed to~     help adults improve OA-related outcomes. This study will examine three different approaches~     for helping adults manage their OA-related symptoms. The study will compare a patient-based~     intervention (involving exercise, weight management, and cognitive behavioral pain~     management), a provider-based intervention (involving provision of patient-specific~     recommendations for care, based on evidence-based guidelines), and a combination of the two~     interventions, relative to usual care among patients with hip and/or knee osteoarthritis. The~     interventions are relatively low cost and easy to disseminate, with the patient component~     being telephone based. This study will provide novel, valuable information of the~     effectiveness (and cost-effectiveness) of these three interventions in the context of~     real-world clinical settings.~   "
162787|NCT01435096|"~     The purpose of this study was to determine the maximum tolerated dose and the recommended~     dose of BN80927 in patients with advanced malignant solid tumors.~   "
162788|NCT01435083|"~     The objective of this study is to find out what the pharmacokinetic/dynamic (PK/PD)~     characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers~     and children). The main questions the investigators want to answer are:~        -  Are differences related to the pathophysiological factors involved in nocturia?~        -  Are there age/gender/size differences?~        -  Can the investigators identify patients who are likely to develop hyponatraemia?~        -  Can the investigators individualize treatment and reduce risk for hyponatraemia?~      Day 1:~        -  Patient is being hospitalized in the morning~        -  General anamnesis and clinical examination~        -  Uroflow and residue measurements (3x)~        -  Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and~          creatinin~      Day 1-2:~      - In the evening at 20h:~        -  start (with empty bladder!) 24h miction-incontinence-residue registration: urine~          collections every 3 hours (every portion of urine within a period of 3 hours must be~          collected in the same collection device), with: registration of volumes and measurement~          urinary concentrations of Na+, Cl-, osmolality and creatinin~        -  Measurement of blood pressure during 24h~      Day 2-3:~        -  In the evening at 19h (day 2): drink 15mL/kg water~        -  At 20h: take desmopressin melt 120µg + start:~             -  24h miction-incontinence-residue registration: registration of volumes and~               measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7)~             -  Measurement of blood pressure during 24h~             -  Collection of urine:U1 at 19h, U2 at 20h, together with intake of first~               desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2~               after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at~               2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin~               melt intake~             -  Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin~               melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+,~               Cl-, osmolality and creatinin (safety profile)~             -  At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour~               during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and~               creatinin: U8 at 9h, U9 at 10h, U10 at 11h~        -  Patient can go home on day 3, unless he is at high risk for side effects, high-risk~          patients are hospitalized for 7 days~   "
162805|NCT01434849|"~     The purpose of this trial is to see if a topical beta blocker is effective in preventing the~     proliferation of infantile hemangioma.~   "
162819|NCT01434667|"~     This study is intended to examine the impact of receiving a genetic risk assessment for~     Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).~   "
162829|NCT01434537|"~     Evaluation of the AccuVein ® AV 300 vein scanner in clinical routine in a pediatric operation~     room setting for a 4 weeks period. Assessment of usability, anonymous clinical register of~     every venepuncture(age, gender, size, weight, punction site, number of attempts, time until~     successful cannulation, local anaesthesia, general anaesthesia, pain scales: faces pain scale~     und BPS/BPOS).~   "
162789|NCT01435070|"~     Patients attending the University Hospital Coventry UK with a broken wrist requiring an~     operation, will be invited to enter the study. At the first visit, they will have an xray of~     the wrist and will be asked to complete a number of questionnaires. The questions are to~     determine if they normally have pain in the wrist and how well they can perform their daily~     activities. The patient will then have an operation, and the fracture in the wrist will be~     held in the correct position with either a metal plate and screws or wires.~      At 6 weeks following the operation the patient will be reassessed and an xray will be taken.~     At 3 months, 6 months and 12 months after the operation patients will perform tests to assess~     the strength of their grip, pinch and movement of their wrist. In addition they will complete~     the the same questionnaires from their first visit. At the 12 month visit patients will have~     another xray.~   "
162790|NCT01435057|"~     In this project, the investigators will test the hypothesis that predominant (two to three~     times a week 60 min) strength training is more effective in reducing visceral fat mass than~     endurance training in obese patients.~   "
162791|NCT01435044|"~     This study was designed to assess the safety and efficacy of multiple interferon-free~     treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone~     and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over~     12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit~     (sustained virologic response [SVR]) versus risk (safety and resistance).~   "
162792|NCT01435031|"~     A prospective, multi-center, single-arm study to establish the safety and effectiveness of~     the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary~     Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary~     Guide Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective~     percutaneous revascularization of native chronic total coronary occlusions~   "
162793|NCT01435018|"~     This study is being done to compare the safety and efficacy of three combination treatments~     for Kaposi's Sarcoma and AIDS.~   "
162794|NCT01435005|"~     The Breast Cancer and Exercise Trial (BETA Trial) is a randomized controlled trial aimed at~     understanding what dose (or volume) of exercise will best reduce the risk for breast cancer,~     particularly among women who are between the ages of 50-74. The primary aim is to compare the~     effects of a high versus moderate volume exercise intervention on specific biological~     intermediate endpoints for breast cancer in a group of previously inactive postmenopausal~     women~   "
162795|NCT01434992|"~     Although endoscopic findings of H. pylori have been reported in the literature, there is~     still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic~     features alone. Most studies concluded that it is not possible to diagnose H. pylori-related~     gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has~     greatly improved in recent years and the exact examination of gastric mucosa was possible.~   "
162796|NCT01434979|"~     The investigators goal is to monitor and quantify the differential physiologic and biomarker~     responses of controls to standardized exercise under thermoneutral and thermally challenged~     conditions and responses of exertional heat stroke (EHS) subjects under a thermal-challenged~     environment to develop unique bio-signature panels to predict those at risk for exertional~     heat illness (EHI) and guide return to duty following an episode of EHS.~   "
162797|NCT01434966|"~     The purpose of this study is to determine if interventions applied at a distant site,~     lumbopelvic region (manipulation and TENS), have a similar effect as interventions applied~     locally at the knee (TENS) on quadriceps force output and activation as well as reports of~     pain during common exercises in individuals with PFPS.~   "
162798|NCT01434953|"~     The purpose of this study is to find out whether labeling adults with prehypertension has~     negative effects on clinic blood pressure and quality of life 3 months after diagnosis.~   "
162799|NCT01434940|"~     The global aim of our study is to validate eye movement recording as an early differential~     diagnostic tool, in order to discriminate as early as possible between neurodegenerative~     dementias of Alzheimer type and depressive pseudodementias (DPD). The investigators want to~     put forward idiosyncratic oculomotor characteristics of Alzheimer's disease (AD) and DPD~     respectively. Eye movements are sensitive markers of neurological diseases and can be used in~     a variety of clinical neurological syndromes.~      This study compares 3 groups of 98 patients: patients suffering of AD and DPD and healthy~     persons. The patients AD will be recruited in the Memory Centre of Resources and Research of~     Besançon and patients DPD will be selected in the psychiatric department of the University~     Hospital of Besançon. The control participants will be recruited from the entourage of~     researchers and patients. The selection of participants in the 3 different groups is based on~     clinical examinations in psychiatry and neurology and neuropsychological assessments. After~     giving informed consent, patients will be evaluated by a psychiatrist and a~     neuropsychologist. The complete assessment takes 150 minutes.~      After having set up patients, eye movements will be recorded using video-oculography~     techniques. The following tasks are performed: the basic dynamic eye movements (latency,~     hypometric and hypermetric saccades, reaction time, saccade speed, accuracy, pupil diameter)~     will be evaluated by the pro-saccade, anti-saccade and predictive saccade tasks. The~     emotional connotation tasks will be assessed by scan of images pair with emotional~     connotation and portrait analysis. The assessment takes 30 minutes.~      This study will include 3 groups:~        -  an Alzheimer group;~        -  a depressed group;~        -  a control group with healthy persons. The population of this study will be comprised of~          patients over age 60 with a visual acuity over 9/10, not diagnosed with eye disease and~          not neuropsychological sequelae that could disrupt the functioning oculomotor.~      These people will be recruited on a voluntary basis, after notification and consent in the~     research center, the Psychiatry Clinical Department of the University Hospital of Besançon.~     This study was conducted over a period of 36 months.~   "
162800|NCT01434927|"~     The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy,~     in a setting where routine sedation for colonoscopy is standard practice and to characterize~     the subset of patients willing to try and potentially completing an unsedated procedure.~   "
162801|NCT01434914|"~     This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in~     patients with chronic leg ulcers. The study will be conducted at a single center with a total~     of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo~     group.~   "
162802|NCT01434901|"~     Xenin-25 and glucose-dependent insulinotropic polypeptide (GIP) are hormones produced in the~     intestine that are released into the blood immediately after ingestion of a meal. Together,~     these 2 hormones increase insulin release and reduce blood glucose levels. Xenin-25 works by~     increasing acetylcholine release in pancreatic islets. This study will determine if a~     Bethanechol, a drug that is similar to acetylcholine, also increases insulin release and~     reduces blood glucose levels after ingestion of a mixed meal.~   "
162803|NCT01434888|"~     The objective of this study is to investigate the pharmacokinetics, safety and tolerability~     of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC)~     to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy~     volunteers.~   "
162806|NCT01434836|"~     The goal of this project is to train currently major depressed patients on fundamental~     aspects of working memory while the investigators administer transcranial Direct Current~     Stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during these training~     sessions. This working memory training would be performed using adaptive Paced Auditory~     Serial Addition Tasks (PASAT). The effects after two weeks of working memory training~     combined with tDCS or sham placebo (10 sessions) will be measured on different variables,~     each measured at the start and at the end of the two weeks of training. The investigators~     expect the greatest anti depressant results and cognitive enhancements in the group of~     depressed patients that received tDCS combined with working memory training.~   "
162807|NCT01434823|"~     The Hospital of the University of Pennsylvania's Medical ICU (MICU) is implementing a model~     of 24-hour intensivist staffing in September 2011. Funds and resources are not available to~     cover the entire year, only certain weeks will be covered. The investigators propose a~     randomized clinical trial to study the comparative effectiveness of nocturnal intensivist~     staffing in the HUP MICU on patient outcomes. The investigators will be collecting and~     analyzing patient data of all patients admitted to the MICU from September 12, 2011, to~     September 11, 2012.~   "
162808|NCT01434810|"~     The primary objective of this study is to determine the safety and efficacy of filtered~     sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film. The~     subject population will be neonates born at Island Maternity Hospital, Lagos, Nigeria. The~     rationale for conducting the study is that in Nigeria, and other countries that may not have~     effective commercial light devices or have reliable access to electric power to operate them,~     filtered sunlight phototherapy might offer a safe and effective treatment for neonatal~     jaundice. Phase I of the study focused on the safety and efficacy of filtered sunlight~     phototherapy. Phase II of the study was a randomized controlled non-inferiority clinical~     trial comparing the efficacy of filtered sunlight phototherapy with conventional~     phototherapy.~   "
162809|NCT01434797|"~     The study hypothesis is that F-18-FDG PET/CT and microcalorimetry might have a diagnostic~     value in the detection of permanent central venous catheters (PCVC) infection when~     conventional means of PCVC infection detection are non-conclusive.~   "
162810|NCT01434784|"~     The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire~     Lung Cancer 13 (EORTC QLQ-LC13) is considered as a standard instrument to assess the quality~     of life (QL) of lung cancer patients. Since its publication in 1994, major clinical advances~     have been made. The research objective is to develop a revised lung cancer module that (a)~     covers all QL aspects relevant in the context of newly available diagnostic and therapeutic~     options, (b) is applicable in both non-metastatic and metastatic cancers, (c) and covers QL~     aspects that are generally relevant for patients with lung cancer but are missing in the~     original module. This project will comprise the first three project phases according to the~     Module Development Manual (www.eortc.be/qol).~   "
162811|NCT01434771|"~     The purpose of this study will be to compare standard of care invasive methods to an FDA~     approved non-invasive device and a novel wireless non-invasive device, both manufactured by~     Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by~     the novel device to the measurements taken by the standard of care invasive monitors.~   "
162812|NCT01434758|"~     Detection of M. tuberculosis in clinical specimens of children has a low sensitivity because~     specimens are either difficult to collect or contain low levels of M. tuberculosis.~     Diagnostic criteria are non-specific and culture confirmation is challenging, as sputum~     samples are not often obtainable from small children and specimens typically have low yield.~     Although children are typically thought to have paucibacillary disease, they are at greater~     risk for dissemination of TB. This may allow for detection of Mycobacterium tuberculosis from~     other bodily fluids than sputum or gastric aspirate, including blood and urine.~     Unfortunately, little is known about the overall yield from these various specimens. From~     pilot data collected among adults and children in Tugela Ferry, we know that it is feasible~     to collect and test various bodily fluid specimens for TB culture. This study aim to test the~     hypothesis that blood and urine cultures will detect Mycobacterium tuberculosis from children~     suspected of disseminated TB, and that a proportion of these non-sputum bodily fluids will~     detect both drug-susceptible and drug-resistant tuberculosis when sputum or gastric culture~     does not.~   "
162813|NCT01434745|"~     The purpose of this study is to determine if simvastatin improves development and behavior in~     patients with Smith Lemli-Opitz syndrome (SLOS) receiving dietary cholesterol~     supplementation.~   "
162814|NCT01434732|"~     Premature babies are at risk for bleeding in their brains, which can result in developmental~     delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical~     cord immediately after birth is standard, but delaying this procedure allows more of the~     baby's blood to move from the placenta into the baby and prevents head bleeds. However, a~     delay in clamping the umbilical cord is not usually done in very premature babies, because it~     would delay their treatment and they could get cold. Milking the umbilical cord is another~     way to give premature babies more of their own blood while avoiding a delay in treatment.~     Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood~     transfusions, and increase the amount of urine made in the first few days of life.~   "
162815|NCT01434719|"~     This study aim to test the hypothesis that human S.suis infections are associated in time and~     space with outbreaks of Porcine Reproductive and Respiratory Syndrome (PRRS) virus or other~     diseases in pigs.~   "
162816|NCT01434706|"~     The investigators propose to study the impact of nucleic acid amplification testing (NAT)~     screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and~     Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity~     Biotech BED, or Ortho-Clinical Diagnostic Vistros ECi for early HIV infection in conjunction~     with routine rapid HIV testing at HIV counseling and testing sites and venues in the San~     Diego county. The overarching goal of this study is to develop and implement a system to~     identify, notify and engage into care those individuals with recent HIV infection in order to~     better define the HIV and Hepatitis C Virus (HCV) epidemics in the San Diego county and to~     evaluate and characterize HIV transmission dynamics within the San Diego population.~   "
164720|NCT01409668|"~     This study is to evaluate the safety and efficacy of consumption of: L.Ruteri containing~     yogurt, L.Fermentum containing yogurt VERSUS placebo on plasma lipids, as well as~     gastrointestinal microflora distribution in hyperlipidemic individuals.~   "
162820|NCT01434654|"~     Patients infected with Human Immunodeficiency Virus (HIV) are at risk of brain related~     complications despite the use of highly active antiretroviral therapy (HAART). Such~     complications are termed HIV neurocognitive disorders (HAND) and comprise a spectrum from~     asymptomatic neurocognitive impairment (ANI), through mild cognitive impairment (MCI) to~     severe HIV dementia (HAD).~      Prior to HAART approximately 30% of patients with advanced HIV disease had cognitive~     impairment; with HAART the incidence of HAND has decreased but its prevalence increased. The~     reasons for the ongoing development of cognitive impairment in HAART treated patients are not~     clear. They might relate to virus induced brain injury prior to starting HAART, the onset of~     a separate neurological process, toxicity related to HAART, or ongoing viral infection in the~     brain.~      It is clear that the ability of different antiretroviral drugs to penetrate the brain varies~     but what is not established is whether these differences between drugs lead to different~     neurological outcomes. The investigators propose to study HIV infected patients stable on~     HAART for 12 months; subdividing the groups according to the brain penetrance of their drug~     combination. Patients would undergo neuropsychological assessment and MRI brain scan at the~     start of the study and after 12 months.~      Differences in neuropsychological tests and MRI would be sought between treatment groups to~     establish whether HAART with better CNS penetration is associated with better outcome and~     fewer MRI changes.~   "
162821|NCT01434641|"~     This protocol details a novel myocardial perfusion Single Photon Emission Computed Tomography~     (SPECT) protocol wherein patients receive a low-dose (6 mCi) of Tc-99m sestamibi during~     exercise or regadenoson pharmacologic stress and undergo a full-time SPECT acquisition~     processed with Wide Beam Reconstruction (WBR). Immediately thereafter patients receive a~     high-dose (30-35 mCi) of Tc-99m sestamibi at rest and undergo a half-time rest scan, also~     processed with WBR. All enrolled research subjects will undergo both the initial stress and~     subsequent rest scan.~      The radiation exposure associated with this new stress/rest protocol is equivalent to that of~     the conventional rest/stress protocol presently in routine clinical uses at SLRHC.~      Eventually, when and if this novel stress/rest protocol is adopted in routine clinical~     practice, patients with normal stress scans would receive only 6 mCi of Tc-99m sestamibi (331~     mSv in men, 241 mSv in women) and spend only approximately one hour in the Nuclear Medicine~     Laboratory.~      All patients presenting to the Nuclear Medicine Laboratory for evaluation of known or~     suspected coronary artery disease will be candidates for enrollment. Fifty patients~     undergoing treadmill exercise stress and 50 patients undergoing regadenoson pharmacologic~     stress will be enrolled. Pregnant and breast-feeding patients will not be eligible.~   "
162822|NCT01434628|"~     A range of observational and epidemiological studies have shown that the lifetime risk of HIV~     infection can be reduced by 70% through male circumcision.~      Rwanda has a national plan to offer a voluntary male circumcision (MC) program to 2 million~     adult men in 2 years as part of a comprehensive HIV prevention strategy. To achieve this~     goal, the government launched a national study, based on the WHO Framework for Evaluation of~     Adult MC Devices, to assess the safety, efficacy and supremacy of the PrePex™ device when~     compared to surgical circumcision.~      The PrePex device was developed to facilitate rapid scale up of non-surgical adult male~     circumcision in resource limited settings.~      Rwanda validated the aforementioned endpoints via physicians in a Safety and Efficacy Study~     (NCT01150370) and Randomized, Controlled Comparison Study (NCT01284088). The procedure was~     bloodless, required no anesthesia, no sutures and no sterile settings, with 1 AE that was~     managed with minimal intervention.~      Evidence submitted to members of WHO, USAID, UNAIDS and the Bill and Melinda Gates~     Foundation, and WHO audited the study site. The Safety and Efficacy study results were~     published in the JAIDS Journal of Acquired Immune Deficiency Syndromes, Sept 8, 2011, and~     presented in CROI 2011 and AUA 2011.~      To achieve its national catch up campaign with minimal burden to the overly strained health~     system, which lacks physicians and surgical infrastructure, Rwanda needs to task shift the~     procedure to nurses. This study is meant to test the Safety and Efficacy in the hands of~     non-surgically trained nurses from the A1 and A2 cadres.~   "
162823|NCT01434615|"~     The purpose of this study is to (a) characterize the current management of patients with~     systolic heart failure (HF) in South Asia following an educational intervention of current~     guidelines and delivery of disease management tools and (b) to characterize the effect of~     current therapy on clinical outcomes in patients managed by tertiary care centers across~     South Asia. Current therapy includes characterization of the post market performance of any~     market released Medtronic cardiac resynchronization therapy (CRT) or cardiac~     resynchronization therapy plus implantable cardiac defibrillator (CRT-D) system for cardiac~     resynchronization therapy (CRT).~   "
162824|NCT01434602|"~     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and~     best schedule of the combination of everolimus and sorafenib that can be given to patients~     with malignant glioma.~      The goal of Phase 2 of this study to learn if the combination of everolimus and sorafenib can~     help to control malignant glioma. The safety of this combination will also be studied in both~     phases.~   "
162825|NCT01434589|"~     The purpose of this study is to 1) determine the efficacy of manualized Short-term Treatment~     of Internet and Computer game Addiction (STICA), assess 2) the durability of treatment~     response in these patients and 3) the impact on associated psychiatric symptoms, e.g. social~     anxiety and depression.~   "
162826|NCT01434576|"~     The purpose of this study is to evaluate the pharmacodynamics, safety, and pharmacokinetics~     of HGS1025 in patients with moderate to severe ulcerative colitis.~   "
162827|NCT01434563|"~     To determine the prevalence of HIV associated Neurological Disorder (HAND) in a population of~     HIV positive patients within a primary care setting compared with the HIV negative~     population. The investigators aim is to assess the use of optimal screening methods to assess~     HAND. For this the investigators will be comparing the performance of a group of persons who~     are HIV positive and a group of persons who are HIV negative to test their memory and~     concentration abilities over-time.~   "
162828|NCT01434550|"~     The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and~     to find out what effects, good and/or bad, this treatment will have on participants and their~     cancer.~   "
163135|NCT01430520|"~     Pain is a major problem after TKA, especially in patients with high pain catastrophizing.~     Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and~     emotional effect. The investigators therefore investigate the effect of Escitalopram as a~     perioperative analgesic.~   "
162830|NCT01434524|"~     The long-term outcomes of branched-chain amino acid (BCAA) administration in patients~     undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of~     oral supplementation with BCAA on the prevention for the development of liver tumorigenesis~     in patients undergoing liver resection.~   "
162831|NCT01434511|"~     This study is to test whether the study drug (OBI-1) is safe and effective for the treatment~     of serious bleeding episodes in people with congenital hemophilia A.~   "
162832|NCT01434498|"~     This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451,~     Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in~     Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.~   "
162833|NCT01434485|"~     The purpose of this study is to confirm the safety profile / factors which impact safety and~     efficacy of Nexium capsules in daily clinical usage for the patients who have been prescribed~     Nexium for gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis,~     non-erosive reflux disease, or Zollinger-Ellison syndrome~   "
162834|NCT01434472|"~     This phase II trial studies the side effects and how well high-dose yttrium-90~     (Y-90)-ibritumomab tiuxetan (anti-cluster of differentiation [CD]20) followed by fludarabine~     phosphate, low-dose total body irradiation (TBI), and donor peripheral blood stem cell~     transplant (PBSCT) work in treating patients with aggressive B-cell lymphoma that has~     returned after a period of improvement (relapsed) or has not responded to previous treatment~     (refractory). Radiolabeled monoclonal antibodies, such as Y-90-ibritumomab tiuxetan, can find~     cancer cells and carry cancer-killing substances to them with less effect on normal cells.~     Giving chemotherapy, such as fludarabine phosphate, and TBI before a donor PBSCT helps stop~     the growth of cancer cells. It may also stop the patient's immune system from rejecting the~     donor's stem cells. However, high-dose radiolabeled antibodies also destroy healthy blood~     cells in the patient's body. When healthy stem cells from a donor are infused into the~     patient (stem cell transplant), they may help the patient's body replace these blood cells.~     Giving high-dose Y-90-ibritumomab tiuxetan followed by fludarabine phosphate, TBI, and donor~     PBSCT may be an effective treatment for patients with B-cell lymphoma.~   "
162835|NCT01434459|"~     Therasphere is a form of treatment that has been designed to selectively deliver radiation to~     the cancer within the patient's liver. This form of treatment has been used in a number of~     clinical trials and has been approved for use in the treatment of liver cancer.~      The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with~     TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the~     tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic~     cancer or cholangiocarcinoma (bile duct tumors) involving the liver.~   "
162836|NCT01434446|"~     In the late 1990s, researchers discovered that acoustic stimuli slow progressive~     sensorineural hearing loss and exposure to a moderately augmented acoustic environment can~     delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic~     environment could improve age-related auditory changes. These ameliorative effects were shown~     in several types of mouse strains, as long as the acoustic environment was provided prior to~     the occurrence of severe hearing loss.~      In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing~     ability against damage by traumatic noise. In particular, a method called forward sound~     conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce~     noise-induced hearing impairment in a number of mammalian species, including humans.~      Interestingly, recent report has suggested that low-level sound conditioning also reduces~     free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces~     Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased~     cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and~     compound action potentials (CAPs) were measured.~      In addition to forward sound conditioning, backward sound conditioning (i.e., the use of~     acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing~     ability against acoustic trauma and to prevent the cortical map reorganization induced by~     traumatic noise.~      In this study, the investigators examine the effect of sound stimulation on hearing ability~     in human subjects.~   "
162837|NCT01434433|"~     This study will evaluate method correlation and mean bias between six B-type natriuretic~     peptide (BNP) platforms.~   "
162838|NCT01434420|"~     Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high~     histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse~     prognosis than the other forms of breast cancer. It is however a heterogenous group for~     histological and molecular level, but also for evolution. Most of the TN is part of the basal~     breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.~      Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly~     of basal type and their prognostic seems better that what could be expected from high grade~     tumours and without hormonal receptors. They would be much more frequent in the TN group.~     However, at this day, no prospective study was led to estimate this incidence, or to study~     the intervention of other genes of predisposition, as well to analyse the links between this~     phenotype and their consequences at the germinal or somatic level, in terms of associated~     molecular changes and prognosis.~      The purpose of this study is, on a prospective study, to lead a joined analysis at the~     germinal level, in search of mutations of the main genes of breast cancer predisposition~     (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and~     transcriptome), by correlating these results to the main clinical parameters.~      The 5 years relapse-free survival will also be estimated.~   "
162839|NCT01434407|"~     The purpose of the meal study is to investigate acute effects on satiety and inflammation of~     advanced glycation endproducts (AGE) in healthy overweight subjects. The AGE content of the~     meal is affected by food preparation methods: frying/grilling versus boiling/steaming.~   "
162872|NCT01433978|"~     Core study:~      To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in~     addition to standard of care) for the treatment of adult participants with chronic immune~     thrombocytopenia (idiopathic thrombocytopenic purpura [ITP]) as measured by durable platelet~     response.~      Open-label Extension Phase:~      To evaluate the safety and tolerability of long-term therapy with avatrombopag in~     participants with chronic ITP (cITP).~   "
162840|NCT01434394|"~     EGFR is a potential target for new anticancer therapy in head and neck squamous cell~     carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the~     stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced~     apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is~     that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally~     advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of~     this study are the pathological complete response after neo-adjuvant Erbitux-based~     chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.~   "
162841|NCT01434381|"~     Background:~      - The malaria vaccine Pfs25-EPA/Alhydrogel may help block malaria parasites from developing~     in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent~     parasites from developing in the mosquito. As a result, the mosquito will not spread malaria~     to the next person it bites. However, the vaccine will not directly prevent people from~     getting sick with malaria. Researchers want to test the safety of and response to this~     vaccine.~      Objectives:~      - To test the safety of the malaria vaccine Pfs25-EPA/Alhydrogel.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests.~        -  They will be assigned to a study group to have either two or three doses of the vaccine.~          Participants will have checkups after each dose of vaccine,~        -  The additional doses will be given 2 months or 2 and 4 months after the first vaccine.~        -  Participants will have regular blood tests to check the level of the response to the~          vaccine.~        -  They will be followed for up to 1 year after the last vaccine to have any additional~          tests as needed.~   "
162842|NCT01434368|"~     Despite the clear importance of adolescence in the emergence of a number of disease states~     and processes, there is surprisingly little known about how the endocrine and metabolic~     events accompanying puberty in humans impact normal developmental neurobiology. Epidemiologic~     studies have identified sexual dimorphisms in the prevalence of several neuropsychiatric~     disorders, including depression, schizophrenia, and substance abuse. Many of these sex~     differences emerge during or shortly after puberty and are maintained until the 5th-6th~     decade of life. For example, the two-fold greater risk of unipolar depression in women~     compared with men does not appear until adolescence, and prior to puberty girls are not at~     increased risk relative to boys. Puberty is a structured, transitional process that can be~     influenced by both nutritional factors and environmental stressors; nonetheless, the~     variability in the timing and duration of puberty is largely determined by oligogenic~     inheritance. Basic neuroscience research has demonstrated that hormonal events accompanying~     puberty impact on many of the physiologic systems involved in the regulation of brain~     function (e.g., the appearance of new neurons in a brain-region specific pattern, neuronal~     remodeling, and the pruning of cortical connectivity). Additionally, not only does stress~     during puberty increase the risk of disturbances in affective adaptation during adulthood,~     but the events accompanying puberty modify stress responsivity (e.g., alterations in the~     duration and peak response of hypothalamic-pituitary-adrenal [HPA] axis hormones to~     stressors). Moreover, animal work has demonstrated that neural connectivity differs in a~     brain regional specific manner according to the stage of puberty (i.e., early versus late).~     In humans, puberty also occurs in stages, and although the endocrinology of puberty,~     surprisingly, has not been fully characterized with longitudinal data, studies have~     documented that the physical changes measured by Tanner stages I to V are accompanied by~     progressive increases in the secretions of both gonadal and adrenal steroids. Nonetheless,~     there remains considerable variability in the timing and duration of this otherwise highly~     structured reproductive transition.~      We propose to perform a longitudinal, naturalistic study examining changes in brain structure~     and function, behavior, and stress responsivity in boys and girls across the pubertal~     transition. Because the pubertal transition is defined by a complex series of physiologic~     events that emerge sequentially over several years and involve changes in multiple endocrine~     and growth systems, and because there is also considerable variability in the timing of these~     events reflecting the influence of both genetic and environmental factors, puberty cannot by~     delineated by age of the participants as has been done in most imaging and other~     neurobiological studies of adolescence. The present study will formally bridge this gap by~     defining pubertal events per se in participants.~      Participants will include healthy boys and girls whose pubertal status will be assessed, and~     in whom endocrine, metabolic, and brain imaging measures will be evaluated at eight - ten~     month intervals from age eight years (pre-puberty) until age 17 years (post-puberty).~     Reproductive endocrine, metabolic, and physical measures will be employed to characterize the~     stage and duration of pubertal development. Outcome measures will be derived via multimodal~     neuroimaging techniques, cognitive/behavioral assessments, metabolic measurements, and~     evaluations of HPA axis function. Additionally, the impact of genetic variation on the~     developmental trajectory of these parameters (both reproductive and CNS) will be determined.~      This cross-institute proposal will employ a multidisciplinary approach to evaluating the~     effects on CNS function of the process of puberty in both boys and girls. This work will not~     only serve to inform research on the mechanisms by which sexual dimorphisms in~     neuropsychiatric disorders develop, it will also have important implications for the~     prevention and treatment of these disorders.~   "
162843|NCT01434355|"~     This research trial studies deoxyribonucleic acid (DNA) samples from younger patients with~     germ cell tumor and their parents or siblings. Studying samples of tumor tissue and saliva~     from patients with cancer in the laboratory may help doctors learn more about changes that~     occur in DNA and identify biomarkers related to cancer.~   "
162844|NCT01434342|"~     RATIONALE: Continued smoking after a cancer diagnosis has important health consequences~     beyond the risks associated with smoking in the general population. Smoking reduces the~     efficacy of cancer treatments including surgery, radiation and chemotherapy. Despite the~     negative consequences, it is estimated that between 15-75% of patients with cancer continue~     to smoke after their cancer diagnosis. Lung, breast, prostate, colorectal, bladder, head &~     neck, and cervical cancer patients were chosen because there is evidence of potential~     clinical benefit associated with quitting smoking in all of these populations and they~     represent a mix of both smoking and non-smoking related cancers.~   "
162845|NCT01434329|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients respond to~     treatment.~      PURPOSE: This research trial studies DNA in samples from patients with acute myeloid~     leukemia.~   "
162846|NCT01434316|"~     This phase I trial studies the side effects and the best dose of veliparib and dinaciclib in~     treating patients with solid tumors that have spread to other places in the body and usually~     cannot be cured or controlled with treatment. Veliparib and dinaciclib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
162847|NCT01434303|"~     This phase I trial studies the side effects and best dose of entinostat when given together~     with lapatinib ditosylate and trastuzumab in treating patients with breast cancer that has~     spread from the original (primary) tumor to distant organs or distant lymph nodes or has~     recurred (come back) at or near the same place as the original (primary) tumor, usually after~     a period of time during which the cancer could not be detected. Entinostat and lapatinib~     ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor~     cells to grow and spread. Giving entinostat together with lapatinib ditosylate and~     trastuzumab may kill more tumor cells.~   "
162848|NCT01434290|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways~     may kill more tumor cells.~      PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in~     treating patients with prostate cancer.~   "
162849|NCT01434277|"~     This study is to evaluate the safety of a new preservative in a lubricant eye drop used four~     times a day in healthy adults and subjects diagnosed with dry eye.~   "
162850|NCT01434264|"~     Energy healing is among the most commonly used forms of complementary and alternative~     medicine among cancer patients. There are, however, few studies on the effects of energy~     healing for cancer and cancer associated symptoms and none of them are of a volume or quality~     that allows reliable conclusions to be drawn. Qualitative studies on energy healing in~     Denmark have demonstrated that the interventions are individualized and the expected outcomes~     personalized. This research points to the need for a research design that can evaluate~     personalized outcomes of individualized treatments and at the same time adhere to general~     demands of external and internal validity.~      The objective of this study is to test the effectiveness of energy healing as an~     individualized rehabilitative intervention to improve outcomes of personal choice among~     persons who have completed a conventional intended curative treatment for colorectal, breast~     and prostate cancer. The study is designed as a pragmatic clinical trial with personalized~     outcomes.~      The study attempts to maximize external validity by using a design that incorporates~     important features of energy healing administered in real-life settings: 1a) allowing~     participants self-selection to healing and non-healing control, 1b) assessing individual~     participant-selected treatment goals, 1c) allowing the treatment to be performed in the~     private clinics of the healers. To maximize internal validity similar to that obtained in a~     randomized, clinical trial design, the study will 2a) randomize participants to~     self-selection and randomized groups of intervention and control; and 2b) supplement the~     assessment of personalized treatment goals with assessment of outcomes with standardized~     measures.~      The study will account for a number of possible moderators of the effects, including 3a)~     socio-demographics and 3b) previous experience with complementary and alternative treatment.~     Outcome measures will be assessed by questionnaires, physical measurements, data from~     administrative registries as well as semi-structured interviews and participant observation.~     Possible patterns in the various forms of data will be examined for concordances and~     discrepancies.~      Finally, the methods will be discussed in terms of their generalizability as a model for~     evaluating personal outcomes of individualized treatments with high levels of external and~     internal validity.~   "
162873|NCT01433965|"~     The purpose of this study is to determine whether lenalidomide can stop the growth of~     leukemia stem cells and can be used to prevent the return of leukemia cells after a~     transplant.~   "
163235|NCT01429207|"~     The purpose of the study is to test whether body-worn wireless motion sensors can measure~     dyskinesias (involuntary movements caused by medications) in individuals with Parkinson~     disease (PD) independent of voluntary activity being performed and other PD motor symptoms~     (e.g. tremor).~   "
162851|NCT01434251|"~     Hypotension in the very preterm infant (gestational age [GA] <32 wks) is a frequently~     occurring clinical problem. Although no real consensus has been reached on the definition of~     hypotension in these infants, in clinical practice a mean blood pressure (mean BP) in mmHg~     lower than the GA age in weeks is considered to be the starting point for anti-hypotensive~     therapy. However, although an association between neonatal hypotension and mortality/~     morbidity exists, there is no evidence of causality between hypotension (meanBP <GA in~     completed weeks) and neonatal mortality/morbidity. In addition, using mean BP alone as the~     indication of treatment of neonatal cardiovascular compromise without taking into~     consideration the status of tissue perfusion may lead to unnecessary exposure of neonates to~     vasoactive medication. This medication can be potentially harmful to these extremely~     vulnerable patients.~      The aim of this study is to compare neonatal mortality and short-term neurodevelopmental~     outcome (cerebral ultrasound during the first 7 days of life, advanced MRI indices of~     structural brain injury at term GA) and long-term neurodevelopmental outcomes (Bayley scales~     of infant development III [BSID-III] at 24 months) between two groups of very preterm infants~     presenting with hypotension without clinical and laboratory evidence of compromised tissue~     perfusion during the first 3 days of life. Hypotension will be defined as the mean BP (in mm~     Hg) lower than the infant's GA (in weeks). Patients randomized to Group A will be treated~     according to the treatment protocol operative in the Neonatal Intensive Care Unit (NICU) of~     the University Medical Centre Utrecht (UMCU) while Group B will receive no cardiovascular~     support for hypotension unless they have evidence of compromised tissue perfusion and~     end-organ function ((i.e. near infrared-monitored regional cerebral oxygen saturation (ScO2)~     <50% despite optimized ventilatory support and FiO2 administration, plasma lactate >6 mmol/L;~     and/or urine output <0.6 mL/kg/hour) or mean BP >5mmHg lower than the current guideline.~      The investigators hypothesize that there will be no differences between the two groups~     concerning short and long-term neurodevelopmental outcomes.~   "
162852|NCT01434238|"~     The purpose of this quasi-experimental study is to evaluate the effectiveness of an infant~     feeding intervention in improving growth and anemia outcomes among HIV-exposed infants 6-12~     months of age.~   "
162853|NCT01434225|"~     NEMO is a multicentre pan European clinical trial with the aim to develop new treatment~     strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. There~     is evidence that bumetanide improves GABAergic function of the current standard drug,~     phenobarbitone. Bumetanide has been used as a diuretic in term and preterm babies for around~     thirty years. This trial should confirm that Bumetanide in addition to standard treatment~     will result in better seizures control.~   "
162854|NCT01434212|"~     The purpose of this study is to determine whether the outcome of interferon therapy on HCV~     infected patients can be early precisely predicted with a novel mathematic method with~     Chinese population.~   "
162855|NCT01434199|"~     As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more~     and more screening colonoscopies are now being performed for prevention or early detection of~     this fatal disease. Complete colonoscopy as indicated by caecal intubation is essential to~     make it a reliable screening tool for colorectal cancer or polyps. Cecal intubation rate is~     highly variable and dependent on individual experience. Colonic looping is the commonest~     cause of incomplete colonoscopy. Magnetic endoscope imaging (MEI) is a non-radiological~     imaging technique to provide real time, three-dimensional image and position of the~     colonoscope during the procedure. It may facilitate straightening of colonic loops and hence~     cecal intubation.~      The investigators aim to evaluate the benefit of MEI in term of cecal intubation rate across~     endoscopists of all levels of experience by making use of the newly developed Endoscopy~     Position Detecting Unit (UPD-3)by Olympus Optical Co, Ltd, Japan.~      The investigators propose to conduct a prospective randomized controlled trial to compare the~     caecal intubation rate of colonoscopy being performed with and without UPD-3 guidance.~     Colonoscopies performed by endoscopists with different level of experience will be randomized~     to UPD-3 guided group or conventional group (no UPD-3 guidance). Patient controlled sedation~     (PCS) containing propofol and alfentanil will be given to all patients. The investigators~     hypothesize that UPD-3 guided colonoscopy is associated with high caecal intubation rate~     (complete colonoscopy), shorter time to caecum, less patient pain and lower sedative~     medication requirement. A high caecal intubation rate facilitates a reliable colonoscopy~     screening. Decreased colonic looping and shorter time to caecum may reduce patient discomfort~     during the procedure. It may also facilitate learning and acquiring the skill of colonoscopy~     in trainees.~   "
162856|NCT01434186|"~     To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination~     with Metformin in pediatric patients with type 2 diabetes~   "
162857|NCT01434173|"~     Moxifloxacin is a broad-spectrum antibacterial agent used to treat common community-acquired~     respiratory tract infections, complicated intra-abdominal infections, and pelvic inflammatory~     disease. In the clinical development program, moxifloxacin was associated with some hepatic~     adverse drug reactions. To evaluate further the hepatic safety profile of moxifloxacin, a~     retrospective cohort study with nested case-control analysis will be conducted to assess the~     rate of noninfectious acute liver injury among new users of moxifloxacin and of other~     antimicrobials prescribed for similar indications, including amoxicillin, amoxicillin plus~     clavulanic acid, cefuroxime, clarithromycin, doxycycline, levofloxacin, and telithromycin.~      The study will be implemented in the population included in the HealthCore Integrated~     Research Database (HIRD). Eligible patients are adults aged 18 years and older with~     continuous enrollment in the HIRD for at least 6 months before their first claim for a~     prescription for a study antimicrobial. Follow-up will start at the date of the first~     prescription until the date of the earliest of the following events: noninfectious acute~     liver injury, occurrence of an exclusion criterion, end of study period, disenrollment from~     database, or death. Patients with chronic alcoholism or cirrhosis, infectious hepatitis,~     HIV/AIDS, or pregnant women will not be included.~   "
162858|NCT01434160|"~     The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped~     intrauterine contraceptive system in female adolescents under 18 years of age. Approximately~     300 generally healthy, post-menarcheal female adolescents with regular menses at the~     beginning of the study requiring contraception will be enrolled into the study.~      Duration of study treatment is approximately 12 months with an option to continue the use of~     the contraceptive system up to three years if the woman is willing to continue the use after~     the first 12 months.~      The incidence of adverse events over 12 month treatment period will be the main outcome of~     this study. Also the efficacy (number of pregnancies), discontinuation rate and~     pharmacokinetics will be evaluated.~   "
162859|NCT01434147|"~     Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab~     followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma~   "
162860|NCT01434134|"~     Women treated for breast cancer are at increased risk for cardiovascular disease, including~     heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators~     want to assess if heart failure medications such as beta blockers and angiotensin receptor~     blockers can prevent cardiac dysfunction during early breast cancer therapy.~   "
162861|NCT01434121|"~     The major goal of this project is to determine whether intravenously infused ascorbic acid is~     safe for use as a viable therapeutic strategy in adult humans with sepsis.~   "
162893|NCT01433679|"~     The primary purpose of this study is to test whether rewarding physical activity with a~     motivational website will increase physical activity levels in middle school-aged children~     over six months. As a secondary outcome, the study also tests the intervention's impact on~     biological measures of inflammation and metabolic function in a sub-set of study participants~     who agree to provide blood samples.~   "
162862|NCT01434108|"~     The main objective is to evaluate the effectiveness of the experimental drug to reduce plasma~     ammonia concentration at a dose that is safe and well tolerated. Ammonia usually rises~     significantly in the hours after gastrointestinal bleeding in patients with cirrhosis of the~     liver. This increase in the concentration of ammonia facilitates the development of hepatic~     encephalopathy.~      The study will be divided in two parts:~      Part A: Open-label, dose-escalating, single cohort study. The goal of this phase is to~     confirm the tolerance and safety of the dose of OP that is being proposed for the study~     according to the results of phase I and phase II studies in healthy subjects and stable~     outpatients with cirrhosis.~      Part B: Multi-center (2 University Hospitals), double-blind, randomized, parallel-group~     trial. Assignment of treatment will be done according to a list (one at each study site) of~     random numbers in blocks that will be concealed until the end of the study. The control group~     will be assigned to placebo on a 1:1 ratio. The placebo and treatment will be masked.~   "
162863|NCT01434095|"~     A half-dose photodynamic therapy, a relative new treatment, has been widely performed to~     treat central serous chorioretinopathy.~      The researchers aimed to investigate whether the therapy improved the patient's visual acuity~     as well as the retinal sensitivity. The researchers also investigate which clinical factors,~     if any, were associated with the results; visual acuity or retinal sensitivity after the~     treatment.~   "
162864|NCT01434082|"~     The investigators are doing this study to look at sleep problems, daytime sleepiness, and~     thinking and behavior patterns in children with arthritis and in children without arthritis.~     Arthritis is a problem with joints. Some children have arthritis and some children do not~     have arthritis.~      Sleep disordered breathing is a sleeping problem in which some children snore and have pauses~     in their breathing during sleep. It is associated with not enough or fragmented sleep, poor~     school performance, problems paying attention, and behavior problems.~      The investigators do not know how many children with arthritis have sleep problems, and how~     it is linked to daytime sleepiness and children's learning, and behavior patterns compared to~     children without arthritis. The investigators need to study both children with arthritis and~     children without arthritis to learn more about these connections and to understand if they~     are the same or different in children with arthritis and in children without arthritis.~   "
162865|NCT01434069|"~     This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and~     FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated~     dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.~   "
162866|NCT01434056|"~     The purpose of this study is to determine whether hepatic encephalopathy, measured through~     magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds~     prognostic information to patients who are waiting for liver transplantation. If this model~     improves mortality prediction this might be used in the future for organ allocation.~   "
162867|NCT01434043|"~     This purpose of this research project is to test the diagnostic accuracy (i.e., sensitivity,~     specificity, positive and negative predictive value, and receiver operator curve area under~     the curve) of cardiac computed tomography (CT) perfusion as compared to the best non-invasive~     test of blood flow -- cardiac positron emission transmission (PET) perfusion imaging.~      The primary outcome of the study is to determine the CT perfusion technique with the highest~     overall diagnostic accuracy measured by the highest area under the receiver operator curve.~      The investigators will test 4 different CT perfusion techniques. (A) Qualitative, visual~     inspection of the contrast-enhanced CT images (B) Enhanced voxel distribution analysis (C)~     Rate of myocardial contrast enhancement analysis (D) Quantitative heart blood flow using a~     distributed 2-region analysis~      A second aim is to reduce the radiation dose needed to maintain CT perfusion diagnostic~     accuracy. Using the CT perfusion data, the investigators will model the minimal number of~     cardiac cycle radiation exposures needed to keep the diagnostic accuracy similar to the full~     data set.~      A third aim is to test the incremental diagnostic accuracy of CT angiography plus CT~     perfusion to identify regions of low blood flow as compared to PET perfusion alone.~   "
162868|NCT01434030|"~     Development of a bio-behavioral stochastic model-predictive controller (SMPC) for use as an~     artificial pancreas in T1DM requires fundamental behavioral and physiology studies, as well~     as translational modeling and engineering development. In order to be successful, closed-loop~     control in Type 1 Diabetes Mellitus (T1DM) must adapt to individual physiologic~     characteristics and to the behavioral profile of each person. An essential part of this~     adaptation is biosystem (patient) observation. The investigators propose to lay the~     foundation for a closed-loop control system which will include algorithmic observers of~     patients' behavior and metabolic state.~   "
162869|NCT01434017|"~     Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or~     without adenoidectomy may be as high as 75%.~      Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and~     serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic~     antiemetic treatments:~        -  dexamethasone alone (250 mcg/kg)~        -  dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)~        -  dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).~   "
162870|NCT01434004|"~     The purpose of this study is to determine whether a vegetable-based diet, physical activity~     program, and stress reduction training will reduce or maintain PSA levels, an indicator of~     prostate cancer progression, in men who have had their prostate gland removed following a~     prostate cancer diagnosis.~   "
162871|NCT01433991|"~     This is a multicenter, open-label, Phase 1b/2 study which will be conducted in two parts: a~     Phase 1b part comprising a dose escalation and an expansion cohort; and a Phase 2 part which~     will comprise two cohorts. The purpose of the Phase 1b part is to identify the maximum~     tolerated dose (MTD) of E7050 and E7080 (lenvatinib) in combination in subjects with~     unresectable advanced or metastatic solid tumors. In the subsequent Phase 1b expansion cohort~     and Phase 2 cohorts, additional subjects with recurrent glioblastoma or unresectable Stage~     III or Stage IV melanoma and disease progression after prior systemic treatment will be~     enrolled to confirm the MTD (expansion cohort) and to further explore the clinical activity~     of E7050 and lenvatinib.~   "
162894|NCT01433666|"~     The aim of the current project is to validate PDE4 inhibitors as a target for cognition~     enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will~     demonstrate whether memory, but also attention, information processing or executive function~     improves with the PDE4 inhibitor roflumilast in healthy humans.~   "
162874|NCT01433952|"~     Elevated levels of thiamine may increase cellular energy metabolism by increasing the~     activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial~     affect in patients with several diseases including sepsis, heart failure, and diabetes. There~     is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine.~      The aims of this study are to:~        -  Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral~          thiamine in healthy volunteers;~        -  Compare the different thiamine doses on the pharmacokinetic variables using repeated~          measures ANOVA.~   "
162875|NCT01433939|"~     The investigators wish to study the effects of position changes during colonoscope insertion~     on patient comfort. The investigators hypothesize that early position changes would reduce~     colonoscope loop formation and patient discomfort.~   "
162876|NCT01433926|"~     Main objective: To analyze the clinical and biological characteristics of patients with~     disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete~     remission, partial or stable disease for a period exceeding 3 years.~      In addition, there will be a sub-genetic analysis of patients in whom there is availability a~     sample of primary tumor preserved in paraffin. This sub-analysis will not interfere with~     routine clinical practice, as the tumor samples based on which will be held on genetic~     profile, have been preserved in paraffin was extracted from the primary tumor to the patient.~   "
162877|NCT01433913|"~     This randomized phase II trial studies how well metformin hydrochloride works compared to~     placebo in treating patients with prostate cancer undergoing surgery. Metformin hydrochloride~     may make some enzymes active. These enzymes may block other enzymes needed for cell growth~     and stop the growth of tumor cells.~   "
162878|NCT01433900|"~     A 1-year prospective, randomized, investigator-masked trial comparing the confocal and~     clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved~     prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.~   "
162879|NCT01433887|"~     The Chinese patients with chronic hepatitis C have a different genetic background, which had~     been demonstrated to significantly influence their responses to pegylated interferon and~     ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6~     infection were treated with pegylated interferon and ribavirin. Their response was compared~     amongst different genotypes.~   "
162880|NCT01433874|"~     Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter~     hospitalizations, and less post-operative pain as compared with traditional laparotomies.~     However, there is marked interindividual variability of post-operative shoulder-tip pain~     following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and~     ranges from mild to severe. In some cases, it has been reported to last more than 72 hours~     after surgery.~      The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic~     nerve irritation causes referred pain to C4. Therefore, the investigators should try to do is~     that if the investigators could reduce carbon dioxide retention in the pelvic cavity.~      This clinical controlled trial is tried to find out the practical and clinical maneuver to~     reduce post-operative should-tip pain following laparoscopic surgery.~   "
162881|NCT01433861|"~     The choice of surgical strategy for patients with proximal gastric cancer is controversial~     mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and~     anastomotic stricture. but there are no prospective randomized trials until now.~      The primary end point of this study is whether the rate of reflux esophagitis is different or~     not between LAPG and LATG. Through this study, we~   "
162882|NCT01433848|"~     The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in~     studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac~     changes were caused not only by the myotoxic effects of alcohol, but also are present in many~     patients regardless of etiology of cirrhosis.~      These changes are characterized by abnormalities of systolic contraction in patients~     undergoing physical or pharmacological stress, changes in diastolic function and~     electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy.~     Increased QT interval and the pre-ejection time changes are common in cirrhotic patients.~      To date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic~     patients, or their relationship with the prognosis of affected patients. Til now, researches~     are based on strict echocardiographic parameters, not including several modern methods of~     assessment of cardiac systole and diastole. New techniques, such as two-dimensional strain,~     can bring new diagnostic and prognostic information, and it is not reported in the~     literature. Therefore, the aim of this study is to determine the morphological and functional~     cardiac changes in patients with cirrhosis and their prognostic role by evaluating new~     echocardiographic parameters of systolic and diastolic readings.~   "
162883|NCT01433835|"~     The purpose of this study is to determine the safety and pharmacokinetics following a single~     oral dose of MBX-400.~   "
162884|NCT01433809|"~     This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies~     (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their~     utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid~     neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic~     mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H&E and~     unstained slides to specific biomarker results using immunohistochemistry.~   "
162895|NCT01433653|"~     The purpose of this study is to determine whether cognitive behavioral therapy (CG-CBT) for~     complicated grief is superior to wait list condition in patients with comorbid complicated~     grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be~     compared to changes in the wait list group.~   "
162896|NCT01433640|"~     This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D~     (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than~     95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study~     will then be used to design additional studies.~   "
162994|NCT01432353|"~     This multicenter, open-label, dose-escalating study will assess the safety and efficacy of~     DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will~     receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients~     exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up to~     17 cycles. Anticipated time on study treatment is 1 year or until disease progression or~     unacceptable toxicity occurs.~   "
162885|NCT01433796|"~     Background: Increased access to antiretroviral therapy (ART) in Africa will require~     decentralization to primary health care. For this purpose, adapted methods for management of~     patients co-infected with tuberculosis (TB) and HIV are needed. Improved detection of TB in~     patients starting ART, and assessment of co-administration of ART and TB treatment are~     priorities in this field.~      Aims: To identify clinical predictors of TB in patients starting ART, and to construct~     screening algorithms for TB in this population; to assess ART outcomes in patients receiving~     TB treatment at health centre level.~      Work plan: The project is performed in health centres providing ART in Ethiopia. A cohort of~     HIV positive patients initiating ART is prospectively followed. Baseline characteristics are~     registered; blood samples for CD4 cells, HIV RNA and immunological markers are collected, as~     well as sputum for TB culture and PCR. During ART, clinical data, CD4 cell counts and HIV RNA~     levels are followed. Patients with TB are compared to those without TB with regard to ART~     outcome. Baseline factors associated with TB will be used to construct TB screening~     algorithms.~      Recruitment of the cohort was completed in March 2013; follow-up for determination of long~     term outcome of ART will be continued until 2016.~      Significance: These studies give insight into TB-HIV co-infection at primary health care~     level in a Sub-Saharan region, and may impact future guidelines for management of such~     patients.~   "
162886|NCT01433770|"~     Alefacept, also known as Amevive®, is a medication approved by the Food and Drug~     Administration (FDA) in the United States and other countries for the treatment of psoriasis,~     which is a chronic inflammatory immunological skin condition that can result in chronic dry,~     red patches that are covered in scales. Alefacept is approved by the FDA for the treatment of~     psoriasis but not as an anti-rejection medication in transplant patients. It is now being~     tested in new kidney transplant patients as a supplement to other approved anti-rejection~     drugs. Alefacept will be used as an investigational drug in this study.~      The reason for this study is to test whether using Alefacept will inhibit T cells, known as~     memory cells, using a test named ELISPOT-IFN. In patients with psoriasis, Alefacept inhibits~     these memory cells. If memory cells specific to your donor can be inhibited by this drug, it~     might prevent rejection and promote acceptance of the transplanted kidney in a unique manner.~   "
162887|NCT01433757|"~     The purpose of this study is to evaluate if the antibiotic Ampicillin is safe and tolerated~     in patients that have generalized dystonia caused by the DYT-1 gene mutation, as compared to~     patients treated with a placebo. A placebo is a pill that looks and tastes the same as the~     real drug, but without the active ingredient. The second objective of this study is to~     determine if dystonia symptoms improve while on the study drug.~   "
162888|NCT01433744|"~     The hypotheses tested were that levels of C-Reactive Protein (CRP) would be higher in~     patients with chronic periodontitis in comparison with those without periodontal disease and~     that the non-surgical periodontal treatment would decrease levels of CRP in patients with~     chronic periodontitis.~   "
162889|NCT01433731|"~     The purpose of this study is to investigate the safety and tolerability of topical SHP141~     applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell~     Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients~     with Stage IA, IB, or IIA CTCL.~   "
162890|NCT01433718|"~     Anterior cruciate ligament (ACL) tears are disabling injuries that place a significant burden~     on the athlete. Roughly 80% of these injuries are linked to a noncontact mechanism, with more~     than 70% of them occurring while landing from a jump. Female athletes are at higher risk of~     sustaining a noncontact ACL injury due to the higher number of risk factors that they possess~     compared to their male counterparts. Due to this statistic, ACL prevention programs have been~     developed over the past 15 years in attempt to reduce this risk among the female athletic~     population. These programs have been shown to reduce the rate of noncontact ACL injuries in~     females by correcting the risk factors associated with them. However, it remains unclear as~     to whether these positive results are solely due to the program or a higher exercise workload~     in its participants. The purpose of this study is to evaluate the effectiveness that an ACL~     prevention program has on modifying at-risk landing mechanics (associated with noncontact ACL~     injury) compared to a resistance training program of equal workload.~   "
162891|NCT01433705|"~     Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers)~     in the heart using PET imaging. These tracers would be eventually used in evaluating the~     hearts of patients with heart disease.~      Normal healthy volunteers will be carefully screened for this study. Subjects will be given~     IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects not~     excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will~     undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the~     hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin~     according to standard procedures in our laboratory.~      These same subjects will have a F-18 FDG protocol after following a high fat, protein~     permitted, no carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The~     F-18 FDG radiotracer will be given through an IV.~   "
162892|NCT01433692|"~     Background: Cannabis is the most prevalent illegal drug used in France, and consequences~     arising from the step of 'casual consumers'(1-10 joints/month). Side effects of cannabis are~     now well documented: Trauma (driving after consuming cannabis), respiratory, cardiovascular~     diseases and psychiatric and social problems. The general practitioner (GP) is the health~     professional most viewed by adolescents. Brief interventions (BI) for adult alcohol use have~     been shown to be efﬁcient. Some BI have been designed to inspect adolescents and consumption~     of cannabis have been piloted, showing their feasibility, but no test has validated them.~      Aim : Does a BI conducted by general practitioners reduce consumption of canabis in 15 to 19~     years old ?~      Method:~      Two preliminary qualitative studies (with adolescents and GP), were used to analyze the~     difficulties of communication around cannabis use. The Scientific Committee has analyzed the~     results and developed a workshop around BI, adapted to adolescents cannabis users.~      CANABIC is a quantitative study to validate use of BI with cannabis users: a randomized~     controlled trial, clustered study, comparing an intervention group (IG) and a control group~     (CG). The intervention is the achievement of the IB during a specific consultation. The~     outcome is the consumption of cannabic (Number of joints / month).~      The study will be carried out in 3 french regions : Auvergne, Rhône-Alpes and~     Languedoc-Roussillon. 150 GPs wil be recruited and randomized in intervention group or~     control group (ratio 1 :1).~      Each GP will inlcude 5 adolescents (i.e. a total of 750 adolescents) - . The number of~     adolescents needed has been calculate with hypothesis of a significant difference of 30% in~     consumption of cannabis between adolescents who beneficied of BI (IG) and those who do not~     experienced BI ( CG) A pilot study has been conducted. Cannabis use by adolescents has~     decreased. Their perception of cannabis has changed: they are aware of the harmful effects of~     their consumption. This pilot study has improve many points of the protocol.~      Results:~      A decrease of 30% of consumption is expected (joints per month). Perception of cannabis by~     adolescents will be reviewed.~      Conclusions:~      To validate an IB adaptated to consultation with adolscents cannabis consumer in order to~     provide a tool for GP in their daily practice.~   "
162897|NCT01433627|"~     This protocol describes a study to compare intended trans-radial versus trans-femoral~     intervention and bivalirudin monotherapy versus current European standard of care consisting~     of unfractionated heparin (UFH) plus provisional use of glycoprotein IIb/IIIa inhibition via~     the use of one of the three available agents on the market (e.g. abciximab, tirofiban or~     eptifibatide) in patients (≥18 years) with ACS, that are intended for an invasive management~     strategy. This study will be conducted in compliance with Good Clinical Practices (GCP)~     including the Declaration of Helsinki and all applicable regulatory requirements.~   "
162898|NCT01433614|"~     Anthracycline-taxane regimens are effective means of postponing progression in metastatic~     breast cancer. It is yet unclear whether addition of capecitabine to this combination~     improves the treatment outcome.~      Patients with advanced breast cancer are randomized to first-line chemotherapy with a~     combination of epirubicin (Farmorubicin®) and paclitaxel (Taxol®) alone (ET) or in~     combination with capecitabine (Xeloda®, TEX). Starting doses for ET are epirubicin 75 mg/m2~     plus paclitaxel 175 mg/m2, and for TEX epirubicin 75mg/m2, paclitaxel 155 mg/m2, and~     capecitabine 825 mg/m2 BID for 14 days. Subsequently, doses are tailored related to side~     effects.~      Primary endpoint is progression-free survival (PFS); secondary endpoints are overall survival~     (OS), time to treatment failure (TTF), objective response (OR), safety and quality of life~     (QoL).~   "
162899|NCT01433601|"~     This project aims to assess different antiretroviral treatment strategies, optimally~     controlled and conventional, in relation to drug resistance and virological treatment~     failure. A Randomised Controlled trial (RCT) where Vietnamese HIV+ patients with CD4+ T-cells~     <200/ul are randomized into either enhanced treatment support (ETS) through peer supporters~     or The National AIDS Control Program recommended self supervised treatment (SST). The~     treatment strategies will be assessed and compared in relation to treatment adherence and~     drug resistance development with virological treatment failure as primary endpoint. The~     results from this project will lead to an increased knowledge in relation the impact of~     treatment support on adherence, virological suppression and resistance development and have~     an impact on HIV treatment policies in low income settings globally.~   "
162900|NCT01433588|"~     The purpose of this study is to see if the Calmer is more effective at managing acute pain in~     preterm infants in the neonatal intensive care than the current standard of care in the unit.~      Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain~     scores and lower heart rates, and more stable autonomic regulation as measured by heart rate~     variability indices, than infants given a soother plus facilitated tucking (standard of care)~     during routine blood collection.~   "
162901|NCT01433575|"~     This single-center, open-label, single dose, randomized, two-way cross-over study will~     evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese~     volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20~     mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be~     re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.~   "
162902|NCT01433562|"~     This is a 2-arm, randomized, double-blind, placebo-controlled study aiming to determine the~     efficacy and safety of DLBS1425 in combination with anthracyclin-based regimen as a~     neoadjuvant therapy in subjects with previously untreated stage II or III (operable) breast~     cancer.~      The anthracyclin-based regimen in the study will be either CAF/iv and CEF/iv only. The~     neoadjuvant anthracyclin-based chemotherapy will be given for 3 cycles. The length of each~     cycle will be 21-28 days.~   "
162903|NCT01433549|"~     The purpose of this study was to assess the impact of lens-free (recovery) intervals of~     varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.~   "
162904|NCT01433536|"~     Bone fractures in traumatic brain-injured and spinal cord-injured patients often heal faster~     than in other patients. However, such patients are also occasionally prone to bone formation~     in soft tissues such as muscle. This process is called heterotopic ossification and tends to~     occur around joints. Patients with heterotopic ossification often suffer from complications~     such nerve compression, ankylosis, chronic pain, osteoporosis, and infections. Loss of~     movement can also interfere with function and the quality of life of patients already~     experiencing difficulties associated with their trauma. Positioning, transfers, and hygiene~     become difficult and even impossible, which worsens the loss of autonomy.~      Previous research has suggested that an osteoinductive factor (which has the capacity to~     induce the formation of bone) may be released into the bloodstream following a head or spinal~     cord injury. The investigators laboratory has shown that a growth factor called BMP-9, when~     injected into a damaged mouse muscle, has the ability to cause strong ossification in damaged~     muscle. The investigators would like to find out whether the levels of BMP-9 and/or its~     receptor (which is called ALK1) increase after traumatic brain and spinal cord injuries that~     occur at the same time as serious orthopaedic traumas.~      The main goal of the investigators study is thus to determine whether BMP-9 levels increase~     in the serum of trauma patients.~   "
162905|NCT01433523|"~     The purpose of this trial is to investigate if treatment with house dust mite allergen~     immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust~     mite induced asthma.~   "
162906|NCT01433510|"~     The purpose of this study is to assess the safety profile of specific immunotherapy with~     Grazax for three consecutive grass pollen seasons.~   "
162907|NCT01433497|"~     The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day~     versus placebo in the treatment of patients with primary progressive multiple sclerosis or~     relapse-free secondary progressive multiple sclerosis.~   "
162923|NCT01433289|"~     The purpose of this study is to determine the safety, toxicity, dosing, and antiviral effects~     of epigallocatechin gallate (EGCG) in capsule form (Polyphenon® E), administered orally twice~     daily at three different doses in HIV-1-infected clinically stable, treatment-naïve and~     treatment-experienced adults not on concomitant antiretroviral (ARV) therapy.~   "
163038|NCT01431781|"~     Pancreatitis are one of the most common complications of post-ERCP (Endoscopic Retrograde~     Cholangiopancreatography), the incidence rate is 5&-10%, how to prevent PEP and~     hyperamylasemia is an important issue, somatostatin is widely used in the field of pancreas~     treatment. In order to explore the effects of somatostatin on prevent PEP(post-ERCP~     Pancreatitis), 908 subjects will be enrolled in two group in the study, one group is given~     common treatment, the other uses somatostatin in the base of common treatment.~   "
162908|NCT01433484|"~     This study aims to reduce cardiovascular disease (CVD) risk and disparities in risk by~     improving lifestyle factors which underlie the development of CVD. The first steps will~     involve conducting a comprehensive formative evaluation to assess individual, interpersonal,~     organizational, community, and policy factors relevant to CVD risk and risk reduction in~     Lenoir County. This will be followed by a community-based lifestyle intervention program~     designed to improve eating patterns, promote physical activity, and for those who are~     interested, support weight loss. A randomized trial comparing the effectiveness of two~     community based weight maintenance interventions will also be conducted. Community-wide~     policy and environmental change interventions will also be implemented to support the~     individual-level interventions, including partnerships with businesses to promote a healthy~     environment through innovative economic opportunities. In addition, this project will explore~     genetic factors associated with cardiovascular disease risk and treatment success.~   "
162909|NCT01433471|"~     The purpose of this study is to understand the immune response activated in the human~     gastrointestinal tract by Trichuris Suis Ova (TSO) in patients with ulcerative colitis.~   "
162910|NCT01433458|"~     This study will assess the pharmacokinetics of RLX030 during and after administration in~     subjects with mild to severe hepatic impairment and matched healthy control subjects.~      20 to 24 patients and 20 to 24 healthy subjects will be enrolled.~   "
162911|NCT01433445|"~     This study will assess safety as well as establish a Recommended Phase II dose of the~     combination of panobinostat and ruxolitinib in patients with or without the JAK2V617F~     mutation who have been diagnosed with primary myelofibrosis (PMF), Post Essential~     Thrombocythemia Myelofibrosis (PET MF), or Post-Polycythemia Vera Myelofibrosis (PPV MF).~   "
162912|NCT01433432|"~     The open label extension study (Protocol C2/13/DR-6MP-02 EXT) is designed to evaluate the~     clinical efficacy and safety of 80 mg DR-6MP test formulation for an additional 12 weeks in~     subjects who already completed 12 weeks of Protocol C2/13/DR-6MP-02. Crohn's disease (CD)~     therapy is aimed at reducing inflammation via induction of remission after a flare-up and~     maintenance of the remission for as long as possible. The questions being asked in this~     extension study are:~        1. For subjects who received 80 mg DR-6MP for 12 weeks: Can the clinical efficacy and~          safety status achieved following 12 weeks of treatment be maintained or improved~          following an additional 12 weeks of DR-6MP treatment?~        2. For subjects who received oral Purinethol (1-1.5 mg/kg daily) for 12 weeks: Can the~          clinical efficacy and safety at 12 weeks be maintained or improved following the~          introduction of 12 weeks of 80 mg DR-6MP treatment?~   "
162913|NCT01433419|"~     The purpose of this study is to evaluate the safety and efficacy of treatment with TAK-875 in~     diabetic patients.~   "
162914|NCT01433406|"~     The purpose of this study is to evaluate the safety and efficacy of long-term treatment with~     TAK-875 in diabetic patients.~   "
162915|NCT01433393|"~     The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in~     diabetic patients.~   "
162916|NCT01433380|"~     The primary purpose of this study is to evaluate the pharmacodynamics of single oral doses of~     PF-05175157 in healthy volunteers~   "
162917|NCT01433367|"~     This study will be a non-randomized trial consisting of patients with single level (C3 to C7)~     symptomatic cervical disc disease who have not previously received fusion surgery at the same~     level, and have failed to improve with conservative treatment for at least 6 weeks prior to~     enrollment, or who present with progressive neurological symptoms or signs in the face of~     conservative treatment.~   "
162918|NCT01433354|"~     The purpose of this study is to generate long-term safety, tolerability and efficacy data for~     AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214~     study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients~     below 18 years of age provided the patient is at least 12 years of age at the time of entry~     into the current study.~   "
162919|NCT01433341|"~     Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of~     electronic signals emitted by four footplates, one for each heel and toe, respectively. These~     are sensitive to vertical pressure produced by a subject standing straight but in various~     positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields~     additional parameters not obtained by the traditional monoplate stabilometers, namely,~     weight-distribution patterns and correlation among six combinations of paired outputs from~     the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric~     synchronizations).~      Most athletic injuries occur at the end of an activity, when the participant is fatigue. It~     is likely that significant portion of the injuries result from instability of the lower~     extremity joints as a consequence of fatigue of the stabilizing muscles. Muscle fatigue~     increase postural sway, impaired muscle control, and increase the onset delay of movement.~     Comparing pre-exercise with post-exercise results for each athlete, should detect significant~     and clinically meaningful differences with the Tetra-ataxiametric measures of stability,~     interaction between Fourier Spectral Power Ranges of body sway, weight distributions, and~     synchronizations of toe parts. The method is suitable for young subjects, and the equipment~     is portable and tests can be conveniently carried out in a child's familiar training setting~     and right before/after exercise.~      The goal of the present study is to measure the balance of the athletes after different types~     of exercises, to measure the ability of the athletes to recover different types of exercises,~     and to measure the influence of increasing physical fitness on balance ability. Fifty~     basketball and football players between the ages of 12 and 18 years old will be examined~     following informed consent from the children and their legal guardian. Each participant would~     be measured three times during the year (pre-season, middle-season, and post-season), three~     times each (before-training, after aerobic warming-up, and after-training) on the Tetrax.~     Additionally, physical parameters (as height, and weight), anatomical parameters (as leg~     length), and joint range of movement, would be record.~   "
162920|NCT01433328|"~     Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating~     pulmonary arterial hypertension but infusion site pain may be very severe in some patients.~     The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion~     of lidocaine (a local anesthestic) to treat the pain.~   "
162921|NCT01433315|"~     Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The~     investigators wish to determine whether 9 nights of modest sleep restriction results in~     activation of cardiovascular disease mechanisms, thus potentially increasing the risk of~     cardiovascular disease. The investigators hypothesize that sleep restriction will result in~     elevated blood pressure, inflammation, and neurocognitive deficits.~   "
162922|NCT01433302|"~     The goal of this clinical research study is to measure the amount of inflammatory proteins~     inside the body before and after lymphatico-venular bypass surgery. This will help doctors~     learn if anti-fibrotic or anti-inflammatory drugs/treatments given with the surgery can~     improve how well the surgery works.~   "
162924|NCT01433276|"~     Indication: Resuscitation in pts with hemorrhagic shock due to multiple injuries~      Prospective, open label RCT in pts. with traumatic hemorrhagic shock in RS Hasan Sadikin~     Hospital, Indonesia.~      PI: Dr. Kiki Lukman, PsBD(K), Surgery, RSHS. Co-PI: (late)Prof. Xavier Leverve MD, PhD,~     Directeur, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université Joseph Fourier,~     France~      Hemorrhagic shock is a cause of death in trauma.Fluid resuscitation to ensure stable~     hemodynamics and microcirculation by rapidly restoring circulating plasma volume could be a~     cornerstone of managing trauma patients. Excessive fluid accumulation particularly in the~     interstitial tissue should be avoided. Hypertonic solution shows promise in restoring~     intravascular volume expansion and microcirculation with less fluid infusion in hypovolemic~     patients. This study investigated efficacy and safety of hyperosmolar Na lactate(Totilac®)~     for resuscitating traumatic hemorrhagic shock patients.~      Patients with multiple injuries with grade III hemorrhagic shock and RTS ≥4 received std~     initial fluid resuscitation of upto 2 liters of isotonic crystalloid. They also got similar~     dose of either hyperosmolar Na lactate or ringer's lactate. Hemodynamic status, fluid balance~     and and safety was recorded during the study.~   "
162925|NCT01433263|"~     A safety & efficacy clinical study of the investigational medicinal product BYM338 for the~     treatment of unintentional weight loss in patients with cancer of the lung or the pancreas~   "
162926|NCT01433250|"~     The study will assess the long-term safety and tolerability of AIN457 in patients with~     relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of~     maintenance of efficacy and health related quality of life will be explored.~   "
162927|NCT01433237|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with~     rhabdomyosarcoma.~   "
162928|NCT01433224|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies samples from younger patients with malignant germ cell~     tumor progression.~   "
162929|NCT01433211|"~     The purpose of this study is to investigate the association between nutrition and frailty in~     older community-living persons.~   "
162930|NCT01433198|"~     Aim:~      - to investigate the effects of an aquatic exercise program in patients with severe scars~      Patient population:~        -  10 patients of at least 18 years old~        -  patients with scars after burns or other severe skin injuries~        -  stratification into two groups: an intervention group and a control group~      Method:~        -  8 patients will participate in the aquatic exercise group and 2 patients in the control~          group~        -  assessment of physical fitness parameters, scar tissue and psychosocial impact~      Hypothesis:~      - patients of the aquatic exercise group will recover sooner and better (physically and~     psychologically) than patients of the control group~   "
162931|NCT01433185|"~     Early accurate diagnosis is one of the first crucial steps in care for infants born to~     HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early~     diagnosis and results in significant reductions in infant morbidity and mortality. There is~     little information on evidence-based interventions that specifically target improved~     attendance of postpartum clinic visits and subsequent infant HIV testing in the context of~     prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose~     a randomized controlled trial to examine the effect of text messages sent to women enrolled~     in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant~     diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses~     that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the~     postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to~     women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks~     among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence~     to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior~     to standard care, the proposed intervention can be easily scaled-up and integrated into~     existing healthcare systems in resource-limited settings. Findings from this study will~     provide randomized trial evidence to inform HIV prevention program planners and implementers.~     This study will also provide further information on the feasibility of using mobile~     phone-based technology for public health interventions in resource-limited settings.~   "
162932|NCT01433172|"~     The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in~     combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to~     find out if the vaccine and the drugs can boost the immune system of these patients and how~     their immune system reacts, both before and after the vaccine treatment.~   "
162933|NCT01433159|"~     The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care~     in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury,~     measured as change from baseline in composite wound bed scores of the PUSH 3.0 tool.~   "
162934|NCT01433146|"~     Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity~     and influence Survival in Colorectal Cancer Patients~   "
162935|NCT01433133|"~     This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study.~     The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.~      All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex~     vivo transduced with genetic construct containing the gene for interferon)tissue implants~     intended to provide sustained production and delivery of therapeutic levels of INF for up to~     twenty four (24) weeks following INFRADURE Biopump implantation. Follow up will continue for~     a total of two years post INFRADURE Biopump implantation~   "
162989|NCT01432418|"~     This is a 3-year multi-centre, single-blinded, randomized controlled trial (RCT) to test the~     hypothesis that wheelchair skills training (using a systematic training program called the~     Wheelchair Skills Training Program) improves wheelchair skills and safety of 144 powered~     wheelchair users. A second objective is to assess the effects of age, sex, training centre,~     and participant experience on outcomes, assessing the retention of benefits and assessing the~     impact of training on other important outcomes.~   "
162936|NCT01433120|"~     Studies of the human gut microbiome have suggested that treatment or prevention aimed at the~     obese microbiome could influence the development of obesity-associated metabolic~     disturbances.~      The objective of this project is to explore if a dietary intervention in 60 obese women with~     the probiotic Lactobacillus paracasei ssp paracasei F19 or flax seed fibres targeting the gut~     microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and to~     explore the interaction between the human genome and the gut microbiome.~      The study is based on the following hypotheses:~        -  Treatment with the probiotic Lactobacillus paracasei ssp paracasei F19 and flax seed~          fibres will lower the metabolic risk profile in the intervention groups compared with~          placebo.~        -  The effect on the metabolic risk markers can be correlated with changes in the gut~          microbiota (measured in faeces).~      After completion of the dietary intervention, the participants are offered a 10-week weight~     reduction program. Those who participate in the weight-loss program are invited to an~     optional follow-up visit in connection with the last visit at the clinical dietician, for the~     purpose of exploring the effect of weight loss on the gut microbiota and obesity-associated~     metabolic disturbances.~   "
162937|NCT01433107|"~     This study will compare the efficacy and safety of a single dose of terbinafine film forming~     solution 1% with a single dose of placebo film forming solution in the treatment of tinea~     pedis.~   "
162938|NCT01433094|"~     Background: Psychosis in the spectrum of schizophrenia (PSS) are severe mental disorders,~     with a high impact on disability and participation. Poor adherence to pharmacotherapy~     negatively impacts on the course and outcome of PSS.~      Non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of~     relapse and readmission up to 5-time higher than in adherent patients. Falloon et al.~     developed a Psychoeducation Program (FPP) aimed at improving communication and~     problem-solving abilities in patients and their families. Past studies reported a~     statistically significant reduction of the risk of relapse in patients receiving the FPP, but~     did not take into account effects on adherence.~      Objectives: To evaluate changes in adherence to pharmacotherapy in a sample of patients~     diagnosed with PSS (ICD-10: F20 to F29), by comparing a group exposed to the FPP with another~     group exposed to a treatment with generic informative prospects on the disorders provided~     with same attendance frequency as the FPP (Generic Treatment - GT).~      Methods: 340 patients with PSS, from 10 participating units distributed in the territory of~     the Italian National Health System, will be enrolled, with allocation 1:1. The sample will be~     randomized into an exposed group (to FPP) and an unexposed group. Adherence will be assessed~     on a three-monthly basis with blood levels of the primary prescribed drug by High Pressure~     Liquid Chromatography, with a self-report, the Medication Adherence Questionnaire, and~     concurrently with the administration of a 4-item interview, based on a modified version of~     the Adherence Interview. Survival analyses will be performed using Kaplan-Meier method,~     followed by Log-rank test, defining as terminal events both the start of non-adherence and/or~     the first relapse or readmission episode. Intention-to-treat will be applied in considering~     the primary and secondary outcomes. Multiple imputations will be applied to integrate missing~     data.~      Expected results: Median prevalence of non-adherence to pharmacotherapy in patients already~     in contact with a psychiatric service is 47%; effect size of psychosocial treatment on~     various outcomes, including relapse, readmission and adherence to drug is 0.48 of the~     standard deviation (SD), with 95% C.I.=0.10 to 0.85. The intervention is expected to produce~     a change in the prevalence of non-adherence to drug in the exposed group with an effect size~     of 0.45 SD.~   "
162939|NCT01433081|"~     A national survey has revealed that 80% of patients experienced pain after surgery and 86% of~     these patients had moderate, severe or extreme pain (1).Postoperative pain can extend~     recovery room stay after surgery and it is also a common cause of unanticipated admissions~     which have important economic implications(2).More importantly, postoperative pain can lead~     to a poor quality of recovery in ambulatory patients. The Intraoperative use of medications~     that might decrease postoperative pain is therefore highly desirable.~      Some medications such as lidocaine and ketamine have been proved to decrease postoperative~     pain when given during the Intraoperative period in ambulatory patients(3,4) but it is still~     unknown if those medications can in fact lead to a better quality of recovery .~      Magnesium sulfate is a non-competitive calcium antagonist at the N-methyl-D- aspartate (NMDA)~     receptor(5). NMDA receptors have an important role on pain modulation (6). The use of~     Intraoperative magnesium in order to decrease postoperative pain had contradictory results in~     different studies. Some studies have shown a potential benefit of magnesium in decreasing~     postoperative pain (7,8) while others have not demonstrated any benefit (9,10).~      In the ambulatory setting, specifically, Tramer et al. did not find any improvement on~     postoperative pain after an Intraoperative dose of magnesium for patients undergoing~     ilioinguinal hernia repair(11). Koinig et al., however, demonstrated a significant reduction~     in the postoperative analgesic requirements in patients undergoing arthroscopic knee surgery~     (12).~      Even though, the reduction of postoperative opioid requirement has been used in many studies~     in the ambulatory literature, it has been recently questioned by some investigators~     (13).Patients might take more opioid medications but they may not necessarily develop opioid~     related side effects such as nausea and vomiting. A more global evaluation of the patient~     involving several aspects of recovery would be more significant.~      The modified quality of recovery 40(MQOR40) is a validated 40 item instrument to assess the~     quality of postoperative recovery (14). Myles et al. concluded that the MQOR40 would be a~     useful outcome measure to assess the impact on changes in health care delivery (15), but~     anesthesia studies underutilize this instrument.~      As more complex and painful procedures are being done in the ambulatory setting , the use of~     non-opioid strategies to control postoperative pain and to enhance quality of recovery will~     have even a greater role in the anesthetic management of patients. Magnesium has not been~     established as a potential adjuvant in ambulatory patients with conflicting results of~     previous investigators. The main objective of this study is to evaluate if the Intraoperative~     use of magnesium have the ability to improve postoperative quality of recovery in ambulatory~     patients.~   "
162940|NCT01433068|"~     RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size~     of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and~     radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering~     surgery more feasible or easier and achieve better local control of the tumor.~      PURPOSE: This Phase I trial aims at evaluating the feasibility of the NBTXR3 injection in the~     tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.~   "
162941|NCT01433055|"~     Schizophrenia is a devastating and costly illness. One-third to one-half of people with~     schizophrenia do not respond to the most current drugs leaving clozapine as the best~     alternative for treatment. However, over 60% of people treated with clozapine continue to~     have persistent symptoms and cognitive impairments. Little data is available to support~     evidence-based recommendations to guide clinicians in treating these patients. Preliminary~     data has suggested that adjunct treatment with minocycline may offer robust symptom~     improvement in patients with schizophrenia, including those taking clozapine. Minocycline has~     had interesting effects; including suggesting it may have a significant role in treatment of~     neurologic and psychiatric disorders. Minocycline is currently available generically; its~     side effects are well-described and minimal. The proposed double-blind treatment study seeks~     to demonstrate that adjunctive minocycline offers patients superior efficacy for persistent~     positive symptoms, cognitive impairments, and/or other components of schizophrenia pathology.~     This knowledge could lead to the more effective treatment of patients with schizophrenia. The~     research itself may lead to a better understanding of the pathophysiology of positive~     symptoms and cognitive impairments, which could contribute to improved treatments in the~     future.~   "
162990|NCT01432405|"~     The purpose of this study is to examine the effect of exenatide, an anti-diabetes medication,~     on liver fat and blood levels of proteins that influence liver fat.~   "
162991|NCT01432392|"~     The purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD)~     treatment in primary care setting on symptom control and daily life in symptomatic GERD~     patients, using both GERD questionnaire and clinical symptoms assessment~   "
162942|NCT01433042|"~     Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality,~     and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps,~     which will create more images for evaluation, and therefore should improve diagnostic~     accuracy.~      Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small~     bowel disease.~      Preparation for procedure will include 12 hours fasting prior to the capsule ingestion~      Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear~     liquids 2 hours post ingestion, and eat 4 hours post ingestion.~      Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of~     capsule performance will be captured~   "
162943|NCT01433029|"~     The goal of this research study is to develop a method of rating videos of CAB procedures~     that will produce a reliable assessment of a cardiothoracic surgical trainee's technical~     proficiency. In addition, researchers also want to learn if using a video manual to train~     raters can help improve rater reliability.~   "
162944|NCT01433016|"~     The Exalenz clinical investigation is a multicenter, non-randomized, study of the~     ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to~     evaluate the capability of the OBT measurement to differentiate between presence and absence~     of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.~   "
162945|NCT01433003|"~     Thrombotic thrombocytopenia purpura / hemolytic uremic syndrome (TTP/HUS) is a rare,~     life-threatening disorder. TTP/HUS causes multiple blood clots to form, which prevents blood~     from reaching the brain and kidneys. TTP/HUS affects 3-5 people per million per year. Anyone~     can develop TTP/HUS, but it is most common among 30-40 year olds, and women are twice as~     likely as men to acquire the condition. TTP/HUS sometimes develops as a result of medication~     use, pregnancy or cancer; however, for the majority of patients (80%) the cause of TTP/HUS is~     unknown. In 1991, researchers discovered that plasma exchange was superior to plasma infusion~     in treating idiopathic TTP/HUS. During plasma exchange the patient's blood plasma is removed~     and replaced with healthy blood plasma. Without plasma exchange, the survival rate for~     TTP/HUS is extremely low, with fewer than 5% of patients surviving. Treating TTP/HUS with~     plasma exchange improved the survival rate to 80%. Although this represents a dramatic~     improvement, researchers are still searching for methods to improve survival. No major~     advances in treating TTP/HUS have occurred in the past 20 years. Recent research suggests~     that high-dose plasma exchange may improve the survival of TTP/HUS patients. The~     investigators will conduct a randomized controlled trial to test whether treating TTP/HUS~     patients with high-dose versus standard-dose plasma exchange improves the treatment response.~     The investigators will recruit 150 patients with TTP/HUS from 9 centres across Canada over~     three years. The investigators will evaluate whether high-dose plasma exchange improves the~     treatment response, survival, and whether it reduces the number and volume of plasma exchange~     procedures and duration of hospital stay.~   "
162946|NCT01432990|"~     Until now, there's still no any strong evidence supported which is the best way to~     restoration walking ability in spinal cord injury. Most of the evidence suggest that, there~     is somehow better after gait rehabilitation for ASIA classification C and D but not improved~     walking ability for ASIA classification A and B. There is an RCT showed the evidence of~     repetitive locomotor training and physiotherapy could be improved walking and basic~     activities of daily living after stroke, these might be also really effect in SCI patients.~   "
162947|NCT01432977|"~     The aim of this study is to demonstrate that the association paracetamol / ondansetron is not~     as effective as the association paracetamol / droperidol in the treatment of pain in children~     following tonsillectomy. The secondary objectives are to compare opioid consumption (morphine~     / codeine) and the cumulated incidence of nausea and vomiting between the two groups of~     patients in the first 24 hours after~   "
162948|NCT01432964|"~     In craniofacial trauma, the involvement of orbital structures is noted in up to 40% of cases~     (Ellis 1985). Post-traumatic orbital deformities caused by incorrect reconstruction of~     orbital dimensions are severe complications causing enophthalmos, diplopia and visual acuity~     disturbance. To prevent such complications, immediate repair of orbital injuries with the~     restoration of normal anatomy is indicated in orbital floor fractures. With the help of~     biodegradable implants small and medium-sized defects are easily managed (Büchel 2005, Lieger~     2010). In extensive fractures however, only calvarian bone and titanium mesh considered to~     provide a sufficient support of the orbital content.~      Calvarial bone can be difficult to mould and to adapt to the form and size of the orbital~     lesion. In addition, donor site morbidity cannot be disregarded. Orbital reconstruction mesh~     on the other hand is always available and easier to apply. There are however important~     requirements for these meshes, such as biocompatibility, excellent stability, optimal~     adaptability and patient comfort. Recently, the company Medartis developed a titanium mesh~     featuring a low profile. In order to regain normal function, normal anatomy has to be~     re-established. It therefore seemed reasonable to assess an implant, which would facilitate~     orbital reconstruction without disturbing normal anatomy by its size, profile height or~     properties.~      The purpose of this study was to assess the use and accuracy of the low profile titanium mesh~     for primary internal orbital reconstruction.~   "
162949|NCT01432951|"~     The purpose of this study is to assess the pharmacokinetics of enzastaurin and its~     metabolites in native Chinese patients with advanced and/or metastatic solid tumors or~     lymphoma. Information about any side effects that may occur will also be collected. Treatment~     of disease is not the main purpose of the study.~      This is a Phase 1 study of enzastaurin in native Chinese patients with advanced and/or~     metastatic solid tumors or lymphoma. Patients will receive daily doses of enzastaurin for 14~     days, stop dosing for 3 days during PK sampling, and resume dosing on Day 18. Patients may be~     allowed to receive enzastaurin for approximately 2 to 4 weeks after day 18 to provide an~     opportunity for a patient's oncologist to assess the potential benefit of the patient~     continuing to receive enzastaurin in the safety extension phase. There is no planned duration~     for the extension phase; patients are allowed to continue receiving enzastaurin until disease~     progression or other reason for discontinuation as per the investigator's assessment.~   "
162992|NCT01432379|"~     This is a post authorization observational study to monitor the utilization practices and~     describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of~     headaches in adult patients with chronic migraine.~   "
162950|NCT01432938|"~     Warfarin is a commonly used drug to prevent the blood from clotting. The purpose of this~     study is to determine if dulaglutide (LY2189265) affects how warfarin works. The study~     involves two different treatments (Treatment 1: warfarin; Treatment 2: dulaglutide +~     warfarin) separated by a minimum washout period of 24 days. In Treatment 1, the participant~     will receive 10 milligrams (mg) of warfarin on Day 1. In Treatment 2, the participant will~     receive a 1.5-mg dose of dulaglutide (LY2189265) as an injection on Day 1 and then a 10 mg~     dose of warfarin on Day 3. Participants will be randomly assigned into different treatment~     sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2.~     Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.~   "
162951|NCT01432925|"~     SUMMARY~      Rationale: Buruli ulcer, caused by Mycobacterium ulcerans, is an ulcerative disease endemic~     in West Africa. It often leads to functional limitations. Treatment was by extensive surgery,~     until in 2005 gradually antibiotic treatment for eight weeks with rifampicin and streptomycin~     was added. Observation of Buruli ulcer lesions of limited size during antibiotic treatment~     showed that during treatment there is a paradoxical increase of the lesion, with a decrease~     of the lesion after week 14. Current WHO protocols advise to decide whether surgery is needed~     four weeks after the start of antibiotics. This might be too early in the healing process.~     The investigators hypothesize that delay in surgery is safe, and that it results in a~     reduction of the number of surgical interventions.~      Objectives:~      Primary Objective of this study is to compare the need for surgical treatment in standard~     timing of surgery at the end of eight weeks antimicrobial treatment with a policy to postpone~     surgical treatment until week 14.~      Secondary Objectives are to study whether postponing surgery leads to less extensive surgery~     and a change in frequency of functional limitations;~      Study design:~      Patients will be randomized for surgery at week 8 after start of antibiotic treatment and~     week 14 after start of treatment. Reasons for treating doctors to decide to intervene with~     surgery will be according to current clinical practice and will be clearly defined in this~     protocol. Standard care of eight weeks of rifampicin and streptomycin will be given. All~     patients will be followed and lesional size using acetate sheet recordings will be used~     during follow-up.~      Study population: Patients with a clinical picture of Buruli ulcer disease confirmed by~     diagnostic tests in the districts covered by the Buruli ulcer centers in Lalo and Allada,~     Benin. Patients who are pregnant, have a contraindication for general anaesthesia and~     children below three years old will be excluded. 130 Patients in each treatment arm will be~     included to detect a difference in percentage of patients needing surgery of 20 percent.~      Main study parameters/endpoints: Primary outcome measure is the number of patients healed~     without surgery. Secondary outcome measures are the extent of surgery by measurement of~     lesional size, functional limitations after the end of treatment and one year after the start~     of treatment and the duration of admission.~   "
162952|NCT01432912|"~     The purpose of the study is to see if a short seminar educating physicians about smoking~     cessation counselling will effectively improve their smoking counselling cessation practices.~   "
162953|NCT01432899|"~     Background:~      - Childhood-onset dystonia is caused by a brain injury. It causes muscle contractions and~     twisting movements that the person with dystonia cannot control. The term hemidystonia is~     used when only one side of the body is affected. When dystonia starts during childhood, the~     brain and nerves may not develop normally. People with hemidystonia can become disabled~     because of the unwanted postures and twisting that dystonia causes. More research is needed~     to determine how dystonia affects brain development.~      Objectives:~      - To study brain function in people with hemidystonia.~      Eligibility:~        -  Individuals between 18 and 40 years of age who developed hemidystonia before age 13.~          Only one wrist may be affected by hemidystonia, and participants must have at least some~          movement in that wrist.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  This study requires five visits to the NIH Clinical Center: a screening visit and four~          study visits. Each visit will last up to 3 hours. Visits will be scheduled about once a~          week. The study procedures may be done in any order.~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have the following tests:~        -  Brain magnetic resonance imaging scan. During the scan, participants will be asked to~          move their hand at the wrist when they hear a tone.~        -  Motor tests of arm movement, balance, and walking. These tests may also examine nerve~          development and muscle tone.~        -  Two transcranial magnetic stimulation sessions to study the electrical activity of the~          muscles and brain. These sessions may also involve sensory tests. Participants will have~          hearing tests before the first session and after the second session.~        -  No treatment for hemidystonia will be provided as part of this study.~   "
162954|NCT01432886|"~     The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the~     tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and~     estimate the recommended dose.~   "
162955|NCT01432873|"~     Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of~     mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc~     sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis~     and positive effects are seen. Our purpose in this double blinded randomized study is to~     evaluate the selenium effect on mucositis prevention in patient with acute myeloid leukemia~     (AML) & acute lymphoblastic leukemia (ALL) whose received Busulfan and/or Cyclophosphamide~     before Hematopoietic stem cell transplantation (HSCT).~   "
162956|NCT01432860|"~     The almost 724,000 Americans survivors of melanoma are estimated to have 4 first degree~     relatives per case; thus, 2.8 million Americans are at increased risk of developing melanoma~     in comparison to the general public. Skin self-examination (SSE) with the assistance of a~     partner by these individuals could improve survival. If effective, the workbook tested in~     this proposal could be distributed to people at risk of developing melanoma by large scale~     means in physicians office.~   "
162957|NCT01432847|"~     Background:~      - Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and~     Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the~     back of the eye. Doctors cannot safely obtain retinal cells to study these diseases. However,~     cells collected from hair follicles, skin, and blood can be used for research. Researchers~     want to collect cells from people with Best disease, L-ORD, and AMD, and compare their cells~     with those of healthy volunteers.~      Objectives:~      - To collect hair, skin, and blood samples to study three eye diseases that affect the~     retina: Best disease, L-ORD, and AMD.~      Eligibility:~        -  Individuals at least 18 years of age who have Best disease, L-ORD, or AMD in at least~          one eye.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  The study requires one visit to the National Eye Institute.~        -  Participants will be screened with a medical and eye disease history. They will also~          have an eye exam.~        -  Participants will provide a hair sample, a blood sample, and a skin biopsy. The hair~          will be collected from the back of the head, and the skin will be collected from the~          inside of the upper arm.~   "
162958|NCT01432834|"~     The purpose of the study was to assess the efficacy of the Allegretto Wave excimer laser and~     the wavefront optimized ablation profile in correcting primarily non-anterior astigmatism~     faults, following laser in-situ keratomileusis (LASIK) and photorefractive keratectomy (PRK).~   "
162959|NCT01432821|"~     The objective of the present study is to assess dopaminergic reactivity with behavioural~     markers (i.e. yawning and blinking) in patients with idiopathic generalized epilepsy compared~     to matched healthy controls, after injection of either low dose of apomorphine or placebo.~      Other parameters will be recorded: biochemical (prolactin, GH) and neurophysiological~     (Spike-Waves Discharge: SWD rating). Safety parameters will be recorded to assess tolerance.~   "
162993|NCT01432366|"~     It can be assumed that there is a link between what the patient feels and thinks about his~     medication and objective measures of disease activity and safety.~   "
162960|NCT01432795|"~     Medical compression stockings are highly effective in the prevention, treatment, and~     secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome.~     Non-adherence to the prescribed compression treatment concerns approximately 40% of patients.~     Elderly patients are often unable to handle stockings in order to put them on properly in the~     morning and to undress in the evening. Gliding aids and stocking butlers are two types of~     tools to facilitate the dressing manoeuvre with medical stockings.~      The present study evaluates four different gliding aids and two different stocking butlers~     to put on three different types of compression stockings. The study is conducted with forty~     consenting subjects with advanced chronic venous insufficiency.~   "
162961|NCT01432782|"~     This study evaluates the effect of botulinum toxin 100 U or saline, injected endoscopically~     in the distal esophagus, on symptoms and manometry pattern in patients with diffuse~     esophageal spasm.~   "
162962|NCT01432769|"~     Effect of enteral nutrition in the outcome of patients has the objective to determine the~     effect of implementing a nutritional support protocol on the outcome of cardiovascular~     surgery patients, the main justification of the study its the prevalence of malnutrition over~     the hospitalized patients and the way this complication influence the treatment efficacy, the~     risk of complications over these patients, the costs, the prognosis, mortality and hospital~     stay.~      This study will be a control clinical trial, randomized and double blind.~   "
162963|NCT01432756|"~     The investigators hypothesize that participants in the worksite parenting program~     intervention will show significantly better parent-child communication than will participants~     in the no-treatment (wait-list) control group.~   "
162964|NCT01432743|"~     Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of~     ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in catheter~     ablation of AF. Integration of a previously acquired image of the left atrium into the~     electroanatomical (EA) map offers several potential advantages, including visualisation of~     the complex anatomy of the left atrium, reduction of fluoroscopy time and improved results .~     The two most widely used systems are Cartomerge (Biosense Webster, etc) and NavX Fusion (SJM,~     etc). Although both systems have been independently validated, their clinical utility has not~     previously been directly compared in a randomised trial~   "
162965|NCT01432730|"~     This is a randomised, double-blind, placebo-controlled, crossover, single centre study of~     gefapixant (AF-219/MK-7264) in subjects with idiopathic chronic cough designed to evaluate~     the effectiveness of gefapixant in reducing daytime objective cough frequency.~   "
162966|NCT01432717|"~     The purpose of this study is to find out whether ACE-536 can be safely given to patients.~     This study will also look to see if ACE-536 increases red blood cells, the cells that carry~     oxygen in the body.~   "
162967|NCT01432704|"~     This is a one-year multi-centre, double blind, placebo controlled, randomized trial~     investigating oral vitamin D3 (Colecalciferol) as an add-on treatment to interferon-beta-1b~     for Multiple Sclerosis (MS). Not less than one month after initiation of therapy with~     interferon beta 1b, MS patients will be randomised to once weekly treatment with peroral~     colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 0.5 mg of vitamin~     D3, or to once weekly peroral treatment with matching placebo. The hypothesis is that vitamin~     D suppresses clinical and MRI activity of MS.~   "
162968|NCT01432691|"~     This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint~     replacement.~   "
162969|NCT01432678|"~     The purpose of this study is to evaluate level of vitamin D in pediatric asthma and~     relationship between vitamin D and level control of asthma.~   "
162970|NCT01432665|"~     The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week~     baseline establishment period, 16 week treatment period and a follow up period for a total of~     26 weeks on study. Subjects are randomly to one of seven treatment arms. The study~     investigates the effective dose of Lybrido in increasing the number of satisfactory sexual~     episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire~     disorder and low sensitivity for sexual cues (30 subjects per group).~   "
162971|NCT01432652|"~     The purpose of this study is to determine the incidence of aspirin resistance in the~     population of vascular surgery patients; and to evaluate the changes in the efficacy of~     aspirin in the first five postoperative days.~   "
162972|NCT01432639|"~     The main purposes of this study is to analyze, in a randomized controlled trial, the effects~     of an exercise-based cardiac rehabilitation program (i) on biomarkers of endothelial~     function, (ii) on biomarkers of inflammation, (iii) on autonomic function, and (iv) on~     arterial stiffness in coronary artery disease patients (CAD). Additionally, the investigators~     aim to analyze the (v) contribution of age and the changes in traditional risk factors to the~     modification of the endothelial dysfunction and inflammation, and (vi) the contribution of~     the changes in inflammatory and endothelial function biomarkers to the modification of~     autonomic function and arterial stiffness.~      The investigators hypothesize that exercise training will improve the autonomic function,~     arterial stiffness and mitigate the endothelial dysfunction and inflammation in CAD patients~     even in the absence of significant changes in traditional risk factors. Thus, the~     investigators expect with the present study to promote, develop and expand the knowledge in~     this field by assessing the impact of exercise on a pool of markers that provide a wide~     picture of the pathophysiological processes underlying CAD.~   "
162973|NCT01432626|"~     Objective: The objective of this pilot study is to characterize the cardiac uptake patterns~     of I-123 mIBG in stress-induced (Takotsubo's) cardiomyopathy.~      Hypothesis: Perturbations in sympathetic innervation are the underlying pathogenesis of~     stress induced cardiomyopathy and will result in abnormalities in I-123 mIBG cardiac imaging.~     Thus, planar and SPECT I-123 MIBG imaging will provide insight into the pathogenesis of~     stress-induced cardiomyopathy, and may lead to the development of more specific diagnostic~     criteria.~      Study design: This proposal is for a prospective pilot study to characterize perturbations in~     cardiac sympathetic innervation in patients with stress induced cardiomyopathy by performing~     planar and SPECT I-123 MIBG imaging during the acute presentation and after recovery of LV~     function.~   "
163265|NCT01428804|"~     The purpose of the study is to investigate the effect of tDCS applied at the anodic left~     DLPFC of patients with resistant depression compared to patients treated with conventional~     therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in~     resistant depression.~   "
162974|NCT01432613|"~     Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An~     appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and a~     specific treatment is needed. Currently the use of muscle MRI (magnetic resonance imaging) in~     departments managing IIM is common. In absence of recommendations fixing their place in the~     diagnostic phase, the practices observed are extremely heterogeneous. This practices~     diversity well reflects the lack of data in the literature, making it impossible to~     appreciate the real contribution of this test. The main aim of this interventional study is~     to evaluate the diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity,~     predictive positive value and predictive negative value) for patients who are suspected to~     suffer from IIM.~   "
162975|NCT01432600|"~     The main purpose of this study is to see whether pomalidomide can help people with myeloma.~     Researchers also want to find out if pomalidomide is safe and tolerable.~   "
162976|NCT01432587|"~     An ongoing trial of diflunisal has been closed for enrollment, thus, patients suitable for~     the study can no longer participate or receive treatment by diflunisal; and patients, who~     have participated in the trial can not continue their treatment. The investigators want to~     continue to monitor the effect of the drug on transthyretin (TTR) amyloidosis in an open~     label observational study.~      Primary endpoint will be a composite score of the manifestations of the disease (Kumamoto~     scale) and secondary end points will be measurements of neurological impairment, heart~     involvement and nutritional status.~   "
162977|NCT01432574|"~     The purpose of this study is to test the effectiveness of the research study vaccine,~     Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human~     Papillomavirus [HPV] infection in men (HIM) Study.~   "
162978|NCT01432561|"~     In order to meet FDA standards of safety and efficacy reporting for most new drugs,~     food-effect bioavailability (the impact that the presence of food in the digestive tract has~     on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the~     site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of the~     rare disease cystinosis that became available in 1994, but there is inadequate knowledge of~     the food-effect on this drug's bioavailability. This study aims to investigate how food~     affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.~   "
162979|NCT01432548|"~     Vascular occlusion is used to reduce blood loss during liver resection (LR), but may cause~     ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver~     disease. This restriction of blood flow (ischemia) and subsequent restoration (reperfusion)~     causes a harm that is called ischemia- reperfusion injury. Injuries sustained during the~     ischemic phase are related to a lack of oxygen to reduce cellular respiratory events can lead~     to, in a few minutes, irreversible damage. Ischemic preconditioning as a technique to protect~     the liver parenchyma during liver resection consists of an initial flow clamping for 10~     minutes, with subsequent reperfusion for 10-15min, followed by a complete portal triad~     clamping during transection.~   "
162980|NCT01432535|"~     This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b~     (Sylatron®) in healthy participants to that in participants with moderate to severe~     impairment of kidney function.~   "
162981|NCT01432522|"~     This study is a preliminary report of pharmacokinetic data of epinephrine administered via~     intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.~   "
162982|NCT01432509|"~     The purpose of this study is to identify in prediabetic subjects, physiopathological changes~     involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type~     2 diabetes risk in this population.~   "
162983|NCT01432496|"~     The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg~     produces better postoperative pain control than Saline nebulization after laparoscopic~     colectomy.~   "
162984|NCT01432483|"~     The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK) to~     patients who are currently on therapy and who have no other suitable treatment options, where~     therapy is requested by their physician.~   "
162985|NCT01432470|"~     Up to 50% of all postmenopausal women, experience vaginal dryness, irritation, burning,~     itching or discomfort, which often make sex to become difficult or painful. These symptoms~     combined are known as vaginal atrophy. Vaginal atrophy is a consequence of the lining tissue~     of the vagina becoming thinner, drier, and less elastic due to the lack of estrogen. In~     addition, vaginal atrophy is associated with an increased pH, which creates an environment~     more susceptible to infections. The mucosal epithelium shows signs of severe atrophy and~     cytological examination demonstrate increased number of the basal and parabasal cells and~     reduced number of superficial cells.~      Estrogen treatment either as hormone replacement therapy or topical application is a common~     treatment for vaginal atrophy. However, some women experience adverse reactions such as~     uterine bleeding, perineal pain and breast pain and many women are also reluctant to use~     estrogens due to a general negative view to this topic in the society.~      Oxytocin is a peptide hormone, which is normally released into the circulation via the~     pituitary. The most well known effects of oxytocin are its roles in female reproduction such~     as facilitation of birth and breast feeding. In addition, oxytocin has in vitro been shown to~     exert positive effects on the proliferation of human vaginal mucosal cells from~     postmenopausal women.~      Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation,~     topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal~     atrophy. In one previous placebo-controlled study on 20 postmenopausal women suffering from~     vaginal atrophy, a gel containing oxytocin for topical intra-vaginal administration was~     applied daily for seven days. The results indicated that for subjects receiving topical~     oxytocin the vaginal atrophy assessed by histological examination was reversed after~     treatment. A similar effect was not seen in the placebo group, which indicated a difference~     between placebo and active treatment. However, the limited number of exposed subjects in this~     pilot study necessitates a larger study in order to generate conclusive proof of concept data~     for the effects of oxytocin on vaginal atrophy.~      Due to the limitations of estrogens in the treatment of vaginal atrophy, many postmenopausal~     women are left without an effective remedy. Hence, there is a need for alternative~     non-estrogenic treatments of this indication. The present study is aiming to investigate the~     efficacy of topical oxytocin in the treatment of vaginal atrophy.~      The main objective of this study is to investigate if topical oxytocin can reverse vaginal~     atrophy, as assessed by cytological examination of the vaginal mucosal epithelium, in~     postmenopausal women after 12 weeks of treatment as compared to placebo.~   "
162986|NCT01432457|"~     A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of~     desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with~     major depressive disorder.~   "
162987|NCT01432444|"~     The purpose of this study is to compare retrospective hospitalization rates of schizophrenic~     patients treated with oral antipsychotics to prospective hospitalization rates of these~     patients treated with IM depot aripiprazole.~   "
162988|NCT01432431|"~     This clinical trial studies spiritual care in improving quality of life of patients,~     caregivers, and hospital staff. Spiritual care may help understand the impact cancer and its~     treatment has on patients, caregivers and hospital staff.~   "
167401|NCT01374503|"~     The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor~     ALX-0651 is safe and effective after single or multiple intravenous administrations to~     healthy male volunteers.~   "
162995|NCT01432340|"~     Influenza is an important cause of acute respiratory infections (ARI) worldwide. Seasonal~     influenza causes an estimated 250,000-500,000 deaths and 3-5 million severe illnesses each~     year (WHO, 2009), and pandemic 2009 H1N1 influenza has caused morbidity and mortality~     worldwide. In Kenya, influenza accounts for up to 50% of all ARI during the peak influenza~     season, based on Kenyan Ministry of Public Health and Sanitation and KEMRI/CDC surveillance~     data. Influenza vaccine has been shown to reduce influenza-associated ARIs in developed~     countries. However, little is know about the effectiveness of influenza vaccine in the~     developing world. In Kenya, a commercial trivalent injectable vaccine is licensed, but less~     than 30,000 doses are sold annually. The International Emerging Infections Program (IEIP)~     under KEMRI/CDC currently conducts population-based disease surveillance (PBDS) for severe~     acute respiratory illness (SARI) and influenza-like illness (ILI) in two sites in Kenya, Lwak~     (Nyanza province) and Kibera (Nairobi). The investigators propose to conduct a three-year~     influenza vaccine effectiveness study using the commercially available southern hemisphere~     seasonal vaccine for 2010, which includes the pandemic 2009 H1N1 component, and for 2011 and~     2012. The study will evaluate the effectiveness of the vaccine in preventing~     laboratory-confirmed influenza, non-specific ARIs at the clinic and household level, and~     secondary influenza infection and secondary ARIs. Our study hypothesis is: Immunizing~     children with influenza vaccine will decrease influenza-associated acute respiratory~     infections among children and may reduce the number of non-specific acute respiratory~     infections in vaccinated children and their household contacts.~   "
162996|NCT01432327|"~     The aim of the study is to assess an increase of daily physical activity from electronic~     self-monitoring, to compare these values to the 10.000 step program, and to compare with~     real-time feedback with and without guidance from a Personal Coach.~   "
162997|NCT01432314|"~     In this study, the investigators are to prospectively evaluate patient's survival, tumor~     response, and safety of RT followed by TACE in Child A patients with unilobar portal vein~     invasion.~   "
162998|NCT01432301|"~     The purpose of this study is to provide emergency treatment of adult and pediatric patients:~        -  Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms~          or~        -  Who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or~          central nervous systems, and/or early-onset, unusually severe adverse reactions (e.g.,~          gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of~          fluorouracil or capecitabine administration.~   "
162999|NCT01432288|"~     This study will measure resting state network central nervous system activity by functional~     magnetic resonance imaging (fMRI) during 4 separate interactions with a clinician. 1.~      Hypothesis 1. Because they are different sensory systems, there will be different patterns of~     Mirror Neuron System (MNS)and Resting State Network (RSN) Central Nervous System (CNS)~     activity for visual vs. tactile stimulation, regardless of Loving Kindness Meditation (LKM).~      Hypothesis 2. Because of unconscious, non-verbal signals, such as the practitioner's facial~     expression and respiratory rate, subjects' patterns of MNS and RSN CNS activity will differ~     for LKM+ vs. LKM- stimulation for both visual and tactile interventions.~      Hypothesis 3. Because there is greater opportunity to detect signals from two sensory systems~     than one, the differences between CNS MNS and RSN activity patterns for LKM+ and LKM- will be~     greater for combined visual + tactile than for either visual or tactile stimulation alone.~   "
163000|NCT01432275|"~     The aim of this study is to evaluate user preference and ease of use of the FreeStyle~     InsuLinx system, compared to current methodology, when used at home by subjects with~     diabetes.~      Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with~     comparator meters.~   "
163001|NCT01432262|"~     The purpose of this study will be to assess the safety, tolerability, and immunogenicity of~     13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50~     years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.~   "
163002|NCT01432249|"~     Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of~     Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication~     approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new~     indication should be provided at minimum 600 subjects administered in the setting of routine~     practice during the initial 4 years after new indication approved.~   "
163003|NCT01432236|"~     The intent of this study is to identify and treat fibromyalgia subjects with comorbid~     depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI~     (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine~     whether pregabalin demonstrates improvement relative to placebo in improving pain associated~     with fibromyalgia.~   "
163004|NCT01432223|"~     The purpose of this study is to evaluate the efficacy in terms of the pathological complete~     response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based~     regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable~     breast cancer.~   "
163005|NCT01432210|"~     Vitamin A is necessary in the human diet. The form of vitamin A found in fruits and~     vegetables is not active and must be converted to the active form in the human body.~     However, information on the ability of humans to absorb and convert vitamin A to the active~     form is still lacking. In this study, the investigators will observe the absorption and~     conversion of vitamin A from orange tomato sauce and/or carrots after a meal with fat (from~     avocado fruit) and a meal without fat. The investigators will also test whether eating these~     foods might protect the blood against damage that could lead to heart disease.~   "
163006|NCT01432197|"~     The aim of this study is to investigate the effect of occupational therapy, in shape of~     activities of daily living, for cancer patients.~   "
163007|NCT01432184|"~     Using the brain and the heart as index organs, perioperative interventions to optimize~     cerebral oxygen saturation and cardiac contractility in high-risk patients undergoing cardiac~     surgery should have a beneficial systemic effect for enhancing global tissue perfusion and~     improve outcomes.~   "
163077|NCT01431274|"~     The overall objective of this study is to assess the efficacy and safety of 52 weeks once~     daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT~     Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the~     RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
163008|NCT01432171|"~     The goal of this clinical research study is to learn if an antiepileptic (anti-seizure)~     treatment will prevent seizures in patients with brain tumors who have not yet had a seizure.~     Anti-seizure drugs are designed to decrease abnormal electrical activity in the brain that~     plays a role in developing seizures.~      In this study, lacosamide will be used as an anti-seizure medication. Lacosamide will be~     compared to a placebo.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
163009|NCT01432158|"~     This is an open-label phase III clinical trial. The purpose of this trial is to investigate~     in detail the kinetics of the immune response to Prevenar-13, a pneumococcal conjugate~     vaccine, compared to Pneumovax-II, a pneumococcal plain polysaccharide vaccine. With their~     consent, healthy adults (n=2 in each group) aged over 18 years who have not received any~     pneumococcal vaccine in the past will receive either vaccine at their first visit. Blood will~     be taken before vaccination and at day 0,1,2,4,6,8,10,12,14,16,18,20,23,26,30,35 as well as~     2,6 and 12 months following vaccination. With specific consent, a small volume of blood will~     be used to store DNA and RNA for analysis of the genetic associations with immune responses~     and adverse reactions to vaccines as well as the RNA expression following a vaccination.~     Serum or plasma will be used to assess antibody level and available whole blood will be used~     for B cell assays and to examine immunoglobulin gene usage in B cells.~   "
163010|NCT01432145|"~     This study will evaluate the efficacy and safety of 6MP in combination with methotrexate in~     patients with breast or ovarian cancer who are known to have a BRCA mutation. 6MP is used~     instead of 6TG as it is converted to the same cytotoxic moiety as 6TG, ie. thioguanine~     nucleotides, but with reduced toxic effects. Low dose methotrexate is used in combination~     with 6MP as it promotes the formation of thioguanine nucleotides.~   "
163011|NCT01432132|"~     The goal of this research study is to understand how patients adjust to appearance and body~     image changes after surgery for head and neck cancer.~   "
163012|NCT01432119|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of selective internal radiation (SIR)-Spheres with yttrium-90 attached and~     cetuximab. Some participants will also take erlotinib with this combination.~      Yttrium-90 microspheres are designed to treat cancer that has spread to the liver.~     SIR-Spheres are designed to deliver the radiation directly to the liver. This radiation may~     cause the tumor cells to die.~      Cetuximab and erlotinib are drugs that are designed to block the epidermal growth factor~     receptor (EGFR). EGFR is a protein that helps cancer cells grow. Blocking the EGFR may stop~     tumors from growing.~   "
163013|NCT01432106|"~     Study purpose: African Americans with hypertension and markers of metabolic syndrome (small~     elevations in blood glucose, triglycerides and or weight) are at a high risk of~     cardiovascular (heart and blood vessel) problems. There is a circulating factor called~     angiotensin II that increases risk and may be more important in African Americans who have up~     to 20 times greater risk of losing kidney function and requiring dialysis. Research~     Investigators, including those at the University of Michigan, found one drug (Ramipril) that~     blocks angiotensin II effects significantly and improves kidney function in African~     Americans.~      The purpose of The SAAVE Study is to determine whether the combination of two new blockers~     (Valsartan and Aliskiren) of angiotensin II, are better able to lower blood pressure, also~     improve some of the risk factors for cardiovascular problems and provide greater protection~     to the heart and kidneys.~   "
163014|NCT01432093|"~     Most people develop high blood sugars following liver transplant that requires treatment with~     insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid~     medications. High blood sugar levels can be treated with a hormone that the body makes called~     insulin. This study is being done to determine if maintaining normal blood sugar levels after~     transplant for as long as needed while in the hospital results in a lesser incidence of~     death, infections, transplanted liver rejection or failure or need for rehospitalization~     within 90 days after transplant.~   "
163015|NCT01432080|"~     For many patients with blood cancers, stem cell transplantation from a family member or from~     an unrelated donor remains the only potentially curative option. Unfortunately, up to 40% of~     patients develop chronic lung disease after the transplant, which substantially increases the~     risk of death in the long-term. Currently, patients with transplant-related lung disease are~     treated with some combination of steroids and other immunosuppressant drugs, but only about 1~     out of 5 improve.~      The importance of our study is that the investigators aim to prevent the development of~     transplant-related chronic lung disease in the first place. Because a strong risk factor for~     such chronic lung disease is a prior viral respiratory tract infection, the investigators~     think there is a window of opportunity to intervene. As soon as cold and flu symptoms~     start, the investigators will treat patients with a combination of drugs aimed at eliminating~     damaging immune responses triggered by the virus. In the absence of such treatment, the~     investigators believe these lung-damaging immune responses would persist even after the virus~     disappears. Our hope is that preventive treatment might avoid the development of chronic lung~     disease, and this would substantially increase long-term survival in our transplant patients.~      This is a pilot study. Once feasibility is established, the investigators will seek to expand~     this study into a definitive clinical trial.~   "
163016|NCT01432067|"~     The investigators will propose to older cancer patients with good prognosis (curative care) a~     randomized trial of adapted physical activity during one year. To increase generalisation of~     the intervention the investigators intend to compare the PNNS advices (the French National~     Nutrition and Health Program) to a program targeted on the own capacities of each patient.~   "
163017|NCT01432054|"~     The objective of this study is to create a Human Tissue Repository to be used as a resource~     for future tissue repair research at KCI USA, Inc.~   "
163039|NCT01431768|"~     This is a open label, prospective, pair comparison, randomised, multi-centre trial. The~     primary aim of this study to is to clinically validate the sensitivity and specificity of the~     Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available~     rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for~     identifying Influenza A infection Polymerase Chain Reaction (PCR).~      The secondary aim is to clinically validate the sensitivity and specificity of the Respirio~     Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.~   "
163018|NCT01432041|"~     Safety in seconds is a randomized controlled trial of a computer tailored Injury Prevention~     program which was conducted in the waiting area of a level 1 pediatric trauma center. A~     computer kiosk was used to randomly assign participants to study groups, collect baseline~     data and generate tailored reports based on responses to assessment items. An intervention~     group received a personalized and stage-tailored safety report and a control group received a~     personalized, but otherwise generic report on other child health topics. Telephone follow-up~     interviews were conducted 2-4 weeks and again 4-6 months after enrollment. Home visits were~     completed for a subset (n=100) of parents who completed the 4-6 month follow-up interview.~     The study aimed to increase knowledge, self reported and observed safety behaviors.~   "
163019|NCT01432028|"~     This is cross-over, randomized clinical trial, with objective to evaluate the effects of~     low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers~     (fibrinogen, von Willebrand factor, c-reactive protein), natriuretic peptide and on~     anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women~     and analyzing polymorphisms in the estrogen receptor gene and FTO polymorphisms~      Patients will be randomized to receive oral hormone treatment or non-oral hormone treatment~      The investigators hypothesis is that a different genotypes in the receptor estrogen gene and~     FTO may have an influences on treatment response in metabolic markers and cardiovascular risk~   "
163020|NCT01432015|"~     Nausea and vomiting are two of the more concerning adverse outcomes associated with~     chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer~     patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with~     carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and~     vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining~     a cancer patient's quality of life.~   "
163021|NCT01432002|"~     The purpose of the study is:~        -  to assess the potential benefits of 18F-[FDG] PET/CT and PET/MRI for operable breast~          cancer in order to define the size and location of the primary tumor, as well as~          axillary, supraclavicular and internal mammary lymph nodes.~        -  to apply the imaging results to the simulation and the radiation treatment planning and~          partial breast for 3-D radiation treatment and partial breast irradiation with intensity~          modulated radiation treatment (IMRT).~   "
163022|NCT01431989|"~     This study is prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods. The volunteers received, in each period, the~     reference or the test formulation, according to the randomization list, under fasting~     conditions, in order to evaluate if the reference and test formulations are bioequivalent.~   "
163023|NCT01431976|"~     This is a multi-center, uncontrolled, open-label study to evaluate the efficacy and safety of~     lamotrigine monotherapy on newly diagnosed typical absence seizure in children and~     adolescents in Japan and South Korea.~      The study period is composed the baseline, fixed escalation phase, escalation phase,~     maintenance phase, taper phase, and post study examination. During the fixed escalation~     phase, the investigational product is administered at 0.3 mg/kg/day for 2 weeks (Week 1 to~     2), followed by 0.6 mg/kg/day for 2 weeks (Week 3 to 4). Subjects thereafter visit the clinic~     once every 1 to 2 weeks during the escalation phase to increase the dose by 0.6 mg/kg/day up~     to a maximum of 10.2 mg/kg/day or 400 mg/day (whichever was less) until patients are~     confirmed to be seizure-free by HV tests for clinical signs. After seizure free is confirmed~     by HV-clinical signs, the dose is increased by one level and HV-EEG (electroencephalography)~     test (first test) is assessed at the next visit. If seizure free is observed by HV-EEG, the~     same dose is administered. Thereafter, HV-EEG (second test) is assessed at the next visit and~     if seizure free is confirmed again, the subjects enter the 12-week maintenance phase. During~     the maintenance phase, patients visit the clinic once every 4 weeks. The dose can be adjusted~     as necessary within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day (whichever was less)~     taking into account the status of seizures and the safety. The investigational product is~     administered once daily (in the evening). However, if the number of tablets is large,~     twice-daily administration (in the morning and evening) is also allowed. After the completion~     of maintenance phase, subjects who have responded to lamotrigine without tolerability issues~     are eligible to enter the extension phase of the study if clinically indicated.~   "
163024|NCT01431963|"~     This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to~     evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed~     epilepsy and those with recurrent epilepsy (currently untreated).~      The study is composed of baseline, escalation phase, maintenance phase, taper phase and post~     study examination. During the escalation phase, the investigational product is administered~     orally at 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks and finally 100 mg/day for 2~     weeks. During the maintenance phase, 200 mg/day is administered orally for 24 weeks. However,~     the dose can be decreased to 100 mg/day if there are safety concerns. Also, if it is~     confirmed that the seizures cannot be controlled at the dose of 200 mg/day, the dose can be~     gradually increased up to 400 mg/day by 50-100 mg/day at intervals of at least 1 week. As a~     rule, lamotrigine should be administered once daily (in the evening), but the dose exceeding~     200 mg/day can be administered in two divided doses (in the morning and evening). After the~     completion of maintenance phase, Japanese subjects who have responded to lamotrigine without~     tolerability issues are eligible to enter an extension phase of the study if indicated, until~     either approval of this indication (monotherapy in epilepsy) or after 24 months after LSLV~     (Last Subject's Last Visit) of the maintenance phase, whichever is sooner.~   "
163025|NCT01431950|"~     A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two~     doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and~     adolescents currently receiving mid to high strength inhaled corticosteroids.~   "
163026|NCT01431937|"~     The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     repeat ascending doses of GSK2018682. The study will also provide further evidence of the~     potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on Absolute~     Lymphocyte Counts (ALC).~   "
163040|NCT01431755|"~     The objectives of this study are to evaluate the pain-relieving effect and safety of adding~     lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained.~     The study products will be administered in the cheek.~   "
163027|NCT01431924|"~     This is an observational retrospective analysis of linked pharmacy and medical claims data~     from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States~     (US) healthcare claims database that is representative of the non-elderly, insurance-carrying~     population, The total population is 35.4 million. The average length of follow-up is 2.7~     years mean (2.2 years median).~      Subjects will be identified in the database that have at least one ICD-9 diagnostic code~     (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the~     index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids.~     Subjects will be followed in the database until they have the event of interest~     (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or~     combination of asthma-related emergency department/hospitalization or asthma-related~     emergency department/hospitalization/oral corticosteroids) or until they are lost to follow~     up whichever comes first. Subjects can be censored if they leave the database, have the event~     of interest, or are dispensed another asthma controller other than the medication of~     interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical~     models adjusting for differences in baseline (pre-index) asthma and patient demographics will~     be used to compare asthma events.~   "
163028|NCT01431911|"~     The timing of initiating short-term treatment for COPD exacerbations with oral~     corticosteroids and/or antibiotic therapy has been shown to influence the recovery time of~     exacerbations with early initiation of exacerbation therapy having a faster symptom recovery~     compared to delayed initiation. While oral corticosteroids and/or antibiotic therapy are~     crucial for immediate exacerbation therapy, maintenance therapy with controller medications~     for COPD has been recommended to reduce the risk of future exacerbations. The initiation of~     maintenance therapy after a COPD exacerbation has been shown to be beneficial in the~     reduction of risk of future exacerbations. However, there is a lack of information on whether~     the timing of this initiation influences the risk of future exacerbations. The following~     study evaluates the impact of early versus delayed initiation of controller medication~     therapy for maintenance treatment following a COPD-related exacerbation on outcomes of future~     exacerbations and costs in patients with COPD.~   "
163029|NCT01431898|"~     This is a research study to evaluate the safety, tolerability and anti-viral activity of~     GS-9669 in patients with Hepatitis C infection.~   "
163030|NCT01431885|"~     Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical~     length to diagnose preterm labor can result in improved outcomes compared to traditional~     diagnosis based on digital examination to measure cervical change.~   "
163031|NCT01431872|"~     The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to~     peak, then decrease gradually as estrogens reach a new lower, but steady level. The~     investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion~     from the osteoblastogenic pathway to the adipogenic pathway.~      The investigators will conduct a longitudinal cohort study of post menopausal women with~     hormone-responsive breast cancer that will be treated AIs. The study will observe~     anthromorphic and serum marker changes during the first year of their treatment.~   "
163032|NCT01431859|"~     Birch pollen allergy is increasingly common. It causes asthma and early season hay fever.~     This is because the body recognises birch pollen and reacts to it, leading to symptoms. Many~     patients with birch allergy get an itchy and/or swollen mouth when they eat fresh fruit~     (apples, pears, peaches, plums etc). Some fruit proteins have a similar structure to birch~     pollen; because of this the body recognises these proteins too causing the immune system to~     respond. This response causes symptoms of itch and swelling inside the mouth and throat. the~     investigators want to find out whether it is possible to get rid of the fruit-induced~     symptoms by using a desensitisation procedure that has been developed for treating the kind~     of hay fever that is caused by birch pollen. Desensitisation involves giving a small~     injection of pollen just under the skin and gradually increasing the amount each week. This~     allows the body to build up a tolerance to the injected protein. When the pollen is then~     encountered in real life the immune system reacts less vigorously so symptoms are less~     severe. This treatment does reduce hay fever symptoms. Our study aims to find out if this~     tolerance is transferred to the fruit proteins enabling patients to eat apples with minimal~     symptoms. Patients will be given apple to eat in a hidden form before treatment and their~     response assessed. They will then receive either active or dummy pollen injections before~     birch pollen season. A few months after completing these injections they will have another~     disguised apple test to see whether their symptoms are any better. If symptoms have improved~     with treatment then this therapy could be offered to patients in the future. This would allow~     them to eat fresh fruit without worrying about unpleasant symptoms and improve their hay~     fever symptoms.~   "
163033|NCT01431846|"~     The study had three parts:~      Part 1: Patients (or their home caretakers) who live outside of Denver and receive their~     primary care at a location other than the Denver VAMC were interviewed after their discharge.~     The interview covered the patient's perspective about the transition of their medical care~     from the Denver VA to their primary care facility.~      Part 2: Primary care providers from the VA facilities that refer patients to the Denver VA~     were interviewed regarding their opinions of transition process from the Denver VA back to~     the primary care VA facilities.~      Part 3: The data from the above interviews were used to develop an intervention to improve~     the transition process from the Denver VA back to the primary care VA facilities.~   "
163034|NCT01431833|"~     Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic~     impairment versus matched control subjects with normal hepatic function.~   "
163035|NCT01431820|"~     The purpose of this study is to determine the safety and efficacy of a topical antifungal~     formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the~     toenails.~   "
163036|NCT01431807|"~     To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.~   "
163037|NCT01431794|"~     This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine~     and nab-paclitaxel with an oral hedgehog inhibitor LDE225. The objective is to assess~     tolerability and the resection rate of patients with borderline resectable pancreatic~     adenocarcinoma who use this treatment.~   "
163078|NCT01431261|"~     The purpose of this study is to test whether a physiotherapy intervention containing pain~     management, general training and specific neck exercises can improve function for patients~     with chronic neck pain.~   "
163041|NCT01431742|"~     This is an open label study of up to approximately 52 weeks duration to assess the safety and~     effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back~     pain.~      BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine~     hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic~     opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled~     substance in the United States.~   "
163042|NCT01431729|"~     Although, oral mucositis has been studied for many years, no available treatment has been~     shown to be effective in preventing or treating mucositis. Based on the observations that~     honey and other products of honeybees have anti-inflammatory, anti-oxidant, anti-microbial~     and wound healing effects, the present study aims at evaluation of the effect of topical~     application of honey and a mixture of honey, beeswax and olive oil-propolis extract, as~     natural products, in treatment of chemotherapy-induced oral mucositis in children with acute~     lymphoblastic leukemia (ALL). This is a randomised controlled clinical trial in which~     eligible patients were randomly assigned into three equal treatment groups. Group 1 received~     15 gm honey applied topically to the affected oral mucosa three times daily. Group 2 received~     5 gm of a mixture of honey, olive oil-propolis extract and bees wax (HOPE) applied topically~     to the oral mucosa three times daily. Group 3 served as control and received a 7.5%~     benzocaine gel applied to the areas of ulcers three times daily.~   "
163043|NCT01431716|"~     This study is investigating the effect of switching from Flolan® to Epoprostenol for~     Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated~     with Flolan®. For this purpose patients being treated for at least 12 months with Flolan®~     will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90~     days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated~     patients. This 90 follow-up will provide clinical evidence on the safety, tolerability,~     efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients~     with pulmonary arterial hypertension.~   "
163044|NCT01431703|"~     It exists a learning curve in using NBI with magnification to differentiating colorectal~     lesions.~   "
163045|NCT01431690|"~     The primary objective of this study is to determine the effect of Epanova® on the~     pharmacokinetic and anticoagulant activity of warfarin.~      The secondary objective of this study is to compare the systemic exposure of EPA and DHA~     following multiple-dose administration of Epanova®, a free fatty acid mixture, to Lovaza®, a~     mixture of fatty acid ethyl esters, under low-fat meal conditions since these products are~     likely to be administered to patients with cardiovascular disease who are recommended to~     consume low-fat meals.~   "
163046|NCT01431677|"~     Background:~      - In individuals as they age, changes in muscle tissue can significantly affect their muscle~     strength and exercise endurance. This process, known as sarcopenia, may lead to decreased~     mobility and physical weakness, which is what we in general refer to as frailty. The causes~     of sarcopenia and why it affects some individuals more than others are not known, but many~     factors influence muscle physiology and function, including metabolic, hormonal,~     environmental, and lifestyle factors. Researchers interested in identifying factors involved~     in the start and progression of sarcopenia need of samples of human muscle tissue and cells~     for laboratory investigations.~      Objectives:~        -  To train researchers in the appropriate procedures for performing muscle biopsies and~          collecting, labeling, and storing the samples.~        -  Develop a data base of specific scientific studies evaluating the physiological and~          metabolic function of muscle that can be used in future studies.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests, and will schedule a date for the muscle biopsy.~        -  Participants will have a muscle biopsy, with tissue and cells taken from the upper part~          of the thigh. A local anesthetic will be given for the procedure. Participants will also~          provide a blood sample and have an electrocardiogram to evaluate heart function.~        -  Participants will have a followup visit 1 week after the biopsy visit to evaluate the~          healing process and provide any further treatment for the affected area, after which~          they may fully resume normal activities.~   "
163047|NCT01431664|"~     RATIONALE: AT9283 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I/IIa clinical trial is studying the side effects and best dose of AT9283~     in treating young patients with relapsed or refractory acute leukemia.~   "
163048|NCT01431651|"~     Obesity has been a global epidemic. Currently, bariatric surgery has been recognized as the~     only successful treatment for morbid obesity. Laparoscopic gastric bypass (LGB) is the~     leading bariatric surgery worldwide including Taiwan, it's resulted in significant weight~     loss and resolution of metabolic co-morbidities in morbidly obese patients .~      However, annoyed Gastro-Intestinal (GI) symptoms are a common complaint after gastric bypass~     like foul smell flatus, oil flatus and over flatus. The aim of this study was to determine~     whether probiotics would improve annoyed GI symptoms after gastric bypass.~      Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial~     microorganisms found in the human gut. They are also called friendly bacteria or good~     bacteria. Probiotics are available to consumers mainly in the form of dietary supplements~     and foods.~   "
163049|NCT01431638|"~     This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety~     and tolerability in patients who have frequent flares of acute gouty arthritis.~   "
163073|NCT01431326|"~     Understudied drugs will be administered to children per standard of care as prescribed by~     their treating caregiver and only biological sample collection during the time of drug~     administration will be involved. A total of approximately 7000 children aged <21 years who~     are receiving these drugs for standard of care will be enrolled and will be followed for up a~     maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of~     understudied drugs for which specific dosing recommendations and safety data are lacking. The~     prescribing of drugs to children will not be part of this protocol. Taking advantage of~     procedures done as part of routine medical care (i.e. blood draws) this study will serve as a~     tool to better understand drug exposure in children receiving these drugs per standard of~     care. The data collected through this initiative will also provide valuable pharmacokinetic~     and dosing information of drugs in different pediatric age groups as well as special~     pediatric populations (i.e. obese).~   "
163050|NCT01431625|"~     AIM: To identify those mechanisms involved in the systemic and muscular response to exercise~     treatment, in two different Obstructive Chronic Pulmonary Disease (COPD) phenotypes~     (emphysema and non-emphysema). The investigators will evaluate the effect of exercise~     training, on exercise outcomes, peripheral muscle strength measures, dyspnea and quality of~     life indices, and markers of systemic inflammation and muscle repair.~      SUBJECTS: The investigators will study 30 COPD patients in GOLD II-IV stages, with~     symptomatic disease. Patients will be differentiated into 2 different phenotypes:~     predominant-emphysema and non-predominant emphysema (15 subjects for each group), according~     to high resolution computed tomography (HRCT) scanning images, and after the specific~     analysis with the MeVisPulmo software. After patients are typified, they will be included in~     the 12- wk training programme. MEASURES(pre&post-training):Basic blood analysis, EKG,~     spirometry, blood gases, pletysmography, gas diffusion, maximal inspiratory and expiratory~     pressure (MIP,MEP), bioimpedanciometry, 1RM test and isometric strength determination, 6-min~     walking test (6MWT), maximal and submaximal cycle-ergometry, and dyspnea using the Mahler's~     Basal and Transitional Dyspnoea Indexes (BDI/TDI) and quality of life (Chronic Respiratory~     Disease Questionnaire [(CRDQ]) evaluation. Besides, the investigators will measure blood PCR~     and cytokines levels (IL6, IL8, IL10, IL12, TNF-α, IGF-1, and MIC-A & MIC-B). Muscle biopsies~     will be made (quadriceps) for detection of TNF-α, TNFR-I, TNFR-II, IGF-1Ea and MGF, IGF-1R,~     genes bound to biogenesis, markers of cell lesion-stress and myosin heavy chains (MyHC) type~     I and II, N-CAM/CD56 and Met & Desmin~   "
163051|NCT01431612|"~     The aim this study was to examine to what degree the slow turnover of lactated Ringer's~     solution during anesthesia and surgery can be prevented by infusing esmolol (a ß1-receptor~     blocker) or phenylephrine in patients undergoing laparoscopic gynecological surgery performed~     under intravenous anesthesia.~   "
163052|NCT01431599|"~     The purpose of this study is to evaluate the early clinical outcome of the short-course~     preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the~     investigators initiated the clinical trial of KROG 11-02.~   "
163053|NCT01431586|"~     This is the first study to be conducted in humans for JDTic, a new chemical entity, with~     evaluations focusing on the safety, tolerability, and pharmacokinetics (PK) of JDTic~     following administration of single oral doses. JDTic is a novel, selective κ opioid receptor~     antagonist and is currently being developed by RTI International as a potential~     pharmacotherapy to treat cocaine dependence. This study has the possibility of identifying~     the maximum tolerated dose in humans and a surrogate measure of JDTic pharmacodynamic (PD)~     activity. Data from this study will be used to plan for and define dose ranges for subsequent~     studies, as well as to identify potential indicators of JDTic pharmacological activity.~   "
163054|NCT01431573|"~     This pilot study seeks to replicate previous findings that sleep deprivation results in~     marked improvement in depression symptoms, as well as to test whether concurrent treatment~     with Light Therapy and Lithium are successful in locking in and maintaining therapeutic~     effects in both bipolar and unipolar depressed subjects.~   "
163055|NCT01431560|"~     The purposes of this study are to compare the outcomes of the biodegradable implants for the~     fixation of ankle fracture and those of metallic implants, and to assess the problems of the~     biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate~     and screws for ankle fracture are not different from those of metallic implants.~   "
163056|NCT01431547|"~     This is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus for~     pediatric participants with advanced solid tumors. This study will have three parts. Part 1~     will find a maximum tolerated dose (MTD) and collect pharmacokinetic (PK) data for~     dalotuzumab alone. Part 2 will find an MTD and collect PK data for dalotuzumab in combination~     with ridaforolimus. Part 3 will be an expansion cohort at the recommended Phase 2 dose (RPTD)~     found in Part 2 to confirm the RPTD and look at the potential efficacy of the combination~     therapy.~   "
163057|NCT01431534|"~     This is a study to find a maximum tolerated dose (MTD) and pharmacokinetic (PK) data for~     ridaforolimus given to participants between the ages of 6 and 17 years with advanced solid~     tumors.~      Study-related visits concluded in August 2013. Participants may continue treatment until they~     meet discontinuation criteria or voluntarily withdraw.~   "
163058|NCT01431521|"~     This study will evaluate changes in liver fat content following multiple oral doses of~     MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease.~     The primary hypothesis of the study is that a multiple-dose administration of MK-4074 200 mg~     twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo~     in adult male and female participants with hepatic steatosis (i.e., on order of 50% reduction~     in hepatic fat with respect to placebo is expected).~   "
163059|NCT01431508|"~     This study is being conducted to evaluate the safety and antihypertensive efficacy of~     MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to~     moderate essential hypertension.~   "
163060|NCT01431495|"~     This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients~     with coronary disease:~        -  Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg~          loading dose or after the last maintenance dose (75 mg).~        -  Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events~          (MACE).~        -  Safety Criteria: severe bleeding (GUSTO scale).~   "
163061|NCT01431482|"~     This study is an evaluation of the composition of human milk and health outcomes in children.~   "
163062|NCT01431469|"~     The purpose is to determine if the consumption of study product has an effect on acute~     respiratory infections and/or diarrheal disease.~   "
163074|NCT01431313|"~     This is a single-center, open label phase II study to evaluate the effect of inhaled nitrite~     delivered in a dose escalation manner on the change in pulmonary vascular resistance (PVR) in~     subjects with pulmonary hypertension undergoing right heart catheterization.~      A total of 50 subjects with a confirmed diagnosis of pulmonary hypertension and meet all~     inclusion/exclusion criteria will be enrolled in the study which will entail a single right~     heart catheterization and nebulized nitrite dose of 45mg with one subsequent dosage of 90 mg.~   "
163101|NCT01430962|"~     The purpose of the study is to determine if there are any differences in yield or safety of~     Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) (a type of~     bronchoscopy with biopsy) performed under general anesthesia versus moderate sedation.~   "
163063|NCT01431456|"~     Rationale:~      After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous~     thromboembolism (VTE) or deep venous thrombosis (DVT) potentially resulting in a fatal~     pulmonary embolism (PE). Two novel agents, dabigatran and rivaroxaban, recently gained market~     authorisation for prevention of venous thromboembolism after knee arthroplasty.~      However, there are no clinical trials with dabigatran and/or rivaroxaban and the comparator~     nadroparin.~      Nadroparin is used in the most Dutch departments of orthopaedic surgery after total knee~     arthroplasty. Also safety of the new oral agents with long term use of 42 days is not~     available for total knee arthroplasty.~      Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on~     safety after total knee arthroplasty (TKA) in a clinical explorative pilot study by observing~     the incidence of major bleeding and clinical relevant non-major bleeding using a standardized~     model of bleeding definitions.~      Objective:~      The primary objective of this study is to compare the clinical safety with long term use of~     the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus~     subcutaneous administered nadroparin by observing the incidence of major bleeding and~     clinical relevant non-major bleeding in patients after knee arthroplasty surgery.~      The secondary objectives of this study are effectivity of the agents, compliance, hospital~     stay, re-hospitalisation, outpatient clinic visits and interventions following complications.~     Additionally, coagulation monitoring, knee flexion range of motion, Knee injury and~     Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS) and relationship between health~     statuses and surgery parameters will be evaluated.~      Study design:~      The study is designed as non-inferiority randomized open label controlled pilot study. A~     total of 150 patients will be included, 50 patients in each treatment group (dabigatran,~     rivaroxaban and nadroparin).~      Study population:~      Patients ≥ 18 years and weighing more than 40 kg, participate in the 'joint care program' for~     primary elective total knee arthroplasty and want to provide signed informed consent are~     eligible for the study.~      Intervention:~      Patients receive subcutaneously nadroparin or oral rivaroxaban or oral dabigatran after knee~     replacement surgery.~      Main study parameters/endpoints:~      The primary safety outcome is the incidence of bleeding events occurring during the study~     period of 135 days (including follow-up). Major bleeding events and clinically relevant~     non-major bleeding events were defined according to accepted guidelines.~   "
163064|NCT01431443|"~     The purpose of this study is to investigate the acute and chronic effect of consumption of~     flavanol-rich chocolate on endothelium function in pregnant women at high risk for~     preeclampsia.~   "
163065|NCT01431430|"~     It has been proposed that the intake of high dose of cholecalciferol may have beneficial non~     classical effects (beside bone health). This could include the reduction of type 2 diabetes~     mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These~     pleiotropic effects are mostly documented by observational and experimental studies or small~     intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as~     circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this~     population is at risk of the previously cited complications.The primary purpose of this study~     is to compare the effects of high dose vs. low dose of cholecalciferol on a composite~     endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer and~     patient death.Renal transplant recipients between 12 and 48 months after transplantation will~     be randomized to blindly receive either high or low dose of cholecalciferol with a follow-up~     of 2 years.~   "
163066|NCT01431417|"~     A lot of shoulder function evaluation scores exist but none has been universally accepted as~     a gold standard.~      Recent studies have demonstrated the potential of computerized movement analysis with~     embedded sensors for objective evaluation of shoulder functional outcome following surgery.~      A very simple testing procedure is possible as just a few repetitions of two simple shoulder~     movements are sufficient. This could potentially facilitate implementation of shoulder~     function movement analysis in current clinical practice.~      However, at the present stage of development, the method needs to be extensively validated.~     This means that the research will intend to determine precisely for which current shoulder~     pathology it can be applied, what the outcome of healthy people is, what the reliability of~     the score is and how it can monitor patient evolution.~   "
163067|NCT01431404|"~     The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203~     liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.~   "
163068|NCT01431391|"~     The main purpose of this study was to determine whether ADT started before or after~     sipuleucel-T led to a better immune system response. This study also evaluated the safety of~     sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of~     sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.~   "
163069|NCT01431378|"~     This study is being performed to confirm that the new technique, Model-Based Iterative~     Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT~     scans compared to current techniques (Filtered Back Projection with Adaptive Statistical~     Iterative Reconstruction (FBP with ASiR) and also to demonstrate that MBIR can improve~     general image quality characteristics at equivalent radiation dose levels.~   "
163070|NCT01431365|"~     Smokers will complete questionnaires and smoking behaviour will be examined. After abstaining~     from smoking for approximately 18 hours, they will be randomized to a moderate intensity~     exercise group or passive sitting group. Smoking behaviour (time to first puff) will be~     assessed following treatment.~   "
163071|NCT01431352|"~     This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory~     Chinese women with PCOS will be recruited, and the randomization will be stratified by each~     participating site. Participants will be randomized into one of the two treatment arms:~     letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a~     day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual~     cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to~     5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of~     the present study is to determine the efficacy of combined treatment with letrozole and CHMG~     on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that~     the combination of letrozole and CHMG is more likely to increase the ovulation rate and~     decrease the miscarriage rate and result in a higher live birth rate in PCOS women than~     letrozole alone.~   "
163072|NCT01431339|"~     The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy)~     of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral~     linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial~     skin or skin structure infections.~   "
163075|NCT01431300|"~     The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography~     of the central veins of the chest, and to determine whether dose reduction can be performed~     while maintaining image quality. This will be a prospective randomized study, in which~     healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram~     (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar.~     Quantitative and qualitative analysis will be performed on the images.~   "
163076|NCT01431287|"~     The overall objective of this study is to assess the efficacy and safety of 52 weeks once~     daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT~     Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the~     RESPIMAT Inhaler) in patients with COPD.~   "
163079|NCT01431248|"~     Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or~     azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in~     stomach upset in some patients, causing them to stop taking the medication. Therefore,~     azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach~     upset is not seen or greatly reduced. The goal of this study is to see if there is a~     difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in~     prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The~     working hypothesis is that there is no difference in the clinical effectiveness between~     antibiotic regimens containing te macrolides azithromycin and erythromycin for prolonging~     latency in PPROM.~   "
163080|NCT01431235|"~     The purpose of this study is to determine if cognitive behavioral therapy is effective in~     treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.~   "
163081|NCT01431222|"~     The primary objective in this randomized trial is to evaluate the safety and efficacy of a~     MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to~     the previous default medical treatment - in a study population who is not amenable for the~     conventional surgical approach as current gold standard.~   "
163082|NCT01431209|"~     This phase II trial studies how well ruxolitinib phosphate works in treating patients with~     diffuse large B-cell or peripheral T-cell non-Hodgkin lymphoma that has returned (relapsed)~     or that does not respond to treatment (refractory) after donor stem cell transplant.~     Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
163083|NCT01431196|"~     Molecular expression in breast cancer (BC) defines special fenotypes with different~     prognostic and predictive features.Since the addition of trastuzumab and lapatinib to~     chemotherapy, HER2 overexpressing tumors have become the best responders to systemic~     therapies, reaching pathologic complete response rates (pCR) around 50%. But HER2 negative~     tumors (luminal A and triple negative) are characterized by low chemosensitivity (luminal A)~     or early distant relapse after diagnosis (triple negative BC) . In this open, prospective,~     non-randomized and multicentric phase II study the investigators include stage II and III~     HER2 negative BC patients that are going to receive neoadjuvant sequential chemotherapy~     Epirubicin+Ciclofosfamide x 4 and then Docetaxel x 4)with an individualized vaccination with~     autologous dendritic cells pulsed with their own tumor. The hypothesis is that the~     reinforcement of the immune system with the autologous dendritic cell vaccination against~     HER2 negative BC could increase pathologic complete responses (pCR) and disease free~     survival(DFS), when added to chemo, surgery and radiation therapy and in a maintenance~     schedule.~   "
163084|NCT01431183|"~     The objective of this study was to assess the feasibility and effectiveness of using a~     statewide immunization information system (IIS) to send seasonal influenza vaccine reminders~     from Local Health Departments (LHDs), targeting children with high-risk conditions.~   "
163085|NCT01431170|"~     The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic~     suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The~     hypothesis of the study is that Besivance™ is as safe and effective as the current standard~     of care for the treatment of nasolacrimal duct obstruction in children.~   "
163086|NCT01431157|"~     Sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and~     symptoms, such as being tired. It can decrease the restfulness of sleep and decreases the~     level of oxygen in the blood. Sleep apnea patients suffer from daytime sleepiness,~     hypertension, coronary artery disease (CAD), stroke, ischemic heart disease, arrhythmias,~     pulmonary hypertension, heart failure, and premature death. There is significant evidence~     suggesting that nighttime decreases in blood oxygen levels are the primary cause of many of~     the abnormalities associated with this disease.~      Epidemiological studies have demonstrated a surprisingly high prevalence of sleep apnea. Mild~     sleep apnea is present in 17% of adults in the general population and moderate to severe~     sleep apnea is present in 5.7% of adults. Among patients with heart failure the prevalence~     skyrockets. Multiple studies have found the prevalence of moderate to severe sleep apnea to~     be anywhere from 11-53% in heart failure patients.~      Continuous positive airway pressure (CPAP) therapy is currently the standard of care for~     sleep apnea sufferers regardless of the severity of their disease. In patients without heart~     failure, CPAP therapy has numerous benefits and several long term studies have reported that~     CPAP causes less cardiovascular disease as well as a long term improvement in cardiovascular~     symptoms and mortality among patient with severe sleep apnea.~      In heart failure patients, CPAP has shown some beneficial short term effects but evidence of~     long term improvements in symptoms and mortality are lacking. Compliance with CPAP therapy~     reduces systolic blood pressure, improves cardiac function, raises oxygen levels, and~     increases exercise tolerance. On the other hand, CPAP has not been shown to affect survival~     or number of hospitalizations in heart failure patients. Moreover, compliance with CPAP is~     often poor and many people cannot tolerate it. This further limits the therapeutic~     effectiveness of this intervention.~      The purpose of this study is to assess whether nocturnal oxygen administration via nasal~     cannula alone can improve outcomes in congestive heart failure patients with moderate to~     severe sleep apnea. The effects of nocturnal oxygen administration will be assessed by using~     biomarkers of heart stress and markers of whole body inflammation.~   "
163087|NCT01431144|"~     This study is a comparison of implant placed and simultaneously grafted with either~     autogenous connective tissue or a connective tissue allograft. The objective is to determine~     the change in soft tissue thickness and determine if a better result is obtained with the~     autograft or the allograft. The hypothesis is that there will be no difference in soft tissue~     thickness over the implant between the autograft and the allograft technique.~   "
163088|NCT01431131|"~     The purpose of this study is to compare two methods of ridge preservation in the maxillary~     anterior esthetic zone to determine the best method to establish adequate bone and soft~     tissue to accommodate implant placement. For the positive control group a mineralized~     cancellous allograft will be placed in the extraction socket. For the test group a~     mineralized cancellous allograft will be placed in the extraction socket plus an additional~     graft will be placed to overlay the facial surface of the socket that will be composed of~     bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional~     change and histologic analysis of the graft material at 4 months post-placement.~   "
163089|NCT01431118|"~     The purpose of the study is:~        -  To investigate the effect of sport-specific stress in the iron metabolism of dragon boat~          athletes~        -  To investigate the effects of sport-specific stress in the activity of pro-hepcidin and~          hepcidin~   "
163102|NCT01430949|"~     The Genesis Feasibility Study will collect clinical information on the use of the Bard~     Over-the-Wire Mesh Ablation System to access and perform electrophysiological mapping,~     cardiac stimulation and radiofrequency ablation in the region of the pulmonary vein (PV)~     ostia for the treatment of patients with Paroxysmal Atrial Fibrillation. Patients will be~     followed up for 12 months to assess the primary safety endpoint of Major Complications (a~     composite safety endpoint)and effectiveness, defined as Long-Term Success (freedom from~     recurrent atrial arrhythmia.~   "
163090|NCT01431105|"~     Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the~     developed world. Despite available treatment, 25% of children in San Diego County~     appropriately treated for KD develop coronary artery abnormalities that could lead to~     complications later in life, including heart attack. Although investigators can identify~     children with KD that have these coronary artery abnormalities, there is no approved~     additional treatment to decrease coronary artery inflammation and arrest or prevent damage to~     the coronary arteries. Inflammation and damage to the arterial wall is central to these~     coronary artery abnormalities. Statins, a class of drugs that is known for lowering~     cholesterol, have also been shown to decrease inflammation in general as well as at the level~     of the vessel wall. Therefore, the investigators propose to study the safety of the drug~     atorvastatin in children with coronary artery abnormalities from KD.~   "
163091|NCT01431092|"~     In this trial, researchers aim to investigate if prolonged-release melatonin can facilitate~     the withdrawal of chronic benzodiazepine administration in patients with schizophrenia.~     Furthermore, researchers will investigate the association of benzodiazepine dose reduction~     with the following clinically important variables: sleep, psychophysiology, cognition, social~     function, and quality of life.~   "
163092|NCT01431079|"~     The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV)~     vaccine acceptability among college men based on the Health Belief Model through focus~     groups, (2) triangulate focus group results with a prior quantitative study in developing an~     intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3)~     test the efficacy of the above intervention based on the Health Belief Model by comparing it~     to a knowledge-based intervention. Approximately five focus groups with ten participants in~     each group with college students in the ages 18-25 years will be conducted at a large~     Midwestern University for the qualitative piece. Data will be analyzed for categories and~     triangulated with previous study to develop a theory based intervention. For the quantitative~     piece a randomized controlled design with 45 participants in each arm (theory based~     intervention and knowledge based intervention) will be implemented.~   "
163093|NCT01431066|"~     Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals~     in the workplace who must stand for prolonged periods of time, and athletes. It can be~     disabling. There is no single accepted treatment course that is recommended in the~     literature.~      The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a~     treatment option in chronic soft-tissue injury due to its ability to reduce pain and~     inflammation.~      The proposed study will investigate the efficacy of the use of a PRFE device for the~     treatment of chronic heel pain using a double blind randomized placebo controlled design~     study.~   "
163094|NCT01431053|"~     This is a phase II study to assess efficacy/safety of Exemestane with or without Aspirin as~     the adjuvant treatment in postmenopausal breast cancer patients.~   "
163095|NCT01431040|"~     Preoperative bowel preparation for surgical management of pelvic floor disorders is performed~     inconsistently, and includes no prep, the use of dietary changes or bowel altering~     interventions. Retrospective studies of emergency colonic surgery first demonstrated a low~     rate of infectious complications without a bowel prep. Recently, data supporting the routine~     use of mechanical cleansing for elective colorectal surgery has demonstrated the surgical~     outcomes are similar between patients that undergo a bowel preparation versus those that do~     not, indicating that the long held dogma of mechanical bowel preparation should be used~     selectively. Despite routine use, there is a paucity of literature addressing the approach~     to, and/or need for preoperative bowel management at the time of vaginal reconstructive or~     obliterative surgery. The majority of the pelvic floor disorder population is older, tending~     to have more bowel dysfunction (especially symptoms of constipation) than younger women.~      The aim of this study is to evaluate preoperative bowel management strategy as it relates to~     the total care of the vaginal surgery patients' intra-and post-operative bowel function and~     overall patient experience. Two commonly used pre-operative bowel prep strategies: no~     preoperative bowel prep versus clear fluids and 2-enema prep. The aim is to assess the value~     of bowel preparation or diet change in vaginal surgery, both from the physician's and~     patient's point of view. In this pilot study, subjects are randomized to either a clear~     liquid diet the day prior to surgery with 2 enemas and nothing by mouth (NPO) after midnight,~     or NPO after midnight without any dietary changes or enemas.~      Our aims are:~      *Primary - To assess the surgeons' objective intraoperative evaluation of the effects of~     bowel preparation (adequate visualization, stooling during case, difficulty with bowel~     handling) *Secondary - (1)To characterize the patients' experience and acceptance of~     preoperative bowel management regimen versus no preoperative bowel preparation(2) To~     characterize the patients' postoperative experience and determine if the preoperative bowel~     regimen affects time to first bowel movement/first normal stool as well as stool experience~     as recorded by bowel diary (3)Evaluate the incidence of complications between the two groups~     (4)Characterize other descriptive qualities of the patients' operative experience(duration of~     case, length of hospital stay)~   "
163096|NCT01431027|"~     Diastolic dysfunction refers to abnormal mechanical properties of the myocardium and includes~     abnormal LV diastolic distensibility, impaired filling and slow or delayed relaxation-~     regardless of whether the ejection fraction is normal or depressed and whether the patient is~     asymptomatic or symptomatic. Epidemiologic studies have demonstrated high prevalence of~     diastolic heart failure (DHF). The quality of life of these patients is impaired and the~     clinical outcomes are similar to those with heart failure with systolic dysfunction.~     Therefore diastolic dysfunction has significant adverse economic impact that is expected to~     grow further with time. Clinical characteristics alone may not be sufficient to diagnose~     diastolic dysfunction. A number of invasive and non-invasive parameters have been proposed to~     diagnose diastolic dysfunction. Most of the presently used non-invasive parameters have a~     number of limitations. High fidelity measurement of the left ventricular pressures is needed~     to accurately diagnose diastolic dysfunction. Obtaining it in routine clinical practice is~     impractical.~      In this protocol the investigators have proposed a novel non-invasive parameter called~     'Torsional Hysteresis' as a measure of diastolic function. This will be measured using~     non-invasive cardiac MRI technique. During left ventricular contraction and relaxation,~     myocardium deforms. During cardiac cycle the myocardium goes back to baseline state prior to~     beginning of each contraction. However the rate with which it returns to the baseline state~     is variable. Torsion indicates relative wringing motion of the ventricle around a left~     ventricular axis and is a global parameter of left ventricular deformation. The parameters~     have defined a new parameter called torsional hysteresis based on non invasive cardiac MRI~     assessment. The parameters have hypothesized that for diastolic dysfunction, the torsional~     hysteresis area is increased as compared to no diastolic dysfunction group.~   "
163097|NCT01431014|"~     Postoperative swelling is one of most common concerns to plastic and oromaxillary surgeons~     after orthognathic surgery. The purpose of this study is to develop a steroid regimen~     protocol for minimizing postoperative facial swelling after orthognathic surgery.~   "
163098|NCT01431001|"~     The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive~     transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.~   "
163099|NCT01430988|"~     The purpose of the current study is proposed to prospectively assess how accurately the~     BrainScope® Ahead™ M-100 can distinguish risk categories for acute head injury.~   "
163100|NCT01430975|"~     This study is to be performed at two clinical sites where patients received CardioGen-82~     during the time period January to June, 2011 and where patients were scanned chronologically~     near to the index patients (2 days before or after). Of these, it is planned that at least 30~     patients will be entered in this trial. Index patient is the term applied to individuals who~     had radiation spectra indicative of Sr-82 and Sr-85 detected by hand-held survey meters.~   "
163104|NCT01430923|"~     The purpose of this study is to:~        -  To evaluate the efficacy of Refrigeration-Free Latanoprost compared to Latanoprost~          stored at refrigeration temperature with respect to the diurnal intraocular pressure~          (IOP) change from baseline after 3 months of therapy in patients with open-angle~          glaucoma (OAG) or ocular hypertension.~        -  To evaluate the safety and tolerability of Refrigeration-Free Latanoprost in patients~          with open-angle glaucoma (OAG) or ocular hypertension.~   "
163105|NCT01430910|"~     This is a randomised study divided into 2 parts. Part A investigates the effect of prolonged~     dosing (ten days) with Avibactam and Ceftazidime when given together and how this will effect~     how much Avibactam and Ceftazidime enters the blood. Part B investigates how much Avibactam~     (NXL104) and Ceftazidime enter the blood when Avibactam and Ceftazidine are given separately~     or together intravenously.~   "
163106|NCT01430897|"~     Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in~     d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the~     assessment of the right ventricle (RV).~      In this study the investigators sought to evaluate systemic RV myocardial mass and function~     after AS for d-TGA and to analyze the role of excessive hypertrophy for ventricular function~     under special consideration of the interventricular septal (IVS) movement.~   "
163107|NCT01430884|"~     During elective percutaneous coronary intervention (PCI), both proximal and distal protection~     devices are used. The distal occlusion protection device temporarily occludes the vessel~     distal to the lesion during the intervention, thereby capturing both particular debris and~     soluble substances released from the lesion such that they can be aspirated and prevented~     from reaching the coronary microcirculation. Rather than simply discarding the material which~     is retrieved from use of protection devices, the investigators have recently taken advantage~     of this situation, sampled the particulate and soluble material and subjected it to a variety~     of analyses with the ultimate goal to have a better insight into the respective plaque~     composition and to correlate it to the individual imaging and clinical data. On the basis of~     such information the investigators aim to better understand the pathophysiology of plaque~     vulnerability and to possibly predict the clinical development of the individual patient.~   "
163108|NCT01430871|"~     Serotonin has recently been identified as a major regulator of bone formation. Gut-derived~     serotonin inhibits bone formation, and early animal studies have shown that inhibition of~     gut-derived serotonin has anabolic effects on bone in ovariectomised rodents. This pathway~     has potential to be developed as a new anabolic treatment for osteoporosis in humans.~      Carcinoid neuro-endocrine tumours produce very high levels of serotonin, and so it might be~     expected that patients with carcinoid disease would have reduced bone formation, low bone~     mass and fractures. However, this has not been apparent in clinical practice. There may be a~     discrepancy between rodent models and human disease. This study aims to identify whether~     patients with carcinoid disease have reduced bone mass, reduced bone formation or high~     fracture rates. The investigators will conduct a cross-sectional observational case-control~     study of patients with carcinoid disease in the Sheffield neuro-endocrine tumour clinic and~     gender-, age- and body mass index (BMI)-matched controls.~   "
163109|NCT01430858|"~     The overall aim of this study is to test the hypothesis that vibration exercise can induce~     higher than normal bone strains and strain rates than are experienced during habitual~     locomotor activities.~      The investigators plan to study healthy young volunteers to:~        1. Determine the relationship between tibial bone strain and~             -  the frequency and amplitude of vibration therapy~             -  a range of habitual locomotor activities;~        2. Determine the transmission of vibrations during vibration therapy, in terms of~             -  amplitude attenuation and phase shift of positional coordinates and accelerations~               at anatomic landmarks along the lower leg and other skeletal sites~             -  the relationship between these and different frequencies and amplitudes of~               vibration therapy;~        3. Determine the muscle power in the lower limb associated with various habitual locomotor~          activities and its relationship to the measured tibial bone strain.~      The investigators subsequently hope to use the data captured in this experiment to develop a~     QCT-based finite element (FE) model of the human lower limb (tibia, fibula and foot). The~     investigators will then validate this model in relation to the characteristics (amplitude and~     phase shift) of the measured tibial bone strain and transmission of vibrations to the~     different anatomical landmarks during vibration therapy.~   "
163110|NCT01430845|"~     The purpose of this study is to find the relationship between the stage and quality of~     developmental delay during infancy and toddler age, and the final diagnosis that the child~     gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders).~   "
163111|NCT01430832|"~     The purpose of this study is to assess the emotional well being of mothers to preterm infants~     with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will~     be taken into consideration. In addition, the correlation between the infant's development~     and the mother's emotional state will be analyzed.~   "
163112|NCT01430819|"~     The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012~     formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and~     older.~      Objectives:~        -  To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥~          65 years of age.~        -  To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among~          adults ≥ 65 years of age.~   "
163113|NCT01430806|"~     Recurrent ICD shocks are a serious problem in pts with ICD. Treatment failure with other~     antiarrhythmics and ablation are common. Dronedarone is a new antiarrhythmic drug with ion~     channel properties similar to amiodarone.~      Several case reports have shown promising results with Dronedarone for this patient~     population.~   "
163161|NCT01430182|"~     The purpose of this study is to determine whether, for surgery of the tibia, one dose of~     methadone provides better control of pain afterward as compared to morphine, which is the~     usual drug given to control pain after surgery. Immediately after the beginning of general~     anesthesia (intraoperatively), subjects will receive one dose of either methadone or~     morphine, in the amount of 0.2 milligrams per kilogram of body weight, intravenously.~      The primary hypothesis is that, subjects who receive one dose of methadone intraoperatively~     will require less pain medicine than subjects who receive one dose of morphine~     intraoperatively.~   "
163114|NCT01430793|"~     The purpose of the study is determination of effective vitamin D replacement strategy in~     vitamin D deficiency states with currently available preparations in Pakistan & to determine~     the cost effective monitoring strategy with urinary calcium excretion serving as a surrogate~     marker of achievement of vitamin D sufficiency state.~      The study will be conducted at the out-patient Endocrinology Clinics of the Aga Khan~     University Hospital, Karachi, Pakistan. All patients seen in endocrine clinics with Vitamin D~     level less than 20 ng and do not have any of exclusion criteria mentioned below will be~     eligible for recruitment in the study. The study participants will be randomly assigned into~     4 groups for intervention to receive intramuscular or oral Vitamin D in 200,000 or 600,000~     units as per group allocation. Each group will comprise of 25 participants.~      Group 1: Vitamin D3 600,000 units IM and then every 2 monthly for 2 times if levels remain <~     30 ng/ml.~      Group 2: Vitamin D3 600,000 units orally and then every 2 monthly for 2 times if levels~     remain < 30 ng/ml.~      Group 3: Vitamin D3 200,000 units IM initially and then every 2 monthly for 2 months if~     levels remain < 30 ng/ml.~      Group 4: Vitamin D3 200,000 units orally initially and then every 2 monthly for 2 times if~     levels remain < 30 ng/ml.~      All patients will be prescribed elemental Calcium 1 gram /day. Vitamin D levels along with~     the other biochemical parameter and random urine for calcium & creatinine will be checked at~     00, 02, 04, 06 and 12 months.~   "
163115|NCT01430780|"~     Basic studies has showed that sustained use of nitrates might associated with adverse effects~     on vascular function mediated by an increase in nitrate-induced oxidative stress. But it~     remains unclear whether oxidative stress increases with endothelial function impairment in~     patients with coronary artery disease (CAD) during administration of long-term oral nitrates.~     The investigators evaluated whether administration of long-term isosorbide mononitrate (ISMN)~     treatment was associated with oxidative stress increase and endothelial function impairment~     in patients with CAD.~   "
163116|NCT01430767|"~     Poor adherence is a common reason for treatment failure in many fields of medicine, and~     likely affects common psychiatric treatments as well. Members of the present study team have~     used Medication Event Monitoring System (MEMS®) caps effectively to objectively monitor~     adherence in skin disease, and have shown that they provide a much more accurate measure of~     adherence behavior than self-reports, pill counts, or serum drug concentrations. The present~     study will use MEMS® caps to measure adherence in 10 patients with depression and 10 patients~     with attention-deficit hyperactivity disorder (ADHD) from a student clinic population. The~     aims will be to show the usefulness of MEMS® caps in measuring adherence to psychiatric~     treatment, and gather data on typical adherence rates for depression and ADHD patients on~     typical treatment regimens. The data obtained will be used to inform future studies that use~     an intervention to improve adherence behavior and ultimately disease outcomes.~   "
163117|NCT01430754|"~     The purpose of this study is to evaluate the maintenance effect and safety of 20 mg~     tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.~   "
163118|NCT01430741|"~     A major goal for the Department of Veterans Affairs is to end Veteran homelessness by 2015.~     The VA's largest homelessness initiative is the joint Departments of Housing and Urban~     Development (HUD) and Veterans Affairs (VA) Supportive Housing program (HUD-VASH), which has~     been expanded greatly over recent years via the allocation of 30,000 Housing First vouchers~     between 2008 and 2010 and increased funding to hire 1,000 new program case managers. However,~     recent expansion has resulted in a number of implementation challenges including delays in~     the distribution of housing vouchers and dropout among program participants (25% of those~     housed in HUD-VASH drop out within a year). Much of this dropout can be attributed to~     untreated issues facing many Veterans enrolled in HUD-VASH. The most common among these~     untreated issues are mental health and substance use disorders. The presence of these~     disorders is due in large part to the fact that much of HUD-VASH case management focuses on~     housing placement and maintenance, with limited attention to mental health, substance abuse,~     and other related psychosocial issues, which when left untreated, negatively impacts voucher~     distribution and housing stability. This project will test an implementation model-Getting To~     Outcomes (GTO)-designed to assist in the delivery of an intervention for Veterans with~     co-occurring mental health and substance use disorders (MISSION-Vet) in the HUD-VASH program.~     The proposed study will compare implementation of MISSION-Vet currently being planned through~     VA Office of Patient Care Services to an enhanced approach using the GTO model. Thus, this~     project can contribute to ending all Veteran homelessness by 2015, a pledge made by President~     Obama.~   "
163119|NCT01430728|"~     The purpose of this study is to examine the range of cerebral tissue oxygen saturation in~     healthy and sick very low birthweight infants during the first 72 hours of life.~   "
163120|NCT01430715|"~     The increasing use of sedentary screen-based activities (SBAs) has been most recently blamed~     for children and adolescents' lack of engagement in physical activity (PA). Studies indicate~     a large portion of children participate high-levels of sedentary SBAs and the sedentary SBAs~     appear to compete for time to engage in PA. If sedentary behavior is a substitute for PA, to~     help increase PA, strategies need to be put into place that helps to decrease sedentary~     behaviors.~      One modification to sedentary videogames that may increase PA in children is to alter~     sedentary videogames so that the videogames actually provide an option to engage in PA,~     rather than to be sedentary. These types of games then don't compete with PA, but actually~     are a source of PA. These types of videogames are called active video games (AVG) or~     Exer-gaming. Previous research demonstrates that energy-expenditure (EE) in AVG play is~     comparable to moderate-intensity walking and produce greater EE than sedentary SBAs. However,~     previous studies have been limited to measuring EE in AVG play to walking either on a~     treadmill or in a structured setting. Studies have not investigated the EE of AVG play~     compared to the EE in free-living outdoor play. Thus, the purpose of the proposed study is to~     determine whether a greater EE is released during AVG play compared to free-living, outdoor~     play in children.~   "
163204|NCT01429610|"~     The investigators would like to propose a phase-2 prospective multicenter trial evaluating~     the efficacy of rituximab combination with our current chemotherapy strategy for adult Acute~     Lymphoblastic Leukemia (ALL), in order to prove out whether the addition of rituximab during~     induction, consolidation, and post-alloHCT status can improve the outcome in terms of~     relapse-free survival (RFS) when compared with our prior data as a historical control.~   "
163121|NCT01430702|"~     Care transition interventions have been successful in reducing medication-related problems~     and associated rehospitalization primarily by focusing on medication reconciliation conducted~     by trained healthcare professionals. Programs to improve the medication reconciliation~     process have largely been effective, but have limitations including the expense associated~     with recruiting, training, and retaining care transition healthcare professionals (e.g.,~     nurses and nurse practitioners) the ability to provide services within a finite geographic~     area, and the retrospective nature of the reconciliation process which usually occurs in the~     home following hospital discharge. Our short-term objective is to use Pennsylvania Department~     of Aging resources to assess the feasibility of using a telemedicine medication delivery unit~     for frail older adults that require medication assistance in their home immediately following~     an acute hospitalization. As part of this feasibility assessment, the investigators will~     assess (1) recruitment process and procedures, (2) data collection procedures, (3) resource~     utilization, (4) drop-out rates, (5) acceptability and usability of the EMMA® telemedicine~     medication delivery unit, (6) medication adherence, and (7) medication-reconciliation errors~     during transition from hospital to home.~   "
163122|NCT01430689|"~     The Center for Vaccine Development - Mali is interested in learning if vaccinating a pregnant~     woman against influenza will protect her infant against this disease. The investigators know~     that influenza infection, the flu, affects pregnant women and their infants in Mali. The~     illness known as flu is caused by a germ (virus) that is passed easily among people. The flu~     causes symptoms such as fever, cough, sore throat, runny nose, and body aches. Certain groups~     of people, such as pregnant women and infants, are at risk for having severe disease when~     they get the flu. Vaccination against influenza is not routinely available to pregnant women~     in Mali although it is recommended.~      Women who wish to participate will have 5 visits to the clinic and weekly visits to the home~     to follow the health of the woman and her infant when it is born. The investigators will also~     ask permission to make weekly visits to all children under 5 years of age to follow their~     health as it relates to influenza infection.~   "
163123|NCT01430676|"~     The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters.~     The aim of present study is to use large-scale data from DVHD to uncover risk factors for~     readmission, reoperation (any indication), death and reoperation for recurrence after~     incisional hernia repair.~   "
163124|NCT01430663|"~     Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with~     hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL)~     samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is~     unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested~     PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at~     high risk of PA.~   "
163125|NCT01430650|"~     The aim of this trial is compare two different endometrial priming protocols~        -  women that receive oral estrogens~        -  women that receive transdermal estrogens~   "
163126|NCT01430637|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is studying genes in samples from younger patients with~     desmoplastic small round cell tumor registered on COG-D9902 or COG-ABTR01B1.~   "
163127|NCT01430624|"~     The purpose of this study is to evaluate whether a brief intervention in video format, that~     includes education about reactions to assault and modeling of adaptive coping strategies,~     designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of~     sexual assault at the time of receipt of post assault medical care is associated with better~     post-assault outcomes as compared to a comparable length video that includes pleasant imagery~     and relaxation instruction or standard care.~   "
163128|NCT01430611|"~     This study is part of the post-licensure commitment to evaluate the safety and immunogenicity~     of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.~      Primary Objective:~      To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30~     days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide~     Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C)~     Polysaccharide Vaccine.~      Secondary Objective:~        -  To describe the immunogenicity for serogroups A and C, 30 days after administration of~          the study vaccines given as a single dose.~        -  To describe the full reactogenicity profile after administration of the study vaccines~          given as a single dose.~   "
163129|NCT01430598|"~     The investigators aim to establish whether completing a subacromial decompression before or~     after repair of a complete rotator cuff tear has any clinical significance. Both the~     arthroscopic decompression and rotator cuff repair will be completed during the same surgical~     date. The investigators null hypothesis contends that full-thickness rotator cuff tear repair~     performed before versus after subacromial decompression will not influence patient's~     post-operative pain or functionality.~   "
163130|NCT01430585|"~     PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis~     that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or~     acquired resistance to hormonal therapy and restore hormone sensitivity in high risk (high~     Ki-67) patient population of hormone-sensitive breast cancers. In addition, Ki-67, a marker~     of cellular proliferation, could be used to select those patients who benefit from treatment~     with a PI3K-pathway inhibitor.~   "
163131|NCT01430572|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients~     with advanced cancer. The safety of these drugs will also be studied.~      Pazopanib is designed to block different receptors in the cancer cells that ultimately are~     responsible for the growth of the tumor and its blood vessels.~      Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also~     involved in cancer growth.~   "
163132|NCT01430559|"~     This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index~     (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will~     also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis~     in this population.~   "
163133|NCT01430546|"~     The purpose of this study is to quantify the burden of treatment in relapsed or refractory~     multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.~   "
163136|NCT01430507|"~     Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that~     causes progressive damage to joints of the body, affecting the functional capacity. Effective~     management of patients with RA requires a multidisciplinary approach. Despite the various~     combinations, there is a significant population of RA patients who are not responding to~     these combinations or showing inadequate response to methotrexate alone. Hence, there is a~     need for a unique combination of drugs targeting different pathological process to yield the~     best results in those patients where prognosis is poor. Combination of revamilast with first~     line therapy like methotrexate could provide better treatment options to a larger population~     of RA patients having moderate to severe disease and who are inadequately controlled on one~     or the other DMARDs.~      This is randomized, double-blind, placebo-controlled, parallel group study. The study will~     include patients with active RA receiving stable and maximum tolerated dose of MTX.~      Patients will be recruited after providing written informed consent. After screening and run~     in period (single blind placebo for 4 weeks), patients will be randomized (meeting~     randomization criteria) in 1:2:2:2 ratios to receive either one of three doses (Low, Medium~     and High) of revamilast or placebo along with MTX.~      The primary objective of the study is to determine the percentage of patients achieving ACR20~     response at 12 weeks. Secondary objectives include determining percentage of patients with~     ACR50 and ACR70 response, change in DAS-28 score, change in serum CRP and ESR values and~     frequency and use of rescue medication.~      During the treatment period, there will be 5 further study visits at week 2, week 4, week 8,~     week 12, for efficacy, safety and tolerability assessment and visit at week 14 will be follow~     up visit.~   "
163137|NCT01430494|"~     To collect characteristics of patients with ADPKD across a broad population, over time to~     better understand disease progression (signs, symptoms and outcomes). Association with total~     kidney volume changes and other measures of disease progression will be determined in order~     to identify a population at increased risk for disease progression. The economic and quality~     life impact of ADPKD will be assessed. Subjects who terminated participation early from~     clinical trials with tolvaptan may also be followed.~   "
163138|NCT01430481|"~     The aim of this study is to compare three combinations of preparations in a comparative trial~     program on rosehip powder for knee OA. The trial is a comparative, 12-week, randomized,~     double-blind, active-controlled trial, designed to determine the comparative efficacy and~     safety of these preparations in patients with pain from knee OA.~   "
163139|NCT01430468|"~     This is a non blinded prospective randomized clinical trial to define the efficacy of a new~     technology developed at the Cleveland Clinic to improve the positioning of the glenoid~     component in total shoulder arthroplasty. The Cleveland Clinic research team has worked on~     the development and validation of this new technology for the last six years. The~     investigators have validated the pre-operative planning software and published the results in~     the peer review literature (1, 7, 8, 9). The investigators have used this software in the~     planning of total shoulder surgery over the last three years. The investigators have~     validated the accuracy and reproducibility of the patient-specific instrumentation in both~     cadaver shoulders and Sawbones models of the shoulder using multiple surgeons. These studies~     also validated our ability to precisely measure component position using 3D CT scan imaging~     after placement of the implants in a pre-clinical cadaver study, thereby validating our~     ability to accurately measure and compare component position between the groups described in~     this proposed clinical trial. The investigators have also proven the ability of the software~     and techniques to produce an accurate representation of the glenoid morphology in patients~     with osteoarthritis or rotator cuff deficient arthritis in 13 patients. This was an IRB~     approved patient safety study performed at the Cleveland Clinic. The investigators have~     performed extensive studies of the materials and processes for the fabrication, sterilization~     and packaging of the patient specific instruments. The investigators have selected materials~     and processes that have met all of the FDA requirements for use of these materials and~     processes as clinical devices in vivo. These devices (non implanted instruments) are~     generally classified by FDA as a Class I device not having significant clinical risk. The~     investigators have studied the materials and process to produce accurate instruments that~     meet the clinical specification for fit onto the surrogate glenoid surfaces and maintain this~     shape and fit after sterilization. These same patient specific instruments have been tested~     in pre-clinical trials (Sawbones and Cadavers), demonstrating their ability to perform the~     functions specified with a high level of accuracy and much better than the use of standard~     generic instruments.~   "
163140|NCT01430455|"~     This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective~     treatment of bipolar depression. New treatments are needed, as there is little evidence that~     standard antidepressants are effective in treating this condition, and the two antipsychotic~     medications that have indications for bipolar depression can cause substantial side effects.~     This study will focus specifically on currently depressed outpatients having a bipolar~     history for whom at least one standard antidepressant medication was ineffective. Patients~     will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.~   "
163141|NCT01430442|"~     The purpose of this study is the exploration of a wide range of BMS-927711 doses that will~     reveal at least one dose that is safe and clinically superior to placebo in the treatment of~     acute migraine.~   "
163142|NCT01430429|"~     The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in~     primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.~   "
163143|NCT01430416|"~     This study has two parts, dose escalation and dose expansion. For dose escalation, the~     primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with~     uveal melanoma. For dose expansion, the primary objective is to characterize the safety and~     tolerability of the MTD of AEB071 in patients with uveal melanoma.~   "
163144|NCT01430403|"~     The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments ―~     omalizumab, corticosteroid therapy boost, and placebo ― in reducing fall exacerbations in~     inner-city children and adolescents with allergic persistent asthma when initiated~     approximately 4 -6 weeks prior to the start of the first day of each participant's school~     year.~   "
163145|NCT01430390|"~     The purpose of this study is to test the safety of giving the patient special cells from a~     donor called Modified T-cells. The goal is to find a safe dose of modified T-cells for~     patients with relapsed B cell leukemia or lymphoma after a blood SCT. The investigators also~     want to find out what effects these T-cells have on the patient and the disease.~   "
163146|NCT01430377|"~     The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous~     coronary intervention (PCI) is still not established. The predilatation could potentially~     damage SB ostium by vessel dissection, making subsequent wiring problematic. However,~     predilatation could eliminate SB ostial stenosis obviating need for further SB treatment~     after main vessel stent implantation. The aim of the study is to assess in random fashion the~     periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and~     without SB predilatation.~   "
163147|NCT01430364|"~     Study aims: to compare two intervention strategies for bifurcation treatment - provisional~     T-stenting (PTS) with drug-eluting stent (sirolimus eluting), with kissing balloon inflation~     at the end of procedure - the best treatment strategy at the moment, with stenting of~     bifurcation lesions with dedicated bifurcation drug-eluting stent BiOSS Lym.~   "
163205|NCT01429597|"~     Primary objective and endpoint is the analysis of the long-term course of lyso-Gb3 and its~     clinical correlation to the progression of the cardiomyopathy in N215S-Fabry patients.~   "
163305|NCT01428284|"~     The purpose of this study is to assess the effects of multiple doses of probenecid on the~     multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers.~     Safety and tolerability will also be assessed.~   "
163148|NCT01430351|"~     The goal of this clinical research study is to find the highest tolerable dose of~     temozolomide in combination with memantine, mefloquine, and/or metformin that can be given to~     patients with glioblastoma who have already been given radiation and chemotherapy in~     combination. The safety of these drug combinations will also be studied.~      Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of~     cells). The damaged DNA may cause tumor cell death.~      Memantine is designed to block the activity of a protein found on the surface of cells that~     may control tumor growth and survival. This may stop further spread of tumor cells.~      Mefloquine is designed to block a protein that helps to clean the waste in the cells and to~     destabilize the cell membrane. Blocking this protein may cause tumor cell death.~      Metformin is designed to block a protein in tumor cells that is important in tumor growth and~     blood vessel development. This may cause cell death or reduce the spread of the disease.~   "
163149|NCT01430338|"~     Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and~     especially during acute cold exposure. It is conceivable that BAT activity might reduce the~     risk of developing obesity since fat stores are used for thermogenesis, and a directed~     enhancement of adipocyte metabolism might have value in weight reduction. So it is important~     to know the different metabolic characteristics in human adults who have detected BAT.~     Therefore, the purpose of the investigators study is to compare different metabolic~     characteristics in the presence of brown adipose tissue in humans.~   "
163150|NCT01430325|"~     SCUBA divers and chamber inside attendants will undergo a brief hyperbaric chamber excursion~     and will be asked to what chamber pressure they were compressed and what gas they breathed.~   "
163151|NCT01430312|"~     The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam~     formulation.~   "
163152|NCT01430299|"~     The objective of this study is to prospectively evaluate the performance of Integra Accell~     Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a~     retrospective comparison to a historical patient cohort.~   "
163153|NCT01430286|"~     The aim of the project is to evaluate the efficacy of a web-based psycho-educational~     programme designed to support informal caregivers of patients with Alzheimer's disease~     (AD).This program focuses on information about the illness, her progression, how to prevent~     psychological strain using anticipation and relaxation techniques and providing a virtual~     space (forum) to discuss with other caregivers.~   "
163154|NCT01430273|"~     Main Objective: The purpose of this study is to demonstrate whether there is a correlation~     between perioperative blood loss and the degree of platelet inhibition assessed by a point of~     care assay in patients undergoing hip or knee arthroplasty and treated by antiplatelet~     mono/bi-therapy~   "
163155|NCT01430260|"~     This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in~     combination.~   "
163156|NCT01430247|"~     INTRODUCTION. Amblyopia is defined as the loss of visual acuity (VA) in one or both eyes,~     without any obvious structural or pathological anomalies. Amblyopic eye should be able to~     regain some VA if treatment is initiated before the age of seven. It is the leading cause of~     monocular blindness in the 20- to 70-year olds with prevalence 2-5%. Amblyopia is mainly~     monocular, hence children are general asymptomatic. VA testing is the only reliable method of~     detecting amblyopia, and the fourth year of life is considered best for vision screening~     programs.~      AIM: The purpose of the study is to reduce the preventable vision loss. The main goal of the~     study is to evidence the problem of amblyopia in Zagreb and to release a model for formal,~     government directed vision-screening program as a Croatian public health policy.~      HYPOTHESIS. In Croatia, the prevalence and actual effect of amblyopia and amblyogenic~     factors, along with treatment efficacy is impossible to quantify, since no population-based~     studies have been performed regarding this issue. In addition, national screening of~     preschool children does not exist, while the school-entry screening is prescribed by law. The~     object of the study is to determine the prevalence of amblyopia in a 4-4.5 year old children~     of The Town of Zagreb, the efficacy of screening and effectiveness of treatment on reducing~     amblyopia prevalence. The primary hypothesis is defined: screening of visual acuity~     monocularly at distance and near in 4-4.5 year old children in Zagreb is effective in~     detecting amblyopia.~      PATIENTS AND METHODS: Monocular vision of about 7000 children/ year aged 4-4.5 for whom both~     parents gave consent is to be tested with Lea chart at near (40cm) and distance (3m) in the~     kindergartens of The Town of Zagreb. The criterion for referral to complete ophthalmological~     examination is VA <0.8.~   "
163157|NCT01430234|"~     Treatment of exocrine insufficiency (EPI) consists of pancreatic enzyme replacement according~     to the fat intake. Prescribing a sufficient dose of pancreatic enzymes is mandatory for the~     treatment to be effective. In addition, consultation of a specialized dietician is pivotal to~     educate patients about the proper use of pancreatic enzymes. However, based on a recent~     prospective survey in the Netherlands amongst chronic pancreatitis patients, it seems that~     enzymes are underused and a dietician is seldom consulted. The aim of this study is to assess~     if there is a difference in efficacy of pancreatic enzymes in a self-dosage regimen after~     extensive patient-education in comparison to the standard treatment for patients with EPI.~   "
163158|NCT01430221|"~     The purpose of this study is to compare the effectiveness of educational and lifestyle~     intervention programs aimed at reducing fasting blood sugar and emotional distress in adults~     with prediabetes.~   "
163159|NCT01430208|"~     Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine~     diseases. The development of smaller hysteroscopes allowed to change the approach to the~     intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al.~     developed a mini-resectoscope feasible for see&treat hysteroscopy. The objective of the~     study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr~     resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions.~     The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas,~     randomly allocated to receive the treatment with traditional resectoscope (127 women), with~     mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating~     time, distension media delivered, dismiss time and discomfort experienced were recorded.~   "
163160|NCT01430195|"~     The purpose of this study is to look at the efficacy of afamelanotide, when combined with~     narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo.~     Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to~     reducing frequency and doses of NB-UVB.~   "
163206|NCT01429584|"~     Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the~     neck, in the interscalene area, provide pain relief after shoulder surgery but can cause~     temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower~     concentration of bupivacaine would cause less weakness of the diaphragm but still provide~     good pain relief. Lung function and pain control was studied after interscalene peripheral~     nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.~   "
163162|NCT01430169|"~     This study is a Phase 2, open-label study to assess the pharmacokinetics (PK) and safety of~     AA4500 0.58 mg in men with Peyronie's disease. Subjects will be screened for study~     eligibility within 21 days before the initial injection of study drug. Two injections will be~     administered 24 hours apart.~      Subjects will be admitted to the study unit the day before the first injection of AA4500 (Day~     -1) and will remain in the study unit until after the PK sample is collected after~     investigator penile plaque modeling on Day 3. Subjects will return to the study unit on Day~     4, Day 8, and Day 29 for follow-up pharmacokinetic and safety assessments.Pharmacokinetic~     plasma samples will be collected at predetermined time points before (15 minutes~     pre-injection) and after each injection on Day 1 and Day 2 (5,10, 20, 30 minutes and~     1,2,3,4,8,12 hours after), and on Days 3, 4, 8, and 29.Plasma levels for AUX-I (clostridial~     type I collagenase) and AUX-II (clostridial type II collagenase) will be determined.~   "
163163|NCT01430156|"~     This is a blinded, placebo-controlled, randomised controlled trial looking at the effects of~     Heme arginate (HA) on cadaveric renal transplantation. The investigators know that HA can~     upregulate HO-1, which has been shown to have a protective effect on animal transplants.~      The investigators will be giving HA/placebo to participants prior to transplant and repeat~     again on day 2 post-transplant and compare outcomes.~   "
163164|NCT01430143|"~     The aim of the study is to 1) delineate the molecular mechanisms behind the large variation~     in insulin sensitivity among apparently healthy subjects and to 2) establish the~     dose-response relationship between physical training and a) metabolic health, b) appetite and~     c) cultural health.~   "
163165|NCT01430130|"~     Neodyne has developed an investigational dressing for post-operative incision care. Neodyne~     is conducting this research to study whether the investigational dressing, called the Neodyne~     Dressing, can minimize scar formation in a simple manner.~   "
163166|NCT01430117|"~     The objective of this study is to determine the biologic activity of a Poa pratensis allergen~     extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference~     preparation (IHRP).~   "
163167|NCT01430104|"~     The purpose of this trial is to assess the effects on serum calcium when teriparatide is used~     with active vitamin D in osteoporosis patients.~      This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment~     Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium~     supplementation from the Lead-in Period throughout the study. During the Treatment Period,~     daily administration of teriparatide will be added.~   "
163168|NCT01430091|"~     This study compares the clinical tablet formulation of prasugrel taken orally with an orally~     disintegrating tablet (ODT) taken orally. The study will evaluate the amount of prasugrel~     active metabolite circulating in the blood for each treatment.~   "
163169|NCT01430078|"~     The objective of the study is to assess the bioavailability of ASP015K within the~     gastrointestinal tract.~   "
163170|NCT01430065|"~     This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy~     volunteers.~   "
163171|NCT01430052|"~     The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1~     combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable~     locally advanced pancreatic cancer.~   "
163172|NCT01430039|"~     Syndecan-1 is a protein on the surface intestinal cells. previous studies proved low levels~     of mucosal syndecan-1 levels on the surface of intestinal cells is patients with acute and~     chronic inflammation due to inflammatory bowel disease.~      this protein might shed from cell surface to the serum. The investigators wish to prove that~     elevated serum levels of syndecan-1 may be predictive of disease presence, extent and~     severity, that buy taking a simple blood sample from patients diagnosed with inflammatory~     bowel disease and comparing to normal subjects and to other markers.~   "
163173|NCT01430026|"~     The propose of this study to determine efficacy and complication of gentamicin nasal~     irrigation in chronic rhinosinusitis~   "
163174|NCT01430013|"~     To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T~     cell lymphoma.~   "
163175|NCT01430000|"~     Patients who completed the conventional treatment against HCV and relapsed (the virus~     appeared again in their blood) have no effective therapy.~   "
163176|NCT01429987|"~     This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose~     ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to~     placebo in patients with Chronic Idiopathic Constipation (CIC).~   "
163177|NCT01429974|"~     Meconium constitutes the bowel contents of the fetus and is normally expelled only after~     birth. However, it may be secreted into the amniotic fluid of 20% of all fetuses. Meconium~     Stained Amniotic Fluid had been recognized from ancient times as an obstetric hazard which~     complicates delivery and is associated with increased newborn morbidity and mortality. At~     present there is no viable diagnostic test for Meconium prior to the onset of labor and the~     rupture of membranes. The system developed for the detection of Meconium, based on~     recognizing a characteristic fluoroscopic spectral pattern emitted by Meconium under light~     excitation at a specific wavelength. The diagnostic test being developed does not require~     penetration into the amniotic sac and is safe, painless and simple to perform.~   "
163178|NCT01429961|"~     Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with~     Advanced Hepatocellular Carcinoma~   "
163179|NCT01429948|"~     We hypothesized that paradoxical embolism may be one of the main mechanisms of silent~     cerebral infarction (SCI) located outside the perforating artery territory. In the present~     study, we evaluated the association between SCI and paradoxical embolism detected by agitated~     saline transcranial Doppler (TCD) monitoring in healthy subjects without history of stroke or~     transient ischemic attack (TIA). We also compared the frequency and amount of paradoxical~     embolism between healthy subjects with SCI and acute stroke patients with presumed~     cryptogenic embolism or conventional stroke mechanisms.~   "
163207|NCT01429571|"~     Three patient groups with simple hand infections are tested regarding the necessity of~     antibiotics after surgical treatment.~   "
163316|NCT01428141|"~     The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK),~     pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to~     patients with advanced solid tumor and gastric cancer.~   "
163180|NCT01429935|"~     Ginger contains constituents with pharmacological properties similar to the novel class of~     dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the~     cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer~     side effects than conventional NSAIDs and now are being investigated as a novel class of~     anti-inflammatory compounds. Although ginger has potentially strong anti-inflammatory~     components, its efficacy on acute inflammation was not assessed before. The common~     postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling,~     related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a~     crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental~     pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy~     of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several~     clinical trials. However, NSAIDs are contraindicated in patients with gastrointestinal~     ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an~     effective, oral analgesic with a more favorable safety profile. The primary aim of this study~     was to investigate the ability of Ginger powder (Zintoma, Goldaru) to reduce postoperative~     swelling, pain and trismus in an acute pain model.~   "
163181|NCT01429909|"~     Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing~     neuronal activations during motor or cognitive tasks. The MRI sequences used are currently~     optimized for the study of cortex activations, particularly concerning the echo time~     (TE).Very few studies are interested in optimizing the fMRI for the study of the basal~     ganglia, structure implicated in many neurological diseases such as Parkinson's disease. The~     T2 * is a tissue parameter dependent of iron content, which differs with brain structures and~     probably also with age and in case of neurodegenerative disease. Optimal TE s should~     correspond to the T2 * of studied brain structure The primary purpose is to optimize the fMRI~     by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The~     secondary purpose is to study the effect of age and Parkinson's disease on T2*.~   "
163182|NCT01429896|"~     Food allergy is a common problem, affecting 5-8% of the population. Peanut allergy causes~     reduced quality of life due to the perceived high risk of severe reactions. Patients rely on~     accurate labeling of both loose and pre-packed foods, but these are often ambiguous and~     unhelpful. There is a common conception that labeling is 'over-cautious'. Peanut-allergic~     consumers face increasingly restricted food choices in complying with this advice due, in~     part, to the proliferation of advisory labels such as 'may contain peanuts'. This contributes~     to the reduces quality of life of affected individuals.~      For industry to provide more accurate and helpful labeling, certain characteristics of the~     food-allergic population need to be defined. Firstly, the minimum 'eliciting dose' for the~     population has been estimated by studying large groups of peanut allergic patients who are~     challenged with peanut ingestion in increasing amounts. From these, an eliciting dose that~     provokes a reaction in 10% of the food-allergic population has been estimated at between six~     and 14mg of peanut protein.~      Translation of population eliciting doses (ED) into acceptable levels of allergen~     contamination for the population requires consideration of a 'safety factor'- to account for~     individual variability in dose threshold and severity. Data suggest such variability depends~     in part on extrinsic factors (exercise and sleep restriction). Each factor may have a~     different effect in scale and direction. The investigators are proposing a cross-over trial~     with 85 peanut-allergic adults who will each undergoing a baseline peanut challenge followed~     by repeat challenges with extrinsic factors applied, in random order (repeat baseline,~     +exercise and +sleep restriction). These data will further define ED for the UK population~     and a safety factor derived from shift in threshold, to inform industry and protect the~     allergic population.~   "
163183|NCT01429883|"~     Patients with Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea~     or Epikondylopathia humeri /radii get the shock wave therapy in our clinic as planned. During~     our study the investigators want to ask for pain, pain reduction and function.~   "
163184|NCT01429870|"~     Objective(s):~      (i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb~     and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50%~     loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent~     treatment.~      (ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb~     and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).~        -  Trial with medicinal product~   "
163185|NCT01429857|"~     The purpose of this study is to investigate the prognostic value of admission~     high-sensitivity troponin in patients with acute decompensated heart failure.~   "
163186|NCT01429844|"~     The purpose of the study is to compare efficacy and safety of two different immunosuppressive~     regimens for prevention of bronchiolitis obliterans syndrome (BOS) (chronic lung allograft~     rejection)after lung transplantation: tacrolimus versus cyclosporine, both in combination~     with mycophenolate mofetil and steroids. The study was powered to detect a 15% reduction in~     BOS in tacrolimus treated patients.~      Study design: open-label, randomized, comparative, multi-center, investigator driven~   "
163187|NCT01429831|"~     The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in~     outpatients with major depressive disorder who have had inadequate response to~     antidepressants in Taiwan clinical practice.~   "
163188|NCT01429818|"~     The Purpose of this study was to evaluate the effect of the combination glimepiride/metformin~     over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM)~     using 13N-ammonia-positron emission tomography (PET).~   "
163189|NCT01429805|"~     The purpose of this study is to obtain information on the safety and performance of HipJack~     Balloon Spacer to access the central compartment of the hip and maintain intra-articular hip~     joint distraction during arthroscopy of the central compartment of the hip.~   "
163190|NCT01429792|"~     This multi-center study will evaluate the viral response in patients with chronic hepatitis~     C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a)~     and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral~     Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as~     slow responders/non-rapid virological responders will be eligible for an additional 24 weeks~     of treatment.~   "
163191|NCT01429779|"~     The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal~     passage through the preoperative use of Movicol.~      Hypothesis The use of Movicol® during one week prior to partial liver resection combined with~     the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional recovery by~     promoting early return of gastro-intestinal function, defined as the passage of stools and~     early oral intake.~   "
163325|NCT01428024|"~     The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip~     products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the~     injection technique.~   "
163192|NCT01429766|"~     100 suitable patients of lung cancer shall be taken into the study over a period of 2 years.~     As per the existing treatment protocol in our department, all patients suitable shall undergo~     a routine Pulmonary function testing (PFT). Subsequently, recording of the breath hold shall~     be done at the following times~        1. At time of simulation~        2. At the time of first fraction of radiotherapy~        3. At mid radiotherapy~        4. At radiotherapy conclusion After the recording at a), patients shall be asked to perform~          deep breathing exercises/spirometer ball exercise to see the effect of training on the~          breath holding times.~   "
163193|NCT01429753|"~     Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in~     patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to~     improve LV function in patients with heart failure if those regions of the myocardium which~     are most compromised by electromechanical dyssynchrony can be identified and effectively~     stimulated. There still remains, however, a significant rate of up to 30% of patients who do~     not respond to treatment. Reasons for lack of benefit can be related to the inability of~     identifying and effectively stimulating those regions of myocardium, which are most~     compromised by electromechanical dyssynchrony. The investigators hypothesize that by using~     cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine~     the site of latest LV activation, the investigators can find the best place to implant the~     left ventricular lead. By avoiding scar and pacing in the site of latest activation, the~     investigators believe the investigators will reduce dyssynchrony and thus improve overall~     heart function. The researchers thus aim to increase the proportion of people who respond to~     treatment. The researchers also believe that the procedure may be streamlined so as to reduce~     procedure duration, radiation dose and dose of iodinated contrast medium.~   "
163194|NCT01429740|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of~     14 days of treatment with PF-05180999 in healthy subjects.~   "
163195|NCT01429727|"~     The primary goal of this project is to describe the clinical and physiologic characteristics~     of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness,~     understanding, treatment and prevention of a potentially fatal cardiovascular event.~      This study will be a retrospective and prospective review of medical course and current~     health of men and women with SCAD.~      A prospective sub-study of echocardiographic findings after SCAD that includes perfusion~     imaging (Lumason contrast) is available to patients who are evaluated at Mayo Clinic,~     Rochester, MN. A separate consent process is included as part of this sub-study.~   "
163196|NCT01429714|"~     In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis~     (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic~     syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years.~     It is however unclear whether all patients benefit to the same extent from this therapy or~     what the optimal duration of ECS therapy for individual patients should be. ECS therapy is~     not only costly, inconvenient and demanding but sometimes also even debilitating. Substantial~     costs could be saved by tailoring therapy to individual needs and as a result the quality of~     life for individual patients can be expected to improve.~      This study aims to assess the costs and effects of tailoring the duration of ECS therapy~     after DVT to individual patients needs.~      ECS therapy with a standard duration of 24 months will be compared with tailored ECS therapy,~     following an initial therapeutic period of 6 months, in patients with acute proximal DVT. The~     primary outcome is the percentage of patients with PTS at two year follow-up.~      This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.~   "
163197|NCT01429701|"~     Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity~     and impaired quality of life due specially pruritus and physical visible skin lesions. The~     purpose of this trial is evaluate the effectiveness of two different topic associations of~     drugs.~   "
163198|NCT01429688|"~     The purpose of this study is compare the safety and pharmacokinetic characteristics of~     DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after~     multiple oral administration in healthy male volunteers.~   "
163199|NCT01429675|"~     The purpose of this study is compare the pharmacokinetic characteristics of DP-R206 (150mg~     Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Bonviva (150mg Ibandronate, qd)~     after oral administration in healthy adult volunteers.~   "
163200|NCT01429662|"~     The purpose of this study is to demonstrate better effectiveness of modified relaxation (MR)~     technique over no MR for treating hypertension in Thai postmenopausal women.~   "
163201|NCT01429649|"~     With the advent of CT screening for lung cancer, there is an increase in the detection of~     pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass~     opacities can be caused by normal expiration, partial filling of air spaces, partial collapse~     of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic~     proliferation of neoplasm. Precise details of the natural history of focal pure GGO are still~     largely unclear. A number of differential diagnoses are possible, including inflammatory~     disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma in situ. Some~     of pGGOs remained stable over a considerable time. A long doubling time for pGGOs is already~     known. Therefore, the strategy of treatment for focal pure GGO lesions is still undecided.~     The major issue is whether or not the doctors should treat these patients at all or wait~     until the first sign of a solid lesion developes which may take many years.~      The purpose of this study is to determine if the ablation therapy is safe and effective for~     the pulmonary pGGO.~   "
163202|NCT01429636|"~     The purpose of this study is to demonstrate better efficacy and effectiveness of modified~     applied relaxation technique over its original version for treating menopausal symptoms.~   "
163203|NCT01429623|"~     The purpose of this study is to determine whether treatment with the investigational drug~     ladostigil will delay the onset of Alzheimer's disease(AD) in patients with Mild Cognitive~     Impairment (MCI). MCI is now recognized as a precursor to AD and clinical tools are available~     to assess cognitive performance at this earlier stage. Ladostigil is currently under~     investigation for the treatment of AD. In this study, the investigators will be examining~     ladostigil at a lower dose level. At this dose level, ladostigil has been shown to reduce~     signs of early memory loss in animals. Thus, in this study the investigators are attempting~     to determine if earlier invention with a lower dose of ladostigil will significantly reduce~     initial memory loss and delay the subsequent progression to more serious cognitive~     dysfunction.~   "
163208|NCT01429558|"~     The purpose of this project is to study live recordings from neuronal population of the human~     nucleus accumbens during the implantation of deep brain stimulation (DBS) electrodes for the~     treatment-resistant obsessive compulsive disorder (OCD). The central aim of this project is~     to determine if intra-operative electrophysiological data can confirm that the electrode is~     located in the nucleus accumbens. This confirmation could allow the placement of the DBS~     electrodes with a higher degree of precision. An additional aim of this project will be to~     study the activity of the neuronal population of the nucleus accumbens while a subject is~     presented with a task involving an unexpected reward.~      The investigators central hypothesis is that unexpected reward will be associated with~     increase firing and synchrony in the neuronal population. This will translate into recordable~     increase activity in the investigators region of interest and therefore confirm the proper~     placement of the electrode.~      This study enrolled 2 subjects, with 1 subject completing the protocol showing the~     feasibility of the experiment. There were electrophysiological variations with the task~     presented but no conclusion could be drawn given the small sample size.~   "
163209|NCT01429545|"~     The purpose of this study is to compare the tocolytic efficacy, effectiveness and safety of~     Atosiban in comparison with the combination of Atosiban and Nifedipine together.~   "
163210|NCT01429532|"~     The purpose of this study is to compare the outcomes of cataract surgery performed with three~     incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).~   "
163211|NCT01429519|"~     The study objectives are to evaluate safety and efficacy of topical administration of RPh201~     oil solution (botanical extract) for treatment of patients with hard to heal chronic~     ulcerated wounds.~   "
163212|NCT01429506|"~     In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy~     with intensive medical management on weight and metabolic parameters.~   "
163213|NCT01429493|"~     In various common cancers, the skeleton is a preferred site of metastasis. These bone~     metastases are the most common cause of cancer-related pain, which significantly impair~     quality of life. It is postulated that the clinical target volume (CTV) of painful bone~     metastases consists of cancer cells and tumor-associated host cells: the tumor-host~     ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us~     to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone~     metastasis. These findings suggest the potential of intentionally non-homogenous dose~     escalation (dose painting by numbers) to improve pain control. The hypothesis is that~     fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone~     metastasis regions confined with tumor-associated host-cell compartments responsible for~     metastasis-related pain. The primary objective is to improve pain control with biological~     image-guided stereotactic body radiotherapy compared to conventional radiotherapy.~   "
163214|NCT01429480|"~     TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method~     after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest~     methods of analgesia. The researchers wish to investigate whether the TAP block is as~     effective as the ilioinguinal/iliohypogastric nerve block?~   "
163215|NCT01429467|"~     The aim of the study is to see how glycaemic control and glycaemic variability affect levels~     of HIF, VEGF, erythropoietin and cortisol in Paediatric Type 1 diabetics on insulin pump~     therapy.~   "
163216|NCT01429454|"~     The overall goal of the present study is to determine whether Omega-3 Fatty Acids potentially~     prevent onset of psychosis and improve clinical symptoms and functional outcome in youth and~     young adults at elevated clinical risk for schizophrenia and related disorders. The specific~     aims are: (1) To determine whether the rate of progression to psychosis is lower during six~     months of treatment with Omega-3 Fatty Acids compared to six months of treatment with~     placebo, (2) To determine whether Omega-3 Fatty Acids are more efficacious than placebo for~     prodromal symptoms, negative symptoms, and functioning, (3) To assess the safety and~     tolerability of Omega-3 Fatty Acids in this population, and (4) To conduct analyses of~     neuroimaging, neurocognitive, electrophysiological and other ancillary data to explore~     mechanistic explanations for the hypothesized benefits of Omega-3 Fatty Acids on clinical and~     functional outcomes (e.g., increases in white matter integrity and processing speed).~   "
163217|NCT01429441|"~     The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion~     / (VMT) including macular hole with ocriplasmin.~   "
163218|NCT01429428|"~     This is a randomized and controlled study to investigate if the far-IR radiation emitted by~     compression stockings fabric may be effective and safe as adjuvant treatment for cellulitis~     that affects the majority of women after puberty.~      The investigators expect that the far-IR effects on superficial microcirculation,deep dermis~     and subcutaneous fat may attenuate the clinical aspect of cellulitis.~   "
163219|NCT01429415|"~     Acute asthma is the most common cause of pediatric hospitalizations. While the investigators~     know that repeat inhalations of ß2 agonists and ipratropium with early oral steroids~     substantially reduce hospitalizations, many children are resistant to this standard initial~     therapy. About a third of children remaining in moderate to severe distress after standard~     therapy are admitted to hospital and comprise 84% of pediatric acute asthma hospitalizations.~     Finding safe, non-invasive, and effective strategies to treat children resistant to standard~     therapy would substantially decrease hospitalizations resulting in considerable health care~     savings and reduction of the psycho-social burden of the disease. While studies of magnesium~     sulfate (Mg) given intravenously (IV) suggest that this agent can reduce hospitalizations in~     both adults and children resistant to standard initial therapy Nebulization is an alternate~     route for administering Mg. This route has the advantage of being non-invasive and is likely~     much safer due to lower systemic delivery. Direct delivery via nebulization allows higher Mg~     concentrations at the target site, the lower airways, with a smaller total drug dose. The~     investigators propose to conduct a properly designed study to clarify the role of nebulized~     Mg.~   "
163233|NCT01429233|"~     This is a Phase 4, observational, open study in patients whom their doctor for clinical~     practice prescribes levamlodipine. No medication was provided by the sponsor. The planned~     observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline~     followed by information gathered from the assessment visits at week 4 and week 8, or clinical~     practice.~   "
163220|NCT01429402|"~     Botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif) is widely used for facial~     rejuvenation and many other medical indications. It induces chemodenervation through its~     action on the presynaptic neuron, preventing release of acetylcholine, which leads to~     functional denervation of striated muscle for 2 to 6 months after injection. The use of~     botulinum toxin injection to reduce the facial scar is logical because this could reduce the~     tensile distracting force of the upper lip caused by the orbicularis oris muscle pull.~     Tollefson has demonstrate that botulinum toxin injection has decrease lip tension after~     primary lip repair in 3 children at 3-6 months of age The main aim of this randomized trial~     is to compare whether post-operative peri-surgical-injection of botulinum toxin into~     bilateral orbicularis oris muscles can improve scar formation for both primary and secondary~     cleft lip surgery.~   "
163221|NCT01429389|"~     The specimen collection is designed for the purpose of the development of a noninvasive~     prenatal test for T21.~   "
163222|NCT01429376|"~     The aim of the present study is:~        1. To investigate pulmonary function abnormalities (restriction, obstruction, diffusion~          impairment, mixed pulmonary defects) in patients with chronic heart failure (CHF) and to~          determine which of these pulmonary abnormalities prevail and to what extent.~        2. To determine the prevalence, underdiagnosis, and overdiagnosis of chronic obstructive~          pulmonary disease (COPD) as determined by spirometry and according to Global Initiative~          for Chronic Obstructive Lung Disease (GOLD) criteria in patients with CHF.~        3. To investigate the presence of systemic inflammation, as measured by inflammatory~          parameters (leukocytes, platelets, high sensitivity CRP), in CHF patients with or~          without COPD.~   "
163223|NCT01429363|"~     The prospective Clinical Series (CS) aims to prove the hypothesis that Targeted Disc~     Decompression (TDD) reduces the pain in patients suffering from radicular leg pain secondary~     to a contained focal disc protrusion (Lumboradicular Syndrome). Secondary objective will be~     to prove that the treatment Group will have less disability and better quality of life.~   "
163224|NCT01429350|"~     The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as~     an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator~     (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV~     rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not~     work very well in cases where the stroke is caused by a large vessel occlusion. The~     hypothesis being tested is to determine if the addition of a treatment by a mechanical~     thrombectomy device like the Penumbra System can improve the clinical outcome of the patient~     over just using IV rtPA alone.~   "
163225|NCT01429337|"~     The purpose of this international study is to assess the effect of varying degrees of~     impaired hepatic function compared to a normal hepatic function (Child-Pugh classification)~     on the pharmacokinetics and safety of midostaurin.~   "
163226|NCT01429324|"~     This study is designed to assess the feasibility of evaluating cerebral saturation during~     critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral~     Perfusion.~   "
163227|NCT01429311|"~     Atopic dermatitis (AD) is a chronic skin disorder characterized by recurrent viral skin~     infections. A small subset of patients with AD suffer from disseminated viral infections,~     e.g., eczema herpeticum (ADEH+), after herpes simplex infection (HSV) or eczema vaccinatum~     (EV) after smallpox vaccination. Interferon gamma (IFNγ) plays a critical role in the innate~     and acquired immune responses by activating macrophages, enhancing natural killer cell~     activation, and promoting T cell differentiation, as well as regulating B cell isotype~     switching to immunoglobulin (Ig) G2a. Recent studies have demonstrated that IFNγ generation~     was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is~     to determine if deficient IFNγ induction leads to susceptibility to HSV infection in ADEH+~     patients.~   "
163228|NCT01429298|"~     In this randomized controlled trial, 2 mg intravenous (IV) hydromorphone will be more~     efficacious than usual care (usual care is analgesic management according to the judgment of~     the attending physician caring for that patient) in emergency department (ED) patients aged~     21-64 years. The primary efficacy outcomes are the proportion of patients in each arm who~     choose to forgo additional pain medication in 30 minutes of entry into the study and the~     change in numerical rating scale (NRS) pain scores from baseline to 30 minutes post baseline.~   "
163229|NCT01429285|"~     The hydromorphone protocol is more effective than usual care in Emergency Department (ED)~     patients age 65 years and older in terms of proportion who choose to forgo additional pain~     medication within 60 minutes post-baseline in the two groups.~   "
163230|NCT01429272|"~     The purpose of this study is to determine whether minocycline and aspirin are effective in~     the treatment of depression in individuals with bipolar disorder.~   "
163231|NCT01429259|"~     This study will determine the concentrations of the antibiotic meropenem when administered as~     a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an~     acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour~     infusion will be measured.~   "
163232|NCT01429246|"~     The study was a single-blind randomized controlled trial conducted between February and~     August 2009 in two townships (Yangbajing and Gongtang) of Dangxiong County, an area at 4300~     meters altitude in Tibet. A brief baseline survey and assessment for eligibility was~     performed before randomization. A total of 282 residents with known hypertension (systolic~     blood pressure ≥ 140mmHg) were recruited and randomly assigned to intervention or control~     with stratification by gender and baseline blood pressure. The intervention group received~     6-month's supply of salt substitute (68% sodium chloride, 22% potassium chloride and 10%~     magnesium sulfate heptahydrate) and the control group 6-month's supply of regular salt (100%~     sodium chloride). After 3-month's intervention, the ones with a blood pressure above 140 mmHg~     / 90 mmHg will be given low-dose diuretic for further anti-hypertensive therapy. The study~     hypothesis is that salt-substitute will greatly reduce blood pressure in treated patients~     when compared to controls. Blood pressure levels were measured at baseline and followed up by~     trained observers using an automated sphygmomanometer and brief survey on level of~     compliance, amount of salt consumed, and reasons for non-compliance.~   "
163234|NCT01429220|"~     The purpose of this study is to evaluate the utility of a portable motion sensor-based system~     designed to assist with deep brain stimulation (DBS) programming sessions for Parkinson's~     disease patients.~   "
163236|NCT01429194|"~     The Articulating Circular Endoscopic (ACE) Stapler is an investigational system using~     endoscopic guidance to trans-orally place plications in the stomach in obese subjects to~     reduce volume and expansion of the fundus and greater curve to abate hunger as part of a~     supervised weight reduction program.~      The primary objective of this study is to perform an evaluation of the safety of the~     plication procedure.~      The secondary objective of this study is to evaluate the preliminary efficacy of the ACE~     Stapler for the treatment of obesity over a 24 month follow-up period.~   "
163237|NCT01429181|"~     There is a growing evidence that the d-isomer of methadone is effective in treating~     neuropathic pain while the l-isomer of methadone is the only effective isomer of methadone~     for treating somatic pain. This study will examine a combination of different amounts of the~     d- and l-isomers of methadone specifically tailored to the chronic peripheral neuropathic~     pain. Non-racemic mixture of methadone isomers will be tested in this pilot efficacy and~     safety study.~      This study will evaluate effect of the three doses of the non-racemic mixture of methadone~     hydrochloride patients with chronic peripheral neuropathic pain compared with a placebo. The~     study will also examine the minimally effective and maximally tolerated doses of the~     non-racemic mixture of methadone. Finally, the safety and tolerability of the non-racemic~     methadone therapy will be evaluated.~   "
163238|NCT01429168|"~     This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in~     participants with osteoarthritis who are experiencing inadequate response to their current~     treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily. Those~     participants who experience a clinically meaningful response to etoricoxib 60 mg daily within~     two weeks will be eligible to enter the double-blind withdrawal period (Part II). Responders~     entering Part 2 will be randomized in a 1:1 ratio to receive either etoricoxib 60 mg or~     placebo.~   "
163239|NCT01429155|"~     Hepatitis C is the leading cause of liver transplants in the USA. Given that there is a~     national organ shortage, living donor liver transplantation has became a viable option for~     patients with end stage liver disease who are not severely ill. Recently particular~     polymorphisms of IL-28B gene were reported to correlate with histological recurrence and~     antiviral treatment response after orthotopic liver transplantation for hepatitis C. Similar~     results have not been described yet in living donor liver transplant patients.~      There is data suggesting slightly inferior outcomes in living donor liver transplants when~     done for hepatitis C. The investigators postulate that such inferior outcomes may be related~     to IL28 polymorphism concordance (i.e., unfavorable recipient polymorphism patients receive~     similarly unfavorable polymorphism livers from their relatives).~   "
163240|NCT01429142|"~     The objectives of the main study are to evaluate the effectiveness and the cost-effectiveness~     of a counseling intervention to support medication intake among patients treated for HIV. The~     aim is that through the availability of medication intake reports collected through~     electronic monitoring, more adherence problems can be identified and medical decision-making~     improves.~      A substudy focuses on the broader range of nursing care in HIV-treatment, examining the~     content of care delivered to support physical, mental, sexual and social well-being; whether~     the delivery of the AIMS intervention affects the quality of care on domains other than~     adherence; and whether the content of care on these various domains can be linked to patient~     well-being and satisfaction.~   "
163241|NCT01429129|"~     This study will examine the efficacy of mailed distribution of free Nicotine Replacement~     Therapy to smokers. Telephone numbers will be randomly selected from across Canada in order~     to recruit adult smokers interested in completing a smoking survey and willing to be~     interviewed again in 8 weeks and 6 months time. Study participants will be asked about their~     smoking history and a hypothetical question: would they be interested in receiving the~     nicotine patch if this were to be provided to them free of charge? Participants expressing~     interest will be randomly assigned to one of two groups. One group will be offered the~     opportunity to actually receive a program of 5 weeks of the nicotine patch for free right~     away and the other group will not be offered the free nicotine patches. The proportions of~     smokers in the two groups who quit smoking by the 6-month interview will be compared.~   "
163242|NCT01429116|"~     The purpose of this study is to evaluate the safety of tasimelteon in male and female~     patients who suffer from Non-24-Hour Sleep-Wake Disorder.~   "
163243|NCT01429103|"~     The purpose of this study is to determine if the menopausal transition is associated with~     subjective and objective cognitive declines that ameliorate in menopause. The investigators~     hypothesize that perimenopause is associated with both subjective memory complaints and~     objective declines in attentionally mediated cognitive tasks. The investigators also~     hypothesize that this is time-limited. The investigators predict that as women transition~     from early perimenopause to late perimenopause their performance on attentionally mediated~     and verbal memory tasks will decline, and that as they transition from late perimenopause to~     menopause, their performance will improve.~   "
163244|NCT01429090|"~     The primary objective of the study is:~      •To describe extent and rate of absorption of methantheline after single oral dose~     administration of Vagantin® coated tablets (Test) in comparison to a methantheline bromide~     solution (Reference)~      The secondary objectives of the study are:~        -  To determine elimination the half-life of methantheline bromide~        -  To describe the effects of Test and Reference on salivation, accommodation, pupil~          response, blood pressure and heart rate~        -  to assess frequency and intensity of adverse drug reactions~   "
163245|NCT01429077|"~     The purpose of this study is to evaluate the effectiveness of the medication levodopa, in~     combination with speech-language treatment, on the language outcome of study subjects with~     nonfluent aphasia (i.e. difficulty with the comprehension and expression of spoken and~     written language) following a stroke.~   "
163246|NCT01429064|"~     The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with~     castrate resistant prostate cancer.~   "
163247|NCT01429051|"~     The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of~     intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long~     term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.~   "
163326|NCT01428011|"~     The purpose of this study is to understand how communication between African American and~     white patients with high blood pressure and his/her primary care provider effects whether a~     patient decides to take their high blood pressure medications.~   "
163248|NCT01429038|"~     The immune system of a patient can attack the liver or the kidney received from a donor~     (organ rejection). This can be prevented by treating these patients long-life with~     immunosuppressive drugs. Unfortunately, these drugs lead to numerous side effects and fail to~     prevent the rejection occurring months later after the transplantation (chronic rejection).~     Recently, it has been shown that a particular type of cells present in the bone marrow,~     namely Mesenchymal Stem Cells (MSC), when injected to a patient, suppress its immune system~     and increase success rates of blood cells transplantation. This outcome opens doors to~     investigate the potential of these cells to provide a valuable tool for improving solid organ~     transplantation without the need of high concentration of immunosuppressive drugs. The~     present project aims at evaluating the safety and tolerability of MSC administration after~     liver or kidney transplantation.~   "
163249|NCT01429025|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.~     Others interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer~     cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by~     blocking blood flow to the cancer. Giving lenalidomide together with rituximab and~     bendamustine hydrochloride may kill more cancer cells.~      PURPOSE: This phase I trial studies the side effects and the best dose of giving lenalidomide~     together with rituximab and bendamustine hydrochloride in treating patients with refractory~     or relapsed indolent non-Hodgkin lymphoma.~   "
163250|NCT01429012|"~     Bone fractures heal most of the time particularly well and without complications. The~     solidification takes rarely more than two to three months. The wound healing depends greatly~     on a good blood supply and needs several steps. These processes culminate in a new mass of~     heterogeneous tissue which is known as the fracture callus. Unfortunately, 2%-5% bone~     fractures cannot achieve a proper solidification and between the ununited fragments a scar~     tissue appears. This incorrect healing induces pain and even infections. When this situation~     persists more than 6 months, it is referred to as nonunion fracture, which will require some~     form of intervention to stimulate the natural healing process of the body. First of all, good~     surgical techniques with stable immobilization should be applied and local infection should~     be excluded. Then stimulation of the callus is required. Cell therapy with bone marrow cells~     has emerged as a promising new approach for bone regeneration. Animal studies as well as~     preliminary human studies have shown that Mesenchymal Stem Cells, a particular kind of stem~     cells isolated from the bone marrow, could induce callus formation when injected in the~     nonunion site of a broken bone.~      In this study the investigators aim at determining whether Mesenchymal Stem Cells (MSC)~     isolated from the patient's bone marrow and injected in the nonunion site could be a safe and~     effective treatment for nonunion fractures. Patients will be randomized in two groups; one~     injected with Mesenchymal Stem Cell and the other injected with placebo. The investigators~     seek also to know how long it takes to develop the callus formation and whether there is a~     partial or a complete callus formation.~   "
163251|NCT01428999|"~     The purpose of this study is to evaluate the effect of combined probiotics to improve the~     gastrointestinal function and intestinal bacteria flora~   "
163252|NCT01428986|"~     This study is to investigate the safety of maraviroc by examining whether there is bone~     metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone~     mineral density and markers for bone formation, desorption and chemokine.~   "
163253|NCT01428973|"~     The present project is a multicenter phase II trail aiming at comparing which of the two~     postgrafting immunosuppressive regimens proposed in this study will be best suited to prevent~     graft-versus-host disease (GVDH).~      The immunosuppressive regimens will consist of: Tacrolimus plus Mycophenolate Mofetil or~     Tacrolimus plus Sirolimus. Before grafting patients will undergo a reduced-intensity~     conditioning with Fludarabine/total body irradiation (TBI) or~     Fludarabine/Busulfan/anti-thymoglobuline. Following the interim analysis of October 2014, the~     protocol has been amended to allow inclusion only after Flu-TBI conditioning. The hypothesis~     is that the Tacrolimus plus Sirolimus regimen will be associated with better progression-free~     survival due to a lower incidence of relapse/progression.~   "
163254|NCT01428960|"~     To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and~     inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic~     responses in healthy adult subjects.~      Study hypothesis: The degree of fat saturation does not affect postprandial lipemia,~     haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety~     responses in health adult subjects.~   "
163255|NCT01428947|"~     The purpose of the study is to study if coronary angiography cause cognitive dysfunction.~   "
163256|NCT01428934|"~     Cardiovascular risk functions fail to identify more than 50% of patients who develop~     cardiovascular disease. This is especially evident in the intermediate-risk patients in which~     clinical management becomes difficult. The purpose of this study is to analyze if~     ankle-brachial index (ABI), measures of arterial stiffness, postprandial glucose,~     glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are~     independently associated to incidence of vascular events and whether they can improve the~     predictive capacity of current risk equations in the intermediate-risk population.~   "
163264|NCT01428817|"~     Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the~     most common uterotonic drug used to prevent and treat PPH in North America, however, there~     are some limitations to its use. Oxytocin has a very short duration of action, which requires~     a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians~     and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of~     carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post~     partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts~     4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater~     efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin~     has not yet been published. The investigators hypothesize that the minimum effective dose~     (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.~   "
165269|NCT01402479|"~     Physiology of migraine involving renin-angiotensin systems (RAS) has been implicated.~     Ramipril is a broadly-used angiotensin-converting enzyme inhibitor. The investigators attempt~     to test the efficacy of ramipril on the prophylaxis of migraine attacks.~   "
163257|NCT01428921|"~     Obstructive sleep apnea (OSA) is a common sleep disorders associated with excessive daytime~     sleepiness and cardiovascular disease. Continuous positive airway pressure (CPAP) therapy is~     an effective standard treatment and is widely prescribed for patients with OSA. Successful~     CPAP treatment has also been shown to improve cognitive, cardiovascular and metabolic~     function. Sustainable CPAP treatment would alleviate the substantial cost burden of~     health-related consequences of untreated OSA.~      However, the use of CPAP for such patients is disappointingly low and limits the~     effectiveness of treatment. Early CPAP education and follow up have shown to be very~     important in helping subjects to handle side-effects or problems associated with the use of~     CPAP. Good education program at the initial phase of using CPAP is essentially affected the~     acceptance and adherence of CPAP therapy. Good CPAP adherence is not only medically essential~     to patients' health but also economically importance to society by alleviating the~     substantial cost burden of health-related consequences.~      To the best of our knowledge, there is no randomized clinical trial (RCT) to prove the~     long-term efficacy of extended education program on improving continuous positive airway~     pressure use and its treatment outcomes.~      The primary purpose of this study is to assess the long-term efficacy of our on-going RCT~     which is an extended education program on improving CPAP compliance.~      The investigators hypothesize that the application of both MI technique and SCT-based~     extended education program at the initial phase of using CPAP also would enhance CPAP~     adherence even after one year of attending education class.~   "
163258|NCT01428908|"~     Haemophilus influenzae is an important pathogen which can cause primary infection and~     respiratory viral infection in infants and leaded to secondary infections. The infection of~     haemophilus is a major cause of morbidity and mortality in infants and children. At present,~     the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine~     can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused~     by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal~     immune programming.~      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent~     years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus~     polysaccharide vaccine with a relatively poor immune response in the infants under the age of~     two, and the remaining 60% with a low antibody level and a short duration.~      According to the present immunization schedule, to reach the median level of antibody levels~     there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity,~     to provide high levels of long-term protection and to reduce the number of injections.~      After the phase I study which was conducted in August, 2011, the safety profile of this~     vaccine is proved to be acceptable. The phase III study is aimed to further evaluate the~     safety and the immunization of the vaccine. The objective of this study is to evaluate the~     safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal~     conjugate vaccine.~   "
163259|NCT01428895|"~     Bone is a common site of metastasis for a range of malignancies. Bone metastases have the~     potential to cause significant morbidity including pain, impairment of ambulation and reduced~     functional independence. Previous research has shown that pathological fractures are observed~     in 9 to 29 percent of patients with long bone metastases, and a high proportion of these~     require surgical intervention to relieve pain and restore function.~      The goal of this study is to describe the clinical outcomes of patients with femoral~     metastases at high risk of pathological fracture. Patients referred for treatment of femoral~     metastases at high risk of fracture will be followed prospectively after undergoing with~     surgery (± post-operative radiotherapy), or radiotherapy alone. Patient and disease~     characteristics, ambulatory status and limb function will be documented before treatment.~     These Clinical outcomes of participants in each treatment group will be measured 6 weeks~     after treatment, and 3- and 6 months after enrolment, with particular reference to~     patient-reported outcomes relating to pain, ambulatory status, limb function and quality of~     life.~   "
163260|NCT01428882|"~     Nonanesthesiologist administration of propofol for sedation is actually a field of growing~     interest for endoscopists, as demonstrated by recent American and European guidelines on this~     issue. Propofol is a hypnotic drug with rapid onset and offset of action. Used as a single~     agent, it is commonly titrated to deep sedation, whereas balanced propofol sedation (BPS),~     which combines propofol with small doses of a benzodiazepine and/or an opioid, can be~     successfully titrated to moderate sedation. However, nonanesthesiologists propofol~     administration remains controversial on account of the possibility of deep sedation/general~     anesthesia related adverse events. On the other hand, the use of longer elimination half-life~     drugs, such as opioids and benzodiazepines, may theoretically prolong sedation and recovery.~      Up to date, no study has addressed a head-to-head comparison of both regimens administered by~     non-anesthesiologists and titrated to moderate sedation.~      This study aims to evaluate the impact on propofol sedation of premedication with a fixed~     dose of midazolam (2 mg)2 minutes before propofol administration targeted to moderate~     sedation, in terms of depth of sedation, recovery times, safety and satisfaction.~      The onset of sedative action of midazolam has been reported to be 1-2.5 minutes and the peak~     effect of midazolam occurs 8-12 minutes. Taking into account that colonoscopy usually lasts a~     minimum of 15-20 minutes, our hypothesis is that synergy between propofol and midazolam may~     increase the depth of sedation through the initial phases of the procedure, diminishing~     propofol requirements, but not prolonging significantly recovery times.~   "
163261|NCT01428869|"~     The purpose of this study is to assess whether there is any interaction between statins,~     acetylsalicylic acid (ASA) and dutasteride on protection from prostate cancer, the~     development of high grade prostate cancer, or lower urinary tract symptoms.~   "
163262|NCT01428843|"~     Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This~     is due to iron deficiency and inflammation.~      Most of treatments aim to control inflammation using anti-TNF alpha therapy which should~     theorically reduce anemia.~      The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should~     reduce anemia and improve quality of life of patients.~   "
163263|NCT01428830|"~     This facility-based, multi-center randomized controlled trial (RCT) will test the~     non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14~     day) urethral catheterization in terms of predicting fistula repair breakdown three months~     following urinary fistula repair surgery. The study will be conducted among 507 women with~     simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.~   "
163266|NCT01428791|"~     Linkages between depression and cardiovascular disease have been well documented. These~     appear to be more than associations, and may reflect causal relationships through a number of~     proposed pathways, including decreased physical activity, poor dietary habits, medication~     non-adherence, and a direct impact on inflammatory mediators. Older adults are affected by~     both depression and heart disease, with increased risk in African American and Latino~     elderly.~      The BRIGHTEN-Heart trial tests the hypothesis that an enhanced primary care delivery system~     intervention which provides evidence-based, patient-centered mental health services targeting~     depression and cardiovascular risk factors can reduce the risk of development of~     cardiovascular disease in low-income elderly blacks and Hispanics. BRIGHTEN stands for~     Bridging Resources of a Geriatric Health Team via Electronic Networking, and in this~     intervention, specialty providers including geropsychologists, social workers, pharmacists,~     nutritionists, chaplains, occupational therapists, and others collaborate via the internet as~     a virtual team. The study will determine if such a virtual interdisciplinary clinical team~     collaboration can reduce depression in older (age ≥ 65) minority adults with comorbid~     depression and metabolic syndrome.~   "
163267|NCT01428778|"~     This prospective observational study will investigate the frequency of new onset atrial~     fibrillation (AF) and of further cardiac arrhythmias as well as of (clinically silent)~     cerebral lesions in endurance runners before, during and after the BMW-Berlin Marathon 2011.~   "
163268|NCT01428765|"~     This study constitutes Phase I of the Registry Program. The main objective of this study is~     to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and~     the selection of antithrombotic treatment for stroke prevention in a real-world setting~     before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in~     patients with non-valvular AF in different regions of the world.~   "
163269|NCT01428752|"~     Current guidelines for initiating screening colonoscopies in patients younger than 50 years~     of age who have a first relative history of colorectal cancer are controversial. The aim of~     this study was to prospectively define the prevalence of colorectal adenoma 30- to~     49-years-old asymptomatic subjects with a first relative history of colorectal cancer and to~     compare the data with controls.~      Design: Single-center prospective study~   "
163270|NCT01428739|"~     Correlation between MRS and Tumor Response Therapy in Breast Cancer.~   "
163271|NCT01428726|"~     The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of~     relapsing remitting multiple sclerosis, comparing two doses versus placebo.~   "
163272|NCT01428713|"~     Menorrhagia, considered a public health challenge and reported by 5 to 10% of adult women, is~     encountered even more frequently in adolescents. Surveys of school students in the United~     States (US) and Europe reported menorrhagia in 37% to 55% of adolescent females. Medical~     management of adolescent menorrhagia includes various formulations of hormonal therapy and~     the antifibrinolytic agent epsilon aminocaproic acid. Oral tranexamic acid (TA), a more~     potent antifibrinolytic agent used as standard therapy for menorrhagia in adult women and in~     adolescent women in Europe and Canada, was not previously available in the US. Subsequent to~     US FDA approval in November 2009 of a novel oral TA formulation to treat cyclic heavy~     menstrual bleeding in adult women, this medication is currently included in the treatment~     armamentarium for adult menorrhagia. There is currently no preliminary data available in the~     US about the clinical use of oral TA in an exclusive adolescent population with menorrhagia.~     Oral contraceptive pills (OCP) are considered standard therapy in the management of~     menorrhagia in teen-aged women. Oral TA has been shown to be more efficacious than~     progesterone-only hormonal therapy for menorrhagia in adult women. However, there is no data~     available comparing the efficacy of oral TA and combined OCP (COCP) in adult women or in~     adolescents with menorrhagia.~      The study hypothesis is that, in adolescent menorrhagia, oral TA will have comparable~     efficacy in reducing menstrual blood loss (MBL) and improving quality of life (QOL) when~     compared to the commonly prescribed COCP.~      This hypothesis was tested by comparing the efficacy of these two medications, in a~     prospective randomized crossover trial in post-menarchal young girls with menorrhagia.~   "
163273|NCT01428700|"~     Acute cellular rejection is relatively common after liver transplantation, typically does not~     affect graft survival, and is not associated with the development of chronic rejection. Acute~     cellular rejection is diagnosed when liver enzymes and/or liver function tests are elevated~     when compared to baseline. The only means of differentiating acute rejection from other liver~     pathologies is with a liver biopsy. However, even with this invasive diagnostic procedure, it~     may be difficult to distinguish acute rejection from another disease process, such as injury~     caused by the hepatitis C virus (HCV) from the native liver. This study will evaluate whether~     certain patterns of biomarkers in the peripheral blood and/or liver tissue of a liver~     transplant recipient can be used to determine if the transplanted liver is being rejected by~     the recipient or sustaining HCV injury. Diagnostic biomarkers that are specific for acute~     rejection and informative of the severity of HCV recurrence could allow for modulation of~     immunosuppression therapy and treat the clinical condition without the need for invasive~     liver biopsies.~   "
163274|NCT01428687|"~     A series of studies are proposed to develop an intervention to increase sleep duration and~     study the effects on eating, exercise, and weight control. The hypothesis is that increasing~     sleep duration will help improve weight loss and maintenance.~   "
163275|NCT01428674|"~     The purpose of this study is to describe the onset, duration and dose-response of~     interpersonal mindful compassion on respiratory rate and heart rate variability in healthy~     adults in order to prepare for research evaluating the impact of this intervention in patient~     populations and to prepare for basic research investigating the CNS mechanisms for observed~     effects.~      Previous research has found that mindfulness meditation, including mindful compassion,~     results in autonomic changes in the practitioner. Emerging neuroscience of dyadic~     interactions suggests that through the effects of mirror neuron isopraxis, one person's~     physiologic state may be mirrored by another. However, no research has directly evaluated the~     impact of one person's mindful compassion on another person's autonomic activity. This study~     paves the way for an entirely new avenue of research inquiry.~   "
163276|NCT01428661|"~     The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked~     treatment of tasimelteon or placebo in male and female subjects with Major Depressive~     Disorder.~   "
163277|NCT01428648|"~     Parkinson's disease (PD) affects ability of individuals to perform unconscious learned motor~     tasks, affects quality of life and has been associated with depression. The purpose of this~     study is to investigate the effect of dance therapy on motor performance, quality of life and~     depression in PD patients, by comparing certain symptoms between a group of subjects with PD~     who undergo ballroom dancing classes and a control group of subjects with PD. The~     investigators will assess mental status, severity of PD, quality of life and depression using~     rating scales. Subjects will be randomized to intervention and control group. Intervention~     group will participate in dance therapy for 12 weeks and will be examined at 12 and 20 weeks.~     Control group will be examined at same time intervals. Classes will follow a curriculum~     designed by Arthur Murray Dance Studio Staff. The investigators do not anticipate significant~     risk for participants.~   "
163278|NCT01428635|"~     The goal of this clinical research study is learn if eltrombopag can help control or prevent~     low platelet counts in patients receiving treatment for CML or myelofibrosis.~      This is an investigational study. Eltrombopag is FDA approved and commercially available for~     the treatment of patients with low platelet counts. The use of eltrombopag for the treatment~     of low platelet counts in patients with CML and myelofibrosis is investigational.~      Up to 39 patients will take part in this study. All will be enrolled at MD Anderson. As of~     June 6, 2017, the study is closed to new participants.~   "
163279|NCT01428622|"~     The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose~     combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic~     exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).~   "
163280|NCT01428609|"~     The aim of this study is to determine the blood's mercury level of patients who had amalgam~     root end filling surgeries. It is to be examined if the mercury concentration in blood is~     elevated by using amalgam retroseal.~   "
163281|NCT01428596|"~     This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The~     safety and immune responses will be studied in vaccine recipients. The anti-viral effect of~     HIVAX vaccine will be monitored during a 12-week treatment interruption phase.~   "
163282|NCT01428583|"~     The study will provide information to assess the benefits versus risks of extended exposure~     to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain~     population.~   "
163283|NCT01428570|"~     The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect~     laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal~     view and facilitated tracheal intubation in patients with restricted neck motion. The purpose~     of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when~     used by experienced anesthetists in Obstructive Sleep Apnea Syndrome (OSAS) patients and to~     compare its performance with the Macintosh laryngoscope.~   "
163284|NCT01428557|"~     The purpose of this study is to evaluate the demographic, clinical, prognostics~     characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart~     failure in a group of 60 hospitals representative in different regions.~   "
163285|NCT01428544|"~     The purpose of this post-marketing surveillance study is to collect and assess information~     retrospectively on safety and effectiveness of fondaparinux injection in patients with venous~     thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom~     fondaparinux was injected 10 mg/day.~      (Arixtra is a trademark of the GlaxoSmithKline group of companies.)~   "
163286|NCT01428531|"~     The purpose of this post-marketing surveillance study is to collect and assess information on~     safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).~      (Arixtra is a trademark of the GlaxoSmithKline group of companies.)~   "
163287|NCT01428518|"~     This post-marketing surveillance study is designed to collect and assess information on~     safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine~     clinical practice.~      (LAMICTAL is a trademark of the GlaxoSmithKline group of companies.)~   "
163288|NCT01428505|"~     This is a study aimed to characterize [18F]PBR111 as an in vivo marker of microglial~     activation in Multiple Sclerosis. Regional binding of [18F]PBR111 will be quantified with PET~     in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender-~     matched healthy volunteers.~   "
163289|NCT01428492|"~     Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with~     bortezomib and dexamethasone in multiple myeloma (MM) subjects who have failed at least one~     line of systemic treatment. Part 1 will identify the maximum tolerated dose(s) (MTD) of the~     combination regimen. Schedule A - GSK2110183 administered once daily with bortezomib (1.3~     mg/m2) and dexamethasone (20 mg) given biweekly. Part 2 will further explore the safety,~     tolerability and clinical activity of the MTD(s) identified in Part 1, including a~     pharmacokinetic cohort.~   "
163290|NCT01428479|"~     This study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete~     crossover, single and multiple dose study in healthy Japanese male subjects to assess the~     pharmacokinetics and safety/tolerability of single and multiple intravenous administration of~     GR121167. Serial blood samples and pooled urine samples for the determination of GR121167~     concentration will be collected and safety assessments will be performed for each treatment~     period.~      The pharmacokinetics and dose proportionality of GR121167 after single intravenous~     administration of GR121167 at the dose levels of 100 mg, 300 mg and 600 mg will be assessed.~     In addition, in the final treatment period (600 mg), twice daily intravenous administrations~     for 5 days will be also conducted and the pharmacokinetics and accumulation will be assessed.~   "
163291|NCT01428466|"~     This is a randomized, single-center, partial-blind study to evaluate the dermal irritation~     potential and to detect photo-toxicity and photo-allergy potential of GSK2585823, Benzoyl~     peroxide BPO 5% gel, Benzoyl peroxide 3% gel, vehicle gel and negative control (distilled~     water) applied using Finn-Chambers® by single and 7-day repeat patch test in 20 Japanese~     healthy male and female volunteers. Finn-Chambers containing no investigational product will~     be applied in the same manner.~      Safety will also be assessed by measurement of vital signs, electrocardiograms, safety~     laboratory data and review of adverse events.~   "
163292|NCT01428453|"~     The study is designed to investigate the effects of rilapladib on biomarkers related to the~     Alzheimer's disease, and cognitive function.~   "
163293|NCT01428440|"~     Apoptosis or programmed cell death is disrupted in cancer cells allowing them to live longer.~     A number of anti-cancer agents induce apoptosis as a mechanism of drug action to get rid of~     cancers. A biomarker that would allow apoptosis in tumours to be imaged directly would~     provide a powerful new tool for oncology drug development and potentially contribute to~     improved patient care. In this study, we propose to evaluate [18F]ML10-PET for imaging tumour~     apoptosis in patients receiving standard chemotherapy treatment for their cancer.~   "
163294|NCT01428427|"~     MEK112111 is a dose-escalation, Phase IB, open-label, single-arm, multi-center study. The~     primary objective of the study is to determine the recommended dose and regimen for the~     orally administered MEK inhibitor GSK1120212 dosed in combination with gemcitabine in~     subjects with solid tumors.~   "
163295|NCT01428414|"~     The purpose of the investigators study is to compare the efficacy and safety of combining~     trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant~     therapy in Chinese HER2-positive breast cancer patients. 100 patients from multicenter would~     be randomly assigned into two treatment arms and receive neoadjuvant chemotherapy followed by~     operation and adjuvant treatment. The main end point of this study would be the efficacy and~     safety of the two treatment arms, and the trend of the two curves is anticipated.~   "
163296|NCT01428401|"~     Astragalus membranaceus (AM) is used to treat stroke for a long period, and a number of~     studies have known that AM can reduce cerebral infarction area and has anti-oxidation.~     Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase~     intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present~     study was to investigate the effect of AM on hemorrhagic stroke edema. The investigators~     selected 80 hemorrhagic stroke patients , and who the stroke is first attack, they were~     randomly divided into control and experimental groups, and each group was 40 patients as~     follows: 1) control group, accepted AM placebo 2.8 g three times per day (tid) treatment for~     continuously 14 days from second day of admission or operation, except standard ordinary~     treatment; 2) experimental group, accepted AM 2.8 g tid treatment for continuously 14 days~     from second day of admission or operation, except standard ordinary treatment. Computer~     tomography (CT) examination was done at first day, 4th day and 7th day of admission,~     respectively. The ratio of brain edema was calculated by CT image, and inflammatory index~     including the levels of C-reactive protein (CRP), erythrocyte sedimentation rate~     (ESR)，Creatine Kinase BB Isoenzyme (CMBB). D-dimer from venous blood also were measured. In~     addition, the score including Glasgow outcome scale (GOS), Modified rankin scale (MRS),~     Function independence measure (FIM), Barthel index (BI) was recorded one week, four weeks and~     12 weeks after admission or surgical operation, as an index for clinical symptoms. The index~     for the therapeutic effect of AM was according to above-mentioned the ratio of brain edema,~     inflammatory index and clinical symptoms.~      The investigators expected the results of the present study may provide a scientific evidence~     for the hemorrhagic stroke edema treatment of AM, thus, the present study may contribute to~     use the method of integrated Chinese and Western Medicine for the treatment of stroke, and to~     the research of Chinese Medicine.~   "
163297|NCT01428388|"~     Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in~     treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most~     widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been~     FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used~     off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab is~     less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month~     randomized, prospective interventional trial comparing the effectiveness of ranibizumab with~     bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change~     in central retinal thickness. Secondary measures are change in visual acuity from baseline~     and change in angiographic properties of macular lesions from baseline after treatment.~   "
163298|NCT01428375|"~     This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of~     Paracetamol as intrapartum analgesic in the first stage of labour.~   "
163299|NCT01428362|"~     The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and~     effective as a daily treatment for Alzheimer's disease that is worsening despite current~     treatment.~   "
163300|NCT01428349|"~     This is a 2 -year NIDA funded grant (Co-PIs: Joseph P. Newman, John Curtin, and Carl Lejuez)~     that examines whether recent progress in characterizing the cognitive deficits associated~     with psychopathic and externalizing offenders may be used to develop better therapeutic~     interventions to treat their substance abuse and other self-control problems. Inmates with~     externalizing or psychopathy will receive one of two computer-based interventions to~     remediate the core cognitive skills that have been linked to self-regulation deficits in the~     two groups. One intervention (ACC) targets the affective cognitive control deficits~     associated with externalizing offenders whereas the other intervention (ATC) targets the~     attention to context deficits associated with psychopathic offenders. The specific components~     of the project include: selection and randomization of inmates; pre- and post-treatment~     behavioral and brain-related (ERP and Startle) measures to evaluate the impact and~     specificity of the ACC and ATC treatments; and 6 sessions of behavioral (e.g. computerized)~     and verbal training in ACC or ATC.~   "
163301|NCT01428336|"~     The diagnosis of secondary AI is vital to prevent catastrophic events in patients. An optimal~     test should have a very low margin of error with high sensitivity and specificity, be easy~     and safe to administer, and have distinct cut off values. Both 1 ug and 250 ug doses have~     their limitations. Based on our experience over the past six years, we hypothesize that 25 ug~     ACTH stimulation test may eliminate some of the shortcomings of the LDST (1 ug) and SDST (250~     ug). This is supported by our preliminary data and the study by Oelkers et al, which looked~     at ACTH levels following various doses of cortrosyn injections.~      Therefore we propose a head to head comparison of 25 ug, 250 ug and 1 ug dose using ITT as~     gold standard.~   "
163302|NCT01428323|"~     Open-vent jet nebulizers are frequently used to promote drug lung deposition but their~     clinical efficacy and indications are not clear.~      Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet~     nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a~     110 ml corrugated piece of tubing.~   "
163303|NCT01428310|"~     This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the~     effects of study product on a smoker's desire to smoke, measured by changes in scores on~     questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will~     self-administer the study product and visit the study site for assessment of desire to smoke~     and collection of samples for the evaluation of smoking-related biomarkers.~   "
163304|NCT01428297|"~     The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in~     Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be~     assessed in two different patients groups to evaluate safety and efficacy in atopic~     dermatitis (Part 2) and in Netherton syndrome (Part 3).~   "
163306|NCT01428271|"~     Caudal block is one of the most useful and popular regional block in pediatric anesthetic~     practice. Successful caudal block depends on the proper placement of a needle through sacral~     hiatus by following anatomical landmarks. The sacrum and the position of sacral hiatus are~     extreme variable anatomical structure. Generally, the equilateral triangle located between~     the apex of the sacral hiatus and posterior superior iliac spines is used in determining the~     location of the sacral hiatus as the conventional method. Previous study demonstrated that~     the triangle formed between the apex of the sacral hiatus and the posterior superior iliac~     spines was found to have the features of an equilateral triangle in adult. There is no study~     about the efficacy of the conventional method using the equilateral triangle in children. In~     this study, the investigators will compare between the expected site of sacral hiatus by~     conventional method using the equilateral triangle and the real site of the sacral hiatus~     confirmed by ultrasonography for caudal block in children.~   "
163307|NCT01428258|"~     For individuals with Phenylketonuria (PKU), the investigators hypothesize that~     glycomacropeptide will provide an acceptable form of low-phenylalanine dietary protein that~     will improve dietary compliance, blood phenylalanine levels, cognitive function, and~     ultimately quality of life compared with the usual amino acid based diet. The study is funded~     by the Food and Drug Administration (FDA) Office of Orphan Products Development Grants~     Program, R01 FD003711.~   "
163308|NCT01428245|"~     Gonadotropin-releasing hormone (GnRH) is a hormone that regulates the ability of the~     pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone~     (FSH). LH and FSH control the production of female hormones (such as estrogen and~     progesterone) and the development of eggs by the ovary. Progesterone and estrogen then~     decrease the number of GnRH pulses produced by the brain (and therefore the number of LH~     pulses from the pituitary). The ability to decrease GnRH pulses seems to be very important~     for normal menstrual function in adult women. The purpose of this study is to learn more~     about how GnRH and LH pulses are controlled during puberty. The information gathered in this~     study will hopefully allow us to learn more about how menstrual cycles are normally~     established in girls during puberty.~   "
163309|NCT01428232|"~     A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo~     to compare rates of early initiation and exclusive breastfeeding between mothers who give~     birth in hospitals with the current standard of care, mothers who give birth in hospitals~     that have implemented the first nine steps of the Baby-Friendly Hospital Initiative, and~     mothers who give birth in hospitals that have implemented all ten steps of the Baby-Friendly~     Hospital Initiative, with the 10th step being the provision of breastfeeding support during~     well-child clinic visits.~   "
163310|NCT01428219|"~     The purpose of this study is to look at the effects of cabozantinib on castrate-resistant~     prostate cancer metastatic (cancer that has spread to other parts of the body) to the bone~     and to learn about any side effects caused by taking cabozantinib.~   "
163311|NCT01428206|"~     Liverpool Care Pathway for the dying patient (LCP) was developed to transfer the care~     practice from the hospice setting to the hospital setting in UK. LCP is a pathway with~     standardized registration method to monitor the care and its results. The primary aim is to~     study the effects of LCP on dying patients symptom burden and communication with close~     relatives and health care professionals.~   "
163312|NCT01428193|"~     The purpose of this study is to understand the effects of elevated male hormones in~     adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If~     the investigators understand the effects of elevated male hormones levels in girls, the~     investigators may be able to better treat girls with elevated male hormone levels and perhaps~     even learn how to prevent the development of PCOS. Females with elevated levels of male~     hormones respond differently to estrace (estradiol) and progesterone than females with normal~     male hormone levels. The investigators will be giving you estrogen and progesterone to see~     how you respond after the male hormone has been blocked by a medication called flutamide.~   "
163313|NCT01428180|"~     The purpose of this study is to examine the influence medical or surgical treatment for~     patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on~     cardiac output.~   "
163314|NCT01428167|"~     Thyroid cancer (TC) is the most common endocrine malignancy. The association between~     inflammation and cancer is well established but the association between thyroiditis~     (inflammation of thyroid gland) especially Hashimoto's thyroiditis (HT) and thyroid cancer~     remains controversial. Chronic inflammation leads to a repeated cycle of cellular damage and~     subsequent healing which contributes to inappropriate cell proliferation and subsequent~     neoplastic transformation. One of the most common forms of Thyroiditis is Hashimoto's~     thyroiditis which is a chronic autoimmune inflammatory disease affects almost 5% of the~     population and is more common in women. For the first time, Dailey and Lindsay reported in~     1955 an increased association between Hashimoto's Thyroiditis (HT) and thyroid cancer. They~     reported 35 thyroid cancers in 278 patients with Hashimoto's Thyroiditis, a prevalence of~     17.7% which they considered higher than the general population . Since then, various studies~     have been done, some studies have reported an increased risk of malignancy in Hashimoto's~     thyroiditis; others have failed to find an association. Most of the studies that have been~     done to identify the association between Hashimoto's thyroiditis and thyroid cancer are~     retrospective. The purpose of this pilot case-control study is to identify the association of~     Hashimoto's thyroiditis and thyroid cancer, to determine if the presence of Hashimoto's~     thyroiditis has any affect on the complication of thyroidectomy and prognostic factors of~     thyroid cancer.~   "
163315|NCT01428154|"~     The purpose of this study is to find out more about darbepoetin alfa in children less than 1~     year of age with anemia (a decrease in red blood cells) due to kidney failure. This study~     will see if darbepoetin alfa is safe and well tolerated and whether it causes any side~     effects by taking blood samples and checking vital signs (heart rate, body temperature, and~     blood pressure tests) at specific times throughout the study. In addition, the study will~     evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in~     the blood to evaluate how darbepoetin alfa works on anemia.~      Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and~     European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric~     subjects. Therefore, studies need to be conducted in pediatric subjects (children) to~     determine the appropriate dose to use in younger children.~   "
163317|NCT01428128|"~     Many types of cancer are treated with chemotherapy drugs and/or radiation therapy. These~     forms of treatment, however, can also damage normal (non-cancer) cells and cause a variety of~     side effects. There are many side effects of chemotherapy. A few examples are: lowered red~     blood cell counts (anemia) which can lead to tiredness, weakness or shortness of breath;~     lowered white cell counts (white blood cells which help the body to fight infection); low~     platelet counts (platelets help blood to clot); nausea and vomiting; diarrhea; lip and mouth~     sores and hair loss. These side effects can range from mild to severe. P53 is a protein in~     the body that regulates the cell cycle. If a cell becomes damaged from chemotherapy or~     radiation treatment, the p53 protein becomes activated. This activation can cause the cell to~     die and is involved in causing side effects from chemotherapy or radiation therapy.~      Arsenic trioxide is a drug that is currently approved by the FDA (Food and Drug~     Administration) for the treatment of acute promyelocytic leukemia (APL), which is a type of~     blood and bone marrow cancer. It is given by I.V (intravenous, by vein). New preclinical~     studies have shown that when given in smaller than normal doses before treatment with~     chemotherapy and/or radiation therapy, the arsenic trioxide can block the activation of p53~     and protect normal tissues from treatment damage. Preclinical means that the studies have~     been done in a laboratory and not on humans.~      This study has two purposes. The first is to find the dose range for arsenic trioxide that~     will block p53 activity. This dose has been determined from the first five subjects who took~     part in the study and received arsenic trioxide. The dose of arsenic trioxide for this study~     is about 1/30 of the normal dose given when arsenic trioxide is used to treat acute~     promyelocytic leukemia. The second is to see if the arsenic trioxide will decrease the side~     effects of chemotherapy. In this study, arsenic trioxide is investigational.~     Investigational means that arsenic trioxide has not yet been approved by the FDA to block~     p53 activity.~      This study will help find out what the smallest (best) dose is that can be given and the~     effects, good and/or bad, this drug has on people who take it. The safety of this drug in~     humans has been tested in prior research studies; however, whether the side effects will~     still be present at this lower dose is not yet known.~   "
163318|NCT01428115|"~     It has been shown that emotional health issues, such as state anxiety, are more prevalent in~     patients suffering from inflammatory bowel disease (IBD) compared to physically healthy~     subjects.~      Such findings have to be taken into consideration when making an educated guess that~     psychological factors such as depression and anxiety in particular interact with the course~     of Crohns disease. Therefore the treatment of the underlying disease may have a significant~     influence on the level of psychological disorders.~      Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α) antibodies~     ameliorates the emotional/psychological status of patients, however the impact of adalimumab~     therapy on anxiety correlated with the status of inflammatory bowel disease (IBD) remains~     unclear.~      The primary objective of this study was to describe and evaluate changes in levels of anxiety~     assessed by validated patient questionnaires after 6 months of treatment with adalimumab.~   "
163319|NCT01428102|"~     During normal physiological conditions hemostasis (the ability of blood to clot) is kept in~     homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex~     series of steps on both sides of the coagulation cascade including cellular components (i.e.~     clot formation and breakdown). However, should this homeostatic balance be upset, normal~     hemostasis is affected resulting in pathological clotting (vessel blockage) or bleeding~     (hemorrhage). In instances that include acquired or congenital abnormalities of the~     hemostatic system it is clinically important to diagnose, monitor and manage the patient to~     optimize therapeutic intervention. Moreover, it is important to regulate the hemostasis~     system in the post-surgical outpatient who receives oral anticoagulant therapy to maintain~     the homeostatic balance.~      The TEG® analyzer, using a small whole blood sample, documents the interaction of platelets~     with the protein coagulation cascade from the time of placing the blood in the analyzer until~     initial fibrin formation, clot rate strengthening and fibrin-platelet bonding via GPIIb/IIIa,~     through eventual clot lysis. It displays both qualitatively and quantitatively the two~     distinct parts of hemostasis - the part that produces the clot and the part that causes the~     breakdown of the clot. It shows the balance or degree of imbalance in the patient's~     hemostasis system, highlights any areas of deficiency or excess, and offers a precise view of~     the patient's hemostasis condition. If the system is not in balance, one can see where the~     imbalance lies. If a patient is bleeding, it is crucial to determine the cause of bleeding as~     soon as possible in order to start the proper treatment.~      By utilizing a kaolin/tissue factor activator (RapidTEG™), the TEG® system can measure the~     interaction and simultaneous contribution of the intrinsic and extrinsic coagulation pathways~     which initiate and result in clot formation. This RapidTEG™ reagent can deliver results~     faster than activating with Kaolin alone. This protocol will specifically assess one~     algorithm called MA. MA is a direct function of the maximum dynamic properties of fibrin and~     platelet bonding via GPIIb/IIIa that represents the ultimate strength of the fibrin clot.~     This represents platelet function.~      The objective of the study is to demonstrate the substantial equivalence of MA RapidTEG vs.~     MA Kaolin.~   "
163320|NCT01428089|"~     During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH),~     luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are~     very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they~     initially do so at night only. It is unknown why GnRH and LH pulses increase at night and~     then decrease during the day (instead of being increased all the time). The purpose of this~     study is to see how quickly progesterone reduces LH pulses. The study is also meant to find~     out whether too much testosterone (also a hormone) in the blood causes problems with the~     ability of progesterone to reduce LH pulses. In this study, the investigators aim to discover~     whether or not giving 3 small doses of progesterone to pubertal girls will prevent the~     nighttime increase of LH pulses. From the information gathered in this study, the~     investigators may be able to learn more about how menstrual cycles are normally established~     in girls during puberty. Ultimately, if the investigators understand these normal processes,~     the investigators may be able to better understand abnormalities of puberty.~   "
163321|NCT01428076|"~     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and~     may cause discomfort. In this study, patients with varicose veins in the legs will be~     participating. The purpose of this research study is to evaluate the pharmacokinetic profile~     of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an~     investigational treatment for varicose veins.~   "
163322|NCT01428063|"~     The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received~     placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and~     determine whether addition of these drugs results in higher cure rates in patients who~     previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS~     study NCT01428063 (AI447-028) will receive active drugs in this study.~   "
163323|NCT01428050|"~     The Whipple operation is a complex surgical procedure involving the removal of the head of~     the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for~     patients who have cancer or some other condition affecting this region of the body. The~     Whipple operation is associated with a significant complication rate. Previous studies have~     shown that in a broad range of surgical procedures, using a reduced amount of intravenous~     fluids along with a special type of fluid called hypertonic saline during and after the~     procedure can lower complication rates associated with the heart and lungs during recovery~     from surgery. The purpose of this study is to determine if using a reduced amount of~     intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous~     fluids) during the Whipple operation and in the immediate period after surgery can reduce~     complications.~   "
163324|NCT01428037|"~     The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal~     misoprostol for cervical ripening and induction of labour.~   "
163327|NCT01427998|"~     Background: Animal studies indicate that olive leaf extract normalizes blood glucose. We~     hypothesized that olive leaf extract might be of benefit in human subjects.~      Methods: A total of 79 adults with diabetes were randomly assigned to treatment with olive~     leaf extract capsules or matched placebo. Measures of glucose homeostasis including glucose,~     insulin and HbA1c were measured and compared by treatment group.~   "
163328|NCT01427985|"~     The purpose of this study is to examine the influence of premedication drugs Atropin,~     Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac~     output in term and preterm newborn infants. Two different protocols of premedication are~     compared.~   "
163329|NCT01427972|"~     The purpose of this trial is to investigate the safety and efficacy of LY2623091 in males and~     females with chronic kidney disease.~   "
163330|NCT01427959|"~     Tampere Traumatic head and brain injury study is a prospective study aiming to explore~     neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic~     brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi.~     The study is conducted in Tampere University Hospital's emergency department between the 1st~     of August 2010 and 31st of July 2013.~   "
163331|NCT01427946|"~     Study IPI-504-15 is a Phase 1b/2 clinical trial to evaluate the safety and efficacy of~     retaspimycin HCl (IPI-504) plus everolimus in patients with KRAS mutant Non-small Cell Lung~     Cancer (NSCLC).~   "
163332|NCT01427933|"~     This is a study to compare the antitumor activity of ramucirumab (IMC-1121B) and eribulin~     together versus eribulin alone, in participants with locally recurrent or metastatic breast~     cancer.~   "
163333|NCT01427920|"~     This trial was conducted in Asia, Europe and South America. The aim of this trial was to~     confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin~     aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in~     glycosylated haemoglobin (HbA1c).~   "
163334|NCT01427907|"~     The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and~     sevelamer carbonate in maintaining serum phosphorus levels~      This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the~     equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer~     carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim~     of the study is to maintain serum phosphorus level and establish equivalence between COS and~     sevelamer carbonate tablets.~   "
163335|NCT01427894|"~     Study objective is to evaluate the additive effect of maternal singing during skin to skin~     contact (Kangaroo Care) on anxiety reduction both to infants and their mothers.~   "
163336|NCT01427881|"~     This phase II trial studies how well cyclophosphamide works in preventing chronic~     graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients~     with hematological malignancies. Giving chemotherapy and total-body irradiation before~     transplantation helps stop the growth of cancer cells and prevents the patient's immune~     system from rejecting the donor's stem cells. Healthy stem cells from a donor that are~     infused into the patient help the patient's bone marrow make blood cells; red blood cells,~     white blood cells, and platelets. Sometimes, however, the transplanted donor cells can cause~     an immune response against the body's normal cells, which is called graft-versus-host disease~     (GVHD). Giving cyclophosphamide after transplant may prevent this from happening or may make~     chronic GVHD less severe.~   "
163337|NCT01427868|"~     The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of~     LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg)~     tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.~   "
163338|NCT01427855|"~     There is growing epidemiological evidence that consumption of red meat is associated with~     greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods.~     Research from our group has shown that a high saturated fat (SF) diet with a moderate red~     meat content selectively increases intermediate density lipoproteins (IDL) and larger low~     density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller~     LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef~     consumption results in a preferential increase in small and medium LDL particles that are~     strongly related to CVD. To date, no studies have directly compared the lipoprotein effects~     of red meat with that of other food sources of protein in the context of both high and low~     saturated fat intake.~      The overall objective of this project is to test the hypothesis that the effects of SF on~     lipoprotein markers of CVD risk are influenced by sources of dietary protein. The~     investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol (C),~     apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a high~     content of red meat than in diets in which the major proteins are from white meat (poultry)~     or non-meat sources. The investigators propose a clinical trial in which 180 healthy men and~     women will be randomized to high SF or low SF diet groups, and within each group, consume~     diets with equivalent amounts of protein from red meat, white meat, and non-meat sources for~     4 wks each in random order. Specifically, the investigators will test whether: (1) With high~     SF, the red meat diet, compared to the other protein sources, will result in higher levels of~     LDL-C, apoB, small and medium LDL, and total/high density lipoprotein (HDL)C; (2) With low~     SF, dietary protein source will not be related to any of these measurements; (3) With both~     the white meat and non-meat protein diets, increased LDL-C with high vs. low SF will be due~     primarily to increases in large LDL, whereas with red meat the additional increase in small~     and medium LDL will result in greater increases in plasma apoB and total LDL particle number.~     Aim 4 will test hypotheses that increases in small and medium LDL with high SF plus red meat~     are related to increased activity of hepatic lipase, a key determinant of small LDL~     production, and that increases in large LDL induced by high SF are related to suppression of~     LDL receptors. The investigators will also assess the effects of protein source and saturated~     fat content on markers of insulin resistance, inflammation and endothelial function.~   "
163339|NCT01427842|"~     Current Australian guidelines for vancomycin commonly underdoses individuals particularly in~     the first 48 hours.~      The aim of the trial is to compare two dosing regimens; the current Australian guidelines~     versus a more appropriately modeled pharmacokinetic based regimen with the overall aim of~     developing a new vancomycin dosing strategy that will enable patients to have more~     individualised and therapeutically efficacious treatment.~      The hypothesis is that dosing vancomycin according to a pharmacokinetically modeled regimen~     increases the likelihood of achieving therapeutic trough levels of vancomycin within the~     first 48 hours (or at steady state, whichever is sooner) compared to dosing vancomycin~     according to the current Antibiotic guidelines.~   "
163340|NCT01427829|"~     The purpose of this study was to examine preliminary effect of Computer-assisted Psychosocial~     Risk Assessment tool (CaPRA) among Afghan refugees visiting medical professionals (family~     physicians or nurse practitioners) at a Community Health Center. The investigators examined~     the tool's acceptability among patients and its impact on patient satisfaction and patient~     intention to visit a psychosocial counselor as a proxy of potential to integrate medical and~     social care.~   "
163341|NCT01427816|"~     To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye~     syndrome.~   "
165270|NCT01402466|"~     The study will test an intervention to help HIV-positive people achieve consistency of HIV~     care while transitioning in and out of jail.~   "
163342|NCT01427803|"~     An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of~     Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the~     frequency at which consumers exceed the label-defined daily dose, thus putting themselves at~     clinical risk, and 2) the reasons for exceeding the labeled daily dose.~   "
163343|NCT01427777|"~     The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1~     Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male~     subjects aged 9 to 15 years.~   "
163344|NCT01427764|"~     Periodontal instrumentation aims to remove plaque and calculus from the root surface. Both~     manual and ultrasonic instruments have been used for such decontamination; however,~     establishing a healthy periodontium can result in adverse effects, such as dentin~     hypersensitivity. The aim of this study was to evaluate the effects of hand or ultrasonic~     instrumentation on dentin hypersensitivity in patients undergoing non-surgical periodontal~     treatment. For this controlled clinical trial of a split mouth design, 14 patients were~     selected with homologous teeth in the incisor to premolar region and probing depth ≥ 5 mm on~     the buccal aspect of the teeth. One side (control) was instrumented with hand instruments and~     the other side (test) with ultrasonic instruments. Dentin hypersensitivity was assessed in~     the baseline and during the follow 4 weeks after treatment, with a periodontal probe~     scratching the root surface and with an air jet. The patient's response was detected by a~     visual analog scale (VAS) of 10 cm.~   "
163345|NCT01427751|"~     This study will evaluate the safety and efficacy of dexamethasone intravitreal implant~     (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion~     (BRVO).~   "
163346|NCT01427738|"~     The purpose of this study was to see which one of two medicines (topical gentian violet [GV]~     or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC).~     This was measured by whether the study participant still had OC or sores in his/her mouth~     after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the treatment~     of OC were assessed.~   "
163347|NCT01427725|"~     This study aims at collecting the information related to the safety and effectiveness in the~     pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long~     term in order to evaluate the effective and safe use of LipaCreon.~   "
163348|NCT01427712|"~     This study aims at collecting the information related to the safety and effectiveness in the~     pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment~     with LipaCreon in order to evaluate the effective and safe use of LipaCreon.~   "
163349|NCT01427699|"~     The purpose of this study is to determine if T2-18C3, a true human monoclonal antibody that~     blocks inflammation, is safe to use in patients with type 2 diabetes. The study will also be~     looking at the ability of T2-18C3 to improve control of blood sugar levels in diabetics by~     blocking inflammation in the pancreas.~   "
163350|NCT01427686|"~     The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in~     term and preterm neonates with arterial hypotension on cerebral and renal oxygenation,~     fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output.~      The investigators hypothesize that Dopamine has a stronger effect on blood pressure than~     Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output~     than Dopamine.~   "
163351|NCT01427673|"~     The purpose of this study is to determine if Bipap should assume a standard-of-care role in~     the management of overlap syndrome.~   "
163352|NCT01427660|"~     Two of AHRQ 's consumer-focused guides, Pills for Type 2 Diabetes and Premixed Insulin for~     Type 2 Diabetes could be of great use to underserved ethnic and racial minority adults. The~     presentation of content and delivery mechanisms of these Guides, however, needs to be~     modified to increase their use and impact among these difficult-to-reach populations.~      To achieve this goal, a long-standing collaboration among African American and Latino~     community organizations, health care centers and systems, public health organizations, and~     academics (the REACH Detroit Partnership) is joining with leading experts in the development~     of personally and culturally tailored health decision aids (University of Michigan's Center~     for Health Communications Research [CHCR] and Center for Behavioral and Decision Sciences in~     Medicine [CBDSM]).~      The investigators will develop and evaluate a computer tailored online diabetes medication~     decision aid that will enable community health workers (CHWs) to provide personalized patient~     education materials to underserved diabetic African American and Latino adults in Detroit,~     Michigan.~   "
163353|NCT01427647|"~     Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative~     outcome following colorectal cancer surgery. The investigators hypothesize that the~     inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared~     to traditional open surgery under general anesthesia.~   "
163354|NCT01427634|"~     The primary aim of the study is to provide proof of concept to demonstrate that patients~     with Ventricular Assist Devices (VADs) and caregivers are willing to be enrolled in a~     randomized trial of palliative care and that such a study is feasible. Secondary aims include~     demonstrating improvement in symptoms (physical and psychological) for intervention patients~     and their caregivers as compared to control patients and caregivers. The investigators will~     also examine differences in utilization of healthcare services, mortality, and completion of~     advance directives between intervention and control patients.~   "
163355|NCT01427621|"~     Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the~     postoperative course of the patients. The investigators hypothesized that RIPCcom, combined~     intervention of remote ischemic preconditioning and remote ischemic postconditioning, would~     confer beneficial influence on inflammatory response and resultant postoperative pulmonary~     dysfunction after CPB in patients undergoing complex valvular heart surgery who are at~     increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate~     the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients~     undergoing complex valvular heart surgery.~   "
163377|NCT01427335|"~     There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous~     calcium is a novel protocol. But still there is lack of evidence of it is real effect in~     prevention of OHSS & the mechanism of its action is still questionable . In the study the~     investigators try to search for the evidence for its effect & the real mechanism for its~     action.~   "
163356|NCT01427608|"~     The acute phase of this study will monitor the response to a combination of an atypical~     antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute~     treatment of the disorder. It is predicted that this combination will improve symptoms of~     psychotic depression and be associated metabolic side effects. Factors that moderate~     tolerability will be monitored. Improvement in symptoms could take between 4 and 12 weeks,~     followed by a period of 8 weeks during which participants will continue to take the same~     medications to stabilize the remission from symptoms of psychotic depression.~      The maintenance phase will be a randomized, double-blind, placebo-controlled study of~     olanzapine for a period of up to 36 weeks to test whether continuing this combination~     decreases the risk of relapse and whether discontinuing the combination leads to improvement~     in metabolic measures. Subjects who complete the acute phase will be asked to consent~     separately to the randomized maintenance phase.~   "
163357|NCT01427595|"~     Many, but not all, girls with high levels of the male hormone testosterone go on to develop~     polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual~     periods, excess facial and body hair, and weight gain. PCOS is also a leading cause of~     difficulty becoming pregnant. The investigators do not understand why some girls with high~     hormones develop PCOS and others do not. In a previous study by our group, some girls with~     high levels of male hormones had abnormalities in the secretion of another hormone, called~     luteinizing hormone (LH), that are often seen in women with PCOS. However, another group had~     normal LH secretion. The girls with the abnormal LH secretion had higher levels of another~     hormone, called insulin, than the girls with normal LH secretion. The investigators will test~     whether metformin, an insulin-sensitizing agent, changes the effects of high male hormone~     levels in adolescent girls, specifically by looking at their LH secretion response following~     metformin treatment.~   "
163358|NCT01427582|"~     The YONDELIS (trabectedin) Single Patient Compassionate Use /Expanded Access program provides~     patients with advanced soft tissue sarcoma, who do not qualify for ongoing clinical trials~     with YONDELIS (trabectedin), access to this investigational treatment.~   "
163359|NCT01427569|"~     The purpose of this study is to determine if topical application of a hydrogel that contains~     plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a~     hydrogel alone.~   "
163360|NCT01427556|"~     This study is exploring the relationship between food intake behavior and the~     hypothalamic-pituitary axis (HPA) in women who regularly skip breakfast compared to women who~     regularly eat breakfast.~   "
163361|NCT01427543|"~     The goal of this study is to determine whether a culturally congruent, group intervention can~     reduce HIV risk behaviors among recently incarcerated, bisexual, African American men.~   "
163362|NCT01427530|"~     This study will be recording and evaluating brain activity from Deep Brain Stimulating (DBS)~     electrodes in patients with Parkinson's disease.~   "
163363|NCT01427517|"~     The investigators are interested in determining if the investigators are able to detect~     changes in brain chemistry using Magnetic Resonance Spectroscopy (MRS) in individuals with~     Parkinson's disease (PD), those with Gaucher's disease (GD), and those without neurological~     disorders (healthy controls) when they are given the antioxidant N-acetylcysteine (NAC). This~     study will combine information from a medical history, a physical examination and disease~     rating scales with results obtained using MRS brain scans and pharmacokinetic studies from~     blood samples. This research will require 1 visit that will require about 4 to 5 hours of~     time. During this study, participants will provide their medical history, be examined and~     undergo a rating scale for about one hour; the brain scan and pharmacokinetic studies will~     require 1.5-2 hours of time; in total the study will take about 4-5 hours.~   "
163364|NCT01427504|"~     The investigators believe that boceprevir's drug concentrations will be reduced when~     administered in combination with etravirine. The investigators believe that etravirine's drug~     concentrations will be increased when administered in combination with boceprevir.~     Additionally, the investigators believe that boceprevir and etravirine are safe when~     administered alone or in combination.~   "
163365|NCT01427491|"~     The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to~     manage bioburden in leg ulcers over a two week study period.~   "
163366|NCT01427478|"~     The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance~     therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2~     every 3 weeks)in squamous cell carcinoma of the head and neck.~   "
163367|NCT01427465|"~     The primary aim of this research is to test the efficacy of innovative, brief alcohol abuse~     prevention strategies that integrate positive youth development messages and health risk~     messages for adolescents in high school settings. A secondary aim is to examine these~     strategies in various combinations as interventions and re-interventions (i.e., boosters) for~     sustaining or enhancing behavior change over time. These strategies are founded upon an~     emerging conceptual framework titled the Behavior-Image Model emanating from findings of our~     recent trials examining multiple behavior health interventions. The long-term objective of~     this project is to reduce alcohol abuse and problems among older high-risk adolescents for~     whom alcohol and drug use disparities exist, yet who are often overlooked in prevention~     research and services.~   "
163378|NCT01427322|"~     Lapatinib will prevent radiation-induced increase in Transforming Growth Factor alpha (TGFα),~     an important growth factor in cancer cell recovery after ionizing irradiation.~   "
163379|NCT01427309|"~     The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard~     dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza~     types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for~     culture-confirmed) to those contained in the respective annual vaccine formulations.~      Primary Objective:~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to laboratory-confirmed influenza caused by any influenza viral~          types/subtypes, associated with the occurrence of a protocol-defined~          influenza-like-illnesses (ILI).~      Secondary Objectives:~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to laboratory-confirmed influenza, caused by any influenza viral~          types/subtypes, associated with the occurrence of a protocol-defined ILI.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza, caused by any influenza viral~          types/subtypes, associated with the occurrence of a protocol-defined ILI.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza caused by viral types/subtypes~          antigenically similar to those contained in the respective annual vaccine formulations,~          associated with the occurrence of a modified Centers for Disease Control and Prevention~          (CDC)-defined ILI.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza caused by any influenza viral~          types/subtypes, associated with the occurrence of a modified CDC-defined ILI.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza caused by viral types/subtypes~          antigenically similar to those contained in the respective annual vaccine formulations,~          associated with the occurrence of a respiratory illness.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza caused by any influenza viral~          types/subtypes, associated with the occurrence of a respiratory illness.~   "
163380|NCT01427296|"~     The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus~     HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.~   "
163874|NCT01420835|"~     The purpose of this study is to assess stress levels and quality of life in the nursing team~     of Samaritan Hospital and evaluate the effectiveness of Chinese auriculotherapy used with and~     without closed protocol on reducing the stress levels and improvement of life quality.~   "
163368|NCT01427452|"~     Live donor kidney transplantation (LDKT) is important because its outcomes for recipients are~     superior to those of deceased donor transplantation, and it yields significant cost savings~     to the healthcare system overall. Despite efforts over the past few decades to enhance~     understanding of the short- and long-term outcomes of living kidney donation, it is clear~     that investigators have more knowledge in some areas (e.g., surgical and medical~     complications) than in others (e.g., psychological outcomes, financial impact). While the~     transplant community and changes in federal regulations have brought attention to the need~     for more systematic study of living donor outcomes, there remains a paucity of scientifically~     rigorous multisite, prospective outcome studies. The long-term goal of this research program~     is to characterize the short- and long-term surgical, medical, functional, psychological, and~     financial outcomes of living kidney donation. The objective of this study is to establish a~     multisite prospective cohort of living kidney donors, their recipients, and a healthy~     comparison group. This cohort will be used to examine three primary aims: (1) to assess donor~     outcomes (surgical, medical, functional, psychological, financial) over a 2-year period~     initially, with the intention of examining these outcomes over a more extended time period in~     subsequent years; (2) to identify the donor, recipient, and center variables that are most~     predictive of donor outcomes; and (3) to identify disparities in donor outcomes and their~     predictors. To accomplish these aims, six kidney transplant programs, representing six states~     (Massachusetts, Maine, Rhode Island, New York, Iowa, and Arizona) and with experience and~     expertise in caring for living donors and transplant recipients, will participate in the~     study. Donors, their recipients, and healthy controls will complete comprehensive assessments~     at baseline (pre-surgery) and at 1, 6, 12, and 24 months post-donation. This study will~     extend the investigators considerable preliminary work by simultaneously examining outcomes~     that are of importance to donors, recipients, healthcare providers, and policymakers. The~     rationale for this research is that, once these outcomes and their predictors are known,~     investigators can further develop and refine educational strategies and informed consent~     processes for both living donors and their intended recipients, as well as provide systematic~     data to inform policy discussions and clinical care practice.~   "
163369|NCT01427439|"~     The purpose of this study is to describe patient functioning and examine associations between~     depressive symptoms and measures of the various roles of functioning.~   "
163370|NCT01427426|"~     Factors Group is a producer of nutritional supplements. This study aims to determine whether~     one of their products improves the energy and sense of well-being in individuals who consume~     it. Interested subjects will complete a 1 week lead-in phase where they will be asked to~     consume a placebo daily to see if they are a good fit for the study. After the lead-in phase,~     subjects will be randomized to take either All Greens or a different placebo for 12 weeks.~     The investigators expect All Greens to have better results than the placebo, but subjects~     will not know which supplement they are taking. The primary outcome is a score on a~     questionnaire of well being.~   "
163371|NCT01427413|"~     While the number of assisted reproduction cycles increases worldwide, the introduction of~     actual technological improvements in the ability to quickly and non-invasively identify the~     best embryos for transfer still represents a critical goal for reproductive medicine. Indeed,~     embryo assessment is currently performed through the analysis of morphology and cleavage~     rate. Recent studies have sought to identify a correlation between qualitative-quantitative~     profiles of small molecules of metabolic interest and the outcome of embryo transfer. Some of~     these molecules seem to be best suited for this purpose, including glucose, lactate, pyruvate~     or amino acid levels. Approaches relying on both optical and non-optical spectroscopy have~     been proposed to non-invasively monitor the embryo culture media. However, the non-invasive~     approach only offers an indirect strategy to monitor embryos and a turn-around solution to~     bypass the limits of detection of these analytical techniques. In this paper the~     investigators pave the way for direct assessment of embryos through the mass~     spectrometry-based analysis of blastocoele fluid, which is withdrawn from the blastocoele~     cavity prior to cryostorage of blastocysts. The investigators show how it is possible to~     detect most of the already documented metabolites of interest right at the very heart of the~     blastocyst, without disrupting the workflow of a classic laboratory pipeline.~   "
163372|NCT01427400|"~     Breast reconstruction is a common procedure with over 86,000 breast reconstruction procedures~     performed in the United States in 2009. This is a 1.5-fold increase since 2007. Of these~     breast reconstructions, 65% use a tissue expander/implant technique. Although satisfactory~     results can be achieved with a single-stage technique, a two-stage approach is considered~     more reliable, allowing for precise positioning of the inframammary fold and an opportune~     time to perform a capsulotomy to increase the breast skin flap by releasing the soft tissue.~      The placement of the tissue expander and implant under the chest muscles is thought to~     minimize the incidence of capsular contracture, expander exposure, and in addition, produce~     acceptable aesthetic results. However, discomfort is often associated with this submuscular~     placement of a tissue expander or implant, specifically during the expansion phase. Patients~     undergoing immediate reconstruction using submuscular implants have been shown to have higher~     analgesic requirements and to have higher pain scores post-operatively, compared to~     non-reconstructed patients. An uncomfortable reconstruction can lead to under-filling of the~     expander, a longer expansion process, abandonment of reconstruction, and a compromised~     quality of life. The use of Botulinum Toxin A (Botox) injections into the chest muscles at~     the time of surgery may help ease the discomfort that is often associated with this~     procedure.~      The investigators propose a prospective double-blind randomized placebo-controlled trial of~     patients undergoing tissue expander/implant reconstruction. The information gathered from~     this analysis will provide a greater understanding of the effects of Botox in the setting of~     two-stage tissue expander/implant breast reconstruction, with the goal to improve patient~     satisfaction and quality of life.~   "
163373|NCT01427387|"~     A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition,~     pre-prandial and postprandial administrations, is compared.~   "
163374|NCT01427374|"~     Individuals with kidney disease are at a higher risk for heart and vascular diseases,~     including heart attacks and strokes, than those with normal kidney function. The purpose of~     this research study is to collect information on the causes, complications and treatment of~     kidney disease. Patient characteristics, comorbid diseases and laboratory markers used in~     routine practice, as well as novel biochemical markers and genetic data will be collected to~     examine relationships between biochemical and genetic markers and cardiovascular risk.~     Information on the health history of incident hemodialysis and peritoneal dialysis patients~     will be captured using structured patient interviews and review of medical records. Blood and~     urine specimens will be collected at the time of dialysis initiation and stored in order to~     perform novel biochemical and genetic assays in the future. The overall goal of the~     CKDCS/LUCID study is improve understanding of cardiac-associated risks and to improve~     treatment in patients with kidney disease. A cardiac imaging substudy will be performed in a~     subset of patients enrolled. The goals of the substudy are to examine whether the risks of~     developing common cardiac-related complications (coronary artery calcification [CAC] and left~     ventricular hypertrophy [LVH]) are associated with certain medications taken by individuals~     on dialysis and whether these risks are modified by a genotypic predisposition.~   "
163375|NCT01427361|"~     The primary objective of this study is to investigate the accuracy of the femoral implant~     placement utilizing the VISIONAIRE Femoral Alignment Guide in Birmingham Hip Resurfacing~     (BHR) surgery postoperatively after total hip resurfacing using the BHR System.~   "
163376|NCT01427348|"~     The purpose of this study is to determine whether the head extension by an assistant~     decreases dental contact between laryngoscope blade and maxillary incisors during direct~     laryngoscopy~   "
163381|NCT01427283|"~     The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release~     tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone~     controlled-release tablets (OXY) in subjects with moderate to severe low back pain and~     opioid-induced constipation who require around-the-clock opioid therapy.~   "
163382|NCT01427270|"~     The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the~     management of opioid-induced constipation (OIC) compared to oxycodone controlled-release~     tablets (OXY) in subjects with moderate to severe low back pain and OIC who require~     around-the-clock opioid therapy.~   "
163383|NCT01427257|"~     Primary objective:~      To compare the pharmacokinetic profile of PB1023 after a single dose administered by~     subcutaneous injection of two formulations (concentrations).~      Secondary objectives:~      To evaluate the safety and tolerability of two formulations of PB1023 Injection administered~     as a subcutaneous injection in adult subjects with T2DM.~      To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of~     formulation B (100 mg/mL) administered cold at 2 to 8°C by subcutaneous injection.~   "
163384|NCT01427244|"~     This is a phase II open-label study of the activity and safety of trastuzumab in patients~     with vulvar Paget's disease with overexpression of HER2 on biopsy.~   "
163385|NCT01427231|"~     The objective of the current study is to determine the acute effect of a glucose drink and a~     sacharose drink compared to a placebo on cognitive performance in elderly with light memory~     complaints. The investigators expect that the sugar containing drinks will improve memory and~     attentional functions. Furthermore, blood glucose response will be measured.~   "
163386|NCT01427218|"~     Existing trials for the patient with coronary heart disease evaluate the interdisciplinary~     team dynamic where pharmacists (pharmacotherapists) provide therapeutic recommendations in~     the inpatient environment. To our knowledge, only other trial has evaluated the addition of a~     pharmacist (or nurse practitioner) in an outpatient collaborative cardiology practice and has~     found no benefit. However, the investigators believe that since a cardiology based pharmacist~     (pharmacotherapist) in the Veterans Health Administration has physical assessment skills, a~     shorter cycle length between appointments, and the ability to provide medication therapy~     management, the pharmacotherapist should be similarly successful as seen with other~     pharmacist based medication therapy management practices. The investigators will assess~     effectiveness by using the combined endpoint of blood pressure and lipid treatment.~     Additionally the investigators will conduct three substudies to evaluate if the pharmacist~     can improve all cause mortality and cardiovascular morbidity, adherence to antihypertensives,~     and patient satisfaction.~   "
163387|NCT01427205|"~     The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab~     can improve response. The safety of these drugs will also be studied.~      Objectives:~      Primary Objective(s): To assess progression-free survival (PFS) among patients with head and~     neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab plus OSI-906 and~     compare it with PFS among patients treated with cetuximab plus placebo.~      Secondary Objective(s):~        -  To assess the safety and toxicity of these treatment regimens.~        -  To assess the efficacy of these two treatment regimens in terms of overall survival,~          response rate, and disease control rate~        -  To assess the efficacy of single agent OSI-906 following cetuximab treatment in terms of~          response rate and disease control rate in patients who cross-over from Arm B to receive~          single-agent OSI-906~        -  To explore blood-based and tissue biomarkers~   "
163388|NCT01427192|"~     The purpose of this study is to study the differential short-term effect of nocturnal oxygen,~     acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms,~     exercise capacity and nocturnal breathing disturbances in subjects with pulmonary~     hypertension and sleep related breathing disorders~        -  Trial with medicinal product~   "
163389|NCT01427179|"~     The purpose of the research is to identify mutations (defects in the genetic blueprint) that~     cause spontaneous coronary artery dissection (SCAD), in other words, spontaneous tears in~     blood vessels that supply the heart.~      Some mutations may be inherited (passed on) from a parent without an apparent blood vessel~     problem while others may develop for the first time in the affected person.~   "
163390|NCT01427166|"~     To date, the scientific literature has yet to provide sufficient evidence regarding the~     pathophysiology of cording. The objective of this protocol is to evaluate the utility of non~     invasive vascular imaging for assessing the pathophysiology of cording in a small study~     cohort of patients who were treated for breast cancer. The hypothesis is that cording may~     have a vascular etiology~   "
163391|NCT01427153|"~     The purpose of this study is to compare an orthopaedic manual physical therapy (OMPT) to~     corticosteroid injection for the management of knee osteoarthritis.~   "
163392|NCT01427140|"~     The purpose of this study is to investigate the metabolic consequences of a moderate weight~     gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects~     in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight~     gain.~   "
163393|NCT01427127|"~     Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies~     reported that ramosetron is also effective treatment diarrhea-predominant irritable bowel~     syndrome. The investigators examine the effect of ramosetron used for preventing~     postoperative nausea and vomiting on bowel motility.~   "
163394|NCT01427114|"~     The purpose of this study is to determine how efficient the combination of rituximab,~     cyclophosphamide, vincristine, and prednisolone (R-CVP) is in the treatment of stage I or II~     non-conjunctival ocular adnexal MALT lymphoma (OAML).~   "
163395|NCT01427101|"~     The aim of this study was to compare debulking surgery and cytoreductive surgery in patients~     with Pseudomyxoma Peritonei with respect to efficacy and safety.~   "
163396|NCT01427088|"~     This study aims at investigating the neuroplastic potential and the possible factors~     affecting rehabilitation in chronic schizophrenia patients on stable medication, by~     investigating the cumulative pattern of serum BDNF representing the neuroplasticity in the~     brain, through quantitative stimulus such as rTMS.~   "
163397|NCT01427075|"~     This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for~     treatment of obstructive sleep apnea through MRI, before and 6 months after surgery.~   "
163398|NCT01427062|"~     Falling is a complex and most disabling feature for patients with Parkinson's disease (PD).~     Previous studies suggested that falls in patients with PD are related to postural instability~     characterized by deficits in anticipatory postural adjustment (APA) for postural orientation~     in walking and standing and inadequate postural response to perturbation. The present study~     developed an innovative balance treatment with focus of anticipatory and compensatory~     postural control and examined its effects on enhancing balance and gait performance and~     decreasing fall rate in people with PD.~   "
163399|NCT01427049|"~     Hypertension is a major and growing public health concern. Chronic elevation of sympathetic~     nervous system (SNS) activity has been identified as a major contributor to the complex~     pathophysiology of (essential) hypertension. The renal sympathetic nerves play a major role~     in the elevation of the SNS activity. Therapeutic renal denervation (RD), the deliberate~     disruption of the nerves connecting the kidneys with the central nervous system, has been~     shown to be an effective means of modulating elevated SNS activity - both by reducing the~     sympathetic modulation of renal function (renin release, sodium excretion and renal blood~     flow) and by removing the renal afferent sympathetic contribution to central blood pressure~     elevation.~      This current study is an observational exploratory study. The main objective of this study is~     to learn more on the effects of RD. We wish to do that by quantifying the effects of RD on~     various biological variables. Those variables are studied in four sets of investigations: a~     radiological set, a laboratorial set, a set of blood pressure measurements and a set of~     investigations in the vascular laboratory. The radiological set consists of imaging of the~     heart and kidney function (renal perfusion) and structure (renal arteries), the laboratorial~     set of serum and urine tests, 24 h- home- and office- blood pressure measurements will be~     taken and finally the set of vascular tests contains investigations on pulse wave~     velocity(PWV) and heart rate variability(HRV). The data will most likely help us to define~     future studies, to describe the mode of action and the effects of RD on various organs and~     systems in more detail, and finally to define in more detail which type of hypertensive~     patients is especially likely to benefit of the procedure.~      Hypothesis:~        -  We hypothesize that LV mass will decrease after RD. Because all patients have severe~          hypertension, it is likely that a substantial percentage will have increased LV mass.~        -  We hypothesize that renal perfusion and renal oxygenation increase after RD.~        -  We hypothesize that there will be no complications related to the device or procedure.~        -  We hypothesize that renal denervation has a beneficial effect on insulin resistance~        -  We hypothesize that renal denervation will decrease the blood pressure(office and~          24-hour-measurements)~        -  We hypothesize that RD has a beneficial effect on PWV and HRV.~   "
163400|NCT01427036|"~     Fractures of the trochanter in the elderly have a terrible prognosis both vital and~     functional. It is certainly possible to reduce the medical and economic impact of this~     disease by reducing surgical trauma, by means of minimally invasive osteosynthesis material~     adapted to this approach. This minimally invasive approach should, however, guarantee a~     result at least equal to the standard approach. The goal is to have a technique, easily to~     transmit, using a percutaneous approach, but which may be converted to conventional surgery~     in case of difficulty, and with implants appropriate for trochanteric fractures.~      With this in mind, the dynamic hip screw MISS® (Minimally Invasive Screw System) was~     developed and has already demonstrated its effectiveness in terms of anatomical results. It~     is as effective than the PHS® hip screw design for standard approach. The two implants have~     the same plate and screw and differ only by the system for fixing the screw on the plate to~     allow minimal invasive approach.~   "
163401|NCT01427023|"~     The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical~     swab, and cervical specimens collected in PreservCyt Solution (PreservCyt Specimens) for~     testing with the APTIMA Trichomonas vaginalis (ATV) Assay.~      These specimens will be used to demonstrate assay performance on the PANTHER System is~     comparable to performance on the TIGRIS System.~   "
163402|NCT01427010|"~     Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced~     toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This~     could also be of importance in IMRT for recurrent and second primary head and neck cancers in~     previously irradiated territory.~      This trial investigates the feasibility of continuous adaptive~     18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel ([18F]FDG-PET-voxel)~     intensity-based IMRT in reirradiation of patients with recurrent and second primary head and~     neck cancer.~   "
163403|NCT01426997|"~     To facilitate the development of a personalized approach to the treatment of patients with~     major depression, this study is designed to elaborate the clinical and neurobiological~     phenotype of depressed patients with increased inflammation. The data obtained in this~     proposal will allow the investigators to test the hypothesis that depression and inflammation~     interact to elaborate a relatively discreet phenotype that warrants an individualized~     approach to diagnosis and treatment of patients with depression. Moreover, the identification~     of specific environmental risk factors for inflammation will foster the elaboration of~     preventative strategies for patients at risk.~   "
163404|NCT01426984|"~     The study assesses the effect of Ritalin on working memory,attention,and decision-making~     measures in adults with BPD and compares it to its effect on healthy adults and adults with~     BPD (using data form study SHA 01-10), in a double-blind crossover design. The investigators~     hypothesize that Ritalin will result in better performance in all measures.~   "
163405|NCT01426971|"~     Primary Objective:~      - To compare the treatment groups in the reduction of pain score by at least 30 mm on a~     visual pain scale (VAS) at 60 minutes after study medication intake, compared to the baseline~     score (obtained before the study medication intake).~      Secondary Objectives:~        -  To assess the proportion of patients with more than 50% pain relief, according to the~          VAS score at 45 minutes after study medication intake compared to baseline~        -  Determine the following aspects in the timing of study medication intake:~             -  Time to the first perception of pain relief~             -  Time to onset of meaningful pain relief~             -  Reduction of pain at 15, 30, 45, 60, 120 and 240 minutes after study medication~               intake, to be evaluated as the difference between the scores on VAS in each period~               and baseline~        -  To assess the pain according to the five items of Headache Relief Rating - HRR (0:~          strong worsening 1: slight worsening 2: no change 3: slight improvement 4: strong~          improvement) at 15, 30, 45 and 60 minutes after study medication intake, according to~          the diaries completed by the patients~        -  To check the proportion of the patients requiring the third tablet of study medication~          within 24 hours of starting the study treatment and when it occurred~        -  To check the timing and frequency of rescue medication intake, as well as the proportion~          of patients who used these medications within 24 hours of starting the treatment~        -  Safety assessment.~   "
163406|NCT01426958|"~     To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of~     afatinib depending on the timepoint of ritonavir administration~   "
163407|NCT01426945|"~     RATIONALE: Studying tissue samples from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies protein expression in samples from young patients with~     rhabdomyosarcoma.~   "
163408|NCT01426932|"~     The alternate binaural bithermal caloric test (ABBT) is a well established examination in the~     evaluation of the dizzy patient. ABBT is useful in detecting the side of peripheral~     vestibulopathy by stimulating each ear separately, it contributes to the diagnosis of~     bilateral vestibular involvement when all responses to cold and warm stimuli are reduced, and~     adds to the differentiation of peripheral from central vestibular involvement by measuring~     the fixation-induced inhibition of the caloric response. In spite of these benefits, ABBT is~     the most time-consuming part of the electronystagmography/Videonystagmography (ENG/VNG) test~     battery, and frequently causes significant inconvenience to the patient due to the repeated~     extreme vestibular stimuli.~      The head impulse test (HIT) assesses vestibular function by brisk, passive rotations of the~     head in the plane of the examined semicircular canals. Whenever the vestibulo-ocular reflex~     (VOR) is deficient, this maneuver would produce catch-up saccades aiming to the re-fixation~     of the eyes on the target. Hence, both residual VOR and catch-up saccades act synergistically~     to stabilize gaze. The HIT requires only several minutes and might cause minimal discomfort~     only.~      The study hypothesis is that the HIT recorded by standard VNG equipment of the VNG system~     would provide diagnostic information on the side of vestibular involvement matching that of~     the ABBT.~   "
163409|NCT01426919|"~     The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP~     Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma~     Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to~     assist in determining the need for a CT scan of the head.~   "
163410|NCT01426906|"~     A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole~     or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male~     Volunteers.~   "
163411|NCT01426893|"~     The correct use of inhalation devices is an inclusion criterion for all studies comparing~     inhaled treatments. In real life, however, patients may make many errors with their usual~     inhalation device, which may negate the benefits observed in clinical trials. In real life,~     many errors seem to be made, but no wide-scale evaluation has been performed. The correct use~     of inhalation devices is essential to ensure the effectiveness of the treatment. It has been~     recently demonstrated that inhaler misuse is associated with decreased asthma control in~     asthmatics treated with an inhaled corticosteroid. The aim of our observational study was to~     evaluate the inhaler device usage in patients with asthma or chronic obstructive pulmonary~     disease (COPD).~   "
163412|NCT01426880|"~     Study participants with primary breast cancer will receive a standard chemotherapy with an~     anthracycline and a taxane as well as trastuzumab in case of HER2-positive tumors at doses~     and duration in concordance to current treatment guidelines. Patients will be receive and~     benefit in addition currently not in the neoadjuvant setting registered medication as~     lapatinib or bevacizumab of which significant increases of cure (pCR) rates have been~     reported in previous phase III studies. Patients randomized to carboplatin will receive in~     addition to the described backbone therapies a potentially active agent which suggested~     synergy of efficacy with chemotherapies as well as targeted agents. Patients might have the~     risk of an increase in toxicities due to the added agents and will have additional burden due~     to investigations required for study participation. However, due to the severity of the~     underlying disease and the high risk of relapse and death due to the stage of disease, this~     increase in toxicity and burden appears less relevant compared to the potential higher~     efficacy and finally cure rate by the incorporated treatments.~   "
163413|NCT01426867|"~     The purpose of this study was to describe the ocular discomfort immediately upon instillation~     of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1%~     Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with~     open-angle glaucoma and/or ocular hypertension.~   "
163414|NCT01426854|"~     The purpose of this study was to demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is~     superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular~     inflammation and pain associated with cataract surgery in Chinese subjects.~   "
163415|NCT01426841|"~     This study is intended to assess the feasibility of adjusting a radiation plan during its~     course to accommodate for a shrinking tumor target. The investigators hypothesize that an~     adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with~     chest-confined disease will allow for safe delivery of higher doses of chest RT than a~     non-adaptive RT planning approach without subjecting normal critical structures to~     unacceptable doses of radiotherapy.~   "
163416|NCT01426828|"~     This study will enroll myeloma subjects undergoing autotransplantation. The primary objective~     of this study is to evaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous~     lymphocytes mediate a more intense Id-specific immunity than non Id-KLH primed CD3/CD28~     activated autologous lymphocytes. There will be 2 arms in the study, one receiving a DLI with~     non Id-KLH vaccine and one receiving aDLI with Id-KLH vaccine.~   "
163426|NCT01426698|"~     The purpose of this study is to examine differences in the long-term effects of immediate~     versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22~     months corrected age.~   "
163427|NCT01426685|"~     The study will include 1200 patients with type 2 diabetes and angiographically documented~     coronary artery disease and 600 matched non-diabetic patients without type 2 diabetes.~     Extensive traditional and novel risk marker tests are performed for the patients and they~     will be followed-up for 5 years. Sudden cardiac death is the main outcome measure and various~     other endpoints are secondary endpoints. As a substudy, 120 diabetic patients and 120~     non-diabetic patients will undergo exercise training with home monitoring to assess the~     effects of exercise training on risk profiles.~   "
163428|NCT01426672|"~     PURPOSE:~      The purpose of this study is to quantitatively assess the efficacy of monovision correction~     in the treatment of acquired small angle binocular diplopia in adult patients.~      METHOD:~      Twenty patients with symptomatic diplopia were enrolled in a prospective treatment trial. All~     had stable deviations of 10 prism diopters or less for over three months. Each received~     monovision spectacles and/ or contact lenses with distance correction in the dominant eye.~     Half received a +3.00 diopter (D) add and the others received +2.50 D. The validated and~     standardized Diplopia Questionnaire and Amblyopia and Strabismus Questionnaire (ASQE) were~     used to quantify the efficacy of monovision correction for diplopia by measuring the~     functional impact on vision-specific quality of life.~   "
163417|NCT01426815|"~     In this Investigator Initiated study, the investigators want to explore the potential of an~     induction therapy with Tumor Necrosis Factor (TNF)-blocking agents in a very early disease~     stage (less than 3 months of symptom duration) of patients with predominant peripheral~     spondyloarthritis (SpA), classified according to the new Assessment of SpondyloArthritis~     (ASAS)-criteria. The hypothesis would be that treatment with a TNF-blocker at this early~     (immature) stage of the disease would result in a significant higher number of patients in~     clinical remission compared to placebo, and that - comparable to the early Rheumatoid~     Arthritis (RA) patients in the BeSt-study - long-term treatment would not be necessary to~     maintain this remission in a number of patients.~      In this placebo-controlled, double blind, randomized study (with open-label phase, starting~     at week 24) sixty patients fulfilling the Assessment of SpondyloArthritis (ASAS) criteria of~     peripheral spondylarthritis will be enrolled. Patients will be randomized in a 2:1 ratio (2~     golimumab :1 placebo). During the placebo-controlled phase, 50mg golimumab, or placebo will~     be administrated subcutaneously (SC) every 4 weeks through week 20. Subjects will be treated~     with open-label Golimumab 50 mg SC injections at weeks 24, 28, 32, 36, 40, 44, and 48. If~     patients are in 'clinical remission' (clinical remission is defined by the absence of~     arthritis, enthesitis and dactylitis clinically at two major consecutive visits. Visits are~     planned at week 12, week 24, week 36 and week 48) then the treatment will be stopped. In case~     of clinical relapse, patients will be treated with open-label golimumab 50 mg SC. Patients in~     sustained clinical remission will be observed to assess the possibility of maintaining~     drug-free remission. The study duration will be 48 weeks.~   "
163418|NCT01426802|"~     The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg~     bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.~   "
163419|NCT01426789|"~     This study aims to confirm if patients with a specific biomarker might have a better response~     to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done.~     The goals of these exploratory studies are to (1) find biomarkers that will identify persons~     with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to~     identify persons who will have fewer side effects in order to maximize their benefit from~     secukinumab.~   "
163420|NCT01426776|"~     Sleep disordered breathing, especially central sleep apnea, is common in patients with~     chronic heart failure. Heart valve replacement could have some effect on central sleep apnea.~     The aim of the study is to investigate effect of heart valve replacement on Cheyne-Stokes~     respiration in patients with rheumatic heart disease.~   "
163421|NCT01426763|"~     The objectives of the study are to:~        1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with~          recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE)~          who previously participated in CINRYZE Study 0624-200 (NCT01095497)~        2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered~          CINRYZE with rHuPH20~        3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of~          CINRYZE with rHuPH20~   "
163422|NCT01426750|"~     CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status~     of cancer patients, leading to nutritional support. The aim was to study enteral nutrition~     indications, as well as its compliance and the impact on nutritional status.~      DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year~     followed during anticancer therapy were included from January 2002 to January 2004. They~     received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a~     weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was~     observed, tube feeding with the same supplement (TFR) was indicated.~   "
163423|NCT01426737|"~     The purpose of this study is to explore long term glucose variability of a combination~     therapy of metformin and vildagliptin compared to a metformin - gliclazide combination.~      Multicenter, randomized, open, parallel group, Phase IV study, of 18 months duration.~        -  Trial with medicinal product~   "
163424|NCT01426724|"~     Active forms of vitamin D and its analogs are used to treat elevated parathyroid hormone~     levels and bone disease in chronic kidney disease (CKD). More recent animal and human studies~     suggest that treatment with vitamin D may be associated with reduction of inflammation and~     urinary protein loss as well as reduction the activity of the renin angiotensin system (RAS)~     in addition to its effects on the bone metabolism. The investigators of this study have used~     the new technique of contrast enhanced ultrasound (CEU) to measure the flow of blood to the~     kidney in other human studies. In this study, the investigators will investigate if 3 month~     of treatment with an active form of vitamin D in individuals with kidney disease and high~     parathyroid hormone levels would reduce protein loss in the urine. The investigators will~     also look at the potential changes in blood flow to the kidney using CEU, kidney function~     (GFR), inflammation and activity of RAS in response to treatment with active form of vitamin~     D. Finally, they will examine the association between reduction of protein loss in the urine~     as shown in other studies with any of the other factors measured (e.g, change in blood flow~     or inflammation).~   "
163425|NCT01426711|"~     The care of patients with sepsis and trauma requires the delivery of appropriate definitive~     care in the early stages of the illness. Hospitals with limited resources, those in rural and~     underserved areas of South Carolina, may be unable to consistently provide optimal care to~     these patients. In addition, the shortage of specialists nationally makes it more difficult~     for these hospitals to recruit and retain the specialists needed. Patients in these areas~     continue to pay the rural penalty of poorer outcomes. This study provides specialists' level~     care through telemedicine consults to rural emergency departments in rural areas of SC to~     improve outcomes for these patients.~      The CREST study is a project that specifically addresses the need to bring health care to~     rural communities in SC, as well as evaluates methods and tests technology to implement this~     care in rural communities. The CREST study uses telemedicine remotely from MUSC to rural~     community hospitals to provide rural community physicians care from specialists for trauma~     and sepsis, which are both high acuity, difficult to treat conditions.~      CREST is a multi-site trial of telemedicine services to meet rural patients' and providers'~     need for expert evaluation and management of sepsis and trauma. The specific aims of CREST~     are:~        1. To test the hypothesis that a telemedicine program including education and clinical~          consultation between a tertiary care academic medical center and rural, local hospitals~          will significantly improve key treatment decisions and outcome measures in sepsis and~          trauma.~        2. To test the hypothesis that the differences in ISS and time to antibiotics for trauma~          and sepsis patients exposed to telemedicine intervention and those without the~          intervention matched on propensity scores are not due to unmeasured confounders.~      CREST seeks new solutions to rural health disparities, to advance technology, create and~     retain jobs and address important research opportunities by combining implementation of a~     novel, trans disciplinary clinical program with rigorous, mixed methods scientific evaluation~     including clinical, process, and economic outcome measures. The impact on both science and~     quality healthcare outcomes is broad and CREST has far reaching implications for addressing~     rural health disparities for acute, life-threatening illnesses.~   "
163429|NCT01426659|"~     The preterm children have more difficulty minor neurological developmental than the general~     population even without cerebral palsy. Their oral language difficulties of language and~     writing have been little studied. The investigators propose to study spoken language has 3~     years 1/2 and stimulate or not (depending on randomization) children with phonological~     weaknesses notemment language. The investigators will evaluate stimulation protocol implied~     short and precise language in a re-education say and do in 20 sessions. A new evaluation of~     language (BILO and N-EEL), sensorimotor and cognitive constraints (KABC) will be performed at~     4 years.~      Early intervention on the basis of precise language before closing the window developmental~     (<5 years) is expected to improve as a result of language and cognitive development of~     preterm infants.~   "
163430|NCT01426646|"~     Although there has been some progress in chemotherapy for metastatic gastric cancer, no~     standard regimen of adjuvant chemotherapy is available, and many clinical trials have~     produced contradictory results. The majority of randomized clinical trials studying adjuvant~     chemotherapy in gastric cancer have been underpowered, involved low-volume centers, or used~     ineffective chemotherapy regimens. As a result, well-designed multicenter trials are still~     needed. The ACTS-GC trial, which demonstrated the efficacy of S-1 for stage II-III gastric~     cancer patients who underwent curative resection with extended lymph-node dissection (D2),~     may be valid in countries where D2 surgery is considered the standard of care. S-1 improved~     the 3-year overall survival from 70.1% for surgery alone to 80.1%. However, 3-year overall~     survival in stage IIIA and stage IIIB patients receiving S-1 were 77.4% and 63.4%,~     respectively, which are less satisfactory compared to the rate for stage II (90.7%). Based on~     the unsatisfactory outcome among later stage patients in the ACTS-GC adjuvant trial, further~     investigation is needed for more effective postoperative treatment of patients with stage~     IIIB and IV (M0) cancer. Therefore, the researchers investigated the efficacy and safety of~     S-1 versus S-1 plus cisplatin as adjuvant chemotherapy in patient with curatively resected~     gastric adenocarcinoma.~   "
163431|NCT01426633|"~     L-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and~     12 % leiomyosarcomas). Approval for the induction of trabectedin into the treatment~     armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with~     anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas~     (Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009). Significant activity has been~     described for the use of gemcitabine and especially the combination of gemcitabine and~     docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007). However, the combination of~     gemcitabine and docetaxel is associated with significant toxicity. Pulmonary toxicity and~     refractory peripheral oedema are the most common severe adverse events. The aim of the~     present phase I study will be to examine safety data of this promising treatment combination~     of gemcitabine and trabectedin in L-sarcomas.~   "
163432|NCT01426620|"~     This phase II trial will evaluate phyto-therapy's, in the form of blueberry powder,~     synergistic effect on second-line therapy for non-small cell lung cancer (NSCLC). The~     proposition is that the addition of blueberry polyphenolics to routine docetaxel therapy will~     have a significant, positive effect in the response rate and overall survival.~   "
163433|NCT01426607|"~     This is a randomized controlled study evaluating the impact of 2 months of oral appliance~     therapy on endothelial function in patients with severe obstructive sleep apnea syndrome~     intolerant to continuous positive airway pressure (CPAP) therapy.~   "
163434|NCT01426594|"~     This is a Phase 4, observational, open study in patients who their doctor has prescribe~     METPURE XL (S (-)metoprolol succinate)by clinical practice. No medication was provided by the~     sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an~     evaluation of baseline followed by information gathered from the assessment visits at week 4~     and week 8.~   "
163435|NCT01426581|"~     The purpose of this study is to evaluate the relative effectiveness of two different ways to~     teach subjects while hospitalized how to use respiratory inhalers and to follow-up after~     discharge home from the hospital to determine durability of the education.~      Teach-to-Goal (TTG) education employs instruction followed by patient teach-back, then~     repeated cycles of learning and assessment until a skill is mastered. By contrast, Brief~     Intervention (BI) education only consists of providing the patient with verbal and written~     instruction.~      The investigators hypothesize that hospital-based TTG compared to BI increases a patient's~     ability to retain instructions on respiratory inhaler technique. The investigators will test~     this hypothesis separately for the MDI and Diskus® devices after discharge.~   "
163436|NCT01426568|"~     The purpose of this study is to determine whether multi-convergent therapy is helpful to~     patients with inflammatory bowel disease who have functional abdominal symptoms or high~     perceived levels of psychological stress.~   "
163437|NCT01426555|"~     This is a research study to determine the effects of functional electrical stimulation (FES)~     rowing and a drug called zoledronic acid in bone health. The investigators hoped to learn if~     zoledronic acid treatment will increase bone mineral density in persons with chronic spinal~     cord injury (SCI) who received it. The investigators also want to find out if zoledronic acid~     is safe for persons with SCI to take without causing too many side effects.~   "
163438|NCT01426542|"~     Newborn babies with congenital heart disease often require surgery in the first month of~     life. The risks of brain damage from congenital heart disease and from the various corrective~     surgeries are high because of poor levels of oxygen reaching the brain. Topiramate is an~     anti-convulsant medication that protects brain cells from damage due to low amounts of oxygen~     in animal studies. The investigators hypothesize that giving topiramate to babies with~     congenital heart disease before and after surgery will decrease the amount of brain damage~     caused by the heart disease and/or the surgery to correct the heart disease.~   "
163439|NCT01426529|"~     Caveolin-1 and Vascular Dysfunction~      Thank you for your interest in the investigators Blood Pressure Research Study. The National~     Institutes of Health are sponsoring us to investigate why patients develop high blood~     pressure, atherosclerosis (hardening of the arteries), and heart disease. There are two parts~     of the investigators research program. The first part is a screening visit. At this visit you~     will be given a brief physical exam and will be asked questions concerning your medical~     history. During the same visit you will have your blood drawn for routine screening and~     genetic testing. You will also be asked to collect a urine sample for routine screening.~      If the doctor finds that you are a healthy candidate you will be invited to participate in~     the second part of the study. During Phase II, the investigators will perform physiological~     tests after you are placed on a low salt diet and again after you are placed on a higher salt~     diet. If you are on blood pressure medication, it may be necessary to discontinue taking your~     present medication for up to three months before beginning the study. Patients discontinuing~     their current blood pressure medication may be placed on a different blood pressure~     medication during this 'washout' period if necessary to maintain blood pressure at pre-study~     levels.~      Once your blood pressure medications are discontinued, you will be closely monitored. If you~     do not own a home blood pressure monitor, the investigators will provide one for you to use~     during the study so that you can keep a daily record of your blood pressure readings. The~     investigators will ask you to call us every three days to report your blood pressure~     readings. After you have stopped taking your medication, dieticians at the hospital will make~     you low salt meals to eat at home for about seven days. On the last day of the low salt diet,~     you will be asked to begin a 24-hour urine collection that you will bring with you when you~     are admitted to the hospital that evening. That morning, you will be required to come to the~     Center for Clinical Investigations (CCI) at Brigham and Women's Hospital for a one-hour test~     to check if your body is in the correct salt balance.~      You will return that evening to the CCI where you will be admitted for your study that will~     occur the next morning. On the morning of your low salt study, the investigators will collect~     some blood samples. The investigators will also take ultrasound pictures of your heart to see~     how salt and hormones affect the way your heart and blood vessels functions. These tests will~     last approximately 5 hours and you will be discharged around 2:00 PM. For the next 5-7 days,~     you will be placed on a high salt diet. During this diet period, you will eat all your own~     food, but the investigators will give you some supplements to add to your meals. After 5-7~     days on your high salt diet, on the morning of your second admission to the hospital, you~     will be asked to begin a final 24-hour urine collection. That morning, you will again be~     required to come to the CCI for a blood test, and you will return later that evening to the~     inpatient CCI where you will be admitted for your final overnight study. The same study that~     was done for the low salt diet will be repeated for the high salt study. You will be~     discharged at around 2:00 p.m. These studies will help to determine if you are~     salt-sensitive. In addition, the investigators hope to learn more about the hormones that~     regulate your blood pressure and the genes responsible for regulating those hormones.~      You will have the option to spend a second night in the CCI after each diet phase in order to~     participate in an optional study of the blood vessels in the arm. This study also uses an~     ultrasound machine. It will last about 2 hours in the morning.~      You will be placed back on your initial blood pressure medication (if you are on any) and~     returned to your regular physician for care. The investigators can also provide clinically~     relevant information to you.~   "
163452|NCT01426347|"~     The purpose of this study is to investigate the effect of vitamin D repletion on disease~     activity and disability in patients with rheumatoid arthritis.~      The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D~     deficiency have greater disease activity and disability, compared to RA patients with normal~     vitamin D levels. The investigators also hypothesize that vitamin D treatment in these~     deficient patients will result in a decrease in RA disease activity and disability.~   "
167402|NCT01374490|"~     This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg~     twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive~     (HIV+) subjects with diarrhea.~   "
163440|NCT01426516|"~     One-third or more of individuals treated for major depressive disorder (MDD) do not~     experience remission of symptoms despite at least two adequate antidepressant trials. Such~     treatment-resistant depression (TRD) contributes disproportionately to the tremendous costs~     of MDD, in terms of health care costs, functional impairment, and diminished quality of life.~      The promise of personalized medicine for individuals at high risk for TRD is apparent. If~     these individuals could be recognized early in their disease course, they could be triaged to~     more intensive or targeted interventions to improve their likelihood of remission. With the~     proliferation of treatment options in MDD, at present individuals can spend months or years~     in and out of treatment before receiving these next-step treatments.~      At present, no clinical or biomarker-based tool has been shown to assist in matching patients~     with treatments most likely to be effective for them. The Genecept Assay offers the~     possibility of Personalized Medicine in psychiatry. Clinicians may find this additional~     genetic information can lead to optimized treatment plans for individual patients. Before~     such an assay can be widely applied clinically, it is necessary to demonstrate that this tool~     usefully impacts treatment outcomes.~      This study will examine the potential impact of the assay in terms of depression severity at~     3 months, with further follow-up out to 6 months. Secondary measures will allow an estimate~     of its potential to change clinician behavior and improve patient quality of life. Further~     measures will also allow for refinement of the assay to maximize patient and clinician~     satisfaction, and estimate the potential savings associated with deployment of this assay in~     real-world clinical settings.~   "
163441|NCT01426490|"~     Vitamin B-6, folate and homocysteine may play a critical role in the colorectal cancer~     progression. This is a 4-y study and the specific aims are: 1) to compare vitamin B-6, folate~     and homocysteine status, oxidative stress, antioxidant activities and DNA methylation between~     subjects with colorectal polyps and colorectal cancer; 2) to study the effects of vitamin~     B-6, folate and homocysteine status on oxidative stress, antioxidant activities and DNA~     methylation in colorectal cancer patients; 3) to evaluate whether folic acid and/or~     pyridoxine supplementation had a beneficial effect on oxidative stress, antioxidant~     activities and DNA methylation in patients with colorectal; 4) to compare vitamin B-6, folate~     and homocysteine status, oxidative stress, antioxidant activities and DNA methylation between~     colorectal cancer patients and age-, sex-matched healthy subjects; 5) to evaluate the effect~     of vitamin B-6, folate and homocysteine status, oxidative stress, antioxidant activities and~     DNA methylation on the risk of colorectal cancer (odds ratio); 6) to follow the effects of~     vitamin B-6, folate and homocysteine status, oxidative stress, antioxidant activities and DNA~     methylation on the occurrence of colorectal cancer; 7) to follow the effects of pyridoxine~     and/or folic acid supplementation on the occurrence of colorectal cancer.~      This protocol is designed as a hospital-based cross-sectional, case-control, double blinded~     randomized placebo-controlled intervention and follow-up trial. Three hundred colorectal~     cancer patients and 300 age-, sex-matched controls who meet the inclusion criteria will be~     recruited from Taichung General Veterans Hospital. If cancer patients' plasma pyridoxal~     5'-phosphate (PLP) level less than 30 nmol/L will be asked to participate the intervention~     study and will be blinded and randomly assigned to either the 1) control (vitamin C, 100~     mg/d); 2) 50 mg vitamin B-6; 3) 400 microgram/d folic acid; or 4) vitamin B-6 (50 mg/d) plus~     folic acid (400 microgram/d) for 1 year. Data on demography, anthropometry, medical history,~     food frequency questionnaire and 24-h diet recall will be collected. Cancer patients will~     have fasting blood drawn before surgery or receiving chemotherapy. Additionally, fasting~     blood samples will be obtained at month 0, 3, 6, 9 and 12 during intervention period and at~     month 6, 12, 18, 24, 30, 36, 42 and 48 during follow-up. Hematological, plasma and~     erythrocyte PLP, plasma pyridoxal and 4-pyridoxic acid, serum and erythrocyte folate, serum~     vitamin B-12, homocysteine, SAM, SAH, lipid peroxidation indicators (TBARS, oxidized LDL),~     glutathione, antioxidant enzymatic activities and DNA methylation and MTHFR 677C>T~     polymorphism will be measured.~   "
163442|NCT01426477|"~     The main study objective is to determine the frequency of hernia recurrence following use of~     Veritas Collagen Matrix.~   "
163443|NCT01426464|"~     The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular~     pressure (IOP) utilizing an experimental lotion containing 0.005% Latanoprost that is applied~     to the outside of one eyelid.~   "
163444|NCT01426451|"~     The purpose of this study is to determine whether a drama workshop program for immigrant and~     refugee youth is effective in reducing impairment in high school students presenting learning~     difficulties.~   "
163445|NCT01426438|"~     This study is being done with people with HIV infection who have low levels of HDL-C. HDL-C~     is a type of good cholesterol. People with low HDL-C have a higher risk of heart disease~     and may have problems with how their blood vessels relax. The endothelium is the inner lining~     of all blood vessels, such as arteries and veins. When the endothelium is not working~     properly, the blood vessels have trouble expanding properly, which contributes to the~     development of heart and blood vessel disease.~      The main purpose of this study is to see if taking either extended-release niacin or~     fenofibrate for 24 weeks will help blood vessels work better by improving endothelial~     function and increasing HDL-C. Niacin and fenofibrate are medications that raise HDL-C. This~     study will also help determine how safe extended-release niacin and fenofibrate are.~      The analysis is an as-treated analysis of participants who completed study treatment and had~     a week 24 BART scan. Safety analyses include all participants~   "
163446|NCT01426425|"~     ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a~     prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational~     clinical study. The purpose of this clinical study is to demonstrate the safety and~     effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the~     conducting tissues of the heart in the treatment of patients with atrioventricular nodal~     reentrant tachycardia (AVNRT) using an endocardial approach.~   "
163447|NCT01426412|"~     This is a study in otherwise healthy Japanese and non-Japanese participants with elevated low~     density lipoprotein cholesterol (LDL-C). Following single doses of LY3015014, the safety and~     tolerability of the drug, how the body handles the drug, and the drug's effect on the body~     will be evaluated. Participants will remain in the study for approximately up to 6 months.~   "
163448|NCT01426399|"~     The objective of the study was to investigate the drug-drug interaction between LC15-0444 and~     metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy~     male subjets after oral administration concomitantly and each alone.~   "
163449|NCT01426386|"~     This trial investigates the effects of several doses of FE 999049 in women undergoing~     IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.~   "
163450|NCT01426373|"~     To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area~     (below the chin).~   "
163451|NCT01426360|"~     The objective of the present study was to compare the effects of a commercially available~     dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base, versus~     a control dentifrice, containing exactly the same ingredients apart from strontium chloride~     and potassium nitrate, on the instant and lasting relief of DH.~   "
163467|NCT01426139|"~     The objective of this clinical investigation is to assess the safety and clinical performance~     of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary~     artery lesions.~   "
163453|NCT01426334|"~     This phase I trial studies the side effects and the best way to give dasatinib and~     cyclosporine in treating patients with chronic myelogenous leukemia (CML) refractory or~     intolerant to imatinib mesylate. Dasatinib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Cyclosporine may help dasatinib work better by~     making cancer cells more sensitive to the drug. Giving dasatinib together with cyclosporine~     may be an effective treatment for CML.~   "
163454|NCT01426321|"~     For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a~     major improvement. The treatment improves symptoms and prolongs life in selected patients~     with heart failure. However, with the current selection criteria and methods for implanting~     the pacemaker, only 60-70% of the patients derive significant benefit from the treatment.~      New imaging techniques, including advanced ultrasound and computed tomography, in combination~     with new versatile multi-pole electrodes, have made an individually tailored therapy~     possible. Using these techniques in combination, the study will investigate the effect of~     individually based optimal placement of the pacemaker electrodes vs. standard care. The~     optimal LV electrode position is defined as pacing a viable segment with the latest~     mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac~     CT. The hypothesis is that this will increase the number of positive responders from 65% to~     85%.~   "
163455|NCT01426308|"~     The study will determine the performance of the Infinium HD Test.~        -  The primary objective of the study is to assess the performance of the Infinium HD Test~          using banked DNA samples extracted from whole blood patient samples derived from the~          intended use population.~        -  The secondary objective of the study is to determine the background number of~          chromosomal abnormalities per person in the general population based on the resolution~          of the Infinium HD Test.~   "
163456|NCT01426295|"~     The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in~     addition to standard oral care (strategy A) is cost-effective in the prevention and treatment~     of severe mucositis in adult patients with auto or allograft packaging without ICT versus~     mouthwashes standard bicarbonates with an antiseptic (strategy B).~   "
163457|NCT01426282|"~     The purpose of this study is to evaluate the effects of health education given by nurse on~     out-patient compliance in cardiovascular diseases prevention and treatment.~   "
163458|NCT01426269|"~     The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea~     during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen~     of Oracea® and MetroGel® 1%.~   "
163459|NCT01426256|"~     The purpose of this study is determine if high-dose vitamin D supplementation improves~     clinical outcomes related to lung function and immunity in patients with Cystic Fibrosis who~     are admitted to the hospital with an acute lung infection.~   "
163460|NCT01426243|"~     Main objective :~      To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever~     Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative~     individuals who had not been given YFV before.~      Secondary objectives :~        -  To develop and assess ELISPOT technology for yellow fever and to measure the response~          within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects~          and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy~          (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months)~          in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3)~          neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference~          method) and a new pseudotype based method, (4) post-vaccination viremia and (5)~          diversity of viral quasi-species.~        -  To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and~          viral load.~   "
163461|NCT01426230|"~     Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical~     practice~   "
163462|NCT01426204|"~     This is a Phase 4, descriptive, observational, open, prospective study of patients who their~     doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor.~     The planned observation time is 48 weeks and 24 weeks of follow-up.~      Each investigator participating in this registry will employ his or her discretion and~     standard clinical practice to determine when to see the patient in the clinic, how to manage~     the patient's drug regimen, and how best to monitor the patient's response and tolerance to~     therapy.~   "
163463|NCT01426191|"~     In the proposed study, the investigators plan to evaluate the efficacy and safety of~     Cefotaxime sodium and sulbactam sodium for injection (2:1)for the treatment of respiratory~     and urinary tract acute bacterial infection under the widely used in clinical conditions.~   "
163464|NCT01426178|"~     Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony~     reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support~     (PSV) mode.~      The purpose of the protocol is to compare asynchrony rate between periods of pressure support~     and periods of NAVA.~   "
163465|NCT01426165|"~     Hypomagnesemia (low magnesium) is an electrolyte imbalance commonly found in up to 65% of~     critically ill patients. Possible consequences of hypomagnesemia include neuromuscular and~     neurologic dysfunction, heart arrhythmias, and alterations in other electrolytes. Data has~     shown that critically ill patients with hypomagnesemia have a significantly higher mortality~     rate than patients with a normal magnesium level. The most simple and commonly used test to~     diagnose hypomagnesemia is a serum magnesium level. Based on the magnesium level and symptoms~     of hypomagnesemia, patients may be replaced with either oral or intravenous (IV) magnesium.~     When replacing magnesium via the IV route, approximately half of the dose is retained by the~     body while the remainder is excreted in the urine. The low retention rate is due to the slow~     uptake of magnesium by cells and decreased magnesium reabsorption by the kidneys in response~     to the delivery of a large concentration of magnesium. The purpose of this study is to~     determine whether an eight hour compared to a four hour infusion of IV magnesium sulfate~     results in a greater retention of the magnesium dose.~   "
163466|NCT01426152|"~     Progesterone levels measured in blood/serum of patients on the day of ovulation induction~     following controlled ovarian stimulation for in vitro fertilization may be associated with~     pregnancy outcome. The hypothesis is that higher progesterone levels are associated with~     lower implantation rates due to changes in the endometrial receptivity.~   "
163468|NCT01426126|"~     Taxane-based chemotherapy is currently one of the most commonly used regimen for salvage~     chemotherapy in advanced urothelial carcinoma. In previously untreated patients, single-agent~     paclitaxel, administered in a 24-hour infusion, produced an overall response rate of 42%, and~     single-agent docetaxel as a first-line therapy produced response rates of 31% and 45% in 11~     patients with impaired renal function. Of the two taxanes, paclitaxel has been studied more~     extensively.~      Intravenous administration of paclitaxel requires the use of solubilizing agents such as~     Cremophor EL (CrEL) due to its hydrophobicity. CrEL often contributes to hypersensitivity~     reactions including hypotension or dyspnea with bronchospasm, some of which are major and~     potentially life-threatening. Minor allergic reactions such as transient rashes and flushing~     also may occur. Despite pretreatment with corticosteroids and histamine antagonists, minor~     reactions still occur in 10-44% of all patients, with 1-3% of patients experiencing~     potentially fatal reactions. CrEL may also act as a potential cofactor for the development of~     peripheral neuropathy. In addition, special infusion sets must be used clinically when~     administering CrEL-based paclitaxel.~      Genexol-PM (Samyang Co., Seoul, Korea), a form of paclitaxel formulated with sterile,~     lyophilized polymeric micells that allow intravenous delivery of paclitaxel without CrEL. The~     polymeric micelle formulation is composed of hundreds of low molecular weight, nontoxic, and~     biodegradable amphiphilic diblock copolymers which include monomethoxy poly(ethylene~     glycol)-block-poly(D,L-lactide), and has a great potential in terms of water solubility, in~     vivo stability, and the nanoscopic size (a diameter of 20-50 nm) of the micellar structure.~      A phase I study established that Genexol-PM administered at 390 mg/m2 intravenously for 3 h~     every 3 weeks was the maximum tolerable dose (MTD) in humans. Dose-limiting toxicities were~     neuropathy, myalgia, and neutropenia. No hypersensitivity reactions were observed in any~     patients despite the absence of antiallergic premedication. The recommended dosage for phase~     II studies was 300 mg/m2.~      Based on the promising results of taxane-based chemotherapy and the absence of standard~     second-line chemotherapy regimen for advanced urothelial cancer, the investigators designed~     phase II study to explore the efficacy and safety of Genexol-PM in advanced urothelial~     patients, who previously treated with gemcitabine plus platinum as adjuvant chemotherapy or~     1st line therapy for metastatic diseases.~   "
163469|NCT01426113|"~     The purpose of this study is to assess the safety and efficacy of a new formulation of~     bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of~     paediatric patients with glaucoma.~   "
163470|NCT01426100|"~     The aim of the present study is to evaluate the efficacy and safety of two dose combination~     of Telmisartan/S-Amlodipine (40/2.5mg and 40/5mg) compared with telmisartan monotherapy~     (80mg) in hypertensive patients inadequately controlled by telmisartan monotherapy.~   "
163471|NCT01426087|"~     The main complications of cirrhosis are ascites, esophageal varices and hepatic~     encephalopathy. About 30% to 70% patients with cirrhosis occur esophageal varices, and the~     most common complication is ascites. Somatostatin is used to treat esophageal for a long~     time, otherwise it could aslo prevent ascites. In the study, the investigators explore the~     effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with~     esophageal gastric varices.~   "
163472|NCT01426074|"~     This study will determine the following: the response rate (including pathological CR rate),~     TTP, and complications of treatment in patients with rectal cancer treated with FOLFOX~     bevacizumab, the alteration of tumor blood flow (assessed by DCE-MRI as percentage change in~     Ktrans) after 1 cycle of bevacizumab therapy compared to baseline value in patients treated~     with FOLFOX alone and those treated with bevacizumab at 5 mg/kg., the degree of hypoxis~     (measured by tumor uptake of the 2-nitroimidazole EF5) induced by bevacizumab treatment and~     its relationship to changes in tumor blood flow, and the degree of apoptosis (measured by~     tumor uptake of di-annexin V) induced by bevacizumab treatment and its relationship to~     changes in tumor blood flow.~   "
163473|NCT01426061|"~     There is a lack of scientific evidence that homeopathy and reflexology is effective treatment~     of asthma. Systematic reviews have found that many clinical trials testing homeopathy and~     reflexology have major flaws, such as small number of participants, lack of control groups or~     inadequate allocation concealment.~      The aim of the present study was to assess the effect of reflexology and individualised~     homeopathy as an adjuvant treatment in asthma. In order to address this issue, the~     investigators conducted an investigator-blinded, randomized, controlled parallel group study.~   "
163474|NCT01426048|"~     A follow-up study of 191 patients operated on with the TVT procedure between January 1998 and~     May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital. After a~     mean of 10.5 years patients were invited to a follow-up visit. Subjective outcome was~     evaluated with condition-specific and general quality of life and health questionnaires.~     Objective outcome was evaluated with gynaecological examination and a supine stress test.~     Objective cure was defined as a negative stress test and no need for a reoperation for SUI~     and subjective cure.~   "
163475|NCT01426035|"~     Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream~     in the treatment of superficial varicose veins~   "
163476|NCT01426022|"~     Rationale: Food choice is influenced by postprandial mood; the feelings of well-being after a~     meal. Postprandial mood can be measured by subjective responses. Physiological responses may~     play an important role in the generation of postprandial mood. However, the relationship~     between subjective and physiological responses after a meal is not clear yet. To investigate~     this relationship, moderate alcohol consumption will be used as a mood modulator, because of~     its well-studied effects on mood. Postprandial mood depends on the current mood state.~     Therefore the investigators will manipulate the current mood state by changing the ambiance~     to measure the influence of moderate alcohol consumption with a meal on postprandial mood in~     a pleasant or unpleasant ambiance.~      Objective: To determine whether moderate alcohol consumption with a meal in different~     ambiances affects postprandial mood, evaluated by subjective and physiological parameters.~      Study design: Randomized, placebo-controlled, single-blind, cross-over trial~      Study population: 28 apparently healthy, normal weight (BMI 18.5-27 kg/m2) women (18-45 y),~     taking oral contraceptives.~      Intervention: 4 times having dinner at TNO Zeist with either 3 glasses of sparkling white~     wine (~30g alcohol) or alcohol-free sparkling white wine in either a pleasant or unpleasant~     meal ambiance.~      Hypothesis: It is hypothesized that moderate alcohol consumption with a meal in different~     ambiances changes the response of subjective and physiological parameters of mood.~        -  Ho: there is no effect of alcohol consumption and ambiance on mood~        -  H1: there is an effect of alcohol consumption and ambiance on mood~   "
163477|NCT01426009|"~     The purpose of this study is to determine steady-state efficacy and dose response profile and~     to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing~     using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two~     active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease~     (COPD).~   "
163875|NCT01420822|"~     This post-marketing surveillance study is to investigate possible problems or questions in~     safety and efficacy of ALLERMIST Nasal Spray for long-term use in Japanese subjects with~     allergic rhinitis under the conditions of actual practical use.~   "
163478|NCT01425996|"~     Radiotherapy (R/T) for locally advanced hepatocellular carcinoma (HCC) is often used in~     patient who is not suitable for transarterial chemoembolization (TACE) and other local~     therapy, especially in those with portal vein tumor thrombosis (PVTT) caused by tumor cells.~     Several previous studies have showed that local R/T is tolerable and can induce a substantial~     tumor response in HCC management. In addition, the safety, toxicity and preliminary efficacy~     of Lipotecan® (TLC388) has also been proved in patients with terminal malignancy. This study~     aims to evaluate the safety, tolerability and efficacy of concomitant Lipotecan® and~     radiotherapy in patients with locally advanced HCC and PVTT.~   "
163479|NCT01425983|"~     Psychosocial stress leads to altered neuroendocrine functions, such as serotonergic~     dysfunction, as well as alterations of the autonomic nervous system and the~     hypothalamic-pituitary-adrenal (HPA) axis activity resulting in an imbalance between~     inhibitory and excitatory neurotransmitters. Clinical consequences include, inter alia,~     neurovegetative disorders, higher resting heart rate, hypertension, depressive symptoms,~     sleep disturbances, irregular body-weight changes, and insulin resistance. Poor dietary~     intake of the essential amino acid L-tryptophane as a precursor to 5-hydroxytryptamine (HT,~     serotonin) increases sensitivity to stress.~      It is therefore the investigators hypothesis that daily oral administration of an amino acid~     mixture (dosage 3.8 g/day) with micronutrients specifically designed to decrease~     neurovegetative disorders will target these neuroendocrine and metabolic alterations in~     adults with psychosocial stress. The principal endpoints will be a decrease in points in the~     psychological-neurological questionnaire (PNF).~   "
163480|NCT01425970|"~     Part A: The purpose of this study is to evaluate the safety and tolerability of INX-08189 and~     placebo with Peginterferon alfa-2a and Ribavirin during 12 weeks of treatment~      Part B: The purpose of this study is to evaluate the safety and tolerability of INX-08189~     with Ribavirin or INX-08189 with Daclatasvir or INX-08189 with Daclatasvir and Ribavirin~   "
163481|NCT01425957|"~     THE STUDY WILL BE A TWO-PART RESEARCH~      PART A and PART A extended:~        1. To implement a common MRI acquisition protocol in multiple centers across Europe~          (Pharma-COG partners).~        2. Apply the common MRI protocol on phantoms and human subjects to characterize, compare~          and minimize test-retest variability across the MR sites of WP5 for all the quantitative~          metrics that will be later assessed on patients.~      PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and~     neurophysiological data in Mild Cognitive Impairment patient, we aim to:~        1. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)~          which is more sensitive than the changes observed in the loss of hippocampal volume~          (primary endpoint) and correlate with the neuropsychological progression and conversion~          (clinical secondary endpoints).~        2. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)~          at baseline which is more predictive of the loss of hippocampal volume (primary~          endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI~          patients.~        3. To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe~   "
163482|NCT01425944|"~     This study has three aims that hope to expand the knowledge on the cause of Sturge-Weber~     Syndrome (SWS) and improve clinical care of Sturge-Weber Syndrome patients.~   "
163483|NCT01425931|"~     O2C is a diagnostic device for non-invasive determination of oxygen supply in~     microcirculation of blood perfused tissues. The optical sensor is easy to handle and~     guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as~     in research. The examinations are without any strain for your patient.~      Determines by use of a glass fibre probe:~      Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of~     Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen~     supply of organs and tissue.~      With it is possible to measure locally the amount of oxygen which is transported into the~     region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is~     monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical~     sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and~     subsequently to organ failure, now can be detected in an early state by use of the new sensor~     system.~      One of these new developed sensors are used to place in rectal position during extracorporeal~     circulation to determine the microcirculation.~   "
163484|NCT01425918|"~     Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD)~     social deficits and studying the efficacy of this intervention, the investigators hope to~     provide a means for children with ASD to more effectively and efficiently process social~     information and enable them to more successfully engage in social interactions. Children~     between the ages of 24 and 36 months and their families may join.~   "
163485|NCT01425905|"~     Background:~      Type 2 diabetes is a chronic disease that puts individuals at risk for serious health~     problems like heart disease, kidney failure, vision problems, and stroke. A major way that~     type 2 diabetes occurs is through insulin resistance. Insulin resistance means that insulin~     (an important hormone in the body to keep blood sugar normal) isn t working as well as it~     should, which can lead to problems with high blood sugar. Insulin resistance has been linked~     to mood problems, stress, and depression, especially in women. To determine if group programs~     can help reduce the risk for type 2 diabetes, researchers want to look at teenage girls who~     are at risk for developing the disease.~      Objectives:~      To test whether a group program designed to improve mood also can help improve insulin~     resistance in teenage girls who are at risk for developing type 2 diabetes, or whether a~     group program that teaches healthy living skills is just as helpful.~      Eligibility:~      Teenage girls between 12 and 17 years of age who are at risk for developing type 2 diabetes.~      Design:~        -  Participants will have two screening visits to find out if they are eligible to take~          part in the study. The first visit takes about 3 hours and will involve a physical exam,~          medical history, questionnaires and an interview about mood problems and possible~          depression. The second visit takes about 6 hours and will involve a full body scan to~          measure muscle and fat, blood draws and a glucose test to determine insulin resistance,~          questionnaires about general well-being and eating habits, eating meals and snacks, and~          an exercise test.~        -  Participants will join one of two group programs at the National Institutes of Health.~          One group focuses on learning skills to help with bad moods and stress. The other group~          covers topics that are important for teens to lead a healthy life. The groups will meet~          for 1 hour once a week for 6 weeks during after-school hours.~        -  At the end of the groups, participants will have three follow-up visits. The first visit~          will be 6 weeks later, the second will be 6 months after the start of the group program,~          and the third will be 1 year after the start of the group program. Each visit will take~          about 6 hours. These visits are similar to the second screening visit before the groups.~        -  Some participants will have extra tests to study stress at the second screening visit~          and the 6-week, 6-month, and 12-month follow-up visits. Participants will give samples~          of DNA, saliva to measure stress hormones, and they will take part in a brief stress~          test.~      For more information, visit the study website at: http://mir.nichd.nih.gov or contact the~     research coordinators for the study at 301-594-3198.~   "
163521|NCT01425437|"~     Much progress in treatment of various tumors has been made in the laboratory and the results~     have been brought back to the patients, i.e. from bench to bedside. This trial intends to~     collect samples of keloid tissue from patients and study them in laboratory. Such a research~     may help us with finding better treatments for keloid.~   "
163486|NCT01425892|"~     Background:~      -Sjogren s syndrome is a disease that affects about 1-4 million Americans. It is more common~     in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes and~     dry mouth. The cause of Sjogren s syndrome is unknown, but inflammation plays an important~     role. The purpose of this study is to learn more about Sjogren s syndrome.~      Objectives:~      -To better understand how Sjogren s syndrome begins and how it affects patients so that we~     can develop better ways to treat them.~      Eligibility:~        -  Participants must be 16 years of age or older.~        -  They must have a diagnosis of Sjogren s syndrome or have at least two symptoms of~          Sjogren s syndrome.~      Design:~        -  People taking part in the study will come to the NIH Clinical Center for at least three~          visits.~        -  During these visits, participants will have a medical history and physical exam. They~          will have oral and dental assessments, and saliva collection. Lab tests (blood and~          urine) and dry eye exams will be done. Participants will answer questionnaires and have~          salivary scintigraphy (adults only unless required for diagnosis).~        -  Other optional tests may also be done. Participants may have to come in for additional~          visits if they have these optional tests or if their disease changes.~        -  The only treatment provided as part of this study is for medical emergencies or~          complications that occur while you are at NIH for evaluation....~   "
163487|NCT01425879|"~     This phase II trial is studying how well MD2206 works in treating patients with advanced~     refractory biliary cancer that cannot be removed by surgery.~   "
163488|NCT01425866|"~     Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical~     trials have clearly demonstrated that a better control of blood glucose level and of other~     risk factors is efficient in preventing or retarding the complications of the disease. On~     Reunion island, Type 2 diabetes is present in 18% of population aged 30 or older with a high~     level of socio-economic deprivation. The hypothesis of the ERMIES study is that a structured~     group self-management education maintained at the community level for 2 years in patients~     with insufficiently controlled type 2 diabetes has better metabolic results (as attested by~     improvement in HbA1c level) at 2 yrs, compared to an initial short term (< 3 months)~     self-management program, based on the same theoretical basis and framework (learning nests~     empowerment). A total of 240 adults living in Reunion Island, with type 2 diabetes mellitus~     with HbA1c ≥ 7.5% on a stable treatment for at least 3 months will be randomly allocated to 2~     intervention arms: either a short term (< 3 months) program (1 to 7 thematic 2-hr long~     sessions depending on individual assessment), or a long term program including the same~     initial program as 1st arm, but with group self management education sessions, maintained for~     2 years (4-monthly assessment, empowerment, and contextual action planning; facultative~     additional specific thematic sessions being delivered if needed). Medical visits will be held~     quarterly for the recording of outcome measures (HbA1c, blood pressure, anthropometrics,~     tobacco consumption, diabetes complications) and yearly for blood glucose, lipids,~     micro-albuminuria or proteinuria, creatinine clearance, diet and exercise (questionnaires),~     treatment recording, quality of life, self-efficacy, anxiety and depression scales, and~     social support.~   "
163489|NCT01425853|"~     The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS)~     and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of~     patients with moderate to severe knee osteoarthritis (OA).~   "
163490|NCT01425840|"~     This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated~     lidocaine on oral mucosa.~   "
163491|NCT01425827|"~     Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis~     worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options~     have had limited symptomatic effect and are associated with significant side effects.~     Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to~     have, besides its antidepressant properties, a centrally acting analgesic effect.~      The aim of the present study was to investigate the efficacy of duloxetine in reducing pain~     in older adults with knee OA.~      288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary~     knee OA attending the outpatient clinic of our institution were enrolled in this study. All~     patients underwent a physical examination and where questioned about the number of flares.~     Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid~     obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of~     duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The~     primary outcome measure was pain reduction. Secondary outcome measures included improvements~     in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and~     Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported~     physical function as measured with the Western Ontario and McMaster Universities~     Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression~     Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded.~     Safety and tolerability were also assessed. Data was collected at baseline and at monthly~     intervals for 4 months. All staff involved in data collection was blinded to the treatment~     assignment groups.~   "
163492|NCT01425814|"~     The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single~     doses of inhaled LAS100977 in COPD patients.~   "
163493|NCT01425801|"~     The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled~     LAS100977 QD in patients with persistent asthma.~   "
163494|NCT01425788|"~     The purpose of this trial is to investigate the tolerability of Osiris Phleum pratense used~     with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current~     practice.~   "
163514|NCT01425528|"~     The purpose of this study is to identify the dose of Kuvan needed to normalize the levels of~     tetrahydrobiopterin (BH4) in patients with a Guanosine Triphosphate Cyclohydrolase (GTPCH)~     deficiency and to asses the potential impact of oral Kuvan on mood and function in~     individuals with GTPCH deficiency who may be experiencing symptoms of anxiety, depression,~     fatigue, trouble concentrating, or memory loss. This will be a phase one study. The~     investigators will monitor patients over a period of three to six months while on the~     medication. Medication levels will be monitored by measuring the BH4 levels in cerebral~     spinal fluid (CSF). Patients will undergo a baseline lumbar puncture and two follow-up lumbar~     punctures for this purpose. The investigators will also monitor emotional function and motor~     function.~   "
163495|NCT01425775|"~     Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune disease.~     Vitamin D has potent immunomodulatory properties that have promoted its potential use in the~     treatment of autoimmune conditions, including SLE. We assessed vitamin D status in SLE~     patients and determined alterations in inflammatory, hemostatic markers as well as disease~     activity before and after vitamin D supplementation.~      248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were~     randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months.~     Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18,~     TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12~     months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were~     measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were~     classified as vitamin D insufficiency, and levels < 10 ng/ml as vitamin D deficiency.The mean~     25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.~   "
163496|NCT01425762|"~     This is a randomized controlled study that will place patients into a choice and a no~     choice group. The choice group will be able to choose between receiving 100 mcg or 200 mcg~     intrathecal morphine. The no choice group will be randomized to receive either 100 mcg or 200~     mcg of intrathecal morphine. Following casarean delivery, pain scores will be measured at 3,~     6, 12, 24, and 36 hours.~   "
163497|NCT01425749|"~     The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined~     with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer~     Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites,~     intramuscular (IM) or intradermal/subcutaneous (ID/SC), and 2) to provide preliminary data on~     the immunological response to ASCI in the injection site microenvironment, in the node~     draining the vaccine site (sentinel immunized node) and in the blood and whether there are~     large differences in the magnitude, persistence, or type of immune response induced as a~     function of the ASCI injection. Evaluation of immune responses to the ASCI will include,~     amonth others antiMAGE-A3 antibody responses and CD4+ and CD8+ T cell responses.~   "
163498|NCT01425736|"~     Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR). In phase II~     clinical trials a combination of Nimotuzumab with chemotherapy or radiation therapy achieved~     satisfactory therapeutic outcomes in patients with advanced squamous cell carcinoma of head~     and neck, or glioblastoma. We therefore postulated that Nimotuzumab in combination with~     conventional definitive chemotherapy might improve the rate of disease control (RDC),~     progression-free survival (PFS),and overall survival in patients with recurrent and/or~     metastatic SCCHN , which is a poor-prognosis patient population for whom there is currently~     no standard treatment approach, we designed this trial to test this hypothesis.~   "
163499|NCT01425723|"~     The primary objective of the study is to evaluate the long-term safety of rFIXFc in~     participants with hemophillia B.~      The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention~     and treatment of bleeding episodes.~   "
163500|NCT01425710|"~     Non-invasive measurements of cardiac output (CO), systemic vascular resistance (SVR),~     corrected aortic flow time (FTc) and stroke volume (SV) are useful parameters during~     laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative~     changes in volume status and to estimate the volume depletion.~   "
163501|NCT01425697|"~     The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site~     infections in patients having elective cardiac surgery.~   "
163502|NCT01425684|"~     The principle aim of the project is to identify the key brain circuits associated with~     smoking and especially smoking in high risk population. The investigators hope that the study~     will provide concrete biomarkers for new therapeutic development and ultimately reducing the~     smoking related health burden.~   "
163503|NCT01425671|"~     The principle aim of the project is to analyze brain electrical activity and genetic~     information that will help identify the nature and cause of the disease schizophrenia. This~     effort should lay the groundwork for future treatment in schizophrenic patients.~   "
163504|NCT01425658|"~     Objective :To compare the analgesic effect of intrathecal clonidine and fentanyl as an~     additive to bupivacaine in patients undergoing cesarean section .~      Methods:Following Ethics Committee approval and informed patients consent, Ninety patients~     18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal~     anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were~     randomly allocated to one of three groups of 30 each. The clonidine group (groupC) received~     bupivacaine 10mg combined with 75microgram clonidine preservative free ,the fentanyl group~     (group F) received bupivacaine 10mg combined with25microgram fentanyl and the placebo group~     (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time~     to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level~     , onset of motor block, duration of blockade, hemodynamics variables, the incidence of~     hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen~     (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation,~     dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were~     instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain,~     10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient~     requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for~     post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of~     administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.~   "
163515|NCT01425515|"~     The investigators are conducting a single group intervention study to improve blood pressure~     control and reduce racial and literacy related disparities among people with hypertension.~     The intervention includes providing patients with home blood pressure monitors, administering~     phone-coaching to participants, and improving hypertension care at the participating~     practices from which patients are enrolled. The investigators will follow the patients for 2~     years to determine if blood pressure control improves. In addition, the project will explore~     genetic factors associated with cardiovascular disease risk and treatment success.~   "
163516|NCT01425502|"~     A cluster randomised controlled trial to test the effectiveness of an informatics tool,~     educational and financial incentives to reduce high risk prescribing of non-steroidal~     anti-inflammatory drugs and anti-platelet agents.~   "
163505|NCT01425645|"~     No evidence-based, evaluated, population-appropriate resources exist to translate Type 2~     diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such~     large-scale interventions include:~        -  the need to identify, then target specific at-risk populations~        -  significant time-delays before any program effects on T2DM incidence may manifest.~      However, women with gestational diabetes (GDM) are a readily identifiable study cohort at~     significant risk for recurrent GDM and T2DM—hence GDM women provide important opportunities~     for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD~     (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely targeting~     women with recent GDM in the context of their families.~      FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with~     recent GDM, within their family context. Five Canadian sites and 177 women will participate.~     Multifaceted information and behavioural change support will be provided for diet, weight~     loss, and activity through: seminar, walking groups, electronic updates, password-protected~     social networking site.~      Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices;~     HbA1C; body habitus at study onset/during study/12 months/24 months.~      Consenting immediate family members will have protective knowledge/diet/exercise choices/body~     habitus measures documented at study onset/12 and 24 months.~   "
163506|NCT01425632|"~     The objectives of this study are: to confirm the superiority of TAU-284 over placebo after~     two weeks of administration to pediatric patients with perennial allergic rhinitis, and to~     investigate the dose response, safety, and plasma concentrations of TAU-284.~   "
163507|NCT01425619|"~     Allergy skin tests are occasionally associated with pain and anxiety in patients undergoing~     this procedure. The investigators intend to examine if medical clowns compared with local~     anesthetic cream can decrease these feelings in children.~   "
163508|NCT01425606|"~     Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by~     using the stewart approach to acid - base interpretation, would like to show that the~     positive charged m- proteins produced in m.m.result in true hyponatremia.~   "
163509|NCT01425593|"~     Chronic idiopathic urticaria (CIU) is a common form of chronic urticaria in which the cause~     is not detected after intensive clinical and laboratory investigation.In view of the current~     data, it was suggested that at least part of the patients with CIU have an autoimmune~     process.This study is designed to investigate the mechanisms involved in the regulation and~     activation of the immune cells in patients with CIU and corelate them with disease activity~   "
163510|NCT01425580|"~     Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin with insulinotropic~     properties. Apart from the glycemic actions, cardiovascular effects by GLP-1 have recently~     been reviewed. Receptors for GLP-1 are expressed in the rodent and human heart and acute~     activation of GLP-1 signalling has been shown to influence e.g. heart rate and blood~     pressure. In a knock-out mouse model, GLP-1R-/- mice exhibited a defective cardiovascular~     contractile response together with left ventricular hypertrophy. GLP-1 improves severe left~     ventricular heart failure in humans suffering from a myocardial infarction. Hence, it has~     been demonstrated that GLP-1 exerts direct functional effects through both GLP-1 receptor~     dependent and independent pathways in the heart.~      Native GLP-1 is an extremely short acting peptide, with a half-time breakdown of 1-2 minutes,~     a feature that makes it unsuitable as a drug treatment for type 2 diabetes. To this end,~     several long-acting GLP-1 analogues, drugs for treating type 2 diabetes, have been tested for~     this purpose. The analogue liraglutide exerts its effects via the native GLP-1 receptor,~     localized not only on the pancreatic β-cells, but also in the human heart. Interestingly,~     liraglutide has been demonstrated to have beneficial effect on heart function in mice. Taken~     together, recent data shows that GLP-1 and its stable analogue liraglutide exert beneficial~     cardiovascular effects.~      The purpose of this study is to determine whether the glucagon-like peptide-1 (GLP-1)~     analogue liraglutide improves heart function (measured as left ventricle longitudinal~     function and/or functional reserve during rest and/or after exercise) after 18 weeks of~     liraglutide + metformin, compared with glimepiride + metformin, using tissue Doppler~     echocardiography.~   "
163511|NCT01425567|"~     If a child is unable to tolerate enough of his/her feeding orally to grow and requires that~     nutrition is given by vein (IV parenteral nutrition), it can result in severe liver disease.~     This is called cholestasis. IV fat that children receive may be contributing to this liver~     disease. A different fat mixture comprised from fish oil could be used in place of~     intralipid. This is a compassionate use of the fish oil and not a comparison of the two. We~     believe the use of fish oil may provide less liver disease and decrease the need of liver~     transplant or dying than those who receive the usual fat.~   "
163512|NCT01425554|"~     This study is aimed at evaluation of diagnostic value of Doppler sonography, MR venography~     and air-plethysmography for the assessment of abnormalities in the internal jugular veins,~     with catheter venography as the reference test.~   "
163513|NCT01425541|"~     Girls with high levels of the male hormone testosterone often develop polycystic ovary~     syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess~     facial and body hair, and weight gain. Women with PCOS also have difficulty becoming~     pregnant. Some, girls with high levels of male hormone will develop normal hormone levels as~     they grow up. Most girls continue to have high levels of male hormone as adults. In addition,~     girls with elevated levels of male hormones often have lower fertility rates in adulthood. In~     this study the investigators will aim to discover the effect of 7 days of estrogen and~     progesterone on GnRH pulses in girls and women with the goal of understanding how and why~     some girls and women have higher levels of male hormone and the causes of PCOS. If~     investigators understand the causes of these disorders, they may be able to better treat them~     and perhaps even learn how to prevent the development of PCOS.~   "
163517|NCT01425489|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Krabbe~     Disease from plasma~   "
163518|NCT01425476|"~     This is a biomarker study with the goal of measuring changes in proteins and gene~     methylation. This study is not intended for use in diagnosing, mitigating, treating, curing,~     or preventing disease.~      The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in~     combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), to~     decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of~     breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.~   "
163522|NCT01425424|"~     This randomized, double-blind, placebo-controlled, multi-site study is to reverse modest~     elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension)~     or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D.~     This may reduce the chances of developing diabetes or high blood pressure or both later in~     life.~   "
163523|NCT01425411|"~     The study hypothesis: Valsartan as an angiotensin II receptor blocker treatment has~     beneficial effects on both midwall mechanics and myocardial functions in hypertensive~     patients with Left ventricular hypertrophy.~   "
163524|NCT01425398|"~     High-dose statin therapy around the time of surgery, decreases inflammation in patients~     undergoing cardiac valve surgery, and thereby improves clinical outcomes.~   "
163525|NCT01425385|"~     Patients with liver failure undergoing liver transplantation often have clinical or~     sub-clinical encephalopathy that may lead to increased intracranial pressure. The latter may~     lead to abnormal regulation of blood flow to the brain (cerebral autoregulation) complicating~     patient management during and after general anesthesia. The current methods for monitoring~     for elevated intracranial pressure are invasive and, thus, limited to severe encephalopathy.~     In this study the investigators will evaluate the potential utility of monitoring cerebral~     blood flow (CBF) autoregulation non-invasively using near infra-red spectroscopy in patients~     undergoing liver transplantation.~   "
163526|NCT01425372|"~     Streptococcus pneumoniae is a major cause of serious bacterial infections, particularly among~     young children. Over 30 different types of the pneumococcus germ can cause invasive disease,~     but 7 types (namely serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) are responsible for around 75%~     of cases in young children. A pneumococcal conjugate vaccine against these 7 serotypes (PCV7;~     Prevenar ®, Wyeth Vaccines) was introduced into the UK national immunisation programme in~     September 2006 and has resulted in a rapid reduction in pneumococcal disease caused by the 7~     serotypes among both vaccinated children and older unvaccinated children and adults through~     herd immunity. By 2009, over half of all invasive pneumococcal cases in young children were~     caused by six other pneumococcal serotypes (1, 3, 5, 6A, 7F and 19A) that are included in a~     newly licensed 13 valent pneumococcal vaccine (PCV13; Prevenar 13®, Wyeth Vaccines). In April~     2010, PCV13 replaced PCV7 in the UK immunisation programme with the aim of further reducing~     cases of invasive pneumococcal disease. The antibody responses induced by the 7 serotypes in~     both PCV13 and PCV7 have been shown to be comparable, but the protection offered by the~     additional 6 serotypes in PCV13 merits further study. Also, it is possible that the use of~     PCV13 instead of PCV7 may interfere with immune responses to other vaccines, such as~     Haemophilus influenzae serotype b (Hib), which are given to infants at the same time as~     PCV13. The proposed study will aim to collect one blood sample from infants after they~     receive their routine vaccinations at 2, 3 and 4 months in order to their measure immune~     responses to routine vaccines. The investigators hope that their results will help us better~     understand the added protection offered by the 13valent pneumococcal vaccine and ensure that~     children are adequately protected by the other vaccines they receive.~   "
163527|NCT01425359|"~     This study will evaluate the effect of ranolazine compared to placebo on the average weekly~     angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who~     have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the~     frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to~     record their daily angina episodes in a diary at the end of each study day. Ranolazine is~     approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.~   "
163528|NCT01425346|"~     The goal of this study is to measure lens fluorescence in normal subjects at various~     chronological ages that could serves as a guide to clinicians in determining changes in eye~     health. A measure of lens fluorescence can be used by clinicians as an indication of~     degenerative changes occurring in the lens of the eye.~   "
163529|NCT01425333|"~     The aim of this study is to assess which of two commonly used surgical procedures in the~     treatment of ovarian cysts called endometriomas (cutting out of the cyst - cystectomy, or~     draining it and cauterising it's inner lining - ablation) causes the least damage to the~     ovary and is therefore best at maintaining the future fertility potential of a patient.~   "
163530|NCT01425320|"~     This study will investigate the pharmacokinetics, safety and tolerability of dapsone and~     adapalene following topical administration of 2 formulations of dapsone/adapalene fixed~     combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects~     with acne vulgaris.~   "
163531|NCT01425307|"~     The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy~     (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell~     anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently~     receive chronic transfusions to reduce the risk of primary stroke. For the alternative~     treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen~     (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must~     have a mean TCD velocity similar to that observed with transfusion prophylaxis.~   "
163532|NCT01425294|"~     This study is a post-authorisation study, committed to Center for Drug Evaluation (CDE) and~     China Food and Drug Administration (CFDA), in order to provide more effectiveness and safety~     data about Faslodex in real world clinical practice in China. The primary objective of this~     study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal~     women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for~     disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy~     with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world~     data according to Chinese physicians' clinical practice.~   "
163533|NCT01425281|"~     Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center~     clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular~     Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary~     Stent System (XIENCE)~   "
163534|NCT01425268|"~     This study is designed to compare the performance and safety of the AirXpander tissue~     expander to standard saline expanders in patients undergoing two-stage breast reconstruction~     following mastectomy.~   "
163535|NCT01425255|"~     The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake~     patterns in parents of children with type 1 diabetes (T1D) before and several weeks after~     initiating using real-time continuous glucose monitoring (RT-CGM) of their children.~   "
163565|NCT01424865|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in~     samples from patients with breast cancer previously treated in the NSABP-B-31 trial.~   "
163536|NCT01425242|"~     Inflammation of the blood vessel plays an important role in the development and growth of a~     dilated abdominal aorta. An elevated blood pressure leads to an increase in inflammation,~     therefore blood pressure lowering is an important part of the treatment of patients with a~     dilated abdominal aorta who also have an elevated blood pressure. In the investigators study~     the investigators compare the anti-inflammatory effects of 2 different blood pressure~     lowering strategies. The investigators hypothesize that both strategies will decrease~     inflammation, however the investigators believe the total decrease of inflammation depends on~     the type of blood pressure lowering medication used.~   "
163537|NCT01425229|"~     The aim of the present study is to assess the impact of the OATP1B1 genotype (SLCO1B1*15 vs.~     wild type; ~2% SLCO1B1*15 haplotypes in Caucasian population) and the CYP2C9 genotype (*2 and~     *3 allele vs. wild type; ~5% poor metabolisers in Caucasian population) on the~     pharmacokinetics of bosentan and the impact of CYP3A4-inhibition by clarithromycin on steady~     state bosentan which is a CYP3A4 inducer itself.~      This study will focus on differential effects of genotypes and co-medication on the~     pharmacokinetics of bosentan at the metabolic and transport level. Participants will be~     genotyped for CYP2C9 (inclusion criterion), OATP1B1 (inclusion criterion), and CYP3A5 (no~     inclusion criterion).~   "
163538|NCT01425216|"~     Treatment of keloid disorder is an area of unmet medical need. Current treatments for keloid~     partially address small and localized keloids, yet there are no wholly satisfactory or~     effective treatments for patients with extensive keloids. Such patients may benefit from~     effective systemic treatments.~      Sorafenib has the potential to regulate the three known dysregulated biological pathways in~     keloid tissue.~   "
163539|NCT01425203|"~     The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in~     combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective~     in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The~     primary hypothesis is that the percentage of participants achieving sustained virologic~     response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.~   "
163540|NCT01425190|"~     This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir~     following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric~     participants.~   "
163541|NCT01425177|"~     In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for~     the removal of bile duct stones.~      After procedures, there are some complications such as stone recurrence, papillary stenosis,~     cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite~     increasing experience and success with the procedure, occur in 4% to 24% of patients.~      Gallbladder stone, pneumobilia and many other various factors are known to be associated with~     CBD stone recurrence. Lithotripsy was also related to the development of recurrent stones. It~     is natural that small stone fragments left after lithotripsy may act as nidi for stone~     recurrence.~      Small remaining stone could not be completely detected only using ERCP stone removal and~     remaining stone removal can reduce residual and recurrent stones. Saline irrigation was~     effective immediately after ERCP stone removal to remove remaining small stones.~      Saline irrigation has many advantages such as easy to treatment during ERCP stone removal,~     almost no additional cost and rare side effect. This study The authors expect this study is a~     remarkable role of ERCP stone removal procedure.~   "
163542|NCT01425164|"~     In hemodialysed patients, coronary heart disease is the leading cause of mortality and~     morbidity. Most of the commonly used drug for ischemia are used in this patients, but few~     prospective data are available. Among anti-ischemic drugs betablocker provided evidence of~     beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used~     also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of~     benefit in general population, but no study is available in dialysis patients. Aim of the~     present study is to compare in a randomized, double-blind, parallel group trial the effects~     of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed~     population of patients with established coronary heart disease.~   "
163543|NCT01425151|"~     In the following randomized, crossover study, the investigators test the hypothesis that ease~     of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM~     in anesthetized pediatric patients.~   "
163544|NCT01425138|"~     This project involved a systematic literature review of published trials of treatments for~     moderate-to-severe plaque psoriasis. Data was extracted from the publications on various~     psoriasis endpoints including the Physician Global Assessment (PGA), Dermatology Life Quality~     Index (DLQI), and Short-Form 36 (SF-36). A traditional meta-analysis and a mixed treatment~     comparison was conducted on the extracted data.~   "
163545|NCT01425125|"~     Hyponatremia, defined as a serum sodium < 135 mmol/l, in patients without edema has undergone~     significant changes where it is now evident that even mild hyponatremia should be treated~     because of its association with symptoms, especially a fourfold increase in falls over the~     age of 65 years. There is an unresolved controversy over the relative prevalence of the~     syndrome of inappropriate secretion of antidiuretic hormone (SIADH) and cerebral/renal salt~     wasting (C/RSW). Resolution of this diagnostic dilemma becomes urgent because of divergent~     therapeutic goals, to water-restrict in SIADH or to give salt and water supplementation in~     C/RSW. The dilemma is compounded by recent reports of C/RSW occurring in patients without~     cerebral disease, thus adding further confusion in defining the relative prevalence of both~     syndromes. Because of overlapping laboratory and clinical findings in both syndromes, only~     differences in the state of extracellular volume differentiates one syndrome from the other,~     being high normal to increased in SIADH and decreased in C/RSW. The investigators have used~     fractional excretion (FE) of urate to categorize patients with hyponatremia. The increased~     FEurate that is observed in hyponatremic patients with SIADH and C/RSW can be used to~     differentiate both syndromes by correcting the hyponatremia and determining whether FEurate~     normalizes as in SIADH or remains increased in C/RSW. The present studies have been designed~     to determine total body water by deuterium and extracellular water by sodium bromide in~     patients with nonedematous hyponatremia with normal and increased FEurate to differentiate~     more conclusively whether the patient has normal or decreased water volumes. The~     investigators will also correct serum sodium rapidly with judicious administration of~     hypertonic saline over approximately three days and determine whether FEurate normalizes as~     in SIADH or remains increased as in C/RSW. In another group of patients, The investigators~     have data to suggest that those with normal sodium and increased FEurate is consistent with~     C/RSW. The investigators intend to do the same water volume studies to determine whether an~     increased FEurate with normonatremia would have decreased total and extracellular water that~     these patients have C/RSW without the need to correct a prior hyponatremia.~   "
163566|NCT01424852|"~     Aim: to examine caries occurrence in children who ten years ago received a mixture of~     probiotics during infancy.~      Hypothesis: the administration of probiotics during infancy has no effect on future dental~     health.~   "
163849|NCT01421160|"~     This study aims to determine the causal relationship between regulating urine pH levels~     between 7.0 and 7.5 and decreasing chronic joint pain. The investigators hypothesize that~     maintenance of an alkaline urinary pH will result in a decrease in personally reported levels~     of chronic joint pain using a citrate treatment regimen.~   "
163546|NCT01425112|"~     Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known~     to reduce neovascularization and fibrovascular proliferation in inflammatory conditions,~     including post-operative inflammation. It has shown efficacy in numerous ocular~     conditions(off-label), that includes Age related macular degeneration, proliferative diabetic~     retinopathy, neovascular glaucoma and corneal neovascularization. It is being explored as an~     option for preventing recurrence of pterygium and as an adjunct to improving outcomes of~     trabeculectomy. There is a debate as to the mode and duration of bevacizumab administration~     for trabeculectomy. This study aims to compare a single subconjunctival dose of bevacizumab~     with topical therapy over one month in terms of outcomes of trabeculectomy surgery,~     non-progression of field loss and stable intraocular pressure(IOP) control.~   "
163547|NCT01425099|"~     Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical~     development for the treatment of human immunodeficiency virus (HIV) infection. DTG is~     primarily metabolized by UDP-glucuronosyltransferase (UGT1A1) with cytochrome P450 (CYP)3A4~     pathway as a minor route. Corticosteroids have demonstrated induction effects on UGTs and~     CYP3A4. Corticosteroids are often used in HIV-infected subjects and have the potential to~     reduce DTG exposure due to enzyme induction when co-administered. The primary objective of~     this study is to determine whether concomitant prednisone administration can affect the~     pharmacokinetics (PK) of DTG.~      The study is a two part, two period, open label study. Part 1 will evaluate the effect of a~     high prednisone dose on DTG PK with the potential for an additional Part 2 depending on the~     results from Part 1. In Part 1, approximately 12 healthy subjects will receive DTG 50mg q24h~     for 5 days in Period 1. Subjects will then be administered DTG 50mg q24h in combination with~     prednisone 60mg for 5 days followed by a 5 day taper (total duration of 10 days) in Period 2.~     PK data of DTG will be obtained from Part 1 and used to inform decision making on the need~     for Part 2. If DTG exposure is reduced by more than 50% in Part 1, Part 2 will be carried out~     where a second cohort of subjects will receive DTG 50mg q24h DTG for 5 days in Period 1~     followed by DTG 50mg q24h in combination with prednisone 20mg for 5 days followed by a 5 day~     taper (total duration of 10 days) in Period 2. Safety evaluations and serial PK samples for~     DTG will be collected during each treatment period. A follow-up visit will occur 7-14 days~     after the last dose of study drug. All doses of study drugs will be taken following a~     moderate fat meal. This study will be conducted at one center in the United States, with~     healthy adult male and female subjects.~   "
163548|NCT01425086|"~     The purpose of this pilot study is to evaluate the performance of a new warming technology~     (Embrace Isothermal Mattress) during the thermal weaning of premature infants from incubators~     to open cribs. The investigators aim to study the Embrace Isothermal Mattress over a 24-hour~     period before the infant is transitioned out of the incubator.~   "
163549|NCT01425073|"~     Both antiretroviral therapy (ART) and prevention of opportunistic infections (OIs) have been~     associated with significantly decreased mortality in HIV-infected individuals.~     Trimethoprim-sulfamethoxazole (TMP/SMZ), also known as bactrim, is a common antibiotic and~     used as prophylaxis for OIs. For countries with high prevalence of HIV and limited health~     infrastructure, the WHO endorses universal TMP/SMZ for all HIV-infected individuals. Notably,~     these guidelines were created prior to the scale-up of ARTs. Following ART and subsequent~     immune recovery, TMP/SMZ may no longer be required. In the US and Europe, for example,~     TMP/SMZ is discontinued after patients show evidence of immune recovery. Therefore, we~     propose a prospective randomized trial among HIV infected individuals on ART with evidence of~     immune recovery (ART for > 18mo and CD4 >350 cells/mm3) to determine whether continued~     TMP/SMZ prophylaxis confers benefits in decreasing morbidity (malaria, pneumonia, diarrhea),~     mortality, CD4 count maintenance, ART treatment failure and malaria immune responses.~   "
163550|NCT01425060|"~     Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was~     unintended and the majority of non-pregnant opioid-maintained women do not use contraception~     or use less effective methods like condoms. This proposal aims to develop and test a novel~     contraceptive management program to increase use of more effective contraceptives among~     opioid-maintained women and to examine the impact of more effective contraceptive use on~     condom use. The proposed research may reduce unintended pregnancy among opioid-dependent~     women without increasing their risk of sexually transmitted infections and the knowledge~     gained will also have implications for addressing high rates of unintended pregnancy in the~     general population.~   "
163551|NCT01425047|"~     Mangosteen is a tropical tree. The peel of mangosteen fruit is used in traditional medicine.~     The purpose of this study was to determine the bioavailability of the xanthones from~     mangosteen juice in adult human subjects.~   "
163552|NCT01425034|"~     Carpometacarpal (CMC) arthritis of the thumb joint ('basal arthritis') is a common entity~     treated by hand surgeons in our society. It can be a significant source of functional~     disability secondary to a painful, and often weak, grip. Once patients have failed treatment~     by conservative means, such as splinting, anti-inflammatories, and cortisone injections, the~     next option is surgical management. Several surgical options are available depending on the~     severity of the disease. For the early stages of arthritis options include a ligament~     reconstruction or a metacarpal extension osteotomy. For advanced stages, only salvage~     procedures exist. These have included simple trapeziectomy, arthrodesis and implant~     arthroplasty. The most common procedure, however, has been a trapeziectomy with a ligament~     reconstruction tendon interposition~   "
163553|NCT01425021|"~     The goal of this is to improve durability of total joint replacements in patients, thereby~     improving clinical outcomes and implant performance. To reach this objective, our research~     program would like to assess the safety, efficacy, performance, and durability of FDA~     approved biomaterial and implant designs used in joint replacements.~   "
163554|NCT01425008|"~     This is a phase 1, multicenter, nonrandomized, open-label, dose escalation study. The study~     will be conducted in 2 stages, Dose Escalation and Dose Expansion. The Dose Escalation phase~     will include patients with solid tumors (including melanoma) who have failed or are not~     candidates for standard therapies or for whom no approved therapy is available. The Dose~     Expansion phase will include patients with metastatic melanoma.~   "
163555|NCT01424995|"~     This will be a prospective study of all children ages 0 - 5 years old at the time of entry~     into the study that meet the inclusion criteria who present with congenital trigger thumb.~     Patient records will be reviewed for eligibility before obtaining parental permission. They~     will be enrolled in the study at their first visit and followed every year for up to 4 years~     or until one of the exclusion criteria are met. Participating sites include the University of~     Utah Orthopaedic Center, Primary Children's Medical Center and Shriners Hospital for~     Children.~   "
163703|NCT01423071|"~     The purpose of this study is to determine the prevalence of pulmonary hypertension (PH) among~     patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and to assess the~     quality of life in those patients with concomitant PH compared to COPD patients without PH~     and those only suffering from pulmonary arterial hypertension (PAH) respectively.~   "
163556|NCT01424982|"~     The goal of this clinical research study is to learn if intensive chemotherapy combined with~     ponatinib, followed by maintenance therapy, can help to control ALL with the Ph chromosome~     and/or BCR-ABL. The safety of this treatment will also be studied.~      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location~     of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or~     death. A blood clot may occur within 2 weeks after you start taking the drug. About 25% (1 in~     4) of patients taking the drug form an abnormal clot. Blood clots can occur in patients that~     do not have other known risk factors for forming clots. If you develop a blood clot, you will~     need to stop taking ponatinib. In some cases, emergency surgery could be needed to remove the~     clot and restore blood flow.~      This is an investigational study. Ponatinib is FDA approved to treat patients with certain~     types of leukemia. Its use in this study is investigational.~      All other drugs used in this study are FDA approved and commercially available. Their use~     together in this study is investigational.~      Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.~   "
163557|NCT01424969|"~     The purpose of this study was to determine the effect of platelet-rich fibrin matrix (PRFM)~     augmentation to at-risk arthroscopic rotator cuff repairs on healing rates and functional~     outcome scores. The investigators performed an observational cohort study in which a~     consecutive series of patients with rotator cuff tears at risk for retear was prospectively~     evaluated after arthroscopic repair augmented with PRFM. Clinical and magnetic resonance~     imaging (MRI) outcomes of the PRFM-augmented repairs were compared with historical controls~     with similar at-risk tears without PRFM augmentation.~   "
163558|NCT01424956|"~     To determine the impact on Interpreting Physician performance in detecting breast cancer, as~     defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated~     Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening~     mammography alone in asymptomatic women with >50% parenchymal density and a screening~     mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign~     findings).~      The effect of the improved Reader performance is illustrated by plotting the ROC curves for~     XRM alone and XRM+ABUS. If Reader performance improves with the addition of ABUS to the XRM,~     the area under the curve (AUC) for XRM+ABUS (AUCXRM+ABUS) will be greater than the area under~     the curve for XRM Alone (AUCXRM Alone). This difference is represented as ∆AUCABUS. The null~     and alternative hypotheses can be formally expressed as follows:~      H0: ∆AUCABUS = 0, AUCXRM+ABUS = AUCXRM Alone The null hypothesis is that Reader performance~     will be unchanged with the addition of ABUS to a screening mammogram assigned a BI-RADS~     Assessment Category of 1 or 2.~      HA: ∆AUCABUS ≠ 0, AUCXRM+ABUS ≠ AUCXRM Alone The alternative hypothesis is that Reader~     performance will be changed with the addition of ABUS to a screening mammogram assigned a~     BI-RADS Assessment Category of 1 or 2. A statistically significant change will be considered~     equivalent to a statistically significant improvement if the estimated value of AUCXRM+ABUS~     is greater than that of AUCXRM Alone with statistical significance at an alpha level of .05~     for a two-sided test.~   "
163559|NCT01424943|"~     The purpose of the project is to assess the initial efficacy of Stepping Stones Triple~     P-Positive Parenting Program (SSTP) with parents of children below age two with developmental~     disabilities to strengthen families and prevent child maltreatment.~   "
163560|NCT01424930|"~     The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone~     acetate and oral prednisone following short-term administration after standardized low-fat or~     high-fat meals to patients with metastatic (spreading) castration-resistant prostate cancer~     (mCRPC).~   "
163561|NCT01424917|"~     Post transplant vasculopathy is a major negative outcome in heart transplantation. Current~     methods of detection are highly invasive and pose a risk to transplant recipients.~     Noninvasive markers of endothelial function can be used to detect transplant vasculopathy.~     Endothelial biomarkers such as: endothelial nitric oxide synthase, vascular cellular adhesion~     molecules, intracellular adhesion molecules, endothelin-1, thromboplastin, circulating~     endothelial cells, uric acid, and C-reactive play a role in the pathophysiologic mechanism of~     vasculopathy. Therefore, the investigators would like to assess the association between~     various endothelial biomarkers and the presence or absence of transplant vasculopathy.~   "
163562|NCT01424904|"~     The purpose of this research is to evaluate the effects of DGB-01 on performance of a 40‐km~     time trial in trained male cyclists. The investigators believe that DGB-01 will improve~     performance on the time trial as measured by a reduction in the amount of time required to~     complete the distance, using a computerized cycle ergometer.~   "
163563|NCT01424891|"~     Lowering LDL cholesterol by statins has been proven to be associated with reduction of~     proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the~     effects of newer cholesterol lowering agents such as ezetemibe with respect to their~     anti-inflammatory potential are less intensively studied. Therefore the investigators~     analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination~     with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear~     cells (PBMCs) of patients with type 2 diabetes.~   "
163564|NCT01424878|"~     Background:~      Medullary thyroid carcinoma (MTC) is a rare malignancy, occurring either as a sporadic~     disease (75% of cases), or in a hereditary pattern as multiple endocrine neoplasia (MEN) type~     2 (MEN2A or MEN2B) or familial medullary thyroid carcinoma (FMTC). The MTC arises from the~     neural crest C-cells and in hereditary cases the first pathological disorder is C-cell~     hyperplasia (CCH) Most patients with MTC have advanced disease at the time of diagnosis.~      Chemotherapy and external beam radiotherapy have been minimally effective. Molecular targeted~     therapeutics (MTTs) and other receptor kinases in patients with advanced MTC have~     demonstrated activity.~      Despite some clinical responses, the collection of tumor tissues and autologous normal~     tissues has been virtually non-existent. Thus, laboratory studies defining affected molecular~     targets and downstream pathways, and molecular data providing direction for future clinical~     trials has yet to occur.~      Data from molecular studies of tumor tissue of hereditary or sporadic MTC patients will~     assist in predicting clinical behavior and the biology of MTC in predicting response to a~     given MTT, and in designing combination clinical trials.~      Objectives:~      Clarify how normal molecular pathways are altered by mutations in the RET protooncogene.~     Including additional genetic mutations and unidentified chromosomal translocations.~      Correlate results from molecular analyses of MTC tissue with patient s clinical course.~      Define how the molecular and clinical data will be useful in designing targeted therapy for~     patients with MTC.~      Eligibility:~      Patients must have confirmed diagnosis of C-cell hyperplasia, primary MTC, or metastatic MTC~     with archived pathology specimens available at Washington University.~      Design:~      Paraffin blocks of MTC tissues from archival samples at Washington University Department of~     Pathology will be selected.~      H&E slide from selected tissue blocks will be examined for molecular study suitability.~      Necessary tissue samples from blocks will have molecular studies, including, gene arrays,~     array comparative genomic hybridization, immunohistochemistry, and sequencing.~      Retrospective chart review will occur to obtain relevant clinical information.~   "
163567|NCT01424839|"~     STUDY DESIGN:~      Prospective, non-randomised multicentre study with patients stratified according to risk~     groups INVESTIGATIONAL MEDICINAL PRODUCTS The IMPs on this trial are Carboplatin, Cisplatin,~     Ifosfamide and Etoposide (as approved by German competent authority).~      PRIMARY OBJECTIVES:~      Germinoma~        -  To maintain current high event-free survival (EFS) rates using a risk adapted approach~        -  In localised germinoma: to omit whole brain and spinal irradiation by using combined~          treatment with standard chemotherapy and ventricular irradiation (+/- boosts)~        -  In bifocal tumours (pineal + suprasellar): to treat as non-metastatic disease and to~          omit whole brain and spinal irradiation by using combined treatment with standard~          chemotherapy and ventricular irradiation (+/- boosts)~        -  In metastatic disease: to maintain current excellent EFS in metastatic germinoma with~          craniospinal irradiation Malignant non-germinoma~      To improve EFS:~        -  by dose escalation of chemotherapy in patients identified as high risk at diagnosis (~          age < 6 years and/or AFP serum / CSF > 1000 ng/ml)~        -  by standardising the surgical approach for residual disease after treatment Teratoma~        -  To register patients and collect data regarding diagnostics, treatment and outcome in~          order to develop future treatment strategies~      SECONDARY OBJECTIVES:~      Germinoma~        -  To minimise long term effects of irradiation by sparing spinal and whole brain~          radiotherapy in non-metastatic disease Malignant non-germinoma~        -  In standard risk to maintain EFS with chemotherapy and local irradiation Teratoma~        -  To evaluate the influence of surgery and treatment on outcome to assist in the~          development of a fu-ture treatment strategy For all histological subtypes~        -  To improve accuracy of diagnosis and staging in all registered patients~        -  To standardise neurosurgical intervention~        -  For all patients requiring biopsy or resection according to protocol guidelines, to~          collect and to store tumour material, and CSF where possible, for use in future~          biological studies.~      ENDPOINTS / Criteria for evaluation:~      Main end point~      Event-free survival, defined as minimum time from the date of diagnosis to:~        -  Death from any cause~        -  Relapse~        -  Progressive disease on therapy~        -  Or second malignancy~      Secondary end points~        -  Overall survival, defined as time to death from any cause, measured from the date of~          diagnosis~        -  Short and long term toxicity.~   "
163568|NCT01424826|"~     This study seeks to address the question of whether intermittent dosing of rifampicin~     influences the pharmacokinetics of raltegravir when co-administered. This study aims to look~     at what happens when rifampicin is taken 3 times a week with the standard dose and an~     increased dose of raltegravir. This is to find out the best dose of raltegravir to take when~     taking rifampicin 3 times a week. The study will be conducted in 18 healthy volunteers.~   "
163569|NCT01424813|"~     The study will measure the change in lung function in subjects with asthma after inhaling~     from either of two inhalers: Albuterol Spiromax® or placebo.~   "
163570|NCT01424800|"~     This study emphasizes on the influence of changes in systemic flow and systemic mean arterial~     blood pressure (MAP) during cardiopulmonary bypass (CPB) on cerebral oxygenation assessed by~     near-infrared spectroscopy (NIRS). The aim of the study is to determine whether variations in~     systemic flow, in MAP, or in both variables at the same time have the greatest impact on the~     cerebral oxygen saturation.~   "
163571|NCT01424787|"~     The objective of this non-interventional study is to confirm that with standard OsvaRen®~     treatment it is possible to achieve in at least 60% of the patients the levels of phosphorus,~     total calcium, and iPTH seen in the CALMAG study also in the normal clinical practice.~   "
163572|NCT01424774|"~     This study will be performed at clinical sites that have administered CardioGen-82® to~     patients from January to July 2011. The patients enrolled(i.e., target date patients) will~     be all those who were dosed at the end of use of the CardioGen-82® generators on the last day~     of generator use from the generator that was used immediately prior to the recalled generator~     (i.e., target date generators). These are not patients who received drug eluted from the~     recalled generator. Of these patients, it is planned that 100 patients will be entered in~     this trial.~   "
163573|NCT01424761|"~     Cardiovascular disease (CVD) is the leading cause of Taiwan. American Heart Association (AHA)~     indicated that CVD patients with Statin therapy would decrease the recurrence of CVD. The~     goal for lipid lowering in CVD patients was set at the level of low-density lipoprotein~     cholesterol (LDL-C) below 100 mg/dL. Coenzyme Q10 is recognized as a lipid soluble~     antioxidant, Statin treatment might affect the level of coenzyme Q10. Therefore, the purposes~     of this study are going to investigate the relation of coenzyme Q10 with other antioxidant~     vitamins (Vitamin A and E), the markers of lipid peroxidation, antioxidant enzymes~     activities, and the inflammatory markers in coronary artery disease (CAD) patients during~     Statin therapy. The study is going to design a placebo-controlled study. The investigators~     will recruit coronary artery disease (CAD) patients who are identified by cardiac~     catheterization as having at least 50% stenosis of one major coronary artery, and healthy~     subjects. CAD subjects are randomly assign to placebo and coenzyme Q10 supplements (150~     mg/bid = 300 mg/d) groups. Intervention is going to administration for three months. Fasting~     blood will be obtained in each month and determine the concentration of antioxidant vitamins,~     lipid peroxidation markers, antioxidant enzymes activities after intervention. Meanwhile, the~     investigators will measure the level of inflammatory markers in all subjects of this study.~     Hopefully, the results of this study could provide information of coenzyme Q10~     supplementation for clinical dietitian in advising CAD patients who are under Statin therapy.~   "
163574|NCT01424748|"~     For 28 days, healthy volunteers will consume one of four daily quantities of Tahitian Noni~     juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. Hematology, biochemistry, urinalysis, vital~     signs, and adverse events measurements will be made at 0 (baseline), 2, and 4 weeks, as well~     as during a two-week follow up (week 6). Electrocardiogram (ECG) measurements will also be~     made for each volunteer during the pre-study screen and at week 6.~   "
163575|NCT01424735|"~     Although idiopathic steroid resistant optic neuritis is very uncommon, there is no~     established treatment protocol for such patients. Toll like receptors (TLRs) especially TLR-9~     has been shown to play a role in the pathogenesis of optic neuritis. This small case series~     aims to determine whether immunomodulators directed specifically at TLR-9(i.e. TLR-9~     antagonism)play any role in improving the visual function in such patients.~   "
163576|NCT01424722|"~     This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption~     (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the~     ST Monitoring Feature in St Jude Medical ICD systems.~   "
163577|NCT01424709|"~     Gemcitabine, docetaxel, CPT-11 and cisplatin are effective in 1st line treatment of advanced~     non-small cell lung cancer (NSCLC). Platinum-based doublets including gemcitabine, docetaxel~     or CPT-11 are standard 1st regimens. BRCA1 and RRM1 expression levels are reported to be~     associated with sensitivity of the tumor cells to cytotoxic agents. Some Phase II or III~     trials did prove feasibility of customized chemotherapy based upon expression levels of one~     or two biomarkers in the NSCLC patients. The investigators think customized chemotherapy may~     further improve efficacy of chemotherapy in advanced NSCLC. But there is no randomised trial~     to compare efficacy of standard chemotherapy with individualized chemotherapy in this~     setting. So, the investigators plan to initiate this phase II trial to compare efficacy~     between standard chemotherapy of gemcitabine/cisplatin versus customized chemotherapy in~     chemonaive NSCLC patients.~   "
163578|NCT01424696|"~     Cystic fibrosis (CF) is a life-shortening disease that causes breathing and digestive~     problems, but can now be diagnosed at the time of birth. Lung function is very hard to~     measure in infants, but growth is not. In this study the investigators aim to define growth~     in infants with CF in the first year of life with research quality precision and to~     understand factors that interfere with good growth.~      Pancreatic enzyme replacement therapy (PERT) will be also be studied in a subgroup of~     infants. Two different doses of PERT will be evaluated for improving fat and nitrogen~     absorption in infants with CF.~   "
163579|NCT01424683|"~     The objective of this study is to investigate how mobility and pain scores, measured on a~     Visual Analogue Scale (VAS), correspond to patients' EuroQol-5Dimensions-3Levels (EQ-5D-3L)~     answers on pain and mobility. In addition, the investigators want to evaluate patients'~     undergoing Coronary Artery Bypass Grafting (CABG) quality of life postoperatively, depending~     on the vein harvesting method used.~   "
163580|NCT01424670|"~     The purpose of this trial is to determine whether delamanid is effective in the treatment of~     Multidrug-resistant Tuberculosis (MDR TB) in combination with other MDR TB medications during~     6 months of treatment.~   "
163581|NCT01424657|"~     The main objective of this study is to assess the effectiveness and costs of magnetic~     resonance cholangiopancreatography (MRCP) and compare it to endoscopic retrograde~     cholangiopancreatography (ERCP) in the work up of patients with suspected bile duct~     obstruction on ultrasound. The investigators do not anticipate that a universal~     recommendation for a given diagnostic test (MRCP versus ERCP) will be applicable in all~     patients presenting with bile duct obstruction. Rather, the investigators hope to provide~     quantitative and comparative data relevant to the different clinical situations likely to be~     encountered in practice, in order to assist physicians in choosing the appropriate diagnostic~     modality. More specifically, the investigators feel that patients with intrahepatic or hilar~     obstruction (particularly those with malignant conditions), and those with partial common~     bile duct (CBD) obstruction (to rule out suspected choledocholithiasis) will benefit most~     from this new technology and the avoidance of an unnecessary ERCP to further determine the~     biliary anatomy.~   "
163582|NCT01424644|"~     The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline,~     Boostrix®) and HPV vaccine (Merck & Co., Inc., Gardasil®) when administered concomitantly~     with MenACWY are comparable to responses elicited by these vaccines when given alone.~   "
163583|NCT01424631|"~     This is a randomized prospective study comparing single incision versus conventional~     laparoscopic appendectomy for management of acute appendicitis.~   "
163584|NCT01424618|"~     This study compares two different methods to prepare the uterine lining of recipients for~     implantation in cycles using donor eggs. The study method requires less time than the~     standard method.~      It is hypothesized that both methods would be suitable for use in egg donor cycles.~   "
163585|NCT01424605|"~     Double-lumen bronchial tube (DLT) had been demonstrated to benefit for thoracic surgery and~     also played an important role to achieve one-lung ventilation (OLV) for exploring the~     surgical fields. However, compared with the single-lumen endotracheal tube (SLT), the DLT had~     larger OD (outer diameter), longer length, and was more complex in its structure. For~     avoiding oral tissue trauma and shortening the DLT intubating time, thus, an adequate and~     complete glottic viewing under laryngoscope was needed.~      Over the past decade, several video-assisted laryngoscopes had been developed to facilitate~     the tracheal intubation in the difficult airway. Among these devices, the GlideScope®~     videolaryngoscope (GVL) (Verathon, Bothell, WA, USA) was a reusable video laryngoscope with a~     60° curvature blade. A light source and a digital video camera were installed at the tip of~     the laryngoscope blade and the pictures of the glottis and the vocal cords were displayed on~     an LCD monitor. We could insert the endotracheal tube passing the vocal cords into the~     trachea more precisely and had less tissue damaging under the GVL's guidance.~      Compared with direct MacIntosh laryngoscope, the GVL had been reported that it can decrease~     the intubation time and increase the successful rate of first intubation in normal and~     difficult airways. However, the efficacy of the GVL in intubating the DLT was unclear and had~     never been evaluated. Therefore, the aim of this study was to compare the intubation~     conditions, safety, and patient comfort between using the GVL and the direct Macintosh~     laryngoscope in a specific population of patients needed DLT intubation. Main outcome~     measures were intubation success rates and the time needed to intubate the DLT with the two~     devices.~   "
163586|NCT01424592|"~     Hypothesis: Portable sleep testing of hospitalized medical inpatients suspected of having OSA~     is accurate in determining the need for positive airway pressure (PAP) therapy when compared~     to outpatient laboratory-based polysomnography.~        -  Hospitalized medical inpatients referred for suspected OSA will be tested with a~          portable sleep apnea testing device during hospitalization.~        -  These patients will then undergo an outpatient laboratory-based attended polysomnography~          after hospital discharge.~        -  Results of the inpatient portable sleep apnea test will be compared to the outpatient~          laboratory-based polysomnography in terms of diagnostic accuracy.~   "
163587|NCT01424579|"~     Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high~     lifetime prevalence (one in three) in general population. In occupational population is the~     most common upper extremity disorder. Symptoms include pain, a variable degree of mobility~     limitation and a more or less pronounced functional impairment. Conservative treatment is~     usually the first therapeutic option and some physiotherapeutic techniques have proved its~     efficacy but nevertheless treatment remains challenging.~      According to the investigators clinical experience, Diacutaneous Fibrolysis has a beneficial~     effect on patients suffering from SIS, but no one published clinical trial has evaluated this~     manual technique previously. The investigators hypothesis is that adding Diacutaneous~     Fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. The~     investigators objective was to assess the effect of Diacutaneous Fibrolysis on pain, mobility~     and functional status in patients suffering from SIS.~      A double-blind (patient and evaluator) randomized clinical trial was carried out in two~     public centres of Primary Health Care of the Spanish National Health System. The study~     protocol was approved by the Clinical Research Ethics Committee from the Jordi Gol Institute~     of Research in Primary Health Care and all the patients provided written consent.~      A hundred and twenty patients with clinical diagnosis of SIS were included and randomly~     allocated to one of three groups. All groups received the same daily protocolized treatment~     based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks.~     Additionally, intervention group received six sessions (two a week) of actual Diacutaneous~     Fibrolysis; placebo group received six sessions (two a week) of placebo Diacutaneous~     Fibrolysis, while control group received only the protocolized treatment.~      Pain intensity (VAS), active range of motion (flexion, abduction, extension, external and~     internal rotation) and functional status (Constant-Murley score) were measured in baseline,~     after the three weeks of treatment and three months after the end of treatment.~   "
163756|NCT01422382|"~     This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug~     interaction study.~   "
163588|NCT01424566|"~     The primary objective of this study was to evaluate the efficacy of nabiximols (Sativex®),~     compared with placebo, when used as an adjunctive measure in relieving uncontrolled~     persistent chronic pain (not breakthrough pain) in participants with advanced cancer, who had~     inadequate analgesia even with optimized chronic opioid therapy.~      This multi-center study was conducted in two parts. All participants enrolled into the trial~     received nabiximols during one of two parts of the study, but they did not know which part.~      Eligible participants were not required to stop any of their current treatments or~     medications.~   "
163589|NCT01424553|"~     EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be~     evaluated in very low birth weight and term infants, born in 1997 and included in the French~     EPIPAGE cohort.~   "
163590|NCT01424540|"~     This is a single-center, randomized, two part, double-blind, crossover study in healthy adult~     subjects to assess the effect of a single dose of GSK2336805 150mg on cardiac function~     comparing with placebo using echocardiography as a primary assessment modality~   "
163591|NCT01424527|"~     This is a cross-sectional validation study, designed to evaluate the discriminative validity~     of the Chronic Obstructive Pulmonary Disease Assessment Test translated in a local language~     in patients with Chronic Obstructive Pulmonary Disease.~   "
163592|NCT01424514|"~     The purpose of this study is to assess the pharmacodynamic (PD) effects (Total Symptom Score~     (TSS) and its individual components: rhinorrhoea, nasal congestion, post-nasal drip) of~     intranasal, repeat dose SB-705498 in non-allergic rhinitis (NAR) patients elicited by a cold~     dry air challenge in an environmental exposure chamber (EEC). SB-705498 is a selective~     antagonist of the transient receptor potential vanilloid-1 (TRPV1) ligand gated ion channel.~     TRPV1 is a cation permeable ion channel that can be activated by several physiological~     factors, such as heat, protons (pH), osmotic stress, eicosanoid derivatives, anandamide, and~     by products of inflammation, such as histamine, prostaglandins and bradykinin. In the nose,~     the local TRPV1 expressing sensory C-fibres are thought to play a key role in the development~     of nasal hyper-responsiveness to environmental provocateurs. It has been proposed that~     blocking the nasal sensory nerve stimulation may control nasal hyper-responsiveness and~     therefore prevent the induction of rhinitis symptoms. In this context, preclinical evidence~     supports that targeting TRPV1 by SB-705498 may be an attractive option.~      In this study NAR patients will be randomised, in a double blind, placebo controlled cross~     over design to receive 14 day repeat doses of 12mg intra-nasal SB-705498 once daily. Whilst~     dosing at home, subjects will record symptom scores to document their symptoms. In addition,~     during visits to the clinical unit, acoustic rhinometry, quality of life questionnaires and~     safety assessments will be monitored.~   "
163593|NCT01424501|"~     This study will assess the safety and immunogenicity of GSK Biologicals' investigational~     tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months~     to human immunodeficiency virus (HIV) negative adults who have received treatment for TB~     disease (denoted TB-treated cohort) or are currently receiving treatment for TB disease~     (denoted TB-treatment cohort). For comparative purposes, subjects who have never had TB~     disease (denoted TB-naïve cohort) will also be enrolled.~   "
163594|NCT01424488|"~     Primary objectives:~        1. to investigate the efficacy of sugammadex in dose of 4 mg/kg administered at~          reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade in~          subjects undergoing abdominal surgery under general anesthesia~        2. to evaluate the safety and tolerability of a single dose of 4 mg/kg sugammadex~          administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular~          blockade~      Secondary objectives:~      1. to evaluate the time from the start of sugammadex or placebo administration to the time of~     extubation and to the time of recovery of TOF ratio to ≥ 0.9~      Exploratory objectives:~        1. to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay~          after the end of surgery in subjects with pipecuronium induced neuromuscular blockade~          reversed by 4.0 mg.kg-1 sugammadex compared to placebo (saline)~        2. compare the number of patients extubated in the OR after the reversal by sugammadex or~          placebo, evaluate the TOF ratio at the time of extubation~      Clinical hypothesis:~      1. Sugammadex has to be effective and well tolerated for reversal of pipecuronium-induced~     blockade~   "
163595|NCT01424475|"~     The Leucine-Rich Repeat Kinase 2 (LRRK2) is implicated in autosomal dominant Parkinson's~     disease (PKD). An inhibitor for the leucine-rich repeat kinase 2 (LRRK2) is in pre-clinical~     development for potential use in treating Parkinson's disease. Patients with PKD have~     cognitive impairments which develop alongside the typical motor symptoms but a full~     characterisation of the neurocognitive phenotype of PKD patients with LRRK2 mutation is~     currently lacking. This observational study conducted on a single visit will assess the~     phenotypic neurocognitive abnormalities of PKD patients with the LRRK2 mutation with the aim~     of identifying potential PD endpoints related to the LRRK2 mutation for future Phase I or II~     clinical trials of LRRK2 inhibitors.~   "
163596|NCT01424462|"~     This study will investigate how 3 new types of drug formulations are absorbed by the body.~     This study is termed 'open-label', which means volunteers will be aware of which treatment~     they are receiving. The study involves all volunteers receiving all 3 different formulations,~     as a single dose, and there is no placebo (dummy-drug; no active ingredient) in this study.~     Volunteers will also receive a single dose of a formulation used in previous trials~     (reference formulation), so as a proper comparison with the new formulations can be made. One~     of the new formulations will also be administered along with food, to assess if the drug~     performs or is absorbed differently.~   "
163597|NCT01424449|"~     This will be an open label, non-randomised [11C]PHNO PET study using healthy male volunteers.~     Each volunteer will undergo 4 [11C]PHNO PET scans to allow for further characterisation of~     this radioligand and examine the effects of [11C]PHNO mass carry-over and displaceable~     binding in the brain. This study aims to obtain data from 6 evaluable subjects.~   "
163598|NCT01424436|"~     Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild~     Alzheimer's disease or mild cognitive impairment~   "
163599|NCT01424423|"~     The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein~     that prevents nerve growth.~      The trial is expected to involve approximately 36 patients. The study objective is to~     investigate the tolerability, safety and the way the body handles GSK1223249 after a range of~     single doses in patients with Multiple Sclerosis (MS).~   "
163600|NCT01424410|"~     Objective and Hypotheses: This project has the overall objective of implementing and~     evaluating new approaches to reducing the current and future burden of urinary~     schistosomiasis in young children using the antihelminthic drug praziquantel. The~     investigators hypotheses are that (1) praziquantel treatment will be as effective in children~     1 to 5 years of age (who are routinely excluded from schistosomiasis control programmes) as~     it is in older 6-10 year old children and (2) two treatments will be more effective than a~     single treatment, especially in children 1 to 5 years of age.~   "
163601|NCT01424397|"~     This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms~     induced by an allergen chamber challenge.~   "
163602|NCT01424384|"~     This will be a phase I, single centre, randomised, double blind, double-dummy, placebo~     controlled, parallel group single-dose study in healthy volunteers. The purpose of this study~     is to assess the effect of a single-dose administration of GSK424887, a potent, selective~     competitive antagonist of the human Neurokinin 1 (NK1) receptor and a potent inhibitor of the~     human serotonin transporter (SERT), at the maximum dosage of 100 mg versus placebo and versus~     citalopram (20 mg) on emotional processing in healthy male volunteers. Pharmacokinetics and~     safety following oral administration of GSK424887 will be also evaluated. An Emotional Test~     Battery (ETB) previously used to characterise the effects of antidepressants on positive and~     negative emotion processing in Healthy Volunteers and patients will be used. We hypothesise~     that GSK424887 will modulate emotional information processing acutely. We anticipate that~     these effects may be manifest at sub-effective levels of NK1 and SERT receptor occupancy,~     thus providing pharmacodynamic evidence of the synergistic interaction of the two mechanisms~     in humans.~   "
163603|NCT01424371|"~     This study explores the hypothesis that the use of an adjuvanted influenza vaccine in the~     elderly will produce greater vaccine effectiveness in their group.~   "
163604|NCT01424358|"~     Objective:~      The experimental design is a one-site, randomized experimental web-based educational~     feasibility intervention trial, with approximately 50% primary care physicians (PCPs) in the~     intervention group and approximately 50% PCPs on the control group, giving a total of 159~     participants. All 159 participants have willingly provided their e-mail addresses, as part of~     a survey they previously completed entitled, Survey of Health Professionals on Oral Cancer~     in Ohio- Intervention to Prevent Delayed Diagnosis of Oral Cancer.~   "
163605|NCT01424345|"~     The purpose of this study is to demonstrate whether there are any outcome benefits of a~     serial ImmuKnow assays in the management of de novo renal transplant recipients.~   "
163606|NCT01424332|"~     The primary objective of this study is to evaluate whether ASA and darexaban which have~     different effects on blood coagulation influence each other in their effects. Also it will be~     investigated whether the blood levels of either drug are influenced by the presence of the~     other drug. In addition, the safety and tolerability of each drug and the combination of the~     drugs will be investigated.~   "
163607|NCT01424319|"~     Prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. The~     objective of the study is to evaluate the efficacy and safety of once daily administration of~     atrasentan tablets compared to placebo in reducing residual albuminuria in Japanese Type 2~     diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose~     for hypertension of a RAS (renin angiotensin system) inhibitor.~   "
163608|NCT01424306|"~     People with chronic low-grade inflammation have a higher risk for certain diseases such as~     cardiovascular disease or type 2 diabetes. While it is known that obese people are more~     likely to show signs of low-grade inflammation than lean individuals, it is unclear what~     causes this inflammation. In the proposed study, the investigators will examine whether the~     sugar fructose, when consumed in a sweetened beverage, triggers low-grade inflammation in~     healthy men and women compared with other caloric sweeteners.~   "
163609|NCT01424293|"~     Bowel removal is indicated for various types of colon and rectal disease, including colon~     cancer, rectal cancer, diverticulitis, and inflammatory bowel disease among others.~      Following removal of the diseased segment of bowel your surgeon will reconnect the two~     healthy ends to reconstruct a continuous bowel tube. If the bowel leaks it can become an~     extremely dangerous situation.~      The cause of leakage has many causes and is not well understood, but appears to be at least~     in part due to not having enough blood going to the bowel. There is currently no way to~     evaluate the blood supply to the bowel.~      The purpose of this study is to utilize a special camera to evaluate the blood supply of the~     bowel. This new system is called the Spy-scope. This system may assist surgeons in reducing~     the occurrence of leaks~   "
163610|NCT01424280|"~     The purpose of this study is to assess bronchodilator effect after single dose administration~     of GSK1440115 in a population of mild to moderate asthmatic patients.~   "
163611|NCT01424267|"~     A registry to collect additional prospective intra-operative and follow-up information on~     physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA)~     Endovascular Graft under routine clinical care.~   "
163612|NCT01424254|"~     The study objective is to compare the cost-effectiveness of VCE to push enteroscopy in~     patients with gastrointestinal bleeding of obscure origin with a negative initial work-up.~   "
163613|NCT01424241|"~     This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF1)~     normalization into current IGF1 normal ranges with Sandostatin LAR® therapy on biochemical~     metabolic, cardiovascular and body composition parameters in patients with active acromegaly.~   "
163614|NCT01424228|"~     The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride~     versus placebo in subjects aged 18 years and older with chronic constipation.~   "
163615|NCT01424215|"~     The purpose of this study is to evaluate whether a fluorescent die and a special infrared~     camera can assist with the identification of the important structures during laparoscopic~     cholecystectomy. This finding may assist surgeons to perform laparoscopic cholecystectomy in~     less time and in a safer fashion than standard laparoscopic cholecystectomy.~   "
163631|NCT01424007|"~     The purpose of the MENU Study is to examine whether there is a differential weight loss~     response to different dietary macronutrient composition (higher carbohydrate and lower fat~     versus lower carbohydrate and higher monounsaturated fat [MUFA] or lower carbohydrate and~     walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending~     on insulin resistance status. Blood samples will be collected to enable analysis of potential~     mechanisms and differential response across subgroups.~   "
163616|NCT01424202|"~     Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the~     incidence of re-intubation and ICU length of stay. However, the role of NIV in~     post-extubation failure is still not clear. Impaired airway clearance is associated with NIV~     failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that~     has been proven to be very effective in patients under NIV.~      In this study the investigators assess the efficacy of MI-E as part of a protocol for~     patients that develop respiratory failure after extubation.~   "
163617|NCT01424189|"~     The purpose of this study is to evaluate the safety and effectiveness of an investigational~     multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.~   "
163618|NCT01424176|"~     This is a multicenter, open-label, single-dose, PK and safety study in subjects with various~     stages of renal impairment.~   "
163619|NCT01424163|"~     This is a single and multiple dose, open-label study to evaluate the pharmacokinetics (PK),~     safety, and tolerability of dexpramipexole administered orally to adult Japanese and~     Caucasian healthy subjects.~   "
163620|NCT01424150|"~     The optimal fluid regimen, haemodynamic (or other) targets and fluid choice (colloid or~     crystalloid) for patients undergoing major surgery are based on rationales that are not~     supported by strong evidence. Practices vary substantially, guidelines are vague, small~     trials and meta-analyses are contradictory. The strongest and most consistent evidence, and~     biological plausibility because of tissue edema, supports a restrictive fluid strategy. But~     other evidence supports goal-directed therapy, requiring additional IV fluid. There is no~     good evidence that use and choice of colloids improves outcome. RELIEF will study the effects~     of fluid restriction, and the possible effect-modification of goal-directed therapy and~     colloids. The first will be randomly assigned; the latter will be measured covariates~     dictated by local practices and beliefs.~      Study Hypotheses A restrictive fluid regimen for adults undergoing major abdominal surgery~     leads to reduced complications and improved disability-free survival when compared with a~     liberal fluid regimen.~      Secondary hypothesis: The effects of fluid restriction are similar whether or not~     goal-directed therapy is used (assessed as a statistical test of interaction). A restrictive~     fluid regimen will reduce a composite of 30-day septic complications and mortality.~   "
163621|NCT01424137|"~     The purpose of this study is to characterise inspiratory flow parameters across 2 Easyhaler®~     (EH) inhaler versions and Diskus® inhaler in patients with asthma (including children,~     adults, and the elderly) and in patients with chronic obstructive pulmonary disease (COPD).~   "
163622|NCT01424124|"~     The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to~     singulair or placebo in patients (n=96) with partially controlled asthma.~      The study will conduct with 4 comparative groups orally treated with YHD001 dose level~     1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.~   "
163623|NCT01424111|"~     The purpose of this research is to explore objective biomarkers in voice, physiological,~     motor, and brain imaging signals that may one day be used to complement clinical evaluation~     and treatment of depression.~   "
163624|NCT01424098|"~     A growing body of evidence suggests that individuals with chronic lung disease have important~     deficits in balance control that may be associated with an increased risk of falls. The main~     purpose of this study is to examine the effects of a balance training program on measures of~     balance and fall risk in people with chronic lung disease.~   "
163625|NCT01424085|"~     The purpose of this study is to evaluate the use of antibiotics (i.e. Kefzol) before~     percutaneous gastrostomy performed in interventional radiology. Patient will be randomized to~     receive antibiotics or placebo before the procedure, and the rates of skin infection after~     the procedure will be determined between the two groups. This has never been studied in our~     population of patients undergoing the procedure. However, antibiotics are routinely given~     despite the lack of evidence. The investigators hypothesize that patient receiving~     prophylactic antibiotics will have a decreased number of infections compared to placebo.~   "
163626|NCT01424072|"~     This randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies~     in 75 nursing professionals in a University Hospital.~   "
163627|NCT01424059|"~     The purpose of this study is to evaluate the experience of labor in parous women induced~     because of fear of labor and, to compare the experience of parous women induced without fear~     of labor. A comparison with the experience of women delivered with elective cesarean section~     because of fear of labor is done.~      In the induced labors, the induction method is amniotomy. Between groups the experience of~     delivery is evaluated with a questionnaire: Wijma Delivery Expectancy Questionnaire(WEDQ-B).~      Groups are also compared with regard to time from induction to delivery and rate of operative~     delivery.~      Hypotheses:~        -  there is no difference in experience of delivery~        -  there is no difference in time to delivery or rate of operative deliveries~   "
163628|NCT01424046|"~     This study is a pilot 2-armed, randomized, open label, clinical trial evaluating the~     effectiveness of a basal approach to diabetes management as compared to the current standard~     treatment (regular/NPH).~      Patients seen at the Association Rwandaise des Diabetiques (ARD) will be invited to~     participate in the study and consent will be obtained by the investigation team. This will~     continue until 40 patients have been enrolled at which time recruitment will be started at a~     provincial hospital, at which 10 further participants will be recruited. Participants will be~     consenting to 1) Randomization to basal or current insulin treatment arm and 2) Permission~     for use of clinical data for research.Participants will be followed every six months for a~     period of 24 months. The first 6 months will be a wash in period and participants will be~     randomised (1/1) to their treatments at the 6 month visit.~   "
163629|NCT01424033|"~     The first objective of this protocol is to assess the tolerability and safety of~     N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung~     disease (CTD-ILD).~   "
163630|NCT01424020|"~     The purpose of this study is to test and validate a new questionnaire in order to get a~     walking estimated limitation calculated by history (WELCH) in patients referred for vascular~     investigations.~   "
163645|NCT01423825|"~     This is an extension of the HVTN 073/SAAVI 102 study. This study will evaluate the safety and~     immune response to an HIV envelope protein vaccine boost in people who have previously~     received the SAAVI DNA-C2 and SAAVI MVA-C vaccines or placebo in the HVTN 073/SAAVI 102~     study.~   "
163632|NCT01423994|"~     Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits,~     and probably is responsible for CDN $250 million in health care spending each year. It is~     associated with decreased quality of life, trauma, loss of employment, and limitations in~     daily activities. It is a particular problem for older people, partly because of increased~     frailty, and partly because of a difficult differential diagnosis. One of the causes in older~     adults is intermittent complete heart block in the setting of bifascicular heart block, but~     they may also faint due to a variety of tachyarrhythmias, sick sinus syndrome, and several~     neurally mediated syncopes. Often treatment decisions should be made before the true cause is~     apparent.~   "
163633|NCT01423981|"~     This trial intends to gather very basic clinical information about keloid, its patterns of~     presentation, family history, ethnic background and correlation with the type of keloid, as~     well as prior treatment results that patients have had received.~   "
163634|NCT01423968|"~     The investigators aim to examine how the skeletal muscles of the human volunteers respond to~     experimental septic conditions to aid understanding of muscle wasting and its biology..~      Six healthy men aged 18-30 will be randomly assigned to two metabolic study visits. On the~     first visit, while resting on a bed, they will have four cannulae inserted including one in~     the upper thigh, for blood sampling and the infusion of insulin, glucose and normal and~     tracer amino acids (which allow us to measure muscle protein metabolism). Subjects will~     receive either injection of purified bacterial product called lipopolysaccharide (LPS) to~     induce flu-like symptoms or normal saline according to randomization followed by a metabolic~     test to stimulate muscle synthesis and glucose transport. Three small samples of muscle will~     be obtained under local anaesthetic from the thigh to measure molecular events in muscle. By~     performing these measurements, the investigators will determine the consequences of LPS on~     muscle production and carbohydrate metabolism.~   "
163635|NCT01423955|"~     The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and~     degree of acute kidney injury after cardiac surgery.~   "
163636|NCT01423942|"~     The purpose of this study is to try to evaluate the maturation of the autonomic nervous~     system in prematures.~   "
163637|NCT01423929|"~     The aim of SOCCER is to evaluate the effects of treatment with supplemental O2 before and~     during acute balloon angioplasty (PCI) for patients with ST-elevation myocardial infarction~     (STEMI). One hundred STEMI patients are randomized in the ambulance to either standard O2~     treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI.~     Cardiac magnetic resonance imaging and echocardiography during the hospital stay is used to~     assess infarct size and myocardial performance. All patients are followed for 6 months. At 6~     months, perceived health and NT-proBNP are recorded for all patients, and an additional~     echocardiography is performed. The primary endpoint is the fraction of myocardium saved with~     the acute PCI. The secondary endpoints include the pain difference between inclusion time and~     start of PCI and myocardial performance on echocardiography.~   "
163638|NCT01423916|"~     The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and~     adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective~     subjects. The goals of this trial are three-fold:~        -  To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for~          placebo~        -  To determine the effect of moxifloxacin on QTcI~        -  To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI~   "
163639|NCT01423903|"~     The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given~     daily by mouth to subjects with advanced solid tumors.~   "
163640|NCT01423890|"~     A prospective population-based cohort study is being conducted in Ontario to evaluate whether~     the performance of Oncotype DX® changes the treatment recommended and the treatment received~     in women or men with node negative, ER positive breast cancer who are receiving (or will~     receive) endocrine therapy and who are candidates for chemotherapy. One thousand eligible~     consenting women and men will have their tumor tissue specimen sent to Genomic Health where~     the Oncotype DX® assay will be performed.~   "
163641|NCT01423877|"~     Specific Aims & Hypothesis Primary Aim: To evaluate laparoscopic bariatric surgery versus~     intensive medical weight management on indices of insulin resistance and resolution of type 2~     diabetes among patients with BMI 30-35.~      Hypothesis: Bariatric surgery is the most effective treatment to induce diabetes remission in~     obese diabetic patients BMI 30-35.~      The primary outcomes will be assessed at 6 months: (1) within-patient change in insulin~     resistance after either bariatric surgery or initiation of intensive medical weight~     management, and (2) remission of diabetes, (i.e., fasting glucose <126mg/dL and glucose~     <200mg/dL two hours after a standard 75g oral glucose load without the use of~     anti-hyperglycemic medications). Insulin resistance will be assessed at randomization and at~     6 months with the homeostatic model assessment of insulin resistance (HOMA IR) based on~     insulin and fasting glucose, as well as oral glucose tolerance tests with~     area-under-the-curve (AUC) measurement for insulin values. Medication discontinuation will be~     derived from electronic health records and patient self-report at 6 months. Secondary~     outcomes will include changes in HBA1c, weight, blood pressure, waist circumference, and~     levels of fasting lipids.~   "
163642|NCT01423864|"~     Acute respiratory distress syndrome (ARDS) in combination with multi-organ dysfunction~     syndrome (MODS) is a life-threatening condition, particularly when treatment modalities such~     as extracorporeal membrane oxygenation (ECMO) and catecholamine administration have failed to~     treat the severe condition. In this study, the investigators report patients who responded to~     intrapleural steroid instillation (IPSI) while being unresponsive to conventional treatment~     (use of intravenous steroids, nitric oxide inhalation, high-frequency oscillatory~     ventilation, or ECMO) for treatment of critical illnesses such as ARDS in combination with~     MODS.~   "
163643|NCT01423851|"~     The purpose of this study is to determine the safety and tolerability of orally administered~     NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis~     (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)~   "
163644|NCT01423838|"~     Null hypothesis of the trial is that there is no difference between solifenacin and~     oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life~     measures in patients with overactive bladder.~   "
163757|NCT01422369|"~     This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug~     interaction study.~   "
163646|NCT01423812|"~     Darunavir is a nonpeptidic protease inhibitor with a high genetic barrier to resistance that~     evolved from a prototype compound synthesized using structure-based design strategies.~     Once-daily darunavir at 800mg boosted with 100mg of ritonavir is an effective antiretroviral~     agent indicated for HIV-infected treatment-naïve patients. In treatment-experienced patients,~     darunavir was initially approved for twice-daily administration boosted with twice-daily~     ritonavir at 600mg and 100mg, respectively. Recently, once-daily darunavir/ritonavir was~     approved for use in treatment-experienced adult patients with viremia with no darunavir~     resistance mutations. In treatment-experienced patients with viral suppression, switching~     from an antiretroviral taken twice-daily to a once-daily dose is an attractive option to~     promote greater patient acceptability and adherence, and potentially minimize side effects~     and toxicities. Because of darunavir/ritonavir's high genetic barrier to resistance and~     well-established safety profile at a once-daily dose, switching patients with virologic~     suppression from twice-daily darunavir/ritonavir to once-daily darunavir/ritonavir will~     likely confer attributes more favorable to patients through a simplified dosing schedule and~     lower potential for lipid elevation without the loss of virologic control. DRIVESHAFT is a~     48-week Phase 4, randomized, open label, comparative study. The study will be conducted in 60~     HIV-1 infected, antiretroviral experienced, virologically-suppressed patients on regimens~     containing darunavir 600mg/ ritonavir 100mg twice-daily and a minimum of two other~     antiretrovirals, with a history of 0-1 darunavir-associated resistance mutations. Subjects~     will be randomized 1:1 to switch to darunavir 800mg/ ritonavir 100mg once-daily or continue~     on their current regimen. Rates of virologic suppression of once-daily darunavir/ritonavir~     regimens relative to darunavir/ritonavir twice-daily regimens will be compared, and safety,~     change from baseline fasting lipid parameters, and adherence will be evaluated.~   "
163647|NCT01423799|"~     The purpose of this study is to compare the health-related quality of life following dietary~     supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet~     supplement in patients suffering from upper digestive tract neoplasia undergoing oncological~     treatment.~   "
163648|NCT01423786|"~     This is a prospective trial for children with the diagnosis of mild acute pancreatitis~     admitted to the hospital for continued management. Patients will be enrolled in the study~     within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled.~     Demographic, laboratory and imaging data done as standard of care will be collected and~     additional blood work will be sent as part of the study. Patients will be followed~     prospectively with regards to tolerance to oral nutrition, pain, length of stay and~     complications. The hypothesis is that patients that are able to tolerate early oral nutrition~     will have shorter length of stays and will be similar in terms of pain score ratings,~     readmission rates, complications and the need for invasive supplemental nutrition. Also~     patients that are able to tolerate early oral nutrition will have less significant elevation~     of biochemical markers of pancreatitis severity when compared to patients that do not~     tolerate early oral nutrition and historical controls.~   "
163649|NCT01423773|"~     The purpose of this study was to compare the fit and comfort of two types of contact lenses.~   "
163650|NCT01423760|"~     This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA,~     EMD Serono or Merck Serono Japan sponsored trial with tecemotide (L-BLP25) were enrolled in~     this follow-up trial to continue their maintenance treatment with tecemotide (L-BLP25).~     Subjects were transferred once the feeder trial (EMR 63325-005 [NCT00157209], EMR 63325-006~     [NCT00157196] and EMR 63325-008 [NCT01094548]) objectives were met. Subjects who received~     tecemotide (L-BLP25) in a feeder trial continued tecemotide (L-BLP25) treatment in this~     follow-up trial and have safety assessments performed as well as were observed for~     progressive disease (PD) and survival in 6- month intervals. Subjects who had not received~     tecemotide (L-BLP25) in feeder trials, or discontinued treatment were only observed for PD~     and survival in 6-month intervals and were not provided treatment with tecemotide (L-BLP25).~   "
163651|NCT01423747|"~     With this protocol the ALL-SZT BFM international study group wants~      to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or~     unrelated matched donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).~      to evaluate the efficacy of haematopoietic stem cell transplantation (HSCT) from mismatched~     family or unrelated mismatched donors (MMD) as compared to HSCT from matched sibling donor~     (MSD) and matched donor (MD).~      to determine whether therapy has been carried out according to the main haematopoietic stem~     cell transplantation (HSCT) protocol recommendations. The standardisation of the treatment~     options during haematopoietic stem cell transplantation (HSCT) from different donor types~     aims at the achievement of an optimal comparison of survival after HSCT with survival after~     chemotherapy only.~      to prospectively evaluate and compare the incidence of acute and chronic graft-~     versus-host-disease (GvHD) after haematopoietic stem cell transplantation (HSCT) from matched~     sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).~   "
163652|NCT01423734|"~     Imaging with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) is normally used to~     see how tumors respond to treatment. If tumors shrink after therapy, doctors continue with~     the same treatment. On the other hand, growing tumors in a patient can bring about a change~     in therapy. Unfortunately, it often takes three to six months, or even longer before the~     investigators see tumors shrink or grow on scans. Doctors are looking for new imaging tools~     that can look at how tumors respond early on during treatment. This study will help us decide~     if such an MRI technology called DWI (Diffusion Weighted Imaging) can be used as a helpful~     imaging tool.~   "
163653|NCT01423721|"~     The objective of the current study is to investigate relative bioavailability of bromhexine~     hydrochloride given as granules and syrup~   "
163654|NCT01423708|"~     Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.~   "
163655|NCT01423695|"~     The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of~     advanced breast cancer based on a large pivotal study. However, mono and combination~     chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially~     in the palliative setting. The present trial examines the efficacy and safety of weekly~     paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.~   "
163665|NCT01423565|"~     HYPOTHESIS: Constant current stimulation for STN DBS will allow better and more stable~     control of Parkinson's disease symptoms than constant voltage stimulation.~      Subthalamic nucleus (STN) deep brain stimulation (DBS) is an established therapy for advanced~     Parkinson's disease (PD). Two types of implantable pulse generators (IPGs) are available,~     differing on whether voltage or electrical current is controlled. Constant current IPGs~     provide a specific electrical current and will automatically adjust the voltage depending on~     the impedance, while the current applied by constant voltage IPGs will depend on the tissue~     impedance that may change over time. No study has compared the clinical differences of these~     two electronic modalities.~   "
163850|NCT01421147|"~     The purpose of this study is to compare the effectiveness and safety of LY2963016 versus~     Lantus when taken once daily in combination with insulin lispro before meals three times a~     day.~   "
163656|NCT01423682|"~     Patients with rotator cuff tendinopathy make up a large part of the population in~     physiotherapy practice. The rotator cuff, a shoulder muscle group, plays an important role in~     causing pain. Tendons suffer large compression and friction, which can lead to degeneration~     of these tendons. Rehabilitation often leads to unsatisfying results.~      In Achilles and patella tendinopathy, a new training program called eccentric training has~     shown very good results. Eccentric training contains exercises during which a force has to be~     resisted while the muscle lengthens instead of shortens. This would have a larger influence~     on tendon tissue. Some small studies also show promising results of eccentric training in~     patients with rotator cuff tendinopathy but the mechanisms behind these results remain~     unclear.~      To investigate this, 30 patients with rotator cuff tendinopathy and 30 healthy subjects will~     be evaluated before and immediately after performing the exercise. Three measurements will be~     done: ultrasonographic measurement of tendon thickness, power Doppler imaging and measurement~     of microcirculation around the tendon with Oxygen to see. All measurements are non-invasive,~     pain free and without risks for the human body.~   "
163657|NCT01423669|"~     Purpose Psychotic disorders (including schizophrenia) are complex neurobehaviour disorders~     influenced by genetic, neurodevelopmental, neurochemical, as well as psychosocial factors.~     Despite significant progresses in pharmacotherapy, the disorder often results in long-term~     disability (ranked globally amongst the top ten leading causes of disability-adjusted life~     years, DALYS), often associated with extensive cost, burden, morbidity and mortality.~      Objective / hypothesis The study aims to (1) measure the prevalence of psychotic symptoms in~     the Hong Kong population; (2) explore associated risk and protective factors for the~     expression of psychotic symptoms; (3) characterize the functional disability in people with~     psychotic symptoms; and (4) study the determinant of clinical presentation or~     non-presentation in people with psychotic symptoms.~      Design, subjects and study instrument The survey will be conducted with a two-phase design.~     The first phase interviews will include approximately 5,000 subjects with structured~     assessments serving diagnostic criteria for CMD, screening instruments for psychotic~     disorder, substance misuse and suicidal behaviours, functioning, service use and~     demographics. The second phase comprises of clinician interviews for psychotic disorder and~     at risk mental state and other variables including neurocognitive, help seeking, stigma and~     well-being.~      Analysis Prevalence estimates will be weighted, expressed as rates and confidence intervals.~     Comorbidity will be estimated using Latent Class Analysis (LCA) Logistic regression will be~     used to identify significant factors associated with mental disorders.~   "
163658|NCT01423656|"~     The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data~     when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.~      The study is divided into one single dose part, one part to compare pharmacokinetics between~     gender and one multiple dose part.~   "
163659|NCT01423643|"~     The chief purpose of this research is to understand how antiretroviral therapy (ART) affects~     progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The~     investigators study liver disease progression in a cohort of dually infected persons~     according to the success of ART.~   "
163660|NCT01423630|"~     Probiotics and fruit fibre are given for 12 weeks to patients with fatty liver disease.~      The hypothesis is that probiotic bacteria and fruit fibre affect the gut microbial~     composition in a positive manner. The improved ecological system is believed to contribute to~     improved liver health and thereby counteract fatty liver disease.~   "
163661|NCT01423617|"~     The intention of the study is to evaluate the safety and potential body weight and body fat~     loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind,~     placebo-controlled, parallel study conducted in Caucasian subjects.~      This study will also include a diet plan for each subject, calculated based on gender, age,~     and energy requirements; and adjusted to be slightly hypocaloric.~   "
163662|NCT01423604|"~     The purpose of this study was to determine whether ruxolitinib added to capecitabine is~     effective in improving the overall survival of patients with metastatic pancreatic cancer.~   "
163663|NCT01423591|"~     Rheumatic Polymyalgia(PMR) is a relatively common chronic inflammatory disorder of unknown~     origin which predominantly develops in elderly subjects and presents with severe pain and~     stiffness in the neck, shoulder and pelvic girdles, along with increased acute phase~     reactants. Systemic manifestations such as fever, anorexia and weight loss are characteristic~     signatures of PMR.~      Corticosteroids (CS) constitute the standard treatment of PMR. Although in most patients the~     symptoms of the disease disappear after one or two years of treatment, a proportion of~     patients remain CS-dependent with the subsequent CS toxicity. Open label studies have~     suggested that tumour necrosis factor (TNF) antagonists lead to sustained improvement and CS~     sparing effect in patients with refractory PMR.~      The investigators conducted a randomised, double-blind, placebo controlled trial with~     infliximab in CS-dependent patients with PMR. Patients with CS-dependent PMR (defined as~     requiring ≥ 5 mg/day after at least 2 years of treatment to maintain remission or ≥ 7.5~     mg/day after at least 6 months) were randomly assigned to receive Infliximab (5 mg/kg i.v) at~     0, 2, 6, 14 and 22 weeks (n = 12) or placebo (n = 11) together with CS that were reduced~     according to a predefined schedule. The primary outcome was the proportion of responder~     patients -defined as individuals with both complete clinical and analytical remission without~     receiving CS for at least three months- at 24 weeks. Secondary outcomes were cumulative CS~     doses and adverse events proportion.~   "
163664|NCT01423578|"~     The overall purpose of this pilot study is to examine effects of Hatha yoga and~     cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our~     preliminary study indicated that a single session of either form of activity intervention~     improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed~     study will extend this preliminary research in several ways.~   "
163677|NCT01423409|"~     The purpose of this study is to assess an innovative Visual Analogue Scale of pain (pictorial~     VAS) versus the usual VAS (VAS) among Deaf People.~      The assumption of this study is that pictorial VAS is more suited to Deaf people than usual~     VAS.~   "
163851|NCT01421134|"~     Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with~     mixed features.This clinical study is designed to test how well Lurasidone works to treat~     major depressive disorder with mixed features.~   "
163666|NCT01423552|"~     The ongoing success of transplantation is largely due to the development of drugs to stop the~     patient's body from rejecting the new organ. In addition to steroids, two main types of drug~     are used to suppress the immune system following heart transplantation: calcineurin~     inhibitors (Ciclosporin-A or Tacrolimus) and mycophenolate. However, different patients~     respond in different ways to these drugs, with the same dose leading to different levels of~     the drug in the blood. This varies due to genetic and other factors such as age, kidney~     function and the use of other drugs. Therefore, the levels of immunosuppressive drugs in the~     blood are routinely measured and the dose adjusted accordingly. However, some patients still~     experience episodes of rejection despite apparently acceptable levels. In this study, the~     investigators will measure levels of the drugs (in the blood, in a type of white blood cell~     called T-cells and in the heart muscle) and the effectiveness of the drugs on T-cells. The~     investigators will compare these levels with patient genetic factors and the amount of~     rejection measured on heart biopsies. This will enable us to better understand how the blood~     and tissue levels of these drugs change with genetic and other factors in order to optimise~     immunosuppressive therapy and further improve outcomes from heart transplantation.~   "
163667|NCT01423539|"~     This randomized, open-label, multicenter study will evaluate the efficacy and safety of~     navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large~     B-cell lymphoma. Patients will be randomized to receive navitoclax in addition to~     bendamustine and rituximab or bendamustine and rituximab alone for 6 cycles.~   "
163668|NCT01423526|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics of orally administrated DWP10292 in healthy male volunteers.~   "
163669|NCT01423513|"~     The purpose of this study is to examine the effects of ankle taping on improving muscle~     function and ankle motion in individuals who frequently twist (sprain) their ankle. It is~     thought that ankle taping may increase muscle function and ankle motion which would benefit~     individuals who frequently sprain their ankle.~   "
163670|NCT01423500|"~     With this protocol the ALL-SCT BFM international study group wants~        -  to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family~          or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).~        -  to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from~          mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling~          donors or matched donors.~        -  to determine whether therapy has been carried out according to the main HSCT protocol~          recommendations. The standardisation of the treatment options during HSCT from different~          donor types aims at the achievement of an optimal comparison of survival after HSCT with~          survival after chemotherapy only.~        -  to prospectively evaluate and compare the incidence of acute and chronic~          Graft-versus-Host-Disease (GvHD) after HSCT from matched sibling donor (MSD), from~          matched donor (MD) and from mismatched donor (MMD).~   "
163671|NCT01423487|"~     Some previous studies has demonstrated that Metformin can improve the weight gain which~     caused by antipsychotics. An our study, which will be published, also found that Metformin~     can improve the amenorrhea for patients with antipsychotics, approximately 60% patients~     recovery period. So the present study was designed to investigate the efficacy and safety of~     Metformin in preventing patients with Risperidone from weight gain and amenorrhea.~   "
163672|NCT01423474|"~     The purpose of this study is to compare the toxicity of two new radiation schedules for the~     treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered~     every other day over 11 days, or once per week over 29 days. Both of these schedules are~     shorter than the standard treatment which is usually 39 treatments over 8 weeks.~   "
163673|NCT01423461|"~     Individualized health care refers to the development of strategies for disease management~     and health promotion that are informed by specific data on genetics and physiological~     processes that uniquely determine each person's health profile and potential responsiveness~     to interventions or susceptibility to environmental exposures.~      Asthma, an inflammatory disorder of the airway, appears to be determined by multiple~     interacting genetic and environmental factors. Such risk factors include allergic responses,~     small airways, excess body weight, specific properties of airway smooth muscle, airway and~     generalized metabolic and inflammatory homeostasis, and exposures to environmental irritants,~     allergens, and psychosocial stressors. To date, asthma treatment strategies have been guided~     by severity guidelines rather than by characteristics of the child's specific phenotype (a~     child's underlying allergic tendency, extent of airway inflammation and airway smooth muscle~     dysfunction, or underlying obesity and metabolic perturbations). The growing availability of~     new classes of asthma medications that more directly target specific pathophysiological~     derangements will require accessing data on each child's asthma risk profiles to optimize~     selection of medications and other interventions that most specifically address the~     underlying pathophysiology while minimizing adverse treatment side effects.~      The investigators propose to develop a model program for collecting relevant clinical~     information and genetic data on a high risk group of asthmatic children, including data on~     common co-morbidities, specifically obesity and sleep disorders; use this information to~     develop a comprehensive model database for characterizing children according to their health~     profiles; and use this characterization to initiate targeted interventions, while continuing~     long term follow up of these children to determine differential responsiveness to~     medications.~   "
163674|NCT01423448|"~     This study is a randomised controlled trial that aims to examine the efficacy of an~     established online bulletin board for depression. It has been estimated that millions of~     people worldwide use peer-to-peer bulletin boards, forums or internet support groups (ISGs)~     for health conditions. However, little is known about the effectiveness of these groups in~     terms of symptom reduction or improvement in quality of life. The current project~     investigates the effectiveness of an established online bulletin board for depression~     available to the public. To our knowledge, this is the first randomised controlled trial of~     the effectiveness of a pre-existing, well-established online bulletin board for depression in~     the community. The aims of the project are to determine whether the bulletin board improves~     mental health, quality of life, and related outcomes among members of the community with high~     levels of self-reported psychological distress and previous history or current experience of~     depression.~   "
163675|NCT01423435|"~     A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and~     South Korean non-elderly healthy adult males.~   "
163676|NCT01423422|"~     The investigators have previously shown that a frequency of 15.95-16.00 Hz protects against~     acute myocardial infarction in rats. In the current study the investigators would like to~     investigate whether this frequency enables cardiac patients with exercise-induced chest pain~     to exercise at higher workload and heart rate. Therefore, patients will undergo two exercise~     stress tests, one test after being exposed to 30 minutes of the above mentioned frequency and~     another test after being exposed to sham (no frequency is turned ON). The investigators will~     measure changes in the electrocardiogram (ECG), workload, exercise time, and subjective~     measure of chest pain (angina).~   "
163678|NCT01423396|"~     Three quarters of patients with Alzheimer's disease have at least one vascular risk factor~     (VRF). Vascular brain lesions are present in most Alzheimer's patients (especially older~     ones). This cerebrovascular disease potentiates Alzheimer's lesions in early-stage disease.~     Many research studies have shown that VRFs are also risk factors for Alzheimer's disease;~     this is true for arterial hypertension and dyslipidaemia in particular and, to a lesser~     extent, diabetes and cardiopathy. Moreover, recent drug trials (SYST-EUR, PROGRESS and HOPE)~     have indicated that antihypertensive medications can prevent the appearance of dementia (and~     notably Alzheimer's disease) in over-60 hypertensive subjects. An observational study of 233~     Alzheimer's patients with an average follow-up period of 4 years has shown that the annual~     decline in the Mini-Mental State Examination (MMSE) score was lower in patients in whom all~     the VRFs were being treated than in patients in whom no VRFs were being treated (1.5 ± 2.5~     points versus 2.5 ± 2 points, respectively; p<0.04).1 However, it is not currently known~     whether optimal treatment of VRFs can influence the progression and prognosis of Alzheimer's~     disease. Answering this question could have a significant impact on public health.~   "
163679|NCT01423383|"~     Although keloid is a very common condition; there are no statistics as to its true incidence~     and prevalence, neither in United States, nor elsewhere in the world. This trial intends to~     capture epidemiological data about this disease in a large population sample.~   "
163680|NCT01423370|"~     The objective of this study is to assess the safety and efficacy of oral YHD1023 5g or 10g on~     erectile dysfunction to investigate the optimal recommended dosage. Study period is 12 weeks~     including 4weeks of follow-up period without treatment. Study patients will fill in the~     international index of erectile function questionnaire and life satisfaction questionnaires.~   "
163681|NCT01423357|"~     The aim of this study is to investigate whether distribution of condoms and condom~     demonstrations by youth peer educators in venues where people meet new sexual partners in~     Livingstone, Zambia, leads to increased condom use among guests socializing in these venues.~   "
163682|NCT01423344|"~     Background: in patients with multiple myeloma there is a raised level of a protein, named~     M-protein. This M-protein is normally used to monitor disease status and evaluate response to~     treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. However,~     the M-protein has a long half life in serum, approximately three weeks, which tend to be a~     practical problem, since the investigators can first determine hereafter if the treatment is~     effective.~      A new assay has the possibility only to measure part of this protein, namely the light~     chains, which also is measured in a blood sample. The half life of these light chains is~     much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a~     given treatment, thereby being able to determine earlier if the treatment should continue or~     changed to another strategy.~      Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum~     free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under~     treatment for multiple myeloma.~      Method: the investigators measure sFLC in patients receiving there 1st treatment, either at~     the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the~     results are compared to the M-protein.~   "
163683|NCT01423331|"~     An Evaluation and Factor Analysis for Maternal Mental Health - The Analytic Study of the Shin~     Kong Wu Ho-Su Memorial Hospital~      - Objectives：~        1. To construct a screening tool for domestic maternal mental health~        2. To expect to find the screening timing for early assessment or intervention of domestic~          maternal mental health status.~        3. To explore the impact of domestic maternal mental health factors.~   "
163684|NCT01423318|"~     This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the~     safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers.~     Healthy Japanese and Caucasian volunteers will be randomized to receive a single subcutaneous~     dose of either lebrikizumab or placebo.~   "
163685|NCT01423305|"~     The objective of the study is to assess if charcoal prevents the absorption of budesonide and~     formoterol via GI track. The assessment will be based on comparing the pharmacokinetic~     parameter area under the concentration-time curve.~   "
163686|NCT01423292|"~     The purpose of this study is to determine whether the transversus abdominis plane (TAP)~     blocks are effective in postoperative pain control of adult patients undergoing laparoscopic~     colectomy.~   "
163687|NCT01423279|"~     This research is NOT part of an interventional trial, however the investigators use umbilical~     cord after birth for isolating endothelial and smooth muscle cells for academic research.~   "
163688|NCT01423266|"~     This research project was designed to study the role of dietary modifications in heart~     failure (HF) patients that suffer from type 2 diabetes mellitus and obesity. Specifically,~     the purpose of this study is to determine whether or not heart failure patients participating~     in a 3-month intensive lifestyle modification program of either a high protein (30 % of total~     calories from protein) group will have a significant improvement in weight reduction, quality~     of life and clinical outcomes compared to a standardized protein (15% of total calories from~     protein) group.~   "
163689|NCT01423253|"~     Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with~     mixed features.This clinical study is designed to test how well Lurasidone works to treat~     major depressive disorder with mixed features over time.~   "
163690|NCT01423240|"~     Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with~     mixed features.This clinical study is designed to test how well Lurasidone works to treat~     major depressive disorder with mixed features.~   "
163701|NCT01423097|"~     Estimate the prevalence of self-reported osteoarthritis and its characterization in adults~     over 45 years of age:~        -  Characterization of self-reported patients with OA (socio-demographic, comorbidities,~          VAS for intensity of pain)~        -  Characterization of OA diagnosis in patients with self-reported OA~        -  Impact of self-reported OA in the working abilities, quality of life and functionality~          (SF-12 v2.0)~        -  Characterization of treatment approaches (therapeutic and non-therapeutic) for~          self-reported patients with OA~        -  Patient perception of impact of OA in its life and importance given to disease~   "
163852|NCT01421121|"~     A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and~     immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.~   "
163691|NCT01423227|"~     Pulmonary rehabilitation is an effective treatment for people with chronic obstructive~     pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers~     healthcare costs. However less than 1% of Australians with COPD receive pulmonary~     rehabilitation each year, due to poor access to programs and high levels of disability. This~     randomised controlled trial will examine the benefits and costs of a novel, entirely~     home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based~     pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the~     centre-based program.~      We will randomly allocate 144 people with COPD to undertake either standard pulmonary~     rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake~     pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for~     eight weeks for supervised exercise training and education. People in the home pulmonary~     rehabilitation group will receive one home visit and weekly telephone calls for eight weeks,~     for supervision and mentoring of exercise and provision of education. We will compare the~     number of people who complete the program in each setting. We will also test whether the~     groups have similar results for the standard pulmonary rehabilitation outcomes of~     breathlessness, quality of life and exercise capacity, at the end of the program and 12~     months later. We will compare health care costs and personal costs between groups after 12~     months.~      If home-based pulmonary rehabilitation can improve uptake of this important treatment,~     deliver good clinical outcomes and reduce costs this will have significant and long-lasting~     benefits for patients, the community and the health system~   "
163692|NCT01423214|"~     This study sets up the final study end point and three detailed goals as the following.~      The main objective of study: This trial is done to assess the safety and benefit of robotic~     resection compared with conventional laparoscopy-assisted resection for curative treatment of~     patients with cancer of the mid or low rectum.~      Detailed goal of study:~      The primary endpoint: This study is designed to assess whether robotic surgical system~     improves the quality of rectal cancer surgery, especially in total mesorectal excision~     quality and a circumferential margin positivity rate~      The secondary endpoint: This study aims to compare 3- and 5-year disease-free survival and~     overall survival after robot and laparoscopic resection of distal rectal cancer. This study~     will also assess the pelvic autonomic nerve preservation, short-term morbidity, pathological~     quality (i.e. number of harvested lymph node), local recurrence, and blood loss during~     surgery.~   "
163693|NCT01423201|"~     Transient ischemic attack (TIA) is a transient neurological deficit (speech disturbance,~     weakness…), caused by temporary occlusion of a brain vessel by a blood clot that leaves no~     lasting effect.~      TIA diagnosis can be challenging and an expert stroke evaluation combined with magnetic~     resonance imaging (MRI) could improve the diagnosis accuracy.~      The risk of a debilitating stroke can be as high as 5% during the first 72 hrs after TIA.~      TIA characteristics (duration, type of symptoms, age of the patient), the presence of a~     significant narrowing of the neck vessels responsible for the patient's symptoms (symptomatic~     stenosis), and an abnormal MRI are associated with an increased risk of stroke.~      An emergent evaluation and treatment of TIA patients by a stroke specialist could reduce the~     risk of stroke to 2%.~      Stanford has implemented an expedited triage pathway for TIA patients combining a clinical~     evaluation by a stroke neurologist, an acute MRI of the brain and the vessels and a sampling~     of biomarkers (Lp-PLA2). The investigators are investigating the yield of this unique~     approach to improve TIA diagnosis, prognosis and secondary stroke prevention. The objective~     of this prospective cohort study is to determine which factors will help the physician to~     confirm the diagnosis of TIA and to define the risk of stroke after a TIA.~   "
163694|NCT01423188|"~     This study is designed to provide an assessment of the change in baseline lipid parameters~     with RVX000222 after 12 weeks and 24 weeks of treatment when given in addition to optimized~     statin background therapy in subjects with low baseline HDL-C.~   "
163695|NCT01423175|"~     ClAraC (consisting of one dose of clofarabine and ara-C for five days) or FLAMSA (consisting~     of one dose of fudarabine, amsacrine and ara-C for four days) will be administered followed~     by reduced-intensity conditioning regimen (RIC) in the setting of allogeneic stem cell~     transplantation (SCT). The aim of the study is to explore the antileukemic, immunosuppressive~     effects and toxicity and safety of clofarabine in combination with ara-C in the setting of~     RIC allogeneic transplantation compared with the FLAMSA-protocol for patients with high-risk~     acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS).~   "
163696|NCT01423162|"~     This study will follow a double blinded randomized controlled study design to enroll 20~     apparently healthy 6 year old children. The children will be fed with two different nutrient~     fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA).~     Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for~     stable isotope measurements and iron absorption will be calculated.~   "
163697|NCT01423149|"~     The objectives of this study are to evaluate the safety and efficacy of 3 dose groups (27, 36~     and 45 mg/m2) of Combretastatin A-4 Phosphate for the treatment of subfoveal choroidal~     neovascularization in subjects with pathologic myopia.~   "
163698|NCT01423136|"~     In moderate to high risk patients, cardiovascular complications after surgery account for~     almost 60% of death after surgery. This study will randomize 140 patients into routine postop~     care with Holter monitoring versus routine postop care + remote ST monitoring + Holter~     monitoring. The response time to electrocardiographic (ECG) ST changes as well as the total~     ischemia time will be studied.~   "
163699|NCT01423123|"~     The FB-8 study is designed as an open label, single arm, Phase I dose-escalation study~     evaluating the combination of weekly paclitaxel with neratinib and trastuzumab in women with~     metastatic, HER2-positive breast cancer. The primary aim of this study is to determine the~     safety and tolerability of the three-drug combination.~   "
163700|NCT01423110|"~     This study will assess the efficacy, safety and tolerability of BYM338 in patients with~     sporadic Inclusion Body Myositis~   "
163702|NCT01423084|"~     The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1~     to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum~     bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup~     B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean~     concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary~     vaccination course of two doses administered one month apart.~   "
163704|NCT01423058|"~     The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential~     thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite~     of clonal disorders of pluripotent hematopoietic stem cells (Tefferi et al., 2008). The MPN~     share a range of biological, pathological, and clinical features including the relative~     overproduction of one or more cells of myeloid origin, growth factor independent colony~     formation in vitro, marrow hypercellularity, extramedullary hematopoiesis, spleno- and~     hepatomegaly, and thrombotic and/or hemorrhagic diatheses (Tefferi et al., 2005).~      This is a multi-centre, open-label, non-randomized, dose-escalation study, to be conducted in~     two phases: a dose-escalation phase (Part 1), to determine the safety and tolerability of~     momelotinib (CYT387), and to identify a therapeutic dose for the expanded cohort; and a~     dose-confirmation phase (Part 2), which will be a cohort expansion at or below the MTD of~     momelotinib.~      In the Part I dose-escalation phase of the study, subjects will be assigned to dose levels in~     successive cohorts starting with a dose in the first cohort of 200 mg BID (twice daily with~     doses taken approximately 12 hours apart). Doses will be escalated by 50 mg BID per cohort~     until dose-limiting toxicities are observed. The dose level at which ≥2 of 6 subjects develop~     a first cycle dose-limiting toxicity (DLT) is defined as the DLT level. The maximum tolerated~     dose (MTD) is defined as the dose level below the DLT level. New dose levels may begin~     accrual only if all subjects at the current dose level have been observed for a minimum of 28~     days from the first day of treatment. The dose level chosen for study in the dose~     confirmation phase of the study will be the MTD or a lower dose shown to have significant~     clinical activity (efficacy) as determined by the safety review committee. Subjects will be~     evaluated weekly for the first cycle, every 2 weeks during cycle 2, then monthly for 4 cycles~     for a total of 6 cycles.~      In the dose-confirmation phase of the study, approximately fifty (50) subjects will be~     treated at the MTD or at a lower dose shown to have significant clinical activity (efficacy)~     as chosen by the Safety Review Committee. In the dose confirmation phase of the study~     subjects will be evaluated every 2 weeks during the first treatment cycle, and then monthly~     for 5 cycles for a total of 6 cycles.~   "
163705|NCT01423045|"~     The study hypothesis is that urine concentrating ability can predict the rate of kidney~     function decline.~      Patients with kidney disease at the investigatorsclinic will be asked to give first morning~     urine sample and osmolarity will be measured. The investigators will follow up kidney~     function decline and check if there is association with urine osmolarity.~   "
163706|NCT01423032|"~     Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to~     its unique mechanism of action distinct from standard alkylating agents. This study assesses~     its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in~     comparison to fludarabine.~      Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous~     systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine~     100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of~     25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior~     progression-free survival with bendamustine.~   "
163707|NCT01423019|"~     The purpose of this study is to determine whether subjects taking a supplement designed to~     increase metabolic rate will have a positive effect on body composition (fat mass, muscle~     mass, and bone density.)~   "
163708|NCT01423006|"~     This is a prospective pilot study. The purpose of this research study is to evaluate the~     safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically~     localized prostate cancer.~   "
163709|NCT01422993|"~     The purpose of this study is to evaluate the effects on strength, balance, and neuropathic~     symptoms (numbness, tingling, pain, weakness) of a 12 week, bi-weekly, 60 minute, group~     exercise program designed to improve lower extremity strength and balance with persons with~     oxaliplatin induced peripheral neuropathy.~   "
163710|NCT01422980|"~     The purpose of this study is to determine whether the consumption of test dairy products is~     effective in reducing upper gastric discomfort after 2 weeks of product consumption.~   "
163711|NCT01422967|"~     Osteoarthritis (OA) is one of the major health problems and their prevalence has increased in~     recent decades. It has been shown that OA causes negative effects on sleep and that these~     changes in sleep see to be correlated with the function and physical performance of patients~     with OA. However, no study to date has demonstrated the effects of sleep changes in~     sensorimotor control and systemic inflammatory response in patients with OA. The objective of~     this study is to assess the influence of sleep changes in sensorimotor control (postural and~     neuromuscular control) and inflammatory markers (cytokines) in patients with knee OA grade I~     or II. Participate in this study, 60 male volunteers, aged between 40 and 65. These~     volunteers will be divided into four groups: Group 1 (n = 15): Osteoarthritis and good~     quality sleep, Group 2 (n = 15): Osteoarthritis and poor quality sleep, Group 3 (n = 15):~     Without good and Osteoarthritis quality of sleep, Group 4 (n = 15): Without Osteoarthritis~     and poor quality of sleep. All volunteers will perform a polysomnography to detect the~     presence or not of changes in sleep. Further testing on the isokinetic dynamometer to~     evaluate the acceleration time, maximum isometric torque and isokinetic concentric and~     eccentric maximum quadriceps muscle strength and a submaximal test to evaluate neuromuscular~     control. Also there will be a test on the force platform to assess the uni-and bipedal~     postural control, as well as respond to the WOMAC questionnaire that assesses the quality of~     life in patients with OA. Blood will be collected for analysis of inflammatory cytokines~     (TNF-alpha, IL-1alpha, IL-1beta, IL-6, IL-8, IL-12, IL-10, TGF-beta). The significance level~     is 5% (p ≤ 0.05).~   "
163712|NCT01422954|"~     Malaria is one of the major infectious diseases in the world with a tremendous impact on the~     quality of life, significantly contributing to the ongoing poverty in endemic countries. It~     causes 800.000 deaths per year, the majority of which are children under the age of five. The~     malaria parasite enters the human body through the skin, by the bite of an infected mosquito.~     Subsequently, it invades the liver and develops and multiplies inside the hepatocytes. After~     a week, the hepatocytes burst open and the parasites are released in the blood stream,~     causing the clinical phase of the disease.~      As a unique opportunity to study malaria immunology and efficacy of immunisation strategies,~     a protocol has been developed in the past to conduct controlled human malaria infections~     (CHMIs). CHMIs generally involve small groups of malaria-naïve volunteers infected via the~     bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although potentially~     serious or even lethal, P. falciparum malaria can be radically cured at the earliest stages~     of blood infection when risks of complications are virtually absent.~      The investigators have shown previously that healthy human volunteers can be protected from a~     malaria mosquito (sporozoite) challenge by immunization with sporozoites (by mosquito bites)~     under chloroquine prophylaxis (CPS immunization). Interestingly, sterile protection in 100%~     of the human CPS immunized volunteers was achieved by a relatively miniscule dose, i.e. a~     total of 45 infectious mosquito bites, strikingly 20-fold more potent than the 1000 bites~     needed in a model using irradiated mosquitoes. One possible explanation for this efficient~     induction of protective immunity, is the immune modulating effect of chloroquine. The~     investigators aim to assess this possible immune modulating effect in CPS immunization by~     comparing immunization with P. falciparum sporozoites under chloroquine with immunization~     under mefloquine prophylaxis, which has the same antimalarial effect, but not the immune~     modulating effects known from chloroquine.~   "
163713|NCT01422941|"~     The objectives of this clinical research project are to demonstrate the safety and~     feasibility of CAVU Medical, Inc.'s Attune Device.~   "
163853|NCT01421108|"~     This study explores the effectiveness of message framing, loss-framed vs. gain-framed~     messages on oral health in Iran.~   "
163714|NCT01422928|"~     Purpose/Goal: To investigate how long course radiation therapy (RT), both with or without~     chemotherapy, affects the immune system, and to determine if acupuncture can modify these~     effects in patients undergoing curative radiation therapy for gastrointestinal (GI) or~     genitourinary (GU) cancers.~      Clinical or Research Questions:~        1. Does RT reduce immune biomarkers in treated subjects?~        2. Which biomarkers are most affected by treatment?~        3. Is acupuncture a feasible option to help ameliorate any biomarker effects?~        4. Does RT affect subject symptoms?~        5. Is acupuncture a feasible option to help ameliorate any symptom effects?~   "
163715|NCT01422915|"~     The investigators demonstrated that cholestyramine is an effective binding agent in vitro for~     porphyrins. A few isolated case reports of treatment of individuals with a cutaneous~     porphyria suggest that cholestyramine and colestipol effectively remove porphyrins.~     Hypothesis: orally administered colestipol will effectively reduce sun sensitivity and lower~     erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).~   "
163716|NCT01422902|"~     This study is a multi-site, double-blind, randomized, controlled clinical trial to assess the~     safety and effectiveness of plasticity-based, adaptive, computerized-based cognitive~     remediation treatment versus a computer-based control.~      The investigators proposed that a computerized cognitive remediation program based upon the~     principles of brain plasticity may improve information processing and thus drive clinically~     significant improvements in cognitive and functional performance in individuals with~     schizophrenia.~   "
163717|NCT01422889|"~     The purpose of this study is to compile real-world clinical outcomes data for the ION™~     Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.~   "
163718|NCT01422876|"~     This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination~     (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to~     support approval by regulatory authorities.~   "
163719|NCT01422863|"~     The overall goal of this study is to determine the efficacy of a lifestyle intervention,~     consisting of a weight loss diet and exercise on sleep apnea in older adults. The~     investigators will conduct a 3-month intervention in men and women who are sedentary with~     suspected sleep apnea. The investigators hypothesize that the intervention will lead to~     marked improvements in sleep apnea severity and cardiovascular risk markers.~   "
163720|NCT01422850|"~     This study is a phase I study of a cell based prostate cancer therapy, Autologous Lymphoid~     Effector Cells Specific Against Tumor-cells (ALECSAT). Safety and tolerability of a single~     dose has been shown in 13 prostate cancer patients. In this study 20 prostate cancer patients~     will receive 3 doses of the ALECSAT treatment. In this therapy specific cells from the~     patient's own immune system are isolated, activated and re-administered to the patient to~     boost a specific immune response against the cancer cells. The aim of the study is to show~     safety and tolerability for repeated dosing of this type of therapy. It is the hypothesis~     that the cells administered during the therapy will attack the tumor cells and in this way~     stop or slow down the progression of disease.~   "
163721|NCT01422837|"~     The objective of the VIVITROL Registry is to gather real world data on opioid dependence and~     to provide understanding of the health economics of opioid dependence.~   "
163722|NCT01422824|"~     This prospective observational study will evaluate the safety and efficacy of Mircera~     (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on~     haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving~     once monthly Mircera according to standard of care and local labelling during 12 months of~     treatment.~   "
163723|NCT01422811|"~     1. Background: In recent years an increasing trend in excessive lengths of stay has been~          recorded at the Parma University Hospital, compared with regional mean values. Excessive~          lengths of stay have been demonstrated to constitute not just an economic problem, but~          also a clinical and public health issue. Since the measures taken at our institution so~          far have not proven effective, the investigators carried out a literature review, which~          mostly detected observational studies, restricted to the assessment of the impact of a~          single intervention.~        2. Objectives: This project intends to evaluate the effectiveness of a multifaceted~          strategy aiming to empower clinicians on the issues associated with excessively long and~          avoidable hospital stays, and enable them to identify corrective measures (according to~          the principles of clinical governance).~        3. Study design: cluster-randomized, parallel group, open-label, community trial~        4. Methods: trained personnel will periodically record causes for excessive lengths of stay~          in all participating wards using an ad hoc data collection sheet. In the wards~          randomized to the experimental group, interventions aimed to clinician empowerment -~          provision of reminders and periodical audits - will be implemented.~        5. Expected results: A reduction in the experimental vs. the control arm unnecessary~          lengths of stay is expected, although the introduced measures will also presumably lead~          to improvement in the wards where they are not implemented.~   "
163724|NCT01422798|"~     The aims at investigating how the diagnosis of Tuberculosis in children in a setting of high~     TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of~     the new WHO recommended TB drug dosages.~   "
163725|NCT01422785|"~     There are many different factors that cause acne. So combination treatment using different~     medications that can address these different factors is commonly used to treat acne.~     Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl~     peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of~     the medications when used together.~   "
163726|NCT01422772|"~     The purpose of this study is to evaluate the safety of VM202RY direct injection into the~     cardiac muscles of the coronary artery territory where complete revascularization could not~     be done even through Coronary Artery Bypass Graft.~   "
163727|NCT01422759|"~     Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal~     glands of girls with obesity and androgen excess~   "
163728|NCT01422746|"~     This study will test whether metformin administration can ameliorate androgen (male hormone)~     overproduction in overweight pubertal girls with androgen excess. The investigators~     hypothesize that improvement in insulin sensitivity by 12 weeks of metformin administration~     will improve androgen levels after adrenal stimulation testing with adrenocorticotropic~     hormone (ACTH) or ovarian stimulation testing with recombinant human chorionic gonadotropin~     (rhCG).~   "
163729|NCT01422733|"~     This study will test whether longer-term suppression of adrenal function can ameliorate~     androgen (male hormone) overproduction in overweight early pubertal girls with androgen~     excess. The investigators hypothesize that suppression of nighttime adrenocorticotropin~     hormone (ACTH) production by 12 weeks of evening oral hydrocortisone administration will~     improve androgen levels in girls with adrenal androgen overproduction. Specifically, this~     intervention will improve androgen levels after adrenal stimulation testing with ACTH or~     ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).~   "
163730|NCT01422720|"~     This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate~     as adjunctive therapy for partial seizures in elderly patients.~   "
163731|NCT01422707|"~     Short term hydrocortisone to test whether improves excess androgen production from adrenal~     gland and ovaries~   "
163732|NCT01422694|"~     Background:~      - Spondyloarthritis (SpA) is a group of bone and joint disorders that may cause back and~     joint pain and stiffness. In some cases, SpA can lead to abnormal bone growth affecting the~     joints and spine. Some patients have SpA without ever developing these growths, while others~     develop them after only a few years. Researchers are interested in studying people with SpA~     and their relatives to determine which people are more likely to develop more severe~     conditions.~      Objectives:~      - To identify symptoms and medical tests that can help determine whether a person with SpA is~     at risk for developing more severe forms of the disease.~      Eligibility:~        -  Individuals of any age who have been diagnosed with SpA.~        -  Healthy volunteer relatives (at least 6 years of age) of the individuals with SpA.~      Design:~        -  Participants will be screened with medical records and family medical histories, and~          will be invited to the clinical center for the study.~        -  Participants with SpA will have a physical exam and medical history, including a study~          of joint movement, blood and urine tests, and questionnaires about pain and quality of~          life.~        -  Participants with SpA will have imaging studies, including magnetic resonance imaging~          (MRI). Other samples such as skin tissue and bone marrow may also be collected for~          study.~        -  Healthy volunteers will provide a blood sample and cheek cell samples.~        -  No treatment will be provided, although treatment options will be discussed.~   "
163733|NCT01422681|"~     The minimally invasive extracorporeal carbon dioxide removal may decrease the respiratory~     load during chronic obstructive pulmonary disease (COPD) exacerbation, reducing the need to~     advance the respiratory care toward invasive mechanical ventilation in patients refractory to~     non-invasive ventilatory support (NIV), or decreasing the need of ventilatory support in~     patients already invasively ventilated, thereby accelerating the weaning process.~      The investigators intend to perform a multi-center experimental non randomized single arm~     prospective study to investigate the efficacy of the Decap Smart in reducing the intubation~     rate or the duration of invasive mechanical ventilation in patients with COPD treated either~     with NIV or invasive mechanical ventilation (IMV) for severe respiratory failure and~     hypercapnia. The results of the study will be compared to the data available in the~     literature.~   "
163734|NCT01422668|"~     The aim of this study was to evaluate the composition of Khalas, a very common type of dates~     used in the UAE and to determine the effects of drinking Arabic coffee on the results of GI~     tests in both healthy and diabetic subjects.~   "
163735|NCT01422655|"~     Objective: To assess the accuracy of transcutaneous bilirubin (TcB) measurements in neonates,~     in relation to gestational age (GA), time (postnatal hour) and site (forehead, sternum, knee)~     of measurements.~      Hypothesis: Using (or combining) different sites for TcB determination might improve the~     accuracy of TcB in relation to the time of measurement and the GA of the neonate.~      Methods: The study will include neonates >32 weeks' gestation cared for in the well-baby~     nursery and NICU of the University Hospital of Patras, from September to December 2011. Data~     such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO~     group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight,~     postnatal medications and interventions, type and volume of feeding, and extension of~     jaundice, will be collected.~      TcB measurements will be performed using the BiliCheck bilirubinometer (according to the~     standard protocol) at 3 different sites: forehead, sternum and knee. Total serum bilirubin~     (TSB) values will be obtained using the heel stick technique, and measurements will be~     performed by a direct spectrophotometric device (Unistat bilirubinometer, Richert, Depew,~     NY). The accuracy of the device has been validated previously. TSB measurements will be~     performed within 5 minutes of the TcB measurements.~      At each occasion TcB measurements (3), the corresponding TSB value, the time of measurement~     (postnatal hours), and the actual weight will be noted.~      Statistics: The agreement between TcB and TSB values will be assessed using the Bland-Altman~     % method. The independent and joint effects of GA and time of measurement on bias will be~     evaluated by multivariate regression analysis.~   "
163736|NCT01422642|"~     The purpose of this study is to determine if there are any clinical or ROM differences in~     total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.~   "
163737|NCT01422629|"~     This study is a multicentre, open, uncontrolled trial for the observation of histological~     changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).~      This study will be conducted in France in 20 patients with breast fibroadenoma with~     indication for a surgical resection. The patient will receive an HIFU treatment and 6 months~     after treatment, the need of the surgery is evaluated.~   "
163738|NCT01422616|"~     ENCHANTED is an independent, investigator initiated, international collaborative,~     quasi-factorial randomised controlled trial involving a package of 2 linked comparative~     randomised treatment arms, which aims to address 4 key questions in patients eligible for~     thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg)~     intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent~     benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP)~     lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline~     recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg)~     intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of~     symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering~     to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)?~      The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication~     of the results in May 2016. The BP intensity arm of the study is ongoing.~   "
163739|NCT01422603|"~     This study has been designed to investigate the safety and feasibility of using a~     chemotherapy drug, Clofarabine, to reduce the disease burden before a donor transplant, in~     patients with high risk Acute Myeloid Leukaemia or Myelodysplasia (MDS). In this study~     Clofarabine chemotherapy will be given a few days before a reduced or full intensity donor~     stem cell transplant and without waiting for normal blood counts to recover. It is hoped that~     this approach may improve the outcome for patients with high risk AML and MDS after their~     transplant.~   "
163740|NCT01422590|"~     1. Explore pharmacodynamics~             -  glucose~             -  insulin~             -  C-peptide~             -  glucagon~             -  intact GLP-1~             -  DPP-4 activity~             -  CGMS (continuous glucose monitoring system)~        2. Assess Safety~             -  adverse events~             -  clinical laboratory test~             -  physical examination~   "
163741|NCT01422577|"~     Early detection of colo-rectal adenoma using colonoscopy can prevent occurrence of colon~     cancers. While colonoscopy is a standard technique, it can miss early cancers. To improve the~     detection rate, Narrow Band Imaging (NBI) was introduced in 2006. It has been shown to~     compare favorably with chromo-endoscopy in the sensitivity and specificity in the diagnosis~     of malignant colo-rectal neoplasms. The major drawback of NBI is that images become dark in~     the presence of blood and fecal matters. The bright-NBI is a prototype imaging technology~     that enables endoscopists to obtain better images in suboptimal conditions. The study~     proposes to compare the performance of colonoscopy using either white light or bright NBI in~     subjects undergoing screening colonoscopy in search for colon adenomas.~      Purpose~      To determine that bright -NBI is superior to WLE in detecting colorectal adenomas in average~     risk subjects undergoing screening colonoscopy.~   "
163742|NCT01422564|"~     This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to~     the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a~     primary cementless total hip replacement.~   "
163743|NCT01422551|"~     The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress~     management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial~     adaptation and physiological adaptation in women being treated for stage I-III breast cancer.~   "
163744|NCT01422538|"~     This clinical trial will evaluate clinical outcomes associated with the non-invasive~     Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.~   "
163745|NCT01422525|"~     At present, trabeculectomy is the most common performed and effective surgical method of~     filtration surgery for patients with medically uncontrolled glaucoma.~      The aim of this prospective observational case study is to determine changes of the~     peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence~     tomography in patients with glaucoma after surgical reduction of intraocular pressure.~   "
163746|NCT01422512|"~     This study will evaluate safety and immunogenicity of surface, antigen, inactivated,~     influenza vaccine produced in mammalian cell culture when administered to adult and elderly~     subject.~   "
163747|NCT01422499|"~     The aim of this study is to define a dose recommendation of vorinostat in pediatric oncology,~     to determine pharmacokinetics of vorinostat in children, determine response rates, safety and~     feasibility.~   "
163748|NCT01422486|"~     Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat~     (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell~     (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome~     (MDS).~   "
163749|NCT01422473|"~     The purpose of this study is to examine the advantages and disadvantages of using the EnSeal~     device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques.~      It is hypothesized that the use of the Enseal device will demonstrate an improvement a~     patient's overall experience through less postoperative bleeding and pain, decreased time for~     wound healing, and a faster return to work.~   "
163750|NCT01422460|"~     The investigators will try to find any efficacy of platelet rich plasma injection for the~     treatment of osteoarthritis (OA) in the subtalar joint. Autologous platelet-secreted growth~     factors (GFs) may have therapeutic effects in OA capsular joints via multiple mechanisms. The~     investigators aim is to examine the effect of a platelet-derived preparation rich in growth~     factors(PRGFs) in OA of the subtalar joint, using parameters of pain, function, quality of~     life and safety.~   "
163751|NCT01422447|"~     The purpose of this research is to establish a suitable community-based model for Chinese~     culture,to improve the community recognition of common mental disorders,as well as its~     treatment and control.~   "
163752|NCT01422434|"~     The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once daily~     with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily~     in Japanese subjects with psoriasis vulgaris.~   "
163753|NCT01422421|"~     The purpose of this study is to determine whether intensive blood pressure and low density~     lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in~     Japanese diabetic patients with coronary artery disease and history of acute coronary~     syndrome.~   "
163754|NCT01422408|"~     This phase II trial studies how well giving fluocinonide cream works in treating symptoms of~     vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing~     hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual~     intercourse in patients undergoing hormone therapy.~   "
163755|NCT01422395|"~     Indications for oocyte (egg) vitrification (fast freezing) include the preservation of~     reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or~     surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows~     patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical~     dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation~     could allow women to delay childbearing if they want or need to. Until recently, conventional~     cryopreservation protocols have remained too inefficient for practical application in an~     infertility center. Very little is known about the effects of vitrification on oocytes and~     subsequent embryo development, especially using the sibling model (group of oocytes from the~     same cohort of ovarian follicles within patient). The purpose of this study is to examine the~     effect of oocyte vitrification on fertilization rates, embryo quality and development.~   "
163758|NCT01422356|"~     Studies indicate that men who have sex with men (MSM) have a high prevalence of anogenital~     Human papillomavirus (HPV) infection and increased risk for HPV related anogenital lesions~     including anogenital warts, anal intraepithelial neoplasia (the abnormal proliferation of~     cells) and anal cancer. Currently in Australia, HPV vaccine for men is not covered by~     programs. This study will explore the prevalence of HPV infection and sexual behaviours~     associated with varying prevalence of HPV infection.~      The investigators will survey 200 MSM aged 16-20 years who just started their sexual life.~     The investigators will use a questionnaire to collect information of socio-demographic~     characteristics, lifetime sexual experience, recent sexual experience, the most recent sexual~     contact, sexually transmitted infections (STIs)/HIV history and testing history, HPV~     knowledge and attitude, smoking/alcohol/drug/circumcision. The investigators will also~     collect oral, penile and anal samples as well as blood samples to test for HPV DNA and~     antibody.~      The study will include four visits in the 12-month period. In each visit, participants will~     be asked to fill a questionnaire and provide oral, penile and anal samples as well as blood~     samples.~   "
163759|NCT01422343|"~     Although microparticles have been well-documented as mediators of inflammation and~     coagulation in various cardio-vascular disease events, it is currently not known how~     Percutaneous Transluminal Angioplasty (PTA) for peripheral arterial disease influences~     microparticle numbers, phenotype and distribution pre- and post interventionally and how they~     are related to or affect the incidence of early re-stenosis - or if indeed they may be used~     to predict patients at risk of early re-stenosis.~   "
163760|NCT01422330|"~     The purpose of this study is to learn more about the safety and tolerability of etravirine.~     Etravirine is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has~     shown high activity against wild-type human immunodeficiency virus (HIV-1), and HIV strains~     resistant to other non-nucleotide agents.~   "
163761|NCT01422317|"~     The object of this study was to evaluate the effect of a high-dose ethylester concentrate of~     of n-3 fatty acids administered early after an acute myocardial infarction on subsequent~     cardiac events and serum lipids.The second purpose of this study was to assess the impact of~     high-dose n-3 fatty acids on several markers of coagulation, inflammation, endothelial~     dysfunction and lipid peroxidation. Re-investigation was intended after a prolonged~     wash-out-period.~   "
163762|NCT01422304|"~     This study will assess the effect of reversal of neuromuscular blockade with sugammadex~     compared with reversal according to usual care (neostigmine or spontaneous reversal) on the~     incidence of post-surgical bleeding events and on coagulation parameters in participants~     undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular~     blockage induced by rocuronium or vecuronium.~   "
163763|NCT01422291|"~     This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous~     single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.~   "
163764|NCT01422278|"~     Evaluating the effects in functional status after three weeks of cognitive - and behavioural~     rehabilitation on patients with gait disorder. The patients are followed up as after 1 and 12~     months to study if any improvement is still present. The patients are being recruited from~     neurological units. The intervention is explanation of symptoms, positive reinforcement of~     normal behaviour and absence reinforcement of dysfunctional behaviour. In addition the study~     aims at describing typical gait patterns at patients with gait disorder by using~     biomechanical measurements (EKG).~   "
163765|NCT01422265|"~     This multicenter, observational, prospective study will include approximately 20 US-based~     centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary~     peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months after~     first-line platinum-based chemotherapy (first recurrence). Patients who have completed~     second-line chemotherapy and are currently in observation or undergoing bevacizumab~     maintenance treatment will be eligible to participate in the study.~   "
163766|NCT01422252|"~     The objective of this study is to evaluate the evolution 6 months after a fall occurring at~     home in people over 75 equipped or non-equipped with a precocious detection device. The~     possibility to establish a relation between the alert emitted by the device, the time~     separating the fall from the arrival at hospital and the potential consequences for the~     persons will be analyzed with the greatest accuracy. Besides, the sequences of intervention~     of the different operators will be described with precision. 200 persons living at home in~     the ESSONNE(France)and having fallen at least one time during the previous 3 months will be~     included in the study and two groups of 100 will be constituted randomly after having signed~     a written consent. Of the 2 groups, one will be constituted with persons equipped with a~     precocious fall detection device named Vigi'Fall® , the second being non-equipped. After a~     first visit checking that the inclusion criteria are abide by and the installation of the~     device in the persons designated randomly for being equipped, a second visit will be carried~     out after 10 months in order to know the evolution, i.e. if the persons are still alive,~     living at home or having left for admission in an institution (hospital, nursing home,~     retirement home...). By a detailed comparison between the 2 groups, it will be possible to~     evaluate the potential interest of having been equipped or non-equipped with a precocious~     fall detection device. Hence, a change in practices may lead to a prevision of elderly~     persons likely to benefit of a precocious detection device and to the development of~     prevention in hospital geriatric departments, geriatric care networks, emergency departments~     and local services for the elderly and disabled. Another possible gain of the study is to~     sensitize the medical, paramedical and social teams to the usefulness of precocious detection~     devices in elderly subjects at risk for falls.~   "
163767|NCT01422239|"~     The purpose of this study is to develop and pilot test a smoking cessation counseling that~     focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and~     negative affect, loss of enjoyment).~      Aim 1: To develop the risk-based smoking cessation intervention.~      Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks~     of quitting is feasible to administer and acceptable to adult women who want to quit smoking.~      Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment~     in comparison to standard smoking counseling. It is expected that women who receive~     risk-based counseling will show better quit rates and a longer time to relapse than women who~     receive standard treatment.~   "
163791|NCT01421927|"~     Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a~     controversial topic because of a high risk of relapse and a significant transplant-related~     mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now~     performed after reduced-intensity conditioning regimens. In these conditions, TRM usually~     range from 10 to 20%. However, reducing the intensity of the conditioning invariably~     increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies~     to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and~     evaluated.~   "
163792|NCT01421914|"~     This is a study to calculate the minimum effective volume of bupivacaine 0,5% with~     epinephrine for successful axillary brachial plexus block for hand surgery in 50% of the~     patients (MEV50).~   "
163768|NCT01422226|"~     Over the last several years, more and more women are choosing intrauterine contraception~     (IUDs) to meet their birth control needs. The effectiveness of IUDs is very similar to tubal~     sterilization, with an overall unintended pregnancy rate of less than 1% in the first year,~     and lower failure rates in subsequent years. Intrauterine contraception has many attributes~     besides its effectiveness; it is easily reversible, has a low side-effect profile, and~     provides a long-term solution for contraception (10 years for the copper T380 and 5 years for~     the levonorgestrel IUD). In addition, using an IUD for birth control requires little on-going~     effort by the woman to be effective and offers immediate return to fertility with its~     removal.~      The biggest increase in users is among nulliparous women (women who have not had children),~     due to increased awareness of the safety of modern IUDs in this population, and the many~     benefits of the method. In fact, The copper IUD (Paragard) is now FDA approved for use in~     nulliparous women, and the American College of Obstetricians and Gynecologists supports the~     use of both copper and levonorgestrel IUDs in nulliparous women. The cervix of a nulliparous~     woman has a smaller diameter which can lead to more difficult and uncomfortable IUD~     insertions. Many providers avoid offering IUDs to nulliparas because of fears that the~     procedure will be more difficult, and may require cervical dilation, placement of a~     paracervical nerve block, or placement under ultrasound guidance, none of which are standard~     for parous women. The medication misoprostol is a prostaglandin E1 analog. Because of~     misoprostol's known ability to cause cervical dilation, some family planning providers give~     their nulliparous patients a dose of this drug prior to IUD insertion. Misoprostol is~     commonly used to dilate the cervix for similar procedures as in first trimester abortions,~     hysteroscopy and endometrial biopsies. Its efficacy in cervical priming for IUD insertion is~     unknown, and some concern exists that uterine contractions caused by the drug may lead to~     device expulsion or displacement.~      In this study, the investigators propose to ask nulliparous women who have undergone~     contraceptive counseling and decided to use an IUD for birth control to be randomized to the~     use of misoprostol or placebo prior to their scheduled IUD placement.~   "
163769|NCT01422213|"~     Major Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD~     primarily involves mood disturbances, patients also usually present alterations in cognitive~     function (attention, memory, executive functioning and psychomotor speed). Even though~     antidepressants are suggested in the literature to potentially improve cognitive dysfunction~     in patients with MDD to some degree, there is a lack of adequate and well-controlled studies~     to investigate this effect. This study will evaluate the efficacy, safety and tolerability of~     a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult patients~     with MDD.~   "
163770|NCT01422200|"~     The purpose of the study is to compare the immune response of two different injection methods~     (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among~     patients with neuromuscular conditions who have significant muscle degeneration. This~     research study hypothesizes that the subcutaneous route of vaccine administration, as~     compared to the intramuscular route, may confer at least comparable, or possibly better,~     immunogenicity. At least 30 individuals followed by the CCHMC Neuromuscular Comprehensive~     Care Center will be recruited to participate in this study lasting approximately one to two~     months with two clinic visits and one follow-up telephone call. Immunogenicity will be~     assessed by comparing hemagglutination inhibition (HAI) antibody titers obtained pre- and~     post-vaccination.~   "
163771|NCT01422187|"~     This is a multi-center trial to further extend the assessment of the safety and efficacy of~     taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled~     in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of~     taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months~     or until taliglucerase alfa is commercially available to the subject at the discretion of the~     Sponsor.~   "
163772|NCT01422174|"~     INTRODUCTION: Sudden cardiac death is one of the most important reasons of death at~     industrialized countries. Despite its importance, nowadays Clinical Guidelines are not as~     extended as expected, with respect to indications for primary prevention defibrillator~     implantation, following MADIT II and MUSTT criteria, especially at Latin American countries.~      OBJECTIVES: This Project is designed with the purpose of providing tools to help spreading~     primary prevention by the means of clinical evidence on real risk of death in this group of~     patients.~      REGISTRY DESIGN:~        -  retrospective (at stage 1); prospective (at stage 2)~        -  multi-center (minimum 25-30 centres)~        -  international (Argentina, Brazil, Colombia, Chile, Mexico and Venezuela)~        -  non randomized.~        -  Sample size: at screening about 12.500 patients and 962 patients at treatment stage~      REGISTRY DEVICES: CE marked (Conformité Européenne) single-chamber, dual-chamber or CRT~     (Cardiac Resynchronization Therapy) implantable cardiac defibrillator (ICD).~   "
163773|NCT01422161|"~     The purpose of this study is to determine whether injections of botulinum toxin (commonly~     known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles~     controlling the hand, will lead to improved use of the hand when compared to injections of~     placebo (a substance that looks similar to the study drug but contains no active study~     medication).~   "
163774|NCT01422148|"~     Postoperative atrial fibrillation (POAF) is a common complication after heart surgery.~      Amiodarone is the drug of choice to treat POAF. Inflammation is considered one of underlying~     factor for POAF. Minocycline is an antibiotic with anti-inflammatory properties.~   "
163775|NCT01422135|"~     This is a pharmacokinetics and safety study over 3 weekly applications.~   "
163776|NCT01422122|"~     There is a gap in knowledge regarding the effects of Vitamin D supplementation on periodontal~     status in pregnant wome. The investigators aim to evaluate the potential benefit, if any of~     vitamin D supplementation during pregnancy on periodontal disease and relevant outcomes~     including burden of infections and prematurity rates.~      the investigators hypothesize that~        1. Vitamin D supplementation during pregnancy improves the periodontal health.~        2. There is an association between inflammatory biomarkers and periodontal health of~          pregnant females.~        3. Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates~          and birth weight~   "
163777|NCT01422109|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by~     Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in~     healthy male volunteers.~   "
163778|NCT01422096|"~     This study will test whether short-term suppression of ovarian function can ameliorate~     androgen (male hormone) overproduction in overweight girls with androgen excess. The~     investigators hypothesize that one dose of depot leuprolide agonist administration will~     improve androgen levels in girls with ovarian androgen overproduction. Specifically, this~     intervention will improve androgen levels after ovarian stimulation testing with recombinant~     human chorionic gonadotropin (rhCG).~   "
163872|NCT01420861|"~     The purpose of this study is to assess the effect of GTx-758 on Serum Prostate-specific~     antigen (PSA) levels in men with castrate resistant prostate cancer who are maintained on~     androgen deprivation therapy (Serum PSA response and Serum PSA progression)~   "
163779|NCT01422083|"~     A loss of mobility in the shoulder in direction of internal rotation is associated with~     shoulder tendon pathology. Cause-effect relationship between these two is still not clear. It~     is suspected that this loss of mobility reduces the size of the tunnel in which this shoulder~     tendon is lying, namely the subacromial space. Overhead athletes frequently show glenohumeral~     internal rotation deficit (GIRD) while being healthy and free of shoulder pain. This makes~     this population interesting to investigate. This study wants to look at shoulders of overhead~     athletes with GIRD and measure the size of the subacromial space. After this, the athletes~     will be instructed to perform a home stretching program and at the end the effect of this on~     mobility and the size of the subacromial space will be measured.60 athletes will be recruited~     and randomly allocated to the control group and the stretching group. Before they start~     stretching, subacromial space size will be measured by use of ultrasound. This is a safe and~     non-invasive measuring tool. Mobility will be measured by use of a digital inclinometer. This~     also is safe and non-invasive. Patients will be instructed a stretching exercise, which they~     will be performing at home once a day during 6 weeks. At the end all outcome measures will be~     reassessed.~   "
163780|NCT01422070|"~     The starting point of ELOISE is the significant number of Intensive Care Unit (ICU) survivors~     who die after the transfer to ward. This mortality rate nullifies the sophisticated~     diagnostics and the life-support therapies adopted in the ICU.~      The inadequate care available at the destination ward has been suggested as one of the~     reasons to explain the bad outcome of some ICU survivors, but most hospitals do not have~     enough ICU beds to prolong the ICU stay until the patient has fully recovered. Therefore,~     Inter Mediate Care Units (IMCU) with levels of nursing staff and costs lower than ICU but~     higher than wards have been proposed to facilitate discharges of ICU patients. Unfortunately~     the literature does provide evidence of efficacy of IMCU.~      The primary aim of the study is to assess whether the patients admitted to ICUs with~     availability of IMCU have lower hospital mortality than those admitted to the ICU without~     availability of IMCU.~      Secondary aims are as follows:~        1. To compare Lengths Of ICU and Hospital Stay (LOIS and LOHS, respectively) of patients~          admitted to ICUs with or without availability of IMCU.~        2. To assess the influence of IMCU on the rate of ICU readmissions.~        3. To compare the hospital survival of patients discharged to IMCU and general ward (in~          hospital with or without availability of IMCU) adjusted for severity of illness and~          nursing workload at ICU discharge. This last aim will require a larger sample size (more~          than 10,000), but we hope to collect such a sample.~   "
163781|NCT01422057|"~     The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a~     prognostic marker in type-2 diabetics with ischemic heart disease~   "
163782|NCT01422044|"~     The purpose of this study is to test the prognostic value of autonomic markers in patients~     with aortic stenosis.~   "
163783|NCT01422031|"~     The aim of this study was to find out the utilization rate and pattern of primary health care~     services, and the process and outcomes of primary care consultations of the general~     population in Hong Kong, and whether having a family doctor would make any difference.~      The study objectives were to determine~        1. the rates and pattern of utilization of different primary health care services and~          self-care~        2. Patient self-reported outcomes (global rating on change in health, satisfaction and~          patient enablement) of primary care consultations;~        3. the process of care in consultations including drug and non-drug managements,~          investigations, preventive care and referrals;~        4. the effect of having a regular family doctor on service utilization rate and pattern,~          health promotion practice, and process and outcomes of primary care consultations.~   "
163784|NCT01422018|"~     Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard~     exudates secondary to diabetic retinopathy.~      Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive~     patients showing focal edema with hard exudates secondary to diabetic retinopathy which are~     not eligible for focal laser photocoagulation due to central location (< 500 µm from fovea).~   "
163785|NCT01422005|"~     The purpose of this study is to examine if practicing joint movements using specially~     designed devices can help in the recovery of muscle function in the arm/hand after a stroke.~     Subjects may qualify for participation in this study because they had a stroke and have had~     difficulty using their affected arm/hand ever since.~   "
163786|NCT01421992|"~     The purpose of this study is to determine whether methylphenidate is effective in the~     treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).~   "
163787|NCT01421979|"~     The aim of this study is to examine the safety and the effects of EDs at high doses, either~     alone or in combination with other risk factors such as alcohol intake, physical exercise and~     sleep deprivation, on cardiovascular markers and subjective health.~   "
163788|NCT01421966|"~     Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus.~     These ulcers are reported to be the leading cause of hospitalization among people with~     diabetes.~      The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity~     ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing~     activated homologous white blood cells prepared from donated healthy whole blood. A total of~     280 patients will be randomized to receive either CureXcell® or sham.~   "
163789|NCT01421953|"~     Computed tomography (CT) images, used for radiotherapy planning, are often caught out in lung~     target volumes delineation because of their inability to differentiate between neoplasia,~     inflammation and atelectasia. Positron Emission Tomography (PET) is a new functional imaging~     modality and is currently used in the diagnosis and the staging of lung cancers. The aim of~     this study is to evaluate the impact of 4D 18F-FDG-PET-CT on radiotherapy planning for lung~     cancers.~   "
163790|NCT01421940|"~     Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to~     the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The~     purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical~     co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal~     excision.~   "
163814|NCT01421628|"~     Ageing is related to a decrease in physical fitness, disability and age related symptoms like~     nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity~     and mobility to increase physical fitness and decrease disability and nocturnal cramp in~     older adults.~   "
163793|NCT01421901|"~     The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the~     highest incidence in the second decades . The aetiology of AA is still poor understood: the~     commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix~     barrier and thus wall perforation and/or abscess formation1. However some studies suggest~     that no-complicate and complicate appendicitis are different entities allowing a different~     treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic~     treatment compared to surgery in a population with high probability to suffer of 1st episode~     of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment~     compared to surgery in a population with high probability to suffer of 1st episode of AA.~   "
163794|NCT01421888|"~     Objectives:~        -  To study nutrition and immune system problems in people with urea cycle disorders.~        -  To study how people with urea cycle disorders and healthy volunteers respond to standard~          flu and/or hepatitis A vaccines.~        -  To compare differences in nutrition and immune systems of people with urea cycle~          disorders with that of healthy volunteers.~      Eligibility:~        -  Healthy males and females at least 2 years of age who are able to travel to the National~          Institutes of Health hospital in Bethesda, MD~        -  Males and females at least 2 years of age who have a urea cycle disorder and are able to~          travel to the National Institutes of Health hospital in Bethesda, MD.~      Design:~      For Patients with urea cycle disorder:~        -  Participants will spend 2 to 3 days in the National Institutes of Health hospital for~          the following tests:~        -  A physical exam and review of medical history~        -  Food log for 3 days before the start of the study~        -  Blood tests~        -  24-hour urine collection~        -  Resting metabolism test~        -  DEXA scan imaging study of bones and body fat~        -  Participants who are old enough to do certain tasks by themselves (like dressing and~          eating) can choose to have the following extra tests:~        -  24-hour metabolic room measurements~        -  BodPod(Registered Trademark) study to measure bones and body fat~        -  Participants may choose to have a flu shot and/ or Hepatitis A shot at the end of the~          study and will be monitored to check for possible side effects.~        -  Participants will return within 1 to 3 months for follow-up tests/immunizations.~      For Healthy Volunteers:~        -  Participants will be seen at the outpatient clinics at the National Institutes of Health~          hospital for up to 2 visits for the following:~        -  Review food log completed 3 days before the start of the study~        -  Blood tests~        -  Participants may choose to have a flu shot and/ or Hepatitis A shot at the end of the~          study and will be monitored to check for possible side effects.~        -  Participants will return within 1 to 3 months for follow-up tests/immunizations.~        -  Review of second food log completed 3 days before second outpatient visit~   "
163795|NCT01421875|"~     RATIONALE: Studying blood samples from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers related to chemotherapy resistance and~     outcomes in samples from older patients with acute myeloid leukemia.~   "
163796|NCT01421862|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer who failed~     treatment may help doctors learn more about changes that occur in DNA and identify biomarkers~     related to cancer resistance. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies biomarkers in samples from adult patients with acute~     myeloid leukemia who failed standard-of-care treatment.~   "
163797|NCT01421849|"~     Study hypothesis: that there would be no difference in patient satisfaction among~     institutionalised older people before and after treatment with a mandibular single~     implant-retained overdenture.~      In a preliminary phase, a new denture is made or the old denture is adapted to provide a~     well-fitting denture.~      Eight weeks after insertion of the new denture a single implant is placed in the centre of~     the mandibula. If the level of primary stability is sufficient to enable the implant to~     resist micromovement, the implant is immediately loaded . If not, the implant is loaded after~     6 to 12 weeks. Primary stability is assessed by the final seating torque and by the~     clinician's interpretation and tactile sense of primary stability. Before, during and after~     the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item~     questionnaire and a clinical examination.~   "
163798|NCT01421836|"~     1. Purpose of the study~           -To compare stent patency and complication rate between endoscopic ultrasound (EUS)~          guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided~          stent insertion for malignant biliary obstruction~        2. Subjects of the study~           -Patients who have biliary obstruction owing to malignant tumors~        3. Methods of the study~             -  Prospective randomized controlled study~             -  Patients were enrolled randomly in two groups, EUS guided stent insertion group or~               ERCP guided stent insertion group~             -  Patients will get assigned procedure (EUS guided stent insertion or ERCP guided~               stent insertion)for decompression of malignant biliary obstruction~             -  After the procedure, regular follow up, blood test,and imaging test will be done to~               check sufficient biliary decompression,stent patency and complications.~   "
163799|NCT01421823|"~     The purpose of this study is to assess the effect and safety of alpha agonist ointment on~     fecal incontinence severity in patients with idiopathic fecal incontinence.~   "
163800|NCT01421810|"~     Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body~     hair, irregular menstrual periods, or no menstrual periods excess body weight, and~     infertility. It also results in elevated androgen levels such as testosterone. In women with~     PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown~     whether the ovaries are fully active during early puberty. The purpose of this study is to~     determine how the ovaries contribute to the production of male hormones in the body during~     different stages of puberty, so that it can be better understood why some females have excess~     androgens.~   "
163801|NCT01421797|"~     Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much~     facial and body hair, and weight gain. Women with PCOS also have a hard time becoming~     pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as~     adults. Some girls with high levels of male hormone will develop normal hormone levels as~     they grow up, but most girls continue to have high levels of male hormone as adults. The~     purpose of this study is to understand where the male and female hormones come from in girls~     as they get older. The investigators think the adrenal gland, makes most of the hormones in~     young girls and that the ovary and the adrenal gland make these hormones in older girls. The~     investigators would like to find out whether an overactive adrenal gland makes these hormones~     higher in girls who are overweight, compared to those who are not overweight.~   "
163802|NCT01421784|"~     In this study, the researchers investigate the feasibility of using rapid cine MR imaging to~     provide both offline and online soft-tissue-based image guidance. Such images will provide a~     significantly more complete picture of the spatial and temporal changes in thoracic anatomy.~     This more complete information will lay the groundwork for better radiotherapy planning and~     dose delivery in the presence of respiratory motion.~   "
163873|NCT01420848|"~     Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing~     School students of Beneficence Portuguese Hospital and review the effectiveness of true and~     placebo auriculotherapy.~   "
169283|NCT01349790|"~     NewGam is a newly developed human normal immunoglobulin solution for intravenous~     administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in~     patients with primary immune thrombocytopenia.~   "
163803|NCT01421771|"~     Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although~     studies in the general population have demonstrated a continuous reduction in CV risk with~     each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in~     hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension~     may have decreased mortality compared to those with normal blood pressure (BP). The~     investigators recently reported that among HD patients, those with routine pre-dialysis BP~     values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (<140/90 mm~     Hg) had increased mortality compared to patients with mild to moderate hypertension. However,~     these observational studies included untreated patients in whom low or normal BP may reflect~     significant cardiac disease or other comorbid conditions. In the setting of reduced vascular~     compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or~     cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or~     beneficial. A well-designed randomized control trial (RCT) is needed to answer this important~     question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to~     assess feasibility and inform the design of the former. The investigators propose to conduct~     a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of~     treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.~   "
163804|NCT01421758|"~     This study was designed to determine whether participation in an online social network~     intervention increases perceived social support for physical activity versus a minimal~     education control group by conducting a randomized controlled trial with 140 female~     undergraduate students. The investigators hypothesize that participants in the physical~     activity centered online social network intervention group will have greater increases in~     perceived social support for physical activity compared to minimal web based physical~     activity education controls.~   "
163805|NCT01421745|"~     There are three purposes for this study:~      I. to establish the construct validity (via factor analysis) of the Inventory for Assessing~     the Process of Cultural Competence Among Healthcare Professionals - Student Version~     (IAPCC-SV) II. to determine the responsiveness of the IAPCC-SV III. to investigate~     demographic predictor variables of the IAPCC-SV~      It is hypothesized that:~      I. the variables will load on only one component, with each component being represented by a~     number of strongly loaded variables II. the IAPCC-SV will demonstrate responsiveness,~     evidenced by significantly higher post-module IAPCC-SV scores of the experimental group when~     compared to the control group III. the cultural composite score and race will be significant~     predictors of IAPCC-SV score~   "
163806|NCT01421732|"~     A study of dengue in children presenting to outpatient departments of 5 large hospitals in Ho~     Chi Minh City and Tien Giang province, Viet Nam.~      Different blood tests are compared at the early stages of dengue fever onset in their ability~     to accurately and specifically detect children whose dengue will progress to severe disease.~   "
163807|NCT01421719|"~     The basic nerve deficit of Parkinson's disease (PD) leads to lower urinary tract symptoms of~     frequency, urgency and urge urinary incontinence. Lower urinary tract symptoms tend to occur~     at more advanced stages of PD. In the over-65 year old age group, where 1% of men suffer from~     this disease, they are also prone to development of benign prostatic hyperplasia (BPH) and~     consequent associated lower urinary tract dysfunction. Similarly the over 65-year age group~     develop spontaneous overactive bladder up to a prevalence of 30% of both men and women. The~     urologic disorder is exceedingly devastating in reducing the quality of life in these~     individuals due to the lower urinary tract symptoms and ultimate urinary incontinence in a~     high proportion of patients.~      While attempts at pharmacologic treatment are partially satisfactory many patients are~     intolerant of oral drugs.~      Botulinum-A neurotoxin (BTX-A) has been shown in pilot trials to be quite effective in~     reducing overactive bladder symptoms and is specifically beneficial for a wide-variety of~     neurogenic bladder causes of over activity . The treatment procedure of injecting the~     detrusor muscle of the bladder with BTX-A is quite simple, does not impose significant risks~     to the patient, and can be performed as an office urologic procedure.~      This pilot clinical trial intends to demonstrate the safety and efficacy of low-dose Botox-A~     injections into the bladder to improve urinary symptoms in 20 patients.~   "
163808|NCT01421706|"~     Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy~     subjects~   "
163809|NCT01421693|"~     The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever. Three~     hundred patients at Patan Hospital will be enrolled in the study. Patients will be assigned~     to one of the two treatments by chance and followed for 6 months. The two treatment groups~     will be compared to see which treatment is more likely to make the patient better.~   "
163810|NCT01421680|"~     The objective of this study is to evaluate the effect of a perioperative nutrition strategy~     using oral nutritional supplements (ONS) on postoperative complications and improvement in~     body weight in malnourished patients who underwent gastrectomy.~   "
163811|NCT01421667|"~     This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and~     safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin~     lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab~     vedotin in combination with rituximab in patients with relapsed or refractory diffuse large~     B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression~     and response in DLBCL (Part C).~   "
163812|NCT01421654|"~     The purpose of the study is to evaluate if using the Acclimate feature at the beginning of~     Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least~     as long as they would standard therapy. Additionally, the Acclimate feature will be evaluated~     with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and~     respiratory events.~   "
163813|NCT01421641|"~     The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine~     injection versus topical lidocaine gel on the pain experienced by patients undergoing~     tenaculum application to the cervix during office gynecologic procedures. This study will~     also evaluate how satisfied women are with the method of pain control used.~      The researchers hypothesize that:~        1. There is less pain perceived by patients undergoing placement of a tenaculum on the~          cervix when a lidocaine injection is used compared to a topical lidocaine gel.~        2. Patients are more satisfied with pain control during the overall experience of~          undergoing tenaculum placement on the cervix when a lidocaine injection is used compared~          to a topical lidocaine gel.~   "
163815|NCT01421615|"~     The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial~     vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for the~     patients with durative positive result. It is assumed that the living preparation of~     lactobacillus was beneficial for treatment of BV during pregnancy. The two-courses treatment~     can increase the response rate and improve pregnancy outcomes in the durative BV positive~     patients comparing with one-course one.~   "
163816|NCT01421602|"~     This study will hypothesize that the use of a self fixating lightweight mesh in open inguinal~     repair is feasible in the Philippine setting. It will result in a comparable recurrence rate~     as published for the traditional Lichtenstein approach.~   "
163817|NCT01421589|"~     Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in~     obesity is associated with increased cardiovascular disease risk. However, it is not yet~     known how reduced GH increases cardiovascular disease risk in obesity. The investigators~     hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the~     investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH~     will improve mitochondrial function and that this improvement in mitochondrial function will~     contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The~     investigators propose to study skeletal muscle mitochondria in obese subjects with reduced GH~     secretion using magnetic resonance spectroscopy and muscle biopsies before and after~     treatment with GH.~   "
163818|NCT01421576|"~     A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect~     on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male~     volunteers.~   "
163819|NCT01421563|"~     The purpose of this study is compare the safety and pharmacokinetic characteristics of~     DP-R202 (Sarpogrelate HCl 300mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after~     oral administration in healthy male volunteers.~   "
163820|NCT01421550|"~     The purpose of the present study is to investigate whether or not to perform elective~     surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are~     no other randomized controlled trials in this area. The optimal management in patients with~     umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical~     opinion is that umbilical hernias in patients with ascites should not be corrected because of~     the supposedly high operative risks and high recurrence rates. Conservative treatment,~     however, can have severe complications resulting in emergency repair. Such operations carry a~     higher risk of complications than elective operations, particularly in this group of~     patients. Prospective and retrospective series showed us that elective hernia repair in this~     specific patient group is safe without major complications or high recurrence rates.~      The aim of this study is to asses the optimal timing of correction of umbilical hernia in~     patients with liver cirrhosis and ascites.~   "
163821|NCT01421537|"~     OVERVIEW:~        -  Thromboembolisms represent a serious and feared complication in hospitalized patients.~        -  Several factors make the ICU patient population at increased risk of venous~          thromboembolism.~        -  A high incidence of thromboembolic events is starting to emerge from recent medical~          literature in the burn patient.~        -  Actual guidelines for thromboprophylaxis in burn care patients are based on multiple~          non-burn patient trials.~        -  Burn patient physiology is radically different than that of general ward hospitalized~          patients~        -  Since the actual chemical thromboprophylaxis have not been evaluated in the burn~          patient, it is of interest to assess their efficacy in patients with severe burns.~        -  Hence, the pharmacokinetic characterization of heparins (a well accepted mode of~          thromboprophylaxis) in burn patients could guide future quality of care for this~          subclass of patients.~      Our proposal is based on the conviction that anti-Xa activity of low-molecular-weight~     heparins in the burn patients do not correlate with levels described to prevent~     thromboembolic events in the general hospitalized population.~      The investigators aim to:~        1. To evaluate pharmacokinetics and pharmacodynamics of low-molecular-weight heparins~          (enoxaparin), with anti-Xa levels in severely burned patients receiving~          thromboprophylaxis.~        2. To determine the correlation between antithrombotic activity of heparins and the~          different metabolic phases of the thermally injured patient.~   "
163822|NCT01421524|"~     The main purpose of this first in human study with CC-122 is to assess the safety and action~     of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced~     tumors unresponsive to standard therapies and to determine the appropriate dosing level and~     regimen for later-stage clinical trials.~   "
163823|NCT01421511|"~     This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to~     oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every~     12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment~     with at least 2 IV doses and may receive IV therapy for the entire treatment duration.~      Approximately 100 to 140 sites globally will participate in this study. Patients with an~     ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be~     randomized 1:1 to study treatment.~   "
163824|NCT01421498|"~     The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%)~     compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118~     Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID~     for 12 weeks will also be evaluated.~   "
163836|NCT01421342|"~     The overall purpose is to determine research based 'next-steps' for outpatients with major~     depressive disorder who have not had satisfactory outcomes to standard 'first-step'~     treatments. The primary objective is to compare the acute (up to 12 weeks) treatment~     effectiveness of augmenting an antidepressant with aripiprazole or with bupropion-slow~     release (SR) vs. switching treatment to bupropion-SR monotherapy on symptom remission in~     Veterans with Major Depressive Disorder (MDD) who have not achieved optimal response after an~     adequate trial on antidepressant (a selective serotonin reuptake inhibitor [SSRI] or~     serotonin and norepinephrine reuptake inhibitor [SNRI] or mirtazapine) monotherapy. The~     secondary objectives are to compare the acute (up to 12 weeks) and long term (up to 36 weeks)~     efficacy, safety, effects on functioning, suicidality, quality of life, anxiety and other~     associated symptoms, costs and cost-effectiveness of each of the three treatments.~   "
189132|NCT01088906|"~     This is a study of pemetrexed disodium plus cisplatin as first-line therapy in patients with~     advanced non-squamous cell lung cancer. This is a phase IIA pharmacogenomic trial.~   "
163825|NCT01421485|"~     Youth and young adults in the juvenile justice system have a high prevalence of concurrent~     psychiatric and substance use disorders and are also at high risk for HIV. However, even when~     the disorders and risks are recognized, most programs do not address all of these important~     problems and long-term efficacy for all outcomes simultaneously has yet to be demonstrated~     for these multi-problem youth. Adverse outcomes for youth include partially treated or~     relapsing psychiatric disorders, continued substance abuse, unchanged HIV risk, and further~     legal problems. This project, in collaboration with the Rhode Island Family Court, with whom~     we have existing collaborations, will address these issues by implementing an Integrated~     Treatment Program (ITP) that targets mental health/substance abuse disorders and HIV risk.~     ITP is novel by targeting multiple adolescent problems simultaneously, involving parents to~     augment change, and its delivery within the Family Court. This study will extend our previous~     efficacious interventions among youth with psychiatric disorders to court-involved youth.~     Adolescents and their parents will be enrolled from the Rhode Island Family Court Mental~     Health Clinic where youth aged 13-17 are referred by judges for comprehensive assessment and~     referral for treatment. This randomized controlled trial will test the efficacy, among 200~     sexually active court-involved youth who need outpatient treatment, of the novel, integrated~     treatment (ITP, n=100) as compared to enhanced standard care in community outpatient services~     (ESC, n=100) over an 18-month period (6 months of ITP or ESC and 12 months of follow-up). ITP~     consists of three components: 1) individual cognitive behavioral therapy which includes a~     motivational interviewing component and is modular-based to address concurrent mental health~     and substance abuse issues; 2) family and parent training sessions to address parental~     communication and monitoring to support risk reduction among youth; 3) multifamily group~     workshops to address HIV risk, family communication and peer resistance skills. Youth in both~     conditions (ITP and ESC) will receive similar case management services from the court and~     psychiatric medication management (if needed) from a study psychiatrist. ITP will be compared~     to ESC on reductions in sexual risk behavior, substance use, symptoms of psychiatric~     disorders, and legal offenses.~   "
163826|NCT01421472|"~     To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with~     paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative~     locally advanced operable breast cancer patients.~   "
163827|NCT01421459|"~     The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus~     Lantus in controlling blood sugar levels in combination with two or more oral diabetes~     medications.~   "
163828|NCT01421446|"~     This study is comparing a new computer-based method of administering neuropsychological tests~     to the standard method of verbal and paper/pencil tests administered in person by an~     examiner. The purpose of the research is to determine if the computerized and standard~     testing methods are equivalent.~   "
163829|NCT01421433|"~     Non inferiority, multicentric, double blind study whose the primary objective is to compare~     the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain~     average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain~     evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal~     system.~   "
163830|NCT01421420|"~     The main objective of this research project is to provide a comprehensive clinical database~     of patients with Alzheimer's disease (AD) and other forms of dementia, individuals with mild~     cognitive impairment (MCI), and age-matched normal controls. The study will also attempt to~     identify cognitively normal individuals at genetically defined risk for Alzheimer's disease~     through genetic screening.~      All participants are seen annually. Autopsies to establish diagnoses in patients with~     dementia, patients with mild MCI, and cognitively normal elderly control subjects will also~     be conducted.~   "
163831|NCT01421407|"~     Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD),~     including those who are undergoing long-term haemodialysis treatment. sHPT is characterized~     by persistently elevated levels of parathyroid hormone (PTH) and major disturbances in~     phosphorus and calcium metabolism. When glomerular filtration rate (GFR) falls, the~     phosphorus clearance decreases significantly, leading to phosphorus retention. The resulting~     hyperphosphatemia is thought to be one of the principal causes of secondary~     hyperparathyroidism which is a very early complication of patients with CKD. Its diagnosis~     and treatment is crucial in the management of such patients.The treatment of the sHPT of~     CKD's patient includes dietary phosphate restriction, the use of phosphate binders,~     correction of hypocalcaemia, the use of vitamin D and its derivatives. The calcimimetic agent~     cinacalcet hydrochloride may be also used in combination with vitamin D. While the majority~     of patients can be controlled in this way, medical therapy is not always successful in~     achieving adequate control of secondary hyperparathyroidism. Oral medications (calcimimetics,~     recently developed phosphate binders, and active vitamin D derivatives amount to very high~     monthly costs, and have efficacy limitations as well as side-effects.~      HIFU may become a valuable alternative treatment that help control secondary~     hyperparathyroidism in selected patients presenting with enlarged parathyroid gland(s)~     visible at ultrasonography,.~      The aim of this study is to evaluate the efficacy and safety of HIFU treatment in chronic~     haemodialysis patients with secondary hyperparathyroidism presenting with enlarged~     parathyroid gland(s) which are visible at ultrasonography and for whom medical therapy has~     been unsuccessful.~   "
163832|NCT01421394|"~     This prospective study will assess thoroughly functional deficits and their significance in~     the light of rehabilitation in spinal cord injured patients.~   "
163833|NCT01421381|"~     This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare~     this with the last visit from the SNT-II-003 study.~   "
163834|NCT01421368|"~     The purpose of the study is to examine the effects of two contraceptive methods and the~     menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect~     of the contraceptive methods on markers of mucosal safety.~   "
163835|NCT01421355|"~     Specific Aim: To establish the feasibility of studying the change in endothelial function~     caused by induced moderate hyperbilirubinemia in type 1 diabetes. Atazanavir, a drug that~     inhibits bilirubin conjugation, will be used to induce moderate hyperbilirubinemia.~     Endothelial function will be measured before and after atazanavir therapy. In addition,~     plasma markers of antioxidant capacity and oxidant stress will be measured as~     proof-of-concept that induced moderate hyperbilirubinemia has favorable effects on oxidative~     stress in type 1 diabetes.~   "
163848|NCT01421173|"~     The goal of this clinical research study is to find the highest tolerable dose of vorinostat~     that can be given with gemcitabine, busulfan, and melphalan with a stem cell transplant.~     Researchers also want to learn about the safety and level of effectiveness of this~     combination.~      Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic~     material of cells), which may cause cancer cells to die.~      Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells~     to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not~     allowing these cells to repair the DNA damage caused by busulfan or melphalan.~      Vorinostat is designed to open up the DNA and allow greater access to drugs that bind to DNA,~     such as gemcitabine, busulfan and melphalan.~   "
163837|NCT01421316|"~     Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this~     limited survival it is important to consider quality of life (QOL) when treating these~     patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT~     itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in~     patients with brain metastases. Both fatigue and hair loss were reported to have the largest~     decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung~     cancer. Recent technological improvements in patient positioning and treatment planning will~     allow us to treat the whole brain with reduced margins, allowing better sparing of the scalp.~     In view of the large impact of hair loss on quality of life, the investigators hypothesize to~     see an improved quality of life with scalp sparing techniques.~      Study hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent~     clinically important improvement in QOL.~   "
163838|NCT01421303|"~     Patients with Ankylosing spondylitis more frequently discontinue work. This study measures~     the impact of Enbrel on work participation.~   "
163839|NCT01421290|"~     The hypothesis of this study is to investigate whether surgical intervention is necessary for~     patients who suffer from cartilage lesions of the knee, or whether this surgical intervention~     can be avoided or postponed by using conservative treatment options such as physiotherapy,~     nutrition supplements, intra-articular injections, bracing.~      Forty patients suffering from cartilage lesions in their knee joint will be selected~     preoperatively. All these patients fulfil certain inclusion- and exclusion criteria. They~     will be asked to respond to 3 different questionnaires. These questionnaires include the~     visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome~     Score or KOOS and the International Knee Documentation Committee (IKDC) form to evaluate the~     effect of their cartilage lesion on activities in daily life. Six months later +/- 20~     patients will have had surgery and +/- 20 patients will have had conservative treatment, both~     groups of patients will be asked to respond again to the 3 different questionnaires. The~     outcome of the results will tell us more of the evolution both between groups and in each~     group separately.~   "
163840|NCT01421277|"~     This study will describe the reasons for triptan utilization patterns (continuation and~     discontinuation) in triptan-naïve participants and assess the stability of treatment~     utilization patterns over time according to standard medical guidelines or clinical practice~     standards of the investigating physician.~   "
163841|NCT01421264|"~     In this open-label, pilot study the investigators will be assessing gabapentin's effects on~     insomnia and other concussion-related symptoms in patients with a recent concussion~     experiencing insomnia.~   "
163842|NCT01421251|"~     Many people worldwide received the monovalent adjuvanted H1N1 vaccine. However, very little~     is known about the safety of the vaccine, particularly beyond the first few weeks after~     vaccination. This study will combine data from a well-established immunization registry in~     Manitoba with data from hospitalization and physician records, to examine the safety of the~     vaccine in the six month period post-vaccination. Studies on vaccine safety are important as~     the public's perception of the safety of a vaccine has a major role in its uptake.~   "
163843|NCT01421238|"~     The purpose of this study is to study how people make decisions regarding delivery room~     management for infants born extremely premature when survival and long term outcomes are~     uncertain. The hypothesis is that the way in which information is presented will impact~     decisions.~      There have been many advances in neonatal care in recent decades. However, the investigators~     do not know if these children will grow up to be healthy or if they will have problems with~     mental retardation, behavior or physical handicaps. In these circumstances, where the medical~     profession cannot predict what sort of life a child will have, parents have a choice of~     having intensive care started or of allowing the baby to die naturally. The age most often~     cited by physicians at which this care is optional and under parental discretion is 23 weeks~     gestation.~      The purpose of this study was to ask people, recruited through the world wide web, what they~     would want for the doctor to do in the case of a hypothetical 23 week premature delivery in~     order to evaluate the decision process and the presence of autonomous choice. This study had~     two parts. The first part, presented outcome information in 2 different ways -either as~     survival and lack of severe disability or as mortality and presence of severe disability. The~     results of the first part have been published (Message Framing and Perinatal Decisions,~     Pediatrics, 2008). The second part, investigated whether the way in which the way in which~     delivery room management options were presented- either as agreeing with a course of action~     or opting out- impacted resuscitation decisions. This part was administered as a separate~     survey to a different sample of participants at a later date. The remainder of the~     questionnaires asked demographic and opinion questions as a means to assess variables that~     may influence how people respond to the information they receive.~   "
163844|NCT01421225|"~     The investigators are conducting this study to find out whether a new device can control~     blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have~     high blood sugar levels because they do not make enough insulin. The standard treatment is to~     give insulin either by shots or using an insulin pump. A new device, called closed-loop~     insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a~     computer. The CGM will send the sugar levels to a computer which automatically figures out~     how much insulin to give and then gives that amount of insulin through the insulin pump. It~     will give the child insulin to bring sugar levels down if they are high, and will give less~     insulin if the child's blood sugar is getting lower. Earlier research using closed-loop~     insulin therapy has shown the ability for it to improve diabetes care in adults and older~     children, but there has been no research of closed-loop insulin therapy in young children.~     This study will compare children's current insulin therapy with the closed-loop system. The~     knowledge that the investigators gain from this research will help us to figure out whether~     closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes~     care.~   "
163845|NCT01421212|"~     The purpose of this study is to find the best monthly dose schedule for the new Hepatitis~     Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent~     Lamivudine after liver transplantation. Boca HBVIg will be given along with Lamivudine to~     prevent hepatitis B reinfection following liver transplantation in patients with end stage~     liver failure due to hepatitis B infection.~   "
163846|NCT01421199|"~     The study has three objectives:~        1. To determine if the device can detect if middle ear fluid is present in children who are~          scheduled for tube placement (myringotomy)~        2. If fluid is present to characterize the fluid as thick or thin~        3. Evaluate the safety of the device~   "
163847|NCT01421186|"~     This is an open-label, multicentre, dose escalation study to characterize the safety and~     preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects~     with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with~     relapsed/refractory multiple myeloma in combination with standard therapy.~   "
163854|NCT01421095|"~     Young adult cancer survivors constitute an under served population to whom fertility~     potential is particularly important. For female young adult patients, cancer treatment such~     as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in~     risks of infertility and premature menopause related to ovarian failure. Reproductive issues~     are a major concern for young cancer survivors, but one that is understudied. Young cancer~     survivors have few tools to measure post-treatment ovarian reserve, or the quantity and~     quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential~     would not only be an important research tool, but also directly impact clinical management.~     The purpose of this study is to test if basal and provocative ovarian reserve testing can~     predict return of menses in female young adult cancer survivors, to compare basal and~     provocative ovarian reserve testing results between female young adult cancer survivors and~     healthy controls, and to compare basal and provocative ovarian reserve testing results~     between female young adult cancer survivors on and off of combined estrogen and progesterone~     hormone products.~      Participants will be asked to keep track of their periods over three months. If a participant~     is taking birth control pills, patches, or vaginal ring, they will asked to come off the~     birth control for 3 months. Participants will also be asked to undergo ovarian reserve~     testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.~   "
163855|NCT01421082|"~     The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality~     of life, exercise capacity, and static lung volumes, in patients with emphysema. The~     mechanism of action for these effects is believed to be related to the restoration of elastic~     recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is~     to evaluate several physiologic parameters which should provide measures directly related to~     the mechanism of action by which the coils produce these outcomes.~   "
163856|NCT01421069|"~     This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3~     subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis~     related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96~     weeks of participation in study 0881A1-3338 (B1801014). The study contains an active~     treatment period, withdrawal/re-treatment period and a observational period (non-treatment).~   "
163857|NCT01421056|"~     The purpose of this study is to evaluate the safety and tolerability of ascending oral doses~     of CHF 5074 after prolonged administration to patients with mild cognitive impairment.~   "
163858|NCT01421043|"~     This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg~     is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.~   "
163859|NCT01421030|"~     This study compares clinical, self- reported and cost outcomes in children and adolescents~     treated with pulmonary valve implantation, percutaneous versus open surgical technique. Since~     cardiac surgery in children and adolescents affect the whole family, the experience of the~     patients and their closest relatives are recorded and analysed separately. Cost may be an~     important factor in the choice of technology (1). Hence, the present study also aims to~     compare savings in costs, percutaneous versus open technique, related to the individual,~     their family and society.~      1.2 Research questions~        1. Percutaneous pulmonary valve implantation or open heart surgery; what are the patients'~          and their closest relatives narrative experiences~        2. Is there a difference in patient and their closest relatives reported outcomes, measured~          as health related quality of life, in patients with congenital pulmonary disease before~          the event, 1, 3, 6 and 12 months after percutaneous intervention versus open heart~          surgery approach?~        3. What is the relationship between patient reported outcomes and clinical outcomes before,~          1, 3, 6 and 12 months after the treatment?~        4. Are there savings in costs related to the individual and their family and society~          between the two techniques?~   "
163860|NCT01421017|"~     This study is to find an optimal dose of Imiquimod (IMQ) in the first part (Phase I) and test~     the effectiveness of the combination treatment of IMQ, cyclophosphamide (CTX), and~     radiotherapy (RT) in patients with skin metastases from breast cancer in the second part~     (Phase II). Currently this trial is in its Phase II part.~   "
163861|NCT01421004|"~     This is a multi-center, open-label, two way crossover study designed to test the~     bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients~     with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate~     that those 2 formulations are considered to be the same for all intents and purposes by~     making sure they are acting on the body with the same strength and are absorbed in similar~     amounts by the body. During the bioequivalence phase, patients will take orally at a daily~     dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days~     on/2days off dosing schedule, after which time, patients will switch to the alternate~     formulation for one additional week. After the bioequivalence phase, all patients may~     continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until~     disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation~     from the study treatment for any other reason.~   "
163862|NCT01420991|"~     Aneurysmal subarachnoid hemorrhage (aSAH) is the most deadly kind of stroke. Each year,~     40,000 Americans have SAH. Case-fatality approaches 60% and more than half of those who die~     do so before reaching the hospital. Most commonly, SAH results from rupture of an~     intracranial aneurysm. Screening high-risk individuals could identify those at greatest risk~     and decrease the devastating effect of SAH. Aortic Aneurysm also constitutes a major public~     health problem with high lethality. Current estimates are that ruptured aortic aneurysm kills~     13,000 Americans each year. Screening efforts have effectively lowered mortality from aortic~     aneurysm rupture but a high proportion of those who die did not have a diagnosis of aortic~     aneurysm prior to rupture.~      The relationship between intracranial and aortic aneurysm has long been recognized, but~     poorly quantified. Recent genome-wide association studies (GWAS) provide a molecular~     biological evidence for a shared pathophysiology. The chromosome 9p21 locus confers increased~     risk for both intracranial aneurysms and aortic aneurysms. These GWAS data, along with~     linkage data for other susceptibility loci, indicate that individuals and families harboring~     one type of aneurysm may be at especially increased risk of the other.~      The rationale for this project is that opportunistic screening for abdominal aortic aneurysms~     (AAA) may be warranted in patients who present with aneurysmal subarachnoid hemorrhage. This~     study is meant to see if the yield of screening in this population is too low to justify its~     routine use. The investigators plan to systematically screen for AAA in all cases of aSAH~     presenting to MCH for treatment. If no individual out of 81 consecutively screened cases of~     aSAH has evidence of AAA, then the investigators can have strong confidence that there is a~     less than 5% chance of finding an AAA in the patient population.~   "
165741|NCT01396317|"~     This is a fifteen-month open label, Phase IIa clinical trial is being conducted to assess the~     tolerability, safety and efficacy of a medication called Tocilizumab (Actemra®) in patients~     with polymyalgia rheumatica (PMR).~   "
163863|NCT01420978|"~     When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often~     develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the~     brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to~     drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a~     patient does not tolerate this and a permanent surgery needs to be done to internalize a~     shunt.~      Though this is done commonly and routinely throughout the world, there are no good studies to~     address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a~     level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which will~     allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve~     perfusion at the level of the microcirculation in the brain, and result in improved~     neurologic outcomes.~   "
163864|NCT01420965|"~     Background:~      - Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a~     person with prostate cancer and treats them in the laboratory. Then it returns the cells to~     the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the~     drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide~     will also be given, either before or after the cells are collected at the start of the~     treatment.~      Objectives:~      - To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate~     cancer.~      Eligibility:~      - Men at least 18 years of age who have advanced prostate cancer.~      Design:~        -  Participants will be screened with a medical history, physical exam, blood and urine~          tests, and imaging studies.~        -  This study has two parts, with different participants in each part. All participants~          will be monitored with frequent blood tests and imaging studies.~        -  Part I:~        -  Participants will provide cells for the Sipuleucel-T treatment three times. The first~          time will be 3 days before the chemotherapy. The second time will be 10 days after~          chemotherapy. The third time will be 24 days after chemotherapy.~        -  Participants will have one dose of cyclophosphamide the day before the first dose of~          Sipuleucel-T.~        -  Participants will have Sipuleucel-T about 3 days after each cell donation.~        -  Part II:~        -  Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or~          given with both cyclophosphamide and CT-011.~        -  Participants will provide cells for the Sipuleucel-T treatment three times, as in Part~          I.~        -  Participants will have Sipuleucel-T about 3 days after each cell donation, and will~          receive treatment with the other drugs as directed by the study doctors.~   "
163865|NCT01420952|"~     Background:~      - (11C)mGlu1 is a new drug that helps to show where a protein, mGluR1, is found in the brain.~     The drug contains a small amount of radioactivity that can be detected by imaging studies~     like positron emission tomography (PET) scans. By looking at the mGluR1 receptors,~     researchers hope to better understand how they are involved in general health, brain~     disorders, and addiction.~      Objectives:~        -  To test how (11C)mGlu1 is distributed in the brain and body.~        -  To measure how mGluR1 receptors display (11C)mGlu1 during imaging studies.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and urine~          tests. This study requires four visits to the NIH Clinical Center.~        -  Participants will have an initial evaluation, a magnetic resonance imaging (MRI) scan, a~          PET scan, and a final blood sample after the PET scan, all at different visits.~        -  The MRI and PET scans will focus on the brain. Participants will receive (11C)mGlu1, and~          have scans to see how it shows up in the brain.~        -  Some participants will have whole body imaging studies to see how (11C)mGlu1 shows up in~          the body.~   "
163866|NCT01420939|"~     Background:~      - A person who has a traumatic brain injury (TBI) -- also called concussion -- can have~     serious and long-lasting effects. Doctors who treat TBI need more information about how the~     brain changes over time in people with TBI and how well a person recovers from it. To make~     existing TBI treatments more effective and develop new ones, researchers want to look more~     closely at how TBI affects people both physically and psychologically.~      Objectives:~      - To collect medical information from people with recent traumatic brain injury and compare~     this information to that of healthy volunteers and of persons who have had injuries to other~     parts of their bodies besides their heads (such as broken bones, orthopedic injuries, after~     surgery).~      Eligibility:~      3 groups of people between the ages of 18 and 70 years will be asked to take part.~        -  Persons who have had a traumatic brain injury (or concussion ) within the past 30 days,~          OR~        -  Persons who are healthy and have never had a traumatic brain injury, OR~        -  Persons who have had an injury within the past 30 days to a part of their body other~          than the head (such as a broken bone, orthopedic injury, surgery)~      Design:~        -  This study requires two outpatient visits each lasting 1 1/2 days. The 2 visits will be~          about 30 days apart. Persons with TBI and non-TBI injuries must have their first visit~          within 30 days of their injury.~        -  Screening: Participants will be screened with a medical history, physical examination,~          blood tests and electrocradiogram (ECG a routine heart test).~        -  The research will involve:~             1. Giving blood samples (no more than 75 ml each visit).~             2. Having tests of memory, attention, concentration, and thinking (neuropsychological~               testing).~             3. Having imaging studies of the head including magnetic resonance imaging (MRI) and~               positron emission tomography (PET) scans.~        -  Persons with TBI will have the same tests at Visit 1 and 2. Healthy controls and persons~          with non-TBI injuries will have the same tests at Visit 1 as listed above. But, at Visit~          2, they will not have brain MRIs or PETs.~        -  No treatments will be provided as part of this research protocol.~   "
163867|NCT01420926|"~     This randomized phase II trial studies how well giving decitabine with or without bortezomib~     works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy,~     such as decitabine, work in different ways to stop the growth of cancer cells, either by~     killing the cells,by stopping them from dividing, or by stopping them from spreading.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. It is not yet known whether decitabine works better when given with or without~     bortezomib in treating acute myeloid leukemia.~   "
163868|NCT01420913|"~     The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A,~     YHD1119 B, YHD1119 C and Lyrica capsule.~      YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.~      Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T~     max,ss, t 1/2~   "
163869|NCT01420900|"~     The investigators want to examine if specific acetabular liner designs can be a contributing~     factor to audible squeaking associated with CoC bearings. The aim of the present study is to~     compare two different designed and well documented acetabular component systems with~     reference to squeaking and other noises from the hip.~   "
163870|NCT01420887|"~     This pilot study is designed to determine if the rehabilitative benefits of continuous~     passive motion (CPM) will help preserve/restore the joint function and significantly improve~     the rate of recovery of patients after the surgical release of elbow contractures better than~     standard physiotherapy and static splinting.~   "
163871|NCT01420874|"~     The purpose of this research study is for the participant to give their own T cells (a type~     of blood cell in the body that can fight infections and possibly cancer) to them after they~     have been removed, grown in a lab, and then coated with an experimental drug.~      This study will determine the highest dose of EGFR2Bi coated T cells that can be given~     without causing severe side effects. Initially a group of 3 participants will receive the~     same dose of study drug. If no serious side effects occur, the next group of participants~     will receive a slightly higher dose of study agent. The following groups of participants will~     receive higher doses of the study drug until a dose is reached where there are unacceptable~     side effects and maximum tolerated dose is found, or the planned highest dose level is~     reached with no side effects.~   "
165798|NCT01395563|"~     The purpose of this study is to determine whether prednisone, methotrexate, and~     cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both~     ears due to autoimmune inner ear disease (AIED).~   "
163876|NCT01420809|"~     This post-marketing surveillance study was designed to collect and assess the information on~     proper use of fondaparinux injection, such as the safety and efficacy under actual use~     conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of~     developing venous thromboembolism.~      (ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)~   "
163877|NCT01420796|"~     Parkinson's disease (PD) is a chronic, degenerative disease described by motors and~     non-motors symptoms. Changes in swallowing and respiratory dynamics increase risk of tracheal~     aspiration largely responsible for increased morbidity and mortality in this population.~     Thus, interdisciplinary rehabilitation strategies can reduce the complications of dysphagia,~     with consequent improvement of the prognosis of individuals with PD. Objective: To determine~     the impact of combined oral motor exercises and breathing exercises on swallowing disorders~     in individuals with PD. Method: Clinical trial, randomized and blinded for the examinator.~     For all subjects will be given the stage of PD and applied quality of life questionnaire. The~     swallowing complaints will be investigated through structured questionnaire and functional~     aspects of swallowing with videofluoroscopy. The Manovacuometry Spirometry will determine~     measures of respiratory function. The assessment of vocal and speech disorders will be done~     with perceptive, acoustic, aerodynamic and electroglottographic measures as well as analysis~     of intelligibility. Three groups of intervention will be defined: one of them doing oral~     motor exercises for swallowing, one doing breathing exercises and another must do this two~     interventions combined. Effect of intervention will be assessed through measures of~     swallowing, breathing, voice and speech. The groups will be compared, according to the~     principle of intention to treat by appropriate statistical tests, according to the~     distribution of the dependent variables.~   "
163878|NCT01420783|"~     Primary Objective:~        -  Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg~          SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per~          European LeukemiaNet criteria) for :~             -  Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months~               in patients with polycythemia vera, and~             -  Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients~               with essential thrombocythemia.~        -  PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate~          the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or~          intolerant to hydroxyurea (per European LeukemiaNet criteria) for:~             -  Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and~               continuing through Day 1 of Cycle 6 visit in patients with PV, and~             -  Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit~               and continuing through Day 1 of Cycle 6 visit in patients with ET.~      Secondary Objectives:~        -  To evaluate the safety of SAR302503.~        -  To evaluate the efficacy of SAR302503 in patients with PV who are resistant or~          intolerant to hydroxyurea for inducing absence of phlebotomy eligibility.~        -  To evaluate the efficacy of SAR302503 in patients with ET who are resistant or~          intolerant to hydroxyurea for reduction of platelet counts.~        -  To evaluate the efficacy of SAR302503 in inducing complete and partial responses~          beginning at Day 1 of Cycle 6 visit through Cycle 8.~        -  To evaluate splenic response as measured by spleen volume using MRI or CT.~        -  To evaluate the pharmacokinetics of SAR302503 after single and repeat doses.~        -  To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele~          burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition.~        -  To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated~          symptoms, as well as overall impact on quality of life.~        -  To measure generic health-related quality of life and utility value using the EuroQol~          Group (EQ-5DTM) questionnaire.~   "
163879|NCT01420770|"~     Primary Objective:~      - To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 for~     the reduction of spleen volume as determined by magnetic resonance imaging (MRI).~      Secondary Objectives:~        -  To evaluate the safety of SAR302503.~        -  To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat doses.~        -  To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele~          burden in those patients with JAK2V617F mutation, changes in substrate phosphorylation~          in the JAK-STAT signal transduction pathway, and the expression of cytokines.~        -  To measure improvement in baseline Myeloproliferative Neoplasm (MPN) associated~          symptoms, as well as overall impact in quality of life (QOL), through serial~          administration of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF).~        -  To measure generic health-related quality of life (HRQL) and utility values using the~          EQ-5D questionnaire.~   "
163880|NCT01420757|"~     Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up~     to 54%. If a mesh is used, the defect can be closed tension-free. Using this method,~     recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is~     a relatively new technique in which the mesh is positioned intraperitoneally. Research has~     shown that this procedure is technical feasible and may have benefits for the patients.~      The ongoing debate about the merits of endoscopic versus open incisional hernia repair~     prompts the need for a level 1 randomized controlled trial.~   "
163881|NCT01420744|"~     The purpose of this study is to determine whether the adjunctive therapy to standard~     antibiotic treatment of BT086 is safe and effective of decreasing the days patients require~     endotracheal ventilation due to Severe Community-Acquired Pneumonia (sCAP).~   "
163882|NCT01420731|"~     Back pain is a common hormonal disorder in men that may affect the phases of male sexual~     function. The investigators investigated sexual function in male patients with back pain.~      A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the~     as control group were evaluated with a detailed medical and sexual history, including a~     international erectile function index (IEFI) questionnaire and the Beck Depression Inventory.~     Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione,~     17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These~     variables were compared statistically between the 2 groups.~   "
163883|NCT01420718|"~     The purpose of this study is to compare the human pulp response to partial pulpotomy using~     White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.~   "
163884|NCT01420705|"~     The prevalence of asthma and allergic diseases is increasing worldwide. Infections and~     vaccinations in childhood may have an impact on the subsequent development of asthma and~     allergy. In Guinea-Bissau, the investigators previously found that Bacille Calmette-Guérin~     (BCG) vaccine was associated with reduction in atopy. Since then the investigators have~     conducted a randomised trial of BCG vaccine given at birth to low birth-weight infants. The~     present study aims to follow up children enrolled in the BCG randomised trial to assess for~     asthma and allergy later in childhood. Based on previous observations, the investigators~     expect children allocated to receive BCG at birth will have a reduction in allergy profile~     when compared to children who did not receive BCG at birth.~   "
163924|NCT01420172|"~     This will be a retrospective study and analysis of subjects who have undergone a~     hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC~     at any time between 01Jan2000 and 30Jun2011.~      This study will determine factors influencing pulmonary disease and associated treatment~     strategies.~   "
165799|NCT01395550|"~     AstraZeneca was interested in knowing how Cardiologists and Physicians treat patients who~     have suffered a cardiovascular event.~   "
163885|NCT01420692|"~     The main purpose of this study is to analyze the effects of the addition of sulfonylurea~     (gliclazide MR) or ,alternatively, basal insulin (insulin detemir) to life-style modification~     and metformin treatment as a second step treatment in type 2 diabetes mellitus on endothelial~     cell functions. The second goal is to identify the effects of these treatment alternatives on~     body-mass index, the changes in body fat mass, insulin resistance and on the insulin~     secretion capacity of beta cells. The third aim of this study is to determine the success~     rates of these treatment alternatives on glycemic control at 6 months follow-up.~   "
163886|NCT01420679|"~     The purpose of this study is to see if pralatrexate extends response and survival following~     CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone)~     and if pralatrexate improves response in patients with partial response following CHOP-based~     chemotherapy. Patients will either receive pralatrexate or be under observation. All patients~     will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their~     disease and health.~   "
163887|NCT01420666|"~     The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are~     greater than acetaminophen, ibuprofen or placebo in patients who have painful osteoarthritis~     of the hip or knee.~   "
163888|NCT01420653|"~     The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are~     greater than acetaminophen, ibuprofen or placebo.~   "
163889|NCT01420640|"~     The investigators will conduct a large randomized controlled trial comparing the~     effectiveness of Tai Chi mind-body exercise and standard-of-care aerobic exercise for~     fibromyalgia. In addition, the investigators will determine the optimal frequency and~     duration of a Tai Chi intervention for short and long-term effectiveness.~   "
163890|NCT01420627|"~     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of~     EZN-2279 in patients with ADA-deficient combined immunodeficiency currently being treated~     with Adagen.~   "
163891|NCT01420614|"~     Prospective, randomized, multi-center trial comparing the safety and efficacy in the~     prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach~     for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing~     primary angioplasty~   "
163892|NCT01420601|"~     To confirm the safety of the long-term use of TORISEL 25 mg for Intravenous Drip Infusion~     particularly for the onset of interstitial lung disease from Weeks 25 to 96 after the start~     of administration.~   "
163893|NCT01420588|"~     The investigators study the feasibility of a novel method in oncology based on breath~     analysis with a nanosensors array for identifying gastric diseases. Alveolar exhaled breath~     samples collected from volunteers referred for upper endoscopy or surgery are analyzed using~     a custom-designed array of chemical nanosensors based on organically functionalized gold~     nanoparticles and carbon nanotubes. Predictive models are built employing discriminant factor~     analysis (DFA) pattern recognition method. Classification accuracy, sensitivity and~     specificity are determined using leave-one-out cross-validation or an independent blind test~     set. The chemical composition of the breath samples is studied using gas chromatography~     coupled with mass spectrometry (GC-MS).~      A pilot study is conducted first (enlistment of 160 subjects at the Department of Oncology,~     The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of~     Anhui Medical University, Hefei, Anhui, China.)~      The pilot study is followed by a large-scale clinical trial to confirm the preliminary~     results of the Chinese pilot study (enlistment of 800 subjects at the Digestive Diseases~     Centre GASTRO, Riga East University Hospital, 6 Linezera iela, LV1006 Riga, Latvia). 25% of~     the samples are used as independent blind test set. The samples are blinded by the medical~     team and are not disclosed until prediction of blind sample identity is complete.~   "
163894|NCT01420575|"~     We hypothesize that the use of a visual decision aid tool to educate patients regarding~     potential harm with respect to weight gain with olanzapine versus perphenazine can lead to~     better shared decision making by patients, increase rates of antipsychotic switches and~     promote weight loss in overweight patients with schizophrenia/schizoaffective disorder.~      Our specific aims are the following:~        1. To investigate the effects of a visual decision aid, versus care as usual, on patients'~          perceived difficulties in medical decision making regarding switching antipsychotics in~          overweight veterans with schizophrenia or schizoaffective disorder.~        2. To investigate the effects of a visual decision aid and a shared decision making model~          on rate of medication switches (from olanzapine to perphenazine) in overweight veterans~          with schizophrenia or schizoaffective disorder.~        3. To investigate the effects of a visual decision making aid and shared decision making~          model on BMI in overweight veterans who switch from olanzapine to perphenazine therapy.~   "
163895|NCT01420562|"~     The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough~     levels of posaconazole reached in patients with different stages of mucositis, due to~     chemotherapy and total body irradiation.~   "
163896|NCT01420549|"~     The purpose of this study is to determine the non-inferiority between two different FDC,~     measuring LDL-Cholesterol levels, in high risk patients by NCEP-ATP III, with primary~     hypercholesterolemia or mixed dyslipidemia.~   "
163897|NCT01420536|"~     The objective of this study is to compare the canine guidance (CG) and bilateral balanced~     occlusion (BBO) on denture satisfaction and kinesiographic parameters of complete denture~     wearers, by means of a cross-over trial. Edentulous patients will receive new maxillary and~     mandibular complete dentures and, after the intraoral adjustments and adaptation period, will~     randomly receive a sequence of occlusal schemes: BBO followed by CG, or CG followed by BBO.~   "
163898|NCT01420523|"~     Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with~     virological success, presenting with clinical lipohypertrophy.~   "
163899|NCT01420510|"~     We hypothesise that the use of Adelmidrol (Saginil in vaginal cannulas) can reduce the~     incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.~   "
163900|NCT01420497|"~     Several studies have shown that in diabetic patients, the glycemic profile was disturbed~     after intra-articular injection of corticosteroids. Little is known about the impact of~     epidural injection in such patients. The goal of this study was double, at first comparing~     the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate~     methylprednisolone either intra-articular or epidural, secondly to compare the amount of~     systemic diffusion of the drug the after both procedures.~   "
163901|NCT01420484|"~     The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with~     pronounced variation of arterial pressure will be assessed under analgosedation.~      Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP~     undergoing elective transfemoral aortic valve implantation procedures. Systolic, diastolic,~     and mean invasive arterial pressures (IAP) will be compared to those obtained by CNAP. Data~     will be analysed in different periods of arterial pressure for agreement of the two methods~     and for determination of precision (i.e. measurement error) and accuracy (i.e. systematic~     error). Additionally, we will compare both methods regarding the amplitude and time of very~     fast changes in arterial pressure during intervals of functional cardiac arrests (rapid~     pacing).~   "
163902|NCT01420471|"~     All adult patients undergoing sinus surgery for chronic rhinosinusitis (CRS) that satisfy the~     inclusion/exclusion criteria will be included in the study.~      All patients enrolled in this study will have spacers (impregnated with saline or~     Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as~     their own controls. Nostril's will be randomized to either the experimental treatment~     (Triamcinolone-impregnated spacer) or the control treatment (Saline-impregnated spacer).~     These spacers will be removed after 6-days post-op.~      Participants will undergo the standard post-operative endoscopic sinus surgery follow-up~     appointments plus one additional research visit (not standard of care). This includes~     follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the~     post-operative period. During these appointments, the surgeon will assess the post-operative~     mucosal appearance (Philpott-Javer Sinus Rating System). SNOT-22 surveys will be~     administered, as per standard protocol, at each post-op follow up visit.~      Sinus tissue biopsies will be taken from both meati on 28-day and 3-month post-op follow-up~     appointments for analysis.~      Our objective is to determine if triamcinolone soaked Merocel middle meatus spacers (MMS) in~     a perforated glove finger improves patient outcomes, wound healing and reduces inflammation~     compared to a standard saline-soaked merocel sponge within a perforated glove finger in CRS~     patients receiving FESS.~      Our hypothesis is that triamcinolone-medicated Merocel MMS are not inferior to standard~     saline-soaked spacers, when both are enclosed in a perforated surgical glove finger.~   "
163903|NCT01420458|"~     This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will~     be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled~     concurrently.~   "
163904|NCT01420445|"~     The study will conduct with 4 comparative groups orally treated with YHD001 dose level~     1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo~     for 7 days.~      The treatments will be assigned randomly to patients (n=116) with acute or chronic~     bronchitis.~   "
163905|NCT01420432|"~     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells~     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for~     the therapy of Ankylosing spondylitis (AS)~   "
163906|NCT01420419|"~     The purpose of this study is to evaluate the effectiveness of lanolin for the treatment of~     painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has~     an effect on breastfeeding outcomes such as duration and exclusivity.~   "
163907|NCT01420406|"~     The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and~     beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol~     concentrations in lactating Bangladeshi women.~   "
163908|NCT01420393|"~     Atrial fibrillation and heart failure are two common heart conditions that are associated~     with an increase in death and suffering. When both of these two conditions occur in a patient~     the patient's prognosis is poor. These patients have poor life quality and are frequently~     admitted to the hospital. The treatment of atrial fibrillation in heart failure patients is~     extremely challenging. Two options for managing the atrial fibrillation are permitting the~     atrial fibrillation to continue but controlling the heart rate, or to convert the atrial~     fibrillation rhythm back to normal and try to maintain the heart in sinus rhythm. Until now,~     the method to keep the patient in normal sinus rhythm is with antiarrhythmic drugs. Studies~     using antiarrhythmic drugs to control the rhythm failed to show any survival benefit when~     compared with permitting the patient to be in atrial fibrillation. In the last few years, new~     development in techniques and technologies now enable catheter ablation (cauterization of~     tissue in the heart with a catheter) to be a successful treatment in abolishing atrial~     fibrillation and that this approach is better than antiarrhythmic drug to control the rhythm.~     However, there has not been any long-term study to determine whether catheter ablation to~     abolish atrial fibrillation in heart failure patients would reduce mortality or admissions~     for heart failure.~      This study is to compare the effect of catheter ablation-based atrial fibrillation rhythm~     control to rate control in patients with heart failure and high burden atrial fibrillation on~     the composite endpoint of all-cause mortality and hospitalization for heart failure defined~     as an admission to a health care facility for > 24 hours. The investigators will also be~     assessing the cost-effectiveness of this treatment strategy and the life quality for these~     patients. This study may have a dramatic impact on the way the investigators manage these~     patients with atrial fibrillation and heart failure and may improve the outlook and well~     being of these patients.~   "
163909|NCT01420367|"~     Hypothesis: A single dose of prophylactic antibiotics is as effective as a three dose regime~     in preventing post-operative complications in paediatric patients with simple appendicitis.~      This project will compare patients 16 years and under with simple appendicitis (appendicitis~     that is not perforated or gangrenous). Patients will be randomly divided into two groups;~        -  Group one will receive a single pre-operative dose of antibiotics (metronidazole~          12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two 'doses' of normal saline~          (placebo) eight and sixteen hours after the initial dose, respectively.~        -  Group two will receive one pre-operative dose of antibiotics (metronidazole 12.5mg/kg up~          to 500mg and cefazolin 25mg/kg up to 1g) and two post-operative doses, eight and sixteen~          hours after the first dose, respectively.~      Group allocation will be concealed from the patient and their guardian, the treating surgical~     team and outcome assessors (triple blinded). A process to rapidly reveal group allocation if~     required will be in place.~      The aim of the study is to determine if a single dose of antibiotics is as effective as three~     doses in preventing post-operative infection. This will be assessed by comparing:~        -  Duration of hospital stay from operation until discharge, based on a standardised~          discharge criteria.~        -  Development of wound infection or requirement of antibiotics in the six weeks~          post-operation~        -  Need for re-admission.~      Information will be collected prospectively from each patient's hospital notes and from a~     follow-up phone call six weeks after the operation.~   "
163910|NCT01420354|"~     This study will sought to determine if limited urine collections can provide similar or more~     informative data than standard 24-hour urine collections used to evaluate kidney stone~     formers.~   "
163949|NCT01419847|"~     Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of~     onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior~     cost and safety profile compared to systemic therapy.~   "
163911|NCT01420341|"~     This is a randomised, open-labelled, controlled trial to compare the efficacy and~     effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of~     melioidosis. The study population includes 800 patients with culture-confirmed melioidosis~     whom 12 weeks of oral eradication therapy have been completed with or without intravenous~     intensive antibiotics. Patients will be randomised to either stop the eradication treatment~     or continue current oral treatment for 8 more weeks. The study aim to optimise the regimen~     used to treat melioidosis for better compliance and reducing unnecessary use of antibiotics.~   "
163912|NCT01420328|"~     This study focuses on the use of Vytorin to study inflammatory markers in subjects with~     normal cholesterol.~   "
163913|NCT01420315|"~     Recent studies indicate that there is a relationship between cognitive decline and vitamin D~     deficiency. Up to now, no study has investigated the prevalence of vitamin d deficiency in~     patient with Alzheimer's disease. Our aim is to investigate the prevalence of vitamin D~     deficiency and analysis the associated characteristics in patients with Alzheimer's disease.~   "
163914|NCT01420302|"~     The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed~     protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients~   "
163915|NCT01420289|"~     To evaluate the effects of HPIPC for the treatment of symptoms of PAD~   "
163916|NCT01420276|"~     Back paın is a common hormonal disorder in women that may affect the phases of female sexual~     function (FSD). We investigated sexual function in patients with back paın A total of 54~     women with back paın and 27 age matched voluntary healthy women who served as the as control~     group were evaluated with a detailed medical and sexual history, including a female sexual~     function index (FSFI) questionnaire and the Beck Depression Inventory. Serum prolactin,~     dehydroepiandrosterone sulfate, free testosterone, androstenedione,~     17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These~     variables were compared statistically between the 2 groups.~   "
163917|NCT01420263|"~     The purpose of this study is to determine whether re-feeding of gastric residuals reduces the~     time needed to establish full enteral feedings in premature infants. Infants with gestational~     ages 23-28 weeks at birth will be randomized within one week to receive either gastric~     residuals or fresh formula or breastmilk whenever significant residuals during feeding~     advancement require clinical assessment for continuing feedings. Primary outcome measure is~     time to establish full enteral feedings (120cc/kg/day).~   "
163918|NCT01420250|"~     This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with~     concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation~     therapy that uses computer-generated images to show the size and shape of the tumor. Thin~     beams of radiation of different intensities are aimed at the tumor from many angles.) and~     androgen deprivation therapy (Treatment to suppress or block the production or action of male~     hormones) in patients with locally advanced prostate cancer.~      It is hoped that by adding Cabazitaxel to the standard IMRT, greater local disease control~     can be achieved and eventually the cure rate can be increased. After this study, the~     maximally tolerated dose of Cabazitaxel that could be used in combination with radiation can~     be found.~      Men with locally advanced high risk prostate cancer represent a group of patients for whom~     cure is potentially achievable utilizing a multimodality approach. More aggressive treatment~     upfront with chemotherapy and ADT may improve the long term disease control. We hypothesize~     that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel~     approach will improve disease control and eventually improve survival for locally advanced~     prostate cancer patients.~   "
163919|NCT01420237|"~     The purpose of this study is to evaluate the success rate of cementless primary hip~     replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip~     systems in the literature, through absence of femoral head dislocation at 10 years~     postoperative.~   "
163920|NCT01420224|"~     The study hypothesis is that commercial air travel causes an increase in the blood pressure~     in the lungs (pulmonary artery pressure) that can be clinically relevant. Portable~     echocardiography (heart ultrasound) now offers a non-invasive means of studying this~     in-flight.~   "
163921|NCT01420211|"~     The objective of the study is to assess the hepatic uptake of Primovist® after intravenous~     administration of 25 µmol/kg body weight in 56 healthy volunteers and in 60 patients with a~     liver disease in dependence on the OATP1B1- and OATP1B3-genotype.~   "
163922|NCT01420198|"~     An increasing proportion of Sweden's population comprises non-European immigrants, who~     constitute a high risk-population for T2D. Numbering almost 9,000 individuals, Iraqi citizens~     represent the largest immigrant group in Malmoe and are identified as a risk group for Type 2~     Diabetes (T2D) in whom genetic and lifestyle factors probably play significant roles in the~     development of T2D.~      Several studies have shown that adoption of an active lifestyle by at-risk individuals~     dramatically reduces the risk of T2D. However, there are currently no established methods for~     providing support to high-risk individuals from different cultural and social backgrounds to~     help them adopt beneficial lasting lifestyle changes. Instead of just waiting for Iraqi~     high-risk individuals to develop T2D, this project will implement and assess lifestyle~     intervention programs aimed at reducing the risk of developing T2D and tailored to~     individuals with a different social and cultural background.~      The study thus seeks to optimize preventive action in health care and aims to facilitate the~     adoption of permanent changes in lifestyle in high-risk patients, taking account of cultural~     and social barriers.~      Since T2D is associated with a sedentary lifestyle and develops earlier in men than women and~     an average 10 years earlier in immigrants from the Middle East than in native Swedes, it is~     crucial to study pathogenic mechanisms triggering T2D development in relation to sex,~     lifestyle and ethnic background. The results will provide the basis for deciding how health~     care providers can actively work to prevent T2D and other lifestyle-associated diseases in~     this high-risk population that has not been studied before.~   "
163923|NCT01420185|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer. It may also help~     doctors predict whether cancer will come back after treatment.~      PURPOSE: This research trial is studying genes that may predict local recurrence in samples~     from patients with breast cancer. treated on NSABP-B-28~   "
163925|NCT01420159|"~     This study investigates the treatment of acute pain, an unpleasant feeling caused by an~     injury. The overall purpose of the study is to gain more information that the pain relief~     medicine Penthrox(Methoxyflurane) administered using the Penthrox Inhaler(a distinctive~     green, whistle like object that you breathe through) is safe and works at relieving pain in~     patients aged 12 years and older who are admitted to a hospital Emergency Department with a~     minor injury (known as trauma).~   "
163926|NCT01420146|"~     Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled~     trastuzumab.~   "
163927|NCT01420133|"~     Few recommendations concerning the diet and dosage to be administered to patients treated~     with corticosteroids are established.~      It therefore seems important to study prospectively the indication of a diet low in salt and~     sugar in patients undergoing corticosteroid therapy, to record side effects observed and to~     measure their frequency.~   "
163928|NCT01420120|"~     This is a prospective multicenter registry to evaluate safety and performance of the REMEDY,~     biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral~     arteries. Patients will be followed for a period of 1 year.~   "
163929|NCT01420107|"~     A video of the delivery room management will be taken using standardized conditions. The~     video will be evaluated either locally by those directly involved in the delivery room care~     of this specific infant or anonymously at the main study center. Using a standardized~     evaluation form a set of predefined interventions is rated regarding at what time they took~     place and at what time they should have taken place. The difference in time for all~     interventions is summed up to a score. This score should allow to assess the delivery room~     management in comparison to the desired standard as well as between hospitals. The evaluation~     forms of all centers will be analyzed at the main study center to define correlations between~     certain delivery room interventions and short term outcome.~      Aim of the study is to~        -  gather data on how delivery room care is currently done,~        -  come closer to an agreement between different NICUs towards what should be done in the~          delivery room under what circumstances in which way,~        -  find those interventions with potential influence on short term outcome. Those aspects~          of management that are different between centers and show correlation with short term~          outcome will be the focus of future prospective intervention trials in order to find the~          best way how to take care of preterm infants in the delivery room.~      Hypothesis:~      In preterm infants <32;0 weeks of gestational age a correlation exists between specific~     delivery room interventions and short term outcome.~   "
163930|NCT01420094|"~     To compare the safety and efficacy (onset, duration of relief and overall efficacy) of a~     single dose of a fast release formulation of aspirin 1000 mg compared to acetaminophen 1000~     mg and placebo for relief of pain following extraction of impacted third molars.~   "
163931|NCT01420081|"~     This study will investigate the individual safety and efficacy of two dual PI3K/mTOR~     inhibitors in patients with recurrent endometrial cancer.~   "
163932|NCT01420068|"~     52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and~     development in pediatric hypertensive patients previously treated with aliskiren in studies~     SPP100A2365 and SPP100A2365E1~   "
163933|NCT01420055|"~     This is a prospective, open-label, multi-center phase IV study to assess response to~     fingolimod initiation according to coping profile in adult patients with highly active~     relapsing remitting multiple sclerosis in France.~   "
163934|NCT01420042|"~     The purpose of this study is to obtain evidence of safety and determine the pharmacokinetics~     (PK) of NNZ-2566 in healthy volunteers, when administered orally.~   "
163935|NCT01420029|"~     In this observational pilot project, the investigators plan to document duration and sources~     of exposure to plasticizers in infants born at birth weights less than 1500 grams. The~     investigators will examine the association between exposure to plasticizers and outcomes such~     as performance on a neurological screening tool, extrauterine growth, and thyroid function.~   "
163936|NCT01420016|"~     The objective of this project is to develop and implement sophisticated point-of-care~     Electronic Health Record (EHR)-based clinical decision support that (a) identifies and (b)~     prioritizes all available evidence-based treatment options to reduce a given patient's~     cardiovascular risk (CVR). After developing the EHR-based decision support intervention, the~     investigators will test its impact on CVR, the components of CVR, in a group randomized trial~     that includes 18 primary care clinics, 60 primary care physicians, and 18,000 adults with~     moderate or high CVR. This approach, if successful, will (a) improve chronic disease outcomes~     and reduce CVR for about 35% of the U.S. adult population, (b) maximize the clinical return~     on the massive investments that are increasingly being made in sophisticated outpatient EHR~     systems, and (c) provide a model for how to use EHR technology support to deliver~     personalized medicine in primary care settings~   "
163937|NCT01420003|"~     The purpose of this study is to characterize the time course of B cell activation after~     allergen challenge, and more specifically measure the M1 prime related biomarkers.~   "
163938|NCT01419990|"~     The purpose of the study is to evaluate the safety and tolerability of multiple ascending~     oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.~      During the course of the study, the amount of GLPG0634 present in the blood~     (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related~     parameters in the blood (pharmacodynamics) will be characterized.~   "
163939|NCT01419977|"~     Sickle cell disease (SCD) is one of the most common inherited diseases worldwide and exhibits~     highest frequency in people of African descent. Patients with SCD currently have few~     treatment options, with hydroxyurea being the only medication approved to reduce the~     frequency of vaso-occlusive crisis (VOC) and prevent other SCD complications such as acute~     chest syndrome. Once patients develop VOC, hospitalizations aim to alleviate pain; no~     specific therapy is currently available to otherwise affect the course of the VOC. However,~     there has been increasing interest in the role of coagulation in the pathogenesis of SCD. The~     investigators hypothesize that low dose anticoagulant therapy, such as prophylactic dose~     low-molecular-weight heparin (LMWH), could be a novel way to ameliorate the vaso-occlusive~     process and thereby hasten the resolution of pain.~   "
163940|NCT01419964|"~     This is a multicenter clinical trial, phase III, randomized, placebo-controlled, parallel~     group, enroll 94 patients, to assess the efficacy of ACH24 in the repigmentation of~     achromatic areas in patients with vitiligo.~   "
163941|NCT01419951|"~     The objective of this project is to pilot test a behavioral intervention that includes a home~     visit component compared to a clinic only and standard of care for the treatment of obesity~     in preschool age children. The results of this study will inform the design of a larger~     randomized control trial.~      H1: The clinic + home intervention will result in a significantly greater decrease in BMIz~     compared to the in clinic only intervention or pediatric standard of care at 6 months~     post-treatment.~   "
163942|NCT01419938|"~     Delayed sleep phase syndrome (DSPS) is the most common of the circadian rhythm sleep~     disorders (CRSD). A person with DSPS have sufficient sleep quality, but their circadian clock~     is delayed compared to the normal 24-h period. They fall asleep around 03.00-04.00 at night~     and sleeps until 02.00-03.00 in the afternoon. This syndrome is most frequent among young~     people between 16-25 years, which conveys that school attendance and education are affected,~     and also often results in severe social consequences. DSPS is sometimes associated with~     depression and personality disorders and may aggravate psychiatric symptoms.~      This syndrome is highly underdiagnosed and there are no detailed guidelines how to treat it.~     The treatment usually consists of light therapy, chronotherapy or melatonin. There is a lack~     of guidelines how often, with which wavelength, and how long the treatment of DSPS patients~     shall go on. Previous studies shows that light therapy often is effective. The effect gets~     even better if melatonin is administered concurrently. However, the frequency of relapse is~     high.~      Thus, DSPS is a prevalent syndrome in young adults with severe consequences on normal daytime~     functioning. There are almost no treatment options available in health care settings. There~     is a clear need for further studies on this topic. The main purpose of the present study is~     to evaluate the clinical effects of short and long-term treatment by using light therapy and~     cognitive behaviour therapy (CBT). CBT is recommended at mild to moderate depression and~     anxiety. It also has some evidence in treating insomnia. Patients with DSPS often have al of~     these symptoms and therefore the investigators would like to investigate if CBT can enhance~     the effect of light therapy.~      Firstly, the investigators want to evaluate the short-term effects of light therapy with and~     without CBT. Secondly, the investigators want to evaluate if the patients who get CBT~     maintain a normal sleep rhythm and prevent relapse of DSPS compared to just light therapy~     for two weeks.~      The investigators also want to evaluate how this patient-group differs when it comes to~     behavioral factors compared to a matched reference group.~   "
163943|NCT01419925|"~     Multimeric-001 (M-001) has been recently developed, containing conserved, common linear~     influenza epitopes that activate both cellular and humoral arms of the immune system against~     a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an~     attractive candidate for priming immune responses to seasonal influenza vaccine in the~     elderly population. The current clinical study was designed to assess M-001's standalone and~     priming action in subjects over 65 years old.~      This is a second Phase II study comprising 120 participants. Eligible subjects were~     randomized to receive to receive either two sequential non-adjuvanted or a single~     non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment),~     or one placebo (saline) injection, before receiving the TIV.~   "
163944|NCT01419912|"~     Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats,~     inositols might have beneficial effects on controlling complication among diabetic~     nephropathy patients(DN).Most studies in this regard have been examined the effect of soy~     consumption on cardiorenal risk factors among patients with DN and there are few data about~     relationship of soy milk consumption and health effect in patients with DN . Therefore, we~     evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation,~     oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients.~     This was a cross-over randomized clinical trial which was conducted in Isfahan among diabetic~     nephropathy patients. Patients were randomly assigned to consume a diet containing cow's milk~     or a diet in which only one glass of soy milk was substituted; each one for 4 weeks.~   "
163945|NCT01419899|"~     The purpose of this study is to determine if a brief intervention delivered to emergency~     department patients increases the uptake of rapid HIV and hepatitis C testing in comparison~     to no brief intervention.~   "
163946|NCT01419886|"~     Swallowing disorders (dysphagia) are common in adult patients. There is emerging evidence~     that dysphagia itself can cause adverse medical outcomes. There is a three-fold increased~     risk for pneumonia in these patients versus similar patients without dysphagia. Patients with~     dysphagia also suffer poor nutrition and dehydration. Patients can become so malnourished~     that it slows their recovery. Dysphagia can cause choking when food or liquid enters the~     lungs. Over time, this will cause pneumonia and even death. More acutely, patients fear that~     their choking will cause them to suffocate and die. Over time, patients are embarrassed to be~     seen choking and thus feel forced to dine alone. These patients report feelings of isolation~     and depression. To date, there are no practical methods to assess these adverse outcomes of~     swallowing difficulties in patients. This research will be the first to address this gap.~     Specifically, as part of previous research (PhD dissertation by RM, the PI) a new measure of~     medical outcomes of dysphagia was developed, titled the Medical Outcomes of Dysphagia (MOD)~     scale. The MOD consists of 3 subscales that each measure lung, nutrition-hydration or~     psychological consequences in patients with swallowing difficulties. Unlike more expensive~     and complex tests, the MOD has been designed for both in- and outpatients. This research will~     validate each MOD subscale to ensure retention of only items that are reliable and valid for~     use with patients who have dysphagia due to any disease etiology. The final MOD subscales~     will be the first to allow clinicians to track medical complications in their patients and to~     ensure that treatment is effective. Globally, the MOD subscales will direct limited health~     care resources to the most effective treatments for swallowing disorders.~   "
163947|NCT01419873|"~     Very low birthweight neonates commonly develop high blood sugar levels. There is an~     association between high blood sugar levels and poorer short term outcomes but it is not~     known whether the high sugar level itself actually causes the problems.~      There are a range of ways to manage high sugar levels but there are no consensus guidelines~     to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies~     looking at insulin infusions have often used fixed protocols to guide the amount of insulin~     to be given and are often complicated by hypoglycaemia.~      This study investigated whether using a model-based approach to individualise insulin~     administration to neonates with high sugar levels would provide a safe and effective~     management option for controlling blood sugar levels and avoid the complication of low blood~     sugar levels.~   "
163948|NCT01419860|"~     The aim of the study is to describe utility of dynamic fluorescence videoangiography of~     indocyanine green (ICG) in gastrointestinal surgery, for evaluation of microcirculation in~     colon wall and anastomosis before and after surgical resection; and if this technique can~     guide the surgeon to peroperative decision making considering recreate a new anastomosis or~     stoma for preventing anastomotic failure or stomia necrosis.~   "
189146|NCT01088724|"~     Fludarabine may be of benefit to prevent rejection of grafted solid organs in children during~     chemo-immunotherapy treatment for post transplant lymphoproliferative diseases (PTLDs).~   "
163950|NCT01419834|"~     The purpose of this study is to find out if humanized 3F8 (Hu3F8) is safe for treating~     neuroblastoma and other cancers. A phase 1 study means the investigators are trying to find~     out what side effects happen when higher and higher doses of a drug are used.~      The investigators want to find out what effects, good and/or bad, Hu3F8 has on cancer. The~     amount of Hu3F8 that patients gets will depend on when they start treatment on this study.~     The investigators also want to find out more about how Hu3F8 works and how effective it is in~     attacking the disease. Hu3F8 is an experimental drug, which means it has not yet been~     approved by the FDA for the treatment of this disease.~   "
163951|NCT01419821|"~     Abstract Background: Vitamin D affects a wide variety of functions in the body including~     regulation of calcium, phosphorus, and bone metabolism. Israeli studies have documented a~     high prevalence of Vitamin D deficiency in Israeli infants in general, which was more severe~     in infants from Ultra-Orthodox Jewish families. Modest dress requirements in this population~     drastically reduce sun exposure, known to encourage production of Vitamin D. Countless~     research has analyzed preterm as well as term neonates born to mothers with vitamin D~     deficiency, with regard to weight, height, and bone mineral density at birth. However, there~     is a paucity of information about healthy infants' vitamin D levels and its' correlation to~     these parameters during the first few years of life. Objectives: The purpose of the proposed~     study is to measure and correlate levels of 25(OH)D and bone mineral density towards the end~     of the first year of life with growth rates and bone mineral density in the same children at~     the ages of 2, 3 and 5 years. Patients and Methods: The study will be performed in the~     Ultra-Orthodox Jewish community of Beitar Illit. 25(OH)D levels will be taken between 9-12~     months of age (when routine blood tests are normally drawn for these infants) and bone~     mineral density will be measured using Quantitative Ultrasound. Infants will be divided into~     2 groups: those with those with normal 25(OH)D levels (>15ng/ml), and those with 25(OH)D~     deficiency (<15ng/ml). Group 1- normal levels will receive no intervention. Infants with~     25(OH)D below 15ng/ml will be randomly assigned into one of two groups; Group 2-those~     receiving continued vitamin D supplementation of 800 international units(IU) (4gtt/d) for one~     year, or Group 3- those receiving the placebo. Height, weight, and head circumference growth~     curves will be recorded every two months until 2 years of age. Quantitative ultrasound,~     growth charts and blood tests including 25(OH)D, serum calcium and phosphate levels,~     Parathyroid hormone (PTH), and alkaline phosphatase, taken at approximately 9-12 months will~     be repeated at 2 years of age. At that time children from Group 1 (no supplementation) will~     be divided into three: Group 1a- normal 25(OH)D levels will continue with no intervention,~     Group 1b <15ng/ml will begin receiving vitamin D 4gtt/d, Group 1c <15ng/ml will receive a~     placebo until age three. Groups 2 and 3 will continue their previous treatment until age~     three. All aforementioned tests will be repeated at age 3, when treatment will stop, and the~     same tests will be repeated at age 5.~   "
163952|NCT01419808|"~     The purpose of this study is to investigate whether treatment of scaphoid non-unions with a~     vascularized bone grafts improves patient reported pain and disability compared to treatment~     with a non-vascularized bone graft. Secondary objectives are to examine if there is any~     difference in the overall rate and time to union, range of motion, grip strength, or~     complication rates between the two groups.~      In addition, this is the first prospective randomized study to directly compare the two~     techniques. This is also the first study to use standardized methods of assessing union~     (based on computerized tomography), standardized methods of collecting objective patient~     data, and utilizing validated patient questionnaires to assess pain and disability.~   "
163953|NCT01419795|"~     This phase II trial studies how well giving lenalidomide with or without rituximab works in~     treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small~     lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL).~     Biological therapies, such as lenalidomide, may stimulate the immune system in different ways~     and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block~     cancer growth in different ways. Some block the ability of cancer to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them. Giving~     lenalidomide together with or without rituximab may kill more cancer cells.~   "
163954|NCT01419782|"~     The aim of this study is to investigate effects of femur exposed to unilateral vibration on~     the rest muscle electrical activity of contralateral hip adductors and contralateral soleus~     H-reflex in young adult men.~      This study hypothesize that femur exposed to unilateral vibration may affect the rest muscle~     electrical activity of contralateral hip adductors. Vibration can effectively enhance muscle~     strength and power. Previous studies have shown that vibration increases muscle~     electromyographic (EMG) activity. It has been showed that bone has an effect on the increase~     in muscle EMG activity caused by vibration in healthy young adults in a study. In this study,~     it was reported that vibrations-induced increases in muscle electrical activity of flexor~     carpi radialis (FCR) was related to ultradistal radius bone mineral content (BMC) and the FCR~     H-reflex was suppressed or depressed during vibration. This findings were reported to support~     the assumption that the bone exposed to cyclic mechanical loading may neuronally regulate~     muscle activity.~   "
163955|NCT01419769|"~     The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this~     study is being conducted under an Investigational Device Exemption (IDE) granted by the US~     Food and Drug Administration (FDA).~      The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study.~     Up to 10 sites in the United States, European Community and/or Japan will enroll a total of~     24 patients. A majority of the patients will be enrolled in the United States.~      Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst~     resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month~     post-stent removal.~   "
163956|NCT01419756|"~     Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with~     Tetralogy of Fallot following repair; a comparison study to cMRI.~      The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System to~     calculate right ventricular volumes in patients with Tetralogy of Fallot following surgical~     repair.~      Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical~     sites.~      The analyses will be the same for EDV and ESV. For either right ventricular volume, the~     primary effectiveness measure is the % difference between VMS and cMRI results, i.e.~     (VMS-cMRI)*100%/average of VMS and cMRI results. There will be two null hypotheses for the~     primary analysis:~      H0+: true mean % difference > 10% and H0-: true mean % difference < -10%~      The observed mean % difference will be presented with 95% confidence intervals. The VMS right~     ventricular volume estimates will be regarded as equivalent to cMRI estimates if both H0+ and~     H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV. Since H0+~     and H0- cannot both be true, the total type I error rate for each measure is 0.025 and the~     overall type I error rate for both EDV and ESV is 0.05.~   "
164006|NCT01419093|"~     The project is a two-arm randomized clinical trial to pilot the feasibility of a~     communication training intervention for primary care clinicians, linked to a community~     program referral, on use of the 5As to promote physical activity in underserved patients.~   "
189747|NCT01080846|"~     This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line~     treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.~   "
163957|NCT01419743|"~     Historically, vitamin D has been considered to play a role solely in bone and calcium~     metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse~     health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose~     metabolism. In the obstetrics literature, vitamin D deficiency has been linked to~     preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data~     from retrospective chart reviews have demonstrated a possible role of vitamin D in~     implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization.~     Patients found to be deficient in vitamin D were found to have significantly lower clinical~     pregnancy rates when compared to patients who were replete in vitamin D levels. Currently,~     there are no prospective clinical trials investigating the effects of vitamin D~     supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The~     investigators hypothesize that the vitamin D supplementation in patients found to be either~     deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility~     patients undergoing in-vitro fertilization.~   "
163958|NCT01419730|"~     This research will examine the effectiveness of vitamin D or placebo (the placebo is a tablet~     that looks like Vitamin D study drug, but has no Vitamin D study drug in it), with and~     without physical activity (walking and progressive resistance exercise), in treating bone~     loss in women who have undergone treatment for breast cancer. The investigators would also~     like to find out if the physical activity program improves cardiovascular fitness, energy~     expenditure, muscular strength, muscle mass, and balance. One hundred five (105) subjects are~     expected to take part in this study. The investigators don't know if bone loss in breast~     cancer survivors should be treated differently than bone loss in other women.~   "
163959|NCT01419717|"~     This trial will facilitate access of denosumab for subjects with advanced cancer who have~     participated in a denosumab phase 3 study until denosumab is approved and available for sale,~     or until another mechanism is identified to provide denosumab to ongoing subjects.~   "
163960|NCT01419704|"~     The goal of this research study is to establish chimerism and avoid graft-versus-host disease~     in patients with hemoglobinopathies.~   "
163961|NCT01419691|"~     The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat~     patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or~     prolymphocytic lymphoma (PLL).~   "
163962|NCT01419678|"~     This is a single center, observational study of posaconazole PK sampling in lung transplant~     recipients. The patients enrolled will have up to 6 (3ml) pk samples (a total of 18 ml) and~     one 10ml blood sample for a total collection of 28ml of blood obtained over the entire study.~     In addition, the investigators will collect medical record information and any excess BAL~     samples available during the study (tests done as part of the patient's clinical care and the~     samples would have been discarded once diagnosis was made).~   "
163963|NCT01419665|"~     The purpose of this study is to demonstrate comparability of the ORR in patients with~     previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive~     MabThera-treatment.~   "
163964|NCT01419652|"~     There are 24 million people with diabetes mellitus (DM) in the United States. Over one-third~     of patients presenting for coronary angiography have known DM, and an additional 20% of~     patients without known DM present with hyperglycemia on the day of coronary angiography.~     Hyperglycemia in the setting of urgent and elective percutaneous coronary intervention (PCI)~     is associated with a 40% relative increase in long-term mortality regardless of diabetic~     status. Mechanisms linking periprocedural hyperglycemia to adverse outcomes are poorly~     understood and the effects of treatment are unknown. This is a pilot study aimed at~     determining the effectiveness, feasibility and safety of continuing long-acting hypoglycemic~     medications on the morning of coronary angiography. Since hyperglycemia may cause increased~     platelet reactivity, a secondary aim is to evaluate a possible mechanism of benefit of~     periprocedural glycemic control on platelet activity. Patients with DM on hypoglycemic~     medications undergoing coronary angiography will be randomized to either continue or hold~     their clinically-prescribed long-acting hypoglycemic medications on the day of procedure.~     Patients with and without DM will be randomized to either routine care or additional glycemic~     control with the Yale insulin infusion protocol for 6 hours post-PCI. The primary endpoint of~     this study will be mean blood glucose level at the time of arterial access in the hold versus~     continue groups. Secondary endpoints will be mean blood glucose level at 6 hours post-PCI in~     the Yale versus routine care groups and number of hypoglycemic events in the glycemic control~     versus no glycemic control groups. The exploratory analysis assessing the effect of glycemic~     control on platelet activity will guide further studies evaluating the translation of an~     individual's platelet phenotype to the clinical risk of increased long-term mortality~     following PCI. The outcomes for this study (glucose levels and platelet function) are all~     measured during the hospital stay which averages 1 day.~   "
163965|NCT01419639|"~     This trial studies whether Everolimus is efficacious in treating neurofibromatosis 2.~   "
163966|NCT01419613|"~     The purpose of this study is to find out if a counseling program the investigators have~     developed can help breast cancer survivors adopt a healthier lifestyle.~   "
163967|NCT01419600|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of increasing single doses of AZD8683 administered via inhalation~   "
163968|NCT01419587|"~     This study investigates if using a very low carbohydrate diet during combined chemotherapy~     and radiation therapy is safe and if it can be tolerated by lung cancer patients.~   "
163969|NCT01419574|"~     Background:~      - Treatments for partly blocked carotid arteries are determined by a person s symptoms and by~     tests that show how severe the blockage is. Studies show that the material that blocks an~     artery is more important in spotting future problems than how tight the blockage is.~     Researchers want to develop better imaging studies to find which blockages are more~     high-risk.~      Objectives:~      - To use imaging studies to look at high-risk carotid artery blockages.~      Eligibility:~      - Individuals at least 21 years of age whose ultrasound exams show a major carotid artery~     blockage.~      Design:~        -  Participants will be screened with a medical history, physical exam, blood and urine~          tests, , an ultrasound scan and a magnetic resonance imaging (MRI) scan.~        -  Participants will have ultrasound and other scans to obtain pictures of the arteries.~          The scans will use drugs that may help study doctors get a better picture of the blood~          vessels and blockages.~        -  Participants will have followup phone calls yearly for 3 years. If a participant later~          has surgery to remove the blockage, the surgeon will save part of it for future study.~   "
164033|NCT01418742|"~     Skin toxicity treatment in patients with advanced or metastatic colorectal cancer (mCRC) and~     non-mutated (wild-type) KRAS treated with panitumumab monotherapy after failure of~     fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.~   "
164034|NCT01418729|"~     The purpose of this study is to evaluate the overall survival (OS) in order to assess the~     efficacy and safety of pravastatin as adjuvant treatment to sorafenib.~   "
163970|NCT01419561|"~     Background:~      - KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by Kaposi~     sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People with KICS can have~     severe symptoms. They include fever, weight loss, and fluid in the legs or abdomen. People~     with KICS may also be at risk of getting other cancers associated with KSHV. These cancers~     include Kaposi sarcoma and lymphoma. Because KICS is a newly identified disease, more~     information is needed on how the disease works and what can be done to treat it.~      Objectives:~      - To collect genetic and medical information from people with KSHV inflammatory cytokine~     syndrome.~      Eligibility:~      - Individuals at least 18 years of age who have Kaposi sarcoma herpes virus and symptoms that~     resemble those caused by KICS.~      Design:~        -  Participants will have regular study visits. The schedule will be determined by the~          study researchers.~        -  Participants will provide a complete medical history and have a full physical exam.~          Blood and urine samples will be collected as well.~        -  People with KICS that requires treatment may get new experimental treatments. These~          treatments may include antiviral drugs and chemotherapy drugs, depending on the nature~          of the disease.~        -  Participants will have imaging studies, such as chest x-rays and computed tomography~          scans, to study the tumors.~        -  Bone marrow and lymph node biopsies may be done to collect tissue samples for study.~        -  Participants who have Kaposi sarcoma will have photographs taken of their lesions.~   "
163971|NCT01419548|"~     Background:~      - Paclitaxel and carboplatin are two standard drugs that stop cancer cells from reproducing.~     ABT-888 is an experimental cancer drug that may prevent cancer cells from fixing the damage~     done by chemotherapy drugs. This may make the chemotherapy work better. More tests are needed~     to determine the safety and effectiveness of ABT-888 plus chemotherapy. Researchers also want~     to find the best dose of ABT-888 for people who have kidney or liver problems in addition to~     cancer.~      Objectives:~      - To test the safety and effectiveness of ABT-888 plus carboplatin and paclitaxel in people~     who have both cancer and kidney or liver problems.~      Eligibility:~        -  Individuals at least 18 years of age who have solid tumors that have not responded to~          standard treatment, and who also have kidney or liver problems.~        -  A small group of people with solid tumors and normal kidney and liver function may also~          receive treatment for study comparison purposes.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood and urine tests, tumor samples, tests of liver and kidney function, and imaging~          studies. Participants will also provide a hair sample at the start of the study.~        -  Participants will take one dose of ABT-888 1 week before starting chemotherapy. The two~          chemotherapy drugs will be given on day 3 of a 21-day cycle. Participants will take~          ABT-888 daily for the first 7 days of each cycle.~        -  They will keep a diary to record medication doses and any side effects. They will also~          have frequent blood tests and imaging studies. Participants will provide more hair~          samples on day 3 of cycle 1 before and after having paclitaxel.~        -  Participants will continue treatment for up to 18 weeks as long as the cancer stops~          growing or shrinks and there are no serious side effects. Participants may have the~          option to continue treatment after the study is done.~   "
163972|NCT01419535|"~     Background:~        -  Metabolic syndrome is a name given to a group of factors that tend to occur together.~          These risk factors include central obesity (extra weight around the middle of the body)~          and high blood pressure and blood sugar levels. They also include low levels of HDL~          (good cholesterol) and high triglyceride levels. A person is said to have metabolic~          syndrome if they have three or more of the above risk factors. People with metabolic~          syndrome are at increased risk for type 2 diabetes, stroke, and heart disease.~        -  Cortisol, a hormone produced by the adrenal glands, is an important regulator of~          metabolism. People with central obesity and metabolic syndrome may have higher than~          normal cortisol levels that the body cannot regulate properly. Abnormal cortisol levels~          may play an important role in metabolic syndrome. Mifepristone is a drug that blocks~          cortisol. Researchers are interested in studying its effects on metabolic syndrome.~      Objectives:~      - To study the effects of short-term mifepristone treatment for metabolic syndrome.~      Eligibility:~      - Men and Women between 35 and 70 years of age are overweight or obese, and have abnormal~     glucose and triglyceride levels.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  Participants will be admitted to the metabolic unit at the National Institutes of Health~          Clinical Center for the first 3 days of the study:~        -  Day 1: Body measurements (height, weight, waist, hip, and neck) and blood pressure~          tests. Also, 24 hours of regular blood draws and 24-hour urine collection to monitor~          regular daily cortisol levels.~        -  Day 2: Glucose/insulin infusion test to measure blood sugar levels.~        -  Day 3: Infusion of cortisol-like compounds and then regular blood draws for about 3~          hours to evaluate how cortisol is metabolized.~        -  At the end of Day 3, participants will receive mifepristone or a look-alike capsule to~          take for 7 days at home.~        -  After 7 days, participants will return to the metabolic unit to repeat the Day 1 and Day~          2 study procedures. They will continue to take mifepristone.~        -  One week after the second set of study tests, participants will return for a brief~          physical exam and blood tests.~        -  The study procedures will be repeated after 6 to 8 weeks, with the other study drug.~   "
163973|NCT01419522|"~     Background:~      - Many people who have had a traumatic brain injury have difficulty walking. Training on a~     treadmill is often used to help people with walking difficulties. Supporting a person s body~     weight with a harness while using the treadmill can help improve walking skills in people~     with brain injury. Varying the rate at which people walk on the treadmill may also help more~     than walking at a constant rate. Treadmill training with body weight support or walking at~     different speeds may improve walking skills in people who have had a traumatic brain injury.~     More research is needed to see if one method is better than the other.~      Objectives:~      - To compare the effects of two types of treadmill training in people who have had a~     traumatic brain injury.~      Eligibility:~      - People at least 18 years of age who have had a mild or moderate traumatic brain injury at~     least 6 months ago and have mild or moderate walking difficulty.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          take a basic walking test (not on a treadmill).~        -  Participants will be divided into two groups. The first group will have treadmill~          training at a constant speed. The second group will have treadmill training at different~          speeds. All participants will wear a support harness while walking on the treadmill.~        -  At the first training visit, participants will have a gait assessment with different~          tests of walking. Then they will have a treadmill walking session.~        -  After the first visit, participants will return twice a week for 6 weeks for treadmill~          training sessions (visits 3 through 12). They will also have grip strength and walking~          tests.~        -  At the end of 6 weeks, participants will have a final treadmill training session, and~          will have a gait assessment exactly like the one in the first training visit.~        -  At 6 months after the final session, participants will have a followup visit with a~          final gait assessment.~   "
163974|NCT01419509|"~     RATIONALE: DNA analysis of tumor, blood, and bone marrow may help doctors predict if the~     disease has been disseminated.~      PURPOSE: This research trial studies DNA tests in detecting disseminated disease in tumor,~     blood, and bone marrow samples from patients with rhabdomyosarcoma.~   "
163975|NCT01419496|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about cancer and development of drug resistance in patients.~      PURPOSE: This research trial is studying proteins that may promote chemotherapy resistance in~     samples from patients with acute myeloid leukemia.~   "
163976|NCT01419483|"~     This study investigates if using a very low carbohydrate diet during combined chemotherapy~     and radiation therapy is safe and if it can be tolerated by patients.~   "
163977|NCT01419470|"~     safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044~     in premature ejaculation~   "
163978|NCT01419457|"~     This study is designed to determine the pharmacokinetics of favipiravir in volunteers with~     hepatic impairment and in healthy control volunteers.~   "
164001|NCT01419158|"~     Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic~     obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD~     is not as rare as originally thought and undetected AATD may account for COPD in some~     patients. This study was designed to evaluate the frequency of undetected AATD in a~     population reporting to academic pulmonary function testing facilities who meet criteria for~     the diagnosis of COPD. All individuals meeting GOLD criteria for COPD will be consented and~     offered free testing for AATD. The results will help identify the percent of those with COPD~     who have undetected AATD.~   "
164002|NCT01419145|"~     A multicentre, open, randomized phase II study comparing a multimodal intervention (oral~     nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer~     care.~   "
163979|NCT01419444|"~     The purpose of this research is to determine whether treatment of voice disorders can be~     provided just as effectively using telemedicine as it can using on-site, traditional therapy.~     An exercise protocol for improving airflow with voicing has been demonstrated to be effective~     in a prior UAMS investigation (Protocol 107454). These exercises are used as part of the~     normal clinic routine at UAMS working with individuals with voice problems. The three~     exercises used are: gargling with and without voicing; cup bubble blowing with and without~     voicing; and, stretch and flow exercises, which involves the use of a piece of tissue to~     provide visual biofeedback on the ability to use proper airflow with voicing. The purpose of~     the exercises is to increase airflow and breathiness in the voice and reduce muscle tension.~     In addition, patients will be taught to use a confidential voice or gentle voice during~     speaking.~      The investigators voice patients come from all over the state and many cannot return for~     regular treatment. Developing a way to provide treatment to them closer to home could greatly~     improve quality of care and quality of life. Twenty participants will participate for 12~     sessions each. All participants will be evaluated at UAMS before and after treatment as part~     of standard care and will, upon consent, be randomized to receive treatment via telemedicine~     at an AHEC site or at UAMS Medical Center. Homework will be provided along with log sheets.~     Results of airflow measures using an airflow-recording device (Viasys, KAY/PENTAX) pre- and~     post treatment will determine whether telemedicine results are equal to results of~     traditional, on-site treatment. The investigators hypothesize that results from treatment~     using telemedicine will be equivalent to results for onsite, traditional treatment.~   "
163980|NCT01419431|"~     Pro-inflammatory responses following laparoscopic surgery.~   "
163981|NCT01419418|"~     Specific Aims: To delve into the complex phenomena of living with Peripheral Arterial Disease~     (PAD), and to investigate the patients' perspective of the factors that affects their~     decisions regarding management of their PAD.~      a) Utilize a qualitative approach to uncover factors that patients perceive support the~     management of their condition utilizing a purposive sampling of Peripheral Arterial Disease~     patients.~        1. To determine what they believe to be effective tools to support themselves to improve~          their condition.~        2. To determine from the patient's perspective if adherence to prescribed medical regimes~          are important for them to improve their PAD outcomes.~        3. To describe the patient factors of those who are self reported adherent compared to~          those who are not or unable to their prescribed regimen.~   "
163982|NCT01419405|"~     In this experimental study on healthy volunteers we explored the effect of pregabalin alone~     and in combination with remifentanil on acute experimental pain and ventilatory function.~   "
163983|NCT01419392|"~     The purpose of this study is to determine whether sildenafil citrate is effective in~     improving uterine artery blood flow and oxidative stress in patients with unexplained~     recurrent miscarriages~   "
163984|NCT01419379|"~     This study is designed as a multicenter, prospective and retrospective and descriptive~     epidemiology study.~      This study is planned to evaluate 2 years of exacerbation in COPD patients and to investigate~     correlation of COPD disease progress and its exacerbation.~      This study is designed with 6 months of subject enrollments, 12 months of retrospective~     study, and 12 months of prospective study. Hence, each patient will be participating in the~     study for 12 months, while the actual data collections from the patients will take a total of~     24 months.~      The statistical analysis of this study will be done twice, at the completion of 1 year~     retrospective data collection and at the completion of next 1 year follow-up.~      The 1st statistical analysis of retrospective study includes exacerbation rate, duration of~     hospitalization for exacerbation and lung function test for the past 1 year from the~     enrollment and comorbidities, COPD assessment (CAT) and COPD medication at the enrollment~     will be analyzed.~      The 2nd statistical analysis of prospective 1-year follow-up includes changes in exacerbation~     rates, comparison of lung function test results, comorbidities, COPD assessments (CAT) and~     COPD medications of retrospective and prospective studies for the 2 years as well as~     mortality rate.~   "
163985|NCT01419366|"~     Objective:~      To compare the rate and extent of release of the drug substance from the two tablet~     formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and~     the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of~     at least 7 days.~      Study Design:~      Randomized, open label, two treatment, two period, two sequence, single dose, crossover study~     in healthy human adult subjects~   "
163986|NCT01419353|"~     The purpose of this study is to determine if pretreatment with Estrogen can assist in the~     planning and programming of In Vitro Fertilization treatments.~   "
163987|NCT01419340|"~     Objective:~      To compare the rate and extent of release of the drug substance from the two tablet~     formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and~     the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of~     at least 7 days.~      Study Design:~      Randomized, open label, two treatment, two period, two sequence, single dose, crossover study~     in healthy human adult subjects~   "
163988|NCT01419327|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients in hemodialysis who received Fosrenol for~     hyperphosphatemia. The objective of this study is to assess safety and efficacy of using~     Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.~   "
164003|NCT01419132|"~     High values of cardiac troponin (Ct) in acute heart failure (ADHF) identify patients (pts) at~     higher risk and worsened prognosis. A Ct increase during therapy indicates the need for more~     appropriate intervention, aimed at compensating cardiac disease and effectively minimizing~     myocardial wall stress and subsequent cytolysis. This study evaluated the effects of an~     intravenous high-dose of furosemide with or without small-volume hypertonic saline solution~     (HSS)on myocardial cytolysis in ADHF pts.~   "
164004|NCT01419119|"~     The purpose of this study is to determine the efficacy of different doses of vitamin D in~     persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.~   "
164005|NCT01419106|"~     This study is designed to determine if there is any relationship between performing an~     abdominal ultrasound on patients who present with hypotension and their clinical outcomes (as~     measured by 7, 30 day and discharge mortality).~   "
163989|NCT01419314|"~     WHAT IS THE PURPOSE OF THIS STUDY? The investigators want to know if wearing a pair of~     splints at night works to bring the pain down and help you sleep better (in people living~     with HIV/AIDS related neuropathy).~      HOW MANY PEOPLE WILL PARTICIPATE? About 58 to 88 people will take part in this study at the~     Harris County Hospital District (HCHD).~      WHAT WILL HAPPEN DURING THIS STUDY? As a participant, you will be assigned to one of two~     treatment groups. In one group, you will be asked to wear leg splints at night and the other~     you will wear the liners of the splints only.~      You will be asked to answer questions about how well you sleep, how long you sleep, and about~     your discomfort at the legs. The researcher will be there to help, but the investigators want~     you to answer the questions on your own if you can. You will be asked to reach forwards~     standing next to a wall and to walk for 6 minutes after that. The tests will de done in~     random order. The sessions will be done at the beginning, at week three and week six. You~     should finish all of the testing and questionnaires in an hour or less, for a total of three~     hours over six weeks in the investigators clinic.~      You will receive instructions on how to use the splints with liners or the liners alone at~     home. You will be asked to wear them at night only for the next 6 weeks. Finally, the~     principal investigator will contact you weekly by phone, to discuss issues of comfort and~     your ability to adhere to the instructions provided.~   "
163990|NCT01419301|"~     This study focuses on stress, cognition, mood and fatigue and its effect on medication~     compliance. Medication compliance is measured by the weight of discarded needles. The~     investigators will be administering neuropsychological testing at baseline and the final~     visit. The subjects will complete self-report assessments during their 8 weeks in the study.~      Group A will have additional weekly phone support for meditation, while Group B will have~     meditation training only.~   "
163991|NCT01419288|"~     Many people with a leg amputation have difficulty walking even after they have finished their~     rehabilitation. The purpose of this study is to see if a large amount of walking practice on~     a treadmill can improve functional abilities.~   "
163992|NCT01419275|"~     Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke~     patients~   "
163993|NCT01419262|"~     Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods.~     Vitamin D levels are alarmingly low in many North American children. Several health issues~     have been linked with low vitamin D. These include colds caused by viruses and asthma~     attacks. However, no study has determined whether vitamin D supplementation can reduce the~     risk of these conditions in young children where they are most common and most severe.~      The goals of this study are to determine whether wintertime high dose vitamin D~     supplementation of preschoolers can prevent colds and asthma attacks. The investigators also~     aim to work out how much money would be saved by the health care system and society if~     preschoolers were routinely supplemented with Vitamin D during the winter. The investigators~     believe that preschoolers receiving 'high dose' vitamin D supplementation during the~     wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and~     will be less likely to use the medical system and keep their parents away from work.~   "
163994|NCT01419249|"~     PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to~     confirm that some genes can be used to predict how well a subject diagnosed with idiopathic~     growth hormone deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with~     recombinant human growth hormone (r-hGH).~   "
163995|NCT01419236|"~     The purpose of this study is to see if testosterone solution 2% can impact symptoms of~     ejaculatory dysfunction in men with low testosterone.~   "
163996|NCT01419223|"~     This is an exploratory qualitative interview study being conducted with a primary objective~     of examining perceptions held by active military and veterans regarding help-seeking~     attitudes and mental health beliefs which influence the decision to consent or decline~     participation in Post-Traumatic Stress Disorder (PTSD) or Traumatic Brain Injury (TBI)~     clinical trials. Active duty military and/or veterans aged 18 years and older who consent to~     participate (N = 50), or have recently declined participation (N = 50), in an INTRuST~     affiliated outpatient clinical trial for deployment-related PTSD or TBI will be recruited.~     Participants who consent to participate in an INTRuST clinical trial (Group 1) will be~     interviewed once at the beginning the of the clinical trial, and again following~     participation in the trial. Participants who decline participation in an INTRuST affiliated~     outpatient clinical trial (Group 2) will be interviewed once. For participants in both~     groups, study participation will initiate within 1 month of referral to study. Total duration~     of study participation is based on the specific clinical trial that the participant is~     recruitment from; the longest trial is estimated to be 24 weeks or less. Semi-structured~     qualitative individual interviews will be conducted to carry out a thematic analysis of the~     data exploring familial, social and institution-level constructs which may influence the~     subjective experience of the research treatment process.~   "
163997|NCT01419210|"~     The purpose of this study is to find out if complementary and alternative medicines (CAM)~     should be included with traditional therapy for women with ovarian cancer. Some of the~     alternative medicines include non-traditional drug and herbal therapies along with dietary~     and nutritional strategies. Only a few of these alternative medicines have been tested with~     women with ovarian cancer.~   "
163998|NCT01419197|"~     This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy~     and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's~     choice in participants with metastatic or unresectable locally advanced/recurrent human~     epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will~     be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days~     or treatment of the physician's choice. Participants continue to receive study treatment~     until disease progression or unacceptable toxicity occurs. This study is also known under~     Roche study protocol number BO25734.~   "
163999|NCT01419184|"~     This was a real-world, prospective, open-label, multicenter study in which participants were~     randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of this~     study is to compare infection-related hospital length of stay, along with a number of~     participant-reported outcomes, between participants with complicated skin and soft tissue~     infection treated with daptomycin and vancomycin.~   "
164000|NCT01419171|"~     The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary~     Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery~     lesion.~   "
164007|NCT01419080|"~     An estimated 8 million individuals in America are affected by peripheral arterial disease~     (PAD), blockages of the leg arteries that can cause excruciating calf pain when walking. PAD~     can have a tremendous impact on patients' quality of life. It is also associated with high~     rates of heart attacks and premature death. While there are a number of treatments, there~     have been few previous studies that have prospectively examined treatment patterns for PAD or~     sought to systematically identify opportunities to improve care. Most importantly, there have~     been no rigorous studies examining the impact of the disease from patients' perspectives -~     their symptoms, function and quality of life - as a function of different patient~     characteristics and treatments. The PORTRAIT study (Phase II) will systematically document~     the treatments and health status (symptom, function and quality of life) outcomes of 840 US~     patients over the course of one year (assessments at baseline, 3, 6, and 12 months) from 10~     centers to address these gaps in knowledge. It will illuminate whether disparities in~     treatment or health status outcomes exist as a function of patients' age, gender, race,~     socioeconomic or psychological characteristics. PORTRAIT will substantially elevate the field~     and identify critical gaps in the way PAD is currently managed, including potential~     disparities in care, so that the quality of care can be improved.~   "
164008|NCT01419067|"~     The goal of this study is to determine the feasibility and safety of treating patients with a~     brain tumor known as craniopharyngioma with limited surgery and a 5mm clinical target volume~     margin in combination with proton therapy. Proton therapy will be indicated for patients with~     diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection).~     Irradiated patients will undergo a series of evaluations designed to evaluate the effects of~     proton therapy. Similar evaluations will be performed on patients treated with radical~     surgery. Proton therapy will include 30 treatment fractions administered 5 days per week.~     Weekly imaging will be a requirement to monitor for cyst expansion and target volume~     deformation.~   "
164009|NCT01419054|"~     Healthcare associated infections increase morbidity and mortality among all hospitalized~     patients, especially in those who are immunocompromised, in both developed and in countries~     with limited resources. However, when resources are limited, infection prevention and control~     measures are often overlooked by personnel and institutions. Hand hygiene has been shown~     numerous times to be the most effective way to prevent infections in the healthcare setting.~     In Unidad Nacional de Oncologia Pediatrica (UNOP) in Guatemala City, Guatemala, there have~     been several infrastructural improvements and periodic education and promotion activities.~     Still, acceptable hand hygiene compliance has not yet been sustainably achieved. The~     investigators wish to study reasons why staff at UNOP do or do not practice hand hygiene when~     it is indicated through the use of focus groups and interviews.~   "
164010|NCT01419041|"~     The present study is being conducted to evaluate whether or not severe renal impairment has~     an effect on crizotinib Pharmacokinetics.~   "
164011|NCT01419028|"~     This study aims to characterize the natural history of patients with severe perinatal or~     infantile onset HPP.~   "
164012|NCT01419015|"~     A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the~     20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral~     delivery system, and crimper accessories. The trial includes a premarket pivotal cohort to~     evaluate the system performance as well as a post market clinical follow-up phase involving~     long term follow-up of all patients to evaluate the safety of investigational devices up to 5~     years.~   "
164013|NCT01419002|"~     Net-Pac investigates if radiation prior to surgical resection improves survival in patients~     with pancreatic head cancer without metastases.~   "
164014|NCT01418989|"~     This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra~     (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy~     volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab).~     The anticipated time of study duration is 28 days.~   "
164015|NCT01418976|"~     This is a case series study evaluating the feasibility and dosage of Intensive Mobility~     Training (IMT). Twelve participants with chronic, mild-to-moderate, Traumatic Brain Injury~     (TBI) causing significant locomotor impairment, who meet these specific criteria, will be~     recruited. Location and nature of neural insult will be determined by multimodal Magnetic~     Resonance Imaging (MRI) exam. All participants will receive 3 hours of rehabilitation per day~     for 20 days, focusing on gait and balance. Locomotion and balance will be comprehensively~     tested prior to IMT, after 10 days of IMT, and then again after the full dose of IMT. This~     study will determine the feasibility of this intervention in the population of TBI patients,~     allow an estimate of effect size and provide initial information on possible neural~     predictors of success. Furthermore the investigators will be able to determine whether the~     dosage of 10 days is sufficient or whether significant improvements are made with 20 days of~     the intervention.~   "
164016|NCT01418963|"~     This two-part, randomized, double-blind, placebo-controlled study will assess the safety,~     pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of~     RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each~     subject.~   "
164017|NCT01418950|"~     Pregnant women who receive study counseling which includes gestational age specific written~     information in addition to the verbal counseling will have better knowledge of problems and~     outcomes of prematurity than women who receive standard counseling which consists of only~     verbal counseling.~   "
164018|NCT01418937|"~     This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV~     vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and~     received a placebo in the HPV-001 (NCT00689741) study.~   "
164019|NCT01418924|"~     The aim of this study is to determine whether plasma sclerostin levels is affected by sex~     hormones during menstrual cycle. Blood samples will be obtained at the beginning (between~     2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. Serum~     sclerostin, estradiol, progesterone and testosteron levels will be measured blindly by only~     one investigator~   "
164056|NCT01418443|"~     Objective:~      To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release~     Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of~     Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7~     days.~      Study Design:~      randomized, open label, two treatment, two period, two sequence, single dose, crossover study~     in healthy human adult subjects~   "
164020|NCT01418911|"~     This study will expand the understanding of factors associated with adherence to self care~     and the diabetes control among diabetes type 2 patients. The theoretical framework of the~     study incorporates central variables from two theoretical models: a cognitive model of health~     behavior - Health Belief Model, and the Stress and Coping model. The study is innovative in~     its focus on the association between the patient's attachment style and adherence to self~     care and diabetes control, a topic less studied among diabetes patients, in addition to~     cognitive, social and emotional variables. Further emphasis is upon a comparison of the study~     model between males and females.~   "
164021|NCT01418898|"~     This study will follow a randomized, double-blind, placebo-controlled, parallel-group design~     to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve~     nutrient status and iron deficiency in young children compared to an unfortified control~     beverage.~   "
164022|NCT01418885|"~     SIVD is characterised by extensive cerebral white matter lesions (WML) and lacunar infarcts~     in deep grey and white matter structures. The relationship between SIVD and cognition is~     unclear, in part because of methodological inconsistencies across studies.~      Diffusion tensor imaging (DTI) is a non-invasive water diffusion technique and can be used~     for quantitatively measuring the degree and directionality of the displacement distribution~     of water molecules. 1H magnetic resonance spectroscopy (1H-MRS) is a valuable tool for the~     assessment of several biochemical compounds in the brain in vivo, such as N-acetylaspartate~     (NAA), myoinositol (mI), Choline (Cho) and Creatine (Cr). There were few reports considering~     the relationship among MRS, DTI and cognitive impairment of SIVD. Combining MRS with DTI may~     provide valuable information about the pathophysiological changes underlying DTI~     abnormalities and help us to better understand the SIVD process. It has been proposed that~     the pathogenesis of SIVD related to cerebral small vessel disease caused by various~     mechanisms. Inflammation plays an important role in the pathogenesis of SIVD. The examination~     of inflammatory markers in relation to VaD might be benefit to early treatment.~      In this study we applied neuropsychological tests, conventional MRI scanning, DTI, 1H-MRS~     techniques and inflammatory markers to estimate neuropsychological profile and white matter~     characteristics of imaging in patients with SIVD. Moreover, the relationship between WML and~     cognitive function impairment was also investigated. It could be possible to gain reliable~     data which is benefit to early diagnosis and treatment of cognitive impairment in SIVD.~   "
164023|NCT01418872|"~     AIM: To evaluate the effectiveness of two strategies in cardiovascular risk in children 2º~     grade in the community of Madrid.~      DESIGN: cluster-randomized trial with blinded evaluator SCOPE AND SUBJECTS OF STUDY: Children~     of both sexes enrolled in 2º grade in public schools in the community of Madrid. Rate~     exclusion criteria INTERVENTION: Schools were randomly assigned to two groups: an~     experimental group that the investigators organized a concert teaching focused on messages~     cardio, a second group or control group to which they will host a healthy breakfast as it has~     been offering the Community of Madrid .~      MEASUREMENTS: The primary end result is the increase of correct answers on a standardized~     test to be administered before and after the activity.~      Secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall~     weight and center from before the intervention at 6 months of it.~   "
164024|NCT01418859|"~     The purpose of the research is to evaluate the effect of additional chemotherapy in~     postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion~     or tumor thrombi in the vascular system).~   "
164025|NCT01418846|"~     The purpose of this study is to investigate the intra-saliva penetration of voriconazole in~     different subpopulations. The goal is to develop, optimize and validate an easy, non-invasive~     and painless procedure for Therapeutic Drud Monitoring of voriconazole that can be used in~     children, ambulatory patients and in patients in whom blood drawing is difficult.~   "
164026|NCT01418833|"~     The first goal of this study is to map all the subtherapeutic, therapeutic and~     supratherapeutic voriconazole plasma levels in the University Hospitals Leuven. The second~     objective is to optimize and validate guidelines for dose modifications in patients with too~     low or high plasma concentrations and to investigate if the same guidelines can be used in~     different patient populations.~   "
164027|NCT01418820|"~     Visual field areas, which are not absolutely blind, are hypothesized to have some residual~     capacities that constitute their potential for vision restoration. Vision restoration can be~     achieved by varies methods including behavioral training and electrical brain stimulation~     such as transcranial direct current stimulation (tDCS) and repetitive transorbital~     alternating current stimulation (rtACS) which are able to influence the excitability and~     activity of cortical areas.~      It is hypothesized that transorbital alternating current stimulation (tACS) can improve the~     residual field of vision in patients with post-chiasmatic lesions.~   "
164028|NCT01418807|"~     We hypothesise that pain at minilaparoscopy for gynecologic disease is reduced when~     transvaginal rather than transumbilical specimen extraction is accomplished. This would be~     due to the avoidance of a 10-mm port in the umbilicus. Visual analogue scale score of~     post-operative pain will be obtained and patients satisfaction will be asked at the 2-month~     postoperative visit.~   "
164029|NCT01418794|"~     Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our~     previous study showed that polymer-free rapamycin-coated stents brings dose-dependent~     reduction in restenosis. This prospective, multicenter, randomized controlled clinical trials~     aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse coronary~     artery disease.~   "
164030|NCT01418781|"~     We will study whether the health care costs and health utilities differ in patients with gout~     and those without gout and whether they differ between those with more severe versus less~     severe gout~   "
164031|NCT01418768|"~     The purpose of this study is to determine if there is a change in the CAT-score after an~     inpatient rehabilitation of three weeks and if it correlates with other common parameters.~   "
164032|NCT01418755|"~     Recently an articular cartilage repair has been given much attention in the orthopaedic~     field. Cartilage regeneration capacity is very limited. Optimal approach seems to be a~     delivery of natural growth factors. Autologous platelet-rich plasma (PRP) contains~     proliferative and chemoattractant growth factors. The objective of the present study was to~     determine if PRP can increase tibiofemoral cartilage regeneration and improve knee function.~   "
164035|NCT01418716|"~     The TRANSIT program is a program to TRANSform InTerprofessional clinical practices to improve~     cardiovascular prevention in primary care. It addresses priorities in primary care relevant~     to the Chronic Care Model (Wagner 2001): self-management support, delivery-system design, and~     management of clinical information.~      The program includes :~        -  a case manager to coordinate and provide care and follow up;~        -  clinical protocols and tools to support interprofessional and systematic follow up;~        -  training for clinicians;~        -  patient's personalized cardiovascular health booklet;~        -  tools to promote group sessions for patient education on cholesterol, hypertension, and~          diabetes.~      The general OBJECTIVE of this trial is to evaluate and compare two STRATEGIES for~     implementing the TRANSIT program in Family Medicine Groups (FMGs):~        1. facilitation, and~        2. passive diffusion.~      Passive diffusion is the usual strategy where clinicians implement an intervention program by~     themselves. Facilitation is a strategy whereby a facilitator provides support to a team of~     clinicians to help them introduce the changes required to implement the program into~     practice.~      The hypothesis is that facilitation will be more efficacious to implement the program than~     passive diffusion:~        -  it will enhance the provision of cardiovascular preventive care;~        -  it will enhance interprofessional collaboration;~        -  it will enable more efficaciously the implementation of new clinical processes;~        -  it will improve patient clinical outcomes;~        -  it will cost more in the short term, but will have positive economic impact in the long~          term;~        -  there will be less undesired effects of all types related to implementation.~      To test the hypothesis, we assess the efficacy of the implementation strategies to enhance~     interprofessional collaboration and better support patients in the management of their~     conditions. Impact on provision of care, interprofessional collaboration, clinical processes,~     and patient clinical outcomes (values, therapeutic targets, and lifestyle habits) will be~     evaluated. Moreover, the implementation cost related to each strategy will be estimated.~      We complement the trial with qualitative methods to document the perceptions of clinicians,~     facilitators, patients and members of the family regarding the TRANSIT program, the~     implementation strategies and the observed changes in the clinical practices and outcomes.~   "
164036|NCT01418703|"~     In this protocol the investigators plan to demonstrate the feasibility of a modular insulin~     management system based on continuous glucose monitoring and targeted towards the avoidance~     of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol is~     designed to challenge the insulin management system with meals and mild exercise, so as to~     demonstrate its capacity to avoid large glucose excursion with changing metabolic state. This~     system is designed to both~        -  monitor the meal boluses of the patient and correct it in case of observed/predicted~          under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and~          subjective knowledge of the meal amount, a precise understanding of the subject's day to~          day insulin treatment, continuous glucose monitoring, and past insulin injections;~        -  predict and avoid hypoglycemic events, based on continuous glucose reading and past~          insulin injection.~      The investigators plan to enroll 12 adult Type 1 Diabetes Mellitus (T1DM) patients (expected~     retention 10/12) and compare glucose control performances under two treatments: standard vs.~     the new insulin management system. The protocol will include a total of 6 admissions per~     subject (4 out-patients and 2 in-patients): screening, effort test, CGM insertion 1,~     inpatient 1, CGM insertion 2, and inpatient 2. During the 24h inpatient admissions, the~     patients will be challenged with 30 minutes of mild exercise and 3 meals, insulin coverage of~     these events will vary depending on the chosen treatment, each subject will be exposed to~     both studied treatments (repeated measure design).The order of treatment during the inpatient~     admissions will be randomized.~   "
164037|NCT01418690|"~     Adequate tissue oxygenation is required for effective white blood cell function and~     bactericidal activity. Decreased tissue oxygenation is a risk factor for perioperative wound~     infections. Regional anesthetic techniques result in a functional sympathetic block and may~     increase tissue oxygenation. The purpose of this study is to evaluate changes in tissue~     oxygenation using a non-invasive Near-infrared spectroscopy (NIRS) device. The current study~     will evaluate changes in tissue oxygenation following regional anesthetic techniques~     (peripheral nerve blockade and neuraxial techniques such as caudal block) in pediatric~     patients).~      Regional anesthesia will induce a sympathetic blockade and improve tissue oxygenation.~   "
164038|NCT01418677|"~     This is an open-label non-randomized study in subjects with advanced or metastatic solid~     tumors who are no longer responding to available therapy. HALAVEN will be administered to~     subjects on Days 1 and 8 of a 21-day cycle.~   "
164039|NCT01418664|"~     We hypothesized that vitamin D supplementation during pregnancy can prevent adverse pregnancy~     outcome.~   "
164040|NCT01418651|"~     Participants will undertake a 12-week, open-label study of milnacipran in a~     well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and~     older to investigate the short-term efficacy and safety of this drug in the elderly~     population. The investigators hypothesize that milnacipran will be effective in treating~     fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the~     absence of pre-existing blood pressure abnormalities and other serious medical conditions.~   "
164041|NCT01418638|"~     Objective There is growing evidence showing a relation between depression, metabolic~     syndrome, diabetes, cardiovascular disease (1), serum lipid profile (2,3) and body weight~     (4), as well as the effects of some of the antidepressant medications on these various~     conditions and profiles.~      The aim of the study is to examine the influence of antidepressant medications on the~     metabolic profiles (5) of patients suffering from Major Depressive Disorder (MDD).~      Group of patients:~      30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.~      Research Design and Methods:~      Research duration will be 8 weeks. Patients meeting the inclusion criteria will be recruited~     after being diagnosed with MDD and having undertaken the HDRS. A follow-up HDRS will be taken~     at weeks 4 and 8. The psychiatric evaluation will be held by a resident in psychiatry.~      The following metabolic parameters will be examined at base-line and at the end of the 8~     weeks:~      Weight, height, waist circumference, body mass index (BMI: (Weight in Kg/(Height in~     meters)2), sitting blood pressure (after 3 minutes of sitting).~      Serum lipid profile (performed in Ziv hospital's chemistry lab): Low density lipoprotein~     cholesterol, High density Lipoprotein cholesterol, Triglycerides, Total cholesterol,~     Apolipoprotein level (Apo AI, Apo B, Apo E, Apo AII).~      Fasting glucose and insulin blood levels, in order to evaluate insulin-release and~     resistance, according to the following formulas:~      Insulin Resistance:~      HOMA IR=Fasting glucose (mg/dL)x Fasting insulin (mmol/L)/405~      Insulin Release:~      HOMA-β={360xfasting insulin (mmol/L)}/{glucose(mg/dL)-63} Serum oxidative stress parameters~     according to the F2-Isoprostane kit will be measured.~      Malonylaialdehyde (MDA) content in serum will be analyzed by the thiobarbituric acid reactive~     substances assay, which measures malondialdehyde equivalent (13). Conjugated dienes will be~     measured at 234nm (14, 15).~   "
164042|NCT01418625|"~     Objective:~      The Bioequivalence studies were performed to compare the rate and extent of release of the~     drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride~     Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR®~     (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc.,~     USA.~      Study Design:~      Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose~     Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test~     formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule~     (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers~   "
164057|NCT01418430|"~     The purpose of this study is to determine the safety of the combination of CHOP plus~     daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.~   "
193716|NCT01027923|"~     In this phase I extension study, the investigators seek to test the safety of both higher~     doses of plerixafor as well as intravenous dosing to maximize inhibition of the target,~     CXCR4.~   "
164043|NCT01418612|"~     Objective:~      The Bioequivalence studies were performed to compare the rate and extent of release of the~     drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride~     Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR®~     (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc.,~     USA.~      Study Design:~      Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose~     Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test~     formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule~     (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers~   "
164044|NCT01418599|"~     Objective:~      Primary objective of the present study was to assess the relative bioavailability of two~     formulations of Extended Release Alfuzosin 10 mg under Fed conditions, in healthy adult male~     subjects after an oral administration with 7 days washout period.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
164045|NCT01418586|"~     Objective:~      Primary objective of the present study was to assess the relative bioavailability of two~     formulations of Extended Release Alfuzosin 10 mg under Fasted conditions, in healthy adult~     male subjects after an oral administration with 7 days washout period.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
164046|NCT01418573|"~     The objective of the study is to show post-prandial benefits of Palaeolithic-type meals as~     compared to a meal constructed along the lines of the WHO dietary recommendations.~   "
164047|NCT01418560|"~     The purpose of this study is to observe the incident of uremia and dialysis requirement after~     renal sympathetic modification using THERMOCOOL® catheter in patients with chronic renal~     failure, and evaluate safety and efficacy of the intervention.~   "
164048|NCT01418547|"~     Objective:~      to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER~     Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA~     under fed condition. Dosing periods were separated by a washout period of 8 days.~      Study Design:~      randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects~   "
164049|NCT01418534|"~     Objective:~      to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER~     Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban,~     USA. Dosing periods were separated by a washout period of 8 days.~      Study Design:~      randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects~   "
164050|NCT01418521|"~     The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to~     show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in~     terms of safety and effectiveness as the commonly used albumin based solution for volume~     replacement after the surgery.~   "
164051|NCT01418508|"~     The purpose of this study is to determine whether low protein diet and very low protein diet~     supplemented keto-/amino acid is effective in preventing the progression of chronic kidney~     disease (CKD , stage 3b and 4).~   "
164052|NCT01418495|"~     This research trial is studying how Ch14.18 acts in the body of younger patients with~     high-risk neuroblastoma. Studying samples of blood from patients with cancer receiving~     Ch14.18 may help doctors learn more about how this drug is used by the body to develop better~     ways to give the drug to potentially improve its effectiveness and lessen its side effects.~   "
164053|NCT01418482|"~     The investigation is designed as an open, non-controlled, post-marketing investigation.~     Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will~     be included. The subject is allowed to have more than one burn on the body but only one~     should be included in the investigation. Each subject will be followed/assessed according to~     normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired~     treatment effect is obtained if that occurs earlier. All dressing changes will be done~     according to clinical routine and will follow the IFU (instruction for use). All dressing~     changes will be registered in a dressing log. Additional compression bandaging, gauze wrap,~     or such are allowed and should be reported as well~   "
164054|NCT01418469|"~     Studies on resting human muscle show that ingestion of the branched-chain amino acids (BCAA):~     leucine, valine and isoleucine have an anabolic effect on muscle protein metabolism. However,~     the effects of BCAA intake on protein metabolism during exercise are less clear. When BCAA~     were supplied as single amino acids, without other amino acids and/or carbohydrates, no~     effects were observed on protein kinetics. On the other hand, ingestion of BCAA during~     running appeared to reduce the catabolic effect of running on muscle protein metabolism.~     These experiments were all performed with mixtures of the BCAA with or without carbohydrates~     but not in the form of complete meals with food protein as a basis. Therefore, it is still~     unknown whether a protein meal, containing a substantial amount of BCAA is beneficial during~     exercise by inducing an anabolic effect.~      Whey and Casein protein contain a substantial amount of BCAA in contrast to Soy protein.~     Therefore, it is hypothesized that milk-based proteins are a better and more physiological~     source of BCAA during exercise and will lead to more protein anabolism. Most of the available~     studies have been carried out in young and fit humans but there are hardly any data are~     available in the increasing population of the elderly. Therefore it is still unknown whether~     a BCAA rich protein meal can enhance the anabolic effect of exercise in older individuals.~      Besides sarcopenia, a substantial part of the elderly is suffering from a chronic systemic~     disease such as chronic obstructive pulmonary disease (COPD). COPD represents an important~     health care problem. COPD is the fourth leading cause of death and will be the third leading~     cause worldwide in 2020. Besides the local impairment, COPD is a chronic wasting disease,~     associated with alterations in intermediary metabolism. Substantial disturbances have been~     found in BCAA (and related) metabolism in these patients at rest and during exercise. It~     might therefore be of clinical relevance to study the metabolic effects of BCAA rich protein~     meals in patients with COPD at rest and during exercise.~   "
164055|NCT01418456|"~     The overall objective is to investigate whether antibiotics in the treatment of clinically~     clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence~     of infection and therefore lead to improved outcomes This is a single centre study in which~     patients with either type 1 or 2 diabetes mellitus, who consecutively present to the Diabetic~     Foot Clinic [DFC] with clean neuropathic (NU) or ischaemic (IU) diabetic foot ulcer without~     clinical signs of infection will be invited to take part and will express their willingness~     to take part in the study by signing a consent form.~        -  All patients will be treated and followed up in the DFC at King's College Hospital.~          Patients will be randomised into two groups: an antibiotic group and a control group.~        -  The antibiotic group will receive standard treatment along with antibiotics.~        -  The control group will have standard treatment alone.~        -  Patients from both groups will be reviewed at weekly intervals for a period of 20 weeks.~        -  Patients will be removed from the study if they develop clinical signs of infection or~          if their ulcer heals prior to 20 weeks but will be followed up via routine practice for~          eventual outcomes~   "
164058|NCT01418417|"~     Objective:~      To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release~     Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of~     Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7~     days.~      Study Design:~      randomized, open label, two treatment, two period, two sequence, single dose, crossover study~     in healthy human adult subjects~   "
164059|NCT01418404|"~     In literature review, thermal stimulation (TS) intervention is effective in facilitating~     upper extremity functional recovery in stroke patients. In addition, several functional MRI~     studies have indicated that thermal stimuli promoted activation in the premotor and motor~     cortices of healthy participants. These imply the possibility of TS in cortical~     reorganization. However, there were no studies exploring the relationship of the TS~     intervention and cortical reorganization. By the functional recovery of stroke patients,~     findings of brain image and brain mapping, it could enhance the understanding the TS~     influences on brain reorganization. Regarding with clinical application of the TS~     intervention for improving functional performance of upper extremity in participants with~     stroke, the best parameters of TS intervention in clinical practice have not been decided.~     Therefore, this five-year study recruited three groups of stroke patients (acute, sub-acute,~     chronic) undergoing TS intervention with different parameters. Functional scales, kinematic~     data, brain image were taken in several timelines as outcome measures.~   "
164060|NCT01418391|"~     Transversus abdominis plane block (TAP block) is a new regional block for abdominal wall.It~     had been reported the effect of post-operative pain control in minor abdominal surgery, such~     as inguinal hernia repair and appendectomy. On the other hand, because of the accurate of the~     pre-operative images, the minimal laparotomy for colon cancer was accomplished. Thus, the~     purpose of this study is to investigate the effect, such as analgesic effect, hemodynamic~     stability, and post-operative morphine consumption, of TAP block in minimal laparotomy.~   "
164061|NCT01418378|"~     This study will compare two very similar designs of knee replacement device. One device~     (Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been modified~     to enhance/accommodate higher flexion. The original device has been in widespread clinical~     use with excellent results since 1996 and this study will determine whether the design~     modifications of the newer device add further value. The newer device has been in clinical~     use with good short-term(unpublished) outcomes since becoming commercially available in~     January 2009.~      Achieving higher knee flexion may be required for cultural reasons or by the increasingly~     younger, more active patient population undergoing knee replacement today. In addition to~     promoting flexion, it is also possible that this design change may help the knee replacement~     to last longer than traditional implants in patients who achieve higher flexion. Therefore,~     the study will compare the two devices in terms of survivorship, flexion and other measures~     of the success of a total knee replacement (range of motion, knee-related quality of life,~     activity and generic quality of life) over the short-term.~      A minimum of one hundred and forty subjects (minimum 70 per group) with osteoarthritis and~     aged 50-75 years will be included at UK/international hospitals.~      Study duration is 2 years and patients will complete standard knee outcome scores plus~     radiological evaluation.~      Subjects would receive one of the study devices regardless of their involvement in the study,~     and apart from (possible)additional visits, x-rays and/or questionnaires, treatment and~     follow-up care will be as per the care they would receive outside of the study.~   "
164062|NCT01418365|"~     Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered~     alone & in combination with MMX® Mesalazine/mesalamine~   "
164063|NCT01418352|"~     The goal of the current trial is to determine efficacy and safety of Once-weekly aripiprazole~     in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.~   "
164064|NCT01418339|"~     The goal of the current trial is to determine efficacy and safety of Once-weekly aripiprazole~     in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.~   "
164065|NCT01418326|"~     Knowledge gap: Does the choice of anaesthetic affect outcome for cancer surgery?~      Aim: To retrospectively examine possible associations (Cox Multiple Regression) between~     survival from breast-, colorectal-, or skin cancer and the choice of hypnotic used during~     surgery, ahead of a prospective randomised controlled trial.~      Hypotheses: One- and five-year survival will be significantly higher after radical breast-,~     colorectal-, or skin cancer surgery in patients given the intravenously administered hypnotic~     propofol than in patients given the inhalational hypnotic sevoflurane.~      Method: To merge two registers, of which one holds demographic- anaesthetic-, and surgical~     data from 6 303 patients operated on at the three mentioned anatomical locations at the~     Central Hospital in Vasteras, Sweden during a twelve year period (1998-2009). Of these~     minimum 4 500 operations would be due to cancer. This register is unique, in that it contains~     both types of anaesthesia. The other register holds survival data (date and cause of death),~     stored at the Regional Oncologic Center in Uppsala.~      The choice of anaesthetic will be validated by controlling each patient's anaesthetic paper~     file, concomitantly with extraction of details from anaesthesia and surgery, such as the~     functional classification of each patient (according to American Association of~     Anesthesiologists), co-morbidity, duration of anaesthesia and surgery, amount of blood loss~     and possible transfusion.~      Current knowledge: Different anaesthetics have opposite effects on the immune system and on~     the DNA. There is a well-established association between the state of the immune system and~     cancer growth, which in turn will influence survival. There is also an association between~     DNA damage and cancer development. Inhalational anaesthetics, e.g. sevoflurane, act~     pro-inflammatory, and they are also proven to be genotoxic. Propofol is anti-inflammatory and~     anti-oxidative, and it is not genotoxic.~      Objective: Strengthen the hypotheses, and get statistics for a proper power calculation in~     advance of a multi-centre, prospective, randomised, controlled trial.~      Impact: General anaesthesia is an indispensable part of radical cancer surgery. Undesired~     effects from anaesthesia on survival has strong relevance for the over all cancer treatment.~   "
164066|NCT01418313|"~     The purpose of this study is to develop and validate novel magnetic resonance imaging (MRI),~     dynamic contrast enhanced (DCE)-MRI and positron emission tomography (PET)/MR techniques for~     the detection and risk stratification of patients with atherosclerosis.~   "
164067|NCT01418300|"~     The purpose of this study is to improve first line Helicobacter pylori eradication rate and~     to compare the sequential versus conventional triple therapy.~   "
164068|NCT01418287|"~     A study to characterize children and adults with influenza like symptoms and to determine~     risk factors for severe disease and death among those with H1N1.~   "
164069|NCT01418274|"~     This single-arm, open-label, non-randomized study will evaluate the effect of~     danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in~     healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and~     escitalopram. The anticipated time of the study is 6 weeks.~   "
169365|NCT01348711|"~     To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination~     in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of~     gestation~   "
164070|NCT01418261|"~     The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized,~     controlled study of the safety and effectiveness of renal denervation in subjects with~     uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity~     Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal~     surface of the renal artery.~   "
164071|NCT01418248|"~     Heart Failure with Preserved Ejection Fraction (HFpEF) and Pulmonary Hypertension (PH) can be~     diagnosed noninvasively by Exercise Echocardiography (ExE) and Cardiopulmonary Exercise~     Testing (CPX) as compared with gold standard invasive hemodynamic assessment.~   "
164072|NCT01418235|"~     Sub-Saharan Africa is the region most affected by the global Human Immunodeficiency Virus~     (HIV) epidemic. A vaccine is the most promising preventive approach against new HIV~     infections. The purpose of this study is to evaluate the safety and immunogenicity of 4~     experimental preventive HIV vaccine regimens in HIV-uninfected adults in South Africa.~   "
164073|NCT01418222|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety~     of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in~     patients with metastatic colorectal cancer.~   "
164074|NCT01418209|"~     The primary objective of this study is to determine the efficacy of both low-dose oral (by~     mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in~     reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR~     to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is~     currently considered the most established but also a controversial therapy. 17-ß-estradiol is~     a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine.~     Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a~     substance containing no medication.~   "
164075|NCT01418196|"~     Metabolites of dietary phosphatidylcholine- choline and trimethylamine N-oxide (TMAO)- were~     recently identified as being associated with myocardial infarction in a case-control study.~     The latter TMAO is a gut-microflora-derived choline metabolite that has been shown to be a~     potent risk factor for cardiovascular disease (CVD). This pilot study seeks to use~     information derived from a dietary questionnaire in children to test the association of~     dietary choline intake to plasma levels of TMAO as well as the relationship between plasma~     choline levels and components of atherogenic dyslipidemia (increased triglycerides and small~     LDL, and reduced HDL cholesterol). An ancillary goal of this study is to build on existing~     programs of community outreach to local Oakland/Berkeley minority communities, and to develop~     an infrastructure for family-based and community participation in clinical research across~     the full age spectrum and among diverse populations. This pilot study will examine the~     association of dietary choline intake assessed by food frequency questionnaires to biomarkers~     of CVD risk in 40 children (> 7 years of age) and their parents as there is no information~     regarding this relationship in children. The results of this pilot study will form the basis~     for a proposal to carry out a randomized intervention trial to directly test the effects of~     dietary choline intake on plasma TMAO and lipoprotein levels. Ultimately, better~     understanding of the relationship between dietary choline intake and CVD risk factors may~     facilitate the formulation of appropriate dietary choline recommendations in children and~     adults.~   "
164076|NCT01418183|"~     This study will assess the efficacy and safety of levobupivacaine for postoperative pain~     control in patients received orthognathic surgery. In this split-mouth study, each side will~     be randomized to receive 1) 5ml 0.5% levobupivacine, 2) 2.5ml 0.5% levobupivacaine, or 3)~     placebo. One shot of these agents will be delivered by nerve block to maxillary and~     mandibular branches of trigeminal nerve before the incision was made. The degree of~     postoperative pain will be evaluated daily by visual analog scale for up to 3 days. The~     anticipated time on study is 1 year, and the target sample size is 40 individuals.~   "
164077|NCT01418170|"~     Specific Aim 1:~      To determine if the effect of cervical spinal manipulation on the pressure pain thresholds in~     a myofascial trigger point in the infraspinatus muscle can be enhanced and/or extended after~     a second cervical spine manipulation is given during a single subject visit.~      H1: There will be a statistically significant increase in pressure pain thresholds in the~     myofascial trigger point in the infraspinatus muscle after the second cervical spine~     manipulation, as compared to the first.~      Specific Aim 2:~      To determine if the effect of two cervical spinal manipulations on pressure pain thresholds~     in a myofascial trigger point in the infraspinatus muscle will be present at 48 hours~     follow-up. Data will be collected for descriptive purposes and hypothesis generation.~   "
164078|NCT01418157|"~     Acute mountain sickness is a common ailment in people venturing over 2500 m altitude.~     Pilgrims to high altitudes are at an added risk since they are unaware and they gain height~     faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of~     acute mountain sickness. There are no randomized controlled trials that have studied~     protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies~     regarding this matter.~      This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus~     placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent~     that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will~     be randomly assigned for 3 days and participants will be assessed at 3 stations.~      This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be~     the first RCT done in this issue.~      The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent~     to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the~     incidence and severity of acute mountain sickness.~   "
164079|NCT01418144|"~     The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane~     (TAP) block as a part of a multimodal postoperative pain management after laparoscopic~     surgery on colon.~   "
164107|NCT01417780|"~     A study to evaluate the safety and pharmacokinetics profile of different doses of AB103~     administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled~     for an urgent surgical intervention as part of their standard of care.~   "
164108|NCT01417767|"~     The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine,~     homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk~     myelodysplastic syndromes(MDS).~   "
164080|NCT01418131|"~     Ulcerative Colitis (UC) is a life-long incurable disease with remissions and exacerbations.~     Inflammation confined to the rectum occurs in a quarter of patients and can be extremely hard~     to treat. Many medications have been tried in order to control the inflammation, but they do~     not always work. One of the newer medications is the immunosuppressing medication, tacrolimus~     that has been shown to be effective in UC when taken orally. Unfortunately, the oral use of~     this medication can have numerous serious side effects. In order to overcome these side~     effects, the use of topical rectal tacrolimus has been examined. Pilot studies in ulcerative~     proctitis (inflammation confined to the rectum) resistant to conventional therapies have~     demonstrated a clinical remission in 75% of patients and although the medication was well~     absorbed through the lining of the bowel, the levels in the blood were very low and no~     serious side effects were reported. The findings suggest that this preparation is indeed~     effective for inflammation in the distal bowel and that the method of administration reduces~     side effects. Further work, however, now needs to be undertaken to validate the original~     findings.~   "
164081|NCT01418118|"~     Following surgery to remove tumours of the head and neck, patients undergo reconstruction~     with free flaps - tissue that is taken from elsewhere in the body and given a new blood~     supply by attaching it to vessels in the neck. Following this type of surgery, patients often~     need medication to maintain their blood pressure in the intensive care unit. The effect of~     these drugs on the transplanted tissues is unknown. This study investigates the effects of~     four commonly used drugs on free flap perfusion.~   "
164082|NCT01418105|"~     The research is about a prospective study conducted in patients suffering from dysphagia and~     cervical spine disorders and how they are interrelated. Three questionnaires have been given~     to patients with neurologic deficits, the first of these investigates the occurence of~     dysphagia in the three stages of swallowing, the second looks into the quality of life~     following a stroke or other neurologic damage and the third analyses how cervical spine~     disorders can affect every day life. After the bedside examination, VFSS or FEES, the~     patients are submitted to swallowing and cervical resistance exercises in fixed time periods~     after their hospitalisation. The results will be collected and evaluated using the~     statistical programme SPSS.~   "
164083|NCT01418092|"~     The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered~     daily to adults with OIC.~   "
164084|NCT01418079|"~     A cerebral oximeter is a device that uses light to measure the amount of oxygen within the~     brain. It is similar to the device that measures the level of oxygen in the tip of the~     finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the~     forehead that both emits and detects the amount of light absorbed. This study will determine~     how accurate the device is by comparing the displayed value on the monitor with blood samples~     taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In~     order to test the device over a suitable range, the level of oxygen within the blood will be~     reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the~     equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy~     volunteers.~   "
164085|NCT01418066|"~     In the present study the investigators are trying to evaluate the effect of Murraya koenigii~     leaves, Punica granatum and Curcuma which is administered to the patients in a combined form~     as tea. This study will help to evaluate the effect of these preparations scientifically in~     improving the IBS symptoms.~   "
164086|NCT01418053|"~     The purpose of this study is to determine whether a daily use of a Kneipp hot cataplasm with~     caraway oil is effective in the treatment of abdominal pain and complaints caused by~     Irritable bowel syndrome.~   "
164087|NCT01418040|"~     This is a single centre prospective observational noninterventional study of men with~     histological confirmed prostate cancer, high risk disease and not positive for metastatic~     disease planned to receive Radiotherapy and 18 months of Androgen Deprivation Therapy (ADT).~     Although ADT improves the chance of cure, it can also have many side effects. One of these is~     bone mineral density loss. When this is advanced, it is called osteoporosis. Men with~     osteoporosis have a higher chance of getting fractures of bones such as the hip and spine.~     Currently, the best way to measure for osteoporosis is to do a bone mineral density scan~     using a DEXA scanner.~      The primary objective of this study is to see if baseline Magnetic Resonance Imager (MRI) and~     a Computer Tomogram (CT) combined with clinical factors predicts which men are at greater~     risk of accelerated ADT induced bone mineral density loss than baseline DEXA scanning alone.~     The data from the patients will be used to construct a model predicting annual rate of bone~     loss based on baseline imaging, clinical and biochemical characteristics.~      Secondary aims for this study are as follows:~        -  Evaluating the feasibility, toxicity (acute and late) and efficacy (5 year biochemical~          control by the Phoenix definition)of multimodality therapy with hypofractionated~          radiotherapy (giving a larger dose of radiotherapy over a shorter time 5½ weeks compared~          with a standard 8 week approach). Although used overseas, this 5½ week regimen has not~          been used widely in Australia, and we would like to see if we gain similar results here~          as have been reported from the US.~        -  Feasibility and efficacy of a risk adapted duration of neoadjuvant hormonal therapy.~          Usually, ADT is given for between 19 months before radiotherapy is started but there is~          no agreement as to which duration is best. This trial aims to tailor the duration of ADT~          prior to radiotherapy based on blood PSA test results.~        -  Prognostic value of circulating tumour cells (CTCs). This is a blood test which can~          detect cancer cells in the blood which has been used for patients with metastatic~          cancer. The presence of CTCs in men with prostate cancer correlated with poorer overall~          survival. Potentially, high risk prostate cancer patients with CTCs detected may~          represent a very high risk group and could therefore warrant treatment intensification.~        -  To correlate bone marrow changes on MRI with changes in blood counts and patient~          reported fatigue. Measuring bone marrow may help in predicting not just which patients~          are at risk of losing bone faster but also of becoming anaemic, and suffering fatigue. A~          correlation may better explain some of the toxicities associated with ADT.~        -  Implementation of a nomogram based radiotherapy target delineation algorithm. This trial~          aims to use a decision making tool called a nomogram to help tailor the area to treat in~          a more standard way.~   "
164088|NCT01418027|"~     The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase~     of physical activity are recommended as an effective approach for the prevention and~     treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In~     the present study we aim to compare the effect of intensive and conventional exercise~     interventions on NAFLD.~   "
164089|NCT01418014|"~     The advances in treatment to prevent maternal HIV transmission to neonates have been~     groundbreaking. As a result, the number of new perinatally-infected children in the U.S. is~     now small. Subsequent improvements in the treatment of HIV-infected infants and children have~     been equally remarkable, ensuring that most previously infected American children have~     survived and are approaching adolescence. In addition, the number of HIV-infected adolescents~     worldwide is growing substantially in both resource-poor countries and in countries with~     increasing levels of health care. Therefore, there is a global cohort of children who have~     been living with HIV infection since birth who are aging into adolescence. Little is~     definitively known about the impact of HIV infection and its treatment on the maturation~     process in these children.~      AMP is a prospective cohort study designed to define the impact of HIV infection and~     antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection.~     Domains to be investigated include growth and sexual maturation, metabolic risk factors for~     cardiovascular disease, cardiac function, bone health, neurologic, neurodevelopment,~     language, hearing and behavioral function, and sexually transmitted infections (STI).~   "
164090|NCT01418001|"~     The purpose of this study is to see the effects, good and/or bad, of the drug combination of~     gemcitabine, docetaxel and pazopanib on sarcoma. This is a phase Ib-phase II clinical trial.~     The goal of a phase Ib part of the clinical trial is to confirm a dose of the drugs that is~     safe. The investigators determine this by closely checking for side effects that the patient~     may experience.~   "
164109|NCT01417754|"~     To investigate if there are detectable changes in volume and circulation in breasts of~     healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus~     nonmedicated cycle.~   "
164110|NCT01417741|"~     The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus~     standard therapy on postoperative nausea and vomiting in pediatric patients undergoing~     tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either~     the treatment or the control group.~        1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the~          induction of anesthesia~        2. Control Group: Standard anti-emetic therapy only~      This study will monitor nausea, retching, and vomiting events both directly after the surgery~     as well as the next day via a follow-up phone call to the parents of the study participant.~   "
164091|NCT01417988|"~     This study investigates the prevention of early mortality in patients initiating~     antiretroviral therapy (ART) in sub-Saharan Africa where 79% of the co-infected cases of TB~     reside. Many published studies have shown a surprisingly high proportion of all patients~     initiated on ART dying within 6 months (8-26%) with increasing risk with decreasing CD4 T~     cell count. The majority (median 70%) occur in the first 3 months with the greatest~     proportion of deaths due to previously undiagnosed tuberculosis (TB). The investigators will~     enroll patients from 4 geographically diverse countries (Gabon, Mozambique, South Africa, and~     Uganda) in a randomized open label clinical trial targeting a population of people with high~     mortality risk; patients with CD4 T cell count < 50 cells/μl and body mass index (BMI) < 18~     kg/m2. Severely immunocompromised patients with low BMI in the intervention arm will receive~     presumptive anti-TB 4-drug chemotherapy and subsequently initiate ART within 2 weeks compared~     to ART alone. The main objective is to measure and compare early mortality in the group~     presumptively treated for TB in addition to ART. Other sub-objectives are to determine the~     predictors of early mortality and the causes of death by autopsy (traditional and verbal), to~     determine if presumptive anti-TB treatment affects viral suppression with ART, and to assess~     incidence rates and characterize drug toxicity in patients dually treated. Because of the~     high rates of TB co-infection in sub-Saharan Africa in the HIV-infected, the investigators~     expect that patients presumptively treated for TB in addition to HIV will have a lower~     mortality rate than patients receiving ART only. This trial is expected to be of great public~     health benefit and generalisability.~   "
164092|NCT01417975|"~     Female and male smokers will complete questionnaires and smoking behavior will be examined.~     After abstaining from smoking for approximately 18 hours, they will be randomized to a~     moderate intensity exercise groups or passive sitting group. Smoking satisfaction and smoking~     behavior will be assessed following treatment.~      The hypotheses detailed below are specific to the randomization of participants into the~     following 2 groups:~        1. Moderate exercise (Experimental condition; MEG)~        2. Passive sitting (Attention control condition; PSG)~      Hypothesis 1: A bout of moderate intensity exercise will be associated with decreased smoking~     satisfaction after a temporary period of abstinence compared to a control condition.~      Hypothesis 2: Smoking topographic measures will mediate the relationship between a bout of~     moderate intensity exercise and smoking satisfaction.~   "
164093|NCT01417962|"~     The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a~     minimally invasive approach for post-mortem assessment of the fetus, infant and child, with~     similar detection rates for anomalies and determination of the cause of death.~      This will be achieved by acquiring a database of whole-body, post-mortem MR images in~     approximately 400 fetuses, infants and children, over a 3 years period. Images will be~     acquired on a dedicated 1.5T research MR scanner. MR images will be reported by an expert~     group of paediatric radiologists, and compared, in a blinded fashion, with reports from~     conventional autopsy performed by expert perinatal and paediatric pathologists. Importantly,~     the post-mortem information will be assessed with reference to the needs of the parents,~     referring clinicians and HM Coroners. The detection of central nervous system abnormalities~     will be assessed separately.~      The study will be performed across two sites: A dedicated children's hospital (Great Ormond~     Street Hospital) and a teaching hospital, with large obstetric, fetal and neonatal~     departments (University College London Hospital), which are linked academically by University~     College London.~      Co-ordination of the project will be managed by a steering committee, which will ensure~     accurate collation and comparison of the data.~   "
164094|NCT01417949|"~     The purpose of this study is to compare the early versus deferred initiation of~     antiretroviral combination therapy consisting of tenofovir, emtricitabine and~     atazanavir/ritonavir in treatment naive patients who present with an acute AIDS-defining~     illness, namely pneumocystis pneumonia (PCP) or toxoplasma gondii encephalitis (TE).~   "
164095|NCT01417936|"~     The trial is designed as a multi-center, open label Phase 2 trial that investigates the~     efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck~     (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor~     receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to~     that therapy. It is believed that Sym004 has the potential to induce tumor responses and~     provide a superior treatment option to subjects with advanced SCCHN.~      Symphogen was the sponsor for planning/conducting and reporting results for this trial.~   "
164096|NCT01417923|"~     Vitamin D3 is produced in the skin following exposure to UVB light from the sun or artificial~     sources, and occurs naturally in a small range of foods.More recently, several reports~     underlined the impact of vitamin D on the prevalence and consequences of inadequate vitamin D~     intake and the research supporting its benefits for alleviating chronic musculoskeletal pain~     and fatigue syndromes in outpatients. Experts have recommended that vitamin D inadequacy~     should be addressed in all patients with bone or joint pain, myalgia, fibromyalgia, or~     chronic fatigue syndrome. It appears that soothing the daily musculoskeletal pain by~     supplementation of vitamin D may be a simple, well tolerated, and cost-effective modality.~      Aim of study:~      To study the potential therapeutic effects of vitamin D supplementation on patients with~     persistent musculo-skeletal pain. Clinicalparameters, visual analog score,short form McGill~     Pain Questionnaire,patient global perceived effect, quality of life assessed by SF-36~     Questionnaire and laboratory parameters, the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF~     and prostaglandin E will be assessed.~   "
164111|NCT01417728|"~     The aim of the study is to analyze the mechanism of action of infliximab at the~     endomicroscopic level and to analyze mucosal healing - i.e. structural and functional changes~     in the mucosa in IBD patients - and associated processes such as permeability and bacterial~     invasion of the mucosa. In this study the role of the above mentioned parameters and further~     the establishment of endomicroscopic scores will serve to define new prognostic markers in~     view of long term remission upon infliximab treatment.~   "
164112|NCT01417715|"~     Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders,~     Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and~     histologic features including patterns of inflammation, crypt abscesses and granulomas.~     Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for~     gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an optical biopsy~     of the gastrointestinal mucosa during the endoscopic procedure.~      The main objective of this study is to determine endomicroscopic features of mucosal healing~     in patients with IBD.~   "
164097|NCT01417910|"~     Over 3000 people each year undergo bypass operations to their lower limbs, and these~     operations carry significant risks with approximately 1 in 20 of these people dying in~     hospital, and another 1 in 20 having a heart attack.~      Assessment of these patients in order to stratify their risk of both dying and having~     significant complications aid in improving their care, enable better utilisation of scarce~     critical care resources, and allow us to give patients better information on which to base~     consent.~      Aims The aims of the project are to assess the feasibility of exercise testing this group of~     patients both with cycle and arm exercise, and to identify markers of outcome in this group.~      Methodology This is a prospective observational study designed to test the hypothesis that a~     combination of cardiopulmonary exercise testing and blood tests provides prognostic value on~     outcome measures after surgery for lower limb revascularisation~      Subjects will have 2 exercise tests, one arm and one cycle, prior to surgery at their~     preoperative assessment appointment. From these tests we will measure how much work patients~     can do, how much oxygen they are able to use, and when the heart is unable to deliver enough~     oxygen to the cells. In addition they will have blood samples taken prior to the operation~     (brain natriuretic peptide), and on days 1 and 3 (troponin I) after the operation to look at~     cardiac markers of damage.~      This data will be used to see if we can predict those patients that have both short and long~     term complications, and also to see whether the different forms of exercise testing are~     comparable, or if one type is superior.~      Expected outcomes We expect that through a combination of exercise testing and blood test we~     will be able to identify patients at increased risk of complications after surgery. We also~     expect to find that arm exercise will be a more feasible and informative test that cycle~     exercise.~   "
164098|NCT01417897|"~     The planned HERMES study is to investigate and compare the effects of Insulin Glulisine,~     Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and~     several clinical and laboratory markers of postprandial endothelial cell function,~     sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary~     parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a~     biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are~     missing, it is not possible to calculate sample size and statistical power. Therefore the~     goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations~     and estimations on the probability of success of HERMES.~   "
164099|NCT01417884|"~     Molecular targets on platelets are pivotal for the development of new pharmacological~     substrates for platelet inhibition and to better understand the impact of platelet-mediated~     inflammatory processes for the progression of heart disease, such as coronary heart disease~     and chronic heart failure. Previous investigations on the thienopyridine Clopidogrel have~     underlined the importance of combined risk factor analysis. Thus, clopidogrel´s prognostic~     efficacy relies on the combination of genetic factors (mainly polymorphisms of CYP2C19~     encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant drugs.~     Therefore, a prospective patient cohort with exact phenotypic characterisation according to~     standardized protocols is necessary to enable the examination of the clinical relevance of~     potential molecular targets. A supplementary provision of high quality bio-material enables~     the systematic examination of new promising platelet-biomarkers in cardiovascular disease,~     which already have produced significant results on experimental animal and/or cell biologic~     models. Primary objective of the central project is to establish a prospective cardiological~     cohort in the setting of a Cardiovascular Clinical Research Unit (CCRU) with an affiliated~     Biobank and thus to review the clinical significance of potential targets deriving from~     individual subprojects within the research group (German Research Council KFO 274/1-1) to~     safeguard a translational approach.~   "
164100|NCT01417871|"~     Aims: We evaluate the efficacy of the Active Body Control (ABC) Program for weight~     reduction in patients with metabolic syndrome.~      Methods: The ABC program combines telemonitoring of the physical activity with a low-calorie~     diet also preferring carbohydrates with low glycemic indexes. In this 12-month, randomized,~     clinical trial 60 patients will be treated according to the ABC program and 60 control~     patients will receive standard therapy.~   "
164101|NCT01417858|"~     The purpose of this study is to compare the intra-ocular (IOP) control efficacy between~     brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI).~   "
164102|NCT01417845|"~     The purpose of this randomized clinical trial is to compare the effect of moderate versus~     high intensity exercise training on physical fitness and physical function in patients with~     type 2 diabetes. The research hypothesis is that high intensity exercise training will be~     superior to moderate intensity on such outcomes in individuals with type 2 diabetes.~   "
164103|NCT01417832|"~     The purpose of this study was to compare with a clinical randomized controlled split-mouth~     design study the changes in the therapeutic effect of infiltrating versus sealing proximal~     caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion~     progression, evaluated by radiographic techniques.~   "
164104|NCT01417819|"~     Rigorous and regular follow-up is essential to successful management of childhood cataract,~     but it is often ignored by parents and especially difficult to be delivered in China, such an~     average-medical-resource-limited country.~      Health programmes that use mobile communication technologies are emerging with the aim of~     strengthening health systems.~      The investigators aimed to assess whether mobile phone short message service (SMS) for~     parents of cataract children involved in the Childhood Cataract Program of Ministry of Health~     of China (CCPMOH) improved follow-up adherence and detection rate of the timing of surgery,~     postoperative complications and necessary replacement of glasses.~   "
164105|NCT01417806|"~     The majority of small cell lung cancer(SCLC)(50-100%) express somatostatin receptors(type~     1-5) with some small cell lung cancer express more than one subtypes. Stimulation of these~     SSTR's lead to inhibition of angiogenesis and cell growth. SOM230 also lower levels of IGF~     which is known to contribute to SCLC proliferation. Topotecan is approved for second line~     therapy in relapsed small cell lung cancer. We hypothesized that combination of both agents~     should yield greater antitumor activity.~   "
164106|NCT01417793|"~     According to WHO database, an average of 540 million people worldwide dies from smoking~     related diseases every year. The use of tobacco products may reduce the average life~     expectancy of about 15 years. The data of 2009 from Department of Health Bureau of Health~     showed 38.57% male adults and 4.75% female adults smoked in Taiwan. Studies about smoking~     rate within prison inmates were between 64-91.8%, which was over 3 times than the general~     population. Smoking cessation can lower the risks of smoking related health problems. Two~     thirds of smokers in Taiwan once tried smoking cessation but the success rate was about 5%~     every year.~      In view of high smoking rate within prison inmates in Taiwan, Agency of Correction, Ministry~     of Justice announced a smoking cessation program for inmates in April 2010. The purpose of~     this study was to investigate the effects of this program and the difference of cessation~     success rate between various interventional methods, using questionnaires for smokers and~     smoking cessation clinics database.~   "
164113|NCT01417702|"~     Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders,~     Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and~     histologic features including patterns of inflammation, crypt abscesses and granulomas.~     i-Scan use an endoscopic image from the video processor and reconstruct virtual images in~     real time, resulting in an improved contrast of the capillary patterns and enhancement of the~     mucosal surface (so called virtual chromoendoscopy).~      The main objective of this study is to determine endoscopic features of mucosal healing in~     patients with IBD and to compare these features to clinical and histological data in order to~     establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing~     as a parameter of remission and relapse.~   "
164114|NCT01417689|"~     Eye drop instillation is a problem from glaucoma patients. Studies reveal that 30-50% of~     glaucoma patients have problems instilling their eyedrops. These problems include not hitting~     the eye, spending many drops to get a single successful instillation and bottle~     contamination.~      The present study will evaluate the effect of encouraging patients to put their eyedrops~     using one of 2 techniques, randomly assigned, to determine which is more successful at~     instilling the eye drop into the eye while spending the least amount of drug.~      In one of the techniques the patient instills the eye drop with their eyes open in the~     inferior cul de sac. In the other technique the patient instills the eye drop with the eyes~     closed near the inner canthal region.~      Patients will be randomized to encouragement to use the drops with either of the techniques.~     Encouragement will take place over a visit where they will be subjected to:~        -  Baseline evaluation of eye drop instillation using their usual technique.~        -  Short (2-5 minute) educational session session for the assigned technique.~        -  Followup evaluation immediately after the educational session.~   "
164115|NCT01417676|"~     This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study.~     The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation~     with simultaneous integrated boost to prostate in high risk prostate cancer patients.~   "
164116|NCT01417663|"~     Healthy but sedentary aging leads to increased morbidity and mortality of cardiovascular~     disease. This is partly due to the accumulation of Advanced Glycation Endproducts (AGEs) and~     the stiffening of the myocardium and arteries. New medication has been developed to break~     these AGE-crosslinks to improve cardiovascular compliance. The positive influence of regular~     physical activity is well known for cardiovascular disease and aging. Therefore, what is the~     most effective intervention, physical exercise and/or new medication AGE-crosslink breakers,~     in improving the cardiovascular and cerebrovascular compliance and improving the endothelial~     function in healthy sedentary elderly.~   "
164117|NCT01417650|"~     Temporomandibular disorder (TMD) is the major cause of nondental pain in orofacial area.~     Laser therapy can be considered as one of the most popular methods of pain relief in TMD~     patients. The special features of laser light such as coherence, monochromaticity, and~     collimation can result in the ability of laser light to modify cellular metabolism, increase~     tissue repair and reduce edema and inflammation. The effectiveness of low level laser therapy~     in reducing the signs and symptoms of temporomandibular joint disorders has been investigated~     in a few studies. But, in most of the previous studies the etiology of TMD has not been~     considered in patient selection. Furthermore, there are some controversies in the results of~     these studies. According to our data, there is no study evaluating the effects of low level~     laser therapy on patients having TMJ osteoarthritis.~      The aim of this study is to evaluate the effectiveness of low level laser therapy in~     improving osteoarthritis of temporomandibular joint and also to evaluate the long term~     effects of laser therapy on the morphology of the joint.~   "
164118|NCT01417637|"~     Temporomandibular disorders (TMDs) are the major cause of non-dental pain in orofacial area.~     Laser therapy can be considered as one of the most recent treatment approaches in the field~     of physiotherapy. The special features of laser light such as coherence, monochromaticity,~     and collimation can result in the ability of laser light to modify cellular metabolism,~     increase tissue repair and reduce edema and inflammation. Several studies demonstrated~     successful results regarding the use of low level lasers in releasing pain of musculoskeletal~     conditions, but there are also contradictory reports in this field, and the clinical~     effectiveness of this treatment modality has been debated in some review articles. A few~     studies evaluated the efficacy of low level laser therapy in the treatment of~     temporomandibular disorders and the associated myofacial pain. There are remarkable~     variations in the methodology of these researches and some reported insufficient data~     regarding the physical properties of the laser used. The aim of this study is to evaluate the~     effectiveness of low level laser therapy in improving the sign and symptoms of patients~     suffering from myofacial pain syndrome.~   "
164119|NCT01417624|"~     Heart failure is a common, costly, disabling and potentially lethal condition. Despite well~     recognised and proven drug therapies, many patients remain breathless on exertion. A special~     pacemaker (cardiac resynchronisation therapy) may help improve symptoms of breathlessness and~     survival by restoring coordinated beating of the heart. However, despite careful planning and~     the knowledge of the most appropriate selection criteria, up to a third of patients do not~     get the desired beneficial effects after the pacemaker has been implanted.~      The implantation of the special pacemaker requires three leads (wires) to be inserted within~     the heart. Currently this is undertaken under X-ray guidance. Some patients may have scarring~     of the heart muscle due to previous heart attacks or their underlying condition. The X-ray~     technique cannot see this and therefore the doctor may implant the lead in such an area of~     scar tissue. Cardiac magnetic resonance imaging (CMR) can demonstrate these areas of scar.~     The study aims to investigate whether CMR can better predict where the wires should be~     placed. The CMR pictures will be taken before the patient has the special pacemaker~     implanted.~   "
164120|NCT01417611|"~     Image-enhanced endoscopy in screening colonoscopy~        1. useful tool for detecting subtle epithelial lesions~        2. useful tool for predicting real-time histology of epithelial lesions. Among~          image-enhancing techniques, i-SCAN is new developed and the practical usefulness of~          i-scan for screening colonoscopy has not been investigated yet.~   "
164141|NCT01417325|"~     The registry study is to obtain the state of the art of the percutaneous coronary~     intervention state treatment for coronary heart disease in Beijing area of P.R.China in a~     real world. The data are collected from 48 hospitals in Beijing area using an uploading~     system through internet.~   "
164121|NCT01417598|"~     Balance control, physical activity and health related quality of life will be assessed before~     and after a 10 to 12 weeks training program as well as 6 and 12 months thereafter in 200~     elderly (>60) with balance problems (100 with osteoporosis, 100 with Parkinson's disease).~     Osteoporosis subjects will be assigned to 3 groups (balance training, balance training and~     Nordic walking, or control group) and Parkinson's subjects to 2 groups (balance training or a~     control group). The training will be progressive and specific incorporating dual task~     exercises (directly related to an increased risk of falling). Clinical and laboratory gait~     and balance measures as well as questionnaires will be used to assess physical function and~     quality of life. An earlier study, investigating this training program in healthy elderly~     with balance problems showed that the training was well-tolerated and effective, with a~     significant increase in balance control, physical function and activity. In this study, we~     expect that an improvement in balance function, physical activity and health related quality~     of life, which will lead to a decreased number of falls, prevent and/or postpone incidence of~     a hazardous fall and thereby reduce the burden on the health care system. Our model for~     functional balance training and outcome methods will expand techniques and tools available to~     physical therapists and health care scientist treating and evaluating patients with loss of~     balance function. Elderly receiving therapy with the goal to improve or recuperate physical~     function and balance will benefit from this project.~   "
164122|NCT01417585|"~     This is a cluster randomized controlled trial in which client-centered rehabilitation of~     activities of daily living (CADL) will be compared to usual rehabilitation of activities of~     daily living (UADL) regarding participation in activities of daily living, independence in~     activities of daily living and life satisfaction during the first year after stroke. In~     addition use of health services, caregiver burden and significant others' life satisfaction~     will be studied. Study design, methods and power analysis are based on our previous pilot~     study. Participating rehabilitation centers in the counties of Stockholm, Uppsala and~     Gavleborg have been randomized to supply CADL or UADL. Patients are included who are: < 3~     months after stroke, dependent in at least two activities of daily living, understand~     instructions and referred to a participating rehabilitation unit. Data are collected at~     baseline, 3, 6 and 12 months. For sufficient power 280 participants will be included. In~     addition qualitative longitudinal studies will be performed in order to describe how CADL is~     integrated.~   "
164123|NCT01417572|"~     The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling~     surgery.~   "
164124|NCT01417546|"~     Background:~      - The experimental drug NHS-IL12 may help the immune system become more active and kill~     cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to~     cause less severe side effects than other anticancer drugs, and may be more effective. More~     research is needed to test NHS-IL12 in people who have solid tumors that have not responded~     to treatment.~      Objectives:~      - To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have~     not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age with solid tumors that have not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a medical history, physical exam, blood and urine~          tests, and imaging studies.~        -  Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the~          hospital for at least one day to be monitored with frequent blood tests.~        -  Participants will have periodic blood samples taken before treatment and during the~          first week after treatment for the first two cycles. They will then have blood samples~          taken before treatment for the rest of the cycles.~   "
164125|NCT01417533|"~     Background:~      - Hereditary inclusion body myopathy (HIBM) is a disease that causes walking difficulties and~     increasing muscle weakness. It usually develops in young adults (between 20 and 30 years of~     age), and affects arm and leg muscles. HIBM is caused by mutations in a gene that may affect~     how the muscles function. Researchers want to learn more about the causes, symptoms, and~     effects of HIBM.~      Objectives:~      - To collect genetic and medical information from people with hereditary inclusion body~     myopathy.~      Eligibility:~      - Individuals between 18 and 80 years of age who have hereditary inclusion body myopathy and~     do not use a wheelchair. - Participants must be willing to stop any current treatment of HIBM~     while enrolled in the study.~      Design:~        -  Participants will be screened with a medical history, physical exam, and neurological~          exam.~        -  At the first visit, participants will have the following tests:~        -  Questionnaires about the impact of HIBM on daily activities, mood, and quality of life~        -  24-hour urine collection~        -  Blood samples~        -  Heart function tests~        -  Muscle strength and endurance tests, including walking~        -  Imaging study of the muscles~        -  Participants will return for followup visits at 6, 12, and 18 months. They may be asked~          to return for a final visit at 24 months. Not all tests will be performed at each visit.~        -  Treatment will not be provided as part of this protocol.~      For more information, visit our website: http://hibmstudy.nhgri.nih.gov/~   "
164126|NCT01417520|"~     Background:~      - Erdheim Chester Disease (ECD) is a very rare disease in which abnormal white blood cells~     start growing and affect the bones, kidneys, skin, and brain. ECD can cause severe lung~     disease, kidney failure, heart disease, and other complications that lead to death. Because~     ECD is a rare disease, found mostly in men over 40 years of age, there is no standard~     treatment for it. More information is needed to find out what genes can cause ECD and how~     best to treat it.~      Objectives:~      - To collect study samples and medical information on people with Erdheim Chester Disease.~      Eligibility:~      - Individuals 2 to 80 year of age who have been diagnosed with Erdheim Chester Disease.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have a study visit to provide samples for study, including blood,~          urine, and skin tissue samples. Participants will also have lung, heart, and muscle~          function tests; imaging studies of the brain, chest, and whole body; a treadmill running~          stress test; an eye exam; and other tests as needed by the study doctors.~        -  Participants will be asked to return for a similar set of tests every 2 years, and to~          remain in contact for possible treatment options....~   "
164127|NCT01417507|"~     This trial studies the natural history of brain function, quality of life, and seizure~     control in patients with brain tumor who have undergone surgery. Learning about brain~     function, quality of life, and seizure control in patients with brain tumor who have~     undergone surgery may help doctors learn more about the disease and find better methods of~     treatment and on-going care.~   "
164128|NCT01417494|"~     RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan~     hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving bevacizumab together with combination chemotherapy may be a better~     way to block tumor growth. It is not yet known whether combination chemotherapy is more~     effective when given together with or without bevacizumab in treating patients with~     colorectal cancer.~      PURPOSE: This randomized phase II trial is studying the side effects of giving bevacizumab~     together with first-line chemotherapy and to see how well it works in treating older patients~     with metastatic colorectal cancer.~   "
164129|NCT01417481|"~     The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5~     g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic fibrosis,~     as compared with placebo. During all of the study children will receive their usual treatment~     for cystic fibrosis.~   "
164130|NCT01417468|"~     The purpose of this study is to determine whether learning styles are effective in the~     treatment of traumatic brain injury (TBI) in an educational environment.~   "
164131|NCT01417455|"~     Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are characterized by chronic~     systemic inflammation and share common pathogenic pathways. In both diseases, cytokines like~     TNF (tumor necrosis factor) and interleukin (IL)-17, known for their pro-inflammatory and~     osteoclastogenic effects, are relevant players, however, while RA is characterized by bone~     erosions, AS favors bone overgrowth. Understanding this paradox may hold the key for a better~     management of both diseases. Our hypothesis is that there are differences in the cellular~     environment and intracellular signaling between AS and RA. To test this hypothesis we will~     evaluate the cytokine milieu, the kinetics of bone cells differentiation and their activity~     in untreated and immunosuppressed RA and AS patients. We will also perform the same~     observations in patients exposed to targeted treatments.~   "
164132|NCT01417442|"~     The purpose of this study is to determine whether BRAF V600E mutation in our patients with~     papillary thyroid cancer has an association with poor prognosis.~   "
164133|NCT01417429|"~     This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female~     smokers will first have two 4-day treatment periods, in which they will be randomized to~     galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day~     washout period. During the first 3-days of each treatment period, smokers will have daily~     clinic visits, where they will receive study medications and any adverse effects from study~     medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period,~     subjects will refrain from smoking for approximately 2.5 days, until the experimental session~     on Day 4. Compliance with non-smoking will be verified by CO levels < 10 ppm. During the~     experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine intravenously~     in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced~     among subjects such that equal number of subjects will receive saline first or nicotine~     first. Following each saline and nicotine treatments, physiological, subjective and cognitive~     measurements will be obtained~   "
164134|NCT01417416|"~     The relevance of BBB and IB permeability changes as a major precipitating cause for cognitive~     and digestive dysfunction in the military stress setting.~   "
164135|NCT01417403|"~     This phase I trial studies the side effects and best dose of hydroxychloroquine in treating~     patients with solid tumors undergoing radiation therapy for bone metastases. Drugs, such as~     hydroxychloroquine, may make tumor cells more sensitive to radiation therapy~   "
164136|NCT01417390|"~     The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus~     concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with~     locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of~     induction chemotherapy using gemcitabine and cisplatin in NPC patients.~   "
164137|NCT01417377|"~     This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of~     Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease~     previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.~   "
164138|NCT01417364|"~     The general hypothesis is that administration of testosterone to healthy, older men for 52~     weeks (1 year) following a cycle of 4 weeks of testosterone administration and 4 weeks~     without testosterone (i.e., monthly cycled regimen) will provide the same gains in muscle~     strength, muscle mass, and bone density as standard of care (SOC), continuous administration~     of testosterone for 52 weeks.~   "
164139|NCT01417351|"~     Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis~     Medical Center are currently conducting a study on the effects of vitamin D supplementation~     during pregnancy on maternal health and immune function. The investigators believe that~     vitamin D supplementation at levels greater than the current recommendation is beneficial for~     maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency~     during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due~     to an imbalance in immune function at the placenta. This randomized, double-blind study is~     designed to test this hypothesis. Pregnant women who participate in the study receive either~     400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The~     investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28~     weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The~     investigators are also collecting data on clinical parameters, such as blood pressure and~     glucose tolerance.~   "
164140|NCT01417338|"~     1. To characterize the demographics and clinical course of the patient population diagnosed~          as having WHO group I pulmonary arterial hypertension and WHO group IV pulmonary~          hypertension due to chronic thromboembolic pulmonary hypertension~        2. To describe real-world outcome of Chinese patients with WHO group I pulmonary arterial~          hypertension and WHO group IV pulmonary hypertension due to chronic thromboembolic~          pulmonary hypertension~        3. To evaluate differences in patient outcomes according to classification subgroup~        4. To identify clinical predictors of long-term survival~        5. To assess the relationship between targeted therapies for pulmonary arterial~          hypertension and patient outcomes~   "
164145|NCT01417273|"~     The aim of this study is the comparison between the effects of supplementation with 25000 IU~     preformed vitamin A (retinyl palmitate) or placebo for first 6 months and 10000 IU/day for~     next 6 months on disease activity and progression in patients with Multiple Sclerosis.~   "
164146|NCT01417260|"~     Oxytocin is a hormone that is released in response to distension of the cervix and uterus~     during labor, and after breast feeding as a result of nipple stimulation. In addition to~     oxytocin facilitating birth and breastfeeding, oxytocin has a number of effects on maternal~     behavior including bonding, social recognition, anxiolysis, sexual arousal.~      The role of oxytocin in pain modulation has recently been highlighted. Intranasal or~     intrathecal (spinal) administration has been found to impact pain modulation. The~     administration of intravenous oxytocin has not provided effective analgesia because oxytocin~     is unable to pass to your brain. The role of breastfeeding on analgesia is poorly~     investigated, which is why we are carrying out this study.~   "
164147|NCT01417247|"~     The purpose of this study is to observe the incident of composite cardiovascular events after~     renal sympathetic modification using THERMOCOOL® catheter in patients with metabolic~     syndrome, and evaluate safety and efficacy of the intervention.~   "
164148|NCT01417234|"~     The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System~     for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose~     will be to compare the prospective patients to retrospectively treated acute trauma wounds to~     further evaluate efficacy and safety.~   "
164149|NCT01417221|"~     The purpose of this study is to observe the incident of composite cardiovascular events after~     renal sympathetic modification using THERMOCOOL® catheter in patients with essential~     hypertension, and evaluate safety and efficacy of the intervention.~   "
164150|NCT01417208|"~     The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound~     therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment~     of lower extremity diabetic, venous and mixed aetiology leg wounds.~   "
164151|NCT01417195|"~     The objective of this study was to compare the fertilization rate between the combination of~     Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered~     subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART).~     Additionally the study assessed subjects' ability to mix and store the combination of Menopur~     and Bravelle and to assess safety of the Menopur and Bravelle combination.~   "
164152|NCT01417182|"~     Prostate cancer is the most common cancer among men in the United States. Through early~     detection and improved local therapies a large number of men will be cured. The clinical~     needs include early detection, accurate initial staging and detection of local recurrence or~     metastases in order to permit application of the most appropriate therapy. Therapeutic~     monitoring and prognostic assessment are equally important. Imaging can play an important and~     crucial role in meeting these clinical needs.~      Positron emission tomography (PET) imaging has gained an important role in the clinical~     management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific~     membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18~     positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging~     studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer~     cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission~     tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic~     properties that will represent an advance in imaging prostate cancer. This initial phase I~     study will determine the biodistribution, pharmacokinetics, and prostate specific tumor~     uptake in patients with metastatic prostate cancer.~   "
164153|NCT01417169|"~     This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic~     stem cell transplantation. Micafungin is administered until confirmation of neutrophil~     engraftment or treatment failure.~   "
164154|NCT01417156|"~     Primary objective of this study is to investigate the long-term tolerability and safety~     profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary~     Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31).~      Secondary objectives are to assess effects on some efficacy criteria during long term~     treatment with BIBF 1120 on top of pirfenidone.~   "
164155|NCT01417143|"~     The purpose of this phase II study of TKI258 (Dovitinib) in adenoid cystic carcinoma is to~     evaluate the efficacy of TKI258 (Dovitinib).~   "
164156|NCT01417130|"~     The Alzheimer's Disease Anti-inflammatory Prevention Trial - Follow-up Study (ADAPT-FS) will~     continue observations of the declared primary outcomes of the Alzheimer's Disease~     Anti-inflammatory Prevention Trial (ADAPT) in the cohort previously established for that~     trial.~   "
164157|NCT01417117|"~     Intracerebral hemorrhage (ICH) occurs when small arteries in the brain rupture due to~     weakening by age, high blood pressure, and/or elevated cholesterol. In addition to artery~     rupture, recent data suggests that patients with ICH are also at risk for developing~     occlusion of arteries during the acute phase, called ischemic strokes. Data suggests these~     ischemic strokes can negatively impact patient outcomes. Diffusion weighted imaging (DWI) is~     a sequence on Magnetic Resonance Imaging (MRI) that is a sensitive marker for ischemic~     strokes in the brain. In this proposal, our primary aim is examine prospectively the effect~     DWI abnormalities have on functional outcomes in patients with ICH. Our hypothesis is that~     the DWI abnormalities found on MRI of the brain lead to worse functional outcomes in patients~     with ICH~   "
164158|NCT01417104|"~     This study is being done to assess the effectiveness of short term (~9 months)~     Aliskiren/Placebo therapy to slow down the progression of atherosclerotic disease in thoracic~     and abdominal aorta. This will be checked by comparing before and after therapy magnetic~     resonance imaging (MRI) pictures of the aortic wall. Aliskiren is an FDA approved drug for~     hypertension but in this study is used for a new indication. Recent studies with animals have~     shown that Aliskiren therapy reduces the atherosclerotic plaque. Therefore, in this study,~     the investigators would like to evaluate whether the investigational drug Aliskiren, which is~     not FDA approved for this indication has the same beneficial effects in people with~     atherosclerotic disease.~   "
164202|NCT01416519|"~     The objective of this study is to assess whether there is a difference between a care~     protocol with the use of incentive spirometry (Voldyne ®) and another with the application of~     NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main~     focus of the study is to determine the incidence of pulmonary complications in each~     technique.~   "
164159|NCT01417091|"~     This is a randomized, open label intra-patient dose escalation study to evaluate safety and~     tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis~     imperfecta (OI).~      Pharmacodynamic effect will be determined by serological biomarkers and radiologic~     assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.~      Twelve to 15 patients will be enrolled.~   "
164160|NCT01417078|"~     The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray~     following a single dose in epileptic patients experiencing a seizure episode.~   "
164161|NCT01417065|"~     The goal of this clinical research trial is to study the effects of the FDA-approved drug,~     temsirolimus, using a new type of clinical study design called a Phase 0. This type of~     study may be able to predict if a drug can affect cancer and may be able to prevent~     potentially useful study drugs from being discarded before they are fully tested.~      The purpose of the study is not to treat the cancer, but to help improve general cancer~     treatment knowledge.~   "
164162|NCT01417052|"~     The primary objective of this study is to determine the safety of LX3305 in a dose escalation~     compared with placebo over 12 weeks in subjects with active rheumatoid arthritis (RA).~   "
164163|NCT01417026|"~     The main objective of this study is to determine the safety and therapeutic potential of~     intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when~     paired with a computer game intervention that is designed to enhance face perception skills.~   "
164164|NCT01417013|"~     The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to~     moderate dry eye subjects.~   "
164165|NCT01417000|"~     Test the safety, immune response and efficacy of GVAX pancreas vaccine (with~     cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone~     in adults who have failed or refused prior treatment for metastatic pancreatic cancer.~   "
164166|NCT01416987|"~     This prospective study will collect safety information from more than 600 patients treated~     with Pergoveris®.~      During the Post-Marketing Surveillance (PMS) period, data about the patient´s background,~     patient's medical history, Pergoveris® indication, prior infertility medication, Pergoveris®~     treatment status, concomitant drugs, all adverse events (regardless of the causal~     relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) will be~     collected for study purposes.~      The post marketing surveillance is based on all cases treated with Pergoveris®.~   "
164167|NCT01416974|"~     The purpose of this Phase I study is to test the safety and effect of specially prepared~     cells collected from the patients called modified T cells. We want to find a safe dose of~     modified T cells for patients who have disease remaining after initial chemotherapy. We also~     want to find out what effects these T cells have on you and your leukemia.~   "
164168|NCT01416961|"~     This study is needed to assess the feasibility of integrating this therapy with current~     treatment regimens. If this study shows success a formal phase II test study to conduct~     feasibility will be the next step. The first dose level chosen for this study is 66Gy of~     radiation to the tumor between LET and standard photon therapy. This dose is the current~     standard of care for stage III . If this dose is found to be feasible then the dose of LET~     will escalate to the total dose of 74Gy.~   "
164169|NCT01416948|"~     This study will evaluate the efficacy of methylphenidate and galantamine in the treatment of~     persistent cognitive symptoms associated with posttraumatic stress disorder (PTSD) and/or~     traumatic brain injury (TBI).~   "
164170|NCT01416935|"~     The purpose of this study is to determine whether anti arrhythmic medication, specifically~     Amiodarone, is required during the first three months post surgical ablation.~      Hypothesis: Amiodarone will not be required during the first three months as verified by no~     increase in rehospitalizations for recurrent Atrial Fibrillation, and report of sinus rhythm~     at surgical follow up (approximately 3 weeks from date of surgery), 6 weeks and 12 weeks to~     include patients' first follow up with cardiologist at approximately 3 months post surgery.~   "
164171|NCT01416922|"~     The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the~     management of women who have received an LSIL Pap report to determine whether the test can~     predict which women will progress to more serious cervical disease and which women do not~     have to be monitored as closely.~   "
164172|NCT01416909|"~     The purpose of this research is to evaluate the effectiveness of the Constipation Treatment~     Protocol and to test whether management according to dose of constipation-inducing~     medications or according to on-going assessment is most effective.~   "
164173|NCT01416896|"~     Our preliminary studies have demonstrated that an innovative new design of the hemodialysis~     venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the~     patient) with three jets is superior to the standard venous needle because it decreases the~     velocity and turbulence of the blood when compared with the standard venous needle, it is~     more efficient in the removal of toxins from the blood, and it is safe and effective. More~     importantly, our preliminary studies suggested that the new needle causes less damage to the~     dialysis vascular access and to circulating blood cells and less inflammation and oxidative~     stress. These will decrease medical complications, the high cost of care and death in~     dialysis patients. The current study will corroborate the finding of previous studies.~   "
164174|NCT01416883|"~     The purpose of this study is to investigate the presence or absence of oral mucosal~     absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects~   "
164175|NCT01416870|"~     The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation~     with Casodex commercial tablet (80mg) in Japanese healthy male subjects~   "
164176|NCT01416857|"~     Aim 1: To develop and validate an Emergency Department(ED) Rasch Disability Diagnostic Tool~     (RDDT).~      Hypothesis:~        -  Rasch modeling will provide an instrument with better measurement properties, including~          increased reliability and validity compared to currently available ED measure of~          disability (MOD).~      Aim 2: To conduct a randomized controlled trial to evaluate the utility of the ED-RDDT to~     reduce rehospitalizations in Medicare recipients visiting an urban Emergency Department for~     non-traumatic illness~      Hypotheses:~        -  Compared to the standard screening tool, the ED RDDT will reduce reutilization of the~          hospital (ED visits, hospital admissions, or death) within 60 days of discharge.~        -  The ED RDDT will reduce costs to Medicare, hospitals and patients.~   "
164177|NCT01416844|"~     In this study, anti-OX40 will be given to patients with melanoma to find out how the immune~     system responds to treatment with anti-OX40. It is hoped that this treatment will cause an~     immune response against melanoma resulting in tumor regression, but this is not known at this~     time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses~     and cancer cells.~   "
164178|NCT01416831|"~     The purpose of this study is compare the response rates in patients with metastatic melanoma~     treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation~     therapy.~   "
164179|NCT01416818|"~     The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-Xiaoyao~     Pill (Herb extracts)on depression, compared to placebo and Bupleurum+Ginkgo in patients~     with Parkinson's disease.~   "
164180|NCT01416805|"~     This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT)~     program for children with anxiety disorders in community health centers. The first phase of~     the study will offer insight into the feasibility of providing this intervention in community~     health centers, while the second phase will compare CCBT to treatment as usual.~   "
164181|NCT01416792|"~     Traditional cardiac surgery requires patient connection to the Cardiopulmonary Bypass (CPB)~     apparatus which takes over the function of the heart and lungs while the surgeon performs the~     necessary surgery. The residual blood left in the CPB equipment (1.5-2.0 L) is centrifuged~     and washed leaving only red blood cells (RBCs) suspended in a saline solution. The RBCs are~     reinfused into the patient as needed by the anesthesiologist. The main problem with this~     technique is that many of the important components of the blood such as plasma proteins and~     clotting factors are discarded through cell washing. This study will explore a novel method~     (multiple-pass hemofiltration) of processing the residual pump blood which will allow the~     patient to receive their own whole blood with minimum waste of important components. The~     newer method of processing the residual pump volume has also been termed off-line modified~     ultrafiltration (off-line MUF) and is similar to the process that the kidneys use to filter~     the blood. It is hypothesized that multiple-pass hemofiltration of the residual CPB volume~     will reduce the occurrence of inflammatory responses, preserve plasma proteins, and decrease~     allogenic blood exposure and improve clinical outcomes as compared to centrifugation.~   "
164182|NCT01416779|"~     The overall purpose of this study is to develop and pilot-test a theory-based psychosocial~     supportive finding balance intervention for older, bereaved spousal caregivers of a~     palliative cancer patient.~   "
164183|NCT01416766|"~     This project will develop and test a low-cost approach to using health information technology~     and home monitoring aimed at improving care for chronic conditions, with low barriers to~     adoption in a wide variety of settings - from large group practices using state-of-the-art~     electronic health records to small practices with no more than a computer with internet~     access. Success will lead to a cost-effective approach to improving control of hypertension,~     both among individuals with diabetes and among non-diabetics, which can make a substantial~     contribution to the health of the population of the United States as improving hypertension~     control is estimated to have a greater population health benefit than most other health~     interventions. Success will also set the stage for adaptation of this intervention to a~     variety of other chronic health conditions and further substantial improvements in the health~     of millions of Americans.~   "
164184|NCT01416753|"~     Background: Data generated with the body composition monitor (BCM, Fresenius) show based on~     bioimpedance technology, that chronic fluid overload in hemodialysis patients is associated~     with poor survival. However, removing excess fluid by lowering dry weight can be accompanied~     by intradialytic and postdialytic complications. Here, we aim at testing the hypothesis that,~     in comparison to conventional hemodialysis, blood-volume monitored regulation of~     ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and~     temperature (UTR) will decrease complications when ultrafiltration volumes are systematically~     increased in fluid overloaded hemodialysis patients.~      Methods/Design: BCM-measurements yield results on fluid overload (in liters), relative to~     extracellular water (ECW). In this prospective, multicenter, triple-arm, parallel group,~     cross-over, randomized, controlled clinical trial, we use BCM-measurements, routinely~     introduced in our 3 maintenance hemodialysis centers shortly prior to the start of the study,~     to recruit 60 hemodialysis patients with fluid overload (defined as ≥15% ECW). Patients are~     randomized 1:1:1 into UCR, UTR and conventional hemodialysis groups. BCM-determined, 'final'~     dry weight is set as -7% ECW postdialysis, and reached by reducing the previous dry weight,~     in steps of 0.1 kg per 10 kg body weight, during 12 hemodialysis sessions (one study phase).~     In case of intradialytic complications, dry weight reduction is decreased, according to a~     pre-specified algorithm. A comparison of intra- and postdialytic complications among study~     groups constitutes the primary endpoint. In addition, we will assess relative weight~     reduction, changes in residual renal function, quality of life measures, and predialysis~     levels of various laboratory parameters including C-reactive protein, troponin T, and~     N-terminal pro-B-type natriuretic peptide, before and after the first study phase (secondary~     outcome parameters).~      Discussion: Patients are not requested to revert to their initial degree of fluid overload~     after each study phase, Therefore, the cross-over design of the present study merely serves~     the purpose of secondary end-point evaluation, for example to determine patient choice of~     treatment modality. Previous studies on blood volume monitoring have yielded inconsistent~     results. Since we include only patients with BCM-determined fluid overload, we expect a~     benefit for all study participants, due to strict fluid management which decreases the~     mortality risk of hemodialysis patients.~   "
164185|NCT01416740|"~     This study will prospectively compare the findings of two diagnostic tests, Direct Magnetic~     Resonance Arthrography(MRA) and Indirect MRA, to the findings during shoulder arthroscopy in~     patients with shoulder pain. The sensitivity and specificity of both Direct and Indirect~     MRA's in diagnosing specific pathologies of the shoulder will be determined using shoulder~     arthroscopy as the gold standard.~   "
164186|NCT01416727|"~     The purpose of this study is to evaluate and compare the effectiveness of two forms of~     clinical skills training for teaching emergency psychiatry skills to doctors who have just~     started to work in psychiatry~   "
164203|NCT01416506|"~     Prospective, non-interventional, multi-center study. 7 investigative centers will involved in~     China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae~     isolates collected.~   "
164204|NCT01416493|"~     This is a proof of concept study asking if alkaline phosphatase injections can reduce acute~     inflammation in rheumatoid arthritis patients.~   "
164205|NCT01416480|"~     The aim of this clinical trial is to evaluate the antitussive effect of Theobromine capsule~     300mg in patients with acute bronchitis.~   "
164303|NCT01415206|"~     This study is a randomized, controlled, multiple risk intervention pilot study evaluated with~     clients recruited from VA Medical Center Substance Abuse Programs. The intervention combines~     an innovative online system with interpersonal MI-based coaching delivered in 4 sessions over~     12-months time.~   "
193731|NCT01027728|"~     The purpose of this study is to evaluate the safety and tolerability of multiple oral doses~     of CCX354-C at a number of dose levels in subjects with stable rheumatoid arthritis (RA).~   "
164187|NCT01416714|"~     The purpose of this study is to collect and store normal and malignant tissue from patients~     with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary~     cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an~     estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with~     gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary~     cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create~     a database for the collected tissue and allow access to relevant clinical information for~     current and future protocols. To create tissue microarrays for each gastrointestinal cancer~     subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular~     cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal~     cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia,~     and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue~     samples (normal and malignant) and relevant clinical information for the investigation of~     tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs,~     paxillin, focal adhesion proteins, cell motility/migration proteins,~     tyrosine/serine/threonine kinase family members, related molecules, and downstream targets~     implicated in the pathogenesis of GI cancers. Examples of molecular testing include~     evaluation of DNA mutation, alternative splice variants, protein expression and~     phosphorylation, and immunohistochemistry on samples. These studies will be correlated with~     clinical information as stated above.~   "
164188|NCT01416701|"~     The purpose of this study is to examine the effect of vitamin D intervention in patients with~     chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.~   "
164189|NCT01416688|"~     RATIONALE: Questionnaires that patients can use to assess skin toxicities related to~     treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab,~     or erlotinib hydrochloride.~      PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in~     patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib~     hydrochloride.~   "
164190|NCT01416675|"~     Objective: Studies documenting the prevalence of delirium among critically ill children are~     still rare. Emerging literature from psychiatric specialists reports the prevalence of~     delirium to be approximately 10% in the pediatric intensive care unit (PICU). This is likely~     to be an underestimation of the true prevalence, as demonstrated in early adult delirium~     literature, especially given the absence of validated bedside tools to diagnose delirium in~     the PICU.~      The primary aim of this study is to validate the German version of the Pediatric Confusion~     Assessment Method for the Intensive Care Unit (pCAM-ICU). The secondary aim of the study is~     to compare validity and reliability of the pCAM-ICU and the Pediatric Anesthesia Emergence~     Delirium (PAED) Scale.~   "
164191|NCT01416662|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with~     pancreatic cancer that has been removed by surgery.~   "
164192|NCT01416649|"~     This study investigates the effect of exenatide, a FDA approved medication for the treatment~     of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be~     studied before and during treatment with Exenatide.~      Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient~     visits over the course of 3-4 months.~   "
164193|NCT01416636|"~     The primary purpose of this study it to determine the effect on 6 minute walking test (MWT)~     distance after 24 weeks treatment with subcutaneous (SC) Treprostinil Sodium in patients with~     Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension.~   "
164194|NCT01416623|"~     Henatinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and~     antiangiogenic activities. This study is designed to evaluate the safety and tolerability of~     Henatinib in patients with Advanced Solid Malignancies~   "
164195|NCT01416610|"~     This prospective, multi-center, observational study will evaluate the efficacy and safety of~     Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously~     untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance~     therapy. Data will be collected from eligible participants receiving Pegasys and Copegus~     treatment as prescribed by treating physician and treatment-free follow-up period of 24~     weeks.~   "
164196|NCT01416597|"~     The purpose of this study is to consolidate the cross-protection offered by influenza~     vaccines against circulating influenza A or B viruses that are not antigenically well-matched~     to vaccine strains and to determine the degree of cross-protection separately for influenza A~     and influenza B, through a systematic review of the literature.~   "
164197|NCT01416584|"~     The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in~     promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment~     injection heroine users.~   "
164198|NCT01416571|"~     This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A,~     prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when~     administered up to 5 years following production.~   "
164199|NCT01416558|"~     Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less~     toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer after~     failure of anthracyclines. However, most patients receive anthracyclines as well as taxanes~     as part of their (neo-)adjuvant therapy. There is currently no standard treatment for~     patients with an early relapse (<12 months) after a taxane containing (neo-)adjuvant therapy.~     Nab-paclitaxel, a novel nano-particle encapsulated paclitaxel is expected to have only~     limited cross-resistant to solvent-based taxanes and might therefore be indicated in this~     setting.~   "
164200|NCT01416545|"~     This study aims to evaluate if a multidisciplinary educational program in primary~     cardiovascular prevention for children could improve the Framingham Score index of their~     parents after one year.~   "
164201|NCT01416532|"~     To evaluate the prognostic value of coronary CT angiography (CCTA) for risk stratification in~     asymptomatic adults in comparison with conventional risk stratification (CRS) and coronary~     artery calcium scoring (CACS).~   "
164206|NCT01416467|"~     The late infantile form of galactosialidosis is potentially amenable to treatment by gene~     transfer with an adeno-associated viral vector encoding Protective Protein Cathepsin A (PPCA)~     or by infusion of purified protein. The published literature contains limited descriptions of~     the disease nor is it known how many patients with the disorder are potentially available for~     protocol enrollment. This preliminary study is designed to define the demographics and~     clinical characteristics of the patient population with galactosialidosis. Individuals for~     whom DNA diagnosis has been performed at St. Jude Children's Research Hospital (SJCRH) will~     be contacted telephonically to learn their current status. In addition, a letter requesting~     information regarding patients with galactosialidosis will be sent to all pediatric~     geneticists throughout the United States. Selected physicians with expertise in lysosomal~     storage diseases throughout the world will also be contacted. Foundations and Associations~     for the lysosomal storage disorders will also be contacted in an effort to identify~     additional potential patients with galactosialidosis. The information to be collected in this~     preliminary study will facilitate development of specific eligibility criteria for future~     therapeutic studies.~   "
164207|NCT01416454|"~     The purpose of the study is to assess potential age-related differences on coagulation~     profile of patients undergoing Cesarean Section, using thromboelastography (TEG). The~     investigators will compare coagulation data collected from the study to assess potential~     differences in coagulation parameters for the following age groups: (i) women less than 35~     yrs (ii) women 35 yrs or older.~   "
164208|NCT01416441|"~     The goal of the current trial is to obtain long term efficacy, safety and tolerability data~     of Once weekly aripiprazole in children and adolescents with Tourette's Disorder.~   "
164209|NCT01416428|"~     The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and~     safety of oprozomib in patients with hematologic malignancies.~   "
164210|NCT01416415|"~     The purpose of this study is to assess whether an educational intervention will have a~     positive effect on patients' ability to properly administer eye drops. The investigators~     predict that the educational intervention will have a positive impact on the efficacy,~     safety, and efficiency with which patients administer their eye drops.~   "
164211|NCT01416402|"~     The purpose of this study is to determine whether arhalofenate is safe and effective when~     dosed in combination with febuxostat in lowering serum uric acid in patients with gout.~   "
164212|NCT01416389|"~     The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to~     ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change~     in tumor size as a continuous measure of response.~   "
164213|NCT01416376|"~     SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic~     inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The~     objective of this study is to determine the effect of a single administration of SRT2379, at~     multiple-dose levels, on the inflammatory response to low dose endotoxin.~   "
164214|NCT01416363|"~     This study will investigate how 3 types of drug formulations are absorbed by the body. This~     study is termed 'open-label', which means volunteers will be aware of which treatment they~     are receiving. The study is split into 2 parts. Part 1, involves volunteers receiving 2 new~     formulations, as a single dose. There is no placebo (dummy-drug; no active ingredient) in~     this study. Volunteers will also receive a single dose of a formulation used in previous~     trials (reference formulation), so a proper comparison with the new formulations can be made.~     The new fomulations will be administered with food and the reference formulation will be~     given without food. In Part 2, volunteers will receive only one of the 3 formulations as a~     repeat dose for 7 days. Each of these doses will be given with food.~   "
164215|NCT01416350|"~     This is a two part protocol (Parts A and B) in healthy volunteers evaluating the~     pharmacokinetics/ pharmacodynamics (PK/PD) of azithromycin to investigate the usefulness of~     various biomarkers (e.g., Interleukin-10 (IL-10), Granulocyte macrophage colony-stimulating~     factor (GM-CSF), mature dendritic cell (MDC), with and without ex vivo lipopolysaccharide~     (LPS) stimulation) as markers of macrolide anti-inflammatory activity.~      Part A is a randomized, open-label parallel group study evaluating PK/PD of a single~     azithromycin dose of 250 or 1000 mg. Data from Part A will be used to assess the dose~     resulting in induction/inhibition of various ex vivo biomarkers relative to a 250 mg dose of~     azithromycin (the clinical dose used in treatment of neutrophil-induced inflammatory~     conditions). This information will guide the range of doses to be studied in a first time in~     humans (FTIH) study of a new chemical entity.~      Part B is a repeat dose study treating subjects with Azithromycin (250 mg every other day for~     3 weeks), the dose approximates that used in the treatment of chronic neutrophil related~     inflammatory conditions. This information will provide insight into whether the biomarker~     effects change over time on repeat dosing and any potential differences observed between~     single and repeat doses.~   "
164216|NCT01416337|"~     A Phase I, single-center, open-label, single-persiod, combined single dose oral and IV~     microtracer study in subjects with solid tumors.~   "
164217|NCT01416324|"~     The purpose of this study is to look at the safety and tolerability of increasing single~     doses of GSK2330672 in healthy volunteers.~   "
164218|NCT01416311|"~     To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects~     receiving the drug until data from a specified number of subjects are accumulated to identify~     factors considered to influence its safety and efficacy.~      <Priority investigation item> Thromboembolism~   "
164227|NCT01416194|"~     This observational cohort study is being conducted to further characterize selected adverse~     events of interest among a patient population with osteoporosis who are prescribed~     bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized~     clinical trial setting. The study will compare the rates of the selected clinical events~     among the three treatment groups.~   "
164301|NCT01415232|"~     The purpose of this study is to determine the correlation between actual epidural needle~     depth (ND) and the use of ultrasound with an epidural depth equation (EQ-US) to estimate~     epidural depth (Est-D) in morbidly obese parturients. It is well documented that in women~     with a BMI greater than 40 kg/m2 successful epidural placement is more difficult. To the best~     of our knowledge the use of an epidural depth equation, which was developed in an earlier~     study using height and weight, with ultrasound visualization will improve identification of~     the epidural space.~   "
164219|NCT01416298|"~     Acute Kidney Injury (AKI) is a common clinical problem defined by an abrupt (< 48 hour)~     increase in serum creatinine (SCr) resulting from an injury or insult that causes a~     functional or structural change in the kidney. Despite significant advancements in the care~     of the critically ill child, mortality rates observed in critically ill children who develop~     AKI have not improved. The investigators have shown even small increases in SCr, which is~     the standard kidney function marker, are associated with increased child mortality, even when~     outcome was controlled for significant patient co-morbidity. Furthermore, the investigators~     have also shown that the amount of fluid accumulation observed in critically ill children~     with AKI is independently associated with mortality suggesting that earlier dialysis may~     improve survival. However, the investigators also do not want to dialyze patients who don't~     ultimately need dialysis, as it is an invasive procedure. The data cited above highlight the~     need not only to detect AKI early, but also predict it severity in order to optimize clinical~     decision making with respect to fluid administration and dialysis initiation. While~     substantial research has been expended to validate NGAL as an early marker of AKI, it has not~     been studied in the context of clinical decision support to guide a therapeutic intervention.~     The investigators hypothesize that NGAL levels can be used to determine predict which~     critically ill children will develop severe and prolonged AKI with substantial volume~     overload, thereby providing the clinician with a diagnostic tool to guide CRRT initiation.~   "
164220|NCT01416285|"~     Congestive heart failure (CHF) is a major public health problem worldwide. CHF carries a~     devastating prognosis, which resembles that of some types of malignant cancer. Despite~     substantial improvements in the management of the disease, the prognosis remains poor~     especially in advanced stages of the disease. For these patients, self-management plan~     includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and~     knowing what to do if signs of deterioration appear, and when to report the changes to~     health. The investigators hypothesize that patients in the heart failure management programs~     that promote self-management by means of intensive education, edema index-assistance, and~     telephone follow-up can improve their functional status and quality of life, as well as the~     biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.~   "
164221|NCT01416272|"~     The objective of this twelve month dispensing study is to evaluate the clinical performance,~     particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.~   "
164222|NCT01416259|"~     This Phase I study will be performed in a double-blind, randomized, crossover design in~     healthy male and female subjects. The central ECG laboratory will be blinded to treatment.~     Every effort will be made to enroll equal numbers of males and females into the study.~      Eligible subjects will participate in a screening phase (within 28 days of the dosing day), a~     treatment phase and a final visit, which will be conducted on discharge from the study. Study~     duration will be 32 days with a total of approximately 12 days of confinement. During the~     resting ECG periods, 12-lead digital ECGs will be extracted from continuous telemetry at~     selected time points to assess potential ECG effects. Blood samples for PK evaluation will be~     collected in conjunction with the ECG time points.~   "
164223|NCT01416246|"~     Multiple myeloma is difficult to treat with only anti-cancer medicine (called chemotherapy)~     or radiation alone. Sometimes higher doses of chemotherapy are used but when used can also~     lower blood counts. Using own cells (special cells called stem cells) to help increase the~     blood counts after high doses of chemotherapy is called autologous stem cell transplantation~     (ASCT).~      Using own stem cells to restore blood counts and other advances in supportive measures~     (antibiotics and growth factors that increase blood counts) has improved the safety of ASCT.~     However, blood counts still decrease for a period of days after high doses of chemotherapy.~     During that time, patients are at greater risk for infections. Studies have shown that the~     faster the blood counts recover after ASCT, the less at risk there is for developing unwanted~     side effects after ASCT.~      Typically during an ASCT, a patient's stem cells are given back to them all at once on a~     single day. In this study, the investigators plan to see what happens when smaller amounts of~     own stem cells are given back to the patient over multiple days. The investigators want to~     find out what effects good and/or bad this will have on the patient and there multiple~     myeloma. Some studies have shown that giving back stem cells over a period of days helps to~     increase bone marrow activity and decrease the time it takes for blood counts to recover~     after ASCT. It is our hope that this new approach may lower a patient's risk of side effects~     and infections, decrease the number of blood transfusions that a patient needs during this~     process, reduce the time a patient has to spend in the hospital, and lower overall treatment~     costs.~   "
164224|NCT01416233|"~     After enucleation or evisceration with placement of a dermis fat graft or integrated orbital~     implant as a primary procedure, there can be secondary loss of orbital fat volume causing~     regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques~     for correction require open surgery to place a sheet/block of biocompatible material or a~     macroaggregate of fat into the orbit to augment orbital volume for permanent correction.~     Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but~     these have proved to be temporary. The current study seeks to show that a permanent~     augmentation of orbital volume can be achieved using a closed cannula injection of autologous~     fat.~   "
164225|NCT01416220|"~     This study is being done to look at how well people respond to two different drug treatments~     for depression. Clinically, people can respond differently to different treatments for~     reasons which are not always clear. Some research shows that people with a family history of~     bipolar disorder or completed suicide may react differently to standard medications used to~     treat depression than those without a family history. The investigators need to know if these~     drugs are effective to use in patients with depression who have a family history of bipolar~     disorder or completed suicide.~   "
164226|NCT01416207|"~     Rationale for the Study:~      The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic~     (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be~     used to support registration of Avonex in China.~      Study Design:~      This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly~     injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood~     samples will be collected with the first and fourth injections of Avonex, and a sparse blood~     sample will be collected with the second and third injections of Avonex.~   "
164228|NCT01416181|"~     This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of~     the placebo-controlled period (Part 1), participants will have the option of enrolling in a~     2-year open-label extension (Part 2).~      Part 1: The primary objective of the study is to investigate whether treatment with~     natalizumab slows the accumulation of disability not related to relapses in participants with~     secondary progressive multiple sclerosis (SPMS).~      The secondary objectives of Part 1 of this study are to determine the proportion of~     participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in~     participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12),~     the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab~     on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical~     (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24~     using magnetic resonance imaging (MRI) and the proportion of participants experiencing~     progression of disability as measured by individual physical Expanded Disability Status Scale~     (EDSS) system scores.~      Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of~     natalizumab in participants with SPMS.~      The secondary objectives of Part 2 of the study are to investigate long-term disability~     (based on clinical or participant-reported assessments) in participants with SPMS receiving~     natalizumab treatment for approximately 4 years and to assess change in brain volume and T2~     lesion volume.~   "
164229|NCT01416168|"~     Surgery for colorectal cancer is a major surgery. People above the age of 60 tend to have a~     higher risk of complications. Some studies indicate that senior cancer patients might benefit~     from a home support after surgery by a geriatric nurse practitioner and a team, beside their~     usual post-operative care. The investigators team is planning a large study to assess whether~     this approach could help patients with colorectal cancer recover better from their surgery,~     get better cancer treatment after that (e.g. chemotherapy), and possibly live longer. This~     study you are asked to take part in is a pilot for this large study.~   "
164230|NCT01416155|"~     The primary objective of the study is to further evaluate the long-term safety and~     tolerability profiles of BG00002 (natalizumab) in Japanese participants with~     relapsing-remitting multiple sclerosis (RRMS). The secondary objective of this study is to~     further evaluate the long-term efficacy profile of BG00002 in Japanese participants with~     RRMS.~   "
164231|NCT01416142|"~     The objective of this study is to evaluate the product performance of PureVision2 HD contact~     lenses.~   "
164232|NCT01416129|"~     The investigators are comparing a new type of prosthetic socket for above knee amputees to~     the standard of care. The hypothesis is that the new type of socket will show equivalence to~     the standard of care using our designated outcome measures.~   "
164233|NCT01416116|"~     The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is~     applied prior to the application of QUTENZA. This is a multi-center, randomized,~     assessor-blinded study which will investigate the use of an oral analgesic as an alternative~     form of pre-treatment for QUTENZA.~   "
164234|NCT01416103|"~     The purpose of the study is to determine whether welfare-to-work schemes combined with~     alcohol treatment are more efficient than a welfare-to-work scheme alone, for unemployed~     citizens with alcohol problems.~   "
164235|NCT01416090|"~     Syndactyly is a relatively common congenital abnormality of the hand occurring approximately~     1 out of 2500 live births (1). It can be simple, meaning only skin and soft tissues are~     shared, or complex, meaning the bone or nail parts are shared. In any case, it is a fact that~     there is not enough skin surrounding the two finger segment to be utilized to cover two~     separate fingers. This can also be proven by simple geometry. Therefore, it has always been~     taught to residents and explained to numerous patients' families that addition of skin graft~     is required for a proper syndactyly release. Without it, skin flaps would be too tight,~     causing some necrosis and significant scarring along the finger and particularly in the web~     space, causing an unsatisfactory functional and cosmetic result requiring revision.~   "
164236|NCT01416077|"~     Surgery for cancer of the esophagus is associated with a high risk of postoperative~     complications. It has been shown that the risk of postoperative complications can be~     decreased by optimising the amount and type of infusion fluids given during surgery, steered~     by measurement of cardiac stroke volume, mostly done with a device called esophageal Doppler.~     This device can however not be used during this type of surgery. This study wants to test the~     hypothesis that postoperative complications in patients operated for esophageal cancer can be~     partially prevented by using a goal directed strategy for the administration of fluids and~     drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave~     analysis (FloTrac).~   "
164237|NCT01416064|"~     Open-label, extension study for subjects that completed 810P202 to examine long term safety~     and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with~     Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
164238|NCT01416051|"~     Today's obesogenic environment, favors behavioral choices that lead to an excess of energy~     intake over expenditure, and consequently weight gain. Intervention strategies that harness~     the body's own appetite and satiety regulating signals could provide an effective means of~     countering excessive energy intake. The purpose of this study was to investigate whether a~     vegetable oil emulsion (Olibra) would result in weight loss that was associated with a~     reduction in food intake.~   "
164249|NCT01415908|"~     This investigation will provide safety and effectiveness information on the use of INFUSE®~     Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a~     Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels~     from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine.~   "
164250|NCT01415895|"~     ATNC05 is a combination of two known marketed generic compounds. The investigators~     hypothesize that the combination acts synergistically to reduce chronic radicular neuropathic~     back pain of the cervical, thoracic and the lumbar regions.~   "
164251|NCT01415882|"~     This randomized phase II trial studies how well ixazomib (ixazomib citrate) works in treating~     patients with multiple myeloma that has returned after a period of improvement but is not~     resistant to bortezomib. Ixazomib citrate may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~   "
164239|NCT01416038|"~     Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to~     destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2,~     and even phase 3 trials. Much has been learned about the principles of applying immune-based~     therapies and specifically the types of patients that may be most likely to mount an~     effective immune response. When used alone, cancer vaccines may have their greatest impact~     earlier in the disease course or in situations with minimal residual disease.~      ImmunoVaccine Technologies Inc. (Immunovaccine) is an immuno-oncology company developing a~     novel adjuvanting technology platform termed DepoVax. DepoVax was created to enhance the~     speed, strength and duration of an immune response. The peptide antigens included in~     DPX-Survivac are designed to target Survivin, a protein which is over-expressed in many~     cancer types, including epithelial ovarian cancers.~      This study was designed be a phase 1-2 trial to determine the safety and immunogenicity~     profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose~     oral cyclophosphamide. The dosing-finding phase 1 study of 15 subjects would move directly~     into a randomized phase 2 study. However, with the evolving field of immunotherapy~     Immunovaccine has begun to focus on combination therapies, combining DPX-Survivac treatment~     with checkpoint inhibitors and other immune modulators, such as in NCT02785250.~   "
164240|NCT01416025|"~     This is a prospective, multicenter, randomized trial to study therapeutic drug monitoring~     (TDM) of voriconazole among patients with an invasive mould infection (IMI). The primary~     objective of this study will be to assess the effect of prospective voriconazole TDM on the~     composite of adverse events (AE) and clinical response.~   "
164241|NCT01416012|"~     Interactive games (virtual reality) have recently been the center of interest and scientific~     discussion in the field of cognitive and functional rehabilitation. From their entertaining~     and contextual aspects, off-the-shelf video games are potentially interesting tools as~     adjunct to the patient care, especially for maintaining instrumental activities of daily~     living (IADL) autonomy.~      Disease and physical inactivity worsen the patient's ability in the IADLs, thus reducing~     health related quality of life (HRQL). This decrease in cognitive and functional abilities~     can be slowed down using adapted rehabilitation program.~      However, there is no randomized controlled study comparing usual physical therapy to virtual~     reality gaming consoles such as the Nintendo Wii or the Xbox 360 Kinect.~      Off-the-shelf gaming consoles offer a large range of games where cognitive and functional~     abilities from geriatric patients could be stimulated and consequently HRQL improved.~      However, a better knowledge of the potential cognitive and functional improvement processes~     from virtual reality rehabilitation in institutional routine is needed to enhance the quality~     and the range of the available care in old adults.~      This study will not only be a validation platform of virtual reality as stand alone~     rehabilitation process but also will assess the cost effectiveness of off-the-shelf gaming~     consoles in HRQL improvement of old adults.~      The investigators will compare the efficacy of two off-the-shelf gaming consoles in HRQL~     changes of patients with Alzheimer disease and related disorders.~      •Method~      This study is a randomized controlled trial that comprises two study phases :~      Phase one; comparing three parallel groups where therapists and assessors will be kept blind~     of study objectives, and Phase two, the investigators will take the most cost-effective~     gaming console from phase one (Nintendo Wii or Xbox 360 Kinect) and the investigators will~     use it as an adjunct to physical therapy compared to physical therapy alone, with respect to~     the same amount of rehabilitation time.~      The interventions are of 120min/week for 6 weeks and a follow-up at 4 weeks after~     intervention.~      Patients will be randomized in either Xbox 360 Kinect group - a Nintendo Wii group - or~     physical therapy as the 'gold' standard condition.~      All groups will receive the same amount of rehabilitation time. Power and sample calculation~     for phase two will be based on phase one results.~   "
164242|NCT01415999|"~     Anthracyclines have been used commonly to treat children with solid tumours and~     haematological malignancies and have led to their increased survival. Nonetheless,~     anthracycline has the side effect of cardiotoxicity. The purpose of this study is to assess~     the impact of anthracycline therapy on heart deformation and fibrosis, heart-vessel~     interaction, usefulness of circulating biomarkers in the assessment of heart function and~     potential genetic predisposition to heart failure in adult survivors of childhood cancers.~   "
164243|NCT01415986|"~     Presently, there is no effective treatment for patients with advanced head and neck cancer~     (AHNC) that failed to respond to the standard therapy (radiation, chemotherapy and surgery)~     in the US. These patients are deemed incurable AHNC. In the European Union (EU), interstitial~     photodynamic therapy (I-PDT) with Temoporfin is approved for the treatment of patients with~     incurable AHNC. Well designed EU studies have shown that I-PDT with Temoporfin can provide~     worthwhile palliation by reducing tumor size, bleeding and pain in 53% - 60% of patients with~     incurable AHNC. This is a significantly higher rate in comparison to the reported response~     rate of palliative chemotherapy (6-30%). However, the EU studies did not correlate~     quantitative tumor response with clinical outcome. In addition, quality of life (QoL)~     improvements associated with I-PDT of AHNC using Temoporfin were also not evaluated.~      The objective of this study is to quantify the tumor response and patient's QoL to I-PDT with~     Temoporfin. Successfully meeting this objective will give us the tools the investigators need~     to design larger studies to significantly improve the management and QoL of patients with~     AHNC.~   "
164244|NCT01415973|"~     This study will compare the effects of cooked, ground beef to those of beef protein isolate~     on blood and muscle proteins.~   "
164245|NCT01415960|"~     Some patients with prostate cancer benefit from androgen deprivation therapy which reduces~     levels of testosterone. Leuprolide is a synthetic Luteinizing hormone releasing hormone~     (LHRH) analogue which upon administration can decrease testosterone levels to ≤0.5 ng/mL.~     Leuprolide Acetate 22.5 mg Depot is a microencapsulated formulation of leuprolide which is~     released slowly over time and effectively reduces testosterone levels in many patients to~     ≤0.5 ng/mL for up to three months. In this study Leuprolide acetate 22.5 mg Depot will be~     administered by intramuscular injection twice over a period of 6 months. The proportion of~     patients with testosterone ≤0.5 ng/mL evaluated over a period of 168 days.~   "
164246|NCT01415947|"~     The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system,~     consists in the ability to adjust (elongate or shorten) the neochordae off-pump to achieve~     an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal~     replacement by enabling accurate sizing of the chords.~   "
164247|NCT01415934|"~     The purpose of this study is to determine if there is a difference in survival rate at 60~     days after enrollment between patients with advanced life-limiting illness for whom statins~     are discontinued vs. for patients with advanced life-limiting illness who are maintained on~     the medication. Secondary outcomes of this study will determine the effects of medication~     cessation on overall survival, important cardiovascular events, quality of life (QOL),~     symptoms, performance status, polypharmacy issues, satisfaction with care, and costs.~   "
164248|NCT01415921|"~     Heart failure, a common heart disease affecting nearly 6 million Americans, is associated~     with high rates of hospitalization and death. Abnormalities in the autonomic nervous system~     are thought to play an important role in the progression of heart failure. This proposal aims~     to determine whether novel application of pyridostigmine, a drug currently approved by the~     FDA only for the treatment of neuromuscular disease, can improve autonomic nervous system~     function in heart failure patients.~   "
164252|NCT01415869|"~     The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD)~     patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood~     test. Also, in patients with gastrointestinal bleeding present, to summarize the extent of~     gastrointestinal bleeding; to examine the behavior of HemoQuant fecal occult blood test over~     time by estimating the proportion of VAD patients with a positive test prior to implantation;~     at one week, one month, three months, six months and one year post implantation, and after~     explantation of the VAD and to evaluate whether presence of any abnormal fecal HemoQuant test~     is predictive of a future major bleeding event.~   "
164253|NCT01415856|"~     The purpose of this study is to determine whether the Torino II device, which emits a pulsed~     electromagnetic field), will help to decrease pain and swelling after knee replacement~     surgery, and thereby decrease the use of narcotic medications after surgery.~   "
164254|NCT01415843|"~     Associated reactions are unintended and involuntary arm movements, normally seen as bending~     of the wrist and elbow, that may occur after stroke when a person is doing something~     effortful such as walking.~      This is the first phase of a study that will investigate the effects that different~     approaches to physiotherapy have on the expression of associated reactions. During this~     phase, current practice among neuro-physiotherapists will be explored in relation to: the~     learning strategies used in stroke rehabilitation, the common interventions used in gait~     re-education, and the strategies adopted for the assessment and management of associated~     reactions.~      The objectives are:~        -  To provide an insight into the learning strategies used by physiotherapists during the~          re-education of walking, including the verbal dialogue that takes place and any~          preferences (overt or subconscious) adopted for one type of learning strategy.~        -  To develop and refine a description of what is meant by the term gait re-education~        -  To provide an insight into how therapists currently manage associated reactions~      This phase of the study will explore these objectives using direct non-participation~     observation of a number of physiotherapy treatment sessions. This will provide an insight~     into the nature of the therapy that takes place for retraining walking(e.g. the types of~     exercises commonly used) and the nature of the learning strategies frequently adopted,~     including the amount and content of explicit verbal instruction and feedback that is provided~     to patients.~   "
164255|NCT01415830|"~     The morbidity associated with scorpion sting intoxication presents an endemic pattern in the~     country, where there are highly venomous species of scorpions so the scorpion sting~     intoxication (IPPA) is considered a medical emergency.~      On the other hand, there is scarce scientific literature from different controlled studies~     evaluating anti-scorpion serum, considering clinical severity scales, lab results and their~     safety. The aim of this study is to compare the efficacy and safety of scorpion sting~     treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).~   "
164256|NCT01415817|"~     Effective colorectal cancer (CRC) screening relies on early identification and removal of~     both polypoid and non-polypoid lesions with neoplastic potential. The investigators~     hypothesize that an intensive training program designed to enhance both recognition and~     classification of lesions with neoplastic potential, will result in an increase in~     non-polypoid adenoma detection in addition to and independent of an increase in overall~     adenoma detection rates.~   "
164257|NCT01415804|"~     The objective of INSTEAD is to compare long-term (5 years) outcomes of endograft prosthesis~     versus medical management in patients with dissection of the thoracic aorta.~   "
164258|NCT01415791|"~     The purpose of this study is to investigate the presence or absence of oral mucosal~     absorption of ICI176,334-1~   "
164259|NCT01415778|"~     The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese~     healthy male subjects.~   "
164260|NCT01415765|"~     Background:~      - MLN4924 is an experimental cancer drug. It may help kill lymphoma cells and make them more~     sensitive to chemotherapy. EPOCH R is a combination chemotherapy drug. It has been effective~     in treating some cases of large B-cell lymphoma. This research will look at two things. The~     first is the effect of MLN4924 on its own in treating large B-cell lymphoma. The second is~     the safe dose and effect of MLN4924 and EPOCH-R in combination when treating large B-cell~     lymphoma.~      Objectives:~        -  To study how MLN4924 affects large B-cell lymphoma tumors.~        -  To compare the effects of MLN 4924 alone and MLN4924 plus standard EPOCH-R chemotherapy.~      Eligibility:~      - Individuals at least 18 years of age who have large B-cell lymphoma that will be treated~     with chemotherapy.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, tumor samples, and imaging studies.~        -  Participants will receive MLN4924 for a maximum of six 21-day cycles of treatment. Each~          cycle involves a dose of MLN4924 twice a week for 2 weeks, followed by a 1-week rest~          period. Participants will be monitored with frequent blood tests and imaging studies.~        -  Participants who do not benefit from MLN4924 alone will have MLN4924 along with EPOCH-R~          chemotherapy for up to six cycles of treatment.~   "
164261|NCT01415752|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.~     Others interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer~     cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell~     lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab~     together with bendamustine and bortezomib is more effective than rituximab and bendamustine,~     followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.~      PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and~     lenalidomide in treating previously untreated older patients with mantle cell lymphoma.~   "
164262|NCT01415739|"~     This research studies protein in tumor samples from patients with non-small cell lung cancer.~     Finding specific proteins in tumor tissue samples from patients with cancer may help doctors~     tell what type of lung cancer a patient has and plan better treatment.~   "
164302|NCT01415219|"~     The purpose of this study is to evaluate the efficacy of an active rehabilitation program on~     disability and quality of life of patients affected by dermatomyositis and polymyositis.~   "
164263|NCT01415726|"~     Type 2 diabetes is the most common form of diabetes. The prevalence of diabetes has been~     markedly increased in recent years. More and more children and young adults develop this~     devastating disease. Despite of multiple factors (e.g., food, environmental, and genetic~     factors) contributing to the developing of diabetes, increasing evidence demonstrated that~     chronic inflammation and/or atuoimmunity are common issues and play key roles in the~     pathogenesis of type 2 diabetes, leading to the insulin resistance and the shortage of~     insulin-producing islet beta cells. Thus, anti-inflammation is becoming a novel approach for~     the treatment of type 2 diabetes. Evidence that multipotent stem cells derived from human~     cord blood (CB-SCs) can control inflammation and autoimmune responses by altering regulatory~     T cells (Tregs) and human islet beta cell-specific T cell clone in type 1 diabetes offers~     promise for a new approach to treat type 2 diabetes. Here, the investigators develop a novel~     Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Stem~     Cell Educator therapy in T2D patients.~   "
164264|NCT01415713|"~     Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen~     Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary~     objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease~     control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor~     progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study~   "
164265|NCT01415700|"~     The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after~     central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve~     the patient's walking floor by removing the STEPPAGE, reducing the effort of walking,~     facilitating the flow and removing anomalies compensatory (such as the mowing of the hip).~     Its objective is to improve the patient's autonomy locomotor.~      The aim of this study is to compare the results of the implementation of an implanted~     stimulator in the levator muscles of the foot to the results obtained by wearing a~     splint-type reliever, which is considered standard treatment, in order to determine if the~     implanted stimulation may be proposed in the treatment of foot drop off a neurological~     center.~   "
164266|NCT01415687|"~     The objective of this study is to compare the efficacy, safety and tolerability of two bowel~     preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax~     plus Bisacodyl - with a specific emphasis on the right colon cleanliness.~      The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of~     preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes~     will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.~   "
164267|NCT01415674|"~     The purpose of this study is to identify predictive and pharmacodynamic biomarkers of~     activity and efficacy of pre-operative Afatinib (BIBW2992) in untreated non-metastatic head~     and neck squamous cell carcinoma patients~   "
164268|NCT01415661|"~     This investigation was designed to assess the patency of the esophageal entrance during~     cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the~     Glidescope ® video laryngoscope (GVL).~   "
164269|NCT01415648|"~     In France, in 2007, 17 000 patients underwent carotid endarterectomy. The risk of having an~     ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%. There is no~     consensus concerning the best cerebral monitoring and hemodynamic optimisation during carotid~     cross-clamping.~      The objective of this prospective, multicentric, double-blinded and randomized study is to~     evaluate the interest of continuous cerebral oximetry monitoring by INVOS™ cerebral oximeter~     to direct the hemodynamic optimisation during carotid endarterectomy and reduce the new-onset~     of postoperative radiological (MRI) ischemic lesions. A cost/effectiveness analysis will be~     conducted to estimate the impact of this monitoring versus standard care on direct and~     indirect postoperative costs during 120 days.~      A substudy will evaluate the effect of this monitoring on neurocognitive outcome and on a~     serum marker of brain injury, protein S-100B~   "
164270|NCT01415635|"~     Background:~      The investigators have previously documented that patients at nutritional risk lack~     sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized~     historically controlled intervention study of 40 patients at nutritional risk. The study~     indicated that a tailored food concept increased nutritional intake in this patient group.~      The objective of the current study is therefore to investigate these findings in a randomized~     clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of~     their energy and protein requirements.~      Methods:~      The study will compare standard nutritional care (control group) with tailored nutritional~     care (the possibility to order small energy and protein-enriched dishes called Delights of~     Herlev Hospital). 96 patients at nutritional risk, according to the NRS-2002 criteria, will~     be included in the study.~   "
164271|NCT01415622|"~     The purpose of this study is to prove the safety and efficacy of plasma as an add-on~     treatment in combination with conventional treatment in cases of chronical venous Ulcus~     cruris.~   "
164272|NCT01415609|"~     The purpose of this study is to monitor the success rates and completion rates for endoscopic~     submucosal dissection (ESD) for gastrointestinal (GI) cancers.~   "
164273|NCT01415596|"~     Many athletes use beta2-agonists as treatment of airway hyperresponsiveness during exercise.~     High dose beta2-agonists may have an ergogenic effect on exercise performance. We hypotheis~     that the beta2-agonist, salbutamol, taken in high doses can improve muscle power and recovery~     during exercise in well-trained athletes.~   "
164274|NCT01415583|"~     Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after~     tonsillectomy is one of the risks of this surgery and can be more dangerous in children since~     they have less blood volume than adults. In order to improve recovery after tonsillectomy,~     steroids (medication that is a strong anti-inflammatory) are often given during the surgery.~     Recently, a study showed steroids given at the time of tonsillectomy increase the risk of~     bleeding significantly over children who did not receive steroids. This finding has raised~     concerns in the Ear, Nose, and Throat (ENT) community since most ENT's use steroids during~     tonsillectomy in children. The investigators look to explore this question further.~      To answer the question of whether perioperative steroid administration significantly affects~     the rate of post-tonsillectomy bleeding, the investigators propose to test the following~     hypotheses in a prospective, randomized, blinded placebo-controlled trial: dexamethasone does~     not cause an increase in post-operative bleeding rate in tonsillectomy.~   "
164275|NCT01415570|"~     In the United States, African Americans are 3.6 time and Hispanics 1.5 times more likely to~     suffer from chronic kidney disease and need dialysis treatment for life, when compared to the~     non-Hispanic Whites. Unfortunately many dialysis patients die, so that after 5 years only~     less than 35% are still alive. Dialysis patients who appear malnourished or who have muscle~     and fat wasting are even more likely to die. Interestingly, among dialysis patients,~     minorities (African Americans, Hispanics and Asian Americans) usually survive longer than the~     non-Hispanic Whites. If the investigators can discover the reasons for these so-called~     racial survival disparities of dialysis patients, the investigators may be able to improve~     survival for all dialysis patients and maybe even for many other people who suffer from other~     chronic diseases. During this 5 year study the investigators would like to test if a~     different nutrition and diet can explain better survival of minority dialysis patients. The~     investigators will also test if in additional to nutrition there are 2 other reasons for~     better survival of minority dialysis patients, namely differences in bone and minerals and~     differences in social and psychological and mental health. The investigators plan to study~     450 hemodialysis patients every 6 months in several dialysis clinics in Los Angeles South Bay~     area. These subjects will include 30% African Americans, 30% Hispanics, 30% non-Hispanic~     Whites and 10% Asians. Every 6 months the investigators will examine their nutritional~     conditions, dietary intake, psycho-social conditions and quality of life, and will recruit 75~     new subjects to replace those who left our study as a result of kidney transplantation, death~     or other reasons. Hence, the investigators estimate studying a total of 1,050 hemodialysis~     patients over 5 years. Clinical events such as hospital admissions and survival will be~     followed. Blood samples will be obtained every 6 months for measurements of hormones and~     biomarkers, and the remainder of the blood will be stored in freezers for future~     measurements. The investigators plan to design and develop race and ethnicity specific~     nutritional risk scores and food questionnaires and will test some of these scores in larger~     national databases of hemodialysis patients. Almost a year after the study starts, the~     investigators also plan to do additional tests of body composition and dietary intake in a~     smaller group of these patients at the GCRC.~   "
164276|NCT01415557|"~     The purpose of this study is to assess the impact of regular consumption of micronutrient~     fortified drink in improving nutritional and micronutrient status in Indian school children.~     The test beverage will be fortified with both, vitamins and minerals.~   "
164277|NCT01415544|"~     The purpose of the study is to prospectively evaluate a noninvasive, near-infrared based~     method for measuring glucose concentration relative to invasive blood reference measurements.~     The initial phase of the study will be focused on procurement of the data needed to develop a~     robust, accurate calibration. The second phase will be focused on performance evaluation of~     the system.~   "
164278|NCT01415531|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of~     therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with~     stage 1 or stage 2 essential hypertension.~   "
164279|NCT01415518|"~     Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD)~     patients.~   "
164280|NCT01415505|"~     The purpose of this study is to evaluate the safety and tolerability of nebivolol and~     valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential~     hypertension.~   "
164281|NCT01415492|"~     This study (aka Healthy Directions2 or HD2) builds on an earlier study titled Healthy~     Directions (aka Healthy Directions 1 or HD1). HD1 was an intervention designed to target~     cancer prevention among multi-ethnic populations; it led to significant improvements in the~     multiple risk behavior score (consumption of red meat, fruits and vegetables, and~     multi-vitamins). Building on the success of HD1, HD2 further expanded the intervention to~     include smoking and physical activity. In addition, it expanded the study goals to include~     increasing efficacy across all target risk behaviors, and promoting long-term maintenance of~     behavior change.~   "
164282|NCT01415479|"~     Fifty thousand people die from colorectal cancer (CRC) every year, making it the second~     leading cause of death from cancer in the United States. And although there are multiple~     screening tests that reduce the morbidity and mortality of this disease, less than 60% of~     eligible individuals are up to date with recommended screening.~      One of the challenges to improving screening is helping patients understand the range of~     approved tests, including colonoscopy, sigmoidoscopy, and stool testing (such as fecal~     immunochemical testing (FIT)). Patients rarely consider all their options, partly due to the~     limited time they have to learn about them during busy doctor's visits.~      Computer-based presentations, including decision aids, are a promising tool for improving~     patient understanding in this and other areas, by giving patients significant amounts of~     information.~      But there are important questions about how to design such presentations, including whether~     they should provide quantitative data about the risks and benefits of screening. Some experts~     feel that these numbers and graphs are necessary for fully informed decision-making, while~     others are concerned that they may confuse patients or dissuade them from screening.~      The investigators have created and pilot tested a computer-based presentation of quantitative~     information about CRC screening. The investigators found that subjects who viewed the program~     in a non-healthcare setting exhibited significantly increased interest in screening. In~     addition, the investigators tested a version of the program that includes a nudge towards~     stool testing with FIT, as a way of encouraging individuals who are confused to undergo some~     form of screening. In our testing, receiving the nudge was associated with a significant~     increase in interest in FIT.~      The investigators now seek to conduct a randomized, controlled study of our computer-based~     presentation with Clarian patients who are due for CRC screening. All subjects will first~     view a general video about CRC screening and then will be randomly placed into four groups~     (using a 2x2 design), to receive quantitative information (or not), and a nudge towards FIT~     (or not).~      The results will determine whether a presentation of quantitative information can increase~     patient understanding, quality of decision-making, and uptake of CRC screening. The results~     will serve as pilot data for a larger, externally funded study of the effect of~     individualized (personalized) quantitative information in this area~   "
164283|NCT01415466|"~     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug~     interaction between rosuvastatin and CS-866 in healthy male volunteers.~   "
164284|NCT01415453|"~     Retinitis pigmentosa (RP) is the name given to a group of inherited eye diseases that affect~     the retina (the light-sensitive part of the eye). RP causes the breakdown of photoreceptor~     cells (cells in the retina that detect light). Photoreceptor cells capture and process light~     helping us to see. As these cells breakdown and die, people experience progressive vision~     loss. There is no known cure for retinitis pigmentosa. The investigators have observed that~     short pulses of focused ultrasound can cause perception of light when directed to spots on~     the retinal surface. The investigators propose to conduct a study to determine if pulsed~     ultrasound will stimulate the perception of light in the absence of functional photoreceptors~     in people with RP~   "
164299|NCT01415258|"~     The objective of this study is to uncover the prevalence of vulnerability among patients aged~     ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the~     short screening test Vulnerable Elders Survey 13 (VES-13).~      The objective is to better understand the value of routine screening of patients before the~     consultation, it was proposed as a secondary objective of this study to assess the~     correlation between the identification of the vulnerability in the screening test VES-13 and~     the identification made by the clinician during the consultation. The correlation between~     VES-13 and opinion of the clinician for three categories of patients (self - intermediate -~     fragile) will also be studied.~   "
164300|NCT01415245|"~     Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and~     effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in~     patients with coronary heart disease.~   "
165109|NCT01404572|"~     The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use~     (POU) formulations to the current atazanavir POU in healthy participants and to select 1~     atazanavir POU that has the sweetness most similar to the current atazanavir POU.~   "
164285|NCT01415440|"~     The aim of this study is to examine the mechanisms by which stimulant medications reduce~     symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic~     Resonance Imaging (MRI), the investigators have found that the volumes of certain brain~     regions are reduced in patients with ADHD. The reduced volumes were much less pronounced if~     patients had been treated with stimulant medications, suggesting that stimulants may reduce~     the symptoms of ADHD by reversing these volume reductions. In a second and related study, the~     investigators found that in patients with ADHD, emotional processing was normalized when~     patients were taking stimulant medications. Both studies point to possible mechanisms by~     which stimulants are effective; however, a significant limitation of these findings is that~     they were derived from cross-sectional studies.~      In this current study, the investigators hope to replicate these treatment effects of~     stimulants in a prospective, controlled manner. The investigators plan to measure ADHD~     symptom severity in patients before and after 12-weeks of controlled treatment with either a~     stimulant medication or placebo while utilizing structural and functional MRI. Combining~     imaging with a randomized controlled trial will allow us to better assess the effects of~     stimulants on brain function and structure.~   "
164286|NCT01415427|"~     This Phase 3 extension study will evaluate the long-term efficacy and safety of BMN 110 2.0~     mg/kg/week and/or BMN 110 2.0 mg/kg/every other week in patients with mucopolysaccharidosis~     IVA (Morquio A Syndrome).~   "
164287|NCT01415414|"~     It is a prospective, non-interventional, multi-center study. The primary objective of this~     study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced~     CT considering the routine use in patient population's, region's indication.~   "
164288|NCT01415401|"~     The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®~     from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients~     with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).~   "
164289|NCT01415388|"~     The purpose of this study is to assess the effect of 12 weeks of daily supplementation with~     Superba(TM) Krill Oil on fasting serum triglyceride levels and omega-3 index in subjects~     whose habitual fatty fish and seafood intake is low and who have borderline high or high~     fasting serum triglyceride levels.~   "
164290|NCT01415375|"~     This study evaluates the efficacy of a tailored telephone intervention to promote informed~     decision making about prostate cancer testing among predominantly immigrant black men.~   "
164291|NCT01415362|"~     In this pilot study, the researchers investigated the feasibility of a closed-loop~     electroencephalography (EEG) / transcranial direct current stimulation (tDCS) system for~     treatment of epilepsy. They looked to see the feasibility of triggering tDCS stimulation~     within 10 seconds of a detected EEG partial-onset seizure, and also a proof-of-principle~     determination of whether tDCS applied during this vulnerable period may be feasible to~     prevent the oncoming seizure.~      This study required 5 visits over the course of approximately 8 weeks. Each visit was~     separated by at least 2 weeks. Two of the visits had 24-hour EEG monitoring sessions. During~     these two sessions, the EEG and tDCS were hooked into a closed loop system, such that when~     seizure activity wasdetected, the tDCS was triggered to deliver stimulation. Subjects~     received active stimulation or sham stimulation sessions during the first 24-hour visit, and~     the opposite during the second. The subjects were randomized and counterbalanced.~      We have also added a healthy subjects cohort to assess the feasibility of the closed loop~     system. In order to test the proof-of-concept of this system, the experiment will focus on~     detecting and acting upon alpha- and beta-band changes traced in the EEG activity that is~     being recorded, and provide tDCS stimulation based upon those changes. We will enroll 6~     subjects who will have 2 visits each. During these two visits subjects will be randomized to~     active or sham stimulation sessions and receive the opposite during their second visit.~   "
164292|NCT01415349|"~     This is a drug interaction study evaluating whether blood plasma concentrations of~     SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.~   "
164293|NCT01415336|"~     Capecitabine has shown high efficacy in metastatic and adjuvant settings. This is a~     prospective, randomised trial, to compare the efficacy and safety profiles of~     capecitabine-containing regimen with non- capecitabine-containing adjuvant chemotherapy~     regimens for node negative breast cancer patients.~   "
164294|NCT01415323|"~     Agitation is associated with a number of acute psychiatric conditions, and frequent in acute~     psychiatric admissions. It is associated with violence towards others, and strongly~     associated with in-patient suicides.~      The main aims of the study are to assess different clinical presentations of agitation at~     admittance, and to assess the consequences of these different clinical presentations during~     the first three days of the stay.~   "
164295|NCT01415310|"~     QualGeP (KVALAP) is a quality register in Viken Research network for Geriatric Psychiatry.~     The objectives of the register are to enhance our knowledge of old persons with severe~     psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for~     these patients. The data in the register will be used for quality assurance and for research.~      Aims:~        -  Quality assurance~        -  Further development of our diagnostic and screening tools~        -  Contributing to improving the treatment, with and without drugs~        -  Contributing to improving the dialogue and collaboration between primary healthcare and~          hospitals~   "
164296|NCT01415297|"~     The purpose of this study is to determine the safety and maximal tolerated dose of NKP-1339,~     a ruthenium containing compound administered intravenously on a weekly schedule, in patients~     with advanced solid tumors. The responses to treatment in this population will be evaluated.~     In addition, the PD and PK properties of the compound will be explored.~   "
164297|NCT01415284|"~     The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4~     which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women~     undergoing a cesarean section under spinal anesthesia.~   "
164298|NCT01415271|"~     The incidence of type 2 diabetes in long term care facilities has been approximated at 25%~     with barriers to treatment including untimely access to a specialist and improper/poor~     adherence to insulin regimes. This 3 month trial will investigate the efficacy of improving~     overall glycemic control by using an internet blood glucose reporting system to facilitate~     bi-weekly consultations between long term care facility patients with type 2 diabetes and an~     endocrinologist.~   "
164304|NCT01415193|"~     The purpose of this study is to analyse the ability to selectively block the posterior tibial~     nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking~     the posterior tibial nerve will give the same post-operative pain relief after total knee~     surgery compared to a sciatic nerve block.~   "
164305|NCT01415180|"~     Sepsis represents the leading cause of childhood mortality worldwide. However, as distinct~     from adult medicine, there exists a large knowledge gap regarding long term health related~     quality of life (HRQL) and functional status (FS) following pediatric sepsis. This lack of~     sepsis outcomes data is critical because failure to identify children at risk for sepsis~     associated HRQL/FS deterioration may delay delivery of crucial rehabilitation medicine~     efforts to facilitate recovery. Moreover, failure to identify mechanisms of sepsis associated~     HRQL/FS deterioration may impede development of novel, effective interventions for these~     children. For the first time the LAPSE investigation will quantify deterioration of HRQL/FS~     among children surviving sepsis. We will measure the incidence, magnitude and duration of~     HRQL/FS alterations associated with pediatric septic shock, and examine clinical,~     sociodemographic, and parent/family factors potentially associated with such adverse~     outcomes. Because sepsis affects a heterogeneous group of children, long term morbidity~     associated with sepsis likely depends on premorbid health status and parent, family and home~     characteristics, as well as children's clinical course during sepsis critical illness.~     Mechanisms underlying adverse sepsis outcomes among children are poorly understood at this~     time. Clinically multiple organ dysfunction syndrome (MODS)has been clearly linked to sepsis~     mortality. To begin to understand pathophysiology underlying pediatric sepsis morbidity, this~     investigation will seek to identify evidence for association of HRQL/FS alterations following~     sepsis with intensity and duration of sepsis mediated organ dysfunction as well as with~     pre-existing comorbidities and parent, family, and home characteristics. Thelong term goal of~     this research program is to timely identify children at high risk of sepsis mediated HRQL/FS~     deterioration and ultimately to design effective interventions to minimize such risk. The~     primary objectives of this investigation are to comprehensively characterize HRQL/FS~     trajectory and to critically examine the potential role of sepsis mediated organ dysfunction~     as well as pre-existing comorbidities and parent, family,and home characteristics as risk~     factors for the adverse outcomes. The central hypothesis is that intensity of sepsis organ~     dysfunction will predict magnitude of HRQL/FS deterioration. We also hypothesize that the~     trajectory towards baseline HRQL/FS following the sepsis event will also depend on~     pre-existing co-morbidities and parent, family, and home, and characteristics. Knowledge of~     these potential mechanisms will ultimately facilitate development of targeted interventions~     to maximize HRQL/FS among children surviving sepsis.~   "
164306|NCT01415167|"~     The purpose of this registry is to collect information on patients who are receiving~     treatment with Proleukin in an organized way, and to learn more about patient care during and~     after treatment.~   "
164307|NCT01415154|"~     The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial~     Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic~     worsening in patients who have shown a clinical response to acute TMS treatment.~   "
164308|NCT01415141|"~     Chronic hepatitis C is a major cause of liver disease and is thus an important public health~     problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to~     treatment with a combination of peginterferon and ribavirin, the most common form of the~     virus (genotype 1) is relatively resistant to this treatment. Recently, telaprevir has been~     approved by the Food and Drug Administration to be given in combination with peginterferon~     and ribavirin. This 3-drug combination boosts the remission rate for genotype 1 hepatitis C~     to that seen with other more responsive hepatitis C genotypes treated with only peginterferon~     and ribavirin. However, telaprevir has additional side affects such as rash and anemia that~     may limit its usefulness. Intriguingly, about one third of patients infected with genotype 1~     hepatitis C, who have a specific variation (polymorphism) in the DNA sequence (CC) near an~     immune response gene (IL28B), in fact are highly responsive to 2-drug treatment with~     peginterferon and ribavirin. This raises the possibility that individuals who have the IL28B~     CC polymorphism may not need to be treated with the addition of telaprevir and could~     therefore be spared unnecessary side effects. Thus, the purpose of this study is to determine~     among genotype 1 hepatitis C patients with the IL28B CC polymorphism the success rate and~     side effects of 3-drug treatment compared with 2-drug treatment.~      In this study, patients with genotype 1 chronic hepatitis C who have the IL28B CC~     polymorphism will be randomly assigned to be treated with telaprevir, peginterferon, and~     ribavirin or with only peginterferon with ribavirin. These medications and the procedures~     involved, including patient history, physical examination, and obtaining small volume blood~     specimens (less than 4 teaspoons) for laboratory testing, are within the scope of standard~     management of hepatitis C treatment. All patients will be monitored during treatment with~     periodic blood testing (weeks 2, 4, and every 4 weeks thereafter while on treatment, and 24~     weeks after stopping treatment) and office visits (weeks 5, 12, 25, 49 while on treatment and~     25 weeks after stopping treatment). The success of treatment will be judged by the presence~     or absence of detectable virus in blood, as measured by a sensitive diagnostic test (PCR).~     The data to be generated will include measurement by PCR of hepatitis C viral loads before,~     during, and after treatment, as well as reporting of adverse drug effects.~   "
164309|NCT01415128|"~     This study will compare the pharmacokinetics of omeprazole, rosiglitazone and desipramine~     when administered with a single oral dose of avanafil in healthy male subjects.~   "
164310|NCT01415115|"~     The trial is designed as a feasibility study to determine the correlation of noninvasive~     measurements of AGE with the SCOUT device to diabetes complications.~   "
164311|NCT01415102|"~     The purpose of this study in healthy people is to evaluate safety, toleration and time course~     of plasma concentration of single inhaled doses of PF-05212372.~   "
164312|NCT01415089|"~     The purpose of this pilot study is to develop a personalized, interactive, and web-based~     module for cancer patients and a family caregiver. The three-session module will be designed~     to help patients and family caregivers improve their communication and support.~   "
164313|NCT01415076|"~     Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon~     distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted~     through the lungs. This reduces the effects of colonic distension and minimizes intracolonic~     gas at the end of the examination. The aims of the study were to evaluate the timing of~     administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.~   "
164314|NCT01415063|"~     The combination of transcatheter arterial chemoembolization (TACE) with RFA has also reported~     to be an effective treatment for HCC. Studies have shown TACE combined RFA to have better~     efficacy than RFA for medium-sized HCC (3-5 cm) and multiple-tumor HCC, but not for small HCC~     (≤3 cm). However, to our knowledge, there have not been any prospective studies to assess~     whether TACE combined sequentially with RFA is more effective than RFA alone for the~     treatment of HCC recurrence after curative treatment. We hypothesized that the combination of~     TACE and RFA might result in better patient survival than RFA alone. Thus, the purpose of~     this study was to prospectively compare the effects of sequential TACE-RFA with RFA alone for~     the treatment of recurrent HCC. Recurrent HCC in this study was defined as new tumors in the~     remnant liver, distant from the resection or ablation site after curative treatment of RFA or~     hepatectomy.~   "
164334|NCT01414803|"~     Although the combination of statin and fenofibrate is one of the options for patients with~     combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. In~     this study we compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and~     rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney, blood~     glucose control, and blood cell counts.~   "
164335|NCT01414790|"~     The aim of the study was to explore whether human acellular dermal matrix (ADM) implantation~     could prevent infraauricular depressed deformities and Frey's syndrome following total~     parotidectomy.~   "
164373|NCT01414283|"~     Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label,~     dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive,~     castration-resistant, metastatic prostate cancer that has progressed after prior taxane~     therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.~   "
164315|NCT01415050|"~     Multicentered, randomized study of safety and efficacy of whole-body vibration (WBV) as add~     on to standard pharmacological treatment of osteoporosis (alendronate 70 mg/ week or~     raloxifene 60 mg/day) in post-menopausal women.~      After informed consent of the patients has been obtained, each patient's potential~     eligibility will be assessed during a Screening Visit. Eligible subjects will be stratified~     into two groups: those that are on treatment with alendronate and those that are on treatment~     with raloxifene.~      Subsequently, at baseline, the patients in each group are randomised to receive either WBV or~     no WBV during the first segment of the study. Baseline evaluation of biomarkers of bone~     remodelling, fall risk and back pain will be performed before starting the first segment.~     Patients will return for efficacy and safety evaluations at week 3 and week 6. At 6 weeks~     after baseline the second segment of the study starts: patients that were on WBV during~     segment I will be observed for another 6 weeks without WBV, whereas the patients that did not~     receive WBV during segment I will now be treated with WBV for 6 weeks in segment II. All~     patients will return for additional visits at week 9 and 12 for safety and efficacy~     evaluation.~   "
164316|NCT01415037|"~     The objective of this research is to improve the care of ocular disease and disorders, in~     particular the changes in the eye associated with diabetes, by providing clinicians with~     dramatically improved ultrasonic images of the entire eye. The research combines advanced~     high-frequency, high-resolution ultrasonic annular arrays transducers with new processing~     techniques designed to overcome several limits that have been reached with conventional high~     frequency ultrasound systems. The investigators propose that diagnosis of eye diseases using~     annular arrays can be more effective than the conventional ultrasound images by at least 50%;~     i.e., that for every 2 posterior vitreous detachments detected conventionally, 3 will be~     detected with the annular arrays.~   "
164317|NCT01415024|"~     Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2~     ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral,~     gaining a responder rate of approximately 70%. However, the physiological agitation of the~     left ventricle takes place over two pathways. Therefore single point stimulation might be~     insufficient for a dilated, insufficiently and asynchronously contracting left ventricle,~     resulting in either insufficient or no response to the therapy.~      In the CRT ICD Dual LV study the patients receive a second LV lead in an anterior vein.~     When this lead is placed, temporary dual LV stimulation is started. To assess the effectivity~     of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement is taken. If~     there is an increase in LV dp/dt, the patients will be stimulated with both leads~     permanently. If not they will be stimulated conventionally.~      The patients participating in this study are monitored for 12 months after implantation.~   "
164318|NCT01415011|"~     The purpose of this study is to examine the efficacy and safety of using afatinib (BIBW 2992)~     to treat non-small cell lung cancer patients considered unfit for chemotherapy and have~     either suspected or confirmed Epidermal Growth Factor Receptor (EGFR) mutation.~   "
164319|NCT01414998|"~     There are currently two sensorimotor replacement products which may be of benefit in smoking~     cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the~     purpose of this project is to investigate whether these replacements can help to alleviate~     tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be~     separated into two studies, following the same design and procedures.~      Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy of~     a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool~     (e.g. stress ball) which provides no smoking-related cues.~      Study 2 will investigate whether sensorimotor replacements which are more proximal to smoking~     (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a replacement~     which only delivers some of the conditioned sensorimotor cues (i.e. ECs).~      The investigators hypothesise that the EC will be more effective at reducing withdrawal~     symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the~     Denic will be more effective than the EC.~   "
164320|NCT01414985|"~     The investigators propose to assess the safety and efficacy of a new administration method to~     deliver a biologic to children with a form of Batten disease using an experimental gene~     transfer procedure. This gene transfer procedure consists of delivering a good copy of the~     mutated gene to the nerve cells via a virus. These children are born with genetic changes~     called mutations that result in the inability of the brain to properly recycle proteins. The~     recycling failure leads to death of the nerve cells in the brain and progressive loss of~     brain function. Children with Batten disease are normal at birth but by age 2 to 4 have motor~     and vision problems which progress rapidly to death at age approximately 10 years old. There~     are no therapies available to treat the disease.~      The investigators previous clinical trial used a virus called adeno-associated virus 2 (AAV2)~     as the gene delivery system. That study showed that viral delivery of the gene was safe and~     showed small, but significant benefits to the recipient. The investigators currently have an~     IRB approved protocol which uses a slightly different virus called AAVrh.10 as the gene~     delivery system. This 3rd protocol proposes to use the same virus AAVrh.10 as the gene~     delivery system and has expanded the eligibility criteria.~   "
164321|NCT01414972|"~     The aim of this study is the comparison between the effects of supplementation with 25000 IU~     preformed vitamin A (retinyl palmitate) or placebo for 4 months on gene expression of T CD4+~     lymphocyte in atherosclerotic patients(documented with angiography).~   "
164322|NCT01414959|"~     The investigators will measure the pharmacokinetics of doripenem in skeletal muscle,~     subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care~     patients.~   "
164357|NCT01414504|"~     Recently, controversy has emerged regarding the role of the 23vPPV in infants due to~     potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat~     vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated~     protective efficacy against acute lower respiratory tract infection, the investigators feel~     it is a matter of urgency to determine if 23vPPV administration provides elevated antibody~     concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV~     in infants.~      Following consent and eligibility assessment, a baseline blood sample and nose swab will be~     taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab~     will be collected 28 days later. The investigators will also collect data on incidence of~     ALRI in all study participants by medical record review.~   "
164323|NCT01414946|"~     Loss of muscle protein and mass are the main causes of fatigue after bowel surgery which may~     result in a longer hospital stay and a higher rate of complications. This problem is~     especially important for patients after surgery for bowel cancer because cancer itself causes~     a waste of muscle protein. Anesthesiologists can decrease these negative effects of surgery~     by choosing the type of pain treatment (analgesia) and by giving nutrition (sugar and~     protein). Our group recently observed that optimal pain relief with epidural catheters (these~     are placed in the so called epidural space, which lies between the spine and the skin of the~     back) in combination with a low calorie protein diet intravenously (through the vein)~     maintains the body's protein stores after bowel surgery.~      The goal of our new research program is to find out whether this protein saving effect~     depends on how protein depleted the patient is before surgery. In other words we would like~     to answer the question: do cancer patients who show protein wasting before the operation~     benefit more from feeding than patients who show no signs of protein wasting? A second goal~     of this program is to find out if we need to use sugar as part of the diet or whether the~     infusion of protein alone is sufficient. Just giving protein would make feeding not only~     easier but also would avoid the increase in the patient's own blood sugar during and after~     the operation, which typically occurs when sugar is given intravenously during that period.~   "
164324|NCT01414933|"~     High sensitivity to targeted agents has been observed in patients whose tumor cells present a~     genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR~     mutations) together with addiction to the given target. More recently, activation of~     alternative pathways (Kras mutation, PI3K mutations) have been reported as a common~     resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab).~      From these data has emerged the hypothesis that identification of the deregulated pathway~     through new molecular tools could allow to propose a more tailored targeted regimen.~      Based on these concepts, numbers of phase I/II trials enrich their populations in patients~     presenting specific molecular alterations.~      High throughput technologies (array CGH, sequencing, gene expression array) identify~     deregulated genes. In addition, these technologies determine whether such genomic alterations~     are single (expected efficacy of single agent) or multiple (rationale for combination). In a~     pilot study that included 135 patients, we recently performed a combination of array CGH and~     hot spot mutation array in order to drive patients into phase I/II clinical trials. This~     study led to the conclusions that high throughput technologies i. are feasible (80%) and~     robust, ii. identify targetable genomic alterations in around 40% of samples.~      In the present study, the investigators will perform high throughput technologies to drive~     400 metastatic breast cancer patients into specific phase I/II trials.~   "
164325|NCT01414920|"~     The purpose of this study is to determine the efficacy and safety of TAK-875, once daily~     (QD), in combination with sitagliptin QD in participants with type 2 diabetes mellitus~     (T2DM).~   "
164326|NCT01414907|"~     The purpose of this study is to evaluate the effect of adding the Health Promotion activities~     and rehabilitation to the usual alcohol and drug interventions on the outcome for alcohol and~     drug abusers compared to the usual intervention alone.~   "
164327|NCT01414894|"~     The purpose of our study is to determine how well Triple-H works and how safe it is. The~     investigators are hoping to determine the effects of starting the therapy early and to~     explore if hypervolemia and/or hypertension are beneficial, and what the optimal target~     ranges are.~   "
164328|NCT01414881|"~     The primary objective of this Phase I exploratory study is to determine the effects of~     mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density~     lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period,~     a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment Period~     with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total duration~     of any given subject's participation will be approximately 40 weeks.~   "
164329|NCT01414868|"~     Background: Therapeutic outcomes of leukotriene receptor antagonist (LTRA) vary in~     asthmatics，and there's not an ideal and simple way for prediction at present.~      Objective：To investigate whether leukotriene D4 bronchial provocation test (LTD4-BPT) could~     be an indicator of actual therapeutic outcome of LTRA.~      Methods：A single centre, open-labeled trial was performed in 32 asthmatics with positive~     LTD4-BPT result for a month. All subjects were categorized according to airway responsiveness~     to leukotriene D4（PD20FEV1-LTD4）. Subjects received montelukast therapy (10mg, once per~     night), and reassessment was performed (3~5) days after withholding LTRA. The primary~     end-point was the difference in monthly PEFR. Secondary endpoints included the difference in~     FENO, PD20FEV1-LTD4, PD20FEV1-MCh, pre-test FEV1, ACT score, AQLQ symptom score, week 4~     PEFmax and PEFmin as compared with week 1, gradual decrease in the use of salbutamol and the~     days without using salbutamol.~   "
164330|NCT01414855|"~     This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab~     [RO5072759 (GA101)] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine,~     Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients~     will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle,~     during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP~     chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction~     of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of~     approximately 15 patients are planned to be enrolled at a subset of investigational sites.~   "
164331|NCT01414842|"~     Aim of the present randomized controlled multinational trial is the comparison of a novel~     biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy,~     with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic~     overall and cardiovascular stability.~   "
164332|NCT01414829|"~     Gastric biopsies will be taken to compare different methods of H.pylori disclosure.Standard~     methods will be compared to culture.~   "
164333|NCT01414816|"~     To identify problems/questions about following items in the clinical practice using Betaferon~        1. Unknown adverse event (especially serious adverse event)~        2. Identification of adverse event occurred in the real practice~        3. Factors that may affect the safety of drug~        4. Factors that may affect the effectiveness of the drug~   "
169673|NCT01344668|"~     The primary hypotheses are that the intervention will improve A1C, blood pressure, lipids,~     weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24~     months follow-up.~   "
164336|NCT01414777|"~     The investigators hypothesize that given prophylactically, intravenous ondansetron will~     attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia.~      Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in~     preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo~     elective caesarean section will be enrolled.~      Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous~     ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of~     saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy~     will randomize and dispense study drug.~      Baseline measurements of vital signs will be taken. Otherwise standard management will then~     be used:~        -  Patients must be NPO for 8 hours~        -  Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3~          minutes, more frequently if decided by the provider.~        -  Standard lumbar puncture in a sitting position the L3-L4 or L4-L5~        -  Whitacre pencil-point, 25 gauge~        -  Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20~          mcg fentanyl~        -  Immediately after completing the subarachnoid injection, patients will be laid supine~          with left lateral uterine displacement~      The sensory level of anesthesia will be assessed in the standard fashion every five minutes~     using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0,~     no paralysis; 1, inability to lift the thigh [only knee/feet]; 2, inability to flex the knee~     [only feet]; 3, inability to move any joint in the legs).~   "
164337|NCT01414764|"~     The aim of this study is to establish if the application of autologous conditioned plasma~     (ACP), also described as platelet rich plasma (PRP), to the site of supraspinatus tendon~     repair beginning within two weeks of surgery, can improve patient outcomes over the course of~     12 months. These outcomes will be measured by post-surgical pain and function scores,~     shoulder strength and range of motion (ROM), and radiological parameters of tendon healing.~     Outcome measures will be compared to a control group of patients receiving placebo injections~     following surgery (saline plus local anaesthetic).~      This study is significant for being the first double blind randomised control trial, using~     two PRP injections to examine the efficacy of a PRP preparation following surgical repair of~     supraspinatus tendon. The objective is to prolong and enhance the tendon healing response~     initiated by surgery.~      The research hypothesis is that enhanced tendon healing following the PRP injections will~     lead to more rapid rehabilitation and lower rates of re-rupture of the repaired tendon~     compared to the control group.~   "
164338|NCT01414751|"~     Few studies have explored how specific formats of effectiveness information effect on real~     patients' decisions. We only know little about what kind of format would be the optimal to~     help patients make well-informed real-life decisions corresponding to their preferences.~      The trial is developed in a clinical randomised design to study risk communication in the~     shared decision making between general practitioners (GP) and their patients in primary~     prevention with of cholesterol lowering drug. Endpoints are effect of GPs' information about~     treatment effectiveness and their patients' values on patients' tendency to accept and adhere~     to the treatment as well as their feeling of content with the choice made. GPs are randomised~     to inform about risk and treatment effectiveness by means of either absolute risk reduction~     (ARR) or Prolongation of Life (POL). Afterwards patients are invited to answer questionnaires~     concerning their content with decisions and reflections. Patients' redemption of~     prescriptions during the following week and the first year are recorded through an electronic~     database.~      57 GPs and 248 patients have been enrolled in the trial.~   "
164339|NCT01414738|"~     The investigators hypothesize that avoidance of the hippocampal region with WBRT may delay or~     reduce the onset, frequency, and/or severity of NCF decline, as measured with clinical~     neurocognitive tools.~   "
164340|NCT01414725|"~     The primary purpose of this study is to determine whether a 12 week Pilates based core~     stability training programme is effective in improving balance, mobility and balance~     confidence in ambulant individuals with Multiple Sclerosis (MS).~   "
164341|NCT01414712|"~     The purpose of this study is to determine if a non-invasive cancer treatment, high-dose~     stereotactic body radiotherapy (SBRT), is associated with changes in circulating tumor cells~     counts in patients with low- and intermediate-risk prostate cancer.~   "
164342|NCT01414699|"~     The purpose of this study is to determine the extent to which manipulation of dietary variety~     and course sequence affects fruit intake and overall energy intake in preschool-aged~     children.~   "
164343|NCT01414686|"~     More than half of individuals post-stroke have residual movement disabilities, including~     reduced mobility, balance, and increased risk of falling. There is a need for innovative,~     long-term and economically-feasible interventions for those with chronic stroke. Recently, a~     focus has been placed on the use of virtual reality and interactive gaming as a low cost and~     effective manner of treating movement disorders. Yet few studies have investigated~     interactive gaming platforms effect on balance following stroke. The proposed study is a~     randomized, single-blind, control group cross-over study for individuals with chronic stroke~     designed to examine an innovative therapeutic approach by investigating the effects of~     commercially-available gaming systems on balance, mobility and fear of falling in a sample of~     individuals with chronic motor deficits following stroke.~   "
164344|NCT01414673|"~     We recently reported the superiority of the natural cycle to a natural cycle controlled by~     the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed~     embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on~     endometrial receptivity.Based on the above findings we conducted the first prospective study~     that assesses whether there is a difference in pregnancy rate after intrauterine insemination~     (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise compared to natural~     cycles controlled by hCG for final ovulation.~   "
164358|NCT01414478|"~     The purpose of our study is to determine if the incidence of emesis can be lowered with the~     addition of a high protein drink during labor. Emesis and nausea are the leading causes of~     parturient dissatisfaction, results in a delay of returning to normal, daily living and can~     hugely impact the mother's postpartum experience. To date, no studies have been done on the~     relationship of protein intake during labor and incidence of emesis. To the best of our~     knowledge, the use of a high protein drink during labor has not been evaluated in the~     literature.~   "
169674|NCT01344655|"~     This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small~     airways physiological parameters in COPD patients.~   "
164345|NCT01414660|"~     Three different white adipose tissue-related disorders, whether due to its excess (obesity),~     absence (lipoatrophies) or aberrant distribution (lipodystrophies), are paradoxically able to~     induce metabolic insulin resistance syndrome. The respective roles played by quantitative and~     qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver and muscle insulin~     resistance, low-grade fat inflammation and immune alterations are not yet perfectly~     understood. In contrast to most organ transplantations that are often complicated by~     post-transplantation diabetes, diabetes cell therapy is associated with body weight loss,~     which is possibly related to the antiadipogenic effects of mTOR inhibitors (rapamycin or~     sirolimus). The aim of this study is thus to determine and monitor blood interleukin-7 and~     other cytokine levels; metabolic parameters; and fat mass distribution with DEXA and RMN,~     before and after a immunosuppressive regimen in patients receiving different kinds of~     transplantation (liver, kidney or islets) with normal weight and no type 2 diabetes before~     transplantation. In these patients, blood samples will be taken before and after~     transplantation, as will adipose tissue during the transplantation surgery, in order to~     constitute a plasma serum, gene and tissue bank for improving our knowledge of disorders~     linking fat mass, insulin resistance and immunity, especially post-transplantation diabetes.~   "
164346|NCT01414647|"~     Dietary polyphenols might have beneficial effects on glucose and lipid metabolism based on~     the studies made in animals or cell cultures. The findings regarding the possible decrease of~     low-grade inflammation are existing also in humans. Low-grade inflammation has been suggested~     to be a mechanistic link between obesity and its consequences on cardiometabolic health. The~     aim of the present study is to examine the effect of diet rich in berries on glucose and~     lipid metabolism and inflammatory markers.~   "
164347|NCT01414634|"~     Open-label, single center, phase I clinical trial to assess the safety, tolerability and~     preliminary efficacy and in vivo mechanisms of action of i.v. administration of autologous~     peripheral blood mononuclear cell (PBMC) chemically coupled with a cocktail containing seven~     immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS~     patients.~   "
164348|NCT01414621|"~     The purpose of this study is to evaluate whether angiogenesis is decreased in diabetic~     patients with coronary artery disease compared to non-diabetics with coronary artery disease.~     The protein expression of angiogenic factors will be examined in atrial tissue prior to~     initiation of cardiopulmonary bypass in patients undergoing coronary bypass surgery.~      The goal of this project is to evaluate the tissue levels of HIF-1, VEGF and angiostatin in~     diabetic and non-diabetic patients coming for on-pump coronary artery bypass graft (CABG).~   "
164349|NCT01414608|"~     This randomized phase III trial studies how well giving cisplatin and radiation therapy~     together with or without carboplatin and paclitaxel works in treating patients with cervical~     cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in~     chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop~     the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. External radiation therapy uses high-energy x~     rays to kill tumor cells. Internal radiation uses radioactive material placed directly into~     or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and~     external and internal radiation therapy together with carboplatin and paclitaxel kills more~     tumor cells.~   "
164350|NCT01414595|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research trial studies tissue samples from patients with non-small cell lung~     cancer.~   "
164351|NCT01414582|"~     This study aims to test whether repeated sessions of tDCS result in long-lasting improvements~     in motor function in patients with chronic stroke.~   "
164352|NCT01414569|"~     The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective~     as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.~   "
164353|NCT01414556|"~     Investigation of GIP effects at fasting and hypoglycemia~   "
164354|NCT01414543|"~     The objective of the proposed research is to gain a detailed understanding and account of~     psychologists' experience of client violence in clinical practice. The emphasis is upon a~     detailed understanding of how psychologists perceive and understand their experience of~     client violence and its impact upon their identity as clinicians and as individuals.~   "
164355|NCT01414530|"~     Muscle or joint pain is one of the most common symptoms during menopausal transition. As this~     could be severe enough to affect social and daily life and to reduce quality of life,~     attentions should be paid about this.~      Although understanding of muscle or joint pain related to menopause is still insufficient,~     estrogen can play an important role. Previous studies have shown that estrogen protects~     cartilage in both animals and humans.~      However, perimenopause is different from postmenopause, in the point that estrogen is still~     secreted with a great fluctuation.~      Until now, no study has been performed to evaluate the effects of oral contraceptive on~     muscle or joint pain in women during menopausal transition. Moreover, since menopausal~     symptoms vary according to ethnicity and culture, a study in Korean population is necessary.~      Therefore, this randomized controlled trial was designed to evaluate the effects of oral~     contraceptive on muscle or joint pain in women during menopausal transition, compared to~     NSAID (non-steroidal anti-inflammatory drug).~   "
164356|NCT01414517|"~     The study will consist of pair of double-blind placebo-controlled trials of dietary~     supplementation with 15g/day FructoOligoSaccharide (FOS) for 7.5 weeks in patients with~     prostate carcinoma or 5 weeks in patients with cervical or endometrial carcinoma who are to~     undergo pelvic radiotherapy with intent to cure.~   "
164359|NCT01414465|"~     Orlistat is a popular drug approved for long-term use which produces weight loss by~     inhibiting triglycerides, main components of fats in the diet and reducing dietary fat~     absorption by up to 30%. The effect of this drug on human blood fatty acid profile has not~     been described yet. The FA composition of RBCs, plasma and platelets can be used to monitor~     of many pathological processes. This study presents alteration of FA composition in RBCM and~     phospholipids, triglycerides and cholesteryl esters from plasma of health obese female~     volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.~   "
169675|NCT01344642|"~     The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA in~     saliva.~   "
164360|NCT01414452|"~     There is experimental evidence that low levels of adiponectin are associated with more~     reperfusion injury. In addition experimental studies have demonstrated that endothelial~     progenitor cells may have a favorable effect on remodeling, mainly through stimulation of~     neo-revascularisation. Clinical data on these issues are lacking. This clinical project~     studies the role of adiponectin, endothelial progenitor cells and endothelial microparticles~     in the ischaemia-reperfusion process and the compensatory ventricular remodelling in a~     population of 250 infarction patients treated with primary PCI. If the role of these factors~     could be confirmed in this clinical setting, those factors might represent a new target for~     therapeutic interventions in AMI patients.~   "
164361|NCT01414439|"~     This study will examine the efficacy of group therapy utilizing the Existential Approach in~     heart failure patients when compared to a control group of patients who are waiting for the~     same group treatment. This comparison will be achieved by measuring changes in the variables~     studied namely, the levels of psychological distress and levels of psycho-social adjustment.~   "
164362|NCT01414426|"~     This randomized phase II trial studies how well vandetanib works in preventing head and neck~     cancer in patients with precancerous head and neck lesions. Chemoprevention is the use of~     certain drugs to keep cancer from forming. The use of vandetanib may keep cancer from forming~     in patients with premalignant lesions~   "
164363|NCT01414413|"~     Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence~     countries, the majority of people with HIV infection still initiate treatment at an advanced~     stage of disease. This leads to a high risk of death soon after HIV diagnosis. Prompt HIV~     diagnosis is, therefore, necessary for both individual and public health benefit and is being~     strongly promoted as international and national policy in Malawi. However timely HIV~     diagnosis may not in itself be sufficient to ensure ART initiation: this is reflected by the~     relatively high proportion of individuals who defer treatment-seeking for months or years~     following diagnosis of HIV.~      Here the researchers investigate the extent to which home assessment and initiation of ART~     adds to the effectiveness of a home-based HIV testing and counseling strategy, using entry~     to, adherence with, and retention in HIV care as the outcome of interest.~   "
164364|NCT01414400|"~     The aim of this study is to prospectively evaluate the frequency of bacteremia after~     ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the~     frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.~   "
164365|NCT01414387|"~     Carotid artery stenting (CAS) with cerebral embolic protection is the preferred treatment for~     narrowing of the carotid arteries in patients at high risk for open surgery. Special devices~     are used to protect the brain from particles(emboli) that may break off when the narrowing or~     blockage is cleared during the angioplasty and stenting procedure. Although filters are most~     frequently used, protection systems consisting of balloons and flow reversal are also~     available for cerebral embolic protection. However, there is little information about the~     effectiveness of filters compared with balloons and flow reversal for prevention of~     embolization during CAS. The aim of our study is to address this major problem. Our study was~     designed to answer two specific questions: First, the study will investigate whether~     balloon-based protection systems are more effective than filters in reducing the amount of~     particles that break off and travel to the brain during CAS. For this purpose two imaging~     techniques will be used: magnetic resonance imaging of the brain (MRI), and transcranial~     doppler (detection of microparticles in the small brain vessels using ultrasound). Second, it~     will be investigated whether the use of balloon-based protection devices are more effective~     than filters for prevention of stroke, heart attacks, and death after carotid stenting. The~     results of the study will provide important information to find out the best way to protect~     the brain from plaque fragments that may break off during CAS.~   "
164366|NCT01414374|"~     The study aims to investigate the prevalence of genetic polymorphisms in adults with iron~     deficiency and anemia, and the responses to two different treatments: iron sulphate and a~     composite herbal medicine (Hibiscus sabdariffa plus Centella asiatica). The main outcome will~     be hemoglobin, measured before and after 6 weeks.~   "
164367|NCT01414361|"~     Recent studies have shown that optimal IVUS criteria defining the functional significance~     (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of~     the coronary tree. Herein, the investigators performed this study to validate these results~     and to generalize the IVUS criteria defining functional significance of intermediate coronary~     stenosis in a different location of coronary tree in a larger sample size.~   "
164368|NCT01414348|"~     Successful community participation following acquired brain injury (ABI) continues to be an~     elusive goal for patients, clinicians and researchers. Our pilot work shows that community~     dwelling survivors of ABI can significantly improve performance on self-identified real-~     world performance problems and that they can transfer this learning to improve goals not~     trained in the treatment sessions. We will compare two types of rehabilitation intervention~     using a randomized controlled trial. We will also interview survivors, their significant~     others and clinicians regarding their experiences with each intervention to help us discover~     what works best.~   "
164369|NCT01414335|"~     The purpose of this study is to investigate the effectiveness of a dietary supplement with~     high dosage of amino acids and vitamins in the treatment of acute and chronic infection of~     pharyngeal area known as common cold. T~   "
164370|NCT01414322|"~     Phenotype characterization of shortness of breath of pediatric emergency room patients by~     objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy~     and correlates with overall patient outcomes.~   "
164371|NCT01414309|"~     Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs~     in patients with heart failure (HF). The primary purpose of this study is to document the~     natural progression of moderate to severe CSA in heart failure patients.~   "
164372|NCT01414296|"~     Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301EXT is an~     open-label, nonrandomized, phase 1 extension study of PSMA ADC administered IV in subjects~     with progressive CMPC that has progressed after prior taxane therapy. Subjects who have~     participated in PSMA ADC 1301 and who, in the opinion of the PI, are likely to benefit from~     continued treatment with PSMA ADC will be enrolled in PSMA ADC 1301EXT.~   "
164374|NCT01414257|"~     This Investigation is to be performed for the purpose of assessing the following information~     in the long-term post-marketing daily medical practice in the patients who receive REUMATOLEX~     2 mg Capsule for the treatment of Rheumatoid Arthritis (RA) at the dose higher than 8~     mg/week.~        1. Condition of occurrence of ADRs~        2. Factors considered to affect safety~        3. Verification of efficacy~   "
164375|NCT01414244|"~     New and effective treatments are needed for patients with post-infectious irritable bowel~     syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy~     and safety of glutamine, an abundant amino acid in the body and the principal fuel for~     enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with~     increased intestinal permeability following an enteric infection.~   "
164376|NCT01414231|"~     This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is~     compared to the common German standard arm after randomization in a 9:1 ratio. The hypothesis~     involves primarily dosing and application of AraC for induction. It is expected that CR rates~     and as a consequence also LFS are higher in protocols using higher AraC compared to lower~     doses and that LFS might be superior in the study specific arm compared to the golden~     standard published several years ago. In the standard arm, AraC 100mg/m2/day is given as~     continuous infusion over 7 days. Daunorubicin is given as 60 mg/m2/day over a two hours~     infusion on days 3, 4 und 5. On day 22 a second induction course is applied. After reaching~     CR, three cycles of AraC 3 g/m2 over three hours bid are infused on day 1, 3 und 5. In~     contrast the OSHO arm consists of induction therapy with IDA 12 mg/m*2 over 20-30-min-iv on~     day 1 - 3 and AraC 2 x 1 g/m*2 bid over 3-h-iv on days 1+3+5+7.~      A previous phase II study of the OSHO has shown high CR in patients with relapsed AML using~     MitoFlag. In this study we asked the question if MitoFlag is superior to IdaAraC in newly~     diagnosed AML patients without CR after the first induction chemotherapy. Therefore patients~     are randomized to receive either MitoFlag or IdaAraC and the difference in CR rates~     evaluated.~      It is still unclear if two consolidation therapies are needed before allogeneic or autologous~     stem cell transplantation. This question is being addressed in the second part of the OSHO~     study, where patients are randomized to receive either one or two consolidation therapies.~      In this study all patients with AML and an age of 18-60 years except M3 are entered~   "
164377|NCT01414218|"~     1. Senior citizens living in the community who participate in a humor seminar will have~          improved health quality of life compared to those not participating in the seminar.~        2. Senior citizens living in the community who participate in a humor seminar will have~          improved general well being compared to those not participating in the seminar~        3. Senior citizens living in the community who participate in a humor seminar will have~          decreased psychological distress compared to those not participating in the seminar~   "
164378|NCT01414205|"~     This open-label, multicenter, randomized study compared the efficacy, safety and~     pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants~     with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles~     (28-day cycle) of obinutuzumab (1000 mg intravenous [IV] infusion, on Days 1, 8 and 15 of~     Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of~     obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each~     subsequent cycle up to 8 cycles.~   "
164379|NCT01414192|"~     This study is being done to provide valid data on the evolution of a cohort of French~     participants treated with ezetimibe, alone or in combination with a statin, to be used in~     simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk~     factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density~     lipoprotein cholesterol (LDL-C) levels over time will be analyzed.~   "
164380|NCT01414179|"~     Introduction. The cardiovascular diseases, at the origin of 4 deaths out of 10, remain the~     leading cause of mortality in Europe. According to WHO, this tendency will spread in 2020 on~     a worldwide scale. These pathologies are avoidable on the whole by the adoption of healthy~     lifestyles. To prevent occurred of the cardiovascular affections is, more than ever, a major~     goal of Public health. The transborder Great Area, localised zone in the middle of Europe~     between the very high cardiovascular risks of the North and the weaker risks of the South,~     constitutes a zone privileged for the action against the cardiovascular diseases. However,~     there to date does not exist any joint action in this geographical area. The Public Research~     centre of the Health of the Grand-Duchy of Luxembourg, the School of Public health of the~     University of Liege, the Clinical Center of Investigation of the University hospital of Nancy~     and the University hospital of the Saar wish to be linked and mutualiser their means~     available and their complementary competences in order to evaluate and to act on the~     cardiovascular health of the citizens of the Great Area. Over one 3 years period the~     Nutrition project, Environment and Cardiovascular Health (NESCAV) aims at creating on the~     level of the Great Area a transborder alliance of prevention and promotion of cardiovascular~     health. This great multicentric transverse investigation and poly-set of themes will make it~     possible to collect relevant data on cardiovascular health of the population of the Great~     area.~      Objective of this biomedical research project: It is about multicentric, transverse a~     Européenne epidemiological study aiming, through biological questionnaires and analyses, to~     collect information on the cardiovascular risk factors within the Great Area.~   "
164381|NCT01414166|"~     The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination~     tablets in a primary prevention population currently not taking or eligible for~     lipid-modifying therapy (LMT); the population will comprise participants with low to moderate~     risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low~     density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated~     triglyceride (TG) levels.~   "
164404|NCT01413815|"~     The aim of the study is to test whether pre-operative oral supplementation with L-arginine~     results in a significant reduction of peri-operative cardiovascular complication rate in~     unselected patients undergoing major abdominal or thoracic (non-cardiac) surgery. The second~     aim of the study is to assess whether pre-operative determination of plasma ADMA levels~     allows to identify patients who are at high risk of experiencing a peri-operative~     complication, and whether this subgroup of patients profits specifically from pre-operative~     L-arginine supplementation.~   "
193813|NCT01026662|"~     This study will:~      Evaluate the in vivo effects of treatment with eMatrixCO2 and to determine the dynamics of~     their development over time following treatment.~   "
164382|NCT01414153|"~     The purpose of the study is to determine the safety and efficacy of 4 monthly injections of~     iSONEP given alone or in combination with Lucentis, Avastin or Eylea in subjects with wet~     Age-related Macular Degeneration (AMD). iSONEP not only has an anti-permeability effect, but~     also has anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. The drug may~     therefore have the ability to achieve better visual outcomes than Lucentis, Avastin or Eylea,~     particularly in those subjects who do not demonstrate a robust response to Lucentis, Avastin~     or Eylea after several monthly injections. Further, the combination of Lucentis, Avastin or~     Eylea and iSONEP may be additive or synergistic. By inhibiting the multiple mechanisms that~     contribute to exudative-AMD-related vision loss, better visual outcomes may be possible than~     with Lucentis, Avastin or Eylea alone.~   "
164383|NCT01414140|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of women who are inserted Mirena for intrauterine~     contraception. The objective of this study is to assess safety and effectiveness of Mirena~     under real-life practice conditions. A total 550 patients will be recruited and followed for~     5 years.~   "
164384|NCT01414114|"~     The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV)~     administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in~     hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).~   "
164385|NCT01414101|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     ISIS CRP Rx and its effects on CRP and other pharmacodynamic measures, versus placebo, in~     subjects with active rheumatoid arthritis.~   "
164386|NCT01414088|"~     The kidneys have numerous salt and water channels and play a major role in the regulation of~     sodium and water. We do not know how these channels work in certain water and sodium~     accumulating medical conditions.~      The purpose of this study is to identify and measure the activity in the water and sodium~     channels by measuring urine biomarkers/proteins in young healthy subjects.~   "
164387|NCT01414075|"~     The purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of~     anemia in patients with end-stage renal disease who recently started dialysis.~   "
164388|NCT01414062|"~     Hispanic women are 20% more likely to die of breast cancer than non Hispanic white women who~     are diagnosed at a similar age and stage. One reason for this disparity may be differences in~     post diagnosis dietary behaviors. In order to reduce this disparity, and to improve overall~     survivorship, culturally appropriate dietary interventions that teach women how to eat a diet~     high in fruits and vegetables and low in saturated fat need to be developed for Hispanic~     breast cancer survivors. The investigators propose to conduct a randomized controlled study~     (n=70, 35 per arm) to test the effects of the ¡Cocinar para su salud! program on changing~     dietary behaviors among Hispanic breast cancer survivors who have recently completed~     treatment. The ¡Cocinar para su salud! program is a 12 week course that provides hands on~     education and instruction in nutrition education, meal preparation, and food shopping in a~     group setting. All participants will be followed for a total of 12 months, have clinical~     assessments at baseline, 6 months, and 12 months, and monthly telephone contacts using~     motivational interview techniques. The Primary Aims are to determine the effect of the~     dietary intervention (¡Cocinar para su salud! program) vs. control (standard written~     nutrition education materials for cancer survivors) on 1) daily servings of fruit/vegetable,~     and 2) daily servings of fat intake from baseline to 6 months. The investigators hypothesize~     that the dietary intervention will result in a larger increase of fruit and vegetable intake~     and a larger reduction of fat intake, when compared to the control group. Secondary Aims are~     to determine the effect of the dietary intervention vs. control on 1) biomarkers of fruit and~     vegetable intake, molecular biomarkers associated with breast cancer risk, and anthropometric~     measures at 6 and 12 months; 2) fruit/vegetable and fat intake at 12 months; 3) mediators of~     dietary change, including readiness to change, outcome expectations, perceived self efficacy,~     food and nutrition skills, self regulation skills, and barriers to adherence; and 4) changes~     in quality of life and anxiety/depression at 6 and 12 months.~   "
164389|NCT01414049|"~     Heart bypass surgery is used to increase blood flow to the heart. This surgery is usually~     done using a heart-lung machine (on-pump surgery) allowing the surgeon to perform the~     procedure on a still heart. However, this heart-lung machine causes an inflammatory response~     and is linked with complications such as heart injury, stroke, brain injury, kidney failure,~     need for blood transfusions, irregular heart rhythms and death. An effective way of~     counteracting the effects of the heart-lung machine is to not use the pump itself, thus~     performing the bypass surgery with a beating heart (off-pump surgery). However, off-pump~     surgery is technically more difficult, possibly associated with a decrease in graft patency.~     The ongoing Coronary Artery Bypass Graft Off or On Pump Revascularization Study (CORONARY),~     is a prospective randomized clinical trial comparing bypass surgery done with and without the~     pump. Worldwide, 4700 patients will be included and followed up for 5 years. The proposed~     research project, The Patency AssessmenT of grafts pErformed iN CORONARY (PATENCY-CORONARY),~     is a prospective clinical trial for the evaluation of patency (or openness) of the bypass~     grafts that will enrol 1200 consecutive CORONARY patients reaching their one year follow-up.~     Patients will undergo a non-invasive scan using X-rays to safely and quickly evaluate graft~     patency. The PATENCY-CORONARY trial will determine if off-pump surgery is associated with~     decreased graft patency at 1-year post-surgery compared to on-pump surgery when performed by~     skilled surgeons in different clinical settings, whether decreased graft patency is~     associated with adverse short and long-term outcomes, and explore other risk factors~     associated with decreased graft patency.~   "
164390|NCT01414036|"~     Cigarette smoking is a highly significant health threat, responsible for more than 430,000~     deaths each year. Low-income persons and racial/ethnic minorities are at particularly high~     risk, smoking at greater rates and having greater tobacco-related morbidity and mortality~     than other persons. Yet poor and minority smokers are less likely to receive advice to stop~     smoking or to use tobacco cessation services. Using non-physician members of the health care~     team as patient navigators to connect low-income and minority smokers to evidence-based~     tobacco treatment services is a promising approach because 1) many primary care providers~     (PCPs) are unable to provide counseling to patients who smoke due to time constraints; 2)~     minority patients may be less aware of smoking cessation resources and may have~     misconceptions about tobacco dependence treatments; and 3) as primary care practices are~     redesigned as medical homes, non-physician members of the health care team will increasingly~     be taking on tasks previously performed by PCPs. Patient navigators are lay persons from the~     community, working as paid employees, who are trained to guide patients through the health~     care system to receive services. Information on the efficacy of patient navigation to connect~     vulnerable patients to smoking cessation services is needed.~      The investigators will implement a patient navigation-based intervention in the primary care~     setting to promote engagement of low-income and minority patients in smoking cessation~     treatment. To test our intervention, the investigators will conduct a pilot randomized~     control trial (RCT), randomizing 240 patients to the intervention condition (patient~     navigation) or an enhanced traditional care (ETC) control condition. The investigators will~     perform follow-up at three months following the start of the intervention, with a primary~     outcome of engagement in smoking cessation treatment.~   "
164453|NCT01413178|"~     The goal of this clinical research study is to compare Busulfex (busulfan) with or without~     Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in~     patients who will receive an autologous stem cell transplant. The safety of this combination~     therapy will also be studied.~      Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may~     cause cancer cells to die.~   "
164391|NCT01414023|"~     This experiment will examine if the use of computerized tasks that train individuals to~     control their attention more effectively will predict individual differences in~     obsessive-compulsive symptoms, rumination and BDNF change. After giving consent, filling out~     self-report forms, and giving blood for the BDNF test, 80 participants will be randomized to~     Cognitive Control Training (CCT) or Peripheral Vision Task (PVT) (described below) which will~     be administered three times over a two week period. At the third visit, participants will~     also complete an anagram task and repeat the blood draw for BDNF testing. The investigators~     hypothesize that computerized tasks that train individuals to control their attention more~     effectively will reduce Obsessive Compulsive (OC) symptoms. Additionally, individuals~     training in CCT will show increased ability to disengage from unattainable goals as assessed~     by responses to an unsolvable anagram task. Finally, individuals training in CCT will show a~     greater increase in BDNF levels as compared to individuals training in PVT.~   "
164392|NCT01414010|"~     The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes~     Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut~     microbiota of healthy volunteers. It is expected that treatment will result in the rapid and~     reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks~     after treatment is discontinued.~   "
164393|NCT01413997|"~     The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure~     (CTMM) -quantifying the functional behavior of perimuscular connective tissues.~   "
164394|NCT01413984|"~     The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma~     (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft,~     Oklahoma. The purpose of the proposed study is to expand previous findings by including a~     comparison group of women that are not receiving treatment but are otherwise eligible, and by~     using outside evaluators to conduct the assessments. Furthermore, this study will extend the~     outcomes measured in previous evaluations by including measures of sleep disturbance,~     posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The~     hypotheses for this study are listed below:~        1. Incarcerated women with substance use disorders and history of trauma enrolled in the~          integrated treatment program (HWR plus BT) will report significantly fewer symptoms on~          measures of posttraumatic stress and associated cognitions, substance use, depression,~          and related symptoms following treatment than those in the comparison group.~        2. Those in the treatment group will improve significantly more than those in the~          comparison group on the symptoms listed above.~   "
164395|NCT01413958|"~     This study will compare the nasal congestion symptom relief of phenylephrine extended release~     tablets and placebo in participants with allergic rhinitis.~   "
164396|NCT01413945|"~     The aim of the current study is to test the hypothesis that patients with IBS may have a~     defective ICV pressures and may have small bowel bacterial overgrowth. The goal of the~     current study is to identify the role and competence of ileocecal valve (ICV) in patients~     with irritable bowel syndrome.~      The primary objective is to measure the pressure of the ileocecal valve in patients with and~     without irritable bowel syndrome (IBS). The Ileocecal valve reflux pressures during air~     insufflation of cecum will be used.~   "
164397|NCT01413932|"~     This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability,~     and pharmacokinetics of HT-2157 in healthy normal volunteers~      Part 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose~     evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in~     patients with major depressive disorder~   "
164398|NCT01413906|"~     The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923~     (XL139) when orally administered on a once daily schedule.~   "
164399|NCT01413893|"~     An extension study of linifanib in subjects with advanced or metastatic solid tumors.~   "
164400|NCT01413867|"~     Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of~     less postoperative pain compared with excisional surgery, however a still relevant percentage~     of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler~     device has been designed to overcome these drawbacks by modifying the stapled sutures and by~     increasing the space for mucosal resection in the case of the stapler.~      This randomized controlled study was aimed to demonstrate whether the new EEA stapler~     Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03~     Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if~     the modified stapled sutures can ensure better intraoperative hemostasis by measuring the~     number of overstitches required to get perfect hemostasis during the operation.~   "
164401|NCT01413854|"~     The purpose of this study is to determine whether diclofenac is effective in the treatment of~     depressed patients with a recent suicide attempt.~   "
164402|NCT01413841|"~     Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary~     Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this.~     In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent~     Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with~     acute myocardial infarction (with normal blood saturation. The investigators therefore wanted~     to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.~   "
164403|NCT01413828|"~     Most of the published data support the preferential use of an anthracycline-containing~     adjuvant regimen for individuals with HER2-positive tumors. Concurrent anthracyclines and~     trastuzumab, however, are contraindicated due to the observation of unacceptably high rates~     of cardiotoxicity in a large randomized trial in the metastatic setting. However, in~     neoadjuvant setting, trastuzumab concurrently with an anthracycline-containing chemotherapy~     regimen had shown high pathological complete response (pCR) and very low cardiotoxicity. All~     large adjuvant trials have evaluated only the sequential strategy of administering~     anthracyclines and trastuzumab. The safety and efficacy of trastuzumab concurrently with an~     anthracycline-containing chemotherapy regimen has never been evaluated in adjuvant setting.~     Given the similar patients characteristics, the investigators hypothesize that trastuzumab~     concurrently with an anthracycline-containing chemotherapy regimen would not increase~     cardiotoxicity but efficacy.~   "
164462|NCT01413048|"~     The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in~     patient with stage 1 to 2 essential hypertension.~   "
164405|NCT01413802|"~     During thyroid surgery the laryngeal recurrent nerves (and for this reason the voice quality)~     are at risk. Therefore intra operative continuous neuromonitoring could help to prevent harm~     to these nerves. Electromyographic data (EMG values) are collected during surgery (1). In the~     postoperative follow-up period detailed voice analysis is performed (2): subjective auditive~     perceptive evaluation and videostroboscopy. Analysis and comparison of (1) and (2) will be~     performed in order to find out if we can find a predictive correlation between the EMG data~     (1) and the voice quality (2).~   "
164406|NCT01413789|"~     Study hypothesis: Is Alhydran gel-cream as efficient as silicone gel for skin occlusion and~     hydration?~      For this study 16 volunteers and ten patients with healed full thickness burns will be~     included.~      After a short period of acclimatization four test areas will be determined. For healthy~     volunteers the standard zones are located on the inner forearm, two on each forearm.~      For patients with healed burns the 4 test zones are located on either the healed donor site~     or the healed skin grafted area.~      In each test zone baseline measurements will be taken before application of the~     products.After application of the three silicone gels and the hydrating gel cream the trans~     epidermal water loss (TEWL) and the moisture content of the stratum corneum will be measured~     by using the TEWAmeter®TM300 and the Corneometer® CM825 (Courage & Khazaka).~   "
164407|NCT01413776|"~     The study will evaluate the effects of a nutrition supplement for pregnant women on birth~     weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified~     food supplement will produce babies with a higher mean birth weight than those who do not.~   "
164408|NCT01413763|"~     The purpose of this study is to determine the potential effect of topically applied 3.75%~     imiquimod cream on atrial ectopy in actinic keratosis (AK) patients. The primary endpoint is~     the change in the 24-hour supraventricular premature beat count. The secondary endpoint is~     the change in 24-hour supraventricular premature couplet and run counts and atrial~     fibrillation (% time); change in 24-hour mean heart rate; change in 24-hour ventricular~     premature beat count, ventricular premature couplet and run counts.~   "
164409|NCT01413750|"~     Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether giving carboplatin and paclitaxel~     together is more effective with or without vorinostat in treating non-small cell lung cancer.~   "
164410|NCT01413737|"~     This is a retrospective, descriptive analysis of (1) 30 day postoperative results of surgery~     for lung cancer, (2) 30 day outcome predictors - compared to an earlier similar study in the~     same hospital (St Olav University Hospital, Trondheim, Norway).~   "
164411|NCT01413724|"~     The study is a national survey of pain and pain management to surgical patients in Norwegian~     Hospitals. Data on pain management are gathered from patient records and data on pain and~     patient satisfaction are gathered as patients' self report.~   "
164412|NCT01413711|"~     The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in~     neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of~     vigabatrin.~   "
164413|NCT01413698|"~     People with respiratory infection, asthmatic patients and cystic fibrosis (CF) patients~     suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.~      Treatment of cough in these patients consists of many types of expectorants, cough~     suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical~     therapy (PT) is often prescribed as part of the treatment regime.~      The assessment of coughing is currently subjective and based on the symptoms qualitative~     description as expressed by the patient or parent. Quantitative and objective methods for~     cough assessment are not available beyond the investigative laboratory and are unique to the~     specific investigator.~   "
164414|NCT01413685|"~     The purpose is to define if calcineurin activity is a better biological parameter than blood~     concentration for the therapeutic tacrolimus monitoring.~   "
164415|NCT01413672|"~     The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin~     environment will result in reduced peristomal skin irritation.~   "
164416|NCT01413659|"~     The objective of the study is to investigate whether peri-operative symbiotic treatment could~     reduce the risk of postoperative infections in patients undergoing elective colorectal~     surgery. This study was also designed to assess the risk-adjusted incidence and predictors of~     surgical site infections.~   "
164417|NCT01413646|"~     The purpose of this study is to examine the effects of walnut consumption on endothelial~     function and lipid markers in overweight patients with at least one factor of metabolic~     syndrome as compared to the control group.~   "
164418|NCT01413633|"~     The investigators describe a novel technique for GB fundus retraction.~   "
164419|NCT01413620|"~     Burned patients because of their increased oxidative stress have severely depleted vitamin E,~     which is a dietary antioxidant. Oxidative stress is responsible for much of the~     pathophysiology seen in burned patients, which leads to acute and chronic morbidity and~     mortality, in addition to a decrease in their quality of life. Oral vitamin E will be used to~     reverse the oxidative stress of burn injury and, in the process, decrease the secondary~     consequences of thermal trauma. This proposal will demonstrate the benefit of maintaining~     adequate vitamin E status.~   "
164420|NCT01413607|"~     The objective of this study is to assess whether using a different type of suture (barbed~     sutures) during partial nephrectomy results in fewer postoperative complications than with~     traditional sutures (non-barbed). The most common complications are urine leakage and~     bleeding. The investigators believe the barbed suture is less technically difficult to use~     and will allow the surgeon to better repair the hole left in the kidney after the tumor is~     removed.~   "
164421|NCT01413594|"~     A randomized control trial of bimanual training in children with hemiplegia. The protocols~     have been developed at Columbia University to be child friendly and draws upon our experience~     since 1997 with constraint-induced movement therapy in children with cerebral palsy. The~     investigators will test the hypothesis that bimanual training (HABIT) will result in improved~     hand function in children with hemiplegia.~   "
164422|NCT01413581|"~     The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as~     compared with placebo.~   "
164423|NCT01413568|"~     Determine the safety and tolerability of POL6326 when used as a single mobilization agent.~   "
164424|NCT01413555|"~     False positive blood culture results due to specimen contamination with bacteria inhabiting~     patients' skin is a common problem in emergency departments (EDs) in the United States.~     Contaminated blood cultures lead to patient harm through unnecessary hospitalizations and ED~     visits, delays in surgery, unneeded antibiotics, and unnecessary procedures. The~     investigators have developed a multifaceted quality improvement improvement bundle (The Blood~     Culture QI Program) designed to minimize blood culture contamination in the ED. In this~     study, the investigators will implement the quality improvement bundle in six community~     hospital EDs and evaluate its effectiveness at reducing contamination.~   "
164425|NCT01413542|"~     The investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or DPP4~     inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people~     receiving enalapril (angiotensin converting enzyme or ACE inhibition), a blood pressure~     medicine. Understanding how these drugs interact in healthy people will help us learn their~     potential effects in people who have diabetes.~   "
164426|NCT01413529|"~     HIV infected drug users have greater difficulty adhering to highly active antiretroviral~     therapy compared to non-drug users. As sustained adherence to highly active antiretroviral~     therapy is critical to reducing HIV related morbidity, mortality, and reducing the spread of~     HIV, innovative and potentially sustainable treatment strategies that can optimize the~     durability of adherence enhancing interventions among drug users is urgently needed. The goal~     of this study is to further develop and pilot test a smartphone based intervention called~     HEART (Helping Enhance Adherence to Retroviral therapy using Technology) to HAART, to enhance~     adherence to HAART among HIV infected drug users.~   "
164427|NCT01413516|"~     This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study~     that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr)~     smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).~   "
164428|NCT01413503|"~     This is an ongoing prospective Phase II clinical trial evaluating the efficacy of 131I-MIBG~     for the treatment of patients with metastatic or unresectable pheochromocytoma and related~     tumors.~   "
164429|NCT01413490|"~     Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide.~     Current treatment of hepatitis C infection is only successful in about half of those who are~     eligible. The current treatment aims to boost the host immune system but does not directly~     act on the virus. Many drugs are in various stages of development that target the virus~     directly - their specific mode of action is confirmed by showing the virus is forced to adapt~     in the presence of the drug. As with many viruses, treating with only one specific drug would~     quickly lead to the virus adapting and becoming resistant. We therefore need to find new~     combinations of directly acting drugs. Rimantadine has already been shown in the laboratory~     to target hepatitis C directly. We have designed this study to see if it happens in real life~     as well. If so, we could use rimantadine to help fight hepatitis c more effectively.~   "
164430|NCT01413477|"~     Nickel contact dermatitis (eczema) is one of the most common allergic conditions affecting~     the skin. This is a study looking at potentially desensitizing nickel-allergic patients to~     their allergy using anti-inflammatory ointments applied to the skin (arm). Application of~     these ointments (ie. modified Vitamin D) has been shown to increase specific immune cells (T~     regulatory cells), which play a role in preventing immune activation and subsequently~     inflammation. The investigators propose use of topical anti-inflammatory agents~     (corticosteroids, modified Vitamin D, or both) may desensitize patients with nickel allergy.~   "
164431|NCT01413464|"~     Clots that develop in the deep veins of the legs or the lungs can result in pain, heart and~     lung disease and may lead to death if unrecognized or not treated. Risk factors for~     developing clots include surgery, hospitalization and/or being immobile. Up to 10 to 40% of~     people may develop a clot during or after their hospital stay or surgery, and sometimes these~     clots do not cause symptoms. In order to help reduce the risk of developing a clot in the~     legs or lungs, many people undergoing surgery receive a small dose of a blood thinner in~     hospital after their surgery is completed. Although prescription of a low dose blood thinner~     is routine practice after most surgeries, the risk or benefit of blood thinners after kidney~     transplant surgery is still not clear. Given this, many transplant physicians differ in~     prescribing practices of low dose blood thinners after kidney transplant surgery. More~     information is needed about the risk of clotting and bleeding in people after kidney~     transplant surgery so that physicians can become more unified in deciding whether a low dose~     blood thinner would protect patients after kidney transplant without producing harm.~      The REPORT study is designed to examine the risk of clotting in the legs or lungs in people~     after kidney transplant surgery as well as the risk of bleeding. Ultrasounds of the legs will~     be performed at various time points after surgery for up to one year to screen for blood~     clots. People participating in this study will also be screened and monitored for bleeding~     after surgery. Although this study will also examine the prescription practices of~     physicians, no blood thinners will be given or withheld from participants as a result of this~     study. Physicians will prescribe blood thinners as per their usual practice after kidney~     transplant. Overall, the goal of the study is to find out how frequent clotting and/or~     bleeding is after kidney transplant surgery, which will help in making recommendations~     regarding the use of low dose blood thinners in people after their surgery.~      Ultrasound scanning of the legs is a safe test that does not cause physical pain and has no~     risk of causing injury. Participation in this study will provide the benefit of additional~     monitoring with several ultrasound tests after surgery, screening for clots in the legs which~     can cause health risks and even death if unrecognized. If a clot is found, it will be treated~     promptly and according to current medical standards under the care of a specialist.~      In the long term, the results of this study will help improve health care delivery to people~     undergoing kidney transplant with the goal of decreasing potential complications such as~     clotting and/or bleeding. Currently, there are no guidelines available to guide physician's~     in the use of a low dose blood thinner after kidney transplant surgery. This study will help~     determine the risk of clotting or bleeding and help us make recommendations that will reduce~     potential risks and complications for people undergoing kidney transplant in the future.~   "
164432|NCT01413451|"~     Background:~      - Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this~     substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab~     helps the immune system to kill cells that have high levels of mesothelin. However, more~     research is needed to determine how safe and effective amatuximab is for treating tumors with~     high levels of mesothelin.~      Objectives:~      - To assess the safety and effectiveness of amatuximab in treating tumors with high levels of~     mesothelin.~      Eligibility:~      - Individuals at least 18 years of age who have a type of cancer that overexpresses~     mesothelin.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests and tumor assessment studies.~        -  Participants will have two intravenous doses of amatuximab several hours apart.~          Researchers will monitor them closely and do frequent blood draws. On the same day and~          also within 48 hours of the second dose, participants will have imaging studies. These~          studies will measure how well the amatuximab is working against the cancer.~        -  Participants will have a third imaging study of the cancer about 1 week after the~          infusions.~        -  Participants will have a followup visit 2 weeks after receiving amatuximab. This visit~          will require blood samples. Four weeks after receiving the drug, researchers will review~          patients symptoms or side effects. This interview can be done in person or by phone.~   "
164463|NCT01413035|"~     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells~     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg for type 2~     diabetes.~   "
164433|NCT01413438|"~     Background:~      - Glioblastoma (GBM) is the most common malignant brain tumor in adults. Patients with GBM~     are usually treated with surgery, radiation, and chemotherapy. Despite this treatment, most~     GBMs start growing again. Bevacizumab, a chemotherapy drug, has shown promise in slowing the~     growth of GBMs. More research is needed to find out whether having surgery before starting~     bevacizumab is more effective than bevacizumab alone.~      Objectives:~      - To compare surgery plus bevacizumab to bevacizumab alone in adults with glioblastoma.~      Eligibility:~      - Individuals at least 18 years old whose glioblastoma has come back after treatment.~      Design:~        -  All participants will be screened with a physical exam, medical history, blood tests,~          and imaging studies.~        -  Participants will be divided into two groups. One group will have surgery followed by~          bevacizumab. The other group will have the drug without surgery.~        -  The first group will have surgery as soon as possible and will begin bevacizumab 4 weeks~          after surgery. The second group will start the drug as soon as possible.~        -  Both groups will receive the drug as an infusion every 2 weeks. They will be monitored~          with frequent blood tests and imaging studies. The infusions will continue for as long~          as the drug is effective at preventing tumor regrowth.~        -  Participants will be contacted every 4 weeks after they stop taking bevacizumab. They~          will answer followup questions either in person or by telephone.~   "
164434|NCT01413425|"~     Background:~      - Smith-Lemli-Opitz syndrome (SLOS) is a genetic disorder that prevents the body from making~     enough cholesterol. People who have SLOS often need to take extra cholesterol, either in food~     or in supplements, for their bodies to work properly. Cholesterol is very important for the~     brain and nervous system. Therefore SLOS is highly related to autism, mental retardation, and~     other brain and nervous system disorders. Not much is known about how people with SLOS handle~     cholesterol and how taking extra cholesterol helps them. A long-term study of people with~     SLOS will help answer these and other questions.~      Objectives:~      - To study the effects of a high-cholesterol diet on people with Smith-Lemli-Opitz syndrome.~      Eligibility:~      - Individuals of any age who have Smith-Lemli-Opitz syndrome.~      Design:~        -  Participants will have study visits up to two times in the first year and once a year~          every year after that. Each visit will last between 3 and 5 days.~        -  Participants will be screened with a physical exam, medical history, and blood and urine~          tests.~        -  Participants will provide regular blood, urine, stool, saliva, and skin cell samples for~          testing.~        -  Participants will keep track of the foods they eat at home. During the study, they will~          eat a high-cholesterol diet at all times, except for the second study visit (3 to 6~          months after the screening visit). That visit will involve a cholesterol-free diet for 4~          weeks.~        -  Participants will have special cholesterol tests with blood samples at different times~          during the study.~        -  At different study visits, participants will have tests of mental and physical skills~          (including tests for autism). They will answer questions about their diet and food~          habits. They will also have hearing and eye tests, body and bone measurements, and~          imaging studies. Not all of the tests will be done at every study.~        -  Participants will be allowed to leave the study at any time.~   "
164435|NCT01413412|"~     This is a prospective randomized study to compare surgical methods for the repair of large~     abdominal hernia.~   "
164436|NCT01413399|"~     The objective of this study will be to assess the frequency of return of spontaneous~     circulation (ROSC), survival to admission, survival to discharge from the hospital, and~     neurologic function at time of discharge from the hospital among patients experiencing out of~     hospital cardiac arrest randomized to receive either intra-arrest induction of therapeutic~     hypothermia (IATH) or post-arrest therapeutic hypothermia (TH).~      Specific aims~        1. Develop and test methodologies for randomizing out-of-hospital cardiac arrest (OOHCA)~          patients to receive one of two therapeutic hypothermia treatments in the prehospital~          environment.~        2. Randomize patients experiencing OOHCA to receive either IATH or post-arrest TH and~          assess the frequency of ROSC, survival to admission, survival to discharge, and~          neurologic function.~        3. Estimate the most efficacious volume of chilled saline administered during the intra~          arrest period.~        4. Identify barriers and strategies for the successful implementation of this project as a~          multicenter randomized trial.~   "
164437|NCT01413386|"~     Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent~     in their patency rate and safety at the 6 months after stenting.~   "
164438|NCT01413373|"~     Development of three-dimensional craniofacial cephalometric analysis for virtual planning in~     orthognathic surgery.~   "
164439|NCT01413360|"~     The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis~     patients whose serum liver enzymes are elevated more than upper limit.~   "
164440|NCT01413347|"~     The purpose of this study is to devise the method to reduce displacement of a left-sided~     double-lumen tube during patient positioning.~   "
164441|NCT01413334|"~     Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test,~     accurately evaluate anatomic coronary artery stenosis. However, anatomically-obstructive~     coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific~     ischemia. Recently, with the advance of imaging reconstruction and analysis technique,~     several novel parameters computed from CCTA were suggested to have added value in determining~     the ischemia-causing coronary stenosis. In this study, diagnostic performance of transluminal~     attenuation gradient (TAG) and fractional flow reserve computed form CCTA (FFR-CCTA) for the~     presence of hemodynamically-significant coronary stenosis, as determined by fractional flow~     reserve (FFR).~   "
164442|NCT01413321|"~     Hemiparetic gait following acquired brain injury (ABI) is grossly characterized by decreased~     speed of walking, increased stance time on the unaffected side, and decreased stance time on~     the affected side.These abnormalities are associated with a complex pattern of dysfunction~     including muscle weakness, spasticity, impaired sensory-motor control, long-term mechanical~     changes in muscles and joints, and cognitive impairments e.g. attention.\ At this stage of~     our knowledge it is still unclear which kinetic and kinematic parameters of hemiparetic gait~     provide insight about the different components of the complex pattern of dysfunction.~      A novel technique had been introduced in the Motion Laboratory of the Sheba Medical Center~     consisting of an ordinary treadmill that is equipped with a 'mat' of more than 5000~     high-quality capacitive pressure/force sensors. This treadmill developed by ZEBRIS enables~     to analyze gait and roll-off patterns on the treadmill.~      Aims of the study:~        1. To assess variability of data derived from the Zebris treadmill.~        2. To investigate stability of hemiparetic gait.~        3. To evaluate variability and relevant gait parameters taking place during recovery after~          acute ABI.~        4. To compare gait on ground with gait on treadmill.~      Rationale of the study- Basic assumptions of the study:~        1. No significant change in gait parameters is expected in both groups including healthy~          controls and chronic ABI subjects in recurrent examination within one week period.~        2. Subacute ABI patients are found to be within the context of neurorehabilitative recovery~          due to brain plasticity. Therefore a change in gait parameters is expected within two~          consecutive examinations in the chosen time intervals.~        3. All measurements are subject to error which contributes to the variance of outcomes.~      On the grounds of these assumptions:~      A. Two consecutive examinations in both groups including healthy controls and chronic ABI~     subjects are intended to estimate the error in measured values.~      B. Two consecutive examinations in the subacute ABI patient group are intended to estimate~     the contribution of neurorehabilitative recovery due to brain plasticity assessed with this~     unique research instrumentation.~   "
164547|NCT01411917|"~     Consenting subjects will be randomized to receive injection of bupivacaine or placebo before~     surgery for ileostomy takedown (injection administered after general anesthesia has been~     administered). Pain and side effects will be assessed periodically after surgery using the~     verbal Numeric Rating pain Scores, including at the timepoint of 24 hours after surgery. All~     subjects in this study will be given toradol to ensure adequate pain control.~   "
164443|NCT01413308|"~     Developed in the early 1970s, Fontan Operation has provided palliative care for patients with~     single ventricle physiology. Single ventricle is a rare subclass of the atrioventricular (AV)~     alignment abnormalities double inlet and common inlet ventricles (and rarely, straddling~     tricuspid valve), in which there is only one ventricular sinus [1]. Most patients present~     with symptoms of congestion , low cardiac output, and deep cyanosis immedietly after birth.~     Untreated, these heart anomalies are highly lethal. Neonatal heart transplantation is~     implacable because of shortage of donors. Fontan operation is a three staged palliative~     procedure: the single ventricle pumping blood to the systemic circulation , while blood flows~     laminarly to the lungs through direct anastomosis of the superior and inferior vena cavae~     (total cavo pulmonary connections), inevitably by-passing the right heart .~      This procedure has been shown to immediately correct the mixed venous blood dysfunction,~     providing treatment for the prominent signs of cyanosis.~      Along with its beneficial outcomes, Fontan circulation patients have been documented to have~     a variety of post-operative late complications. Of most substantial, increased systemic~     vascular resistance (mean of 10-15 mmHg higher) [2], systolic dysfunction as a result of~     decreased preload and increase afterload [3], and atrial arrhythmias [4].~      With the advent of bypassing right-heart circulation with Fontan operation, the pulmonary~     vascular bed is exposed to a new atmosphere of blood flow. Instead of physiological pulsatile~     flow in normal circulation, the pulmonary vasculature is receiving slow velocity, laminar~     flow [5]. Patients post-Fontan operations have been documented to have restrictive-type~     pulmonary function, but still yet to be correlated with Fontan circulation or as a possible~     result of prior lung tissue injury from the pre/intra-operation high volume blood flow.~     Regardless, Fontan patients are described to have decreased pulmonary function.~      The purpose of this research effort is to document and analyze the pulmonary function of~     those patients post-Fontan operation. It is still unclear as to what the long-term effects of~     Fontan operation are towards the pulmonary vascular bed, leaving us questions about the~     effects on lung capacities, ventilation-perfusion efficiency, and oxygen saturation.~   "
164444|NCT01413295|"~     The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have~     increased the mean survival of these patients. This outstanding advance is due to the~     extended indications for resection of hepatic metastases and to the use of new~     chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal~     antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is~     curative and the majority of patients are overwhelmed by the illness. The first line of~     treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with wild~     type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of~     responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic cells~     (DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A~     randomized phase II trial would be performed, by selecting two groups of patients, one of~     them would be treated with the best supportive treatment and the other with DCs plus the best~     supportive treatment. The aim of the study would be to analyze the outcome after 4 months of~     treatment. In patients treated with DCs, IFN-γ spot forming cells and proliferative responses~     would be determined pre and post treatment in lymphocytes stimulated with autologous DCs~     pulsed with autologous tumour antigens. Pre and post treatment serum levels of IFN-γ, TNF-α,~     TGF-β e IL-12, would also be measured.~   "
164445|NCT01413282|"~     The purpose of this study is to determine whether cardiac CT can improve triage of acute~     chest pain patients in the emergency department.~   "
164446|NCT01413269|"~     Early-stage breast cancer patients treated with breast conservative surgery are enrolled in~     this study if they meet defined criteria. Patients are randomized into two groups:~     conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is~     that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar~     efficacy and toxicity.~   "
164447|NCT01413256|"~     Background:~      Respiratory allergic reaction causes great suffering to millions of people worldwide. One of~     the most known allergen- is the pollen from vegetation, ragweed. Genus Ambrosia Ambrosia~     belonged to the complex ragweed flowers are pollinated by the wind and the plant's male~     flowers produce large quantities of small grains of pollen and airborne over long distances~     and those causes allergic reactions. The plant blooms between June and October, creating a~     second wave after wave of allergy caused by spring blossoms.~      This plant originated in North America has invaded many areas in Europe and in recent years,~     taking over large areas in Israel, Hula Valley and northern Acre Emek Hefer for a pen and~     layers to the south. After ragweed plants are based in particular they spread quickly and~     invade agricultural fields and significantly reduce the crop.~      High allergenic ragweed is a health hazard to humans. Ragweed plant investigated many aspects~     of North America and Europe in recent decades and extensive literature on ambrosia, but this~     is the first time ragweed study focuses on Israel.~      Working hypothesis and aims:~      Goal of this study is to identify the existence and nature of the sensitivity distribution of~     ragweed in Israel.~      Importance of research:~      A. Ragweed allergen testing and comparing the effect of exposure to plants on the sensitivity~     of the allergic Israeli patients~      B. The inclusion of ragweed allergen in the diagnostic and therapeutic panel~   "
164448|NCT01413243|"~     Trichuris suis ova (TSO) is a probiotic treatment based on the hygiene hypothesis, that has~     proven safe and effective in autoimmune inflammatory bowel disease. Clinical trails indicate~     that helminth infections have an immunomodulatory effect in multiple sclerosis as well.~     Investigators hypothesize that TSO® 2500 eggs given oral every 2 weeks for 12 months is - due~     to its immunomodulatory and antiinflammatory effect - in recurrent remittent multiple~     sclerosis and clinically isolated syndrome significantly more effective than an oral placebo~     treatment as assed by new T2 lesions in cerebral magnetic resonance imaging and clinical~     examination.~   "
164449|NCT01413230|"~     Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the~     skin, the joints, the nervous system and the kidney and may be life threatening.~      SLE is associated with production of autoantibodies and perturbations in regulatory T cells~     and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).~      Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.~      Immunomodulatory effects of vitamin D supplementation in VITRO was recently described,~     notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and~     CD8+ T cells and the decrease of Th17 cells.~   "
164450|NCT01413217|"~     Which is a better breakfast? Egg or cereal?~   "
164451|NCT01413204|"~     The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in~     patients with type 2 Diabetes for 24 weeks administration.~   "
164452|NCT01413191|"~     This phase II trial studies how well giving cixutumumab works in treating patients with~     metastatic melanoma of the eye. Monoclonal antibodies, such as cixutumumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them.~   "
164548|NCT01411904|"~     The purpose of this study is to determine if the magnetic needle, in combination with~     magnetic nanoparticles can accurately identify minimal residual disease in leukemia patients.~   "
164454|NCT01413152|"~     The main objective of this one year multidisciplinary research is to estimate the frequency~     of seropositive men having sex with men (MSM) under antiretroviral therapy (ART) having an~     undetectable blood viral load (VL) and a detectable VL in semen.~      Design: Participants'inclusion (n=150) will be done in 6 HIV hospital departments~     participating to the research project. To warrant feasibility and diversity of participants~     needed, the centers will be located in Paris and nearby suburbs. The study design is based on~     one blood and semen sample taken at day 0 and at day 30. Blood and semen samples will be~     taken in the enrolment centers. Biological and virological analyses will be performed by the~     laboratory of microbiology at Necker hospital, on blood and semen samples. Pharmacological~     analyses are planned in a subsequent study. Socio-behavioral data will be collected through a~     self-administered questionnaire at day 0 and day 30.~      Schedule: Patients' enrolment, collection of biological samples and questionnaires will last~     10 months (end of first quarter 2012). Biological and virological analyses will be performed~     until the end of the first semester 2012. Quantitative and socio-behavioral data will be~     analyzed during the third quarter 2012. Results will be released at the beginning of year~     2013.~   "
164455|NCT01413139|"~     The objective of this clinical investigation is to evaluate puncture site complication rate~     as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron~     Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal~     arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without~     the use of a closure device.~      The hypothesis is that the primary patency at 12 months is non-inferior to the primary~     patency obtained in the Durability study (72.2%).~   "
164456|NCT01413126|"~     Nut consumption is associated with reduced risk of Type 2 diabetes. The aim of this study was~     to assess the effects of peanut (whole or peanut butter) to breakfast meals on glycemic,~     insulinemic and selected gut hormone responses, appetite, and food intake over two~     consecutive meals in obese women with high Type 2 diabetes risk. Fifteen women participated~     in a randomized crossover trial where 42.5g of whole peanuts (P), peanut butter (PB), or no~     peanuts (control-C) were added to a 75g available carbohydrate-matched breakfast meal.~     Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids~     (NEFA), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), appetitive~     sensations and food intake were assessed after breakfast treatments and a standard lunch (75g~     available carbohydrate).~   "
164457|NCT01413113|"~     This phase I trial is studying the side effects and best dose of iodine I 131 when given~     together with pazopanib hydrochloride in treating patients with recurrent and/or metastatic~     thyroid cancer previously treated with iodine I 131 that cannot be removed by surgery.~     Radioactive drugs, such as iodine I 131, may carry radiation directly to cancer cells and not~     harm normal cells. Pazopanib hydrochloride may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving iodine I 131 together with pazopanib~     hydrochloride may be an effective treatment for thyroid cancer.~   "
164458|NCT01413100|"~     This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin~     together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil~     works in treating patients with systemic scleroderma (SSc). Stem cells are collected from the~     patient's blood and stored prior to treatment. To store the stem cells patients are given~     colony-stimulating factors, such as filgrastim (G-CSF) or chemotherapy (cyclophosphamide) to~     help stem cells move from the bone marrow to the blood so they can be collected and stored.~     After storage, patients are then given high-dose chemotherapy, cyclophosphamide, and~     immunosuppression with anti-thymocyte globulin to suppress the immune system to prepare for~     the transplant. The stem cells are then returned to the patient to replace the blood-forming~     cells that were destroyed by the chemotherapy and immunosuppression. After the stem cells~     have engrafted and have matured enough to support the immune system at approximately 2-3~     months, patients are given a medication called mycophenolate mofetil (MMF) or Myfortic. This~     medication is given to prevent worsening or reactivation of SSc and is referred to as~     maintenance therapy.~   "
164459|NCT01413087|"~     This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the~     safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following~     intratumoral administration of BC-819 and intravenously administered gemcitabine.~     Intratumoral injections of BC-819 will be performed using endoscopic ultrasound (EUS).~      Primary Objective: To assess the effect of intratumoral endoscopic ultrasound injection of~     BC-819 administered with intravenous gemcitabine on progression-free survival.~      Secondary Objectives: To compare the effects of intratumoral injection of BC-819 administered~     in combination with intravenous gemcitabine vs. intravenous gemcitabine alone on:~      Overall survival, Response rate, Resectability of the target tumor lesion, Quality of life,~     Safety, Serological Tumor Marker: CA 19-9, Duration of response, Failure-free survival~   "
164460|NCT01413074|"~     Primary Objective: The primary objective is to prospectively assess and compare survival in~     subjects with End Stage Renal Disease (ESRD) randomized to Peritoneal Dialysis (PD) or~     Hemodialysis (HD) treatment.~      Secondary Objectives: The secondary objectives are to prospectively assess and compare the~     following parameters in subjects receiving PD or HD treatment:~        -  Technique failure~        -  Cause of death~        -  Comorbidity status at baseline and changes throughout the study~        -  Change in residual renal function (RRF)~        -  Dialysis adequacy (i.e., Kt/Vurea)~        -  Change in blood pressure, hemoglobin, and S-phosphate~        -  Change in nutritional status~        -  Occurrence of bacterial and other infections~        -  Hospitalization, including number, duration, and underlying reason(s)~        -  Systemic inflammation as assessed by high-sensitivity C reactive protein (hs-CRP)~        -  Quality of life (QOL)~      Safety Objectives: To compare the nature and frequency of adverse events (AEs) and serious~     adverse events (SAEs), including abnormal laboratory test findings with clinical~     significance, in subjects receiving PD or HD treatment.~   "
164461|NCT01413061|"~     The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft~     with appropriate rigid internal fixation hardware as an alternative to autograft bone graft~     with rigid fixation in subtalar arthrodesis procedures. The primary objective of this~     clinical trial is to compare the overall fusion rate of the investigational to the control~     treatment. Fusion will be determined by clinical findings, radiographs and computed~     tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.~   "
164549|NCT01411891|"~     Joint replacement is becoming an increasingly common procedure. In 2005, 534,000 total knee~     arthroplasties (TKA) were performed in the United States which is at a rate of 18.1 per~     10,000 individuals, and the demand for primary TKA is projected to grow by 673% by 2030.~     Effective post-operative analgesia is an important component with regards to patient~     satisfaction and hospital stay. Regional anesthesia has been shown to decrease duration of~     surgery, need for transfusion, post-operative nausea and vomiting, and the incidence of~     thromboembolic disease in patients undergoing total knee or total hip replacement when~     compared with general anesthesia. Post-operatively, regional anesthesia has been shown to~     reduce pain scores and/or morphine consumption as well as opioid-related adverse effects.~      Epidural catheter or spinal anesthesia has become the standard of care at the University of~     Wisconsin-Madison for intraoperative management of TKA patients. General anesthesia is still~     occasionally used for patients that would strongly prefer a general anesthetic, those that~     are taking anticoagulation medications or with a coagulopathy, those with previous back~     surgery, and those with certain neurologic conditions such as multiple sclerosis or spina~     bifida. Comparison studies between lumbar epidural analgesia and femoral nerve catheters~     (FNC) for postoperative analgesia following TKA show no significant difference in pain~     scores, morphine consumption, or post-operative nausea and vomiting. However, epidural~     analgesia has been associated with higher incidence of hypotension and urinary retention.~     FNC's placed for postoperative pain allow patients to ambulate more effectively as there~     should not be much of a lower extremity motor block. Patients with a FNC for postoperative~     analgesia also do not require a urinary catheter which eliminates a common source of~     infection in postoperative patients. FNCs have also demonstrated improved rehabilitation~     times and decreased hospital stays which has led to an increased insertion rate of FNCs for~     postoperative analgesia following TKA at the University of Wisconsin.~      Pyarthrosis is a fairly common complication occurring at a rate of 2% following primary and~     5.6% following revision TKA. Infection can be a devastating complication following~     implantation of joint hardware often leading to extended hospitalization/rehabilitation stays~     and return trips to the operating room. The average billed charges for all types of revision~     TKA procedures was $49,360 with average length of stay of 5.1 days. Indwelling lines are a~     known infection risk and indwelling lines in the femoral region are known to be associated~     with a high incidence of catheter colonization. At 48 hours, Cuvillon et. al. found that 57%~     of FNCs placed without the use of a chlorhexidine impregnated patch had positive bacterial~     colonization. They also described three cases of transient bacteremia secondary to FNCs in~     the 208 catheters that they analyzed.~      Chlorhexidine impregnated patches also known as biopatches have been shown to reduce the~     incidence of bacterial colonization and infection of various indwelling lines including~     epidurals and central venous catheters. Currently no standard of care exists that requires~     the use of biopatches for FNCs. The investigators propose studying the use of the biopatch to~     reduce the incidence of bacterial colonization of femoral nerve catheters.~      The investigators will study the efficacy of the biopatch at decreasing the rate of bacterial~     colonization of FNCs in TKA patients. The FNCs will be inserted in the standard fashion and~     removed at the end of therapy. Typically the FNC infusion will continue until the morning of~     post-operation day (POD) #1 or 2. The process for FNC insertion first involves sterile prep~     and drape of the femoral region. Full sterile technique will be utilized including gown,~     gloves, and mask. Ultrasound guidance is then commonly utilized to identify the femoral~     nerve. Following patient sedation and skin infiltration with local anesthetic, a tuohy needle~     is inserted adjacent to the femoral nerve. A catheter is then threaded through the needle in~     close proximity to the femoral nerve. Patients will be randomized to either no chlorhexidine~     impregnated patch or to a chlorhexidine impregnated patch that will be located at the~     catheter exit site. On the morning of POD 1 or 2, the FNC infusion will be discontinued.~     Typically, Twenty-four to forty-eight hours after catheter insertion, it will be removed in a~     sterile fashion and the skin surrounding the catheter exit site will be swabbed and the~     distal catheter tip will be sent for culture to determine bacterial colonization. In~     addition, the investigators will interview patients and review clinical data to determine~     signs of infection and/or catheter tip colonization rates.~   "
164464|NCT01413022|"~     This phase I trial studies the side effects and optimal dose of PF-04136309 when given with~     combination chemotherapy (FOLFIRINOX; 5-fluorouracil, leucovorin, irinotecan, oxaliplatin) in~     treating patients with locally advanced or borderline resectable pancreatic cancer. These~     patients are not candidates for surgical resection which is the most effective treatment for~     pancreatic cancer. Giving PF-04136309 together with FOLFIRINOX may shrink pancreatic tumors~     in some patients so that surgery becomes an option~   "
164465|NCT01413009|"~     The main goal of the proposed Robert Wood Johnson Foundation's Interdisciplinary Nursing~     Quality Research Initiative (RWJF INQRI) project is to implement, analyze, and disseminate an~     evidence-based, nurse-led, inter-professional, multi-component program focused on improving~     the care and outcomes of critically ill adults.~   "
164466|NCT01412996|"~     This study aimed to compare the short term outcomes between SALC and conventional~     laparoscopic cholecystectomy (CLC).~   "
164467|NCT01412983|"~     The objective of this study is to determine the clinical feasibility and to evaluate the~     product performance of investigational contact lenses developed by Bausch + Lomb.~   "
164468|NCT01412970|"~     The purpose of this study is to evaluate the ability to measure central hemodynamics and~     heart-lung interactions non-invasively by electrical impedance tomography and compare it to~     clinically established hemodynamic monitoring.~   "
164469|NCT01412957|"~     The purpose of this study is to evaluate the benefit of panitumumab in addition to best~     supportive care compared to best supportive care alone in patients with chemorefractory~     wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.~   "
164470|NCT01412944|"~     The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous~     (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial~     responders to secukinumab.~   "
164471|NCT01412931|"~     Women are being asked to participate in a research study that is looking for new methods to~     understand and predict premature birth (birth before 37 weeks of pregnancy—full term~     pregnancy is 40 weeks). In this study the investigators will be looking at proteins in~     vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new~     form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and~     stiffness, in order to try to know who will have a preterm birth and who will reach full~     term. The investigators will collect the vaginal fluid samples and perform ultrasounds both~     in the clinic throughout pregnancy in normal women, and from women admitted to the hospital~     because they are in early labor. The investigators will collect the placental tissue after~     the baby is born (this is normally discarded). This study will help us to understand the~     process of preterm birth and the investigators hope that this will eventually allow us to~     develop better methods to treat preterm labor and prevent the birth of premature babies.~   "
164472|NCT01412918|"~     To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. To determine if~     there is a higher incident of expression of the sodium channel, voltage gated, type IX alpha~     subunit (SCN9) gene in those subjects with disturbing tinnitus than subjects that are not~     disturbed by tinnitus.~   "
164473|NCT01412905|"~     Objective: To test the accuracy of a referral system for diabetic eye disease conducted by a~     trained screener using a digital camera, a mobile medical unit and a centralized~     image-storing software in underserved, ethnically diverse neighborhoods in San Diego.~      Methods and Research Design: Retinal screening exams were offered at 8 community health~     centers for 1229 individuals, ages 16-80 years with diabetes throughout San Diego County over~     18 months. Images were captured with a special digital camera, securely transferred to a~     software system and read independently by a trained technician and retinal specialist. An~     analysis was conducted to evaluate who had severe eye disease and how accurate the reading of~     the technician were compared to the expert ophthalmologist readings.~      The investigators would like to demonstrate that telemedicine retinal screening utilizing a~     mobile medical unit with a trained technician in high-risk, ethnically diverse populations~     can accurately detect positive and negative disease. This may be a model to increase access~     to retinal examination in order to meet current guidelines and can allow more efficient use~     of the retinal specialist to evaluate and treat disease leading to a more cost efficient~     method of care.~   "
164474|NCT01412892|"~     Background:~      Patients with the genetic disorder neurofibromatosis Type 1 (NF1) are at increased risk of~     developing tumors of the central and peripheral nervous system. These include plexiform~     neurofibromas. The conventional treatment of these internal plexiform neurofibromas is~     surgery. This surgery can be possible on a single and limited tumor. On the other hand these~     tumors are often surgically intractable due to their multiplicity and their infiltrating~     characteristics Increased activity of mammalian target of rapamycin(mTOR) protein is seen in~     neurofibromas. mTOR inhibitor rapamycin , or its derivatives such as everolimus may slow or~     stop tumor growth in patients with NF1.~      Objectives:~      Primary objectives To determine whether everolimus has an effect on the volume of surgically~     intractable and life-threatening internal plexiform neurofibromas in patients with~     neurofibromatosis 1.~      Secondary objectives To determine whether everolimus has an effect on the number and the~     volume of cutaneous neurofibromas; to determine whether everolimus modify the signaling~     pathways in cutaneous neurofibromas.~      Eligibility:~      - Adults with neurofibromatosis type 1 with at least one internal plexiform neurofibroma,~     life-threatening or causing significant morbidity through compression of organs. This or~     these internal plexiform neurofibroma(s) should be intractable by surgery.~      Design:~      An open-label, single arm, non-randomized, single stage phase IIa study. Baseline phase:~     Baseline evaluations will be performed within 2 weeks, and up to a maximum of 4 weeks for~     specific exams, before the first dose of study drug.~      Treatment phase/duration of treatment: All patients will be treated with RAD001 10 mg p.o~     daily dose for one year except in case of unacceptable toxicity, death, or discontinuation~     from the study for any other reason.~      Follow-up phase: All patients will have two follow-up visits scheduled at 18 and 24 months~     after the first dose of the study drug to follow for adverse events (AEs) and serious adverse~     events (SAEs) that may have occurred after discontinuation from the study and for internal~     plexiform neurofibromas assessment.~      Radiological review: All Magnetic Resonance Imaging (MRIs) obtained at baseline, during the~     treatment period and the follow-up period will be reviewed by the Neuroradiologist of the~     study.~   "
164475|NCT01412879|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.~     Others interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy also work in different ways to kill more cancer cells or stop them from growing.~     It is not yet known whether rituximab is more effective with combination chemotherapy or~     bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing~     peripheral blood stem cell transplantation.~      PURPOSE: This randomized phase II trial studies how well giving rituximab together with~     combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy~     and peripheral blood stem cell transplantation works in treating older patients with~     previously untreated mantle cell lymphoma.~   "
164476|NCT01412866|"~     Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood~     disorders) smoke cigarettes, and most suffer related health consequences. Although combined~     treatment with medication and psychosocial therapy can help people with SMI to quit smoking,~     it is rarely used. Motivational interventions can enhance the use of combined treatment, but~     motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and~     Thresholds investigators have developed an easy-to-use, web-based electronic decision support~     system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has~     demonstrated excellent usability and increased engagement in smoking cessation treatments.~      One critical issue is the use of personalized health feedback. Motivational interventions for~     smoking cessation for smokers with SMI, including our EDSS, have included personal feedback~     from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke.~     Feedback regarding carbon monoxide is thought to motivate the user by personalizing the~     health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to~     implement, and largely unavailable in public mental health and primary care clinics. Further,~     research on use of carbon monoxide monitoring in the general population is equivocal. Another~     motivational strategy to personalize the negative health effects of smoking is a health~     checklist with feedback. Health checklists have been shown to be effective, are easy to use,~     have no expense, but have not been assessed separately from carbon monoxide monitor feedback~     among SMI smokers. Testing the effect of feedback from the health checklist compared to~     feedback from the carbon monoxide monitor is an essential next step in the development of~     this tool.~      Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess~     whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to~     higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist~     feedback alone.~      Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist~     feedback leads to higher rates of the distal outcomes, days of smoking abstinence and~     Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.~   "
164477|NCT01412853|"~     Context:~      Prostate cancer is the most common non-cutaneous cancer and the second most common cause of~     cancer-related deaths in European and North-American men.~      After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is~     often fluctuating and PSA nadir may only be reached after 2 years or more and may remain~     detectable several years after the completion of radiation. Moreover, PSA bounces and blips~     render patients and physicians very anxious about any possibility of a relapse. In this~     context, biomarkers that could predict the response to radiation earlier than PSA for~     patients with prostate cancer appear long overdue.~      Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive~     procedure which allows quantification of metabolites such as Choline, Creatine, Polyamines~     and Citrate within the prostate gland.~      Objectives:~      The investigators are conducting a French prospective study on the Evaluation of the Response~     to Irradiation with MR Spectroscopy (ERIS). Their purpose is to monitor the early response of~     radiation with 3D MR Spectroscopy during the first year after completion of radiation and its~     impact on biochemical control. Therefore, the ERIS trial aims to investigate whether or not~     there could be a correlation between the time course of PSA and that of Choline and Citrate.~   "
164478|NCT01412840|"~     Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard~     treatment to yield maximal pain relief, a period during which the patient suffers severe to~     intolerable pain. It would thus be valuable to further evaluate sterile water injection as a~     method for achieving rapid relief for this type of pain.~   "
164479|NCT01412827|"~     There has been a shortage of nuclear isotopes, not only in Canada but around the world. New,~     more sensitive SPECT cameras can obtain better images in shorter scan times. These cameras~     have also shown the ability to use a smaller dose of radioisotope to obtain the images. New~     software has been tested on the standard camera, the GE Infinia-Hawkeye SPECT/CT. The~     Diagnostic Imaging Department of The University of Ottawa Heart Institute has also acquired a~     new camera, the Discovery NM530c CZT and has been doing heart scans in shorter times. The~     investigators will now be looking at the quality of images using less isotope during SPECT~     myocardial perfusion imaging for diagnostic and prognostic purposes.~   "
164480|NCT01412814|"~     This study aimed to discover the biomechanics of gait pattern adaptation in patients after a~     total knee replacement.~      The first hypothesis of the project was that center-of-pressure manipulation at the foot~     during dynamic loading is capable of changing the forces, torques and muscle activation~     patterns of the lower limb.~      The second hypothesis of the project was that patient-specific center-of-pressure~     manipulation at the foot combined with repetitive perturbation training over time will~     improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain,~     quality of life and energy consumption in patients after a total knee replacement.~   "
164481|NCT01412801|"~     The study compared the magnitude of the antibody response and safety of a GBS Trivalent~     Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the~     study investigated the maternal to fetal transfer of antibodies induced by the~     investigational vaccine.~   "
164482|NCT01412788|"~     Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon~     patient's quality of life. Although peri-areolar incision has been widely used in benign~     breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary~     reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach~     in BCS for cancer patients has not been established by randomized, controlled trials.~      This trial was design to compare the Safety and aesthetic outcomes of breast conserving~     surgery between peri-areolar incision approach and traditional methods.~   "
164483|NCT01412775|"~     The study will examine the influence of a Cognitive Behavioral Therapy (CBT) short-term group~     intervention program on the levels of psychological stress and professional exhaustion~     experienced by the nursing staff in a cardiac department.~   "
164484|NCT01412762|"~     The purpose of this study is to learn more about what patients undergoing surgery for thyroid~     cancer expect from their surgery. Your input may help us to better prepare and inform~     patients about their disease and its treatment.~   "
164485|NCT01412749|"~     The goal of this data review research study is to create a registry database using~     information (data) collected from patients who have had Endoscopic Head and Neck Surgery~     (eHNS). Researchers want to use the registry database to learn more about short-term and~     long-term outcomes for patients who have eHNS.~      1.1 Primary Objective: To develop a registry database of patients who have had eHNS.~      1.2 Secondary Objective: To evaluate short-term oncologic parameters and functional outcomes,~     operative for patients undergoing eHNS performed at M.D. Anderson Cancer Center (MDACC).~      1.3 Tertiary Objective: To collect data on long-term oncologic outcomes including local and~     distant failure and survival following eHNS.~   "
164486|NCT01412736|"~     This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the~     effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma~     exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.~   "
193970|NCT01024608|"~     The purpose of the study is to assess the efficacy and safety of an investigational nasal~     aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.~   "
164487|NCT01412723|"~     Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and~     the leading cause of anemia in the world; this can occur at any age, but preschool children~     are at particular risk of developing it. This condition may cause serious repercussions for~     life, being a public health threat of considerable importance worldwide.~      Food fortification is considered the most effective solution to counter this situation,~     because it can help more people than other solutions. It is going to carry out a community~     trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a~     dietary supplement in preschool children of Medellin with depleted levels of iron; in terms~     of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized~     that at the end of the study the effect of milk fortified with iron amino acid chelate won't~     be less than the effect of fortified with ferrous sulfate.~      It is hoped that the results may contribute, albeit indirectly, to improve the health status~     of children with depleted levels of iron whom consume iron-fortified products.~   "
164488|NCT01412710|"~     The purpose of the present pilot study is to determine the effect of vitamin D~     supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk~     and in improving blood glucose control in type 2 Diabetes subjects . The investigators are~     working with Hispanics and African Americans living in Miami, Florida.~   "
164489|NCT01412697|"~     The investigators implemented a theory-based randomized controlled trial in ten rural~     Virginia middle schools in 2008-2010 and assessed the impact on health behaviors including~     fruit/vegetable intake as a primary outcome. Schools were randomized to intervention or~     control groups. Goal setting, peer leaders, and in-class workshops were intervention~     features. Seventh graders filled out surveys on health behaviors, psycho-social variables,~     and demographic characteristics. The investigators expected schools receiving the~     intervention to report a higher fruit-vegetable intake compared to control schools where~     students received standard health information. Sample (n=1,119) was 48.5% female, 50% White,~     with a mean age of 12.6 years. Fruit/vegetable intake was significantly higher in~     intervention schools at immediate post and at 1-year follow-up compared to controls.~   "
164490|NCT01412684|"~     Most resectable tumors arising in the body or tail of the pancreas are malignancies or~     premalignancies which are surgically treated with distal pancreatectomy in combination with~     splenectomy. Retrieval of the lymph node tissue which lies along the splenic vessels is~     necessary to complete an oncologically sound operation. Two techniques for spleen preserving~     distal pancreatectomy have been described, but only a small number of lesions are amenable to~     spleen preserving pancreas surgery because these operation compromise oncologic principles.~     Removal of a normal spleen usually does not cause immediate consequences but can make~     patients vulnerable to life threatening infections. Asplenic patients must be vigilant for~     these infections and antibiotic prophylaxis is recommended anytime a fever occurs.~     Splenectomy results in measurable changes in the cellular components of the blood. If~     thrombocytosis occurs as a result of splenectomy, it requires life-long antiplatelet~     treatment.~      Some childhood hematologic disorders such as hereditary spherocytosis are successfully~     treated with partial splenectomy. The post-surgical remnant spleen has been shown to be~     viable and functional. Both hematologic and immunologic function of the spleen seems to be~     preserved in most patients. Partial splenectomy has also been successful ly employed to treat~     benign and malignant lesions of the spleen. Unfortunately these indications for surgery are~     rare and so the experience with partial splenectomy is small.~      To date, distal pancreatectomy with partial splenectomy has not been described in the medical~     literature. The investigators have devised a surgical procedure combining distal~     pancreatectomy with partial splenectomy, in principal allowing preservation of splenic~     function without compromise of oncologic principles. This procedure is possible now because~     of new technology which allows for near bloodless transection of solid organs. These~     instruments are routinely used in liver, kidney and pancreas surgery. There are scattered~     reports of successful use of these instruments in splenic transection, but there is no large~     experience to date.~      The study intends to answer the question, is the proposed procedure, distal pancreatectomy~     and partial splenectomy, a viable alternative to the current standard of care, distal~     pancreatectomy with total splenectomy, for patients who will undergo surgical treatment of~     pancreas lesions arising in the body or tail of the pancreas?~   "
164491|NCT01412671|"~     This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal~     cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational~     study for patients with unresectable or advanced RCC under real-life practice conditions. The~     objective of this study is to assess safety and effectiveness of Nexavar at some limited~     sites which joined to clinical trial of Nexavar, before available of it in the market. The~     enrollment period is 2 months, and patients who received Nexavar will be recruited and~     followed one year since starting Nexavar administration. The data of this study will be~     integrated into the Nexavar PMS and the data will not be analyzed and reported alone.~   "
164492|NCT01412658|"~     Background: A novel milk peptide has been shown in laboratory setting to have natural~     anti-cancer properties and extend lifespan and improve metabolism in animal models. The~     purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine~     whether this novel milk peptide positively influence blood markers, metabolism and improve~     quality of life.~   "
164493|NCT01412645|"~     The aim of this study is to investigate potential metabolic effects of resveratrol in men~     with metabolic syndrome(otherwise healthy).~      The investigators hypothesize that resveratrol has an anti-inflammatory effect, and will~     increase insulin sensitivity, change the fat- and sugar-metabolism, and down-regulate~     bone-turnover.~   "
164494|NCT01412632|"~     The primary endpoint is to investigate the difference in pain between patients who receive~     deep sedation with spontaneous breathing versus patients who receive general anesthesia.~   "
164495|NCT01412619|"~     Patients after cardiac surgical operations often exhibit neuropsychological complications. In~     particular, the post-operative delirium is associated with a significantly increased~     morbidity and mortality.~      Intracerebral microembolization in addition to inadequate cerebral perfusion during surgery~     was verified as the main cause of this.~      The aim of the study is to demonstrate a correlation between intraoperative low measured~     cerebral oxygen levels and a loss neurological outcome, especially the development of~     postoperative delirium, using non-invasive cerebral oximetry (RSO2).~   "
164496|NCT01412606|"~     Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase~     pregnancy rate in women with unexplained infertility.~   "
164545|NCT01411943|"~     This study examines the relationship among epigenetic alterations and the development and~     persistence of psychoneurologic symptoms (cognitive dysfunction, depressive symptoms,~     anxiety, fatigue, sleep disturbance, and pain) in women receiving chemotherapy for early~     stage breast cancer. The relationship among inflammatory markers and psychoneurologic~     symptoms will also be explored. It is hypothesized:~        1. Chemotherapy triggers inflammatory activation, which in turn leads to the acquisition of~          genetic alterations. These alterations result in cellular changes and are modified over~          time.~        2. Inflammatory activation and epigenetic alterations are related to the temporal~          development, severity, and persistence of psychoneurologic symptoms.~   "
164497|NCT01412593|"~     Liver disease is a common medical problem in Saudi Arabia. Early studies indicated that~     around 10% of the Saudi population is either infected with hepatitis B or C. An estimated 12%~     of chronic HCV and HBV patients undergoing liver biopsy from Saudi centers have cirrhosis. Of~     these 3-5% would decompensate yearly thereby requiring liver transplantation. Based on the~     most recent national census figures, and a 1-2% prevalence rate of HBV and HCV nationwide, an~     estimated 1,000 patients would require liver transplantation on a yearly basis for~     decompensated cirrhosis.~      Liver transplantation is the only available life saving treatment for patients with end stage~     liver disease. Unfortunately less than 100 liver transplantations are performed in Saudi~     Arabia in three centers. Around 100 other patients travel abroad for transplantation annually~     while all other patients progressively deteriorate and eventually die from the complications~     of decompensated liver cirrhosis.~      In addition, even in patients who are listed for liver transplantation, often patients are~     too sick to wait on the transplant list that often takes more than a year and the on-list~     mortality is high. A procedure or an intervention that may help to stabilize liver function~     in order to help patients survive on the transplant list while awaiting liver transplantation~     would be of immense benefit. Examples of such interventions are already approved and used in~     some centers like the MARS system.~   "
164498|NCT01412580|"~     Because of the high returns of schooling in developing countries, policymakers pay a lot of~     attention to increasing school access. But if the mother is deficient in key micronutrients,~     brain development can biologically constrain children's demand for education. To execute this~     strategy, the investigators collect cohort observational data on a previous randomized~     controlled trial with micronutrient supplements offered to HIV-negative pregnant women in Dar~     es Salaam, Tanzania, between 2001 to 2003.~   "
164499|NCT01412567|"~     Prevention of perinatal transmission is essential to decrease the global burden of chronic~     HBV. Recombinant HBV vaccine and hepatitis B immunoglobulin (HBIG) given after delivery to~     the newborns of HBsAg positive mothers is the standard of care for prevention of HBV in~     babies. Some studies have however, shown that vaccine alone may be equally effective. Hence,~     immunoprophylaxis with hepatitis B vaccine with or without HBIG is effective in prevention of~     transmission of overt HBV infection to the babies. The primary outcome measure of most of the~     trials on immunoprophylaxis was the occurrence of hepatitis B, defined as a blood specimen~     positive for hepatitis B surface antigen (HBsAg). However, whether this immunoprophylaxis~     also prevents HBsAg negative HBV infection (occult HBV infection) in babies is not known. In~     the present study the investigators evaluated the efficacy of the two regimens; vaccination~     alone and compared it with vaccination plus HBIG administration at birth in preventing~     transmission of both overt and occult HBV infection to the newborn babies.~   "
164500|NCT01412554|"~     The purpose of this study is to identify risk factors for insulin resistance and to~     investigate the influence of insulin sensitivity on development of cardiovascular risk~     markers like blood pressure, heart rate, body build (weight, BMI, waist-hip ratio, skinfold~     thickness), reduced insulin sensitivity, diabetes mellitus, dyslipidaemia, and~     sympathoadrenal activity or manifest cardiovascular disease among young men during 10-20~     years.~   "
164501|NCT01412541|"~     The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of~     the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal~     angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.~   "
164502|NCT01412528|"~     Today a variety of diagnostic tools to detect allergenic agents are available such as skin~     tests, provocation tests and blood tests. Due to its high sensitivity and low costs the skin~     prick test is the most commonly used test to identify allergies in patients. By using this~     kind of skin test, up to 25 different agents can be tested in parallel, rendering the skin~     prick test a cheap, easy-to-handle and rapid diagnostic tool. However, as research proceeds,~     new tools appear with the intention to make future applications even more convenient -for~     both, the patient and the physician. For that purpose the development of the so called~     Easyprick Allergen Test System is under way, consisting of a foil that carries~     ready-to-use, allergen-soaked sponges which can easily be applied to the skin after pricking.~      Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic~     and non-allergenic components. In order to control variability and to achieve consistency and~     reproducibility for optimal safety and sensitivity/specificity, it is essential to~     standardize the amount of allergen used in prick tests. The present study aims to standardize~     eight allergen extracts by using this method. Standardized extracts will then be applied in~     the Easyprick Allergen Test System which will be evaluated and compared to the conventional~     prick test in a second study.~        -  Trial with medicinal product~   "
164503|NCT01412515|"~     Classic Kaposi's sarcoma (CKS) is an angioproliferation associated with human herpes virus 8~     (HHV8), which sometimes requires systemic treatment. Rapamycin and everolimus are mTOR~     inhibitors. The PI3K-AKT-mTOR pathway is activated in CKS.The aim of this study is to~     evaluate the rate of clinical response and tolerance to everolimus 10mg/d in CKS. Patients~     suffering from CKS will be enrolled in a multicenter two-stage phase II trial. At inclusion,~     all patients will have at least 10 lesions or more than one limb or 3% of body surface~     affected, in the absence of symptomatic visceral CKS. The primary endpoint is objective~     response to everolimus after 6 months therapy (complete or partial response per ACTG~     criteria). The trial is planned using Simon's minimax two-stage design to demonstrate a~     response rate of 50% as compared to 20% with type I error rate 2.5% and power of 90%.~     Accordingly, 11 patients will to be enrolled in the first stage and provided at least 3~     patients responded, 15 patients will be accrued in a second stage.~   "
164504|NCT01412502|"~     This study concerns the nearest relatives of patients who have passed away within 3 days of~     admission to an ICU due to: (1) brain death with multiple organ donation +/- tissues or (2)~     death via limitation and / or cessation of active treatment (LATA) without brain death or (3)~     sudden death of a previously healthy patient (no physical or mental limitations; MacCabe~     score = 0) within 3 days of admission to ICU without LATA nor brain death. Our primary~     objective is to determine the proportion of nearest relatives at risk for post traumatic~     stress disorder as defined by an Impact of Event Scale score greater than 37, and to compare~     this factor between the three above-mentioned groups.~   "
164505|NCT01412489|"~     The purpose of this study is to evaluate the intrauterine adhesion rate after the application~     of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were~     tolerance and side effect and subsequent fertility.~   "
164506|NCT01412476|"~     Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. However, the~     relationships between coenzyme Q10, antioxidant vitamins (Vitamin A, C, E) and the prevention~     of the risk of MS are still inconsistent. The purposes of this study are going to investigate~     the relation of coenzyme Q10, antioxidant vitamins concentration with the blood lipid levels,~     the markers of lipid peroxidation (TBARS), antioxidant enzymes activities (catalase,~     glutathione peroxidase and superoxide dismutase), and the inflammatory markers (hs-CRP,IL-6~     and adiponectin). The investigators will recruit MS patients (case group, n = 100) and~     age-gender matched healthy subjects from previous study(n = 105) as a control group . The~     inclusion criteria of MS are according to the Bureau of Health Promotion, Department of~     Health in Taiwan (2007).Hopefully, the results of this study could provide the information to~     what has been know in MS subjects. The investigators expect coenzyme Q10 or antioxidant~     vitamins could be a preventive supplement to reduce the risk of MS.~   "
164507|NCT01412463|"~     The objective of this study is to evaluate the immediate and long-term (up to 12 months)~     safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the~     treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal~     artery) between 40 mm and 180 mm in length.~   "
164508|NCT01412450|"~     This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in~     patients presenting with a narrowing or blocking at the level of the knee artery, which leads~     to a limited walking distance, rest pain or non-healing ulcers.~   "
164509|NCT01412437|"~     The investigators will use different types of brain imaging (MRI) in patients with~     Phenylketonuria (PKU) who are currently not on a strict diet to test the hypothesis that~     there is improvement in brain circuitry and biochemistry after return to diet and/or~     sapropterin dihydrochloride (Kuvan).~   "
164510|NCT01412424|"~     MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical~     product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety~     of MYCAPSSA™ treatment in patients with acromegaly.~   "
164511|NCT01412411|"~     The purpose of this study has been to understand the prevalence of under nutrition and~     develop effective interventions for improving growth and micronutrient status of infants~     receiving complementary foods.~      In this community based randomized clinical trial, the nutrition education package~     implemented aimed to improve hematological parameters including the micronutrient status and~     to see effect on growth indicators.~   "
164512|NCT01412398|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients in continuous ambulatory peritoneal dialysis~     (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to~     assess safety and efficacy of using Fosrenol in clinical practice. This study is also all~     case investigation of which the enrollment period is one year, and all patients in CAPD who~     received Fosrenol for hyperphosphatemia will be recruited and followed one year.~   "
164513|NCT01412385|"~     The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option for~     patients with primary immunodeficiency (PID) diseases.~   "
164514|NCT01412372|"~     The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in~     patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will~     evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma~     cytokines before and after treatment with Lialda.~   "
164515|NCT01412359|"~     The overall purpose of this study is to determine if replacing standard soybean oil based fat~     emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the~     progression of parenteral nutrition associated cholestasis. It is a compassionate use~     protocol for patients who already have significant cholestasis related to parenteral~     nutrition.~   "
164516|NCT01412346|"~     The purpose of this study is to investigate the effects of a Nordic diet rich in plant-based~     foods and fish on indicators of cardiovascular disease risk at two different levels of salt~     intake.~      The study is a 20-wk randomized controlled crossover trial. The subjects follow a~     salt-restricted diet during the study. The study begins with a 4-wk run-in phase for all~     subjects. After that the subjects are randomly allocated to one of two groups. Group 1~     consumes a healthy Nordic low-salt diet enriched with plant-based foods and fish for 16~     weeks. Group 2 consumes a low-salt diet for 16 weeks. During the 16 weeks, both groups~     receive salt and placebo capsules in a double-blind, crossover fashion (8+8 weeks).~   "
164517|NCT01412333|"~     This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy~     and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with~     relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab~     600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the~     first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks,~     with placebo injections matching interferon beta-1a SC three times per week; or interferon~     beta-1a 44 mcg SC injections three times per week (with placebo infusions matching~     ocrelizumab infusions every 24 weeks).~   "
164518|NCT01412320|"~     Purpose of the study is to characterize the potential acute and long-term improvement of~     dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).~      Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a~     double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial~     effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day~     long-term, double blind, placebo-controlled parallel study the chronic effects of dietary~     flavanols on vascular function in 52 patients with ESRD will be evaluated.~   "
164546|NCT01411930|"~     Antipsychotic medicines used to treat mental illnesses have been associated with effects on~     blood sugar control. Laboratory studies have shown that certain medications in particular may~     alter how insulin works. One purpose of this study is determine if antipsychotic medications~     have immediate effects on insulin action in individuals who do not have a mental disorder,~     but who have risk factors for diabetes. A second purpose is to demonstrate the feasibility of~     using volunteers without psychiatric disorders, and who do not take psychiatric medications,~     as a means for studying antipsychotic metabolic effects.~   "
165885|NCT01394432|"~     The investigators hypothesised that endocardial stem cells implantation following after~     percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse~     remodeling in patients with primary acute myocardial infarction.~   "
164519|NCT01412307|"~     Management of patients with recurring Hodgkin lymphoma (HL) after stem cell transplantation~     failure represents a typical unmet medical need prompting active development and validation~     of new agents and treatment strategies. The LEBEN protocol combines two agents, lenalidomide~     and bendamustine, framing different targets on both tumor and microenvironmental cells of HL.~     These agents, while showing a low risk of overlapping extrahematologic toxicities, may hit~     the proliferation machinery of H-RS cells and/or their progenitors, synergistically inhibit~     tumor-related angiogenesis and interfere on cytokine-mediate circuitries operating in the~     microenvironment to support tumor cell survival.~      A weekly schedule of bendamustine, at 60 mg/m2, is combined with the continuous~     administration of increasing dose of lenalidomide (10, 15, 20 e 25 mg dose levels in a 28-day~     cycle). Such schedule of Bendamustine is aimed at enhancing the antiangiogenic and~     immunomodulatory activity of continuous Lenalidomide, as studies have shown that low and~     protracted doses of alkylators induce a decrease in microvascular density of tumor tissues~     and inhibit mobilization and viability of circulating endothelial progenitors.~      The Bayesian phase 1/2 dose finding method of Thall and Cook was employed. This method~     chooses doses based-on both response and toxicity, and accounts for the trade-off between~     these two outcomes.~   "
164520|NCT01412294|"~     The aim of this study is to evaluate efficacy and safety of Capecitabine/Cisplatin for~     gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.~   "
164521|NCT01412281|"~     The purpose of this study is to assess the humoral immune response and safety of the~     parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V~     using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly~     adults, using the EMA (European Medicines Agency) regulation as a guideline.~   "
164522|NCT01412268|"~     1. Obesity is a big health problem worldwide.~        2. Mostly obese people have food addiction and bad eating habits.~        3. Bariatric surgery is a good alternative for patients who failed to loose weight with~          other measures like behavioral changes, activities and sports, diet, etc..~        4. The investigators know the changes occurred after surgery in eating habits due to~          restrictive and malabsorptive feature of the surgery performed.~        5. There is no study in the literature to measure these changes.~        6. The investigators will try to detect these kind of behavioral changes by a survey before~          and after surgery.~   "
164523|NCT01412242|"~     Prospective cohort study aimed at simplifying the diagnostic approach to symptomatic patients~     with the clinical suspicion of deep vein thrombosis (DVT) of the lower extremities. All~     patients will receive a pre-test clinical probability (PTP) and the determination of D-dimer.~     Patients with low PTP and negative D-dimer will have the diagnosis ruled out. All other~     patients will undergo compression ultrasonography (CUS) of the proximal vein system. Patients~     with negative CUS and either low PTP or negative D-dimer will have the diagnosis ruled out,~     while those with high PTP and positive D-dimer will undergo extensive ultrasound~     investigation of the calf vein system. All patients in whom the diagnosis of DVT is ruled out~     will be followed-up prospectively up to three months for documenting the development of~     symptomatic thromboembolic events.~   "
164524|NCT01412229|"~     This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head~     and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged~     appropriate for non-surgical definitive therapy.~   "
164525|NCT01412216|"~     The purpose of this study are twofold:~        1. To understand the effects of physical inactivity (sedentarism) on vascular function,~          insulin resistance and inflammation;~        2. To assess the role of a dietary intervention (fish oil) in counteracting the effects of~          physical inactivity on vascular function and inflammation.~   "
164526|NCT01412203|"~     Childhood obesity is a major public health threat. Physical activity and healthy eating~     contribute to the maintenance of healthy weights. Individually oriented behaviour change~     programs may not be able to overcome the influence of what has been called an obesogenic~     environment. Action Schools! BC (AS! BC) used a socio-ecological approach to enhance~     opportunities for physical activity and healthy eating in elementary schools and created~     systemic change at the provincial level. AS! BC helps elementary schools customize action~     plans, based upon their local context, to contribute to the health and well-being of children~     and the school community. Pilot research showed that AS! BC was an effective and feasible~     model. The provincial dissemination of AS! BC has been launched and partners from across many~     sectors are involved to enhance the sharing of knowledge and increase the implementation of~     the AS! BC model across British Columbia. The dissemination provides an unprecedented~     opportunity for evaluating how changing the school environment can promoted healthy weights~     in children. The dissemination was evaluated using a cluster randomized design; 30 elementary~     schools (n = 1529 consented children) from four (out of five) provincial health authorities~     volunteered to participate.~      The primary goals of the research are:~        1. to determine if the Action Schools! BC (AS! BC) model is an effective approach to~          positively change school environments and health related behaviours of children from~          diverse geographical regions and cultural groups, and~        2. to determine if the supports provided to schools or the community context influence the~          uptake and use of the AS! BC model.~      This research will contribute to the science of obesity prevention and knowledge use as well~     as public health practice.~   "
164527|NCT01412190|"~     The purpose of the study is to evaluate the safety and efficacy of Restylane Vital White~     administered with an injector device on aged skin in the face, hands and décolletage.~   "
164528|NCT01412177|"~     The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of~     Meniere's disease.~   "
164529|NCT01412164|"~     The study aims to further assess the safety, efficacy and the performance of its delivery~     system of FIREHAWK rapamycin-eluting stent up to five years.~   "
164530|NCT01412151|"~     The purpose of this study is to extend findings from the creatine dose-finding study~     (CREST-UP1) in Huntington's disease to evaluate the long-term safety, tolerability, and~     clinical impact of high dose creatine.~   "
164531|NCT01412138|"~     Human endometrium is a very dynamic tissue characterized by cyclical process of~     proliferation, differentiation and cellular shedding as part of each menstrual cycle. This~     issue suggests the presence of somatic stem cells. Endometriosis is characterized by presence~     of endometrium outside the uterine cavity. The existence of a somatic stem cell population in~     endometrium could explain the incorrect proliferation of these cells, which would lead to~     formation of endometriotic foci.~   "
164532|NCT01412125|"~     Huntington's disease (HD) is a rare, autosomal dominant, progressive neurodegenerative~     disorder typically becoming noticeable in middle age. It is clinically characterized by~     progressive involuntary movements (bradykinesia and hyperkinesia), neuropsychiatric~     disturbances (depression, irritability), and cognitive impairments progressing to dementia.~      The striatum (caudate and putamen) is the primary area of neuronal degeneration in HD. Today,~     there is no validated curative treatment. HD affects approximately 6 000 patients in France~     and more than 30 000 individuals are considered at risk for this disease.~      While the disease gene is discovered and we are capable to do a predictive genetic diagnosis~     for asymptomatic patients, there is no clinical or biological way to predict the age of onset~     or the progressive profile of patients.~      One of the fundamental characteristics of this disease is its extreme variability from one~     patient to other both in terms of their evolution and their onset of action. Thus, this~     inter-individual variability severely limits the genetic counselling and complicating the~     neurological assessment.~      Increasingly, it has been assumed that modifier genes may be the source of this~     inter-individual variability and that their identification could help the understanding and~     prediction of disease progression.~      Given that the mutant protein is ubiquitous, the molecular dysfunction of neurons could be~     found in peripheral cells from the bloodstream and will be more accessible to investigation.~   "
164533|NCT01412099|"~     The purpose of this research study is to evaluate the effectiveness of two methods of~     delivering information about nutrition and physical activity to non-traditional college~     students. Participants will receive either a printed feedback report alone, or the feedback~     report in addition to a series of phone calls from a peer counselor. The peer counselors will~     provide nutrition and physical activity counseling using motivational interviewing~     techniques. Nutrition and physical activity outcomes will be measured for both groups and~     compared.~   "
164534|NCT01412086|"~     This study evaluated the inter- and intra-rater reliability of the GEBA Scale with~     photonumeric guide for the assessment of overall eyebrow fullness. There is no treatment~     (intervention) associated with this study.~   "
164535|NCT01412073|"~     trial of 3 protocols to determine the best one to control blood loss during caesarean section~   "
164536|NCT01412060|"~     The objective of this study is to evaluate the efficacy and safety of cariprazine relative to~     placebo in the prevention of relapse of symptoms in patients with schizophrenia.~   "
164537|NCT01412047|"~     How does long term treatment with Soliris affect HAHA in PNH patients?~   "
164538|NCT01412034|"~     The available medications used to treat HoFH are targeted at reducing circulating levels of~     total and LDL-cholesterol. These measures can retard the progression of cardiovascular~     disease, however, they are unlikely to regress existing disease due to years of cholesterol~     accumulation in the vessel walls and therefore cannot adequately reduce the existing risk for~     an ischemic event. HDL has multiple actions that could lead to plaque stabilization and~     regression, such as rapid removal of large quantities of cholesterol from the vasculature,~     improvement in endothelial function, protection against oxidative damage and reduction in~     inflammation. This study will assess the effects of CER-001, a recombinant human Apo-A-1~     based HDL mimetic, on indices of atherosclerotic plaque progression and regression as~     assessed by 3Tesla MRI measurements in patients with HoFH.~   "
164539|NCT01412021|"~     This study of Humira will be conducted to clarify the following with regard to the treatment~     of juvenile idiopathic arthritis affecting multiple joints with this drug:~        -  Unknown adverse drug reactions (especially important adverse drug reactions)~        -  Incidence and conditions of occurrence of adverse reactions in the clinical setting~        -  Factors that may affect the safety and effectiveness of Humira~   "
164540|NCT01412008|"~     Since the use of botulinum toxin in treating spasticity has already been proven effective, we~     are now using magnetic resonance imaging to examine the toxin diffusion within muscle (post~     injection) in order to determine the specific toxin dose required for an optimal treatment~     response.~   "
164541|NCT01411995|"~     The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain~     associated with intrauterine device (IUD) insertion. They will be randomized to either~     placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically~     via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be~     assessed using a visual analog scale prior to insertion. Using the same pain scale, patients~     will again be asked at the end of the procedure to rate their pain.~   "
164542|NCT01411982|"~     This study will identify the role of PACAP (pituitary adenylate cyclase-activating~     polypeptide) deficiency in patients with nephrotic syndrome. PACAP is a neuropeptide that has~     a putative role as an inhibitor of megakaryopoiesis and platelet function. Patients with~     nephrotic syndrome show decreased PACAP plasma levels, due to urinary loss. We hypothesize~     that in severe nephrotic syndrome, plasma deficiency of PACAP enhances megakaryopoiesis and~     causes blood platelet activation, which contribute to the increased rate of thromboembolic~     disease in these patients.~      To test our hypothesis, the role of PACAP deficiency on pro-thrombotic state in patients with~     nephrotic syndrome will be studied using patient blood and urine samples.~   "
164543|NCT01411969|"~     The aim of this study is to present new data for a better understanding of the anatomic~     correlation of these two notches.~      This study included 32 nasal cavities (16 individuals) with external nasal dilator strip~     (Breath Right®) and after decongestion (0.05% oxymetazoline chloride applied as an aerosol~     spray);~   "
164544|NCT01411956|"~     Researchers have linked media messages such as television programs to multiple problematic~     health behaviors. The narrative style of many television programs—involving a plot, recurrent~     characters, entertaining situations, and familiar settings—makes them compelling and likely~     contributes to the powerful influence these programs can have on behavior. However, narrative~     messages are not frequently utilized for prosocial purposes. In particular, health education~     embedded in a narrative context has been neither commonly utilized nor carefully evaluated.~     Using constructs from two complementary theories of health behavior, family physicians in a~     large metropolitan region have developed a situation comedy entitled White Coats that aims~     to provide quality patient education. The program currently airs on a local public access~     channel. The objective of this project is to evaluate the effect of one particular episode of~     White Coats on patient beliefs regarding hypertension.~   "
164550|NCT01411878|"~     This study is comparing the impact of two teen pregnancy prevention interventions, Reducing~     the Risk and Love Note with a non-related training on community building to determine which~     is most effective for which participants in delaying sexual initiation, enhancing use of~     condoms and other forms of birth control, decreasing sexually transmitted diseases and~     decreasing the number of pregnancies. The participants were 1450 youth between the ages of 14~     and 19 including those from poor urban settings, those from immigrant and refugee families~     and those from the foster care system. Both girls and boys were be in the study. The~     investigators predict that girls, immigrants and refugees and foster youth will have better~     outcomes when participating in Love Notes, a program focused on healthy relationship~     formation and maintenance as a frame for how to manage the sexual aspect of relationships~     while boys and urban youth will have better outcomes when participating in Reducing the Risk.~     Both groups will have better outcomes than those in the control condition.~   "
164551|NCT01411865|"~     Diabetes is a common and serious chronic disease. However, there is a large gap between the~     level of care that people should receive (based on research and guidelines) and the level of~     care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the~     Canadian Diabetes Association has a strategy to improve heart disease screening and treatment~     for people with diabetes. This study will evaluate whether the strategy works. The focus of~     the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them~     delivery better care for their diabetic patients. In Ontario, only half of doctors received~     this Toolkit. We will compare the quality of care received by diabetic patients whose doctors~     received this Toolkit versus those who doctors did not.~   "
164552|NCT01411852|"~     Primary Aim: To determine the feasibility and safety of hypotensive resuscitation for the~     early treatment of patients with traumatic shock compared to standard fluid resuscitation.~      Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive~     resuscitation will result in the same volume of early crystalloid (normal saline) fluid~     administration compared to standard crystalloid resuscitation. The null hypothesis regarding~     safety is that hypotensive resuscitation will result in the same percent of patients~     surviving to 24 hours after 911 call received at dispatch compared to standard fluid~     resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival~     in the Emergency Department or until hemorrhage control is achieved in the hospital,~     whichever occurs earlier.~   "
164553|NCT01411839|"~     The current HIV treatment adherence project was designed to adapt culturally and then pilot~     test an empirically supported cognitive-behavioral therapy program for adherence and symptoms~     of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.~   "
164554|NCT01411826|"~     To evaluate online peer support and colorectal cancer screening behavior among individuals~     who are not currently meeting colorectal cancer screening guidelines. This is a randomized~     controlled trial.~   "
164555|NCT01411813|"~     This study examines the role of anxiety in food intake among patients with AN by measuring~     caloric intake in a standardized, laboratory meal with alprazolam versus a placebo. Patients~     will participate in two test meal sessions, one after receiving alprazolam and one after~     receiving a placebo. Patients will be administered psychological measures of anxiety, mood,~     and eating behavior. Primary outcomes include caloric intake in a laboratory test meal and~     pre-meal anxiety levels.~   "
164556|NCT01411800|"~     The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and~     safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.~   "
164557|NCT01411787|"~     This is a randomized, single-site pilot study incorporating one control group. This research~     involves an exercise group and a non-exercise group (control group).~      The patients who are in the exercise group will be enrolled in the Dallas County Women's~     Adventure Boot Camp. This will require them to undergo exercise training 3 times per week,~     under the direction of an experienced personal trainer in a group setting. All Boot Camp~     personal trainers are trained in basic cardiac life support (CPR) and are trained to watch~     for any signs or symptoms associated with a poor exercise response.~      The investigators hypothesize that randomizing women to a supervised exercise program of core~     conditioning, muscular/circuit training, and short distance running administered during~     neoadjuvant chemotherapy for breast cancer can be performed.~      Patients will continue on study as they are undergoing neoadjuvant chemotherapy for their~     breast cancer. This will be about 4 - 6 months.~   "
164558|NCT01411774|"~     The investigators are conducting a randomized double-blind placebo-controlled study to assess~     the efficacy of d-cycloserine augmentation of cognitive-behavioral therapy for the treatment~     of pediatric obsessive compulsive disorder. This study represents an innovative approach in~     translating bench research findings into clinical research and testing a new approach for~     optimizing an effective psychotherapy with a safe non-psychotropic medication.~   "
164559|NCT01411761|"~     Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are~     favorable microorganisms that regulate the flora of the gastrointestinal system. In this~     study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and~     duration of phototherapy on very low birth weight infants.~   "
164560|NCT01411748|"~     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal~     system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida~     colonization. The objective of this study is to evaluate the efficacy of prophylactic S~     boulardii in reducing the candida colonization and infection in very low birth weight~     infants.~   "
164561|NCT01411735|"~     BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure~     and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and~     therapy.~      METHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with~     controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial~     of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen~     consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI;~     Doppler-echocardiography; and vascular ultrasound.~   "
164562|NCT01411722|"~     The study aims to assess 1) the electrical activity of the diaphragm in mechanically~     ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical~     activity of the diaphragm may predict the weaning outcome~   "
164563|NCT01411709|"~     A pilot investigation into the stress relieving properties of Vitano® which will assess the~     following hypotheses~      Individuals exposed to Vitano® will demonstrate diminished blood pressure and heart rate~     responses to mental stress compared to individuals in the control condition~      Physiological recovery (BP, HR and cortisol) from mental stress will be enhanced in~     individuals exposed to Vitano® compared to individuals in the control condition~      Vitano® will have positive effects on cognitive functioning.~      Subjective ratings of stress will be reduced in individuals exposed to Vitano® compared to~     individuals in the control condition~      There will be a significant improvement in subjective well-being in individuals taking~     Vitano®.~   "
164564|NCT01411696|"~     This is a retrospective data collection study to evaluate the efficacy, safety, and~     re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following~     informed consent, there were no patient study visits. All data was collected via chart~     review.~   "
164565|NCT01411683|"~     This study aims to compare mandibular overdentures retained either by mini or standard size~     implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and~     oral health-related quality of life. We will also evaluate post surgical discomfort, the~     success rate of prostheses and implants in the long term, denture quality and costs.~   "
164566|NCT01411670|"~     The purpose of this study is to investigate the effects on systemic hemodynamics,~     microcirculation and organ function of human Protein C concentrate in patients with sepsis~     and septic shock.~   "
164567|NCT01411657|"~     Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to~     enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in~     diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF delivery~     to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement~     (improve vision indices) in ischemic optic neuropathy. Patients in the trial will receive an~     NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to~     evaluate safety and efficacy.~   "
164568|NCT01411644|"~     This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian~     dysfunction (WHO III status).~   "
164569|NCT01411631|"~     There is some evidence that polyphenols can affect cognitive function. Therefore, consumption~     of polyphenols has the potential to prevent cognitive impairment or even enhance cognitive~     performance. The objective of this study is to investigate the effect of polyphenol~     consumption served in the form of Concord Grape Juice (CGJ) on cognitive performance and~     driving performance in Mums.~      The study design will be a repeated measures, double-blind, randomised, placebo controlled,~     crossover study. There will be 2 conditions; CGJ and a placebo drink. 20 participants will~     undergo two 12 week dietary interventions which will entail daily consumption of a 12oz~     serving of CGJ or placebo in a counterbalanced manner. There will be a 4 week washout period~     between conditions. At baseline, 6, and 12 weeks of each 12-week treatment arm cognitive~     performance and driving performance will be assessed (using the driving simulator at the~     Institute for Transport Studies). CGJ is a common ingredient in commercially available~     products.~      Mums will be defined as mothers of pre-teen children (aged under 13 years) who are aged~     40-50. This population generally have hectic and stressful lifestyles and therefore there is~     potential for this population to receive cognitive benefit from polyphenol consumption.~   "
164570|NCT01411618|"~     The daily removal of supragingival dental plaque is a major factor in the prevention of~     caries, gingivitis and periodontitis. Proper control of bacterial plaque is obtained through~     the mechanical removal of the biofilm by the proper use of the toothbrush and floss. However,~     some studies have shown that the mean time of brushing tooth surfaces is less than that~     required to obtain a proper cleaning 1 and only 2-10% of the patients use dental floss~     regularly and effectively 2. In addition, it has been demonstrated that even after education~     and motivation of the patient to the proper use of toothbrush and floss, its compliance is~     reduced with time 3. The result is the persistence of plaque in some areas, particularly on~     the interproximal surfaces of teeth. Many studies have demonstrated the effectiveness and~     usefulness of antiseptic mouthwashes containing active ingredients such as chlorhexidine~     (CHX) and essential oils (EO) to prevent and control the formation of plaque and gingivitis,~     when used in addition to mechanical procedures 4-7. Chlorhexidine is still the gold standard~     for its antimicrobial action and high substantiveness, but side effects, such as~     pigmentation, taste alteration and the formation of supragingival calculus limit its~     continued use 8. Essential oil (EO) mouthwashes have been used for years as an adjunct to~     brushing in addressing oral hygiene. Their effectiveness in controlling plaque and gingivitis~     are well documented in literature 9-14. They kill microorganisms by destroying their cell~     walls and inhibiting their enzymatic activity 15,16. Furthermore, phenolic compounds like EOs~     are known to interfere with the inflammation process 17,18. The antibacterial action is~     particularly effective for the ability of the mouthwash with EOs to penetrate the biofilm~     19-21. The traditional EO mouthwashes contain ethanol, a chemical used to dissolve numerous~     substances in mouthwashes, including CHX. The concentration of ethanol present in the~     mouthwash with EOs is more than 20%, sufficient to dissolve the EOs but not enough to carry~     out a direct antibacterial effect 22,23. Many aspects against the use of alcohol in~     mouthwashes, such as its effects on the surfaces of composite restorations 24 and its~     possible role in the formation of oropharyngeal cancer are being discussed 25,26. Although a~     direct correlation of the cause and effect between the occurrence of oropharyngeal cancer and~     the use of mouthwashes with alcohol 27, has not demonstrated so far, it is considered~     desirable to eliminate ethanol for use in daily mouthwash, bringing in search of new~     formulations. Recently, an EOs containing mouthwash without alcohol was introduced on the~     European market (Daycare, Curaden, Kriens, and Suisse). To our knowledge, to date there are~     no published data on the effectiveness of this antimicrobial product. The rinsing with this~     mouthwash can cause fewer side effects but, in contrast, it may be less effective.~      The aim of this study was to evaluate the inhibitory properties of a new alcohol free EO~     containing mouthwash with respect to the traditional mouthwash containing 21.3% ethanol,~     through a standard 3-days plaque regrowth model.~   "
164571|NCT01411605|"~     Worldwide, childhood and adolescent obesity has reached epidemic proportions despite major~     efforts to promote weight reduction. Pediatric obesity commonly presages adult obesity and is~     associated with the development of weight-related comorbid conditions and increased~     morbidity.~      Regular physical activity is an important modality of obesity management. Despite~     controversies, poor exercise tolerance has frequently been reported in youth obesity and the~     cause of this limited exercise tolerance remains unknown. Several factors accompanying~     obesity may interfere with exercise tolerance in obese populations. Respiratory factors, such~     as decreased thoracic compliance, increased airway resistance and breathing at low pulmonary~     volumes are associated with obesity and may impact exercise intolerance in this population.~     Moreover, even in people with otherwise normal lungs, the normal ventilatory responses to~     exercise can become constrained in obesity. A thorough understanding of the mechanisms~     underlying this exercise intolerance remains fundamental in order to favour long term~     adherence to exercise training. This is especially true in youth populations, in which the~     management of overweight and obesity must be undertaken as soon as possible, due to the early~     onset of cardiovascular risk factors.~      The main purpose of this study is to determine early-onset cardio-respiratory mortality~     factors in obese adolescents as well as their relation with exercise intolerance (i.e.~     dyspnea) when compared with age and gender-paired normal-weight volunteers.~   "
164572|NCT01411592|"~     The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic~     RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the~     impact of the adhesive system used an established resin cement with an integrated adhesive~     monomer (Panavia 21 TC) and a resin cement with a separate primer (Multilink Automix with~     Metal/Zirconia Primer) were compared within the study on a randomized basis.~      The aim of the present randomized study was to evaluate wether the difference in bond~     strength of Panavia and Multilink Automix with Metal/Zirconia Primer to densely sintered~     zirconia ceramic (IPS e.max ZirCAD, Ivoclar Vivadent) has any impact on the clinical outcome~     of all-ceramic RBFDP with a cantilevered single-retainer design.~   "
164585|NCT01411423|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have been administered with Nexavar for~     unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess~     safety and effectiveness of Nexavar under real-life practice conditions. This study is an all~     case investigation of which the enrollment period is 15 months, and all patients who received~     Nexavar will be recruited and followed one year since starting Nexavar administration.~   "
164737|NCT01409447|"~     Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently~     used to treat cartilage defects. The investigators had previously developed a biphasic~     osteochondral composite as the construct for chondrocyte implantation. The investigators~     further conducted this feasibility study of such device to treat patients with osteochondral~     lesion of the knee joints.~   "
164573|NCT01411579|"~     One of the most recent and interesting field of diagnostic imaging is diffusion-weighted MR~     imaging (DW-MRI). Various studies evaluated the application of DW-MRI to diffuse liver~     disease and focal liver lesions providing controversial results, probably due to the~     difficult reproducibility of the apparent diffusion coefficient (ADC) measurements. It is~     conceivable that a wide inter/intra-individual variability actually exists in the apparent~     diffusion coefficient (ADC)-values, and that each apparent diffusion coefficient (ADC)-value~     presents an higher reliability in measuring the temporal changes of water diffusion within~     the same individual (longitudinal-evaluation), than in characterizing tissues between~     different patients (transverse-evaluation). For these reasons, some previous studies assessed~     the application of DW-MRI in predicting the chemotherapy (CHT) outcome in liver metastases.~     The rationale of these studies was the overt biochemical changes shown by the neoplastic~     cells after CHT and the sensitivity of DW-MRI in the identification of such changes. The same~     authors noticed that the metastatic lesions with the lowest ADC-values present also the best~     outcome after CHT. Moreover, these studies suggest that it could be possible to assess if~     each single patient will respond (R) or not (NR) to the CHT through liver DW-MRI performed~     from 3 days to 3 weeks after the beginning of CHT.~   "
164574|NCT01411566|"~     The purpose of this study is to evaluate an integrative therapeutic concept for schizophrenic~     patients with comorbid substance use disorder.~   "
164575|NCT01411553|"~     Null hypothesis: (1) there is no difference in rates of ICU-acquired infection based on using~     disposable or cleaned, reusable ECG leadwires and (2) In cardiac surgical telemetry floors,~     there is no difference in false or nuisance sightings or crisis calls based on using~     disposable or cleaned, reusable ECG leadwires.~   "
164576|NCT01411540|"~     The purpose of this study is to compare a diet containing whole grains versus an energy~     matched diet using refined grains on body composition and metabolism.~   "
164577|NCT01411527|"~     By clinical examinations and withdrawing of blood samples from a large number of healthy~     Danish children, this study will reveal if age of pubertal onset is declining. Furthermore,~     the extensive normative data will provide detailed insight into normal ranges and individual~     changes of anthropometrics and hormone levels in healthy children during childhood and~     adolescence.~   "
164578|NCT01411514|"~     The management of MS-patients requires treatment with immune-modifying or immune-suppressive~     agents to prevent new relapses and progression of disability. Several studies have evaluated~     the effect of steroid treatment on clinical recovery after an acute relapse. An important~     unanswered clinical question is, whether or not an oral tapering dose of corticosteroids~     offers any additional advantage over intravenous methylprednisolone alone in improving~     neurologic recovery as well as safety and tolerability after a relapse.~      This study aims to compare the efficacy, tolerability and safety of tapering doses of oral~     prednisone and placebo after short-term high-dose i.v. methylprednisolone on the recovery~     from an acute relapse in patients with clinically isolated syndrome (CIS),~     relapsing-remitting multiple sclerosis (RR-MS) and primary (PP-MS) or secondary progressive~     multiple sclerosis (SP-MS) with superimposed relapses.~      Patients will be treated during 25 days with de-escaling doses of prednisone or placebo.~      The primary analysis will test whether placebo is equivalent to oral prednisone taper on the~     recovery status as measured by EDSS change from baseline to 3 months after baseline.~   "
164579|NCT01411501|"~     A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25~     has the same effect as lactulose in unaided self-defecation frequency of a week and has~     better effect in symptoms improvement (in press). The object is to evaluate whether~     acupuncture is effective for functional constipation. As an explanatory research, it took one~     single point as its intervention and sham acupuncture as its control group (patients were~     blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized~     controlled trial to further evaluate whether acupuncture is more effective than routine~     treatment. Acupuncture prescriptions used in this trial are individually prescribed according~     to syndrome differentiation, which can improve clinical effect. .~   "
164580|NCT01411488|"~     The purpose of the study is to determine the prevalence of anal erosions within a 14 day~     period among adult ICU patients at Cleveland Clinic Main Campus who receive one of two fecal~     management systems (FMS).~      Null Hypothesis: There is no difference in the rates of anal erosion between the twp fecal~     management systems in a 14 day period.~      Alternative Hypothesis: One fecal management system is no worse than the second fecal~     management system in the development of anal erosion.~   "
164581|NCT01411475|"~     The LATINA registry aims at assessing a new classification of bifurcation restenosis in the~     prediction of major adverse cardiac events in patients who have previously undergone a~     succesful percutaneous bifurcation intervention.~   "
164582|NCT01411462|"~     VIBER aims at assessing angiographic outcome of drug-eluting balloon angioplasty assisted by~     the Vascular Imaging Balloon Catheter (VIBE, Volcano, San Diego, CA) device, which integrates~     a predilation catheter with electronic intravascular ultrasound capabilities.~   "
164583|NCT01411449|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Primovist for contrast~     enhancement in MRI of liver. The objective of this study is to assess safety, especially in~     relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total~     2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and~     followed 7 days after the injection.~   "
164584|NCT01411436|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Nexavar for unresectable~     hepatocellular carcinoma (HCC). The objective of this study is to assess safety and~     effectiveness of Nexavar under real-life practice conditions. This study is an all case~     investigation of which the enrollment period is 2 or 3 months (dependent on sites) for~     Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with~     Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be~     recruited and followed one year since starting Nexavar administration.~   "
164597|NCT01411267|"~     This is a phase I study of the investigational drug AC220 combined with cytarabine and~     etoposide in patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous~     leukemia (AML).~   "
164598|NCT01411254|"~     This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for~     diabetic macular edema.~   "
164586|NCT01411410|"~     This open label Phase 1 study involves treating subjects with advanced cancer with BAY80-6946~     in combination with paclitaxel. It will determine the maximum tolerated dose (MTD) and the~     recommended Phase 2 dose (RP2D) of BAY80-6946 in combination with paclitaxel. The trial will~     involve multiple participating sites from the US. Following determination of the MTD, an~     expansion cohort of 20 evaluable subjects with breast cancer was planned. Finally, 16~     patients have been enrolled to treatment (Cohort 3). A new expansion cohort with modified~     dosing cohort is now introduced (Cohort 4: breast cancer expansion cohort with modified~     dosing) in which another 20 subjects are planned to be enrolled to treatment.~   "
164587|NCT01411397|"~     Primary suture repair increases the risk for recurrence, the fact of benefit of mesh repair~     in elective situations is documented, and many studies have reported beneficial outcomes of~     mesh hernioplasty in emergency situations. Still there is controversy of using such grafts in~     presence of intestinal resection.~   "
164588|NCT01411384|"~     This study attempts to compare Corneal Hysteresis (CH) and Corneal Resistance Factor (CRF) in~     a series of keratoconic eyes before and after Corneal collagen cross-linking (CXL).~     Furthermore, among the objectives of the study is to reveal correlations between CH and CRF~     and a series of corneal indexes like the Corneal Thickness (CT), mean keratometry (Km) and~     corneal astigmatism (Astig).~      The study adhered to the tenets of the Declaration of Helsinki and written informed consent~     was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ),~     in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing~     primarily on the conditions of the anterior segment of the eye.~      Participants were recruited from the Outpatients Cornea service of the EIT in a consecutive~     if eligible basis. Fifty (50) eyes of thirty (30) patients with keratoconus were recruited~     for the sake of the study and formed the keratoconus group (KG). Eligible subjects for the~     keratoconus group had to present progressive keratoconus in consecutive corneal topographies,~     changes in refractive power, and deterioration of the visual acuity within a period of two~     years. Exclusion criteria included glaucoma, glaucoma suspicion, and intraocular pressure~     (IOP) lowering drugs administration. Further to glaucoma, exclusion criteria included central~     corneal thickness (CCT) less than 400μm, K-readings more than 60D, a history of herpetic~     keratitis, corneal scarring, severe eye dryness, pregnancy or nursing, current corneal~     infection, or underlying autoimmune disease.~      Fifty (50) eyes of fifty (50) non-keratoconic, age-matched, individuals who visited our~     outpatient service formed the control group (CG). Further to keratoconus, and a spherical~     equivalent error above 3D, the same exclusion criteria applied to the control group members,~     as well. All participants wearing contact lenses were instructed to discontinue contact lens~     wear at least a month before measurements.~      CRF and CH parameters were obtained while the patient was sitting on a chair in front of the~     Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device.~     Upon successful fixation of the patient's eye on a red blinking target, the operator~     activated the device. An air puff was released by a non-contact probe, which scanned the~     central area of the eye and sent a signal to the ORA. In brief, the air puff causes the~     cornea to move inward, past applanation, and into slight concavity. After milliseconds, the~     air pumps shut off, the pressure decreases, and the cornea begins to return in its normal~     state. The system monitors the entire process and measures two pressure values, which are~     determined from the inward and outward applanation processes. The aforementioned measuring~     procedure enables the determination of CH which is related to the viscoelastic structure of~     the corneal tissue, and is calculated as the difference between the two pressure values at~     the two applanation processes, and CRF which is indicative of the overall resistance of the~     cornea and is calculated as a linear function of the two pressures associated with the two~     applanation. In order to ensure accurate results, ORA was done four times for each eye, by~     the same operator. Signals that differ significantly in appearance from the other signals~     from the same eye were deleted.~      The same surgical procedure was applied to all keratoconus patients that included:~     Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of~     a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent~     de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of~     0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops~     every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and~     aqueous was stained yellow. The ultraviolet A (UVA) radiation source that was used is UV-XTM~     (IROC AG, Zurich, Switzerland). In details, an 8.0mm diameter of central cornea was~     irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of~     3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during~     irradiation, as well, in order to sustain the necessary concentration of the riboflavin.~     Moreover, balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.~      After treatment all patients were prescribed topical ofloxacin drops qid, fluorometholone qid~     and diclofenac nitrate qid, accompanied by frequent instillation of artificial tears. Soft~     therapeutic lens was applied until complete re-epithelialization of the cornea was detected.~     Follow up visits were performed on the 1st day, 7th day, 1st, 3rd, 6th and 12th month after~     the operation.~   "
164589|NCT01411371|"~     Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity~     and mortality associated with the other. The investigators hypothesized that restoration of~     normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart~     failure. This study randomizes patients with heart failure and persistent AF to medical~     treatment of AF or catheter ablation to restore sinus rhythm.~   "
164590|NCT01411358|"~     The purpose of this study is to evaluate the antibody response to each of the three influenza~     vaccine strains included in the licensed seasonal flu vaccine, as measured by~     hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly~     subjects in compliance with the requirements of the current European Union (EU)~     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed~     flu vaccine (CPMP/BWP/214/96).~   "
164591|NCT01411345|"~     1. The investigators hypothesize that increasing radiation dose to the functional~          MRI-defined lesion in the prostate bed will result in an improved initial complete~          response (reduction in prostate-specific antigen (PSA) to < 0.1 ng/mL), which is related~          to long-term outcome biochemically.~        2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor~          regions.~        3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that~          are related to an adverse treatment outcome.~        4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because the~          patients will be aware that the dominant tumor will be targeted with higher radiation~          dose.~   "
164592|NCT01411332|"~     1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to the~          dominant tumor lesion in the prostate as identified by multiparametric MRI will increase~          tumor eradication from the prostate.~        2. Biomarker expression levels differ in the multiparametric MRI defined regions at high~          risk of harboring tumors that determine outcome.~        3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related~          to an adverse treatment outcome.~        4. Quality of life will not differ significantly between the treatment arms.~        5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients~          will be aware that the dominant tumor will be targeted with higher radiation dose.~   "
164593|NCT01411319|"~     The hypotheses of this study are:~        1. Delivery of single fraction Lattice Extreme Ablative Dose (LEAD) radiotherapy (RT) to~          the dominant tumor lesion(s) in the prostate as identified by multiparametric functional~          Magnetic Resonance Imaging is safe and feasible.~        2. Biomarker expression levels differ in the functional MRI identified suspicious tumor~          regions and unsuspicious tumor regions. The investigators hypothesize that a significant~          source of variation in biomarker levels is due to tumor heterogeneity and that it is~          molecular abnormalities in the dominant tumor areas that are angiogenic and determine~          outcome.~   "
164594|NCT01411306|"~     Despite medical advances, half of the patients admitted to hospital for recovery from acute~     illness, injury or surgery have swallowing difficulties and those requiring tubes for~     breathing support are at even greater risk. Difficulties with swallowing decrease patients'~     quality of life, prolong their hospital stay, as well as lead to medical complications such~     as pneumonia, malnutrition and death. Presently, there is no screening test for swallowing~     difficulties in patients who have required respiratory support. Screening will allow for~     early detection of swallowing problems which is important to prevent serious complications,~     such as pneumonia. This research will determine the accuracy of a new screening test, the~     Toronto Bedside Swallowing Screening Test (TOR-BSST©) previously tested with stroke patients,~     to predict the presence of swallowing difficulties in patients who have required breathing~     support for longer than 48 hours. The investigators will enroll 100 patients from the~     intensive care medical surgical units at the University Health Network. The findings from~     this research will help identify those patients with swallowing problems earlier than it is~     currently possible. Once identified, at risk patients will be referred to a speech language~     pathologist swallowing expert for more comprehensive testing; thereby, decreasing their risk~     of experiencing serious complications, such as pneumonia, secondary to swallowing problems.~   "
164595|NCT01411293|"~     The purpose of this study is to define whether the acute consumption of low-fat milk protects~     against postprandial vascular endothelial dysfunction by reducing oxidative stress responses~     that limit nitric oxide bioavailability to the vascular endothelium. The investigators~     hypothesis is that the consumption of low-fat milk will improve postprandial vascular~     endothelial function in an oxidative stress-dependent manner that allows greater nitric oxide~     (NO) bioavailability. The objectives of this study are to 1) examine improvements in~     postprandial vascular endothelial function in response to low-fat milk ingestion, 2) define~     low-fat milk-mediated improvements in circulating biomarkers of redox status, and 3) define~     the mechanism by which low-fat milk improves NO bioavailability. Collectively, the successful~     completion of these studies is expected to define NO mediated activities of low-fat milk that~     protect against vascular endothelial dysfunction in individuals at high risk for developing~     CVD.~   "
164596|NCT01411280|"~     The purpose of this study is to assess whether methylphenidate is effective in enhancing the~     cognitive performance of children with the HbSS or HbSC genotype of SCD who have sustained~     neurological complications on laboratory-based measures of sustained attention, reaction~     time, and executive functions, and indirectly, verbal short-term and long-term memory.~   "
164599|NCT01411241|"~     The aim of the study is to assess whether the second CYD dengue vaccination could be~     administered concomitantly with the booster vaccination of a pediatric combination vaccine~     (Pentaxim™) during the same day and visit but in 2 different sites of administration.~      Primary Objective:~        -  To demonstrate the non-inferiority of the antibody response against all antigens~          (diphtheria, tetanus, pertussis, polio and Hib) in participants receiving one booster~          dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue~          vaccine compared to subjects receiving one booster dose of Pentaxim™ vaccine~          administered concomitantly with placebo.~      Secondary Objectives:~        -  To describe the safety of Pentaxim™ vaccine administered concomitantly with the second~          dose of CYD dengue vaccine, or administered concomitantly with placebo.~        -  To describe the safety of the CYD dengue vaccine in all subjects after each dose.~        -  To describe the antibody response to each dengue virus serotype (post-Dose 2 and~          post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with~          Pentaxim vaccine or administered alone.~        -  To describe the antibody response to each dengue virus serotype post-Dose 2 and~          post-Dose 3 in all subjects.~   "
164600|NCT01411228|"~     A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in~     pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher~     disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase)~     or PB-06-005 (naïve treatment with taliglucerase alfa).~   "
164601|NCT01411215|"~     This is an open-label, multicenter and observational study in China, which is designed to~     record the data of RA & AS patients within 52 weeks after rheumatologists decided to~     prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible~     subjects agreed to be recruited in the study and can withdraw anytime if they choose so.~      Patients with RA or AS are typically managed by rheumatologists. As this study seeks to~     record the data of RA & AS patient in etanercept and evaluate the safety and efficacy of the~     treatment, patients will be recruited from Rheumatic department. Rheumatologist will be asked~     to build up the database for RA & AS patient surveillance prospectively in outpatient dept,~     which benefits for the patient treatment outcomes evaluation and clinical management.~   "
164602|NCT01411202|"~     Patients with cancer may experience problems with their breathing due to a fluid accumulation~     around their lungs called malignant pleural effusion (MPE). This fluid can be drained but~     draining may not stop the fluid from accumulating again. MPE can cause shortness of breath~     during activity and at rest leaving patients feeling as though they cannot catch their breath~     enough to be comfortable. Other symptoms can include pain, cough and weight loss.~      One way to stop the fluid from accumulating is to create scar tissue between the lung and~     chest wall so there is no more room for fluid accumulation. This procedure is called~     pleurodesis. Pleurodesis is the standard of care at most centres across Canada. This~     procedure is done by injecting a drug into the space between the lung and chest wall through~     a catheter, Doxycycline is one of the drugs currently used for this purpose. Traditionally,~     patients are admitted for pleurodesis, mostly because the size of the catheter used to inject~     the medication is very large but also because of the potential complications that can happen~     with these larger chest tubes.~      At our centre, most patients with MPE are managed at home with a smaller sized catheter known~     as a Pleurx catheter. The Pleurx catheter allows patients to remain at home for treatment and~     trained staff come into the home to both drain the MPE and monitor the patient. Sometimes,~     patients experience pleurodesis through use of the Pleurx catheter alone.~      Pleurodesis with doxycycline can happen faster than with the Pleurx catheter alone. It has~     been our experience with a limited number of patients that it is safe to perform pleurodesis~     using the Pleurx catheter for doxycycline injection in an outpatient setting.~   "
164603|NCT01411189|"~     Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy,~     endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal~     resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric~     spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic~     therapeutic procedures will be evaluated based on the proportion of patients with suppressed~     gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by~     an independent committee.~      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and seven days after administration.~   "
164604|NCT01411176|"~     Patients with early gastric cancer, who require therapeutic upper gastrointestinal endoscopy,~     such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will~     receive intragastric spraying of NPO-11 or placebo. The superiority of NPO-11 to placebo as~     anti-peristaltic agent will be verified in a randomized, double-blind, parallel-assignment~     design based on the proportion of patients with suppressed gastric peristalsis during the~     procedures. The degree of gastric peristalsis is assessed by an independent committee.~      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and seven days after administration in comparison with~     the placebo group.~   "
164605|NCT01411163|"~     The purpose of this clinical trial is to extend the Pre-Crest-X study to further assess the~     long-term safety and tolerability of up to 30 grams daily creatine in individuals at-risk for~     Huntington's Disease (HD) and to assess whether biomarkers responsive to creatine in~     symptomatic individuals are informative in premanifest individuals over a longer duration.~   "
164606|NCT01411150|"~     The purpose of this clinical trial is to extend the Pre-Crest study (Protocol # (NCT00592995)~     to further assess the long-term safety and tolerability of up to 30 grams daily creatine in~     individuals at-risk for Huntington's Disease (HD) and to assess whether biomarkers responsive~     to creatine in symptomatic individuals are informative in premanifest individuals over a~     longer duration.~   "
164616|NCT01411020|"~     The purpose of this study is to determine a effect-site concentration of propofol in children~     3 to 11 years effective to make a induction of general anesthesia.~   "
164617|NCT01411007|"~     The purpose of this study is to develop a technique to provide feedback of brain activity and~     to use this technique to reduce levels of craving in nicotine dependent smokers. The~     researchers will use a brain scan called functional magnetic resonance imaging (MRI). MRI~     uses magnets to take pictures of your brain. Functional MRI measures brain blood flow that is~     related to brain activity. This measure of brain activity can be presented or feedback to~     volunteers.~   "
164607|NCT01411137|"~     The study had three distinct parts and is described as follows:~      Part 1:~        -  To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD~          IR to IPX066 in subjects with advanced PD~        -  To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an~          exploratory computer-based system, in assessing dexterity and mobility in a subset of PD~          subjects.~      Part 2:~      • To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions~     in eligible subjects who successfully completed Part 1 of the study.~      Part 3:~      • To further evaluate the long-term safety of IPX066 in eligible subjects who successfully~     completed Part 2.~   "
164608|NCT01411124|"~     This is a double-blind, placebo-and active-controlled 3-period crossover study designed to~     assess the effect of GEn 600 mg on simulated driving performance in healthy volunteers.~   "
164609|NCT01411111|"~     Leukotrienes are potent inflammatory molecules produced mainly by mast cells, eosinophils,~     monocytes/macrophage and neutrophils in response to allergic or inflammatory stimuli.~     GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that~     attenuates the production of leukotrienes, through the blockage of the first committed step~     in the leukotriene pathway, 5 lipoxygenase (5-LO) activation.~      GSK2190915 has been shown to be an in vitro inhibitor of human organic anion transporting~     polypeptides 1B1 and 1B3 (OATP1B1 and OATP1B3), hence there is a potential for a~     pharmacokinetic drug-drug interaction with OATP1/ B1 substrates such as the anti-lipidemic~     rosuvastatin.~      This study will evaluate the effect of repeat oral dosing of GSK2190915 (30milligram (mg) and~     100mg) on the steady-state pharmacokinetics (PK) of rosuvastatin (10 mg). In addition, the~     study will evaluate the safety and tolerability of this combination when co-administered to~     healthy, adult volunteers in two cohorts.~   "
164610|NCT01411098|"~     This phase I trial studies the side effects and best dose of radiation therapy when given~     together with cisplatin and etoposide in treating patients with non-small cell lung cancer~     that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor~     cells. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Drugs, such as cisplatin, may make tumor cells more~     sensitive to radiation therapy. Giving radiation therapy together with cisplatin and~     etoposide may kill more tumor cells.~   "
164611|NCT01411085|"~     Note: In June 2013, the study design was changed from a randomized controlled study of~     risperidone + despiramine vs. risperidone vs. placebo to an open label pre-post study of~     risperidone (or risperidone-like drug) + desipramine. The aims of the study were revised to~     read:~        1. To determine whether participants treated with risperidone in combination with~          desiprmaine have less alcohol use (fewer drinking days; fewer heavy drinking days)~          during the final 8 weeks on these medications as compared to pre-baseline. The primary~          hypothesis is that compared to pre-baseline, participants will demonstrate fewer days of~          drinking (per week), as well as fewer days of heavy drinking (per week) in the final~          eight weeks they are taking risperidone and desipramine, as recorded on the Timeline~          Follow-Back assessment~        2. To explore changes in symptoms (of schizophrenia and of depression) in the final eight~          weeks of treatment with risperidone + desipramine compared to the period before baseline~        3. To assess the side effect burden associated with the combination of these two~          medications in participants.~      The original aims of the study were:~      The purpose of this study is to determine whether participants who are treated with~     risperidone in combination with desipramine have less alcohol use (fewer drinking days; fewer~     heavy drinking days) than do participants who are treated with RISP with placebo. The primary~     hypothesis is that compared to treatment with risperidone, participants randomized to a~     combination of risperidone plus desipramine will have fewer days of drinking, as well as~     fewer days of heavy drinking. The study will also compare the effects of risperidone as~     compared to risperidone plus desipramine on participants' symptoms and side effects.~   "
164612|NCT01411072|"~     Chemotherapy is given after curative surgery for pancreas cancer to try to improve cure~     rates. There are two choices of chemotherapy which are currently considered equal treatments:~     gemcitabine or 5-fluorouracil (5FU). This study is trying to determine if one of two standard~     chemotherapies is better than the other depending on whether patients have high or low human~     equilibrative nucleoside transporter 1 (hENT1). hENT1 is a protein that is found in varying~     amounts on pancreas cancers.~   "
164613|NCT01411059|"~     This is an Intervention Development Study (IDS) to quantify the physical demands (using~     biomechanical investigation) of a 2-phase (beginning & intermediate), 32-week yoga program~     designed for community-dwelling older adults. Additionally, the IDS will explore the~     adherence and adverse events of participation in the program. Data from the IDS will be used~     to develop evidenced-based yoga programs, which the investigators postulate will be~     associated with fewer musculoskeletal side effects compared to non-evidence based yoga~     programs. The investigators also postulate that evidenced-based tailoring of yoga for seniors~     will enhance adherence and efficacy. The programs developed during this IDS will be tested in~     an expanded, Phase II, Randomized Controlled Trial.~   "
164614|NCT01411046|"~     Development of glucocorticoid (GC)-induced adrenal insufficiency is a serious adverse effect~     of GC treatment. It is today not possible to predict this adverse effect. The project aims at~     investigating a possible individual aspect, which may render subjects more or less sensitive~     to glucocorticoids, and thereby influence development of GC induced adrenal insufficiency.~     The hypothesis is that subjects with one or another of the polymorphisms in the GC receptor~     gene will either have increased or diminished GC sensitivity. This may be responsible for~     differences in development of GC induced adrenal insufficiency.~   "
164615|NCT01411033|"~     The purpose of this study is to evaluate the development and progression of chronic~     complications (retinopathy, neuropathy, diabetic chronic renal disease, cardiovascular~     events) in patients with type 1 diabetes treated from the onset of the disease with~     recommended method of intensive insulin therapy. All patients attended a five-day structured~     training program during first hospitalization and re-education once year during the~     observation. After five years of observation and next - once a year chronic complications are~     assessed. The investigators would like to evaluate also the relationship of the management of~     the disease, knowledge about the treatment and diabetes, insulin resistance and inflammatory~     markers with development and progression of chronic complications.~   "
164619|NCT01410981|"~     The purpose of this study is to understand if small proteins found on the surface of myeloma~     cells (called CXCR4 and CD47) or inside the myeloma cells (Pim kinases, sphingolipids, and~     pS6) can predict how patients will respond to chemotherapy-treatment and if a small molecule~     inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma. A~     sample from the bone marrow biopsy (a small amount of tissue removed from the body for~     laboratory testing) and aspirate (a small amount of fluid is removed from the body for~     laboratory testing) that had been done before the subject entered this study will be provided~     for research purposes. Based on preliminary data, it is hypothesized that CXCR4, CD47,~     sphingolipids, and Pim kinases could be used as prognostic/predictive markers and that Pim~     kinase inhibitors provide a new agent for the treatment of multiple myeloma.~   "
164620|NCT01410968|"~     The purpose of this study is to provide a safety and feasibility basis for future studies~     addressing the hypothesis that subcutaneous vaccination with dendritic cells loaded with~     multiple antigenic epitopes expressed by pancreatic tumor in combination with systemic~     administration of Poly-ICLC (Hiltonol) will induce anti-tumor immunity.~   "
164621|NCT01410955|"~     Irinotecan is one of key drug used in the treatment of colorectal cancer. The incidence of~     irinotecan induced diarrhea varies between 60-90%, with severe diarrhea in 20-40%. The main~     cause of diarrhea is one of irinotecan metabolites, SN-38 which is in the liver~     glucuronidated and subsequently expelled into the intestine. Due to the bacterial enzyme~     beta-D-glucuronidase in intestinal lumen it is deconjugated. This form causes direct damage~     of intestinal mucosa associated with malabsorption and the development of diarrhea. It is~     known that probiotic bacteria, reduce activity of intestinal beta-D-glucuronidase and~     therefore these bacteria could be applied in the prevention of diarrhea in patients treated~     by this food supplement. Given their low toxicity, good tolerability, probiotics may be an~     important part of supportive therapy. This is a first study aimed to determine the~     effectiveness of the probiotics in the prophylaxis of irinotecan induced diarrhea due to~     reduction intestinal beta-D-glucuronidase activity.~   "
164622|NCT01410942|"~     The goal of this clinical research study is to learn about the effect of different~     combinations of exercise, supportive counseling, and methylphenidate/placebo for the~     treatment of fatigue in patients with prostate cancer. The safety of this treatment~     combination will also be studied.~      Methylphenidate is a stimulant designed to increase the activity of the central nervous~     system.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     symptom, disease or illness. It is designed to be compared with a study drug to learn if the~     study drug has any real effect.~      The exercise in this study is designed to help improve your physical fitness and energy~     levels.~      Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression,~     pain, and/or sleep disorders.~   "
164623|NCT01410929|"~     The objective of this post market clinical study is to collect prospective clinical data to~     confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the~     spine caused by multiple myeloma.~   "
164624|NCT01410916|"~     This protocol is designed to collect safety and efficacy data on patients that have been or~     will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in~     Germany.~   "
164625|NCT01410903|"~     The purpose of this study is to evaluate source data for the survival and the investigation~     of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.~   "
164626|NCT01410890|"~     -  The primary objective of this study is to characterize the pharmacokinetics of~          alglucosidase alfa manufactured at the 4000 L scale in patients who have a confirmed~          diagnosis of Pompe disease.~        -  A secondary objective of this study is to evaluate and explore the relationship between~          anti-rhGAA antibody titers and the pharmacokinetics of alglucosidase alfa.~   "
164627|NCT01410877|"~     It is hypothesized that different inhalation profiles (inhalation flow rate versus time~     curves) result from different forms of patient training. Furthermore, significant~     inter-subject variability in these profiles should exist that can, under some circumstances,~     depend on the design of different inhalation devices; this is because dry powder inhalers~     have different airflow resistances. The investigators also hypothesize that the spread of~     flow rate versus time profiles for inhalation can be collected. Finally, these profiles can~     be analyzed from a group of human subjects and used to define a mean and statistical range of~     inhalation flow rate versus time curves.~      The investigators propose to collect the inhalation profiles from 20 'inhaler naïve' healthy~     volunteers after they have (a) read a typical inhaler package insert and (b) been formally~     trained in inhaler use by a pharmacist. No drug exposure will occur. The data will be used~     from this pilot study to (a) show the inter-subject variability in the inhalation profiles~     used by adults inhaling through realistic airflow resistances (like those in inhalers)~     following different types of training (b) show how formal training changes inhalation~     technique and (c) provide a database of typical inspiratory profiles for use and improvement~     of realistic tests of inhalers in the laboratory. Since pulmonary deposition from inhalers~     greatly depends upon the way patients inhale through them, this research will result in a~     database to improve the design and in vitro characterization of inhalers.~   "
164628|NCT01410864|"~     This is a non-randomized, post-approval study to further evaluate the rate of post-operative~     Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive~     DuraSeal Exact Spine Sealant System.~   "
164629|NCT01410851|"~     Pulses have the potential to be positioned as a food for body weight and metabolic control~     based on their composition, effects on rate of digestion and absorption of fat and~     carbohydrates, and effects on satiety. However, the role of individual pulses incorporated~     into a mixed meal on regulation of food intake, satiety and glycaemic control remains~     unclear. Therefore, the objective of our study was to determine the effects of ad libitum~     consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food~     intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.~   "
164630|NCT01410838|"~     This study will test whether regular consumption of Monosodium Glutamate (MSG) immediately~     prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and~     fat regain following a period of moderate, yet clinically significant weight loss.~   "
165886|NCT01394419|"~     N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump~     coronary artery bypass graft.~   "
164631|NCT01410825|"~     The Wiskott-Aldrich Syndrome (WAS) is an inherited disorder that results in defects of the~     blood and bone marrow. It affects boys because the genetic mistake is carried on the X~     chromosome. Normal people have blood cells called platelets that stop bleeding when blood~     vessels are damaged. Boys with WAS have low numbers of platelets that do not function~     correctly. Boys with WAS are thus at risk for severe life-threatening bleeding. A normal~     immune system is made of special blood cells called white blood cells, which protect against~     infection and also fight certain types of cancer. In WAS, these white blood cells don't work~     as well as they should, making these boys very susceptible to infections and to a form of~     blood cancer known as lymphoma. The abnormal white blood cells of patients with WAS also~     cause diseases such as eczema and arthritis. Although WAS can be mild, severe forms need~     treatment as early as possible to prevent life-threatening complications due to bleeding,~     infection and blood cancer.~      Over the past decade, investigators have developed new treatments based on the investigators~     knowledge of the defective gene causing WAS. The investigators can now use genes as a type of~     medicine that will correct the problem in the patient's own bone marrow. The investigators~     call this process gene transfer. The procedure is very similar to a normal bone marrow~     transplant, in that the old marrow is killed off using chemotherapy, but is different because~     the patient's own bone marrow is given back after it is treated by gene transfer. This~     approach can be used even if the patient does not have any matched donors available and will~     avoid problems such as GVHD and rejection. The investigators wish to test whether this~     approach is safe and whether gene transfer will lead to the development of a healthy immune~     and blood system.~   "
164632|NCT01410812|"~     The investigators propose that healthy behaviors such as exercise could be increased through~     the use of tying devices - mechanisms that force a coupling of addictive activities~     (listening to the next chapter of a page-turner novel) with engagement in a healthy behavior~     (exercise).~   "
164633|NCT01410799|"~     The purpose of the study is to evaluate the effect of a naturally occurring hormone, called~     Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body.~     GHRH stimulates the production of growth hormone (GH), which regulates the build up of many~     tissues in the body, including muscles and bones. Many elderly people have low levels of GH.~     The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH~     and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in~     four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass,~     physical performance, and how the body uses sugar.~   "
164634|NCT01410786|"~     The purpose of this prospective clinical data-collection is to document the performance and~     clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and~     Conventional Instrumentation.~   "
164635|NCT01410773|"~     The purpose of this study is to demonstrate that untrained subjects with diabetes can use an~     investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from~     fingerstick and from Alternative Site (AST) Palm .~   "
164636|NCT01410760|"~     The PERFORM study is a pilot study investigating the feasibility and usefulness of performing~     a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an addition to~     normal CT scanning in patients recruited to the FOXFIRE trial. All patients recruited to~     FOXFIRE at the Oxford Radcliffe Hospitals and University Hospitals of Leicester will be~     invited to take part. FOXFIRE is a national randomised controlled trial in which patients~     with unresectable liver tumours secondary to colorectal cancer will receive treatment with~     standard chemotherapy alone, or with chemotherapy in combination with an internal~     radiotherapy treatment which delivers radioactive particles(SIR-spheres) to the liver via its~     own blood supply (radioembolisation). In the FOXFIRE study a normal CT scan would usually be~     performed prior to the start of treatment and also three months after the commencement of~     treatment to assess the cancer's response to treatment, particularly whether the tumour has~     changed in size as a result of treatment. Perfusion CT gives the normal information on~     changes in tumour size but also assesses whether the blood flow to the cancer has changed,~     which may allow earlier identification of treatment success compared to normal CT scans. All~     patients consenting to participate in the PERFORM study will undergo four perfusion CT scans:~     one before the treatment starts, and one at the start of each of the second, third and fifth~     cycles of chemotherapy. The aim is to determine the feasibility of measuring tumour perfusion~     for data analysis using perfusion CT and to establish if the tumour perfusion pattern at~     baseline or shortly after the start of therapy can predict response to radioembolisation or~     chemotherapy. This research is funded by the National Institute for Health Research~     Biomedical Research Centre in Oxford and Oxfordshire Health Services Research Committee.~   "
164637|NCT01410747|"~     To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.~   "
164638|NCT01410734|"~     The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides~     real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as~     identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile~     duct (CBD). Irradiation given to the patient during a classic cholangiography can be reduced.~   "
164639|NCT01410721|"~     Up to half of all military service members with combat-related traumatic brain injury (TBI)~     also suffer from Posttraumatic Stress Disorder (PTSD). TBI and PTSD are each associated with~     cognitive problems in what are called 'executive functions' such as planning actions,~     inhibiting behavior, monitoring one's own thoughts and feelings, and solving problems~     day-to-day. These types of impairments occur more often among veterans with both TBI and PTSD~     than among those with only one of these conditions. The combination of TBI and PTSD in~     veterans has also been linked to problems with anger and violence, which are common~     complaints of veterans seeking mental health services post-deployment and have been shown to~     predict poor treatment outcomes in Iraq and Afghanistan veterans.~      Although the relationship between combined TBI/PTSD diagnoses and post-deployment adjustment~     problems has been demonstrated, there has been little research into clinical interventions~     designed to reduce the severity of cognitive and affective symptoms in veterans with both TBI~     and PTSD. Therefore, the investigators propose a randomized clinical trial involving a~     cognitive rehabilitation intervention that targets improved executive functioning, with the~     participation of N=100 veterans diagnosed with both TBI and PTSD (n=50 in experimental group~     and n=50 comparison).~      As part of the study, all participants will receive an iPod touch. Participants will be~     placed into one of the two study groups randomly. Based on which group participants are~     placed in, they will receive one of two different sets of iPod touch apps and programs that~     address and aim to improve different facets of cognitive functioning. Regardless of which~     group, Veterans will be instructed to daily practice iPod touch applications on cognitive~     functioning. Also, family members will be trained as mentors to reinforce use of the~     applications in everyday living environments. Trained facilitators will also travel to~     participants' homes to meet with veterans and family to observe behaviors in the home~     environment, arrive at strategies for applying new skills in their situations, troubleshoot~     any iPod technical problems, and review family mentoring processes.~      The investigators will measure clinical outcomes using a comprehensive array of functional~     and structural methods at baseline and six months. The investigators hypothesize improved~     executive function among those in the experimental group as well as reduced~     irritability/impulsivity and improved social/occupational functioning. The investigators~     further hypothesize that, as a group, veterans participating in the cognitive rehabilitation~     program will show significant changes in neural activity associated with executive functions~     when comparing pre- and post-treatment EEG and fMRI responses.~      Better understanding of the neural circuitry and neurocognitive function underlying executive~     function and associated affective control deficits in veterans with both TBI and PTSD, and~     how they relate to treatment outcome, will allow us to better identify therapeutic targets~     for cognitive rehabilitation. The current proposal aims to explore the relationship between~     brain function and connectivity in selective pathways/circuits, neuropsychological~     functioning, and cognitive rehabilitation response in veterans with both TBI and PTSD.~      This study of the neurobiology and neuropsychology associated with intervention efficacy will~     allow us to identify veterans with both TBI and PTSD who are predisposed to positive~     treatment outcomes. To our knowledge, this will be the first attempt to integrate~     neurobiological and neurocognitive techniques with information about the efficacy of a~     theoretically and empirically driven cognitive rehabilitation intervention in veterans with~     combined TBI/PTSD diagnoses. This research may suggest additional avenues for assessment of~     clinical intervention efficacy and the identification of therapeutic targets (e.g. alteration~     of function in fronto-limbic circuits) relevant to the military population. Given links~     between TBI/PTSD, executive dysfunction, and anger, impulsivity, and aggression, efforts to~     rehabilitate cognitive function will be particularly important to ensure that current and~     future veterans adjust successfully when they return home to their families, workplaces, and~     communities.~   "
164640|NCT01410708|"~     This study will examine the anti-tumor activity, safety and tolerability of dasatinib in~     adjuvant breast cancer patients in a pre-surgical setting.~   "
164641|NCT01410695|"~     The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to~     methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid~     arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least~     one biologic drug if patients previously failed methotrexate or to 3. methotrexate in~     combination with any DMARD including biologic drugs.~   "
164642|NCT01410682|"~     Critical care nursing interventions related to oral care can reduce the microorganisms in the~     oropharynx available for translocation to other sites. THis is a randomized, controlled and~     double blinded study performed in a pediatric intensive care unit (PICU) from a Brazilian~     university hospital which objectives were to analyze 0.12% chlorhexidine digluconate~     influence on Gram-negative pathogens colonization of oropharyngeal and tracheal secretions of~     mechanically ventilated children.~   "
164650|NCT01410578|"~     The investigators enrolled 144 subjects admitted to ICUs: 60 patients with systemic~     inflammatory response syndrome (SIRS) and 84 patients with sepsis. Tests for serum sTREM-1,~     PCT, and CRP levels and blood culture were performed on the day of admission and with the~     occurrence of FUO (>38.3ºC) during hospitalization. Based on the results of blood culture,~     the subjects were divided into bacteremia (33 patients) and non-bacteremia groups (51~     patients). Based on 28-day survival, bacteremia patients were also divided into survivor (22~     patients) and non-survivor groups (11 patients). Serum sTREM-1 and PCT levels were summarized~     as medians (interquartile ranges) and CRP levels were presented as means ± standard~     deviations. To explore the early diagnostic value of soluble triggering receptor expressed on~     myeloid cells 1 (sTREM-1), procalcitonin (PCT), and C-reactive protein (CRP) serum levels for~     identification of sepsis and bacteremia and the prognosis among patients with a fever of~     unknown origin (FUO) in the intensive care unit (ICU) and to discuss the clinical application~     of the results.~   "
164748|NCT01409304|"~     We intend to investigate whether deep transcranial magnetic stimulation (DTMS), a novel brain~     stimulation technique, is effective for treating major depression. We hypothesize that 4~     weeks of DTMS will be associated with significant improvements in depressive and anxious~     symptoms without significant side effects.~   "
164643|NCT01410669|"~     This project is a randomized trial to determine if motivational interviewing (MI) is an~     effective intervention to help women in abusive intimate relationships. The study objective~     is to motivate abused women to identify and achieve their own specific goals that can help~     them address the violence in their lives. This project will be integrated into the setting of~     a busy family planning clinic in the mid-western United States, which serves a largely rural~     population. Intimate partner violence (IPV) is screened using the Women's Experience with~     Battering Scale (WEB), a modified Abuse Assessment Screen (AAS), and the Danger Assessment~     Screen (DAS). An expected 250 women who screen positive for IPV will be enrolled, randomized~     to the intervention or to usual care group, and complete the 6-month study protocol. All~     subjects complete a self-administered computer-based questionnaire at the initial and 6-month~     follow up visits to measure self-efficacy (primary outcome), stage of readiness to change,~     selected IPV-related health correlates (e.g., depression), and steps taken and resources~     used. The MI intervention is an active listening counseling technique aimed at guiding the~     patient towards identifying feasible, personalized goals and steps she can take to increase~     her self-efficacy and control in the relationship. The trained study interviewer will work~     with participants to identify steps they can safely take and local resources to help them~     meet their goals. The MI protocol consists of a face-to-face counseling session at baseline~     with follow-up telephone interviews conducted at 1-, 2-, and 4-months post-intervention to~     reinforce the intervention and assess the participants' level safety. The control group will~     receive usual care, which includes talking with a Level 3 Domestic Violence Advocate and~     receiving a comprehensive list of domestic violence resources. Effectiveness of the MI~     intervention will be determined by increased self-efficacy, measured by the Domestic Violence~     Coping and Self-Efficacy Scale, a validated tool for use among women with a recent history of~     domestic abuse; and by a reduction in depressive symptoms (CESD-10). The impact of the~     intervention will be assessed by an increase in participants' readiness-to-change, and extent~     of their involvement in a wide variety of self-help and coping activities over the follow-up~     period. If successful, this screening and intervention program will be translated to other~     clinical settings.~   "
164644|NCT01410656|"~     The primary purpose of the study is to determine the effects of an implementation intention~     intervention on physical activity (PA) behaviour in prostate cancer survivors. Secondary aims~     are to (a) compare the effects of a telephone-assisted implementation intention intervention~     against a self-administered implementation intention intervention and a standard~     recommendation group on physical activity behaviour and (b) document the effects of these~     interventions on quality of life (QoL), fatigue, symptom management, and physical~     functioning.~      Hypotheses: Evidence exists that an implementation intention intervention can lead to~     significant improvements in PA levels and that regular PA has been shown to improve QoL,~     fatigue levels, manage symptoms and improve physical functioning in cancer survivors'. As~     such, the following hypotheses were generated: (1) prostate cancer survivors exposed to the~     researcher-assisted implementation intention intervention will have higher PA levels at the~     1- and 3-month follow-ups compared to the self-completed implementation intention~     intervention and the standard recommendation group; (2) prostate cancer survivors in the~     researcher-assisted implementation intention intervention will show significant improvements~     in QoL, fatigue levels, symptom management, and physical functioning compared to the~     self-completed implementation intention intervention and the standard recommendation group at~     the 1- and 3-month follow-up; and (3) prostate cancer survivors in the self-completed~     implementation intention intervention will have higher PA levels, and better improvements in~     QoL, fatigue levels, symptom management, and physical functioning compared to the standard~     recommendation group at the 1- and 3-month follow-ups.~   "
164645|NCT01410643|"~     Puberty represents a critical period in terms of metabolic health. Racial differences in~     insulin dynamics, reproductive maturation, and the associated endocrine changes may affect a~     female's health later in life. Further, the peripubertal period is likely the period of~     racial divergence in adiposity noted between European American (EA) and African American (AA)~     girls. Diet is a major modifiable risk factor. The identification of simple, cost-effective~     dietary strategies for prevention and management of metabolic disease and excess fat mass~     accrual during the peripubertal period is a priority. Modification of the diet to affect~     metabolic and endocrine outcomes with and without weight loss during the pubertal transition~     represents a novel approach to the pediatric obesity epidemic.~      It is likely that the two diets used in this project will have different metabolic effects,~     including effects on postprandial glycemia, triglyceride concentration, free fatty acid~     concentration, and satiety. These factors may in turn, affect development of metabolic~     perturbations, especially in susceptible individuals (e.g. AA peripubertal girls).The role of~     carbohydrates on metabolic outcomes, particularly among children, has received little~     attention. It has been hypothesized that higher postprandial glycemia may be a mechanism for~     disease progression. Development of a diet that reduces insulin secretion and optimizes~     metabolic-endocrine health among peripubertal girls will likely reduce obesity and related~     co-morbidities and future reliance on pharmacologic treatments, even in the absence of weight~     loss. However, in light of the current trends in pediatric obesity, a safe and effective~     regimen that also promotes weight loss is needed for the pediatric population.~      This proposal is significant in that it will shed light on whether diet composition, as a~     part of a eucaloric (weight-stable) or hypocaloric diet (weight-loss) can influence the~     hyperinsulinemic characteristic of AA peripubertal girls. Existing data suggest that elevated~     concentrations of insulin and/or reproductive hormones may contribute to the fat mass accrual~     in AA and could elevate risks for development of chronic diseases in adulthood. The results~     of this study will lead to the development of dietary means for the reduction of insulin, and~     thereby to the prevention of both pediatric obesity and type 2 diabetes.~   "
164646|NCT01410630|"~     A research study of a new method of visualizing internal organs called 18F-FLT PET/CT that~     yields better tracking of cancer treatment progress. PET/CT stands for positron emission~     tomography with low dose computed tomography and has been used for many years. 18F-FLT PET/CT~     uses a new tracer, fluorothymidine, which is taken up by cells that are actively~     proliferating or dividing such as cancer cells. We hope to learn whether this tracer is~     superior to the conventional tracer for monitoring treatment of diffuse large B-cell lymphoma~     (DLBCL).~   "
164647|NCT01410617|"~     Coronary artery disease is a major cause of death in patients with renal dysfunction Among~     patients who undergo coronary artery bypass grafting ,renal dysfunction is known To be a~     major predictor of in-hospital and remote mortality As little is known about the impact of~     non-dialysis-dependent renal dysfunction on short and mid term Outcomes following coronary~     surgery we have decided to investigate the effect of prophylactic Hemodialysis on the~     mortality and morbidity of the patients with ckd (stage 3,4 ) and compare these Effect with~     the control group~   "
164648|NCT01410604|"~     The purpose of this study is to compare serum concentrations of inflammatory cytokines,~     interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour~     necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese~     adolescents with insulin resistance (IR).~   "
164649|NCT01410591|"~     The purpose of this study is to determine whether transjugular intrahepatic portosystemic~     shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing~     TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal~     bleeding.~   "
164749|NCT01409291|"~     Many Americans are living paycheck to paycheck. This may lead to financial stress and an~     increase in overall stress. People under stress are more likely to smoke, consume alcohol,~     eat a poor diet, and experience depression or anxiety. Experiencing financial stress may also~     increase the risk for heart disease. The purpose of this research study is to test whether~     participating in the Financial Success Program improves health outcomes, in both the women~     participating and their children.~   "
164651|NCT01410565|"~     This is an international, multicenter, double-blind, placebo-controlled, randomized study.~     All eligible patients entering the open label phase of the study will receive a single~     immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral~     resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double~     Blind Phase qualification, patients with confirmed eligibility will be randomized to receive~     either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo~     cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients~     with histologic evidence of recurrent disease during the study will be treated according to~     current treatment guidelines or local standard of care. Safety and efficacy assessments will~     be performed at 3 month intervals for all randomized patients throughout the study. Patients~     who receive single dose of apaziquone immediately following TURBT and are not eligible for~     randomization will be followed for 3 months by cystoscopic exam and safety assessments.~   "
164652|NCT01410552|"~     ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate~     shocks, in a general population implanted for primary or secondary prevention with a dual or~     tri chamber device at one year follow-up~   "
164653|NCT01410539|"~     This study is designed to assess the pathophysiology of ST by studying the main procedural~     and anatomical factors involved in the genesis of ST such as those related to stent and the~     vascular wall, as well as to the individual platelet residual reactivity.~   "
164654|NCT01410526|"~     Protocol Synopsis~      Protocol title: Assessment of peritoneal immune response in patients with severe~     intra-abdominal sepsis managed by laparostomy and VAC~      Purpose: Assessment of peritoneal immune response in patients with severe intra-abdominal~     sepsis~      Design: Prospective, single-center study~      Patient Population: Male or female adults (>18 years) with severe intra-abdominal sepsis~      No. of Subjects: 60 patients divided into two groups, 30 patients with severe intra-operative~     sepsis and 30 patients without sepsis scheduled to undergo major abdominal operations (middle~     line incision>15cm). The study is estimated up to 2 year to enroll~      Duration of Follow-up: Follow-up will be performed daily while hospitalized, until patient~     discharged or deceased.~      Endpoints:~        1. To measure the peritoneal cytokines levels in patients with severe intra-abdominal~          sepsis.~        2. To correlate the cytokines levels in the abdominal cavity and the serum plasma.~        3. To correlate cytokines response in serum plasma and peritoneal fluid with mortality and~          morbidity.~        4. To compare cytokines results in serum plasma and peritoneal fluid between patients with~          severe intra-abdominal sepsis and patients undergoing major laparotomy without sepsis.~        5. To assess the microbial load in the abdominal cavity in patients with severe sepsis.~        6. To assess the biofilm formation in VAC polyurethane sponge.~   "
164655|NCT01410513|"~     Primary Objective:~      - To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for~     SAR245409 when administered in combination with rituximab or bendamustine plus rituximab~      Secondary Objectives:~        -  To determine the safety and tolerability of SAR245409 in combination with rituximab or~          bendamustine plus rituximab in subjects with indolent Hon-Hodgkin Lymphoma (iNHL) Mantle~          Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL)~        -  To determine the pharmacokinetics (PK) of SAR245409, bendamustine and rituximab when~          used in combination in subjects with iNHL, MCL or CLL~        -  To determine the pharmacodynamic (PD) effects of SAR245409 in combination with rituximab~          or bendamustine plus rituximab in subjects with iNHL, MCL or CLL~        -  To determine the antitumor activity of SAR245409 in combination with rituximab or~          bendamustine plus rituximab in subjects with iNHL, MCL or CLL~   "
164656|NCT01410500|"~     The purpose of this study is to expand upon the safety data for carfilzomib by providing~     expanded access to patients with relapsed and refractory multiple myeloma who are unable to~     enroll in any other ongoing carfilzomib trial.~   "
164657|NCT01410487|"~     Obesity is a medical problem of epidemic proportions and is associated with high mortality.~     Obesity has significant effects on the cardiovascular system, producing structural~     cardiovascular changes including myocardial hypertrophy, fatty infiltration, and fibrosis;~     diastolic and systolic dysfunction; changes in pulmonary artery compliance; and increased~     aortic stiffness - all of which can lead to heart failure. Indeed, evidence suggests that~     obesity increases the risk for heart disease independent of other known risk factors such as~     coronary artery disease, hypertension, diabetes mellitus, and obstructive sleep apnea.~     Obesity also causes significant changes in pulmonary function, including a decrease in~     expiratory reserve volume and functional residual capacity and closure of peripheral airways.~     The exact mechanisms for the development of cardiopulmonary disease are not well understood -~     the pathophysiology is complex and likely multifactorial, related to altered hemodynamic~     load, altered metabolic activity, underlying inflammation, and increased cardiac output.~      Newer diagnostic modalities available at our institution such as cardiac MRI and pulmonary~     function tests with impulse oscillometry allow us to better evaluate cardiopulmonary~     dysfunction in patients with severe obesity. Cardiac MRI is especially promising as a~     non-invasive imaging modality in obese individuals, providing more reproducible measurements~     of cardiac and vascular anatomy and function relative to echocardiography. Similarly,~     pulmonary function testing with impulse oscillometry is more sensitive for detection of~     abnormalities in the distal airways especially when spirometry is normal, as frequently~     occurs in the severely obese symptomatic patients. The main objective of the proposed study~     is to evaluate the effect of obesity on quality of life and health care utilization and its~     relationship to cardiopulmonary disease in an ethnically diverse, underserved obese~     population by using state-of-the-art diagnostic modalities before and after significant (20%)~     weight loss.~      The investigators propose to perform stress cardiac MRI and pulmonary function testing with~     oscillometry before and after significant surgical weight loss in 150 severely obese patients~     with cardiopulmonary symptoms. Patients evaluated in the comprehensive Obesity Center at~     Bellevue Hospital who meet NIH Consensus Guidelines for Bariatric Surgery, who have~     cardiopulmonary symptoms, and who meet clinical criteria for cardiac stress testing and~     pulmonary function testing will be approached by the study personnel and offered enrollment.~     Informed consent will be obtained. Enrolled patients will undergo clinical evaluation with a~     detailed medical history including the Borg dyspnea scale, physical examination, laboratory~     testing including cardiopulmonary biomarkers (brain natriuretic peptide, C-reactive protein,~     atrial natriuretic peptide), and non-invasive cardiovascular stress MRI and pulmonary~     physiologic evaluation including spirometry, plethysmography and impulse oscillometry (IOS).~     Patients with active smoking history and/or asthma will be identified clinically.~      Cardiovascular MRI will be performed using a 1.5T (Avanto or Espree, Siemens Healthcare)~     system. Standard cardiovascular techniques will be used for the assessment of myocardial and~     vascular structure and function, including T1-weighted, T2-weighted, late gadolinium~     enhancement, cine, tagged and phase contrast imaging in selected planes. Adenosine stress MRI~     will be performed for evaluation of underlying coronary artery or microvascular disease.~   "
164658|NCT01410474|"~     This study will evaluate the immunogenicity and safety of a single injection of Novartis~     Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.~   "
164659|NCT01410461|"~     Study aims to: (1) evaluate the role of morphological and physiological characteristics of~     the pelvic floor, pain-related psychological and -psychophysical variables in prediction of~     the success of myofascial physical therapy (MPT) for the treatment of painful bladder~     syndrome Patients with clinical symptoms of PBS will undergo physical examination, sensory~     testing in the genital area, perineal ultrasound examination for the evaluation of the length~     of the levator muscles before MPT and following 10 consecutive sessions of MPT.~      Improvement in clinical symptoms will be assessed and evaluated for correlations with~     psychophysical examinations.~   "
164660|NCT01410448|"~     The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant)~     administration of everolimus after transplantation reduces the risk of wound healing~     complications in comparison with immediate administration in de novo renal transplant~     patients (proportion of patients without wound/surgical complications related to initial~     transplant surgery) between randomization and 3 months after transplantation.~   "
164661|NCT01410435|"~     Since the duration of most studies with IV iron in IBD subjects have been only 4-12 weeks~     studies there is a need to follow-up on long term safety and efficacy of any maintenance iron~     therapy.~      This study represents subjects from the Lead-in Study (P-Monofer-IBD-01) on iron isomaltoside~     1000 (Monofer®) to assess the long term safety of iron isomaltoside 1000 (Monofer®) and its~     ability to maintain stable haemoglobin in IBD subjects with Iron Deficiency Anaemia (IDA).~   "
164662|NCT01410422|"~     Metabolomics is a large-scale approach to monitoring the compounds involved in cellular~     processes. It may reflect changes in biological function. Collection of exhaled breath is a~     newly developed, noninvasive method that may allow clinicians and researchers to assess~     biochemical profiles in the airway. This study is conducted for the metabolomic analysis of~     the exhaled gas in patients with Chronic Obstructive Pulmonary Disease (COPD) and~     bronchiectasis.~   "
164750|NCT01409278|"~     The purpose of this study is to examine three different ways to control pain after hip~     replacement:~        1. One time injection of ropivacaine before wound closure~        2. One time injection of ropivacaine before wound closure plus slow release of ropivacaine~          via catheter for 48 hours~        3. Standard practice of patient controlled pump~   "
164663|NCT01410409|"~     The purpose of this study is to test whether surgical insertion of total knee replacement~     provides further improvement in quality of life, pain and function in addition to an~     algorithm for systematic non-surgical treatment consisting of corrective insoles,~     neuromuscular training, weight loss, patient education and pharmacological treatment with~     paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the~     MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).~      The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment~     results in a greater increase in quality of life and functional capacity and greater~     reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up~     12months after the start of the treatment.~      See statistical analysis plan available under Links for further description of the study.~   "
164664|NCT01410396|"~     The aim of this study is to determine the yield of 3 weeks outpatient mobile cardiac~     monitoring for detection of atrial fibrillation in patients with history of stroke of known~     cause.~   "
164665|NCT01410383|"~     Eprotirome is a liver selective thyroid hormone that can reduce several independent risk~     factors for cardiovascular disease, while an euthyroid state is preserved in the extrahepatic~     tissue.~      The purpose of this Phase III study is to assess the long-term efficacy and safety of~     Eprotirome in Patients with heterozygous Familial Hypercholesterolaemia who are on optimal~     standard of care.~   "
164666|NCT01410370|"~     The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar~     infusion combined with radiotherapy for treatment of brain metastases.~   "
164667|NCT01410357|"~     This project tests a model for improving illness self-management among persons who have both~     serious mental illness and diabetes and will be performed within a primary care setting at a~     safety net hospital system. The information gained from the randomized trial will be~     supplemented with reports from participants about their experiences of trying to improve~     illness self-management. Improvements in self-management should result in a reduction of~     psychiatric symptoms and improvements in functioning and physical health.~   "
164668|NCT01410344|"~     The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT~     for patients with chemotherapy-sensitive hematological malignancies and coincident~     HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an~     indicator of the safety of transplant in this patient population. Correlative assays will~     focus upon the incidence of infectious complications in this patient population, the~     evolution of HIV infection and immunological reconstitution. Where feasible (and when this~     can be accomplished without compromise of either the donor quality or the timeliness of~     transplantation), an attempt will be made to identify donors who are homozygotes for the~     delta32 mutation for CCR5.~   "
164669|NCT01410331|"~     This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy~     of JVS-100 given to adult subjects with critical limb ischemia (CLI).~   "
164670|NCT01410318|"~     The overall objective of this study is to characterize the prevalence and progression rate of~     subclinical atherosclerotic lesions and to study their association to the imaging~     characteristics of atheroma plaques and to the presence of genetic, epigenetic, metabolomic,~     and environmental factors, including dietary habits, physical activity, biorhythms,~     psychosocial characteristics, and exposure to environmental pollutants~   "
164671|NCT01410305|"~     The relationship of Vitamin D levels in children and young adults to atherosclerosis.~   "
164672|NCT01410292|"~     The aim of this study is to assess the post-prandial response of four breakfast with~     different content of dietary fiber and glycemic index on glycemic response and satiety in~     patients with type 2 diabetes.~   "
164673|NCT01410279|"~     The purpose of this study is evaluate the effect the inspiratory muscle training on the~     functional capacity of patients with pulmonary hypertension.~   "
164674|NCT01410266|"~     The purpose of this study is to determine whether an alternative method of follow-up after~     medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.~   "
164675|NCT01410253|"~     Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on~     recovery of functional capacity, pulmonary function and respiratory muscle strength in the~     period of hospital stay after coronary artery bypass graft.~   "
164676|NCT01410240|"~     The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of~     care for hemostasis in subjects undergoing total knee arthroplasty.~   "
164677|NCT01410227|"~     The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF,~     and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding~     events in subjects with severe hereditary von Willebrand disease (VWD).~   "
164678|NCT01410214|"~     The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus~     cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete~     resection with EGFR activating mutations and to explore a new treatment strategy for this~     subset.~   "
164679|NCT01410201|"~     The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant~     (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic~     epiretinal membrane (ERM).~   "
164680|NCT01410188|"~     This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in~     the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in~     subjects with primary open-angle glaucoma or ocular hypertension.~   "
164691|NCT01410045|"~     Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular~     apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation~     has been used in an effort to preserve fertility in patients undergoing treatments which lead~     to premature and severe ovarian insufficiency. This study aims to assess the relevance of~     ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular~     density as primary outcome and karyotypic, clinical and hormonal markers as secondary~     outcomes, analysis of the study will allow to select the patients to whom the procedure would~     benefit the most.~   "
164692|NCT01410032|"~     The purpose of this study is to compare the clinical and radiographic results of patients~     with midshaft clavicular fractures treated with plates or intramedullary flexible nails~     fixation.~   "
164681|NCT01410175|"~     Surgical site infection (SSI) is the second commonest hospital infection, despite advances in~     prevention that have been achieved.~      According to Fernàndes, experimental studies have demonstrated that incorrect use of electric~     scalpels may double the rate of SSI during electrocauterization.~      Because of the lack of solid data in the literature, in relation to the impact on SSI of~     using electric scalpels for making incisions in the skin and all subcutaneous tissues, it was~     judged to be opportune to conduct the present study.~      Objectives:~        -  To compare the incidence of SSI and other complications of the operative wound among~          patients undergoing elective abdominal gynecological surgery at Barretos Cancer~          Hospital, between the use of electric and cold scalpels.~        -  To identify the incidence of SSI and other complications of the operative wound among~          patients undergoing elective abdominal gynecological surgery, when using electric~          scalpels for skin incisions and for subcutaneous incisions.~        -  To identify the main risk factors for SSI among patients undergoing elective abdominal~          gynecological surgery.~   "
164682|NCT01410162|"~     Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or~     twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal~     allograft function, other relevant biochemical parameters and treatment related adverse~     effects.~   "
164683|NCT01410149|"~     Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights of~     polysomnography to record sleep patterns while receiving three modes of mechanical~     ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV),~     Assist control ventilation (ACV), applied in random order. The purpose is to determine the~     effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.~   "
164684|NCT01410136|"~     The overall study objective is to evaluate Chondrofix Osteochondral Allograft (Chondrofix)~     for the repair of osteochondral lesions in the knee. This includes, but is not limited to~     primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The~     study hypothesis is that Chondrofix Allograft will provide pain relief and functional~     improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24~     months of follow-up.~   "
164685|NCT01410123|"~     The study is a series of 3 linked randomized clinical trials of 6 month duration, with a~     total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking~     outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with~     unhealthy alcohol use.~   "
164686|NCT01410110|"~     The initial phase of substance abuse treatment is a vulnerable period for relapse. Cognitive~     impairments are common during this phase and may reduce the ability to benefit from other~     forms of substance abuse and rehabilitation services. The study compares a rehabilitation~     program that combines work therapy with computer-based cognitive training of attention,~     memory and executive functions to work therapy alone in a 3 months outpatient substance abuse~     program. It is hypothesized that cognitive training will increase days of sobriety during the~     active intervention and better substance abuse outcomes at 6 month follow-up.~   "
164687|NCT01410097|"~     Obesity is associated with physical disability through both direct pathways (e.g., lower~     extremity pain, insufficient muscle strength) and indirect pathways (obesity-related~     comorbidities and inflammation). Furthermore, diabetes, a major obesity-related health~     condition, is associated with increased risk of disability and accelerated declines in~     physical and cognitive function. The investigators preliminary data suggest that intentional~     weight loss improves physical function, and there is strong circumstantial evidence that it~     would also benefit cognitive function.~      To evaluate the role of intentional weight loss on physical and cognitive function, the~     investigators propose an ancillary study to the on-going Look AHEAD (Action for Health in~     Diabetes) trial. Look AHEAD is a multi-center, randomized clinical trial to examine the~     effects of a 4-year lifestyle intervention designed to achieve and maintain weight loss~     through decreased caloric intake and exercise in overweight or obese men and women aged 45-74~     years with type 2 diabetes. The investigators propose to add validated and well-established~     measures of physical and cognitive performance to the year 8 follow-up visit - during the~     trial's weight maintenance phase - in ~1000 participants at 4 of the 16 Look AHEAD field~     sites (Colorado, Memphis, Pennington and Pittsburgh).~      The specific aims of this ancillary study are: 1) To determine the long-term effects of a~     lifestyle intervention designed to achieve and maintain weight loss on physical function; and~     2) To determine the long-term effects of a lifestyle intervention designed to achieve and~     maintain weight loss on cognitive function. In addition, the investigators hypothesize that~     in the intervention group, larger initial weight loss, better weight loss maintenance, and~     higher physical activity will be associated with better physical and cognitive function. The~     investigators also hypothesize that in the control group weight loss will be associated with~     worse physical and cognitive function than in those who are weight stable or who have gained~     weight.~      The number of obese older adults is rising rapidly and there are few data to guide an~     evidence-based clinical response to their management. The results of this study will provide~     the first direct evidence of the role of long-term intentional weight loss on the maintenance~     of physical and cognitive function in older obese adults with diabetes. Since this study is~     being done as an ancillary study to an on-going trial it can be done in a timely and~     cost-efficient manner.~   "
164688|NCT01410084|"~     In the past two decades, the role of vitamin D has extended beyond bone health to encompass a~     wide range of biological activities important to physical function in older adults. A growing~     body of evidence now shows that circulating 25-hydroxyvitamin D (25(OH)D) levels < 75 nmol/L~     (< 30 ng/mL)) are associated with physical impairments such as reduced walking speed and~     impaired balance as well as falls. Older adults are at risk for low levels of~     25-hydroxyvitamin D because of reduced exposure to ultraviolet B radiation, reduced~     efficiency of previtamin D synthesis in the skin, and low dietary intake. Although data from~     the National Health and Nutrition Examination Survey (NHANES) 2000-2004 indicate that frank~     vitamin D deficiency (serum 25(OH)D < 25 nmol/L [10 ng/mL]) is rare in the U.S. (5% or less),~     vitamin D insufficiency (serum 25(OH)D < 75 nmol/L [30 ng/mL]) is prevalent (~75%) among~     older adults. Older home-bound adults are a vulnerable subgroup of older adults for poor~     dietary intake and nutritional health, nutrition-related health conditions, and functional~     decline and disability. The primary goal of this pilot study is to assess the feasibility of~     a partnership with Senior Services of Forsyth County to address vitamin D insufficiency in~     home-bound older adults receiving home-delivered meals. A secondary goal is to obtain~     preliminary data on the effectiveness of vitamin D supplementation on improving vitamin D~     levels and reducing falls.~   "
164689|NCT01410071|"~     The purpose of this research study is to see if there is a significant difference in~     improvement of symptoms and quality of life of those undergoing endoscopic therapy versus~     those wanting to control their symptoms with medicines or those who just want to wait and~     watch.~   "
164690|NCT01410058|"~     A study will be conducted by scientists from the University of Zimbabwe to determine if~     antiretroviral drugs are affected by taking herbs at the same time. This is important because~     herbal medicines may interact with modern medicine to increase or decrease the amount of~     medication in the body.~      The drugs nevirapine and efavirenz will be studied. Both drugs are routinely used as part of~     combination therapy for treating HIV. In this study it will be determined whether the~     concentrations of the antiretroviral drugs nevirapine and efavirenz are low, high or are in~     the desired range when taken together with the herb moringa.~   "
164694|NCT01410006|"~     The Neurofibromatosis Type 1 (NF1) Patient Registry Initiative (NPRI) is a web-based registry~     that asks participants to fill out a 30-minute online questionnaire to collect information~     about the spectrum of medical and social problems experienced by children and adults with~     NF1. The information gained from your participation may one day help doctors develop~     personalized treatments for individuals living with NF1.~      We are currently enrolling individuals with NF1 who either (1) HAVE previously been diagnosed~     with a brain tumor younger than 18 years or (2) HAVE NEVER had a brain tumor. Please note:~     there is no therapy associated with this study. Individuals may participate in the registry~     by going to https://nf1registry.wustl.edu/~   "
164695|NCT01409993|"~     The purpose of this study is to determine the effect of chronic PDE5 inhibitor therapy on~     glucose metabolism in persons with prediabetes.~   "
164696|NCT01409980|"~     A triphalangeal thumb is a thumb with three phalanges. The thumb often appears long and~     fingerlike, and can sometimes be in the same plane as the other fingers. Anatomically, the~     extra phalanx can have different shapes. Several classification systems have been used, but~     the simplest and most often used is the Wood (1976) classification by the shape of the extra~     phalanx. If the extra phalanx is triangularly shaped it is classified as a type I. Type II~     has a rectangular shaped extra phalanx but it has not developed as a full phalanx. Type III~     is a full extra phalanx.~   "
164697|NCT01409967|"~     The aim of this work is to study the changes of key assays useful for the understanding of~     anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays,~     hemolysis markers.~   "
164698|NCT01409954|"~     The purpose of this study is to improve fusion (bony healing) techniques and improve patient~     recovery by identifying cells in your body that make bone. Patients with spine problems often~     need surgeries that include fusion (bony healing) of vertebrae (bones in your back) together~     in order to hold the bones steady allowing them to heal together (fusion). If the vertebrae~     (back bones) fail to heal together, which occurs about 10-15% of the time, it can result in a~     slower recovery and may require revision (another) surgery. By using a small portion of the~     graft taken during surgery the investigators hope to define the cells that make bone most~     efficiently. This will help reduce the need for revision surgeries and improve patient~     recovery.~   "
164699|NCT01409941|"~     Cerebral oxygen saturation (ScO2) is a measure of cerebral and systemic oxygen delivery to~     demand ratio. An observational trial in a heterogeneous cohort of 1078 patients patients~     revealed that a ScO2 below 50% absolute during oxygen insufflation is an independent~     predictor of short and long term mortality in patients undergoing on-pump cardiac surgery.~     Comparably, a low ScO2 was a predictor of postoperative morbidity determined as a combined~     endpoint of a high dependency unit stay of more than 9 days and/or at least 2 of the major~     postoperative complications. low cardiac output syndrome, stroke, need of renal replacement~     therapy or reintubation.~      The primary objectives of the present prospective observational study is to determine, if~     there is an association between preoperative ScO2 and postoperative organ dysfunction~     determined by sensitive markers of organ dysfunction (N-Terminal pro B-type natriuretic~     peptide, high sensitive troponin T, growth-differentiation factor 15, soluble -FLT1, and~     placental growth factor)~   "
164700|NCT01409928|"~     This is a prospective, non-randomized, single center study of a laparoscopically placed,~     adjustable gastric band medical device for the treatment of adolescent obesity.~   "
164701|NCT01409915|"~     A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested~     for its ability to be tolerated by Alzheimer's disease patients and potentially to improve~     their memory.~   "
164702|NCT01409902|"~     The main objective of the study is to assess the effectiveness of the sheathed speculum in~     providing adequate visualization and access to the cervix in patients with excessive vaginal~     tissue.~      The secondary objective is to rate the patient's comfort evaluation during the sheathed~     speculum examination.~   "
164703|NCT01409889|"~     The purpose of this study is to compare the effectiveness and costs of two programs,the~     Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in~     an primary care practice.~   "
164704|NCT01409876|"~     This is a phase II trial looking at the feasibility of HistoScanning- based dose-painting~     image- guided interstitial brachytherapy in non- metastatic prostate cancer~      Endpoints:~      Primary endpoint Evaluation of the feasibility of HistoScanning- based dose-painting image-~     guided interstitial brachytherapy~      Secondary endpoints~        1. Evaluating tumor response using HistoScanning~        2. Evaluating locoregional recurrence rates by measuring PSA~        3. Analysis of the correlation between tumor response as determined by HistoScanning and~          PSA response~        4. Evaluating the safety dose-painting image- guided interstitial brachytherapy by~          recording serious adverse events~   "
164705|NCT01409863|"~     The goals of this study will be to compare the safety and efficacy of fractional~     photothermolysis (Fraxel) with dermabrasion when used for scar revision.~   "
164706|NCT01409850|"~     The most commonly applied treatment against acute temporomandibular signs and symptoms is~     pharmacotherapy. The evidence on treatment efficacy of non-medication treatments (like~     splints) is very low. Two very commonly used splints are the Aqualizer® and the soft~     polyester splint. These are splints applied for a short period of time, until the treatment~     with a hard splint and/or physiotherapy begins. Aim of this study is to compare the clinical~     short-time efficacy of these two splints for the treatment of acute temporomandibular pain~     and compare it to a control group receiving no therapy for that short time.~      The study hypothesis is that there is a difference in pain reduction between the three groups~     of patients (two intervention and one control group).~   "
164719|NCT01409681|"~     Vitamin D exerts antiproliferative and differentiating effects in cancers, including~     non-small cell lung cancer (NSCLC). The active form of Vitamin D is 1,25,~     dihydroxycholecalciferol (calcitriol) which rapidly induces expression of cytochrome P450~     24R-hydroxylase (CYP24A1). CYP24A1 initiates inactivation of calcitriol as a result of~     successive hydroxylation/oxidation reactions. This study seeks to prospectively determine the~     relationship between Vitamin D gene expression and median survival as a primary outcome, and~     between the Vitamin D receptor (VDR)/CYP24A1 gene expression and cancer stage, smoking~     status, serum 1,25 (OH)2D3 levels as well as CYP24A1 genotype.~   "
165887|NCT01394406|"~     Ketamine added to intravenous patient-controlled analgesia may be effective on prevention of~     postoperative nausea and vomiting by reducing opioid requirement after surgery.~   "
164707|NCT01409837|"~     This study was conceived in order to explain what the investigators previously observed~     suggesting that lisinopril, a drug normally used to treat patients with high blood pressure~     and heart failure, may be effective in treating infertile men with low sperm count. The~     investigators hypothesized, therefore, that the drug will not only improve sperm quantity and~     quality but also increase the fertility in such patients. The investigators first of all~     reviewed the results of previously published investigations and found out that there was only~     a few previous studies done in humans.with this class of drugs. Besides, the methods used in~     conducting most of those studies have been so faulted that the results cannot be trusted to~     be showing the true picture. The investigators looked at the various faults pointed out with~     respect to the their design and conduct and took care of them while designing the~     investigators own study. This was an attempt to provide more credible answers to the question~     of whether lisinopril, and possibly other drugs of similar mode of action, can be useful in~     rectifying the problem of infertility caused by low sperm count and , if so, whether it will~     be safe to use it in people who do not have high blood pressure or heart failure. In order to~     achieve this the investigators studied 33 patients with sperm of low cell concentration, low~     percentage of motile cells and high percentage of abnormal cells from no known cause. The~     patients were randomly allocated to receive either lisinopril 2.5mg daily (17 patients) or~     daily placebo (16 patients)and their sperm characteristics were examined at intervals,~     starting from the beginning of the study until when it ended 282 weeks later. The patients~     were also monitored for adverse events throughout the period. The data form all the patients~     that took part in the random allocation of treatments at the beginning of the study were~     included in the analysis that followed, irrespective of whether they completed the study or~     not.~   "
164708|NCT01409824|"~     Besides a dramatic lack of financial and human resources in developing countries, health care~     is additionally endangered by quality deficiencies caused by low staff motivation. This lack~     of motivation leads to an insufficient translation of knowledge into optimal utilization of~     resources. The know-do gap represents a challenge that must be addressed to strengthen~     health services performance towards achieving the Millennium Development Goals (MDGs). This~     is in particular true for some sensitive sectors like pre-natal and maternal health care.~     General objective of this research is to improve maternal health through better pre-natal and~     maternal care services offered by better motivated health workers. A computer-assisted~     clinical decision support system (CDSS) will be developed, implemented and tested aiming at~     (I) quality improvement of maternal and newborn care and (II) assessment of provider's~     performance. Based on this tool a commonly agreed incentive scheme to increase motivation~     will be shaped and tested in three SSA - countries, namely Burkina, Ghana, and Tanzania.~      The incentive scheme might contain both non-monetary and monetary incentives and will be~     designed according to the human resource policy in the three countries. The planned approach~     is an implementation study with control arms containing one hospital and 6 first line health~     facilities in each of the study districts and an equal number of facilities in the control~     arm. A set of indicators for measurement of changes in quality of delivered services will be~     identified in order to follow up the sustainability and effectiveness of the strategies after~     their implementation. The study findings will allow understanding the important factors of~     staff motivation and facilitate adequate management for improvement of maternal and neonatal~     health care. Knowing is not enough, we must apply; Wanting to do, is not enough, we must do~     it1~      - J.W. v. Goethe~   "
164709|NCT01409811|"~     This pilot clinical trial studies biomarkers in tissue samples from patients with newly~     diagnosed breast cancer treated with zoledronic acid (ZA). Studying samples of tumor tissue~     in the laboratory from patients receiving ZA may help doctors learn more about the effects of~     ZA on cells. It may also help doctors understand how well patients respond to treatment.~   "
164710|NCT01409798|"~     The purpose of this registry is to create a database that collects clinical data to improve~     knowledge about primary hyperparathyroidism.~   "
164711|NCT01409785|"~     The goal of this study is to compare the LMA Unique and LMA Supreme in children having~     surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior~     to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure~     at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view,~     feasibility of use, and complications (airway related, gastric insufflation, trauma) will~     also be assessed.~   "
164712|NCT01409772|"~     The purpose of this study is to evaluate the clinical practice of the prophylactic use of~     ethanol locks for the prevention of catheter related blood stream infections in pediatric~     intestinal rehabilitation program patients requiring total parenteral nutrition.~   "
164713|NCT01409759|"~     Objective: to evaluate the perforator based interposition plasty in comparison to the~     standard technique (full thickness graft) for scar contracture releases.~      Study design: A randomised controlled multicentre intervention study.~      Study population: Patients, aged 18 years and older, who require surgery for release of a~     scar contracture, are eligible for this study. In total 50 patients will be recruited with a~     follow-up of 3 months post-operatively.~      Intervention: A release of the contracture will be performed in combination with òr the~     standard technique (full thickness graft) òr the perforator based interposition plasty.~      Main study parameters/endpoints: the main study parameter is the amount of contraction of the~     flap/graft after three months.~   "
164714|NCT01409746|"~     The purpose of this study is to study the role of genes and environment in early brain~     development using a twin approach. The investigators will use magnetic resonance imaging~     (MRI) to study brain structure and it's relationship to cognitive development. Specifically,~     the investigators will study cortical gray and white matter volumes, volumes of subcortical~     structures and cerebellum, as well as diffusion properties in major white matter tracts using~     DTI tractography.~   "
164715|NCT01409733|"~     The Aim is to evaluate safety and efficacy of TACE with doxorubicin-loaded DC beads in~     melanoma patients with liver metastasis. This is a pilot study with the aim of recruiting 20~     patients, this is a feasibility study. the patients profile is patients with stage IV~     Melanoma with liver metastases.~   "
164716|NCT01409720|"~     Standard indications for palliative radiation of bony metastases include pain, spinal cord~     compression, and impending pathologic fractures.~      Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid~     complications. Tailored training of the paravertebral musculature may support radiation~     therapy and improve above named factors. DISPO was designed to investigate the impact of~     tailored physical exercise in patients with vertebral metastases as compared to manual~     therapy (massage etc.). The trial includes patients with painful bony metastases, patients~     with spinal cord compression or impending pathological fractures are excluded. The~     investigations are carried out in a prospective randomized controlled phase-II parallel group~     design.~   "
164717|NCT01409707|"~     The purpose of this study is to test if provision of an effective psychotherapy for~     Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol~     dependent patients with PTSD and if it is associated with better treatment outcomes compared~     to an active control condition.~   "
164718|NCT01409694|"~     The purpose of this study is to compare the effect after 24 weeks of the oral intake of~     vitamin D3 (cholecalciferol) with the effect of a placebo on the change of cognitive~     performance in patients suffering from moderate Alzheimer's disease or related disorders~     (ADRD) and receiving memantine.~   "
165888|NCT01394393|"~     Participants 60 Patients seeking treatment at the Obesity Unit of the Medica Sur Hospital in~     México City, Mexico. Informed consent to participate will be aleatory assigned to a three~     different conditions.~      Procedures In the initial interview, prospective participants will be provided with detailed~     information about the study and the treatments. All patients included in the study will be~     randomly assigned to the one (N=20) of the three treatment conditions described below, all~     conducted on an inpatient basis. The duration for all treatments will be 6 weeks and will be~     administered by two chartered clinical psychologists and one chartered psychotherapist under~     the supervision of a senior chartered psychotherapist. The three therapists will be balanced~     among the three conditions.~        1. Nutritional groups In this condition (NT) the participants (N=20) subjects enter only 5~          weekly nutritional groups held by dieticians based on the LEARN manual (Brownell, 1985),~          whose goal will be to provide practical guidelines for the self-monitoring of eating and~          lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction~          achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day)~          and physical training (30 min of walking two times a week as a minimum).~        2. Cognitive-Behavioral therapy CBT group (N=20) will be based on the same treatment~          proposed in the first condition plus 15 additional sessions over 6 weeks.~           Therapists will follow a detailed manual that outlined the content of each session. This~          manual was based on the cognitive—behavioral treatment approach described by Cooper and~          colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a~          year of intensive pilot work and adapted to the in-patient setting. Patients will be~          taught to self-monitor their food intake and eating patterns and thoughts, as well as~          the circumstances and environment surrounding eating (e.g. whether eating alone or with~          others, speed of eating, and place of eating). Patients will also be taught to identify~          problems in eating, mood, and thinking patterns and to gradually develop alternative~          patterns.~           In particular, after the first week the patients will enter 5 weekly group sessions~          aimed at addressing weight and primary goals, and 10 biweekly individual sessions aimed~          at establishing and maintaining weight loss, addressing barriers to weight loss,~          increasing activity, addressing body image concerns and supporting weight maintenance.~        3. Experiential Cognitive therapy Experiential CT group (N=4) involved the same treatment~          proposed in the first condition plus 15 additional sessions over 4/6 weeks.~      In the sessions we will use the 20/20/20 rule. During the first 20 minutes, the therapist~     focus on getting a clear understanding of the patient's current concerns, level of general~     functioning, and the experiences related to food. This part of the session tends to be~     characterized by patients doing most of the talking, although therapist guides with questions~     and reflection to get a sense of the patient's current status. The second 20 minutes is~     devoted to the virtual reality experience. During this part of the session the patient enters~     the virtual environment and faces a specific critical situation (Kitchen, Supermarket, Pub,~     Restaurant, Gymnasium, etc.). Here the patient is helped in developing specific strategies~     for avoiding and/or coping with it. In the final 20 minutes the therapist explores the~     patient's understanding of what happened in VR and the specific reactions - emotional and~     behavioral - to the different situations experienced. If needed, some new strategies for~     coping with the VR situations are presented and discussed. To support the empowerment~     process, the therapists follow the Socratic style: they use a series of questions, related to~     the contents of the virtual environment, to help clients synthesize information and reach~     conclusions on their own.~      In accordance with informed consent, assessments will be obtained before treatment, at~     posttreatment, 3 and 6 months after the treatment conclusion.~   "
164721|NCT01409655|"~     Our proposal Centralized Off-Site Adherence Enhancement Program or CARE will develop and~     test an effective behavioral adherence intervention program for HIV patients with alcohol~     and/or substance abuse problems. This project will develop and pilot test a novel program to~     help patients with alcohol and/or substance abuse problems take their medications as~     prescribed. The intervention will be delivered by phone, and utilize electronic monitoring of~     medication-taking, so patients can be treated by therapists from any geographic distance. To~     safely monitor data collected for this study, we have laid out a detailed Data Safety~     Monitoring Plan, which will cover all the issues required by NIDA.~   "
164722|NCT01409642|"~     Pediatric obsessive compulsive disorder (OCD) is a chronic, impairing condition that accrues~     significant concurrent and long-term risk to affected youth (Piacentini et al. 2003; Pine et~     al. 1998). Although a host of pharmacological and psychosocial treatments have proliferated~     over the past decade (Barrett et al., 2008), many youth fail torespond to treatment and many~     who do respond continue to exhibit lingering symptoms and impairment. Thus, there is still~     much to be done by way of optimizing treatment outcomes for pediatric OCD.~      Increasingly, efforts to improve existing treatments have focused on aspects of the family~     environment that may affect treatment adherence and the maintenance of therapeutic gains.~     Such work suggests that parental accommodation and criticism are common characteristics of~     the home environment for both adults and children with OCD (Calvocoressi et al., 1999; Peris,~     Roblek, Langley, Chang, McCracken, & Piacentini, 2008; Van Noppen et al., 1991) and that, in~     adult samples, these family features are associated with poorer treatment outcome and greater~     risk of relapse (Amir, Freshman, & Foa, 2000; Chambless & Steketee, 1999;Leonard et al.,~     1993). These family-level variables are logical targets for intervention, particularly among~     treatment refractory groups of youth with OCD. However, they often are unaddressed in extant~     interventions.~      The current study tests a novel intervention that specifically targets family accommodation~     and conflict in an effort to foster an environment that supports a graded exposure approach~     to treatment. The proposed treatment, Positive Family Interaction Therapy (PFIT), is composed~     of an innovative blend of techniques that address several potential barriers to treatment.~     First, the treatment is guided by the specific needs of youth with OCD and their families~     (e.g., accommodation, conflict). The first phase of the proposed study will involve an open~     case series in order to assess the utility of the PFIT protocol and feasibility of training~     other therapists and using the manual with a range of patient presentations. The second phase~     will involve a small controlled feasibility trial evaluating the extent to which recruitment,~     randomization, and implementation of the control condition are viable for further study. It~     is hypothesized that the PFIT treatment will be feasible to implement and will yield higher~     levels of patient satisfaction compared to treatment as usual.~   "
164723|NCT01409629|"~     Study of activity choices after playing a computer game.~   "
164724|NCT01409616|"~     The primary objective of this study is to evaluate whether ASA, the combination of ASA and~     clopidogrel, and darexaban, which have different effects on blood coagulation, influence each~     other in their effects. Also it will be investigated whether the blood levels of either drug~     are influenced by the presence of the other drug. In addition, the safety and tolerability of~     each drug and the combination of the drugs will be investigated.~   "
164725|NCT01409603|"~     The primary objective of this study is to evaluate whether naproxen and darexaban which have~     different effects on blood coagulation influence each other in their effects. Also it will be~     investigated whether the blood levels of either drug are influenced by the presence of the~     other drug. In addition, the safety and tolerability of each drug and the combination of the~     drugs will be investigated.~   "
164726|NCT01409590|"~     In this study the investigators will recruit patients with the diagnosis of schizophrenia~     that are taking atypical neuroleptics and that are willing to participate in an exercise and~     diet program. The investigators will measure weight and abdomen circumference.~   "
164727|NCT01409577|"~     The investigator will evaluate the clinical outcomes of the patients in whom the treatment~     strategy for their coronary stenosis were determined by fractional flow reserve measurement.~   "
164728|NCT01409564|"~     The purpose of this study is to examine the effects of cilostazol augmentation in mild to~     moderate Alzheimer disease patients with subcortical white matter hyperintensities (WMHI)~     treated by donepezil.~      Dementia is the most disabling disease in the old age. The prevalence of dementia is 5-10% of~     the elders. AchEIs (donepezil, galantamine, rivastigmine) are used to treat mild to moderate~     dementia, but these drugs only relate to symptomatic improvement and the response rates are~     less than 30%.~      Cilostazol is a cyclic adenosine monophosphate phosphodiesterase 3 inhibitor (PDE3I) and used~     as antiplatelet agent in subcortical vascular disease (WMHI). And it upregulates~     phosphorylation of cyclic adenosine monophosphate-pathway response element binding protein~     (CREB) which plays a crucial role in memory enhancement and synaptic plasticity related to~     neurodegeneration prevention.~      The investigators will try cilostazol augmentation in dementia patients with WMHI receiving~     donepezil to see the addictive effects of cilostazol using cognitive tasks and PET imaging.~   "
164729|NCT01409551|"~     Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural~     effusions, in terms of safety and efficacy.~   "
164730|NCT01409538|"~     This study examines the brain activation associated with placebo pain reduction.~   "
164731|NCT01409525|"~     The purpose of this observational, exploratory study in patients undergoing any cardiac valve~     replacement or repair is to assess the rate of bacterial colonization over native~     degenerative calcified cardiac valves.~   "
164732|NCT01409512|"~     The aim of the study is to evaluate changes in autonomic nervous system following treatment~     with anticholinergic medication for OAB symptoms.~      Heart variability as a measure of the functioning of the autonomic nervous system will be~     recorded before and three months following treatment with solifenacin succinate 10 mg daily.~   "
164733|NCT01409499|"~     The standard treatment choice for advanced hepatocellular carcinoma (HCC) is sorafenib, and~     its efficacy is limited. More active treatments were performed in patients with advanced HCC~     in China, which include radical hepatectomy or TACE. The study is to investigate whether the~     active treatment will profit survival of patients, and to evaluate the safety.~   "
164734|NCT01409486|"~     The aim of the study is:~      to develop a comprehensive biochemical assay for detection of Pompe disease (glycogen storage~     disease type II), to be implemented in the Newborn screening program among the Israeli~     population.~   "
164735|NCT01409473|"~     The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT)~     with simultaneous boost (higher radiation dose) to areas within the prostate with more~     prominent cancerous growth (intraprostatic lesions) utilizing intensity modulated~     radiotherapy (IMRT) planning techniques is a safe and effective treatment in patients with~     low- and intermediate-risk localized prostate cancer.~   "
164736|NCT01409460|"~     The purpose of this study is to evaluate how many patients require the addition of the~     obturator nerve block in the recovery room after the total knee surgery. Also to study the~     efficacy of blocking the obturator nerve in controlling their knee pain.~   "
164738|NCT01409434|"~     This is a research study of the long term effects on blood sugar and cholesterol of blood~     pressure lowering medications. People are invited to participate in this research study if~     they participated in the Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR 1,~     NCT00246519 or PEAR 2, NCT01203852) study and are still taking a thiazide diuretic. In PEAR,~     the effects on blood pressure, blood sugar, and cholesterol of the high blood pressure drugs~     hydrochlorothiazide and atenolol over an 18 week period were evaluated. This PEAR follow-up~     study will determine the effects of thiazide diuretics on blood sugar and cholesterol, but in~     the period since the PEAR trial. The study hypothesis is that long term exposure to thiazide~     diuretics results in larger increases in blood sugar and cholesterol levels than short term~     exposure.~   "
164739|NCT01409421|"~     The investigators are studying motivational interviewing (MI). MI is a counseling method to~     help people adopt healthy behaviors. The investigators will test whether MI improves~     patients' accurate use of glaucoma eye drops. The investigators will train eye clinic staff~     called glaucoma educators to use MI. Up to 250 patients at 3 clinics will be recruited. All~     patients will receive their usual eye care. Based on chance, some patients will also be~     supported by a glaucoma educator. The groups will be compared on medication adherence using~     micro-electro-mechanical system(MEMS). MEMS are electronic bottle caps that track when a~     medication bottle is opened. Patients will be aware that their medication use is tracked. The~     groups will also be compared on treatment value, outcomes, and cost. The investigators will~     also collect data on variables that may predict medication adherence.~   "
164740|NCT01409408|"~     Assess if aliskiren is capable of enhancing vascular stiffness and endothelial function and~     compare theses effects and renin activity and concentration to those obtained with a calcium~     channel blocker, amlodipine, in patients with diabetes mellitus type 2 and blood pressure not~     controlled by 100 mg per day of losartan.~   "
164741|NCT01409395|"~     This study will address the following question: Does nizatidine affect the pharmacokinetics~     of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated~     that nizatidine may block metformin elimination from the kidney by inhibiting organic cation~     transporter efflux of metformin. The investigators hypothesize that the co-administration of~     metformin and nizatidine will reduce the renal clearance (CLR) of metformin leading to~     increased plasma concentrations and potential risk for toxicities. Knowledge of the~     pharmacokinetic interaction profile of metformin with organic transporter inhibitors, such as~     nizatidine, is important to help develop safer more effective drug therapy with reduced side~     effects.~   "
164742|NCT01409382|"~     tPA has a pivotal role in placentation, mediationg activation of growth factors, such as~     vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of~     extracellular matrix and basement membrane (directly or through activation of matrix~     metalloproteinases) and formation of hemidesmosomes.~      A high-carbohydrate intake combined with lack of physical activity provides a strong stimulus~     for maternal insulin production. In this scenario, either β-cells are dysfunctional and~     diabetes supervenes, or excessive amounts of insulin are produced, providing pathological~     stimulation of PAI-1 synthesis. Given that PAI-1 is a major tPA inhibitor, PAI-1 excess may~     affect placentation, increasing the risk of first trimester losses, preterm deliveries and~     intrauterine growth restriction.~      Our hypothesis was that prematurity was not the cause of neonatal hypoglycemia, but a~     parallel occurrence of a strong stimulus for maternal, fetal and neonatal production of~     insulin.~   "
164743|NCT01409369|"~     This open-label, two period crossover study will evaluate the effect of multiple doses of~     activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy~     volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated~     by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with~     the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period~     2, only a single dose of RO4995819 but no activated charcoal will be administered.~   "
164744|NCT01409356|"~     Overweight/obesity is increasing both in the general population and in patients with~     cirrhosis. In compensated patients with cirrhosis increased BMI is a risk factor for clinical~     decompensation independent of liver function and portal pressure. Nonetheless, patients with~     cirrhosis and obesity show a progressive increase in portal pressure, which might explain~     their increased risk of complications. Since obesity is a potentially modifiable risk factor,~     we designed this proof-of-concept study to assess the effects of weight loss (obtained by 4~     months of diet and exercise) on portal pressure in patients with compensated cirrhosis and~     overweight/obesity.~   "
164745|NCT01409343|"~     This is a prospective, open label, multicenter study evaluating the safety, tolerability and~     pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive~     cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour~     response will also be evaluated.~   "
164746|NCT01409330|"~     Diet intervention according to the German Diabetes Risk Score in newly diagnosed type 2~     diabetes.~      This study aims to explore the effect of diet lacking red meat, but containing increased~     fibers and coffee (verum) versus standard recommendation (control) in a multicenter setting.~   "
164747|NCT01409317|"~     Standard high frequency repetitive transcranial magnetic stimulation (HF-TMS) is a~     noninvasive method to activate or de-activate neurons in superficial regions of the brain~     through the induction of weak electric currents in the brain tissue produced by rapidly~     changing magnetic fields. Studies have generally shown standard HF-TMS to be effective in~     treating major depressive disorder (MDD), although treatment effects are often highly~     variable and there are several negative trials in the specialized literature. One reason for~     these discrepant results might be that standard HF-TMS only enables direct stimulation of~     superficial brain areas and, consequently, it is possible that the stimulation of deeper and~     more widespread brain regions could produce superior and more reliable results. Recently, a~     novel form of HF-rTMS (called deep transcranial magnetic stimulation or DTMS), that allows~     direct stimulation of much larger and deeper brain regions, has also been shown to be~     effective and safe in treating MDD. Neuroimaging studies have shown that standard HF-rTMS~     directly affects several superficial areas of the brain, but to date there is no data on the~     brain effects of DTMS. Thus, this study aims to explore, for the first time, the brain~     effects of DTMS in MDD. More specifically, we, the investigators, hope to identify possible~     neural predictors of clinical improvement after DTMS and also clarify the impact of DTMS in~     the brain activity over time. In this study, DTMS will be applied over the left side of the~     front of the head (a region known as the 'prefrontal cortex'), and will be compared with~     standard HF-TMS in terms of its effectiveness and brain effects. For this, subjects with at~     least moderate MDD will be randomized to receive daily DTMS or standard HF-rTMS treatment for~     4 weeks, and will undergo functional magnetic resonance imaging (fMRI) before and after~     treatment. fMRI is a neuroimaging technique that allows us to measure which areas of the~     brain are more or less 'active' in response to specific stimuli at a particular time. During~     the fMRI sessions, we will use a validated cognitive task on working memory. Our results~     could eventually lead us, among other things, to identify which depressed patients would be~     best candidates for receiving either standard HF-rTMS or DTMS, and which areas of the brain~     should be targeted by these neuromodulation techniques.~   "
164751|NCT01409265|"~     The perceptual change on stroke patients during the movement recovery and its relationship~     with social participation still remain unclear. The purposes of this study are: 1) to observe~     the progression of perception deficit and 2) to understand the relationships among perception~     deficit and other functional indicators.~      A total of 90 stroke patients will be recruited. Each patient will receive three times~     evaluation, including perception tests, motor function test, daily living ability tests and~     social leisure participation questionnaires.~   "
164752|NCT01409252|"~     The investigators retrospectively reviewed all patients with neurosurgical operations for~     hemorrhagic stroke (intracerebral hemorrhage) between 1999 and 2008. Research assistant then~     telephoned the survivors for neurological and cognitive status.~   "
164753|NCT01409239|"~     Glycemic variability has been associated with mortality in hospitalized patients with~     hyperglycemia. However, it is unknown how modulation of glycemic variability would impact~     outcomes. One possibility is that glycemic variability could impact autonomic tone. In~     particular, heart rate variability (HRV) measurement is a sensitive marker for measuring~     autonomic tone, and aberrations in HRV have been associated with mortality. The current~     randomized pilot study will compare the effects of continuous intravenous (IV) insulin and~     subcutaneous basal bolus insulin on glycemic variability and autonomic tone in hospitalized~     non-critically ill patients with diabetes. Non-critically ill patients who are hyperglycemic~     or are requiring at least 20 units of insulin per day will be included. Patients with~     conditions that preclude accurate HRV readings (such as atrial fibrillation or paced rhythms)~     will be excluded. Patients randomized to intravenous insulin will receive the therapy for 24~     hours according to our standard hospital guideline. Patients randomized to subcutaneous (SQ)~     insulin will receive basal bolus therapy using insulin analogues. All therapies will begin~     between 8 and 10 AM. Patients will undergo repeated heart rate variability recordings during~     the 24 hour period. Blood draws will be collected at baseline and at 24 hours for measurement~     of catecholamines, insulin, and c-peptide. Glycemic variability will be measured using a~     continuous subcutaneous glucose monitor and reported as coefficient of variation. The primary~     outcome measure is low frequency-to-high frequency power spectrum ratio of heart rate~     variability.~        1. Glycemic variability is associated with unfavorable changes in autonomic tone, as~          assessed by low frequency (LF)/high frequency (HF) HRV ratio, independent of changes in~          overall glycemia.~        2. Short-term increases in glycemic variability, followed by more prolonged glycemic~          stability are observed in generalized hospitalized patients treated with intravenous~          insulin compared to standardized basal bolus therapy. LF/HF HRV differs among subjects~          receiving intravenous compared to subcutaneous insulin.~        3. Glycemic variability differs among subjects receiving intravenous compared to~          subcutaneous insulin~   "
164754|NCT01409226|"~     This study is to find out if 3.0 Tesla (3.0-T) Magnetic Resonance Imaging (MRI) will improve~     in diagnosing breast cancer in women with high-risk of breast cancer.~   "
164755|NCT01409213|"~     The purpose of this study is to collect information of the risk profile of patients with type~     2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of~     diabetic patients type 2 published by the Deutsche Diabetes Gesellschaft (DDG) on October 13,~     2008~   "
164756|NCT01409200|"~     The goal of this clinical research study is learn if adding axitinib to hormonal therapy can~     help to control prostate cancer when given before surgery. The safety of this drug will also~     be studied.~      This is an investigational study. Axitinib is FDA approved for kidney cancer. Axitinib is~     currently being used for research purposes only in prostate cancer.~      Up to 72 patients will be enrolled in this study. All will be enrolled at MD Anderson.~   "
164757|NCT01409187|"~     The goal of the Phase I part of this clinical research study is to find the highest tolerable~     dose of the drug Yervoy (ipilimumab) that can be given with the drugs Intron-A (interferon~     alfa-2b) and Proleukin (aldesleukin, IL-2) to patients with metastatic melanoma. The safety~     of this combination will also be studied in Phase I. The goal of Phase II is to learn if this~     combination can help to control metastatic melanoma.~      Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells~     that decrease the immune system's ability to fight cancer.~   "
164758|NCT01409174|"~     The goal of the Phase I part of this clinical research study is to find the highest tolerable~     dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar (temozolomide),~     Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) to~     patients with metastatic melanoma. The safety of this combination will also be studied in~     Phase I. The goal of Phase II is to learn if this combination can help to control metastatic~     melanoma. Note: The study was closed following Phase I enrollment.~      Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells~     that decrease the immune system's ability to fight cancer.~      Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of~     cells). This may stop the cancer cells from dividing into new cells.~      Cisplatin is designed to poison the cancer cells, which may cause them to die.~   "
164759|NCT01409161|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if the combination of all-trans retinoic~     acid (ATRA), arsenic trioxide (ATO), and gemtuzumab ozogamicin (GO) can help to control acute~     promyelocytic leukemia (APL). The safety of this drug combination will also be studied.~      This is an investigational study. ATRA and ATO are FDA approved and commercially available.~     GO is not FDA approved or commercially available. At this time, it is being used for research~     purposes only.~      Up to 150 patients will take part in the study. All will be enrolled at MD Anderson.~   "
164760|NCT01409148|"~     The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive~     monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT~     imaging in patients with AL amyloidosis.~   "
164761|NCT01409135|"~     A study examining the safety of AGS-22M6E or ASG-22CE administered as monotherapy therapy in~     subjects with malignant solid tumors that express Nectin-4.~   "
164762|NCT01409122|"~     This is a four-part study of the safety, tolerability, and PK profile of sodium nitrite~     inhalation solution (AIR001) of ascending multiple doses (Part A) and of escalating doses~     with steady-state sildenafil (Part B) to healthy male and female subjects, as well as~     assessment of the safety and tolerability of multiple doses of AIR001 to patients with~     pulmonary arterial hypertension (part C) with a single dose PK study of AIR001 utilizing~     three different nebulizers (Part D).~   "
164773|NCT01408979|"~     Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal~     duration of this treatment after delivery is still to be established. The hypothesis is that~     in stable patients a shorter course of treatment is possible without prejudice to the mother.~   "
164774|NCT01408966|"~     This study was aimed at testing the hypothesis that supplementing a meal with dark chocolate,~     which holds potent antioxidant properties, might attenuate the postprandial increase in the~     hepatic venous pressure gradient (HVPG, clinical equivalent of portal pressure) in patients~     with cirrhosis~   "
166019|NCT01392690|"~     The purpose of this study is to assess the impact of a primary prevention program for anxiety~     disorders.~      This study was completed between 2000 and 2002, with the final report transmitted to the~     Quebec ministry of health in 2003.~   "
164763|NCT01409109|"~     Several observations have been made with magnetic resonance imaging (MRI) that characterize~     brain connections and brain function in individuals with schizophrenia and other mental~     disorders. For example, research investigating schizophrenia focuses on the dysfunction of~     connections within and between the medial temporal lobe and the prefrontal cortex as well as~     other pertinent brain regions. This database registry will allow for the collection of~     clinical interview data, behavioral data, blood, magnetic resonance imaging (MRI) data, and~     functional magnetic resonance imaging (fMRI) data on individuals with and without mental~     disorders to better understand how connections in the brain and various brain regions~     function differently while volunteers perform various cognitive tasks. This is an~     observational study that is being conducted to collect data and place it in a registry for~     current and future investigational questions related to imaging in mental disorders.~   "
164764|NCT01409096|"~     Primary purpose of this study is to determine if pregnenolone supplementation is associated~     with greater improvement in depressive symptoms of patients with bipolar disorder. Also the~     study will explore possibilities of improving anxiety and manic symptoms as well as the~     patient's cognition.~   "
164765|NCT01409083|"~     Sodium bicarbonate injected into a blood vessel transforms to carbon dioxide and water. The~     increase in carbon dioxide production can be detected by measuring the exhaled carbon dioxide~     in the lungs.~      This study is conducted to access the clinical application of measuring exhaled carbon~     dioxide to verify the correct position of intravenous catheters.Once the catheter is in the~     correct position the injected bicarbonate will be detected as a distinct elevation of exhaled~     carbon dioxide. A similar study was already performed in adults and was found useful. The~     investigators now extend the clinical application to children.~   "
164766|NCT01409070|"~     In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have~     been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been~     evaluated the head to head comparison of two drugs. This study is a retrospective study to~     compare the efficacy of two drugs.~   "
164767|NCT01409057|"~     Since selenium has demonstrated significant characteristics for a series of biochemical~     processes, for antioxidant activity and immune stimulation, this observational study should~     represent the effect of heart-lung-machine on selenium status of cardiac surgical patients~     undergoing coronary bypass surgery. It will be examined in (approximately 100) adult~     patients, under which 50 patients are operated conventionally (meaning with the use of~     heart-lung-machine). Another 50 patients are operated on beating heart without the use of~     heart-lung-machine (OPCAB = off pump coronary artery bypass). The allocation of individual~     patients in these two groups is done according to clinical criteria and is undertaken by the~     operating surgeon.~   "
164768|NCT01409044|"~     Background:~      - Studies have shown that listening to music can decrease pain and anxiety. Following~     surgery, patients in intensive care units (ICUs) often need drugs to treat their pain and~     anxiety. But these drugs can cause side effects such as low blood pressure and confusion. If~     listening to music can help lower pain and anxiety levels, less medication might be needed~     and these side effects could be avoided.~      Objectives:~      - To determine the effects of music on patient pain and anxiety in the first few days after~     surgery.~      Eligibility:~      - Individuals at least 18 years of age who are scheduled to have surgery that requires a~     24-48-hour stay in intensive care afterward.~      Design:~        -  All participants will be screened with a medical history before having surgery.~        -  Participants will be divided into two groups: one group will listen to music after~          surgery, and the other will not.~        -  Before surgery, participants will answer questions about their pain and anxiety levels.~          They will also be shown how to control the device that lets them administer their own~          pain medication after surgery.~        -  Following surgery, all participants will be transferred to the ICU and will answer the~          same questions about pain and anxiety levels.~        -  The music group will listen to a specially created CD of instrumental music for about 50~          minutes, four times a day. The standard group will not listen to this music. All other~          treatments will be the same in both groups. Both groups will continue to answer the same~          questions about pain and anxiety levels.~        -  Participants will have a final 15- to 20-minute interview after leaving the ICU. They~          will answer questions about the ICU stay and (for those in the music listening group)~          the music.~   "
164769|NCT01409031|"~     The purpose of this study is to determine whether intravenous sildenafil reduces pulmonary~     artery pressure and improves oxygenation in near-term and term infants with persistent~     pulmonary hypertension.~   "
164770|NCT01409018|"~     This study investigated repeated-dose pharmacokinetics and safety of itraconazole and its~     active metabolite hydroxyitraconazole in pediatric cancer patients at risk for the~     development of invasive fungal disease.~   "
164771|NCT01409005|"~     Although there have been remarkable advances in the treatment of metastatic or recurrent~     colorectal cancer (MRCRC), long term survival cannot be expected in most patients with MRCRC~     because of inevitably developing resistance to chemotherapeutic drugs except some MRCRC~     patients who can undergo complete resection (metastasectomy). Until now, approved cytotoxic~     drugs for treatment of MCRC are only 3 categories (fluoropyrimidine, oxaliplatin and~     irinotecan). Recently, molecularly targeted drugs are approved for MRCRC patients, and~     bevacizumab and cetuximab (for K-ras wild type tumors) are available. When cytotoxic and~     targeted drugs are appropriately combined, about 24 months of overall survival (OS) can be~     expected in patients with MRCRC. However, when these drugs are all used or patients cannot~     afford to receive expensive targeted drugs because of economical problems, there is no option~     for chemotherapy and best supportive care is the only option, although some patients still~     have good performance status and medical conditions. Therefore, there are unmet needs for~     additional salvage chemotherapy regimens for patients with oxaliplatin, irinotecan and~     fluoropyrimidine-refractory MRCRC.~      In some previous studies, gemcitabine-based chemotherapy showed some antitumor activities in~     MRCRC patients. Especially, when combined with fluoropyrimidine, gemcitabine has been shown~     to exert synergic effects on antitumor activities. On these backgrounds, this phase 2~     clinical study was designed. In this study, efficacy and safety of gemcitabine plus UFTE~     chemotherapy will be evaluated in MRCRC patients.~   "
164772|NCT01408992|"~     This study is aimed to test the sensitivity and specificity of Thai-version Five Minutes~     Hearing test against the audiometry to screen hearing problem in community.~   "
164775|NCT01408953|"~     Keloid is chronic skin conditions that results in formation of tumor like growths on the~     skin. Despite its benign nature, keloid can cause severe aesthetic and, in some cases,~     functional problem which negatively impacts person's quality of life.~      Keloids do not regress on their own and results of most available treatments such as surgery,~     injecting keloids with steroids, chemotherapy injections, or even radiation therapy, have~     mostly proven disappointing.~      Some laboratory studies have shown that there is excessive amount of a protein called~     vascular endothelial growth factor (VEGF) in keloid tissue. This may play role in the~     formation and evolution of keloid.~      Bevacizumab is a drug that works by targeting vascular endothelial growth factor (VEGF) which~     helps new blood vessels form. Without new blood vessels, the growth of the keloid may be~     slowed~      Based on presence of excess amount of VEGF in keloid tissue, we hypothesize that bevacizumab~     will be effective in treatment of keloids. This exploratory clinical trial is to confirm or~     reject this hypothesis.~   "
164776|NCT01408927|"~     The primary objective of this prospective clinical registry is to determine the prevalence~     and level of thienopyridine resistance seen in a population undergoing contemporary~     percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).~   "
164777|NCT01408914|"~     The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to~     shorten treatment for tuberculosis (TB) without causing more adverse events. The hypotheses~     are that higher doses of RIF will result in higher blood concentrations of RIF; higher blood~     concentrations will result in tuberculosis bugs being killed more quickly; and, both of these~     will happen without more adverse events. Patients with active, infectious, drug-susceptible~     TB who agree to participate will be randomly assigned to 1 of 3 doses of RIF. All patients~     will also receive standard doses of regular (3) companion drugs for 2 months of daily,~     supervised therapy. The study will assess the following among the 3 study arms (oral doses of~     RIF 10, 15 & 20 mg/kg/day) during the initial 8 weeks of treatment: 1) the amount of RIF in~     the blood after at least 14 days of treatment; 2) the difference in the number of~     tuberculosis bugs killed; 3) the frequency of adverse events.~   "
164778|NCT01408901|"~     The PROPEL study will test the hypothesis that GM-CSF combined with supervised treadmill~     exercise will significantly improve functional performance in patients with PAD more than~     GM-CSF alone or supervised treadmill exercise alone. In addition to identifying novel~     therapeutic options for patients with PAD, the current proposal is expected to identify~     mechanisms by which functional impairment is improved in patients with PAD.~   "
164779|NCT01408888|"~     The purpose of this study is to study the effect of LY2189265 on how the body absorbs and~     processes a Type 2 Diabetes Mellitus (T2DM) drug (sitagliptin) and how sitagliptin affects~     LY2189265 when they are taken together.~      The duration of participation in this study is expected to be approximately 61 days. The~     study requires 2 clinic confinements (one of 2 nights and one of 19 nights duration).~      The study involves 3 injections, subcutaneous, of 1.5 milligrams (mg) LY2189265 and 18 daily~     doses of 100 mg sitagliptin tablets administered orally.~   "
164780|NCT01408875|"~     The purpose of this study is to determine if addition of low frequency~     electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity~     and/or muscular strength in chronic heart failure patients.~   "
164781|NCT01408862|"~     Novel drugs for the treatment of patients with diabetes are of interest for cardiologists if~     they reduce the risk of cardiovascular events. However, as documented by the current~     discussion about the potential benefits of glitazones, high hopes can fail. Initial~     beneficial cardiovascular effects shown in proof-of-concept studies were muted by the~     apparent higher mortality in the metaanalysis of studies with rosiglitazone. The rapidly~     increasing use of GLP-1 analogues and DPP-4 (Dipeptidyl protease 4) inhibitors for the~     treatment of type 2 diabetes mellitus may be of major interest for the cardiologist.~     Potential beneficial actions on the cardiovascular system so far shown in animal experiments~     and small proof of concept studies may provide the rationale for using these drugs~     specifically in diabetic patients with secondary complications such as macrovascular disease~     or diabetic cardiomyopathy. Theoretically, these new therapies could also proof beneficial in~     patients with heart failure, independently of concomitant diabetes mellitus. However, many~     unanswered questions need to be addressed in the near future to extend the experimental~     findings to potential benefits of real life patients. In summary a new class of antidiabetic~     drugs, which could possibly directly influence cardiovascular effects of diabetes mellitus~     and thus possibly treat or even prevent life threatening complications has become available.~      Then our working hypothesis was that incretins may have desirable cardiovascular outcomes~     through modulating platelet function. In order to test this hypothesis we propose to assess~     the presence of their specific receptors in isolated human platelets. In addition, we~     proposed to sudy the effect of the endogenous incretins (glucagon-like peptide 1 and gastric~     inhibitory peptide) on human platelet function isolated in a test tube.~   "
164782|NCT01408849|"~     This study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia~     Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is SODA~     score, secondary endpoint is endoscopic classification (Sydney).~   "
164783|NCT01408836|"~     The purpose of this study is to test whether additional therapy with plasma exchange improves~     the chances of kidney recovery in severe kidney vasculitis.~   "
164784|NCT01408823|"~     This study will evaluate the pharmacokinetics of antifibrinolytic drug epsilon-aminocaproic~     acid (EACA) in children undergoing Posterior spinal fusion surgery (PSF) at The Children's~     Hospital of Philadelphia (CHOP) who receive EACA at the standard dose reported in the~     literature for this population and currently in use at CHOP.~   "
164785|NCT01408810|"~     The aim of this study is to assess the relationship between microscopic Geboes index of~     inflammation and clinical course of ulcerative colitis in patients treated with infliximab.~     The investigators propose to test the hypothesis if infliximab is able to induce histological~     remission and then change the clinical course of ulcerative colitis.~   "
164786|NCT01408797|"~     The objective of this trial is to determine if clonal deletion before kidney transplantation~     can effectively reduce the need for post transplant immunosuppression. The investigators will~     adapt a DAWN (Drugs (immunosuppressants) Added When Needed) treatment protocol to assess the~     effect of clonal deletion and closely monitor acute rejection, renal function, and graft~     survival. 15 patients eligible for the study as described below will be enrolled.~   "
164787|NCT01408784|"~     The purpose of this study is to assess the validity of self-caloric evaluation, the~     categories method - a new method based on one categorical score per meal~   "
164788|NCT01408771|"~     The purpose of this study is to find out whether swallowing has an effect on the degree of~     urinary urgency and on the amplitude of detrusor contraction during filling cystometry in~     patients with detrusor overactivity (DO).~   "
164789|NCT01408758|"~     The Virtual Clinician Research Tool (VCRT) will use a virtual format to present our National~     Cholesterol Education Program (Brown, 2004) and the Tobacco Use and Dependence Treatment~     Clinical Guideline (Fiore et al., 2008) integrated with principles of human motivation from~     Self-Determination Theory (SDT) for patients with elevated risk for cardiovascular disease~     from LDL-cholesterol or tobacco dependence.~   "
164790|NCT01408745|"~     The primary objective is to establish if the SternumFix System improves sternal closure. The~     study should test the hypothesis that in a high risk patient population with increased risk~     for the development of sternal wound complications SternumFix will reduce the incidence of~     sternal healing complications. The control group will be treated with wire cerclage, the~     standard method of sternal closure.~   "
164791|NCT01408732|"~     The purpose of this study is to test a novel and tolerable office-based treatment method,~     sclerotherapy with sodium tetradecyl sulfate, for recurrent epistaxis (nosebleeds) related to~     Hereditary Hemorrhagic Telangiectasia (HHT) disease.~   "
164792|NCT01408719|"~     The primary aim of this study is to determine whether the cholesterol-lowering efficacy of~     barley b- glucan varied as function of molecular weight (MW) and the total daily amount~     consumed. Our second aim is to investigate the mechanism responsible for the action,~     specifically, whether β-glucan lowers circulating cholesterol concentration via inhibiting~     cholesterol absorption and synthesis. Thirdly, we aim to determine if any gene-diet~     interactions are associated with cholesterol lowering by barley β-glucan. In addition, we aim~     to investigate the alteration of the gut microbiota after β-glucan consumption and the~     correlation between the altered gut microbiota and cardiovascular disease risk factors.~   "
164793|NCT01408706|"~     The purpose of this study is to compare reproducibility of the device position and location~     of the prostate rectum interface between two immobilization devices for radiation therapy of~     prostate carcinoma.~   "
164794|NCT01408693|"~     The aim of the study is to test the hypothesis that patients older than 60 years with a~     femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior~     minimal-invasive approach as compared to a standard lateral Hardinge approach show better~     functional recovery postoperatively as measured by the Timed up and go-test (TUG).~   "
164795|NCT01408680|"~     The investigators believe that relieving the oxidative stress experienced by hemodialysis~     patients may help improve cardiovascular health.~      In this study, the investigators hypothesize that administration of coenzyme Q10, as a~     targeted antioxidant therapy, will ameliorate the excessive oxidative stress experienced by~     hemodialysis patients. This will lead to improvements in biomarkers of:~        -  oxidative stress status~        -  inflammatory status~        -  endothelial dysfunction~   "
164796|NCT01408667|"~     The purpose of the study is to determine the safety and efficacy of TRC150094 in male~     patients with cardiometabolic risk. Cardiometabolic risk which is the overall risk of~     cardiovascular disease (CVD) and diabetes resulting from the presence of hypertension, HDL~     cholesterol, insulin resistance, dysglycemia and visceral obesity.~   "
164797|NCT01408654|"~     This randomized trial compares peer companionship to care-as-usual in primary care on the~     outcome of risk for suicidal behavior in late life. The investigators hypothesize that older~     adults assigned to receive peer companionship will report greater social connectedness and~     less death and suicidal ideation compared to older adults assigned to care as usual.~   "
164798|NCT01408641|"~     Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder~     (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more~     difficult than treating AUDs in the general population. The FDA-approved medication~     topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has~     also improved symptoms in people with PTSD. This study is designed to investigate whether~     topiramate will improve drinking outcomes in Veterans with PTSD.~   "
164799|NCT01408628|"~     The primary purpose of the study is demonstration that teaching insulin management in small~     groups of type 2 diabetes patients in 4 weekly live Internet sessions is safe and provides~     an important resource for rural diabetes care providers who may otherwise, because of lack of~     time or staff, not be able to put patients on insulin who need it.~   "
164800|NCT01408615|"~     This observational study will examine the safety and efficacy profile of Elonva~     (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian~     stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist for~     the development of multiple follicles in an assisted reproductive technology (ART) program.~   "
164801|NCT01408602|"~     This study will treat moderate to severe rheumatoid arthritis with MRC375 (either 75 mg 3~     times a day, 150 mg 3 times a day or placebo 3 times a day)in patients 18 years of age or~     older that can be currently on low doses of methotrexate or can stop treatment of current RA~     medications to enter the study. Safety of MRC375 will also be evaluated. There are up to 8~     clinic visits over 24 weeks.~   "
164802|NCT01408589|"~     This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40,~     60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) on alcohol-elicited~     craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the~     fact that it targets NET, neither of which has heretofore been examined in the context of~     alcohol dependence. It is hopeful that this pilot study, of 86 total individuals, will~     provide the PI with sufficient preliminary data to submit a subsequent R01 application to~     study atomoxetine and the involvement of specific single nucleotide polymorphisms within the~     NET gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations.~     The long-term objective of this research is to develop more efficacious treatment~     interventions for alcohol abuse and dependence.~      Hypothesis 1: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine~     for 5 days will demonstrate significantly less alcohol-elicited craving than subjects who~     receive a placebo.~      Hypothesis 2: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine~     for 5 days will be less sensitive to the acute effects of alcohol (subjective intoxication)~     than subjects who receive a placebo.~   "
164803|NCT01408576|"~     The primary objective of the study is assess the safety and tolerability of long-term~     epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)~   "
166020|NCT01392677|"~     This study intends to compare the efficacy and safety of dapagliflozin versus placebo in~     patients with type 2 diabetes who have inadequate glycaemic control on a background~     combination of metformin and sulfonylurea.~   "
164804|NCT01408563|"~     This trial will use two cord blood units for transplantation using a reduced intensity~     regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood~     units (double cord blood) are being used, as the numbers of blood cells in one unit are too~     few to allow successful growth of these cells.~      Because the risk of infection, particularly virus infection, is high after double cord blood~     transplant, this study seeks to reduce the rise of virus infection by using a reduced~     intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior~     cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and~     fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The~     number of patients with virus infections in this study will be compared to our prior~     experience using the ATG.~   "
164805|NCT01408550|"~     Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national~     diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the~     exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five~     consecutive days or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for~     therapy of bullous pemphigoid will be evaluated the score using pemphigus disease area index~     (PDAI) and pemphigoid activity score involving skin lesion area and Number of new blisters.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by 57 days after the start of the study treatment.~   "
164806|NCT01408537|"~     Japanese encephalitis (JE) is the main cause of viral encephalitis in many countries of Asia~     including Thailand. Estimated annual mortality ranges from10,000-15,000 deaths, while the~     total number of clinical cases is about 50,000. Of these cases, about 50% result in permanent~     neuropsychiatric sequelae. The disease occurs mostly among children aged <10 years. There is~     no specific antiviral treatment for JE. Vaccination is the single most important control~     measure. This study aims to evaluate the immunogenicity and safety of inactivated Vero cell~     derived JE vaccine (Beijing P-3 strain) produced by Liaoning Cheng Da Biotechnology Co., Ltd,~     China JEVAC in Thai children.~      152 healthy Thai children aged between 1-3 years will be vaccinated with JEVAC in a dose of~     0.5 mL. subcutaneously on Day 0, 1-4 weeks later and a booster vaccination at one year~     (totally 3 doses). Two mL. of blood will be drawn on Day 0, 4 weeks after second dose, at one~     year on booster vaccination day and 4 weeks after the booster (totally 8 mL. of 13 months~     study period) for determination of JE neutralizing antibodies (PRNT50) using Beijing P3~     strain. Adverse events will be observed for 28 days after each vaccination. Serious adverse~     events will be observed throughout the study period.~   "
164807|NCT01408524|"~     The purpose of this study is to determine the effectiveness of the antihypertensive drugs in~     the control of emergence blood pressure after tumor resection craniotomy; compared between~     labetalol (Avexa) and diltiazem (Herbessor).~      Also the investigators seek to determine the effective dose of the antihypertensive drugs and~     their side effects in Thai population.~   "
164808|NCT01408511|"~     A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat~     0.1% ointment in adults with atopic dermatitis.~   "
164809|NCT01408498|"~     The study aims to establish a clear causal link between testosterone and threat perception~     and behavioral responses to threat. Namely, the study focuses whether high levels of~     testosterone will cause an individual to exhibit increased physiological responses to threat~     (e.g., increased blood pressure, heart rate, and endocrine responses) and a decreased~     behavioral response (e.g., ignoring the threat, avoiding the threat, and postponing dealing~     with the threat). The threat in this study is a social threat involving public speaking, and~     is an outgrowth of previous research on the avoidance of health threats.~   "
164810|NCT01408485|"~     To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is~     effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its~     use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse~     events.~   "
164811|NCT01408472|"~     Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple pre-clinical models to~     enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in~     diseases like glaucoma. We hypothesize that CNTF delivery to the human eye will provide~     neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in~     glaucoma. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into~     one eye, and will be carefully followed to evaluate safety and efficacy.~   "
164812|NCT01408459|"~     The purposes of this study are to explore the dynamics of adherence, using a simple whole~     food intervention strategy, both prior to and during the intervention period and to identify~     nutrient shifts in self-selected diets and to determine health risks (blood pressure,~     hyperlipidemia, and body weight) that may have resulted from increased tomato product~     consumption.~   "
164813|NCT01408446|"~     Prehypertension and mild hypertension are associated with an increased risk of~     atherosclerosis and coronary artery disease, and often complicated with the metabolic~     disorder of glucose and lipid. The comprehensive prevention of hypertension is still an~     important and complex clinical issue. Peppermint is a popular flavoring agent, and peppermint~     tea help relax tension and could lower blood pressure. The effect of oral peppermint on blood~     pressure is not consistent, however, our previous animal study has shown that oral~     administration of menthol, the main component of peppermint, could reduce 24-hour mean~     arterial systolic and diastolic blood pressure in spontaneous hypertensive rats. Furthermore,~     menthol increases uncoupling protein(UCP)1 dependent thermogenesis and energy expenditure~     through transient receptor potential melastatin(TRPM)8 activation, and helps prevent obesity~     and metabolic disorders. In a prospective, double-blind, randomized, and parallel-group~     study, we will evaluate the effects of DANSHU capsule(menthol) on blood pressure and~     metabolic parameters in prehypertensive and mild hypertensive patients. This study will help~     develop future comprehensive prevention and treatment strategies for hypertension.~   "
164814|NCT01408433|"~     This study seeks to compare the pregnancy and delivery rates of patients who undergo a single~     embryo transfer, when the embryo has been tested and determined to be chromosomally normal,~     with pregnancy and delivery rates of patients who undergo a two (2) embryo transfer of~     untested embryos.~   "
165206|NCT01403298|"~     The purpose of this project is to compare the effect of a family-based HIV prevention program~     to the effect of an adolescent-only health promotion program on adolescent HIV risk and~     marijuana use among adolescents enrolled in the Juvenile Drug Court (JDC) of the Rhode Island~     Family Court.~   "
164815|NCT01408420|"~     In Denmark around 3500 procedures are conducted involving a heart-lung-machine per year. An~     increase in the prevalence of postoperative kidney insufficiency have been observed following~     these procedures, during the last years. Kidney related complications are associated with a~     higher mortality and morbidity.~      The reason and mechanisms behind this impaired kidney function is unknown. One possible cause~     could be that the blood pressure used in the heart-lung-machine is too low, during surgery.~     In the PPC trial we plan to include 100 patients. One half of the patients are operated with~     a normal, lower, blood pressure on the heart-lung-machine. The other half receives a blood~     pressure of > 60 mmHg during surgery.~      The primary goal of the trial is to measure the kidney function (GFR) the day before surgery~     compared to day 4 - 6 and 4 months (+/- 14 days) after surgery. During the surgery a catheter~     is inserted through the femoral vein into the kidney vein. This makes it possible to measure~     several biochemical markers and the oxygen consumption of the kidney, during the surgery.~     Urine samples are also collected and analyzed.~      The study hypothesis:~      The glomerular filtration rate (GFR) is better preserved after cardiac surgery with extra~     corporal circulation with an intended increased periprocedural arterial blood pressure~     compared to current practice.~   "
164816|NCT01408407|"~     The purpose of this study is to determine whether Alkagin paste is effective at preventing~     radiodermatitis in patients receiving external beam radiation therapy to the perineal area.~   "
164817|NCT01408394|"~     Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible~     diseases. To date, all clinical studies have been done using the ecopipam immediate release~     (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been~     produced that may be able to improve its effectiveness and reduce its side effects. The main~     purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when~     given as single oral dose in healthy volunteers.~   "
164818|NCT01408381|"~     Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group~     controlled with three levels of dose.~      The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide~     progenitor cells with regenerative capacity and besides secrete several angiogenic factors,~     and their implantation into ischemic tissues with both elements should contribute to~     angiogenesis and tissue regeneration with recovery of the circulation in the affected limb.~   "
164819|NCT01408368|"~     The extent of thyroid resection in Graves' disease remains controversial. The aim of this~     study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total~     thyroidectomy in patients with Graves' ophthalmopathy.~   "
164820|NCT01408355|"~     To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose~     via both intravenous and oral routes.~   "
164821|NCT01408342|"~     The purpose of the study is to evaluate the efficacy of combination of alemtuzumab and~     rituximab as first line therapy in aplastic anemia.~   "
164822|NCT01408329|"~     Cyclic Variation in Altitude Conditioning (CVAC) is a new technique that uses a pod-like~     device to expose users to controlled fluctuations in air pressure. It is designed to promote~     quicker altitude acclimatization, thus promoting improvements in exercise capacity at~     altitude and, possibly, at sea level. However, over the past few years, anecdotal stories~     from users of the device suggest that the CVAC treatments might be causing changes beyond the~     expected endurance exercise performance benefits. Therefore, the purpose of the study is to~     obtain data on some of the previous anecdotal claims regarding the device (e.g. increases in~     strength, improved glucose tolerance, reduction of neuropathic pain and decreased joint~     swelling) as well as to obtain broad questionnaire data in order to identify more specific~     variables to investigate in future studies.~   "
164823|NCT01408316|"~     This is a two part study designed to evaluate the PK profile of PX-866 capsules versus~     tablets, and to evaluate the effect of food on the PK of PX-866 tablets only in healthy~     volunteers.~   "
164824|NCT01408303|"~     The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an~     optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in~     subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.~   "
164825|NCT01408290|"~     The purpose of this study is to determine the immunogenicity, tolerability and dose-effect~     relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent~     influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1,~     A/H3N2 and B influenza antigens in adults and elderly people.~   "
164826|NCT01408277|"~     Subjects enrolled in this study will either use Santyl daily or follow standard care~     procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the~     subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will~     look at the wound in the office each week (up to 12 weeks) to see if the wound is healing.~     Depending on a number of factors at each office visit, the study doctors may also use a~     procedure called sharp debridement to remove dead skin from the wound.~      This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl~     will result in more rapid healing, healthier wounds, and fewer required sharp debridements~     over the study period than for diabetic foot wounds treated in other ways.~   "
164827|NCT01408264|"~     The aim of this study is to determine whether using a smaller wire results in a higher~     success rate at endoscopic retrograde cholangiopancreatography (ERCP), and lower incidence of~     adverse events~   "
164828|NCT01408251|"~     The purpose of this study is to see if blood obtained from a vein (smaller blood vessel) can~     be used instead of blood obtained from an artery (larger blood vessel).~   "
164829|NCT01408238|"~     The objective of this study is to determine the biologic activity of a Secale cereale~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
164865|NCT01407757|"~     RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well~     patients will respond to treatment. It may also help doctors learn more about how gemtuzumab~     ozogamicin works in the body.~      PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients~     with acute myeloid leukemia treated on COG-AAML0531.~   "
165250|NCT01402726|"~     The purpose of this study is to observe the incident of composite cardiovascular events after~     renal sympathetic modification using THERMOCOOL® catheter in patients with heart failure, and~     evaluate safety and efficacy of the intervention.~   "
164830|NCT01408225|"~     The investigators are researching patients with diseases of their plasma cells in order to~     improve their quality and length of life. The investigators have created a database of~     patient information, blood samples, and bone marrow tissue in order to achieve the following~     three goals:~        -  Surveillance: The investigators want to track what treatments patients get or don't get,~          how effective they are, how they feel, what complications they suffer, how long they~          stay in remission, and how long they live.~        -  Contact: Because myeloma and amyloidosis are rare, less than 700 patients are diagnosed~          in the state of Ohio each year, patients often feel they don't have accurate~          information. The investigators want to provide them access to our clinical team (both~          phone and email consultations, even office visits for patients that can come to~          Columbus) as well as information regarding informational events pertaining to your~          disease and local support groups.~        -  Research: Because nearly all myeloma and amyloid patients relapse and treatment is~          eventually unsuccessful, our focus is to develop more effective treatments that not only~          prolong life, but cure the disease. Periodically the investigators will inform them~          about clinical trials studying new drugs or treatment paradigms.~   "
164831|NCT01408212|"~     This study aims for evaluating the effectiveness, safety and feasibility of additional~     acupuncture therapy for lung cancer patients who are under chemotherapy in an inpatient~     setting. The acupuncture therapy will be administered during a resting period between cycles~     of chemotherapy.~   "
164832|NCT01408199|"~     Cutaneous Lupus is frequent. Approximately 70% of patients with SLE will develop cutaneous~     involvement at some point during course of their disease. In spite of the esthetic~     consequence during the acute phase, the main problem is still related to its disfiguring and~     incapacitating nature. Topical steroids and/or antimalarial therapy continue to be the~     conventional therapy. Unfortunately, approximately 30% will be refractory to these measures.~     For those patients, immunosuppressive therapy can be an alternative with controversial~     results. Several series have shown a 90% of clinical efficacy in patients treated with~     Thalidomide. Unfortunately, the main drawback has been the serious described side effects~     such as fetal malformations, polyneuropathy and drowsiness. Recently, a new thalidomide~     analogue, more potent, efficient and with better safety profile has been discovered. The main~     objective of the study is to evaluate the efficacy and safety of Lenalidomide for patients~     with Refractory cutaneous Lupus. Secondary objectives include evaluating the effect of this~     drug on the systemic manifestations of lupus disease, the adverse effects, frequency of flare~     after withdrawal, the sequela and the effect on the seric parameters. Methods: Twelve~     patients with refractory cutaneous lupus will be included. Lenalidomide will be started at~     5mg/day and tapered progressively. Blood test and EMG will be performed at onset and at the~     end of follow up.~   "
164833|NCT01408186|"~     Peptic ulcer bleeding associated with ASA or NSAIDs is a major cause of hospitalization in~     Hong Kong. The investigators previously showed that ASA or NSAIDs accounted for about half of~     all cases of hospitalizations for peptic ulcer bleeding. Currently, ASA use has contributed~     to about one-third of the bleeding ulcers admitted to the investigators hospital that serves~     a local population of 1.5 million.~      In patients with acute coronary syndrome or acute ischemic stroke who develop ASA-induced~     bleeding peptic ulcers, whether ASA should be discontinued before ulcers have healed is a~     major dilemma. In another double-blind randomized trial, the investigators have shown that~     discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a~     significantly increased in mortality within 8 weeks.~      In the absence of safer aspirins, co-therapy with a gastroprotective drug remains the~     dominant preventive strategy. Given the vast number of people taking ASA, however, it is only~     cost-effective to identify and treat those who are at high risk of ulcer bleeding and who~     have a strong indication for ASA use. Data from observational studies and randomized trials~     have consistently shown that PPIs are effective in reducing the risk of ulcer bleeding~     associated with ASA. Other potential preventive strategies include eradication of H. pylori~     infection, substitution of ASA for other non-aspirin anti-platelet drugs, and co-therapy with~     misoprostol or H2RAs.~   "
164834|NCT01408173|"~     The aim of the present Phase III study is to evaluate the safety, efficacy and~     pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.~   "
164835|NCT01408160|"~     This phase I trial studies the side effects and the best dose of deglycosylated ricin A~     chain-conjugated anti-cluster of differentiation (CD)19/anti-CD22 immunotoxins when given~     together with cytarabine in treating patients with B-cell acute lymphoblastic leukemia that~     has come back after a period of improvement (relapsed) or does not respond to treatment~     (refractory). Immunotoxins, such as deglycosylated ricin A chain-conjugated~     anti-CD19/anti-CD22 immunotoxins, can find certain cancer cells and kill them without harming~     normal cells. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Giving deglycosylated ricin A chain-conjugated~     anti-CD19/anti-CD22 immunotoxins with cytarabine may kill more cancer cells.~   "
164836|NCT01408147|"~     This study will examine the effects of an online behavioral intervention to promote weight~     loss in low income postpartum women in the WIC program.~   "
164837|NCT01408134|"~     The primary objective of this study is twofold:~        1. To define inter-reader variability of myocardial viability imaging within the first pass~          and delayed enhancement cardiac CT perfusion imaging~        2. To evaluate DE CT image quality using a consensus DECT protocol~   "
164838|NCT01408121|"~     This is a genetic and platelet reactivity study of African-American versus Caucasian patients~     undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel. The~     investigators aim is twofold: to describe differences in allele frequencies between~     African-Americans and Caucasians, and to explore associations of platelet reactivity and~     genetic polymorphisms in these two groups.~   "
164866|NCT01407744|"~     This research trial studies tumor samples from patients with ependymoma treated on the~     Children Oncology Group ACNS0121 trial. Studying samples of tumor tissue from patients with~     cancer in the laboratory may help doctors learn more about changes that occur in DNA and~     identify biomarkers related to cancer. It may also help doctors find better ways to treat~     cancer.~   "
165251|NCT01402713|"~     The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of~     'GC1107' administered intramuscularly in healthy children~   "
164839|NCT01408108|"~     This study is prospective randomized trial enrolling at least 100 participants which compares~     efficacy and safety of two alternative methods of laparoscopic hiatal repair for large (i.e.~     with hiatal surface area (HSA) ranging from 10 to 20 sq.cm, which corresponds to diameter of~     defect from 5 to 8 cm) types I, II, and III hiatal hernias: primary crural repair and repair~     with partially absorbable lightweight mesh. According to the literature, rates of anatomical~     failure and recurrence of GERD after primary repair of large hiatal hernias reach 42 %. Mesh~     repair decreases rates of failures, however, polypropylene and composite PTFE meshes used~     most widely, result in unacceptable rates of long-term dysphagia and oesophageal strictures.~     Our own experience of more than 400 repairs using partially absorbable lightweight mesh~     Ultrapro (Ethicon) and original sub-lay technique of its fixation precluding contact of the~     mesh with the oesophagus, showed low recurrence rate and a few cases of long-term dysphagia.~     Thus, final conclusions could be established by prospective randomized study. Our hypothesis~     is: original technique of lightweight mesh repair is highly effective for prevention of~     recurrences compared to primary repair and safe in terms of mesh-related dysphagia and~     oesophageal strictures. The long-term results (24 months post surgery for every patient) will~     be studied using symptom questionnaires, quality of life and satisfaction questionnaires,~     barium studies, endoscopic examinations, 24-hour pH testing, and analysis of possible~     reoperations.~   "
164840|NCT01408095|"~     The study is designed to see if once daily oral dosing of LY2608204 will help control~     diabetes as measured by the glycosylated fraction of hemoglobin A (HbA1c) level. It will also~     help to determine the safety of the medication and the most useful doses of the medication.~   "
164841|NCT01408082|"~     The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared~     to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with~     Non-bacterial Blepharitis.~   "
164842|NCT01408069|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different associations of drugs in the treatment of patients diagnosed with tensional-type~     headache in accordance with International Headache Society guidelines.~   "
164843|NCT01408056|"~     The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe~     and effective in promoting wound healing of infantile ulcerated hemangiomas compared with~     standard conservative management with topical antibiotic.~   "
164844|NCT01408043|"~     This clinical trial studies etoposide, filgrastim and plerixafor in improving stem cell~     mobilization in patients with non-Hodgkin lymphoma. Giving colony-stimulating factors, such~     as filgrastim, and plerixafor and etoposide together helps stem cells move from the patient's~     bone marrow to the blood so they can be collected and stored.~   "
164845|NCT01408030|"~     The purpose of the NOSE Study is to carefully examine the efficacy and safety of 3 nasal~     sprays (bevacizumab, estriol, and tranexamic acid), compared to placebo, for the treatment of~     HHT related nosebleeds.~   "
164846|NCT01408004|"~     In this study will be examined whether alternating treatment between two classes of drugs~     (TKI's and m-TOR inhibitors) postpones or prevents drug resistance in patients with renal~     cancer.~   "
164847|NCT01407991|"~     The purpose of this study is to compare two methods of nasogastric/oral gastric (NG/OG) tube~     placement for efficacy and safety in the placement of NG/OG tube in infants less than 6~     months of age. One method is based on the infant's length determined by measurement using a~     length board and plotted on a graph derived from a formula to determine the depth for tube~     insertion (graph method) and the other method is based on current standard of care, measuring~     from the nose to the ear and then the ear to mid abdomen (NEM) and mark the tube to know how~     far to insert the tube. Outcome comparison will be xray verification of placement.~   "
164848|NCT01407978|"~     This is a single-blind, reference drug controlled study to assess safety and tolerability of~     FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn~     phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents. To~     assess, as secondary objective, the efficacy (immunogenicity) of the vaccine by serology~     testing.~   "
164849|NCT01407965|"~     Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.~   "
164850|NCT01407952|"~     This research study is being done to test the effectiveness of a new generation FDA approved~     device for treating aneurysms compared to the current standard device for endovascular~     aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of~     minimally invasive surgery, which is performed on blood vessels. The technique involves the~     introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the~     skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery found~     near the groin. The catheter is then maneuvered through the body to the location of the~     aneurysm in the brain using image guidance. Coils are delivered into the aneurysm through the~     catheters. Once the coils are delivered in the aneurysm, they are detached from the catheter.~     This is repeated until enough coils fill the aneurysm, blocking the blood flow to the~     aneurysm. The body responds by forming blood clots around the coil(s), which helps block the~     flow of blood into the aneurysm and keeps the vessel from rupturing or leaking. This study~     will compare the study device to the standard bare platinum coil to see which is better at~     preventing future rupturing or leaking. The study device is called the HydroCoil Embolization~     System and this study is a post-market clinical trial.~      About 600 subjects from multiple institutions will take part in this study.~   "
164851|NCT01407939|"~     This proposal describes 2 basic research studies that will be conducted sequentially. Study 1~     will test the efficacy of both classic and newly developed generally recognized as a safe~     (GRAS) bitter blockers on the perceived bitterness and acceptance of different classes of~     bitter-tasting compounds by children and compare their responses to adults. Because~     variations among and between children and adults in terms of sensitivity to different bitter~     compounds are due in part to genetically determined receptor variation, the investigators~     will consider genotype when assessing how well bitter blockers perform. In Study 2, the~     investigators aim to evaluate different methods (forced-choice procedures, hedonic face~     scales) used for testing children to determine their reliability and reproducibility.~   "
164880|NCT01407562|"~     This is an open label, dose escalation study to determine the safety and tolerability and~     maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in~     patients with advanced solid tumors.~   "
164852|NCT01407926|"~     Objective: The objective of this study is to evaluate the feasibility, acceptability and~     effectiveness of a 6-month nurse-led, interprofessional mental health promotion intervention~     aimed at older home care clients with depressive symptoms using personal support services.~      Methods/Design: This one-group pre-test post-test study aims to recruit a total of 250~     long-stay (> 60 days) home care clients, 70 years or older, with depressive symptoms who are~     receiving personal support services through a home care program in Ontario, Canada. The~     nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that~     involves regular home visits, monthly case conferences, and evidence-based assessment and~     management of depression using an interprofessional approach. The primary outcome is the~     change in severity of depressive symptoms from baseline to 6 months using the Centre for~     Epidemiological Studies in Depression Scale. Secondary outcomes include changes in the~     prevalence of depressive symptoms and anxiety, health-related quality of life, cognitive~     function, and the rate and appropriateness of depression treatment from baseline to 12~     months. Changes in the costs of use of health services will be assessed from a societal~     perspective.~   "
164853|NCT01407913|"~     The study hypothesis is that caudal epidural steroid injections provides short term relief to~     patients with persistent low back pain and sciatica due degenerative disc disease or lumbar~     spinal stenosis. Patients will be evaluated wiht clinical examination and radiological~     examinations before injections. They will be followed up with questionnaires on pain and~     disability up to 6 months postinjection.~   "
164854|NCT01407900|"~     The overall aim is to conduct a human physiologic study to assess the renal and neurohumoral~     effects of CD-NP vs placebo in older subjects with stable chronic systolic heart failure and~     moderate renal dysfunction.~   "
164855|NCT01407887|"~     Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for~     falciparum malaria treatment in African children: randomised controlled trial.~      Design: Mono-centre, two arms, open randomized controlled study in children with~     uncomplicated falciparum malaria in Burkina Faso.~      Phase: Phase II.~      Objectives: The primary objective of this trial is to study the efficacy and safety of the~     triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days~     in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local~     standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.~      Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna~     Hospital in north-western Burkina Faso.~      Sample size: 180 patients (90 per study arm).~   "
164856|NCT01407874|"~     To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol~     in subjects with moderate renal insufficiency.~   "
164857|NCT01407861|"~     This is a single centre, open label, prospective, randomized study on the prophylactic effect~     of moderate aerobic endurance training versus relaxation training in patients with migraine.~   "
164858|NCT01407848|"~     In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and~     term neonates with Transient Tachypnoea.~   "
164859|NCT01407835|"~     The objective of this study is to determine the biologic activity of a Dactylis glomerata~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
164860|NCT01407822|"~     Stage IIIA NSCLC represents a relatively heterogeneous group of pts with ipsilateral~     mediastinal (N2) lymph node involvement. The relative roles of treatment modalities are not~     clearly defined. Concurrent chemoradiation therapy remains an important treatment for stage~     IIIA disease, but its treatment-related life threatening toxicity limits its use. The EGFR~     tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary~     adenocarcinoma carrying EGFR activating mutations in the metastatic setting. In the OPTIMAL~     study, first-line erlotinib versus carboplatin/GEM in advanced NSCLC pts with EGFR activating~     mutations, the primary analysis showed significantly prolonged progressive free survival~     (PFS) was with erlotinib vs carboplatin/GEM (p<0.0001). The aim of this study is to~     investigate the efficacy and safety of erlotinib versus GEM plus cisplatin (GC) as~     neoadjuvant treatment in pts with stage IIIA-N2 NSCLC with EGFR activating mutations and to~     explore a new treatment strategy for this subset.~   "
164861|NCT01407809|"~     Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and~     is associated with headache and loss of vision. The medical and surgical management of IIH is~     problematic and many patients are not treated effectively. Some cases of IIH are associated~     with severe stenosis of the large veins of the brain and various researchers have recently~     reported significant improvement in patients with IIH after the narrow veins of the brain~     were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of~     venous sinus stenting in patients with severe IIH refractory to medical management.~   "
164862|NCT01407796|"~     The overall purpose of this research is to gain understanding of the basic responses of the~     lung to inflammation. Inflammation is the way our bodies react to irritation or injury, and~     involves red, warm, and often painful swelling of the affected tissue. Acute lung injury~     involves a generalized inflammation to the lung that is activated by any of several~     conditions: infection, trauma, inhalation of toxic substances, etc. When lung injury is~     severe, not enough oxygen can get into the body; this can lead to the need for mechanical~     support of breathing (mechanical ventilation), problems with brain, heart or other organ~     function, and in some cases, death. Inducible nitric oxide synthase (iNOS) contributes to the~     development of lung inflammation.~   "
164863|NCT01407783|"~     NUMOMS involves collaboration between Nurses for Newborns Foundation and Washington~     University in St. Louis. This study explores the co-location of depression treatment within~     nurse home visitation and the organizational changes needed to maintain access to~     evidence-based treatment. Problem Solving Tools (PST) was chosen as the depression treatment~     because it is well suited for use by non-mental health specialists and for in-home treatment.~     It is also a brief treatment (4-8 sessions) takes a non-pathologizing approach.~   "
164864|NCT01407770|"~     RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Radiation therapy~     may cause skin reactions when patients are exposed to high-energy x rays. Studying the~     genetic pattern of patients before and after radiation therapy may help doctors prevent~     toxicity and plan the best treatment.~      PURPOSE: This clinical trial studies genetic susceptibility to radiation-induced skin~     reactions in racial/ethnic groups of patients with breast cancer.~   "
164867|NCT01407731|"~     RATIONALE: Studying protein expression in samples of tumor tissue from patients with cancer~     in the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat~     neuroblastoma.~      PURPOSE: This laboratory studying is looking at protein expression in tumor tissue samples~     from patients with neuroblastoma.~   "
164868|NCT01407718|"~     This project will address the incidence of anterior knee pain in the approaches used for~     tibial nailing. A parapatellar approach, with nail insertion in relative extension, will be~     compared to the approaches in which nail insertion requires the knee to be placed in flexion.~     The incidence of anterior knee pain will be compared in each group to assess whether the~     compared approaches result in similar levels of anterior knee pain. Patients will be given~     the 2000 IKDC Subjective Knee Evaluation Form to assess anterior knee pain. The 2000 IKDC~     Subjective Knee Evaluation Form is a newer assessment tool created by the International Knee~     Documentation Committee. It has been validated for use with broad patient populations dealing~     with various knee disorders.19~   "
164869|NCT01407705|"~     The investigators propose a prospective study, designed to analyze the efficacy of~     High-Resolution Diffusion Tensor Imaging for accurately sensing white matter tracts in~     subjects with spinal cord injury. Study subjects will not be randomized, as treatment will~     follow the doctor's standard of care. Patients will be selected and offered enrollment~     based upon the clinical diagnosis of spinal cord injury, either due to degenerative disease~     or trauma. Enrollment will be based on the chronology of patient presentation.~   "
164870|NCT01407692|"~     The purpose of this study is to determine if the phase of the menstrual cycle (opposed versus~     unopposed estrogen phase) affects eating behavior, including types of foods preferred,~     wanting/desire for specific foods, and perception of hunger.~   "
164871|NCT01407679|"~     To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE~     with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area~     and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of~     treatment or at the latest assessment for patients who withdrew prematurely. Response is~     defined as a reduction of 50% in the total RCLASI compared to the baseline value (RCLASI~     50).~   "
164872|NCT01407666|"~     This prospective, randomized study is intended to assess the efficacy and safety of bilateral~     continuous paravertebral blocks compared to continuous epidural block for open liver~     resection. Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in~     controlling the perioperative pain; and 2) safe, with less frequent complications following~     open liver resection when compared to continuous epidural block.~   "
164873|NCT01407653|"~     Chronic low back pain and sciatica in adults represent a major medical and economic problem.~     During the chronic back pain (persisting continuously over 3 months), therapeutic responses~     to conventional pharmacologic type are often ineffective and the impact of pain is often~     heavy in terms of disability, social and professional avulsion and loss of quality of life.~     This failure has led in recent years to propose innovative strategies such as application of~     relaxation therapy techniques. An example is a virtual reality which is a technology to~     immerse someone in a 3D virtual environment. Our hypothesis is that the hypnotic suggestion~     combined with virtual reality can be effective on chronic pain. The main purpose is to~     measure the impact on the intensity of pain at 4 months after using of a new method for~     virtual environment, mimicking the colors from low to high frequencies (World Patent Filed,~     WO2007/057601) in patients with chronic disabling low back pain and sciatica resistant to~     therapeutic drugs.~   "
164874|NCT01407640|"~     Insulin allergy (IA) is still observed even with recombinant human insulin and insulin~     analogs.~      Obviously, the usual attitude facing an allergy, i. e. exclusion of the allergen, poses~     problems in face of IA because insulin is often vital for the patient. IA is thus a complex~     situation in which a rigorous diagnostic procedure to identify the exact allergen is~     necessary to propose a therapeutic answer; the purpose of the study is 1/ to validate a~     diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate~     immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA.~   "
164875|NCT01407627|"~     Fructose is an ingredient that is added to many of our foods. It is a cheaper, sweeter~     additive that can be found in everything from soda pop to yogurt to granola bars. In the last~     few years a significant number of studies have been published linking consumption of fructose~     with obesity, hypertension and more recently, kidney and cardiovascular disease.~      Animal studies show a strong link between excessive ingestion of fructose and the development~     of kidney and cardiovascular disease mediated by the renin angiotensin system, a hormonal~     system whose activation is detrimental to both the kidney and the heart. There has been very~     little research done on the potentially pathophysiological relationship between a high~     fructose diet and kidney and cardiovascular disease in humans.~      The investigators hypothesize that ingestion of fructose will result in upregulation of the~     renin angiotensin system in humans.~   "
164876|NCT01407614|"~     In a prospective randomized controlled trial, the investigators aim to assess whether~     external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its~     sequelae in patients with an aneurysmal subarachnoid hemorrhage.~   "
164877|NCT01407601|"~     Vascular calcification (VC) is a predictor of cardiovascular morbidity and mortality.~     Hemodialysis (HD) patients suffer from severe vascular calcifications. Matrix Gla protein~     (MGP) is a central calcification inhibitor of the arterial wall and its activity depends on~     vitamin K-dependent γ-glutamate carboxylation. Noncarboxylated MGP, formed as a result of~     vitamin K deficiency, is associated with cardiovascular disease. Recent studies pointed~     towards poor vitamin K status in HD patients. We therefore aim to investigate whether daily~     vitamin K2 (MK-7) supplementation improves the bioactivity of vitamin K-dependent proteins in~     HD patients as assessed by circulating dephospho-noncarboxylated MGP (dp-ucMGP),~     noncarboxylated osteocalcin (ucOC) and noncarboxylated prothrombin (ucFII; PIVKA-II).~   "
164878|NCT01407588|"~     The purpose of this study is to compare manual and magnetic navigation in ablation for atrial~     fibrillation.~   "
164879|NCT01407575|"~     The purpose of this study is to compare the safety and efficacy of buprenorphine with placebo~     for adults with treatment resistant depression (TRD).~   "
164926|NCT01406964|"~     The aim of this study is to evaluate the usefulness of a Chlamydia Antibody Test for~     screening of tubal factor in patients who undergo artificial insemination.~   "
164881|NCT01407549|"~     Background: Chronic pain is a common condition in the general population, causing great~     suffering in both physical and mental aspects. Previous research shows that mindfulness based~     interventions help chronic pain patients to cope better with their pain, and improve their~     quality of life. Although evidence support the efficacy of mindfulness based interventions~     for chronic pain, it is still unclear whether this efficacy involves a direct influence on~     sensory aspects of pain perception. Further more, the mechanisms of change responsible for~     the improved life quality and the possible moderating factors that may influence treatment~     efficacy, are still unknown.~      Aim: The purpose of this study is to evaluate the efficacy of mindfulness based intervention~     on pain perception and quality of life in individuals suffering from chronic pain. The~     investigators will also evaluate potential mechanisms responsible for the change following~     mindfulness practice. Finally the investigators will examine the role of personal~     characteristics as potential moderating factors of mindfulness effect.~      Hypothesis: The investigators hypothesize that 1) compared to a waitlist control group,~     chronic pain patients participating in a full mindfulness based program will report greater~     improvements in a) pain severity, b) quality of life and psychological symptoms, and c) will~     demonstrate changes in physiological characteristics of pain. 2) Changes following the~     mindfulness based program will be mediated by change in pain catastrophizing, self regulation~     capacity and pain acceptance. 3) The investigators hypothesize that gender, baseline~     mindfulness, and anxiety sensitivity will moderate the efficacy of the mindfulness based~     program.~      Method: A randomized controlled design will be used to evaluate the efficacy of mindfulness~     based intervention on pain perception and quality of life in individuals suffering from~     chronic recurrent low back pain and osteoarthritis. Participants will be randomized to a~     mindfulness based treatment group, or to a waitlist control group, and will be assessed for~     psychological variables and psychophysical pain assessment before treatment. Participants~     allocated to treatment group will then attend six group meetings in which they will learn and~     practice different mindfulness meditation techniques, and will be asked to practice these~     techniques on a daily basis. Post treatment assessments will take place at the end of the~     intervention for both treatment and control groups.~   "
164882|NCT01407536|"~     Functional magnetic resonance imaging (fMRI) has confirmed that thermal stimulation (TS) may~     facilitate cortical excitability in healthy adults. However, it is unknown whether TS can~     increase cortical excitability in stroke patients. Compared to the fMRI, the transcranial~     magnetic stimulation (TMS) possesses more concise conditions in temporal resolution, and it~     can present the cerebrum activation situation more instantaneously. This study aimed to use~     TMS examining the effect on corticomotor excitability, reorganization and functional motor~     recovery after TS on affected upper limbs of chronic stroke patients.~   "
164883|NCT01407523|"~     To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as~     adjunctive treatment in subjects with Partial Onset Seizures after switching from the~     equivalent Levetiracetam oral dose.~   "
164884|NCT01407510|"~     A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat~     0.1% ointment in Japanese adults with atopic dermatitis.~   "
164885|NCT01407497|"~     While antiretroviral drugs have shown great promise in reducing HIV replication and thus in~     reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial~     and side effects are a potentially limiting factor. Development of an effective~     safe-affordable vaccine is likely to be the best way to stop further virus spread. The study~     aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg~     delivered id in combination with MVA-CMDR boost im.~   "
164886|NCT01407484|"~     BACKGROUND: One couple out of 6 consults for infertility during their sexual life. In 60% of~     cases a male factor is associated or is the main infertility factor. Inflammatory Syndrome~     (IS), characterized by the presence of a leukocytospermia is found in 12% of the cases.~     Leukocyte degranulation causes oxidative stress (OS) through the formation of free radicals~     attacking the sperm cell functions.~      HYPOTHESIS: To establish the responsibility of the IS, and OS, in chronicle inflammatory male~     infertility, the investigators hypothesize that its treatment (as well as its possible cause)~     must restore or improve the fertilizing capacity of patients sperm.~      METHODS: This prospective randomized study will test the response to the treatment. The~     investigators shall measure cellular degradation products due to the OS, thereby certifying~     that it does have a deleterious effect on sperm cell. Seminal biochemistry will also assess~     the impact of the syndrome on the genital tract glands and follow its evolution.~      The patients will be included in the study as soon as the leukocytospermia will be >~     0,5*106/ml or as soon as the elastase will be > 500 ng/mL.~      The examinations will be performed using flow cytometry, CASA (Computer Assisted Semen~     Analysis). The analysis of sperm morphology will be centralized.~      Primary endpoint will be a reduction in the percentage of 8OH-dG below 35 %. We anticipate~     that it should arrive to 20 % of the patients included in the arm treatment by corticosteroid~     therapy. All in all will thus be needed 50 patients in the group placebo and 50 in the group~     treated.~      Secondary endpoint the improvement of the spermatic parameters and the reduction of the~     fragmentation of the DNA of sperm cells to the treated subjects.~      All these biological markers will be evaluated 6 month after the treatment:~        -  Fragmentation of the spermatic DNA below 37 % during the follow-up in 6 months~        -  Leukocytospermia and elastase~        -  Seminal biochemistry~        -  Other markers of the inflammatory syndrome and oxidative stress (protein carbonyl,~          8OHd-Guanosine)~        -  Possibly the radiological examinations (Ultrasound and MRI of the genital tract)~      In addition it would allow us to propose a policy of prevention towards acquired~     post-infectious male infertility.~   "
164887|NCT01407471|"~     The purpose of this study is to determine whether spironolactone could significantly reduce~     cutaneous atrophy due to corticosteroids.~   "
164888|NCT01407458|"~     To examine the impact of a structured physical activity program focused on bone strength in~     elementary school children in the framework of their physical education classes on:~        1. Bone strength of children participating in the activity.~        2. Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal~          jumping strength, static balance, dynamic balance and coordination.~   "
164889|NCT01407445|"~     Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.~   "
164890|NCT01407432|"~     Unexplained male infertility is increasing, and, nowadays, the investigators only can propose~     palliative treatment, as In VITRO Fertilization (IVF). The folate metabolism is a key for the~     maintenance of genome integrity. A dysfunction in this pathway can be responsible of~     spermatogenesis defects, and further, of infertility. Few assays have shown that folate~     treatment can improve sperm parameters and fertility, till 30% in some of theses studies. The~     purpose of the investigators study is to demonstrate the impact of folates treatment on~     improvement of sperm parameters and on the rate of success of in VITRO fertilization~     procedures.~   "
164891|NCT01407419|"~     The Treat to Target Trial is a clinical trial available to new and existing CORRONA (Data~     Collection Program) sites. Subjects are recruited to participate in this 12 month trial~     examining outcomes and feasibility of implementing a Treat to Target approach, when compared~     with a control group of subjects treated with usual care.~   "
164892|NCT01407406|"~     Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese~     populations to support future clinical development of BIIB023 in China and Japan.~      Study Design: This is a single-dose study to assess the PK, safety, and tolerability of~     BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy~     volunteers. The Caucasian group is included to allow comparison of PK data from different~     groups using data from the same study under the same controlled conditions.~      Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up~     to 100 days.~   "
164927|NCT01406951|"~     Aims: to explore the value of TREM-1 (triggering receptor expressed on myeloid cells-1)~     ,PCT(Procalcitonin), as well as CPIS (clinical pulmonary infection score) in the diagnostic~     and prognostic assessment of VAP (ventilator associated pneumonia); and to make a comparison~     with WBC (white blood cells) and CRP (C-reactive protein) level as well as SOFA (Sequential~     Organ Failure Assessment) Score Methods: There were 92 subjects of sepsis, who were either~     receiving endotracheal intubation or had undergone tracheotomy and were exposed to mechanical~     ventilation. The subjects were divided into the VAP group (32) and the Non-VAP group (60),~     the criterion being the contraction of VAP 48 hours after ICU admission. Etiological culture~     was conducted in BALF (bronchoalveolar lavage fluid). And sTREM-1 density was determined by~     examining serum sTREM-1, PCT, WBC, CRP and EVC (exhaled ventilator condensate). Meanwhile,~     the CPIS and SOFA score were worked out. With a 28-day survival as the demarcation line, the~     VAP group was further divided into the survivors group, who stayed alive for 28 days or more~     , and the non-survivors group, who died within 28 days. The sTREM-1 and PCT level were~     denoted as meridians (range interquartile), while the WBC and CRP level as well as the CPIS~     and SOFA score, means±standard deviations (SD).~      Results: Averagely, the patients would contract clinically-confirmed VAP 6.9 days after~     admission, which was mainly traced to Gram-negative bacilli infection. On the very day of~     diagnosis, compared with the Non-VAP group, the VAP group showed a higher level of serum~     sTREM-1, PCT, WBC and CRP as well as CPIS and SOFA score（295.6pg/ml vs.143.5pg/ml,~     P<0.001；4.5ng/ml vs. 1.4ng/ml，P=0.008；16.7×10∧9/L vs.10.9×10∧9/L, P<0.001；11.5mg/dl vs.~     7.7mg/dl，P=0.012； 6.0vs. 1.9, P<0.001；10.0vs. 7.5, P=0.017）, AUC (area under the receiver~     operating characteristic curve）turned out as follows :sTREM-1: 0.73（95% CI 0.61-0.85）;PCT :~     0.70（95% CI 0.57-0.83）;WBC: 0.73（95% CI 0.60-0.85）.The CPIS score, which was proved by~     logistic regression analysis as the sole risky factor to VAP, amounted to 0.96（95% CI~     0.91-1.00）. Combined prediction probability containing all the data was calculated in~     accordance on the relative regression equation. sTREM-1+WBC+CPIS score proved to be most~     reliable for diagnosis. AUC turned out as 0.98. With 0.277 as the cut-off point, sensitivity~     measured 0.97, specificity, 0.9 and YDI, 0.87. There were only 5 VAP subjects whose sTREM-1~     density could be detected in EVC. The VAP patients were divided into a survivors group (n=15)~     and a non-survivors group (n=17) with a 28-day survival as the demarcation line. The~     non-survivors group demonstrated a higher PCT level and higher CPIS & SOFA score than the~     survivors. （3.0ng/ml vs. 15.3ng/ml，P=0.032；5.4vs. 6.6, P=0.03；8.1vs.11.7 P=0.049). AUC worked~     out PCT 0.752（95% CI 0.547-0.956）and CPIS 0.764（95% CI 0.575-0.953）. Calculations on the~     regression equation showed the PCT+CPIS score was most reliable for prognostic assessment.~     AUC turned out as 0.848. With 0.516 as the demarcation line, sensitivity measured 0.867,~     specificity, 0.818 and YDI, 0.685.~      conclusion: WBC + CPIS helps improve VAP diagnosis; PCT+CPIS may be used for VAP prognostic~     assessment. Taking two items into consideration will be of guiding value in VAP treatment as~     well as mortality rate reduction. The sTREM-1 level in EVC，however，may be devoid of value for~     VAP diagnosis.~   "
164928|NCT01406938|"~     This study will assess the safety and efficacy of two different doses and two different dose~     regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic,~     plaque-type psoriasis.~   "
164893|NCT01407393|"~     Glucosanol™, the medical device to be investigated contains a proprietary plant extract that~     is a natural inhibitor of alpha-amylase and can reduce starch digestion.~      The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body~     weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the~     efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.~   "
164894|NCT01407380|"~     This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and~     clinical effects of orally administered PWT33597 mesylate in subjects with advanced~     malignancies.~   "
164895|NCT01407367|"~     Chronic kidney disease (CKD) is common, but it is often over-looked in patients with this~     disease when they are getting medical treatment. Patients with CKD have special needs for~     their medical treatment. When these special needs are not considered their medical care may~     lead to unintended harm (called safety events) which can cause hospitalization, more kidney~     problems, and even death.~      This research study has two purposes. The first purpose is to determine how participants feel~     about wearing a medical alert bracelet or necklace that alerts health care workers that the~     user of the bracelet or necklace has decreased kidney function. Medical alert bracelets are~     often recommended for people who have other medical problems, such as diabetes. This medical~     alert bracelet or necklace has an address to an informational website about the safe care of~     patients with kidney problems. The investigators think that alerting health care workers that~     a person has decreased kidney function may decrease their chances of having a medical injury~     and improve the safety of their care.~      The second purpose of this research study is to track how often people with kidney problems~     may be exposed to medicines, tests, or procedures that might increase their chance of having~     an accidental medical injury or safety event. Though some medical injuries can not be~     prevented, the investigators want to find out what medical events in patients with kidney~     problems might be preventable. The investigators also want to find out if other things might~     increase a patient's chances of getting a medical injury, such as physical weakness or~     medical instructions that might be confusing.~   "
164896|NCT01407354|"~     Many people with spinal cord injury (SCI) hold some ability to move their leg muscles, and~     are therefore considered to demonstrate a motor incomplete injury. After such a spinal cord~     injury, individuals are able to walk less both in their home and in their community.~     De-conditioning, or a lack of endurance and fitness also occurs. Several methods are~     available to try to improve walking ability and the fitness of persons with motor incomplete~     spinal cord injury. This study examines two of these methods. The first is the use of~     robotically assisted body-weight supported walking using a device called the Lokomat. The~     second is aquatic or pool-based exercise. The investigators are researching the impact of~     these two techniques on walking ability and fitness in people who experienced motor~     incomplete spinal cord injury for at least 12 months.~   "
164897|NCT01407341|"~     This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients~     undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth~     in patients undergoing surgery for spine cancer~   "
164898|NCT01407328|"~     During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the~     shoulder and trachea, compressing the upper airway. Although the extravasation is generally~     reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or~     life-threatening complications. Furthermore, the soft tissue edema around the shoulder may~     extend to the thoracic cage, compress the chest and induce the respiratory distress~     immediately after surgery. The investigators attempt to determine the effect of shoulder~     arthroscopic surgery on respiratory mechanics. Changes in respiratory mechanics and arterial~     blood gases were measured and compared before and after the shoulder arthroscopic surgery.~   "
164899|NCT01407315|"~     Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped~     with the GlucoMen®Day system, over up to 100 hours observation after implantation of the~     microdialysis probe. Different meal/hypo procedures will be performed at the study centre.~   "
164900|NCT01407302|"~     Recently, laryngeal mask airway (LMA) placements are frequently performed for general~     anesthesia. The investigators occasionally encounter a clinical situation to perform internal~     jugular vein (IJV) cannulation after LMA insertion, especially for difficult airway in~     subjects undergoing major surgery. However, anatomic relations of IJV and common carotid~     artery (CCA) in patient with LMA placement have been reported to be different from those in~     patients with endotracheal tube. The degree of overlapping of the right IJV and CCA after LMA~     placement was greater than before LMA placement. Furthermore, there are many cases of~     complete overlapping right IJV and CCA after LMA placement. Therefore, the risk of puncturing~     CCA increases when the investigators try to cannulate IJV after LMA placement. Furthermore,~     the central landmark commonly used for IJV cannulation was proved to show low success rate~     after LMA placement in previous report.~      The investigators carefully examined the anatomic relations of IJV and CCA after LMA~     insertion with ultrasonography, and found that the degree of overlapping is different~     according to the degree of head rotation. The investigators postulated that if the degree of~     overlapping is different according to the degree of head rotation after LMA insertion, the~     investigators can find the angle of head rotation for least overlapping and reduce the risk~     of CCA puncture. Therefore, the investigators tried (1) to find the optimal head rotation~     angle appropriate for puncturing IJV after LMA placement, and (2) to find suitable landmark~     adequate for IJV cannulation after LMA placement.~   "
164901|NCT01407289|"~     The purpose of the study is to compare the efficacy of enhanced published best practice~     paper-based insulin titration protocol for glycaemic control in hospitalised patients with~     type 2 diabetes for the length of hospital stay.~   "
164902|NCT01407276|"~     This is a 2-part study in participants with renal impairment and matched healthy participants~     to investigate the effect of impaired renal function on the plasma and urine levels of~     omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.~   "
164929|NCT01406925|"~     This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of~     NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.~   "
165000|NCT01405989|"~     The primary objective of this study is to determine the effect of ketoconazole on the blood~     concentrations of darexaban and its metabolites (drug degradation products). The secondary~     objective of the study is to evaluate the safety and tolerability of a single dose of~     darexaban alone and when administered together with ketoconazole.~   "
164903|NCT01407263|"~     This study aims to determine how different ways of performing prostate cancer surgery affect~     patient outcomes, such as recurrence of cancer or regaining control of bladder function~     (continence) after surgery. Surgery to remove the prostate is known as a radical~     prostatectomy. Surgeons know many things about the best way to do a radical prostatectomy.~     However, there is uncertainty about some methods of surgery.~      All of the surgeons who are taking part in this study have used these techniques at different~     times. However, they are unsure as to what is the best approach. This trial will evaluate~     whether the following two aspects of surgical technique influence outcome:~      Lymph node template. Prostate cancer can sometimes spread to the lymph nodes near the~     prostate. Surgeons often remove these lymph nodes to make sure that no cancer is left in the~     body. However, there is uncertainty about which lymph nodes to remove (the template). In~     particular, not all surgeons think that it is important to remove a large number of lymph~     nodes. Some believe that prostate cancer found in the lymph nodes is not aggressive. As a~     result, these surgeons feel that removing additional lymph nodes does not improve the chance~     that a patient will be cured. In the study patients will either have the standard lymph node~     dissection or a modified approach.~      Port site incision. Some surgeries are conducted with the help of what is called a surgical~     robot, or using a laparoscopic approach (sometimes known as keyhole surgery). The~     surgeons have to make small cuts (incisions) in order to insert their surgical instruments.~     Some surgeons believe that the way in which this cut is made can affect the chance that a~     patient will develop a hernia in the months after surgery. This is when tissues in the~     abdomen protrude through the incision, creating a small bulge that has to be surgically~     corrected. In the study, patients will either have the incision made vertically or~     horizontally.~      Antibiotics. About a week after surgery, you will return to the hospital to have your~     catheter removed. To guard against the chance of infection, you will be given antibiotics.~     These do help prevent infection, but are also harmful. Doctors are unsure whether to give a~     short course of antibiotics or whether patients really need several days of treatment. In the~     study, patients will receive antibiotics for either one or three days.~   "
164904|NCT01407250|"~     Comparison of the quality of the outpatient clinic electrocardiogram performed on patients~     sent to a cardiology consultation with a standard cable and the PhysioGlove-ES~     electrocardiograms performed in the cardiology clinic.~   "
164905|NCT01407237|"~     The purpose of this study is to see if individuals with HIV-infection, particularly those~     with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis.~     Renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the~     body, and they may also have effects on sugar metabolism and cardiovascular health. There is~     some evidence that individuals with HIV-associated abdominal fat accumulation may have~     increased aldosterone, which may contribute to abnormalities in sugar metabolism and~     increased cardiovascular disease seen in HIV. The purpose of this study is the measure renin,~     angiotensin, and aldosterone activity, as well as other hormonal axes, in people with and~     without HIV infection, and with and without increased belly fat. The investigators~     hypothesize that aldosterone will be increased in HIV-infected individuals compared to those~     without HIV-infection, and that aldosterone will be further increased in HIV-infected~     individuals with increased abdominal fat compared to those without abdominal fat~     accumulation.~   "
164906|NCT01407224|"~     The aim of this operational research is to compare the cost-effectiveness of two methods for~     capacity building of existing TBAs/CVs to improve rates of delayed cord clamping, early skin~     to skin contact and infant-led initiation of breastfeeding, to reduce prelacteal feeding and~     increase early exclusive breastfeeding in research areas of rural Bangladesh.~   "
164907|NCT01407211|"~     The aim of this study is the comparison between the effects of supplementation with vitamin A~     (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in~     multiple sclerotic patient.~   "
164908|NCT01407198|"~     The study drug, Nilotinib, is believed to slow down tumor growth by regulating a gene~     involved in cellular growth of chordoma cells. During this research study, subjects will also~     receive radiation therapy which is considered a standard treatment for advanced chordomas. It~     is hoped by adding nilotinib, the benefits of radiation therapy can be enhanced without~     adding significant toxicities.~      The purpose of this research study is to determine the safety of nilotinib when used in~     combination with radiation therapy, and the highest dose of nilotinib that can be given~     safely with radiation therapy.~   "
164909|NCT01407185|"~     The purpose of this study is to determine the efficacy of a multi-disciplinary home program~     consisting of specific education and home-based individualized combined aerobic and~     resistance training exercise program for persons with heart failure (NYHA class II-III). The~     investigators will assess effects on endurance, gait speed, lower extremity strength,~     hospital re-admission rate and the quality of life in community-dwelling older adults from 60~     - 85 years of age over a 12 month period.~      Anticipated Results: The researchers expect confirm their hypothesis that there will be a~     statistically significant difference between the experimental group receiving the combined~     aerobic and resistance training program and the control group receiving usual care based on~     strength, endurance, quality of life, falls, and hospital re-admission data.~   "
164910|NCT01407172|"~     This will be an observational study comparing the plasma levels of free hydrogen sulfide in~     patients with and without peripheral arterial disease using a novel recently published method~     of measuring hydrogen sulfide. The investigators will also see if there is any difference in~     these levels between symptomatic and asymptomatic patients. Will examine the relationship of~     these levels to known clinical risk factors as well as plasma nitrite and nitric oxide~     levels. In doing the above the investigators hope to explore the utility of free hydrogen~     sulfide as a biomarker for peripheral arterial disease.~      Atherosclerotic peripheral arterial disease (PAD) of the lower extremities represents a~     significant and growing cause of morbidity and mortality. The PARTNERS study of screening~     ABIs in a primary care population of nearly 7000 individuals demonstrated a remarkable 29%~     incidence of ABI <0.9, which is the commonly accepted level of abnormal ABI diagnostic of~     PAD. Also of note in these patients with a new diagnosis of PAD the incidence of asymptomatic~     PAD was a striking 48%. The availability of a biomarker will greatly enhance the care of~     these patient and hopefully reduce morbidity and mortality.~      The investigators believe that hydrogen sulfide (H2S), an endogenously produced~     gasotransmitter, holds promise as a clinically useful biomarker for PAD and may also provide~     a possible explanation for the paradox of asymptomatic PAD in patients with ABIs less than~     0.9. To date, research regarding H2S has demonstrated that it participates in a myriad of~     physiological functions including vasodilatation, anti-apoptotic effects, modulation of~     mitochondrial respiration, and changes in vascular remodeling.~   "
164911|NCT01407159|"~     Cohort study according to national regulatory guidelines: Non-interventional, observational~     cohort study. Pair-matched comparison with patients chosen from historical series.~      To evaluate the clinical and technical success as well as the safety and feasibility of the~     E-XL aortic stent used in complicated type B aortic dissection in addition to a classic~     stentgraft in a single procedure.~   "
164945|NCT01406704|"~     This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic~     acid, antioxidant on patients with pathologically proved NASH (non-alcoholic~     steato-hepatitis).~   "
164912|NCT01407146|"~     The primary aim of this study is to increase our understanding of care-seeking behavior~     surrounding heart attacks or acute coronary syndromes [ACS]. This study uses an internet~     based survey to ask individuals how they obtained medical care in the midst of a heart~     attack. At present, care-seeking delay among individuals stricken with a heart attack~     prevents them from obtaining the full therapeutic benefit of hospital based medical care in a~     timely manner to reduce the long term health consequences of a heart attack. By using a~     self-tailoring survey instrument the study attempts to take into consideration the complex~     social processes by which the individual and their family make decisions to seek medical care~     for symptoms of a heart attack. The study is designed to obtain a national sample of ACS~     care-seeking behavior in the United States.~   "
164913|NCT01407133|"~     The objective of the investigators study is to assess conventional repetitive transcranial~     magnetic stimulation (rTMS) in patients with chronic severe tinnitus. A randomized,~     double-blind, sham-controlled procedure, with four increasing levels of magnetic~     pseudo-dose has been designed, in order to characterize the effectiveness of rTMS while~     controlling its safety and tolerability. By combining various rTMS protocols with a~     twelve-month follow-up, and using an effect modeling, the study aims at: (i) specify the~     effective values of rTMS parameters, with an adequate tolerance; (ii) determine the expected~     benefit and the persistence of effect; (iii) assess the practical feasibility of this kind of~     therapeutic management.~   "
164914|NCT01407120|"~     The project is a 15-year follow-up of 240 young adults whose families participated in an~     experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for~     divorced families. The NBP was provided in late childhood; the follow-up occurred in young~     adulthood. Families were randomly assigned to one of three conditions: mother program (MP),~     dual-component mother and child program (MPCP), or literature-control (LC) condition.~     Programs were designed to change several putative mediators of children's post-divorce mental~     health problems using empirically-supported change strategies. The investigators expected~     that the NBP would have either main or risk by program interactive effects on mental health~     and substance use problems and disorders, developmental tasks, parent-young adult~     relationships, physical health problems, and competencies, such that YAs who participated in~     NBP will have better functioning than YAs in the control condition. The investigators~     expected that the NBP will have either main or risk by program interactive effects on~     mothers' mental health; those in the NBP are expected to have fewer mental health problems~     than those in the control condition.~   "
164915|NCT01407107|"~     The purpose of this study is to determine whether topical nitroglycerin in addition to~     5-flourouracil and radiation therapy are effective in the treatment of operable rectal~     cancer.~   "
164916|NCT01407094|"~     This study will examine multiple carefully selected clinical and biological markers, using~     both existing state-of-the-art technologies as well as pioneering, innovative approaches. The~     study is designed to identify moderators and mediators of treatment response for depression~     in order to specify a biosignature of treatment response for depression. Evaluation of the~     usefulness of these markers in a carefully conducted clinical trial comparing an~     antidepressant to placebo will assist in developing a Depression Treatment Response Index~     (DTRI) to help clinicians match treatments to patients with MDD, resulting in timely~     selection of treatments best suited for individual patients and thus approaching personalized~     treatment. The resulting index provides a truly novel means of synthesizing the contribution~     of key clinical and biological parameters in an easy to use tool for clinical care.~   "
164917|NCT01407081|"~     The purpose of this study is to provide evidence for the feasibility and initial~     effectiveness of a manualized, telephone-based (telehealth) approach to the delivery of~     cognitive interventions (SMARTease) targeted to improve cognitive performance in daily~     activities after stroke.~   "
164918|NCT01407068|"~     The objectives of this study are to assess the safety and efficacy of concurrent~     administration of two injections of AA4500 into the same hand of subjects with multiple~     Dupuytren's contractures caused by palpable cords.~   "
164919|NCT01407055|"~     The purpose of this study is to evaluate the potential benefit of targeting patients'~     expectations before coronary artery bypass graft surgery through a brief psychoeducational~     intervention.~   "
164920|NCT01407042|"~     Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from~     unicompartmental knee osteoarthritis. Two different types of UKA design are available - both~     with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an~     additional amount of cartilage and bone close to the implantat. It is unclear whether this is~     of clinical relevance.~      We speculate that the amount of cartilage/bone removal is related to the clinical outcome of~     the UKA-surgery.~      In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured~     during the surgery. The clinical success of the procedure will be determined with certain~     knee questionnaires (Kujala & KOOS)preoperatively, 3 months postoperatively, 6 months~     postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling~     around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.~      The three variables (removed amount of cartilage/bone; clinical success with regard to the~     questionnaires; bone remodelling) are then analyzed with statistical methods to find out~     potential assoziations among them.~   "
164921|NCT01407029|"~     This is a prospective, non-randomized, consecutive series, multicenter clinical study that~     will include patients who will have total hip replacement with the R3 Acetabular System.~   "
164922|NCT01407016|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     metronidazole following single and multiple intravenous infusion in healthy Japanese adult~     subjects.~   "
164923|NCT01407003|"~     This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy~     subjects and in patients with T2DM.~   "
164924|NCT01406990|"~     The purpose of this study is to measure the percentage of women with known Coronary Artery~     Disease (CAD) who are hyporesponsive to low dose (81 mg) aspirin.~   "
164925|NCT01406977|"~     The purpose of the study is to determine tolerability, PK/PD and preliminary efficacy of~     BPS804 in adult patients with HPP treated with multiple escalating doses of BPS804.~      This study will allow a comparison of several doses of the study drug within the first two~     weeks after administration and after a longer assessment period for the highest dose level to~     enable selection of dose ranges to be tested in subsequent studies in the HPP indication.~   "
164930|NCT01406912|"~     A multicentre, randomized, two parallel group study comparing virtual reality using Wii~     gaming technology versus Recreational activities in patients receiving conventional~     rehabilitation after an ischemic stroke.~      Primary Hypothesis: Virtual reality using the Wii gaming system is more efficacious in~     improving motor function than recreational therapy among patients receiving conventional~     rehabilitation following a recent ischemic stroke.~   "
164931|NCT01406899|"~     In this behavioral trial 80 substance abusing individuals will be randomly assigned to either~     treatment as usual in the substance abuse clinic of the Newington, CT VA hospital OR~     treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period~     of 8 weeks. Primary outcomes will be retention in treatment and reduction in substance use~     (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to~     demonstrate coping skills through a computerized role-play evaluation will be a secondary~     outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.~   "
164932|NCT01406886|"~     This study will examine the independent and combined effects of energy density and eating~     rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy~     intake are expected to additively increase energy intake.~   "
164933|NCT01406873|"~     The purpose of this study is to investigate the effects of mexiletine treatment for 6 months~     on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning,~     cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).~   "
164934|NCT01406860|"~     The purpose of this study is to determine if droperidol is equally as effective as~     metoclopramide for treatment of primary headaches in the Emergency Department.~   "
164935|NCT01406847|"~     Body-based interventions have consistently shown clinical effectiveness in patients with back~     pain. The primary objective for this study is to compare the effect of body-based~     interventions commonly used in the management of low back pain on behavioral and cortical~     measures of pain sensitivity and central sensitization of pain. Participants will be randomly~     assigned to receive one of the interventions or be in a control group. The central hypothesis~     for this proposal is that spinal manipulation, a specific form of body-based intervention,~     inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other~     interventions. The completion of the proposed study will elucidate underpinning mechanisms of~     body-based interventions. Identification of these mechanisms will improve the clinical~     application and utilization of these interventions in the management of musculoskeletal pain~     conditions, especially back pain.~   "
164936|NCT01406834|"~     The goal of this project is to test the feasibility, acceptability, and efficacy of a~     treatment module addressing the mental health and functional impact of killing in the war~     zone.~      The investigators will enroll between 12-20 Veterans who have killed in war and have been~     diagnosed with post-traumatic stress disorder (PTSD) for a pilot study assessing the efficacy~     of the six-session treatment. Veterans will be randomized either to the treatment or to the~     waitlist control group.~   "
164937|NCT01406821|"~     Platelet rich plasma has been used in previous studies to stimulate faster healing of torn~     ligaments and tendons in order to help reduce pain and restore normal function. This study~     aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries~     with platelet rich plasma will reduce the time needed for participants to heal these injuries~     and restore function.~      We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.~   "
164938|NCT01406808|"~     The purpose of this study is to see if providing information to a person on their inherited~     (genetic) risk of cardiovascular disease (CVD) helps to motivate that person to change their~     diet, lifestyle or medication regimen to alter their risk.~   "
164939|NCT01406795|"~     To study the safety and efficacy of drug coated stents for the treatment of venous occlusions~     and stenoses in the lower extremity. The use of the device for the treatment of peripheral~     arterial disease is approved by the FDA, however, the use of the device in venous occlusions~     and stenoses, although performed by some practitioners, has not yet been studied in detail.~   "
164940|NCT01406782|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is studying DNA isolated from blood samples to see how well it~     influences response to rituximab in patients with follicular lymphoma treated on clinical~     trial ECOG-E4402.~   "
164941|NCT01406769|"~     This phase II trial studies bioimpedance spectroscopy in detecting lower-extremity lymphedema~     in patients with stage I, stage II, stage III, or stage IV vulvar cancer undergoing surgery~     and lymphadenectomy. Diagnostic procedures, such as bioimpedance spectroscopy, may help~     doctors to predict the onset of lower-extremity lymphedema in patients with vulvar cancer~     undergoing surgery.~   "
164942|NCT01406743|"~     The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or~     radiography, determining the lumbar pain cause and gravity, to propose a conservative~     treatment in first intention or a adapted spine surgery in first or second intention~     (Fritzell and al ., on 2001).~      The analysis and the correction of postural disorders pass inevitably by a good knowledge of~     the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS~     ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring.~      However, the EOS technology ™ is recent and few data were acquired with this technology for~     healthy population.~      So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the~     standing skeleton in position (to an asymptomatic adult population), by displaying the~     gravity constraints on the joints, and the compensation phenomena in normal situation. This~     functional information for a given age bracket would allow to propose to the patients with~     lumbar pain, adapted interventions to the gravity constraints considering the skeleton~     evolution for age bracket.~   "
164943|NCT01406730|"~     The purpose of the study is to determine the effect of 16 weeks of running exercise on~     various parameters related to heart, vascular systems, blood, and muscle in untrained males~     30-50 years old.~      Further, the investigators assess which of the above mentioned parameters may explain the~     increase of running performance most accurate.~   "
164944|NCT01406717|"~     SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in~     reducing blood glucose levels. The purpose of study is to establish safety and efficacy of~     SPIL1033~   "
164946|NCT01406691|"~     Delayed Sleep Phase Disorder (DSPD) is a sleep disruption that commonly occurs in teens and~     manifests as a difficulty in waking up in the morning, going to sleep early enough at night,~     and daytime disturbances such as depression, fatigue, and restlessness. The purpose of this~     study is to determine if brief flashes of light, that are scheduled to occur during sleep,~     are effective in treating DSPD.~   "
164947|NCT01406678|"~     Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces~     myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with~     cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study~     assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest.~     The study also addresses safety and clinical outcome.~   "
164948|NCT01406665|"~     Early detection of (pre)diabetes, including impaired glucose tolerance is currently deficient~     because the best accepted standard, an oral glucose tolerance test (oGTT), is not feasible in~     a setting of screening or broad case-finding and other current methods lack in sensitivity. A~     previously reported study, and analysis of retrospective skin autofluorescence (AF) data,~     suggests that noninvasive skin AF may offer an alternative for detection of (pre)diabetes.~     The objective is to test the validity of a decision tree based on skin autofluorescence, and~     some simple clinical characteristics, as a detection tool for diabetes and impaired glucose~     tolerance. Sensitivity and specificity, positive and negative predictive value of this skin~     AF based decision model will be compared to those of fasting plasma glucose (FPG), glycated~     haemoglobin (HbA1c), and to two short questionnaires (Finnish Findrisk, and Cambridge score).~      Study design: Skin AF, HbA1c and an oGTT (including an FPG) will be simultaneously performed~     in at least 120 persons with the characteristics described in the following paragraph. A~     Findrisk and Cambridge questionnaire will also be collected.~   "
164949|NCT01406652|"~     Th study investigates prospectively the cost-savings related to a one-stage bursectomy~     (debridement, drainage and closure at the same time) versus two-stage bursectomy~     (debridement, left open and closure at a second time) of severe bursitis among hospitalized~     patients for surgical treatment of septic bursitis.~      We suppose that the one-stage bursectomy reveals similar recurrence rates but is associated~     with a significant shortening of hospital stay, consumption of resources and increased~     patient satisfaction.~   "
164950|NCT01406639|"~     This study is for patients with recurrent epistaxis (nosebleeds) as a result of Hereditary~     Hemorrhagic Telangiectasia (HHT). The aim is to determine if ranibizumab, topically applied~     will diminish epistaxis in patients with HHT as measured by the HHT Epistaxis Severity Score~     (ESS), hematocrit, and hemoglobin and serum ferritin levels.~   "
164951|NCT01406626|"~     This study will implement a health navigation intervention to improve linkage to and~     retention in HIV care for inmates released from L.A. county jail into the community.~   "
164952|NCT01406613|"~     This is a 2year observational study that will recruit patients who have previously completed~     a randomised, open label, parallel, single centre study (TRIO Study) of three~     bisphosphonates: alendronate, ibandronate and risedronate. These drugs are the most commonly~     used group of treatments for postmenopausal osteoporosis in the UK. However, the length of~     time for which these treatments continue to work after they are stopped has not been fully~     elucidated. Without this information it is unclear as to how long doctors should treat and~     whether it would be good practice to give drug 'holidays'.~      The investigators plan to compare the effects on bone quantity and quality of stopping these~     licensed bisphosphonates in patients who have taken the medication for a duration of two~     years. The investigators aim to recruit up to 100 postmenopausal and up to 100 premenopausal~     (reference range) subjects. Measurements collected at the final visit of the previous study~     will be used for 'baseline' values for this study.~      The postmenopausal group will have an initial study visit to secure informed consent, and~     then further study visits at 24, 48, 72 and 96 weeks after stopping medication. Visit~     procedures will include:~      Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the~     spine, hip, whole body, forearm Dual-emission X-ray absorptiometry (DXA), and heel dual X-ray~     and Laser (DXL) Quantitative Ultrasound of Bone (QUS) Vertebral Fracture Assessment (VFA).~      The premenopausal group will have one study visit, 96 weeks after completing the previous~     study. Visit procedures will include:~      Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the spine~     and hip (DXA)~      A subgroup of 50 premenopausal women will also have the following measurements:~      Bone Mineral Density of the whole body, forearm (DXA), and heel (DXL) Quantitative Ultrasound~     of Bone (QUS).~   "
164953|NCT01406600|"~     Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from~     genetically engineered Chinese hamster ovary cells, which is widely used for final oocyte~     maturation triggering in assisted reproductive technology (ART).Recombinant hCG has been~     investigated about its safety and efficacy comparing with urinary hCG, but still the optimal~     dose of rhCG is questionable. From former studies, there only have been proven that high dose~     of hCG can make ovarian hyperstimulation syndrome (OHSS) in usual condition. On the other~     hand, we hypothesize that high dose of hCG may improve oocyte maturity in poor responders who~     cannot easily provoke OHSS. Hence, this study will assess the comparative efficacy and safety~     of 250mcg and 500mcg of rhCG in ART treatment cycle.~   "
164954|NCT01406587|"~     PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center,~     randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of~     symptoms associated with uncomplicated urinary tract infection. After the screening, patients~     are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and~     randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data~     about uncomplicated urinary tract infection symptoms are collected from the subjects on~     electronic handheld devices throughout the 48-hour study period. The primary endpoint is~     burning during urination.~   "
164955|NCT01406574|"~     The purpose of this study is:~      Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate~     the efficacy~   "
164956|NCT01406561|"~     The purpose of this study is to assess the effect of OMS103HP solution for Injection~     (OMS103HP-S) and function as measured by the Knee Osteoarthritis Outcome Survey (KOOS)~     Symptoms subscale through Day 30 compared with vehicle irrigation solution for knee symptoms~     in subjects undergoing meniscectomy.~   "
164957|NCT01406548|"~     This study is designed to provide information on the safety, tolerability, pharmacokinetics~     (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing~     regimens. This information will permit a comparison of the possible risks and benefits of~     different dosing regimens of the study drug to enable optimal doses and dose intervals to be~     tested in subsequent studies.~   "
164999|NCT01406002|"~     The primary objective of this study is to determine the effect of rifampicin on the way the~     body handles darexaban and its metabolites (drug degradation products). The secondary~     objective of the study is to evaluate the safety and tolerability of a single dose of~     darexaban alone and when administered together with rifampicin.~   "
164958|NCT01406535|"~     The aim of this study is to prospectively investigate if intermittent Phosphodiesterase 5~     inhibition for 15 weeks improves myocardial perfusion by angiogenesis in patients with~     therapy refractory myocardial ischemia due to coronary artery disease judged to be unsuitable~     for surgical or percutaneous revascularisation. For proof of efficacy the following tests~     will be performed at baseline and one day and 4 weeks after discontinuation of therapy:~     Exercise tolerance will be evaluated by bicycle exercise testing. Blood tests will be~     performed to evaluate markers of angiogenesis (endothelial progenitor cells, vascular~     endothelial growth factor, basic fibroblast growth factor). The improvement of myocardial~     perfusion will be tested functionally as increase of coronary flow reserve by positron~     emission tomography. Moreover, changes in ventricular function, symptoms and quality of life~     will be assessed.~   "
164959|NCT01406522|"~     No medications are currently available for treatment of psychostimulant addiction, a~     compulsive preoccupation with use of cocaine and related compounds. Tacrine, a medication~     that is currently prescribed for Alzheimer's disease, can decrease the amount of cocaine~     injections that laboratory animals choose to inject by vein. This project will determine if~     tacrine can also decrease cocaine-motivated behavior for human subjects in a laboratory~     setting.~   "
164960|NCT01406509|"~     Haemophilus influenzae is an important pathogen which can cause primary infection and~     respiratory viral infection in infants and leaded to secondary infections. The infection of~     haemophilus is a major cause of morbidity and mortality in infants and children. At present,~     the developed conjugant Hib vaccine is proved to be safe and effective, 90-99% of children~     will produce antibody of protection after 3 doses. Because Hib vaccine can prevent~     meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib~     bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune~     programming.~      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent~     years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus~     polysaccharide vaccine with a relatively poor immune response in the infants under the age of~     two, and the remaining 60% with a low antibody level and a short duration.~      According to the present immunization schedule, to reach the median level of antibody levels~     there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity,~     to provide high levels of long-term protection and to reduce the number of injections.~      The objective of this study is to evaluate the safety of the group A, C polysaccharide~     meningococcal and type b haemophilus Influenzal Conjugate vaccine.~   "
164961|NCT01406496|"~     Post-meal glucose excursions may contribute to the development of diabetes-related~     complications. These glucose excursions are affected by the food content of the meal and the~     timing of insulin injection (or insulin pump-bolus) before meal. The best timing for insulin~     bolus (by pump) is controversial.~      The aim of the study is to examine three different timings of insulin bolus in three types of~     breakfast meals that contain carbohydrates, carbohydrates + proteins and carbohydrate+ fat.~     The 3h post-meal glucose excursions will be recorded by continuous glucose monitoring system.~     The results obtained in the diabetic patients will be compared to those obtained in a group~     of healthy individuals that will consume similar meals.~   "
164962|NCT01406483|"~     The primary objective of this exploratory cohort study is to describe levels of platelet~     reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (CABG).~   "
164963|NCT01406470|"~     The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune~     Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.~   "
164964|NCT01406457|"~     The goal in this research is to develop better ways to detect and treat the damage caused by~     bleeding in the brain.~   "
164965|NCT01406444|"~     Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in~     bone density). A significant decrease in bone density is called osteopenia or osteoporosis.~     Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the~     bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this~     condition often have thin or weak bones that are more likely to break. They also have very~     low levels of a chemical called IGF-1 in their body. This chemical is very important for~     increasing bone growth in puberty and for maintaining healthy adult bones. The investigators~     would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can~     lead to an increase in bone formation, bone density, and bone strength in women with anorexia~     nervosa.~   "
164966|NCT01406431|"~     The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan~     co-administration and Livalo fixed combination drug in healthy male subjects.~   "
164967|NCT01406418|"~     The purpose of this study is to assess in healthy subjects the safety, tolerability,~     pharmacokinetics and immunogenicity of single escalating doses of CR6261, a monoclonal~     antibody against influenza A viruses.~   "
164968|NCT01406405|"~     Purpose The primary purpose of this study is to prospectively compare clinical and~     radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions~     and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.~   "
164969|NCT01406392|"~     The purpose of this study is to compare effectiveness and safety of a sublingual misoprostol~     12,5 mcg with vaginal misoprostol 25 mcg for induction of labour with an alive and term~     fetus.~   "
164970|NCT01406379|"~     Although endoscopic colonic polypectomy has been an established procedure for two decades,~     the risk of bleeding is still higher after resecting of pedunculated polyps, because of the~     presence of a large artery in the stalk. Several preventive methods such as detachable snare~     and adrenaline injection have been proposed in the management of postpolypectomy bleeding in~     large colonic polyps. For prophylactic clip, there was no prospective randomized study~     assessing the efficacy in the prevention of postpolypectomy bleeding for the large~     pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy~     of application of prophylactic clip and detachable snare in the prevention of postpolypectomy~     bleeding in large polyps. Application of prophylactic clip will be as effective and safe~     method as detachable snare in the prevention of postpolypectomy bleeding for the large~     pedunculated colonic polyps.~   "
165013|NCT01405820|"~     The primary objective of this study is to explore the effects of multiple regimens of~     natalizumab on disease activity and safety in participants with relapsing-remitting Multiple~     Sclerosis (RRMS).~   "
164971|NCT01406366|"~     Pediatricians serve an important role in promoting health in families. Bright Futures offers~     a child and family-centered approach to health promotion in incorporating partnership and~     communication skills of providers. Two areas of importance are in promotion of oral health~     and prevention of iron deficiency. We plan to study implementing educational curriculum to~     pediatric residents through a randomized controlled trial. Randomization will be done through~     assignment at the level of pediatric training program. Residents randomized to Group 1 will~     receive education about Bright Futures partnership and communication skills with oral health~     as the main health promotion topic. Group 2 will receive educational curriculum pertaining to~     the topic of iron deficiency prevention. While pediatricians are positioned perfectly to~     partner and effectively communicate with families on these two issues, there are gaps in~     pediatric education addressing these topics. The CORNET continuity practices of the~     Ambulatory Pediatric Association provide a venue through which multiple residency programs~     that educate pediatric residents and whose residents provide medical care to underserved~     children can participate. The research hypotheses include:~        1. Residents in Group 1 will have greater confidence, knowledge and competence in~          partnership building and communication with families~        2. Residents in Group 1 will have greater knowledge and competence in discussing oral~          health promotion~        3. Residents in Group 2 will have greater knowledge and competence in discussing iron~          deficiency prevention~        4. Parent-child dyads in Group 1 will be more likely to have established a dental home~        5. Parent-child dyads in Group 1 will be more likely to be satisfied with their healthcare~          encounter.~      Pediatric practices provide fertile ground for the provision of health promotion on oral~     health and iron deficiency prevention. However, evidence for the effectiveness of primary~     care clinician interventions of screening, referral and counseling to prevent dental caries~     is lacking [14]. The National Survey of America's Families [15] found 47% of children did not~     receive the recommended number of dental visits, with the youngest ones being least likely to~     receive any dental care.~      Although 90% of pediatricians agreed they had important roles in identifying and counseling~     patients on prevention of caries, half stated they had received no previous training during~     medical school or residency and their knowledge of basic oral health topics was limited [13].~     These studies highlight that pediatricians play important roles in oral health and are~     capable of being trained to complete oral screening exams, but more education and guidance is~     needed.~      Iron deficiency is the most common childhood nutritional deficiency in the United States.~     Recent prevalence data have determined that 7-30% of children in the United States aged 1-2~     years have iron deficiency and 3-10% have iron deficiency anemia [17, 18]. Specific goals in~     Health People 2010 include a reduction of iron deficiency to 5% in children less than 3 years~     of age.~   "
164972|NCT01406353|"~     Although percutaneous mitral commissurotomy (PMC) has been accepted as an effective treatment~     for symptomatic patients with moderate or severe mitral stenosis (MS), most asymptomatic~     patients are not candidates for PMC owing to the small but inherent procedure-related risks.~     Asymptomatic patients with MS show good survival rates up to 10 years, but there was a sudden~     deterioration precipitated by atrial fibrillation or embolism in half of the patients.~     Because the success rates of PMC were improved to more than 95% in ideal patients from highly~     selected centers and early PMC may decrease the occurrence of adverse events, such as atrial~     fibrillation or embolism, experienced centers tend to perform PMC at an early stage of~     disease. However, the potential benefits of early preemptive PMC in asymptomatic patients~     should be balanced against the real risks related to the procedure, and further studies of~     the efficacy of PMC in the prevention of embolism are necessary to extend its indications to~     asymptomatic patients. To the best of our knowledge, No randomized trials have been performed~     to ascertain the optimal timing of intervention in asymptomatic patients with significant MS.~     The early percutaneous MITral Intervention versus conventional manaGement in Asymptomatic~     moderate miTral stEnosis (MITIGATE) trial was designed to compare clinical outcomes of early~     intervention with those of a conventional management based on current guidelines in~     asymptomatic moderate mitral stenosis.~   "
164973|NCT01406340|"~     This will be an open-label, parallel-group study to evaluate the pharmacokinetics of~     GSK1278863 and metabolites in normal subjects and subjects with impaired renal function,~     including those who are hemodialysis dependent. GSK1278863 will be administered once daily~     for 14 days to normal subjects and subjects with Stage 3 and Stage 4 renal function, and 15~     days to subjects with Stage 5 renal function. Pharmacokinetic assessments will be made on~     Days 1 and 14 (normal subjects, subjects with Stage 3 and Stage 4 renal function) or Days 14~     and 15 (dialysis and non-dialysis days; Stage 5).~   "
164974|NCT01406327|"~     The objective of this post-marketing surveillance study is to evaluate the incidence of~     adverse events in Japanese subjects with pulmonary arterial hypertension treated with~     ambrisentan basd on prescribing information under the conditions of general clinical practice~     and also to grasp the following items;~        1. Unknown adverse drug reactions (ADRs)~        2. Incidence of ADRs to medical products in actual clinical practice~        3. Factors influencing safety of ambrisentan~        4. Factors influencing efficacy of ambrisentan~        5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use~          (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)~   "
164975|NCT01406314|"~     This study aims to provide safety information on the ligand, GSK2315698A. The~     pharmacokinetics and pharmacodynamics of the ligand will be determined together with the~     differences in routes of dose administration, namely the tolerability between intravenous~     versus subcutaneous dose administration. The study will be carried out in patients with~     systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid~     protein (SAP) will be measured.~   "
164976|NCT01406301|"~     Fondaparinux, a synthetic and specific factor Xa inhibitor, was granted an ACS indication by~     Health Canada in March 2007 and by the EMEA in September 2007. Among ACS patients,~     fondaparinux is indicated for the treatment of UA/NSTEMI in patients for whom urgent PCI~     (within 2 hours) is not indicated, and for the treatment of STEMI in patients who are managed~     with thrombolytics or who are initially to receive no other form of reperfusion therapy. The~     approved prescribing information for fondaparinux in ACS provides recommendations for use in~     patients undergoing PCI. The purpose of this study is to evaluate physician adherence to this~     prescribing information in ACS patients treated with fondaparinux and who undergo PCI. The~     primary endpoint is the proportion of patients with ACS treated with fondaparinux, for whom~     the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy~     administered at the time of PCI). Measurement of the effectiveness or safety of fondaparinux~     use in ACS patients is not within the scope of this study.~      ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.~   "
164977|NCT01406288|"~     The Hemolytic Uremic Syndrome (HUS) in its typical form occurs after a food born infection~     with a shiga-toxin secreting bacteria, usually Escherichia coli of the O157H7 serotype. An~     outbreak of bloody diarrhea followed by HUS begun after a collective meal with 120 persons on~     June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).~      At least 9 patients, 8 adults and 1 child have been involved in this HUS outbreak, E. coli of~     the O104:H4 serotype being demonstrated in most patients. This outbreak is remarkable by its~     preponderance in adults and women, its aggressiveness with multiorgan involvement , i.e. the~     kidneys, brain, liver, pancreas, and skin.~      Pathophysiology, prognosis, and treatment of typical HUS are poorly defined, particularly in~     adults who are usually not involved in typical E. coli O157H7 HUS.~      The aim of the present study is to gain knowledge on these different aspects of the HUS,~     including response to therapy.~   "
164978|NCT01406275|"~     This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the~     information on proper use, such as safety and efficacy, under actual use conditions,~     targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin~     infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis,~     tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media.~      (CLAVAMOX is a trademark of the GlaxoSmithKline group of companies.)~   "
164979|NCT01406262|"~     This study is designed to investigate the effect of treatment with albiglutide on the cardiac~     repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a~     positive control, or moxifloxacin placebo will be given in order to validate the ability of~     the study to detect a change in the corrected QT interval.~   "
164980|NCT01406249|"~     The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line~     treatment of Advanced Gastric Cancer.~   "
164981|NCT01406236|"~     The hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI,~     transradial PCI will result in a significant reduction in bleeding and vascular~     complications. The primary objective is to compare the efficacy and feasibility of the~     transradial approach to percutaneous coronary intervention (PCI) in women compared with the~     transfemoral approach.~      This study is a multicenter, randomized, open-label active controlled study. Three thousand~     women undergoing urgent or elective PCI from at least 50 centers will be randomized to either~     transradial or transfemoral PCI. Patients who are enrolled at sites performing ad hoc PCI~     will be randomized before diagnostic angiography. A total of approximately 3000 women will be~     randomized to obtain a cohort of approximately 1800 patients undergoing PCI.~      The Data Safety Monitoring Board has alerted us that the bleeding event rate overall in our~     trial is very low, making it unlikely that there will be statistical power to show a~     difference between the randomized arms in the SAFE PCI for Women study using the BARC~     bleeding definition per protocol. Based on this statistical futility, the DSMB has~     recommended stopping enrollment. They also noted, however, that as this is not based on any~     safety issues, and since there are a variety of key secondary endpoints (contrast and~     radiation exposure, quality of life) that are of clinical and scientific interest, the DSMB~     left it to the discretion of the Steering Committee to continue enrollment to meet sufficient~     power for these outcomes. On March 1, 2013, the Steering Committee met to discuss these~     issues and voted to continue enrollment until the planned sample size for the Quality of Life~     substudy was met (300 patients).~   "
164982|NCT01406223|"~     The purpose of this study is to look at brain function in order to understand how different~     treatments work to help people quit smoking. In this study, the investigators will look at~     the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.~   "
164983|NCT01406210|"~     The purpose of the prospective study is to collect information surrounding lung transplant in~     order to develop a randomized study to determine if prevention of gastroesophageal reflux~     disease (GERD) related aspiration (stomach acid coming up from the stomach into the~     esophagus) by surgical fundoplication improves lung rejection. Lung transplantation has~     evolved into an effective treatment for patients with end-stage lung disease; however, a~     significant limitation to long-term survival is patients develop a condition of scarring~     known as chronic lung rejection, which can cause lung function to deteriorate, thereby~     reducing a patient's chances for survival. Preliminary research has shown a correlation~     between the presence of gastroesophageal reflux disease (GERD) and impaired early lung~     rejection as assessed by a breathing test, FEV1 (the amount of forced expired air volume in 1~     second).~      The Investigator is interested in learning more about this condition and the potential for~     aspiration (inhaling fluid) injury. The primary goal of this preliminary study will be to~     identify aspiration markers that are correlated with adverse clinical outcomes (increased~     early rejection, decreased FEV1) that may be used as inclusion criteria for the future~     randomized trial.~      The purpose of the retrospective study is to collect information surrounding lung transplant~     in order to develop a randomized study to determine if prevention of gastroesophageal reflux~     disease (GERD) related aspiration (stomach acid coming up from the stomach into the~     esophagus) by surgical fundoplication improves lung rejection.~      The goal of this retrospective data collection is to review the following:~        1. subject outcome event rates for subjects with and without gastroesophageal reflux~          disease (GERD) for survival, Bronchiolitis Obliterans Syndrome (BOS), acute rejection~          and Forced Expiratory Volume in the first second (FEV-1),~        2. the estimated treatment effect of fundoplication on the above event rates,~        3. a threshold effect for Bronchiolitis Obliterans Syndrome (BOS) and/or death are more~          likely to occur at higher or more proximal acid or non-acid contact times.~      This data will be collected in order to better design and coordinate a multicenter~     prospective study.~   "
164984|NCT01406197|"~     This study will examine the effects of various formulations of progesterone on uterine~     electromyographic (EMG) activity in pregnant patients in premature labor to determine if~     progesterone will suppress uterine electrical activity and which formulation may be best for~     inhibition of uterine activity. Patients will be monitored prior to treatment and following~     treatment (every 2 to 4 hours) with one of three different formulations of progesterone for~     up to two days. Patients will continue to be observed until they deliver. Comparisons will be~     for uterine EMG activity from before treatment to that following treatments at 2, 4, 8, 12 24~     and 48 hours and times of delivery after treatments (hours or days following treatments).~     Comparisons between mean values for EMG activity between the various treatments at the~     various times will also be made.~   "
164985|NCT01406184|"~     The aim of this randomized controlled trial (RCT) is to evaluate the impact and mechanisms of~     the Durham Connects (DC) brief universal nurse home-visiting program to prevent child~     maltreatment and improve child well-being. It is the first-ever RCT of a home-visiting~     program that is designed to prevent child maltreatment in an entire community population.~      Evaluation of program impact will test three hypotheses: 1) Random assignment to the Durham~     Connects Program will be associated with lower rates of child maltreatment and emergency~     department maltreatment-related injuries, better pediatric care, better parental functioning,~     and better child well-being than assignment as control; 2) Intervention effect sizes will be~     larger for higher-risk groups; and 3) Community resource use and enhanced family functioning~     will mediate the positive impact of Durham Connects on outcomes.~   "
164986|NCT01406171|"~     The purpose of this study is to determine the effect of isavuconazole at steady state on the~     pharmacokinetics of midazolam in healthy adult subjects.~   "
164987|NCT01406158|"~     A study in healthy volunteers comparing two different liquid formulations of solifenacin with~     each other and with the tablet formulation.~   "
164988|NCT01406145|"~     This study is intended to determine the safety and tolerability of ASP0777 in subjects with~     Alzheimer's Disease (AD) taking a stable dose of donepezil.~   "
164989|NCT01406132|"~     The objective of this study is to evaluate pharmacokinetics, in particular the routes of~     excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled~     ASP015K.~   "
164990|NCT01406119|"~     This is an extension study of ABT-806 for subjects with advanced solid tumors.~   "
166021|NCT01392664|"~     Women who had urinary stress incontinence and underwent one of two procedures: the classic~     TVTO or the Folke-Flam method of surgical operation, will be evaluated and compared.~   "
164991|NCT01406106|"~     Background information Studies have been conducted on supplementing the daily diet with plant~     sterol ester-enriched milk derivatives in order to reduce LDL-cholesterol levels and,~     consequently, cardiovascular risk. However, clinical practice guidelines on~     hypercholesterolaemia state that there is not sufficient evidence to recommend their use in~     subjects with hypercholesterolaemia. The null hypothesis establishes that there is no~     relationship between the decrease in blood LDL-cholesterol levels and the consumption of~     stanol ester enriched liquid yoghurt. The alternative hypothesis establishes a relationship~     between such consumption and the incidence of the primary variable.~      The main objective of this study is to determine the efficacy of the intake of 2 g of plant~     sterol esters a day in lowering LDL-cholesterol levels in patients diagnosed with~     hypercholesterolaemia. The specific objectives are: 1) to quantify the efficacy of the daily~     intake of plant sterol esters in lowering LDL-cholesterol, total cholesterol and~     cardiovascular risk in patients with hypercholesterolaemia; 2) to evaluate the occurrence of~     adverse effects of the daily intake of plant sterol esters; 3) to identify the factors that~     determine a greater reduction in lipid levels in subjects receiving plant sterol ester~     supplements.~      Study design Randomised, double-blind, placebo controlled experimental trial carried out at~     family doctors' surgeries at three health centres in the Health Area of Albacete (Spain). The~     study subjects will be adults diagnosed with limit or defined hypercholesterolaemia and~     who have LDL cholesterol levels of 130 mg/dl or over. A dairy product in the form of liquid~     yoghurt containing 2 g of plant sterol ester per container will be administered daily after~     the main meal, for a period of 24 months. The control group will receive a daily unit of~     yogurt not supplemented with plant sterol esters that has a similar appearance to the~     enriched yoghurt. The primary variable is the change in lipid profile at 1, 3, 6, 12, 18 and~     24 months. The secondary variables are: change in cardiovascular risk, adherence to the dairy~     product, adverse effects, adherence to dietary recommendations, frequency of food~     consumption, basic physical examination data, health problems, lipid-lowering medication,~     physical activity, smoking habits and socio-demographic variables.~   "
164992|NCT01406093|"~     A timing diagnosis of candidemia is as important as the correct choice of empiric or targeted~     antifungal therapy. In the last years a growing body of knowledge has better characterized~     health-care associated (HCA) infections, which have been described in 2002 in outpatients~     with MRSA bloodstream infections. So far there is no compelling evidence that patients with~     HCA infections may develop candidemia before the usual timing of around 20-25 days after~     admission. Risk factors associated with HCA infections are represented by admission from long~     term chronic care facilities (LTCF), haemodialysis, previous admission or parenteral broad~     spectrum antibiotics. There are few data HCA features and early onset candidemias in the~     published literature.~      In this proposal, the investigators aim at studying early-onset candidemia in a retrospective~     study in one of the largest referral hospital in Italy with a consistent range of specialties~     ranging (bone marrow transplant, solid organ transplant, immunosuppressed patients, ICU,~     complex surgery). The investigators speculate that patients with candidemia diagnosed within~     10 days (early-onset) by the admission have different risk factors and prognosis of those~     with a late diagnosis.~   "
164993|NCT01406080|"~     The purpose of this study is to:~        1. Evaluate the efficacy of Adapalene gel 0.3% compared to Tretinoin Emollient cream 0.05%,~          reducing signs of cutaneous photoageing, measured trough photonumeric scale evaluation,~          investigator evaluation of global response to treatment and subject's evaluation of~          improvement.~        2. Evaluate the safety and tolerability of Adapalene Gel 0.3%, compared to Tretinoin~          Emollient cream 0.05% during 24 weeks of treatment.~      The study has the clinical hypothesis that Adapalene Gel 0.3% is as effective as Tretinoin~     Emollient cream 0.05% in the treatment of cutaneous photoaging.~   "
164994|NCT01406067|"~     The efficacy of the Treatment Program for Children with Aggressive Behaviour~     (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) which is a social competence~     training delivered in an individual format will be evaluated in a randomized controlled trial~     with children aged 6 to 12 years with peer-related aggressive behaviour.~   "
164995|NCT01406054|"~     Sports-related injuries are a serious concern for physically active children and adolescents.~     Previous research, including ours at Chicago public high schools, shows our neuromuscular~     training program, the Knee Injury Prevention Program (KIPP) reduces sports-related injuries~     in female athletes by up to 88%. However, KIPP is not well-studied in males or younger age~     groups. This project aims to determine KIPP's effect on sports-related injuries and physical~     fitness among 5th-8th grade students in Chicago public schools. The study will take place~     during the 2011-2013 school years. To measure KIPP's effect on sports injuries, we will~     recruit 5th-8th grade sports coaches and their athletes, randomize coaches by school into two~     groups, then train the intervention group to implement a 10-minute KIPP warm-up before~     practices and games. Control group will perform their usual warm-up. Research assistants will~     collect athlete participation and injury data from coaches weekly. To determine feasibility~     of KIPP in PE classes and measure its effect on fitness, we will recruit PE teachers to~     implement the warm-up in PE classes for a minimum of 10 weeks, and record students'~     presidential fitness test scores before and after the 10+ weeks. Results of this study will~     guide strategies for preventing sports-related injuries and improving physical fitness in 5th~     -8th graders.~   "
164996|NCT01406041|"~     The fluid and electrolyte imbalance (FEI) is pretty common encountered during the clinical~     process of patients suffered sellar lesions. Moreover, if the patients are undergone the~     surgery for remove the lesion, FEI happens in all cases without exception. Hypo- and~     hyper-natremia is the most common electrolyte disorder, which is directly correlated to the~     patients' outcome. However, in clinical works, different sellar diseases cause variant~     features of FEI. For example, after the surgery of craniopharyngioma, the hyponatremia and~     hypernatremia always happen alternatively even without any precursor manifestation. Under~     this situation, it is quite difficult for fluid supplement. In contrast, the severe FEI will~     cause poor outcome, even death. So it is necessary to systematically collect and review the~     clinical data of sellar lesions. Through the analysis of variant FEI patterns of sellar~     diseases, more precise strategy for clinical fluid replacement will be proposed.~   "
164997|NCT01406028|"~     In vitro fertilization for infertility has been associated with a significant amount of~     treatment related stress for patients. In addition,stress levels increase between embryo~     transfer and pregnancy test, during this waiting period. The investigators evaluated whether~     or not brief interventions by phone by trained social workers influenced stress levels. Our~     data showed that these interventions did not change levels, but confirmed that stress did~     increase during this time and that patients report wanting additional emotional support to~     improve stress during this period.~   "
164998|NCT01406015|"~     The purpose of this study is to find out if spironolactone, a drug that blocks the action of~     aldosterone, can make the blood vessels work better in people with obesity. The investigators~     also want to find out whether spironolactone causes changes in levels of insulin and markers~     of inflammation.~   "
165252|NCT01402700|"~     The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming~     the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System~     for the treatment of stenotic, restenotic or occluded lesions in the common and external~     iliac artery.~   "
165001|NCT01405976|"~     Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus~     continuous positive airway pressure (CPAP) and life style modification treatment in Obesity~     Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second~     phase) analyzed as a primary variables and percentage of dropouts for medical reasons and~     mortality as operative variables. As secondary variables: Measure functional and clinical~     improvement during sleep and wakefulness, quality of life, echocardiography and the incidence~     and blood pressure and evolution of cardiovascular events. Objectives secondaries:role of~     apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of~     diurnal hypercapnia. Methods:prospective, randomized controlled trial. Patients with OHS will~     be divided initially into two groups based on their apnea-hypopnea index (AHI) score, >=30~     and < 30, using conventional polysomnography. The AHI >=30 group will be randomized to CPAP,~     NIV or life style modification treatments. The AHI <=30 groups will be randomized to NIV or~     life style modification treatments. Treatment efficacy at the medium- and long-term will be~     analyzed by comparing groups. The role of apneic events and leptin in the genesis of daytime~     alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient~     between responders and non-responders to CPAP treatment, and the evolution of leptin levels~     in the four branches of the study. The role of apneic events in metabolic and biochemical~     alterations and endothelial dysfunction will be analyzed by comparing basal and~     post-treatment levels of related substances between groups, with and without significant AHI.~   "
165002|NCT01405963|"~     The purpose of this study is to assess the late asthmatic response, safety and tolerability~     of AMG 157 following multiple intravenous (IV) dose administration in subjects with mild~     atopic asthma.~   "
165003|NCT01405950|"~     A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety~     and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in~     Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.~   "
165004|NCT01405937|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir~     given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin~     (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous~     therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage~     of participants achieving sustained virologic response 24 weeks after completion of all study~     therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is~     greater than 20% (historical data of standard of care treatment).~   "
165005|NCT01405924|"~     This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant~     (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3~     antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting~     (CIV) in participants who experienced CIV in the first cycle of moderately emetic~     chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching~     in at least 20% of participants during the second cycle of MEC in participants who previously~     experienced vomiting during the first cycle of MEC.~   "
165006|NCT01405911|"~     This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin~     (MK-0431/ONO-5435) used once daily (qd) for Japanese subjects with impaired glucose tolerance~     who have inadequate glycemic control using diet and exercise therapy.~   "
165007|NCT01405898|"~     We are interested in the effect of diet on blood pressure. Our previous research has shown~     that beetroot juice lowers blood pressure in healthy people. We now want to see if beetroot~     juice has this effect in people with high blood pressure. Beetroot juice is naturally rich in~     nitrate (also found in most other vegetables but particularly in green leafy vegetables). We~     think that it is the nitrate that lowers the blood pressure.~   "
165008|NCT01405885|"~     This is a Phase I, parallel design open label study to evaluate safety, tolerability and~     immunogenicity of nine different formulation of two individual H1 and one H5 HA plasmid~     administered intradermally followed by electroporation in healthy adults~   "
165009|NCT01405872|"~     The primary objective of the study is to determine physician reported persistence with the~     Avonex PEN at Month 12/End of Study as well as determining factors associated with~     persistence. The secondary objectives for this study are as follows: To evaluate the~     tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To~     evaluate patient quality of life (QoL) while using the Avonex PEN for treatment~     administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the~     Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection~     procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence~     at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate~     overall patient satisfaction with the use of the Avonex PEN for treatment administration at~     Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12;~     and To evaluate the percentage of patients switching from caregiver to self-injection at~     Months 3, 6, and 12.~   "
165010|NCT01405859|"~     Doctors provide a ray of hope to children and their parents with the knowledge that, for most~     patients, symptoms of Tourette syndrome improve by the time they are young adults. The~     investigators do not know why some improve and others do not. This study is designed to help~     answer that question. The investigators will use magnetic resonance imaging (MRI) techniques~     to test whether individuals who experience improvement of their Tourette's (tic remission)~     have more mature brain connections than those who do not.~   "
165011|NCT01405846|"~     We are going to use a special type of bronchoscopy test to examine patients who have had~     previous surgical treatment for lung cancer or head and neck cancer. The aim is to determine~     a) whether we can identify precancerous changes in their airways b) whether this type of~     testing is acceptable and c) get an initial idea of whether a new drug called gefitinib has~     any effect on precancerous areas in the airway.~   "
165012|NCT01405833|"~     The primary objective of the study is to evaluate the safety, tolerability, and~     pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed~     schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).~      Secondary objectives of this study in this study population are to explore the repeated-dose~     immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following~     multiple-dose administration.~   "
165014|NCT01405807|"~     Overview:~      This open label, randomized, multi-centre study will enroll and treat 24 patients with~     refractory AAV.~      Aims:~      To determine the clinical response and severe adverse event rates associated with alemtuzumab~     therapy among patients with relapsing or refractory ANCA associated vasculitis (AAV).~      Hypothesis:~      Treatment with alemtuzumab induces sustained remission in AAV and will reduce~     immunosuppressive and steroid exposure.~   "
165015|NCT01405794|"~     The investigators propose to study oral commercial silver nanoparticle products on human~     enzyme activity.~   "
165016|NCT01405781|"~     The objective of this study is twofold: First, to determine whether higher levels of~     pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff~     repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function,~     Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score), physically~     examine and perform a radiographic analysis of patients at a minimum of 6 months after~     reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic~     scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator~     cuff repair.~   "
165017|NCT01405768|"~     Women undergoing a LEEP procedure who receive lidocaine buffered with sodium bicarbonate for~     their cervical block will experience less injection pain than women who receive plain~     lidocaine.~   "
165018|NCT01405755|"~     Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight~     in young children. In Mexico, breastfeeding extends well into the second half of infancy, but~     animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo.~     This study evaluates whether knowledge and practices about dietary diversity and food~     consistency can be improved using a two-component intervention strategy in semi-urban~     communities in Mexico. The two components will deliver appropriate complementary feeding~     messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio~     messages and interviews. The intervention is evaluated using a cluster randomized design in~     small semi-urban communities in two states in Mexico with pre- and post-test questionnaires~     designed to assess changes in feeding behaviors.~   "
165019|NCT01405742|"~     The purpose of this pilot R34 trial is to determine the feasibility of a large single dose~     Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly~     recombinant factor VIII. Efficacy will measured by bleeding frequency, factor usage, joint~     range of motion, cost, quality-of-life, F.VIII level, and inter-dose hypocoagulability by~     thrombin generation. Safety will be measured by inhibitor formation and bleeding events~     unresponsive to up to two rescue doses.~   "
165020|NCT01405729|"~     The purpose of this retrospective study was to determine the accuracy of femoral tunnel~     placement utilizing Redfern et al's radiographic method for anatomic femoral attachment~     during MPFL reconstruction in addition to the resultant outcome.~   "
165021|NCT01405716|"~     The primary objective of this study is to determine the effectiveness of a mind-body program~     in increasing function and reducing pain among older adults with chronic low back pain~   "
165022|NCT01405703|"~     This is a prospective, level II evidence comparison between two cohorts. This study is~     designed to compare the percutaneous versus open approach for plate fixation of diaphyseal~     clavicle fractures. This study includes questionnaires and measurements that will collect~     data on incision-related numbness, union rates, overall outcomes, complication rates of the~     two methods, infection rates, and overall satisfaction. The surgical procedure, all~     radiographs and follow-up visits to a minimum of one year are the principle investigators~     (PI's) standard of care for this injury. Measurements and questionnaires are related to the~     study.~   "
165023|NCT01405690|"~     Computer tomography coronary angiogram (CTCA) has emerged as a noninvasive alternative to~     assessing coronary artery luminal disease. Although the use of noninvasive CTCA for the~     detection of coronary artery disease is on the rise, the current technology of the 64-row~     multidetector computer tomography (MDCT) is subjected to multiple patient artifacts that can~     affect image quality.To eliminate these patient related artifacts a more advanced 320-row~     MDCT was recently developed. The investigators therefore propose that the newly developed~     320-MDCT can provide an accurate noninvasive assessment of the severity of coronary artery~     luminal stenosis as an alternative to an invasive coronary angiogram.~   "
165024|NCT01405677|"~     The primary purpose of the original study was to assess whether the protection afforded by~     the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection~     afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a~     computer based modelling analysis of the long term protection afforded by the paediatric~     dose, and to compare this with the standard dose and also with an alternative hepatitis A~     vaccine (Havrix Junior).~   "
165025|NCT01405664|"~     The rationale for this research study is to evaluate the effect on clinical outcomes of~     weight bearing as tolerated after forage surgery for the treatment of osteochondral defects~     of the ankle, thus potentially eliminating the need for a period of immobilisation or~     non-weight bearing after surgery.~      The investigators hypothesize that their will be no difference in functional outcomes between~     weight bearing as tolerated as compared to non-weight bearing for six weeks after forage~     surgery for OCD of the ankle.~   "
165026|NCT01405651|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-6950~     across ascending multiple doses in healthy adult male and female subjects. The secondary~     objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by~     measuring plasma concentrations of ONO-6950 and pulmonary function.~   "
165027|NCT01405638|"~     Primary Aim: To evaluate the effect of a lifestyle intervention delivered through~     telephone-based motivational interviewing (MINT) versus a patient navigation intervention on~     blood pressure reduction and CRC screening.~      Hypotheses: Among black men, aged > 50 years with uncontrolled HTN and in need of CRC~     screening:~        1. Hyp. 1: those randomized to the lifestyle intervention will have lower BP compared to~          those randomized to the patient navigation intervention at 6 months.~        2. Hyp. 2: those randomized to the patient navigation intervention will have higher CRC~          screening rates compared to those randomized to the lifestyle intervention at 6 months.~   "
165283|NCT01402297|"~     The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen~     species) and NOS (reactive nitrogen species) synthesis in 13 COPD patients. Effects of~     nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (EBC) after~     30, 60 and 120 minutes.~   "
165028|NCT01405625|"~     Asthma has an especially great impact on poor urban children and their families. In addition~     to higher asthma prevalence and morbidity, those in low SES urban areas are at risk for low~     health literacy. Low health literacy is associated with poorer asthma outcomes. The provision~     of a written asthma action plan has been shown to help with asthma management and to reduce~     hospitalizations and ER visits. Poor urban families who may have low literacy may need an~     alternative asthma action plan to convey the treatment plan.~      This pilot study proposes to investigate whether a plain language asthma action plan can~     improve parent understanding and adherence with medication instructions, compared to standard~     written materials, among parents of children with asthma. This is an RCT in which parents of~     children with asthma will be randomized to either receive a pictogram-based low literacy~     asthma action plan, or a standard action plan (AAAAI), to examine whether those who receive~     the low literacy plan have improved asthma action plan knowledge when presented with a~     hypothetical scenario.~      A second part of the study is to examine whether providers who are given the pictogram-based~     low literacy asthma action plan will be more likely to counsel about certain aspects of~     asthma management (eg. need for daily medications even when sick, spacer use, confusion~     between everyday and rescue inhaler)compared to providers who receive use a standard action~     plan (AAAAI). This is an RCT in which pediatric providers are randomized to counsel a~     hypothetical patient using the pictogram-based action plan or the standard action plan~     (AAAAI).~   "
165029|NCT01405612|"~     An open-label, single centre, randomised, cross-over study to examine the effect of~     ulimorelin on the pharmacokinetics of midazolam after repeat dose administration of~     ulimorelin in healthy volunteers.~   "
165030|NCT01405599|"~     Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a~     single intravenous (IV) dose in order to identify potential patients at risks in terms of~     severity of hepatic dysfunction and to determine whether their dosage should be adjusted.~   "
165031|NCT01405586|"~     The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy~     with gemcitabine in elderly patients with non small cell lung cancer in terms of overall~     survival.~   "
165032|NCT01405573|"~     The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best~     supportive care with best supportive care alone in terms of survival in patients with~     hepatocellular carcinoma (HCC) with impaired liver function (Child B).~   "
165033|NCT01405560|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir~     (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and~     ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who~     have not responded to previous treatment. The primary efficacy objective is to estimate~     efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the percentage of~     participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV RNA) 24 weeks~     after completion of all study therapy (Sustained Viral Response 24 [SVR24]).~   "
165034|NCT01405547|"~     Childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in~     life. Recent evidence indicates that abnormalities that increase risk for diabetes may be~     initiated early in infancy. Since the offspring of women with diabetes have an increased~     long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic~     abnormalities on early nutrition and infant metabolic trajectories is of considerable~     interest. The purpose of the study is to investigate the impact of maternal nutrition and~     metabolic abnormalities in pregnancy on human milk and subsequently on infant health over the~     first year of life.~   "
165035|NCT01405534|"~     It is an observational, prospective, monocentric study. The purpose of the study is to assess~     the acute complications rate caused by a central venous catheter placement.~      All the patients who require a central venous placement could be enrolled in the study.~      The study will not change the usual practice. The placement will be on day 1 and patients~     will be contacted by phone on day 7 to identify potential complications and to assess pain.~      Anaesthesia staff will keep patients under surveillance to control the absence of late~     complications.~   "
165036|NCT01405521|"~     Using an established model of human typhoid infection, whereby healthy adults are~     deliberately infected with typhoid-causing bacteria, the investigators will determine how~     effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously~     licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used~     works properly.~   "
165037|NCT01405508|"~     This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety~     and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with~     epilepsy according to an initiation or a conversion scheme, during repeated dosing (100~     mg/administration twice daily for 4.5 days).~   "
165038|NCT01405495|"~     The goal of this study is to identify the early modifications in fronto-temporal connectivity~     in female victims who developed PTSD, compared to female victims who did not develop the~     disorder, and to healthy control females. The investigators will compare between all these~     groups, structural and functional differences using different techniques (MRI, fMRI, DTI and~     ASL), and paradigms (cognitive tasks or at rest).~   "
165039|NCT01405482|"~     Botulinum toxin type A injected into the anterior and middle scalene muscles will reduce the~     irritation on the neurovascular structures at the interscalene triangle in subjects with TOS.~     This will lead to reductions in pain and paresthesias, and improvements in function when~     compared with injection of placebo.~   "
165040|NCT01405469|"~     This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic~     myotomy for the treatment of achalasia in a single center setting in Europe.~   "
165070|NCT01405079|"~     Activating somatic mutations of the tyrosine kinase domain of epidermal growth factor~     receptor (EGFR) have been characterized in a subset of patients with advanced NSCLC.The EGFR~     mutation rate was 30% in Chinese Non-small Cell Lung Cancer(NSCLC). Patients harboring these~     mutations in their tumors show excellent response to EGFR tyrosine kinase inhibitors~     (EGFR-TKIs). This randomized phase III trial is studying gefitinib to see how well it works~     compared to cisplatin-based chemotherapy in treating patients who have undergone surgery for~     stage II-IIIA(N1-N2) NSCLC with EGFR activating mutation in Asian population.~   "
165301|NCT01402063|"~     To obtain preliminary data in a randomized phase II study whether PPX/RT improves~     progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT~     methylation.~   "
165041|NCT01405456|"~     The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle~     modification to affect sugar metabolism, body fat distribution, and cardiovascular health in~     HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that~     aldosterone, a hormone that regulates salt and water balance, is increased in association~     with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals,~     aldosterone appears to be higher in individuals with increased belly fat, and increased~     aldosterone appears to be strongly associated with impaired sugar metabolism. In this study,~     the investigators will test the effects of eplerenone, which is a medication that blocks the~     actions of aldosterone, along with lifestyle modification. The investigators hypothesize that~     eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce~     fat accumulation in liver and muscle.~   "
165042|NCT01405443|"~     This is a randomized controlled trial evaluating three training intervals using an endoscopy~     simulator for novices and comparing performance after training.~   "
165043|NCT01405430|"~     It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess~     the predictive value of VE-cadherin on the objective tumor response.~      Biological factors will be correlated to clinical outcome measures.~      100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be~     enrolled.~      Patients will be followed every 10 weeks until progression in spite of bevacizumab or until~     they stop bevacizumab because of toxicity.~      Bevacizumab will be administered according to investigators appreciation.~      Blood samples will be collected at enrollment, at second bevacizumab's administration and~     every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or~     until one year at most in case that patients still receive bevacizumab.~   "
165044|NCT01405417|"~     This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic~     myotomy for the treatment of achalasia in a multi center setting.~   "
165045|NCT01405404|"~     The purposes of this study are to (1) study the cost-effectiveness of childcare discounts on~     increasing parent participation rates in a preventive parent training program called the~     Chicago Parent Program and (2) evaluate the efficacy of the Spanish-translated version of the~     Chicago Parent Program in childcare centers serving low-income families with young children.~   "
165046|NCT01405391|"~     Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose~     (RD) of PM01183.~   "
165047|NCT01405378|"~     Every five minutes someone in the UK has a stroke. It is the main cause of long-term~     disability among adults in the UK despite a fall in age-specific stroke incidence, with a~     growing number of survivors remaining dependent for activities of daily living. While most~     people with stroke regain walking ability, upper limb problems with no voluntary arm and hand~     activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct~     current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through~     the application of weak direct currents and has the potential to develop into a useful aid to~     treatment strategies in neurorehabilitation. Recent literature into the application of tDCS~     in people with arm and hand impairments after stroke has shown promising results on upper~     limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot~     study evaluated a six-week training programme combining tDCS with robot-assisted hand~     training and reported significant improvements in upper limb function. However, the robot in~     the latter study focused on single-plane distal movements only and long-term effects of the~     tDCS were not assessed. Recent robotic developments included robots with three rotational~     degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined~     with tDCS in early stroke settings is unknown. Ethical Approval was sought from NHS NRES~     Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.~   "
165048|NCT01405365|"~     The purpose of this study is to investigate the effect that obesity may have on the~     nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive~     periodontal diseases (chronic periodontitis).~   "
165049|NCT01405352|"~     In this double blind placebo controlled trial,cytokine secretion of CD4+ T-cells after 4~     month supplementation of vitamin A will be compared with placebo intaking group.~   "
165050|NCT01405339|"~     Budesonide, a steroid subtype, has been used as an adjunctive treatment for chronic~     rhinosinusitis as a topical nasal steroid spray. The current standard of care at St. Paul's~     Sinus Centre is to administer budesonide via the Mucosal Atomization Device (MAD). It is~     believed that the MAD is a better device than the standard nasal lavage because its fine mist~     enhances absorption and improves bioavailability. No studies have been done to determine if~     enhanced absorption and improved bioavailability of budesonide via MAD could potentially~     affect the hypothalamic-pituitary-adrenal (HPA) axis, resulting in the suppression of our own~     body's production of natural steroids.~   "
165051|NCT01405326|"~     The purpose of the study is to assess whether a 6-month treatment with adalimumab added on~     the treatment with conventional antirheumatic drugs (DMARD) will decrease the number of days~     on sick leave compared to placebo. In addition, the cost-effectiveness and cost-utility of~     the intervention compared to the conventional treatment is evaluated, and the patients who~     benefit most are characterized.~   "
165052|NCT01405313|"~     This study will determine if modified adaptive servoventilation (ASV) is as effective as the~     conventional ASV in treating periodic breathing. The study will determine if the modified ASV~     reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive~     airway pressure compared to conventional ASV.~   "
165053|NCT01405300|"~     Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and~     insulin response when incorporated into an acute high fat/high glucose meal. However, it is~     unclear whether acute consumption of peanuts can also influence vascular function. This study~     will therefore evaluate the effects of acute peanut consumption on vascular function,~     glycemic control, and plasma lipids. The hypothesis is that that addition of peanuts to a~     high fat/high glucose meal will reduce the production of triglycerides, glucose, and improve~     endothelial function as measured by flow-mediated dilation (FMD).~   "
165110|NCT01404559|"~     Many service members suffering major limb amputation(s) during active duty seek to return to~     active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic~     differences exist between popular multi-function prosthetic feet that would facilitate return~     to duty for soldiers with amputations.~   "
165054|NCT01405287|"~     OBJECTIVE It is the objective of the REMEDEE OCT study to assess vascular healing after~     deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered~     Sirolimus Eluting Stent) in patients with Acute Coronary Syndrome (ACS) with single de novo~     native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.5 mm and ≤ 20 mm in~     length.~      STUDY DESIGN The REMEDEE OCT study is a prospective, multicenter, randomized study designed~     to enroll 60 patients with ACS who will be randomized 1:1 to be treated with the Combo stent~     versus the commercially available everolimus eluting stent (Xience V or Promus). Patients~     will receive Optical Coherence Tomography (OCT) and Quatitative Coronary Angiography (QCA)~     follow-up imaging at 60 days post procedure. Clinical follow-up is scheduled at 30, 60, 180,~     360 and 540 days. Furthermore, QCA and OCT will also be performed at baseline in all~     participants of the study.~   "
165055|NCT01405274|"~     This study will investigate whether adding a physiotherapy intervention to standard Emergency~     Department care will lead to improved recovery following an ankle sprain in the pediatric and~     adolescent population as well as to a decrease recurrence of injuries during the year~     following the initial ankle sprain. Children will be allocated to standard care or to the~     added intervention group. The study hypothesis is that recovery will be better while~     recurrence of injury will be less in those receiving the added physiotherapy intervention.~   "
165056|NCT01405261|"~     This trial is conducted in Europe. The aim of this trial is to investigate safety,~     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single~     doses of NNC 0113-0987 in healthy male subjects.~   "
165057|NCT01405248|"~     The purpose of this study is to determine whether butylphthalide are effective for Preventing~     Restenosis after Intracranial and Extracranial Artery Stenting~   "
165058|NCT01405235|"~     Current planning for studies involving patients with recurrent, persistent, or metastasized~     cervical cancer must take into consideration that up to 75% of all patients are assumed to~     have already been treated with cisplatin in conjunction with radiation therapy. It seems~     questionable to continue to treat patients with cisplatin when cancer has recurred. Thus, it~     is important to seek alternative active combinations. The studies GOG 169 and 179~     demonstrated that a combination of paclitaxel and cisplatin was superior to a cisplatin~     monotherapy with respect to therapeutic response and progression-free survival, as was a~     combination of topotecan and cisplatin with respect to therapeutic response, progression-free~     survival, and total survival. To achieve further improvement in total survival and to answer~     questions regarding the value of using a platinum-free combination, we propose that a study~     should be conducted to compare the efficacy of a platinum-free combination of paclitaxel and~     topotecan to a combination of cisplatin and topotecan.~   "
165059|NCT01405222|"~     Acute exacerbations of COPD remain a common cause of morbidity and are associated with a~     sustained increase in the normal respiratory symptoms of dyspnoea, cough, and sputum volume~     and purulence. It has previously been shown that a change in cough symptoms occurs in 51.7%~     of exacerbations in COPD. We wish to record cough during a COPD exacerbation to determine~     whether this can be a objective marker of exacerbation duration and severity.~   "
165060|NCT01405209|"~     Atrial fibrillation (AF) is the most common arrhythmia, affecting 1% of adults, with its~     prevalence increasing with age [1]. It is associated with increased morbidity and mortality.~      Most patients who develop AF have architectural and anisotropic micro changes in the atrial~     myocardium. These cause heterogeneous and discontinuous changes in the patterns of impulse~     propagation, heterogeneous atrial activation and shortening of atrial refractory period [2,~     3].~      Since 1911 the standard EKG [4] (approximately 15 seconds of recording and bandwidth 0.05 to~     150 Hz) is the most used tool for the evaluation of patients with arrhythmias, due to its low~     cost and high availability. Various electrocardiographic patterns are known predictors of AF~     as evidenced by direct visual inspection. For example, prolongation of P wave duration during~     sinus rhythm would correlate with structural changes such as increasing the size of the left~     atrium (the increase in left atrial pressure) or a decrease in driving time [5]. These~     changes favor the development of reentry circuits responsible for the development and~     maintenance of AF.~      The registration of the electrocardiographic activity provides much more information than~     evidenced by direct visual inspection. Biosignal processing of these specific techniques to~     detect potential delays caused by abnormal conduction of the myocardium that favor re-entry~     mechanisms [6-10]. For this purpose prolonged ECG with 1000 Hz sampling frequency. Knowledge~     about the prediction of the development of AF with the standard ECG is not obvious on visual~     inspection is limited.~      Many of these structural changes and anisotropic, occur slowly over time and may be evidenced~     by direct variations between 2 ECG from the same individual [11]. Little is known about~     whether differences in morphology, axis, scope or duration of P wave related to these~     structural changes may predict the development of AF.~      Our main purpose is to evaluate the prognostic performance of a set of parameters as~     evidenced by direct inspection of the ECG, and ECG changes from 2 to predict the FA~     development. The design of this tool could allow future generation of software capable of~     identifying and reporting these variations, most useful prognostic risk in patients with AF.~   "
165061|NCT01405196|"~     The objective of this study is to evaluate and compare efficacy of 3 dose levels of~     PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic~     Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory~     measures as well.~   "
165062|NCT01405183|"~     The purpose of this study is to determine if there is an association between hepatitis C~     infection and kidney cancer. All patients who are diagnosed with kidney cancer and who will~     either have a biopsy or surgery will be offered to be tested for hepatitis C. The control~     group will be colon cancer patients. Both groups would be of recent diagnosis (6 months).~   "
165063|NCT01405170|"~     A study to determine whether a new formulation of methylprednisolone suspension is~     bioequivalent to methylprednisolone tablets under fed conditions.~   "
165064|NCT01405157|"~     A study to determine whether a new formulation of methylprednisolone suspension is~     bioequivalent to methylprednisolone tablets under fasting conditions.~   "
165065|NCT01405144|"~     It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic~     keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging~     while treating Aks was reported.~      The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU~     use for forearms photoaging.~   "
165066|NCT01405131|"~     A study to determine whether a new formulation of methylprednisolone suspension is~     bioequivalent to methylprednisolone tablets.~   "
165067|NCT01405118|"~     This study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of~     metformin, a probe drug for organic cationic transport.~   "
165068|NCT01405105|"~     Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative~     colitis.~   "
165069|NCT01405092|"~     Use of on-line blood volume monitoring during continuous renal replacement therapy can~     improve volume management in acute kidney injury patients requiring renal replacement~   "
165071|NCT01405066|"~     The purpose of this study is to quantify variation in radiation dose levels across CT~     technologists, and determine the effectiveness of combining radiation dose audit reports and~     an educational seminar as a means to reduce the variation and level of patient exposure to~     radiation.~      The investigators expect the radiation dose audit reports and educational seminar will lead~     to reduced radiation exposure to patients by making technologists more aware of the risks of~     radiation exposure from CT exams and identifying technologists with higher radiation exams~     compared with their peers.~      The investigators expect the degree to which a technologist is concerned and aware about~     radiation exposure and cancer risk will be associated with adherence to radiation reduction~     protocols and the subsequent level of radiation their patients are exposed to when receiving~     a CT examination.~   "
165072|NCT01405053|"~     This study is designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of~     rufinamide on Lennox-Gastaut Syndrome inadequately controlled in pediatric subjects already~     taking other anti-epileptic drugs.~   "
165073|NCT01405040|"~     The primary objective of this study is to obtain the TPTD, GEDV and EVLW measurements from~     existing indwelling femoral arterial Volume View™ catheter and central venous catheters.~   "
165074|NCT01405027|"~     The purpose of this study is to evaluate the impact of a physician directed education program~     on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated~     interferon, ribavirin and boceprevir.~   "
165075|NCT01405014|"~     The objectives of this research pilot project are to assess the efficacy of the Hold Me Tight~     Relationship Enhancement Program with couples where at least one partner has an acquired~     brain injury.~   "
165076|NCT01405001|"~     This represents the first prospective examination of advanced airway management under combat~     conditions. The findings will have a tremendous impact on both modern prehospital medical~     practice and on the treatment of our wounded Soldiers during the Global War on Terrorism.~   "
165077|NCT01404988|"~     In the VIP (Veterans Intensive Personalized) Treatment in Heart Failure Study we will assess~     2 novel interventions to enhance adherence and improve quality of life in veterans with heart~     failure. This 3-arm randomized controlled trial will base one active arm on how ready~     patients are for change in terms of diet and medication adherence and will tailor the~     intervention based on this. The other active arm will also assess how ready patients are for~     change, but will also include tailoring based on availability of environment resources, such~     as proximity to health food stores or social support, to further tailor the intervention. The~     last active arm is simply an attention group where patients will receive general health~     counseling in addition to background care that all patients receive. The overarching~     hypothesis is that the tailored interventions will lower heart failure (HF) recurrence and~     improve quality of life by better medication and diet adherence compared to attention~     placebo.~   "
165078|NCT01404975|"~     Trans-apical aortic valve replacement is a new treatment for severe aortic stenosis. It is~     offered to elderly patients with medical problems that would markedly increase the risk of~     conventional cardiac surgery. The rate of delirium (acute confusional state) after surgery in~     these patients may exceed 50%. Estimated hospital costs associated with delirium at Toronto~     General Hospital last year exceeded $1-million CAD. Pain after surgery and the use of opioids~     (morphine type of pain-relief drugs) are known to increase the risk of delirium. The~     investigators plan to minimize the use of opioids and improve pain management by replacing~     the standard intravenous opioid-based pain management with the paravertebral nerve block~     using only the local anesthetic. These two management strategies will be compared with~     respect to the rate of delirium, duration of hospital stay, and the overall costs.~      Hypothesis: Paravertebral analgesia with LA decreases the incidence of delirium after~     trans-apical AVR when compared to standard systemic opioid-based analgesia.~   "
165079|NCT01404962|"~     This is a multicenter, post marketing surveillance study which aims to evaluate the safety~     profile of haemophilus influenza type b vaccine when administered to Korean children~     according to the product insert.~   "
165080|NCT01404949|"~     The purpose of this study is to find what effects, good and/or bad, treatment with two drugs~     has on leukemia. The first medicine is tretinoin (also called all-trans retinoic acid, ATRA,~     or Vesanoid). It is an approved medicine that causes the leukemia cells in APL to mature. It~     is related to vitamin A. The second is arsenic trioxide (Trisenox). It is an approved~     medicine for APL that comes back after earlier treatment.~      APL is most often treated with tretinoin and standard chemotherapy drugs. These chemotherapy~     drugs can cause infection and bleeding. They can also damage the heart and normal bone marrow~     cells. This can lead to a second leukemia years later.~      In this study, the investigators are using tretinoin and arsenic trioxide together. Both~     drugs work to treat APL. They have been used together in only a limited number of people. The~     investigators want to use these drugs together to reduce the amount of standard chemotherapy~     and decrease side effects. The patient will receive standard chemotherapy with a drug called~     idarubicin only if they have a higher chance of the leukemia coming back or a higher risk of~     side effects.~   "
165081|NCT01404936|"~     This is a clinical research study of interferon (IFN) plus chemotherapy with the standard~     combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be~     given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD~     improves the immune response against Hodgkin's disease, and will determine whether the~     toxicity of ABVD is increased by adding IFN.~   "
165082|NCT01404923|"~     The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:~        -  Strategy A = MeteoSpasmyl®, on-demand therapy~        -  Strategy B = standard of care chosen by the physician~   "
165096|NCT01404741|"~     5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS),~     but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment~     option but is associated with a high risk treatment-related morbidity and mortality. In the~     current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only~     treatment according to donor availability in elderly patients with MDS (55-70 years).~   "
165097|NCT01404728|"~     This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal~     stenosis in women receiving pelvic radiation therapy for pelvic malignancies.~   "
194243|NCT01020994|"~     The aim of the study is to determine the efficacy and safety of topical application of~     LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema.~   "
165083|NCT01404910|"~     Preeclampsia is a syndrome that occurs in approximately 3% to 8% of pregnancies and is~     associated with considerable maternal and neonatal morbidity and mortality. Except for~     termination of the pregnancy, effective treatments/preventative measures for preeclampsia are~     lacking. Although prolongation of pregnancy benefits the fetus, it is detrimental to the~     mother, and is associated with hypertension, proteinuria, and symptoms that suggest kidney,~     brain, liver and cardiovascular system involvement.~      Placental soluble fms-like tyrosine kinase 1 (sFlt-1) is elevated in women with preeclampsia,~     with levels that fall after delivery. sFlt-1 is a variant of the vascular endothelial growth~     factor (VEGF) receptor Flt-1, and in the circulation, acts as a potent VEGF and placental~     growth factor (PlGF) antagonist. Given that sFlt-1 levels are elevated in preeclampsia, we~     are investigating if removal of sFlt-1 from the plasma of women with preeclampsia can improve~     maternal and fetal outcomes.~      Short-term extracorporeal apheresis with the LIPOSORBER LA-15 System will be the primary~     intervention using methods that have been previously applied in pregnant women with familial~     hypercholesterolemia.~   "
165084|NCT01404897|"~     The Dietary Approaches to Stop Hypertension (DASH) trial has been shown to reduce blood~     pressure and plasma total and LDL-cholesterol (C) compared to a Western diet, but shows no~     benefit on other blood lipid variables associated with cardiovascular disease (CVD) risk,~     namely HDL-cholesterol and triglycerides. The overall objective of this study is to determine~     whether modification of the DASH diet by substituting carbohydrate with fat will result in~     improvements in multiple biomarkers of CVD risk. Specifically, the investigators will test~     the hypotheses that modification of the DASH diet by reducing carbohydrate, primarily in the~     form of simple sugars and glycemic starches, and allowing for a more liberal intake of total~     and saturated fat, primarily from dairy foods, will: (1) improve lipoprotein markers of CVD~     risk (reduced total/HDL-C ratio, apolipoprotein B, small LDL particles, and increased HDL-C,~     apoAI, and large HDL particles); and (2) result in comparable reductions of systolic and~     diastolic blood pressure to those achieved with the standard DASH diet. The investigators~     will also assess the effects of the modified DASH diet on markers of insulin resistance and~     inflammation. Our main hypotheses will be tested by a controlled dietary intervention~     conducted in 40 healthy men and women who will be randomly allocated to consume, for 3 weeks~     each, a control Western diet, a standard DASH diet, and a modified low-carbohydrate DASH~     diet, separated by 2-week washout periods.~   "
165085|NCT01404884|"~     This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACR~     presbyopic excimer laser treatment algorithm for myopic eyes developed for applying to the~     cornea of the human eye in a single center.~      The developed software algorithm uses the subjective refraction of the eye to create a~     treatment for the distance vision correction. This part of the treatment does not show any~     difference to a regular aspheric LASIK treatment for myopic cases.~      In addition to the treatment for the distance vision an additional central ablation component~     will be added to address the near vision.~      The study design is applied as a single center unilateral eye safety and effectiveness study~     of the SUPRACOR presbyopic algorithm for myopia with a 3 months postoperative follow up.~   "
165086|NCT01404871|"~     In this study, the investigators hope to study a number of variables the investigators~     believe may help us predict why some people respond better to some medications than others.~     Participants will be randomly assigned to receive one of two typical medications for OCD,~     clomipramine or escitalopram. Individuals who would like to participate but who have~     previously tried one or both of these medications may instead take a newer drug, duloxetine,~     and undergo the identical procedures. The factors the investigators will be studying include~     demographics (i.e. age, gender, age of onset of OCD), genetic markers (such as variants in~     genes involved in breaking down drugs in the liver (cytochrome P450 system), and genes~     involved in several brain chemical systems, such as serotonin), the dimensions of OCD~     symptoms (i.e. checking, washing, and hoarding) and cortical inhibition. Cortical inhibition~     will be measured transcranial magnetic stimulation and is being studied because deficits in~     this process may be important in the development of OCD. The investigators hypothesize that~     certain pretreatment clinical characteristics will correlate with poor treatment response~     including earlier age of onset, longer duration of illness, increased YBOCS severity and~     presence of significant hoarding symptoms. The investigators expect that increasing degree of~     deficit in CI pre-treatment will predict poor treatment response, but that increase in CI~     from pre- to post-treatment will correlate with a positive treatment response. Differences in~     genetic marker status for cytochrome P450 genes will correlate with tolerability and/or~     response, as well as differences in genetic marker status in SLC1A1, GRIN2B, 5HT1B and 5HT2A~     will correlate with response.~   "
165087|NCT01404858|"~     The purpose of this study is to prospectively examine the impact of various lifestyle habits~     in both men and women on the outcome of in vitro fertilization. There are 25 infertility~     centers in the United States which use the electronic medical record collection entity eIVF,~     made by Practice Highway, to collect medical and demographic information on the patients who~     are undergoing treatment at these centers. Information on every aspect of each cycle is also~     electronically collected daily during each cycle. Demographic and lifestyle information will~     be collected on all patients prior to cycle start and lifestyle habit information will be~     collected each time a patient logs onto the patient portal, which averages every few days.~   "
165098|NCT01404715|"~     This study will address the following question: Does imatinib influence the pharmacokinetics~     of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated~     that imatinib may block metformin elimination from the kidney by inhibiting organic cation~     transporter efflux of metformin. 1. The investigators hypothesize that the addition of~     imatinib to metformin therapy will reduce the renal clearance (CLR) of metformin leading to~     increased plasma concentrations and risk for toxicities 2. Knowledge of the pharmacokinetic~     interaction profile of metformin with organic cation transporter inhibitors, such as~     imatinib, is important to help develop safer more effective drug therapy with reduced side~     effects.~   "
165111|NCT01404546|"~     This pilot study examined the effect of providing a 4 weeks of cost free quit smoking~     medications to smokers identified in a stroke prevention clinic who were interested in~     quitting smoking compared to providing a prescription for the medication only.~   "
166033|NCT01392508|"~     The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used~     as a marker of severe sepsis (including septic shock) in patients presenting to the emergency~     department with suspected infection.~   "
165088|NCT01404845|"~     •Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and~     visual impairment in industrialized countries. The macular pigment, composed of carotenoid~     derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An~     increase in macular pigment following dietary supplementation with lutein and zeaxanthin~     could allow early treatment with such supplements in subjects with a high risk of AMD, and~     encourage them to change their eating habits.~      •Primary outcome:~      Comparative analysis of the density and evolution of the density of macular pigment:~        -  In patients without any retinal pathology who underwent cataract surgery 1 month~          previously~        -  In the non-exudative eye of patients with exudative AMD in one eye by analyzing the~          density and evolution of the density of macular pigment in the non-exudative eye~             -  Secondary outcomes:~      Analysis of changes in macular pigment density after taking food supplements (Nutrof Total~     versus comparator):~        -  Time taken to reach the maximum plateau of macular pigment density (no increase in~          density between 2 measurements)~        -  Time taken to return to the baseline macular pigment density after cessation of~          supplementation~             -  Study design :~      Pilot study -Prospective, randomised, double-masked, comparative, multicenter.~   "
165089|NCT01404832|"~     Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to~     be due to GERD experience only incomplete relief of their symptoms. Those patients are deemed~     PPI failures. Esophageal pH monitoring studies have shown that PPI failure rarely is due to~     persistent acid reflux. Recently, heartburn that is refractory to treatment with PPIs has~     been described in patients with eosinophilic esophagitis, a disorder of unknown etiology in~     which eosinophils infiltrate the squamous epithelium of the esophagus, where they cause~     symptoms and tissue injury. Presently, it is not clear how often eosinophilic esophagitis~     underlies PPI failure for patients with GERD symptoms.~      Purpose: To estimate the frequency with which eosinophilic esophagitis is the cause of PPI~     failure in patients thought to have heartburn due to GERD.~      Methods: Patients referred to the Division of Gastroenterology at the Dallas VA Medical~     Center for the evaluation of heartburn that is refractory to PPI therapy will be invited to~     participate in the study. Patients who provide informed consent will have a medical history~     taken. Women of child bearing potential will have a pregnancy test. The patients' current PPI~     therapy will be discontinued, and patients will be treated with lansoprazole 30 mg BID for~     one week. The patient will return to the clinic one week later. Patients who feel that their~     heartburn has not improved by more than 50% from baseline will have an endoscopic evaluation.~     During the endoscopic examination, biopsy specimens will be taken as follows: A. Two~     specimens from the proximal esophagus at 20 cm from the incisor teeth. B. Two specimens from~     the mid-esophagus at 28 cm from the incisor teeth. C. Two specimens from the distal~     esophagus, 3 cm above the squamo-columnar junction. D. Two specimens from the distal~     esophagus, 1 cm above the squamo-columnar junction. E. Two specimens from the second portion~     of the duodenum (to see if the eosinophilia is confined to the esophagus, or part of a more~     extensive eosinophilic gastroenteritis). A diagnosis of eosinophilic esophagitis will be made~     if there is at least one high-power field with >25 eosinophils, or two or more high-power~     fields with >15 eosinophils.~      Potential Benefits: This study will provide an estimate on the frequency with which~     eosinophilic esophagitis is the cause of PPI failure in patients thought to have heartburn~     due to GERD. This has substantial potential importance for patient management.~   "
165090|NCT01404819|"~     The objective of this study is to show that, in patients undergoing carotid endarterectomy,~     brain damage, assessed by the determination of S100B before removing the clamp, is less~     severe with a balanced anesthesia consisting of remifentanil combined with Xenon~     (experimental arm) compared with remifentanil anesthesia associated with propofol (reference~     arm).~   "
165091|NCT01404806|"~     The purpose of this study is to describe drug concentrations of an investigational HIV~     medication, GSK1349572, in blood plasma, cervicovaginal fluid, vaginal and cervical tissue in~     HIV negative women.~   "
165092|NCT01404793|"~     Standard anesthetic management of liver transplantation patients includes a general~     anesthetic using multiple drugs, including the neuromuscular relaxant rocuronium.~     Pharmacokinetic modelling of this agent has been poorly described during liver~     transplantation, which impacts on appropriate dosing of this agent within this population~     where plasma concentrations can vary with fluid shifts and hepatic drug metabolism during the~     various phases of liver transplantation. Plasma drug and drug metabolite concentrations will~     be measured using the technique of solid phase micro-extraction (SPME). Measuring and~     correlating the levels of rocuronium and other liver metabolites with the degree of post~     transplantation hepatic dysfunction may serve as a simple and cost-effective marker to aid~     diagnosis, identify those at risk of hepatic dysfunction and potentially grade the severity~   "
165093|NCT01404780|"~     Patients undergoing chest surgery often require insertion of a breathing tube (double lumen~     tube) after they are unconscious. The double lumen tube enables the anaesthetist to ventilate~     (assist breathing) one lung at a time. The other lung is partially deflated to enable enough~     space for the surgeon to perform the procedure. The breathing tube is inserted with a~     laryngoscope (blade with a light at the end) so the vocal cords can be seen. This is standard~     medical practise. Two laryngoscopes are commonly used at Toronto General Hospital to insert~     the tube. The Macintosh laryngoscope has been is use for over 50 years and the Glidescope for~     over 10 years. Both devices have been extensively researched for single lumen tubes insertion~     and found to be very safe and effective. Research is limited to say which of the two~     laryngoscope is the most effective for double lumen tubes.~   "
165094|NCT01404767|"~     This study proposes to assess the effect of the standard of care, which is continuation of~     the pre op beta blocker dose into the post operative period compared to the administration of~     esmolol titrated to a pre determined target HR. The primary outcome will compare~     postoperative plasma levels of metoprolol in 2 cohorts in a group who has been continued on~     metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been~     withdrawn from metoprolol but given an esmolol infusion titrated to HR. Secondary outcomes~     will compare a) the hemodynamic responses, documenting the incidence of unplanned hypotension~     and bradycardia and b) to compare the effects of Heart rate to the incidence of myocardial~     ischemia, arrhythmias, delirium and infarction.~   "
165095|NCT01404754|"~     This study will compare the effects of methylenedioxymethamphetamine (MDMA) and placebo on~     mood and psychological experience in people trained to practice MDMA-assistant psychotherapy~     in a therapy-like setting. Study participants will prepare for the experience with the~     investigators. After preparation, they will have two day-long sessions, one with placebo and~     one with MDMA, with the second session happening two days after the first. Order of session~     will be assigned randomly and the study will be double-blind. Subjects will complete measures~     and talk about the experience on the day after each session. Mood, psychological symptoms,~     and interpersonal closeness will be measured before and after each session. The investigators~     will speak with subjects again one and two months after the second experimental session, and~     subjects will complete a personality questionnaire two months after the second experimental~     session.~   "
165108|NCT01404585|"~     The purpose of this study is to assess whether BMS-817399 in combination with Methotrexate is~     effective in treating moderate to severe rheumatoid arthritis.~   "
165099|NCT01404702|"~     Neuroblastoma (NB) is the most common extracranial solid tumor in children, with an annual~     incidence of 10.5 per million children less than 15 years of age. NB accounts for 15% of~     childhood cancer deaths. High risk (HR) patients carry a poor prognosis despite treatment~     with intensive chemotherapy, surgery and/or radiation, autologous bone marrow transplant, and~     treatment with cis-retinoic acid. New therapies are desperately needed for such patients.~     Recently, it has been demonstrated that HR NB patients benefit from anti-GD2 antibody therapy~     which directs the immune system against NB cells. To further explore means of harnessing the~     immune system to attack NB, the investigators are studying the combination of zoledronic acid~     (ZOL) and interleukin-2 (IL-2). ZOL has been demonstrated to have direct anti-neuroblastoma~     effects in laboratory studies. ZOL also augments the production of tumor killing white blood~     cells called gamma-delta T cells. When used in combination with IL-2, ZOL is capable of~     eliciting potent anti-cancer effects in patients, in part, via the expansion of gamma-delta T~     cells. In this present trial the investigators aim to study the tolerability of the~     combination of ZOL and IL-2 in pediatric NB patients. Patients will also be monitored~     radiologically for tumor response to therapy. Correlative biological studies will study the~     ability of this drug combination to elicit the production of NB killing gamma-delta T cells~     in children.~   "
165100|NCT01404689|"~     Endoscopic retrograde cholangiopancreatography (ERCP) takes a longer time and is more complex~     to perform than the other parallel procedures, causing discomfort to patients. It is commonly~     performed under sedation endoscopy. Until recently, the combination administration of~     midazolam and opioid has been widely used as standard therapy due to its superior sedation~     effect compared to the other sedation agents. Midazolam, however, has problems, such as an~     insufficient sedation effect and an intermittent paradoxical response.~      Unlike midazolam, propofol has no antagonist and may cause problems such as respiratory~     depression, and has a narrow therapeutic range for the sedation effect, consequently~     requiring supervision by experienced experts, although it has a better sedation effect than~     midazolam. Due to these disadvantages, propofol is clinically less useful than midazolam.~      Meanwhile, dexmedetomidine, a selective α2 adrenergic agonist, is known to maintain the~     proper level of sedation and has a weak influence on respiratory depression. Recent studies~     have shown positive results with dexmedetomidine in relation with the sedation effect for~     surgery patients under local anesthesia or in intensive care units.~      As such, extensive studies are being conducted on the use of dexmedetomidine in endoscopic~     procedures due to the increased attention to dexmedetomidine. This notwithstanding, the~     clinical usefulness of dexmedetomidine is still debatable. In particular, studies on the use~     of dexmedetomidine for ERCP are very rare.~      Given the recent idea that dexmedetomidine may exert a synergistic effect in combination with~     midazolam, these authors endeavored to prospectively compare and analyze the sedation effect~     and adverse events, including respiratory depression, of the combination therapy of midazolam~     and meperidine, both of which have been widely used in patients undergoing ERCP, and of the~     combination therapy of midazolam, meperidine, and dexmedetomidine.~      The small-scale comparative study on the combination administration of propofol and fentanyl,~     which has a high risk of causing complications, and on the single administration of~     dexmedetomidine is the only study on the sedation effect of dexmedetomidine in the ERCP~     procedure that has yet been conducted; there has been no study that investigated the effect~     of the combination administration of dexmedetomidine and other drugs in the ERCP procedure.~     This study is thus expected to contribute to the development of guidelines on sedation in the~     ERCP procedure.~   "
165101|NCT01404676|"~     The effect of vildagliptin based treatment versus sulfonylurea based treatment on glycemic~     variability, oxidative stress, and endothelial function in patients with type 2 diabetes.~   "
165102|NCT01404663|"~     Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can~     involve brain and nervous system functions such as movement, learning, hearing, seeing, and~     thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these~     problems occur as the baby grows in the womb, but they can happen at any time during the~     first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem~     cells are known as a effective therapy.~      In this study the investigators evaluate the side effect of bone marrow stem cell~     transplantation in patients with cerebral palsy.~   "
165103|NCT01404650|"~     This is a multicenter, non-randomized, single agent, Phase II study of AUY922 in patients~     with refractory Gastrointestinal Stromal Tumor (GIST). The primary endpoint of this study is~     to determine progression-free survival (PFS) for patients with GIST receiving AUY922~     intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle with restaging at 6 and~     12 weeks and then every 9 weeks thereafter. Patients may continue treatment until evidence of~     disease progression.~   "
165104|NCT01404637|"~     The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal®~     D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic~     benign prostatic hyperplasia as a first line therapy.~   "
165105|NCT01404624|"~     The problem point of the Prader-Willi Syndrome (PWS) patient is the obesity which is intense~     and the plasma ghrelin level which increases unusual from the recently PWS patients was~     discovered. The Ghrelin is endogeneous ligand of growth hormone secretagogue receptor with~     peptide hormone and the location is 3p26-p25. Becomes the secretion even from nervous system~     but from dignity X/A cell it is secreted mainly and growth is important even in the vagal~     control against food and intake and a dignity function even on the action outside which~     promotes the secretion which drives it operates. It increases food intake specially and in~     order to accomplish the action which diminishes fat utilization the obesity with the week~     cause which it does the mortar it is thought. Active the ghrelin of the form is essential in~     hormonal activity of the ghrelin and appetite and growth hormone it participates to the~     secretion promotion which drives. Action of the Ghrelin measuring the quantitative change in~     middle acylated of the PWS patient ghrelin in order to happen after the acylation initially~     by one interest ghrelin which is attempted the appetite of the PWS patient is is controlled~     the method it will be able to prove the thing directly, it used the RIA kit and the ELISA it~     will be able to measure kit it will be able to measure the whole ghrelin to pick the PWS~     patient and the blood of the normal army and active ghrelin it measured a change.~   "
165106|NCT01404611|"~     The purpose of this study is to determine if a combination of an antibiotic plus a~     corticosteroid is safe and effective in treating middle ear infections in children with ear~     tubes.~   "
165107|NCT01404598|"~     This study will be performed in 2 parts conducted in parallel:~      Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen~     500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the~     pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the~     elimination of the drug after its administration) of nitrates (metabolite of naproxcinod)~     present in plasma, saliva and urine after oral administration of naproxcinod 750 mg bid for 7~     days or naproxen 500 mg bid for 7 days as a reference.~      Part 2 (conducted on 8 healthy subjects): Administration of a single dose of naproxcinod 3000~     mg. The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the~     absorption, the distribution, the metabolism and the elimination of the drug after its~     administration) of Gamma-Hydroxybutyric Acid (GHB), a compound resulting from the~     transformation of the naproxcinod, after oral administration of a single supratherapeutic~     dose of 3000 mg.~   "
165112|NCT01404533|"~     The overall goal of this research is to develop safe and effective iron interventions that~     can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in~     the systemic circulation not bound to the iron-transport protein transferrin). The appearance~     of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after~     oral administration of iron supplements in doses similar to those used in the Pemba trial.~     This research project will (i) confirm the appearance of plasma non-transferrin-bound iron~     after administration of an iron supplement like that in the Pemba trial (~1 mg Fe/kg body~     weight, without food), and then determine the effects on production of plasma~     non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of~     giving the supplemental iron (~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a~     lower dose of iron (~0.1 mg Fe/kg) — like that used in home fortification — with the standard~     rice meal.~   "
165113|NCT01404520|"~     The purpose of this study is to test a new preventive and restorative intervention for~     patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate~     the patients' treatment related symptom burden and to explore the effect of the intervention~     on length of hospital stay, duration of sick leave and return to work status. Further, to~     examine the relationship of the symptom profile with clinical indicators, physiological~     response, physical performance and survival.~   "
165114|NCT01404507|"~     The routine use of glycoprotein (Gp) IIb-IIIa inhibitor such as abciximab is not recommended~     by current ACC/AHA guideline (Class IIb, level of evidence of A). This may be partly due to~     potential increase of bleeding. Compared bolus injection followed by continuous infusion of~     Gp IIb-IIIa inhibitor, single bolus administration was proposed to decrease bleeding~     complication while maintaining decrease ischemic events. It was also reported that direct~     intracoronary injection of abciximab might be superior to intravenous injection regarding~     myocardial perfusion.~      Aspiration thrombectomy is regarded as important adjunctive therapy in the treatment of acute~     ST-elevation myocardial infarction (IIa, level of evidence of B). We hypothesized that~     combination of intracoronary abciximab bolus injection and aspiration thrombectomy might~     enhance adequate myocardial perfusion in patient with acute ST-elevation myocardial~     infarction. We will determine whether combination of intracoronary abciximab injection and~     aspiration thrombectomy is superior to each treatment only in terms of myocardial perfusion~     through index of microcirculatory resistance and cardiac magnetic resonance imaging.~   "
165115|NCT01404494|"~     Background:~      - Previous studies have shown that computer-based devices that simulate everyday tasks can be~     helpful for evaluation and rehabilitation in people who have had strokes. Researchers are~     interested in studying whether similar devices can be used to evaluate and treat individuals~     who have had a traumatic brain injury, to determine if the device should be developed to help~     with rehabilitation in the future.~      Objectives:~      - To evaluate the effectiveness of a computer-based simulation compared with actual~     performance of actions in individuals who have had a traumatic brain injury.~      Eligibility:~      - Individuals at least 18 years of age who have had a non-penetrating mild or moderate~     traumatic head injury within the past year and have experience playing computer games.~      Design:~        -  Participants will be screened with a physical and neurological examination and medical~          history.~        -  Participants will complete questionnaires and an interview about mood and feelings,~          stress levels, quality of life, and how well they function at work or at home.~          Participants will also have tests of memory, attention, thinking, and reasoning. Some of~          the questionnaires and tests will be completed in writing, some orally, and some on a~          computer.~        -  Participants will have movement and coordination tests that involve simple tasks such as~          putting pegs in a pegboard, using a key, lifting different objects, and folding things.~        -  Participants will duplicate the movement and coordination tests by using a computer~          program that simulates the tasks with a cursor on a computer screen. Participants will~          do four separate simulated tasks (such as arranging letters or hitting a nail with a~          hammer) three times.~        -  The full visit will take about 4 hours, and no followup visits are required.~   "
165116|NCT01404481|"~     The purpose of the study is to compare single use of catheters with reuse of catheters for~     intermittant self catheterisation.~   "
165117|NCT01404468|"~     The optimisation of drug absorption through skin is of great value in modern~     therapy.Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug~     absorption. However,few studies have compared pulsed and continuous modes of therapeutic~     ultrasound.This study compared these two modes by investigating the effect of lidocaine~     phonophoresis on sensory blockade.~      Ninety-three healthy volunteers, assigned at random to one of three ultrasound~     groups:pulsed(ultrasound+lidocaine),continuous(ultrasound+lidocaine)and control(sham~     ultrasound+lidocaine).~      Lidocaine was administered transdermally using a transducer.Two point discrimination, touch~     and maximum pain thresholds were assessed before and after the intervention in each group.~      Pulsed ultrasound with topical lidocaine gel induced greater anaesthetic effect compared with~     continuous ultrasound with topical lidocaine gel and lidocaine application alone. The~     mechanical properties of pulsed ultrasound appear to be responsible for greater drug~     penetration.~   "
165118|NCT01404455|"~     The investigators examined the predictability of stroke volume variation for fluid~     responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery~     bypass graft~   "
165119|NCT01404442|"~     Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an~     additive to bupivacaine in patients undergoing cesarean section .~      Methods:Following Ethics Committee approval and informed patients consent, Ninety patients~     18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal~     anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were~     randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received~     bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group~     (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group~     (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time~     to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level~     , onset of motor block, duration of blockade, hemodynamics variables, the incidence of~     hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen~     (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation,~     dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were~     instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain,~     10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient~     requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for~     post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of~     administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.~   "
165167|NCT01403818|"~     This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide~     calcium hydrate in healthy volunteers.~   "
165120|NCT01404429|"~     To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in~     patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2~     weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy)~     versus the adverse effects.~      Hypothesis: There will be no difference in the adverse effects, but better and faster control~     of disease when starting with a higher methotrexate dose~   "
165121|NCT01404416|"~     The follow-up study was based on our previous nutritional intervention trial entitled Impact~     of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744). We followed up~     all livebirths born to women of the trial to measure their height, weight, and hemoglobin and~     to implement a questionaire survey (including developmental milestones, disease history,~     breast feeding, passive smoking, et al). We selected a sub-sample of infants to assess their~     IQ, emotional and behavioral problem, and language development status. The outcomes of~     interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness,~     anemia, developmental milestones, IQ, emotional and behavioral disorder, language~     developmental status, and disease history. Other interesting exposure includes breast~     feeding, passive smoking, et al. We hypothesize that intrauterine nutritional exposure has an~     impact on offspring's physical, mental, and language development. We also hypothesize that~     cesarean delivery including CDMR has an impact on offspring's these outcomes.~   "
165122|NCT01404403|"~     This is a safety study of the Rapid System for acute ischemic stroke.~   "
165123|NCT01404390|"~     This study will be conducted as an open label, single centre, Phase I study of PI3K~     (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or~     refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8~     and Day 15 with three weeks on and one week off in each treatment cycle.~   "
165124|NCT01404377|"~     Prospective double blind randomized evaluation of the effect of surgical wound infiltration~     with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph~     node dissection~   "
165125|NCT01404364|"~     The purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and~     retrobulbar chlorpromazine as alternatives in the management of ocular pain in blind eyes.~   "
165126|NCT01404351|"~     The objective of this clinical study is to evaluate the operative performance of the PEAK~     PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative~     pain, adverse events and skin scarring following surgery; and to compare these outcomes to~     the HARMONIC SYNERGY® BLADE.~   "
165127|NCT01404338|"~     Tachyphylaxis occurs when a medication is applied multiple times and a decreased response~     takes place. Many dermatologists believe that tachyphylaxis to topical steroids commonly~     occur. Other believe that tachyphylaxis can be explain by patient non-compliance with topical~     medications. This study is looking to prove or disprove the phenomenon of tachyphylaxis by~     using topical steroids in the psoriasis patient population. The investigators are looking to~     enroll 10 patients with symmetric, bilateral, and small psoriasis plaques. The investigators~     will either apply a strong topical steroid or a vehicle ointment to the plaques, which is be~     occluded with a band aid for a one week period. Weekly, the investigators will inspect the~     plaques for tachyphylaxis. This regimen will be repeated during phase 2, to see if there is~     change in the time to tachyphylaxis. This regimen will be repeated during phase 3, however,~     both plaques will be treated with steroid in this phase, and time to tachyphylaxis will be~     measured.~   "
165128|NCT01404325|"~     This trial will evaluate the efficacy of Everolimus in combination with a centre specific~     standard immunosuppressive regimen versus a standard immunosuppressive regimen concerning~     kidney function in lung transplant recipients.~   "
165129|NCT01404312|"~     HIV-infected people have an increased risk of developing active tuberculosis (TB). The~     standard course of treatment for TB is 6 to 9 months of isoniazid (INH). A shorter course of~     treatment may be as effective and potentially increase treatment adherence. This study will~     compare the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus~     a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active~     TB.~   "
165130|NCT01404299|"~     The purpose of this study is to determine whether protein-energy nutritional supplementation~     improves geriatric function in community-dwelling frail older adults of low socioeconomic~     status.~   "
165131|NCT01404286|"~     Purpose: The objective of this study was to evaluate the influence of a session of resistance~     training on the sleep patterns of elderly people.~      Methods: Forty men aged 65 to 80 years, sedentary and clinically healthy were divided into~     two groups: the control group (n=18) and the resistance group (n=22). Both groups underwent~     two polysomnography tests, one at baseline and another after either a resistance training~     session (One Repetition Maximum - Strength Test, resistance group) or without physical~     exercise (control group).~   "
165132|NCT01404273|"~     This research study is being done to examine how meditation and the relaxation response (RR)~     may change brain activity in attention-deficit/hyperactivity disorder (ADHD).~   "
165133|NCT01404260|"~     Platinum-based combination chemotherapy, such as gemcitabine-carboplatin, is one of the~     standard first-line therapy for advanced non-small cell lung cancer (NSCLC).~      Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) have clinical~     efficacy, as compared with the best supportive care or standard chemotherapy, when given as~     second-line or third-line therapy for advanced NSCLC.~      Treatment with EGFR-TKI is most effective in female, never-smoker, or patients with~     adenocarcinoma, and patients of Asian origin. In these populations, such treatment is~     associated with favorable objective response rates, progression-free survival, and overall~     survival. These populations also have a relatively high incidence of somatic mutations in the~     region of the EGFR gene that encodes the tyrosine kinase domain.~      The recent study(IPASS) by Tony S. Mok showed gefitinib was superior to~     carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers~     or former light smokers in East Asia . In the subgroup of 261 patients who were positive for~     the EGFR gene mutation, PFS was significantly longer among those who received gefitinib than~     among those who received carboplatin-paclitaxel(HR= 0.48,P<0.001), whereas in the subgroup of~     176 patients who were negative for the mutation, PFS was significantly longer among those who~     received carboplatin-paclitaxel(HR=2.85,P<0.001). Gefitinib treatment was well tolerated,~     with lower in hematologic toxicity, and no treatment-related interstitial lung disease.In~     this study(IPASS), only patients with a mutation of the EGFR gene in the tumor could get~     benefit from gefitinib as first line treatment.~      Tony S. Mok and his colleague also found that intercalating and maintenance administration of~     erlotinib(another EGFR-TKI)following gemcitabine/platinum chemotherapy as first line therapy~     led to a significant improvement in PFS .~   "
165168|NCT01403805|"~     Prospective study comparing the effects of interventions (combined oral care and pneumococcal~     plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from~     pneumonia.~   "
165134|NCT01404247|"~     Brief Summary~      The purpose of this study is to better characterize the retina and optic nerve in newborns~     using spectral domain optical coherence tomography (s-oct). This new technology provides a~     very detailed cross-section picture of the cellular layers in the retina and a 3-dimensional~     picture of the optic nerve head and the fovea (the center of the retina that provides the~     most accurate vision). These images have been used by doctors for more than 5 years to help~     diagnose and treat adults with eye diseases, such as macular degeneration, diabetic~     retinopathy, retinal detachments, and melanoma. But, it has never been studied in newborns.~     In newborns, it would potentially help in the diagnoses of glaucoma, optic nerve hypoplasia,~     foveal hypoplasia, and colobomata among many other disorders. Prior to diagnosing disorders,~     it is necessary to establish normal values. It is the purpose of this investigation to study~     the retina and optic nerves in neonates to establish normal values.~      After a parent of a normal newborn provides a written consent, the baby will be taken to the~     Eye Clinic where the instrument is located. The baby will be swaddled in one or more blankets~     as needed. The infants will be held in front of the instrument by a nurse. The technician~     will move the lens of the instrument to about 2 to 4 inches from the baby's eye. The mild~     light from the instrument will then enter the eye for a few seconds to obtain the desired~     image. The image can be captured through an immobile eye within 5 seconds. If the baby is~     fussy, he or she may be given a few drops of a sugar (sucrose) solution on a pacifier for~     calming. Although the images can usually be secured through a normal pupil, if the pupil is~     found to be too small, two drops of Cyclomydril will be placed on the eye for dilation. This~     is the eye drop used everyday in the Eye Clinic and nursery to dilate the pupils of babies.~     The dilation will last for about 6 to 10 hours. After the test, the baby will return to the~     nursery or be discharged home as intended by the Neonatology Division.~      There is minimal risk associated with this investigation. The instrument is non-invasive and~     does not touch the eye. The babies will be swaddled and held by a nurse to prevent any~     contact with the machine. The eye drop to be used if needed for dilation has been used on~     babies at Harbor for about 30 years. It has been found to very safe. The fact that we will~     study only term (not premature babies) and will apply only two drops if needed should~     minimize any risk from the eye drop.~      An ethical issue to consider is that while the study will provide important information that~     will undoubtedly help babies in the future, it will probably not benefit the baby being~     studied. However, if the baby has an undetected retinal or optic nerve problem, the study may~     reveal it.~   "
165135|NCT01404234|"~     This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis~     (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three~     28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each~     followed by 28 days off AZLI. The total treatment duration was to be 6 months.~   "
165136|NCT01404221|"~     Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of~     the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies~     and predict maternal and fetal complications?~   "
165137|NCT01404208|"~     The purpose of this study is to find out if D-Cycloserine (DCS), taken at the same time as a~     child gets cognitive behavioral therapy (CBT) can help children with pediatric~     obsessive-compulsive disorder.~      Cognitive Behavior Therapy is a talking therapy that will teach children new skills to better~     cope with his/her OCD. CBT usually uses exposure-based therapy. This means that the person~     with OCD slowly learns to deal with things they usually avoid. This is done by moving from~     less stressful situations to more challenging ones.~      The investigators hope to enroll about 75 children ages 7-17 years old with OCD in this study~     at Massachusetts General Hospital (MGH). The National Institute of Mental Health (NIMH) is~     paying for this study to be done.~      If your child qualifies for the study, the investigators will assign him or her by chance~     (like a coin toss) to either the DCS group or the placebo group. You and the study doctor~     cannot choose your child's study group. Your child will have an equal chance (1 in 2) of~     being assigned to the DCS group.~      Your child will be asked to take one or two capsules of the study drug (either DCS or~     placebo, depending which study group they were assigned to) one hour before CBT visits 4-10.~     The study coordinator will give your child the study drug at the location of the CBT~     sessions. This is to make sure that your child takes the study drug one hour before his/her~     scheduled therapy session. We will ask you to record any bad side effect from the study drug~     that your child may have before each CBT session.~      It will take your child about 34 weeks to complete the study. During this time, the~     investigators will ask you and your child to make a minimum of 17 trips to the study center.~     There may be up to 23 trips when including CBT Booster sessions.~      This study uses a placebo. The placebo looks exactly like the DCS, but it contains no DCS.~     The investigators use placebos in research studies to learn if the the results are caused by~     the study drug or are due to other reasons. This is a double-blind study. A double-blind~     study is a study where both the doctor and the study participant do not know whether the~     study participant is being given DCS or placebo.~   "
165138|NCT01404195|"~     1. RATIONALE The unique characteristic of our study lies in the attempt to reverse the~          functional impairment experienced by sarcopenic patients with hip fracture using~          nutritional intervention. What makes this study different from prior studies is that it~          will be conducted in a hospital setting, unlike most prior studies, which were conducted~          in a community setting. The association between muscle mass and strength, inflammatory~          indices, and functional impairment versus dependence and fragility will also be~          measured.~        2. HYPOTHESIS The hypothesis of our study is that nutritional intervention enriched in~          metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective for~          treating sarcopenia in elderly patients with hip fracture and improves functional level.~        3. OBJECTIVES Primary objective is to assess functional improvement after nutritional~          intervention in sarcopenic patients with hip fracture, as measured using Barthel index.~           Secondary objectives will include: 1) to show the relationship between metabolic and~          inflammatory indices and sarcopenia; 2) to show how sarcopenia and its treatment~          influence the risk of fall; 3) to show muscle mass improvement; 4) to show increased~          strength; 5) to assess mortality and morbidity.~        4. EXPECTED RESULTS The investigators expect to find that the supplemented group~          experiences throughout the study period a significant improvement in functional status~          (Barthel index), an increase in muscle mass, and a reduction in fat mass. An increased~          strength and a reduction in associated complications (falls) are also expected. The~          investigators hope to be able to show reductions in inflammatory indices and insulin~          resistance.~      To conclude, by improving muscle strength and mass the investigators expect to find a~     reduction in the disability and dependence of this population group.~   "
165139|NCT01404182|"~     The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB~     trivalent influenza vaccine in adults and elderly people.~   "
165140|NCT01404169|"~     The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy~     compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's~     Disease.~   "
165141|NCT01404156|"~     The best treatment for resectable esophageal or gastroesophageal adenocarcinoma is unknown.~     Although an operation to remove the esophagus is the most common treatment, previous studies~     have shown that patients live longer when either perioperative (before and after surgery)~     chemotherapy or preoperative (before surgery) chemotherapy plus radiation is given, compared~     to surgery alone. However it is unknown which of these treatments (perioperative chemotherapy~     or preoperative chemoradiation) is more effective in improving survival. A study where~     patients with resectable esophageal / GE junction cancer are chosen at random to receive one~     of the two preoperative treatments would help determine if one form of treatment improves~     survival compared to the other.~      Patients with localized esophageal / GE junction cancer (adenocarcinoma) will be randomized~     to receive either preoperative and postoperative chemotherapy or preoperative chemoradiation~     followed by surgery.~      The main objective of this pilot trial is to determine the possibility of conducting a larger~     study with many centers participating. If this study proves to be feasible with enough~     patients enrolled and able to tolerate treatments without major side effects then we can~     hopefully proceed to perform a larger multi-center trial to look for survival outcome~     differences between patients who receive preoperative chemotherapy and those who receive~     preoperative chemoradiation. The results of this trial would ultimately help us choose the~     most effective treatment of resectable esophageal cancer and hopefully improve survival.~   "
165253|NCT01402687|"~     The goal of this study is to gain new knowledge about genetic risk factors thta may affect~     the development of mucositis, the chemotherapy-induced sores in the mouth and esophagus~     following HSCT. The study seeks to understand if different forms of genes result in an~     increased risk of sores in the mouth and esophagus.~   "
165142|NCT01404143|"~     What is the difference in subscapularis strength between two different methods of~     subscapularis mobilization: incision of the tendon (tenotomy) versus peel, as measured by a~     hand-held dynamometer in the belly-press position at one year post operative? It is the~     investigators' hypothesis that a peel of the subscapularis will result in greater strength, a~     higher healing rate, and a greater improvement in shoulder function and quality of life~     following shoulder replacement.~   "
165143|NCT01404130|"~     This prospective study tested the effects of isotretinoin in a cohort of patients receiving~     standard therapy for acne vulgaris. Subjects completed questionnaires and standardised~     computer based cognitive testing using CANTAB to test for cognitive effects particularly on~     learning and memory. Test were conducted before starting isotretinoin, after 3 months and~     again a month after finishing therapy. This was carried out as a pilot study to~        1. Test the hypothesis that oral isotretinoin, over its 4-month treatment time, will result~          in a decline in learning and memory as measured using the CANTAB series of test.~        2. Generate data for sample size calculation for a larger study to determine the changes in~          memory over time in drug and control group~        3. Test of CANTAB, questionnaires and data collection forms~        4. Select most appropriate outcome measures~        5. Identify therapy sensitive cognitive tasks which would be used in future functional~          brain imaging studies It was not considered to randomise subjects to placebo.~   "
165144|NCT01404117|"~     A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled~     study to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod~     (0.6mg or 1.2mg) in adjunct to glatiramer acetate (GA) or interferon-beta (IFN-B) in~     relapsing remitting multiple sclerosis (RRMS) subjects~   "
165145|NCT01404104|"~     Temsirolimus is a drug that is being studied to possibly treat kidney cancer. It works by~     starving the cancer of nutrients, by cutting off the blood supply, which is hoping to shrink~     the cancer. This study will look at the experimental use of temsirolimus, 12 weeks prior to~     the surgical removal of the entire kidney or a portion of the kidney that is involved by the~     tumor.~   "
165146|NCT01404091|"~     The purpose of this trial is to conduct an assessment of brain nociceptin/orphanin FQ peptide~     (NOP) receptor occupancy (RO) in healthy subjects.~   "
165147|NCT01404078|"~     This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy~     tolerability of low strength Polycap versus two doses of low strength Polycap in patients~     with stable cardiovascular disease in reducing blood pressure and LDL.~      To evaluate the tolerability and safety of low dose potassium supplementation compared to~     placebo in patients with stable cardiovascular disease.~      Approximately 500 patients are planned to be randomized.~   "
165148|NCT01404065|"~     The purpose of this study is to investigate the effects of Transcranial Direct Current~     Stimulation (tDCS) combined with watching a visual illusion on chronic pain due to spinal~     cord injury. The investigators hypothesize that active tDCS will reduce pain in subjects with~     spinal cord injury when compared to sham stimulation. The investigators will also measure~     changes in EEG data (alpha and beta frequencies) as well as motor cortex excitability.~   "
165149|NCT01404052|"~     The purpose of this study is to see the effects of transcranial direct current stimulation~     (tDCS) on the pain associated with osteoarthritis of the knee. The investigators hypothesize~     that there will be a decrease in pain levels with active stimulation, when compared to sham~     stimulation. Before, during and after stimulation, the investigators will measure and assess~     changes intracranial blood flow with transcranial ultrasound.~   "
165150|NCT01404039|"~     The purpose of this study is to investigate the effects of different types of interventions~     (motor learning, somatosensory learning, observation task, mental imagery and tDCS) on the~     perception of pain and motor cortex excitability in healthy male subjects. This is an~     exploratory study of healthy subjects only.~   "
165151|NCT01404026|"~     The purpose of this study is to investigate the effects of transcranial direct current~     stimulation (tDCS) on the neuropathic symptoms (pain/itch) due to a burn injury. The~     investigators hypothesize that the active tDCS group will show a significant pain/itch~     reduction when compared to sham stimulation.~   "
165152|NCT01404013|"~     This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone~     or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA).~      The investigators hypothesize:~        1. Cough score and cough reflex sensitivity will be improved after treatment with~          montelukast, inhaled corticosteroid/β2 agonist(ICS/LABA), and two combinations.~        2. Combination of leukotriene modulator and inhaled corticosteroid/β2 agonist may have~          better efficacy when compared to montelukast, corticosteroid/β2 agonist alone while MON,~          is comparable to symbicort.~   "
165153|NCT01404000|"~     The purpose of this study s to determine whether treatment with Iodinated Active Charcoal can~     improve lung function and physical capacity in patients with chronic obstructive lung~     disorders. The rational for the study is the observation that COPD patients have an increased~     tissue load of mercury interfering with the function by NeuroEpithelial Endocrine (NEE) cells~     in the respiratory tract. Mercury binding to these NEE cells leads to an increased smooth~     muscle tonus and a reduced response to bronchodilator treatment. Initial observational data~     have shown an improved lung function and improved functional capacity after treatment~     motivating a larger placebo controlled POC study~   "
165169|NCT01403792|"~     The purpose of this study is to assess the safety and tolerability of intravaginal~     administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1~     will receive up to 7mg of P2G12, or placebo. Three subjects in Group 2 will receive up to~     14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or~     placebo. A safety review will take place before subjects in Groups 2 and 3 receive study drug~     to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical~     inspections will be performed to determine what effect, if any, the study drug has had on the~     site of administration. Adverse event data will be collected throughout the trial.~   "
165254|NCT01402674|"~     Phentermine, an amphetamine congener, is the most widely used anti-obesity drug in the U.S.~     Although phentermine is the agent-of-choice among physicians specializing in obesity~     treatment, the use of this drug for obesity treatment by other physicians has long been~     curtailed because misapprehensions regarding phentermine safety. Concerns of~     phentermine-induced adverse cardiovascular reactions and of phentermine-induced addiction are~     two fears that have had a profound negative impact on phentermine prescribing. Although~     warnings of high incidence rates of adverse cardiovascular and psychiatric effects are~     included in FDA labeling and are often repeated in published reviews, the few clinical~     reports in the peer-reviewed medical literature of such adverse effects are anecdotal. Fear~     of phentermine adverse effects does not inhibit the use of phentermine by obesity treatment~     specialists. A 2008 survey of prescribing practices found that 98% of bariatric medicine~     specialists used pharmacotherapy in treating obesity and that 97% of those prescribed~     phentermine as their first choice.~      The fear that phentermine has addiction potential appears to be a factor influencing~     curtailment of use. At the time that phentermine was approved in 1959 the expectations were~     that it would prove to be addicting, although perhaps less so than amphetamine. These~     expectations were based on the chemical structural similarities between phentermine and~     amphetamine and on evidence in rats that phentermine stimulated spontaneous activity. No~     evidence suggesting the drug had human addiction potential appeared in clinical trials~     conducted prior to approval.~      After 52 years of use there is no evidence in the peer-reviewed medical literature to support~     the hypothesis that phentermine has significant human addiction potential. Research in~     addiction medicine has undergone significant development in the last 50 years. Concepts of~     addiction have shifted from an early focus on tolerance and withdrawal to a current emphasis~     on the psychological components of dependence. Drug addiction has been redefined as drug~     dependence and standardized diagnostic criteria have been adopted for drug abuse, dependence~     and withdrawal. Psychometric testing methods have been developed, validated, and applied~     clinically for measurements of dependence, drug craving, and withdrawal for a wide variety of~     substances of abuse including cocaine, heroin, and amphetamine.~      Until recently, none of these addiction medicine metrics had been used to study the addiction~     potential of phentermine. Presumably, since phentermine is an amphetamine congener, any~     clinical characteristics of dependence or withdrawal should mimic those of amphetamine~     dependence or withdrawal. One recent retrospective study investigated symptoms occurring when~     patients treated with long-term phentermine in a weight management program abruptly ceased~     taking phentermine. The study found that patients on long-term phentermine who ceased~     phentermine abruptly by their choice did not have an amphetamine-like withdrawal symptom~     complex. Significantly there was no evidence of phentermine cravings. Further investigation~     is warranted.~      The addiction potential of a drug may be investigated by measuring the drug's propensity to~     induce dependence, to induce cravings for the drug, and for cessation of the drug to induce~     characteristic withdrawal symptoms. In the case of amphetamine withdrawal symptoms appear~     very quickly reaching a maximum at 48 hours after drug cessation.~      In this prospective study the addiction potential of phentermine will be assessed with~     validated psychometric scales to examine patients who have taken phentermine long-term for~     two years or more. Patients who have taken phentermine for 7 to 14 days will also be~     assessed. Participating patients who have taken phentermine long-term in this study will be~     asked to interrupt phentermine therapy for 48 hours to participate in the study. Scale~     examinations will be conducted at 24 and at 48 hours after drug cessation.~      Hypotheses~        1. Long-term phentermine-treated (LPT) patients do not develop phentermine dependence or~          cravings.~        2. LPT patients who cease taking phentermine abruptly do not experience amphetamine-like~          withdrawal symptoms.~      Specific Aims~        1. To compare the severity of phentermine dependence and craving between LPT patients and~          acute phentermine-treated (APT) patients~        2. To compare the severity of stimulant withdrawal symptoms before and after phentermine~          cessation in LPT patients.~        3. To examine the prevalence of phentermine dependence in LPT patients~   "
165267|NCT01402505|"~     This is a prospective chart review/data collection study of natural orifice translumenal~     endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires~     administered throughout the study. Subjects enrolled will be those intending to have a~     transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months~     post-op.~   "
165154|NCT01403987|"~     The investigators hypothesize that there is significant variability in management of patients~     with ascites despite guidelines provided by the American Association for the Study of Liver~     Diseases, the professional organization most involved with management of liver patients. This~     variability may be attributable to knowledge deficits, skill limitations, or reflect~     systems-issues that limit the ability of a care provider to implement the clinical guidelines~     (time constraints, inadequate supervision, availability of appropriate equipment, and~     obtaining consent for non-emergent procedures). This variability does a disservice to the~     patients being treated, and results in trainee development of habits that are not evidence~     based. There are simple teaching tools available that may improve learning and retention of~     evidence based practice. Using these tools should result in more consistent appropriate~     patient care, improve patient outcomes, and provide better education to our trainees.~      The purpose of this study is threefold: 1. To improve medical house-staff's technical~     performance of and comfort level with paracentesis; 2. To improve adherence to professional~     organization guidelines and to determine if this in fact improves clinical outcomes; 3. To~     evaluate efficacy of three teaching interventions in inpatient medicine trainee rotations.~   "
165155|NCT01403974|"~     This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated~     dose (MTD) or the relevant biological dose (RBD) in the absence if a MTD of a new drug BI~     836845 which blocks the insulin-like growth factor (IGF) pathway believed to be involved in~     cancer growth. BI 836845 will be administered for the very first time into cancer patients.~      The study will also look at the overall safety of the drug, and examine the drug levels in~     the body at specific timepoints during the trial (pharmacokinetic profile); the effect the~     drug may have on tumours will also be examined (pharmacodynamics).~   "
165156|NCT01403961|"~     The purpose of this study is to evaluate Hemoglobin A1c values previous to a surgery in~     patients with diabetes type II and the complication incidence in immediate post surgery.~   "
165157|NCT01403948|"~     The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability,~     pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or~     refractory non-Hodgkin lymphoma with at least prior treatments.~   "
165158|NCT01403935|"~     The purpose of this study is to create an institutional registry of sepsis through a~     prospective survey based on epidemiological data, risk factors, diagnosis, prognosis,~     treatment, monitoring and survival.~   "
165159|NCT01403922|"~     This is a two part study. Part 1 will determine determine if administration of TC-5214 has an~     effect on sitting blood pressure in patients with chronic hypertension.~      Part 2 will determine any possible interactions between TC-5214 and Anti-Hypertensive~     Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors).~   "
165160|NCT01403909|"~     The main objective of this study was to evaluate the effect of intermittent pneumatic venous~     compression on intra-operative fluid intake by comparing two groups of patients with or~     without intermittent pneumatic compression of the lower limbs.~   "
165161|NCT01403896|"~     Stem cells can be transplanted from a healthy donor to a patient to combat blood cancers and~     other disorders. This process is called stem cell transplantation. Stem cells normally live~     in the bone marrow. A bone marrow transplantation (BMT) is when the bone marrow is directly~     transplanted into a patient. However, stem cells can also be stimulated to move from the bone~     marrow to the blood where they can be collected, a process is called mobilization. When these~     stem cells are transplanted it is called peripheral blood stem cell transplantation (PBSCT).~     Both stem cell sources are used for different reasons, but PBSCT is much more common.~      There is considerable debate as to which stem cell source, BMT or PBSCT, is optimal. There~     are differences between the two sources in important transplant outcomes. The stem cell~     product that is transplanted, also called the stem cell graft, contains more than just stem~     cells. Results from studies suggest that the variation in the cells with grafts may account~     for the variation in outcomes. Preliminary data from a recent study conducted by the Canadian~     Blood and Bone Marrow Transplant Group has associated relative frequencies of particular cell~     populations with leukemic relapse and another important outcome called graft versus host~     disease (GVHD). While the later essentially equates to a failed transplant, the former is the~     most common and devastating complication of stem cell transplantation.~      The only drug used to mobilize stem cells into the blood of health donors for collection is~     G-CSF. However there is a new mobilization drug recently approved called plerixafor. This~     drug is able to mobilize stem cells when G-CSF has failed and pre-clinical studies suggest~     that it may produce a superior stem cell graft to G-CSF alone. There is little information~     available, besides safety and efficacy data, about the effects that plerixafor has on the~     stem cell graft of normal healthy donors.~      This study will compare the stem cell graft in normal healthy donors following plerixafor~     mobilization versus plerixafor and G-CSF mobilization. Specifically, they will look at the~     cell populations that have been previously correlated with important transplantation outcomes~     like relapse and GVHD. The investigators suspect that the stem cell graft mobilized by~     plerixafor and G-CSF will provide a superior graft to that mobilized by plerixafor alone.~   "
165162|NCT01403883|"~     In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of~     postoperative anastomotic leakage. The aim of the study was to assess the benefit of an~     optimal care, i.e., both psychological and enterostomal therapy care.~   "
165163|NCT01403870|"~     The purpose of this research study is:~        1. to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal~          Regions) the electrical signals made by the muscles in the lower back during the~          treatment of the low back pain, and~        2. to study the changes which take place in these muscles with treatment. The device is~          non-invasive which means nothing is put into your body. The CERSR® pad is an adhesive~          (sticky) array (ordered rows) of electrodes.~      The investigators hope to find information about the quality of the muscles' electrical~     signals in reaction to injury causing back pain, which will improve understanding of the~     nature of back pain and back injury. The investigators also hope to improve treatment by~     creating a simple test, which will tell us objectively (through computerized measurement)~     whether the treatment is helping.~   "
165164|NCT01403857|"~     The specific aims of the Grain Study are to determine if sensitivity to bitter taste affects~     the liking and acceptability of different grain products, to determine if exposure to~     different types of grain products, over a period of 6 weeks, changes liking and acceptability~     and to determine if the gut microbiota, bacterial fermentation products, or gastrointestinal~     function changes with consumption of whole grains or refined grains.~   "
165165|NCT01403844|"~     The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy~     for assessing vegetable and fruit consumption.~   "
165166|NCT01403831|"~     The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to~     Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a~     technologically simple solution using unidirectional daily text messages to consisting of~     educational materials, trivia questions and challenges promoting healthy lifestyle choices~     and reminders to check blood sugar, take medications and go to clinic appointments. The~     investigators believe TExT-MED will improve health outcomes including blood glucose control~     and encourage weight loss, healthy eating and exercise. TExT-MED is low cost, easy to use and~     can be quickly adapted to other practice environments.~   "
165170|NCT01403779|"~     Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and~     normofractionated radiotherapy after breast-conserving surgery. However, the treatment in~     these studies was carried out with conventional techniques and not with the modern IMRT. Also~     the evaluation of quality of life and cosmetic outcome were not standardized.~      This study is a two-arm prospective study comparing normofractionated and hypofractionated~     radiotherapy in patients with breast cancer using tangential IMRT techniques.~      The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint~     is the patients' quality of life.~      Patients to be included are breast cancer 60 years old patients or older with tumour stages~     pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast~     cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15~     fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25~     fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).~      In both groups, a tangential intensity-modulated radiation technique aiming to achieve~     optimal dose homogeneity is applied.~      Since higher single radiation dose to the heart can lead to higher morbidity and/or~     mortality, patient stratification according to the diseased side was adopted where the~     left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore~     there is no randomization.~      For classification and grading of adverse cosmetic events, the Common Toxicity Criteria~     (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of~     life is to be documented with two standardized, validated questionnaires QLQ C30 and BR23~     of the EORTC (European Organization for Research and Treatment of Cancer). The questionnaires~     are to be filled by the patients themselves at different time points during the study period.~      A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of~     around 20% is expected after 2 years.~      Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power~     of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the need~     for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated therapy).~   "
165171|NCT01403766|"~     Glomerular filtration rate (GFR) is the best known measurement of kidney function. Serum~     creatinine (blood test) is the most commonly used marker to predict GFR. It is a convenient,~     inexpensive test that involves a single blood draw with rapid results. However, creatinine~     has several limitations because its blood level is dependent on age, body mass, and sex. One~     of the gold standards for measuring GFR is plasma clearance of an IV injected agent, iohexol.~     It has been found to be safe and nontoxic in prior studies, but is not practical in the~     clinical setting due to the need for several timed blood draws. Recent studies have~     investigated the use of cystatin C as an alternative marker to predict GFR. Cystatin C also~     involves only a single blood draw, and has less confounding factors than creatinine since it~     is independent of age, body mass, and sex. Currently, it remains controversial whether~     cystatin C is a significantly better biomarker of estimated GFR than creatinine. To date,~     there has not been a large prospective cohort study to compare cystatin C and creatinine in~     pediatric kidney transplant patients who are on maintenance immunosuppression (anti-rejection~     drugs). Accurate measurement and early detection of deterioration of GFR is critical in the~     care of this patient population. The purpose of this study is to assess the accuracy of~     estimating GFR by using cystatin C versus creatinine clearance equations when compared to the~     surrogate gold standard of iohexol GFR in pediatric renal transplant patients.~   "
165172|NCT01403753|"~     The purpose of this study was to measure and quantify children's beliefs about the satiating~     properties (i.e. expected satiation)of snack foods. The investigators predicted that children~     who were especially familiar with snack foods would expect them to deliver greater satiation.~   "
165173|NCT01403740|"~     Turkish Acquired Haemophilia Registry is a database in which information about clinical~     features and therapeutic management of acquired haemophilia is collected in Turkey.This is a~     multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for~     acquired haemophilia. Patients will be registered and the response to different therapies,~     details of each bleeding episode and the outcome of haemostatic and immunosuppressive therapy~     (IST) will be recorded. Any male or female subject diagnosed with inhibitors to FVIII or~     other factors and treated for acquired haemophilia can be entered on the registry. Patients~     will be treated according to local practice. No additional tests or procedures are required~     by the registry. The retrospective period will not be time-limited and data will be collected~     from those recorded in the hospital notes. The prospective period will begin in September~     1.2011, and will last for two years.~   "
165174|NCT01403727|"~     The purpose of the trial is to evaluate the differences between PercuNav assisted and~     unassisted biopsy in the areas of CT radiation dose, procedure time and biopsy accuracy.~      This prospective, randomized, controlled trial will compare the use of electromagnetic~     tracking and image guidance (CT) during biopsy procedures verses the typical CT image guided~     procedure alone.~   "
165175|NCT01403714|"~     This study will address the role of percutaneous renal intervention for a hemodynamically~     significant renal artery stenosis in patients with heart failure exacerbations. Current~     guidelines suggest evaluation for renal artery stenosis in patients with pulmonary edema or~     heart failure that cannot be attributed to poor left ventricular function. While case series~     have suggested benefit to percutaneous intervention in patients with heart failure, no~     randomized study has addressed the potential benefit of renal stenting for heart failure~     patients. Two large randomized trial of renal stenting for hypertension or poor kidney~     function failed to show benefit in patients with intermediate renal artery lesions. No~     evaluation of the potential hemodynamic significance of the lesions was performed prior to~     randomization. The investigators will enroll patients with heart failure exacerbations not~     attributable to declining left ventricular function, valvular disease, acute coronary~     syndrome, or heart transplant rejection, who on non-invasive imaging appear to have renal~     artery stenosis. After routine invasive assessment, including renal angiography and~     pressure-wire assessment, patients with hemodynamically significant renal artery stenoses~     will be randomized to stent implantation or medical therapy. Patients will then be followed~     to determine whether stenting impacts cardiac mortality or hospitalization for heart failure.~   "
165176|NCT01403701|"~     i) The primary objective of this study is to determine if physical therapy improves~     postoperative quality of life in participants following vaginal reconstructive surgery for~     pelvic organ prolapse and urinary incontinence.~      ii) Secondary objectives include:~        1. Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse~          symptoms) in participants undergoing physical therapy compared to standard postoperative~          care~        2. Comparing sexual function in participants undergoing physical therapy compared to~          standard postoperative care;~        3. Comparing postoperative pain scales, and activity assessment in participants undergoing~          physical therapy compared to standard postoperative care;~        4. Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in~          participants undergoing physical therapy compared to standard postoperative care.~   "
165268|NCT01402492|"~     The aim of this study is to investigate the safety and effectiveness of buprenorphine in the~     presence of naltrexone for the treatment of cocaine dependence.~   "
165177|NCT01403688|"~     Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from~     infertility treatments may increase breast cancer risk, but there has not been enough~     research to know for sure. Researchers want to use a method of taking breast tissue cells~     from women who are having infertility treatment. The breast tissue cells might show changes~     that would indicate an increased risk of cancer. The method of taking the breast tissue cells~     is called Fine Needle Aspiration (FNA).~      The purpose of this study is to examine the changes in breast tissue, in women at high risk~     of breast cancer who are being treated with controlled ovarian hyperstimulation.~   "
165178|NCT01403675|"~     Chemotherapy can cause permanent damage to a woman's ovaries. Women who are cancer survivors~     may find that they are not able to produce female hormones, and they may not be able to have~     a child. Scientists are trying to find ways to help cancer survivors regain their hormonal~     function and possibly get pregnant, if they desire. Scientists have developed a method where~     ovarian tissue is removed and frozen before chemotherapy; then it is thawed and put back into~     the woman's body after she is cancer-free. Putting a woman's previously-frozen tissue back~     into her body is called ovarian autotransplantation.~      Ovarian autotransplantation is a very new technique, and there have only been a small number~     of women who have had this procedure. So far, only five babies in the world have been born~     using this technique.~      The purpose of this study is to learn more about ovarian autotransplantation. Scientists hope~     to find better ways to use this method to help a woman's ovaries start working again after~     chemotherapy. If the ovaries start working again, it might be possible to have a baby.~   "
165179|NCT01403662|"~     Long-term studies have emphasized that depressive symptoms and episodes account for majority~     of the illness burden experienced by individuals with bipolar disorder (BD). Previous studies~     have shown that blood levels of proteins called pro-inflammatory cytokines are abnormal in~     individuals with bipolar depression. The investigators hypothesize that preventing the~     production or release of pro-inflammatory cytokines will result in improvement of depressive~     symptoms in individuals with bipolar depression. Minocycline is a medication that inhibits~     the activation of immune cells (i.e. microglia) in the brain and reduces the production of~     pro-inflammatory cytokines. Treatment with minocycline has been shown to have~     antidepressant-like effects in animal studies and improve symptoms of individuals with~     schizophrenia. In this study, minocycline (100 mg twice a day) will be administered for 8~     weeks to determine if it is an efficacious antidepressant for individuals with bipolar~     depression.~   "
165180|NCT01403649|"~     Beginning with the 2009-2010 season, influenza vaccine is universally recommended for~     children age 6 months to 18 years old, placing extra burden on health care providers across~     the U.S. The focus of this study is to develop new strategies and implement existing~     evidence-based strategies to enhance influenza immunization in these children. The~     intervention will involve collaboration from different types of primary care providers, the~     Colorado Immunization Information System (CIIS), public health departments and visiting~     nursing services (VNA). It will be designed and implemented by those involved with delivery~     with a focus on sustainability after the completion of the study. Parental input will be~     gathered during the planning year through focus groups to assist in developing the~     intervention. Qualitative assessments and examination of processes during the first year of~     implementation will guide modifications during the second implementation year in order to~     assure sustainability. Primary outcome measures in the intervention and control groups: 1)~     increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year~     compared to the pre-intervention year among children 6 mo.-18 yr. and 2) increase in the rate~     of children 6 mo.-18 yr. who were fully immunized (received all required influenza~     injections) during the season. 3) measure outcomes by age group (6 mo.-5 yr., 6-8 yr., 9-12~     yr., 13-18 yr.) and types of clinical sites (urban Peds, urban FM, rural FM)~   "
165181|NCT01403636|"~     Primary Objective:~      - To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in~     patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle~     cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small~     lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)~      Secondary Objectives:~        -  To assess duration of response, progression free survival (PFS), and proportion of~          patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or~          DLBCL treated with SAR245409~        -  To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL~          or DLBCL~        -  To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with~          MCL, FL, CLL/SLL or DLBCL~   "
165182|NCT01403623|"~     The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared~     to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing~     hyperthermia (> 37.5 degrees C).~   "
165183|NCT01403610|"~     The Primary Objectives are:~        -  To determine the extent by which TH-302 is able to penetrate the blood brain barrier and~          affect tumor tissue~        -  To assess the safety of single dose TH-302 in patients with high grade glioma undergoing~          surgery~        -  To assess the safety of TH-302 in combination with bevacizumab for patients with high~          grade glioma~        -  To determine the MTD and DLT(s) of TH-302 in combination with bevacizumab~      The Secondary Objectives are:~      To determine the progression-free survival with or without debulking craniotomy for patients~     treated with combination bevacizumab and TH-302 following recurrence on single agent~     bevacizumab~   "
165184|NCT01403597|"~     The study is designed to determine the safety, efficacy, patient comfort and patient~     satisfaction of the combined treatment of Refirme ST and Matrix RF both devices approved~     under 510k clearances. The evaluations will include skin condition, physician/subject~     improvement assessment, and subject comfort and satisfaction score by questionnaires.~   "
165196|NCT01403428|"~     Status Asthmaticus is recognized as a common cause of morbidity in children in the United~     States (CDC). In recent years, hospitalization rates have reached an all time high. This~     study will evaluate the effect of early use of noninvasive positive pressure ventilation~     (NPPV) in children admitted to the pediatric intensive care unit (PICU) with moderate to~     moderately severe status asthmaticus to test the hypothesis that early initiation of NPPV~     plus standard of care will result in decreased length of PICU stay, significant improvement~     in clinical asthma score (CAS) and reduced patient care costs when compared to standard of~     care alone.~   "
165185|NCT01403571|"~     Canadian statistics indicate that the incidence of obesity is increasing and that the~     occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy~     weight, making weight control in this population particularly relevant. Preliminary clinical~     data has shown that the whole grain, Salba, may improve type 2 diabetes control, reduce~     after-meal blood glucose, cardiovascular disease (CVD) risk factors and suppress appetite.~     Its use may therefore have potential implications in long-term weight management, while~     improving diabetes.~      The objective of this research (weight loss) is to evaluate whether adding Salba to an energy~     reduced diet for six months will result in greater weight loss compared to control in~     overweight and obese individuals with type 2 diabetes. The study recruited 77 overweight or~     obese individuals with type 2 diabetes. They were instructed to follow a calorie restricted~     diet and their regular diabetes therapy together with regular exercise. Participants were~     randomly assigned to receive 30 g Salba/1000 kcal of daily energy requirements, or an oat~     bran control supplement matched for energy. The effect of the supplements on weight-loss~     (including waist circumference, % body fat) and glucose control (A1c, fasting glucose levels)~     will be assessed. In addition, related outcomes such as low-grade body inflammation,~     hunger-regulating hormones (ghrelin, adiponectin), safety measures (urea, creatinine, ALT and~     prothrombin time) and satiety scores were evaluated.~      Modest weight loss has been associated with improved glucose control in individuals with type~     2 diabetes. Addition of Salba to an energy reduced diet may facilitate greater weight loss~     and improve glycemic control and CVD risk factors compared to such a diet alone. Salba may~     also promote maintenance of weight loss and therefore help prevent weight gain by providing~     feelings of fullness that reduce appetite. In light of the high incidence of obesity in~     individuals with diabetes, Salba grain may be a useful addition to the diet.~   "
165186|NCT01403558|"~     The aim of this randomized controlled trial is assess the effect of a psychological based~     treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese~     patients undergoing bariatric surgery.~      Hypothesis: As compared with usual care, Cognitive Behavioral Therapy and Motivational~     interviewing-based (CBT/MI) intervention program will reduce dysfunctional eating behaviors~     and increase pre-surgical intrinsic motivation for lifestyle changes.~   "
165187|NCT01403545|"~     Aim of the present study is:~        -  To evaluate the safety and tolerability of increasing doses of intravenous liposomal~          Curcumin in healthy subjects by means of adverse events, vital signs and safety~          laboratory assessments.~        -  To investigate the pharmacokinetics of increasing doses of intravenous liposomal~          Curcumin in healthy subjects.~   "
165188|NCT01403532|"~     The traditional therapy for induction of spermatogenesis in male hypogonadotropic~     hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy~     occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the~     investigators raise a new sequential therapeutic approach which can make the treatment more~     economic and tolerable. The zinc supplement will be also evaluated in patients in this study.~     This randomized, parallel, open, and multi-center study will compare the efficacy of~     traditional therapy with new therapy and evaluate the safety of the new protocol.~   "
165189|NCT01403519|"~     Tau pathology and tangles have been associated with cognitive dysfunction causing~     neurodegeneration. AD, the most abundant tauopathy is characterized by amyloid plaques and~     tau tangles. An abundance of tau inclusions, in the absence of amyloid deposits, defines~     Pick's disease (frontotemporal lobar degeneration), progressive supranuclear palsy (PSP),~     corticobasal degeneration (CBD) and other diseases including frontal atrophy associated with~     cognitive clinical dysfunction of frontal dysexecutive syndrome, progressive nonfluent~     aphasia and semantic dementia as recently reviewed (Gozes 2010). It is the investigators aim~     to follow other protein expression [as per recent publications (Marksteiner et al., 2011)] in~     blood and CSF samples from those tauopathies.~      Significance: Results should establish the possibility of using tau and other proteins as~     markers for early detection and disease progression in FTD, also in comparison to Alzheimer's~     disease (AD).~   "
165190|NCT01403506|"~     The purpose of this study is to investigate the effect of (NAC) N-Acetyl Cysteine on~     biomarkers of Delayed Graft Function (DGF), including Neutrophil Gelatinase Associated~     Lipocalin (NGAL) and Intereleukin 18 (IL18).~   "
165191|NCT01403493|"~     In this randomized controlled study in patients with irritable bowel syndrome (IBS), the~     investigators plan to compare the effects of a multidisciplinary structured patient group~     education with a compressed nurse based structured patient group education. The effects of~     the interventions on gastrointestinal (GI) and psychological symptom severity, knowledge and~     quality of life will be assessed with validated questionnaires at baseline and 3, 6 and 12~     months after the intervention.~   "
165192|NCT01403480|"~     Basal Cell Carcinoma (BCC) is the most common malignant growth in the world. Treatment is~     primarily surgical with the goal of excising the growth in its entirety. When pathology~     results show that this has not been achieved, a re-excision is routinely performed. This~     study examines retrospectively the percentage of re-excisions of BCC that actually proved to~     be positive (exhibited growth) among those re-excisions performed at Rambam Healthcare Campus~     and Zvulun Community Medical Center during the years 2008-10.~   "
165193|NCT01403467|"~     This current study aimed to demonstrate the effectiveness of the addition of CPAP to the~     current conventional therapy in terms of airway obstruction improvement in acute asthma~     patients.~   "
165194|NCT01403454|"~     This study involves Chronic Kidney Disease patients that must choose the type of dialysis~     therapy they ultimately wish to perform. These patients receive education regarding dialysis~     types from nurses and Nephrologists at a Kidney Function Program. The investigators have~     developed a web-based Interactive Health Communication Application that could provide more~     education and support to patients about their dialysis choices. The investigators will~     compare patients that will receive usual care dialysis education versus patients that will~     receive additional education through this web-based application. The investigators feel that~     this tool may increase the proportion of patients who start home dialysis, which offers~     advantages such as improvement in quality of life and deceased overall healthcare costs, over~     hospital hemodialysis.~   "
165195|NCT01403441|"~     This study is designed to evaluate the safety and effectiveness of an investigational~     procedure for treating people with treatment resistant bipolar depression (TRD). Precise dose~     delivery of radiation to the predetermined targets in the brain will be accomplished with~     known Cyberknife stereotactic radiosurgery methods. This technology is considered to be~     noninvasive (does not physically invade your body). We will be studying if the Cyberknife~     influences the sensitivity of certain nerves of your brain. Although many clinical treatments~     for psychiatric conditions have been done using stereotactic radiosurgery, the present study~     is experimental, because we are seeking to use more moderate doses of radiation that are~     intended not to destroy any brain cells, but to normalize or modulate their function.~   "
165197|NCT01403415|"~     This phase I trial studies the side effects and the best dose of temsirolimus when given~     together with dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and~     pegaspargase in treating young patients with relapsed acute lymphoblastic leukemia or~     non-Hodgkin lymphoma. Temsirolimus may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone,~     mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving temsirolimus with combination chemotherapy may be and effective treatment~     for acute lymphoblastic leukemia or non-Hodgkin lymphoma.~   "
165198|NCT01403402|"~     The Congenital Muscle Disease Patient and Proxy Reported Outcome Study (CMDPROS) is a~     longitudinal 10 year study to identify and trend care parameters, adverse events in the~     congenital muscle diseases using the Congenital Muscle Disease International Registry (CMDIR)~     to acquire necessary data for adverse event calculations (intake survey and medical records~     curation). To support this study and become a participant, we ask that you register in the~     CMDIR. You can do this by visiting www.cmdir.org. There is no travel required.~      The registry includes affected individuals with congenital muscular dystrophy, congenital~     myopathy, and congenital myasthenic syndrome and registers through the late onset spectrum~     for these disease groups. The CMDIR was created to identify the global congenital muscle~     disease population for the purpose of raising awareness, standards of care, clinical trials~     and in the future a treatment or cure. Simply put, we will not be successful in finding a~     treatment or cure unless we know who the affected individuals are, what the diagnosis is and~     how the disease is affecting the individual.~      Registering in the CMDIR means that you will enter demographic information and complete an~     intake survey. We would then ask that you provide records regarding the diagnosis and~     treatment of CMD, including genetic testing, muscle biopsy, pulmonary function testing, sleep~     studies, clinic visit notes, and hospital discharge summaries.~      Study hypothesis:~        1. To use patient and proxy reported survey answers and medical reports to build a~          longitudinal care and outcomes database across the congenital muscle diseases.~        2. To generate congenital muscle disease subtype specific adverse event rates and correlate~          with key care parameters.~   "
165199|NCT01403389|"~     The purpose of this study is to determine if Eculizumab is safe and effective in the~     prevention of delayed graft function following deceased donor kidney transplantation.~   "
165200|NCT01403376|"~     Primary Objective:~      Assess the antibody response to influenza vaccine in patients with relapsing form of multiple~     sclerosis (RMS) treated with teriflunomide compared to a reference population.~      Secondary Objectives:~        -  Assess the effect of teriflunomide on immunoglobulin levels;~        -  Assess the safety of influenza vaccination in patients with RMS treated with~          teriflunomide.~      The reference population was defined as multiple sclerosis (MS) patients with a stable~     treatment with interferon-β-1. Antibody response was measured using hemagglutination~     inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1,~     and B as present in the influenza vaccine used.~   "
165201|NCT01403363|"~     Fentanyl is considered a potent synthetic opioid widely used in anesthesiology, for short and~     long-term pain management, and for sedation. The fentanyl patch is constructed like a matrix,~     a system based on a polyacrylate net with fentanyl that attaches directly onto the skin. The~     doses available today are from 12µg/h, 25, 50, 75, to 100 µg/h. Despite the variable doses~     available, often in certain patients as the elderly or children, there is a need for slower~     titration than the 12 µg/h currently available.~      In this study, the investigators aim to evaluate pain control and to examine the blood~     fentanyl concentration of patients on a fix dose of fentanyl patch up to 100 µg/h every two~     or three days, and compare it with pain control and concentration levels obtained from a~     similar dose patch, but after cutting the patch into two.~      The study will take place at the pain clinic of Clalit Health Services-South District~     (CHS-SD), and the Negev home palliative care unit. In CHS-SD there are approximately 300~     patients treated regularly with opioids and about 120 patients in the home palliative care~     unit. A sample of 95 patients will be recruited. Once consent form is signed, blood samples~     will be collected twice: 1. At the time of the visit; 2. After 144 hours (about 6 days) from~     the first sample, and at least 36 hours after replacing the cut patch. Pain management will~     be evaluated at both visits using the Brief Pain Inventory (Hebrew version) - BPI~     questionnaire, and rescue doses used before and after the cutting of the patch. The blood~     samples will be transferred to the laboratory for testing of fentanyl concentration levels.~   "
165202|NCT01403350|"~     Malaria is a common, but decreasing, cause of fever in endemic areas. The use of rapid~     diagnostic tests could improve treatment of malaria at the local community level. Deployment~     of these tests is, however, a considerable cost. The aim of the study is to evaluate their~     effect on improving treatment of fever when used by Community Health Workers in Afghanistan.~     In phase I of the study, the hypothesis is that an RDT diagnosis deployed with standard~     training and support will improve the accuracy of treatment applied to fever by community~     health workers when compared to a diagnosis that is based on symptoms alone. In Phase II of~     the study, the hypothesis is that the accuracy of treatment can be improved by additional~     training and supportive interventions given to community health workers compared to those who~     have only had standard training.~   "
165203|NCT01403337|"~     Vascular surgery is considered a high-risk operation with an anticipated risk of major~     cardiovascular complications in excess of 5%. The occurrence of a cardiovascular complication~     after surgery carries a long-term higher mortality risk. The main objective of this~     investigation is to reduce the proportion of patients having major cardiovascular~     complications during surgery through a clinical protocol of remote preconditioning that is~     safe, effective and reproducible.~   "
165204|NCT01403324|"~     Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131~     administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to~     treat patients with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the~     pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels is~     to perform intramuscular injection of recombinant human TSH, a hormone produced~     pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the~     metastases is similar after rhTSH administration or after thyroid hormone withdrawal.~   "
165207|NCT01403285|"~     BACKGROUND: Active immunotherapy of cancer is based on the premise that the vaccine raises a~     cytotoxic immune response to tumor-associated antigens, thereby destroying malignant cells~     without harming normal cells.~      IMA950 is a therapeutic multi-peptide vaccine containing 11 tumor-associated peptides~     (TUMAPs) found in a majority of glioblastomas, and is designed to activate TUMAP-specific T~     cells. The use of 11 TUMAPs increases the likelihood of a multi-clonal, highly specific~     T-cell response against tumor cells leading to decreased likelihood of immune evasion of the~     tumor by down-regulation of target antigens.~      PURPOSE: The primary objective of this study is to determine the safety and tolerability of~     IMA950 when given with cyclophosphamide, granulocyte macrophage-colony stimulating factor~     (GM-CSF) and imiquimod in patients with glioblastoma and to determine if IMA950 shows~     sufficient immunogenicity in these patients.~      ELIGIBILITY: Patients with histologically proven GBMs who have completed radiotherapy, and~     have stable disease following at least 4 cycles of adjuvant temozolomide.~   "
165208|NCT01403272|"~     The primary purpose of this research study is to evaluate if DermaTherapy® bedding will~     significantly reduce pressure ulcer incidence by decreasing maceration, friction, and~     shearing among residents of Nursing Homes.~   "
165209|NCT01403259|"~     The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus~     oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal~     carcinoma.~   "
165210|NCT01403246|"~     This is a phase I-II multicenter, open label study in previously untreated and elderly~     patients (> 60 years) with CLL ,which includes 2 sections:~      Induction phase with Chlorambucil and Lenalidomide (CL):~        -  Phase 1: a non-comparative phase aimed at defining the MTD of lenalidomide given in~          combination with chlorambucil and the efficacy and safety of the lenalidomide and~          chlorambucil combination;~        -  Phase 2: a non-comparative phase aimed at defining the overall response rate of~          lenalidomide given at the MTD in combination with chlorambucil.~      Maintenance versus clinical observation:~      -A comparative phase including lenalidomide or clinical observation aimed at defining the~     benefit of lenalidomide given as maintenance therapy.~   "
165211|NCT01403233|"~     The purpose of the study is to examine the bioavailability of cogniVida™ in 10 healthy male~     subjects after consumption of two different doses of cogniVida™ (50 mg and 100 mg) and to~     compare the plasma values with values obtained in subjects receiving rebaudioside A (303.68~     mg). In addition, also safety and tolerability parameters 24 hours after ingestion of the~     study compounds will be determined.~      cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by~     the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug~     Administration does not strictly regulate herbs and dietary supplements. The investigators do~     not claim that this supplement is meant to treat any ailment.~   "
165212|NCT01403220|"~     The primary objective of this study is to compare the efficacity of hemodiafiltration and~     hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary~     objectives include comparing urea clearance, filter duration, and %down-time, between the two~     techniques.~   "
165213|NCT01403207|"~     This pilot study will use tissues and fluids that are normally discarded during the course of~     total knee replacement surgery to investigate potential sex differences in knee~     osteoarthritis. Basic clinical demographic information will be obtained as well as~     preoperative functional and pain assessment scores, functional tests, and pressure pain~     threshold measurement. The purpose of the study will be to investigate if any sex differences~     can be identified in these tissues and to investigate if there appears to be any relationship~     between these differences and functional scores and tests.~   "
165214|NCT01403194|"~     The hypothesis for this study is that children with sleep disordered breathing will benefit~     from treatment with Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway~     Pressure (BiPAP) in terms of reduction in cardiovascular risk markers and insulin resistance.~      The CPAP machine delivers a predetermined level of pressure. It releases a stream of~     compressed air through a hose to the nose mask and keeps the upper airway open under~     continuous air pressure. This air pressure prevents obstructive sleep apnea, which occurs as~     a result of narrowing of the airway due to the relaxation of upper respiratory tract muscles~     during sleep. This machine helps to increase the oxygen flow by keeping the airway open.~      The BiPAP machine delivers two levels of pressure. Inspiratory Positive Airway Pressure~     (IPAP) is a high amount of pressure, applied when the patient inhales and a low Expiratory~     Positive Airway Pressure (EPAP) during exhalation.~   "
165215|NCT01403181|"~     Analysis of HCV-specific T cell responses in patients treated with boceprevir to assess~     whether therapy can induce restoration of the T cell function and to what extent this~     recovery can be achieved~   "
165216|NCT01403168|"~     This is an open, prospective, controlled, randomized, comparative study with 2 arms.~      The purpose of the study is to assess the efficacy of osteopathy after breast surgery.~      80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will~     be followed during one year.~   "
165217|NCT01403155|"~     DNA vaccines consist of small pieces of DNA also known as plasmids, and have several~     potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well~     tolerated in humans. The investigators have developed a DNA vaccine, INO-3401, which includes~     plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will be~     delivered via electroporation (EP) which uses the CELLECTRA constant current device to~     deliver a small electric charge following injection, since animal studies have shown that~     this delivery method increases the immune response to vaccine. The vaccine will be given to~     up 30 healthy adult subjects who have participated in study FLU-001. It is hypothesized that~     a booster dose with INO-3401 + EP will be well tolerated and immunogenic.~   "
165263|NCT01402557|"~     Obesity can cause many health problems, including high blood pressure, diabetes, heart~     disease, and stroke. Although some people may lose weight through diet and exercise, many~     regain weight over time. There is a need to study new ways of helping people maintain their~     weight. The purpose of this research is to study the effect of a weight maintenance program~     provided through home television sets connected to the Internet.~   "
165264|NCT01402544|"~     To determine if patients treated early after diagnosis of wet age-related macular~     degeneration can return/maintain to their baseline pre-disease BCVA.~   "
165218|NCT01403142|"~     Cardiac allograft vasculopathy (CAV) is a unique form of accelerated plaque formation seen in~     the coronary arteries of patients who have received heart transplantation. It is a major~     cause of morbidity and mortality in patients after heart transplant. Little progress has been~     made in characterizing this disease process, with more sophisticated imaging allowing for~     more detailed analysis of CAV, superior stratification of transplant recipients is possible~     and earlier interventions can be performed if necessary to prevent mortality and graft loss.~      Optical Coherence Tomography (OCT) is a novel imaging modality with much higher resolution~     then Intra-Vascular Ultrasound (IVUS). This study will involve examining patients post-heart~     transplant using this high-resolution imaging modality. It is currently the standard care for~     patients post-heart transplant to receive annual coronary angiograms with close follow up.~     Patients will be imaged using OCT at the time of their routine annual angiogram, and will be~     re-imaged one year later at the time of the next annual angiogram or earlier if clinically~     indicated. The study goal is to better characterize CAV in vivo with OCT imaging and to try~     to identify patterns of the disease, including intra-coronary risk assessment.~   "
165219|NCT01403129|"~     Keratoconus (KC) is a corneal disease which will in many cases ultimately require corneal~     transplantation to maintain vision. Early detection, which is not possible with current~     technology, would allow early treatment and prevent severe damage to KC corneas inadvertently~     operated upon for correction of vision. Our aim is to combine measurements of different~     properties of the cornea to develop means for early detection of KC.~   "
165220|NCT01403116|"~     The purpose of this study is to determine the safety and efficacy of an oral testosterone~     undecanoate formulation for use as testosterone-replacement therapy in men with low~     testosterone.~   "
165221|NCT01403103|"~     This pilot clinical trial studies cholecalciferol in treating patients with colorectal~     cancer. The use of cholecalciferol may slow disease progression in patients with colorectal~     cancer.~   "
165222|NCT01403090|"~     The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central~     line catheter. The device is designed to be placed in the inferior vena cava via the femoral~     vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous~     system. The primary endpoint is freedom from serious adverse events (SAE), defined as death,~     symptomatic pulmonary embolism or major bleeding .~   "
165223|NCT01403077|"~     This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the~     treatment of subjects with de novo native superficial femoral artery lesions.~   "
165224|NCT01403064|"~     The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the~     course of oral mucositis in subjects with head and neck cancer receiving concomitant~     chemotherapy and radiotherapy~   "
165225|NCT01403051|"~     This study was done with people who were infected with HIV and needed to start treatment for~     their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will~     help prevent the bone loss that sometimes happens when people start HIV treatment. For this~     study, the following HIV treatment (or HAART) were provided in the form of a single tablet~     that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These~     drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common~     for people who are taking HIV drugs for the first time. The risks seen with this HIV~     treatment are the same that you would encounter when taking these drugs outside of the study.~     The lists of risks of this HIV treatment are included in this document because the drugs are~     provided by the study, not because the drugs are being tested. The purpose of the study is~     only to look at the impact of high doses of vitamin D and calcium in preventing bone loss.~     There are no study objectives related to HIV treatment (EFV/FTC/TDF).~   "
165226|NCT01403038|"~     This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects~     of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve~     and to assess the effect of elagolix on selected endocrine/hormone levels.~   "
165227|NCT01403025|"~     This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and~     type of SADRs (serious adverse drug reactions).~   "
165228|NCT01403012|"~     Metabolomics of systemic psoriasis treatment~   "
165229|NCT01402999|"~     This is a Hungarian, Multicentre, Observational Study to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth~     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.~   "
165230|NCT01402986|"~     The purpose of this study is to determine whether the addition of tralokinumab to standard~     asthma medication is effective in the treatment of adults with asthma.~   "
165231|NCT01402973|"~     The purpose of this pilot study is to determine whether it is feasible to conduct a~     randomized, controlled dietary intervention trial of high versus low dietary intake of~     advanced glycation end products (AGEs) in 24 adults; and to gather preliminary data on the~     impact of high versus low AGE diet health parameters. The investigators hypothesize that it~     will be feasible to conduct a randomized, parallel arm, controlled dietary intervention in a~     pilot study involving 24 subjects.~   "
165232|NCT01402960|"~     The purpose of this study is to assess the effects of high-definition transcranial direct~     current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The~     investigators hypothesize that subjects will show a decrease in pain symptoms in the active~     anodal stimulation group when compared to sham stimulation.~   "
165233|NCT01402947|"~     This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR~     administered alone & in combination with MMX Mesalazine/mesalamine.~   "
165234|NCT01402934|"~     The investigators hypothesized that pulse pressure variation (PPV) could predict fluid~     responsiveness in spontaneously breathing patients undergoing anesthesia induction.~   "
165265|NCT01402531|"~     This is a research study to find out more about the use of Avastin (proper chemical name is~     bevacizumab) in the treatment of epistaxis (nose bleeding) in patients with Hereditary~     Hemorrhagic Telangiectasia (HHT).~   "
165266|NCT01402518|"~     This is a prospective chart review/data collection study of the per oral endoscopic myotomy~     (POEM) procedure, that will include questionnaires administered throughout the study.~     Subjects enrolled will be those intending to have a POEM procedure. Data will be collected~     and reviewed through 12 months post-op.~   "
165235|NCT01402921|"~     Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous~     insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on~     studies carried prior to CEAP classification (2004). Item C3 of this classification relates~     to patients suffering from chronic venous disease and permanent oedema. Literature mentions~     only one study in which volume reduction in venous-induced oedema was primary endpoint.~     Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a Class 2~     compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible quantitative~     measure considered nowadays as being gold standard when objectifying oedema variation. It is~     therefore particularly relevant in a C3-patient trial (CEAP classification).~      The main objective of the current study is to evaluate the clinical effect of Progressiv' MCT~     on volume reduction in permanent CVI-oedema after 3 months of treatment.~   "
165236|NCT01402908|"~     The purpose of this study is to determine if PI-88 is effective and safe in patients who have~     had surgery to remove primary liver cancer.~   "
165237|NCT01402895|"~     The purpose of this study is to determine if a certain treatment for low back pain can change~     the way nerves in the leg send messages. Specifically, the investigators will examine whether~     a particular type of physical therapy treatment for individuals with low back pain~     (neurodynamic techniques) changes the speed that nerves send/receive signals to/from the leg,~     as compared to a different physical therapy treatment.~   "
165238|NCT01402882|"~     The CRASH-3 trial will provide reliable evidence about the effect of tranexamic acid on~     mortality and disability in patients with traumatic brain injury. The effect of tranexamic~     acid on the risk of vascular occlusive events and seizures will also be assessed.~     Additionally, a nested study will be conducted in a subset of CRASH-3 trial participants.~     This nested study (CRASH-3 Intracranial Bleeding Sub-Study [CRASH-3 IBS]) will examine the~     effect of tranexamic acid on intracranial haemorrhage and cerebral ischaemia using CT Scans~     in approximately 1,000 patients randomised into the CRASH-3 trial.~   "
165239|NCT01402869|"~     To establish and compare maximum methemoglobin blood levels and times to maximum~     methemoglobin blood levels following the administration of the injectable local anesthetics~     prilocaine and lidocaine when used for dental treatment in pediatric patients under general~     anesthesia. Patients will be randomized into three equal study groups. Two of the study~     groups will receive local anesthetic and the third group will not. Methemoglobin blood levels~     will be non-invasively monitored and recorded throughout dental treatment for all groups~     using a Masimo Radical-7 Pulse Co-Oximeter device.~   "
165240|NCT01402856|"~     Teenage driving safety continues to be a major public health issue. Two factors have been~     found to contribute to a higher teenage driving accident rate than adults: lack of driving~     experience, and risky behaviors. Insufficient driving experience puts teenagers at a~     disadvantage in detecting and responding to hazards while driving. Factors contributing to~     distracted driving (a diversion in the driver's attention from the road) may include: talking~     or text messaging on a cell phone, applying makeup, having multiple passengers, listening to~     loud music, eating/drinking, smoking or reading while driving.~      This is a prospective study designed to evaluate the effect of an educational program on the~     risks associated with distracted driving for teenage drivers. The researchers will compare~     cell phone usage behaviors in Pennsylvania, where no cell phone laws are in place, and New~     Jersey, where cell phone laws exist, and will educate the beginner driver on the potential~     dangers associated with driving without a seat belt, substance use, and participating in~     distracting driving behaviors. Knowledge of state laws will also be assessed.~      Objectives~        1. Educate participants on the potential dangers of distracted driving.~        2. Evaluate the impact of the educational program on teenage distracted driving behaviors~          by obtaining and analyzing information from student surveys, state law quizzes, and~          anonymous observation, pre, post, and delayed post education.~        3. Quantify distracted driving behavior in teenage driver's attending local area high~          schools by obtaining and analyzing information from student surveys, state law quizzes,~          and anonymous observation, pre, post, and delayed post education.~        4. Qualify distracted driving behavior in teenage driver's attending local area high~          schools by obtaining and analyzing information from student surveys, anonymous~          observation, and anonymous voicemails, text messages, and/or emails pre, post, and~          delayed post education.~      Qualify distracted driving behavior in adults through anonymous observations near local area~     high schools.~      6. Compare teenage driving behaviors as reported and observed between Pennsylvania and New~     Jersey.~      7. Compare seat belt usage, driving behaviors, and substance use in the study population to~     the state and national averages pre and post education.~      8. Compare averages of student's knowledge of state driving laws pre and post education.~   "
165241|NCT01402843|"~     Pitavastatin, a representative statin-series anti-dyslipidemic drug, and Valsartan, a~     representative ARB-series anti-hypertensive drug, have been authorized for use also in South~     Korea. They have been tested in many countries and proved to be effective and safe. The~     concurrence of dyslipidemia and hypertension has a higher rate, hence statin-series drugs and~     antihypertensive drugs are simultaneously administered to such patients. The combined~     administration of statin-series drugs and CCB-series drugs have.~   "
165242|NCT01402830|"~     The purpose of this study is to evaluate the relationship between cancer pain and risk of~     depression among cancer patients.~   "
165243|NCT01402817|"~     This is a pilot study to determine if adults and children with neurofibromatosis type 1 who~     have plexiform tumors given Sutent® respond to this drug therapy.~   "
165244|NCT01402804|"~     Introduction:~      Different groups already showed in retrospective subgroup analyses, that there is an~     increased risk for cardiovascular events in patients on a simultaneous ASA/NSAID treatment.~      Methods:~      Light-Transmission aggregometry~      Hypothesis:~      Simultaneous administration of different NSAIDs and ASA impair the platelet inhibiting effect~     of ASA.~   "
165245|NCT01402791|"~     The primary objective of this study is to evaluate the presence/absence and description of~     persistent sexual troubles following surgical treatment for endometriosis for women, and~     their partners.~   "
165246|NCT01402778|"~     Major interest in our investigation is to find out whether distinct fixation techniques~     influence catheter dislocation and/ or incidence of local inflammation. A systematic~     comparison of two different fixation techniques with regard to catheter location, analgetic~     potential and signs of local inflammation will be conducted. To ensure identical patients~     groups allocation will be strictly randomized. Furthermore, both patient groups will receive~     identical pain medication via the peridural catheter in situ. All catheter tips will be~     screened microbiologically after removal.~   "
165247|NCT01402765|"~     The primary objective of this study is to compare the distribution of pressure among pressure~     interfaces between two anti-bedsore mattresses.~   "
165248|NCT01402752|"~     The primary objective of this study is to evaluate the reproducibility of a method of~     measuring blood flow rates to the tracheo-bronchial mucosa using diluted dimethyl ether as a~     tracer.~   "
165249|NCT01402739|"~     Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on~     several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants,~     and postoperative chest tube output. Allogeneic blood transfusion is associated with~     transfusion reactions, infection transmission, and postoperative morbidity and mortality. The~     aim of this study is to investigate, whether cardiac surgery patients have a reduced~     postoperative chest tube output and transfusion need when using a point-of-care guided~     transfusion algorithm compared to standard of care transfusion protocols.~   "
165255|NCT01402661|"~     The Corrona Data Collection Program study is designed to systematically collect and document~     use patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs),~     biologic agents and any other treatments currently used in the management of Rheumatoid~     Arthritis (RA), Undifferentiated Arthritis (UA), Psoriatic Arthritis (PsA), and other~     rheumatic diseases. Data collected through the Corrona Data Collection Program will be~     maintained in a comprehensive database (the Corrona Database), which will be used for~     purposes related to clinical, outcomes, and market research. Participating physicians will~     have access to information about their own participating patients, and may use this~     information for purposes such as research and in providing patient care. It is anticipated~     that the study data may help improve the quality of information upon which clinical decisions~     are based.~   "
165256|NCT01402648|"~     The decreased Estrogen Receptor beta (ERβ) expression in the non adenomatous mucosa of~     ApcMin/+ mice favours intestinal neoproliferation. The dietary supplementation with a blend~     of ERβ agonists and lignin has been shown to recover ERβ to the healthy wild type levels, and~     a reduced polyp number and lower dysplasia was also observed in the adenomatous mucosa. In~     this randomised, double blind and placebo controlled study, we assessed if ERβ similarly~     guides the apoptotic control of cell proliferation in the non adenomatous colon mucosa of~     patients affected from sporadic adenopolyposis, prone to polyp recurrence. For 60 day in~     advance of the screening colonoscopy, patients were supplemented with a dietary blend of ERβ~     agonists and lignin (Eviendep, CM&D Pharma Limited, London, UK) on top their common diet~     (left unchanged during the study period), to study if the pro-proliferative behavior of the~     non adenomatous mucosa was effected. Sixty patients naïve from previous and concomitant~     hormonal or anti-inflammatory CRC chemoprevention were sequentially 1:1 randomised to active~     or placebo supplementation. ERα and ERβ (mRNA, Western Blotting, Elisa, immunostaining),~     TUNEL, caspase-3 and Ki-67 (immunostaining) were assessed in bioptic normal colon mucosa~     samples. Study power: 80%, type 1 error: .05 (two-tails). Statistics: Non parametric Wilcoxon~     test for efficacy. MANOVA for proliferative and apoptotic biomarkers relationships to the~     common diet and to the 60 day supplementation.~   "
165257|NCT01402635|"~     The hypothesis of this study that the Point-Of-Care Chemistry Test (POCT) may shorten~     Emergency Department (ED) length of stay (LOS).~   "
165258|NCT01402622|"~     To maximize the surgical visual field, Robot-assisted laparoscopic radical prostatectomy~     (RLRP) usually requires the patient to be positioned in a steep trendelenburg position in~     combination with prolonged intraperitoneal carbon dioxide (CO2) insufflation and increased~     intrabdominal pressure. Insufflations of CO2 during laparoscopic surgery, which causes~     stretch and irritation of the peritoneum, is known to play an important role in postoperative~     nausea and vomiting (PONV). In addition, prolonged pneumoperitoneum increases the risk for~     PONV. PONV can cause patient discomfort and prolong post anaesthesia care unit (PACU) stay.~     In addition, the patient with PONV is also predisposed to severe complications such as~     aspiration pneumonia, increased wound dehiscence, delayed recovery, prolonged hospital stay,~     and eventually increased medical cost.~   "
165259|NCT01402609|"~     The transition between acute care and community care represents one of the most vulnerable~     periods in health care delivery, particularly as the complexity of inpatient populations~     increases. Two recent North American studies found an incidence of post-discharge adverse~     events between 19-23%, with adverse drug events accounting for 66-72% of these. The~     vulnerability of this period has been attributed mainly to a failure of care providers to~     adequately reconcile discrepancies between home medications and discharge medications, as~     well as a failure to transfer this and other important information about the hospitalization~     and discharge to community care providers. While discharge communication with the primary~     care physician has traditionally occurred via a handwritten or dictated summary, major~     deficits exist with respect to timeliness of information transfer and adequacy of content in~     discharge summaries.~      Computer-enabled discharge communications can potentially avert such problems. This is~     particularly true for web-based solutions that do not require end users to acquire additional~     software/training to use them. The purpose of this research is to definitively assess the~     efficacy of a web-based seamless discharge communication tool that the Medical Ward of the~     21st Century (W21C - see www.w21c.org) team in Calgary has developed through iterative~     consultation with multiple clinical stakeholders as well as patients/families. This tool has~     great potential to be implemented on a provincial level as well as across Canada and~     internationally because it operates on a web interface that does not confine its~     applicability to a single type of hospital information system.~      The purpose of this research is to definitively assess the efficacy of the web-based~     discharge communication tool that our team has developed in partnership with Alberta Health~     Services. In doing so, our specific objective will be to answer the following research~     questions:~        1. Is the seamless discharge communication tool efficacious with respect to reducing~          hospital readmission and mortality (at 3 months), as well as reducing adverse events and~          adverse drug events?~        2. Does the seamless discharge communication tool transfer appropriate, complete, and~          accurate discharge information in a timely manner compared to traditional discharge~          communication?~        3. Is the seamless discharge communication tool efficacious with respect to improving~          physician and patient satisfaction?~   "
165260|NCT01402596|"~     Thousands of children receive sedation for diagnostic and therapeutic interventions annually,~     and this number is expected to increase. Children are at higher risk for sedation-related~     complications than adults. In different scenarios, multiple drugs are used to achieve~     sedation, each one with particular adverse events that must be monitored and reported.~      Children that need CT scans for traumatic brain injuries often need sedation, without needing~     and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low incidence~     of adverse events; however, despite its worldwide use, it's being abandoned due to bitter~     taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam, on the~     other hand, produces high and fast concentrations on CSF with greater rates of success but~     probably with higher adverse events. There are no prospective studies with large series of~     patients using intranasal midazolam.~      The aim of this study is to determine if nasal midazolam is a safer approach and more~     effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT~     scans.~   "
165261|NCT01402583|"~     Menopause represents a critical period in a woman's life as the hormonal changes and the~     failing ovarian function not only determine relevant modifications in the reproductive~     function but also in many other conditions and organs that apparently are scarcely linked~     with hormones. The PI's centre has among its main goals the treatment of chronic liver~     disease; in the last years, a increasing interest in gender-related issues has grown.~      Goal of this study is to verify the impact of menopause on response to antiviral therapy for~     CHC and in determining more severe fibrosis in comparison with age-matched men. To achieve~     this goal a database of all the PEG IFN/Ribavirin patients treated in the GI Unit of the~     University of Modena and Reggio Emilia in the last 7 years will be set up. Demographic,~     clinical and biochemical data as well data regarding the reproductive history, time, type,~     length of estrogen deprivation and of hormone-replacement therapy will be collected.~   "
165262|NCT01402570|"~     In this study, people who have symptoms of post polio will take oral glutathione supplements~     for three months. Their levels of fatigue, physical activity and sleep efficiency will be~     assessed.~   "
165271|NCT01402453|"~     Despite unequivocal proof that tight control of blood pressure with antihypertensive~     medication can prevent hypertensive complications—including strokes, myocardial infarcts,~     heart failure, end-stage renal disease, and death— blood pressure remains uncontrolled in the~     majority of individuals with hypertension. We propose a novel patient-centered intervention~     that combines monetary incentives and a social psychological intervention to help patients~     sustain blood pressure control once incentives are no longer offered by strengthening~     intrinsic motivation to control blood pressure among two vulnerable populations: African~     Americans, who suffer disproportionately from hypertension, and Mexican Americans, who have~     the lowest hypertension control rates of any demographic group in the United States. If the~     intervention is successful, it could be adapted as a set of tools to apply in clinical~     practice to improve outcomes of a range of chronic diseases, by maximizing the motivation of~     patients to optimize their treatment.~   "
165272|NCT01402440|"~     This study has two phases, a dose escalation phase and a dose expansion phase. For dose~     escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in~     patients with diffuse large b-cell lymphoma. The endpoint for this objective will be~     occurrence of Dose Limiting Toxicity. For dose expansion, the primary objective is to~     characterize the safety and tolerability of the maximum tolerated dose or recommended phase 2~     dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoints for this~     objective will be occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs),~     assessment of clinical laboratory values, and vital sign measurements.~   "
165273|NCT01402427|"~     Background Verapamil is traditionally applied prophylactically in transradial procedures to~     prevent radial artery spasm. However, verapamil may have side effects and is contraindicated~     in some clinical settings.~      Methods: During an investigator‐initiated, randomized, double‐blind trial, we evaluate the~     need for preventive verapamil administration. After vascular access is established, patients~     receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site~     conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks~     (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural~     and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary~     end points.~   "
165274|NCT01402414|"~     In this controlled crossover study we aim to compare the efficacy of narrow-band UVB (NB-UVB)~     with bath-PUVA and NB-UVB plus salt water baths in atopic dermatitis.~   "
165275|NCT01402401|"~     This study will assess the safety and efficacy of AUY922, when administered, in combination~     with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received~     trastuzumab plus chemotherapy in the first line.~   "
165276|NCT01402388|"~     The study seeks to establish if weight loss achieved through a program of intensive lifestyle~     management can result in improvements in GLP-1 and glycaemic control, in patients with newly~     diagnosed type 2 diabetes mellitus.~   "
165277|NCT01402375|"~     There will be 3 randomized, double-blinded clinical trials to help determine which of~     commonly prescribed oral opioid combination is most effective in managing acute extremity~     pain after discharge from the adult emergency department. The first trial compares~     hydrocodone 5mg / acetaminophen 500mg to codeine 30mg/acetaminophen 300mg. The second trial~     compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg. The third~     trial compares oxycodone 5mg/acetaminophen 325 mg to hydrocodone 5mg/acetaminophen 325 mg.~   "
165278|NCT01402362|"~     High risk population: Screening for impaired glucose tolerance.~   "
165279|NCT01402349|"~     Introduction: Chronic Rhinosinusitis (CRS) is defined as inflammation of the nose and the~     paranasal sinuses. It is a very common disorder increasing in both incidence and prevalence~     with significant impact on quality of life and substantial health care costs. In this study~     we evaluate the prevalence of CRS in Denmark and there is a need for consensus about~     diagnosing this disease. Different questionnaires and different tests used for examination~     are evaluated together with the patients compliance and days lost through illness.~      Methods: As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on~     CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires~     self reported CRS was evaluated. Respondents were invited for clinical examination including~     spirometry, skin prick test, bloodsample and an ENT examination including nasal endoscopy,~     acoustic rhinometry, peak nasal inspiratory flow and smell test. Questionnaire on quality of~     life (EQ-5D) and symptom severity (SNOT-22) was completed. Medical diagnosed CRS was~     diagnosed according to the definition on CRS stated by EPOS (European Position Paper on~     Rhinosinusitis and Nasal Polyps 2007). CRS is defined as inflammation in the nose and~     paranasal sinus and should be characterized by two or more symptoms one of which should be~     either nasal blockage/obstruction/congestion or nasal discharge, +/- facial pain/pressure,~     +/- reduction or loss of smell. Endoscopic signs should be present and symptoms must have~     been present > 12 weeks. Patients diagnosed with CRS were invited for a 1 year and 2 year~     follow up where examination and questionnaires were repeated and treatment compliance and~     days lost through illness were evaluated.~   "
165280|NCT01402336|"~     GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been~     accomplished by several randomized controlled trials compared with conventional GnRH agonist~     long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating~     issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is~     to investigate the laboratory and clinical priority during ovarian stimulation for IVF in~     patients with PCOS treated with three different protocols.~   "
165281|NCT01402323|"~     Clefts or invaginations of the gingival tissue are a frequent finding during orthodontic~     space closure after extraction of a tooth. They occur in about 35% of the cases. Increased~     risk of developing a gingival cleft is given in the mandibular arch. A gingival invagination~     impairs aesthetics, orthodontic treatment and periodontal health. The aim of this prospective~     split-mouth designed observer blinded study is to evaluate possible differences between tooth~     movement in recent or in healed extraction sockets on incidence of gingival clefts. We~     hypothesize, that similar to the results originated from an animal study immediate movement~     in extraction sockets reduces incidence of gingival clefts during orthodontic space closure.~   "
165282|NCT01402310|"~     The purpose of this study is to compare Bishop score, sonographic cervical length and~     multiple proteins in cervicovaginal fluid at 40 weeks gestation to predict time to~     spontaneous labor and mode of delivery.~   "
165284|NCT01402284|"~     Background:~      - Carfilzomib is an experimental anti-cancer drug that has not yet been approved for treating~     multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the immune~     system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is~     sometimes used to treat (alone or with other drugs) certain types of cancer, especially~     multiple myeloma. This combination of drugs has not been tested in people with multiple~     myeloma. Researchers want to see whether it is safe and effective for this group.~      Objectives:~      - To test the effectiveness of combined carfilzomib, lenalidomide, and dexamethasone in~     treating multiple myeloma.~      Eligibility:~      - People at least 18 years of age who have multiple myeloma that has not been treated.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, a bone marrow sample, and molecular imaging studies.~        -  Participants will have eight 28-day cycles of treatment. The combined study drugs will~          be given as tablets and injections. Those in the study will be monitored with frequent~          blood tests, bone marrow samples, and molecular imaging studies. In addition to current~          standard measures to determine clinical responses, molecular tests will be conducted to~          define evidence of minimal residual disease.~        -  After the first four cycles of therapy, those who are eligible for a stem cell~          transplant will have stem cells collected and stored for use if the cancer returns.~        -  After stem cell collection, participants will have the second four treatment cycles.~           -, If the disease has improved or is stable at the end of eight cycles, those in the~          study may have another 12 cycles of low-dose (maintenance) lenalidomide alone.~        -  Participants will have regular follow-up visits after the end of the study chemotherapy.~   "
165285|NCT01402271|"~     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     pazopanib hydrochloride when given together with paclitaxel and carboplatin in treating~     patients with refractory or resistant ovarian epithelial cancer, fallopian tube cancer, or~     peritoneal cancer.~   "
165286|NCT01402258|"~     The purpose of this study is to determine whether tailored internet-administrated CBT is a~     feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive~     symptoms in a clinical setting.~   "
165287|NCT01402245|"~     Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia.~     The study aims to compare lymphocyte homing in pneumonia and in those receiving Pnc~     polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)~   "
165288|NCT01402232|"~     To raise optimal strategies for reduction of risk of contrast-induced nephropathy according~     to several combinations of different risk factors and clinical practice and determine and~     supply the guidance for clinical practice~   "
165289|NCT01402219|"~     The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN)~     following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque~     320) in patients with chronic kidney disease undergoing coronary angiography.~   "
165290|NCT01402206|"~     Most people in Sweden with mild to moderate depression are treated in primary care, but~     follow-up is unstructured, and we know little about whether structured, follow-up would~     affect the prognosis for depression and working life. The purpose of this study is to~     determine the effectiveness of regular, structured, patient-centered visits on mild to~     moderate depression.~   "
165291|NCT01402193|"~     The purpose of this study is to compare TGF-β1 change in concomitant with that in sequential~     Arimidex in postmenopausal women with breast cancer, as measured by the proportion of~     patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy~     relative to the pre-treatment baseline.~   "
165292|NCT01402180|"~     A randomized phase II tials to study whether it's benefit of adding Nimotuzumab to~     chemoradiation for patients with esophageal squamous cell carcinoma after radical~     esophagectomy who suffer with locoregional lymph nodes recurrence.~   "
165293|NCT01402167|"~     The primary objective of this study is to compare the volume of injected ciment (polymethyl~     methacrylate) between a group of patients treated with vertebroplasty and a group of patients~     treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral~     height, volume and cyphotic angle between the two techniques, as well as extravation of~     ciment and functional and quality of life aspects related to these techniques.~   "
165294|NCT01402154|"~     The primary objective of this study is to evaluate the predictive value (in terms of~     remission) of a new technique for detecting circulating, functional, prostate cells among~     patients with localized adenocarcinoma of the prostate, and prior to any treatment.~   "
165295|NCT01402141|"~     The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction~     in a double-blind, randomized, placebo-controlled, human trial~   "
165296|NCT01402128|"~     Barley, like oats, is a rich source of the soluble fibre β-glucan, which has been shown to~     significantly lower LDL-cholesterol (LDL-C). However, barley foods have been less widely~     studied.~   "
165297|NCT01402115|"~     Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They~     are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well as~     various mushroom. Studies have reported that extract of mushroom (Pleurotus eryngii) can~     prevent the bone loss caused by estrogen deficiency. Furthermore, polycan (a purified~     β-glucan from Aureobasidium pullulans) has been reported to exhibit osteoporosis preventing~     effects. However, no investigation has been conducted on the effect of polycan on bone health~     in perimenopausal women.~      Therefore, in this study, we investigated the effect of polycan on biochemical markers of~     bone metabolism in Korean perimenopausal women.~   "
165298|NCT01402102|"~     We performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects~     who were given aged garlic powder over a period of 12 weeks. We measured serum lipids,~     including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL)~     cholesterol, and triglycerides, and monitored their blood pressure.~   "
165299|NCT01402089|"~     It is well known that substantial interindividual variability of CYP3A4/1A2-phenotype~     activity is an important contributor to individual differences in the sensitivity to the~     frequently used tyrosine kinase inhibitors sunitinib and erlotinib. This study tests the~     potential for CYP-phenotyping to predict individual pharmacology and derive dosing algorithms~     for more tailored treatment of these drugs.~   "
165300|NCT01402076|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of midazolam (including its breakdown product) in the blood when midazolam is given~     with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the~     blood when rosiglitazone is given with tasimelteon.~   "
165302|NCT01402050|"~     OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled~     release prostaglandin (Cervidil™) for cervical ripening in term and near term women~     presenting for labor induction.~      HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley~     catheter will decrease the mean time from induction to delivery by six hours compared to~     controlled release prostaglandin (Cervidil™).~   "
165303|NCT01402037|"~     Increased glycemic variability has been proposed as an independent predictor of hypoglycemia~     in diabetic patients. Likewise, episodes of dysglycemia have been found to be predictive of~     diabetes in antibodypositive nondiabetic individuals. We hypothesise that an in-depth~     observational study comparing state-of-the-art measures of functional beta cell mass and~     glycemic variability will specify the relationship between both variables over a broad range~     of residual function and will identify treatment goals for functional beta cell mass to be~     reached in future beta cell therapy trials in order to avoid frequent hypoglycemia in~     patients and dysglycemia in risk groups. The available expertise and infrastructure (see~     background and (inter)national context) place the promoters of the present project in a~     unique position to carry out the planned experiments and support their feasibility.~   "
165304|NCT01402024|"~     Chemotherapy induced nausea and vomiting (CINV) is one of the few mostly observed distressing~     toxicity of cancer treatment. It can occur up to 90% in case of highly emetogenic~     chemotherapy use. CINV causes disturbance in daily living of cancer patient and reduces~     compliance with treatment Even with the standard anti-emetic measures up to 50% patient can~     suffer from this complication. Whereas there is standard anti-emetic guideline exists in case~     of adult patients, there no such guidelines made in pediatric population. The new drug~     Aprepitant has been recommended for use in adults with high efficacy, there no such concrete~     data available in children regarding its use. There are few retrospective reports and limited~     data available regarding use of Aprepitant in children with satisfactory efficacy in reducing~     CINV. As there no randomized large data to suggests its efficacy and its routine use in~     children, we have planned this study.~   "
165305|NCT01402011|"~     HYPOTHESIS: Prolotherapy, the injection of a growth promoting solution in injured ligaments~     and tendons of the shoulder is an effective treatment that decreases pain, increases~     functional capacity and promotes healing better and in less time than standard treatment with~     physiotherapy.~      OVERVIEW: 75 subjects with rotator cuff tendinopathy proven by ultrasound will be recruited~     and assigned randomly into one of three groups of 25 to receive one of these three different~     treatments:~      Group A (test): 25% dextrose with 0.1% lidocaine, injected into the tendons and ligaments~     Group B (control): 0.1% lidocaine injected in the rotator cuff tendons and ligaments Group~     C(control): 0.1% lidocaine injected subcutaneously above these structures All subjects will~     receive physiotherapy every other week for three months. To avoid placebo effects, patients,~     the radiologist and physiotherapist will not know to which treatment group the patients~     belong; the physician administering the injections will not be involved in assessing~     disability before or after treatment. (Note: The physician will know which patients belong to~     group C because it will be obvious: they are delivering a subcutaneous - versus a joint -~     injection).~      There will be three sets of injections - one set per month for 3 months. The patients'~     condition will be tracked for nine months after the first treatment, to monitor changes in 3~     outcome measures: pain (VAS and Rx #s), function (DASH and PESS), and tendon healing (as~     assessed by ultrasound).~   "
165306|NCT01401998|"~     In 2005, The University of Alabama at Birmingham established a NIDDK-funded,~     interdisciplinary center of excellence in PKD-related research, with specific emphasis on~     recessive PKD. In the previous Core Center award period, we developed a Core Resource to~     capture clinical and mutational data for ARPKD patients (Core A: ARPKD Clinical and Genetic~     Resource, NCT00575705). However, studies in the last several years have demonstrated that~     ARPKD and other single gene disorders characterized by renal cystic disease and extra-renal~     phenotypes share numerous pathogenic features. In the current competitively- renewed Center,~     we have expanded this Core resource to include other hepato/renal fibrocystic diseases.~      Goals for the Core A: The Hepato/Renal Fibrocystic Diseases Translational Resource are:~        1. - Clinical Database:~           • Expand our comprehensive Clinical Database to include information from all patients~          who meet the inclusion criteria for hepato/renal fibrocystic diseases.~        2. - Mutational Database:~             -  Test children with ARPKD and other hepato/renal fibrocystic disease to identify~               genetic mutations, establish a DNA bank for patients with hepato/renal fibrocystic~               diseases and develop a Mutational Database. This Database will be capable of~               linking clinical and mutational information via a unique identifier in a searchable~               format to facilitate genetic research (e.g. genotype-phenotype correlations, new~               disease gene studies, and modifier gene studies), translational studies, and~               clinical trials.~                3- Tissue Resource:~             -  Much of the research that is performed on diseases of the kidney, including~               recessive genetic diseases, requires human tissue from both affected as well as~               non-affected (controls) individuals. In this Core Resource, we are establishing an~               independent tissue resource which would supply investigators throughout North~               America with samples of hepato/renal fibrocystic disease affected tissues for~               studies of these disorders.~                4- Educational Resource:~             -  Expand our multi-media, web-based resource to provide a reliable up-to-date, and~               comprehensive informational resource for ARPKD and Hepato/Renal Diseases families,~               their physicians, and genetic counselors.~      All the information regarding participation in Core A: The Hepato/Renal Fibrocystic Diseases~     Translational Resource is available at: http://www.arpkdstudies.uab.edu/.~   "
165307|NCT01401985|"~     A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects~     with Opioid-Induced Constipation~   "
165308|NCT01401972|"~     In this observational study the investigators will undertake imaging studies on men with~     prostate cancer. The primary hypothesis is that ultrasound spectroscopy could be used to~     determine the extent of disease inside and outside of the prostate gland in patients with~     prostate cancer. It is hoped that the changes in ultrasound backscatter parameters obtained~     before radical prostatectomy could be used to correlate with pathological findings from the~     prostate specimen after surgery.~   "
165309|NCT01401959|"~     The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients~     who have residual invasive disease in breast or lymph node tissue following standard~     neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated~     separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and~     HER2-positive breast cancers.~   "
165310|NCT01401946|"~     The study was done to elucidate relationships between midlife women's self-reported hot~     flashes, neuropsychological symptoms, cognitive performance or sleep.~   "
165311|NCT01401933|"~     This is a phase 1, open-label study designed to determine the interaction of rifampin with~     linifanib.~   "
165373|NCT01401114|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Wellnara for postmenopausal~     osteoporosis. The objective of this study is to assess safety and efficacy of using Wellnara~     in clinical practice. A total 400 patients will be recruited and followed 3 years since~     starting Wellnara administration.~   "
165312|NCT01401920|"~     The trendelenburg position is usually applied to increase the cross-sectional area of the~     IJV. However, trendelenburg position requires a tilt table to place the head in the down~     position. Trendelenburg position could also increase intracranial pressure. Passive leg~     elevation redistributes more blood from the lower extremity into the central veins and is~     proved to increase the cross-sectional area of IJV in adults. However, the effect of leg~     elevation on the cross-sectional area of IJV in small infants and children has not been~     evaluated.~      The investigators evaluated the effect of passive leg elevation on the cross-sectional area~     of IJV in subjects undergoing open heart surgery for congenital anomaly.~   "
165313|NCT01401907|"~     The purpose of this study is to compare two types of care - standard oncology care and~     standard oncology care with early palliative care (started soon after diagnosis) to see which~     is better for improving the experience of patients and families with advanced lung and~     non-colorectal GI cancer. The study will use questionnaires to measure patients' and~     caregivers' quality of life, mood, coping and understanding of their illness.~   "
165314|NCT01401894|"~     The purpose of this research study is to assess what the participant understands about their~     illness, prognosis, the goals of the cancer treatment and their communication with their~     oncology providers. This study will help us to figure out how the investigators can improve~     how other patients understand their illness and goals of treatment and help us improve~     communication with their doctors. This research is being done because there is not a lot of~     information on how much patients understand about their illness and prognosis.~   "
165315|NCT01401881|"~     This study will assess relationship between ischemic time and the extent of myocardial~     infarction with cardiac magnetic resonance image in patients with STEMI (ST elevation~     myocardial infarction) and primary percutaneous coronary intervention.~   "
165316|NCT01401868|"~     The purpose of this study is to determine the tolerability of ME-143, find the maximum~     tolerated dose, and the safety profile in patients with refractory solid tumors.~   "
165317|NCT01401855|"~     This study will investigate the usefulness of an optical probe in the differentiation of~     thyroid cancer from normal thyroid tissue in a thyroidectomy specimen. This is the next step~     in the research that this team has conducted through our prior Institutional Review Board~     (IRB)H-28135, in which the investigators successfully demonstrated that use of the optical~     probe readings on thyroid specimens ex vivo could successfully discriminate benign from~     malignant disease. The Elastic Scattering Spectroscopy (ESS) probe has also been IRB approved~     and a clinical trial conducted in vivo at Boston University/Boston Medical Center by Dr.~     Satish Singh and Dr. Irving Bigio. The investigators intend to now bring this project to the~     clinical setting of thyroid disease. The optical real-time readings will be compared to the~     histological analysis from the same area. Subjects already undergoing thyroid biopsy for~     thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules~     will be eligible to participate. During the already scheduled thyroid procedure using a fine~     needle aspiration biopsy needle, optical readings will be taken from the thyroid gland and~     these same areas will then be analyzed in the usual standard fashion. The reading will then~     be correlated with the histological results. In addition, if lymph nodes are biopsied as part~     of the evaluation they will also be tested prior to histological standard processing. All~     specimens and data will be de-identified once data collection and analysis is complete. Our~     goal is to use optical real-time readings to improve the differential diagnosis of benign~     from malignant thyroid nodules and avoid surgery for the purpose of diagnosis alone.~   "
165318|NCT01401842|"~     The investigators will conduct a controlled clinical trial with U.S. Army soldiers training~     to become combat medics. The purpose of this study is to determine if a 11-week, high~     intensity exercise program targeting the low back muscles using specialized equipment will~     result in a 25% increase in low back muscular strength and endurance compared with a lower~     intensity general core stability exercise.~   "
165319|NCT01401829|"~     To determine if weekly exercise compared to stretching has an effect on fatigue, depression,~     and anxiety in endometrial cancer survivors.~   "
165320|NCT01401816|"~     Eighty-five percent of the 750,000 teenage pregnancies per year in the United States are~     unintended (Guttmacher Institute). Approximately half of all teenage pregnancies end in the~     birth of a child; the remaining proportion end in either abortion (30%) or miscarriage (20%).~     It has been estimated that if Emergency Contraception (Plan B) was used after every~     contraception failure, it could prevent 50% of unintended pregnancies and 60-70% of abortions~     annually.~      Previous studies have showed the effectiveness of emergency contraception decreases with time~     after intercourse; the sooner it is taken—even if it means a matter of hours—the more~     effective it is in preventing pregnancy. Based on previous studies, it is clear that relying~     on obtaining emergency contraception on the same day or even the day after unprotected~     intercourse is not guaranteed. For example, approximately 27% of pharmacies called by the~     adolescent mystery caller did not have the medication available the day of the call and~     almost all of the pharmacies not stocking the medication would take greater than 24 hours to~     obtain it through their ordering system.~      Thus, the concept of advanced provision of emergency contraception has been proposed to~     assure that the medication can be taken as soon as possible. Although this practice is known~     to be safe and has not shown any association with increased sexual risk or behaviors, it is~     unclear how often/if adolescents will fill a prescription for a medication that is not needed~     at the time of a medical encounter.~      The investigators propose a randomized pilot study (n=60) of a text-messaging intervention~     that aims to increase the rate at which prescriptions for emergency contraception are filled.~     Based on practice norms in the BMC Adolescent Center, sexually active female adolescents~     (ages 13-21) in both the control and intervention groups will be provided a prescription for~     emergency contraception. The intervention group, however, will receive follow-up text message~     on their phone reminding them to fill the prescription.~      Boston Medical Center Health Plan will provide prescription fill data regarding the~     prescriptions written at the time of enrollment. Approximately 6 weeks after enrollment, all~     study participants will be contacted for a follow-up survey.~   "
165321|NCT01401803|"~     The purpose of this study is to provide data to assess Dysport™ injections as a treatment~     therapy for brow ptosis. This study will assess the outcome of brow lifting with use of~     Dysport.~   "
165331|NCT01401660|"~     The purpose of this research study is to measure with CERSR® (Computerized~     Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the~     muscles in the lower back 1) when the subject has no low back pain 2) during the time low~     back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to~     study the changes which take place in these muscles as the pain improves with physical~     therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan~     parameters for normal (pain-free) subjects are different from those of subjects with low back~     pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment~     which leads to relief of low back pain following no more than eight weeks of physical~     therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as~     measured using the Oswestry Disability Index.~   "
165322|NCT01401790|"~     In a Pediatric University Teaching Hospital in Montreal, an Intelligent Distance Patient~     Monitoring Program was developed to allow for:~        -  Automatic download of blood glucose levels~        -  Automatic alerts indicating hypoglycemias, hyperglycemias and ketones to the medical~          team~        -  Changes in treatment plan by the diabetes professionals~        -  E mail exchanges between families and health care professionals~        -  Reinforcement of teaching program~      Use of this program does not replace the existing diabetes education program nor does it~     preclude contacts with the diabetes team. This service was devised to complement the care~     already in place for families of children and adolescents with diabetes, hence the term~     ''telehomecare-enhanced'' approach.~      Hypotheses~        -  This approach would not incur more health problems for Web e Phone users when compared~          to patients treated by the ''conventional'' approach (telephone and FAX).~        -  Use of the Web e Phone would save time for members of the diabetes health providers and~          consequently cut costs.~        -  This means of communication would be acceptable and user friendly for both families and~          health care professionals.~      OBJECTIVE - To determine the effects of a telehomecare (THC) program used for 3 months in~     families of children and adolescents with newly diagnosed type 1 diabetes.~      RESEARCH DESIGN AND METHODS - A bilingual telehomecare program was developed for type 1~     diabetes at the Centre Hospitalier Universitaire Sainte-Justine in Montreal. Between February~     2008 and August 2009, newly diagnosed patients and their family were randomly assigned to the~     standard education program or to the telehomecare-enhanced group. Outcomes of interest were~     patients' and parents' health (reported number for total and nocturnal hypoglycemias; quality~     of life using the Diabetes Quality of life for Youth questionnaire and a validated Life~     Habits survey); knowledge of diabetes (using pre and post intervention questionnaires);~     organizational impacts (number and time for contacts with the nurses or with the physician on~     call) and family satisfaction with the software application.~   "
165323|NCT01401777|"~     The objective of this study is to assess and quantify any differences between assisted (using~     real-time visualization of tracked cryo-probes) and unassisted cryoablation procedures using~     pre-procedure CT scans or CT fluoroscopy with respect to:~      Primary Endpoint:~      • TRE Target Registration Error (distance between virtual needle position (tracking data)~     and the actual needle position (CT confirmation scan))~      Secondary Endpoints~        -  Accuracy of needle targeting - The vector of each needle insertion (The initial vector~          allows us to project the path to the pre-defined target. If the initial entry point is~          not ideal, the path to the target will need adjustment) Based on a two-sample t-test~          (significance level of 0.05, two-tailed), the study has 89% power to detect a difference~          of 2mm in accuracy between the two treatment groups (assuming a standard deviation of~          1.9mm).~        -  Measure time difference between assisted and unassisted procedure~   "
165324|NCT01401764|"~     The purpose of the study is to compare local pain experienced after subcutaneous injection of~     three excipient buffers for delivering protein drugs.~   "
165325|NCT01401751|"~     The purpose of this study is to evaluate the performance of an insulin pump controlling~     algorithm while the subject is under close medical supervision in the Clinical Research~     Center (CRC) setting.~   "
165326|NCT01401738|"~     This study is a retrospective review of chart. Clinical results including range of motion,~     muscle power and scores will be recorded. Arthroscopic surgery of rotator cuff, labrum and~     capsule well be re-evaluated for clinical application.~   "
165327|NCT01401725|"~     Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels~     of the legs or lungs. They can block normal blood flow, damage organs, and even cause death.~     The risk of VTE is increased in people who are sick or immobile. VTE is the most common~     preventable cause of death in hospitalized patients, and its VTE prevention should be a top~     patient safety priority. Though there is good evidence that injectable blood thinners and/or~     compression stockings can prevent VTE, over 30% of hospitalized medical patients in Hamilton,~     Ontario receive inappropriate prevention. Hamilton Health Sciences Corporation is in the~     process of introducing electronic order sets - computer programs that help doctors order~     medications and other healthcare interventions for their patients. The investigators would~     like to study if these electronic order sets can help improve the rate of appropriate VTE~     prevention in hospitalized medical patients. The investigators will examine the rate before~     and after the introduction of electronic order sets at the Juravinski Hospital and the~     Hamilton General Hospital. Doctors at the Hamilton General Hospital will also get to use an~     additional computer program, called a computerized decision support system (CDSS), that helps~     them decide on the best strategy to prevent VTE in individual patients. The rates of VTE~     prevention at each hospital will be compared to each other, and to the rates at St. Joseph's~     Healthcare Hamilton, which will receive neither the order sets nor the CDSS.~   "
165328|NCT01401712|"~     Rib fractures are a common injury of trauma patients and can cause significant pain which, if~     inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure.~     Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are~     used to treat the pain, but placement can be risky as rib fractures are often associated with~     other injuries and complications.~      An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved~     device that automatically and continuously delivers medication to the region of the thoracic~     intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system~     effectively reduced pain and increased lung volumes after one hour, in patients with three or~     more rib fractures. However, that study sample was small and did not have a comparison group.~     In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We~     hypothesize that trauma patients with three or more rib fractures, who receive pain~     management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus~     have a shorter hospital length of stay (LOS) when compared with epidural analgesia.~   "
165329|NCT01401699|"~     The specific aim of this study is to determine the accuracy of Optical Coherence Tomography~     (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a~     clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using~     the developed OCT imaging probe will be determined and compared with those obtained through~     the traditional standard of care endoscopic biopsy .~   "
165330|NCT01401673|"~     The investigators hypothesise that cough reflex hypersensitivity, demonstrated in chronic~     cough patients, is due to a phenomenon known as central sensitisation. Central sensitisation~     is a hyper-excitability of the sensory nerves as they join the central nervous system, and is~     believed to be mediated by the N-Methyl-D-Aspartate (NMDA) receptor[1-3].~   "
165332|NCT01401647|"~     The primary objective of the trial is to determine if survival to hospital discharge is~     improved with early therapeutic administration of a new Captisol-Enabled formulation of IV~     amiodarone (Nexterone-PM101) compared to placebo.~   "
165374|NCT01401101|"~     The purpose of this study is to conduct a randomized trial of a Post Traumatic Stress~     Disorder (PTSD) Care Management (PCM) program to detect, treat, and improve PTSD treatment~     processes and outcomes in patients seeking primary care from FQHCs and evaluate its~     effectiveness on improving the processes and outcomes of care for PTSD.~   "
165333|NCT01401634|"~     Diabetes and high blood sugar are extremely common among patients presenting to US Emergency~     Departments. Intravenous fluids with or without insulin are often used to treat these~     patients. However, simple, low-cost interventions, such oral hydration have not been studied~     in this context. Oral rehydration may be better than no therapy at all, which is often what~     these patients receive in the first few hours when presenting to busy, overcrowded Emergency~     Department (ED) with long wait times, or in resource-poor environments such as developing~     countries. The investigators propose a study to see if oral hydration for adult patients~     presenting to the ED with high blood sugar i.e. finger-stick (FS) values between 250 and 500~     mg/dL can help lower blood sugar at the same rate as intravenous fluids. Half the patients~     will be given intravenous fluids per our department protocol, while the other half of the~     patients will be given 2 liters of water to drink over a 1-hour period. Both groups will have~     their blood sugar measured every 30 mins for 2 hours. The investigators will analyze the data~     to determine if there is a statistically significant difference in blood sugar between the~     two groups within 2 hours.~   "
165334|NCT01401621|"~     The goal of this project is to determine whether prompting the recipient of a health reminder~     mailing to scratch off targeted area.~   "
165335|NCT01401608|"~     This study will assess the outcomes of using magnetic navigation to treat ventricular~     tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons~     and are not related to structural heart disease.~   "
165336|NCT01401595|"~     The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in~     the treatment of the Night Eating Syndrome.~   "
165337|NCT01401582|"~     Caring for people with dementia and treating them is a major challenge for the health care~     system in Germany. Among the challenges for population-based health care research are (a)~     identification and early recognition, (b) multimorbidity and (c) the integration of persons~     with dementia into the health care system. One setting which is identified to meet the~     challenges is the primary care setting and there especially the general physician. There have~     been a few interventional studies, which have been restricted to selective samples and have~     been conducted in inpatient settings.~      The purpose of this study is to test the efficacy of implementing a subsidiary support system~     for persons with dementia living at home. This subsidiary support system is initiated by a~     Dementia Care Manager (DCM), a nurse with dementia-specific advanced training. The main goals~     are to improve quality of life and health care of the person with dementia and reduce~     caregiver´s burden.~      The study is a general physician based cluster-randomised controlled intervention trial. A~     population based sample of general physicians will be asked to participate in a systematic~     screening trial to identify people with dementia in primary care in Mecklenburg Western~     Pommerania (MV), a federal state in Germany. Upon identification the people will be asked to~     participate in the DelpHi-MV study and after having given written informed consent will then~     be assigned to an intervention and a control group. Identification of people with dementia~     will be achieved by a short screening questionnaire in the physician's office. An extended~     in-depth data assessment will be conducted after inclusion into the study and then annually~     to measure the course of the people's health. Data assessment will be done at the people's~     homes.~      People assigned to the intervention group will receive an intervention provided by Dementia~     Care Manager. The Dementia Care Manager is a specialised nurse that is going into the~     person's home to manage the care of dementia as well as caring for the person's relative/ or~     carer.~   "
165338|NCT01401569|"~     This study investigated the efficacy of an exercise and counseling intervention for depressed~     smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8)~     in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of~     intervention: individually delivered exercise and counseling (for smoking cessation and~     physical activity) or control: health education contact control condition.~   "
165339|NCT01401556|"~     The objective of the proposed research is to improve quality of care for older outpatients~     who present to Emergency Departments and Fracture Clinics with an osteoporosis-related wrist~     or other upper extremity fracture. Although most of these patients warrant evidence-based and~     guideline-recommended osteoporosis testing and treatment, numerous studies demonstrate~     treatment rates less than 10-20% in the year post-fracture. Several trials, including the~     investigators own prior studies, have tried to address this osteoporosis care-gap and have~     reported that various multifaceted interventions (combinations of patient and physician~     education, guidelines, and physician reminders) can modestly improve treatment rates compared~     with usual care, although 60-70% of the patients exposed to these interventions still remain~     untreated. The investigators believe that a case-manager (who identifies and independently~     sees patients in clinic, arranges bone mineral density [BMD] tests, and offers~     guideline-based treatment to those with low BMD) represents a potential solution that holds~     great promise.~      The investigators hypothesize that an osteoporosis case-manager will effectively and~     efficiently increase rates of osteoporosis treatment in older outpatients with upper~     extremity fractures when compared with a documented effective and cost-saving multifaceted~     intervention. To test this hypothesis the investigators propose a pragmatic patient-level~     randomized controlled comparative effectiveness trial with blinded outcomes ascertainment~     that compares the case-manager strategy with the multifaceted intervention.~   "
165340|NCT01401543|"~     This study compares LY2452473 taken orally as a 5 mg capsule at the same time as a 5 mg~     tadalafil tablet with three different combination tablets (LY900010) of 5 mg LY2452473 and 5~     mg tadalafil taken orally. The study will evaluate the amount of LY2452473 and tadalafil~     circulating in the blood for each treatment. Side effects will be documented. This study is~     approximately 34 days not including screening.~   "
165341|NCT01401530|"~     The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through~     observation of dose limiting toxicity (DLT), which is in advance defined, in patients with~     peripheral or cutaneous T-cell lymphoma.~   "
165342|NCT01401517|"~     Sodium nitrite has been demonstrated to promote new blood vessel growth, speed up wound~     healing and prevent tissue necrosis in animals. Since patients with PAD experience many of~     these problems, this study will seek to determine whether this drug, when given orally, could~     provide the same benefits to patients with PAD.~   "
165343|NCT01401504|"~     A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced~     malignancies (solid tumors).~   "
165359|NCT01401296|"~     200 persons with depression are recruited via internet depression forums devoted to~     depression and are randomly assigned either to the online program deprexis or to a wait-list~     control condition. All participants receive free-of-charge online access to deprexis either~     immediately or with an eight week delay.~      Prior to intervention and eight weeks later, both groups are assessed via an anonymous online~     survey which was implemented using the software package OPST®. The survey consists of~     different questionnaires. The Beck Depression Inventory (BDI) represents the primary outcome.~     It is assumed that the severity of depressive symptoms will improve to a significantly~     greater extent in the deprexis than in the wait-list control condition in the course of eight~     weeks.~   "
165344|NCT01401491|"~     Clozapine has been virtually the only psychopharmacological choice in patients with~     schizophrenia who either did not response to typical neuroleptics or experienced severe~     extrapyramidal side effects and consequently did not tolerate this medication. There are~     patients who do not respond to clozapine, and the need to treat these severely ill patients~     frequently compels clinicians to adopt therapeutic innovations that lack a sound empirical~     basis. One strategy is the combination of various other somatic treatments with clozapine.~      Recently, the investigators conduct a preliminary open trial to evaluate the safety and~     efficacy of fluvoxamine coadministration with clozapine in refractory schizophrenic patients.~     The combined treatment is well tolerated, and clinical improvement is observed in our~     patients. And the concomitant fluvoxamine could attenuate the clozapine-induced weight gain~     and metabolic disturbance. However, the effects of fluvoxamine on the safety and therapeutic~     efficacy of clozapine need to be further clarified in double-blind study.~   "
165345|NCT01401478|"~     Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at~     thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5~     Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the~     study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be~     assessed during the study.~   "
165346|NCT01401465|"~     This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with~     perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy~     of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel~     patient-administered assessment, developed and validated to measure patient satisfaction with~     and preference of intranasal corticosteroids (INCS) for the treatment of allergic rhinitis~     (AR), is utilized in this study.~   "
165347|NCT01401452|"~     This multicenter, post marketing observational study (PMOS) was designed to evaluate the~     effectiveness of adalimumab over a period of 9 months as determined by the Psoriasis Area and~     Severity Index (PASI) in participants with moderate to severe plaque psoriasis with distinct~     co-morbidities. Secondary objectives of this study were to measure changes in psychological~     health via the Dermatology Life Quality Index (DLQI); changes in comorbidities with respect~     to gender; changes in quality of life using the Short Form Health Survey (SF-36); and~     evaluation of Minimal Clinically Important Differences (MCID).~   "
165348|NCT01401439|"~     The purpose of this study is to find out whether measurement of body composition has a~     prognostic value on clinical and overall outcome in pediatric patients with cystic fibrosis.~   "
165349|NCT01401426|"~     Vertical Sleeve Gastrectomy has been shown to significantly reduce weight and has been~     approved as a treatment of morbid obesity. The standard laparoscopic operation requires five~     small incisions for the introduction of instruments and the band into the patient's abdomen.~     The investigators have developed a technique for performing this operation through a single~     incision at the belly button. This study compares this method to the conventional 5-incision~     approach.~   "
165350|NCT01401413|"~     The purpose of this study is to determine whether the use of the drug ramelteon decreases the~     symptoms of REM Sleep Behavior Disorder.~   "
165351|NCT01401400|"~     Background and rationale Chronic hepatitis B is the most common cause of liver cirrhosis and~     hepatocellular carcinoma worldwide.(1) Antiviral therapy with oral nucleoside analogs and~     interferon can reduce viral load and hepatic necroinflammation, and may reduce the risk of~     hepatocellular carcinoma and cirrhotic complications. (2-4) Peginterferon has both direct~     antiviral and immunomodulatory effects. The advantages of this drug include a finite course~     of treatment and the lack of drug resistance. However, it requires subcutaneous injections~     and carries some side effects. Besides, only 30% to 40% of treated patients have sustained~     response to treatment.(5-8) To reduce the costs and side effects of treatment, it is~     important to predict if a patient will respond to peginterferon. Genetic host studies on~     peginterferon response will provide a lot of knowledge on the interaction between the host~     and the virus to induce immune control, also outside the setting of immune modifying therapy.~     Recently, genome wide association studies (GWAS) identified genetic polymorphisms of the~     IL28B gene that were shown to be associated with treatment response to interferon and~     ribavirin in patients with chronic hepatitis C.(9-12) The same polymorphisms are also~     associated with natural clearance of hepatitis C virus. Whether the same phenomenon applies~     to patients with chronic hepatitis B is unclear. Furthermore, response to conventional~     interferon has shown to decrease the risk of hepatocellular carcinoma and to prolong~     survival.(13) Virological and serological response to PEG-IFN is durable in a substantial~     proportion of patients through 3 years of follow-up (14), but whether treatment benefits are~     sustained after that period and amount to clinically meaningful results is unknown. To date,~     a GWAS to predict the response to peginterferon in chronic hepatitis B patients has not been~     performed. Polymorphisms in genes such as IL28B can be identified through a GWAS and can be~     used to assess the chance of response to treatment and select patients who have a high~     probability of response to peginterferon.~      We aim to perform a GWAS in chronic hepatitis B patients previously treated with~     peginterferon to identify polymorphisms in genes that are associated with response to this~     treatment regimen.~   "
165352|NCT01401387|"~     This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical~     and mental health status and survival of patients who are diagnosed with pancreatic cancer~     and are highly likely to develop exocrine pancreatic insufficiency during their disease~     process.~   "
165353|NCT01401374|"~     The study is an on-line survey posted on survey monkey that addresses some demographic and~     environmental issues that could potentially relate to vitiligo vulgaris onset or disease~     exacerbation.~   "
165354|NCT01401361|"~     To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction~     with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter~        -  Does not result into unacceptable risk of intra-procedural composite serious adverse~          events and,~        -  Does not affect efficacy of the ablation procedure The study will also evaluate the~   "
165355|NCT01401348|"~     A research study to evaluate the effect of aging and HIV on neurocognitive dysfunction~     (declining ability to process information), physical frailty and heart disease. HIV-infected~     participants whose virus is controlled on antiretroviral medications will be studied to~     determine the rates and risk factors of developing these conditions.~   "
165356|NCT01401335|"~     The investigators propose a prospective single arm pilot cohort study of 100 youth (ages~     15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be~     enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a~     district of the Southern province, in Rwanda.~   "
165357|NCT01401322|"~     Time-to-Progression (TTP)~   "
165358|NCT01401309|"~     This study is to examine if there is improved sensitivity in detecting hepatic lesions using~     respiratory gating and if there is an improvement in confidence defining lesions as benign or~     malignant.~   "
165360|NCT01401283|"~     This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac~     index trending via a radial arterial line versus standard care in general surgical patients~   "
165361|NCT01401270|"~     The investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6~     conditions: (a) a control group, (b) a contingency management condition that arranges a 100%~     probability of winning a prize with each draw and has 3 prize categories, (c) a contingency~     management condition that arranges a 31% probability of winning and has 3 prize categories,~     (d) a contingency management condition that arranges a 100% probability of winning and has 7~     prize categories, (e) a contingency management condition that arranges a 31% probability of~     winning and has 7 prize categories, or (f) usual prize contingency management with a 50%~     probability of winning from 3 prize categories. Magnitudes of reinforcement will be identical~     across conditions, but lower overall probability conditions arrange for greater chances of~     winning larger magnitude prizes. The investigators expect that the new contingency management~     conditions will reduce cocaine use relative to the control condition, that 31% probability~     conditions will decrease drug use relative to 100% conditions, and that 7-prize category~     conditions will reduce drug use compared to 3-prize category conditions. In addition, the~     31%/7-category condition is expected to be most efficacious. Results will be instrumental for~     further developing prize contingency management to improve outcomes of cocaine-dependent~     methadone patients.~   "
165362|NCT01401257|"~     The present trial is a randomized, placebo-controlled study evaluating 3 different doses of~     PXT3003 in patients with CMT1A disease.~   "
165363|NCT01401244|"~     This trial is conducted in United States of America (USA). The aim of this trial is to~     examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.~   "
165364|NCT01401231|"~     This pilot study will examine the feasibility, acceptability, and effectiveness of a brief~     behavioral activation psychotherapy for women with perinatal depression.~   "
165365|NCT01401218|"~     Postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic~     aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases~     the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies~     for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore,~     the investigators tried to evaluate the incidence and risk factors of AKI after thoracic~     aortic surgery according to the diagnostic criteria and staging system of AKI reported from~     acute kidney injury network. The investigators also tried to develop a risk model with~     scoring system of AKI and evaluate the performance of the risk model.~   "
165366|NCT01401205|"~     The investigators applied upper airway ultrasonographic examination focusing the measurement~     of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate~     the change of upper airway anatomy before and after the surgery. The investigators also tried~     to find any findings of ultrasonographic examination that could reliably predict the dyspnea~     or airway compression after extubation. The investigators tried to compare the~     ultrasonographic findings with those of chest radiograph to validate the measurements of the~     ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to~     predict the upper airway obstruction in shoulder arthroscopic surgery.~   "
165367|NCT01401192|"~     This study trys to evaluate the predictive role of thymidylate synthase expression for~     pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).~   "
165368|NCT01401179|"~     The purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis~     and neonatal morbidity and mortality, and to review the evidence and provide recommendations~     on the use of antibiotics in PPROM.~   "
165369|NCT01401166|"~     This randomized, open-label, crossover study will evaluate participants' preference and~     healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in~     HER2-positive early breast cancer. Participants will be randomized to receive either SC~     Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other~     treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18~     cycles), participants will receive IV or SC Herceptin every 3 weeks.~   "
165370|NCT01401153|"~     Major aim of this study is to add scientifically proven insights into cognitive effects of~     meals to the existing recommendations for school meals in Germany. As a first step the~     short-term effects of skipping lunch on children's cognitive functioning in the afternoon~     will be examined in a cross-over trial. The study is conducted in a large comprehensive~     school in Gelsenkirchen (Germany) including about 150 children.~   "
165371|NCT01401140|"~     An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary~     revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac~     surgical interventions, it is performed with the heart stopped; this leads to more or less~     severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a~     duration that varies depending on the number of bypasses required, and on the local~     difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes.~     Heart protection during coronary revascularization surgery remains a crucial factor in~     limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting~     post-operatory ventricular dysfunction. Its quality is a determining factor of the~     post-operatory issue.~      High-performance heart protection solutions such as Custodiol have been used by heart~     surgeons for a few years. They are used as an alternative choice to other cardioplegic~     solutions, the efficacy of which has already been proven (St Thomas). These two myocardial~     protection solutions have never been evaluated in an in vivo, randomized, comparative trial.~   "
165372|NCT01401127|"~     People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but~     problems with metabolism and blood glucose control can make this difficult. Some people with~     T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous~     insulin infusion (CSII) therapy, in which a background or basal level of insulin is~     constantly infused under the skin by a special pump, with bolus doses of insulin given to~     accompany food. Clinical experience suggests that this may be particularly useful for~     managing diabetes for exercise, but there is limited experimental evidence to support this.~     The aim of this research , which is divided into three parts, is to investigate the~     hypothesis that the physiological response to sub-maximal (moderate) exercise of a person~     with type 1 diabetes treated with CSII, can be made to approximate more closely to the~     physiological response of a healthy individual by a prior reduction of their basal insulin~     infusion rate. This first part of the research is designed to compare metabolic response to~     exercise between people without diabetes and people with T1DM running there insulin pump at~     the usual basal rate.~   "
165378|NCT01401049|"~     The purpose of this study is to compare the incidence and intensity of possible pain on~     injection as well as patient satisfaction caused by propofol (a lipid based medication);~     Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a~     local anesthetic commonly used with propofol injection).~   "
165379|NCT01401036|"~     Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated~     stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting~     Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction~     (AMI). Accordingly, the investigators will compare the outcomes of primary PCI for AMI~     between patients receiving Nobori versus uncoated stents.~   "
165380|NCT01401023|"~     This is a prospective, non-comparative, interventional, observational pilot study of the~     safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral~     therapy in patients with known mild to severe confirmed Clostridium difficile associated~     diarrhea (CDAD).~   "
165381|NCT01401010|"~     Primary: To determine the serum pharmacokinetics (PK) of doripenem in febrile neutropenic~     patients.~      Secondary: Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported~     as Probability of Target Attainment (40% Time (fT)> minimum inhibitory concentration (MIC))~   "
165382|NCT01400997|"~     This is Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy~     in paediatric subjects using easypod™ electromechanical device for growth hormone treatment~     to assess the level of adherence of subject receiving SAIZEN® via easypod™.~   "
165383|NCT01400984|"~     This is a Slovakian, Multicentre, Observational Study to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth~     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.~   "
165384|NCT01400971|"~     The purpose of this study is to identify specific patient, physician, and health system~     related factors associated with the progression to a more intensive regimen from initial~     insulin therapy for patients with type 2 diabetes.~   "
165385|NCT01400958|"~     The purpose of this study is to determine if Nuvigil® improves fatigue experienced by people~     receiving external beam radiation therapy for the treatment of malignant gliomas. It is also~     being done to determine if Nuvigil® improves cognitive function (perception, thinking,~     reasoning, and remembering) and overall quality of life in people receiving external beam~     radiation therapy for the treatment of malignant gliomas. Another purpose of this study is to~     see if people who receive Nuvigil® have more or less side effects than people who receive~     placebo. Placebo is a substance that looks like an active drug but has no active ingredient.~   "
165386|NCT01400945|"~     The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD)~     patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.~   "
165387|NCT01400932|"~     This is a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group study~     in Japanese subjects with acne vulgaris to demonstrate the efficacy of GI148512 (benzoyl~     peroxide [BPO] 3% gel) when applied once daily for 12 weeks. This study will also evaluate~     the safety of GI148512 when applied topically once daily for 12 weeks.~   "
165388|NCT01400919|"~     The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming~     the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™~     Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common~     and/or external iliac arteries.~   "
165389|NCT01400906|"~     People with asthma suffer from breathlessness because the small tubes (bronchioles) that~     carry air in and out of the lungs become inflamed and narrow. Steroids reduce the~     inflammation, and are commonly used to control asthma, but they do not work well in some~     asthmatics, particularly those who smoke.~      This study is done to find out more about why smokers with asthma do not benefit from steroid~     treatment. In this study, the effect of Flixotide (fluticasone propionate), a steroid widely~     used to treat asthma, is tested in smokers and non-smokers with mild asthma.~      16 smokers and 16 non-smokers, aged 18−55 years will be enrolled in this study.~      Subjects will take each of the following treatments:~        -  100 micrograms Flixotide twice daily for 7 days;~        -  500 micrograms Flixotide twice daily for 7 days; and~        -  placebo (dummy medicine) twice daily for 7 days.~      Study design: subjects will have a screening visit (over 2 days), and will take part in 3~     treatment periods (which are separated by interval of at least 14 days); a follow-up visit is~     scheduled 7 days after the last intake of study treatment.~      The order in which order the subjects will take the treatments is defined at random. Total~     study duration: about 11 weeks.~      To test the effects of Flixotide, the subject's responses to :~        -  an inhaled allergen test~        -  a PC20 methacholine test~        -  blood, urine and sputum PD markers will be analysed.~      This study will take place in 2 centres: 1 in the United Kingdom and 1 in Belgium. The units~     will recruit participants by advertising (newspaper, radio, and websites), word of mouth,~     from volunteer databases, and via the centres' websites.~   "
165390|NCT01400893|"~     The purpose of this protocol is to evaluate the safety of a selective cytopheretic device~     (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney~     injury (AKI).~   "
165391|NCT01400880|"~     The specific goal of the proposed research is to develop a reliable, non-invasive fetal and~     maternal heart rate and contraction monitor that is unaffected by obesity and requires less~     nursing intervention than the tocodynamometer and Doppler ultrasound.~   "
165392|NCT01400867|"~     This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil~     in children with skin infections receiving antibiotic therapy in the hospital.~   "
165393|NCT01400854|"~     Aim of this non-interventional study is to investigate the tolerability of Effentora® in~     cancer pain patients with breakthrough pain under real-life conditions in clinical practice.~   "
165394|NCT01400841|"~     This investigation is a prospective, non-randomized, multi-center trial to evaluate the~     safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically~     repair a leaking aortic valve using a 3-D intra-annular mounting frame~   "
165395|NCT01400828|"~     The objective of the study was to determine the efficacy and tolerability of 20 mg of~     Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic~     Rhinitis.~   "
165396|NCT01400815|"~     A randomized, active controlled clinical trial in which a total of 216 healthy smokers will~     be enrolled and followed over approximately 19 weeks.~      The trial will evaluate the efficacy and safety of using X-22 as a smoking cessation aid.~      Healthy smokers who plan to quit smoking will be screened for eligibility. Subjects will be~     randomized in a 1:1 ratio to 1 of the 2 treatment arms:~        -  Group 1: X-22 Cigarettes (very low nicotine)~        -  Group 2: Active Control Cigarettes The randomization will be stratified by gender.~          Efficacy will be assessed by analysis of cigarette consumption using self-report diaries~          and measurement of exhaled CO and cotinine concentrations.~      Safety will be assessed by evaluation of adverse events, physical examinations, clinical~     laboratory tests, and measurement of heart rate, blood pressure, and body weight at each~     study visit.~   "
165397|NCT01400802|"~     The aim of this study is to assess the bioequivalence of two insulin analog mixtures: Listro~     Mix75/25® and Humalog Mix75/25® in healthy subjects based on the pharmacokinetic parameter~     (PK) and the pharmacodynamic parameter (PD).~   "
165398|NCT01400789|"~     The aim of this study is to assess the bioequivalence of two premixed formulations of insulin~     Lispro, Humalog Mix50/50® and ListroMix 50/50® in healthy subjects based on the~     pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).~   "
165399|NCT01400776|"~     Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due~     to vulvovaginal atrophy.~   "
165400|NCT01400763|"~     Macular pigment is composed primarily of the xanthophylls lutein and zeaxanthin, which are~     members of the carotenoid family. Epidemiological evidence indicates that a higher intake of~     lutein and zeaxanthin is associated with a lower risk to develop age-related macular~     degeneration (AMD). The lipid matrix of an egg yolk is an excellent vehicle for the efficient~     absorption of dietary lutein and it is possible to increase the natural lutein concentration~     in an egg yolk. A fresh lutein-enriched egg yolk beverage has been produced using these~     lutein-enriched egg-yolks. However, this beverage has a limited shelf life of maximum three~     weeks. Drying this fresh beverage extents the shelf live, however, this should be without~     loosing its functional properties concerning lutein bioavailability. At WUR-FBR two types of~     drying procedures have been evaluated resulting in two different dried product formulations,~     which need to be tested. The question is, whether the lutein bioavailability is not affected~     by different drying procedures.~   "
165401|NCT01400750|"~     Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone~     chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new~     Pa infection.~   "
165402|NCT01400737|"~     Patent ductus arterioses (PDA) is a major morbidity in preterm infants, especially in~     extremely premature infants less than 28 weeks. The clinical signs and symptoms of PDA in~     preterm infants are non specific and insensitive for making an early diagnosis of significant~     ductal shunting. Functional echocardiography is emerging as a new valuable bedside tool for~     early diagnosis of hemodynamically significant ductus, even though there are no universally~     accepted criteria for grading the hemodynamic significance. Echocardiography has also been~     used for early targeted treatment of ductus arterioses, though the long term benefits of such~     strategy are debatable. The biomarkers like BNP and N- terminal pro-BNP are currently under~     research as diagnostic marker of PDA. The primary mode of treatment for PDA is~     pharmacological closure using cyclo-oxygenase inhibitors with closure rate of 70-80%. Oral~     ibuprofen is emerging as a better alternative especially in Indian scenario where parenteral~     preparations of indomethacin are unavailable and side effects are comparatively lesser.~     Though pharmacological closure of PDA is an established treatment modality, there is still~     lack of evidence for long term benefits of such therapy as well as there is some evidence for~     the possible adverse effects like increased ROP and BPD rates, especially if treated~     prophylactically.The aim of this study is to investigate the effect of oral ibuprofen~     prophylaxis administrated on the first 24 hours of life and the following two days on~     hemodynamically significant patent ductus arterioses and its long term effects such as ROP~     and BPD.~   "
165403|NCT01400724|"~     A prospective, randomized, controlled, open-label study will be carried out on 80~     post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP~     III). After a written informed consent, women will be randomly treated for 6 months with~     hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg~     plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty~     post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40~     treated with myo-inositol 2 g twice per day and forty treated with placebo for six months.~     The investigators hypothesize that the administration of myo-inositol would improve the~     insulin-receptor activity in these women, reducing insulin resistance.~   "
165404|NCT01400711|"~     Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of attenuating~     the stress response to surgery and enabling rapid recovery. There is strong evidence of the~     usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of~     significantly reduced postoperative complications and shorter length of hospital stay,~     compared to the patients of traditional treatment. However, few studies exist about the~     implication of ERAS programs in major upper abdominal surgery patients.~      The aim of this study was to compare morbidity, mortality and length of stay in patients~     undergoing major intrabdominal surgery, including upper and lower gastrointestinal, receiving~     either conventional postoperative care or an ERAS program.~   "
165419|NCT01400516|"~     Summary:~      The investigators propose a randomized controlled open label study of teriparatide in men or~     women with rheumatoid arthritis and joint erosions. Specifically, the investigators will~     examine whether teriparatide in combination with a biologic can retard the development of~     joint erosions. The study will be conducted at Brigham and Women's Hospital Arthritis Center,~     several Brigham and Women's Hospital Arthritis Center satellite practices, the University of~     Massachusetts Medical Center, and Massachusetts General Hospital.~      Hypothesis:~      The investigators hypothesize that the combination of teriparatide with biologic will be much~     more effective at retarding erosion progression then a biologic alone.~   "
165420|NCT01400503|"~     The purpose of this study is to evaluate the long-term safety of siltuximab in patients with~     multicentric Castleman's disease (MCD).~   "
166034|NCT01392495|"~     This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety,~     tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension~     patients.~   "
165405|NCT01400698|"~     Study of safety of Saizen® in children born with serious intra-uterine growth retardation~     (IUGR) treated to final height. An open, phase III study involving 17 centers in France.~      The study enrolled children who have completed 3 or 2 years of treatment and at least one~     year of post treatment observation in the Sponsor Studies GF 4001 (Safety and Efficacy of~     Saizen in the Treatment of Young Children Born with Severe IUGR) or GF 6283 (Effect of~     Intermittent versus Continuous Saizen Therapy in Young Children Born with Severe IUGR),~     respectively.~      Detailed description: Serious IUGR is a syndrome characterized by low birth length and weight~     for gestational age (less than 10 percentile). The secretion of growth hormone in response to~     provocative stimuli (e.g. arginine, insulin) is normal in these children. Apart from low~     birth weight, children born with IUGR may have minor or major malformations.~      A catch-up period with a supraphysiological growth velocity generally occurs during the first~     6 to 24 months of life in 80 to 90 percent (%) of these children. This generally allows them~     to reach normal height. That means that conversely, approximately 10 to 20% of children do~     maintain a statural handicap. Puberty occurs at a normal age and the retardation in bone~     maturation present during the first years of life disappears very quickly. This leads to~     short adult stature in subjects who have not shown spontaneous catch-up during the first~     years of life. A safe and effective means of promoting growth without accelerating the timing~     or tempo of puberty would therefore be desirable.~   "
165406|NCT01400685|"~     Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify~     or regulate the functioning of the immune system. It is an FDA approved drug for people with~     multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL),~     but it does appear effective in CLL when used alone, and is being studied for use in~     combination with chemotherapy in this and other lymphomas and leukemias.~      In this research study we are hoping to learn more about the effects of lenalidomide on CLL~     when given in combination with bendamustine and rituximab, which is a highly effective~     regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest~     dose of lenalidomide that can be given safely, without causing any serious or unmanageable~     side effects.~   "
165407|NCT01400672|"~     This is a pilot/feasibility study. The study design represents a modification of current~     standard of care for Diffuse Intrinsic Pontine Glioma (DIPG) (5580 cGY involved field~     radiation), with the final two doses of radiation given at intervals during the vaccination~     phase of treatment.~      Patients between the ages of 3 years and 25 years diagnosed with Diffuse Intrinsic Pontine~     Glioma (DIPG) will be allowed to participate in the trial. Study enrollment will occur after~     the completion of conformal radiation therapy to a dose of 5580 cGy and the post radiation~     therapy (RT) magnetic resonance imaging (MRI) shows no disease progression.~      Three patients with glioblastoma multiforme, aged 16 years and older, will be entered first~     to confirm vaccine safety before enrolling DIPG patients.~   "
165408|NCT01400659|"~     The Pizza-Salami-Study aims to investigate the efficacy of carbohydrate plus fat/protein~     (CFP) counting compared with carbohydrate (CARB) counting using normal and dual-wave bolus in~     sensor-augmented pump therapy in children and adolescents with type 1 diabetes. For~     fat/protein counting the model used by Pankowska et al. will be applied.~   "
165409|NCT01400646|"~     The purpose of this study is to explore the pharmacodynamic (what the drug does to the body)~     changes when transitioning from rivaroxaban 20 mg once daily to warfarin dosed to a~     therapeutic level as measured by the International Normalized Ratio (INR) range of 2.0 to 3.0~     in healthy volunteers. In addition, the pharmacokinetics (what the body does to the drug),~     safety and tolerability of rivaroxaban during the transition to warfarin will be~     investigated. The INR is obtained from a blood test, and is a measure for the clotting~     tendency of the blood used for safe and adequate dosing of warfarin.~   "
165410|NCT01400633|"~     The purpose of this study is to investigate the overall response rate (ORR) and safety when~     treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be~     administered as long as there is evidence of clinical benefit.~   "
165411|NCT01400620|"~     The purpose of this study is to determine whether an oral rinse composed of botanical~     extracts is effective in the prevention of severe inflammation of the lining of the oral~     cavity caused by chemotherapy and radiation therapy for head and neck cancer.~   "
165412|NCT01400607|"~     ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the~     safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4~     articular cartilage lesions of the knee compared to microfracture treatment.~   "
165413|NCT01400594|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.~   "
165414|NCT01400581|"~     The purpose of this study is to evaluate the effectiveness of a collaborative care~     intervention for evidence based management of alcohol use disorders in primary care settings~     within the Veterans Administration Puget Sound Health Care System (Seattle and American Lake~     Divisions). The study will test whether patients offered the collaborative care intervention~     have fewer heavy drinking days at 12 months follow-up and to be abstinent or drinking below~     recommended limits without problems.~   "
165415|NCT01400568|"~     This pilot study is planned to assess the suitability of a low dose Lipopolysaccharide (LPS)~     inhalation as a challenge model. As LPS effects are based on a different mode of action, this~     challenge model will provide the possibility to test a wider spectrum of potential drugs in~     the future. Provided that the LPS response is reproducible, it is planned to test whether a~     single high dose of inhaled steroid can serve as a positive control in the LPS model. Another~     major aim of the study is to test a variety of novel tools for the non-invasive assessment of~     airway inflammation induced by LPS challenge.~   "
165416|NCT01400555|"~     The purpose of this study is to evaluate the maximum safe dose of abiraterone acetate~     administered in combination with docetaxel plus prednisone in patients with metastatic~     castration-resistant prostate cancer (mCRPC).~   "
165417|NCT01400542|"~     Obstructive sleep apnea (OSA) is much more common in the elderly than in the young; the~     latest studies show prevalence between 45% and 62% in individuals over 60. It is even higher~     in patients with dementia such as Alzheimer patients.~      Several trials in elderly patients showed modified cognitive functions, particularly~     executive and attentional functions, in patients with respiratory sleep disorder. However the~     benefit of CPAP (Continuous Positive Airway Pressure) ventilation for Alzheimer patients is~     still controversial, as there are few studies documenting its effects on dementia patients'~     cognitive abilities, and clinicians appear reluctant to prescribe this type of treatment.~      The investigators must keep in mind that Alzheimer patients suffer significant sleep~     disorders; advanced- stage patients spend 40% of the night awake and are drowsy a large part~     of the day. In dementia patients, sleep disorder is a major cause of hospitalization and~     institutionalization. The prevalence of obstructive sleep apnea (OSA) in this population is~     estimated at over 50%, and appears to be higher the more advanced the dementia. Trials on~     obstructive sleep apnea syndromes in Alzheimer patients show significatively improved scores~     on the apnea-hypopnea index (AHI), as well as satisfactory treatment tolerance. However, any~     impact on cognitive abilities has yet to be demonstrated.~      In addition, cardiovascular pathologies such as arterial hypertension, cardiac arrhythmias,~     and strokes are strongly correlated to OSA. In light of its consequences on morbidity and~     mortality, OSA should be considered a public health issue.~      In this context, the investigators wish to address the impact of CPAP treatment~     implementation on the cognitive parameters of patients diagnosed with OSA, particularly on~     their executive functions. This should provide evidence for mid-term assessment of the~     benefits of CPAP in caring for elderly patients with dementia.~      In light of the prevalence of obstructive sleep pathologies in elderly patients reported in~     various studies and of the potential impact of CPAP treatment on cognitive abilities, the~     investigators propose a study to evaluate the impact of OSA treatment on elderly Alzheimer~     patients' cognitive abilities, particularly on their executive functions.~      Executive functions are a rather heterogenous group of high-level cognitive processes which~     enable individuals to adopt a flexible, context-appropriate behavior. They also include~     planning abilities, working memory, cognitive control, abstract thought, rule learning,~     selective attention, motor response selection, etc... Executive functions are mainly~     associated to the functioning of the brain's frontal lobes, although subcortical structures~     also play a role. When the executive functions are affected by disease, daily life is~     significantly impeded as the individual becomes unable to perform complex tasks or regulate~     his/her behavior. Many tests can help evaluate these functions in dementia patients. A number~     of ecological tests, such as the zoo map test from the Behavioural Assessment of the~     Dysexecutive Syndrome (BADS) arsenal, are quite relevant for evaluating executive functions.~      This project aims to improve the daily life of Alzheimer patients with sleep apnea by~     improving their executive cognitive functions through CPAP treatment.~      According to the Paquid's trial, there are 12,400 Alzheimer patients in the French Loire~     department. [27] The study population will therefore be recruited in the La Charité center~     of CHU Saint-Etienne. The target population is older individuals (≥ 65) suffering from~     cognitive disorders similar to Alzheimer's disease.~      OSA will be diagnosed based on polysomnography, on an outpatient basis. Apnea patients will~     receive CPAP treatment for 4 months, which is the minimum duration required to implement and~     accept treatment, and to measure its impact on patients' neurocognitive abilities.~   "
165418|NCT01400529|"~     Nationwide descriptive epidemiology survey aiming to determine lower limb OA prevalence,~     based on a validated method previously used to assess inflammatory rheumatism (rheumatoid~     arthritis and spondylarthropathy) prevalence in France.~   "
194744|NCT01014377|"~     The purpose of this study is to assess the safety and the immediate effect of the VascuActive~     device on patients with peripheral vascular disease and limb ischemia.~   "
165421|NCT01400490|"~     The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a~     DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind,~     randomized, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of~     EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200 mg~     of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a parallel~     arm design study of 120 healthy adults studied in both the fasting and post-prandial state.~     Safety will be monitored by assessing for adverse reactions, measuring vital signs and a~     variety of lab tests including a complete metabolic profile and complete blood count.~     Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid~     ratios,as well as by measuring plasma lipids, lipoproteins, and markers of inflammation.~   "
165422|NCT01400477|"~     The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene~     anabaseine sustained release) will provide clinical improvement in cognition in patients with~     schizophrenia who are smokers and who are non-smokers. The study drug may also maintain~     abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.~   "
165423|NCT01400464|"~     The factors underlying the large interindividual variability in response to glucocorticoids~     in Giant Cell Arteritis are poorly understood. The investigators hypothesize that a part of~     this variability is related to pharmacokinetic factors determined by genetic polymorphism:~     hepatic clearance involving cytochromes P450 of the subfamily 3A (CYP3A) and drug efflux~     leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs (ABCB1). The~     investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic~     cohort study to assess the link between prednisolone clearance and the relapse risk in giant~     cell arteritis.~   "
165424|NCT01400451|"~     Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of~     the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and~     the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and~     feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison~     to historical results following treatment with either agent alone.~   "
165425|NCT01400438|"~     Many studies have been devoted to the quality of life of patients during adjuvant~     chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on~     the immediate environment (spouse, children) during this difficult time for women. Curiously,~     no study to date has been submitted or published about how women with a one-year treatment~     extra Herceptin ® live this period in terms of quality of life, in terms of psychological~     impact for themselves and their families.~      The investigators have no more data on how often they return to work during this treatment or~     on the psycho-social parameters which underpin them. It therefore seemed interesting to give~     a spotlight on this particular period in these women HER2 + by comparing a patient~     population of same age receiving the same adjuvant but with no Herceptin ®.~   "
165426|NCT01400425|"~     The study is designed to evaluate whether a florbetapir F 18 PET scan can impact clinical~     thinking when physicians are determining the likely cause of a subject's cognitive~     impairment.~   "
165427|NCT01400412|"~     The main purpose of this study was to compare the effects on bones of the following two drug~     combinations:~        -  maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r)~        -  tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r)~      Additional study objectives were the following:~        -  To see how the drug combinations affect the brain and kidneys.~        -  To see how well the drug combinations lower the HIV viral load.~        -  To see how safe the drug combinations are, how well people are able to take the study~          drug combinations, and how well their immune systems respond to the study drugs.~   "
165428|NCT01400399|"~     This study will evaluate the cosmetic outcome and examine factors contributing to cosmetic~     outcome in women treated with lumpectomy or bilateral breast reduction mammoplasty/mastopexy~     (BRM) followed by hypofractionated whole breast irradiation. Breast conservation is now an~     established method of treatment for early breast cancer. Because breast conservation is~     essentially a cosmetic alternative to mastectomy, quality of life, cosmetic outcome and tumor~     control are all important considerations during comprehensive treatment planning. Irradiation~     schemes have been demonstrated to be efficacious and with excellent short term cosmetic~     outcomes. However, their interaction with currently evolving surgical techniques needs to be~     examined in order to maintain optimal local control while preserving cosmetic outcome.~   "
165429|NCT01400386|"~     Coffee contributes to a large extent to our daily intake of phenolic compounds which have~     been associated with potential health benefits. A study by Richelle et al. (2001), using an~     LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity~     which varied depending on the coffee bean source and the degree of roasting. Little is known~     about the bioavailability of phenolic compounds from coffee at various roasting degrees.~     Therefore, further human studies are required in order to demonstrate the absorption, and~     bioavailability of metabolites that may also be efficient in vivo.~      The main objective of this clinical trial is to investigate the possible difference in the~     bioavailability of chlorogenic and phenolic acids from coffee at various roasting levels.~   "
165430|NCT01400373|"~     Promising result of intra-arrest cooling on neurological intact survival in cardiac arrest~     patients has recently been published in the PRINCE-study in Circulation 2010.~      The main purpose of this study is to determine whether prehospital intra-nasal cooling~     initiated during resuscitation, in addition to systemic cooling at hospital, increases~     neurological intact survival measured as cerebral performance category score (CPC-score)at 90~     days in witnessed cardiac arrests outside hospital.~   "
165431|NCT01400360|"~     Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount~     of transient or even permanent neurological deficits and poor outcome of the patients.~     Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators~     represents a rescue therapy for severe CVS. Indication, duration and efficacy of this~     treatment, however, is still under debate. Aim of the study is to investigate if such a~     rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH.~     Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive~     intraarterial therapy to more than 50 %.~   "
194858|NCT01012882|"~     The purpose of this study is to evaluate the efficacy and safety of specific sublingual~     immunotherapy (SLIT) with allergen extracts in patients suffering from seasonal allergic~     rhinitis .~   "
165432|NCT01400347|"~     It is generally accepted that the effectiveness of an exercise can be controlled not only by~     the weight or resistance applied but also by doing an exercise that would better target the~     desired muscle. The purpose of this study is to obtain objective information regarding~     selected lower extremity muscle activity during specific exercise and the influence of~     fatigue and speed on muscular activation.~   "
165433|NCT01400334|"~     The hypothesis of PAREPET is that hibernating myocardium (viable myocardium with reduced~     resting flow) and/or viable but denervated myocardium can predict the risk of sudden death in~     subjects with ischemic cardiomyopathy.~   "
165434|NCT01400321|"~     The open, prospective, non-controlled observational study is designed to provide information~     on the short-, medium- and long-term clinical performance of the Astra Tech OsseospeedTM~     implant surface in combination with a special implant design. The study will provide~     information on implant survival and soft tissue and bone maintenance as clinical performance~     of the OsseoSpeedTM TX Profile Implant in the aesthetic zone or the posterior mandible with~     socket like atrophy.~   "
165435|NCT01400308|"~     Multicenter Clinical Trial, experimental, randomized and prospective study to determine the~     effectiveness of two protocols addressing the Corporal Decolonization in patients colonized~     by Methicillin Resistant Staphylococcus Aureus (MRSA).~      PRIMARY END POINT The aim of this trial is to evaluate the effectiveness of the protocol~     Prontoderm® in the decolonization of MRSA patients, compared with the protocol of the~     Consensus Document and GEIH-SEIMC SEMPSPH (see attached extract from the document, Annex~     7).~      Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and~     currently available in Spain for the same indications proposed in this trial.~   "
165436|NCT01400295|"~     To determine a relatively safe contrast media volume to creatinine clearance cut-off value to~     avoid contrast-induced nephropathy in patients following coronary angiography~   "
165437|NCT01400282|"~     The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and~     sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation~     (Conv SCS) on the patient reported global impression of change, pain intensity and health~     related quality of life.~   "
165438|NCT01400269|"~     The purpose of this study is to assess the efficacy of a parent training program in the~     treatment of social and communication deficits in children with autism. Specifically, this~     study will evaluate a developmentally based parent delivered intervention in the community~     developed by Pacific Autism Center for Education (PACE).~   "
165439|NCT01400256|"~     The investigators hope to show that valsartan can be used safely in the setting of acute~     stroke to lower elevated blood pressure. There are novel properties of this class of drug (an~     angiotensive-receptor blocker or ARB), and promising human and animal data, that would~     suggest this drug can be safely used to lower blood pressure in the setting of acute stroke~     without compromising brain blood flow (i.e. cerebral perfusion). If this is proved to be the~     case, this compound could potentially be used routinely in this setting, with the hope of~     improving outcome. This pilot study may pave the way for a larger randomized trial looking at~     outcome measures in stroke patients. Further, a positive result in the this pilot study will~     serve as proof of concept that ARBs maintain cerebral perfusion while decreasing blood~     pressure, an overall favorable property.~   "
165440|NCT01400243|"~     The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus~     placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a~     randomized, double-blind, and placebo-controlled design. This proposal is in response to~     RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders. Consistent with~     the goals of this RFA, the overall goal of the proposed project is to assess the impact of~     transdermal nicotine patch (TNP) on marijuana (MJ) withdrawal (negative affect and craving~     motivated by negative affect) symptoms in MJ-dependent individuals.~   "
165441|NCT01400230|"~     Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect~     ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive~     techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic~     intra-luminal images. Coronary computed tomographic angiography (CCTA) is helpful to assess~     precise anatomical information. Optimal functional criteria and their accuracy of IVUS and~     CCTA by fraction flow reserve (FFR) have not been compared yet.~   "
165442|NCT01400217|"~     This study will compare the absolute and relative effectiveness of asthma management in~     patients on inhaled corticosteroid (ICS) maintenance therapy as either extra-fine-particle or~     larger-particle formulation beclomethasone dipropionate (BDP) via metered-dose inhalers~     (MDIs) using the propellant hydrofluoroalkane propellant (HFA-BDP), namely Qvar® MDI compared~     with Clenil® MDI.~   "
165443|NCT01400204|"~     The aim of the study is to compare hangover effects of MDMA users versus those who used other~     drugs, or alcohol only at New Year's Eve. The week after New Years Eve, every day~     participants complete a questionnaire about the presence and severity of potential hangover~     symptoms. At day 1, demographics and alcohol and drug use at New Years Eve were recorded. On~     day 7, the Brief Symptom Inventory (BSI) is completed to asses last weeks mood. After 4~     weeks, after a drug-free week, the BSI is completed again to serve as a reference.~   "
165444|NCT01400191|"~     The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy~     Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the~     study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy~     volunteers with functional OCT1-transporters.~   "
165445|NCT01400178|"~     Objectives: To assess a group of post-lingually children after 10 years of implantation with~     regard to speech perception, speech intelligibility, and academic/occupational status.~      Study Design: A prospective transversal study. Setting: Pediatric referral center for~     cochlear implantation. Patients: Ten post-lingually deafened children with Nucleus and Med-El~     cochlear implants.~      Interventions: Speech perception and speech intelligibility tests and interview.~      Main Outcome Measures: The main outcome measures were score of Hint sentences recognition~     (silence and noise), speech intelligibility scores(write-down intelligibility and rating~     scale scores) and academic/ occupational status.~   "
165620|NCT01397890|"~     This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV~     design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva~     compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease~     (COPD).~   "
165446|NCT01400165|"~     Generic describes a pharmaceutical product that does not have a brand name or trademark.~     Generic medications should be the equivalent of brand medications. Only their price should be~     different. The active ingredient of the generic medication has to be within a window of 80 to~     125% of the original in the blood. There are reports that this standard is not always~     followed after the medication has been on the market. Indeed, it was observed that some~     patients previously stable on original medications relapsed when switched to a generic.~     Several factors could account for this problem. Such problems have been reported for~     Pindolol, Quetiapine, and Trazodone. Some properties of specific brands of the generics and~     the original brands will be examined for these three medications. The three original~     medications used in this study are the Visken, the Seroquel, and the Desyrel. The three~     generics are the Teva-pindolol, the Teva-Quetiapine, and the Teva-Trazodone. They are all~     available on the Canadian market by prescription.~   "
165447|NCT01400152|"~     Prevention and treatment of hypothermia by active warming in prehospital trauma care is~     recommended but scientifical evidence of its effectiveness in a clinical setting is scarce.~     The objective of this study was to evaluate the effect of additional active warming during~     road or air ambulance transportation of trauma patients.~      Patients were assigned to either passive warming with blankets or passive warming with~     blankets with the addition of an active warming intervention using a large chemical heat pad~     applied to the upper torso. Ear canal temperature, subjective sensation of cold discomfort~     and vital signs were monitored.~      Mean core temperatures increased from 35.1°C (95% CI; 34.7-35.5 °C) to 36.0°C (95% CI;~     35.7-36.3 °C) (p<0.05) in patients assigned to passive warming only (n=22) and from 35.6°C~     (95% CI; 35.2-36.0 °C) to 36.4°C (95% CI; 36.1-36.7°C) (p<0.05) in patients assigned to~     additional active warming (n=26) with no significant differences between the groups. Cold~     discomfort decreased in 2/3 of patients assigned to passive warming only and in all patients~     assigned to additional active warming, the difference in cold discomfort change being~     statistically significant (p<0.05). Patients assigned to additional active warming also~     presented a statistically significant decrease in heart rate and respiratory frequency~     (p<0.05).~      In mildly hypothermic trauma patients, with preserved shivering capacity, adequate passive~     warming is an effective treatment to establish a slow rewarming rate and to reduce cold~     discomfort during prehospital transportation. However, the addition of active warming using a~     chemical heat pad applied to the torso will significantly improve thermal comfort even~     further and reduce the cold induced stress response.~   "
165448|NCT01400139|"~     The primary objective of this study is to characterize the long-term safety of Hydrocodone~     Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and~     nonneuropathic pain.~   "
165449|NCT01400126|"~     We wish to compare the effect of very clean water used for dialysis therapy (i.e ultrapure~     water) in comparison with the use of conventional water which are used in most dialysis units~     worldwide. To the best of our knowledge prospective data in that field is sparse.~   "
165450|NCT01400113|"~     Our proposal is to administer asenapine to patients who are clinically agitated and in need~     of immediate intervention. At present there are no controlled studies that we know of that~     explores the use of asenapine for this purpose. Establishing the utility of asenapine for~     this common clinical problem will support its use as an additional treatment option in~     acutely agitated patients.~   "
165451|NCT01400100|"~     The aim of the study is to test the hypothesis that intraarterial bolus application of 500 µg~     Octreotide in the gastroduodenal artery during the resectional phase of pancreatoduodenectomy~     in patients with soft pancreatic tissue hardens the texture of the pancreatic remnant.~      A primary end-point of the study is a change in pancreatic texture.~      A secondary end-point is the rate of postoperative pancreatic fistula.~   "
165452|NCT01400087|"~     The aim of this prospective randomized controlled trial is to assess the efficacy of~     cap-attached colonoscopy to improve cecal intubation in comparison with regular colonoscopy~     for trainees.~   "
165453|NCT01400074|"~     In this study, the efficacy of nilotinib at 400 mg BID will be compared with imatinib at 400~     mg BID in suboptimal molecular response patients. To determine study eligibility, suboptimal~     molecular response will be defined as patients who have achieved a complete cytogenetic~     response (CCyR) but have not achieved a MMR, after at least 18 months of treatment on first~     line imatinib therapy at a minimum dose of 400mg daily (Baccarani 2006).~   "
165454|NCT01400061|"~     According to our experimental experiences w hypothesized that blood boron levels may be~     corralated to body mass index.~   "
165455|NCT01400048|"~     The purpose of the present study is to study the effect of aloe vera in the treatment of IBS~     patients in a randomized, double-blind placebo controlled study.~   "
165456|NCT01400035|"~     Trial Title：The treatment of Vinpocetine（Cavinton）in patients with cerebral infarction, an~     open, randomized, multi-center control study~        1. Objectives Evaluate the efficacy and safety of Vinpocetine（Cavinton）for treatment of~          cerebral infarction~        2. Design Open, randomized, multi-center control study~        3. Trial Population:Patients with acute cerebral infarction~        4. Number of Subjects 720 patients in test group and 240 patients in control group, totally~          960 patients will be recruited.~        5. Administration Test group: intravenous infusion drip of Vinpocetine 30 mg and Citicoline~          0.4g once daily; additionally oral take aspirin 75-100mg or clopidogrel sulfate tablets~          75mg once a day.~           Control group: intravenous infusion drip of Citicoline 0.4g once daily; additionally~          oral take aspirin 75-100mg or clopidogrel sulfate tablets 75mg once a day.~        6. Outcome evaluation 6.1 Primary end points: 6.1.1 Modified Rankin Scale. 6.1.2~          Mini-Mental State Examination (MMSE) 6.2 Second end points 6.2.1 Barthel index 6.2.2~          NIHSS score 6.2.3 Transcranial Doppler (TCD) examination 6.3 Safety data 6.3.1 Serology,~          hepatic and renal function examination 6.3.2 Adverse events~        7. Statistical Analysis: SPSS 11.0 will be used to make the data analysis.~   "
165457|NCT01400022|"~     Lichen sclerosus is a rare, chronic cutaneous disorder with a predilection for the genital~     area. Any age group may be affected, although it is seen more often in postmenopausal women.~     The current gold standard treatment is topical ultrapotent corticosteroids such as~     clobetasol.~      Here we compare UVA1 phototherapy with 0,05% clobetasol propionate in vaseline for the~     treatment of vulvar lichen sclerosus.~   "
165458|NCT01400009|"~     Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin~     medications that have caused muscle pain for them in the past.~   "
165459|NCT01399996|"~     In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium~     animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or~     after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time);~     2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human~     volunteers. In addition to providing information about the relative efficacy of the delivery~     vehicles on probiotic function it will provide novel information about the influence of the~     yogurt smoothie alone (control) on all the parameters measured.~   "
165460|NCT01399983|"~     The 6 minute walk (6MW) gives information about the exercise capacity and it is an important~     tool for clinical decisions and for the prognostic evaluation of PH patients. The test is~     technically simple to perform, inexpensive and reproducible. During the 6MW O2 saturation,~     heart rate, walking distance (in this study after every minute) and the level of dyspnea~     (BORG-dyspnea scale) may be recorded; however, at present, mainly the walking distance is~     evaluated. The test is sometimes criticized, because of the dependence on the patient's~     motivation.~      The purpose of the present study is to standardize the test by the incorporation of objective~     factors. The investigators are correlating the change of heart rate and dyspnea (BORG scale)~     with the achieved walking distance during subsequent examinations performed with different~     effort.~   "
165461|NCT01399970|"~     The purpose of the present study is to determine whether a mobile teledermatology care model~     can achieve better clinical outcomes as compared to conventional, outpatient care for the~     management of severe acne treated with isotretinoin.~      The superiority of mobile care in comparison to conventional, outpatient care will be~     investigated regarding~        1. effectiveness: Global evaluation Acne (GEA) score -response at week 24~        2. safety: drop out rates and medication side effects~        3. overall patient satisfaction with acne care and therapy~        4. overall physician satisfaction with mobile acne care~   "
165462|NCT01399957|"~     Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in~     persons with multiple sclerosis. This project seeks to determine if there are other benefits~     to taking dalfampridine besides an increase in walking speed. This is strictly an~     observational study and research staff will not be involved in any decisions to stop or start~     taking the medication.~   "
165463|NCT01399944|"~     This single-site, within-subject, experimental study is designed to test the hypothesis that~     individuals express taste receptors differently and have different sensitivities to bitter~     taste samples, which results from uneven expression. Subjects will include 100 racially and~     ethnically diverse, healthy adults. All subjects will provide saliva samples for genetic~     analysis and undergo taste testing with common psychophysical stimuli. From the pool of 100~     subjects, 36 subjects from the common heterozygous group (PAV/AVI) and two from each~     homozygous group (AVI/AVI, nontaster and PAV/PAV, taster) will be invited to return for two~     additional sessions. During both sessions the investigators will 1) measure bitterness~     thresholds for PROP, a common psychophysical stimulus; 2) measure bitterness perception of~     several vegetables; 3) obtain a saliva sample and 4) collect taste papillae. The~     investigators will then isolate DNA and RNA from the taste papillae and isolate DNA from~     saliva to evaluate molecular differences over time and between individuals and how it relates~     to taste psychophysics. All psychophysical and cellular measurements will be done during both~     sessions so that the investigators can determine how much variation is observed over a~     one-week time period in both cellular phenotype and psychophysical phenotype.~   "
165464|NCT01399931|"~     To assess specificity and overall accuracy of interim dual-point acquisition PET in~     predicting treatment outcome.~      The study is aimed at assessing the specificity of interim dual-point PET performed after 2~     ABVD cycles to predict treatment outcome in early-stage Hodgkin's Lymphoma patients~     presenting bulky lesions at baseline.~   "
165465|NCT01399918|"~     The purpose of this study is to find out what effects, good and/or bad the combination of two~     medications, everolimus and bevacizumab, has on kidney cancer. In this clinical trial we are~     now testing these medications in combination. We think that both together might work better~     that either drug alone. Importantly, both of these drugs together have been tested in~     patients with a different type of kidney cancer and patients tolerated the combination well.~   "
165466|NCT01399905|"~     Hypothesis: We hypothesize that carbidopa in daily doses of 450mg will enter the central~     nervous system and partially inhibit AAAD, thereby reducing the decarboxylation of exogenous~     levodopa to dopamine, and thereby blunt the therapeutic effects of levodopa in PD subjects.~      The purpose of this study is to see how low dose vs. high dose of the study drug, carbidopa~     effect movement in subjects with Parkinson's disease. The low dose of the study drug is 75 mg~     and the high dose is 450mg.~      Subjects will be recruited from the investigators clinic when they are seen for treatment for~     Parkinson's disease. Subjects will also be recruited through flyers hung at OHSU and at the~     VA.~      Subjects will take part in 2 screening visits one week apart to determine eligibility.~     Subjects will be randomly chosen to start either high or low dose carbidopa and take it for 4~     weeks. Subjects will be called 2, 4, and 6 or 7 days after this visit to ask how they are~     doing after starting this dose of study drug. We will leave them a message if we cannot reach~     them. If there are any problems, we will schedule them to come to the clinic within the next~     2 days.~      Subjects will have an outpatient visit 2 weeks after screening and a hospital admission 2~     weeks after that. At the hospital, subjects will stay for 3 days. They will have blood drawn~     and their Parkinson's disease assessed by a finger tapping exercise, timing their walking,~     and looking at their uncontrolled movements.~      The subject will then receive the opposite dose of carbidopa for 4 weeks. Subjects will be~     called 2, 4, and 6 or 7 days after this visit to ask how they are doing after starting this~     dose of study drug. We will leave them a message if we cannot reach them. If there are any~     problems, we will schedule them to come to the clinic within the next 2 days.~      The outpatient visit and hospital admission will repeat again. At the end of the second~     hospital admission, treatment on the study is over and subjects will go back to their~     original Parkinson's disease medications. The study will end with a follow up phone call or~     clinic visit 2 - 4 weeks after the final hospital admission.~      Subjects will fill out a daily diary that asks about their movement throughout the day for 3~     days before they come to the Oregon Clinical and Translational Research Institute.~      Carbidopa is used for the treatment of Parkinson's disease with levodopa. This protocol is~     using a high dose of 450mg of carbidopa. This study is also using IV levodopa, which is a~     different route than is normally given.~      Finger tapping rates will be compared between high and low dose study drug use to see if one~     group has slower rates than the other.~   "
165467|NCT01399892|"~     High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition~     Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay~     glucose absorption and reduce postprandial glycemic excursion. They also appear to have a~     beneficial effect on cholesterol levels. It has been shown, in few short term adult studies,~     that high fiber foods reduce postprandial blood glucose levels. The American Diabetes~     Association feels that there is little evidence confirming the positive effect of high fiber~     foods on blood glucose control. It is not clear whether a high fiber diet can improve~     glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that~     children with type 1 diabetes will benefit from having added fibers in their diet. The~     investigators plan to study blood glucose values using a continuous blood glucose monitor~     before and after dietary fibers are introduced. This will help us determine whether a diet~     rich in fiber should be recommended in all children with type 1 diabetes mellitus~   "
165468|NCT01399879|"~     The Scanning Kelvin Probe measures surface electrical potential without actually touching the~     skin. This is a pilot study to evaluate methods of minimizing noise during Scanning Kelvin~     Probe measurements. This project will focus specifically on noise arising from physical~     movement and environmental electrical field.~   "
165469|NCT01399866|"~     One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60 to~     a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to~     prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion criteria,~     and demonstrate response to cue reactivity at the screening visit, will either be:~        -  started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose~          of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which~          method to use to quit smoking will be based on participant choice as well as taking into~          account any medical contraindications to either therapy.~        -  evaluated to confirm abstinence from smoking. Recently abstinent participants referred~          by a smoking cessation clinic, PCP or self referred must have an expired air CO < 10 ppm~          to confirm abstinence.~      Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue~     Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study~     medication and cue exposure treatment, spaced five to nine days apart. Subjects will complete~     2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire study~     involves twelve visits and will last approximately ten weeks. For recently abstinent~     participants referred by a smoking cessation clinic, PCP or self referred, the study involves~     7 visits (screening and baseline visit will be merged into one and there is no CBT component)~     and will last approximately 7 weeks.~   "
165470|NCT01399853|"~     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused~     by viruses that belong to the enterovirus genus of the picornavirus family. Although most~     HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71~     (EV71) can present with a high rate of neurological complications, including~     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by~     EV71 has become a major emerging infectious disease in Asia and the highly pathogenic~     potential of EV71 clearly requires the attention of world medical community.~      The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in~     Jiangsu Province in China. The data from the phase I study suggested that the inactivated~     EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese~     children and infants. In order to provide more evidence for the immunogenicity of the~     vaccine, to further explore the probable immunizing dose and the safety profile of this~     vaccine, a phase II clinical trial is planed to conduct.~   "
165471|NCT01399840|"~     This is a two-arm, open-label study to determine the maximum tolerated dose (MTD) and assess~     the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BMN 673 in~     patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic~     Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL). Arm 1 will enroll patients with~     either AML or MDS; Arm 2 will enroll patients with either CLL or MCL.~   "
165472|NCT01399827|"~     The purpose of this study is to a) assess the efficacy of omega-3 fatty acids in the~     treatment of Deficient Emotional Self-Regulation (DESR) among stimulant treated Attention~     Deficit Hyperactivity Disorder (ADHD) adults, b) assess the side effect profile of omega-3~     fatty acids in the treatment of DESR among stimulant treated ADHD adults, c) assess effects~     of omega-3 fatty acid supplementation on ADHD symptoms and associated features in stimulant~     treated ADHD adults, and d) predict value of fatty acids present in RBC cell membranes. This~     study will be a 12-week trial with adults 18-55 years of age with ADHD and symptoms of DESR.~   "
165473|NCT01399814|"~     The purpose of this study is to find out whether perioperative fluid restriction influence on~     postoperative immunological function. And discuss the probable mechanism that fluid~     restriction regime effect on clinical data.~   "
165474|NCT01399801|"~     The purpose of this study is to determine if optimal lead placement, guided by the largest~     improvement in aortic flow measured by Doppler will:~        1. Improve the way the heart's left ventricle functions~        2. Decrease the number of hospital admissions for heart failure related symptoms~        3. Reduces uncoordinated heart contractions~        4. Improve quality of life as measured by the Minnesota Living with Heart Failure~          Questionaire and NYHA Class assessed after six months~   "
165475|NCT01399788|"~     This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against~     reference drug in healthy volunteers.~   "
165476|NCT01399775|"~     1. Evaluation of dimensional changes in alveolar ridge following immediate implantation~          compared to delayed implantation~        2. evaluation of the effect of gap dimensions between socket walls and dental implant in~          implant stability~   "
165477|NCT01399762|"~     The purpose of the Endostroke Registry is to gather information on predictors of good or poor~     clinical outcome following mechanical recanalization therapies for acute ischemic stroke.~   "
165478|NCT01399749|"~     The objective of our study is to compare the safety and effectiveness of the use of~     autologous cultured adipose tissue-derived stem cells versus cultured autologous chondrocytes~     for the treatment of chondral knee lesions.~   "
165479|NCT01399736|"~     The Compare-Acute trial is a prospective randomised trial in patients with multivessel~     disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The~     purpose of the study is to compare a FFR guided multivessel PCI taking place during the~     primary PCI with a primary PCI of the culprit vessel only.~      Patients will be enrolled after successful revascularisation of the culprit vessel. Patients~     that have at least one lesion with a diameter of stenosis of more than 50% on visual~     estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related~     artery, will be randomised either to the FFR guided complete revascularisation arm or staged~     revascularisation by proven ischemia or persistence of symptoms of angina.~      Approximately 885 patients will be entered in the study.~      Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting~     stenoses in the non-IRA performed within the same procedure as the primary PCI or within the~     same hospitalisation will improve clinical outcomes compared to the staged revascularisation,~     guided by prove of ischemia or clinical judgment, as recommended from the guidelines.~   "
165480|NCT01399723|"~     This study seeks to determine whether clinical outcome following initial treatment of severe~     pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin.~     The study will also provide an estimate of the proportion of Kenyan children with severe~     pneumonia who fail treatment with a single antibiotic.~   "
165481|NCT01399710|"~     RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is~     less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD)~     has shown promising results in providing uniform accuracy and improving CT colonography~     sensitivity.~      PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and~     CAD-assisted reading in detecting patients with colorectal lesions.~   "
165482|NCT01399697|"~     This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of~     RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra~     monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate.~     All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus~     oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be~     randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either~     methotrexate or placebo. Anticipated time on study treatment is 28 weeks.~   "
165483|NCT01399684|"~     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed~     to estimate the efficacy of MEGF0444A treatment to disease progression, combined with~     oxaliplatin + folinic acid + 5-Fluorouracil (mFOLFOX-6) + bevacizumab therapy in participants~     with metastatic colorectal cancer (CRC).~   "
165484|NCT01399671|"~     Major depression is characterized by vestibular anomalies. The investigators hypothesized~     that vestibular stimulation will improve depression symptoms in major depression patients.~   "
165485|NCT01399658|"~     Standard therapy for gynecologic cancers involves the use of brachytherapy, also called~     internal radiation therapy or implant radiation. The treatment being studied consists of~     standard brachytherapy with the additional use of MRI to guide the insertion of radioactive~     applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is~     practical and beneficial when compared to the standard CT-guided brachytherapy placement. The~     investigators are hoping that this MRI procedure will decrease the risk of giving too high a~     radiation dose to the bladder or bowel.~   "
165486|NCT01399645|"~     This study is conducted to test the hypothesis that in type 2 diabetic adults with fatty~     liver who are resistant to metformin, treatment with liraglutide in combination with~     metformin will cause an absolute reduction in liver fat superior to insulin-metformin~     treatment within a 3-month period, as measured by magnetic resonance imaging (MRI).~   "
165487|NCT01399632|"~     Generally, people with low levels of high-density lipoprotein (HDL) in blood are more likely~     to get heart disease than those who have normal or high levels. Dietary fat, whether the~     harmful type (saturated) or beneficial type (unsaturated) raises HDL levels. Dietary~     carbohydrate lowers HDL. The investigators are doing this research study to find out why the~     amount of HDL in a person's blood is affected by dietary unsaturated fat and carbohydrate.~     The investigators will trace the ability of the HDL in a person's blood to take up~     cholesterol, get bigger, and then leave the blood by passing into the liver. The~     investigators want to know if dietary unsaturated fat improves the ability of HDL to do this~     compared to dietary carbohydrate.~   "
165488|NCT01399619|"~     the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or~     24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation~     of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue~     PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or~     relapsers patients coinfected with HIV~   "
165489|NCT01399606|"~     This is a multicentric International Phase III,Long term open label study(12 months)assessing~     the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive~     Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.~   "
165490|NCT01399593|"~     The purpose of this trial was to determine the safety and efficacy of eculizumab in the~     prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor~     kidney transplant requiring desensitization therapy.~   "
165491|NCT01399580|"~     Prospective, Randomized, Double-Blind, Parallel Design, Placebo-Controlled Multicenter Study.~     The study objectives are to evaluate efficacy and safety, including thoracic bioimpedance, of~     once daily administration of atrasentan tablets (high dose and low dose) compared to placebo~     in type 2 diabetic subjects with nephropathy who are receiving the maximum tolerated labeled~     daily dose of a RAS inhibitor.~   "
165492|NCT01399567|"~     Pain assessment and management deficiencies in nursing homes (NHs) are well documented.~     Unrelieved pain in this setting results in poorer resident outcomes, including depression,~     decreased mobility, sleep disturbance, and impaired physical and social functioning. This~     randomized controlled trial will evaluate the efficacy of a pain management algorithm coupled~     with intense diffusion strategies in improving pain, physical function and depression among~     NH residents. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain~     management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain~     education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression~     among NH residents; 2) Determine the extent to which adherence to the ALG and organizational~     factors are associated with changes in resident outcomes and the extent to which changes in~     these variables are associated with changes in outcomes; 3) Evaluate the persistence of~     changes in process and outcome variables at long-term follow-up and 4) Evaluate the~     relationships among behavioral problems and pain in severely cognitively impaired residents~     who are unable to provide self-report.~   "
165493|NCT01399554|"~     Alcohol use disorders are common and few individuals with the disorder ever seek help. This~     study proposes to intervene in a novel way - exercise, as it has many mental and physical~     health benefits and is an activity that is incompatible with simultaneous alcohol use. If~     effective, this non-stigmatizing intervention may increase the utility and acceptability of~     interventions for alcohol use disorders and ultimately increase the number of individuals~     effectively treated.~   "
166729|NCT01383356|"~     The data from this study will be used to compare the kinetic profile of metformin 500mg in~     linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference~     product administered concomitantly with linagliptin 2.5 mg tablet.~   "
165494|NCT01399541|"~     The specific aims of this translational, interdisciplinary, multi-center, international~     research study with 300 Lung cancer patients are to:~      Aim 1 Explore how the patients experience the transfer between different locations and~     between different levels of care at the same location and how they experienced coming home.~      Aim 2 Explore lung cancer patients' symptoms, symptom clusters, and changes in symptoms and~     symptom clusters over time.~      Aim 3 Explore interaction between lung cancers patients' symptoms, symptom clusters, health~     related quality of life and social support.~   "
165495|NCT01399528|"~     This is an observational study exploring the genetics of lacosamide response. The study will~     last 3 years and has been divided in to three stages; 1) recruitment, 2) observational phase,~     3) genotyping and analysis. Patients initiating lacosamide are recruited and their baseline~     seizure frequency is assessed retrospectively. Patients are then monitored for 18 months with~     an assessment (via interview and where possible seizure diaries) of seizure frequency and~     other treatment related phenotypes every 3 months. The recruitment period will span months~     1-12, the observational period will span months 1-30 and analysis of data will be conducted~     between months 30-36 (see Figure 2 below). Target sample size is 610.~      Primary objective: To determine the clinical relevance of genetic variation in predicting~     lacosamide responsive and non-responsive patients.~      Secondary objectives: To determine the clinical relevance of genetic variation in predicting:~        -  Optimal dose of lacosamide~        -  Adverse drug reactions to lacosamide~   "
165496|NCT01399515|"~     The purpose of this study is to evaluate the efficacy and safety of oral valproic acid to~     slow the progression of visual function and/or to improve the visual function in patients~     with retinitis pigmentosa (RP).~      Enrolled subjects in valproic acid group will be treated with oral valproic acid 500mg daily~     for 48 weeks. Visual function and safety will be assess before and after treatment (48 weeks)~     between valproic acid and control groups.~   "
165497|NCT01399502|"~     The purpose of this study is to investigate the effectiveness of health promotion emails for~     depression. It is hypothesised that emails containing self-help advice will improve~     depression symptoms more than emails containing information about depression.~   "
165498|NCT01399489|"~     The current study is designed to examine the impact of 16 weeks of moderate intensity aerobic~     training on arterial stiffness and blood pressure in stage 3 chronic kidney disease (CKD)~     patients. The investigators hypothesize that short term aerobic training will improve the~     stiffness of arteries in CKD patients.~   "
165499|NCT01399476|"~     This is a study of the safety and efficacy of a new surgical procedure using endoscopic~     instruments and a tunneling technique to reach the LES for dissection. We hypothesize that~     this technique provides an incisionless, less invasive option with similar functional outcome~     compared to standard Heller myotomy.~   "
165500|NCT01399463|"~     The aim of the study is to show the safety and efficacy of the SeQuent® Please (Drug Eluting~     Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel~     disease and side branches by pressure wire guided percutaneous coronary intervention.~   "
165501|NCT01399450|"~     The purpose of this study is changing (improving), after initiating various doses of~     Paliperidone ER on schizophrenia patients.~   "
165502|NCT01399437|"~     Background:~      - A special brain circuit is important for helping us keeping an eye open for things that are~     going on around us, even when we are not directly paying attention to them. This circuit~     seems to work differently in people with schizophrenia than in other people, which may~     explain specific deficits with broad monitoring observed in people with schizophrenia.~     Researchers want to compare brain function in people with schizophrenia and healthy~     volunteers to find out more about how these brain circuits work and affect attention.~      Objectives:~      - To study how the brain performs broad visual monitoring in people with schizophrenia.~      Eligibility:~        -  Individuals between 18 to 55 years of age who have been diagnosed with schizophrenia.~        -  Healthy volunteers between 18 and 55.~      Design:~        -  Participants will be screened with physical and psychological exams. They will have a~          medical history. Tests for drug and alcohol use will also be done.~        -  Participants will have two study visits. The first is a training visit and the second is~          a scanning visit.~        -  At the training visit, participants will practice computer-based tests of focus, memory,~          and concentration. They will also answer questions about mood, psychiatric symptoms, and~          smoking habits.~        -  At the scanning visit, participants will perform the computer-based tasks that they~          practiced at the training visit. They will have magnetic resonance imaging while they~          perform these tasks.~   "
165503|NCT01399424|"~     The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a~     saccharide-protein conjugate composed of a fragment of S. sonnei LPS. The saccharide~     component consists of an average of 3.5 repeat units of the O-SP plus the core region of the~     LPS (O-SPC). The O-SPC is covalently bound to the non-toxic recombinant diphtheria toxin~     mutant (rDT).~      The objective of this phase of the study is to determine if this vaccine is safe and can~     induce IgG antibody type-specific immunity to shigellosis in adults. The overall objective is~     to determine if this vaccine can elicit higher levels of IgG antibody than the previous~     experimental vaccines made with the full length O-SP, shown to be > 70% efficacious in~     greater than or equal to 3 year old children. Higher levels of IgG anti O-SP are expected to~     induce type specific immunity to shigellosis in younger children.~      Sixty 18-49 years-old healthy adults will be recruited in Israel. Volunteers will be~     vaccinated on a random basis with one i.m. injection of 10 or 25 ug of the investigational~     conjugate vaccine. Local and systemic reactions will be observed at 30 minutes, and the~     volunteers will be instructed to take their temperature and examine the injection site for~     redness and swelling and fill out a questionnaire at 6, hours and daily for 7 days after~     vaccination. The volunteers will visit the clinic at 24 or 48 hours following the injection~     and any time they request it. The study will commence with 5 volunteers injected with the~     10ug dose to be followed, if no severe adverse reactions occur, by 5 volunteers injected with~     the 25ug dose. If a severe adverse reaction occurs on 1 of the 5 volunteers in either group,~     5 more will be injected with that dose. If there are no severe adverse reactions the study~     will proceed. If there is one more severe reaction the study will be halted and re-evaluated~     by the IRB and the FDA.~      Vaccine-induced antibodies will be measured at 1 and 6 months after immunization, and~     compared to those elicited by our previous S. sonnei conjugate vaccines.~      There is a body of evidence that a critical level of serum IgG antibody to the O-specific~     polysaccharide domain of LPS confers type-specific immunity to S. sonnei as well as to other~     Shigella:~        1. Shigellosis is rarely observed in infants up to the age of 4-6 months. The most obvious~          explanation for this is that maternally-derived serum IgG provides this immunity;~        2. There is an age-related development of IgG anti-LPS antibodies that, in many instances,~          is not induced by the homologous bacteria but by non-pathogenic cross-reacting enteric~          bacteria;~        3. The highest incidence, morbidity, and mortality occur during 6 months to 6 years of age~          when the maternally-derived serum anti-O-SP has waned and the naturally-derived~          antibodies have not yet appeared;~        4. One injection of a S. sonnei-rEPA conjugate showed significant protection against~          shigellosis in Israeli Defense Force soldiers. Vaccinees who developed shigellosis~          showed significantly lower serum IgG responses to the homologous LPS than those did~          not.The high antibody level induced by the conjugate vaccine indicates the positive~          correlation between the serum IgG anti-LPS levels and immunity to S. sonnei infection;~        5. Following Phase 1 and Phase 2 studies that showed safety and age-related immunogenicity,~          a double-blinded randomized and vaccine-controlled Phase 3 evaluation of S. sonnei and~          S. flexneri type 2a O-specific polysaccharide (O-SP) protein conjugates was conducted~          among 1-4 year-olds in Israel.~      For recipients of the S. sonnei conjugate 71.1% efficacy was shown among 3-4 year-old~     recipients, no efficacy was shown for recipients of S. flexneri 2a. There was no~     statistically significant efficacy for either vaccine in the 1-3 year-olds. Levels of serum~     IgG anti-O-SP were elevated according to the vaccine the children received but G.M. levels~     declined rapidly several months after the last injection. Our interpretation is that the~     age-related efficacy of the Shigella conjugates was due to the conjugate-induced O-SP~     antibody levels. Accordingly, we have developed a method to increase the immunogenicity of~     the conjugates to approach the antibody levels of Israeli soldiers shown to be protected by~     our S. sonnei O-SP.~      Low-molecular-mass O-SP-core (O-SPC) fragments were isolated from S. sonnei LPS, and bound by~     their reducing ends to the carrier protein. The O-SPC conjugates used oxime linkages between~     the terminal Kdo residues at the reducing ends of the S. sonnei saccharides and aminooxy~     linkers bound to the carrier. The coupling reaction was carried out at a neutral pH and room~     temperature. The carrier protein was a non-toxic recombinant diphtheria toxin mutant. IgG~     antibody levels induced in young outbred mice by this new S. sonnei O-SPC conjugate were~     significantly higher then those elicited by the O-SP conjugates.~   "
165504|NCT01399411|"~     Background:~      - The Agricultural Health Study (AHS) is looking at the long-term health effects of farming~     exposures including pesticides, crops, and animals. The chronic health effects of exposure to~     pesticides are easier to study in farmers and their spouses. They know what chemicals they~     use and tend to live in the same place for most of their adult lives. AHS participants are~     expected to report any changes in their health. This includes any new medical conditions.~     Researchers want to follow up on these reports to confirm their accuracy.~      Objectives:~      - To follow up AHS participants who have self-reported that they have a new disease and~     confirm their diagnosis.~      Eligibility:~      - Current AHS participants.~      Design:~        -  Researchers will confirm self-reported changes in medical conditions by contacting the~          AHS participant to ask for more information.~        -  The AHS participant will give permission for researchers to contact their doctor to look~          at their medical records. They will also be asked to provide a cheek swab or saliva~          sample.~        -  Diseases of interest are rheumatoid arthritis, lupus, and Sjogren s Syndrome. Other~          diseases will be followed up in the future. Other diseases will be followed up in the~          future.~   "
165512|NCT01399307|"~     Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large~     therapeutic potential for many rare and common diseases that impacts millions of patients~     worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to~     extract with minimally invasive procedures such as elective liposuction in large quantities~     and therefore may be a cost effective source for cellular therapies in a wide range of~     medical specialties. In this study we aim to demonstrate the efficacy of Antria Cell~     Preparation Process© in obtaining human adipose derived Stromal Vascular Fraction (SVF) by~     performing histology, various cell counts, multiple surface marker tests and measurement of~     the residual amount of digestive enzymes as a safety measure for human clinical trials.~   "
165505|NCT01399398|"~     Background:~      - The cannabinoid type 1 (CB1) receptor is a protein found on some brain cells. It may play a~     role in obesity or some psychiatric disorders such as schizophrenia. Imaging studies like~     positron emission tomography (PET) can show where CB1 receptors are located. A new~     radioactive chemical, 11C-SD5024, may be able to show these receptors more clearly than~     previous radioactive chemicals. Better images of CB1 receptors in the brain may help improve~     our understanding of obesity and psychiatric disorders. This information may lead to better~     treatments.~      Objectives:~      - To test how well a new radioactive chemical, 11C-SD5024, is taken up by the brain during~     imaging studies.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age who are able to have positron emission~     tomography scans.~      Design:~        -  All participants will be screened with a physical exam, medical history, and blood~          tests.~        -  Participants will be in one of three groups for the study. Each group will receive~          11C-SD5024 and have a different set of imaging studies.~        -  Group 1 will have a magnetic resonance imaging (MRI) scan and PET scan of the brain.~          They will also have blood and urine tests.~        -  Group 2 will have a whole-body PET scan, as well as blood and urine tests.~        -  Group 3 will have an MRI scan of the brain, followed by two PET scans of the brain. They~          will also have blood and urine tests. The two PET scans can happen on the same day or on~          two different days.~   "
165506|NCT01399385|"~     Background:~      - Imaging tests, such as magnetic resonance imaging (MRI), can provide information about~     heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing~     and vessel wall thickness. This information may help diagnose and treat heart disease and~     other conditions that lead to heart attacks. Better MRI methods are needed to improve heart~     disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new~     techniques to improve the quality of heart MRI, compared with more complex studies like~     catheterization or angiography.~      Objectives:~      - To compare heart MRI techniques with other tests used to diagnose heart disease.~      Eligibility:~      - People at least 18 years of age who either have or may have heart disease, or are healthy~     volunteers.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~        -  They will have an angiography to study the inside of blood vessels. This test is an~          x-ray study of the blood vessels. It will be done either separately or as part of a set~          of tests to diagnose possible heart disease.~        -  Participants will have at least one and up to five MRI scans. The scans will involve~          different methods of studying the heart and blood vessels. Participants may also have a~          computed tomography scan to confirm the findings of an MRI scan.~        -  No treatment will be provided as part of this protocol.~   "
165507|NCT01399372|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.~     Others interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy, such as methotrexate, vincristine sulfate, procarbazine hydrochloride, and~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill~     cancer cells. It is not yet know whether rituximab and combination chemotherapy are more~     effective when given with or without radiation therapy in treating patients with primary~     central nervous system lymphoma.~      PURPOSE: This randomized phase II trial studies how well giving rituximab and combination~     chemotherapy with or without radiation therapy works in treating patients with primary~     central nervous system lymphoma.~   "
165508|NCT01399359|"~     RATIONALE: Learning about how patients make decisions about using chemoprevention may help~     doctors plan treatment in which more patients are willing to choose chemoprevention to reduce~     their breast cancer risk.~      PURPOSE: This clinical trial studies factors influencing decision-making about the use of~     chemoprevention in women at increased risk for breast cancer.~   "
165509|NCT01399346|"~     Rationale: For the development of a closed loop system, faster insulin absorption after bolus~     administration could help to reduce the system's delay and thus increase patient safety. It~     has been shown that regular insulin absorption is faster when injecting insulin with a~     sprinkler needle (containing holes in the walls and being sealed at the tip). The current~     study will evaluate the impact of different application volumes on pharmacokinetic and~     pharmacodynamic properties of rapid acting insulin analogue (insulin aspart).~      Objective: To compare the pharmacokinetic response (based on the time to maximum observed~     serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart~     after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in~     patients with type 1 diabetes.~      Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study.~      Population: Twelve type 1 diabetic subjects~      Intervention: The investigational treatment is the subcutaneous administration of insulin~     aspart either as one bolus of 18 IU at one injection site or as 9 separately and~     simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma~     samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an~     8-hour clamp experiment. Patients will undergo both investigational treatments in a~     randomized order; between the two clamp visits there will be a wash-out period of 5-21 days.~      Main study endpoint: Time to maximum observed serum insulin aspart concentration.~   "
165510|NCT01399333|"~     The purpose of this research study is to compare the varying qualities of protein supplements~     utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) method and evaluating~     the clinical outcome related to protein stores and absorption.~   "
165511|NCT01399320|"~     Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety~     of problems, including infection/abscess and the development of a chronic sinus cavity.here~     we try a minimmally invasive method for managing such condition~   "
165524|NCT01399151|"~     Hypothesis:~      Volunteers with vitamin D insufficiency (serum 25(OH)D 25-50 nmol/L) given intermediate or~     high dose vitamin D supplements (2,000 or 5,000 IU per day) will have increased production of~     anti-bacterial peptides and interleukin-1, decreased production of other pro-inflammatory~     cytokines, increased production of regulatory cytokines and an enhanced T- and B-cell~     response to a tetanus vaccine compared to vitamin D insufficient subjects given low dose~     vitamin D supplements (400 IU per day).~   "
165525|NCT01399138|"~     The purpose of this study is to examine the effects of a blueberry powder on insulin~     sensitivity, blood pressure, and vascular reactivity in subjects with metabolic syndrome.~   "
165513|NCT01399294|"~     Constipation is a common problem in palliative cancer patients. However, there were~     insufficient randomized controlled trial (RCT) data to identify the best laxative or~     combination of laxatives in these patients.~      Traditional Chinese medicine (TCM) in holistic approach is popular among cancer patients.~     More than half had received at least one form of TCM therapy according to the survey carried~     in 2008. Chinese herbal medicine (CHM) in compound formulation with nourishing and purging~     effects simultaneously may be more preferred to relieve constipation by local palliative~     cancer patients.~      TCM syndrome differentiated by collecting all symptoms and signs through the classic four~     diagnostic methods is the foundation for making diagnosis and prescription in TCM practice.~      The present study is the first local study to evaluate the bowel habits and TCM syndrome of~     advanced cancer patients with constipation. We hope that the results not only can shed light~     on patient's own reporting or experience of constipation and the effectiveness of current~     practice, but also can draw up a CHM formulation for advanced cancer patients with~     constipation.~   "
165514|NCT01399281|"~     BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common chronic paediatric~     rheumatic disease (PRD) and an important cause of short and long-term disability. Although~     none of the available drugs for JIA has a curative potential, prognosis has greatly improved~     as a result of substantial progress in disease management. The therapeutic treatment of~     children with JIA encompasses the use of NSAIDs and intra-articular steroid injections. In~     those patients not responding to NSAIDs, methotrexate (MTX) has become the disease modifying~     anti-rheumatic drug (DMARD) of first choice worldwide. For children not responding to MTX,~     biologic agents recently have become treatment options.~      PATIENTS AND METHODS: 3-10 year observation study related to children with JIA undergoing~     treatment with MTX or biologic agents with the following objectives:~        1. To create a long-term observational registry of a large population of prevalent and~          incident cases.~        2. Use the accumulating data in the registry to conduct (i) a pharmacovigilance/safety~          study (primary endpoint) and (ii) estimate effectiveness (frequency and magnitude of~          response, disease activity over time inhibition or slowing of joint erosions and other~          radiological evidence of disease progression,), and (iii) estimate adherence to the~          various treatment regimens. Data from the registry will be used to compare safety and~          effectiveness profiles amongst the patient cohorts.~        3. To identify clinical and laboratory predictors of safety, response to therapy, including~          remission This project has retrospective (first 3 years) and prospective components (up~          to 10 years) and will be conducted by the participating centres of the more than 50~          countries belonging to the Paediatric Rheumatology INternational Trials Organisation~          (PRINTO certified ISO 9001-2008, www.printo.it), or the Pediatric Rheumatology European~          Society (PRES at www.pres.org.uk). The main role of these organisations is to provide a~          scientific basis for current treatments of paediatric rheumatic diseases.~      The overall hypothesis to be tested is:~      • Biologic agents ± MTX agents are able to maintain an acceptable safety profile in the long~     term in children with different JIA categories while achieving clinical remission and~     prevent/stop joint erosion development over time.~      The overall aims are to establish the long term safety of biologic agents and MTX, and their~     relative effectiveness in children with JIA who need treatment with second line agents.~   "
165515|NCT01399268|"~     Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a~     major marker of inflammation is known to increase during total joint replacement surgery. IL6~     has been found to be elevated postoperatively in patients with hip fractures and has been~     linked to mental status changes and possibly other complications. It is known to lead to~     shock and participate in the inflammatory state seen in sepsis. High levels have further been~     linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress~     syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low~     dose steroids given in two doses in the initial perioperative period decreased the amount of~     IL6 released compared to placebo, but this was not sustained past 24 hours.~      Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in~     urine samples. It is considered to be a marker of lung injury and is found to be elevated in~     patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the~     investigators have found that urine desmosine levels rise with bilateral total knee~     replacement compared to unilateral total knee replacement indicating possible lung injury.~      Therefore the investigators hypothesize:~      Continued low dose steroids given three times over a 24 hour period will:~        1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement~          and maintaining this reduction in IL6 beyond 24 hours.~        2. Decrease urinary desmosine levels, and hence be protective of lung injury.~   "
165516|NCT01399255|"~     The aim of this study is to assess the bioequivalence of two rapid-acting insulin Lispro~     formulations: Humalog® and Listro™ in healthy subjects based on the pharmacokinetic parameter~     (PK) and the pharmacodynamic parameter (PD).~   "
165517|NCT01399242|"~     The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus~     corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic®~     plus corticosteroids as measured by the change in calculated Glomerular Filtration Rate~     (cGFR) from baseline to month 12.~      The key secondary objective is to demonstrate non-inferiority of biopsy-proved acute~     rejection (BPAR), graft loss, death or loss to follow-up (composite endpoint) at month 12 in~     patients switched to everolimus plus Myfortic® plus corticosteroids following CNI withdrawal~     at Week 16 compared to patients maintained on tacrolimus plus Myfortic® plus corticosteroids.~      Patients will be submitted to monthly GFR determination but, for group comparison, only the~     GFR measured at month 12 and month 24 of renal transplantation will be used.~   "
165518|NCT01399229|"~     This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor®~     (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term~     pregnant patients.~   "
165519|NCT01399216|"~     We aim to determine whether a supplement containing fucoidan isolated from Mekabu (sporophyll~     of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body temperature in~     subjects with low basal body temperature.~   "
165520|NCT01399203|"~     To investigate the predictive value of the contrast media volume to creatinine clearance~     (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and~     to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI~   "
165521|NCT01399190|"~     This prospective observational study will evaluate the efficacy and safety of bevacizumab in~     combination with capecitabine and oxaliplatin as first-line treatment in participants with~     colorectal cancer. Data will be collected from each participant until disease progression~     occurs (for up to 30 months).~   "
165522|NCT01399177|"~     The purpose of this study is to find out if there is any change in diet on food cravings and~     weight loss in the 12 months following bariatric surgery.~   "
165523|NCT01399164|"~     To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in~     subjects with proton pump inhibitor induced achlorhydria.~   "
165526|NCT01399125|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon®~     patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory~     submission and registration of Exelon transdermal patch in China. The study is designed to~     confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus~     Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease~     Assessment Scale-Cognitive Subscale (ADAS-Cog).~   "
165527|NCT01399112|"~     The investigators propose to recruit patients who have experienced a recent first episode of~     psychosis who have a chart diagnosis of Schizophrenia, Schizophrenifom, Schizoaffective~     Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features and self identify~     themselves as a current cigarette smoker. Aiding this population with smoking cessation is~     crucial as the majority of people with schizophrenia spectrum disorders (50-90%) smoke, which~     is leading to early mortality. While these individuals can benefit from standard~     evidence-based treatment, these treatments are underutilized. Web based programs, such as the~     EDSS and thetruth.com, can provide education and motivational tools to help people with a~     recent onset of psychosis use evidence-based smoking cessation treatments. This study aims to~     test these two web-based programs among young people with a recent episode of psychosis for~     usability and likeability and to explore whether use of these two programs will motivate~     users to seek smoking cessation treatment or to engage in other quitting behaviors in the~     month following use of the programs. Information gathered from this proposal will be used to~     help the researchers decide whether either of these two programs will be reasonable to~     include in a larger study of a comprehensive treatment for individuals with first episode~     psychosis.~   "
165528|NCT01399099|"~     Neodyne has developed an investigational dressing for post-operative incision care. Neodyne~     is conducting this research to study whether the investigational dressing, called the Neodyne~     Dressing, can minimize scar formation in a simple manner.~   "
165529|NCT01399086|"~     This is a retrospective chart-review study that will be based on the collection of data from~     electronical or paper-based medical records with available data on patients who have~     commenced treatment with fulvestrant after January 1st of 2007. All necessary information for~     the purposes of the present study will be collected with the use of a paper-Case Record Form.~   "
165530|NCT01399073|"~     Compared to the classical paper and pencil-tests, testing patients in our virtual reality~     setup might have a higher sensitivity and specificity.~   "
165531|NCT01399060|"~     This single-site, within-subject, experimental study is designed to test the hypothesis~     children who live in a household in which one or both of their parent smoke will exhibit a~     higher cough threshold and will prefer more intense sweet tastes than children who live in a~     household where neither parent smokes. Subjects will include at least 50 racially and~     ethnically diverse, healthy children aged 10 to 17 years (a critical time for experimenting~     with tobacco) and a parent. The sample will comprise two groups: Non-Environmental Tobacco~     Smoke (ETS) Exposed (neither the child nor parents has ever smoked or been exposed to~     environmental tobacco smoke (ETS) in the home), and ETS-Exposed (the parent has smoked at~     least 3 cigarettes per day for at least five years in the home, with the child living in the~     home continuously). Cough sensitivity will be measured using a standard single-inhalation~     challenge, a test of the minimum concentration of capsaicin (the spicy chemical in hot~     peppers) needed to elicit cough. Sweet taste preferences will be measured using a~     forced-choice paired comparison method of liquids which differ in sucrose content. Measures~     of breath carbon monoxide will validate the smoking status of parents and their adolescent~     children. The key comparison will be between Non-ETS Exposed and ETS-Exposed children, with~     the difference between smoking and non-smoking parents as a positive control. Because smoking~     and non-smoking families may differ in ways besides tobacco exposure, the investigators will~     obtain health histories (with a focus on respiratory illness), smoking histories, measures of~     body weight, diet, and responses to personality tests (including susceptibility to~     addiction). The investigators will also obtain genomic DNA from saliva samples. Genes for~     chemosensory receptors that are part of the cough reflex pathway and genotype may account for~     aspects of cough sensitivity.~   "
165532|NCT01399047|"~     The primary objective of this trial is to establish the safety and tolerability of short-term~     (8 weeks) administration of mycophenolate mofetil in ambulatory children with JNCL. The~     secondary objective is to gather preliminary evidence of the short-term (8 week) impact of~     mycophenolate mofetil on clinically relevant features of JNCL as measured by the Unified~     Batten Disease Rating Scale (UBDRS), including motor features, seizures, behavior, cognitive~     and functional measures.~      Funding source-FDA Office of Orphan Product Development (OOPD).~   "
165533|NCT01399034|"~     The overall goal of this research is (1) to identify changes in gene expression and DNA~     methylation status in subjects who exhibit advanced chronic periodontal inflammation and (2)~     to identify microRNAs (miRNAs) and the interactive pathways associated with obesity as a~     modifier of periodontal infection pathogenesis.~   "
165534|NCT01399021|"~     There is no standard of care of management following parotidectomies. Most practitioners~     however place a drain (usually a flat Davol closed suction drain/ Hemovac in the~     investigators institutions) in the wound bed at the end of the procedure, which is usually~     removed the day following the surgery, or when the drain output reaches a subjective number~     (depending on surgeon preference). The investigators hypothesis is that there is no~     difference in hematoma/bleeding or infection rate when post parotidectomy drains are removed~     in the recovery area on the day of the surgery prior to discharge, compared to drains that~     are kept in place for at least 1 day or until drainage is less than 50 cc/24 hrs. The~     investigators would therefore like to undergo a randomized control clinical trial to assess~     the rate of significant hematoma formation and infection, the need for readmission and length~     of admission secondary to these complications when comparing 2 groups: one where drains are~     removed prior to discharge from the recovery area and the other where the patients are~     discharged with the drain and seen the next post operative day in the office. The drain~     output will then be measured and the drain taken out.~   "
165535|NCT01399008|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in~     combination with allopurinol compared to allopurinol alone when administered orally once a~     day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol~     alone.~   "
165559|NCT01398683|"~     Comparison of epidural anesthesia and general anesthesia for laparoscopic cholecystectomy,~     patients in the surgery and the effectiveness of anesthesia after surgery, the incidence of~     side effects or complications, and postoperative recovery of the body of the differences~   "
165560|NCT01398670|"~     This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's~     Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and~     Humalog® Mix in patients with Type 1 Diabetes Mellitus~   "
165536|NCT01398995|"~     People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but~     problems with metabolism and blood glucose control can make this difficult. Some people with~     T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous~     insulin infusion (CSII) therapy, in which a background or basal level of insulin is~     constantly infused under the skin by a special pump, with bolus doses of insulin given to~     accompany food. Clinical experience suggests that this may be particularly useful for~     managing diabetes for exercise, but there is limited experimental evidence to support this.~     The aim of this research , which is divided into three parts, is to investigate the~     hypothesis that the physiological response to sub-maximal (moderate) exercise of a person~     with type 1 diabetes treated with CSII, can be made to approximate more closely to the~     physiological response of a healthy individual by a prior reduction of their basal insulin~     infusion rate. Evidence from children demonstrates that reducing the basal insulin infusion~     rate to 50% of normal at the beginning of exercise can reduce rates of low blood glucose~     (hypoglycaemia) during exercise. However, reducing the insulin infusion rate will not have an~     immediate effect on levels of insulin in the body, and evidence from adults suggests that the~     level of insulin in the bloodstream at the start of exercise is an important factor in~     whether hypoglycaemia develops during exercise. This suggests that reducing the basal insulin~     infusion rate some time before exercise may be useful. The aim of this study is to compare~     the effect of a basal insulin reduction on blood glucose levels between visits when this~     reduction is made at the start of exercise, 30 minutes before, 60 minutes before and 90~     minutes before. The null hypothesis to be tested is that there is no difference between these~     conditions.~   "
165537|NCT01398982|"~     Breast reconstruction using a patient's own abdominal tissue is one of the most common~     methods for restoring mastectomy defects for breast cancer patients. Despite its increasing~     popularity and safety, the abdomen remains a major source of postoperative pain. Adequate~     pain control is important as it has been shown to reduce medical complications, in-hospital~     death, shortens hospital stay, lessen chronic pain and disability, and in turn lower~     health-care costs. The current postoperative pain relief protocol consists primarily of a~     patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause~     numerous side-effects such as sedation, headache, nausea, vomiting, breathing difficulties,~     bladder and bowel dysfunction. A promising approach to provide postoperative pain control of~     the abdominal incision is the newly developed transversus abdominis plane (TAP) peripheral~     nerve block. Although the TAP block has been found to be an effective pain-relief following~     major abdominal surgeries, its use has never been studied for breast reconstruction using~     abdominal tissue. Therefore, the investigators propose to rigorously study the efficacy of a~     TAP block in reducing postoperative abdominal pain following abdominal tissue breast~     reconstruction. This study has significant implications in improving both clinical care and~     health outcomes in patients undergoing this common method of breast reconstruction technique.~   "
165538|NCT01398969|"~     The goal of this study is to determine the outcome of patients with recurrent CDI treated~     with fresh HBT versus frozen-and-thawed HBT in a randomized controlled trial. The specific~     objectives are to evaluate the safety of both types of HBT and to compare the clinical~     response, treatment failure and relapse rate in patients treated with fresh HBT compared to~     those treated with frozen-and-thawed HBT; also to assess the functional health and well-being~     of patients in each arm using a validated tool. The metagenomics will also be conducted from~     the stool samples collected from select patients from each arm: pre and post treatment and~     the matching donors. The metagenomics data will be used to determine the bacteria which may~     have contributed to the cure of CDI.~   "
165539|NCT01398956|"~     The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are~     judged to benefit from continued treatment with Levetiracetam by the investigators and who~     are willing to continuously receive this drug.~   "
165540|NCT01398943|"~     More patients with chronic obstructive pulmonary disease (COPD) die from cardiovascular~     disease than direct pulmonary complications. Inflammation and oxidative stress,~     characteristic in COPD, are likely contributors to the reduction in nitric oxide (NO)~     bioavailability and vascular endothelial dysfunction in COPD patients; however, this has yet~     to be determined. Thus, the overall objective of this proposal is to identify the role of NO~     bioavailability in contributing to vascular endothelial dysfunction in patients with COPD and~     to provide insight into the molecular mechanisms involved. Our central hypothesis is that~     inflammation and oxidative stress, both independently, contribute to the reduction in NO~     bioavailability and vascular endothelial dysfunction in patients with COPD.~   "
165541|NCT01398930|"~     The objective of this study is to assess the efficacy of acupuncture as an adjunctive therapy~     to pharmacological treatment of chronic pain due to knee osteoarthritis, as well as for, the~     improvement of physical functioning, reduction of stiffness, and improvement in quality of~     life. This is a 3-armed single-blinded randomized sham-controlled trial, comparing~     acupuncture along with pharmacological treatment, sham acupuncture including pharmacological~     treatment, and pharmacological treatment alone. One-hundred and twenty patients with knee~     osteoarthritis were randomly allocated to 3 groups. Group I was treated with etoricoxib,~     Group II was treated with acupuncture and etoricoxib, and Group III was treated with sham~     acupuncture and etoricoxib.~   "
165542|NCT01398917|"~     Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary tract~     of unknown origin. Around 50% of patients develop during their disease course narrowing of~     the main bile duct with corresponding increase in symptoms such as itching, jaundice and~     abdominal pain. These narrowings can be treated by balloon dilatation or temporary insertion~     of a plastic endoprosthesis. However, it is not known which of these two therapeutic~     modalities is best. This study aims to compare both techniques in order to determine which is~     best in terms of postponing recurrence of the narrowing, safety and costs.~   "
165543|NCT01398904|"~     Body Dysmorphic Disorder (BDD) participants will demonstrate greater attentional biases as~     compared to healthy control (HC) participants. Greater attention bias will be associated with~     greater distress. Greater attention bias will be associated with greater symptom severity.~   "
165561|NCT01398657|"~     This is an open-label randomized clinical study comparing primary prostate cryoablation alone~     (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy~     (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.~   "
165562|NCT01398644|"~     Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in~     excessive iron overload. Phlebotomy is currently the standard therapy. More recently~     Therapeutic Erythrocytapheresis (TE) has become a new therapeutic modality, which potentially~     offers a more efficient method to remove iron overload with fewer procedures.In the proposed~     clinical trial the investigators will examine whether TE can keep the ferritin levels in~     patients requiring maintenance therapy below 50 microg/L, with minimally half the number of~     treatment procedures when compared to current standard therapy by P.~   "
165544|NCT01398891|"~     This pilot study will recruit patients admitted to the inpatient psychiatric unit at MGH for~     suicidal ideation or a suicide attempt. Inclusion criteria will be broad to increase~     enrollment rates and obtain information for patients with a wide range of diagnoses and~     illness severity. Enrolled subjects will complete randomly-selected positive psychology~     exercises daily (on weekdays) until discharge and will rate the exercises in multiple~     domains. Subjects' participation will be complete at the end of their admission or when all~     exercises have been completed, whichever comes first.~      Overall, our goal is to assess the acceptability and utility of eight possible positive~     psychology interventions related to gratitude, optimism, kindness, mindfulness, recollection,~     and forgiveness in suicidal inpatients.~      This is a single-arm study, completed with patients who have been admitted to the hospital~     for suicidal ideation or a suicide attempt. It is aimed at developing a positive psychology~     treatment aimed at suicidal patients. The study consists of serial completion of different~     positive psychology exercises, once daily, during admission, to get subjects' input on their~     feasibility and impact. This will allow us to work collaboratively to identify the specific~     exercises that best fit this population. Subjects' participation ends when they are~     discharged from the hospital. The investigators plan to enroll 30 subjects at MGH (and total)~     in this study.~   "
165545|NCT01398878|"~     The purpose of this study is to determine the impact of eliminating traditional resident work~     shifts (i.e. greater than 24 hours in length) on patient safety and resident educational~     outcomes. In addition, the investigators will explore with key stakeholders (patients and~     their families, nurses, resident physicians and attending physicians) their experiences when~     residents are undertaking shifts greater than 24 hours in length as compared to 16 hours or~     less.~   "
165546|NCT01398865|"~     The purpose of this study is to find out more about the brain's response to selective~     serotonin reuptake inhibitor (SSRIs) treatment in people with body dysmorphic disorder (BDD).~     The investigators will use positron emission tomography (PET) and Magnetic Resonance Imaging~     (MRI) scans to look at brain activity in people with BDD before and after treatment with an~     SSRI. The investigators hope that what is learned will allow prediction of whether someone~     will improve with SSRI treatment.~   "
165547|NCT01398852|"~     The purpose of this research study is to evaluate the long tern safety and effectiveness of~     cross-linking in eyes with keratoconus and ectasia.~   "
165548|NCT01398839|"~     The purpose of this research study is to test the safety, tolerability, and effectiveness of~     corneal collagen cross-linking (CXL) when used to treat ectasia.~   "
165549|NCT01398826|"~     The purpose of this study is to assess the glycemic response to cycling road races (using~     continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic~     controls. The investigators will also assess the relationship between power/work during~     cycling (using a power meter) and the subject's glucose profile.~   "
165550|NCT01398813|"~     In this survey of X-Lined Hypohidrotic Ectodermal Dysplasia (XLHED) carrier females, Edimer~     proposes to review responses to an XLHED Carrier Outlook toward Reproduction Survey in order~     to understand attitudes toward reproduction, potential treatments and genetic testing in~     order to improve the understanding of the decisions that XLHED carrier females make regarding~     their reproductive future.~   "
165551|NCT01398800|"~     Long term follow-up is needed to determine whether current Mobile Bearing revision Total Knee~     Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of mobile~     bearings in the revision TKA setting include reduction in polyethylene wear, decreasing~     fixation stresses, and protection of the constraining mechanisms. Several studies have~     reported satisfactory clinical results after revision total knee arthroplasty but no study~     with a large number has specifically addressed the clinical outcomes after revision total~     knee arthroplasty using the mobile bearing design~   "
165552|NCT01398787|"~     The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS~     contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK®~     COLORBLENDS contact lens wearers.~   "
165553|NCT01398774|"~     The investigators would like to learn more about the metabolic consequences of~     pseudohypoparathyroidism type 1a in children, adolescents and adults with this condition.~     People with pseudohypoparathyroidism 1a are at risk for development of obesity. To better~     understand the cause of overweight or obesity, investigators are measuring body composition~     and resting energy expenditure (REE), which is the amount of calories burned while completely~     at rest. The investigators also want to determine the amount of body fat.~   "
165554|NCT01398761|"~     The purpose of this grant is to fund the research necessary to fully understand the impact of~     this sign-out tool on clinician workflow, quality of sign-out, and continuity of care. This~     information will inform exactly how Partners will move ahead with tools to improve handoffs~     in care (i.e., whether the prototype will be adapted further, adopted Partners wide, or~     abandoned in favor of other solutions). The investigators hypothesize that a web-based~     handoff tool improves provider satisfaction, the quality of written sign-outs, and measures~     of continuity of care compared with current handoff tools.~   "
165555|NCT01398748|"~     Excessive free radical formation and depletion of the brain's primary antioxidant,~     glutathione, are established components of Parkinson's disease (PD) pathophysiology. While~     there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some~     preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles~     surrounding currently employed delivery methods have hindered the clinical utility of this~     therapy. Intranasal GSH, (in)GSH, is a novel method of delivery for this popular CAM therapy~     in patients with PD, and bypasses the obstacles associated with other delivery methods. It~     has been used in clinical practice since 2005. The aim of this study is to evaluate safety,~     tolerability, and preliminary absorption data of (in)GSH in volunteers with PD in a Phase I~     single ascending dose escalation study.~   "
165556|NCT01398722|"~     The investigators sought to determine whether intensive insulin therapy can improve prognosis~     of infants undergoing cardiac surgery.~   "
165557|NCT01398709|"~     The purpose of this study is to investigate the relationship between rewarming rate during~     cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.~   "
165558|NCT01398696|"~     To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in~     primary care.~   "
165563|NCT01398631|"~     Various elements of patient history are checked and entered in the admission Case Recor Form~     (CRF). Three risk scores are calculated out of these elements, combined with physical~     examination, laboratory values and ECG-findings.~      The primary aim is to assess the positive and negative predictive values for a cardiovascular~     event of the three risk scores for chest pain patients.~      Secondary aim is to assess the sensitivity and specificity of various elements in the patient~     history for an acute coronary syndrome.~   "
165564|NCT01398618|"~     Though still an endemic area, the incidence of tuberculosis (TB) in Taiwan is decreasing in~     recent years. Further reduction in TB incidence, or even elimination should rely on treatment~     for LTBI. However, which is the cost-effective screening method or what is the cost-effective~     regimen in Taiwan is still unclear.~      Therefore, the investigators designed this prospective study to follow up adult household~     contacts with LTBI for 2 years and compare the efficacy of 9-month isoniazid and 4-month~     rifampicin).~   "
165565|NCT01398605|"~     The study is designed to investigate the physical activity and its dose-response relationship~     in postmenopausal women on the cardiovascular risks and cardiac function.~   "
165566|NCT01398592|"~     This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG)~     lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a~     two weeks treatment on top of metformin.~   "
165567|NCT01398579|"~     The investigators hypothesis that~        1. clinical applicability and overall diagnostic sensitivity and specificity of pCLE for~          diagnosing gastric preneoplastic and neoplastic lesions is acceptable~        2. pCLE, as compared to white-light endoscopy (WLE), AFI and magnifying NBI has higher~          sensitivity and specificity for the diagnosing gastric pre-neoplastic and neoplastic~          lesions~   "
165568|NCT01398566|"~     Today's hospitals need innovative solutions to help patients transition from our care to~     self-management at home. The vast majority of the patients seen in Dodd Rehabilitation~     Hospital and associated clinics leave our care with persistent and life-altering challenges -~     behavioral, cognitive, emotional and/or physical. The period of time immediately following~     discharge is an under-addressed stage within the continuum of care. The investigators are~     researching solutions to help patients in this transition to self-care and believe that~     multiplayer gaming paradigms may be a promising innovation to facilitate this transition.~      The investigators believe that Dr. Jane McGonigal's SuperBetter, and positive play games like~     it, are promising novel interventions that could make a positive difference in the ability of~     our patients to successfully transition to self care after discharge from therapeutic care.~      Specifically, the investigators will evaluate feasibility of use of such a game by mild to~     moderate brain injured individuals and to record pilot data to help us plan a clinical~     effectiveness follow up study. Our goal is to finish this study with an intervention tailored~     for use within the clinical continuum of care and sufficient pilot data to prepare for a~     randomized clinical control trial of this intervention.~   "
165569|NCT01398553|"~     The Armeo Spring has proven its effectiveness in the rehabilitation of acute stroke patients.~     It neutralizes limb weight, enabling patients to use residual control in both arm and hand~     and to follow exercises guided by simulations of real-life challenges. The Armeo Spring~     incorporates wrist pronation and supination, allowing patients to enhance functional reaching~     patterns.~      Aim of the study is to compare the Armeo device with standard physiotherapy in chronic~     patients with acquired brain lesions.~      The result of the trial should show which treatment is more effective in the clinical~     practice. A significant better outcome of one arm should suggest to follow one treatment~     strategy more than the other.~   "
165570|NCT01398540|"~     The aim of this project is to investigate humoral and cellular immune responses before and~     after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years~     of age and 18-40 years old subjects.~   "
165571|NCT01398527|"~     The research question is, does a multifaceted, multidisciplinary intervention including small~     groups, chart audits and point of care tools, increase the number of people receiving optimal~     vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include the number~     of falls and fractures experienced by the residents in each LTC home and the number of~     residents receiving appropriate bisphosphonate therapy.~   "
165572|NCT01398514|"~     The purpose of the study is to learn how differences in learning under mildly-stressful~     circumstances may be changed by taking an antidepressant medication. This medication is~     called Lexapro (Escitalopram). The investigators will also examine the impact of any anxiety,~     depression, and stress related symptoms on learning processes. The investigators will also~     look at the response of these symptoms to Lexapro.~   "
165573|NCT01398501|"~     Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for~     patients with AML with the FLT3-ITD mutation and information from these studies suggests that~     sorafenib may help to control leukemia. The purpose of this study is to find the highest dose~     of sorafenib for maintenance therapy that can be safely used in participants with AML who~     have undergone allogeneic stem cell transplant.~   "
165574|NCT01398488|"~     Experimental intervention:~      Patient education after lung transplantation via Tablet computers. An electronic patient~     questionnaire via tablet computer will be collected in addition.~      Control intervention:~      Conventional Patient education by health care professionals. A paper-based patient~     questionnaire will be provided.~   "
165575|NCT01398475|"~     The purpose of this trial is to assess the effect of 3 formulations on the relative~     bioavailability of LY3009104. Participants will receive single dose of LY3009104 on 4~     separate occasions with and without food. Safety evaluation and serial pharmacokinetic (PK)~     samples will be collected during each treatment period. Approximately 5 to 7 days of washout~     period between each treatment and a follow-up visit will occur approximately 5 to 7 days~     after the last dose of study drug.~   "
165576|NCT01398462|"~     CWP232291 blocks proliferation of cancer cells via activation of caspases. Active caspase~     have been shown to target beta-catenin, the hallmark of canonical Wnt signaling, for~     degradation through caspase-directed cleavage. CWP232291 targets beta-catenin for degradation~     and thereby inhibits the expression of cell cycle and anti-apoptotic genes such as cyclin D1~     and survivin.~   "
165577|NCT01398449|"~     Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer~     after esophagectomy and with pathological stage of T1-2,N+,M0?~   "
165578|NCT01398436|"~     The aim of the study is to compare oxygen saturation of blood samples collected from the~     superior vena cava, the right atrium, and the pulmonary artery. A secondary target was to~     assess whether positioning the tip of central venous catheters in the right atrium causes~     more arrhythmias than positioning it in the superior vena cava.~      The study is carried out in patients that undergo central venous and pulmonary artery~     catheterization for surgical coronary revascularization. In the interventional group (atrium,~     A), the tip of the central venous catheter (CVC) is placed in the right atrium; in the~     control group (control, C), the tip is placed in the superior vena cava. In both groups, CVC~     position is confirmed with transesophageal echocardiography (TEE). At fixed times during~     surgery and in the following 72 hours, heparinized blood samples are collected from the~     proximal and distal CVC lumens and from the distal lumen of the pulmonary catheter (PC) and~     oxygen saturation is measured by an oximeter. Besides, mechanical and electrical~     complications potentially influenced by CVC position are registered.~        1. The primary aim of the study will be achieved by performing the following analysis on~          values from CVC proximal and distal lumens:~             1. a Bland Altman analysis between proximal and distal oxygen saturation in group A,~               in order to evaluate if the two measures are equivalent~             2. a comparison of the difference between proximal and distal oxygen saturation in~               groups A and C in order to rule out random errors~        2. In addition:~             1. differences in oxygen saturation between proximal or distal CVC and distal PC will~               be compared in order to evaluate whether distal saturation is more indicative of~               mixed venous saturation~             2. differences between proximal and distal oxygen saturation will be correlated with~               cardiac index and PCWP to investigate if low cardiac output and hypovolemia~               increase differences~        3. The secondary aim of the study will be achieved by comparing the incidence of cardiac~          arrhythmias in groups A and C~   "
165579|NCT01398423|"~     A randomized, double-blind, active control trial to determine the safety, efficacy and~     pharmacokinetics of INV-144 versus losartan potassium plus placebo in subjects with~     hypertension and Type 2 diabetes mellitus with nephropathy as evidenced by albuminuria.~   "
165580|NCT01398410|"~     The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10~     mg tablets administered once daily in participants who were confirmed to have no recurrence~     of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in~     the E3810-J081-308 (NCI01397448) [Double-Blind Phase] study. From a total of 420 participants~     who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.~   "
165581|NCT01398397|"~     This study is being done to collect information about people who have or may have~     Hypohidrotic Ectodermal Dysplasia (HED) or X-linked Hypohidrotic Ectodermal Dysplasia~     (XLHED). This study will allow Edimer Pharmaceuticals to know more about HED/XLHED so that~     hopefully the investigators can develop a drug to treat this condition. In this study Edimer~     will retrospectively review and abstract (summarize) medical records of people that have or~     may have HED/XLHED in order to further understand the natural history and disease~     characteristics.~   "
165582|NCT01398384|"~     The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on~     Myocardial Infarction Size.~   "
165583|NCT01398371|"~     Heart failure is a chronic condition in which the heart fails to function as a pump to move~     blood around the body. This sets up a complex physiologic response to compensate, which~     include activation of many hormonal mechanisms which result in fluid accumulation.~      In recent years, medications to block the hormonal response to heart failure are given as~     standard drugs, and these include ACE inhibitors, and beta blockers. Mortality is reduced~     with these medications, as well as symptoms improved.~      Medications that were traditionally used in heart failure include diuretics, which cause~     fluid loss, and digoxin, which causes the heart to pump harder. These medications were~     introduced before clinical trials as we know them now were run. Since the introduction of ACE~     inhibitors and beta blockers, it is not clear whether there is still a role for digoxin.~      In this study, we plan to withdraw digoxin from patients with stable heart failure in normal~     rhythm, taking stable doses of ACE inhibitors and beta blockers, in a closely monitored~     environment and watch for the effect of this on heart failure.~   "
165584|NCT01398358|"~     The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area~     is to reduce the prevalence of obesity among children attending Head Start in Michigan. The~     proposed intervention program is based on Social Cognitive theory and the premise that~     enhancing children's capacity for emotional and behavioral self-regulation is a key component~     of effective obesity prevention. A randomized controlled trial design is proposed to~     evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches~     to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum~     delivered to preschoolers and their parents focused on obesity-related health behaviors; and~     (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program~     designed to improve preschoolers' emotional and behavioral self-regulation. The research~     objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure,~     will lead to greater improvements in obesity-related health behaviors and adiposity indices;~     and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors~     and adiposity indices, and this effect will be mediated by improved self-regulation. The~     extension objective is to evaluate the feasibility, fidelity, and educational effectiveness~     of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators~     within Extension and Head Start. The education objective is to provide Extension and Head~     Start staff non-formal training and educational curricula which can be widely disseminated.~     The long-term goal of this project is disseminate a novel and effective approach to obesity~     prevention in preschoolers.~   "
165585|NCT01398345|"~     Background~      —Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality~     of life, and a poor prognosis because of right heart failure. The present study is the first~     prospective randomized study to evaluate the effects of exercise and respiratory training in~     patients with severe symptomatic PH.~      Methods~      —Patients with PH on stable disease-targeted medication will be randomly assigned to a~     control and a primary training group. Medication will remain unchanged during the study~     period. Primary end points will be the changes from baseline to week 15 in the distance~     walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life~     questionnaire. Changes in WHO functional class, Borg scale, and parameters of~     echocardiography and gas exchange also will be assessed.~      Prospects~      —We hope this study will indicate that respiratory and physical training are a promising~     adjunct to medical treatment in severe PH.~   "
165586|NCT01398332|"~     This is an observational Registry designed to obtain early data on the use of the GORE®~     EXCLUDER® AAA Endoprosthesis with C3 Delivery System.~   "
165587|NCT01398319|"~     The prevalence of alcohol related incidents in technical training is too high. A brief group~     alcohol intervention was designed to reduce the number of alcohol related incidents in~     Technical Training.~      Hypotheses or Research Questions:~      Can a brief group alcohol intervention, focused on responsible use of alcohol during~     technical training reduce the prevalence of alcohol related incidents?~   "
165588|NCT01398306|"~     The primary objective of this study is to analyse the concentration dopamine and serotonin in~     thrombocytes of patients with renal cell carcinoma and neuro-endocrine tumours compared to~     the concentrations of these catecholamines in healthy volunteers. The concentration dopamine~     and serotonin in thrombocytes with and without medication will also be evaluated.~   "
165589|NCT01398293|"~     This single-dose, randomized, double-blind, double-dummy, placebo-controlled,~     positive-controlled four-way crossover study will evaluate the effect of a single dose of~     danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects~     will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of~     danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D:~     placebo, with a washout period of at least 7 days between treatments.~   "
165590|NCT01398280|"~     The purpose of this study is to determine the effect of topical aminocaproic acid on the~     immune system by assessing the levels of antimicrobial peptides in the skin of patients with~     rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's~     immune system in patients with rosacea by inhibiting activation of antimicrobial peptides.~   "
165591|NCT01398267|"~     This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the~     effect of aleglitazar on renal function, the renin-angiotensin system and the~     pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with~     lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be~     randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to~     lisinopril for 4 weeks.~   "
165592|NCT01398254|"~     Primary percutaneous coronary intervention (PPCI) has become the dominant strategy for the~     treatment of ST-elevation myocardial infarction (STEMI), as studies have shown that PPCI is~     superior to fibrinolytic therapy. Recent evidence suggests that transradial access (TRA) is~     superior to transfemoral (TFA) for patients undergoing PPCI. Two large trials report a~     mortality benefit favouring TRA. The results of these two trials could significantly impact~     practice guidelines and lead to a recommendation that the approach of choice for primary PCI~     be radial rather than femoral. This would have significant implications for both PCI centers~     and interventionalists associated with a large impact on practice and education. Yet, many~     centers and interventionalists in Canada and in the USA prefer TFA and currently feel~     pressured in making the change to TRA. With that said, these trials did not include new~     pharmacotherapy and new technology that would likely have closed or eliminated the gap~     between TFA and TRA by improving the safety and efficacy of these two approaches.~     Furthermore, these trials were not powered to conclusively show a mortality benefit. The~     authors of the two large trials emphasized the need for further trials to confirm the~     benefits of TRA.~      The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing primary~     percutaneous intervention (PPCI). The primary outcome will be defined as all cause mortality~     measured at 30 days. The trial will also evaluate: 1) bleeding events and 2) the composite of~     death, reinfarction, or stroke defined as major adverse clinical events (MACE). The trial~     will include the use of antithrombotic therapy with monotherapy, with either bivalirudin or~     unfractionated heparin; the use of glycoprotein inhibitors IIb/IIIa inhibitors will be~     avoided. The study will encourage liberal use of vascular closing devices. The trial will~     also compare delays to reperfusion between the two strategies. Finally, a cost analysis is~     proposed.~      In view of recent publications, there is now a need for a large randomized trial using~     contemporary adjunct therapies to assess the safety and efficacy of the TRA vs. the TFA in~     PPCI. The proposed trial aims to conclusively show whether there is a survival benefit~     associated with the TRA approach.~   "
165593|NCT01398241|"~     This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate~     the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in~     healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally~     daily for 28 days. Follow-up will be 10 weeks after the last dose.~   "
165594|NCT01398228|"~     The burden of chronic, non-communicable disease, of which cardiovascular disease comprises a~     significant component, has increased rapidly and substantially in China over recent years.~     Over the coming decades China is predicted to experience a 69% increase in acute coronary~     disease(ACS), amounting to nearly 8 million additional events. A recent randomized trial of~     more than 15,000 patients with acute coronary syndromes, the second phase of Clinical Pathway~     for acute coronary syndromes in China (CPACS-2) study, showed that a quality improvement~     initiative could improve aspects of hospital care, including the proportion of patients~     discharged on appropriate medication. The study also identified a number of barriers to~     improved care including out of pocket costs and administration systems. However, the study~     was not able to determine the impact on clinical outcomes or the cost-effectiveness of the~     intervention. The aim of the third phase of the Clinical Pathway for acute coronary syndromes~     in China (CPACS-3) study is to determine whether a complex intervention comprising a clinical~     pathway for ACS management in combination with a number of physician and patient-oriented~     education tools can improve the quality of care and health outcomes among ACS patient~     admitted to resource-limited (provincial) hospitals. The effectiveness of the intervention~     will be evaluated using a cluster randomized trial (stepped wedge design) of ACS patients~     admitted to 104 hospitals in China. The study will incorporate two additional components (1)~     a qualitative substudy to identify the barriers and enablers to improved care and (2) a study~     comparing the cost-effectiveness of the intervention compared to usual care, from the~     perspective of the health care provider. The study will be conducted in conjunction with the~     Chinese Ministry of Health and the Chinese Society of Cardiology. The findings from CPACS3~     will be able to inform health policy-makers about the extent to which quality improvement~     initiatives can reduce the risk of death and disability among the millions of ACS patients~     admitted to hospitals in China each year.~   "
165595|NCT01398215|"~     This is a prospective chart review/data collection study of natural orifice translumenal~     endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires~     administered throughout the study. Subjects enrolled will be those intending to have a~     transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12~     months post-op.~   "
165596|NCT01398202|"~     The purpose of this study is to investigate whether a supplement of 25-hydroxyvitamin D is~     five-times more potent in raising vitamin D status (as reflected by serum 25(OH)D) compared~     to an equivalent amount of vitamin D3 in older adults. It will entail a 10 week~     supplementation study during winter months.~   "
165597|NCT01398189|"~     To examine the feasibility of molecular imaging markers in clinical psychopharmacology~   "
165598|NCT01398176|"~     The purpose of this study is to determine whether consuming mushrooms is effective in~     enhancing the function of γδ T cells.~   "
165599|NCT01398163|"~     The purpose of this study is to evaluate the effect of a commercially available fermented~     dairy product containing probiotics (4 weeks, twice a day) on the brain activity within~     specific neural circuits regulating the subjective experience of emotional valence and~     digestive well-being.~   "
165600|NCT01398150|"~     The purpose of this study is to determine whether consuming a beverage made with cranberry~     polyphenols and proanthocyanidins is effective in modifying immune function by enhancing~     immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell~     proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.~   "
165601|NCT01398137|"~     This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue~     medication usage (as measured by Rescue Medication Score as a Combined Score to inform the~     design of a phase III field study with ToleroMune Ragweed.~   "
165619|NCT01397903|"~     The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in~     patients with MDD who had an inadequate disease control with antidepressant medication.~   "
165602|NCT01398124|"~     Despite recent advances in the treatment of patients with resected NSCLC, disease recurrence~     and mortality related to lung cancer are common among patients with early stage non-small~     cell lung cancer (NSCLC). Therefore novel approaches are necessary to improve the outcome for~     early stage NSCLC. The preclinical studies conducted with vaccine based approaches provide~     the rationale to evaluate this as an adjunct to surgery for patients with early stage NSCLC.~     Administration of the vaccine before surgery will also allow for the evaluation of the tumor~     specimen for immunological responses to the vaccine.~   "
165603|NCT01398111|"~     This study will be carried out in healthy volunteers with the primary objective to evaluate~     the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised~     metered dose inhaler (pMDI).~   "
165604|NCT01398098|"~     Ultra-sound study to assess changes in intragastric volume after bowel preparation.~   "
165605|NCT01398085|"~     IoN is a phase II/ III trial that will look to ascertain whether or not radio-iodine ablation~     is necessary for low risk differentiated thyroid cancer patients.~   "
165606|NCT01398072|"~     Chronic Obstructive Pulmonary Disease (COPD) is the cause of considerable deaths, and~     exacerbations (flare up of symptoms) are a major cause of hospital admission in the UK.~     Bacterial infections play an important role in the development of COPD, however, there is~     little information available about the use of long term antibiotics in the treatment of this~     disease. Therefore the purpose of this study is to identify the best antibiotic regime for~     treating patients with COPD who have persistent bacterial infection in their lung. We will~     test a variety of approaches including both older and newer regimes prescribed either on a~     daily basis at a lower dose or in pulsed courses (for example, every other day or five days~     every month). The three antibiotics tested in this study are: moxifloxacin, azithromycin and~     doxycycline. This is a 13 weeks study conducted at the Royal Free Hospital, London. It is~     expected that approximately 200 patients will be selected for this study. The information we~     get from this study may help us to treat future patients with COPD better.~   "
165607|NCT01398059|"~     The purpose of this study is to determine whether acute bouts of sedentary behaviour (with or~     without breaks and/or structured physical activity) result in measurable changes in metabolic~     health in children and youth.~   "
165608|NCT01398046|"~     The goal of this study is to evaluate the ability of a natural supplement (betaine~     hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The investigators~     predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers~     pre-treated with proton-pump inhibitors (PPIs).~   "
165609|NCT01398033|"~     There is both a poor life expectancy and a poor prognosis of limb salvage in those patience~     with stenoses or occlusions of the lower limb. To date only a small number of these patients~     could be helped through medication or surgery. The indications for stent placement are poor~     primary results following percutaneous transluminal angioplasty or evidence of a~     flow-limiting dissection. The primary success rate after a stent placement is between 80% and~     90%. One so far inconsistent discussed problem is the occurrence of in-stent restenosis which~     is expected in 20% to 78% of treated lesions, depending on the stent used. Using only~     percutaneous transluminal angioplasty for treatment of an in-stent restenosis, restenosis~     reoccurs in 70% to 80% of cases.~      The aim of this study is to analyse the primary success and the long term results of~     angioplasty using the drug-coated balloon (paclitaxel) compared to an non-coated balloon in~     the treatment of in-stent restenosis of lower limb arteries.~   "
165610|NCT01398020|"~     The investigators wish to compare the efficacy and patient tolerability of a preparation~     consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte.~     The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher~     efficacy and tolerability.~   "
165611|NCT01398007|"~     Dental fear and anxiety in children constitue a crucial challenge to dental care delivery as~     well as future behavior related to dental problems in children. A common cause of such~     anxiety and fear is the procedural intervention that uses needles and syringes since a visual~     impact due to the needle acts as a deterrent to the child's cooperation during dental~     procedures. We therefore improvised the syringe such that it will camouflage the needle. We~     hypothesized that the use of this needle will alleviate the child's anxiety and therefore~     will demonstrate improved outcomes related to pain, fear and anxiety. This study is a group~     randomized trial to test the efficacy of the camouflage syringe as compared to the~     conventional syringe in children.~   "
165612|NCT01397994|"~     This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener,~     nicorandil in patients of chronic stable angina.~   "
165613|NCT01397981|"~     The purpose of this study is to determine how well people can be trained to produce new and~     different movements through the use of haptic feedback. One particular application is~     retraining individuals to walk differently in order to reduce knee joint loads to prevent or~     treat knee osteoarthritis as an alternative to surgical treatments.~   "
165614|NCT01397968|"~     This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared~     to baseline in subjects with partial onset seizures not fully controlled despite their~     treatment with 1 to 3 concomitant anti-epileptic drugs.~      Also to evaluate the safety and tolerability of YKP3089.~   "
165615|NCT01397955|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Julina for postmenopausal~     osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in~     clinical practice. A total 100 patients will be recruited and followed 3 years since starting~     Julina administration.~   "
165616|NCT01397942|"~     To investigate if a high dietary intake of bitter and strong tasting vegetables have positive~     health effects (insulin sensitivity, glucose tolerance, central obesity, fasting and~     postprandial lipid profile, blood pressure, vitamin D status and inflammatory markers,~     biomarkers of oxidative stress) on subjects with T2D. Also to look at a high dietary intake~     of mild and sweet modern vegetables or a normal western diet.~   "
165617|NCT01397929|"~     First in human, open-label, sequential dose escalation and expansion study of intravenous~     BAL101553 in adult patients with advanced solid tumors.~   "
165618|NCT01397916|"~     The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia~     (CLL) is studied.~   "
165621|NCT01397877|"~     This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment of~     initial or recurrent metastatic endometrial cancer after first line radio chemotherapy.~      Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending~     on the group of patients. The primary endpoint is the non-progression rate at 3 months (12~     weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the~     non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive~     disease (high grade tumor = stratum 2).~      Disease progression is defined by the RECIST 1.1 criteria~   "
165622|NCT01397864|"~     This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients~     treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form~     (Ruconest), to observe adverse events and insufficient efficacy, and to assess the~     immunological profile following single and repeated treatment with Ruconest.~   "
165623|NCT01397851|"~     Preliminary evidence from ongoing research provides strong indications that protecting~     farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan Africa.~     The study team invests in experimental research to investigate this conjecture in more~     detail.~   "
165624|NCT01397838|"~     Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone~     degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to~     evaluate the safety of Pro-bone.~   "
165625|NCT01397825|"~     This is a single-arm, open-label, multicenter, dose escalation, phase 1-2 study of alisertib~     (MLN8237) administered in patients with relapsed or refractory diffuse large B-cell lymphoma~     (DLBCL)/transformed follicular lymphoma (TFL) treated with rituximab and vincristine. The~     study has three parts as follows:~      Phase 1, Part 1: Safety lead-in cohort to evaluate alisertib (MLN8237) and rituximab.~      Phase 1, Part 2: Dose escalation cohort to evaluate alisertib (MLN8237) + Rituximab +~     Vincristine and determine Phase 2 dose. Patients with other types of B-cell lymphoma~     (including mantle cell or Burkitt's lymphoma may enroll in Parts 1 and 2.~      Phase 2: Alisertib (MLN8237) + Rituximab + Vincristine in patients with relapsed or~     refractory DLBCL or TFL at recommended Phase 2 dose.~      Note that in 2013 Sponsor decision was taken to not initiate the phase 2 portion of the~     trial, which would have investigated the triplet at the recommended phase 2 dose identified~     in part 2. This decision was based on reprioritization within the company and not on any~     clinical or safety outcomes observed.~   "
165626|NCT01397812|"~     The purpose of this study is to demonstrate and validate a breath test for detection of~     biomarkers of heart transplant rejection (Grade 2R heart transplant).~   "
165627|NCT01397799|"~     This Phase 1b study will determine the maximum tolerated dose of KX2-391 given as a~     once-daily dose, in elderly patients with acute myelogenous leukemia.~   "
165628|NCT01397786|"~     The purpose of this study is to assess the long-term safety, tolerability and efficacy of~     oral OPC-34712 as monotherapy in adults with schizophrenia.~   "
165629|NCT01397773|"~     The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal~     dialysis and those in the pre-dialysis period; and to compare these groups with the control~     group; so as to investigate the eligibility of it as a reliable marker of inflammation;~     relationship with other inflammatory markers and carotis intima media thickness.~   "
165630|NCT01397760|"~     The purpose of this study is do describe the experience in the use of omalizumabe, in a real~     life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient~     clinics, and its efficacy and safety. The efficacy of omalizumab in the population observed~     will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations,~     emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma~     medication).~   "
165631|NCT01397747|"~     The primary objective is to determine the sensitivity and specificity of the Exact Colorectal~     Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method.~     Lesions will be confirmed as malignant by histopathologic examination.~      The secondary objective is to compare the performance of the Exact CRC screening test to a~     commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions~     will be confirmed as malignant or precancerous by colonoscopy and histopathologic~     examination.~   "
165632|NCT01397734|"~     In this research study, the investigators are looking to see whether the combination of~     arsenic trioxide with a tyrosine kinase inhibitor is safe, and what effects it has on chronic~     myelogenous leukemia.~   "
165633|NCT01397721|"~     The Multi-Ethnic Study of Atherosclerosis (MESA) - Chronic Obstructive Pulmonary Disease~     (COPD) Study aims to characterize the pulmonary vascular changes and their biology in early~     COPD using imaging, gene expression profiling and peripheral cellular measures.~   "
165634|NCT01397708|"~     This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in~     combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a~     protein that may improve the body's natural response to disease by enhancing the ability of~     the immune system to kill tumor cells and may interfere with blood flow to the tumor.~      The main purpose of this study is to evaluate the safety and tolerability of tumor injections~     of INXN-2001 given in combination with different doses of INXN-1001.~   "
165635|NCT01397695|"~     Terence M. Davidson, MD is conducting a research study to find out more about the topical~     application of Avastin (proper chemical name is bevacizumab) in the treatment of epistaxis~     (nose bleeding) in patients with Hereditary Hemorrhagic Telangiectasia (HHT).~   "
165636|NCT01397682|"~     The goal of this research study is to collect clinical data, comprehensive geriatric~     assessment, risk factors, biological data and blood samples from inpatients aged 65 and older~     at the INRCA research hospitals (Italy). All data will be stored in a research bank and used~     to better clarify the mechanisms underlying the condition of frailty in aged patients. The~     database will be created on the INRCA server platform by establishing a safe HTTPS protocol.~   "
165646|NCT01397552|"~     Comparison of Dexamethasone versus Depo Medrol when used in lumbar epidural injections will~     be conducted on subjects that have not had previous injections or have not had an injection~     in the last 12 months. Subjects must be receiving one level injection and not had prior~     surgery at that level.~   "
167329|NCT01375478|"~     This open-label, retrospective, observational study will evaluate the compliance to~     RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid~     arthritis. Six months data will be collected from patients records.~   "
165637|NCT01397669|"~     To compare the immunophenotyping and immunochemistry in the gut mucosa of HIV negative and~     non-acute HIV-infected adults~        1. To compare the immunophenotyping of the gut mucosa to that of the peripheral blood in~          HIV negative and in non-acute HIV-infected subjects~        2. To compare the immunophenotyping of the peripheral blood in HIV negative and non-acute~          HIV-infected adults to the findings from acutely HIV-infected subjects in the~          WRAIR#1494/RV254/ SEARCH 010 study~        3. To compare immunologic markers in the genital compartment compared to the peripheral~          blood in HIV negative and non-acute HIV-infected adults to the findings from acutely~          HIV-infected subjects in the WRAIR#1494/RV254/ SEARCH 010 study~        4. Archive samples for immunologic and virologic testing~   "
165638|NCT01397656|"~     STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR~     quality after 5 minutes of continuous chest compressions versus the 2005 30:2 chest~     compression to ventilation Resuscitation Guidelines, in a population aged 55 or greater.~      More specifically, the investigators will compare each CPR ratio with regard to:~        1. The achieved frequency and depth of chest compressions, and~        2. Participant rating of their perceived level of exertion.~      STUDY HYPOTHESIS~      In a population aged 55 or greater, the new CPR recommendations will lead to:~        1. less frequent and shallower chest compressions over the 5-minute study period; and~        2. higher rating of perceived level of exertion when compared to the 2005 30:2 CPR ratio.~   "
165639|NCT01397643|"~     Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon~     fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence~     regarding the optimal treatment and outcome of these fractures within the elderly population~     with one case series in the literature describing 13 patients. Our trial includes all~     patients equal to or over the age of 75yrs presenting to the Edinburgh and Fife Orthopaedic~     Trauma Units with an isolated olecranon fracture. Patients who consent to enrol in the trial~     will be randomised to operative fixation using one of two treatment methods. Patients in the~     nonoperative group will be place in a sling for two weeks and then allowed to mobilise under~     supervised physiotherapy as per normal protocol. For those patients in the operative group,~     tension band wire of plate fixation will be employed depending on the choice of their~     supervising consultant. Patients will be evaluated over a one year period following their~     treatment.~   "
165640|NCT01397630|"~     The ultimate objective is to test the hypothesis that an 'accelerated titration' protocol for~     labour augmentation with oxytocin reduces the risk of caesarean births relative to a 'gradual~     titration' protocol.~      The aims of this pilot feasibility are:~        1. To assess the feasibility of a large multi-centre randomized control trial comparing the~          two above oxytocin protocols (accelerated titration versus gradual titration for~          correction of dystocia).~        2. More specifically, to identify potential challenges in the study implementation,~          particularly with respect to patient recruitment, randomization, blinding, and~          compliance/adherence to the labour management guidelines and study protocols.~        3. To obtain preliminary data on the acceptability of the accelerated oxytocin titration~          protocol among obstetrical providers and participants.~   "
165641|NCT01397617|"~     The purpose of this study is to determine the survival rate, marginal bone resorption, soft~     tissue health and maintenance of the NobelActive Internal and External implants and to make~     comparisons with the NobelReplace Tapered Groovy implant placed in healed sites.~   "
165642|NCT01397604|"~     The advent of vaccines contributed to major improvements in human morbidity and mortality due~     to infectious diseases such as polio, small pox, measles and diphtheria. However infectious~     diseases like HIV, malaria and tuberculosis continue to be major causes of death worldwide~     and conventional vaccine strategies have not been successful. The fundamental problem is that~     current protein based vaccines do not elicit the necessary T-cell immunity. Experimentally,~     adjuvants can be given in conjunction with a vaccine to activate and mature the dendritic~     cell (DC), which can then direct an immune response to enhance T-cell immunity. One family of~     potential adjuvants functions through the activation of Toll-like receptors (TLR) on the DC.~     Major gaps exist in our understanding of adjuvant effects in humans. We hypothesize that a~     synthetic adjuvant directed to activate TLR4 (GLA) will safely stimulate the innate immune~     system when administered subcutaneously (SC) or intramuscularly (IM). Importantly, in~     contrast to other adjuvant trials in which adjuvant is combined with an antigen or vaccine,~     GLA will be tested in isolation. This is because we anticipate the future administration of~     GLA with our dendritic cell targeted HIV vaccine. A DC-targeted vaccine cannot be given~     without an immune stimulating adjuvant due to potential risk of inducing immune tolerance.~     Therefore, in order to understand the specific contributions of GLA versus the DC-targeted~     vaccine, we need to understand the GLA effects in isolation. The safety and tolerability of 2~     different formulations of GLA (GLA-SE vs. GLA-AF) administered by 3 different routes (SC, ID,~     IM) will be the major focus of this trial. The second focus will be characterizing the innate~     immune response by assessing systemic cytokine and chemokine levels and determining global~     gene regulation following GLA stimulation. The third focus will be on the cellular effects of~     GLA, specifically on blood monocytes and dendritic cells. Monocytes may represent a large~     pool of inducible potent DC (monocyte-derived DC), however these cells have not been well~     characterized in humans. We will investigate the effects of GLA stimulation on the peripheral~     blood monocyte subsets that might give rise to monocyte-derived DC.~   "
165643|NCT01397591|"~     This phase II trial studies how well giving ofatumumab together with bortezomib works in~     treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma~     (FL), or mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or carry cancer-killing substances to them.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving ofatumumab together with bortezomib may help kill more cancer cells~   "
165644|NCT01397578|"~     This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to~     evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET~     imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.~   "
165645|NCT01397565|"~     Laparoscopic cholecystectomy is one of the most commonly performed operations in general~     surgery and is considered the standard of care for cholecystectomy for benign biliary~     disease. The laparoscopic approach to cholecystectomy, when compared to open surgery, is~     associated with less postoperative pain, quicker recovery time and an improved cosmetic~     result.~      Most commonly, laparoscopic cholecystectomy is performed using a 10-12mm port in the~     umbilicus with 3 additional ports consisting of either three 5mm ports, or a combination of~     two 5mm ports and one 10mm port. A new technique called minilaparoscopic (also referred to as~     needlescopic) surgery has recently emerged. Minilaparoscopic surgery replaces 5mm trocars~     with smaller 3mm trocars. Surgery using these smaller trocars is hypothesized to further~     reduce postoperative pain and recovery time as well as improve cosmetic results following~     laparoscopic surgery. Our goal is to compare these outcomes in a randomized trial comparing~     conventional to minilaparoscopic cholecystectomy.~   "
165647|NCT01397539|"~     The primary objective of the study is to evaluate the safety and tolerability of a range of~     BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to~     moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study~     population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of~     BIIB037 after single-dose administration.~   "
165648|NCT01397526|"~     Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and~     hypothermia in children. The oedema formation is due to increased fluid transport from blood~     to tissue. This transcapillary fluid transport is dependent on differences in interstitial~     and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate changes~     in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary~     bypass in children. The study hypothesis is that oedema developed during cardiopulmonary~     bypass and hypothermia is caused by increased micro vascular protein leakage and reduced~     colloid osmotic pressure gradient through the capillary membrane.~   "
165649|NCT01397513|"~     The fibrin network is an important component of an arterial thrombus and its structure~     influences the degradation of the formed clot. A tighter and less permeable fibrin network,~     which is less susceptible to fibrinolysis, is formed in patients with manifest cardiovascular~     disease (CVD) or conditions associated with increased risk of atherothrombotic complications.~     In a previous study we have shown reduced fibrin network permeability in patients with type 1~     diabetes, which may contribute to their increased risk of CVD. Low dose aspirin treatment is~     standard in management of CVD; however, the effect seems reduced in patients with diabetes.~     Our previous studies have shown that aspirin treatment alters the fibrin network in~     non-diabetic individuals and increases the fibrin network permeability. The effect of aspirin~     on fibrin network formation in patients with diabetes is unclear.~      We hypothesized that patients with type 1 diabetes might need higher doses of aspirin than~     the recommended low dose (75mg) treatment to gain effects on fibrin network permeability, and~     that the effects of aspirin treatment on fibrin network in these patients are influenced by~     the glycemic control.~   "
165650|NCT01397500|"~     Growth hormone and gonadotropin deficiency after brain injury (traumatic brain injury,~     ischemic stroke, subarachnoidal hemorrhage): the effects of hormone replacement on cognition,~     quality of life and body composition Randomized, controlled, 3 arm (group 2: double-blind;~     groups 1 and 3: open), multi-center, pilot study (Phase II)~   "
165651|NCT01397487|"~     The aim of this study to evaluate the effect of embryo biopsy on blastocyst development and~     implantation rate.~   "
165652|NCT01397474|"~     -  Impaired peripheral perfusion is related to worse outcome in critically ill patients.~          Although this is known, these parameters have never been used as target for hemodynamic~          therapy.~        -  We hypothesize that targeting of fluid administration on parameters of peripheral~          perfusion might prevent excessive fluid administration, leading to less formation of~          tissue edema, less respiratory dysfunction and shorter duration of mechanical~          ventilation in critically ill patients.~   "
165653|NCT01397461|"~     This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for~     ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo~     comparison), superiority clinical study comparing ozenoxacin cream versus placebo and~     retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or~     bullous impetigo.~   "
165654|NCT01397448|"~     The primary objective of this study to evaluate the effect of preventing recurrence of~     gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or~     Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose~     aspirin and thereby examine the superiority of E3810 over Teprenone.~   "
165655|NCT01397435|"~     The bone status in Gaucher disease is very difficult to monitor precisely in children. This~     is a major problem because lack of optimal treatment, especially enzyme replacement, may~     cause irreversible severe bone damage that will impact an affected person's life. Currently,~     there are qualitative (subjective) methods, such as Magnetic resonance Imaging (MRI), to~     gauge the response to treatment. A quantitative (objective) measurement of Gaucher cell~     presence and activity in bone marrow could help with more precise and accurate monitoring of~     bone marrow disease in patients both treated and not (yet) being treated with enzyme~     replacement. The investigators will evaluate the efficacy of Magnetic Resonance Spectroscopy~     (MRS) as a quantitative assessment of bone marrow involvement in Children with Gaucher, and~     examine how this result correlates with semiquantitative MRI scales and overall disease~     severity.~   "
165656|NCT01397422|"~     This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group~     study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral~     capsules, an extended release formulation of amantadine, dosed once daily for the treatment~     of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel~     pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma~     concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms~     of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may~     reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and~     iii) a reduced initial rate of rise in plasma concentration, which is expected to improve~     overall tolerability of amantadine.~   "
165657|NCT01397409|"~     This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of~     the safety of AGN-150998 administered as a single intravitreal injection to patients with~     advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are~     randomized, double-masked, comparisons of the safety and treatment effects on retinal edema~     and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive~     patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a~     fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest~     tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on~     retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of~     AGN-150998.~   "
165658|NCT01397396|"~     The additional effect of inspiratory muscle training as an adjunct to a general exercise~     training program in patients with COPD with inspiratory muscle weakness will be studied. The~     main hypothesis is that inspiratory muscle training combined with an exercise training~     program improves functional exercise capacity more than an exercise training program without~     the addition of an inspiratory muscle training program.~   "
165659|NCT01397383|"~     The investigators would like to evaluate the effect of serum 25-hydroxy vitamin D level on~     post-operative short-term functional outcomes after total hip arthroplasty (THA).~      Hypothesis: Patients with low serum vitamin D level will have less within-patient improvement~     in pre- to 6 week, 1 year, 2 year and 5 year post THA WOMAC scores, SF-36 scores, and~     performance-based tests(get up and go test and 2 minute walking test) compared to patients~     who do not have a low vitamin D levels.~      Also, Patients with low serum vitamin D level will have a higher rate of postoperative thigh~     pain or periprosthetic fracture.~   "
165660|NCT01397370|"~     The purpose of the study is to evaluate the safety and tolerability of multiple ascending~     oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and~     to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple~     oral administrations.~   "
165661|NCT01397357|"~     The purpose of this study is to evaluate CARDIAC MAGNETIC RESONANCE UTILITIES IN THE ISCHEMIC~     HEART DISEASE as topographical correlation between ischemic territory injury and coronary~     angiography.~   "
165662|NCT01397344|"~     Doctors' attire has known to impact patients' trust and confidence for better clinical~     practice. However, few survey research regarding this topic has been conducted in traditional~     asian medicine field. The aim of our study is to determine whether traditional medicine~     doctor's attire impacts on patients' confidence and trust.~      Participants will be given randomly one set of photographs from the 2 kind of photographs,~     i.e., photographs of a male or female doctor, each set dressed in 4 different styles.~      After this, they will be asked to report their preferences for the 4 styles of dress~     according to given questions and they will answer the degree of their feeling on the~     importance of Korean Medicine doctor's appearance.~   "
165663|NCT01397331|"~     The aim of the study is to delineate and compare the changes in coupled mechanical properties~     of left ventricle and arterial vascular bed caused by two popular anesthetic protocols~     commonly used in cardiac surgery (intravenous, based on the infusion of propofol, versus~     inhalational, based on isoflurane) on different stages of the surgery.~   "
165664|NCT01397318|"~     Many pregnant women experience stress, fatigue, and poor sleep quality that may influence~     infant outcomes such as prematurity and low birthweight through immunologic pathway of~     biomarkers (serum cytokines and c-reactive protein). In contrast, TaiChi exercise, one kind~     of physical activity, can increase pulmonary and immune functions and reduce stress may~     therefore prevent pregnancy complications and further prevent adverse pregnancy outcomes;~     however, its effects has not been explored in studies. Therefore, this study aims to~     investigate relationships between prenatal stress, fatigue, sleep quality, biomarkers, and~     infant outcomes; modified a TaiChi exercise program suitable for pregnant women; and test the~     effects of the exercise on reducing stress and fatigue, promote sleep quality, modulate~     biomarkers, and prevent adverse infant outcomes. Infant outcomes in the study will be~     measured with gestational age and birthweight. The study is a three-stage longitudinal~     interventional design.~   "
165665|NCT01397305|"~     The purpose of this study is to determine whether an optimal dose of [6R]~     5,10-methylenetetrahydrofolate (Modufolin) in combination with pemetrexed are effective in~     pre-operative treatment of patients with resectable rectal cancer.~   "
165666|NCT01397292|"~     The purpose of this research study is to examine the safety, tolerability, and effectiveness~     of currently available pulmonary procedures when used to diagnose or treat different~     diseases.~      This study will collect information that may influence the outcome of the procedure and~     identify factors that may affect the procedures yield or safety. The information will be~     entered into a registry or data storage.~   "
165667|NCT01397279|"~     Type 2 diabetes is associated with hepatic insulin resistance. One consequence of insulin~     resistance of the liver is an altered hepatic glucose metabolism. This study investigates~     whether the whole body (M-value) and hepatic insulin sensitivity obtained by hyperinsulinemic~     euglycemic clamp is influenced by a preceding intravenous glucose tolerance test (Botnia~     Clamp) in subjects with type 2 diabetes.~   "
165668|NCT01397266|"~     In a randomized, double-blind controlled trial the investigators will evaluate the efficacy~     of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative~     analysis - such behavior and possible behavioral consequences related.~   "
165669|NCT01397253|"~     Communication between physicians caring for a patient in the hospital and that patient's~     primary care provider is less than optimal, and can lead to diminished health care quality~     and safety. This project will lead to better communication between physicians and could~     decrease medication errors that tend to occur as the patient goes from hospital to home.~   "
165670|NCT01397240|"~     The purpose of this study is to research the safety and efficacy of Albis® for the prevention~     of aspirin-induced gastrointestinal ulcers in patients taking low-dose aspirin.~   "
165671|NCT01397227|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of two~     dose levels (1x10^10 and 5x10^10 virus particles (vp)) of the adenovirus serotype (Ad)~     Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate vaccine, followed by an evaluation of the~     protective efficacy of the higher dose level in an experimental malaria challenge.~      The study will be in 3 phases:~        1. a dose escalation / vaccination phase in which both dose levels will be tested~        2. a malaria challenge phase in which only subjects receiving the Ad35.CS.01/Ad26.CS.01~          5x10^10 vp dose level, together with six infectivity control subjects, will be exposed~          to experimental challenge with Plasmodium falciparum~        3. a long term follow up phase in which all subjects who received active vaccine from both~          dose levels and/or malaria challenge will be included~   "
165672|NCT01397214|"~     Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety~     compared to Megace OS.~      Phase I study divided into 3 parts written as belows.~      Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace~     OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers~   "
165673|NCT01397201|"~     The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses~     twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI)~     at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in asthmatic~     patients aged 12 to 65 years inadequately controlled on low dose Inhaled corticosteroid (ICS)~     as demonstrated by a decrease in forced expiratory volume in one second (FEV1 (range 10-25%)~     and an asthma control questionnaire (ACQ-6) greater or equal 1.5 at time of randomisation~   "
165674|NCT01397188|"~     PiCCO has become a widely used haemodynamic monitoring device in the management of shock~     patients in ICU patients nowadays. But the effects on outcome of use of Picco, such as~     hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical~     ventilation-free days and change of lactate and BNP in shock patients has not been~     determined. Patients will be randomly assigned to a Picco group or the control group,~     hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical~     ventilation-free days and change of lactate and BNP will be observed. The conclusion will~     supply evidence for the clinical effectiveness of Picco in shock patients.~   "
165675|NCT01397175|"~     The primary objective of this study is to compare the rate of device-oriented composite~     consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget~     vessel, and clinically indicated target lesion revascularization among the patients treated~     with EES, ZES-R, or BES at 24-month clinical follow-up post-index procedure. Trial end points~     are summarized in Table I. The hypothesis is that BES is equivalent to EES or BES is~     equivalent to ZES-R at the primary end point.~   "
165676|NCT01397162|"~     The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses~     twice daily (b.i.d.) and fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA~     MDI) at a dose of 88 mcg b.i.d and placebo b.i.d. over an 8-week treatment period in~     asthmatic patients aged 12 to 65 years inadequately controlled on short-acting-beta-agonist~     (SABA) prn therapy only as demonstrated by a decrease in forced expiratory volume in one~     second (FEV1) range10 to 25% and an asthma control questionnaire (ACQ-6) equal or greater~     than 1.5 at time of randomization~   "
165677|NCT01397149|"~     The aim of this study is to find the appropriate dose of eltrombopag in thrombocytopenic CLL~     patients, that shortens the duration of the thrombocytopenia and achieves platelet count of ≥~     100/nl prior to the start of chemotherapy containing alkylating agents and/or Purine~     Analogues.~   "
165678|NCT01397136|"~     In the present project we propose to deeply characterize nuclear and/or mitochondrial DNA in~     embryo culture medium, in order to investigate whether both cell-free nucleic acid types may~     provide additional, reliable, predictive parameters for embryo viability and implantation~     potential.~   "
165679|NCT01397123|"~     The purpose of this study is to assess the effects of a six months nutrition intervention,~     delivered and taught by classroom teachers with in-service nutrition training, on the~     prevention of overweight and obesity among children in grades 1 to 4.~      In this randomized controlled trial, 464 children from seven elementary schools were~     allocated to a six months nutrition educational intervention by their own teachers or to~     standard care. Intervened teachers had 12 sessions of three hours each with the researchers~     throughout six months, according to the following topics: nutrition and healthy eating~     (sessions 1 to 4); the importance of drinking water (session 5); strategies to encourage~     fruits and vegetables consumption and to decrease high energy-density foods intake (sessions~     6 to 8); strategies to increase physical activity (sessions 9 and 10); and healthy cooking~     activities (sessions 11 and 12). After each session, teachers were encouraged to develop~     activities in class that focused on the learned topics. Sociodemographic, anthropometric,~     dietary, and physical activity assessments were performed at baseline and the end of~     intervention.~      We expect that fewer intervened children become overweight and the consumption of fruit and~     vegetables will be higher. In addition, we expect a less consumption of low-nutrition high~     dense foods.~      We also expect to provide further support to decrease overweight epidemic, involving~     classroom teachers in a training intervention and making them dedicated interventionists.~   "
165680|NCT01397110|"~     The purpose of this study is to investigate the influence of physical training on exercise~     capacity, quality of life, functional class, oxygen consumption and right ventricular~     function in patients with severe associated pulmonary arterial hypertension (APAH) as part of~     a congenital heart defect with / without Eisenmenger's Syndrome~   "
165681|NCT01397097|"~     The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years~     inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant~     over a period of 12 months.~      Secondary objectives are to observe the bleeding patterns, adverse event profiles and the~     occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions~     and implant site complications will be collected.~   "
165682|NCT01397084|"~     Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving~     rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant~     improvement of heartburn after 8-week treatment.~   "
165683|NCT01397071|"~     Avocados are naturally rich in antioxidants, or beneficial compounds, that can help prevent~     many diseases, like atherosclerosis (hardening of the arteries). When foods that are high in~     fats are eaten, certain harmful compounds can be absorbed, which can lead to atherosclerosis.~     One harmful compound is called malondialdehyde, or MDA. This compound can be measured in the~     blood and the urine after a person eats a high fat meal. Antioxidants found in herbs and~     spices may lower the absorption of MDA, which could help prevent the development of~     atherosclerosis.~      This study will determine whether the beneficial compounds of avocado can reduce absorption~     of MDA. This will be tested by asking healthy males to eat a high fat ground beef patty with~     or without avocado and then measuring the amount of MDA in their blood and urine samples.~     Blood flow will also be measured. Healthy men have been chosen for this study because eating~     high fat hamburger patties can easily mimic in them the condition that causes~     atherosclerosis. Avocadoes are rich in antioxidiants, which have been shown in previous~     studies to reduce the absorption of harmful compounds, like MDA, that are formed during~     cooking. The results from this study may help to explain how high fat foods can be harmful to~     the body and how beneficial antioxidants from herbs and spices can protect the body.~      This will be determined from blood and urine samples after the subjects are given two~     different meals: a) a plain cooked ground beef patty, and b) or avocado with a cooked ground~     beef patty.~   "
165694|NCT01396928|"~     The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is~     able to improve functional results and quality of life after coloanal anastomosis.~   "
165695|NCT01396915|"~     This study is designed to assess the effect of a diet-controlled nutrition program utilizing~     an egg-based higher protein diet on muscle composition and size, and indices of metabolic~     health and markers of systemic inflammation in older men and women who are slightly~     overweight.~   "
165684|NCT01397058|"~     Background. Human herpes viruses establish lifelong latency after primary infection and may~     reactivate in immunosuppressed patients causing significant morbidity and mortality. In~     immunocompetent patients, although reactivation may occur disease development is deterred by~     the competent host immune response. Recent studies indicate that approximately one third of~     CMV seropositive immunocompetent ICU patients present with CMV reactivation associated with~     poor outcome, potentially secondary to the stress incurred. CMV reactivation among~     immunocompetent critically ill children has not been assessed.~      Study Hypothesis: Identifiable risk factors associated with CMV reactivation exist and may be~     used for future assessment of antiviral prophylaxis administration.~      Aim: Primary aim is to identify risk factors associated with CMV reactivation and poor~     outcome in immunocompetent children and adults under severe stress. Whether CMV reactivation~     occurs in critically ill children and its clinical implications remains to be determined.~     Secondary aim is to study the role of cellular signaling pathways of inflammation and~     specific adaptive immunity during this process.~      Work packages: A multicenter observational prospective study will be conducted among CMV~     seropositive pediatric and adult ICU patients. Patient clinical progress, laboratory~     findings, management, and complications will be recorded during the 28 days following ICU~     admission. Salivary free cortisol levels, plasma catecholamines, and serum cytokines levels~     will be measured to assess stress. CMV reactivation will be evaluated weekly by detecting~     CMV-DNA in peripheral blood and bronchial wash samples with real-time PCR. In a patient~     subsample, the nuclear factor κB and intracellular GC receptor will be measured in peripheral~     blood monocytes to study cellular signaling pathways of inflammation. The adaptive immune~     response to CMV infection following in vitro viral polypeptide stimulation will be~     prospectively examined in a subset of patients.~      Expected Results: The study will provide original data on critically ill children. Further~     knowledge regarding risk factors associated with CMV reactivation and poor outcome will be~     accumulated. Novel information regarding the role of cellular inflammation and specific~     adaptive immune responses during CMV reactivation will be gathered.~   "
165685|NCT01397045|"~     Aim of this prospective randomized study is to assess the safety and efficacy of~     video-assisted lung segmentectomy (Group B) comparing with mini muscle-sparing thoracotomy~     (group A) during diagnostic process for pulmonary nodules.~   "
165686|NCT01397032|"~     Children with social anxiety will be randomly assigned to either Attention Bias Modification~     Treatment (ABMT) designed to direct attention away from threat or a placebo control condition~     not designed to change attention patterns. Outcome measures will be depression and social~     anxiety symptoms as measured by gold standard questionnaires as well as diagnosis of social~     phobia disorder and symptom counts derived from structured clinical interviews with children~     and their parents.~      We expect to see significant reduction in social anxiety symptoms in the Attention Bias~     Modification Treatment (ABMT) group relative to the placebo control group.~   "
165687|NCT01397019|"~     Treating patients with initial local non-resectable pancreatic cancer with a combination of~     oxaliplatin, irinotecan & 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in~     potentially resectable patients, will result in a high rate of tumor shrinkage allowing~     subsequent resection in patients with initial borderline resectable tumors and improved~     overall survival for all patients.~   "
165688|NCT01397006|"~     The purpose of the study is to evaluate whether pregabalin is effective in treating subjects~     who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for~     treatment of fibromyalgia. the purpose of the study is to see if subjects identified through~     their primary care physicians who have fibromyalgia and have had symptoms for less than one~     year respond to pregabalin and to identify characteristics of that response.~   "
165689|NCT01396993|"~     Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast~     cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are~     sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic~     surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has~     been demonstrated by several authors using restrospective analyses. However, no prospective~     observational trial has been done to objectively evaluate cosmetic and oncologic outcome~     comparing BCT with iTOP. The aim of this study is to investigate this issue within a~     prospective non randomized observational trial at the Medical University Vienna.~   "
165690|NCT01396980|"~     -  SDF is validated by measuring changes in microcirculation in sepsis patients with MOF~          (Boerma studies).~        -  SDF is validated by measuring changes in microcirculation in stable chronic hemodialysis~          patients (NDT 2009 Bemelmans).~        -  Ultrafiltration in stable chronic hemodialysis leads to a decrease in sublingual~          microcirculatory flow (NDT 2009 Bemelmans).~        -  Trendelenburg position improves the sublingual microcirculatory flow at the end of~          hemodialysis treatment (NDT 2009 Bemelmans).~        -  Hemodialysis with ultrafiltration leads to a significant reduction of myocardial~          perfusion and cardiac output (NDT 2009 Dasselaar)~        -  Cardiac output measurement during dialysis is not practical.~        -  BVM is a validated method for hypotension due to ultrafiltration to prevent the amount~          of ultrafiltration online change based on the measured haemoconcentration (ref Dasselaar~          et al NDT 2005).~        -  BCM is a validated measurement to the dry weight in hemodialysis patients measured by a~          bioimpedance technique (NDT Passauer et al 2009).~   "
165691|NCT01396967|"~     During cataract operations a capsulorhexis is being performed. This is done in order to~     enable the removal of lens material while keeping the capsule intact in order to put inside~     the lens capsule an artificial intra ocular lens.~      The capsulorhexis must be round and with regular edge and no tears. While performing a~     cataract surgery we use phako emulsification machine that sends an ultrasonic wave that~     creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and~     sucks the fluid and the lens material of the creaked lens.~      The round shape and the regularity of the capsulorhexis are a must in these surgeries since~     the lens capsule must stay intact and stable in order to enable the phacoemulsification and~     the implant of the artificial lens.~      Today capsulorhexis are done with a bent needle or with special forceps; the act of~     capsulorhexis is delicate, sometime un predicted and difficult to teach. The learning curve~     is relatively long and difficult.~      The proposed device enables a capsulorhexis which is round and has regular edges, done almost~     automatically and is predicted. The learning curve is short and easy. The capsulorhexis is~     done through the original operating wound with no need to widen it.~   "
165692|NCT01396954|"~     Glucose metabolism disorders (GMD) can be present in an overt and a subclinical way. They~     have negative impact in survival of patients with liver cirrhosis (LC). Their prevalence has~     not been determined in compensated cirrhotic patients.~   "
165693|NCT01396941|"~     This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in~     comparison to normal sleep, will:~        1. Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the~          hyperinsulinemic-euglycemic clamp and oral glucose tolerance test.~        2. Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of~          endogenous glucose production, gluconeogenesis and glycogenolysis.~   "
165696|NCT01396902|"~     As a participant in these research program you will be a parent of a child born at Wesley~     Medical Center who plan to use Carriage Park Pediatric Clinic for your child's care. Mobile~     phone text messages will be sent to remind you of your child's immunizations.~      The long term research goal is to increase childhood immunization rates by improving parental~     health literacy through an innovative text messaging system regarding immunization schedules~     for children under the age of six.~   "
165697|NCT01396889|"~     Acute upper respiratory tract infections are the most commmon infections in children and are~     associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea~     is widely used for treatment of upper respiratoty tract infections. The aim of this study is~     to evaluate its efficacy as prophilaxis in children 1-5 years old.~   "
165698|NCT01396876|"~     The investigators hypothesized that the participation of therapeutic clowns in the pediatric~     emergency department procedure room would reduce anxiety, improve the level of cooperation~     children can provide and avoid some of the adverse effects.~   "
165699|NCT01396863|"~     The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration~     (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain.~      The study consist of two examination days placed one week apart. 12 HD patients will be~     recruited to the study. The patients will be randomly placed in two groups: Pre-dilution~     hemodiafiltration during the first examination and low flux hemodialysis during the second~     day or vice versa.~      Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments. The~     MRI-data will later be processed to estimate brain volume changes during the two types of~     treatment.~   "
165700|NCT01396850|"~     BBB dysfunction has been indicated in some groups of schizophrenia patients by measuring~     increased albumin and immunoglobulin (IgG) cerebrospinal fluid (CSF) levels. Most of the~     authors described a raised protein level in 5-20% of the schizophrenic patients (Muller &~     Ackenheil, 1995). Increased S100B levels were demonstrated in the serum of patients suffering~     from schizophrenia as well as depression, and this may reflect increased BBB permeability.~     Furthermore, this increase remains in those patients who develop a residual state with~     relevant negative symptoms, whereas S100B levels normalize in recovering patients (Shalev,~     Serlin & Friedman, 2009). CSF albumin and CSF IgG values correlate significantly with some of~     the SANS (Scale for the Assessment of Negative Symptoms) subscales and the SANS total score,~     this shows the correlation between BBB permeability and behavioral changes. It is important~     to say that although negative symptoms are often signs of chronicity of the disease, the~     abnormal CSF findings in Muller's experiment (1995) are not related to the duration of the~     disease, because the patients were quite young and the duration of the disease was less than~     3 years.~      The investigators hypothesize that a primary vascular pathology, which leads to BBB~     breakdown, will result a leakage of serum-derived vascular components in to the brain tissue~     and may cause brain dysfunction such as disturbed thinking processes, mood and behavior, as~     we can see in psychiatric patients.~   "
165701|NCT01396837|"~     The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in~     patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.~   "
165702|NCT01396824|"~     The purpose of this study is to determine whether nutritional status or body composition~     influences the prognosis of heart failure patients.~   "
165703|NCT01396811|"~     The purpose of this study is to determine if a topical antifungal cream is safe and effective~     for the treatment of tinea pedis.~   "
165704|NCT01396798|"~     Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill~     Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through~     prospective observational data collection concerning specific items from the clinical and~     technical examination in diagnosing serious infections, such as meningitis, sepsis,~     pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate~     a vital signs and symptoms rule derived from multiple low to high prevalent settings of~     acutely ill children.~   "
165705|NCT01396785|"~     The purpose of this study is to determine if a topical antifungal cream is safe and effective~     for the treatment of tinea pedis.~   "
165706|NCT01396772|"~     The purpose of this study is to determine if a 6-month community-based prediabetes lifestyle~     and behaviour change intervention (called, PREPARE) for middle and older adults with~     prediabetes will result in positive lifestyle behaviour change.~   "
165707|NCT01396759|"~     Continuous Positive Airway Pressure (CPAP) is a common form of support for patients admitted~     to Intensive Care Units (ICUs) of industrialized countries with respiratory distress (1).~     Nasal CPAP (NCPAP) is effective in correcting hypoxemia and contributes to reducing the~     number of children requiring endo-tracheal intubation and mechanical ventilation (2). CPAP is~     most frequently delivered to neonates using conventional mechanical ventilators, and thus~     there is minimal or no cost saving. There are other ways of delivering CPAP, such as~     Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an~     air-oxygen blender, a humidifier and a T-piece.(3). The expiratory arm is inserted in a~     bottle of water and the level of CPAP delivered is equivalent to the length of the expiratory~     tubing that remains under water. Robust equipment is now available at a fraction of the cost~     of mechanical ventilators. Bubble-CPAP has potential advantages over the mechanical~     ventilation, such as lower cost, ease of application by nursing staff, lower risk of~     complications, and has been proposed as an inexpensive method of delivering CPAP in~     developing countries (3).~      High flow air/oxygen mix is useful in reducing the indication of mechanical ventilation (4);~     however, there is a lack of randomized studies comparing it with bubble CPAP or with standard~     flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2 litre per~     kg per minute of blended air/oxygen mix, usually with a low fraction of inspired oxygen (say~     25-40%). It is easy to apply, but requires additional equipment to standard oxygen therapy,~     and closer monitoring. High flow delivers uncertain levels of CPAP, so it is not clearly~     superior to bubble-CPAP, and there have been no controlled comparative trials of these two~     techniques.~      Pneumonia and malnutrition are two of the most common co-morbidities in children in~     developing countries (5). In hospitals in resource-poor settings, children with severe~     malnutrition and pneumonia often present with respiratory distress with or without severe~     hypoxaemia and impending respiratory failure (6). They initially receive O2 supplementation~     through nasal prong or face mask. Support from bubble CPAP might help to effectively treat~     hypoxaemia, improve respiratory function, avoid the need for mechanical ventilation and its~     complications, and reduce mortality.~      Almost half of the patients admitted in the intensive care unit of the Dhaka hospital of~     ICDDR,B present with hypoxaemia, many with impending respiratory failure. Children with~     pneumonia also invariably have severe malnutrition with or without diarrhoea (Chisti MJ, MMed~     thesis, unpublished data). They often need mechanical ventilation, with attendant costs,~     complications and high mortality rates. However, no published data are available about the~     use of bubble-CPAP in children with pneumonia and malnutrition and there have been no~     controlled trials of CPAP in developing countries.~      The Hypothesis is:~      In children with severe pneumonia and hypoxaemia the probability of treatment failure (see~     definition below) will be significantly lower when respiratory support is initially provided~     by bubble-CPAP or high-flow, humidified air/O2 mix by nasal prongs, compared to standard~     oxygen flow.~   "
165708|NCT01396746|"~     The purpose of this study is to explore the relationship between cardiovascular function of~     persons with post stroke conditions and their performance in three field tests. This is a~     validation study, aiming to determine during which of two activities VO2 measurements better~     express the functional restrictions caused by stroke, And to find out whether the Total Heart~     Beat Index can be used in the case of stroke survivors for the prediction of mechanical~     efficiency when measured during stair-climbing and of energy cost during treadmill walking.~      The hypothesis is that Stair Climbing (STC) is a more suitable form of exercise capacity~     testing compared to Treadmill Walk (TMW) since it potentially requires a greater amount of~     external work, and therefore will show stronger correlation with functional tests~     demonstrating the same ability, whereas TMW does not utilize the movement capability of~     participants to the fullest.~      Another hypothesis is that cardiac response to the exertion can be used as a predictor of~     those measures during these exertions in the post stroke population.~   "
165709|NCT01396733|"~     Radioiodine (I-131) therapy is of proven efficacy for treatment of differentiated thyroid~     carcinoma (DTC). However, loss of differentiation in recurrent or metastatic DTC which~     decrease I-131 uptake may decrease the efficacy of I-131 therapy. Therefore, strategies to~     improve I-131 uptake are mandatory. This study is an open label clinical study to evaluate~     the effectiveness of alpha-lipoic acid (ALA) for improving I-131 uptake in recurrent or~     metastatic of DTC with defective I-131 uptake.~   "
165723|NCT01396551|"~     Clinical study investigating the feasibility and safety of using an anchored Calypso~     transponder in the airways of the lung for real-time monitoring of tumor location during~     radiotherapy~   "
165739|NCT01396343|"~     The purpose of this study is to better understand multiple sclerosis (MS) in children and~     adolescents, to learn if it differs from adult MS and to investigate if genes or~     environmental exposures or a combination of both put children and adolescents at risk for~     getting MS.~   "
165740|NCT01396330|"~     Introduction Stress is part of the investigators daily life, and means to cope with it allow~     adaptation and survival. To this end, physiological pathways are activated, including~     neuroendocrine, cardiovascular and metabolic responses. In short term, the majority of~     consequences are beneficial, in the long run, however, chronic psychosocial stress may~     constitute an increased risk for coronary heart disease, type 2 diabetes, and disability.~      Acute mental stress induces an exaggerated release of stress hormones e.g. catecholamine and~     cortisol which are thought not only to increase heart rate (HR) and blood pressure (BP) but~     also to increase blood glucose levels. In clinical practice, patients and health care~     providers are often confronted with questions concerning psychological stress as a possible~     reason for glucose fluctuations. Whether stress itself or poor treatment adherence is~     responsible for the altered glucose control remains often controversial. Differences in the~     inter- and intraindividual response to stress have been suggested, but only a few small~     studies have addressed the effect of acute psychological stress on glucose control in~     patients with diabetes. Patients with type 2 diabetes may overestimate the effect of acute~     psychological stress on glucose control but further studies are clearly needed to definitely~     exclude or confirm a relevant effect of stress on the glucose control in diabetic patients.~     For example, effects of longer lasting or repetitive events of psychological stress on~     glucose concentrations still remain elusive. The aim of the present study was therefore to~     investigate the effect of prolonged psychological stress by means of repetitive safe driving~     training courses on glucose control in patients with diabetes.~      Patients and Methods Forty patients with type 1 or insulin-treated type 2 diabetes attending~     the outpatient-clinic of the Kantonsspital Frauenfeld or University Hospital of Zurich for~     regular visits are invited to participate. Included are patients on any oral glucose-lowering~     treatment and at least one daily injection of insulin, a valid driver license and written~     informed consent given. Exclusion criteria are diabetes duration <2 years, pregnancy,~     unstable coronary artery disease, limited visual acuity or unstable proliferative diabetic~     retinopathy, uncontrolled hypertension (BP >160/95mmHg) and pituitary or adrenal disease. The~     Ethics committee of the Kanton Thurgau approved the protocol and the study conform to the~     principles outlined in the Declaration of Helsinki.~      Study protocol Each patient completes a control and a stress testing day which takes place~     consecutively in a randomized order. Randomization is performed by an uninvolved third~     person. The study is carried out at the driving training area of the Touring Club Switzerland~     at Hinwil. Patients are advised to have lunch before 12:00 a.m. and to abstain from food~     thenceforth. Drinking mineral water remains allowed during the entire study days, and the~     patients have to take their basal insulin and other medication as usual. Patients are advised~     to arrive at the driving training area between 2:30 and 3:00 p.m. At arrival, a capillary~     glucose measurement is carried out, and glucose concentrations ≥10mmol/l are corrected with~     short-acting insulin analogues (glucose target 6 - 8mmol/l). Subsequently, no additional~     adjustment with insulin is allowed during the study. Glucose concentrations ≤4mmol/l are~     always corrected with administration of 10g carbohydrate (DextroEnergy® or orange juice). On~     both study days, patients ingest a standard meal at 4:45 p.m. (i.e. 15min before the driving~     training). Immediately after the meal, short-acting insulin is injected in knowledge of the~     carbohydrate content (same dose on both days) or oral antidiabetics are ingested as usual.~     Measurements of capillary and plasma glucose concentration, blood pressure, heart rate,~     stress perception and salivary cortisol concentration are carried out in regular intervals~     between 4 and 9 p.m. on both study days.~      On the control day, patients are placed in a quiet room and are permitted to read. They also~     have the possibility to leave the room and stay on a balcony.~      On the stress testing day, patients complete a driving training with their car between 5 and~     7 p.m. The driving training consists of 3 consecutive exercises: first, a slalom track on dry~     and wet asphalt, secondly, a full braking exercise with water obstacles. Thirdly, the car is~     hurled around by a mechanical plate and the patients has to regain control over it.~   "
165710|NCT01396720|"~     Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute~     coronary events and coronary interventions. Several studies have shown that some patients are~     resistant to clopidogrel. The resistance mechanism is not entirely clear, but at least in~     part it is related to interactions between medications. Clopidogrel is a pro-drug converted~     in vivo to its active metabolite by CYP2C19 and CYP3A in the liver. Consequently drugs that~     inhibit the CYP2C19 can affect the production of the active metabolite and cause clopidogrel~     resistance. Therefore the FDA has recently published a safety alert which recommends~     avoiding cross treatment with clopidogrel and drugs that are expected to inhibit CYP2C19~     (including omeprazole, fluvoxamine, cimetidine, fluconazole and others). Nevertheless there~     no clear evidence in the literature for clinical relevance of such interactions.~      Selective serotonin reuptake inhibitors (SSRIs) are group of antidepressant drugs that are~     widely used for treatment of depression and anxiety. SSRIs are considered to be very safe~     with favorable side effect profile, hence many patient after coronary events who suffers from~     behavioral and emotional disturbances are treated with those drugs. However there are several~     reports that SSRIs can inhibit platelet function and increase bleeding tendency particularly~     in concomitant administration with aspirin. The proposed mechanism is blocking of platelets~     serotonin reuptake that result in platelet dysfunction.~      Fluvoxamine - is a member in the SSRI family and a potent inhibitor of the CYP2C19.~     Theoretically fluvoxamine should have two conflicting effects on the response to clopidogrel.~     Pharmacokinetically it is expected to decrease the clopidogrel responsiveness due to~     inhibition of CYP2C19 and reduction in the production of the active metabolite. On the other~     hand pharmacodynamically fluvoxamine may directly inhibit platelet aggregation due its~     effect on serotonin reuptake, thus increasing the effect of clopidogrel. Other SSRIs that do~     not interact with the CYP2C19 such as citalophram are expected to have only pharmocodynamic~     effect on platelet aggregation.~      Although both clopidogrel and SSRIs are widely used in the last decade and concomitant~     treatment is quite common, no data is available about in influence of the interaction between~     those drugs on platelet function and on clinical events. The net effect of fluvoxamine and~     other SSRIs on platelet function in the presence of clopidogrel is not known.~      The aim of the investigators study is to assess the effect of two SSRIs fluvoxamine and~     citalophram on platelet aggregation and to test the effect of these drugs on the laboratory~     response to clopidogrel, in healthy individuals.~      Study design: randomized, double blinded, controlled crossover trial. Primary study end~     point: Change in % platelet aggregation and VASP phosphorylation after treatment with~     clopidogrel + fluvoxamine or clopidogrel + citalophram as compared to each drug alone.~   "
165711|NCT01396707|"~     This is an open-label, multicentre, prospective phase II trial designed to evaluate the~     efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as~     first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma~     of the stomach or gastro-oesophageal junction.~   "
165712|NCT01396694|"~     All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction~     will complete a psychological questionnaire prior to surgery. The 3 month outcomes including~     pain and function will be examined using regression analysis to identify psychological~     variables that may predict outcomes.~   "
165713|NCT01396681|"~     This is a phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy~     Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer.~   "
165714|NCT01396668|"~     This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by~     chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.~   "
165715|NCT01396655|"~     Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy~     differ from those of early breast cancer.~      The purpose of this study was to identify the clinical significance of potential predictive~     and prognostic factors including serial FDG PET/CT in breast cancer patients treated by~     neoadjuvant chemotherapy.~   "
165716|NCT01396642|"~     Almost all (99%) of the neonatal deaths occur in lower and middle income countries. Most of~     these deaths are attributable to prematurity and infection. With the increasing rate of~     premature births in some settings, the mortality rate of over 50% among preterm babies in~     some of the developing countries require inexpensive hospital-based strategies to prevent~     fatal infections in newborns of these countries. As most of the deaths in preterm neonates~     are attributable to their vulnerability of infection, a potential low cost intervention like~     topical emollient therapy can be effectively directed to reduce infection related mortality~     and morbidity in the developing countries. Topical emollient therapy reduces the rate of~     infection by enhancing the skin barrier function, thus reducing trans-epidermal water loss~     consequently conserving heat and energy to promote growth.~      The broad goal of the study is to improve the survival rate of hospitalized preterm neonates~     in the developing countries by decreasing the incidence of infection using low-cost~     interventions.~      HYPOTHESIS:~      It is hypothesized that topical emollient therapy with coconut oil twice a day till 28th day~     of life in hospitalized preterm neonates reduces the incidence proportion of hospital~     acquired infection by 40% 15 as compared to routine skin care. For the secondary objective it~     is hypothesized that the weight gain in the neonates receiving prophylactic application of~     emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day18~     more as compared to the weight gain in the routine skin care group.~   "
165717|NCT01396629|"~     The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the~     implantation of foldable intraocular lenses.~   "
165718|NCT01396616|"~     The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational~     stability after implantation of TORIC IOL and to assess the post operative complications~     after implantation of TORIC IOL.~   "
165719|NCT01396603|"~     This study will evaluate a new imaging technology, termed optical frequency domain imaging~     (OFDI) for detecting and diagnosing pulmonary malignancy in the central airways.~   "
165720|NCT01396590|"~     The purpose of this study is to determine that six 2-mg tablets of perampanel are~     bioequivalent to one 12-mg tablet of perampanel.~   "
165721|NCT01396577|"~     The purpose of this study is to determine that three 2-mg tablets of perampanel are~     bioequivalent to one 6-mg tablet of perampanel.~   "
165722|NCT01396564|"~     HYPOTHESIS: Treatment with pioglitazone is more effective in reducing resistin concentrations~     and insulin resistance than metformin in children with Type 2 Diabetes (T2D).~      MATERIAL AND METHODS: Pediatric patients aged 8-17 with T2D as defined by the American~     Diabetes Association (ADA) were included, not under treatment or who had been treated~     exclusively with diet and exercise or who only received an anti-diabetic agent, as well as~     those with a history of insulin use who had not applied insulin within 1 month before the~     initial visit. History of T2D, hypertension, exercise, diet, age, gender and somatometry are~     recorded. A Blood sample is taken to determine HbA1c, glucose, insulin and resistin.~      STATISTICAL ANALYSIS: The percentual change over 4 weeks is analyzed for concentrations of~     resistin, insulin resistance. Changes are noted for weeks 12, 24, 36 and 48 for resistin~     concentrations, HbA1c and HOMA values. Baseline and final values are compared with a paired t~     test. Lineal or logarithmic regression analysis is used to evaluate the relationship between~     homeostasis model assessment of insulin resistance (HOMA-IR) and resistin concentrations. The~     statistical significance between variables is determined using ANOVA. The effect of~     confounding variables is analyzed with a test of co-variance analysis. Statistical~     significance is considered as p <0.05.~   "
165724|NCT01396538|"~     Atni-HBs to HBsAg and Anit-HBc was interpreted based on three hepatitis markers for clinical~     detection of HBV-infections. HBAg and Anti-HBs were negative and the Anit-HBc-positive~     referred to as Anti-HBc alone. When the Anti-HBc alone occurs, patients may be due to~     mutations in HBV HBsAg can not be detected due to (1), but if by the molecular diagnostics by~     polymerase chain reaction (PCR) technology can detect HBV DNA present. When Anti-HBc alone in~     patients with serum HBV DNA can be measured, then there may be occult HBV infection. In~     different countries, Occult HBV infection in the Anti-HBc Alone group had significant~     differences in the prevalence (2.9 ~ 22.8%) (2), but prevalence survey in Taiwan there are~     very few studies on this , It is hoped to be able to investigation the prevalence of occult~     HBV infection Among Anti-HBc Alone.~   "
165725|NCT01396525|"~     To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable~     Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native~     common iliac artery and/or native external iliac artery.~   "
165726|NCT01396512|"~     The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus~     Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine~     [CD.JEVAX™]) after a single dose vaccination to support product registration.~      Primary Objective:~        -  To demonstrate the non-inferiority of the antibody response 28 days after administration~          of one dose of IMOJEV™ compared to the antibody response 28 days after administration of~          one dose of the CD.JEVAX™ control vaccine.~      Secondary Objectives:~        -  To describe the immune response to Japanese encephalitis (JE) in both vaccine groups~          using 50% plaque reduction neutralization assay (PRNT50) assays before and after a~          single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.~        -  To describe the safety of vaccination in all subjects up to 28 days and all serious~          adverse events up to 6-month after vaccination.~   "
165727|NCT01396499|"~     The goal of this clinical research study is to find the highest tolerable dose of BKM120 that~     can be given to patients with relapsed or refractory leukemia. The safety of BKM120 will also~     be studied.~   "
165728|NCT01396486|"~     The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus~     inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3~     fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the~     side effect profile of omega-3 fatty acids plus inositol. This study will be a 12-week trial~     with children ages 5-12 years old with bipolar spectrum disorders.~   "
165729|NCT01396473|"~     The purpose of this study is to design and conduct research to tailor out of school time~     evaluation materials so they are applicable to various settings in Boston, are efficient in~     that minimal resources and time are used, and are useful to participants.~   "
165730|NCT01396460|"~     Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of~     energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental~     and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a~     decrease in the values of RQ, which may be associated with increased lipid oxidation in the~     postoperative period.~      Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would~     like to know how it functions among RYGBP patients.~      The purpose of this study is to evaluate the RQ and DIT of patients in the post operative~     phase and compare the result with a control group consisting of morbid obese population.~   "
165731|NCT01396447|"~     The objective of this study was to evaluate the efficacy, safety, and tolerability of~     cariprazine relative to placebo for the treatment of participants with bipolar depression.~   "
165732|NCT01396434|"~     Prevenar 13 is safe for administration to Filipinos.~   "
165733|NCT01396421|"~     The purpose of this study is to compare the effectiveness, safety and tolerability of three~     different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.~   "
165734|NCT01396408|"~     This research is being done because there is no treatment that will cure this type of cancer.~     Although some types of chemotherapy can cause this cancer to shrink for a time, better~     options are needed.~   "
165735|NCT01396395|"~     This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart~     Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who~     are taking standard treatment with stable symptoms will receive a 24-hour ambulatory~     electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups.~     The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of~     the standard treatment for 12 weeks, while the control group will stay on standard treatment.~     Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not~     affect the primary endpoint may be adjusted per investigators decision.~   "
165736|NCT01396382|"~     Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The~     68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and~     resolution specifically for neuroendocrine tumors. The investigators will scan people with~     this cancer and compare it to other conventional imaging methods to see if it improves~     patient care.~   "
165737|NCT01396369|"~     PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone~     levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the~     ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require~     2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum~     hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic~     ovaries.~      This study is a prospective randomized pilot study designed to evaluate the effects of~     flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in~     polycystic ovarian syndrome (PCOS) patients.~   "
165738|NCT01396356|"~     You are being scheduled to undergo an ablation procedure to treat your atrial fibrillation.~     Complications of ablation procedures include damage to structures near the heart from the~     heat energy used during the ablation procedure. These complications include damage to the~     esophagus (the tube through which food passes when you swallow) and stomach. A rare but often~     fatal complication resulting from severe heat damage is called an atrio-esophageal fistula~     (an abnormal connection between the heart and esophagus). However, the frequency of minimal~     damage to the esophagus or nerves of the gut that may go unnoticed are not known.~      This study is designed to determine how often atrial fibrillation ablation causes problems~     with the stomach and esophagus.~   "
165742|NCT01396304|"~     Calcium alginate dressings with silver have been found to be safe and effective for use for~     leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to~     AqualCel Ag Dressing on the following parameters: No further progression toward infection~     (bioburden), ease of application and removal, and percent progression to closure. The~     secondary objective is to obtain photographic documentation of the leg ulcers during the~     course of the study.~   "
165743|NCT01396291|"~     This study is being done to evaluate the efficacy and safety of asenapine as compared to~     placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic~     mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each~     participant will receive open-label asenapine and matching placebo for 12 to 16 weeks.~     Participants who meet stabilization criteria may then be randomized into one of the two study~     arms (asenapine or matching placebo) to receive double-blind treatment for up to an~     additional 26-weeks.~   "
165744|NCT01396278|"~     The aim of the study is to assess and compare efficacy and safety of BI 54903 at three~     different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose~     inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d.~     over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately~     controlled medium dose ICS therapy as demonstrated by a decrease in forced expiratory volume~     in one second (FEV1) range 10 to 25 % and an asthma control questionnaire-6 (ACQ-6) equal or~     greater than 1.5 at time of randomisation.~   "
165745|NCT01396265|"~     The objective of the current study is to investigate the effect of the P-gp inducer~     rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers~   "
165746|NCT01396252|"~     The purpose of this clinical study is to assess the safety and tolerability of multiple oral~     doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.~   "
165747|NCT01396239|"~     This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics~     (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24~     weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).~   "
165748|NCT01396226|"~     Medical Products Agency~   "
165749|NCT01396213|"~     A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and~     safety of Larazotide Acetate in the treatment of patients with celiac disease who have~     persistent symptoms despite being on a gluten-free diet.~   "
165750|NCT01396200|"~     The purpose of this study is to determine the feasibility of giving (i) rapamycin or (ii)~     hydroxychloroquine (HCQ), with standard doses of infusional cyclophosphamide and pulse~     dexamethasone (cy/dex) for patients with relapsed/refractory multiple myeloma, as well as the~     feasibility of obtaining multiple blood and bone marrow samples during treatment to assess~     the pharmacodynamic effects of the treatment.~   "
165751|NCT01396187|"~     This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability~     and pharmacokinetics of multiple ascending doses of PF-05231023.~   "
165752|NCT01396174|"~     The investigators hypothesize that breast cancer survivors participating in a prosocial~     online support group will have a significantly lower mean level of psychological symptoms~     (anxiety/depression) and higher mean level of sense of purpose post-intervention than~     participants in a standard online support group.~   "
165753|NCT01396161|"~     The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics~     and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and~     patients with type 2 diabetes mellitus.~   "
165754|NCT01396148|"~     Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with~     sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be~     studied in these patients. In addition, tumor responses and overall survival will be~     assessed.~   "
165755|NCT01396135|"~     This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The~     pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be~     evaluated in Japanese, healthy, non-smoking subjects.~   "
165756|NCT01396122|"~     The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE~     PROSIMA* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ~     Prolapse.~   "
165757|NCT01396109|"~     Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms~     such as loss of control of the bowel or bladder, and may also cause problems with patient's~     sex life. The primary treatment is surgery, sometimes a mesh is placed in the pelvis to~     support the weakened tissues, but mesh implants can cause complications.~      This study is designed to determine the effectiveness and safety of GYNECARE PROSIMA* pelvic~     floor repair system compared with the modified total pelvic floor reconstructive surgery with~     mesh for the treatment of uterine prolapse.~      Patients enrolled into the study will be followed up for up to 3 years after surgery.~     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before~     and after surgery, patient satisfaction through quality of life and sexual function~     questionnaires before and after surgery, and peri-operative complication rates will be~     evaluated.~   "
165758|NCT01396096|"~     This proposal is designed to (1) establish the feasibility of a research strategy for~     discovering ethnic differences in the frequency of genotypes in patients after bariatric~     surgery and (2) perform a preliminary evaluation of this research strategy. Our goal is to~     identify genetic factors that may influence the success of various surgical weight loss~     interventions and determine whether these factors are associated with specific patient~     populations.~   "
165759|NCT01396083|"~     This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone~     implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a~     pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with~     sham injections PRN afterwards.~   "
165760|NCT01396070|"~     The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an~     investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically~     mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options,~     the treatments are associated with short response duration, thus this condition is largely~     incurable. This investigational drug may offer less toxicity than standard treatments and~     have better tumor specific targeting.~   "
165761|NCT01396057|"~     This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone~     implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a~     pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with~     sham injections PRN afterwards.~   "
165762|NCT01396044|"~     Medical errors account for tens of thousands of deaths and tens of billions of dollars in~     healthcare costs in the United States every year. One field that has seen the strongest push~     toward quality improvement has been critical care medicine, likely because its particularly~     high degree of medical complexity makes it a practice area prone to high error rates with~     serious consequences. One of the most commonly used interventions used to help reduce errors~     in the intensive care unit (ICU) has been the implementation of checklists.~      The investigators propose a clinical trial in a University critical care setting to determine~     whether an electronic checklist versus verbal prompting to use a written checklist improves~     clinical practice and patient outcomes. The investigators also plan to compare these data~     with a time period prior to the study to determine if the electronic checklist or verbal~     prompting are better than usual care. The investigators hypothesize that both the electronic~     checklist and verbal prompting to use a written checklist will be better for clinical~     practice and patient outcomes than usual care, and that verbal prompting will lead to better~     outcomes compared to the electronic checklist.~   "
165763|NCT01396031|"~     Blood and marrow transplantation (BMT) is commonly used in the treatment of oncologic and~     hematologic disorders. Patients undergoing Hematopoietic stem cell transplantation (HSCT) are~     screened for functional status among other criteria to ensure that they are able to endure~     the rigorous treatment involved during Hematopoietic stem cell transplantation (HSCT). The~     patient entering the transplant process is possibly already functionally compromised from~     their disease, prior cancer treatment, and possible other co-morbidities. Additional factors~     of the transplantation that compromise the independent functional status of the patient~     include the high dose preparative regimen, pancytopenia, steroid-related side effects,~     hospitalization, transplantation complications such as infections, pulmonary alterations,~     acute and chronic Graft-versus-host Disease (GVHD), pain, decreased nutritional input, and~     other sequelae of transplantation.~      Physical Therapy has been utilized in this population primarily as a supportive therapy to~     prevent and limit the patient's functional decline. Studies have addressed general and~     aerobic exercise in this population but there is a paucity of research investigating the~     benefits of a strength-training program, particularly performed in weight-bearing, in~     attenuating the detrimental effects of the transplantation on functional status.~      This is a feasibility study questioning if an exercise program including weight-bearing~     strengthening exercises and cardiovascular exercise is practical for the patients to carry~     out as inpatients. The study will also preliminarily determine if this exercise program~     influences functional outcomes and level of fatigue. Such outcome measures will include 1)~     FiveTimes Sit-To-Stand Test, 2) Six-Minute Walk Test, 3) stair performance, 4) Functional~     Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) and Functional Assessment~     of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scales.~      The study population will include patients with lymphomas and acute leukemias undergoing~     matched-related donor allogeneic myeloablative Blood and marrow transplantation (BMT).~   "
165764|NCT01396005|"~     In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will~     be given boceprevir. Blood samples will be taken at specified intervals to find out whether~     boceprevir affects the pharmacokinetics of methadone, buprenorphine, or naloxone.~   "
165765|NCT01395992|"~     Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for~     eligibility for this 26-week extension study in which they will continue treatment. The~     primary purpose of this trial is to evaluate the long-term safety of asenapine.~   "
165766|NCT01395979|"~     Brief Summary: The specific aims of this study are:~        1. To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing~          therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in~          HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual~          abuse (CSA). The primary outcome is reduction in unprotected anal/vaginal intercourse~          (number and proportion) with serodiscordant partners. The investigators will also~          examine the intervention effect on CSA-related trauma symptom severity and cognitions~          and behaviors.~        2. To examine the degree to which intervention-related reductions in sexual risk behavior~          are mediated by reductions in CSA-related symptom severity, cognitions, and behaviors.~        3. To examine the degree to which the intervention reduces incident sexually transmitted~          infections (STIs) during the study period, as well as to explore additional potential~          moderators and mediators of intervention efficacy.~      Study hypotheses:~        1. For the primary outcome, the investigators hypothesize that those who receive the~          intervention will have reduced transmission-risk behavior.~        2. For the secondary outcome, the investigators hypothesize that those who receive the~          intervention will have reduced trauma symptom severity (cognitions and behaviors).~   "
165767|NCT01395966|"~     The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and~     effective in treating middle ear infections in children with ear tubes.~   "
165768|NCT01395953|"~     The main objective of this exploratory 8 week pilot study is to evaluate the safety and~     efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism~     spectrum disorders. The study results will be used to generate hypotheses for a larger~     randomized controlled clinical trial with explicit hypotheses and sufficient statistical~     power.~   "
165769|NCT01395940|"~     The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with~     endometriosis.~   "
165770|NCT01395927|"~     The purpose of this study is to evaluate blood levels of canagliflozin in healthy volunteers~     before and after the administration of multiple-doses of rifampin.~   "
165771|NCT01395914|"~     The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia~     (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.~   "
165772|NCT01395901|"~     The primary objective of this study is to evaluate the efficacy of a single palonosetron IV~     dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and~     vomiting through 24 hours after surgery in children aged from neonates up to less than 17~     years undergoing elective surgical procedures requiring general intravenous anesthesia. The~     secondary objective is to evaluate the safety and tolerability of IV palonosetron in~     pediatric patients.~   "
165800|NCT01395537|"~     RATIONALE: Since lapatinib inhibits both EGFR and HER2 receptors, it is an attractive agent~     for the treatment of esophageal and GEJ tumors.~      PURPOSE: Lapatinib is currently approved for HER2 positive metastatic breast cancer in~     combination with capecitabine or letrozole. It is hoped that by giving lapatinib and~     carboplatin and paclitaxel together, their combined effects will further slow or stop the~     cancer cells from growing.~   "
165773|NCT01395888|"~     This study is designed to evaluate the effect of fluticasone furoate (FF,~     GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness~     compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic~     pulse wave velocity (aPWV) > 12.0 m/s at Visit 1. Arterial stiffness will be measured as~     aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group,~     multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the~     randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment~     period. There will be an approximate 7-day Follow-up period after the treatment period.~   "
165774|NCT01395875|"~     Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all~     diagnosed COPD patients. Yet limited data exists on characterizing this study population in~     terms of drug therapy patterns and COPD-related resource use and costs. The objective of the~     following study was to conduct an analysis in the real-world setting to (1) identify and~     characterize COPD patients with moderate exacerbations and (2) evaluate the impact of~     initiating different maintenance therapies in this population. Maintenance therapy~     medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs),~     combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and~     ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium~     [IPR]).~   "
165775|NCT01395862|"~     The purpose of this study is to detect adverse drug reactions for long-term use (particularly~     clinically significant adverse drug reactions) occurring in clinical settings, to examine~     factors likely to affect the safety and efficacy in the Japanese asthma patients who are~     treated with fluticasone propionate/salmeterol xinafoate.~   "
165776|NCT01395849|"~     The purpose of this post-marketing surveillance is to detect adverse drug reactions~     (particularly clinically significant adverse drug reactions) occurring in clinical settings,~     to examine factors likely to affect the safety and efficacy in the Japanese asthma patients~     treated with fluticasone propionate and salmeterol xinafoate.~   "
165777|NCT01395836|"~     One common occurrence following open heart surgery is an irregular rhythm from the top~     chambers of the heart known as atrial fibrillation (afib or AF). It is known that about 30%~     of patients who have had bypass surgery without having a heart valve replaced at the same~     time will develop AF. It is felt that this occurrence leads to factors that will affect a~     subjects health for the rest of their life. In studying this the investigators will see if~     post operative afib is an indicator of a person having afib and is not a condition that may~     only last during the post op recovery period as many physicians feel.The problem in question~     is, is post operative afib only transient or is it an indicator for more long term episodes~     of afib that may lead to other health concerns like stroke. Fifty subjects will be asked to~     participate. There will be to groups of 25 subjects. All subjects will have a device~     implanted under the skin that will be able to detect all types of heart rhythms. One group~     will get standard treatment and the physicians will be blinded to the recordings. The other~     group will be treated by the recording and the information about the amount of time in afib.~     The purpose of the study is to determine what the true occurrence of afib is for the first~     year after open heart surgery and to see if knowing this will alter the clinical management~     of this group of subjects.Currently most subjects are treated without knowing this~     information and based on that the arrhythmia will no longer happen after the heart is healed~     or recovered from the surgery. Most medications for controlling the heart rate and rhythm are~     stopped around 3 months. There is also a tendency to not to use blood thinning medications~     for the prevention of stroke after this time period. Stroke is one of the major complications~     from afib. Not all subjects are aware of the irregular heart beats so you can not depend on~     them to accurately know. They might feel episodes of very fast beating episodes or may become~     weak and fatigued. Weakness and fatigue are also normal during the first parts of recover~     from bypass surgery. By documenting the true episodes of afib the investigators can better~     understand if postoperative afib might need to be treated as a life long issue rather than a~     transient post operative issue. This treatment might change clinical management and decrease~     mortality.~   "
165778|NCT01395823|"~     A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D~     supplementation, but only one of these is a prospective clinical trial, and it is a small,~     single center study lacking a control arm. The investigators propose to conduct a double~     blind, randomized, placebo controlled clinical trial of ergocalciferol supplementation to~     confirm safety and determine effects on Erythropoietin (EPO) dosing, active D dosing, and~     mineral metabolic parameters in hemodialysis patients.~   "
165779|NCT01395810|"~     This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to~     evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term~     exposure in patients with haemophilia B.~      This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773~     (NCT01386528/paradigm™ 3).~   "
165780|NCT01395797|"~     The goal of the proposed research is to improve the effectiveness of treatments for opioid~     and for nicotine dependence by testing a novel pharmacological strategy. Specifically,~     pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be~     used as an adjunct to agonist-based treatment.~   "
165781|NCT01395784|"~     The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been~     characterized in a controlled laboratory setting. Accordingly, the proposed investigation~     seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused~     opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this~     investigation is to characterize the subjective effects of oxycodone under maintenance on~     various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers.~     Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive,~     and physiological effects of oxycodone.~   "
165782|NCT01395771|"~     The adherence rate (95%) to HAART in the intervention group which receives a phone call will~     be higher than that(75%)of control group which does not receive a phone call.~   "
165783|NCT01395758|"~     The purpose of this study is to evaluate progression-free survival among subjects with KRAS~     mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib~     (ARQ 197) compared to single agent chemotherapy.~   "
165784|NCT01395745|"~     The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod~     administered in addition to standard therapy in subjects with active Systemic Lupus~     Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable~     corticosteroid therapy.~   "
165801|NCT01395524|"~     The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of~     opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.~   "
165812|NCT01395381|"~     The benefit of anti-worm therapy as part of the case management of severe acute malnutrition~     (SAM) in the outpatient setting has not previously been studied. This study will compare~     recovery rates of children with SAM treated in the community with locally-produced~     ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their~     case management.~   "
165785|NCT01395732|"~     The effect of bosentan on digital ulcers (DU) was studied in two randomized~     placebo-controlled trials (RAPIDS-1 and RAPIDS-2). A limitation of these studies was the~     heterogeneous study population. More importantly, there were no endpoints that assessed~     changes in vasculopathy and / or perfusion. Laser Doppler imaging has been shown to~     effectively demonstrate blood flow restrictions in the hands of patients with Systemic~     Sclerosis (SSc). The relation between blood flow restriction in the hands measured by laser~     Doppler imaging and the extent of DU disease has not been studied. The current study will~     attempt to demonstrate this relation. In addition, the impact of bosentan on the blood flow~     in the hands, in a defined cohort of SSc-DU patients with a history of DU within the past 2~     years and a clinically relevant reduction of blood flow in the hands, will be assessed.~   "
165786|NCT01395719|"~     The purpose of this study is to determine whether remote ischemic conditioning can improve~     the outcome after renal transplantation with deceased donor. Remote ischemic conditioning is~     performed on the patient receiving a kidney from a deceased donor. Remote ischemic~     conditioning is done during the operation by inflating a tourniquet on the patients leg~     before opening the blood circulation to the kidney. The study focus on both the immediate~     kidney function after the transplantation, but also on the extended kidney function one year~     after the transplantation.~   "
165787|NCT01395706|"~     Objectives of Clinical Trial~      The main objective of this clinical trial is to show the efficacy of fluorescence~     lymphangiography with indocyanine green (ICG) for the detection of sentinel lymph nodes.~   "
165788|NCT01395693|"~     Assessment of the performance of the Salt Lake mask system acting as a patient interface in~     the provision of PAP therapy. This study will assess the suitability of this mask system in~     its current form for use.~   "
165789|NCT01395680|"~     Family resilience is an important strength to help family to manage life challenge~     successfully, and to reorganize family function. However, few studies have showed the~     trajectory of family resilience in adolescents with cancer over time. The purposes of this~     study are to know the trend of family resilience in adolescents with cancer from previous 3~     months to the first year of newly diagnosed, and to examine the relationships among family~     members' stress, family satisfaction, and family resilience in adolescents with cancer.~   "
165790|NCT01395667|"~     In this phase I trial neoadjuvant CCRT combining IMRT with three escalated dose levels (45~     Gy, 50 Gy, and 55 Gy in 25 fractions) and BV-fluorouracil/ leucovorin/oxaliplatin (FOLFOX)~     regimens is planned for 15 locally advanced rectal cancer patients. The primary goal is to~     define the maximally tolerated dose of radiotherapy and the treatment related acute toxicity,~     and to demonstrate that preoperative highly conformal IMRT and concurrent BV-chemotherapy~     will lead to acceptable acute gastrointestinal morbidity. The secondary goal is to~     demonstrate that this treatment modality will elicit a comparable or improved rate of T stage~     downstaging and complete response pathologically.~   "
165791|NCT01395654|"~     Despite the availability of effective anti-tuberculosis agents that exist to treat this~     illness, hepatotoxicity during first-line drugs anti-tuberculosis medications (ATT) such as~     isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) is not uncommon and limit their use.~     There is no consensus on method of the reintroduction of anti-TB medications. The risk of~     reintroducing of a anti-TB medications could be hazardous. There are several differences~     between the guidelines from the ATS, BTS and the Task Force of the European Respiratory~     Society, the WHO and the International Union Against Tuberculosis and Lung Disease about the~     methods of reintroducing of anti-TB medications.~      The investigators plan to do a prospective study to evaluate the outcome and safety of~     reintroduction of anti-TB medications after resolution of hepatitis during anti-TB treatment~     among TB patients in the investigators hospital.~   "
165792|NCT01395641|"~     This Phase I/II trial is to prove the efficacy and safety of AAV2-hAADC to treat patients~     with AADC deficiency.~   "
165793|NCT01395628|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about cancer and the development of drug resistance in patients.~     It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial is studying samples from patients with leukemia.~   "
165794|NCT01395615|"~     This observational study will assess the health related quality of life (HQRL) profiles of~     patients with chronic lymphocytic leukaemia. Using health assessment questionnaires, data~     will be collected from patients currently receiving therapy and from those who have finished~     therapy and have undergone an assessment of treatment.~   "
165795|NCT01395602|"~     The aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine~     receptor agonist, on body weight and blood glucose in healthy obese adults.~      This is a randomized double-blind placebo controlled study. Twenty subjects each will be~     randomly assigned either placebo or cabergoline for 16 weeks.~      The effect of treatment on body weight and blood glucose and insulin levels will be compared~     in the treatment versus the placebo arm.~   "
165796|NCT01395589|"~     The role of vitamin D in respiratory health remains uncertain. Whether vitamin D reduces~     clinically important exacerbations of childhood asthma remains uncertain. We compared rapid~     to maintenance vitamin D repletion analyzed by baseline vitamin D level.~   "
165797|NCT01395576|"~     Post stroke patients often suffer from decrease in strength, loss of balance and gait~     asymmetry. Accordingly, these patients are at high risk for falls and fall-related injury.~     The presence of spastic or retracted muscles, e.g. the ankle plantar flexors or the~     quadriceps in combination with hamstrings weakness, causes knee hyperextension, which~     increases the stance phase duration and makes it difficult to achieve symmetrical gait.~     Additionally, this gait disorder can be painful as a result of stress to the ligaments and~     tendons at the posterior aspect of the knee.~      The Genu Neurexa orthosis is designed to stabilize the knee, enable balance control and~     prevent hyperextension. In order to assess the effect of the orthosis on the gait and balance~     characteristics of stroke patients the investigators will conduct subjective patient's~     satisfactory questionnaire, complete physical and functional evaluation and gait analysis, as~     well as dynamic electromyography (EMG) muscle activation patterns. These examinations will be~     performed 3 times: at the beginning of the trial, after one month and after two months. The~     trial design is explained in the following paragraph.~      The investigators hypothesize that the gait pattern will be improved while using the knee~     orthosis,as will be expressed by smaller base width and faster walking velocity etc.~   "
165802|NCT01395511|"~     The purpose of this study is to determine whether acupuncture is effective and safe~     therapeutic method in the treatment of cervical pain, shoulder and upper extremity pain and~     discomfort due to Whiplash associated disorder. (Traumatic car accidents)~      We recruit 40 participants who had cervical, shoulder and upper extremity pain and had~     discomfort due to Whiplash associated disorder. And then we check initial data of 40~     participants (Pain;VAS, Cervical ROM, SF-36, SDS, CMI)~      40 participants were randomly allocated to two groups ; acupuncture group or waiting-list~     group.~      Acupuncture group: participants were given acupuncture treatment three times a week during 2~     weeks, for 15 minutes at each session. After 6 times acupuncture treatments, we check~     information of participants again after 2 weeks(VAS, ROM, SF-36, SDS, CMI)~      Waiting-list group : The waiting-list group did not receive acupuncture treatment. After 2~     weeks we check information of participants again (VAS, ROM, SF-36, SDS, CMI)~      The waiting-Patients in both groups were permitted to receive usual care including physical~     therapy and exercise and were not permitted to take analgesics and antiphlogistics during the~     trial periods.~   "
165803|NCT01395498|"~     The purpose of this study is to determine the incidence of the carriage state (asymptomatic~     colonization) with Pneumocystis Jirovecii (Pneumocystic Carinii Pneumonia, PCP) and~     Cytomegalovirus (CMV)in the human lung. These are pathogens causing pneumonia in patients~     with suppressed immune system, but not known to cause disease in otherwise normal people. The~     investigators hypothesis is that a carriage state exists for these two pathogens. To test~     this hypothesis the investigators will examine bronchoalveolar lavage fluid for genetic~     material of these two pathogens. The study population will be patients undergoing fiberoptic~     bronchoscopy and lavage for indications other than diagnosis of a presumed opportunistic~     infection.~   "
165804|NCT01395485|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in~     adolescent and adult subjects with intermittent or mild to moderate persistent asthma.~   "
165805|NCT01395472|"~     The aim of this study is to determine the effects of an acute session of physical exercise on~     cognitive functioning and humor of traumatic brain injury patients and to investigate whether~     different cognitive responses can be achieved with different intensities of exercise~     (moderate and vigorous).~      The investigators hypothesize that while moderate intensity physical exercise may be~     beneficial to cognitive functioning, vigorous intensity may be detrimental to TBI patients,~     as physical fatigue may impair alertness and other higher cognitive functions.~   "
165806|NCT01395459|"~     Parent study:~      A Coordinated Approach to Cancer and Health (CATCH), was designed to compare the efficacy of~     two intervention arms (described below) intended to increase breast, cervical, and colon~     cancer screening rates among patients served by community health centers. A central focus of~     CATCH is to evaluate sustainable strategies for maximizing cancer screening rates among~     populations facing significant cancer disparities.~      CATCH was conducted in partnership with the large health clinic in Massachusetts, which~     serves a largely Hispanic low income population. Focusing on the use of an Interactive Voice~     Response (IVR) telephone technology system, the study is examining the extent to which the~     IVR, when developed in a culturally sensitive and appropriate manner (focus groups will be~     conducted to inform the intervention), can improve breast, cervical and colon cancer~     screening rates compared to a control group. Furthermore, we plan to determine if pairing IVR~     with telephone calls from a prevention care coordinator (PCC) will result in higher screening~     rates (when compared to the IVR only group). We will determine the cost-effectiveness of IVR~     alone vs. IVR + PCC.~      Substudy:~      We conducted a substudy of the parent study, looking at a comparison of return rates of two~     colorectal cancer screening home test kits: Fecal Occult Bood Tests (gFOBTs) and Fecal~     Immunochemical Tests (FITs). As well we surveyed people who pick up one of these two types of~     tests to assess barriers and facilitators of returning the completed kit to the health center~     for assessment.~   "
165807|NCT01395446|"~     The purpose of this study is to establish the accuracy with which the eNose can discriminate~     patients with invasive pulmonary aspergillosis from controls.~   "
165808|NCT01395433|"~     This is a bioequivalence study, which is a regulatory requirement to ensure comparable in~     vivo performance, i.e. similarities in terms of safety and efficacy, after administration of~     two different dosage forms of escitalopram.~      All subjects will receive three separate dosages of 20 mg escitalopram, which are 2 x 10 mg~     of the conventional dosage form (Treatment A) and 2 x 10 mg of the new dosage form being~     tested (Treatment B) and 1 x 20 mg of the new dosage form being tested (Treatment C). Test~     treatments B and C will each be compared to Treatment A, which is the active comparator~     (reference formulation).~   "
165809|NCT01395420|"~     This is an open-label study divided in 2 parts and 3 cohorts to determine the concentration~     of Avibactam and Ceftazidime in the lining of the lungs and the blood.~   "
165810|NCT01395407|"~     Brain metastases are the most common adult intracranial tumor, occurring in approximately 10%~     to 30% of adult cancer patients, and represent an important cause of morbidity and mortality~     in this population. The standard of care for solitary brain metastasis is surgery followed by~     whole brain radiation therapy (WBRT). Without WBRT, there are unacceptably high levels of~     local failure that occur. Local recurrence rates ranged from approximately 45% at 1 year to~     60% at 2 years after resection alone. However, aside from improvements in intra-cranial~     control, it is well documented that WBRT is associated with serious long term side effects,~     including significant decline in short term recall by as early as 4 months after treatment.~      Many centers are now offering patients stereotactic radiosurgery (SRS) to the cavity after~     resection alone to improve local control while avoiding the negative effects of WBRT. There~     have been several retrospective studies on the use of SRS to the resection cavity alone, from~     which the 1 year actuarial local control rates range from 35% - 82%. The high rate of~     in-field local failure suggests that the current dosing regimen used may not be high enough~     for adequate local control. Currently, the highest local control rates are approximately 80%,~     but there may be room for improvement with increased dose without significantly increasing~     the risk of side effects.~      The investigators propose a trial for patients after surgical resection of solitary brain~     metastases. The purpose of this trial will be to determine the maximum tolerated dose for~     single fraction SRS to the resection cavity. There will be three groups based on the~     resection cavity size. Dose escalation enrollment will be done sequentially within each~     cohort. You will know which cohort and which specific dose level you are randomized to. After~     treatment, which will take one day, regardless of cohort, you will be followed closely for~     treatment outcome and possible side effects. You will be asked to complete three quick~     surveys at each follow-up appointment regarding quality of life and memory in addition to~     standard of care surveillance brain MRI and physical exam.~   "
165811|NCT01395394|"~     The purpose of this study is to see how tetrahydrobiopterin therapy (BH4; also known as~     sapropterin dihydrochloride or Kuvan) affects measures of oxidative stress and endothelial~     function in patients with Phenylketonuria (PKU).~   "
194980|NCT01011283|"~     The purpose of this study is to compare the response of patients with Intermediate or High~     Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.~   "
165813|NCT01395368|"~     Tinnitus, commonly referred to as ringing in the ears, affects 50 million people in the~     United States and is recognized as a major public health concern. Tinnitus is the most~     frequent cause of service-connected disability claims among war veterans. Tinnitus remains a~     subjectively diagnosed entity. There is no standardized objective method of diagnosing~     tinnitus or describing the functional impact of the condition. Currently, physicians have to~     rely on patient-based self reports. Without an objective method of diagnosing tinnitus and~     describing the functional implications, adequate treatment delivery is also hampered since~     there is no way to objectively stratify patients into severity groups and assess response to~     treatment. Because tinnitus is known to negatively affect cognition through the ventral~     attention networks and the prefrontal cortex, measuring cognitive processing speed is a~     possible way to objectively measure tinnitus. This study builds on previous work the~     investigators have done that utilized a quick, easily accessible measure of auditory~     processing speed. That earlier study showed a correlation between that measure and self~     reported measures of tinnitus severity, and this study attempts determine a more precise~     estimate of that correlation. It also better validates those results by including a~     traditional neurocognitive measuring cognitive speed and by controlling for the presence of~     depression and somatoform disorders.~   "
165814|NCT01395355|"~     This study aims to develop a manualized and culturally sensitive intervention for adolescent~     girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the~     feasibility and acceptability of the intervention in a controlled pilot trial. The~     investigators hypothesize that this intervention will serve to reduce binge and LOC eating,~     as well as improve psychosocial functioning as evidenced by decreased depression, anxiety,~     eating disorder cognitions, and impulsivity, and improved quality of life.~   "
165815|NCT01395342|"~     Introduction:~      Hypertensive disorders during pregnancy are an important issue in global public health. It is~     current the leading cause of maternal mortality in Brazil.~      Objective:~      To assess the effect of physical exercise using stationary bicycle through blood pressure and~     heart rate measurements, incidence of pre-eclampsia and quality of life survey in pregnant~     women with chronic high blood pressure, previous preeclampsia pregnancies or both factors~     associated comparing to a group with no intervention. Verify the type of births, maternal and~     perinatal outcomes in both groups. Methodology: This randomized clinical trial enrolled~     pregnant women presenting chronic hih blood pressure, previous pre-eclampsia experience or~     both. Women from 12 to 20 gestational weeks were selected from the prenatal outpatient clinic~     and randomly allocated to the study or non-interventional group. Women at the study group~     performed physical exercise using stationary bicycle (horizontal bench model) during 20~     minutes, once a week. The heart rate was maintained at 20% above resting heart rate and up to~     140 bpm. Blood pressure and heart rate measurements were evaluated before and after exercise.~     The non-intervention group followed regular prenatal routine with weekly returns for heart~     rate and blood pressure measurements. Both groups fulfilled the quality of life survey (SF-36~     questionnaire) at three times: between 12 and 20 weeks; 28 and 32 weeks and 36 and 41 weeks~     of gestation. After that data of parturition will be analyzed to compare the incidence of~     pre-eclampsia, types of birth, maternal and perinatal outcomes.~   "
165816|NCT01395329|"~     The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone~     in adult humans with elevated blood pressure to a greater extent than either metoprolol or~     placebo.~   "
165817|NCT01395316|"~     The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to~     protect the brain from inflammation and how it may enhance repair through remyelination.~   "
165818|NCT01395303|"~     Polymorphisms in the vitamin D system appear to affect the serum 25(OH)D levels. If so one~     would expect these polymorphisms to be associated with vitamin D related conditions and~     diseases, which will be tested in the present study including DNA analyses in 9700 subjects~   "
165819|NCT01395290|"~     There are indications that the vitamin D status of an individual is related to susceptibility~     to staphylococcal infections. In the present study we will examine nasal colonisation rate in~     subjects participating in an ongoing vitamin D intervention study ( 20.000 IU cholecalciferol~     per week vs placebo) for the prevention of type 2 diabetes in subjects with impaired glucose~     tolerance.~   "
165820|NCT01395277|"~     Groups of naturally occurring compounds called flavonoids are found in foods such as fruits~     and vegetables, red wine, tea, dark chocolate and cocoa products. Diets rich in flavonoids~     are associated with decreased risk for cardiovascular disease and major cardiovascular events~     (i.e. myocardial infarction) and have been shown to improve blood pressure, insulin~     sensitivity, and vascular function in a variety populations (Type II diabetes, elderly,~     smokers, etc.). The presumed beneficial effects of these compounds are thought to act through~     their inherent ability to scavenge free radicals. Specifically flavonoids scavenge superoxide~     anions which are free radicals that react with nitric oxide (NO) to produce peroxynitrite.~     The formation of peroxynitrite ultimately reduces the bioavailability of NO which is~     essential for vasodilation and thus vascular health and function. Normal aging is associated~     with impaired endothelial function, which presumably is due to less than optimal levels of NO~     bioavailability. Therefore, interventions that can increase NO bioavailability would be~     expected to improve microvascular function and vascular health in this population. The~     purpose of this study is to investigate the effects of dietary flavonoid supplementation on~     the vasodilatory capacity of the cutaneous vasculature, as well as on cerebral vascular~     reactivity and arterial stiffness in young and old humans. This study will test the~     hypothesis that acute dietary flavonoid treatment will improve impaired cutaneous~     vasodilatory capacity, cerebral vasomotor reactivity, and reduce arterial stiffness in older~     but not young humans.~   "
165834|NCT01395095|"~     The objective is to investigate whether in acute coronary syndrome patients the cardiac risk~     profile will improve with 2 new extended cardiac rehabilitation interventions and if these~     patients maintain healthier life style habits and a more active life style compared to~     patients randomized to standard cardiac rehabilitation.~   "
165883|NCT01394458|"~     Currently in Canada, either 4% sodium citrate or heparin 1,000-10,000 U/ml solutions are~     locked into hemodialysis catheters between dialysis sessions to prevent thrombosis. The use~     of an ethanol/sodium citrate locking solution may have advantages over either of these agents~     alone. The investigators hypothesize that the 30 % ethanol/4% sodium citrate catheter locking~     solution is safe and effective in the prevention of catheter-related infections and~     thrombosis.~   "
165821|NCT01395264|"~     Migraine is one of the commonest neurological disorders, affecting up to 12% of the general~     population, but remains relatively under-diagnosed and under-treated. Migraine has a wide~     socioeconomic impact and brings a large economic burden; estimates suggest that disability~     due to migraine costs > €27 billion per annum across Europe. Despite its prevalence and~     impact, migraine pathophysiology is poorly understood. A wider understanding of the~     functional changes in this disorder would be beneficial to both diagnosis and treatment.~      Saccades are the rapid eye movements we make when moving the eyes to a new object in our~     visual field. Reaction time studies have been used to investigate Huntington's disease and~     Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements).~     Even at rest we make approximately three saccades per second, so a lot of data can quickly be~     gathered with non-invasive testing. We hope to understand more of the underlying mechanisms~     of migraine by studying reaction time in migraine patients.~      Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at~     fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed~     significantly different saccadic patterns to non-migraineurs.~      This study firstly seeks to corroborate the saccadometric findings of our earlier pilot study~     in a group of migraineurs, and secondly to explore the specificity of these findings in~     migraine by also studying patients with another primary headache syndrome, namely cluster~     headache.~      Migraine is known to be a dynamic disorder, with previous studies showing longitudinal~     changes in the migraine brain. To explore this further we hope to record longitudinally~     (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal~     changes in saccadic reaction time. Because of the portability of the equipment this could be~     done in the subjects own home if they preferred.~   "
165822|NCT01395251|"~     Rheumatoid arthritis is an inflammatory joint disease often leading to progressive joint~     destruction. To prevent disability caused by inflamed joints early diagnosis is important.~     Early diagnosis might be a challenge because the diagnosis is mostly based on clinical signs~     like swelling of small joints. In clinical practice a therapy with prednisolone is started~     although the patients do not have an exact diagnosis. In this cases the prednisolone might~     serve as a diagnostic test for an inflammatory process.~      The objective of this study is to investigate the diagnostic value of oral prednisolone test~     for rheumatoid arthritis.~   "
165823|NCT01395238|"~     This study focuses on the development of the Fathers Supporting Success in Preschoolers~     (FSSP) Program, which combines evidence-based parenting interventions with Dialogic Reading~     to engage fathers in and improve parenting and child behavior.~   "
165824|NCT01395225|"~     When the bladder is removed for bladder cancer, pelvic lymph nodes (LN) are also removed.~     While the anatomic extent of this LN dissection is critical, the investigators often use the~     number of LN removed as a measure of the extent, which in turn is essential for determining~     the patient's further treatment and prognosis. The LN count, however, is also dependent on~     the pathologist's processing of the LN tissue, and the standards for this processing are~     poorly defined. The goal of this study is to establish a standardized method for processing~     and analyzing lymph node specimens. The investigators hypothesize that if an organic solvent~     is used to remove excess fat from the lymph nodes that the investigators will discover more~     clinically significant nodes in a more reproducible fashion when compared to the current~     method.~   "
165825|NCT01395212|"~     The MYSTAR-5-YEAR study controls the patients 5 years after treatment with combined~     (intramyocardial and intracoronary) delivery of autologous BM-MNCs.~      The clinical endpoint of this prospective non-randomized observational study is the MACCE,~     defined as major adverse cardiac and cerebrovascular events. Patients will be investigated by~     echocardiography, SPECT and MRI. 2D (NOGA-guided SPECT) and 3D (NOGA-guided MRI) imaging will~     refine the evaluation with more exact analysis of the intramyocardial injected areas (ROI).~   "
165826|NCT01395199|"~     This study aims to investigate the use of amlodipine, a drug that blocks the uptake of~     calcium into cells, in the prevention and treatment of iron overload in patients with~     thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and~     other organs, blocking these channels might help to prevent the accumulation of iron in these~     tissues. The study will follow 60 patients with thalassemia major: 30 will receive amlodipine~     and 30 will serve as controls receiving placebo in a randomized double-blind fashion.~     Patients will be monitored through one year. Monitoring will occur through the measurement of~     blood ferritin as well as live and heart T2* by MRI initially, at 6 and 12 months.~   "
165827|NCT01395186|"~     there are many studies studying the effectiveness of surgical treatment in patients treated~     for infertility, but only a few reporting the results of varicocelectomy done for pain. This~     study attempted to examine the success rate of varicocele ligation when performed for the~     treatment of pain and to evaluate all the predictor factors that may affect the pain resolve~   "
165828|NCT01395173|"~     The purpose of this study is to determine whether position changes during colonoscope~     withdrawal affects polyp detection rate. We hypothesize that positions change during scope~     withdrawal will increase polyp detection rate.~   "
165829|NCT01395160|"~     The Female Experiences and Brain Activity study will investigate how different groups of~     people process information in different ways. Using electro-physiological methods it will~     investigate differences in brain activity between women with ADHD, women with bipolar~     disorder and those without a psychiatric illness. It will also investigate the relationship~     between patterns of brain activity, mood and functioning.~   "
165830|NCT01395147|"~     The purpose of this study is to assess the safety and efficacy of Lu AA21004 in participants~     with major depressive disorder after completion of an 8-week double-blind treatment period in~     a preceding study (Lu AA21004/CCT-003; NCT01355081).~   "
165831|NCT01395134|"~     Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy~     results in lowered fundamental frequency of the voice and worsened voice performance in~     producing high-frequency sounds. It remains unclear if use of intraoperative nerve monitoring~     (IONM) can improve clinical outcome of thyroidectomy in terms of preserved individual voice~     performance. This study was designed to test that hypothesis.~   "
165832|NCT01395121|"~     The aim of this study is to see if a drug called nilotinib (Tasigna®) is effective in the~     treatment of patients with a rare group of acral and mucosal melanomas that have a change~     (mutation) in a protein called cKIT. Nilotinib interferes with signalling inside cells with~     this mutation and it is believed that this may lead to shrinkage of tumours. Acral melanomas~     are found on the palms and soles and mucosal melanomas start inside body cavities rather than~     on the skin.~   "
165833|NCT01395108|"~     The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in~     healthy Chinese volunteers.~   "
165881|NCT01394484|"~     Does the consumption of dairy foods reduce the rate of bone loss in older women more than~     calcium and vitamin D supplements.~   "
165835|NCT01395082|"~     The purpose of this registry is to study the natural history of vaccination-related~     myocarditis and pericarditis and to assess possible risk factors for these conditions.~      Primary Objective:~      - To document the natural history of confirmed, probable, suspected, and subclinical~     myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.~      Other Pre-defined Objective:~      - To look for potential predictive factors for the prognosis of myopericarditis following~     ACAM2000® vaccination.~   "
165836|NCT01395069|"~     Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing~     macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and~     randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular~     coherence tomography (OCT).~   "
165837|NCT01395056|"~     To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin~     chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced~     killer cells in triple negative metastatic breast cancer patients~   "
165838|NCT01395043|"~     Major abdominal surgery is associated with postoperative pain. Transversus Abdominis~     Plane(TAP) block has been shown to reduce pain and opioid-requirements after abdominal~     surgery. However a single block has a short effect of up to 12 hours depending on the type~     local-anesthetics used.~      With this study we wish to investigate the possibilities to place a TAP-catheter in order to~     prolong the the effect of the TAP-block by giving repeatedly bolus-injections in the TAP~     catheter and to study the pain and the opioid requirements of patients undergoing elective~     colon-resection when given a TAP-catheter preoperatively.~      Our hypothesis is that it is practical and technical possible to place bilateral~     TAP-catheters pre-operatively and that pain and opioid-requirements will be low.~   "
165839|NCT01395030|"~     Altered choline phospholipid metabolism is a recently recognized hallmark of cancer and~     potential diagnostic and therapeutic target in a number of cancers, including hepatocellular~     carcinoma (HCC). The feasibility of detecting HCC on the basis of measuring the~     phosphorylation rate of choline in-vivo has been shown using positron emission~     tomography/computed tomography (PET/CT) and the investigational tracer compound [18F]~     fluorocholine (FCH). This Phase 2 study will evaluate the diagnostic performance of FCH~     PET/CT in patients undergoing surgical resection as treatment for HCC. Since the molecular~     signaling alterations leading to enhanced choline metabolism in tumors are not fully~     elucidated at this time, this study will also collect frozen tissue specimens for~     whole-genome gene expression profiling to elucidate genes and signal transduction pathways~     related to altered choline metabolism in HCC.~   "
165840|NCT01395017|"~     The purpose of this study is to determine whether patients with locally advanced pancreatic~     cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to~     patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.~   "
165841|NCT01395004|"~     The purpose of this study was to assess safety and efficacy at months 3 and 6 in patients~     with Langerhans Cell Histiocytosis given daily oral doses of GSK2110183.~   "
165842|NCT01394991|"~     The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer~     who have chemotherapy-related anemia.~   "
165843|NCT01394978|"~     The purpose of this post approval study is to further characterize the safety profile of the~     ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term~     safety over 90 days of follow-up.~   "
165844|NCT01394965|"~     The purpose of this study is to evaluate a novel non-invasive cardiac electric imaging~     methodology for localizing and imaging cardiac electrical activity from body surface~     electrocardiographic recordings in patients with ventricular tachycardia (VT). Using~     non-invasive means will increase our ability to correctly diagnose cardiac abnormalities, and~     aid ablation of cardiac arrhythmias, offering enhanced performance to what currently exists.~   "
165845|NCT01394952|"~     The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular~     events and other serious outcomes in persons with type 2 diabetes, when added to their~     anti-hyperglycemic regimen.~   "
165846|NCT01394939|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594~     (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in~     colorectal carcinoma patients who are refractory to or intolerant to standard therapy.~   "
165847|NCT01394926|"~     The purpose of this study is to find the optimal dose from 3 different dose levels - 0.15 mL,~     0.5 mL and 1.5 mL of Optison in assessing the presence of disease of the carotid arteries~     when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.~   "
165848|NCT01394913|"~     This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT®~     versus ENBREL®) for treatment of Rheumatoid Arthritis.~   "
165849|NCT01394900|"~     The study has the following primary aims: (1) to test whether participants assigned to CNU (a~     7-session, manualized intervention entitled Connect 'n Unite) engage in lower HIV/STI~     behavioral risk compared to participants assigned to WP (a wellness promotion attention~     control condition); (2) to test whether participants assigned to CNU have lower cumulative~     incidence of STIs—chlamydia and gonorrhea—confirmed via biological assay compared to~     participants assigned to WP; and (3) to test whether participants assigned to CNU engage in~     less drug use compared to participants assigned to WP.~   "
165850|NCT01394887|"~     Hypothesis. To determine the effect of metformin on the concentrations of resistin and other~     insulin resistance or inflammatory markers (C-reactive protein, cytokines, body weight,~     HbA1c, among others) in minors with glucose intolerance.~      Children with glucose intolerance are given either metformin or placebo for 12 consecutive~     weeks.~      High sensitivity C-reactive protein, TNF-alpha, IL-6, IL1-beta, resistin, leptin,~     adiponectin, glucose, insulin, HbA1c, lipid profile and transaminases are measured at the~     beginning and at the end of the period. Statistical analysis: t Student test; Friedman and~     Kruskal Wallis test are used. Variables are adjusted for: sex, age, baseline BMI and~     percentage weight change.~   "
165851|NCT01394874|"~     The purpose of this intervention is to determine whether computer-based telephone counseling~     will improve adherence to strength training in a population of elders with knee~     osteoarthritis.~   "
165852|NCT01394861|"~     The purpose of this study is to evaluate the feasibility, ease and safety of flexible~     endoscopic robotic system to treat early gastric cancer in humans.~   "
165853|NCT01394848|"~     Thanks to rapid reendothelialization derived from the pro-healing property of the EPC capture~     stent, 1-month dual antiplatelet therapy (DAPT) is recommended after EPC capture stent~     implantation. Shorter maintenance of dual antiplatelet therapy might minimize the risk for~     stent thrombosis in cases of discontinuation of antiplatelet regimen and prevent wasteful~     medications and bleeding complications related with dual antiplatelet therapy. Thus, the EPC~     capture stent might be valuable for the elderly because they are vulnerable to premature~     discontinuation of DAPT.~      On the other hand, statin upstream therapy has gained popularity because it seems to reduce~     periprocedural myocardial injury especially in ACS through its pleiotrophic effect like~     plaque stabilization. However, the benefit of pretreatment of statin in patients with stable~     angina remains controversial. It is reported that statin administration could increase EPC~     level by accelerated differentiation towards the endothelial progenitor lineage.~      We hypothesize that the EPC capture stent with 1-month dual antiplatelet therapy is~     non-inferior to DES in the elderly subjects with stable coronary artery disease. To test this~     hypothesis, we will perform a multi-center, randomized, prospective trial aimed at~     demonstrating the efficacy and safety of the EPC capture stent with 1-month DATP versus EES~     with standard 12-month DAPT in elderly patients with stable coronary occlusive disease in~     real world practice.~   "
165854|NCT01394835|"~     Bronchiolitis obliterable syndrome (BOS) is the most common cause of death in long-term~     survivors after lung transplantation and refractory to most interventions. Many risk factor~     for BOS were identified in previous studies such as acute cellular rejection, lymphocytic~     bronchiolitis, cytomegalovirus (CMV) and non-CMV respiratory infections, injury to the~     allograft or airways, Primary graft dysfunction, HLA mismatching, and organizing pneumonia.~     (Belperio JA. et al.). Neutrophils and their released products may be involved in the~     development of BOS. Neutrophilia was repeatedly observed in the bronchoalveolar lavage fluid~     of patients after lung transplantation. In addition, infiltration of neutrophils into the~     bronchial epithelium has been detected in patients with higher degrees of active airway~     damage. Neutrophils are capable of causing severe damage to the lung tissue by releasing~     toxic proteases and reactive oxygen species if not counterbalanced by the antiprotease/~     antioxidant screen of the lung. Based on this background, a causal relationship between~     neutrophilia and the development of BOS has been proposed. (Hirsch J. et al.) Detection of~     unopposed Neutrophile elastase (NE) activity in BAL appears to correlate with poor outcome~     due to refractory BOS. Unopposed NE in these subjects may not only serve as a marker of~     evolving graft dysfunction but also participate in damaging the airways of the allograft and~     inhibit adequate bacterial clearance. Prevention of neutrophil sequestration or inhibition of~     NE may prevent or attenuate airway damage and improve bacterial clearance mechanisms. (Nutley~     D et al.) These data demonstrate the importance of neutrophils and unopposed NE in the~     pathogenesis of BOS and call for new approach to prevent or modulate BOS targeting this~     mechanism.~      AAT is the main inhibitor of neutrophil elastase in the lower airways and patients with AAT~     deficiency have low concentrations of the protein in this region of the lung. This explains~     the proteinase/antiproteinase theory of the development of emphysema in deficient patients in~     which the amount of elastase released in the lung exceeds the amount of AAT. The net result~     is persistence of elastase activity leading to lung destruction and the pathological changes~     of emphysema. (Abusriwil H. et al.) The administration of the AAT is to address~     proteinase/antiproteinase imbalance.~      Administration of AAT will help to prevent further destruction of the lung architecture and~     reduce the inflammatory dysregulation that causes pulmonary dysfunction. It is expected that~     by attacking a specific and previously untreated key component part of the pathophysiological~     cycle of BOS, AAT therapy would decrease the prevalence of BOS in lung transplant recipients~     and prolong life expectancy of these patients.~   "
165855|NCT01394822|"~     The purpose of this study is to determine if a new diagnostic technique, called neuromuscular~     ultrasound, can improve our ability to diagnose focal nerve disease.~   "
165856|NCT01394809|"~     The therapy results after distal radius fracture especially of elderly patients are often~     suboptimal. The central problem results from the inevitable, 3-6-weeks immobilization, which~     leads to reduction in ROM of the wrist, deterioration of muscle strength as well as~     malfunction of fine motor skills and coordination. Currently, there are no adequate proactive~     strategies to counteract these immobilisation problems. Hence the overall aim of our research~     project is to investigate the therapeutic potential of a motor-cognitive therapy on hand~     function after distal radius fracture. On the one hand the pilot study should provide~     information about the level of recruitment rate necessitated for an adequate sample size~     which allows reliable evidence for the therapy effects. On the other hand we want to evaluate~     the sensitivity and adequacy of the assessment instruments.~      The pilot is conceived as a controlled, randomised, longitudinal intervention study over 6~     weeks with 3 groups. One experimental group imagine movements and actions without executing~     them. A second experimental group performs mirror training, in which visual feedback through~     a mirror activates additionally the contralateral hemisphere. The control group receives~     therapy as usual. There are three key domains to be analysed: function (PRWE), impairment~     (ROM, strength) and participation in social life/life quality (DASH, EQ5D).~   "
165857|NCT01394796|"~     There is a mounting evidence of the modulation properties of the major catechin in green tea,~     epigallocatechin-3-gallate (EGCG), on dual specificity tyrosine-phosphorylation-regulated~     kinase 1A (DYRK1A) gene overexpression in the brains of DS mouse models.The aims are to~     investigate the clinical benefits and safety of EGCG administration in young adults with DS,~     to establish short-term EGCG effects (three months) on neurocognitive performance, and to~     determine the persistency or reversibility of EGCG related effects after three months of~     discontinued use.~   "
165858|NCT01394783|"~     Every year thousands of neonates born in North America need extensive resuscitation which~     often includes endotracheal intubation (ETI). In these situations, Pediatricians assume the~     role of Neonatal Resuscitation Program (NRP) providers and are responsible of the ETI~     procedure. They acquire this skill during residency training in the Neonatal Intensive Care~     Unit (NICU) and the delivery room. Difficulties in performing neonatal ETI lie in the small~     size of the mouth and airway of the neonate, and their particular anatomy of the larynx. This~     limited visibility represents a challenge even for the experienced clinician. Recently, a new~     videolaryngoscope (VL) technique has been introduced to the adult and pediatric medical~     fields as described respectively by Kaplan et al. and Weiss et al. In 2009, Vanderhal et al.~     reported a preliminary experience in the newborn population. Video assisted intubation could~     be a method of choice in teaching neonatal ETI.~      To the best of our knowledge, there is no human study comparing the VL to the classic~     laryngoscope (CL) for acquiring the skill of neonatal ETI in the NICU.~      This study aims:~        1. To assess if the videolaryngoscope is superior to the classic laryngoscope in acquiring~          the neonatal endotracheal intubation skill in the Neonatal Intensive Care Unit; and~        2. To assess if once the skill is acquired with the videolaryngoscope this experience is~          transferable to the use of the classic laryngoscope by showing a persistent difference~          in success rate in favor of the videolaryngoscope group.~      The hypothesis are~        1. Primary hypothesis:~           In the Neonatal Intensive Care Unit, use of the videolaryngoscope will increase success~          rate of endotracheal intubation by 20% compared to the classic laryngoscope. Later,~          acquired experience from the videolaryngoscope will be transferable to the use of the~          classic laryngoscope by showing a persistent difference in success rate of 20% in favor~          of the videolaryngoscope group.~        2. Secondary hypothesis We expect that the videolaryngoscope will decrease time to~          intubation, and decrease rate of esophageal and right bronchial main stem intubations.~          It will also improve teaching of endotracheal intubations to pediatric residents by~          helping supervisors recognize problems related to intubation and by improving residents'~          level of confidence in performing the skill.~   "
165859|NCT01394770|"~     Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study~     was undertaken to ascertain whether aliskiren, a direct renin inhibitor, compared with~     amlodipine, a calcium channel blocker, reduces mortality and cardiovascular events in these~     high-risk patients.~   "
165884|NCT01394445|"~     The investigators hypothesize that the administration of physostigmine in the postoperative~     period after nephrectomy reduces opioid consumption.~   "
165860|NCT01394757|"~     Alterations of functional brain networks have been frequently demonstrated in schizophrenia,~     although the exact underlying molecular mechanisms remain unrevealed. Ketamine is known to~     exert its schizophrenia-like effects through modulation of the glutamatergic system, thus~     facilitating the investigation of the impact of this specific transmitter system on resting~     state functional brain networks. The aim of the study is therefore to use pharmacological~     functional Magnetic Resonance Imaging (phMRI) to examine changes in brain networks involved~     in schizophrenia in response to ketamine application compared to placebo. 30 healthy subjects~     (15 females) will be examined twice using a double-blind, placebo-controlled, randomized,~     crossover, counterbalanced-order design. Resting state fMRI will be investigated before,~     during and after either placebo or ketamine intravenous infusion for 20 minutes. Prior to the~     main trial 10 additional participants will be included in an open pilot trial.~      Hypothesis: Ketamine application will induce changes in resting state networks previously~     associated with schizophrenia and in the connectivity of relevant brain regions such as the~     striatum, thalamus, caudate, hippocampus and amygdala. Furthermore, the application of~     ketamine will provoke changes in the BOLD-activation in three fMRI paradigms each performed~     before and after ketamine infusion.~   "
165861|NCT01394744|"~     The goal of the study is the analysis of metal ion serum concentrations and of the cytokine~     production in the blood of patients with a conventional cementless total hip replacement. The~     rationale is that a) the bearing wear releases particles respectively metal ions into the~     joint and the blood which will differ in quantity and composition; b) the cytokine production~     of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the~     metal and the ceramic particles.~      The patients from whom the respective samples will be analyzed are randomized in one of the~     following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm~     bearing is used in all patients. In this separate study, follow-up data of the clinical and~     radiographic examinations of the patients are available.~   "
165862|NCT01394731|"~     The purpose of this study is to determine whether intravenous paracetamol is effective in~     treating labor pain.~   "
165863|NCT01394718|"~     This is a prospective, randomized, double-blinded, placebo controlled trial Potential~     subjects will be identified from the Pre-Surgical Anesthesia Clinic visit. Parents/legal~     guardians will be approached about study participation at the Anesthesia outpatient~     pre-visit. Attending Anesthesiologist will receive e-mail notification about potential~     subject participation the day before the scheduled surgery. Study lab (hepatic function~     panel) will be collected as soon as possible after anesthesia induction by anesthesia.~     Results will be reviewed by study team member and study drug will be ordered by study team if~     patient does not meet exclusion criteria. Study drug (IV acetaminophen or placebo) will be~     administered at the time of skin closure by anesthesia on completion of the surgical~     procedure (after randomization). Study drug will be administered every 6 hours for 2 days.~     Subjects will continue to receive standard of care with patient controlled analgesia (PCA)~     opiate therapy (morphine or hydromorphone) for analgesia as per the Pain Management Service.~     Pain scores, opiate (morphine equivalent) administered, requirements for treatment of opiate~     related side effects (treatment for nausea and itching), and certain post-operative~     characteristics will be measured for up to 4 days post-operatively (time to mobilization,~     time to diet advancement, time to discharge).~   "
165864|NCT01394705|"~     This pilot study seeks to compare the change in energy expenditure and fitness levels of~     patients seen in the Children's Hospital Preventive Cardiology program receiving standard of~     care provider exercise counseling to similar patients receiving Frequency, Intensity, Time,~     Type (FITT) exercise prescription and counseling combined with BodyMedia supported by an~     online interactive tool.~      The investigators primary hypothesis is that this interactive technology coupled with support~     from a exercise specialist will increase the energy expenditure of the investigators patients~     over standard of care provider counseling.~      The investigators Secondary hypotheses include greater improvement in measured physical~     fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold~     (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure, arterial~     stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the intervention group~     compared to control.~   "
165865|NCT01394692|"~     Excision to the maximum possible extent marks the first step of glioma surgery. Depending on~     tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre~     studies have shown that the presence of residual tumour according to MRI-criteria is a~     prognostic factor in this incurable condition.~      In order to improve the extent of resection, several methods, in particular intraoperative~     imaging techniques, have become available to demonstrate already during surgery whether the~     goal of surgery has been achieved. The intraoperative MRI devices currently available differ~     in their magnetic field strengths and image resolution, but also in their amount of~     interference with the surgical workflow.~      Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma~     surgery are lacking. To assess whether the rate of radiologically complete tumour resections~     can be improved by using intraoperative MRI-guidance, we designed this prospective,~     randomized trial. We hypothesized that the extent of resection that can be achieved using an~     intraoperative MRI is greater than that of conventional microsurgical tumor resection.~   "
165866|NCT01394679|"~     The purpose of this study is to determine if the images of the primary lesions of lung cancer~     and any metastatic lesions seen from the investigational SPECT/CT 99mTC-EC-DG scans are the~     same as the PET/CT 18F-FDG scans.~   "
165867|NCT01394666|"~     The purpose of this study is to evaluate treatment patterns and associated outcomes for~     CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.~   "
165868|NCT01394653|"~     A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating~     tablet with those of conventional tablet. Tablets will be administered with water.~   "
165882|NCT01394471|"~     Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves~     social cognition, psychotic symptoms and social functioning in schizophrenia.~      Participants: 80 adults with schizophrenia or schizoaffective disorder for at least one year.~      Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal~     spray for 12 weeks. Before, during and at the end of the trial, each subject will undergo~     psychiatric symptom ratings and tests of mental abilities used in social functioning,~     cognition, and social competence.~   "
165869|NCT01394640|"~     Primary objective~      1) To assess whether oncologic and hematologic patients develop a protective immunological~     response after pandemic Influenza A (H1N1) vaccine~      Secondary objectives~        1. To compare the levels of antibody response against A (H1N1) influenza virus between~          oncologic and hematologic patients relative to a cohort of healthy volunteers~        2. To assess the incidence of A (H1N1) infection in vaccinated oncologic and hematologic~          patients in comparison with a cohort of vaccinated healthy volunteers. To assess the~          clinical symptoms attributable to influenza infection in vaccinated oncologic and~          hematological patients and healthy volunteers.~        3. To compare the levels of antibody response against A (H1N1) influenza virus between the~          following subgroups: patients with ongoing chemotherapy; patients who have completed the~          chemotherapy treatment; patients treated with autologous or allogeneic peripheral blood~          hematopoietic stem cell transplant (PBSCT)~      Study procedures: Onco-hematological patients will perform a blood sample collection before~     the vaccination, on day +21 after vaccination , on day +50 and on day +90. At the end of the~     collection, the investigators will perform immunological test to evaluate the antibody titer~     and the cellular response. The titer of antibodies against the vaccine strain will be~     measured in all samples by hemagglutination-inhibition (HI) assays with the use of turkey~     erythrocytes and according to EMEA guidelines. Response criteria will be the achievement of a~     protective title of HI test > 1:40. In addition, the investigators will evaluate: geometric~     mean titers and a fourfold titer increase compared with prevaccination titers.~     Cellular-mediated response will be analysed by flow-cytometry. A control cohort of healthy~     volunteers who received A(H1N1) vaccine will perform the same blood sample collection.~      Evaluation of clinical response: Oncologic and hematologic patients will be followed as~     outpatients or inpatients according to routine controls for their disease. In case that~     symptoms of the upper airways or influenza-like symptoms develop, the symptoms will be~     recorded in the clinical database, nasal and pharyngeal swaps will be performed according to~     the doctor who is taking care of the patient. In order to evaluate the clinical efficacy of~     the vaccination, the swaps will be tested for A (H1N1) influenza virus infection. No further~     studies will be performed after 3 months from the vaccination.~   "
165870|NCT01394627|"~     The purpose of this study is to look at whether blockade of the mineralocorticoid receptor~     will result in changes in the cardiovascular and inflammatory response to hypoglycemia.~   "
165871|NCT01394614|"~     The goal of the study is to assess the risk of occurrence of narcolepsy following the~     administration of inactivated (AS03) adjuvanted A/H1N1 pandemic influenza vaccine in the~     province of Quebec, Canada, using different case definitions and time intervals to disease~     onset, while controlling for potential confounding variables such as age, gender, season and,~     when possible, A/H1N1 pandemic influenza infection. Another aim is to describe the~     epidemiology and clinical features of narcolepsy cases with onset during the period January~     1st, 2009 to December 31, 2010 in the population of Quebec.~   "
165872|NCT01394601|"~     RECONNECT-S ALPHA is a multicentre study to observe the management of schizophrenic patients~     who are hospitalized due to an acutely agitated psychotic episode. The patients should be~     managed according to normal clinical practice until discharge time. Data will be collected by~     review of medical records of the hospitalisation prior the study visit. During the study the~     patients will conduct one visit on the day of their discharge after hospitalisation due to an~     acutely agitated psychotic episode. On the study visit data on demographics, diagnosis and~     medical history will be recorded. Data on antipsychotic and concomitant medication will be~     collected by review of medical records.~   "
165873|NCT01394588|"~     This is an observational study of continuous glucose monitoring technology during cardiac~     surgery. The investigators would like to develop data for descriptive analysis of a~     comparison of continuous glucose monitoring with a gold standard under the conditions of~     cardiac surgery.~   "
165874|NCT01394575|"~     This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma~     in situ treated by breast conserving surgery, postoperative whole breast irradiation with~     inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically~     feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic outcome and~     local control rate in a single center~   "
165875|NCT01394562|"~     The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves~     exercise capacity, physical functioning and quality of life in patients with iron deficiency~     and chronic heart failure.~   "
165876|NCT01394549|"~     Despite efforts of learned societies, community cardiology and more generally of most players~     in the health, cardiovascular diseases continue to be the leading cause of death among women~     in France and all over the Western world, there where they fell to second place among men.~     Clinical practice and the disparity between the sexes are still insufficiently known.~      Multicenter observational study on a cross-week comparative basis with men~   "
165877|NCT01394536|"~     Postoperative nausea and vomiting after outpatient surgery are significant sources of patient~     dissatisfaction. The prevention of postoperative nausea and vomiting (PONV) should be equally~     as important as prevention of pain because both are large sources of patient dissatisfaction~     and can necessitate admission after routine outpatient procedures.~      None of the currently available pharmacological interventions are able to totally abolish~     PONV. The use of electroacustimulation is a useful adjunct in prevention of PONV, but has yet~     to be studied when the patient takes the device home with them after leaving an outpatient~     facility.~   "
165878|NCT01394523|"~     The literature has clearly demonstrated that the effective treatment of postoperative pain in~     infants and children is challenging. In an effort to improve postoperative analgesia while~     limiting opioid-related adverse effects, there continues to be an increased use of regional~     anesthetic techniques in infants and children. Although the pediatric caudal remains the most~     commonly used pediatric regional anesthetic technique, it has been demonstrated that~     effective analgesia can be provided with the use of peripheral nerve blockade even in the~     pediatric-aged patient. The purpose of this study is to prospectively compare post-operative~     pain relief in pediatric patients undergoing umbilical hernia repair who have received either~     a caudal block or bilateral rectus sheath blocks for analgesia~   "
165879|NCT01394510|"~     Insulin is secreted by cells in the pancreas called beta-cells. Beta-cell dysfunction is a~     critical feature of type 2 diabetes (T2DM). High glucose levels can exacerbate beta-cell~     dysfunction with oxidative stress proposed as a major mediator of this glucotoxic effect.~     High glucose levels have also been shown to contribute to vascular dysfunction and~     inflammation and these adverse responses decreased with the use of antioxidants. The~     hypothesis is that antioxidants improve beta-cell function in individuals with elevated~     glucose levels by decreasing oxidative stress. In this study the investigators will~     specifically test whether the antioxidant N-acetylcysteine (NAC) can improve beta-cell~     function in individuals with type 2 diabetes by decreasing oxidative stress.~      This study will be a dose finding study to determine the tolerability of 600 mg versus 1200~     mg twice a day of NAC and the effects on beta-cell function, glucose tolerance and oxidative~     stress markers in persons with type 2 diabetes.~   "
165880|NCT01394497|"~     Randomized prospective study on the impact on the post-LT outcome by the infusion of~     N-acetylcysteine (NAC) during the liver procurement procedure, as an anti-oxidant agent to~     reduce the ischemia-reperfusion damage of organs for liver transplantation (LT).~   "
165889|NCT01394380|"~     The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can~     soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks,~     subjects will be randomized to either a 12-week intervention arm in which sweetened beverages~     will be replaced by artificially sweetened, calorie-free beverages, or to a control arm. The~     following measurements will be performed at the end of the run-in period and at the end of~     the intervention period~        -  intrahepatic fat concentration~        -  visceral fat volume~        -  changes in day-long metabolic profile from baseline(plasma glucose, insulin, and~          triglyceride concentrations)~        -  changes in food intake and daily energy, carbohydrate and sugars intake from baseline~   "
165890|NCT01394367|"~     Aim of this study is to investigate whether and to what extent a cautious respiratory and~     exercise therapy can complement medical treatment and change the condition, oxygen uptake,~     quality of life, the pulmonary vascular pressures, the size of the right heart and the~     6-minute walk distance in patients with pulmonary hypertension.~   "
165891|NCT01394354|"~     Primary objective of the study is the determination of the maximum tolerated dose (MTD) of~     Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and~     Dexamethasone (D).~      Secondary objectives are:~      Assessment of safety and tolerability of VBDD; efficacy data of VBDD.~   "
165892|NCT01394341|"~     Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is~     new and fundamentally different from the classical treatments with oral antidiabetic agents~     and insulin. The novel and original aspect of this investigator-initiated study is the focus~     on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients~     with severely reduced kidney function. At present there is virtually no knowledge of the~     physiology and clinical implications of the role of incretin hormones and incretin-based~     therapy in this group of diabetic patients.The aim of the study is to establish an~     evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of~     antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall~     hypothesis is that patients with T2D and severe renal insufficiency will tolerate and benefit~     from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic control and~     reducing risk factors of cardiovascular disease~   "
165893|NCT01394328|"~     The aims of this study were to identify risk factors associated with delirium in hospitalized~     persons with dementia, and to describe immediate and post-hospital (1&3 months) trajectory of~     cognitive decline and associated outcomes in persons with dementia who develop delirium. It~     was hypothesized that factors such as CNS-active medications, urinary tract infection, stage~     of dementia, pain, activity level, and dehydration would be associated with an increased risk~     of delirium and delirium severity in patients with dementia compared to dementia patients~     without delirium. It was also hypothesized that persons with DSD will have worse outcomes~     (longer hospital length of stays, decreased functional status, a steeper negative slope of~     cognitive decline) than dementia patients without delirium. Lastly, it was hypothesized that~     higher delirium severity would be associated with poorer outcomes in persons with dementia.~     The long-term objectives were to use the results from this study to design and test an~     intervention strategy to improve early recognition, management, prevention, and outcomes in~     persons with DSD.~   "
165894|NCT01394315|"~     The aim of the study is to determine if DOT can detect response early in breast cancer~     patients undergoing neoadjuvant chemotherapy.~   "
165895|NCT01394302|"~     The purpose of this study is to Characterize the population of people who suffer from trigger~     finger (TF) in terms of demographic (Gender, age, occupation, etc.); motor skills (hand~     function); the Consequences of the disease on a person's daily functioning and impact on~     quality of life.~      The study will also attempt to examine the suitability of several common assessment tool for~     evaluation of hand rehabilitation Patients who suffer from TF.~      Information obtained from the study will enable a deeper comprehension of the consequences of~     TF on the patient and will be the first step in developing a protocol assessment and~     evidence-based treatment in this population.~   "
165896|NCT01394289|"~     The objective of this study is to determine the biologic activity of a Lolium perenne~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
165897|NCT01394276|"~     This observational study will evaluate the efficacy and safety of RoActemra/Actemra~     (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis.~     Data will be collected from patients for the 12 months following the first infusion of~     RoActemra/Actemra.~   "
165898|NCT01394263|"~     This trial was an open-label, multi-national, randomized, parallel treatment, active-control~     multicenter study in adult males with documented metastatic prostate cancer disease who were~     judged to be candidates for hormone therapy.~   "
165899|NCT01394250|"~     The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable~     device that provides cold and vibration, in reducing the pain associated with intravenous~     (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical~     lidocaine cream in reducing the pain associated with IV cannulation.~   "
165900|NCT01394237|"~     The purpose of this study is to determine the long term results of laparoscopic~     sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries~     required, patients satisfaction and quality of life.~   "
165901|NCT01394224|"~     The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the~     bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg~     and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.~   "
165902|NCT01394211|"~     This phase II trial studies how well giving pazopanib hydrochloride and anastrozole before~     surgery works in treating patients with stage II-III estrogen receptor-positive breast~     cancer. Pazopanib hydrochloride and anastrozole may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving pazopanib hydrochloride and~     anastrozole together before surgery may make the tumor smaller and reduce the amount of~     normal cells that have to be removed~   "
165903|NCT01394198|"~     The purpose of this study is to correlate the link between palpatory findings of somatic~     dysfunction and gastrointestinal endoscopic evidence of changes in mucosa. The investigators'~     hypothesis is that there is a direct connection between somatic palpatory changes and~     intestinal mucosal changes via a somatovisceral/viscerosomatic mechanism.~   "
165904|NCT01394185|"~     Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days~     in a randomized order. During each dronabinol maintenance period they were able to~     self-administer active or placebo cannabis using either a progressive ratio schedule or~     choice between cannabis and monetary alternative.~   "
165905|NCT01394172|"~     The purpose of this study is to quantify the tidal volume generated by the pressure release~     immediately following the application of pressure to the chest.~   "
165906|NCT01394159|"~     The aim of this research study is to identify the best needle for performing biopsy during~     EUS procedures. There are two types of needles for performing biopsy: A FNA needle that~     provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger~     amount of tissue. It is not clear at this point which of the two needles is superior for~     performing biopsy. This study will attempt to identify the better needle by assessing the~     performance of both needles in a randomized fashion.~   "
165907|NCT01394146|"~     The purpose of the study is to learn more about how phosphorus-based food additives affect~     phosphorus metabolism in people with normal kidney function.~   "
165908|NCT01394133|"~     Data suggests that women taking drugs to treat human immunodeficiency virus (HIV) have higher~     amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The~     reason for this higher drug exposure has not yet been determined. The primary purpose of this~     study is to examine whether a pharmacokinetics (factors that determine the amount of drug in~     the body) of anti-HIV drugs change during different phases of the menstrual cycle in women~     and ultimately result in higher amounts of drug in the body compared with men. In other~     words, we plan to examine whether changes in sex hormones throughout the menstrual cycle~     affect the amount of anti-HIV drugs in HIV infected women. The antiretroviral drugs~     atazanavir, ritonavir, tenofovir and emtricitabine will be studied.~   "
165909|NCT01394120|"~     In recent years, treatment of advanced pancreatic cancer is changing. Currently, there are~     several active schedules of chemotherapy that can be used, such as gemcitabine as monotherapy~     or in combination with capecitabine or erlotinib, and FOLFIRINOX. Moreover, the development~     of biomarker (therapeutic targets) that can predicte response to treatment is a new important~     tool to be used in clinical practice to select the best scheme for each patient. Preliminary~     studies showed that therapeutic target determination, using tumor tissue collected from~     patients, could determine the presence of groups of chemotherapy responders. Such is the~     case of EGFR amplification and/or K-Ras gene status and correlation with response to~     erlotinib. Moreover, Thymidilate Synthase, Thimidine Phosphorylase, ERCC-1 and Topoisomerase~     I expression by immunohistochemistry in GI tumor samples has been related to resistance or~     response to 5FU-capecitabine, oxaliplatin and irinotecan respectively. Based on this data the~     investigators designed a phase II clinical trial to evaluate the efficacy of selected~     treatment for pancreatic cancer patients based on the determination of therapeutic targets.~     The therapeutic target-driven treatment efficacy will be compared to the prospective~     treatment of a control group of patients treated at the discretion of the~     physician-researcher~   "
165910|NCT01394107|"~     The project aims to clarify the effect of the thromboprophylactic LMWH dose on coagulation in~     pregnant women just before birth, at the period of maximal physiological hypercoagulable~     state and with high risk of thromboembolism, the most common cause of maternal mortality in~     developed countries. Although LMWH are now routinely administered as prevention of~     thromboembolism, their effect on coagulation in pregnant women was not yet studied. The doses~     of LMWH in pregnancy are only derived in terms of coagulation from totally different groups~     of patients (surgical, orthopedic). We therefore will map the effect of thromboprophylactic~     LMWH dose on coagulation in pregnant women using recently available methods, especially a~     complex examination of coagulation within 24 h after LMWH application using~     thrombelastography, including examination with heparinase, and monitoring the effect of LMWH~     by measuring antiXa and TGT (thrombin generation time) activity. Based on these results we~     will also evaluate the possible influence of LMWH prophylaxis on the risk of spinal haematoma~     during neuraxial analgesia/anesthesia for delivery/Caesarean section. On the basis of our~     pilot results we can presume the current dosage of LMWH in pregnant women is inadequate and~     that it would be appropriate to adjust presently used dosage. At the same time we want to~     prove that the standard LMWH thromboprophylaxis in pregnant women does not increase the risk~     of spinal haematoma during neuraxial blockade. In both situations the targeted outcome is to~     increase the safety of pregnant women.~   "
165911|NCT01394094|"~     Gum chewing can promotes the return bowel function after gynecologic surgery.~   "
165912|NCT01394081|"~     The purpose of the Alabama Veterans Rural Health Initiative is to better understand access~     and barriers to health care and to enhance veteran enrollment or engagement in health care~     services of veterans residing in rural areas. It describes an intervention that is adaptable~     for use by other VA facilities that serve veterans in rural settings, and importantly, this~     study will improve our understanding of barriers to care and evaluate a method for enhancing~     access to care. The anticipated impact is that more veterans in rural areas who were~     previously under-utilizing VA services will receive and attend a health care appointment.~     This gain may improve preventative and primary care health care and reduce long term health~     care morbidity, expense and burden. This study may also identify previously unknown barriers~     to care that can be surmounted by innovative access and health care delivery approaches.~      The primary objective is to evaluate an innovative approach for enhanced enrollment and~     engagement outreach intervention (EEE intervention) for rural veterans in VA health care~     services. This study entails a two-cell design, addressing this objective with a prospective,~     randomized controlled multi-site clinical trial that evaluates an active intervention~     compared to administrative outreach (AO, control condition) on whether or not a~     rurally-residing veteran obtains and attends a VA appointment.~   "
165925|NCT01393912|"~     This is a Phase I clinical trial evaluating crenolanib (CP-868,596), an inhibitor of Platelet~     Derived Growth Factor Receptor (PDGFR)-kinase in children and young adults with newly~     diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) or in recurrent, progressive or~     refractory High Grade Glioma (HGG) including DIPG (Stratum B). This study drug targets the~     most commonly amplified region of genome found in DIPG and pediatric high grade glioma (HGG)~     which encodes for the PDGF receptor kinase. An oral investigational agent crenolanib will be~     administered daily during and after local radiation therapy (RT) in Diffuse Intrinsic Pontine~     Glioma DIPG (Stratum A), or daily for children with recurrent/refractory HGG (Stratum B).~   "
165913|NCT01394068|"~     In this observational study the effect of selenium supplementation on the postoperative~     inflammatory response and clinical course should be examined in (approximately 100) adult~     patients undergoing elective heart surgery combined with extracorporeal circulation.~      Selenium is one of the essential trace elements with a variety of important immunological and~     antioxidant properties. The pathophysiological relevance of different selenium-dependent~     reactions has already been demonstrated in human and in animal experiments. It is essential~     for the enzymatic functions of selenium-containing proteins such as the glutathione~     peroxidase, which in turn affects the leukotriene, thromboxane and prostacyclin metabolism.~     In addition, selenium has a significant influence on various liver enzymes, therefore~     selenium deficiency leads to oxidative or chemically induced liver damage.~   "
165914|NCT01394055|"~     The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK)~     profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and~     delayed gastric emptying.~   "
165915|NCT01394042|"~     This is a small study to determine if probe, similar to an ultrasound probe, can detect~     prostate cancer more specifically than other imaging studies in patients with a positive~     prostate cancer biopsy.~   "
165916|NCT01394029|"~     This study will observe patients with transfusional hemosiderosis treated with deferasirox in~     actual practice setting.~   "
165917|NCT01394016|"~     The purpose of this study is to determine a safe dose of LY2835219 to be given to~     participants with advanced cancer and to determine any side effects that may be associated~     with LY2835219 in this population. Efficacy measures will be used to assess the activity of~     LY2835219 in this population.~   "
165918|NCT01394003|"~     The main purpose of this trial is to determine a recommended Phase 2 dose of LY2584702 that~     may be safely administered to patients with advanced/metastatic cancer.~   "
165919|NCT01393990|"~     The objective of this study is to determine a safe dose of LY2228820 that may be given to~     patients with advanced cancer. Part A of this study will consist of dose escalation, and Part~     B will consist of dose confirmation.~   "
165920|NCT01393977|"~     The morbidity of spinal cord injury (SCI) is increasing significantly in China. The methods~     to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation~     therapy is the routine method to treat SCI in sequela stage, its effect to improve the~     neurological disorders of these patients, such as the dysfunction of sense, motor, autologous~     adjustment of blood pressure control of urination and defecation, perspiration , etc. is~     unsatisfying. Rehabilitation Therapy can prevent the process of muscle atrophy and joint~     stiffness. However, it can not repair the damaged nerve function. Studies show that~     mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI~     in animals without any severe side effect.~      In this study, the investigators use mesenchymal stem cells derived from umbilical cord to~     treat 40 SCI patients (20 cases in early stage and 20 cases in sequela stage). The~     investigators also follow-up ten patients who only receive rehabilitation and another ten~     outpatients who accept neither stem cell therapy nor rehabilitation. On this basis, the~     investigators can compare the efficacy of these two treatments.~   "
165921|NCT01393964|"~     The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients~     with very low kidney function including patients on dialysis.~   "
165922|NCT01393951|"~     This trial is designed as a blinded, randomized and parallel group study to investigate the~     clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and~     safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in~     healthy adults.~   "
165923|NCT01393938|"~     Mullerian duct anomalies (MDAs) are relatively common disorders, with a prevalence estimated~     to be around 2% in the general population, and 6% to 7% in women with a history of recurrent~     pregnancy loss. Mullerian duct anomalies are associated with recurrent pregnancy loss, intra~     uterine growth retardation, and preterm labor and birth. The prevalence of preterm birth and~     pregnancy loss varies with the type of MDA. Patients can benefit from surgery or~     hysteroscopic interventions like metroplasty based on the type of MDA. Therefore, to optimize~     patient outcomes, accurate diagnosis and description of MDAs is essential.~      Magnetic resonance imaging (MRI) is an excellent way of evaluating the uterus for MDAs. MRI,~     although costly, is less expensive than laparoscopy and hysteroscopy and is non-invasive.~     Pellerito et all evaluated 26 women with surgically proven MDAs and found that in 24 cases~     MRI was able to correctly diagnose the MDAs. Therefore MRI is generally considered as a~     reference standard for uterine evaluation. In a study comparing MRI and endovaginal~     Two-Dimensional Ultrasound (2DUS), MRI appeared to be more accurate than 2DUS with a~     sensitivity of 77%, specificity of 33%, and a positive predictive value of 83%.~      Endovaginal Three-Dimensional Ultrasound (3DUS) is a relatively new technology that creates~     three-dimensional volumes from a series of two-dimensional images. This technique allows the~     user to acquire coronal or face-on-view of the uterus which is essential in evaluating the~     uterus for the presence of MDAs. Kupesic and Kurjak used 3DUS to evaluate 86 patients and~     found that it had sensitivity of 98.38%, specificity of 100%, a positive predictive value of~     100%, and a negative predictive value of 96% in the diagnosis of septate uteri [7].~     Endovaginal 3DUS is less expensive, less invasive, and less-time consuming than hysteroscopy~     or MRI and appears to be a very promising technology for the evaluation of MDAs. 3DUS appears~     to be at least as accurate as MRI in the diagnosis of MDAs. In addition, 3DUS is less~     expensive than MRI and in some patients better tolerated. If validated using prospective~     studies, 3DUS has the potential to become the reference standard for the diagnosis of MDAs.~   "
165924|NCT01393925|"~     This prospective, double blind, placebo-controlled, parallel group study will be conducted in~     the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged~     18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia~     will be involved in this study. According to previous studies and our pilot trial, the sample~     size was estimated to be 120 subjects. All eligible patients will be randomly assigned to one~     of three groups: Group A (single parecoxib) receiving parecoxib 40mg at 30min before the end~     of surgery; Group B (multiple parecoxib) receiving parecoxib 40mg at 30min before the end of~     surgery, at 8h and 20h after the surgery, respectively, and Group C (Control group) receiving~     normal saline. All patients will be managed by a standard propofol-remifentanil based total~     intravenous anesthesia protocol. The incidence and intensity of shoulder pain at rest and~     with motion will be evaluated by an independent doctor blinding to medication and grouping~     using visual analog scale (VAS) at 6h, 24h and 48h postoperatively. Other types of pain (e.g.~     trocar wound and visceral pain), side effects (such as postoperative nausea and vomiting,~     itching, dizziness, and oversedation) will be assessed as well. At the end of the~     observation, the intensity of the maximum pain will be recorded, and the effect of shoulder~     pain on the four variables regarding to quality of life (activity, mood, walking and sleep)~     will be assessed using modified Brief Pain Inventory(BPI) questionnaire.~   "
165926|NCT01393899|"~     This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to~     severe Crohn's disease who completed the double-blind induction treatment in Study A3921083~     and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.~   "
165927|NCT01393886|"~     The aim of this study is to find out the safety and efficacy of Laparoscopic Greater~     Curvature Plication (LGCP) procedure. This study procedure is an alternative restrictive~     weight loss surgery that has the potential to reduce the complications associated with~     gastric banding and sleeve gastrectomy by creating a small sized stomach without the use of~     an implant and without cutting stomach.~   "
165928|NCT01393873|"~     Studies conducted assessing diabetic eye disease have shown a progression of diabetic~     retinopathy with rapid improvement of glycemic control during pregnancy and in patients with~     type 1 diabetes. It is also well documented that bariatric surgery may result in rapid~     improvement of glycemic control in obese patients with type 2 diabetes. To our knowledge the~     progression of diabetic eye disease seen in pregnancy and type 1 diabetes has not been~     studied in obese type 2 diabetics undergoing bariatric surgery. To this end, this study will~     examine the effects of rapid glycemic control which is seen in type 2 diabetics following~     bariatric surgery on the progression of diabetic retinopathy.~   "
165929|NCT01393860|"~     The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of~     change in renal function following aliskiren initiation as well as to identify triggering~     events that lead to aliskiren initiation.~   "
165930|NCT01393847|"~     Background:~      - Sickle cell disease often causes crises, with episodes of pain. Many people with sickle~     cell disease also have pain between crises. Inflammation is an important part of sickle cell~     pain. It may be related to levels of nitric oxide. Nitric oxide is a gas in the body that~     helps relax blood vessels and may be related to the pain from sickle cell disease.~     Researchers want to study the relationship between blood levels of nitric oxide and pain in~     people with sickle cell disease. Researchers also want to study how certain genes express~     themselves related to sickle cell pain.~      Objectives:~      - To collect blood samples and other genetic expression information to study sickle cell pain~     and its relation to nitric oxide levels in the blood.~      Eligibility:~        -  People at least 18 years of age who have sickle cell disease.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  This study requires a screening visit and four study visits scheduled 1 week apart. Each~          visit will last about 1 hour.~        -  Participants will be screened with a medical history and physical exam. They will~          complete questionnaires about pain levels (if any). They will also provide blood samples~          for genetic and other testing.~        -  Participants will have a breath test to see how much nitric oxide they exhale. They will~          also have a test of their ability to detect small changes in temperature and touch.~        -  Participants will keep a diary to record daily pain levels and pain medicines taken.~          They will write down what they eat to track foods that contain nitrates (such as meats~          like ham and bacon and vegetables like beets and spinach).~        -  At each of the four study visit, participants will bring the pain diary, provide blood~          samples, and have breath nitric oxide tests.~   "
165931|NCT01393834|"~     This study is being done to evaluate if delaying cord clamping or milking the umbilical cord~     of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies~     among doctors, but there is information that shows that delaying clamping of the umbilical~     cord in premature infants may reduce the rate of the baby needing a blood transfusion,~     decrease the risk of infection and bleeding in the head.~   "
165932|NCT01393821|"~     This clinical trial studies menadione topical lotion in treating skin discomfort and~     psychological distress in patients with cancer receiving panitumumab, erlotinib~     hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin~     discomfort and help alleviate psychological distress and pain in patients receiving treatment~     with panitumumab, erlotinib hydrochloride, or cetuximab~   "
165933|NCT01393808|"~     Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for~     renal disease progression. More proteinuria is associated with faster progression, whereas~     treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic~     chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower~     is the disease progression in the long term. On the basis of the above findings, proteinuria~     has become a target of renoprotective therapy.~      Among different antihypertensive medications, those that inhibit the Renin Angiotensin~     System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor~     blockers (ARBs), are those that at comparable blood pressure control, more effectively reduce~     proteinuria and slow renal disease progression. Thus they have become the key component of~     renoprotective therapy in patients with proteinuric chronic kidney disease. Observational~     studies found that their effectiveness, however, is limited or even fully blunted in patients~     who eat large amount of salt.~      Experimental evidence indicates a renoprotective role of the vitamin D system in chronic~     renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin D~     receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with~     type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor~     therapy. This effect, however, was largely restricted to subjects with daily sodium intake~     exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment with~     paricalcitol appears to be effective in particular in those patients who do not appreciably~     benefit of renin angiotensin system (RAS) inhibitors therapy because of high salt intake.~     Thus, whether the antiproteinuric effect of paricalcitol is modified by concomitant salt~     intake in patients with chronic kidney disease (CKD) on background RAS inhibitors therapy, is~     worth investigating.~      The broad aim of this study is to evaluate the interaction between paricalcitol therapy and~     sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable~     background RAS inhibitor therapy.~   "
165934|NCT01393795|"~     The investigators hypothesise that pre-application of Qutenza® patches to the skin may reduce~     pain at the site of Remodulin® SC infusion (sited 1 to 2 weeks later at the site of Qutenza~     pre-application), in which case it would greatly improve the quality of life of the patients,~     and enable many more to continue with this treatment. It may also provide new information to~     support the use of Qutenza® patches for preventing and reducing pain produced by~     inflammation.~      The present study will explore the efficacy of single applications of Qutenza® (capsaicin 8%~     patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in pulmonary~     arterial hypertension patients, as assessed by changes in subjective pain rating score and/or~     pain and sensory testing.~   "
165946|NCT01393639|"~     The purpose of this study is to compare the safety and efficacy of multiple doses of~     PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo~     in the treatment of rheumatoid arthritis. All subjects will also be receiving background~     treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for~     eight weeks followed by a 4 week period during which the dose of study medication will be~     gradually reduced. The efficacy of the study medications will be determined by assessing~     severity of the rheumatoid arthritis during the study and safety will be determined by~     adverse event reporting, laboratory tests and biomarker analysis.~   "
165947|NCT01393626|"~     This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to~     severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is~     more effective than placebo (inactive drug).~   "
165935|NCT01393782|"~     The investigators propose a dose finding study to determine the feasibility of Angiotensin II~     (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to~     increase mean arterial pressure, this could lead to future pharmacologic development based on~     the AII hormonal pathway. The investigators propose a 20 patient, randomized,~     placebo-controlled, blinded study in the treatment of high-output shock. Patients with~     high-output shock and a cardiovascular SOFA (sequential organ failure score) score of > 4~     will be eligible. In addition, patients must already be receiving cardiac output monitoring~     and have a cardiac index > 2.4 L/min/ 1.73 m2. Patients will be randomized to intravenous AII~     or saline in a blinded fashion. There will be 10 patients in each arm. This is a safety and~     dose finding feasibility study. The investigators are starting with a small cohort consistent~     with similar types of studies. The investigators estimate that ten patients in each arm will~     generate a basis for determining if there is sufficient signal for AII to improve blood~     pressure at the doses outlined. The primary endpoint in the study will be the effect of AII~     on the standing dose of norepinephrine which is required to maintain a MAP of 65 mmHg.~     Secondary endpoints will be the effect of AII on urine output, serum lactate, and creatinine~     clearance. 30 day post dose mortality will also be assessed. Subjects discharged prior to day~     30 will be contacted by telephone for this assessment.~   "
165936|NCT01393769|"~     For selected cases with advanced Retinoblastoma (RTB) intraocular involvement(stage V of the~     Reese-Ellsworth classification) in which enucleation would usually be the standard~     therapeutic approach, in this project the investigators propose an alternative conservative~     treatment using intra-arterial chemotherapy with melphalan, via direct administration by~     catheterization of the ophthalmic artery.~   "
165937|NCT01393756|"~     The purpose of the study is to assess the efficacy of the association of Lenalidomide~     (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone)~     in a population of patients with follicular lymphoma as measured by the response rate at the~     end of treatment.~   "
165938|NCT01393743|"~     This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of~     perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and~     adults maintained on one to two stable antiepileptic drugs (AED).~   "
165939|NCT01393730|"~     The purpose of this research study is to determine if the addition of dutasteride to a~     regimen with abiraterone acetate and prednisone will improve on therapy in patients with~     castrate-resistant prostate cancer and metastatic disease. This study will also help~     determine the side effects of the study treatment and how often they occur.~   "
165940|NCT01393717|"~     This phase II trial studies how well brentuximab vedotin before autologous (taken from an~     individual's own cells) stem cell transplant works in treating patients with Hodgkin~     lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer~     growth in different ways by targeting certain cells.~   "
165941|NCT01393704|"~     The main purpose of this study is to compare blood loss at the time of laparoscopic or~     robotically-assisted laparoscopic myomectomy when using different amounts of dilute~     vasopressin solution. Myomectomy is a surgical procedure to remove fibroids from the uterus.~     Vasopressin is a synthetic drug used to help decrease blood loss at the time of gynecologic~     surgery; although very little is know about the optimal dosage and administration.~      The investigators plan to perform a randomized clinical trial on patients scheduled for~     minimally invasive myomectomy. All patients will get the same overall amount of vasopressin.~     Patients will be assigned by chance to one of two groups: one group will receive higher~     volume of a more dilute vasopressin solution. The other group will receive a lower volume of~     a more concentrated solution. The investigators will collect information on operative blood~     loss and complications related to surgery.~   "
165942|NCT01393691|"~     Nighttime fears (NTF) and sleep disruptions in preschool children continue to be major~     problems in clinical services. The aim of this study is to test the efficacy of two~     interventions designed for preschool children suffering from NTF: (a) a CBT adaptation~     combining parent involved play, which will include multiple standard cognitive-behavioral~     techniques, namely psycho-education, problem solving via play, gradual exposure and~     reinforcement management; and (b) Triadic Expressive Play Therapy, based on Virginia Axline's~     (1947) eight basic principles of play therapy. Parents will take an active part both in and~     in between treatment sessions in both intervention groups. In addition to the review of the~     outcomes of these interventions, the proposed study aims to identify variables that moderate~     and mediate treatment effects.~      In an attempt to meet these aims, the investigators will recruit 90 children suffering severe~     NTF and their parents who seek treatment. At baseline the investigators will assess~     children's NTF and general fears, sleep patterns and disruptions, behavior problems and~     potential moderators (i.e. playfulness, oppositionality, desire for control and parental~     anxiety). Assessment will be based on both objective and subjective measures, including~     interviews with the child and parents, questionnaires and actigraphy. The investigators will~     then randomly assign these children to one of two conditions: CBT with parent involved play~     or Triadic expressive play therapy. Possible mediators (i.e. the therapeutic alliance,~     patient compliance, motivation etc.) will be evaluated after each of the active intervention~     sessions. The effects of the interventions will be assessed by comparing four time points:~     baseline, first week of intervention, 1 month and 6 months subsequent to administration.~      The main hypotheses of the proposed study are: (a) A positive correlation will be found~     between the severity of NTF and the severity of sleep disruption at baseline, and a reduction~     in NTF will be associated with an improvement in sleep; (b) Both interventions will~     significantly reduce nighttime fears, but greater impact will be evident in the CBT group;~     (c) Higher levels of playfulness and lower levels of oppositionality and desire for control,~     as well as parental anxiety will predict desirable outcomes. (d) Stronger therapeutic~     alliances, in addition to higher levels of motivation and compliance will be associated with~     greater intervention effectiveness.~   "
165943|NCT01393678|"~     The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and~     garlic oil. This components showed synergistic enhancing effects in previous tests. In phase~     2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on~     above, this study is phase 3 test to prove efficacy and safety of PENNEL.~   "
165944|NCT01393665|"~     The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic~     oil. The two components were confirmed to have complementary effects because of different~     operational mechanism in animal experiments, and were examined on humans in this study. Both~     BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity~     caused by toxic substances, and the purpose of this study is to confirm efficacy of and~     safety on human body of the agent and to determine its optimal dose.~   "
165945|NCT01393652|"~     This is a two part study. The purpose of the first part (Part A) is the evaluation of the~     pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The~     second part (Part B) of this study will focus on the exploratory pharmacodynamics of~     PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses~     selected in Part B will have been administered previously in the Part A of the study.~   "
165949|NCT01393600|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses~     (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive~     dyskinesia in subjects with schizophrenia or schizoaffective disorder.~   "
165950|NCT01393587|"~     Recently, a new synthetic marker was developed, based on a molecule that is composed of Amino~     Acids and Linoleic Acid and Neucleic Acid, which is capable of detecting even minor changes~     of oxidative stress.~      The investigators would like to assess the usefulness of this marker during positive pressure~     pneumoperitoneum, during laproscopic surgery, with or without intenstinal resection (ischemia~     induced by intra-abdominal pressure and vascualr compromise).~   "
165951|NCT01393574|"~     The study hypothesis is that some children with Attention-Deficit-Hyperactivity-Disorder~     (ADHD) who also have sleep onset difficulties will improve with Melatonin treatment to an~     extent similar to that of stimulants treatment.~      In order to check this hypothesis children with a new ADHD diagnosis who also have sleep~     difficulties will be treated with either Melatonin or with stimulants (Methylphenidate) for~     one month. The main outcome will be improvement of the ADHD symptoms.~   "
165952|NCT01393561|"~     This is a multicenter clinical trial, phase III, superiority, controlled by active medicine,~     double-blind, randomized, enroll 166 children, over 12 years old, with acute inflammation~     upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and~     a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel~     groups, and will receive the medicines of study, according of the randomization.~   "
165953|NCT01393548|"~     This is a multicenter clinical trial, phase III, non-inferiority, controlled by active~     medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation~     upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and~     a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel~     groups, and will receive the medicines of study, according of the randomization.~   "
165954|NCT01393535|"~     The purpose of this study is to investigate the relationship between serum adiponectin and~     clinical prognosis in patients undergoing cardiac surgery.~   "
165955|NCT01393522|"~     The purpose of this study is to determine if milnacipran taken twice daily is effective in~     reduction of headache pain.~   "
165956|NCT01393509|"~     NOTE: This study is now recruiting only patients with Myeloproliferative Neoplasms (MPN).~     Dose escalation has been completed.~      The purpose of this study is to test a new drug, called PU-H71 for the first time in humans,~     to find out what effects, good or bad, this new drug has on the patient and the cancer at~     different dose levels. PU-H71 blocks a protein called Heat Shock Protein-90 (Hsp90). Hsp90 is~     found in both normal and cancer cells, but may be more important in cancer cells. Attacking~     Hsp90 can stop the function of certain proteins that are needed for cancer cells to survive.~     The diseases that are part of this study may be especially sensitive to attacking Hsp90, and~     the investigators have seen signs of disease control in patients with MPN. This study is~     currently enrolling a cohort expansion for patients with myeloproliferative neoplasms (MPN).~   "
165957|NCT01393496|"~     To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on~     long-term neurodevelopmental outcome in extremely low birth weight infants.~   "
165958|NCT01393483|"~     The purpose of this study is to find out whether a protein, called mesothelin, found in the~     blood and tissue can be used as marker for esophageal cancer. Doctors at Memorial~     Sloan-Kettering Cancer Center would like to compare levels of this protein in patients with~     abnormal cells or tissue of the esophageal to the levels of this protein in patients being~     treated for cancer for the esophagus.~   "
165959|NCT01393470|"~     Summary~      For ethical and practical reasons pre-licensure clinical efficacy phase III trials for GSK~     Biologicals' HPV-16/18 LI VLP AS04 vaccine used cervical intraepithelial grade 2 and above~     (CIN2+) lesions as surrogate efficacy endpoint for cervical cancer. The long-term impact of~     HPV vaccination on cervical cancer as well as other HPV-related non- cervical cancers is,~     however, an area warranting further exploration in the post-licensure setting. Results of the~     multinational phase III trial demonstrated high vaccine efficacy against CIN2+ associated~     with HPV-16 and/or HPV-18, significant vaccine efficacy against CIN2+ and CIN3+ irrespective~     of HPV type in the lesion as well as evidence of protection against CIN2+ associated with HPV~     types 31 and 45 [Paavonen, et al. 2009]. Over time, vaccinated cohorts should benefit from a~     substantial reduction in the incidence of cervical cancer considering impact on oncogenic~     non-vaccine HPV types. This long-term study is conducted to evaluate the long-term impact of~     GSK Biologicals' HPV-16/18 vaccine on the occurrence of cervical pre-cancerous lesions and~     cervical cancer with the following objectives:~        -  To assess the long-term efficacy of the HPV-16/18 L1 VLP AS04 vaccine on the occurrence~          of cervical cancer including its immediate precursors (CIN3+): cervical intraepithelial~          neoplasia grade 3 (CIN3) and adenocarcinoma in situ (AIS) by comparing cohorts A and C~          (see below).~        -  To assess the efficacy of HPV-16/18 L1 VLP AS04 vaccine on the occurrence of the~          following potentially HPV related non-cervical cancers such as vulvar intraepithelial~          neoplasia, vaginal intraepithelial neoplasia, anogenital neoplasia and oropharyngeal~          neoplasia by comparing cohorts A and C (see below)~        -  To assess as an explanatory objective the occurrence of CIN3+ breakthrough cases~          associated with HPV-16 or HPV-18 infection in subjects vaccinated with HPV-16/18 L1 VLP~          AS04 vaccine by close surveillance of cohorts and cross vaccinated cohort B (see below)~      This prospective, observational cohort study is undertaken in originally 16-17 year-old~     Finnish females who have participated in the GSK Biologicals' HPV-008 trial (NCT00122681)~     with regular clinical follow-up, and can be divided in Cohort A: Female subjects from Finland~     who received HPV-16/18 L1 VLP AS04 vaccine in the HPV-008 study between May 2004 and May 2005~     (N=2409), and Cohort B: Female subjects from Finland who received the Hepatitis A control~     vaccine in the HPV-008 study (N=2399). All subjects were offered the HPV-16/18 L1 VLP AS04~     vaccine or screening for cervical cancer at the end of the study (age 21-22): 50% of the~     subjects, chose not to take cross-over HPV vaccination at HPV-008 study end. Referent Cohort~     C: A population-based reference cohort of female subjects from Finland who have not been~     exposed to any HPV vaccine (either during a HPV vaccine trial, or commercially available~     vaccine; i.e. Cervarix or Gardasil), enrolled in this study in May - September 2003 or May -~     September 2005, altogether 15536 subjects).~      Prospective data collection will start at the HPV screening invitation for each subject in~     2013. Several analyses are planned including an analysis at 8 years post-completion of the~     HPV-008 study (by 2020) and will provide a total evaluation time of approximately 15 years~     since first vaccination in the Cohort A.~      The study is self-contained for the primary and secondary endpoints. Data from the HPV-008~     trial will be used to address exploratory objectives mentioned above. Data collection will be~     performed using the databases from the University of Tampere.~   "
165960|NCT01393457|"~     The purpose of this study is to evaluate treatments designed to improve cocaine treatment~     success by combining medications that target cocaine-related cognitive impairments.~   "
165961|NCT01393444|"~     The purpose of this research study is to demonstrate that individuals with upper limb~     paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis~     and brain stem stroke can successfully achieve direct brain control of assistive devices~     using an electrocorticography (ECoG)-based brain computer interface system.~   "
165962|NCT01393431|"~     Measurement of pH in Exhaled breath condensate has been mentioned as a robust variable from~     lung inflammation. It is non-invasive and reproducible. The investigators measured pH in the~     water condensed in the trap of expiratory arm of ventilator.In ICU the investigators measured~     pH in condensed water without interfering with patients treatment. A group of critically ill~     patients mechanically ventilated due to non pulmonary cause were followed until successful~     weaning, death or pneumonia. The investigators found that pH did not change along the study~     and it did not predict worsening condition.~   "
165963|NCT01393418|"~     The purpose of the study is to evaluate kidney biomarkers and determine if there is a~     correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac~     surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and~     managing patients at risk for kidney failure after cardiac surgery. To evaluate~     Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass~     period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).~   "
165975|NCT01393262|"~     The purpose of the research is to investigate multiple facets of non-traumatic and traumatic~     health issues. The majority of our research deals with mind-body aspects of health. The~     investigators often correlate different psychological measures against one another or match~     psychological and depression scores against standard of care objective measurements (grip~     strength and range of motion).~      The data repository also serves to streamline our studies and amalgamate many studies that~     are no more than minimal risk and do not involve randomization in any way.~   "
165976|NCT01393249|"~     The purpose of this study is to create a model enabling us to predict pancreatitis,~     hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with~     Acute Lymphoblastic Leukemia.~   "
165977|NCT01393236|"~     Based on prior findings concerning sleep disturbances, in particular REM sleep disturbances,~     after fast-track hip and knee arthroplasty (H-2-2010-011) we performed a supplemental~     analysis of heart rate variablity after arousals during sleep. We compared preoperative and~     postoperative results.~   "
165964|NCT01393405|"~     There are fewer therapeutic options for patients with active ulcerative colitis (UC) compared~     to patients with active Crohn's disease (CD) and the investigators are facing a persistent~     unmet need for additional effective and affordable therapies for patients with UC.~     Methotrexate (MTX) 25 mg once weekly administered subcutaneously (sq) or intramuscularly (im)~     is an efficient therapy to induce and maintain steroid free remission in patients with CD. To~     evaluate the efficacy of a similar approach in patients with active ulcerative colitis the~     investigators conduct a double-blind, placebo controlled, randomized, multicenter, parallel~     group trial to investigate the safety and efficacy of 25 mg MTX applied subcutaneously once~     weekly in patients with active UC, who either failed 5-ASA therapy, or are steroid dependent~     or are intolerant or not responding to azathioprine/6-mercaptopurine therapy or have no~     response/ lost response to infliximab prior to the study inclusion. The study is designed as~     a drug withdrawal trial and includes two periods, the Induction Period (week 0-16) and the~     Maintenance Period (week 17-48). In the open label Induction Period every patient will~     receive a steroid taper, MTX 25 mg sq once weekly + daily folic acid 1 mg tablets for the~     induction of clinical response or remission. Patients responding to the open label MTX~     therapy and being off steroids between week 12-16 will be randomized at week 16 1:1 to~     Placebo sq once weekly + daily folic acid 1 mg tablets + 2.4 g mesalamine or to MTX 25 mg sq~     once weekly + daily folic acid 1 mg tablets+ 2.4 g mesalamine. The Specific Aims of the trial~     are: i) To evaluate the safety and tolerability of 25 mg MTX applied sq once weekly over a~     time period of 48 weeks; ii) To evaluate the relapse-free survival of MTX maintenance therapy~     compared to placebo over a time period of 32 weeks; iii) To evaluate the efficacy of MTX over~     a time period of 16 weeks to induce steroid free remission; iiii) To establish a DNA, plasma~     and serum library to enable the evaluation of clinical and pharmacogenomic models to predict~     the response to MTX therapy in patients with UC. With 25-30 participating centers actively~     enrolling, the investigators anticipate to complete enrollment for this study in a time~     period of 3 years. Completion of this trial will define the therapeutic value of MTX in UC,~     potentially changing the current therapeutic strategy in UC.~   "
165965|NCT01393392|"~     The purpose of this study is to pilot and evaluate, in a randomized controlled trial, the~     immediate and long-term effects of a newly developed, tailored, intensive smoking cessation~     intervention among methadone maintained smokers and compared to a control condition~     (facilitated referral to the NJ Quitline). The newly developed intervention is evidence~     based, addresses the unique needs of methadone maintained smokers, is intensive, can be~     tailored to the individual, and builds on the strengths as well as addresses the gaps in~     previous treatments for methadone maintained smokers.~      The investigators hypothesize that: (1) three months and six months after beginning~     treatment, those in the tailored intervention condition will be more likely to be abstinent~     from smoking than those in the control intervention condition (primary outcome); (2) there~     will be a greater relapse rate in the control intervention condition between the three and~     six month follow-up points than in the tailored intervention condition; (3) three and six~     months after beginning treatment, those in the tailored intervention condition will have~     better secondary smoking related outcomes (smoked fewer cigarettes per day in the past week,~     be more ready to quit, have greater self-efficacy for quitting, experience less nicotine~     dependence, and be more likely to have made a quit attempt) than those in the control~     intervention condition; (4) three and six months after beginning treatment, those in the~     tailored intervention condition will have better utilization of and adherence to smoking~     cessation pharmacotherapy, better mental and physical health, less perceived stress, greater~     social support, less drug and alcohol use, and greater involvement in drug and alcohol~     treatment than those in the control intervention condition; and (5) the newly created~     tailored intervention will be feasible and acceptable. .~   "
165966|NCT01393379|"~     The purpose of this study is to investigate the effect of endoscopic valve implantation in~     patients with COPD and PH on hemodynamics, symptoms, exercise tolerance and quality of life~     in 10 patients in a prospective study. An improvement of objective parameters may also have a~     prognostic significance~   "
165967|NCT01393366|"~     The investigators plan to conduct a nurse-based telephone intervention study to minimize~     toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab~     (FCR) given frontline to Chronic Lymphocytic Leukemia patients.~   "
165968|NCT01393353|"~     The study evaluates a computerized cognitive therapy in patients with Parkinson's disease who~     have a mild cognitive impairment or mild dementia. The control group is trained using~     Nintendo Wii. The main outcome parameter is a neuropsychological evaluation.~   "
165969|NCT01393340|"~     This pilot study is a double-blinded, randomized controlled, two-centre trial in which~     subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or~     placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE).~     During the treatment period and follow-up, the clinical efficacy of the treatment will be~     assessed by evaluation of symptoms, Quality of Life questionnaire, morning Peak Expiratory~     Flow measurement, smell test, nasal endoscopy, CT-scan, peak nasal inspiratory flow and~     spirometry. Biological activity will be evaluated by measuring peripheral and local (in~     serum, in nasal secretions, biopsies) markers of inflammation.~      Study hypothesis~        1. Evaluation of the efficacy and safety of anti-IgE (Omalizumab) in patients with nasal~          polyposis and comorbid asthma.~        2. Exploration of anti-IgE effects on local and systemic metabolism of IgE in nasal~          polyposis~        3. Clinical assessment of the IgE theory in the pathogenesis of nasal polyps~   "
165970|NCT01393327|"~     Purpose of this study is to investigate whether and to what extent a cautious respiratory and~     movement therapy can complement medical treatment and the condition, oxygen uptake, quality~     of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk~     distance in patients with pulmonary hypertension.~   "
165971|NCT01393314|"~     This is a randomized controlled trial of telemonitoring vs usual care provided by home care~     agencies for atients with HF.~      The study hypothesis is that Telemonitoring will reduce hospital re-admission rates, urgent~     care visits, unscheduled physician appointments, ER visits in patients with heart failure~     over the 60 day post hospitalization period.~   "
165972|NCT01393301|"~     During the 1-year formative phase of a study to develop an integrated treatment for quitting~     smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up~     activities will include piloting the integrated treatment on a small group of individuals (N~     = up to 12), obtaining expert consultant and participant feedback, and development of the~     final treatment manual and procedures. The goal during this phase will be to establish~     feasibility of treatment delivery, participant acceptability, and potential for a treatment~     effect before conducting a pilot randomized trial of the treatment. During the two-year pilot~     RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral~     and pharmacological smoking cessation intervention for HIV+ smokers with interfering~     psychological distress.~   "
165973|NCT01393288|"~     Every year, more than 5 million patients in the US experience postoperative nausea and/or~     vomiting (PONV) and in the ambulatory setting post-discharge nausea and/or vomiting (PDNV) is~     the most common cause for unanticipated hospital re-admissions. Similarly, millions of~     patients suffer from chemotherapy induced nausea and/or vomiting (CINV), and one out of five~     patients discontinues chemotherapy for this reason. Thus, the control of nausea and vomiting~     remains a major health concern for the investigators society. The investigatorsoverall goal~     is to further the understanding of nausea and vomiting and optimize antiemetic selection in~     order to facilitate individualized patient care.~      Unfortunately, current antiemetics reduce the incidence of nausea by only about one third. As~     a result, antiemetics are often combined, exposing patients to adverse events and drug~     interactions without evidence for the most effective combination. Moreover, it remains~     unclear why such a large amount of inter-individual variability exists in antiemetic~     responsiveness. 5HT3, NK1, and GABA receptors are targets for some of the most commonly~     prescribed anti-emetics. Furthermore, these receptors have many known genetic polymorphisms,~     including several linked to incidence of nausea and vomiting. Thus pharmacogenomic variation~     may in part explain interindividual differences in treatment responses and will be tested in~     this proposal.~      Leveraging the established infrastructure of the UCSF Clinical and Translational Science~     Institute, and the support of 6 patient recruitment sites, the investigators will enroll 1280~     high risk patients to three oral interventions with distinct mechanisms of action for nausea~     and vomiting. Investigating nausea and vomiting in ambulatory surgical patients is an~     excellent model for this trial owing to a high incidence, short observational period, and the~     ability to standardize and control potentially confounding variables. In this proposal, 100%~     of patients will receive a single intraoperative dose of 4 mg ondansetron, which is similar~     to the 80% of patients who receive prophylaxis in common practice. Using a factorial design,~     these patients will be randomized to receive one out of eight possible combinations of the~     three interventions (ondansetron, aprepitant, lorazepam) versus placebo (ond+aprep+lora,~     ond+aprep, ond+lora, aprep+lora, ond, aprep, lora, or placebo). Thus, in this proposal 87.5%~     (7 out of 8 patients) will have antiemetic coverage for the postdischarge period, which is~     considerably higher than in common practice, where only 4% of patients have antiemetic~     coverage after discharge. The primary endpoint will be the prevention of nausea and vomiting~     within 48 hours after ambulatory surgery. The advantage of the factorial trial design is its~     high efficiency to systematically investigate multiple interventions while allowing us to~     test for potential interactions. It is also an ideal format for the simultaneous assessment~     of pharmacogenomic interactions of antiemetics in this proposal.~      To this end, the investigators will collect DNA samples and take advantage of the unique~     opportunity to investigate the effects of variation in candidate receptor genes in the~     context of the three treatment interventions for PDNV. This approach may in part explain~     inter-individual differences in drug efficacy and allow for future screening of at-risk~     patients. Specifically, the investigators will be assessing single nucleotide polymorphisms~     (SNPs) and copy number variants (CNVs) of targeted receptors for the antiemetics tested.~      Aim 1: To determine efficacy of three interventions for the prevention of PDNV.~      Hypothesis 1.1: Each intervention reduces the incidence of PDNV.~      Hypothesis 1.2: Efficacy of all interventions is independent so that efficacy of a~     combination can be derived from the efficacy of the individual interventions.~      Aim 2: To determine if drug response for anti-emetics is dependent upon genetic variance.~      Hypothesis 2: Efficacy of ondansetron, aprepitant and lorazepam to reduce PDNV differs with~     5HT3, NK1, and GABA receptor gene variation, respectively.~   "
165974|NCT01393275|"~     The purposes of the study are~        -  to determine if a supervised exercise intervention is improving the metabolic parameters~          in type 2 diabetes patients~        -  to investigate what kind of intervention (strength endurance training versus combined~          strength endurance training and rehabilitation exercise intervention)is more effective~          in improving the metabolic parameters in patients with type 2 diabetes~        -  to assess which exercise intervention induces higher effects to the metabolic rate and~          cardiac and pulmonary capacity~        -  to investigate what kind of intervention includes highest effects in long term~          persistence of these positive effects~   "
166015|NCT01392742|"~     This observational study will evaluate predictors of early on-treatment response and~     sustained virological response in patients with chronic hepatitis C receiving Pegasys~     (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24~     or 48 weeks) and 24 weeks after the end of treatment.~   "
165978|NCT01393223|"~     The purpose of this study is to assess the safety and tolerability of two doses of LP08~     compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly~     different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis~     design will be employed, i.e. the measured outcomes will be subjects' improvements in~     quantitative and qualitative measures of the disease condition being assessed prior to and~     after LP-08 instillations at four and eight weeks follow-up visits~   "
165979|NCT01393210|"~     Obesity is an important health problem of modern civilization. In Western societies, almost~     half of the adult population has problems with an increased body weight. Products containing~     nutritional fiber has been used by humans for thousands of years. However, beta-glucan as~     biologically active compound, present in these products, has been identified relatively~     lately. This substance is a polymer of glucose and is present in two forms: 1,3D-1,6D and~     1,3D-1,4D.~      Water-insoluble beta-glucan (1,3D-1,6D) has immunomodulatory properties. The aim of the study~     was the assessment of the influence of beta-glucan 1,3D-1,6D added to the low-calorie diet on~     insulin sensitivity and the expression of selected proinflammatory cytokines in adipose~     tissue and peripheral blood mononuclear cells (PBMC) in obese humans with normal glucose~     tolerance.~      The study group consisted of 40 subjects with marked overweight or obesity (body mass index,~     BMI > 28 kg/m2), without serious concomitant diseases not taking drugs affecting glucose or~     lipid metabolism, nonsmokers. Only volunteers, who gave written informed consent, after~     receiving a full information about the aim and the design of the study, were recruited.~      At the beginning of the study, after subjects' qualification to the project and before the~     dietary intervention, the investigators performed:~        -  anthropometric measurements.~        -  oral glucose tolerance test.~        -  euglycemic hyperinsulinemic clamp.~        -  PBMC isolation before and after the clamp.~        -  biopsy of subcutaneous adipose tissue before the clamp.~        -  isolation of mRNA from PBMC and adipose tissue. Then, the expression of the selected~          genes with the Real Time PCR was measured.~        -  After the initial visit, participants received detailed instructions about low-calorie~          diet, with the aim of reduction of 5-7% of body weight and the examples of menu for 14~          days.~      Then, participants were randomly assigned to a group receiving or not beta-glucan~     preparation, as a addition to the low-calorie diet. Each group consisted of 20 subjects.~     Subjects assigned to a group receiving beta-glucan, received the preparation (BETA GLUCAN~     1,3-1,6 Laboratoria Natury 500mg) together with the detailed instruction of its usage. This~     preparation is used as a non-prescription diet supplement, and the dose of 500 mg daily is~     indicated by the manufacturer.~      After 12 weeks of low-calorie diet, without or with beta-glucan, all the examinations~     performed at the beginning of the study were repeated.~   "
165980|NCT01393197|"~     The purpose of this study is to evaluate the effects of Transcatheter Arterial~     Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is~     better,KMG microsphere or lipiodol?~   "
165981|NCT01393184|"~     Radiotherapy alone is generally the only treatment in old patients with SCCHN. No evidence~     indicates combination with EGFR Target therapy can bring benefit for the patients. Senile~     Society is coming in China, the mean age in Beijing reaches 80 years old. A valuable~     treatment with efficacy and safety is needed for senile patient with SCCHN. The purpose of~     the study Prospective, Randomized, Controlled, Phase II Multiple Centered Clinical Trial of~     Nimotuzumab Combined with Radiotherapy for Senile Locally Advanced SCCHN was sponsored to~     evaluate the efficacy and safety for Nimotuzumab Combined with Radiotherapy in Senile SCCHN~     patients.~   "
165982|NCT01393171|"~     The purpose of this study is to evaluate the success rate of cystocele repair using~     polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a~     prospective randomized fashion. The study will be performed in a randomized, prospective,~     single-blinded fashion.~   "
165983|NCT01393158|"~     The purpose of this study is to obtain preliminary data regarding the safety and tolerability~     of apremilast in AD to support the design of larger controlled studies.~   "
165984|NCT01393145|"~     A study multicenter, phase III, randomized, open label study to evaluate the efficacy and~     safety of a fixed-dose combination of formoterol/fluticasone and salmeterol/fluticasone in~     patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) that will~     enroll 336 subjects aged ≥ 40 years, smokers or former smokers, diagnosed with chronic~     obstructive pulmonary disease, classified as moderate chronic obstructive pulmonary disease~     or severe according to GOLD spirometric classification. The subjects will be allocated in 2~     parallel groups and will receive the medicines of study, according of the randomization~     during a 24-week.~   "
165985|NCT01393132|"~     Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced~     day-to-day function and significant discomfort. Tear substitutes are an important part of the~     treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often~     remains very irregular due to poor surface healing.~      The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal~     surface and has been studied in patients with recalcitrant corneal ulcers and erosions with~     significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May,~     2010).~      The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface~     healing, may be able to promote healing of the corneal surface allowing for more conventional~     modalities to take over and maintain a smooth and regular ocular surface. The investigators~     hope to be able to demonstrate an improvement in visual acuity, surface healing and a~     reduction in dry-eye related symptoms.~   "
165986|NCT01393119|"~     The purpose of this study is to determine the appropriate loading and maintenance dose of~     GTx-758 to reach and maintain castration for the duration of the study.~   "
165987|NCT01393106|"~     This study will evaluate the efficacy and safety of idelalisib in participants with relapsed~     of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall~     response rate.~      Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg~     twice daily. Treatment with idelalisib will continue until tumor progression or unacceptable~     toxicity.~   "
165988|NCT01393093|"~     The purpose of the study is to evaluate the effects of Transcatheter Arterial~     Chemoembolization (TACE) with KMG microsphere in treating advance-stage Hepatocellular~     Carinoma(HCC).~   "
165989|NCT01393080|"~     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located~     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical~     efficacy has been shown in adults with head and neck cancer. This study assesses the efficacy~     and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy in~     patients with NSCLC. This is a randomized, muti-center sites trial of this treatment.~   "
165990|NCT01393067|"~     Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic~     liver transplantation. This study compares endoscopic treatment with implantation of multiple~     plastic endoprostheses vs. use of a removable, covered self-expandable metal stent (cSEMS).~   "
166016|NCT01392729|"~     This prospective observational study will evaluate the efficacy and safety of Avastin~     (bevacizumab) in combination with interferon alpha 2a in patients with previously untreated~     metastatic renal cell cancer. Data will be collected from each patient for up to 4 years.~   "
165991|NCT01393054|"~     Despite of the development of new anti hypertensive agents, hypertension in elderly is still~     a big health problem. Nigella sativa seed extract, derived from a small plant originating in~     Middle east which can be found abundantly in Asia, has shown small antihypertensive effect in~     adult. Diuretic effect of Nigella sativa is thought to be the main mechanism for the effect~     but as it also shows anti-inflammatory and vasodilatory activity which are important~     contributors in arterial stiffness, the main pathogenesis of hypertension in elderly, thus it~     has a superior potential benefit for this population. We will conduct a randomized, double~     blind, placebo-controlled trial to prove the effect of Nigella sativa seed extract in elderly~     patients with hypertension. Our hypothesis is 300 mg Nigella sativa seed extract twice daily~     will have anti-hypertensive effect in the blood pressure of elderly with hypertension.~   "
165992|NCT01393041|"~     The purpose of this clinical study is to assess device deployment characteristics and~     performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6~     French device utilizing the SJM collagen.~   "
165993|NCT01393028|"~     Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve~     the workup of patients with stable chest pain complaints. The objective of the study is to~     compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven~     workup of suspected coronary artery disease in comparison to the standard workup using stress~     testing.~   "
165994|NCT01393015|"~     Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver~     automatically oxygen and to enable a remote medical monitoring with a homogeneous patient~     population hospitalize for Chronic obstructive pulmonary disease (COPD)exacerbation.~      Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses~     and medical personnel and there are advantages to use this system. In comparison with the~     common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a~     better control of the oxygen saturation in function of designed target, reducing the~     desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical~     way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse~     personnel and to improve the support with centralized monitoring in the FreeO2 group.~   "
165995|NCT01393002|"~     This is a structured web-based survey in selected hospitals with intensive care units in~     Berlin- Brandenburg that will focus on the analysis of current knowledge in ICUs in the field~     of invasive mycoses.~   "
165996|NCT01392989|"~     Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a~     treatment option for patients with Myelodysplasia or Myeloproliferative Disorders. During the~     course of this study, we will attempt to learn whether a particular type of blood cell,~     called a Cytokine Induced Killer (CIK) cell may add benefit to allogeneic stem cell~     transplantation. CIK cells are present in small quantities in the bloodstream but their~     numbers can be expanded after a brief period of nurturing in a laboratory.~   "
165997|NCT01392976|"~     The purpose of this study is to compare the pharmacokinetic and safety profiles of two~     formulations of CO-1.01 in patients with Advanced Solid Tumors.~   "
165998|NCT01392963|"~     A 24-week Randomized, Double-blind study treating people who suffer from depression who also~     have moderate to severe frown lines in forehead region with Botox injections. Subjects~     participating will have their photos taken and complete a questionnaire regarding their~     depression. They will see a psychiatrist at every visit who will assess their depression.~   "
165999|NCT01392950|"~     A clinical study report follows; this clinical study evaluated the safety and efficacy of~     SAUFLON CLARITI Soft Silicone Hydrogel Contact Lens with UV Blocker by comparison with Air~     Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.).~      Subjects used OptiFree Replenish solution (Alcon Laboratories Inc.) for daily lens~     maintenance, care and storage.~   "
166000|NCT01392937|"~     A clinical trial was conducted to assess the safety and acceptability of the Sauflon~     Multipurpose Solution when used with four different silicone hydrogel contact lens brands and~     one conventional hydrogel control lens was conducted over a period of two months, with a~     control group using Ciba Vision Aquify Multi- Purpose Solution. The study was conducted at~     six investigator sites and a total of 257 subjects were enrolled. The results of this study~     showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose~     Solution to the predicate device for its intended use.~   "
166001|NCT01392924|"~     Primary Objective:~      - To confirm safety and tolerability of global recommended phase three dose (RPTD) of~     SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with~     solid tumors.~      Secondary Objectives:~        -  To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408~          in CDD treatment schedule in patients with solid tumors.~        -  To gather preliminary efficacy data after repeated administration of SAR245408 in~          patients with solid tumors.~   "
166002|NCT01392911|"~     This is the first trial in a series of clinical trials that aim to bring the concept of high~     dose rifampicin beyond phase II of clinical development.~      The safety, tolerability, extended early bactericidal activity (EBA) and pharmacokinetics of~     several doses of Rifampicin with or without standard doses of Isoniazid, Pyrazinamide and~     Ethambutol in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB will~     be assessed. The objective of this study is to find the maximum tolerable dose of Rifampicin~     as monotherapy and in combination with the currently available Isoniazid, Pyrazinamide and~     Ethambutol.~      The subjects will be in the study for 24-31 days. After a screening period of 9-3 days, the~     subjects will receive treatment with Rifampicin as single drug during 7 days (monotherapy).~     This treatment will be followed by treatment with 7 days of Rifampicin and Isoniazid,~     Pyrazinamide and Ethambutol (combination therapy), and 7-8 days treatment with standard TB~     medication.~      All subjects will be closely monitored for side effects. This monitoring will include daily~     interviews and physical examination, and ECG evaluation and blood and urine analyses at~     specific intervals.~      During the 7 days of monotherapy, after the second day of the combination therapy and at the~     end of the combination therapy, overnight sputum will be collected from the patients to~     investigate the potency of high dose rifampicin to reduce this number of bacilli.~      The Rifampicin dose will be increased step by step and group by group. The control group will~     receive the standard dose of 10 mg Rifampicin/kg, whereas the first treatment group will~     receive 20 mg/kg. The Rifampicin dose will only be further increased for a next group of~     patients, if this is expected to be safe.~      Rifampicin is widely available and not expensive. Physicians all over the world have~     experience with this drug and its adverse effects. Should this study be successful, the~     highest dose of Rifampicin that this safe and tolerable will be given to a larger group of~     patients. in the next study.~      If increasing the dose of Rifampicin proves to be safe and effective, a higher dose of~     Rifampicin could be implemented broadly and quickly, and it would benefit many patients~     worldwide.~   "
166017|NCT01392716|"~     This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in~     treatment-naive patients with non-bulky follicular non-Hodgkin`s lymphoma. The anticipated~     time on study treatment is 3 months.~   "
166018|NCT01392703|"~     The purpose of the study is to compare the blood levels of dasatinib in healthy participants~     who received tablet formulation with those of healthy participants who received liquid and~     tablet-dispersed formulations of the drug.~   "
166003|NCT01392898|"~     Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2~     diabetes. Although insulin is an effective treatment modality, this is often at the expense~     of significant weight gain. Weight gain is obviously undesirable in an already overweight~     population, but may also deter further optimization of insulin therapy. Large~     inter-individual differences exist in the level of weight gain after initiation of insulin~     therapy, but no clear predictive factors have prospectively been identified thus far.~      Liraglutide (Victoza®), a human glucagon-like peptide-1 (GLP-1) analogue, improves glycaemic~     control and reduces weight. We hypothesize that in patients who show (excessive) weight gain~     after introducing insulin therapy, adding liraglutide is effective in reversing body weight~     while preserving glycaemic control.~   "
166004|NCT01392885|"~     To determine the effects of aerobic exercise on hippocampal volumes and severity of psychotic~     symptoms in a population of psychosis patients compared to healthy age/gender matched~     volunteers. Psychosis patients often suffer from a number of cognitive difficulties,~     including poor memory function, poor problem-solving capacity and difficulties with attention~     and concentration. These problems are not well addressed by current clinical treatments.~     Evidence from aging research strongly suggests that increased cardiovascular fitness may~     provide numerous cognitive benefits by promoting brain growth, particularly in the frontal~     lobes and the hippocampi. The current study will measure the effects of aerobic exercise on~     brain volumes in a population of chronic psychosis patients to determine if 1) hippocampal~     volumes increase in response to exercise and 2) if parallel improvements in cognitive~     functioning occur.~   "
166005|NCT01392872|"~     Multiple Sclerosis is the first cause of neurological handicap in France. The importance of~     cognitive disabilities, their evaluation and their impact on patients' life have only been~     comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS)~     but imply a lot of constraints. This study will evaluate the impact of these treatments on~     cognitive disabilities, tiredness state, emotion and quality of life in general, on a~     lengthened period.~   "
166006|NCT01392859|"~     Asthma, a chronic disease which produces significant morbidity and mortality in children, is~     a significant health problem to a large segment of society. Despite considerable advances in~     the diagnosis and treatment of asthma over the past several years, a sizeable portion of~     patients do not respond to the core treatments. The investigators are now learning that the~     underlying pathophysiology of disease is different among patients with asthma therefore;~     treatments which are beneficial in some patient groups may be not achieve affect in other~     groups.~      Antihistamines have been studied in the past for the treatment of asthma. These studies have~     shown that there may be a beneficial effect of antihistamines in patients with allergic~     asthma where histamine likely plays a large role in disease and treatment response. However,~     there is not enough evidence to include these drugs in the standard treatment of asthma.~      The investigators hypothesize that histamine plays a definable, significant role in disease~     pathogenesis and treatment response in children with allergic asthma. The investigators plan~     to test this overall hypothesis through two specific aims. The first aim will characterize~     the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be~     accomplished by comparison of the microvasculature response to histamine in children with~     allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis~     with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences~     in the pharmacodynamic response to histamine. The investigators will also investigate the~     role of genetic variation in the observed differences in HILD between the two groups. The~     second aim will characterize the pharmacodynamic response to antihistamines via HILD in~     children with an exaggerated histamine response compared to children with a low histamine~     response. This aim will be accomplished through conduct of a randomized, double-blind,~     placebo-controlled cross-over trial of levocetirizine (LCT) in the two groups (high histamine~     and low histamine) and observing the difference in antihistamine pharmacodynamics in the two~     groups. The investigators will also investigate the effect of pharmacokinetic variation and~     genetic variation in the histamine pathway on the observed pharmacodynamic drug response.~   "
166007|NCT01392846|"~     This is a prospective, observational, cohort study to evaluate the relative efficacy and~     safety of Resolute Integrity stent compared to other (drug eluting stents) DES.~   "
166008|NCT01392833|"~     Some years ago the investigators designed a randomised trial to prospectively evaluate~     whether adding low-dose azathioprine (1.5 mg/kg/day for six months) to steroids~     (methylprednisolone 1 g i.v. for three consecutive days at months 1, 3 and 5, plus oral~     prednisone 0.5 mg/kg every other day for six months) can improve long-term renal survival in~     adult IgAN patients with proteinuria higher than 1g/24 hours and plasma creatinine <=2.0~     mg/dl.~      In order to test the efficacy of the combination of steroids with azathioprine at various~     degree of renal function deterioration by extending the trial to patients with more advanced~     disease (serum creatinine higher or equal to 2 mg/dl) without any time limit for renal~     biopsy. Treatment will last one year: methylprednisolone 1 g i.v. for three consecutive days~     at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day~     for six months, then 0.2 mg/kg every other day for further 6 months. The primary outcome was~     renal survival (a 50% increase in plasma creatinine from baseline); the secondary outcomes~     were proteinuria over time and the number and types of adverse events in the two groups~     assessed every month for the first six months, every two months from the 6th to the 12th~     month and every three months thereafter. The planned duration of follow up is five years.~   "
166009|NCT01392820|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214~     in elderly healthy Japanese volunteers.~   "
166010|NCT01392807|"~     The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with~     impaired hepatic function versus subjects with normal hepatic function.~   "
166011|NCT01392794|"~     A study to compare time-course changes of plasma concentration of YM060 after intake of~     conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be~     administered without water.~   "
166012|NCT01392781|"~     Polycystic ovary syndrome (PCOS) is the most common endocrine disorder and cause of~     anovulatory infertility among reproductive aged women. According to the revised criteria of~     2003, four distinct phenotypes of PCOS can be diagnosed. However, there are emerging evidence~     supporting the existence of different levels of cardiometabolic risk between the four~     phenotypic groups of the syndrome. The purpose of this study is to determine the~     cardiovascular risk of i) normoweight and ii)overweight plus obese women of every one of the~     four phenotypes of the syndrome as well as the levels of low inflammation serum markers and~     the possible correlations of the between the outcomes.~   "
166013|NCT01392768|"~     The purpose of this study is to determine whether levetiracetam as adjunctive therapy is~     effective in the treatment of partial seizures, with or without secondary generalization,~     associated with refractory focal epilepsy.~   "
166014|NCT01392755|"~     This randomized, open-label study will evaluate the effect of food, and the effect of~     omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be~     assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of~     danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of~     omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.~   "
166022|NCT01392651|"~     Women with urinary stress incontinence who underwent surgical treatment by either TVTO or~     TVTS will be enrolled. The investigators will collect data from charts and use a telephone~     questionnaire to check the outcome of these women. Physical examination findings will also be~     incorporated.~   "
166023|NCT01392638|"~     Sildenafil citrate slightly reduces blood pressure in treated hypertensives patients.~     However, it is unknown if the simultaneous use of sildenafil plus, at least, 3 classes of~     antihypertensive agents in patients with resistant arterial hypertension may have a synergic~     effect on the patients blood pressure. Moreover, sildenafil improves the endogen nitric oxide~     effects. The nitric oxide is an important signaling molecule in the body that contributes to~     vessel homeostasis by inhibiting vascular smooth muscle contraction and growth. Hypertension~     often impaired NO pathways. Nitric oxide is produced by an enzyme, called nitric oxide~     synthase (NOS3), that show some genetics variants, which means that this enzyme can be~     different from person to person. Therefore, the objective of the present study is to examine~     the influence of a genetic variant (known to affect NOS3 levels) in sildenafil acute effects~     on hemodynamic and cardiovascular function. The investigators hypothesis is that individuals~     with the genetic variant associated to higher levels of NOS3 will have more benefits from~     sildenafil treatment.~   "
166024|NCT01392625|"~     The technique of transplanting progenitor cells into a region of damaged myocardium, termed~     cellular cardiomyoplasty1, is a potentially new therapeutic modality designed to replace or~     repair necrotic, scarred, or dysfunctional myocardium2-4. Ideally, graft cells should be~     readily available, easy to culture to ensure adequate quantities for transplantation, and~     able to survive in host myocardium; often a hostile environment of limited blood supply and~     immunorejection. Whether effective cellular regenerative strategies require that administered~     cells differentiate into adult cardiomyocytes and couple electromechanically with the~     surrounding myocardium is increasingly controversial and recent evidence suggests that this~     may not be required for effective cardiac repair. Most importantly, transplantation of graft~     cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a~     number of candidate cells have been transplanted in experimental models, including fetal and~     neonatal cardiomyocytes5, embryonic stem cell-derived myocytes6, 7, tissue engineered~     contractile grafts8, skeletal myoblasts9, several cell types derived from adult bone~     marrow10-15, and cardiac precursors residing within the heart itself16. There has been~     substantial clinical development in the use of whole bone marrow and skeletal myoblast~     preparations in studies enrolling both post-infarction patients, and patients with chronic~     ischemic left ventricular dysfunction and heart failure. The effects of bone-marrow derived~     mesenchymal stem cells (MSCs) have also been studied clinically.~      Currently, bone marrow or bone marrow-derived cells represent highly promising modality for~     cardiac repair. The totality of evidence from trials investigating autologous whole bone~     marrow infusions into patients following myocardial infarction supports the safety of this~     approach. In terms of efficacy, increases in ejection fraction are reported in the majority~     of the trials.~      Non-ischemic dilated cardiomyopathy is a common and problematic condition; definitive therapy~     in the form of heart transplantation is available to only a tiny minority of eligible~     patients. Cellular cardiomyoplasty for chronic heart failure has been studied less than for~     acute MI, but represents a potentially important alternative for this disease.~   "
166025|NCT01392612|"~     We hypothesized that the effect of erythropoietin may be reflected by changes in thromboxane~     B2 (TXB2) and endothelial cell function.~      Six male and six female subjects received recombinant human epoetin alpha (Erypo®)~     intravenously (300 Units per kg). Biomarker levels were assessed at baseline and 4, 24, 48~     and 72 hours after administration.~   "
166026|NCT01392599|"~     The purpose of this study is to investigated and evaluated the effectiveness of a new~     surgical technique for the treatment of severe chronic pain stages (Complex Regional Pain~     Syndrome Type II).~   "
166027|NCT01392586|"~     SUBMIT is a clinical trial that intends to answer the question whether up front breast~     surgery in patients with primary distant metastatic breast cancer will result in an~     improvement of the 2-year survival compared to the survival achieved with systemic therapy~     and delayed local treatment or systemic therapy alone.~      Randomization will take place immediately after the diagnosis of primary distant metastatic~     breast cancer. Patients either randomize for up front surgery of the breast tumor (UFS)~     followed by systemic therapy or for systemic therapy (ST) potentially followed by delayed~     local treatment of the breast tumor.~      The primary endpoint of this trial is the 2-years survival. Quality of life is one of the~     most important secondary endpoints.~   "
166028|NCT01392573|"~     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of~     this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira)~     and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their~     pre-trial treatment with metformin throughout the entire trial.~   "
166029|NCT01392560|"~     This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular~     filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects~     with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the~     safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.~   "
166030|NCT01392547|"~     This trial is conducted globally. The purpose of this trial is to confirm the efficacy and~     safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.~   "
166031|NCT01392534|"~     One of the most common adverse effects resulting from the therapy with thiazides,~     thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of~     plasma potassium may be a life-threatening condition due to increased risk of arrythmias.~     Moreover, it has been postulated that decrease in plasma potassium level may negatively~     affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The~     main goal of this study is to assess the efficacy and safety of~     telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the~     effects of the therapy on plasma potassium level and also on selected parameters of glucose~     and lipid metabolism.~   "
166032|NCT01392521|"~     The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated~     protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent~     treatments in other phase I studies. This study will test the combination of these two drugs~     to try and answer the following questions:~        1. What are the side effects of the combination of Copanlisib and Refametinib~          (BAY86-9766)when given together at different/increasing dose levels?~        2. What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future~          clinical research studies?~        3. How much Copanlisib is in the blood at specific times after administration and does~          adding Refametinib (BAY86-9766) have an affect?~        4. How much Refametinib (BAY86-9766) is in the blood at specific times after administration~          and does adding Copanlisib have an affect?~        5. Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on~          tumors?~   "
166035|NCT01392482|"~     Multicentre, retrospective observational cohort study based on LHU administrative databases~     aimed to described the pharmacoutilization of antipsychotics in patients affected by~     schizophrenia and bipolar disorder, the resource consumption and medication adherence. A sub~     analysis will be performed for those patients switching from Quetiapine IR to Quetiapine XR~     and comparing the periods before and after the switch.~   "
166036|NCT01392469|"~     This study will investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan~     and sildenafil at steady state when co-administered to pulmonary arterial hypertension~     patients.~   "
166037|NCT01392456|"~     The aim of the study is:~        1. To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in~          Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by~          Allen and Locker for edentulous adults. The OHIP questionnaire is an efficient~          instrument for assessment of OHRQoL - Oral Health-Related Quality of Life.~        2. To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with~          implant-supported overdentures with three different types of retention: Retentive~          Anchors, Magnets, Locator.~   "
166038|NCT01392443|"~     The objective of this study is to determine the efficacy of INC424 as assessed by reduction~     in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV) MF,~     or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the~     effects of INC424 on patient reported outcomes and the duration of response as assessed by~     reduction in spleen volume will also be assessed.~   "
166039|NCT01392430|"~     The purpose of this study is to compare the incidence of opportunistic infections between~     HIV-infected patients who continue and discontinue primary or secondary prophylaxis for~     opportunistic infections in whom receiving combination antiretroviral therapy and achieve~     undetectable HIV-1 RNA, but CD4 cell counts are less than 200 cells/mm3.~   "
166040|NCT01392417|"~     Women who had surgery for pelvic floor prolapse underwent surgery by anterior Prolift or~     Posterior prolift at least a year after the surgery.~      The data from the charts and from telephone conversations with the patients will be entered~     to a database. Physical examination data will also be incorporated.~   "
166041|NCT01392391|"~     Chronic hemiparetic stroke is associated changes in body composition, skeletal muscle and~     cardiometabolic health; specific changes include paretic limb muscular atrophy, increased~     intramuscular fat deposition, elevated prevalence of impaired glucose tolerance and type 2~     diabetes. This randomized intervention study compares a 6 month task oriented exercise~     programs versus control with both groups receiving best medical stroke care according to~     American Stroke Association Get with the Guidelines. The hypothesis is that is 6 months of~     task-oriented exercise initiated early across the sub-acute period of stroke can prevent or~     ameliorate the natural course of these body composition, skeletal muscle and cardiometabolic~     health changes.~   "
166042|NCT01392378|"~     The purposes of this study are assess the immunological response (measure the amount of~     antibodies, i.e. proteins that fight off germs) produced by children after they have been~     given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months~     of age when medications to prevent fever are given on the same day as the vaccination. Also~     to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who~     receive medications to prevent fever on the day of vaccination.~   "
166043|NCT01392365|"~     The aim of this study is to develop a scoring system and a prediction model for differential~     diagnosis between intestinal tuberculosis and Crohn's disease.~   "
166044|NCT01392352|"~     Pazopanib is a new cancer drug that works by limiting the growth of new blood vessels in~     tumours. About half of patients who take pazopanib develop high blood pressure~     (hypertension). This side effect can make patients have to reduce or stop their cancer~     treatment, and can cause other health problems. The aim of this study is to find out exactly~     how the drug causes high blood pressure.~   "
166045|NCT01392339|"~     Obstructive sleep apnea is a multi-component disease. This study will test the hypotheses~     that hypoxia per se modulates gene expression in animal model of sleep apnea and these~     results may be translated with alterations that occur in apneic patients. Thus, we aim to~     integrate basic and clinical research to shed light on novel candidate genes involved in~     sleep apnea.~   "
166046|NCT01392326|"~     This study will assess the efficacy and safety of secukinumab in patients with active~     psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs,~     DMARDs and / or TNFα inhibitor therapy.~   "
166047|NCT01392313|"~     The investigators will measure renal function in subjects ingesting carnitine to determine if~     the product alters renal function.~   "
166048|NCT01392300|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of the upper limb are effective in treating spasticity in patients after stroke.~   "
166049|NCT01392287|"~     This study involves collaboration between McLean Hospital, Geriatric Medicine at the~     Cambridge Health Alliance (CHA) and other sites within the Partners and Harvard Medical~     School network. The investigators plan to recruit individuals 55 to 89 years old with~     treatment resistant depression. Someone with treatment resistant depression for this study~     may be someone who still has sad or low feelings and thoughts even though he/she is taking an~     antidepressant medication for at least 8 weeks to help relieve his/her depression. During the~     study, subjects will gradually add memantine hydrochloride in dosages up to 20 mg/day for 8~     weeks to their standard antidepressant treatment.~      The investigators are doing this research study to help answer 3 questions:~        1. Do older adults with treatment resistant Major Depression have lower levels of a~          chemical in the brain called NAAG than older adults without Major Depression?~        2. Do older adults with naturally low NAAG levels do better on memantine hydrochloride~          treatment than older adults with higher amounts of this chemical on memantine~          hydrochloride treatment?~        3. Do older adults with treatment resistant depression have more problems with memory and~          concentration than older adults without depression?~      The investigators are also interested in looking at electrical and neuronal activity of the~     brain, spiritual beliefs, and fatigue in relationship to depression.~      The investigators hypothesize that:~        1. Older individuals with treatment resistant Major Depression will have lower levels of~          NAAG compared with age-matched older control subjects.~        2. Older adults with treatment resistant depression and low NAAG levels will do better on~          treatment with memantine hydrochloride than older adults on memantine with higher NAAG~          levels.~        3. Older adults with depression will do better on tests of attention and executive~          functioning after treatment with memantine hydrochloride.~        4. Healthy controls will do better on tests of attention and executive functioning than~          older adults with depression.~   "
166050|NCT01392274|"~     This study will collect data from patients undergoing an ERCP procedure with probe-based~     Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate~     the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when~     associated with other diagnostic information (standard ERCP and tissue sampling).~   "
167865|NCT01368406|"~     The aims of this study were to evaluate the efficacy of an intervention for weight gain~     management for patients from schizophrenia spectrum compared to treatment as usual (TAU), and~     to evaluate the effects of this program on metabolic profile, symptoms and quality of life.~   "
166051|NCT01392248|"~     1. Rationale The inter-individual pain experience immediately after surgery is~          considerable. In addition, a number of patients develop chronic post surgery pain~          (CPSP). Patients undergoing surgery for breast cancer are at risk of developing both~          acute post surgical pain as well as CPSP. Recently, in a group of patients with chronic~          back pain, it was demonstrated how subjectively reported pain is associated with~          specific electroencephalography (EEG) parameters, namely the N2 and P3 components of the~          pain event-related potential (ERP). It was concluded that ERP was associated with~          self-reported pain in daily life up to two weeks after the measurement. This resulted in~          the current hypothesis that EEG may be a predictor for postoperative pain.~        2. Study design Prospective cohort study. Within 2 weeks before surgery, 150 patients will~          undergo an EEG measurement with five 'vulnerability' tasks. The experiment will be~          repeated 6 months postoperatively.~           Study population: Female patients with breast cancer who will undergo breast surgery,~          between the ages of 18 to 65 years.~        3. Main study parameters/endpoints Primary outcome is postoperative pain, measured in a~          pain diary 4 days postoperatively. Secondary outcomes are development of chronic post~          surgery pain and quality of life. The main goal is to develop a comprehensive prediction~          model for acute and chronic postoperative pain after breast cancer surgery, based on the~          EEG results of the five vulnerability experiments.~   "
166052|NCT01392235|"~     RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3,~     Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.~      PURPOSE: This phase II trial is studying how well famitinib works in treating patients with~     recurrent and/or metastatic NPC.~   "
166053|NCT01392222|"~     The purpose of this study is to understand more about why some patients choose to have~     surgery to treat their papillary microcarcinoma (PMC) and others choose to have their~     papillary microcarcinoma (PMC) regularly watched by their doctor to see if and when they may~     need surgery (referred to as active surveillance). The investigators also hope learn more~     about what patients and their family members worry about or feel they will gain from surgery~     or active surveillance.~   "
166054|NCT01392209|"~     The best dose of radiation to be given with bevacizumab is currently unknown. This study will~     use higher doses of radiation with bevacizumab than have been used before. This study will~     test the safety of radiation given at different doses with bevacizumab to find out what~     effects, good and/or bad, it has on the patient and the malignant glioma or related brain~     cancers.~   "
166055|NCT01392196|"~     This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary~     aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe~     and determine the evidence of a response to renal denervation in patients with Heart Failure.~   "
166056|NCT01392183|"~     The goal of this clinical research study is to compare pazopanib to temsirolimus in the~     treatment of advanced clear-cell renal cell carcinoma. The safety of each drug will also be~     studied.~      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for~     tumor growth. This may prevent or slow the growth of cancer cells.~      Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to~     die.~      This is an investigational study. Pazopanib and temsirolimus are both FDA approved and~     commercially available for the treatment of kidney cancer. It is investigational to compare~     the 2 drugs.~      Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.~   "
166057|NCT01392170|"~     The goal of this clinical research study is to learn if adding pegylated interferon-alfa 2a~     (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of~     this treatment combination will also be studied.~      Pegasys is a form of the drug interferon. It is designed to help the body's immune system to~     fight infections. It may also affect the body's response to cancer.~      A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a~     protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from~     growing, and may cause them to die.~      You are already receiving a TKI. This consent form will describe the administration of~     Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys,~     and any risks/benefits there may be from receiving Pegasys.~   "
166058|NCT01392157|"~     The main side-effect of Implanon is the changes induces in bleeding patterns including~     amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without any~     previous symptom and it was characterized as breakthrough bleeding (BTB). BTB is the main~     causes of early discontinuations. Unfortunately, there is no indication to predict prior to~     insertion what sort of bleeding pattern any individual woman may have after insertion and the~     proposed treatments were disappointed. Nevertheless, previous studies with other~     progestin-only contraceptives (including Implanon) provide evidence that the provision of~     adequate and intensive counseling to potential users and new acceptors about bleeding changes~     can help to improve method continuation.~      The availability of Implanon in the public sector could help in the development of strategies~     to introduce the method in the public sector network and the training of medical residents.~   "
166059|NCT01392144|"~     The goal of this clinical research study is to learn if the level of nitric oxide you breathe~     out may relate to the amount of breathing complications that you may experience due to~     radiation treatment.~   "
166060|NCT01392131|"~     Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma~   "
166061|NCT01392118|"~     The purpose of this study is to investigate the risk factor, molecular character and~     susceptibility change for recurrent ESBL-producing Enterobacteriaceae bacteremia~   "
166105|NCT01391546|"~     PRIMARY OBJECTIVES~      Two co-primary objectives are:~        -  To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route~          (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC)~        -  To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of~          varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination~      SECONDARY OBJECTIVES~      Immunogenicity objectives~        -  To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following~          ZOSTAVAX administered by IM or SC route~        -  To evaluate the immune response as measured by a second assay, the VZV Interferon gamma~          Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or~          SC route~      Safety objective~      - To describe the safety profile of ZOSTAVAX administered by IM or SC route~   "
166062|NCT01392105|"~     Early reperfusion strategies in tandem with remarkable advances in drugs and devices for~     treating myocardial infarction (MI) have contributed to a reduction in early mortality, but~     cardiovascular disease remains the leading cause of death worldwide. Current management~     strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart~     failure. In this respect, stem-cell therapy has shown potential benefits for repairing the~     damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive~     therapeutic candidates because of their high capacity for replication: paracrine effect:~     ability to preserve potency: and because they do not cause adverse reactions to allogeneic~     versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but~     only one clinical trial using MSCs via the intracoronary route in the setting of acute~     myocardial infarction (AMI) has been carried out. The investigators therefore assessed the~     safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in~     patients with AMI.~   "
166063|NCT01392092|"~     N-acetylcysteine (NAC) is a medication that the Food and Drug Administration (FDA) has~     approved for several medical uses, such as dissolving mucus in patients with breathing~     problems, treating overdose from acetaminophen (Tylenol), and protecting the kidneys from~     toxic substances.~      Some recent studies suggest that NAC could be useful in the treatment of other disorders~     including addictions. One purpose of this study is to determine whether NAC alters the level~     of brain glutamate (a chemical that excites brain cells). The other main purpose is to~     determine whether NAC affects how much cocaine people use.~   "
166064|NCT01392079|"~     Aims and objectives~        -  Assessment of the efficacy of the study treatment in the study population in terms of~          response rate, progression-free survival, failure-free survival and overall survival.~        -  Acquisition of further data to expand the data base on the toxicity of the study~          treatment.~        -  Assessment of the efficacy of the study treatment in biological risk groups.~        -  Assessment of response in terms of minimal residual disease. Number of patients and~          estimated duration Total no. of patients: 122 (~29 with 17p deletion for first-line~          therapy, ~29 with 17p deletion for second- or higher-line treatment, ~65~          fludarabine-refractory irrespective of 17p status).~      Duration for each patient: Max. 12 weeks of treatment in three 4-week cycles, then up to two~     years maintenance treatment.~   "
166065|NCT01392066|"~     The purpose of this study is to describe psychosocial adjustment in patients with breast~     cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study~     mutual influences of the partner on the patient and vice versa, and to identify risk and~     protective factors that influence the adjustment process in both patients and partners. The~     overall aim is to generate knowledge that helps enables us to integrate the partners' needs,~     problems and resources in treatment and rehabilitation of breast cancer patients.~   "
166066|NCT01392053|"~     The objective of this research is to evaluate the effect of massage therapy as a resource for~     pain relief during the active phase of labor. The research will be of type randomized~     controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral~     Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups~     (lumbosacral massage) and control (routine maternity) and will be assessed before and after~     therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation~     will be performed by numerical category scale, Diagram Location of Pain and Pain~     Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction~     questionnaire.~   "
166067|NCT01392040|"~     The purpose of this study is to determine whether the new algorithm is safety and effective~     in proposing the dosage and the timing of oral anticoagulant therapy.~   "
166068|NCT01392027|"~     This proposed project is designed to collect data and specimens from patients/subjects~     presenting to the University of Michigan with a disease affecting the pancreas (or specific~     control populations). This protocol is focused on collecting data, blood samples, and tissue~     on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts,~     pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy~     controls.~      We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy~     coat are collected and stored according to strict SOPs.~   "
166069|NCT01392014|"~     Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping~     malaria transmission.The addition of primaquine (PQ) - the only drug commercially available~     that kills mature transmission stage - to such treatments might be necessary to eliminate~     this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine~     (DHP) regimens with or without PQ on the sexual and asexual stages of P. falciparum in~     Sumatra, Indonesia.~   "
166070|NCT01392001|"~     This observational study will evaluate the glucocorticoid sparing effect after 12 months of~     treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data~     will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from~     patients who had been on treatment with >5 mg prednisone or equivalent for at least 3 months~     .~   "
166071|NCT01391988|"~     Prospective trial comparing post-operative complications and seroma formation after~     mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic~     scalpel.~   "
166072|NCT01391975|"~     Newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of the~     blood vessels. Methods of detecting narrowing are available and, more importantly, can detect~     narrowings before a fistula fails. It is not known whether treating these narrowings will~     actually improve fistula survival or if the majority can be left alone. we wish to see if we~     can detect such narrowings with ultrasound scanning and if early detection and treatment~     improves patient outcomes.~   "
166115|NCT01391416|"~     It is well recognized that patients with chronic kidney disease (CKD) have an increased risk~     for cardiovascular disease (CVD) and hyperhomocysteinemia appears to be a predictor of future~     CVD events. Hyperhomocysteinemia has been reported to bo of high prevalence in patients with~     CKD. The investigators aim to study the prevalence of hyperhomocysteinemia in Thai CKD~     patients by using Thai Screening and Early Evaluation of Kidney Disease (SEEK) study database~     and their relationship to CVD.~   "
166116|NCT01391403|"~     This study will determine the effectiveness of artemisinin plus risperidone in improving~     symptoms and cognitive disturbances and in Chinese people with schizophrenia. The study~     addresses the Toxoplasma infection hypothesis of schizophrenia.~   "
166073|NCT01391962|"~     Background:~        -  Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less~          than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients~          with metastatic ASPS. Little is known with regards to relevant molecular markers as~          potential therapeutic targets.~        -  Cediranib (AZD2171) and sunitinib (SU011248), oral small molecule inhibitors of VEGF~          receptor tyrosine kinases, are showing preliminary evidence of activity in patients with~          ASPS.~      Objectives:~        -  Part I: Determine the objective response rate (ORR) of single-agent cediranib and~          single-agent sunitinib malate in patients with advanced ASPS.~        -  Part II: Determine the ORR of cediranib in patients who progress on the sunitinib arm,~          and determine the ORR of sunitinib in patients who progress on the cediranib arm.~        -  Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and~      single-agent sunitinib malate in patients with advanced ASPS.~      Eligibility:~        -  Patients aged greater than or equal to 16 years with histologically or cytologically~          confirmed metastatic ASPS.~        -  Patients must show evidence of objective disease progression per RECIST 1 on scans~          within the 3-month period immediately preceding enrollment. Both scans used to determine~          disease progression should have been obtained within this 6-month period.~        -  Patients with newly diagnosed, unresectable, measurable, metastatic ASPS who show~          clinical evidence of disease progression will be eligible.~        -  Patients must not have received treatment with any VEGF receptor tyrosine kinase~          inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment~          with bevacizumab is allowed.~      Design:~        -  Part I: Patients will be randomized to receive cediranib (30 mg) or sunitinib malate~          (37.5 mg) orally, once a day in 28-day cycles.~        -  Part II: At the time of disease progression, patients will cross over to the other~          treatment arm after a 2-week wash-out period.~        -  Appropriate anatomic imaging studies will be performed at baseline and every 2 cycles~          for restaging.~        -  The study will be conducted using an optimal two-stage design to rule out an~          unacceptably low 15% clinical response rate (PR+CR) in favor of a modestly high response~          rate of 40%.~      The study will initially enroll 10 evaluable patients in each arm. If 0 or 1 of the 10~     patients has a clinical response, then no further patients will be accrued. If 2 or more the~     first 10 patients have a response, then accrual continues to a total of 22 patients in each~     arm.~   "
166074|NCT01391949|"~     This purpose of this study is to determine the effect of different levels of feedback on~     participation in a home exercise regimen and the amount of walking performed by patients~     recently discharged from the acute rehabilitation setting.~   "
166075|NCT01391936|"~     Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon~     fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence~     regarding the optimal treatment and outcome of these fractures with only one prospective~     randomized trial (1992) in the literature comparing tension band wire and plate fixation for~     displaced olecranon fracture. Our trial includes all patients under the age of 75yrs~     presenting to the Edinburgh Orthopaedic Trauma Unit with an isolated olecranon fracture~     requiring operative intervention. Patients who consent to enrol in the trial will be~     randomised to operative fixation using one of two recognised fixation techniques - tension~     band wire fixation or plate fixation. Patients will be evaluated over a one year period~     following their surgery.~   "
166076|NCT01391923|"~     This study is being performed to reduce unwanted fat in the arm using a new applicator for~     the Zeltiq System.~   "
166077|NCT01391910|"~     The aims of the study are: 1)to assess pre and post-operative Quality of Life (QOL) as~     measured by the Sino-Nasal Outcomes Test(SNOT)-20 questionnaire and 2)determine the~     significance of response shift on treatment effect.~      This is a prospective cohort study. The investigators will recruit patients who are within a~     6 month post-functional endoscopic sinus surgery (FESS) timeframe and completed a~     pre-operative SNOT-20. The investigators will ask subjects to complete two more SNOT-20 forms~     and a Transition Quality of Life (QOL) scale. The SNOT-20 forms will be labelled pre and~     post operative. The pre should be completed based on subject's memory of their condition~     prior to surgery and post based on how they feel now.~   "
166078|NCT01391897|"~     This reported observational clinical study aims at identifying epigenetic markers in a sample~     of patients undergoing high dose inpatient psychotherapy suffering from a variety of~     psychiatric/psychosomatic diseases such as somatoform disorders, posttraumatic stress~     disorder (PTSD), depression, anxiety disorders and eating disorders.~      The exact epigenetic markers that will be traced are yet to define.~      The investigators believe that~        1. Epigenetic patterns found in the group of psychiatric patients show differences from~          healthy controls~        2. Different diagnosis show differences in epigenetic patterns as well~        3. Epigenetic patterns correlate to the severity of the psychosocial disorder as measured~          in interviews or psychometric ratings~        4. Epigenetic patterns can change under inpatient high dose psychotherapy~        5. Changes correlate to clinical psychometric variables.~   "
166079|NCT01391884|"~     The prevalence of type 2 diabetes (T2D) is increasing rapidly worldwide. T2D is characterized~     by a severely impaired incretin effect. The incretin effect refers to the insulinotropic~     action of the nutrient-released incretin hormones glucagon-like peptide-1 (GLP-1) and~     glucose-dependent insulinotropic peptide (GIP). The incretin effect is defined as the~     difference in insulin secretory responses between oral and isoglycaemic intravenous glucose~     challenges (OGTT and IIGI, respectively) and in healthy individuals it accounts for as much~     as 70% of the insulin response following oral glucose, whereas patients with T2D exhibit an~     incretin effect in the range of 0 to 30%. Patients with T2D and non-diabetic patients with~     severe kidney failure share several pathophysiological characteristics, including decreased~     insulin sensitivity, fasting hyperinsulinaemia and impaired beta-cell function. The reason~     for these findings remains to be fully elucidated. An ongoing study in our research group is~     investigating the incretin effect and the incretin hormone secretory responses following~     OGTT, IIGI and meal ingestion, respectively. In continuation of this study, essential~     knowledge of metabolism of incretin hormones in an uremic milieu will be obtained in the~     present study prior to evaluation of the use of incretin-based agents in patients with~     impaired kidney function. In this second study we evaluate the elimination and biodegradation~     of GLP-1 and GIP. The biological active incretin hormones are rapidly degraded by the~     ubiquitous enzyme dipeptidyl peptidase-4 (DPP-4), generating inactive metabolites. The active~     hormones are however also eliminated by renal clearance, although the importance of this~     remains questionable. It is likely that the degradation and elimination of the active~     hormones will be significantly affected in patients with severe kidney impairment.~      We hypothesize that elimination and biodegradation of the two incretin hormones, both in it´s~     active and inactive forms, will be affected in non-diabetic patients with severe kidney~     failure.~   "
166080|NCT01391871|"~     The purpose of this study is to compare vascular healing of the stented segment after~     deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting~     stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.~   "
166106|NCT01391533|"~     Primary Objectives:~      To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of~     SAR125844 when administered as single agent at the MTD.~      To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene~     amplified solid tumors (including sub-group of MET-amplified non-small cell lung cancer~     [NSCLC] patients) and in patients with Phospho-MET positive tumors without MET-gene~     amplification.~      Secondary Objectives:~      To characterize the global safety profile including cumulative toxicities. To evaluate the~     pharmacokinetic profile of SAR125844 in the proposed dosing schedule(s).~      To assess preliminary antitumor activity in patients with measurable/evaluable disease,~     according to RECIST 1.1 criteria.~      To explore the pharmacodynamic effects (PD) of SAR125844. To explore MET gene amplification~     status in Circulating Tumoral Cells (CTCs) and on tumor biopsies collected during the study,~     in the escalation part only.~      To evaluate other pharmacodynamic biomarkers and help selection of patients who could benefit~     from SAR125844.~      To explore MET-gene amplification status in circulating DNA.~   "
166081|NCT01391858|"~     This study will compare the effects of oral pregabalin with placebo on postoperative pain and~     morphine usage after mastectomy.~      Pregabalin is an anticonvulsant agent approved by the United States Food and Drug~     Administration (FDA) for the treatment of neuropathic pain associated with post-herpetic~     neuralgia and diabetic neuropathy.~      Women 18-70 years of age, undergoing unilateral modified mastectomy or lumpectomy with~     axillary node dissection will be recruited to participate in the study. Patients unable to~     cooperative, those that have known allergy to pregabalin or morphine and a history of drug or~     alcohol abuse, chronic pain, history of daily intake of analgesics or steroids, or impaired~     kidney function will all be excluded from the study. A pregnancy test will also be performed~     to exclude pregnant women from the study.~      Oral pregabalin 300 mg (or placebo) will be administered to patients 1-2 hours before surgery~     followed by 150 mg 12 hours later. Thereafter, 150 mg of oral pregabalin (or placebo) will be~     administered twice daily until day 14. Whether a patient receives pregabalin or placebo will~     be decided based on a process similar to tossing a coin.~      Patients will receive a standard general anesthetic for their operation and will receive~     intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate~     postoperative period. Oral opioids will be administered after discontinuation of the PCA.~      Subjects will be visited after the operation while in the hospital and intermittently for~     three months at the outpatient clinic after discharge from the hospital. Subjects will be~     asked to return remaining study drug/empty container when they are at the hospital for their~     2 week follow up visit.~      Potential adverse effects of pregabalin include dizziness, somnolence, peripheral edema,~     weight gain, headache, dry mouth, blurry vision, and ataxia. The incidence of these side~     effects occurring ranges variously between 1 and 25%. Investigators will closely monitor all~     patients for the occurrence of these side effects.~   "
166082|NCT01391845|"~     Controlled ovarian stimulation (COS) for FIV increases progesterone (P) and estradiol (E2)~     serum levels in supraphysiologic concentrations at the end of follicular phase. Elevated~     serum P levels leads to an accelerated endometrial maturation which interferes with the~     dialogue between embryo and endometrium. It has been reported that serum progesterone levels~     ≥ 1.5 ng/ml on the last day of COS are related to a significant decrease in the ongoing~     pregnancy rate following IVF cycles. Also, it has been reported a significant alteration in~     the endometrial gene expression profile related to P elevated levels.~      Glycodelin-A is an immunomodulatory glycoprotein synthesized by luteal-phase endometrial~     epithelium and its expression seems to be related to the action of P. Because glycodelin-A~     has immunosuppressive activity, it may facilitate the process of implantation and the~     maintenance of pregnancy.~      It is already know that ulipristal acetate (UPA) decrease serum P levels. The hypothesis of~     this study is that UPA is been able to modify P serum levels and glycodelin-A endometrial~     expression pattern on FSH/GnRH Antagonist cycles for FIV.~   "
166083|NCT01391832|"~     The objective will be to determine if adding repetitive transcranial magnetic stimulation~     prior to Cognitive Processing Therapy significantly enhances recovery from hyperarousal~     symptoms in individuals with combat related post traumatic stress disorder and improves~     clinical outcome.~      The investigators have assembled a multimodal human performance laboratory including 64~     channel EEG and repetitive transcranial magnetic stimulation system. These resources combined~     with the neuroimaging capabilities of the Advanced Imaging Research Center (AIRC) at UT~     Southwestern and skilled Cognitive Processing Therapy (CPT) practitioners will be used in~     this study.~      The study involves approximately 19 visits. Treatment is once a week for 12 weeks followed by~     a 1 month, 3 month and 6 month follow-up appointments.~   "
166084|NCT01391819|"~     The aim of this study is to establish an active surveillance in order to generate dengue~     disease burden estimates including incidence rates, prevalence data, clinical presentation~     and cost of illness in Forteleza (Brazil).~   "
166085|NCT01391806|"~     The purpose of this prospective observational study is to evaluate the impact of preoperative~     breast MRI in patients with breast cancer selected for breast- conserving surgery. MRI is a~     more sensitive radiological modality than mammography and ultrasonography. Patients with~     small breast cancers are, based on conventional modalities, selected for breast-conserving~     surgery. If preoperative breast MRI reveal additional lesions in the breasts, and malignancy~     is confirmed histopathologically, this finding leads to a change of surgical method to~     mastectomy.~   "
166086|NCT01391793|"~     In this study the investigators will determine whether corticosteroids given at the time of~     urinary tract infection help prevent permanent damage to the kidneys.~   "
166087|NCT01391780|"~     Aims: To assess pelvic floor muscle (PFM) strength in women with stress urinary incontinence~     (SUI) and urgency urinary incontinence (UUI).~      Methods: 51 women were prospectively divided into two groups, according to the symptoms as~     SUI (G1 = 22) or UUI (G2 = 29). Demographic data, such as number of Pads/ 24 hours, number of~     micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for~     which an urgent void could be voluntarily postponed), number of parity and vaginal deliveries~     were obtained using a clinical questionnaire. Objective urine loss was evaluated by 60-min~     Pad Test. Subjective [urine stream interruption test (UST), visual survey of perineal~     contraction and transvaginal digital palpation] and objective (vaginal manometry) evaluations~     of PFM were performed in all patients.~   "
166088|NCT01391767|"~     This study histologically evaluates sites grafted with NuOss XC using ridge preservation~     techniques prior to placement of dental implants. Sites grafted with NuOss XC (bovine bone~     mineral with self-expanding collagen) will be compared to sites grafted with NuOss~     particulate (bovine bone mineral).~   "
166089|NCT01391754|"~     The study is a field trial comparing the SafeCare family preservation model to a comparable~     usual care model for parents in child welfare. The study also compares two levels of service~     quality control.~   "
166090|NCT01391741|"~     People with disease (PD) tend to walk with short steps, decreased velocity, and increased~     stride time variability. Short steps and increased variability are related to greater fall~     risk. In addition, concurrent performance of a cognitive task (dual-task (DT)) has marked~     effects on gait in people with PD which is considered to reflect an impaired automaticity of~     gait.~      Objective: To investigate short and long term effects of high-volume walking with visual~     spatial cues (VSC) on gait variables, automaticity, and functional mobility, in people with~     Parkinson´s Disease (PD), compared with walking without VSC.~   "
166107|NCT01391520|"~     This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron~     chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney~     Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who are~     undergoing diagnostic or interventional coronary angiography will be randomized to either~     placebo or CRMD001 and followed for 90 days. Subjects will receive 8 days of randomized~     therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be~     the difference in a composite of specified renal and cardiovascular clinical events occurring~     through Day 90.~   "
166091|NCT01391728|"~     The purpose of the project is to formulate, implement and evaluate a new type of~     activity-orientated, evidence-based prevention programme to prevent fall injuries among~     elderly people. The question examined by the study is whether the intervention programme can:~        -  significantly reduce accidents and incidents involving falling among the participants,~        -  influence variables such as satisfaction with life, confidence in one's own ability and~          a feeling of involvement,~        -  be shown to be cost effective in terms of the use of resources. The intervention~          programme - Active lifestyle all your life - is being developed in and for primary care~          for the cost effective prevention of fall injuries among elderly people using a method~          that results in continued active life. The aim is to ensure that the elderly person is~          able to continue living an active life with commitment and involvement, which can in~          itself prevent fall injuries. This presupposes a knowledge of how to avoid fall injuries~          and the measures and aids that are available to prevent such injuries. The programme~          will also provide the participants with a social community in self-supporting groups~          which, by their own efforts but also with social support, are able to continue some of~          the activities provided through primary care.~   "
166092|NCT01391715|"~     To the best of our knowledge, there has been no randomized controlled trial to compare double~     dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize~     that a double dose PPI would accelerate and sustain the control of symptom in NERD patients.~   "
166093|NCT01391702|"~     When a woman requires a cesarean section after labour, anesthesia is usually provided by a~     pre-existing epidural. Occasionally, the epidural does not work. The anesthesiologist then~     may give a spinal anesthetic. The spinal space is identified by seeing cerebrospinal fluid~     (CSF) in the spinal needle. Rarely a spinal fails after a failed epidural as the fluid seen~     is epidural space fluid, not CSF. This study plans to use a bedside glucose monitor to~     measure glucose (sugar) in epidural fluid (compared to CSF) allowing the anesthesiologist to~     know the spinal needle is in the correct space.~      The investigators hypothesize that a bedside glucose measurement device can accurately~     quantitate the level of glucose within epidural space aspirate, and therefore could aid~     differentiation between CSF and epidural fluid.~   "
166094|NCT01391689|"~     This phase II/III trial studies how well diindolylmethane (DIM) works and compares it to~     placebo in treating patients with breast cancer. DIM may slow the growth of tumor cells and~     be an effective treatment for breast cancer.~   "
166095|NCT01391676|"~     The aim of this study is imaging of trabeculectomy blebs regarding structure and function~     with the spectral domain optical coherence tomography.~   "
166096|NCT01391663|"~     The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of~     alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin in~     healthy Korean subjects.~   "
166097|NCT01391650|"~     The purpose of this prospective study is to evaluate the influence of both bundles on the~     knee stability - anterior-posterior translation, internal and external rotations after the~     double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability after~     single-bundle and double-bundle reconstruction using a computer navigation system.~   "
166098|NCT01391637|"~     The purpose of this study is to determine the long term safety and preliminary effect of~     HuCNS-SC cells transplanted in subjects with Connatal Pelizaeus-Merzbacher Disease (PMD).~   "
166099|NCT01391624|"~     The purpose of this study is to determine whether essential polyunsaturated acids (omega 3)~     are capable of reducing chocolate craving symptoms in healthy patients.~      Our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize~     neuronal functioning in many conditions, including chocolate craving.~   "
166100|NCT01391611|"~     This study is being done to gather information about the safety (any harmful effects) and~     effectiveness (usefulness) of Pazopanib in the treatment of Gastrointestinal Stroma Tumors~     (GIST) that cannot be treated by surgery or has spread to other organs. The Food and Drug~     Administration (FDA) have approved Pazopanib for the treatment of advanced kidney cancer but~     it is not approved for the treatment of GIST. The investigators hope to learn about the~     safety and usefulness (effectiveness) of Pazopanib for patients with GIST.~      Primary Objective:~      Non-progression rate based on RECIST criteria (CR+PR+SD)~      Secondary Objectives:~        -  Response per Choi criteria~        -  6 month progression-free survival~        -  Safety and tolerability~   "
166101|NCT01391598|"~     The study's primary objective is to evaluate the effect of intravenous lidocaine on pain and~     plasma interleukin-1 (IL-1), interleukin-6 (IL-6) and substance P in patients with~     fibromyalgia.~      As secondary objectives: evaluate the clinical manifestations, and plasma concentration of~     lidocaine.~   "
166102|NCT01391585|"~     The investigators are testing whether patients with diabetes can communicate with our health~     care system through text messaging. The investigators will look at how often they respond to~     prompts for blood pressures, blood sugars, and step counts. The investigators will also see~     if they come in for lab tests when prompted by text message. Also, for patients overdue for~     medication refills, the investigators will ask them why they have not yet called for the~     refill.~   "
166103|NCT01391572|"~     A randomized phase II trial to estimate the optimal radiation volume of postsurgical~     radiation for patients with locoregionally advanced thoracic esophageal squamous cell~     carcinoma (T3-4, any N, M0).~   "
166104|NCT01391559|"~     Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are~     uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One~     possible explanation is that the patient is unable to inhale the dry powder bronchodilator~     medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A~     PIFR < 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device.~     The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured~     at two hours after inhalation of the study medication will be higher with arformoterol~     solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from~     the Diskus.~   "
166108|NCT01391507|"~     The purpose of this study is to investigate the effect of COR-1 in combination with standard~     therapy in patients with heart failure. The safety and tolerability of COR-1 will also be~     assessed.~   "
169960|NCT01340924|"~     The overall objective of this research project is to study the impact of preventive practices~     on the T2D-related risk profile among women with and without prior GDM and their children~     exposed and unexposed to GDM.~   "
166109|NCT01391494|"~     Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth~     disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family~     Picornaviridae.~      Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in~     the Asia-Pacific region. Notably, there is evidence that the most severe cases from these~     epidemic outbreaks are associated with neurological disorders with CNS involvement caused by~     EV71 infection. Because of these EV71 infection-related public health issues, the research~     and development of EV71 vaccine candidates have been heavily promoted.~      Recently, several EV71 vaccine candidates have been evaluated in animals but no final results~     of clinical trials, including inactivated vaccine, attenuated vaccine, subunit vaccine, DNA~     vaccine, epitope peptide vaccine, virus-like particles (VLPs).~      Basing on the previous studies of elicited protection in mice and rhesus monkeys, a~     formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA~     in China, Dec. 2010. The phase I clinical trial has been carried out, during four months, in~     Guangxi Province, China. The purpose of this study is to evaluate the safety, tolerability~     and immunogenicity of the formalin-inactivated EV71 vaccine in Chinese adults (from 18 to 49~     years old), children (from 3 to 11 years old) and infants (from 6 to 35 months old).~   "
166110|NCT01391481|"~     PFCs (perfluorocarbons, PFC), an ideal liquid respiratory media, has special chemical and~     biological properties, including high solubility of gas, swiftness of carrying and release,~     low surface tension, high proportion, almost non-absorbing and non-metabolic characteristics~     in the body. On the basis of the strong animal data suggesting the efficacy of PFC vapor~     inhalation in models of lung injury, we performed a randomized clinical trial comparing PFC~     vapor inhalation with conventional mechanical ventilation（CMV）in patients with Acute Lung~     Injury/Acute Respiratory Distress Syndrome（ALI/ARDS）. The investigators will apply the~     Invasive Mechanical Ventilation (IMV) to the vaporized perfluorocarbon inhalation,~     objectively evaluate its curative effect on the acute respiratory distress syndrome, and~     meanwhile assess the safety of PFC.~   "
166111|NCT01391468|"~     This is a randomized double blinded placebo control studies are performed in Chronic Kidney~     Disease (CKD) patients. After informed consent, intervention group receives probiotics~     containing 109 CFU B. bifidum, B.catenulatum, B. longum, and L.plantarm), while placebo group~     receives corn starch. In the first year the investigators examine the 60 peritoneal dialysis~     (PD) patients, in the second year the investigators do the 60 hemodialysis (HD) patients, and~     in the third year the investigators do the 60 stage 3 and 4 CKD patients. Primary endpoint is~     cardiovascular event, gastrointestinal symptoms, peritonitis in PD patients, and progression~     of stage 3 and 4 CKD. Values are compared between the groups by unpaired t test. X2 testis~     used to compare proportions between the groups. Relative risk and the number needed to treat,~     both with 95% CI, are used to describe the treatment effect of probiotics. A p value less~     than 0•05 is regarded as statistically significant.~   "
166112|NCT01391455|"~     There are in excess of 1 million operations performed annually to repair inguinal hernias,~     mostly in the male population. Unfortunately, some patients continue to suffer both groin or~     testicular pain for varying lengths of time postoperatively. This can lead to a severe~     degradation of the patient's lifestyle, work habits and sexual function. The origin of the~     pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also~     involves the spermatic cord and its structures, leading to orchidinia and possibly~     azospermia.~   "
166113|NCT01391442|"~     The Stanislas Cohort is a monocentric familial longitudinal cohort comprised of 1006 families~     (4295 subjects) from the Nancy region recruited in 1993-1995 at the Centre for Preventive~     Medicine (Centre de Médecine Préventive, CMP), Vandoeuvre lès Nancy for a 5-year periodic~     health examination, under the auspices of the Caisse Nationale d'Assurance Maladie (CNAM).~      This cohort was established with the primary objective of investigating gene-gene and~     gene-environment interactions in the field of cardiovascular diseases, based on the study of~     inter-individual variability and familial segregation analysis of biological and~     morphological intermediate phenotypes of cardiovascular risk. The longitudinal nature of this~     study should enable to take into account the evolution of intermediate phenotypes related to~     genetic factors throughout the follow-up period. The families, consisting of two parents and~     at least two biological children, were deemed healthy, free of declared acute and/or chronic~     illness, in order to assess the effect of genetics on the variability of intermediate~     phenotypes studied under physiological conditions (without the influence, in the absence) of~     pathology.~      The Stanislas Cohort is, both nationally and internationally, the only longitudinal familial~     cohort of supposedly healthy subjects on such a large scale.~      Brief summary of ancillary study Cardiac Functional Indices Comparison Between MRI and~     Echocardiography : the ESCIF study is an ancillary study of the Stanislas cohort aiming at~     comparing in a cohort of supposedly healthy subjects different cardiac functional indices~     between two different modalities : Echocardiography and MRI. Indeed, new cardiac functional~     indices have been recently developed in the scope of echocardiography and would be very~     useful in MRI. In echography they are computed either from tissue Doppler imaging or from a~     specific image analysis called speckle tracking. These two techniques are accessible in MRI~     with the Generalized Reconstruction by Inversion of Coupled Systems (GRICS) technology which~     provides a motion model from which strains and strain rates may be derived and which allow~     longer acquisition without the constraint of breath holding (mandatory to reach high temporal~     resolution).~   "
166114|NCT01391429|"~     Subject preferences for care at the end-of-life show wide variability. In the setting of~     advanced disease, some subjects prefer all life-sustaining care while others forgo such~     procedures. The wide variability in preferences may be due to subjects' misconception of the~     disease condition when using solely verbal descriptions. The failure to participate in~     effective goals-of-care discussions may lead to overuse of medical interventions and~     life-sustaining measures that are inconsistent with patients' and families' wishes. Using~     video images -- in addition to words -- to convey goals-of-care options at end-of-life, adds~     a sense of verisimilitude to the condition described and may better inform subjects when~     making their preferences.~      Specific Aim: To assess the effect of a video decision support tool on preferences for~     end-of-life care in patients and surrogate decision makers consulted on by an inpatient~     palliative care service. The investigators hypothesize that those subjects who view video~     images as a supplement to a standard palliative care consult will be more likely to opt for~     comfort oriented care.~      In this study, patient subjects and/or their healthcare proxies who are consulted on by an~     inpatient palliative care team will be surveyed regarding their preferences for end-of-life~     care following either a standard palliative care consult or one which utilizes a short video~     to complement verbal descriptions. The primary analysis will involve the proportion of~     patient subjects/proxies in each group that prefer comfort oriented care and that die in~     accordance with their stated preferences. The investigators will also study the effect of the~     video on patient subjects' and/or proxies' uncertainty with regard to treatment preferences~     and overall satisfaction with the palliative care consult.~   "
166117|NCT01391390|"~     This is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on~     therapy to antipsychotics will be performed to examine the effects of melatonin on tardive~     dyskinesia symptoms and cognitive deficits in 120 patients with established tardive~     dyskinesia (TD). This study addresses a free radical hypothesis of TD.~   "
166118|NCT01391377|"~     Atherosclerosis is a disorder in the body that is characterized by cholesterol plaque~     formation in various arteries, causing narrowing of the artery and a limitation in blood~     flow. Depending on which artery the plaque is in, different clinical conditions occur. In~     adults common areas include in the heart arteries, in the neck arteries and in the aorta and~     lower leg arteries. When it affects the lower limbs it is known as peripheral arterial~     disease - PAD.~      The main symptom of PAD is called claudication and is described as pain or discomfort in~     the legs when walking. The aim of PAD treatment is to improve walking distance and quality of~     life in those with intermittent claudication, and to decrease long term complications~     including illness and death.~      An important controlling factor of these cholesterol plaques is a type of cholesterol called~     HDL (High density lipoprotein).~      This study aims to look at the effect that raising HDL for a prolonged period has on blood~     markers of inflammation and on the cholesterol plaque composition in patients with PAD. This~     investigation will also have relevance to the effects of HDL elevation on plaque composition~     and inflammation in other areas of the body including the heart, neck and brain arteries.~      Twenty (20) PAD patients with will be recruited into the study. The investigators anticipate~     recruitment of all 20 patients within 12 months. The 20 PAD patients all must have~     significant leg pains when walking, and after review by a doctor, be determined to have~     narrowings in the leg artery that they will plan to operate on. Patients will be randomized~     to either niacin (Tredaptive, 1g/day) or matching placebo for 8 weeks (prior to operation)~     After the 8 week period they will then go on to receive the normal interventional treatment~     as planned. Blood samples will be taken at enrollment and at the 8 week mark prior to~     surgery. The plaque that is removed at the time of operation will also be sent to the lab for~     analysis.~      The investigators hope to show with this study that by raising the levels of HDL with~     extended release niacin, there are positive effects on the amount of cholesterol in the~     plaque, and on the markers in the blood of inflammation and thrombosis.~      The hypothesis is that elevation of HDL with Niacin will have anti-atherosclerotic actions~     including: Lower plaque lipid content, Reduced plaque macrophage infiltration, Reduced~     monocyte activation, Reduced neutrophil adhesion, Inhibition of inflammation and Inhibition~     of thrombotic markers.~   "
166119|NCT01391351|"~     In order to search for predictors of response to chemotherapy in patients with ovarian~     carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will~     define the comparative profiles of miRNA expression of serum polymorphisms and determine~     differential in 2 patient populations (with or without recurrence 6 months after completion~     of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification~     of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the~     metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be~     studied during the first course in response to chemotherapy. Indeed, the miRNA profile of~     serum may be different at baseline among the 2 types of populations (or non-recurrence at 6~     months).~   "
166120|NCT01391338|"~     In this study several doses of ASP3652, given orally for 12 weeks, will be compared with~     placebo in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic~     Pain Syndrome.~   "
166121|NCT01391325|"~     This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the~     safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy~     (ULT) for up to six months. Allopurinol will be dosed according to the local product label,~     at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for~     each patient.~   "
166122|NCT01391312|"~     This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in~     glabellar rhytides (frown lines) using a new treatment satisfaction measure.~   "
166123|NCT01391299|"~     This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo~     for the treatment of forehead lines (facial rhytides) when also administered to frown lines~     (glabellar rhytides).~   "
166124|NCT01391286|"~     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with~     vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy~     treatment.~   "
166125|NCT01391273|"~     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with~     vehicle in Japanese adults with hypotrichosis of the eyelashes.~   "
166126|NCT01391260|"~     The purpose of this study is to access the effect and safety of radiotherapy combined whth~     Iressa for patients with locally advanced non-small cell lung cancer with harboring active~     EGFR mutations.~   "
166127|NCT01391247|"~     Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Up~     until today, very little is known about the metabolic alterations in the retina of glaucoma~     patients, since only techniques for surrogate measurements of metabolism (like blood flow~     velocities and vessel diameter) were available. Oximetry has provided us with an important~     tool to study metabolism in glaucoma, and to correlate these findings with the available~     blood flow evaluation techniques. Preliminary results by the group of Prof Stefánsson (2011)~     with the dual wavelength oximeter pointed out that deeper glaucomatous visual field defects~     are associated with decreased arteriovenous differences in retinal oxygen saturation. These~     data suggest that a change in oxygen metabolism occurs in glaucomatous retina. This reduced~     oxygen metabolism may be related to tissue atrophy. However, this explanation is still~     hypothetical, since the relation between these oximetry results and structural changes in the~     optic nerve have not been studied yet.~        1. What are the oximetry values in a normal population of within the same age group as the~          glaucoma population? To answer this question, a normative database of the investigators~          retinal oximetry device needs to be constructed for healthy controls.~        2. Do glaucoma patients have different retinal oximetry values than these normal patients?~          Are there any differences in retinal oxygenation between these glaucoma groups? To~          answer these questions, oximetry measurements will be performed in patients with normal~          tension glaucoma (NTG) and primary open angle glaucoma (POAG).~        3. Is there an association between structural optic disc and retinal nerve fibre layer~          changes, using Heidelberg Retinal Tomography (HRT), with alterations in retinal vascular~          oxygen saturation in NTG and POAG patients?~        4. Are blood flow measurements, using colour Doppler imaging (CDI), correlated with~          alteration in retinal vascular oxygen in NTG and POAG patients?~   "
166128|NCT01391234|"~     The purpose of this research study is to evaluate the safety and effectiveness of an~     experimental workflow that may result in a faster way to plan and deliver radiation for the~     treatment of pain caused by metastatic bone tumors (tumors that originally came from another~     organ and have spread to bones causing pain) or multiple myeloma (a type of cancer that~     begins in white blood cells that produce antibodies).~      The current standard of care radiation treatment planning and delivery takes 2 to 3 weeks~     from start to finish. The investigators have developed an experimental workflow: a radiation~     treatment planning and delivery workflow called STAT RT (STAT means right away, and RT~     means radiation therapy). This experimental workflow may shorten the time it takes to plan~     and treat painful bone metastases to 1 week or less. All steps in this process will be~     performed within the current standard of care but in a shorter time frame to allow treatment~     to start sooner.~      The investigators will evaluate effectiveness by requesting patients to complete pain and~     quality of life questionnaires before and after treatment. The investigators will also be~     collecting additional information from their treatments that will help us make future~     workflows even more efficient.~   "
196063|NCT00997035|"~     The purpose of this study is to determine if the addition of oral voriconazole to topical~     treatment regimens results in lower rates of perforation in severe fungal corneal ulcers.~   "
166129|NCT01391221|"~     Major depression is accompanied by cognitive changes as well as alterations in multiple~     physical functions. The inflammatory system is altered generally toward a pro-inflammatory~     state. Antidepressants are associated with a decrease in this proinflammatory state. This~     study aims to generate pilot data concerning a possible link between cognition, inflammation~     and response to treatment. The cognitive function of subjects with major depression will be~     tested before and after treatment with duloxetine. Inflammatory markers will be measured at~     both time points.~   "
166130|NCT01391208|"~     You are invited to participate in a research study to develop new ways to look for abnormal~     areas/tissues of the esophagus. The current endoscopes used to look at the esophagus are very~     good, but if the area doesn't look different to the naked eye, then the endoscope can't~     improve on that. The investigators are looking at using special fluorescent stains in~     addition to special endoscopes designed to see abnormal areas that are not obvious to the~     naked eye. Currently specialized microscopes and fluorescent stains are used in clinical~     laboratories but it takes several days of processing to get results. It may be very helpful~     to look for areas to sample for abnormal tissue during the endoscopy procedure.~      You are being asked to let us use fluorescent peptides with a special endoscope that allow~     us to see of your esophagus with both fluorescent and white light during your upper GI~     endoscopy procedure to help target your biopsies. Peptides are small chains of amino acids~     (the building blocks that make up proteins) linked together. Our peptide is a chain of 7~     amino acids attached to a fluorescent dye called FITC (like the one used by your eye doctor).~      The investigators have prepared special fluorescent peptides, that will glow when a~     special light is used that should help us separate normal tissue from abnormal tissue. In~     this study, the investigators will apply the special fluorescent peptides by a spray catheter~     to your esophagus to help us target you biopsies. Both routine and targeted biopsies will be~     taken as your endoscopist feels is indicated.~      This is a phase 1 study. This means that this is the first time the investigators have used~     this kind of fluorescent peptide in people. The Food and Drug Administration (FDA) has not~     approved this agent, but is allowing us to test it in this study. The main goal of this study~     is to see if there are any side effects from using the peptide. Our second goal is to see if~     the peptide glows well and if the investigators can take pictures of the areas that do~     glow.~      This is the first test of this agent, so it won't be used to change how your biopsies are~     taken nor how your endoscopy is done.~   "
166131|NCT01391195|"~     The study hypothesis is an increase in muscle performance and a higher aerobic adaptation of~     young women submitted to chronic endurance training program associated to low level laser~     therapy when compared to chronic aerobic training alone.~   "
166132|NCT01391182|"~     You are being asked to take part in this research study because you are scheduled to have~     total hip replacement (arthroplasty) surgery. The goal of this study is to evaluate the~     effectiveness of the drug, epsilon Aminocaproic Acid (EACA), in decreasing the need for~     patients to receive blood after surgery. Currently, EACA is approved by the Federal Drug~     Administration (FDA) to treat a patient who is bleeding. The investigators plan to use EACA~     to prevent bleeding during and after surgery; use of this drug as a means of preventing~     bleeding is not currently approved by the FDA.~   "
166133|NCT01391169|"~     This is a control matched prospective study evaluating the use of seromuscular flap for high~     risk anastomoses.~   "
166134|NCT01391156|"~     The purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil~     with 0.1% Finasteride lotion for 6 months in male pattern hair loss.~   "
166135|NCT01391143|"~     The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV)~     infusion to patients with refractory cancer. The study will also evaluate how long MGA271~     stays in the blood and how long it takes for it to leave the body, what is the highest dose~     that can safely be given, and whether it may have an effect on tumors.~   "
166136|NCT01391130|"~     To compare the progression free survival of LY2510924 plus sunitinib therapy versus sunitinib~     in the first-line setting for patients with metastatic clear-cell renal cell carcinoma.~   "
166137|NCT01391117|"~     The purpose of this study is to determine in genotype 1 Hepatitis C Virus (HCV)-infected~     participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the~     body, how it is distributed within the body and removed from the body over time) and~     antiviral activity of repeated doses of TMC649128 given as monotherapy and given in~     combination with pegylated interferon + ribavirin. We assess the~     pharmacokinetic/pharmacodynamic (how the study medication affects the body) (PK/PD)~     relationship for antiviral activity, active metabolite and safety of TMC649128 and its~     metabolites. We determine the short term safety and tolerability of the co-administration of~     TMC649128 and pegylated interferon + ribavirin during multiple dosing for 14 days in~     treatment-naive genotype 1 HCV-infected participants. We explore the effect of pegylated~     interferon + ribavirin on the pharmacokinetics of TMC649128 during the multiple dosing for 14~     days in treatment-naive genotype 1 HCV-infected participants. We also assess in a preliminary~     way the short term antiviral effect of the combination of TMC649128 with pegylated interferon~     + ribavirin during a 14-day dosing period in treatment-naive genotype 1 HCV-infected~     participants.~   "
166138|NCT01391104|"~     Pulmonary arterial hypertension (PAH) is characterized by the progressive increase in~     pulmonary vascular resistance leading to shortness of breath and exercise intolerance.~     Exercise capacity has been used as the primary endpoint in most recent randomized controlled~     trials evaluating PAH-specific therapies as it correlates with functional class and survival~     in PAH. Exercise test is commonly assessed by the six-minute walk test (6MWT). However, there~     is commonly some discrepancy between significant clinical improvement and minor changes~     (generally <10% from baseline) in 6WMT following therapy. Because important clinical~     decisions are based on patients' functional capacity, a reproducible and sensitive exercise~     test is needed in PAH. The aim of this study was to compare the reproducibility and the~     responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance~     test (CET) following pharmacological therapy in this disease.~   "
166139|NCT01391091|"~     The purpose of this prospective study is to evaluate the effect of catheter ablation on~     incidence, prevalence and disease-severity of migraine in AF patients undergoing ablation,~     with or without a history of migraine.~   "
166140|NCT01391078|"~     This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF)~     continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma~     patients. There are two control measurements: The GAT/Perkins profile in the same eye in the~     second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each~     eye serves as test eye and also as control for the second test eye.~   "
166224|NCT01389986|"~     Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer,~     paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function~     through the cephalic-vagal reflex and increased intestinal enzymes secretion.~      The objectives of this study are to evaluate effects of adding gum chewing to the~     conventional postoperative feeding protocol on the return of bowel function, its related~     complications, and patients' satisfaction.~   "
166141|NCT01391065|"~     The proposed two stage study will evaluate patterns of local recurrence after EBRT and~     brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in~     patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The~     first stage of the study will focus on developing MR guided interstitial brachytherapy and~     validating the concept of high risk gross tumor volume (on the basis of functional imaging~     features).~      The second stage thereafter will focus on developing biologically modulated interstitial~     brachytherapy.~      In the proposed two staged study the investigators intend to prospectively evaluate and~     validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy.~     The demonstration of technical feasibility and clinical safety of biologically modulated~     image guided radiotherapy in this pilot study for may pave the way for improving local~     control in patients with postoperative recurrences.~   "
166142|NCT01391052|"~     Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side~     effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy~     menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of~     post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively~     slough the endometrium prior to insertion of the LNG IUS.~   "
166143|NCT01391039|"~     This is a pilot study designed to investigate new techniques to guide the appropriate~     diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and~     stiffness of the lesion may be prognostic factors that can guide the need for more or less~     extensive therapy or perhaps only imaging follow-up may be needed.~   "
166144|NCT01391026|"~     Patients who have advanced or multiple chronic illnesses present management difficulties for~     primary care providers. Acute medical issues and limited time for patient evaluation can~     complicate complete assessment of physical symptoms that directly impact a patient's quality~     of life. The Cook County Health and Hospitals System (CCHHS) established an Advanced Illness~     Management Clinic to provide care for complex patients. Patient entry into the Advanced~     Illness Management Clinic is by referral only, a passive process. After discharge, general~     medicine clinic patients who do not have a medical provider are given an appointment in the~     clinic. Since the hospital is the source of many patients, this guarantees that these~     patients will have at least one illness advanced enough to require hospitalization, and most~     will have additional chronic illnesses. An outpatient palliative care clinic located in a~     specialty clinic setting was initiated in 2004. The goal of the clinic was to extend the~     benefits realized by hospital patients, for whom palliative care consultation has been~     available for many years, to patients cared for in the outpatient setting. The benefits~     provided include physical symptom management, spiritual counseling, and support for social~     issues. Until recently, this outpatient palliative care model has mainly served patients with~     malignancy. With the addition of the Advanced Illness Management Clinic, palliative care~     clinicians now can provide care to patients with other chronic and serious illness in the~     primary care setting.~      Hypothesis: Complex patients will have improved quality of life and a reduced symptom burden~     if seen by a multidisciplinary clinic post-hospitalization, compared to usual care in a~     general medicine clinic.~   "
166145|NCT01391013|"~     The purpose of this study is to compare change of brachial artery flow mediated~     vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use~     of a single medication) versus a triple combination therapy containing 2 nucleoside reverse~     transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected~     participants.~   "
166146|NCT01391000|"~     The purpose of this study is to evaluate the most effective method between Transcutaneous~     Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy~     carbon dioxide therapy for pain control in the post-surgical rehabilitation of patients~     treated with reconstruction of the rotator cuff.~   "
166147|NCT01390987|"~     Prompt access to care and treatment adherence are the hearth of tuberculosis control.~      This is a multicentre observational prospective study aimed at studying the factors~     associated with delayed access to care and low adherence to anti-tuberculosis treatment.~     Hetero- and self-administered questionnaires will be used at enrollment to assess clinical~     presentation and time and modalities of the diagnosis. Treatment adherence will be assessed~     during the follow-up with self administered questionnaires.~   "
166148|NCT01390974|"~     To demonstrate that a strategy of fast genetic testing performed in outpatient clinic allows~     to select adequately one of the 2 antiplatelet treatments approved in the same indication~     (ACS with PCI - prasugrel 10mg MD or clopidogrel 75mg MD). Patients will reach similar levels~     of platelet inhibition with the 2 different thienopyridines suggesting optimal risk/benefit~     ratio in most patients with individualized therapy.~   "
166149|NCT01390961|"~     Comfort is compared between two allergy drops~   "
166150|NCT01390948|"~     This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety,~     tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy~     with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant~     and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically~     confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or~     infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be~     randomly assigned to one of two treatment arms.~      Upon approval by the Health Authorities/Ethics Committees in the participating countries, an~     additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with~     progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO~     Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab~     and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year.~   "
166151|NCT01390935|"~     The purpose of this study is to survey the guideline compliance of the cardiologists in the~     treatment of systolic heart failure in Korea~   "
166152|NCT01390922|"~     The objective of this post-marketing surveillance study is to collect safety, efficacy and~     usage data on botulinum injection in subjects with upper or lower limb spasticity on the~     long-term use in clinical practice and to identify the factors affecting the safety or~     efficacy.~   "
166225|NCT01389973|"~     The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients~     with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.~   "
166153|NCT01390909|"~     Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy;~     however, complete seizure control remains elusive for many patients. Uncontrolled or~     refractory epilepsy is associated with a higher risk of mortality, physical injuries, and~     depression or anxiety compared with patients with controlled epilepsy. Higher resource~     utilization for patients with poor control is likely to be associated with higher economic~     costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists,~     recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one~     seizure per month and 2.) a history of drug failures.~      The objective of this study is to identify patients with uncontrolled epilepsy in both a~     Medicaid database and a private health plan database, to describe patient characteristics and~     AED treatment patterns between cohorts of patients with uncontrolled versus well-controlled~     epilepsy, and to evaluate the economic burden of uncontrolled versus well-controlled~     epilepsy.~      For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases~     from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second~     quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter~     1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and~     medical and pharmacy claims in an private health plan database.~      The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient~     records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy~     (at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1~     epilepsy-related inpatient or emergency department (ED) visit within 365 days),~     well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits), and~     intermediate epilepsy (not classified as uncontrolled or well-controlled).~   "
166154|NCT01390896|"~     The purpose of this study is to collect and assess information on safety and efficacy of~     fondaparinux in patients undergoing general surgery of the lower limb at high risk of~     developing venous thromboembolism.~   "
166155|NCT01390883|"~     The purpose of this study is to collect and assess information on safety and efficacy of~     fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology~     departments who are at high risk of venous thromboembolism.~   "
166156|NCT01390870|"~     Patient-based surveys will be conducted to evaluate the drivers of medication adherence in~     patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB)~     therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be~     evaluated. The researchers believe that the majority of participants will report that they~     are compliant with therapy. The data source is a cross-sectional patient survey administered~     at one time point.~   "
166157|NCT01390857|"~     The purpose of this post-marketing surveillance study is to collect and assess information on~     safety and efficacy of valaciclovir in pediatric patients with chickenpox~   "
166158|NCT01390844|"~     This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron~     (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared~     to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C~     (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia~     Pacific population. The primary hypothesis is that the proportion of participants achieving~     sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to~     that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.~   "
166159|NCT01390831|"~     The purpose of this study is to determine whether renal denervation is safe and effective in~     the treatment of Chinese patients with uncontrolled hypertension.~   "
166160|NCT01390818|"~     This research trial is testing a combination of two experimental drugs, MSC1936369B~     (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and~     SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR)~     inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary~     purpose of the study is to determine the maximum tolerated dose of the drug combination.~   "
166161|NCT01390805|"~     The purpose of this study is to collect and assess information on proper use of valaciclovir~     regarding safety and efficacy of long-term use in suppressive therapy for subjects with~     recurrent genital herpes.~   "
166162|NCT01390792|"~     The purpose of this post-marketing surveillance study is to collect information on efficacy~     and safety for prophylactic administration of zanamivir in clinical practice in family or~     persons living with patients with influenza virus infection.~   "
166163|NCT01390779|"~     The objectives of this study are to assess the safety and effectiveness of the SENSIMED~     Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular~     pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of continuous~     TF recording.~      TF efficacy will be evaluated by demonstrating TF ability to detect:~        1. The known phenomenon of increase in IOP when moving from waking state to going to bed,~          as reflected in pneumotonometer measurements~        2. Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).~      A screening visit and one 24-hour IOP fluctuation recording session are planned for each~     patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An~     ophthalmological examination of the eyes will be done at screening and prior to and following~     the device recording.~   "
166164|NCT01390766|"~     This post-marketing surveillance (PMS) study is designed to investigate the efficacy and~     safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.~   "
166165|NCT01390753|"~     Acute respiratory infections are the leading cause of hospitalization in premature infants~     worldwide. Severity rates are particularly high in developing countries. Numerous viruses can~     cause severe disease, but the most frequent agent of hospitalization is respiratory syncytial~     virus (RSV). In a recent study in Argentina, 58% of RSV infected VLBW infants required~     hospitalization and 19% required mechanical ventilation. One every twenty infected infants~     died. Unlike industrialized nations, VLBW infants in developing countries often lack access~     to prophylaxis against RSV with a commercially available monoclonal antibody (palivizumab).~     No vaccine or preventive intervention is available against any respiratory virus for infants~     younger than 6 months of age in developing countries and the public sector of most~     middle-income countries.~      The protective role of breastfeeding against respiratory infections in developing countries~     is well established. But while similar beneficial effects have been described for premature~     infants, the dropout rate for breastfeeding in families exposed to the uncertainties and~     stress of the early months of life in the neonatal intensive care unit is very high. The~     World Health Organization recommends the use of Human Milk Donor Banks to feed infants that~     cannot be breastfed by their own mothers. These banks are established with the purpose of~     collecting, screening, processing (including pasteurizing), testing and distributing donated~     human milk. The potential benefit of donated milk against acute disease elicited by RSV is~     unknown. The investigators propose to study the role of supplemental donated human milk in~     the prevention of hospitalizations caused by RSV in non-breastfeeding premature infants.~     Since the investigators expect the benefits of breast milk to extend beyond protection~     against RSV, the effect of human milk against respiratory infections elicited by other~     viruses will also be evaluated.~   "
166237|NCT01389804|"~     The overall long term objective of this research is to improve health care utilization and~     quality of life of pediatric solid organ transplant recipients and family. Understanding the~     process of transition to a chronic medical condition during the acute (3 weeks after~     transplant) and long term (3 and 6 months) will significantly guide the development of~     clinical interventions aimed at maximizing adherence and family psychosocial adjustment.~   "
166166|NCT01390740|"~     Study of the prevalence of Abdominal Aortic Aneurysms (AAA) (> 3 cm) in patients with~     echocardiography (transthoracic or) during a specific day, with cardiologists in France.~      This is a cross-sectional epidemiological investigation, assembling evidence from a routine~     ultrasound screening for AAA at the waning of echocardiograms performed during a specific~     day.~      The study will be offered a list of centers selected by the Scientific Committee in the~     complete list of locations being in France, the subsidiary of echocardiography~     Echocardiography of French Society of Cardiology. These centers will be 500 in number~     representative of the French centers, geographically and by type of centers.~   "
166167|NCT01390727|"~     Hypertension is a chronic disease that affects about 23% of the brazilian population. The~     treatment of hypertension by pharmacological intervention is efficacious, but has side~     effects and significant costs. Techniques that reduce the respiratory rate are shown as a~     effective non-pharmacological treatment in controlling blood pressure. Evidence has shown~     that a slow and deep breathing rate, around 10 breaths per minute or less, significantly~     reduces blood pressure. However, the physiological mechanisms involved in blood pressure~     decrease due to decreased respiratory rate are not yet known. Therefore the goals of this~     study will evaluate the chronic effect of breathing exercise guided on office and 24 hours~     blood pressure and analyse the chronic effect of breathing exercise guided over the autonomic~     function in hypertensive patients in stages 1 and 2.~   "
166168|NCT01390714|"~     The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of~     E3710 following oral administration to Healthy Male Japanese Subjects~   "
166169|NCT01390701|"~     The purpose of this study is to compare the blood pressure reducing property of~     transcutaneous electrical nerve stimulation with the blood pressure reducing drug felodipin.~   "
166170|NCT01390688|"~     Individuals with type 2 diabetes have an increased risk of developing cognitive dysfunction~     followed by dementia in late life. Obesity, physical inactivity and systemic low-grade~     inflammation are strong risk factors and play a crucial role in this network of diseases.~      Brain-derived Neurotrophic factor (BDNF) is produced in brain as well as several tissues~     outside brain eg muscle cells. Low BDNF are associated with cognitive dysfuction, obesity and~     type 2 diabetes.~      The investigators include 200 individuals divided into three groups: 80 individuals with type~     2 diabetes, 80 age and BMI-matched controls and 40 individuals with impaired glucose~     tolerance.~      The project will test the hypothesis, that low systemic BDNF are associated with accumulation~     of abdominal fat, cognitive dysfunction and insulin resistence with different effect in men~     and women.~   "
166171|NCT01390675|"~     In modern cardiac surgery and cardiology Transcatheter Aortic Valve Implantation (TAVI) is an~     emerging procedure for high-risk patients that are assumed to be otherwise inoperable. The~     investigators want to evaluate the specific intraoperative anesthesiologic characteristics~     cardiac anesthesiologists have to face during these procedures.~   "
166172|NCT01390662|"~     The purpose of this study is to investigate whether patients with depression should be~     offered vitamin D supplements, or it has no significance in relation to treatment outcomes.~   "
166173|NCT01390649|"~     It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not~     known in detail. The primary objective of this study was to investigate the specificity of~     antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (ITP)~     who have shown signs of clinically relevant hemolysis following treatment with the~     intravenous immunoglobin Privigen®. The study was to explore potential mechanisms of~     hemolysis by analysis of the specificity of the antibodies possibly involved. To distinguish~     between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an~     independent adjudication by a committee was performed for each patient with signs of~     hemolysis determined in the laboratory or in the clinic.~      This study was requested as a post-marketing commitment study by the United States Food and~     Drug Administration (FDA). By September 2014, no case of clinically significant intravascular~     hemolysis was found, and the FDA agreed to halt the study and analyze all hemolysis-relevant~     endpoints using FDA criteria for hemolysis in addition to analyses planned in the protocol.~     The study was not restarted.~   "
166174|NCT01390636|"~     The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to~     determine the degree of variation in glucose levels of individuals with an eating disorder~     and type 1 diabetes and only an eating disorder.~   "
166175|NCT01390623|"~     Urinary tract community infections are one of very frequent reason consultation and~     prescription. Urinary tract represents the second site of bacterial community infection after~     the respiratory system. The management of the acute uncomplicated pyelonephritis was simply~     codified in the past recommendations of the French Agency for Safety Health Products~     (AFSSAPS) in 2008. Treatment is based on two main families of antibiotics, fluoroquinolones~     with 7 days treatment and 3rd generation cephalosporins with 10 to 14 days treatment.~      The practice of a short treatment with ceftriaxone intra venous relayed by cefixime orally~     provides a simplified treatment for patients, a reduced use of fluoroquinolones and a~     probable decrease in correlation with the emergence of fluoroquinolones resistance, and~     finally, a decrease in the cost of treatment of acute uncomplicated pyelonephritis.~   "
166176|NCT01390610|"~     The purpose of this study is to use data from the Continuous Glucose Monitoring (CGM) device~     and your Self-Monitored Blood Glucose (SMBG) levels to determine the best times to test blood~     glucose levels using SMBG.~   "
166177|NCT01390597|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors find better ways to treat the cancer.~      PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with~     peripheral T-cell lymphoma or natural killer cell neoplasms.~   "
166194|NCT01390376|"~     Pharmacotherapy for schizophrenia has limitations such as residual positive and negative~     symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia~     (particularly clozapine-resistant) is still a difficult clinical issue at present. According~     to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have~     therapeutic benefit. DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing~     agents.~      The aim of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant~     treatment for clozapine-resistant refractory schizophrenia patients in a randomized,~     double-blind, placebo - controlled trial.~   "
166178|NCT01390584|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate,~     vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride,~     vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x rays to kill cancer cells. Giving combination chemotherapy together with~     radiation therapy may kill more cancer cells. Comparing results of imaging procedures, such~     as PET scans and CT scans, done before, during, and after chemotherapy may help doctors~     predict a patient's response to treatment and help plan the best treatment.~      PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan~     works in treating patients with stage I or stage II Hodgkin lymphoma.~   "
166179|NCT01390571|"~     RATIONALE: Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Olaparib may help temozolomide kill more tumor cells by making tumor cells more~     sensitive to the drug.~      PURPOSE: This phase I trial is studying the side effects and best dose of olaparib and~     temozolomide in treating patients with relapsed glioblastoma.~   "
166180|NCT01390558|"~     This is a research study of persons with Down Syndrome between 2 and 80 years old who are~     independently walking. The purpose of this study is to see what effect orthotics have on how~     people with Down Syndrome walk.~   "
166181|NCT01390545|"~     This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm~     parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of~     veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc)~     injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative~     veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on~     continued stable co-medication with methotrexate (MTX).~   "
166182|NCT01390532|"~     Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with~     advanced heart failure and left ventricular dyssynchrony (LVD). Too many patients do not~     clinically improve with CRT. New LVD markers other than QRS duration are needed.~      Study objective : feasibility assessment of rest and real-time stress 3D Blood-Pool Gated~     SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®,~     Ceasaria, Israel) to quantify LVD.~   "
166183|NCT01390519|"~     This is a Norwegian prospective registration, observational study of patients with advanced~     renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI)~     ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these~     patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.~   "
166184|NCT01390506|"~     After cardiac arrest and successful resuscitation it can happen that the brain function of a~     patient is impaired because the brain was without oxygen for a prolonged period of time.~     Several strategies have been studied to improve brain function after cardiac arrest. Cooling~     of the patients is routinely used today. The trace element selenium has several biological~     functions and is important for defense mechanisms against oxidative stress, which occurs~     after cardiac arrest and successful resuscitation. critically ill patients have low selenium~     blood levels. Therefore the investigators hypothesize that giving selenium after cardiac~     arrest and successful resuscitation might improve brain function.~   "
166185|NCT01390493|"~     The purpose of this study is to determine whether neurofeedback training can significantly~     reduce the symptoms of anorexia nervosa (AN) with focus on changes in personality and~     psychological well-being. The primary aims of this study include:~        1. To examine whether AN patients are able to control their alpha-activity through~          neurofeedback.~        2. To examine the effects of neurofeedback on symptomatology and personality variables in~          AN patients.~        3. To examine the long-term effects of neurofeedback in the treatment of AN.~   "
166186|NCT01390480|"~     In this placebo controlled study the investigators aim to investigate the effects of vitamin~     D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine~     and metabolic parameters.~   "
166187|NCT01390467|"~     Randomized study, double-blind, crossover, controlled versus placebo.~   "
166188|NCT01390454|"~     Our primary objective is to study the relationship between ultra sound data and the pain~     associated with tennis elbow.~   "
166189|NCT01390441|"~     This is a study of the overall safety, tolerability, and pharmacokinetics (PK) of MK-8808~     versus rituximab (MabThera® and Rituxan®) in participants with moderate to severe RA with an~     inadequate response or intolerance to methotrexate.~   "
166190|NCT01390428|"~     This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered~     to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria~     of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy~     participants.~   "
166191|NCT01390415|"~     This study will evaluate whether losartan protects the kidney in hypertensive Type II~     diabetic participants with microalbuminuria.~   "
166192|NCT01390402|"~     The goal of this clinical research study is to learn if giving a kind of immune cell called~     natural killer (NK) cells after chemotherapy will improve the response to a stem cell~     transplant in patients with CML. The safety of this treatment will also be studied.~   "
166193|NCT01390389|"~     The investigators propose to study and compare measures of brain energy metabolism in~     geriatric bipolar individuals and healthy older adults. The investigators would also like to~     investigate changes in brain energy metabolites associated with CoQ10 administration in older~     bipolar individuals. Finally, resting state functional Magnetic Resonance Imaging (fMRI) will~     be conducted in order to explore frontal and limbic circuitry in geriatric bipolar disorder.~        -  Primary Hypothesis: Baseline beta NTP and NAA will be lower, and PCr and lactate higher~          in Geri BPD compared with older healthy controls~        -  Secondary Hypothesis: Changes in PCr and beta NTP will be demonstrated in Geri BD group~          challenged with CoQ 10.~   "
166195|NCT01390363|"~     The purpose of this study is to determine whether contacting the parents of adolescents~     overdue for routine vaccines or contacting both the parents AND adolescents overdue to~     routine vaccines improves immunization rates as compared to usual care.~   "
166196|NCT01390350|"~     This is a multi-center double-blind placebo-controlled study to assess the efficacy and~     safety of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that~     neutralizes IL-1β, in patients with Schnitzler syndrome. Efficacy is assessed by physician's~     global assessment (a combined clinical symptom score) and inflammation markers. Following a~     baseline period of 1-4 weeks, patients will be randomized to receive single s.c. injections~     of either 150 mg canakinumab or placebo (day 0). Treatment response will be assessed on day~     7. Patients will then be eligible to enter the 16-week open-label phase and receive~     canakinumab injections (150-300mg, dose depends on clinical response on day 7) upon relapse~     of symptoms. Visits for investigator's assessments will be scheduled at 4-weekly intervals~     following day 7. Overall a max. of 20 subjects with Schnitzler syndrome will be enrolled.~        1. Amendment: After successful completion of the 16-week open-label phase patients will be~          eligible to enter a one-year open-label extension of the study. During this part of the~          study patients will be scheduled at bi-monthly intervals. Canakinumab dosing will be~          performed upon relapse of symptoms comparable to the 16-week open-label phase.~        2. Amendment: After successful completion of the 1-year open-label study extension patients~          will be eligible to enter another 3-year open-label extension. Patients will be~          scheduled at 3-month-intervals and Canakinumab dosing will be performed on an individual~          basis with optimized dosing intervals to ensure a constant low disease activity.~   "
166197|NCT01390337|"~     The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when~     combined with induction and consolidation therapy and as maintenance therapy following~     induction and consolidation.~   "
166198|NCT01390324|"~     The purpose of this study is to determine whether a fixed-dose combination of naratriptan +~     naproxen is effective compared each monotherapy for the acute treatment of migraine.~   "
166199|NCT01390311|"~     This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the~     standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or~     myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC~     includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or~     DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the~     function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while~     maintaining the anticancer effects.~   "
166200|NCT01390298|"~     The purpose of this study is to provide preliminary data for a Program Project Grant to the~     National Institutes of Health to examine specific explanations regarding identifying patients~     at risk for chronic pain after surgery and identifying mechanisms which may be altered to~     decrease this risk.~      This study will help investigators better understand chronic pain that develops after~     surgery. We are proposing to study different factors related to the surgical experience and~     factors in the environment to determine if any play a role in the development of chronic pain~     after surgery.~   "
166201|NCT01390285|"~     Background~      Central sensitization has recently been documented in patients with knee osteoarthritis. So~     far, the presence of central sensitization has not been considered as a confounding factor in~     studies assessing the pain inhibitory effect of TENS on osteoarthritis of the knee.~      Purpose~      First, to explore the pain inhibitory effect of burst TENS in OAk patients. Second, to~     explore the prognostic value of central sensitization on the pain inhibitory effect of TENS~     in Oak patients.~      Methods~      Patients with knee pain due to OAk will be recruited through advertisements in local media.~     Temporal summation, before and after a heterotopic noxious conditioning stimulation, will be~     measured. In addition, pain on a numeric rating score and WOMAC subscores for pain and~     function will be assessed. Patients will be randomly allocated to one of two treatment groups~     (TENS, sham TENS). Follow-up measurements will be scheduled after a period of 6 and 12 weeks.~      Discussion/ conclusion~      TENS influences pain through the electrical stimulation of low-threshold A-beta cutaneous~     fibers. The responsiveness of central pain-signaling neurons of OAk patients who are~     centrally sensitized may be augmented to the input of these electrical stimuli. This would~     encompass an adverse therapy effect of TENS. Therefore it might be interesting to identify a~     subgroup of symptomatic OAk patients, ie. non-sensitized patients, who are likely to benefit~     from burst TENS.~   "
166202|NCT01390272|"~     This randomized clinical trial examines whether programs aimed at matching resources to~     patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic~     blood pressure (top number of blood pressure reading) than simply having maintenance phone~     calls in addition to usual care. Answering this question will provide important evidence~     concerning the overall goal of sustained long-term implementation of the disease management~     programs as part of patient aligned care teams in the Veterans Affairs and other healthcare~     systems.~   "
166203|NCT01390259|"~     In this protocol the investigators plan to demonstrate management of glucose using a modular~     insulin management system based on continuous glucose monitoring and targeted towards the~     avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The~     protocol is designed to challenge the insulin management system with meals and mild exercise,~     so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic~     state. This system is designed to both~        -  monitor the meal boluses of the patient and correct it in case of observed/predicted~          under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and~          subjective knowledge of the meal amount, a precise understanding of the subject's day to~          day insulin treatment, continuous glucose monitoring, and past insulin injections;~        -  predict and avoid hypoglycemic events, based on continuous glucose reading and past~          insulin injection.~      The investigators plan to enroll 12 adolescent T1DM patients (expected retention 10/12) and~     compare glucose control performances under two treatments: standard vs. the new insulin~     management system. The protocol will include a total of 5 admissions per subject (3~     out-patients and 2 in-patients): screening, CGM insertion 1, CGM insertion 2, inpatient 1 and~     inpatient 2. During the 24h inpatient admissions the patients will be challenged with 30~     minutes of mild exercise and 3 meals, insulin coverage of these events will vary depending on~     the chosen treatment, each subject will be exposed to both studied treatments (repeated~     measure design). The order of treatment during the inpatient admissions will be randomized.~   "
166204|NCT01390246|"~     This is a prospective, double-blind placebo-controlled randomized pilot trial of the~     preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for~     smoking cessation during pregnancy.~   "
166205|NCT01390233|"~     This study is designed to assess the effectiveness of a combination method of induction of~     labor using a urinary balloon catheter and prostaglandin gel.~      The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery~     rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed~     induction in the United States is rising. This has led to a renewed effort to examine the~     effectiveness of the varied methods of induction.~      The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel~     for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto~     Health Richland for a scheduled induction of labor will be offered enrollment in the trial.~     Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon~     catheter only, prostaglandin gel only and combination urinary balloon catheter and~     prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication~     storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The~     investigator will be given the next sequentially numbered study randomization envelope by the~     patient's nurse. The randomization assignment will be unblinded to the patient and her~     physicians. If the patient is not in active labor 6 hours after initiation of the~     intervention, a standardized protocol of oxytocin will commence. Labor management will be at~     the discretion of the physician.~   "
166206|NCT01390220|"~     The purpose of this study is to examine the safety and effectiveness of USL261 for the~     outpatient treatment of seizure clusters.~   "
166207|NCT01390207|"~     The effect of altering the timing of hCG administration on the ongoing pregnancy rate in~     patients stimulated with recombinant-FSH (rec-FSH)/gonadotrophin releasing hormone (GnRH)~     antagonists for in vitro fertilisation (IVF).~   "
166208|NCT01390194|"~     The purpose of this study to assess the image quality of the rapid MRI compared to the~     standard MRI.~   "
166209|NCT01390181|"~     The specific aims of this study are to:~        -  Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in~          individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements~          >40mm.~        -  Assess the effect on MMP levels during treatment with losartan, an angiotensin II~          receptor blocking agent.~        -  In the setting of losartan therapy for one year, evaluate the response of MMP levels in~          these patients, and clinical outcomes including effects on aortic growth rate~   "
166210|NCT01390168|"~     The purpose of this study is to determine whether tailored internet-administered cbt is a~     feasible treatment for anxiety disorders in clinical settings.~   "
166211|NCT01390155|"~     Esophageal electrocardiography (eECG) has important advantages compared to standard ECG~     recordings.~      Coronary artery disease leading to myocardial ischemia is very common and has potentially~     severe consequences for patients. To date, the investigators don't know the influence of~     ischemia on the eECG. The goal of the present study is to assess ischemic changes of the eECG~     induced by balloon occlusion of coronary arteries in patients undergoing coronary~     angiography.~   "
166212|NCT01390142|"~     RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis~     that remote ischemic preconditioning initiated at the time of the admission in the cathlab~     reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated~     with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a~     combined approach remote ischemic preconditioning and local ischemic postconditioning can~     further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance~     imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.~   "
166213|NCT01390129|"~     RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote~     ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in~     aortic valve surgery. Infarct size will be determined by 72 hours area under curve of~     troponin-I.~   "
166214|NCT01390116|"~     The purpose of this study is to determine whether consuming capsules of aged garlic extract~     is effective in enhancing function of NK and/or γδ T cell resulting in fewer cold and flu~     symptoms.~   "
166215|NCT01390103|"~     The purpose of this project is to determine the effect of hip injections on hip biomechanics~     in patients with hip pain.~   "
166216|NCT01390090|"~     Subjects will have failed conservative treatment, including, but not limited to oral~     medications, physical therapy, manual manipulation, and/or alternative medicine. They will be~     evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and~     will be scheduled for a piriformis muscle (PM) corticosteroid injection.~   "
166217|NCT01390077|"~     Nitisinone is a potent inhibitor of the enzyme that catalyzes the formation of homogentisic~     acid, and should be an even more logical treatment for alkaptonuria than for tyrosinemia, for~     which it has been approved by the FDA.The objective of this research is to explore reported~     age related differences in toxicity of nitisinone and its pharmacokinetic underpinnings and~     to develop an optimal therapeutic requirement for a targeted population of presymptomatic~     patients. The additional effect of mixtures of amino acids excluding tyrosine will be~     explored to take advantage of protein synthesis to avoid elevations of tyrosine that would~     otherwise limit the optimal dosage of nitisinone. The study is designed to treat patients and~     find the optimal dosage of nitisinone to obtain maximal reduction in levels of homogentisic~     acid and maintain safe levels of tyrosine.~      The long term objective in the target population of pre-symptomatic patients is the~     prevention of the characteristic effects on joint cartilage and tendons.~   "
166218|NCT01390064|"~     Objective - Determine the safety and tolerability of a peptide mimotope-based vaccine upon~     immunization of breast cancer subjects.~   "
166219|NCT01390051|"~     The purpose of the study is to investigate if treatment with an anticoagulant drug increases~     birth weight in pregnancies complicated by fetal growth restriction.~   "
166220|NCT01390038|"~     The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder~     System in total shoulder arthroplasty.~   "
166221|NCT01390025|"~     The purpose of this study is to compare the safety profile in healthy volunteers of a single~     intravenous administration of TCN-032 as compared with placebo.~   "
166222|NCT01390012|"~     The purpose of this study is to assess bioequivalence for dexamethasone administered orally~     versus intravenously in patients admitted to hospital for pneumonia.~   "
166226|NCT01389947|"~     Digestive tract is supposed to be the motor of multiple organ failure. In ICU patients,~     mesenteric ischemia appears even when macrocirculatory parameters are controlled especially~     in our experience in patients coming in ICU after a cardiac surgery. The investigators~     suppose that microcirculatory failure develops and results in suffering of non major organs~     like muscle, skin and digestive tracts. In this study the investigators monitor digestive~     tract with plasmatic IFABP dosage and microcirculatory circulation with NIRS during a VOT and~     plasma glycocalyx measurements. The population is composed by patients having coronary artery~     bypass during cardiopulmonary bypass.~      The first aim of this study is to show that digestive tract is suffering with the use of~     extracorporeal circulation and will be assessed with Plasmatic Intestinal Fatty Acid Binding~     Protein when IFABP will more than 300 pg/ml ; and with citrullinemia when citrullinemia will~     be less than 20 micromol/L.~      The second aim is to investigate link between endothelial dysfunction and digestive tract.~     Endothelial dysfunction is assessed with tissular oxygen saturation before, during and after~     a vascular occlusion test of 3 minutes (measurement of basal value, desaturation curve,~     resaturation curve and hyperemic response by measurement of area under curve). Endothelial~     glycocalyx and NO pathway will be investigate (see under)~      Our objective is to enroll 100 patients. The same study will be done in a group of patients~     who benefit from coronary artery bypass without extracorporeal circulation to see the effects~     of extracorporeal circulation support.~   "
166227|NCT01389934|"~     Background: The use of local anesthetics as a supplement to conventional techniques in breast~     surgery is widely reported in the literature. Currently there is controversy regarding the~     efficacy of surgery for breast infusion of local anesthetic after surgery. The aim of this~     study demonstrate the efficacy of administering a local anesthetic into the surgical bed of~     women operated radical mastectomy for breast cancer for the control of postoperative pain.~      Material and methods: double-blind randomized clinical trial. The investigators recruited~     patients who underwent modified radical mastectomy that met inclusion and exclusion criteria.~     The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours, and saline~     control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local anesthetic~     and rescue medication was identical in both groups.~      Statistical analysis: The baseline patient characteristics of the patients were analyzed by~     Chi square or Student t always meet criteria of normality, otherwise it will use the~     Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse~     events will be held on chi-square test.~   "
166228|NCT01389921|"~     The purpose of this study is to investigate afferent and cortical activities during bladder~     filling under different stimulations of the lower urinary tract. The participants of the~     study are healthy test persons and patients with overactive bladder.~   "
166229|NCT01389908|"~     The purpose of this study is to assess the long-term efficacy of Olanzapine Pamoate (OP)~     Depot in patients diagnosed with schizophrenia or schizoaffective disorder.~   "
166230|NCT01389895|"~     This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose~     study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of~     12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo.~     Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140~     mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of~     Cohort 1 (210 mg) is completed.~   "
166231|NCT01389882|"~     The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist~     (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory~     oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison~     with currently used standard ventilation (synchronized intermittent mandatory ventilation~     with pressure-support ventilation, SIMV+PSV).~   "
166232|NCT01389869|"~     Obesity is closely related to metabolic diseases and its prevalence is sharply increasing.~     However, there is no safe and effective treatment for obesity so far, the investigators need~     a breakthrough idea to curtail the constant threat of obesity. It has been recently~     demonstrated that emotional tears of women can modify sexual responses, one of basic~     instincts, in men. As appetite and food intake is another basic instinct, chemosignals from~     tears and plasma may modify appetite and eating behavior in humans.~   "
166233|NCT01389856|"~     The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled~     nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a~     supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its~     metabolites.~   "
166234|NCT01389843|"~     KorAHF is a multi-center registry (prospective cohort) for acute decompensated heart failure~     patients in Korea.~      The aim of this registry is to analyze several causes affecting prognosis and survival and to~     develop new strategies for managing acute decompensated heart failure.~   "
166235|NCT01389830|"~     Objectives:~      The primary objective of the research project is to investigate how declining health status~     influences the end-of-life (EOL) treatment preferences in Latino Medicare beneficiaries with~     cancer and to examine if and how these preferences are modified by predisposing~     characteristics (i.e., acculturation, education, medical mistrust, perceived racism) and/or~     provider-related characteristics (i.e., ethnicity, language used, provision of interpreters,~     or patient navigators). The specific aims are:~        1. To determine if declining functional status influences the end-of-life treatment~          preferences of older Latino Medicare beneficiaries with cancer.~        2. To determine if predisposing characteristics (i.e., acculturation, age, education,~          medical mistrust, perceived racism) and/or provider-related characteristics (i.e.,~          ethnicity, language used, provision of interpreters, or patient navigators) modify the~          association between end-of-life treatment preferences and declining health status in~          older Latino Medicare beneficiaries with cancer.~        3. To identify if the end-of-life treatment preferences of Latino Medicare beneficiaries~          with cancer differ from those of older Medicare beneficiaries without cancer.~   "
166236|NCT01389817|"~     The overall objective of the proposed research is to test the hypothesis that Near-infrared~     Light-emitting Diode (NIR-LED) therapy will stimulate mitochondrial function, attenuate~     oxidative stress, and improve cell survival and vision in subjects with Leber's Hereditary~     Optic Neuropathy (LHON).~   "
196131|NCT00996151|"~     The study will evaluate the amount of Testosteron MD-Lotion 2% remaining on the axilla after~     a single dose application in healthy males who undergo a post dose washing procedure.~   "
166239|NCT01389778|"~     Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age~     women. Women with PCOS have a high risk of prediabetes, type 2 diabetes and heart disease.~     The investigators have found a possible change in the DNA (genes of the body that encode all~     of our traits) that seems to be related to insulin resistance. In this study, the~     investigators will try to determine whether the change in the gene affects a woman's ability~     to respond to a common treatment for PCOS, metformin.~      These studies will uncover the change in a gene that might be one of the causes of PCOS.~     Discovering this gene will help better understand the diabetes and insulin abnormalities that~     are common in PCOS and will help us to better diagnose and treat PCOS to prevent the diabetes~     in these women.~   "
166240|NCT01389765|"~     This study will evaluate the effect of food on LY2216684. There will be 2 study periods each~     lasting up to 5 days. There will be at least 7 days between the two doses and a follow up~     will occur at least 7 days after the last dose. Screening is required within 30 days prior to~     the start of the study.~   "
166241|NCT01389752|"~     The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2~     occasions, once with activated charcoal and once without activated charcoal.~      The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects~     will be documented. There will be 2 study periods each lasting up to 5 days. There will be at~     least 7 days between the two doses and a follow up will occur at least 7 days after the last~     dose. Screening is required within 30 days prior to the start of the study.~   "
166242|NCT01389739|"~     Many authors have recognized the need to overcome the different barriers to continuity of~     cancer care, such as inadequate communication between specialists and family physicians (FP),~     insufficient information provided for the long-term follow-up care and difficulties to~     transfer back to FP the responsibility for cancer care at the end of treatments. This study~     aims to assess the effectiveness of a multi-faceted intervention to improve continuity of~     care for patients with lung cancer. Newly diagnosed lung cancer patients who have a FP will~     be randomly assigned to either the intervention group or to usual care and they will be~     followed at baseline, 3, 6, 9, 12, 15 and 18 months ( or until death for those with a~     survival of less than 18 months). The intervention comprises 4 components: 1) systematic~     appointments with FP at 3-month interval ; 2) transmission to FP of a standardized~     comprehensive summary before each appointment; 3) systematic transmission to the oncology~     team of patients' information resulting from FP visits; 4) development of a priority access~     to FP for cancer patients. In both groups, outcomes related to patients and to care processes~     will be measured at baseline and then after 3, 6, 9, 12, 15 and 18 months (or until death for~     those with a survival of less than 18months). Patients' principal family caregiver will be~     invited to participate to the study and they will complete questionnaires at baseline, at 6~     months and at the end of the study. In addition, patients' FP will also be invited to~     complete a questionnaire at baseline and at the end of the study.~   "
166243|NCT01389726|"~     This study is a multi-site, four-year long clinical trial study in which several mental~     health interventions will be delivered to custodial grandmothers and then compared. The study~     will examine effects on the mental health of these grandmothers and the grandchildren they~     provide full-time care to in complete absence of the grandchild's birth parents. Grandparents~     from diverse racial, ethnic, and socio-economic backgrounds will be recruited to test for~     cultural differences in response to these interventions. This study is important because~     there is growing evidence that custodial grandchildren are at-risk for psychological~     difficulties due to neglect and abuse by birth parents, challenges to parenting faced by~     custodial grandparents, and limited access to needed services. This study is funded by the~     National Institute of Nursing Research, a division of the National Institutes of Health, and~     it is anticipated that more than 500 custodial grandfamilies in four sites across the United~     States will partake.~   "
166244|NCT01389713|"~     Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent~     a demanding challenge for clinicians. It has classically been claimed that using higher~     dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation~     and increase the chances of success. However, scientific evidence supporting this view is~     scanty and costs are inevitably much higher. In this study, the investigators hypothesized~     that similar chances of pregnancy may be achieved with a mild stimulation using exclusively~     Clomiphene citrate (CC).~   "
166245|NCT01389700|"~     Primary Objective:~      - To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356~     administered to intensive care unit (ICU) patients on mechanical ventilation~      Secondary Objectives:~        -  To determine the safety and tolerability of SAR279356~        -  To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356~        -  Exploratory efficacy of SAR279356 on prevention of bacterial infections~   "
166246|NCT01389687|"~     The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose~     primary and booster vaccination in Japanese infants aged 3 through 68 months.~      Primary objective:~        -  To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90%~          approximately one month following the three dose primary vaccination series with~          inactivated polio vaccine (IPV).~      Secondary objective:~        -  To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine~          response rates and Geometric Mean Titers) of IPV before and after the primary~          vaccination and before and after the booster vaccination.~        -  To describe the safety after each dose of IPV.~   "
166247|NCT01389674|"~     The investigators will check the feasibility of an intraprocedural vitality diagnostics and~     the identification of an indication for Percutaneous transluminal coronary angioplasty~     (PTCA).~   "
166302|NCT01388959|"~     This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of~     MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal~     residual disease after autologous haematopoietic stem cell transplantation (bone marrow or~     peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients~     with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal~     B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2~     intravenously once every week. The anticipated time on study treatment is 4 weeks.~   "
166303|NCT01388946|"~     The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients~     undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the~     analgesic consumption during the first 24 hours.~   "
166248|NCT01389661|"~     This trial pretends to validate for clinical use a bioengineered product composed of MSV~     cells (mesenchymal stem cells produced by IBGM, Valladolid, which have already been approved~     by the Spanish Regulatory Agency for three previous clinical trials) and a cross-linked~     matrix of autologous plasma patented by The Blood and Tissue Bank of Asturias (WO2008/~     119855) for bone maxillary cysts refilling. These two groups collaborate in the present~     project with the team of Maxillofacial Surgery of the Hospital Universitario del Río Hortega,~     who leads the clinical trial and deals with the medical aspects. The proposed trial is based~     on positive results obtained in previous animal studies performed by the present~     multidisciplinary team. The investigators propose a phase I / II clinical trial with 10~     patients suffering from bone cysts in the maxillofacial region. Autologous mesenchymal stem~     cells isolated from a bone marrow sample will be seeded in the autologous plasma matrix and~     cultivated for 3 weeks. At this time, the cyst will be removed by surgery and the cavity~     filled with the protein matrix containing the mesenchymal cells. Checks will be conducted at~     3 weeks, 3 and 6 months following the evolution of the cavity by panoramic radiography and~     computerized tomography scan.~   "
166249|NCT01389648|"~     The purpose of this study is to assess the roll of pre-operative chest physiotherapy, in~     addition to the usual care given after major abdominal surgery, in the prevention of~     post-operative respiratory complications.~   "
166250|NCT01389635|"~     Abdominoplasty is one of the most popular body-contouring procedures, yet it is also among~     the most hazardous aesthetic procedures currently performed. It was shown, in many studies,~     to be associated with a significant complication rate, some of which are life-threatening.~     This study describes the investigators experience with a series of abdominoplasties performed~     under epidural anesthesia. Outcomes are presented, especially in terms of complication, and~     the practical advantages of this method are discussed.~   "
166251|NCT01389622|"~     Auricular acupressure has been practiced in China and Germany to help people in smoking~     cessation programs. The purpose of this clinical trial is to test for the clinical~     effectiveness of self-administered auricular acupressure as a non-invasive method for smoking~     cessation.~   "
166252|NCT01389609|"~     To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water~     to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition~   "
166253|NCT01389596|"~     Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter~     study to evaluate the safety and efficacy of two dose levels of pregabalin administered in~     equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive~     therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.~   "
166254|NCT01389583|"~     A Phase II Study of AUY922, Novel HSP Inhibitor, in Patients with Advanced GIST Failed to or~     Intolerance of Imatinib and Sunitinib Therapy~      Primary endpoint:~      •The primary endpoint of this study is to assess disease control rate (complete response +~     partial response + stable disease≧4 months) of AUY922 in patients with advanced GIST failed~     to imatinib and sunitinib~      Secondary endpoints:~        -  To determinate the objective response rate (ORR, complete response + partial response)~        -  To determinate the time to tumor progression (TTP)~        -  To evaluate the safety and toxicity profiles of AUY922~        -  To evaluate the pharmacokinetics profile of AUY922 in Taiwan GIST population~        -  To access the pharmacodynamic effect of AUY922 on HSP client proteins in blood and tumor~          if feasible , i.e. HSP70, in Taiwan GIST population~        -  To access the tissue biomarkers pre-treatment and 4wks post treatment if feasible, i.e.~          HSP70, c-KIT, PDGFRA mutation, ...etc in Taiwan GIST population~      Exploratory endpoints:~      •PET imaging; sSUVmax~   "
166255|NCT01389570|"~     Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice.~     However, pharmaceutical prophylaxis can confer unpleasant adverse effects. It would therefore~     be appropriate to consider the use of non-pharmacological methods in preventing PONV.~     Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and~     the adverse effects are minimal. Consequently, the aim of the study is to implement~     acupressure in our anaesthetic department procedures. A reduction of the use of antiemetics~     will be a parameter on the effectiveness of acupressure. The study will focus on acupressure~     as a supplement to the ordinary prophylactic treatment of PONV in adults undergoing~     orthopaedic and general surgery, and adults and children undergoing ear, nose, throat~     surgery. The primary endpoints are the quantities of antiemetics used before (baseline) and~     during the implementation period. The study will be conducted from January to December 2011.~   "
166256|NCT01389557|"~     Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping~     malaria transmission. The addition of primaquine (PQ) - the only drug commercially available~     that kills mature transmission stage - to such treatments might be necessary to eliminate~     this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine~     (DHP) regimens with PQ on malaria transmission on a community wide level in Lempasing,~     Lampung, Sumatra.~   "
166257|NCT01389544|"~     This multicenter, open-label study will assess the effect of multiple doses of~     danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable~     methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive~     danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.~   "
166258|NCT01389531|"~     The aim of the study is, primarily, evaluate the safety of the use of the silicone stent~     HCPA-1 in patients with clinically significant tracheal and/or bronchial stenosis.~     Secondarily, this study aims to evaluate the efficacy of the use of the silicone stent HCPA-1~     who are in the same conditions described above and also estimate the costs the use of these~     silicone stents involve.~   "
166259|NCT01389518|"~     The aim of this study is to evaluate the efficacy and safety of a fixed combination of~     paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and~     flu-like illness in adults in a randomized, double-blind, controlled trial. The investigators~     included 146 healthy study subjects aged between 18 and 60 years who presented flu or common~     cold moderate to severe onset of less than 3 days (72 hours). After clinical and laboratory~     evaluation were randomized to receive active drug or placebo, five capsules a day, every 4~     hours for 48-72h.The outcomes to assess the effectiveness involve the measurement of symptom~     scores, overall duration of symptoms, return to usual activities, use of rescue medication,~     improvement of the fever.~   "
166260|NCT01389505|"~     This is a prospective, randomized and comparative study is to quantify the functional and~     structural alterations of the macula in patients with proliferative Diabetic Retinopathy~     submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab~     as a adjuvant therapy in preventing the adverse events of that procedure. The patients with~     proliferative Diabetic Retinopathy (DR) with indication of binocular laser photocoagulation~     will be examined by ophthalmologists who will measure the visual acuity and contrast~     sensitivity, perform slit lamp examination, fundus examination and optic coherence tomography~     before and after laser photocoagulation. Laser photocoagulation will be performed in both~     eyes according Early Treatment Diabetic Retinopathy Study that advocate the realization of 3~     episodes of laser photocoagulation in 3 weeks. This comparative study analyses the effect of~     intravitreal bevacizumab one week before laser photocoagulation and one, three and six months~     after the randomization visit. The fellow eye will be submitted only to laser~     photocoagulation and will be considered as control. It is estimated a sample of 30 patients.~     All procedures, purposes and methods will be explained to all patients.~   "
166261|NCT01389492|"~     The postprandial increase in MDA level following meat meal could cause modification to LDL~     particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat will~     result in a significant decrease in LDL modification.~   "
166262|NCT01389479|"~     The purpose of the study is to evaluate the safety, tolerance and immunogenicity of Fluviral™~     in healthy adults aged 18-64 years.~   "
166263|NCT01389466|"~     This study was designed in two steps with Step 1, a single-center, double-blind, randomized~     clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal~     study. The investigator evaluate the immunogenicity and safety of the investigational vaccine~     in the subjects during their participation in the study.~   "
166264|NCT01389453|"~     All experimental group patients of 100 patients accept a treatment course stem cell~     transplantation, including one time stem cell transplantation through intravenous injection~     way at the 10-21th day of cerebral hemorrhage, and the 7—14th day of cerebral infarction~     incidence; the second time transplantation through lumbar puncture way at the 7th day after~     the First time transplantation. The control group gives injection through intravenous and~     lumbar puncture ways separately in the corresponding time, but the transplantation matter is~     physiological saline not the stem cell.~   "
166265|NCT01389440|"~     This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of~     Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by~     gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy /~     day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to~     assess the percentage of R0 resections. They have planned a total of 21 visits.~   "
166266|NCT01389427|"~     This is a multicenter, open label, three arms, Phase IB study.~      A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day 2,~     day 8 and day 15 in combination with three chemotherapies regimens for patients in~     relapsed/refractory Mantle Cell Lymphoma (MCL):~        -  Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered~          every 3 weeks for 6 cycles,~        -  Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks for 6 cycles,~        -  Rituximab-Aracytine high dose-Dexamethasone (R-DHA) administered every 4 weeks for 6~          cycles.~   "
166267|NCT01389414|"~     This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of~     panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX).~     Eligible subjects will be enrolled and randomized to receive first-line combination therapy~     consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame~     of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX)~     combination compared to GEMOX alone in patients with previously untreated surgically~     unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the safety~     profile of the P-GEMOX combination; to assess the objective response rate; to assess overall~     survival; to study the correlation between biomarkers with activity and efficacy.~   "
166268|NCT01389401|"~     -  Saliva plays a key role in the homeostasis of the digestive tract~        -  The reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal~          and pharyngeal mucosas~        -  There seems to be no correlation between the severity of reflux episodes and the~          intensity of inflammatory changes, suggesting individual protective mechanisms to~          refluxate exposure~        -  Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux~          Disease (GERD) and its supraesophageal manifestations, especially reflux laryngitis~          (Laryngopharyngeal Reflux- LPR)~        -  Decreased salivary Epidermal Growth factor (EGF) concentrations have been found in~          patients with GERD and LPR, but it is unclear if these are primary or secondary to the~          disease.~        -  Hypothesis: The decreased salivary EGF concentrations in patients with reflux laryngitis~          is primary and therefore would not change after treatment and control of the disease~   "
166269|NCT01389388|"~     Patients with rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) are at greater risk~     of developing cardiovascular disease. The reason(s) for this have not been well investigated,~     but there is a general understanding that systemic inflammation plays a part in the increased~     cardiovascular morbidity and mortality. In spite of the increased risk in these patients,~     they have not been included as a high risk patient group in cardiovascular prevention~     guidelines.~      The investigators have carried out a cardiovascular study of RA and AS patients, as well as~     patients with arthritis for the first time. The investigators have demonstrated cholesterol~     plaques in the carotid artery in some of these patients. Plaques in the carotid artery~     represent a risk for development of cerebral stroke and are significantly associated with~     myocardial infarction. These plaques, which are asymptomatic and do not cause~     haemodynamically significant narrowing, diameter reduction (i.e. operation is not indicated),~     are vascular atheromatous disease. Therefore, according to prevailing cardiovascular~     guidelines (SCORE 2007), these patients shall have secondary prevention with a lipid lowering~     agent with the LDL-cholesterol goal of 1.8 mmol/L and HDL-cholesterol > 1.0 mmol/L for men~     and > 1.1 mmol/L for women.~      Statins are cholesterol-lowering drugs, and have been shown to reduce the risk of~     cardiovascular disease significantly. In addition, reduction in the size of coronary plaques~     has been induced by statins, when the LDL has been reduced to 1.6-1.8 mmol/l. Plaques in the~     carotid or coronary arteries have not previously been treated and characterized in patients~     with RA, AS and other inflammatory forms of arthritis.~      The aim of this study is to treat patients with cholesterol plaques in the carotid artery~     with cholesterol-lowering medication, in the form of Rosuvastatin for 18 months, and~     characterize the effects on the plaques in the carotid and coronary arteries. In addition,~     the investigators want to clarify the connection between plaques in the carotid and coronary~     arteries in patients with RA, AS and other inflammatory forms of arthritis.~   "
166270|NCT01389375|"~     Are novel vascular closure devices noninferior to manual compression regarding access site~     complications after coronary angiography?~   "
166304|NCT01388933|"~     The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the~     treatment of Crohn's disease.~   "
166271|NCT01389362|"~     There is now a global epidemic of diabetes and obesity affecting more than 300 million people~     worldwide with Asia in the forefront. In Hong Kong, diabetes affects more than 10% of the~     population. Patients with diabetes have a 12—25% lifetime risk of developing a foot ulcer.The~     abnormal metabolic milieus of hyperglycemia, hyperlipidemia, hypertension, pro-thrombotic~     state and chronic inflammation in diabetes causes atherosclerosis.A significant proportion of~     subjects have underlying peripheral arterial disease and neuropathy. These subjects are at~     great risk of developing infective foot ulceration secondary to impaired vascular supply,~     sensory loss and minor trauma.Without prompt and proper medical treatment, these infective~     ulcers will deteriorate leading to gangrene and limb amputation. In-vitro and in-vivo studies~     revealed that 5 out of the 12 herbs were effective in promoting fibroblast proliferation and~     angiogenesis. To minimize potential drug interactions and adverse effects from multiple~     components in a recipe of Traditional Chinese Medicine (TCM), the investigators have~     developed a simplified formula from the 12 herbs consisting of only two herbs. In this~     proof-of-concept study, the investigators hypothesize that the novel recipe of herbal~     medicine will expedite healing of early foot ulcer by promoting vascularisation and~     granulation as well as modulating inflammatory response.~   "
166272|NCT01389349|"~     Pain after tonsillectomy can be severe and last ten days.~      Various new surgical instruments have been developed over the years in an attempt to reduce~     postoperative pain with mixed results and increased costs; no single tonsillectomy technique~     is superior to the rest. Patients are discharged to home usually on the day of surgery and~     often suffer significant pain and nausea. Pain medication is often prescribed which can cause~     nausea, vomiting and constipation. Children in pain are reluctant to take in fluids and may~     require intravenous hydration at an emergency department.~      Battlefield acupuncture  has been recently developed by the US Air Force and is now being~     used in Iraq and Afghanistan on wounded warriors suffering severe acute pain from trauma.~     This protocol consists of five acupuncture points on the outer ear.~      A recent study has demonstrated decreased pain and agitation in children undergoing ear tube~     insertion. Ear tube patients have mild discomfort compared to tonsillectomy patients and are~     able to attend school the next day.~      The investigators have been encouraged by the benefits of acupuncture during surgery for ear~     tube patients and also wounded warriors recovering from their injuries. These findings~     motivated us to see if acupuncture during tonsillectomy surgery would result in less pain and~     nausea.~   "
166273|NCT01389336|"~     The aim of this study is to evaluate the effectiveness of an additive complex āyurvedic~     diagnosis and treatment compared to conventional standard care alone in stationary patients~     with Fibromyalgia Syndrome.~   "
166274|NCT01389323|"~     The purpose of this study is to compare the rates of sustained virologic response in each~     cohort (Black-African Americans, Latinos) in this study to historical rate.~   "
166275|NCT01389310|"~     The purpose of this study is to monitor adverse events in HIV-infected children <18 years old~     who are exposed to Atazanavir in a real-world setting in Europe.~   "
166276|NCT01389297|"~     The objective of this research project is to develop, evaluate, and disseminate an~     Internet-based (web) application for SMART Recovery: Overcoming Addictions (OA). OA will be~     based on the four point cognitive-behavioral program for SMART Recovery~     (www.smartrecovery.org). The goal of the OA program is to help users learn cognitive and~     behavioral skills to abstain from drinking, drug use, and problem gambling.~      The investigators will evaluate the effectiveness of the OA web application for heavy~     drinkers in a randomized clinical trial (RCT) with follow-ups at 3- and 6-months.~      The study design has three conditions: 1) participation in face-to-face SMART Recovery~     meetings alone; 2) use of the OA web application as a stand-alone intervention; and 3)~     combining the OA web application with participation in face-to-face SMART Recovery meetings.~      Study Hypotheses:~        1. All three groups will reduce their alcohol consumption, drug use (if any), and~          alcohol/drug-related problems relative to their baseline levels at the 3- and 6-month~          post-baseline assessments.~        2. The OA only group (Experimental group 1) will show a greater reductions in drinking,~          drug use (if any), and alcohol/drug-related problems relative to the face-to-face only~          (Control) group.~        3. The OA + face-to-face group (Experimental group 2) will have better outcomes on drinking~          and drug use variables compared to the Control group.~   "
166277|NCT01389284|"~     The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg~     tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with~     postsurgical dental pain.~   "
166278|NCT01389271|"~     This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in~     the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with~     primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial~     hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class~     and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and~     tolerability of the drug and the survival of the patients will be observed.~   "
166279|NCT01389258|"~     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 3mm~     diameter implant in a Chinese population by evaluation of marginal bone level alteration,~     implant stability and implant survival in the posterior maxilla up to 3 years after loading.~     Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.~   "
166280|NCT01389245|"~     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX implants~     in a Chinese population by evaluation of marginal bone level alteration, implant stability~     and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early~     loading of the posterior maxilla is a safe and predictable procedure.~   "
166281|NCT01389232|"~     This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in~     breast reconstruction surgery.~   "
166282|NCT01389219|"~     Introduction of a community-based intervention package including prevention strategies, early~     recognition and management of common postpartum & neonatal problems, as well as prompt~     referral of high risk/complicated cases through trained first level primary health care~     workers, will result in a significant reduction in Postpartum maternal and neonatal mortality~     in Pakistan~   "
166283|NCT01389206|"~     Knowledge Translation Program for the guidelines and evidence-based management of PAH~     patients~   "
166284|NCT01389193|"~     This will be a double-blind, randomised, placebo-controlled, two period cross over study of~     ibudilast in the treatment of chronic migraine.~      For participants resident in Adelaide, South Australia (i.e. local participants):~      The study will involve a screening visit followed by eight visits to the Pain and Anaesthesia~     Research Clinic (PARC), within the Royal Adelaide Hospital (RAH), for baseline testing,~     initiation of the study medications and ongoing data collection (one baseline and three study~     visits during each treatment period).~      At the baseline visit, blood samples to assess biomarkers (glutamate, calcitonin gene-related~     peptide, glial fibrillary acidic protein and S100β) will be taken. Patients will then be~     randomised (in a 1:1 ratio) to commence either ibudilast or placebo treatment, which will~     continue for 8 weeks. Subsequently participants will undergo a 4-week washout period. At the~     end of the washout period a second 8-week treatment block with the alternative treatment will~     commence.~      Patients will complete a headache diary daily for at least 4 weeks prior to the baseline~     visit, throughout the treatment and washout periods and for 4 weeks after treatment ceases.~     The diary will record headache frequency, duration, intensity, pain characteristics and~     medication intake for comparison with baseline data.~      From screening until the final study visit (over a minimum of 6 months) a total of~     approximately 200 mL in blood samples will be taken from each local participant.~      For participants located in country or interstate locations:~      The same study will be undertaken, but instead of attending the Pain and Anaesthesia Research~     Clinic (PARC), within the Royal Adelaide Hospital (RAH) for screening and study visits, these~     will be managed remotely through:~      basic input from the participant's GP during the screening period correspondence with the PI~     and study staff via registered post, phone or Skype scheduled visits to the nearest pathology~     collection centre for blood biochemistry and haematology analysis~      Interstate or country participants will also be exempt from collection of blood samples for~     biomarker analysis, hence a total of approximately 120 mL of blood samples will be taken from~     each interstate or country participant.~   "
166285|NCT01389180|"~     This study will provide critical data regarding the efficacy for reducing drug-and~     sex-related HIV transmission risk behaviors, as well as improving methadone maintenance~     treatment (MMT) outcomes and patient functioning of two transportable counseling models,~     behavioral drug and HIV risk reduction counseling (BDRC) and educational counseling (EC) as~     compared with the current standard of care model in MMT in China. Evidence-based counseling~     that is efficacious in reducing HIV risks and drug use and is feasible to provide with MMT~     will greatly improve the public health benefits of disseminating MMT in China and elsewhere~     in the world.~   "
166286|NCT01389167|"~     The long-term goals of this study are to foster development and dissemination of~     evidence-based behavioral and pharmacological treatments to reduce HIV transmission,~     injection drug use (IDU), and heroin use in Russia. This study will examine the effects of~     combining behavioral therapy with naltrexone pharmacotherapy for the treatment of opiate~     dependence and reduction of HIV risks in opiate dependent individuals. Specifically the study~     will determine whether extended-release injection naltrexone has greater efficacy and is more~     cost-effective than oral naltrexone maintenance, whether behavioral drug and HIV risk~     reduction counseling (BDRC) combined with brief, medical management (MM) has greater efficacy~     and is more cost-effective than MM only, and whether particular combinations of medication~     formulation and counseling (MM only or MM plus BDRC) have greater efficacy or are more~     cost-effective than other combinations.~   "
166287|NCT01389154|"~     The objective of the prospective, multi-center study is to evaluate the ease of use and~     effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a~     method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and~     beyond the bronchus. Measures of diagnostic yield will be compared to the diagnostic yield of~     similar published historical controls using conventional bronchoscopy.~   "
166288|NCT01389141|"~     The investigators hypothesize that age-related changes in the number and growth dynamics of~     ovarian follicles will be associated with changes in hormone levels and corresponding changes~     in musculoskeletal health.~   "
166289|NCT01389128|"~     The proposed project will be conducted to evaluate the influence of application resources~     associated with non-pharmacological during labor for pain relief and accelerated phase of~     expansion. Although mothers' access to resources for non-pharmacological pain relief during~     labor is recommended, is not seen as the application of routine obstetric practice, although~     it has been demonstrated benefits and scientific evidence with your application. It is~     believed that the implementation of this protocol based on the application of~     non-pharmacological resources in assisting the labor can be introduced into daily practice in~     various hospitals in the country, minimizing pain and favoring the shorter duration of labor,~     decrease in use of painkillers and inductors, resulting in a reduction of complications,~     improves the comfort of the mother making her birth experience more satisfying and rewarding,~     being assisted with security and trained by multidisciplinary teams.~   "
166290|NCT01389115|"~     The purpose of this study is to determine lipid metabolism in chronic liver disease in the~     attempt to find a useful biomarker of liver function and of prognostic value of graft~     function in those patients who undergo liver transplant. The present study enrolls subjects~     with liver cirrhosis (with different ethiology), including subjects eligible for a full-size~     liver transplantation, and healthy controls.~   "
166291|NCT01389102|"~     Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in~     postmenopausal women. This study will evaluate the safety and efficacy of Evamist.~   "
166292|NCT01389089|"~     Edema control after ankle- and hindfoot fractures is important. Multi-layer compression~     bandages or A-V Impulse compression may are more effective in reducing edema than ice.~   "
166293|NCT01389076|"~     Patients with a type of non-Hodgkin lymphoma, called follicular lymphoma and have not yet had~     previous systemic treatment, such as chemotherapy or immunotherapy will be invited to~     participate. This research study is being conducted in order to evaluate the combination of~     lowdose methotrexate and Iodine I 131 tositumomab (Bexxar) with regards to whether the~     combination will reduce the occurrence of the HAMA (Human Anti-Mouse Antibody) response. HAMA~     is an immune reaction against the tositumomab protein. Symptoms arising from HAMA can range~     from a mild form, like a rash, to a more extreme and possibly life-threatening level. HAMA~     can also decrease the effectiveness of the treatment, or create a future reaction if a~     patient is given another treatment containing mouse antibodies. In addition to evaluating the~     occurrence of HAMA, this research study will also look at the short and long-term~     effectiveness of this combination in the treatment of lymphoma, as well as its safety.~   "
166305|NCT01388920|"~     A significant proportion of COPD subjects experience muscle wasting, which has been~     associated with increased morbidity, impaired physical functioning, and a poor quality of~     life.~      Muscle wasting is associated with reduced muscle strength in COPD subjects. In particular,~     weakness of peripheral muscles has been reported to play an important role in the reduced~     functional capacity and impaired exercise performance.~      The primary objective of this study is to investigate the effect of tesamorelin, in~     conjunction with exercise training, on lean body mass measured by dual energy x-ray~     absorptiometry (DXA) scan.~   "
166294|NCT01389063|"~     HIV infected patients treated with abacavir might have a higher risk for the occurrence of~     cardiovascular events. At time of writing of this protocol the underlying mechanism is not~     yet elucidated, however some studies find impaired endothelial function and elevated markers~     of chronic inflammation in these patients,suggesting a higher lever of chronic inflammation.~     Recently maraviroc (Celsentri®), a CCR5-receptor antagonist, became available for treatment~     of patients infected with HIV-1.~      Improvement of endothelial function may be a potential beneficial side effect of treatment~     with maraviroc, due to the potential reduction of immune activation and chronic inflammation~     as a result of blocking the CCR5-coreceptor. Moreover, treatment intensification of HAART~     with maraviroc in patients with suppressed plasma HIV_RNA may decrease plasma HIVRNA below~     the cut-off of 50 copies/ml as well.~      The investigators hypothesize that maraviroc intensification therapy in patients on an~     abacavir-containing regimen will improve endothelial function.~      The objectives of this study are: First, to assess the effect of addition of maraviroc to an~     abacavir-containing regimen on endothelial function; second, to assess the effect of this~     intervention on markers of immune activation and chronic inflammation, and on plasma HIV-RNA~     below 50 copies/ml.~   "
166295|NCT01389050|"~     This research study aims at defining 1) how retroperitoneal sarcomas change over the course~     of radiotherapy and 2) how radiotherapy affects your well-being. While the investigators know~     that radiotherapy before surgery is safe and effective, the amount of tumor motion and size~     change during radiotherapy is unknown. There is also very little information that describes~     the side-effects of radiotherapy in the treatment of this disease.~   "
166296|NCT01389037|"~     This clinical trial focuses on helping African Americans with high blood pressure to manage~     their disease. The study will target their ability to read and understand health information~     (also called health literacy). The research method relies on community participation in equal~     partnership with the researchers to provide interactive workshops and home blood pressure~     self-monitoring with the assistance of telephone counseling by community health workers.~   "
166297|NCT01389024|"~     This is a pilot study of hydroxyurea versus placebo to reduce central nervous system~     complications (abnormally fast blood flow to the brain, silent cerebral infarct or stroke) in~     young children with sickle cell disease. The investigators plan to identify children 12 to 48~     months old without central nervous system complications and randomly assign 20 to treatment~     with hydroxyurea and 20 to treatment with placebo for 36 months. Neither the study doctors~     nor the participants will know which treatment they are receiving.~   "
166298|NCT01389011|"~     The purpose of this study is to:~        1. To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth~          variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after~          induction of general anesthesia.~        2. To compare effects of fluid-bolusing on PI and PVI of the anesthetized and~          non-anesthetized limb.~   "
166299|NCT01388998|"~     Fluid therapy optimization in the perioperative period has been considered as major~     contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid~     requirements in the anesthetized patient with arterial line is the assessment of difference~     in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid~     management approach to avoid both hypervolemia and hypovolemia. However, several clinical~     factors may impede dPP measurements. Surgical manipulations in abdominal procedures may~     interfere with hemodynamic stability due to obstruction of the caval vein. Physiological~     considerations make us hypothesize that only intense pressure impedes caval blood flow and~     thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after~     standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval~     vein.~   "
166300|NCT01388985|"~     Rabies is a viral zoonosis that causes an encephalitis, almost invariably fatal. It is widely~     distributed across the globe: the World Health Organization (WHO) estimates that about 2,4~     billion people live in endemic areas for canine rabies. Vaccination of domestic animals is~     limited to industrialized and middle-income countries.~      The development of clinical rabies can be prevented through timely immunization after~     exposure: however, preventive vaccination simplifies the post-exposure procedure~     considerably, as immunoglobulins are no longer needed and less vaccine administrations are~     scheduled. Pre-exposure prophylaxis consists of an intramuscular (IM)of intradermal (ID) dose~     given on days 0, 7 and 21 or 28. The development of immunological memory after this~     vaccination is critical for the establishment of long lasting immunity. Subjects receiving a~     booster dose 1 year after pre-exposure prophylaxis segregate themselves into 'good' and~     'poor' responders; the former may not need further boosters for 10 years, whereas the latter~     may need more frequent boosters.~      Until recently, guidelines in travel medicine recommended pre-exposure vaccination only for~     some risk groups. Since recent studies have shown the effectiveness of the ID vaccination,~     the policies are changing towards pre-exposure vaccination for a larger population, including~     travelers to endemic regions, where immunoglobulins and vaccine are often not readily~     available.~      Based on the above, the investigators must stress the concept of boostability after a risk~     exposure. However, the current pre-exposure vaccination scheme could be improved: a schedule~     of 1 week would be less time consuming, would improve compliance and give less interference~     with other prophylaxis measures, e.g. mefloquine. Two small studies suggest that a schedule~     of 1 week interval is as effective and immunogenic as the standard one.~      The investigators will investigate whether the accelerated schedule is as effective as the~     classical schedule, by carrying out a randomized, non-inferiority study.~   "
166301|NCT01388972|"~     Several environmental factors have contributed to the growing pandemic of obesity. It has~     been described that some characteristics of food and built environment have an influence on~     patterns of food consumption and physical activity of people in a certain place.~      We have designed a cross-sectional study to describe some aspects of the food environment~     (community and consumer) and the frequency, distribution and characteristics of the space~     available to perform physical activity in three neighborhoods of Buenos Aires city.~      Three neighborhoods of Buenos Aires (with representativity), from different socioeconomic~     strata, will be selected by convenience to conduct this study.~      The study will consist on three stages: first, the generation of the sampling frame of food~     stores, public and private spaces available for carrying out physical activity, and the~     development of a tool designed to evaluate the availability of healthy foods in supermarkets~     and grocery stores. Finally, a sample of those stores will be randomly selected for assessing~     the availability of selected foods.~      In Argentina, the knowledge of the food environment is limited. We believe that the~     information obtained in this study will contribute to a better understanding of the subject.~   "
166306|NCT01388907|"~     The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the~     prevention of adhesions in gynaecologic surgery, and to assess post-operative complications~     related to adhesions and pregnancy rate after myomectomy by open surgery.~   "
166307|NCT01388894|"~     Patients who report that exposure to bright light or strenuous physical activity will induce~     migraine aura will be provoked using one or both of these methods. Followingly the patients~     will be examined by functional MRI. Íf the patients develop migraine headache, MR angiography~     will be performed as well. The primary study hypothesis is that the functional MRI signal~     will show features similar to those of the electrophysiological phenomenon of cortical~     spreading depression.~   "
166308|NCT01388881|"~     The main objective of this study is to evaluate the effectiveness of music education over a~     period of five months (three times per week, one hour per day) on the improvement of reading~     skills (decoding, prosody and phonological awareness) in children (8-10 years) with reading~     difficulties from poor neighborhoods in the city of Sao Paulo. A second objective is to~     develop a theoretical model that may explain how acquired musical skills are correlated with~     the supposed changes in each of the covariates and outcomes in this study.~      The study will be administered to 270 children with reading difficulties from 10 different~     schools (27 children per school). 135 children will have music lessons and 135 will not;~     therefore, 5 schools will be the control and 5 schools will be the intervention group. The~     analysis will consider the cluster structure, since the randomization was not conducted at~     the individual level (i.e., the school level was the randomization unit). For the inferential~     analysis, generalized estimation models and structural equation modeling will be used.~   "
166309|NCT01388868|"~     The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery~     is essential for intraoperative motor-evoked potential monitoring. However, the precise~     strategy of administering neuromuscular blocking agent for obtaining that goal has not been~     established. Therefore, the investigators tried to find the optimal initial dose of~     vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by~     neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).~   "
166310|NCT01388855|"~     The purpose of this study is to determine if the methods are feasible for a larger clinical~     trial.The study will examine the relationship between vitamin D status, quality of life, pain~     and walking distance of individuals living with heart failure.~   "
166311|NCT01388842|"~     The purpose of this study is to assess if adding inhaled Nitric Oxide to other malaria~     treatments can improve the outcome of cerebral malaria in children aged 2months to 12 years.~   "
166312|NCT01388829|"~     This study is designed to compare the pharmacokinetics of two different lots of tablets.~   "
166313|NCT01388816|"~     The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in~     elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein~     cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for~     heart disease.~   "
166314|NCT01388803|"~     A retrospective study to demonstrate the optimal depth of right side bronchial blocker for~     complete right lung separation. Data were collected from all patients who completed right~     side VATS with right side BB from Jan 2010 through Nov 2010.~   "
166315|NCT01388790|"~     This open-label, single-arm, multicenter, Phase 2 trial will treat at least 40 participants~     with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal~     junction (GEJ) who have not previously received systemic chemotherapy for this setting.~      All eligible participants will receive the combination of cetuximab plus S-1 (a combination~     of tegafur, gimeracil, and oteracil) and cisplatin.~   "
166316|NCT01388777|"~     Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and~     destroy cancer tissue.~      The goal of this clinical research study is to learn about the level of effectiveness of~     using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of~     this procedure will also be studied.~   "
166317|NCT01388764|"~     The purpose of the study is to assess the safety, tolerability, and effects of L-Arginine on~     muscles in boys with dystrophinopathy on corticosteroids. Specifically, to see if L-arginine~     reduces muscle signal abnormalities on MRI done pre and post 30 days of L-arginine~     administration.~   "
166318|NCT01388751|"~     Do patients that night splint for 1 month after 6-8 weeks of continuous splinting for a~     mallet injury have the same extensor lag 4 months after initiating treatment as patients that~     do not perform night splinting?~      Secondary Question: Is night splinting a predictor of DASH score or patient satisfaction (on~     a 5-Point Likert scale)?~   "
166319|NCT01388738|"~     Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's~     very important to choose the right way of the management of the patient and an appropriate~     drugs.~      There is a large number of the so-called neuroprotective drugs, which were effective in~     laboratory, but didn't show positive results in clinical studies with using traditional~     clinical scales scores as a primary outcome measures.~      Specialists suggest, that the investigators could receive better results if the investigators~     change design of the studies, particularly if the investigators select more precise and~     sensitive method of assessment.~      Aim of this study: to determine the role of navigated brain stimulation (NBS) for evaluation~     of the changes in the motor centers and motor tracts after administration of different~     cerebroprotective drugs. (The substances won't be compared to each other).~   "
166320|NCT01388725|"~     The purpose of this study is to describe the value of serum sTREM (soluble triggering~     receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP)~     concentrations, white blood cell (WBC) count and SOFA score during sepsis and their clinical~     informative value in predicting outcome.~   "
166332|NCT01388569|"~     RATIONALE: Studying samples of blood from patients treated with sargramostim in the~     laboratory may help doctors learn more about the effects of sargramostim on cells. It may~     also help doctors understand how patients respond to treatment.~      PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV~     melanoma previously treated with sargramostim.~   "
166388|NCT01387841|"~     -  This randomized controlled three arm study compares the effects of a yoga intervention~          with jacobsons progressive muscle relaxation training and only standard of care in~          chemotherapy naive cancer patients.~        -  This study will also assess the neurophysiological correlates of nausea and vomiting and~          assess if effects of intervention on nausea and vomiting outcomes are mediated by~          changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic~          function and sympathetic skin response) or self reported anxiety.~   "
166321|NCT01388712|"~     The most common cause of children chronic constipation is functional disorders. Functional~     constipation is diagnosed after excluding organic causes of constipation (anatomical,~     neurological, endocrinological) and identification of two symptoms defined by the Rome III~     criteria. There could be low number of bowel movements (below three times a week), defecation~     pain, fecal incontinence (once a week), stool consistency or occurrence of large diameter~     stools. The treatment is change of diet, defecation training and application of laxatives.~      The probiotics are defined as living microorganisms, which provided in a proper doses should~     result in beneficial effect on a host health. The assessment of its characteristic is related~     to strain of bacteria affiliation.~      Taking into the consideration that patients with constipation may experience microflora~     intestine disorders, using the probiotics can have the positive impact on process of treating~     this disease. The additional reason for using the probiotics during the constipation~     treatment is an influence of probiotics on movement of the alimentary canal.~      In spite of proved effectiveness of some probiotics' strains further research are required,~     because clinical significance is ambiguous and the effect is confirmed among patients with~     short medical history. That's way the further analysis of probiotic Lactobacillus reuteri DSM~     17938, which was successful treatment method of chronic constipation amongst children~     (infants) should be performed.~      The primary aim of the study is the assessment of Lactobacillus reuteri DSM 17938 efficacy,~     provided with macrogol (Forlax), as treatment of constipation in 3-7 years old children. The~     baseline of estimation is the frequency comparison of bowel movement in children belonging~     into two groups: Lactobacillus reuteri treatment and placebo.~      The secondary aim of the study is the assessment of frequency the additional symptoms~     connected with defecation disorders: such as: number of pain episodes during defecation, the~     intensity of pain, number of hard stools, number of fecal incontinence per week, number of~     macrogol (Forlax) pockets used.~      The investigators believe that constipation treatment (laxatives- macrogol) with~     Lactobacillus reuteri has better efficacy that the same treatment without Lactobacillus~     reuteri in 3-7 years old children with medical history of chronic constipation.~   "
166322|NCT01388699|"~     Recently, there is evidence that endothelial activation and dysfunction are associated with~     migraine, especially in female migraineurs with aura. Our objectives were to determine~     whether novel endothelial function markers are altered in female migraineurs with aura~     compared to age-matched controls.~   "
166323|NCT01388686|"~     Structured web-based survey in selected hospitals with intensive care units in Berlin-~     Brandenburg to collect data on the overall number of blood cultures (used) and the prevalence~     of (positive blood cultures in patients with) CVC - associated sepsis.~   "
166324|NCT01388673|"~     The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational instrument~     indicated for endoluminal trans-oral tissue approximation and ligation in the~     gastrointestinal tract. This study explores the specific application of tissue apposition in~     dilated post-surgical gastric anatomy such as observed in a dilated Roux-en-Y Gastric Bypass~     (RYGB) pouch.~      The primary objective of this study is to perform an evaluation of the safety of the ACE~     Stapler for the treatment of dilated post-surgical gastric anatomy.~      The secondary objective of this study is to evaluate the preliminary efficacy of the ACE~     Stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up~     period.~   "
166325|NCT01388660|"~     This is a randomized, open-label, single-dose, two-sequence, two-period crossover study to~     investigate the pharmacokinetics between a tablet containing 75 mg of Clopidogrel and 100 mg~     of Aspirin and the simultaneous administration of the separate formulations of the two drugs~     in healthy male volunteers.~   "
166326|NCT01388647|"~     This study will evaluate the safety and efficacy of eribulin in combination with carboplatin~     and trastuzumab in the neoadjuvant setting in subjects who are human epidermal growth factor~     receptor (HER)2 positive and are clinically stage IIA to IIIB.~      The study regimen will be administered every 3 weeks for a total of 6 cycles followed by~     definitive surgery.~   "
166327|NCT01388634|"~     The aim of the present study was to analyse factors associated with prolonged length of~     hospital stay, readmission and death in a nationwide group of patients undergoing elective~     ventral hernia repair in search for areas of interest to improve outcome after ventral hernia~     surgery~   "
166328|NCT01388621|"~     The purpose of this trial is to estimate the therapeutic efficacy of the experimental~     targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin and~     either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective standard~     combination in patients with a KRAS wildtype with platinum-sensitive recurrent ovarian~     cancer. It is expected that the progression free survival rate at 12 months is improved by~     the targeted regimen.~   "
166329|NCT01388608|"~     Data on activities of daily living in patients with rheumatoid arthritis are assessed mainly~     be the health assessment questionnaire (HAQ). The HAQ generates data by subjective variables.~     It would be desirable and advantageous to add objective tools reflecting patients' activities~     to the outcome parameters in rheumatoid arthritis. The StepWatch™ activity monitor (SAM) in~     an ankle worn step counter and an accurate instrument to measure real world ambulatory~     activity. The investigators purpose was to investigate whether activities of daily living~     measured by SAM increase during a therapy with the TNF-alpha inhibitor etanercept in patients~     with active rheumatoid arthritis (RA).~   "
166330|NCT01388595|"~     Allergic rhinitis is an under diagnosed global health problem which affects up to 25% of the~     population worldwide. It has been reported as being one of the 10 most common causes for~     attendance to primary care clinics. It is clinically defined as a symptomatic disorder of the~     nose induced by an IgE mediated inflammation following allergen exposure of the membranes~     lining the nose and is characterized by varying combinations of nasal symptoms including~     sneezing, nasal blockage, rhinorrhoea and itching. Intra nasal corticosteroids form the~     cornerstone of anti-inflammatory therapy in allergic rhinitis and there is increasing~     interest in the role of intranasal beta 2 agonists in the management of allergic rhinitis.~     The question therefore arises as to whether salmeterol exhibits such synergistic activity in~     the nose in terms of potentiating the steroid response of fluticasone.~   "
166331|NCT01388582|"~     The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl~     estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or~     Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant~     growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly~     assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or~     identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS.~     All women will be offered nonhormonal contraceptives prior to randomization. The pairs will~     then be followed for four weeks. During this follow-up period, breast-milk intake will be~     quantified by administering deuterium oxide to exclusively breast-feeding mothers and~     measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known~     as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric~     measurements will be collected -- both as a value necessary to implement the breast-milk~     quantification method, as well as an outcome for analysis, and a daily diary will be kept by~     the women participating in the study that records infant feeds and diaper changes.~   "
166333|NCT01388556|"~     Exercise is often noted as an important component in a comprehensive approach to the~     management of Parkinson disease (PD). Most studies of exercise have examined the effects of~     short-term interventions and have tested participants on their anti-Parkinson medications. As~     such, these studies have not been able to determine whether or not exercise may have a~     disease-modifying effect in people with PD. The investigators recent work has shown the~     potential benefits of dance as a form of exercise for individuals with PD, but, like previous~     work, has only examined short-term interventions. The investigators think that dance may be~     ideally suited for study over a longer period of time because dance incorporates many of the~     features recommended for inclusion in PD-specific exercise programs in a format that is known~     to be engaging and to enhance motivation to participate in healthful behaviors. As such, the~     investigators aim to determine both the short- and long-term effectiveness of a~     community-based dance program for individuals with Parkinson disease and to determine how~     physical function changes over time in individuals with PD who do not exercise as compared to~     those who exercise regularly. The investigators hypothesize that:~      A) participation in dance will result in improved physical function, cognitive function, mood~     and quality of life in people with PD within 3 months,~      B) additional improvements will be noted at 6 months as compared to 3 months,~      C) improvements will be maintained at one year with continued, regular participation in a~     dance class,~      D) those who do not exercise will show significant functional decline over a period of one~     year, a decline that will not be present in those who dance regularly.~   "
166334|NCT01388543|"~     This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5~     (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people~     with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to~     people with the normal metabolizing genotype.~   "
166335|NCT01388530|"~     This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and~     feasibility of trigeminal nerve stimulation (TNS) as a treatment for~     Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory,~     pilot study will provide a basis for a federal grant application and larger controlled~     trials.~   "
166336|NCT01388517|"~     Pityriasis alba (PA) is a frequent cause of consultation in tropical areas due to its chronic~     course, trend to relapse and aesthetic impact. Currently, no treatment is widely accepted.~     The objective is to assess the calcitriol and tacrolimus ointment efficacy in the treatment~     of PA compared with petrolatum. Twenty lesions on the face greater than 3 cm, in individuals~     of phototype IV-V, aged 3-18 years are going to be randomly assigned to receive petrolatum,~     calcitriol, and tacrolimus twice daily. No photoprotection is going to be indicated, and~     hygienic habits will not be modified. Patients will be evaluated at baseline and for 9 weeks,~     by means of Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography~     control.~   "
166337|NCT01388504|"~     The research question to be addressed is Does a 2.5 - 5 minute systemic intravenous~     injection of sodium nitrite administered immediately before opening of the infarct related~     artery result in significant reduction of ischaemia reperfusion injury in patients with first~     acute ST elevation myocardial infarction (MI)?~   "
166338|NCT01388491|"~     This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive~     compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy~     women.~   "
166339|NCT01388478|"~     By doing this study, researchers will examine the safety and tolerability of R-pramipexole in~     participants with Alzheimer's disease. This study will also examine the body and brain's~     response to the study drug by measuring the amount of injury to the cells (oxidative stress)~     in the blood and spinal fluid and brain imaging before and after treatment.~   "
166340|NCT01388465|"~     The investigators are testing the hypothesis that patients who are exposed to daily~     text-message (TM) assessments with feedback will have better adherence to prescription than~     those patients not exposed to TM-based queries with feedback.~   "
166341|NCT01388452|"~     Purpose: The purpose of this research study is to learn about two HIV tests - a clinical~     presumptive diagnosis (PD) that a trained healthcare provider can quickly use to determine~     if a child is likely to be HIV-infected and in need of HIV medicines and an expedited gold~     standard RNA-PCR test (expedited PCR) that is done at the UNC Project lab located at the~     hospital and the result given within 48 hours. Both of these tests can obtain results quickly~     while the current test called dried blood spot DNA-PCR goes to a lab and the result may take~     up to one month. The performance of PD and expedited PCR will be compared to one another with~     respect to HIV-infected infants correctly initiating life-saving antiretroviral therapy.~      Participants: Hospitalized children younger than 12 months of age who are HIV DNA-PCR~     eligible at Kamuzu Central Hospital (KCH), in Lilongwe, Malawi. Other participants will be~     patient caregivers and clinical officers who provide healthcare for children that could be~     HIV-infected. Clinical officers will be trained to conduct the presumptive diagnosis test.~      Procedures (methods): Patients will be randomized to either standard of care (PD and dried~     blood spot DNA-PCR) or expedited PCR. A consultant pediatrician and a clinical officer will~     perform the PD. If the PD or expedited PCR test results are positive, hospital care could~     include HIV medicine.~   "
166342|NCT01388439|"~     Oseltamivir dosing in infants < 3 months of age is based on a single pharmacokinetic study in~     20 infants from a single center. This dataset is limited by a lack of robustness, because~     only 1 sample was collected from each participant. The investigators obtained two blood~     samples each from infants receiving oseltamivir after obtaining informed consent from the~     infant's parents. The investigators propose to analyze the blood samples to determine the~     amount of oseltamivir in the infant's blood. Measurement of these values will increase the~     understanding of the absorption and elimination of oseltamivir in preterm and term infants,~     and improve our ability to provide the correct doses to this high risk population.~   "
166373|NCT01388036|"~     Beta 1 Adrenergic antagonists (beta blockers) have major role in the treatment of CHF, IHD~     and hypertension. However, there is large interindividual variability in the response to beta~     blockers.~      The hypothesis underlying this study is that genetic differences between individuals will~     determine the individual response to esmolol, a betablocker that is administered~     intravenously. Esmolol will be administered intravenously to healthy volunteers, and the~     effects on heart rate and blood pressure will be monitored. In addition, we will measure~     plasma renin activity and plasma levels of norepinephrine.~   "
166343|NCT01388426|"~     Objective of this study is to evaluate the tolerance and potential benefit of moisture~     chamber glasses for dry eye in an Asian population. In this clinic based prospective~     interventional study, we aim to recruit patients (until 10 patients complete the study) who~     have evaporative dry eye due to exposure to environmental stress (such as frequency of out~     door activities) and keen to try out moisture chamber glasses/ eyewear from the dry eye~     clinic in Singapore National Centre. After informed consent, these patients will be~     prescribed 7eye( Panoptx)™ moisture chamber glasses/eyewear for 3 months and will be~     monitored on a diary for the amount of time wearing eyewear for 2 weeks and the number of eye~     drops for each type of medication used. Other outcomes will be changes in symptoms of dry eye~     using visual analog scale, as well as objective signs of dry eye (eg. corneal fluorescence~     staining and tear break up time (TBUT). As moisture chamber spectacles are currently not~     available as a treatment option for dry eye in Singapore, the findings of this study will~     give an insight to the efficacy of this new treatment modality in our population.~   "
166344|NCT01388413|"~     Symptomatic urinary tract infections (UTIs) are one of the main causes of morbidity and the~     main cause of re-hospitalization in subjects with neurogenic bladder. Long-term antibiotic~     therapy increases the risk of multi-resistant bacterial infections, without reducing the rate~     of symptomatic UTIs. Our non-comparative preliminary study has shown that Weekly Oral Cyclic~     Antibiotic Programme (single, weekly dose of antibiotic X on even weeks, and antibiotic Y on~     odd weeks) seem to drastically reduce both the number of symptomatic UTIs and the number of~     hospitalizations in patients with neurogenic bladder, without affecting bacterial ecology.~      The objective of this study is to validate this preliminary work with a large-scale~     randomized, parallel-group, multicenter study.~   "
166345|NCT01388400|"~     Stroke contributes significantly to the incidence of disabilities, with upper limb (UL) motor~     impairment being especially prevalent. Animal studies suggest that post-stroke motor recovery~     is largely attributable to adaptive plasticity in brain motor areas. While some environmental~     training factors contributing to plastic mechanisms have been identified in animals,~     translation of this knowledge to the clinical setting is insufficient. Optimal recovery may~     be related to both external (e.g., feedback type) and internal factors (e.g., cognitive~     ability, motivation). Clinically feasible methods for training are needed. Use of enriched~     virtual environments (VEs) may provide a way to address these needs. Outcome measures that~     best reflect recovery need to be identified since this is an essential step to evaluate the~     effect of novel training programs for UL motor recovery in stroke.~      The research question is which clinical and kinematic outcome measures best reflect motor~     performance recovery after a targeted upper limb treatment intervention. Aim 1 is to compare~     changes in outcome measures recorded before and after an upper limb intervention in stroke~     subjects to motor performance in healthy subjects. Aim 2 is to determine motor performance~     between-group differences sample size is based on knowledge of expected outcome measure mean~     score differences between groups. Hypothesis. 1: Specific clinical and kinematic outcome~     measures will be sensitive to within-group (pre-post intervention training) changes.~     Hypothesis. 2: Specific clinical and kinematic outcome measures will be sensitive to~     between-group (healthy vs. patients in enriched vs. conventional intervention groups. Sixteen~     chronic stroke survivors and 8 age- and sex-matched healthy controls will participate.~     Patients will be matched on cognitive and motor impairment levels and divided into two~     groups. Using an single subject (A-B-A) research design, kinematics during two pre-tests, 3~     weeks apart, will be recorded for test-retest reliability. Stroke groups will practice varied~     upper limb reaching movements (15 45-minute sessions in 3 weeks) in environments providing~     different motivation/feedback levels. Pre- and post motor performance evaluations will be~     done with clinical tests and a Test Task with specific motor performance requirements. A~     Transfer Task will also be recorded. By comparing data analysis methods (3-Dimensional (3D)~     analysis of different markers or placements), the investigators will identify which kinematic~     outcome measures best reflect motor improvement in post-test and follow-up sessions~     (retention).~      The expected results are identification of two primary and two secondary outcome measures~     that reflect upper limb motor recovery and can distinguish between motor recovery and~     compensation. The results will be used to design a randomized control trial to determine the~     efficacy of VE-based treatment on arm motor recovery. The goal is to determine how extrinsic~     (environmental) and intrinsic (personal) motivational factors affect motor learning in stroke~     survivors with cognitive and physical impairment. Knowledge gained can also be used for~     rehabilitation of other neurological and orthopedic pathologies.~   "
166346|NCT01388387|"~     The choice of an immunosuppressant after hepatic transplant is now more difficult than before~     because of the increasing number of drugs available.~      Pharmacokinetic, pharmacodynamic and pharmacogenetic information can help to choose the best~     treatment and the best dose for each patient. The genetic polymorphism of enzymes~     metabolizing treatments can affect their efficacy and safety. Concerning tacrolimus, CYP3A5~     activity is a major determinant of the dose needed to reach target concentrations. This study~     is aimed at evaluating the impact of both donor and recipient CYP3A5 genetic polymorphisms on~     tacrolimus exposure in patients with hepatic transplant.~   "
166347|NCT01388374|"~     The aim of this study is to explore whether the implementation of Nurse Practitioners can~     lead to a more accessible and efficient patient care at the primary out of hours service.~      The primary objectives of the proposed study are:~        1. What are the effects of the implementation of NPs on the primary out of hours service in~          comparison with the current out of hours service? Effects in terms of accessibility,~          objective and subjective workload of general practitioners, quality of care and patient~          satisfaction.~        2. How efficient is the implementation of NPs in the primary out of hours services?~        3. What is the feasibility of the implementation of NPs in the out of hours services? And~          under which conditions?~        4. What are the barriers and facilitating factors considering the implementation of NPs?~   "
166348|NCT01388361|"~     This trial is conducted in Europe and North America. The aim of this trial is to compare the~     efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest~     meal to insulin degludec in subjects with type 2 diabetes.~      Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643~     (NCT01193309) trial will be randomised to receive treatment intensification while subjects~     with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to~     receive insulin degludec treatment. Subjects are to continue their pre-trial metformin~     treatment.~   "
166349|NCT01388348|"~     Current gold standard of bladder outlet diagnosis is pressure flow study. This study is~     invasive time consuming and requires expensive and complex set-up. In this study the~     investigators plan to evaluate an alternative technology that presumably is able to diagnose~     bladder outlet obstruction using a Dynamic Urine Vibration Holter based on a Urine Flow~     Vibration Analysis technology. The acoustic vibration sensor is a small device that records~     the vibration due to urine flow. The patient attaches the sensor to the penis using a~     disposable sensor patch for the duration of approximately one minute during one urination.~     The analysis is performed off-line and the results are compared to the results of a standard~     pressure flow study. The innovative technology for the diagnosis of bladder outlet~     obstruction is noninvasive, rapid and does not involve complex setup.~   "
166374|NCT01388023|"~     In a previous study the prevention of halitosis by the herbal formula and delivery system~     (SmellX), were established both in vitro and clinicaly. The duration of relief was~     established as long as 8 hours. In this study the investigators intend examine the day long~     efficacy of SmellX.~   "
166350|NCT01388335|"~     The purpose of this study is to assess the effect of enzastaurin (LY317615), on a protein~     (enzyme CYP2C9) which is involved in the metabolic pathway of warfarin in patients with solid~     tumors or lymphomas. Information about any side effects that may occur will also be~     collected. This is a drug interaction study so the treatment of the disease will not be the~     main purpose of the study.~      This is a Phase 1, open label, fixed sequence, 2 period study conducted in patients with~     solid tumors or lymphomas. The duration of participation in this study will be up to~     approximately 38 days not including screening, after which patients will be allowed to~     continue receiving enzastaurin. There is no planned duration for the extension phase of this~     study; patients will be allowed to continue to receive enzastaurin until fulfilling one of~     the criteria for discontinuation, such as unacceptable toxicity or disease progression.~   "
166351|NCT01388322|"~     This is a Multicenter, randomized, open‐label, parallel groups study to test the hypothesis~     that prophylactic low molecular weight heparin (LMWH) (enoxaparin) initiated before 14 weeks~     of gestation could improve maternal and perinatal outcome in women at high risk for~     developing placental‐mediated pregnancy complications.~   "
166352|NCT01388309|"~     This observational study will evaluate in clinical practice the change in Disease Activity~     Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who~     are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from~     eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without~     methotrexate) for 12 months.~   "
166353|NCT01388296|"~     the target of this study is to assess the minimum alveolar concentration of sevoflurane to~     maintain theBispectral Index below 50.The minimum alveolar concentration (MAC) for~     maintaining Bispectral Index below 50 (MACBIS50) of sevoflurane has been reported previously~     in adult with Body Mass Index ( BMI) < 40 to be 0.97 and in enfant to be 2.83%, However,~     there is no study assessed theBispectral Index below 50 (MACBIS50 ) in morbidly obese patient~     (BMI > 40). The first aim of our study is to assess the MACBIS50 of sevoflurane in morbidly~     obese patients BMI 40 - 70 using the Continuous Reassessment Method (CRM) in 80 % of~     patients.~   "
166354|NCT01388283|"~     The purpose of this study is to assess the predictive role of serum inflammatory markers in~     pregnant women who subsequently develop preeclampsia.~   "
166355|NCT01388270|"~     The purpose of this study is to determine whether the heparin-coated dialysis filter is~     superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis~     (HD) patients.~      The antithrombogenic properties of the heparin-coated dialysis filter and of the conventional~     filter will be compared by means of statistical tests.~   "
166356|NCT01388257|"~     The purpose of this study is to demonstrate, in patients treated with adalimumab, the~     efficacy of proctological surgery in anoperineal fistula healing after the removal of seton~     drain.~   "
166357|NCT01388244|"~     The Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE) is a randomised~     population-based study, including 20,904 Danish women aged 65-81 years, investigating the~     effectiveness of a two-step screening programme for osteoporosis, using a questionnaire based~     on FRAX® followed by DXA-scan of those at highest risk. Further, the study is expected to~     provide knowledge about cost-effectiveness, patient preferences and acceptance of screening~     programme to prevent fractures~   "
166358|NCT01388231|"~     The study aims at examining the effects of additional training in manualized~     cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia. The~     investigators will investigate how CBT, specifically the treatment procedures and manuals~     proposed by Clark and Wells (1995), can be transferred from controlled trials into the less~     structured setting of routine clinical care, and whether the health care system benefits from~     such developments. Private practitioners (N=36) will be randomized to one of two treatment~     conditions (i.e., training in manualized CBT vs. treatment as usual without specific~     training). The investigators plan to enroll 160 patients (80 per condition) to be able to~     detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out rate of 25%~     (N=116 completers; N=58 per condition). The study is genuinely designed to promote faster and~     more widespread dissemination of effective interventions. The following research questions~     can be examined: (1) Can manualized CBT be successfully implemented into routine outpatient~     care? (2) Will the new methods lead to an improvement of treatment courses aned outcomes? (3)~     Will treatment effects in routine psychotherapeutic treatments be comparable to those of the~     controlled, strictly manualized treatment of the main study?~   "
166359|NCT01388218|"~     The purpose of the protocol is to develop final draft PRO instruments of physical activity in~     daily life to be used and evaluated in the further validation studies measuring physical~     activity in chronic obstructive pulmonary disease (COPD) patients.~   "
166360|NCT01388205|"~     This study aims to implement a new family-based health behavior community program to increase~     time spent outdoors and physical activity among Singapore children aged 6 to 12 years in a~     1-year randomized clinical trial. 300 children from 250 families will be randomly assigned to~     either a family-based intervention or no intervention. The family-based intervention~     comprises structured weekend outdoor activities organized by National Parks and incentives~     for children to wear a pedometer and increase their daily steps. Families who meet their~     monthly step and outdoor activity goals will receive a range of prizes and incentives. Both~     groups will receive brochures on the National Myopia Prevention Program and physical~     activity. The success of the intervention will be evaluated through light meters, 7-day~     outdoor diaries, questionnaires documenting outdoor time and myopia; as well as pedometer~     steps, walking tests, and body mass index. A community-based intervention will be developed~     to improve the health of Singapore children by increasing outdoor time and physical activity~     to prevent myopia and obesity.~   "
166375|NCT01388010|"~     The purpose of this study is to evaluate the effect of a commercially available fermented~     dairy product containing probiotics (4 weeks, twice a day) on the improvement of~     gastrointestinal well being and digestive symptoms in adult women reporting minor digestive~     troubles among the general population.~   "
166389|NCT01387828|"~     The purpose of this study is compare two different surgical treatments of splenic artery~     aneurysms: open and laparoscopic approach.~   "
166390|NCT01387815|"~     The current study will compare the real - life effectiveness of adalimumab to topical and~     traditional systemic agents in the management of psoriasis and its impact on the patient's~     quality of life and societal burden of illness.~   "
166361|NCT01388192|"~     Pancreaticoduodenectomy (PD) involves removing the head of pancreas, duodenum, common bile~     duct, gall bladder, and/or distal stomach. In general, the postoperative changes are thought~     to be moderately severe, and about 20% of these patients go on to develop new clinical~     diabetes. PD-related factors of glucose metabolism will include removal of half of the~     pancreatic endocrine tissue, exclusion of the proximal small intestine, postoperative weight~     loss (on average, ~8% of body weight), and removal of putative diabetogenic factor in~     resected neoplasm. However, effect of removal of duodenum on glucose metabolism after PD has~     never been studied. The investigators plan to examine this issue by comparing fasting plasma~     levels of insulin, fasting plasma glucose, C-peptide, HbA1C, HOMA-insulin resistance, GLP-1~     response after a standard meal, and body mass index (BMI) of patients before and after PD.~   "
166362|NCT01388179|"~     Autism is a developmental disorder characterized by abnormalities in speech and~     communication, impaired social functioning, and repetitive behaviors and interests. The term~     Autism spectrum disorders or ASD is often used to include autistic disorder, Asperger~     syndrome and pervasive developmental disorder-not otherwise specified (PDD-NOS).~     Epidemiological research suggests that ASDs affect at least 60 per 10,000 youth, with~     estimates as high as 120 per 10,000.~      Severity of autistic features is not easily defined and the use of different diagnostic tools~     compounds the ability to lay a clear cut definition. It is, though, generally accepted that~     children with autism and normal IQ (>70) are high functioning regardless of the severity of~     their autistic features. The investigators will use the terms autism and ASD~     interchangeably, and the term low functioning autism will be used to describe those~     children with autism who have, or are presumed to have, IQ<70.~      The pathophysiology of autism has been studied extensively in the last decade. Abnormal~     neuronal connectivity has been implicated in a growing body of research. In addition, areas~     of over and/or under neuronal activation have been detected on functional MRI(Magnetic~     Resonance Imaging).~      Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive technique that allows to~     affect brain activity. The pulses are administered by passing high currents through an~     electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric~     field in the underlying brain tissue. When the induced field is above a certain threshold,~     and is directed in an appropriate orientation relative to the brain's neuronal pathways,~     localized axonal depolarizations are produced, thus activating the neurons in the relevant~     brain structure.~      rTMS has been studied in individuals with high functioning autism. rTMS treatment was found~     to have an electrophysiological effect and to reduce repetitive behaviors and improved social~     functioning.~      In the context of existing pilot data suggesting effect of rTMS treatment in individuals with~     high functioning autism, the investigators propose a pilot study to assess the efficacy of~     rTMS in children and adolescents with low functioning autism.~   "
166363|NCT01388166|"~     The objective of this observational study is to collect and evaluate data on medication~     adherence of patients on maintenance COPD therapy with long-acting anticholinergic (e.g.~     Spiriva® delivered by HandiHaler® or Respimat®) using the MMAS-8 questionnaire.~   "
166364|NCT01388153|"~     To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken~     without or with water and the Glucobay standard tablet taken with water~   "
166365|NCT01388140|"~     The goal of the project is to investigate the prevalence of dissociative disorders in~     psychiatric inpatients in Taiwan. Relevant clinical issues, including common psychiatric~     comorbidity (e.g., positive psychotic symptoms), associated psychosocial factors (e.g.,~     negative life events, perceived parenting style), and neuro-cognitive underpinning (e.g.,~     executive functions) were also targeted. Standardized interview schedules, self-report~     scales, and cognitive tasks will be applied. The investigators hypothesized that dissociative~     disorders would be associated with positive psychotic symptoms, a history of early~     interpersonal adversity, and enhanced executive functions.~   "
166366|NCT01388127|"~     The investigators will perform a double blind controlled study to investigate the efficacy of~     oral administration of 200 mg minocycline, on the neurological and functional outcome after~     acute hemorrhagic stroke and the effect on blood brain barrier permeability.~   "
166367|NCT01388114|"~     The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor~     for serum PCT level measurement will offer a test with lower cost, and increase the~     applicability of serum Procalcitonin (PCT) level in daily clinical practice.~   "
166368|NCT01388101|"~     To develop a real-time diagnostic technique with e- Ab sensor for specific LECT2 detection in~     clinical specimens of Hepatocellular carcinoma (HCC) patients, the investigators conduct a~     prospective clinical study. In comparison with results from direct sequencing of LECT2, the~     investigators evaluate the performance of e- Ab sensor, including reproducibility,~     sensitivity, specificity, and cross-reaction. With such technique, the investigators can~     obtain LECT2 information of HCC patients in cost-saving and time-saving way and can offer~     more individualized treatment for our patients.~   "
166369|NCT01388088|"~     The investigators wish to investigate the potential effects of potassium. In this study we~     will examine patients with hypertension and increase their potassium-levels using Amiloride~     and Spironolactone.~      The investigators will examine the changes in the cardiovascular system using a~     Sphygmocor-scanner.~   "
166370|NCT01388075|"~     The genetic factors associated with variability in CYP2C9 induction have not been elucidated.~     The hypothesis underlying this study is that following 7 days treatment with rifampicin, a~     known CYP450 inducer, the genetic variability in regulatory elements controlling CYP2C9~     expression will be associated with the magnitude of change in INR response to warfarin and in~     CYP2C9-mediated warfarin metabolism.~   "
166371|NCT01388062|"~     The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor~     for influenza virus detection, the investigators conduct a prospective clinical study. In~     comparison with results from direct sequencing of influenza virus, the investigators evaluate~     the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and~     cross-reaction. The potential factors which may interfere with the results would be~     investigated. With such technique, the investigators hope to make early diagnosis and give~     influenza virus patients early treatment to reduce the complications and case-fatality rate.~   "
166372|NCT01388049|"~     To develop a real-time diagnostic technique with e- Ab sensor for Entervirus 71 detection,~     the investigators conduct a prospective clinical study. In comparison with results from~     direct sequencing of Entervirus 71, the investigators evaluate the performance of e- Ab~     sensor, including reproducibility, sensitivity, specificity, and cross-reaction. The~     potential factors which may interfere with the results would be investigated. With such~     technique, the investigators hope to make early diagnosis and give EV71 patients early~     treatment to reduce the complications and case-fatality rate.~   "
166391|NCT01387802|"~     The current study will assess the real - life effectiveness of adalimumab in the management~     of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of~     extra-articular manifestations.~   "
166376|NCT01387997|"~     To develop a real-time diagnostic technique with e- Ab sensor for high risk human papilloma~     viruses(high risk HPV) detection, the investigators conduct a prospective clinical study. In~     comparison with results from direct sequencing of HPV, the investigators evaluate the~     performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and~     cross-reaction (such as detection of low risk HPV). The potential factors which may interfere~     with the results would be investigated. With such a real-time diagnostic technique, the~     investigators hope to obtain information of patients in cost-saving and time-saving way and~     can give patients early treatment and offer more individualized treatment for our patients.~   "
166377|NCT01387984|"~     In this study, the investigators plan to establish the relationship between plasma~     concentration of YKL-40 with various vascular complications in the patients of type 2~     diabetes.~   "
166378|NCT01387971|"~     Currently, due to the advantage of noninvasive, localized, rapid, painless and easily~     repeatable of impression specimens, the technique is an ideal method of investigating ocular~     surface disorders when the diagnosis is not clinically obvious or detecting the~     post-operative change without tissue damage. Using impression cytology for primary diagnosis~     and follow-up of ocular surface squamous neoplasia, including after therapy with topical~     mitomycin C has been well-studied. [29]. In addition to the applications described above,~     pterygium is another disease of interest. Pterygium, a common disease of ocular surface, has~     high recurrence rate after surgical excision. [30-33] However, the exact etiology and~     mechanism for recurrence is unknown. A transformation of the phenotypic characteristics of~     the conjunctival fibroblasts may play an important role. Due to the concern of improvement in~     treatment, it is important to explore the change of cytomorphology after pterygium operation,~     to identify the risk factors of developing recurrence, and, furthermore, to clarify the~     etiology and mechanism. Some ophthalmologists may think this procedure too time-consuming to~     be a routine examination in outpatient clinics. [34] However, National Taiwan University~     Hospital (NTUH), as one of the largest tertiary medical centers in Taiwan, is now in charge~     of a big part of difficult cases of ocular surface. With the need of further precise~     diagnosis and delicate clinical skills, the investigators are competent for this meaningful~     program.~   "
166379|NCT01387958|"~     This is a proof of concept study, designed to look at the safety and antiviral activity of~     LCQ908 in hepatitis C infected patients.~   "
166380|NCT01387945|"~     This intervention study will evaluate the feasibility,acceptability and effectiveness of an~     e-health enabled model of care by randomly assigning a trained patient navigator and/or a~     blood pressure (BP) self-management web portal to patients with uncontrolled hypertension~     after a run in period with a home BP monitor (HBPM) and comparing the results on blood~     pressure control. We anticipate that patients receiving the combination of a patient~     navigator(PN)with a self-management web portal and home BP monitor will have better BP~     control than when the only received a home BP monitor.~   "
166381|NCT01387932|"~     The purpose of this study is to evaluate overall survival in patients treated with~     HepaSphere/QuadraSphere compared to conventional transarterial chemoembolization with~     particle PVA.~   "
166382|NCT01387919|"~     Several studies have begun to determine the time course of events sensing energy availability~     in rodents. In contrast, there is not a single study that has examined this in humans to~     date. A better understanding of this energy sensing machinery in humans is of utmost~     importance to give us new insights into developing new therapies for common diseases such as~     obesity, diabetes mellitus, cardiovascular diseases and cancer. In these diseases,~     disturbances in the energy-sensing machinery possibly play a role. To determine the time~     course of energy sensing events in humans, the investigators will measure the concentration~     of various hormones in plasma, and biochemical changes in skeletal muscle at sequential time~     points during starvation in humans. The investigators choose to study the molecular machinery~     in muscle, since muscle is very sensitive to fuel deprivation.~   "
166383|NCT01387906|"~     The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost~     .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is~     a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the~     Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will~     be day 270 period.~   "
166384|NCT01387893|"~     The objective of this study was to evaluate the effectiveness of the Digital Repetitive~     Infrapubic Pressure maneuver, a self-administered procedure used to provide symptomatic~     relief in initiating and maintaining urine flow impeded by benign prostatic hyperplasia.~   "
166385|NCT01387880|"~     This is an open, multicenter phase II trial of therapy with a combination of cetuximab, and~     irinotecan every second week combined with a daily dose of everolimus to patients with~     metastatic colorectal cancer with Kirsten rat sarcoma viral oncogene (KRAS) mutation or to~     patients resistent to cetuximab and irinotecan therapy for metastatic colorectal cancer.~   "
166386|NCT01387867|"~     According to Danish and international guidelines the recommended first-line of management for~     people with osteoarthritis consist of exercise, education, analgesic medication, and, if~     necessary, weight reduction. It is well documented that exercise has a positive effect on~     pain and physical function in patients with knee OA, but the effect of exercise on hip OA is~     sparsely investigated.~      Aim of the study: To investigate the effects of 1) strength training, and 2) Nordic Walking,~     and 3) unsupervised home based exercise on muscle function, endurance, pain level, physical~     activity, and health related quality of life in patients with osteoarthritis of the hip.~      The effects of exercise on muscle mass and the mechanisms behind the osteoarthritis, i.e.,~     disease activity, inflammation, and cartilage degradation, are investigated in a subgroup~     (n=45) of the participants.~      Study hypotheses: Strength training will have a greater effect on physical function and~     muscle strength than Nordic Walking and home based exercise; 2) Nordic Walking will have a~     greater effect on endurance than strength training and unsupervised home based exercise; 3)~     Strength training and Nordic Walking will have a greater effect on pain level and health~     related quality of life than unsupervised home based exercise.~   "
166387|NCT01387854|"~     There is limited information on the long-term effects of treating patients with MPS VI with~     Naglazyme® and limited data on the natural history of treated and untreated MPS VI patients.~     The Re-survey Study ASB-00-03 will assist in understanding the effects of long-term Naglazyme~     treatment and the natural history of the MPS VI patient population.~   "
166393|NCT01387776|"~     This is a study for the evaluation of the benefits of 1 st Trimester risk markers in~     detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a~     potential marker for Trisomy 21 and other aneuploidies.~      Aim of this prospective nonprofit study is to analyze the benefits of early onset pre~     eclampsia risk assessment in the 1st trimester (measuring biochemical markers [PIGF], blood~     pressure and Doppler ultrasound), and how the results can permit to modify or influence the~     course of the preeclampsia during the pregnancy. The investigators will also evaluate the~     potential use of the PIGF as a marker to improve the prenatal screening with the currently~     used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta~     subunit of human chorionic gonadotropin (fBhCG) parameters.~   "
166394|NCT01387763|"~     The purpose of the study is to compare the efficacy and toxicity including quality of life of~     two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea~     (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant~     interferon.~   "
166395|NCT01387750|"~     A single center trial to evaluate the efficacy, tolerance, and acceptability of Oxygenated~     Glycerol Triesters (OGT) mentholated cream on acute musculoskeletal pain in normal healthy~     adult volunteers suffering from a recent inflammation of muscles and joints. Patient who met~     eligibility requirements were instructed to identify one area on their body where they were~     experiencing the most acute musculoskeletal pain/discomfort. Patients were provided with~     visual analog scales in order to quantify their pain. Patients either received mentholated~     cream with or without OGT and instructed to rub on the identified site 3 times a day for 7~     days. Pain and other observations were written in a diary for each day.~   "
166396|NCT01387737|"~     The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or~     combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type~     2 diabetes mellitus on 52 weeks oral administration.~   "
166397|NCT01387724|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients~     with newly diagnosed neuroblastoma.~   "
166398|NCT01387711|"~     This trial will be conducted to explore the biological effects in the skin following~     treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by~     histology.~   "
166399|NCT01387698|"~     The primary objective of this study is to confirm the long-term efficacy (remission and~     maintenance in remission) of current validated treatments. Each patient will be followed~     during 3 years in this non-interventional trial.~   "
166400|NCT01387685|"~     Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The~     investigators will compare data from the chart, telephone interviews and physical~     examinations between those who underwent mesh placement to those who underwent placement of~     PIVS.~   "
166401|NCT01387672|"~     Purpose: NABT: To compare five widely available nitrate formulations: (1) 15 of nitroglycerin~     (NTG) ointment, (2) 0.3 mg and (3) 0.6 mg of sublingual NTG, (4) 20 mg of isosorbide~     mononitrate (an oral tablet), and (5) 160 mg of glycerol trinitrate (a patch), for their~     efficacy on markers of bone formation and resorption and for the incidence and severity of~     headache they cause.~      Hypothesis: There is one ideal nitrate preparation which balances the clinical efficacy in~     bone remodeling against the common side effect of headache.~      NABT-B: To determine if nitrates affect markers of bone formation (serum BALP and P1NP) and~     resorption (serum CTX and urine NTX) in women who have recently discontinued treatment with~     alendronate, risedronate or zoledronate.~   "
166402|NCT01387659|"~     This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in~     diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant~     recipient population, our study will determine any different responses, including~     autoimmunity, between Hispanic, and Caucasian, patients.~   "
166403|NCT01387646|"~     The purpose of this Stage II clinical trial is to test the efficacy of a culturally~     sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority~     adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy~     and abuse by changing high-risk sexual behaviors, decreasing substance use and encouraging~     contraceptive use. Its primary goal is to expand risk-reduction interventions created in~     previous studies to further increase intervention efficacy for this particularly vulnerable,~     high-risk group. An adolescent intervention has been created and pilot tested in~     developmental studies. Results indicated reductions in substance use, risk behaviors,~     unintended pregnancy, STI and abuse without reports of adverse outcomes. Specific aims of the~     current study include: 1) To obtain a more in-depth understanding of configurations of~     psychosocial and situational factors associated with high-risk sexual behavior, substance~     use, STI/HIV and contraceptive use among abused minority adolescent women with STI; 2) To~     implement a controlled randomized trial of a cognitive behavioral risk-reduction intervention~     consisting of 2 small group sessions, 2 individual counseling and 3 support groups for this~     group; 3) To evaluate the effects of the adolescent intervention model versus enhanced~     counseling for this group on AIDS Risk Reduction Model (ARRM)-related constructs, high-risk~     sexual behavior, substance use, abuse recurrence, contraceptive use, unintended pregnancy and~     STI/HIV at 6 and 12 months follow-up. Participants will include a convenience sample of 600~     Mexican-and African American adolescent women, aged 14-18 years with a history of sexual or~     physical abuse and current STI.~   "
166404|NCT01387633|"~     The purpose of this study is to evaluate the impact of an educational program for people with~     diabetes mellitus based on the family social support.~   "
166405|NCT01387620|"~     This prospective study was performed to compare two ophthalmic viscosurgical devices,~     DisCoVisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose~     2% in terms of their overall clinical performance during phacoemulsification.~   "
166406|NCT01387607|"~     The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared~     with placebo for management of fibromyalgia in adults.~   "
166407|NCT01387594|"~     Study is designed to show a lack of effect on white blood cells circulating in the spinal~     fluid.~   "
196807|NCT00987298|"~     The goal of this project is to compare visceral fat measurements derived from Lunar iDXA~     total body scans and from Computed Tomography (CT) scans of the abdominal region.~   "
166408|NCT01387581|"~     The objective of this study is to determine and compare the performance of dermatologists (in~     Germany) on the excision decision against the performance of MelaFind, a non-invasive and~     objective multi-spectral computer vision system designed as a tool to aid dermatologists in~     the detection of early melanoma. The hypothesis is that MelaFind's sensitivity is superior to~     the average excisions sensitivity of dermatologists.~      Another objective is to determine and compare the performance of dermatologists (in Germany)~     with and without the aid of MelaFind. The hypothesis is that the average excision sensitivity~     of dermatologists with the aid of MelaFind is superior to the average excision sensitivity of~     dermatologists without the aid of MelaFind.~      A similar study was previously conducted with dermatologists in the US (NCT01011153). An~     exploratory objective is to compare the excision decisions of dermatologists from the~     previous study (in the US) to dermatologists in in this study (in Germany).~   "
166409|NCT01387568|"~     In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine~     in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and~     hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten~     return of bowel function.~   "
166410|NCT01387555|"~     This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more~     effective in improving survival than best supportive care in patients with advanced~     Hepatocellular Carcinoma (HCC) who have failed sorafenib.~   "
166411|NCT01387542|"~     The purpose of this study is to evaluate the effectiveness and safety of paliperidone~     extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of~     emotional instability, detachment from reality, often with delusions and hallucinations, and~     withdrawal into the self) participants.~   "
166412|NCT01387529|"~     The objective of this study is to establish reference values for non-invasive hydration~     status markers. Although there are no hypotheses associated with this study, the outcome will~     help advance the development of non-invasive hydration status monitors (described above and~     in H08-12; A-15208) capable of detecting dehydration from a single, static measure. The~     outcome that this research effort supports what is recognized by the military community as a~     high priority medical technology gap (MOM ICD v1.3, 2008).~   "
166413|NCT01387516|"~     The long-term objective of this research is to increase the investigators understanding of~     effective smoking interventions for understudied adolescents at high risk for continued~     smoking into adulthood.~      This randomized clinical trial uses a 2 x 2 between groups design to investigate Motivational~     Interviewing (MI) versus Relaxation Therapy (RT), and Cognitive Behavior Therapy (CBT) versus~     Self-Help Programming (SHP). Treatments are provided during brief stay in detention and~     adolescents are followed after release. The investigators seek to increase quit rates~     post-release, and the investigators will examine the moderating and mediating effects of~     motivation, anger, and self-efficacy. The investigators will study main effects for treatment~     as well as whether the combination of MI/CBT is more effective than other treatments in~     enhancing quit rates.~      Frequently, treatment for smoking cessation is unavailable to youths in the juvenile justice~     system, and when treatment is available, it may be provided using untested therapies. This~     study extends previous research by rigorously evaluating smoking cessation interventions~     specifically for teens at highest risk for continued smoking in adulthood. The investigators~     will examine processes contributing to the efficacy of treatments. The development of~     effective smoking interventions for juvenile detainees has the potential to reduce a~     significant public health concern in this undeserved and high-risk population.~   "
166414|NCT01387503|"~     This clinical trial is aimed at extending the chance of liver transplantation, through~     downstaging procedures, to patients with hepatocellular carcinoma (HCC) exceeding~     conventional Milan Criteria.~      Those patients that will achieve a sustained tumor response after downstaging will be~     randomized either to undergo liver transplantation or to proceed with conventional~     non-transplant treatments.~      The aim of the study is to demonstrate unequivocally that liver transplantation may provide a~     survival benefit, with an acceptable survival rate of at least 60% at 5 years, to patients~     that demonstrate a radiological and sustained tumor response after downstaging. Noteworthy is~     that response is chosen rather than stage migration as endpoint of downstaging.~   "
166415|NCT01387490|"~     This study compares the effects of Individualized Scheduled Telephone Support (ISTS) and~     Usual Care (UC) for service members with Mild Traumatic Brain Injury (mTBI). A total of 400~     service members will participate in this study. ISTS is a telephone intervention that~     provides injury-related education, training in problem solving, and focused behavioral~     strategies for problems (e.g. anxiety, depression) that commonly co-occur with MTBI. ISTS~     also includes access to usual care and web-based and printed educational material. The 12~     phone calls included in ISTS will be administered over a 6-month period. UC is the usual care~     provided to service members attending the Traumatic Brain Injury (TBI) Clinics at Madigan~     Army Medical Center and Womack Army Medical Center, plus web-based education and 12 mailings~     of educational materials over a 6-month period. Subjects will complete major assessments at~     study entry and then 6 months and 12 months later. The primary aim of the study is to compare~     the effects of ISTS and UC on post-concussive symptoms and emotional distress at the 6-month~     assessment. The investigators predict that participants who receive ISTS will report lower~     levels of post-concussive symptoms and emotional distress at the 6-month assessment.~     Secondary aims include comparing the longer term effects of ISTS and UC at the 12-month~     assessment, as well as comparing their effects on other outcomes such as post-traumatic~     stress symptoms, quality of life, resilience, and work activity.~   "
166432|NCT01387256|"~     This double blinded, placebo-controlled randomized trial will compare the safety, efficacy~     and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period~     (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of~     mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800~     mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the~     participant.~   "
166433|NCT01387243|"~     To assess the feasibility and acceptability of genuine pharmacy follow up of people wishing~     to lose weight.~   "
166434|NCT01387230|"~     The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation~     Powder is safe and effective compared with placebo or no active drug intake, when~     administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).~   "
166416|NCT01387477|"~     Tight glucose control in intensive care has become a major concern, allowing a reduction in~     morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which~     can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG~     and measures of brain electrical activity noninvasively. It has already been shown that its~     value changes according to hypoglycemia and its correction. Furthermore, if the hormonal~     response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case~     in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of~     glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a~     substrate for gluconeogenesis and an energy substrate during critical situations. It has been~     shown to improve neurological tests during hypoglycaemia and had cerebral protective~     properties after a severe head injury. The hypothesis of this study is that sodium lactate is~     superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic~     variation, brain function and hormonal response.~   "
166417|NCT01387464|"~     The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium~     in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to~     routine cataract surgery.~   "
166418|NCT01387451|"~     Retrospective studies have combined positron-emission tomography and computed tomography~     (PET-CT) to identify adipose tissue with a high rate of uptake of~     18F-fluorodeoxyglucose(18F-FDG) as active brown adipose tissue(BAT). In addition, biopsy~     specimens and immunohistochemical staining with a UCP1-specific antiserum were used to~     indicate that normal adults were able to have BAT. However,these studies only chose few~     subjects and limited to the neck tissue. Therefore, the investigators intend to test BAT in~     different parts of adults and analyse the clinical factors.~   "
166419|NCT01387438|"~     Previous studies have shown that active brown adipose tissue (BAT) is present in adults and~     may play important roles in material and energy metabolism. However, most of these studies~     were tumor-based populations and retrospective study. Due to the large amount in our cohort,~     the investigators are able to promote a cross-sectional study of the incidence and factors of~     BAT in adult chinese. In addition, the investigators can analyse the metabolic profiles in~     healthy adults with active BAT.~   "
166420|NCT01387425|"~     Objectives~      This protocol is intended to provide information regarding the efficacy and safety of the~     nicotine partial agonist varenicline tartrate, at a dose of 1 mg twice daily, for smoking~     cessation in diabetic subjects who smoke. Given that a better understanding of predictors of~     smoking cessation can be useful in identifying potential quitters and likely relapsers and~     that little is known about these predictors in diabetics, the role of different predictors of~     abstinence at the end of the study will also be examined Study Population The study will~     enroll 150 type 2 diabetic patients (≤ 75 years) who are regular smokers (≥10 cigs/day) and~     motivated to stop smoking in each of 2 treatment arms (active drug and placebo) Study Design~     The study is a double-blind, placebo-controlled, randomized clinical trial designed to assess~     the efficacy and safety of varenicline 1 mg BID in comparison to placebo for smoking~     cessation. The duration of active treatment will be 12 weeks and subjects will be followed in~     the nontreatment phase for an additional 12 weeks. This clinical study has an optional~     research component to prolong the follow up in the nontreatment phase for a full year.~     Predictors of abstinence at the end of the study will also be examined Study Endpoints~     Primary Endpoint: Success rates at week 24 in the varenicline vs placebo group. Success rates~     will be defined as the Continuous Quit Rate since last visit. Subjects will be classified as~     responders if they are able to maintain abstinence from cigarette smoking during this period~     of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained~     through reports of cigarette use by means of the Nicotine Use Inventory confirmed by a~     measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on~     the study visit at week 24 Co-primary endpoint: Success rates at week 12 in the varenicline~     vs placebo group. Success rates will be defined as Continuous Quit Rate for Weeks 8 to 12 of~     treatment. Subjects will be classified as responders if they are able to maintain complete~     abstinence from cigarette smoking in each of the last four study visits (week 9, week 10,~     week 11, and week 12) with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will~     be obtained through reports of cigarette use by means of the Nicotine Use Inventory during~     the last four study visits (week 9, week 10, week 11, and week 12) confirmed by a measurement~     of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study~     visit Secondary Endpoint: Success rates at week 52 in the varenicline vs placebo group.~     Success rates will be defined as the Continuous Quit Rate throughout the last three visits~     (week 24, week 36, and week 44). Subjects will be classified as responders if they are able~     to maintain abstinence from cigarette smoking during this period of time with end-expiratory~     exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette~     use by means of the Nicotine Use Inventory during the last three study visits (week 24, week~     36 and week 44) confirmed by a measurement of an end-expiratory exhaled carbon monoxide~     concentration that is ≤ 10 ppm on each study visit Additional Measures: Given that a better~     understanding of predictors of smoking cessation can be useful in identifying potential~     quitters and likely relapsers and that little is known about these predictors in diabetics,~     the role of different predictors of abstinence at week 24 and at week 52 will also be~     examined~   "
166421|NCT01387412|"~     The primary objective of this study is to determine the role of genital warts (GW) on Human~     Immunodeficiency Virus (HIV) acquisition among men who have sex with men (MSM) in Peru. The~     secondary objectives are to determine Human Papillomavirus (HPV) prevalence in HIV positive~     MSM in Peru, risk factors associated with GW, and the knowledge of HPV and HIV among MSM.~   "
166422|NCT01387399|"~     The purpose of this phase I study is to determine the safety, feasibility, maximum tolerated~     dose (MTD), pharmacokinetics and pharmacodynamics of Cisplatin administered as Intraoperative~     Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients with Platinum-Sensitive~     Recurrent Ovarian Cancer.~   "
166423|NCT01387373|"~     This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second~     week in combination with systemic capecitabine and in patients with a HER2-positive tumour in~     combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases~     from breast cancer.~      Only patients without extrahepatic disease are included.~   "
166424|NCT01387360|"~     This clinical study has been planned to determine the effectiveness of a special laser~     treatment intended to correct both near and distance vision in patients who have undergone~     previous cataract surgery.~   "
166425|NCT01387347|"~     Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide~     that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal,~     ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that~     Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259~     (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product~     that meets a major unmet medical need in patients with dry eye.~   "
166426|NCT01387334|"~     Resistance exercise is effective in improving glycemic control in diabetes patients. The~     effectiveness of a home-based resistance exercise program has not been establish.~   "
166427|NCT01387321|"~     In this study, BYL719 will be administered to adult patients with advanced solid tumors whose~     disease has progressed despite standard therapy or for whom no standard therapy exists. The~     trial will investigate the safety and tolerability and determine the MTD of BYL719 in~     Japanese patients.~   "
166428|NCT01387308|"~     Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.~   "
166429|NCT01387295|"~     This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second~     week in combination with systemic capecitabine and in patients with a HER2-positive tumour in~     combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases~     from breast cancer.~      Only patients with limited extrahepatic disease are included.~   "
166430|NCT01387282|"~     The administration of Anamorelin in patients with Stage III-IV non-small cell lung~     cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and~     muscle strength.~   "
166435|NCT01387217|"~     This protocol describes the first administration of GSK2018682 to humans. The study will~     evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending~     doses of GSK2018682. The study will also provide preliminary evidence of the potential~     therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte~     counts.~   "
166436|NCT01387204|"~     GSK1120212 is a reversible and highly selective allosteric inhibitor of MEK1 and MEK2~     activation and kinase activity currently being developed for the treatment of malignant~     melanoma. This is a Phase I, open-label, non-randomized, single-dose study designed to~     characterize the absorption, distribution, metabolism, and elimination (ADME) of a single~     oral dose of MEK inhibitor [14C]GSK1120212 as a solution in male subjects with solid tumor~     malignancies. A sufficient number of subjects will be enrolled to complete approximately four~     evaluable subjects. Following completion of the study, subjects may elect to continue dosing~     with GSK1120212 in the rollover study, MEK114375.~   "
166437|NCT01387191|"~     The objective of this study is to evaluate the incidence of adverse events in Japanese~     pulmonary arterial hypertension subjects treated with epoprostenol injection based on~     prescribing information under the conditions of general clinical practice and also to grasp~     the following items;~        1. Unknown adverse reactions (especially, significant adverse reactions)~        2. Adverse reaction onset status under practical drug use conditions~        3. Factors possibly influential on safety~        4. Factors possibly influential on efficacy~        5. Patient's prognosis, efficacy and safety in long-term use~   "
166438|NCT01387178|"~     Chronic obstructive pulmonary disease (COPD) is characterized by chronic airflow limitation~     caused by inflammation-mediated damage to lung tissue. Although damage to lung tissue in COPD~     appears to be irreversible, evidence suggests that the course of COPD can be altered through~     measures such as smoking cessation, pulmonary rehabilitation, and the use of pharmacotherapy~     for bronchodilation. A primary goal of maintenance pharmacotherapy is to reduce the incidence~     of acute exacerbations and the associated hospitalizations and emergency department (ED)~     visits. Bronchodilation in COPD maintenance therapy can be accomplished with the long-acting~     anticholinergic tiotropium (TIO), long acting beta-agonists (e.g. formoterol, salmeterol),~     methylxanthines (e.g. theophylline), or combination therapy with a long-acting beta-agonist~     and an inhaled corticosteroid (e.g. fluticasone propionate/salmeterol [FSC]).~      The objective of this study is to compare the benefits of combination long-acting~     beta-agonist/inhaled corticosteroid therapy to long-acting anticholinergic therapy. The study~     compares the risk of COPD exacerbations and COPD-related healthcare utilization and costs for~     commercially-insured patients age 40 and older who were prescribed FSC to those prescribed~     TIO. The null hypothesis is that no difference exists between the costs and outcomes of COPD~     patients treated with TIO and those treated with FSC. The test hypothesis is that patients~     treated with either TIO or FSC will incur lower costs and use fewer healthcare resources for~     the management of COPD.~      The source of data for this study was the Ingenix Impact database (formerly the Integrated~     Healthcare Information Services [IHCIS] database). This is an administrative claims database~     that includes patient-level data on enrollment, facility, professional, and pharmacy services~     from approximately 50 million patients covered by more than 40 managed care health plans~     across the United States (US).~      The study design is a retrospective cohort study.~   "
166439|NCT01387165|"~     The DEAL (Diabetes En America Latina) study was a multicenter, cross-sectional,~     epidemiological, questionnaire based study carried out between October 2004 and October 2005~     in 9 Latin American countries.~   "
166440|NCT01387152|"~     Nuclear stress testing evaluates whether the heart receives enough blood, by injection of a~     nuclear isotope during a stress on the heart that permits taking pictures of the heart~     muscle. A low-radiation-dose protocol for nuclear stress testing involves injecting less of~     the nuclear isotope than standard protocols, by utilizing a new, more efficient camera~     (called an Alcyone camera) which could decrease radiation dose to patients while still~     providing excellent clinical information. Subjects will undergo imaging under the Alcyone~     camera after undergoing stress testing with exercise or a standard medication simulating~     exercise, and then at rest if needed. Subjects will have follow-up to measure events~     occurring after the test, such as death, heart attack, unstable angina, repeat emergency~     department visit for chest pain evaluation, or repeat imaging needed to evaluation for~     coronary artery disease. Radiation doses and quality of the images from the imaging with the~     new protocol will be recorded to compare to those used in standard nuclear imaging protocols.~     The primary study hypothesis is that greater than 90% of patients who have a normal very low~     dose stress first myocardial perfusion scintigraphy (MPS) will be free at 3 months after~     study of death, nonfatal myocardial infarction, unstable angina, and repeat emergency~     department visit for chest pain evaluation or repeat anatomical or functional cardiac~     imaging.~   "
166441|NCT01387139|"~     The purpose of this study is to compare the effectiveness of the co-administration of~     intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural~     sedation in the pediatric emergency department. The investigators hypothesize that patients~     receiving co-administration of ketamine and propofol will have a lower rate of adverse~     events, compared to patients receiving ketamine for procedural sedation.~   "
166442|NCT01387126|"~     The aim of this study is to investigate whether the supplementation of a medically supervised~     weight management program with a novel fibre supplement, improves body weight, body~     composition, and laboratory measurements in overweight and obese individuals. All subjects~     will participate in the medical weight management program however the intervention group will~     have 5 grams of a novel fibre supplemented to each meal while the control group will not.~   "
166443|NCT01387113|"~     This is an open label single center phase II trial, evaluating the utility of 64 slice CT~     perfusion (CTP) in acute ischemic stroke (AIS) patients. The main aim is to determine which~     aspects of CTP imaging can aid in expanding the time window for thrombolysis with IV (rt-PA)~     in AIS patients up to 6 hours after symptom onset.~   "
166444|NCT01387100|"~     The purpose of this study is to explore the effects of a brief vocational rehabilitation~     intervention on individuals with arthritis who are concerned about their ability to remain~     employed.~   "
166445|NCT01387087|"~     The objective of the study is to explore safety and tolerability of single ascending doses of~     ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and~     pharmacodynamics in healthy volunteers.~   "
166446|NCT01387074|"~     This is a prospective, non-interventional, observational study to collect data on the use of~     botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.~   "
166447|NCT01387061|"~     Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains~     controversial. The aim of this study was to investigate the outcome of a consecutive cohort~     of patients resected for multiple HCC, without macrovascular invasion, in order to identify~     clinically reliable parameters to select patients for surgery.~   "
166448|NCT01387048|"~     The purpose of this study is to assess the effect of Skinoren® 15% gel compared to no therapy~     on the maintenance of clinical therapy success in subjects with mild to moderate acne~     vulgaris previously treated for 3 months by a monotherapy of this substance and to assess the~     effect of Skinoren® 15% gel, compared to Differin® 0.1% gel on the efficacy and safety during~     a 9-month long-term treatment period.~   "
166449|NCT01387035|"~     The purposes of this study are (I), to evaluate various screening methods for their ability~     to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to~     evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.~   "
166450|NCT01387022|"~     The HIV/AIDS pandemic remains among the investigators greatest public health challenges. In~     the absence of an effective vaccine, focus has shifted to other prevention strategies such as~     pre-exposure prophylaxis. Tenofovir, with potent activity against retroviruses [1], was~     developed for oral use as Viread®, which is widely used for HIV treatment. The efficacy of~     Viread® has been demonstrated in treatment-experienced and naïve patients [2,3]. In~     antiretroviral-naive patients, the combination of tenofovir with lamivudine and efavirenz has~     been classified as a preferred regimen in the Department of Health and Human Services~     treatment guidelines[4], and has been adopted by the South African Department of health as~     the first line regimen in treatment-naïve HIV infected patients since April 2010. The~     durability of antiviral response, favourable resistance profile, once daily dosing, and~     excellent long term safety profile of tenofovir [5], makes this drug an attractive option in~     both treatment and prevention regimens and its long half-life [6], made it an ideal choice as~     the first antiretroviral drug to be formulated as a microbicide gel.~      The CAPRISA 004 study conducted in South Africa which tested the effectiveness and safety of~     1% tenofovir gel showed that the use of tenofovir in a gel formulation reduced HIV~     acquisition by 39% overall, and by 54% in women with high gel adherence [7]. There have been~     concerns raised regarding the use of tenofovir in both PrEP and treatment regimens due to the~     potential for selection of viral mutations and development of resistance in patients who have~     become HIV-infected while on PrEP.~      There have been no studies conducted to determine whether using tenofovir in pre-exposure~     prophylaxis affects treatment outcomes in patients who later use tenofovir, which is part of~     the first line ART of South Africa.~      This study aims to determine whether prophylactic exposure to tenofovir gel alters the~     therapeutic response to a tenofovir containing antiretroviral regimen.~   "
166451|NCT01387009|"~     The primary objective is to establish normative data for Canadian children for the shoulder,~     elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons~     surrounding the joint.~   "
166452|NCT01386996|"~     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with~     the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.~   "
166453|NCT01386983|"~     This retrospective study aims to assess the clinical and economic impact of early initiation~     of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP)~     receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late~     initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health~     System databases will be utilized for this study (2000-2008).~   "
166454|NCT01386970|"~     This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in~     men versus women and in those with versus without HIV infection. Additionally, markers of~     side effects were correlated with blood levels of the drugs. The hypothesis was that women~     and those with HIV would have higher drug levels, as well as markers of side effects.~   "
166455|NCT01386957|"~     Idiopathic nephrotic syndrome (INS) is the most frequent glomerular disease in childhood.~     Currently, all children with INS are treated at onset with steroids. The optimal duration and~     dosage of steroid therapy is debated. For each patient, the challenge is to minimise~     potential side effects of steroids, while achieving a good clinical response.~      The aim of our study is to assess the benefits and potential adverse effects of a prolonged~     initial corticosteroid regimen, for the treatment of the initial episode. The results will be~     compared with data obtained retrospectively. In addition genetic studies will be undertaken~     with the aim of evaluating pharmacodynamics of steroid treatment with the ultimate goal to~     individualise treatment in single patients.~        1. Study group: children aged 6 months - 18 years, diagnosed with an initial episode of~          idiopathic nephrotic syndrome~        2. Control group: data of children with a onset INS between January 2007 and December 2009~          from the same area of the study group and treated with a short steroid regimen will be~          retrospectively analysed and compared~   "
166456|NCT01386944|"~     The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome~     (RLS) symptoms and augmentation in patients with augmentation associated with previous oral~     dopaminergic therapy. In addition, the change in treatment regimen used when switching to~     Neupro® will be evaluated.~   "
166457|NCT01386931|"~     This study is a multicenter prospective randomized controlled trial. Potential participants~     in this study include patients referred for Endoscopic Ultrasound-guided fine needle~     aspiration (EUS-FNA) of a solid pancreatic lesion at one of the participating centers. If the~     patient meets inclusion criteria and signs the informed consent, they will be randomized into~     one of the two study arms in a 1:1 ratio. Patients will either undergo EUS-FNA with or~     without an on-site cytopathologist present during EUS-FNA. Patients assigned to the on-site~     cytopathologist arm will have the cytopathologist dictate the number of fine needle~     aspiration (FNA) passes performed by the endosonographer. This number will be based on the~     adequacy of specimen and the ability to provide a preliminary diagnosis. In the other arm, in~     the absence of an on-site cytopathologist, the endosonographer will perform a predetermined~     number of 7 passes (standard of care in the absence of an on-site cytopathologist). The~     technique of performing EUS-FNA (needle type, use of stylet, suction) will be standardized~     among all endosonographers in order to rule out confounding factors. After EUS-FNA is~     performed all slides will be sent to the pathology department. The slides will be sent for~     review regardless of which arm the patient is randomized into, and they will be reviewed by~     experienced cytopathologists for the purpose of determining the final diagnoses.~      Future clinical intervention will be monitored for the purpose of reporting the impact~     EUS-FNA has on the patient's clinical course and determining diagnostic accuracy. Patients~     will be followed prospectively for at least one year, and the gold-standard for final~     diagnosis of pancreatic malignancy will be defined by the presence of malignant cytology or~     histologic evidence (if the patient undergoes surgery) or with clinical and/or imaging~     follow-up consistent with pancreatic cancer (death or clinical progression). A detailed~     account of medical equipment used during each procedure, procedure time, clinic~     visits/hospitalizations due to procedure related complications, and number of repeat~     procedures will be recorded systematically.~      The investigators hypothesize that an on-site cytopathologist during EUS-FNA for pancreatic~     masses improves diagnostic yield, accuracy, and lowers the duration, complications and the~     need for repeat procedures.~   "
166458|NCT01386918|"~     Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for~     refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of~     studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz)~     to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation~     (hereby simply referred to as priming) has been shown to enhance the neurophysiological~     effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore,~     this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to~     the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).~   "
166459|NCT01386905|"~     The purpose of this study is to assess the feasibility of the TransPyloric Shuttle™ (TPS™)~     when used to treat obesity.~   "
166460|NCT01386892|"~     This study seeks to obtain normal samples of blood, saliva and urine to serve as controls for~     other approved protocols and for analysis. These include determination of the functional~     capabilities of cells, proteins, nucleic acids and microvesicles obtained from peripheral~     blood including plasma, serum and cellular fraction from normal individuals. Saliva and urine~     will have similar testing which may also be compared to the blood testing results. The~     ongoing objective varies from investigation to investigation but in general the~     investigational goals are to better understand the immune function of normal volunteers and~     compare it to immune function in disease states.~   "
166461|NCT01386879|"~     The aim of this prospective, randomized, pilot study is compare ease of tracheal intubation,~     amount of microaspiration and efficacy of secretion removal using three FDA (Food and Drug~     Administration)-cleared endotracheal tubes (ETT) after the induction of general anesthesia in~     the operating room (OR). Studies in the intensive care unit (ICU) have demonstrated a~     significant reduction in the incidence of ventilator acquired pneumonia when a ETT with~     suction above the cuff is used to remove secretions that accumulate above the inflated cuff.~     This will be the first study to evaluate the efficacy of above the cuff suctioning during~     general anesthesia and surgery.~      One hundred and ten adult patients undergoing elective abdominal surgery (general, colorectal~     or gynecological) requiring general anesthesia with an endotracheal tube and mechanical~     ventilation will be randomized into 3 groups to receive one of the following three~     endotracheal tubes:~        1. Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port~          Endotracheal Tube (Teleflex ISIS ETT).~        2. Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT).~        3. Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT)~      The first two groups will be compared to standard ETT (third group) regarding easy of~     tracheal intubation, efficacy of suctioning of secretions, efficacy of sealing the trachea~     with an inflated ETT cuff by preventing the movement of test dye (methylene blue) from the~     pharynx into the trachea and incidence of post-operative respiratory complications.~   "
166462|NCT01386866|"~     In order for a tumour to grow and spread to other parts of the body, it needs to have a blood~     supply. Certain proteins in the body, called cytokines or growth factors, have been shown to~     cause the growth of new blood vessels that supply tumours and therefore help the tumour to~     grow and spread. Motesanib (AMG 706) prevents these proteins from working, and may help to~     prevent the growth of tumours.~      In the first part of this study, we will look at the way your body absorbs this drug into~     your blood, how your body changes and breaks down the drug, and then how the drug leaves your~     body in your urine and faeces.~      In order to provide potential treatment benefit for the subjects who participated in the~     first part of the study, the second part of the study will allow subjects to continue on~     motesanib (AMG 706) treatment. The estimated length of this part of the study is unknown, and~     dependent on how subjects respond to motesanib (AMG 706).~   "
166463|NCT01386853|"~     This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority~     study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and~     atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.~   "
166464|NCT01386840|"~     The purpose of this study is to determine the safety and efficacy of oral amoxicillin in~     treating WHO defined severe pneumonia(cough and fast breathing with lower chest indrawing) at~     home and at hospital using an open labelled multicentric prospective two-arm randomized~     clinical trial to determine the differences in failure of treatment with a 7 day course of~     oral amoxicillin administered for first 48 hours in the hospital in comparison to being sent~     home after enrolment, in children 3 to 59 months old who have severe pneumonia. The~     investigators developmental hypothesis were to test whether the community/home based oral~     amoxicillin is efficacious for treating severe pneumonia.~   "
166465|NCT01386827|"~     The old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to~     cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The~     present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro.~      Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune~     responses in four groups: A) primary immunization with BMJEV, B) primary and secondary~     immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization~     with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help of~     serum samples collected before and after vaccination.~   "
166466|NCT01386814|"~     Aim: To evaluate the influence of oxygen deficit on the cognitive performance and also about~     the architecture and sleep efficiency in volunteers subjected to mild and moderate exercise~     in a hypobaric chamber. SUMMARY: Participants in this study 30 healthy male volunteers, aged~     20 to 40 years, regular physical activity, constituting three groups: 1 - without~     exercise-hypoxia group 10 volunteers who not be subjected to any kind of physical exercise in~     hypoxia and remain all day of experiment, 2 - group exercise at sea level, is composed of 10~     volunteers who will undergo a protocol exercise physical sea-level, 3 - group exercise and~     hypoxia - 10 volunteers who will carry out a protocol exercise on a treadmill, being the same~     in condition of hypoxia (hypobaric chamber). All groups on the first day of the experiment~     will undergo baseline assessments, laboratory blood analysis salivary and spirometric~     testing. Assessments will be personality and neuropsychological. After baseline assessments,~     the last day of the experiment, the groups will be evaluated again 4350m above sea level the~     sea, by personality tests, neuropsychological and laboratory. RATIONALE AND BACKGROUND:~     During exposure to environments with a partial reduction of oxygen, human body can undergo~     several physiological and psychological changes are not prepared for such condition. Few~     studies have reported that the elevation changes and cognitive aspects related to sleep.~      MATERIAL AND METHOD: They describe the procedures to be performed, and the study conducted in~     local with adequate infrastructure.~   "
166473|NCT01386723|"~     This study proposes to observe whether a stable platelet count would be maintained without~     additional treatment in the long term in at least a proportion of patients who have~     discontinued eltrombopag taken for at least 4 months. This requires that if patients stop~     treatment with eltrombopag, they are not immediately transitioned to further treatment unless~     it is necessary.~      The objective of the study is to assess how frequently patients who have discontinued~     eltrombopag attain a stable, treatment-free, unmaintained adequate platelet count 4 to 8~     weeks after discontinuing eltrombopag and how long such a response lasts (if it occurs).~   "
166467|NCT01386801|"~     Blood samples and health information (e.g., age at diagnosis, test results) are collected for~     the purposes of genetic research. The blood samples are assigned a number and stored in a~     repository for safe keeping until they are needed for a research project. Participants are~     persons who are healthy (not having high blood pressure, diabetes, or high cholesterol~     levels) or persons who have Diabetes Mellitus Type II(T2D) and live in Indiana. Participants~     complete a questionnaire at the time the blood sample is drawn. Visits are repeated at 2 and~     5 years after initial contact. Researchers apply to the Fairbanks Institute for use of the~     blood samples and health information minus participant names and contact information. Their~     research is required to be related to find genes or substances made by genes that may be~     involved in Diabetes Mellitus Type II with the purpose of improving the investigators~     understanding of the illness potentially leading to the development of new diagnostic tools~     for identifying the illness, new treatments,or preventative measures.~   "
166468|NCT01386788|"~     Cyanide poisoning is commonly viewed as a rare but dramatic event, occurring in industrial or~     laboratory settings as the result of accidental releases of hydrogen cyanide (HCN) gas (e.g.~     in the case of fire) or salts in the case of suicide attempts.~      In fact, cyanide poisoning is considerably more common than is generally appreciated.~     Multiple clinical and post-mortal studies have demonstrated that HCN contributes to the~     toxicity of fire smoke.~      Cyanide acts primarily through its strong affinity for the iron-containing heme moiety,~     binding to numerous critical enzyme systems in the body and rendering them inactive. Of late,~     increasing attention has been paid to the relationship of cyanide and nitric oxide. The~     interactions appear to be complex, with cyanide inducing nitric oxide production by binding~     to N-methyl-D-aspartate (NMDA) receptors, as well as binding to nitric oxide synthase. The~     latter may be overcome by the presence of nitric oxide synthase inhibitors.~      Probably, the majority of the cyanide poisoning cases are due to smoke inhalation in~     closed-space fires.~      So far, there are no clear data available on the prevalence of cyanide poisoning in smoke~     inhalation.~      This information would be of great interest for all emergency physicians since a proven or~     supposed cyanide poisoning does not only requires an intensive supportive care, including the~     administration of supplemental oxygen and artificial ventilation, blood pressure support, and~     anticonvulsants, but also a rapid administration of a cyanide antidote.~      Therefore, it is the goal of this survey to assess the prevalence of cyanide poisoning in~     smoke inhalation victims. Only the data of patients with a cyanide measurement before~     specific antidote treatment will be included~   "
166469|NCT01386775|"~     This study in affected Hypohidrotic Ectodermal Dysplasia (HED) males and unaffected male~     controls, age 1 year and up, will use minimally invasive devices to image sweat ducts in~     intact skin, to measure stimulated sweat rate, and in a subset of subjects to collect clipped~     scalp hair samples for RNA analysis. This study is descriptive in nature and is intended to~     assess the ability to use innovative approaches to generate data from subjects over a wide~     age spectrum, with particular emphasis on phenotype variability between male siblings (same~     mutation).~   "
166470|NCT01386762|"~     Bone loss is a common secondary complication of spinal cord injury (SCI), and treatments used~     to reverse this condition have equivocal effectiveness. The aim of this study is to determine~     the effect of intense multi-modal training on bone health, body fat, and quality of life in~     persons with SCI. Participants will complete 6 months of training during which various~     measures will be obtained at 0, 3, and 6 months. Control subjects are also being recruited to~     complete testing but not participate in training.~   "
166471|NCT01386749|"~     Diaphyseal long bone fractures are usually associated with high energy trauma in which~     femoral shaft fracture is one common fracture in young age group. Surgery is usually needed~     for the diaphyseal lone bone fractures and the painful conditions always hinder weight~     bearing which is important for fracture healing and functional recovery. Fracture healing in~     cortical bone is less predictable than trabecular bone because they are less active and blood~     supply is more critical. Therefore accelerating fracture healing and rehabilitation of long~     bone fracture will absolutely bring significant economic benefit to the society in term of~     hospitalization and sick leave cost.~      Low-magnitude, high-frequency vibration (LMHFV) treatment can provide systemic mechanical~     stimulation and is reported with multiple effects on musculoskeletal tissues. LMHFV can~     enhance the blood circulation and osteogenic effect in normal subjects and animals. Our~     previous clinical study also indicated that LMHFV could enhance the balancing ability and~     muscular function in normal post-menopausal women after treating whole-body vibration. For~     the fracture healing effect, an acceleration of healing by inducing callus formation and~     maturation in rat model was also reported in our previous studies.~      In this study a total of 50 unilateral closed femoral shaft fracture patients of either~     gender aged 20-40 years old will be recruited and they will be randomized to either control~     and vibration group. The vibration group will be treated with LMHFV for 6 months. The~     findings of this study will provide very useful scientific data to support the application of~     LMHFV for fracture healing.~   "
166472|NCT01386736|"~     The discovery that the vitamin D receptor is expressed in more than 30 tissues indicates that~     the physiologic functions of vitamin D are much broader than its well-known role in the~     regulation of calcium absorption and bone metabolism. There is evidence that vitamin D is~     involved in the pathogenesis of cancer, cardiovascular disease, multiple sclerosis, and type~     I diabetes. Recent epidemiological evidence points to a strong association between vitamin D~     insufficiency and insulin resistance, the metabolic syndrome, and type II diabetes. The~     investigators would like to examine the role of vitamin D in the development of insulin~     resistance in overweight children and adolescents, which represent a high risk population for~     cardiovascular and metabolic complications. The investigators propose a prospective~     randomized clinical trial of vitamin D supplementation in overweight, insulin resistant,~     vitamin D deficient children. The investigators objective is to assess if changes in insulin~     resistance, fasting lipid profiles, blood pressure, and inflammatory markers occur in these~     patients post treatment with vitamin D. Additionally, concomitant changes in calcium and bone~     metabolism after vitamin D treatment will be evaluated. This is because, contrary to adults,~     the optimal vitamin D concentrations that regulate calcium and bone metabolism have not been~     established in pediatrics.~   "
168031|NCT01366222|"~     The purpose of this study is to determine whether food concentrates supplementation~     (vegetable plus fruit, fish, probiotics) are effective to alleviate drug used, asthma~     symptoms and lung function in children due to asthma.~   "
166474|NCT01386710|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic~     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of~     tumors also exhibits the most aggressive behavior, resulting in median overall survival~     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of~     either surgical resection, external beam radiation or both. All patients experience a~     recurrence after first-line therapy, so improvements in both first-line and salvage therapy~     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently~     used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators~     have shown in a previous phase I trial that a single Superselective Intraarterial Cerebral~     Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of~     recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that~     trial in that the investigators seek to test the hypothesis that repeated dosing of~     intra-arterial Bevacizumab is safe and effective in the treatment of recurrent malignant~     glioma. Additionally the investigators will analyze if a combination with IA Carboplatin will~     further improve the treatment response. By achieving the aims of this study the investigators~     will also determine if IV therapy with Bevacizumab with IV Carboplatin should be combined~     with repeated selected intra-arterial Bevacizumab plus Carboplatin to improve progression~     free and overall survival. The investigators expect that this project will provide important~     information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma,~     and may alter the way these drugs are delivered to the investigators patients in the near~     future.~   "
166475|NCT01386697|"~     The overall objective is to estimate the actual or potential benefit of deep inspiration~     breath holding (DIBH) treatment in the context of proton radiotherapy as compared to 3~     dimensional conformal radiation therapy (3DCRT) and intensity-modulated x-ray therapy (IMXT),~     as it relates to variability in tumor localization, treatment margins, target volume~     definition, doses to organs at risk and variations with treatment planning.~   "
166476|NCT01386684|"~     The purpose of this study is to evaluate the Canadian Real Life Evaluation of the~     Effectiveness of Lupron in the Management of Prostate Cancer.~   "
166477|NCT01386671|"~     The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus~     Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican type 2~     diabetes patients, in a 12 months follow up.~   "
166478|NCT01386658|"~     HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the~     Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single~     subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with~     Hereditary Angioedema (HAE) during an initial acute attack.~   "
166479|NCT01386645|"~     The study will determine if increasing the highs and lows of blood glucose levels (glycemic~     variability) impairs insulin secretion in people with impaired glucose tolerance and/or~     impaired fasting glucose who are at risk for developing type 2 diabetes. Furthermore, the~     study will determine whether changes in beta-cell function are associated with glycemic~     variability and whether they are mediated by oxidative stress. To decrease or increase~     glycemic variability the study will provide subjects with special diets containing either low~     or high glycemic index foods respectively for 4 weeks. To determine if oxidative stress is a~     mediator, subjects on the high glycemic index diet will take either placebo or the~     anti-oxidant N-acetylcysteine. The study will address the hypothesis that increased glycemic~     variability results in increased oxidative stress and thereby exacerbates beta-cell~     dysfunction in individuals with impaired glucose tolerance and/or impaired fasting glucose.~     The findings may have important implications for the development of effective strategies~     aimed at the prevention and treatment of type 2 diabetes. In addition, understanding the~     contribution of dietary glycemic index to beta-cell dysfunction in subjects with pre-diabetes~     may have a significant public health impact, including changes to dietary counseling and~     promotion of healthier eating patterns.~   "
166480|NCT01386632|"~     This will be a randomized masked placebo-controlled single-center study to evaluate the~     effects of Dichloroacetate (DCA) versus placebo given in combination with Cisplatin and~     radiation treatment in patients with Stage III-IV Squamous Cell Carcinoma of the Head and~     Neck (SCCHN). Fifty subjects will be enrolled and randomly assigned on a 1:1 ratio to DCA or~     matching placebo given with standard of care treatment consisting of Cisplatin and radiation~     treatment.~      Patients will receive DCA/placebo PO or per G-tube twice a day for 8 weeks. The first 6~     patients of the total study population will represent a safety lead-in cohort. The results of~     the safety lead-in of DCA/placebo in combination with Cisplatin and radiation therapy will be~     evaluated after the 6th patient has completed 8 weeks of therapy. Recruitment of patients~     will be withheld during safety data analysis.~   "
166481|NCT01386619|"~     This is a phase I/II study of highly selected donor lymphocyte infusions in patients~     undergoing HLA-haploidentical hemopoietic stem cell transplantation. Patients will be offered~     pre-emptive NK-DLI early after HSCT.~      Three schedules of NK-cell infusion will be studied: Basel patients (adult and pediatric)~     will receive NK-DLI on days +40 and +100 (pre-emptive-late); Frankfurt patients (pediatric)~     will receive NK-DLI on days +3, +40, and +100 (pre-emptive early). Patients not receiving~     pre-emptive NK-DLI with loss in donor chimerism or with evidence of minimal residual disease~     will be offered therapeutic NK-DLI.~   "
166482|NCT01386606|"~     The study will determine the effects of three doses of Androxal(enclomiphene citrate)on~     morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone~     (<350 ng/dL)after 6 weeks of continuous dosing.~   "
166483|NCT01386593|"~     The purpose of this study is to assess how the pharmacokinetic profiles of each drug of a~     cocktail of six approved drugs (so-called Basel cocktail) change when the cytochrome P450~     system is inhibited or induced.~   "
166484|NCT01386580|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK)~     of 2B3-101 both as single agent and in combination with trastuzumab. Furthermore, the study~     will explore the preliminary antitumor activity of 2B3-101 as single agent in patients with~     with solid tumors and brain metastases or recurrent malignant glioma as well as in patients~     with various forms of breast cancer with and in combination with trastuzumab in HER2+ breast~     cancer patients with brain metastases.~   "
197069|NCT00983827|"~     This study aims to determine if Aquatic Treadmill Therapy is effective for improving economy~     of gait, gait speed, balance, and cardiovascular fitness in people with chronic stroke.~   "
166485|NCT01386567|"~     The purpose of this study is to determine the continued effects of Androxal on morning~     testosterone and reproductive status in men with secondary hypogonadism who have completed~     protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim~     (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5~     mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the~     lower dose.~   "
166486|NCT01386554|"~     The purpose of this study is to provide nephrologists with additional clinical evidence~     regarding the efficacy and safety of Acthar in subjects with treatment-resistant idiopathic~     membranous nephropathy. Approximately sixty (60) subjects will be randomized in this~     double-blind, parallel-group, placebo-controlled, multicenter study comparing Acthar and~     Placebo administered 2 times per week for a 24-week treatment period followed by a 24-week~     observation period. The primary objective of this study is to assess the proportion of~     treatment-resistant subjects (defined as subjects who either have had no response or have~     suffered a relapse after achieving a partial response to their most recent standard treatment~     regimen) who have a complete or partial remission of proteinuria in nephrotic syndrome due to~     idiopathic membranous nephropathy after 24 weeks of treatment.~   "
166487|NCT01386541|"~     This monocenter trial is conducted to obtain first data on safety, tolerability,~     pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677~     in humans. In addition, the trial should provide preliminary information on a possible~     influence of sex, food intake, and posology (once or twice daily administration of BYK324677)~     to support the further planning of the drug development programme.~   "
166488|NCT01386528|"~     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).~      The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog~     beta pegol) during surgical procedures in patients with haemophilia B.~   "
166489|NCT01386515|"~     Background:~      We want to learn more about the relationship between the way families function and how~     children adapt to having a sibling with Duchenne muscular dystrophy (DMD). What we learn will~     help us design better interventions for families.~      Objective:~        -  To learn more about how families with an individual with DMD function.~        -  To learn how siblings adapt in families with an individual with DMD.~      Eligibility:~        -  One parent and one child, age 13-18, from a family where another child has DMD.~        -  The parent and the child must be able to read and write English.~      Design:~        -  One parent from each family will complete a survey about how family members communicate~          and relate with each other. The parent will also answer questions about the behavior of~          the child without DMD. This survey will take you about 40 minutes to complete.~        -  One child from each family, either a boy or a girl, will also complete a survey. This~          survey asks about how he/she views him/herself. It also asks about how he/she interacts~          with peers and family members and how he/she behaves. The survey also asks how satisfied~          he/she is with how his/her family functions. This survey takes about 30 minutes to~          finish....~   "
166490|NCT01386502|"~     Background:~        -  The p53 gene normally helps to stop cancer cells from growing. However, when the p53~          gene is mutated or damaged, cancer cells may grow unchecked. Researchers have been~          working on a vaccine that will help the immune system recognize and destroy cells that~          have the p53 mutation and may be cancerous.~        -  CT-011 is another drug that may help the body's immune system to fight cancer. This drug~          blocks a chemical found on tumor cells that prevents the immune system from recognizing~          and destroying them. Research studies have shown that CT-011 slows the growth of tumors.~          By combining the p53 vaccine and CT-011, researchers hope to slow or stop tumor growth~          in people whose cancer that has not responded to standard treatments.~      Objectives:~      - To test the safety and effectiveness of CT-011 and the p53 genetic vaccine to treat adults~     with solid tumors that have not responded to standard treatments.~      Eligibility:~      - People at least 18 years of age who have solid tumors that have not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests and tumor imaging studies.~        -  Participants will receive the p53 vaccine as an injection in the arm or thigh.~        -  Two days after receiving the p53 vaccine, those in the study will receive CT-011 as an~          infusion over about 2 hours. Participants will be monitored during the infusion for any~          side effects.~        -  The combination of p53 vaccine and CT-011 will be repeated every 3 weeks (one cycle).~          Treatment will continue as long as the side effects are not severe and the tumor does~          not grow.~        -  Three weeks after the second dose of p53 vaccine and CT-011, participants will have a~          full physical exam. They will also have blood tests, and tumor imaging studies. This~          exam set will be repeated after every two cycles of p53 vaccine and CT-011.~        -  Participants will have regular follow-up visits for up to a year after stopping~          treatment.~   "
166491|NCT01386489|"~     Background:~      The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for~     HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response~     to two experimental HIV vaccines currently in development at the VRC. One is known as the~     rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces~     of manufactured DNA. They do not contain live or killed HIV. It is impossible for study~     vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these~     experimental vaccines have been given to people before in other research studies. They have~     not been approved for treating or preventing HIV infection.~      Purpose:~      The main purpose of this study is to look in detail at the body s immune responses after the~     experimental HIV vaccines are given and to assess safety of the study vaccines.~      Eligibility:~      Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet~     the eligibility requirements.~      Design:~      Participants will be screened with a medical history (including questions about sexual~     history and drug use), physical exam, and blood tests.~      The study will have two groups:~      <TAB>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over~     3 months.~      <TAB>The second group will have three injections of the DNA vaccine, one injection of the~     rAd5 vaccine, and have 12 clinic visits over 6 months.~      All participants will be asked to provide blood and body fluid samples for testing during the~     study.~      Payment for participation will be provided.~   "
166523|NCT01386047|"~     Clinical prediction rules (CPRs) are frontline decision aids that help physicians make~     evidence-based, cost-effective decisions that benefit their patients. The aims of this~     project are to incorporate two well validated CPRs (Streptococcal Pharyngitis Prediction Rule~     and the Pneumonia Clinical Prediction Rule) into an outpatient Electronic Medical Record~     System (EMR) and to perform a randomized controlled trial of the effectiveness of integrated~     CPRs impact on doctor's behaviors (e.g. test ordering and medication prescribing).~   "
166524|NCT01386034|"~     The specific aim of this study is to determine whether oral citrulline administration~     enhances whole body protein synthesis in patients with intestinal failure. Protein metabolism~     will be assessed using an intravenous infusion of stable isotope labeled leucine. The~     investigators hypothesize that citrulline supplementation will decrease leucine oxidation~     without altering proteolysis, and consequently stimulate protein synthesis.~   "
166492|NCT01386476|"~     Background:~      - The blood-brain barrier helps protect the brain from infections and toxins in the blood~     stream. But it can also prevent certain drugs from reaching the brain to treat diseases or~     other problems. Researchers are interested in chemicals that will help show how the barrier~     works. One possible chemical, (18F)FCWAY, may be useful for studying the barrier. More tests~     are needed to determine how effective it is.~      Objectives:~      - To test whether (18F)FCWAY can be used to help study the blood-brain barrier.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age.~      Design:~        -  This study requires a screening visit and two scanning visits.~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  At the first scanning visit, participants will have a magnetic resonance imaging scan to~          provide baseline images of the brain.~        -  Before the second visit, some participants will stay overnight in the hospital. They~          will receive the drug tariquidar, which may help the (18F)FCWAY show the blood-brain~          barrier more clearly.~        -  At the second scanning visit, all participants will have a positron emission tomography~          scan with (18F)FCWAY to see how well the drug shows the blood-brain barrier on the scan.~   "
166493|NCT01386437|"~     Background:~      - The immune system is made up of special cells, tissues, and organs that fight infections.~     Problems with this system may lead to frequent, severe, or unusual fungal infections. These~     infections are often difficult to treat. Researchers want to collect blood and tissue samples~     from people who have unusual, persistent or severe fungal infections or immune problems that~     increase the risk of these infections.~      Objectives:~      - To collect medical information and samples for a long-term study of people with immune~     system problems that lead to fungal infections.~      Eligibility:~        -  People with a history of fungal infections caused by immune system problems.~        -  Parents, children, and siblings of this group.~        -  Healthy volunteers not related to the first two groups.~      Design:~        -  This long-term study may last for up to 10 years. Those in the study may need to provide~          new information about every 6 months. The procedures for each person may vary with the~          particular diagnosis and the extent of fungal infection. Healthy volunteers may have~          only one or two visits.~        -  At the first visit, those in the study will have a full medical history and physical~          exam. They will also provide blood.~        -  Research procedures may include the following:~        -  Saliva, urine or stool testing~        -  Mouthwash collection for DNA testing~        -  Collection of cheek cells, nail clippings, or vaginal fluid~        -  Tests of leftover tissue or body fluid from previous medical procedures~        -  Skin or oral mucous membrane biopsy~        -  Collection of white blood cells~        -  Followup visits will involve a physical exam and updated medical history. Blood, saliva,~          urine, or nail clipping samples may be taken for ongoing studies. Any additional tests~          or exams required by the study doctors may also be done.~        -  Participants may withdraw from the study pool at any time.~   "
166494|NCT01386424|"~     Background:~        -  The Laboratory of Infectious Diseases (LID) Clinical Studies Unit (CSU) enrolls healthy~          volunteers into clinical studies to study infectious diseases.~        -  Viruses can be highly infectious and contagious. They cause considerable illness in the~          United States each year and a good example of this is influenza (the flu). The LID CSU~          performs clinical studies to learn about these viral infections and assist in the~          development of vaccines and treatments for the infections. These clinical studies~          include influenza challenge studies as well as natural history studies and phase I~          trials involving vaccines for viruses carried by mosquitos such as Zika or Dengue virus.~        -  In influenza challenge studies studies, doctors expose a person to a flu virus. Then~          they study the flu through the body's natural healing process. This information will~          help to find better ways to prevent the flu and may also improve treatments for the flu.~        -  Natural history studies and phase I trials of new vaccines are performed so the~          researchers can learn how some viral infections occur and if new vaccines are safe and~          potentially effective in preventing the infections. In some of these studies,~          participants experience insect bites with special clean (non-infected) insects (such as~          mosquitos) to better understand the role of insects in these infections.~      Objectives:~      - To screen healthy volunteers for future CSU studies.~      Eligibility:~      - Healthy people between the ages of 18 and 65~      Design:~        -  The 3- to 5-hour screening exam includes the following:~        -  Medical history and physical exam~        -  Standard blood tests including pregnancy, Hepatitis B and C, and HIV tests~        -  Standard urine drug testing~        -  Electrocardiogram (ECG) to test heart rhythm and function~        -  Chest x-ray~        -  Eligible volunteers are enrolled in the study for up to 1 year, until they take part in~          a CSU study or are found to be ineligible to participate.~        -  Volunteers may withdraw from the study pool at any time.~   "
166495|NCT01386411|"~     Genes are the blueprints for our bodies. Some people are born with an abnormal copy~     (mutation) of a gene. These people may have a higher chance of getting a disease. Different~     mutations in different genes cause different diseases. Some women get breast cancer because~     they are born with an abnormal copy of a gene called BRCA1 or BRCA2. These women also have a~     higher chance of getting ovary cancer. Women with breast cancer and an abnormal copy of BRCA1~     or BRCA2 also have a higher chance of getting a second breast cancer in their other breast.~     Because of this, women who might have a mutation may have genetic testing soon after their~     breast cancer diagnosis to learn about their risks of getting another cancer.~      Genetic testing may be done right after a woman has been diagnosed with breast cancer. It may~     also be done later, after surgery is done to treat the cancer. The investigators do not know~     when it is best to do genetic testing. The investigators are doing this study to try to~     understand whether women prefer testing before or after surgery. The investigator also want~     to find out how they feel about their choice later on, when their diagnosis in more in their~     past.~   "
166496|NCT01386398|"~     RATIONALE: Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. It is not yet known whether vorinostat is more effective~     when given alone or when given together with bortezomib in treating patients with refractory~     or recurrent cutaneous T-cell lymphoma.~      PURPOSE: This randomized phase III trial is studying how well vorinostat works when given~     alone compared with vorinostat given together with bortezomib in treating patients with~     refractory or recurrent stage IIB, stage III, or stage IV cutaneous T-cell lymphoma.~   "
166497|NCT01386385|"~     This phase I/II partially randomized trial studies the side effects and best dose of~     veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see~     how well it works in treating patients with stage III non-small cell lung cancer that cannot~     be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells~     and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in~     different ways to stop the growth of tumor cells either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether radiation~     therapy, carboplatin, and paclitaxel are more effective with or without veliparib in treating~     non-small cell lung cancer.~   "
166525|NCT01386021|"~     The primary objective of this observational study is to evaluate the function (patency) of~     cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for~     patients with occlusive coronary artery disease.~   "
166526|NCT01386008|"~     The purpose of this study is to evaluate the performance of the investigational CooperVision~     silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to~     30 days of daily lens wear.~   "
166596|NCT01385085|"~     Three types of workers exposed to different levels of natural sunlight will be tested for~     Vitamin D blood level, PTH, Ca, P, albumin and alkaline phosphatase.~      In addition, each tested worker will be asked to fill a questionnaire for demographic,~     medical and personal habit information.~   "
166498|NCT01386372|"~     Hyponatremia is a common electrolyte disorder encountered in hospitalized patients. A~     preliminary, observational, feasibility analysis finalized to assess retrospectively the~     incidence of hyponatremia (Serum sodium < 135 mEq/L) in a general medical-surgical hospital~     and the distribution of the cases of hyponatremia among different referral units showed that~     over one year observation there were more than 1500 cases of hyponatremia. Conventional~     therapy for hyponatremia depends on its causes, speed of onset, extracellular fluid volume~     status, and severity. Treatment consists in fluid restriction, normal or hypertonic saline,~     furosemide. Recent development of arginine vasopressin antagonists has provided a new~     therapeutic option for treatment of hyponatremia.Tolvaptan, an orally administered,~     nonpeptide, selective vasopressin V2 receptor antagonist reported to increase free water~     clearance and limit fluid retention in subjects with congestive heart failure or liver~     cirrhosis, has been also shown to be effective in the treatment of chronic hyponatremia in~     patients with SIADH, chronic heart failure, liver cirrhosis. Thus the investigators designed~     a clinical study to explore the incidence of severe hyponatremia in hospitalized patients in~     the setting of large general hospital and to evaluate whether tolvaptan is effective and safe~     in increasing serum sodium concentration in patients with normovolemic and hypervolemic~     hyponatremia in the setting of daily clinical practice. Moreover this study may help~     understand the cost-effectiveness of tolvaptan therapy compared to traditional treatments of~     hyponatremia.~   "
166499|NCT01386359|"~     To describe how Nulojix (belatacept) is used and to determine how often Post-Transplant~     Lymphoproliferative Disorder (PTLD), Central Nervous System (CNS) PTLD and Progressive~     Multifocal Leukoencephalopathy (PML), rare and serious complications of transplant treatment,~     occur in patients taking Nulojix (belatacept) in a real-world setting.~   "
166500|NCT01386346|"~     The purpose of this study is to see whether giving azacitidine before each cycle of~     chemotherapy prior to surgery is safe.~   "
166501|NCT01386333|"~     Oxytocin is a hormone produced by the brain that appears to have important roles in social~     cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin~     on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia~     were investigated. The results from the pilot study suggested that oxytocin may be associated~     with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal~     Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the~     present study will examine the safety and tolerability of three different doses of intranasal~     oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.~   "
166502|NCT01386320|"~     Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and~     is very painful. Local anaesthetic nerve blocks have been used for many years to help~     alleviate pain following this surgery. The present study aims to compare a new ultrasound~     guided nerve block to a well established nerve stimulator guided technique. Comparisons will~     include time taken to carry out the block, speed of onset of numbness and duration and~     quality of pain relief after surgery.~   "
166503|NCT01386307|"~     The purpose of this study is to determine the prevalence of patients with acute and chronic~     pain in the area of inpatient at the Hospital Italiano de Buenos Aires.~   "
166504|NCT01386294|"~     The purpose of the study is to assess the safety and effectiveness of intravaginal 1%~     tenofovir gel in preventing Human Immunodeficiency Virus (HIV-1) infection and Herpes Simplex~     Virus (HSV-2) infection in sexually active women.~   "
166505|NCT01386281|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Julina for postmenopausal~     osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in~     clinical practice. A total 100 patients will be recruited and followed 3 years since starting~     Julina administration.~   "
166506|NCT01386268|"~     To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life~     conditions in its registered indications.~      The observation period for each patient is up to 6 months.~   "
166507|NCT01386255|"~     Despite the use of proton pump inhibitors and available prokinetics, medical therapy is~     ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal~     reflux disease (GERD), and failure of medical therapy is associated with a substantial~     morbidity. Many patients, particularly children with CP and GERD, continue to experience~     complications despite aggressive therapy because antisecretory medications do not address the~     primary reflux mechanism (TLESR). Furthermore, in patients with CP, surgical options are~     fraught with serious complications and long-term morbidity. Because the available treatment~     options for children with CP and intractable GERD are limited, new therapies are urgently~     needed. Baclofen, which has been shown in animals and humans to decrease TLESRs, may be a~     good alternative for the treatment of children with CP with intractable GERD.~   "
166508|NCT01386242|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor~     and anti-virus protein for injection in treating patients with metastatic colorectal cancer~     after failure of second-line and more than second-line treatment.~   "
166509|NCT01386229|"~     The aim of this study is to determine whether ketamine is an acceptable alternative to~     etomidate for anesthesia induction in coronary artery bypass graft surgery in terms of~     hemodynamic stability and also to compare these agents regarding their effect on adrenal~     gland steroid synthesis in these patients.~   "
166510|NCT01386216|"~     The purpose of this study is to evaluate the safety of administration of marrow-derived~     autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for~     the treatment of Critical Limb Ischemia (CLI).~   "
166527|NCT01385995|"~     The investigators performed a randomized, cross-over controlled clinical trial comparing 8~     weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with~     moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A~     rigorous assessment of metabolic responses to SDB treatment in this group is of great~     clinical significance because this sample is at high risk for developing diabetes. The~     paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of~     both primary care and sleep medicine.~   "
168115|NCT01365104|"~     The purpose of this study is determine if the iron chelator, desferrioxamine can increase~     blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there~     is a corresponding increase in blood flow to the brain.~   "
166511|NCT01386203|"~     Analysis of volatile organic compounds (VOCs) is a new attractive non-invasive field in~     medical diagnostics. These VOCs can be detected via the exhaled breath.~      Together with Prof Haick group at the Technion Inst (Israel), the investigators data shows~     that there is a relation between the VOCs patterns of NSCLC and control cell lines and~     equivalent states in exhaled breath. The investigators demonstrated that there is a clear~     discrimination between the lung cancer and the healthy clusters . The investigators also~     analyzed the headspace of NSCLC and SCLC cell lines and the investigators could discriminate~     significantly between SCLC versus NSCLC based on their VOCs patterns. This analysis allowed~     us to identify the specific VOCs consumed or omitted by cancerous cells. Therefore, a~     non-invasive and highly sensitive test would be extremely valuable for the classification and~     early screening of lung cancer and for targeted therapy. In this study, the investigators~     will monitor the VOC pattern of patients with lung cancer as well as high risk cohort and~     patients under risk/evaluation for lung cancer. Likewise the investigators will monitor pts~     under and after therapy. In addition, the investigators will compare teh breath signature to~     other biomarkers of lung cancer, like circulating tumor cells and others.~   "
166512|NCT01386190|"~     This research consists of a novel intervention designed to increase physical activity of~     premature babies in their first year of life. The potential beneficial impact of augmented~     physical activity on:~        1. Body composition~        2. Associated biochemical and cellular mechanisms of growth and inflammation~        3. Quality of maternal care will be measured~   "
166513|NCT01386177|"~     The purpose of this study is to determinate the effect of a pre-treatment with doxazosin, a~     alpha1-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of~     3,4-methylenedioxymethamphetamine (MDMA, ecstasy). The investigators hypothesize that~     doxazosin will attenuate the cardiovascular and subjective response to MDMA.~   "
166514|NCT01386164|"~     The purpose of this study is to analyze and compare the immunogenicity of Bivalent and~     Tetravalent vaccines against Human Papillomavirus in HIV-infected adult persons.~   "
166515|NCT01386151|"~     This study will look at the permeability, or 'leakiness' of the airway epithelium (the inner~     lining of the lung) in asthmatic patients. Increased leakiness of this lining has been shown~     in asthmatic patients by other studies, not only in the lung but also possibly in the gut,~     perhaps reflecting a widespread defect. This leakiness may underline the interaction between~     the environment and a person's genetic make up, and may contribute to why some people get~     asthma, and how severe it is. Increased leakiness may allow increased exposure to inhaled~     allergic substances, helping to perpetuate the inflammation in the lungs that is a hallmark~     of asthma.~      Specifically, this study will attempt to modify and reduce this permeability through the use~     of a substance called 'keratinocyte growth factor', or 'kgf'. KGF is a naturally occuring~     human protein, which is involved in stimulating the growth of cells lining the layers of the~     skin and gut, helping to repair damage and maintain their structure. It has been manufactured~     in a laboratory as the commercial compound 'Palifermin', which has already been used in~     humans to reduce damage to the lining of the mouth after chemotherapy. The study will see if~     Palifermin can similarly improve the lining of the lung in asthma patients and improve their~     symptoms. To date no treatments have been used in this area in asthma, and if successful the~     study will open up a whole new area of therapy~   "
166516|NCT01386138|"~     The purpose of this study was to develop and initially evaluate an efficacious,~     comprehensive, culturally sensitive, women-centered model of care for pregnant South African~     women by adapting and refining PI Jones' Reinforcement-Based Treatment (RBT) model, at the~     same time integrating into it the HIV prevention components of Co-I Wechsberg's Women's~     Health CoOp (WHC) model, yielding an integrated treatment and prevention model, RBT+WHC.~   "
166517|NCT01386125|"~     This study will evaluate the effectiveness and safety of MFNS in improving nasal~     congestion/obstruction and in reducing bilateral nasal polyps.~   "
166518|NCT01386112|"~     Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by~     eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological~     treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by~     published case series and controlled trials in children and adults, the most widely used drug~     treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal)~     action.~      This study will evaluate the safety and tolerability of orally administered EUR-1100 once or~     twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The~     Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening~     visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom~     assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.~   "
166519|NCT01386099|"~     The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of~     PSN821 in patients with type 2 diabetes.~      Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the~     start of treatment and at the end of a 12 week treatment period as the primary endpoint.~     HbA1c, fasting plasma glucose and body weight are secondary endpoints.~   "
166520|NCT01386086|"~     Currently there are no controlled data on the management of postpartum depression that fails~     to respond to adequate antidepressant therapy. The investigators recently reported that a~     large number of patients responded to the addition of atypical neuroleptics after having~     failed antidepressant trials. Aripiprazole used adjunctively to antidepressants is effective~     in patients with resistant depression but it has not been studied in patients with resistant~     postpartum depression. The investigators propose to conduct a 6 week open-label study to~     assess the effectiveness and tolerability of aripiprazole used adjunctively to~     antidepressants in patients with resistant postpartum depression.~   "
166521|NCT01386073|"~     The purpose of this study is to compare the efficacy of FreshKote and Systane for the~     reduction of dry eye signs and symptoms.~   "
166522|NCT01386060|"~     The study purpose is to evaluate efficacy of a mindfulness training intervention and learn~     about cognitive and physiological markers of stress.~   "
166623|NCT01384734|"~     The purpose of this study is to assess the safety, efficacy, tolerability and~     pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil~     Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well~     tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1~     infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.~   "
166528|NCT01385982|"~     Clinically significant test results require timely clinician follow-up including the~     non-urgent clinically significant, or actionable, test results that have received less~     standardized management and attention. Unfortunately, failure to correctly manage actionable~     test results is not infrequent and may be associated with important delays in diagnosis and~     treatment and patient harm. The investigators have designed a safe practice intervention to~     improve the management of actionable test results for ambulatory patients in a large~     healthcare system.~   "
166529|NCT01385969|"~     The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs and~     allowing them to recoil will put the pressure of the LMA cuff within the safety range. It~     will also determine if remaining within this safety range has an effect on complications~     after surgery..~   "
166530|NCT01385956|"~     The goal of this clinical research study is to learn if the study drug SOM 230 in addition to~     standard therapy of gemcitabine can shrink or slow the growth of pancreatic cancer. The~     safety and tolerability of different doses of SOM 230 will also be studied. The participants'~     physical state, changes in the size of the tumor, and laboratory findings taken while~     on-study will help us (the study doctor and Moffitt Cancer Center) decide if SOM 230 is safe~     and effective.~   "
166531|NCT01385943|"~     The goal of this study is to test a protocol that uses clinical pictures, confocal~     reflectance microscopy images and dermoscopic information in a telemedicine platform. This~     protocol will test the technologies and diagnostic performance of dermoscopy and confocal~     reflectance microscopy in a randomized prospective multicenter study in five different~     centers in Europe.~   "
166532|NCT01385930|"~     The aim of the study is to evaluate self-reported adherence to and the effects of an~     intervention model consisting of individualized prescribed dietary advice (DAP) in~     combination with Motivational Interviewing (MI), social support and mobile services in obese~     patients in primary health care. The specific aim is to relate effects of the intervention~     model to self-reported health, biomarkers for coronary heart disease, diabetes, some cancer~     forms, sleep duration and quality, health economy, oral health, dietary intake and physical~     activity.~      This is a two-armed randomized controlled study. The arms are: 1) Control group (care as~     usual) and 2) Experimental group (MoR). The volunteers will be consecutively, for each sex,~     randomized to the experimental and the control group, respectively.~      The experimental group will receive DAP together with Motivational interviewing up to six~     months after the start of the study. From six months up to 24 months the participants will~     receive social support online and mobile services.~      The control group will receive dietary information according to the Habo model. The~     previously mentioned diet will be recommended to both the control group and the experimental~     group since it is the method in which the investigators give the information they want to~     study and not the diet per se. Thus, it is only the way the investigators give dietary~     information that differs between the groups.~      The study also includes qualitative interviews. The aim of these studies is to gain~     understanding of patients' and health professionals' experience and attitudes around food,~     lifestyle and support functions associated with dietary change. The sampling approach~     involves the purposeful selection of cases with a wide range of variation, which means that~     the researcher selects people who are able to provide rich information about the current~     issue. To achieve diversity, it is useful that both women and men are involved in the~     studies, as well as people of different ages and with different experiences of providing or~     receiving dietary advice. About 15-20 people will participate in each interview study.~   "
166533|NCT01385917|"~     PreU7-53 is a natural history study. The objective is to monitor the clinical and~     radiological course of upper limb muscle impairment in patients with Duchenne Muscular~     Dystrophy (DMD), potentially treatable with AAV-mediated exon 53 skipping.~   "
166534|NCT01385904|"~     The purpose of this research study is to measure how much, if any, ketamine is absorbed into~     the blood stream after ketamine gel is applied to the skin. The investigators expect that the~     topical administration will provide pain relief locally, at the site of pain, but not be~     absorbed into the bloodstream and thus not cause side effects. This research will help assess~     the safety of this drug by measuring the blood concentrations of the drug.~      Ketamine is a general anesthetic drug but also has excellent pain relieving qualities. It has~     been used to relieve chronic pain by administering intravenously, by mouth, or as an~     injection beneath the skin. When given these ways ketamine can occasionally cause side~     effects like dizziness, nausea, nightmares, agitation, hallucinations. Recently it has been~     used topically for patients with neuropathic pain in order to avoid the dizziness and nausea~     side effects.~      Neuropathic Pain can be partially caused by the misfiring of small nerve fibers close to the~     area of pain. By applying it on the skin, it is expected the drug can penetrate the skin and~     act directly on the small nerve fibers. The advantage is that less drug will get into the~     blood circulation. Up to now, it has not been carefully studied how much of the drug appears~     in the circulation after application on the skin.~   "
166535|NCT01385891|"~     Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able~     to induce remission in resistant/refractory acute leukemias in pediatric.~      Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute~     Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40~     mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day)~     in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet~     recovery (CRp) and toxicity~   "
166536|NCT01385878|"~     Cataract surgical techniques have significantly changed in recent years with the widespread~     adoption of smaller and smaller clear corneal incisions for phacoemulsification.~     Microincision surgery has many advantages, including reduced surgically induced astigmatism,~     faster visual recovery, and reduced intra and postoperative inflammation. Curently,~     microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions.~     However, there is still a debate as to which is the best absolute incision size for~     microcoaxial cataract surgery.~      The aim of this study is to evaluate incision stability following microcoaxial~     phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare~     intraoperative performance and postoperative outcomes following microcoaxial~     phacoemulsification performed through these two incision sizes.~   "
166537|NCT01385865|"~     The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose~     in subjects with impaired fasting glucose.~   "
166571|NCT01385410|"~     This behavioural support intervention trial will investigate the potential to increase~     exclusive breastfeeding rates in an urban Kenyan community through peer mother support~     delivered either by cell phone or through group meetings. It will follow a cohort of more~     than 800 women attending antenatal care at a large public hospital, and compare indicators of~     breastfeeding and infant and maternal health between groups receiving one or other type of~     peer mother support. The main part of the study will test the primary hypothesis that peer~     group and cell phone based support can both increase rates of EBF at 3 months by 20% relative~     to a control group.~   "
166572|NCT01385397|"~     Obesity is an important public health problem that is taking epidemic proportions worldwide.~     Indeed, nearly 50% of Canadians are obese and their number has increased dramatically in the~     last 20 years. Direct costs of obesity added to those of sedentary represent nearly 5% of the~     health system's budget. Also, obesity is linked with multiple co-morbidities; furthermore,~     modest weight loss has significant impact on type 2 diabetes, blood pressure and even reduces~     mortality. The investigators group has implemented an interdisciplinary team that has~     demonstrated its effectiveness for obesity management. However, the majority of obese~     subjects should be treated by primary care physicians (PCPs) that often feel uncomfortable~     when faced with the management of obesity. The investigators have therefore developed a~     clinical preceptorship for PCPs; this continuing medical education (CME) activity aims at~     engaging PCPs in obesity/overweight management. The current research proposal is aimed at the~     development and implementation of an innovative, integrated, interdisciplinary obesity care~     management system involving both primary and secondary health care professionals.~      The investigators hypothesize that CME based on preceptorships in combination with electronic~     tools (web site and virtual community), networking primary care (FMGs) and secondary care~     health professionals, will increase the knowledge, modify attitudes and perceptions of health~     care professionals and increase their sense of self-efficacy. Furthermore, this intervention~     should modify health care organization regarding obesity management and eventually improve~     accessibility to optimal obesity care.~      The investigators will use both action (objectives 1-2) and evaluative (objectives 3-5)~     research in order to attain specific objectives: 1) Develop and implement a~     preceptorship-based CME complemented by a web site for physicians and nurses working in~     Family Medicine Groups (FMGs). This CME will be based on needs assessment and will be~     validated by one FMG using questionnaires and semi structured interviews. Also, references~     and teaching tools will be available for participants on the web site. 2) Establish a~     collaborative intra/inter-regional interdisciplinary network to enable on-going expertise~     update and networking for FMG teams. This tool consists of a discussion forum including~     exchanges about difficult cases and a monthly virtual meeting of all participants. 3)~     Evaluate the implementation of this integrated system at the level of the ability to form a~     number of 8 FMGs/year, access and utilization of the electronic tools and participants'~     satisfaction (physicians, nurses and experts). This will be measured with the help of~     questionnaires and web logging tools. Questionnaires and group interviews will also be~     performed in order to evaluate participants' satisfaction. 4) Determine the impact for the~     participants at the level of knowledge and expertise, attitudes and perceptions, and~     self-efficacy regarding the management of obesity. Questionnaires and interviews will be used~     to this purpose. 5) Deliver transferable knowledge for health professionals and~     decision-makers. Strategies and pitfalls of setting up this program will be identified,~     performance indicators series will be developed and accessibility to care will be evaluated~     for each FMG and the 2nd line team. A knowledge transfer plan will be elaborated and applied.~   "
166538|NCT01385852|"~     Understanding and modulating fluid parameters is an important, but often overlooked aspect of~     phacoemulsification. In a previous study we compared the impact of using high fluid~     parameters versus low fluidic parameters on real-time IOP measured during~     phacoemulsification. The investigators found that using high parameters resulted in a higher~     absolute rise in IOP as well as higher fluctuations in the IOP when compared to low~     parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber~     instability. Based on the results of this study, the investigators decided to take it further~     and study the impact of using high parameters (and thus, higher chamber instability) on~     macular edema and thickness following surgery, in an otherwise uncomplicated surgery.~      Higher fluid parameters during phacoemulsification predisposes the eye to increased macular~     thickness~   "
166539|NCT01385839|"~     The purpose of this study is to look at the safety, as well as the efficacy of hair~     transplantation compared with irritation with hypodermic needles in the treatment of subjects~     with refractory alopecia areata.~      With this study, the investigators hope to demonstrate that trauma is just as effective as~     hair transplant in the treatment of recalcitrant alopecia areata of the scalp.~   "
166540|NCT01385826|"~     The investigators propose to study the efficacy of adalimumab versus placebo (double-blind~     randomization on inclusion into 2 equal groups) on reduction of ocular inflammation~     quantified by laser flare photometry after two months of treatment in patients with active~     uveitis despite well conducted treatment with steroid eye drops and MTX. The primary~     objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus~     the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2~     months after inclusion, presents at least 30% reduction of inflammation on laser flare~     photometry and improvement or a stable appearance on slit lamp examination. After the second~     month, all patients wishing to continue the trial and presenting a satisfactory clinical~     state will be treated with adalimumab for a total of one year after inclusion to~     descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.~   "
166541|NCT01385813|"~     This is an investigation of inflammatory markers in women destined to develop preeclampsia.~   "
166542|NCT01385800|"~     Grass pollen allergens are recognised as a major cause of allergic diseases in humans and~     animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen~     allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass~     pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising~     vaccine, currently being developed for the treatment of grass allergy.~      This study will look at the efficacy, safety and tolerability of three doses of ToleroMune~     Grass in grass allergic subjects following challenge with with grass in an Environmental~     Exposure Unit (EEU).~   "
166543|NCT01385787|"~     This is a non-therapeutic study. Pediatric AML patients undergoing HCT with a myeloablative~     preparative regimen may be enrolled. Subjects can be enrolled 10-40 days prior to HCT. Three~     samples for MRD (measured by WT1 PCR and flow cytometry) will be collected from peripheral~     blood and bone marrow: 1) pre-HCT (<3 weeks prior to starting the preparative regimen), 2)~     day 42 +/- 14 days post HCT (early post-engraftment), and 3) day 100 (+/-20 days) post HCT.~     For two years after transplant, the subject's follow-up data will be collected using the~     Research Level Forms in the CIBMTR Forms Net internet data entry system. The main objective~     is to determine whether there is any association between level of pre-transplant and~     post-transplant bone marrow MRD using WT1 and flow cytometry with 2-year event-free-survival,~     and to estimate the strength of that association in terms of the predictive accuracy of MRD.~     The investigators hypothesize that measurable MRD at either time point will be associated~     with decreased 2-year event-free survival.~   "
166544|NCT01385774|"~     The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of~     two treatment strategies of Intermittent Claudication (IC) due to an iliac artery~     obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous~     Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA.~      It is our hypothesis that PTA as first line treatment is more effective than SET as first~     line treatment with regard to maximum walking distance, quality of life and costs after one~     year.~   "
166545|NCT01385761|"~     The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the~     current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.~   "
166546|NCT01385748|"~     The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to~     treat chemoradiation therapy induced severe oral mucositis in patients with head and neck~     cancer.~   "
166547|NCT01385735|"~     The current study aims to assess the effect of an 8 week Azilect treatment (as adjunct~     therapy to levodopa) on affect perception and emotional expressiveness in a double-blind~     placebo-controlled study.~   "
166548|NCT01385722|"~     A research study to learn about the biologic features of cancer development, growth, and~     spread. We are studying components of blood, tumor tissue, normal tissue, and other fluids,~     such as urine, cerebrospinal fluid, abdominal or chest fluid in patients with cancer. Our~     analyses of blood, tissue, and/or fluids may lead to improved diagnosis and treatment of~     cancer by the identification of markers that predict clinical outcome, markers that predict~     response to specific therapies, and the identification of targets for new therapies.~   "
166549|NCT01385709|"~     The aim of this study is to determine whether blood levels of lithium or sertraline are~     affected by different phases of the menstrual cycle and whether there is an effect on~     psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and~     one visit during the follicular phase of the menstrual cycle. On each visit, they will fill~     out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will~     be drawn to measure progesterone level and either a lithium or sertraline level, depending on~     which medication the patient takes. The primary hypothesis in this study is that blood levels~     of lithium and sertraline will be significantly lower in women during the luteal phase of the~     menstrual cycle than during the follicular phase. Examination will also be made of whether~     symptoms will increase in severity during the luteal phase as compared to the follicular~     phase. The investigators expect a negative linear association between symptom severity and~     blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline~     decrease.~   "
166550|NCT01385696|"~     Preference study: Genuair vs HandiHaler inhalers in COPD patients.~   "
166551|NCT01385683|"~     Dabigatran (Pradaxa ®) is a new oral anticoagulant. It is used to prevent venous~     thromboembolism in orthopedic surgery and has recently demonstrated efficacy and safety at~     least as good as anticoagulants in the prevention of thromboembolism in atrial fibrillation~     and the treatment of venous thromboembolism. It is administered with fixed dose and does not~     require laboratory monitoring because of the low inter and intra individual pharmacokinetic~     (PK) and pharmacodynamics (PD) of dabigatran. However, the bioavailability of dabigatran is~     very low (6.5%) and is controlled by an efflux protein, P-GP. This molecule has a genetic~     polymorphism. The inhibition of this protein can cause a significant increase in intestinal~     absorption of dabigatran and expose patients to a risk of bleeding by overdose. Two major~     drug interactions have been identified : quinidine (cons-indication) and amiodarone~     (precautions). It is likely that other interactions exist and can be clinically significant~     in patients not selected such as testing. The development of tools to study the influence of~     P-GP on the PK and PD of dabigatran is therefore interesting. As the P-GP has a genetic~     polymorphism, the study of the latter is an important element in the detection of drug~     interactions. In this sense, clarithromycin, a potent inhibitor of P-GP is a good model to~     evaluate the primary mechanism of drug interaction of dabigatran and optimize the~     experimental design of studies to be conducted.~   "
166552|NCT01385670|"~     The objective of this study is to determine the safety, performance, and effectiveness of the~     SeptRx IPO PFO Closure System in the treatment of Patent Foramen Ovale (PFO) in patients who~     are amenable to percutaneous closure of their PFO defects.~   "
166553|NCT01385657|"~     The purpose of this study is to assess the safety and tolerability of repeated subcutaneous~     (SC) doses of REGN668 in patients with moderate-to-severe atopic dermatitis (AD).~   "
166554|NCT01385644|"~     The primary objective of this study is to establish the feasibility and safety of infusions~     of placental Mesenchymal Stem Cells (MSC) from related or unrelated HLA identical or HLA~     mismatched donors in the treatment of Idiopathic Pulmonary Fibrosis (IPF).~      The secondary objectives are to document changes in lung function, 6 minute walk distance~     (6MWD), gas exchange and radiological appearance following infusion of MSC over a six month~     evaluation period.~   "
166555|NCT01385631|"~     The purpose of the study is to examine the effect of the cholesterol lowering agent Ezetimibe~     when used in addition to optimal treatment with Atorvastatin in patients with acute~     ST-Elevation Myocardial Infarction (STEMI) who have not been in prior statin therapy.~      An area with arteriosclerosis not demanding intervention in a coronary vessel other than the~     infarct related is used as measuring point and is examined at time of the infarction and~     after 12 month using intravascular ultrasound and optical coherence tomography. At the same~     time the same techniques are used to examine the implanted stent.~   "
166556|NCT01385618|"~     Estradiol is synthesized by granulosa cells of ovaries under control of follicle-stimulating~     hormone (FSH) and luteinizing hormone (LH). It is known that Estradiol plays a crucial role~     in maturation and fertilization of oocytes. Furthermore it is involved in development of~     secondary female sexual organs, fertility and maintenance of pregnancy.~      Estradiol influences these processes by binding to estradiol receptors (ER). They are~     ligand-depending transcription-factors. In humans there are two subtypes: ERa and ERb, which~     are synthetized from gene ESR1 on chromosome 6 and ESR2 on chromosome 14. Both subtypes are~     expressed in the ovary. Both genes are polymorph. Especially for ERa subtype several~     polymorphisms and mutations are known which can be linked to breast cancer, spontaneous~     abortions, osteoporosis and the point in time of menarche. Furthermore some studies have~     shown a relationship between certain polymorphisms and the risk of infertility associated~     gynecological malfunctions and the result of IVF treatments.~      Progesterone is a hormone which plays a crucial role in initiation and maintenance of~     pregnancy. It induces the transformation of the endometrium, which facilitates the~     implantation of the fertilized oocyte and supports the pregnancy. Progesterone acts by~     binding to its receptor. The gene for this receptor is polymorph within the population,~     whereas some variants seem to account for implantation failure of embryos.~      In the investigators study the investigators will analyse the role of ERP and PRP~     polymorphisms in the context of IVF treatment. The analyzed genotypes are two polymorphisms~     of ESRI, called Pvu and Xba, as well as a variant of ESRII, ER2. In the progesterone receptor~     gene a single nucleotide exchange at position +331 (G->A) plays a role.~      The parameters correlated with are concentrations of estradiol, progesterone and FSH, number~     of follicles, number of fertilized oocytes and pregnancy rate.~      The investigators hope to optimize established treatment protocols and to improve the chances~     of success of IVF treatments depending on the genotype of the patient.~   "
166557|NCT01385605|"~     Environmental pollutants might be jointly responsible for increase of infertility among~     women. Especially endocrin active substances seem to be of particular importance. These~     substances are chemicals which interfere with the physiological system of humans and animals.~     They have a negative impact on the endocrine system and disturb the functions of organs whose~     hormones regulate the male and female reproductive system.~      It is known that exposition to these chemicals lead to subfertility, infertility, raised~     abortions, birth defects and ovarian malfunction.~      Additionally it was shown that human embryos have a decreased cleavage rate after IVF when~     developing from oocytes with elevated concentrations of environmental pollutants.~      In this study the main focus concentrates on Nonylphenols (NP). Follicular fluids of women~     with subfertility will be analyzed by a newly developed principle including HPLC and~     NMR-Spectroscopy. This enables quantitative and qualitative analysis of enantiomers of NP.~      The results will allow risk estimations for several endocrine active substances, especially~     NP.~      Additionally conclusions concerning the correlation between thes substances and subfertility~     can be drawn.~   "
166558|NCT01385592|"~     This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's~     Disease L-dopa Induced Dyskinesias (PD-LID)~   "
166559|NCT01385579|"~     The purpose of this study is to determine if the direct mailing of fecal occult blood testing~     (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to~     improve colorectal cancer screening rates within a low income and racially/ethnically diverse~     population.~   "
166560|NCT01385566|"~     This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both~     intradermally and subcutaneously at various doses.~   "
166573|NCT01385384|"~     Permanent dependency of breathing apparatus due to spinal cord injury is traditionally~     treated with different types of mechanical ventilation. However, the electric ventilation~     became a possibility through their most current versions, such as diaphragmatic pacemakers.~      Diaphragmatic pacemakers rhythmically stimulates the diaphragm to replace the functions of~     the respiratory center that doesn't works well or is inaccessible. However, this modality has~     the prerequisite that the phrenic nerve and diaphragm muscle are normal. The reason for the~     development of diaphragmatic pacemaker freeing the patient from the ventilator.~      By using the mechanical energy of the diaphragm of the patient, the patient may come not need~     the ventilator tubing, tracheostomy, and with the help of their caregivers, the inconvenient~     mechanical ventilators.~   "
166561|NCT01385553|"~     Social service systems rarely acknowledge the status of men as fathers in the~     conceptualization and delivery of treatment for substance abuse or domestic violence.~     Although there has been extensive focus on the treatment of mothers who abuse substances, are~     victims of intimate partner violence (IPV) (defined as physical aggression and/or~     psychological abuse and control at the hands of an intimate partner), or maltreat their~     children there has been little consideration of the need for interventions for fathers with~     histories of co-morbid IPV and substance abuse. It is estimated that between 10 and 17.8~     million children are witness to violence in their homes each year. National and regional~     samples indicate 50-70% of families impacted by IPV and the typically co-occurring substance~     abuse have children under the age of seven. Large percentages of these men continue to live~     with or have consistent contact with their young children despite aggression and substance~     use.~      Court mandated treatments for perpetrators of domestic violence have become the norm, however~     the efficacy of these treatments is questionable and most do not speak to the broader needs~     of batterers and their families. How batterer's treatments might impact parenting and~     father-child relationships and the psychosocial functioning of children is vastly~     understudied and not currently understood. Since batterer treatments are court mandated and~     require tremendous financial and community resources, the efficacy of these interventions in~     stopping the cycle of domestic violence and improving the health and well-being of the~     batterer, his partner and children is crucial. There are currently NO evidence-based~     treatments that address co-morbid substance abuse and domestic violence perpetration with~     emphasis on paternal parenting and the father-child relationship. Consequently, the proposed~     psychotherapy development project will develop and evaluate the potential efficacy of a~     novel, relational parent intervention for fathers with co-morbid substance abuse and IPV who~     have young children. The goals of this intervention are to decrease aggression and substance~     abuse by increasing focus on fathering and an improved father-child relationship.~   "
166562|NCT01385540|"~     This will be an experimental task-based functional MRI pilot study involving the neuroimaging~     assessment of patients with severely bothersome tinnitus, defined by a global bothersome~     scale. The investigators plan to enroll a total of 12 participants (6 severely bothered~     tinnitus and 6 age-matched non-tinnitus controls) over the course of six months to undergo~     task-based imaging. Subjects in the tinnitus group may have previously participated in the~     CTRWU study (HRPO: 07-0689) conducted by Dr. Jay Piccirillo at Washington University and have~     given permission to be contacted for consideration in future studies. The selected paradigm~     will allow us to advance knowledge about the role of the attention, control, and other~     cortical networks in the development and maintenance of bothersome tinnitus.~   "
166563|NCT01385527|"~     The purpose of this study is to evaluate whether participation in an Internet-based~     intervention helps improve atopic dermatitis treatment outcomes.~   "
166564|NCT01385514|"~     The purpose of this study is to evaluate strategies to prevent Staphylococcus aureus skin and~     soft tissue infections in soldiers during infantry training.~      This study will be conducted on three different bases among groups of male recruits to IDF~     training base. They will provide nasal swabs to detect Staphylococcus aureus carriage in two~     time points: 1. before mixing and training in confined settings, reflecting carriage acquired~     before entering 2. After 14-30 days. All soldiers will be under surveillance for skin~     infection until the end of the training program.~   "
166565|NCT01385501|"~     This research project will develop an educational intervention to improve immunization~     acceptance by vaccine hesitant parents. This is prospective interventional case-control~     trial, where the investigators will provide the intervention in the clinical setting.~     Enrollees will be screened and selected if they meet criteria for vaccine hesitancy. The~     investigators will conduct follow up surveys following the intervention to assess change in~     attitude and follow immunization rates through 18 month well visit.~   "
166566|NCT01385488|"~     -  Breast cancer treatment-related lymphedema requires life-long self-care is required.~        -  No objective measurement mechanism exists that can easily be used to self-monitor arm~          volume.~        -  Bioelectrical impedance devices approved for lymphedema measurement may be able to be~          used for self-monitoring.~        -  The investigators will conduct a two-part study to first develop an impedance driven~          self-measurement protocal and then test the protocol in home settings.~        -  The investigators hypothesize in part two of the study that when compared to~          participants who are not self-monitoring, those who self-monitor limb volume will: 1)~          report more days of garment use, skin care, and simple-MLD; and, 2) have fewer, less~          distressful, less intense symptoms, better productivity/activity, report higher~          perceived self-management/self-efficacy and QOL; experience fewer missed days of work,~          lymphedema treatment days, arm infections, and have a smaller number of antibiotic~          prescriptions.~   "
166567|NCT01385475|"~     The primary purpose of this study is to examine the effectiveness of the current resistance~     training guidelines for older adults proposed by ACSM/AHA to improve physical function in~     individuals with reduced physical abilities. A randomized controlled intervention trial will~     be used to compare change in physical function pre- and post-intervention between a treatment~     group receiving the minimum recommendations of the guidelines and a control group asked not~     to change their physical activity participation. To better understand the clinical~     significance of such an occurrence, a secondary purpose was to determine if older adults with~     reduced physical abilities who adhere to the recommended intervention dosage will experience~     a change such that they can be reclassified to a more favorable level of functioning. It is~     hypothesized that the minimum recommended dosage of the guidelines would be sufficient to~     both improve physical function and improve functional classification in older adults with~     reduced physical abilities.~   "
166568|NCT01385449|"~     The primary hypothesis is that those patients who choose an interscalene catheter will have~     less pain postoperatively than those with single injection blocks. Secondary hypotheses~     examine physical therapy outcomes and incidence of parasthesia or pain following surgery for~     up to 3 months.~   "
166569|NCT01385436|"~     Human papillomavirus (HPV) of high-risk genotype is a necessary risk factor in development of~     cervical cancer. There is a vaccine available to prevent cervical lesions associated with~     high-risk HPV genotypes 16 and 18. In Croatia HPV vaccination has not yet been introduced in~     obligatory vaccination schedule. The aim of this study is to describe the pre-vaccination~     distribution of HPV genotypes in women with high grade cervical squamous intraepithelial~     lesion (HSIL) and cervical cancer in Croatia. The investigators hypothesis is that HPV-16 is~     the most frequently found genotype but the distribution of other HPV genotypes is~     heterogeneous and includes genotypes currently not covered by vaccination.~   "
166570|NCT01385423|"~     This is a single center, modified standard design dose escalation study designed to~     determine the maximum tolerated, minimum efficacious dose (MTD/MED) of IL-15 (Intravenous~     Recombinant Human IL-15) and incidence of donor natural killer (NK) cell expansion by day +14~     when given after haploidentical donor NK cells in patients with relapse or refractory acute~     myelogenous leukemia (AML).~   "
166703|NCT01383694|"~     Piperine acts on the oropharyngeal TRPV1, increasing sensory input and the release of~     substance P. These actions may accelerate the oropharyngeal swallow response, improving the~     swallowing of dysphagic patients.~   "
166574|NCT01385371|"~     This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243)~     versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms.~     Participants will receive either the sublingual grass tablet or a placebo tablet during the~     study. It is expected that those participants receiving the active sublingual grass tablet~     will have less hayfever symptoms and need less medications to treat hayfever symptoms during~     the grass pollen season.~   "
166575|NCT01385358|"~     Atrial fibrillation(AF)is the commonest arrhythmia worldwide and can lead to significant~     morbidity and mortality, posing an increasing public health burden. Restoration of sinus~     rhythm (SR) is the preferred strategy in symptomatic patients but outcomes with~     anti-arrhythmic drugs (AAD) are poor. The alternatives to AAD are two-fold.Firstly, catheter~     ablation (CA)- a technique that uses catheters (thin tubes) to deliver small 'heat lesions'~     to areas of the heart to eliminate AF. Secondly, surgical ablation, where multiple incisions~     are made in the atria to restore SR. Long term results from this traditional surgical~     approach are excellent however as it is technically difficult open-heart procedure with~     significant morbidity and mortality, it is seldom used.~      CA is very effective in restoring SR in the early stages of AF when it is a paroxysmal~     (intermittent) rhythm disturbance. If not treated at this stage AF inevitably evolves into a~     more persistent or permanent state and becomes more difficult to treat with CA. Therefore,~     the optimum approach to treat patients with symptomatic long standing persistent AF has yet~     to be determined and remains a key area of on-going research.~      New minimally invasive, thoracoscopically assisted surgical(closed-heart)approaches have~     recently developed which ablate a wide area around the pulmonary veins, and may offer~     advantages over the best current strategies in CA. There are also clear advantages for~     patients with greater safety and less discomfort when compared to traditional surgical~     open-heart procedures.~      At present there is small amount of encouraging data on this thoracoscopic surgical technique~     but there is no data comparing these two modalities of treatment in persistent AF patients.~     The investigators therefore wish to prospectively investigate the safety and efficacy of this~     thoracoscopic surgical technique and compare with CA in this group of patients. MRI scanning~     will also be used to visualise the effects of ablation by analysis of scar formation.~      The study hypothesises that thoracoscopics surgical ablation is a~   "
166576|NCT01385345|"~     This study will test the hypothesis that 6 months of periodic high dose Vitamin D3~     replacement (200,000 and 100,000 units cholecalciferol, oral liquid drops at 6 to 8 week~     intervals) followed in-between by daily 1000 units, decreases insulin resistance by HOMA2-IR~     ≥ 0.36, in comparison to control, standard dose Vitamin D3 1000IU/ day for 6 months, in south~     Asians with both Vitamin D deficiency (defined as 25 Hydroxy vitamin D < 25nmol/l) and~     insulin resistance (defined as HOMA1 -IR≥ 1.93).~      The hypothesis formed suggests that insulin resistance developed in South Asians is~     explained, at least in part, by the presence of Vitamin D Deficiency (VDD). Therefore if the~     VDD is reversed/ 'normalised into target range' using Vitamin D therapy in individuals at~     risk of diabetes, then markers of insulin resistance should reduce from baseline values.~     However, current UK recommended doses of Vitamin D do not adequately replenish severe VDD,~     common in South Asians, back into the target range and therefore will not reduce insulin~     resistance markers. Therefore only higher pharmacological doses are able to replace severe~     Vitamin D deficiency adequately and improve insulin resistance markers.~   "
166577|NCT01385332|"~     The purpose of this study is to determine the efficacy and safety of two new patterns of~     controlled ovarian hyperstimulation (defined as total number of picked up eggs). This study~     will be performed in egg donors but these new patterns will be implemented in fertility~     preservation patients.~   "
166578|NCT01385319|"~     To prospectively evaluate in a multicenter open label trial whether the use of~     zotarolimus-eluting ENDEAVOR Stent implantation in patients at low restenosis or at high~     bleeding or thrombotic risk will decrease the incidence of 12-month major adverse cardiac~     events (MACE) including overall death, any myocardial infarction (MI) or any target vessel~     revascularization (TVR).~   "
166579|NCT01385306|"~     The objective of this feasibility research study is to gather preliminary clinical data~     regarding the safety and potential clinical benefit of noninvasive neurostimulation of the~     vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to~     asthma.~   "
166580|NCT01385293|"~     The purpose of this study is to evaluate the effects of the study drug, BKM120. The study~     drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This~     protein is found in normal cells and in cancer cells, but often in many cancer cells this~     protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this~     has not been tested yet in men with prostate cancer.~   "
166581|NCT01385280|"~     RATIONALE: Estrogen can cause the growth of tumor cells. Hormone therapy using therapeutic~     estradiol may fight breast cancer by lowering the amount of estrogen the body makes. Though~     estradiol initially produces stimulation of ER+ cancer cells, both laboratory and some~     clinical experience indicate that it may have the opposite effect on such cells, once they~     have become resistant to estrogen deprivation. In laboratory models, there is death of the~     resistant population after estradiol treatment, followed by restoration of sensitivity of~     the remaining cells to estrogen deprivation, as with an aromatase inhibitor. Exemestane may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     therapeutic estradiol together with exemestane may kill more tumor cells.~      PURPOSE: This clinical trial studies therapeutic estradiol and exemestane in treating~     post-menopausal patients with hormone receptor-positive metastatic breast cancer~   "
166582|NCT01385267|"~     Objectives:~      To evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and~     body weight. If we find discordance in fetal lung maturity in twin gestations this will~     change current practice of sampling only one amniotic sac for evaluation of fetal lung~     maturity.~   "
166583|NCT01385254|"~     The proposed study will explore longitudinally the impact of a very low birthweight (VLBW)~     infant on mother-sibling interactions and sibling adjustment. The study will also include a~     comparison group of fullterm infants to determine which sibling adjustment problems are~     typical of having a new baby in the home and which are associated with the unique stress of~     having a VLBW infant. This study will be the initial step in identifying factors affecting~     the adjustment of siblings of VLBW infants.~   "
166584|NCT01385241|"~     The purpose of this study is to test the feasibility of a stigma reduction intervention in~     Human Immunodeficiency Virus(HIV)-positive women using a video of first-person narratives~     delivered via personal Ipod Touch.~   "
166585|NCT01385228|"~     The primary purpose is to define the safety and tolerability of docetaxel/prednisone in~     combination with pazopanib (DPP) in men with metastatic Castration Resistant Prostate Cancer~     (mCRPC).~   "
166704|NCT01383681|"~     This is a retrospective study of patients with spasticity in the Spanish population.~   "
166586|NCT01385215|"~     The purpose of this study is to determine the safety and effectiveness of the influenza~     vaccine when administered nasally and intra-muscular (a shot of medicine given into a~     muscle). The investigators will measure the systemic (through out the body) and mucosal~     immune responses (how your body recognizes and defends itself against bacteria) to nasally~     administered influenza vaccine, and determine if nasal immunization results in immunity (your~     body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral~     and reproductive), in comparison with intramuscular administration and placebo (inactive~     substance given in the same form as the active drug).~   "
166587|NCT01385202|"~     The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL®~     SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug~     refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology~     mapping and RF procedures.~   "
166588|NCT01385189|"~     This study is designed to evaluate the safety, reactogenicity, and immunogenicity of Na-GST-1~     adsorbed to Alhydrogel® with or without two different dose concentrations of a novel~     adjuvant, GLA-AF (1 µg or 5 μg) among healthy adult volunteers.~   "
166589|NCT01385176|"~     The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve~     stimulation in heart failure patients with a New York Heart Association Class III, an~     ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than~     130 ms.~   "
166590|NCT01385163|"~     The Democratic Republic of the Congo (DRC) has become synonymous with sexual violence by~     armed groups within the last 2 decades. Reportedly, tens of thousands of women and girls have~     been raped, sexually assaulted, attacked and abducted in the Eastern Provinces including~     North and South Kivu, targeted by armed groups with unparalleled levels of brutality.~      Access to services in North and South Kivu—both emergency and longer term care—remains a~     major challenge. Limited services as well as the potential stigma of seeking services mean~     that many survivors have never received adequate care. Results of a preliminary study found~     many survivors have substantially reduced ability to function, including reduced ability to~     perform basic tasks and activities related to earning, self care, caring for family, and~     contributing to their communities. These survivors also describe high rates of mental health~     and social problems including mood disorders, anxiety, withdrawal, and stigmatization and~     rejection by family and community.~      While social and economic development in conflict affected areas like DRC relies on~     populations who are ready and able to work, the psychological effects of conflict may mean~     that a percentage of the population living in these low-resource areas are less able to~     engage in economic opportunities even when they are available. However, there is little data~     on the best strategy to deal with this.~      This study will be run as two parallel randomized impact evaluations to investigate the~     impacts of two different intervention programs to be implemented as part of standard~     programming of the collaborating NGO. The first study will focus on the impact of IRC's~     social-economic intervention, Village Savings and Loans Associations (VSLA) compared to a~     wait-control sample. The VSLA impact evaluation study will be conducted in communities served~     by 9 community-based organization (CBO) partners. The second study will focus on the impact~     of a mental health intervention, Cognitive Processing Therapy (CPT) compared to a~     wait-control sample. The CPT impact evaluation study will be conducted in communities~     serviced by NGO partners currently providing psychosocial support. As an exploratory~     investigation, the researchers will follow the CPT program with the VSLA program to look at~     the effect of receiving a mental health intervention prior to the VSLA on rates of retention~     and impact.~   "
166591|NCT01385150|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors identify and lean more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in blood samples from patients with acute~     myeloid leukemia.~   "
166592|NCT01385137|"~     RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and~     bone pain and stiffness caused by hormone therapy in patients with breast cancer.~      PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in~     treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III~     breast cancer receiving hormone therapy.~   "
166593|NCT01385124|"~     Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing~     allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence~     of acute GVHD is estimated at 40-60% among patients receiving transplant from HLA-identical~     sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated~     transplants. More effective prevention and treatment strategies are needed.~      The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in~     animal models of various inflammatory diseases including multiple sclerosis, inflammatory~     bowel disease and rheumatoid arthritis.~      Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and~     immunosuppressive effects.~      As such, it may reduce the incidence and severity of GVHD after allogeneic stem cell~     transplantation.~   "
166594|NCT01385111|"~     This study aims to investigate a diagnostic yield and performance characteristics according~     to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA)~     and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration~     (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a~     better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in~     a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform~     EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first~     applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic~     yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the~     EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate~     diagnostic yields and performance characteristics of each group.~   "
166595|NCT01385098|"~     As the use of bariatric surgery for treatment of extreme obesity adults continues to rise,~     clinicians must be aware of pre-existing nutritional deficiencies in overweight and obese~     patients. Nutritional deficiencies are common in patients undergoing bariatric surgery and~     these deficiencies should be detected and addressed early to avoid post-operative~     complications. To improve long-term outcomes following bariatric surgery, nutritional~     screening and prescribing appropriate supplementation to prevent nutrient deficiencies is~     needed. Vitamin D deficiency is common following bariatric surgery and has been reported to~     occur in 50-80% bariatric patients.The goal of this pilot study is to help develop nutrient~     supplementation interventions following two types of bariatric surgery: Roux-en Y gastric~     bypass and sleeve gastrectomy.~      Recently, several studies in adults have revealed an inverse relationship between body fat~     and blood 25-hydroxyvitamin D3 [25(OH)D] levels, the relevant marker of low vitamin D status.~     Although vitamin D is well known for its essential role in bone metabolism and calcium~     homeostasis, increasing evidence is linking vitamin D to obesity. This study will evaluate~     vitamin D status during post operative daily supplementation of 2,000 IU of vitamin D3 and~     1500 mg of calcium through assessment of changes in serum 25(OH)D, parathyroid hormone (PTH),~     calcium and phosphorus at baseline, 4 weeks, and 12 weeks following surgery. The dietary~     contribution of vitamin D and calcium will be estimated by food records analyzed using the~     University of Minnesota 2010 Nutrition Data System for Research (NDSR) program.~      Primary Hypothesis: Daily supplementation with 2,000 IU of vitamin D3 for 12 weeks will~     significantly increase mean serum 25(OH)D levels in obese subjects following bariatric~     surgery compared to baseline levels.~      Secondary Hypothesis: The percent response above baseline to daily supplementation with 2,000~     IU of vitamin D3 will significantly differ between Roux-en Y and sleeve gastrectomy patients.~   "
166597|NCT01385072|"~     Patients with active acute leukemia have dismal prognoses even with allogeneic~     transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse~     rates are needed.~      Relapse risk after double umbilical cord transplantations have been shown to be significantly~     lower compared to matched sibling and matched unrelated donor transplantations due to better~     graft versus leukemia effect.~      The investigators hypothesize, that concomitant transplantation from 2 matched siblings may~     improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and~     other high risk hematological malignancies.~   "
166598|NCT01385059|"~     This randomized phase II trial studies how well axitinib works in treating patients with~     high-risk prostate cancer before undergoing surgery. Axitinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving axitinib before surgery~     may make the tumor smaller and reduce the amount of normal cells that have to be removed~   "
166599|NCT01385046|"~     Project FIT is a collaboration between the public school system, local health systems,~     physicians, neighborhood associations, businesses, faith-based leaders, community agencies~     and university researchers to develop a multi-faceted approach to promote physical activity~     and healthy eating toward the general goal of preventing and reducing childhood obesity among~     children in Grand Rapids, MI, USA. There are four overall components to Project FIT: school,~     community, social marketing, and school staff wellness - all that focus on: 1) increasing~     access to safe and affordable physical activity and nutrition education opportunities in the~     schools and surrounding neighborhoods; 2) improving the affordability and availability of~     nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge,~     self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school~     staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to~     incorporate healthful values; and 5) encouraging dialogue among all community partners to~     leverage existing programs and introduce new ones.~   "
166600|NCT01385033|"~     The purpose of this study is to evaluate radiolabeled [18F]MK-3328 as a PET tracer for~     estimating the regional distribution and extent of amyloid plaques in participants suffering~     from amnestic mild cognitive impairment (aMCI) and Alzheimer's Disease (AD) versus healthy~     young and elderly participants. The study hypotheses will test whether [18F]MK-3328 can~     discriminate between AD participants and cognitively normal elderly control participants as~     measured by brain regional tracer uptake.~   "
166601|NCT01385020|"~     Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a~     significant cholesterol lowering effect which might be caused by addictive and/or synergistic~     effects of lovastatin (monacolin K) with other monacolins and substances in capsules. The~     usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is one capsule~     twice/day.~      Gemfibrozil is a fibric acid derivative (fibrate). It can reduce the levels of triglycerides~     and increase the levels of high-density lipoprotein cholesterol (HDL-C). Patients with mixed~     lipid disorders may therefore benefit from a combination of a statin and a fibrate. Although~     the combination of a fibrate and a statin is highly effective,concerns about an increased~     incidence of myopathy and even rhabdomyolysis have limited the widespread use of such~     combinations. Such combination therapies are prone to drug-drug interactions, which can lead~     to altered pharmacokinetic profiles of either drug, an effect observed for many statins in~     combination with fibrates. However, the drug-drug interactions have not been reported between~     red yeast rice capsule and gemfibrozil.~      The objective of the study is to evaluate the effect of gemfibrozil on the plasma~     concentrations of lovastatin and its active form, lovastatin acid, from red yeast rice~     capsule in healthy volunteers. In addition, the investigators also measure the plasma~     concentration of creatine kinase (CK) and co-enzyme Q10 for safety assessment.~   "
166602|NCT01385007|"~     Aggression, a common symptom in persons with dementia, is linked with multiple treatable~     etiologies such as pain, depression, caregiver burden, and caregiver relationships. Pain, the~     main predictor of aggression, is a common symptom that is inadequately assessed and treated~     in persons with dementia. The main treatment for aggression is antipsychotic medications that~     are ineffective, costly, and possess considerable adverse side effects. There is a need to~     test psychosocial interventions that address treatable causes of aggression. Preliminary data~     suggest the potential utility of Preventing Aggression in Veterans with Dementia (PAVeD), an~     evidence-based psychoeducational intervention aimed to prevent aggression, with urban~     dwelling Veterans. PAVeD, an in-home intervention that requires significant clinician time~     and expense has yet to be evaluated in a rural culture with Veterans who are in poorer health~     compared to urban Veterans.~      The purpose of this intervention demonstration pilot study is to pilot test and evaluate the~     PAVeD-Telephone intervention. Twenty rural Veterans with dementia and pain and their~     caregivers from the Home Based Primary Care (HBPC) Program will be invited to participate.~     Clinical activities directed toward caregivers are supported by policies and procedures set~     forth by the Veterans Health Administration (Appendix A). Mixed-methods will be used to~     collect data using semi-structured interviews and standardized data collection measures~     suitable for persons with dementia and their caregivers. The interviews go beyond an~     evaluation of the outcomes by exploring how the intervention was experienced by the dyad.~      The specific aims of the study are to:~        1. Describe the feasibility and acceptability of the PAVeD-Telephone intervention (number~          of dyads recruited and completing the study) by rural Veterans and their caregivers.~        2. Describe the preliminary outcomes (aggression, depression, Veteran/caregiver~          relationship quality, pleasant events, caregiver burden, and pain) at baseline, 3 and 6~          months.~        3. Understand the cultural beliefs and practices of this population and the impact of the~          intervention.~      The PAVeD-Telephone intervention is an innovative approach to shift the paradigm of treating~     aggression with antipsychotic medications. This study is consistent with the goals of the~     South Central Mental Illness Research Education and Clinical Center (MIRECC) to improve~     evidence-based practices in rural Veterans and their caregivers. The next step in this~     program of research is to submit a Health Services Research and Development Service (HSR&D)~     application for pilot funding to further develop and test the telephone-based intervention~     and an appropriate control condition.~   "
166612|NCT01384877|"~     This study's primary objective is to test the hypothesis that a single infusion of~     subcutaneous lidocaine can cause a clinically useful reduction in cancer pain within 48 hours~     of infusion and lasting a minimum of 7 days. A clinically useful reduction in pain is defined~     by either a 2-point reduction (on a 0-10 scale) in the worst pain experienced over a 24-hour~     period, or a ≥30% reduction in 24-hour opioid requirement. We will use a composite endpoint~     of reduction in pain without increase in 24-hr opioid requirement or no decrease in pain with~     a ≥30% reduction in 24-hour opioid requirement.Subjects will receive either lidocaine or~     placebo, followed at least 1 week later by the alternate agent.~   "
166613|NCT01384864|"~     The overall objective of this pilot study is to determine whether multispectral imaging~     increases the diagnostic accuracy of the current standard of high-definition white-light~     endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or~     cancer). The investigators goal is to develop a multispectral endoscopic platform that can be~     used to survey a large surface area and, potentially, serve as a 'red flag' for~     microendoscopic imaging of small areas. The goal of this pilot study is to preliminarily~     determine the accuracy of these modalities during the endoscopic surveillance of Barrett's~     esophagus.~   "
166603|NCT01384994|"~     Up to 50% of patients with colorectal cancer (CRC) develop liver metastasis during the course~     of their disease. In 30-40% of patients metastasis is confined to the liver. In these~     patients R0-resection of metastases may contribute to marked improvement of overall survival.~     Primary resection of liver metastasis is possible in about 15-20% of patients (Scheele 2005,~     Petrelli 2005). Recent studies indicate that perioperative chemotherapy may improve survival~     after resection of liver metastases (Portier 2007, Nordlinger 2007). Nevertheless, there is~     evidence that 70-80% of patients have recurrent disease after resection of liver metastasis.~     Stratification for the risk of recurrence may be performed using the FONG-score (Fong 1999).~      This study is designed to investigate the efficacy of postoperative chemotherapy combined~     with an anti-EGFR treatment using panitumumab.~      The majority of patients present to the surgeon after chemotherapeutic pretreatment with~     various not necessarily standardized regimens. Also postoperative therapy after resection of~     liver metastasis is not a clearly defined standard of care in Germany.~      Based on the study by Nordlinger et al. an oxaliplatin-based regimen is chosen for~     postoperative therapy (Nordlinger 2008). For reasons of practicability mFOLFOX6 was selected~     as the chemotherapy backbone for additive treatment (Allegra 2010).~      Also, there is evidence that the combination of FOLFOX with panitumumab is associated with~     enhanced antitumor activity (Douillard et al. ESMO 2009). The experimental treatment arm will~     therefore evaluate the combination of FOLFOX plus panitumumab. Since in colorectal cancer~     monoclonal antibodies directed against the EGFR are not active in KRAS mutant patients, the~     experimental arm including panitumumab will only be performed in KRAS wild-type patients~     (Amado 2008).~      The planned study aims to assess the efficacy of postoperative therapy with FOLFOX plus~     panitumumab followed by maintenance with panitumumab for 3 months in KRAS wild-type patients,~     compared to the historical data for standard FOLFOX chemotherapy alone, which are verified by~     a randomised control group without the antibody. (Figure 1: Study Design).~      The study will allow preoperative treatment with regimens such as FOLFIRI, XELIRI, FOLFOX or~     XELOX +/-bevacizumab or +/- cetuximab. However, only those patients will be considered~     eligible who did not progress during preoperative therapy.~      After surgery, a treatment-free interval of at least 4 weeks, but no longer than 8 weeks will~     be granted.~      KRAS-wild-type patients (60% of all pts) will then be randomized in a 2:1 ratio to an~     experimental arm with FOLFOX + panitumumab or to a reference arm with FOLFOX alone.~     Combination treatment will be performed for a duration of 3 months, after which patients in~     the experimental arm will receive maintenance therapy with panitumumab for further 3 months.~     In the reference arm, treatment will, however, be ended after 3 months.~   "
166604|NCT01384981|"~     The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary~     rehabilitation increases exercise capacity and quality of life more than pulmonary~     rehabilitation alone.~   "
166605|NCT01384968|"~     Six days of dietary nitrate (NO3-) supplementation in the form of beetroot juice (~0.5 L•d-1;~     5.1-11.2 mmol NO3- •d-1) has been purported to reduce pulmonary oxygen uptake (VO2) during~     submaximal exercise and increase tolerance to high-intensity workloads. These results suggest~     that dietary nitrate supplementation has the potential to act as an ergogenic aid. Recently,~     we assessed submaximal oxygen uptake and 10 km time trial performance after 6 d of dietary~     nitrate supplementation in trained cyclists. We demonstrated an improvement in time trial~     performance compared to the nitrate-depleted placebo. However, the minimal dosage and~     duration of nitrate supplementation that is needed to elicit these performance effects remain~     largely unknown. Therefore, the purpose of the study is to assess performance capacity~     following an acute dose of nitrate supplementation consumed 3 h prior to the onset of~     exercise in trained cyclists. We will test the hypothesis that a single dose (140 mL; ~8 mmol~     NO3-) of dietary nitrate supplementation in the form of beetroot juice, ingested 3 h prior to~     exercise will improve time trial performance in trained cyclists compared to a~     nitrate-depleted placebo.~   "
166606|NCT01384955|"~     We attempt to investigate the influence of physiotherapy and physical activity education~     applied in adolescence on physical fitness, curve progression, pulmonary function, physical~     activity and quality of life in adulthood. Quality of life assessment includes mental and~     social functioning, body image, self - esteem, depression and anxiety surveillance. The~     follow - up period ranges from 15 to 26 years. Also a group of shorter follow - up of 9 - 13~     years is available.~      The null hypothesis is that scoliosis specific exercise program applied in adolescence does~     not influence HRQoL and functioning in adulthood.~   "
166607|NCT01384942|"~     Given that individuals in bereavement tend to experience substantial psychological distress~     in the first two years following loss, individuals seeking psychological support will need~     appropriate services grounded in sound empirical scholarship. There is a lack of studies~     assessing bereavement groups, despite groups being one of the most common forms by which such~     services are offered. The prominent and emerging process of meaning-reconstruction in~     bereavement research is theorized to lead to better psychological adjustment and prevent more~     prolonged grief reactions. The principal objective of this study is to compare two types of~     group counseling for individuals in bereavement: A novel meaning-based bereavement counseling~     group and a conventional bereavement support group.~   "
166608|NCT01384929|"~     There is scant data on the casemix and practices in Indian intensive care units (ICUs). Most~     of the available data comes from single centre studies. There is a dire need to have data~     from Indian ICUs to reflect the vast spectrum of critical care illness, services and~     practices. INDICAPS planned to collect data of all patients in the ICU on one particular day,~     and four such days spread throughout a one-year period were selected: the second Wednesday of~     July and October this year, i.e. July 14 and October 13, 2010 and the second Wednesday of~     January and April next year, i.e. January 12 and April 13, 2011. As many ICUs all over the~     country as possible were asked to participate. The investigators aimed to gather information~     about ICUs, patients in ICUs, the types and severity of illness, monitoring and therapeutic~     modalities used, types of infections,mortality rates, etc.~   "
166609|NCT01384916|"~     The purpose of the study is to investigate whether yoga or a health education group alleviate~     depressive symptoms for an individual with a partial response to antidepressant medication.~   "
166610|NCT01384903|"~     The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to~     plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative~     method in patients with Disseminated Intravascular Coagulation (DIC) associated with~     infection.~   "
166611|NCT01384890|"~     This will be a prospective longitudinal study describing clinical throughput metrics and~     patient reported quality of life outcome measures for patients undergoing Volumetric~     modulated arc therapy (VMAT) with and without Cone-beam computed tomography (CBCT) for head~     and neck carcinoma at the British Columbia Cancer Agency.~        1. VMAT for the treatment of patients with HNC will provide opportunities for image-guided~          radiotherapy using CBCT online correction to reduce systematic and random error.~        2. Analysis of patient reported quality of life outcomes during VMAT, with and without CBCT~          acquisition, will be hypothesis generating.~   "
166614|NCT01384851|"~     The purpose of this study is to determine the therapeutic effect of the chronic application~     of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition~     of environmental stress. The effect will be studied in terms of changes in tear physiology~     and the inflammatory biomarkers on the ocular surface.~   "
169284|NCT01349777|"~     This study is an open label, multi-center, randomized trial, which is designed to evaluate~     the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in~     patients undergoing PCI compared to conventional clopidogrel (Plavix®).~   "
166615|NCT01384838|"~     This randomized trial aims to assess if a well defined subgroup of breast cancer patients~     benefit from a controlled physical activity program.~      All patients will be screened for their physical ability to complete the interventional~     exercise program. Only patients capable and willing to take part in this study and meeting~     all inclusion and exclusion criteria will be randomized.~      All patients are to receive identical counseling for ideal nutritional, life-style and~     physical activity.~      Patients randomized to Arm 2 will additionally undergo a controlled and observed program of~     physical activity for a period of 6 months. Thereafter the patients are expected to adhere to~     a comparable, unobserved exercise program at home.~   "
166616|NCT01384825|"~     The presence of abnormalities in the cerebral venous circulation, defined as Chronic~     Cerebrospinal Venous Insufficiency (CCSVI), has recently been reported in patients with~     Multiple Sclerosis (MS), in healthy subjects and in subjects with other neurological~     diseases. These reports have aroused much interest both in the scientific world and, above~     all, among the communities of patients and Associations having the aim of aiding people with~     MS and of promoting scientific research into this disease.~      In the literature published so far there is a lack of verification in large samples of the~     prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with~     other diseases of the nervous system.~      This is an observational study investigating the prevalence of CCSVI in subjects with MS and~     comparing it with the prevalence observed in a control population consisting of Healthy~     Controls (HC) and in a population affected by other neurological diseases of the central~     nervous system of degenerative, vascular, inflammatory and autoimmune origin.~      A total of at least 1,200 adults with MS will be included in the study, as well as 400~     healthy subjects and 400 subjects with other neurodegenerative diseases.~   "
166617|NCT01384812|"~     The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation~     of brain vessels in migraine patients without aura.~   "
166618|NCT01384799|"~     This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin~     and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a~     multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human~     epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is~     designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101~     when administered in combination with concurrent cisplatin and radiation over an 8-week~     treatment course, consisting of a one week run-in period of CUDC-101 administered alone,~     followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation~     therapy.~   "
166619|NCT01384786|"~     Patients with hyperthyroidism and/or goiter are evaluated with blood samples and scintiscan~     before they are treated with radioiodine for their thyroid disease. Because the investigators~     do not get a histologically/final diagnosis the investigators want to make sure, that the~     patients treated do not have a thyroid cancer when treated.~      The investigators have found that thyroid cancer is not overlooked.~   "
166620|NCT01384773|"~     Keratoconus and pellucid marginal degenerations are genetically based ocular conditions and~     post surgical ectasia is an iatrogenic condition. These diseases are characterized by~     weakening of the front part of the eye that causes thinning and distortion. This distortion~     results in unevenness of the cornea and produces progressive near-sightedness and~     irregularity, which causes loss of vision when using eyeglasses. When eyeglasses fail to give~     enough vision, the the investigators use rigid contact lenses to create an artificial front~     eye surface. This improves visual acuity in many patients although they eventually fail~     either because they cannot be tolerated or the surface irregularity has become so severe that~     they are rejected. At this stage there is usually thinning and loss of clarity of the eye.~      There has been no treatment for this other than corneal transplantation, a complex surgical~     procedure with a significant complication rate and a delay in visual recovery. The treatment~     the investigators wish to perform strengthens the front of the eye by a chemical reaction~     using light and riboflavin. This technique has been studied over a decade and is widely used~     throughout the world. The FDA approved multicenter American clinical study is being analyzed~     in anticipation of its submission to the FDA for PreMarket approval. Because this is a~     progressive condition, the investigators wish to be able to offer this on a limited basis to~     patients in need with vision loss.~      Any treatment that can delay or prevent corneal transplantation is of great benefit. The~     investigators believe the evidence is compelling that this treatment is the sole alternative~     to surgical transplantation.~   "
166621|NCT01384760|"~     Obstructive sleep apnea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB)~     characterized by repetitive episodes of cessation of breathing during sleep due to upper~     airway collapse. It causes sleep fragmentation, disabling daytime sleepiness, impaired~     cognitive function and poor quality of life. In addition, OSAS is associated with non-fatal~     and fatal cardiovascular consequences including sudden death, in addition to an increased~     risk of road traffic accidents. Continuous positive airway pressure (CPAP) is considered as~     the first-line treatment for OSA. Oral appliance has been shown to reduce the severity of~     sleep disordered breathing and leads to symptomatic improvement especially in mild to~     moderate OSA. The compliance with CPAP is low particularly in mild or moderate OSA patients~     and it is not a curative treatment of OSA. It has to be used in every night on a regular~     basis. Weight reduction has always been advocated in patients with OSA who are overweight and~     may lead to improvement in the severity of OSA. The existing studies about weight loss are~     limited by small sample size, short duration (<6 months), focus on very low calorie diet~     program or surgically induced weight loss program only. However, none of them have applied~     lifestyle modification program (LMP) which emphasizes on long term lifestyle and behavior~     change. Therefore, the investigators plan to conduct a randomized controlled trial among~     Chinese OSA patients by comparing the efficacy of LMP against usual clinical lifestyle advice~     alone on the improvement of OSA symptoms.~   "
166622|NCT01384747|"~     -  Fimasartan will be more beneficial in stabilizing the plaque vulnerability compared to~          control group in deferred coronary lesions.~        -  Fimasartan will be more beneficial in reducing total plaque volume compared to control~          group in deferred coronary lesions.~        -  Fimasartan will be more beneficial in reducing functional impairment of stenotic lesions~          (assessed by FFR:Fractional Flow Reserve) in deferred coronary lesions.~   "
197083|NCT00983645|"~     This study aims to compare outcomes in renal transplant recipients in the hispanic population~     based on their immunosuppressant regimens.~   "
166624|NCT01384721|"~     The study aims at pooling a large population of patients with suspected coronary artery~     disease (CAD) who underwent Computed Tomography Coronary Angiography (CTCA) and who were~     adequately stratified in the first place. Then the investigators will be able to assess the~     incremental value of CTCA in the stratification of prevalence of disease (non~     obstructive/obstructive) and prognosis of patients with suspected CAD). The added information~     to current evidence is how reliable and to what extent CTCA can define the actual burden of~     disease and cardiovascular risk.~   "
166625|NCT01384708|"~     The overall objective of this study is to determine whether high-resolution imaging of the~     esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and~     discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME)~     was developed by our collaborators at Rice University and provides > 1000x magnified images~     of the esophageal mucosa. The purpose of this study is to determine whether this device can~     be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell~     cancer of the esophagus.~   "
166626|NCT01384695|"~     The overall objective of this study is to obtain data to evaluate whether high-resolution~     imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic~     (precancerous) areas. This is an exploratory study of a confocal endoscope designed to~     evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of~     subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope~     provides real-time in vivo microscopic images of the mucosa which resemble standard~     pathology.~   "
166627|NCT01384682|"~     MARCH is an international, multicentre trial planning to enroll 380 HIV-1 infected patients~     who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will~     be randomized (1:2:2) to one of three treatment groups: to continue their current treatment~     regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily~     with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic~     assessment of tropism cannot be used to determine tropism, instead we will employ the~     genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim~     of this study is to investigate whether switching to maraviroc, in combination with either~     RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI~     with PI/r. The other aim is to see if switching to these combinations with maraviroc will~     improve some of the side effects that can be seen when people take combination therapy~     including RTI and PI/r.~      The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200~     copies/mL) patients with no history of prior virological failure, a switch to either MVC~     dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC~     dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the~     investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral~     efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.~   "
166628|NCT01384669|"~     In this study, the investigators look at the genetic expressional alteration which influenced~     on the early lateral neck node metastasis in thyroid papillary microcarcinoma.~   "
166629|NCT01384656|"~     Patients undergoing multivessel off-pump coronary bypass surgery (OPCAB) inevitably~     experience cumulative ischemia-reperfusion injury at myocardium. Glucose-insulin-potassium~     (GIK) is a potentially useful adjunct to myocardial protection. This study was designed to~     evaluate the effects of GIK infusion on myocardium in patients undergoing OPCAB. Patients~     undergoing OPCAB with acute coronary syndrome are randomly assigned to GIK or Control group.~     The trial is double-blind and conducted at a single center.~   "
166630|NCT01384643|"~     Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting~     patient outcome following cardiovascular surgeries. Propofol, an intravenously administered~     anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to~     investigate the ability of propofol to protect kidneys against I/R injury in the patients~     undergoing valvular heart surgery.~   "
166631|NCT01384630|"~     This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in~     subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of~     RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42~     for a total of 3 injections. Study drug will be administered under close observation in a~     facility equipped to handle medical emergencies. Subjects will not be discharged from the~     facility until at least 1 hour following the end of the injection or 1 hour after their vital~     signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements~     of vital signs, clinical laboratory assessments, and the recording of adverse clinical~     events.~   "
166632|NCT01384617|"~     The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases~     pancreatic fistula following distal pancreatectomy, compared with stapling closure of the~     pancreatic stump.~   "
166633|NCT01384604|"~     The overall goal of this project is to identify intermediate phenotypes for psychosis across~     the schizophrenia and bipolar disorders boundary with implications for future genetic~     studies. Recent studies provide considerable evidence that schizophrenia and psychotic~     bipolar disorder may share overlapping etiologic determinants. Identifying disease-related~     genetic effects is a major focus in schizophrenia and bipolar research, with enormous~     implications for diagnosis and treatment for these two disorders. Efforts have been~     multifaceted, with the ultimate goal of describing causal paths from specific genetic~     variants, to changes in neuronal functioning, to altered brain anatomy, to behavioral and~     functional impairments. Parallel efforts have identified and refined several alternative~     endophenotypes that are stable, heritable, have (partly) known biological substrates, and are~     associated with psychosis liability. Although many such endophenotypes have been individually~     studied in schizophrenia, and to a lesser extent in bipolar disorder, no study has~     comprehensively assessed a broad panel of these markers in the two disorders with parallel~     recruitment, and the extent to which they mark independent aspects of psychosis risk, or~     their overlap in the two disorders. In this research project, we will examine a broad panel~     of putative endophenotypes in affected individuals and their first degree, biological~     relatives in order to: 1) characterize the degree of familial phenotypic overlap between~     schizophrenia and psychotic bipolar disorders; 2) identify patterns of endophenotypes unique~     to the two disorders; and, 3) contrast the heritability of endophenotypes across the~     disorders. We will obtain measures of neurophysiology (e.g., eye tracking, P50 gating, PPI,~     and P300), neurocognition (e.g., attention/vigilance, episodic and working memory), and brain~     structure (e.g., volumes of gray and white matter in specified brain regions). Blood samples~     will also be collected and stored for formal DNA linkage analyses using the independent~     phenotypes identified above. All volunteers will also be given the option to donate dermal~     biopsies for future research studies.~      Establishing similarities and differences in the endophenotypic signatures within~     schizophrenia and bipolar families will provide important insights for future genetic~     studies, and clarify concepts about common and distinct aspects of pathophysiology,~     potentially meaningful heterogeneity with disorders, and the clinical boundaries of the two~     most common psychotic disorders in adult psychiatry. This line of investigation will~     potentially impact our conceptualization of psychotic disorders, help us make critical~     strides to identify the pathophysiology of psychosis, and guide development of new specific~     treatments targeting particular deficits.~   "
166634|NCT01384591|"~     The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and~     impaired capacity for building muscle. In aging populations, this decreased ability to build~     muscle may represent a tipping point in the progression towards chronic physical frailty and~     disability. The goal is to examine whether novel pharmacologic therapies can improve~     nutritive blood flow to the muscles and muscle building in the elderly.~      The purpose of this study is 1) to determine if losartan administration will enhance blood~     flow and 2) to determine if N-acetylcysteine (NAC) will enhance blood flow.~      The investigators will study community dwelling, healthy older men and women (60-85 years).~     Subjects will be randomized to one of three groups:~      Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group~     2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3:~     N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo~      Subjects will admit to the clinic on day 1 of the study. Baseline testing consisting of leg~     blood flow (LBF), contrast enhanced ultrasound, handgrip testing and fatigue questionnaires.~     After testing is completed the subjects will recieve their first dose of NAC/ losartan/~     placebo with dinner. Subjects will be fasted after 10 pm. On day 2, leg blood flow (LBF) will~     be measured approximately 12 hours post dose 1. Subjects will receive their second dose of~     NAC/ losartan/ placebo. Leg blood flow will be measured 1 hour and 2 hours post dose 2 of~     study interventions. The subjects will eat a meal and receive their third dose of the study~     intervention. Leg blood flow will be repeated at 1 hour and 2 hours post dose 3. Appoximately~     30 minutes after dose 3 of the study intervention, handgrip testing will be performed and~     fatigue questionnaires completed.~   "
166635|NCT01384578|"~     120 patients of biopsy proven NASH will be randomized into two groups. Cases group will~     receive combination of pentoxiphylline and Vitamin E, and control group will receive only~     Vitamin E.~   "
166636|NCT01384565|"~     Study Design~      50 patients will be enrolled and randomized into patients (Group IA) and controls (Group I B)~      Investigations:~      Hematology CBC, Prothrombin time and INR Peripheral smear, Retics Biochemistry Liver function~     testing, AFP Kidney function testing Etiology of chronic liver disease Infectious etiology:~     total antiHBc, anti HCV, HCV RNA, HBV DNA Non infectious etiology: Autoimmune markers, copper~     studies, iron studies, HOMA IR, FBS Etiology of decompensation Variceal bleed Infection (~     blood culture, urine culture, sputum culture, chest xray) Surgery Drugs Alcohol intake~     Ascitic fluid analysis UGI endoscopy Imaging USG abdomen with Doppler for spleno-portal axis~     CECT- Triple phase upper abdomen Liver regenerative potential efficacy testing Histology ( by~     transjugular liver biopsy) Liver Dendritic cells ( CD11c, CD40, CD 54, CD 123, BDCA 2~     staining) by flow cytometry CD 34+ cells, CD 45+ cells and CD 133+ cells measurement in~     hepatic venous blood, peripheral blood and liver biopsy by flow cytometry Markers of~     proliferation like Ki- 67, proliferating cell nuclear antigen (PCNA) in liver biopsy Markers~     of angiogenesis like VEGF, v WF in hepatic venous blood Measurement of Hepatic venous~     pressure gradient ( HVPG)~   "
166637|NCT01384552|"~     The objective of this study is to determine the independent and combined effects of weight~     status and the level of dietary restraint on the relationship between package unit size and~     food intake.~   "
166638|NCT01384539|"~     The purpose of this study is to determine whether nutritional (cholecalciferol) or active~     vitamin D (calcitriol) supplementation improves vascular endothelial function in patients~     with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The~     investigators hypothesize that the use of calcitriol supplementation will result in improved~     vascular endothelial function as compared to cholecalciferol supplementation.~   "
166639|NCT01384526|"~     Ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal~     women receiving treatment for early stage breast cancer. However, the impact of long-term~     endocrine therapy on ovarian function is not established, and to our knowledge, has never~     been directly studied. Understanding the effects of hormone therapy on ovarian aging will~     help breast cancer patients of reproductive age make more informed and empowered decisions~     regarding their treatment. The purpose of this study is to explore the relationship between~     tamoxifen therapy and ovarian aging. Patients will be identified through the UCSF Cancer~     Registry and California Pacific Medical Center Cancer Registry and will be evaluated based on~     age and menopausal status. Women who read about the study from clinicaltrials.gov and contact~     the study coordinator will also be considered for enrollment. The age of menopause onset will~     be assessed through surveys and will be compared to the accepted national average age of~     natural menopause. Biomarkers of ovarian reserve will be assessed in premenopausal women~     between ages 25-45 and will be compared to those of healthy age- and ethnicity-matched~     premenopausal controls from an ongoing RO1- funded prospective longitudinal ovarian aging~     (OVA) study.~   "
166640|NCT01384513|"~     The purpose of this research study is to compare the survival rates of patients with better~     risk disease undergoing hematopoietic stem cell transplant (HSCT) to the survival rates~     reported in the medical literature of similar patients undergoing reduced intensity HSCT from~     matched related donors.~   "
166641|NCT01384500|"~     Patients who are intubated (breathing tube in windpipe) are often transported by air~     ambulance. Changes in atmospheric pressure during flight may cause pressure increases in the~     air-filled cuff holding the tube in the windpipe. Studies show that more than half the~     patients had potentially harmful pressures in the cuff during flight. High pressures lead to~     complications, such as injury to the windpipe. To avoid injury, cuff pressures must be kept~     at a safe level. There are many ways to avoid unsafe cuff pressures. One is to inflate the~     cuff with sterile fluid instead of air. Fluids are not subject to changes in atmospheric~     pressure. Using fluid, instead of air, in the cuff causes less pressure increases and less~     windpipe injury. The use and safety profile of this during transport by air ambulance has not~     been studied. This study compares tracheal tube cuff pressures, filled with air or fluid, at~     routine flying altitudes during patient transports by air ambulance.~   "
166642|NCT01384487|"~     The primary objective of this clinical study is to compare the Nidek RS-3000 Optical~     Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to~     evaluate any adverse events found during the clinical study.~   "
166643|NCT01384474|"~     This multicenter cluster-randomized trial will evaluate the impact of Crew Resource~     Management training on the occurrence of postoperative complications and the adherence to a~     surgical safety checklist, among a large sample of French surgical departments.~   "
166644|NCT01384461|"~     This observational study will evaluate the safety, tolerability and efficacy of~     RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to~     severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on~     treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate~     (weekly dose at the discretion of the physician).~   "
166645|NCT01384448|"~     The purpose of this study is to determine whether stress echocardiography or computed~     tomography (CT) of the heart is better at diagnosing emergency room chest pain patients to~     select appropriate candidates for hospitalization and further work-up.~   "
166646|NCT01384435|"~     The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to~     placebo in patients with Spinocerebellar Degeneration (SCD).~   "
166647|NCT01384422|"~     -  Thirty six patients suffering from active rheumatoid arthritis despite continued~          treatment with methotrexate will be evaluated for improvement of disease activity when~          taking GLPG0634 or matching placebo for 4 weeks.~        -  During the course of the study, patients will also be examined for any side effects that~          may occur, and the amount of GLPG0634 present in the blood as well as the effects of~          GLPG0634 on disease- and mechanism of action-related parameters in the blood will be~          determined.~   "
166648|NCT01384409|"~     To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using~     multi-center, non-comparative, open-label method in patients diagnosed as disseminated~     intravascular coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC~     criteria.~   "
166649|NCT01384396|"~     To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using~     multi-center, non-comparative, open-label method in patients diagnosed as disseminated~     intravascular coagulation (DIC) by the diagnostic criteria for DIC established by the~     Japanese Ministry of Health and Welfare.~   "
166650|NCT01384383|"~     This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral~     efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451~     + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in~     treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC~     genotype.~   "
166651|NCT01384370|"~     In both the ASC-US Study and Adjunct Study populations, the objectives are to:~        -  evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical~          disease in women with APTIMA HPV Assay positive results and~        -  evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45~          in women with APTIMA HPV Assay positive results.~   "
166652|NCT01384357|"~     The objective of the present study was to compare ultrasound (US) characteristics and~     ultrasound-guided core-needle biopsy (US-CNB) with US-guided fine-needle aspiration (US-FNA)~     in the assessment of different malignant cervical lymphadenopathies. Patients with malignant~     cervical lymphadenopathie with either US-FNA or US-CNB over a 3-year period from 2007 July to~     2010 Dec were retrospectively reviewed. There are two major study groups according to the~     treatment status of the patient's population, including patients who had pathology proofed~     previous cancer and with clinically cervical lymphadenopathies after treatment. The second~     group included patients with cervical lymphaenopathies but without previous diagnosis of~     malignancy and treatment. The results of cytology, or pathology and time of needle biopsy to~     final diagnosis were traced and recorded. Morphologic US parameters and vascular features~     were thoroughly evaluated and compared in different disease.~   "
166653|NCT01384344|"~     Cognitive and memory disorders are characterized of Alzheimer disease. In addition,~     psychologic and behavioural symptoms, called speak neuropsychiatric symptoms, are frequents~     and play an important role in prognostic and intervention. These symptoms are noticed before~     the diagnostic of dementia, their prevalence and their intensity increase with the evolution~     of disease. Apathy, which is characterized by a decrease of motivation, is the most frequent~     of this behaviour disrupt. Clinically, a decrease, or a totally, lack of interest, initiative~     and blunting emotional are noticed. Fundamentally, apathy is considered as a decrease of~     cognition and behaviour to go in goal. Assessment of psychological and behavioural symptoms~     is realised principally with neuropsychiatric scales. These contribute to obtain particular~     informations about health of patient allowing by patient and caregiver discussions and~     impressions of clinician. These scales are simples but loss of subjectivity. An alternative~     of this method is the use of gerontechnology as actigraphy (system out-patient which records~     locomotive activity with the help of piezo-electrical sensor fixed on a bracelet) and video~     recording which is associated to an informatic treatment of signal in order event~     recognition.~      The aim of study is to realise an objective assessment of activities go in goal during~     experimental sequence which has well-characterized acts, using at the same time an~     actigraphic record of activity motive (system of assessment indirect of apathy fit) and a~     video records which uses an informatic event recognition system. The assessment will realise~     with participants controls (n=30) and Alzheimer disease patients with (n=20) or without~     (n=20) apathy, during well-characterized records. The final aim is to obtain a particular~     assessment of some disorders behaviours, as apathy, which is principally characterize by a~     decrease of behaviours to go in goal.~   "
166654|NCT01384331|"~     Most Implanon users experience a reduction in the frequency and volume of menstrual bleeding,~     but a substantial minority experience unpredictable and frequent and/or prolonged episodes of~     bleeding. This is a double blind, placebo controlled, randomised study with an additional~     randomised non-blinded arm. Two hundred women between the ages of 18-45 years, who are~     Implanon users with prolonged or frequent breakthrough bleeding (WHO definition) will be~     recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to Marvelon~     7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a daily~     menstrual diary chart for a minimum of 90 days prior to randomisation, and will be enrolled~     into the treatment phase provided that they have met one of the World Health Organization~     criteria for prolonged or frequent bleeding Following the initial 90 day record, eligible~     women will begin designated treatment on day 1 of the next episode of bleeding or spotting.~     Analysis of the subsequent menstrual pattern will begin from day 1 of that bleeding/spotting~     episode and will continue through 90 days.~   "
166655|NCT01384318|"~     In common clinical practice, one means of ensuring an acceptable cuff pressure in~     endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O~     and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of~     this study is to validate this technique by checking the intracuff pressure using a manometer~     after the cuff is inflated using the CPAP technique.~   "
166705|NCT01383668|"~     This phase I trial studies the side effects and best dose of sirolimus and gold sodium~     thiomalate when given together in treating patients with advanced squamous non-small cell~     lung cancer (NSCLC). Sirolimus and gold sodium thiomalate may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth~   "
197084|NCT00983632|"~     The investigators would like to explore possibilities of selective vagus nerve stimulation in~     human subjects to control heart rate and arterial blood pressure.~   "
166656|NCT01384305|"~     Even though rare disorders usually have limited case numbers, they have induced huge impacts~     on patients and their families, and has heavily burdened on our society and healthcare system~     as well. Therefore, it is essential to detect the occurrence of disorders and thus take~     appropriate measures as early as possible. The preventive goal is based on comprehensive~     understanding on rare disorders, available diagnostic and therapeutic approaches. However,~     studies related to rare disorders are often impeded by limited sample sizes and infrequent~     exchange of research materials among institutes. After referring to foreign experiences, the~     investigators have noticed that a non-profit tissue bank which can reposit biological samples~     and thus provide researchers access to samples, may be a solution. Through sharing this~     public asset, the investigators believe not only quantity and quality of rare disorder~     studies will be improved, the collaboration between various research institutes can also be~     strengthened afterwards. Most important of all, those achievements can ultimately benefit~     patients, families and the whole society.~   "
166657|NCT01384292|"~     The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment~     of opioid-induced constipation (OIC) in patients with cancer-related pain, including those~     patients that have inadequate response to laxative therapy (LIR).~      The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week~     extension with active treatment (part B).~   "
166658|NCT01384279|"~     The primary aim of the study is to investigate the efficacy of metformin and topiramate on~     second-generation antipsychotic-induced obesity. The secondary domain we look at is the~     adverse effects of both drugs. The investigators hypothesize that metformin and topiramate~     are effective in treating obesity induced by second-generation antipsychotics.~   "
166659|NCT01384266|"~     Patients are routinely given steroid eye drops following cataract surgery. This study will~     compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used~     following cataract surgery. Patients will be randomly assigned to one drop or the other, and~     evaluated for inflammation and intraocular pressure as part of the comparison. The study~     Doctor will be masked as to which drop the patient receives to avoid bias.~   "
166660|NCT01384253|"~     Monoclonal antibodies can transport and deliver radioactive elements capable of releasing~     sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study~     alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path~     length targeted to malignant cells by the trastuzumab antibody, as a potential treatment for~     metastatic diseases.~      This Phase I trial is designed to determine the toxicity profile of ²¹²Pb-TCMC-Trastuzumab,~     its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive~     intraperitoneal cancers.~   "
166661|NCT01384240|"~     The overall objective of this study is to obtain data to evaluate whether high-resolution~     imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and~     neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope~     device which can be used during standard endoscopy to image the gastrointestinal epithelium.~     Theoretically, by visualizing superficial mucosal changes at a high-resolution and~     magnification, the investigators will be able to obtain optical images that can be used to~     guide endoscopic biopsy and polypectomy. This may foster the selective targeting of~     dysplasia/neoplasia, thereby improving diagnostic accuracy.~   "
166662|NCT01384227|"~     The overall objective of this study is to obtain data to evaluate whether high-resolution~     imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic~     (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope~     device which can be used during upper endoscopy to image the gastrointestinal epithelium.~     This is an exploratory, not a comparative, study designed to evaluate the feasibility of~     using this instrument in Barrett's esophagus.~   "
166663|NCT01384214|"~     The purpose of this study is to evaluate swallowing efficiency in patients with cervical~     dystonia following treatment with botulinum toxin Type A.~   "
166664|NCT01384201|"~     This is a prospective randomised study investigating the use of chromoendoscopy and confocal~     laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of~     gastric cancer.~   "
166665|NCT01384188|"~     The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and~     morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal~     women.~   "
166666|NCT01384175|"~     The aim of the present study was to assess the efficacy of thoracic epidural anesthesia~     followed by postoperative epidural infusion and patient-controlled epidural analgesia with~     ropivacaine/fentanyl in off-pump coronary artery bypass grafting~   "
166667|NCT01384162|"~     This is an open label safety and tolerability continuation study of intracerebroventricular~     administration of sNN0029, containing the growth factor VEGF165, in patients with amyotrophic~     lateral sclerosis that have previously participated in study sNN0029-001. The intention of~     the study is to investigate safety and tolerability of intracerebroventricular administration~     of sNN0029 and whether it can improve motor function and prolong survival in patients with~     ALS.~   "
166668|NCT01384149|"~     The purpose of this study is to evaluate the advantages and disadvantages of external~     selective laser trabeculoplasty (SLT) in treating open angle glaucoma,compared to traditional~     SLT.~   "
166669|NCT01384136|"~     The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in~     cases of genetic instability and secondary to stress.~      The investigators aim is to study the telomere system in cord blood and in the placenta~     immediately after the delivery in pregnancies defined as high risk pregnancies following~     sterss events such as placental insufficiency, preeclampsia, diabetes.~      The investigators intend to compare the telomere system in maternal blood to cord blood and~     to placental biopsies and to study the influence of different stressogenes on this system.~   "
166724|NCT01383421|"~     This study is a non-confirmatory post-marketing observational study to explore and describe~     the effectiveness of adalimumab on rheumatoid arthritis (RA) treatment course and participant~     satisfaction over time in context with utilization of a patient support program (PSP). The~     core elements of the PSP were call centers (in and outbound)/hotlines, nursing services,~     starter packs, provision of educational materials (print and digital) regarding RA and~     adalimumab, and injection guides. Other elements of the PSP, which varied between countries,~     included (but were not limited to) refill reminders, email contacts, support groups, and~     newsletters.~   "
166670|NCT01384123|"~     Sarcoidosis is a heterogeneous multisystem disorder of unknown etiology which often presents~     with bilateral hilar lymphadenopathy, pulmonary infiltration and ocular and skin lesions. In~     addition to possible changes in forced vital capacity (FVC) and carbon monoxide transfer~     factor (TLCO), a higher prevalence of clinical depression, reduced health status and exercise~     intolerance have been observed in patients with sarcoidosis.~      Reduced health status has been related to decreased pulmonary function, depressive symptoms,~     and to respiratory muscle weakness. Exercise capacity is believed to be limited by dyspnea,~     an insufficient heart rate response, decreased arterial oxygen tension during exercise,~     excessive and inefficient ventilation and by respiratory muscle weakness.~      In the past, exercise capacity was shown to be limited by skeletal muscle weakness in~     patients with chronic pulmonary or cardiac disease. 67% of the sarcoidosis patients studied~     by Miller et al terminated their peak exercise test due to leg complaints. Skeletal muscle~     weakness is therefore still assumed to be present in patients with sarcoidosis.~      Treatment with oral corticosteroids, clinical symptoms of depression, myositis, self-reported~     complaints of fatigue and high circulating levels of tumour necrosis factor-α (TNF-α) are all~     present in patients with sarcoidosis and can all affect skeletal muscle force and exercise~     capacity. Additionally, low levels of circulating insulin-like growth factor I (IGF-I), which~     can be induced by high levels of TNF-α, and high circulating levels of interleukin (IL)-6 and~     IL-8 (CXCL8) have been associated with skeletal muscle weakness. These interleukins are part~     of the current concept of the immunopathogenesis of sarcoidosis16 and may be raised in~     patients with stable sarcoidosis.~      Recent studies have shown that pulmonary rehabilitation program can lead to improve in the~     health status and anxiety among patients with chronic obstructive lung disease .However, no~     study has evaluated the role of pulmonary rehabilitation among patients with sarcoidosis.~   "
166671|NCT01384110|"~     The primary endpoint of this trial will be to evaluate if a single administration in human of~     a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce~     postprandial glycemia and insulinemia.~   "
166672|NCT01384097|"~     A systematic literature search a goal-directed haemodynamic algorithm was created. The~     hypothesis of this study was that the goal-directed haemodynamic algorithm is feasible and~     can improve clinical outcome.~   "
166673|NCT01384084|"~     The investigators have performed colposacropexy in women with uterovaginal prolapse for many~     years with satisfactory results.~      This study was designed to compare whether, in the treatment of patients with uro-genital~     prolapse and urinary incontinence, the addition of a contemporary anti-incontinence procedure~     such as mini-sling is associated with a reduction of post-operative urinary incontinence~     (correction of pre-existent urinary incontinence and prevention of masked urinary~     incontinence).~   "
166674|NCT01384071|"~     Some physicians, physiotherapists and nurses use or even suggest unstable shoes in cases of~     low back pain. No studies on the real effects of these shoes on low back pain in health care~     professions have been carried out and therefore as yet there is no real evidence of their~     effectiveness. Thus the investigators assume that wearing unstable shoes over a period of six~     weeks could reduce low back pain and functional disability due to the changes of the gait and~     posture and may increase the quality of life.~      The purposes of this study are:~        1. To evaluate the modifications of pain level, functional capacity and quality of life~          among individuals with moderate level of non-specific chronic low back pain after~          wearing unstable shoes.~        2. To quantify biomechanical modifications of gait and posture.~   "
166675|NCT01384058|"~     It is of interest how ezetimibe alone or in combination with statin may influence atherogenic~     dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary~     objective of this study will be whether there is a change of the concentrations of~     Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.~   "
166676|NCT01384045|"~     Using a socioeconomic, race/ethnic, and gender-diverse sample of patients who receive~     diabetes care from a University of Colorado Hospital (UCH) primary care provider (PCP), carry~     out a randomized-controlled trial of usual care versus an outreach intervention designed to~     increase guideline concordance with American Diabetes Association (ADA) recommendations for~     blood pressure, Low-density lipoprotein (LDL), and glycosylated hemoglobin (A1c) goals,~     referrals for retinal exams, and aspirin therapy.Primary hypotheses: The proportion of~     patients meeting goal will be 10% higher in the intervention compared with control group in~     the following domains: 1. LDL<100 mg/dL; 2. A1c<7.0%; and 3. Systolic blood pressure<130 mm~     Hg or diastolic blood pressure<80 mm Hg.~   "
166677|NCT01384032|"~     Cardiovascular disease (CVD) is recognised as one of the main causes of death in the western~     world. LDL- cholesterol ('bad' cholesterol) and other lipids (fats) are important CVD risk~     factors. Apolipoprotein E (apoE) is an important transporter of fats in the blood. ApoE comes~     in E2, E3 and E4 forms, depending on your genetic make up. Approximately 60% of the UK~     population are E3/E3, 25% E4 carriers and 15% E2 carriers. There is some evidence to suggest~     that an E4 genotype may put you at modestly higher risk of CVD. Furthermore although very~     inconclusive previous studies have suggested that E4 individuals are slightly more sensitive~     to the LDL-cholesterol modifying effects of dietary fats (saturated fat, total fat, fish oil)~     showing slightly, greater reductions when low levels of these fat are consumed, and greater~     increases when high levels of these fat are consumed. Therefore, the aims of the Satgene~     study is to examine the impact of modifications in dietary total fat and saturated fat~     intakes, alone and in combination with fish oil supplement on LDL-cholesterol and other blood~     lipids, in individuals with an E3 and E4 genotype. The levels of total fat and saturated fat~     used in the current study are within the range observed in a typical UK population.~   "
166678|NCT01384019|"~     The investigators examined the mechanism underlying the lack of benefit from distal~     protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial~     Infarction (STEMI) in a prospective, randomized trial.~   "
166679|NCT01384006|"~     To expand the donor pool for pancreas allografts. For detailed description please see below.~   "
166680|NCT01383993|"~     In this study we will measure the concentration of the drug called voriconazole which is used~     to fight infections caused by fungus in children who usually are cancer patients and have~     their immune system down. Since we know the dose in adults, and we think we know the matching~     doses in the young patients ages 2 to less than 15 years old, we will compare the amount of~     drug that goes into the system with what we know works in adults. We give the drug by a~     needle directly into the blood, then few days later we stop that and give the drug by mouth.~     Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.~   "
166681|NCT01383980|"~     Surgical patients fed up until the point of surgery will have safe delivery of more calories~     compared to a group whose feeding is held at midnight prior to surgery.~   "
166968|NCT01380249|"~     This phase I study in adult patients with advanced solid tumours is designed to evaluate~     toxicity, drug exposure (pharmacokinetics) and drug action (pharmacodynamics) of a new~     molecule, PDM08, administered twice a week cycles of 4 weeks. This drug has shown antitumoral~     activity in several murine cancer models.~   "
166682|NCT01383967|"~     This is a two part study. Part A is a multiple-ascending dose study in up to 6 different~     groups of healthy subjects, with approximately 12 subjects in each of the groups. Part A will~     allow investigation of up to 6 different doses of LY2979165. The drug will be administered~     for a total of 14 days. Subjects will be resident in the clinical research unit (CRU) from~     Day -1 (the day before dosing) until Day 15.~      Part B will investigate a dose of LY2979165 previously administered in Part A in up to 12~     subjects. The drug will be administered for a total of 14 days. In addition to the same~     assessments as would have been completed in Part A, subjects in Part B will also have~     cerebrospinal fluid samples taken from the lower lumbar region of their spine.~   "
166683|NCT01383954|"~     The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA)~     patients using the diclofenac gel.~   "
166684|NCT01383941|"~     This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic~     characteristics of Difficult-to-Treat asthma, among children between the ages of 6 to 17~     years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis.~   "
166685|NCT01383928|"~     This will be a phase 1/2, multicenter, open-label study using the oral formulation of~     IXAZOMIB administered twice weekly in combination with lenalidomide and low-dose~     dexamethasone. Both phases of the study will include patients who have newly diagnosed~     multiple myeloma and have not previously received systemic treatment.~      Both the phase 1 and the phase 2 portions of the study will include induction therapy~     consisting of 1 year of therapy followed by maintenance therapy that will continue until~     progressive disease or unacceptable toxicity. Maintenance therapy will be IXAZOMIB alone on~     Days 1,4,8, & 11 of a 21-day cycle.~   "
166686|NCT01383915|"~     Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode~     of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors~     of the disease development.~      Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of~     Bipolar Disorder (BPD) or schizophrenia.~      Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will~     differentiate between individuals developing BPD and schizophrenia.~   "
166687|NCT01383902|"~     This comparative pilot study is designed to compare the rates of gastric emptying and by~     inference rates of digestion of challenge meals. Two types of meal will be compared,~     chocolate mousse style dessert and chocolate bars. The information from this study will then~     be compared to the elicitation times for both objective and subjective symptoms in the~     allergic patients who have been challenged in a different study using the same two meals.~   "
166688|NCT01383889|"~     This will be an open randomized clinical trial involving pregnant women between 35 and 37~     weeks randomized to two modalities of exercise: treadmill or stationary bike. The study~     hypothesis is that exercise on a stationary cycle causes less maternal and fetal effects in~     relation to treadmill exercise.We will study the acute effects of exercise for both the~     mother and the fetus, monitoring the parameters before, during and after exercise for 20~     minutes. The exercise intensity will be moderate, remaining between 60% and 80% of maximum~     heart rate. Women will be monitored with a recording equipment of ABPM (ambulatory blood~     pressure monitorization) and continuous cardiotocography and blood will be collected to~     measure blood glucose, total cholesterol and HDL, nitrate and lactate before, during and~     after exercise. The analysis variables are: maternal heart rate and blood pressure, fetal~     heart rate, number of fetal movements, transient accelerations, decelerations, short-term~     variability, episodes of high variability, uterine tone, glucose, lactate, nitrate, total~     cholesterol and HDL.The analysis will be based on intention to treat, according to the~     recommendations of the CONSORT (2010).~   "
166689|NCT01383876|"~     Cervical collars are commonly used to provide external immobilization after elective~     Posterior Cervical Laminectomy and Interbody Fusion (PCLIF). The rationale for collar use is~     the perception and assumption that it can prevent early instrumentation failure and promote~     successful spinal fusion. However, there are a number of potential complications associated~     with cervical collars such as skin breakdown, ulceration, neck pain, impedance upon~     activities of daily living, and impaired swallowing. Considering these conflicting factors,~     there is wide disagreement among spinal surgeons about the utility, benefits, and necessity~     of collar use following elective PCLIF.~      Hypothesis: Wearing a cervical collar for 12 weeks after posterior cervical laminectomy and~     instrumented fusion will not demonstrate substantial benefits as measured by the incidence of~     instrumentation failure, rate of nonunion, or clinical outcome measures.~      Specific Aim I: To compare the outcomes of surgery in patients who will wear a cervical~     collar for 12 weeks following surgery versus those who will have the collar removed prior to~     discharge after surgery.~   "
166690|NCT01383863|"~     The purpose of the protocol is to assess the rate of castration resistance, disease~     progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT)~     induction in a study cohort of patients with advanced disease.~   "
166691|NCT01383850|"~     Infants born between 28 and 32 weeks' gestation with radiological findings and clinical~     symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway~     Pressure (NCPAP) within the first hour of life, were randomized to receive either standard~     medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life,~     followed by medical air until NCPAP was needed. The aim of the study was to assess the~     therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20%~     oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in~     terms of reducing the rate of mechanical ventilation (MV).~   "
166730|NCT01383343|"~     This phase I trial studies the side effects and best dose of sorafenib tosylate when given~     together with bevacizumab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil in~     treating patients with colorectal cancer that has spread to other parts of the body. Drugs~     used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Sorafenib tosylate may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and~     spread. Sorafenib tosylate and bevacizumab may also block tumor growth in different ways by~     targeting certain cells. Giving sorafenib tosylate and bevacizumab together with combination~     chemotherapy may be a better treatment for colorectal cancer.~   "
166692|NCT01383837|"~     Adolescents with substance use disorders (SUD) are at substantial risk for contracting~     HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction~     interventions have been developed to meet their unique needs, and none use a family-based~     intervention approach, which the literature recommends as the focus for intervention for~     youth. Current state policies neither require providers in clinics delivering substance use~     treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for~     HIV/STI prevention. There is clear public health need to develop innovative methods of~     service delivery and effective strategies of HIV/STI sexual risk reduction that address~     multiple contexts of risk (i.e. family) for this high risk population. The current proposal~     addresses this need by developing a provider-delivered HIV sexual risk reduction intervention~     to be implemented in outpatient SUD treatment that: 1) builds the clinics' capacity to help~     families under their care to more comfortably address the adolescent's sexuality; 2) promotes~     youth's safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents~     with SUD in care.~   "
166693|NCT01383824|"~     The purpose of this study is to monitor the performance and of the Silent Hip™ in the~     treatment of patients with hip joint disease requiring a total hip replacement. Patients who~     enter the study will be evaluated at regular intervals following hip surgery using patient,~     clinical and x-ray assessments.~   "
166694|NCT01383811|"~     The objective of this study is to determine the effects of adjunct exercise in treatment~     resistant depression. The central hypothesis for the research is that adjunct exercise with~     usual care in Treatment Resistant Depression (TRD) will have significant effects in improving~     the psychiatric symptoms in comparison to usual care alone.~   "
166695|NCT01383798|"~     The specific aims of the current study were: 1) To determine the prevalence of IDNA in a~     sample of female rowers at the beginning of a training season; 2) To determine how IDNA~     affects endurance training and performance at the beginning of a training season; 3) To~     determine how iron supplementation affects iron status, training and performance in IDNA~     female collegiate rowers. The researchers hypothesized that IDNA affects endurance~     performance in female collegiate rowers both in and outside of the laboratory, and that iron~     supplementation of IDNA rowers will improve iron status, and consequently, training quality~     via increased energetic efficiency.~   "
166696|NCT01383785|"~     Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the~     thrombus occlusion is better than normal injection during primary percutaneous intervention~     (PCI) for the treatment of acute myocardial infarction. Using this modification of injection~     method the investigators can achieve less microvascular damage and a reduction of the infarct~     size with a significant improvement of the outcome at six months.~   "
166697|NCT01383772|"~     The purpose of this study is to determine the risk of failing the visual field criteria to~     hold a driving license following retinal laser treatment delivered with a multi-spot~     photocoagulator.~   "
166698|NCT01383759|"~     The goal of this clinical trial is to determine the toxicity and also the efficacy of a~     treatment that includes the following treatment: Two medications, bortezomib and~     dexamethasone (or BD), followed by autologous stem cell transplantation, and a prolonged~     course of treatment with bortezomib and dexamethasone after transplantation. This type of~     treatment has been very effective in multiple myeloma. However, there is little experience~     with this treatment in patients who have Monoclonal Immunoglobulin Deposition Disease (MIDD)~     or amyloidosis. The investigators and others have treated patients who have MIDD and~     amyloidosis with bortezomib and autologous stem cell transplantation and have had success~     with this treatment. But the combination of autologous transplant with BD given before and~     after the transplant is a new way of treating these diseases, which the investigators believe~     will be very effective.~   "
166699|NCT01383746|"~     Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor~     prognosis (overall survival < 3% at 5 years). Less than 20% of patients may benefit from~     curative surgical resection and most patients have medical treatment by palliative treatment~     by palliative chemotherapy. It is not standard first-line chemotherapy validated for~     unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are~     observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4~     months). In case of tumor progression ater this first line therapy, no treatment is currently~     being validated.~      RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium~     microspheres.~      In the patients with unresectable CCK , the first pilot studies showed interesting results~     with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety.~      Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic~     CCK in tumor progression after first-line therapy.~   "
166700|NCT01383733|"~     This multicenter, open-label, multiple ascending dose study will evaluate the safety,~     tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with~     advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640~     intravenously, either weekly or every 2 weeks or every 3 weeks, until disease progression or~     unacceptable toxicity occurs.~   "
166701|NCT01383720|"~     This is a prospective, single-arm feasibility study designed to assess the acute safety and~     performance of the Lotus Valve System for transcatheter aortic valve replacement in~     symptomatic patients with calcified aortic valve stenosis and who are at high risk for~     surgical intervention.~   "
166702|NCT01383707|"~     The multicenter, open-label, single-arm, non-randomized, two-stage Simon's design, phase II~     study (The CLMO-001 Trial) will evaluate the efficacy and safety of bevacizumab in~     combination with mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU] and oxaliplatin) in~     participants with colorectal cancer and liver metastases. Participants will receive~     combination therapy of bevacizumab 5 milligrams per kilogram (mg/kg) intravenous (IV) dose~     and mFOLFOX-6 every 2 weeks during Cycles 1-5 and Cycles 7-12. Participants will receive~     mFOLFOX-6 alone (without bevacizumab) on Cycle 6. In between Cycle 6 and 7, participants will~     undergo liver surgery if operable. Thereafter participants will receive bevacizumab (5 mg/kg~     IV every 2 weeks) alone for 52 weeks (26 cycles) after the end of the post-operative phase~     (maintenance therapy). At the end of the preoperative treatment phase (Cycles 1-6),~     participants showing different alternative conditions admitted by the protocol will undergo~     different management (alternative study designs 1 to 3).~   "
166706|NCT01383655|"~     In infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing~     symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always~     satisfactory.~      The purpose of this trial is to investigate the effectiveness of iv-magnesium in the~     treatment of moderate or severe bronchial obstruction associated with viral infection in~     small children.~      The study population will include the children attending the Pediatric Emergency Department~     of Oulu University Hospital because of respiratory infection and bronchial obstruction that~     is not relieved with conventional treatment. After written consent from the parents, the~     children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl. The~     primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours from~     the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time points~     and length of hospital stay.~      The sample size is 64 children at the age of 6 months to 4 years.~      If iv-magnesium is effective in relieving viral infection associated bronchial obstruction,~     that would be an important addition to the treatment of this common disease.~   "
166707|NCT01383642|"~     Vestibular dysfunction is a known contributor to imbalance and fall risk, and may be a~     precursor to the frailty phenotype seen in the elderly population. A recent study found that~     vestibular dysfunction is common in the US population, and that the prevalence of this~     impairment increases steeply with age. However, it is unknown whether the aging process has~     global effects on the vestibular end-organ or whether specific structures, e.g. the~     semicircular canals or the otoliths, are selectively impaired. Moreover, the clinical~     implications of specific deficits of the vestibular end-organ are unclear. As such, the aims~     of this proposed research are: 1) to evaluate whether the normative aging process is~     predominantly associated with dysfunction of the semicircular canals (as measured by caloric~     and angular vestibulo-ocular reflex testing) or of the otoliths (as measured by VEMP~     testing); 2) to determine if there are any characteristic clinical features associated with~     the subtypes of vestibular dysfunction; and 3) to assess whether dysfunction of the~     semicircular canals or of the otoliths is associated with a higher risk of frailty and falls.~     The investigators plan to pursue these aims through a cross-sectional and prospective cohort~     study of a group of individuals age 70 and above. Vestibular physiologic tests will be~     administered to all study participants, and test results will be correlated with baseline~     clinical symptoms and frailty status as well as prospective one-year fall risk. A greater~     understanding of vestibular physiologic deficits and their clinical implications in older~     individuals can inform the development of rational vestibular rehabilitation strategies that~     may more effectively mitigate the frailty phenotype and reduce fall risk.~   "
166708|NCT01383629|"~     This RCT aims to study the effect of preoperative counselling in reducing patients fear and~     visual perception during vitrectomy under local anaesthesia.~   "
166709|NCT01383616|"~     Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression~     fractures has been shown to be successful in providing acute pain relief, enabling improved~     function, and restoring of vertebral body height. However, limited prospective data exists in~     the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to~     bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to~     compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon~     kyphoplasty.~   "
166710|NCT01383603|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis. Cat-PAD is a novel, synthetic, allergen derived peptide~     desensitising vaccine currently being developed for treatment of cat allergy.~      At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at~     the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently~     exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate clinical~     development of peptide immunotherapy vaccines, in addition to providing an improved~     understanding of the underlying molecular mechanisms of efficacy, thus providing new leads~     for therapeutic intervention.~   "
166711|NCT01383590|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis. Cat-PAD is a novel synthetic, allergen derived peptide~     desensitizing vaccine currently being developed for the treatment of cat allergy.~      At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at~     the conclusion of therapy. The aim of this study is to identify changes in potential~     biomarkers after peptide immunotherapy that may be subsequently developed as biomarkers that~     equate with clinical efficacy.~   "
166712|NCT01383577|"~     Rubber band ligation is a widely adopted treatment of internal hemorrhoids in busy~     coloproctology institutions. All three major hemorrhoidal clusters (left lateral, right~     anterior and right posterior) use to be ligated in order to obtain therapeutic success. It is~     commonly performed either through the ligation of a single hemorrhoid per session spaced by~     some few weeks to the second and third sessions, or of all three major hemorrhoids in one~     single session. Advocates of either method of hemorrhoidal ligation have arguments to defend~     their choice in terms of advantages, supported mainly on personal preferences. The~     investigators objective is to determine, through a controlled double-blinded randomized~     study, if there is any superiority of single hemorrhoidal ligation per session (in a total of~     three sessions) over the method of ligation of all three main hemorrhoids in a sole session~     in terms of therapeutic success (resolution of pre-ligation symptoms), morbidity, patient~     satisfaction and costs (institutional, labor and patient-related).~   "
166727|NCT01383382|"~     Using individualized patient estimates of procedural risks and benefits, this project will~     transform the process of informed consent for coronary angioplasty into a dynamic educational~     tool for patients and physicians and is a direct response to the Institute of Medicine's call~     for a more evidence‐based, efficient, patient‐centered healthcare system. It is hypothesized~     that patients will develop a greater understanding of their individual risks and benefits~     from PCI, will be empowered to more actively engage in shared decision-making, as well as~     have improved awareness of their responsibility to adhere to dual anti-platelet therapy if~     treated with a drug eluting stent (risks for target vessel revascularization with bare metal~     and drug eluting stents are also provided in the new consent form). It is also anticipated~     that physicians, in turn, will use these individualized estimates to better discriminate~     between risks and benefits among different bleeding avoidance therapies so as to improve the~     safety and cost-effectiveness of PCI.~   "
166713|NCT01383564|"~     Obstructive sleep apnea syndrome (OSAS) and asthma are both common disorders in Hong Kong,~     with prevalence of at least 4% among the middle-aged male Hong Kong (HK) Chinese populations~     and 7.2% in young adults respectively. OSAS is characterized by repetitive episodes of upper~     airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime~     sleepiness, impaired cognitive function and poor health status. Continuous positive airway~     pressure (CPAP) is the first line of therapy for sleep apnea. CPAP provides a pneumatic stent~     for the upper airway, eliminating the airway collapse during inspiration.~      Asthma is a chronic inflammatory disorder of airways, characterized by airway~     hyperresponsiveness that leads to recurrent episodes of wheezing, breathless, chest~     tightness, and coughing, particularly at night or in the early morning. Nocturnal asthma is~     not a different condition from asthma and is defined as a variable worsening of asthma at~     night, in which the mechanisms are not completely understood.~      The prevalence of OSAS in asthmatic patients has not yet been studied, but several studies~     have reported an increased prevalence of OSAS symptoms in asthmatic patients. OSAS and asthma~     share some common risk factors, which include obesity, gastroesophageal reflux and rhinitis.~     CPAP treatment has been shown in prospective clinical studies to have a positive impact on~     asthma outcome in patients with concomitant OSAS, for example, improvement of asthma related~     quality of life in subjects with stable mild-to-moderate asthma, but there was no change in~     the airway responsiveness or forced expiratory volume in one second. Although important,~     these studies included small numbers of participants used nonrandomized designs. This study~     is to assess the impact of CPAP treatment on asthma control among patients with nocturnal~     symptoms and moderate OSAS.~   "
166714|NCT01383551|"~     The proposed of this study is to determine if an intervention, known as the Becoming~     Parents programme, is more effective in improving the mental health, marital relationship~     and parental competence of expectant couples in a Chinese community.~   "
166715|NCT01383538|"~     The purpose of this phase I study to determine the optimal dose for the combination of~     IPI-926 plus FOLFIRINOX (5-fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin)~     chemotherapy in patients with pancreatic cancer.~   "
166716|NCT01383525|"~     The trial objectives are to establish the safety & efficacy of using a DLTP laser to perform~     laser trabeculoplasty to reduce Intraocular Pressure (IOP) in patients with open angle~     glaucoma (Including Pigmentary & Exfoliative Glaucoma), that did not achieve adequate IOP~     control by conventional therapy.~   "
166717|NCT01383512|"~     Upper limb motor control after a stroke may be improved with rehabilitation robotics at a~     subacute stage. The aim of this multicenter controled randomized single blind study is to~     define the place of rehabilitation robotics at this phase of the rehabilitation process. Both~     groups will realize the same time of rehabilitation. The cost benefit ratio will be compared~     in each group through medical assessment of improvement and definition of the costs due to~     the rehabilitation process.~   "
166718|NCT01383499|"~     The aim of this trial is to select an optimum dose may be selected based on bronchodilator~     efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.~   "
166719|NCT01383486|"~     A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their~     own use based on expected duration of pain greater than 12 hours.~   "
166720|NCT01383473|"~     Many children with cancer cannot participate regularly in school due to frequent~     hospitalizations for treatment or treatment related effects such as pain, nausea, and~     fatigue. Prior studies have shown that children with cancer desire to attend school while~     receiving therapy despite these challenges, and that they report psychological and~     psychosocial difficulties if unable to attend. While school attendance has been found to~     correlate with Health-Related Quality of Life (HRQoL), self-efficacy beliefs, and~     self-esteem, little is known about how children with cancer experience school attendance~     while receiving active cancer therapy. The purpose of this study will be to explore how 6-12~     year old children with cancer perceive school attendance pre and post diagnosis during active~     therapy as measured at one-time point, 6 months (± 2months) into active therapy.~   "
166721|NCT01383460|"~     50 patients of Acute-on-chronic liver failure (ACLF) will be enrolled and randomized into~     G-CSF+EPO or Placebo arms~      Treatment protocol To administer G-CSF (in prefilled syringe) at a dose of 5 µg/kg s/c at~     days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with~     Darbopoetin alpha 100 mcg/ week (in prefilled syringe) for 4 weeks (total 4 doses).~      Standard medical therapy included as per requirement lactulose, bowel wash, albumin,~     terlipressin, antibiotics (if indicated) will be continued and recorded. Pentoxiphylline in~     alcoholic hepatitis and Tenofovir in Hep B reactivation Controls: Standard medical therapy~     will be given along with placebo in similar prefilled syringes.~      Follow up Physical examination will be done daily, after 1 week and at 4 weeks, at 2 months,~     at 3 months and at 6 months CBC on alternate day for 1 week, at end of 1 week and then at end~     of 4 weeks , at 2 months, at 3 months and at 6 months~      KFT on alternate day for 1 week, at end of 1 week and then at end of 4 weeks, at 2 months, at~     3 months and at 6 months LFT along with PT/INR on alternate day for 1 week, at end of 1 week~     and then at end of 4 weeks, at 2 months, at 3 months and at 6 months AFP at baseline, after 4~     weeks, at 3 months and at 6 months Liver regenerative potential efficacy testing at baseline~     and after 4 weeks~   "
166722|NCT01383447|"~     This phase I/II trial is studying the side effects and best dose of entinostat when given~     together with imatinib mesylate and to see how well it works in treating patients with~     relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia.~     Entinostat and imatinib mesylate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth~   "
166723|NCT01383434|"~     Patients with severe, refractory aplastic anemia have a severe, life threatening disease in~     their bone marrow. Refractory disease means that disease has come back or not responded after~     receiving one or more immunosuppressive treatments. High dose chemotherapy followed by bone~     marrow transplantation (BMT) has been used to treat blood diseases like aplastic anemia but~     complications from Graft vs Host disease (GVHD) and graft failure have limited the survival~     for those patients.~      Another study done here at Johns Hopkins has shown that in patients with other diseases~     (blood cancers) some immunosuppressive drugs given after the BMT has decreased how often~     patients had complications of GVHD and engraftment failure.~      This research is being done to find if this approach will help patients with aplastic anemia~     who have failed other treatments will have better outcomes.~   "
166725|NCT01383408|"~     Previous studies have shown that specially trained sniffer dogs are capable to discriminate~     breath samples of patients with lung cancer and healthy individuals. So far it is not known~     whether this differentiation is specific for lung cancer or just identifies any form of~     (solid) tumor. Therefore, the dog's ability to differentiate between lung cancer, breast~     cancer and ovarian cancer is tested.~   "
166726|NCT01383395|"~     To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult~     subjects.~   "
166732|NCT01383317|"~     Remote Ischemic PreConditioning (RIPC) will improve the postoperative pain experience in~     patients undergoing abdominal surgery. Although abdominal surgery can be a lifesaving~     procedure many people have a significant amount of postsurgical pain. Severe postsurgical~     pain may lead to chronic pain in some people. Remote Ischemic Preconditioning may reduce~     the amount of postsurgical pain. Remote ischemic preconditioning is done by inflating a~     balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a~     few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to~     three times. This procedure causes the body to increase its natural pain relief system that~     may help to decrease the amount of postsurgical pain.~   "
166733|NCT01383304|"~     Previous studies indicate that patients with cardiovascular disease have a variable response~     to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial~     infarction. This has given rise to the phenomenon aspirin low-responsiveness. Laboratory~     aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet~     production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether a~     low platelet response to aspirin results in an increased risk of future thrombotic events is~     of great clinical significance, but is still unknown.~      The investigators hypothesize that patients with a reduced response to aspirin, determined by~     platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher~     risk of thrombosis.~      The purpose of this study is to investigate whether a higher incidence of cardiovascular~     events is found in patients with coronary artery disease (CAD) having a reduced biochemical~     response to aspirin compared with CAD patients having a normal biochemical response to~     aspirin. In addition to CAD, all patients have at least one of the following risc factors:~     previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.~   "
166734|NCT01383291|"~     -  Women who underwent mesh or sling procedures to correct pelvic organ prolapse will be~          enrolled.~        -  Their data will be collected from the files.~        -  Comparison between two groups will be carried our: Those who underwent a posterior IVS~          and those who underwent posterior prolift procedure.~        -  The data will be obtained by questionaires by a telephone interview by a physician who~          did not participate in the surgery.~        -  Follow-up physical examination data will also be obtained.~   "
166735|NCT01383278|"~     This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single~     session, computer-directed 5 A's intervention for smoking (experimental condition) to~     screening and resource provision (control condition). Follow-up visits will occur at 1 and 3~     months post study enrollment. Measures will focus on tobacco use and related psychosocial~     outcomes (e.g. mood, stress). We will compare resources used and economic costs needed to~     implement each intervention.~      The Investigators hypothesize that patients receiving the computer-directed intervention will~     have significantly higher tobacco abstinence rates at 3 months post study enrollment compared~     to the control group. If indeed the computerized intervention increases tobacco abstinence~     rates compared to the control group, this intervention could be used to increase access to~     treatment for the millions of US smokers, ultimately reducing tobacco mortality and morbidity~     rates in this country.~   "
166736|NCT01383265|"~     In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a~     dilute solution of Indigocarmine (IC) delivered by the water method (study method) will~     improve adenoma detection rate compared with the water method with plain water alone (control~     method).~   "
166737|NCT01383252|"~     In a prospective, randomized, controlled study, two methods (water method vs. air method) of~     performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC~     screening. The investigators hypothesize that:~        1. Study method increases overall cecal intubation with comparable assessment of current~          experience and patient willingness to repeat future colonoscopy compared with~          conventional colonoscopy~        2. Study method improves bowel preparation and increases polyp pickup rate~   "
166738|NCT01383239|"~     Rotator cuff tears are seen in 40% of subjects over age 50 57, with a prevalence known to~     increase with each decade of life 51. Each year rotator cuff disorders lead to 4.5 million~     physician visits, 40,000 inpatient surgeries, and 250,000 outpatient surgeries with costs of~     $17,427 per patient in 2004. As the population ages, the number of rotator cuff repair~     surgeries is increasing; in New York State, rotator cuff repairs increased by 50% over a 5~     years span 48. Unfortunately, surgically repaired rotator cuff tears fail in at least 20% and~     up to 94% of individuals 3, 9, 13, 20, 28, 40, 52, 58. While many non-modifiable variables~     have been associated with failure of repair, postoperative rehabilitation is a modifiable~     variable that has received little attention. The investigators propose a multicenter~     randomized controlled trial to study one important strategy for postoperative rehabilitation:~     early versus delayed onset of physical therapy. This pilot study will enroll patients with~     isolated supraspinatus tears who undergo a standard surgical repair technique. The~     investigators hypothesize that delaying the onset of physical therapy will improve healing~     and patient outcomes. Our primary outcome variable is the Western Ontario Rotator Cuff (WORC)~     Index (a disease specific validated outcome measure). Because outcome measures may not always~     correlate with healing of rotator cuff repairs 50, our secondary outcome measure will be~     healing based on MRI scans 12 months after surgery.~   "
166739|NCT01383226|"~     Patients are often referred for E(B)US examination and sampling of enlarged mediastinal~     and/or hilar lymph nodes that are not visible on a standard chest X-ray but are discovered by~     accident on CT scan performed outside the context of lung cancer or extrathoracic~     malignancies. Since CT scan is largely used and E(B)US is a minimally invasive technique,~     these cases are explored more frequently but so far nothing is known, however, on the~     prevalence of abnormal findings in EBUS sampling in this particular population and on the~     clinical implications (mainly therapeutical implications) of E(B)US findings.~   "
166740|NCT01383213|"~     The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2~     administration by a Venturi mask in terms of achievement of criteria for endotracheal~     intubation during severe acute respiratory failure caused by pneumonia~   "
166969|NCT01380236|"~     The purpose of the study is to determine the safety and tolerability of 8.0 mg of ASM8 when~     given daily for 14 days by the Aeroneb® Go nebulizer to subjects with moderate to severe~     asthma.~   "
166970|NCT01380223|"~     This study will assess the safety, tolerability, and pharmacodynamics of omecamtiv mecarbil~     infusion in healthy male volunteers.~   "
166741|NCT01383200|"~     In this study the investigators will be comparing two different types of anesthetic, a~     numbing eye drop and a numbing gel, to test if they are equally effective or if one has a~     better outcome in terms of the level of comfort you experience one hour and one day after~     your surgery. The two medications are commonly used and appear to be equally effective for~     other types of eye surgery, such as cataract surgery. This study will show if one type of~     anesthesia is preferred over another by patients getting LASIK. Before your LASIK procedure,~     you will be given a short questionnaire to determine the baseline comfort of your eyes. In~     the operating room, one type of anesthetic will be put in one eye, and the other medication~     will be put in the other eye. Which anesthetic you get in each eye will be chosen in a random~     way (similar to flipping a coin). After your LASIK surgery, the investigators will ask you if~     you felt more comfort in your right eye, your left eye, or if they were equal, and the~     investigators will ask you the same survey questions that were asked prior to your LASIK to~     get more details about your experience.~      *Of note- the randomization being done is for which eye will be receiving the lidocaine and~     which eye will be receiving the tetracaine. Each patient will receive lidocaine in 1 eye and~     tetracaine in the other eye, the randomization is for each individual eye. This means, of 11~     patients in our study, 22 eyes received treatment. 11 eyes received lidocaine and 11 eyes~     received tetracaine.~      when we did our comparison, 11 values were used for lidocaine and 11 eyes were used for~     tetracaine, giving a total of 22 eyes. This is important to note since the randomization~     refers to EYE for each individual patient, and not for the patient (ie: participant means 1~     eye, not 1 person in the descriptions below).~   "
166742|NCT01383187|"~     Deep skin burn injuries, especially extensive deep burns or/and deep burns extending on the~     face, hands, feet, genitalia and perineum, remain one of the most challenging therapeutic~     problems. Surgical excision of the necrotic burned tissue with subsequent skin grafting of~     the affected area has become the golden standard for the treatment of deep partial thickness~     and full thickness skin burns and represents the treatment of choice. Despite of all the~     progress achieved in the treatment process (artificial skin, cultured keratinocytes), the~     therapeutic results are sometimes unacceptable due to functional and cosmetic deficits~     causing severe psychological and emotional distress, particularly in the form of disfiguring~     and disabling scarring - i.e. hypertrophic scars, joint contractures restricted movement,~     peripheral neuropathy, psychiatric and physiological diseases, as well as thermoregulation~     disorders. Consequently, the quality of life is markedly decreased. That is why new methods~     of burn wounds covering are intensively searched. Based upon the results of available~     pre-clinical studies, the local use of autologous platelet concentrate with their active~     growth factors appears to be a good and promising possibility how to improve faster and~     higher quality of healing deep skin burn wounds.~   "
166743|NCT01383174|"~     The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn),~     improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina~     counselors who have had breast cancer provide support to recently diagnosed women. The~     investigators call these counselors peer support counselors.~   "
166744|NCT01383161|"~     This project is designed to study the effects of the dietary supplement curcumin on~     age-related cognitive impairment. In particular, the study seeks to determine the effects of~     curcumin on cognitive decline and the amount of abnormal amyloid protein in the brain.~     Genetic risk will also be studied as a potential predictor of cognitive decline.~      Subjects will be randomly assigned to one of two treatment groups: either a placebo twice~     daily or the curcumin supplement (Theracurmin®, containing 90 mg of curcumin). The~     investigators expect that the volunteers receiving the curcumin supplement will show less~     evidence of decline after 18 months than those receiving the placebo. The investigators~     predict that cognitive decline and treatment response will vary according to genetic risk for~     Alzheimer's.~      The investigators will study subjects with memory complaints aged 50-90 years. Initially,~     subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic~     risk and to rule out other neurodegenerative disorders linked to memory complaints.~     Subsequently, subjects will undergo an~     -(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)malononitrile (FDDNP) PET~     scan and a baseline neuropsychological assessment to confirm a diagnosis of MCI or normal~     aging. Once enrolled, subjects will begin taking the supplement (either curcumin or a~     placebo). Some of the initial subjects will be asked to return every three months for regular~     MRIs. Every 6 months, subjects will also receive neuropsychological assessments. At the~     conclusion of the study, subjects will be asked to complete a final neuropsychological~     assessment, MRI scan, PET scan and blood draw. Additional blood will be drawn at baseline and~     at 18 months and frozen to assess inflammatory markers if cognitive outcomes are positive.~      FDDNP-PET scans will be used to measure the amount of abnormal amyloid plaque- and tau~     tangle-proteins in the brain; the MRIs will be used to monitor supplement side effects and~     measure brain structure; the neuropsychological assessments will monitor rates of cognitive~     decline; the blood draws will be used to determine genetic risk and to test levels of~     inflammatory markers.~   "
166745|NCT01383148|"~     This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the~     efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV~     non-small cell lung cancer (NSCLC).~      TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain)~     carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has~     been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1~     antigen.~      TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a~     non-specific activation of several components of the immune system.~   "
166746|NCT01383135|"~     The purpose of the study is to conduct a pilot test of a new tracer in healthy human~     volunteers to define normal tracer biodistribution (where the tracer goes), stability (how~     much metabolises), pharmacokinetics (how much stays in which organs and for how long), and~     radiation dosimetry (organ radiation dose). The same radiopharmaceutical will then be tested~     in cancer patients.~   "
166747|NCT01383122|"~     Pain following Cesarean delivery remains the most common post-operative complaint, and the~     provision of effective and safe analgesia is very important. Pain can impede the mother's~     ability to mobilise, and to care for and breastfeed her newborn baby.~      Pulsed electromagnetic field (PEMF) devices have been used in various clinical settings,~     especially after plastic surgeries, to reduce postoperative swelling and pain, as well as to~     accelerate wound repair. PEMF therapy is simple to use, cost-effective and has no known side~     effects.~      Despite advances in post-operative analgesia, pain relief and maternal satisfaction remain~     inadequate in some patients. Improving the quality of post-Cesarean analgesia while limiting~     undesirable side effects will enhance maternal satisfaction and reduce the risk of~     post-operative complications.~      The investigators hypothesize that the continuous use of a PEMF device for 48 hours after~     Cesarean delivery will result in decreased post-operative pain scores on movement at 48~     hours.~   "
166748|NCT01383109|"~     The combination of pyronaridine and artesunate is an antimalarial therapy in development.~     This Mass Balance study is intended to determine the rate and extent of excretion of total~     radioactivity in urine and faeces following administration of a single oral micro-dose of~     14C-pyronaridine in humans.~   "
166749|NCT01383096|"~     This study is designed to assess prototype formulations compared to the aqueous dispersion of~     Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped~     that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that~     observed when given after food. This will improve the utility of OZ439 in the field as well~     as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very~     important for an antimalarial drug product destined for use in developing counties.~   "
166750|NCT01383083|"~     The prevalence of PAH associated with congenital systemic-to-pulmonary shunts in Western~     countries has been estimated to range between 1.6 and 12.5 cases per million adults, with~     25-50% of this population affected by Eisenmenger's syndrome. The rarity of this syndrome,~     combined with its complex pathophysiology, account for the insufficient understanding of the~     principles underlying its proper treatment.Recent decades have seen developments in pulmonary~     hypertension pathophysiology which have led to the introduction of new groups of drugs:~     prostacycline analogs (Epoprostenol, Treprostinil, Beraprost, Illoprost), phosphodiesterase~     inhibitors (Sildenafil, Tadalafil), endothelin receptor antagonists (Bosentan, Sitaxantan,~     Ambrisentan) and nitric oxide. These drugs should be administered to patients in III-IV NYHA~     class. Despite successful early results, the therapeutic effect on patients with Eisenmenger~     syndrome has not been conclusively established The treatment strategy for patients with PAH~     associated with congenital systemic-to-pulmonary shunts and, in particular, those with~     Eisenmenger's syndrome is based mainly on clinical experience rather than being evidence~     based. Although Eisenmenger's syndrome is uncurable disease, the survival rate is relatively~     higher than primary PAH, and the patients with Eisenmenger's syndrome are relatively younger~     group. So the improvement of exercise tolerance and quality of life is very important.~     Several randomized controlled trial reported favourable short- and long-term outcomes of~     treatment with the orally active dual endothelin receptor antagonist bosentan in patients~     with Eisenmenger's syndrome. However, there was scare data of outcomes of treatment with the~     inhaled iloprost in patients with Eisenmenger's syndrome. In Korea, most of patients with~     Eisenmenger's syndrome are treated with conservative therapy instead of administration of~     PAH-specific drug, because of lack of clinical experience. Moreover, oral agent such as~     bosentan, sidenafil is preferred than iloprost becase of more evidence and convenience. Our~     therapeutic efforts should be directed mainly towards preventing complications. As a rule, we~     should avoid agents with no established therapeutic efficacy and try to alleviate symptoms~     without any additional risk, so as not to disrupt the existing clinical balance.~      In this study, we investigate to know the clinical benefit of iloprost on patients with~     Eisenmenger's syndrome by the use of functional and hemodynamic parameters, which would add~     the evidence of PAH-specific agents on the Eisenmenger's syndrome~   "
166751|NCT01383070|"~     Primary hypotheses~      In a hospital-based CRCT, cell phone lactational counseling starting in the third trimester~     of pregnancy to 24 weeks after delivery will improve the prevalence of EBF by 7.5 % (7.5%~     increase in EBF by retraining in BFHI alone in both groups from baseline and a additional~     7.5% improvement in intervention group as compared to the control) compared with women with~     from hospitals with only retraining BFHI.~      Secondary hypotheses As compared to women from hospitals receiving only retraining in BFHI,~     those with additional cell phone lactational counseling will experience the following~        -  Increase in the percentage of EBF(breast milk and no other foods or milk based liquids)~          at 24 weeks after delivery,~        -  Increase in the mean duration of any breastfeeding,~        -  Increase in the percentage with TIBF,~        -  Reduction in use of pre lacteal feeds~        -  Reduction in percentage of infants being bottle fed(any liquid or semi-solid food from a~          bottle with nipple/teat) any time before or at 24 weeks~        -  Increase in the percentage of infants at 26 weeks after delivery who receive TICF,~        -  Increase in growth velocity (weight, length and head circumference)~        -  Reduction in the number hospitalizations or mortality in the mother-infant dyad till 26~          weeks after delivery~        -  Increase in adherence to visit schedules~        -  Greater ratio of effectiveness as compared to costs incurred for cell phone counseling.~   "
166752|NCT01383057|"~     The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to~     create a clear corneal incision during cataract surgery.~   "
166753|NCT01383044|"~     Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in~     prophylaxis of the first bleeding. The efficacy & safety of combining EVL and carvedilol in~     prophylaxis of the first bleeding is still unknown. This study aims to investigate the value~     of combination therapy.~   "
166754|NCT01383031|"~     The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic~     results of transumbilical laparoendoscopic single site cholecystectomy.~   "
166755|NCT01383018|"~     The purpose of this observational registry is to collect and better understand real-world~     outcomes for men undergoing penile implant surgery to treat erectile dysfunction.~   "
166756|NCT01383005|"~     Both twice-a-day (BID) and once-a-day (QD) dosing are approved in Europe for the protease~     inhibitor lopinavir/ritonavir (LPV/r; Kaletra®).~      Since once-a-day dosing is actually a driver for human immunodeficiency virus (HIV)-infected~     patients to request a specific antiretroviral, the aim of this study is to assess both~     patient's perception of and adherence to Kaletra once-a-day, as well as with which factors~     they are related.~   "
166757|NCT01382992|"~     EGFR mutations plays an essential role in EGFR-TKIs treatment. However, for some patients,~     tissue samples are not available. The purpose of this study is to determine whether blood~     sample is feasible for EGFR mutation detection.For late stage NSCLC, we hypothesis plasma~     sample is an alternative for detecting EGFR mutations.~   "
166758|NCT01382979|"~     The study examined whether an online course for college freshmen (AlcoholEdu) had an effect~     on alcohol misuse and related problems, using a randomized controlled design with 30~     universities.~   "
166759|NCT01382966|"~     Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans,~     was originally believed to be a non-classical Bone morphogenetic protein (BMP)~     antagonist.Sclerostin was recently identified as a component of parathyroid hormone (PTH)~     signal transduction.~      Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral~     metabolism.New advances in the pathogenesis of renal osteodystrophy (ROD) change the~     perspective from which many of its features and treatment are viewed. Calcium, phosphate,~     parathyroid hormone (PTH), and vitamin D have been shown to be important determinants of~     survival associated with kidney diseases. Now ROD dependent and independent of these factors~     is linked to survival more than just skeletal frailty.Furthermore, ROD is shown to be an~     underappreciated factor in the level of the serum phosphorus in CKD. The discovery and the~     elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the~     view of ROD.~      Emerging current data suggests a promising role for serum measurements of sclerostin in~     addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D patients~     (dialysis patients).~      Because of the close relationship between ROD and cardiovascular disease, the aim of this~     study is to investigate the association between sclerostin, arteriovenous fistula thrombosis,~     echocardiography and carpal tunnel syndrome in maintenance hemodialysis patients.~   "
166760|NCT01382953|"~     The purpose of this research is to simplify the standard recording system of the heart~     rhythm. The investigators desire to improve the ease of monitoring the cardiac rhythm for 24~     hours. The investigators intent is to use a very small, innovative monitoring patch system~     that relieves the patient of wearing a cumbersome and uncomfortable recording system. This~     research trial will carry the title The Simple ECG Monitoring for Comparison of a Sternal~     ECG Recording System with a Standard ECG Recording System for Holter Monitoring. The data~     from the investigational device is for comparative purposes only. It will not be used by~     medical personnel for study subject treatment or diagnostic purposes.~   "
166761|NCT01382940|"~     This study was designed to evaluate the safety of administering rituximab at a more rapid~     infusion rate in patients with moderate to severe rheumatoid arthritis who have had an~     inadequate response to biopharmaceuticals that treat diseases by interfering with tumor~     necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than~     eight weeks.~   "
166762|NCT01382927|"~     General anesthesia (GA) and paralysis are factors which facilitate atelectasis formation,~     especially in obese patients. Spontaneous breathing can reduce the amount of atelectasis. In~     this study, the investigators are comaparing obese patients undergoing hip arthroplasty in GA~     versus spinal anesthesia. Distribution of ventilation during and after anesthesia is assessed~     by eletrical impedance tomography (EIT).~   "
166763|NCT01382914|"~     The purpose of this study is to daily monitor the discoloration of teeth when participants~     rinse with a mouth rinse and black tea and to determine the time point when unacceptable~     discoloration occurs.~   "
166764|NCT01382901|"~     The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV)~     iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs~     Syndrome (RLS)~   "
166765|NCT01382888|"~     The primary objective of this study is to evaluate the effect of topically applied heparin in~     comparison to placebo on suitability of newly constructed primary arteriovenous fistulas in~     patients planned for haemodialysis at 7th week (± 1 week) after first study drug~     administration.~   "
166766|NCT01382875|"~     Fragility fractures are one of the commonest injuries among elderly people in Hong Kong and~     account for 12% of the disease burden in elderly aged 65 or above.~      A good management healthcare program and training helps elderly to restore full functional~     level and prevent re-fracture in the following 2 years after primary fracture, but Hong Kong~     lacks of such program. Some reports from other countries pointed out a well-organized~     multi-disciplinary management programs are cost-effective to identify and treat osteoporosis,~     reduce the fracture rate, improve quality of life and raise awareness of fragility fracture.~      This study aims to compare the cost-effectiveness of multi-disciplinary management program~     with conventional care controls. The clinical effectiveness outcomes (re-fracture rate, fall~     rate, mortality, mobility, quality of life and specialist follow-up time) of the fragility~     hip fracture patients in New Territories East receiving the proposed management program will~     be compared with those from Kowloon Central with usual care as controls. The findings will~     provide useful data for the policy maker to evaluate the current clinical service for~     fragility fracture patients and consider the implementation of new multi-disciplinary~     management program into our healthcare system.~   "
166767|NCT01382862|"~     The purpose of this prospective study in acute ischemic stroke patients is to compare~     alarm-to-needle time during randomly allocated periods with and without availability of a~     specially staffed ambulance equipped with computed tomography (CT) and point-of care~     diagnostics. The investigators hypothesize that compared to regular care the investigators~     will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke~     emergency mobile unit.~   "
166768|NCT01382849|"~     Florbetapir F 18 is an experimental radioactive drug that may allow doctors to image changes~     in the brain using a PET (Positron Emission Tomography) scanner. The purpose of this study is~     to evaluate the imaging characteristics of, Florbetapir F 18 (also known as 18F-AV-45) in~     patients who have previously undergone bleeding in their brains. Florbetapir F 18 binds to~     amyloid-ß peptide (Aß) that accumulates in the brains of patients with bleeding. These~     accumulations are called amyloid plaques and when extensive are labeled cerebral amyloid~     angiopathy (CAA). Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low~     level of gamma rays which can be detected by a PET camera.~      MRI detected microbleeds have been identified as markers of clinically silent hemorrhage from~     bleeding-prone vessels. Another imaging marker of vessel damage and risk of bleeding is the~     spot sign (SS). Finally, certain genetic signatures (ApoE genotype) have been shown to be~     associated with Aß deposition in the brain or predispose patients to higher risks of~     bleeding. This research study will explore the interactions of these factors and understand~     the physiology of intracerebral bleeding.~   "
166769|NCT01382836|"~     As part of ongoing efforts to determine the causes of asthma and the progression of the~     disease, this study will gather data to explore the interaction of genetic and environmental~     factors in the cause and severity of asthma in inner city children.~   "
166770|NCT01382823|"~     The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to~     create a clear corneal incision during cataract surgery.~   "
166771|NCT01382810|"~     The purpose of this study is to evaluate and compare the effects of Altaire Gel forming~     solution and Refresh Tears in mild-moderate dry eye patients.~   "
166772|NCT01382797|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37~     when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).~   "
166773|NCT01382784|"~     There is growing evidence that psoriasis is a systemic disorder which enhances~     atherosclerosis and the risk of cardiovascular disease. Epidemiological studies have shown an~     independent association between psoriasis and atherosclerosis, stroke and coronary artery~     disease. The main goal of this on-going study is to register data which will enable the~     identification of new markers of atherosclerosis activity and carotid plaque instability in~     patients with severe psoriasis.~   "
167129|NCT01378130|"~     Pathogenesis of central serous chorioretinopathy is not entirely understood yet, therefore~     further investigations are needed. During this study patients with an acute episode of~     central serous chorioretinopathy are observed with established ophthalmologic methods~     (multimodal imagine) every 6 weeks until subretinal fluid is reabsorbed to gain further~     insides in etiology, course and prognosis of this disease.~   "
166774|NCT01382771|"~     Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment~     and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who~     have failed conservative therapy including physical therapy, have had an initial >80% pain~     relief on a diagnostic medial branch block, and are scheduled to undergo a routine second~     medial branch block for facet mediated pain will be randomized. Both groups will receive the~     standard of care, a medial branch block. The treatment group will also receive one set of~     intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive~     intra-articular normal saline.~   "
166775|NCT01382758|"~     One in a hundred children is born with a heart defect. Some children require heart surgery~     within the first few days of life, while others can wait until they are older. A complication~     of open-heart surgery is low blood flow due to the heart-lung machine that can cause sudden~     loss of kidney function known as acute kidney injury (AKI). AKI causes complications that can~     increase hospital length of stay and increase risk of death. Current ways to identify AKI are~     not able to it until 2 or 3 days after it has occurred. Because of this, there is not a~     specific treatment for AKI. If the investigators diagnose AKI early, they might be able to~     treat it and improve outcomes in children. NIRS is a skin monitor that can detect low blood~     flow to the kidney and might help diagnose AKI when it occurs in the operating room. The use~     of NIRS to diagnose AKI early is the focus of this study.~   "
166776|NCT01382745|"~     The objective of this study is to demonstrate the feasibility of using Nimotuzumab and~     radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve~     a 65% local control rate with a better toxicity profile than the conventional treatment.~     Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this~     study.~   "
166777|NCT01382732|"~     Postpartum hemorrhage is an important cause of maternal morbidity and mortality. In patients~     with severe preeclampsia there is an increased risk of postpartum hemorrhage but the~     hemodynamic changes associated with this pathology make the management of any kind of~     bleeding particularly troublesome. There are many pharmacological options, being oxytocin the~     first line of treatment. However there is no evidence about the safety and efficacy of~     carbetocin, an oxytocin agonist. The investigators aimed to compare oxytocin with carbetocin~     for the routine prevention of postpartum hemorrhage in patients with severe preeclampsia.~   "
166778|NCT01382719|"~     This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of~     bremelanotide, administered subcutaneously on an as-needed basis under conditions of home~     use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire~     disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.~   "
166779|NCT01382706|"~     This phase II trial studies how well giving docetaxel and lapatinib ditosylate together as~     second-line therapy works in treating patients with stage IV bladder cancer that cannot be~     removed by surgery. Drugs used in chemotherapy, such as docetaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving docetaxel and lapatinib ditosylate together may kill~     more tumor cells.~   "
166780|NCT01382693|"~     This project, a small-scale pilot study, will attempt to determine if involvement in a~     group-based creative expression program may correlate with a reduction in use of psychotropic~     drugs for persons with dementia.~   "
166781|NCT01382680|"~     In ERCP practice, most often a combined use of guidewires is necessary to attain a~     therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a~     stricture to a nitinol wire for improved stability with the use of therapeutic devices. A new~     guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic tip.~     The investigators test the hypothesis that the use of this new guidewire would decrease~     number of guidewires used within one ERCP session.~   "
166782|NCT01382667|"~     The specific aim of the study is to investigate the relationship between the development of~     dyspepsia and GI dyspeptic symptoms in relation to circulating levels of peculiar GI peptides~     (such gastrin, pepsinogen and GLP-2) in patients with non-gastrointestinal neoplasm well~     controlled for emesis.~   "
166783|NCT01382654|"~     The objectives of this study were to:~        -  Examine the tolerability of two formulations and two dose concentrations of epinastine.~        -  Select formulation(s) of epinastine for future studies by evaluating the individual~          sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected~          after each study drug administration and the subject preference ranking assessed at the~          completion of the study.~        -  Compare the preference of two formulations and two dose concentrations of epinastine~          compared to azelastine following a single dose of each in a randomized, double-blind,~          two-cohort, three-period crossover design.~   "
166784|NCT01382641|"~     The doctors participating in this study are looking to show improved vision with the HOYA~     AF-1 aspheric intraocular lens after cataract surgery. They will also study the use of~     Revital Vision (neuro-sensory testing) in providing the highest potential for improved~     vision.~   "
166785|NCT01382628|"~     This is a pilot study examining tendon collagen, collagen cross-linking, and markers of~     tendon extracellular matrix metabolism in the Achilles tendon of diabetic patients with~     ulcerations and amputations of the lower extremity.~   "
166786|NCT01382615|"~     The purpose of this study is to collect a blood or bone marrow sample from patients with~     multiple myeloma and from volunteers without myeloma.~   "
166787|NCT01382602|"~     This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived~     Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary~     incontinence (SUI).~   "
166788|NCT01382589|"~     The purpose of this study is to determine whether afamelanotide and narrow band UVB are~     effective in the treatment of non-segmental vitiligo (NSV).~   "
166789|NCT01382576|"~     In the present study, serum chitotriosidase activity and its relationship with insulin~     resistance were determined in patients with Polycystic Ovary Syndrome (PCOS).~   "
166790|NCT01382563|"~     Develop Registry tool~   "
166791|NCT01382550|"~     The aim of this study is to estimate the incidence of spontaneous and provoked recurrent VTE~     and the bleeding events during a 10-year follow-up in subjects experiencing a first VTE~     stratified according to % AT levels and to treatment schedule (long-term vs 6-12 months oral~     anticoagulation+transient prophylaxis during high risk periods)~   "
166792|NCT01382537|"~     This study will focus on the efficacy of treating 80 patients who have functional limitations~     in activity because of chronic/recurrent neck or shoulder pain.~      Hypothesis 1: InterX therapy alone will have a moderate effect to reduce pain during weeks~     1-2.~      Hypothesis 2: Functional gains will be greater in patients receiving InterX therapy compared~     to those who received placebo treatment.~      Hypothesis 3: Chronic neck and shoulder pain is more prevalent in patients who exhibit~     radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.~   "
166793|NCT01382524|"~     Approximately 300 million short peripheral intravascular catheters (PIVs) were sold in the~     U.S. in 2009. These short (< 3 inches) peripherally inserted IV catheters are vital for~     providing patients with needed: 1) fluid, electrolyte, nutrient and blood product~     replacement, 2) medicines and 3) diagnostic solutions (dyes). However, these IV catheters~     have inherent risks or potential complications which may result from poor catheter securement~     or stabilization.~      When a PIV catheter is not properly secured, motion and micro-motion within the vessel cause~     injury to the vein. This damage to the vein is a primary cause of phlebitis, a distressing~     complication of PIV therapy. Additional complications of inadequate stabilization of the PIV~     catheter are infiltration, leaking at the insertion site, pain, infection and dislodgement.~     According to Royer (2003), the most common reason for PIV catheter failure is infiltration~     and dislodgement. Infiltration is more dependent on keeping the extremity still, where~     phlebitis is dependent on injuries due to the chemical nature of the drugs and fluids infused~     or by the physical trauma to the endothelium from IV pushes.~      The results of these complications are costly and can be serious if another vein cannot be~     immediately accessed or if the infiltrated infusate causes tissue necrosis. An unscheduled~     restart of another PIV catheter causes a delay in patient treatment, patient discomfort,~     patient dissatisfaction, safety concerns, nursing interruptions and additional costs. Actual~     costs associated with PIV catheter restarts include materials and nursing resources; yet~     intangibles such as, treatment for patient complications and patient dissatisfaction may be~     far more costly.~      One way to reduce the incidence of PIV catheter-associated complications is to use~     technologies that help reduce catheter movement thereby improving catheter stabilization. In~     addition to stabilization platforms added to the peripheral IV catheter design, catheter~     stabilization devices and modified transparent film dressings also help to reduce catheter~     movement and could possibly eliminate the need for routine catheter site changes.~      Therefore, the purpose of this study is to: 1) compare the number of PIV securement-related~     complications and PIV catheter restarts of one stabilization system to another stabilization~     system and 2) to determine which system provides a cost savings.~   "
166794|NCT01382511|"~     Simvastatin and related statins, such as compactin, are able to inhibit the constitutive~     expression of inducible/repressible keratin genes such as K6a and K17. This effect is due to~     the reported ability of statins to inhibit STAT1 expression (Lee et al., 2007). The~     constitutive K6a promoter activity is dependent on STAT1 and blocked by simvastatin or siRNA~     against STAT1. This STAT1-dependent constitutive expression of K6a, is independent of JAK~     (Janus family of kinases).~      Thus simvastatin is capable of down-regulating both the constitutive and interferon-inducible~     expression of PC-related keratins such as K6a and K17. Therefore, this class of molecule has~     potential for the treatment of PC or related inherited disorders where the causative mutation~     resides in an inducible/repressible keratin gene such as K6a or K17.~      Simvastatin or other statins approved for human use might be delivered either orally, as is~     currently the case for cholesterol-lowering treatment or, if higher therapeutic doses are~     required in skin for reduction of hyperkeratosis in PC or in related keratinizing disorders,~     this might be achieved by topical formulations.~   "
166795|NCT01382498|"~     Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2~     diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of~     diabetic retinopathy showing a slowdown of the progression of the disease after long-term~     oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent~     vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the~     failure of autoregulation that it is an important and often early feature of diabetic~     retinopathy.several studies have been confirmed that inflammation besides oxidative stress~     are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in~     detecting inflammation in these patients. The aim of this study was to determine the effects~     of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.~   "
166796|NCT01382485|"~     The specific question the investigators will seek to answer is: can the Reamer Irrigator~     Aspirator (RIA) provide a bone graft source for the treatment of nonunions that is equally~     effective to Autogenous Iliac Crest Bone Graft (AICBG) while resulting in a decreased amount~     of post-operative pain and a lower rate of complications?~   "
166797|NCT01382472|"~     In this mechanistic pilot study in 40 patients the investigators will compare the findings in~     patients treated with very early high dose statin therapy with historic controls from the~     KOMPIS study published in EHJ 200925. The investigators want to assess if early high dose~     statin therapy in patients treated with primary PCI:~        1. reduces area of myocardial infarction, reduces volumes and improves remodelling as~          assessed by MRI at 2 days and at 2 months~        2. improves microcirculation (Decreased number of patients with MO) as assessed by first~          pass time estimated with MRI 2 days~        3. have impact on coronary blood flow as assessed by intravascular registrations and TIMI~          frame count immediately after PCI~        4. reduce levels of CK-MB and TnT measured as area under the curve during the hospital stay~          at improves neurohumoral profile assessed by Heart Rate Variability (HRV) and~          neurohormones at discharge and at 2 months follow-up~        5. improves endothelial function assessed by flow mediated vasodilatation at discharge~        6. alters Peak VO2 at 1 and 6 month~        7. reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at~          follow-up alters collagen turnover~   "
166798|NCT01382459|"~     The investigators assume that an intervention program that includes home visits and trainings~     of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic~     balance, a decrease in complications' rate, a reduction of hospitalizations and an economic~     streamlining.~   "
166799|NCT01382446|"~     Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol~     for trauma patients on ventilator support to decrease the incidence of Ventilator Associated~     Pneumonia and oral bacterial load.~   "
166825|NCT01382108|"~     The purpose of this study is to look at both the meibomian glands and the tear film using a~     new clinical instrument marketed in Canada which was recently acquired by the Centre for~     Contact Lens Research. These will be compared between two groups of individuals, one group~     with visible meibomian gland dysfunction (MGD) and one group of individuals with normal~     meibomian gland appearance. The hypothesis is that there will be a difference between normal~     individuals and individuals with MGD with respect to the appearance of the meibomian glands~     and certain tear film attributes.~   "
166826|NCT01382095|"~     The purpose of the study is to determine if immunization with a recombinant E. coli protein,~     dscCfaE, is safe and immunogenic when administered through the skin using a patch.~   "
166800|NCT01382433|"~     The aim of the current study is set out to find a human model for negative symptoms based on~     clinical observation that chronic cannabis users express negative symptoms and characterize~     by the same neurocognitive and electrophysiology characteristics like patient suffer from~     schizophrenia. Towards that end the first part of the study is set out to explore weather~     chronic cannabis user's express negative symptoms similar to patient suffer from~     schizophrenia. The second part of the study will explore the neurocognitive and~     electrophysiology characteristics of those cannabis users that express negative symptoms.~     This data will be compared to parallel data of schizophrenia patients with predominantly~     negative symptom.~      Several lines of biological and genetic evidence support the cannabinoid hypothesis for~     schizophrenia. Particularly, it is most significant clinically that the possible involvement~     of the cannabinoid system in the neural basis for the negative symptoms. This hypothesis~     based on clinical findings that chronic cannabis use causes a combination of symptoms~     including apathy, avolition, lack of interest, passivity, and cognitive impairments, the~     so-called amotivational syndrome, which resembles the core negative symptoms of~     schizophrenia in behavioral level as well as the brain level. Both are associated with the~     functions or integrity of the frontal lobe due to its role in creating self-directed~     behaviors, deficits in which may underlie alogia, anhedonia, and flat affect. Despite the~     aforementioned similarities, to date, there is no documentation for such a relationship.~     Recognition that chronic cannabis users share the same or similar constellation of symptoms~     and similar neurocognitive and electrophysiology characteristics could provide a key to~     develop a human model for negative symptoms and an essential tool to comprehensive~     understanding of the etiology of negative symptoms and development of an innovative therapy.~      The investigators Hypothesize That Chronic Cannabis Users Would Express the Same~     Constellation of Behaviors as Negative Symptoms of Schizophrenia; as well as similar~     neurocognitive and electrophysiology characteristics~   "
166801|NCT01382420|"~     Objective:~      To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of~     adrenal incidentaloma.~      Methods:~      234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two~     groups(e.g adrenalectomy group and conservative treatment group).~   "
166802|NCT01382407|"~     The hypothesis of this study is that patients who suffered from acne vulgaris during~     adolescence are at greater risk of developing acneiform skin rash due to cetuximab.~   "
166803|NCT01382394|"~     Brain natriuretic peptide (BNP) is involved in the regulation of blood pressure and fluid~     volume. It is used for the early diagnosis of heart failure (HF) in patients presenting to~     the emergency room with dyspnea. Interleukin-6 (IL-6) is a cytokine marker of inflammation~     that exhibits significant prognostic value in predicting severity and outcome of sepsis.~     Recently, it was suggested that inflammatory cytokines play an important role in the~     development of heart failure. Procalcitonin (PCT) is a propeptide of calcitonin which is~     normally produced in the C-cells of the thyroid glands. Although physiologic levels of PCT~     remain very low, a dramatic increase in serum PCT levels is observed during severe systemic~     infections. These properties make procalcitonin less useful for the diagnosis of simple~     infections but a very promising marker of severe infections especially in the critical care~     setting.~      To investigate the co-relation between BNP, IL-6 and procalcitonin in two groups of patients;~     those presenting with the diagnosis of decompensated heart failure and in patients presenting~     with the diagnosis of sepsis without cardiovascular or hemodynamic dysfunction.~   "
166804|NCT01382381|"~     The goal of the study is to evaluate long term durability and hemodynamic effect of implanted~     stents in the aortic arch and in pulmonary artery branches.~   "
166805|NCT01382368|"~     -  Pulmonary diseases are increasingly important causes of morbidity and mortality in the~          modern world.~        -  Sildenafil, an orally administered a phosphodiesterase type 5 (PDE-5) inhibitor, targets~          the nitric oxide (NO) pathway. The drug was first approved for the treatment of~          Pulmonary Arterial Hypertension (PAH) in 2005.~        -  The aim of the suggested study is to examine the acute effect of oral intake of~          sildenafil on exercise tolerance and functional capacity in Chronic Obstructive~          Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis (IPF) and post Pneumonectomy~          patients.~        -  The investigators hypothesize that oral ingestion of sildenafil prior the exercise may~          enhance exercise tolerance and improve function in COPD, IPF and post Pneumonectomy~          patients.~        -  Patients and Methods:~      Sixty chronic lung disease patients males and females (aged 30 to 90 years) 20 COPD (GOLD~     III-IV) [9, 39] , 20 IPF and 20 post Pneumonectomy patients will be recruit to this study.~        -  All subjects will carried out two maximal cardiopulmonary exercise tests (CPET) on~          bicycle ergometer in different days; 60 min after intake of placebo and 60 min after~          intake of 100 mg sildenafil (Pfizer, Sandwich, UK), in random order.~        -  In first meeting prior exercise test at rest standard pulmonary function test, diffusion~          of CO, TLC and RV will be measured. In addition, Doppler Echocardiography and blood~          samples for NT-proBNP will be taken prior and post each CPET.~        -  After 15-20 minute of passive recovery post exercise test all patients will perform 3~          short functional tests including 6 minute walk test to assess functional capacity.~   "
166806|NCT01382355|"~     Advances in transplant pharmacotherapy have led to improved one-year patient and graft~     survival in kidney transplant recipients, but have not translated to enhanced long-term~     survival. An explanation for the disparity in outcomes is the negative role of antibodies in~     transplant graft survival. There currently does not exist maintenance immunosuppression that~     targets antibodies and standard of practice aims at removing circulating donor specific~     antibodies upon detection of antibody mediated graft damage but not prior to the detection of~     rejection. There exists an insufficiency of data regarding patient and donor characteristics,~     changes in immunosuppression, the risk of viral donor and patient seropositivity and the risk~     of non-compliance on the development of antibodies. By measuring antibody levels in the blood~     at specific time periods after transplant, we may have a better understanding of what types~     of patients will develop antibodies, when these antibodies appear and how changes to~     transplant medications may affect antibodies.~      The proposed project will examine the multifactorial risks associated with the development~     and appearance of donor-specific antibodies in the first year post-kidney transplant. The~     data collected will provide a historical perspective and preliminary pilot data to support a~     proposal for prospective antibody monitoring and to justify pre-emptively treating the~     antibodies in the absence of clinical signs of rejection.~   "
166827|NCT01382082|"~     Cognitive impairments in cancer patients represent an important clinical problem. Studies to~     date estimating prevalence of difficulties in memory, executive function, and attention~     deficits have been limited by small sample sizes and many have lacked healthy control groups.~     More information is needed on promising biomarkers and allelic variants that may help to~     determine the etiology of impairment, identify those most vulnerable to impairment, and~     develop interventions for these difficulties.~      This is a longitudinal observational study of cognitive function in breast cancer and~     lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive~     difficulties (i.e., problems with memory, executive function, and attention) in these~     populations.~   "
166807|NCT01382342|"~     While Parkinson's disease has historically been defined in terms of its motor symptomatology,~     studies have shown that non-motor deficits form an important part of the syndrome. Cognitive~     deficits can occur even in the early stages of Parkinson's disease. These deficits are often~     subtle and do not rise to the level of impairment necessary for a diagnosis of dementia;~     however these deficits are discernable with neuropsychological testing and may produce~     subjective complaints of cognitive decline and mild functional difficulties in some patients.~     The traditional pharmacological interventions for Parkinson's disease have focused on~     controlling and alleviating motor symptoms with levodopa and dopamine agonists. However,~     these medications treat the symptoms of PD, but do not alter the course or progression of the~     underlying disorder. In contrast, rasagiline, an MAO-B inhibitor, has recently shown benefits~     consistent with a possible disease-modifying effect. Given the positive and intriguing~     findings seen with treatment with rasagiline, the investigators propose to study the effects~     of this medication on cognition in patients with mild to moderate stage Parkinson's disease.~      Hypotheses:~        1. Rasagiline will improve cognitive function, as measured by performance on~          neuropsychological tests in PD patients who do not suffer from dementia.~        2. Rasagiline will not negatively affect neuropsychiatric functioning.~   "
166808|NCT01382329|"~     The purpose of this study is to obtain immunogenicity and safety data of two different dose~     levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18~     to 59 years.~   "
166809|NCT01382316|"~     This study tests the effectiveness of Making Alcoholics Anonymous Easier (MAAEZ), a~     manual-guided intervention designed to help alcohol and drug dependent clients connect with~     individuals encountered in AA. An OFF/ON design was used (n=508). MAAEZ effectiveness was~     determined by comparing abstinence rates of participants recruited during ON (MAAEZ~     intervention) and OFF (usual care) conditions and by studying the effect of the number of~     MAAEZ sessions attended. Better outcomes were hypothesized for MAAEZ vs. usual care. At 12~     months, more clients in the ON condition (vs. OFF) reported past 30-day abstinence from~     alcohol, drugs, and both alcohol and drugs. Abstinence increased for each additional MAAEZ~     session received. MAAEZ appeared especially effective for those with more prior AA exposure,~     severe psychiatric problems, and atheists/agnostics. Mechanisms of action for MAAEZ~     (mediators of the MAAEZ effect) include: doing service in AA/NA/CA; having a sponsor; having~     a social network supportive of abstinence; and comfort being in meetings. MAAEZ represents an~     evidence-based intervention that is easily implemented in existing treatment programs.~   "
166810|NCT01382303|"~     This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline~     on proteinuria in Korean type 2 diabetic patients.~   "
166811|NCT01382290|"~     Diffusion-weighted (DW) magnetic resonance imaging (MRI) imaging is a well established method~     for detecting acute injury to the brain and is used on all children undergoing an MRI brain~     scan at Children's Healthcare of Atlanta. The possibility of using DW MRI to study other~     areas of the body, such as the spinal cord, has been recognised as having great clinical~     potential. However, two main problems have hindered the clinical application of the~     technique; firstly, the extreme motion sensitivity of the technique meant that respiratory~     motion have hampered clinical studies. Secondly, the close proximity of the spinal cord to~     the bones in the spinal column complicates the application of the techniques developed for~     the brain to the spine. Recently, several techniques have been developed which address these~     problems and these are now available on the MRI scanners used at Children's Healthcare of~     Atlanta.~      We now wish to evaluate how well these techniques work on children in a routine clinical~     setting. For this reason we wish to add a single scan of the spine to the imaging protocol of~     children receiving a routine scan of the brain or spine. This will permit us to evaluate the~     image quality in both normal and abnormal spines. We plan on enrolling 60 patients with~     normal spines and 30 patients with abnormal spines. No additional sedation and/or contrast~     will be required and the additional imaging time for the diffusion studies will be less than~     10 minutes. Parental consent will be a pre-requisite for any patient to be enrolled into the~     study.~   "
166812|NCT01382277|"~     This multicentre, open-label, single-arm Study is to evaluate the effect of Rosuvastatin 20~     mg 76 weeks on coronary atherosclerosis plaque versus baseline in Chinese coronary heart~     disease (CHD) patients with hyperlipidemia by measuring the plaque volume using a 64 slice~     spiral CT. Effect on blood lipids, hsCRP and Carotid intima-media thickness (CIMT) is also~     evaluated.~   "
166813|NCT01382264|"~     The primary purpose of this study is to determine whether the use of a computer assisted~     decision support (CADS)system by primary care providers (PCPs) for their patients with type 2~     diabetes mellitus (T2DM) changes the quality of care relative to a usual care group in~     terms of objective outcome measures of glycemic control (e.g., A1C, mean blood glucose,~     frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.~   "
166814|NCT01382251|"~     The purpose of this study is to assess the functional recovery of older ambulatory surgical~     patients and the impact of the current model of care on the caregivers of these patients.~     This study will provide unique insight into the challenges patients and their families face~     following surgery.~      The primary objective of this study is to:~        1. Assess the impact of ambulatory surgery on functional capacity as assessed by the~          Système de Mesure de l'Autonomie Fonctionnelle (SMAF) one week and one month following~          surgery in a population of surgical patients 65 years of age and older.~           Secondary objectives are to determine if:~        2. Changes in the patient's functional capacity result in increased burden of care as~          assessed by the Zarit Burden Interview (ZBI) in the patient's primary caregiver.~        3. Changes in functional capacity are correlated with decrements in quality of life as~          assessed by the Short Form 12 (SF12).~        4. Changes in functional capacity are correlated with inadequate postoperative analgesia as~          assessed by the Brief Pain Inventory (BPI).~   "
166828|NCT01382069|"~     The long term objective is to develop a new male hormone Dimethandrolone Undecanoate (DMAU)~     as a male hormonal contraceptive.~      The study has two parts. The first is a dose escalating study in healthy to assess the safety~     and tolerability of single dose oral administration of DMAUin healthy men.(Completed)~      The second is to study the safety and tolerability of DMAU after 28 days of repeated daily~     dosing of DMAU in healthy men. (Currently Recruiting) In both parts the investigators will~     also study the pharmacokinetics of Dimethandrolone (DMA) in the serum after oral~     administration of DMAU.~   "
166815|NCT01382238|"~     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials~     for the treatment of human immunodeficiency virus (HIV) infection. A granule formulation has~     been developed as an alternative to the current tablet formulation for administration in~     pediatric populations.~      This is a single-center, randomized, open-label, 5-way crossover study in healthy adult~     subjects. The study will evaluate the relative bioavailability of a 50 mg granule formulation~     of dolutegravir when administered 1) directly to mouth; 2) with purified water; 3) with~     Contrex brand water; and 4) with milk-based infant formula compared to the current 50 mg~     tablet formulation administered with tap water. Safety evaluations and serial PK samples will~     be collected during each treatment period. A taste assessment of the granule will also be~     performed. A follow-up visit will occur 5-7 days after the last dose of study drug.~      Pharmacokinetic assessments during the study will include area under the concentration-time~     curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), area under~     the concentration-time curve from time zero (pre-dose) to last time of quantifiable~     concentration within a subject across all treatments (AUC(0-t)), maximum observed~     concentration (Cmax), terminal phase half-life (t½), lag time before observation of drug~     concentrations in sampled matrix (tlag), time of occurrence of Cmax (tmax), concentration at~     24 hours post-dose (C24), and apparent clearance following oral dosing (CL/F).~   "
166816|NCT01382225|"~     The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in~     treating the signs and symptoms of dry eye disease.~   "
166817|NCT01382212|"~     The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages~     10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal~     dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will~     be in the dosing period of the study for 12 weeks in order to evaluate the incidence of~     hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and~     all 12 will receive paricalcitol capsules.~   "
166818|NCT01382199|"~     The purpose of the study is to Evaluate the Efficacy and Safety of Recombinant Human~     Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult~     Patients.~   "
166819|NCT01382186|"~     Deployment of Secure Messaging (SM) in primary care and women's clinics throughout the~     Veteran Health System by 2011 was an implementation priority for the Secretary and Under~     Secretary for Health for FY11 under the VHA T21 initiative. Secure Messaging is in early~     phases of implementation, this eHealth tool requires thoughtful evaluation to promote the~     successful implementation and dissemination of this tool. The primary aim of this project is~     to describe Veterans' experiences when using the SM feature on MyHealtheVet (MHV). This~     project has local, VISN, and national impact on the implementation and sustainability of the~     SM feature on MHV through its qualitative and quantitative examination of users' experiences.~     Findings from this research explores why Veterans choose to, or not to, use the SM feature on~     MHV, identify facilitators and barriers, and examine if experiences differ by health literacy~     or computer literacy. In addition to the interview data, findings from the usability testing~     and the quantitative survey findings build knowledge about Veterans' experiences using the SM~     feature on MyHealtheVet. These data will inform systems improvements, educational approaches,~     and marketing strategies to increase adoption and long-term utilization among Veterans.~   "
166820|NCT01382173|"~     Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes,~     the overall aim of this study is to investigate structural injuries and biochemical~     alterations in the acutely injured knee and to relate these findings to clinical outcomes at~     various time points.~   "
166821|NCT01382160|"~     Adalimumab is a fully human monoclonal antibody to tumor necrosis factor-alpha (TNF-α)~     approved in rheumatoid arthritis (RA) refractory to disease modifying anti rheumatic drugs~     (DMARDs) and for the treatment of severe, active and progressive RA in adults not previously~     treated with methotrexate.~      However, almost one third of patients have no response and approximately 15% develop~     antibodies towards adalimumab (ATA) after a 6 month course of treatment. There is a~     relationship between adalimumab concentration and clinical response obtained after 6 month of~     treatment. Furthermore adalimumab concentration measured 3 months after initiation seems to~     predict the clinical response at 6 months.~      There is an important inter individual pharmacokinetic variability of adalimumab. Side~     effects may occur at the recommended dose and more than 3 months of treatment are generally~     required to estimate the clinical response.~      A therapeutic drug monitoring could help clinicians to early adjust the dose to optimize the~     response and to avoid dose related side effects. To date there is no definite adalimumab~     target concentration predictive of the clinical response to allow such a pharmacologic~     monitoring.~   "
166822|NCT01382147|"~     Evaluation weather early chemotherapy attempts for remission induction can improve the~     results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.~   "
166823|NCT01382134|"~     Study hypothesis: Desmopressin (DDAVP) can improve platelet function under influence of~     aspirin, hemodilution and mild hypothermia~      Mild hypothermia (34-35oC) is known to cause platelet dysfunction. This could lead to~     increased surgical bleeding and increased transfusion requirement during surgery. Although~     this hypothermia-induced platelet dysfunction seems to be reversible with warming, this is~     not always possible or desirable.~      Desmopressin (DDAVP) is a drug which has proven efficacy in improving platelet function in~     uraemic and cirrhosis patients, and in reducing blood loss in selected surgeries. In a recent~     study, we have found that subcutaneous injection of 1.5 mcg (1/10th the usual dose) is~     already sufficient to fully reverse the platelet dysfunction seen at 32oC. We have~     demonstrated in another study that prolongation of the bleeding time in a 20% hemodiluted~     sample predicts increased postoperative bleeding after total knee replacement.~      We have therefore designed this study as a follow up to our last two studies on DDAVP and~     hypothermia, to investigate whether hemodilution affects hypothermia induced platelet~     dysfunction and the response to DDAVP. In addition, another common cause of perioperative~     platelet dysfunction is the intake of COX inhibitors, particularly aspirin by patients.~     Therefor the effect of aspirin on hypothermia induced platelet dysfunction and the response~     to DDAVP, will also be investigated.~   "
166824|NCT01382121|"~     The purpose of this study is to implement a peer modeling intervention to improve~     self-efficacy and aerobic fitness in obese youth. A total of 40 obese (defined as Body Mass~     Index greater than the 95th percentile for age and gender) youth will participate in this~     study.~   "
166830|NCT01382043|"~     The safety and efficacy of drug-eluting stents (DES) with a biocompatible polymer have been~     demonstrated in randomized clinical trials as well as in real world practice. Theoretically,~     a new DES with a biodegradable polymer should reduce the incidence of late in-stent~     thrombosis, however, the long-term safety and efficacy of these stents remains unknown. This~     study was aimed to compare the safety and efficacy of the Excel DES with a biodegradable~     polymer to the Endeavor DES with a biocompatible polymer in same individuals.~   "
166831|NCT01382030|"~     Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic~     control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide,~     ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An~     additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed~     by MRI and CT scans and FDG-PET in a subgroup of patients.~   "
166832|NCT01382017|"~     This study has been designed to explore dose-depended effects of lacosamide (LCM) on motor~     cortex excitability with TMS in a randomized, double-blind, placebo-controlled crossover~     trial in young healthy human subjects, and to compare the pattern of excitability changes~     induced by LCM with those of carbamazepine (CBZ). LCM selectively enhances slow inactivation~     of voltage-gated sodium channel, and, in contrast to CBZ, does not affect steady-state fast~     inactivation (Errington et al., 2006). The enhancement of slow inactivation of sodium~     channels by LCM is a novel manner to modulate sodium channels and leads to normalization of~     activation thresholds and a reduced pathophysiological hyper-responsiveness, thereby~     effectively controlling neuronal hyperexcitability without affecting physiological activity~     (Beyreuther et al., 2007). Therefore, it is thought that LCM, compared to CBZ, will be better~     tolerated in clinical settings while being as or even more effective in controlling seizure~     activity. On the basis of the results from nonhuman studies, it is hypothesized that the TMS~     profile of LCM will be distinguishable from that of CBZ. CBZ, like other 'classical' sodium~     channel blockers such as phenytoin, predominantly demonstrated elevated TMS motor thresholds~     indicating reduced neuronal membrane excitability, without developing significant changes of~     synaptic intracortical inhibition and facilitation (Ziemann et al., 1996; Chen et al., 1997;~     Lee et al., 2005). Because of its novel mode of action it can only be speculated which TMS~     parameters LCM might affect. For example, more than exclusively affecting neuronal membrane~     excitability, LCM could possibly also affect inhibitory mechanisms such as short- and~     long-latency intracortical inhibition (Valls-Sole et al., 1992; Kujirai et al., 1993). This~     would in line with other well-tolerated modern antiepileptic drugs (Ziemann et al., 1996;~     Reis et al., 2002; Lang et al., 2006).~   "
166833|NCT01382004|"~     Yaws, an endemic treponematosis and as such a neglected tropical disease (NTD), is currently~     making a comeback in children in rural areas. Injectable long acting penicillin remains the~     drug of choice for the treatment of yaws. However, on the basis of successful experience with~     venereal syphilis in large-scale studies, oral azithromycin has emerged as a potential~     alternative that overcomes the major medical and logistic disadvantages of the current~     regimen.~      In this non-inferiority randomized clinical trial the investigators propose a comparable~     scheme for the treatment of yaws, to test the efficacy of a single, oral dose of azithromycin~     versus a single, i.m. dose of benzathine penicillin G.Sample size has been calculated to~     detect a non-inferiority margin of 10%. Children < 15 years of age with a confirmed diagnosis~     of yaws will be randomly assigned to receive 30mg/Kg (maximum 2g) of azithromycin orally or~     50.000units/Kg (maximum 2.4MU) of penicillin-G-benzathine intramuscularly. The primary~     outcome is treatment efficacy, with cure defined serologically (a decline in the VDRL titer~     of at least two dilutions by six months after treatment) and, in primary yaws, also by~     epithelialization of ulcers within two weeks.~   "
166834|NCT01381991|"~     Endoscopy is a widely used modality for the diagnosis and classification of Gastroesophageal~     reflux disease (GERD), and the extent of esophageal mucosal breaks on endoscopy can be~     assessed. However, there were some limitation in diagnosis of GERD using endoscopy~        1. More than half of patients with GERD reveal no visible abnormality on conventional~          endoscopy, it is possible that minute mucosal changes are underestimated by conventional~          endoscopy due to the limitation of visual ability~        2. In addition of uncertainty in detecting mucosal breaks, uncertainty in describing~          severity of mucosal injury can lead to inconsistency among interpreters. Interobserver~          agreement regarding diagnosis and classification of GERD using endoscopy is~          unsatisfactory to apply daily practice.~      Thus, the development of a new method to define the intra-esophageal injury for use in daily~     practice is a worthwhile endeavor and developed, such as narrow−band imaging (NBI), Fuji~     Intelligent Chromoen−doscopy (FICE) and i-scan.~      Among them, i-scan technology is the most recently developed image enhancing technology,~     which consists of three modes of image enhancement, i.e. surface enhancement (SE), contrast~     enhancement (CE), and tone enhancement (TE).~      Thus, the investigators examined the hypothesis that i-scan can improve the detection rate of~     reflux esophagitis and inter-observer agreement between endoscopists compared with~     conventional white light (WL) endoscopic examination.~   "
166835|NCT01381978|"~     Hypothesis: Obesity in children of Cuenca is related with socioeconomical status and physical~     activity habits.~      Summary:~      The prevalence of obesity and overweigh in all age groups are increasing rapidly in the~     world. Some factors like physical activity, socioeconomical status, dietary habits, gender,~     besides genetic factors influence in the development of obesity.~      In Cuenca - Ecuador lack information related to prevalence of overweight and obesity in~     children and the risk factors related.~      Socioeconomical status and quality of physical activity are assessed using specially designed~     questionnaires in a randomized sample of children 6 to 9 years of age of Cuenca city.~     Nutritional status is assessed using body mass index, relation weight/age and height/age.~     These data are helpful to develop programs focused to improve nutritional status in scholars~     of Cuenca.~   "
166836|NCT01381965|"~     Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the~     repair of photoreceptor cone outer segment tips defect is significantly correlated with the~     visual outcomes after macular hole surgery.~   "
166837|NCT01381952|"~     ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise~     reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose~     significantly. This is realized by anatomy-specific optimization of the full acquisition~     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing~     engine) for every clinical task individually. Furthermore, smaller focal spot sizes and~     shorter pulses are used, which are known to positively influence image quality . The final~     effect on the clinical image quality is investigated in this study.~   "
167330|NCT01375465|"~     The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary~     intervention (PCI) to assess the clinical success, efficacy and safety of the~     Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial~     bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat the~     stenotic site branch.~   "
166838|NCT01381939|"~     Induction of Labour in Intrahepatic Cholestasis of Pregnancy (ICP) has become a common~     procedure in management of ICP to avoid fetal complications. Surprisingly, this empirical~     approach has not been evaluated as to delivery complications and fetal outcome as yet. The~     investigators now examine weather ICP affects (i) delivery procedures chosen, in particular~     the incidence of caesarian section, (ii)fetal and maternal outcome in induced labor, and~     (iii)possible impact of bile acids and UDCA treatment in a retrospective cohort study based~     on approximately 5000 induced deliveries at Danderyd Hospital, Karolinska Institutet,~     Stockholm. The investigators analyze data on on previous deliveries, BMI, medical history and~     medical book data. Primary endpoint is the risk of caesarian section.~   "
166839|NCT01381926|"~     The purpose of this study is to determine changes in bone turnover markers and calcitonin~     following the initiation of exenatide compared to placebo in postmenopausal women wtih type 2~     diabetes.~      Hypothesis 1a: Bone resorption (measured by osteocalcin and bone-specific alkaline~     phosphatase) will be lower and bone formation (measured by type I collagen crosslinked~     aminoterminal peptide in urine (Urine NTX)) will be higher when subjects are treated with~     exenatide compared to when subjects are treated with placebo.~      Hypothesis 1b: Calcitonin levels will not vary significantly between periods of treatment~     with exenatide vs. placebo.~   "
166840|NCT01381913|"~     Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor~     prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed~     in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor~     control compared with NAC. This feasibility trial explored the feasibility and safety of~     neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.~   "
166841|NCT01381900|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of the addition~     of canagliflozin relative to the addition of placebo in patients with inadequate glycemic~     control on metformin alone or in combination with a sulphonylurea.~   "
166842|NCT01381887|"~     The purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose~     blood levels in patients with Type 2 Diabetes Mellitus.~   "
166843|NCT01381874|"~     The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate~     plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane,~     each compared with oral exemestane alone, in postmenopausal women with estrogen~     receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after~     treatment with letrozole or anastrozole.~   "
166844|NCT01381861|"~     The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with~     recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.~   "
166845|NCT01381848|"~     The purpose of this study is to measure drug levels of doripenem in blood samples collected~     before and after administration of doripenem to infants less than 12 weeks of age who are~     hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and~     are undergoing treatment with intravenous (i.v.) antibiotics. Safety and tolerability will~     also be assessed.~   "
166846|NCT01381835|"~     The purpose of this study is to assess the steady-state pharmacokinetics of TMC435 in~     participants with severe renal impairment and to compare these with the TMC435~     pharmacokinetics in matched participants with normal renal function. We will also study the~     short-term safety and tolerability of TMC435, when administered in participants with severe~     renal impairment and in participants with normal renal function. Steady-state is a term that~     means that the drug has been given long enough so that the plasma concentrations will remain~     the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic~     hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into~     the bloodstream, distributed in the body, and eliminated from the body.~   "
166847|NCT01381822|"~     The primary objectives are:~      Dose escalation:~      1. To determine the MTD and DLT(s) of TH-302 when used in combination with sunitinib.~      Dose expansion:~        1. To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib~          as determined by the response rate and the progression-free survival in subjects with~          advanced RCC treated at the RP2D~        2. To assess the safety of TH-302 in combination with sunitinib and determine a recommended~          Phase 2 dose of the combination.~      The secondary objectives are:~      Dose expansion:~      1. To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib~     as determined by stable disease or better rate, duration of response and overall survival in~     subjects with advanced RCC treated at the RP2D.~      The exploratory objective is:~      1. To explore the association of serum hypoxia biomarkers with efficacy endpoints.~   "
166848|NCT01381809|"~     The purpose of this study is to demonstrate that epoetin alfa works better than placebo in~     improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of~     epoetin alfa will also be evaluated.~   "
166849|NCT01381796|"~     The purpose of this research is to:~        1. Compare two study patches having minor differences in patch components~        2. Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates~          medication) of NP101 (study patches) versus a currently approved oral formulation of~          Imitrex~        3. Collect resistance data during application of NP101 (study patch)~   "
166850|NCT01381783|"~     The purpose of this study is to determine if topical anesthesia is safe for~     phacoemulsification in eyes with comorbidities.~   "
166851|NCT01381770|"~     The purpose of this study is to demonstrate that platelet-derived repairing factors are~     effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label,~     single arm, single centre has been designed. Sample size will be 25.~   "
166943|NCT01380574|"~     The purpose of this study is to investigate the complications of cardioversion of acute (<48~     hours duration) atrial fibrillation (AF).~      Primary Outcome Measures:~      - Incidence and predictors of thromboembolic complications, especially stroke, and death <31~     days after cardioversion of acute AF~      Secondary Outcome Measures:~        -  Number of therapy non-responder and early recurrence of AF~        -  Bleeding complications during the 31 days follow-up~        -  Hemodynamic complications of cardioversion~      Estimated Enrollment: 3000 cases~      Study Start Date: Jun 2011~      Estimated Study Completion Date: December 2011~   "
166944|NCT01380561|"~     This is an open label, single center, metabolite identification, mass balance, and PK study~     in healthy male volunteers.~   "
166852|NCT01381757|"~     Background:~      -Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed~     with a test that is fast and inexpensive but not always accurate. The purpose of this study~     is to test a new method for diagnosing TB, called the microscopic-observation~     drug-susceptibility (MODS) test. The MODS test takes 7 days to show results. The test also~     gives information on which drugs will work best in each case.~      Objective:~      -To test a new method for diagnosing tuberculosis called the microscopic observation drug~     susceptibility test.~      Eligibility:~        -  Participants must be 12 years of age or older.~        -  They must have a diagnosis of TB from a sputum smear, or have symptoms of TB and an~          x-ray indicating that TB is present.~      Design:~        -  Participants will take part in the study from 6 months to 21 months and be assigned to~          one of three groups, depending on what type of TB they have.~        -  At the first visit, researchers ask questions about general health and symptoms of TB.~          They check vital signs, draw blood, and ask for a sputum sample. The blood is used to~          check for HIV infection and for the number of CD4 cells, which measures the severity of~          the HIV infection.~        -  The 2-, 5-, and 6-month visits are similar to the first. Those who do not have~          multidrug-resistant (MDR) TB will end their participation after the 6-month visit. MDR~          TB is tuberculosis that has not responded to isoniazid and rifampicin. Participants with~          MDR TB will remain in the study for 21 months.~        -  No treatment is provided as part of this study.~   "
166853|NCT01381744|"~     Plague is an infectious disease of animals and humans caused by bacteria, Yersinia pestis.~     Modern antibiotics are effective against plague, but if an infected person is not treated~     promptly the disease is likely to cause illness or death. The purpose of this study is to~     evaluate at the safety, immunogenicity (bodily defense reaction), and tolerability of a new~     research vaccine. Up to 48 people will be enrolled in this study at the Center for Vaccine~     Development at Saint Louis University. Four groups of 12 volunteers will be given vaccine or~     placebo (inactive substance) one group at a time starting with the lowest dose working up to~     the highest dose. Shots will be given in the arm 2 times separated by 28 days. Study~     procedures include: physical exam, blood samples, and recording temperature and side effects~     in a memory aid. Participants will be involved in study related procedures for about 13~     months.~   "
166854|NCT01381731|"~     The objectives of this trial are to:~        -  Assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus~          placebo following one week of treatment in subjects undergoing photorefractive~          keratectomy (PRK).~        -  Evaluate the potential of diquafosol to accelerate corneal wound~          healing/re-epithelialization following PRK.~   "
166855|NCT01381718|"~     RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer~     treatment.~      PURPOSE: This phase II randomized trial studies how well modafinil works in treating children~     with memory and attention problems caused by cancer treatment for a brain tumor.~   "
166856|NCT01381705|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how well patients will respond~     to treatment.~      PURPOSE: This research study is studying biomarkers in predicting response to rituximab~     treatment in samples from patients with indolent follicular lymphoma.~   "
166857|NCT01381692|"~     This randomized phase I/II trial studies the side effects and the best dose of temsirolimus~     when given together with bortezomib, rituximab, and dexamethasone and to see how well they~     work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with~     untreated or relapsed Waldenstrom macroglobulinemia or relapsed or refractory mantle cell or~     follicular lymphoma. Bortezomib and temsirolimus may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of~     cancer cells by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab,~     can block cancer growth in difference ways. Some block the ability of cancer cells to grow~     and spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. It is~     not yet known whether bortezomib, rituximab, and dexamethasone are more effective with~     temsirolimus in treating non-Hodgkin lymphoma.~   "
166858|NCT01381679|"~     This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol~     Screening and Treatment project (ACT I), which assessed the cholesterol status, including~     achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in~     participants with coronary heart disease (CHD) already being treated with a statin. In this~     study, participants without adequate LDL-cholesterol reduction with a statin underwent~     extension of therapy with ezetimibe with the goal of achieving target levels.~   "
166859|NCT01381666|"~     The objective of the present work is to explore and compare the diagnostic quality of sputum~     specimens obtained by BAL, induction with hypertonic saline (3%), and induction with INS316~     in patients diagnosed with interstitial lung diseases.~   "
166860|NCT01381653|"~     An existing face-to-face HIV prevention intervention (The Young Men's Health Project, YMHP;~     R01DA20366) will be iteratively adapted and pilot-tested to target difficult to engage~     high-risk young men who have sex with men (YMSM) via online social networking and aims to~     reduce both high-risk sexual behavior and drug use.~   "
166861|NCT01381640|"~     This is a single dose pharmacoscintigraphic study investigating the differences in~     paracetamol absorption between two formulations.~   "
166945|NCT01380548|"~     This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in~     subjects with iron deficiency anemia.~   "
166946|NCT01380535|"~     The purpose of this study is to evaluate the safety and effectiveness of extracorporeal~     photopheresis therapy when added to standard drug therapies administered to patients with~     moderate to severe chronic graft-versus-host disease.~   "
166947|NCT01380522|"~     The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D.~     Searle, Inc.~   "
166948|NCT01380509|"~     The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D.~     Searle, Inc.~   "
166949|NCT01380496|"~     The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen~     doxycycline monohydrate 100 mg.~   "
166862|NCT01381627|"~     Lung cancer is the second most commonly diagnosed primary neoplasia in Canada accounting for~     22 865 new cases in 2007. Recent randomized trials have shown a significantly better~     diagnostic yield and fewer unnecessary thoracotomies with endobronchial ultrasound-guided~     transbronchial needle aspiration (EBUS-TBNA) when compared to conventional TBNA for various~     clinical conditions including peripheral pulmonary lesions and sarcoidosis. EBUS-TBNA are now~     routinely performed in our institution for staging of pulmonary and mediastinal cancer.~     EBUS-TBNA are performed under monitored anesthesia care (MAC) in the endoscopy suite at the~     Centre de soins ambulatoires of the Hôpital Maisonneuve-Rosemont.~      Remifentanil, used in combined regime or as single agent proved to be effective and safe for~     MAC. Nonetheless, anesthesiologists are still confronted to the respiratory depression~     profile of remifentanil and other commonly used agents. An analysis of the ASA Closed Claims~     demonstrated that respiratory depression remains a significant drawback during MAC in remote~     locations. Furthermore, patients with coexisting pulmonary diseases scheduled for EBUS-TBNA~     are at increased risk of such complications.~      The investigators hypothesize that compared to the use of remifentanil-based MAC protocol,~     the use of dexmedetomidine-based MAC protocol for EBUS-TBNA will result in a lower incidence~     of major respiratory and hemodynamic adverse events (bradypnea, apnea, oxygen desaturation,~     hypotension, hypertension, bradycardia and tachycardia) with equivalent overall procedure~     conditions.~   "
166863|NCT01381614|"~     Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom~     burden is limited in commercially insured patients (age >= 18 years and < 65 years).~     Additionally, limited information exists on economic burden of adverse events associated with~     treatments for advanced/metastatic renal cell carcinoma. An objective of the current study is~     to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic~     RCC in a US real-world setting. Another objective is to quantify the economic burden of~     severe adverse events with agents used in management of first line advanced/metastatic RCC~     (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective~     cohort design. Analyses of health insurance claims data from a large commercially insured~     population will be employed in the current study. Study subjects will consist of all persons,~     aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009;~     these persons will be identified based in part on case-ascertainment algorithms. Analyses~     will be directed at estimating annual rates of incidence and prevalence of~     advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events~     associated with treatments used in management of advanced/metastatic RCC (sunitinib,~     sorafenib, bevacizumab, and pazopanib).~   "
166864|NCT01381601|"~     Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom~     burden is limited in commercially insured adult patients. Additionally, limited information~     exists on economic burden of adverse events associated with treatments for~     advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate~     the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US~     real-world setting. Another objective is to quantify the economic burden of severe adverse~     events with agents used in management of first line advanced/metastatic RCC (sunitinib,~     sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective cohort design.~     Analyses of health insurance claims data from a large commercially insured population will be~     employed in the current study. Study subjects will consist of all persons, aged ≥18 years,~     with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons~     will be identified based in part on case-ascertainment algorithms. Analyses will be directed~     at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as~     symptom burden and costs of common severe adverse events associated with treatments used in~     management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).~   "
166865|NCT01381588|"~     This is an observational study to investigate the prevalence of osteoporotic fractures in~     post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including~     GHs(general hospitals) and clinics will be enrolled.~   "
166866|NCT01381575|"~     This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals'~     HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and~     0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule~     (0,1,6 months) in 15-25 year old females.~   "
166867|NCT01381562|"~     This study is being conducted to evaluate the safety, efficacy and~     pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal~     infections. GSK2251052 will be compared to meropenem, an IV therapy that is approved for use~     in the treatment of subjects with cIAI. GSK2251052 has a spectrum of microbiological activity~     that includes pathogens responsible for cIAI.~   "
166868|NCT01381549|"~     This study is being conducted to evaluate the safety, efficacy (clinical and~     microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it~     would be a suitable antibiotic for the treatment for febrile lower cUTI and~     pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to~     imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections.~     GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for~     cUTI.~   "
166869|NCT01381536|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus~     (SLE).~   "
166950|NCT01380483|"~     The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen~     doxycycline monohydrate, 100 mg.~   "
166951|NCT01380470|"~     The purpose of this study is determine the prevalence of undiagnosed Chronic Obstructive~     Pulmonary Disease (COPD) in population served and with exposure to cigarettes in the Region~     of Murcia~   "
166952|NCT01380457|"~     The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg~     capsules verses Marinol.~   "
166953|NCT01380444|"~     The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus~     sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52~     weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery~     rates, fracture healing rates, fracture related adverse events, and health-related quality of~     life, including the Parker mobility score and Harris Hip Score.~   "
166870|NCT01381523|"~     The goal of this study is to measure medical resource utilization, treatment patterns, and~     costs for 1.) triptan-naïve patients with new pharmacy claims for a combination treatment of~     sumatriptan and naproxen sodium (SumaRT/Nap) or single-entity triptan and 2.) patients who~     are switched from one triptan to either SumaRT/Nap or a different single-entity triptan. The~     analysis will compare the mean number of prescription tablets used (including triptans,~     NSAIDs, opioids, and ergots) and migraine-specific medical resource utilization/costs and~     pharmacy costs incurred by health plan members who switched to SumaRT/Nap from a~     single-entity triptan. The null hypothesis for the triptan-naïve analysis is that no~     difference will be observed between resource utilization and costs incurred by patients~     treated with SumaRT/Nap and those treated with a single-entity triptan. The test hypothesis~     is that one group will incur significantly fewer costs and/or significantly lower health care~     utilization. For the triptan switch analysis, the null hypothesis is that no difference will~     be observed in the costs or health care utilization between triptan patients who are switched~     to SumaRT/Nap compared with those switched to a new triptan. The test hypothesis is that one~     treatment group will experience significantly lower costs and/or lower health care~     utilization.~      The source of data for this analysis is the Lifelink Health Plan Claims Database (owned by~     IMS Health, Inc). This claims database includes more than 60 million covered lives. In~     addition to inpatient and outpatient records, this database includes standard and mail-order~     pharmacy claims with paid and charged amounts and dates of service.~      Data from July 1, 2008 to December 31, 2009 (study period) will be used to conduct these~     retrospective analyses. Patients with at least one pharmacy claim for SumaRT/Nap between~     January 1, 2009 and June 30, 2009 (enrollment period) will be identified. The date of the~     first SumaRT/Nap pharmacy claim will be the index date for those patients. Each patient will~     be propensity score matched with an oral triptan patient based on the following pre-index~     covariates: age; gender; payer; geographic region; average monthly number of tablets of~     triptans, NSAIDs, and opioids; and average number of hospitalizations, emergency department~     visits, and physician visits in the month immediately preceding the index date as well as the~     mean number of hospitalizations, emergency department visits, and physician visits in the~     5-month pre-index period. SumaRT/Nap patients and their single-entity matched controls who~     had no pharmacy claims for triptans prior to the index date will be analyzed in the triptan~     naïve group, and the SumaRT/Nap patients and their single-entity matched controls who~     switched to a new triptan will be analyzed in the switch analysis.~   "
166871|NCT01381510|"~     Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be~     associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health~     care costs.~      The objective of this retrospective database analysis is to quantify the relationship between~     adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention~     (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic~     hyperplasia (BPH). The study will also measure the economic impact associated with these~     medical encounters.~      The MarketScan database contains data from people with commercial health insurance and~     Medicare and includes both medical and pharmacy data that are sourced directly from health~     plans and employers. Approximately 18 million covered lives will be utilized for this study~     in the time period from January 1, 2003 to September 30, 2009.~      This study is a retrospective cohort analysis of medical claims data.~   "
166872|NCT01381497|"~     Migraine headaches lead to absenteeism and can restrict on-the-job productivity~     (presenteeism) for employed migraine sufferers. Effective migraine treatments should reduce~     migraine-associated productivity losses and return migraineurs to normal functioning within a~     few hours of treatment.~      This study is an observational, multicenter, parallel-group study of employed patients who~     have been prescribed either a combination product containing sumatriptan and naproxen sodium~     (SumaRT/Nap) or oral triptan monotherapy to treat acute migraine attacks. The study will~     report results from 4 migraine attacks per patient. Eligible migraine attacks will be defined~     as those preceded by a 24-hour, headache-free period with onset between 2 hours prior to the~     start of and 4 hours before the end of a scheduled work shift. Data will be collected at time~     of treatment and hourly until the end of the attack or the end of the workday. To estimate~     baseline productivity, data will be collected from 50 randomly selected subjects during a~     migraine-free workday.~      The primary objective of this study is to compare migraine-related, work productivity losses~     (absenteeism and presenteeism) reported by patients treated with SumaRT/Nap to losses~     reported by patients treated with triptan monotherapy. The null hypothesis is that no~     difference will be observed between the number of hours of productivity lost for patients who~     treat workday migraine attacks with SumaRT/Nap and patients who treat migraine attacks with~     an oral triptan alone. The alternative hypotheses are that patients in either treatment group~     experience significantly fewer hours of lost productivity associated with migraine compared~     to patients in the other treatment group.~      The secondary objectives of this study are to measure the time between treatment and return~     to patient-reported, normal functioning; to evaluate rescue medication use after initial~     treatment; to measure total productivity loss following treatment at hourly time points; and~     to estimate the probability of absenteeism when a migraine begins before or during the~     workday. The null hypotheses for the secondary endpoints are that no differences will be~     observed between the results reported by patients treating with SumaRT/Nap and patients~     treating with triptan monotherapy. The alternative hypotheses are that either treatment is~     superior to the other for each endpoint.~   "
166873|NCT01381484|"~     The purpose of this study is to determine whether La Jolie gel is effective in the treatment~     of periorbital wrinkles.~   "
166874|NCT01381471|"~     The specific aim of this study is to describe 1 year Advair dispensing rates for patients~     with COPD, and to measure the association between Advair adherence and healthcare utilization~     (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD~     exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat~     are adherent versus those that are not.~   "
166875|NCT01381458|"~     This retrospective database study will assess differences in the risk of re-hospitalization~     and other COPD-related exacerbations and costs for patients receiving fluticasone~     propionate/salmeterol xinafoate combination 250/50 (FSC) versus anticholinergics [i.e.~     tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred~     to as ipratropium - IPR)] post-hospitalization or Emergency Department (ED) visit for the~     treatment of COPD.~      This is a hypotheses testing study. Associations are compared between FSC and AC cohorts.~      Hypotheses for the primary outcome and key secondary outcomes are presented below:~      Specifically the study hypotheses for the primary outcome being tested were:~      Ho: There is no difference in risk of COPD-related hospitalization between FSC and AC Ha:~     There is a difference in risk of COPD-related hospitalization between FSC and AC~      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:~      Ho: There is no difference in COPD-related costs between FSC and AC Ha: There is a difference~     in COPD-related costs between FSC and AC~   "
166876|NCT01381445|"~     This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to~     explore the potential for skin thinning in healthy adult volunteers after 42±2 days of~     treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086~     2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or~     clobetasol propionate 0.05% cream.~   "
166877|NCT01381432|"~     This post-marketing surveillance study is to investigate the efficacy and safety of~     azathioprine tablets in subjects whom lung transplantation is performed.~   "
166878|NCT01381419|"~     This study described in the present protocol consists of two sections. Part A is the first~     administration into man to evaluate the safety, tolerability and pharmacokinetics of single~     ascending doses of GSK1144814. The study is a single-blind, randomised, placebo-controlled~     design in healthy male and female (of non-childbearing potential) subjects. Part B will be an~     open-label design in healthy male subjects to assess the GSK1144814 neurokinin-1 (NK1)~     receptor occupancy by positron emission tomography (PET) scanning with [11C]-GR205171~   "
166954|NCT01380431|"~     The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets~     and IPR Pharmaceuticals, Inc. Zestril (R).~   "
167218|NCT01376934|"~     Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine~     cavity and investigate of abnormal uterine bleeding . The success of the procedure is based~     on the distension of the cavity . It can cause pain and discomfort and sometimes the~     procedure fails. . There are two techniques to make the procedure , one with gas and the~     other with saline solution. Objective: to compare two techniques concerning pain , procedure~     duration and image quality~   "
166879|NCT01381406|"~     This was a retrospective cohort design using administrative claims data from Jan 1, 2003~     through Sep 30, 2007, representing the years of available data, were used for this study.~     Managed care enrollees having at least one pharmacy claim for tiotropium (TIO) during the~     study period were identified as the target population. An index TIO prescription was defined~     as the first chronologically occurring pharmacy claim for TIO during the period Jan 1, 2004~     to Aug 31, 2006, called the enrollment period. The date of the index TIO prescription was~     termed as the index Rx date, and the 1-year period before the index Rx date was termed as the~     pre-index period. The period after the index date was termed as the post-index date, and is~     further divided into a 30-day combination assessment period and a 1-year follow-up period.~     COPD clinical and economic outcomes were measured in a variable length follow up period.~      The combination assessment period, defined as the 30-day period following the index Rx date,~     was used to categorize patients into 2 cohorts: TIO alone or TIO + FSC (fluticasone~     propionate/salmeterol xinofoate combination) depending on whether they use FSC in combination~     with TIO during this period. Combination therapy with TIO + FSC was defined as having an FSC~     claim on the same date as the TIO claim or a TIO and FSC pharmacy claim with overlapping days~     supply occurring within 30 days of index Rx date. Enrollees adding FSC for the first time~     after the 30-day combination assessment period were excluded from the sample, thus ensuring~     that the TIO-alone cohort is not using FSC. No outcomes were assessed in the 30-day~     combination assessment period. The 1-year period after the end of the 30-day combination~     assessment period was termed as the follow-up period and was used to assess all study~     outcomes. Enrollees were required to be continuously eligible in their health plans during~     the pre-index and post-index periods for a total of 25 months. An intent-to-treat approach~     was used for the analyses. Thus, patients identified to be in a drug therapy cohort were~     considered to be using that therapy during the entire follow-up period, regardless of therapy~     discontinuations.~      Specifically the study hypothesis for the primary outcome being tested was:~      Ho: There is no difference in risk of any COPD-related exacerbation between TIO+FSC and TIO~     cohorts Ha: There is a difference in risk of any COPD-related exacerbation between TIO+FSC~     and TIO cohorts~      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:~      Ho: There is no difference in COPD-related costs between TIO+FSC and TIO cohorts Ha: There is~     a difference in COPD-related costs between TIO+FSC and TIO cohorts~   "
166880|NCT01381393|"~     This is an open label, multi-centre, non-interventional post-marketing surveillance.~   "
166881|NCT01381380|"~     This study is a pain intensity evaluation in patients with myofascial pain submitted~     kinesitherapy after trigger point injection.~   "
166882|NCT01381367|"~     Streptococcus pneumoniae is the most common causes of community-acquired pneumonia and~     exacerbations in chronic obstructive pulmonary disease (COPD) patients, which are associated~     with morbidity, mortality, and higher health-care cost. In addition, recently high daily dose~     of inhaled corticosteroid (ICS) therapy became more evident to be beneficial in~     moderate-to-severe COPD patients, but excess risk of pneumonia shown in database analysis was~     worried about by primary physicians. The use of pneumococcal polysaccharide vaccination~     (PPSV23) has protective efficacy to eliminate infection of Streptococcus pneumoniae from~     previous studies. If the use of PPSV23 can reduce the incidence of pneumonia or exacerbations~     in COPD patients using high daily dose of ICS, the benefit of ICS can be preserved and risk~     of pneumonia can be reduced. However, there is only limited data supporting this hypothesis.~     In this study, the investigators will conduct a double-blinded, randomized controlled trial~     to evaluate the clinical efficacy of PPSV23 in severe COPD patients using high daily dose of~     ICS.~   "
166883|NCT01381354|"~     The study will use a multimodal therapeutic lifestyle intervention consisting of a study~     diet, stressing more vegetables and fruit, elimination of foods at greatest risk for food~     allergy, meditation, self massage, progressive exercise and neuromuscular electrical~     stimulation for rehabilitation of gait and fatigue disability in the setting of secondary and~     primary progressive multiple sclerosis with gait disability.~   "
166884|NCT01381341|"~     A pharmacokinetic study to compare 2 clinical formulations of linifanib.~   "
166885|NCT01381328|"~     The purpose of this study is to correlate the different patterns of resistance mutations~     observed in vivo in patients failing RAL treatment with the fold-change resistance determined~     by the phenotypic assay.~   "
166886|NCT01381315|"~     It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic~     drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk~     for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node~     dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of~     the breast during the procedure would potentially decrease the incidence of arm lymphatic~     disruption and subsequent development of lymphedema while providing adequate axillary breast~     nodes needed for staging.~   "
166887|NCT01381302|"~     The study population will include 100 parkinsonian patients in early stage of disease, with~     total duration not exeeding 5 years.~      The patients will undergo neurologic examination and evaluation of disease severity using the~     unified PD rating scale. Subsequently a brain SPECT will be performed using Tc-99m-Trodat1.~   "
166888|NCT01381289|"~     The purpose of this expanded access program is to provide VX-770 prior to its commercial~     availability to people with cystic fibrosis (CF) who have at least one copy of the G551D-CFTR~     mutation and who are in critical medical need and who are not eligible for participation in~     other Vertex-sponsored studies.~   "
166889|NCT01381276|"~     The purpose of this study is to determine the vitamin A equivalents in high-carotenoid~     varieties of cassava.~   "
166890|NCT01381263|"~     Recurrent pain, such as headache, stomach pain and musculoskeletal pain is common in children~     and adolescents. Children and adolescents are reported to have restrictions in daily life~     activities, social contacts, and school attendance, and to have poorer academic skills and as~     well as an increased utilization of heath care services due to pain problems. The treatment~     approaches available today for teenagers with pain are often biological/physiological and~     little evidence for their effectiveness has been shown. It is urgent to try new interventions~     for pain problems in early ages in order to prevent disability, development of maladaptive~     coping strategies and to avoid negative impact on daily activities.~      The optimal treatment regime for paediatric pain patients has been suggested to be cognitive~     behavioural approach integrated with physical therapy The aim of this project is to develop~     and evaluate in a randomized controlled trial a treatment program with a behavioural medicine~     approach (suitable to use in primary care or school based health care context) compared with~     standard treatment for adolescents with persistent pain problems. The aim is also to compare~     short and long-term costs for patients and for the health care system related to the two~     interventions, in order to determine strategies for future cost-effective care of children~     and adolescents experiencing recurrent pain.~   "
166891|NCT01381250|"~     A trial testing the outcome of an Internet-based treatment of pathological gambling with the~     hypothesis that there will be improvements both immediately and up to 36 months. It is also~     hypnotized that treatment response can be predicted from background variables.~   "
166966|NCT01380275|"~     The purpose of this study is to estimate the control rate (CR,PR,SD) of docetaxel and~     irinotecan (DI) combination chemotherapy for recurrent or refractory bone and soft tissue~     sarcomas.Al so, this study is to evaluate the toxicity profile of Docetaxel and Irinotecan~     (DI) combination chemotherapy.~   "
167331|NCT01375452|"~     The purpose of this study is to compare bioavailability in healthy, post menopausal women~     subjects under fasting conditions.~   "
166892|NCT01381237|"~     Due to the many problems associated with reduced balance and mobility, providing an effective~     and engaging rehabilitation regimen is essential to progress recovery from impairments and to~     help prevent further degradation of motor skills. The purpose was to examine effects of~     physical therapy based on the task-oriented approach delivered in an engaging, interactive~     video game paradigm. The intervention focused on performing targeted dynamic tasks, which~     included reactive balance controls and environmental interaction. Thirty community dwelling~     and ambulatory older adults attending the Day hospital for balance and mobility limitation~     treatment participated in this study. Participants were randomly assigned to either a control~     group or experimental group. The control group received the typical rehabilitation program~     provided at the Day Hospital, consisting of strengthening and balance exercises. The~     experimental group received a program of dynamic balance exercises coupled to video game~     play, using a centre of pressure (COP) position signal as the computer mouse. The tasks were~     performed while standing on a fixed floor surface with progression to a compliant sponge pad.~     Each group received 16 sessions, scheduled two per week, each lasting 45 minutes. Balance~     performance measures and spatial-temporal gait variables were obtained pre- and~     post-treatment Findings demonstrated significant improvements for both groups in balance~     performance scores post-treatment, and change scores were significantly greater in the~     experimental compared to control group. No significant treatment effect was observed in~     either group for the spatial-temporal gait variables. In conclusion dynamic balance exercises~     on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based~     exercise. This in turn resulted in a greater improvement in dynamic standing balance control~     compared to the typical exercise program. However there was no transfer of effect to gait~     function.~      Key Words: Balance, Postural; Rehabilitation; Therapy, computer-assisted; Video Games; Center~     of Pressure.~   "
166893|NCT01381224|"~     The purpose of this project is to determine the effect of lower back injections on select~     biomechanical outcomes, walking patterns, lower back flexibility and balance.~   "
166894|NCT01381211|"~     Hepatocellular carcinoma (HCC) is a primary malignant tumor of the liver that accounts for an~     important health problem worldwide. In only 10% - 15% of all patients with HCC, tumors are~     considered resectable at presentation. In contrast to metastatic liver disease, there is no~     role for systemic chemotherapy in the treatment of HCC. Today only evidence is available for~     Sorafenib, a tyrosine kinase inhibiting agent. The arsenal of non-surgical therapies can~     roughly be divided into local ablative, transarterial and systemic therapies. In well~     selected patients, local ablative therapy can offer favorable long term results.~      For patients with disease confined to the liver, but locally more advanced, transarterial~     treatment modalities are proposed. These therapies exploit the dual blood supply to the~     liver. HCC derives its blood supply almost entirely from the hepatic artery, while liver~     parenchyma derives > 75% of its blood supply from the portal vein. Antitumoral agents, such~     as cytotoxic drugs or radionuclides, can be delivered in close proximity of the tumor.~      Examples of transarterial therapies are: transarterial chemoembolization (TACE), bland~     transarterial embolization (TAE), transarterial chemoembolization with drug eluting beads~     (TACE-DEB) and transarterial radioembolization with Iodine-131 or Yttrium-90.~      TACE is currently the gold standard for treatment of patients with intermediate stage HCC,~     with a reported median survival of around 17 months. A novel development in the TACE~     treatment for HCC is the drug-eluting bead (DEB). Recently performed small clinical trials~     reported the efficacy of DEBs in the treatment of intermediate stage HCC, which is~     substantially higher compared to conventional TACE.~      Yttrium-90 radioembolization (90Y-RE) is a relatively recently developed technique which~     implements transarterial administration of minimally embolic microspheres loaded with~     Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.~      In this study the investigators want to prospectively compare TACE-DEB and 90Y-RE, two novel~     treatments that both have theoretical and/or proven advantages compared to the use of~     conventional TACE, in patients with intermediate stage HCC.~   "
166895|NCT01381198|"~     The purpose of this study is to evaluate the effects of an additional distal rectus femoris~     transfer carried out as a part of single-event multilevel surgery in children with spastic~     diplegic cerebral palsy.~   "
166896|NCT01381185|"~     The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet~     therapy to golden standard (Light transmittance aggregometry-LTA) in high risk population of~     acute myocardial infarction patients. If two methods (PFA-100, VerifyNOW,Multiplate or LTA)~     will indicate insufficient antiplatelet blockade/high residual reactivity for aspirin,~     clopidogrel or both, the dose of aspirin will be increased to 200mg qd and the dose of~     clopidogrel will be increased to 2x75mg qd.In addition genotyping of CYP2C19 (6 alleles) will~     be performed.~   "
166897|NCT01381172|"~     The objective of this investigation is to evaluate the safety and effectiveness of the~     OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.~   "
166898|NCT01381159|"~     The high burden of asthma appears to be related to poor asthma control, which is associated~     with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and~     worse pulmonary function. Despite the availability of effective treatments, more than 58% of~     asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS) regimens is~     considered by experts to be one of the most important behavioural factors linked to achieving~     optimal asthma control. However, there is a paucity of research on interventions specifically~     designed to improve ICS adherence among adult asthmatics. The vast majority of intervention~     studies to date used atheoretical interventions to target behaviour change, relying mainly~     upon educational approaches which have been criticised for failing to translate knowledge~     into action. This may be due to the fact that most education-based approaches do not~     specifically address or help patients overcome ambivalence about behaviour change, which is~     necessary for ensuring daily adherence. Motivational communication (MC) is a client-centred~     intervention that focuses on enhancing intrinsic motivation to change a particular behaviour,~     and exploring and resolving ambivalence about behaviour change. Brief MC sessions (e.g., 1-5~     x 15-30 minute sessions) have been shown to improve a variety of health behaviours (e.g.,~     reduce alcohol consumption, improve dietary habits, increase exercise behaviour, and improve~     medication adherence) and health outcomes (reduce blood pressure, body mass index, and~     cholesterol levels). However, no studies to date have assessed the efficacy of using MC to~     improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MC to~     improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent~     asthmatics. It is hypothesized that patients randomized to the MC condition will exhibit~     significantly improved ICS adherence at 6 and 12-months post-intervention, independent of~     baseline levels and covariates, relative to patients randomized to the usual care control~     condition.~   "
166899|NCT01381146|"~     The purpose of this study is to evaluate feasibility of modularized delivery of the Impact of~     Crime (IOC) group intervention with jail inmates, and obtain preliminary data on its~     effectiveness in reducing post-release recidivism, substance abuse, and HIV risk behavior.~   "
166900|NCT01381133|"~     The purpose of this study was to evaluate the effectiveness and cost-effectiveness of two~     types of outpatient treatment with and without Assertive Continuing Care (ACC) for 320~     adolescents with substance use disorders. Study participants were randomly assigned to one of~     four conditions: (a) Chestnut's Bloomington Outpatient Treatment (CBOP) without ACC; (b) CBOP~     with ACC; (c) Motivational Enhancement Therapy/Cognitive Behavior Therapy-7 session model~     (MET/CBT7) without ACC; and (d) MET/CBT7 with ACC. Based on prior quasi and experimental~     studies, the investigators hypothesized that MET/CBT would be more effective and~     cost-effective than CBOP in terms of increasing days abstinent and decreasing substance abuse~     problems. Additionally, the investigators hypothesized that the groups receiving ACC would~     have significantly better outcomes than the groups without ACC. Lastly, the investigators~     hypothesized that adding ACC to MET/CBT would be the most cost-effective option in terms of~     days abstinent.~   "
166971|NCT01380210|"~     Carbon dioxide intoxication is a rare condition and only few case reports are found in the~     literature. There were six patients who suffered from carbon dioxide intoxication in our~     hospital about two years ago. Two of them are more severe with conscious change and brain MRI~     studies of the two patients were performed. Reviewing the literature, no any report has~     mentioned about the encephalopathy associated with carbon dioxide intoxication. We want to~     review the brain lesions on the diffusion weighted images and the laboratory data of the~     patients for further diagnostic help.~   "
166901|NCT01381120|"~     Most ureteral stent insertions follow ureteroscopy procedures for stone management. Stents~     are essentially designed to prevent the blockage of the ureter. Such blockage is often a~     result of inflammation caused by ureteroscopy procedures. The stent provides a secure~     passageway for urine as it travels from the kidneys to the bladder, circumventing potential~     urinary retention. In our community, only one kind of stent is used, and it is manufactured~     by Bard. Standard protocol involves the removal of the stent 5 to 8 days following insertion.~     If stenting is required for greater than 8 days, special accommodations will be made for you~     in this study.~      Unfortunately, pain and lower urinary tract symptoms are often associated with the insertion~     and removal of stents. It is our goal to determine whether VESIcare is capable of relieving~     such symptoms.~      As a prospective member of this study, you will be asked to complete three surveys. The first~     survey will ask you about your experiences of urinary urgency and pain before your surgery.~     If you are an emergency patient, you will be asked to remember your condition before the~     surgery, completing this questionnaire at your first post-op visit. If you are not an~     emergency patient, this survey will be completed before your surgery. If your stent is~     removed within 5 to 8 days of surgery, you will be asked to complete the second survey at the~     time of removal. You will then complete the final survey at a scheduled post-operative~     check-up 4 to 5 weeks later. If your stent remains inserted for greater than 8 days after~     surgery, you will be asked to complete the second survey 3 to 4 days after your stent was~     inserted. You will then complete the final survey, 7 to 8 weeks post-op.~      Throughout this study, both VESIcare and non-VESIcare patients will be important in~     determining whether VESIcare truly is capable of relieving stent pain. As such, you will be~     randomly assigned to one of the two groups, those receiving VESIcare, and those who are not.~   "
166902|NCT01381107|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose~     study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with~     buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are~     inadequately/partially responding to current treatment with a stable dose of a~     serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor~     (SNRI).~   "
166903|NCT01381094|"~     The purpose of this study is to evaluate the dose response (efficacy), safety, and~     tolerability of orally administered AKB-6548 in pre-dialysis subjects with anemia with repeat~     dosing for 42 days.~   "
166904|NCT01381081|"~     The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in~     degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing~     effect on knee cartilage degenerative injuries are not conclusive to establish a standard of~     behavior, although PRP has shown to improve joint functionality and reduce pain.~      Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to~     a more effective and lasting functional recovering than corticosteroid intra-articular~     injections.~   "
166905|NCT01381068|"~     This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the~     delivery room. The use of the monitor is compared with clinical assessment of ventilation.~     The hypothesis is that using the monitor would results in a decrease in the incidence of~     hypo- or hypercapnia on admission to the NICU.~   "
166906|NCT01381055|"~     The purpose of this study is to determine whether pentoxifylline associated to pentavalent~     antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous~     leishmaniasis.~   "
166907|NCT01381042|"~     Previous studies have shown active brown adipose tissue (BAT) is present in adults and may~     play important roles in regulating energy homeostasis. However, the majorities of these~     studies were done in patients undergoing scanning for cancer surveillance, and may not~     reflect BAT behavior in healthy individuals. In addition, little is known about the ethnic~     variation in BAT activity, particularly in Chinese adults. Due to the large amount in our~     cohort, we are able to look at the difference between subjects for cancer surveillance (CS)~     and subjects for medical check-up (MC), and to clarify the impact of clinical and lifestyle~     parameters.~   "
166908|NCT01381029|"~     Investigators in the Division of Infectious Diseases are carrying out a study to determine if~     human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza~     vaccination develop an adequate antibody response. The study group will consist of~     individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the~     Seasonal Influenza vaccine.~   "
166909|NCT01381016|"~     The sole purpose of this study is to evaluate pathophysiology of disease. The disease state~     that is being evaluated is the obesity-related alterations in reproductive hormones~        -  The obesity epidemic in the United States is advancing at an accelerated pace. It is~          estimated that by 2015, 41% of U.S. adults will be obese as defined by a body mass index~          (BMI) of greater than 30 kg/m2. The U.S. government's 2010 Dietary Guidelines regard~          obesity as the single greatest health hazard in this century. Female adult obesity is~          associated with menstrual cycle irregularities, ovulatory dysfunction and a higher risk~          of obstetrical complications. This reproductive phenotype of obesity is worsened by~          further increases in BMI and is not solely due to anovulatory infertility. While the~          association of adiposity with subfertility is well documented in population studies, the~          underlying mechanisms remain poorly understood. The main objective of this proposal is~          to clarify the nature of the obesity-related reproductive endocrine abnormalities and~          identify potential etiologies amenable to therapy.~        -  Hypothesis: The hypothalamic-pituitary axis is abnormally sensitive to estradiol~          negative feedback in obesity.~   "
166910|NCT01381003|"~     Chronic Granulomatous Disease (CGD) is a rare inherited disorder in which patients suffer~     from severe infection and inflammation. The first indication of disease usually appears in~     early childhood. The basic defect found to be lie in specialised white blood cells called~     phagocytic cells, which are responsible for engulfing and destroying germs. In CGD, there is~     a defect in an enzyme (known as NADPH-oxidase) that is responsible for generating bleach like~     substances that are important for killing some important germs. In the form of the disease~     known as X-CGD (which accounts for two thirds of patients), there are defined mistakes in a~     gene called gp91-phox, which is a key part of the NADPH-oxidase.~      In many cases, patients can be protected from infection by constant intake of antibiotics.~     However, in others potential life-threatening infections break through. In some cases~     patients also develop serious inflammation requiring high doses of drugs such as steroids.~     CGD can be cured by bone marrow transplant, but the best results are available when there is~     matched donor available. Transplant from unmatched donor have a much worse outcome.~      Gene therapy of CGD can be performed by introducing a normal copy of human gp91-phox gene~     into the blood forming stem cells of patients' bone marrow by using a gene carrier (in this~     study called lentiviral vector). After treatment of the bone marrow cells in a specialised~     laboratory are given back to the patient and will grow into functional phagocytic cells.~   "
167219|NCT01376921|"~     This is a Spanish, Multicentre, Observational Study to study adherence and long term outcomes~     of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone~     treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.~   "
166911|NCT01380990|"~     Adenosine Deaminase (ADA) is an enzyme, needed by body to develop lymphocytes of the immune~     system. Children who are born in mutations with mutations in ADA gene have severe combined~     immunodeficiency (SCID). Children with ADA-deficient SCID generally die in the first year of~     life from severe infections because they do not have immune system that can fight against~     infections. ADA deficient individuals can be cured by bone marrow transplant, but the best~     results are obtained when there is fully matched family donor is available. In the absence of~     a matched related donor, transplants from unrelated or mismatched donors have a much worse~     outcome. There is a form of enzyme therapy (PEG-ADA) for ADA-deficient SCID, in which~     children receive injections of purified ADA enzyme 1-2 times each week. These injections can~     allow the immune system to recover to a level that protects children from infections.~      However, these injections have to be given weekly and are very expensive (£ 125,000 - 200,000~     annually) and the recovery of the immune system is not sustained over time.~      Gene therapy for ADA-deficient SCID could be performed by introducing a normal copy of the~     human ADA gene into the blood forming stem cells of the patient's bone marrow by using a new~     type of gene delivery system (in this trial called a lentiviral vector). The gene corrected~     cells are then transplanted back into the patient after small dose of chemotherapy. These~     gene corrected stem cells can survive into the body and make lymphocytes. In this trial, we~     will determine whether gene therapy for ADA-deficient SCID using lentiviral vector is safe,~     feasible and effective~   "
166912|NCT01380977|"~     This pilot study is designed to evaluate the efficacy of the Impact of Crime (IOC) group~     intervention for jail inmates. The hypothesis is that participants in IOC will show decreases~     in criminogenic thinking, decreases in shame, increases in guilt, and increases in empathy,~     which in turn will be reflected in reduced recidivism (official records and self report),~     relative to those randomly assigned to a treatment as usual group.~   "
166913|NCT01380964|"~     The purpose of this study is to identify potential biomarkers for the diagnosis, disease~     progression assessment and response to treatment in patients with Duchenne Muscular~     Dystrophy.~   "
166914|NCT01380951|"~     Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory~     and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is~     considered to be appropriate for the antiviral treatment on CHB patients with liver~     cirrhosis.~   "
166915|NCT01380938|"~     WRITE study aim at identifying the effectiveness of an innovative individualized schedule of~     treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.~   "
166916|NCT01380925|"~     The research team is studying why some African American families have multiple cases of~     breast cancer.~      This study will help to better understand if there are undiscovered genes unique to African~     Americans that may predict early breast cancer risk.~      Breast cancer survivors AND their relatives who are also breast cancer survivors are being~     recruited to the study.~   "
166917|NCT01380912|"~     A randomised double-blinded study, in which the patients either get methylprednisoloneacetate~     or saline solution in the mastectomy cavity to evaluate the efficacy of~     methylprednisoloneacetate in preventing seroma in patients operated for primary breast~     cancer.~   "
166918|NCT01380899|"~     Parkinson's disease (PD) is a degenerative disease that can be difficult to diagnose. The~     clinicopathological studies had demonstrated a 76% accuracy in the clinical diagnosis of PD.~      At the beginning of PD is difficult for the clinician to distinguish from Parkinsonism Plus~     Syndromes (PPS) due to the similarity of symptoms and the lack of specific diagnostic tests.~      Specific biomarkers to help improve the accuracy of diagnosis and to separate these two~     entities are highly needed~      The histological hallmark for definite diagnosis of PD is the presence of fibrillar~     aggregates of phosphorylated alpha-synuclein called Lewy bodies (LBs) and Lewy neurites.~     Previous autopsy-based studies have revealed that alpha-synuclein is deposited in the~     peripheral autonomic nervous system including the enteric nervous system of the alimentary~     tract, cardiac plexus, adrenal medulla and skin.~      For this reason, in patients with parkinsonism, an alternative tool could be to demonstrate~     alpha-synuclein fibrillar aggregates in the skin, allowing early and appropriate diagnosis.~   "
166919|NCT01380886|"~     This is a randomized, multi-center, double blind, parallel study to compare growth and~     tolerance of healthy term infants fed either control or experimental infant formula.~   "
166920|NCT01380873|"~     This trial is conducted to~        1. assess whether SLM0807 alters pharmacodynamics of HKB0701~        2. estimate the pharmacodynamics of HKB0701 after multiple administration of CJ30001 and~          multiple co-administration of HKB0701/SLM0807 in healthy subject~   "
166921|NCT01380860|"~     The purpose of this study is to compare rates of hernia formation between colostomies created~     with no hernia preventing mesh versus colostomies created with a particular mesh.~   "
166922|NCT01380847|"~     The investigators have shown that epithelial-to-mesenchymal transition (EMT) markers in early~     protocol biopsies of the renal allograft predicts the progression of fibrosis during the~     first year post-transplantation.~      The investigators will develop a non-invasive approach for predicting fibrosis as a~     substitute for the invasive allograft biopsy procedure, by longitudinal assessment of the~     mRNA expression level of genes implicated in EMT/fibrogenesis and inflammation in urinary~     cells from kidney transplant recipients during the first year post-transplantation.~   "
166923|NCT01380834|"~     The objective of this study is to assess the efficacy of paravertebral nerve blocks, single~     shot, with ropivacaine 0.5% for postoperative pain control after elective laparoscopic~     cholecystectomy as compared with incisional administration of same local anesthetic at~     laparoscopic insufflation ports by the surgeon.~   "
166967|NCT01380262|"~     Up to 60% of patients with metastatic colorectal cancer can be treated with one of monoclonal~     antibodies targeted against epidermal growth factor receptor (EGFR). This treatment is~     associated with a specific spectrum of toxicity: acne-like rash from limited up to erythema,~     often with severe pruritus, sometimes combined with other types of skin toxicities (hair and~     nail changes). Previously in STEPP study investigators shown that pre-emptive treatment with~     oral doxycycline (200 mg daily), topical steroids and sun blockers reduces the number of more~     severe skin side effects of panitumumab.~      The study is designed to described the profile of skin toxicity of EGFR blocking drugs~     combined with low-dose doxycycline (100 mg daily) used in the pre-emptive manner.~   "
166924|NCT01380821|"~     Ionizing radiation has a number of harmful effects in humans. The most important among these~     is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell~     can induce cancer. Among the different types of lesions inducted, DNA double-strand breaks~     (DSBs) are considered to be the most relevant effects that can initiate carcinogenesis.~      The investigators are already conducting several other studies to prospectively compare the~     inducted DSBs by coronary CT-angiography and conventional coronary angiography. Extending~     these examinations to investigate the induced DSBs by myocardial scintigraphy allows a~     comparison of all three relevant imaging methods of the heart that incorporate ionizing~     radiation.~      To evaluate this, the investigators are planning to examine patients who are scheduled for a~     clinically indicated myocardial scintigraphy. These examinations are routinely done by the~     Department of Nuclear Medicine in either a 1-day or a 2-day protocol according to the~     diagnostic reference values of the Federal Department for Radiological Protection. Blood~     samples will be taken from these patients at predefined time steps before and after the~     examination and DNA double-strand breaks will be determined from these blood samples~     specifically considering the applied activity of the tracer and the exposition kinetics.~   "
166925|NCT01380808|"~     The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy~     capecitabine.~   "
166926|NCT01380795|"~     The knowledge concerning the biology of the human tumors do not stop widening, in particular~     concerning the molecular mechanisms at the origin of the process of carcinogenesis and its~     ability to become perpetual. The identification and the increasing knowledge of these~     abnormalities allowed during these last years the development of therapeutic strategies~     targeting specifically the molecular pathways involved in the carcinogenesis. It quickly lead~     to numerous therapeutic successes in association with conventional chemotherapy, allowing a~     better individualization of the treatment according to the biological characteristics of the~     tumor of the patient.~      However such therapeutics are effective only if the patients carries specific genomic~     mutations making necessary the systematic research for one kind of mutation.~      The problem is that currently the mutational status is frequently made on the tissue~     resulting from the initial tumor biopsy, and as it is not excluded that the evolution of the~     biology of the metastasis reports a different genomic status, the only theoretical solution~     is then to make biopsy systematically on metastasis, what is not always technically possible.~     The problem still complicates when the investigators know that the biology of the tumor may~     evolve in time, particularly under treatment, with appearance of chemotherapy resistant~     clones. The monitoring of the genomic status of the tumor thus appears to be a crucial stake~     in the next years in cancer research as far as the efficiency of numerous therapeutic~     targeted put at the disposal of the clinician, depends on it largely. The repeated access to~     tumor tissue, during the follow-up of the patient in treatment, seems from then on~     indispensable to guide prematurely the therapeutics, in particular by stopping a targeted~     therapeutics which the investigators know that it is not any more going to be effective, and~     so avoiding exposing the patient to useless toxicity of a treatment often extremely~     expensive, and of which usage should have to be reserved to patient who could respond to it.~      The access to the circulating tumor cells in the blood of patients is a repeatable, not~     invasive technique (blood test) and henceforth accessible thanks to a technique using a~     magnetic sorting of the tumor cells selected by an antibody directed against the tumor~     antigen EpCAM. This new technology (CellSearch, Veridex system) totally standardized and~     automated, allows from a total sample of blood of the patient, to determine the quantity of~     circulating tumor cells (CTC).The number of CTC seems to constitute in recent studies, a~     powerful prognosis tool at the moment diagnosis, but also during treatment, according to its~     decrease or not under chemotherapy. In United States, the Food and Drug Administration (FDA)~     recently approved the use of this system for the quantification of the CTCs in the care of~     the patients affected by breast, colon, and prostate cancer. The CellSearch system will~     probably become in the future years an indispensable tool to help the clinicians to encircle~     better the prognosis of their patient. This technology already allows to realize besides a~     quantification, the isolation of viable CTCs, from which the genetic material can be~     extracted, amplified thus potentially analyzed. The investigators thus see all the interest~     which such a device can represent in the non invasive monitoring of the patients under~     treatment targeting molecular abnormality susceptible to evolve in time. The investigators~     thus propose to study thanks to the system CellSearch the feasibility of the research for the~     mutation of K-Ras and EGFR in the CTC of patients carriers of a metastatic non small cells~     bronchial carcinoma.~      Secondly, the investigators research will be interested in the possible conflicts existing~     between the primitive tumor and the CTCs for the various popular mutations. In case of~     feasibility of the method, and the good initial concordance between the genomic status of the~     CTCs and that of the tumor, the investigators shall describe the genomic evolution under~     treatment monitoring the CTCs of the patients under targeted therapeutics. The investigators~     shall describe then if the premature observation of modification precedes the appearance of~     an effective resistance in treatments.~   "
166927|NCT01380782|"~     BIBF 1120 is a newly discovered compound that may stop cancer cells from growing abnormally.~     This drug is currently being used in treatment for other cancers in research studies and~     information from those other research studies suggests that this agent, BIBF 1120, may help~     to stop recurrent malignant glioma cells from multiplying and it may also prevent the growth~     of new blood vessels at the site of the tumor. In this research study, the investigators are~     looking to see how well BIBF 1120 works in patients with recurrent malignant gliomas.~   "
166928|NCT01380769|"~     The purpose of this study is to compare median overall survival of patients with advanced~     non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best~     supportive care (BSC).~   "
166929|NCT01380756|"~     This study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The~     dose escalation part of the study is aimed at evaluating the safety, tolerability and PK~     (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93 subjects~     may be enrolled in dose escalation. The dose expansion part of the study will consist of 20~     subjects with acute myeloid leukemia. The dose of AMG 900 will be dependent upon data from~     the dose escalation part of the study.~   "
166930|NCT01380743|"~     This study will look at Drug-Drug Interactions Between AT2220 (duvoglustat hydrochloride) and~     alglucosidase alfa (ERT) in Patients with Pompe Disease.~   "
166931|NCT01380730|"~     To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered~     every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from~     baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.~   "
166932|NCT01380717|"~     Patients with reduced kidney function have a higher risk of heart disease and death. Studies~     have shown that blood vessels in patients with hypertension change with a decrease of lumen~     size and growth of the vessel wall. By treating patients with antihypertensive certain~     medication vessel lumen and walls normalize. Treating hypertension in patients with chronic~     kidney disease slows the progression of kidney function loss.~      The aim is to compare different degrees of antihypertensive medication in patients with~     chronic kidney disease and hypertension will slow the progression of kidney loss.~   "
166933|NCT01380704|"~     This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically~     healthy subjects with mild to moderate depressive symptoms who are not taking any~     antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of~     this study.~   "
166934|NCT01380691|"~     This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684~     with Alcohol in Healthy Subjects. This study will run approximately for 34 days.~   "
166935|NCT01380678|"~     The purpose of this study is to evaluate that intralesional injection of bevacizumab on~     primary pterygium can reduce the corneal pterygium area, inflammation, redness and other~     symptoms.~   "
166936|NCT01380665|"~     The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when~     applied to either the hip or knee area over a surgical cut for the time you are hospitalized.~   "
166937|NCT01380652|"~     The aim of this study is to investigate the change of physical activity in COPD-patients~     performing a whole body vibration training additional to a standard three-week rehabilitation~     program in comparison to patients performing merely a standard rehabilitation program.~   "
166938|NCT01380639|"~     The aim of this study is to investigate the exercise capacity in COPD-patients performing a~     vibration training additional to a standard three-week rehabilitation program in comparison~     to patients performing merely a rehabilitation program.~   "
166939|NCT01380626|"~     Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and~     Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation~     in regard to improvement of 6-minute-walking distance. The aim of this study is to~     investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency~     patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with~     strength and endurance training. In addition to conventional diagnostic procedures, muscle~     biopsies from the M. vastus lateralis will be conducted before and after rehabilitation~     program followed by biochemical, histochemical and immunohistochemical analysis of the~     probes.~   "
166940|NCT01380613|"~     The goal of this study is to examine how social networks, neighborhood, and depression are~     related to HIV risk. The intervention is designed to train individuals to cope with feelings~     of depression or stress as a way to reduce their risk for HIV.~   "
166941|NCT01380600|"~     The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594~     (Pexa-Vec) administered intravenously every 2 weeks in colorectal carcinoma patients who are~     refractory to or intolerant of oxaliplatin, irinotecan, and Erbitux treatments.~   "
166942|NCT01380587|"~     The purpose of the study is to determine the utility of XCL1 in the prognosis of acute~     lymphoblastic leukemia.~   "
166955|NCT01380418|"~     Some overweight individuals develop problems with their breathing such that they gradually~     breathe less and less. This leads to a lack of oxygen and a buildup of carbon dioxide in the~     blood, called ventilatory failure. As a consequence, if such a person develops a chest~     infection, they are more likely to become seriously ill and need intensive care. In addition~     they are much more likely to develop severe complications during and following operations.~     This problem can be treated with a machine at home used overnight to help breathing. It is~     interesting that ventilatory failure only happens in some overweight individuals, and the~     investigators do not understand what factors make this complication develop. There are a~     number of theories: for example the distribution of the fat, additional lung disease (such as~     asthma), the addition of obstructive sleep apnoea, a condition when there are periods of~     cessation of breathing overnight (which is more common in obese individuals), weak muscles of~     breathing (perhaps due to fatty infiltration of muscles or vitamin D deficiency), and other~     hormonal changes.~      The investigators intend to measure many potential factors in a range of overweight~     individuals, some who have ventilatory failure, and some who do not, to try and work out~     which are the important factors that cause this problem. If the investigators can identify~     such factors, then this will help predict in advance who is at risk from chest infections and~     during operations; thus allowing for earlier provision of an overnight breathing machine.~     This should reduce complications and potentially deaths in such individuals.~   "
166956|NCT01380405|"~     Given the importance of the correct use of inhalers by patients with Chronic Obstructive~     Pulmonary Disease (COPD) for the appropriate treatment of the disease, the self-care~     programme which will be assessed will consist of an educational intervention on the correct~     use of inhalers.~      For this aim, we have designed this study to assess the influence of both individualized and~     collective self care programmes about the correct use of inhalers improves the functional~     state of patients with COPD compared to when there is no educational intervention.~   "
166957|NCT01380392|"~     The aims of this study are to (1) understand the uncertainty , personality and coping~     strategies in patients with HCC, and identify the significant factors for coping.~   "
166958|NCT01380379|"~     Previous research has shown that self-defense training can lead to gains in women's~     assertiveness, self-esteem, self-efficacy, and physical competence, and decreases in anxiety,~     helplessness, fear, and avoidant behaviors. However, most of this research has been conducted~     with healthy women who had not previously experienced physical or sexual violence. The~     investigators believe that women with such trauma histories require additional care because~     of potential triggering symptoms. As such, the investigators are mindful of the potential for~     triggering trauma symptoms and will work with the women so that they feel safe and~     comfortable in their participation. This pilot study aims to examine whether similar~     psychological gains from self-defense training are made in women who have previous~     experiences of physical and/or sexual violence.~   "
166959|NCT01380366|"~     Patients who are being asked to participate in this study have a short small bowel and will~     be prescribed to take the medication: Zorbtive® (Zorbtive/Somatropin/(rHGH)). Zorbtive® is~     an FDA approved recombinant human growth hormone (rHGH). The investigators want to see if~     taking this medication improves small bowel function by helping it to take in food,~     nutrients, vitamins and minerals. The investigators also believe that if the small bowel is~     absorbing food and nutrients better, liver function will improve as well. Therefore, liver~     function will also be monitored during the course of the study by performing blood tests.~   "
166960|NCT01380353|"~     The purpose of this study is to look for ways to improve breast cancer treatment by giving~     breast cancer drugs through the skin of the breast.~      The drug used in this study is a diclofenac epolamine patch and is a nonsteroid~     anti-inflammatory pain reliever. The drug amount that gathers in the breast, after~     application of a patch to the skin of the breast, will be measured and compared to the amount~     that is found in the breast when the patch is applied to the skin of the belly.~   "
166961|NCT01380340|"~     This study will investigate the effects of a new form of early intervention for senior~     drivers who are at risk of changes to their driving status. The early intervention consists~     of group activities involving planning and professionally facilitated discussion.~      There are three main research hypotheses for this study. Firstly, it is hypothesised that~     early intervention, in the form of the information and planning group, will not be associated~     with either increases or decreases in driving assessment failure or driving cessation.~     Secondly, it is hypothesised that early intervention will be associated with patterns of~     reduced depression and less persistent negative mood states. Thirdly, it is hypothesised that~     early intervention will be associated with patterns of sustained levels of important quality~     of life indicators such as community participation and social relationships.~   "
166962|NCT01380327|"~     This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is~     designed to study biomarkers of the immune response to allergen immunotherapy and the safety~     of this therapy in a pediatric population.~   "
166963|NCT01380314|"~     Cutaneous leishmaniasis is endemic in the New World from approximately the US-Mexican border~     through Central America and the Northern part of South America down to the level of Rio de~     Janeiro.~      Until recently, the standard treatment for the leishmaniases was pentavalent antimony~     (Glucantime or Pentostam). The cure rate for L panamensis in Colombia is 91%-93% [Soto, 1993;~     Velez, 1997], a large study with several formulations of antimony found a combined~     Bolivia-Colombia cure rate of 86% [Soto, 2004b], and in work just completed, the cure rate in~     Palos Blancos, Bolivia is 15 of 16 = 94% [ Soto, manuscript in preparation]. Nevertheless,~     pentavalent antimonials have the disadvantages of multiple injections and mild-moderate~     clinical toxicity [gastrointestinal complaints, liver enzyme elevations, pancreatic enzyme~     elevations], all of which are particularly unpleasant for a moderate clinical problem such as~     cutaneous leishmaniasis.~      The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and~     Bolivia. In Colombia, the cure rate for miltefosine was 91% [Soto 2004a] and in the~     just-completed trial in Palos Blancos, the cure rate for miltefosine was 32 of 37 = 88 % .~     Side effects seen in patients with cutaneous disease that can be specifically attributed to~     the drug are nausea and vomiting of mild grade in approximately 25% of patients, and~     low-grade elevation of creatinine also in approximately 25% of patients [Soto 2001; Soto~     2004].~      The 6-month cure rate did not reach 100%, and miltefosine was relatively slow to cure~     compared to Sb. 31 of 44 evaluable miltefosine patients (70%) were cured by 1 month after~     therapy, compared to 16 of 16 evaluable Glucantime patients (100%).~      Imiquimod (Aldara; 3M Pharmaceuticals) is a novel immune response-activating compound,~     approved by the FDA for cervical warts, that activates macrophage killing of Leishmania~     species. Combined imiquimod plus Glucantime was used as rescue treatment in 12 patients with~     Peruvian cutaneous leishmaniasis who had previously not responded to Glucantime alone. 90% of~     patients were cured at the 6-month follow-up period [Arevalo, 2001]. In a follow up study~     [Miranda-Verastegui et al, 2005], naïve patients were randomized between the combination of~     Sb plus imiquimod (18 patients) vs Sb plus placebo (20 patients). The cure rate at 1 month~     after therapy was 50% in the imiquimod +Sb group compared to 15% in the placebo+Sb group (p =~     0.02). By 12 months after therapy, the Sb+placebo group had caught up, and the cure rate was~     72%-75% in each group. Local side effects were evaluated. Edema, itching, burning, pain were~     equal in the two groups. There was more erythema in the imiquimod grup (55% of patients)~     compared to the placebo group (25% of patients).~      The Imiquimod studies in neighboring Peru suggest that combination with this immunomodulator~     is capable of decreasing the time to cure, and potentially increasing the cure rate, in~     Andean cutaneous leishmaniasis. The present study will evaluate the combination of oral~     miltefosine plus topical imiquimod for cutaneous leishmaniasis in Bolivia. If in the first~     group of patients, cure rate at 1 month after therapy is appreciably above the 70% historic~     value for miltefosine alone and the cure rate at 6 months is greater than the 88% historic~     value for miltefosine alone, subsequent patients will be randomized between~     miltefosine+imiquimod and miltefosine+placebo cream.~   "
166964|NCT01380301|"~     Cutaneous leishmaniasis is endemic in the New World and, until recently, the standard~     treatment was pentavalent antimony. The cure rate for L panamensis in Colombia is 91%-93% and~     the cure rate in Bolivia is also 90%. Nevertheless, pentavalent antimonials have the~     disadvantages of multiple injections and mild-moderate clinical toxicity all of which are~     particularly unpleasant for a moderate clinical problem such as cutaneous leishmaniasis.~      The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and~     Bolivia (91 and 92% respectively). Side effects seen in patients with cutaneous disease that~     can be specifically attributed to the drug are nausea and vomiting of mild grade in~     approximately 25% of patients, and low-grade elevation of creatinine also in approximately~     25% of patients. A further disadvantage of miltefosine is that regimens shorter than 4 weeks~     have not been evaluated for cutaneous disease.~      Combination therapy is now being used for many infectious diseases, such as tuberculosis,~     malaria, and HIV. Combination therapy offers the potential of preventing drug resistance,~     because organisms resistant to one of the drugs may be susceptible to the other drug; and~     also the potential to diminish drug therapy duration and thus side effects. These two~     potential benefits to some extent contradict each other: preventing resistance is best done~     if full courses of both drugs is used; diminishing therapy duration means using less than the~     full course of each drug. The optimum combination regimen is one in which sufficient amounts~     of both drugs are used to have high efficacy, yet the amounts are as low as possible to spare~     patients unnecessarily long courses of drug.~      In the present protocol, the combination of a half-course of miltefosine and a half-course of~     antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and~     antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the~     combination was additive to mildly synergistic against a standard leishmania strain.~   "
166965|NCT01380288|"~     The purpose of this study is to evaluate and compare the changes of cognitive function (as~     measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated~     with and without white matter changes after rivastigmine patch therapy.~   "
166972|NCT01380197|"~     The pathophysiology of sickle cell disease (SCD) manifestations, are complex with~     interactions of intracellular hemoglobin, membrane and endothelial activation but the~     hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes~     are thought to result from ischemia caused when small blood vessels are occluded by~     misshapen, inflexible erythrocytes. Painful episodes are the most common cause of~     hospitalization, morbidity, and impairment for SCD patients. There is no therapy that~     completely prevents or directly aborts painful events for all patients. Consequently,~     treatment for acute VOC is primarily supportive using hydration and medicinal pain control.~     Every pain medication has the potential to relieve pain but is associated with significant~     limitations and side effects.~      The primary hypothesis to be tested in this double blind, randomized controlled trial is that~     Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes~     of acute chest syndrome. The investigators also expect subjects will report fewer side~     effects from respiratory depression, abdominal distention from reduced peristalsis, reduced~     histamine release causing pruritis and still be provided adequate pain control. Further~     hypotheses to be tested is ability to recruit patient participants while being treated in the~     Emergency Department and that continuous infusion of Nalbuphine with accompanying patient~     controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total~     opiates consumption, while decreasing length of hospitalization.~   "
166973|NCT01380184|"~     Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of~     ridaforolimus after administration of single and multiple 40 mg doses in Chinese participants~     with advanced cancer. Part 2 of the study is optional; participants can continue to receive~     the study drug in a weekly regimen of daily oral doses of ridaforolimus 40 mg for 5~     consecutive days followed by 2 days off-drug.~   "
166974|NCT01380171|"~     Children who are born with cleft palate need surgery in order to correct the problem. The~     surgery is needed because the defect allows food to leak into the nose. It also causes the~     patient to be unable to speak correctly, producing a problematic nasal sound. Sometimes the~     first surgery does not completely correct the problem and a second surgery is needed. Looking~     at the records of patients who have had corrective surgeries done in the past would allow the~     surgeons to improve their success rate and reduce the need for secondary surgeries. It would~     also create greater patient safety and reduce cost for families.~   "
166975|NCT01380158|"~     The primary objective of this study, is to determine the effect of a Cup pessary, a device~     that is currently readily available in the USA and similar in design to the Arabin pessary,~     on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous~     birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length~     prior to 23 weeks.~   "
166976|NCT01380145|"~     This was an open-label, single-arm, pilot study of the recombinant MAGE-A3 protein plus the~     immunological adjuvant AS15 (recMAGE-A3 + AS15) in subjects with symptomatic multiple myeloma~     who had completed induction therapy with at least a Very Good Partial Response (VGPR) by the~     International Myeloma Working Group (IMWG) criteria and who were eligible for high-dose~     chemotherapy with autologous stem cell transplant (auto-SCT). The primary objective was to~     determine the safety and tolerability of immunizations when administered prior to stem cell~     mobilization and multiple times after stem cell reinfusion. Secondary objectives were to~     assess the humoral and cellular immunogenicity and clinical outcomes of immunization.~   "
166977|NCT01380132|"~     The purpose of this study is to determine whether anorectal application of Nasha Dx is safe~     and effective for treatment of anal incontinence.~   "
166978|NCT01380119|"~     This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic~     benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among~     Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be~     compared to placebo combined with standard ATT therapy. The trial will consist of one stage~     with sputum evaluation at months 1 and 2.~   "
166979|NCT01380106|"~     This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in~     combination with low dose dexamethasone in patients with relapsed multiple myeloma.~      The investigators propose to use the need for dose reduction as a criterion to judge~     tolerability from various causes. In the veteran population which predominantly is in the~     older age category with number of co-morbidities, a lower dose regimen may be safer and~     advantageous.~      This study expects to enroll approximately 80 subjects from participating VA sites across the~     nation.~      The investigators will evaluate the safety of the two dose regimens by comparing frequency of~     dose reductions. The investigators will also measure how long the responses last with each~     dose.~      Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of~     specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for~     patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM~     are cancers of the blood. It is currently being tested in a variety of cancer conditions. In~     this case it is considered experimental.~      At the time of enrollment, one-half of the subjects will be chosen at random to receive the~     15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide.~     Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d.~     or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will~     be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose~     reduction on the same schedule if the patient cannot tolerate the higher dose of~     dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis.~     Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended.~     Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.~   "
166980|NCT01380093|"~     The primary purpose of this study is to determine the abuse potential of EMBEDA compared to~     controlled release morphine when crushed and taken orally by non-dependent recreational~     opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA~     relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with~     crushed controlled-release morphine and crushed placebo.~   "
166996|NCT01379885|"~     The purpose of this study is to compare the effectiveness of a more feasible method for~     reducing the pain and distress of childhood immunization with the standard method in use at~     the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental~     involvement on the parent and child satisfaction with the immunization experience.~      Study Hypotheses: In the standard, pre-kindergarten, two- or three vaccine sequence, there~     will be no statistically significant group differences between PPT and ST with respect to:~        1. Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary~          outcome);~        2. Parent report of child pain using the FPS-R;~        3. Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and~          Consolability (FLACC) scale14;~        4. Parent and child satisfaction with pain management during immunization measured by a~          5-point Likert type scales;~        5. Time required for completion of immunization from initiation of ST or PPT to 2 minutes~          after completion of the last injection.~   "
166981|NCT01380080|"~     People with HIV have a high chance of becoming infected with TB, especially when they live in~     areas where TB infection is common. It can be difficult to diagnose TB in people who need to~     start HIV treatment right away. Within about 6 months after starting HIV treatment, some of~     these people can become very sick with TB and can even die from it.~      This study is being done in people who are starting HIV treatment and who live in areas where~     the TB infection rate is high. The purpose of this study is to test an experimental approach~     to TB treatment to see if it is better than the usual approach. The experimental approach is~     to start TB treatment at the same time as HIV treatment, even when TB infection has not been~     found. The usual approach is to start TB treatment only if TB infection is found.~      In this study, half of the people will start TB treatment at the same time as they start~     their HIV treatment. The other half will start TB treatment only if TB infection is found.~      The study will also test how safe and effective it is to start TB treatment at about the same~     time as HIV treatment even when TB infection has not been found. The study will collect~     information about diet, whether (and when) people in the study become sicker or die, how well~     their HIV is controlled, how they are feeling, how they are taking their medications, whether~     it matters where they live or what kind of HIV and TB care is standard, how many people are~     diagnosed with TB while in the study, and how the cost of the two treatment options on a~     national level could be compared.~   "
166982|NCT01380067|"~     laparoscopic hernia sac high-ligation~        -  has a high recurrence rate laparoscopic hernia sac high-ligation and the lateral~          umbilicus ligament covering the hernia opening~        -  The investigators developed a method of laparoscopic hernia repair by applying a new~          concept in hernia repair. The hernia opening was tightened, and hernia opening region~          repaired with a lateral umbilicus ligament in a tension-free manner. This method~          combines the advantages of a secure repair achieved by the open method with the minimal~          invasiveness of the laparoscopic method. The investigators hypothesized that the lateral~          umbilicus ligament covering the internal hernia opening region after the laparoscopic~          purse-string knot would result in lower recurrence and the same operation relative~          complication.~   "
166983|NCT01380054|"~     The investigators aim to :~        -  describe and analyse psychological characteristics, cognitive factors and~          representations in patients with Pulmonary Hypertension, a rare disease.~        -  assess the psychological characteristics impact on quality of life, check the~          association between disease and QoL evolution, and the variability of QoL parameters~          over severity class changes and follow-up~   "
166984|NCT01380041|"~     Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Brain~     MRI is very useful for MS diagnosis but prognostic biomarkers are still needed. New therapies~     are also expected to improve MS care. Cytokine arrays provide measure of many different~     inflammation-related molecules that could help understanding the disease. Moreover,~     individual prognosis could be linked with the level of such molecules in the CSF of MS~     patients. The investigators will analyze the cytokine profile of MS and control patients CSF~     to determine a specific profile of MS and look for prognosis implication in a cohort of~     patients with clinically isolated syndromes (first manifesatation of MS).~   "
166985|NCT01380028|"~     The chronic subdural hematoma is a common disease in the population over 60 years. For~     example, in patients over 70 years, it occurs every year 7 new cases per 100,000 people. A~     chronic subdural hematoma is an accumulation of blood in the intracranial space between brain~     membrane (dura mater) and the brain. The origin of blood in this area follows a minor brain~     injury, which causes the rupture of small vessels in the area. During its evolution, the~     volume of the hematoma increases. After a few weeks, the amount of fluid build-up can~     compress the brain. That's when clinical symptoms occur: persistent headaches, neurological~     deficits, seizures, impaired consciousness, cognitive functions (memory loss, impaired~     intellectual function, or hallucinations, etc.). The compression of the brain may cause~     impairment of consciousness resulting in more severe cases coma and death. At this stage, a~     neurosurgical intervention is necessary. Recurrences are numerous (15 to 25% recurrence over~     six months after neurosurgery). That is why in France, about 20% of medical teams administer~     a postoperative treatment with corticosteroids to reduce the risk of recurrence. Until now,~     the potential benefit of this treatment has not yet been confirmed by a clinical study. So~     the purpose of this research.~   "
166986|NCT01380015|"~     The purpose of this study is to investigate the benefits of daily consumption of a high~     rosmarinic acid spearmint tea, developed by the University of Guelph, on measures of pain,~     physical function and disease activity in osteoarthritis of the knee.~      The investigators hypothesize that a spearmint tea high in rosmarinic acid is efficacious in~     mitigating the symptoms of osteoarthritis of the knee through its actions in reducing~     cartilage degradation, oxidative stress and inflammation.~   "
166987|NCT01380002|"~     -  Liver/renal transplantations are now tending to be the most important treatment for~          terminal liver and renal disease. Although transplantation can prevent recipients from~          suffering with critical and fatal symptoms, patients may experience the complication~          from surgery and immunosuppressive drugs. Furthermore, they might have many unmet needs~          in daily life, and so as their spouses. The purpose of this study is to explore the~          home-care needs among the post liver or renal transplant recipients and their spouses,~          and identify the significant factors for care needs.~        -  A cross-sectional correlated design will be used and patients will be recruited by~          purposive sampling from an organ transplant outpatient department at a medical center in~          northern Taiwan. A set of structured questionnaires will be used to collect data.~        -  The result of this study will be helpful for clinical nurses to understand liver or~          renal recipients' physical and mental distress, also identify the potential risk of~          home-care needs and the degree of satisfaction as well.~   "
166988|NCT01379989|"~     The objective of this multicentric, randomised, Phase III study is to demonstrate~     superiority, in terms of prolonged survival, of trabectedin and Pegylated Liposomal~     Doxorubicin (PLD) versus carboplatin and PLD.~      Patients will be randomised to:~      Arm A: PLD 30 mg/m2 and carboplatin AUC 5 Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2~     Patients'/subjects' characteristics: patients over 18 years of age with advanced, progressive~     ovarian cancer 6-12 months after completion of first line treatment with platinum-based~     chemotherapy.~   "
166989|NCT01379976|"~     Study objectives Primary: To compare toxicity free survival of patients treated with ALC~     (acetylcarnitine) plus cisplatin-containing chemotherapy (CHT) versus those treated with~     placebo plus cisplatin-containing chemotherapy.~      Secondary: To compare progression free survival, overall survival, the compliance to~     treatment, the number of episodes of grade 3-4 National Cancer Institute Common Terminology~     Criteria for Adverse Events, version 3.0, neurotoxicity, as well as the proportion of~     patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for~     Adverse Events, neuropathic pain intensity, the clinical signs and/or symptoms (such as~     burning, numbness, itching, etc.) of the sensorial neuropathy between the two treatment arms.~     Study design Multicentre, randomised, double-blind, placebo-controlled, phase III,~     superiority study in patients with advanced or metastatic NSCLC (non small cell lung cancer).~      Patients to be screened for study inclusion are those for which the decision to start a~     cisplatin-containing treatment has been already taken in the context of the clinical~     practice. The type of cisplatin-based treatment is not fixed, but each single investigator is~     free to choose for each single patient among those already approved for first line treatment~     of advanced or metastatic NSCLC.~      Patients meeting the eligibility criteria will be randomized with a 1 : 1 ratio to receive~     ALC + cisplatin-containing CHT or Placebo + cisplatin-containing CHT until patient refusal,~     disease progression, unacceptable toxicity or death. The study will be conducted in Italy in~     approximately 20 investigational centers in order to recruit 650-675 subjects over a 30-month~     period.~      Both efficacy and safety data will be collected. Follow-up will be according to the clinical~     practice. Data capture will continue, for each patient, until death or study closure.~   "
166990|NCT01379963|"~     This retrospective observational study will evaluate the hemoglobin levels in patients with~     renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).~   "
166991|NCT01379950|"~     There is a growing body of evidence to suggest that the resolution of an inflammatory~     reaction is an active process. This process requiring signals that turn off early~     inflammatory stages, as neutrophil infiltration and promote resolution phase, as clearance of~     apoptotic cells. In this array,the relationship between neutrophils, monocytes, and~     macrophages is crucial for the concert process.~      Macrophages possess a plasticity of phenotype that explains their protective as well as~     potentially detrimental role in chronic inflammation and tissue injury. Such heterogeneity~     arises as macrophages differentiate from monocytes and are exposed to specific tissue- and~     hematopoietic cell-derived stimuli. It is important to be able to identify the different~     types of macrophages in this setting. Today's literature can distinguish between 3 main~     phenotypic groups of macrophages. The classically activated M1 macrophages, the alternatively~     activated-M2 macrophages and the resolution phase - rMs macrophages. The third phenotypic~     macrophage might play a crucial rule in the resolution phase, and is called the resolving~     macrophage.~      All of those pro-resolving lipid mediators promote the return to tissue homeostasis .~      The investigators hypothesis is that in periodontal patients the inflammatory process~     continues because the process does not reach the resolution phase, and in that milieu, the~     macrophage might be a key component.~      Within the overall concept of periodontal disease as a model for an inflammatory disease with~     an stoppable inflammatory reaction, the primary aim of the study is to check the macrophage~     characteristics in periodontal patients and to compare it to healthy people.~   "
166992|NCT01379937|"~     The purpose of this study is to assess the safety and immunogenicity of a prime-boost~     schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.~   "
166993|NCT01379924|"~     1. Specific Aims~        1. To evaluate the effects of life skills/parenting groups that are embedded within a~          comprehensive multidisciplinary clinic for adolescent parents (the Young Parents~          Program), using a randomized control design. Specifically, the effect of group~          participation on the following adolescent parent outcomes will be investigated:~             -  Parenting attitudes and skills including empathy, non-violent discipline, role~               appropriateness and developmentally appropriate expectations.~             -  Skills of daily living, social relationships, and work/study at follow-up, as~               measured by the Ansell-Casey Life Skills Assessment Scale.~             -  Depression and perceived social support using the CESD-C and Duke Social Support~               scale.~             -  Repeat pregnancy rates at 12 and 24 months after first delivery.~        2. To evaluate the overall Young Parents Program service delivery as required by the Office~          of Adolescent Pregnancy Programs (project funder) using a cross cutting evaluation of~          health services utilization, social needs and work/educational outcomes.~   "
166994|NCT01379911|"~     Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming~     food. Being able to effectively measure satiety is an important concept that has implications~     in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is~     recognized a useful strategy for weight management. Recently, the category of foods marketed~     as having satiating effects has seen significant growth and this trend is expected to~     continue. The purpose of this project is to develop and validate methods for assessing the~     degree of satiety induced by foods and natural health products using commercially available~     food products.~      This trial will examine the effects of a commercially available yogurt (containing added~     protein and fibre) on self-reported satiety and hunger, as well as food intake in both~     controlled and uncontrolled settings.~   "
166995|NCT01379898|"~     -  Rationale: The optimal preoperative medical management for patients with a~          pheochromocytoma is currently unknown. In particular, there is no agreement with respect~          to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor antagonist~          to be administered before surgical resection of a pheochromocytoma. We hypothesized that~          the competitive alfa1-antagonist doxazosin is superior to the non-competitive alfa1- and~          alfa2-antagonist phenoxybenzamine.~        -  Objective: comparing effects of preoperative treatment with either phenoxybenzamine or~          doxazosin on intraoperative hemodynamic control in patients undergoing surgical~          resection of a pheochromocytoma.~        -  Study design: Randomised controlled open-label trial.~        -  Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign~          pheochromocytoma.~        -  Intervention: Patients are randomised to receive oral treatment with either~          phenoxybenzamine or doxazosin preoperatively.~        -  Main study parameters/endpoints: The main study parameter is defined as the percentage~          of intraoperative time that blood pressure is outside the predefined target range after~          pretreatment with either phenoxybenzamine or doxazosin.~      In this multicenter trial, we compare the effects of two commonly used drugs in patients~     being medically prepared for resection of a benign pheochromocytoma. Participants are not~     subjected to an experimental treatment of any kind, as we merely aim to describe in detail~     the perioperative course in general and, in particular, the intraoperative hemodynamic~     control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A~     routine diagnostic work-up for pheochromocytoma will be performed in all participants. One~     extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and~     participants need to record their symptoms in a diary. In addition, patients who are~     pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with~     an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least 2~     - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment with~     an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by the~     nursing staff. The final site visit is planned at 30 days after surgery, in line with current~     practice.~   "
167021|NCT01379534|"~     This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study~     to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either~     FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.~   "
167022|NCT01379521|"~     This study will evaluate the role of everolimus in combination with local Transcatheter~     Arterial Chemoembolization (TACE) procedure in patients with localized unresectable~     Hepatocellular Carcinoma (HCC).~   "
166997|NCT01379872|"~     The Trans Tasman Radiation Oncology Group (TROG) has been commissioned by the Department of~     Health and Ageing to undertake a project to assess new Radiation Oncology Technology and~     Treatments. This project is being undertaken in response to a recognised need for the~     Medicare Benefits Schedule to support appropriate new radiation oncology technologies and~     treatments as they become available, to ensure optimal patient care.~      The first phase of the project required TROG to develop a Generic Research Framework (the~     Framework) capable of collecting and generating information to substantiate the safety,~     clinical efficacy and cost effectiveness of new technologies and treatments.~      The second (and current) phase of the project requires that the Framework be piloted to~     assess the safety, clinical efficacy and cost effectiveness of Intensity Modulated Radiation~     Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) in four tumour site specific~     regions:~      A. Post Prostatectomy(IMRT) B. Anal Cancer (IMRT) C. Nasopharynx (IMRT) D. Intermediate Risk~     Prostate Cancer (IGRT)~      The aims of the site specific components of the ANROTAT protocol are as follows:~      Protocol A. Develop an approach for applying the Framework to evaluate the safety, clinical~     efficacy and cost-effectiveness of IMRT compared to 3DCRT in patients with prostate cancer~     (PP).~      Protocol B. Develop an approach for applying the Framework to evaluate the safety, clinical~     efficacy and cost-effectiveness of IMRT compared to 3DCRT in AC.~      Protocol C. Develop an approach for applying the Framework to evaluate the safety, clinical~     efficacy and cost-effectiveness of IMRT compared to 3DCRT in NPC.~      Protocol D. Develop an approach for applying the Framework to evaluate the safety, clinical~     efficacy and cost-effectiveness of IGRT compared to non-IGRT in patients with intermediate~     risk prostate cancer.~   "
166998|NCT01379846|"~     The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when~     administered to healthy Japanese infants as multiple subcutaneous doses.~   "
166999|NCT01379833|"~     Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a demyelinating chronic~     progressive or relapsing neuropathy believed to be secondary to an autoimmune response~     against peripheral nerve antigens.5 We have observed two patients with CIDP with decreased~     corneal sensation who also suffered neurotrophic corneal ulcers and severe visual loss in the~     affected eyes. We want to explore the relationship of CIDP and corneal sensitivity. Our~     hypothesis is that people with CIDP have decreased corneal sensation compared to those~     without. We plan to perform a prospective study measuring corneal sensation in patients~     (proposed n=10) with CIDP and without to determine (1) if a difference exists in patients~     with CIDP compared to controls and (2) the magnitude of the difference. If a difference is~     detected in corneal sensitivity in patients with CIDP, this awareness amongst physicians and~     patients may help prevent blinding complications.~   "
167000|NCT01379820|"~     Nasal CPAP is a excellent ventilation modality for newborns, but the incidence of~     pneumothorax is high (65.% - 9%) our hypothesis is when the baby open the mouth or crie the~     pressure in the airway is variable, the investigators evaluate a closed system with a~     intubated baby with a orotracheal system but with a elastic reservoir , the reservoir distend~     and the pressure in the airway is constant ,with this system the investigators protect the~     lungs for damage . The investigators want compare the use of nasal CPAP, mechanical~     ventilation and orotracheal CPAP with a compensation bag (gregory system) in newborns with~     respiratory failure .~   "
167001|NCT01379807|"~     The clinical hypothesis of this study is that the addition of Panitumumab to the first line~     treatment combination of docetaxel plus cisplatin will provide benefit to patients with~     advanced gastric or gastroesophageal junction adenocarcinoma.~   "
167002|NCT01379781|"~     Postpartum depression (PPD) is undertreated and the consequences of this are substantial for~     women and children. Studies show that infant cry/fuss and sleep behavior are associated with~     PPD, and that parenting interventions can change infant behavior, yet these findings have~     never been applied to PPD. In this study, the investigators are teaching parenting skills to~     increase infant nocturnal sleep and reduce fuss/cry behavior to women likely to develop PPD~     to see if the investigators can prevent the onset of this disorder.~   "
167003|NCT01379768|"~     The purpose of this study was to count and analyze the white blood cells in tear samples~     collected from study participants following sleep. The results from contact lens wearers were~     compared with the results from non-contact lens wearers.~   "
167004|NCT01379755|"~     This is a comparison of the functional results and Varus-Valgus Stability in Single-radius~     versus Multi-radius Femoral Component for Total Knee Arthroplasty.~   "
167005|NCT01379742|"~     This study will investigate health related quality of life factors in patients undergoing low~     dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for~     use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel,~     sexual function and bother will be measured by the EPIC questionnaire at various time~     intervals.~   "
167006|NCT01379729|"~     Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT.~     Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during~     hyperglycemic clamp at 180 mg/dl.~      The investigators hypothesize that functional beta-cell mass will be more than 20% compared~     to healthy controls.~      Secondary outcome measurements:~      Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.~      The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against~     base-line (base-line = before first intraperitoneal transplantation):~        -  metabolic control~        -  safety parameters~        -  episodes of hypoglycemia~        -  islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and~          alloantigens using pre-transplant measurements as base-line The investigators~          hypothesize that metabolic control and prevalence of hypoglycemia, will be significantly~          improved till PT month 12.~      Histopathology of a biopsy specimen of the human intraperitoneal beta cell implant, at time~     of the second implant. Comparison with composition of graft, identification of~     microenvironment of host origin and correlation with functional assessment will be performed.~   "
167007|NCT01379716|"~     Postherpetic Neuralgia is a painful nerve condition that can occur when nerve fibers are~     damaged following an outbreak of shingles.~      The purpose of this study is to identify and study abnormalities in the nerves and cells in~     the of patients with postherpetic Neuralgia (PHN) and characterize changes that could be~     responsible for causing nerve pain. This data will be compared to the tissue of healthy~     volunteers. Our goal is that this information will lead to the development of better~     treatment options for people with painful nerve conditions.~   "
167008|NCT01379703|"~     KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which~     lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the~     local marketing authorization with regards to dose, population and indication. No additional~     procedures (other than the standard of care) are to be applied to the patients.~      The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter~     format. The study was carried out in two (2) parts: the first part was initiated in 2004 with~     the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the~     lopinavir/ritonavir tablets had become available in the participating countries.~      The aim of this post-marketing observational study was to obtain further data on clinical,~     biological, and virological outcomes, compliance and tolerability of Kaletra®-containing~     regimen during routine clinical use in the participating countries.~   "
167009|NCT01379690|"~     Type 2 DM patients are at increased risk of falls as a consequence of long term hyperglycemic~     complications including retinopathy and neuropathy, and also as a result of hypoglycaemic~     therapy. Values of A1C <= 7% has been shown to increase the risk of falls in elderly T2DM~     patients .~      Increased fall risk may explain why T2DM patients are at increased risk of hip fractures ,~     despite having a higher bone mineral density as compared to non-T2DM patients. Given the high~     morbidity and mortality (25% mortality in 1st year post-fracture) associated with hip~     fractures , all care must be given to prevent hip fractures in T2DM patients.~      There is controversial data on T2DM medications and fracture risk. Vestergaard showed that~     use of metformin and sulphonylureas decreased the risk of all fractures, while there was~     there was a similar trend with insulin.~      The present study sought to evaluate the relationship between A1c values and the risk of~     fractures in treated patients with T2DM.~   "
167010|NCT01379677|"~     The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82~     PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).~   "
167011|NCT01379664|"~     Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile~     anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble~     but more expensive anesthetic sevoflurane. Even a small reduction in the duration of~     hospitalization would easily compensate for the modest additional cost of sevoflurane. The~     investigators therefore propose to test the primary hypothesis that duration of~     hospitalization is longer with isoflurane than sevoflurane.~      The investigators will also test the secondary hypotheses that: 1) pain scores are greater in~     patients recovering from isoflurane than sevoflurane anesthesia; and, 2) opioid consumption~     is greater after isoflurane than sevoflurane anesthesia. All statistical analyses will be~     adjusted for age, gender, race, baseline risk, 9 and procedure.~   "
167012|NCT01379651|"~     To evaluate the efficacy of a 6-month specific oral tolerance induction (SOTI) protocol in~     inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe~     IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental~     exposure to egg.~   "
167013|NCT01379638|"~     The purpose of this study is to determine whether the patients cardiac output measured before~     cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs than the~     estimated cardiac output from Ficks principle, and thereby prevent organ failure.~   "
167014|NCT01379625|"~     Humans eat long-chain fat in their diet and use it for energy during exercise and during~     periods of fasting. Patients with long-chain fatty acid oxidation disorders cannot use~     dietary fat for energy. They sometimes develop muscle breakdown, and severe pain with~     exercise or illness. They can also develop a heart that does not function properly. These~     patients are tired and expend less energy than people who do not have a long-chain fatty acid~     oxidation disorder. However, they can use a supplement oil called medium chain triglyceride~     or MCT. This study will determine if a new experimental oil called Triheptanoin can decrease~     the muscle pain and increase the heart function and the amount of energy in patients with~     long-chain fatty acid oxidation disorders. Funding source - FDA's OOPD~   "
167015|NCT01379612|"~     The aim of this study is to recruit 50 rectal cancer patients planned to receive standard~     radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy~     and followed by re-scans two and six weeks after initiation of treatment. The objective~     quantitative elastography findings are compared with the TRG score.~      The purpose is to elucidate ultrasonic elastography's ability to predict treatment response~     at an early stage by comparing quantitative ultrasound parameters before, during and after~     treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after~     operation.~   "
167016|NCT01379599|"~     The goal of the proposed project is to determine the effectiveness of a brief motivational~     intervention among Emergency Department (ED) patients who use cocaine and/or heroin to~     prevent Sexually Transmitted Infections (STIs) and Human Immunodeficiency Virus (HIV) by~     comparing cumulative incidence and frequency of safe sex behavior between intervention and~     standard voluntary counseling, testing and referral to substance abuse treatment (control)~     groups over a one year follow-up period.~   "
167017|NCT01379586|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-4053~     across ascending single and multiple doses in healthy adult male and female subjects. The~     secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053~     in healthy adult male and female subjects.~   "
167018|NCT01379573|"~     Women with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a~     child with a life threatening heart condition regardless of whether they have very active~     lupus, are in remission, or have only vague symptoms. This heart problem is referred to as~     congenital heart block (the most serious being third degree complete block) and represents~     damage thought to be caused by these autoantibodies. The heart beats abnormally slowly and~     almost all children require permanent pacemakers before the age of 20. Importantly, women who~     have had one child with heart block have a ten-fold higher risk of having another child with~     the same heart condition. Unfortunately, even close monitoring by special techniques during~     pregnancy does not reverse complete heart block once it is observed. Thus, treatments aimed~     at prevention are critical. This study will evaluate for the first time whether~     hydroxychloroquine, a drug used by many patients with SLE, prevents the development of this~     heart condition. Data from laboratory experiments suggests that this drug, which crosses the~     placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to the~     fetus. The study uses a Simon's 2-Stage design, and plans to enroll 19 patients in Stage 1~     and 35 patients in Stage 2 if Stage 1 is successful. Patients can already be on~     hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that~     fewer than 3 cases of heart block will occur in Stage 1, and fewer than 6 cases will occur~     out of all 54 patients if Stage 2 is reached. The results of this study are expected to~     become an integral part of the counseling of women with anti-Ro/La antibodies who are~     considering pregnancy.~   "
167019|NCT01379560|"~     The purpose of this study is to determine the pharmacodynamics of ocular blood flow~     measurements with multiple drop unoprostone isopropyl administration versus placebo in~     subjects with dry age-related macular degeneration (AMD).~   "
167020|NCT01379547|"~     The trial is aimed to show that implementation of a procalcitonin-guided antibiotics~     algorithm may result in shortened antibiotics course in ICU sepsis patients without inferior~     outcome as compared to the conventional therapy~   "
167023|NCT01379508|"~     The purpose of this study is to evaluate the efficacy and safety following the Roadmap~     Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg~     negative CHB patients. The data from the study should allow for the validation of the Roadmap~     concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative~     CHB patients. As part of a post-approval commitment to the European Health Authorities, the~     data will also be used to provide an optimized clinical treatment strategy for better~     clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from~     the study will contribute to a better scientific understanding, disease management and~     treatment of HBeAg negative CHB patients.~   "
167024|NCT01379495|"~     The purpose of this study is to assess the effect of an educative program including telephone~     follow-up for burn patients regarding the impact of this intervention on the health status~     and return to work at six months after hospital discharge.~   "
167025|NCT01379482|"~     The aims of this study are to investigate whether multimodal treatment of peritoneal~     carcinomatosis from gastric cancer is feasible and to evaluate the clinical outcomes and~     clinical effectiveness of neoadjuvant systemic chemotherapy followed by cytoreductive surgery~     + hyperthermic intraperitoneal chemotherapy + early postoperative intraperitoneal~     chemotherapy, as compared to systemic chemotherapy only, in patients with peritoneal~     carcinomatosis from gastric cancer.~   "
167026|NCT01379469|"~     The primary objective is to determine if the medication Carbamazepine, can be used as a~     therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency .~   "
167027|NCT01379456|"~     To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6~     months after the fracture. The investigators hypothesis is that exercises performed after the~     initial rehabilitation, which focuses on specific components of gait control will improve~     gait and increase level of activity.~   "
167028|NCT01379443|"~     The objective of the study is to compare the usual care and treatment of children and youth~     (0-19 years) with multiple developmental delays and disabilities and their families in Simcoe~     York with a co-ordinated, navigated approach to care using the Children's Treatment Network~     (CTN) services.~   "
167029|NCT01379430|"~     The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and~     MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The~     regime proposed in this trial has protected non-immune volunteers against sporozoite~     challenge in clinical trials performed by Oxford, and so may be protective against naturally~     acquired infection in Kenya.The study population will comprise 30 healthy adult males aged~     18-50.~      The investigators do not propose to include a placebo group. At this stage the investigators~     objective is to describe the safety profile in a small number of individuals, and the~     confidence intervals for the proportion of individuals with a particular event would be too~     wide for meaningful comparison with a placebo group. Immunogenicity will be judged by~     comparison with baseline.~   "
167030|NCT01379417|"~     The main objective is to assess the nutritional benefit of probiotics supplementation on~     premature infants growth. As secondary objectives, different parameters related to probiotics~     tolerance will be measured.~   "
167031|NCT01379404|"~     Patients with severe infections initially require large amounts of fluid as part of~     resuscitation. Later on however, problems may arise from excess fluid such as increased time~     on a ventilator and kidney damage. The amount of fluid a patient has is difficult to assess.~     One approach is to determine the amount of fluid that is present in a large central vein.~     This can be done by physical examination of the jugular veins, or by placing a catheter~     within the vein. Unfortunately this method is unreliable and does not predict the amount of~     fluid a patient has.~      Bioimpedance analysis (BIA), is a device that can determine the amount of fluid in the body~     by measuring the body's electrical properties. It is a quick and painless test that assesses~     volume. The primary objective of this study is to determine if BIA measurements are~     associated with patient important outcomes such as time on a ventilator, risk of kidney~     failure requiring dialysis and death. We will also determine whether BIA is a measure of~     fluid status in ICU patients. This study will assess feasibility in establishing a~     multi-centre study assessing if BIA's role in predicting adverse outcomes and thereby~     prognosis and fluid status. We hypothesize that shorter vector lengths will be associated~     with hypervolemia and less ventilator free days.~   "
167032|NCT01379391|"~     Factors influencing platelet engraftment after allogeneic hematopoietic stem cell~     transplantation (Allo-HSCT) includes previous chemotherapy courses, conditioning regimen, HLA~     compatibility, source of stem cell, CD34+ cell count, infection of virus/bacteria/fungal,~     graft-versus-host disease (GVHD), etc. Large-scaled clinical trials have demonstrated that~     platelet count below 20G/L on 14 days after transplantation is an predictive factor for~     delayed platelet engraftment, which lead to increased platelet infusion requirement and high~     risk of bleeding. Multivariable survival analysis indicated that delayed platelet engraftment~     in Allo-HSCT is independent predictive factor for transplantation related mortality (TRM).~     But effective treatment approaches for delayed platelet recovery after Allo-HSCT are still~     lacking now.~      Recombinant human thrombopoietin (rHuTPO) is a fully modified recombinant human~     thrombopoietin accurately expressed in mammalian cells. The rHuTPO agent manufactured by the~     3Bio Pharmaceutical Limited Liability Company (LLC) in Shenyang is approved by the State Food~     and Drug Administration (SFDA) of China in 2005 and is the first rHuTPO agent available~     globally. RHuTPO was approved for for immune thrombocytopenia and chemotherapy-related~     thrombocytopenia in China. Animal experiments showed that TPO-mobilizing stem cell could~     promote platelet engraftment in Allo-HSCT in mice. As for efficacy and safety of TPO on~     platelet engraftment after Allo-HSCT, it's marginally addressed in clinical trials.~      Based on preliminary research results, investigator designed a phase IV, open-label,~     prospective, multicenter Study of the efficacy and safety of recombinant human thrombopoietin~     injection (rHuTPO, TPIAO)on platelet engraftment in Allo-HSCT in China.~   "
167033|NCT01379378|"~     The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier~     to sexual satisfaction/frequency/desire and if surgical correction of incontinence will~     improve these aspects of sexual health.~   "
167034|NCT01379365|"~     This is a prospective, non-randomized study to evaluate the performance of the MyoScience~     Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.~   "
167035|NCT01379352|"~     The vecuronium requirements may be reduced for recipients of living donor liver~     transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the~     requirements may be different according to the phase of surgery. The requirements may also be~     different according to the preoperative hepatic function as measured by MELD score during~     prehepatic phase, or graft to recipient body weight ratio (GRWR) during neohepatic phase.~     Therefore, the investigators are trying to investigate the difference of vecuronium~     requirements according to the phase of surgery or MELD score, GRWR.~   "
167036|NCT01379339|"~     The primary objective of this study is to determine the first-cycle maximum tolerated dose~     (MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and~     Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma of~     the head and neck for three cycles.~   "
167037|NCT01379326|"~     Objectives:~      The overall objective is to monitor efficacy of mebendazole (MBZ) against Soil-Transmitted~     Helminths (STH).~      The primary objective is:~      (1) to monitor the efficacy a single dose 500 mg of mebendazole (MBZ) against~     Soil-Transmitted Helminths (STH) infections by means of Faecal Egg Count Reduction (FECR) and~     Cure Rate (CR).~      The secondary objectives are:~        1. to assess the occurrence of Necator americanus and Ancylostoma duodenal.~        2. to assess the occurrence of β-tubulin mutations related to resistance before and after~          drug administration.~        3. to evaluate the role of dogs and pigs as reservoir for zoonotic transmission.~   "
167038|NCT01379313|"~     In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the~     disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure.~     The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on~     pulmonary gas exchange by randomized controlled trial.~   "
167039|NCT01379300|"~     This is a study to investigate biomarkers after single oral doses of the anticoagulant agents~     dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly~     subjects.~   "
167040|NCT01379287|"~     Iso-fludelone is a type of chemotherapy drug called an epothilone. Epothilones are drugs that~     attach to proteins in your body called tubulins. Tubulins help cells to grow, and are found~     in both normal and cancer cells. When research animals with cancer were given the study drug,~     Iso-fludelone, the drug attached itself to tubulin and slowed or stopped the cancer cells~     from growing. Other types of epothilones have been tested in cancer patients and were found~     to be safe. A similar epothilone drug and other drugs called taxanes are currently approved~     by the FDA for treating certain types of cancers.~      The purpose of this study is to see the effects, good and/or bad, of this investigational~     drug, Iso-fludelone, on cancer. The term investigational means the study drug being tested~     has not been approved by the United States Food and Drug Administration (FDA) or other~     regulatory agencies. This study is the first time the investigators are using iso-fludelone~     in people. This is a Phase I study. In a Phase I study, the first people to receive the drug~     are given a fairly low dose.~   "
167041|NCT01379274|"~     This phase II study will evaluate the safety and efficacy of combining two active~     agents;Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) for the treatment of~     patients with low to intermediate-1 MDS excluding patients with 5 q deletion. The rationale~     for adding Vidaza® (azacitidine) after 3 months of revlimid monotherapy is that combination~     therapy will result in higher response rates, and potentially longer response duration than~     that achieved with either agent.~      STUDY OBJECTIVES:~      Primary:~      To determine the safety and tolerability of the combination of Revlimid® (lenalidomide) and~     low dose Vidaza® (azacitidine) in patients with low - intermediate-1 risk MDS non 5 q~     deletion who have not responded after 3 months of Revlimid® (lenalidomide) monotherapy~      Secondary:~      To determine the response rate in patients with low - intermediate-1 risk MDS non 5 q~     deletion receiving Revlimid® (lenalidomide) in combination with low dose Vidaza®~     (azacitidine), as defined by the IWG 2006 Revised Response Criteria~   "
167042|NCT01379261|"~     The purpose of this study is to determine whether treatment of patients suffering from~     ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous~     catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous~     coronary intervention (PCI) result in a reduction in infarct size.~   "
167043|NCT01379248|"~     The purpose of this study is to examine the benefit of thrombus aspiration in patients with~     ST-elevation myocardial infarction presenting late after symptom onset.~   "
167044|NCT01379235|"~     Background: The elderly population in western countries and in Israel is constantly growing.~     Falls are one of the common problems among this population. Thus there is a need for falls~     prevention exercise program to be offered in the different settings elderly reside. Most~     methods for physical exercise are dedicated to muscle strengthening and improving balance by~     strengthening external muscles. Pilatis exercise program focuses mainly on strengthening the~     in-depth muscles. The advantage of this method is in its simplicity and availability. This~     method is suitable also for special populations as patients in acute hospitalization. In this~     study, the investigators will evaluate if the pilatis exercise can improve balance of elderly~     population. Physical exercise usually improves the mood. Like any physical exercise, Pilatis~     exercise has a mental advantage, therefore, this study will also examine if pilatis exercise~     can improve quality of life of elderly population.~      Working hypothesis and aims: Pilatis exercise will improve balance and stability~     measurements, and quality of life among elderly population.~      Methods: Randomized, prospective study among elderly patients aged 65 and above belonging to~     Clalit Health Services primary care clinic . Participants of the intervention and control~     group will receive a brochure that will include nutrition and healthy life style~     recommendations. Intervention group: will receive 12 weeks of pilatis exercise 3 times a~     week. The control group will be offered the same intervention at the end of the study period.~     Balance evaluation will be performed using the: Tinetti Balance Gait Scale, Berg Balance~     Scale, Multidirectional Reach Test, Timed Up and Go, Step execution test. The SF-36~     questionnaire will be use to evaluate quality of life.~      Importance: This study will examine the influence of pilatis exercise on balance among the~     elderly. If findings will determine that pilatis does improve balance in the elderly, the~     investigators can further examine pilatis's influence on falls prevention, and minimizing~     falls damages.~      Probable implications to the welfare and health of the aged population:~      Improving balance, falls preventing and minimizing falls damages among elderly; improvement~     in elderly quality of life.~   "
167045|NCT01379222|"~     The purpose of the study is to demonstrate the long term safety and effectiveness of the~     Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic~     aneurysms in a post-approval environment, through the endpoints established in this protocol.~      The clinical objective of the study is to evaluate the long term safety and effectiveness of~     the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related~     Mortality (ARM).~   "
167060|NCT01379027|"~     Evidence-based treatments (EBTs) for mental health conditions are often not available to~     persons needing them in the community. Our aim is to test a novel Internet intervention that~     has the promise of eventually improving the Reach and Implementation of mental health EBTs,~     speeding the translation of research successes into improved community care.~   "
167046|NCT01379209|"~     The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to~     evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients~     undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment.~      The study will be separated into two parts; a dose escalation phase to assess safety,~     followed by a large expansion phase to further evaluate the pharmacologic effects of either a~     Maximum Tolerated Dose, Maximum Feasible Dose or optimal pharmacologically active dose of~     RGI-2001. The initial dose escalation safety portion of the study (Part 1) will include~     higher risk patients and limit the unrelated donor transplants. After safety is established~     in part 1 of the study, the second portion of the study will expand the enrollment criteria~     and allow transplantation by either related or unrelated donors.~      This study will endeavor to identify the dose range at which RGI-2001 has an acceptable~     safety profile, at which biologic activity is observed, and to guide possible dose levels to~     utilize in later phase studies based on biological activity.~   "
167047|NCT01379196|"~     The purpose of this study is to examine the effects of Azithromycin (a macrolide class~     antibiotic), given three times weekly, for patients with active moderate-severe, non~     sight-threatening, Graves Orbitopathy.~      Indices for follow-up will include:~        -  Clinical activity score~        -  Anti-TSH receptor antibody levels~        -  Thickening of extraocular muscles per ultrasound~        -  Quality of life score for Graves Orbitopathy patients~   "
167048|NCT01379183|"~     Magnetic Resonance Imaging (MRI) has proven to be a valuable imaging technique for suspected~     small bowel disease. This technique depends, in part, on adequate distension of the small~     bowel. This is accomplished by administering large volumes of a non-absorbable oral contrast~     material prior to the examination, which typically produces excellent distension of the~     distal small bowel and stomach, but poor distension of the proximal small bowel. Erythromycin~     is a common antibiotic that is known to promote stomach emptying and is used to treat~     diabetics with gastroparesis (poor stomach emptying.) The hypothesis of this study was that~     erythromycin will increase gastric emptying and hence improve small and large intestinal~     distention during MRI.~   "
167049|NCT01379170|"~     Background of the study:~      Thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to promote weight loss,~     which could be beneficial for treating obesity, and type 2 diabetes. Thyroid hormone~     treatment stimulates energy expenditure resulting in increased body heat production, in which~     brown adipose tissue play an important role. It is hypothesized that thyroid hormones would~     induce increased energy expenditure via a process called mitochondrial uncoupling, thereby~     creating an inefficient energy status. Indeed, an in vivo study showed a 70% increased flux~     through the tricarboxylic acid cycle (TCA) and an unchanged ATP synthesis rate upon T3~     treatment in lean, healthy young men. The disproportionate increase in TCA flux compared with~     ATP synthesis suggests increased mitochondrial uncoupling. It is however unknown whether~     increased mitochondrial uncoupling would increase fat oxidation and exerts favorable effects~     on insulin sensitivity. There is compelling evidence that type 2 diabetic patients have high~     levels of fat accumulation in non-adipose tissues, such as skeletal muscle, heart and liver.~     Ectopic fat accumulation is related to insulin resistance, however, why this fat accumulates~     in peripheral organs is not known. Recently, studies reported compromised mitochondrial~     oxidative capacity in type 2 diabetic patients and first-degree relatives of diabetic~     patients, suggested to play an important role. Therefore, subjects suffering from overweight~     and/or type 2 diabetes with overt hypothyroidism form an interesting group for examining the~     metabolic effects of thyroid hormone treatment, as less is known about the effects of thyroid~     hormone treatment in these groups.~      Objective of the study:~      The purpose of this study is to evaluate whether thyroid hormone replacement therapy in type~     2 diabetic patients suffering from overt hypothyroidism, will improve muscular mitochondrial~     function, lower ectopic fat accumulation in muscle and liver, increase brown adipose tissue~     activity and enhance insulin sensitivity.~      Study design:~      Type 2 diabetic patients diagnosed with hypothyroidism will undergo 3 months of thyroid~     hormone replacement therapy (THRT) (Euthyrox®, Merck, Germany). Patients will be~     metabolically characterized (such as insulin sensitivity and fat accumulation in peripheral~     tissues) before and after this thyroid hormone replacement therapy.~      Study population:~      17 type 2 diabetic patients diagnosed with overt hypothyroidism (9 from the Netherlands, 8~     from Germany which will only do the PET-CT)~      Primary study parameters/outcome of the study:~      Thyroid hormone-induced change in whole body insulin sensitivity (change in~     insulin-stimulated glucose disposal) and muscle mitochondrial function.~      Secondary study parameters/outcome of the study (if applicable):~      Thyroid hormone-induced change of lipid content in skeletal muscle and liver and brown~     adipose tissue activity.~   "
167050|NCT01379157|"~     Imipenem is a carbapenem antibacterial agent with a broad spectrum of activity against~     Gram-negative and Gram-positive bacteria. This agent is often used as the last line of~     therapy for highly resistant Gram negative bacilli nosocomial infections. In common with~     other beta-lactamase inhibitor, the main pharmacokinetic/pharmacodynamic (PK/PD) index that~     correlates with the therapeutic efficacy is the time that concentrations in the tissue and~     serum are above the MIC and administration by continuous infusion is the preferred mode of~     administration to maximize this parameter.~      However, in tropical countries, the stability of carbapenem antibiotics is an important~     consideration when considering continuous infusion. Therefore, prolonged infusion may be a~     useful mode of administration to maximize bactericidal activity. This study will demonstrate~     the stability of imipenem in clinical use at room temperature in tropical countries.~   "
167051|NCT01379144|"~     The primary objective of this study was to compare the change in intraocular pressure (IOP)~     of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50~     ug/ml dose, in a dose ranging study.~   "
167052|NCT01379131|"~     Some myocardial infarctions (MI) occur as the first manifestation of atherosclerotic disease.~     Such MIs are important because of the high likelihood of missed opportunities for prevention.~     A recent analysis using CALIBER data estimated this proportion at 60%.~      Further to this research, another level of complexity can be added to improve our~     understanding of these MIs. This is the concept of a completely 'unanticipated' MI, which can~     be defined as: MI occurring as the first manifestation of atherosclerotic disease and without~     any traditional cardiovascular risk factors and without any prior chest pain. Such~     'unanticipated' MIs cannot be foreseen by the medical profession and their frequency in the~     population is unknown.~      Therefore the aim of this study is to describe the distribution of previously diagnosed~     cardiovascular disease, cardiovascular risk factors and chest pain in patients with first MI.~     This will provide an estimate of the number of 'unanticipated' MIs and of the levels of risk~     factors in unheralded, compared to heralded MI.~   "
167053|NCT01379118|"~     This study is to determine the relevancy of clinical scales for outcome measures as compared~     to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee~     Society Score and the WOMAC Score will be obtained from patients. Gait data will also be~     obtained from total knee replacement (TKR) patients at pre-operative and post-operative~     times. Gait data will be measured on unaffected normal controls as a second baseline.~      The hypothesis is that the subjects clinical outcome measures do not accurately reflect gait~     dependent outcomes amd functional performance of the total knee replacement.~   "
167087|NCT01378676|"~     The study will generate data on safety and tolerability after multiple daily doses of~     CK-2017357 in patients with ALS. Patients will be randomized into one of four different~     treatment groups, receiving daily oral doses of either placebo, 125 mg, 250 mg, or 375 mg of~     CK-2017357 for 14 days.~   "
167054|NCT01379105|"~     The objective of this experimental study was to compare the electromyographic responses of~     sedentary youth with and without the administration of static stretching and neural~     mobilization. The sample was composed of sedentary students, divided, randomly, into neural~     mobilization practitioners (NMG; n=15; age=22±3 years), static stretching practitioners (SSG;~     n=15; age=23±4 years) and a control group (CG; n=15; age: 24±4 years). For this evaluation,~     an electromyograph (EMG; a four channel system) was used to monitor electrical activity in~     the femoral bicep muscles). In neural mobilization, hip flexion was conducted passively with~     the knee extended, and 30 plantar-to-dorsal flexion oscillations were completed per minute.~     For the static stretching, hip flexion with was completed passively with the knee extended~     and held for 6 seconds. The perception of effort was evaluated using the Perceived Force in~     Flexibility Scale. The statistical significance level was p<0.05. Descriptive statistics such~     as the average, standard deviation, median, standard error and absolute change within groups~     (post-test - pretest) were calculated. The sample normality was evaluated using the~     Shapiro-Wilk test. For the response variable analysis, the paired Student's t-test (paired)~     or Wilcoxon test (nonparametric) was used for intragroup analysis. For the intergroup~     analysis, the multivariate analysis of variance (ANOVA) test was used, followed by the Tukey~     Post-Hoc test. A p<0.05 significance level was adopted for the statistical evaluations.~     Microsoft Excel and the Statistical Package for Social Science (SPSS) version 14.0 were used~     for evaluation of the results.~   "
167055|NCT01379092|"~     The objective of this study is to evaluate the image quality and operation of a~     self-contained direct digital radiography system for breast specimen imaging.~   "
167056|NCT01379079|"~     Aspirin is a cornerstone in the secondary prevention of cardiovascular disease (CVD) and is~     usually taken on awakening, although evidence regarding optimal time of intake is lacking.~     Recent studies in healthy subjects with mild hypertension showed that aspirin at bedtime~     decreases blood pressure (-7/5mmHg), whereas intake of aspirin on awakening does not.~     Additionally, the investigators found that aspirin at bedtime decreases plasma renin~     activity, catecholamines and cortisol over 24hrs. Time-dependent effects of aspirin have~     never been studied in patients with CVD, who may use concomitant antihypertensive drugs.~     Moreover, platelet reactivity has a circadian rhythm, and intake of aspirin at bedtime may~     attenuate the morning peak in platelet reactivity. The investigators hypothesize that aspirin~     intake at bedtime compared with on awakening decreases both blood pressure and platelet~     reactivity over 24h.~      A randomized open-label blinded endpoint crossover trial in which 250 patients, recruited~     from primary care, will be included who use aspirin for secondary prevention of CVD and have~     a stable blood pressure of 149/94mmHg or lower. Study subjects will randomly use both aspirin~     on awakening and at bedtime during two intervention periods of three months. Blood pressure~     will be recorded for 24hrs at the end of each treatment period in the patients' normal daily~     situation. To assess effects on platelet inhibition, thromboxane-B2 levels will be measured~     in a 24h urine sample at the end of both treatment periods. The investigators will asses~     differential effects according to time of intake on gastrointestinal complaints and potential~     minor bleeding events, as well as compliance.~      The aim of this study is to evaluate the effect of aspirin taken at bedtime compared with on~     awakening on blood pressure of subjects with stable CVD. In addition, it will generate~     insights into the effect of aspirin on platelet reactivity over 24hrs, potential side effects~     and compliance.~   "
167057|NCT01379066|"~     The Pulmonary Colonization Test is a non-invasive breath test for markers of lower~     respiratory tract infection, which may predict the probability of mycobacterial organisms in~     the lower respiratory tract. It consists of:~        -  A breath collection apparatus for collection of volatile organic compounds in breath~          onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample~          of room air.~        -  Analysis of the volatile organic compounds in breath and room air by short acoustic~          wave/gas chromatography.~        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order~          to predict the probability of lower respiratory tract colonization and infection.~        -  Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas~          chromatography.~      This study will test the hypothesis that the investigators can identify the presence of~     mycobacteria in an individual by sampling the breath of patients with active tuberculosis and~     by sampling head space above culture media of sputum provided. This study will test the~     hypotheses:~        -  that the investigators can identify positive cultures for mycobacterium tuberculosis~          through sampling of the headspace above the cultures prior to standard laboratory~          culture identification~        -  that the investigators can identify control of tuberculosis by sampling exhaled breath~   "
167058|NCT01379053|"~     The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus,~     which may predict the probability of bacterial organisms in the anterior nares, throat and~     respiratory tract, wounds, and anus and therefore be able to replace or supplement current~     active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists~     of:~        -  A collection apparatus for collection of volatile compounds from suspected infection~          sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate~          sample of room air.~        -  Analysis of the volatile organic compounds from suspected infection sites and room air~          by short acoustic wave gas chromatography.~        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order~          to predict the probability of Staphylococcus aureus infection and colonization.~      This study will test the hypothesis that we can identify the presence of MRSA by sampling the~     head space above culture media of anterior nare samples provided by patients with MRSA.~     Additionally, this study will test the hypothesis that we can identify the presence of MRSA~     by sampling air exhaled through the nostrils (nasal exhalant).~   "
167059|NCT01379040|"~     This experiment is designed to test the effectiveness of a new electronic nose device, which~     allows a non-invasive breath test for markers of lower respiratory tract infection, which may~     predict the probability of bacterial organisms in the lower respiratory tract. It consists~     of:~        -  A breath collection apparatus for collection of volatile organic compounds in breath~          onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample~          of room air.~        -  Analysis of the volatile organic compounds in breath and room air by short acoustic~          wave/gas chromatography.~        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order~          to predict the probability of lower respiratory tract colonization and infection.~      This study will test the hypothesis that the investigators can identify the presence of~     Pseudomonas aeruginosa by sampling the head space above culture media of sputum provided by~     patients with cystic fibrosis. This study will test the additional hypothesis that the~     investigators can identify the presence of Pseudomonas aeruginosa by sampling exhaled breath~     from the patient providing the sputum.~   "
167109|NCT01378390|"~     The purpose of this study is to determine safety and efficacy of eASCs (expanded adult stem~     cells) for treatment of complex perianal fistulas in patients with Crohn's disease.~   "
167061|NCT01379014|"~     A decision aid tool (DAT) to assist mental health service users in reaching disclosure~     decisions in the context of employment was developed in a previous study (IRAS REC ref:~     07/Q0706/21). The initial feasibility and acceptability was assessed in a group of 15 mental~     health service users with mean decisional conflict scores reduced from 51.98 to 35.52 after~     completion. 60% of participants reported that the DAT was quick to complete, 40% that it was~     easy, 60% that it was relevant and 80% that they would definitely or probably use it in~     making disclosure decisions. This current study (CORAL: Proof of concept RCT) aims to~     determine whether a full randomised controlled trial of the DAT is justifiable and feasible,~     and to optimise its design. This will consider: 1) effects of the intervention; 2) baseline~     predictors of disclosure; and 3) exploration of the relationship between use of the DAT and~     the rate of disclosure.~      Eighty people who are on the caseload of a vocational specialist working with people with~     mental illness will be included in this study. All participants will be receiving treatment~     from an Improving Access to Psychological Therapies (IAPT) service or a Community Mental~     Health Team (CMHT). An equal number from each group will be allocated to receive either the~     DAT intervention or treatment as usual. Individuals from both groups will complete baseline~     assessment and 3month followup assessments. Those allocated to the intervention will also~     complete an assessment immediately following the intervention. Qualitative interviews will~     also be conducted at 3 months with a maximum of 15 people from the intervention group and 6~     people from the control group.~   "
167062|NCT01379001|"~     This research study will look at how medications affect the pattern of blood flow in the~     brain. This study will use a special type of MRI (magnetic resonance imaging) scan called~     perfusion MRI to make measurements of cerebral (brain) blood flow. The medications we will~     use in this study are scopolamine (commonly used to treat motion sickness), mecamylamine~     (used to treat high blood pressure), and donepezil (used to treat memory loss). Cognitive~     testing will also be obtained, and correlated with the blood flow patterns in the brain.~   "
167063|NCT01378988|"~     The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety~     of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through~     <24 months, administered as an intravenous loading dose followed by continuous infusion for a~     minimum of 6 hours and up to 24 hours in an intensive care setting.~   "
167064|NCT01378975|"~     This open-label, single-arm, multicenter study will evaluate the efficacy and safety in~     participants with metastatic melanoma who developed brain metastases. Participants may or may~     not have received prior systemic treatment for metastatic melanoma [except treatment with~     v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase~     (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily~     until disease progression, unacceptable toxicity or consent withdrawal.~   "
167065|NCT01378962|"~     This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in~     participants with locally advanced or metastatic non-small cell lung cancer. Participants~     received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12~     months.~   "
167066|NCT01378949|"~     A psoas compartment block has been used with good results for postoperative pain relief after~     total hip arthroplasty (THA). However, case reports describing serious complications after~     the use of this block, have been reported. The fascia iliaca compartment block (FICB) has~     been shown to be a reliable block for postoperative pain relief for procedures and injuries~     involving the hip. The investigators have not found any literature that has compared these~     two blocks. This study will compare the two blocks when used for post-operative pain relief~     after THA.~   "
167067|NCT01378936|"~     The purpose of this study is to evaluate whether the Impact of Crime (IOC) group intervention~     with jail inmates reduces post-release recidivism, substance abuse, and HIV risk behavior.~   "
167068|NCT01378923|"~     This is a pilot study to examine the acceptability and effectiveness of the Re-Entry Values~     and Mindfulness Program (REVAMP), a group intervention for jail inmates. It is hypothesized~     that REVAMP will reduce post-release recidivism, substance abuse, and HIV risk behavior.~   "
167069|NCT01378910|"~     CCR5 antagonists might be an adequate alternative for HIV-1-infected individuals with~     suppressed viremia who experience antiretroviral-related toxicity. The assessment of HIV-1~     tropism in proviral DNA could be helpful to inform in which of these subjects CCR5~     antagonists could be efficacious.~   "
167070|NCT01378897|"~     The purpose of this study is to evaluate a new educational program for people who have~     recently had gastric bypass surgery. This program involves both the use of newly developed~     wireless home monitoring technology (medication box, weight scale, and pedometer) and~     telephone-based, individually tailored health counseling with a bariatric dietician.~   "
167071|NCT01378884|"~     The purpose of this study is to determine whether domperidone can be used safely and~     effectively for patient with gastroparesis.~   "
167072|NCT01378871|"~     This clinical trial will be a multicenter phase II fixed-dose trial in which a minimum of 10~     patients with immunophenotypically confirmed ATL with at least 50% of the blasts expressing~     CD25 as measured by flow cytometry at relapse, will receive Imtox-25. Patients are eligible~     for repeat courses of treatment every two weeks if they do not experience a dose limiting~     toxicity (DLT) as defined in Section 5.2 and do not have a HAMA/HARA level > 1 μg/ml. The~     treatment will be administered in the in-patient setting. If no response is observed among~     the initial 9 patients, the study would be terminated early and declared negative; if at~     least one response is observed, accrual would continue to a total of 17 evaluable patients~     (total study size=19 to account for 10% of the patients being unevaluable for any reason).~   "
167073|NCT01378858|"~     This randomized trial will evaluate whether varenicline directly observed therapy provided at~     a methadone clinic is more efficacious than self-administered varenicline for promoting~     smoking cessation and enhancing adherence.~   "
167074|NCT01378845|"~     The purpose of this study is to evaluate the prognostic influence of light rheography~     measurement at the fingertips from subjects with secundary Raynaud syndrome.~   "
167075|NCT01378832|"~     Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.~   "
167076|NCT01378819|"~     The 3-midline-ports technique is a safety approach and associates lower postoperative pain,~     when compared with the standard French technique.~   "
167077|NCT01378806|"~     Young children who are overweight or at risk for overweight are at increased risk for~     becoming obese as young adults and developing type 2 diabetes and cardiovascular disease. To~     date, there have been no interdisciplinary interventions that targeted predominantly ethnic~     minority low-income children and parents and taught them to work together to improve~     nutrition and exercise. Using a two-group, repeated measures experimental design, this~     proposed study will test a 12-week intensive intervention on nutrition, exercise and coping~     skills (Phase I) and 9 months of continued monthly contact (Phase II) to help overweight 2nd,~     3rd, and 4th grade children and their parents improve self-efficacy, health behaviors, weight~     status, and adiposity. The study will take this intervention to the community in which~     children and parents live, working with four schools in Alamance-Burlington County, NC, and~     four schools in Wilson County in the early evening. A total of 356 Black, Hispanic, and White~     children with a BMI >85th percentile and 356 parents with a BMI >25 kg/m2 will be inducted~     over 3 ½ years and randomized by school to either the experimental or control group. Data~     will be collected at Time 1 (Baseline), Time 2 (Post Phase I-Intensive Intervention), Time 3~     (Post Phase II-Continued Contact), and Time 4 (6-Month Follow-Up). Data collected will~     include scores on the Health Promoting Lifestyle Profile II in the parents; eating~     self-efficacy in the children (CATCH) and parents (Eating Self-Efficacy Scale) and exercise~     self-efficacy in the children (CATCH) and parents (Exercise Self-Efficacy); health behaviors~     in the children and parents (3 Day 24-Hour Food Recall and 4 Day Accelerometry Measurement);~     weight status in the children (BMI percentile) and parents (BMI); and adiposity in the~     children and parents (waist circumference and triceps and subscapular skinfolds). Data~     analysis will use general linear mixed models to test the hypotheses. Decreasing overweight~     in children and parents is urgently needed, and helping children and parents to work together~     to improve their nutrition and exercise patterns by making small lifestyle pattern changes~     may decrease future health care costs and decrease morbidity and mortality. The knowledge to~     be gained from this study may provide a foundation for extending this intervention to other~     Black, Hispanic, and White children and parents in other communities to assist them to manage~     their weight.~   "
167078|NCT01378793|"~     The purpose of this study is to examine the effect of 6-weeks of relaxation acupressure~     compared to stimulating acupressure or a standard of care on sleep and daytime functioning.~     Also, to evaluate the ability of teaching acupressure using web-based applications.~      It is believed that self-administered relaxation acupressure will result in improvements of~     sleep quality and quantity as compared to stimulating acupressure or a standard of care.~   "
167079|NCT01378780|"~     Stroke is a disease with tremendous individual, family, and societal impact. It is the number~     one cause of adult disability and third leading cause of death in the United States. Between~     now and the year 2050, the cost of stroke in the United States will exceed 2 trillion~     dollars. There is a tremendous ethnic disparity with respect to stroke in the United States.~     Mexican Americans are much more likely to have a stroke compared with European Americans. In~     Mexican Americans strokes occur at younger ages, are more likely to recur and have the same~     severity as they do in European Americans. Mexican Americans are the overwhelming largest~     sub-population of Hispanic Americans, the nation's largest minority group. This proposal, a~     scientifically-based rigorous behavioral education intervention trial, seeks to aggressively~     prevent stroke, especially in Mexican Americans.~      Faith and family are strong components of Mexican American culture. This project works with~     these positive fundamental elements in order to affect stroke prevention. This project will~     take place in Nueces County, Texas. The project investigators have worked in this community~     for the past 14 years and have published extensively regarding the stroke health disparity in~     this stable, non-immigrant community of Mexican Americans and European Americans. We have~     established a strong partnership with the Catholic Diocese of Corpus Christi and assembled a~     team with tremendous experience at successful health behavior intervention research.~     Together, a proposal has been crafted that will directly speak to aggressive stroke risk~     factor reduction in Mexican Americans and European Americans in this representative United~     States community.~      The significance of such research is tremendous. As the Mexican American population grows and~     ages, the stroke impact will be felt with greater and greater intensity. Now is the time to~     develop aggressive, scientifically tested interventions to limit the burden of this disease~     on this important segment of the United States population, and to reduce the costs of this~     disease to the country as a whole, in keeping with the Government Performance and Results Act~     (GPRA) goal to identify culturally appropriate, effective stroke prevention programs for~     nationwide implementation in minority communities by FY2010.~   "
167080|NCT01378767|"~     The investigators hypothesized that individuals supplementing with krill oil capsules (two~     grams per day) would experience enhanced improvements in health-related variables during a~     21-day Daniel Fast.~   "
167081|NCT01378754|"~     Interstitial cystitis is a condition where a defect in the protective lining of the bladder~     causes the urinary symptoms such as urgency, frequency and pain/burning on urination. One way~     to help ease the symptoms of this disease is to fill the bladder full of water every 4 to 6~     months.~      Since this is a painful procedure an anesthesiologist will give you a drug that will make you~     unconscious for the procedure. General anesthesia can be given to you through an IV tube that~     is placed in a vein in your arm. There are only a few agents that induce sedation and these~     agents have certain disadvantages such as waking up slowly, low blood pressure, and pain at~     the injection site and a prolonged time to consciousness.~      This study will be comparing doses of a new IV sedation induction agent drug to put you to~     sleep called fospropofol (Lusedra®).~   "
167082|NCT01378741|"~     The objective of this study is to reduce the incidence of postoperative delirium after~     cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce~     delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation~     protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist~     (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource~     utilization analysis will be performed to determine cost effectiveness of the new treatment~     modality.~   "
167083|NCT01378728|"~     The primary objective of this clinical study is to evaluate the use and effectiveness of our~     'handheld' fluorescence digital imaging device platform for real-time non-invasive clinical~     monitoring of chronic wounds for healing and bacterial contamination/infectious status over~     time. This will enable us to determine if the device can detect and longitudinally track~     intrinsic changes that may occur during the wound healing process including, but not limited~     to, collagen re-modeling and bacterial infection of the wound site.~   "
167084|NCT01378715|"~     The aim of this study is to determine whether a pre-treatment with high-dose statin (one day~     prior and just before intervention, rosuvastatin 20mg/day) has a positive impact on the~     occurrence of periprocedural myocardial infarction during percutaneous coronary intervention~     (PCI).~   "
167085|NCT01378702|"~     The objective of this clinical trial is to describe safety, tolerability and the course of~     parameters of the immune system during administration of different doses of two~     subcutaneously administered mistletoe preparations (Iscucin populi and Viscum Mali e planta~     tota) in healthy volunteers, compared to placebo.~   "
167086|NCT01378689|"~     This quality improvement project is aimed at improving health care by identifying low cost~     strategies to get Rheumatoid Arthritis (RA) patients to more effectively communicate with~     their physicians about osteoporosis prevention and treatment (improving doctor-patient~     communication). The investigators will implement a direct to patient intervention to the~     population of interest (patients on chronic glucocorticoids) via story-telling, using an~     Internet based video. The target audience is people on chronic glucocorticoids not already~     receiving bones-specific osteoporosis medications to determine differences in~     post-intervention rates of osteoporosis care, and the rates of prescription anti-osteoporosis~     therapies.~   "
167088|NCT01378663|"~     One of the main problems that faces children undergoing congenital cardiac surgery is~     posoperative pain management. PCAs (Patient Controlled Analgesia) and NCAs (Nurse Controlled~     Analgesia) are the main means of pain management here at NCH. In this study, the~     investigators will review the difference between different PCA and NCA modalities. Also, the~     investigators aim to find out if there are differences between age groups in terms of type of~     drug used, total drug used, side effects and length of use of the PCA or NCA.~   "
167089|NCT01378650|"~     1. Overview of tinnitus Tinnitus is a noisy sound which is perceived without any external~          sound source. According to the survey of the US, 10-20% of adult have the symptom of~          tinnitus and 3-5% of tinnitus patients have severe discomfort of daily life. Severe~          tinnitus can result in psychiatric problems such as depression and anxiety disorders.~          Enhancement of environmental sound, hearing aids, sound generators, cognitive therapy,~          transcranial magnetic therapy, and drug therapy have been tried for treatment of~          tinnitus. Nitric oxide(NO) is a well-known neurotransmitter acting as a vasodilator~          through regulation of production of cyclic guanosine monophosphate(cGMP) and can be~          found in various sites of cochlea. It is reported that cGMP enhances activity of protein~          kinase A (PKA), a mediator of platelet aggregation inhibition and vasodilatation and~          results in increase of vascular flow.~        2. Characteristics of the clinical research drug, cilostazol Cilostazol inhibits~          phosphodiesterase type 3 (PDE3) selectively and increases amount of cAMP by inhibition~          of degradation of cyclic adenosine monophosphate(cAMP). cAMP again by increasing the~          active form of PKA suppress the production of blood clots and increase blood flow by~          expanding blood vessels. Anti-platelet activity and vasodilatation effect of cilostazol~          have been used for improvement of diabetic peripheral vascular disorders and suppression~          of stroke recurrence. Previous studies reported that by increasing the activity of NO~          and PKA, the blood flow of stria vascularis and cochlear hair cells can be improved.~          These studies implies that cilostazol, which causes inhibition of PDE3 and increase of~          PKA, can have a potential effect on improvement of tinnitus by increase of blood flow to~          peripheral cochlear cells. Thus, we hypothesized that cilostazol, which has been widely~          used for enhancing peripheral blood flow, can bring improvement of tinnitus by causing~          better peripheral blood flow of cochlea.~        3. The aim of the study We planned this study to validate the assumptions of the~          background. The aim of our study is whether administration of cilostazol can improve~          tinnitus in terms of subjective degree of symptoms in chronic tinnitus patients.~   "
167090|NCT01378637|"~     The purpose of this protocol is to determine if individuals who had a stroke more than one~     year before entering the study and whose ankles remain substantially impaired are able to~     sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy~     device (AMES).~   "
167091|NCT01378624|"~     Ex vivo effect of fragments and modified forms of surfactant protein D on pulmonary immune~     cells derived from bronchoalveolar lavage after segmental allergen challenge in patients with~     asthma and pilot study to assess local inflammation induced by segmental allergen challenge~     by magnetic resonance imaging.~   "
167092|NCT01378611|"~     Clinical randomized controlled observer blinded add-on design. Additionally there will be a~     non-controlled follow-up phase of the study. Children (Age 4-18 years) with intractable~     epilepsy, and not eligible for resective surgery will be treated with VNS.~      Aim of the study:~        1. To evaluate tolerability and effectiveness of VNS in children with intractable epilepsy~          and cognitive and behavioural problems in a controlled study.~        2. To evaluate the effect of VNS on the immune system which, in its turn, will lead to~          changes in the serotonin metabolic pathway~        3. To link the therapeutic effect of VNS to changes in the serotonin (5HT) metabolic~          pathway.~      In addition the investigators hope to detect some markers of immune and neurotransmitter~     function that enable us to predict 1) Neuronal cell loss in relation to cognitive decline 2)~     the response to therapeutic treatment of VNS.~      Hypothesis:~      The investigators aim to explore neuronal correlates for cognitive morbidity in children with~     intractable epilepsy and to relate this to morphologic changes, biochemical markers, and to~     epilepsy characteristics.~      Correction of the stressed pro-inflammatory status of monocytes/macrophages via an~     electrical stimulation of the vagus nerve will prevent/ameliorate seizures as well as~     behavioural mood symptoms in children with refractory epilepsy, characterized by the~     pro-inflammatory monocyte signature~   "
167093|NCT01378598|"~     Research has found that patients sometimes have trouble obtaining oral (by mouth) cancer~     medications, understanding how to take these pills, handling side effects related to these~     drugs, and remembering to take these medications. The purpose of this research study is to~     have direct care nurses (DCNs) in the Thoracic Oncology Program (TOP) clinic provide teaching~     and follow-up to patients starting erlotinib (using a teaching tool) and to test the~     feasibility of providing education and follow-up. This study will also evaluate if increasing~     knowledge about erlotinib helps participants manage side effects and stay on their erlotinib~     without interruptions.~   "
167094|NCT01378585|"~     The objective of this study are:~        1. To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject~        2. To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject~   "
167095|NCT01378572|"~     With the present study the investigators intend to identify the morphologic and~     electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated~     cardiomyopathy undergoing implantation of a defibrillator for the primary prevention of~     sudden cardiac death. Moreover, the investigators also aim to identify if there is any~     electrophysiological substrate modification at the time of the first arrhythmic event in~     these patients. To this aim, the investigators will prospectively correlate electroanatomic~     mapping and cardiac magnetic resonance findings with arrhythmic events, in order to identify~     substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy, who~     are therefore more likely to benefit from a defibrillator implantation. Furthermore,~     electroanatomic mapping will be repeated at the time of the first arrhythmic event and~     compared with that at baseline, in order to evaluate any electrophysiological substrate~     changes.~   "
167096|NCT01378559|"~     The purpose of this study is to assess patient satisfaction with the Titan one touch release~     penis prosthesis and to register complications with this prosthesis. This will regard the~     first prostheses inserted at Herlev Hospital/Frederikssund Hospital.~      Patient satisfaction will be assessed by mailing out the Erectile Dysfunction Inventory of~     Treatment Satisfaction (EDITS) Questionnaire and recording the patient answers. The most~     important question will be Overall how satisfied are you with penile prosthesis?.~      Complications (including infection, bleeding, and mechanical failure) will be assessed by a~     patient chart review and confirmed by a brief phone interview.~   "
167110|NCT01378377|"~     The research trial is testing the experimental drug MSC1936369B (Pimasertib) and the drug~     TORISEL, given together, in the treatment of advanced solid tumors. The primary purpose of~     the study is to determine the maximum tolerated dose and the recommended Phase II dose (RP2D)~     of the drug combination.~   "
167111|NCT01378364|"~     The aim of the study is to investigate safety, tolerability and pharmacokinetics of single~     rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to~     healthy male volunteers.~   "
167097|NCT01378546|"~     Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle~     weakness and limited reflex activity. More than half of LEMS cases are associated with a~     malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not~     coupled with malignant cells.~      3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating~     the weakness associated with LEMS as it increases strength and improves autonomic symptoms in~     LEMS patients. It is not currently approved by the FDA for use in the United States. The~     investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University~     MDA/ALS Research Center.~   "
167098|NCT01378533|"~     The purpose of this trial is to compare the 3 years DFS of dose-dense epirubicin and~     cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy~     for triple-negative breast cancer.~      The other purpose of this trial is to observe the patient's tolerance.~   "
167099|NCT01378520|"~     Beta-endorphins, which are naturally occurring narcotic substances, have been shown to alter~     the perception of breathlessness. Oral ketoconazole, an antifungal antibiotic, increases~     blood levels of beta-endorphins. The study hypothesis is that oral ketoconazole will reduce~     ratings of breathlessness induced by resistive breathing loads.~   "
167100|NCT01378507|"~     Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of~     endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The~     purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.~   "
167101|NCT01378494|"~     Utilizing an extremely well-characterized HIV cohort under observation as ART-naïve or since~     their first exposure to HIV treatment, the investigators will conduct a cross-sectional study~     with prospectively collected data to determine BMD in 200 subjects. Subjects identified were~     initially treatment naïve when entering the University of Alabama at Birmingham (UAB) 1917~     HIV Clinic between 1999 and 2010; some have been under observation without being treated with~     ART therapy and others were newly started on ART therapy while under observation. For each~     subject, the investigators will determine associations between BMD and 1) cumulative viremia,~     2) ART duration, and 3) ART type.~      Hypothesis 1a: BMD will be lowest in HIV+ subjects with the highest levels of cumulative~     viremia.~      Hypothesis 1b: BMD will be greatest in HIV+ persons with longest duration of ART therapy,~     after excluding those subjects treated with tenofovir.~      Hypotheses 1c: BMD will be lower in subjects treated with tenofovir vs. other ART agents,~     after controlling for duration of therapy.~      Additionally, the investigators will conduct a retrospective study in 100 patients HIV+ and~     were ART-naïve at the time of entry into the 1917 Clinic in whom the investigators will~     longitudinally evaluate the relationship between HIV viral load, inflammation, and bone~     turnover (through the measurement of HIV copy-years viremia, interleukin-6 {IL-6}, tumor~     necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}, osteocalcin, and~     urine C-telopeptide {CTX}). The investigators will compare HIV patients at a similar stage of~     their disease who remain treatment naïve (either due to concerns for compliance or sufficient~     CD4 counts without treatment) (ART-) vs. those newly started on ART (ART+).~      Hypothesis 2: Viral load, markers of inflammation, and markers of bone resorption will all~     decrease in ART+ vs. ART- persons.~   "
167102|NCT01378481|"~     This study is being done to determine if an investigational cancer treatment called~     vorinostat combined with fractionated stereotactic radiation therapy (FSRT) is effective in~     treating recurrent high grade gliomas. The main goal of this research study is to determine~     the highest dose of vorinostat that can be given to patients with recurrent tumors. The study~     will also determine the potential side effects and safety of these treatment combinations.~     Vorinostat is a small molecule inhibitor of histone deacetylase (HDAC). HDAC inhibitors help~     unravel the deoxyribonucleic acid (DNA) of the cancer cells and make them more susceptible to~     the treatment with radiation.~   "
167103|NCT01378468|"~     Non-fasting triglyceride levels are thought to play a role in stroke. The investigators~     hypothesise that the results of a standardised oral triglyceride tolerance test in the~     subacute setting (3-7 days) after the first ischaemic stroke are associated with the risk of~     recurrent stroke within 12 months after the index event.~   "
167104|NCT01378455|"~     Visual perception impairment and upper limb disability will affect the handwriting~     performance. Children with cerebral palsy (CP) who have good function on upper extremity may~     associated with visual perception impairment, which will impact the handwriting performance.~     However, there were few studies to investigate the handwriting problems in children with CP~     who have good upper limb functions. To date, there are no studies to investigate the~     effectiveness of computerized handwriting training programs on handwriting performance in~     children with CP. The aims of this study were to establish the relationships of visual~     perception, visual motor integration, and motor coordination of handwriting performance in~     children with typical development (TD) in Taiwan, to establish the norms of handwriting~     performance in children with TD in Taiwan, to compare handwriting performance in children~     with CP and children with TD, to clarify the relationship of visual perception function and~     handwriting performance in children with CP, and to examine the effectiveness of interactive~     computerized handwriting training program (ICHTP) on handwriting performance in children with~     CP.~      The investigators will collect 90 children with TD and 48 children with CP in the 1st phase.~     All children will receive clinical and Chinese handwriting assessment tool (CHAT)~     assessments. The CHAT and ICHTP will be modified as Taiwan-version handwriting assessment~     tool and training programs for children in Taiwan, respectively. Clinical assessments include~     the visual perception, visual motor integration, fine motor skill, and handwriting~     performance. The CHAT assessed the handwriting legibility, accuracy, pen pressure and writing~     speed. In the 2nd phase, the investigators will collect 48 children with CP, who were~     randomly classified into ICHTP group and Traditional Handwriting Training Program (THTP). All~     children with CP will receive clinical and CHAT assessments before and after interventions.~      The expected results of this study are the visual perception function is related to~     handwriting performance in children with CP, and the improvements in the handwriting~     legibility, accuracy, pen pressure and writing speed of ICHTP training group are greater than~     THTP training group.~   "
167105|NCT01378442|"~     In the first year, all subjects received clinical assessments include subjective assessment,~     basic data, nutritional status and fitness assessments. Laboratory assessments include body~     composition, bone density(lumbar spine and femur by dual energy X-ray absorptiometry ), bone~     strength (by calcaneal ultrasound) and bone metabolism.~      In the 2nd year, were randomized into three groups. The high level training group (20~     children) will receive high frequency fitness training program(Frequency: three times one~     week, Duration: thirty minutes). The low level training group (20 children) will receive low~     frequency fitness training program(Frequency: two times one week, Duration: thirty~     minutes).The control group (20 children) will not receive fitness training program but~     maintain the usual life style.~      In the 3rd year, all subjects received post-training clinical assessments include subjective~     assessment, basic data, nutritional status and fitness assessments. Laboratory assessments~     include body composition, bone density(lumbar spine and femur by dual energy X-ray~     absorptiometry ), bone strength (by calcaneal ultrasound) and bone metabolism.~      These data provided in this study could establish the bone quality and fitness data of~     children with diplegic CP, and provide us to plan treatment strategies in the management of~     bone and fitness problems in the future.~   "
167106|NCT01378429|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety~     study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered~     once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of~     PAR.~   "
167107|NCT01378416|"~     The purpose of this study is to determine the pharmacokinetics (PK) of decitabine~     administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).~   "
167108|NCT01378403|"~     Schizophrenia patients in comparing to normal controls show decreased ability to identify~     objects with decreased level of fragmentation, a task that is associated with magnocellular~     pathway function.~   "
167114|NCT01378325|"~     Rapid administration of crystalloid immediately after induction of spinal anesthesia (coload)~     to be more effective in terms of managing hypotension as compared to administering~     crystalloid before spinal anesthesia (preload).~      Phenylehrine infusion is a safe and effective way to reduce incidence and frequency of~     hypotension during SA for cesarean delivery. Hypotension was virtually eliminated by use of~     high-dose prophylactic phenylephrine infusion at a rate of 100 µg/min and rapid crystalloid~     coload up to two liters (administration at the time of SA). However, incidence of reactive~     hypertension was frequent up to 47% with decrease in maternal heart rate (HR). This may raise~     concern in patients in whom increase of blood pressure may be detrimental, like chronic~     hypertension and in the presence of a compromised uteroplacental blood flow. A recent study~     found that infusing phenylephrine at a fixed rate of 75 and 100 ug/min is associated with~     more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ug/min~     respectively. However, there was no reduction in the number of physician interventions~     (phenylephrine boluses and stopping the infusion) needed to maintain maternal systolic blood~     pressure within 20% of baseline among all groups. Prophylactic fixed rate infusions may have~     limited application in clinical practice, and a variable rate (i.e. modifying the rate~     according to hemodynamics) has been advocated. The bolus administration of phenylephrine to~     treat hypotension is still commonly used, but requests multiple interventions from the~     anesthesiologists and is time consuming.~      Eighty patients scheduled for cesarean delivery under spinal anesthesia will be assigned to~     one of two groups. Immediately after spinal injection, rapid crystalloid colaod of lactated~     Ringer of 15 mL/kg over a period of 10-15 min will be initiated. Patients in Group I will~     receive infusion of normal saline (placebo) and patients in group II variable infusion rate~     of phenylephrine started at 0.75 ug/kg (close to the dose of 50 ug/min recommended for fixed~     infusion rate). The number of interventions needed to maintain maternal systolic blood~     pressure within 20% of baseline, hemodynamic performance, intraoperative nausea and vomiting,~     and umbilical cord blood gases will be compared between the two groups.~      We will define a reliable and safe method to ensure maternal hemodynamic stability during~     spinal anesthesia for cesarean delivery with the least physician interference.~   "
167115|NCT01378312|"~     This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study~     in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of~     tuberculosis infection. The study will be conducted at one clinical research site in India.~      The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete~     protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or~     booster, while not toxic, does not provide much additional protection. AERAS-402 presents~     tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine~     that may increase T cell-mediated immunity and thus protection from tuberculosis. Since~     BCG-vaccinated individuals are the population for which AERAS-402 might be indicated,~     AERAS-402 will be administered to individuals already vaccinated with BCG.~   "
167116|NCT01378299|"~     Testosterone (T) replacement prevents bone loss and relieves symptoms associated with~     androgen deficiency in male patients with hypogonadism, but at the expense of an increase in~     prostate-related adverse events and in the hematocrit values above the normal which may lead~     to bad circulatory outcomes. Most of the effects of T on the male skeleton are mediated by~     its conversion to estradiol (E2) by the enzyme aromatase. Genetic variations in the aromatase~     (CYP19A1) gene result in enzymes with variable activity and variable levels of E2 and T. This~     project is designed to determine if genetic variations in the CYP19A1 gene will result in~     differences in the skeletal response and incidence of side effects from T treatment in~     patients with low T. A large number of male Veterans are on T. Results from this project will~     help identify patients who would benefit from the therapy from those at risk for side~     effects, and would definitely have an impact in the future care of these patients and male~     patients in general once genetic profiling becomes part of the standard of care.~   "
167117|NCT01378286|"~     Primary Objective:~      - To demonstrate the non-inferiority of corrected adequate clinical and parasitological~     response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine~      Secondary Objectives:~        -  To assess the non inferiority on the same way as the main criteria:~        -  at Day 28 before corrected cure rate~        -  at Day 14 and Day 42 before and after corrected cure rate~        -  To compare the two groups of treatment in terms of:~        -  Efficacy:~             -  Proportion of aparasitaemic patients at 24, 48 an 72 hours~             -  Proportion of afebrile patients at 24, 48 and 72 hours~             -  Percentage of gametocyte carriers during follow-up~             -  Evolution of the mean of gametocytes during the 42 days of follow-up~             -  Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28~        -  Clinical and biological tolerability:~             -  Proportion of any adverse event~             -  Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells,~               neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino~               transferase/ALT), bilirubins)~             -  ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old~               and above~   "
167118|NCT01378273|"~     Recombinant human erythropoietin (Epo) is a promising novel neuroprotective agent. Epo~     decreases neuronal programmed cell death resulting from brain injury; it has~     anti-inflammatory effects, increases neurogenesis, and protects oligodendrocytes from injury.~      We hypothesize that neonatal Epo treatment of ELGANs will decrease the combined outcome of~     death or severe NDI from 40% to 30% (primary outcome), or the combined outcome of death plus~     moderate or severe NDI from 60% to 40% (secondary outcome) measured at 24-26 months corrected~     age.~        1. To determine whether Epo decreases the combined outcome of death or NDI at 24-26 months~          corrected age. NDI is defined as the presence of any one of the following: CP, Bayley~          Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Scale < 70~          (severe, 2 SD below mean) or 85 (moderate, 1 SD below mean). CP will be diagnosed and~          classified by standardized neurologic exam, with severity classified by Gross Motor~          Function Classification System (GMFCS).~        2. To determine whether there are risks to Epo administration in ELGANs by examining, in a~          blinded manner, Epo-related safety measures comparing infants receiving Epo with those~          given placebo.~        3. To test whether Epo treatment decreases serial measures of circulating inflammatory~          mediators, and biomarkers of brain injury.~        4. To compare brain structure (as measured by MRI) in Epo treatment and control groups at~          36 weeks PMA. MRI assessments will include documentation of intraventricular hemorrhage~          (IVH), white matter injury (WMI) and hydrocephalus (HC), volume of total and deep gray~          matter, white matter and cerebellum, brain gyrification, and tract-based spatial~          statistics (TBSS based on diffusion tensor imaging). As an exploratory aim, we will~          determine which of the above MRI measurements best predict neurodevelopment (CP,~          cognitive and motor scales) at 24-26 months corrected age.~      Anticipated outcomes: Early Epo treatment of ELGANs will decrease biochemical and MRI markers~     of brain injury, will be safe, and will confer improved neurodevelopmental outcome at 24-26~     months corrected age compared to placebo, and will provide a much-needed therapy for this~     group of vulnerable infants.~   "
167119|NCT01378260|"~     The specific aim of this study is to prospectively compare outcomes (functional, quality of~     life, risk-adjusted clinical event) of medical management, surgical or endovascular~     (angioplasty or stent placement) interventions for the treatment of claudication caused by~     peripheral arterial disease. This study will test two major hypotheses;~      Hypothesis 1: At 12-months, surgical interventions are associated with greater improvements~     in function, claudication symptoms, and health-related quality of life (HRQoL) than~     endovascular procedures or medical management.~      Hypothesis 2: At 12-months, surgical and endovascular interventions are associated with~     greater improvements in function, claudication symptoms, and HRQoL than medical management.~   "
167120|NCT01378247|"~     The purpose of this study is to determine whether Family Focused Nursing are effective in the~     treatment of heart failure outpatients with respect to health-related quality of life.~   "
167121|NCT01378234|"~     The Enhanced Discharge Planning Program (EDPP) is an intervention designed to help older~     adults safely transition to the community after discharge. This is achieved through~     telephonic care coordination facilitated by social workers. EDPP social workers ensure full~     implementation of the discharge plan, assist with coordinating community resources and~     follow-up appointments, and intervene around other issues that may arise as a result of a~     complex transition.~      The EDPP intervention is currently being offered to some older adult patients discharged from~     Rush University Medical Center. Case managers refer older adult patients on selected units~     who they believe may be at risk for adverse events post-discharge. While this service is~     being provided to patients, it has not yet been formally evaluated. This randomized~     controlled trial will provide data necessary for a more rigorous evaluation of the efficacy~     of this intervention.~   "
167122|NCT01378221|"~     Advanced age is associated with an increase in postoperative morbidity and mortality in~     cardiac surgery patients. In detail, compared with younger patients those aged 75 years and~     older have significantly higher rates of in-hospital mortality, cerebrovascular events,~     pneumonia, and dialysis. In addition, older cardiac surgery patients have longer mechanical~     ventilation times. Vitamin D exerts several beneficial effects on the cardiovascular system.~     Moreover, it has immuno-modulatory and anti-inflammatory properties. The hormonal form of~     vitamin D, 1,25-dihydroxyvitamin D, is an independent predictor of mid-term mortality in~     cardiac transplant recipients. 1,25-dihydroxyvitamin D also predicts mid-term and long-term~     mortality in patients with a high risk for cardiovascular disease. Mild renal impairment,~     insufficient vitamin D levels, and secondary hyperparathyroidism are common in frail elderly~     individuals. The present study aimed to investigate whether cardiac surgery exerts~     age-dependent effects on calciotropic hormones, components of the immune system, and~     inflammatory processes.It is hypothesized that (i) baseline 1,25-dihydroxyvitamin D levels~     are lower in patients <= 75 years of age compared to younger patients, (ii) cardiac surgery~     results in a transient decrease in circulating 1,25-dihydroxyvitamin D, and (iii) that the~     decrease in 1,25-dihydroxyvitamin D is probably more pronounced in older than in younger~     cardiac surgery patients.~   "
167123|NCT01378208|"~     The Danish Food Administration recommends eating three main meals and three small meals a day~     in order to maintain a healthy lifestyle. However, there is little research to support this~     concept- moreover, many studies shows that fasting can have a positive impact on our health.~      HYPOTHESIS AND PURPOSE The investigators hypothesize, that the number of meals per day in~     order to maintain a healthy lifestyle will not differ in normal weight subjects.~      The investigators will include 1) healthy, normal weight subjects. The investigators will~     study the effects of two daily meals.~      More specifically, the investigators want to better understand how the body reacts to~     long-term, intermittent fasting (14 h /day for 4 weeks). The investigators will assess~     cognitive function, dietary intake, appetite regulation, fitness, glucose and insulin~     responses, as well as fat and muscle composition of the body before, during, and after the~     study.~      Our long-term goals are to compare the effects of intermittent fasting with acute fasting.~     All of this is in an effort to establish how our eating habits ultimately affect our health~     and to, perhaps, contribute to new recommendations for healthy eating in normal weight~     population.~      BACKGROUND Obesity and diabetes are increasing health threats facing the Western world today,~     despite abundant research efforts and campaigns to prevent such outcomes. Throughout the~     years, as the incidence of both obesity and diabetes in the general population has increased,~     so too has the typical number of daily meals. A once common three meals per day has now~     increased to six meals per day, in many instances. Recent animal research has shown that~     intermittent fasting (one or two meals per day) over a long period of time can improve~     cardiovascular health and prevent chronic diseases. Biochemically, fasting leads to an~     activation of metabolic mechanisms designed to preserve carbohydrates and increase the~     dependence on energy produced by the metabolism of fat. There is little scientific evidence~     regarding the number of meals per day that proves to be the healthiest, and those studies~     that do exist have opposing conclusions. Several theories do exist regarding the number of~     meals per day that affect us in the most favorable way, but these are just theories. Our~     study is the first to assess, in both a systematic and controlled setting, how long-term,~     intermittent fasting affects the human body.~   "
167124|NCT01378195|"~     Photozig and Stanford University are creating a program to help cope with caregiving,~     alleviate related stress, and enhance quality of life for caregivers, with funding from the~     National Institute on Aging. This home-based program includes a free DVD, printed materials,~     and resource website. In addition, after completing the program, participants will have free~     access to final online resources for 1 year. There are no face-to-face meetings, and~     participants can live anywhere in the United States.~   "
167125|NCT01378182|"~     Wilson's disease is an autosomal recessive genetically inherited disorder of copper~     metabolism, causing neurological, psychiatric and liver disease. The ATP7B gene on the 13th~     chromosome is responsible for the disease. Liver has a critical role on copper metabolism. It~     is the main site of copper accumulation and bile secretion is the only physiologic way of~     copper elimination. Due to defective production of ceruloplasmin which carries copper, wide~     amount of free copper precipitates throughout the body but particularly in the liver, eyes~     and brain. Patients are bound to lifelong chelating agents such as penicillamine, trientine~     and tetramine dihydrochloride. Unfortunately, these medications may cause severe side-effects~     such as hypersensitivity reactions, bone marrow suppression, auto-immune disease and~     sideroblastic anemia. Medical treatment of liver cirrhosis, the last stage of the illness~     that leads to morbidity and mortality in the Wilson Disease, is difficult. Liver~     transplantation is still the most effective treatment for the patients with liver cirrhosis~     in Wilson Disease. However, serious problems are accompanied with liver transplantation. Lack~     of liver donors, complications during and after the surgery, graft rejection and high costs~     are the main problems.~      There are cells in the human body that are capable to renew themselves and differentiate to a~     diverse range of specialized cell types. These are called stem cells. Stem cells can be~     differentiated to specialized cells in appropriate medias in the laboratory. Recently, the~     differentiation potential of mesenchymal stem cells into hepatocytes is proved by~     demonstrating hepatocytes containing Y chromosome in the female who has had bone marrow~     transplantation from male donors. In many laboratory studies, it is observed that human bone~     marrow derived mesenchymal stem cells, transplanted to animals with induced liver damage,~     differentiate into the albumin producing hepatocytes without fusion. By these studies, it is~     understood that mesenchymal stem cells are more potent than other bone marrow elements in~     context of differentiation to hepatocytes. Even though the number of studies on human for the~     same purpose is few, findings are supporting those of animal experiments. Mesenchymal stem~     cells are non-immunogenic. Safety and feasibility of allogeneic transplantations between~     individuals without need of immunosuppressive drug regimen are proven. Proofs of correcting~     metabolic defects by this way are also presented in some publications. For the reasons~     mentioned above, allogeneic mesenchymal stem cell transplantation is a promising treatment~     modality especially for the hereditary metabolic diseases. By this way, non-immunogeneic~     mesenchymal stem cells which have healthy genetic structure, can manufacture the required~     enzyme, will be repopulated in the damaged tissue and contribute to the clinical improvement.~      In this study, mesenchymal stem cells will be derived from healthy volunteer donor's bone~     marrow and be expanded in-vitro, and then 1 million cells per kg will be infused to patients~     with liver cirrhosis related to Wilson disease, 50 million cells via hepatic artery and the~     remaining cells via peripheral vein. It is aimed to enable liver regeneration, decrease~     fibrosis rate, improve patient's health conditions, increase ceruloplasmin synthesis,~     ameliorate disorder of copper metabolism, decrease the need for chelating agents, increase~     living standards of patients, and prolong waiting time for liver transplantation. Finally it~     is aimed to establish a new and regenerative treatment protocol alternative to liver~     transplantation. For observation of clinical and laboratory improvement, patients are planned~     to be monitored by histopathologic examination of liver biopsies before and at 6th month~     after the treatment, monthly biochemical and hematologic blood tests and periodic radiologic~     examinations. This is a hopeful, avant garde and sophisticated study which may constitute new~     horizons in context of cellular therapies.~   "
167126|NCT01378169|"~     Aim of the study : The primary aim of the investigators study is to highlight the presence of~     biomarkers (biological indicators of the presence of inflammation or infection) of infectious~     processes during the systemic inflammatory response (SIRS) allowing, first to discriminate~     non-infectious inflammation from infectious processes and secondary to determine the~     microbial pathogen responsive of the infection. For this purpose the investigators will~     conduct a combinatorial approach of several blood markers including usual markers of~     inflammation and other blood and cells markers. Expression of small pieces of RNA (miRNA)~     known to inhibit determined gene expression, will also be analysed in monocytes (a specific~     group of white blood cells involved in the fist line of defences against microbes.~      Study design : For this purpose the investigators will include 300 patients admitted to the~     intensive care unit with suspicion of infection. Serial blood sample will be take for~     biological parameters analysis. Efficiency of each single parameters and of different~     combinations of different markers to determine the presence or absence of infection~     responsive of clinical inflammation will be studied.~   "
167127|NCT01378156|"~     GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia~     who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test.~     This study has 3 phases. The first phase is the vaccination phase, where patients are~     vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen. The second~     phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12~     week period approximately 8 weeks following the last vaccination. The third phase occurs~     after the 12 week treatment interruption phase and is called the treatment reinstitution~     phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The~     primary objective is to evaluate the safety of the vaccines during the three phases of the~     study. A secondary objective is to evaluate the immunogenicity of the vaccines during the~     vaccination phase of the study.~   "
167128|NCT01378143|"~     The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS~     in combination with standard of care as a second line treatment in subjects with unresectable~     and locally recurrent or metastatic colorectal cancer.~   "
167220|NCT01376908|"~     This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate~     efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in~     less than 4 year-old infants and children with phenylketonuria (PKU).~   "
167130|NCT01378117|"~     High blood glucose levels in hospitalized patients with diabetes are associated with~     increased risk of medical complications and death. Improved glucose control with insulin~     injections may improve clinical outcome and prevent some of the hospital complications.~     Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the~     hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose, but has not been~     tested in the hospital. It is not known if sitagliptin is as effective in controlling blood~     sugars in the hospital. This study will compare sitagliptin by mouth, insulin (glargine)~     injection, and the combination of sitagliptin and lantus insulin in controlling blood sugar~     in hospitalized patients with diabetes.~      In this pilot study, patients with known history of diabetes treated with diet and/or OAD or~     with low total daily dose insulin therapy (<0.4 unit/kg/day) will be randomized to receive~     sitagliptin once daily (group 1), sitagliptin plus basal (glargine) insulin once daily (group~     2), or basal bolus regimen with glargine once daily and lispro insulin before meals (group~     3). If needed, patients in the 3 treatment groups will receive correction doses of~     rapid-acting lispro (Humalog®) insulin in the presence of hyperglycemia (BG > 140 mg/dl) per~     sliding scale. The overall hypothesis is that treatment with sitagliptin once daily alone or~     in combination with basal insulin in patients with type 2 diabetes will result in a similar~     improvement in glycemic control and in a lower frequency of hypoglycemic events than~     treatment with basal bolus insulin regimen with glargine once daily and lispro insulin before~     meals.~      A total of 90 subjects with type 2 diabetes will be recruited in this study. Patients will be~     recruited at Grady Memorial Hospital and Emory University Hospital.~   "
167131|NCT01378104|"~     1. Randomized controlled multicenter study~        2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis~          C genotype 1~        3. IL28B polymorphism in Koreans with CHC~   "
167132|NCT01378091|"~     Primary objectives:~      To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given~     every three weeks and prednisone, as combination therapy to subjects with androgen~     independent prostate cancer~      To evaluate the safety profile of the combination of daily lenalidomide and every three week~     docetaxel and prednisone when given to subjects with androgen independent prostate cancer~      Secondary objective:~      To explore the anti-tumor activity of the combination of daily lenalidomide and every 3 week~     docetaxel and prednisone when given to subjects with androgen independent prostate cancer.~   "
167133|NCT01378078|"~     Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in~     healthy subjects and depressed patients. In this study, patients with treatment resistant~     negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI~     measures will be performed.~   "
167134|NCT01378065|"~     This is a prospective, multi-center study designed to assess the palpability of the~     Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.~   "
167135|NCT01378052|"~     Many studies previously showed the significant association between urinary arsenic profiles~     and urothelial carcinoma (UC) risk and observed the increased UC risk in people with lower~     plasma folate and higher homocysteine than those with higher plasma folate and lower~     homocysteine. The investigators would expect to explore the interactions among global DNA~     methylation, one-carbon metabolic pathway factors, urinary arsenic profiles and UC.~   "
167136|NCT01378039|"~     Asthma and chronic obstructive pulmonary disease(COPD) are common diseases, which tend to~     even increase in many countries. Both from a clinical and a pathophysiological point of view,~     this is an important issue. However, an understanding of the relationship between the complex~     array of cells and mediators involved in asthma and COPD is not yet fully dissected which~     makes difficult to find a specific and sensitive panel of biomarkers that can reflect~     intensity of these pathological processes and can help to predict the individual outcome.~   "
167137|NCT01378026|"~     G72 gene is located on the common linkage locus in bipolar disorder and schizophrenia, and it~     encodes D-amino acid oxidase activator (DAOA). There are evidences that elucidated G72 and~     D-amino acid oxidase(DAO) together playing a critical role in the pathophysiology of~     schizophrenia. Recently, reports discovered missense mutations in the DAO (R199W DAO and R38H~     DAO) are associated with familial amyotrophic lateral sclerosis (FALS), and our preliminary~     data showed that the level of G72 autoantibody decreases in patients with ALS compared with~     normal control. Thus, we want to find out whether G72 plays a role in ALS and~     neurodegenerative diseases including Alzheimer disease and Parkinson's disease. First, we~     detect G72 protein and its autoantibody in sera of neurodegenerative diseases patients using~     ELISA and Western blotting, and the data are compared with normal control. We hypothesize the~     levels of G72 protein and its autoantibody in neurodegenerative diseases are less than those~     in normal control. Then, we extract genomic DNA of neurodegenerative diseases patients, and~     use polymerase chain reaction(PCR) to detect single nucleotide polymorphism (SNP) of G72. We~     aim to detect G72 missense SNP variants presented in ALS, AD and PD.~   "
167138|NCT01378013|"~     This work will use a new approach to measure how surgery effects human biochemistry and~     metabolism. It will create a metabolic signature or 'phenotype' for surgical injury that will~     help clinicians choose the right surgical treatments for an individual. This is because~     metabolism is based on an individual's genes, disease burden and environmental influences~     such as gut microbiota. This study will use a scientific method based on computational~     analysis of spectra taken from techniques known as Mass Spectrometry (MS) and Nuclear~     Magnetic Resonance (NMR) spectroscopy. This science is called 'metabonomics' and it has many~     advantages. Firstly, it provides a measure of thousands of metabolites at a single moment in~     time that are unique to the individual and it therefore gives a 'systems' overview of a~     persons metabolism. Secondly it is able to process many hundreds of samples quickly. The~     investigators are aiming to integrate the investigators metabolic data with genetic~     information about patients or bacteria wherever possible. This will be the first time that a~     'systems biology' approach has been used in surgery, with potentially significant gains to me~     made in pre operative risk stratification and optimisation. By performing this analysis at~     all stages of the surgical journey (preoperatively, during the operation and after the~     surgery) it will ensure the right treatments are given to the right patient at the right~     time. By creating longitudinal models of the biochemical responses to surgery, predict at a~     much earlier stage those patients at risk of developing complications. This will improve~     outcome after surgery. This work will use a metabonomic approach to create new tools for~     surgeons to use during operations based on tissue biology. For example the investigators will~     be able to measure the metabolic content of tumours in real time by measuring the biological~     content of diathermy smoke. This has the potential to change intra-operative decision making~     and further improve outcome.~   "
167250|NCT01376518|"~     The aim of the present study is to characterize the influence of an elevated positive~     end-expiratory pressure in patients with acute respiratory distress syndrome or acute lung~     injury on the cerebrovascular autoregulation.~   "
167139|NCT01378000|"~     A clinical trial to study the effects of dosage, infusion methods and complications of~     unfractionated heparin (UFH) treating acute progressive cerebral infraction was conducted. In~     this study, we observed the effects of four UFH treatments on 480 acute progressive cerebral~     infraction patients during from the 6th and the 72nd hour after the attack. It was concluded~     that the ultra-slow continuous intravenous infusion of UFH can significantly reduce the~     neurological deficit score of patients with progressive cerebral infarction, increase the~     cure rate, decrease the recurrence rate, and improve long-term quality of daily life. It is~     more effective than the treatment of intravenous infusion of low- molecular- weight UFH at~     once a day, and the risk of bleeding may not necessarily be increased.~   "
167140|NCT01377987|"~     The ultimate goal is to improve our understanding of the pathophysiology and resistance to~     effective treatment of sleep disordered breathing in patients with heart failure, with a~     focus on selecting patients that will benefit specifically from acetazolamide treatment.~      The study addresses three primary hypotheses: 1) Acetazolamide treatment will reduce the~     apnea-hypopnea index and improve markers of heart-failure severity in heart-failure patients~     with sleep apnea. 2) Acetazolamide will provide the greatest improvement in patients with the~     most severe ventilatory control instability (strongest chemoreflex response to carbon~     dioxide; highest loop gain). 3) Acetazolamide will act primarily via stabilizing ventilatory~     control (reducing loop gain), rather than via improvement to upper airway anatomy, pulmonary~     congestion, and cardiac function.~   "
167141|NCT01377974|"~     The purpose of this study is to determine whether miltefosine is effective in the treatment~     of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.~   "
167142|NCT01377961|"~     Type 2 diabetes mellitus (DM2) is a growing social health problem world-wide, in particular~     with respect to its contribution to cardiovascular disease. The progressive increase in~     prevalence of DM2 has reached epidemic proportion and is a major cause of morbidity and~     mortality in all populations around the world. Conventional stepwise treatment of DM2~     generally focuses on controlling blood glucose concentration. However, the risk for~     side-effects associated with the use of pharmacological intervention often delays initiation~     of therapy, with the potential implication on worsening morbidity and mortality from~     complications. On the other hand, non-pharmacological intervention in the form of dietary~     restrictions, exercise and weight loss, is safe but often difficult to accomplish. The~     availability of nutrients that affect glucose and lipid metabolism would provide an important~     practical tool to establish early intervention in newly diagnosed DM2 and perhaps even in~     patients who are only at risk for DM2. The investigators have recently obtained preliminary~     data on beneficial effects of combined supplementation of lycopene and isoflavones on glucose~     metabolism of normoglycemic volunteers with insulin resistance. This clinical trial will~     explore the role of isoflavones and lycopene dietary supplementation in the improvement of~     glucose metabolism of patients at increased risk or with established but mild DM2. The~     overall hypothesis is that supplementation of laflavon, provided as a new formulation that~     increases bioavailability of the individual components (Laflavon CamMedica contains 7 mg of~     Lycopene and 50 mg of Soy Isoflavones), determines improvement in glucose tolerance and~     insulin resistance of patients with the metabolic syndrome and also reduces HbA1c in patients~     with mild DM2.~   "
167143|NCT01377948|"~     The purpose of this study is to determine whether Anger Control Therapy (ACT) with Regulate~     and Gain Emotional-Control (RAGE-Control) is a feasible behavioral therapy to provide on a~     pediatric inpatient psychiatric unit.~   "
167144|NCT01377935|"~     The purpose of this study is to compare the incidence of hospitalization for acute kidney~     injury among patients with type 2 diabetes who are new initiators of Saxagliptin and those~     who are new initiators of other oral antidiabetic drugs in classes other than Dipeptidyl~     peptidase IV (DPP4) inhibitors.~   "
167145|NCT01377922|"~     A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients~     with Lambert-Eaton Myasthenic Syndrome (LEMS).~   "
167146|NCT01377909|"~     Objective: The goal is to improve peginterferon sensitivity in previous poor responders.~     Sensitivity here means the host's ability to kill more HCV.~      Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin~     monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.~   "
167147|NCT01377896|"~     'Real life' retrospective patient cases (10) to provide an objective and robust analytical~     report of patient management and prescriptions behaviours for Schizophrenia, Bipolar~     disorders and Major depressive disorders.~   "
167148|NCT01377883|"~     Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin~     (BTX) injections that are administered several times a year. While clown care reduces~     preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized~     that medical clowning reduces pain and anxiety during BTX injections.~   "
167149|NCT01377870|"~     Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which~     affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter~     problems. The disease is caused by an autoimmune mechanism, ie the immune system produces~     antibodies and cells which attack the self myelin antigens, causing therefore demyelination.~     The disease is clinically evident with relapses of neurological disability due to the~     dysfunction of the areas (plaques of multiple sclerosis) in which damage of myelin occurs.~     Disability can accumulate with time and the disease enters a progressive phase due to damage~     of the axons and irreversible neurodegeneration. Although, effective immunotherapies exist~     which downregulate the autoimmune anti-myelin reactivity and reduce the rate of relapses of~     MS (like Copaxone and interferons), there is no effective means today to stop the progression~     of disability and induce rebuilding of the destroyed myelin.Adult bone marrow derived stromal~     cells (MSC) were shown to induce similar (to the neuronal stem cells) immunomodulatory and~     neuroregenerative effects and were shown in our laboratory to induce neuroprotection in the~     animal model of chronic experimental autoimmune encephalomyelitis (EAE). These bone marrow~     derived MSCs offer practical advantages for clinical therapeutic applications, since they can~     be obtained from the adult bone marrow and therefore the patient can be the donor for~     himself, without any danger for rejection of the cells. In addition, MSCs carry a safer~     profile and are less prone to malignant transformation.~      Our center will perform a clinical trial with intra venous transplantation of bone marrow~     derived mesenchymal stem cell.our purpose is to evaluate the safety and feasibility of cell~     transplantation after 1year following up.~   "
167150|NCT01377857|"~     Over twenty percent of HIV-positive persons in the United States are unaware of their~     infection, leading the Institute of Medicine to recently urge further work to compare the~     effectiveness of HIV screening strategies. This study will use a randomized trial to compare~     several variants of emergency-room-based HIV-testing policies in order to determine how HIV~     test acceptance rates can be increased. The testing policies will be designed using~     principles from behavioral economics, varying the choice architecture and offering small~     monetary incentives. This will be the first study to measure differences in take-up rates~     across a variety of promising but largely untested approaches within a unified randomized~     trial. Three defaults will be tested: traditional opt-in (test only those patients who~     request testing), opt-out (routinely testing unless patients decline), and active-choice~     testing (patients are required to state whether they want to be tested). The study will also~     be the first to test the effect of small monetary incentives ($1, $5, $10) on test take-up.~     An additional novel study contribution will be to test the hypothesis that compliance with~     large requests (accept an HIV test) increases after making a small request or pre-commitment~     - this foot in the door technique has not been previously studied in this setting. The~     factorial design will permit a direct comparison of all interventions, as well as~     interactions. The study will contribute a nuanced empirical understanding of how testing~     protocols from behavioral economics theory affect the effectiveness and efficiency of~     screening programs in an actual scaled- up setting (San Francisco General Hospital). This~     will assist in implementing and assessing recent CDC guidelines on HIV screening, while also~     more generally advancing scientific knowledge related to applying behavioral economics in~     comparative effectiveness research.~   "
167151|NCT01377844|"~     The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated~     Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels~     at 24th week from baseline, when compared to placebo group(no diabetic medication given). The~     secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting~     blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study~     assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American~     Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with~     placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures,~     body weight and compare with the respective placebo groups.This study also assess the change~     from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of~     EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).~   "
167152|NCT01377831|"~     To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer~   "
167153|NCT01377818|"~     Objective: To analyze the additional benefits of exercise training application by the~     non-invasive home mechanical ventilation in patients with stable COPD and hypercapnic~     respiratory failure. SUBJECT: moderate-severe COPD (FEV1 <60%) in chronic respiratory failure~     (hypoxemia and hypercapnia PaCO2> 45mmHg). GROUPS: 45 patients included prospectively and~     randomly into 3 groups of 15: a) training + NIPPV group, b) Group training, c) Group NIPPV.~     Hypothesis: A training program to the effort associated with treatment with NIPPV~     significantly increase the effects compared with each treatment. MAIN OBJETIVE: Effects on~     exercise capacity as measured by the test of endurance cycling and test 6-minute walk~     (distance). SECONDARY OBJECTIVES: Impact on quality of life and dyspnea, as measured by~     questionnaire and CRQ, systemic inflammatory response (CRP, IL-8, TNF-α), changes in~     peripheral muscle strength (1RM test, isometric) and effects score BODE index.~   "
167154|NCT01377805|"~     Multiple sclerosis patients commonly develop generalized ventricular dilation with or without~     cerebral atrophy over time. Case studies in the literature have noted some multiple sclerosis~     patients develop the typical normal pressure hydrocephalus triad of dementia, gait~     disturbance and incontinence which were responsive to shunts.~      Many patients with connective tissue disorders (Ehlers-Danlos Syndrome) develop Multiple~     Sclerosis and studies indicate that in the Multiple Sclerosis population, there exists over~     10% more Ehlers-Danlos patients than in the normal population.~      Because studies are indicating a form of external communicating hydrocephalus in the~     Ehlers-Danlos population, the author hypothesizes the same type of hydrocephalus may occur in~     the Multiple Sclerosis population.~      To evaluate this hypothesis, investigators will retroactively evaluate the head circumference~     of Multiple Sclerosis patients between birth and 15 months (before the skull sutures have~     closed).~   "
167155|NCT01377792|"~     A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open~     and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The~     purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10~     ml) increases the free time without pulmonary exacerbation, and if this increase is superior~     to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.~   "
167156|NCT01377779|"~     This is a prospective single blind randomized controlled pilot study was designed to~     investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of~     intrauterine adhesions following hysteroscopic treatment for retained products of conception.~   "
167157|NCT01377766|"~     The aim of this study was to explore the risk factors for Bell's palsy (BP) and to examine~     whether psychological factors are the potential risk factors for the occurrence of BP.~   "
167158|NCT01377753|"~     Background:~      - One way to treat prostate cancer is to use a laser to direct extreme heat to a small area~     of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors~     want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI~     will be used to help locate tumor cells and guide the laser during surgery. However,~     MRI-guided laser therapy has not been used to treat many people with prostate cancer. More~     studies are needed to see whether it can destroy tumor cells permanently.~      Objectives:~      - To test the safety and effectiveness of treating prostate tumors with laser therapy guided~     by magnetic resonance imaging.~      Eligibility:~      - Men at least 18 years of age who have prostate cancer that can be seen with an MRI and has~     not spread to other parts of the body.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and imaging studies, and will complete questionnaires about their~          health.~        -  Participants will have the MRI-guided laser treatment in the hospital. The doctor will~          use the MRI to control how much energy is delivered by the laser and how much tissue is~          destroyed. The entire procedure usually takes from 1.5 to 3 hours.~        -  After the treatment, participants will have a catheter put in to keep the bladder~          emptied. The catheter will stay in for 1 to 7 days. Drugs to prevent infection and~          bladder spasms will be given. Participants will leave the hospital once they are well~          enough to go home.~        -  Participants will have followup visits 3, 6, 9, 12, 18, 24, and 36 months after the~          therapy. They will have physical exams, and blood and urine tests. They will also answer~          questionnaires. Participants will have MRI scans 6, 12, 24, and 36 months after the~          therapy. They will have a prostate biopsy to see if there is any tumor every 12 months~          for the first 2 years. Another biopsy may be done in the third year.~   "
167159|NCT01377740|"~     This study is being performed to reduce unwanted abdominal fat using two different~     applicators for the Zeltiq System.~   "
167160|NCT01377701|"~     Pituitary adenomas can cause compression of optic nerves and chiasm, which will lead to~     damage of vision. This study aims to evaluate the predictive factors for recovery of vision~     in patients with pituitary adenomas following trans-sphenoidal surgery.~   "
167161|NCT01377688|"~     We propose to pilot a telehealth approach to evaluate components of risk communication by:~        1. Providing personalized tailored patient feedback to help initiate and maintain specific~          diabetic kidney disease (DKD)-related behaviors (e.g., medication adherence, weight,~          exercise, diet, smoking cessation) to reduce their risks.~        2. Evaluating how this feedback can be incorporated into clinical care by examining 6 month~          patient outcomes.~      Specific Aims are:~        1. To evaluate the feasibility and acceptability of providing both patients and their~          provider feedback on individuals' DKD risk via the telehealth intervention and~          incorporating it into regular clinical practice.~        2. If improvements in outcomes are found, to estimate the cost of the program in terms of~          the patient, provider, and overall costs of implementing the program.~   "
167162|NCT01377675|"~     This study involves the development and evaluation of a web-based, interactive education~     program on chronic obstructive pulmonary disease (COPD) for primary care clinicians.~      The research questions that this proposal addresses include:~        1. Can an interactive, web-based COPD course be developed to disseminate evidence-based,~          best practice recommendations to primary care clinicians?~        2. Can assessment tools be developed to evaluate the impact of the program on clinician~          behavior in clinical practice and on patient care?~   "
167163|NCT01377662|"~     The main purpose of this study is to determine the outcome of a drug combination treatment on~     detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users. The~     combination regimen consists of oral administration of a generic immediate-release~     methylphenidate (MPh-IR) formulation (e.g., Ritalin®) and a novel delayed, pulsatile-release~     formulation of the antiemetic ondansetron (Ond-PR002). Various psychological assessment tools~     and functional magnetic resonance imaging (fMRI) will be used to assess the treatment~     outcome. In addition to the treatment outcome measures, we will determine whether the 14-day,~     once-a-day treatment leads to significant changes in the pharmacokinetic/pharmacodynamic~     (PK/PD), safety and tolerability parameters of MPh-IR and/or Ond-PR002 formulations and~     drug-drug interactions between the two drugs.~   "
167164|NCT01377649|"~     Contrast ultrasound is a technique that can quantify blood flow in the tissues of the body by~     ultrasound detection of microbubble contrast agents that behave in the circulation similar to~     red blood cells. In this study, the investigators hypothesize that contrast ultrasound of~     blood flow in the leg (thigh and calf) at rest and during stress produced by medications that~     mimic exercise (vasodilator stress) can provide information on the location and severity of~     peripheral vascular disease (blockages of the blood vessels in the leg). The investigators~     will also determine whether symptom improvement after revascularization (procedures to open~     up or bypass the blockages) is directly related to the improvement in blood flow.~   "
167165|NCT01377636|"~     Isoproterenol is used as a cardiac stimulant in electrophysiology studies (EP). Preliminary~     data suggests that administration of isoproterenol increases the Bispectral index (BIS). BIS~     is used to monitor neuronal signals under anesthesia. The BIS level is suggested to~     correspond to the level of consciousness. We hypothesize that isoproterenol increases BIS~     values because it increases the patient's level of consciousness through its central nervous~     system (CNS) stimulatory effects. In this study, we will administer increasing doses of~     isoproterenol to EPS patients. We will measure the BIS levels continuously before and after~     isoproterenol administration. In addition, we will test the level of awareness of patients by~     their response to a modified isolated forearm technique.~   "
167166|NCT01377623|"~     The aim of the proposed study is to examine the effect of DEX on the inflammatory response in~     major surgery. More importantly, the investigators will correlate changes in the~     concentration of inflammatory mediators with meaningful clinical outcomes.~   "
167167|NCT01377610|"~     The investigators will randomize 210 opioid-dependent participants to one of two outpatient~     detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper~     from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single~     administration of a Vivitrol injection: at Day 8 for the naltrexone induction group and Day~     15 for the buprenorphine group. The naltrexone arm is a modification of our current inpatient~     naltrexone induction procedure, consisting of a single day of buprenorphine followed by a~     washout day and 4 days of ascending oral naltrexone doses, prior to administering a dose of~     injectable naltrexone on Day 8. All participants will receive an intensive behavioral therapy~     for five weeks and will be followed for the subsequent 8 weeks to assess the longer-term~     outcome of the initial treatment. The primary outcome will be percentage of patients in each~     group successfully inducted onto Vivitrol. Key secondary outcomes will be 2-week abstinence~     at Weeks 4-5 (3rd and 4th weeks after Vivitrol injection), rates of completion of the 8-day~     detoxification, and percentage of patients in each group who return for additional Vivitrol~     injections in post-study follow-up. The main goal of this Stage 1a pilot study is to develop~     an improved outpatient opioid detoxification strategy, with particular relevance to newly~     diagnosed heroin addicts and prescription opioid abusers not seeking long-term agonist~     maintenance.~      Specific Aim #1: To develop procedures for outpatient opioid detoxification which include~     naltrexone to facilitate detoxification.~      Specific Aim #2: To compare injectable naltrexone induction rates between the naltrexone and~     buprenorphine groups following short-term outpatient opioid detoxification approach for~     initiating treatment for opioid dependence.~   "
167168|NCT01377597|"~     The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly~     intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment~     due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the~     applicability of the phase III study results of BRAVO and CRUISE in this indication, in the~     Japanese ethnic patients.~   "
167169|NCT01377584|"~     The purpose of this research study is to examine the effect of a couple-oriented education~     and support intervention on patient- and partner -reported outcomes (positive airway pressure~     (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).~   "
167170|NCT01377571|"~     The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced~     by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in~     Vietnam. In addition, we evaluate different dosages and schedules to determine the best~     regimen to test in a clinical trial.~   "
167171|NCT01377558|"~     The purposes of the study are~        -  to determine which kind of supervised exercise intervention (aerobic endurance training~          versus strength endurance training versus combined aerobic endurance and strength~          endurance training) is more effective in improving the metabolic parameters in typ 2~          diabetes patients~        -  to investigate what kind of intervention is more successful in reduction of concomitant~          diseases and improving quality of life~        -  to assess what kind of intervention induces highest effects in long term persistence of~          these positive changes~   "
167172|NCT01377545|"~     The investigators propose to test the hypothesis that when placing a perineural catheter for~     a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the~     insertion needle results in a faster-onset sensory block than injecting the initial bolus via~     the perineural catheter. The study results will help define the optimal local anesthetic~     bolus introduction technique—needle versus catheter—for peripheral nerve blocks when placing~     a perineural catheter.~   "
167173|NCT01377532|"~     This is a compassionate use protocol to allow palliative therapy for patients with malignant~     pheochromocytoma and paragangliomas.~   "
167174|NCT01377519|"~     This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved~     treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis~     is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham~     MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic~     uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1~     ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants~     will remain blinded to their group assignment for 3 months. After 3 months, participants will~     be told their treatment group and those assigned to the sham group will be offered~     complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate~     candidates for a 3 month delay in fibroid treatment, such as those with significant anemia.~     The investigators will assess the change from baseline to 1 and 3 months after treatment in~     fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.~   "
167175|NCT01377506|"~     Obesity is a major public health problem among older adults, with 31% of~     non-institutionalized older persons (60 years+) in the US obese and projections indicating~     that this will rise to 40% by 2010. A second public health challenge on the horizon for the~     aging US population is the increasing number of individuals experiencing cognitive decline,~     dementia or Alzheimer 's disease. Recent clinical trials have demonstrated efficacy in~     reducing risks associated with both of these significant and increasingly pervasive health~     problems, which are more common among rural, low income and ethnic minority populations. The~     Diabetes Prevention Program (DPP) Lifestyle Intervention produced sustained weight losses in~     a large, diverse population of high-risk individuals and dramatically reduced rates of type 2~     diabetes onset, particularly among older adults. SeniorWISE produced improvements in memory~     in community dwelling older persons. Transferring these exciting technologies to community~     settings where they can benefit older adults is a pressing public health need. Therefore, the~     current project seeks to transfer these two evidence-based interventions to older adults in a~     rural state using senior centers as the venue for dissemination and lay health educators to~     deliver the interventions. Senior centers are a particularly attractive context for~     translation of evidence-based health promotion technologies in predominantly rural states~     like Arkansas because they have a well-established infrastructure in communities and share a~     common goal of promoting healthy aging and reducing health care costs. The 3-year randomized,~     controlled trial will evaluate translation of the interventions by randomizing senior centers~     (N=16) across Arkansas to implement either (1) the DPP Lifestyle Weight Loss Program or (2)~     the SeniorWISE Cognitive Training Program. Older (age > 60) adults (N=288) nested within~     senior centers will receive the programs delivered in a group format by a trained lay health~     educator. Primary outcomes are changes in body weight and cognitive functioning at 12 months.~     The multi-level evaluation plan will characterize reach, effectiveness, adoption,~     implementation and maintenance of the interventions, with a cost effectiveness component.~   "
167176|NCT01377493|"~     There were no differences in the degree of enamel remineralization of subsurface lesions~     among the chewing gums containing or not containing POs-Ca and fluoride.~   "
167177|NCT01377480|"~     This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of~     asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg~     twice daily improves therapeutic response compared to placebo in participants with a~     diagnosis of asymptomatic chronic Chagas disease.~   "
167178|NCT01377467|"~     The primary objective of the study is to examine the effect of denosumab on lumbar spine bone~     mineral density (BMD) after one year of treatment in newly transplanted renal allograft~     recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck,~     changes in body height, changes in bone mineral metabolism parameters, incidence of~     fractures, and allograft function at one year. Safety measurements include the occurrence of~     rejection episodes, infectious complications, graft loss and mortality.~        -  Trial with medicinal product~   "
167179|NCT01377454|"~     The purpose of this pilot project is to determine whether using one inertial sensor on the~     waist during routine clinical balance testing (i.e. Balance Error Scoring System (BESS)),~     will be a more immediate, objective, reliable and sensitive way to measure and quantify~     balance deficits in individuals with mild Traumatic Brain Injury (mTBI).~   "
167180|NCT01377441|"~     The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has~     not been studied extensively. Subjects are being asked to participate in this study because~     they are scheduled for surgery and because the investigators want to study ways to improve~     recovery from surgery. Ibuprofen will be given several times before and after surgery. The~     investigators will ask questions to determine recovery and the investigators will draw blood~     to determine inflammatory response.~   "
167181|NCT01377428|"~     The study will be a 12 week treatment (84 days), parallel group, randomized, double blind,~     double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol~     (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).~      Patients will be enrolled after giving informed consent and then begin a screening/run-in~     period for 14 days. Patients will be randomized to one of two treatment groups using an~     allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to~     formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of~     12 weeks.~   "
167182|NCT01377415|"~     The investigators wanted to re-evaluate the effects of subacromial bupivacaine infusion after~     shoulder arthroscopy with standard surgical techniques, including rotator cuff operations.~     The investigators hypothesized that patients having 5.0 mg/ml bupivacaine infusion at a rate~     of 2 ml/h subacromially would need less opioids than patients receiving a placebo infusion.~   "
167251|NCT01376505|"~     This phase I trial studies the side effects and best dose of vaccine therapy in treating~     patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined~     with tumor cells may help the body build an effective immune response to kill tumor cells.~   "
167183|NCT01377402|"~     The first aim of this trial is to assess the long-term prognostic value of Omega-3 index,~     which is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to~     other fatty acids in the erythrocyte membrane, in an unselected, regional multicenter~     observational study of 982 chest pain patients admitted to the emergency unit, employing~     blood samples collected at admission.~      The second purpose of this study is to evaluate the prognostic utility of vitamin D in the~     same population.~      The third purpose of this study is to assess the incremental prognostic value of B-type~     natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP).~   "
167184|NCT01377389|"~     The goal of this clinical research study is to learn if ipilimumab in combination with either~     Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect~     prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also~     want to learn if these drug combinations affect the body's immune system. The safety of these~     drug combinations will also be studied.~   "
167185|NCT01377376|"~     The primary objective of this study is to determine if the combination regimen of ARQ 197~     with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in~     subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have~     received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.~   "
167186|NCT01377363|"~     This is a Prospective Clinical Trial without drugs, to determine the HER2 status in the~     metastasis of patients with primary breast cancer HER2. 236 patients have been recruited and~     32 Sites have been taking part in this Clinical Trial.~      Primary Objective:~        -  To determine prospectively the probability of stage HER2 conversion between the~          different subtypes of primary breast cancer (luminal, triple negative and HER2) and~          their metastasis.~      Secondary Objective:~      - To determine the probability of changes in ER and PR between different subtypes of primary~     breast cancer and their metastasis.~        -  Analyze the variability in the measurement of HER2, ER and PR between local laboratories~          and central laboratory.~        -  Evaluate HER2 conversion rate compared to previously received treatment.~        -  Evaluate whether the location of metastasis biopsied relates to the probability of~          conversion of HER2.~        -  Compare the disease-free survival (DFS) and survival post relapse (SPR) of patients with~          or without conversion of HER2 and ER/PR.~        -  Compare the response rate (RR) and time to progression (TTP) for subsequent anti-tumor~          treatment of patients with or without conversion of HER2.~        -  Analyze the extent to which discrepancies in the HER2 receptor status, ER and PR between~          the primary tumor and metastasis alter the clinical management of patients.~        -  Analyze the feasibility of performing biopsies.~        -  Evaluate whether the HER2 status conversion really is associated with activation of~          intracellular markers of the HER2 signaling pathway: pMAPK, PERK, pAKT, PTEN, PIGF-1R in~          paired samples (primary tumor and their metastasis).~        -  Check if there is any change in the molecular subtypes (luminal, triple negative, HER2)~          between primary tumors and metastases in patients with HER2 conversion.~   "
167187|NCT01377350|"~     The purpose of this study is to explore the feasibility of monitoring hemodynamic changes,~     which result from heart failure exacerbations, by recording the respiratory effort, chest~     wall dynamics and quantifying the development of dyspnea by using miniature mechanical~     sensors that are attaches to the chest.~   "
167188|NCT01377337|"~     Out-of-hospital cardiac arrests (OHCA) account for over 60% of deaths from coronary artery~     disease. The annual incidence of OHCA treated by Emergency Medical Systems (EMS) is 41-89 per~     100,000 population. Outcome of OHCA and cardiopulmonary resuscitation (CPR) is very poor:~     Less than 1/3 of the victims regain spontaneous circulation (ROSC), 40-60% of those achieving~     ROSC suffer significant neurological disability due to brain hypoxia and only 1.7-6.4% are~     discharged from the hospital. In order to minimize hypoxia time, the primary goal of CPR is~     to achieve return of spontaneous circulation (ROSC) as fast as possible. Metabolic (lactic)~     acidosis develops rapidly during CA and is considered detrimental to CPR outcome. Sodium~     bicarbonate (SB), a generic, commonly used acid buffer, was subjected only to a single,~     small, prospective controlled trial that found a trend towards improved outcome in prolonged~     OHCA and CPR. Another study indicated that EMS's that used SB early and often during CPR had~     significantly higher ROSC rates and better long-term outcome compared with EMS's that used SB~     more seldom and administered it late in the course of CPR.~      Aim of the Study:~      To determine whether early administration of SB during OHCA and CPR improves short-term CPR~     outcome.~   "
167189|NCT01377324|"~     The dose of fulvestrant to optimally downregulate estrogen receptors (ER) is currently~     subject of debate. Effects of fulvestrant on the ERs may be evaluable by molecular imaging~     using positron emission tomography with the ER-specific FES tracer. In this pilot study we~     will evaluate the effects of the new dose of fulvestrant (500mg i.m.)on the availability of~     ER binding sites in 15 metastatic breast cancer patients.~   "
167190|NCT01377311|"~     Name of the project：The application of cornea stem cells cultured on amniotic membrane in~     patients suffering from corneal stem cell insufficiency~      Purpose: To develop the technique of using ex vivo expansion of autologous limbal stem cell~     cultured on amniotic membrane for treatment of patients suffering from limbal stem cell~     insufficiency~   "
167191|NCT01377298|"~     Because of the advantageous activity against VEGF-C and FGF pathways and favorable toxicity~     profile comparing with sunitinib, the investigators plan this phase II trial of pazopanib in~     cisplatin-refractory recurrent or metastatic HNSCC.~   "
167192|NCT01377285|"~     This is a multicenter, randomized, double-blind, placebo-controlled clinical trial to~     investigate the renoprotective efficacy of combined pentoxifylline (PTX) and angiotensin~     receptor blockers (valsartan), compared with placebo and valsartan in 700 patients with~     Chronic Kidney Disease (CKD) stages 3 and 4. The effect on cardiovascular comorbidity will~     also be observed. The observation period will be 3 years. The primary endpoints consists of~     doubling of serum creatinine, end stage renal disease (ESRD), and death from any cause. The~     secondary endpoints include changes of microalbuminuria or proteinuria, serum and urinary~     levels of TNF-a(tumor necrosis factor-alpha ), MCP-1(monocyte chemotactic protein),~     TGF-beta1(transforming growth factor ), collagens III (amino terminal peptide of procollagen~     III) and IV, and fibronectin, urinary N-acetyl-beta-glucosaminidase, as well as serum~     fibrinogen and high-sensitive CRP(C reactive protein), and development of heart failure,~     nonfatal myocardial infarction, and stroke or transient ischemic attack.~   "
167193|NCT01377272|"~     Data will be extracted from the National Taiwan University Hospital (NTUH) medical records~     database, geocoded according to the street address so that the case number, incidence, etc~     could be mapped. The spatial data would be used to detect the aggregation of HIV cases,~     existence of hot spots and then determine if they may merit further investigation or may~     have occurred by chance. The results from these GIS-based analyses would address local~     variations in HIV prevalence and transmission.~   "
167418|NCT01374282|"~     Cuprimine (penicillamine) was made available in the Philippines by the Sponsor under a~     Compassionate Special Permit issued by the Bureau of Food and Drugs. Physicians were able to~     request the drug for their patients from the Sponsor. A Clinical Study Report form was~     completed for each purchase of Cuprimine.~   "
167194|NCT01377259|"~     Neuraxial anesthesia affords a less interventional way to desensitization of the lower body~     for surgical procedures. After introduction of neuraxial anesthesia, vasodilatation of body~     part below the anesthetic level is theoretically appeared as the sympathetic nerve efferent~     is blocked. The vasodilatation effect is related to hypotension, hypothermia, shivering and~     the response of volume redistribution. It is believed that vasodilatation leads to better~     regional tissue perfusion and better regional tissue oxygenation. Previous reports of laser~     doppler flowmetry and thermography showed their effectiveness on monitoring blocked level but~     they were not easily available in the operation room. Recently Near-infrared~     spectroscopy(NIRS) demonstrates real-time tissue oxygen saturation(rSO2) which is applied~     generally in non-invasive brain oximeter. We use NIRS in spinal anesthesia to monitor the~     tissue oxygenation change over the upper and lower limbs during the induction of neuraxial~     anesthesia.~   "
167195|NCT01377246|"~     The general aim of the trial is to assess the efficacy of one year treatment with long-acting~     somatostatin analogue (Octreotide LAR) compared with placebo in slowing kidney and liver~     growth rate in patients with ADPKD and moderate/severe renal insufficiency and to assess~     whether and to which extent this translates into slower renal function decline over 3-year~     follow-up.~   "
167196|NCT01377233|"~     The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics~     of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.~   "
167197|NCT01377220|"~     Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver.~      Recently, several research studies reported that 11C-choline PET has shown a high detection~     rate of well differentiated HCC, which is an early stage of primary liver cancer. The aim of~     this study was to prospectively evaluate the diagnostic accuracy of 11C-choline PET-CT to~     detect HCC in cirrhotic or non cirrhotic patients.~   "
167198|NCT01377207|"~     Recent studies suggest important gender differences in the pathophysiology and prognosis of~     ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled~     study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus~     formation in patients presenting with STEMI treated with primary angioplasty. Gender-related~     mechanisms of plaque rupture or erosion will be investigated using a combination of~     Quantitative Coronary Angiography, high resolution Optical Coherence Tomography of the~     culprit vessel and histopathologic analyses of thrombus aspirates of the infarct related~     lesion, performed by independent core laboratories, blinded to group (male or female) and~     clinical variables.~   "
167199|NCT01377194|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).~   "
167200|NCT01377181|"~     The role of laparoscopic surgery in pediatric inguinal hernia repair is clear. Laparoscopic~     hernia repair is especially advantageous for bilateral diseases and minimally invasive~     technique in children because it avoids vas injury. However, the problem of recurrent rate~     has not been resolved. The aim of this study was to refine the current criteria used the~     lateral umbilicus ligament covering the internal hernia opening region, and eliminated~     recurrence in laparoscopic inguinal hernia (LIH) repair in children. The investigators~     hypothesized that the lateral umbilicus ligament covering the internal hernia opening region~     after the laparoscopic purse-string knot would result in lower recurrence and the same~     operation relative complication~   "
167201|NCT01377168|"~     This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be~     randomized to receive either oral naltrexone for the treatment of alcohol use disorder or~     placebo. Men with acute, recent or established HIV infection will receive antiretroviral~     treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is~     to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral~     load suppression, among men with alcohol use disorder. The study will also assess the impact~     of oral naltrexone on alcohol use behaviors in this population.~   "
167202|NCT01377155|"~     This study will evaluate two methods of starting basal insulin to see which method may~     achieve a faster-to-goal titration.~   "
167203|NCT01377142|"~     The purpose of this study is to evaluate surgical success or failure one year after surgery~     for pelvic organ prolapse.~   "
167204|NCT01377129|"~     The main objective of this study is to compare, using MRI measures with a specialized splint,~     the persistent rotatory laxity after anterior cruciate ligament reconstruction using single~     bundle and double bundle surgical techniques, between the seventh and eighth months after~     surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).~   "
167205|NCT01377103|"~     The purpose of this study is to evaluate whether benefits of topical testosterone on symptoms~     and function of male HF patients, and its effects on rehospitalization rates and quality of~     life.~   "
167206|NCT01377090|"~     The CAP study is a multicenter, observational, clinical study in patients with systemic~     sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and~     patient-specific disease-related factors in predicting the occurrence of digital ulcers~     within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis~     (limited or diffuse), with or without history of digital ulceration are eligible. The study~     will enroll 500 patients at 70 centers.~   "
167216|NCT01376960|"~     The purpose of this study is to compare, for the first time ever, single shot popliteal fossa~     blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. The~     primary outcome variable for this study is the percentage of patients that convert to general~     anesthesia following either a single shot popliteal fossa block or ankle block.~      H0: There is no difference in the percentage of patients that convert to general anesthesia~     between single shot popliteal fossa blocks and ankle blocks.~      HA: There will be a lower percentage of patients receiving a single shot popliteal fossa~     block that convert to general anesthesia compared to patients receiving an ankle block.~   "
167217|NCT01376947|"~     In this study the investigators compare the difficulty at insertion of IUD between~     nulliparous and parous women. The investigators compare the pain reported by the patient to~     the difficulty reported by the professional that performed the insertion.~      The investigators hypothesis is that there is no difference between nulliparous and~     multiparous patients.~   "
167207|NCT01377077|"~     Rationale: Punch grafting is a safe, simple and widely used technique for in vitiligo.~     However, no reliable data are available on the effect of punch depth and punch size.~      Objectives: Primary: to compare the efficacy and safety of different punchdepths and~     punchsizes in punch grafting in patients with segmental and non-segmental vitiligo.~     Secondary: to assess the practical aspects and patients preference of different punch~     grafting techniques.~      Study design: Prospective observer blinded randomised controlled study. Study population: 35~     patients ≥ 18 years with segmental or stable non-segmental vitiligo who will receive regular~     treatment by punch grafting at the Netherlands Institute for Pigment Disorders (SNIP) at the~     Academic Medical Centre University of Amsterdam.~      Methods: Four depigmented regions on the trunk or upper extremities will be randomly~     allocated to either epidermal 1,5 mm punch grafting, epidermal 1mm punch grafting, dermal 1,5~     mm punch grafting and dermal 1 mm punch grafting. After grafting, all regions will receive~     UV-therapy twice a week for 3 months. Three and six months after grafting, the repigmentation~     of the lesions will be assessed by measuring the outgrowth.~      Main study parameter/endpoint: Outgrowth of pigment after six months.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The study involves 16 additional punch grafts but no additional visits to our~     institute. Patients will not miss any regular treatment. The extra time due to participation~     in the study will be about 40 minutes. No increase of the risk of side effects is expected by~     placing 16 additional punch grafts. 1.~   "
167208|NCT01377064|"~     Because of advances in drug treatment, people living with HIV/AIDS (PLWHA) are living longer,~     but are also at greater risk for cardiovascular disease (CVD) and diabetes. Exercise and~     increased physical activity can reduce the risk factors for these diseases in PLWHA, but no~     studies have tested an at-home exercise program that would benefit low income people and~     others who do not have access to exercise facilities. This study will test the feasibility of~     an at-home exercise program for PLWHA and prepare for a full-scale intervention study, which~     may lead to a reduction in CVD risk among PLWHA.~   "
167209|NCT01377051|"~     The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is~     effective in the acute treatment of COPD and in particular on reducing lung hyperinflation~     and dynamic volumes.~   "
167210|NCT01377038|"~     The primary objective of this study is to evaluate the relative efficacy of a~     centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical~     diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary~     objectives include the determination of which self-report and experimental pain measures best~     differentiate those who respond better to duloxetine than diclofenac.~   "
167211|NCT01377025|"~     Uveal melanoma is the most common primary intra-ocular malignancy in adults with an incidence~     of 0.6 - 0.7 per 100,000 per year.~      Prognosis of metastatic uveal melanoma is poor. In retrospective analyses a median survival~     time after detection of metastases of 5 months (Flaherty et al, 1998) and 7 months (Kath et~     al, 1993) was reported. For patients receiving no treatment reported median survival was 2.0~     months compared with 5.2 months for those receiving treatment for metastases (Gragoudas et~     al, 1991).~      Up to now there is no established treatment of metastatic uveal melanoma. Some therapeutic~     approaches with locoregional treatment or systemic chemotherapy have been undertaken:~      In case of metastatic disease which is confined to the liver in about 85% of patients with~     uveal melanoma surgical resection led to a median survival of 14 months (Mariani et al, 2009)~     or 19 months and a 5-year survival rate of 22% in a selected patient population (Adam et al,~     2006).~      As locoregional treatment option treatment with fotemustine via direct intra-arterial hepatic~     infusion was investigated and led to a median survival of 15 months (Peters et al, 2006).~     This was not a randomized trial, but a report on 101 consecutive treated patients. Additional~     debulking surgery was performed whenever feasible.~      A randomized phase III trial comparing intra-arterial hepatic fotemustine administration with~     intravenous systemic fotemustine and overall survival as primary endpoint is still ongoing~     (EORTC 18021).~      Thus, no systemic chemotherapy is approved for metastatic uveal melanoma. Although no~     specific genes have been linked to the pathogenesis of uveal melanoma, preclinical studies~     suggest potential benefit of inhibitors of Bcl-2, ubiquitin-proteasome, histone deactylase,~     mitogen-activated protein kinase and phosphatidylinositol-3-kinase-AKT pathways, and receptor~     tyrosine kinases.~      Thus, sorafenib as inhibitor of b-Raf and Raf-1 (c-Raf or c-Raf-1), pro-angiogenic vascular~     endothelial growth factor receptor (VEGFR), and platelet-derived growth factor receptor~     (PDGFR) may potentially lead to a benefit for patients with metastatic uveal melanoma in~     terms of disease control and prolongation of survival.~   "
167212|NCT01377012|"~     The core and extension studies assessed the safety and efficacy of secukinumab when added to~     a background therapy in patients with active rheumatoid arthritis who are intolerant to or~     have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab,~     placebo. The core study was completed. However, the extension study was terminated early~     (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy~     of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading~     to closing of the AIN457 RA program.~   "
167213|NCT01376999|"~     The aim of the study is to evaluate if the Step up protocol is equal or superior regarding~     efficacy and security than the step down protocol. In couple submitted two intrauterine~     insemination.~   "
167214|NCT01376986|"~     The aim of the study is to investigate different novel IC technologies for promoting physical~     activity and health and preventing obesity in young men. The purpose is to provide new~     evidence-based knowledge on the effectiveness of an ICT-based physical activation and to~     identify factors predicting a positive response.~      Specific objectives~        -  to identify the factors associated with physical activity and physical activity~          relationship in young men~        -  to develop an interactive method, based on peer networks, aimed at activating young men~          with use of their own skills, participation and modern ICT~        -  to assess the effectiveness of the chosen activation on the physical activity, weight,~          fitness, health, and relationship towards physical activity among young men~      The study population consists of all conscription aged men in the Oulu area in 2011-2013~     (n=4000). Conscription-aged men provide a large, population based representative sample of~     young men. In Finland military service is mandatory and annually all 18-year old men are~     called for military service. In the call-ups fitness for service is determined based on~     medical examination.~      All those who are determined fit for service or who are granted postponement due to obesity~     will be invited for the activation intervention study. Those with severe obesity are exempted~     from service, but will also participate in the trial. After the call-up, the men will be~     randomised to an intervention group and a control group. The primary outcome variable is~     change in physical activity.~      The study will be conducted during 2011-2015. The study includes technology development (ICT~     platform), collection of cross-sectional data at the call-ups, and a 6-month physical~     activity intervention (a randomized controlled trial) implemented between the call-up and~     start of military service. Game mechanics are integrated into the ICT platform to increase~     user engagement and participation.~      Physical activity, fitness (aerobic and muscular), body composition,lifestyle and~     psychological and physical health will be followed. In addition, the subjects' entry into~     military service and its course will be followed.~   "
167215|NCT01376973|"~     Stress is an important cause factor of temporomandibular disorder (TMD) and Police Officers~     are exposed to stress. Aim of the study was to evaluate clinical and electromyographically~     the effect of two different occlusal splints on police officers with TMD~   "
167419|NCT01374269|"~     Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and~     improving function and quality of life during a 6-months follow-up of a therapeutic exercise~     program compared to pharmacological treatment with NSAIDs in patients with subacute low back~     pain attending the physiatrist consultation of several ambulatory health centers in Medellín~     during the years 2009-2010.~   "
167221|NCT01376895|"~     The goal of this study is to develop and test a program to help Black men who have sex with~     men and women reduce their chances of getting or giving HIV infection to their sex partners.~     The program is designed to be delivered via the internet so that it would be available to~     more men. Men who agree to participate in the study will be assigned by chance to receive the~     POWER intervention or a similar program that is focused on general health called~     POWER-HEALTH. They will also complete a computer administered interview when they first~     enroll in the study, 2 weeks following the last session of the program and 3 months after~     that. Participants will receive a small compensation for their time and effort.~   "
167222|NCT01376882|"~     The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as~     compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood~     flow effects will also be assessed in a subset of participants. The role of caffeine~     abstinence/maintenance in the acute effects of caffeine will also be explored.~   "
167223|NCT01376869|"~     Hops have been used for many years for their supposed sedative and anxiety reducing~     properties and can be found in many natural remedies for stress, anxiety and sleeping that~     are already available to buy.~      However, human trials investigating the effects of hops have so far been limited to the~     effects of the combination of hops and valerian in relation to sleep. Such studies have~     identified that a valerian-hops mixture can result in improved sleep but Valerian alone has~     no effect.~      The current study aims to investigate the effect of hops alone in healthy human participants~     aged 18-35 years.~   "
167224|NCT01376856|"~     The purpose of this study is to analyze pathologic and radiologic characteristics of~     mediastinal lymph nodes with false positive FDG PET/CT results in lung cancer staging and~     assess relationship between false positive mediastinal lymph node and TB/latent TB.~   "
167225|NCT01376843|"~     The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and~     Quantiferon-TB Gold In tube assay in health care workers.~   "
167226|NCT01376830|"~     Respiratory virus infections are a common cause of COPD exacerbations and antiviral therapies~     have potential as treatments for exacerbations. However it is likely that treating patients~     when they present with an exacerbation with antiviral drugs will be too late to be effective~     and earlier treatment at the time of the initial upper respiratory tract infection (URTI)~     will be required. The incidence of exacerbations following URTIs in COPD patients, and~     whether there are host factors and biomarkers that can identify the risk of this, is unknown.~     The aims of this study are to establish the proportion of viral URTIs that progress to an~     acute exacerbation in COPD patients and identify clinical, viral and biological markers that~     predict risk of an exacerbation following an URTI. In addition we will determine the~     frequency of, and risk factors for, bacterial infection following viral URTIs in COPD~     patients. This data will permit development of a model combining baseline patient~     characteristics, clinical measurements and biomarkers to predict exacerbation risk following~     viral URTI in COPD patients. The results will open the way for trials of antiviral therapy in~     COPD exacerbations and targeting of treatment to high risk patients.~   "
167227|NCT01376817|"~     The purpose of this study is to comparatively assess the potential antiinflammatory effects~     of intravenous lipid emulsions rich in omega 3 polyunsaturated fatty acids and olive oil~     versus intravenous lipid emulsions made exclusively with MCT and LCT on the evolution of~     patients with severe acute pancreatitis during the period in needing artificial nutrition~     support with total parenteral nutrition so unique.~   "
167228|NCT01376804|"~     This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte~     (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant~     recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte~     orally daily for up to 200 days post-transplant and will be followed for 52 weeks~     post-transplantation.~   "
167229|NCT01376791|"~     We propose to examine a population of Native Americans who have had little or no dental care,~     and to determine if periodontal disease is associated with early signs of vascular~     dysfunction or systemic inflammation. We then propose to treat the periodontitis and~     re-evaluate vascular function. We will determine if gingivitis or mild/moderate periodontitis~     is associated with detectable vascular dysfunction. Microbial metagenomics will be correlated~     with vascular function.~   "
167230|NCT01376778|"~     Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects.~     When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue,~     weakness, fever, swollen glands). Most people in the United States are infected during~     childhood or as adults if they work around children. Pregnant women, who have not been~     infected with CMV in the past and become infected during pregnancy (i.e. a primary~     infection), may cause their babies to get infected with CMV. Babies that are infected may~     develop permanent disabilities including hearing loss and a small portion will die from the~     infection.~      Currently it is not routine practice to screen pregnant women for CMV infection.~     Additionally, there is no agreement about how to evaluate and manage pregnant women infected~     with CMV for the first time. There is also no evidence that treatment is beneficial for the~     baby.~      The purpose of this research study is to determine whether treating pregnant women who have a~     primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.~   "
167231|NCT01376765|"~     This is a multi-center, randomized, double-blinded, placebo-controlled, outpatient study.~     Recombinant deltaTM S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine With and~     Without Aluminum Hydroxide Adjuvant (Provided through contract N01-AI-30023, manufactured by~     Protein Sciences Corporation), two doses, administered at 28 day interval. 1. S Protein~     Severe Acute Respiratory Syndrome (SARS) Vaccine without adjuvant: 5.0, 15.0 and 45.0 mcg per~     0.5 ml dose. 2. S Protein SARS Adjuvanted Vaccine: 5.0, 15.0 and 45.0 mcg per 0.5 ml dose.~     PLACEBO: diluents/placebo without vaccine (Phosphate Buffer Saline (PBS) with lower phosphate~     concentration). Approximately 84 healthy male and nonpregnant female subjects 18 to 40 years~     of age will be enrolled.~   "
167232|NCT01376752|"~     CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial~     ovarian cancer is able to improve the median OS by 12 months. In that hypothesis, with alpha~     risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years~     follow-up, the number of patients to include is 404. Taking into account a 10% failure, an~     overall number of 444 patients is required.~   "
167233|NCT01376739|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Magnevist at a dose of more~     than 0.2 ml/kg for MR angiography of peripheral vasculature with continuous imaging from the~     abdomen to the lower extremities. The objective of this study is to assess safety, especially~     in relation to renal dysfunction, and efficacy of using Magnevist in clinical practice. A~     total 2,000 patients will be recruited.~   "
167234|NCT01376726|"~     The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in~     healthy, HIV-uninfected adults who have participated in a previous HIV vaccine clinical trial~     and in healthy, HIV-uninfected adults who have not participated in a previous HIV vaccine~     clinical trial.~   "
167235|NCT01376713|"~     The purpose of this study is to assess the overall disease control rate of Ofatumumab wo/w~     Dacarbazine in subjects with American Joint Committee on Cancer (AJCC 2009) unresectable~     stage III or stage IV melanoma.~   "
167236|NCT01376700|"~     The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg~     ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype~     (ie, joint bleeding), together with the minimization of immunological danger signals, can~     reduce the incidence rate of inhibitor formation in PUPs with severe and moderately severe~     hemophilia A.~   "
167237|NCT01376687|"~     Back pain affects the majority of the population at some time. Currently there are no~     published and scientifically accepted objective measures to support manual medicine~     diagnostic and treatment techniques for back pain. The purpose of this project is to collect~     and evaluate objective (pressure and motion) data from standard clinical diagnostic tests.~   "
167238|NCT01376674|"~     Immunological effects of radiotherapy have been described before, but not evaluated in a~     time-dependant manner.~      In order to identify a possible time frame for combination therapies, white blood cells are~     isolated of samples taken at different time points before during and after standard~     radiotherapy in patients with localised prostate cancer. The overall activity of the~     T-cell-system as well as tumor-specific T-cell-response are evaluated.~   "
167239|NCT01376661|"~     The purpose of this research study is to monitor the feasibility and outcome of the Active~     Surveillance Program for men with low risk prostate cancer.~   "
167240|NCT01376648|"~     Brown adipose tissue (BAT) is important in energy expenditure through thermogenesis although~     the regulatory factors are not well known in humans. There is evidence suggesting that the~     thyroid hormones affect BAT functions in lower mammals, but the effects of the thyroid~     hormones on BAT activity in humans are still unclear. The objective of this study was to~     investigate the effects of thyroid hormones on glucose metabolism of BAT and other organs in~     humans.~   "
167241|NCT01376635|"~     Background/Aims: To evaluate the sympathovagal balance in patients with chronic kidney~     disease (CKD) on conservative treatment. Methods: In a cross-sectional study, patients with~     CKD stages 3, 4 and 5 not yet on dialysis (CKD group) and age-matched healthy subjects (CON~     group) underwent continuous heart rate recording during two twenty-minute periods in the~     supine position (pre-inclined), followed by passive postural inclination at 70° (inclined~     period). Power spectral analysis of the heart rate variability was used to assess the~     normalized low frequency (LFnu), indicative of sympathetic activity, and the normalized high~     frequency (HFnu), indicative of parasympathetic activity. The LFnu/HFnu ratio represented~     sympathovagal balance.~   "
167242|NCT01376622|"~     Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands,~     particularly the pituitary gland, remains common in patients with transfusion dependent~     anemias. We would like to establish accurate population norms of pituitary R2 and volume and~     understand the progression of pituitary iron in transfused patients on Deferasirox.~   "
167243|NCT01376609|"~     Previous research has shown there wasn't inevitable relationship between mismatch area and~     infarct growth according to Volumetric-subtraction mismatch volume.The recently published on~     Stroke paper has proposed Coregistration mismatch to calculate the mismatch to replace~     ischaemic penumbra, and it reignites hope for clinical application of the PWI/DWI mismatch.~     But the correlation between the mismatch, calculated by Coregistration mismatch method,and~     the clinical outcome of the patients with acute ischemic stroke is still unknown. so the~     investigators plan to conduct a prospective observational cohort study.~   "
167244|NCT01376596|"~     This study will explore the helpfulness of a short psychological group treatment called~     cognitive-behavioral therapy, or CBT. CBT is a form of therapy that is very structured and it~     aims to improve difficulties that are related to behaviors and emotions by first working on~     identifying and changing negative inaccurate thoughts. The main goal of this intervention is~     to see if group CBT reduces the symptoms of social anxiety in people with schizophrenia so~     that they can improve their social functioning and help their psychotic symptoms. The study~     compares the usefulness of adding CBT to standard services.~   "
167245|NCT01376583|"~     The study investigates the explanation for the positive relation found between exercise and~     breastcancer.~   "
167246|NCT01376570|"~     This study will test whether contingency management (monetary vouchers contingent on~     abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads~     to improved outcomes in other related behaviors (achieving HIV viral load suppression). In a~     randomized controlled trial, the investigators propose to test whether an~     abstinence-reinforcing contingency management intervention improves viral load suppression in~     HIV-infected drug users.~   "
167247|NCT01376557|"~     This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in~     combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate~     glycemic control on metformin monotherapy.~   "
167248|NCT01376544|"~     During assist control ventilation and pressure support ventilation (PSV), the start of~     ventilator inflation is determined by the start of the infant's inspiratory effort. During~     PSV, termination of inflation is determined by the level of the infant's inspiratory flow. In~     a randomized trial, no significant differences were found between assist control and pressure~     support ventilation with regard to the duration of weaning, time to successful extubation,~     work of breathing, rate of asynchrony and level of respiratory muscle strength.~   "
167249|NCT01376531|"~     The aim of the study is to characterize the influence of continuous veno-venous hemodialysis~     on the cerebrovascular autoregulation.~   "
167252|NCT01376492|"~     The purpose of this study is to establish the relationship between performance of patients~     with schizophrenia and relationship with perceived quality of sleep. The secondary objectives~     are: to establish the prevalence of schizophrenic patients reporting sleep disturbances; to~     assess the potential epidemiological risk factors associated with the perceived impairment of~     quality of sleep; to establish the relationship between the clinical condition and the~     quality of sleep perceived; to assess the performance level of patients.~   "
167253|NCT01376479|"~     The purpose of this study is to evaluate the safety and immune response of an inactivated~     vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).~   "
167254|NCT01376466|"~     The purpose of this study is to determine whether computed tomography is reliable~     investigation in the diagnosis of acute appendicitis.~   "
167255|NCT01376453|"~     The main purpose of this study is to find the maximum tolerable dose of sorafenib when~     administered along with another drug called 5-Fluorouracil (5-FU) and to find out more about~     whether these drugs, along with radiation, can help people with rectal cancer when given~     before surgery. 5-FU and radiation are both approved by the US Food and Drug Administration~     (FDA) for use in people with rectal cancer.~      The investigators will utilize a standard 3 + 3 phase I study design. In the phase I part of~     the study, the investigators will attempt dose escalation of sorafenib in combination with~     standard infusional 5-FU and external beam at standard doses. Clinical staging should be done~     by endorectal ultrasound (ERUS) and/or pelvic magnetic resonance imaging (MRI) for T and N~     stage; chest and abdomen computed tomography (CT) for staging of metastatic disease; undergo~     sigmoidoscopy and/or colonoscopy done by crude odds ratios (CORS); biopsy is taken for~     diagnosis and extra is sent for tissue bank. At the maximum tolerated dose (MTD) of sorafenib~     we will expand the cohort to 6 more patients to further evaluate toxicity profile and~     efficacy.~   "
167256|NCT01376440|"~     The Millenium development goals (MDGs) call for reducing by half the proportion of people~     without sustainable access to safe drinking water. This goal was adopted in large part~     because safe drinking water has been seen as critical to fighting diarrheal disease. Source~     protection is considered the main intervention area to achieve this goal. However, research~     worldwide that has shown that even drinking water which is safe at the source is subject to~     frequent and extensive fecal contamination during collection, storage and use in the home.~     This contamination is through the introduction of cups, dippers or hands, contamination by~     flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can~     pose infectious disease risks if they become contaminated due to unsanitary collection,~     storage conditions and practices within households.~      To reduce this problem, point-of-use water treatment has been advocated as a means to~     substantially decrease the global burden of diarrhea and to contribute to the MDGs. However,~     research indicates that there are many unanswered questions around Household water treatment~     (HWT) that require small or medium scale epidemiological studies and randomized controlled~     trials, especially with regard to effectiveness, acceptability and identifying suitable~     target populations. Some of the most urgent questions to be resolved are:(1) How much of the~     currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on~     nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted?~     (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease~     is high.~      hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive~     children? hypothesis: Do household water treatment with chlorine acceptable in the community?~   "
167257|NCT01376427|"~     This study proposes to provide adequate treatment and is based on current scientific evidence~     for elderly patients with ALL Bcr / Abl positive.~      To determine whether low-dose chemotherapy associated with imatinib or dasatinib has~     acceptable tolerability in elderly patients.~      To determine whether this association can increase the rate and quality of referrals to the~     results of the literature of imatinib as monotherapy for elderly patients~   "
167258|NCT01376414|"~     This pilot study aims to estimate the prevalence of Helicobacter pylori (H. pylori)~     colonization in patients presenting with non-specific abdominal pain (NSAP) in an urban~     academic emergency department (ED) located in Washington, DC.~   "
167259|NCT01376401|"~     This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy~     (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone~     (BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease progression or~     unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible for autologous~     transplant receive four cycles of BVP, hematopoietic stem cell collection and administration~     of two cycles BVP over followed by autologous transplant.~      In addition to the overall response rates, will also be analyzed time to progression (TTP),~     progression-free survival (PFS) and overall survival.~      Finally, the results will be compared with BVP with those obtained in 120 patients included~     in our protocol VMP GEM10MAS65.~      Patients will be evaluated at scheduled visits up to 3 periods of study:~      pretreatment, treatment and monitoring.~   "
167260|NCT01376388|"~     The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444~     Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry~     Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary~     Disease (COPD). This is a multi-centre, open-label study evaluating the safety of~     GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the~     morning. The target enrolment is approximately 120 subjects at approximately 20 study centres~     in Japan. The total duration of subject participation will be 54-55 weeks, consisting of a~     7-14 day run-in period, 52-week treatment period and 1-week follow-up period. Subjects~     meeting all of the inclusion criteria and none of the exclusion criteria at screening visit~     (Visit 1) will enter 7-14 day run-in period. The run-in period is provided for completion of~     baseline safety evaluations and to obtain baseline measures of COPD status. At Visit 2,~     eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and enter the treatment~     period. This treatment will be delivered via the Novel Dry Powder Inhaler (nDPI) once daily~     in the morning for 52 weeks. One nDPI will contain 30 doses of study medication. Subjects~     will be instructed to administer medication once daily in the morning for the duration of the~     52-week treatment period. Each subject should be advised to adhere to this dosing regimen~     throughout the study. There will be a total of 8 study visits including at screening (Visit~     1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks,~     52 weeks (Visit 3 through Visit 8, respectively). Follow-up (Visit 9) will be conducted by~     the phone contact approximately 1 week following the completion/withdrawal of treatment~     period. A subject will be considered to have completed the study upon completion of the last~     on-treatment visit (Visit 8). At the end of the treatment period, subjects will be prescribed~     appropriate COPD medication at the investigator's discretion.~   "
167305|NCT01375803|"~     This study will critically evaluate the effects of a novel dietary fiber administered to~     subjects at high risk for developing diabetes to determine if this intervention will improve~     insulin sensitivity compared to control product administration and, thus, decrease risk for~     developing diabetes.~      The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly~     decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic~     subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening)~     compared to consumption of the control product.~   "
167306|NCT01375790|"~     This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator.~      The principal hypothesis is that whole-body vibration training plus exercise improves the~     body balance and prevents falls more than only exercise training in institutionalized older~     people. The number needed of patients is 160 (80 per group).~   "
167261|NCT01376375|"~     Background:~      - Acupuncture is a traditional Chinese medical treatment. Thin needles are used to stimulate~     specific points in the body. Previous studies have found that acupuncture can be useful in~     treating low back pain. This study will explore how acupuncture affects low back pain.~     Researchers will look at blood samples for changes in different chemicals related to~     inflammation and pain.~      Objectives:~      - To test the effect of acupuncture on blood chemicals associated with chronic low back pain.~      Eligibility:~        -  People at least 18 years of age who have chronic low back pain.~        -  Those who have had back surgery or had acupuncture for any medical condition may not~          participate.~      Design:~        -  This study requires eight visits over 2 to 3 weeks. Each visit will take 1.5 to 2 hours.~        -  At the first study visit, participants will give a medical history and complete two~          questionnaires about their low back pain. They will also spend 30 minutes lying down on~          a bed, relaxing quietly.~        -  The next visits will occur every 2 to 3 days for the next 2 weeks. Participants will~          receive 30 minutes of either sham or standard acupuncture. Sham acupuncture will mimic~          the standard procedure, but no needles will be used. The standard procedure will be~          performed in the same location. A licensed, experienced acupuncturist will insert small~          disposable needles into acupuncture sites on the back, arms, and legs. Those in the~          study will not know whether they are receiving the sham or the standard acupuncture~          procedure.~        -  At some visits, participants will provide blood samples for testing. At every visit,~          participants will complete the questionnaires about low back pain.~   "
167262|NCT01376362|"~     The objective of this study is to investigate the safety and efficacy of ocular instillations~     of interferon gamma-1b as a potential treatment for cystoid macular edema (CME) secondary to~     uveitis.~   "
167263|NCT01376349|"~     RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer~     survivors.~      PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to~     placebo in treating postmenopausal cancer survivors with vaginal symptoms.~   "
167264|NCT01376336|"~     Environmental health-related pathogens include faecal-oral, diarrhoeagenic microbes that may~     be transmitted via drinking water and are related to sanitation and hygiene. Previous~     research has suggested that safeguarding household drinking water against recontamination may~     be a critical intervention that can reduce risks of diarrheal diseases and may be especially~     important for people living with HIV/AIDS (PLWHA) and other vulnerable populations (Clasen et~     al. 2007). The investigators propose here a randomised, controlled trial of a household safe~     storage container for drinking water in a well defined, HIV-impacted population in peri-urban~     Lusaka, Zambia. After a baseline data collection period (9 months) half of all households~     (150 households) will be given a safe water storage container specifically designed to~     prevent recontamination of water in household use. All households will be followed for an~     additional 9 months. Results of this study will help determine whether this promising water~     quality intervention can reduce diarrhoea and related outcomes in this and similar vulnerable~     populations.~   "
167265|NCT01376323|"~     The aim of this combined, two part study is to evaluate the safety and glucose lowering~     effects of GSK256073 when administered to diabetic subjects for 12 weeks.~   "
167266|NCT01376310|"~     This is an open-label study which will permit subjects with solid tumors or leukemia, who are~     currently clinically benefitting on another GSK sponsored trial with GSK1120212 either~     monotherapy or in combination continued access to GSK1120212.~   "
167267|NCT01376297|"~     NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two~     antiemetic drugs, both given with oral dexamethasone. The objective of the study is to~     evaluate if netupitant and palonosetron are safe when administered to prevent nausea and~     vomiting after administration of repeated cycles of chemotherapy.~   "
167268|NCT01376284|"~     The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg~     collected from the required number of Japanese subjects with benign prostatic hyperplasia~     (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its~     use at post-marketing clinical settings.~   "
167269|NCT01376271|"~     The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use~     in Japanese Social Anxiety Disorder (SAD) subjects.~   "
167270|NCT01376258|"~     Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be~     associated with improved clinical outcomes for patients with enlarged prostates (EP) and~     lower health care related costs.~      The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and~     length of therapy and the likelihood of acute urinary retention (AUR), prostate-related~     surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or~     prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and~     Medicare population. The null hypothesis is that no differences will be observed in the~     outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not. The~     test hypothesis is that patients with higher levels of adherence to 5ARI for a longer period~     of time will experience significantly fewer adverse outcomes and significantly lower~     treatment costs.~      The data source for this analysis is the MarketScan database, which contains medical and~     pharmacy claims for commercial health plan members and Medicare recipients. Medical and~     pharmacy claims data are sourced directly from health plans and employers. The database~     represents approximately 18 to 20 million individuals annually and nearly 22 million Medicaid~     enrollees from multiple states. The database includes the Medicare-covered portion of~     payment, the employer-paid portion, and any out-of-pocket expenses paid by the beneficiary.~      The study design is a retrospective cohort analysis. Each patient's index date was defined as~     the date of the first fill for a 5ARI prescription.~   "
167271|NCT01376245|"~     The purpose of the study is to investigate the efficacy and safety of fluticasone~     furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period~     in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).~   "
167272|NCT01376232|"~     Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an~     Inhibitor of CYP2C8 (gemfibrozil),]~   "
167307|NCT01375777|"~     The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG~     145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change~     from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.~   "
167273|NCT01376219|"~     The economic cost of asthma is considerable both in terms of direct medical costs (such as~     the cost of pharmaceuticals and hospital admissions) and indirect medical costs (such as time~     lost from work and premature death).~      The costs of asthma depend on the severity of disease and the extent to which exacerbations~     are avoided. Moreover, poor control of asthma symptoms is a major issue that can result in~     adverse clinical and economic outcomes.~      According to GINA guidelines, the goal of asthma treatment is to achieve and maintain asthma~     control. Such an objective can be reached in a majority of patients with a pharmacologic~     intervention strategy developed in partnership between the patient/family and the doctor.~     Validated measures for assessing asthma control score goals as continuous variables and~     provide numerical values to distinguish different levels of control. Among them, the Asthma~     Control Test (TM - QualityMetric Incorporated) is widely recognized. Few data exist on the~     relationship between asthma control and health care consumption.~      Some models for predicting asthma costs have been proposed. However, these models only~     attempt to assess costs associated with medications and/or asthma exacerbations. Furthermore,~     in such studies, asthma control was not defined accordingly to current international~     criteria.~      Considering the increasing interest of health authorities in reducing asthma associated costs~     and improving quality of care, it appears necessary to study the relationship between the~     cost and the level of control.~   "
167274|NCT01376206|"~     To investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray~     in Japanese subjects with allergic rhinitis under the practical use conditions~   "
167275|NCT01376193|"~     The study is designed to investigate the information on safety and efficacy of naratriptan~     tablets on Japanese subjects with migraine headache during Japanese post-marketing~     surveillance period.~   "
167276|NCT01376180|"~     The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to~     collect information for using lamotrigine tablet effectively and safely as well as to grasp~     onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women,~     subjects with poor renal and hepatic functions.~   "
167277|NCT01376167|"~     The purpose of this two part study is to test the safety and efficacy of Tafenoquine (with~     Cholorquine) as a radical cure for Plasmodium vivax (P.vivax) malaria relative to the control~     Chloroquine.Part 1 aims to select an efficacious and well tolerated dose that can be~     co-administered with Chloroquine. Part 2 will investigate the safety and efficacy of the~     selected dose (300 mg tafenoquine) in the treatment and radical cure of Plasmodium Vivax~     Malaria.~   "
167278|NCT01376154|"~     The purpose of this study is to confirm efficacy and safety when administering lamivudine~     tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.~   "
167279|NCT01376141|"~     The study is designed to detect adverse drug reactions (particularly clinically significant~     adverse drug reactions) occurring in clinical settings, to examine factors likely to affect~     the safety and efficacy of sumatriptan tablet, and to discuss the need of special~     investigation and postmarketing clinical study.~      A special focus was placed on the investigation of occurrence of ischaemic heart~     disease-like events including arrhythmia, angina pectoris, and myocardial infarction in the~     present study.~   "
167280|NCT01376128|"~     The objectives of this survey was to retrospectively collect and evaluate the information on~     the efficacy and safety of PAXIL tablets (PAXIL, hereinafter) in pediatric subjects (aged~     under 18) with panic disorder under conditions of actual use.~   "
167281|NCT01376115|"~     To investigate safety and efficacy on Japanese subjects treated with nelarabine injection for~     intravenous use in clinical settings of the following diseases:~        1. T-cell acute lymphocytic leukemia (T-ALL)~        2. T-cell lymphoblastic lymphoma (T-LBL) Also, any adverse events involving neurological~          disorder, hypotension, and blood disorder and their details are to be investigated as~          an item of particular concern. In addition, subject outcome (alive or dead) at one year~          after the start of treatment will also be investigated.~   "
167282|NCT01376102|"~     This is an open label, multi-centre, non-interventional post-marketing surveillance~   "
167283|NCT01376089|"~     The purpose of this study is to evaluate and compare overall patient comfort profile between~     the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast~     media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed~     Tomographic (CECT) imaging of the abdomen/pelvis.~   "
167284|NCT01376076|"~     This study will evaluate the effects of sequential multiple dose regimens of cariprazine on~     cardiac repolarization in patients with schizophrenia.~   "
167285|NCT01376063|"~     The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the~     plasma pharmacokinetic of rosiglitazone in healthy adult subjects.~   "
167286|NCT01376050|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     as an adjunctive therapy to the healing of venous stasis leg ulcers.~   "
167287|NCT01376037|"~     The purpose of this study is to determine if the Erchonia® ML Scanner (MLS) low level light~     laser device can help to reduce the circumference of the upper arms.~   "
167308|NCT01375764|"~     The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG~     145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein~     cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective~     dose of a statin.~   "
167309|NCT01375751|"~     The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous~     evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in~     adults with heterozygous familial hypercholesterolemia (HeFH).~   "
167310|NCT01375738|"~     This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in~     patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood~     glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to~     evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in~     gastric cancer patients with diabetes.~   "
167311|NCT01375725|"~     The purpose of this study is to measure prothrombin time (PT) expressed in International~     Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an~     experimental device and a commercially available device. This study will involve taking a~     finger-puncture and testing onto a strip and meter system for the experimental and~     commercially available devices.~   "
167288|NCT01376024|"~     The study hypothesizes that there exist effective non-operative and operative treatments for~     certain patient populations with basal joint arthritis of the thumb. There also exists a~     functionally superior, cost effective, and low risk non-operative or minimally invasive~     operative treatment regime to alleviate pain and slow the progression of disease in those~     with less advanced disease. Likewise, there is significant functional, health utility, and~     economic advantage to surgically treating advanced basal joint arthritis with one of the~     popularized procedures currently in practice.~      Arthritis at the base of the thumb is a common condition associated with considerable patient~     discomfort. Many non-operative and operative treatments have been described, but few~     prospective studies involving multiple centers comparing these treatments have been done. By~     following patients from the start of their arthritis treatment and assessing their progress~     at certain time points using questionnaires and radiographs the investigators believe patient~     outcomes and satisfaction can improve. This study will include patients who are treated~     non-operatively and operatively and will not change patients' standard of care. By~     establishing standardized outcome measures and collecting data prospectively from the time of~     initial presentation through all treatment interventions it will be possible to directly~     compare treatments during the conservative and operative care of basal joint arthritis of the~     thumb. This multi-center study will identify those specific procedures or conservative~     treatments that have the greatest potential to be studied in subsequent focused and~     well-designed randomized control trials.~   "
167289|NCT01376011|"~     The purpose of this study is to find out if quercetin can increase blood levels of~     hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a~     corresponding increase in blood flow to the brain.~   "
167290|NCT01375998|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received YAZ for dysmenorrhea. The~     objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A~     total 3,000 patients will be recruited and followed 3 years since starting YAZ~     administration.~   "
167291|NCT01375985|"~     The purpose of this study is to characterize the safety and pharmacology of single~     administrations of AVI-7100, a candidate treatment for influenza.~   "
167292|NCT01375972|"~     To select a better agent between S-1 or gemcitabine in combination with cisplatin for the~     conventional chemotherapy platform for future development in advanced Biliary Tract~     Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and~     cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.~   "
167293|NCT01375959|"~     Resveratrol is a substance found in many plants, including grapes and red wine, which is~     widely used as a nutritional supplement. Studies in cells and lower animals show that~     resveratrol has many potential benefits, including prolonging lifespan, preventing cancer and~     heart disease and normalization of glucose metabolism. Although use of this agent shows great~     promise in the treatment and/or prevention of diabetes, there have been no studies reported~     to date in humans. As an initial step, this proposal is for a 6 week pilot study of~     resveratrol treatment in older adults with impaired glucose tolerance (IGT) in order to~     explore its effects on post-meal blood glucose metabolism. Preliminary studies will also be~     conducted to explore how resveratrol works by studying cellular function (in muscle samples~     obtained from study participants) and by testing resveratrol's effect on blood vessel~     function.~   "
167294|NCT01375946|"~     A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal~     delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and~     external conditions of heat, humidity, cold water and exercise.~   "
167295|NCT01375933|"~     The purpose of this study is to assess the comparability of the phase 3 lot and a single~     commercial lot of NicVAX in healthy smokers.~   "
167296|NCT01375920|"~     Depression is one of the most common mental health problems, with at least one in six adults~     suffering from this at some time in their life. It can become long-lasting and frequently~     recurs. Depression has a large negative impact on quality of life of patients and their~     carers and it has also been shown to be one of the leading causes of working age adults~     receiving disability payments in the UK. The need for improved treatment has been recognised~     by the Department of Health and others. Improvements in drug treatments are therefore~     required. There has been recent increased understanding of some of the causes of the frequent~     lack of complete response seen with antidepressants. The stress hormone, cortisol, is often~     elevated or poorly controlled in depression and there is laboratory and clinical research to~     show that this hormonal change reduces the benefits from antidepressants with associated poor~     outcome and memory problems. Recently it has been shown in small studies that giving~     treatments that reduce cortisol or block its harmful effects for between 1 and 3 weeks~     overcome these negative consequences. Our group is particularly interested and experienced in~     this topic. The investigators plan to study a drug that decreases cortisol levels in people~     who have not recovered with standard antidepressants so that the investigators can find out~     the usefulness of this treatment (compared with placebo (dummy tablet)) in day to day life as~     well as checking closely for side-effects (the initial studies have shown that the particular~     drug the investigators wish to study (metyrapone) has few side effects). The investigators~     will also measure cortisol and see if its level can tell us which people do best with this~     treatment. The investigators will carry out this study in 3 centres across the UK. The~     investigators will carry out some additional tests of specific sorts of memory and decision~     making and also do this while scanning the brain (in a painless test). The results of these~     tests, along with tests of brain wave patterns, should help us understand more fully how this~     new treatment is working and who responds best to it. The study will help us find out if this~     drug should be used more widely for people not responding to standard treatments and will~     also lead on to the development of other new treatments with an anti-cortisol effect to help~     tackle the major problem of poor outcome from depression.~   "
167297|NCT01375907|"~     The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for~     Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.~   "
167312|NCT01375712|"~     The objective of this study is to evaluate if consumption of fermented milk containing~     Lactobacillus casei strain Shirota has an impact on stool consistency, stool frequency,~     constipation-related symptoms, and quality of life in subjects who frequently have hard or~     lumpy stools.~   "
167313|NCT01375699|"~     Sildenafil increases the therapeutic effect of doxorubicin used as treatment for cancers of~     solid tumors through both an increase in anti-tumor effects and protection from cardiac~     toxicity.~   "
167377|NCT01374828|"~     Pain control following surgery is a critical aspect of patient care. Pain at incision sites~     in laparoscopic surgery contributes to overall pain felt by a patient. There is no definitive~     proof that the typical medications (such as lidocaine) injected at incision sites during~     surgery improve pain control. This study looks at a different type of medication (ketorolac -~     an NSAID) to better control pain at laparoscopic incision sites.~   "
167298|NCT01375894|"~     The ability to understand the other's perspective and respond accordingly is the most~     important normal process of daily social life and is probably one of the foundations of human~     existence. This capability is reflected, inter alia, as an imitation - an important and~     effective form of learning which is very developed in humans. When we are required to imitate~     a particular movement, speed of response depends on the perspective of the movement.~     Imitative response is implemented faster when the movement is observed from first-person~     perspective, than if the motion is presented from the perspective of a third party.~      While healthy individuals don't find it difficult to imitate, or to understand the other's~     emotion expression, there are psychiatric populations (such as autism and schizophrenia) who~     find it difficult to demonstrate these capabilities (Park, Matthews et al. 2008). Beyond~     these capabilities impairment, schizophrenic patients have difficulty distinguishing between~     their arm movements and those of a foreign hand and find it difficult to leave the boundaries~     of egocentric interpretation of reality and adopt the other's point of view. These behavioral~     disorders arise from defects in the network of mirror neurons (Buccino and Amore 2008;~     Langdon, Coltheart et al. 2010).~      Therefore, the investigator expect that schizophrenic patients will not see a preference for~     movements that will be displayed in first-person perspective from the same movements that~     will be displayed from the perspective of a third party. Consequently, the investigator~     speculate that these subjects will not exhibit differences at imitating the response of which~     will be presented from different perspectives (Jackson, Meltzoff et (al. 2006.~   "
167299|NCT01375881|"~     The purpose of this non-interventional study is a description of use of darunavir in daily~     practice, in retrospective and perspective manner. Darunavir will be prescribed in the usual~     manner and in accordance with the terms of marketing authorization. The assignment of a~     patient to a particular therapeutic strategy will not be decided in advance by this study~     protocol but instead, it will be part of the current clinical practice. The prescription of~     the medicinal product will be clearly separated from the decision to include the patient in~     the study. No additional diagnostic or monitoring procedures will be applied to the patients,~     and epidemiological methods will be used for the analysis of collected data. After having~     agreed with the patient on starting treatment with darunavir, and provided that all inclusion~     and exclusion criteria apply, the physician will document the patient's data. Patients will~     be observed for at least 48 weeks from baseline visit except for those who withdraw from the~     study earlier. Patients data will be collected at approximately 0, 1, 3 and 6 months after~     starting treatment and subsequently every 3 months in accordance with routine practice. The~     expected number of patients to enroll is about 900. The patients will be treated with~     darunavir according to the Italian label. The patient must be withdrawn from the study if the~     treatment with darunavir has been stopped. A last evaluation must be documented when~     possible, and a resistance test will be collected if available for patients discontinuing for~     virologic failure. At the end of study visit, information on therapy given after darunavir~     discontinuation will be collected. For patients discontinuing for virologic failure, data~     will be collected until the end of the present study, and at least two consecutive~     measurements of viral load after starting new antiretroviral therapy will be collected, if~     available. All data collected must be the result of the normal medical care of the patient.~     The patient's baseline data will be collected within the first week before darunavir~     administration (at Visit 1). For patients already in treatment with darunavir, baseline and~     follow up data will be collected retrospectively and prospectively. Further data collection~     will occur approximately at 1, 3, and 6 months and subsequently about every 3 months~     according to routine practice, after initiating darunavir treatment.~   "
167300|NCT01375868|"~     Vaccines against human papillomaviruses are now commercially available. One of the commercial~     vaccine contains antigens of both LR HPV types which cause virtually all cases of RRP.~     Clinical trials have documented the safety and immunogenicity of this vaccine as well as its~     effectiveness in prevention of incident and persistent infection of the vaccinal types as~     well as a development of lesions caused by these types. After vaccination the antibodies~     level increases dramatically and the high levels of antibodies are present in the blood still~     after 6 years. Furthermore, the neutralization antibodies to the vaccinal antigens have been~     detected in the cervical mucus of vaccinated women. The preliminary data are now available~     showing the presence of HPV-specific antibodies in the oral cavity in women after~     vaccination. The level of antibodies has been dependent on time since vaccination.~   "
167301|NCT01375855|"~     Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent~     implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion~     (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by~     means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months~     follow-up. The investigators sought to compare the two stent types with the same drug to~     verify the polimer role. The polimer itself seems to provoke inflammation and~     hypersensibility if the arterial wall and it seems to be the base of a process of positive~     remodeling found at drug eluting stent implantation site.~      This positive remodeling is the mechanism producing late stent malapposition which on its~     turn can determine stent thrombosis, as demonstrated by pathological studies. At the same~     time the investigators will study the incidence of clinical events like myocardial~     infarction, stent thrombosis, TLR and death along with the incidence of angiographic~     restenosis at 2 years follow up.~   "
167302|NCT01375842|"~     This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate~     the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as~     single agent to participants with locally advanced or metastatic solid malignancies or~     hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort~     and Expansion cohort.~   "
167303|NCT01375829|"~     This phase I trial studies the side effects and best dose of ixabepilone and temsirolimus in~     treating patients with solid tumors that have spread from the primary site to other places in~     the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ixabepilone,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     ixabepilone together with temsirolimus may kill more tumor cells.~   "
167304|NCT01375816|"~     RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated irinotecan hydrochloride~     PEP02, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. It is not yet known whether giving liposome-encapsulated irinotecan hydrochloride~     PEP02 together with leucovorin calcium and fluorouracil is more effective than giving~     irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line~     therapy in treating patients with metastatic colorectal cancer.~      PURPOSE: This randomized phase II trial is studying liposome-encapsulated irinotecan~     hydrochloride PEP02 given together with leucovorin calcium and fluorouracil to see how well~     it works compared with giving irinotecan hydrochloride together with leucovorin calcium and~     fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.~   "
167314|NCT01375686|"~     The study will complete up to 500 subjects across 9 clinical sites to evaluate the precision~     and accuracy of SCOUT DS (Diabetes Screening) subjects at risk for type 2 diabetes. The study~     will involve up to two unique Scout devices at each clinical site. Each site will initially~     contain only a CS-1 (Commercial SCOUT 1) A for collection of data. As they become~     available, CS-1 Bs operating with latest version of SCOUT software will be shipped to each~     site.~      The NSEEDS study will enroll patients at-risk for type 2 diabetes who meet the study~     inclusion criteria (and do not meet one or more of the exclusion criteria) at approximately 9~     clinical sites distributed across the United States. Eligible subjects must be at least 18~     years old, not have an existing diagnosis of diabetes and, if less than 45 years old, must~     have a body mass index (BMI) ≥ 25 and at least one other risk factor for type 2 diabetes.~      The data will be collected and a partial area under the receiver operator curve (pAUC) will~     be computed via the method of moments between the 20% and 50% false positive rates based on~     the first valid Scout A measurement for each patient. The impaired glucose tolerance status~     will be determined by the average of the two hour, post challenge plasma glucose samples~     measured at the central laboratory. This will be compared to 1000 bootstrap re-samplings of~     the calibration data pulling a cohort that matches that collected during this study. A test~     will be conducted to assure that the SCOUT performance lies within a 95% empirical confidence~     interval based on the bootstrap re-sampling.~   "
167315|NCT01375673|"~     Heart Failure (HF) is a significant healthcare concern in the US, with a 120% rise in~     mortality rates over 15 years costing the country an estimated $37.2 billion in 2009.~     Veterans are currently impacted at a rate of 5.2%, and cost an average of~     $14,959/individual/year for those utilizing the VA's Healthcare services. Research has shown~     that exercise training (ET) improves aerobic capacity, endothelial dysfunction, quality of~     life, and the ability to tolerate activity within the overall HF population. The purpose of~     this study is to examine the effects of structured exercise training and specific types of~     exercise training, walking, bicycling, and resistance training, on the symptom of fluid~     volume over load or edema in advanced heart failure patients.~   "
167316|NCT01375660|"~     This study will supplement African American male (AAM) veterans at risk for diabetes and~     newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D helps~     to improve early markers of diabetes. The study will be done at Veteran Administration~     Medical Center in Chicago.~   "
167317|NCT01375647|"~     Oral polio and rotavirus vaccines are significantly less effective in children living in the~     developing world. Tropical enteropathy, which is associated with intestinal inflammation,~     decreased absorption and increased permeability, may contribute substantially to oral vaccine~     failure in developing country settings. Other possible causes of oral vaccine~     underperformance include malnutrition, interference with maternal or breastmilk antibodies,~     changes in gut microbiota, and genetic susceptibility.~      Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral~     polio and rotavirus vaccines in children in Bangladesh.~      Secondary Objectives: 1) to determine the impact of an inactivated polio vaccine (IPV) boost~     on the efficacy of oral polio vaccine and 2) to determine the efficacy of oral rotavirus~     vaccine to prevent rotavirus diarrhea~      The polio and rotavirus randomized clinical trials are embedded as secondary objectives~     within the exploratory study of tropical enteropathy. The primary and secondary outcome~     measures are relevant to the randomized clinical trials.~   "
167318|NCT01375634|"~     Nasogastric tube placement involves insertion of a flexible tube through the nose into the~     stomach. Placement of the tube can irritate the nose and palate and trigger gagging, causing~     discomfort, even if topical or local anesthetics are used. This study aims to determine if~     administration of an ultra-short acting sedative agent (midazolam) into a vein before the~     procedure, in addition to topical local anesthetic, will decrease the level of discomfort.~   "
167319|NCT01375621|"~     Background:~      - MRSA is a type of bacteria that causes serious health problems. It can cause severe~     infections and is difficult to treat. MRSA has been found in a high number of people who work~     with some kinds of livestock, such as pigs. Researchers want to study people in rural areas,~     where more people work with or around livestock. They want to see if MRSA is more common or~     causes more serious infections in these areas.~      Objectives:~      - To look at the relationship between livestock handling (especially pigs) and MRSA bacteria~     in people in rural areas.~      Eligibility:~        -  Participants in the Agricultural Health Study in Iowa, including those who are exposed~          to livestock.~        -  Healthy volunteers who are not exposed to livestock.~      Design:~        -  This study requires an initial visit and monthly follow-up surveys for 18 months.~        -  At the first visit, participants will have throat and nose swabs to collect cell and~          bacteria samples. They will also complete a questionnaire about their health habits.~          Other questions will ask about any work that brings them into contact with livestock~          like cows, pigs, or chickens.~        -  Every month for the next 17 months, participants will complete another questionnaire to~          record any changes in their health and livestock contact information. They will also~          collect throat and nose swabs. They will send the questionnaires and the swabs to the~          study researchers.~        -  Participants will be paid for the first visit and for every monthly survey and swab~          collection they return.~        -  No treatment will be given as part of this protocol....~   "
167320|NCT01375608|"~     Background:~        -  In sickle cell disease (SCD), the proteins in the red blood cells that carry oxygen do~          not behave normally. In parts of the body where there are low levels of oxygen or where~          oxygen is used more, the sickle hemoglobin proteins may change shape and stick together.~          This causes the red cells to clump, which reduces blood flow. This leads to even lower~          oxygen levels and causes damage and/or pain.~        -  One way to stop the red blood cells from sticking together is to increase the levels of~          fetal (baby or good ) hemoglobin. The good hemoglobin then takes the place of the sickle~          hemoglobin.~        -  Hydroxyurea is the only approved drug for SCD. But hydroxyurea works in only about~          two-thirds of people with SCD. Even in those cases it sometimes stops working over time.~        -  Researchers are interested in testing decitabine. The drug may help to increase fetal~          hemoglobin levels. But it has not yet been approved to treat SCD.~      Objectives:~      - To test the safety and effectiveness of decitabine in increasing fetal hemoglobin levels~     and improving the symptoms of sickle cell disease.~      Eligibility:~      - People at least 18 years of age who have sickle cell disease that has not improved after at~     least 6 months of hydroxyurea therapy. Those who cannot take hydroxyurea because of side~     effects may also participate.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests, a lung function test, and other tests as required.~        -  Participants will receive decitabine injections up to twice a week for 1 year. Depending~          on the response to treatments, the dose will remain the same or be reduced to once a~          week.~        -  Participants will be monitored with frequent blood tests and other studies as directed~          by the study doctors.~        -  After the study is completed, participants will go back to their usual sickle cell care.~          If decitabine has improved a participant's SCD, treatment may be continued under regular~          health coverage insurance if this can be arranged.~   "
167321|NCT01375595|"~     Background:~      - Studies have shown that animals such as monkeys and dogs have excellent sight and touch~     memory but perform poorly on sound memory tasks. Human brains have certain areas that are~     important for speaking and understanding language. These areas may be involved in sound and~     spoken word memory. Researchers want to study these areas of the brain to find out if the~     memory for sounds requires brain structures that are usually associated with language~     learning and are unique to humans.~      Objectives:~      - To use magnetic resonance imaging to study areas of the brain involved in sound memory.~      Eligibility:~      - Healthy right-handed volunteers between 18 and 50 years of age. They must be native English~     speakers and have completed high school.~      Design:~        -  The study requires a screening visit and 1 or 2 study visits to the National Institutes~          of Health Clinical Center.~        -  At the screening visit, volunteers will have a medical history taken. They will also~          have physical and neurological exams, and complete a questionnaire. Women of~          childbearing age will give a urine sample. Participants who have not had a magnetic~          resonance imaging (MRI) scan in the past year will have one at this visit.~        -  At the second visit, participants will have tests of sound memory. They will listen to a~          set of nonsense words spoken through earphones and memorize the words. Then they will~          listen to the words again to judge if the words were part of the earlier list.~          Participants will have a 1 hour break, then do the sound memory test again. During the~          second test they will have repetitive transcranial magnetic stimulation (rTMS), which~          stimulates different regions of the brain.~        -  If the group results from the testing sessions are positive, there will be a third~          visit. At this visit, participants will have a sound perception test. They will listen~          to words spoken through earphones and judge whether the words in the pair are the same~          or different. Participants will have rTMS during these tests as well.~   "
167322|NCT01375582|"~     This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.~   "
167323|NCT01375569|"~     Background:~      - TRC105 is an experimental cancer drug. It is designed to slow or stop the growth of tumors.~     It does this by preventing the growth of new blood vessels that feed these tumors. People~     with hepatocellular carcinoma (or liver cancer) sometimes do not respond to standard~     treatments. This includes the cancer drug sorafenib.~      Objectives:~      - To test the safety and effectiveness of TRC105 to treat liver cancer that has not responded~     to standard therapy.~      Eligibility:~        -  People at least 18 years of age who have hepatocellular carcinoma (or liver cancer) that~          has not responded to standard therapy. Participants also will not be eligible for a~          liver transplant.~        -  No anticoagulation therapy is allowed with the exception of low-dose aspirin.~        -  No history of bleeding disorders, peptic ulcer disease or gastritis.~      Design:~        -  Participants will have a physical exam and medical history. They will also have blood~          and urine tests, and imaging studies.~        -  Participants will receive TRC105 once a week. They will also have two daily doses of a~          steroid the day before each treatment. This will help prevent known side effects.~        -  Participants will be monitored with blood and urine tests. They will also have imaging~          studies every two months to study the effect of the drug on tumor growth.~        -  Participants will continue to have TRC105 as long as they do not have severe side~          effects and their liver cancer stops growing or shrinks. After stopping TRC105, they~          will have yearly visits with physical exams and blood tests.~   "
167324|NCT01375556|"~     Background:~      - Previous research has shown that a person s genes can influence how they respond to~     alcohol. But researchers do not yet know all the genes that might be involved.~      Objectives:~      - To identify genes that are related to how non-alcoholic individuals respond to alcohol.~      Eligibility:~      - Healthy people between 21 and 30 years of age who have no history of alcohol or drug~     dependence.~      Design:~        -  The study requires one or two 9-hour visits to the National Institutes of Health~          Clinical Center.~        -  Participants must not take any medicines (except birth-control pills for women) for at~          least 3 days before the visit. They must not drink alcohol for at least 2 days before~          the visit.~        -  Screening includes a medical history, physical exam, and a urine test for drugs of~          abuse.~        -  Participants will be given alcohol over about 2.5 hours. This will have about the same~          effect as having three to four drinks. Frequent breathalyzer tests will check breath~          alcohol level during the infusion.~        -  Before and during the infusion, participants will complete questionnaires about mood and~          feelings. Other tests will study thinking, balance, judgment, and risk-taking. Blood~          samples will be collected four times during the infusion.~        -  Participants will have breakfast at the start of the visit (around 8:00 AM). They will~          have a snack before the start of the alcohol infusion (around 10:45 AM). Lunch will be~          served after the alcohol infusion is complete (around 2:20 PM). After the tests, those~          in the study will have to stay in the Clinical Center until their breath alcohol level~          falls below 0.02%. This can take up to 2.5 hours. A final blood sample will be drawn at~          that time. Participants will not be able to drive themselves home after the study~          visits. Also, they should not take any medicines or operate any machinery for at least 2~          hours after leaving NIH.~   "
167325|NCT01375543|"~     Background:~      - The purpose of this study is to identify changes in genes that cause human diseases. We~     would like to obtain some of you or your child s DNA and test for changes in genes that may~     contribute to a disease in you or your family.~      Objective:~      -To allow for exomic or genomic sequencing of NICHD patients or family members in order to~     identify changes in genes that cause or contribute to a specific disease.~      Eligibility:~        -  Children who are enrolled in an NICHD clinical study where the condition being studied~          may have a genetic cause.~        -  Family members of a child who is eligible for this study.~      Design:~        -  Children and family members will supply DNA samples. If the samples are already~          available, no further DNA will be needed.~        -  If DNA is not available, samples of either blood or skin will be taken.~        -  We will use these samples with new DNA sequencing technology that looks at all the human~          genes we know about. This is known as exome and genome sequencing.~   "
167326|NCT01375530|"~     Background:~      - The National Institute of Allergy and Infectious Diseases (NIAID) at the National~     Institutes of Health needs healthy volunteers for vaccine clinical trials. These trials will~     allow researchers to study vaccines and injection devices. These studies will also allow~     researchers to understand the immune system and how vaccines work. In this protocol,~     researchers will screen healthy volunteers for these future trials.~      Objectives:~      - To screen healthy volunteers for clinical trials at the NIAID.~      Eligibility:~      - Healthy people between 18 and 70 years of age. They must be available to take part in~     clinical trials and be able to provide blood for research studies.~      Design:~        -  Screening for a clinical trial may begin several months before the vaccine clinical~          trial begins.~        -  Volunteers will be screened with a physical exam and medical history. They may also~          answer questions about sexual activity and drug use.~        -  Volunteers will provide blood samples and possibly urine samples. They may have other~          tests as needed for the study.~        -  Volunteers will not receive any treatment in this screening trial.~   "
167327|NCT01375504|"~     This study is designed to assess the effect of a mindfulness training program with special~     focus on diet and nutrition vs. dietary counseling in 40 obese adults (BMI range 30-40) and~     their partner/spouses (irrespective of their BMI), in a 6-month pilot randomized controlled~     trial.~   "
167328|NCT01375491|"~     Obesity is a heightened state of inflammation in which production of cytokines and matrix~     metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin~     resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance~     insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes~     (DM2).~   "
167332|NCT01375439|"~     Introduction: Preterm labor (PTL) is an important obstetric intercurrence that affects 5 to~     10% of pregnancies. Among the known factors of PTL etiology are PTL occurrence in previous~     pregnancies, multiple pregnancies, polyhydramnios, vaginal bleeding during pregnancy,~     premature membrane rupture (PMR) and bacterial vaginosis. Despite the advancement achieved in~     Neonatology, morbidity and mortality resulting from high rates of preterm births have~     remained constant in the last few decades. Objective: This study aims at evaluating maternal~     and perinatal outcomes of pregnant women with a history of preterm labor in previous~     pregnancies and submitted to active search for vaginal infection. Material and Method: It is~     a prospective-cohort epidemiological study to be conducted in Botucatu/SP. Two study groups~     (G1 and G2) will be formed, and each of them will comprise 140 pregnant women with a history~     of preterm childbirth. G1 will be related to the active search and etiological diagnosis of~     lower genital tract infections, and G2 will be related to non-search for such infections, for~     which the routine care protocol of primary health units in the city of Botucatu will be~     maintained. Care propedeutics for the pregnant women (G1) will include the performance of~     direct examination of vaginal content stained by the Gram method, culture in Diamonds medium,~     polymerase chain reaction (PCR) of endocervical secretion collected in the primary health~     care services in the city at two moments: prior to the 20th gestational week (M1) and at the~     36th week (M2). Moment M3 will take place after childbirth for evaluation of the perinatal~     outcome.~   "
167333|NCT01375426|"~     Over a period of years there have been numerous reports from many developing countries~     including Pakistan showing a rising treatment failure rate with first line drugs (amoxicillin~     and cotrimoxazole) in non-severe pneumonia in children. The reasons for this rise in~     treatment failure rates are not entirely clear but one of the reasons is thought to be~     increasing antimicrobial resistance of H. influenzae and Strep. pneumoniae to first line~     drugs. There is microbiological data which suggests that this resistance can be overcome by~     increasing the dose of amoxicillin. The investigators propose to treat non-severe pneumonia~     with double dose amoxicillin in an attempt to demonstrate a decrease in treatment failure~     rates. This will be a multicentre, double blind randomized controlled trial in children 2-59~     months of age with non-severe pneumonia comparing the clinical outcome between the standard~     and double dose groups.~      It has been felt that the WHO criteria for treatment failure in children with pneumonia are~     too stringent and have never been systematically evaluated in the community. The~     investigators also propose to modify WHO criteria and field test them in this trial in an~     attempt to demonstrate that less stringent treatment failure criteria would have an impact on~     the overall treatment failure rates in pneumonia.~      Hypothesis:~      Therapy outcome with double dose of oral amoxicillin is not different than the standard dose~     of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2-59~     months old children.~   "
167334|NCT01375413|"~     The ability to perform two or more tasks together is impaired in Parkinson's Disease (PD).~     Based on pilot work we hypothesize that dual tasking is amenable to training in PD and will~     not compromise safety. In the proposed study we will therefore collect high level evidence on~     whether 6 weeks of integrated dual task gait training is more effective than consecutive task~     practice. The investigators will use a randomized, single blind study design and conduct the~     same protocols in two academic centers (Katholieke Universiteit Leuven and Radboud~     Universiteit Nijmegen). The investigators intend to test an experimental condition which~     consists of focused dual task training in the home using a novel program of personalized~     cognitive tasks. The aim of dual task training is to teach motor-cognitive task integration~     and achieve optimal levels of automaticity and functionality. The control arm will receive~     gait practice and separate cognitive training of the same intensity, but offered~     consecutively. We will test the hypothesis that dual task training (integration) will have~     more pronounced effects on complex gait than consecutive task training.~      Sub-analysis will be conducted on patients with and without freezing of gait. The~     investigators expect that integrated dual task training may be less effective in patients~     with freezing, due to the increased fall risk and impaired cognitive profiles.~      Overall, this project will provide evidence to support future directions for motor learning~     and innovative rehabilitation targets.~   "
167335|NCT01375400|"~     Aspirin is the only anti-platelet medication used at the acute phase of ischemic stroke. The~     investigators would like to study laboratory effect of the first oral 300 mg dose of aspirin,~     given at hospital, after an ischemic event.~      The principal hypothesis is that platelet activity would be able to recover during this day~     and could lead to ischemic recurrences.~      Two blood samples are accomplished. The first 2 hours after aspirin intake and the second 23~     hours after. Photometric aggregometry are performed with arachidonic acid and collagen~     induced platelet aggregation, measure of thromboxan B2 levels and reticular platelets count.~   "
167336|NCT01375387|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in~     healthy male Chinese and Japanese subjects.~   "
167337|NCT01375374|"~     The purpose of the trial is to investigate whether changes in lipids and hormonal parameters~     can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment,~     while Levetiracetam treatment remains unchanged.~   "
167338|NCT01375361|"~     This is a randomized trial of the use of Albuterol in the setting of acute decompensated~     Congestive Heart Failure with radiographic evidence of Cardiogenic Pulmonary Edema.~   "
167339|NCT01375348|"~     Patients with chronic pain can experience considerable changes in their cognitive function~     such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and~     morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead~     to worsening of the cognitive function. The interaction between pain, treatment and cognitive~     function is very complex and is far from understood.~      The hypothesis of the present study is that by use of experimental pain in healthy volunteers~     it will be possible to elucidate the interaction between pain, treatment and cognitive~     function.~   "
167340|NCT01375335|"~     The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly~     intact contraction of the heart. This study aims to elucidate the efficacy of low-dose~     dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.~   "
167341|NCT01375322|"~     The purpose of the study is to compare the change from baseline in blood pressures (DBP/SBP)~     to 16-week regimen between Amtrel® and Co-Diovan®. The secondary objectives were listed as~     the following.~        -  To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end of~          study~        -  To evaluate the change from baseline in albumin-to-creatinine ratio with~          antihypertensive medications in whole group (combined treatment groups) and each~          treatment group (Amtrel®, Co-Diovan®) at Week 16~        -  The change from baseline in glycosylated hemoglobin (HbA1c) at Week 16~        -  The change from baseline in fasting plasma glucose (FPG) at Week 16~        -  The change from baseline in fasting lipid profiles (triglyceride, total cholesterol,~          high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) at Week 16~        -  The change from baseline in arteriosclerosis marker (brachial-ankle pulse-wave velocity~          (ba-PWV) and ankle-brachial pressure index (ABI), using Colin-VP1000) at Week 16~        -  The change from baseline on the body mass index (BMI) and waist-hip ratio (WHR) at each~          specified study time point~        -  To ascertain the safety and tolerability of Amtrel® versus Co-Diovan® including AE/SAE,~          and laboratory examinations~   "
167342|NCT01375309|"~     Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal~     intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm~     infants who received Bifidobacterium bifidum early after birth. In order to evaluate these~     beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is~     conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to~     preterm infants improve enteral feeding and growth in very low birth weight infants.~   "
167343|NCT01375296|"~     Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with~     significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary~     syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and~     the effect of SES in these patients remains unclear. Here the investigators hypothesize that~     application of China-made SES may improve the clinical outcomes in these setting.~   "
167344|NCT01375283|"~     This is a prospective observational cohort study on changes in sensory mapping.~   "
167345|NCT01375270|"~     Elevations of blood glucose and lipid are thought to be deleterious to the insulin secretory~     function of the pancreas. This is known as glucolipotoxicity. However, few studies have~     examined this in detail. This investigation will examine pancreatic insulin secretory~     function in physiological models of glucolipotoxicity such as obese and type 2 diabetic~     individuals. Furthermore, healthy subjects will undergo 24 hour infusion of glucose or~     Intralipid to induce experimental models of glucolipotoxicity. Insulin secretion in response~     to intravenous infusions of glucose, GLP-1, GIP, and arginine and in response to meal~     ingestion, will be examined. the investigators hypothesize that experimental~     glucolipotoxicity will impairs pancreatic insulin secretory function to levels akin to that~     seen in type 2 diabetics.~   "
167346|NCT01375257|"~     Background Current management of infective endocarditis include admission and treatment with~     parenteral antibiotics for 4 weeks - 6 weeks. Resource demands and psychological issues of~     present management strategy make it highly relevant to seek for alternative more lenient~     alternatives. Experiences with oral treatment are only sporadically described, but~     observational data suggest that oral treatment could be a feasible option. The investigators~     have in 2010 treated 12 endocarditis patients with partial oral antibiotics with a 100%~     success rate.~      Study design The POET study is a Danish multicenter, prospective, randomized, open label~     study. The primary aim is to show non-inferiority of partial oral treatment with antibiotics~     of endocarditis compared to full parenteral treatment. Stable patients (n=400) with~     streptococci, staphylococci or enterococci infecting the mitral valve or the aortic valve~     will be included. After a minimum of 10 days of parenteral treatment, patients will be~     randomized to oral therapy or parenteral therapy. Special recommendations for oral treatment~     have been developed based on expected minimal inhibitory concentrations and pharmacokinetic~     calculations. Patients will be followed for 6 months after completion of antibiotic therapy.~     The primary endpoint is a composition of all cause mortality, unplanned cardiac surgery,~     embolic events and relapse of positive blood cultures with the primary pathogen.~   "
167347|NCT01375244|"~     The purpose of this study is to compare the bioavailability of Par Lisinopril 10 mg Tablets~     and IPR Pharmaceuticals, Inc. Zestril (R).~   "
167348|NCT01375231|"~     The investigators posit that it would be advantageous to reproduce the height of the entire~     patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its~     preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient.~     For example the quadriceps mechanism would have to work harder if the total patellofemoral~     (PF) height is diminished. Alternatively, diminished motion or increased patellar strain may~     occur if the overall PF height is increased. The investigators theorize that either of these~     sizing errors could lead to anterior knee pain. The purpose of this study is to compare the~     clinical outcomes between two surgical techniques: 1) a technique of reproducing the total PF~     joint on both sides of the articulation (Group 1) and 2) the traditional technique of~     reproducing only the patellar thickness on one side of the joint (Group 2).~   "
167349|NCT01375218|"~     The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction~     brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip~     (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and~     the Pavlik harness. The investigators hope to learn which brace treatment is best for a~     definable population so the appropriate brace can be chosen initially avoiding the time,~     expense, and frustration of a failed technique.~   "
167350|NCT01375205|"~     The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on~     babies' skin versus Johnson & Johnson baby lotion and skin cleanser.~   "
167351|NCT01375179|"~     This study is designed as a proof of concept of KRP203 for induction of remission in~     ulcerative colitis (UC). The purpose of this study is to evaluate clinical benefit of KRP203~     in subjects with moderately active refractory ulcerative colitis.~      The study will provide safety and tolerability data in this subject population up to eight~     weeks of treatment with KRP203. Additionally, this study will evaluate the duration of a~     clinical response to KRP203 by following up responding subjects for an additional 12 weeks.~   "
167352|NCT01375166|"~     The prevalence of diabetes is increasing and the management of the disease is nowadays~     considered a major challenge. Affected patients have increased mortality and morbidity as~     well as a significant drop in the quality of life. The complications of diabetes can be~     classified as microvascular (e.g. nephropathy, neuropathy or retinopathy) or macrovascular~     (e.g. cardiovascular or cerebrovascular).~      Several large-scale epidemiologic studies indicating that wider retinal venous caliber is~     strongly associated with the fasting glucose level as well as with diabetes. Another retinal~     vascular abnormality that is associated with diabetes is an abnormal retinal vascular~     response to flicker stimulation. Retinal vessel dilatation in response to stimulation with~     diffuse flicker light occurs due to a phenomenon called neurovascular coupling. This means~     that increased activity of neurons is associated with an increased retinal metabolism. This~     leads to a release of endogenous vasodilator substances and increased blood flow. However,~     previous studies were limited by the fact that retinal vessel diameters and blood flow were~     not measured simultaneously.~      The present study aims to investigate whether the response of retinal vessel diameters and~     blood flow velocities to flicker stimulation is altered in patients with diabetes. Both~     parameters will be measured in real time using Fourier Domain Doppler OCT.~   "
167353|NCT01375153|"~     Chronic heart failure is accompanied by anorexia and increased release of B-type natriuretic~     peptide (BNP) from the ventricular myocytes. The pathophysiological mechanisms linking heart~     failure and appetite-regulation remain unknown. This study aims to examine the impact of~     exogenous BNP administration on subjective ratings of hunger and satiety, and on~     appetite-regulating hormones in a placebo-controlled cross-over study performed in ten~     healthy human volunteers.~   "
167354|NCT01375140|"~     The goal of this clinical research study is to learn if the combination of ruxolitinib and~     lenalidomide can help to control MF. The safety of this study drug combination will also be~     studied.~      Ruxolitinib is designed to stop certain proteins (called JAK1 and JAK2) that are found in MF~     cells from sending signals that may lead to the growth of cancer cells.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~   "
167355|NCT01375127|"~     This is an observational study designed to collect follow-up clinical date on subjects who~     were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued~     treatment prematurely or did not elect to enroll in long-term extension studies.~   "
167356|NCT01375114|"~     The goal of this clinical research study is to learn if panax ginseng (commonly called~     ginseng) can help to control fatigue and other symptoms such as depression, anxiety, and mood~     changes in patients with cancer. The safety of ginseng will also be studied.~   "
167357|NCT01375101|"~     Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an immunologic~     etiology ,which has number of different clinical forms. Alternative natural or herbal origine~     drugs with antioxidant and anti-inflammatory properties have been used individually or in~     combination with systemic corticosteroids in order to decrease adverse drug reactions.~      This study was conducted to evaluate the effect of quercetin on treatment of erosive~     -atrophic lesions of oral lichen planus (OLP).~   "
167358|NCT01375088|"~     The purpose of this study is to determine whether propolis is effective in the treatment and~     prevention of radiotherapy induced oral mucositis.~   "
167359|NCT01375075|"~     The purpose of this study is to determine if 12 weeks of treatment with LY2484595~     administered as a monotherapy will significantly increase high-density lipoprotein~     cholesterol (HDL-C) and decrease low-density lipoprotein cholesterol (LDL-C) in Japanese~     participants.~   "
167360|NCT01375062|"~     The purpose of this study is to isolate and culture stem cell from adult human testicular~     biopsies for future transplantation in fertility preservation.~   "
167361|NCT01375049|"~     This is an open-label, multi-center study in pediatric patients age 3 months to less than 18~     years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary~     colonization/infection. All eligible participants will be treated with a 28-day course of~     Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug,~     subjects will be followed up through Day 196 for safety and recurrence of PA.~      The primary objective is to evaluate the proportion of participants with PA-negative cultures~     at all time points during a 6-month monitoring period (through Day 196) after cessation of~     AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI~     treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after~     completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).~   "
167362|NCT01375036|"~     This is a prospective, longitudinal, 5-year study that will enroll participants from the~     existing Cystic Fibrosis Foundation (CFF) patient registry. Each enrolled participant will~     provide samples for microbiological evaluation, obtained upon enrollment and then once per~     year thereafter for 5 years.~   "
167363|NCT01375023|"~     The purpose of this study is to evaluate the engraftment, toxicity and anti-tumour activity~     of allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG~     conditioning regimen in patients with refractory Triple Negative breast cancer.~   "
167364|NCT01375010|"~     The purpose of this study is to determine the effects of vitamin D on measures of bone health~     and immune function in HIV infected postmenopausal women. The investigators prior research~     with this population revealed that low vitamin D levels are very common. Prior research with~     this population also revealed that Vitamin D is necessary for the body to absorb calcium and~     is important for the health of the bones. When vitamin D levels are low, there are increased~     risks of bone loss, muscle weakness, falls and fractures. Low levels of vitamin D have also~     been associated with impaired immune function. This study will help us learn whether two~     different doses of vitamin D will improve bone health and immune function.~   "
167403|NCT01374477|"~     Hypertensive disorders of pregnancy are one of the most frequent complications of pregnancy,~     being a serious health problem around the world.~      Previous studies have suggested that there is an association between a short period of~     exposure to paternal sperm of a new sexual partner and the development of an immunological~     reaction that could trigger a hypertensive disorder of pregnancy. For this reason we want to~     study the relationship between the primipaternity concept (exposure to male antigens present~     in semen over a short period of time previous to the pregnancy) and the development of~     preeclampsia in adolescents.~   "
167365|NCT01374997|"~     Fabry disease is a rare genetic disease characterized by an enzyme deficiency, called~     alpha-galactosidase A, which normally breaks down a lipid, is missing or does not function~     properly. As a result, the lipid accumulates in the body, this leads to multisystem~     impairment, including progressive renal failure.~      Several studies have focused on the detection of this disease in end-stage renal failure~     patients, transplant or hemodialysis.~      This study aims to diagnose the Fabry patients earlier, among men aged 18-60 years with a~     glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90~     and 60 ml/min/1, 73m2 in association with proteinuria greater than 0.3 g / g or creatinine~     level greater than 0,5 g/l.~      This screening will be conducted by a blood test to measure the level of alpha-galactosidase~     A activity by micromethod from samples taken from blood spots on filter paper. If this assay~     was positive, confirmation of diagnosis of Fabry disease will done the standard method:~     macrodosage of leukocytic alpha-galactosidase A activity.~      This multicenter prospective study, openly contacted in medical practice, with patient~     follow-up corresponding to the management of renal insufficiency, will be offered to all~     departments of nephrology and dialysis for adults in the Provence - Alpes - Côte d'Azur.~      The objective of this study is to assess the prevalence of Fabry disease in the target~     population and to identify previously undiagnosed patients, enabling them to benefit from~     appropriate management of their disease, including whether need enzyme replacement therapy.~   "
167366|NCT01374984|"~     This is a post-marketing study to verify the clinical benefits of VIGIV [CNJ-016, Vaccinia~     Immune Globulin Intravenous (Human), sterile solution] in the resolution of complications~     resulting from smallpox vaccination in eligible patients treated with VIGIV.~   "
167367|NCT01374971|"~     The purpose of this study is to conduct an Investigator-Sponsored Study to determine the~     potential immunomodulatory effects of Certolizumab Pegol (CZP) treatment at the site of~     disease activity (synovial lining) in subjects with rheumatoid arthritis (RA), using pre~     treatment and post treatment arthroscopic synovial biopsies and ex vivo on gene expression.~   "
167368|NCT01374945|"~     Use of Clearpath to facilitate successful completion of colonoscopy procedures with~     sub-optimal preparation.~   "
167369|NCT01374932|"~     The CPASMA trial is a descriptive, prospective, multicentre clinical trial, with a~     before/after Continuous Positive Airway Pressure (CPAP) assessment in participating patients.~     It aims to answer the following question: Is there an improvement in asthma in those patients~     with both asthma and obstructive sleep apnoea syndrome (OSAS) treated with CPAP after six~     months?. It is hypothesized that treatment of OSAS with CPAP in patients with both OSAS and~     asthma concommitantly, may have a beneficial effect also on asthma outcomes. This clinical~     effect in asthma could be assessed objectively by applying validated questionnaires for~     quality of life and asthma control.~   "
167370|NCT01374919|"~     The aim of the study is to recruit 30 patients who have been referred to Auerach Hematology~     Oncology Assoc. for the treatment of iron defeciency anemia with iv iron (Ferumoxytol 1020~     mg) administered via infusion pump over 15 minutes.~      To ascertain acute safety and tolerability of ferumoxytol during immediate post dosing~     observation period.~      Assess additional safety profile and laboratory assessment at follow up visit and interim~     telephone follow up.~   "
167371|NCT01374906|"~     This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and~     efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with~     Cushing's disease.~   "
167372|NCT01374893|"~     Background The Activity in GEriatric acute CARe (AGECAR) is a randomized control trial to~     assess the effectiveness of an intrahospital strength and walk program during short hospital~     stays for improving functional capacity of patients aged 75 years or older.~      Methods Patients aged 75 years or older admitted for a short hospital stay (≤14 days) will be~     randomly assigned to either a usual care (control) group or an intervention (training) group.~     Participants allocated in the usual care group will receive normal hospital care and~     participants allocated in the intervention group will perform multiple sessions per day of~     lower limb strength training (standing from a seated position) and walking (10 min bouts)~     while hospitalized. The Primary outcome to be assessed pre and post of the hospital stay will~     be functional capacity, using the Short Physical Performance Battery (SPPB), and time to walk~     10 meters. Besides length of hospitalization, the secondary outcomes that will also be~     assessed at hospital admission and discharge will be pulmonary ventilation (forced expiratory~     volume in one second, FEV1) and peripheral oxygen saturation. The secondary outcomes that~     will be assessed by telephone interview three months after discharge will be mortality,~     number of falls since discharge, and ability to cope with activities of daily living (ADLs,~     using the Katz ADL score and Barthel ADL index).~      Results Results will help to better understand the potential of regular physical activity~     during a short hospital stay for improving functional capacity in old patients.~      Conclusions The increase in life expectancy has resulted in a large segment of the population~     being over 75 years of age and an increase in hospitalization of this same age group. This~     calls attention to health care systems and public health policymakers to focus on promoting~     methods to improve functional capacity of this population.~   "
167373|NCT01374880|"~     The objective of this work is to investigate and then to sequence new biomarkers in the~     plasma of patients presenting with dyspnea secondary or not to heart failure, and study their~     diagnostic and prognostic value.~   "
167374|NCT01374867|"~     The aim of CardShock Study is to recognise significant prognostic factors in order to detect~     patients with increased mortality risk to which one could possibly direct more intensive~     treatments.~      The study will provide clinical, functional and invasive haemodynamic measures with~     systematic serial sampling and evaluation. In addition, the knowledge on the pathophysiology~     of cardiogenic shock is increased.~   "
167375|NCT01374854|"~     Umbilical mesenchymal stem cells (UC-MSCs) infusion is supposed be a promising regeneration~     therapy with mild side effect as indicated by large quantities of animal experiments and some~     clinical trials. There are few UC-MSCs clinical trials with regard to diabetes mellitus. The~     investigators hypothesize that infusion of USC-MSCs may provide multiple signals for~     beta-cell regeneration and even re-differentiate into local tissues in diabetes mellitus~     patients, resulting in improvement of diabetic control, of which the effect may be promoted~     by concomitant infusion of bone marrow mononuclear cells and maximized by intra-arterial~     pancreatic infusion through angiography.~   "
167376|NCT01374841|"~     The purpose of this study is to determine if engraftment can be achieved safely in patients~     with high-risk hematologic malignancies who undergo non-myeloablative transplant with~     peripheral stem cells from Human Leukocyte Antigen (HLA) haploidentical donors with pre and~     post-transplant cyclophosphamide as immunosuppression.~   "
167417|NCT01374295|"~     In order to compare two different forms of patient education; patients who receive Lortab~     medication or prescription during their ED visit are randomized to receive either standard~     patient education (from healthcare provider) or video assisted education. After education,~     patient completes a survey, estimated to take 5 minutes to complete.~   "
167378|NCT01374815|"~     In this study, the investigators will be using The Online Advocate, a Web-based~     health-related social problems screening and referral tool, to explore the relationship~     between health-related social problems and children's diet quality among families with young~     children attending the Children's Hospital Primary Care Center. The Online Advocate consists~     of a 60-80 question screening survey for health-related social problems (such as food~     insecurity, employment and income, homelessness) and allows participants to select referrals~     for local health and social service agencies that might help them with the problems~     identified through the survey. Layered into The Online Advocate for this study is an~     adaptation of the Harvard Service Food Frequency Questionnaire (HSFFQ) that can assess~     children's diet quality. The investigators plan to recruit 350 parent/guardians of otherwise~     healthy children age 3-10 years who are presenting to the primary care center for routine~     well child care. Eligible parent/guardians will have the opportunity to take The Online~     Advocate (plus HSFFQ) on a laptop computer in the waiting area before seeing their~     pediatrician or healthcare provider. Participants will receive a small incentive for their~     time as well as written information on healthy nutrition and an age appropriate coloring book~     for the child. At one month, participants will be contacted by the study team by email or~     phone and asked follow up questions about the status of their health-related social problems~     identified through The Online Advocate and whether the referrals they received were helpful.~     Participants will receive a small incentive for their time, along with a reminder message~     promoting healthy nutrition for their child. At three months, participants will be contacted~     by the study team by email or phone and asked follow up questions about the status of their~     health-related social problems identified through The Online Advocate and whether the~     referrals they received were helpful. They will also re-take the adapted HSFFQ. Participants~     will receive another small incentive for their time. Participants will also have the~     opportunity to re-take The Online Advocate at three months, though this is optional. The~     investigators believe this pilot study will provide foundational knowledge about the~     intersection between health-related social problems and children's diet quality and may~     inform future research studies and interventions.~      Our Study Aims are:~        1. To use The Online Advocate to evaluate the association between health-related social~          problems and diet quality in children in a cross-sectional sample.~        2. To evaluate the relationship between resolution of health-related social problems using~          The Online Advocate and change in diet quality in children over a 3 month period.~      Our Study Hypotheses are:~        1. A greater number of health-related social problems per family will be associated with~          poorer diet quality in children at baseline.~        2. After 3 months, families demonstrating resolution of one or more health-related social~          problems addressed with The Online Advocate will demonstrate greater improvement in diet~          quality in children.~   "
167379|NCT01374802|"~     The objective of the current study is to investigate the effect of multiple oral daily doses~     of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with~     ritonavir.~   "
167380|NCT01374789|"~     The primary objective of the study is to assess the efficacy of the combination consisting of~     gemcitabine/cisplatin and panitumumab in patients with urothelial carcinoma and wild-type~     HRAS (non-mutated status). The progression-free survival rate at 12 months will be compared~     to expectations derived from historical data, which are verified by a randomised control~     group without the antibody.~   "
167381|NCT01374776|"~     Effect of intravenous iron substitution (iron carboxymaltose (Ferinject®), total dose 15 mg/~     kg (maximal dose: 1000mg) in 250 ml 0.9 % NaCl; intravenous infusion in 20 min)in non-anemic~     premenopausal women with iron deficiency on~      Primary objective:~      - Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of~     the lower leg muscle)~      Secondary objectives:~        -  Maximal oxygen uptake during a graded cycling exercise test and time to exhaustion at~          submaximal power during a constant-load cycling exercise test~        -  Plantarflexor muscle fatiguability as assessed by isokinetic dynamometry~        -  Trial with medicinal product~   "
167382|NCT01374763|"~     The aim of the study is to describe the effects of oxycodone/naloxone combination in~     comparison to oxycodone for the treatment of postoperative pain in patients undergoing~     cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and~     the need of laxatives will decrease.~   "
167383|NCT01374750|"~     The purpose of this study is to evaluate the anti-tumor effect of sirolimus-based~     immunosuppressive regimen in patients following living donor liver transplantation for~     hepatocellular carcinoma exceeding Milan criteria with respect to recurrence-free survival.~   "
167384|NCT01374737|"~     There are several recommended doses of dexmedetomidine for prevention of emergence agitation~     in children. In this study, the investigators examine ED50 in prevention of emergence~     agitation after tonsillectomy or adenoidectomy in children.~   "
167385|NCT01374724|"~     The prevalence of tobacco use in the military is too high. This study is designed to take~     advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and~     develop effective interventions to prevent tobacco relapse.~      Hypotheses or Research Questions:~        -  Are there differences in the rate of relapse between three groups participating in a~          tobacco abstinence maintenance intervention?~        -  Do the tobacco abstinence maintenance interventions delay relapse?~   "
167386|NCT01374711|"~     The human body knows a biphasic immunological reaction to sepsis. First, the pro-inflammatory~     reaction takes place, marked by the release of pro-inflammatory cytokines like TNF-α, as a~     reaction to the bacterial toxins. Secondly, the counter regulatory anti-inflammatory reaction~     arises. This phase is acting as negative feedback on the inflammation by inhibition of the~     pro-inflammatory cytokines. This is called immunoparalysis, a pronounced immunosuppressive~     state, which renders patients vulnerable to opportunistic infections. Most of the septic~     patients survive the initial pro-inflammatory phase, but die during this second~     stage.Research in the past has shown that immunostimulatory therapy with GM-CSF or IFN-γ has~     promising effects on the pro-inflammatory reaction during immunoparalysis ex vivo. Both drugs~     are known for their immunostimulatory effects. Recent pilot studies have showed in septic~     patients, that long-lasting monocyte deactivation in sepsis ex vivo can be reversed by these~     two immunostimulants. However, the mechanism and extent of immunoparalysis recovery may be~     different between the two compounds. Previously it has been shown that human endotoxemia~     (induced by LPS), leads to marked immunosuppression in healthy individuals, characterized by~     a transient refractory state to a subsequent LPS challenge (endotoxin tolerance).~     Consequently, human endotoxemia can serve as a standardized, controlled model for~     sepsis-induced immunoparalysis. Until now, all studies have focused on the ex vivo tolerance.~     However, we have recently proved, that the ex vivo condition is not completely representative~     for the in vivo situation. Ex vivo, leukocyte tolerance to LPS resolves within one day, while~     the in vivo immunoparalysis persists for two weeks. In this project, we will investigate the~     effects of both GM-CSF and IFN-γ in a parallel double-blind placebo controlled randomized~     manner on the immunoparalysis following human endotoxemia, both in-vitro and in vivo. As a~     result, we hope to get more insight in the pathophysiology of sepsis-induced immunoparalysis~     and thereby develop new immunostimulatory therapies that improve patient outcome~   "
167387|NCT01374698|"~     This is a prospective, randomized study conducted in patients undergoing coronary~     revascularization procedures (PCI) through angioplasty. All patients who meet the eligibility~     criteria will be randomized to receive, before the procedure, an oral aspirin reload (325 mg)~     and to be re-evaluated at 60 minutes, 120 minutes, 6 hours, 48 hours, 5 and 30 day, 3 and 6~     months.~   "
167400|NCT01374516|"~     The aim of the study is to assess the efficacy of sanofi pasteur's CYD dengue vaccine in~     preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin~     America.~      Primary Objective:~      To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in~     preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due~     to any of the four serotypes in children and adolescents aged 9 to 16 years at the time of~     inclusion.~      Secondary Objectives:~      To describe the occurrence of serious adverse events (SAEs), including SAEs of special~     interest in all subjects throughout the trial period.~      To describe the efficacy of CYD dengue vaccine after each dose in:~        -  Preventing symptomatic virologically-confirmed dengue cases due to any of the four~          serotypes~        -  Preventing symptomatic dengue cases, either virologically-confirmed or probable based on~          serological criteria, due to any of the four serotypes~   "
167388|NCT01374685|"~     Background:~      - Certain genetic mutations are linked to higher rates of cancer. It is important for people~     with these mutations to tell their families about it. This is because others in the family~     may also be at greater risk for developing these cancers. They can also pass these genes to~     their own children. But not much is known about how African Americans tell their family~     members about the results of their genetic testing. The information from this study can be~     used to improve genetic counseling services. These services will then be more effective in~     early cancer detection and prevention in the African American community.~      Objectives:~      - To learn more about how African Americans who have tested positive for BRCA1/2 mutations~     tell their families about their genetic risk.~      Eligibility:~      - African American (or of African descent) women who recently received positive test results~     for BRCA1/2 mutations.~      Design:~        -  Participants will be screened with a basic medical history.~        -  They will be asked general questions about their personal and family history. These~          include questions on marital and health insurance status, education, and income.~        -  Those in the study will have a 45- to 60-minute phone interview. They will answer~          questions about how they told their family members about their genetic test results.~          They will also be asked what that experience was like.~   "
167389|NCT01374672|"~     This research study is studying biomarkers in predicting response to chemotherapy in samples~     from young patients with osteosarcoma. Studying samples of tumor tissue from patients with~     cancer in the laboratory may help doctors learn more about changes that occur in DNA and~     identify biomarkers related to cancer. It may also help doctors predict how patients will~     respond to treatment.~   "
167390|NCT01374659|"~     Several studies have indicated that [124I]-PET/CT or [18F]-FDG-PET/CT may be useful to locate~     recurrent differentiated thyroid carcinoma lesions in patients with elevated thyroglobulin~     levels but who do not show pathological lesions when conventional imaging modalities are~     used. Thus, the investigators evaluated the effectiveness of PET/CT using both [124I] and~     [18F]-FDG in such patients.~   "
167391|NCT01374646|"~     This study will evaluate the effectiveness of a comprehensive community based program on~     reducing excess weight in children and teens. This study will recruit 150 participants~     between the ages of 6-12 and 13-17.~   "
167392|NCT01374633|"~     Main purpose of the study is to evaluate the effect of sevoflurane on intra cranial pressure~     (ICP) after traumatic brain injury. Patients admitted for traumatic brain injury equipped~     with ICP measurement will be sedated with sevoflurane via the Anaconda device during 12~     hours. Sedation will be controlled with BIS.~   "
167393|NCT01374620|"~     The aim of the study is to determine the MTD of Paclitaxel in association with metronomic~     Cyclophosphamide.~   "
167394|NCT01374607|"~     It is crucial to rapidly identify cardiac ischemia in the care of patients with suspected~     acute coronary syndrome (ACS). Cardiac troponins are a major factor in the diagnostic of~     myocardial infarction. New methods have been developed to improve the accuracy of the assay~     and determine low troponin concentrations. Elecsys® (highly sensible T troponin) TnT-HS assay~     is supposed to help early detection of myocardial infarction after onset of symptoms. It~     should therefore shorten the transit time to emergencies by a more rapid intervention or a~     faster return home. The aim of the study is to compare TnT-HS assay to the standard troponin~     assay in the detection of early cardiac ischemia in patients with ACS.~   "
167395|NCT01374594|"~     PURPOSE~      The goal of the present project is to unravel the importance of bile acid-induced GLP-1~     secretion (via the G protein-coupled receptor TGR5) in human physiology.~      In the present study the investigators examine the GLP-1 secretion in healthy subjects and in~     Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with~     T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and,~     consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1~     responses (primary endpoint).~   "
167396|NCT01374581|"~     This is a bi-centric phase IIIb, randomized, open label, 3-arm clinical trial performed to~     investigate the impact of retreatment with an Artemisinin-Based Combination (ACT), for~     example Arthemeter-Lumefantrine (AL) in Uganda (Ug) and artesunate-amodiaquine (ASAQ) in~     RDCongo, on malaria incidence and its potential selection of resistant strains.~      Patients will be followed-up for efficacy and safety during 42 days after treatment with the~     first line therapy recommended by the national authorities(arthemeter-lumefantrine in Uganda~     and artesunate-amodiaquine in RDCongo) and retreated the patients either with the same ACT or~     an other ACT or oral Quinine + clyndamicin.~      The investigators hypothesize that (re)treatment with the first line ACT treatment beyond 14~     days is as efficacious as any other rescue treatment, without the risk of selecting drug~     resistant strains.~   "
167397|NCT01374568|"~     The purpose of this study is to determine if the use of sitagliptin increases bone formation~     and reduces bone turnover in postmenopausal women with type 2 diabetes.~   "
167398|NCT01374555|"~     The study is designed to evaluate the predictive accuracy of the CardioSond digital~     electronic stethoscope in the detection of coronary artery disease (CAD) in patients with and~     without known disease who are referred to cardiac computed tomography angiography (CT scans).~   "
167399|NCT01374542|"~     Background: Respiratory endoscopy comprises flexible bronchoscopy and medical thoracoscopy.~     The diagnostic yield, technical factors and complications for all patient sub-populations is~     still not clearly defined. This may result in inappropriate or even dangerous application of~     such procedures. The aim of the study is to collect data on these aspects of respiratory~     endoscopy and identify important trends, as well as, areas for improvement. This data will~     also provide baseline comparative data for new bronchoscopic techniques such as endobronchial~     ultrasound and navigational bronchoscopy.~      Method: Prospective data collection. Technical details regarding these procedures are~     currently keyed into the OTM system by the endoscopy operators for documentation and billing.~     The department of Respiratory and Critical Care Medicine gets monthly downloads of all the~     fields from the OTM system for audit purposes.(See data collection form) The research project~     proposes to make the data non identifiable by removing the patient's name and IC number.~     Additionally the yield of the procedure will be checked by a chart review of the histology~     and microbiology results. There are no restrictions on patient recruitment because all~     procedures will be performed for clinical indications only and no patient will be recruited~     for the sole purpose of the study. Waiver of consent has been approved by the IRB.~   "
167404|NCT01374464|"~     Shoulder surgery is known to be extremely painful requiring high doses of opiate analgesics~     (morphine) to control pain. Morphine has numerous unwanted side effects including sedation,~     hallucinations and vomiting.~      It is now standard procedure for patients undergoing shoulder surgery to have their pain~     controlled by means of an injection made around the nerves where they pass through the neck~     to supply the shoulder with sensation (similar to the numbing injections made by the dentist~     before a dental procedure). This injection is called a 'nerve block'.~      Nerve blocks provide complete analgesia after shoulder surgery allowing clinicians to~     discharge patients home on the day of surgery, pain free and with no opiate side effects.~     However, a side effect of nerve blocks at this level is involvement of the phrenic nerve,~     which is anatomically close to the injection point. This may cause (temporary) paralysis of~     the diaphragm and in some cases, severe respiratory dysfunction.~      Research shows that reducing either the volume or the concentration of the drug injected, can~     reduce the consequent respiratory dysfunction. However no study has compared both volume and~     concentration in parallel, to see which of these has the more significant effect in reducing~     respiratory dysfunction. Furthermore there has been no assessment of how these changes may~     affect the duration of analgesia received and patient coping after discharge.~      The investigators propose to conduct a double blind randomised controlled trial at the Royal~     Surrey County Hospital, enrolling patients presenting for elective day case arthroscopic (key~     hole) surgery over a period of 6 months. Patients will receive one of four treatment~     allocations:~        1. Low concentration-high volume of local anaesthetic~        2. Low concentration-low volume of local anaesthetic~        3. High concentration-high volume of local anaesthetic~        4. High concentration-low volume of anaesthetic drug of local anaesthetic.~      The aim of this study is to inform an optimum dosing regimen for patients in order to~     facilitate maximal pain relief and quality of recovery with minimum respiratory dysfunction.~   "
167405|NCT01374451|"~     This study will estimate the treatment effect of everolimus in combination with pasireotide~     LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced~     progressive PNET.~      A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet~     its primary objective, which was based on progression-free survival (PFS) as per local~     radiology assessment and was prematurely terminated with the last patient last visit on~     19-Feb-2015. However, it is important to note that the data did not reveal any new safety~     concerns. It was decided to stop the study and this decision was shared with the study sites~     on 31-Jul-2014.~   "
167406|NCT01374438|"~     This study will evaluate the effect of 150 mg MSDC-0160 taken daily for 90 days compared to~     the effect of placebo on changes in brain glucose utilization using FDG-PET and cognition in~     older persons with mild Alzheimer's disease. Safety and tolerability of MSDC-0160 in this~     population will also be studied. These results will be used to design larger studies of~     MSDC-0160 in persons with mild Alzheimer's disease.~   "
167407|NCT01374425|"~     This will be a randomized, open-label, multicenter, Phase II study with primary objectives to~     assess whether expression of select chemotherapy markers is associated with progression-free~     survival (PFS) in participants treated with bevacizumab plus leucovorin, 5-fluorouracil, and~     oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan~     (FOLFIRI). The study population will consist of participants with first-line mCRC.~   "
167408|NCT01374412|"~     Subject of the proposed study is the non-invasive in vivo imaging of bone, bone marrow and~     localized microcirculation in test animals with osteoporosis, fractures and after placement~     of bone substitute material with volume computed tomography (VCT) (animals only) and~     functional magnetic resonance imaging (MRI). Furthermore patients with multiple myeloma (MM)~     will be examined before and after placement of a commercially available bone substitute~     material. Osseous structures before intervention and structural changes of the bone~     especially at the junction of substitute material and residual bone will be documented. At~     this, the proposed techniques allow imaging of the dynamic healing processes in the living~     organism.~      As next step patients with asymptomatic MM will be investigated with functional Imaging~     longitudinally to predict the occurence of osteolyses at time of Progression.~      Hypothesis: Affection of microcirculation at the junction of bone and bone substitute~     material can be displayed by VCT and functional MRI~   "
167409|NCT01374399|"~     The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an~     one-year physical exercise intervention on prognosis, side-effects and complications after~     allogeneic stem cell transplantation.~      The exercise intervention includes both, resistance and endurance training. Patients assigned~     to the control group perform a relaxation program (progressive muscle relaxation - Jacobsen)~     and have the same frequency of social contact.~   "
167410|NCT01374386|"~     The purpose of this study is to gather information on how much exercising with video games~     (ExerGaming) can increase the physical activity among overweight and youth. This study will~     try to see if participating in physical activity and exercising with video games at the same~     time can make overweight children move around more to better their own health. The hypothesis~     is that those in Exergaming arm will physiological changes and increase physical activity.~   "
167411|NCT01374373|"~     The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® )~     administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia~     (hemoglobin < 10g/dl) undergoing palliative care chemotherapy.~   "
167412|NCT01374360|"~     This study is a collection of data to evaluate safety and characterize progression of~     Paroxysmal Nocturnal Hemoglobinuria (PNH).~   "
167413|NCT01374347|"~     The study will be an open label one and will include 30 patients who underwent ischemic~     stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain~     SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a second~     brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor~     matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study~     will be performed 24 hours after the last dose.~   "
167414|NCT01374334|"~     Aging is associated with loss of muscle strength and a serious import of physical disability.~     Treatment of age-related physical disability should focus on the prevention of the condition~     rather than the consequences. Need to modify daily tasks is an early sign of future mobility~     disability. Many older adults who utilize daily task modifications report no mobility~     difficulty. Neglect to self-report task modification may delay intervention. Identifying~     objective marker of task modification will help to identify task modifiers.~   "
167415|NCT01374321|"~     Objectives of the phase 2 prospective, multicenter, randomized, double-blind,~     placebo-controlled study is to assess safety and efficacy of TRO40303 administered just~     before balloon inflation during percutaneous coronary intervention (PCI) for limitation of~     infarct size in patients treated for acute myocardial infarction (AMI).~      The study is being conducted in 9 centres in Sweden, Denmark, Norway and France. One hundred~     eighty patients will be included. It will last one month per patient and its overall duration~     will be 11 months.~      The efficacy will be assessed by infarct size expressed as area under the curve for creatine~     kinase and troponin I (blood sampling at D1, D2 and D3), and also evaluated by Cardiac~     Magnetic Resonance.~      Safety will be assessed by~        -  clinic evaluation,~        -  blood samples (hematology, biochemistry, renal and hepatic function),~        -  Recording and follow-up of major adverse events occurring during the first 48h after~          reperfusion (death, heart failure, AMI, stroke, recurrent ischemia, the need for repeat~          revascularization, renal or hepatic, vascular complication and bleeding).~        -  ECG~        -  Recording cardiac events during one month after AMI~        -  Follow-up of global left ventricular function by Echocardiography at D3 and D30.~      Demographic and medical history at inclusion and non-cardiac events occurring during the~     first 30 days will be recorded. TRO40303 plasma concentration will be assessed at 15 min, 6h,~     and 12h post the end of administration.~      Sample size calculation assuming a reduction of 35% of the AUC for Troponin I release, for a~     statistical power of 85% and a probability of type I error of 0.05.~      Main analysis: between-group comparisons of AUCs for serum troponin I and CK release will be~     performed using O'Brien's method for multiple endpoints testing.~      Secondary analysis: comparisons of the CMR criteria described above will be performed using~     mixed model of ANCOVA.~      All analyses will be performed on the Full Analysis Set and Per protocol populations.~      Safety analysis: A comparison of the incidence of cumulative adverse clinical events between~     the groups will be performed by Fisher's exact tests.~      Subjects will undergo primary PCI and receive concomitant medications according to current~     standard of care.~      After coronary angiography is performed but just before balloon inflation is performed,~     patients who meet the enrollment criteria will be randomly assigned to either the control~     group or the TRO40303 group. Randomization is ensured by taking the treatment units in~     ascending and consecutive order in each strata (anterior/posterior as determined on ECG).~     Just before balloon inflation, ideally less than 5 minutes, and with a maximum of 15 minutes~     before balloon inflation and stenting, the patients in the TRO40303 group will receive an~     intravenous slow-bolus (35 mL/min) injection of 6 mg/kg of TRO40303 injected in peripheral~     IV. The patients in the control group will receive an equivalent volume of the placebo.~     Patients will be hospitalized for as long as there is a medical indication. CMR and~     echocardiography will accordingly be conducted as in/out patient between day 3 (ideally) and~     5. A follow-up visit will be conducted one month after PCI.~   "
167416|NCT01374308|"~     The general objective of the present clinical trial is to compare the therapeutic efficacy of~     a combination therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and~     hepatitis B core antigen (HBcAg) [later called NASVAC] with a commonly used antiviral drug,~     pegylated interferon in patients with chronic hepatitis B (CHB).~   "
167435|NCT01374048|"~     Patients are subjected to simultaneous intracranial and lumbar puncture pressure~     measurements. This study focus on intracranial pulse amplitude. Hypothesis: Intracranial~     pressure amplitude is reflected by lumbar puncture pressure amplitude.~   "
167420|NCT01374256|"~     Infections caused by imipenem-resistant Acinetobacter baumannii are associated with high~     mortality and morbidity. The treatment choices for this resistant pathogen are limited.~      The objective of the present proposal is to evaluate the effectiveness of combination therapy~     of imipenem and sulbactam in patients contracted with A. baumannii, and to correlate the~     clinical effect with the in vitro synergistic results.~   "
167421|NCT01374230|"~     This study has been designed to document the long-term outcome of the E1® Tibial Bearings~     used with the Vanguard® Knee System in 50 patients receiving total knee arthroplasty. All~     patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic~     analysis and patient reported outcomes will be used as follow-up measures to track wear,~     mechanical performance, and patient satisfaction.~   "
167422|NCT01374217|"~     The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in~     combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.~   "
167423|NCT01374204|"~     Few data about epilepsy-associated stigma in France are available. The only study we have~     found showed that in France 66% of people with epilepsy felt stigmatized by their condition~     and are often single, compared with the other European patients interviewed (Baker et al.,~     2000). The purpose of this study is to assess the association between type of epilepsy (drug~     resistant-epilepsy and stabilized epilepsy) and perceived stigma (using the Stigma Scale) in~     patients recruited in the Limousin region .~   "
167424|NCT01374191|"~     The purpose of this study is to determine if botulinum toxin type A (Btx-A) is an effective~     treatment for painful neuromas. The ideal therapy for painful neuromas would be effective,~     non-addictive, safe, localized, and cost-effective treatment. At the same time, the therapy~     would also address the complex peripheral and central mechanisms. Btx-A is a potential~     treatment that addresses each of these requirements while preserving the existing sensation~     and function.~      Study Hypothesis: Btx-A injection relieves neuroma pain better than a placebo~   "
167425|NCT01374178|"~     The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of~     LY2963016 compared to those of basal insulin. The study will also gather information on the~     safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12~     weeks.~   "
167426|NCT01374165|"~     Prolong proposes to test safety, tolerability and pharmacokinetics of SANGUINATE™ in sickle~     cell disease (SCD) patients. Prolong's preclinical studies showed that SANGUINATE™ was safe~     in a number of different animal models and toxicology studies. In this Phase I trial, Prolong~     will test whether it is also safe and tolerable in sickle cell patients. The study will be~     conducted in 15 adult (>18 years) patients.~   "
167427|NCT01374152|"~     The cognitive sensory motor training therapy (Perfetti's technique) might be more~     effectiveness than conventional occupational therapy on upper extremity function recovery~     after acute stroke patients.~   "
167428|NCT01374139|"~     The purpose of this study is to demonstrate the bioequivalence of the clinical tablet~     formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects~     under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the~     pharmacokinetics of bosutinib after administration of the proposed commercial tablet~     formulation (100 mg x 4) in healthy subjects (Cohort 2).~   "
167429|NCT01374126|"~     A randomized controlled trial to assess the safety and efficacy of azithromycin combination~     therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated~     malaria patients in southeastern Bangladesh.~   "
167430|NCT01374113|"~     The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the~     compound in the body) of safinamide in subjects with different degrees of renal impairment in~     comparison to matched subjects with normal renal function.~   "
167431|NCT01374100|"~     Cancer patients face a number of symptoms related to treatment or disease which may impair~     quality of life, such as decreased functional capacity, fatigue, nausea an vomiting,~     distress, depression and unmet psychological needs. Due to this array of symptoms, cancer~     patients often seek supportive complementary and alternative medicine, which many patients~     use along with conventional treatments. Qigong, a type traditional chinese medicine, is a~     mind-body exercise that combines meditation, slow physical movements, and controlled~     breathing. The investigators hypothesise that Qigong therapy is better in the reduction of~     anxiety and depression levels and the improvement of quality of life in patients with lung~     and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to~     standard exercise training.~   "
167432|NCT01374087|"~     The primary objective of the study was to compare the efficacy of brachytherapy versus~     brachytherapy + triptorelin 22.5 mg (single injection) in subjects with recurrence of~     prostate cancer previously treated with radiotherapy. Efficacy was to be assessed by~     biochemical failure-free survival (BFFS) curves from treatment initiation up to 5 years.~      Secondary objectives included comparing the following: the differences in time to progression~     of subjects receiving brachytherapy + triptorelin 22.5 mg versus subjects receiving~     brachytherapy only, the BFFS percentages between both treatment groups at 5 years from~     treatment initiation, overall survival between both treatment groups, total testosterone~     changes (from baseline visit up to 12 months) and Prostate Specific Antigen (PSA) levels~     (from baseline visit up to 60 months of treatment) between both treatment groups, quality of~     life (QoL) modifications (Spanish version of the Expanded Prostate Cancer Index Composite~     (EPIC) questionnaire) between the baseline score and the rest of measurements, and to compare~     safety between both treatment groups.~   "
167433|NCT01374074|"~     The goal of the proposed research is to investigate the molecular mechanisms of racial~     disparity in Barrett's esophagus (BE), the premalignant lesion of esophageal adenocarcinoma.~     Specifically, the investigators hypothesize that environmental factors, genetic factors, and~     potentially gene environment interactions play crucial roles in the observed racial disparity~     in developing Barrett's esophagus.~      Patients are recruited through UNC hospitals prior to scheduled esophagogastroduodenoscopy~     (EGD). Participants complete a questionnaire, have body measurements obtained, and have~     blood, biopsies, and gastric aspirate collected. Participants also complete a 24 hour pH~     impedance test.~   "
167434|NCT01374061|"~     The objective of this work is to compare standard intubation with video laryngoscope (Glide~     scope Ranger ) in French pre hospital multicentric study.~   "
167436|NCT01374035|"~     The main object to this trial is to study the function of referral letters as a mean to~     coordinate the care process for adult people when referred from Primary Care to Specialised~     Mental Health Care. The study will explore if and to what degree the quality of these~     referral letters can be improved, and the potential improvement's impact on defined patient-,~     professional and organisational related outcomes. According to Medical Research Council~     guidelines for evaluating complex interventions, a stepwise design with the use of both~     qualitative and quantitative methods will be used to conduct a controlled intervention study.~   "
167437|NCT01374022|"~     Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit.~     Discussions about it is exponentially growing up due its high mortality rates all over the~     world and low quality of life among survivors. Mechanical ventilation is recognized to play~     an important role in treatment of patients with ARDS. However, mechanical ventilation itself~     has the potential to produce or worsen alveolar injury if inadequate strategies are chosen.~     Several studies compared different mechanical ventilation strategies in ARDS but the results~     remain uncertain regarding their influence on survival in patients with ARDS. Thus, this is a~     multicentric randomized controlled trial, with allocation concealment and intention to treat~     analysis to investigate if maximum alveolar recruitment maneuver in association to Positive~     end-expiratory pressure (PEEP) titrated by static compliance of respiratory system (ART~     strategy) is able to increase 28 days survival in patients with moderate to severe ARDS~     compared to conventional strategy proposed by the ARDS Clinical Network (ARDSNet strategy).~     Patients considered to this trial are those in mechanical ventilation with diagnosis of~     moderate to severe ARDS less than 72hours. Patients included will be randomized to receive~     ART strategy or ARDSNet strategy and will be followed until hospital discharge, 28 days and 6~     months.~   "
167438|NCT01374009|"~     The goal of this study it to rapidly create a brief registry of pregnant women who receive~     the H1N1 vaccine in Ontario, British Columbia, and Nova Scotia during the pandemic H1N1~     2009/2010 influenza season.~   "
167439|NCT01373996|"~     The purpose of this study is to determine whether wireless transmission of invasive arterial~     blood pressure signal (by HMW 10 Wireless System) from patient to patient's bedside monitor~     is feasible, safe and as accurate as conventional cable connection.~   "
167440|NCT01373983|"~     The purpose of this study is to evaluate if the effect of ziconotide can be tested by~     intrathecal bolus doses.~   "
167441|NCT01373970|"~     Proton pump inhibitors (PPI) have been shown to cause acid reflux related symptoms at~     withdrawal in healthy volunteers, a phenomenon known as Rebound Acid Hyper Secretion. Whether~     this also applies for patients with dyspeptic symptoms but without true reflux disease~     (functional dyspepsia) treated with PPI is unknown. If this is the case, it could lead to an~     unfortunate long term use of PPI, since the acid rebound renders withdrawal too difficult.~      This is a single centre, randomized, double-blinded, placebo-controlled cross over study.~     Study period is 12 weeks per study subject. Study subjects are referred to the study from~     General Practitioner (GP) and the gastroenterology department or endoscopy clinic of the~     investigational centre.~      The study population consists of patients who seek their GP because of dyspepsia without~     alert signs, and whom the GP may consider starting on PPI. Out patients referred to the~     gastroenterology department or endoscopy clinic of the investigational centre because of~     dyspepsia without specific exclusion criteria are also invited to participate.~      Baseline interview, upper endoscopy and pH monitoring are performed one week before inclusion~     to exclude patients with GERD. Helicobacter Pylori (Hp.) status is assessed by Helicobacter~     Urease Test (HUT). Hp. positive subjects without ulcus are not excluded.~      Patients with a positive pH monitoring will not be included in the analysis regarding the~     primary endpoint (Development of GERD) but will be included in the analysis regarding one of~     the secondary endpoints (Effect of PPI on Functional Dyspepsia).~      Study subjects are randomized to either pantoprazol followed by cross over to placebo or to~     placebo. Escape medication in the form of Gaviscon can be used on demand.~      Internet based questionnaires are answered weekly. Questionnaires consist of the~     Gastrointestinal Symptom rating Scale (GSRS) in combination with items assessing postprandial~     fullness and items assessing the Montreal Criteria for Gastro Esophageal Reflux Disease~     (GERD).~      Compliance to protocol is assessed at hospital visits every fourth week. At the end of study~     endoscopy and pH monitoring are repeated.~   "
167442|NCT01373957|"~     EPICOR-RUS is a multi-centre, observational, prospective, longitudinal cohort study which~     will include patients, in a real-life setting, who are hospitalized for acute coronary~     syndrome (ACS) within 24 hours of symptom onset and who have a final diagnosis of Unstable~     Angina (UA), ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial~     Infarction (NSTEMI). Patients will undergo clinical assessments and receive the standard~     medical care as determined by the treating cardiologist. Patients will not receive~     experimental intervention or experimental treatment as a consequence of their participation~     in the EPICOR-RUS observational study.~   "
167443|NCT01373944|"~     The purpose of this study is to compare clinical efficiency and patient outcomes using ultra~     low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.~   "
167444|NCT01373931|"~     This study involves a single dose of 18 mg LY2216684 taken as 1 or 2 tablets by mouth. The~     study will evaluate effect of LY2216684 on the pharmacokinetics of an oral contraceptive~     Ortho Cyclen®. This study will run approximately 93 days.~   "
167445|NCT01373918|"~     Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral~     Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to~     prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of~     standard intravenous fat emulsions have implicated in the development and progression of~     PNAC.~      In this study, neonates with congenital/acquired gastrointestinal disorders will be~     randomized, in a unblinded fashion, to receive either the standard dose of an intravenous~     omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion~     throughout their course of PN or until hospital discharge, death or 100 days of life,~     whichever comes first. The primary outcome will be the presence of cholestasis.~   "
167446|NCT01373905|"~     Acute respiratory distress syndrome is a severe lung disease caused by a variety of direct~     and indirect issues. It is characterized by inflammation of the lung parenchyma leading to~     impaired gas exchange and persistent hypoxemia. This condition is often fatal, usually~     requiring mechanical ventilation. Recruitment maneuver aimed to enhance the effect of~     mechanical ventilation.The objective of this study was to compare safety and efficacy of two~     lung recruitment maneuvers.~   "
167461|NCT01373697|"~     The aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety~     treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or~     myofascial compared to Profenid 25mg/g gel.~   "
167462|NCT01373684|"~     This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative~     chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the~     degree of HBsAg decline.~   "
167447|NCT01373892|"~     The objectives of this study are to measure effect of obesity on brain structure and~     molecular pathways, food-stimuli mediated brain activation response, on hormones affecting~     both feeding and energy balance as well as on bone metabolism and bone marrow fat. In the~     first phase the studies are performed at baseline before bariatric surgery and in the second~     phase post-operatively after 6 months. Regional free fatty acid uptake are studied with PET~     and 14(R, S)-[18F]-fluoro-6-thia-heptadecanoic acid ([18F]FTHA). Changes in body fat~     distribution are investigated with magnetic resonance imaging (MRI) Brain reward system~     response to food stimuli is assessed using functional MRI (fMRI) and white and grey matter~     volumes using diffusion tensor imaging (DTI). Brain neurotransmitter system will be measured~     with [11C]raclopride and [11C]carfentanil and PET. In the second part of the study the same~     variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or~     Roux-en-Y gastric bypass.~   "
167448|NCT01373879|"~     The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and~     AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria~     endemic region. The regimen proposed here has protected non-immune volunteers in Oxford~     against sporozoite challenge, and so may be protective against naturally acquired infection~     in The Gambia.~   "
167449|NCT01373866|"~     -  The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from~          drug-resistant multisensory hallucinations will be tested by the implementation of a~          double-blind randomized controlled trial (RCT)~        -  This study will use a combination of different MRI modalities (fMRI and DTI) to define~          with precision rTMS brain-targets in the case of multisensory hallucinations~        -  The investigators anticipate that multimodal MRI-guided rTMS will allow a significant~          improvement in the efficacy of neuromodulation treatment of refractory hallucinations~   "
167450|NCT01373853|"~     This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye~     study to determine the safety and efficacy of intraocular cuts for femtosecond laser assisted~     lens frag-mentation to support phacoemulsification of the cataractous lens prior to IOL~     implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with the~     CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and~     height dependent on anterior chamber depth, pupil diameter and ocular lens size.~      The hypothesis of the study is that by means of femtosecond laser assisted lens fragmentation~     the required ultrasound energy used for phacoemulsification can be reduced in a safe and~     effective way.~   "
167451|NCT01373840|"~     Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained~     muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in~     the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather~     rudimentary. A better understanding of neural mechanisms of dystonias is not only an~     invaluable prerequisite for developing better treatment options but also a step toward better~     understanding of the complex network of basal ganglia. In this study I will investigate if~     there is any difference between the dopamine receptors and dopamine in people with dystonia~     and healthy subjects.~   "
167452|NCT01373827|"~     Patients enrolled in this study will come from the Investigator's patient population and be~     ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no~     different if they participate than if they do not. The study is only to observe the patients~     before, during and after their usual treatment.~   "
167453|NCT01373814|"~     The goal of this study is to determine if nutritional therapy can effectively treat/prevent~     T2DM and its consequent cardiomyopathy.~   "
167454|NCT01373801|"~     The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR~     compared to standard bandaging in subjects with post partum hemorrhage as a result of~     cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30~     minutes after insertion of the dressing.~   "
167455|NCT01373775|"~     To identify the risk factors of the revisit of the adult HF patients in emergency department.~   "
167456|NCT01373762|"~     The purpose of this study is to determine whether an interactive exercise videogame bike is~     effective in improving physical activity adherence, motivations to do physical activity, and~     physical fitness among families. Families receive either an interactive videogame bike and~     gaming console, or a traditional stationary bike which is placed in front of the television,~     to keep in their home for six months. It is expected that families within the videogame bike~     condition will show greater exercise adherence. It is also expected that these families will~     have higher self-reported physical activity levels, greater motivation to do physical~     activity, and improved cardiovascular fitness at the end of the three month period compared~     to the families in the stationary bike condition.~   "
167457|NCT01373749|"~     Nitro Oxide (NO) inhalation was recognized as an effect treatment of Neonatal Persistent~     Pulmonary Hypertension (PPHN), while the safety of NO long term application was under~     investigation. Several research suggested too much NO2 was generated in the lung after long~     term (> 72h) use of NO inhalation, which cause bad effects on PS production.~      Sildenafil was proved to be effective to PPHN as NO. This medication has a similar clinical~     effect but need monitoring of blood pressure. The possible hypotension effect restrict the~     dosage of sildenafil, which limit the usage of sildenafil in severe PPHN. But we recommend~     sildenafil to The purpose of the study was to establish if NO continued with sildenafil has~     the same effect as single NO inhalation.~   "
167458|NCT01373736|"~     The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic~     imaging agent in evaluating patients with known or suspected neuroendocrine tumors.~   "
167459|NCT01373723|"~     The aim of this study was to compare the effectiveness and the costs of three types of~     population interventions to increase the number of female participants in the screening~     programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care~     Areas.~   "
167460|NCT01373710|"~     The purpose of this study is:~      Phase I: To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated~     by intrathecal or intraventricular route to reach a intra CSF target concentration (30 µg/mL)~     near the conventional therapeutic concentration and depending on the dose-limiting toxicity~     (DLT)~      Phase II: Determination of antitumor activity trastuzumab when administrated by IT or~     intra-ventricular in terms of neurological progression-free survival at 2 months~   "
167463|NCT01373671|"~     The primary objective of this protocol is to collect the 2-dimensional (2D) screening and~     diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from~     patient mammography examinations acquired on various commercially available Full Field~     Digital Mammography (FFDM) systems and the Siemens Inspiration DBT system, respectively.~   "
167464|NCT01373658|"~     Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and~     delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from~     a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may~     prevent these complications.~   "
167465|NCT01373645|"~     Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and~     delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from~     a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may~     prevent these complications.~   "
167466|NCT01373632|"~     Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating~     patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW~     Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical~     trials. Here the investigators design a prospective, multicenter, randomized clinical study~     in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD~     patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel~     SES.~   "
167467|NCT01373619|"~     Heart failure with normal ejection fraction is often under diagnosed and certainly under~     treated in hemodialyzed patients. Because of the benefit of reducing heart rate, ivabradine,~     a pure heart-rate lowering agent without effects on blood pressure, is of potential~     therapeutic utility.~   "
167468|NCT01373606|"~     This is an open-label, multi-center study, investigating the efficacy and safety of~     terlipressin in Japanese patients with hepatorenal syndrome type 1.~   "
167469|NCT01373593|"~     In this controlled study the investigators will examine the analgesic and sensory effects of~     ultrasound-guided blocks of the iliohypogastric and ilioinguinal nerves with lidocaine in~     persistent postherniorrhaphy pain patients.~   "
167470|NCT01373580|"~     This study will be a prospective, multicenter clinical trial in which a total of 400 subjects~     will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of~     15 clinical sites participating. Qualified subjects will provide informed consent for entry~     into the study.~   "
167471|NCT01373567|"~     Psoriasis is a chronic inflammatory hyperproliferative disease of the skin affecting~     approximately 2% of the world's population.This phase IV study is planned to monitor~     performance of Tinefcon in patients suffering from psoriasis under conditions of actual use~     and fulfill requirements to monitor all adverse drug reactions (ADRs) in psoriasis patients~     treated with Tinefcon. This study will add to literature on the risks and benefits of~     Tinefcon the novel oral TNF-alpha release inhibitor.~   "
167472|NCT01373554|"~     Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK)~     activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1~     (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the~     development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some~     research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in~     SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of~     lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c.~     Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c~     pathway in liver.~   "
167473|NCT01373541|"~     The purpose of this study is to determine the effect of infant formula with high percentage~     of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general~     gastrointestinal tolerance in Chinese formula-fed term infants.~   "
167474|NCT01373528|"~     Chronic rhinosinusitis (CRS) is a complex inflammatory disease that is treated primarily with~     sinus surgery and the long-term use of topical steroid therapy. Budesonide irrigation is a~     common method of topical steroid treatment for these patients. However, the effects of~     budesonide irrigation on the hypothalamic-pituitary-adrenal (HPA) axis in patients with CRS~     following sinus surgery, is as of yet not defined. The objective of this study is to~     determine if topical sinonasal budesonide steroid irrigation leads to acute recoverable~     and/or long-term suppression of the HPA axis. Participants in this prospective cohort study~     will have CRS and have recently undergone endoscopic sinus surgery. They will also have had~     planned use of budesonide irrigations as their postoperative medical treatment. The acute~     effects of this treatment on the HPA axis will be evaluated using serial serum cortisol~     measurements both the day before and the day of the first budesonide irrigation. The~     long-term effect of sinonasal budesonide irrigation will be evaluated using both a pre- and~     post-treatment adrenocorticotropic hormone (ACTH) stimulation test as well as repeated urine~     free cortisol levels over the length of the study. The results will determine the need for~     additional steroids when patients stop treatment or with a physiologic stressful event.~   "
167475|NCT01373515|"~     This is an open label phase 1 feasibility and safety dose escalation study. The main~     objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML.~   "
167476|NCT01373502|"~     The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy~     of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic~     lesions in native coronary arteries.~   "
167477|NCT01373489|"~     The purpose of this study is to help low income patients achieve and maintain better~     self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood~     pressure monitoring system and nurse case management. Patients must be served at a Federally~     Qualified Health Center (FQHC) in coastal South Carolina.~   "
167478|NCT01373476|"~     Objectives of study: To preliminarily evaluate the efficacy and safety of Qideng Mingmu~     Capsule in the treatment of patients with diabetic retinopathy (deficiency of Qi-Yin~     syndrome, blood stasis syndrome), to discuss the appropriate dose and period of treatment.~   "
167704|NCT01370499|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     LY2216684 administered once daily in the adjunctive treatment with an Selective Serotonin~     Reuptake Inhibitors (SSRI) for up to approximately 1 year in patients with Major Depressive~     Disorder (MDD) who were partial responders to their SSRI treatment.~   "
167479|NCT01373463|"~     This study is open to patients that have been diagnosed with non-squamous Stage III Non Small~     Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor.~      The purpose of this study is to:~        -  Test a combination of two chemotherapeutic drugs along with radiation therapy, when~          given prior to surgery and see what effects (good or bad) it has on someone with this~          type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and~          tissues.~        -  Test the safety of different dose levels of radiation when given with each combination~          of chemotherapy;~        -  Determine what side effects are associated with combining radiation with these two~          chemotherapy combinations.~   "
167480|NCT01373450|"~     This was a four-period crossover study to assess the glycemic effects of a single dose of~     oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus~     (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4~     treatment periods, with a 7-day wash-out between each treatment period. The primary~     hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or~     better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly~     enhancing insulin secretion.~   "
167481|NCT01373437|"~     The purpose of this study is to assess the applicability of using ultrasonography in~     confirmation of the position of the endotracheal tube (ETT) after intubated to patients.~   "
167482|NCT01373424|"~     Dystonia is a disorder characterized by excessive involuntary contraction of muscles with~     repetitive and patterned movements. The isolated dystonias are the most common type of~     dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic~     torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias~     (like blepharospasm). The purpose of this study is to create resources to help learn more~     about the isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to develop~     and validate various dystonia rating scales.~   "
167483|NCT01373411|"~     Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and~     randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48~     hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which~     time they will receive telephone follow-up one and nine months following CABG and clinic~     visits three, six, and twelve months following CABG.~   "
167484|NCT01373398|"~     The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical~     instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).~   "
167485|NCT01373385|"~     The purpose of this research is to provide a clearer understanding of quality and outcomes~     for three types of surgical procedures performed at Connecticut Children's for treatment of~     vesicoureteral reflux. In order to consistently gather data over time, the investigators~     propose to establish database for surgical intervention for vesicoureteral reflux.~      Specific Aim 1: To consistently collect performance and outcomes data for the surgical~     treatment of vesicoureteral reflux in order to increase internal understanding of these~     procedures.~      Specific Aim2: To consistently collect performance and outcomes data for the surgical~     treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for~     publication.~   "
167486|NCT01373372|"~     Chronic abdominal pain is the most common persistent pain condition in children and~     adolescents, affecting 10-15% of children at any given time. One of the most often diagnosed~     types of abdominal pain is functional dyspepsia (FD). FD is an abdominal pain or discomfort~     (e.g., nausea, bloating) in the upper abdomen that does not get better by going to the~     bathroom.~      For some people it appears that stress can make FD worse. In adults, stress can cause the~     release of a hormone called corticotropin releasing hormone (CRH). The release of CRH can~     cause abdominal pain by affecting how fast things move through a person's stomach and~     intestines. This makes the organs in the abdomen more sensitive to pain, causing tenderness~     of the inside lining of the stomach and intestines.~      Different people react differently when the body releases CRH. Some people have abdominal~     pain without feeling any stress or anxiety while other people who have a lot of stress or~     anxiety don't have any abdominal pain. Some people have neither stress, anxiety, or abdominal~     pain when CRH is released into the body.~      In order to see how the bodies of children with functional dyspepsia and those without~     functional dyspepsia react to CRH, we will do a CRH stimulation test. A CRH stimulation test~     is routinely done in endocrine patients. It is not routinely done for patients with~     functional dyspepsia or for patients who do not have functional dyspepsia.~      Part of the CRH stimulation test is giving a synthetic type of corticotropin, Acthrel® (brand~     name for Corticorelin), as injection. Acthrel® has been approved by the Food and Drug~     Administration (FDA) for use.~      The purpose of this research study is to see if there are differences in how the bodies of~     children with functional dyspepsia react to CRH versus children who don't have functional~     dyspepsia.~      Being in this study involves one clinic visit where an IV placed and a CRH stimulation test.~     In this test the child will be given an injection of CRH and then observed for one hour.~     During that hour the child will have five blood draws through the IV and will be asked~     questions about their anxiety and abdominal pain. This visit will take about 4 hours.~      The following things will happen:~        -  Your child will be asked to come to the clinic between 8a.m. and 10a.m. fasting. This~          means your child will have had nothing to eat or drink for 8 hours before coming to the~          clinic.~        -  If your child is a female ten years of age or older, or has started having periods, a~          urine pregnancy test will be done before receiving the CRH infusion.~        -  You and your child will each be asked to complete a survey that measures your child's~          anxiety.~        -  Your child will have a biofeedback session that will measure your child's stress. In a~          biofeedback session, sensors are placed on your child's fingers, wrists and forehead.~          These sensors are connected to a computer that monitors your child's heartbeat, skin~          temperature and electrical pulses on your child's skin.~        -  Your child will have an IV inserted into a vein in his/her arm. Your child may have a~          cream put on their arm to help with the pain of the IV insertion. The IV will be used to~          inject the CRH and draw blood. If the IV stops working and blood samples can no longer~          be drawn from it, your child may have another IV started or blood samples may be drawn~          by needle stick.~        -  Your child will then have 30 minutes to relax.~        -  Your child will then have CRH infused through the IV over one minute.~        -  Your child will have blood drawn through the IV five times; right before the CRH~          stimulation test begins and 15, 30, 45 and 60 minutes after the CRH infusion. The total~          amount of blood drawn for the study will be about 2 ½ tablespoons.~        -  Your child will be asked about their abdominal pain, nausea, bloating, stress and~          anxiety at three separate times during the 60 minutes.~        -  Your child's heart rate will be measured throughout the CRH stimulation test.~   "
167487|NCT01373359|"~     Sublingual misoprostol produces rapid peak concentration and is more effective than oral~     misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test~     whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have~     30 ml less average blood loss than women receiving oxytocin, the standard of care for~     prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial~     of .652 consenting, eligible pregnant women admitted to the labor room of the teaching~     hospital at J N Medical College, Belgaum, India. Women participating in the study were~     assigned by computer generated randomization to receive the study medications and placebos~     within one minute after clamping and cutting the umbilical cord. We also looked at the drugs~     effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent~     of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.~   "
167488|NCT01373346|"~     We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric~     cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en~     Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer.~   "
167489|NCT01373333|"~     Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton~     Myasthenic Syndrome (LEMS). 3,4-DAP is used to decrease the muscle weakness associated with~     LEMS and hopefully will decrease the need for prednisone and all other therapies that were~     previously required to control symptoms. How long a patient will take 3,4 DAP depends upon if~     he/she is seeing benefits from the medication or experiencing side effects that will prevent~     them from continuation in the study.~   "
167490|NCT01373320|"~     The study purpose is to evaluate the effectiveness of a set of culturally appropriate,~     faith-placed lay health advisor interventions aimed at facilitating smoking cessation and~     increasing cancer screening among Appalachian participants.~   "
167491|NCT01373307|"~     The study purpose is to evaluate the effectiveness of a culturally appropriate, faith-placed~     lay health advisor intervention aimed at increasing fruit and vegetable intake and physical~     activity among intergenerational Appalachian individuals and families.~   "
167492|NCT01373294|"~     The purposes of this study are to:~        -  find out whether participants' cancer returns or gets worse while they are taking~          lenalidomide and Bacille Calmette-Guerrin (BCG);~        -  evaluate the safety and tolerability of the combination of lenalidomide and BCG;~        -  compare the cancer progression of participants taking lenalidomide and BCG versus~          participants taking only BCG~   "
167531|NCT01372774|"~     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor~     cells. It is not yet known whether stereotactic radiosurgery is more effective than~     whole-brain radiation therapy in treating patients with brain metastases that have been~     removed by surgery.~      PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works~     compared to whole-brain radiation therapy in treating patients with brain metastases that~     have been removed by surgery.~   "
167532|NCT01372761|"~     The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and~     effective.~   "
167493|NCT01373281|"~     The aim of this trial is to assess the efficacy of the CYD dengue vaccine in preventing~     symptomatic, virologically-confirmed dengue cases.~      Primary Objective:~      To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in~     preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due~     to any of the four serotypes in children aged 2 to 14 years at the time of inclusion.~      Secondary Objectives:~      To describe the efficacy of CYD dengue vaccine after each dose in:~        -  Preventing symptomatic virologically-confirmed dengue cases due to any of the four~          serotypes~        -  Preventing symptomatic dengue cases, either virologically-confirmed or probable based on~          serological criteria, due to any of the four serotypes~      To describe the occurrence of serious adverse events (SAEs), including serious adverse events~     of special interest in all subjects throughout the trial period.~   "
167494|NCT01373255|"~     Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted~     into the uterine myometrium. The most significant complication is intense bleeding, mainly~     during labor. The most important risk factors are previous cesarean delivery, placenta~     previa, and advanced maternal age. Cesarean hysterectomy is the recommended management.~     During the recent years, inserting intravascular balloon catheter for occlusion and/or~     arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss~     during cesarean hysterectomy or in conduct with conservative management with the intent of~     avoiding hysterectomy in selective cases. Contradicting reports exist regarding the~     effectiveness and safety of the catheters in cases of placenta accreta. The objective of this~     study is to estimate the efficacy of the balloon catheters among women diagnosed with a~     placenta accreta.~   "
167495|NCT01373242|"~     The goal of this study will be to increase the reaction threshold (desensitization) of peanut~     allergic children using peanut sublingual immunotherapy and to determine if the nonreactive~     state of the immune system persists after treatment has been discontinued (tolerance).~   "
167496|NCT01373229|"~     In research studies, lenalidomide (also called Revlimid) has shown some response in chronic~     lymphocytic leukemia (CLL); however, responses are usually partial responses that occur after~     several months of taking the study drug. It is thought that by adding the drug plerixafor~     (also called Mozobil) responses may be improved and/or occur sooner.~      The main purpose of this study is to determine the dose of plerixafor that is safe to use in~     combination with lenalidomide. The study will also look at the response rates of the~     combination of lenalidomide and plerixafor and the effect the study drugs have on CLL cells.~   "
167497|NCT01373216|"~     GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects~     on cardiac function and metabolism in both experimental models and in patients with type 2~     diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and~     glucose control in patients undergoing cardiac surgery are not known. Based on the results of~     experimental studies there is a potential for exenatide to positively influence both cardiac~     function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes~     mellitus. The primary endpoint of this study is to examine whether pre- and peri-operative~     administration of exenatide affects perioperative hemodynamics, echocardiographic parameters,~     necessity of antiarrhythmic and inotropic treatment and glucose control in patients with~     coronary atherosclerosis and decreased left ventricular function undergoing elective coronary~     artery bypass grafting operation (CABG). In addition, safety and tolerability of~     peri-operative administration of exenatide in these patients will be examined as a secondary~     study objective.~   "
167498|NCT01373203|"~     The important character of acute lung injury (ALI) is alveolar capillary membrane damage~     caused by different diseases, such as sepsis, trauma and shock. One of the important~     pathological stages is the varying degrees of interstitial fibrosis and semi-permeable~     alveolar membrane fibrosis. It has been proved that CXCL12/SDF-1 (stromal cell-derived~     factor-1) induces fibrocyte migration, and promotes fibrosis progression. Study indicated~     that inhibition of TLR4 receptor signaling pathway improves fibrosis progression induced by~     ALI, however, the role of fibrocyte in ALI is still unclear. The fibrocytes was significantly~     increased in asthmatic patients with pulmonary fibrosis, which companies with increased CTGF~     expression. Therefore, this project assumes that fibrocyte will differentiation to~     fibroblast/myofibroblast in patient with acute lung injury, which in turn leads to~     progression of fibrosis. The central hypothesis of this project is that peripheral progenitor~     cell fibrocytes play an important role in alveolitis caused by acute lung injury. The overall~     objective of this project is to study the role of fibrocytes in acute lung injury.~   "
167499|NCT01373190|"~     The specific aim is to determine if there are patterns of temperature differences in the~     abdominal and back regions of individuals with partial/focal onset epilepsy as compared to a~     non-epileptic control group. The hypothesis is that individuals with partial/focal onset~     epilepsy will have colder recorded temperatures in the abdominal area than individuals in a~     matched control group.~   "
167500|NCT01373177|"~     The objective of this randomized study is to test the hypothesis that scores on the Bayley~     Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of~     Infant Development-II (BSID-II) in the same group of infants who were born very preterm.~   "
167501|NCT01373164|"~     Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with~     gemcitabine in patients with solid malignancy~      Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable~     pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that~     of gemcitabine plus placebo.~   "
167502|NCT01373151|"~     The purpose of this study is to determine the effective dose of BMS-945429 in subjects with~     inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid~     Arthritis.~   "
167503|NCT01373138|"~     This is an open label randomised, 2-way crossover, comparative bioequivalence study.~   "
167504|NCT01373125|"~     The investigators propose a study comparing the morphological and functional aspects of the~     neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE)~     to that of native squamous epithelium in normal controls as well as gastroesophageal reflux~     disease (GERD), non-Barrett's Esophagus (BE) subjects.~   "
167581|NCT01372124|"~     This is a multi center, open label, parallel group, single administration, phase I trial, in~     subjects with mild, moderate or severe renal impairment and a control group with normal renal~     function.~   "
167505|NCT01373112|"~     Infection remains a difficult-to-treat complication of total knee arthroplasty. The gold~     standard treatment is two-stage removal of the prosthesis with later replacement of permanent~     implants. The first stage consists of removal of the infected arthroplasty components and the~     surrounding devitalized tissue, copious pulsed irrigation, and placement of a temporary~     antibiotic-impregnated cement spacer. This spacer typically is left in place six weeks,~     during which time the patient receives intravenous antibiotics. After the surgeon feels that~     the infection has been eradicated, or if the patient requires repeat debridement, a second~     operative procedure is performed. While the use of an antibiotic-loaded spacer is well~     accepted, whether the spacer should immobilize the knee (a so-called static spacer) or~     allow for range of motion (a so-called articulating spacer) is controversial. Proponents of~     articulating spacers argue that they prevent scarring of the musculature surrounding the knee~     resulting in easier reimplantation, improved long-term knee function, and improved range of~     motion. Proponents of static spacers argue that immobilization of the periarticular soft~     tissues aids in clearance of the infection and is simpler to fashion intraoperatively. While~     good results have been described with both methods, comparative trials have been conflicting~     as to whether spacer design alters knee function, operative time, and range of motion.~     Equipoise exists within the literature, and no randomized clinical trial has been conducted~     to evaluate this issue.~      The purpose of this study is to compare articulating and static antibiotic-impregnated~     spacers for the treatment of chronic periprosthetic infection complicating total knee~     arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to~     determine the effect of spacer design upon eradication of infection, knee function, ease of~     reimplantation, and range of motion. The investigators hypothesize that articulating spacers~     will provide shorter operative times at reimplantation, while improving knee function and~     range of motion.~   "
167506|NCT01373099|"~     Infection remains one of the most difficult-to-treat complications of total hip arthroplasty.~     The gold standard treatment is two-stage removal of the prosthesis with later replacement of~     permanent implants.The first stage consists of removal of the infected arthroplasty~     components and the surrounding devitalized tissue, copious pulsed irrigation, and placement~     of a temporary antibiotic-impregnated cement spacer. This spacer is typically left in place~     six weeks, during which time the patient receives intravenous antibiotics. After the surgeon~     feels that the infection has been eradicated, or if a second debridement is required, a~     second operative procedure is performed. While the use of an antibiotic spacer is well~     accepted, whether the spacer should immobilize the hip (a so-called static spacer) or allow~     for range of motion (a so-called articulating spacer) is controversial. Proponents of~     static spacers argue that immobilization of the periarticular soft tissues aids in clearance~     of the infection and that these spacers are simpler to fashion intraoperatively. Proponents~     of articulating spacers argue that they improve hip function, prevent damage to the~     musculature surrounding the hip, allow easier reimplantation, improve hip function, and~     prevent dislocation following hip reimplantation. While good results have been described with~     both methods, comparative trials have been conflicting as to whether spacer design alters hip~     function, operative time, and dislocation rates. Equipoise exists within the literature, and~     no randomized clinical trial has been conducted to evaluate this issue.~      The purpose of this study is to compare articulating and static antibiotic-impregnated~     spacers for the treatment of chronic periprosthetic infection complicating total hip~     arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to~     determine the effect of spacer design upon eradication of infection, hip function, ease of~     reimplantation, and dislocation rates. The investigators hypothesize that articulating~     spacers will provide shorter operative times at replantation while improving hip function and~     hip dislocation rates following hip reimplantation.~   "
167507|NCT01373086|"~     This study will assess the efficacy and safety of LFF269 compared to placebo after treatment~     in subjects with essential hypertension.~   "
167508|NCT01373073|"~     The purpose of this study is to assess growth of preterm infants fed human milk supplemented~     with an experimental human milk fortifier.~   "
167509|NCT01373060|"~     This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of~     ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.~   "
167510|NCT01373047|"~     The purpose of this study is to collect data on the safety and potential effectiveness of 2nd~     generation designer T cells delivered into the hepatic circulation in patients with liver~     metastases expressing the CEA tumor marker. Designer T cells are prepared by collecting white~     blood cells from the participant, and then modifying these cells in the laboratory so that~     they recognize the tumor antigen, CEA. These modified cells are then given back into the~     participant so that they can attack and kill tumor cells. The investigators hypothesize that~     regional delivery of the designer T cells directly into the hepatic artery will minimize~     systemic toxicity and optimize the changes for therapeutic effect.~   "
167511|NCT01373034|"~     The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea~     predominant irritable bowel syndrome.~   "
167512|NCT01373021|"~     The purpose of this study is to determine whether additional Dexmedetomidine to patient~     controlled analgesia can reduce fentanyl consumption.~   "
167513|NCT01373008|"~     Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly~     treated with inhaled steroids, an optional treatment according to textbooks and guidelines .~     However, the evidence supporting this treatment in spontaneously breathing infants is~     limited, and based on only two randomized, placebo-controlled trials (RCT) with relative~     small number of infants . The Cochrane review concluded that these studies do not allow firm~     conclusions with regard to the efficacy of inhaled steroids in non-ventilated infants . Thus,~     there is no doubt that there is a need for more RCT in order to ascertain the role of inhaled~     steroids in infants with BPD. Because of its physical properties that theoretically make QVAR~     an attractive therapy in infants and studies showing it to be as effective as and with~     similar safety profile as other inhaled steroids in children, the investigators hypothesized~     that inhaled QVAR will be an effective therapy in infants with BPD.~   "
167514|NCT01372995|"~     The increasing rate of hospital-acquired infection and antibiotic resistance are major causes~     of prolonged ICU stay and death in hospitalized patients. The enormous impact of ICU-related~     infection demands the need for cost-effective therapies that can be rapidly implemented to~     improve patient immune response to control infection. Unfortunately, little high-quality~     comparative effectiveness research has been performed on micronutrient treatment regimens as~     methods to decrease hospital-acquired infection in critically ill patients. Critically ill~     medical and surgical patients have an extremely high prevalence of vitamin D insufficiency.~      We will perform a rigorous, double-blind, randomized, controlled, pilot clinical trial in~     ventilator-dependent ICU patients to test the clinical/metabolic safety and efficacy of two~     doses of oral high-dose vitamin D3 therapy versus standard therapy (no supplemental vitamin~     D). The primary endpoint is to test whether high-dose regimens [either 50,000 or 100,000~     international units (IU) of enteral vitamin D3 given daily for 5 consecutive days (total dose~     = 250,000 or 500,000 IU, respectively) increase plasma 25(OH)D concentrations into a~     desirable range (> 30 ng/mL).~   "
167515|NCT01372982|"~     The purpose of this study is to compare bioavailability in healthy, post menopausal women~     subjects under fed conditions.~   "
167516|NCT01372969|"~     The purpose of this study is to asses the safety and efficacy of adipose-derived adult stem~     cells from healthy donnors for treatment of complex perianal fistulas in Crohn's disease.~   "
167517|NCT01372956|"~     This is a multi-centre, cross-sectional, chart review study to investigate cholesterol goal~     attainment rates defined by modified NCEP-ATP III guidelines and define its possible~     determinants among Korean dyslipidemic patients~   "
167518|NCT01372943|"~     CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which~     may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse.~     Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. Stool~     transplant (infusing donor stool into the intestine of the recipient), is not very palatable~     to either patient or medical personnel. The investigators will isolate intestinal bacteria~     from donor stool and use this purified mixture of donor bacteria instead of stool transplant.~     The investigators hypothesize that this cleaner mixture of purely isolated intestinal~     bacteria from a healthy donor would be equally effective as conventional fecal~     bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and~     anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora~     reconstitution. However our approach would provide a more controlled, reproducible, cleaner~     and more aesthetically acceptable method of administration, and from a patient safety~     perspective, would also be a safer strategy than using freshly defecated donor fecal matter.~   "
167519|NCT01372930|"~     Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin~     concentration after myocardial infarction/reperfusion and also beneficial for the patients~     undergoing percutaneous coronary intervention (PCI).~   "
167520|NCT01372917|"~     The study is a prospective multi-centered cohort study designed to determine the safety and~     efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the~     study is designed to determine if sterility of human acellular dermal matrix results in a~     lower incidence of infection and seroma. The study will determine if gamma radiation, as a~     method of terminally sterilizing human acellular dermal matrix, has a negative impact on~     graft incorporation into the host tissue.~   "
167521|NCT01372904|"~     Cisplatin is a widely used chemotherapeutic agent for the treatment of various malignant~     neoplasms, including testicular, ovarian, bladder, cervix uteri, head and neck and lung~     cancers.~      One of the common side-effects of this drug is bilateral, symmetric, progressive and usually~     irreversible sensorineural hearing loss.~      Cisplatin induces cochlear toxicity by the production of reactive oxygen species (ROS).~      Dexamethasone treatment is currently practiced for various pathologies afflicting the inner~     ear. The positive effect of Dexamethasone is attributed to it's anti ROS activity and it's~     capability to up-regulate cochlear anti ROS enzymes.~      In order to reach higher inner ear concentration of the drug while avoiding it's undesirable~     systemic side-effects, Intratympanic (IT) delivery of Dexamethasone became vastly used in the~     last decades for the treatment of sudden sensorineural hearing loss and Meniere's disease.~      Dexamethasone inserted IT, diffuse across the round window into the inner ear perilymph where~     it exerts its therapeutic effects.~      The investigators review of the literature yielded three animal studies which examined the~     protective effect of IT dexamethasone in the prevention of cisplatin-induced hearing loss.~     These studies demonstrated promising results pointing to the potential for IT dexamethasone~     in the prevention of cisplatin ototoxicity in humans.~      The purpose of this study is to examine possible protective effect of IT dexamethasone on~     cisplatin-induced hearing loss, in humans.~      The study hypothesis is that IT dexamethasone treatment would prevent cisplatin-induced~     hearing loss.~   "
167522|NCT01372891|"~     The present study is to determine the ability of urinary total adiponectin and its isoforms~     excretion in the prediction of contrast induced nephropathy (CIN) in the patients undergoing~     PCI.~   "
167523|NCT01372878|"~     This study was design to establish the effectiveness of PillCam® Platform with the PillCam®~     COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to~     optical colonoscopy.~   "
167524|NCT01372865|"~     The primary objective will be to compare the impact of the study formulations on alergic~     rhinitis carriers.~   "
167525|NCT01372852|"~     The objective of present study were to compare plasma adiponectin isoform status, their~     bioactivities newly diagnosed Chinese with healthy volunteer.~   "
167526|NCT01372839|"~     Compare with regular regimen, the aim of this study is to testify whether having more statin~     during PCI will benefit in Chinese population, and to find out optimal dose of the drug for~     patient after PCI.~   "
167527|NCT01372826|"~     This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal~     impairment compared to that in subjects with normal renal function.~   "
167528|NCT01372813|"~     Background:~        -  One way tumors are able to grow is by forming new blood vessels that supply it with~          nutrients and oxygen.~        -  Vandetanib (ZD6474) is an experimental drug that blocks certain proteins on the surface~          of tumor and blood vessel cells that are involved with the formation of new blood~          vessels.~        -  Blocking these proteins may prevent the tumor cells or blood vessels from continuing to~          grow.~      Objectives:~        -  To determine whether vandetanib can cause tumors to shrink or stabilize in patients with~          advanced kidney cancer.~        -  To determine how vandetanib may work in people with kidney cancer and to develop tests~          that may be helpful in studying kidney cancer.~      Eligibility:~      -Patients 18 years of age or older with advanced clear cell kidney cancer whose disease has~     worsened after treatment with one or more of the following drugs: sunitinib, sorafenib,~     interleukin-2 and temsirolimus; or patients who have had to stop treatment with these drugs~     due to unacceptable side effects; or patients who are unable to receive standard treatment.~      Design:~        -  Patients take a vandetanib pill once a day in 28-day cycles.~        -  Patients are followed in the clinic every 2 weeks during the first month of treatment~          and then every 4 weeks for a physical examination, blood and urine tests,~          electrocardiogram and a review of any drug side effects.~        -  Patients have imaging scans (computed tomography (CT) or magnetic resonance imaging~          (MRI)) about every 8 weeks to monitor tumor growth. MRI scans are also done to look at~          tumor blood flow when treatment begins, 24 hours after the first dose of treatment, and~          again about 4 and 8 weeks after starting treatment~        -  Optional tumor biopsies (surgical removal of a sample of tumor tissue) may be done~          before starting vandetanib treatment and after 4 weeks of treatment to look for drug~          effects on the tumor.~   "
167529|NCT01372800|"~     Adiponectin (Ad) is an abundant protein in human body, and reports have shown that it act as~     a novel risk factor for brain and heart ischemia injury. This 5 years follow-up study will~     focus on serum adiponectin concentration, activity and isoforms in Chinese population and its~     correlation to these diseases.~   "
167530|NCT01372787|"~     This clinical trial studies the quality of life and care needs of patients with persistent or~     recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer. Studying quality of~     life in patients with cancer may help determine the effects of gynecologic cancer and may~     help improve the quality of life for future cancer survivors.~   "
167804|NCT01369199|"~     The investigators propose to evaluate the safety and efficacy of a short lead-in course (8~     weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40~     weeks. The investigators hypothesize that using a potent nucleos(t)ide analogue will provide~     a higher rate of loss of HBeAg loss and suppression of Hepatitis B virus (HBV) DNA.~   "
167533|NCT01372748|"~     The primary aim of the trial is to compare survival to hospital discharge after continuous~     chest compressions (CCC) versus standard American Heart Association (AHA) recommended~     cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients~     with out-of-hospital cardiac arrest (OOHCA). The primary null hypothesis will be that the~     rate of survival to hospital discharge is not affected by use of continuous compressions with~     passive or positive pressure ventilation (intervention group) versus CPR with compressions~     interrupted for ventilation at a ratio of 30:2 (control group).~   "
167534|NCT01372735|"~     The current standard treatment for patients with primarily resectable pancreatic tumors~     consists of surgery followed by adjuvant chemotherapy. But even in this prognostic favourable~     group, long term survival is disappointing because of high local and distant failure rates.~     Postoperative chemoradiation has shown improved local control and overall survival compared~     to surgery alone but the value of additional radiation has been questioned in case of~     adjuvant chemotherapy. However, there remains a strong rationale for the addition of~     radiation therapy considering the high rates of microscopically incomplete resections after~     surgery. As postoperative administration of radiation therapy has some general disadvantages,~     neoadjuvant and intraoperative approaches theoretically offer benefits in terms of dose~     escalation, reduction of toxicity and patients comfort especially if hypofractionated~     regimens with highly conformal techniques like intensity-modulated radiation therapy are~     considered.~      Therefore the NEOPANC trial has been designed as a prospective, one armed single center study~     to investigate a combination of neoadjuvant short course intensity-modulated radiation~     therapy (5x5 Gy) in combination with surgery and intraoperative radiation therapy (15 Gy)~     followed by adjuvant chemotherapy according to german treatment guidelines in patients with~     primarily resectable pancreatic cancer. The primary objectives of the NEOPANC trial are to~     evaluate the general feasibility of this approach and the local recurrence rate after one~     year. Secondary endpoints are progression-free survival, overall survival, acute and late~     toxicity, postoperative morbidity and mortality and quality of life.~   "
167535|NCT01372722|"~     Hypothesis to be tested:~      Bilateral Deep Brain Stimulation to the Nucleus Accumbens is associated with clinically and~     statistically significant improvement in patients with treatment resistant bipolar disorder.~      Overall Objective:~      The aim in this interdisciplinary, psychiatric-neurosurgical project is to evaluate safety~     and efficacy of bilateral Deep Brain Stimulation to the Nucleus Accumbens (NAcc) using the~     Medtronic Activa RC Neurostimulator in patients with treatment resistant Bipolar Disorder.~   "
167536|NCT01372709|"~     This is a prospective observational post-market study of subjects receiving the Ovation™ or~     Ovation Prime™ Abdominal Stent Graft System (Ovation™ or Ovation Prime™ Abdominal Stent~     Graft System Post-Market Study) in the treatment of abdominal aortic aneurysms (AAA). The~     Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to~     expand the clinical knowledge base by collecting data on subjects treated with the Ovation™~     or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following~     commercial approval.~   "
167537|NCT01372696|"~     The purpose is to investigate whether polyps that look different at colonoscopy, have formed~     via different mutations and have different risks of turning into cancer.~   "
167538|NCT01372683|"~     This study is designed to test the hypothesis that on an equivalent calorie basis, oat based~     breakfast cereals do not provide the same satiety benefit. The study will also demonstrate~     the satiety comparison of the cereals related to product density.~   "
167539|NCT01372670|"~     The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment~     of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with~     an eating disorder who are underweight. The investigators want to find out if hydroxyzine~     given before meals will improve meal-related anxiety compared to no hydroxyzine.~   "
167540|NCT01372657|"~     Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement~     methods before and after cataract surgery improved formulas are tried be developed.~   "
167541|NCT01372644|"~     Atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) increases breast~     cancer risk. In post menopausal women, SERMS are standard chemopreventive agents. The~     investigators have previously shown insulin-like growth factor-I (IGF-I) is required to~     permit estrogen (E2) and progesterone action in the mammary gland, and that a novel~     somatostatin analog, SOM230, that inhibits IGF-I action can prevent E2 action on the mammary~     gland. It reduces cell proliferation and increases apoptosis (cell death) in the rat mammary~     gland. This study was designed to determine whether women at high risk for breast cancer~     respond to SOM230 in the same way that rats do. Methods: Women with atypical ductal~     hyperplasia or lobular carcinoma in-situ by core biopsy were treated for 9.5 days with SOM230~     (600mcg BID). Surgical excision was performed on day 10. Sections were examined before and~     after SOM230 treatment for cell proliferation (Ki67) and apoptosis (TUNEL). Serum IGF-I,~     fasting glucose, insulin, and HbA1C were measured in anticipation of changes.~   "
167542|NCT01372631|"~     The goal of this research is to further develop novel optical assay systems for intra~     operative assessment of tumor margins in partial mastectomy or mastectomy specimens.~   "
167543|NCT01372618|"~     This will be a proof of principle clinical trial to evaluate the use of pasireotide (SOM230)~     in women with ductal carcinoma in situ (DCIS) of the breast. Surgery and radiotherapy are~     used as treatment for DCIS and subsequent treatment with antiestrogens has been effective in~     reducing the occurrence of invasive breast cancer. Unfortunately, treatment with~     antiestrogens carries potential serious side effects and toxicities that are intolerable to~     some patients. Preliminary data suggest that inhibition of IGF-1 action in the breast will be~     at least as effective as tamoxifen. Pasireotide is a somatostatin analog that prevents~     mammary development by inhibiting IGF-1 action directly in the mammary gland and also~     indirectly without causing menopausal symptoms. This study is an expansion of work that we~     have previously done in women with atypical hyperplasia of the breast, which showed that~     treatment with pasireotide for 10 days caused a reduction in the cellularity of these~     precancerous lesions. In our present study, women with DCIS will be treated with pasireotide~     for 20 days prior to surgical excision. Endpoints will be as follows:~        1. To determine whether pasireotide will inhibit cell proliferation and angiogenesis (signs~          of tumor growth), and stimulate apoptosis (cell death) in surgically excised tissue in~          comparison to core biopsies from women with estrogen receptor (ER) positive DCIS. Both~          the core biopsy and surgical excision are standard of care procedures that women with~          DCIS have regardless of participation in this trial.~        2. To use dynamic contrast enhanced MRI to assess patients before and after treatment with~          pasireotide and evaluate for changes in tumor volume and other tumor related features~        3. In our previous study we found that many women experienced a slight elevation in blood~          sugar with 10 days of treatment with pasireotide. Other work has shown that this effect~          often resolves with greater duration of treatment. We are therefore expanding the~          duration of treatment in this study to 20 days to assess if the initial hyperglycemia~          seen with pasireotide improves as treatment duration progresses.~   "
167544|NCT01372605|"~     This project will integrate a depression treatment and brief medication adherence counseling~     intervention into clinical care at three HIV clinics and will use a randomized controlled~     trial to assess whether, relative to usual care, the intervention leads to improved HIV~     medication adherence. The depression treatment intervention uses a model known as~     Measurement-Based Care which equips Depression Care Managers with systematic measurement~     tools, a decision algorithm, and psychiatric backup and trains them to provide decision~     support to HIV clinicians to implement, monitor, and adjust antidepressant therapy.~   "
167545|NCT01372592|"~     The Spine TRACK Spinal Surgery Registry is a prospective multi-center observational data~     collection initiative, to capture clinical and radiographic outcomes in candidates for spine~     surgery with degenerative, deformity, and traumatic pathologies. As an observational~     database, there are no initial driving hypotheses, but rather data will be mined to answer~     unforeseen questions, but which may include broad topics such as comparative effectiveness~     between and among various surgical treatment options, and/or outcomes in various subgroups of~     patients such as defined by demographics, comorbidities, indications and symptoms, treatment~     variables, and/or outcome variables.~   "
167546|NCT01372579|"~     This phase II trial studies how well giving eribulin mesylate and carboplatin together before~     surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used~     in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed.~   "
167547|NCT01372566|"~     The goal of this study is to assess the safety, tolerability and effectiveness of platelet~     rich plasma in the treatment of photoaged skin. This study will be divided into two parts.~     The first part will assess the safety and tolerability of platelet rich plasma injections as~     compared to sterile saline injections in subjects' arm with six months follow-up. The second~     part will assess the effect of platelet rich plasma on the appearance of facial skin in a~     split face study with platelet rich plasma injections on one side of the face and sterile~     saline on the other. Outcomes will be recorded for twelve months.~   "
167548|NCT01372553|"~     -  Genomic medicine, using genetic information to improve health outcomes, is heralded as~          the answer to rising medical costs by focusing on prevention and tailored care. Despite~          its potential, little investigation has focused on how genomic medicine can be applied~          in health care. To be effective, it requires new ways to learn, deliver, and communicate~          medical information. It will also raise new ethical questions.~        -  The overall goal of Guilford Genomic Medicine Initiative (GGMI) is to identify the~          specific challenges in re-structuring an existing medical system to integrate genomic~          medicine, and create solutions that can be used by other medical systems, such as the~          extensive military medical care system. To accomplish this goal, GGMI includes the~          development of a large-scale genomic medicine education initiative targeted at the~          community, providers, and patients, and a clinical systems model to implement strategies~          to facilitate the integration of genomic medicine into several pilot practices.~   "
167549|NCT01372540|"~     This study is divided into study groups, as described below. The goal of Groups 1A and 2A of~     this clinical research study is to find the highest tolerable dose of the combination of~     ARRY-520 and carfilzomib that can be given to patients with multiple myeloma or plasma cell~     leukemia.~      The goal of Groups 1B and 2B of this study is to learn if the combination of carfilzomib and~     ARRY-520 can help to control multiple myeloma or plasma cell leukemia. Researchers would also~     like to learn if ARRY-520 can help carfilzomib to work in patients who have built up a~     resistance to carfilzomib or carfilzomib alone has not helped to control the disease.~      The safety of the study drugs will be studied in all groups.~   "
167550|NCT01372527|"~     Although there is considerable evidence that current health IT can improve certain elements~     of care, the most effective and efficient implementation of health IT systems for primary~     care population management are not currently known. Indeed, while many systems currently take~     a case-management approach to identify and address clinical care issues for high risk~     patients, no systems to our knowledge apply a risk-based approach that accounts both for~     adverse clinical outcome risk (e.g. breast cancer in a woman who has not had indicated~     screening for 4 years) and for clinical process risk (e.g. the likelihood that a specific~     patient will ignore a reminder letter and would therefore benefit from direct phone or in~     person contact). The investigators propose to directly test the hypothesis that implementing~     a health IT platform that 1) provides novel risk-based decision support using data derived~     from the electronic health record (EHR) and 2) leverages each clinician's unique knowledge of~     his or her patient panel will result in more effective and more efficient population-based~     primary care. The investigators will test this hypothesis in a practice-randomized clinical~     trial of preventive cancer screening within our primary care Practice-Based Research Network~     (PBRN).~   "
167551|NCT01372514|"~     The purpose of this study is to create an institutional registry of Thromboembolic disease~     through a prospective survey based on epidemiological data, risk factors, diagnosis,~     prognosis, treatment, monitoring and survival.~      The main goal is to describe the occurrence of thromboembolic disease and the characteristics~     of clinical presentation, evolution and predisposing factors of these episodes in the~     population of the Hospital Italiano de Buenos Aires.~   "
167552|NCT01372501|"~     The purpose of this study is to determine whether the GI Endobarrier Liner can be~     reimplanted.~   "
167582|NCT01372111|"~     Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for~     treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC),~     though many clinical questions remain. Prior experience has revealed locoregional control~     (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after~     treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and~     concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This~     multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL)~     and toxicity profile. The current trial is an attempt to maintain high LRC, while further~     minimizing both acute and chronic toxicities, and maximizing QOL.~   "
167805|NCT01369186|"~     Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and~     pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel,~     ticagrelor)~   "
167553|NCT01372488|"~     1. Hypothesis~           If patients who are sutured with non-absorbable sutures in the Emergency Department (ED)~          are provided with the proper equipment and knowledge on how to remove their own sutures,~          they will be willing and capable of removing their own sutures.~        2. Primary and Secondary Questions~      Primary Question What number of patients in the study group will successfully remove their~     own sutures if they are provided with the equipment and information on how to do so compared~     with a control group who are treated and advised in the usual fashion? (follow up with family~     doctor or local medical clinic for suture removal)~      Secondary Questions~        1. Number of complications related to self removal of sutures as compared to traditional~          treatment. Complications measured were wound infections, dehiscence and prolonged~          bleeding (>30 min)~        2. Number of physician visits related to self removal of sutures as compared to traditional~          treatment.~        3. Patient satisfaction and comfort level related to self removal of sutures as compared~          with traditional treatment.~   "
167554|NCT01372475|"~     Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a~     new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS]~     in subjects with symptomatic osteoarthritis of the knee.~   "
167555|NCT01372462|"~     Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive~     Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe~     Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during~     constant work rate exercise in subjects with severe COPD.~   "
167556|NCT01372449|"~     This study will attempt to study the effect of memantine, on memory, and motor~     praxis/expressive language skills in children with autism.~      The investigators will recruit children ages 6-12 years who are verbal and meet criteria for~     Autism Spectrum Disorder. The children will be assessed for memory function, expressive~     language output and motor skills/praxis. They will then be randomized to memantine or placebo~     for 6 months. The effects of this medication and its safety in this population will be~     studied over the 6 month period.~   "
167557|NCT01372436|"~     Identification of caries high risk subjects. Studying the relevance and the distribution of~     caries risk factors as defined by the HAS, and the part played by the zone of schooling~     (priority education area or not) Studying the interest of bacteriological tests using the~     technique of real-time PCR and the laser fluorescence device in the caries risk assessment~     Thanks to a prospective cohort study conducted over a period of 4 years on a representative~     sample of pupils and students chosen at random from the 360 primary schools and 89 high~     schools in the Alpes Maritimes (678 subjects).~   "
167558|NCT01372423|"~     The objective of this study is to evaluate the clinical equivalence and safety of the Test~     formulation of lubiprostone 24 mcg capsules compared to the marketed formulation AMITIZA®~     (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed~     chronic idiopathic constipation.~   "
167559|NCT01372410|"~     The purpose of this study is to further characterize the dose response of GSK573719 at doses~     of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary~     disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to~     further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the~     Handihaler will be included as an active control. A placebo treatment will be included in~     order to evaluate absolute treatment effect of the different doses of GSK573719.~   "
167560|NCT01372397|"~     The overall purpose of this study is to determine if weight loss is beneficial for obese~     patients with diastolic heart failure.~   "
167561|NCT01372384|"~     This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients~     with locally advanced, metastatic or recurrent non-small cell lung cancer who have not~     received previous chemotherapy for their disease and who present epidermal growth factor~     receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease~     progression or unacceptable toxicity occurs.~   "
167562|NCT01372371|"~     Hypothesis: Directly applying antibiotic powder onto the site of surgery along with~     perioperative intravenous antibiotics, before closing the wound, is more effective than~     intravenously applied perioperative antibiotics alone in controlling post-operative wound~     infection. The investigators also think powders that control both gram positive and gram~     negative bacteria are more beneficial.~   "
167563|NCT01372358|"~     The purpose of this study is to compare the relative bioavailability of ciprofloxacin 1000 mg~     ER tablets of Dr.Reddy's with that of CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation~     in healthy, adult, non-smoking subjects under non-fasting conditions.~   "
167564|NCT01372345|"~     The purpose of this study is to compare the relative bioavailability of ciprofloxacin 1000 mg~     ER tablets of Dr.Reddy's with that of CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation~     in healthy, adult, non-smoking subjects under fasting conditions.~   "
167565|NCT01372332|"~     The purpose of this explorative study, targeting subjects with homonymous visual field loss,~     is threefold:~      (i) to identify the perimetric / psychophysical method, that is most closely correlated with~     an individually assessed quality of life (QoL) score, using a validated questionnaire~     (NEI-VFQ 25) (ii) to determine, whether gaze-related (exploratory eye movements) or visual~     field-related (eyes steadily fixating) parameters are better for the characterization of the~     visual capacities that are necessary for activities of daily living (ADL), as represented by~     (iia) a standardized visual search task (supermarket special offer search task) (iib) by an~     on-road car driving pilot study.~   "
167583|NCT01372098|"~     The purpose of this study is to determine whether the Intimate Partner Violence (IPV)~     intervention in the context of Nurse-Family Partnership (NFP) program improves women's~     quality of life and reduces violence relative to the NFP alone using a cluster randomized~     controlled trial. Our hypothesis is that an IPV intervention can be designed that is~     acceptable to participants in the NFP, feasible to implement, and that this intervention will~     improve quality of life for women and reduce exposure to violence.~   "
167806|NCT01369173|"~     The foods eaten daily are considered the dietary pattern of a culture or country. The~     dietary pattern of Mexico is different from that of the United States. To look at the effects~     of these patterns, participants in this study eat a Mexican menu for three and a half weeks~     and an American menu for the same length of time. At the beginning and end of each menu~     period participants provide blood and urine samples which we analyze to compare the effects~     of each diet. More info at www.ProyectoCOMIDAS.info~   "
167566|NCT01372319|"~     The purpose of this explorative study, targeting subjects with advanced binocular~     glaucomatous visual field loss, is: (i) to identify the perimetric / psychophysical method,~     that is most closely correlated with an individually assessed quality of life (QoL) score,~     using a validated questionnaire (NEI-VFQ 25), (ii) to determine, whether gaze-related~     (exploratory eye movements) or visual field-related (eyes steadily fixating) OR~     attention-related parameters are better for the characterization of the visual capacities~     that are necessary for activities of daily living (ADL), as represented (iia) by a~     standardized visual search task and (iib) by an on-road car driving feasibility study.~      Further this study is intended to introduce and analyse a novel diagnostic method for~     recording and evaluating exploratory eye movements (gaze-related perimetry) in a clinical~     setting. A similar procedure has recently been introduced by Murray et al. However, their~     set-up is based on a video monitor and, therefore, restricted to the central visual field~     (eccentricity < 25°) and limited with regard to the dynamic range of the stimulus luminance.~     Since our new gaze-related perimetry is designed to be implemented in a conventional cupola~     perimeter, it should be widely available as a potent diagnostic tool, for screening purposes,~     or for clinical surveys by general ophthalmologists or clinical research groups.~   "
167567|NCT01372306|"~     Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.~   "
167568|NCT01372293|"~     An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify~     for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has~     been suggested in previous studies.~      Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors,~     the investigators hypothesis is that women with PCOS and with the variant allele G have a~     poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive~     pill (OCP) treatment for 6 months.~   "
167569|NCT01372280|"~     Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting~     condition.~   "
167570|NCT01372267|"~     The present intervention is a Stage II randomized controlled efficacy trial of a group-based~     intervention that integrates Cognitive Behavioral Therapy (CBT) for pain and substance use~     disorders (SUDs) compared to a Supportive Psychoeducation Control (SPC) group in a sample of~     patients receiving residential SUD treatment with co-occurring chronic pain. A total of 452~     patients (226 male and 226 female) with current pain rated as moderately severe or greater~     and comorbid drug or alcohol use disorder(s) will be recruited from a large residential SUD~     treatment program. These participants will be randomly assigned to either a 4-week~     (8-session) group of integrated CBT for pain and SUDs or a 4-week (8-session) SPC group. All~     participants will be re-assessed immediately post-treatment (1 month) and again at 3, 6, and~     12 months post-intervention. Through this randomized controlled trial, the investigators hope~     to gain insight on how to improved treatment of pain in those with SUDs that could result in~     enhanced quality of life and improved pain-related, substance use, and other health outcomes.~     Evaluating a psychosocial intervention for pain and substance use that can be delivered~     during a SUD treatment episode would significantly extend available treatment options for the~     large numbers of patients with pain seen by SUD treatment providers. The investigators also~     hope to determine the efficacy of an evidence-based psychosocial pain management approach in~     men and women from a large and diverse residential addiction treatment program.~   "
167571|NCT01372254|"~     The objective of the proposed project is to develop a novel, behavioral approach to smoking~     cessation that can be integrated with residential drug use treatment for low income substance~     using smokers with elevated depressive symptoms. The approach utilizes behavioral activation~     strategies which have been shown to reduce smoking among community samples and which can be~     easily targeted for the particular needs of low income substance users.~   "
167572|NCT01372241|"~     The purpose of this study is to determine whether a faith-placed lay health advisor~     intervention is effective in increasing use of Pap smears among middle-aged and older~     Appalachian women.~   "
167573|NCT01372228|"~     The goal of this research study is to establish chimerism and avoid graft-versus-host-disease~     (GVHD) in patients with inherited metabolic disorders.~   "
167574|NCT01372215|"~     In this study, participants, who are scheduled to have a breast biopsy, will have several~     extra spot mammogram images taken of the suspicious area. These images will be acquired with~     varying levels of compression. The images will then be analyzed to determine whether the type~     of lesion (malignant or benign) can be determined from the image data alone. The biopsy~     results will be used as a gold standard to determine the true malignancy status~   "
167575|NCT01372202|"~     This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum~     Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status~     in Diagnostic Biopsies.~   "
167576|NCT01372189|"~     The study aims to:~        1. Achieve molecular imaging of EGFR in patients with colorectal neoplasia in vivo using~          confocal laser endomicroscopy.~        2. Compare the results of in vivo EGFR-specific molecular imaging with CLE and ex vivo~          immunohistochemistry .~   "
167577|NCT01372176|"~     An increasing number of patients survive critical illness and intensive care, but describe~     having impaired physical function several years after discharge as a consequence of extensive~     loss of muscle mass. Reasons for loss of muscle mass and physical function are multiple, but~     insufficient nutrition is likely to contribute.~      This randomised trial will investigate the effect of an optimised nutrition therapy during~     intensive care, on short term clinical outcome and physical quality of life. We hypothesise,~     that early nutritional therapy, directed towards patient-specific goals for energy and~     protein requirements, will improve both short- and long-term outcomes.~   "
167578|NCT01372163|"~     The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after~     administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to~     evaluate the plasma drug concentrations after multiple doses.~   "
167579|NCT01372150|"~     This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release~     vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive~     Disorder (MDD).~   "
167580|NCT01372137|"~     This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to~     identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in~     patients with anemia of chronic disease (inflammation).~   "
167584|NCT01372085|"~     This is a single-centre, placebo-controlled, two-part study in healthy subjects.~      Part A will be a single dose, single period, placebo-controlled pilot study to explore the~     safety, tolerability, absorption and pharmacodynamic (effect of drug on a biological~     marker-pS6 levels in skin biopsies) of a single dose of 25 mg LY2584702 Reference formulation~     (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily~     evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of~     LY2584702.~   "
167585|NCT01372072|"~     Noninvasive ventilation (NIV) is a form of ventilation delivered by a mask and is an~     important mode of treatment in patients with both acute and chronic respiratory (breathing)~     failure. Humidification is widely accepted as an essential part of the ventilation strategy~     in patients receiving invasive ventilation (i.e. via a tube inserted into the mouth), but its~     role during NIV use is not proven. Consequently, there is a variation in practice with regard~     to humidification during NIV. Humidification is important in maintaining upper and lower~     airway mucosal function and patients requiring NIV often report symptoms, such as throat~     dryness, due to a lack of airway humidity. Success of NIV in the acute setting is dependent~     on many factors including, patient tolerance of NIV during the acute phase. In patients with~     chronic obstructive airways disease (COPD), poor tolerance results in NIV failure, which~     necessitates endotracheal intubation or treatment failure. Furthermore, invasive ventilation~     increases the risk of a hospital acquired pneumonia, which is associated with a worse~     outcome. In the long term setting of NIV use, again patients frequently report symptoms due~     to drying of the airways and adherence to NIV can be highly variable. Adherence in these~     patients is important in improving both quality and length of life. Humidification devices~     may be technically effective, but clinicians have concerns regarding potential negative~     effects of these devices. There is a requirement to evaluate the use of humidification in~     both the acute and long term use of NIV, particular, in terms of patient ventilator~     interaction, which will impact on comfort and adherence to NIV. This will effect the overall~     effectiveness of ventilation. The investigators propose a randomised controlled trial to~     investigate the effects of a humidification system during noninvasive ventilation.~   "
167586|NCT01372059|"~     The initiative to the study is based on the fact that various forms of enriched environments~     and multimodal stimulation are found to have positive influences on motivation and~     psychosocial well-being and have been shown to facilitate multiple processes in the brain~     leading to structural regeneration and functional recovery. Since there is a lack of~     rehabilitation programs that encompass all dimensions of a stroke survivor's life researchers~     agree upon the need for a rehabilitation program that addresses both the social and physical~     needs of the patients. The aim with the project is to investigate whether it is possible to~     improve the life situation among patients with a history of stroke through a rhythm and music~     method and therapeutic riding. To get insights in the underlying mechanisms our research also~     focuses on relevant physiological, neurobiological and psychosocial mechanisms induced by the~     interventions. The hypothesis is that both treatment methods will mainly enhance~     participants' degree of participation.~      The study is a randomized controlled trial where about 123 participants (50-75 years old) who~     had their stroke incident 1 - 5 years ago will be consecutively included and randomly~     allocated to the following three groups: a) Ronnie Gardiner Rhythm Music Method (RGRM) b)~     therapeutic riding c) a control group receiving RGRM after 9 months. Treatment proceeds~     during 12 weeks and evaluation takes place pre- and post intervention, and 12 and 24 weeks~     after the treatment is finalized. The evaluation consists of a thorough neuropsychological~     assessment, a physiotherapeutic assessment, sampling of blood and questionnaires covering~     mental, psychosocial, physical and psychological well-being. Interviews are also conducted in~     order to map the participants' experiences from the two treatment programs. Specially~     designed interviews are also planned to be carried through with participants having aphasia.~      So far, there is only empirical support suggesting that RGRM has positive effects for~     individuals with a history of stroke making it significant to carry out research with the aim~     to contribute to strengthening the evidence of the method. A positive outcome would increase~     the scientific basis for this alternative treatment thus facilitating further research and~     implementation in everyday clinical practice.~   "
167587|NCT01372046|"~     1. Assess the impacts of implementing a juvenile assessment, referral, placement, and~          treatment planning (J-ARPP) protocol, and of different strategies for transferring~          J-ARPP technology, on service utilization of youth entering the juvenile justice system.~        2. Assess the impacts of implementing J-ARPP, and of different strategies for transferring~          J-ARPP technology, on measures of organizational readiness and motivation, and staff~          attitudes about assessment and service.~        3. Assess the impacts of implementing J-ARPP, and of different strategies for transferring~          J-ARPP technology, on measures of systems integration.~        4. Assess fidelity to the J-ARPP protocol and the relationship between fidelity to the~          J-ARPP protocol and service utilization of youth entering the juvenile justice system.~   "
167588|NCT01372033|"~     The specific aims of this project are:~        1. To conduct a randomized block experiment to test the effectiveness of different models~          of the seamless supervision/treatment system and traditional criminal justice~          supervision on reducing recidivism and drug use, and improving social adjustment among~          offenders;~        2. To understand the differential impacts based on offender risk factors (e.g., propensity~          to engage in further criminal behavior) on criminal justice outcomes and to determine~          whether differences found between seamless and traditional system participants are~          moderated by offender risk level;~        3. To understand differential treatment and social adjustment outcomes (e.g., treatment~          progress, employment status) of different types of offenders participating in various~          treatment services; and~        4. To examine levels of systems and service integration between the supervision and~          treatment systems pre- and post-intervention and to measure the impact of integration on~          outcomes over time.~   "
167589|NCT01372020|"~     The use of neuromuscular electrical stimulation in the treatment of venous ulcers with~     difficulty of repair could be an alternative therapeutic favoring devitalized tissues and~     hence the pain.~      The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on~     pain and area of venous ulcers in patients with venous insufficiency.~   "
167590|NCT01372007|"~     Total mesorectal excision (TME) is a precise dissection of the rectum and all para-rectal~     lymph nodes within the mesorectal envelope. It is becoming universally recognized and~     accepted as the standard technique for surgical excision of rectum carcinomas. TME results in~     lowest rates of local recurrence, especially when combined with pre-operative~     chemo-radiotherapy.~      Especially after pre-operative chemo-radiotherapy, the post-operative drainage may be~     important. The quick decrease of this drainage will enable the early mobilisation of the~     patient and may shorten the time of hospitalization. If this decrease in fluid production can~     be achieved, it will have a positive effect on the Quality of Life of the patient and will~     ensure health economic savings by reduction of hospitalization time and resources.~      Somatostatin analogues have shown to be able to decrease the secretion of numerous types of~     bodily fluids.~      The aim of this study is to investigate if lanreotide Autogel 120mg is capable to reduce the~     fluid discharge in patients that underwent a TME for rectumcarcinoma.~      Lanreotide Autogel 120mg compared to placebo, administered post-surgery on the fluid~     discharge in the drain of the patient that underwent a total mesorectum excision (TME) for~     rectal carcinoma. Patient planned to have a TME will be asked to participate in the study.~     When they have provided written informed consent, they will be randomized 1:1 to receive~     either placebo or lanreotide autogel 120mg. Drain fluid will be checked for hematocrit daily~     post-surgery. Once hematocrit levels of the drain fluid are <10%, study medication or placebo~     will be administered. After administration the volume of the drain fluid will be measured~     every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24~     hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride~     analysis afterwards. If the patient has a hematocrit >10% in his drain fluid for a period of~     5 days, this patient can not be randomized.~   "
167591|NCT01371994|"~     The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of~     solifenacin succinate versus placebo in participants who are incontinent after Robotic~     Assisted Radical Prostatectomy.~      This study will also assess the effect of 12 weeks of treatment with solifenacin succinate~     versus placebo on quality of life (QOL) as measured by questionnaires.~   "
167592|NCT01371981|"~     This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in~     treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib~     tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving bortezomib and~     sorafenib tosylate together with combination chemotherapy may be an effective treatment for~     acute myeloid leukemia.~   "
167593|NCT01371968|"~     This study aims to determine the optimal dose of alfentanil in suppressing the airway~     reflexes during supreme LMA removal in anaesthetized adult.~   "
167594|NCT01371955|"~     The physiopathology of diabetic nephropathy (DN) is unclear. To investigate risk factor, the~     investigators choose to look about some oxidative stress genes. Today a one-gene explanation~     is not really possible. So the theory of some genetic predisposition to DN is more likely.~      The aim of the study is to look about the association of the C282T polymorphism of P22phox, a~     sub unit of the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH oxidase) in the~     occurrence of DN. To follow the oxidative stress pathway of the DN, the investigators also~     investigate three other polymorphisms: -429 T/C, -374 T/A polymorphism of advanced glycation~     end-products receptor (AGER) and the p.Arg261Gln polymorphism of the 12 lipoxygenase (ALOX~     12). Discordant data suggest a link between the first 2 polymorphisms and DN. The last~     polymorphism is correlated to albuminuria in diabetic patients.~   "
167595|NCT01371942|"~     The aim of this study is to investigate mutational changes occurring in colorectal tumors,~     from benign polyps, malignant cancer and metastatic tumors. The investigators also plan to~     establish the clinical correlation, emphasizing on aspects such as the diagnosis and~     prognosis of disease and the specific treatment outcome. For the purpose, the investigators~     plan to obtain specimens from patients with colorectal tumors to extract DNA material. The~     specimens include tissues from either primary (mostly endoscopic biopsies specimens) or~     metastatic tumors (obtained from sonogram or other imaging modalities guided biopsy), as well~     as other humors including blood (for serum), malignant ascites, pleural effusions or other~     body fluids that could be related to CRCs. These patients would receive detailed explanations~     with regard to the investigations before signing IRB consent. At the initial stage, Wanfang~     Medical Center would be the only medical institution where endoscopic specimens would be~     collected. The project would eventually be extended to the Taipei Medical University Hospital~     and Shuan-Ho Hospital.~   "
167596|NCT01371929|"~     The primary objective is to demonstrate that the plasma inducible nitric oxide synthase~     (iNOS) assay (PliNOSa® test) has an acceptable relative risk ratio for predicting the onset~     of sepsis within 72 hours of testing when performed on the first day a patient is admitted or~     transferred to the intensive care unit (ICU) and is considered to be at risk of becoming~     septic. The PliNOSa® test measures inducible nitric oxide synthase (iNOS) in plasma and uses~     a pre-determined iNOS cut-off value to identify patients at risk for the onset of the sepsis~     pathology.~   "
167597|NCT01371916|"~     Early and reliable diagnosis of tuberculous meningitis (TBM) still poses a great challenge.~     One of the underlying difficulties is due to the fact that tubercle bacilli are mainly not~     present in the cerebrospinal fluid (CSF) but in the phagocytotic macrophages. The present~     study was designed to demonstrate early secretory antigenic target 6 (ESAT-6), a~     mycobacterium-specific antigens, in the macrophages in infected CSF samples and compare the~     efficiency of this antigen in the laboratory diagnosis of TBM.~   "
167598|NCT01371903|"~     Emergency department patients receiving opioid pain medicine such as morphine, fentanyl or~     Dilaudid are eligible. After medication exhaled carbon dioxide is measured. and recorded.~   "
167599|NCT01371890|"~     The purpose of this study is to determine the role of dialysate exposure and fluid removal~     during hemodialysis in the pathophysiology of intradialytic hypertension.~   "
167600|NCT01371877|"~     This clinical study was designed based on our hypothesis that vitamin D plays an important~     role in chronic urticaria and that high dose supplementation with vitamin D in subjects with~     chronic urticaria will improve clinical response.~      This clinical study will investigate our hypothesis in three Specific Aims:~        1. Determine whether high dosing vitamin D supplementation (4000 IU/day) reduces medication~          usage (primary outcome) and urticaria severity score (secondary outcome) in subjects~          with chronic urticaria as compared to low dosing (600 IU/day).~        2. Determine if high dosing of vitamin D (4000 IU/day) is safe and well-tolerated in~          subjects with chronic urticaria with or without baseline vitamin D deficiency.~        3. Investigate whether there is an association with serum 25-hydroxyvitamin D levels,~          vitamin D receptor mRNA expression, and chronic urticaria severity.~   "
167601|NCT01371864|"~     Purpose:~      -To evaluate the peri-operative communication between families and the pediatric cardiac~     surgery team.~      Method:~      -In this study the investigators plan to utilize structured interview and survey of~     parents/legal guardians and health care providers of children undergoing cardiac surgery in~     the United States of America.~   "
167602|NCT01371851|"~     Psychostimulant dependence is a major public health problem and no medications have been~     shown to be very effective in treating this disorder. Thus, the investigators wish to study~     whether a blood pressure drug thought to reduce drug craving through its interaction at~     particular adrenergic receptors - doxazosin - can dredge cocaine use relative to placebo in~     psychostimulant dependent participants enrolled in an 8-week, randomized, double blind,~     placebo-controlled outpatient clinical trial. Our hypothesis is that doxazosin will reduce~     cocaine use relative to placebo in psychostimulant dependent participants.~   "
167603|NCT01371838|"~     This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline~     Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With~     Community-Acquired Bacterial Pneumonia in Asia.~   "
167604|NCT01371825|"~     This is an open-label, repeat-dose, intra-subject dose escalation study of SBC-102 (USAN:~     sebelipase alfa) in children with growth failure due to LAL Deficiency. Eligible subjects~     will receive once-weekly (qw) infusions of sebelipase alfa for up to 5 years~   "
167605|NCT01371812|"~     The purpose of this first time into human study is to investigate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of GSK2239633 in healthy male subjects.~   "
167606|NCT01371799|"~     This will be a double blind, randomised, placebo controlled, cross over study in which up to~     20 otherwise healthy male nicotine abstinent smokers will be tested following 3 acute~     treatment conditions (placebo, 4 and 8mg of GSK1034702). Each subject will undergo screening~     assessments within 30 days prior to administration of the first dose of study medication.~     There will be 3 treatment sessions and dosing will be separated by a minimum 1 week washout~     period. There will be two testing days (day 1 and day 2) per treatment session. On each~     treatment session subjects will be admitted on day 1. On day 1, subjects will be administered~     placebo and approximately 3 hours later, there will be a Baseline EEG/ERP recording,~     neuropsychological (Cogstate battery) testing and mood/craving/dependence questionnaire~     assessments . Subjects will be allowed to smoke until approximately midnight on day 1. On day~     2, subjects will undergo a pre-drug neuropsychological (Cogstate battery) testing and~     questionnaire assessments of mood/craving. This will be conducted approximately 1 hour prior~     to dosing. Subjects will be randomized to one of six treatment sequences. Post dose EEG/ERP~     recording, neuropsychological (Cogstate battery) testing and mood/craving measurements will~     be conducted between 3 and 6 hours post treatment to coincide with peak pharmacokinetic~     effects. This testing will be performed approximately at 12pm following at least 12hrs of~     nicotine abstinence. Blood samples will be collected at baseline (pre-drug) and following~     drug administration to quantify exposure levels.~   "
167607|NCT01371786|"~     This study is an open label, single dose, single site, randomized, cross over study that will~     assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide~     radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone~     furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14~     patients with symptomatic allergic rhinitis, aged 18-65 years.~   "
167608|NCT01371773|"~     The purpose of this study is to devise repositioning method of a left-sided double lumen tube~     into left mainstem bronchus in case of misplacement into right mainstem bronchus.~   "
167609|NCT01371760|"~     To assess in a double blinded randomized control trial (RCT) study design safety and~     effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in~     multiple sclerosis (MS) associated to chronic cerebrospinal venous insufficiency (CCSVI).~      Mean follow-up 1 year. 5-8 Italian centres 360 relapsing remitting (RR) MS patients will be~     randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.~   "
167610|NCT01371747|"~     This study determined the optimal starting dose of patiromer in treating hyperkalemia in~     participants with hypertension and diabetic nephropathy who were already receiving ACEI~     and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and~     safety of patiromer and the long term use of patiromer.~   "
167611|NCT01371734|"~     This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR)~     versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive~     Disorder (MDD).~   "
167612|NCT01371721|"~     This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate~     sustained release (DVS SR) in the treatment of child and adolescent outpatients with major~     depressive disorder (MDD).~   "
167613|NCT01371708|"~     This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate~     Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major~     Depressive Disorder (MDD).~   "
167614|NCT01371695|"~     The purpose of this study is to determine whether Insulin-like Growth Factor II is elevated~     sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical~     Intraepithelial Neoplasia III (CIN III), and cervical cancer.~   "
167615|NCT01371682|"~     This is an open-label, randomised, two-period crossover, single dose study to demonstrate~     bioequivalence between the extended release 2 mg ropinirole XL tablets manufactured at two~     different sites in healthy subjects. Dosing will be under fasting conditions and there will~     be a minimum one week washout between doses. Domperidone will be administered to control~     dopaminergic side effects. Pharmacokinetic samples will be taken following each dose. Safety~     assessments will include screening and follow-up vital signs, ECGs and safety laboratory~     tests. Vital signs and adverse events will be monitored periodically throughout the study.~   "
167616|NCT01371669|"~     In the investigators study, and regarding results of small cohorts in the literature, the~     investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators~     will explore these patients with a one night polysomnography and transcutaneous capnography,~     searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.~   "
167617|NCT01371656|"~     This randomized phase III trial studies how well levofloxacin works in preventing infection~     in young patients with acute leukemia receiving chemotherapy or undergoing stem cell~     transplant. Giving antibiotics may be effective in preventing or controlling early infection~     in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It~     is not yet known whether levofloxacin is effective in preventing infection.~   "
167618|NCT01371643|"~     This is a randomized, multicenter trial with stratification done by a single radiologist at~     the coordinating center (NYU), and patients with comparable disease will be randomized to~     Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before~     (Arm A) or, for non-cured patients, after (Arm B) surgery. All patients will undergo~     transsphenoidal hypophysectomy. The impact of surgical debulking on responsiveness to~     Sandostatin LAR will be evaluated.The primary objective of this trial will be to determine~     whether surgery (debulking of pituitary adenomas) improves the response of patients with~     acromegaly to treatment with Octreotide LAR, when compared to Octreotide LAR therapy alone.~   "
167670|NCT01370954|"~     This study will be an observational study in which patients who have been prescribed~     CerefolinNAC® are invited to participate in surveys regarding their experiences with~     CerefolinNAC®. CerefolinNAC® is a medical food indicated for the distinct nutritional~     requirements of individuals under treatment for early memory loss with particular emphasis~     for those individuals diagnosed with or at risk for neurovascular oxidative stress and/or~     hyperhomocysteinemia; mild to moderate cognitive impairment with or without vitamin B12~     deficiency, vascular dementia or Alzheimer's disease. The purpose of this study is to~     increase the understanding of the role of CerefolinNAC® in managing proper neuronal function~     in the brain, provide patients with personalized education and support, and contribute to the~     overall understanding of the needs and concerns of patients being treated for early memory~     loss.~   "
167619|NCT01371630|"~     If you are reading and signing this form on behalf of a potential participant, please note:~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of the Phase I part of this clinical research study is to test 2 dose levels of the~     drug inotuzumab ozogamycin to find the highest tolerable dose that can be given in~     combination with chemotherapy. The goal of Phase II is to learn if inotuzumab ozogamycin~     given in combination with chemotherapy can help to control acute lymphoblastic leukemia~     (ALL). The safety of the study drugs will also be studied.~      Participants in this study are at least 60 years of age and have newly diagnosed ALL or have~     refractory-relapsed ALL regardless of age.~      Inotuzumab ozogamycin is designed to attach to a protein that is often found in leukemia~     cells. This may cause the cancer cells to die.~      Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to~     die.~      Hyper-CVD includes a combination of cyclophosphamide, vincristine, dexamethasone,~     methotrexate, Ara-C (cytarabine), and Neulasta (pegfilgrastim). The maintenance therapy used~     in this study is called POMP, which includes a combination of mercaptopurine, methotrexate,~     vincristine, and prednisone. These chemotherapy drugs are designed to interfere with the~     multiplication of cancer cells, which may slow or stop their growth and spread throughout the~     body. This may cause the cancer cells to die.~      This is an investigational study. Inotuzumab ozogamycin, rituximab, Hyper-CVD, methotrexate,~     cytarabine, blinatumomab, and POMP maintenance drugs are FDA approved and commercially~     available for the treatment of leukemia. Combining inotuzumab ozogamycin with rituximab is~     investigational.~      Up to 256 patients will take part in this study. All will be enrolled at MD Anderson.~   "
167620|NCT01371617|"~     The purpose of this study is to determine the safety and efficacy of IPI-926 in patients with~     myelofibrosis (MF) (primary myelofibrosis [PMF], post-polycythemia vera myelofibrosis~     [post-PV MF], or post-essential thrombocythemia myelofibrosis [post-ET MF]).~   "
167621|NCT01371604|"~     The purpose of this study is to assess the safety and antiviral activity of IDX184 in~     combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype~     1 chronic hepatitis C virus (HCV) infection.~   "
167622|NCT01371591|"~     The researcher's primary hypothesis is that VCE allows for safe outpatient management of ED~     patients with suspected upper GI hemorrhage. A prospective multicenter randomized control~     trial was designed to investigate the safety of this approach.~   "
167623|NCT01371578|"~     This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response~     Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451)~     with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic~     Genotype 1 Hepatitis C Virus (HCV) Infection.~   "
167624|NCT01371565|"~     This is a compassionate use study. In addition to providing compassionate use access to~     mifepristone, objectives of the study will be to evaluate the safety and utility of~     mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when~     given on a compassionate use basis. The study will only enroll subjects whose physicians have~     determined that medical treatment is needed to control the symptoms or signs of~     hypercortisolemia.~   "
167625|NCT01371552|"~     The purpose of this study was to compare a new daily disposable, silicone hydrogel contact~     lens to marketed daily disposable, silicone hydrogel contact lenses.~   "
167626|NCT01371539|"~     The purpose of this study was to compare visual performance measures between two multifocal~     contact lenses on presbyopic wearers.~   "
167627|NCT01371526|"~     Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune~     attack progressively destroys the adrenal cortex. Untreated it is universally fatal and~     treated people are absolutely dependent upon steroid medications lifelong, with a consequent~     excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are~     responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This~     study aims to regenerate adrenocortical steroidogenic cell function in patients with~     established autoimmune Addison's disease (AAD) by stimulating proliferation and~     differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using~     daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we~     will investigate whether regeneration of adrenal steroidogenic function through revival of~     ACSC activity is a realistic possibility.~   "
167628|NCT01371513|"~     This is to investigate Korean urologist's practice patterns for screening prostate cancer~     according to PSA level.~   "
167629|NCT01371487|"~     The purpose of the this study is to evaluate the effect of a high-fat, high calorie meal on~     the single dose PK of GSK1120212 in subjects with solid tumors.~   "
167630|NCT01371474|"~     The objective of this survey was to understand the safety and efficacy of PAXIL tablets~     (PAXIL, hereinafter) when it was started at 20 mg/day in subjects with depression or in a~     depressed state.~   "
167631|NCT01371461|"~     Overall improvement, severities and changes of specific clinical symptoms were surveyed in~     outpatients with depression or in a depressed state to evaluate the efficacy and safety of~     PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a~     constant dose.~   "
167632|NCT01371448|"~     This surveillance study is designed to detect adverse events (particularly clinically~     significant adverse drug reactions) occurring in clinical settings and to examine factors~     likely to affect the safety and efficacy of paroxetine in long-term use (1 year).~   "
167633|NCT01371435|"~     This post-marketing surveillance study is designed to detect adverse events (particularly~     clinically significant adverse drug reactions) occurring in clinical settings and to examine~     factors likely to affect the safety and efficacy of paroxetine.~   "
167634|NCT01371422|"~     This is a randomized control trial (meaning the selection is random as when flipping a coin)~     to assess the benefit of paravertebral blockade (PVB) in Percutaneous~     nephrolithotomy/nephrolithotripsy (PCNL) surgery.~   "
167682|NCT01370798|"~     Hypospadias is a congenital abnormality of the penis that is caused by incomplete development~     of the anterior urethra. This pathology is one of the most common genital anomalies in~     paediatric urology .The incidence is reported to be 1 out of 250 live male births and is~     increasing regularly. The hypospadias surgeries present a high risk of post operative~     complications requiring re-interventions.~      A great part of the post operative complications is related to imperfect healing issues. If~     androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact~     positively on the skin healing process. This point leads to the hypothesis that local~     transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the~     number of skin healing post-operative defects.~      The objective of the study is to assess the effect of oestrogen (applied once daily for 2~     months prior to surgery) on the post-operative complications.~   "
167683|NCT01370772|"~     Phase II, multicenter, randomized trial, exploring intensified Rituximab prephase monotherapy~     before standard Fludarabine-Cyclophosphamide-Rituximab FC-R regimen in previously untreated~     symptomatic B-cell chronic lymphocytic leukemia CLL.~      A Study from the Goelams GCFLLCMW intergroup~   "
167635|NCT01371409|"~     After a stroke the excitability of the brain decreases on the stroke side and increases on~     the opposite, non-stroke side. These changes make use of the stroke-affected arm difficult~     and slow recovery. Rehabilitation exercises that increase arm use after stroke help increase~     brain excitability, but the net effect of this approach is low. New therapies are needed that~     restore more equal levels of brain excitability between the two sides. Brain stimulation is a~     noninvasive way to affect activity the excitability of brain cells. Pairing brain stimulation~     with exercises that require patients to learn new movements may help the brain to learn.~     Using stimulation that reduces activity in the side opposite to the stroke can increase~     activity on the stroke -affected side, through connections between the two brain hemispheres.~     The purpose of this study is to test if brain stimulation on the side opposite to the stroke,~     paired with arm movement exercises, can help patients learn new arm movements and improve arm~     function.~      In this study people with stroke will receive brain stimulation over two different areas on~     the side of the brain opposite to the stroke: 1) those areas responsible for movement and 2)~     those responsible for sensation. These experiments will test both the short and long term~     effects of brain stimulation on patients' learning and arm function and will allow us to~     identify which area of the brain best improves learning and arm function. These experiments~     have the potential to improve the effectiveness of rehabilitation after stroke. The proposed~     study is among the first to test stimulation over the side of the brain opposite to the~     stroke damage and at multiple sites. This unique approach may help stimulate the development~     of new methods for stroke rehabilitation.~   "
167636|NCT01371396|"~     The purpose of this study is to understand why Hispanics who are overweight have a higher~     incidence of fatty liver disease.~   "
167637|NCT01371383|"~     The first part is a double-blind placebo-controlled trial to identify the effects of omega-3~     polyunsaturated fatty acids (PUFAs) monotherapy in depression. The second part is a~     double-blind trial to identify the effects of eicosapentaenoic acid (EPA) and docosahexaenoic~     acid (DHA) on different symptom clusters in patients with depression.~   "
167638|NCT01371370|"~     -  Obesity is a major risk factor for premature arterial abnormalities including high blood~          pressure and increased stiffness. Previous studies have shown that weight loss via~          lifestyle modifications is associated with a decrease in large artery (aorta) stiffness.~          However, along with decreases in fat mass, hypocaloric diet reduces muscle mass.~          Low-intensity resistance exercise training (LIRET) results in similar increases in~          muscle mass and strength than those observed after high-intensity resistance exercise.~        -  The investigators hypothesis is that weight loss via diet combined with LIRET would~          additively reduce arterial stiffness and blood pressure (BP) in obese women. The~          investigators also hypothesize that the improved arterial function with weight loss~          would be associated with beneficial changes in the main mechanisms involved in BP~          regulation.~   "
167639|NCT01371357|"~     A methyl-group acceptor such as guanidinoacetic acid (GAA) could induce hyperhomocysteinemia~     with the effects of GAA expected to be dose-dependent. Due to the fact that~     hyperhomocysteinemia is thought to be an independent risk factor for cardiovascular and~     neurodegenerative diseases, different dietary agents were used in the past for the treatment~     of elevated total plasma homocysteine (T-HCy), e. g. betaine, choline (betaine precursor) or~     folic acid. In the context of GAA loading the question arises whether intake of betaine,~     choline (betaine precursor) or folic acid during GAA loading could affect plasma T-HCy in~     healthy humans. Forty healthy physically active men and women aged 20 to 30 years will take~     part in this GAA-controlled, double-blind and parallel-group intervention study. Subjects~     will be allocated to four randomly assigned trials, with treatment lasting for 8 weeks and~     washout period of 28 days. The 4 test treatment-groups will include TEST1 (GAA only), TEST2~     (GAA, choline, B6, B12 and folic acid), TEST3 (GAA, betaine, B6, B12 and folic acid) and~     TEST4 (GAA, B6, B12 and folic acid). Plasma T-HCy will be the primary outcome measure~     assessed every second week throughout the study. Plasma B-vitamins and blood and urine~     metabolites (GAA, creatine, methionine, arginine) will be secondary outcome measures along~     with adverse-effects indicators assessed every second week throughout the study. Selected~     body composition indicators will be obtained at 0, 2, 8 and 12 weeks throughout the study to~     monitor the effects of experimental treatments on body hydration and protein synthesis. This~     research will test the hypothesis that a combination of GAA with homocysteine lowering~     nutrients attenuates the elevation of T-hcy, and will further display the size-effect of each~     additive used.~   "
167640|NCT01371344|"~     The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and~     effective Modigraf® is (Part A) and to see how safe and effective it is to change your~     child's medication from Modigraf® to Prograf® (Part B).~   "
167641|NCT01371331|"~     The purpose of this study is to find out how much of Modigraf is absorbed and used in the~     body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide~     how much Modigraf in future can be given safely to children and young people following~     transplantation.~   "
167642|NCT01371318|"~     The purpose of this study is to determine whether using the OWEMR as part of the standard of~     care for Diabetic Foot Ulcers reduces the rate of lower limb amputations and to quantify the~     relationship between glycemic control and the rate of amputation secondary to chronic foot~     ulcers in Type II Diabetes.~   "
167643|NCT01371305|"~     The primary objective of this study is to evaluate the safety and tolerability of~     subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized~     monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as~     STX-100) in participants with IPF. The Secondary objectives are to estimate the~     pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple,~     escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011~     in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from~     bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.~   "
167644|NCT01371292|"~     The purpose of this Randomized Controlled Tria (RCT) is to evaluate the effects of a~     transformational teaching intervention in comparison to 'standard educational practices'~     within school-based physical education classes (within three Canadian provinces; British~     Columbia, Ontario and Nova Scotia) across 5 months.~   "
167684|NCT01370759|"~     The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.~   "
167645|NCT01371279|"~     This is a 2- component, single center study, witch aims to evaluate the efficacy of multisite~     intracardiac echocardiography (mICE) imaging of left atrial appendage (LAA) and in detecting~     thrombus located in LAA as compared to transesophageal echocardiography (TEE). The study~     group will consist of patients eligible for atrial fibrillation (AF) ablation procedure~     (Component I) or cardioversion (Component II).~      First component will enroll 100 patients; these patients will undergo clinically indicated~     TEE & cardiac catheterization procedures with ICE(AF ablation). Second component will enroll~     15-20 patients with AF or atrial flutter in whom a thrombus in LAA was detected by TEE prior~     to electrical cardioversion. The ICE probe will be located in multiple positions in the right~     atrium (RA), coronary sinus (CS), pulmonary artery (PA), right ventricular outflow tract~     (RVOT) and esophagus. This will enable the investigators to compare sensitivity and~     specificity of mICE and TEE.~      This study will examine two hypotheses in AF patients undergoing invasive cardiac procedures:~      Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of LAA from multiple~     positions (RA,CS,PA,RVOT and esophagus ). This will be evaluated during the component I of~     the study.~      Hypothesis 2: That ICE can identify low risk patients, CHADS Score < 2,0 in whom immediate~     cardioversion during the procedure is as safe as based on conventional strategy.~   "
167646|NCT01371266|"~     Honey has been used as a sweetener for centuries. Recent data indicate that honey consumption~     may have beneficial effects upon glucose intolerance, a health issue currently affecting 57~     million Americans of every age and ethnicity. In order to evaluate the glycemic effect of~     honey, the investigators will carry out a human trial assessing biomarkers of blood glucose~     responses, insulin sensitivity, oxidative stress, and inflammatory markers. Our primary~     objective is to determine the glycemic effects of honey in comparison to sucrose and high~     fructose corn syrup (HFCS). The investigators hypothesize that honey will promote improved~     glucose tolerance and insulin sensitivity compared to both sucrose and high fructose corn~     syrup in normal glycemic and glucose intolerant adults.~   "
167647|NCT01371253|"~     On a yearly basis roughly 40.000 individuals aged 65+ contact the emergency departments in~     Denmark as a result of an accidental fall, and in about 30% of these cases hospitalization is~     required. The cost of these admissions vary according to the type of injury with hip~     fractures being the most expensive accident {{113 Chrischilles,E. 1994; }}. The total average~     cost of a severe hip fracture in the Danish healthcare system resulting in nursing home~     placement has been estimated to approximately 365.000 Danish Kroner (Dkk) per year {{288~     Christensen,P.M. 2005;}}. In addition, about 20 % of the elderly individuals who sustain a~     hip fracture will die within 6 months {{200 Brot,C. 2006; }}. For the society the outcome of~     falling in the elderly population is therefore not only associated with severe human but also~     economical consequences. Hence, it is essential to refine, develop and think out of the box~     when future intervention programs are designed and employed in the elderly community.~      One such out of the box intervention could be balance training with a Nintendo Wii Fit~     board (Nintendo Wii, Nintendo Co Ltd, Minami-ku Kyoto, Japan). The Nintendo Wii Fit board is~     a new generation of computer game which uses 3D tracking of the participants' motion and~     gestures. This means that the user interacts in and controls elements of the 3D gaming world~     with their own body {{307 LaViola,J.J.,Jr 2008;}}. In the case of the Wii Fit board, it~     detects the body sway and center of pressure (COP) of the participant and displays it onto a~     TV screen in different balance sceneries. A virtual character on the TV then reacts according~     to the user's movement and gesture (ex. skiing down a ski slope passing thru gates). This~     enables the user to perform tasks that, they may not be able to execute safely or at all in~     real-world situations. Interestingly in this context a study by Sihvonen et al from 2004~     showed a compliance of 97,5% using the same technique as the Wii Fit only in 2D and with a~     poor graphical display. Further, the Sihvonen-study showed that 2D biofeedback intervention~     of only 4 weeks proved successful in terms of improved postural balance, physical activity~     and life quality {{297 Sihvonen,S. 2004;}}. Finally, traditional methods when promoting~     physical activity in the elderly population has been limited by lack of motivation or poor~     compliance (REFS), which possibly has prevented the elderly from reaching a maximum~     rehabilitation potential(REFS). Furthermore, in the follow-up period after these traditional~     intervention studies, it has been documented how difficult it is for the elderly to sustain~     the same training volume on themselves (REFS).~      Virtual reality systems like the Nintendo Wii Fit have been developed specifically for~     rehabilitation of the upper- {{301 Kuttuva,M. 2006;300 Dvorkin,A.Y. 2006;}} and~     lower-extremities and gait training {{298 Deutsch,J.E. 2007;}}. Further virtual reality~     platforms have been use for rehabilitation and training of reaching movements {{302 Piron,L.~     2001;}}, motor coordination {{303 Broeren,J. 2002;}}, hand strength and range of motion,~     speed of hand movement{{304 Jack,D. 2001;305 Merians,A.S. 2002;}}. But so far most of these~     systems have not become commercially available possible due to a very high cost {{294~     Deutsch,J.E. 2008;}}. Moreover in some cases the virtual rehabilitation environment has to be~     constructed from scratch making the hole process and implication very complicated {{306~     Weiss,P.L. 2004;}}. Thus, designing an intervention program that utilizes the low-cost~     ready-to-use Wii Fit platform could be a possible research direction to explore. At the~     moment few studies have been conducted using the Nintendo Wii console. Among the few some~     have investigated the energy expenditure in kids (11-17 years of age) playing Wii Sports~     (bowling, tennis and boxing) compared to sedentary xbox games and actual bowling, tennis and~     boxing {{ 295 Graves,L.E. 2008; 296 Graves,L. 2008; }} while others have explored the~     Nintendo Wii console for rehabilitation of an adolescent with cerebral palsy {{294~     Deutsch,J.E. 2008; }}.~      To the authors knowledge no studies have investigated the effect of 10 weeks of Nintendo Wii~     Fit balance training in seniors (+65 years). The main purpose of the study is to investigate~     the hypothesis: That 10 weeks of Nintendo Wii Fit balance training in a group of seniors (+65~     years of age) have a significant effect on postural balance and muscle strength.~   "
167648|NCT01371240|"~     Accurate preoperative tumor detection and staging are fundamental for treating patients with~     pancreatic adenocarcinoma. Patients with unresectable tumors can benefit from being spared an~     extensive operation associated with substantial morbidity and mortality, cost, and pain. On~     the other hand, patients with localized disease, which is amenable to surgical removal, have~     the option of operation. Therefore, accurate staging of pancreatic cancer requires the~     detection of the tumor, and evaluation of its size, its relationship to major peri-pancreatic~     vascular structures and portal venous system, locoregional lymph nodes, and distant~     metastases. Multiple imaging techniques have been used to evaluate the pancreas. Although, at~     this point, no consensus exists as to the best staging algorithm, multidetector (MD) computed~     tomogrophy (CT) and Magnetic resonance imaging (MRI) provide sufficient information for the~     management of most patients.~      Patients with a tumor larger than 3 cm are characterized as non-surgical. CT sensitivity in~     detecting small pancreatic tumors of less than 2 cm is low. Multiple methods have been~     suggested to increase the sensitivity of CT. The sensitivity of CT increases with using~     multidetector CT which now has an accuracy rate of about 95-97% for initial detection and~     approximating that of 100% for staging.~      Secretin (a natural hormone produced by the duodenal mucosal cells) is known to increase~     blood flow to the pancreas. The principal use of secretin in imaging today is in exocrine~     function of the pancreas or morphological evaluation of the pancreatic duct under ultrasound~     or MRI. Theoretically, pancreatic contrast enhancement should also increase after secretin~     administration. This would imply that tumor conspicuity might also be increased if contrast~     enhancement of the normal pancreas increases. Secretin CT has been advocated by other centers~     to improve depiction of the ampulla and periampullary/duodenal diseases and to improve~     contrast enhancement. O'Connell et al, used secretin in patients suspected or with known~     pancreatic mass and concluded that administration of intravenous secretin leads to greater~     enhancement of the pancreas with greater tumor conspicuity, than imaging without secretin.~      MRI of the pancreas has undergone a major change because it can provide noninvasive images of~     the pancreatic ducts and the parenchyma. MR cholangiopancreatography (MRCP) enables detection~     of anatomic variants such as pancreas divisum. Although contrast material-enhanced CT is~     still considered the gold standard in acute pancreatitis and for the detection of~     calcifications in chronic pancreatitis, MR imaging and secretin-enhanced MRCP are useful in~     evaluating pseudocysts and pancreatic disruption.~      The role of MR is still debated in pancreatic neoplasms except the cystic lesions where MR~     imaging provides critical information regarding the lesion's content and a possible~     communication with the pancreatic ducts. Although some articles have shown that MRI was~     equivalent to CT in diagnosis and staging, others have shown the opposite. Nishiharu et al.~     found comparable tumor detection but a benefit with CT, notably for peripancreatic and~     vascular invasion. Comparing CT, echoendoscopy, and MRI, Soriano et al. demonstrated that CT~     showed the highest level of precision in primary tumor staging, local-regional staging,~     vascular invasion, distant metastases, Tumor, node, metastasis (TNM) staging, and tumor~     resectability. MRI retains its originality in imaging the parenchyma, the pancreatic and~     biliary ducts, and vascular structures; however, in many institutions, CT remains the~     reference imaging choice for diagnosing and staging pancreatic cancer. Other than CT's~     advantages for the tumor, its excellent spatial resolution also provides detailed~     reconstructions in all planes and arterial mapping and therefore makes it possible to search~     for surgical contraindications such as celiac trunk stenosis. MRI is still used today as a~     second-intention tool when there is doubt or when CT and echoendoscopy are not sufficiently~     conclusive; it is not currently recommended to use MRI in first-intention diagnosis of~     pancreatic cancer.~      The aim of this pilot study is to determine whether the administration of intravenous~     secretin before contrast-enhanced CT and MRI improves pancreatic enhancement and pancreatic~     tumor conspicuity and to evaluate which technique is more appropriate for pancreatic tumor~     detection, staging and evaluation of resectability.~   "
167649|NCT01371227|"~     The purpose of this study is to evaluate tolerability of the combination therapy of JNS002~     and bortezomib in Japanese bortezomib-naive patients with multiple myeloma who have ever~     received at least 1 line of chemotherapy.~   "
167650|NCT01371214|"~     The primary goal of this study is to perform a 36-week pilot study with a cross-over design~     to study the safety and efficacy of a novel integrative exercise program called PLIÉ~     (Preventing Loss of Independence through Exercise). PLIÉ integrates elements of Eastern and~     Western exercise traditions and is specifically designed to target the muscles and movements~     needed to help individuals with mild-to-moderate dementia maintain physical function and~     independence.~   "
167651|NCT01371201|"~     The FIRSTMAPPP study is a randomized, double-blind, phase II, international, multicenter~     study which aims to determine the efficacy of Sunitinib on the progression-free survival at~     12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated~     with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).~   "
167652|NCT01371188|"~     Introduction: Non-mechanized sugar cane harvesting preceded by burning, an important and~     prevalent professional activity of agribusiness segment of the Brazilian economy, exposes~     workers and people of neighboring towns to high concentrations of pollutants and, therefore,~     potentially several risks to health hazards.~      Objectives: Assessing cardiopulmonary impacts and inflammatory markers in sugarcane workers~     and volunteers from a nearby town in non-harvest and harvest periods.~   "
167653|NCT01371175|"~     The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and~     recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.~      Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled~     at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of~     up to 10% (approximately 10 additional volunteers) will be permitted in the study.~   "
167654|NCT01371162|"~     This 2-part, randomized, double-blind, placebo-controlled study will assess the safety,~     pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with~     hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending~     doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).~   "
167655|NCT01371149|"~     To evaluate a novel advanced physiological monitoring system to improve nocturnal~     non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD),~     Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS)~     patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn,~     will improve ventilatory failure, quality of life and reduce length of admission during~     initiation of therapy. We aim to incorporate this technology into routine clinical practice.~   "
167656|NCT01371136|"~     Although a significant amount of work has been done to validate simulators as viable systems~     to teach technical skills outside the operating room, the next necessary step is to integrate~     simulator training into a comprehensive curriculum. The purpose of this study is to develop~     and validate a comprehensive ex-vivo curriculum for laparoscopic colorectal surgery. This~     curriculum will include training on a virtual reality simulator, cognitive training and~     cadaver lab training. The investigators will assess the effectiveness of the curriculum by~     conducting a randomized single blinded controlled trial. The investigators will be comparing~     the technical performance of curricular trained and non-trained residents in the operating~     room, during a procedure on a patient. The investigators hypothesize that surgical residents~     who participate in the curriculum will have superior technical proficiency and cognitive~     knowledge relating to performing laparoscopic colorectal surgery compared to conventionally~     trained residents.~   "
167657|NCT01371123|"~     The purpose of this study is to determine whether children on long-term parenteral nutrition~     (>6 weeks) have serum aluminum concentrations that are higher than children (aged and gender~     matched) that have never received parenteral nutrition.~   "
167685|NCT01370746|"~     In this study, doctors will observe how and when pediatric patients who have received a solid~     organ transplant take their prescribed medication, and determining if there are reasons that~     keep these patients from taking all of their medicine.~   "
170469|NCT01334099|"~     The purpose of this study is to determine the maximum dose of CP-675,206 when given in~     combination with radiation. Patients will be given local radiation to one tumor site and an~     intravenous infusion of CP-675,206.~   "
167658|NCT01371110|"~     Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a leading~     cause of worldwide disability that presents a significant public health problem. Treatment~     options are limited and many OCD patients fail to respond completely or quickly to standard~     treatments, including pharmacotherapy and psychotherapy. At this time, patients who fail to~     respond to treatment with serotonergic drugs, augmenting antipsychotic agents, and behavioral~     therapy, have few additional treatment options aside from deep brain stimulation. Therefore,~     despite advances in current pharmacological and behavioral treatments, and the utility of~     serotonergic drugs, it is likely that other neurotransmitter systems are involved and that~     targeting these systems may increase treatment efficacy. Despite little evidence for~     serotonergic dysfunction in OCD, there is significant evidence that glutamatergic~     dysregulation may contribute to the development and progression of the disorder. Also,~     preliminary studies suggest that glutamatergic modulators (i.e. riluzole and d-cycloserine),~     particularly agents acting at the NMDA receptor (i.e. memantine), may be useful in OCD. The~     NMDA antagonist, ketamine, has demonstrated rapid effects when delivered as a single~     intravenous (IV) dose in depressed patients. Therefore, the objective of the current study is~     to investigate the safety and efficacy of a single dose of IV ketamine in treatment-resistant~     OCD.~   "
167659|NCT01371097|"~     The aim of the study is to evaluate the effect of progressive resistance strength training~     (PRT) in elderly hospitalised patients. The hypothesis is that PRT given as an additional~     training would improve the rehabilitation and increase the level of activity of daily living.~   "
167660|NCT01371084|"~     The primary aim of this pilot study is to test the efficacy of a worksite intervention for~     reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g.,~     measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary,~     overweight, full-time working adults as compared to a waitlist control. A secondary aim will~     be to test pedal time at work as a measure of compliance with the intervention.~   "
167661|NCT01371071|"~     A majority of patients with multiple sclerosis initially presents with a single demyelinating~     event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to as a clinically~     isolated syndrome (CIS). Not all patients with CIS get a relapse and develop multiple~     sclerosis but in those patients who do, irreversible damage of the central nervous system,~     e.g. axonal damage, is already detectable in that early stage of disease. Early initiation of~     immunomodulatory therapy is crucial for patients with clinically isolated syndrome who are at~     high risk for the development of multiple sclerosis. Vice versa identification of low risk~     patients could help to avoid an unnecessary therapy. In this prospective observational study~     we want to follow up patients with CIS and early multiple sclerosis over a period of four~     years and obtain clinical, laboratory and MRI - data in order to identify risk factors for~     relapses, prognostic factors and therapy response markers.~   "
167662|NCT01371058|"~     Thrombotic event is one of the most serious complications of coronary artery disease, which~     often result in myocardial infarction and even death. Even according to the standard~     guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic~     events, in high-risk patients, the proportion is higher, this phenomenon is called~     anti-platelet drug resistance in clinical practice~      The aim of this multicenter prospective, randomized, controlled study is to observed~     policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after~     Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and~     short-term prognosis to find new ways to the prevention of platelet aggregation .~   "
167663|NCT01371045|"~     The purpose of this study is to test the effect of long-acting somatostatin analog~     medications, taken by patients with acromegaly or carcinoid syndrome, on growth hormone in~     comparison to healthy controls who are not receiving the medication in order to see whether~     or not the medication makes the oral glucose test less accurate. The Oral Glucose Tolerance~     Test (OGTT) is a standard test to measure growth hormone secretion. By comparing GH responses~     in non-acromegaly subjects taking somatostatin analog treatment, the relative contribution of~     the medication and the underlying disease state can be analyzed.~   "
167664|NCT01371032|"~     The purpose of this study is to compare:~      the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy~     during tracheal intubation to the VideoMiller device (the standard pediatric blade with a~     camera attached, giving indirect view of the vocal cords in the screen). This intubation~     device is used to place the tube in the trachea to keep the patient breathing during the~     surgery procedure.~      The anesthesiologist obtains a better view of the vocal cords looking at the screen provided~     by the VideoMiller.~   "
167665|NCT01371019|"~     The purpose of this study is to to collect and store blood samples that will be utilized to~     develop a multimarker test to predict preterm delivery.~   "
167666|NCT01371006|"~     Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when~     administered together.~      To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe~     , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.~   "
167667|NCT01370993|"~     The purpose of this study is to develop the hypoxemia prediction model during fiberoptic~     bronchoscopy under MAC(monitored anesthesia care) anesthesia.~   "
167668|NCT01370980|"~     The purpose of this study is to implement a support interdisciplinary program(oncologists,~     pharmacists, physicians, nurses, leagues against cancer) of medication adherence to oral~     oncology treatments. The aim is to ensure continuity of care between~     professionals,effectiveness of treatment and patient safety.~   "
167669|NCT01370967|"~     The purpose of this study is to assess stool consistency, in combination with additional~     health-related parameters including gastrointestinal tolerance and health-related quality of~     life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and~     reasons for changes in the choice of formula or method of feeding among infants in this~     sample, as well as incidence of common infant illness and associated healthcare usage.~     Anthropometric measures and the frequency and duration of physician- and parent-reported~     gastrointestinal and other adverse events will be evaluated.~   "
167702|NCT01370525|"~     This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of~     frequent heartburn~   "
170507|NCT01333605|"~     The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as~     salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.~   "
167671|NCT01370941|"~     An adequate calcium intake is important for bone turnover and the risk of developing~     osteoporosis. Yet many studies have documented that supplementation with calcium tablets are~     often associated with a poor compliance, therefore it is important to explore ways to better~     calcium influx.~      Calcium consumed through dairy products must first be cleaved from the molecules which it is~     bound to before it can be absorbed. Chymosin is an enzyme which cleaves the protein binding~     between some amino acids in κ-casein. The reaction occurs after ingestion of milk and causes~     a process whereby the time the milk is staying gastrointestinal tract is extended, this can~     lead to enhanced uptake of calcium.~      When the body's calcium balance is in equilibrium excretion in urine (24 h) in roughly the~     size of the intake, whereby a measurement of circadian urine excretion of calcium can~     determine the amount of calcium absorbed from the intestine.~      The investigators want to clarify whether the addition of chymosin to milk increases calcium~     absorption. Secondary to explore issues of significance for this effect, including vitamin D~     status and amount of daily calcium intake and whether a change in calcium absorption has~     immediate effects on bone turnover (measured as plasma osteocalcin, bone specific alkaline~     phosphatase (BSAP), and the renal excretion of cross-linked N-terminal telopeptide of type 1~     collagen (NTx/Cr) ratio) and on the parathyroid function (measured as PTH). Finally we will~     explore relations between bone mineral density (BMD) and the measured parameters (in terms of~     P-PTH, P-25OHD, P-1,25(OH)2D, P-osteocalcin, P-BSAP, and U-NTx/Cr).~   "
167672|NCT01370928|"~     The purpose of this study is to compare the performance of a new prototype colonoscope with a~     standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a~     smaller diameter than the standard colonoscope. The hypothesis to be tested is that the~     prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the~     patient. Both colonoscopes are manufactured by the same company.~   "
167673|NCT01370915|"~     Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in~     postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was~     to investigate the efficacy and safety of pregabalin for reducing postoperative pain in~     patients after septoplasty. Persons who scheduled for elective septoplasty under general~     anesthesia were randomly assigned to groups that received either pregabalin (150 mg twice) or~     placebo, one hour before surgery and 12 hours after the initial dose. Assessments of pain~     (verbal numerical rating scale) and side effects were performed at one, six, 12, and 24 hours~     postoperatively.~   "
167674|NCT01370902|"~     This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the~     safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug)~     and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated~     doses of NNC141-0100 in subjects with Rheumatoid Arthritis.~   "
167675|NCT01370889|"~     This pilot phase I trial studies resveratrol in postmenopausal women with high body mass~     index. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of~     resveratrol may keep cancer from forming. Studying samples of blood and urine in the~     laboratory from postmenopausal women who are taking resveratrol may help doctors learn more~     about the effects of resveratrol on biomarkers.~   "
167676|NCT01370876|"~     To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with~     recurrent or metastatic head and neck cancer and to assess the safety profile of these~     treatment regimen.~   "
167677|NCT01370863|"~     The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters~     of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal~     Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump~     inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability~     will be evaluated.~   "
167678|NCT01370850|"~     To perform a clinical validation study of RTVue features in volunteers with various ocular~     pathology or no ocular pathology.~   "
167679|NCT01370837|"~     Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in~     arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's~     disease can also be a consequence of polyneuropathy. Patients with Charcot's disease suddenly~     develop a red, warm and swollen foot, like an infection. Charcot's disease leads to foot~     fractures. After these fractures have healed, the shape of the foot can be dramatically~     altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves~     are important in regulating the inflammatory response. This study aims to investigate whether~     the inflammatory response is different in patients with polyneuropathy with and without a~     history of Charcot's disease.~   "
167680|NCT01370824|"~     Skin cancer is the most common cancer in Caucasians. Basal cell carcinoma (BCC) is the most~     frequent skin cancer with around 44.000 new tumours per year in the Netherlands, and its~     incidence is still rising. Prior to treatment, a punch biopsy (PB) is taken from the~     suspected lesion, in order to determine the subtype of BCC. There are three different~     histological subtypes of BCC, from least to most aggressive: superficial, nodular and~     aggressive. Based on the most aggressive subtype seen in the PB, a suitable surgical margin~     is chosen. Surgical excision (SE) is the treatment of first choice in all BCC subtypes~     according to the Dutch guidelines. Recent developments of non-invasive therapies for~     superficial BCC might be the first choice of treatment in the future. These non-invasive~     treatments (photodynamic therapy (PDT), Imiquimod and 5-fluorouracil (5-FU)) have better~     cosmetic results than SE and are therefore also used in the Maastricht University Medical~     Center. Drawback is a higher recurrence rate than SE. As nodular and aggressive subtypes grow~     deeper into the dermis, they have to be treated with SE with a 3 mm and 5 mm margin~     respectively. If BCC are located in the H-zone, the treatment will be Mohs micrographic~     surgery (MMS). Unfortunately, 30% of subtypes seen in the PB do not correspond with the~     subtype seen in the subsequent SE/MMS. The consequence is overtreatment and undertreatment. A~     potential better or equal way to determine the BCC subtype might be the clinical diagnosis.~     To our knowledge, there is no literature about the diagnostic value of the clinical diagnosis~     to determine the subtype of BCC seen in the SE/MMS specimen. We want to confirm the~     hypothesis that the clinical diagnosis is as good as, or even better than the histological~     diagnosis by PB to determine the BCC subtype in the subsequent SE/MMS. In this case, patients~     don't have to undergo an extra procedure, diagnostic route is shortened.~      - Primary objective: to establish the observed agreement of clinical diagnosis compared to~     histological diagnosis by to determine the most aggressive subtype of BCC~      - Secondary objectives: inter-observer and intra-observer variability of dermatologists and~     pathologists to determine subtype BCC.~   "
167681|NCT01370811|"~     The purpose of this study is to determine whether OC (oxybutynin and clonidine) oral solution~     is effective in reducing saliva secretion in patients suffering from Parkinson's Disease with~     excessive salivation.~   "
167703|NCT01370512|"~     The hypothesis is that pyridostigmine will improve the safety factor of ganglionic neural~     transmission, while Droxidopa will replete the postganglionic neuron of norepinephrine (NE).~     This combination should result in enhanced orthostatic release of NE. The investigators have~     already demonstrated that pyridostigmine does not raise supine blood pressure.~   "
167686|NCT01370733|"~     This study is designed to evaluate the safety and efficacy of synchronized transcranial~     magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects~     with Major Depressive Disorder. This is a multicenter study in which subjects will be~     randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of~     double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy~     or antidepressant medications during the follow-up phase of the study. Follow-up evaluation~     visits will be conducted during those four weeks, with the frequency of the visits determined~     by the treatment choice during that timeframe.~   "
167687|NCT01370720|"~     Despite the pathophysiology of IBS remains largely unsettled, several mechanisms have been~     proposed to explain symptom generation. These include psychosocial factors, altered~     gastrointestinal motor function and altered perception of visceral stimuli because of chronic~     low-grade inflammation and increased nociceptive mediator release by inflammatory cells,~     particularly mast cells.~      The aim of this pilot study is to provide evidence of:~        1. intestinal mast cell (MC) infiltration and activation in IBS patients;~        2. down-modulation of MC activation by the oral administration of the association of~          palmitoylethanolamide (PEA) and polydatin in IBS patients.~   "
167688|NCT01370707|"~     The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.~   "
167689|NCT01370694|"~     This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in~     combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single~     agent, for participants with B-lymphocyte antigen cluster of differentiation 20~     (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study~     hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a~     single agent.~   "
167690|NCT01370681|"~     The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose~     combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to~     healthy subjects.~   "
167691|NCT01370668|"~     Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of~     the population. Recent research point at the relevance and persistence of cognitive~     dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment~     has been classically associated with schizophrenia and not bipolar disorder. Current findings~     suggest that some intervention is needed in order to improve not only affective symptoms but~     also cognitive dysfunctions, so that patients could benefit from cognitive remediation~     techniques to improve cognitive impairment and the functional outcome. There is no previous~     research on the efficacy of cognitive remediation programs on bipolar disorder.~   "
167692|NCT01370655|"~     This study is being done to evaluate the antihypertensive efficacy and tolerability of~     MK-7145 in participants with mild-to-moderate hypertension.~      The primary hypotheses for the study were as follows:~        1. Multiple dose administration of 6-mg MK-7145 results in a reduction in systolic blood~          pressure (SBP) in male participants with mild to moderate hypertension that is superior~          to placebo, as measured by time weighted average change from baseline over 24 hours~          postdose (TWA0-24hrs) on dosing Day 28~        2. Multiple dose administration of 6-mg MK-7145 results in a reduction in SBP in male~          participants with mild to moderate hypertension that is similar to hydrochlorothiazide~          (HCTZ), as measured by TWA0-24hrs on dosing Day 28~        3. The effect of MK-7145 and HCTZ on natriuresis (UNaV) as well as SBP and diastolic blood~          pressure (DBP), both as measured by TWA0-24hrs, will be estimated~        4. Multiple dose administration of MK-7145 for 4 weeks will be generally safe and~          well-tolerated.~   "
167693|NCT01370642|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir~     given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus~     treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic~     hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of~     participants achieving sustained virologic response 24 weeks after completion of all study~     therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of~     participants achieving SVR24 in the control arm.~   "
167694|NCT01370629|"~     This non-interventional prospective study is a post-authorization safety study (PASS) of~     vernakalant conducted to collect information about normal conditions of use and appropriate~     dosing, and to quantify possible medically significant risks associated with the use of~     vernakalant in real-world clinical practice.~   "
167695|NCT01370616|"~     This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of~     moderate to severe diabetic foot infections. The primary hypothesis was that treatment with~     ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in~     achieving clinical improvement or cure.~   "
167696|NCT01370603|"~     The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg~     combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin~     40 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.~   "
167697|NCT01370590|"~     The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/20 mg~     combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin~     20 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.~   "
167698|NCT01370577|"~     The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly~   "
167699|NCT01370564|"~     This chronic, prospective, non-randomized feasibility study is designed to evaluate the~     Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic~     Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter~     Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers~     Management to Patients with Advanced Signs & Symptoms of Heart Failure (COMPASS-HF) Extension~     Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac filling~     pressures from the Chronicle device to provide timely medication adjustments (diuretics) to~     subjects.~   "
167700|NCT01370551|"~     The purpose of this study is to assess the longterm safety and efficacy of the vaginal~     application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on~     atrophic vaginitis in postmenopausal breast cancer patients who have been treated with~     aromatase inhibitors.~   "
167701|NCT01370538|"~     This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of~     frequent heartburn~   "
167705|NCT01370486|"~     Lennox-Gastaut syndrome is a severe epileptic encephalopathy of childhood. In that syndrome,~     various type of seizure occur, mainly tonic seizures, atonic seizures and atypical absences.~     The tonic seizure occur mostly at night.~      The hypothesis is that the melatonin could have a positive effect in that syndrome, by~     reducing the epileptic activity (assessed in the polysomnographic record by counting the~     number of interictal and ictal discharges) and stabilizing the structure of sleep.~      The study is double blind, randomised, cross-over designed.~   "
167706|NCT01370473|"~     The purpose of this study is to create an institutional and population-based registry of~     Hyponatremia with a prospective survey based on epidemiological data, risk factors,~     diagnosis, prognosis, treatment, monitoring and survival.~      This study will also describe the occurrence of hyponatremia in the population of HIBA in the~     Central Hospital, as well as the characteristics of clinical presentation, evolution and~     predisposing factors of hyponatremia.~   "
167707|NCT01370460|"~     This study aims to assess postoperative blood loss and transfusion rates in total knee~     replacement after one-time administration of topical tranexamic acid.~   "
167708|NCT01370447|"~     This study evaluates the safety and efficacy of EPI-743 in patients with severe mitochondrial~     respiratory chain diseases who are considered to be within 90 days of end-of-life care.~   "
167709|NCT01370434|"~     Based the proven efficacy and the ability to induce rapid response of various combinations of~     bortezomib including PAD combination in refractory and newly diagnosed patients with Multiple~     Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD combination~     (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the feasibility of~     harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of PAD.~   "
167710|NCT01370421|"~     This is an observational study (not a treatment study) of pain and physical functioning after~     total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery.~     You may be eligible if you are 50 or older,will soon be undergoing knee replacement surgery,~     do not have a serious heart condition or certain other medical conditions, and are not taking~     certain types of medications. The study includes evaluation of peoples' pain, physical~     functioning, medication use, and physiological responses to sensory stimuli such as heat and~     cold.~   "
167711|NCT01370408|"~     In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30~     minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy.~     On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be~     administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen~     is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be~     administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given~     orally for 2 days following chemotherapy.~   "
167712|NCT01370395|"~     Elderly patients are often admitted to hospital because of chest pain that is atypical for~     angina pectoris. In case of inconclusive electrocardiograms, determination of troponin is~     important for the diagnosis of an acute coronary syndrome. A highly sensitive assay for~     troponin T has recently been developed, permitting measurements of concentrations that are~     lower by a factor 10 than those measureable with conventional assays. In patients with stable~     coronary artery disease these concentrations were significantly associated with the incidence~     of cardiovascular death and heart failure but not with myocardial infarction. Copeptin, a~     novel biomarker of endogenous stress, may improve the diagnostic performance of troponin for~     an acute coronary syndrome in elderly patients. Other biomarkers such as~     MR-pro-adrenomedullin and endothelin-1 could improve both the diagnostic and prognostic~     assessment of the physician in these patients.~   "
167713|NCT01370382|"~     The planned cohort study shall clarify whether the use of biomarkers leads to improved~     diagnostic assessment of elderly patients. The study will evaluate the clinical value of~     biomarkers (highly sensitive Troponin T, Troponin T of the 4th generation) in elderly~     patients. These biomarkers are analyzed together with the symptoms and other parameters~     collected at admission. The diagnosis of myocardial infarction could be made earlier and more~     accurately with the help of biomarkers, in particular the highly sensitive troponin T.~   "
167714|NCT01370369|"~     This is an open-label study of a single and repeated application of three dose levels of~     topical testosterone in hypogonadal males with morning serum testosterone concentrations <~     297 ng/dL.~   "
167715|NCT01370356|"~     This study will determine whether varenicline is safe and helps people to quit smoking~     through reduction when they are not willing/able to make an abrupt quit attempt.~   "
167716|NCT01370343|"~     The primary purpose of this study is to evaluate the pharmacokinetics, safety and~     tolerability of a single dose of PF-04991532 in healthy adult subjects with and without~     co-administration of cyclosporine.~   "
167717|NCT01370330|"~     This is a compassionate use protocol to allow patients with advanced neuroblastoma palliative~     access to 131I-metaiodobenzylguanidine (131I-MIBG).~   "
167718|NCT01370317|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose~     treatment with MK-1029 in adults with mild to moderate persistent asthma.~   "
167719|NCT01370304|"~     The purpose of this study is to treat participants with a diagnosis of depressive disorder to~     assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in~     the treatment of depressive disorders compared venlafaxine only (the optimal medication) and~     to rTMS only. fMRI will be performed to determine if treatment response is related to changes~     in fMRI, and use it to investigate the respondence to the treatments.~   "
167720|NCT01370291|"~     The aim of the study is to evaluate the effects of repetitive transcranial magnetic~     stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings~   "
167721|NCT01370278|"~     The goal of this clinical research study is to compare the effects of sodium bicarbonate to~     normal saline when used for clearing mucus blockage in patients with airway stents.~   "
167832|NCT01368835|"~     The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment~     to obtain lift and tightening of the cheek tissue and improve jawline definition and~     submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a~     focused manner below the surface of the skin~   "
171464|NCT01321008|"~     The goal of this clinical research study is to learn if radiation therapy and chemotherapy~     can help control stage 1 and/or 2 NK cell lymphoma. The safety of radiation and chemotherapy~     will also be studied.~   "
167722|NCT01370265|"~     Blockage of the heart arteries (coronary artery disease) can lead to angina (chest pain),~     heart attacks, heart failure, and/or death. Positron emission tomography (PET) stress~     myocardial perfusion imaging (MPI) is a powerful tool to help identify blockages in the~     coronary arteries. During the PET MPI test, a drug is given to mimic the effects of exercise~     on the heart. The study was done to measure blood flow to the heart using two similar drugs~     approved to mimic the effects of exercise on the heart in people during a heart stress test.~     The first drug, called adenosine, has been approved for this use for several decades. The~     second drug, called regadenoson, was approved in 2008. The investigators were looking at~     whether the increase in blood flow to the heart with the newer drug (regadenoson) was similar~     to the increase in blood flow with the older drug (adenosine). This information is important~     for the use of these drugs in patients and for interpreting the blood flow values.~   "
167723|NCT01370252|"~     Post-operative pain will be measured using a pain diary for one week post-surgery. The~     purpose is to test the assumption that the arthroscopic technique leads to less~     post-operative pain and results in shorter hospital stays when compared to the open~     technique. It is believed that the arthroscopic technique will result in minimal pain when~     compared to the open technique, allowing this procedure to be performed as day surgery.~   "
167724|NCT01370239|"~     The humanized monoclonal antibody against Lewis Y antigen (Hu3S193) has been demonstrated to~     be safe in previous studies and has also been indicated as potential intervention in breast~     cancer. The study of this new agent in advanced breast cancer may contribute to the~     development of new strategies for patients that progressed after hormonal treatment.~   "
167725|NCT01370226|"~     The aims of the study are to develop and refine tailored motivational brief interventions~     that are parallel in structure but have varied delivery modalities (computer vs. therapist)~     for patients with at-risk or problematic alcohol use, and to conduct a randomized controlled~     trial comparing the efficacy of these BI approaches (CBI, TBI, control) on subsequent alcohol~     consumption and alcohol consequences, including alcohol-related injury, mental and~     physical-health functioning, and HIV risk behaviors at 3-, 6-, and 12-months post-ED visit.~   "
167726|NCT01370213|"~     This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative~     haploidentical transplantation for the treatment of high-risk acute myeloid diseases.~     Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early~     stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free~     neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28~     patients will be enrolled for a total of 43 patients. Patients will be followed for disease~     response for 2 years.~   "
167727|NCT01370200|"~     The investigators want to compare the efficacy of plasma exchange treatment with using two~     different citrates ( 4% and 15% ) as anticoagulants in plasma exchange treatment.~      The efficacy of plasma exchange treatment is better with using 15% trisodium citrate as~     anticoagulant during the plasma exchange procedure.~   "
167728|NCT01370187|"~     The aim of the current study is to evaluate the effect of Montelukast in treatment of acute~     bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age~     in Bandar Abbas Children' hospital.~   "
167729|NCT01370174|"~     Falls and their consequences are among the major problems in the medical care of older~     individuals. The long-term goal of this research is to establish the efficacy of a~     scientifically grounded and mechanism-based therapeutic intervention for improving balance~     function and preventing falls in older people. When human balance is challenged, protective~     stepping is a vital strategy for preventing a fall during activities of daily life. Many~     older people at risk for falls have particular difficulties with successfully stepping~     sideways as a protective response to loss of balance in the lateral direction. We propose~     that age-related declines in lateral balance function through impaired protective stepping~     that precipitates falls, result from neuromechanical (NM) limitations in hip~     abductor-adductor (AB-AD) muscle strength (torque and power). Moreover, we hypothesize that~     these functional and NM impairments are reversible with combined high intensity induced step~     training (IST) and muscle strengthening.~   "
167730|NCT01370161|"~     The purpose of this study is to determine whether early use of transjugular intrahepatic~     portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to~     prolong the survival in cirrhotic patients with high risk acute variceal bleeding.~   "
167731|NCT01370148|"~     The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour~     continuous infusion of conivaptan in subjects with severe liver impairment compared to~     subjects with normal liver function.~   "
167732|NCT01370135|"~     Proliferative ischemic retinopathies lead to a formation of abnormal vessels on the iris~     surface induced by an increased level of vascular endothelial growth factor (VEGF). In~     progressive stages fibrovascular membranes occlude the anterior chamber angle which inhibits~     aqueous outflow resulting in neovascular glaucoma. The increased intraocular pressure is~     often difficult to control and frequently results in loss of vision.~      The aim of this study is to analyze the short- and long-term outcome after adjuvant~     intraocular Ranibizumab application in patients with neovascular glaucoma and rubeosis and to~     analyze the role of ranibizumab within a holistic treatment regime.~   "
167733|NCT01370122|"~     Pelvic Floor dysfunction affects the quality of life of women. However, the prevalence and~     risk factors for pelvic floor disorders (PFD) in survivors of gynecologic malignancies are~     not known. The investigators plan to perform an observational study including survivors of~     gynecologic malignancies. Questionnaires for diagnosis of pelvic floor disorders will be~     mailed to survivors to generate prevalence rates and risk factors for PFD in women with a~     history of a gynecologic cancer diagnosis.~   "
167734|NCT01370109|"~     Tyrosine kinase inhibitors such as sunitinib are used in the treatment of renal cell~     carcinoma and have significant off-target effects with cardiac toxicity and resultant~     ventricular cardiac dysfunction being a major concern. However, the mechanisms of these~     effects in humans remains poorly defined, as are the clinical methods to risk stratify and~     identify patients who will ultimately suffer from cardiac dysfunction. The goal of this~     multi-center study is to characterize the cardiovascular measures of cardiac function; 2)~     comprehensive measures of arterial function and left ventricular afterload; 3) biomarkers~     reflective of the pathophysiologic alterations. Through this work, the investigators will~     translate our basic understanding of sunitinib cardiotoxicity to humans and identify early~     predictors of sunitinib cardiotoxicity.~   "
167735|NCT01370096|"~     To diagnose pulmonary hypertension, children have a cardiac catheterization to check the~     blood pressure in their lungs. Children with pulmonary hypertension have high blood pressure~     in their lungs. The right ventricle of the heart has to do more work to pump against this~     higher pressure. The investigators do not know the best medicine(s) to help children with~     pulmonary hypertension when their right ventricles fail. The purpose of the study is to look~     at the effects of two different medicines on the blood pressure in the lungs of a child with~     pulmonary hypertension. The investigators hope to then be able to choose the best medicine~     for children with pulmonary hypertension and right ventricular failure.~      The first medicine is called vasopressin. It is a hormone that your body makes on its own.~     The investigators will be giving it through an intravenous infusion. The investigators think~     that vasopressin works differently in different parts of your body. The investigators are~     looking to see the different effects that vasopressin has in the lungs compared to the rest~     of the body.~      The second medicine is called prostacyclin and is something that your body also makes by~     itself. Prostacyclin, given via an intravenous infusion, is a treatment for pulmonary~     hypertension as it decreases pressure in the blood vessels. In the catheterization~     laboratory, patients breathe in this medicine to measure specific changes in the blood~     pressure in their lungs.~   "
167736|NCT01370083|"~     People with swallowing impairment experience particular difficulty swallowing thin liquids~     safely; the fast flow of liquids makes them difficult to control. The tongue plays a critical~     role in containing liquids in the mouth, channeling the direction of their flow towards the~     pharynx (throat) and controlling their flow along that channel. The investigators are engaged~     in a program of research to better understand tongue function in swallowing, particularly~     with respect to controlling the flow of liquids. In this study the investigators will compare~     two different tongue-pressure resistance training protocols, to determine whether a protocol~     that emphasizes strength-and-accuracy or one that emphasizes pressure timing work better for~     improving liquid flow control in swallowing.~   "
167737|NCT01370070|"~     To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic~     nasopharyngeal carcinoma (NPC)~   "
167738|NCT01370057|"~     The purpose of this study is to compare the risk of curve progression in Adolescent~     Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.~   "
167739|NCT01370044|"~     The aim of this clinical trail is to evaluate the efficacy of a Carbogen inhalation in~     patients with febrile seizures compared to a placebo-inhalation.~      Further aims are the evaluation of the safety of the Carbogen inhalation via a low-pressure~     can with a breathing mask in a home-setting, the manageability of the Carbogen inhalation via~     a low pressure can with a breathing mask in a home-setting or on the way (mobility), the~     quality of life of the parents and children using the low pressure can with a breathing mask~     in a home-setting or on the way (mobility) and the contentment and anxiety of the parents.~   "
167740|NCT01370031|"~     The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung~     deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation~     of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™~     spacer device without or with charcoal block.~   "
167741|NCT01370018|"~     For more than 20 years, alpha-1-Proteinase Inhibitor therapy (Zemaira®) has been the standard~     treatment for patients who have too little alpha-1-Proteinase Inhibitor in blood. Adult~     patients with this condition eventually develop emphysema. Most HIV-1 patients who have low~     viral load also have too little alpha-1-Proteinase Inhibitor in blood. Recent strong evidence~     shows that the number of CD4 cells in blood goes up when alpha-1-Proteinase Inhibitor goes~     up. Patients were asked to participate in a pilot study to see whether the use of Zemaira®~     (alpha-1-Proteinase Inhibitor) would increase blood levels of alpha-1-Proteinase Inhibitor~     and consequently increase CD4 cells.~   "
167742|NCT01370005|"~     This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2~     diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and~     macrovascular complications, assessment of both glucose and blood pressure lowering effects~     of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly~     relevant, new information for the use of BI 10773~   "
167743|NCT01369992|"~     Cancers are among the most frequent leading causes of death in Taiwan, and many of them show~     their respective unique epidemiological and pathophysiological features in Taiwanese~     population. One of the distinguishing features of cancers includes their potential to~     metastasize outside the primary tumor. Pleural cavity and peritoneum are two of the most~     frequent sites of metastases when serosal surfaces are involved. The prognoses of such~     patients are extremely poor with a median survival of months. The understandings of cancer~     biology of tumor metastasis demand more in-depth studies at the molecular and cell levels.~     Studies based on cell culture are excellent approaches for this purpose as the cell culture~     provides a relevant and renewable model for studying the pathological and molecular changes~     underlying human malignant tumors.~   "
167744|NCT01369979|"~     The investigators wish to determine the lumped constant (LC), which is a correction factor~     necessary for converting measurements of hepatic FDG metabolism (measured by PET) to those of~     regular glucose in patients with cirrhosis and healthy subjects.~      Working hypothesis~        -  LC for FDG in liver tissue is not significantly different from unity in healthy subjects~        -  LC for FDG in liver disease is significantly different from LC in healthy liver~        -  Insulin changes the LC for FDG in liver tissue, but not by the same factor in liver~          disease and healthy subjects.~   "
167760|NCT01369771|"~     The objective of this study is to investigate corneal confocal microscopic findings, ocular~     signs and symptoms in patients on treatment with the preserved prostaglandin analogue~     latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free~     prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using~     latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion~     criteria including the specified ocular symptoms and signs, will switch from latanoprost~     0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve~     (12) months.~   "
167761|NCT01369758|"~     The objective of this study is to demonstrate the safety and effectiveness of community~     gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the~     MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.~   "
167745|NCT01369966|"~     Background:~      - Smoking is associated with serious health risks. People who have mental illness are more~     likely to smoke. Researchers are studying the brain circuits linked with smoking and nicotine~     craving. This study will look at whether a specific brain circuit can explain the high rate~     of smoking in people with schizophrenia.~      Objectives:~      - To study brain activity in smokers and nonsmokers with and without schizophrenia, as well~     as their family members.~      Eligibility:~        -  Current smokers (at least 100 cigarettes in the past year) and nonsmokers between 18 and~          62 years of age in one of the following groups:~        -  Have been diagnosed with schizophrenia.~        -  Family members of those with schizophrenia.~        -  Healthy adults with no history of severe mental illness or brain trauma.~        -  Family members of the healthy adults.~      Design:~        -  People in the study will be screened with a physical exam, medical history,~          questionnaires, and blood tests.~        -  They will have up to three visits: the screening visit and two study visits (each given~          1 year apart).~        -  At the first study visit, those taking part will be trained in the tests they will do~          during the magnetic resonance imaging (MRI) scan. Then they will have the MRI scan.~        -  After the first study visit, current smokers will receive phone calls from the study~          researchers every other month for 1 year. They will be asked about their smoking habits.~        -  At the second study visit, current smokers and some nonsmokers will have another MRI~          scan and the same tests as before.~        -  Current smokers will receive a final phone call 1 year after the second study visit.~          They will be asked to give information about their smoking habits.~   "
167746|NCT01369953|"~     Since 2007, the cost of sequencing a diploid human genome has fallen dramatically, from~     approximately $70 million to $20,000. As affordable sequencing platforms become more widely~     available, the advancement of biomedical science will draw increasingly on whole genome~     sequencing research requiring large cohorts of diverse populations. Key policy, ethical and~     legal implications of these developments will need to be understood in order to promote the~     efficacy and effectiveness of genomic research going forward.~      An overall aim of this project is to obtain feedback on the informed consent process from~     some of the earliest particpants in studies using whole genome sequencing. A more specific~     goal is to characterize the salient personal and public references accessed by participants~     around the time of the informed consent process. By highlighting trends in participants views~     about study participation around the time of the initial informed consent process, we aim to~     advance the development of an ethically and socially relevant vocabulary with which to~     negotiate future terms of use for personal sequence data in genomic research.~      Participants will be asked to complete a one-time, semi-structured telephone interview~     lasting approximately 45 minutes in the period 2-8 weeks following their initial informed~     consent session at the NIH. They will be recruited from two NIH protocols employing whole~     genome sequencing for distinct purposes. They The ClinSeqTM Study is a large-scale medical~     sequencing project investigating the causal role of genetics in cardiovascular disease~     enrolling both symptomatic and healthy individuals. The Whole Genome Medical Sequencing for~     Gene Discovery Study (WGMS) enrolls children and adults for full sequencing with the aim of~     discovering the genetic etiology of rare conditions.~   "
167747|NCT01369940|"~     Normal growth and development of twins are important for the long-term health of the~     children. The purpose of this study was to empirically define the trajectory of fetal growth~     in dichorionic twins using longitudinal two-dimensional ultrasonography and to compare the~     fetal growth trajectories for dichorionic twins with those based on a growth standard~     developed by our group for singletons. This knowledge may lead to interventions that could~     minimize or prevent pregnancy and newborn health problems in the future.~   "
167748|NCT01369927|"~     The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a~     saccharide-protein conjugate composed of a fragment of S. sonnei LPS. The saccharide~     component consists of an average of 3.5 repeat units of the O-SP plus the core region of the~     LPS (O-SPC). The O-SPC is covalently bound to the recombinant non-toxic exoprotein B of~     Clostridium difficile.~      The objective of this phase of the study is to determine if this vaccine is safe and can~     induce IgG antibody type-specific immunity to shigellosis in adults. The overall objective is~     to determine if this vaccine can elicit higher levels of IgG antibody than the previous~     experimental vaccines made with the full length O-SP, shown to be >70% efficacious in greater~     than or equal to3 year old children, to induce type-specific immunity to shigellosis in~     younger children.~      Sixty 18-49 years-old healthy adults will be recruited in Israel. Volunteers will be~     vaccinated on a random basis with one i.m. injection of 10 or 25 micrograms of the~     investigational conjugate vaccine. Local and systemic reactions will be observed at 30~     minutes, and the volunteers will be instructed to take their temperature and examine the~     injection site for redness and swelling and fill out a questionnaire at 6, hours and daily~     for 7 days after vaccination. The volunteers will visit the clinic at 24 or 48 hours~     following the injection and any time they request it. The study will commence with 5~     volunteers injected with the 10ug dose to be followed, if no severe adverse reactions occur,~     by 5 volunteers injected with the 25ug dose. If a severe adverse reaction occurs on 1 of the~     5 volunteers in either group, 5 more will be injected with that dose. If there are no severe~     adverse reactions the study will proceed. If there is one more severe reaction the study will~     be halted and re-evaluated by the IRB and the FDA.~      Vaccine-induced antibodies will be measured at 1 and 6 months after immunization, and~     compared to those elicited by our previous S. sonnei conjugate vaccines.~      There is a body of evidence that a critical level of serum IgG antibody to the O-specific~     polysaccharide domain of LPS confers type-specific immunity to S. sonnei as well as to other~     Shigella:~        1. Shigellosis is rarely observed in infants up to the age of 4-6 months. The most obvious~          explanation for this is that maternally-derived serum IgG provides this immunity;~        2. There is an age-related development of IgG anti-LPS antibodies that, in many instances,~          is not induced by the homologous bacteria but by non-pathogenic cross-reacting enteric~          bacteria;~        3. The highest incidence, morbidity, and mortality occur during 6 months to 6 years of age~          when the maternally-derived serum anti-O-SP has waned and the naturally-derived~          antibodies have not yet appeared;~        4. One injection of a S. sonnei-rEPA conjugate showed significant protection against~          shigellosis in Israeli Defense Force soldiers. Vaccinees who developed shigellosis~          showed significantly lower serum IgG responses to the homologous LPS than those did~          not.The high antibody level induced by the conjugate vaccine indicates the positive~          correlation between the serum IgG anti-LPS levels and immunity to S. sonnei infection;~        5. Following Phase 1 and Phase 2 studies that showed safety and age-related immunogenicity,~          a double-blinded randomized and vaccine-controlled Phase 3 evaluation of S. sonnei and~          S. flexneri type 2a O-specific polysaccharide (O-SP) protein conjugates was conducted~          among 1-4 year-olds in Israel.~      For recipients of the S. sonnei conjugate 71.1% efficacy was shown among 3-4 year-old~     recipients, no efficacy was shown for recipients of S. flexneri 2a. There was no~     statistically significant efficacy for either vaccine in the 1-3 year-olds. Levels of serum~     IgG anti-O-SP were elevated according to the vaccine the children received but G.M. levels~     declined rapidly several months after the last injection. Our interpretation is that the~     age-related efficacy of the Shigella conjugates was due to the conjugate-induced O-SP~     antibody levels. Accordingly, we have developed a method to increase the immunogenicity of~     the conjugates to approach the antibody levels of Israeli soldiers shown to be protected by~     our S. sonnei O-SP.~      Low-molecular-mass O-SP-core (O-SPC) fragments were isolated from S. sonnei LPS, and bound by~     their reducing ends to the carrier protein. The O-SPC conjugates used oxime linkages between~     the terminal Kdo residues at the reducing ends of the S. sonnei saccharides and aminooxy~     linkers bound to the carrier. The coupling reaction was carried out at a neutral pH and room~     temperature. The carrier protein was a mutant non-toxic Clostridium difficile exotoxin B. IgG~     antibody levels induced in young outbred mice by this new S. sonnei O-SPC conjugate were~     significantly higher than those elicited by the O-SP conjugates.~   "
167749|NCT01369914|"~     Background:~        -  Stem cell transplantation (SCT) is used to treat some kinds of cancer, blood cell~          disorders, and immune disorders. Stem cells from a donor s blood are used to replace the~          recipient s stem cells in the bone marrow. The recipient s bone marrow can then produce~          new blood cells. Some of these new cells involved in the immune system are like the~          donor s cells. Sometimes immune cells from the SCT attack the recipient s normal~          tissues, including the eyes. This type of immune attack is called graft-versus-host~          disease, or GVHD.~        -  The symptoms of ocular GVHD include eye pain, irritation, dryness, and inflammation.~          When it is severe and if it does not respond well to treatment, ocular GVHD may also~          cause vision loss.~      Objective:~      - To learn more about graft-versus-host disease (GVHD) of the eyes in people who have had~     stem cell transplantation.~      Eligibility:~        -  Participants must be at least 18 years of age.~        -  They must be taking part in a study at the National Cancer Institute (NCI) or the~          National Heart, Lung and Blood Institute (NHLBI).~        -  They must have a SCT scheduled within the next 30 days.~      Design:~        -  The study lasts for 1 year and includes six visits to the National Eye Institute. (There~          is an optional visit about 1 month before your SCT.) When possible, visits for this~          study will be scheduled so that they can be done on the same day as your visits for the~          NCI or NHLBI protocol that you are taking part in.~        -  At each visit, participants will have a medical exam and an eye history will be taken.~          They will have an eye exam and a test to measure the ability to make tears. Those in the~          study will also have tear fluid collected for analysis in a lab. Tear fluid collection~          is a painless process. Blood will be drawn during certain visits if it has not already~          been collected by the transplant team.~   "
167750|NCT01369901|"~     Background:~      -Spinal and bulbar muscular atrophy (SBMA) is an inherited disorder that affects men. People~     with SBMA often have weakness throughout the body, including the muscles they use for~     swallowing, breathing, and speaking. We do not know if exercise helps or harms people with~     SBMA.~      Objective:~      -To see if a 12-week program of either functional exercise or stretching exercises will~     improve strength, function, or quality of life in people with SBMA~      Eligibility:~        -  Participants will be men 18 years of age or older who have genetic confirmation of SBMA.~        -  They must be able to walk at least 50 feet with or without an assistive device such as a~          cane or a walker and stand for 10 minutes without using an assistive device.~        -  They must have access to a computer with an Internet connection.~      Design:~        -  At the first visit to NIH (2 days), participants will have a medical history taken and~          undergo a physical exam. They will also have blood tests and an EKG, and complete~          questionnaires about mood, health, and exercise. Tests of muscle strength, balance, and~          endurance will also be done.~        -  Participants who qualify for the study will receive instruction about either~          strengthening or stretching exercises. They will do these exercises at home one to three~          times a week for 12 weeks.~        -  They will wear a small activity monitor while they exercise and record their exercise in~          a diary.~        -  At the end of 12 weeks, participants will return to the NIH for 2 days. They will~          undergo the same tests as they had on the first visit.~        -  Participants will receive follow-up phone calls and e-mails during the study and for 4~          weeks after the last visit....~   "
167751|NCT01369888|"~     Background:~      - Researchers have developed an experimental cancer treatment called cell therapy. White~     blood cells called lymphocytes are taken from a tumor, grown in large numbers in the lab, and~     then given back to the patient. Interleukin-15, given to the patient after the cells (now~     called Young tumor-infiltrating lymphocytes of Young TIL cells) are replaced, helps the cells~     to grow and boosts the immune system. This process changes your normal cells into cells that~     are able to recognize your tumor has been studied in the lab. These cells can destroy tumor~     cells in the test tube, but scientists want to see if they work inside the body.~      Objectives:~      -To test the effectiveness of lymphocytes drawn from tumor cells combined with interleukin-15~     in treating metastatic melanoma.~      Eligibility:~        -  Patients must be 18 - 66 years of age and have a diagnosis of metastatic melanoma.~        -  They will have heart and lung function tests, lab tests, and imaging procedures.~        -  Patients may not have conditions such as active systemic infections, blood clotting~          disorders, or other active major medical illnesses.~        -  Patients may not be pregnant or nursing.~   "
167752|NCT01369875|"~     Background:~      - Tumor infiltrating lymphocytes (TIL) are white blood cells that have been taken from tumor~     tissue. The cells are modified to help them kill tumor cells, then given back to the person~     with cancer. By giving these cells to patients, researchers hope to improve the current~     treatments available for patients with melanoma that has not responded to standard therapies.~     The TIL will be given after treatments that will suppress the immune system. This makes it~     easier for the TIL to attack the cancer cells. The TIL will also be given with aldesleukin~     (IL-2), which is designed to help keep the TIL cells alive in the body.~      Objectives:~      - To study the safety and effectiveness of specially modified tumor infiltrating lymphocytes~     to treat melanoma that has not responded to other treatments.~      Eligibility:~      - Individuals at least 18 years of age who have metastatic melanoma that has not responded to~     other treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and imaging studies.~        -  A piece of tumor will be collected and white blood cells will be separated to make the~          TIL for the treatment.~        -  Participants will take drugs to suppress the immune system for 7 days before the start~          of treatment.~        -  Participants will receive the TIL in a single dose. Then they will receive IL-2 every 8~          hours for up to 15 doses. Participants will remain in the hospital for up to 2 weeks~          after treatment. They will be monitored with frequent blood tests and other studies.~        -  After leaving the hospital, participants will have regular followup visits every 1 to 4~          months for the first year. Then they will return for followup every 3 to 4 months, as~          directed by the study researchers.~   "
167753|NCT01369862|"~     The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose~     of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza~     virus infection. It is also performed to assess immunogenicity and pharmacokinetics~     (shedding).~   "
167754|NCT01369849|"~     This phase I/II trial studies the side effects and best dose of v-akt murine thymoma viral~     oncogene homolog 1 (Akt) inhibitor MK2206 when given together with bendamustine hydrochloride~     and rituximab and to see how well they work in treating patients with refractory chronic~     lymphocytic leukemia or small lymphocytic lymphoma. Akt inhibitor MK2206 may stop the growth~     of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as rituximab, can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     carry cancer-killing substances to them. Giving Akt inhibitor MK2206 with bendamustine~     hydrochloride and rituximab may be an effective treatment for relapsed chronic lymphocytic~     leukemia or small lymphocytic lymphoma.~   "
167755|NCT01369836|"~     The purpose of this study is the following:~        -  To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered~          tafamidis in Japanese and Western healthy volunteers at single dose.~        -  To compare Japanese and Western PK profiles.~        -  Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a~          validated ex vivo assay.~   "
167756|NCT01369823|"~     The purpose of this study is to examine whether pump treatment combined with the use of~     continuous glucose monitoring system is a mena to normalize glycaemic control.~   "
167757|NCT01369810|"~     To investigate how a switch from fixed combination treatment (ICS and LABA) to other~     treatments influence asthma or COPD treatment failure~   "
167758|NCT01369797|"~     Background :~      The evolving concept of frailty was born in the United States under the term of  frail~     elderly . It allows describing geriatrics situations, dominated by the weakness or the~     functional instability of aged person, illustrating situations at risk. It is about an~     effective concept, especially in the field of the prevention where it determines strategies~     of specific care. The ageing, changing according to individuals, is characterized by a~     decrease of the physiological reserves leading to a precarious balance and to a~     destabilization.~      Epidemiological studies show a very uneven distribution of three categories of old persons~     according to their health status. Every year, approximately, 12 % of the independent~     population of 75 years of age and older and living at home, lose their autonomy for one of~     the activities of the daily life and turn into frailty.~      Identifying frailty of old subjects is interesting in order to apply preventive and specific~     care strategies to reduce the risks of decompensation. The Global Geriatric Assessment (GGA)~     is the gold standard to detect frailty in this population. The beneficial effects of the GGA~     during the hospitalization have been recognized in international literature.~      The ageing heterogeneousness complexity and the high time-consuming character of GGA led to a~     difficult approach for the nurses or family practioners in taking care of old persons at~     home.~      To balance these difficulties and to optimize prevention of dependence in the elderly, an~     experimental unit of prevention was created : Unit for Prevention, Monitoring and Analysis of~     Aging (UPSAV) on January 4th, 2010 within the geriatric department of the Hospital University~     of Limoges. It is an innovative organizational structure because, for the first time, the~     geriatric expertise is proposed freely to the elderly at home. A multidisciplinary~     gerontological team consisting in a geriatrician, a nurse, a psychomotor therapist and an~     occupational therapist, can, on requiry, move at old persons' home to make a preventive GGA~     to detect the risks of loss of autonomy and to propose a coordination of preventive actions.~      Purpose :~      UPSAV's endpoints are to prevent frail elderly persons from the risk of autonomy loss. This~     action is led in partnership with all the professionals working around old persons.~      The randomized study endpoint is to evaluate elderly from 75 years of age and older at home~     and to select two homogeneous groups: reference and  specific intervention .~   "
167759|NCT01369784|"~     The purpose of this study is to evaluate the prognostic value of clinical and biological~     factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.~   "
167762|NCT01369745|"~     Thus study will test an experimental drug called Z-102 (combination of prednisolone and~     dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.~   "
167763|NCT01369732|"~     During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and~     reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the~     lower extremities and successive reperfusion results in injury to remote organs, including~     kidneys. So, there has been considerable interest in the development of therapeutic~     strategies aimed at attenuating IR injury. One such group of agents that are attracting~     interest due to their potential protective effects on vascular endothelium is the~     erythropoietin.~      However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not~     been fully clarified. Therefore, the purpose of this study is to determine whether the~     prophylactic administration of erythropoietin reduce the incidence of acute kidney injury~     (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The~     investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min~     before the commencement of ischemia. The differences between the control and study groups are~     observed by clinical indicators such as serum creatinine, TNF-α, NGAL.~   "
167764|NCT01369719|"~     Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral~     iron chelators reduce iron overload in transfusion dependent patients. The aim of this study~     is to compare the efficacy and safety of osveral and desferal in transfusional iron overload~     patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.~   "
167765|NCT01369706|"~     Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are~     restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest~     EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part~     of security screening processes in e.g. airport controls.~      The objective was to determine the safety of screening procedures for ferrous materials with~     regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.~   "
167766|NCT01369693|"~     In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users~     will be given repeated doses of four different types of portion snus: General, Catch,~     Catch Mini and Catch Dry Mini. Each portion of used snus will be collected and frozen~     (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific~     nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation~     of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco~     specific nitrosamines (TSNAs) respectively, will be done for each type of snus.~   "
167767|NCT01369680|"~     The study is a maximum tolerated dose finding study for oral, chronic, daily administration~     of oral ketamine (by mouth) in children with long-term daily pain.~   "
167768|NCT01369667|"~     The purpose of this study is to determine whether vitamin D supplementation is effective in~     the prevention of relapse in Crohn's disease.~   "
167769|NCT01369654|"~     The investigators propose to conduct formative research to gain an understanding of patients'~     needs and desires regarding elective Bilateral Salpingo-Oophorectomy (BSO) decision making,~     and to develop and pilot test a BSO Decision Support Guide, in preparation for a randomized,~     controlled trial of the effect of this decision aid on decision quality and use of BSO. The~     proposed study will consist of 3 phases. In phase 1, the investigators plan to conduct focus~     groups among women who have had a hysterectomy with or without bilateral~     salpingo-oophorectomy (BSO) to gain an understanding of what they understood about BSO and~     its possible outcomes at the time of their hysterectomy and what they would have liked to~     have known, the extent and manner in which they were included in decision making regarding~     BSO, and how they feel about the decision now. The investigators also will collect~     qualitative data from women who are scheduled for hysterectomy and currently facing the~     decision whether or not to undergo elective BSO. In phase 2, the investigators plan to create~     a BSO Decision Support Guide using information obtained from the literature, from our~     formative research, and the experience of providers who have counseled women about this~     choice. In phase 3, the investigators plan to pilot test the BSO Decision Support Guide among~     women scheduled to undergo hysterectomy for benign conditions to assess its usefulness and~     usability for patients and their providers and to prepare for a randomized study of its~     impact on decision quality and use of BSO. 62 women who are scheduled to undergo hysterectomy~     for a non-cancerous uterine condition will participate in the pilot study. These women will~     participate in a baseline interview, during which they will be provided access to the BSO~     Decision Support Guide, and 2 follow up telephone interviews (one as they are making their~     final BSO decision and a second after they have undergone and recovered from their~     hysterectomy (with or without BSO). Data will be used to generate the final version of the~     Decision Support Guide, to finalize evaluation measures for future studies of the~     effectiveness of the guide, and to determine effect sizes for the outcomes of knowledge, BSO~     use, decision satisfaction and decisional conflict.~   "
167770|NCT01369641|"~     This is a pilot, randomized, self-controlled study of the effects of intratympanic sodium~     thiosulfate (STS) on the degree of hearing loss in patients receiving cisplatin therapy.~     Sodium thiosulfate is an inactive ingredient contained in sulfacetamide ophthalmic solution~     which is used routinely as an otic solution delivered to the middle ear space.~      The hypothesis of this study is that local administration of sodium thiosulfate (STS) will~     result in improved hearing compared to ears not receiving the study drug in patients~     receiving systemic cisplatin therapy.~   "
167771|NCT01369628|"~     The sponsor electively terminated the study because the risk mitigation measures, deemed~     necessary after an unforeseen safety event, could not be effectively implemented within this~     protocol while maintaining study timelines within a reasonable time frame.~   "
167772|NCT01369615|"~     The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride~     (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17~     years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid~     therapy who completed the 4 -week treatment period in OTR3001.~   "
167773|NCT01369602|"~     The primary purpose of this study is to evaluate the pharmacokinetics, safety and~     tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.~   "
167774|NCT01369589|"~     The primary objective of this clinical study is to determine the impact of P-552 oral rinse~     on salivary volume after administration of a single dose of P-552and versus vehicle rinse.~     Changes in oral mucosal wetness will be assessed via collection of salivary output and via~     measurement of oral wetness using the Periotron 8000 instrument.~   "
167788|NCT01369407|"~     REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory~     patients with chronic, advanced, systolic heart failure that will provide a greater~     understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD~     use and death), and of how baseline clinical risk measures are related to prognosis.~   "
167789|NCT01369394|"~     The goal of this study is to determine whether a computer-based intervention that delivers~     individually-tailored educational messages about the MMR vaccine increases MMR~     vaccine-hesitant parents' intentions to have their children vaccinated.~   "
167845|NCT01368666|"~     The primary objective of this clinical investigation is to assess the safety and~     effectiveness of the Perceval S valve at 12 months after implantation when used to replace a~     diseased or dysfunctional aortic valve or aortic valve prosthesis.~   "
167775|NCT01369576|"~     The clinical population targeted will be newly diagnosed patients with polysomnographically~     diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia.~     Outpatients who are also judged to be capable to follow the study procedures (consent,~     timelines, visits, questionnaires) and who do not have any concurrent disease that in the~     view of the investigator will interfere with participation in the trial to completion will be~     included. Approximately 160 subjects were recruited (80 per treatment arm) in the recent~     trial of eszopiclone. This size is expected to be able to discern an important difference of~     80 minutes per night. In the current clinical population newly prescribed CPAP at Mount Sinai~     Hospital, the average compliance after 4 weeks of initiation of nCPAP was 4:01 (SD 2:59)~     hours per night. To be able to discern a difference of at least 1 hour (60 minutes) in usage~     per night, including entirely non-adherent patients who do not use treatment at all as 'zero~     hour' users, would require randomization of 264 patients (132 per group).~      Our hypothesis for this study is that initial titration of CPAP treatment of OSA may be~     improved by initial prescription of a common hypnotic, zopiclone. To answer this question we~     intend to recruit 264 consecutive consenting subjects with OSA confirmed by a physician (ABSM~     or by a respirologist with extensive sleep medicine experience) with supportive~     polysomnography results who are willing to initiate long-term CPAP treatment.~   "
167776|NCT01369563|"~     To assess the efficacy, safety and tolerability of ciclesonide 200 mcg once daily, applied as~     a nasal spray for four weeks. The main outcome will be the improvement on global and~     individual typical and associated symptoms of intermittent or persistent rhinitis.~   "
167777|NCT01369550|"~     The purpose of this clinical trial is to evaluate whether the omega-3 fatty acid stearidonic~     acid (SDA), when used as a food ingredient, increases the level of the long-chain omega-3~     fatty acid eicosapentaenoic acid (EPA) in red blood cell (RBC) membranes in men and women.~   "
167778|NCT01369537|"~     Two hundred million adults worldwide have major surgery every year. A million of these~     patients will have an obvious stroke after their surgery. Another 10 million patients may~     have silent strokes. Although silent strokes are not diagnosed immediately, they are likely~     to reduce patients' short-term memory, concentration, and ability to function at home.~     However, the investigators do not know how common silent strokes are after noncardiac~     surgery, nor the extent to which they affect brain function.~      The investigators will first perform a pilot trial to determine the feasibility of the larger~     study that will provide the definitive answer to this question. Participating patients will~     be assessed by questionnaire before and after surgery, and will have a magnetic resonance~     imaging (MRI) study of the brain after the surgery to look for silent strokes. Combining the~     results of the MRI and the questionnaires will allow us to determine the frequency of silent~     strokes after non-cardiac surgery, and their effect on brain function. The NeuroVISION Pilot~     Study will determine the feasibility of a large study to examine the frequency and the impact~     of silent stroke in patients who undergo noncardiac surgery.~   "
167779|NCT01369524|"~     Although the investigators take many measurements to monitor the fluid state of the patients,~     it is not known exactly whether the fluid has real effect on the organ perfusion. The main~     focus of fluid is to improve the organ perfusion. Recent research has focused on the~     investigation of sublingual microcirculatory alterations.~   "
167780|NCT01369511|"~     The primary objective of this study is to test the hypothesis that appendicular lean body~     mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older~     participants undergoing elective total hip arthroplasty (eTHA).~   "
167781|NCT01369498|"~     This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow~     fibrosis either alone or in combination with ruxolitinib in participants with Primary~     myelofibrosis (PMF) and Post Polycythemia Vera or Post Essential Thrombocythemia~     Myelofibrosis (ET/PV MF).~      The study is designed as a two stage trial. In the stage 1, patients will be randomized into~     two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, patients on~     ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.~   "
167782|NCT01369485|"~     The purpose of this study is to evaluate the change from baseline between the active and sham~     treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).~   "
167783|NCT01369472|"~     This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg,~     64mg, 128mg in healthy male volunteers.~   "
167784|NCT01369459|"~     The goal of this project is to develop and test a brief protocol designed to systematically~     integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD)~     into behavioral treatment services for adolescent substance users with co-morbid ADHD in~     everyday care. Primary study aims will yield proof-of-concept data on MIP feasibility and~     fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services~     utilization, medication acceptance and compliance, and satisfaction with treatment services.~   "
167785|NCT01369446|"~     The purpose of this study is to demonstrate that the Eeva System may be used to identify~     embryos on Day 2 that are most likely to form blastocysts.~   "
167786|NCT01369433|"~     Open-label, multi-center, multi-national rollover study to allow continued access to~     tivozanib for subjects who have participated in other tivozanib (monotherapy or combination)~     protocols. Eligible subjects will continue to receive tivozanib at the same dose and schedule~     as per the original (parent) protocol. The length of time that a subject must be on the~     parent protocol before rolling over to this protocol will be dictated by the (original)~     parent protocol. Subjects will be seen by the investigator every 4 weeks (± 5 days). Adverse~     events and blood pressure will be recorded. At the beginning of Cycle 1 and at the beginning~     of every odd-numbered cycle (Cycle 3, Cycle 5, etc), clinical laboratory values will be~     recorded. CT scans to assess disease will be performed at the end of even-numbered cycles~     (Cycle 2, Cycle 4, etc).~   "
167787|NCT01369420|"~     The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low~     Energy Direct Current (LEDC) System when used to treat unresectable pancreatic~     adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including~     serious adverse events, laboratory data, physician exam findings, and vital signs.~   "
167913|NCT01367782|"~     The purpose of this study is to test the effects of low frequency deep rTMS using the novel~     H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's~     disease (PD), to establish its safety in this population and to test effects of maintenance~     treatments.~   "
167790|NCT01369381|"~     Current methods for endotracheal intubation in the presence of cervical spine (c-spine)~     instability are not evidence-based. This is so because the relationships between the forces~     applied during intubation (by the laryngoscope) and the resulting c-spine movement have not~     yet been quantitatively characterized. As a result, with the current level of knowledge, it~     is not known, and it is not possible to predict, which types of c-spine instability have the~     greatest risk of cervical spinal cord injury with intubation. This shortcoming makes it~     impossible to know which intubation devices and techniques are likely to be safest in the~     presence of c-spine instability.~      To address this critical lack of knowledge, the overarching purpose of the proposed research~     is to: 1) quantitatively relate c-spine movement that results from the forces applied to the~     peri-airway tissues during intubation (force-motion relationships), and 2) use these data to~     develop a mathematical model of the c-spine that will predict which types of c-spine~     instability result in the greatest amount of abnormal c-spine motion and associated spinal~     cord compression during intubation.~      This clinical study will utilize laryngoscope blades that are instrumented with a high~     resolution pressure mapping system to make high-resolution measurements of the forces and~     pressures of intubation while making simultaneous measurements of c-spine motion. In this~     study, study subjects will be intubated using both a conventional (Macintosh) laryngoscope~     and an alternative (Airtraq) laryngoscope. By using two different laryngoscopes, we, the~     investigators, will introduce forces of differing magnitudes and distributions to peri-airway~     tissues. The Airtraq does not require a direct line of sight to visualize the vocal cords,~     and among the various new alternative laryngoscopes it is the only one that has been shown to~     result in 30-50% less cervical motion than a conventional (Macintosh) laryngoscope.~     Accordingly, we hypothesize 1) 30-50% less force will be applied with the Airtraq~     laryngoscope than with the conventional (Macintosh) laryngoscope and 2) 30-50% less c-spine~     motion will occur with the Airtraq. By studying (intubating) each subject twice, any~     differences in the c-spine force-motion relationships between devices will be due to the~     devices themselves. By studying each subject twice, we can account for (and eliminate)~     differences among study subjects in c-spine biomechanical properties.~   "
167791|NCT01369368|"~     Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis~     is that a combination therapy can stabilize the disease for patients with early relapse after~     allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg~     daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans~     retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle.~     Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day~     10 is allowed from the second cycle.~   "
167792|NCT01369355|"~     The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance~     regimens of ustekinumab administered subcutaneously to patients with moderately to severely~     active Crohn's disease who responded to treatment with intravenous ustekinumab in studies~     CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.~   "
167793|NCT01369342|"~     This study (UNITI-2) will compare the effects (both positive and negative) of an initial~     treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely~     active Crohn's disease.~   "
167794|NCT01369329|"~     This study (UNITI-1) will compare the effects (both positive and negative) of an initial~     treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely~     active Crohn's disease who have either failed or could not tolerate at least one~     TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab~     pegol).~   "
167795|NCT01369316|"~     That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at~     least as safe but more effective than conventional EMR for injection assisted EMR of large~     laterally spreading tumour and sessile polyps of the colon.~   "
167796|NCT01369303|"~     The purpose of the study is to obtain data on the pharmacokinetics (PK) and pharmacodynamics~     (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing~     regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex~     acts.~   "
167797|NCT01369290|"~     Current methods of choosing treatment for major depressive disorder (MDD) are inefficient.~     The Strategic Treatment to Achieve Remission of Depression (STAR*D) Trial revealed that only~     about 1/3 of patients treated with antidepressant drugs will go into remission with the first~     medication chosen. We hypothesize that pattern recognition software using Machine Learning~     methods can accurately predict response to a variety of antidepressant medications (ADM) or~     cognitive behavior therapy (CBT) after training using pre-treatment demographic, clinical,~     laboratory or electroencephalographic (EEG) data. These algorithms might assist the clinician~     to chose, for any given patient, an antidepressant treatment option with greater probability~     of favourable response than is achievable using current best practise methods.~   "
167798|NCT01369277|"~     This study is to investigate the safety, tolerability and pharmacokinetics of single~     ascending oral doses of PF-04991532 in Japanese healthy subjects. The secondary objective is~     to investigate the pharmacokinetics and safety of single ascending oral doses of PF-04991532~     in Western healthy subjects and to compare the pharmacokinetics between Japanese and Western~     healthy subjects.~   "
167799|NCT01369264|"~     The proposed study is designed to determine whether small changes in the positioning of a~     transcranial magnetic stimulation coil over the frontal parts of the brain cause different~     patterns of brain activation measured by electroencephalography (EEG) and quantitative EEG~     (QEEG).~   "
167800|NCT01369251|"~     The purpose of this study is to determinate whether in newborns just cleaning the umbilical~     stump when changing diapers (with water and soap if necessary)is effective in preventing~     local cord infections and not delaying cord separation as just as cord care alcohol, usually~     applied in our hospital and suggested to parents at dismission.~   "
167801|NCT01369238|"~     1. Purpose of study~             1. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom~               Acupuncture Therapy on Whiplash-Associated Disorders using VAS scale~             2. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom~               Acupuncture Therapy on Whiplash-Associated Disorders using NDI, BDI, SF-36, and~               EQ-5D.~        2. Interventions & Groups~             1. group 1: Bee-Venom Acupuncture Therapy~             2. group 2: zaltoprofen~             3. group 3: Bee-Venom Acupuncture Therapy & zaltoprofen~   "
167802|NCT01369225|"~     This is a study to evaluate the safety and tolerability of multiple doses of AAB-003~     (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete~     study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each~     patient's participation will last approximately 52 weeks.~   "
167803|NCT01369212|"~     This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks~     followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir~     alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome~     will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained~     off-treatment response).~   "
167952|NCT01367275|"~     The goal of this clinical research study is to learn if adding brivanib to irinotecan can~     help control the disease in patients with colorectal cancer that has spread. The safety of~     this drug combination will also be studied.~   "
167807|NCT01369160|"~     The research proposed is a pilot study of pediatric and adolescent/young adult patients who~     have received the curative intervention (MSD-SCT), disease-modifying interventions (HU or CT)~     or SCC (control), with respect to three clinically important outcomes: quality-of-life (QOL),~     neurocognitive function, and reproductive potential. Comparable cohorts will be identified~     for each of the groups, drawing from patients treated by the SCD program of Children's~     Healthcare of Atlanta (CHOA). QOL measures and neuropsychiatric testing and will be~     administered. Reproductive endocrine function markers (laboratory studies and pubertal~     staging), will be collected and analyzed. A tracking system of such patients will also be~     developed, gathering available retrospective data and setting up a mechanism for collection~     of new data.~   "
167808|NCT01369147|"~     The investigators have designed this pilot, single-center Randomized Clinical Trial (RCT) to~     prospectively compare, for the first time, the clinical efficacy of different energy doses in~     ICU patients requiring PN due to intestinal failure/dysfunction. A total of 60 patients will~     be studied (20 per energy dose group) to generate critical preliminary data needed to inform~     subsequent appropriately powered Phase III multicenter trials.~      The primary aim of this study is to perform a controlled, double-blind, prospective,~     randomized, intent-to-treat Phase II clinical trial to test the efficacy of three specific~     energy doses [0.6, 1.0 and 1.3 x measured REE (resting energy expenditure), respectively],~     given for 28 consecutive days during the ICU and post-ICU course, on 28-day total~     hospital-acquired infections (primary endpoint), Blood Stream Infections ( BSI), and other~     important clinical outcomes in medical/surgical ICU patients requiring specialized parenteral~     ± enteral feeding. The investigators would also determine, in these subjects A) the impact of~     cumulative and mean daily 28-day energy deficits [energy intake-measured REE] on clinical~     outcome endpoints; and B) the practical utility of estimated REE determined by~     Harris-Benedict equation versus measured REE across different energy doses. The investigators~     would also like to determine the impact of administered energy dose and energy deficits on~     global metabolomic patterns over time and their association with key clinical outcomes.~   "
167809|NCT01369134|"~     Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and~     dentin is as effective as a one-step etch and rinse approach.~   "
167810|NCT01369121|"~     This study is being conducted to evaluate the safety and tolerability of Xerecept® in~     children with central nervous system tumors and to identify appropriate doses of Xerecept® to~     be used in subsequent pediatric clinical trials.~   "
167811|NCT01369108|"~     Study hypothesis: a new, low polymerization stress flowable composite performs no differently~     to a conventional, highly filled composite filling material when used as a restorative in~     small cavities in back teeth.~      Study will evaluate the clinical performance of a low shrinking flowable composite filling~     material, compared with a conventional, highly filled composite restorative when used to~     permanently fill small cavities in molar and premolar teeth in adult patients.~   "
167812|NCT01369095|"~     The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared~     with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant~     depression (TRD).~   "
167813|NCT01369082|"~     The purpose of this study is to provide patients who have received at least one islet~     transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT)~     clinical trial with maintenance immunosuppressive medications and to collect information~     about the safety of the medications and islet function.~   "
167814|NCT01369069|"~     The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized,~     controlled clinical trial of 1400 patients that will include approximately 60 enrolling~     sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke~     patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in~     improved 3 month outcome after stroke.~      Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and~     glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will~     include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites~     from all over the United States. The study will evaluate the safety and efficacy of targeted~     glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control~     therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The~     primary outcome will be functional outcome at 3 months as measured by the modified Rankin~     Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40~     mg/dL. Enrollment will occur over 3.5 - 4 years.~   "
167815|NCT01369056|"~     The general objective of this study is to evaluate HAART adherence in Estonia and the factors~     affecting adherence; and the impact of an individual adherence enhancement counselling and~     treatment monitoring model (Advanced Adherence, AdvAdh), compared to the regular counselling~     received by HAART patients.~   "
167816|NCT01369043|"~     Moderate exercise is thought to be one of the best known means to improve how insulin works~     in people. Taking vitamin C and vitamin E is also thought to have the same effect. This study~     is being done to see if taking vitamin C and vitamin E improves or hinders how insulin works~     when people do not exercise and when they do exercise.~   "
167817|NCT01369030|"~     This study will be an observational study in which patients who have been prescribed Deplin®~     are invited to participate in surveys regarding their experiences with Deplin®. The purpose~     of this study is to increase the understanding of the role of L-methylfolate among patients~     who are candidates for Deplin®, provide patients with personalized education and support, and~     contribute to the overall understanding of the needs and concerns of patients being treated~     for depression.~   "
167818|NCT01369017|"~     The investigators want to see if healthy people who are given 2 doses of a medication called~     anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then~     exposed to a form of air pollution, called Endotoxin, have less inflammation with the~     medication. Endotoxin is believed to be one of the causes of asthma attacks.~   "
167846|NCT01368653|"~     This clinical trials tests whether a new treatment designed to help smokers prepare to quit~     smoking by practicing quitting several times helps more smokers quit and stay quit than~     standard treatment with nicotine patch and smoking cessation counseling. The practice~     quitting treatment being tested involves quitting for progressively longer periods of time~     tailored to individual patterns of smoking. This clinical trial will also test whether~     non-nicotine cigarettes can help smokers become smoke free after slipping during a stop~     smoking attempt.~   "
167819|NCT01369004|"~     The purpose of this research project is to assess the efficacy of a weight loss intervention~     for chronic disease prevention that focuses on daily self-weighing as the primary~     self-monitoring strategy compared to a delayed-intervention control group. While daily~     self-weighing has been shown to be effective for weight loss in observational research, there~     is limited experimental evidence testing this association and most is derived from intensive~     interventions that may overshadow the effects of self-weighing. To mitigate this, the~     investigators will examine whether daily self-weighing is effective for weight loss under~     self-directed conditions using a randomized-controlled design.~      The investigators will conduct a 6-month randomized trial in 88 overweight and obese adults~     to compare a daily self-weighing intervention to a delayed-intervention control group.~     Changes in weight, diet and physical activity, and psychosocial measures will be examined.~      Main Study Hypothesis: Participants in the group randomized to receive the daily~     self-weighing intervention will have greater percent weight loss at 6 months compared to~     those in the delayed control group.~      Secondary Hypothesis: Participants in the group receiving the daily self-weighing~     intervention will report greater engagement in diet and physical activity behaviors that~     produce caloric deficits, greater self-efficacy and motivation, and no differences in body~     satisfaction, disordered eating, or depressive symptoms compared to those in the control~     group.~   "
167820|NCT01368991|"~     Kryptonite is a non-toxic biologic polymer, that has previously been used in orthopedic~     surgery. The objective of our study is to demonstrate the benefits of Kryptonite in cardiac~     surgery patients at high risk for sternal wound complications. The investigators have~     designed a randomized clinical trial of 48 high risk patients, with a 1:2 randomization of~     kryptonite to conventional closure. The primary outcome will be quality of life. Secondary~     outcomes include sternal complications, pain, hospital length of stay, and respiratory~     function.~   "
167821|NCT01368978|"~     This study is a prospective, single-center, open label, randomized; two-arms cross over~     study.~      This is the test protocol for the InsuPatch device, whose purpose is to improve insulin~     delivery into the blood when the insulin is infused using an insulin-infusion pump by~     controlled heating of the area surrounding the point of infusion.~   "
167822|NCT01368965|"~     This prospective, multi-center, single treatment clinical trial evaluates the clinical~     outcomes associated with non-invasive treatment to obtain lift and tightening of facial~     tissue and improve jawline definition in subjects with darker skin color utilizing the~     Ulthera® System to deliver focused ultrasound energy below the skin surface.~   "
167823|NCT01368952|"~     Efficacy of Pure Prone Positioning (PPP) treatment in improving apnea-hypopnea index (AHI)~     and nocturnal oxygen saturation was investigated in mild to moderate Obstructive Sleep Apnea.~   "
167824|NCT01368939|"~     This research protocol is designed to evaluate a novel imaging camera, only one of three of~     it's kind in existence, in the diagnosis of breast cancer. The Molecular Breast Imaging~     Camera (MBI) is a gamma camera that images accumulation of 99mTc-Sestamibi, a~     radiopharmaceutical with high affinity for tissues of high cellularity and mitochondrial~     content; a common characteristic of breast cancers.~      This camera represents a significant advancement over its predecessors as it has improved~     imaging geometry since it can be in direct contact with breast tissue and improved gamma~     photon detection capability through the use of cadmium zinc telluride (CZT) crystals (a~     semiconductor material) instead of NaI used in standard gamma cameras.~      This project involves imaging patients with a baseline population risk of breast cancer,~     referred for myocardial perfusion imaging (MPI). This is possible because 99mTc-sestamibi is~     also used to image myocardial tissue. After the MPI study is performed to standard clinical~     specifications, the patient is simply imaged with the MBI.~      The primary endpoint of this project is to assess acceptability of this imaging device by the~     patient through the use of a patient survey. Secondary endpoints are to correlate any~     findings on the MBI studies with standard breast imaging modalities including mammogram,~     ultrasound, and MRI. Image quality will be evaluated by the interpreting physicians. Also, in~     an effort to reduce radiation absorbed dose to the female breast, low injected dose images,~     obtained through post-processing by reframing acquired images, will be assessed for~     acceptable image quality and diagnostic accuracy.~   "
167825|NCT01368926|"~     This double-blind, randomized, placebo-controlled, 2-Part study will evaluate the~     pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In~     Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either~     RO4917523 or placebo, with a washout period of 21 days between dosing. In Part 2, healthy~     Japanese and Caucasian volunteers will be randomized in cohorts to receive either RO4917523~     or placebo orally daily for 14 days.~   "
167826|NCT01368913|"~     Desmopressin in treatment of nocturnal enuresis (bedwetting).~   "
167827|NCT01368900|"~     The purpose of this prospective, multi-center, single treatment study is to evaluate the~     clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the~     eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of~     the skin.~   "
167828|NCT01368887|"~     The purpose of this study is to test the effectiveness of DermiPsor's DPS-102 (test product)~     in patients with scalp Psoroasis. The study is also intended to assess the safety of the~     product.~   "
167829|NCT01368874|"~     This prospective, multi-center, single treatment clinical trial evaluates the clinical~     outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and~     neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner~     below the surface of the skin.~   "
167830|NCT01368861|"~     The purpose of this study is to observe and measure the analgesic effectiveness of the 5 S's~     (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with~     sucrose, during routine immunizations at 2 and 4 month well child visits.~   "
167831|NCT01368848|"~     Despite recent advances in the treatment of NSCLC overall survival within these patients~     remains dismal and there is yet an unmet medical need for additional treatment options. In~     this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and~     bevacizumab) is tested to determine the objective response rate in patients with unresectable~     and advanced non-small cell lung cancer. This response rate will be compared with historical~     data.~   "
167864|NCT01368419|"~     This study is to explore the clinical efficacy of continuous Endostar infusion combined with~     radiotherapy in esophageal cancer patients.~   "
167833|NCT01368822|"~     Several studies have shown that renal function in patients who have donated a kidney (but are~     otherwise healthy) remains stable and within normal limits. However, it is unclear how donor~     nephrectomy affects patient subsets with comorbidities, an issue that becomes relevant in the~     current environment where inclusion criteria are continuously becoming less stringent and~     more patients are being considered as potential donors.~      In the present study, the investigators plan to evaluate long-term renal function in obese~     patients who have donated a kidney as part of a living donor renal transplant procedure. The~     investigators have selected this group because it is at higher risk for developing~     obesity-related complications such as diabetes and hypertension that may impair renal~     function, it is rapidly becoming a major subgroup in the kidney donor population, and no~     studies have systematically followed obese patients after kidney donation. Establishment of~     an appropriate control group is of primary importance in studies examining long-term~     outcomes. The investigators will also evaluate a 2-kidney control group to allow us to~     compare the individual and interactive effects of obesity and kidney donation on long-term~     renal function. Study participants will complete a medical questionnaire, undergo blood~     pressure measurements, and provide blood and urine samples for analysis of various metabolic~     parameters. Some study participants will have ambulatory blood pressure monitoring performed~     which involves application of an automated blood pressure cuff for 24 hours. Some study~     participants will also undergo direct measurements of glomerular filtration rate (GFR) with~     iohexol.~      In the proposed research, the investigators hypothesize that obesity in kidney donors~     increases the likelihood of developing renal dysfunction and risk factors for cardiovascular~     disease (CVD) and may increase the likelihood even more than in healthy controls.~   "
167834|NCT01368809|"~     The purpose of this research is to evaluate the effectiveness of fentanyl for reducing~     coughing during the perioperative period (i.e., insertion of an LMA [Laryngeal Mask Airway]~     device, maintenance period during surgery, and awakening [emergence] from general anesthesia)~     for ambulatory surgery procedures. Also to assess the effects of fentanyl on the~     postoperative outcomes, (e.g., pain, postoperative nausea and vomiting, return of bowel~     function [constipation], resumption of normal activities of daily living).~      Fentanyl is one of the most common used anesthetic adjuncts for ambulatory surgery because of~     its anesthetic-sparing effects and alleged ability to reduce coughing during instrumentation~     of the patient's airway.~   "
167835|NCT01368796|"~     Based on information from several years of looking at Influenza vaccination doctors know~     that:~        -  Older adults suffer the worst illness and most deaths caused by Influenza illness of all~          age groups.~        -  Older adults do not seem to get as good a level of protection as younger adults after~          getting the usual seasonal Influenza vaccine.~      Because of this information doctors wonder if one of the new seasonal Influenza vaccines is~     more effective or more acceptable.~      This study has been designed to answer some of these questions. On this study doctors will~     compare 2 new vaccines against the usual seasonal influenza vaccine for protectiveness using~     several different testing methods (including the usual tests) and for acceptability.~   "
167836|NCT01368783|"~     Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in~     Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with~     tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to~     investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and~     Caucasian volunteers and compare the ethnic differences.~   "
167837|NCT01368770|"~     The use of coronary computed tomographic angiography(CTA)is rapidly increasing, but there is~     lack of data which supports their use in the initial evaluation of patients who are~     asymptomatic or mildly symptomatic. The hypothesis underlying this proposal is that the use~     of stress-rest myocardial perfusion imaging (MPI) as an initial test for the evaluation of~     asymptomatic or mildly symptomatic patients who are at intermediate risk of coronary events~     will result in less further non-invasive and invasive testing and result in reduced costs,~     without adversely affecting clinical outcomes in the short term.~   "
167838|NCT01368757|"~     In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide~     in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started~     once an optimal dose has been found. The primary endpoint will concern the efficacy of~     lenalidomide in patients with CMML according to the WHO diagnostic criteria.~   "
167839|NCT01368744|"~     The study will determine the sensitivity, specificity, negative predictive value and positive~     predictive value of the OSNA Breast Cancer System by comparing its performance to an~     extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during~     standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.~   "
167840|NCT01368731|"~     The hypothesis of this study is that prophylactic coagulation therapy with coagulation~     forceps to visible vessels within the mucosal defect for colonic Endoscopic Mucosal Resection~     (EMR) will reduce the rate of delayed bleeding when compared with current established~     standard EMR technique.~   "
167841|NCT01368718|"~     Chronic fatigue (CF) and chronic fatigue syndrome (CFS) are disabling disorders that may be~     induced or aggravated by underlying sleep disturbances. The relationship between sleep~     quality and fatigue is still not fully elucidated. To evaluate the effect of improved sleep~     quality on fatigue, a randomized controlled and cross-over trial with nasal continuous~     positive airway pressure (nCPAP) is carried out in patients who present with a primary~     complaint of chronic disabling fatigue and who are found to have an apnea-hypopnea index~     (AHI) >= 15 on polysomnography (PSG).~      The aim of this study is to address the issue of Continuous Positive Airway~     Pressure-responsiveness regarding fatigue as a presenting symptom in CF and CFS patient with~     obstructive sleep apnea (OSA), in the absence of underlying medical or psychiatric illness.~     The answer to this question may shed further light on the enigmatic relationship between~     sleep and fatigue. We also want to investigate the Continuous Positive Airway Pressure~     responsiveness regarding sleepiness and general health in the same target population.~     Zero-hypothesis: there is no effect.~   "
167842|NCT01368705|"~     The objective is to the amount of protein infants require after cardiopulmonary bypass~     surgery.~   "
167843|NCT01368692|"~     The purpose of this study is to determine whether the shoulder retraction by placing a saline~     bag between the scapula influences a success rate of subclavian vein catheterization.~   "
167844|NCT01368679|"~     This is a prospective multicenter observational study with 20 patients to evaluate the~     performance of SCITECH stent for treatment of AAA. Will be enrolled the patient demographics,~     laboratory tests, medical history, clinical evaluation, physical examination, adverse events.~      The benefits and risks of the study should be explained before any specific test or procedure~     of the study. The written consent must be obtained from the patient. No action specifies the~     study should be performed while the patient has not signed the form of consent.~   "
167953|NCT01367262|"~     An open-label study being conducted to determine the metabolism and physiological disposition~     of radiolabeled LY2886721 after a single dose in healthy male subjects.~   "
167847|NCT01368640|"~     Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM~     based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and~     measurement data of the BIA devices on the other hand. The equations are necessary to use the~     device as a Body Composition Analyzer with an acceptable accuracy level for clinical~     practice.~   "
167848|NCT01368627|"~     E-SERIES Registry evaluate the procedural and clinical outcomes of the Supralimus® SES in the~     treatment of unselected, high risk patients having coronary Artery blockage in the real world~     clinical practice.~   "
167849|NCT01368614|"~     The purpose of this study is to evaluate the feasibility of using of the Average Volume~     Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP)~     and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed~     with Obesity Hypoventilation syndrome.~      The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will~     yield daytime gas exchange values which are equivalent or no worse when compared to using~     CPAP and bilevel PSV modes of ventilation in the OHS population.~   "
167850|NCT01368601|"~     This is a randomized placebo-controlled trial studying the effects of intraoperative~     continuous airway pressure (CPAP) on the inflammatory response of the lung with cancer~     undergoing lobectomy.~   "
167851|NCT01368588|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation~     therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy~     x-rays to kill tumor cells.~      PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation~     therapy in treating patients with prostate cancer.~   "
167852|NCT01368575|"~     The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate~     and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact~     on heart failure and progress of mitral regurgitation.~   "
167853|NCT01368562|"~     This is an open label compassionate use study of subcutaneously administered MNTX in subjects~     with advance medical illness and opioid-induced constipation. Eligible subjects were to~     initially receive a single dose of MNTX delivered SC. Subsequent dosing could have been~     adjusted upward to achieve a desired clinical response or lowered to alleviate drug related~     adverse events (AEs).~   "
167854|NCT01368549|"~     This study will be an observational study in which patients who have been prescribed Metanx®~     are invited to participate in surveys regarding their experiences with Metanx®. The purpose~     of this study is to increase the understanding of the role of Metanx® in managing diabetic~     neuropathy, provide patients with personalized education and support, and contribute to the~     overall understanding of the needs and concerns of patients being treated for diabetic~     neuropathy.~   "
167855|NCT01368536|"~     This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and~     chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and~     diabetes mellitus 2.~   "
167856|NCT01368523|"~     The purpose of this study is to provide patients with imatinib resistant/intolerant chronic~     myeloid leukemia - in blast crisis, accelerated phase and chronic phase, who have been~     previously enrolled to CAMN107A2109 and benefit from the treatment, with access to nilotinib~     (AMN107) in Poland until such time as the treatment with this drug is financed by the~     National Health Found in Poland (via 'therapeutic program') or for a period of 18 months,~     whichever comes first.~   "
167857|NCT01368510|"~     Even with the best available treatments for obsessive-compulsive disorder (OCD), most~     patients only partially recover and many patients do not respond at all. Such incomplete and~     inadequate response contributes to greater public health costs in terms of morbidity and~     patient care expenses. This study aims for a better understanding of abnormal brain chemistry~     in OCD and how it is affected by cognitive-behavioral therapy (CBT) in order to develop novel~     therapies and improve the success of existing therapies. The main hypothesis is that CBT will~     change levels of the excitatory neurotransmitter glutamate in OCD patients in a region of the~     brain involved in OCD known as the cingulate cortex.~   "
167858|NCT01368497|"~     The purpose of this study is to determine the safety and efficacy of treatment using a~     combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old~     with immunotolerant chronic hepatitis B.~   "
167859|NCT01368484|"~     The aim of this study is evaluated the effect of dietetic supplementation with DHA on human~     sperm quality, antioxidant capacity and sperm DNA damage.~   "
167860|NCT01368471|"~     The goal of this study is to demonstrate the superiority of the MGuard™ stent over~     commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better~     myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation~     myocardial infarction (STEMI).~   "
167861|NCT01368458|"~     This is a 12-week, with a 32-week follow-up, rater-blind, randomized controlled trial to~     determine whether patients with chronic schizophrenia or schizoaffective disorder receiving~     two different antipsychotics simultaneously will have any significant change in~     psychopathology following conversion to antipsychotic monotherapy. Additionally, the effects~     of conversion to antipsychotic monotherapy will be assessed by neurocognitive tests.~      The study will be conducted at the Clinical Research and Evaluation Facility (CREF), a~     specialized research unit jointly operated by the Nathan S Kline Institute for Psychiatric~     Research (NKI) and Rockland Psychiatric Center (RPC). Patients will be recruited from the~     regular in-patient units of RPC and transferred to the CREF. Following baseline assessments,~     patients will be randomized to continued antipsychotic polypharmacy treatment or to~     systematic conversion to monotherapy.~      Conversion to antipsychotic monotherapy will be assessed across multiple domains of~     psychopathology using the Positive and Negative Symptom Scale (PANSS). The primary outcome~     measure is PANSS total score. The secondary outcome measure is time on medication (all-cause~     dropouts). Mixed Model Repeated Measures (MMRM) will test the hypothesis that conversion to~     antipsychotic monotherapy will show minimal change from the control group.~   "
167862|NCT01368445|"~     The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine~     hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice~     daily in patients with seasonal allergic rhinitis.~   "
167863|NCT01368432|"~     This research is being done to see if a drug called escitalopram (Lexapro) is helpful to~     people who are suffering from depression after traumatic brain injury (TBI).~   "
167866|NCT01368393|"~     Background:~      Colonoscopy is often regarded as a painful and unpleasant procedure. Electroacupuncture (EA)~     has been used successfully to treat pain of various origins, but few good-quality studies~     have evaluated its role in treating pain and anxiety during colonoscopy.~      Objective:~      To investigate the efficacy of EA in reducing procedure-related pain and the consumption of~     sedatives/analgesics during colonoscopy.~      Design:~      Prospective, randomized, double-blind, sham-controlled study.~      Subjects:~      One hundred and twenty eight consecutive patients undergoing first-time elective day-case~     colonoscopy without previous experience of acupuncture will be recruited.~      Interventions:~      Patients will be randomized to receive either 45 minutes of EA or sham acupuncture (SA)~     before colonoscopy. The acupoints relevant to the treatment of abdominal pain, including~     Zusanli, Hegu, and Neiguan will be used. For the SA group, blunt-tip needles will be placed~     (without skin penetration) 15 mm away from the acupoints. Foam blocks will be used to~     stabilize the needles and to blind the patients and endoscopists to the treatment allocation.~     EA and SA will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil,~     delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both~     groups.~      Outcome measures:~      Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes:~     pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time,~     and episodes of hypotension/desaturation.~   "
167867|NCT01368380|"~     This study evaluates the effect of a psychological intervention to breast cancer patients and~     their partners compared to a control group receiving usual care~   "
167868|NCT01368367|"~     The purpose of this study is to determine whether a high intensity aerobic and resisted~     exercise program will improve physical, functional and psychological outcomes in patients~     post burn injury.~   "
167869|NCT01368354|"~     Summary Diseases due to T. solium and soil transmitted helminths (STHs) are of cosmopolitan~     distribution and strongly linked with poor sanitation and poverty. These infections are to a~     great extent perpetuated by open defecation (OD). Community-Led Total Sanitation (CLTS) is an~     approach in which people in rural communities are facilitated to do their own appraisal and~     analysis, come to their own conclusions, and take their own actions. To date no rigorous~     study has been conducted to evaluate the impact of CLTS on the transmission of~     taeniasis/cysticercosis or STHs, despite the worldwide acclaim which CLTS has received as an~     approach to improve sanitation. The overall aim of the study is to contribute to the~     reduction and subsequent control of T. solium and STH infections through the implementation~     of CLTS approaches in 1 districts in the Eastern Province of Zambia. By using CLTS it is~     hypothesised that toilet acquisition and usage will be increased with a resultant reduction~     in OD which will in turn reduce the transmission of T. solium and STH infections in the~     district. This will be measured by porcine/human cysticercosis prevalence (serological test)~     and STH infections in humans (quantitative coprological test).~   "
167870|NCT01368341|"~     Tick borne diseases are increasing in Norway. Lyme borreliosis is the most common infection.~     Erythema migrans is mainly diagnosed and treated in general practice. There is disagreement~     about what antibiotic treatment that should be given. An RCT with the three most common~     antibiotics used, will support data for revision of national guidelines.~   "
167871|NCT01368328|"~     The role of micronutrients in diabetes is not well understood. Studies have demonstrated the~     relationship between low chromium serum levels and insulin resistance. This study aims to~     evaluate the effect of chromium nicotinate on increasing insulin sensitivity in patients with~     type 2 diabetes.~   "
167872|NCT01368315|"~     A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327~     in the Atopy Patch Test model.~   "
167873|NCT01368302|"~     Patients with Post Traumatic Stress Disorder (PTSD) will be randomly assigned to either~     Attention Bias Modification Treatment (ABMT) designed to normalize threat-related attention~     biases or a placebo control condition not designed to change attention patterns. Outcome~     measures will be Post Traumatic Stress Disorder (PTSD), depression, and anxiety symptoms as~     measured by gold standard questionnaires and symptom counts derived from structured clinical~     interviews.~      We expect to see significant Post Traumatic Stress Disorder symptom reduction in the~     Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in~     which no symptomatic relief is expected.~   "
167874|NCT01368289|"~     A prospective, multicentre, observational study of all patients referred for endoscopic~     resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat~     analysis.~   "
167875|NCT01368276|"~     The purpose of this study is to learn about the safety and the risks of using talimogene~     laherparepvec in patients who already received treatment with talimogene laherparepvec in~     study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec~     can destroy melanoma tumors.~   "
167876|NCT01368263|"~     This phase II trial studies the impact of a presurgical endocrine therapy, consisting of~     goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage~     II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2~     (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body.~     E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth.~     Giving goserelin together with letrozole or anastrozole before surgery may enhance the~     effectiveness of, or eliminate the need for, chemotherapy~   "
167877|NCT01368250|"~     Aortic valve stenosis represents the clinically most important valvular heart disease in the~     elderly patient population. For several decades, surgical aortic valve replacement has been~     considered the standard in the treatment of symptomatic patients with aortic stenosis.~     Patients deemed at excessive-risk for conventional aortic valve replacement were treated~     conservatively with a very poor prognosis. In the search for less invasive treatment options~     for this elderly patient population, transcatheter aortic valve implantation (TAVI) was~     introduced in 2002 and since then has been established as an alternative, less invasive~     treatment option for non-operable or high-risk patients for conventional surgery. The purpose~     of this prospective multi-center, observational national registry in Switzerland is to obtain~     clinical baseline, procedural and follow-up data of all patients treated with TAVI in~     Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved~     devices. All centers in Switzerland implanting the CE approved devices for TAVI will be~     invited to include patients in the registry. Each site will collect baseline and procedural~     data as well as clinical outcome data up to five years.~   "
167878|NCT01368237|"~     Recent advances in technology have resulted in the development of scanners that can image the~     heart blood vessels within 10 to 20 minutes but without the need for admission to hospital or~     insertion of catheters. Further advances in technology allow the visualisation of both the~     blood vessels and the supply of blood to the heart muscle. Here we propose to assess the~     latest and most powerful computed tomography scanner and compare it to magnetic resonance and~     conventional coronary angiography.~   "
167879|NCT01368224|"~     In recent decades, the incidence of subjects presenting reactive skin has considerably~     increased in industrialized countries. Probiotics are live microorganisms which, when~     ingested in sufficient amounts, have beneficial effects on human health. The mechanism~     underlying the effect of probiotics involves, in part, regulation of the composition and/or~     metabolic activity of the intestinal microbiota.. It is postulated that following interaction~     of probiotics with the intestinal epithelium, associated intestinal cells become activated~     and consequently mediators are released into the blood circulation. Mediators, activated~     intestinal epithelial cells and possibly bacterial fractions might reach the skin through the~     bloodstream where they potentially could exert effects.The objective of this study was to~     assess the effects of probiotics on reactive skin symptoms. The strain Lactobacillus~     paracasei NCC2461 was tested alone and in combination with the strain Bifidobacterium longum~     NCC3001 in a randomized, double-blind study. The two strains were selected for their~     immune-modulatory properties demonstrated in in vitro and other preclinical studies as well~     as in a pilot clinical trial.~      Ninety-six women presenting reactive skin were randomized to 3 groups: placebo (n = 32), L.~     paracasei NCC2461 alone (n = 32) and L. paracasei NCC2461 + B. longum NCC3001 (n = 32). The~     supplements were administered by the oral route for 58 days (1010 CFU/day).~      The objective of the clinical trial was to determine, in vivo, the effect of food supplements~     on reactive skin symptoms (as measured by skin sensitivity and the reconstruction of barrier~     function post-repeated tape stripping).~      The secondary objectives were to determine the effect of the food supplements on leg skin~     dryness and facial skin roughness and the associated biochemical, immunological and~     microbiological factors.~      Accordingly, the subjects' skin sensitivity was determined by the capsaicin test. The~     reconstruction of barrier function was determined by measuring the trans-epidermal water loss~     (TEWL) post-repeated stripping using a SERVOMED evaporimeter. A clinical score for skin~     dryness and roughness was assigned by a dermatologist. The subjects also assessed their leg~     and facial skin dryness themselves. Each analysis was conducted at the various time points.~      In parallel, assessment of the skin moisturizing factors and serum inflammatory and~     immune-regulatory cytokines were performed. Finally, key components of the intestinal~     microbiota were analyzed.~   "
167880|NCT01368211|"~     The PRESS trial is a single-center, two-part, randomized cross-over pilot study in Copenhagen~     that will evaluate 1) the safety and performance of Mirasol-treated and untreated platelet~     products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and 2) the~     correlation between the TEG® parameters and platelet count increments after platelet~     transfusions in thrombocytopenic subjects.~   "
167881|NCT01368198|"~     The primary objective of this investigation will be to quantify the increase in tear film~     break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular~     Emulsion in dry eye sufferers.~   "
167882|NCT01368185|"~     This was a retrospective, chart review, observational study to assess the effect of MK-0954A~     (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period~     of at least three months on serum uric acid levels.~   "
167883|NCT01368172|"~     The first evidence-based physical activity guidelines for people with spinal cord injury were~     released in March, 2011. This project will evaluate the implementation of the new physical~     activity guidelines in a community exercise setting in Hamilton, Ontario. The investigators~     hypothesize that persons who follow the guidelines will experience increased aerobic fitness~     and muscle strength. The investigators also hypothesize that participants will find the~     guidelines easy to follow and that their self-efficacy for participating in physical activity~     will be improved following the study period.~   "
167884|NCT01368159|"~     The trial objectives are to compare efficacy relative to pain, along the route of the vein~     following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous~     vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg)~     versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be~     the comparison between the first two groups mentioned. All other contrasts will be secondary.~     The Class I compression versus The two class III compressions contrast will also be~     studied.~      Efficacy will be measured by totalling the VAS scores for maximum pain experienced since the~     morning and evaluated by the patient at the end of the day.~      Consumption of analgesics or the number of days of analgesic treatment necessary for the 3~     compression types used will be compared.~      One of the trial objectives is also to show that regular use of a class III compression~     product leads to a reduction in complications following sclerosis (by reducing the number of~     non-serious/serious complications specific to sclerosis: matting, pigmentation, inflammation,~     development of sclerosis requiring drainage, DVT, pulmonary embolism, etc.). The trial also~     aims to compare the rate of successful sclerosis between the three devices, success being~     defined by complete or partial occlusion of the great saphenous vein, leading to the~     disappearance of reflux at the crural level.~      The other secondary objectives will be patient evaluation of comfort, ease of putting on and~     taking off the compression hose and a global appreciation of the procedure for echoguided~     endovenous injection of sclerotherapeutic foam into the great saphenous vein, followed by~     wearing compression hose.~   "
167885|NCT01368146|"~     The purpose of this study is to determine whether contact sensitization occurs to the skin of~     normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and~     Silicone Vehicle Control dressings.~   "
167886|NCT01368133|"~     The major purpose of this study is to evaluate the changes of multiple organs in patients~     with growth hormone-secreting pituitary tumors before and after surgery. Plasma, DNA samples~     and pituitary tumor tissues will be kept for further analysis.~   "
167887|NCT01368120|"~     The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV~     Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.~   "
167888|NCT01368107|"~     The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4~     lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic~     breast cancer patients.~      The primary objective is to determine the optimal schedule to deliver CYT107 during~     chemotherapy based on restoration of CD4 count.~      This study is a phase II, randomised, double-blind, placebo-controlled, single-centre.~      24 patients will be included in the study.~   "
167954|NCT01367249|"~     This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.~   "
167955|NCT01367236|"~     The purpose of this study is to compare two different combination anti-HIV therapies over 48~     weeks and to assess if differences in improvement in the function of the brain are observed~     over this period.~      The study will compare anti-HIV therapy combinations which are currently in use.~      The patients will not have had any previous treatment for their HIV infection.~   "
167889|NCT01368094|"~     Around two thousand pancreaticoduodenectomy (PD) are performed each year in France. This~     intervention is associated with a high rate of postoperative complications including:~        -  pancreatic fistulas (PF);~        -  surgical site infections (intra-abdominal abscess, wound infection);~        -  delayed gastric emptying (gastroparesis);~        -  and hemorrhage.~      The incidence of SSI (superficial and deep) is about 35% and seems influenced by the~     prolonged intra-abdominal drainage. For several years, there has been a global trend to~     reduce the use of abdominal drainage after abdominal surgery. Several randomized clinical~     trials have shown that prophylactic drainage does not decrease the incidence of postoperative~     complications during elective hepatectomy, colectomy, and cholecystectomy and could increase~     the number of SSI. However, the role of prophylactic drainage after PD is so far unclear.~      The aim of this prospective randomized multicenter study is to evaluate the influence of~     early (4 days) versus standard (10 to 15 days, depending on the staff clinical practice)~     drainage removal of the abdominal cavity after PD, on the rate of SSI.~      Materials and Methods: The technique of PD is left at the discretion of the operator as well~     as the prescription of analogues of somatostatin. Drainage of the abdominal cavity is made of~     one or two round silicone close suction drains or open multichannel silicone drains placed in~     the vicinity of the pancreatic and biliary anastomosis. Shall be excluded patients operated~     on for chronic pancreatitis and patients who underwent preoperative radiotherapy. The 3rd~     postoperative day, a fistula is sought clinically, biologically and on CT-scanner images. In~     case of pancreatic fistula, the patient is excluded from randomization and drainage of the~     abdominal cavity is left in place depending on the different teams' practice. Patients~     without fistula are randomized to either drainage removal 4 days after surgery (D4) or~     standard drainage.~   "
167890|NCT01368081|"~     The objective of the study is to investigate the long-term safety and efficacy of BI 10773~     given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2~     diabetes mellitus with insufficient glycaemic control.~   "
167891|NCT01368068|"~     Many perimenopausal women experience severe mood symptoms for the first time in their life,~     with no past psychiatric history. The importance of clearly identifying and treating a~     disorder that is increasingly referred to as perimenopausal depression is highlighted by~     the wide-reaching impact this can have on the lives of women suffering from it. This is not a~     minor or short term mood disturbance; it is a severe depressive illness, needing effective~     and early treatment. Relationships, employment, participation in social roles and individual~     well-being can all be disrupted by the combination of the mood, hormonal and physical changes~     associated with the transition to menopause. The term perimenopausal depression denotes the~     onset of depression coinciding with the onset of reproductive hormone changes.~      Many women with this type of depression experience serious and long term debilitating~     symptoms. Treatment commonly draws on traditional approaches for the management of major~     depression including the use of antidepressants such as selective serotonin reuptake~     inhibitors (SSRIs) as the first line response. However, standard treatment of perimenopausal~     depression using antidepressants has only shown small improvements at best and at worst, is~     associated with severe side effects. Some SSRIs have been shown to be less effective in~     postmenopausal women compared to child bearing age women. Hormone treatments directly~     targeting the fluctuating reproductive hormone systems (in particular estrogen) through the~     administration of compounds such as tibolone, have significant potential as a better overall~     treatment.~      To date, there is still a lack of clear clinical evidence about the best approach for the~     biological treatment of women with perimenopausal depression. The project we now propose to~     conduct is a 12-week randomised controlled trial (RCT) of 2.5 mg/day tibolone compared to~     10mg/day of escitalopram (an SSRI that has targeted serotonin action)compared to placebo to~     discover the best treatment approach for a hitherto understudied depression that affects a~     large proportion of women in their late forties and fifties.~   "
167892|NCT01368055|"~     The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that~     has as little side effects on normal bladder and rectal tissues as the usual longer course (8~     weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.~   "
167893|NCT01368042|"~     The purpose of this study is to assess health-related Quality of Life (QoL) changes in~     participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT)~     undergoing hemodialysis and receiving paricalcitol intravenous (iv).~   "
167894|NCT01368029|"~     This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus~     rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated~     influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of~     several strains of Lactobacilli that is used as a probiotic or microorganism administered to~     confer health benefits. Our research is focused on studying the possible therapeutic~     effects of LGG. The study hypotheses are:~        1. LGG or placebo administered twice daily will be safe and well tolerated in elderly~          subjects who have just received the trivalent inactivated influenza vaccine~        2. The immune response to the influenza vaccine at day 21, 28, 56, and at the end of the~          influenza season will be higher in the LGG group than the placebo group~        3. The occurrence rate of influenza like illness during the influenza season will be lower~          in the LGG group than in the placebo group~        4. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, 56~          and at the end of the influenza season will be greater in the LGG group than the placebo~          group.~   "
167895|NCT01368016|"~     A comparison of two products for oral nicotine replacement with respect to relief of urges to~     smoke after single doses of nicotine.~   "
167896|NCT01368003|"~     In this research study, the investigators are looking to determine the safety and efficacy of~     an investigational drug, STA9090 alone and in combination with dutasteride for the treatment~     of castrate resistant prostate cancer. STA9090 may cause the growth of cancer to slow down or~     shrink by targeting proteins required for the cancer to grow. The investigators are also~     looking to determine whether the use of dutasteride to lower male hormone levels will enhance~     the effect of STA9090 in the treatment of castrate resistant prostate cancer.~   "
167897|NCT01367990|"~     The study will evaluate the safety of topical norepinephrine in head and neck cancer patients~     who are receiving treatment with intensity modulated radiotherapy (IMRT).~      The study will also provide information about whether topical norepinephrine can prevent or~     decrease the severity of the radiation-induced alopecia experienced by these patients.~   "
167898|NCT01367977|"~     It is known that 33-50% of Classic and Hypermobile Ehlers-Danlos Syndrome patients eventually~     develop dysautonomia, otherwise known as POTS (Postural Orthostatic Tachycardia Syndrome).~     Some of these patients develop dysautonomia as a result of a retroflexed odontoid, Chiari 1~     Malformation or cranial settling and the resulting basilar impression. Many Ehlers-Danlos~     patients suffer with the same symptomology with no evidence of a cause according to MRI~     imaging.~      It is the author's hypothesis that low-level External Communicating Hydrocephalus appears to~     be responsible for the constellation of autonomic and cranial nerve symptoms, and if present~     in the very young, an analysis of head circumference growth in the first 15 months of life~     should reflect abnormally rapid head growth, supporting this hypothesis.~   "
167899|NCT01367964|"~     West syndrome (WS) is a specific type of epilepsy (or seizure disorder) that has three~     features: infantile spasms (type of seizure), loss of milestones, and a specific pattern on~     electroencephalogram (EEG or brain wave test) called hypsarhythmia. The purpose of this study~     is to detect pre-hypsarhythmia in infants at high-risk for WS and determine whether treatment~     with ACTH will prevent WS.~   "
167900|NCT01367951|"~     Unstable chest injuries are common in poly trauma patients. They can lead to severe pulmonary~     restriction, loss of lung volume, difficulty with ventilation and can render the patient to~     require intubation and mechanical ventilation. Traditionally these injuries have been treated~     non-operatively, however in the past decade there has been numerous studies suggesting~     improved outcomes with surgical fixation. Surgical fixation can significantly decrease time~     spent in ICU as well as day on mechanical ventilation. The investigators aim is to conduct a~     randomized control trial of these injuries, to compare non-operative treatment with surgical~     fixation. The investigators' hypothesis is that surgically treated patient will have~     significantly improved outcomes compared to those treated non-operatively.~   "
167901|NCT01367938|"~     A prospective, matched case comparison of total knee arthroplasty with the OMNI Apex~     Ultracongruent vs. Triathlon® CS tibial insert vs. the Triathlon® PS tibial insert.~   "
167902|NCT01367925|"~     This study compares the clinical and radiographic outcomes obtained with the use of the~     Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.~   "
167903|NCT01367912|"~     To test the hypothesis that adding estradiol (E2) to progesterone supplementation later in~     the luteal phase of in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)~     cycles, rather than earlier in the luteal phase, improves clinical pregnancy rates (PRs).~   "
167904|NCT01367899|"~     The objective of this post-approval study is to provide scientifically valid and reliable~     evidence that supports claims of longer term safety and effectiveness with regard to Month~     120 device survivorship rates.~   "
167905|NCT01367886|"~     This study is being done to evaluate the use of a new technology (urine proteomics) - the~     study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a~     simple voided urine specimen.~   "
167906|NCT01367873|"~     This is a single-center, randomized, double-blind, placebo-controlled, ascending single-dose~     study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196~     in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses~     of VIA-3196 or matching placebo.~   "
167907|NCT01367860|"~     Approximately 300,000 patients undergo open surgical procedures to treat symptoms caused by~     disc herniation.~      Among the various surgical techniques practiced the percutaneous discectomy occupies its~     space since the first description of the technique by Hijikata, 1975. Throughout, many~     techniques have been described. Studies indicate that the treatment was successful for pain~     and disability resulting from herniated disc associated with radiculopathy small.~      However, some methods remove very small amounts of tissue with little change in volume of the~     disc. Thus, studies on the cadaver with Percutaneous Diskectomy by SpineJet ® showed more~     macroscopic changes of the disc with a predictable amount of removal and significant disc~     material.~      The Percutaneous Diskectomy by SpineJet ® is a new technique of percutaneous diskectomy which~     creates a suction effect in tissues adjacent to the exit point of the fluid and the opening~     point of the collector. However, no studies have examined the effect of the Percutaneous~     Diskectomy by SpineJet ® in humans about the disk size after treatment or measures of disc~     degeneration by imaging methods or how these characteristics might correlate with clinical~     outcomes.~      Thus, the study will compare outcomes of patients with contained or extruded disc herniation,~     with complaints of radiculopathy, concordant with the imaging findings. With treatment by~     surgical technique or the traditional by SpineJet ®, in order to determine whether~     percutaneous discectomy with SpineJet ® will produce results comparable to open~     microdiskectomy.~   "
167908|NCT01367847|"~     The aim of this pilot study is to determine whether a technology-enhanced version of an~     established behavioral treatment protocol, Helping the Noncompliant Child (HNC; McMahon &~     Forehand), enhances the engagement and treatment outcomes of lower income parents of 3 to 8~     children with externalizing problems in treatment. It is predicted that families in both the~     HNC and technology-enhanced HNC (TE-HNC) programs will evidence significant improvement in~     parenting behavior and child externalizing problems; however, it is predicted that~     parent-child dyads in the TE-HNC program will require fewer sessions, will be more likely to~     be retained in the program, will be more likely to remain engaged in the program (e.g.,~     practicing skills between sessions etc.), and will be more likely to have active involvement~     from their coparenting partners (i.e., other adults and family members who participate in~     childrearing).In turn, it is expected that the TE-HNC program will boost treatment outcomes.~   "
167909|NCT01367834|"~     The purpose of this research study is to learn about brain development in very young girls~     with Turner syndrome (TS) and the effect that growth hormone (GH) therapy has on early brain~     development.~   "
167910|NCT01367821|"~     Patients with obstructive jaundice (OJ) often require surgical, endoscopic or radiological~     interventions to facilitate biliary drainage and relieve jaundice. However it is known that~     patients with OJ have increased surgical risks than non-jaundiced patients undergoing the~     same procedures. Surgery for severe OJ is associated with a significant post-operative~     mortality (10-15%) and morbidity (30-65%). The commonest complications are related to sepsis~     but the pathophysiological mechanisms behind this susceptibility to bacterial infection are~     not clear. Recent work has shown a pivotal role of bile in the maintenance of enterocyte~     tight junctions and the expression of tight junction-associated proteins which could account~     for the translocation of enteric bacteria and bacterial products to mesenteric lymph node~     complexes, the portal circulation and subsequently the liver. Some of these bacterial~     products, such as endotoxin and quorum sensing signalling molecules (QSSMs), have~     immunomodulatory properties which may dampen normal immune responses to infection resulting~     in life-threatening organ dysfunction. Bacterial endotoxin and quorum sensing signalling~     molecules (QSSMs) represent good candidates for the mediators of this immune suppression and~     although there is a compelling case for their involvement in the pathogenesis of sepsis,~     evidence to support their involvement in the aetiology of infection in OJ is currently~     lacking.~   "
167911|NCT01367808|"~     Variability in drug response can be due to either pharmacokinetic or pharmacodynamic factors.~     The reasons why people differ in pharmacokinetics or pharmacodynamics are manifold and~     include, e.g., genetic factors, diseases, age and concomitantly administered drugs. Oxidation~     reactions are dominant in the metabolism of drugs and cytochrome P-450 enzymes (CYP) have~     been recognized as chief contributors. We have previously shown that drug interactions~     mediated by the inhibition of CYP enzymes may be of major clinical significance.~      This study is aimed to examine the possible interactions of low-dose sublingual buprenorphine~     with posaconazole and voriconazole.~      The study will be conducted using a randomized, balanced cross-over design in three phases.~      Twelve male or female adult non-smoking subjects aged 18-40 years with body weights within~     ±15% of the ideal weight for height will be recruited for the study. The subjects will be~     submitted to physical examination, determination of previous or present chronic diseases, and~     comprehensive laboratory testing to ascertain that they are in good health. The subjects will~     fill in a modified Finnish version of the Abuse Questions to assess their vulnerability for~     opioid abuse. Laboratory screening will include CBC (including hemoglobin, hematocrit,~     differential WBC, platelet count), SGOT, SGPT, alkaline phosphatase, BUN and creatinine, and~     for women a pregnancy test. Urine will be screened for glucose, proteins and drugs with~     addiction potential. Blood pressure in sitting position must be within normal limits. Base~     line ECG must be normal.~      The subjects will be given in a randomized, cross-over, balanced manner at intervals of four~     weeks either placebo, vorikonazole or posakonazole. On day 5, the challenge dose of 0.4 or~     0.6 mg of sublingual buprenorphine (Temgesic, Schering-Plough) will be administered at 11.00,~     i.e. 1 h after the last dose of placebo, voriconazole or posaconazole. The dose is 0.6 mg~     after placebo and 0.4 mg after posaconazole and voriconazole. If necessary, naloxone~     (Naloxone B. Braun, Braun) will be given in sufficient doses to counteract the severe adverse~     effects of buprenorphine. For nausea and vomiting, intravenous tropisetron will used, if~     needed.~      On day 4, a forearm vein will be cannulated with a plastic cannula for blood sampling. Timed~     venous blood samples will be drawn before the administration of buprenorphine and 0.5, 1,~     1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18-20 hours after administration. Another venous cannula~     will be inserted to the opposite forearm for the intravenous administration of naloxone.~     Urine will be collected for 18-20 hours.~      The psychomotor effects of buprenorphine will be assessed with visual analog scales (Bond and~     Lader 1974) and digit symbol substitution test (Stone 1984) at 1-2 hour intervals up to 12~     hours after buprenorphine administration. Visual analogue scales will be used for the~     following items: alert / drowsy, good / poor performance, no / strong drug effect, unpleasant~     /pleasant feeling, no / extreme nausea. For each pharmacodynamic variable, the area under the~     response-time curve will be determined by trapezoidal rule for 12 hours.~      The analgesic effect of buprenorphine will be evaluated using the cold pressor test.~   "
167912|NCT01367795|"~     Patients in a known palliative setting and with localized symptoms due to tumor growth will~     be evaluated for their quality of life before and after a surgical intervention (primary~     endpoint). Medical outcome in terms of length of stay in hospital, length of stay on a~     intensive care unit, complications, reinterventions will be recorded (secondary endpoints).~     The investigators will also observe patients with conservative treatment.~   "
167914|NCT01367769|"~     Background:~      Contrast-enhanced ultrasound (CEUS) visualization of the adventitial vasa vasorum. Late phase~     CEUS detect inflammation by visualizing microbubbles phagocytosed by monocytes. The~     inflammatory process of the vessel wall associated with perivascular angiogenesis at the time~     of deep venous thrombosis (DVT) and superficial vein thrombophlebitis (SVT) may important in~     the development of post-thrombotic syndrome (PTS). Therefore the investigators will test the~     value of CEUS to detect venous perivascular vascularization and inflammation in patients with~     acute DVT or SVT.~      Aims:~      To determine the presence and degree of venous perivascular vascularization and inflammation~     assessed with CEUS in patients with acute DVT or SVT, and compare this to controls without~     thrombosis.~      Expected results:~      The investigators hypothesize that venous perivascular vascularization and inflammation~     assessed by contrast agent enhancement can be quantified and will be significantly more~     pronounced in the perivascular tissue of the thrombotic vein than in the non affected vein~     and in controls, and will correlate with level of inflammatory markers and leg volume.~      Significance:~      These results would provide new information on the pathophysiological concept of thrombosis~     and thrombus resolution. It might help to better understand the pathophysiologic mechanisms~     that promote the development of chronic venous insufficiency and PTS.~   "
167915|NCT01367756|"~     This randomized, double-blind, parallel-arm study will assess the safety and tolerability of~     RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive~     citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo~     in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.~   "
167916|NCT01367743|"~     The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after~     reperfused myocardial infarction will be compared, by following cardiac index evolution as~     main criteria. The study is a pilot pathophysiological study, randomized, double blind and~     multicenter.~   "
167917|NCT01367730|"~     In the context of male osteoporosis, we hypothesize that regional changes in trabecular bone,~     as well as changes in cortical porosity will play a major role, and thus also affect bone~     strength. In developing therapeutics the response of individual compartments, regional~     variations post-therapy will have considerable impact on selecting the therapies as well as~     monitoring response to therapy. This study, a precursor to other therapeutic trials, will lay~     the ground-work for the future.~   "
167918|NCT01367717|"~     Background: Creatinine (Crn) concentration is used to assess renal function via calculation~     of GFR (Glomerular Filtration Rate). By RIFLE (Risk, Injury, Failure, Loss, End Stage Kidney~     Disease) criteria, acute kidney injury (AKI) and acute renal failure (ARF) are defined by a~     two-fold and three-fold increase in serum Crn, respectively. Crn is a breakdown product of~     proteins and circulating creatine, and it is generally a benign product present in serum.~     Creatine is a nutritional supplement that has been available since 1993, and it is widely~     used among athletes today.~      Methods: In an IRB approved, blinded crossover trial, 25 human volunteers ingested 2 creatine~     supplements to determine any associated statistically significant increase in serum Crn and~     clinically significant increase in serum Crn to a degree associated with AKI or ARF. Urine~     samples were also collected to examine excretion patterns after an ingested sample.~     Participants ingested 10 gm of creatine ethyl ester (CEE) or creatine monohydrate (CrM) and~     had serum Crn assayed at 0, 1, 2, 3, 4, 5 and 24 hours. Urinary Crn levels were assayed at 0,~     1.5, 3, 5 and 24 hours. Exclusion factors were any history of renal disease or use of~     creatine within the last month. Statistical analysis was performed by Wilcoxon Matched-Pair~     Signed Ranks Test and descriptive summary statistics were performed.~   "
167919|NCT01367704|"~     Despite the high prevalence of adolescent relationship abuse (ARA) reported among adolescent~     females and substantial reports of perpetration by young males, effective prevention programs~     to prevent ARA are limited. Male athletes are an important target for prevention efforts~     given their higher rates of abuse perpetration compared to non-athlete peers as well as their~     social influence among their peers. This cluster-randomized school-based investigation~     examines the effectiveness of a program for the primary prevention of ARA. Coaching Boys~     into Men (CBIM) is a social norms theory-based program intended to alter norms that foster~     ARA perpetration, promote bystander intervention, and reduce ARA perpetration by engaging~     athletic coaches as positive role models to deliver violence prevention scripts and tools to~     high school age male athletes. Coaches receive a 60-minute training session to administer the~     intervention to their athletes via 11 lessons across a sport season. Trained high school~     coaches talk to their male athletes about 1) what constitutes disrespectful and harmful vs.~     respectful behaviors, 2) promoting more gender-equitable attitudes, and 3) modeling bystander~     intervention when disrespectful behaviors toward women and girls are witnessed. The current~     investigation evaluates the intervention in 16 urban high schools randomized either to~     receive the CBIM program (i.e., intervention schools, n=8) or to a control condition (n=8).~     Baseline computer-based surveys are collected for all intervention and control site student~     athletes entering grades 9 through 12 at the start of each of three sports seasons across~     Year 1 (Time 1). Follow up surveys are collected for these same athletes at the end of their~     first sports season (Time 2). Participating athletes in grades 9 - 11 at baseline are~     re-surveyed 12 months after Time 1 to examine the longer term effects of the CBIM~     intervention (Time 3; N of athletes completing all 3 waves of data collection = 1500).~     Primary assessment of intervention effects are based on intent-to-treat estimates, utilizing~     generalized linear mixed models to account for clustering arising from school randomization.~     Hypothesized outcomes for male athletes include a) an increase in recognition of what~     constitutes abusive behaviors, b) more gender-equitable attitudes, c) an increase in~     intentions and reports of bystander intervention regarding ARA, and through these~     intermediate outcomes, d) a decrease in perpetration of ARA among adolescent male athletes.~   "
167920|NCT01367691|"~     Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients~     with CRT.~      Goals are to demonstrate that~        -  differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause differences~          in myocardial activation~        -  differences in LV-RV pacing delays cause differences in LV/RV hemodynamics~      and to use these data to optimize CRT.~   "
167921|NCT01367678|"~     In the following randomized non-crossover study, the investigators test the hypothesis that~     directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and~     the i-Gel in paralyzed anesthetized females.~      Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA~     Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA~     Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx;~     C, hypopharynx; and D, pyriform fossa.~      Insertion success rate and oropharyngeal leak pressure were also measured.~   "
167922|NCT01367665|"~     This single-arm, open-label, multi-center study will evaluate the safety and efficacy of~     vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma.~     Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or~     unacceptable toxicity.~   "
167923|NCT01367652|"~     The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted~     conditions.~   "
167924|NCT01367639|"~     Breast cancer (BC) is a major health problem and the most prevalent cancer among women.In a~     substantial proportion of familial cases, germ-line mutations in either BRCA1/2 can be~     detected. The only proven modality for active risk reduction (rather than passive early~     detection), is prophylactic surgery - prophylactic mastectomy and oophorectomy. While the~     majority of Jewish mutation carriers elect to undergo prophylactic oophorectomy at about age~     40 years, in Israel only a minority perform prophylactic mastectomy. Another ramification of~     being a mutation carrier is the emotional stress associated with that discovery.Genetic~     information has profound implications for mutation carriers. The IBSR (Inquiry-based stress~     reduction) intervention, developed by Byron Katie, trains participants to reduce their~     perceived level of stress by self-inquiry of their thoughts and beliefs connected to~     stressful circumstances or symptoms. This meditative process, named The Work, enables the~     participants to identify and question the stressful thoughts that cause their suffering. The~     core of IBSR is simply four questions and a turnaround, which is a way of experiencing the~     opposite of what the participant believes. This process is simple, powerful and provides~     skills for self-inquiry and management of stressful thoughts that can be easily implemented~     in daily life [ ]. Therefore, on the basis of previous data and beneficial observations we~     postulate that the clinical utility of IBSR mediation program may improve psychological and~     physical symptoms and quality of life among asymptomatic (oncologically healthy) BRCA1/ BRCA2~     mutation carriers. Thus, we will conduct a pilot randomized controlled trial to~     scientifically investigate the effect of this intervention effects on BRCA1/2 mutation~     carriers.~   "
167925|NCT01367626|"~     The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed~     conditions.~   "
167926|NCT01367613|"~     This is a 3 month open-label extension study that allows patients who completed Protocol MNTX~     302 to receive SC MNTX.~   "
167927|NCT01367600|"~     This study is an open-label extension allowing patients who have completed Protocol MNTX 301~     to continue to receive SC MNTX.~   "
167928|NCT01367587|"~     This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.~   "
167929|NCT01367574|"~     This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous~     methylnaltrexone to be conducted in patients with advanced medical illness and poorly~     controlled opioid induced constipation. Patients will be randomized to one of three fixed~     dose levels of SC MNTX.~   "
167930|NCT01367561|"~     This is a double-blind, randomized, study at a single clinical site investigating the effect~     of methylnaltrexone and naloxone versus placebo in healthy males who have received a~     short-acting opioid, remifentanil.~   "
167931|NCT01367548|"~     A double-blind, randomized, parallel-group study designed to evaluate the safety and activity~     of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental~     colectomies via laparotomy.~   "
167932|NCT01367535|"~     This study is a single-center, randomized, open-label, active and placebo-controlled,~     parallel-group, conducted in healthy male volunteers who have been shown to be extensive~     metabolizers of dextromethorphan.~   "
167933|NCT01367522|"~     This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will~     receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight~     subjects from each classification of hepatic impairment will be enrolled. Plasma samples will~     be collected before and at specified intervals after dosing and the concentration of MNTX~     will be analyzed.~   "
167934|NCT01367509|"~     This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in~     patients with mild, moderate, or severe renal impairment who do not require hemodialysis.~   "
167935|NCT01367496|"~     This is an open-label, Phase I study. Study treatments will entail a four-way crossover among~     three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy~     normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics,~     dose proportionality for subcutaneous doses, and absolute bioavailability versus an~     intravenous dose.~   "
167936|NCT01367483|"~     This is an open-label, radiotracer study, to be conducted in healthy, normal, male~     volunteers. It will entail intravenous administration of a single dose of 14C-MNTX,~     collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be~     sampled as a measure of the extent of possible metabolic MNTX demethylation.~   "
167937|NCT01367470|"~     The newborn immune system is influenced by maternal immunity through both placenta and~     breastfeeding.~      There exists a close interaction between the mother and the baby during gestation and~     lactation. Maternal milk contains a number of factors that protect the newborn against~     infections including 1) cytokines and their receptors which are also thought to play a role~     in the protection against allergies; 2) oligosaccharides with low molecular weight and 3)~     probiotic bacteria that contribute to the development of the newborn immune system.~      Probiotics have a potent immunogenic activity as well as an immunoprotective potential in~     maternal milk after administration of probiotics during pregnancy and breastfeeding. In~     addition probiotics are supposed to play a role in the increased production of~     sphingomyelinase.~   "
167938|NCT01367457|"~     The principal objective of the study is to evaluate the efficacy and safety of temsirolimus~     use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.~   "
167939|NCT01367444|"~     Primary Objective:~      To assess the safety and tolerability of ascending doses of SAR422459 in patients with~     Stargardt's Macular Degeneration.~      Secondary Objective:~      To evaluate for possible biological activity of SAR422459.~   "
167940|NCT01367431|"~     The purpose of this study is to determine the pharmacokinetics (PK) of xanthohumol (XN).~     Small amounts of xanthohumol occur naturally in hops, used to make beer, and XN is also found~     in beer itself. Studies in animals have shown that XN can lower blood sugar and blood lipids~     such as triglycerides, which can contribute to heart disease. The purpose of this study is to~     see how much of the XN is absorbed into the blood and how fast it leaves the body when taken~     by mouth. Once the PK study has been done, the investigators' long-term goal is to learn if~     xanthohumol can lower risk factors for heart disease and type-2 diabetes in humans.~   "
167989|NCT01366781|"~     The study hypothesis is that the release of gut hormones is increased proportionally to~     caloric load in each meal. Three different meals with different meal size will therefore be~     served and gut hormones determined.~   "
167941|NCT01367418|"~     Several recently published retrospective studies show that regional anaesthesia (RA) can~     reduce cancer-related mortality following surgical treatment of colorectal, breast and~     prostate cancers and malignant melanoma. If these results are true, then the choice of~     perioperative pain management is as beneficial, or even better, than the current oncological~     therapies. This theory needs to be investigated in a prospective, randomized and controlled~     trail. We shall perform a prospective, randomized study comparing the effects of Thoracic~     epidural analgesia (TEA) or patient controlled analgesia (PCA) on postoperative immunological~     and inflammatory markers in order to understand whether the protective effects, if any, of~     regional analgesia are due to changes in these markers or whether the underlying mechanisms~     is not mediated via this stress signalling pathway.~   "
167942|NCT01367405|"~     Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical~     entity. The most characteristic feature is the disproportionate more motor impairment of the~     arms and especially the hands than the legs, bladder dysfunction and sensory.~      Recently, it has been shown that the distinction of TCCS with an incomplete cervical spinal~     cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord~     lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact~     incidence is not known.~      Uncertainty about the treatment exists. A good recovery has been described after conservative~     treatment. Conservative treatment was usually considered when a fracture or dislocation of~     the spine were absent. It is often seen in hyperextension trauma in the elderly with~     degenerative spondylotic stenotic cervical spine. However, some reports suggest a better~     outcome after surgical decompression. Randomized trials have not been performed. To avoid~     discussion about possible confounding or effect modification related to the mechanism of~     trauma, this study will focus on ICSCL in patients without fracture or instability of the~     cervical spine on radiological examination. Also the problem of crossover from the~     conservative group to the surgical one due to the nature of spinal instability will be~     reduced.~      Goal of the study: To compare the efficacy of early decompressive surgery to improve~     functional outcome in patients with ICSCL without a fracture or instability of the cervical~     spine compared to those receiving conservative treatment.~      Definition of ICSCL in this study: ICSCL is an incomplete spinal cord lesion due to a~     cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that~     could indicate a fracture of the cervical spine or instability. An overt sequestrated~     herniated disc should not be present since this will always necessitate immediate surgery.~     Involvement of the cervical spinal cord should be established at physical examination~     (symptomatic arm or hand dysfunction is obligatory).~   "
167943|NCT01367392|"~     The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle~     Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations .~     The device used in this study is designed to assist the physician in guiding the needle~     towards the suspected area. This device does not change the procedure of liver biopsy or~     ablation. The only difference is that a small adhesive pad is placed on the skin and a~     miniature video camera is attached to the end of the needle. This camera does not enter the~     body.~   "
167944|NCT01367379|"~     The investigators will study in the possibility of cardiovascular disease, caused by the duty~     loading, of physician of internal medicine. The investigators will also explore if there~     {dose response effect} between the duty loading and the stress response of physicians of~     internal medicine. Therefore, the investigators will compare the stress responses of~     physicians of internal medicine during with different duty loading ( non-duty day, one duty~     area with 3 wards, 2 duty areas with 6 wards) in a observational method. Those stress~     response will be measured by cardiovascular risk indicators, including blood pressure, heart~     rate variability, blood sampling and urine sampling.~   "
167945|NCT01367366|"~     Lung cancer is the leading cause of death in Taiwan. The outcomes of the disease vary~     depending on early detection, histologic types and staging. Because the mediastinal~     involvement including lymph node status is a significant prognostic factor for survival,~     lymph node biopsy is necessary for clinical staging of some patients. Although~     fluorodeoxyglucose-positron emission tomography (FDG-PET) is suggested for precise evaluation~     of mediastinum, tissue proof of PET positive lesions are recommended due to its limited~     diagnostic specificity for identifying mediastinal metastases. Cervical mediastinoscopy~     remains the gold standard for mediastinal lymph node sampling. However, it is invasive,~     requires general anesthesia. Another new minimally invasive method of mediastinal biopsy is~     real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The~     aim of this study is to compare the accuracy of PET and EBUS-TBNA for correct staging of the~     mediastinum for lung cancer patients.~   "
167946|NCT01367353|"~     Specific aims: Identification and characterization of cancer stem cell-like population~     (cancer stem cells or cancer initiating cells) from primary tumor tissue, primary ascites and~     peripheral blood of ovarian cancer patients and genetically engineered mouse ovarian cancer~     cell lines.~      Objectives: In the future, individualized therapy must incorporate analysis of the cancer~     stem cells or cancer initiating cells of ovarian cancer cells when designing therapeutic~     strategies for ovarian cancer patients.~      Aims of this project:~        1. Isolation and identification of cancer stem cell-like population (cancer stem cells or~          cancer initiating cells) from primary tumor tissue, primary ascites and peripheral blood~          of ovarian cancer patients~        2. In vivo tumorigenicity assay will be performed to measure tumor formation from these~          cancer stem cell-like population when equal numbers were injected into the dorsal fat~          pad of nude mice.~        3. To establish a standard protocol of stem cell-like population maintenance~        4. Screening of potential specific biomarkers involved in these ovarian cancer stem~          cell-like population.~   "
167947|NCT01367340|"~     The purpose of this study is to investigate the effects of a 6-month physical activity~     intervention program on mobility and participation after the termination of a 6-week~     functional strengthening program for school-age children with spastic diplegia cerebral~     palsy. The primary outcomes are gross motor function, participation, and physical activity~     behavior.~   "
167948|NCT01367327|"~     The purpose of study is to investigate the effects of PSE Music with a home-based loaded~     STS exercise program on the functional strength, gross motor function, daily participation,~     exercise involvement, motor control, and gait speed for children with spastic diplegia.~   "
167949|NCT01367314|"~     This is a randomized, double-blind study comparing 0.1% NVC-422, 0.5% NVC-422 and 1.5%~     NVC-422 topical gel in children with impetigo.~   "
167950|NCT01367301|"~     This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating~     patients with uterine cancer. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or stopping them from dividing.~     Giving radiation with chemotherapy may kill more tumor cells.~   "
167951|NCT01367288|"~     Breast cancer is the leading female cancer by a very wide margin in France. Despite~     widespread breast cancer screening, many cases of breast cancer are discovered at a locally~     advanced stage. The tumoral consequences of a cancer size greater than 3 cm are: increased~     risk of metastasis and death and, most often, impossibility of performing breast-conserving~     surgery (a mastectomy is usually advisable in case of a first surgical procedure). It is~     increasingly recommended to treat locally advanced breast cancers with neoadjuvant~     chemotherapy. Very numerous studies have shown that by proceeding that way, the oncologic~     prognosis was not harmed and, on the contrary, it was possible to obtain sufficient tumor~     response to allow breast-conserving treatment in more than 60% of cases.~      The use of zoledronic acid (Zometa) has an established place in the management of~     malignancies with a predilection for skeletal involvement (in particular metastasis).~     Although the main target of biphosphonates is the osteoclast, there is also preclinical data~     indicating that biphosphonates can have effects on cells other than osteoclasts, including~     tumor cells. Anti-tumor activity including inhibition of tumor cell growth and induction of~     tumor cell apoptosis, inhibition of tumor cell adhesion and invasion, and anti-angiogenic~     effects have been demonstrated. In addition several in vitro studies have shown that Zometa~     causes synergistic induction of breast cancer cell apoptosis when combined with clinically~     relevant concentrations of chemotherapy drugs such as paclitaxel and doxorubicin. Therefore~     testing of combinations of biphosphonates with these agents in breast cancer is of~     significant interest.~      In the context of locally advanced breast cancers, the combination of a bisphosphonate with~     neoadjuvant chemotherapy appears to have an important potential: preventing possible bone~     metastases, but also possibly amplifying the efficacy of the chemotherapy's tumoricidal~     activity, both on the primary tumor and on potential metastatic localizations.~      So it appears that, the use of bisphosphonates in a neoadjuvant situation presents a~     potentially favorable benefit-risk ratio. That is why we are proposing to perform a~     prospective randomized multicenter comparative study to evaluate 2 systemic neoadjuvant~     treatments, one with Zometa and the other without Zometa, in patients with locally advanced~     breast cancer. Zometa will be administered according to the usual administration procedure:~     one infusion every 3 weeks.~      The therapeutic response will be evaluated by studying the different biological markers~     (circulating blood and bone marrow tumor cells, serum cell apoptosis and neoangiogenesis~     markers, bone resorption markers, etc.), but also by analyzing clinical, radiologic, and~     histologic response and by breast conservation rates. The impact of other factors that may~     affect therapeutic response will be taken into account: aggressivity of the tumor, presence~     or absence of tumor receptors, tumor stage, etc.~      The purpose of the study is to show a marked benefit of treatment with Zometa in managing~     locally advanced breast cancers with synergistic action of the neoadjuvant chemotherapy and~     improvement in the laboratory parameters of tumor aggressivity. These markers will be used as~     surrogate markers of long term outcome.~   "
167990|NCT01366768|"~     The study hypothesis is that gut hormones are released after oral but not intravenous amino~     acids which result in stimulation of insulin secretion.~   "
167956|NCT01367223|"~     This study aims to describe the use of glutamine supplementation in the modulation of~     inflammatory response in critically ill pediatric patients and to determine if this decrease~     leads to clinical improvement in morbidity and mortality in these patients. Thus, these~     patients' diet could be supplemented with glutamine in order to improve their evolution.~      Hypothesis:~      From the data obtained in the study of the literature the investigators consider that:~      Critically ill patients have a deficit of glutamine either because of an increase in its~     consumption or a decrease in its availability, and therefore blood glutamine levels are low.~      Critically ill patients have elevated blood levels of pro-inflammatory substances (IL-6).~      In these patients tissue lesion inhibitors (HSP-70) in the blood are decreased. The~     administration of glutamine supplements to these patients decreases oxidative stress due to~     the increase in HSP-70.~      Inflammation inhibitory substances (IL-10) in the blood are decreased in these patients.~      The administration of glutamine supplements in these patients increase IL-10 levels.~      Glutamine supplements decrease the inflammatory response with a decrease in IL-6 levels.~   "
167957|NCT01367210|"~     Objectives of the study:~        1. To verify the safety and the efficacy of the study treatment, defined as the persistent~          control of the virus' replication at 48 weeks after the simplification to maraviroc +~          darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping.~        2. To collect relevant information about the safety, the immunologic and the economic~          impact of this strategy.~   "
167958|NCT01367197|"~     PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic~     heart failure, while little is known about the effect in atrial fibrillation (AF). The~     investigators studied the effect of physical exercise on cardiac output (CO), max. exercise~     capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of~     physical exercise training three times weekly for twelve weeks.~      HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers~     and quality of life (Qol) in patients with AF.~      METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and~     muscular strength was performed before and after 12 weeks.~      Resting echocardiography was done at baseline. CO was measured using impedance cardiography~     at rest and during maximal exercise testing on an ergometer bicycle. Body composition,~     muscular strength and six minutes walking capacity were measured before and after the~     training period. Qol was evaluated by the use of the standardized validated questionnaires~     Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).~      Training consisted of aerobic exercise at 70 percent of max. capacity estimated by~     Borg-scale.~   "
167959|NCT01367184|"~     Inferior vena cava (IVC) filter is an important therapeutic device used in the management of~     venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation~     therapy. While there has been significant increase in the use of filters , unfortunately~     there are no standardized collection of data to track, compare outcomes, report safety and~     efficacy.~   "
167960|NCT01367158|"~     This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a~     meningococcal vaccine formulation in adolescents.~   "
167961|NCT01367145|"~     The principal aim of the study is to determine the effects n3-PUFA on top of standard therapy~     on surrogate markers of disease severity and/or prognosis in patients with PAD.~      Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion.~      Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation~     using brachial artery ultrasound.~      Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse~     wave velocity, whole blood viscosity, platelet activation and plasma markers of inflammation.~   "
167962|NCT01367132|"~     The primary objective of this study is to determine the detection rate of two- or~     three-vessel umbilical cord at the time of nuchal translucency screening between 11 and 13~     6/7 weeks gestation.~      Hypothesis: Detection rate of the number of vessels during first trimester will be as~     accurate as the detection of vessels during the second trimester.~   "
167963|NCT01367119|"~     Does the use of ketamine as the anesthetic medication in electroconvulsive therapy (ECT)~     accelerate the antidepressant effect of ECT?~      The study hypothesis was that depressed subjects receiving ECT with ketamine as the~     anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression~     ratings after the second ECT than depressed patients receiving ECT with the usual anesthetic~     agent.~   "
167964|NCT01367106|"~     The main objective of this study is to show that the fetal exposure to excess of~     glucocorticoids is associated with a deficiency of the function beta insulin in the offspring~     adult.~   "
167965|NCT01367093|"~     The purpose of this study is to identify within a cohort of ICU patients admitted for severe~     illness those who are at risk of death in the year following the discharge from ICU.~   "
167966|NCT01367080|"~     To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride~     film-coated tablet 10mg & 25mg~   "
167967|NCT01367067|"~     The objective of the study is to search for possible predictors for claustrophobia during~     magnetic resonance (MR) imaging. A claustrophobic event shall be defined by an incomplete~     examination, or a complete examination that requires coping actions by the staff. Coping~     actions may consist of the administration of sedatives, prism glasses, an MR imaging test run~     with the patient, a pause, the prone position, an escort in the scanner room, and supportive~     communication. The investigators hypothesize that there is a difference between patients with~     and without events in their scores on the Claustrophobia Questionnaire and several further~     psychometric questions. Other factors may also favour events like patient characteristics,~     examined region, duration of the examination and scanner type. Therefore, predictors could~     identify patients who are likely to experience claustrophobia during MR imaging so that they~     can receive the appropriate support by the staff to complete their examination. Thus a larger~     patient population could benefit from MR imaging.~   "
167968|NCT01367054|"~     The objective is evaluate, in healthy volunteers, the bioavailability of two products~     containing metformine 500 mg to determine if they are bioequivalent and identify the~     occurrence of adverse events.~   "
167999|NCT01366638|"~     The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination~     with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus~     (HCV)-infected participants who are treatment-naive or treatment-experienced (prior relapser~     or non-responder to Interferon-based therapy) in Japan.~   "
167969|NCT01367041|"~     The aim of this study is to investigate effects of femur exposed to vibration on the rest~     muscle electrical activity of hip adductors in cases with postmenopausal osteoporosis.~      Among patients who will be admitted to the investigators clinic for out-patients and whose~     bone densitometric measurement will be made with a prediagnosis postmenopausal osteoporosis,~     a total of 80 voluntaries [40 having postmenopausal osteoporosis (femur neck or total hip T~     score < -2.0) and 40 Controls (Hip and lumbar bone mineral density normal)] are planned to~     include in this study.~      After the left hip bone mineral density (BMD) and BMC is measured in all cases, whole body~     vibration will be applied in PMO groups and Controls. The rest muscle electrical activity of~     left hip muscles will be evaluated at pre-treatment, post-treatment and, during treatment in~     patients with PMO and then their data will be compared with Controls data.~      Plasma sclerostin level will be measured before and 10th minute after vibration.~      Cases will stand on vibration plate. WBV will be applied at a frequency of 40 Hz and~     amplitude of 2 mm for 30 + 30 seconds. WBV will be applied one session only. The left hip BMD~     and BMC will be evaluated by bone densitometer (Norland).~      The rest muscle electrical activity of hip adductor muscles at rest will be measured by~     PowerLab (data acquisition system, ADInstruments, Australia) device.~      This project is planed to be completed in 3 months.~   "
167970|NCT01367028|"~     Multicenter randomised phase II study of neoadjuvant therapy in HER2 positive early breast~     cancer. Primary aim is to evaluate the cardiac toxicity of the combined treatment~     (trastuzumab, docetaxel, bevacizumab, NPLD) in comparison to the standard therapy.~   "
167971|NCT01367015|"~     The purpose of the study is to compare early versus late initiation of enteral feeding in~     premature growth restricted babies below the gestational age of 35 weeks born to mothers with~     prenatal absent or reversal of end diastolic flow in the umbilical artery. Normally the blood~     flow from the mother to the baby brings all the nutrients required for growth and the very~     vital oxygen required for survival. These deprived babies with poor blood flow adapt to the~     not so conducive uterine environment by certain adjustments in blood supply to internal~     organs. This permits the best possible blood flow to brain heart etc., which are the vital~     organs and whose adequate functioning is required for survival. As a consequence, the gut~     (intestines) gets poor blood supply and hence its appropriate functioning may be jeopardized.~     Such 'premature growth restricted' babies are at increased risk of further growth faltering~     if not fed adequately as also to a condition called 'Necrotising enterocolitis' if fed~     liberally like other healthy neonates, characterized by abdominal distension, blood in stools~     and inability to feed for longer durations thereby further affecting growth. In the past such~     babies (after birth) were not fed for days together which compromised their growth even~     further. It is not clear whether continuing to withhold feeds for prolonged duration will~     prevent NEC but lead to growth faltering and initiating feeds early will potentiate NEC with~     further compromised growth and increased morbidity. There are no randomized trials on feeding~     strategies in this group of neonates and hence the investigators planned to carry out this~     study on comparison of early versus delayed initiation of feeding in preterm SGA infants with~     AREDF.~   "
167972|NCT01367002|"~     The primary objective of this study is to estimate whether the addition of trastuzumab to~     paclitaxel and carboplatin chemotherapy improves progression free survival when compared to~     paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients~     overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence~     in situ hybridization (FISH).~   "
167973|NCT01366989|"~     The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle~     Arthroplasty in patients having a calcaneal stem.~   "
167974|NCT01366976|"~     Acute kidney injury is a major complication of cardiac surgery requiring cardiopulmonary~     bypass (CPB). Hemolysis and rhabdomyolysis frequently occur during CPB. Hemolysis leads to an~     increase in free hemoglobin, whereas rhabdomyolysis leads to an increase in myoglobin. Free~     plasma hemoglobin and myoglobin have been shown to be independent predictors of the acute~     kidney injury that results from CPB. When these hemeproteins are released into the plasma,~     they undergo redox cycling, generating radical species that initiate lipid peroxidation and a~     cascade of oxidative damage to cellular membranes, notably in the kidney. F2-isoprostanes and~     isofurans are sensitive and specific markers of oxidative stress in vivo, and are increased~     after CPB, particularly in those patients with acute kidney injury. Acetaminophen inhibits~     the lipid peroxidation catalyzed by myoglobin and hemoglobin. Moreover, in an animal model of~     rhabdomyolysis-induced kidney injury, acetaminophen significantly attenuated the decrease in~     creatinine clearance compared to control. The current proposal tests the central hypothesis~     that acetaminophen will attenuate the lipid peroxidation associated with the hemolysis and~     rhabdomyolysis that occur in patients undergoing CPB. Demonstration that acetaminophen~     inhibits the lipid peroxidation resulting from CPB would provide a rationale for a~     prospective randomized trial to test the hypothesis that acetaminophen will reduce the acute~     kidney injury that results from CPB.~   "
167975|NCT01366963|"~     A common complaint among people with Postural Tachycardia Syndrome (POTS) is brain fog or~     difficulty concentrating. This is very poorly understood. To better understand this cognitive~     dysfunction, the investigators will test people with POTS and people without POTS using~     various neuropsychiatric instruments. The investigators hypothesis is that people with POTS~     will have greater abnormalities on neuropsychiatric testing than normal controls.~   "
167976|NCT01366950|"~     The purpose of this study is to determine if intelligent physical exercise training can~     increase the productivity of office workers in Denmark. Effects of intervention is measured~     after 1 and 2 years.~      The project is driven as a change project.~      The investigators measure productivity as:~        -  Individual health~        -  Sick leave~        -  Retention at the workplace~   "
167991|NCT01366742|"~     The natural history of human papillomavirus (HPV) is most likely influenced by both innate~     and adaptive mucosal immunity. More specifically, we hypothesize that Toll like receptors~     (TLR) play an important role in cervical innate immunity to HPV through secretions of~     proinflammatory, chemotactic and anti-viral cytokines. Up-regulated TLR expression will also~     result in activation of dendritic cells and T cells that in turn will promote a T helper (Th)~     l like response through secretion of several cytokines and consequently, the induction of a~     successful cell mediated immune (CMI) response.~   "
168000|NCT01366625|"~     The purpose of this study is to investigate the clinical utility of renal denervation for the~     treatment of resistant hypertension coexisting with obstructive sleep apnea.~   "
167977|NCT01366937|"~     The hypothesis of this study is that chicken eggs can be enriched in vivo with 14C-B12 and~     fed to healthy human subjects to determine B12 bioavailability from eggs.~      The goal of this research is to enrich eggs in vivo with radioactively labeled vitamin B12 to~     a level that allows us to feed the enriched eggs to humans and determine how much of the~     vitamin B12 is digested and absorbed into the body. This will tell us if eggs are a good~     dietary source of vitamin B12. Importantly, sensitive technology available at the Lawrence~     Livermore National Laboratories allows us to measure very low amounts of radioactive vitamin~     B12. This allows us to do this experiment with a level of radioactive B12 that is not harmful~     to animals or humans. The results of the investigators first experiment indicate that the~     investigators can inject radioactively labeled vitamin B12 into a laying hen and detect the~     radioactive vitamin B12 in the eggs at a level sufficient for feeding to humans in a~     bioavailability study.~   "
167978|NCT01366924|"~     The modern warfighter faces numerous physiological challenges including sleep deprivation,~     sustained intense physical activity, and caloric restriction, the combined effects of which~     may result in the loss of lean body mass and decreased physical performance. Dietary~     interventions may help preserve lean body mass and facilitate recovery from periods of~     intense physical demand. For example, dietary strategies that increase amino acid~     availability have been shown to stimulate protein synthesis in skeletal muscle following~     resistance exercise. Because military tasks also incorporate endurance exercise components,~     studies regarding the effects of increasing dietary amino acids following endurance exercise~     are warranted. The objectives of this study are to characterize the effect of endurance~     exercise on protein synthesis and breakdown as well as the ability of an essential amino acid~     supplement to influence skeletal muscle protein metabolism and its cellular and molecular~     regulation following endurance exercise.~   "
167979|NCT01366911|"~     This is a pilot study to provide preliminary data of the association between bone mineral~     denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT),~     at least 2 years post Total Hip Arthoplasty (THA) surgery with Mesechymal stem cell assays,~     obtained at time of surgery, and to begin to evaluate if stem cells can predict orthopaedic~     surgical outcomes.~   "
167980|NCT01366898|"~     The protocol objective is providing adequate treatment and based on broad consensus in~     elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that~     enables a joint analysis of results strong enough to make conclusions on specific subgroups~     of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of~     age or associated diseases). Provide results of a treatment to consider standard against~     which to compare the results of phase II trials of experimental drugs that undoubtedly will~     be activated in the coming years~   "
167981|NCT01366885|"~     The purpose of this study is to determine whether by administering vitamin D to mothers who~     already have at least one child with autism and who are pregnant, that the vitamin D will~     prevent the recurrence of autism in the newborn sibling.~   "
167982|NCT01366872|"~     This is a research study which is being done to determine the outcomes following Agility LP~     ankle replacement. This implant was approved by the FDA in 2007 and has been used since then~     with good early results. You are being asked to volunteer for this study because you have~     undergone Total Ankle Arthroplasty with Agility LP prosthesis. The purpose of the study is to~     compare the range of motion, level of pain and function during daily living prior to and~     after your ankle surgery.~   "
167983|NCT01366859|"~     This study will evaluate the effects of a cysteine-rich whey protein isolate supplement~     (Immunocal®) on autistic behavior in pre-school children with autism.~   "
167984|NCT01366846|"~     ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).~      Peanut Allergy, a recognized public health concern, is a common and potentially~     life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study~     evaluated whether early exposure to peanut promotes tolerance and provides protection from~     developing peanut allergy in children who are allergic to eggs or who have severe eczema.~     ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect~     of twelve months of cessation of peanut consumption in LEAP Study participants who consumed~     peanut and those who avoided peanut over the previous five years.~   "
167985|NCT01366833|"~     According to the Canadian Cancer Society there are approximately 1700 new cases of esophageal~     cancer per year in Canada. As most of these patients are diagnosed in advanced stages of the~     disease, 1800 deaths are estimated from this cancer annually . Progressive dysphagia is the~     most common presenting symptom and impacts not only the patient's quality of life but the~     ability to tolerate life prolonging treatments such as systemic chemotherapy.~      Although there are several therapeutic modalities to alleviate malignant dysphagia including~     laser, photodynamic therapy and cryotherapy , the use of stents and radiotherapy are the most~     commonly employed. However, the optimal approach to effective, timely treatment of malignant~     dysphagia remains a challenge. The investigators conducted a preliminary retrospective review~     to investigate such palliation procedures and found that a multi-modality approach may yield~     the most favourable results .~      Therefore, our clinical trial will examine the effectiveness of adding a single dose of~     brachytherapy to patients with severe dysphagia who have already been treated with a~     endoscopically placed self-expanding metallic stent.~   "
167986|NCT01366820|"~     The purpose of this study is to determine whether NNZ-2566 is safe and effective in the~     treatment of Traumatic Brain Injury (TBI).~   "
167987|NCT01366807|"~     Screening of nutritional status is unsolved problem in cardiac surgery. Applicability of such~     criteria as body mass index and albumin and screening scales (MNA, NRS-2002, SGA, SNAQ) in~     cardiac surgery is controversial and insufficiently studied. Furthermore, there is some known~     predictors of poor outcome, which closely related to nutritional status (C-reactive protein,~     total lymphocyte count). The aim of this study is assessment of several nutritional screening~     scales, objective nutritional criteria and predictors for the purpose of detection of most~     informative one or its combination.~   "
167988|NCT01366794|"~     Study hypothesis is to examine the relative contribution of macronutrients for gut hormone~     secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes.~     Individual macronutrients or a mixed meal will therefore be served and gut hormones are~     measured during the following 300 min.~   "
167992|NCT01366729|"~     Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30%~     remain unable to walk and up to 60% are left with moderate to severe walking disability.~      Evidence shows that rehabilitation techniques which emphasise use of the hemiplegic side~     influence ipsilesional cortical plasticity and improve functional outcomes. Canes are~     commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle~     activity. We have shown that an orthosis TheraTogs ( elastic corset supporting hemiplegic~     side) significantly increases hemiplegic muscle activity during gait.~      To date no clinical studies have investigated the long term effects of these techniques on~     gait recovery following stroke.~      This study aims to determine if advances in the understanding of cortical plasticity and its~     relation to functional recovery following stroke can be applied to clinical gait~     rehabilitation to improve long term outcomes.~      Hypotheses Early gait rehabilitation with canes will reduce hemiplegic muscle activity and~     inhibit balance reactions. In the long term this causes poorer walking ability and balance~     and consequently reduced social participation.~      Early gait rehabilitation with TheraTogs will increase hemiplegic muscle activity and~     facilitate balance reactions. In the long term this improves walking ability and balance~     leading to increased social independence and participation.~      Design Multi-centred, single blind, randomized control trial. Subjects 120 first time stroke~     patients Intervention When subjects can walk unaided on even ground whilst requiring verbal~     prompts and stand-by help without body contact (FAC 3) they will be randomly allocated into~     intervention (TheraTogs) or control (cane) group. TheraTogs will be applied to support hip~     extensor and abductor musculature according to a standardized procedure. Cane walking with~     cane at the level of the radial styloid of the sound wrist. Subjects will walk throughout the~     day with the assigned walking aid. Standard therapy treatments and usual care will remain~     unchanged and documented.The intervention will continue for five weeks or until patients have~     reached FAC 5 (independent walkers on all surfaces).~      Measures: the day before intervention begin, the day after intervention completion (max 5~     weeks), 3 months, 6 months and 2 years after completion Primary outcome Timed up and go~     test Secondary outcomes surface EMG of hemiplegic lower extremity musculature,~     temporo-spatial gait parameters, hip kinematics, dynamic balance. The Stroke Impact Scale.~      Results Significance levels will be 5% with 95% CI`s. ITT analyses will be performed.~     Descriptive statistics will be presented. Relevant co-variables will be identified and~     analysed. Discussion This study could have significant implications for the clinical practice~     of gait rehabilitation after stroke in particular the effect and appropriate use of walking~     aids~   "
167993|NCT01366716|"~     Contingency management (CM) is a demonstrably efficacious intervention for substance abuse~     and dependence. Although CM protocols have employed a variety of reinforcers, they have~     almost exclusively relied upon non-cash privileges (e.g., take-home methadone doses), prizes,~     or vouchers that can be exchanged for goods or services. Despite the strong empirical support~     for CM, our research suggests that concerns relating to its cost and safety (e.g., potential~     for harm caused by rewards undermining intrinsic motivation or being sold to purchase drugs)~     have hindered its transfer to real-world practice. The exclusive use of non-cash CM likely~     stems from the untested assumption that clients will use cash incentives to buy drugs or~     engage in other high-risk behaviors. This assumption is problematic for two reasons. First,~     the use of non-cash incentives may add substantial costs and complexity to CM protocols.~     Second, the use of non-cash incentives may reduce the efficacy of CM interventions, as~     research suggests that cash may be a more effective reinforcer than vouchers. This study~     examines both practical and ethical issues relating to cash-based CM procedures. This study~     consists of three phases; a main experiment, a Cash Bowl pilot, and a Thinning Pilot.~   "
167994|NCT01366703|"~     Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission~     for heart failure. New methods have been developed to continuously monitor arrhythmia's and~     heart failure parameters. One such method is implantation of an implantable loop recorder.~     Also home-monitoring is available for continuous monitoring and information sending to the~     treating physicians, with improving detection of atrial fibrillation (AF) and/or other sever~     arrhythmia's we hope to improve patient care.~      Objective of the study:~      To investigate the clinical efficacy in detecting clinically relevant arrhythmia's~     (especially AF) of the Reveal XT in patients with mild to moderate heart failure and elevated~     risk factor for stroke and transient ischemic attack (TIA)(CHADS-score >2), currently not~     treated with oral anticoagulation (OAC).~      Study design:~      In 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA class)~     2-3, a CHADS2-score>2 and no indication for a implantable cardioverter-defibrillator (ICD) or~     pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular outward~     clinic visits. The number of relevant arrhythmia's detected will count for the primary~     endpoint. Also the number of medication changes and institution of OAC.~      Study population:~      50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT~     implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known.~      Primary study parameters/outcome of the study:~      Primary endpoints~        -  AF burden and AF episodes detected~        -  Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias~          (VT's) or bradycardias~        -  % patients on OAC after 1 year follow-up~        -  Number of clinically relevant patient activated events~        -  Number of treatment policy changes based on the Reveal XT~      Secondary study parameters/outcome of the study~        -  specificity of AF detection algorithm by the Reveal~        -  Predictive value of the cardiac Compass data to predict worsening heart failure~          episodes.~   "
167995|NCT01366690|"~     The provision of HIV care and prevention services in resource-limited settings (RLS) entails~     substantial challenges due to a human resource crisis.[1] One strategy to address this human~     resource crisis is task shifting—the redistribution of tasks from higher trained providers to~     health workers with less training. Peer supporters, a group of community health workers who~     are people living with HIV (PLHIV), are an underutilized cadre to whom tasks can be shifted.~     Peers have been used extensively and effectively in HIV/AIDS programs in RLS, typically as~     peer educators who provide HIV prevention and education services.[2] Peers may be a potential~     source for not only providing care, but also impacting patient behaviors through peer~     counseling, education, and psychosocial support.~      With the scale up of HIV counseling and testing in RLS, increasing numbers of PLHIV know~     their serostatus and could potentially be engaged in care and prevention services. While~     antiretroviral therapy (ART) is a critical component of care which has been a source of much~     attention, PLHIV who are not yet on ART can also benefit from being engaged in care and~     utilizing other evidence-based health interventions besides ART. Also, many HIV/AIDS care~     programs have difficulty both retaining PLHIV in care prior to ART and initiating ART in a~     timely fashion. Additionally, many PLHIV not yet on ART still engage in risky sexual~     behaviors and do not fully utilize a proven basic preventive care package (BCP) set of~     interventions (cotrimoxazole prophylaxis, bed nets, and safe water systems). Peers may be~     able to impact PLHIV not yet on ART by improving linkages to care, facilitating timely~     initiation of preventive interventions and ART, and decreasing risky sexual behaviors.~     However, well-designed and evaluated operations research is needed to assess peer support~     effects on these care and behavioral outcomes.~      The objective of this study is to assess the impact of a peer support home visit intervention~     on patient engagement in care, utilization of a basic care package (BCP) of preventive care~     interventions, and risky sexual behaviors among people living with HIV (PLHIV) not on~     antiretroviral therapy (ART) through an individually randomized, operations research,~     community-based trial. We will compare outcomes between PLHIV who receive the peer-led~     intervention to those who do not. The primary outcomes will be engagement in care, BCP~     adherence, and condom use. The study hypotheses are as follows: (1) PLHIV who receive the~     peer intervention will have improved engagement in care compared to PLHIV not receiving the~     intervention; (2) PLHIV who receive the peer intervention are more likely to adhere to a BCP~     of interventions to prevent illness compared to PLHIV not receiving the intervention; (3)~     PLHIV who receive the peer intervention will have less risky sexual behaviors compared to~     PLHIV not receiving the intervention.~   "
167996|NCT01366677|"~     This study aims to provide novel information on the feasibility of yoga interventions for~     secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood~     states, fall risk and balance. This information will be important for determining safe,~     cost-effective and reliable practices for the benefits of yoga as an alternative means for~     improved health and well-being. A yoga intervention that is integrative and evidence-based~     will benefit the blind population through effective treatments and prevention of secondary~     symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in~     the future.~   "
167997|NCT01366664|"~     The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug~     has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60~     mg when concomitantly administered in participants taking terazosin.~   "
167998|NCT01366651|"~     The purpose of this study is to characterize the penetration of doripenem in the cerebral~     spinal fluid in pediatric patients <1 year of age who are hospitalized and have a documented~     or suspected infection and are planning to, or undergoing treatment with intravenous (IV)~     antibiotics.~   "
168001|NCT01366612|"~     This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan~     and low dose total body irradiation in patients undergoing allogeneic stem cell~     transplantation. A study population of 80 subjects will be enrolled from The John Theurer~     Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive~     allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will~     be consented and enrolled. Subjects will be randomly assigned to receive one of 2~     conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total~     body irradiation (TBI). Subjects will be followed until 1 year post transplantation to assess~     the relapse rate in each arm and transplant-related toxicity.~      The combination of fludarabine and busulfan is the current standard of care for patients with~     myeloid malignancies (AML, CML and other myeloproliferative disorders, or MDS) undergoing~     allogeneic transplantation at HUMC. In this study we will be comparing in a randomized~     fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.~   "
168002|NCT01366599|"~     Describe cardiovascular events in a cancer population receiving highly emetogenic~     chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).~   "
168003|NCT01366586|"~     The study aims to:~        1. Achieve molecular imaging of MG7 antigen in patients with gastric cancer in vivo using~          confocal laser endomicroscopy.~        2. Compare the results of in vivo MG7-specific molecular imaging with CLE and ex vivo~          immunohistochemistry .~   "
168004|NCT01366573|"~     The aim of the study is to assess the safety and tolerability of GSK1521498 in combination~     with alcohol and to determine the amount of GSK1521498 and alcohol in your blood after you~     have been given these together. The study will also determine whether GSK1521498 will have an~     effect on alcohol liking and consumption.~   "
168005|NCT01366560|"~     GSK962040 is a selective non-peptide motilin receptor agonist which is in development for the~     treatment of conditions associated with slow rates of gastric emptying. Single ascending~     doses (1 to 150 mg), and 14-days repeated doses (10 to 125 mg daily) have been investigated~     in two randomized, placebo-controlled trials. Results show that these doses were well~     tolerated with few mild to moderate adverse events (AE), and no clinically significant~     abnormal vital sign measurements, ECG changes or abnormal clinical laboratory findings.~     GSK962040 exhibited predictable PK with and without food. The mean within subject time for~     half a [13C]-containing meal to empty from the stomach (GE t½) decreased by 22-43% from~     placebo with GSK962040 50-150 mg single doses, and shortening of gastric emptying was~     confirmed at doses of 50 mg and above in the repeat dose study.~      Several studies have shown that motilin agonists increase lower oesophageal sphincter (LOS)~     pressure and have various dose dependent effects on oesophageal peristaltic amplitudes and~     propulsive contractions in both healthy volunteers and patients with gastro-oesophageal~     reflux disease (GORD). The purpose of the present study is to examine the effect of GSK962040~     on oesophageal function, using techniques such as high resolution oesophageal manometry, and~     pH/gastric transit using a wireless motility capsule.~   "
168006|NCT01366547|"~     Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in~     phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations~     (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of~     tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first line~     regimen due in large part to its convenient presentation as a full treatment regimen in a~     single product, other options are needed. A fixed-dose combination of DTG/abacavir~     (ABC)/lamivudine (3TC) is one such opportunity.~      This is a single-center, randomized, open-label, 3-period crossover study in healthy adult~     subjects to evaluate the single-dose relative bioavailability of two experimental oral DTG 50~     mg/ABC 600 mg/3TC 300 mg FDC tablet formulations compared to co-administration of the~     separate tablet formulations (DTG 50 mg tablet and EPZICOM), with each dose administered in~     the fasted state. Approximately 18 subjects will be enrolled and randomized to one of 6~     different treatment sequences. There will be a screening visit within 30 days prior to the~     first dose of study drug and a follow up visit within 7-14 days after the last dose. There~     will be a 7 day washout between doses in each treatment period.~      The following PK parameters for DTG, ABC and 3TC will be measured: area under the~     concentration curve from time zero (pre-dose) extrapolated to infinite time~     (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the~     time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration~     (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of Cmax~     (tmax), terminal phase half-life (t½), apparent clearance following oral dosing (CL/F) and~     apparent terminal phase volume of distribution (Vz/F).~   "
168007|NCT01366534|"~     This study will evaluate whether administration of two investigational malaria vaccines~     (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection~     against malaria infection as compared to protection induced by the 257049 vaccine alone. The~     study will also evaluate the safety and the immune response to the new combination of the two~     experimental malaria vaccines.~   "
168008|NCT01366521|"~     A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients~     with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of~     mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety,~     pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as~     safety/tolerability assessments will be collected throughout the study~   "
168009|NCT01366508|"~     GSK is planning to undertake two anti-obesity drug studies in the area of obesity. In~     addition to assessment by questionnaires, it would be of significant value to incorporate an~     objective non-interventional measure of cognitive or motivational processing associated with~     evaluating and responding to food stimuli. Obesity is associated with increased attentional~     bias to palatable foods. The aims of this protocol are two-fold, first to characterize Event~     Related Potentials (ERPs) of two common aspects of food stimuli relevant to eating disorders~     -presence of food and its palatability, and secondly, to assess the modulation of these ERPs~     by appetite. Following a successful completion of this study, it is the intention to use the~     paradigm developed in future studies in the area of obesity.~   "
168010|NCT01366495|"~     The investigators propose to conduct both a randomized trial of HIV testing in community~     corrections, and a randomized trial of linkage to HIV care for people with HIV recruited~     through community corrections (probation and parole).~   "
168011|NCT01366482|"~     The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the~     use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment~     with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone~     in patients with peripheral arterial disease.~   "
171479|NCT01320813|"~     The main objective is to compare 12 month complication rates between a new surgical method~     for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and~     open thyroidectomy.~   "
168012|NCT01366469|"~     The primary objective of this pilot study is to identify and quantify inflammatory and~     genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history~     of chronic obstructive pulmonary disease (COPD) undergoing elective coronary~     revascularization (CABG) to determine the risk of developing post operative respiratory~     failure. To achieve this objective, this proposal outlines the following specific aims:~      Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in~     patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at~     the time of intubation immediately prior to surgery and again upon skin closure immediately~     after the surgical procedure.~      Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with~     post-operative pulmonary complications defined as prolonged mechanical ventilation (> 24~     hours), pneumonia, and/or tracheostomy.~      Aim #3. To inform the development and implementation of a large pivotal trial which may~     impact clinical decision-making during the initial pre-operative outpatient assessment of~     COPD patients undergoing CABG.~   "
168013|NCT01366456|"~     The purpose of this study is to evaluate efficacy of Shingigu and Charcoal moxibustion~     scientifically and objectively.~   "
168014|NCT01366443|"~     Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately~     diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in~     clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method.~   "
168015|NCT01366430|"~     The purpose of this study was to compare the immediate efficacies of each treatment maneuvers~     in treatment of geotorpic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).~   "
168016|NCT01366417|"~     The primary objective of this study is to measure the antimicrobial effectiveness of~     ChloraPrep One-Step Frepp Applicator.~   "
168017|NCT01366404|"~     About 10,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for~     the natural history of coronary lesions at 2 year clinical and imaging follow-up.~   "
168018|NCT01366391|"~     Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2~     Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome,~     gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary~     syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation.~     In every day medical practice lower doses of Metformin are administered searching for the~     continuation of the treatment.~      However, there is no clinical study to support this assertion. The objective of this study is~     to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking~     daily doses of 1500mg and 1000mg.~   "
168019|NCT01366378|"~     This open-label study assesses the single-dose pharmacokinetics of intravenously-administered~     MNTX in healthy adult male and female subjects in the absence of, and in the presence of,~     orally-administered cimetidine.~   "
168020|NCT01366365|"~     This double-blind, randomized, two-cohort, placebo-controlled, parallel group study~     characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses~     and at steady-state during multiple dosing and assessed the effects of aging on the~     pharmacokinetics, safety and tolerability of MNTX.~   "
168021|NCT01366352|"~     This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal,~     healthy volunteers. Study treatment entailed single doses of two different formulations of~     MNTX tablets.~   "
168022|NCT01366339|"~     This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy~     volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of~     each active treatment group is further randomized to a second, replicate dose of MNTX, and~     the placebo group receives an additional placebo dose.~   "
168023|NCT01366326|"~     MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to~     evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC)~     injection for a period of seven days. Blood samples will be obtained at screening and for~     drug concentration data.~   "
168024|NCT01366313|"~     The aim of our study is to define the median effective analgesic doses (ED50) of paracetamol,~     morphine, and their combination and determination the nature of their interaction~     administered IV for postoperative pain after moderate painful surgery using up-and-down and~     isobolographic methods.~   "
168025|NCT01366300|"~     The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine~     infusion initiated and maintained during surgery, on propofol requirements during general~     anesthesia.~   "
168026|NCT01366287|"~     The primary purpose of this study is to estimate the relative bioavailability and food effect~     of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical~     studies.~   "
168027|NCT01366274|"~     This single-blinded randomized study aims to compare two methods of manual hyperinflation~     (protective - moderate tidal volumes with positive end expiratory pressure) and~     non-protective (large tidal volume and no positive end expiratory pressure) in ventilated~     acute trauma patients, to investigate the effect on inflammatory markers, lung compliance,~     oxygenation and sputum volume.~   "
168028|NCT01366261|"~     The purpose of our study was to compare the size and the quality of biopsy samples together~     with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in~     prospective, randomized fashion. The second aim was to compare safety and tolerability of~     both types of procedure, performed in local anesthesia with addition of intravenous sedation~     and analgesia.~   "
168029|NCT01366248|"~     This NIH-NCCAM funded epidemiologic research is being conducted as an observational~     prospective case-control study of the use of Complementary and Alternative Medicine (CAM) and~     Integrated Oncology (IO) and their effects on breast cancer patients in community settings.~      Hypothesis: IO services improve patients' quality of life and decrease cancer recurrence~     rates in breast cancer patients as compared to women with similar disease states and~     prognoses who do not receive IO care, and may or may not use CAM treatment on their own.~   "
168030|NCT01366235|"~     Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic~     differences of therapeutic effect of chloroquine and search the cause of these ethnic~     differences. For this purpose, chloroquine will be administered to four ethic groups of~     Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be~     measured. The result of this study will be helpful in finding more adequate dosing regimen of~     chloroquine in patients with malaria.~   "
168032|NCT01366209|"~     PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the~     Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study~     objectives are to confirm the treatment effect of pirfenidone compared with placebo on change~     in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary~     fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo~     in patients with IPF.~   "
168033|NCT01366196|"~     Acute pain management is challenging in patients after spinal fusions, particularly since~     most have taken analgesics for prolonged periods before choosing the surgical alternative.~     Many of these patients are either preoperatively or become after surgery narcotic dependent.~     In addition, the narcotic based anesthetic required for the procedure, may induce a~     postoperative hyper-analgesia which may be partially responsible for the acute postoperative~     pain which is refractory to traditional doses of narcotics. Both the persistent nociceptive~     and neuropathic pain which these patients experience and narcotic-induced hyper-analgesia is~     mediated via non-conventional neural pathways. It is for these reasons, that in these~     patients postoperative pain is refractory to narcotic treatment. Postoperative pain in this~     situation is best managed using a multimodal approach. This technique allows the application~     of a number of treatment modalities which maximize pain reduction and minimize treatment side~     effects.~      Pregabalin (Lyrica) has been shown to be effective in the treatment of neuropathic pain.~     Pregabalin has a similar mechanism of action as gabapentin. Notably it has a rapid consistent~     absorption, linear pharmacokinetics, and a low potential for pharmacokinetic drug~     interactions. Hence, pregabalin should be a beneficial addition to the multi-modal pain~     regimen after spinal surgery; particularly in narcotic tolerant patients who respond poorly~     to conventional narcotic analgesics after surgery.~   "
168034|NCT01366183|"~     This trial studies the chemotherapy toxicity on quality of life in older patients with stage~     I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or~     fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may~     help doctors plan better ways to treat cancer.~   "
168035|NCT01366170|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. it may also help doctors~     predict how patients will respond to treatment.~      PURPOSE: This research trial studies biomarker expression in tissue samples from young~     patients with anaplastic large cell lymphoma.~   "
168036|NCT01366157|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about changes that occur in DNA and identify biomarkers~     related to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research trial is studying protein biomarker levels in tissue samples from~     young patients with low-risk Hodgkin lymphoma.~   "
168037|NCT01366144|"~     This phase I trial studies the side effects and the best dose of veliparib when given~     together with paclitaxel and carboplatin in treating patients with solid tumors that are~     metastatic or cannot be removed by surgery and liver or kidney dysfunction. Veliparib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the~     growth of tumor cells either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving veliparib together with paclitaxel and carboplatin may~     kill more tumor cells.~   "
168038|NCT01366131|"~     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed~     to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin +~     bevacizumab therapy in patients with histologically or cytologically documented inoperable,~     locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.~   "
168039|NCT01366118|"~     The parameter that best correlates with 5 years disease-free survival (DFS ) in patients~     (pts) with localized rectal cancer (RC) is the pathological TNM staging (ypTNM) after~     chemo-radiotherapy (Ch-RT). DFS is 97% in pts with ypT0N0M0 = ypCR and 42% in pts with ypN +.~     Standard 5-FU Ch-RT achieves 15% of ypCR. The use of IMRT achieves a high proportion of ypCR~     . This study aimed to demonstrate in a prospective manner the feasibility of personalizing Ch~     regimen base in TT in combination with IMRT in patients with RC. Secondary objectives~     included the number of ypCR and safety.~   "
168040|NCT01366105|"~     In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid~     in wound healing along the lines of closure for lower extremity amputation and complex~     abdominal wounds. This study is designed to be a prospective, randomized clinical trial to~     evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these~     wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs.~     standard dressing) prior to surgery, and will be followed in the post operative period to~     monitor the effects on their surgical closures. The experimental group will consist of~     participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.) device~     placed intra-op along the line of closure. The control group will receive a standard surgical~     dry sterile dressing. The surgical closures will be assessed after three days of treatment as~     well as the first outpatient post-op visit and any subsequent visits through the following 6~     months. By doing so, the investigators hope to demonstrate the utility of NPWT on difficult,~     at risk surgical closures. Additionally, the investigators hope to show a difference in~     clinical outcome of incisions treated by NPWT over our current standard technique.~      All patients in the principal and co-investigators practice who are scheduled to undergo~     lower extremity amputation or complex abdominal closure will be eligible for enrollment in~     this prospective randomized study. There are no exclusion criteria. Informed consent will be~     obtained pre-operatively. Data collection will include basic demographic data, disease~     history, past medical and social history as well key data relating to wound healing~     (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative~     complications). The investigators will use simple statistical methods (ANOVA and chi-squared~     analysis) to compare surgical wound healing between the two populations. The only deviation~     from current standard of care in these populations includes utilizing a V.A.C. system on the~     closure line of the experimental group versus the standard dry sterile dressing.~   "
168041|NCT01366092|"~     Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord~     blood transplant. The donor's immune system may recognize the your body (the host) as foreign~     and attempt to 'reject' it. This process is known as graft-versus-host-disease. It is thought~     that IL-2 may help control chronic GVHD by stopping the donor's immune system from~     'rejecting' your body. In this research study, we are looking to see how IL-2 can be used in~     combination with steroids to treat cGVHD.~   "
168042|NCT01366079|"~     There was an only single operator study reporting dynamic position change during colonoscopy~     withdrawal significantly improved polyp and adenoma detection. So we designed a prospective,~     randomized multicenter study to verify the effect of dynamic position change in colonic~     adenoma detection. We think position change improve luminal distension and has the potential~     to improve adenoma detection rate.~   "
168043|NCT01366066|"~     During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in~     pressure was observed in the external urethral sphincter along with an increase in bladder~     capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve~     Stimulation (TMNS) in women could induce pressure increment of the external urethral~     sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33~     women suffering from urinary stress incontinence were able to contract their pelvic floor~     muscles and had become free of symptoms. Another pilot study has shown promising effect on~     the overactive bladder syndrome.~      The present study aims to treat urinary incontinence and includes 2 groups of patients with~     30 patients in each group: Women suffering from urinary stress incontinence and women~     suffering from urge incontinence. A medical vibrator is used and in each group the subjects~     will be randomized to vibration treatment or no vibration treatment. All patients will~     receive pelvic floor training and all women suffering from urge incontinence will receive~     anticholinergic medications.~      The stimulation will be performed at the perineum every day for 6 weeks with an amplitude of~     2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires,~     micturition diaries and diaper tests.~      If the investigators are able to demonstrate a significant reduction in the incontinence~     symptoms in the subjects the investigators asses that vibration can be a way of~     reestablishing a normal function of the pelvic floor muscles and bladder function in~     incontinent patients.~   "
168044|NCT01366053|"~     This Phase IV observational trial is intended to identify patients who are failing GnRH~     agonist therapy as evidenced by a rising PSA and who have yet to initiate secondary~     manoeuvres involving antiandrogens. This group may include both non-metastatic as well as~     metastatic patients. The trial will determine if these patients will benefit from switching~     to Degarelix. It will assess the effect of Degarelix's direct mode of action on androgen~     levels and whether continuous use of Degarelix improves disease progression.~      As per the CUA Guidelines for the Management of CRPC, because the androgen receptor remains~     active in most patients who have developed castration resistant disease, it is recommended~     that ADT should be continued (LEVEL 3, GRADE C). Therefore, it is logical to continue~     patients on Degarelix throughout the castrate resistant period. This will allow for the~     gathering of data that is currently unknown within this setting, such as the effect of~     combined treatment with antiandrogens as well as chemotherapy and other castrate resistant~     treatments.~   "
168045|NCT01366040|"~     This is an open-label, multicenter, survey-based study to determine subject satisfaction with~     using the single-use autoinjector for the delivery of AVONEX PS. Enrollment will consist of~     200 subjects in a single cohort who have been prescribed AVONEX PEN in accord with its~     Product Monograph. All subjects must be experienced AVONEX PS users (i.e., using it for at~     least 12 weeks without any support person to help with the injections administered in the~     vastus lateralis) and enrolled in MS AllianceTM program (hereinafter, MS Alliance). The~     clinic nurse investigator will instruct the patient on the correct method of using AVONEX PEN~     and the first injection with Autoinjector, using the subject's own supply, will be completed~     in the clinic, with the clinic nurse investigator present. All further injections of AVONEX~     PEN will be self-administered at home. The subjects will complete the first set of~     questionnaires, including Subject Satisfaction Questionnaire, Ease of Use Grading Scale and~     the Autoinjector Instructions Grading Scale, within 10 minutes after the first injection at~     the clinic, and will be given another set of questionnaires to be completed at home within 10~     minutes following the last study injection 2 months later, provided the subjects still~     continue to self-administer their AVONEX PEN. The first set of questionnaires will be left~     with the clinic nurse investigator to be sent to the CRO by fax or e-mail, while the second~     set will need to be mailed to the CRO by study subjects using the provided self-addressed,~     postage-paid envelope.~   "
168046|NCT01366027|"~     PBA is a neurologic condition that is estimated to impact over a million patients and their~     families in the United States. PBA occurs secondary to an otherwise unrelated neurologic~     disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of crying~     and/or laughing. Progress has been made in better understanding this debilitating condition,~     but much more needs to be done. That's why a new PBA patient registry, PRISM (Pseudobulbar~     Affect RegIstry Series), has been initiated.~      The goal of PRISM is to establish the prevalence and quality of life (QOL) impact of PBA in~     patients with underlying neurologic conditions including~        -  Alzheimer's disease~        -  Amyotrophic lateral sclerosis~        -  Multiple sclerosis~        -  Parkinson's disease~        -  Stroke~        -  Traumatic brain injury~      Because this is an observational registry, it doesn't require you to intervene with any~     specific treatment or procedure. Your participation allows the PRISM registry to collect and~     analyze data from your site and also compare it to national numbers captured in the PRISM~     registry about PBA across all of the major at-risk neurologic populations.~   "
168047|NCT01366014|"~     This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of~     investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe~     pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety.~     Approximately 150 patients from the US will be enrolled in this study.~   "
168048|NCT01366001|"~     The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when~     administered to opioid-experienced cocaine abusers.~   "
168049|NCT01365988|"~     Objective- To use fMRI to compare brain activity at rest and during memory and decision~     making tasks in normal children and in children exposed in utero to drugs of abuse.~      Study population- All participants will be 14-20 year-olds enrolled in an ongoing~     longitudinal follow up study of children exposed to drugs of abuse in utero funded by NIH. A~     subgroup of this study cohort will be invited to participate based on added criteria needed~     for scanning studies, such as absence of metal in the body, no significant CNS disease, and~     ability to tolerate the scanning environment.~      Design- Participants will undergo fMRI scans while performing a memory task, a decision~     making task and at rest. Data from participants in the current study may be combined with~     those from a previous study (NIDA protocol 417) which now reside in our repository protocol,~     8002 and NIDA protocol 455.~      Outcome measures- The primary outcome measures will be the difference in BOLD fMRI activation~     between drug-exposed participants and those without prenatal exposure to drugs of abuse.~   "
168050|NCT01365975|"~     Periconceptional folic acid supplements of 400 (Micro) daily prevent neural tube defects~     (NTD) in offspring. Some data suggest that periconceptional folic acid supplements, folate~     levels during pregnancy, and/or certain variants in the gene that encodes~     methylenetetrahydrofolate reductase (MTHFR), a key enzyme that catalyzes synthesis of~     5-methyltetrahydrofolate [the primary methyl donor in most metabolic pathways involving~     methylation including DNA methylation] from 5,10 methylenetetrahydrofolate may be associated~     with reduced risks of certain adverse events during the prenatal period, birth weight and~     certain serious diseases in offspring, while other studies have raised concerns about~     increased risks of specific serious disorders. Only one study has examined late health~     effects in mothers that might be associated with use of periconceptional folic acid~     supplements.~      We propose to study potential health benefits and adverse effects of periconceptional folic~     acid supplements in a 15-year follow-up of offspring and mothers. In the offspring, we will~     evaluate whether periconceptional folic acid supplements reduced risk of external congenital~     birth defects and childhood acute lymphoblastic leukemia, and whether risks are reduced or~     increased for other pediatric disorders linked with periconceptional folic acid supplements~     including asthma, pervasive developmental disorders and autism, diabetes, obesity and blood~     pressure. In the mothers, we will assess cardiovascular diseases and associated risk factors,~     breast and colorectal cancers and precursor conditions, and other cancers. We will also~     conduct exploratory assessment of other serious diseases in mothers.~      To increase the limited data on the morbidity and survival of children born with a major~     birth defect, particularly in low- or middle-income countries, we plan to assess morbidity~     and mortality outcomes in children identified with neural tube defects as part of our~     follow-up.~      The women and children who participated in the joint China-U.S. Community Intervention~     Program (CIP) trial (N=243,779 women treated or not treated with folic acid in the~     periconceptional period and their offspring) represent unique cohorts whose periconceptional~     exposure to folic acid is well documented. We propose to follow a sample of 22,000 CIP~     mothers and their offspring (currently 14 to 17 years of age), to ascertain vital status,~     medical history, and lifestyle habits. The study will clarify whether there are differences~     with respect to growth, physical development during the puberty period, selected serious~     morbidity and mortality in offspring and risks of serious health outcomes and mortality in~     mothers associated with periconceptional folic acid supplements. Data from this study will~     inform us about cohort participation rate, cost, and effective approaches for future~     follow-up of the full cohort.~      The current protocol focuses on a pilot study (Pilot Study # 1) in which we will carry out~     two specific aims in 500 families. We will test and evaluate the most effective approaches to~     trace the mothers who enrolled in the CIP in 1993-1995 in CIP counties, fathers, and~     children. If the child is not living with the biological mother, we will trace the caretaker~     or next of kin with whom the child is living. We will also conduct in-person interviews,~     obtain anthropometric and blood pressure measurements and determine cohort participation rate~     in a sample of 500 CIP families from two of the 21 CIP project counties to obtain health~     information, medical history, and vital status. We will attempt to enroll in the pilot study~     500 mothers/caretakers and 500 offspring, and 500 fathers (Total N=1500). Excluded from the~     Pilot Study #1 at this time are the families in which the mother or the child is deceased. We~     will seek permission from the IRB to enroll these families at a later date.~   "
168051|NCT01365962|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with~     rhabdomyosarcoma.~   "
168052|NCT01365949|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in tissue samples from patients with Ewing~     sarcoma.~   "
168053|NCT01365936|"~     There have been some controversies regarding the use of preparations with LH activity in~     patients with polycystic ovary syndrome (PCOS) who have high endogenous LH activity. In this~     research we aimed to compare urinary menotrophin versus recombinant FSH (rFSH) with respect~     to the prevention of OHSS~   "
168054|NCT01365923|"~     During recovery from general anesthesia the stimuli of endotracheal tube lead to the~     coughing, hypertension, tachycardia, which can cause a serious complication. Especially the~     postoperative course of patients emerging from general anesthesia after intracranial surgery~     is frequently complicated by the occurrence of hypertension and coughing event.~      It has been demonstrated that opioid, intravenous or topical lidocaine administration can~     attenuate the coughing reflex. Administered the opioid before emergence, it is effective to~     prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.~      However, remifentanil is an opioid widely used because of rapid context-sensitive half-life,~     target-controled infusion method to adequately maintain the effect site concentration could~     help to predict the recovery time to the alert state from the general anesthesia. It is~     considered proper method of continuous infusion of remifentanil for reducing emergence cough.~      Dexmedetomidine , a potent alpha adrenoceptor agonist which dose-dependently reduces arterial~     blood pressure and heart rate, decreases the hemodynamic and and catecholamine response to~     intubation and extubation. It is thus theologically appropriate for reducing airway and~     circulatory reflexes during emergence from anesthesia.~      In this study, the investigators used bolus dexmedetomidine immediately before extubation,~     and compared the effects on coughing, hemodynamic response and recovery profile to a~     continuous infusion of remifentanil.~   "
168055|NCT01365910|"~     This phase II trial studies how well Linifanib works in treating patients with advanced,~     refractory colorectal cancer expressing k-Ras mutations. Linifanib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
168056|NCT01365897|"~     The purpose of this study is to determine whether modafinil is effective in the improvement~     of mnesic performance and executive functions of university students from high academic~     performance.~   "
168057|NCT01365884|"~     Proof of concept study to compare the best corrected visual acuity obtained via First-Sight~     lenses with the autorefraction in children.~   "
168058|NCT01365871|"~     The current standard for pain relief during prostate biopsy is the injection of local~     anesthetic agents into or around the prostate at various sites including apex, base, lateral~     aspects and into the prostate itself. Despite such anesthetic injection, some men still~     experience severe pain and often at the base of the penis. The study audits current practices~     comparing the degree of pain relief provided by injection at basal versus basal+apical sites.~     All these injection sites are standard practice at our hospital.~   "
168059|NCT01365858|"~     -  Background : The general experience with the Virtual Reality application approach~          suggests that this treatment concept is promising in stroke rehabilitation~        -  Purpose : In shopping activity in a real supermarket and in simulated with the~          investigators virtual shopping simulation (VAP-S = virtual action planning supermarket),~          the investigators will compare people who had undergone a stroke who receive~          conventional rehabilitation or virtual training in VAP-S.~   "
168060|NCT01365845|"~     The purpose of this study is to determine if proton radiation therapy will reduce the amount~     of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of~     any cardiac side effects.~   "
168061|NCT01365832|"~     C-reactive protein (CRP) is directly implicated in atherogenesis and associated~     cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective Continuous~     Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease CRP levels and~     thus consequently improve disease-related cardiovascular morbidity. However, the influence of~     gender on the CRP evolution pattern has never been assessed before. The aim of our study was~     to investigate possible gender differences in CRP evolution in OSA patients 3 and 6 months~     after the start of effective CPAP treatment.~   "
168062|NCT01365819|"~     Methamphetamine (MA) dependence is a source of continuing danger for both individuals and~     society. While there are some behavioral treatments, they are not always effective. To date,~     there are no medications available to treatment methamphetamine dependence. There is some~     early evidence suggesting that varenicline (also known as Chantix(tm)) may help people to~     stop or reduce their use of methamphetamine. Varenicline is already on the market in the U.S.~     for cigarette smoking cessation and shows promise for treating alcohol dependence. In order~     to determine if varenicline can help people stop using methamphetamine, we will enroll 90~     methamphetamine-dependent people who are looking for treatment into the study at the UCLA~     Vine Street Clinic operated by Dr Shoptaw of UCLA. Half will receive varenicline (n=45) and~     half will receive placebo (n=45) which will be determined randomly. Everyone will receive~     talk therapy for methamphetamine dependence. People will take the medication for 9 weeks~     followed by a 4 week follow-up period. Before receiving any medication, participants will~     complete a maximum 2 week (6 study visits) lead-in to complete baseline assessments,~     psychological and medical evaluation, and comprehensive assessment of drug use to determine~     study eligibility. If a person is eligible for the study, s/he will receive either~     varenicline or placebo. Participants will visit the UCLA Vine Street Clinic (UCLA VSC) three~     times a week study visits. At the end of the medication phase, subjects will complete a four~     week follow up period for safety monitoring.~   "
168085|NCT01365507|"~     This trial is conducted in Asia and North America. The aim of this trial is to compare the~     efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve~     subjects with type 2 diabetes mellitus when using two different titration algorithms (dose~     individually adjusted) as add-on to subject's ongoing treatment with metformin.~   "
168063|NCT01365806|"~     The long-term goal of this research is to apply novel technology for detection of donor organ~     (allograft) rejection to improve patient outcomes following heart transplantation. The~     specific goal of this study is to determine whether daily monitoring of the transplant~     recipient's electrocardiogram (ECG) using a simple home device with transmission to an ECG~     Core Laboratory would provide an early biomarker for acute rejection. Despite routine~     immunosuppressant drug therapy, acute rejection is common, especially within the first 6~     months following transplant surgery. To detect rejection, frequent endomyocardial biopsies of~     heart tissue are performed. An endomyocardial biopsy is a costly and invasive procedure~     performed in a hospital cardiac catheterization laboratory that has associated risks. Recent~     evidence suggests that acute allograft rejection causes delays in ventricular repolarization~     resulting in a longer QT interval on the ECG. The specific aims of the study are to: 1)~     determine whether an increase in the QT interval during the first 6 months following heart~     transplant is a sensitive and specific biomarker for acute rejection; and 2) determine the~     timing of QT interval increases relative to biopsy-diagnosed stages of mild/moderate/severe~     rejection. The potential benefit of finding a simple ECG biomarker of allograph rejection~     that could be measured at home is that it might yield earlier detection of rejection, allow~     more timely therapy and reduce mortality from acute allograft rejection.~   "
168064|NCT01365793|"~     The investigators will conduct a randomized controlled trial comparing four different~     intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA). Two~     rates of rehydration will be compared; a more rapid rate and a slower rate. Within each of~     these two basic rehydration protocols, the investigators will vary the type of rehydration~     fluid used (0.9% saline or 0.45% saline). The investigators will compare the different~     treatments by conducting assessments of neurological injury, by measuring the frequency of~     significant cerebral edema, and by measuring long-term neurocognitive function.~      These studies will allow us to determine whether variations in IV fluid treatment protocols~     affect acute neurological outcomes of DKA. Additionally, they will provide important data~     regarding the impact of DKA and DKA treatment on long-term neurocognitive function in~     children. In this way, the investigators hope to identify a more ideal fluid management~     strategy for children with DKA.~      Previous studies have suggested that DKA may cause blood flow to the brain to be reduced and~     that brain injury might result from this reduction in blood flow and/or the effects of~     re-establishment of normal blood flow during DKA treatment with insulin and iv fluids. The~     investigators hypothesize that more rapidly re-establishing normal blood flow to the brain~     during DKA, by giving fluids more rapidly and using fluids with a higher sodium (salt)~     content, will help to minimize brain injury caused by DKA.~   "
168065|NCT01365780|"~     This project is meant to show wether the HBOT can fasten the recovery process after surgical~     treatment of distal Radius fractures. For this propose the microcirculation is measured,~     together with the level of pain on a visual analog scale (VAS) and the remaining force of the~     hand after surgery is examined. Furthermore the sonography with contrast medium which is long~     established for examination of organs of the parenchyma, is meant to be verified at the~     muscular-skeletal system in this project.~   "
168066|NCT01365767|"~     The purpose of this study is to determine how relevant dynamic ultrasound scans using~     contrast agents (SonoVue) is in the diagnosis of Crohns disease in the small bowel, compared~     to dynamic Magnetic Resonance Imaging (MRI) of the small bowel.~   "
168067|NCT01365754|"~     The purpose of this study is to compare posterior dynamic stabilization with fusion in the~     treatment of lumbar degenerative disease.~   "
168068|NCT01365741|"~     The purpose of the study is to clarify wether body posture during ingestion of 60mg Efient, a~     thrombocytic inhibitor, has influence on the time to thrombocytic inhibition.~      The study aims to mimic the treatment Danish patients receive when admitted to the hospital~     with a ST-elevation myocardial infarction since these patients are refereed to acute~     Percutaneous Coronary Intervention (PCI) necessitating fast and efficient thrombocytic~     inhibition.~      Current guidelines recommend the administration of Efient right before the PCI procedure,~     while the patient is lying down, either in the ambulance or in the operating room. We, the~     investigators, believe that this is suboptimal for the patient, since any sort of prolonged~     inhibition time will possibly worsen the patients prognosis and make the patient more prone~     to later clotting issues.~      Our hypothesis is that by making the patients ingest the tablets in a 90 degrees upright~     position and making them sit up for 2 minutes after ingestion, the effect of the pills will~     commence faster than if taken in a supine position. This will possibly lead to faster~     inhibition of the thrombocytes, which we believe will lead to a lower incidence of clotting~     issues during and after the procedure.~   "
168069|NCT01365728|"~     The purpose of the study is to compare the results of LASIK surgery when using two versions~     of a femtosecond laser in patients with nearsightedness with and without astigmatism.~   "
168070|NCT01365715|"~     The main purpose of this study is to assess the efficacy of preoperative embolization in~     decreasing operative blood loss, decreasing the need for intraoperative transfusion and~     facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at~     describing the vascularity in a series of spinal metastasis, and to correlate this with~     perioperative blood loss.~   "
168071|NCT01365702|"~     The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow~     obstruction due to Tuberculosis (TB) destroyed lung.~   "
168072|NCT01365676|"~     2 phytomedicines already in the market: GAMALINE® for premenstrual syndrome and HIPERICIN® as~     antidepressant will be prescribed together for treating women with Premenstrual Syndrome~     (PMS) symptoms and vasomotor problems for checking the advantage compared to the GAMALINE®~     prescription alone.~   "
168073|NCT01365663|"~     The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.~   "
168086|NCT01365494|"~     This study was planned to establish the non-inferiority of Rabipur administered as simulated~     post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult~     subjects.~   "
168087|NCT01365481|"~     The purpose of this study is to assess the long-term safety and tolerability profile of~     valsartan and valsartan-based treatments in children with hypertension, with or without~     chronic kidney disease.~   "
171870|NCT01315665|"~     The purpose of this study to investigate the effect of sulforaphane from macerated broccoli~     sprouts in humans and to evaluate less invasive methods of assessing potential~     anti-inflammatory drugs in CF.~   "
168074|NCT01365650|"~     This was an open label, three way study in participants with symptomatic allergic rhinitis.~     The following 3 treatments were administered to each subject during dosing periods 1, 2 and~     3, respectively:~        -  Treatment A: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray~          into each nostril) on Day 1 of Period 1.~        -  Treatment B: Single intranasal dose of oxymetazoline hydrochloride followed by a single~          intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30~          minutes later on Day 1 of Period 2.~        -  Treatment C: Seven days of treatment with intranasal fluticasone propionate (between~          Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine~          (one 15 mg spray into each nostril) on Day 1 of Period 3.~      Subjects remained resident in the Clinical Unit from Day 1 until the morning of Day 2 in each~     period and there was a washout period of 2 to 7 days between periods. A post study medical~     was performed within 7 days of Period 3.~      The objectives of this study were:~        -  To assess the pharmacokinetics (PK) of intranasal ketorolac in participants with~          symptomatic allergic rhinitis.~        -  To assess the effects of a single dose of intranasal oxymetazoline hydrochloride on the~          pharmacokinetics and tolerability of intranasal ketorolac in participants with~          symptomatic allergic rhinitis.~        -  To assess the effects of chronic administration of fluticasone propionate on the~          bioavailability and tolerability of intranasal ketorolac in participants with~          symptomatic allergic rhinitis.~   "
168075|NCT01365637|"~     The purpose of the study is primarily to determine the safety and toleration and~     pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days.~     Dosing will either be administered twice or three times daily. Secondary objectives will be~     to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on~     the PK of PF-05089771.~   "
168076|NCT01365624|"~     This study had an open-label, single-dose design. All subjects received a single dose of 30~     mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were~     obtained pre-dose and at specified time points over 24 hours post-dose.~      The primary objective of this trial was to compare the pharmacokinetics of intranasal~     ketorolac between elderly and nonelderly adult subjects. The secondary objective was to~     evaluate the safety profile of intranasal ketorolac in elderly subjects.~   "
168077|NCT01365611|"~     This was a non-randomized, open label study in healthy male and female volunteers. A single~     intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1~     and 6; in addition, subjects received a daily intranasal dose of 200 µg fluticasone~     propionate on Days 2-6. Subjects remained resident in the Clinical Unit from the evening of~     Day 1 until the morning of Day 2 and from the evening of Day 5 until the morning of Day 7,~     and made ambulatory visits to the Clinical Unit on the morning of Days 3-5. A post study~     medical was performed within 7 days of study completion.~      The objective of this study was to assess the effects of chronic administration of~     fluticasone propionate on the pharmacokinetics of intranasal ketorolac in healthy male and~     female subjects.~   "
168078|NCT01365598|"~     The purpose of this study is to evaluate the safety and efficacy of lower doses of primaquine~     compared to the dose recommended by the WHO for reducing P. falciparum gametocytes in the~     infected human host to prevent transmission of falciparum malaria to the anopheles mosquito~     vector.~   "
168079|NCT01365585|"~     The objective of this observational study is to gain clinical insight on the actual use of~     sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The~     primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three~     times daily for the treatment of PAH.~   "
168080|NCT01365572|"~     The purpose of this study is to evaluate the feasibility, safety, and effectiveness of~     EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following~     drug-eluting stent (DES) implantation. The investigators will evaluate clinical, angiographic~     and intravascular ultrasound (IVUS) assessment of 9-month efficacy of EndeavorTM ResoluteTM~     or Xience VTM implantation in DES restenosis and assess the vascular changes of re-treatment~     with DES for DES restenosis using follow-up IVUS analysis. In addition, the investigators~     will evaluate the effectiveness of retreatment with EndeavorTM ResoluteTM or Xience VTM stent~     implantation in patients with restenosis after DES~   "
168081|NCT01365559|"~     This is a phase I/II multicenter, open label, nonrandomized study for patients with Multiple~     Myeloma (MM) who will receive treatment with carfilzomib in place of bortezomib using the~     same bortezomib-containing combination regimen to which a MM patient has progressed while~     receiving. This study will enroll 45 patients total. These patients will be resistant to~     bortezomib as demonstrated by progressive disease while on bortezomib or have relapsed within~     12 weeks of the last dose of bortezomib in a combination regimen. Patients will be~     sub-divided into 2 groups in this study, treatments containing (Group A) or not containing~     immunomodulatory drugs (IMiDs) (Group B). Thirty patient will be enrolled into Group A and 15~     patients into Group B for a total of 45 patients. Patients must have received 4 doses of a~     minimum of 1.0 mg/m^2 of bortezomib in no more than 4 weeks per cycle. Patients must have~     received at least one cycle meeting this definition and have shown progressive disease to be~     considered eligible. Patients who have been refractory to or relapsed within 12 weeks of the~     last dose of bortezomib in their most recent bortezomib-containing regimen that does not~     include either thalidomide or lenalidomide are eligible regardless of when patients received~     that regimen, as long as they meet the above criteria.~      Carfilzomib will subsequently replace bortezomib using the patient's most recent~     bortezomib-containing regimen to which the patient progressed while receiving. Patients will~     be eligible if they progressed from bortezomib with an alkylating agent (melphalan or~     cyclophosphamide), an anthracycline (doxorubicin or pegylated liposomal doxorubicin) and/or a~     glucocorticosteroid (prednisone, dexamethasone or medrol)and IMiD (thalidomide or~     lenalidomide). The study will consist of a screening period, followed by up to eight open~     label treatment cycles, a final assessment to occur 28 days after the end of the last~     treatment cycle, a follow-up period and maintenance cycles of single agent carfilzomib.~      Patient who complete the combination treatment period without progressive disease will be~     eligible for maintenance therapy with single-agent carfilzomib. During maintenance therapy~     carfilzomib will be administered at the same dose given during the last cycle of combination~     treatment.~   "
168082|NCT01365546|"~     Proportion of surgeries in which the primary endpoint (overall assessment) is classified as~     success.~   "
168083|NCT01365533|"~     The study was a double-blind, placebo-controlled, crossover study to evaluate the efficacy of~     roflumilast on airway inflammation and function in patients with allergen-induced asthma.~      Individuals with stable, mild to moderate allergic asthma, with a history of episodic wheeze~     and shortness of breath, were eligible for enrollment.~   "
168084|NCT01365520|"~     This trial is conducted in Asia and Europe. The aim of the trial is to investigate the~     pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single~     dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A.~     Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part~     B) (NCT00840086).~   "
168113|NCT01365130|"~     The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety~     and side effects for patients with advanced gastroesophageal cancer~   "
168088|NCT01365468|"~     This study was to evaluate the antitumor activity and safety of RAD001 in patients with~     Plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).~      The aim of the study was to :~        1. determine whether RAD001, administrated orally daily on a continuous dosing schedule~          might:~             1. Increases time to disease progression (TTP) based on volumetric MRI measurements in~               children and adults with NF1 in inoperable documented progressive PN (stratum 1).~             2. Results in objective radiographic responses based on volumetric MRI measurements in~               children and adults with NF1 and inoperable PN in the absence of documented~               radiographic progression at the trail entry (stratum~        2. To evaluate the tolerability and toxicity of chronic RAD001 administration in this~          patient population as assessed by the NCI Common Toxicity Criteria, version 4.0.~   "
168089|NCT01365455|"~     This study will assess the safety and efficacy of secukinumab compared to placebo in patients~     that have moderate to severe, chronic, plaque-type psoriasis.~   "
168090|NCT01365442|"~     The purpose of this study is to provide evidence for policymakers and key opinion leaders on~     the pilot implementation of cholera vaccination using the newly licensed Oral Cholera Vaccine~     (OCV) in India. The pilot introduction will provide the evidence for the feasibility, costs~     and population acceptance of large-scale cholera vaccination using the Indian vaccine (using~     vaccination coverage rates and other measures).~   "
168091|NCT01365429|"~     Human donor lungs that do not meet the standard clinical criteria for donor lung utilization~     but fit into the study inclusion criteria will be retrieved from the donor using current~     donor lung retrieval techniques.~   "
168092|NCT01365416|"~     The prevalence of morbid obesity (BMI > 40 kg/m2) is increasing rapidly in the UK, but the~     investigators lack a coherent strategy for detailed assessment and treatment of the~     individuals affected, who are at high risk of morbidity and early mortality. The~     investigators already know that more than 1 in 20 severely-obese individuals have a simple~     genetic cause of their obesity (usually inherited in an autosomal dominant pattern. Bariatric~     surgery is the most effective treatment for morbid obesity and certain surgeries can result~     in the remission of type 2 diabetes. However, some patient fail to achieve the weight loss or~     experience complications and re-operations. The investigators are unable to predict the~     outcomes of bariatric surgery particularly in relation to type 2 diabetes remission which is~     crucial for the assessment of risk to benefit balance before wider future applications of the~     surgery.~      The investigators want to investigate the mechanism underlying Type 2 diabetes remission~     after bariatric surgery by A) examining the effect of Mendelian forms of obesity and diabetes~     on T2D remission, B) studying changes in expression profiling patterns in insulin-responsive~     tissues, C) identifying of eQTLs, and of other genetic variations affecting T2D remission and~     D) studying the role of epigenetic variation in T2D remission.~   "
168093|NCT01365403|"~     This open-label, fixed sequence, two-period study will assess the effect of multiple dose~     carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a~     single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of~     3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose~     of RO4917838 on Day 16.~   "
168094|NCT01365390|"~     The aim of this study is to provide baseline acute otitis media data in East European~     countries.~   "
168095|NCT01365377|"~     Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk~     factors are known: disease severity, age, gender. Another risk factor is lack of information~     from the medical staff and nurses.~      Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS).~     Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R)~     is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey~     (SF-36) is an assessment of life quality.~      In the following study, the investigators will evaluate the impact of a brochure as~     complement of oral information on Anxiety developed by relatives and family of ICU patients.~      The medical and surgical ICU is composed by two different units (different medical and nurse~     team, different location in the same hospital) of 12 beds on one side, 14 beds on the other~     side.~      During a year, in the first unit, the investigators will use the booklet as support and~     complement of oral information : booklet arm. The information process will be as usual in~     the other unit : control arm. During the second year, the booklet will be used in the~     second unit while the first unit will return to the usual oral information (cross-over).~      For each included patient, one relative or family member is pointed to be the referring~     family member or referent. This referent receives the HADS questionnaire at Day 3 after~     admission, at day of discharge if the patient is alive, at one month after discharge. The~     IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36~     questionnaire is given to the referent and the living patient at day 30. The day 30~     questionnaires are send by mail at the referent address.~   "
168096|NCT01365364|"~     Restless legs syndrome and periodic limb movement (PLM)are sleep-related movement disorders~     and studies have shown changes in striatal dopaminergic activity in patients with these~     disorders. Physical exercise has been shown to improve the symptoms of restless legs syndrome~     and PLM, as has treatment with dopamine agonists. However, the mechanism by which physical~     exercise acts as a non-pharmacological treatment in improving symptoms of restless legs~     syndrome and PLM remains unknown. The investigators evaluated dopamine transporter density~     profiles in 16 sedentary patients (control and experimental - with PLM, groups) and the~     influence of acute physical exercise on its concentration after a maximal exercise test. Each~     patient underwent baseline polysomnography to evaluate sleep patterns and PLM index values.~     After obtaining the polysomnography baseline, the single photon emission computer tomography~     baseline was determined. Subsequently, the volunteers performed a maximal exercise test in~     the morning, followed by a single photon emission computer tomography two hours later and~     polysomnography that night, to assess the effect of acute physical exercise on dopamine~     transporter and sleep patterns. The results showed significant lower dopamine transporter~     baseline densities in the striatum region for the experimental group. The results also showed~     a significant reduction in the periodic leg movement rate in the experimental group and a~     significant increased percentage of stage-1 non-REM sleep in both groups after maximal~     exercise test. Significant differences between the groups were only observed for Stage 2~     sleep and slow wave sleep. Our results show that patients with PLM had a lower dopamine~     transporter density in the left putamen region compared to the control group and an acute~     physical exercise (maximal exercise test) did not alter this profile, providing evidence that~     this improvement is the result of chronic physical exercise.~   "
168097|NCT01365351|"~     The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary~     short stature in children with insufficient growth hormone production and/or short stature~     caused by Turner syndrome.~   "
168098|NCT01365338|"~     This study aims to determine whether the drug affects brain activity in healthy volunteers,~     either when the participants are performing a memory task, or when lying at rest. Subjects~     will undergo a brain scan under both of these conditions after a dose of either the study~     drug or a placebo is administered.~   "
168099|NCT01365325|"~     The aim of the study is to compare two different home monitoring care programs in patients~     with chronic heart failure in functional class NYHA III, one of them based on clinical and~     electrocardiographic evaluations, the other one using also periodical handled~     echocardiographic examinations.~   "
168100|NCT01365312|"~     Appropriate delivery of adequate nutrition and medications in premature infants often~     requires central venous access in the form of a special IV called a PICC (peripherally~     inserted central catheter). While a necessary feature of neonatal intensive care, PICCs pose~     significant risk: among the most serious of these is infection. One common, successful~     infection control practice used in older children and adults involves the use of a lock, in~     which a fluid-filled syringe is attached to the end of an IV when it is not in use in order~     to prevent and/or treat clotting or infection. The solution is left for some period of time~     and is then either withdrawn from the line or flushed into the patient. The solution could be~     saline, antibiotics, other antiseptics, or any combination of these. However in the premature~     infant, use of antibiotics as a locking compound risks leaving behind organisms resistant to~     treatment; antiseptics can irritate vessels and cause breakage to sensitive premature skin;~     saline has neither sterilization nor anti-infective properties. By contrast, ethanol~     neutralizes or kills most bacteria, viruses, and fungi without the risk of resistance, and~     because it is not externally applied there is no risk to baby skin. Ethanol-based lock~     protocols have been used safely and effectively in both adult and pediatric populations~     without adverse effects, but this has not been tested in premature babies because fluids and~     medication are delivered continuously: placement of a lock traditionally requires an extended~     pause (hours or days) in fluid and medication administration.~      To overcome these key limitations, a periodic, brief ethanol lock protocol was designed such~     that both infant exposure and interruptions to fluid and medication delivery would be~     minimized. The lock is practical, cheap, easy to place, and takes advantage of an existing~     daily pause during which IV tubing and fluids hooked up to the PICC are changed. The~     objective of this study is to test the hypothesis that use of a 70% ethanol lock, every 3rd~     day, for 15 minutes, will safely and effectively reduce PICC infection in our unit.~   "
168101|NCT01365286|"~     The purpose of this study is to investigate heart rate lowering efficacy and respiratory~     safety of ivabradine in patients with asthma and COPD.~   "
168102|NCT01365273|"~     This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5~     centres in the US with deep-partial of full thickness burns in need of skin grafts will be~     enrolled.The subjects will be equally randomised to either treatment with Mepitel One or~     bridal veil together with staples.~      The primary objective is to compare pain at the time of dressing change for the use of~     Mepitel One versus bridal veil together with staples on deep partial or full thickness burns~     requiring skin grafts.~   "
168103|NCT01365260|"~     The purpose of this study is to determine whether MM-II is effective in the treatment of~     osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.~   "
168104|NCT01365247|"~     This treatment intervention trial is designed for men and women with substance dependence and~     comorbid Post-Traumatic Stress Disorder (PTSD). Participants will be randomly assigned to one~     of three conditions (two behavioral treatments [Concurrent Treatment of PTSD and Substance~     Use Disorders Using Prolonged Exposure and Relapse Prevention Therapy] and an active~     monitoring control group) and will be evaluated at baseline and four follow-up points~     (post-treatment, 1-month, 2- month and 3-month post-treatment).~   "
168105|NCT01365234|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. When there are~     changes in the heart beat sometimes an implantable heart device is used to control the rate~     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of~     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may~     be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the~     upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles~     through three leads (flexible insulated wires) that are inserted through the veins to the~     heart. The purpose of this study is to evaluate a new lead for delivering energy to the left~     ventricle (bottom left chamber of the heart).~   "
168106|NCT01365221|"~     The primary objective of this study is to compare platelet reactivity between patients~     receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients~     receiving only a loading dose of prasugrel.~   "
168107|NCT01365208|"~     The combination of pEBV DNA (half-life) and PET-CT following 1 course of chemotherapy allow~     earlier and more detection of drug response in advanced NPC than RECIST method, in patients~     with previously untreated advanced NPC who will receive platinum-based chemotherapy. This~     study will also determine if this new method can predict survival in these patients. This~     study may have far-reaching impact on drug development in NPC as it may offer a more optimal~     way of evaluating drug efficacy in clinical trials and also in clinical management.~   "
168108|NCT01365195|"~     The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic~     adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management~     and on the later recovery after surgery in patients undergoing colorectal surgery.~   "
168109|NCT01365182|"~     This intervention program combines biofeedback PFME with a telephone or support group~     intervention to treat persistent urinary incontinence (UI). The study's primary aims are to~     improve continence, quality of life, and mood through enhancing adherence to PFME and~     self-management of incontinence symptoms. The secondary aims are to examine the physiological~     effects and cost effectiveness of the proposed interventions.~   "
168110|NCT01365169|"~     The goal of this study of this study is to test the acceptability and usefulness of certain~     home-based health care devices for people who have been diagnosed with pancreatic cancer or~     other abnormal growth of tissue in the pancreas.~      This is an investigational study. Up to 50 patients who are scheduled to have pancreatic~     surgery will take part in the pancreas study. The pancreas study is one of many smaller~     studies that, when added together, will enroll up to 290 participants at MD Anderson.~   "
168111|NCT01365156|"~     The goal of this clinical research study is to learn if a surgical procedure called an~     extraperitoneal laparoscopic lymphadenectomy followed by chemotherapy and tailored radiation~     therapy can help to control the disease for a longer time than standard-of-care chemotherapy~     and whole pelvic radiation therapy.~   "
168112|NCT01365143|"~     To date, no study has prospectively compared open versus robotic radical prostatectomy in a~     randomized fashion for patients with prostate cancer. For patients with newly diagnosed~     prostate cancer who choose surgical management, the choice of surgical approach is often~     limited to surgeon preference and experience. This study will prospectively randomize~     patients with localized prostate cancer who are candidates for surgical management to open~     versus robotic radical prostatectomy.~   "
168116|NCT01365091|"~     To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin,~     5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with~     saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted~     and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin~     in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and~     metformin, 1000-mg XR tablets administered together in both the fasted and fed states.~   "
168117|NCT01365078|"~     Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation can reduce the~     risk for coronary heart disease. EPA can be synthesized from α-linolenic acid (ALA or~     C18:3n-3), but conversion is low. It has been suggested that the rate-limiting step for this~     conversion is the Δ6-desaturation of ALA into stearidonic acid (SDA or C18:4n-3). Thus,~     providing oils rich in SDA may increase the endogenous synthesis of EPA. This may~     subsequently lower serum triacylglycerol concentrations, an effect frequently observed after~     EPA supplementation, especially in people with increased triacylglycerol levels.~      The objective is to study the effects of echium oil, rich in SDA on serum triacylglycerol~     concentrations in healthy overweight and slightly obese men and women. The minor objective is~     to study the effects of echium oil on the omega-3 index, which is negatively related to~     cardiovascular risk and defined as the proportion of EPA and DHA in red blood cells.~   "
168118|NCT01365065|"~     The objective of the study is to assess the safety and ability of vorinostat, a drug~     currently licensed for the treatment of a type of lymphoma, to 'turn on' dormant HIV infected~     CD4 T-cells.~   "
168119|NCT01365052|"~     The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and~     diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to~     placebo (capsules containing no drug) when taken for 10 days.~   "
168120|NCT01365039|"~     This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact~     lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by~     current soft contact lens wearers on a daily disposable wear basis.~   "
168121|NCT01365026|"~     The potential health gains from healthy lifestyles are very well-known, what is still not~     known is how to help people to adopt these lifestyles, by means of brief interventions~     feasible in routine general practice. This study was designed to explore the feasibility and~     efficacy of innovative implementation strategies for the promotion physical activity, diet~     and smoking abstinence in primary care. The investigators hypothesize that collegiate~     planning between practitioners, researchers and managers, with a socio-ecological perspective~     and taking into account the real context of collaborating centers, will guarantee the~     sustainability and effectiveness of these programs.~   "
168122|NCT01365013|"~     The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN~     Euskadi program for the primary prevention of type-II diabetes in high-risk population seen~     in primary care centers (Osakidetza-Basque Health Service) in which such intervention is~     implemented, compared to usual care control centers.~   "
168123|NCT01365000|"~     The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy~     Subjects.~   "
168124|NCT01364987|"~     This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in~     healthy volunteers.~   "
168125|NCT01364974|"~     The objective of this study is to explore safety and tolerability of multiple oral doses of~     ASP015K in healthy volunteers.~   "
168126|NCT01364961|"~     Although much effort has been done to lower LDL-cholesterol concentrations, there is still a~     substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD~     is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that~     elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite~     many initiatives, no new widely applicable intervention strategies with proven efficacy have~     been developed.~      Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower~     risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert~     a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has~     been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to~     elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human~     intervention studies.~   "
168127|NCT01364948|"~     The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits~     even more vulnerability to the environment due to poor self regulatory heat mechanisms,~     paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight~     as water loss from their skin during the first week of life. Many strategies have been~     utilized by neonatologists to decrease this water loss. Oil application on the skin can act~     as a non permeable barrier and can help in reducing water loss from the skin. Edible coconut~     oil, often used for traditional massage of babies by Indian communities, is culturally~     acceptable and Hence the investigators decided to undertake this study to objectively assess~     the reduction in water loss from skin after oil application~   "
168128|NCT01364935|"~     Comparative study to determine whether several fertility monitoring products - the~     DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are~     substantially equivalent in performance, and secondarily to determine the appropriateness of~     labeling information for the DuoFertility monitor.~   "
168129|NCT01364922|"~     The primary purpose of this study was to evaluate the analgesic effect and safety of~     hydrocodone/acetaminophen extended release compared to placebo.~   "
168130|NCT01364909|"~     This study will investigate whether early exercise in critically ill patients will decrease~     inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.~   "
168142|NCT01364753|"~     Our overall goal has been twofold: 1) to evaluate whether there are significant age-related~     changes in flight simulator performance near age 60, and 2) to assess whether there is an~     alternative model that can explain longitudinal flight simulator performance on the basis of~     measures of cognitive function and expertise.~   "
168143|NCT01364740|"~     Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep~     Apnea.~   "
168144|NCT01364727|"~     A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or~     thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for~     thymic cancers.~   "
168131|NCT01364896|"~     This is an observational cohort study with two time points (baseline and after at least 6~     months of treatment with a non-corticosteroid immunosuppressive agent for inflammatory bowel~     disease (IBD)). Approximately 40 participants, both male and female, 18 years of age and~     older will be recruited from the Pittsburgh IBD Cohort.~      Participants will have a histological diagnosis of IBD (Ulcerative Colitis (UC) or Crohn's~     Disease (CD)) and will be attending for colonoscopy prior to starting a non-corticosteroid~     immunosuppressive agent as part of standard medical care. Immediately following the~     colonoscopy, an anal exam will be performed for research purposes to include:~        1. Perianal inspection~        2. Anal canal HPV swab~        3. Anal cytology~        4. Digital anal examination~        5. High resolution anoscopy (HRA) and biopsy of all lesions with visual criteria consistent~          with high-grade anal dysplasia~        6. For female participants a self- or clinician-taken vaginal swab for HPV typing.~      These procedures will be repeated at routine colonoscopy following at least 6 months but~     within 12 months of non-corticosteroid immunosuppressive treatment.~   "
168132|NCT01364883|"~     This is an open label phase I study, to assess the safety and immunogenicity of novel~     schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP.~     These vaccines have been evaluated previously in a number of clinical trials proved to be~     safe and capable of inducing protective cellular immune response following challenge with the~     parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63~     ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA~     ME-TRAP according to various schedules.. Safety data will be collected for each of the seven~     regimens. Secondary aims of this study will be to assess the immune responses generated by~     each of these regimes.~   "
168133|NCT01364870|"~     Our primary hypothesis is that TENS decreases pain with movement by reducing hyperalgesia.~     Minimizing the severe pain experienced during required activities in the immediate~     postoperative period will promote functional recovery and prevent the development of new~     chronic pain syndromes.~   "
168134|NCT01364857|"~     Port Wine Stain on a limb can be either isolated or associated with complications (venous or~     orthopedic impairment, arteriovenous malformations), leading sometimes to complex syndromes~     (Klippel-Trenaunay syndrome,Parkes-Weber syndrome).~      Little is known about epidemiology of port wine stains: their evolution during the growth of~     the child, the frequency of complications, genetic data, and prognostic factors.~      This prospective french national cohort will help for : description of the evolution of port~     wine stain and possible complications; prognostic factors for complications ; association~     with mutations of RASA1 gene; quality of life of these children. It will also help for global~     appreciation of the management of this disease in France.~   "
168135|NCT01364844|"~     This will be a Phase 1, open-label study of DS-7423 to assess its safety and tolerability,~     identify a RP2D, (recommended Phase 2 Dose) and assess its Pharmacokinetics (PK) (what your~     body does to process the drugs and how your body gets them out of your system.) and~     pharmacodynamics (PDy) (Pharmacodynamics is a study of what a drug does to your body)~     properties in subjects with advanced solid malignant tumors. This study will include 2 parts:~     part 1-Dose Escalation and part 2-Dose Expansion.~      Study Hypothesis: DS-7423 will be safe and tolerable, and will exhibit acceptable PK and PDy~     properties in subjects with advanced solid malignant tumors for whom standard therapy has~     failed or for whom no standard therapy exists.~   "
168136|NCT01364831|"~     In the last few decades much knowledge has been accumulated on the connection between~     healthy, sufficient sleep and overall health, cognitive function, memory and job or school~     performance, motor vehicle accidents and work accidents. There has been growing awareness~     recently of the connection between physical activity and competitive sports performance, and~     the amount and quality of sleep. Despite the dearth of scientific studies, there is a~     constant effort to improve understanding in this field.~      An appropriate procedure designed to evaluate the influence of the quality and amount of~     sleep on ability and athletic performance must fulfill a number of basic requirements:~        1. Isolating the influence of components related to sleep homeostasis and factors relating~          to circadian rhythm.~        2. Neutralizing as much as possible the influence of motivation on the evaluation - one~          must presumably include a significant competitive event (it is not always possible to do~          a simple extrapolation between physiological measurements and competitive performance).~        3. Isolating and canceling as much as possible additional factors affecting performance,~          such as: home advantage, weather, injury and field conditions.~      Athletic activity includes not just competitions but also training towards competitions,~     since it is difficult to control for influences of competitions and other occasional events,~     in this study the investigators focus on evaluation of the connection between sleep and~     athletic performance in training.~      Towards the end of adolescence, youth are busy in multiple activities related to studies,~     social obligations and athletic activity. This is also the age they learn to drive. This is~     an age in which physiologically a person needs more sleep relative to at other ages (9.25~     hours of sleep a day), and paradoxically due to the multiple obligations the amount of sleep~     is lower than needed.~      Beyond the effect on mood, cognitive performance and memory, sleep deprivation causes~     far-reaching changes in multiple systems, such as:~      Cardiovascular System:~        -  Many studies show that shortened sleep duration constitutes an independent cause of~          increased cardiac events.~        -  Resting heart rate and maximum heart rate decrease after 30 hours of sleep deprivation.~      Respiratory System:~        -  Significant decline in respiratory function as measured by: FVC, Maximal voluntary~          ventilation, Maximal static inspiratory/expiratory pressures, Time to exhaustion with~          exercise, Peak O2 consumption, Peak CO2 production.~        -  Worsening of respiratory sleep disturbances.~      Digestive System:~      • Changes in food consumption accompanied by changes in body weight.~      Neurophysiological System~      • Disturbance of thermoregulation.~      Endocrine System:~        -  Hormonal changes associated with hypothalamic-hypophyseal axis~        -  Influence on secretion of Ghrelin and leptin~        -  Influence on secretion of growth hormone.~      In light of this, there is sound basis for the presumption that athletic performance is~     connected to these influences directly and indirectly.~      The purpose of this study is to evaluate the connection between sleep quality and duration~     and athletic performance among young athletes living and training at the Sport-Gifted Centre~     at the Wingate Institute.~   "
168137|NCT01364818|"~     The purpose of the proposed research is to study the potential changes in biomarkers of~     patients with neurodevelopmental disorders in response to treatment in clinical trials or in~     private psychiatry practice utilizing non-invasive psychophysiological measurements. The~     investigators plan to obtain psychophysical measurements throughout several periods of~     treatment.~   "
168138|NCT01364805|"~     In the United States, approximately 30,000 new cases of pancreatic cancer are diagnosed each~     year and an almost equal number of deaths are related to this cancer. Different types of~     chemotherapeutic treatments are used that target different parts of the cancer cell with some~     success, but there is room for other treatment options.~      It is known that people with cancer are using high doses of intravenous vitamin C also known~     as ascorbate, as a cancer treatment and this is occurring frequently. When Vitamin C is given~     in this manner, it is not taken by mouth; instead, it enters your body through an IV~     (intravenous) site, or tube that is inserted through a needle into your vein. If you have a~     port-a-cath in place, the IV will be given using your port. When Vitamin C enters your body~     through an IV site, it is known that it acts like a drug and not a vitamin. It produces a~     substance around the cancer cells called hydrogen peroxide. It has been seen in animal~     research studies that hydrogen peroxide kills the cancer cells while leaving the normal cells~     unharmed.~      Currently the FDA does not approve the use of high-dose intravenous Vitamin C as a cancer~     treatment. The use of intravenous Vitamin C in this study is experimental. Furthermore, it is~     important to know that we do not expect the intravenous Vitamin C given in this study to be~     healing for the treatment of your cancer.~   "
168139|NCT01364792|"~     This is a one-week, randomized, double blind add-on study of valaciclovir versus placebo in~     24 clinical patients with Schizophrenia according to DSM IV, currently experiencing psychosis~     as is defined by the positive items of the Positive and Negative Syndrome Scale (PANNS)~     score, being five or higher on one item or four on two items of this scale. Each patient will~     be randomized to double blind treatment with either valaciclovir or placebo for one week.~      The main objective is to find a pre- and post-valaciclovir treatment difference in~     hippocampal inflammation, as measured with positron emission tomography. The secondary~     objective is to improve cognition by the supposed anti-inflammatory effect on the hippocampus~     of valaciclovir. This is measured by pre- and post-treatment performance on the PANSS, the~     attention and memory test.~      Both the treatment team and the patient will remain blinded during the course of the study.~     Following the active treatment phase, patients will receive treatment as clinically~     indicated.~   "
168140|NCT01364779|"~     The primary objective of the study is to determine the prevalence of aspirin resistance in~     chronic kidney disease patients. The secondary objectives are to determine possible risk~     factors contributing to aspirin resistance in this population.~   "
168141|NCT01364766|"~     The purpose of this study is to find the impact of continuous blood glucose sensors use in~     the classroom/school environment. We will be asking the subject,subject's parent and~     subject's teachers to complete a short survey/questionnaire. The survey will take~     approximately 10-15 minutes.~   "
168145|NCT01364714|"~     Intensive care unit (ICU) admission is associated with muscle weakness and ICU survivors~     report persevering limitation of physical capacity for years after discharge. Limited~     information is available about the underlying biomechanical properties responsible for this~     muscle function impairment.~   "
168146|NCT01364701|"~     Clinical effectiveness is of the finest tools to evaluate treatment success and is combined~     of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the 3~     main PDE5i's differ in their molecular structure, therapeutic profile and pharmacokinetics,~     it seems logical to assume that combining 2 different PDE5i's at lower dosage each may be~     beneficial in comparison to a single PDE5i maximal dose therapy. The aim of this study is to~     compare the clinical effectiveness of combination therapy (2 lower-dose PDE5i's) versus~     single maximal dose PDE5i therapy.~   "
168147|NCT01364688|"~     Active vitamin D at therapeutic dose may prevent vascular calcification but in~     supraphysiologic dose may precipitate it.~   "
168148|NCT01364675|"~     The purpose of this study is to determine whether treating pre-diabetic & pre-hypertensive~     individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus~     anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower~     Cardiovascular Disease (CVD) events.~   "
168149|NCT01364662|"~     This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and~     safety study in children with impulsive aggression comorbid with~     Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and~     female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120~     subjects will be randomized across approximately 30 US centers to one of four treatment~     groups.~   "
168150|NCT01364649|"~     The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily~     (QD), compared with escitalopram on sexual functioning.~   "
168151|NCT01364636|"~     Rationale: Heart Failure (HF) elevated prevalence in Brasil and the world; 20-30% AHF~     patients develop CardioRenal Syndrome (CRS) type 1; Worsening Renal Failure (WRF) is a~     prognostic marker of mortality in Acute HF;NGAL is a novel biomarker of Acute Kidney Injury~     released in 2 hours, and addressed in several different clinical scenarios(contrast injury,~     cardiopulmonary bypass, critical illness.~      Hypothesis: Admission NGAL predicts CRS in AHF patients admitted to the Emergency Room (ER).~      Primary goal: To evaluate the diagnostic accuracy and the best cutoff value of urinary NGAL~     to predict the development of CRS type 1 in patients admitted to the Emergency Room.~      Secondary goals: 1- To evaluate the prognostic impact of NGAL on in-hospital adverse outcomes~     (length of hospitalization, death, institution of renal replacement therapy, use of~     vasoactive drugs, mechanical ventilation).2- Evaluate the prognostic impact of NGAL in~     adverse outcomes in 30 days, 60 days and 6 months (death, rehospitalization, institution of~     renal replacement therapy).3- Identify clinical and hemodynamic characteristics of Acute HF~     that can influence the evolutionary behavior of NGAL levels in 48 hours.4- Identify the~     association of drugs commonly used for HF management, which might influence the evolutionary~     behavior of NGAL levels in 48 hours.5-Assess the impact of NGAL results in clinical decision~     making.~      Methods: Observational, prospective, blinded study. Population: Acute HF patients admitted to~     the ER of Hospital Pró Cardiaco and Hospital Antonio Pedro - Universidade Federal Fluminense.~      Statistics: Convenience Sample size (n=180); determination of best cut-off: ROC analysis;~     Predictive performance of the cut-off: sensibility, specificity, likelihood ratio, predictive~     value, accuracy; Identification of variables to predict CRS: logistic regression and~     square-Qui test; Correlations analysis of normally distributed variables: Pearson's linear~     correlation test; Mean values for normally distributed variables: Mann-Wittney test;~     Significance on p<0,05; Intra-assay variation analysis.~      Study chronogram: Recruitment: 12 months; Results analysis and conclusions: 60 days;~     Manuscript preparation for paper submission: 30 days.~   "
168152|NCT01364623|"~     The purpose of this study is to assess the bioavailability of total testosterone through~     pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2~     b) multiple administration TBS-2.~      In addition, assessing the bioavailability of free testosterone, dihydrotestosterone, SHBG~     and estradiol through pharmacokinetic profiles will also be conducted.~   "
168153|NCT01364610|"~     Gastroesophageal reflux disease (GERD) is a common and potentially debilitating disorder.~     Typical symptoms include heartburn and regurgitation of acid tasting substances. GERD is a~     chronic disease and in some cases, more alarming symptoms including food sticking in the~     esophagus, pain with swallowing, bleeding, anemia and weight loss develop.~      In Alberta, upper endoscopy is the first line of investigation accompanied by an ambulatory~     24-hour esophageal pH monitoring for patients with symptoms that are unresponsive to~     acid-suppressing therapy or who exhibit alarm symptoms.~      Current standard of care in Alberta for esophageal pH monitoring first requires an esophageal~     manometry test to identify the location of the lower esophageal sphincter followed by the~     placement of a thin catheter with one or more pH probes inserted through the nose and taped~     in place to the face for 20 -24 hours. The patient wears a small battery powered data logger~     and maintains a diary of GERD symptoms and activity. This system enables the recording and~     correlation of specific symptoms with reflux episodes over extended periods and provides~     direct evidence of GERD. The nasally passed pH catheter is uncomfortable and restrictive for~     some patients often resulting in abnormal eating, drinking, activity and sleeping patterns.~     The data collected may not be representative of the patient's typical experience and may not~     reflect the true severity of the disease.~      A wireless diagnostic pH monitoring system called Bravo pH Monitoring System developed by~     Medtronic is approved for use in Canada and is commercially available. This system eliminates~     the need for a catheter by utilizing a capsule the size of a gel-cap and radio frequency~     technology to monitor esophageal pH. It has been shown to be safe and as sensitive as~     conventional catheter-based pH probe monitoring. The Bravo system can be sited either~     endoscopically or manometrically.~      The goal of this study is to test the Bravo Wireless pH system in Alberta using manometric~     siting to assess feasibility, patient outcomes and tolerance.~      Hypotheses:~        1. Patient tolerance of the Bravo system is superior to standard pH-metry.~        2. Manometric placement of Bravo is as successful as standard pH-metry.~      Our aims:~        1. To assess patient tolerance of Bravo versus standard pH-metry.~        2. To compare the success rate of manometric peroral placement of Bravo pH probe versus~          standard pH-metry.~   "
168154|NCT01364597|"~     This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects~     with epilepsy.~   "
168155|NCT01364584|"~     Previous research in our lab and others has established that type 2 diabetes (T2D) is~     associated with significantly impaired functional exercise capacity, a factor which is~     potentially associated with an increased risk of cardiovascular disease in those with type 2~     diabetes. Of great concern, the majority of people with type 2 diabetes are sedentary and one~     possible reason may be that exercise, even at low levels, is perceived as being a harder~     effort than for nondiabetic people. Thus, treatments that may motivate patients with type 2~     diabetes to be more physically active have great potential benefit.~      Recent observational studies suggest that glucagon-like peptide-1 agents, such as exenatide,~     may have a beneficial effect on endothelial and cardiac function. Because these two factors~     have been shown to be associated with exercise dysfunction in type 2 diabetes, the~     investigators hypothesize that exenatide may improve exercise capacity in those with type 2~     diabetes. The aims of this study are to (1) assess whether exenatide will improve functional~     exercise capacity in persons with type 2 diabetes and (2) investigate the effect of exenatide~     on specific metabolic, endothelial, cardiac and peripheral circulatory measures of function~     related to changes in exercise capacity. The Investigators primary hypothesis is that~     exenatide will improve functional exercise capacity in people with type 2 diabetes. Having a~     drug that improves exercise capacity could motivate patients to exercise more and hence be a~     significant benefit.~   "
168156|NCT01364571|"~     This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of~     three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The~     main goal of the study is to determine how safe and well tolerated the vaccine is as well as~     to describe the immune response elicited by the vaccine in healthy adults aged 18 to <65~     years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence~     of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy~     adults aged 18 to <65 years.~   "
168157|NCT01364558|"~     The purpose of this clinical research study is to assess the bioavailability and~     pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and~     injectable diazepam after intravenous (I.V.) administration~   "
168158|NCT01364545|"~     Parkinson's disease is a progressive condition that harms nerve cells of the brain~     (neurodegeneration). Current treatments for Parkinson's disease (including levodopa and deep~     brain stimulation) improve certain symptoms but are not thought to improve the underlying~     neurodegenerative disease process (they are not a cure). The cause of Parkinson's disease~     is unknown. However, some evidence suggests that tiny structures in the investigators cells~     called mitochondria might be involved. Mitochondria are the powerhouses that produce fuel~     for the investigators cells. Failure of these 'powerhouses' to supply the energy needs of~     certain nerve cells might lead to Parkinson's disease. Preliminary evidence suggests that a~     food called 'ketones' might be able to enhance the function of mitochondria and improve~     Parkinson's disease symptoms and possibly even the neurodegenerative process. In this study,~     the investigators would like to investigate this possibility by giving patients with~     Parkinson's disease dietary supplements of 'ketone esters' in a drink. The investigators will~     then assess if this improves symptoms of Parkinson's disease.~      The study design is a prospective, double blinded, randomised, controlled trial.~   "
168159|NCT01364532|"~     The transradial route is increasingly used as an access site in percutaneous coronary~     interventions, as it is considered equivalent to transfemoral approach in terms of efficacy~     but with a decreased vascular complication risk. Information concerning the efficacy and~     safety of transulnar approach is sparse. This is a prospective, randomized,~     investigator-initiated study to compare transradial versus transulnar approach as a default~     strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention~     (PCI). Consecutive eligible patients with an indication for coronary angiography, will be~     randomized after written informed consent in a 1:1 ratio to either transradial or transulnar~     access. Assessment of angiographic and procedural characteristics(including amount of~     contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular~     or other peri-procedural complications of the cases enrolled, will be performed. After~     hospital discharge, all patients will return at Day 60 ±5 days for Doppler ultrasound~     assessment of the forearm vessels and documentation of major adverse cardiovascular events~     (defined as death, myocardial infarction, target vessel revascularization and stroke.~     Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500~     or 5000 IU of unfractioned heparin.~   "
168160|NCT01364519|"~     Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled~     lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment~     of inflammation will be via sputum induction.~   "
168161|NCT01364506|"~     Objective: To assess the relationship between maternal cardiovascular capacity and aerobic~     water exercise during the gestational periods of hemodynamic overload. Study design:~     randomized clinical trial, with 41 healthy pregnant women assigned to one of two groups:~     Control and Water exercise. Maternal cardiovascular capacity (maximum oxygen consumption,~     cardiac output, stroke volume, heart rate and mean arterial pressure), physical performance~     (relative HR, treadmill speed and self-perceived exertion) and neonatal outcome (gestational~     age, weight, Apgar index and length of infant's hospitalization) were assessed. Means were~     evaluated by dependent and independent t-tests, and proportions by the chi-square method~     (p<0.05). Results: The control variables showed that the groups were homogeneous. Water~     exercise was associated with maintenance of VO2max, increase in stroke volume and cardiac~     output, and better performance on stress tests in the third trimester of gestation. No~     significant difference in neonatal variables was observed. Conclusion: Water exercise~     maintained cardiovascular capacity and performance under submaximal stress, and did not~     affect hemodynamic adaptation to gestation or neonatal outcome.~   "
168162|NCT01364493|"~     Although the overall incidence of gastric cancer has steadily declined in many Western~     countries during the last few decades, it is still one of the most common tumors in China. It~     is now well recognised that combination chemotherapy regimens improve patient outcomes, but~     there is no accepted global standard regimen for advanced gastric cancer.~      The ToGA study was the first randomized, prospective, multicenter, phase III trial to show~     the efficacy and safety of Trastuzumab in HER2- positive GC. Trastuzumab reduced the risk of~     death by 26% (HR 0.74; 95% CI 0∙60, 0∙91; p=0∙0046) when combined with a reference~     chemotherapy (Capecitabine plus Cisplatin) and prolonged the median survival by nearly 3~     months (from 11.1 to 13.8 months) in patients with HER2-positive(FISH+ or IHC3+) advanced GC.~      Oxaliplatin has been shown to be as effective as cisplatin, and exhibits a favorable toxicity~     profile with a substantially lower rate of nephrotoxicity, ototoxicity, and myelosuppression.~      In the current study, the efficacy and safety of Trastuzumab in combination with~     Oxaliplatin/capecitabine chemotherapy will be evaluated in Chinese patients with HER2~     positive advanced or recurrent gastric cancer.~   "
168163|NCT01364480|"~     The purpose of this research study is to demonstrate the safety and efficacy of using two~     NeuroPort Arrays (electrodes) for long-term recording of brain activity.~   "
168164|NCT01364467|"~     This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of~     oral guaifenesin for the therapy of Chronic Rhinitis in 36 children between the ages of 7 and~     18 years. The study investigates the effectiveness of guaifenesin in the relief of nasal~     symptoms in children with CRS using the sinonasal 5 survey (SN-5) in comparison to nasal~     airway volume, and biophysical properties of nasal secretion. The investigators hypothesize~     that Guaifenesin use over a period of 14 days improves subjective nasal complaints in~     pediatric patients with chronic rhinitis and nasal congestion, as measured by the SN-5 survey~     compared to use of placebo. There will be an observed improvement in nasal volume and~     cross-sectional area following use of guaifenesin, and nasal secretions will have more~     favorable mucociliary and sneeze clearability compared to use of placebo.~   "
168165|NCT01364454|"~     Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence~     that it reduces mortality from CRC and that it's cost-effective. In France, there is a~     national CRC screening programme inviting people aged 50-74 years by mail to consult their~     General Practitioner (GP) for a free on charge Faecal Occult Blood test deliverance every two~     years. Participation is a key factor for the screening programs success. High levels of~     screening uptake and the continued participation to regular screening must be achieved and~     maintained in the targeted population if the enormous potential of CRC screening is to be~     realised. Screening rates of various international programs vary widely (20-52%) and the~     participation is insufficient in the most settings. Therefore, a better understanding of~     facilitating and hindering factors of patient participation can guide interventions to~     improve CRC screening rates. They include patients and physicians' factors. One issue is~     about GPs practice. GP involvement has been shown to improve the participation in the CRC~     screening. This study aims to assess the effectiveness of an intervention targeting GPs to~     increase patient participation in the CRC screening. Volunteer GPs will be randomly assigned~     to either the intervention group or to usual care (control group) and they will be followed~     one year. The intervention consists in providing every four months to the experimental group~     a list of their patients who are eligible but did not proceed yet to the screening. In both~     groups, patient participation in the screening will be measured at the end of the study.~   "
168166|NCT01364441|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-2952~     across ascending single doses in healthy adult male and female subjects. The secondary~     objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary~     objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile~     of ONO-2952.~   "
168167|NCT01364428|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in~     subjects with type 2 diabetes.~   "
168168|NCT01364415|"~     This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced~     Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics~     and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.~   "
168169|NCT01364402|"~     This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule~     for primary PCI or elective PCI will randomly allocated to receive either a single dose of~     EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.~      The investigators assume that the incidence rate of CIN will be significantly lower in the~     EPO group compared to placebo. In addition, EPO administration will result in a decrease of~     infarct size.~   "
168170|NCT01364389|"~     The study is a two-week, single-blinded, double-dummy, randomized, active-controlled,~     parallel group design, with a follow-up period up to a total study duration of 6-month,~     non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare.~     It is a multicentric, multinational study. The protocol will seek to enroll a total of 30~     patients, who will be randomized to the 3 arms at a ratio of 1:1:1.~      Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing~     period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after~     their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the~     case of a disease flare.~   "
168171|NCT01364376|"~     This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus~     5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative~     chemotherapy for advanced gastric cancer.~      Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric~     cancer.~   "
168172|NCT01364363|"~     The purpose of this study is to provide an opportunity for patients with malignancies or bone~     marrow failure states who lack a suitable sibling donor to undergo allogeneic hematopoietic~     progenitor cell transplantation using cells from unrelated individuals or cord blood~     registries.~   "
168173|NCT01364350|"~     The purpose of this study is to continue to follow participants in the TODAY clinical trial~     as they transition to non-blinded, non-randomized standard diabetes care and management with~     monitoring and follow-up for up to 24 months (phase 1), during which time the TODAY data are~     analyzed and findings interpreted to develop a long-term observational protocol (phase 2).~     Data are collected during phase 1 for descriptive purposes; there is no primary hypothesis.~   "
168174|NCT01364337|"~     Prevalence rates of hypertension and diabetes are high in Taiwan. Little attention is given~     to evidence-based dietary therapy in Taiwan. Patients, after confirmed diagnosis, are mostly~     prescribed with medications without comprehensive instructions on dietary therapy. DASH diet~     has been proven to be an effective dietary approach to reduce blood pressure for hypertension~     patients in US. However, dietary difference and patient profiles across countries are~     evident. In addition, hypertensive patients are often combined with hyperglycemia.~     Carbohydrate burden of DASH diet may be higher than most dietitians desire. Therefore, the~     investigators in tend to design a Taiwanese DASH diet and a lower carbohydrate DASH diet and~     test their efficacy on both blood pressure and fasting glucose lowering.~   "
168175|NCT01364324|"~     The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile~     of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).~   "
168186|NCT01364181|"~     Pulmonary hypertension (PH) is a serious complication of COPD which is associated with~     shorter survival, more frequent exacerbation, and increased use of health resources. There is~     no effective pharmacological treatment for COPD-associated PH. Therefore, the investigators~     wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (PDE-5) inhibitor, on~     exercise capacity of severe COPD patients.~   "
168187|NCT01364168|"~     The primary aim of the study is to derive and validate risk scores for vascular endpoints~     (recurrent stroke, myocardial infarction, and other complications of stroke) and for death~     following an incident stroke. For this purpose patients with an incident stroke will be~     followed for 36 months with additional assessments at 3, 12, 24 and 36 months.~   "
168188|NCT01364155|"~     Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral effects~     on weight in obese and diabetic rodent models. Results from a Phase 1b clinical study,~     conducted in healthy volunteers, indicate that LIM-0705 and a major metabolite may be~     potential insulin sensitizers by OGTT.~   "
168176|NCT01364311|"~     Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory~     response on the ocular surface. Common symptoms include ocular discomfort, visual impairment~     and instability of the tear film with potential damage to the ocular surface.~      In addition, an intact tear film is important to provide a smooth optical surface, to act as~     a barrier to pathogens, to nourish the epithelial cells of the ocular surface and to prevent~     exsiccation. Alterations in the tear film composition, which can have their origin in several~     conditions, lead to tear film hyperosmolarity or instability resulting in DES.~      Regardless of the cause of DES, chronic dryness of the ocular surface leads to an increased~     susceptibility to oxidative stress, which is triggered by reactive oxygen species (ROS). This~     results in cell damage and activation of the immune system, keeping up inflammatory processes~     . In order to prevent ROS damage, several micronutrients such as vitamin C, E, and certain~     carotenoids, omega-3 free fatty acids, flavonoids and minerals have been used because of~     their antioxidant capacities.~      Based on this knowledge the potential of these antioxidant dietary supplements has been~     discussed as a treatment option for DES. Preliminary data support the hypothesis that~     antioxidant supplementations, in particular, supplementation with omega 3 fatty acids may be~     beneficial for patients with DES.~      The purpose of the present study is to test the hypothesis that treatment with dietary~     supplements improves subjective and objective symptoms of DES.~   "
168177|NCT01364298|"~     This is a multicenter, randomized, open-label, parallel, Phase 4 clinical trial to compare~     efficacy and safety of gabapentin/B-complex versus pregabalin in diabetic peripheral~     neuropathy pain (DPNP) management.~   "
168178|NCT01364285|"~     The investigators know little about how patients feel following radiosurgery treatment of~     trigeminal neuralgia. Patient satisfaction may ultimately be one of the most important~     outcome measures for an individual patient; however, this has not been adequately assessed or~     followed. Multiple questions remain unanswered, including whether there is a correlation~     between patient satisfaction, the level of their current pain score, and the presence and~     degree of facial numbness, a possible side effect after radiosurgery. Therefore, the goal of~     this study is to gather this information from the patients who received radiosurgery for~     trigeminal neuralgia at Stanford and evaluate post-treatment patient satisfaction, the degree~     of facial numbness, and current pain score. This data will help the investigators understand~     outcomes that are important for patient satisfaction following treatment of a chronic pain~     syndrome.~   "
168179|NCT01364272|"~     Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that~     significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has~     been shown to provide pain relief in majority of patients treated. However, a common side~     effect of radiosurgery is facial numbness. To better understand how radiosurgery can bring~     about pain relief and facial numbness, we are conducting a study in which brain MRI scans~     will be done following stereotactic radiosurgery to learn if there are any changes in the MRI~     scans that correlate with symptoms.~   "
168180|NCT01364259|"~     Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that~     significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has~     been shown to provide pain relief in majority of patients treated. However, a common side~     effect of radiosurgery is facial numbness. Our goal is to maximize pain control while~     minimizing side effects. To this end, the purpose of this study is to evaluate whether adding~     a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.~   "
168181|NCT01364246|"~     Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune~     demyelinating disease of the central nervous system, along with a considerable pathological~     heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease,~     and its clinical characteristics include recurrent optic neuritis and longitudinally~     extensive transverse myelitis.~      Current therapies provide only modest control of progressive Multiple Sclerosis and~     Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an~     efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of~     Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients~     with progressive MS and NMO.~   "
168182|NCT01364233|"~     Surgically repair of large abdominal hernias requires prosthetic materials such as mesh-like~     products. A relatively new synthetic product cPTFE is designed as a cost effective~     alternative to reduce associated post surgical complications. The study will monitor patients~     over a one year period.~   "
168183|NCT01364220|"~     It is anticipated that 548 subjects will be recruited from approximately 27 centres in South~     Korea.~      This is an investigator-sponsored, double-blind, placebo-controlled, randomized, multi-centre~     study to assess the effects of rosuvastatin 20 mg compared to placebo in acute ischemic~     stroke patients, with the first dose within 18 hours after baseline MRI and continued~     treatment for 14 days.~      Subjects will be male or female, over 20 years, with diagnosis of acute ischemic stroke with~     baseline MRI, and who are either statin-naïve or untreated with statin for the previous 3~     months.~      The objective would be to compare the recurrence rate of ischemic stroke by comparing the~     imaging parameters during 14 days of treatment and clinical improvement as defined by percent~     improvement based on NIHSS scores measurements at baseline, 5 days and 14 days of treatment.~   "
168184|NCT01364207|"~     High intraocular pressure (IOP) is a known risk factor for developing primary open-angle~     glaucoma (POAG). There is controversy in the literature regarding the degree to which~     caffeine influences IOP, with some studies reporting minimal changes in IOP while others~     report up to 4 mmHg increases. To date there are no double-masked randomized controlled~     trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk for~     primary open-angle glaucoma. The investigators aim to better understand the relationship~     between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a~     double-masked, crossover randomized controlled clinical trial.~   "
168185|NCT01364194|"~     The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25%~     bupivacaine for controlling pain after total knee replacement to improve the quality of~     post-operative care.~   "
168189|NCT01364142|"~     One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji~     Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice.~     We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic~     bronchoscopy.~   "
168190|NCT01364129|"~     This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect~     diabetic retinopathy when compared to traditional surveillance methods, 2) identify the~     health belief factors related to adherence with annual diabetic eye exams, and 3) determine~     the cost-effectiveness of the telemedicine system from the perspective of the community~     clinic, the third-party payer, and the individual patient.~   "
168191|NCT01364116|"~     Measuring total hemoglobin(tHb) is a precious step to decide to start or to stop transfusion~     during operation. The newly developed instrument pulse CO-Cooximetry (Masimo) makes~     noninvasive monitoring of venous hemoglobin level (SpHb).~      The objective of this study~        -  to compare the simultaneous level of tHb and SpHb during operation and after volume~          expansion in children~        -  to assess the accuracy of amount of acute change of SpHb on Masimo and tHb~   "
168192|NCT01364103|"~     The purpose of this study is to evaluate static and dynamic parameters, echocardiographic~     parameters, and pleth variability index for predicting fluid responsiveness in children.~     Children who need volume expansion will receive colloid 10 mL/kg. Blood pressure, heart rate,~     central venous pressure, systolic pressure variation, pulse pressure variation, delta down,~     aortic blood flow velocity variation, inferior vena cava diameter variation, and pleth~     variability index will be measure before and after volume expansion. Patients will be~     classified as responders to volume loading if stoke volume index increase by at least 15%.~   "
168193|NCT01364090|"~     This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and~     effective for patients who are current injection drug users or receiving opiate substitution~     therapy and who are responding well to treatment early on.~   "
168194|NCT01364077|"~     A significant association between resting heart rate (HR) and both all-cause mortality and~     cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the~     general population and for patients with cardiovascular disease.~      Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study~     reported that the 48-hr mean HR is an independent predictor of cardiovascular events in~     normotensive hemodialysis patients.~      Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial~     antianginal effects and mortality reduction linked to HR reduction in ischemic patients.~      Aim:~      To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with~     increased pre-dialysis HR (> 80 bpm)~   "
168195|NCT01364064|"~     This is a Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose Intensive~     Temozolomide in Patients with Newly Diagnosed Glioblastoma.~   "
168196|NCT01364051|"~     This phase I trial studies the side effects and best dose of cediranib maleate and~     selumetinib in treating patients with solid malignancies. Cediranib maleate and selumetinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Cediranib maleate may also stop the growth of tumor cells by blocking blood flow to the~     tumor.~   "
168197|NCT01364025|"~     Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of~     hysterectomy?~      The answers to these questions will facilitate the treatment of many American women. With the~     results of this study, the investigators would anticipate a reduction in the number of~     surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was~     shown to be ineffective, it would not be used routinely in the setting of hysterectomy and~     women will be spared the additional procedure and possibility of side effects or~     complications.~      The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at~     the time of hysterectomy in women without symptomatic prolapse symptoms have never been~     studied prospectively.~   "
168198|NCT01364012|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety~     of bevacizumab (Avastin) versus placebo in combination with carboplatin/paclitaxel in~     participants with advanced or recurrent non-squamous non-small cell lung cancer who have not~     received prior chemotherapy for advanced disease. Participants will be randomized to receive~     either bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) or placebo on Day 1~     of each 3 week cycle, plus up to 6 cycles of carboplatin/paclitaxel. Anticipated time on~     study treatment is until disease progression or unacceptable toxicity occurs. After~     progression, participants in the bevacizumab arm may continue to receive bevacizumab in~     combination with approved second- and third-line treatment at the discretion of the~     investigator, up to the third progression.~   "
168199|NCT01363999|"~     A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and~     atorvastatin from prototype fixed dose combination formulations in healthy volunteers.~     Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four~     treatment periods.~   "
168200|NCT01363986|"~     This single-arm, multicenter, open-label study will evaluate the efficacy and safety of~     Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in~     patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg~     (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on~     study treatment is 18 weeks.~   "
168201|NCT01363973|"~     Oropharyngeal dysphagia (OD, swallowing dysfunction) is a major complaint following stroke.~     Despite its enormous impact on functional capacity, quality of life, and survival, OD is both~     underestimated and underdiagnosed as a cause of major nutritional and respiratory~     complications in stroke patients. A recent systematic review on the effects of rehabilitation~     therapy on OD concluded that although some positive effects were found, the number of studies~     was small, many of them had methodological problems and there was a need for further research~     using randomized controlled trials. Transcutaneous electrical stimulation was approved by the~     FDA as a treatment of dysphagia in June 2001 and is traditionally used to activate pharyngeal~     muscles through stimulation of peripheral motor nerves (neuromuscular electrical~     estimulation, NMES). However, their real effectiveness and safety in the treatment of~     dysphagia is still matter of discussion (Logemann Dysphagia 2007, Ludlow dysphagia 2007) and~     studies evaluating NMES therapy, present discordant results. On the other hand, in recent~     years, transcutaneous electrical stimulation is beginning to use as a sensory strategy~     (Gallas 2010), avoiding muscle contraction during the treatment.Our research strategy~     includes the assessment of the therapeutic effect of these two main strategies using~     transcutaneous electrical stimulation on swallow physiology and clinical outcomes of~     post-stroke dysphagic patients.~   "
168202|NCT01363960|"~     The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity~     screening.~   "
168203|NCT01363947|"~     Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A~     administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to~     participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The~     study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.~   "
168204|NCT01363934|"~     This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active~     controlled, Dose-escalation Study to investigate the safety, tolerability, and~     Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous~     Administration in Healthy Male Subjects.~   "
168205|NCT01363921|"~     The purpose of this study is to determine whether high porous membranes are effective in the~     treatment of cardiovascular events in chronic dialysis patients.~   "
168206|NCT01363908|"~     This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability~     of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single~     16 mg/kg dose of SSP-004184AQ; and the chronic dosing phase, during which patients will~     receive an additional 48 weeks of SSP-004184AQ dosing. Two age groups will be studied: 6-<12,~     and 12-<18 years old. The study is designed to initially assess the pharmacokinetics and~     safety of SSP-004184AQ in older children (adolescents, 12-<18 years old) and then if deemed~     safe, in younger children (6-<12 years old).~   "
168207|NCT01363895|"~     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, associated with an~     increased risk of morbidity and mortality1. The management of AF patients is aimed at~     reducing symptoms and at preventing severe complications associated with AF. In the last~     years, two new strategies have emerged with different objectives. In the PROTECT AF study2,~     percutaneous closure of the Left Atrial Appendage (LAA) with a closure device provided an~     alternative strategy to oral anticoagulation for stroke prophylaxis. The AFFIRM trial3 has~     shown that drug-based management of AF with a rhythm-control strategy conferred no advantage~     over a rate-control strategy in cardiovascular mortality and might be associated with an~     increased noncardiovascular death rate4. Catheter ablation has gained a greater place in the~     rhythm control strategy, showing superiority in maintaining sinus rhythm in comparison with~     AAD5. However, in persistent AF, repeat ablation procedures are necessary in up to 70% of~     patients to achieve sinus rhythm at a long-term follow-up6-7.~      This prospective, randomized trial will compare the percutaneous closure of the LAA combined~     with a rate-control strategy to catheter ablation in the management of patients with~     persistent AF. Patients who are eligible for catheter ablation as well as LAA closure device~     implantation and are willing to participate in the study will be randomly assigned to~     catheter ablation or percutaneous closure of the LAA by a closure device implantation in the~     relation 1:1. The primary endpoint of the study is a composite endpoint at 12 months of all~     cause death, thrombo-embolic events, major bleeding (BARC type 3), re-hospitalisation and~     severe symptoms due to arrhythmias. Secondary endpoints include a composite endpoint of~     bleeding, a composite endpoint of thrombo-embolic events, cardio-vascular mortality, total~     duration of hospitalisation, sustained discontinued anticoagulation, quality of life~     improvement, use of Antiarrhythmic Drugs (AAD), total costs, freedom from arrhythmia and~     average ventricular frequency in 7-day holter ECG at 12 months.~      The objective of the study is to assess the superiority of percutaneous closure of the LAA~     combined with rate-control to catheter ablation in patients with oligosymptomatic AF.~   "
168208|NCT01363882|"~     Use of noninvasive ventilation (NIV, also known colloquially as Bipap) has been associated~     in some studies with improvement in pulmonary function, quality of life and survival. NIV is~     typically applied during sleep, and without the benefit of sleep study to determine the~     optimal settings. The investigators have shown that when NIV is used in this fashion, failure~     of nocturnal oxygenation and ventilation is prominent. This study is randomizing patients to~     standard application of NIV vs application guided by use of sleep study data to determine the~     effect of titrated therapy on pulmonary function, quality of life and survival.~   "
168209|NCT01363869|"~     Green tea has been extensively investigated for several potential health benefits. Previous~     studies have suggested that green tea may lower serum uric acid level in human. The purpose~     of this study is to investigate uric-lowering properties of green tea in healthy individuals.~   "
168210|NCT01363856|"~     The primary aim of the study is to derive and validate risk scores for vascular endpoints~     (recurrent stroke, myocardial infarction, and other complications of stroke) and for death~     following an incident stroke. For this purpose patients with an incident stroke will be~     followed for 36 months with additional assessments at 12, 24 and 36 months.~   "
168211|NCT01363843|"~     The purpose of this study is to find out how well patients with cancer of the rectum do if~     they get all of their other treatment - chemotherapy by itself followed by chemotherapy and~     radiation together - before surgery. Patients have recently been diagnosed with rectal~     cancer, and the doctors have recommended neo-adjuvant chemo treatment to try to shrink the~     cancer before removing it.~   "
168212|NCT01363830|"~     Post-operative restrictions following lumbar discectomy is a controversial topic. While the~     most widely accepted protocol restricts bending, lifting, and twisting for four to six weeks~     following discectomy, a number of studies support an early return to full activity without~     restriction. Since the goal of discectomy is to promptly provide pain relief and a return to~     a fully active lifestyle, perhaps post-operative restrictions are more hindering than~     beneficial.~      Hypothesis: Post-operative restrictions following lumbar discectomy do not influence~     reherniation rate.~      Specific Aim 1: To compare the reherniation rates between the 6-weeks of restriction and the~     2-weeks of restriction groups.~      Specific Aim 2: To determine the return to full activity and return to work dates of both the~     6-weeks of restriction and 2-weeks of restriction groups.~      Specific Aim 3: To assess the health outcomes of both the 6-weeks of restriction and 2-weeks~     of restriction groups.~   "
168213|NCT01363817|"~     The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either~     alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic~     leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from~     standard therapies~   "
168214|NCT01363804|"~     This study is designed to evaluate the effect of rifampin on the Pharmacokinetic (PK) profile~     of tivozanib.~   "
168228|NCT01363622|"~     The aim of this study was to investigate circulating concentrations of vaspin in fetal and~     neonatal samples from SGA, AGA and LGA with the respective insulin concentrations. Serum~     vaspin concentrations were determined by enzyme immunoassay in 22 SGA and 30 LGA and 30 AGA~     singleton full-term fetuses and neonates on cord blood and postnatal day 5.~   "
168229|NCT01363609|"~     The aim of this study is to investigate if endogenous Glucagon Like Peptide -1 (GLP-1) has an~     effect on brain satiety and reward systems and if there are alterations in obese patients~     with type 2 diabetes (T2DM). Secondly, the aim is to investigate whether treatment with a~     GLP-1 analog, liraglutide, restores these signals in obese patients with type 2 diabetes.~     Finally, also the endogenous GLP-1 effects will be investigated in obese individuals before~     and after gastric bypass surgery on brain satiety and reward systems.~   "
168215|NCT01363791|"~     Diabetes and heart associations continue to discourage high intakes of dietary fructose, a~     constituent part of the sucrose molecule that is found in fruits and vegetables as a natural~     sugar and in some processed foods and beverages as an added sweetener. The concern relates to~     its ability to increase certain blood fats and cholesterol, which increase the risk of~     cardiovascular disease. The evidence for an adverse effect of fructose on these risk factors,~     however, is inconclusive. To improve the evidence on which nutrition recommendations for~     fructose are based, the investigators therefore propose to study the effect of fructose on~     blood fats, cholesterol, sugars, blood pressure, and body weight, by undertaking a systematic~     synthesis of the data taken from all available clinical studies in humans. This technique has~     the strength of allowing all of the available data to be pooled together and differences to~     be explored in groups of different study participants (healthy humans of different sex,~     weight, and age and in those with diseases which predispose to disturbances in metabolism,~     such as diabetes) with dietary fructose in different forms, doses, and with differing~     durations of exposure. The findings generated by this proposed knowledge synthesis will help~     improve the health of consumers through informing recommendations for the general public, as~     well as those at risk of diabetes and cardiovascular disease.~   "
168216|NCT01363778|"~     This study is designed to evaluate the effect ketoconazole on the Pharmacokinetic profile of~     tivozanib.~   "
168217|NCT01363765|"~     Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and~     inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of~     sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4~     to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique,~     named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in~     addition to identification of cases resistant to certain drugs used to treat TB. The test is~     expensive, but several studies have demonstrated its accuracy, and since most steps are~     automatized, savings can be expected from human resources work. The aims of our study are (1)~     to evaluate this tool as a substitute test for sputum smears in routine conditions; (2)~     evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the~     extra cost, and (3) evaluate the acceptability of the test among patients and health care~     workers.~   "
168218|NCT01363752|"~     The purpose of this study is to compare the effect of two anti-rejection therapy regimens on~     kidney function in kidney transplant recipients.~   "
168219|NCT01363739|"~     -1498C/T VEGF polymorphism, as suggested by a recent retrospective analysis, seems to have a~     role in predicting the efficacy of Bevacizumab plus FOLFIRI in first-line treatment of~     metastatic colorectal cancer patients. The present study aims to prospectively evaluate the~     predictive role of this polymorphism in metastatic colorectal patients receiving the same~     treatment.~   "
168220|NCT01363726|"~     The purpose of this study is to monitor diarrheal disease and observe changes after the~     introduction of the rota vaccine.~   "
168221|NCT01363713|"~     Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic~     conjunctivitis, in an open-label, multicenter study.~   "
168222|NCT01363700|"~     The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution~     compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients~     with allergic conjunctivitis.~   "
168223|NCT01363687|"~     The purpose of this study is to investigate whether upper limb ischemic postconditioning can~     improve renal function and decrease ischemic-reperfusion injury in patients undergoing living~     donor kidney transplantation.~   "
168224|NCT01363674|"~     This is a National, Multicentre, Observational Registry to study adherence and long term~     outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth~     hormone treatment from hospitals in Greece and to assess the level of adherence of subjects~     receiving SAIZEN® via Easypod™.~   "
168225|NCT01363661|"~     Molsidomine used as an add-on treatment on standard care therapy should be superior to~     placebo used also as an add-on treatment on standard care therapy on improving the~     endothelial function (endothelium score measured by reactive hyperemia - peripheral arterial~     tonometry [RH-PAT]) after 12 months of treatment in patients with stable angina patients and~     undergoing elective percutaneous coronary intervention.~      The study will be double-blind, parallel-group, randomised, multicentre, sequential,~     placebo-controlled study.~      The device used to determine RH-PAT will be EndoPAT. Duration of the treatment = one year.~   "
168226|NCT01363648|"~     To date, there are no approved treatments for vascular cognitive impairment (VCI) and the~     main therapeutic efforts are aimed at controlling vascular risk factors for countering VCI~     development or progression. Several studies have reported cholinergic deficits in brain and~     cerebrospinal fluid of patients with VCI. The effect of choline alphoscerate in clinical~     studies of Alzheimer's disease and VCI improved memory and attention impairments. The purpose~     of our study is to determine effectiveness of choline alphoscerate vs placebo in improving~     cognition in post-stroke patients with VCI-non dementia (VCI-ND).~   "
168227|NCT01363635|"~     Severe sepsis/septic shock are serious complications of infection with high morbidity and~     mortality. Recent information showed that early and aggressive resuscitation with goal~     directed therapy help improving survival and outcome especially the resuscitation within the~     first 6 hours. In surgical patients, either severe sepsis/septic shock bought them to the~     operating room or this sepsis might be found after surgery resulting in higher morbidity and~     mortality. Not only knowledge management, others possible risk factors should also be~     identified and corrected for outcome improving. This prospective observational study will be~     done in 800 adult surgical patients admitting to the general surgical intensive care unit.~     Incidence of severe sepsis/septic shock on admission along with risk factors associated with~     poor outcomes [organ failure (AKI, ALI, PMI, liver failure, stroke), prolonged ICU length of,~     stay, ICU death] will be recorded especially effect of amount and type of fluid replacement~     in the first 6 hours, 24, 48 and 72 hours after diagnosis. Knowledge about severe~     sepsis/septic shock was implemented among the associated personal, outcome as major organ~     failure, ICU length of stay, ICU death will also be compare between this prospective study~     and historical controlled.~   "
169461|NCT01347463|"~     Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle~     advancement during Internal Jugular Vein (IJV) catheterization has weak grounds.~      The investigators attempt to validate this long-standing statement.~   "
168230|NCT01363596|"~     NaProTechnology (NPT) is a treatment option for infertility or miscarriage that identifies~     issues in a couple's fertility and fixes them to the extent possible by medical intervention.~     An important part of NPT is teaching couples to monitor the signs and symptoms of the woman's~     fertility cycle (menstrual cycle) with the Creighton Model FertilityCare System (CrMS).~      The purpose of the study is to look at outcomes among couples who consider or get NPT~     treatment to help them have a live birth. Results from the study will be used to answer~     questions such as:~      How many couples who use NPT get pregnant and have a baby? How can NPT treatment be improved?~     Does NPT treatment have fewer long-term health risks for the resulting children than other~     fertility treatments? What types of characteristics or environmental exposures influence~     whether NPT will be successful for a specific couple?~      To be eligible for the iNEST study, a couple must have a consultation with a NPT-trained~     clinician who is participating in iNEST.~   "
168231|NCT01363583|"~     This study is a prospective consecutive double-blinded randomized study on the effect of~     PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe~     traumatic brain injury. All patients with severe traumatic brain injury were eligible for~     inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at~     intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion pressure~     (CPP) of > 10 mm Hg, and arrival within 24 hours after trauma.~      Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a~     lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment.~      A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers,~     measured by different cytokines.~   "
168232|NCT01363570|"~     Age Related Macular Degeneration (AMD) is the leading cause of blindness in North America.~     This condition causes a progressive loss of central vision, the part of your vision that~     allows you to read, drive and see images in sharp detail directly in front of you. The wet~     form of AMD is characterized by the growth and leakage of small blood vessels into the~     choroid layer of the eye, or the back of the eye. These leaking blood vessels disrupt the~     structure and function of the eye, causing loss of vision, particularly the sharp vision~     created by the macula area of the eye.~      Currently, the best treatment for wet AMD is a series of injections of an anti-vascular~     endothelial growth factor (anti-VEGF) drug, ranibizumab (Lucentis). The clinical response to~     treatment is varied. Approximately 70% of patients see a moderate vision gain (3-line gain on~     a visual acuity chart), but there are 30% who do not see a similar improvement in vision.~     There is no way to identify those patients who will respond with significant vision gain~     versus those who will not experience moderate vision gain. Recent research into AMD has~     demonstrated that genetic mutations are proving to be key risk factors for patients~     developing wet AMD, with up to 80% of wet AMD cases explained by inherited genetic~     variations. Scientists have theorized that there may be a genetic difference between those~     patients who see significant responses to treatment and those who do not. The investigators~     will be testing participant's genetic profile using the Macula Risk test and following their~     progress through the standard treatment for wet AMD over the course of this study. This study~     aims to demonstrate the association between known genetic variations and patient responses to~     treatment.~   "
168233|NCT01363557|"~     Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in~     addition to Gefitinib for the management of brain metastasis in lung cancer patients with a~     mutated EGFR.~   "
168234|NCT01363544|"~     Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that has a severe~     impact on a child's life and society. The core symptoms are attention problems, hyperactivity~     and impulsivity. These symptoms are related to disruptions in neurocognitive functions (such~     as inhibition: the ability to stop behavior) and disruptions in cortical regulation (such as~     'cortical underarousal' as measured with the electroencephalogram). To date, the only~     evidence-based treatment is pharmacological. Medication is not effective in 20-30% of the~     children with ADHD and it can have side effects. The lack of alternatives for medication is a~     severe problem for these children and society.~      Neurofeedback is becoming increasingly popular for treating ADHD. Neurofeedback is a training~     in which a person learns to alter its cortical regulation. Neurofeedback has been classified~     as 'probably effective' but its treatment effects need further empirical evidence. Non~     specific training effects, such as individual attention, may also contribute to treatment~     success. In this research project the investigators compare the efficacy of neurofeedback~     with exercise, a second non-pharmacological treatment, that may be comparable with~     neurofeedback in terms of non-specific effects. Exercise is also a promising treatment~     because of its positive effects on behavior, neurocognition in several patient groups. For~     these reasons, exercise deserves systematic research in ADHD. Furthermore, the investigators~     compare the efficacy of these two treatments with an optimal pharmacological treatment with~     methylphenidate (MPH). The main question is if neurofeedback and exercise are comparable in~     efficacy with MPH for treating ADHD. The primary outcome measure is behaviour (symptoms of~     ADHD). Secondary outcome measures include neurocognition and cortical regulation. This~     research project will give answer to the question if neurofeedback and exercise are as~     effective as MPH. Furthermore, it will give insight in how these interventions will give rise~     to improvements in behavior.~   "
168235|NCT01363531|"~     The general hypothesis is that delayed antibiotic treatment strategies present similar~     effectiveness, when compared with non-prescription of antibiotics or the prescription of~     antibiotics, in the non-complicated acute respiratory tract infections.~   "
168236|NCT01363518|"~     The subject's broken humerus (arm) is suitable for treatment with a fracture brace or~     operative fixation with plate and screws. Both of these types of treatments are often used by~     doctors to fix broken bones. If the subject agrees to participate in this study, the subject~     will be assigned by the treating surgeon to one of the following groups:~      Group B: Non-operative treatment with a fracture brace Group P: a plate & screws - a metal~     device placed on top of the bone.~      The investigators will collect information about the subject's arm fracture as it is treated~     with examinations and X-rays. X-rays will be obtained often in the first several months,~     depending on how the fracture is healing. This is determined by the doctor and will not be~     determined by the subject's participation in this research study.~      Both treatments are routinely used and this study hopes to provide information regarding each~     type of treatment on the subject's functional outcome. A subject's treatment will not be~     affected whether they choose to participate in this research study or not.~      The treatment of these subjects is no different because of this study. The treating surgeon~     will discuss with the patient their preferred treatment for the isolated humeral shaft~     fracture. If they meet the inclusion/exclusion criteria, they will be approached for~     participation in one of two treatment groups depending on a previous decision by the patient~     and the treating surgeon.~      Hypotheses:~        1. Patients with an isolated humeral shaft fracture that are plated will have a more rapid~          return to ADL's, work and full functional capacity than patients treated conservatively.~        2. Patients treated with plate technique will have a more rapid improvement in functional~          outcome scores, decreased pain scores and patient satisfaction than those managed~          conservatively.~        3. Complication rates of infection and iatrogenic neurologic injury will be higher in~          patients treated operatively.~        4. Nonunion and malunion will be higher in patients managed conservatively.~   "
168271|NCT01363050|"~     This was a phase 1, open label, multiple dose study in healthy male and female volunteers.~     Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for~     three days (seven doses in total). Doses were administered every eight hours.~      The objective of this study in healthy volunteers was to determine the safety, tolerability,~     and pharmacokinetics of multiple doses of intranasal ketorolac tromethamine.~   "
168272|NCT01363037|"~     The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and~     maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by~     healthy women in the United States.~   "
168237|NCT01363505|"~     Studies have shown that more than 30% of the overall acute decompensated heart failure (ADHF)~     patients develop renal dysfunction.~      Several studies have tried to find a correlation between hemodynamic Parameters (blood~     pressure , heart rate, central venous pressure CVP) and worsening of renal function in acute~     decompensated heart failure patients.~      Results showed that there were no correlation between baseline hemodynamics or change in~     hemodynamics and worsening of renal function.~      Another study showed that intra-abdominal pressure (IAP) measuring was a better corollary to~     renal failure status then measuring cardiovascular hemodynamics using pulmonary artery~     catheterization in ADHF patients.. An increased IAP was associated with worse renal function~     and that level of IAP far below abdominal compartment syndrome may adversely affect renal~     function in patients with ADHF.~   "
168238|NCT01363492|"~     The purpose of this study is to assess the safety of Replagal in children with Fabry disease~     who who have not previously been treated with enzyme replacement therapy (ERT).~   "
168239|NCT01363479|"~     PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of~     palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic~     drug), both given with oral dexamethasone. The objective of the study is to demonstrate that~     oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to~     prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24~     hours after administration of a single cycle of highly emetogenic chemotherapy.~   "
168240|NCT01363466|"~     GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional~     relapse, especially in patient with a reduced metastatic risk and who received a local~     chemoradiation therapy with an increase of radiotherapy doses (45 grays).~   "
168241|NCT01363453|"~     The aim of the non-interventional study is to document the daily doses in acute and remission~     therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage forms are~     added and, when and how long steroids are given.~   "
168242|NCT01363440|"~     The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection~     (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early~     treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema~     (DME) with central involvement.~   "
168243|NCT01363427|"~     The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine~     in recently diagnosed patients with Morbus Crohn by retrospective data collection.~   "
168244|NCT01363414|"~     Eyes with abnormal tear film function have been found to show larger optical aberrations than~     normal eyes which may be attributed to the unstable and irregular tear film, uneven ocular~     surface, and increased scatter due to the exposure of the rough surface of corneal epithelium~     after tear break-up.~      These hypotheses have been supported by the findings that instillation of artificial tears~     (sodium hyaluronate preparation) in dry eye patients reduces both corneal and ocular~     aberrations, improving the optical quality of the retinal image.~      However, the previous studies only evaluated the short-term effects of a single~     administration of an artificial tear but did not determine the duration of action or~     inflection point at which the ocular aberrations increase back to baseline. Also, there has~     clearly been no such clinical trial that has been a well randomized controlled study to date.~      This report is the first randomized controlled trial that investigated the long-term effects~     of a single dose of sodium hyaluronate-based artificial tears on wavefront aberrations in~     patients with dry eye.~   "
168245|NCT01363401|"~     The purpose of this study is to evaluate the safety and efficacy of autologous bone~     marrow-derived stem cells(HYNR-CS inj), through intrathecal delivery for the treatment in~     patients with ALS.~      This study consists of 2 steps. First step is a safety study of the intrathecal(IT) injection~     of HYNR-CS inj in 8 patients with ALS. In this phase 1 study, AE, laboratory test, physical~     examination, vital signs, Electrocardiogram, and Chest X-Ray examination were evaluated in~     terms of safety.~      Second step is to compare the efficacy and safety between test group and control group of~     total 64 patients with ALS.~   "
168246|NCT01363388|"~     The aim of this trial is to optimize the treatment to induce remission for patients with~     non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to~     reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating~     entirely the use of systemic corticosteroids during the induction period with an inhibitor of~     the complement C5a receptor plus cyclophosphamide or rituximab.~   "
168247|NCT01363375|"~     Excessive repetitive loading concentrating upon plantar fascia is considered as the most~     influential factor in plantar fasciitis development. Abnormal foot structure may lead to high~     risk of plantar fasciitis. However, the biomechanical factor that may cause plantar fasciitis~     has not been thoroughly investigated. Orthotic device is a common treatment used for plantar~     fasciitis. However, there is no direct and quantitative data, such as stress and strain~     distribution of plantar fascia for patient with foot orthosis during gait. Therefore, the aim~     of this three-year project study is to investigate the biomechanical mechanism of different~     foot structures and to understand the biomechanical response of plantar fascia during stance~     phase of gait cycle by dynamic finite element analysis, gait analysis as well as plantar~     pressure measurement. In addition, the efficacy of foot orthoses will be evaluated by the~     same research process. The hypotheses are that flat foot and high arch foot may result in~     higher stress and strain upon plantar fascia during gait; the foot orthosis, such as total~     contact insole, carbon fiber plate and rocker bottom sole, would reduce stress and strain~     distribution around the calcaneal medial tuberosity; rigid and curved geometric bottom will~     be able to relief plantar fascia stretching during push-off phase.~   "
168248|NCT01363362|"~     Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma~     patients. This study investigates, if there are changes in different ocular hemodynamic~     parameters prior and after SLT.~   "
168273|NCT01363024|"~     This is a multicenter, open-label, dose-escalation study to assess the safety, tolerability~     and Pharmacokinetics of MGFR1877S.~   "
168274|NCT01363011|"~     This study is to characterize the effect of cobicistat-based regimens on parameters of renal~     function in participants with HIV infection and who have mild to moderate renal impairment,~     and to assess the safety and tolerability of the regimens in order to generate appropriate~     dosing recommendations.~   "
168249|NCT01363349|"~     This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate the~     cognitive effects of treatment with CYP-1020 compared to risperidone. The primary efficacy~     endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy endpoints~     will occur after 12 and 24 weeks of treatment.~      Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study~     will utilize a flexible dose escalation scheme designed to allow patients to titrate to their~     maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a maximum of~     35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID (2-6 mg~     daily). To ensure effective blinding across all treatment groups, all patients will be~     treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy design).~   "
168250|NCT01363336|"~     This study is a post-marketing surveillance in Japan, and it is a local prospective, company~     sponsored and observational study of patient who have been treated by Adalat CR for~     hypertension with diabetes and/or chronic kidney disease. The objective of this study is to~     assess safety and efficacy profile of using Adalat CR in real clinical practice. A total~     2,000 patients will be recruited and be observed for 6 months. Then, patient of whom~     microalbumin urea and serum creatinine are continuously monitored are additionally followed~     for 6 months.~   "
168251|NCT01363323|"~     This study will employ a single-center, randomized, double-blind parallel-group design for~     MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm~     methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained~     after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to~     placebo.~   "
168252|NCT01363310|"~     Most individuals with major depressive disorder manifest clinically significant agitation.~     Concurrent agitation in a depressed individual is associated with an intensification of mood~     symptoms, decreased probability of recovery, increased recurrence risk, suicidality, and~     increased medical-service utilization. The occurrence of anxiety/agitation phenomenology in~     the depressed patient often invites the need for augmentation strategies (e.g. atypical~     antipsychotics, benzodiazepines, etc.) and complicated polypharmacy regimens. Moreover,~     individuals with major depressive disorder often report worsening of symptom severity,~     irritability, hostility, dysphoria, and significant subjective distress (This response~     pattern is similar to individuals with bipolar disorder).~      Results from large research studies provide evidence indicating that quetiapine is capable of~     offering clinically significant multidimensional symptom relief in bipolar depression.~     Moreover, results from several trials in major depressive disorder and generalized anxiety~     disorder have established the efficacy of quetiapine therapy for unipolar depression and~     anxiety syndromes. So far, no atypical antipsychotic agent has been evaluated specifically~     for the treatment of agitated depression.~      In this study, it is hypothesized that persons with major depressive disorder and prominent~     agitation (i.e. agitated depression) will exhibit a more favourable response and tolerability~     profile to quetiapine XR when compared to escitalopram.~   "
168253|NCT01363297|"~     The Phase 1 portion of this study will assess the safety, tolerability and efficacy at~     increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or~     refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2~     dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of~     inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in~     second or later salvage status.~   "
168254|NCT01363284|"~     The purpose of this study is to identify, prior to prescribing, which neuropathic pain~     patients will benefit from duloxetine more specific the investigators aims are to:~        -  Verify whether presence of chronic pain alters the pain modulation mechanisms, such as~          DNIC (diffuse noxious inhibitory control) and TS (temporal summation).~        -  Investigate whether anti-neuropathic medications such as duloxetine indeed change the~          pain modulation profile, and whether this profile change is associated with a reduction~          of clinical pain.~   "
168255|NCT01363271|"~     This is a retrospective, observational, non-interventional drug study using de-identified~     data from two administrative claims datasets. The study design and analysis will reflect the~     perspective of the commercially insured. The objectives of this study are twofold:~        1. To compare the rates of re-hospitalization among patients treated with either linezolid~          orally or IV, or vancomycin IV for complicated skin and skin structure infections~          (cSSSI) or pneumonia hospitalization.~        2. To compare the total direct medical costs of patients treated with linezolid orally or~          IV, or vancomycin IV for cSSSI or pneumonia hospitalization.~   "
168256|NCT01363258|"~     The main purpose of this study is to test a method of providing mouth care to persons with~     dementia who live in nursing homes. The method of providing mouth care is designed to reduce~     fear in persons with dementia, so that these persons do not resist mouth care.~   "
168257|NCT01363245|"~     The investigators plan to compare the effectiveness and cost effectiveness of an inpatient~     smoking cessation intervention for all smokers hospitalized at two urban public hospitals.~   "
168258|NCT01363232|"~     This is an open label, dose finding, phase Ib clinical trial to determine the maximum~     tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered~     phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2~     inhibitor MEK162. This combination will be explored in patients with epidermal growth factor~     receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR~     inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal~     cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or~     BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with~     overdose control. At MTD or RP2D, two expansion arms will be opened in order to further~     assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.~      Study drugs will be administered once daily orally on a continuous schedule. A treatment~     cycle is defined as 28 days.~   "
168259|NCT01363206|"~     The study is an open-label, single arm single Center Phase II study to evaluate the safety~     and efficacy of the combination of Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF,~     Leukine) and Ipilimumab (Yervoy) as therapy for patients with unresectable metastatic~     malignant melanoma.~   "
169501|NCT01346943|"~     The purpose of this study is to evaluate the safety of deploying and implanting the Altura~     Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in~     subjects who are candidates for open surgical aneurysm repair.~   "
168260|NCT01363193|"~     Standard weight-based IV heparin for normal weight patients is based on actual body weight~     (ABW). However, no well-defined guidelines have been established for patients considered to~     be obese or morbidly obese. In current practice, the calculated ABW based heparin initial~     bolus dose and infusion rates are quite high, and therefore often not used for obese/morbidly~     obese patients for fear of bleeding.~      Heparin is distributed in the body approximately the same as blood and does not get~     distributed to adipose tissue. There are some studies suggesting that lean body weight (LBW)~     might be a better basis for dosing heparin. LBW is a calculated weight that excludes the~     weight of fat.~      The investigators hypothesize that intravenous heparin dosing based on the Lean body weight~     of obese/morbidly obese patients would be safe and effective in achieving a therapeutic level~     of heparin in 24 hours compared to the usual practice in this patient population.~   "
168261|NCT01363180|"~     This project is the first to use a clinical laboratory method in emerging adults to test the~     hypothesis that a trauma history with or without concommitant posttraumatic stress disorder~     (PTSD) alters response to a stressor and promotes drinking compared to normal controls. The~     study will be the first to explore whether trauma-exposed (TE) and PTSD groups differ on~     these outcomes. It will also examine the relationship between stress reactivity and~     subsequent stress-induced drinking in these samples. The goal of this program is to better~     understand the relationship between stress and factors related to the development and~     maintenance of alcohol problems in early adults, so that ultimately, better treatments may be~     developed that reduce the incidence and severity of alcohol related problems.~   "
168262|NCT01363167|"~     This study is to determine the amount of vitamin D required for a very low birth weight~     infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.~   "
168263|NCT01363154|"~     The purpose of this clinical trial is to examine the effect of non-invasive cortical~     activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two~     Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has~     indicated that such evoked activity (i.e. by specific music) can result in significant~     reductions, or even complete termination of epileptiform activity and/or seizures across a~     broad range of individuals with epilepsy. A hypothesis is generated that specific music~     activation would beneficially effect photoparoxysmal based epileptiform abnormalities.~   "
168264|NCT01363141|"~     The investigators have previously demonstrated that Advanced Glycation End products (AGEs)~     are associated with several chronic diseases in humans and that blood AGE levels can be~     significantly reduced by simply changing the way food is cooked.~      This is an interventional-randomized study in which we are trying to determine whether a diet~     low in AGE followed for 1 year can effectively reduce circulating AGE levels as well as~     markers of the metabolic syndrome in a group of patients with these abnormal markers.~   "
168265|NCT01363128|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if ofatumumab combined with standard~     chemotherapy can help to control acute lymphoblastic leukemia (ALL). The safety of these drug~     combinations will also be studied.~      This is an investigational study. Ofatumumab is FDA approved and commercially available for~     the treatment of chronic lymphocytic leukemia. Its use to treat ALL is investigational.~      Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.~   "
168266|NCT01363115|"~     The objective of this study is to investigate the effect of calcium (Ca) and vitamin D (D)~     supplemented orange juice (OJ) on weight loss and visceral fat mass in overweight and obese~     adults.~   "
168267|NCT01363102|"~     The investigators hypothesize that by applying a validated algorithm to accomplish early~     mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a~     higher level of mobility which translates to shorter ICU length of stay and improved~     functional status at discharge. Additionally, the investigators hypothesize that genetic~     polymorphisms related to muscle strength and sleep will also explain some variance in these~     outcome variables.~   "
168268|NCT01363089|"~     This was an open label, two way crossover study in healthy male subjects. Two treatments were~     administered to each subject, one treatment per study period, in a randomized manner.~     Subjects remained resident in the Clinical Unit from the evening of Day 1 until the morning~     of Day 2 of each period and there was a washout period of at least 2 days between treatments.~     A post study medical examination was performed prior to discharge in Period 2.~      The objective of this study was to assess the effects of a single dose of intranasal~     oxymetazoline hydrochloride on the pharmacokinetics of intranasal ketorolac in healthy male~     subjects.~   "
168269|NCT01363076|"~     This was an open-label PK study in pediatric subjects who had undergone general surgery. Each~     subject's study participation consisted of a screening visit, a single-dose treatment with~     intranasal ketorolac (IN) tromethamine, and a follow-up visit.~      Following surgery, subjects received IN ketorolac 15 mg (weight < 50 kg) or 30 mg (weight >~     or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the~     subjects had access to an opioid analgesic administered by patient-controlled analgesia~     (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points~     following the dose of ketorolac.~   "
168270|NCT01363063|"~     This was a Phase 1, double blind, two part study in healthy male and female volunteers. Each~     subject participated in only one part of the study. In Part A subjects received one dose of~     15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril~     and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the~     other nostril, in a randomized manner. In Part B subjects were randomized to receive a single~     intranasal dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into~     one nostril and either placebo or a single intranasal dose of 15 mg ketorolac tromethamine~     containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril. During the study,~     subjects remained resident from the morning of Day 1 until the afternoon of Day 1, when a~     post-study medical was performed prior to discharge.~      The objective of this study was to compare the tolerability of formulations of ketorolac~     tromethamine with differing concentrations of lidocaine hydrochloride (0% and 6% in Part A~     and 0%, 4%, 6% and placebo in Part B) following intranasal administration to healthy~     volunteers.~   "
171919|NCT01315015|"~     The purpose of this study is to determine the cost-effectiveness of biennial screening with~     mammography and MRI compared to mammography alone in women aged 50-75 years and who show >~     75% mammographic density.~   "
168275|NCT01362998|"~     For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot~     epidural preservative free morphine with a continuous epidural fentanyl infusion. The~     investigators will be comparing the patient's pain level and satisfaction with the two~     techniques, as well as the side effects that the patients experience, such as itching,~     nausea, back pain and respiratory depression.~   "
168276|NCT01362985|"~     Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the~     European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of~     plerixafor will be collected for data entered over a 5 year time span (i.e., data entered~     into the registry between the date of European Union (EU) marketing authorization [31 July~     2009] and 31 July 2014).~      The EBMT is a non-profit, scientific society representing more than 600 transplant centers~     mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation~     or cellular therapy, which includes registering all the activity relating to stem cell~     transplants. Data are entered, managed, and maintained in a central database with internet~     access; each EBMT center is represented in this database.~      The collection by the EBMT registry of reasons for the off-label transplant use of plerixafor~     shall provide information of a substantial number of patients who are representative of the~     patient population receiving plerixafor off-label.~   "
168277|NCT01362972|"~     In the European Union (EU), plerixafor is indicated in combination with granulocyte colony~     stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells (HSCs) to the~     peripheral blood (PB) for collection and subsequent autologous transplantation in patients~     with lymphoma and multiple myeloma (MM) whose cells mobilise poorly.~      This is a clinical outcome analysis of a prospectively defined cohort of patients with data~     reported retrospectively to the European Group for Blood and Marrow Transplantation (EBMT)~     who have lymphoma or multiple myeloma (MM), whose cells mobilize poorly, and who have~     undergone autologous haematopoietic stem cell (HSC) transplantation during the years 2008 up~     to and including 2012.~      The EBMT is a non-profit, scientific society representing more than 600 transplant centers~     mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation~     or cellular therapy, which includes registering all the activity relating to stem cell~     transplants. Data are entered, managed, and maintained in a central database with internet~     access; each EBMT center is represented in this database.~      The analysis of data from a well established registry like the EBMT registry allows for~     follow up of a large number of patients who are representative of the patient population~     receiving plerixafor.~   "
168278|NCT01362959|"~     The purpose of this study is to determine whether transdermal nicotine replacement therapy is~     safe and effective for treating nicotine withdrawal symptoms in the critically ill smoking~     patient.~   "
168279|NCT01362946|"~     The purpose of this study is to modify behavior therapy so that it is optimized for children~     with conduct problems and callous-unemotional traits by emphasizing reward components and~     de-emphasizing punishment components.~   "
168280|NCT01362933|"~     Treatment of venous thromboembolism in cancer patients is specific and has been validated in~     trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K~     Antagonist) treatment during 6 months. International recommendations have diffused this~     option.It is necessary to evaluate the compliance of physicians to this treatment by~     measuring the number of patients with cancer treated with long term use of LMWH.~   "
168281|NCT01362920|"~     In 2005, the Food and Drug Administration (FDA) approved procalcitonin in conjunction with~     other laboratory markers to aid in the risk assessment of critically ill patients with severe~     infection (sepsis). Although considerable literature exists regarding the usefulness of~     Procalcitonin (PCT) as a marker of sepsis, there are still potential uses for PCT~     measurements that are not yet explored and its value among the critically ill patients~     remains unclear. This study seeks to better understand the usefulness of measuring PCT values~     in patients admitted to the Medical ICU for a variety of reasons and in particular with~     severe infection (sepsis).~   "
168282|NCT01362907|"~     The purpose of this trial was to compare the performance of an investigational daily~     disposable contact lens to a commercially available daily disposable contact lens.~   "
168283|NCT01362894|"~     The purpose of this trial was to compare the performance of two contact lenses commercially~     available for people with astigmatism.~   "
168284|NCT01362881|"~     It is current practice for children who have surgery for early onset scoliosis (EOS) to be~     treated with insertion of extendable implants known as growth rod systems. This allows the~     growth potential of the child to be maximised during the period of growth. However, the child~     must undergo an average of 6 further surgeries to lengthen the rods every 6 months. Sometimes~     this may continue for several years. This requires repeated general anaesthesia and places~     the patient at risk of complications as well as on-going costs to the hospital with each~     admission and theatre episode.~      Magec is a magnetic growth rod from Ellipse technologies (distributed by SurgiC). The rod is~     inserted in exactly the same way as the conventional growth rod systems. The base implants~     i.e screws and hooks remain the preferred choice of the user. The only change is that a~     different rod is used.~      There are several advantages to this device. Firstly, after the initial insertion, further~     lengthenings, unlike current systems, do not need to be carried out in theatre under a~     general anaesthetic. In contrast, they can be done in an outpatients setting with a~     non-invasive technique. The rods are lengthened using an external magnetic device. The~     lengthenings are done in a controlled manner using an age related growth guide. Thirdly, the~     change from a theatre based intervention to an outpatient procedure will have cost-savings.~     The investigators also believe that there will be psychosocial benefits to the child and~     family by the avoiding the stress associated with repeated surgery at such a young age.~      In terms of risk assessment the device does not place the child at any more risk than would~     be expected from inserting any of the existing systems. In the event of failure of the rods~     the worst outcome is a revision to conventional rods.~   "
168285|NCT01362868|"~     The purpose of this study is to investigate the investigational device capacity to detect an~     intraocular pressure increase (IOP)induced by water intake.~   "
168286|NCT01362855|"~     The purpose of the study is to inform decision-makers of the best strategies to implement~     advanced care planning (ACP).~      An advanced care plan (ACP) is a verbal or written instruction describing what kind of care~     an individual would want (or not want)if they are no longer able speak for themselves to make~     health care decisions.~   "
168287|NCT01362842|"~     The lung cancer is the most has the life minacity in all kinds of cancers, and it also~     remains the most common cause of cancer-related death in the world. The group of lung cancer~     patients are suffer from huge disease impact that came from high mortality. Not only the~     course of treatment that patients has been diagnosis through operation is more faster, but~     also those who could be capable of operated are stabilized to keep follow-up at out-patient~     clinic. But in the next following five years after operation, they may take different~     dysfunctional level or some kinds of symptom distress. The effect has a great influence on~     those patients that have to face extended emotional impact, symptom distress and life style~     change. In addition, most of them concern about recurrent all the time in the remission.~     These situation needs us to place importance on it.~      The purposes of this study are to investigate psychological and physical distress and care~     needs in operable lung cancer patients receiving surgery. This survey includes two parts of~     physical and mental condition. First, the investigators are scoring their symptom severity~     and quality of life to check physical condition. Seconded, the mental condition will use~     validated questionnaires to realize the relationship of anxiety, depression, uncertainty,~     fear of recurrence, self-efficacy and needs. Final, compare all of the data to patients'~     needs.~      This study is a cross-sectional designs with convenience sampling that conform to the~     investigators recruited requirements. The investigators will recruit from the clinic of~     thoracic surgery in one medical center in Taipei and take five structured requirements. And~     the investigators are going to collect data from January, 2011 to December, 2012. Also expect~     results are lung cancer outpatients after surgery that more physical dysfunction or more~     depress of mental condition, it will lead patients' needs increased or significant~     difference. In conclusion, this study analyzes their needs in the remission that consequences~     can be medical professionals' reference material.~   "
168288|NCT01362829|"~     The investigators perform a prospective observation study to search for the outcome~     predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.~   "
168289|NCT01362816|"~     The rising incidence of cancer and the rapidly increasing number of people living longer with~     incurable disease, accentuates the need for optimal symptom management throughout the disease~     trajectory. Thanks to the medical and technological development, and the increased interest~     in palliative care research, palliative medicine has gradually become more evidence based.~     Patients with advanced cancer experience multiple symptoms at the time with fluctuating~     intensity and severity. Pain, fatigue, nausea/vomiting, dyspnea, loss of appetite and~     depression are among the most common and experienced by more than 50%. However, the~     prevalence rates of these symptoms vary considerably across studies, with a range from 35 to~     90 % for pain as an example. These differences may in part be explained by different~     assessment tools, study methods and design and population characteristics. There is also lack~     of agreed-upon, common criteria to describe the main characteristics of a palliative care~     cancer population and few standardized tools for assessment and classification of symptoms~     exist. These shortcomings limit the possibility to design randomized controlled treatment~     trials in palliative care; the optimal way to improve clinical symptom management. To do~     this, a better understanding of how symptoms evolve and how they should be assessed and~     classified throughout the palliative care disease trajectory is important, supplemented with~     registrations of the treatment provided. The primary aim of this international research~     project the European Palliative Care Cancer Symptom study (EPCCS) is to extend the knowledge~     about and gain new insight in the prevalence and development of the most frequent cancer~     related symptoms during the course of disease, in a large sample of palliative care cancer~     patients. The clinical usefulness of the new assessment and classification system developed~     by the European Palliative Care Research Collaborative (EPCRC) / European Association for~     Palliative Care Research Network (EAPC RN) will be examined and data on the organization and~     delivery of palliative care at participating centers will be collected. The project also aims~     to further develop and consolidate international research collaboration through the European~     Palliative Care Research Centre (PRC). Taken together, these efforts will increase the~     understanding of the palliative disease trajectory and provide necessary knowledge and~     structure for future randomized controlled trials (RCTs)~   "
168290|NCT01362803|"~     Background:~      - Plexiform neurofibromas are tumors that grow in and around nerves. The only way to treat~     them is with surgery. Some of these tumors cannot be completely removed. The tumors may be~     too large, too numerous, or in a bad location for surgery. An experimental drug called~     AZD6244 hydrogen sulfate may be able to prevent the tumors from growing, slow down their~     growth, or shrink them. This drug has been tested in adults with cancer and in children with~     some types of brain cancer. This study will test how well this drug works with these types of~     tumors.~      Objectives:~      - To study the safety and effectiveness of AZD6244 hydrogen sulfate in children and young~     adults with plexiform neurofibromas that cannot be completely removed by surgery.~      Eligibility:~      - Children and young adults between 12 and 18 years of age who have plexiform neurofibromas~     that cannot be completely removed by surgery.~      Design:~        -  Patients will be screened with a physical exam, medical history, blood tests, and~          imaging studies.~        -  They will take the study drug twice a day with 8 ounces of water, every day for 28-day~          cycles of treatment. During study visits, participants will have blood and urine tests~          and physical exams. They will also have imaging studies to examine the tumor sizes and~          locations. They will answer questions about their health. They may have other tests as~          needed.~        -  Participants will continue to receive the study drug as long as they have no severe side~          effects and the disease is not getting worse.~   "
168291|NCT01362790|"~     Background:~        -  Malignant mesothelioma is a form of cancer that develops on the protective lining that~          covers the body s internal organs. It most often occurs on the lining of the lungs and~          chest wall or the lining of the abdomen. There is no known cure for malignant~          mesothelioma, so researchers are searching for new ways to treat it.~        -  Mesothelin is a protein that is found in mesothelioma and other types of cancer cells.~          An experimental cancer drug called SS1P is designed to attack cells that have mesothelin~          while leaving healthy cells alone. Researchers want to test how effective SS1P is when~          it is given with pentostatin and cyclophosphamide. These drugs help suppress the immune~          system and may make the SS1P more effective.~      Objectives:~      - To study the effectiveness of SS1P plus two drugs that suppress the immune system to treat~     malignant mesothelioma.~      Eligibility:~      - Individuals at least 18 years of age who have malignant mesothelioma in the chest or~     abdomen.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~          They will also have imaging studies.~        -  The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment will~          follow.~        -  In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will~          have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14.~        -  On the next three cycles, participants will have pentostatin on day 1.They will have~          cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6.~        -  Participants will have frequent blood tests and other studies. They will receive all~          four cycles of treatment as long as there are no severe side effects.~        -  Participants will have regular followup visits as directed by the study doctors.~   "
168292|NCT01362777|"~     The obstructive sleep apnea/hypopnea syndrome (OSAS) is a common disease (2-4% of the general~     population) that generates intermittent hypoxemia and sleep fragmentation. OSAS is associated~     with various metabolic disorders such as metabolic syndrome, type 2 diabetes. OSAS is a risk~     factor for cardio-vascular diseases by increasing morbidity/mortality. OSAS patients suffer~     from excessive daytime sleepiness (EDS), a symptom also responsible for at least 30% of~     traffic accidents but also other cognitive disorders with significant impact on quality of~     life. OSAS generates oxidative stress, inflammation and resistance to insulin and other~     systemic metabolic dysregulation of many whose levels are correlated with the severity of the~     disease.~      Treatment with Continuous Positive Airway Pressure (CPAP) has clearly demonstrated its~     effectiveness to eliminate apneas and improve EDS but it is sometimes difficult to accept~     and/or poorly tolerated, limiting its effectiveness.~      Weight loss and regular physical activity are clearly recommended but rarely done in clinical~     practice. A few studies have applied to study the effects of rehabilitation training (REE) on~     the sleep apnea patients and have shown an improvement in sleep quality, reduction of~     awakenings and arousals from sleep and the Index of Apnea/Hypopnea (AHI), but their~     methodology was questionable, and the number of patients included was too low.~      The investigators hypothesis is that an in-patient multidisciplinary rehabilitation program~     comprising educational activities, dietary management and individualized exercise training~     (IET) will decrease OSAS severity, improve sleep quality and symptoms (EDS, fatigue, QoL).~     This IET program (24 sessions during 4 weeks) could also help to improve many metabolic~     dysregulation, inflammation and oxidative stress (also markers of cardiovascular risk).~     Leptin, a hormone involved in regulating appetite, energy expenditure and ventilatory control~     is increased in OSA (mechanism of leptin resistance). The improved sensitivity to leptin may~     play a role in enabling a better control of ventilation in these patients.~   "
168293|NCT01362764|"~     The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is~     absorbed in the body, distributed within the body, and how it is removed from the body) of~     the solution formulation to the tablet formulation; therefore the lowest dose available in~     the tablet formulation (250 mg) was selected.~   "
168294|NCT01362751|"~     In this study the investigators aimed~        1. to investigate the prevalence of orthostatic hypotension in elderly nursing home~          residents.~        2. to investigate whether the presence of orthostatic hypotension influences the chance of~          successful rehabilitation.~   "
168295|NCT01362738|"~     The purpose of this prospective randomized study is to assess whether empirical Left Atrial~     Appendage (LAA) isolation along with the standard approach of pulmonary vein isolation (PVI)~     and ablation of extra-pulmonary triggers is superior to the standard approach alone in~     enhancing the long-term success rate of catheter ablation in persistent or long-standing~     persistent atrial fibrillation (AF) patients.~   "
168296|NCT01362725|"~     The primary objectives of this feasibility study are to determine the safety of spinal cord~     stimulation (SCS) as a therapy in patients with systolic heart failure and to gather~     observational information for potential efficacy markers~   "
168297|NCT01362712|"~     This trial will be the first trial for the IP, [F-18]CP-18, and will be conducted as an~     exploratory Phase I trial designed to collect information as this IP is administered and~     evaluated for the first time in humans. The trial will evaluate safety, biodistribution and~     dosimetry data in normal subjects and the trial will evaluate safety, biodistribution and~     tumor to background imaging data, and correlate image data with caspase 3 activity level on a~     surgical specimen analyzed by immunohistochemistry in the cancer subjects. All study results~     will be evaluated and analyzed in order to consider the design for future clinical trials.~     The information collected under this exploratory, Phase I study will not be used for~     diagnostic purposes, to assess the subject's response to therapy, or for clinical management~     of the subject.~   "
168298|NCT01362699|"~     The purpose of this study is to assess whether JNJ-31001074 taken for 7 days reduces the urge~     to drink alcohol in alcohol-dependent study participants who are not seeking treatment.~   "
168299|NCT01362686|"~     Conduct a comparative effectiveness clinical trial of medication treatment for behavioral~     symptoms of Alzheimer's disease in a group of real-world memory care clinics with enhanced~     access to the Indiana Network for Patient Care.~   "
168300|NCT01362673|"~     This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed~     to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of~     PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed~     conditions.~   "
168301|NCT01362660|"~     This study will examine post-natal neurologic and cognitive development of infants who may~     have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program~     (whether the exposure is through maternal or paternal participation in a tanezumab clinical~     study).~   "
168302|NCT01362647|"~     Several studies have documented that neuromuscular block often persists in the postanesthesia~     care unit (PACU). Residual paralysis is associated with postoperative complications such as~     hypoxia, weakness, and respiratory failure. The data in the current literature on residual~     paralysis in the PACU were almost exclusively obtained with acetylcholinesterase inhibitors~     as they were the only reversal agents available prior to the introduction in clinical~     practice of sugammadex (Bridion®) in the European Union and in some other countries, except~     for the USA. Reassessment of practice in this regard is relevant, now that sugammadex~     (Bridion®) has become available in our country since 2009.~      This study is an observational/non-interventional, non-randomized study involving adult~     patients undergoing different types of elective surgical procedures requiring general~     anesthesia with neuromuscular blocking drugs (NMBDs). Administration of NMBDs and reversal~     agents (as well as all drugs which will be used during anesthesia) will be performed in~     accordance with routine anesthetic practice.~      The study population will comprise about 600 surgical patients. Immediately after the~     patients' arrival in the PACU, a study nurse will record the acceleromyographic responses of~     their adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the~     ulnar nerve. A TOF of 90% will be used as cut-off value to exclude residual paralysis. Pulse~     oximetry (SpO2) will be measured continuously throughout the PACU admission, and SpO2 values~     will be recorded at 1-min intervals for the first 30 min. PACU nurses caring for the patient~     will document the occurrence of any of the following events during the first 30 min of PACU~     admission: the number of episodes of hypoxemia (SpO2<90%), the lowest SpO2 observed by~     nursing staff, the requirement for either tactile or verbal stimulation to maintain SpO2~     greater than 90%, and any clinical evidence of airway obstruction.~      The primary objective is to evaluate the incidence of postoperative residual curarisation at~     PACU arrival in patients reversed with sugammadex (Bridion®), neostigmine and in case of~     spontaneous recovery.~      The secondary objectives are to evaluate:~        -  Oxygen saturation (SpO2) at PACU arrival~        -  Possible episodes of SpO2 <90% in the PACU~        -  Airway maneuvers and/or stimulation required to maintain SpO2 >90% in the PACU~        -  Need for re-intubation.~   "
168303|NCT01362634|"~     The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be~     randomly assigned (using a random number table) to the interviewer-administered intervention,~     the self-administered intervention, and waitlist control conditions upon completion of~     screening, informed consent, HIV pretest counseling and test administration, and collection~     of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.~   "
168304|NCT01362621|"~     The study was designed to collect data about inadequately controlled moderate to severe~     allergic asthma in subjects 6 to < 12 years of age, managed in a real-world setting.~   "
168305|NCT01362608|"~     The purpose of this pivotal Phase III study is to support the registration of canakinumab for~     the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by~     demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are~     contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout~     flares relieves the signs and symptoms and prevents recurrence of gout flares compared to~     triamcinolone acetonide 40 mg i.m.~   "
168306|NCT01362595|"~     This study will determine the safety and possibility of giving the amino acid, leucine, in~     patients with Diamond Blackfan anemia(DBA)who are on dependent on red blood cell~     transfusions.~      The leucine is expected to produce a response in patients with DBA to the point where red~     blood cell production is increased. Red cell transfusions can then be less frequent or~     possibly discontinued.~      The investigators will study the side effects, if any, of giving leucine to DBA patients.~     Leucine levels of leucine will be obtained at baseline and during the study.~      The drug leucine will be provided in capsule form and taken 3 times a day for a total of 9~     months.~   "
168307|NCT01362582|"~     A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic~     adenocarcinoma receiving defined second or higher line chemotherapy and additionally~     parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).~   "
168308|NCT01362569|"~     Chronic kidney disease is widespread in the western world with bacterial infection and sepsis~     as common complication. It has been shown that innate immune defence, represented by~     dysfunction of neutrophil granulocytes, is impaired in chronic kidney disease. Another impact~     of chronic kidney disease on innate immunity is the chronic activation of neutrophils leading~     to high levels of inflammatory cytokines, thus contributing to protein oxidation. Oxidation~     of human serum albumin (HSA), the major plasma protein, occurs in chronic kidney disease and~     leads to further activation of neutrophils. Another important impact of HSA oxidation is the~     decrease of its binding capacity leading to impaired detoxification ability of albumin. This~     includes reduced clearance of endotoxin, a major component of the gram negative bacterial~     cell wall. Circulating endotoxin is recognized by complex formation with lipopolysaccharide~     binding protein (LBP) followed by binding to CD14 and toll-like receptor (TLR) 4. High~     systemic endotoxin levels occur in chronic kidney disease and may be the result of decreased~     clearance ability of HSA and increased gut permeability in combination with intestinal~     bacterial overgrowth. High systemic endotoxin is associated with worse outcome in several~     diseases and could be used as predictor for mortality in chronic kidney disease patients.~      Endotoxemia in renal insufficiency leads to impaired neutrophil function and to increased~     albumin oxidation. Oxidized albumin is not able to bind endotoxin adequately any more, which~     leads to a further increase in oxidative stress and neutrophil dysfunction, resulting in a~     vicious cycle.~      195 patients with renal dysfunction will be enrolled and divided into 5 groups. Additionally,~     samples of 25 age and sex-matched healthy controls will be collected.~      This concept will change the understanding of several aspects of chronic kidney disease and~     will potentially help to stratify patients into different groups at risk according to their~     endotoxin status, and their immune and albumin dysfunction. The results of this study will~     have important implications into the development of novel therapeutic strategies~   "
168309|NCT01362556|"~     The debate over the administration of sodium bicarbonate in cardiac arrest has been going on~     for several decades, swinging like a pendulum from first-line drug to not indicated to~     the recent guidelines advocating a small bolus under special conditions (metabolic acidosis,~     intoxication, long-term resuscitation). A targeted, blood-gas controlled application under~     optimised ventilation conditions has not yet been evaluated prehospitally. Our preliminary~     studies have shown that an arterial puncture/line as well as measurement of blood gases is~     feasible in preclinical conditions. This multicentre trial including 5 centres and 10~     physician-staffed emergency systems is designed to compare, in a prospective randomised~     controlled study, the effect of a calculated dosage of sodium bicarbonate based on the~     patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and on the~     secondary survival of cardiac arrest patients. The null hypothesis is that there is no or~     negative impact on survival.~   "
168310|NCT01362543|"~     The Competence Centre for Transcultural Psychiatry is a clinic specialised in the treatment~     of traumatised refugees. There is a lack of studies on treatment effect in traumatised~     refugees. There are several studies indicating an effect of cognitive behavioural therapy~     (CBT) in Posttraumatic Stress Disorder (PTSD). A few studies point to that CBT could be~     effective in traumatised refugees. There are no studies examining if some methods used in CBT~     are more useful than others in traumatised refugees. The aim of this study is to examine the~     effect of CBT with focus on Stress Management versus cognitive restructuring. Patients~     included in this study will be randomised to either Stress Management or cognitive~     restructuring. All referred patients will receive medical treatment as usual (described in~     the clinic's manual for medical doctors, 2011). All patients that fulfill the inclusion~     criteria will be included in the study. Hopefully this study will contribute to improve the~     psychotherapeutic treatment offered to traumatised refugees.~   "
168311|NCT01362530|"~     This study will compare the safety and efficacy of a three-day oral aprepitant regimen~     (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced~     nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in~     pediatric participants. Those who complete this first cycle of treatment and meet certain~     eligibility criteria will have the option of continuing for 5 additional cycles of open-label~     aprepitant.~   "
168312|NCT01362517|"~     The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine~     (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H.~     influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4~     months of age according to the local Expanded Programme on Immunisation (EPI) schedule~   "
168313|NCT01362504|"~     The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level~     in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this study.~     Eighty healthy matched neonates served as a control group.~   "
168314|NCT01362491|"~     This study will compare the ability of a single-dose of a novel ibuprofen formulation to~     relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type~     headache~   "
168315|NCT01362478|"~     Schizophrenia is a disabling mental disease affecting about 1% of the worldwide population.~     There is an overall heritability estimate of 68% for the underlying liability to~     schizophrenia. Molecular epigenetic studies can overcome the complexities of traditional~     genetic studies and provide a new framework for the search of etiological factors in~     schizophrenia.~      DNA methylation provides an example of an epigenetic process that affects gene expression.~     Several postmortem experiments have found that increased DNA methylation at the glutamic acid~     decarboxylase (GAD67) and reelin promoter, and hypomethylation of membrane-bound~     catechol-O-methyltransferase (MB-COMT) promoter gene in prefrontal cortex of schizophrenia~     patients.~      Because it is impossible to obtain brain tissue from schizophrenia patients clinically, the~     peripheral blood mononuclear cell (PBMC) can partly represent the brain gene expression. It~     has been reported to use PBMC as biomarkers for epigenetic abnormalities, such as histone~     acetylation and methylation, in schizophrenia. To the investigators best knowledge, gene~     promoter DNA methylation abnormalities in schizophrenia have been limited to postmortem~     study. It warrants to studying the DNA methylation using schizophrenia's PBMC.~      Recently, endophenotype strategy has emerged as an important tool in understanding the~     genetic architecture of schizophrenia. Some cognitive functions, such as attention and~     working memory (WM), have been used as candidate endophenotypes for genetic studies in~     schizophrenia. Synchronized GABA neurotransmission in the dorsolateral prefrontal cortex is~     required for adequate attention and working memory, suggesting that impairments in~     GABA-mediated inhibition in the prefrontal cortex could contribute to the endophenotype~     presentations in schizophrenia.~   "
168316|NCT01362465|"~     This study is an effort to use left ventricular (LV) lead based measurements to identify late~     electrical activation and avoid scar.~   "
168505|NCT01359982|"~     The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001~     for injection in subjects with advanced solid tumors or lymphomas for which there are no~     currently accepted curative therapies. This study will also conduct an exploratory evaluation~     of objective tumor response using CT or MRI.~   "
168317|NCT01362452|"~     The goal of this clinical research study is to learn if an infusion of white blood cells~     (called T cells) that have been genetically changed is safe to give patients who have~     received an umbilical cord blood transplant (UCBT). Researchers want to learn if these~     genetically changed T-cells are effective in attacking cancer cells in patients with advanced~     B-cell lymphoma or leukemia after they have received an UCBT, how long the changed T-cells~     stay in the body, and if adding them to standard transplant could improve how patients~     respond to treatment.~      Funding Source - FDA OOPD~   "
168318|NCT01362439|"~     The purpose of this study is to evaluate the effectiveness and safety of paliperidone~     extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder~     with symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self) who were receiving treatment with any oral~     (having to do with the mouth) antipsychotic medication and who needed to be switched to~     paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or~     due to side effects.~   "
168319|NCT01362426|"~     The primary objective of this study is to determine if Australian patients with schizophrenia~     treated with paliperidone palmitate under conditions of continuous monitoring of outcomes~     over a 12-month period achieve relapse rates comparable to published literature.~   "
168320|NCT01362413|"~     The aim of the study is to determine whether the evaluation of pro-osteogenic activity of~     autologous serum may predict the effectiveness of platelet gel in regenerating bone tissue in~     patients with nonunions of long bones.~      Serum samples will be collected before the surgery, and their pro-osteogenic activity will be~     evaluated by using a bioactivity test (mineralization assay).~      In order to determine whether the pro-osteogenic activity of the serum is able to~     discriminate between individuals who will achieve or will not achieve bone consolidation, the~     laboratory results will be correlated with clinical and radiographic results at 12 months,~     when patients will be considered as healed or not healed.~   "
168321|NCT01362400|"~     The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel~     to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell~     Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of~     the study is to determine the effect of IPI-504, in combination with docetaxel, verses~     placebo in, combination with docetaxel, on the growth of cancer~   "
168322|NCT01362387|"~     Purpose: This randomised trial will compare outcomes and acceptability of an alternative~     medical abortion follow-up protocol using standardised text messaging, on-line questionnaire,~     or a phone interview and a low sensitivity pregnancy test with the current standard of care~     which consists of either a clinic visit and ultrasound scan or a telephone call and high~     sensitivity pregnancy test.~      Hypothesis: The use of alternative methods to assess outcomes after early medical abortion~     will achieve a higher rate of follow-up than women undergoing standard follow-up~      Primary aim: To determine the follow-up rate after early medical abortion with an alternative~     protocol as compared to a standard follow-up protocol~      Secondary aims:~        -  To assess complication rates and receipt of further treatment among women in the two~          study arms~        -  To ascertain women's preferences for mode of communication regarding their post-medical~          abortion status~        -  To determine provider opinions and preferences for different follow-up modalities~   "
168323|NCT01362374|"~     This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the~     safety, tolerability, and pharmacokinetics of oral GDC-0068 administered in combination with~     either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU) (mFOLFOX6~     chemotherapy) (Arm B), or paclitaxel (Arm C), in participants with advanced or metastatic~     solid tumors for which standard therapy either does not exist or has proven ineffective or~     intolerable. Arm D will assess the safety, tolerability, and pharmacokinetics of GDC-0068~     administered in combination with enzalutamide in participants with metastatic~     castration-resistant prostate cancer (CRPC). There will be two stages within each arm of this~     study: a dose-escalation stage (Stage 1) and a cohort-expansion stage (Stage 2). In Stage 1,~     approximately 3 to 6 cohorts in Arms A and B and 1 to 2 cohorts in Arms C and D will be~     evaluated to determine the maximum tolerated dose (MTD) of GDC-0068 in a given combination.~     Additional participants will be enrolled in Stage 2 (cohort expansion), to further~     characterize the safety and tolerability of GDC-0068 in these combinations and to confirm a~     potential recommended Phase II dose of GDC-0068 for each regimen.~   "
168324|NCT01362361|"~     The purpose of this study:~      To explore the comparative effectiveness of BIBF 1120 in terms of :~        -  Progression-free survival (PFS), objective response, overall survival~        -  Evaluate and compare safety~   "
168325|NCT01362348|"~     The purpose of this 12 week, open-label study is to investigate the safety and efficacy of a~     single dose regimen of pazopanib eye drop for neovascular AMD.~   "
168326|NCT01362335|"~     In many surgical procedures, anaesthesiological care is provided according to the best~     scientific and clinical information available. However, since hemodynamic monitoring until~     recently did not allow for beat-to-beat information of the haemodynamical changes, many~     fast-changing events may have been unnoticed or have not been investigated as precisely as is~     possible today. Moreover, in several surgical procedures - like eye surgery - the~     invasiveness of the classical haemodynamical monitoring devices was of such a degree that~     until now, in these circumstances these vital parameters were not investigated yet.~      Therefore, the availability of this new device, which allows for noninvasive beat-to-beat~     assessment of these haemodynamical parameters gives a unique opportunity to investigate our~     anaesthesiological management and to elucidate whether improvements are desirable and~     possible.~      The Nexfin monitor consists of a cuff-micromanometer that is located around the third finger.~     It simultaneously uses continuous pressure readings and light-absorption spectrometry to~     determine valuable haemodynamical information. Data is recorded and available for subsequent~     offline analysis.~   "
168327|NCT01362322|"~     The purpose of the study is to compare the immunogenicity and safety of a booster dose of~     BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in~     the previous syringe presentation in healthy adolescents aged 10-15 years.~   "
168506|NCT01359969|"~     This open-label study is being conducted to confirm the safety, pharmacokinetic profile and~     efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema~     attacks in patients, from 2 up to and including 13 years of age.~   "
168328|NCT01362309|"~     There is considerable evidence that Alcohol Use Disorders (AUDs) can be understood as a form~     of dysregulated learning and are influenced by classical conditioning. This is based on~     numerous studies indicating that conditioned contextual cues influence craving for alcohol~     consumption. As a result, there has been considerable interest in extinction-based treatments~     for AUDs (i.e., treatments that focus on extinguishing the associations between alcohol cues~     and motivation to drink), referred to as cue exposure treatment To date, extinction-based~     treatment for AUDs has resulted in disappointing outcomes in clinical trials and there is~     considerable interest in improving this form of treatment. One novel strategy is the use of~     pharmacological adjuncts to enhance extinction. Medications that maximize extinction may~     minimize subsequent reactions to alcohol cues and, in turn, subsequent clinical outcomes.~     This study is examining whether the medication d-cycloserine (DCS) can enhance extinction to~     alcohol cues. Recent basic research has revealed that DCS enhances extinction to fear cues~     and several lines of evidence suggest that DCS may also enhance extinction to alcohol cues.~     Therefore, DCS may serve as a useful pharmacological adjunct to extinction-based treatment~     for AUDs. Our primary aim is to examine whether, compared to placebo, DCS (50 mg) will~     enhance extinction to alcohol cues under controlled laboratory conditions in~     treatment-seeking individuals with alcohol use disorders. We hypothesize that DCS will~     generate greater extinction compared to placebo during the subsequent extinction session as~     measured by attenuated craving in response to alcohol cues. Furthermore, we hypothesize that~     DCS will generate greater extinction compared to placebo at follow-up assessments. This study~     is a proof-of-concept test of whether DCS can reduce reactions to alcohol cues under~     controlled laboratory conditions. It is a preliminary study using a subclinical number of~     extinction sessions and medication administrations to establish whether or not DCS improves~     extinction in the laboratory. If proof-of-concept is supported, it will suggest that a~     clinical trial is warranted. A clinical sample and clinical context are used to maximize the~     potential generalizability from this exploratory study.~   "
168329|NCT01362296|"~     This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and~     safety of GSK1120212 compared with docetaxel in the second line setting for subjects with~     locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS~     mutation who have failed one platinum-containing chemotherapy regimen. A small subset of~     NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the~     primary KRAS population, for exploratory purposes.~   "
168330|NCT01362283|"~     The purpose of this study is investigating the proportion of Cardiovascular disease risk~     factors of hypertensive patients.~   "
168331|NCT01362270|"~     BACKGROUND Many patients in the trauma intensive care unit (TICU) require mechanical~     ventilation and sedation or anxiolysis. Mechanical ventilation means that a machine is~     helping a patient breathe if he can't breathe on his own. Because of the mechanical~     ventilation, these patients also require some medication to help keep them calm. These are~     called sedatives or anxiolytics.~      The purpose of this study is to see if acupuncture can lower the amount of sedation and~     anxiolysis needed by a subject during mechanical ventilation in the TICU. Acupuncture is a~     medical procedure. Hair-thin sterile needles are inserted at specific points on the body.~      PROCEDURES Some subjects will get acupuncture and others will get 'fake' acupuncture. By~     using 'fake' acupuncture, no one other than the acupuncturists will know which group a~     subject is in. Subjects and the team do not get to pick which subject is in which group.~     Instead, the groups are picked randomly. Subjects will get real or fake acupuncture twice a~     day for five days.~      Standard of care - Both groups will receive the standard of care while in the study. They~     will be mechanically ventilated and given sedatives and analgesics based on the TICU~     protocol.~      Real acupuncture group - This group will receive real acupuncture with real needles. These~     are stainless steel, one time use, needles. This group will also receive ear tacks which~     are like little needles that can stay on the ear for a few days. The ear tacks will be~     covered with a bandage so no one can tell which group the subject is in.~      Sham acupuncture group - This group will receive sham needles. These needles retract into~     themselves much like a 'magic sword' rather than poking the skin. Subjects in this group will~     not get ear tacks. In order to hide the group the subject is in, a bandage will be used to~     cover part of the ear.~      HYPOTHESIS Real acupuncture will decrease subject's sedation requirements by 30% when~     compared to the sham acupuncture group.~   "
168332|NCT01362257|"~     This will be a two-period, open-label study conducted at a single site. Six healthy male~     subjects will participate in the study to ensure at least four fully evaluable subjects. Each~     subject will receive a single 1000 μg (microgram) oral dose containing 50 μCi (Micro Curie)~     of [14C]-GSK573719 and a 65 μg intravenous infusion containing 7.1 μCi of [14C]-GSK573719.~     Whilst subjects are in-house, urine and faecal samples will be collected for a minimum of 168~     hours (7 days) after dosing or for up to 240 hours (10 days) depending on the amounts of~     radioactivity still being excreted after Day 5. Faecal sample collection may continue at home~     for up to 14 days. Bile samples will be collected using Entero-Test string sampling of~     duodenal bile. Whole blood and plasma samples will be collected at various sample times after~     dosing to measure parent drug (plasma only) and total radiolabelled drug related material~     (blood and plasma). Urine and faeces aliquots will be taken to measure total radiolabelled~     drug-related material. Samples of urine, faeces and plasma will be transferred into a~     separate study to characterize and, where possible, quantify metabolites in these matrices.~   "
168333|NCT01362244|"~     A two-part, randomised, double-blind, placebo controlled, multi-centre study to investigate~     the use of mepolizumab (SB-240563) in reducing the need for surgery in subjects with severe~     bilateral nasal polyposis.~   "
168334|NCT01362231|"~     The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind,~     placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with~     Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.~      Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in~     subjects with IPF and is currently enrolling.~   "
168335|NCT01362218|"~     This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the~     cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril)~     as compared to the effect on LDL cholesterol of the reference products (simvastatin,~     ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized~     in order about 238 subjects to finish the study.~   "
168336|NCT01362205|"~     This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study of~     dexmedetomidine versus placebo, with lorazepam rescue, for the management of severe alcohol~     withdrawal syndrome (AWS) and alcohol withdrawal delirium (AWD) in critically ill adults.~      The investigators hypothesize that the integration of dexmedetomidine (Precedex®) with usual~     therapy for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal~     delirium/delirium tremens (AWD) in critically ill adult patients will reduce the time to~     resolution of AWS/AWD, increase the number of delirium-free and ventilator-free days in the~     first 28 days of hospitalization, reduce the length of ICU and hospital stays, and improve~     neurocognitive and quality of life scores on hospital discharge.~   "
168337|NCT01362192|"~     The purpose of this study is to evaluate the safety and effectiveness of a new laser for the~     removal of unsightly spider veins on the legs. The device used in this study is the Cutera~     Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064~     nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received~     510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological~     and vascular conditions, like spider veins.~   "
168338|NCT01362179|"~     This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized~     peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that~     the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated~     hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized~     PBSC donors.~   "
168339|NCT01362166|"~     The main purpose of this study is to detect the frequency response in the electric wave~     transmission through the channels inside human body. With the electric signals in different~     frequencies, analyzed by the digital signal processing technique, the adaptability of the~     channel for different frequencies may be revealed. With this study there will be a feasible~     connection between the physiological signals and the channel theory in Chinese medicine, and~     the basis of the physiological signals can be drew out for the description of the internal~     organs, the strong or weak, the truth or falsity.~      The Zu-San-Li is the open acupoint on foot-Yangming channel, the stomach channel. Qi, the~     main concept in TCM, will flow from the open acupoint to go into deep internal organs.~     Xian-Gu is another Yu acupoint on foot-Yangming channel. The inborn original Qi flows from~     the Yu acupoint infuse into blood vessels. So in this study the investigators will take these~     two acupoints for the acupuncture. Since the direction of the channel is from Zu-San-Li to~     Xian-Gu, the investigators pick Zu-San-Li as the input and Xian-Gu the output for the~     electrical signals.~      For this experiment, the investigators planned enrolling 30 male sub-healthy volunteers, aged~     in 20-35 years old, to finish the whole experiment procedures.~      After the acupuncture, the electric signals of different modes will be input from the~     subject's open acupoint (Zu-San-Li), and measure the frequency respond voltage from the~     output acupoint (Xian-Gu).~      Each subject must complete the acupuncture of Zu-San-Li and Xian-Gu, and be input 5 sets of~     the electric signals of different modes two times on the trial. The variety conditions of the~     wave form and electric voltage will be recorded and measured respectively.~      The investigators plan to obtain the data in six months, and complete the data analysis and~     sorting in two months.~   "
168340|NCT01362153|"~     This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous~     administered golimumab in patients with rheumatoid arthritis.~   "
168341|NCT01362140|"~     The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the~     incidence of red blood cell transfusions during the 24-week double-blind treatment period in~     anemic patients with low or intermediate-1 risk MDS.~   "
168342|NCT01362127|"~     The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a~     higher degree of complete histological response than neoadjuvant chemotherapy before surgery~     in patients undergoing treatment for cancer of the esophagus or cardia.~   "
168343|NCT01362114|"~     In this randomized, double blinded, Placebo-control Trial, the investigators planned to give~     Sihogayonggolmoryeo-tang extract or controlled medication on the Anxiety of Hwa-byung.~   "
168344|NCT01362101|"~     This study is ancillary. Participants will be recruited as part of a separate clinical trial~     on effects of two intensive behavioral training programs that evaluates feasibility and~     efficacy of a behavioral treatment that includes mindfulness techniques (MT) in comparison to~     traditional behavioral therapy (CBT) for smoking cessation. The investigators propose to~     compare the effect of MT to that of traditional CBT on a physiological marker of stress,~     salivary cortisol concentration, and physiological responses to smoking cues in tobacco~     smokers. The investigators will use electrophysiological reactivity to smoking cues in the~     form of audio recordings of personalized scripts describing the scenarios associated with the~     strongest urges to smoke that will provide a physiological validation to a behavioral~     intervention. The investigators will also explore correlations between these biological~     markers and self report of stress, craving and negative affect to supplement self report and~     behavioral outcome measures with biological and physiological markers to represent~     improvement attributed to the intervention.~   "
168345|NCT01362088|"~     In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous~     Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From~     there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate,~     the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are~     subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number,~     the microvascular flow index (MFI).~   "
168346|NCT01362075|"~     The purpose of this study is to determine the efficacy of local infiltration analgesia as~     compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The~     investigators hypothesize a reduced pain score and use of supplemental analgesic medication~     during the first three postoperative days using local infiltration analgesia.~   "
168347|NCT01362062|"~     This observational study will evaluate the safety, tolerability and efficacy of tocilizumab~     in participants with moderate to severe RA who have an inadequate response to current~     non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each participant~     during tocilizumab therapy and on follow-up for a total of 12 months.~   "
168348|NCT01362049|"~     The research objective is to determine which physical therapy (PT) treatment is the most~     efficacious for patients with lower back pain (LBP), who have been subgrouped based on~     certain clinical features. There is only limited evidence that supports any one PT treatment~     for patients with LBP since PT treatment outcomes for exercise protocols are equivocal, given~     the heterogeneous clinical features of patients with LBP. Thus, classification of patients~     with LBP into subgroups with shared clinical features has been identified as a research~     priority by several groups in order to prescribe the most efficacious PT treatment for each~     homogeneous subgroup. The investigators hypothesize that particular PT treatments are most~     efficacious when applied to patients with LBP, who present with particular clinical and~     neuromuscular features.~   "
168349|NCT01362036|"~     Phase 1, single-center, open-label, sequential cohort dose escalation study. This is a 3 + 3~     design study involving at least 3 subjects in ascending dose cohorts, with subjects~     participating up to 10 weeks.~      The overall study objectives are to evaluate the safety and tolerability of TXA127 in~     thrombocytopenic subjects with low or intermediate-1 risk MDS.~      Evaluation of the platelet response and the erythroid and granulocytic responses to TXA127~     will provide preliminary efficacy data.~   "
168350|NCT01362023|"~     Our hypothesis is that a regular systematic educational intervention in primary school~     improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate~     the effects of a 3-year school-based program of lifestyle improvement, including diet and~     physical activity, implemented by university students acting as health promoting agents~     (HPA) on the prevalence of obesity.~   "
168351|NCT01362010|"~     The purpose of this study is to evaluate the tolerability and safety and to determine whether~     FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.~   "
168352|NCT01361997|"~     The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior~     preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70%~     isopropyl alcohol.~   "
168507|NCT01359956|"~     This study evaluated two chemotherapy regimens with and without the addition of interferon in~     patients with advanced or recurrent melanoma.~   "
168729|NCT01357044|"~     this is a prospective randomized placebo-controlled double-blinded trial investigating the~     effect of plant extracts from Alpinia galanga and Punica granatum on human semen quality. The~     investigators hypothesize that these plant extracts will improve semen quality.~   "
168353|NCT01361984|"~     This is a PI-initiated study taking place only at UCLA, sponsored by Sunovion. The~     investigators plan to enroll about 20 subjects who are at least 40 years old and have Chronic~     Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the~     effectiveness of Brovana and Serevent in helping relieve COPD symptoms. Specifically, the~     investigators are looking at how much and for how long the two drugs can open up the small~     airways in the lungs. This will be done with breathing tests on all subjects, and with high~     resolution CT scans on subjects who agree to this optional part of the study. Half of~     subjects will take Brovana (arformoterol tartrate inhalation solution) for 2 weeks and then~     Serevent (salmeterol xinafoate inhalation powder) for 2 weeks; the other half will take~     Serevent the first two weeks and Brovana the second two weeks. All subjects will also take~     Spiriva (tiotropium) and will be provided with albuterol for immediate relief of symptoms.~     After a Screening Visit to determine eligibility, subjects will be randomly assigned to~     receive Brovana or Serevent for the first 2 weeks, complete Test Visit 1, then receive the~     other study drug for 2 weeks, and finally complete Test Visit 2. Visits will include~     questionnaires, review of health and medications, and breathing tests before and after taking~     the study drug. Subjects who agree to be in the sub-study will also undergo CT scans before~     and after taking the study drug at both test visits.~   "
168354|NCT01361971|"~     Obesity is an epidemic in Western society and is the biggest risk factor for insulin~     resistance and type 2 diabetes. The investigators have preliminary evidence showing that~     hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires~     confirmation in a larger population, and with this study the investigators will also test for~     mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress~     response proteins following changes in tissue oxygenation may contribute to these~     improvements. This study has the potential to yield new and important insights into the~     insulin resistance in obesity.~   "
168355|NCT01361958|"~     The aim of the present study was to evaluate the ability of several doses of NOMAC in~     combination with E2 to inhibit ovulation and to assess changes in the gonadotropin and~     ovarian hormone profiles, in comparison to a control cycle in healthy-volunteer premenopausal~     women.~      The study was also designed to check whether the combined administration of E2 and NOMAC at~     the dose of 2.5 mg daily induces any changes in the effects of the progestin compared to when~     it is given alone.~   "
168356|NCT01361945|"~     The purpose of this study is to find out what effects, administering infusions of AUY922 with~     hormonal therapy (letrozole) and oral targeted drug (lapatinib) will have on the patients~     with advanced breast cancer known as ER+ HER2 +.~   "
168357|NCT01361932|"~     This project will evaluate the effectiveness of 38 videos of discharge instructions for~     patients seen in, and discharged from, the emergency department (ED). The investigators will~     (1) assess how many ED patients chose view the website, and (2) interview patients who viewed~     a video, as well as those who didn't view a video (and therefore received standard care), to~     determine whether patients who viewed a video understood their diagnoses and discharge~     instructions better.~   "
168358|NCT01361919|"~     The goal of this study is to compare three methods of teaching medical and nursing students~     basic life saving skills. The standard method will teach students how to push on the chest~     and to analyze the heart rhythm using a regular monitor. The newer approach will teach the~     same skills but use a special heart monitor that provides both visual and verbal reminders.~     The third approach will combine both the standard and newer approaches to teaching. Our study~     would like to find out the better way to teach these skills and to create a standard way to~     grade how well students perform. This study will measure how deep and how fast the students~     push on the manikin's chest in a certain amount of time. Other goals include measuring how~     well the students use the heart monitor to deliver shocks and analyze the heart rhythm, how~     many breaths per minute they give, how long their hands are off the manikin and how well they~     think they performed overall.~   "
168359|NCT01361906|"~     The purpose of this study is to determine whether sensomotoric training can reduce~     neck/scapular pain in people with visual disability.~   "
168360|NCT01361893|"~     The overall purpose of this investigation is to better understand factors contributing to the~     high incidence of prone sleep positioning in African-American infants. In addition, the~     investigators are interested in investigating other races and ethinicities to understand~     their beliefs and perceptions and determine differences socioeconomically and socioculturally~     within and between groups. The investigators will address the following specific aims:~      (-) To compare knowledge, attitudes, and practices regarding infant sleep position in parents~     of higher and lower SES.~      (-) To identify risk factors for non-use of recommended supine sleep position in families~     with higher and lower SES (-) to develop a phenomenologic understanding of the decisions made~     by parents of higher SES and lower SES who do nt use recommended supine sleep position, using~     qualitative techniques.~   "
168361|NCT01361880|"~     The overall purpose of this randomized trial is to develop and evaluate a systematic approach~     to improve African-American parental behaviors specifically with regards to the infant sleep~     environment. African-American parents of newborn, healthy term infants will be randomized to~     receive either a standard message to avoid bedsharing, eliminate use of soft bedding and soft~     sleep surfaces, and to place infants in the supine position for sleep to reduce the risk of~     SIDS or an enhanced message to avoid these behaviors to both reduce the risk of SIDS and to~     prevent infant suffocation.~   "
168362|NCT01361867|"~     The aim of the study is to assess the ability of healthy subjects to generate a motor~     adaptation in response to a mechanical perturbation generated by a robotic system for~     treadmill-based gait training (Lokomat by Hocoma AG, a device that received 510K FDA~     clearance).~   "
168363|NCT01361854|"~     Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected~     of sleep-disordered breathing.~      First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with~     the portable monitoring.~      Second one: hook-up is performed home, around 7 PM, and the patient has not to move after~     hook-up.~   "
168508|NCT01359943|"~     The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous~     (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo,~     followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite~     treatment with Methotrexate.~   "
168364|NCT01361841|"~     Intraocular pressure (IOP) is considered to be the main risk factor for progression of~     glaucoma and therefore the main target of therapy. Pharmacologic treatment of glaucoma has~     changed considerably during the last decades due to the introduction of prostaglandin~     analogues. Three of these are commonly used in North America: latanoprost (Latanoprost T,~     Pfizer), Travoprost (Travatan TM, Alcon) and bimatoprost (Lumigan TM, Allergan).~      There have been several studies to evaluate their effectiveness. The three seem to be~     equivalent, according to the only study that has compared the molecules. Latanoprost is~     employed initially, due to its paucity of side effects when compared to the other two~     analogues. However, if it is not effective, several studies ahve shown that a result is~     possible using either travoprost or bimatoprost. No study has been conducted to date~     systematically comparing the three molecules in cases of resistance to latanoprost. In~     actuality, the investigators patients will receive treatment identical to current practice~     with the exception of the group continuing with latanoprost. Several studies confirm the~     benefit of changing prostaglandin analogues if the first has not signficantly decreased the~     IOP (Palmberg et al. 2004). Each prostaglandin has unique properties which may cause the~     mechanism of action to vary slightly among patients. (cf. Pharmacological Aspects)~      The goal of the study is thus to evaluate the efficaciousness of latanoprost, bimatoprost and~     travoprost in their IOP-lowering capacity in patients who do not initially respond to~     latanoprost.~   "
168365|NCT01361828|"~     The purpose of this study is to investigate the possible affection of optic nerve and retinal~     functions following intravitreal bevacizumab injection in human eyes.~   "
168366|NCT01361815|"~     The purpose of the study is to explore the Tolerability and Safety of the H-Coil deep~     Transcranial Magnetic Stimulation (TMS) in combination with Serotonin Selective Reuptake~     Inhibitor (SSRI) for Subjects with Major Depression Disorder (MDD) who Complete/ Discontinued~     the Deep TMS Multicenter study for Subjects with Major Depression Disorder (MDD) (Protocol#~     CTP-0001-00).~   "
168367|NCT01361802|"~     The development of a new Ambroxol spray formulation for the treatment of sore throat pain~     associated with acute pharyngitis requires an initial phase II study to be conducted in order~     to select the most appropriate dose for pain relief.~   "
168368|NCT01361789|"~     Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID~     or COX-2 selective inhibitor gives better pain relief than either of the drugs used~     separately. The investigators group has also shown that adding dexamethasone on top of a~     regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest~     after ambulatory breast cancer surgery.~      The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The~     investigators want to evaluate whether a selective COX-2 selective inhibitor or a~     glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can~     provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL~     surgery.~   "
168369|NCT01361776|"~     Antibody titers after tick-borne encephalitis (TBE) vaccination are less in elderly and~     vaccination breakthroughs are more common in this age group. This has prompted Swedish~     authorities to recommend an additional dose in the initial vaccination schedule (= 0+30+90~     days instead of the usually recommended 0+30 days. The investigators intend to evaluate this~     regime.~   "
168370|NCT01361763|"~     This study is a Phase II, randomized, crossover trial designed to compare one fixed dose of~     dabigatran with open-label use of ASA in patients affected by CADASIL; the study is a safety~     trial, and the primary objective is to assess that dabigatran is not less safe than ASA in~     subjects with CADASIL.~   "
168371|NCT01361750|"~     This study is to investigate the effects of narrowed gastric tube on postoperative~     nutritional status and the quality of life in esophageal cancer patients treated with~     Ivor-Lewis esopagectomy in a 12-month follow-up period.~   "
168372|NCT01361737|"~     Could possible markers in serum obtained in the first trimester predict the human-pregnancy~     specific disorder pre-eclampsia?~   "
168373|NCT01361724|"~     Problems with balance and walking that affect mobility are an inevitable cause of decreased~     quality of life in older people with chronic neurologic conditions such as Parkinson's~     disease (PD). Although there is evidence that exercise can improve mobility in the elderly,~     the investigators don't know: 1) What is the best mode of exercise intervention delivery~     (i.e. individual therapy in a clinic, home exercise program, or a group class)? and 2) how do~     other problems common in people with PD and/or the elderly affect outcomes? Although most~     physical therapy is carried out individually, a group or home program would be most~     cost-effective so the investigators need to know if they are just as effective. Since most~     older people with chronic neurologic diseases also have other problems affecting mental~     function, muscles and joints and/or pain, it is important to understand how these other~     problem affect the success of their therapy. The purpose of this study is to investigate how~     PT intervention should be delivered to patients with chronic neurologic disease who also have~     other problems. The investigators will using elderly people with PD who have one or more~     co-morbidities associated with PD and/or aging. Sixty people PD and co-morbidities will be~     randomized into 1of 3 groups; home program, individual PT or group exercise class. Each of~     the 3 groups will be led by the same PT providing a novel sensory-motor agility program~     developed by our laboratory. All groups will perform the same type of exercises 3 X/week for~     4 weeks. Improvement in the Physical Performance Test of disability will be used to determine~     the success of therapy. To determine how and why mobility was improved by therapy, changes in~     gait, balance, and quality of life will be measured. Gait and balance will be measured with~     new, wearable motion sensors (iPOD size) while standing up from a chair, walking, turning~     around and sitting back down. The findings from this study will help guide rehabilitation~     treatment for complex , chronic problems affecting mobility in older people.~   "
168374|NCT01361711|"~     This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab~     together works in treating patients with previously untreated chronic lymphocytic leukemia~     (CLL). Monoclonal antibodies, such as alemtuzumab and ofatumumab, can block cancer growth in~     different ways. Some block the ability of cancer to grow and spread. Others find cancer cells~     and help kill them or carry cancer killing substances to them. Giving alemtuzumab together~     with ofatumumab may kill more cancer cells~   "
168375|NCT01361698|"~     The aim of this trial is to evaluate the effectiveness of the Illness Management and Recovery~     program for people diagnosed with schizophrenia or bipolar disorder in according to their~     level of functioning.~   "
168376|NCT01361685|"~     Lead survivability will be summarized.~   "
168377|NCT01361672|"~     Lead survivability will be summarized.~   "
168391|NCT01361490|"~     Obesity may have implications on the individual's participation in working life through~     different mechanisms such as comorbidity and loss of functional level. The investigators also~     know that when exiting the working force, it is difficult to get back later. As~     rehabilitation back to working life is often not a very focused aim with weight loss~     treatment, this study sets this as a primary aim by involvement in a 4 week stay at a~     rehabilitation clinic followed by 48 weeks work practice programme at one of three different~     companies.~   "
168378|NCT01361659|"~     There is an increasing number of patients with a coronary anatomy that does not allow~     additional revascularization procedures, while the patients suffer from angina pectoris at~     rest or at minimal exercise levels despite optimised medical therapy. There is a lack of~     therapeutic options for this group of so called no-option patients. Goal of the project is~     to implement the shockwave therapy for no-option coronary artery disease patients and to~     evaluate its potential benefit on regional myocardial perfusion, on regional myocardial~     function and on the potential improvement in symptoms and quality of life.~   "
168379|NCT01361646|"~     This will be a dose block-randomized, double-blind, active and placebo controlled, single and~     multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic /~     pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and~     laboratory tests will be conducted for safety/tolerability evaluation and serial blood~     samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be~     conducted at specified time points.~   "
168380|NCT01361633|"~     The goal of this study is to determine whether a study medication (d-cycloserine) improves~     the ability of older adults to perform on tests of neuropsychological functioning. Tests of~     neuropsychological functioning assess attention, memory, and executive functioning skills~     (for example, problem-solving, planning and organizing skills). It was hypothesized that~     participants who received study medication would perform better on neuropsychological tests~     than would participants who received the sugar pill.~   "
168381|NCT01361620|"~     The study seeks to identify genomic markers associated with aspirin resistance.~   "
168382|NCT01361607|"~     This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols~     (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled~     persistent chronic pain in participants with advanced cancer.~      Eligible participants were not required to stop any of their current treatments or~     medications.~   "
168383|NCT01361594|"~     High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are~     associated with increased risk of hospital complications. Blood sugar control with~     intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac~     bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before~     or after surgery). It is not clear what the best insulin regimen is or what is the best blood~     sugar target in these patients. Accordingly, this research study aims to determine optimal~     blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will~     be divided in two groups. The intensive insulin group will be maintained at blood glucose~     between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180~     mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are~     approved for use in the treatment of patients with diabetes by the FDA (Food and Drug~     Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery~     will be recruited in this study. Patients will be recruited at Emory University Hospital,~     Emory Midtown Hospital and Grady Memorial Hospital.~   "
168384|NCT01361581|"~     Citrate anticoagulation is associated with metabolic side effects which are linked to a~     portion of citrate reaching systemic circulation. Data on significance of systemic gain of~     citrate and its relationship to method configuration are missing. Patient might also receive~     certain dose of lactate as a buffer and a dose of glucose if acid-citrate-dextrose solution~     is used. The authors test variable methods of indirect estimate of systemic dose of citrate~     which would allow to quantify the metabolic input without mostly unavailable measurements of~     citrate levels.~   "
168385|NCT01361568|"~     The primary purpose of this study is to determine if CR845 is effective in treating the pain~     associated with a laparoscopic hysterectomy.~   "
168386|NCT01361555|"~     The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836~     in patients with depression.~   "
168387|NCT01361542|"~     Ankylosing Spondylitis (AS) is a chronic painful progressive inflammatory arthritis of~     unknown etiology primarily affecting the spine and sacroiliac joints. In addition to~     formation of new bone leading to syndesmophytes and ankylosis; osteoporosis is also a~     prominent feature in AS-thus showing the paradox of new bone formation at abnormal sites~     coexisting with reduced bone mass & increased fracture risk. Osteoporosis is a common~     complication of AS, with an incidence between 18.7% and 62%. TNF alpha has a central role in~     disturbing this balance in bone metabolism--resulting in accelerated alveolar bone loss and~     decreased strength- i.e. osteoporosis. The investigators hypothesis that anti TNF therapy is~     effective in active AS resistant to conventional therapy and helps in improving the bone~     density and over all bone health.~   "
168388|NCT01361529|"~     The purpose of this study is to determine the tolerance and maximum tolerated dose (MTD) for~     FLP Injection with multiple dose in tumor patients.~   "
168389|NCT01361516|"~     The aim of the study is to compare the impact intravenous sedation versus general anesthesia~     on the efficacy of stone fragmentation in extracorporeal shock wave lithotripsy treatment.~   "
168390|NCT01361503|"~     The primary objective of this study is to conduct magnetic resonance spectroscopic (MRS) and~     imaging (MRI) scans to assess the structural and neurochemical profile of the brain in 20~     children and adolescents, 6-17 years old with Autism Spectrum Disorder (ASD). For comparison,~     MRS and MRI will also be obtained from 10 healthy control subjects, matched to the 20~     subjects with ASD in age, sex, dexterity, and IQ. All eligible subjects will be administered~     a detailed assessment battery consisting of cognitive assessments (neuropsychological battery~     including subsets of the DANVA2 and the CANTAB) and measures of psychosocial functioning~     (SAICA and M-FES). The study includes 1-3 visits for the screening period at Massachusetts~     General Hospital (approximately 4 hours of assessments) and one scanning visit at McLean~     Hospital (approximately 1.5 hours).~      The investigators hypothesize that youth with ASD versus controls will exhibit increased~     glutamate concentrations, reflecting glutamatergic overactivity, and increased Cho~     concentrations, suggesting neuronal abnormality. Furthermore, the investigators hypothesize~     that compared to neurotypical controls, the structural integrity of white mater tracts will~     be disrupted in ASD.~   "
168461|NCT01360567|"~     The aim of the study is to examine whether the extract of green tea is effective on type 2~     diabetes and hyperlipidemia.~   "
168509|NCT01359930|"~     The study is to primarily measure safety and interactions between oral doses of~     Naltrexone/Bupropion and i.v. Methamphetamine.~   "
168392|NCT01361477|"~     As general surgical intensive care units of the biggest tertiary referral university of~     Thailand with more than 1,000 admissions/year. Recently, more complicated perioperative care~     surgical patients were accepted with high complications and resource utilization. Good data~     registration was needed to provide information for quality improvement and resource~     allocation. This prospective observational (crosssectional) study was designed to register~     patient > 18 years who will be admitted to these ICUs for 1 years to explore the adequacy of~     these ICUs services, resource utilization (ICU length of stay and ventilator day), ICU~     complications and adverse outcome /ICU readmission within 72 hours after discharging from~     ICU.~   "
168393|NCT01361464|"~     This phase II trial is studying how well tipifarnib works in treating older patients with~     acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~   "
168394|NCT01361451|"~     There are 24,000 admissions each year to Intensive Care Units (ICU) in the United Kingdom due~     to pneumonia, asthma and a common condition called chronic obstructive pulmonary disease~     (COPD), with rates of death of 10%, 40% and 50%, respectively. These conditions account for~     10% of all ICU admissions. It is therefore important to find out if it would be possible to~     detect deteriorations in patients with breathing problems early, in order to increase~     appropriately their level of care.~      Clinical early warning scores (EWS) are used in many hospitals to detect patients whose~     medical condition is getting worse, and who are likely to need admission to intensive care or~     high dependency care units. EWS are usually calculated from several measurements taken from~     the patient, such as blood pressure, temperature and heart rate. However, they are often~     inaccurate as they need to be calculated manually by nursing staff from a number of~     measurements taken from a variety of different devices. Furthermore, even when accurately~     calculated, it is not clear how helpful EWS are in predicting whether or not patients will~     deteriorate.~      Neural respiratory drive (NRD) is an objective indicator of breathlessness, and can be~     derived from the amount of electrical activity occurring in certain muscles used in~     breathing. The Myotrace system measures this electrical activity, as well as measurements~     such as rate of breathing and heart rate. It then analyses these measurements together to~     help identify patients at risk of deterioration.~      This study will use Myotrace to monitor patients with severe breathing difficulties due to an~     acute worsening of chronic obstructive pulmonary disease, for early identification of failure~     to respond to medical treatment.~      Patients will be recruited at St. Thomas' Hospital.~      This research is funded by the Guy's and St. Thomas' Charity.~   "
168395|NCT01361438|"~     This study will enroll adult de novo Ph+ acute lymphoblastic leukemia (ALL) patients (≥18~     years, ≤60 years). Induction treatment will consist of 12 weeks of Dasatinib oral~     administration (140 mg QD). Patients will initiate treatment with steroids 7 days prior to~     starting Dasatinib and will continue up to day 31. Patients will continue treatment with~     Dasatinib up to day 84, except for disease progression, intolerable toxicity, or withdrawal~     from study.~   "
168396|NCT01361425|"~     Introduction: Hypertensive emergency in pregnant women with pre-eclampsia should be treated~     for preventing stroke and placental abruption. However, the benefit of antihypertensive~     medication maintenance remains unclear, mainly due to the potential risk of fetal growth~     restriction.~   "
168397|NCT01361412|"~     The aim of the study is to identify changes in potential biomarkers after peptide~     immunotherapy for that may subsequently be developed as biomarkers that correlate with~     clinical efficacy.~   "
168398|NCT01361399|"~     The purpose of this study is to investigate the analgesic efficacy of a single dose of a~     fixed combination of 500 mg Aspirin (Acetylsalicylic Acid) and 4 mg Lidocaine in adult~     patients with sore throat associated with a common cold in comparison to a single treatment~     with 500 mg Aspirin or 4 mg Lidocaine alone as well a Placebo (treatment without any active~     ingredient). The combination of Aspirin and Lidocaine in a single lozenge is expected to~     provide relief from sore throat pain by sequential action. A very fast inset of action will~     be achieved by the locally acting Lidocaine and a long duration of action will be achieved by~     the systemically acting Aspirin.~   "
168399|NCT01361386|"~     The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years~     following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e.~     STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality~     of life of these AMPs in a 'real-life' setting.~   "
168400|NCT01361373|"~     Background:~      Cerebral palsy (CP) is the main cause of childhood immobility and is defined as a non~     progressive injury to the developing central nervous system in children younger than 3 years,~     resulting in neurological and musculoskeletal abnormalities. The main pathophysiological~     causes are encephalopathy of prematurity (periventricular leukomalacia) hypoxic ischemic~     encephalopathy. Infections, infracts and migration defects are other less common causes of~     CP. The brain injury leads to functional motor impairment impacting on daily activities~     commonly manifests as a movement disorder: pyramidal, leading to spasticity and~     extra-pyramidal leading to dystonia and chorea. In most cases extensive brain injury causes a~     mixed movement disorder. Dystonia is defined as involuntary muscle contractions causing~     twisting and abnormal postures. While the neurological underpinnings of CP remain unknown, a~     link between low dopamine and increased acetylcholine release has recently been reported in~     dystonia. Dopamine is considered the first line of treatment in children with dystonia and CP~     followed by anticholiergic treatment with trihexphenidyl. The recommendation of dopaminergic~     treatment is based on need to rule out dopamine-responsive-dystonia, a rare genetic disorder,~     and on single case study reporting improvement in CP. A double blind study support or refute~     the use of dopamine treatment for dystonic CP was never reported. Working hypothesis and~      Aims:~      In children with CP due to a clear underlying pathology, dopamine treatment will not improve~     daily function. Methods: the investigators will perform a double blinded randomized~     controlled crossover study. 50 children ages 4-18 years with a clear pathophysiological cause~     for CP will be enrolled. Each child will receive dopamine and placebo treatment for 2 weeks~     with a 2 week washout interval. Participants will be randomized into 2 groups; one will~     receive placebo followed by dopamine and the other vice versa. The primary outcome measure,~     goal-attainment-scale, and secondary outcome functional measures (such as box and blocks, 9~     hole pegs, pronation/ supination, finger sequencing) will be assessed at the beginning and~     end of each treatment as well as parent questionnaires regarding satisfaction and side~     effects.~      Expected results:~      No functional improvement with dopamine treatment compared to placebo.~      Importance:~      supplying sufficient data to support or refute the use of dopamine treatment for dystonic CP.~      Probable implications to Medicine:~      this may lead to a change in medical treatment guidelines for children with CP.~   "
168401|NCT01361360|"~     In the US, every year approximately 30,000 infants are born very prematurely, with birth~     weight less than 1000 grams. These infants usually require ventilators to help them breath~     normally during the first few weeks of life. Although the ventilator is lifesaving, it can~     also injure the very fragile lungs of these infants. Thus, a ventilation strategy, called~     permissive hypercapnia (high carbon dioxide), is widely used to prevent lung injury.~     Importantly, there is new research showing that high carbon dioxide may cause brain injury.~     In our proposed research, we will use magnetic resonance imaging methods to evaluate the~     brain in 40 very premature infants at term−equivalent age (Half of them had permissive~     hypercapnia ventilation, the other half did not) to see if permissive hypercapnia has adverse~     effect on brain development.~   "
168402|NCT01361347|"~     The purpose of this study is to study the number of Participants with Adverse Events as a~     Measure of Safety and Tolerability.~   "
168567|NCT01359163|"~     A pivotal study to determine bioequivalence between a the current marketed formulation of~     Femulen tablets and reformulated Femulen tablets in healthy female subjects.~   "
168403|NCT01361334|"~     Long term disease-free survival (DFS) of patients with acute myeloid leukemia (AML) is still~     poor. Recently, so-called targeted therapy for cancer has been introduced to the treatment~     of patients with AML. This phase II clinical trial will explore the efficacy, safety, and~     pharmacodynamics of the tyrosine kinase inhibitor pazopanib in patients with relapsed or~     refractory AML or patients with AML who are not eligible for intensive treatment. Biomarker~     studies will be included to study whether the targets are indeed inhibited and whether this~     leads to decreased BM angiogenesis. Toxicity assessments will be included, and the~     antileukemic effectiveness will be studied.~   "
168404|NCT01361321|"~     Edentulism refers to a state of full or partial lack of teeth. This situation may interfere~     with essential functions such as mastication, speech and even appearance.~      Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to~     restore edentulus alveolar ridges by providing support and anchorage for removable or fixed~     dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of~     sufficient bone tissue volume to support the dental implant.A situation like this may~     originate from a variety of reasons such as residual bone atrophy, prior alveolar bone~     destruction due to periodontal disease and even a traumatic tooth extraction. In such cases,~     a routine alveolar bone augmentation is done to enable a dental implant installation at this~     site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone~     ridges. It relies on an inert membrane covering a bone substitute placed over the bony site~     requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by~     the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to~     the bony defect area.~      The investigators research is a aimed to preform a follow up after patients who already went~     through a GBR procedure and before inserting a dental implant. Patients answering the~     inclusion but not the exclusion criteria will go through an alveolar computerized tomography~     (C.T) done routinely before inserting dental implants.At the day of Dental implantation -~     residual bone left from the site of implantation (after preparing the site with a trephine~     bur) will be taken to a histological analysis. The results from the C.T and the histological~     examination will be analyzed for bone quantity (volume) and quality and will allow a~     comparison of bone characteristics obtained by using different routinely used bone~     substitutes.~   "
168405|NCT01361308|"~     The purpose of this study is to assess the safety & efficacy of Brisdelle (paroxetine~     mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with~     menopause.~   "
168406|NCT01361295|"~     Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state,~     which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The~     induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a~     non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter~     has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be~     expected that these procedures induce a lower level of procoagulation.~      Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients~     undergoing cooled-tip catheter ablation of AF. In this study there will be used to different~     catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter~     is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis~     and CE may be increased.~      The goal of this study is to determine the effect of two different ablation catheters on the~     induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF~     undergoing PVI.~      Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show~     a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF~     undergoing PVI with the cooled-tip catheter.~   "
168407|NCT01361282|"~     Many patients with endothelial dysfunction also present with cataracts. It is therefore~     common practice to perform cataract extraction and intraocular lens (IOL) implantation during~     the same operation and immediately prior to Descemet's Stripping Automated Endothelial~     Keratoplasty (DSAEK), in order to minimize trips to the operating room and the associated~     risks of ocular surgery. However, the unique posterior corneal anatomy of the DSAEK recipient~     makes it difficult to predict pre-operatively the proper power of IOL to place, and some~     patients end up with a mismatched lens that requires spectacle correction. The current gold~     standard for IOL power calculation (A-Scan optical biometry) takes measurements of the~     anterior surface of the cornea and makes assumptions about the posterior surface that are~     violated by the unique hourglass shape of the donor DSAEK graft. New optical coherence~     tomography (OCT) technology provides us with the ability to measure curvature in both the~     anterior and posterior aspects of the cornea in order to generate an IOL calculation that has~     the potential to give more accurate results for our DSAEK patients.~      The investigators will be using the Optovue to perform corneal power analysis on patients who~     have already received DSAEK and cataract surgery, in order to compare the post-op Optovue~     power calculations to the pre-operative power calculations provided by the A-Scan. If the OCT~     is shown to provide accurate IOL power calculations, then some patients might be better~     served by a two-stage procedure where DSAEK is performed and then followed six months later~     by cataract surgery using the OCT to calculate IOL power.~   "
168408|NCT01361269|"~     Few efficient drugs for malaria treatment are available so far. Due to increased exposure of~     these drugs and due to the high risk of development of drug resistant strains of Plasmodium~     falciparum, new drug combinations have to be actively investigated. The investigators will~     test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment~     in acute uncomplicated malaria in children aged 3-10 years.~   "
168409|NCT01361256|"~     This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in~     patients with bilateral moderate to profound central vision impairment due to end-stage~     age-related macular degeneration.~   "
168410|NCT01361243|"~     The purpose of this study is to evaluate the efficacy of a parent intervention (NOURISH+)~     aimed at reducing the problem of overweight and obesity in children.~   "
168411|NCT01361230|"~     The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial~     comparing sedation management using a protocol based on responsiveness with standard sedation~     management. The hypothesis is that responsiveness will improve a range of patient-based and~     economic outcomes, including the duration of mechanical ventilation and duration of coma in~     the ICU. The purpose of the pilot study is to gather information for designing a full study~     that might show the validity of the outcome hypothesis.~   "
168462|NCT01360554|"~     This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the~     efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients~     with advanced non-small cell lung cancer, previously treated with at least one prior regimen.~     Analyses of primary objective (Progression Free Survival) will be done in two co-primary~     populations as defined in the protocol.~   "
168412|NCT01361217|"~     Inhibitory drug-drug interactions (DDIs) are a considerable concern as inhibition of drug's~     clearance can lead to increased plasma concentrations and subsequent adverse events and~     toxicities. Fluoxetine (Prozac®) is a widely prescribed antidepressant, but is also a potent~     inhibitor of cytochrome P450 (CYP) enzymes. Fluoxetine was chosen as the model inhibitor for~     this study because it is a clinically important inhibitor of multiple CYP enzymes with~     varying potencies for each isoform. From in vitro data, fluoxetine is predicted to be a~     moderate inhibitor of CYP2D6, but a strong inhibitor of CYP2C19 and CYP3A4. However, in vivo~     fluoxetine causes a potent interaction with CYP2D6 and a weak-to-no interaction with CYP3A4.~     The magnitude of the in vivo interaction of fluoxetine with CYP2C19 is not known. This in~     vitro-to-in vivo discrepancy is of concern for two reasons: 1) In clinical drug development,~     in vivo drug-drug interactions are tested only when in vitro experiments predict a risk for~     in vivo DDIs and 2) Because in vivo DDI's are tested using a rank order approach of going~     from the most potent in vitro interaction to the least potent until no interaction in vivo is~     observed. In this study the interaction between fluoxetine and CYP3A4, CYP2C19 and CYP2D6~     will be quantified simultaneously and the quantitative in vitro-to-in vivo predictions~     tested. Fluoxetine will be orally administered daily for 14 days and CYP1A2, CYP3A4, CYP2C19~     and CYP2D6 activity will be tested in the end of fluoxetine dosing using a cocktail of CYP~     probes including caffeine, midazolam, omeprazole and dextromethorphan. Lovastatin will be~     administered on a separate day and used as a second CYP3A4 probe to test whether CYP3A4~     inhibition by fluoxetine depends on the contribution of intestinal CYP3A4 to the probe~     clearance. Plasma and urine samples will be collected for 12 and 24 hrs, respectively, during~     the control sessions (before fluoxetine administration) and for 24 hrs during the treatment~     sessions (fluoxetine multiple dose). The concentrations of each of the probe drugs and their~     metabolites (when applicable) as well as fluoxetine and its metabolites will be measured in~     the collected samples and pharmacokinetic analysis will be performed. The primary outcome~     measures for CYP inhibition will be the increase in the area under plasma concentrations time~     curve (AUC) of each of the probes.The null hypothesis of this study is that the area under~     plasma concentrations time curves (AUCs) of caffeine, dextromethorphan, omeprazole, midazolam~     or lovastatin are the same between the control session and the fluoxetine session. Because~     lovastatin has the greatest variability in its baseline pharmacokinetics the study was~     powered based on the specific null hypothesis for lovastatin. The alternative hypothesis is~     that fluoxetine decreases the clearance of the probe drugs resulting in a significant~     increase in the AUCs between the control and study sessions.~   "
168413|NCT01361204|"~     Long-term practices in a hospital setting and community pharmacy might induce chronic stress~     in students. Alterations of salivary amylase activity will be measured in students during~     pharmacy practices as a marker of stress. Theanine is reported to have anti-stress effect on~     experimental animals under chronic stress and on humans under short-term stress. The purpose~     of this study is to measure stress symptoms in students during long-term pharmacy practices~     and to evaluate the efficacy of theanine in suppressing chronic stress, by measuring the~     salivary amylase activity.~   "
168414|NCT01361191|"~     The aim of the study is to evaluate the event free survival at three years in patients with~     diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction~     therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage~     treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET~     after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP~     without transplant.~   "
168415|NCT01361178|"~     Immunosuppressive therapies have led to remarkable improvements in survival in lung~     transplantation (LT) patients. However, one important adverse effect of these therapies has~     been the increasing emergence of hypogammaglobulinemia (HGG) which has been previously seen~     mostly in patients with primary immunodeficiency (PID).~      The goal of treatment of HGG in PID has been to maintain the trough IgG level above 500 mg/dl~     which might provide better protection against infections than do lower IgG serum~     concentrations. Although IgG therapy is of substantial benefit, the doses and trough levels~     of IgG that are optimal are not yet clearly established. The impact of high versus low IgG~     dosing on the frequency and severity of infections and rejection has not been studied before~     in LT patients with HGG. The specific aims for this study are to compare the incidence of~     infections in lung transplant recipients receiving higher versus lower dose of SQ IgG and to~     compare the incidence of infections in lung transplant recipients with mild~     hypogammaglobulinemia versus normal IgG levels. This study will be a single center study of~     all lung transplant recipients, age 18 years or older, at the University of Pittsburgh~     Medical Center (UPMC), with a randomized treatment arm and an observational arm.~      The hypotheses for the research study are:~        -  Therapy with IV or SQ IgG is of substantial benefit in reducing the number of infections~          in lung transplant recipients with severe hypogammaglobulinemia (IgG < 500)~        -  A higher dose of SQ IgG, with subsequent higher trough IgG levels, may have a higher~          impact on the frequency and severity of infections and rejection episodes, compared to a~          lower dose of SQ IgG, with subsequent lower IgG trough levels~        -  Lung transplant recipients with mild hypogammaglobulinemia ( IgG= 500-750) have a higher~          incidence of infections compared to patients with normal IgG levels~   "
168416|NCT01361165|"~     We plan to analyze the data to meet the primary objective of the study:~      To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA,~     during and following treatment with tenofovir DF-containing antiretroviral therapy in~     HIV-infected children.~      In addition, we plan to analyze the data to meet 2 secondary objectives of the study:~        1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid~          hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked~          N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific~          alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir~          DF-containing antiretroviral therapy.~        2. To study immunologic, virologic and clinical effects of tenofovir DF administered to~          HIV-infected children in combination with other antiretroviral therapies.~   "
168417|NCT01361152|"~     The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of~     prospective total knee arthroplasties performed in patients younger than fifty years of age~     with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to~     compare~        1. functional scores~        2. rates of radiographic failure~        3. revision rates~        4. survivorship~   "
168418|NCT01361139|"~     This is a study that seeks to characterize data obtained from patients with a variety of lung~     diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound~     instrument in the doppler mode (not the imaging mode used in examination of pregnant women~     for instance) is placed on the chest wall and the unique software the investigators have~     developed analyzes the signal reflected back from within the lung. On the basis of pilot~     studies performed previously the investigators expect to receive different signals from~     different diseases. The investigators seek to further characterize these signals to enable~     accurate diagnosis of different lung diseases using our technology.~   "
168419|NCT01361126|"~     This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX~     Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in~     subjects who have previously received factor replacement therapy for hemophilia B. The study~     consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5~     month treatment period. Subjects will receive weekly routine prophylactic therapy and~     on-demand treatment for bleeding episodes. In addition, subjects who are not on routine~     factor replacement therapy prior to the study will receive only on-demand treatment for~     bleeding episodes.~   "
168420|NCT01361113|"~     This study will be a single arm phase II clinical trial of 8 weeks of daily, oral~     neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically~     confirmed localized renal cell carcinoma (RCC).~   "
168463|NCT01360541|"~     Radiofrequency ablation versus endoscopic surveillance in the management of low grade~     dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.~   "
168464|NCT01360528|"~     Therefore preterm infants must need folic acid replacement than term babies.~   "
168421|NCT01361100|"~     This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study~     includes 2 steps. The first one aims to validate the algorithm defined at the time when the~     test was developed in patients with different tumour stages. Patients will be enrolled before~     any treatment. They will immediately undergo the test. No follow-up will be realized. In~     total, 100 patients will be included in this first step. The estimated period of inclusion is~     6 months.~      If the algorithm is validated, the second step of the study will start. The purpose is to~     determine the characteristics of the test. Enrollment will concern smokers and alcohol~     drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract.~     Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum~     of one year. In total, 385 patients will be enrolled in this step during an estimated period~     of 18 months.~   "
168422|NCT01361087|"~     Transforming Growth Factor Beta (TGF-β) is a protein that controls proliferation, cellular~     differentiation, and other functions in most cells. TGF-β levels play a major role in the~     pathogenesis of Marfan syndrome, a disease characterized by disproportionate height, long~     extremities, lens dislocation in the eyes and heart complications such as mitral valve~     prolapse and aortic enlargement increasing the likelihood of aortic dissection. While the~     underlying defect in Marfan syndrome is faulty synthesis of the glycoprotein fibrillin I,~     normally an important component of elastic fibers it has been shown that the Marfan syndrome~     phenotype can be relieved by addition of a TGF-β antagonist in affected mice.~   "
168423|NCT01361074|"~     The aim of this study is to explore the differential efficacy of in vivo exposure versus~     augmented reality exposure in the treatment of specific phobia (small animals).~      The hypothesis is: There will not be significant statistical differences in the efficacy of~     in vivo exposure therapy versus augmented reality exposure in the treatment of specific~     phobia (small animals).~   "
168424|NCT01361061|"~     Hepatocellular carcinoma (HCC) is one of the tumors with a rising incidence worldwide. The~     aim of this trial is to improve the detection of early HCC nodules in the liver. At the~     moment screening for HCC in patients with liver cirrhosis is performed by ultrasound and~     measurement of alpha- fetoprotein (AFP). In this trail the tumor markers AFP- L3 (a~     subfraction of AFP) and Des-y- carboxyprothromib (DCP) are measured in addition in order to~     receive information about the course of these markers before the detection of a HCC nodule.~   "
168425|NCT01361048|"~     The investigators are trying a combination vaginal product of higher dose metronidazole~     combined with miconazole to see if it is effective in treating vaginal trichomonas.~   "
168426|NCT01361035|"~     What's the purpose of this study? This 4-year study is designed: (1) to teach primary care~     physicians how to recognize low health literacy patients and effectively counsel them on~     cancer screening using risk communication and shared decision making and (2) to assess the~     impact of training on changes in physician communication behavior and changes in low health~     literacy patients' cancer screening behaviors. This study proposal is based on the hypothesis~     that physician training in cancer screening guidelines, health literacy, and communication~     skills will improve provider-patient interactions during encounters dealing with preventive~     health maintenance especially cancer screening.~      How will the proposed study be implemented? Thirty-two physicians in the New Orleans~     metropolitan area will be recruited and randomly assigned to one of two groups. The unit of~     randomization will be the health care organization or clinic. The intervention group will~     receive training in health literacy, cancer screening, risk communication and shared~     decision-making. The control group will not receive communication training until the end of~     the study. Physicians in both groups will undergo three clinic visits with standardized~     patients (actors trained to portray real patients; mystery shoppers) but they will not be~     aware that they are conducting visits with actors. The visits will occur at study enrollment~     and at 6 and 12 months. At the end of each clinic visit, the standardized patients will rate~     the physicians' communication skills. Each physician assigned to the intervention group will~     receive verbal feedback on communication skills from the standardized patients and complete a~     web-based tutorial. Physicians in the control group will not have access to the web-based~     tutorial until the end of the study.~      For each physician, 10-15 patients with limited health literacy will be recruited to the~     study. Each patient will rate his/her perceived involvement with care and global satisfaction~     with care at study enrollment and annually for three years. Age and gender-appropriate~     referral rates for breast, cervical and colorectal cancer screening and patients' receipt of~     such screening will be assessed annually for three years. All study physicians, regardless of~     group assignment, will receive performance feedback (report cards) on their cancer screening~     rates among low health literacy patients in their clinic.~   "
168427|NCT01361022|"~     The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm~     Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration~   "
168428|NCT01361009|"~     This is an open-label, multicenter, non-interventional, prospective observational study. we~     collect the safety information of pramipexole over 12w treatment. Parkinson disease patients~     with different severity who have already used pramipexole could be observed in this study. In~     the whole observation period, treatment decision was determined by physician and patient~     completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient~     withdraw, laboratory test.~   "
168429|NCT01360996|"~     The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder~     characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal~     gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS~     effectively reduces circulating androgens. Although OCs are the most common and one of the~     oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular~     menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of~     PCOS women with different body mass index (BMI) are limited. This study is being done to~     compare the hormone and metabolic changes after treatment with low-dose oral birth control~     regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS with~     different body weights.~   "
168430|NCT01360970|"~     Hepatitis A vaccine is the most frequently used traveller's vaccine, yet data on its ability~     to induce protective immunity in immunosuppressed travellers are scarce. The investigators~     assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis~     (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).~   "
168431|NCT01360957|"~     The purpose of this clinical trial is to study the therapeutic effect of black cumin water~     extract (Nigella sativa L.) on obesity and overweight~   "
168432|NCT01360944|"~     The aim of the exploratory study is to compare the dose-related efficacy of LAS41004 in a~     Psoriasis Plaque Test (PPT).~   "
168465|NCT01360515|"~     This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety~     and tolerance.~   "
168466|NCT01360502|"~     This is a prospective study designed to assess safety and potential influence of the MiroCam~     on cardiac pacemaker and implantable cardiac defibrillator.~   "
168568|NCT01359150|"~     A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response~     Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid~     Arthritis receiving CP-690,550 with and Without background Methotrexate~   "
168433|NCT01360931|"~     Lung cancer is the leading cause of cancer death in Hong Kong. Lung adenocarcinomas is the~     most common type, accounting for 70% of lung cancer and the molecular target of epidermal~     growth factor receptor (EGFR) gene mutation at exons 18 - 21 is present in about 50% of lung~     adenocarcinomas. The v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) mutations~     are commonly present in the other 50% that are EGFR wildtype. EGFR and K-ras mutations are~     found to be mutually exclusive in the same tumor. EGFR-tyrosine kinase inhibitor (TKI) can be~     used as treatment for EGFR mutated tumors while no specific targeted therapy can be~     recommended for EGFR wildtype tumors and these patients often receive chemoirradiation, which~     is toxic and clinical response is suboptimal. There is a need to find alternative molecular~     pathways/targets in EGFR wildtype lung adenocarcinomas.~      Even with EGFR mutations, good clinical response to EGFR-TKI is achieved in about 70% of~     these patients. This would mean suboptimal targeting of the EGFR gene or the presence of~     alternative pathways mediating tumor progression and susceptibility to therapy. Exploration~     of molecular pathways in lung cancer may allow for discovery of new molecular targets for~     therapeutic development.~      Neutrophil infiltration is frequently observed in lung cancer. Recognized similarities~     between neutrophils and cancer cells include (i) ability to circulate as single cells; (ii)~     target attachment via vascular system; (iii) target invasion. The major difference is that~     migrated neutrophils will undergo apoptosis while cancer cells can escape apoptosis.~      This led to the postulation that neutrophils and cancer cells may share similar inflammatory~     cascades by secreting a similar panel of proteases, and one of these could be neutrophil~     elastase (NE). Animal studies demonstrated that NE from neutrophils moves into lung tumor~     cells and mediates lung tumor growth via degradation of Insulin receptor substrate-1 (IRS-1),~     leading to activation of intracellular phosphoinositide-3-kinase (PI3k) and the v-akt murine~     thymoma viral oncogene homolog 1 (Akt) signaling pathways and the intracellular tyrosine~     kinase of the platelet-derived growth factor receptor (PDGFR).~      The aims of this study are to demonstrate NE activities and the subsequent signaling cascades~     activated in lung cancer cells, and to verify NE and its related pathway activation in~     clinical lung cancer specimen.~      This study will conclude the roles of NE and the therapeutic potential of NE/IRS-1/PI3K/PDGFR~     pathways in EGFR wildtype lung adenocarinomas.~   "
168434|NCT01360918|"~     Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a~     superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal~     atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac~     surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is~     beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the~     concomitant treatment of AF. The investigators aim to establish the effectiveness of~     incorporating epicardial pulmonary vein isolation into elective cardiac surgery.~   "
168435|NCT01360905|"~     The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA~     approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre~     term labor.~   "
168436|NCT01360892|"~     This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements~     will predict prospectively the incidence of hepatocellular carcinoma, the incidence and~     severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C~     patients.~   "
168437|NCT01360879|"~     This is a multi-center cross-sectional study in which the Real-time Tissue Elastography®~     measurements will be collected prospectively from patients with chronic hepatitis B or C~     virus presenting for liver biopsy.~   "
168438|NCT01360866|"~     To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in~     addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major~     Depressive Disorder (MDD)~   "
168439|NCT01360853|"~     The question being asked in this study is: Will patients with advanced pancreatic cancer live~     significantly longer if they are treated with a combination of Gemcitabine and ON 01910.Na~     than if they are treated with Gemcitabine alone? There are two parts to this study. In the~     first part of the study, patients with metastatic pancreatic cancer who have received no~     prior chemotherapy for this disease will be assigned by chance either to the group that will~     be treated with both Gemcitabine and ON 01910.Na (about 100 patients will be in this group)~     or, to the group that will be treated with Gemcitabine only (about 50 patients will be in~     this group). How long patients survive in the 2 groups will be compared. If it looks like~     there is no difference between the groups, the study will stop. If it looks like patients in~     the group that were treated with both Gemcitabine and ON 01910.Na survive longer, the study~     will continue into a second part where more patients will be treated in order to confirm and~     better understand the findings of the first part of the study.~   "
168440|NCT01360840|"~     The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD~     525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free~     survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic~     castrate-resistant prostate cancer (mCRPC).~   "
168441|NCT01360827|"~     The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a~     novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin~     and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell~     carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the~     dose levels.~   "
168442|NCT01360814|"~     This randomized clinical trial studies structured multidisciplinary intervention or standard~     medical care in improving quality of life (QOL) in patients receiving active cancer~     treatment. A structured multidisciplinary intervention may improve the QOL in patients~     receiving treatment for cancer. It is not yet known whether structured multidisciplinary~     intervention is more effective than standard medical care in improving QOL~   "
168443|NCT01360801|"~     The investigators seek to test the hypothesis that the improved version of high definition~     white light endoscopes and Narrow Band Imaging (NBI) are more accurate in detecting residual~     Barrett's Metaplasia and Dysplasia disease after previous resection or ablation treatments~     than current versions of these endoscopes.~   "
168476|NCT01360359|"~     The purpose of this randomized clinical trial of low back pain exercise programs is to~     determine if trunk control can be changed by core stabilization exercises. The proposed~     mechanism of pain reduction and functional improvement of core stabilization exercises is~     that it enhances trunk movement and muscle control. This study will provide preliminary~     evidence of the link between patient outcomes and treatment mechanisms.~      The investigators hypothesize that:~        -  both treatment groups will demonstrate significant improvements in pain and function;~        -  only subjects in the core stabilization group will demonstrate significant improvements~          in trunk movement and muscle control.~   "
168477|NCT01360346|"~     Recent studies suggest the employment of 'conscious' sedation (1) for critically high - risk~     patients (2), showing more efficacy then deep sedation (3). The investigators want to compare~     intravenous injection versus enteral sedative drugs administration, purposing to maintain a~     'conscious' sedation level compatibly with the needed cares, invasive procedures, and medical~     and nursing surveillance.~   "
168569|NCT01359137|"~     This is a Cochise County experiment with innovative probation supervision practices. Subjects~     are assigned to one of three supervision conditions.~   "
168444|NCT01360788|"~     Recently integrated in clinical practice, the Global Initiative for Chronic Obstructive Lung~     Disease (GOLD) classification states that a mild (stage I) chronic obstructive pulmonary~     disease (COPD) is present, in a smoker, when the postbronchodilator forced expired volume in~     1 second (FEV1) to forced vital capacity (FVC) ratio is < 0.7. A major change that was~     introduced by the GOLD classification system was that COPD could be diagnosed despite an FEV1~     that is within normal predicted values (above 80% predicted). Because it suggests diagnosing~     and detecting COPD earlier than done until very recently in medical practice, the GOLD~     standards bring in a new reality to clinicians. In fact, this novel COPD classification comes~     with new research challenges because the functional impacts and systemic consequences related~     to COPD are mostly documented in patients with moderate to severe stages with little~     information specifically in GOLD stage I COPD. This information is important if the~     investigators are to convince physicians that GOLD stage I COPD needs to be diagnosed and~     eventually treated.~      The investigators aimed to characterize GOLD stage I COPD patients according to~     activity-related dyspnea. More specifically, our objectives were to compare:~      i) baseline pulmonary function ii) exercise capacity iii) quadriceps muscle function iv)~     levels of physical activity in daily life~      between symptomatic (Sx) GOLD stage I COPD patients, asymptomatic (ASx) GOLD stage I COPD~     patients and healthy control subjects (CTRL). The investigators reasoned that exercise~     tolerance and physical activity levels would be decreased in Sx GOLD stage I COPD patients as~     it would be similar between ASx GOLD stage I COPD patients and CTRL.~   "
168445|NCT01360775|"~     Objective: To assess the effect of a nutritional educational intervention on the risk of~     malnutrition dependent patients aimed at the caregivers.~      Material and methods:~      Intervention study with control group, with 200 patients randomized selected, in a Home Care~     Program of 5 Primary Care Centers, malnourished and dependents, older than 65 years and with~     a caregiver.~      Socioeconomic and cultural characteristics of the patient and the caregiver are collected.~     Mini Nutritional Assessment (MNA), food intake, anthropometric and serum parameters of~     nutritional status: albumin, prealbumin, transferrin, hemoglobin, lymphocyte count, iron,~     ferritin, are evaluates on 0- 6-12 months. Also evaluated dentures, basic activities of daily~     living (Barthel test), cognitive state (Pfeiffer test) status of mood (Yesavage test).~      Prior to the intervention, the educational procedure and the design of educational material~     are standardized among nurses. The nurses make an initial session for caregivers and~     monitored the education at home monthly (4 visits) up to 6 months. NANDA (NORTH AMERICAN~     NURSING DIAGNOSIS ASSOCIATION) specific methodology of the Nursing profession is used. The~     investigators studied the effect of the intervention on the caregivers on the patient's~     nutritional status by the MNA test, diet, anthropometry and biochemical parameters.~      Bivariate normal test statistics and multivariate models were created to adjust the effect of~     the intervention.~      The program SPSS / PC was used.~   "
168446|NCT01360762|"~     Visceral leishmaniosis (VL) is widely reported in Ethiopia, with about 30% of cases being~     associated with human immunodeficiency virus (HIV). In absence of antiretroviral treatment~     (ART), poor prognosis, high mortality and high relapse rates are characteristic of Ethiopian~     VL patients with HIV co-infection. Conversely, co-infection can be successfully managed via a~     combination of effective treatment of the initial episode, timely ART and prevention of~     relapses.~      Actually, until cellular immunity returns with ART, the patient is at risk of VL relapses,~     which can result in death, severe illness, reduced ART efficacy, drug-resistance and possibly~     transmission of drug-resistant Leishmania donovani. Patients most vulnerable to relapses are~     those with high levels of immunosuppression, with previous VL episodes, or with opportunistic~     infections (OIs). The most important factor to prevent relapses seems to be the clearance of~     visible parasites.~      Limited studies in Europe show that HIV co-infected patients may benefit from secondary~     prevention with antimonials (part of mainstay treatment for VL in Ethiopia) and pentamidine~     (PM), not used for VL treatment in Africa. Such maintenance treatment has not been studied in~     African VL, but the poor outcomes without secondary prevention highlight a need of better~     care to patients at risk of relapse.~      This prospective cohort study aims at documenting the patient's outcomes of secondary~     prophylaxis with PM in VL-HIV co-infection, in terms of time to relapse or death, safety and~     feasibility, before it can be considered for general use in Ethiopia. A placebo group is not~     included, due to the clear advantages of the intervention to the patient population.~   "
168447|NCT01360749|"~     Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina~     (lidocaine cream) in reducing pain associated with laser hair removal in women.~   "
168448|NCT01360736|"~     The investigators propose to test the efficacy of a brief, readily accessible, and~     personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown,~     2012).~   "
168449|NCT01360723|"~     The investigators previously pointed out the significant association between urinary arsenic~     profiles and urothelial carcinoma (UC) risk through a 12-year follow-up study. Further, the~     investigators observed the increased UC risk in people with lower plasma folate and higher~     homocysteine than those with higher plasma folate and lower homocysteine in 2010.~     S-adenosylmethionine (SAM) is one factor included in one-carbon metabolism pathway and is the~     main donor of methyl group in cells. The ratio of SAM and its metabolite~     S-adenosylhomocysteine (SAH) not only reflected the intake level of dietary folate but also~     demonstrated the extent of global DNA methylation. These factors might play important roles~     in UC carcinogenesis. The investigators would expect to take three years to explore the~     interactions among global DNA methylation, one-carbon metabolic pathway factors, urinary~     arsenic profiles, the polymorphisms and haplotype of Glycine N-methyltransferase (GNMT) and~     UC. In the first year, the investigators would measure the levels of plasma folate,~     homocysteine, SAM and SAH and evaluate the associations between these factors and UC risk. In~     the second year, the investigators would set up the method of immunohistochemistry stain and~     compare the differences between the global DNA methylation from bladder tissues and blood. In~     the last year, this investigators would analyze the GNMT gene polymorphism and haplotype~     variation. At the same time, the investigators would explore the impact of GNMT genetic~     variation and global DNA methylation on UC risk. Based on the results from our research, the~     investigators might propose that the decreased ratio of SAM/SAH resulted in UC risk~     increased. This mechanism might be through the changed levels of urinary arsenic profiles and~     global DNA methylation.~   "
168450|NCT01360710|"~     Obesity is a major risk factor for the development of hypertension. Based on population~     studies, risk estimates indicate that at least two-thirds of the prevalence of hypertension~     can be directly attributed to obesity. Obesity per se is commonly associated with activation~     of the sympathetic nervous system with a predominant increase in sympathetic outflow to the~     kidneys and the peripheral vasculature and there is now conclusive evidence that heightened~     sympathetic nerve activity is a major contributor to the elevation in blood pressure~     associated with obesity, particularly in young subjects. In line with these findings, dietary~     weight loss has repeatedly been demonstrated to result in reduced sympathetic nerve activity~     and lower blood pressure levels.~      Several lines of evidence have well documented the significant role of SNS activation in~     obesity associated hypertension and target organ damage. Weight loss is the preferred~     treatment option for obesity and its consequences and reduces both SNS activation and blood~     pressure. In the real world however, weight loss maintenance is rarely achieved in obese~     patients highlighting the urgent need for alternative treatment strategies. Given the crucial~     involvement of SNS activation in various aspects of the obesity related increase in blood~     pressure, target organ damage and cardiovascular risk, the use of sympatho-inhibitory agents~     at an early stage is an obvious choice.~      The investigators therefore plan to examine the effects of the centrally sympatholytic agent~     moxonidine on blood pressure and the morning surge in blood pressure, sympathetic activity,~     regression of early target organ damage (heart, kidney and endothelium), metabolic and~     inflammatory markers in young obese subjects with hypertension in a randomized, double-blind~     clinical trial with the angiotensin receptor blocker irbesartan as an active comparator to~     achieve similar blood pressure reductions in both groups. The investigators hypothesize that~     moxonidine treatment will result in significant improvements in these outcome parameters and~     beneficial effects beyond simple blood pressure reduction.~      Findings from this study could pave the way for an early and pathophysiology- tailored~     treatment strategy of obesity related hypertension and its detrimental consequences.~   "
168451|NCT01360697|"~     In this demonstration project (JADE in Jiangsu & Anhui Program, JADE-JA in short) led by key~     opinion leaders in the field of diabetes and endocrinology in Jiangsu and Anhui area and~     supported by the ADF, shall recruit 4800 type 2 diabetic patients attending medical~     out-patient clinics in the area to compare the effects of usual versus structured care~     (non-JADE vs JADE) on metabolic control, quality of life and behavioral changes. After~     explanation by trained doctors and nurses and with written informed consent, patients will be~     randomized to either the JADE or non-JADE group. The former encompasses all components of the~     structured care delivered by a trio-team of doctor, nurse and Healthcare Assistant (HCA)~     while the non-JADE group only consists of comprehensive assessments (CA) at baseline and~     12-month with patients managed in the usual manner thereafter. At the end of 12 months, all~     patients will undergo repeat comprehensive assessments for comparison of rates of attainment~     of treatment targets, behavioral changes, quality of life and default rates. The~     acceptability of the JADE-JA Program by patients and the trio-team will also be evaluated.~      The investigators hypothesize that the use of state of the art information technology to~     record, manage and analyze the large amount of clinical information generated during various~     consultation visits will improve the effectiveness and efficiency in implementing these care~     protocols through decision support and regular feedback to both patients and care team.~   "
168452|NCT01360684|"~     Infertility is the most common reason women (aged 20-45yrs)see their GP, affecting 1 in 7~     couples. Measuring basal body temperature is a technique that has been used since the 1930's~     to attempt to predict ovulation. Current NICE guidelines don't recommend the use of BBT~     charts to predict ovulation, as it has not been established to reliably confirm ovulation.~      The DuoFertility sensor a CE marked Class la device provides a continuous accurate measure of~     axilla temperature whilst worn under the arm.~      The investigators plan to compare the temperature measurements of the DuoFertility sensor~     with the gold standard transvaginal ultrasound scan obtained during 10 infertile women's~     menstrual cycles, up to 10 cycles per women.~      The investigators aim to investigate if continuous axillary skin temperature measurement~     obtained from the DuoFertility sensor, provides comparable results for identifying the~     occurrence of ovulation as the gold standard transvaginal ultrasound scan.~   "
168453|NCT01360671|"~     To determine the efficacy of iv sildenafil in term and near term infants with PPHN~     (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric~     oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control~     group not treated with sildenafil.~   "
168454|NCT01360658|"~     Solar urticaria is a rare but debilitating disease that can severely impact the quality of~     life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic~     drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or~     immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic~     urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7~     patients, to dramatically improve 71% of patients. In an open-label prospective multicenter~     study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10~     patients affected with severe and refractory solar urticaria.~   "
168455|NCT01360645|"~     To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive~     substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in~     patients with Major Depressive Disorder who demonstrate an incomplete response to a~     prospective trial of the same assigned FDA approved ADT~   "
168456|NCT01360632|"~     To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive~     substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in~     patients with Major Depressive Disorder who demonstrate an incomplete response to a~     prospective trial of the same assigned FDA approved ADT~   "
168457|NCT01360619|"~     The researchers believe that the multifunction Keito devices shares with TANITA TBF-300~     (K014009) the same efficacy on the body fat measurement. Even if the body contact points are~     not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate~     gives results as similar as the multifunction keito does.~   "
168458|NCT01360606|"~     This is a phase I dose escalation study. Dose escalation will be via the traditional up and~     down scheme. SBRT:~      Patients will receive one of the following radiation regimens:~        -  50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.~        -  60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.~        -  75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period.~   "
168459|NCT01360593|"~     The current study seeks to further investigate the impact of up-front systemic therapy in~     combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic~     adenocarcinoma.~   "
168460|NCT01360580|"~     Epidemiology study for evaluation of incidence of swallowing disorders (SD) after prolonged~     invasive ventilation (more than seven days), using a clinical statement. All consecutive~     patients are screened, and clinical evaluation is performed during 48h after patient's~     extubation. If a SD exist, a new evaluation is realized 48h after. Three groups will be~     created (1.no SD, 2.transitory SD and 3.persistent SD (eg persistent after 48h)). Data~     complementary are notified at day 28 (pneumonia? nutritional status?)~   "
168467|NCT01360476|"~     This project seeks to reduce the disparity in hypertensive heart disease which exists for~     African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure~     (BP). The investigators are targeting a highly vulnerable, often neglected subject population~     which stands to benefit tremendously from better BP control and a corresponding decrease in~     heart damage. HTN occurs early in life and more often in African-Americans, reducing both~     quality and quantity of life. Inner-city African-Americans with HTN utilize the emergency~     department (ED) for chronic BP management. Like cardiovascular disease, vitamin D deficiency~     disproportionately affects African-Americans. Vitamin D is thought to play an important role~     in cardiovascular health. Vitamin D replacement in those who are deficient has been thought~     to reduce the cardiovascular disease, especially if initiated early before irreversible~     damage has occurred, but this has yet to be tested in a prospective clinical trial.~     Accordingly, this proposal was designed to investigate the relationship between vitamin D and~     cardiac damage (as identified on cardiac magnetic resonance imaging) in a cohort of~     African-American, vitamin D deficient hypertensive patients without prior history of heart~     disease.~      The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in~     vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment, which,~     if shown to be effective could improve the existing approach to a widely accessible,~     cost-effective option.~   "
168468|NCT01360463|"~     According to UNAIDS, Indonesia is experiencing one of the most rapidly expanding HIV/AIDS~     epidemics in Asia. The epidemic in Indonesia has been fueled by injection drug use among~     heroin users and the national response includes the scale-up of methadone maintenance~     treatment.~      Drug counseling is considered to be an integral part of methadone treatment, but few studies~     have been designed to assess its benefits and costs. In settings such as Jakarta, data~     regarding the costs and benefits of drug counseling have critical public heath relevance.~      The investigators propose to conduct a prospective randomized trial to evaluate the efficacy~     of integrated drug and HIV counseling among injecting drug users. This study will be~     conducted at six methadone clinics in Jakarta, Indonesia where the HIV prevalence among~     injecting drug users ranges between 50- 86%, with collaborators from the Drug Dependence~     Hospital in Jakarta, the University of Pennsylvania and Yale University. The specific aims of~     this four year study are to evaluate the impact of Behavioral Drug and Risk Counseling~     (BDRC)—a low intensity, cognitive behavioral approach that integrates drug counseling and~     risk reduction intervention. Those assigned to the BDRC arm will be compared to those who~     receive treatment as usual which includes an initial risk reduction intervention and~     counseling as needed. The investigators hypothesize that the structured, low intensity BDRC~     approach will be more cost effective and result in higher rates of retention in treatment,~     lower rates of drug use and lower rates of HIV risk.~      To test these hypotheses, the research team in Jakarta will recruit 300 injecting drug users~     as they enter treatment at the Drug Dependence Hospital and its five satellite programs.~     Following informed consent procedures, research staff will randomize participants to either~     the BDRC intervention or to treatment as usual. All subjects will be fuly assessed at~     baseline and months 3, 6, 9, and 12.~      The proposed work will be build on collaborations that have been established with the~     Indonesian Investigator Adhi Nurhidayat,MD during his NIDA INVEST Fellowship at University of~     Pennsylvania when he spent time with David Metzger, PhD and George Woody, MD. It will also~     extend findings from a WHO study on substitution therapy of opiates and HIV/AIDS that was~     completed by Riza Sarasvita, MS,MHS (former NIDA Humphrey Fellow at Johns Hopkins University)~     and her colleagues at The Drug Dependence Hospital Jakarta, Indonesia.~   "
168469|NCT01360450|"~     Thousands of critically ill infants (and children) are exposed to opioids and benzodiazepines~     to achieve sedation and analgesia as part of routine care in neonatal and pediatric intensive~     care units. While the use of these agents are undisputedly beneficial in reducing pain and~     anxiety, improving ventilation, reducing pulmonary vascular resistance and improving~     outcomes; the consequence is often the development of tolerance and physiologic dependence -~     similar to prenatal exposure from these same classes of drugs. The investigators have~     recently reported the results of randomized placebo control trial showing that the addition~     of clonidine (central alpha 2 agonist) to tapering doses of opioids was efficacious and safe~     in treating opioid dependence in infants who had moderate to severe neonatal abstinence~     syndrome from prenatal drug exposure to opioids. Currently, the investigators propose to~     perform a double-blind, randomized placebo control trial in a cohort of critically ill~     infants without prenatal drug exposure at Johns Hopkins Hospital to test the overall~     hypothesis that early addition of clonidine to a cohort of critically ill neonates on~     mechanical ventilation who are receiving opioids and benzodiazepines for analgesia and~     sedation will be efficacious and safe in reducing both the incidence and severity of~     withdrawal symptoms (NICU-NAS); as well as, reducing the time to complete sedative and~     analgesic drug detoxification. The hypothesis will be tested by addressing 2 specific aims~     that will determine: 1) the efficacy and safety of clonidine in critically ill infants, and~     2) pharmacokinetics and pharmacodynamics using population-based pharmacokinetics in this~     vulnerable infant population who have only been exposed to these drugs as part of their~     routine care. Many standard of care practices are incorporated in neonatal and pediatric~     care prior to evidence based studies. This proposal will fill a much needed gap in~     translating what the investigators have learned about basic mechanisms mediating dependence~     and withdrawal to proven therapies for vulnerable pediatric populations.~   "
168470|NCT01360437|"~     This is a single-center, randomized, single-blind, investigator-initiated pharmacological~     study with a crossover design. Patients with acute coronary syndrome (ST-elevation myocardial~     infarction, non-ST elevation myocardial infarction, unstable angina) and presenting high~     on-clopidogrel platelet reactivity as assessed with the VerifyNow assay (platelet reactivity~     units PRU≥235) 24 hours post percutaneous coronary intervention (PCI), will be randomized~     after informed consent in a 1:1 ratio to either prasugrel 10mg/d or ticagrelor 90mg twice a~     day for 15 days. Platelet reactivity assessment will be performed at Day 15±2 days and then a~     crossover directly to the alternate treatment group for an additional 15 days period, without~     an intervening washout period will be carried out. Patients will return at Day 30±2 days for~     platelet reactivity assessment.~   "
168471|NCT01360424|"~     The purpose of this study is to analyse efficacy of teriparatide treatment in patients with~     new forms of inherited low-turnover osteoporosis.~   "
168472|NCT01360411|"~     In this single centre study we study the use of endoscopic ultrasonography (EUS) combined~     with elastography in order to separate malignant tissue from benign tissue in and adjacent to~     the upper gastrointestinal tract.~   "
168473|NCT01360398|"~     The aim of this study is to generate epidemiological data to further explore determinants of~     Chronic Obstructive Pulmonary Disease (COPD) and the contribution of bacterial and viral~     pathogens to Acute Exacerbation of COPD (AECOPD) episodes.~   "
168474|NCT01360385|"~     Recent studies have shown a remarkably positive effect of 6 monthly injections of Ranibizumab~     on eyes with CRVO. The disease may cause severe sight threatening complications, partly due~     to restrictions in blood flow and oxygenation . Although Ranibizumab has been shown affective~     to reduce oedema of the retina, it is not known whether the drug ameliorates or aggravates~     restrictions in oxygenation.~      The Oxymap oximeter allows a non-invasive measurement of the oxygen saturation in retinal~     vessels and thus the state of retinal oxygenation.~      The primary objective of the study is to evaluate the effects of injections of Ranibizumab on~     the retinal oxygen saturation in eyes with newly diagnosed central retinal vein occlusion~     (CRVO),~      The secondary objective is to evaluate the effects of injections of Ranibizumab on visual~     acuity and retinal oedema in eyes with different degree of ischemia.~   "
168475|NCT01360372|"~     It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates)~     in patients will result in increased tube feeding rates with more frequent nutrition at goal~     calorie rate.~   "
168478|NCT01360333|"~     When subjected to fluid loss or fluid deficiency irrespective of disease or environmental~     factors it is discussed how to rehydrate or how to hydrate prophylactic.~      In medical care it is common to give infusions. However it has increasingly become common to~     hydrate the patient through the mouth even early after bowel surgery. Moreover it is more~     simple to provide energy the natural way.~      Which fluid to give, depends on several factors such as possibility to drink, the volume and~     emptying of the stomach as well as the fluid absorption in the bowel.~      The provided fluid can also influence this process depending on temperature,~     osmolality/tonicity and composition (carbohydrates or salts).~      In this study we wish to study the speed with which the provided fluid is absorbed by the~     bowels and how fast the fluid is distributed to the different body compartments depending on~     it's composition.~      The three fluids will be either tap water, high sodium chloride and a carbohydrate rich~     fluid.~   "
168479|NCT01360320|"~     This is a randomized, placebo controlled, multicentric trial to investigate the effect of~     diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG),~     the major polyphenol of green tea, on the recurrence of colon adenomas.~   "
168480|NCT01360307|"~     The Clinically Useful Depression Outcome Scale (CUDOS) is a brief, self-administered~     instrument that not only evaluates depressive symptoms but also both functioning and quality~     of life. The assessment of patients´ perspective may provide valuable information that could~     be lost if relaying only on clinician evaluation. The purpose of this study is to achieve a~     psychometric validation into Spanish of the CUDOS scale in patients with major depression~     disorder in a primary care setting.~   "
168481|NCT01360294|"~     The aim of this study is to develop a patient reported outcome tool specific to small airways~     disease, which assesses symptoms and signs of small airways disease and may help in addition~     to FEF50% to discriminate between asthmatic patients with and without small airways disease.~   "
168482|NCT01360281|"~     The purpose of this study is to compare the efficiency of neuromuscular electrical~     stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and~     on recovering motor function of patients with knee osteoarthritis.~   "
168483|NCT01360268|"~     Rationale for this study:~      Correction of hypocholesteremia and insulin resistance after successful eradication of HCV by~     combination therapy of interferon and ribavirin has been shown in several studies. The~     majority of these studies examined genotype 1 and some genotype 3 patients, but it is not~     clear if the same results can be achieved in other genotypes of HCV.~      Moreover, clinical data of the relationships between different adipocytokines, metabolic~     profiles, and HCV and treatment is of value to further understand the mechanisms for~     HCVrelated metabolic alterations. The present proposal is designed to address the paradox of~     HCV-related metabolic alterations/adipocytokine alterations and to determine how BMI~     influences the HCV-related metabolic alteration/adipocytokine aterations by collecting and~     analyzing the samples from humans with HCV infection prior to and after combination of~     peginterferon alpha-2b plus ribavirin~      For metabolic alternations:~      Lipid profile: After treatment, responders in both genotype I and II will experience more~     increase of cholesterol levels and LDL levels than nonresponders/ relapseres. Insulin~     resistance: After treatment, responders with both genotype I and II will experience more~     decrease of HOMA-IR than nonresponders/ relapseres; higher percentage of responders will~     achieve HOMA-IR < 2 than nonresponders/ relapseres B. For adipocytokine alternation, this~     study is more of exploratory propose as there is still little well established consensus.~   "
168484|NCT01360255|"~     Hepatocellular carcinoma (HCC) is one of the tumors with an increasing incidence worldwide.~     Often treatment possibilities are limited and only palliative treatment such as a~     transarterial chemoembolisation (TACE) is possible. Therapeutic response is evaluated three~     months after TACE by imaging techniques (CT, MRI). In some HCC patients the tumor marker AFP~     ( alpha-fetoprotein) is elevated, but not all patients show this elevation. In the last years~     new tumor markers such as AFP-L3 (subfraction of AFP) and des-y-carboxyprothrombin (DCP) have~     been examined. In this clinical trial the course of these markers are examined after TACE in~     order to receive hints if the patient will be a therapeutic responder.~      Furthermore the investigators are interested in the quality of life after TACE. Patients~     receive a questionnaire with regard to the quality of life before and 3 months after TACE.~   "
168485|NCT01360242|"~     In the setting of primary Percutaneous Coronary Intervention (PCI), the investigators~     hypothesize that a 24-48 hour delay strategy of stenting after successful thrombus aspiration~     and establishment of Thrombolysis In Myocardial Infarction (TIMI)-3 flow with optimal~     antithrombotic therapy may decrease the risk of MicroVascular Obstruction (MVO) as assessed~     by Cardiac Magnetic Resonance Imaging (CMRI).~   "
168486|NCT01360229|"~     This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can~     safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will~     receive either real or sham acupuncture twice weekly for six weeks.~   "
168487|NCT01360216|"~     The purpose of the study is to measure whether an education and training intervention for~     clinicians and contraceptive counselors on long-acting reversible contraception (LARC) will~     result in greater use of the methods among contraceptive patients.~   "
168488|NCT01360203|"~     The purpose of this study is to compare the effect of implementing wireless remote monitoring~     combined with structured telephone monitoring, versus current care, on variation in~     rehospitalization among older patients hospitalized with heart failure at six medical~     centers.~   "
168489|NCT01360190|"~     The overall goal of this proposal is to study quantitative electroencephalography (QEEG ) as~     a method for the detection of antidepressant treatment response. The investigators have~     developed a QEEG algorithm called cordance that appears to provide much the same~     information about brain function as PET or SPECT scanning, and has shown patterns of brain~     function that appear to be indicative of depression. Of greatest interest is that these~     patterns appear to normalize in response to antidepressant treatment.~   "
168490|NCT01360177|"~     This is a treatment protocol designed to accompany the ongoing institutional 124I PET/CT~     pilot imaging study for patients with invasive breast cancer. Women whose tumors express NIS~     [Na+I- symporter, sodium iodide symporter] and demonstrate radioiodide uptake on 124I PET/CT~     scans will be eligible for 131I treatment if, (1) tumor dosimetry calculations yield a~     cumulative radiation dose of at least 30Gy in target tumor, (2) estimated cumulative thyroid~     irradiation is less than 500 cGy and, (3) the therapeutic dose of 131I is in the range of 25~     to 100 mCi.~   "
168491|NCT01360164|"~     The Hereditary Ataxias are a group of genetic disorders characterized by slowly progressive~     incoordination of gait and often associated with poor coordination of hands, speech, and eye~     movements. Current treatments for Hereditary Ataxias are mainly pharmacological,~     rehabilitative, or psychological treatments，while no effective treatment available. Stem Cell~     therapy is a novel and promising therapeutic strategy for Hereditary Ataxias treatment. In~     this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells~     transplantation will be evaluated in patients with Hereditary Ataxias.~   "
168492|NCT01360151|"~     This is a prospective, comparative control analysis. The investigators want to evaluate the~     aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal~     vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic~     therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth factor.~   "
168493|NCT01360138|"~     Ligamentum flavum in the cervical region is thin or not fused at the midline. The~     investigators inferred that the size and elasticity of the ligamentum flavum, in combination~     with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in~     some patients. If so, the investigators hypothesized that the paramedian approach would be~     advantageous for finding cervical epidural space more easily during cervical epidural steroid~     injections (CESIs).~   "
168494|NCT01360125|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the~     laboratory may help doctors predict how well patients will respond to treatment.~      PURPOSE: This research study studies biomarkers in samples from patients with newly diagnosed~     acute myeloid leukemia treated with cytarabine-based chemotherapy.~   "
168495|NCT01360112|"~     A vaccine which interrupts malaria transmission is a critical tool to achieve the ultimate~     goal of eradication of this disease. Transmission blocking vaccines work by inducing antibody~     in vaccinated individuals that inhibits the development of malaria parasites in the mosquito,~     thus interrupting the cycle of transmission to the next human host. Efficacy of these~     vaccines may be estimated by in vitro membrane feeding assays using immune sera and~     laboratory strain mosquitoes, but these assays need to be qualified to determine to what~     extent they are predictive of transmission blocking in the field. Clinical trials of~     transmission blocking vaccines are also anticipated and have started in this community. This~     protocol will use a nested casecontrol cohort design to compare results of mosquito feeding~     assays in a malaria exposed population in Bancoumana and surrounding villages in Mali.~     Households will be identified using census data and individuals will be consented for~     participation. Malaria smears will be obtained at monthly visits, and gametocytemic~     individuals will be asked to participate in direct feed experiments using insectary-raised~     mosquitoes. Infectivity in these mosquitoes will be compared against those of mosquitoes fed~     in membrane feeding assays in Mali and the USA. Data will also be obtained on gametocyte and~     parasite carriage rates through the year. A total of 250 volunteers from Bancoumana, ages 3~     months to 50 years, were initially enrolled in 2011. In 2012, an additional 250 adults from~     Bancoumana were enrolled and participants older than 5 years of age who were enrolled in 2011~     and wanted to continue participation were re-enrolled into the study. A transmission blocking~     vaccine trial started in May 2013, and has enrolled participants from this adult cohort in~     that study. Up to 50 new adults from Bancoumana and surrounding villages will be enrolled in~     2014 and those volunteers previously enrolled into the study over theage of 5 years old will~     be offered re-enrollment into the study.~   "
168496|NCT01360099|"~     Background:~      - Osteoporosis is a condition where the bone becomes more brittle and more likely to break as~     a person ages. The drugs that people take to treat this condition have prevented many common~     hip fractures. But these drugs may be associated with problems in the shape and structure of~     the hip bone after many years of use. These changes in the hip bone may lead to an unusual~     kind of hip fracture. These fractures are very rare, so it is hard to study them. Researchers~     want to learn more about these fractures.~      Objectives:~      - To compare hip x-rays of three groups: people who have been taking osteoporosis drugs for~     several years, those who have just started taking them, and those who have never taken these~     drugs.~      Eligibility:~        -  People at least 50 years of age who have been taking osteoporosis drugs for at least 5~          years.~        -  People at least 50 years of age who have been taking these drugs for less than 1 year.~        -  People at least 50 years of age who have never taken these drugs.~      Design:~        -  All participants will have three total visits over 3 years.~        -  At the first visit, those taking part will have a medical history and physical exam.~          They will complete a questionnaire about medication use and bone health. They will also~          have an x-ray of the hips and pelvis, and have a bone density scan (the kind used to~          test for osteoporosis) of the hips.~      Those in the study will repeat these exams and medical history questions at followup visits.~     These visits will take place 18 months and 36 months after the first study visit.~        -  At any of these visits, participants who may have a hip fracture that does not show up~          on the x-rays will have an imaging study to examine the bone more closely.~        -  Participants who receive a hip replacement or suffer from a broken bone at any time~          should inform the study researchers as soon as possible.~   "
168497|NCT01360086|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin~     calcium, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     more than one drug (combination chemotherapy) together with cetuximab before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving~     these drugs after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin,~     and leucovorin calcium together with cetuximab and to see how well they work in treating~     patients with adenocarcinoma of the stomach or gastroesophageal junction.~   "
168498|NCT01360073|"~     The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary~     death associated with use of monotherapy low dose ASA (single antiplatelet) as well as~     concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in patients~     with serious coronary heart disease using two UK primary care databases.~   "
168499|NCT01360060|"~     Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia~     in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an~     effective as an analgesic adjuvant. The investigators evaluated the analgesic effect of~     magnesium in parturients undergoing Cesarean section.~   "
168500|NCT01360047|"~     The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary~     death associated with use of monotherapy low dose ASA (single antiplatelet) as well as~     concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time~     users of low dose ASA for secondary prevention using a UK primary care database.~   "
168501|NCT01360034|"~     The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin~     as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms).~   "
168502|NCT01360021|"~     This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the~     Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.~   "
168503|NCT01360008|"~     Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation~     will be investigated in a cohort study design in experienced electrophysiologic (EP) centers~     analyzing propensity-matched cohorts.~   "
168504|NCT01359995|"~     The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients~     with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan~     University hospital.~   "
168510|NCT01359917|"~     The hypotheses of this study were that:~        1. HIV lipodystrophy is associated with psychological morbidity relating to body image,~          anxiety and depression.~        2. Treatment of HIV lipodystrophy using autologous fat transfer, polylactic acid or~          Bio-alcamid, is associated with an improvement in psychological morbidity and anatomical~          volume of treated areas.~        3. The DI3D system is a valid and reproducible method of recording and measuring facial 3-D~          volume.~   "
168511|NCT01359904|"~     Background:~      Type II diabetes is a disease that affects more than 246 million people worldwide. Most~     importantly, one of the complications of type II diabetes is kidney damage and this has lead~     to many patients seeking hemodialysis treatment, a type of kidney replacement therapy.~     However, during hemodialysis treatment, many patients are greatly at risk for having their~     blood sugar drop below normal and this can lead to neurological problems. Also, it has been~     reported that hemodialysis patients who have poorer control of blood glucose levels are at~     risk to developing heart problems. It has been shown that adding 5.5 mmol/L of glucose in the~     hemodialysis treatment can reduce the chances of having an abnormal decrease in blood glucose~     levels. Currently, some institutions use 10 mmol/L of glucose (instead of 5.5 mmol/L) in the~     hemodialysis treatment, however, there is little documented support to justify for this~     action.~      Objective:~      The investigators are would like to explore the effects of use of 10 mmol/L of glucose in~     hemodialysis treatment and to determine if it worsens control of blood glucose levels, both~     during the treatment sessions and over the long term in type II diabetes patients. Also,~     patients on hemodialysis are prone to infection, so we will also observe if there is any~     change in infection rate among these patients with increased glucose in the treatment.~      Methods:~      The study will consist of 40 patients who will be randomly split into 2 groups. One group~     will be treated with 5.5 mmol/L glucose in the hemodialysis treatment and the other group~     will have 10 mmol/L glucose in the treatment. During the hemodialysis treatment, patient~     blood glucose will be measured at set intervals to check for any acute drops in glucose~     levels. Also, to assess long-term control of blood glucose levels, each patient will have 2~     blood tests, one at the start and another at the end of the experiment. Signs of infection~     will be checked at the start of each session. Each patient will remain in their group for the~     duration of the study, which is 12 weeks.~   "
168512|NCT01359891|"~     The protein ST2 is a member of the interleukin-1 receptor family. Blood concentrations of the~     soluble isoform of ST2 (sST2) are increased in inflammatory and heart diseases and are~     considered a prognostic marker in both. The Presage™ST2 assay was recently shown to meet the~     needs of quality specifications of laboratory medicine. Soluble urokinase plasminogen~     activator receptor (suPAR) levels reflect inflammation and elevated suPAR levels are found in~     several infectious diseases and cancer. Both sST2 and suPAR have recently been introduced as~     sensitive biomarkers for patients with septicemia. Both may be promising or even superior~     alternatives to currently established sepsis markers leading to an improvement of outcome in~     patients with septicemia. However, a clinical study which clarifies kinetics of values over~     time/possible correlation with causative pathogen/progress/deterioration of septic patients~     is urgently needed before these biomarkers can be established in clinical routine.~      Primary study objectives To clinically evaluate sST2 and suPAR in patients with bacteremia~     /septicemia. To correlate results with causative bacterial organisms, response to or failure~     of antiinfective treatment, severity of clinical status as well as outcome.~      To study the kinetics of the test results and to correlate the sST2/suPAR results with other~     well established infection markers (e.g. C-reactive protein, procalcitonin, blood counts).~      Natural endpoints of the study will be patient's death or complete recovery.~      This is an explorative study. To meet the objectives both novel biomarkers will be clinically~     evaluated in a cohort of 500 in-patients with septicemia at the University Hospital Graz.~     Starting the day a patient's blood culture turned positive the investigators will collect~     samples every 12h within the first two days and then every 24h.Measurement of sST2 and suPAR~     values will be done retrospectively. To analyze clinical sensitivity/specificity of the novel~     biomarkers sST2 and suPAR as prognostic factors for development of bacteremia/septicemia, a~     second cohort consisting of 250 in-patients will be investigated in a longitudinal matter.~     Patients without a previous positive blood culture test during the current episode of disease~     for which blood cultures are ordered by a physician will be included and sST2 and suPAR~     levels will be determined from samples taken simultaneously with this first blood cultures.~   "
168513|NCT01359878|"~     Severe maternal bleeding is a serious complication of birth and causes 125.000 deaths~     worldwide each year. The investigators aim to investigate if early treatment with fibrinogen~     concentrate versus saline can reduce the incidence of blood transfusion in women with~     postpartum haemorrhage.~      A low level of fibrinogen has been associated with increased blood loss and transfusion~     requirements in different clinical settings including obstetrical bleeding. Early up-front~     treatment with fibrinogen may reduce incidence of transfusion by securing optimal haemostatic~     capacity in women with postpartum haemorrhage.~      The investigators plan to enrol 245 patients on four hospitals in the Capital Region of~     Denmark during a two year period.~      As safety measure the investigators plan to use TEG®/Functional Fibrinogen/Rapid-TEG as~     haemostatic monitoring of all participants during the trial: Baseline test is taken at~     inclusion before administration of fibrinogen concentrate/placebo. Further tests are taken~     immediately after intervention, 4 hours and 24 hours after. Baseline test is blinded to the~     providers of treatment - the rest is clinically available.~   "
168514|NCT01359865|"~     To compare analgesia and orthopedic rehabilitation milestones in patients receiving either~     spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with~     lumbar plexus block.~   "
168515|NCT01359852|"~     The purpose of this study is to evaluate [11C] JNJ-42491293 as a PET ligand in healthy adult~     volunteers.~   "
168516|NCT01359839|"~     The goal of this research is to evaluate whether group therapy combining Relaxation Response~     (RR) training and Cognitive Behavioral Therapy (CBT) in a group format merits further~     investigation in the treatment of Major Depressive Disorder (MDD). Specifically, the primary~     aim of this waitlist-controlled study is to gather preliminary data evaluating the~     effectiveness of RR-CBT group as treatment for patients with current MDD or a history of MDD,~     including patients who continue to be depressed despite taking antidepressants and patients~     who choose not to take antidepressants due to the fear of side effects and/or for personal~     reasons.~   "
168517|NCT01359826|"~     Systemic lupus erythematosus (SLE) is a chronic multi-system autoimmune disease impacting the~     physical, social, psychological health and quality of life of patients. Fatigue and pain are~     aspects of SLE patients which affect their health related quality of life (HRQOL). The~     purpose of this study is to determine the effect of milnacipran on fatigue in SLE patients~     with widespread pain (WSP) or fibromyalgia syndrome (FMS). A secondary objective will be to~     determine the effect of milnacipran on pain and quality of life measurements. Fifty SLE male~     and female patients, 18 years and older, will be recruited for a 15-week study, in which~     patients will be receive 14 weeks of milnacipran 50-100 mg twice a day or placebo.~     Measurements of fatigue, pain, and HRQOL will be compared between the milnacipran and placebo~     groups at the screening visit, baseline visit, week number 6, and week number 14. Milnacipran~     has been shown to be an effective treatment for pain, fatigue and physical function in FMS~     patients. To date, no clinical trials have demonstrated efficacy for the treatment of fatigue~     in SLE patients with concomitant WSP or FMS. The investigators hypothesize, based on FMS~     studies, that the milnacipran treated patients will have less fatigue than those in the~     placebo group. In addition, compared to control arm, those treated with the study drug will~     have less pain and improved quality of life.~   "
168629|NCT01358344|"~     The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high~     percentage of drug as the free base are equivalent to tablets with the standard percentage~     when given to participants.~   "
168730|NCT01357031|"~     The purpose of this study is to determine the effectiveness of melatonin 3 mg compared to~     placebo and amitriptyline 25 mg in the preventive treatment of migraine.~   "
168518|NCT01359813|"~     Patients with cirrhosis present an increased susceptibility to bacterial infections.~     Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe~     circulatory dysfunction associated with renal failure in about 30% of cases. Renal failure is~     a reliable surrogate marker of in-hospital mortality in patients with SBP or with non-SBP~     infections. Albumin, as an adjuvant to antibiotherapy reduces significantly the rate of renal~     failure, in-hospital mortality, and overall mortality (Sort P, et al. NEJM 1999). However,~     little is known regarding the effect of albumin administration in patients with non-SBP~     infections. Two recent prospective studies demonstrated that non-SBP infections are~     associated with impairment of the effective circulating volume and precipitate renal failure~     whatever the presence of ascites.~      The aim of this randomized clinical trial is to evaluate the effects of albumin, associated~     with appropriate antibiotic therapy, on occurrence or deterioration of renal failure and~     survival in septic (SIRS criteria required) cirrhotic patients with non-SBP infections and~     presenting with a Child-Pugh score > 8.~   "
168519|NCT01359800|"~     Tat is a key HIV regulatory protein produced very early after infection, prior to virus~     integration, and necessary for viral gene expression, cell-to-cell virus transmission and~     disease progression. Previous studies in natural HIV infection, indicated that the presence~     of a Tat-specific immune response correlates with a lower incidence and reduced risk of~     progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune~     response to Tat may exert a protective role and control the progression to AIDS in vivo.~      On the basis of the above mentioned consideration, the present study was directed at~     investigating the seroprevalence of anti-Tat antibodies in HIV-infected South African~     patients.~   "
168520|NCT01359787|"~     The purpose of this study is to evaluate the efficacy and safety of three concentrations of a~     development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).~   "
168521|NCT01359774|"~     The purpose of this study is to identify and quantify a brain energy deficit in Huntington~     patients, using 31P-RMN spectroscopy.~   "
168522|NCT01359761|"~     This study will implement and empirically evaluate the efficacy of a cognitive behavioral~     intervention program, titled, Post Admission Cognitive Therapy(PACT), for military service~     members and beneficiaries [with Veterans expected to be added] admitted for inpatient care~     due to severe suicide ideation and/or a recent suicide attempt.~   "
168523|NCT01359748|"~     The purpose of this trial is to determine the accuracy of the Blood Pressure (BP) measurement~     of multifunction KEITO devices under test requirements of the Standard American National~     Standards Institute(ANSI)/Association for the Advancement of Medical~     Instrumentation(AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO~     81060-2:2009.~   "
168524|NCT01359735|"~     This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs~     surgery.~   "
168525|NCT01359722|"~     The purpose of this study is to determine the possible effect nephroprotective of~     N-acetylcysteine in patients with chronic kidney disease undergoing elective coronary artery~     bypass grafting by serial evaluation of renal function and to evaluate whether treatment~     reduces cardiac mortality, cardiac events and Global mortality, if it interferes with~     oxidative stress and inflammation and the need for dialysis.~   "
168526|NCT01359709|"~     Cigarette smoking is an important public health concern, and it is most often initiated in~     adolescence. Despite substantial research on smoking cessation in adults, however, relatively~     little effort has focused on therapeutic approaches to reduce adolescent smoking.~      Behavioral interventions, such as contingency management (CM), and pharmacotherapies, such as~     nicotine replacement therapy (NRT), each have some efficacy in reducing adolescent smoking,~     and in adults, combination of behavioral and pharmacological approaches is more effective in~     reducing smoking than either one alone. Little is known about combining these therapeutic~     approaches in adolescent smokers, and research in this area has been hindered, in part, by~     the expense and complexity of large-scale clinical trials of the combined treatments and the~     relative dearth of a cost-effective laboratory procedure. Developing and validating a~     laboratory model to evaluate the combined effects of CM and pharmacological adjuncts for~     adolescent smoking is important because such studies can be conducted more rapidly and~     efficiently, and could provide information on the optimal conditions (e.g., dose) under which~     pharmacotherapies might augment the positive effects of CM.~      The investigators propose to conduct a randomized, placebo-controlled, double-blind,~     between-groups, 2-week laboratory study. Participants will be randomly assigned to one of the~     following four groups: CM+nicotine patches, CM+placebo patches, noncontingent control~     (NC)+nicotine patches and NC+placebo patches. Fifteen participants will be enrolled in each~     of the four groups, totaling 60 participants. On day 1, participants will arrive to the~     laboratory for a 1-h session. During this session, breath carbon monoxide (CO) levels, saliva~     or urinary cotinine levels will be evaluated. Participants will also complete questionnaires~     on craving, withdrawal and cigarette dependence. Participants will then receive seven~     patches, to wear for seven days, one patch daily. Five sessions during the days 8 to 12 will~     serve as CM or noncontingent sessions, and participants will continue wearing patch daily. On~     these sessions, breath CO levels will be evaluated, and participants will have opportunity to~     receive payments based on their CO levels, according to the group assignment. If successful,~     the proposed study will provide a human laboratory model for use in studies of the combined~     CM and pharmacological approaches for modifying adolescent smoking behavior.~   "
168527|NCT01359696|"~     This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety,~     tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with~     and without gemcitabine.~   "
168528|NCT01359683|"~     The purpose of this study is to investigate non-linear heart rate variability indexes as~     predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery,~     including coronary artery bypass graft (CABG) and valvular surgery.~   "
168529|NCT01359670|"~     This study, supported by Parent Project Muscular Dystrophy, will determine if tadalafil or~     sildenafil can improve muscle blood flow during exercise in boys with Duchenne muscular~     dystrophy.~   "
168530|NCT01359657|"~     The purpose of this study is to determine 1) the safety and tolerability of multiple~     intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the~     maximum tolerated dose (MTD) of BMS-936564 in combination with Lenalidomide/Dexamethasone or~     Bortezomib/Dexamethasone in subjects with relapsed or refractory multiple myeloma.~   "
168531|NCT01359644|"~     The purpose of the study is to determine whether therapy with the combination of PSI-7977 and~     daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus~     (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response~     with undetectable HCV RNA 12 weeks post treatment~   "
168532|NCT01359631|"~     Hypothesis:~      Stimulation of the SPG at high frequencies (50-200Hz) is believed to cause a physiological~     parasympathetic block which decreases VMCA oxyHb concentration and cephalic vessel diameter.~      Stimulation of the SPG at low frequencies (1-60 Hz)is believed to cause a physiological~     parasympathetic upregulation which increases VMCA, oxyHb concentration and cephalic vessel~     diameter.~   "
168533|NCT01359618|"~     This is a two part study. Part A will determine the maximum tolerated dose of TC-5214~     administered to healthy male subjects in single ascending oral doses. This part of the study~     will define the highest dose of TC-5214 to be administered in Part B. Part B of this study~     will investigate the effect of TC-5214 on the electrical activity of the heart following~     single oral administration. The study will be carried out healthy male subjects in a four~     period crossover study with TC-5214 compared to placebo and oral moxifloxacin as a positive~     control. The safety, tolerability and pharmacokinetics of TC-5214 will also be evaluated.~   "
168534|NCT01359605|"~     The purpose of the study is to characterize the metabolism and excretion (ADME) of a single~     oral dose of [14C]varespladib methyl.~   "
168535|NCT01359592|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride,~     vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by~     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer~     growth in different ways. Some block the ability of cancer cells to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled~     monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and~     carry cancer-killing substances to them without harming normal cells. Comparing results of~     diagnostic procedures, such as PET scan and CT scan, done before, during, and after~     chemotherapy may help doctors predict a patient's response to treatment and help plan the~     best treatment.~      PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating~     patients with limited-stage diffuse large B-cell lymphoma.~   "
168536|NCT01359579|"~     The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and~     the safety of varespladib methyl in mild or moderate renal impairment patients and healthy~     volunteers.~   "
168537|NCT01359566|"~     To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo~     for the treatment of spasticity in subjects with multiple sclerosis (MS).~   "
168538|NCT01359553|"~     The purpose of this study is to clarify the potential of intra-articular ultrasound imaging,~     non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and~     arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and~     compared with the arthroscopic findings.~   "
168539|NCT01359540|"~     This study compares the change in bone density which occurs after hip replacement with~     different femoral stem devices.~   "
168540|NCT01359527|"~     This study compares the change (loss) of bone mineral density (BMD) that occurs in the~     proximal femur after hip resurfacing and total hip replacement.~   "
168541|NCT01359514|"~     Mechanism-based choice of therapy for neuropathic pain:~      Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain~     modulation profile?~   "
168542|NCT01359501|"~     This is a two-year double blind, placebo-controlled, and randomized clinical trial, which is~     aimed to evaluate the effects of Chinese medical treatment on leucopenia after chemotherapy~     in breast cancer patients.~   "
168543|NCT01359488|"~     The purpose of this research study is to determine the safety and tolerability of up to five~     doses of VRS-317 in Adult Growth Hormone Deficient patients.~        -  Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes~          from baseline in insulin-like growth factor-1 (IGF-I) and binding protein (IGFBP-3), and~          bone turnover (bone alkaline phosphatase)~        -  Descriptive pharmacokinetic (PK) and pharmacodynamic (PD) parameters (IGF-I and IGFBP-3)~          will be determined by standard model independent methods based on the plasma~          concentration-time data of each subject. These parameters include: Cmax, Tmax, AUCavg,~          AUC0-inf, and t1/2.~        -  The purpose is to determine the appropriate dose of VRS-317 to maintain a normal range~          (for appropriate age/gender) for IGF-I levels in adult patients for up to one month~          after administration of a single dose~   "
168544|NCT01359475|"~     Preformed stainless steel crowns have been used in Pediatric Dentistry to restore badly~     broken down primary teeth since 1950. They are generally considered more expedient to place~     than large multi-surface amalgam or composite restorations and have a longer life. They have~     been used successfully in clinical practice for many years and have presented little in the~     way of adverse events. The major drawback is the poor esthetics along with lingering concerns~     over potential health hazards associated with the nickel content. Several attempts have been~     made to improve upon the esthetics of stainless steel crowns such as veneering the buccal and~     occlusal surfaces and substituting composite resin for the entire crown, but to date none of~     these approaches have been very successful.~      Acetal resin has been used in a number of applications in medicine and dentistry, and~     recently has met with early success when tested as a substitute for stainless steel crowns.~     It has a number of excellent physical and mechanical properties including a low coefficient~     of friction, good wear resistance, high fatigue resistance, good impact strength and~     resistance to creep.~      The purpose of this trial is to compare the clinical performance of preformed acetal resin~     crowns and preformed stainless steel crowns.~      2.0 OBJECTIVES~      The objective of this study is to compare the clinical performance of acetal resin crowns~     with preformed stainless steel crowns when used to restore primary molar teeth.~   "
168545|NCT01359462|"~     For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics,~     pharmacology, and safety of the drug under fasting condition.~   "
168546|NCT01359449|"~     The purpose for this study is to demonstrate the safety and immunogenicity of two doses of~     Menactra® administered between 12 and 18 months of age and concomitantly with routine~     immunization with two different provincial schedule~      Primary Objectives:~        -  To describe the immunogenicity of Menactra® administered concomitantly with routine~          immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants~          (measured by serum bactericidal assay using baby rabbit complement [SBA-BR])~        -  To describe the immunogenicity of MenC administered concomitantly with routine~          immunizations at 12 months of age (measured by SBA-BR)~      Secondary Objectives:~      Safety~        -  To describe the safety profile of Menactra® and MenC vaccines after each dose when given~          concomitantly with routine immunization.~      Immunogenicity~        -  To describe the immunogenicity of both vaccines using serum bactericidal assay using~          human complement [SBA-HC]~        -  To describe the immunogenicity of Pediacel administered at 18 months.~   "
168547|NCT01359436|"~     The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor~     for specific EGFR mutation detection in clinical specimens of NSCLC patients, the~     investigators conduct a prospective clinical study. In comparison with results from direct~     sequencing of EGFR, the investigators evaluate the performance of e- Ab sensor, including~     reproducibility, sensitivity, specificity, and cross-reaction (such as detection of EGFR~     mutations other than L858R and DelL746-A750). The potential factors which may interfere with~     the results would be investigated. With such technique, the investigators can obtain EGFR~     mutation information of NSCLC patients in cost-saving and time-saving way and can offer more~     individualized treatment for the investigators patients.~   "
168548|NCT01359423|"~     Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in~     the treatment of long (≥80 mm) femoropopliteal artery lesions.~      Study design :~        -  Prospective, randomized, multi-center study~        -  A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who~          meet all inclusion and exclusion criteria will be included.~        -  Patients will be randomized in a two by two factorial manner according to the strategy~          of stenting (long versus short stenting) and the additional use of cilostazol. Each~          randomization of the enrolled subjects will be done 1:1.~        -  Patients will be followed clinically for 1 year after the procedure.~        -  Angiographic or CT follow-up will be performed at 1 year.~   "
168549|NCT01359410|"~     The investigators propose a randomized, controlled trial of stapled pancreatic transection~     versus mesh reinforced stapled pancreatic transection. For the duration of the study period,~     participating surgeons will utilize a standardized staple technique. Either a reabsorbable~     polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium~     (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the~     test group. In order to have a uniform test method, the investigators will utilize a~     laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple~     size (4.8mm).~   "
168550|NCT01359397|"~     Background: It is estimated that in the Netherlands each year approximately 900 patients with~     gastric cancer or adenocarcinoma of the gastro-oesophageal junction are candidates for~     chemotherapy. Randomized studies comparing chemotherapy versus best supportive care have~     shown that survival and quality of life are prolonged with chemotherapy. However, no~     chemotherapy regimen is clearly superior with regard to prolongation of survival. Therefore,~     tolerability of treatment and ease of administration (outpatient compared to inpatient) are~     important considerations for the development of novel treatment schedules. Study design: This~     is an open-label, multicentre, phase II trial designed to evaluate the efficacy and safety of~     bevacizumab in combination with docetaxel, oxaliplatin and capecitabine chemotherapy (B-DOC)~     as first-line therapy in patients with inoperable locally advanced or recurrent and/or~     metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. In case of HER2~     positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the~     stomach or gastro-oesophageal junction trastuzumab is added to this regimen (B-DOCT).~      Study Endpoints:~      Primary endpoint Progression free survival defined as the time measured from B-DOCT study,~     Protocol version 3.0 dated January 18, 2011 Page 5 / 60 the day of registration to first~     progression or death. Secondary endpoints Toxicity Overall survival, defined as the time from~     registration to death Response rate defined as the percentage of partial and complete~     responses Duration of response defined as time from response to first progression~     Translational research on pharmacogenomic and biological factors that may predict treatment~     response.~   "
168551|NCT01359384|"~     The purpose of the clinical trial is to gain a more substantial understanding of bronchial~     inflammation in patients with severe primary immundeficiency under immunoglobulin therapy. It~     is intended to characterize the systemical such as the bronchial inflammation (IL-1, IL-2,~     IL-6, IL-8, IL-17, TNF-a, NFkB, IFN-gamma, TGF-beta, TLR2 und TLR4)in children with severe~     immune deficiency in order to generate new treatment strategies based on the results.~      The methods being used for characterization purposes within this trial include specific lung~     function tests ( spirography, bodyplethysmographie w. helium) such as the analysis of eNO and~     eCO. Furthermore, sputum and serum samples are being analyzed by quantitative real-time~     polymerase chain reaction (PCR),(qRT-PCR) and by cytometric bead assay (CBA). Components of~     the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant~     proteins) are genetically determined from sputum or blood respectively. In the conduct of the~     study the investigators will retrospectively and systematically evaluate the available~     high-resolution computed tomography (HRCT) studies of affected patients.~   "
168552|NCT01359371|"~     The purpose of this study is to evaluate the peer telephone cessation counseling that has~     been and continues to be implemented at the Ann Arbor VA as part of the Tobacco Tactics~     intervention.~   "
168553|NCT01359358|"~     This project has as general objective to determine if there is any Methicillin-resistant~     Staphylococcus aureus (MRSA) strain disseminating in the hospital of Belo Horizonte. If this~     is the case, the investigators will determine if this is an international known strain by~     typing it by PFGE and MLST.~      The detection of mecA gene will be performed by PCR. Their susceptibility profile to several~     drugs will also be accessed and it will be possible to compare the response to those drugs~     commonly in use to that of Daptomycin, a new drug available in Brazil.~      It will be screened for reduced susceptibility to vancomycin by Macromethod Etest (MET) in~     order to search for VISA or hetero-VISA. Also, due to the discussions at the literature about~     mutations in genes that are said to be responsible for reduced susceptibility to vancomycin,~     the investigators will sequence these genes in all PFGE type strain of this study looking for~     mutations already described to compare to the screening results.~   "
168554|NCT01359345|"~     Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with~     severe renal failure mainly in patients under dialysis in whom gadollinum is being used.~      The investigators will evaluate the prevalence and severity of NSF in patients with different~     degree of renal failure whom underwent imaging with Gadolinum.~   "
168644|NCT01358149|"~     Today, there is an important lack of knowledge on child metabolism and the effects of~     phytochemical-rich foods, which includes fruits and vegetables and plant-derived foods. Here,~     the investigators will monitor the metabolism of children using minimally invasive techniques~     at rest, and with physical/mental activities and assess the changes associated with the~     intake of cocoa-based food.~   "
168555|NCT01359332|"~     Status EPILEPTICUS (SE) is a major medical emergency. The incidence per 100,000 population~     has been estimated at 9.9 episodes in Europe and 41 episodes in the US. The overall morbidity~     and mortality associated with convulsive SE (CSE) is 60% at three months. The alteration of~     functional prognosis of these patients is more conventionally attributed to the cause than to~     CSE itself. Longer seizure duration, progression to refractory status EPILEPTICUS and~     presence of cerebral insult are strong factors independently associated with a poor~     functional outcome. These three factors offer may be amenable to improvement and hope for~     preventive strategies. Current guidelines recommend the use of anticonvulsant treatment whose~     goal is prompt cessation of clinical and electrical seizures. None of these treatments has~     demonstrated NEUROPROTECTICE property. Therapeutic moderate hypothermia (between 32 and 34 °~     C) showed interest in neuroprotection of post anoxic coma patients after a cardiovascular~     arrest on ventricular fibrillation by reducing morbidity and mortality in about 20% without~     major side effects. This technique has been used successfully in various pathologies such as~     stroke or traumatic brain injury. Pathophysiological mechanisms involved in epileptogenesis~     and neurotoxicity induced by persistence of seizures can be blocked by therapeutic~     hypothermia. Recent work on experimental models of SE demonstrated neuroprotective and~     anticonvulsant interest of therapeutic hypothermia. Therapeutic hypothermia has also been~     successfully used in some cases of particularly refractory CSE. Its early use in patients~     with SE would have a double interest: neuroprotective and anticonvulsant. There is currently~     no published studies or ongoing to determine the interest of its early use in patients with~     CSE.~   "
168556|NCT01359319|"~     Hereditary Inclusion Body Myopathy (HIBM) is a severe progressive metabolic myopathy caused~     by a defect in the biosynthetic pathway for sialic acid (SA), a critical component of many~     muscle proteins, resulting in a deficiency in SA in the muscles of HIBM patients.~      The effective replacement of the missing SA substrate is theoretically simple, and, in animal~     models, replacement with SA showed significant restoration of sialylation biochemistry and~     excellent reduction in muscle disease. These data show that replacement can achieve~     significant clinical benefit in muscle pathology, function, and survival.~   "
168557|NCT01359306|"~     The purpose of this study is to determine the predictors of right ventricular damage (RVD)~     assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement~     (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI)~     and its prognostic significance.~      The investigators hypothesize that ischemia related changes of the myocardium are also~     visible in the right ventricle and that they have an impact on patient outcome.~   "
168558|NCT01359280|"~     Persistent adherence to antiretroviral therapy is necessary for the successful treatment of~     HIV infection. The proposed research will test a theory-based behavioral intervention that~     includes objectively monitoring HIV treatment adherence with corrective feedback delivered by~     cell phone. The study will also test the independent effects of an automated text message~     reminder system for sustaining adherence improvements. The intervention under study has~     utility for people living with HIV/AIDS In resource limited rural and urban settings.~   "
168559|NCT01359267|"~     The purpose of this study is to obtain preliminary information on the potential of 99m~     Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.~   "
168560|NCT01359254|"~     The primary objective of this study is to assess the rate of engraftment with combined~     haploidentical-cord blood transplantation in patients with pre-existing donor specific~     antibodies and in those with active disease.~   "
168561|NCT01359241|"~     The main objective of this study is to evaluate the efficacy and safety of 24 hours of~     closed-loop glucose control compared with standard diabetes treatment, in patients with type~     2 diabetes treated by non-insulin glucose-lowering medications. This group is being studied~     as it is representative of patients with glucose dysregulation.~   "
168562|NCT01359228|"~     The purpose of this study is to determine the effects of rifaximin on skin symptoms in~     patients with rosacea by double-blinded, placebo-controlled, crossover study.~   "
168563|NCT01359215|"~     The purpose of this study is to determine whether pediatric anesthesia is associated with~     long-term hippocampal dysfunction~   "
168564|NCT01359202|"~     This clinical trial will enroll 110 patients from approximately 15 Canadian stroke centres.~     Patients coming to the emergency department with bleeding in the brain not due to trauma or~     other known causes who can be treated within 6 hours of onset will undergo CT angiography~     using standard CT scanners (CAT scan). Those with a spot sign, a type of marker on the CT~     scan that shows the brain is still bleeding, will be randomly assigned to a single injection~     of factor 7(a blood clotting drug used in hemophilia) or placebo (inactive saline);~     patients without a spot sign will not be treated. The researchers will look at how much~     bleeding happens after the treatments are administered, as well as clinical outcomes such as~     death and disability. The researchers think that factor 7 will cause the bleeding to stop~     faster and possibly decrease death and disability.~   "
168565|NCT01359189|"~     This is a feasibility, exploratory, and proof-of-concept study to evaluate rectal probe~     scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent~     (ProstaScint®) in patients with suspected primary prostate cancer. ProxiScanTM is a small~     cadmium zinc telluride (CST)-based compact gamma camera the size of a trans-rectal ultrasound~     (TRUS) developed by Hybridyne Imaging Technologies, Inc.To explore the adjunctive~     benefit/feasibility of PSMA distribution in the normal prostate versus prostate cancer gland~     utilizing TRUS and CT/SPECT hybrid imaging, biopsy negative patients will be considered as~     normal controls. Prostate cancer sextant biopsy histology results will be correlated with~     ProxiScanTM, TRUS, and pelvis planar and SPECT/CT. Our hypothesis is that it will be safe and~     feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific~     ProstaScint® uptake in primary prostate cancer.~   "
168566|NCT01359176|"~     Capnography is the non-invasive monitoring of the concentration or partial pressure of carbon~     dioxide (CO2) in the expired respiratory gases; it is thus a non-invasive monitoring~     technique which allows fast and reliable insight into ventilation, circulation and~     metabolism. The capnogram is a direct monitor of the inhaled and exhaled concentration or~     partial pressure of CO2, and an indirect monitor of the CO2 partial pressure in the arterial~     blood. The purpose of this study is to create a waveform library by collecting CO2 waveform~     data from healthy volunteers.~   "
168570|NCT01359124|"~     The primary objective is to evaluate water based treadmill exercise, land based treadmill~     exercise, and upright cycling in meeting American College of Sports Medicine exercise goals~     for moderate exercise.~      The secondary objective is to compare exercise tolerance for water based treadmill, land~     based treadmill, and upright cycling in meeting American College of Sports Medicine exercise~     goals for moderate exercise.~      The tertiary objective is to evaluate quality of life improvements for water based treadmill~     exercise, land based treadmill exercise, and upright cycling.~   "
168571|NCT01359111|"~     The purpose of this study is to evaluate whether an investigational vaccine delivery device~     (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the~     skin.~   "
168572|NCT01359098|"~     The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3%~     Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of~     Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7~     days.~   "
168573|NCT01359085|"~     Arthroscopic rotator cuff (RC) repair is often associated with severe post operative pain and~     discomfort. Many analgesic protocols have been proposed for pain relief following RC repair~     and controversy remains regarding the optimal postoperative analgesic protocol. Despite~     significant advancement in analgesic techniques over the last decades 50-70% of patients who~     undergo surgical procedures still experience moderate to severe postoperative pain.~     Postoperative pain has both inflammatory component (i.e. related to traumatic tissue damage~     and inflammatory reaction due to the surgical incision and procedure) and neuropathic~     component (i.e. related to over sensitization of the peripheral and central nervous system).~     Opioids are commonly used for postoperative pain reduction, however their use is associated~     with numerous adverse events and should be limited.~      Regional nerve block techniques have been emerged over the past decade and have become a~     standard of practice recently. Recent studies indicate that a single-dose interscalene~     brachial plexus block (ISBPB) is effective in providing postoperative analgesia following~     shoulder surgery, reduces the need for opioid medication, and has a very high success rates~     (≥94%) and few major complications (≤0.4%). However, regional nerve blockade, including~     ISBPS, has a frequent incidence of temporary postoperative neurological symptoms within the~     first postoperative week (4 -16%), is technically demanding and might be time consuming.~      Pregabalin (Lyrica) is an anticonvulsant drug with membrane stabilizing and anti-nociceptive~     effects commonly used for neuropathic pain relief and anxiety disorder. It desensitizes the~     presynaptic terminals of hyperexcited neurons in peripheral and central nervous system (i.e.~     reduces the transmission of excitatory neurotransmitters including glutamate, norepinephrine,~     substance P, and calcitonin gene-related peptide) by reducing calcium influx through~     high-voltage-activated calcium channels containing the alpha2/delta subunit. Pregabalin is~     rapidly absorbed from the gut with bioavailability of approximately 90%, achieves peak plasma~     concentration approximately 1h after administration, has half-life of about 6h and is~     eliminated by renal excretion. Many studies over the past decade have evaluated pregabalin~     roll in the treatment of acute postoperative pain. Pregabalin effect in reducing opioid~     consumption and opioid adverse events (AEs) has been well established. Its analgesic effect~     on acute postoperative pain remains questionable, and further studies are still required to~     compare pregabalin analgesic potential with other standard post-operative analgesic regimens.~     Pregabalin doses used in previous studies ranged from 75 to 600 mg given as a single dose~     1-2h preoperatively with or without additional doses at 12h and 24h postoperatively. Doses of~     150 mg and higher seemed to offer better results in terms of postoperative analgesia and~     opioids sparing. However higher doses were associated with higher rate of AEs, mainly~     sedation, dizziness and visual disturbances.~      Nervous system desensitization by oral medication (e.g. pregabalin) rather than by invasive~     means (e.g. ISBPB) may reduce adverse reactions, increase patient satisfaction and save~     valuable time in the operation theater. To the investigators knowledge no previous study has~     compared the efficacy of pregabalin to ISBPB for acute pain relief following arthroscopic~     shoulder surgery. The investigators hope to contribute to the discussion regarding the~     optimal pain relief method following arthroscopic shoulder surgery.~   "
168574|NCT01359072|"~     -  Approximately 30% of all patients with cancer report levels of psychological distress~          indicative of the need for psychological intervention.~        -  Research suggests that learning more adaptive coping strategies improves psychological~          adjustment to cancer.~        -  It is imperative to develop cost-efficient, feasible psychosocial interventions.~        -  The aim is to test the efficacy of the self administered format of a psycho-educational~          intervention (NUCARE) in reducing distress and enhancing adaptive coping strategies for~          cancer patients.~      It is hypothesized that:~        -  patients would show significant reductions in distress (i.e., depression and anxiety)~          over the 6-week treatment period, and that treatment would produce superior results~          compared to wait-list; patients would maintain or even increase their improvement up to~          3 months following treatment.~        -  the treatment would enhance more adaptive coping strategies.~        -  greater self-reported adherence to the treatment/homework would be associated with~          symptom improvement, more autonomous self-regulation and higher perceived competence for~          adhering to the coping intervention program.~   "
168575|NCT01359059|"~     Hypothesis~      No studies considered the comparison of preemptive vs. post-surgery Pregabalin (PGL) only~     administration. The investigators believe that the administration of PGL preemptively would~     diminish pain sensation and therefore the need for opioids administration in~     orthopedic-oncologic patients more effectively than if administered starting postoperatively.~   "
168576|NCT01359046|"~     Urinary catheters are used routinely in the postoperative care of urogynecology patients~     after surgery involving the genitourinary tract. However, Urinary tract infections(UTI)~     associated with indwelling catheter is the second leading cause of nosocomial infections. 20%~     of hospital acquired bacteremia arise from UTI with an associated mortality of 10%.~      There are many different types of catheters available for use. Standard indwelling catheters~     are made from a variety of materials including polyvinyl chlorine, plastic, plain latex,~     polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer.~     Specialized catheters have been developed with the aim of reducing infection. Strategies~     generally involved coating the inner, outer or both surfaces of the catheter with~     antimicrobial materials. These materials can be antibiotic or antiseptic with the most common~     antiseptic material used being silver. Silver ions are bactericidal, are used safely when~     applied topically to humans and used in controlling infections.~      Previous studies comparing UTI rates in transurethral catheters have reported a significant~     reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard~     catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy~     supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that~     this study will show a statistically significant decrease in UTI rate among the individuals~     with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.~   "
168577|NCT01359033|"~     The study aims to investigate the differences in survival trajectories and hospital~     variability in myocardial infarction (MI) mortality rates in the UK and Sweden.~   "
168578|NCT01359020|"~     The purpose of this study was to compare the efficacy and tolerability of acetaminophen,~     dipyrone and ibuprofen to fever control in children.~      For the efficacy asses were compared:~        -  the time to start the action;~        -  the action duration;~        -  the difference between the basal temperature and the lower temperature in the study~          period.~      For the tolerability asses all adverse events were recorded, as well as your intensity and~     the relation to the treatment.~   "
168579|NCT01359007|"~     The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and~     the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging~     sufficient to allow surgical resection, could improve the overall survival of patients with~     locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic~     cancer, a phase II study of this regimen in patients with locally advanced unresectable and~     borderline pancreatic cancer is planned to determine the rate of conversion to operability.~   "
168580|NCT01358994|"~     From a central registry at the National Board of Health and Welfare in Sweden collect all~     patients in the city of Malmö prescribed metformin during two years. Glomerular filtration~     rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control~     material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU~     admission were also sought. The study hypothesis is that metformin is prescribed to patients~     with lower GFR than anticipated with very few cases of lactic acidosis registered.~   "
168581|NCT01358981|"~     This will be the first study in which LY2881835 is given to humans in order to evaluate the~     safety and any side effects of LY2881835 in humans as well as how long LY2881835 stays in the~     body and its effect on blood sugar levels.~      The study consists of two parts. In part A, healthy subjects will participate and in part B,~     patients with type 2 Diabetes Mellitus (T2DM) will participate.~   "
168657|NCT01357980|"~     The purpose of this study is to determine the efficacy and safety of a single dose of 750 U~     of Dysport compared to placebo for the improvement in the daily incontinence episode~     frequency for each administration mode in subjects suffering from neurogenic detrusor~     overactivity following spinal cord injury or multiple sclerosis.~   "
168749|NCT01356784|"~     TEst the effect of Tailored Physical Activity or Chronic Pain Self-management Program on~     Returning to Work in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body~   "
168582|NCT01358968|"~     The purpose of this study is to assess the effect LY2603618 on a protein (enzyme CYP2D6)~     which is involved in the metabolic pathway of Desipramine in patients with cancer. This is a~     drug interaction study so the treatment of the disease will not be the main purpose of the~     study.~      The study involves two single doses of 50mg, 1 tablet by mouth, on Day 1 of Period 1 and 2.~     In Period 1 Desipramine will be administered alone, In Period 2 Desipramine will be~     administered in combination with LY2603618. LY2603618 will be administered as a 275mg IV~     infusion over 1hr.~      Desipramine will be administered at the end of the LY2603618 infusion. Information about any~     side effects that may occur will also be collected.~   "
168583|NCT01358955|"~     -  There will be a significant difference in cognitive function between cognitive~          intervention group (group therapy) and a wait list control group.~        -  There will be a significant difference in cognitive function between a home-based~          cognitive intervention group and a wait list control group.~   "
168584|NCT01358942|"~     This prospective observational study will evaluate the evolution of lung cancer related~     symptoms and their correlation with the disease control rate (complete response, partial~     response and stable disease) in patients with non-small cell lung cancer initiating~     first-line treatment with standard platinum-based chemotherapy with or without Avastin~     (bevacizumab). Data will be collected from each patient at baseline and after 4-6 cycles of~     chemotherapy.~   "
168585|NCT01358929|"~     This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive~     multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8~     weeks.~   "
168586|NCT01358916|"~     Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a~     major driving force for the development of resistance. Thus optimization of antibiotic~     prescription and reduction of unnecessary antimicrobial treatment are essential in the~     prevention and reduction of antimicrobial resistance rates.~      The goal of this study is the improvement of antibiotic prescription in outpatient care. The~     study will take place within a Swiss-wide sentinel surveillance network of physicians. The~     participating physicians will be randomised in a control and intervention group. The~     intervention group will receive therapeutic guidelines for the treatment of upper and lower~     respiratory tract infections and lower urinary tract infection as well as regular feed-backs~     on the prescription pattern of the sentinel physicians during the past months. Sentinel~     physicians will collect information about each antibiotic prescription, its indication and~     characteristics of the patient.~      Our hypothesis is that the prescription pattern in the intervention group will be optimised~     and unnecessary antibiotic therapy will be reduced compared to the control group.~   "
168587|NCT01358903|"~     This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and~     efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing~     malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously~     at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1~     and/or 2, followed by RO5429083. For all patients there will be an option to continue~     treatment with RO5429083 until disease progression or unacceptable toxicity occurs.~   "
168588|NCT01358890|"~     -  The primary aim of this study is to determine the adherence of low- carbohydrate among~          Chinese.~        -  Then compare the effect of low-carbohydrate and traditional Chinese but~          restricted-calories diet on weight loss and metabolic traits.~   "
168589|NCT01358877|"~     This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and~     efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in~     participants with operable HER2-positive primary breast cancer. This study will be carried~     out in collaboration with the Breast International Group (BIG).~   "
168590|NCT01358864|"~     The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or~     24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in~     chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.~   "
168591|NCT01358851|"~     The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to~     cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch~     biopsies).~   "
168592|NCT01358838|"~     Rationale: Scars can be highly disfiguring and may result in functional impairment and~     psychosocial problems. Recently, fractional laser therapy (FLT) has been introduced as a~     promising novel treatment modality for scars.~      Objectives: The primary objective of this study is to assess the efficacy and safety of 10600~     nm FLT for the treatment of different types of scars.~      Study design: Prospective observer blinded randomised controlled split-lesion trial.~      Study population: Thirty consecutive patients, aged at least 18 years, with hypertrophic or~     atrophic scars who give written informed consent.~      Methods: Two similar test regions of the scar will be randomly allocated to either 3 sessions~     of FLT (UltraPulse Encore 10600 nm Total FX) with an interval of 4 weeks or no treatment.~      Main study parameters/endpoints: Blinded Physicians Global Assessment is the main outcome~     variable. Secondary variables are Patient's Global Assessment, blinded clinical assessment of~     the scar on a scale from 0-3 (erythema, pigmentation, texture, hypertrophy, atrophy,~     pliability), Patient and Observer Scar Scale (POSAS), objective colour measurements by~     reflectance spectroscopy (LAB) and chromameter (erythema index, melanin index).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Subjects participating in the study will be requested to visit the SNIP~     (Amsterdam) 3 times for treatment and 2 times for follow-up. The time investment per visit~     will be 30 minutes for treatment sessions and 20 minutes for follow-up visits. FLT using a~     10600 nm laser device is a minimally invasive laser procedure with FDA approval for both the~     device (Lumenis Encore 10600 nm) and the indication (scar). Local side effects are erythema~     (always; 1-2 weeks), oozing (often; 1-3 days), swelling (always, 1-4 days), blisters < 0.5cm~     (occasionally) and blisters > 0.5cm (very rare). No systemic side effects are known for this~     laser device.~      All outcome measures involve non-invasive procedures. The laser treatment (FLT) requires~     local anesthesia. The amount of topical anesthetic used for infiltration is low~     (approximately 5% of the maximum dose) which minimizes the risk for local or systemic side~     effects due to the anesthetic agent.~      All together the burden due to the study is moderate, side effects are generally local and~     mild. Systemic side effects are not reported with this treatment. There is an indirect~     benefit for the participating subject. In case of improvement of the treated test regions,~     this therapy can be directly utilized to treat the whole scar.~      Considering the relative lack of alternative treatment options in many of these scars, the~     balance between burden, possible side effects and prospect for improvement is very favorable.~   "
168593|NCT01358825|"~     The aim of this study is to assess antibody persistence in infants who received three doses~     of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11~     months of age in study NCT00307034.~   "
168697|NCT01357460|"~     Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might~     benefit from endoscopic implantation of intrabronchial valves.~   "
168594|NCT01358812|"~     The GONO-FOLFOXIRI regimen demonstrated higher activity and efficacy compared to FOLFIRI in a~     phase III trial. Panitumumab with oxaliplatin- or irinotecan-based doublets is feasible and~     associated with improved activity in KRAS codon 12-13 wild-type patients. BRAF and other RAS~     rare mutations have been suggested as additional potential biomarkers for anti-EGFR agents in~     metastatic colo-rectal cancer. The present study aims to demonstrate the feasibility and the~     activity of the first-line combination of the GONO-FOLFOXIRI regimen and Panitumumab in~     molecularly selected metastatic colo-rectal cancer patients.~   "
168595|NCT01358799|"~     The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay~     for Chlamydia trachomatis (CT; ACT Assay), which is cleared for use on the TIGRIS DTS~     (Direct Transfer) System (TIGRIS System), can be tested on the PANTHER System. The intended~     use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER~     System. ACT Assay performance on the PANTHER System is comparable to performance on the~     TIGRIS System.~   "
168596|NCT01358786|"~     Patient undergoing breast reconstruction with lower abdominal flap, benefit when points are~     used for membership (between the aponeurosis of the abdominal flap and underlying muscles)~     for closing the donor area, where there is reduced incidence of complications.~   "
168597|NCT01358773|"~     Obese adolescents are submitted to a multiprofessional weight loss program, which is formed~     by doctors, nutritionists, physiotherapists, psychologists,and physiologists. The volunteers~     have intervention 3 times a week during one year, where they practice exercises, have~     nutrition and psychology counseling, and physiotherapy orientation. Once a month they have an~     appointment with the doctor. The hypothesis of this study is that a multiprofessional therapy~     is able to improve anthropometric and biochemical parameters, and also the quality of life of~     obese adolescents.~   "
168598|NCT01358760|"~     The purpose of this Phase III trial is to evaluate the efficacy of intravaginal~     dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.~   "
168599|NCT01358747|"~     All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is~     hoped that patients will achieve a good response to both induction therapies consisting~     either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide,~     Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD~     (Adriamycine, Bléomycine, Vinblastine, Décarbazine).~      The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2)~     in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc~     therapy continuation to those patients who achieved only a partial response after 2~     BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2~     negative patients. For all patients included in the trial the achievement of a good response~     to induction treatment will be checked after four cycles of induction treatment including a~     centrally reviewed PET assessment~      Patients will be randomized after verification of eligibility and before the start of the~     protocol treatment.Patients will be randomly assigned to the standard treatment arm not~     monitored by early PET, or the experimental treatment arm driven by the PET2 result.~   "
168600|NCT01358734|"~     The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential~     azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed~     acute myeloid leukemia (AML).~   "
168601|NCT01358721|"~     The purpose of this study is to evaluate the pharmacodynamic and biologic properties of~     BMS-936558 in subjects with metastatic renal cell carcinoma.~   "
168602|NCT01358708|"~     Irritable bowel syndrome is a complex condition with a high unmet medical need for effective~     and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and~     symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a~     potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).~   "
168603|NCT01358695|"~     The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of~     ANT-1207 in the treatment of Crow's Feet.~   "
168604|NCT01358669|"~     Although hip replacement surgery is a successful way of dealing with the pain and immobility~     caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10~     years. The main reason for this is the development periprosthetic osteolysis, that is, loss~     of bone around the site of the hip replacement. The osteolysis is thought to be due to the~     small particles of debris worn from the surfaces of the hip implant. These particles cause a~     reaction in the blood cells around the joint which in turn affects bone cells and leads to a~     loss of bone around the implant. The joint implant will then eventually become loose and~     unstable, a condition known as aseptic loosening. At present the only way to treat aseptic~     loosening is to have another operation to secure the hip joint, known as revision surgery.~     Revision surgery is not always successful and exposes the patient to the risk of major~     surgery.~      In this study we explore the potential for giving a medication (denosumab) that may prevent~     the loss of bone around the hip replacement implant. We will recruit patients who have been~     listed for revision surgery. One group of patients will be given a single dose of denosumab;~     another group will be given a placebo (dummy drug). At the time of the revision surgery a~     small sample of the bone from around the hip replacement will be taken and examined under the~     microscope. Comparisons will be made between the patients having the denosumab and those~     having placebo to find out whether the denosumab is having a beneficial effect on the bone~     surfaces. If successful, this study will lead to further studies to develop the use of~     denosumab to prevent aseptic loosening.~   "
168605|NCT01358656|"~     Anterior Cruciate Ligament (ACL) reconstruction surgery has greatly advanced over the last 20~     years. However, data in the literature reveal that approximately 15-25% of patients~     undergoing surgery still do not present optimal outcomes, which suggests that there is room~     for improvement of the procedure. A possible explanation for this fact is that most ACL~     reconstructions consider only one of the functional bundles of the ligament. Our hypothesis~     is that the ACL reconstruction with the double-bundle technique will be effective in reducing~     the patients' rotation of the knee joint for high-demanding tasks compared to the patients~     who had ACL reconstruction with the single-bundle technique.~   "
168764|NCT01356589|"~     This retrospective observational study will assess the incidence of hemoglobin cycling in~     chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera~     (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a~     9-month treatment period.~   "
168606|NCT01358643|"~     The purpose of this pilot is to assess the feasibility and potential effectiveness of three~     specific e-health approaches. One approach, SparkPeople.com, involves the use of social media~     and can be accessed through a free website. This approach has the potential to provide~     support through an on-line community as well as a number of diet/weight and physical activity~     related tools. A mobile phone application is also available for those with smart phones. The~     second approach, BodyMedia, involves the use of an objective monitoring device that tracks~     all activity. This information can be uploaded to a website to provide ongoing monitoring and~     feedback about activity and energy expenditure. The third approach, P90X, involves a DVD~     based resistance focused exercise program. While DVD programs are not necessarily considered~     e-health, participants will be encouraged to participate in online community forums~     associated with the program. All participants, regardless of randomization, will be given 4~     point of decision prompts that are laminated 8.5x11 posters encouraging healthier behaviors~     to display in various areas of their home.~      The specific aims are:~        1. To assess the effect of the intervention on weight, activity levels, depression, and~          adherence.~        2. To determine level of interest, perceptions, feasibility and satisfaction of the~          proposed interventions (i.e. SparkPeople.com vs. BodyMedia vs. P90X) with particular~          attention to: 1) social media; 2) food logs; 3) objective monitoring of physical~          activity; 4) use of point systems~   "
168607|NCT01358630|"~     The purpose of this study is to analyze genetic polymorphisms in genes encoding~     pro-inflammatory cytokines, and study the genetic predisposition to chronic periodontitis~     (CP) in combination with atherosclerotic cardiovascular (ACD) and aneurysmal diseases. The~     investigators will also try to identify oral bacteria in atherosclerotic plaques and~     aneurysmal walls and thrombus. Histological analyses of atherosclerotic plaques and~     aneurysmal wall will be performed.~   "
168608|NCT01358617|"~     This research study is studying biomarkers in tumor tissue samples from young patients with~     neuroblastoma. Studying samples of tissue from patients with cancer in the laboratory may~     help doctors identify biomarkers and learn more about biomarkers related to cancer~   "
168609|NCT01358604|"~     RATIONALE: Studying samples of tissue and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study studies biomarkers in samples from young patients with~     neuroblastoma.~   "
168610|NCT01358591|"~     The purpose of this study is to assess the effect of a high calcium breakfast on substrate~     metabolism during exercise and appetite throughout the day.~   "
168611|NCT01358578|"~     This study will assess the safety and efficacy of secukinumab compared to placebo and~     etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.~   "
168612|NCT01358565|"~     This is a Phase I, open-label, single-dose study designed to assess the effects of hepatic~     dysfunction on the PK of orally administered Fx-1006A 20 mg soft gelatin capsules.~      An adaptive 2-stage study design will be implemented. Initially (Stage 1), a group of 9~     subjects with moderate hepatic dysfunction (Child-Pugh score of 7-9, inclusive) followed by a~     group of 9 healthy volunteer subjects with normal hepatic function who are comparable in age,~     gender, and weight to the hepatically impaired subjects will be enrolled to receive a single~     oral 20 mg dose of Fx-1006A each.~      Data obtained from the first 2 groups will be analyzed and reviewed by the Sponsor to~     determine whether Fx-1006A PK is altered by hepatic dysfunction. If it is determined that~     hepatic dysfunction affects Fx-1006A PK, then Stage 2 will be commenced. During Stage 2, a~     group of 9 subjects with mild impairment (Child-Pugh score of 5-6, inclusive) will be~     enrolled to receive a single oral 20 mg dose of Fx-1006A each. Additional subjects with~     normal hepatic function may be enrolled to ensure appropriate demographic matching to the~     mild hepatically impaired subjects, with respect to age, gender, and weight.~      During Screening, subjects will provide written informed consent to participate in the study~     and be reviewed against the study entrance criteria (including assessment of hepatic~     function) to determine eligibility. All subjects will provide blood and urine samples for~     clinical laboratory testing, drug testing, and pregnancy testing to determine eligibility.~      Subjects who meet the entrance criteria during Screening will check in to the clinical site 1~     day prior to dosing (Day 0) in the evening, and will be reviewed against the entrance~     criteria to confirm eligibility. Subjects will remain inpatient overnight for pre-dose~     assessments. Subjects will be fasted for a minimum of 8 hours prior to dosing the following~     day (water is allowed).~      The single Fx-1006A dose will be administered on Day 1 under supervision of the Investigator~     or appropriate clinical site staff. Subjects will remain fasted for 4 hours after dosing~     (water is allowed) and will remain inpatient overnight for safety monitoring and PK sample~     collection.~      Subjects will be discharged on Day 2, after they have completed the study procedures and the~     Investigator has determined that the subject is clinically stable. Subjects will return to~     the clinical site for out-patient visits on Days 3, 4, 6, 9, 12, and 16 for safety~     evaluations and PK sample collection. Day 16 will be the end of study visit.~   "
168613|NCT01358552|"~     This is an observational study in which patients who have been prescribed Néevo®/NéevoDHA®~     are invited to participate in surveys about their pregnancy and experiences with~     Néevo®/NéevoDHA®. The purpose of this study is to increase the understanding of the role of~     L-methylfolate among patients who are candidates for Néevo®/NéevoDHA®, provide patients with~     personalized education and support during their pregnancies, and contribute to the overall~     understanding of the needs and concerns of women facing intermediate- to high-risk~     pregnancies.~   "
168614|NCT01358539|"~     Rationale: Although radiotherapy is an effective palliative treatment for patients with~     painful bone metastases with over 70% responders, pain intensity is not always sufficiently~     controlled. Recent analyses from the randomized Dutch Bone Metastasis Study on 1157 patients~     show that during weekly follow up, 35% of the patients remain above a pain intensity level of~     4 on a numeric rating scale (range 0-10) despite pain medication. According to the WHO~     criteria, a pain intensity of 5 or higher prompts treatment. As advised in the CBO guideline~     'Pijn bij Kanker' educating patients can improve patient empowerment and thereby pain~     control. However, the effect of a nurse-led education of patients undergoing palliative~     radiotherapy for painful bone metastases has not been investigated yet.~      Objective: This project investigates whether nurse-led pain education in addition to standard~     care results in better control of pain in patients referred for palliative radiotherapy.~      Study design: A national multicenter phase 3 study (n=450).~      Study population: Patients with painful bone metastases referred for short schedule~     radiotherapy.~      Intervention: Patients will be randomized between standard care or standard care with the~     Pain Education Program, a nurse-led pain education. The pain Education Program will be~     provided on the same day the radiotherapeutic treatment will start. The nurse will first~     assess the knowledge of a patient based on a structured interview. Thereafter, lacunas will~     be taught using the 'Pijninstructie Programma' (Pain Education Program). In addition, nurses~     will telephone patients at regular intervals during follow-up to monitor their needs.~      Main study parameters/endpoints: The primary outcome of this randomized multicenter study is~     a decrement of the number of patients whose worst pain intensity remains above 4 at any time~     during the 12 weeks of follow up with regard to the control group. The secondary outcome is~     improvement of quality of life.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: All patients will fill out the Brief Pain Inventory, the EORTC QLQ-C15-PAL and~     the EORTC QLQ-BM22 at baseline and, thereafter, weekly for 12 weeks after randomization.~   "
168615|NCT01358526|"~     The primary objective of this study is to assess the efficacy and safety of OXN compared to~     placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back~     pain who require around-the-clock opioid therapy.~   "
168698|NCT01357447|"~     Patients with Sjogren's disease have destruction of the mucus secreting cells in the airway.~     This manifestation of the disease leads to the common complaint of persistent dry cough that~     is seen in many of these patients. This study is aimed at determining whether the regular use~     of Pulmozyme will result in decreased cough and improved quality of life.~   "
168616|NCT01358513|"~     The aortic valve is the main outlet valve from the heart. This valve can become diseased and~     narrowed when it needs to be replaced with an artificial valve. Currently, this is the~     commonest reason for someone to undergo a heart valve operation in the UK. Unfortunately,~     there are no medical treatments that can prevent or delay the progression of this disease~     process. Here, the investigators propose to use new state-of-the-art imaging techniques to~     better understand the disease process so that the investigators can effectively design and~     assess potential new treatments. The ultimate aim is to stop this disease before patients~     need to have surgery. In addition the investigators believe this technique will allow us to~     predict the rate of progression of the disease~   "
168617|NCT01358500|"~     This study seeks to determine the suitable doses of fentanyl with acceptable adverse effect~     and safety profile in opioid-dependent patients. The investigators anticipate that a well~     tolerated dose of fentanyl which produces demonstrable analgesia will be found and will be~     related to the patient's maintenance opioid dose.~   "
168618|NCT01358487|"~     The purpose of the study is:~        1. to study whether individuals WHO ARE NOT CURRENTLY SERIOUSLY DEPRESSED will participate~          in an online study to prevent clinical depression and~        2. to estimate the percentage of participants who will complete online assessments at 1, 3,~          and 6 months when receiving either a) email reminders + monetary online incentives or b)~          email reminders + monetary incentives + phone calls.~      NOTE: RECRUITMENT IS COMPLETED.~   "
168619|NCT01358474|"~     The purpose of this study is to determine if participants have changes in dopamine cells in~     their brain using DaTSCAN™ brain imaging. Dopamine cell loss occurs in Parkinson's disease~     (PD) and other degenerative Parkinsonian disorders, but does not occur in most other movement~     disorders such as essential tremor or dystonia. DaTSCAN, which is also known as~     123I-Ioflupane, is a new compound that has been developed by General Electric, Inc. and has~     been approved by the US Food and Drug Administration (FDA) to help doctors detect changes in~     dopamine. This test is performed by injecting DaTSCAN into a vein in the arm, and after a few~     hours, a large amount of DaTSCAN temporarily accumulates in an area of the brain where there~     are a lot of dopamine brain cells. Because DaTSCAN contains a small amount of radioactive~     iodine, it allows doctors to use a special machine called single photon emission computed~     tomography (SPECT) scanning to detect the location and amount of radioactivity in the brain~     and help determine if there are changes in brain dopamine. It is hoped that this study will~     help doctors detect the presence of dopamine changes even before symptoms are present. This~     study will evaluate DaTSCAN in people with PD, those who are at risk for developing PD (e.g.,~     those with idiopathic rapid eye movement sleep disorder (iRBD) and those who are heterozygous~     or homozygous for Gaucher's disease (GBA) mutations) and those who are healthy volunteers.~   "
168620|NCT01358461|"~     Context~      The investigators recently demonstrated a highly significant increase in muscarinic receptor~     density in the myocardium of infants deceased from sudden infant death syndrome (SIDS)~     compared to those of infants deceased from identified causes 1. Muscarinic receptor~     overexpression was found in all SIDS samples studied to date. It was associated with an~     average increase in acetylcholinesterase activity, appearing as a compensatory mechanism to~     oppose the cardiac muscarinic receptor overexpression. Similar vago-cardiac abnormalities~     were detected in a rabbit model of vagal hyperreactivity that the investigators first~     described some years ago2. In these hyperreactive animals, expression of muscarinic receptors~     was also enhanced in blood white cells. Noticeably, the pattern of changes in these cells~     paralleled the pattern of changes in the heart. Thus, muscarinic abnormalities in cardiac~     tissues could be inferred with high confidence from those measured in lymphocytes.This was~     the first report of a vago-cardiac abnormality in sudden infant death syndrome. The~     investigators findings also provided original and important perspectives for the~     identification and therapeutic management of infants at risk of sudden death. As such, the~     publication of the investigators work raised a major interest from the population and from~     the scientific and medical communities, in particular cardio-pediatricians. ObjectivesThe~     objective of the present clinical project is to validate, in human lymphocytes, muscarinic~     receptor expression level (assessed by quantitative RT-PCR) as a circulating biomarker of~     autonomic nervous system dysfunction and more specifically, of vagal hyperactivity and of~     risk of sudden death. The project will include 2 major items, conducted in parallel:1.~     evaluation of the muscarinic receptor expression in lymphocytes from adults with vagal~     syncopes (n=60 patients from an existing file versus 60 controls) (Cardiology unit + Clinical~     Investigation Centre (CIC) + Laboratory of Neurobiology and Cardiovascular Pharmacology); 2.~     evaluation of the muscarinic receptor expression in lymphocytes from children with vagal~     syncopes (n=60 versus 60 controls) (Pediatry unit + Clinical Investigation Centre +~     Laboratory of Neurobiology and Cardiovascular Pharmacology).PerspectivesThis project~     represents the first step of validation of a circulating marker of vagal hyperactivity and of~     risk of SIDS in human. Once this step is completed, the investigators will start with the~     prospective study  muscarinic receptor expression in lymphocytes and SIDS  (cord blood~     collected at birth and follow up of the new-borns) (Maternity ward + CIC + Laboratory of~     Neurobiology and Cardiovascular Pharmacology). Then therapeutic preventive management becomes~     a realistic objective. A therapeutic clinical study will then be started with atropinic~     drugs, in order to test their potential protective action against sudden death. The final~     objective of the investigators research is the prevention of SIDS through i) identification -~     as soon as birth - of new-borns at high risk and ii) appropriate prophylactic therapy. The~     investigators work also opens exciting perspectives in the field of the still poorly~     understood vagal disorders in children and adults such as vagal pauses.1 Livolsi et coll,~     Plos One 5, e9464, 2010 ; 2 Livolsi et coll, Circulation 106, 2301-2304, 2002~   "
168621|NCT01358448|"~     In 2007 the Expert Committee published recommendations on the prevention and treatment of~     childhood obesity. These recommendations outlined four interventions intended for advancement~     based on the child's age, body mass index (BMI), and response to treatment. The initial~     stage, Prevention Plus, is to be implemented in the primary care setting and focuses on~     primary care providers monitoring growth monthly and delivering intervention messages that~     target dietary and leisure-time behaviors that most contribute to energy imbalance in~     children. Little research has evaluated the efficacy of these recommendations. Thus the~     primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus~     stage for treating childhood overweight and obesity in a primary care setting. As the cost of~     interventions is a large barrier to the translation of evidence-based research into primary~     care settings, a second goal of the project is to evaluate program cost-effectiveness.~   "
168622|NCT01358435|"~     The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30~     with regard to its total and to its maximum serum insulin concentrations.~   "
168623|NCT01358422|"~     Research questions:~        1. What is the absolute risk reduction for in-hospital major adverse cardiac events (MACE)~          associated with the use of dual anti-platelet therapy as compared with aspirin alone in~          this population?~        2. What is the absolute risk increase for clinically significant bleeding during the same~          period associated with the use of dual anti-platelet therapy as compared with aspirin~          alone in this population?~      In brief the design of the study is as follows:~        -  We will study patients undergoing non-cardiac surgery within four years of coronary~          stenting.~        -  We will record the anti-platelet agents taken by patients before, during and after~          surgery.~        -  We will record cardiac and bleeding events that occur whilst the patient is in hospital.~        -  We will use the statistical technique of propensity scoring to match patients who have~          similar risk factors and who received different anti-platelet regimens.~        -  We will compare the incidence of cardiac events and bleeding in the matched groups.~   "
168624|NCT01358409|"~     Within large number of patients with obesity, it is crucial to determine who is at the~     greatest risk for development of chronic heart disease. The investigators previous studies~     suggest that an excessive accumulation of fat in heart cells precedes the development of~     obesity-related pathologies and may serve as a biomarker of heart disease in high-risk~     population. Until now, the evaluation of fat in the human heart was possible postmortem or by~     biopsy. The investigators novel magnetic resonance spectroscopy technique enables the~     quantification of intracellular lipid content non-invasively and repeatedly in humans in~     vivo. It could be used to better screen and treat obese patients at risk for the development~     of metabolic disease. The investigators hypothesize that in obese humans with elevated~     myocardial triglycerides, treatment with Nebivolol will reduce myocardial fat and will~     improve heart function.~   "
168625|NCT01358396|"~     Does diabetic patients' glycemic control affect their response to laser and/or intravitreal~     injection therapy in terms of visual and anatomical outcomes.~   "
168626|NCT01358383|"~     This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult~     volunteers.~   "
168627|NCT01358370|"~     This is a Natural History study to characterize key aspects of the clinical course of~     lysosomal acid lipase (LAL) deficiency/Wolman phenotype in patients.~   "
168628|NCT01358357|"~     This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study~     designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or~     divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without~     rapid cycling and /or psychotic features.~   "
168630|NCT01358331|"~     This study of the safety, tolerability, and efficacy of MK-8353 (formerly SCH 900353) given~     as single agent oral therapy for participants with advanced solid tumors will be done into~     two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum~     tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2~     dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants~     with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to~     see if MK-8353 is effective as single agent therapy.~   "
168631|NCT01358318|"~     The purpose of this study is to determine whether ingestion of a bar containing either added~     soy protein or soy fiber or both, increases subjective and objective measures of satiety~     compared to a control bar.~   "
168632|NCT01358305|"~     Soy protein is a high quality, plant-based protein that is comparable to milk, meat and eggs.~     Soy protein has a digestion rate (intermediate) compared to whey (fast) and casein (slow).~     This intermediate rate may allow soy protein to have an extended window of muscle protein~     synthesis that has not been monitored in previous studies. While most of the sports nutrition~     recovery products are dairy-based protein blends (high in branched-chain amino acids), soy~     protein offers additional benefits that can make an important contribution to these types of~     sports nutrition products. Soy protein contains approximately 300% more arginine and 30% more~     glutamine compared to whey protein and these two amino acids may bring additional benefits~     (immunity and hydration, respectively) to athletes. A blend of high-quality proteins (soy~     and dairy) may be the optimal sports nutrition product for athletes to consume following~     training.~   "
168633|NCT01358292|"~     Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for~     extra-articular tibial fractures treated with Smith& Nephew's Trigen META intramedullary~     nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee~     flexion) and Group B=with the semi-extended surgical technique. (2*100 patients)~      Research Objectives:~      The primary research objectives are to evaluate:~      i) anterior knee pain and ii) the nail position and overall fracture alignment~      Outcome Measures:~        1. Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.~        2. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by~          means of Patient questionnaires~        3. Knee-related adverse events~        4. Overall fracture alignment~   "
168634|NCT01358279|"~     This study is conducted to investigate the therapeutic efficacy and safety of transcranial~     direct current stimulation (tDCS) over the primary motor cortex of patients with acute~     migraine attack.~   "
168635|NCT01358266|"~     The purpose of this study is to evaluate the safety and efficacy of intravitreal injections~     of DE-109 ophthalmic solution.~   "
168636|NCT01358253|"~     The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined~     with chemotherapy in CD20+ adult acute lymphoblastic leukemia.~   "
168637|NCT01358240|"~     This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle~     in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week~     study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will~     also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for~     blinding purposes only.~   "
168638|NCT01358227|"~     The purpose of this study is to determine the side effects and best weekly dose of PR104 in~     patients with advanced solid tumors.~   "
168639|NCT01358214|"~     Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a~     TiLOOP® TAPE surgical mesh for stabilization of the urethra.~   "
168640|NCT01358201|"~     The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are~     fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and,~     consequently, the results of treatment are substantially lower. Additionally, elderly~     patients tolerate the drugs considered relatively low-key in the management of the LAL and~     suffer more toxicity. Although the LAL is much more common in patients over 60 years of age~     than in younger adults, older adults with ALL are clearly underrepresented in prospective~     controlled studies. A good portion of elderly patients are not able to tolerate the intensity~     of the standard treatment applied to children or young adults and a significant portion of~     them receive only palliative or supportive treatment. The data in the literature relating~     specifically to the elderly population are scarce and most of them have obtained a~     stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date,~     the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients~     because this protocol less aggressive than those used in high-risk ALL. However, the~     development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a~     relatively common type of LAL in the older patient, requires a differentiated treat these~     patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol~     has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a~     significant benefit in survival related to the reduction of treatment (removal of the~     L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a~     reduction in toxicity~   "
168641|NCT01358188|"~     Gaucher disease (GD), the inherited deficiency of the lysosomal enzyme glucocerebrosidase is~     characterized with accumulation of abnormal lipid in cells of the immune system, called~     macrophages. Lipid engorged macrophages, then become activated, and are also called Gaucher~     cells. The mechanisms leading to macrophage activation is not fully known, however several~     findings in individuals with GD, such as non-specific inflammation,clinically resembling a~     rheumatic disease with an increased sedimentation rate, joint pain, and extreme fatigue, in~     addition poor wound healing, and a predisposition to diabetes may suggest an inappropriately~     functioning immune system in GD. The pathways leading to macrophage activation could be~     related to the accumulation of lipid metabolites or through the effects of other immune~     cells. In this study, immunologic profiling and functional assays will be performed in~     peripheral blood samples from patients with GD. The identification of the immunologic basis~     of GD will lead to the the development of new disease markers and different treatment~     options.~   "
168642|NCT01358175|"~     This study will assess the efficacy and safety of secukinumab in patients with active~     ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs,~     DMARDs and / or TNFα inhibitor therapy.~   "
168643|NCT01358162|"~     Healthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the~     safety and tolerability and pharmacokinetics.~   "
168645|NCT01358136|"~     The hypothesis of the study is that among patients that do not develop overt hypothyroidism~     after hemithyroidectomy, weight gain is a clinical manifestation of a postoperatively lowered~     set point of thyroid function - even if the thyroid function is lowered within the laboratory~     reference range. The investigators refer to this hypothesized condition as individual~     subclinical hypothyroidism.~      Thyroid hormones are major regulators of mitochondrial function and subclinical~     hypothyroidism affects mitochondrial activity. The aim of the study is to examine if a~     lowered set point of thyroid function after hemithyroidectomy can be measured in the~     mitochondrial function, the body weight and the basal oxygen consumption.~   "
168646|NCT01358123|"~     In patients with liver cirrhosis elevated levels of von Willebrand factor antigen (vWF-Ag)~     are found frequently but the clinical significance is unclear. vWF-Ag plays an important role~     in primary haemostasis and development of thrombotic vascular obliteration is discussed as a~     possible mechanism leading to portal hypertension. Invasive measurement of hepatic venous~     pressure gradient (HVPG) is the current gold standard for the diagnosis of portal~     hypertension. The investigators hypothesize that vWF-Ag levels in plasma may correlate with~     portal pressure and predict clinically significant portal hypertension (CSPH, HVPG >=10mmHg)~     and its complications.~   "
168647|NCT01358110|"~     The purpose of this study is to: 1) identify the palliative care needs of Emergency~     Department patients with advanced cancer, and determine if these needs can be rapidly~     assessed in the ED; 2) determine whether early palliative care consultation improves~     survival, quality of life and other burdensome symptoms and decreases utilization as compared~     to usual care.~   "
168648|NCT01358097|"~     The purpose of this study is to investigate the role of the immune system in the response of~     squamous cell cancers of the head and neck to treatment that includes radiation therapy.~     Current research demonstrates that several natural immune cells and molecules affect the way~     the body's immune system interacts with a cancerous growth. Some cancers may be related to~     infection with a virus, such as the Human Papilloma Virus (HPV). Studying the activity of the~     immune system in head and neck cancers, especially cancers related to HPV infections, can~     provide valuable information to better understand the body's interaction with cancer cells.~   "
168649|NCT01358084|"~     The main objective of the trial is to document the efficacy of NGR-hTNF administered as~     maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma~   "
168650|NCT01358071|"~     The primary objective of this randomized phase II trial is to compare progression-free~     survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients~     randomized to an anthracycline alone~   "
168651|NCT01358058|"~     In this research study the investigators are looking at a type of radiation called proton~     radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area~     of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects~     that patients would normally experience with conventional radiation therapy.~      In this research study the investigators are looking to determine if proton radiation with a~     reduced field size will be as effective in controlling tumor growth as photon therapy, while~     reducing the treatment-related side effects observed in patients with brain tumors.~   "
168652|NCT01358045|"~     Basal cell carcinoma (BCC) is the most frequent malignant tumor in Caucasians and the~     incidence is still increasing with 3-8% each year. Since BCCs generally occur on sun-exposed~     areas of the skin, the rice in incidence is mainly explained by the increasing exposure to~     (intermittent) ultraviolet radiation. Surgical excision is still the standard treatment for~     (micro)nodular BCCs. The costs as well as the increased workload are stressing the health~     care system even further and posing BCC an important health care problem. Since half of the~     BCCs arise primarily on the face & (bald) head and treatment by surgical excision may result~     in disfiguring scars, patients often experience a dramatic decrease of their quality of life.~     Hence, there is an urgent medical and societal need for a simple and cheap (targeted)~     treatment, preferably to be performed by the patients themselves. This treatment must be safe~     and effective. Such treatment is not available yet. BCC tumorigenesis is complex and must be~     multifactorial. Genetic alterations of multiple components of the Sonic Hedgehog (SHH)~     pathway are involved in sporadic BCC pathogenesis; inactivating mutations in Patched-1~     (PTCH1) and activating mutations of Smoothened (SMO) and Suppressor of Fused (SU(FU)). With~     this knowledge, inhibition of the SHH pathway by SMO antagonists was successfully~     administered, however treatment resulted only in partial clinical response ofBCC. Recently,~     involvement of the Wingless (Wnt) pathway has been proven to be essential in BCC tumorigenic~     response. Moreover, a recent study of our own department provides the first evidence that~     epigenetic alterations, particularly promoter hypermethylation, influence both the SHH and~     Wnt pathway (own data, not published), which can serve as therapeutic targets. Both~     non-steroidal anti-inflammatory drugs (NSAlDS) and vitamin D derivatives are able to directly~     or indirectly target the Wnt pathway. Furthermore, vitamin D3 is able to inhibit Smoothened~     (SMO) in vitro, resulting in inhibition of the SHH pathway. Although in vivo studies are~     lacking, the investigators assume that topical application of these drugs may inhibit BCC~     growth and/or may cure BCC and thus might provide very promising future perspectives.~     Calcitriol and NSAlDs ointments are both already available for other indications and save in~     use. Eventually, our approach may result in a systematic approach to BCC, targeting~     (epi)genetic changes to treat and/or prevent further tumour growth.~   "
168653|NCT01358032|"~     The main objectives of this study are:~        1. an effect evaluation of an in-home multicomponent cognitive behavioural program on~          concerns about falling and related avoidance of activity (primary outcomes), as well as~          disability, fall incidents (secondary outcomes) and several additional outcomes in frail~          community-dwelling older people,~        2. a process evaluation of the feasibility of the program, with the following main~          outcomes: population reached, performance according to protocol, exposure and~          engagement, opinion on the program of participants and facilitators, perceived benefit~          or achievement, and experienced barriers and potential solutions, and~        3. an economical evaluation on the impact of the program on healthcare utilization and~          related costs.~   "
168654|NCT01358019|"~     The primary objective of this study is to examine a recommended dose for subsequent phase~     trial(s), by the observation of the safety and toxicity profiles of LY2523355 in patients~     with advanced and/or metastatic cancer. The secondary objectives are to study the~     pharmacokinetics and antitumor effect.~   "
168655|NCT01358006|"~     The purpose of this study is to characterize the 5-HT2A binding over the maximum feasible~     dose range of JNJ-40411813, to estimate the plasma concentration associated with 50% 5-HT2A~     binding, and to investigate the safety and tolerability of JNJ-40411813 in healthy male~     volunteers.~   "
168656|NCT01357993|"~     The main purpose of this study is to evaluate long-term safety and tolerability of JNS001 at~     18 to 72 mg per day in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
168714|NCT01357239|"~     This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective~     in treating the behavioral symptoms of Fragile X Syndrome.~   "
168658|NCT01357967|"~     Recently, there are increasing data about intensity dependent amplitude change (IDAP: N100~     amplitude slope) of auditory evoked Event Related Potential (ERP) components for its role on~     surrogate marker of central serotonergic activity. A high N100 amplitude slope reflects low~     serotonergic neurotransmission and vice versa. There are a couple of studies reporting~     associations of N1 amplitude slope with response to Citalopram (positive correlation) and~     Reboxetine (negative correlation) treatment in major depressive disorder patients (2,3). The~     investigator also published a case series about SSRI super-sensitivity and SSRI induced mania~     in patients with aberrantly high N100 slope (4). And serotonin transporter gene polymorphism~     was studied for its role about pathophysiology of bipolar disorder (5, 6, 7). Serotonin~     promoter gene was known to have significant relationship with N100 amplitude slope (8).~     Furthermore previous study showed that N100 amplitude slope was well correlated with~     hypomanic and hyperthymic personality (9).~      Conclusively from above results, the investigator hypothesized that if depressive patients~     show aberrant high or low N100 amplitude slope (N100 response outliers), they will not~     response well to SSRI medication. They will response better to quetiapine XR adjunctive~     therapy. In this study, the investigator will confirm it by comparing treatment effect~     between SSRI monotherapy and quetiapine XR adjunctive in aberrant N100 responder.~      Hypothesis First visit depressive patients might have monopolar or bipolar depression. If~     depressive patients show aberrantly high or low N100 amplitude slope, they will not response~     to SSRI medication.~      Patients who have aberrantly high or low N100 amplitude slope will response better to~     quetiapine XR adjunctive therapy.~   "
168659|NCT01357954|"~     The project aims to test the effectiveness and explore the possibility of performing a novel~     therapeutic approach, targeting to increase strength and coordination around the trunk,~     giving a more active and functional seating and head control in those children with cerebral~     palsy (CP) who are wheelchair users. The project will also try to determine the muscle~     physiological effect of treatment using indirect measures of strength in the spinal~     musculature.~   "
168660|NCT01357941|"~     Pregnant women with a prior history of venous thromboembolism (VTE) are at increased risk of~     recurrent VTE. Current guidelines assessing the role of prophylaxis in pregnant women with~     prior VTE are based primarily on expert opinion and the optimal clinical management strategy~     remains unclear.~      This multicentre, prospective cohort study aims to test the following hypotheses:~        1. Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe,~          convenient and associated with an acceptably low risk of recurrent VTE in women with a~          single prior episode of VTE that was either unprovoked or associated with a minor~          transient risk factor. (Moderate risk cohort)~        2. Withholding antepartum prophylaxis is safe (recurrence risk <1%) in pregnant women with~          a single prior episode of VTE provoked by a major transient risk factor. (Low risk~          cohort)~      All study patients will receive 6 weeks of postpartum prophylaxis.~   "
168661|NCT01357928|"~     As part of a system wide reagent verification plan Haemoscope Corporation will be running a~     study to verify the reference intervals of many of the reagents. Reference intervals will be~     constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls~     for a reference interval to be constructed from at least 120 donors. Some reagents currently~     have ranges in place based on fewer donors than that stated in the guideline. This procedure~     will provide additional testing results to meet the requirements outlined in the CLSI~     guideline. Reagents that currently have no reference intervals will be tested and will~     include a minimum of 146 donors.~   "
168662|NCT01357915|"~     The purpose of this study is to evaluate the persistence of the vaccine induced immune~     responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3 doses~     of GSK Biologicals' candidate CMV vaccine according to a 0-1-6 month schedule during the~     primary study 108890 (NCT00435396) (vaccine group). The immune response to CMV infection in~     naturally infected subjects who participated in the screening visit of the primary study~     108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value~     (seropositive reference group). In addition, this study will continue to assess the~     occurrence of CMV infections as well as the continued development and validation of read-outs~     in the CMV project.~      The primary vaccination phase and Year 2 follow-up were posted as a separate protocol posting~     (NCT00435396).~   "
168663|NCT01357902|"~     It is an open-label, randomised, single dose, two-sequence cross-over study. Twenty-four~     eligible, healthy, Chinese male subjects will be enrolled after providing written informed~     consent. Subjects will be randomised into two treatment groups 1 day prior to the first~     dosing day and will be assigned to regimen sequences (AB or BA) in a balanced fashion in~     accordance with the randomisation schedule. Regimen A is five lamotrigine 5 mg~     chewable/dispersible tablets and Regimen B is one lamotrigine 25 mg standard/compressed~     tablet.~      Subjects will receive their allocated regimen on the morning of Day 1 and will undergo study~     assessments for 7 days (until Day 8). Subjects will receive their alternate randomised~     treatment after a washout period of 14-21 days from Day 1. Subjects will undergo a further~     assessment period of 7 days and will attend a follow-up visit during 8-12 days after the~     second treatment. The total observation period in this study will be 23~34 days.~      Subjects will arrive at the research unit on the evening before each lamotrigine dosing~     occasion and will remain in the unit until the 24-h post-dose evaluations have been completed~     (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h). After this, subjects will return~     home but must return to the unit for further assessments to be made at 36, 48, 72, 96, 120,~     144 and 168 h after dosing Study Endpoints/Assessments A total of 19 serial blood samples (5~     mL each) will be collected for the measurement of plasma lamotrigine concentrations at each~     study assessment. Safety and tolerability assessments (monitoring of adverse events and~     serious adverse events, routine laboratory determinations, vital sign measurements and~     12-lead electrocardiogram) will be conducted throughout the study.~   "
168664|NCT01357889|"~     The first part of the study includes a single dose treatment period to evaluate the~     pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug~     substance compared with process 3 drug substance. The second part of the treatment period~     will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and~     tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug~     substance compared with process 3 drug substance. Subjects with type 2 diabetes whose~     glycemia is inadequately controlled on their current regimen of diet and exercise or stable~     dose of metformin will be recruited into the study.~   "
168665|NCT01357876|"~     Metformin is a biguanide that is marketed as an oral anti-diabetic drug. Metformin treatment~     in concert with diet and exercise is the consensus first-line treatment for type 2 diabetes~     mellitus (T2DM), and therefore it will likely be an adjunct therapy for all assets in~     development by GSK for the treatment of T2DM. Metformin has potent effects in lowering~     circulating glucose concentrations, and it is believed to have additional benefits in~     improving macrovascular outcomes, fatty liver disease and polycystic ovarian syndrome. Its~     use in a significant proportion of T2DM subjects is limited by contraindications of heart~     failure and renal insufficiency or gastrointestinal side effects. The mechanisms underlying~     its glucose-lowering effect and adverse event profile of metformin are not well understood.~     Whilst activation of AMP kinase may be important for therapeutic effect, changes in incretin~     secretion and bile acid excretion have been described, but not consistently linked to its~     therapeutic effect or AE profile. The aim of this study is to recruit T2DM patients on~     prescribed metformin monotherapy to further investigate how the glucose effects are related~     to the alterations in bile acid absorption, incretin and lipid profiles by studying these~     parameters on and off the drug. This will be done in combination with frequent capillary~     blood glucose monitoring to ensure patient safety. This study will facilitate the development~     of a pharmacodynamic model that can be used by clinical teams developing non-absorbable NCEs~     such as iBAT inhibitors.~   "
168666|NCT01357863|"~     The study will be conducted as a multicenter prospective observational cohort study, trying~     to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast~     cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing~     outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after~     1st Trastuzumab progression (second line treatment), and Group 2: patients receiving~     Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression~     (third line or greater).~   "
168667|NCT01357850|"~     This exploratory proof of concept study will be conducted in patients with stable New York~     Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is~     to test the hypothesis that GSK716155 administration will increase glucose uptake and~     utilization in the myocardium, resulting in increased myocardial efficiency and increased~     exercise capacity. A positive result, defined as either statistically significant effects on~     one or more of the efficacy endpoints or as an overall signal suggesting a clinically~     relevant effect on myocardial physiology, would provide evidence for potential progression~     into further development in a chronic heart failure population.~   "
168668|NCT01357837|"~     The purpose of the trial is to determine whether GRT6005 is effective in patients with pain~     due to osteoarthritis of the knee.~   "
168669|NCT01357824|"~     The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on~     the throat, just below the Adams apple, to occlude the esophagus, in order to prevent~     aspiration of gastric contents, on intubation with a flexible fiberscope. The result of this~     study will be participate in the discussion of the importance of Sellick´s Maneuver.~   "
168670|NCT01357811|"~     The primary objective of this study is to determine the effect of repeat oral doses of~     eliglustat 150 mg twice daily (BID) (or 100 mg BID for CYP2D6 poor metabolizers) on the~     pharmacokinetics (PK) of orally administered digoxin 0.25 mg in healthy adult subjects. This~     will be a single-site, open-label study in 2 staggered cohorts of healthy adult subjects. The~     study will comprise a screening period (between Day -45 and Day -2), treatment period 1 (Day~     -1 to Day 4), treatment period 2 (Day 11 to Day 18), and a safety follow-up visit (Day 24 ±~     1). There will be a 10-day washout between dosing of study drug in Period 1 and Period 2. The~     duration of each subject's participation in the study, inclusive of the screening and~     follow-up visits, will be approximately 10 weeks.~   "
168671|NCT01357798|"~     The objective of this study is evaluated if the Botulinum Toxin Type A is superior to 0,9%~     saline in treatment of cranial Allodynia in patients with headache.~      Hypothesis~      H(0): Botulinum Toxin Type A is not superior to 0,9% saline in treatment of cranial Allodynia~     in patients with headache~      H (1): Botulinum Toxin Type A is superior to 0,9% saline in treatment of cranial Allodynia in~     patients with headache~   "
168672|NCT01357785|"~     The purpose of this clinical trial is to both clarify the efficiency of autologous~     periodontal ligament (PDL) stem cells to regenerate periodontal tissue in periodontitis~     patients with deep intraosseous defects (>5 mm) and to confirm the safety of using autologous~     stem cells in clinical periodontal regenerative medicine. This is a single-centre,~     randomized, placebo-controlled study. This study has been approved by the ethical committees~     of School of Stomatology, Fourth Military Medical University. The study will be conducted~     according to the Declaration of Helsinki.~   "
168673|NCT01357772|"~     The long-lasting phase of precursors of invasive cancer, i.e. dysplasia or intraepithelial~     neoplasia (IEN), is particularly relevant among risk determinants. At present, about 15-20%~     of all breast cancers are diagnosed in a non-invasive phase. Despite their good prognosis,~     women with breast IEN (lobular and ductal intraepithelial neoplasia, LIN and DIN) have a~     10-15/1000 annual risk of invasive disease (8-10 times the same age general population), and~     thus represent an important target for chemoprevention. In the National Surgical Adjuvant~     Breast and Bowel Project (NSABP-P1 trial), tamoxifen use at 20 mg/day was associated with a~     86% reduction of invasive breast cancer in women with previous atypical ductal hyperplasia~     (ADH) (RR=0.14, 95% IC, 0.03-0.47) and with a 56% risk reduction in women with previous~     Lobular Carcinoma in situ (LCIS) (RR=0.44, 95% IC, 0.16-1.06). However, tamoxifen use in this~     setting is hampered by serious adverse events attributable to its partial estrogenic~     activity, such as increased risk of endometrial cancer and of venous thromboembolism, which~     have significantly limited its broad use in chemoprevention.~      To improve the risk-benefit ratio, the use of lower doses of the drug has been proposed.~     Recent trials from our group have shown that the dose can be reduced up to 1 mg/day with no~     loss of tamoxifen antiproliferative activity on breast cancer. By contrast, a dose of 5~     mg/day does not increase endometrial proliferation and is associated with a decrease of the~     estrogenic activity of tamoxifen on insulin like growth factor (IGF-I), sex hormone-binding~     globulin (SHBG) and antithrombin-III, with a potential decrease of venous thromboembolic~     events. Moreover, tamoxifen exhibits a high tissue distribution, so that a dose of 5 mg/day~     attains at the breast tissue level a concentration 10 times higher than that needed to~     inhibit cell growth in vitro. The promising clinical activity of 5 mg/day of tamoxifen is~     supported by an ongoing 2x2 phase IIb trial of low-dose tamoxifen and fenretinide in~     premenopausal women, where tamoxifen lowers breast cancer events compared with placebo. The~     cytochromeP450 2D6 (CYP2D6) enzyme mediates oxidation of N-desmethyl tamoxifen to endoxifen,~     the most active metabolite of tamoxifen. The single nucleotide polymorphism (SNP) CYP2D6*4~     (1846G>A) allele accounts for 75% of CYP2D6 poor metabolizer phenotype and poor metabolizers~     showed a trend to a higher risk to develop a breast event compared to wildtype.~   "
168674|NCT01357759|"~     This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in~     healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine~     the safety and tolerability of MORAb-022.~   "
168675|NCT01357746|"~     This is a non-invasive study using a standard doppler echocardiographic transducer which~     records signals emanating from the lungs (TPD). These signals are caused by pulsation of~     blood vessels in the lung tissue.~      The innovations in this study are:~        1. The software processing of the reflected ultra-sound waves from the lung rendering a~          reproducible, clear and strong signal in sync with the cardiac cycle,~        2. The observation based on pilot studies that blowing hard against resistance during~          recording (something called a Valsalva maneuver), affects the lung signal weakening it~          and even obliterating it as the pressure rises.~      The investigators hypothesis is that since the signal comes from the blood vessels in the~     lung, the pressure at which the recorded signal disappears during the Valsalva maneuver~     represents the blood pressure in the lungs.~   "
168676|NCT01357733|"~     Newly diagnosed diffuse large B cell lymphoma (DLBCL) patients who enter this study will~     receive baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) computed~     tomography (CT) scan at the time of initial staging. The patients will be diagnosed and~     undergo initial staging according to The Catholic University Lymphoma Group (CULG) Protocol.~      After 1 cycle of rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone~     (R-CHOP) chemotherapy, early interim FDG PET/CT will be obtained after the patient recovers~     from nadir (usually 13 to 16 days after) following the administration of first cycle of~     R-CHOP,immediately before the second cycle of R-CHOP. The result of early interim FDG PET/CT~     study will not impact patient management, except in rare case where newly developed lesion is~     found and biopsy confirmed.~      The same PET/CT system and analysis software will be used for all scans from baseline to~     surveillance for all patients enrolled in this study.~      After 3 cycles of R-CHOP, a mid-therapy interim FDG PET/CT will be obtained. Patients with~     newly developed lesion will receive different chemotherapy regimen, while patients with~     stable disease, partial metabolic response or complete metabolic response will continue to~     receive 3 more cycles of R-CHOP.~      After the completion of 6 cycles of R-CHOP, the patients will receive a FDG PET/CT scan for~     response assessment. Selected patients with persistent disease or very bulky tumor volume on~     initial staging images will receive additional radiation therapy.~      The patients will be followed up every 3 months for 2 years from beginning of therapy.~     Physical examination and lab studies will be done usually every 3 months. Imaging studies~     will be performed every 3 months alternating between enhanced CT and FDG PET/CT and noted~     when different schedule is applied for surveillance.~      The end points are changes in FDG uptake measurements between the baseline and early interim~     FDG PET/CT, and between baseline and mid-therapy interim FDG PET/CT scans; response~     assessment following completion of 6 cycles of R-CHOP with or without radiation therapy~     assessed by International Workshop Criteria (IWC)+PET and PET Response Criteria in Solid~     Tumors (PERCIST) guideline; and the 2 year disease free survival.~   "
168677|NCT01357720|"~     This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by~     Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for~     all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface~     antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and~     anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.~   "
168678|NCT01357707|"~     The project strives to discover novel genetic defects that cause monogenic epilepsy or that~     genetically modify a preexisting epileptic phenotype. Our main aim is to find genetic causes~     for the idiopathic West Syndrome (infantile seizures) that are not caused by known cerebral~     malformation, lissencephaly or metabolic disorders and which have a comparatively benign~     prognosis.~      The investigators hypothesize that mutations in genes coding for ion channels or genes that~     modify the action of ion channels might be causative.~      For that the investigators will perform a sequence analysis of the coding exons of a large~     set of genes in all recruited patients and verify found mutations in their parents.~   "
168679|NCT01357694|"~     The major purpose of this study is to determine whether psychotherapeutic contacts for~     surgical patients with psychological distress are an effective treatment during the~     postoperative period to improve the rate of treatment participation in subsequent~     psychosocial treatment programs.~   "
168680|NCT01357681|"~     Huntington's disease (HD) is an inherited autosomal dominant, progressive neurodegenerative~     disease. Clinically, HD is characterized by a triad of movement disorders, cognitive~     impairments and psychiatric disturbances. These symptoms represent a tremendous burden for~     patients and caregivers. HD is a fatal disorder with neither cure, nor evidence-based~     standard therapy available.~      The green tea polyphenon (2)-epigallocatechin-3-gallate (EGCG) was shown to have beneficial~     effects in cell and animal models of HD. The aim of this study is to evaluate the efficacy~     and tolerability of EGCG in HD.~      The investigators hypothesize that Sunphenon EGCG administered at a maximal daily dose of~     1200 mg compared to placebo during a period of 12 months improves cognition in patients with~     HD. As primary outcome measure, the change of cognitive functions (as measured by the Unified~     Huntington's Disease Rating Scale (UHDRS)-Cognition composite score of Stroop test, Verbal~     fluency & Symbol Digit Modalities Test) after 12 months in comparison to Baseline was~     defined.~      The investigators further expect a positive influence of EGCG on other clinical~     manifestations of HD, measurable effects of EGCG on HD biomarkers and good safety and~     tolerability of EGCG in HD patients.~   "
168681|NCT01357668|"~     The purpose of this study is to examine the long-term safety of Abatacept for the treatment~     of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of~     serious infections, autoimmune disorders, and malignancies.~   "
168682|NCT01357655|"~     The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP)~     CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.~   "
168683|NCT01357642|"~     This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation~     Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in~     comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist~     (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.~   "
168684|NCT01357629|"~     This study examines the long term Safety Follow-up of first patients vaccinated with AD02.~   "
168685|NCT01357616|"~     The purpose of this study was to compare the intraocular pressure (IOP)-lowering efficacy and~     safety of AZARGA™ (Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension), dosed twice daily~     versus AZOPT® (Brinzolamide 1% Ophthalmic Suspension) and Timolol 0.5% Ophthalmic Solution,~     each dosed twice daily, in Chinese patients with open-angle glaucoma or ocular hypertension~     who were insufficiently responsive to monotherapy.~   "
168686|NCT01357603|"~     The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to~     its total and to its maximum serum insulin concentrations.~   "
168728|NCT01357057|"~     The goal of this observational study is to develop and validate a predictive score of 1-year~     outcomes in subarachnoid hemorrhage (SAH) patients receiving aneurism coiling.~      Using our database filled up prospectively, the investigators plan to collect clinical,~     biological and radiological admission characteristics of coiled SAH cases and their 1-year~     Rankin outcome score during 5 years (2003-2007). The investigators plan to confirm our score~     in a validation cohort (from 2008 to 2009).~   "
168687|NCT01357590|"~     ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending~     thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a~     0.035 guidewire and positioned under fluoroscopic control. If necessary, an arterial conduit~     technique may be required to allow access to the arterial system. The soft tapered tip allows~     atraumatic insertion into the vessel, while the catheter and sheath are designed to provide~     excellent flexibility and control through tortuous arterial anatomy.~      Each individual stent graft device is supplied sterile and pre-loaded in a single-use~     delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin~     wall woven polyester and nitinol ring stents, which are attached to the fabric with braided~     polyester sutures. The delivery system central catheter is a stainless steel braided~     co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide~     significant torque control and strength, while also maintaining superior flexibility. The~     outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless~     steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant~     coating. These materials provide very low friction force during device insertion and~     deployment together with enhanced flexibility of the delivery system. The handle components~     are moulded from thermoplastic polyurethane.~      The materials of the endoprosthesis are identical to those of the current Conformité~     Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal~     aortic aneurysm repair. The materials of the delivery system are well established in medical~     applications. The design of ThoraflexTM is based on the same principles as other clinically~     established thoracic endovascular devices. The endoprosthesis is constructed of~     self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the~     endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery~     system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal~     deployment position can be enhanced.~      The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the~     descending thoracic aorta, which is identical to other CE approved thoracic endovascular~     devices.~   "
168688|NCT01357577|"~     With this research, the investigators hope to learn if cognitive behavioral therapy (CBT) for~     posttraumatic stress disorder (PTSD) works in people who have both PTSD and problems with~     drugs or alcohol. In the past, people who had problems with drugs and alcohol were not given~     treatment for their PTSD. It was believed that PTSD treatment would get in the way of their~     drug and alcohol treatment. Now the investigators believe that the PTSD symptoms may make it~     harder to avoid using drugs and alcohol, so the investigators want to see if people can get~     treatment for both problems at the same time.~      One hundred-sixty Veterans from 3 sites who have both PTSD and substance use disorders will~     be in the study. In order to know if the PTSD treatment is helpful, half of the Veterans in~     this study will receive PTSD treatment and half will continue to get their usual mental~     health and/or substance abuse treatment. Who gets which treatment will be decided by a random~     process. The investigators will then compare the 2 groups to see if there are differences in~     their PTSD symptoms.~   "
168689|NCT01357564|"~     This proposed study addresses this call by testing the efficacy of a transformative~     patient-centric intervention designed to reduce the burden of NPS in Veterans with dementia~     who live at home with family caregivers. The innovative intervention, the Tailored Activity~     Program (TAP-VA), involves 8 sessions over 4 months in Veterans' homes. An occupational~     therapist conducts a systematic assessment to identify a Veteran's preserved capabilities and~     deficit areas, and previous roles, habits and interests from which to develop and introduce~     activities tailored to the Veteran's profile. Family caregivers are then trained to~     incorporate tailored activities into daily care routines. The intervention was pilot tested~     in an NIMH funded study with 60 community-living individuals with dementia. Findings from~     this pilot showed statistically significant and clinically meaningful reductions in NPS,~     specifically agitation and less time being on duty by family caregivers. Results of this~     pilot phase support moving forward with a full-scale Phase III efficacy trial. The~     investigators plan to test TAP-VA in a randomized two-group parallel design in which 160~     racially and ethnically diverse Veterans with dementia and their family caregivers (dyads)~     will be randomly assigned to receive TAP-VA or an attention control group. All dyads will be~     evaluated at baseline and 4-months (main trial endpoint), and then reassessed at 8-months to~     evaluate long-term treatment effects (baseline to 8 months), including continued activity~     use, caregiver well-being, and costs.~   "
168690|NCT01357551|"~     Obesity is the second leading cause of preventable deaths in the United States and is~     associated with a wide range of diseases. In people who are obese, weight loss improves blood~     pressure, dyslipidemia, glycemia, and arthritis symptoms; reduces medication use for several~     disease processes; increases physical functioning; and enhances health-related quality of~     life. The current study evaluated a theoretically informed maintenance intervention. If~     effective, this intervention could reduce the need for future clinic visits to treat obesity~     and its many associated illnesses.~   "
168691|NCT01357538|"~     This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of~     Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis.~   "
168692|NCT01357525|"~     The current study seeks to further investigate the impact of Stereotactic Body Radiation~     Therapy following pancreatic resection with a close or positive margin. The investigators~     hope to improve local control, and through the use of a shortened treatment schedule, allow~     patients to begin systemic therapy earlier.~   "
168693|NCT01357512|"~     The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging~     (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer~     based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized~     to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided~     biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI~     evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.~   "
168694|NCT01357499|"~     The purpose of this study is to investigate if remote ischemic preconditioning by combining~     limb ischaemia with electric muscle stimulation of the ischemic muscle provokes better~     results in preconditioning the human heart than limb ischaemia alone does.~   "
168695|NCT01357486|"~     The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in~     France and about 2 / 3 of patients, are not eligible for curative treatment at the time of~     diagnosis. The palliative management of patients with advanced and symptomatic disease is~     complex and requires treatment combining anti-tumor activity and safety in patients with~     impaired liver functions. Sorafenib is the standard of care in a palliative setting, but the~     benefit of sorafenib in patient with altered liver function is uncertain. The aim of this~     trial is to study the interest of sorafenib in patients with HCC and impaired liver function~     compared to pravastatin (a drug with anti-tumoral activity in HCC) or to the combination~     sorafenib/pravastatin or to best supportive care (usually used in these patients).~   "
168696|NCT01357473|"~     The proposal of this study is to evaluate the association between the achievement of ongoing~     pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH-~     antagonist cycles.~   "
168699|NCT01357434|"~     Rating systems are intended to guide consumer choices. This project will determine if a~     previously developed scale that evaluates the healthiness of a restaurant is correlated~     with the actual choices consumers make when they patronize the restaurants. The study will~     also assess whether a restaurant marketed as healthy (Subway) rates higher on this scale~     than another restaurant that makes no such claims (McDonald's). Finally, the investigators~     will compare the calorie purchases from these two restaurants among youths and their families~     who eat at each of the restaurants.~   "
168700|NCT01357421|"~     This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers~     participating in an endotoxin challenge.~   "
168701|NCT01357408|"~     The purpose of the Heart Failure and Risk of re-Admissions Determined by Abnormal REVEAL~     Parameters (HF RADAR) study is to evaluate the ability of cardiac rhythm (Cardiac Compass)~     data to predict future cardiac events in heart failure (HF) patients recently discharged~     after a hospitalization for heart failure who have or plan to have a implanted loop recorder~     (ILR), specifically, the Reveal XT device. The study will enroll 40 HF patients (with LV~     function ≥ 40%) admitted to an acute care facility (observation status or hospital stay) for~     heart failure who either have a Reveal XT device in place or plan to have the ILR device~     inserted for clinical indication within 14 days of discharge from the hospitalization. HF~     patients will be followed for 6 months. Device date will be captured during normal clinic~     visits and at 6 months.~   "
168702|NCT01357395|"~     The purpose of the study is to evaluate the safety and potential benefit of combination~     amuvatinib with standard of care chemotherapy treatment (platinum and etoposide) in small~     cell lung cancer (SCLC) subjects.~   "
168703|NCT01357382|"~     Current obesity prevention emphasizes caloric restriction and avoidance of high fat foods.~     The result is an approach that replaces dietary fat with carbohydrates. There has, however,~     since been an obesity epidemic with an increased prevalence of metabolic syndrome (MetS) and~     type II diabetes. Negative results from trials of low fat diets for weight loss, prevention~     of heart disease and malignancies are consistent with the inadequacy of low fat/high~     carbohydrate approach. One of the findings of trials comparing low fat, calorie reduced diets~     to ad lib carbohydrate restricted diets is that subjects randomized to a low carbohydrate~     intake lose more weight despite equivalent intake. This equates to a 200 kcal/day greater~     weight loss on a carbohydrate restricted diet. Some investigators have speculated the~     metabolic advantage of carbohydrate restriction is due to increased energetic costs of~     gluconeogenesis. Alternatively, carbohydrate restriction is associated with increases in~     spontaneous physical activity.~      This protocol has three aims. First, adherence to a carbohydrate restricted diet in subjects~     with metabolic syndrome will cause an increase in spontaneous physical activity, independent~     of weight changes. Second, cardiometabolic risk factors (ApoB, TG, HDL, blood pressure, CRP)~     will show greater improvement on a carbohydrate restricted diet compared to a low-fat, high~     carbohydrate diet. Finally the investigators will interview a sub-sample of participants to~     better understand quality of life issues with respect to the dietary assignment or lifestyle~     intervention.~      The investigators will recruit 72 participants with MetS, from the Metabolic Syndrome Program~     at St. Paul's Hospital, Vancouver. Individuals will be randomized to either a~     low-carbohydrate diet or a calorie restricted, low fat diet and followed for 6 months. The~     investigators will measure body composition with bioelectrical impedance at baseline, 3 and 6~     months. The investigators will also examine cardiometabolic changes due to the standard~     lifestyle intervention compared to the carbohydrate restricted treatment. The investigators~     will examine blood pressure, triglycerides, LDL-chol, HDL-chol, C-reactive protein,~     apolipoprotein B, glucose, insulin, hemoglobin A1c and leptin at baseline, 3 and 6 months.~     The investigators will use accelerometers to assess changes in physical activity. The~     investigators will use three-way repeated-measures ANOVA, with changes in body weight and~     insulin levels as covariates in the model with time as the repeated factor for statistical~     analyses.~   "
168704|NCT01357369|"~     This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron)~     given routinely to pregnant women who are planning to deliver via cesarean section. The~     investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental~     transfer over time, and the subsequent metabolism of the transferred drug in the neonate.~   "
168705|NCT01357356|"~     The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray~     formulations in patients with nocturia for a total duration of 14 weeks.~   "
168706|NCT01357343|"~     This study is being conducted to compare the effectiveness of integrated chiropractic and~     acupuncture care for the management of low back pain.~   "
168707|NCT01357330|"~     Primary Objective:~      - To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s) (RP2D)~     of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or~     metastatic solid tumors.~      Secondary Objective:~        -  To characterize the safety and tolerability of SAR245408 and MSC1936369B combination~          therapy administered orally to adult patients with locally advanced or metastatic solid~          tumors~        -  To evaluate the pharmacokinetic (PK) profile of SAR245408 and MSC1936369B when used in~          combination~        -  To evaluate the pharmacodynamic (PD) effect of the SAR245408/MSC1936369B combination by~          assessing target and pathway inhibition~   "
168708|NCT01357317|"~     Objective: To examine the effects of three commonly applied treatments of disordered~     phosphorus homeostasis on biochemical markers and vascular characteristics in patients with~     moderate and advanced non-dialysis dependent chronic kidney disease.~   "
168709|NCT01357304|"~     The purpose of this study is to determine the effects of group treatment including physical~     activity referral (PAR) on level of physical activity and quality of life in patients~     diagnosed with type 2 diabetes and/or hypertension in a primary health care setting~   "
168710|NCT01357291|"~     A a multi-site trial to measure the efficacy of the Recidivism Reduction Program, a prison~     based, twenty-one module reentry program operated by the New Mexico Department of~     Corrections.~   "
168711|NCT01357278|"~     The main objective of this study is to target risk factors for falling, such as improved~     quadriceps muscle strength,balance and bone mineral density (BMD), to reduce the risk of~     osteoporotic fractures. Furthermore, to improve quality of life for patients with~     osteoporosis through an active rehabilitation program.~      Sub-goals:~        1. To assess the effect of active rehabilitation on risk factors for osteoporotic fractures~          (muscle strength, bone mineral density, balance and frequency of falling) in women with~          low bone mineral density (BMD)(t-score<1.5) and radius fracture?~        2. To assess how active rehabilitation affect the quality of life of women with low bone~          mineral density(BMD) (t-score<1.5) and radius fracture?~   "
168712|NCT01357265|"~     This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when~     administered to adult and elderly subjects.~   "
168713|NCT01357252|"~     The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd~     as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled~     with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting~     the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in~     the treatment of type 2 diabetes.~   "
168715|NCT01357226|"~     Context: Use of automated blood pressure (BP) measurement devices in the office setting is~     increasingly recognized as superior to manual BP measurement. Current recommendations are to~     have the patient alone in a quiet room, with no interactions with health care professionals~     during the readings. However, this may not be practical in primary care offices where the~     exam rooms are constantly being used.~      Objective: To compare measurements with an automated BP device in private examination rooms~     with measurements in non-private areas of a primary care office.~      Design: Randomized controlled trial with cross-over.~      Setting: Community based primary care office participating in the NorTReN Practice Based~     Research Network in Toronto, Ontario.~      Participants: Fifty consecutive consenting patients over the age of 18 having their BP~     checked as part of their routine care.~      Intervention: Patients will be randomly allocated to either automated BP measurement in an~     exam room, or in a non-private area of the clinic. After being tested in the first location~     they will subsequently be tested in the second location with the same device.~      Main outcome measure: The primary outcome measure is a comparison between the mean systolic~     values of the automated BP measurements in the two office areas. The investigators will use~     the t-test for paired samples. The secondary outcome is a comparison of systolic values for~     patients with previously documented hypertension. The investigators define a clinically~     meaningful result as a difference of 5 mmHg or more in systolic BP.~      Conclusion: New technology is more readily adopted if barriers to use are minimized. If the~     investigators find no differences in BP readings between office locations, physicians will~     then have the convenience of an additional office area to implement the automated BP~     measurement device.~   "
168716|NCT01357213|"~     This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study~     of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be~     hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the~     24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum~     monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in~     which they will receive a single intravenous infusion of active drug or placebo. Placebo will~     be normal saline. Volunteers will be followed for safety for up to 120 days after infusion~     depending on dose cohort.~   "
168717|NCT01357200|"~     This study will assess enteral feeding in an obese critically ill population with a higher~     protein whey based peptide formula.~   "
168718|NCT01357187|"~     The objective of this study is to evaluate the clinical effectiveness of AmnioFix™ in the~     reduction of the tenacity and frequency of soft tissue adhesions during the removal of~     segmental posterior lumbar instrumentation.~   "
168719|NCT01357174|"~     This study will collect demographic and safety information on the use of ROTATEQ™ in the~     Philippines.~   "
168720|NCT01357161|"~     This is a study of the safety and efficacy of MK-1775 in combination with paclitaxel plus~     carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with~     the P53 mutation. In Part 1, a small group of participants will receive MK-1775 along with~     paclitaxel plus carboplatin to establish the tolerability of MK-1775 with this combination.~     In Part 2, participants will be randomly assigned to receive either MK-1775 plus paclitaxel~     and carboplatin OR placebo plus paclitaxel and carboplatin to assess efficacy of MK-1775~     compared to placebo. The primary hypothesis of the study (Part 2) is that administration of~     MK-1775 in combination with paclitaxel plus carboplatin in participants with platinum~     sensitive p53 mutant ovarian cancer will result in improvement in progression free survival~     (PFS) per enhanced Response Evaluation Criteria In Solid Tumors version 1.1 (enhanced RECIST~     1.1) compared to participants treated with paclitaxel plus carboplatin alone.~   "
168721|NCT01357148|"~     The primary objective of this study is to obtain safety information on the use of sitagliptin~     phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists,~     internists, and general practitioners.~   "
168722|NCT01357135|"~     This is an observational study to compare the effectiveness of dual therapy of Type II~     diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine~     clinical practice in France.~   "
168723|NCT01357122|"~     This project compares the Neusidl Corneal Injector (NCI) device developed by Fischer~     Surgical, Inc. for the delivery of tissue into the eye in DSAEK surgery to the current~     standard forceps insertion DSAEK technique. The goal of this study is to examine the damage~     to the corneal endothelium resulting from the use of the NCI device in comparison to the use~     of our standard surgical DSAEK technique over time.~   "
168724|NCT01357109|"~     The purpose of the study is to investigate if oral treatment with bosentan improves~     endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy.~   "
168725|NCT01357096|"~     The hypothesis of this project is to examine whether the integrated health care program as~     the intervention group can reduce the recurrence and mortality of coronary artery-related~     diseases than the traditional one as the comparison group.~   "
168726|NCT01357083|"~     One of the main points in the biological trends is, the circadian rhythm and disturbance in~     this cycle, which cause mood disorders and irregularity in this bio clock, to get depression.~     The pineal gland with the precise regulation of circadian rhythm of melatonin regulates the~     brain haemostasis. The abnormal function of this gland gives rise to psychiatric disorders.~      In the period of youth and early of middle-age cause biochemical changes and disturbance in~     biorhythm including melatonin secretion.~      This process can change the peak of melatonin phase. In addition, a decrease in the level of~     serum melatonin, can change the function of immune system of depressed patients. This~     function facilitates the process of cancerous cell formation and tumor growth.~      With respect to the conflicting results and that the positive and negative roles of melatonin~     in the creation of depression is unknown, the aim of this study was to compare the morning~     and nocturnal serum melatonin rhythm levels in the patients with Major Depressive Disorder.~     The second purpose was to measure the morning and nocturnal serum melatonin levels in the~     depressed and healthy men and women.~   "
168727|NCT01357070|"~     Atherosclerosis is the disease process that leads to hardening of the arteries which causes~     them to become narrowed. This occurs because fat is first deposited on the inside walls of~     the arteries, then becomes hardened by fibrous tissue and calcium deposition forming a~     semi-hardened accumulation of material known as plaque. As this plaque grows, it narrows the~     channel within the artery and causes a reduction in blood and oxygen supply to the affected~     organ - such as the heart and brain. The investigators now understand that this process is~     caused by inflammation and activation of the immune cells over a period of time. It has been~     proposed that targeting these immune cells and reducing the levels of immune activation can~     protect against cardiovascular diseases.~      Previously it has been observed that consumption of fruit and vegetables rich in~     anti-oxidants can confer a protective effect against cardiovascular diseases. The use of~     anti-oxidants experimentally has shown protective benefits against activation. The~     investigators suggest that inducing anti-oxidant enzymes indirectly may be an effective means~     of providing vascular protection.~      Sulforaphane, a naturally occurring compound found in green vegetables (including broccoli,~     brussel sprouts and cauliflower) is able to protect against cell inflammatory stress by~     inducing a number of anti-oxidant molecules. Targeted studies on the consumption of broccoli~     and related vegetables have been shown to be associated with reduced risk of coronary artery~     disease.~      In the present study the investigators want to test whether the consumption of a broccoli~     smoothie containing sulforaphane can protect white blood cells from becoming activated in~     the presence of an experimental stress and how long this protective effect lasts for. To do~     this, the investigators will be analysing inflammatory changes in blood samples taken at~     different times during the study.~   "
168731|NCT01357018|"~     Chronic joint complaints are prevalent in clinical practice. If chronic arthritis such as~     rheumatoid arthritis (RA) or ankylosing spondylitis (AS) is not adequately controlled, it can~     not only affect patient's working ability but also produce indirect cost in patient's family.~     Quality of life will also be affected. Health-related quality of life issues are assuming~     increasing importance in chronic rheumatic diseases. However, studies on quality of life in~     rheumatic patients are limited. Factors related to quality of life are not clear. Application~     of quality of life measurement for improving clinical care of RA and AS patients is still~     difficult. The objective of this study was to evaluation the validity of EQ-5D life quality~     measurement in chronic arthritis patients in Taiwan. Factors associated with life quality~     will be addressed. This will also provide useful information for public health policy making.~   "
168732|NCT01357005|"~     This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications~     that propose to enrich pre-existing resources for schizophrenia in the NIMH Human Genetics~     Initiative and to apply genomic methods to further our understanding of the molecular~     etiology of the disorder. The overarching aims of this proposal are to quickly and~     cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to~     discover causal variants for the disorder in the first family-based genome-wide association~     study (GWAS) of the disorder. In Taiwan, there is no such kind of policy to support this kind~     of GWAS study as it is a very expensive study, including collecting large family samples and~     genome-wide SNP scanning. The investigators, thus, collaborate with Professor Ming T, Tsuang~     and his intended subcontracted researchers to apply for this project. The investigators, the~     research team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia.~      The investigators will meet the overarching goals of this project by accomplishing several~     Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese~     clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending~     all clinical data and biomaterials to the appropriate repositories; 3) Assess the association~     of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (SNPs) and their~     constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes such as age at onset~     ; 5) Perform a genome-wide survey for copy-number variations related to schizophrenia; 6)~     Test for gene-gene interactions (epistasis); and 7) Test for gene-environment interactions,~     such as the well-established effect of season of birth.~   "
168733|NCT01356992|"~     This non-inferiority study aims at comparing Versa® to the reference enoxaparin (Clexane®,~     Sanofi-Aventis) in patients with high-risk unstable angina and NSTEMI. The main justification~     is the search for scientific evidence to prove the Versa® effectiveness for this new~     therapeutic indication, since it is a product with potential for reducing costs, with~     effectiveness and safety comparable to the reference drug.~   "
168734|NCT01356979|"~     Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in~     the diagnosis of pleural diseases. MT has an overall diagnostic yield above 90% for malignant~     pleural diseases and pleural tuberculosis. However, others who are diagnosed as fibrinous~     pleuritis make confusion in clinicians. Whether these patients are firmly followed or not ?~     The investigators do not know the answer of this question.~      In this study the investigators aimed to investigate the outcome of the patients who are~     diagnosed as fibrinous pleuritis on MT biopsies.~   "
168735|NCT01356966|"~     Patients with chronic kidney disease have profound exercise intolerance which contributes to~     an increased risk of cardiovascular disease. The investigators have found that chronic kidney~     disease patients have an exaggerated increase in blood pressure during certain forms of~     exercise that could certainly contribute to exercise dysfunction as well as cardiovascular~     risk. The investigators will test the mechanisms underlying this exaggerated blood pressure~     response, as well as the potential benefits of short-term tetrahydrobiopterin (BH4) with~     folic acid on both exercise dysfunction and cardiovascular risk factors in chronic kidney~     disease. The investigators will test whether short-term treatment with tetrahydrobiopterin~     (BH4), a cofactor for nitric oxide, together with folic acid improves inflammation, vascular~     health, and adrenaline levels, both at rest and during exercise in chronic kidney disease.~   "
168736|NCT01356953|"~     The purpose of this study is to determine if a single session of aerobic exercise effectively~     controls the blood pressure (BP) of individuals with type 2 diabetes mellitus (T2DM) over the~     24h of post-exercise period, and the effects of intensity of aerobic exercise on these BP~     responses.~   "
168737|NCT01356940|"~     A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect~     on ambulatory activity in people with multiple sclerosis~   "
168738|NCT01356927|"~     Contraception after abortion is an important public health issue, as women who have an~     abortion are at high risk for additional unintended pregnancy. In the context of first~     trimester medical abortion, the standard of care is to administer long-acting reversible~     contraception, including the etonogestrel implant (Implanon) and depot medroxyprogesterone~     acetate (DMPA), at a follow-up appointment after the abortion.~      The investigators plan to conduct a prospective observational pilot study to evaluate the~     satisfaction of subjects who have selected either the contraceptive implant or DMPA given on~     the first day of medical abortion, as opposed to at a follow-up appointment. The~     investigators will also assess the continuation of DMPA and Implanon at 3, 6, 9, and 12~     months after the initial date of administration. In addition, the investigators will assess~     the total days of bleeding after the abortion, follow-up rate for evaluation of completion of~     medical abortion, and efficacy of medical abortion.~      A total of 40 participants will be recruited, 20 who choose Implanon and 20 who choose DMPA.~     They will be asked to fill out questionnaires during the course of the study, and will be~     followed for one year. The study duration including data analysis will be two years.~   "
168739|NCT01356914|"~     The purpose of the study is to determine whether treatment with BMS-914392 is safe, well~     tolerated and associated with a reduction of atrial fibrillation burden in patients with~     paroxysmal atrial fibrillation and permanent pacemaker.~   "
168740|NCT01356901|"~     The purpose of this observational study is to measure the real-life persistence, adherence~     and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.~   "
168741|NCT01356888|"~     The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with~     the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss~     in a non-inferiority study in de novo coronary lesions at 9 months.~   "
168742|NCT01356875|"~     Transfusional dependence has been associated closely and independently with low survival in~     patients with myelodysplastic syndrome (MDS), especially in patients at low risk according to~     IPSS. Treatment of patients with hydralazine + valproic acid as an alternative to treatment~     with 5-azacytidine has lower cost and possibly as effective with fewer side effects. The~     objective of this phase II study is to determine the effectiveness of combination therapy~     with hydralazine + Ac. Valproic compared with best supportive care. The investigators will~     select 42 patients per group, and after 14 weeks of treatment the investigators will study in~     both groups the hematological response (transfusion-dependent, hemoglobin, cytogenetics and~     morphology) and treatment safety (adverse reactions and vital signs) to 1 year after starting~     treatment. The concentration of hemoglobin, the number of transfusions, platelets,~     neutrophils and other continuous variables in both groups will be compared by Student t or~     Mann-Whitney, as appropriate. For comparison of cytogenetic and morphological response and~     other categorical variables between groups Chi square will be used. And within each group the~     investigators will compare each of these variables before and after treatment by t-test for~     paired data or Wilcoxon test.~   "
168743|NCT01356862|"~     The principal morbidity following axillary node dissection within the scope of breast cancer~     surgery is the post-operative development of lymphocele. According to the literature,~     incidence can vary from 4 to 89% depending on the type of surgery, whether or not a drain is~     inserted or a compression dressing applied and the time at which the drain is removed… In our~     experience, the incidence is 40% [IGR (Gustave Roussy Institute) data focusing on 70 patients~     between November 2008 and February 2009]~      Encouraging results in terms of reducing postoperative lymphoceles as well as drainage~     duration and volume using Octreotide have been recorded in two recent studies. A new molecule~     developed by Novartis Laboratories, namely pasireotide, is a somatostatin analog possessing~     strong affinity for several somatostatin receptors (30 to 40 times greater for sst1 and sst5,~     5 times greater for sst3 and equivalent for sst2)~      The purpose of this trial is to assess the efficacy of a pre-surgical injection of~     pasireotide LAR in reducing the postoperative incidence of symptomatic lymphoceles following~     axillary node dissection.~      The secondary objectives are to assess the efficacy of prolonged release pasireotide on the~     duration of postoperative drainage, the daily drainage volume, the total drainage volume, the~     number of repeated lymphocele aspirations and the volume, the total volume of lymph~     aspirated, the incidence of postoperative febrile episodes, the length of hospital stay, and~     the length of time to onset of adjuvant chemotherapy. It is also to assess the safety of~     prolonged release pasireotide.~      The primary objective of this study is to assess the efficacy of a preoperative prolonged~     release pasireotide injection in the reduction in the incidence of symptomatic, postoperative~     axillary lymphoceles following mastectomy-axillary node dissection.~   "
168744|NCT01356849|"~     Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study. The objective of~     the study is to evaluate the efficacy and safety of once daily administration of atrasentan~     tablets (low dose and high dose) compared to placebo in reducing residual albuminuria in Type~     2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose~     of a Renin Angiotensin System (RAS) inhibitor. If the patient is already receiving a maximum~     tolerated labeled daily dose of RAS inhibitor and a diuretic, he/she will complete 4 weeks of~     the Run-in Period on a dose that has not been adjusted. If the patient is currently not~     receiving a maximum labeled daily dose of a RAS inhibitor then the dose will be titrated up~     to the maximum tolerated labeled dose over the course of 4 to 8 weeks during the Run-in~     Period. It is expected that subjects not receiving a diuretic will have a diuretic added or~     titrated during this period to maximize RAS inhibition. Following titration to the maximum~     tolerated labeled dose, the patient will complete an additional 4 weeks of Run-In Period on~     an unchanged doses of RAS inhibitor and diuretics, unless medically contraindicated. The~     randomization will be stratified based on country where subjects are enrolled into the study,~     and the Week -1 Urinary Albumin to Creatinine Ratio (UACR) levels (< or = 1000 mg/g [113~     mg/mmol], or > 1000 mg/g [113 mg/mmol]). Within each stratum, subjects will be randomly~     assigned in a 1:2:2 ratio to one of the following blinded treatment groups: Group A - Placebo~     once daily (QD) Group B - low dose atrasentan QD Group C - high dose atrasentan QD After the~     12 weeks of study drug treatment, subjects will be followed up to 30 days.~   "
168745|NCT01356836|"~     Collateral growth and coronary angiogenesis are chronic adaptations to myocardial ischemia.~     Collateralization helps to restore blood flow and as a result salvages myocardium in severely~     ischemic myocardial regions. Thus, good collateral development in patients with severe~     coronary artery disease (CAD) improves ventricular function and prognosis (1-3).~      However, coronary collateral development is different among patients even with similar~     degrees of coronary artery stenosis. Several factors, such as diabetes mellitus (4) and~     duration of myocardial ischemic symptoms (5) have been reported to effect coronary collateral~     development. At the cellular level, inflammatory cells, especially monocytes have an~     important role in collateralization. In a series of experimental studies with animals, it has~     been shown that monocytes are important elements for development of collateral vessels (6-7).~     In a recent study, it has been demonstrated that increased circulating monocyte count is~     related to good collateral development in patients with stable coronary artery disease (8).~      Monocytes in human blood are heterogeneous and can be classified into two subsets according~     to the presence or absence of the FcγRIII receptor CD16 (9): CD14++CD16- monocytes~     characterized by high level expression of the CD14 cell surface receptor but no expression of~     CD16 receptor, and CD14+CD16+ monocytes characterized by the co-expression of CD16 receptor~     with either high or low level expression of the CD14 receptor. These subsets differ in~     function and response to several cytokines.~      Our aim in this study was to find out any possible relationship between the levels of~     circulating monocyte subsets and coronary collateral development.~   "
168746|NCT01356823|"~     This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine~     expressed in E. coli.~      The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce~     higher antibody and at the same time caused less adverse events.~      The secondary purpose of this study is to to evaluate the safety and immunopersistence of the~     study vaccine.~   "
168747|NCT01356810|"~     Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course~     which is presented in 15 to 20% of patients admitted to general wards. It is a potentially~     life - threatening complication which can be prevented. It is the objective of this~     randomized controlled trial to evaluate whether a multicomponent environmental intervention~     could reduce the incidence of delirium in a general medical ward.~   "
168748|NCT01356797|"~     Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia~     technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been~     validated for this surgery. Both selective techniques are specially indicated for ambulatory~     surgery because of PACU fast track, low discharge home time and high patient satisfaction.~     This study compares both spinal techniques for knee arthroscopy surgery.~   "
168750|NCT01356771|"~     The investigators are conducting a study to provide evidence about the comparative~     effectiveness of mailed, tailored intervention materials on cancer prevention behavioral~     outcomes. The investigators will send out three (3) tailored mailings for participants who~     are assigned to the intervention group. Second, during the eligibility screening, the~     investigators will be assessing the relative yield and functioning of two risk assessment~     tools (BRAT and FEARS) on determining an individual's level of risk for skin cancer.~   "
168751|NCT01356758|"~     Psoriasis is a common inflammatory disease of the skin and joints with a prevalence of 1-3%~     in the caucasian population of Northern Europe and the US. Similarly to other inflammatory~     diseases there is now substantial and accumulating evidence that psoriasis has a systemic~     inflammatory component.~      It is known that patients suffering from psoriasis have increased prevalence of traditional~     cardiovascular risk factors, such as hypertension, dyslipidaemia, obesity, tobacco use and~     diabetes mellitus. This would logically explain an increased rate of cardiovascular events,~     but even when adjusting for theses risk factors, psoriasis carry an independent risk for~     developing cardiovascular disease.~      Recent large epidemiological studies have shown a strong correlation between psoriasis and~     myocardial infarction.~      Atopic dermatitis has been linked to ischemic stroke in one study, but besides this, the~     disease has not been associated with cardiovascular disease.~      In conclusion, convincing and increasing evidence is supporting that psoriasis induce~     accelerated atherosclerosis and hence cardiovascular disease and mortality. In particular,~     this is seen in young patients with early disease onset.~      Psoriasis is believed to be driven by cytokines produced by Th1 and Th17 lymphocytes. A~     number of these cytokines are suggested to be atherogenic. In contrast, another chronic~     inflammatory disease, atopic dermatitis, is predominantly driven by Th2 lymphocyte derived~     cytokines, some of which may inhibit atherosclerotic processes. It is therefore, of interest~     to compare the presence of cardiovascular disease in these two inflammatory skin diseases.~      Hypothesis: That the risk of developing cardiovascular disease and especially coronary artery~     disease is increased in psoriasis patients and that this process can be influenced by~     treatment of psoriasis with biological treatment.~   "
168752|NCT01356745|"~     Less than 10% of patients with a traumatic pain have been managed by a physician before to be~     admitted in an emergency service. 50 % of those patients have been carried by paramedics.~     Premixed nitrous oxide and oxygen is often used by paramedics, but no scientific studies have~     demonstrated its efficacy. The aim of the study is to demonstrate the efficacy of premixed~     nitrous oxide and oxygen in patients with out-of-hospital moderate acute pain.~   "
168753|NCT01356732|"~     Mechanically ventilated patients experiencing pain are frequent in intensive care units (ICU)~     however their treatment remains unclear. This prospective pharmacodynamic study relates to~     the analgesia of procedural pains. The primary objective was to determine the 90% effective~     dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral~     Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically ventilated~     patients.~      Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation,~     reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were~     included.~      During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of~     sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new~     LD until BPS was at 3 or 4.~   "
168754|NCT01356719|"~     Tracheostomies are artificial airway devices inserted into the neck. They can become~     displaced and lead to patient harm. Other than external visual inspection, there is no~     currently described system for describing the position of a tracheostomy tube within the~     airway. The investigators propose to undertake endoscopic inspection of the tracheostomy tube~     with a small fibre-optic camera from above and also through the tube to visualise its~     position within the airway. The investigators will take anonymised paired images and then~     score these using 6 different scoring systems. The investigators will determine which scoring~     system provides the simplest and most reproducible scores between 6 blinded assessors. A~     clinically useful scoring system could be used in future to predict problems with~     tracheostomy positioning.~   "
168755|NCT01356706|"~     Only few reports exist on long-term survival after minimally invasive liver surgery (MILS for~     colorectal liver metastases. No data are available assessing prognostic factors in the era of~     current modern treatment strategies. The aim of the current study is to analyze the long-term~     oncologic outcome after MILS for metastases from colorectal cancer and determine prognostic~     indicators.~   "
168756|NCT01356693|"~     Cough is the most bothersome symptom for patients with the common cold.~      The objective of the study is to compare the phytotherapic Bromelin, a compound preparation~     of honey from the bee apis mellifera with the extract of the pineapple (Ananas comosus) with~     placebo in reducing cough episodes in patients with the common cold.~   "
168757|NCT01356680|"~     This study is designed to test the non-inferiority of the experimental arm compared to the~     standard arm in terms of progression free survival (PFS).~   "
168758|NCT01356667|"~     Drum-Assisted Recovery Therapy for Native Americans (DARTNA) is an R-21 NIH/NCCAM-funded~     study aimed to complete the development and pilot a new substance abuse treatment protocol~     utilizing drumming for American Indians/Alaska Natives with substance use disorders. The~     study includes activities to complete the protocol, followed by a randomized-controlled~     clinical trial.~   "
168759|NCT01356654|"~     This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the~     recovery of postural control in stroke rehabilitation.~   "
168760|NCT01356641|"~     Appendectomy for acute appendicitis has recently been questioned as being the only correct~     treatment for appendicitis. Appendectomy has been reported to have significant early and late~     morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of~     life and lower costs have been associated with antibiotic treatment alone. Five clinical~     trials in selected patients (males, older than 18 years) comparing appendectomy and~     antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone~     is safe and effective in 48-95% of the patients Conclusive evidence with regard to the~     efficacy of antibiotic treatment alone in children with proven acute appendicitis however is~     lacking. We propose a prospective cohort study to answer the following questions:~   "
168761|NCT01356628|"~     This is a Phase 2 Study of PD-0332991 in the treatment of patients with Advanced~     Hepatocellular Carcinoma (HCC), a type of adenocarcinoma and the most common type of liver~     tumor. PD-0332991 is a compound that stops the tumor cell from entering the Synthesis phase~     of the cell cycle, therefore stopping DNA multiplication and decreased tumor cell copying.~   "
168762|NCT01356615|"~     Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as~     anticoagulation during hemodialysis (HD) therapy. In this study the investigators have~     compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.~   "
168763|NCT01356602|"~     This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison~     to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent~     flares of acute gouty arthritis.~   "
168765|NCT01356576|"~     The purpose of this study is to determine if there is a drop in platelet count after~     hemodialysis. Hemodialysis membranes are known to activate complement and cause a drop in~     platelets and sometimes in white blood cells. The investigators are going to study one of the~     membranes which is the Fresenius Optiflux® to check if it causes a drop in platelets.~   "
168766|NCT01356563|"~     The investigators propose that pharmacist interventions would reduce the amount of unresolved~     medication-related problems in hemodialysis patients.~      Condition:Hemodialysis patients~      Intervention:Behavioral,Pharmacist intervention~      Study Design:Randomized Allocation~      Control: Active Control~      Endpoint Classification: Efficacy Study~      Intervention Model: Parallel Assignment~      Masking: Double Blind (Caregiver, Outcomes Assessor)~      Primary Purpose: Treatment~   "
168767|NCT01356550|"~     This open-label, single-dose, parallel group study will assess the pharmacokinetics and~     safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic~     hepatic impairment. Patients and healthy volunteers will receive a single oral dose of~     RO4917838.~   "
168768|NCT01356537|"~     The purpose of this study is to proof increasing patient satisfaction and preservation of~     quality of life in patients with Gaucher's Disease receiving their enzyme replacement therapy~     with VPRIV (Velaglucerase alfa)at their home setting compared to receiving the infusions at~     the clinic or at doctor's practice.~   "
168769|NCT01356524|"~     In Assisted Reproductive Techniques (ART) there is a need for luteal support using~     progesterone, estrogen and probably human chorionic gonadotropin (HCG). The optimal route of~     administration and dose has not yet been determined.~      The aim of the study is to investigate whether high levels of mid-luteal serum progesterone~     are related to higher pregnancy rates in ART cycles. We also plan to investigate whether~     using higher doses of vaginal progesterone results in higher pregnancy rates.~   "
168770|NCT01356511|"~     The project was undertaking by Qilu Hospital of Shandong University and other 11 well-known~     hospitals in China. In order to report the efficacy and safety of high-dose dexamethasone~     compared to conventional dose prednisone for the first-line treatment of adults with primary~     immune thrombocytopenia(ITP).~   "
168771|NCT01356498|"~     This is an open-label extension phase of two double-blind, placebo-controled Phase 3~     protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic~     gout. The purpose of this study is to provide a continuation of treatment to subjects~     completing the double-blind studies and obtain long-term safety and efficacy data.~   "
168772|NCT01356485|"~     Sickle Cell Anemia is caused by an inherited hemoglobin disorder. Healthy red blood cells are~     discoid and can deform and move through small blood vessels to carry oxygen to all parts of~     the body. In sickle cell disease, as red blood cells circulate and oxygen is released in the~     circulatory system, the deoxygenated abnormal hemoglobin S can begin to polymerize. When this~     occurs, the red blood cells can become sticky and elongated. These sickled red blood cells~     are less flexible and will obstruct small blood vessels and block normal red blood cells from~     traveling through the circulatory system, which limits oxygen delivery to tissues and organs.~     This is known as a sickle crisis.~      Patients suffering from a sickle crisis experience severe pain and are at risk of stroke,~     heart attack or even death. By lowering the level of oxygen pressure at which sickling occurs~     and opening the vasculature and rapidly delivering oxygen directly to ischemic tissues, the~     addition of MP4CO to existing treatment protocols may alleviate pain associated with a sickle~     cell crisis, abort a crisis and/or potentially reduce the duration of a crisis. This could~     mean less time in the hospital and an improved quality of life for patients with sickle cell~     anemia.~   "
168773|NCT01356472|"~     As previous studies showed that the synergy between linezolid and carbapenem in vitro and in~     vivo (animal studies), our study is aim to investigate the activity of linezolid, alone and~     in combination with carbapenem against methicillin-resistant Staphylococcus aureus (MRSA) in~     ventilator-associated pneumonia (VAP) patients.~   "
168774|NCT01356459|"~     The study is designed as a randomised controlled trial of trauma patients admitted to the~     Royal Melbourne Hospital (RMH) Emergency Department (ED) and subsequently transferred to the~     Intensive Care Unit (ICU). Patients meeting the study inclusion criteria will be randomly~     allocated to either the control group that will receive usual pressure ulcer prevention~     strategies or the trial group that will receive usual care plus have a Mepilex Border Sacrum~     dressing applied to their sacrum and Mepilex Boarder Heel dressing applied to each heel in~     the ED.~      Hypothesis:Patients treated with Mepilex Border dressings will have a lower incidence rate of~     sacral and heel pressure ulcer development than patients receiving standard care.~   "
168775|NCT01356446|"~     The study investigates the impact of the implementation of a surgical checklist on the~     mortality 30 days and 90 days after surgery. Patients scheduled for elective surgical~     procedures (excluding cardiac surgery) lasting at least 15 minutes are eligible. Surgery is~     performed in a single tertiary care center. The study is an open trial before and after~     intervention (implementation of the checklist safe surgery saves lifes).~   "
168776|NCT01356433|"~     Subclinical inflammation is a common phenomenon in patients receiving maintenance~     hemodialysis (MHD). This is because various pro-inflammatory cytokines are promoted due to~     metabolic acidosis, volume overload, and / or non-sterile dialysate.~      As important antioxidants, vitamin C was prominently consumed by oxidative stress and~     inflammation. So patients receiving dialysis therapy usually had a low plasma vitamin C~     level.~      It was documented that inflammation was associated with increased risk of cardiovascular~     morbidity and mortality in patients on dialysis. But the relationship between plasma Vitamin~     C and each of inflammatory markers and prealbumin was lacking. Because vitamin C had~     anti-inflammation effect on behalf of its electron receiving ability, the investigators made~     a hypothesis that vitamin C supplementation can reduce inflammation status in patients on~     maintenance dialysis~   "
168798|NCT01356147|"~     To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator~     associated pulmonary infections. Dornase alfa has been effective in the treatment of~     pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The bacteria~     causing pulmonary infections in cystic fibrosis patients is similar to those infecting~     preterm infants. The investigators expect that dornase alfa therapy will improve recovery~     from ventilator associated pulmonary infections in preterm infants.~   "
168777|NCT01356420|"~     The purpose of this study is to learn about Smith-Lemli-Opitz Syndrome (SLOS). SLOS is an~     inherited condition that is caused by the body not making an enzyme as it should. The body~     needs the enzyme to help make cholesterol. SLOS can cause many health problems including slow~     growth and development, eating disorders, sleep disorders, behavior disorders, and eye~     diseases. Severe SLOS leads to birth defects and mental retardation and in many cases early~     death. The investigators plan to measure cholesterol and other sterol levels, perform~     clinical observations, whole body testing and imaging (brain MRIs), to learn more about the~     disease and its progression, differences in the clinical features among individuals with~     SLOS, and look at the effect of cholesterol supplementation in this condition.~      The study is an interventional study to characterize disease progression and correlations~     between clinical, biochemical and physiological features of the disease. The main hypothesis~     is that dietary cholesterol supplementation does not improve features of SLOS related to the~     brain (e.g. IQ, behavior).~   "
168778|NCT01356407|"~     Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or~     polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its~     effectiveness, tolerability and safety.~   "
168779|NCT01356394|"~     Metabolic syndrome (MS) is a clustering of risk factors for cardiovascular disease (CVD) such~     as hypertension, hypertriglyceridemia, low HDL-cholesterol levels, disorders of glucose~     metabolism, and insulin resistance. A number of associated conditions are included in the MS~     spectrum such as abdominal obesity, systemic inflammatory activation, endothelial~     dysfunction, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome,~     and microalbuminuria. As a consequence, the diagnosis of MS identifies patients who are at~     increased risk for type 2 diabetes mellitus and CVD. In the last few years, the potential for~     MS to trigger renal damage and accelerate the progression of pre-existing nephropathy has~     become a focus of research. Some studies have suggested that MS can influence the development~     of CKD, although the underlying mechanisms are not well understood. In this study, the~     investigators hypothesized that modifying a key component of the MS, namely obesity, could~     attenuate renal damage. The investigators examined the impact of weight loss on creatinine~     clearance and urinary albumin excretion in non-diabetic obese patients with MS.~   "
168780|NCT01356381|"~     The study will demonstrate the effect of 24 weeks of treatment with vildagliptin compared to~     placebo on insulin sensitivity in patients with type 2 diabetes mellitus (T2DM) treated with~     metformin, assessed as glucose Rd (rate of glucose disposal) during a hyperinsulinemic~     euglycemic clamp.~   "
168781|NCT01356368|"~     The study aims at piloting the concept of customization of chemotherapy based on molecular~     markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤~     2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or~     compare individual regimen but rather it will test the approach of customization concept as a~     whole.~      The results of this pilot study will help in designing more definitive trials in our patient~     population.~   "
168782|NCT01356355|"~     The purpose of this study is to compare the efficacy and safety of the Ayurvedic formulation~     ,Herbmed Plus against placebo and anti-cholinergic drugs in relieving the ureteral stent~     discomfort.~   "
168783|NCT01356342|"~     This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects~     aged between 6 months old to 18 years old. All participants will be divided into three age~     cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL~     vaccine separated by 4 weeks. Second, participants aged 3 through < 9 years will receive 2~     doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through < 18 years~     will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the~     time of vaccination, solicited local and systemic reactions within 7 days after each~     vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood~     samples will be collected from each subject immediately prior to, and 4 weeks after each~     vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO~     haemaglutination inhibition reference technique. The analysis will be observer-blinded. All~     participants will be followed, either by clinical visit or by telephone contact, for 6 months~     after the first vaccination for safety reasons.~   "
168784|NCT01356329|"~     Prophylactic treatment will start from surgery until the patients are discharged from the~     hospital(18). Then each patient will have 2 follow up visit in gyne- oncology clinic. The~     first visit will be 2 weeks from discharge & the second visit will be 3 months after surgery.~     In each visit patient will be evaluated for any evidence of thrombo-embolic events clinically~     & radiologically if needed ( spiral CT, V/Q scan & lower limp Doppler ). Any side effect or~     adverse reaction will be reported & it will be evaluated if it is related to the drug used or~     not.~   "
168785|NCT01356316|"~     Each potential subject will be screened before the start of the study to determine their~     eligibility for participation. Just prior to vaccination, a 10 mL venous blood sample will be~     taken from each eligible subject, for baseline titration of circulating anti-HA antibodies.~     Immediately thereafter, each subject received one dose of vaccine (0.5 mL) by intramuscular~     injection into the upper arm. Subjects will be asked to stay at the site for 30 minutes~     post-vaccination to observe for immediate reaction. Subjects will be monitored for adverse~     events during the study. At three weeks (±3 days) after the vaccination, subjects will be~     asked to return to the site for final collection of blood samples.~   "
168786|NCT01356303|"~     This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients~     with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical~     City, Riyadh.~      Sub-sites will be open for patient accrual in selected centers in the Kingdom.~   "
168799|NCT01356134|"~     The investigators propose that evidence of chronic cerebrospinal venous insufficiency (CCSVI)~     may be evident in the vasculature of the fundus. The investigators will be examining fundi of~     multiple sclerosis patients and Ehlers-Danlos patients to see if evidence of CCSVI can be~     found in these patients having high risk for CCSVI. The investigators will read the fundus~     photos, compared to age-matched normals in a blind fashion.~   "
168800|NCT01356121|"~     To compare effects of sedation for upper gastrointestinal endoscopy with propofol and~     midazolam on psychometric tests and critical flicker frequency (CFF) in cirrhotics~   "
168787|NCT01356290|"~     Patients with relapsed medulloblastoma have a very poor prognosis whether treated with~     conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or~     combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment~     option in solid malignancies. The frequent, metronomic schedule targets both proliferating~     tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators~     will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs~     (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide~     and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and~     liposomal cytarabine. The aim of the study is to extend therapy options for children with~     recurrent or progressive medulloblastoma, for whom no known curative therapy exists, by~     prolonging survival while maintaining good quality of life. The primary objective of the~     MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these~     heavily pretreated children and young adults. Additionally, progression-free survival (PFS),~     overall survival (OS), as well as feasibility and toxicity will be examined.~   "
168788|NCT01356277|"~     The broad aim of the proposed study is to improve medication adherence in adolescent kidney~     transplant recipients. The investigators hypothesize that a multi-component intervention will~     improve medication adherence in the adolescent kidney transplant population. The specific~     aims are to determine, in a randomized clinical trial, the efficacy of a structured,~     multi-component intervention in improving adherence to anti-rejection medications and graft~     outcomes, and to identify characteristics of healthcare systems that are independently~     associated with adherence.~   "
168789|NCT01356264|"~     Despite advances in surgical care, the incidence of postoperative complications and prolonged~     recovery following colorectal surgery remains high. Efforts to improve the recovery process~     have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural~     blockade) and post-operative periods (eg, fast track early nutrition and mobilization. The~     pre-operative period may in fact be a better time to intervene in the factors that contribute~     to recovery. The process of enhancing functional capacity of the individual in anticipation~     of an upcoming stressor has been termed prehabilitation. Based on the notion that~     preoperative exercise would have an impact on recovery of functional capacity after~     colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup~     analysis identified that patients whose functional exercise capacity improved preoperatively,~     regardless of exercise technique, recovered well in the postoperative period. However,~     one-third of patients deteriorated preoperatively despite the exercise regimen, and these~     patients were also at greater risk for prolonged recovery after surgery. These results~     suggested that exercise alone is not sufficient to attenuate the stress response in all~     patients. In the present trial, the impact of a multimodal prehabilitation intervention~     composed of exercise, nutritional supplement and psychological well-being begun in the~     preoperative period will be compared to one begun in the postoperative period.~   "
168790|NCT01356251|"~     The aim of this study is to learn about how mesothelioma affects patients' emotional and~     physical well-being. Also, the investigators would like to learn more about what patients~     need and how they deal with this illness. This information can help us find ways to lessen~     physical and emotional strains. Part of the study tests an alternate way of giving emotional~     support through the Internet. By providing support online, patients can participate in the~     comfort of their home.~   "
168791|NCT01356238|"~     Quality-controlled commercial media have been used in many in-vitro fertilization (IVF)~     laboratories. However, commercial media are costly and difficult to compare directly because~     their exact compositions are not clearly indicated. Although commercially available media~     have commonly been used in most IVF programs worldwide, there are several advantages to the~     use of in-house synthetic sequential media at IVF laboratories. First, the results of quality~     control should be reliable due to a stringent protocol setting-up. Second, any direct~     supplementations or deletions of specific components are feasible to obtain good quality~     embryos and high pregnancy rates since those components can be defined. Finally, dependence~     on commercially available media diminishes so that the laboratory can more easily accommodate~     unexpected situations or problems, such as a sudden increase in IVF patients. Therefore, the~     present study was conducted to compare the efficacy of in-house MRC media in the human~     IVF-embryo transfer (ET) program to that of commercially available media.~   "
168792|NCT01356225|"~     The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN)~     administration of ketorolac after dental impaction surgery.~   "
168793|NCT01356212|"~     This was a randomised three-way crossover design study. The study consisted of three study~     periods each separated by a minimum 44 hour washout period. During the course of each study~     period, scintigraphic images were acquired at planned intervals after dosing. Subjects were~     able to leave the clinical unit after the completion of study specific procedures at 6 hours~     post-dose.~      The primary objective of the study was to determine whether any of the radiolabelled~     ketorolac formulation was deposited in the lungs of healthy volunteers following nasal~     inhalation under three different conditions (gentle sniff-inhalation with subject standing,~     vigorous sniff-inhalation with subject standing, gentle sniff-inhalation with subject~     semi-supine). The secondary objectives were to determine the deposition pattern of~     radiolabelled ketorolac solution in the nasal cavity, and clearance of the radiolabel over a~     six-hour period.~   "
168794|NCT01356199|"~     The purpose of this study is to determine whether the nutritional supplement ARTRONAT~     improves the quality of life of patients with osteoarthritis.~   "
168795|NCT01356186|"~     The broad objective of this research is to effectively utilize a unique window of opportunity~     during the hospitalization period following a recent suicide attempt to deliver a brief and~     targeted intervention for traumatized individuals.~   "
168796|NCT01356173|"~     This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety,~     tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO).~   "
168797|NCT01356160|"~     This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response~     Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a~     and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus~     Infection.~   "
168801|NCT01356108|"~     The purpose of this registry is to retrospectively and prospectively obtain clinical data in~     consecutively treated patients, in order to demonstrate that the commercially available~     Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for~     patients with pulmonary regurgitation or stenosis.~   "
168802|NCT01356095|"~     Despite increased emphasis on evidence based practice in recent years a gap remains between~     evidence and practice, particularly in resource poor countries. Few studies to date have~     examined the use of knowledge translation strategies to improve health care outcomes in low~     income countries. However, given that the majority of health care in these settings is~     provided by workers with less training and limited resources, the theoretical potential for~     knowledge translation strategies to improve health care delivery and outcomes by integrating~     best evidence into routine practice may be greatest in these settings.~      Knowledge translation (KT) is an approach to changing health care provider behavior to reduce~     the gap between evidence and practice in health care delivery. There has been a tendency for~     knowledge translation interventions to employ generic, off the shelf, strategies, and apply~     them to deal with specific issues. This generic approach, fails to recognize the variability~     in the specific characteristics of health care settings, in terms of their patient~     populations, health care systems, and health care providers. These characteristics, whether~     they function as barriers or facilitators to change, make a generalized approach to KT~     ineffective, where a tailored strategy, which specifically adjusts its approach to measured~     local barriers and facilitators may achieve better alignment of practice to evidence. This is~     likely to be particularly true in low income countries where the majority of health care is~     provided by non-physician health care workers, working within a wider range of health care~     systems, with variable and unique patient populations and resource constraints. Given the~     potential to significantly impact health care outcomes at relatively low cost, further~     research is needed both to develop methods for identifying potential barriers and~     facilitators to KT strategies in specific resource poor settings, and to evaluate the~     effectiveness of KT strategies tailored to address the identified barriers.~      This study will assess the effectiveness of a two part knowledge translation intervention~     tailored to address factors identified in a previous study as functioning as barriers and~     facilitators to treatment adherence among patients on treatment for tuberculosis or combined~     tuberculosis and antiretroviral treatment, targeting improved patient adherence and health~     outcomes, in a specific low income country.~   "
168803|NCT01356082|"~     A newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™~     Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) provides beat-to-beat BP readings~     and is non-invasive. To make sure that anaesthesiologist can rely on and make clinical~     decisions based on values provided by the CNAP™ monitor, to demonstrate its reliability we~     will test it during the perioperative care of children.~   "
168804|NCT01356069|"~     Subjects affected with severe Borderline Personality Disorder (BPD) are often heavy users of~     Mental Health Services (MHS). This study evaluates the efficacy of the addition of Sequential~     Brief Adlerian Psychodynamic Psychotherapy (SB-APP) to the treatment-as-usual (TAU) for BPD~     compared to the TAU alone for a naturalistic group of heavy MHS users with BPD. The efficacy~     was evaluated after at 6 time points along a two years of follow-up.~      Thirty-five outpatients eligible for the study were randomly assigned to two treatment groups~     (TAU=17; SB-APP=18). The Clinical Global Impression (CGI) and the CGI-modified (CGI-M) for~     BPD, the Global Assessment of Functioning (GAF), the State-Trait Anger Expression Inventory~     (STAXI), and the Symptom Checklist-90 Revised (SCL-90-R) were administered at T1, T3, T6,~     T12, T18, and T24. At T12 also the Working Alliance Inventory-Short Form (WAI-S) was~     filled-in by participants and compared between groups. In the one-year follow-up the SB-APP~     group did not receive any individual psychological support. MHS was specifically trained in~     BPD treatment and had regular supervisions.~      Scores of the CGI, GAF, and STAXI improved after 6 and 12 months, irrespective of treatment.~     SB-APP group displayed a better outcome for impulsivity, suicide attempts, chronic feelings~     of emptiness and disturbed relationships. The results displayed a good stabilization during~     follow-up year even after the interruption of psychotherapy in the SB-APP group.~      Even though the TAU for BPD applied to heavy MSH users displayed some efficacy in reducing~     symptom expression and improving global functioning, the adjunct of a specific time-limited~     and focused psychotherapeutic treatment reached a better outcome. In particular the~     possibility of a focus on patients' personality functioning (SB-APP) with a specific~     psychotherapeutic approach seemed to be more effective than the general support to social~     impairment offered by the TAU approach.~   "
168805|NCT01356056|"~     The purpose of this research study is to design, implement, and clinically assess a portable,~     user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard~     in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective,~     qualitative ranking system. The main goal of this research is to develop a quantitative~     system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a~     home based system which can capture those symptom changes over the course of a day and aid in~     evaluating treatment protocol efficacy.~   "
168806|NCT01356043|"~     The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of~     S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine~     monotherapy.~   "
168807|NCT01356030|"~     The two most commonly used methods to biopsy suspected pancreaticobiliary masses are (1)~     endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) and (2) cytology brush biopsies~     obtained during endoscopic retrograde cholangiopancreatography (ERCP). At most centers, the~     specific method used depends on the availability of the technology and local expertise.~     Although it is believed that EUS-FNA is more accurate than ERCP brushings, there have been no~     head-to-head comparisons. The investigators' hypothesis is that EUS-FNA is superior to ERCP~     in obtaining tissue biopsies of pancreaticobiliary tumors, and the investigators aim to~     directly compare the two techniques.~   "
168808|NCT01356017|"~     The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of~     Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan~     monotherapy.~   "
168809|NCT01356004|"~     Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis~     may be difficult and cyclosporine can induce some remission.~      The investigators hypothesized that the combined use of live attenuated varicella vaccine as~     an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis~     can give positive responses.~   "
168810|NCT01355991|"~     To determine the acute and chronic effects of a short course of treatment on spinal cord~     injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂~     agonist (Salmeterol) on:~        -  Fraction of expired NO (FeNO)~        -  Selected Biomarkers of inflammation in exhaled breath condensates (EBC)~        -  Pulmonary function, as measured by pulmonary function tests and body plethysmography~   "
168811|NCT01355978|"~     When using the Breathe Technologies Ventilation System during simulated activities of daily~     living (ADLs), Subjects with moderate-to-severe chronic obstructive pulmonary Disease (COPD)~     will be comfortable and report acceptability.~   "
168812|NCT01355965|"~     To determine the safety and manufacturing feasibility of IV autologous chimeric immune~     receptor (CIR) T cells transfected with anti-mesothelin messenger RNA (mRNA) expressing a~     single chain antibody variable fragment linked to the intracellular CD 3 zeta T cell receptor~     domain and the 4-1BB costimulatory domain.~   "
168872|NCT01355159|"~     The hypothesis of the study is: high dose (4.0 mg per day) supplementation for pregnant women~     at high risk of developing preeclampsia starting in early pregnancy and continued throughout~     the entire pregnancy will lower the incidence of preeclampsia.~   "
168813|NCT01355952|"~     The aim of this study is to collect pilot data to compare the effectiveness of treatment with~     Alpha Lipoic Acid (ALA) for reduction in body weight in 40 obese outpatients with~     schizophrenia or schizoaffective disorder in an open-label pilot trial. The investigators~     also plan to test the feasibility of utilizing ALA as a weight loss agent for obese~     outpatients with schizophrenia or schizoaffective disorder in terms of tolerability,~     schizophrenia symptoms, cognition and side effects. We have run a total of 12 non-diabetic~     participants and are now recruiting diabetic patients in hopes of comparing the two groups.~   "
168814|NCT01355939|"~     The proposed study will compare the benefits, harms, and comparative effectiveness of~     intraperitoneal barrier-coated and non-barrier coated ventral hernia repair (VHR) mesh in~     reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual~     patient subpopulations and clinical circumstances. A subset of the data will be analyzed to~     compare the benefits, harms, and comparative effectiveness of the laparoscopic and open~     approaches to adhesiolysis. A comprehensive array of health-related risk factors and~     patient-centered outcomes will be assessed in the investigators diverse patient population~     for proper multivariate data analysis.~      Specific Aim I: To evaluate and compare the adhesion characteristics of intraperitoneal~     barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior~     ventral hernia repair.~      Specific Aim II: To evaluate and compare the adhesion-related complications and~     adhesiolysis-related complications of intraperitoneal barrier-coated versus~     non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair.~      Specific Aim III: To determine the comparative effectiveness of intraperitoneal~     barrier-coated versus non-barrier-coated ventral hernia repair mesh in reducing adhesions,~     adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations~     and clinical circumstances.~      Specific Aim IV: To evaluate and compare the adhesiolysis-related complications of the~     laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior~     ventral hernia repair.~      Specific Aim V: To determine the comparative effectiveness of the laparoscopic and open~     approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia repair.~   "
168815|NCT01355926|"~     The purpose of this study is to help us to better understand the effects of two different~     types of surgical techniques on pain and quality of life in patients with precancerous~     lesions or early stage mouth cancers.~   "
168816|NCT01355913|"~     In myelodysplastic syndromes (MDS) the knowledge about chromosomal aberrations is important~     for diagnosis, pathogenesis, prognosis and treatment. Usually, chromosomal anomalies in MDS~     patients are detected in bone marrow cells by chromosome banding analyses of metaphases.~     Alternatively or additionally they can be diagnosed by Fluorescence-in-Situ-Hybridization~     (FISH). The investigators here present a novel method for cytogenetic monitoring of MDS~     patients from peripheral blood which is representative for the clone size in bone marrow~     cells. The purpose of this prospective multicenter non-interventional diagnostic study is to~     detect and to follow chromosomal aberrations from peripheral blood closely, to assess~     karyotype evolution, to detect rare abnormalities and to correlate the molecular-cytogenetic~     results with peripheral blood counts, bone marrow morphology and treatment modalities and~     responses.~   "
168817|NCT01355900|"~     Different strategies of tourniquet application during elective primary total knee~     arthroplasty are thought to be associated with different outcomes. In that context, the study~     investigates different tactics in the search of optimal application of the tourniquet and the~     related fluid management during 24 perioperative hours.~   "
168818|NCT01355887|"~     The purpose of this study is to better comprehend the benefits and efficacy of portal triad~     clamping with infrahepatic IVC clamping during complex hepatectomy. A randomized comparative~     trial was performed to compare PTC(pringle triad clamping) with either infrahepatic IVC~     clamping or low central venous pressure in complex liver resections.~   "
168819|NCT01355874|"~     Primary Objective:~      To evaluate the effect of iferanserin ointment on cessation of bleeding when administered~     intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal~     hemorrhoids.~      Methodology:~      Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group,~     placebo-controlled part of the study. Extension: Multicenter, open-label part of the study.~      Study Treatment Duration:~      Double-Blind: 28 days (14-day treatment period and a 14-day follow-up period). Extension: 12~     months (open-label part of the study in which there will be a scheduled visit every three~     months. Subjects who have recurrence(s) of their symptomatic internal hemorrhoids will be~     treated with open-label iferanserin for 7 days followed by a 21-day follow-up period).~      Criteria for Evaluation:~      Primary Endpoint:~      The primary endpoint is the cessation of bleeding by the end of Day 7 that persists for the~     remainder of the treatment period (through Day 14).~   "
168820|NCT01355861|"~     The purpose of this study is to determine the benefits of negative work progressive~     resistance exercise (PRE) for the conservative management of sarcopenia in older male~     Veterans at the DC VAMC. Efficacy will be assessed by examining post-exercise changes in~     metabolic and inflammatory markers, muscle morphology, strength, and functional status.~   "
168821|NCT01355848|"~     The aim of the study is to refine, elaborate, and pilot a brief intervention for adult~     patients following a suicide attempt provided during hospitalization in an acute medical~     setting. 40 participants will be randomized to receive the brief intervention + care as usual~     or only care as usual. It is hypothesized that the intervention will be acceptable and~     feasible to both patients and intervention clinicians.~   "
168822|NCT01355835|"~     12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best~     individual subthalamic nucleus stimulation and dopaminergic medication will be included into~     this randomised double-blind cross-over two-armed clinical trial. The treatment consists of~     two different stimulation settings using (i) conventional stimulation of the subthalamic~     nucleus [STNmono] and (ii) combined stimulation of distant electrode contacts located in the~     subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata~     [STN+SNr].~   "
168873|NCT01355146|"~     The purpose of this study is to proof increasing patient satisfaction and preservation of~     quality of life in patients with Morbus Fabry disease receiving their Enzyme Replacement~     Therapy with Replagal (Agalsidase alfa) at home compared to receiving the infusions at the~     clinic or at doctor's practice.~   "
168823|NCT01355822|"~     Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical~     underlying placental pathology revealing small placentas and maldevelopment of the decidual~     blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide~     (NO) donors can improve decreased uteroplacental perfusion without any negative effects on~     fetal circulation, these may prevent negative pregnancy outcomes in patients at risk.~      The aim of this study is to evaluate the effectiveness of the long-lasting NO donor~     pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes~     (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm~     delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid~     gestation.~   "
168824|NCT01355809|"~     The purpose of this study is to evaluate effects of inspired gas mixtures on the distance~     walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a~     Six-Minute Walk test.~   "
168825|NCT01355796|"~     Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and~     recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt~     concentration has been shown to increase activity of salt sensitive antimicrobial peptides.~      Xylitol is a 5-carbon sugar that can lower the ASL salt concentration, thus enhancing innate~     immunity.In this study, the investigators plan to study the safety and efficacy of 2 weeks of~     inhaled xylitol compared to 2 weeks of hypertonic saline in a randomized crossover design in~     stable subjects with cystic fibrosis~   "
168826|NCT01355783|"~     The purpose of this study is to evaluate whether treatment of E7777 in combination with CHOP~     has superior efficacy compared with CHOP alone in improving complete response rate (CRR) in~     first line treatment of subjects with Peripheral T-cell Lymphoma (PTCL).~   "
168827|NCT01355757|"~     Randomized controlled trial on efficacy of single injection or continuous interscalene~     brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.~   "
168828|NCT01355744|"~     About spider bites in Middle Europe, there are published only a dozen cases. The~     investigators suspect that they may be much more frequent than reflected by the literature~     analysis (but much less dangerous than thought by people). From June 1st 2011 to November~     30st 2012 the investigators collect clinical data on patients treated for spider bites in~     Switzerland.~   "
168829|NCT01355731|"~     Professional therapeutic boundaries are defined as the limits that protect the space between~     a professional's power and patient's vulnerability. It is important to develop therapeutic~     alliances while maintaining boundaries, thus ensuring nurses develop safe connections with~     patients and their families based on therapeutic needs. Due to the professional nature of~     nursing, boundary violations are common. For example, closeness and familiarity develops~     between the healthcare provider, patient, and caregiver that encompass the physical,~     emotional, and spiritual realms. This provides an opportunity for intense bonds with patients~     and families. Furthermore in oncology healthcare, providers deliver compassionate care and~     empathize with patients and families while sharing in the patient's illness journey. As a~     result of these bonds and relationships the nurse may over disclose personal information,~     provide excessive patient attention, meeting their own personal needs instead of the patient~     and family. In addition, continuity of care contributes to boundary crossings because there~     is frequent repeated contact with the same patients and families which allows blurring of~     boundary lines. When staff spend weeks, months, or even years with the same patient the~     opportunity to connect and talk about personal life details exist. At the national level, the~     National Council of State Boards of Nursing (NCSBN) has created materials for educating~     nurses in maintenance of therapeutic boundaries. Adherence to therapeutic boundaries has now~     become an education objective, with the development of educational interventions within many~     health care settings. Likewise, St. Jude nurses are at an increased risk of crossing~     therapeutic boundaries due to long term care relationships and vulnerable family members.~     However, nursing administration has not formally assessed the attributes or behaviors of the~     nursing staff. This proposal will describe the attributes and behaviors of the St. Jude staff~     nurse towards nurse-patient/family boundaries, providing knowledge to nursing leadership that~     will facilitate therapeutic boundaries focus groups with direct care nurses.~   "
168830|NCT01355718|"~     This trial is conducted in Asia. The primary objective of this study is to evaluate the~     clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue~     combination therapy in type 2 diabetes under normal clinical practice conditions in Korea~     while the secondary objective is to evaluate the safety and efficacy after 13 and 26 weeks of~     NovoNorm® and insulin analogue combination therapy in type 2 diabetes under normal clinical~     practice conditions in Korea.~   "
168831|NCT01355705|"~     To assess if amrubicin is safe and useful for patients with multiple myeloma requiring~     additional treatment.~   "
168832|NCT01355692|"~     The population of people suffering from diabetes is rapidly increasing, from an estimated 110~     million in 1994 to 221 million in 2010. Diabetic macular edema is the most common reason for~     reduction in visual acuity in diabetic patients.~      The standard care for diabetic macular edema is focal and /or grid retinal photocoagulation.~     During photocoagulation, small laser burns are applied to the retina, the sensory tissue that~     lines the back of the eye. Studies have shown that photocoagulation of clinically significant~     diabetic macular edema substantially reduces the risk of visual loss, increase the chance of~     visual improvement and decrease the frequency of persistent macular edema. However, it~     remains unknown whether the destruction of sensory layer of the retina during~     photocoagulation that may cause visual field defects is necessary for successful treatment or~     is just an unwanted and unnecessary side effect.~      Based on these concept, a photocoagulation technique was developed to treat the retina~     selectively (SRT - Selective retinal therapy), with minimal or no damage to the sensory~     layers. While the treatment is very similar to regular photocoagulation, the SRT laser uses~     much lower energy and very short pulses. As a result, treatment does not result in visible~     burns to the retina and previous studies have shown that the sensory layer remains intact.~      The aim of this study is to determine the effect of SRT on the resolution of the edema.~   "
168833|NCT01355679|"~     The purpose of this study is to test the feasibility (ability to be done) of an experimental~     test to help plan your cancer treatment. This study plan is not studying the effectiveness of~     the proposed combinations of therapy for your cancer that you may receive after the~     experimental testing.~      This study will look at an experimental technology to determine a tumor's molecular makeup~     (gene expression profile). This technology (called OncInsights) is being used to discover~     new ways to understand cancers and potentially predict the best treatments for patients with~     cancer in the future. The experimental technology has not been approved by the U.S. Food and~     Drug Administration.~   "
168834|NCT01355666|"~     The primary purpose of this research study is to evaluate if DermaTherapy® bedding will~     significantly reduce pressure ulcer incidence by decreasing maceration, friction, and~     shearing among residents of Nursing Homes.~   "
168835|NCT01355653|"~     This study is designed to compare the safety, as measured by skin findings and adverse~     events, of two different heat devices in elderly, overweight, and elderly and overweight~     subjects.~   "
168836|NCT01355640|"~     1. The purpose of this study is to research and compare two sucking modes'~          effect(breast-feeding and non-nutritive sucking) and difference,hypothesis is that these~          two kinds of methods can decrease pain for Chinese term infants receiving heel stick.~        2. A convenient sample of 90 neonates from a hospital in Beijing undergoing heel stick for~          Newborn Screening Program Blood Test were enrolled. They were randomized into three~          groups:~             -  breast-feeding group~             -  non-nutritive sucking group~             -  control group~        3. The results showed that:~             -  Breast-feeding can reduce crying and grimace time, increase oxygen saturation.~             -  Non-nutritive sucking can delay grimace's starting time, increase oxygen~               saturation.~   "
168837|NCT01355627|"~     The primary objective is to demonstrate superiority of TachoSil® compared to current practice~     as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be~     evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as~     an adjunct in sealing the dura mater.~      The trial population will consist of 726 randomised (1:1) patients elected for skull base~     surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1~     weeks and safety follow-up 28±2 weeks after surgery.~   "
168838|NCT01355614|"~     This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's~     disease.~   "
168839|NCT01355601|"~     This clinical trial will determine the effect of varying types of carbohydrates on children's~     concentration.~   "
168840|NCT01355588|"~     This was a phase 1, double-blind, 4-way crossover study in healthy male and female~     volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg.~     There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects~     were randomised to receive either a single intranasal dose of 30 mg ketorolac tromethamine~     alone or single intranasal dose of 30 mg ketorolac tromethamine with 4%, 5% or 6% lidocaine~     hydrochloride. At the end of the study each subject had received all 4 treatments.~      The primary objective of this study in healthy volunteers was to compare the safety,~     tolerability, and pharmacokinetics of 4 formulations of ketorolac tromethamine. A secondary~     objective was to monitor lidocaine hydrochloride plasma levels.~   "
168841|NCT01355575|"~     TITLE Rifaximin in Fatty Liver Disease (RiFL) DESIGN Proof-of-principle, open-label,~     randomised, cross-over, controlled study HYPOTHESIS Reduction in gut flora by the antibiotic~     Rifaximin reduces hepatic inflammation in Non-Alcoholic Steatohepatitis (NASH).~      AIMS To provide proof-of-concept data on the therapeutic potential of gut flora modification~     in NASH OUTCOME MEASURES~      Primary:~      • Change in serum ALT from baseline by 25 IU/L or to within normal range after 6 weeks of~     therapy~      Secondary:~        -  Change in intrahepatic triglyceride, estimated by in vivo proton magnetic resonance~          spectroscopy (1H MRS)~        -  Change in hepatic insulin resistance, estimated by the hyperinsulinaemic euglycaemic~          clamp~        -  Changes to the faecal bacterial microbiome assessed by faecal DNA pyrosequencing and~          fluorescent in-situ hybridisation (FISH)~        -  Differences in urinary metabolic profiles as assessed by high-resolution proton nuclear~          magnetic resonance spectroscopy~      POPULATION Patients with biopsy-confirmed non-alcoholic steatohepatitis and persistently~     raised serum aminotransferase levels~      TREATMENT The non-absorbable antibiotic Rifaximin DURATION Study duration 18 months.~     Individual patients' participation 18 weeks, with clinical follow-up 3 months after the end~     of the study.~   "
168842|NCT01355562|"~     The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.~   "
168843|NCT01355549|"~     Shoulder pain is common in persons with spinal cord injury (SCI). It is most often caused by~     overuse injuries to the muscles and tendons that can occur during wheelchair propulsion,~     transfers, and other activities of daily living. Normally, shoulder pain resolves with~     conservative treatments such non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen,~     naproxen, etc.) and physical therapy. However, when these treatments fail, shoulder surgery~     may be the only option.~      Platelet Rich Plasma therapy, or PRP, is a treatment option for non-healing muscle and tendon~     injuries such as those that cause shoulder pain in persons with SCI. Using one's own blood,~     cells within the blood called platelets are concentrated and then re-injected into the~     muscle and tendon of the shoulder. These platelets release substances known as growth~     factors that lead to tissue healing. By concentrating the platelets we increase the growth~     factors up to eight times which will promote the healing of tendons. PRP therapy has shown~     promise in treating tendon and muscle injuries in able-bodied persons; however, its~     effectiveness in persons with SCI is unknown. The purpose of this study is to explore the~     feasibility, safety, and efficacy of PRP therapy for chronic shoulder pain in persons with~     SCI. The human body has a remarkable ability to heal itself and we hypothesize that~     re-injecting concentrated platelets will facilitate the natural healing process and will~     reduce shoulder pain in persons with SCI.~   "
168844|NCT01355536|"~     The prevalence of preterm birth is rising in most western countries. The causes of preterm~     birth is not fully understood and seem to be multifactorial. The endocrine and metabolic~     aspects are scarcely investigated.The main purpose of this study is to test the hypothesis~     that endocrine and metabolic factors associate to preterm births.~   "
168845|NCT01355523|"~     The purpose of this study is to investigate the effect of 6 mg melatonin daily for 1 week~     preoperatively to 12 weeks postoperatively on depressive symptoms, anxiety, cognitive~     function and sleep disturbances in breast cancer patients. Furthermore the investigators will~     examine whether a specific clock-gene (HPER3) is correlated with an increased risk of~     depression, sleep disturbances or cognitive dysfunction.~   "
168874|NCT01355133|"~     The purpose of this pilot clinical study is to determine if intrasphincteric autologous~     myoblast injections in combination with electrical stimulation are safe and effective in~     treating stress urinary incontinence, confirming the optimal dose and assessing tolerability~     of the procedure.~   "
168913|NCT01354626|"~     The objective of this study is to investigate the potential beneficial effect of increasing~     protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.~      The investigators hypothesize that increasing protein in a high-fat diet suppresses lipid~     accumulation in the liver, and that changes in (hepatic) fat handling underlie this reduced~     lipid accumulation.~   "
172217|NCT01310985|"~     A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam~     Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized~     (Non-Metastatic) Rectal Cancer~   "
168846|NCT01355510|"~     Electrical stimulation of carotid baroreceptors (baropacing) acutely decreases arterial~     pressure in patients with refractory hypertension. The reduction in blood pressure seems to~     be mediated through sympathetic inhibition with concomitant reduction in the activity of the~     renin-angiotensin system. Indeed, switching on and off the stimulation is accompanied by~     decreases and increases in central sympathetic vasoconstrictor outflow, respectively. Plasma~     renin concentration also decreases with acute electrical baroreflex stimulation.~      In some patients chronic baropacing is associated with long-term blood pressure reduction.~      However, there is sparse information as to the relative contribution of blood pressure~     regulating systems to account for the acute and chronic effects of baropacing. Sympathetic,~     renal, and vascular mechanisms are of special interest. Furthermore, technical aspects of~     electrical baroreflex stimulation may play a role, e.g. worsening of the electrical contact~     between the stimulating electrodes and the baroreceptor afferents.~      This study is designed to answer the following primary questions:~        1. Does chronic electrical stimulation of carotid baroreceptors inhibit sympathetic~          vasoconstrictor tone also in the long-term?~        2. Does sympathetic vasoconstrictor tone increase on switching off chronic baropacing? Such~          an increase would confirm electrical integrity of the system and proper contact to the~          baroreceptor afferents.~        3. Does acute electrical baroreflex stimulation decrease renal vascular resistance?~        4. Does acute electrical baroreflex stimulation influence glucose delivery to skeletal~          muscle and change insulin sensitivity? The study follows an open-label observational~          design and it is planned to recruit up to 30 patients over 3 years.~   "
168847|NCT01355497|"~     The purpose of this study is to determine if the investigational drug GTx-024 can help~     patients with non small cell lung cancer increase physical function and maintain or gain~     muscle.~   "
168848|NCT01355484|"~     The purpose of this study is to determine if the investigational drug GTx-024 can help~     subjects with non-small cell lung cancer increase physical function and maintain or gain~     muscle, also called lean body mass.~   "
168849|NCT01355471|"~     This is a Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial~     erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied~     topically once daily is more efficacious than vehicle and provides an acceptable safety~     profile in the treatment of facial erythema associated with rosacea.~   "
168850|NCT01355458|"~     Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema~     associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once~     daily is more efficacious than vehicle and provides an acceptable safety profile in the~     treatment of facial erythema associated with rosacea.~   "
168851|NCT01355445|"~     This is an international open-label, randomized, multicenter phase II study of VIT and VI for~     the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will~     evaluate the safety and efficacy of these combinations in patients with recurrent or~     refractory rhabdomyosarcoma.~   "
168852|NCT01355432|"~     This is a prospective pilot study to quantify the changes in heart rate when propofol is~     administered after inhalational anesthesia induction.~   "
168853|NCT01355419|"~     In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor.~     The investigators can suppose that with continuous positive airway pressure (CPAP) therapy,~     there is an improvement in sleep quality, such that patients need less sleep to be fit. Sleep~     schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The~     investigators have planned to study sleep schemes before and after CPAP therapy in moderate~     to severe sleepy OSA patients.~   "
168854|NCT01355406|"~     This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to~     cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal~     artery. The arteries are often abbreviated as femoropopliteal.~      The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding~     Stent System is safe and effective for the treatment of patients with peripheral arterial~     disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy~     performance goals established for Femoropopliteal bare nitinol stents in patients with~     symptomatic peripheral arterial disease.~   "
168855|NCT01355393|"~     This randomized phase I/II trial studies the side effects and best dose of rintatolimod when~     given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in~     treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive~     breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an~     effective immune response to kill tumor cells that express HER-2/neu. Adjuvant therapies,~     such as GM-CSF and rintatolimod, are additional cancer treatments given after the primary~     treatment to lower the risk that the cancer will come back and are one way to help vaccines~     produce stronger immune responses. Giving vaccine therapy together with rintatolimod and/or~     GM-CSF may be a safe and effective treatment for breast cancer.~   "
168856|NCT01355380|"~     This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for~     treatment with Ventavis.~      Typical clinical measures and quality of life will be prospectively followed in 12 months~     period.~   "
168857|NCT01355367|"~     This is a clinical study evaluating the safety and efficacy of long term administration of~     oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for~     whom the test drug is tolerable during the 8 week double blind treatment phase of Study~     13176.~   "
168858|NCT01355354|"~     The purpose of this study is to investigate the drug interaction between fostamatinib and~     digoxin by comparing the safety, tolerability and plasma concentration of digoxin when~     administered alone and with fostamatinib in healthy subjects.~   "
168859|NCT01355341|"~     More specifically, the present invention relates to a 'Herbal Preparation' that is useful for~        -  Treatment of Renal calculi~        -  Reduction in the stone size & surface area~        -  The expulsion of stone~        -  Decreased need of Analgesic(Antiinflammatory Effect)~        -  Stops the recurrence and reformation of renal~   "
168860|NCT01355328|"~     In this study, the investigators will evaluate the potential of multiphoton microscopy as a~     non-invasive imaging modality for monitoring of the radiofrequency-tissue and light-tissue~     reaction. The investigators will also investigate drug delivery using multiphoton microscopy.~   "
172218|NCT01310972|"~     Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX~   "
168861|NCT01355315|"~     Enhanced external counterpulsation (EECP) is a noninvasive circulatory assist device that has~     been as a treatment option for refractory angina in left ventricular (LV) dysfunction.~     Recently, its potential role in heart failure management has been shown. However, although~     the concept of EECP was introduced almost four decades ago, and despite growing evidence~     supporting the clinical benefit and safety of this therapeutic modality, little is firmly~     established regarding the mechanisms responsible for the benefit of EECP include improvement~     in endothelial function, promotion of coronary collateralization, enhancement of ventricular~     function, and peripheral effects. Therefore, the major aim of this study is to provide an~     alternative treatment, EECP, for those unsuitable for standard procedures, especially for~     patients whose heart failure was caused by repeated myocardial infarction, called ischemic~     cardiomyopathy (ICMP), and to evaluate the clinical outcome and the endothelial function~     before and after 35 hours of EECP treatment.~   "
168862|NCT01355302|"~     The purpose of this study is to determine the following: 1. Find the maximum tolerated dose~     of E7050 when given in combination with cisplatin and capecitabine in patients with advance~     or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and~     capecitabine is more effective in patients with previously untreated gastric cancer versus~     cisplatin and capecitabine alone.~   "
168863|NCT01355289|"~     To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic~     hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment.~   "
168864|NCT01355276|"~     The purpose of this study is to compare Cinitapride tablets with domperidone tablets~     (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment~     of mild to moderate functional dyspepsia.~   "
168865|NCT01355263|"~     The investigators plan to perform a randomized, mutual-control and double-blinded cohort~     study to further exploit the vitamin A supplementation on iron metabolic homeostasis~     (including iron reserve, mobilization and absorption status in the same population) compared~     with solely iron and vitamin A plus iron.~   "
168866|NCT01355237|"~     This research study is being done to understand the outcomes of back pain treatment and costs~     associated with it in an academic hospital outpatient setting. The investigators will conduct~     a prospective observational cohort study to assess the clinical outcomes and utilization of~     health care services of 175 Osher Clinical Center (OCC) patients with chronic low back pain~     (CLBP) compared with a comparison group of 175 non-OCC CLBP patients treated within Brigham~     and Women's Hospital. Outcomes will include assessment of functional status, symptom relief,~     satisfaction with care, health-related quality of life, and worker productivity, and will be~     measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3,~     6, and 12 months.~   "
168867|NCT01355224|"~     This study will examine the impact of providing genetic risk information for obesity on~     people's attitudes and beliefs about obesity, health behaviors and weight outcomes.~     Specifically, this study will examine the feasibility of using genetic information to~     motivate efforts to reduce obesity among individuals recruited to the Coriell Personalized~     Medicine Collaborative (CPMC), see below for description of CPMC.~   "
168868|NCT01355211|"~     The aim of the proposed research is to compare the diagnostic accuracy of a portable wireless~     electroencephalography (EEG) device (Biosignal Micro-EEG) to standard EEG in identifying~     abnormal EEG patterns (mainly non-convulsive seizure and non-convulsive status epilepticus)~     in emergency department (ED) patients with altered mental status. Comparing the the accuracy~     of EEG recordings and interpretations of Micro-EEG to those of standard EEG will allow the~     investigators to assess the utility of this novel device in the ED patients with altered~     mental status. The unique qualities of Micro-EEG device could potentially facilitate easier~     access to EEG test in all ED patients.~      This study will also provide valid information regarding the prevalence of non-convulsive~     seizure in ED patients with altered mental status.The gold standard for diagnosing~     non-convulsive seizure would be standard EEG.~      All study participants will undergo electroencephalography using the two devices (standard~     EEG and micro-EEG) and a combination of standard electrodes and Electro-Cap in a randomized~     order: 1. Standard EEG with standard EEG electrodes, 2. Micro-EEG with standard EEG~     electrodes, and 3. Micro-EEG with Electro-Cap electrodes.~   "
168869|NCT01355198|"~     HIV infection is associated the development of increased oxidative stress and deficiency of~     glutathione (GSH), the dominant endogenous antioxidant protein, but the underlying mechanisms~     contributing to GSH deficiency are hitherto unknown. Furthermore GSH metabolism has not been~     studied in HIV patients, in whom the burden of risk factors promoting oxidative stress is~     highest. Our previous studies in non-HIV human subjects with diabetes-related oxidative~     stress and GSH deficiency have demonstrated that the latter is due to decreased synthesis of~     GSH. Importantly, short-term dietary supplementation with the simple GSH precursor~     amino-acids cysteine and glycine, boosted GSH synthesis and cellular concentrations,~     corrected GSH deficiency, and reduced oxidative stress and oxidant damage. The current~     proposal will study whether (1) defective synthesis underlies GSH deficiency in patients with~     HIV, and will test a simple, inexpensive and rational therapy based on protein~     supplementation to improve GSH synthesis and concentrations and lower markers of oxidative~     stress and oxidant damage in these patients; (2) study if correction of GSH deficiency is~     asssociated with any changes in (a) impaired mitochondrial fuel oxidation in the fasted and~     insulin stimulated states; (b) insulin sensitivity; (c) body composition and anthropometry;~     (d) forearm muscle strength; (e) plasma biochemistry, and (f) quality of life indices in~     these subjects.~   "
168870|NCT01355185|"~     There are substantial uncertainties with contemporary seed placement techniques in prostate~     brachytherapy, particularly with the impact of seed movement after an implant due to edema~     and migration of seeds in the prostate and peri-prostatic tissues. This study will accrue 20~     patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at~     specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these~     phenomena.~   "
168871|NCT01355172|"~     The purpose of this study is to evaluate the antibody response to each of the three influenza~     vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by~     hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart,~     in infants between 6 and 12 months of age.~   "
168885|NCT01354990|"~     The primary objective of this study is to obtain safety information on the use of sitagliptin~     (JANUVIA®) from endocrinologists, diabetologists, internists, and general practitioners.~   "
168875|NCT01355120|"~     This is an open-label, multi-center, single-arm clinical phase II study to further~     characterize the efficacy and safety of ipilimumab in patients with or without systemic~     pretreatment metastatic ocular melanoma.~      The DeCOG-MM-PAL11-Trial will be continued only for patients with ocular melanoma because~     sufficient numbers of cutaneous and mucosal melanoma patients have already been recruited. In~     order to allow the separate subgroup analysis as planned in the protocol for ocular melanoma~     it is mandatory to focus the recruitment to this patient population. Only this will guarantee~     a valid evaluation of all cohorts. Ocular melanoma is defined as melanomas originated from~     uvea, the choroid, the ciliary body and conjunctiva. (see McCartney ACE Pathology of ocular~     melanomas British Medical Bulltta, 1995, Vol 51, No 3 pp 678-693) The same criteria and~     treatment procedure as those used before will be applied for the patients with advanced~     ocular melanoma. Since no treatment standard in those patients does exist, also patients~     without prior systemic treatment can be included in this study. Therefore, the 5th inclusion~     criterion has been adapted in order to enrol the eligible patients.~   "
168876|NCT01355107|"~     The incidence of hepatocellular carcinoma (HCC) is rising worldwide.One important etiology is~     a chronic inflammation due to hepatitis c (hcv) infection. Over the steps of a chronic~     inflammation over the stadium of cirrhosis of the liver it is possible that neoplastic~     nodules appear in the liver which can rise up to a HCC. In the pathogenesis of HCC oxidative~     stress seems to play an important role and as selenium is a key micronutrient in this process~     its levels could differ between the different stages of disease in hcv- infected patients.~     The aim of this trial is to examine these differences.~   "
168877|NCT01355094|"~     This pilot study will evaluate the effectiveness in actively removing the peritoneal fluid~     through the use of a commercial suction device compared to passive drainage of the same~     peritoneal fluid drained through standard surgical drains under bulb suction only, in~     critically ill patients who require an open abdomen. Both techniques being used, the~     commercial KCI AbThera™ device and home made Stampede VAC system, are currently approved~     for use in Canada and used in our facility.~      The use or non-use of the open abdomen and its relationship to intra-abdominal hypertension~     (IAH) and the abdominal compartment syndrome (ACS), the level of IAH must be treated and if~     so how should be treated - remain controversial. The ultimate treatment for IAH/ACS is to~     leave the abdominal fascia open after laparotomy, utilizing some form of temporary abdominal~     closure (TAC) techniques, resulting in an open abdomen(OA). The decision to accept an OA~     can only be made in the operating room and is typically made quite arbitrarily (there is no~     current standard or protocol),and the TAC used is based on the surgeon's best judgment. The~     study intends to randomize patients after it has been decided that a TAC is required, which~     will be applied in the operating room while the patient is fully anesthetized. The only~     intervention required is to obtain small aliquots (a teaspoonful-15ml) of blood for the~     evaluation of inflammatory mediators levels, as well as the same volume of intra-peritoneal~     fluid-that is typically discarded in patients with OA.~   "
168878|NCT01355081|"~     The purpose of this study is to assess the efficacy, safety and tolerability of 8-week~     treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with~     major depressive disorder.~      The purpose of this study is to assess the efficacy, safety and tolerability of 8-week~     treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive~     disorder.~   "
168879|NCT01355068|"~     In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and~     Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a~     pivotal bioequivalence study.~   "
168880|NCT01355055|"~     Primary hypothesis:~      Catheter-based renal denervation reduces central sympathetic activation in patients with~     refractory hypertension.~      Secondary hypotheses:~        1. The magnitude of the individual depressor response after catheter-based renal~          denervation depends on the extent of sympathoinhibition.~        2. Both, the reduction in arterial pressure and in central sympathetic activation are~          sustained over time up to 24±3 months after catheter-based renal denervation.~        3. Catheter-based renal denervation resets the sympathetic baroreflex to lower blood~          pressure values.~   "
168881|NCT01355042|"~     Severe sepsis (ie. life-threatening infections) is triggered by harmful microorganisms or~     their toxins in the blood or tissues. These harmful agents damage the lining of blood vessels~     which can lead to inflammation, blood clot formation, and vessel obstruction. In Canada,~     there are approximately 90,000 patients with severe sepsis each year. Of these, 30% to 50%~     will die. The identification of highly reliable outcome predictors in severe sepsis patients~     is important for several reasons including: to help describe the severity of sepsis, to~     classify patients for enrollment in clinical studies, and to monitor a patient's response to~     treatment and procedures. In the investigators lab, the investigators examined the~     incremental usefulness of adding multiple biomarkers to clinical scoring systems for~     predicting ICU mortality in patients with severe sepsis. In a preliminary study of 80~     patients with sepsis, the investigators found that high levels of plasma DNA predicted ICU~     death better than any other clinical or biological factor. In this grant, the investigators~     propose to confirm these findings in an external group of 400 patients in a blinded fashion.~     The investigators also plan to study how plasma DNA levels change over time and whether high~     plasma DNA levels can be used to distinguish sepsis from other critically ill conditions. For~     this the investigators will compare the investigators septic patients to a cohort of 600~     patients in the ICU with other conditions. The investigators believe this research has the~     potential to significantly improve the management and treatment of septic patients.~   "
168882|NCT01355029|"~     The study will be evaluating to a 4 week education and support program for stroke caregivers.~     The 4 week program will provide education, information, and strategies for dealing with areas~     that caregivers may find challenging in their caregiving role. The study will evaluate the~     effectiveness of the program to decrease the caregiver's stress, strain and burden, increase~     the caregiver's knowledge of strategies and community services and increase their role~     satisfaction as a stroke caregiver and quality of life two weeks after the program and 6~     months after the program.~   "
168883|NCT01355016|"~     The purpose of this study is to determine the range of single inhaled doses of a new dry~     powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects~     on pulmonary function and determination of blood levels of MDT-637 following inhalation.~   "
168884|NCT01355003|"~     This study will collect safety information on the use of GARDASIL™ in the Philippines.~   "
168886|NCT01354977|"~     Human aging is associated with increased fat mass, insulin resistance and systemic~     inflammation. In addition to overall increases in fat mass, accumulation of lipid in such~     insulin-sensitive tissues as liver and skeletal muscle appears to contribute importantly to~     insulin resistance. Furthermore, age-related decreases in muscle mitochondrial ATP production~     rate and mitochondrial DNA copy number are likely to contribute to impaired insulin-mediated~     glucose disposal, as well as decreased muscular endurance and activity levels. Additionally,~     systemic inflammation is now believed to contribute to insulin resistance and thus ultimately~     to many age-related disorders, including diabetes mellitus, Alzheimer's disease,~     atherosclerosis and many cancers.~   "
168887|NCT01354964|"~     The purpose of this research is to study the effects of Vitamin D supplementation on the~     body's response to insulin (a hormone that controls blood sugar), on inflammation and/or on~     specific cells and processes in fat tissue, and on function of skeletal muscle and joints.~   "
168888|NCT01354951|"~     The purpose of this study is to see what side effects a type of radiation treatment called~     focal brachytherapy has in treating early stage prostate cancer. The study is also looking at~     how useful focal brachytherapy will be in treating prostate cancer. Additionally, the~     investigators would like to see how this type of treatment impacts quality of life.~   "
168889|NCT01354938|"~     The objective of this study was to evaluate the role of Klaricid XL (clarithromycin modified~     release) in the treatment of acute exacerbation of chronic bronchitis (AECB) and its impact~     on improving the quality of life.~   "
168890|NCT01354925|"~     Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for~     all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can~     induce harmful effects and complications in patients with diabetes. Several studies have~     demonstrated that patients with type 2 diabetes are prone to hypo and hyper glycemia during~     fasting. When treating diabetic patients with a treatment guideline the rate of these~     complications can be reduced. Little data is available on patients with type 2 diabetes~     treated with insulin. The investigators therefore propose to assess the effect of a protocol~     containing detemir (levemir) and a premix of insulin aspart (NovoMix70) on glucose control in~     patients with type 2 diabetes during the Ramadan and to compare this regimen to the standard~     care patients receive during this period. The investigators assume that patients receiving~     the intervention will have better glucose control during the Ramadan compared to patients~     receiving the standard care. As approximately 45 million Muslims suffer from type 2 diabetes~     and most of them fast during the Ramadan the results of this intervention may be significant~     and may improve the care of these patients allowing Muslims to respect their religious~     obligations without compromising their health.~   "
168891|NCT01354912|"~     Nontuberculous mycobacteria (NTM) are ubiquitous organisms in the environment and are now~     increasingly being recognized as significant causes of chronic pulmonary infection in~     immunocompetent individuals (1). The most frequently encountered NTM lung disease worldwide~     is caused by Mycobacterium avium-intracellular complex (MAC) (2-4).~      In several studies with chest computed tomography (CT), researchers have demonstrated that~     the presence of bilateral multifocal bronchiolitis (well-defined small nodules and branching~     centrilobular nodules, or tree-in-bud pattern) and bronchiectasis distributed mainly in the~     right middle lobe and lingular segment are indicative of NTM pulmonary infection (7-11).~     Accordingly, it is believed that radiologic findings of bilateral bronchiolitis and~     bronchiectasis on chest CT scans specifically suggest NTM pulmonary infection (1). These CT~     findings, however, may not be specific for NTM pulmonary infection. CT patterns of~     bronchiectasis and bronchiolitis in the pulmonary infections caused by various NTM organisms~     have been reported, and these organisms include Mycobacterium kansasii, Mycobacterium xenopi,~     and rapidly growing mycobacteria such as Mycobacterium abscessus, Mycobacterium fortuitum,~     and Mycobacterium chelonae (12-14). In addition, not all patients with bronchiectasis and~     bronchiolitis have NTM pulmonary infection. Two recent studies showed that only about 50% of~     patients with such CT features have MAC pulmonary infection (9,15). To the best of our~     knowledge, however, there is no report about the incidence of NTM in patients with~     bronchiectasis or bronchiolitis in countries with low incidence of TB. Thus, the purpose of~     our study was to determine the frequency of NTM pulmonary infection in patients with~     bilateral bronchiectasis and bronchiolitis at chest CT and to investigate whether these CT~     findings are specifically indicative of MAC infection or other specific pathogen.~   "
168892|NCT01354899|"~     The rational for the study is to add a thin self-adherent dressing on critically ill~     patients. Evaluate if the dressing might protect the skin for further breakdown.Participants~     will be followed for the duration of hospital stay, an expected average of 5 days.~   "
168893|NCT01354886|"~     The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a~     single dose administration of four doses of FSH-GEX™ in healthy pituitary-suppressed female~     volunteers, in comparison with two marketed comparator products.~   "
168894|NCT01354873|"~     The investigators seek to compare the accuracy of the existing colonoscope model to determine~     the magnitude of the improvement the investigators can expect in polyp discrimination as~     neoplastic or non-neoplastic.~   "
168895|NCT01354860|"~     This study aims to assess the feasibility, effectiveness and safety of moxibustion for~     symptom management and function improvement in patients with knee osteoarthritis, compared to~     usual care group.~   "
168896|NCT01354847|"~     This study is planned to investigate the relationship between duration of extracorporeal~     circulation and the extent of (acquired) platelet dysfunctions in patients undergoing cardiac~     surgery.~   "
168897|NCT01354834|"~     The purpose of this study is to assess the effectiveness of Menopur to achieve clinical~     pregnancy in females undergoing intrauterine insemination in clinical practice.~   "
168898|NCT01354821|"~     The aim of this study is to prospectively compare the perioperative mortality severe~     morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and~     3 thoracal abdominal aortic aneurysms.~   "
168899|NCT01354808|"~     The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance~     to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major~     adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients~     with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary~     intervention (PCI).~   "
168912|NCT01354639|"~     The robotic thyroidectomy (RT) has excellent cosmetic and several functional results. But~     there were no definite evidence of oncological safety of robotic thyroidectomy yet. To assure~     the surgical completeness of robotic thyroidectomy, the investigators compared robotic~     thyroidectomy and conventional open thyroidectomy (OT) by means of the postoperative~     radioactive iodine (RAI) uptake of possible remnant thyroid tissue and stimulated TG level.~   "
168924|NCT01354483|"~     The purpose of this study is to investigate the feasibility, safety, efficacy and optimal~     dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal~     cord injuries.~   "
168900|NCT01354795|"~     EUS-guided FNA has been proved to be a safe and useful method for tissue sampling of~     gastrointestinal track lesions and other organ lesions including mediastinal and~     intra-abdominal lymph nodes, pancreas and hepatobiliary tree. The usefulness of EUS-FNA~     depends on several factors. For example, experience of the endosonographers, adequate~     sampling, sample preparing, accurate interpretation by the cytopathologist and on-site~     cytopathology interpretation. However, in many hospitals, no cytopathologist can be present~     during EUS-FNA. Therefore, determining appropriate methods to obtain and prepare EUS-guided~     FNA are important to make correct a diagnosis without on-site cytopathologist.~      Suction with a self-retracting 10-mL syringe will likely bring in more cellularity but also~     more blood. Some endosonographers use no suction, others use constant suction. Usually~     specimen is expelled from a needle with pushing the stylet into the needle. But use of the~     stylet during EUS-FNA is difficult and time consuming process. Injecting air was not~     recommended, because of spraying out uncontrollably, increasing risk of air artifact and~     specimen clotting. However, there is no further study which one is the appropriate, suction~     or no suction and pushing the stylet or injecting air until now.~      The hypothesis and aim of the prospective randomized controlled trials are as follows:~      First hypothesis: There was no difference in the adequacy, cellularity, bloodiness,~     contamination, air artifact in specimen obtained by each methods, suction or no suction and~     pushing the stylet or injecting air.~      Aim #1 : To compare the adequacy, cellularity, bloodiness, contamination, air artifact in~     specimen obtained by each methods, suction or no suction and pushing the stylet or injecting~     air.~      Second hypothesis: There was no difference in sensitivity, specificity, diagnostic accuracy,~     positive predictive value, negative predictive value and statistical agreement in specimen~     obtained by each methods, suction or no suction and pushing the stylet or injecting air.~      Aim #2 : To compare the sensitivity, specificity, diagnostic accuracy, positive predictive~     value, negative predictive value and statistical agreement in specimen obtained by each~     methods, suction or no suction and pushing the stylet or injecting air.~   "
168901|NCT01354782|"~     The primary objective is to assess the pharmacokinetics (PK) of roflumilast and its~     metabolite roflumilast N-oxide after single and repeated oral administrations of roflumilast~     500 μg in healthy Chinese subjects.~   "
168902|NCT01354769|"~     Capgnography is the monitoring of the concentration or partial pressure of carbon dioxide in~     the expired respiratory gases; as such, it is a non-invasive monitoring technique which~     allows fast and reliable insight into ventilation, circulation and metabolism. Capnography~     has proven to be more effective than clinical judgement alone in the early detection of~     adverse respiratory events. The shape of a capnogram is identical in all humans with healthy~     lungs; any deviations in shape must be investigated to determine a physiological or a~     pathological cause of the abnormality.~      Data from a previous pilot study yielded two major findings:~        1. Prediction of requirement for intubation, by the creation of an Integrated Pulmonary~          Index (IPI) based on non-invasive physiological parameters~        2. Breathing patterns during weaning in order to identify specific patterns used to predict~          extubation success/failure~      The intent of the current study is to gather sufficient data to either prove or disprove the~     findings of the previous study~   "
168903|NCT01354756|"~     Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric~     surgery. There is a need for alternative screening tools for sleep apnea detection in the~     pre-operative period. The investigators would like to compare ApneaLink and complete~     polysomnography in this population.~   "
168904|NCT01354743|"~     The purpose of this study is to provide data to support combination treatment of the upper~     face with Perlane-L® and Dysport™. This study will assess the outcome of upper face~     rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also~     be assessed as a secondary endpoint.~   "
168905|NCT01354730|"~     This was a retrospective cohort study of pregnant women who had received the AdimFlu-S~     (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed~     by chart review. If subject meets the eligibility criteria during the study period, data from~     the medical chart were extracted retrospectively from the date of vaccination and the infant~     (s) health status were followed until 8 weeks after the delivery.The unexposed cohort~     included pregnant women who did not receive any influenza vaccine during pregnancy. Within~     each participated study center, women who were gestation after April 2009 were randomly~     selected according to maternal age matching. The pregnancy outcome, including the status of~     delivery, abortion and gestational age, were extracted retrospectively by chart review.~   "
168906|NCT01354717|"~     This is a double-blind, randomized, placebo-controlled, three treatment parallel study in~     which normal, healthy men and women (age 45-85) with actinic keratosis will be treated on the~     face once daily for two weeks with 5-Fluorouracil Cream 0.5%, Spear Pharmaceuticals~     (Generic), Carac® Cream 0.5% (Brand), or Cream Vehicle (Placebo). Actinic keratoses will be~     counted at the baseline visit and at the visit four weeks following cessation of treatment.~   "
168907|NCT01354704|"~     The objectives of the study are:~      o Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing~     ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA~      o Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these~     patients compared with the original drug Lovenox ®.~   "
168908|NCT01354691|"~     For many, Alzheimer's disease is the number one medical issue facing our aging society. It is~     a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and~     cognitive performance. There are no known treatments that can either prevent or reverse its~     progression. Consequently, there still remains a need to evaluate treatments which can better~     stabilize the symptoms of this disease. These symptoms frequently include decreased~     functional capacity and negative psychological attributes (e,g, depression, anxiety) in~     association with the memory and cognition deficits. This current study is being done to~     assess an investigational compound that has been designed to not only improved the cognitive~     status of affected patients but to also better manage all symptoms. Hence, the ultimate goal~     is to provide patients with an improved quality of life by slowing the progression of this~     neurodegenerative disease~   "
168909|NCT01354678|"~     Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells~     transplantation by intramyocardial multiple precision injection in ischemic heart failure~     patients.~   "
168910|NCT01354665|"~     This study aims to evaluate the occurence and severity of fatigue and depression in multiple~     sclerosis patients and the impact of Betaferon treatment on symptoms alterations.~      The study is conducted in routine practice setting hence no interference with standard care~     takes place.~      Pharmacologic treatments of MS-fatigue and depression will also be recorded.~   "
168911|NCT01354652|"~     The purpose of this study is to investigate whether entecavir treatment increases the~     incidence of lactic acidosis compared to another nucleoside/nucleotide reverse transcriptase~     inhibitors (NRTI), lamivudine, and/or no NRTI treatment, in patients with cirrhosis or~     hepatic failure whose Model for End stage Liver Disease (MELD) scores are over 18.~   "
168953|NCT01354106|"~     The objective of this study is to determine the relative gentleness of two tapes recognized~     for gentleness. A three-prong multidimensional evaluation consisting of laboratory~     assessments, expert skin grader and subject discomfort assessment will be used.~   "
168914|NCT01354613|"~     Heart failure with preserved ejection fraction (HFpEF) accounts for over 50% of heart failure~     cases in the United States, affecting a primarily elderly population. No treatment has been~     shown to affect mortality in HFpEF, which is more than 50% at five years a hospitalization.~     This project explores the underlying cardiovascular physiology of patients with HFpEF with~     the goal of identifying new therapeutic targets that would allow improved treatment of this~     devastating disease.~   "
168915|NCT01354600|"~     The purpose of this research study is to examine the effects of overfeeding and exercise on~     blood levels of hormones associated with regulating appetite, also thought of as feelings of~     hunger and satiety (fullness). Previous studies have shown that non-obese people have~     different amounts of these hormones in their blood compared to obese people.~      The investigators hypothesize that exercise will promote improved insulin sensitivity and~     corresponding beneficial changes in obese individuals. The investigators predict exercise~     induced changes in 24-hour plasma hormone levels will be associated with improved appetite~     during overfeeding in obese individuals.~   "
168916|NCT01354587|"~     The purpose of this study is to measure the changes in the Treatment Satisfaction~     Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of~     administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects~     transitioning from subcutaneous Vivaglobin® to Hizentra®.~   "
168917|NCT01354574|"~     The purpose of this study is to determine if consumption of meals containing carbohydrates~     with different glycemic index (a high glycemic index meal and a low glycemic index meal)have~     different effects on energy expenditure, type of metabolic fuels used for energy, blood~     lipids and lipoproteins, and sensations of hunger, fullness, and the hormones related to~     satiety.~   "
168918|NCT01354561|"~     The present study investigated the influence of respiratory affections on the heart rate~     variability (HRV) of paediatric patients. We have hypothesised that respiratory physiotherapy~     would promote a beneficial effect on the cardiac autonomic modulation. Twenty-four children,~     who were divided into respiratory disease group (RG) and control (CG) groups, were studied.~     Analysis of HRV was performed with the RG in the dorsal decubitus position during four~     different moments: basal record (30 minutes); 5 minutes after respiratory physiotherapy by~     means of airway clearance techniques (10-minute record); 5 minutes after nasotracheal suction~     (10-minute record); and 40 minutes after nasotracheal suction (30-minute record). CG group~     was submitted to the same protocol, except nasotracheal suction, which was not performed due~     to ethical reasons.~   "
168919|NCT01354548|"~     Trismus (limited jaw mobility), can occur in patients undergoing radiotherapy to specific~     areas of the head or neck. Trismus leads to difficulty in eating, swallowing, speech and~     general mouth hygiene, which all have negative effects on quality of life. Research in the~     area of trismus is limited; it is not known exactly when trismus develops, one study suggests~     that some patients have experienced a diminished opening at as low doses as 15 Gy. Literature~     suggests benefits of a training programme, but there is a lack of evidence to support the use~     of a training programme during radiotherapy.~      The purpose of this study is to investigate the effectiveness of a training programme during~     and after radiotherapy, and report the incidence of trismus in patients who receive~     radiotherapy to the jaw muscles. The study also investigates quality of life during~     radiotherapy and up to one year after completed treatment.~      Patients who meet the criteria and give their consensus to the study are divided into two~     groups:~      Group 1: Training with TheraBite Jaw Motion Rehabilitation System, which is a portable system~     utilizing repetitive passive motion and stretching to restore mobility and flexibility of the~     jaw musculature. Individuals train five times a day.~      Group 2: Conventional treatment (jaw measurements once a week). If the individuals jaw~     mobility decreases 15% from the original start measurement, the patient is automatically~     offered a trainings program (as in group 1).~      During radiation therapy a hospital specialist dentist measures the jaw mobility once a week,~     thereafter at 3,6,12 months after completed Radiation Therapy. On 5 different occasions the~     patients are requested to complete a Quality of life questionnaire. Patient's record their~     training frequency in a log book.~   "
168920|NCT01354535|"~     The purpose of this study is to compare two different but standard treatments for the~     fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction~     internal fixation using a locked plating system versus plating and strut allograft with~     cerclage wiring to determine which treatment results in a faster return to function as~     measured by the TUG test at 6 weeks post-op.~   "
168921|NCT01354522|"~     Some sub-analysis has shown anthracycline-based regimens are not effective in Her-2 negative~     breast cancer, while capecitabine is more effective in this group of patients.~      This is a prospective, randomised phase III trial, to compare the efficacy and safety~     profiles of two types of adjuvant chemotherapy regimens for HER2 negative, node positive~     breast cancer patients.~      Control Arm: This includes 6 cycles of TAC 75/50/500 mg/m2 day 1 every 3 weeks. Experimental~     Arm: This includes 6 cycles of TC 75/500 mg/m2, day 1 every 3 weeks, concurrently with~     capecitabine 950 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest~     period.~      Women with hormone receptor positive tumours must receive 5 years endocrine after the end of~     chemotherapy.~      Patients may receive radiotherapy when clinically indicated.~   "
168922|NCT01354509|"~     Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets)~        1. Normothermia Protocol is successful in achieving and maintaining normal temperature in~          moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs~          from admission to Neuro ICU)~        2. Normothermia is translated into improved neurologic Outcome and survival compared to~          standard of care (Physician management)~   "
168923|NCT01354496|"~     The purposes of this study are to compare how much of LY2409021 enters the bloodstream and~     how long the body takes to get rid of the drug when different formulations of LY2409021 are~     given, and when LY2409021 is taken with or without food.~      The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of~     3 formulations of LY2409021. Subjects in each cohort will receive the same all 3 formulations~     using a randomized sequence crossover design. There is a washout period of at least 14 days~     between dosing periods.~      There will be an interim analysis after Cohort 1 completes study period 2. Cohort 2 will not~     begin enrolling until this analysis is complete. The need to enroll cohort 2 will be~     determined by the outcome of the interim analysis.~   "
168925|NCT01354470|"~     The proposed study will establish the safety and efficacy of modafinil in the treatment of~     methamphetamine dependence, as well as assess the affects of modafinil on cognitive function~     in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient~     trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or~     placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions.~     This study will be conducted at the Addiction & Pharmacology Laboratory in San Francisco, CA,~     and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.~   "
168926|NCT01354457|"~     The purpose of this study is to determine whether fractionated RIT with Epratuzumab and~     radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.~   "
168927|NCT01354444|"~     This is a 6-month pilot randomized double-blind placebo-controlled trial of carvedilol, with~     the primary objective being to determine whether carvedilol treatment is associated with~     improvement in Alzheimer's Disease (AD) as compared to placebo treatment. Secondary~     objectives are to monitor changes in cerebrospinal fluid amyloid levels and whether this dose~     will be safe and well-tolerated in AD patients. Clinical assessments will be performed at~     baseline, 3 months, and 6 months, while cerebrospinal fluid and blood samples will be~     obtained at baseline and 6 months.~   "
168928|NCT01354431|"~     The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal~     Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response~     relationship exists.~   "
168929|NCT01354418|"~     This study will assess the food-effect bioavailability of an extended release formulation of~     phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl~     product.~   "
168930|NCT01354405|"~     The aim of this study is to determine the effect of Lanreotide on polycystic liver and~     kidneys in patients with autosomal dominant polycystic kidney disease.~   "
168931|NCT01354392|"~     Diffuse large B-cell lymphoma is the commonest type of aggressive non-Hodgkin's lymphoma, a~     type of cancer of a cell called a lymphocyte which makes up part of the immune system.~     Although most patients are cured with chemotherapy used as initial treatment, about 20-30% of~     patients still experience relapse. Curing relapsed disease is much less successful, even with~     the use of high doses of chemotherapy and stem cell transplant. There is then an urgent need~     for effective, new agents to treat patients with diffuse large B-cell lymphoma who have~     relapsed or who have developed resistance to other forms of chemotherapy.~      This trial is using a drug called AZD1152 which interferes with the ability of a cancer cell~     to divide and grow. It has been used before in patients with other types of cancer, but never~     before in lymphoma patients. Responses in other cancers have been seen, particularly in~     leukaemia which is a disease related to lymphoma. The investigators are planning to use this~     agent in 15 patients with diffuse large B-cell lymphoma in which potentially curative~     treatments have failed. The main aim is to see whether the drug shows any activity in this~     type of lymphoma. This will be mainly assessed using CT and PET scans. The investigators are~     also investigating how well a blood test can predict both the response to the drug and the~     toxicity of the drug - this is called a biomarker study and forms part of the clinical trial.~     The other main aim of the study is to assess the toxicity of the treatment. Previous studies~     in humans suggest the drug is reasonably well tolerated, although side effects such as~     stomatitis (soreness of the mouth) and suppression of the bone marrow (leading to risk of~     infection and bleeding) have been seen.~   "
168932|NCT01354379|"~     The purpose of this study is to test the safety and immune response of a new intranasal~     vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that~     is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a~     vaccine work better), called W805EC. In a prior clinical study this vaccine showed promising~     results in terms of being well tolerated and eliciting mucosal and systemic immune responses~     after administration by a dropper. In this study NB-1008 is being administered by dropper as~     well as a nasal sprayer to determine if the sprayer further enhances the immune response.~   "
168933|NCT01354366|"~     This clinical trial will evaluate two investigational hypoallergenic infant formulas with a~     differing protein content to determine if they provide normal growth and are well tolerated~     by term infants as compared to a marketed hypoallergenic formula.~   "
168934|NCT01354353|"~     This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and~     tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated~     therapeutic exposure under clinical investigation. In the event of poor tolerability in part~     A of this study part B may be conducted to explore higher doses using titration. Subjects in~     both parts A and B will participate in a 9 day wash-out period of current medication (Study~     days 1-9); subjects coming into the study on aripiprazole will remain on their current~     therapy throughout.~   "
168935|NCT01354340|"~     The principal objective of this study is to investigate the dose-effect of the Limicol food~     supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.~   "
168936|NCT01354327|"~     The principal objective of this study is to investigate the effects of a novel food~     supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate~     hypercholesterolemia.~   "
168937|NCT01354314|"~     The purpose of this study is to see if paroxetine and fluconazole are safe and effective as a~     treatment for problems with memory, concentration, thinking, and judgment in people who are~     infected with HIV. Paroxetine is an antidepressant approved by the FDA to treat major~     depression. Fluconazole is an antifungal medication approved by the FDA to treat fungal~     infections.~   "
168951|NCT01354132|"~     The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early~     phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and~     Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur~     during the pre-illness phase and around the transition to psychosis. Therefore, studying new~     treatments that could target changes occurring during this period is of critical importance.~      Aims:~      Does add-on NAC treatment in early psychosis influence:~        -  positive and negative symptoms~        -  extrapyramidal side-effects of other medication~        -  plasma concentration of glutathione~        -  Mismatch Negativity, a physiological marker~   "
172219|NCT01310959|"~     Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome~   "
172220|NCT01310946|"~     Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology~   "
168938|NCT01354301|"~     Despite the improvement of efficacy results with current immunosuppressive regimens (about~     15% of incidence of acute rejection), the security schemes used do not show the same~     results.The most worldwide used regime is tacrolimus, mycophenolate and prednisone. Despite~     the favorable efficacy results in our population, the use of this combination is associated~     with higher incidence of viral infections such as cytomegalovirus, and gastrointestinal~     events, two common causes of hospital readmissions after renal transplantation at our~     institution.Given this, the investigators propose a study of our own initiative that attends~     our local needs: identify the best strategy among the therapeutic options available to~     maintain the result of current effectiveness and improve the safety profile for kidney~     transplant recipients.This protocol is a prospective, randomized, single center, designed to~     compare the safety and efficacy of three immunosuppressive regimens: (1) single dose of~     antithymocyte globulin, reduced exposure to tacrolimus, everolimus starting on day 2 after~     transplantation and prednisone; ( 2) basiliximab, reduced exposure to tacrolimus, everolimus~     starting on day 2 after transplantation and prednisone; (3-control group) basiliximab,~     reduced exposure to tacrolimus, mycophenolate and prednisone.Our hypothesis is that a single~     dose of antithymocyte globulin or basiliximab induction therapy in combination with low doses~     of tacrolimus, everolimus and prednisone results in comparable efficacy observed in patients~     receiving tacrolimus / mycophenolate / prednisone, but with a better safety profile.~      To ensure efficacy, the investigators added to the regimes the induction with monoclonal or~     polyclonal antibody. To improve the toxicities associated with the current scheme, the~     investigators replace the use of mycophenolate by everolimus and the investigators reduced~     the dose of tacrolimus.~      Patients will be monitored for blood levels of tacrolimus and everolimus to ensure adequate~     exposure to immunosuppressive agents.~   "
168939|NCT01354288|"~     DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific~     educational tool in order to assess its impact on glycemic control, quality of life,~     knowledge about the disease and its daily management, over a period of 2 years. The~     investigators plan to include 300 type 1 diabetic children in 10 french hospitals.~   "
168940|NCT01354275|"~     Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone~     (GnRH) agonist and GnRH Antagonist fixed protocol.~   "
168941|NCT01354262|"~     This is a prospective, randomized, non-blinded interventional study that will investigate the~     effect of a vitamin D supplement on HbA1c in patients with uncontrolled type 2 diabetes~     mellitus (DM) and vitamin D deficiency. The goal is to investigate whether correcting vitamin~     D deficiency will alter the HbA1c level in patients with type 2 DM and lower than normal~     vitamin D level. My hypothesis is that correcting vitamin D deficiency decreases HbA1c levels~     in patients with type 2 DM and vitamin D deficiency.~   "
168942|NCT01354249|"~     Prolonged fasting may increase the organic response to trauma. Carbohydrate-based drinks have~     been tested and they may reduce insulin resistance. No study so far has aimed to examine the~     possible benefits of whey protein drink in the composition of preoperative drinks.~   "
168943|NCT01354236|"~     This study aims to investigate psychosocial risk- and protective factors such as psychiatric~     disorder, socio-economic background and family functioning among school dropouts and to~     compare the findings with those by a matched control group of regularly enrolled students.~   "
168944|NCT01354223|"~     This study seeks to evaluate a new daily disposable contact lens compared to an existing~     daily disposable contact lens.~   "
168945|NCT01354210|"~     The purpose of the proposed study is to test SMS (short message service) text messaging~     technology to improve medication adherence among youth living with HIV (YLH). The proposed~     study is a randomized controlled trial of the effect of text message reminders on ART~     (anti-retroviral therapy) adherence among non-adherent YLH. Daily text message reminders will~     be sent to patients randomized to the intervention group according to their medication~     schedule, for 6 months. The investigators will enroll non-adherent YLH, ages 16-29. Half of~     the sample, randomized to the intervention, will receive daily SMS text message medication~     reminders and half will be randomized to the control condition and receive standard of care~     (SOC) only. For the controlled trial, adherence levels and viral load will be collected at~     baseline, 3-month and 6-month follow-up. In addition, at the end of the initial 6-month~     enrollment period, participants in the control condition will cross-over to the SMS~     intervention and participants in the intervention condition will cease to receive the SMS~     intervention. Adherence and viral load data will be collected from each group at 9- and~     12-month follow-up points. The investigators hypothesize that youth in the intervention~     condition will demonstrate a clinically meaningful increase in adherence at 3 and 6 months~     post-baseline, from approximately 70% to 90% adherence to ART.~   "
168946|NCT01354197|"~     The study observed the 28 days mortality of 9 participated University base surgical intensive~     care unit (SICU) as well as the occurrence of adverse events in SICU.~   "
168947|NCT01354184|"~     This is an investigation of the efficacy and safety of CRD007 compared to placebo in the~     treatment of patients with abdominal aortic aneurysm.~   "
168948|NCT01354171|"~     This is a multi-centre, prospective, randomized phase III trial to determine if~     multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible~     for active surveillance through better detection of clinically significant cancer.~   "
168949|NCT01354158|"~     The investigators seek to determine the efficacy, duration of action and safety of escalating~     dose of droxidopa on systemic blood pressure, cerebral blood flow and vasoactive hormones and~     catecholamines during upright seated posture.~      Primary Question:~      1. What is the lowest dose of droxidopa that increases seated SBP to 115±5 mmHg in men and~     105±5 mmHg in women?~        -  When does the defined increase in SBP occur after oral ingestion of droxidopa?~        -  How long does this dose of droxidopa sustain SBP at these levels?~        -  What are the vital signs and the subjective symptomology following droxidopa~          administration?~      Secondary Question:~      1. What is the MFV response to droxidopa administration in hypotensive individuals with SCI?~        -  Does an increase in SBP correspond to an increase in MCA MFV?~      Tertiary Question:~      1. What is the vasoactive hormone and catecholamine response to droxidopa administration in~     hypotensive individuals with SCI?~        -  Does droxidopa administration result in a change in APR, Aldo or NE in hypotensive~          individuals with SCI?~   "
168950|NCT01354145|"~     The main purpose of this study is to compare the cartilage volume loss at the Baseline visit~     and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN)~     1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.~   "
168952|NCT01354119|"~     Background: Aortic stent-graft is useful to occlude intimal tear and prevent further~     dilatation of the false lumen in patients with aortic dissection. The long-term benefit of~     aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well~     demonstrated, especially in patients at high risk of aneurysmal change and death.~      Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft~     insertion performed just after the acute phase into the descending thoracic aorta in patients~     with distal aortic dissection and at high risk of aneurysmal change of the dissected aorta.~   "
168954|NCT01354093|"~     Macular telangiectasia type 2 (MacTel Type 2) is an uncommon eye disorder that results in~     slow vision loss beginning in middle age. The macula is the central part of the retina, which~     lines the back of the eye like the film of a camera. The macula is responsible for central or~     reading vision. Telangiectasis refers to dilated, leaky vessels, for example varicose veins~     in the legs. One of the earliest manifestations of macular telangiectasia type 2 is an~     acquired reduction and/or redistribution of the macular pigment carotenoids at the foveal~     center. Currently, the biochemical mechanisms and clinical significance underlying these~     changes are not known, but it seems likely that better understanding of this phenomenon could~     lead to new interventions against MacTel.~      The objectives of this study are to image the maculas of MacTel subjects using two-wavelength~     autofluorescence imaging and resonance Raman imaging to target the 7-degree radius pigment~     ring characteristic of macular telangiectasia type 2 in order to gain further insight into~     the significance of this early clinical sign, and to evaluate whether supplementation with~     oral zeaxanthin can normalize macular pigment distribution in MacTel subjects~   "
168955|NCT01354080|"~     The purpose of this study is to compare the effectiveness of massage based on the tensegrity~     rule and classical abdominal massage in persons with constipation.~   "
168956|NCT01354067|"~     The chronic airflow limitation in chronic obstructive pulmonary disease (COPD) patients~     resulting in increased dyspnea during physical activity restricts many COPD patients ability~     to perform exercises in general and whole-body exercises in particular. Single limb training~     performed as one-legged cycling has been shown effective in patients with COPD. This exercise~     regime results in less stress on the ventilatory system as training is executed using a~     simultaneously smaller muscle mass. However, the positive physiological effects of exercise~     training only occur in the involved muscle(s). To be of benefit for patients daily life, all~     relevant muscles should be included in exercise training. The aim of the current randomized~     controlled multicenter trial (RCT) is to determine the effects of high-repetitive single limb~     exercises (HRSLE) in combination with COPD specific patient education, compared to the COPD~     specific patient education alone in patients with moderate to very severe (stage II-IV) COPD.~   "
168957|NCT01354054|"~     TENS is a non pharmacological intervention to control pain. Both high (>50 Hz) and low (<10~     Hz) frequency TENS are used in the clinic and it is thought that each type works through~     different mechanisms (see for review Sluka and Walsh, 2003). Hyperalgesia, an increased~     response to a noxious stimuli, is one component of pain and occurs both at the site of~     injury, primary hyperalgesia, and outside the site of injury, secondary hyperalgesia. Recent~     studies in animals with arthritis of the knee show that low and high frequency TENS~     differentially modulate primary and secondary hyperalgesia.~      Therefore the investigators hypothesize that TENS will reduce hyperalgesia and pain with~     movement resulting in increased function.~   "
168958|NCT01354041|"~     The primary objective of this pilot study is to examine the feasibility and acceptability of~     a randomized, controlled study of a mindfulness and values-based living intervention targeted~     at reducing fear of recurrence in breast cancer survivors compared to treatment as usual~     control. Furthermore, the secondary objective of this randomized, controlled pilot study is~     to determine preliminary efficacy and effect size of the mindfulness and values-based living~     intervention compared to the treatment as usual control condition in reducing fear of~     recurrence in breast cancer survivors.~   "
168959|NCT01354028|"~     Premature infants sometimes require sedation to ensure minimal movement during diagnostic~     procedures such as MRIs. However, sedatives may produce adverse effects. The purpose of this~     two-day study is to determine whether massage therapy will promote sleep in preterm infants~     and also help them to stay asleep, providing a safer way to sedate infants for procedures. A~     small instrument called a sleep watch or actigraph will be placed around the infant's ankle~     to measure muscle activity and provide an indication of sleep. Infants will receive a 10-~     minute massage on one morning of the study and no massage on the alternate morning.~     Recordings from the actigraph will show whether there is difference in sleep pattern with and~     without massage. Infants will be monitored for any heart rate and oxygen saturation changes~     on both mornings of the study.~   "
168960|NCT01354015|"~     DRMS is a system that communicates with patients via text message using cellphones, computers~     and other devices. It reminds patients about multiple health care and disease related issues~     such as to test their blood sugars and send the result back to the system via text message.~     The system will then decided based on automated algorithms whether to send another message~     advising patients on changing their medication etc.~      This pilot will enroll 100 injectible insulin dependent patients with uncomplicated Type 1~     and Type 2 diabetes mellitus, using insulin, who will be enrolled to participate in the~     pilot. Patients will be randomized 1:1 to either DRMS or standard care. The patients in the~     DRMS program will undergo interactions with the system using multiple communications channels~     including cell phones, IVR, email, web and SMS messaging. The goals of the interactive~     programs are the following:~        1. Monitor and intervene to remind patients to fill their prescriptions~        2. Monitor and track insulin unit consumption utilization and timing of that dosage~        3. Monitor and intervene when the patient does not use or take their medications as~          prescribed.~        4. Monitor and track insulin unit consumption and timing of that dosage~        5. Ask the patient for their glucose levels and then provide customized information to the~          patients regarding how to modify their medication to achieve the desired glucose level~        6. Deliver automated dose adjustment directions based on the providers instructions~        7. Coordinate personalized educational programs and messages into the automated~          intervention programs~        8. Provide feedback to the patients, including performance and reinforcement to both~          providers and to patients.~        9. Provide feedback to providers on patients performance as well as exception based~          reporting~      The System will manage interventions in an automated fashion. Providers will intervene on an~     exception basis and only when automated interventions have not worked or the protocol~     requires immediate action by the provider. For example, if the glucose exceeds certain danger~     levels, as defined by the provider, a requirement might be to call and notify the doctor~     immediately.~   "
168961|NCT01354002|"~     The aims of this protocol are: to collect and store diseased and normal tissue and body fluid~     samples from new and returning patients at St. Jude Children's Research Hospital (SJCRH),~     affiliated sites and collaborating institutions; to collect and store samples from relatives~     of SJCRH patients; to collect and store retrospective and prospective pertinent corresponding~     clinical and laboratory data on disease characterization, treatment, and outcome; and to~     serve as a source of human biological samples and corresponding laboratory and clinical data.~   "
168974|NCT01353833|"~     IL-2 is an inducer of regulatory T cells (Treg), a population of lymphocytes that fail to~     control the autoimmune destruction of beta-cells in patients with Type 1 Diabetes (T1D). The~     investigators recently showed that low dose IL-2 is well tolerated in patients with an~     autoimmune disease. The investigators aim to use IL-2 to induce/stimulate Treg in T1D~     patients. This study will investigate the dose effect relationship of low dose IL-2 for Treg~     induction such as to optimize the risk benefit ratio for this treatment in T1D. By Treg~     induction, the investigators aim to protect the remaining/regenerating β-cells from~     autoimmune destruction, thus improving or even curing T1D.~   "
168962|NCT01353989|"~     A lot of elderly people travel to hepatitis A endemic areas. The prevalence of hepatitis A~     IgG positivity is declining in the Netherlands, also in the elderly. Studies show that people~     above 40 years of age have a slower immune response to hepatitis A vaccination. However, a~     lot of travelers seek pre-travel advice only shortly before their journey. More information~     about the time to adequate antibody response after hepatitis A vaccination is required to~     provide good protection during travelling. Alternative protection with immunoglobulins are~     available.~      Study design: Observational, longitudinal pilot study Study population: 20 adults over 60~     years of age with a negative hepatitis A IgG, (with a estimated 50% positivity for hepatitis~     A IgG in this age Group, 40 patients in this age group) 20 adults 18-40 years of age as~     controls.~      Intervention (if applicable): When hepatitis A vaccination is indicated and informed consent~     is obtained, hepatitis A IgG wil be measured at day 0, 7, 14, 21 en 28.~      Main study parameters/endpoints: Time to protective hepatitis A IgG. Nature and extent of the~     burden and risks associated with participation, benefit and group relatedness: hepatitis A~     vaccination will be given also outside this study. In the study 5 venous punctures of 7 ml of~     blood.~   "
168963|NCT01353976|"~     This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam~     vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is~     a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.~   "
168964|NCT01353963|"~     This is a non-interventional study to review safety data on administration of desvenlafaxine~     succinate among Filipino patients with MDD and VMS per usual clinical practice within the~     first three years post commercial distribution.~   "
168965|NCT01353950|"~     The purpose of this study is to investigate the expression of a certain class of molecules,~     called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic~     disorder which renders the lung susceptible to persistent inflammation which, at times, can~     worsen, resulting in accelerated decline in lung function and eventually death or transplant.~     Our goal is to determine if the levels of costimulatory markers can be used to predict~     exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.~   "
168966|NCT01353937|"~     Diabetic foot ulcers, a complication of diabetes leading to 80.000 lower limb amputations~     annually in the US, are a significant burden to our health system, costing more than a~     billion dollars annually. Here, we propose a novel combination of two drugs (Mozobil® and~     Regranex®Gel) to mobilize a specific sub-type of stem cells (endothelial progenitor cells)~     from the bone marrow and traffic them toward the wound, increasing the blood supply that~     subsequently improves wound healing. Because we are using the human body's own resources to~     regenerate itself by targeting and correcting the underlying pathophysiology, we believe that~     this novel therapy yields great promise in the treatment of diabetic foot ulcers.~   "
168967|NCT01353924|"~     The only disease-modifying treatment for allergic disorders nowadays is allergen-specific~     immunotherapy (SIT). To induce hyporesponsiveness increasing doses of the disease-eliciting~     allergens are applied. One major problem of this treatment is, that it has to combat with an~     already established immune response against the disease-eliciting allergen. To circumvent~     this problem the investigators want to perform the proof of principle study towards~     prophylactic treatment. Prophylactic vaccination is used since many years for many infectious~     diseases. The investigators want to adopt this successful principle for the treatment of type~     I allergies.~      For this purpose non-allergic healthy individuals will be immunized with adjuvant-bound~     hypoallergenic derivatives of the major birch pollen allergen, Bet v 1. As usual for~     allergen-specific immunotherapy, injections will be applied subcutaneously. Three injections~     in one-monthly intervals will be given to establish the immune response and a further~     injection after one year will determine how the vaccine-induced immune response can be~     boosted.~      The vaccine will be composed of an equimolar mixture of two adjuvant-bound hypoallergenic~     derivatives of the major birch pollen allergen, Bet v 1. The first investigational product~     (IP) designated as Bet v 1aF1 is a protein of 73 amino acid residues and represents the first~     half (1-73aa) of the Bet v 1 molecule. The second IP, Bet v 1aF2, is a protein of 86 amino~     acid residues and represents the second half (74-160aa) of Bet v 1. Both proteins are~     expressed in Escherichia coli. The hypoallergenic derivatives lost their IgE binding~     capacities by the disruption of the conformational IgE epitopes of the Bet v 1 molecule.~      In several preclinical and clinical studies it has been shown that the two hypoallergenic~     fragments, Bet v 1aF1 and Bet v 1aF2 have a strongly reduced allergenic reactivity and almost~     no sensitization potential, requisite for a prophylactic treatment. In a multi-centre~     placebo-controlled double blind clinical trial including 124 allergic patients no relevant~     sensitization against new epitopes could be observed after vaccination of the Alum-bound Bet~     v 1 derivatives.~      In contrast, the vaccine induced a strong IgG response in animals as well as in clinical~     studies. Vaccine-induced antibodies showed protective properties as they could inhibit the~     binding of allergic patients' IgE. An improvement of clinical symptoms and a reduction of the~     skin reactivity was correlated with an increase of IgG antibodies and could be shown only in~     actively treated patients in a multi-centre placebo-controlled double blind clinical trial.~      The investigational products will be tested in a Phase I clinical trial for prophylactic~     allergy vaccination in healthy non-allergic subjects. The two IPs will be coupled either to~     Alum and an equimolar mixture will be injected subcutaneously. The immune responses will be~     compared to placebo. In total 20 non-allergic healthy male subjects (10 per group) will be~     included in this clinical trial. For safety precautions the subjects will be monitored by~     skin prick testing using the two uncoupled IPs and commercial birch pollen extract in short~     intervals to recognize possible vaccine-induced sensitizations. The primary endpoint of phase~     I clinical trial is the evolution of Bet v 1-specific and Bet v 1 fragment-specific IgG1-4,~     IgE and IgM antibody levels in serum and in nasal fluids after vaccination of rBet v 1~     derivatives.~   "
168968|NCT01353911|"~     This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir~     (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin~     (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.~   "
168969|NCT01353898|"~     This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of MK-1972 in participants with HIV-1 infections. In Part 1, participants~     will be randomized to receive MK-1972 (at one of 5 different dose levels given once or twice~     per day) or placebo. Part II will begin after the results of Part I are known; participants~     will be randomized to receive MK-1972 (only one dose level, twice per day) or placebo. The~     primary hypotheses are that MK-1972 at the studied doses is safe and well tolerated in HIV-1~     infected males; and that MK-1972 has superior antiretroviral activity compared to placebo.~   "
168970|NCT01353885|"~     Osteoarthritis disables approximately 10% of people who are 60 years or older and compromises~     the quality of life of more than 20 million Americans every year. Osteoarthritis is caused by~     the breakdown of cartilage that lines the bones at your joints from daily wear and tear and~     results in pain and restricted function. Total hip arthroplasty (THA) or total hip~     replacement, is currently one of the most successful and cost-effective treatments used to~     eliminate pain and restore function in those suffering from osteoarthritis. There are~     multiple ways to perform a THA. The main difference between each type is the point of~     incision in relation to a muscle on the outer surface of your hip bone: gluteus medius. The~     incision performed can be anterior (in front of the muscle), anterolateral (in front and to~     the side of the muscle), or posterior (from the back). Each of these approaches has its own~     advantages and disadvantages, but there is no evidence available that makes one better than~     the other. The purpose of this study is to determine which of the three approaches to THA is~     the most effective. The main outcome that will determine the most effective approach is the~     functional ability of the patients included in this study at 52 weeks. The investigators will~     also compare whether the patient's: length of hospital stay, use of assistive devices, need~     for revision surgery, ability to return to work, ability to relieve pain, complication rate,~     and quality of life. The investigators hypothesize that the anterior approach will be the~     most effective approach in reducing the rate of post-operative complications after THA.~   "
168971|NCT01353872|"~     The main objective of this study is to investigate the effects of ingestion of different~     sports drinks (Nutrattente / Nutraperf / Nutrarecup) on fatigue induced by a tennis~     tournament simulation.~   "
168972|NCT01353859|"~     This multicenter, open-label, single arm study will assess the safety and efficacy of~     RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active~     rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying~     antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously~     every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly.~     Anticipated time on study treatment is 24 weeks.~   "
168973|NCT01353846|"~     The purpose of this study is to compare the natural cycle (without any medication) with the~     well-established artificial cycle in an egg donation program.~   "
168975|NCT01353820|"~     The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis~     (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol~     concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus~     control product.~   "
172221|NCT01310933|"~     The purpose of this study is to differentiate Kikuchi's disease and malignant lymphoma by~     soft tissue ultrasound.~   "
168976|NCT01353807|"~     The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of~     long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant~     women, while they were in gestational week 30, were randomized to fish oil supplements~     providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no~     supplements; they were asked to take the supplements until delivery. Health outcomes were~     assessed during pregnancy and delivery. Further, offspring health and development has been~     examined during the ensuring two decades by making linkages to the rich Danish health and~     administrative registries, by asking the offspring to complete web-based questionnaires, and~     by examining the offspring physically.~   "
168977|NCT01353794|"~     The objective of this Non-Interventional study is to evaluate the effectiveness & safety of~     Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions~     based on age of the patient (older (age >70 years) and younger patients (age <70 years).~     Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of~     cycles) and incidence of Hand foot Skin Reaction.~   "
168978|NCT01353781|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing~     schedules in Japanese patients with advanced solid malignancies.~   "
168979|NCT01353768|"~     GSK is conducting a global retrospective chart review of patients treated with zanamivir as~     part of the Compassionate Use Program (CUP), in an effort to collect as much information as~     possible on the use of this investigational drug. The retrospective chart review is intended~     to gain a better understanding of the safety profile of investigational zanamivir and of~     clinical outcomes in the large number of patients treated outside of a clinical trial~     setting.~   "
168980|NCT01353755|"~     To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail~     of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with~     rhinoconjunctivitis caused by grass pollen with/without controlled asthma.~   "
168981|NCT01353742|"~     This is a phase I study being conducted to support the clinical development program of a FDC~     product of the nucleoside analogue lamivudine and the nucleotide analogue adefovir dipivoxil.~     To establish bioequivalence, the exposure of lamivudine and adefovir dipivoxil when~     administered as the FDC will be compared to that of Heptodin (lamivudine) and Hepsera~     (adefovir dipivoxil) when administered separately. In this study, the FDC product will~     contain 100mg lamivudine/10mg adefovir dipivoxil.~      Total 40 healthy adult subjects will be enrolled. The study will include a screening visit~     and two treatment sessions. The screening visit will be conducted up to 3 weeks prior to the~     first dose of Session 1. All subjects will receive Regimen A through B according to the~     randomization schedule. Eligible subjects will be enrolled in the study and randomized to~     receive the following treatment regimens in table below in one of the following treatment~     sequences: AB, or BA. There will be a seven to ten days washout period between each treatment~     session. Pharmacokinetic sampling for measurement of plasma lamivudine and adefovir dipivoxil~     concentrations will be conducted over a 48-hour period following the morning administration~     of study medication in each study session. During this time, all subjects will remain in the~     unit for pharmacokinetic (PK) sample collection. The total duration (from screening to the~     end of the study) of each subject's participation will be approximately four weeks.~   "
168982|NCT01353729|"~     Approximately 40 healthy subjects will be enrolled. Each subject will participate in the~     study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day~     washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each~     dosing period and will remain in the unit until Day 2. Each subject will receive a single~     dose of each of the four treatments on Day 1 of each treatment period in a randomized~     fashion. Subjects will be discharged from the clinical research unit after the completion of~     all assessments on Day 2 of each period and return approximately 5-7 days later for the next~     dose period. Serial pharmacokinetic samples will be collected for up to 24 hours following~     each treatment.~   "
168983|NCT01353716|"~     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor being developed for the treatment of~     human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of~     Shionogi-ViiV Healthcare LLC. DTG is metabolized primarily by uridine diphosphate~     glucuronyltransferase (UGT)1A1, with a minor role of cytochrome P450 (CYP)3A, and with renal~     elimination of unchanged drug being extremely low (< 1% of the dose). Fifty-three percent of~     the total oral dose is excreted unchanged in the feces but it is unknown if all or part of~     this is due to unabsorbed drug or some percentage of biliary excretion of the glucuronide~     conjugate which can be further degraded to form the parent compound in the gut lumen. The~     current Food and Drug Administration (FDA) draft guidance for renal impairment studies states~     that a pharmacokinetic (PK) study in patients with renal impairment should be conducted even~     for those drugs primarily metabolized or secreted in bile, because renal impairment can~     inhibit some pathways of hepatic and gut drug metabolism and transport.~      This study is planned as an open label, single-dose, pharmacokinetic study to evaluate plasma~     DTG pharmacokinetics following oral administration to subjects with severe renal impairment~     (creatinine clearance < 30 ml/min) and matched healthy controls. Results from this study are~     expected to enable the development of appropriate dosing recommendations in patients with~     renal impairment.~   "
168984|NCT01353703|"~     This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when~     administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks~     or a 2-4-6 months schedule.~   "
168985|NCT01353690|"~     The aim of this clinical study is to investigate the safety and feasibility of Autologous~     Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for~     patients with advanced heart failure caused by ischemia.~   "
168986|NCT01353677|"~     This is a multi-institution, non-randomized, prospective pilot study to evaluate the~     feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult~     allogeneic Hematopoietic stem cell transplantation (HCT) recipients.~   "
168987|NCT01353664|"~     This study is intended to provide access to Romidepsin for participants who received~     Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and~     for participants whom the investigator feels may benefit from continuing treatment with~     Romidepsin.~   "
168988|NCT01353651|"~     Even though the indication for endovascular therapy has been enlarged, open repair of common~     femoral artery is still considered as the treatment of choice. A recent pilot study showed~     that endovascular repair of the CFA seems to be a safe technique of revascularization with~     acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in~     press). TECCO, a French randomized and controlled trial, has been set up to compare open and~     endovascular procedures for the treatment of CFA atherosclerotic lesions.~   "
168989|NCT01353638|"~     Peritoneal dialysis (PD) is a cost effective and safe form of renal replacement therapy in~     patients suffering from end stage renal disease.~      However currently available PDF (peritoneal dialysis fluids) are not biocompatible for the~     peritoneal cavity and its cells. Acute cytotoxic effects of the majority of the current~     glucose-based PDF are caused by low pH, lactate, high glucose and its degradation products~     (GDP).~      Toxic effects of PDF can thus be extended to suppression of mesothelial HSR (heat shock~     reactions) following PDF exposure resulting in increased susceptibility of mesothelial cells~     against PDF exposure: PDF inherent stress factors fail to adequately induce HSP as effectors~     of the cellular stress response - the adequate HRS rather seems to be blocked.~      Hence, therapeutic approaches to activate and enhance the HSR will reduce peritoneal damage~     and organ failure and improve the survival of organisms.~      Preclinical results demonstrated that supplementation of PDF with pharmacological doses of~     alanyl-glutamine restored HSP expression and increased the resistance of mesothelial cells in~     in-vitro models of PD and preserved peritoneal integrity in in-vivo models of PD.~      After these positive preclinical results, this study shall now clarify, whether the addition~     of alanyl-glutamine to the most commonly used glucose-based PDF is safe and tolerable.~     Therefore PDFs will be drained in a randomized cross-over study. Main outcomes measures will~     be total HSP expression in peritoneal cells and changes of the peritoneal transport kinetics~     and the presence/absence/severity of side effects.~   "
168990|NCT01353625|"~     The main purpose of this first human study with CC-115 is to assess the safety and action of~     a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with~     advanced tumors unresponsive to standard therapies and to determine the appropriate dose and~     tumor types for later-stage clinical trials. The bioavailability of tablet and capsule~     formulations under fasting and fed conditions will also be evaluated in some patients.~   "
168991|NCT01353612|"~     This is a prospective, multi-center imaging study expecting to enroll approximately 1350~     patients scheduled for clinically-indicated coronary angiography. Following informed consent,~     patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and~     non-invasive ultrasound imaging of their carotid arteries. Following a 2-year follow-up~     period, patients will undergo repeat coronary IVUS and standard invasive coronary angiography~     as well as carotid ultrasound examination.~      Additionally, patients will be contacted by phone on an annual basis for 5 years to collect~     cardiovascular and cerebrovascular clinical endpoints. Evaluations of plaque burden will be~     made using invasive and non invasive imaging tools in order to assess correlations between~     vascular beds, imaging technologies and main cardiovascular events.~   "
168992|NCT01353599|"~     Individuals with chronic cervical SCI are known to have a restrictive ventilatory defect due~     to complete or partial loss of respiratory muscle innervation which is dependent upon the~     level and completeness of injury [2]. In addition, they share many aspects of obstructive~     airway physiology commonly associated with asthma. In asthma, physiological responses such as~     decrease in baseline airway caliber, bronchodilatation following inhalation of a~     beta-2-adrenergic agonist or anticholinergic agent, airway hyperreactivity, are all closely~     related to airway inflammation. The cause of such inflammation is unclear, and may be~     multi-factorial and attributable to: recurrent respiratory infections due to inability to~     effectively clear secretions, unopposed parasymphathetic innervation, and loss of functional~     sympathetic innervation to the airways. Therefore, the investigators propose to test for the~     possible involvement the above mechanisms by pharmacological intervention, and to study~     effects of such intervention on overall pulmonary function and indirect measures of pulmonary~     inflammation: levels of FeNO, exhaled breath condensate (EBC) inflammatory biomarker profile,~     pulmonary function tests, and cellular profile of the induced sputum.~   "
168993|NCT01353586|"~     The purpose of this study is to assess the safety and effectiveness of the Circular and~     Crescent Mapping and Ablation catheters and the workflow of the Multi-Electrode Irrigated~     Pulmonary Vein Isolation System when used for the treatment of drug refractory symptomatic~     paroxysmal atrial fibrillation (PAF).~   "
168994|NCT01353573|"~     Radiosurgery is precisely delivered high dose radiation. It can be performed using multiple~     cobalt sources, a modified traditional gantry-based linear accelerator or a robotic linear~     accelerator. The treatment of brain metastases represents the most common indication for~     radiosurgery while new indications for this technology are continually being discovered. With~     the increasing importance of radiosurgery and the resource implications for radiotherapy~     programs the investigators have proposed the first direct technological comparison of robotic~     to linear accelerator radiosurgery for brain metastases.~   "
168995|NCT01353560|"~     Despite widespread and growing popularity of complementary and alternative medicine (CAM) in~     the US, there currently exist significant gaps in our knowledge regarding CAM use, clinical~     effectiveness, safety and cost- effectiveness. With previous funding support from NCCAM, the~     Harvard Medical School (HMS) Osher Research Center established and trained a~     multidisciplinary integrative team of CAM and conventional providers to work collaboratively~     to provide state-of-the-art integrative care in a coordinated and individualized fashion.~     The Osher Integrative Care Center (OCC) was opened in fall 2007, physically located within~     the Ambulatory Care Center of the Brigham and Women's Hospital (BWH) at 850 Boylston Street~     in Chestnut Hill, MA. The focus of this survey study is to characterize the decision-making~     process of both patients and conventional providers with respect to communication about and~     referral to an integrative care team in an academic hospital outpatient setting.~   "
169007|NCT01353404|"~     The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate~     160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.~   "
169038|NCT01353001|"~     The purpose of this study is to examine the effect of weight loss and exercise on~     cardiovascular disease risk factors, specifically inflammation as measured by C-Reactive~     Protein and cardiac structure and function as measured by cardiac MRI, in Class II and III~     obese women during a 12 week training intervention.~   "
168996|NCT01353547|"~     The purpose of the research study is to identify the genetic, environmental and immune~     profiles that may increase a person's risk of developing multiple sclerosis (MS). While MS is~     not a disease caused by a single variation in genetic material (DNA), a single environmental~     factor, or a single malfunction in immune cells, there are genetic alterations, environmental~     exposures and immunologic factors that make the development of MS more likely. Obtaining~     information about who is at risk for MS will be beneficial in the future if the investigators~     can identify effective ways to prevent or slow down the progression of this disease.~   "
168997|NCT01353534|"~     Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg~     A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will~     receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered~     IM but followed by the topical application of a VEP at the vaccination site. Group 4 will~     receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of~     a VEP at the vaccination site.~      The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)~   "
168998|NCT01353521|"~     Complex renal cysts are often incidentally detected on imaging. The differential diagnosis of~     the complex renal cyst includes various benign cystic lesions, which are based on the Bosniak~     classification scheme. Currently the standard of care in evaluating a complex renal cyst is~     using a contrast-enhanced computed tomography (CT) scan, or a contrast-enhanced magnetic~     resonance imaging (MRI) scan. Since both of these modalities present adverse events due to~     frequent high doses of radiation, a technique such as a contrast-enhanced ultrasound (CEUS)~     can be used to obtain the same results, without having to impose high doses of radiation upon~     a patient.~   "
168999|NCT01353508|"~     Assess mechanism of action of LCZ696 related to sodium excretion.~   "
169000|NCT01353495|"~     Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM)~     in 12 weeks.~   "
169001|NCT01353482|"~     Mesothelioma is a relatively rare cancer which is becoming more common. It can affect one of~     two areas; the pleura (the lining of the lung) or the peritoneum (the lining of the abdomen).~     Cancer affecting the pleura is the more common of these and is called Pleural Mesothelioma.~     This is most commonly caused by exposure to asbestos.~      Unfortunately mesothelioma is usually diagnosed at an advanced stage and so treatment is~     based around controlling the disease and managing the symptoms, rather than curing the~     disease.~      The standard treatment for Advanced Malignant Pleural Mesothelioma is a combination of two~     anticancer drugs; Pemetrexed and Cisplatin.~      The trial will look into whether there are benefits of adding a third drug called Vorinostat~     to the treatment.~   "
169002|NCT01353469|"~     Primary Objective:~      To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a~     24-week treatment period in patients with type 2 diabetes mellitus.~      Secondary Objectives:~        -  To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2~          diabetes mellitus on fasting plasma glucose (FPG)~        -  To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in patients~          with type 2 diabetes mellitus~   "
169003|NCT01353456|"~     Recently, multimodal approach for postoperative pain control has been advocated.Combinations~     of traditional and novel pharmacological agents are administered, aiming to improve~     analgesia, spare opioid consumption, minimise adverse effects, and improve postoperative~     bowel function in colorectal surgery.~      One of the novel agents suggested is dexmedetomidine. It is a selective alpha-2 adrenoceptor~     agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing~     effects. Furthermore, a significant reduction in postoperative morphine consumption by using~     patient-controlled analgesia (PCA) has been achieved when dexmedetomidine was administered~     before operation. The drug also reduces cate-cholamine secretion, thereby reducing stress and~     leading to a modest reduction in heart rate and blood pressure, which may be particularly~     beneficial in patients with cardiovascular disease, while respiratory rate is not affected.~      In this study, the investigators would like to evaluate the analgesic effects of~     dexmedetomidine, which is administered intraoperatively with morphine, followed by~     postoperative PCA morphine infusion, for postoperative pain for open and laparoscopic~     colorectal surgery. Cyclooxy-genase-2 (COX-2) inhibitors and rescue intramuscular pethidine~     will also be incorporated as part of the multimodal analgesia regimens.~      Good pain control can help to decrease cardiovascular complications. Emerging data has~     suggested a key role of soluble CD40L as inflammatory mediators of atherosclerotic lesion~     progression. The investigators would like to evaluate the effect of our analgesic regimens on~     soluble CD40L peri-operatively.~      The investigators hypothesize that intraoperative dexmedetomidine can reduce postoperative~     pain and improve recovery and outcomes.~   "
169004|NCT01353443|"~     AIDA Study is a prospective, multicentre, randomized, controlled clinical investigation with~     patients undergoing median laparotomy for Abdominal Aortic Aneurysm (AAA) repair.~      The primary objective of the clinical investigation is to test the hypothesis that insertion~     of an Optilene® Mesh Elastic mesh - a monofilament, light-weight, large pore sized,~     polypropylene mesh manufactured by Aesculap AG - is superior to suturing alone and will~     reduce the hernia formation rate within the first 2 years.~      A reduction from 30% to 10% of the patient population is assumed.~   "
169005|NCT01353430|"~     The investigators are researching families with inherited inclusion body myopathy (IBM)~     and/or Paget disease of bone (PDB) and/or dementia (FTD) which is also called IBMPFD. IBMPFD~     is caused by mutations in the VCP gene. Our main goal is to understand how changes in the VCP~     gene cause the muscle, bone and cognitive problems associated with the disease.~      The investigators are collecting biological specimen such as blood and urine samples, family~     and medical histories, questionnaire data of patients with a personal or family history of~     VCP associated disease. Participants do not need to have all symptoms listed above in order~     to qualify. A select group of participants may be invited to travel to University of~     California, Irvine for a two day program of local procedures such as an MRI and bone scan.~      Samples are coded to maintain confidentiality. Travel is not necessary except for families~     invited for additional testing.~   "
169006|NCT01353417|"~     This non-interventional study intends to collect epidemiological data in patients with stable~     kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the~     approved indication.~   "
169008|NCT01353391|"~     Insulin is the standard treatment for the management of type 2 diabetes in pregnancy, however~     despite treatment with insulin, these women continue to face increased rates of adverse~     maternal and fetal outcomes. The investigators hypothesize that metformin use, in addition to~     treatment with insulin, will help with blood sugar control, lower the dose of insulin needed,~     lower weight gain, and improve baby outcomes.~   "
169009|NCT01353378|"~     The purpose of this study is to determine whether dexmedetomidine is effective in the~     treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.~   "
169010|NCT01353365|"~     Acute dyspnea and chest discomfort are common complaints. Distinguishing between the entities~     that may present with such symptoms can be difficult. This project aims to study - venous~     thromboembolism (VTE) - a difficult diagnosis that can easily be missed yet its treatment is~     highly effective.~      VTE represents a spectrum of disease ranging from deep vein thrombosis to pulmonary embolism~     (PE). Early diagnosis of PE is usually based on suspicion raised by clinical symptoms~     combined with a medical history of obvious predisposing factors. However, in around 30% of~     cases PE occurs in the absence of any predisposing factors. Individual clinical signs and~     symptoms are neither sensitive nor specific.~      PE is generally associated with hypoxaemia, but up to 20% of patients with PE have a normal~     arterial oxygen pressure .Classic ECG changes are generally associated with the more severe~     forms of PE.~      Bio-markers such as Plasma D-dimer (DD) have been investigated extensively in recent years.~     It has been shown that a normal DD level renders acute PE or DVT unlikely; on the other hand~     DD is not useful for confirming VTE.~      CT angiography(CTA) has become the method of choice for imaging the pulmonary vasculature for~     suspected PE. Yet as in DD the pre-test probability of PE based on the clinician's abilities~     highly affects the results of the CT.~      While VTE is a fairly common and sometimes lethal condition its diagnosis is difficult and~     based more on clinical hunches than on highly sensitive and specific diagnostic tools. It's~     quite evident that finding a novel, sensitive and even more importantly specific biomarker~     for PE would change the current approach and work-up needed for reaching a diagnosis.~      We propose using serum levels of surfactant associated protein (SAP) as such a bio-marker.~     Surfactant is a unique phospholipoprotein secreted solely by type II alveolar cells in the~     lungs. About 90% of the surfactant structure is composed of phospholipids and the remaining~     10% is composed of specific proteins.~      Working hypothesis and aims: PE causes ischemic damage to lung tissue. Such damage will~     ultimately lead to a rise of serum SPA. The primary objective of this project is to ascertain~     the fact that indeed there is a rise of serum SPA among patients diagnosed with PE, what is~     the time-concentration profile of such rise and is the rise correlated to the size of the~     embolus.~      Methods: The study will be designed as a prospective study consisting of several steps. The~     measurement of serum SPA will be done by commercially available ELISA kits. All patients will~     be enrolled by researchers from both the ER and internal B ward at the Rambam Medical Center.~      Probable implications to Medicine: If indeed SPA levels will be proven to be a novel~     bio-marker for PE this could ultimately lead to a totally different approach in the~     classification and treatment of patients presenting with signs that may be associated with~     PE.~   "
169011|NCT01353352|"~     Neck injuries are a common problem among blunt trauma victims with more than 8,000,000 cases~     being seen annually in U.S. and Canadian EDs. While the majority of these cases represent~     soft tissue injuries, 30,000 patients suffer cervical spine fractures or dislocations and~     approximately 10,000 suffer spinal cord injury. There are no readily available national~     Canadian data on ED visits such as those provided by the U.S. National Hospital Ambulatory~     Medical Care Survey. The prevalence of potential neck injury can, however, be reasonably~     estimated for Canadian EDs. Extrapolation, on a population basis, from reliable U.S. figures~     suggests that 1.3 million potential neck injury patients are seen annually in Canada. Only~     0.9% of these patients are found to have cervical spine fractures or dislocations.~   "
169012|NCT01353339|"~     Primary Research Questions:~      Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be~     assessed.~        1. Under efficacy, this pilot will determine whether levofloxacin can decrease the~          incidence of BK viruria and peak urine BK viral load.~        2. Under safety, this pilot will determine the incidence of adverse events with~          levofloxacin.~        3. Under feasibility, this pilot will determine the number of kidney transplant patients~          randomized over an eight month enrolment period, adherence to the levofloxacin and~          frequency of patient drop-out and loss to follow-up~   "
169013|NCT01353326|"~     The purpose of this study is to compare the bone mineral density of patients who have~     undergone either cemented or cementless hip resurfacing.~   "
169014|NCT01353313|"~     The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course~     of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who~     are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or~     placebo. This study will determine if hydrocortisone improves infants'survival without~     moderate or severe BPD and will be associated with improvement in survival without moderate~     or severe neurodevelopmental impairment at 22 - 26 months corrected age.~   "
169015|NCT01353300|"~     RATIONALE: The identification of gene mutations in young patients with pleuropulmonary~     blastoma syndrome may allow doctors to better understand the genetic processes involved in~     the development of some types of cancer, and may also help doctors identify patients who are~     at risk for cancer.~      PURPOSE: This research study studies gene mutations in samples from young patients with~     pleuropulmonary blastoma syndrome at risk for developing cancer.~   "
169016|NCT01353287|"~     The primary objective of this clinical trial is to evaluate safety of patients who underwent~     Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped transmission~     as compared to those without procedure transmission.~   "
169017|NCT01353274|"~     Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in~     patients with Hypertension~   "
169018|NCT01353261|"~     This study is being done to learn more about platelet reactivity (how well the small cells in~     the bloodstream work) in people who undergo Percutaneous coronary intervention (PCI) for~     stable and unstable (acute myocardial infarction) indications. Stable means you have not~     demonstrated any acute injury to your heart prior to your PCI; unstable means you have~     demonstrated some acute injury to your heart prior to your PCI. The investigators intend to~     determine if there is a change in platelet reactivity from the time of PCI to 30days post-PCI~     and does this change differ depending upon the conduction in which you present for PCI. This~     is going to be done with a variety of platelet reactivity assays.~   "
169019|NCT01353248|"~     The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when~     given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and~     tolerable in the treatment of Chronic Genotype 1 HCV Infection.~   "
169020|NCT01353235|"~     Evaluation of systematic administration of oral prednisolone (1mg/Kg/day) as an add on~     therapy in Chronic Obstructive Pulmonary Disease (COPD) patients admitted to intensive care~     unit (ICU) for severe exacerbation of COPD. Patients with pneumonia are excluded.~      Randomization is stratified according to ventilatory support: non invasive or conventional~     ventilation.The major outcome is the ICU mortality rate in overall population and stratified~     according to ventilatory mode (noninvasive ventilation (NIV) versus conventional).~      Secondary outcomes are superinfection necessitating a new antibiotic course, Length of~     mechanical ventilation (MV) (and ventilatory free days), Length of ICU stay, The frequency of~     gastric bleeding episodes that of frequency of hyperglycemic episodes.~   "
169021|NCT01353222|"~     This study was conducted to examine survival, disease-free survival, safety, and the~     magnitude of the immune response induced following administration of DN24-02 in subjects with~     HER2+ urothelial carcinoma.~   "
169022|NCT01353209|"~     The hypothesis in this study is that estrogen suppression by an aromatase inhibitor in~     postmenopausal women with Lymphangioleiomyomatosis (LAM) will prevent or delay progression of~     lung disease and result in a decrease in the rate of decline in FEV1~   "
169036|NCT01353027|"~     The purpose of this study is to characterize the safety and pharmacology of single~     administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.~   "
169037|NCT01353014|"~     This study's primary objective is to determine if providing individuals with personal genetic~     information impacts dietary intake behaviour. Specifically, the investigators will be~     examining whether providing dietary advice based on genes that affect the metabolism of or~     sensitivity to caffeine, vitamin C, sugar and sodium will impact the intake of these dietary~     components. The study hypothesis is that providing dietary advice based on genetics will~     impact dietary behaviour to a greater extent than general dietary recommendations.~   "
169676|NCT01344629|"~     To investigate the bioequivalence of telmisartan administrated in two different ways: both in~     telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg~     tablet and amlodipine 5 mg tablets (R) in concomitant use~   "
169023|NCT01353196|"~     Carotid artery plaques are known to cause stroke. Cognitive impairment is an insidious but~     poorly understood problem in patients with carotid plaques. Cognitive function describes how~     people perform mental processes such as thinking, learning and problem solving. Asymptomatic~     carotid plaques may affect 1 million Veterans who may be at risk for cognitive impairment. In~     this study, the investigators will uncover the extent of cognitive impairment in Veterans~     with carotid stenosis who are currently labeled asymptomatic. Programs to prevent or~     mitigate cognitive impairment will depend on identifying the mechanisms by which this occurs.~     The investigators will use sophisticated 3D imaging techniques developed by the group to~     measure the structure and composition of plaques, number of particles breaking off from them,~     blood levels of chemicals that could disrupt them, and blood flow restriction to the brain~     from them. This will help identify patients at risk for cognitive impairment who may benefit~     from preventative measures and improve selection of patients to decrease unnecessary surgical~     procedures.~   "
169024|NCT01353183|"~     The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and~     other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy)~     based upon the detection of pathological alpha-synuclein species in routine colonoscopic~     biopsies.~   "
169025|NCT01353170|"~     The study was designed in order to investigate the effects of 3 different dialysate calcium~     concentrations may exert on mineral metabolism and hemodynamic stability in standard~     hemodialysis (hd).~   "
169026|NCT01353157|"~     Cardiac surgery with cardiopulmonary bypass (CPB) and hepatic surgery are major operations,~     associated with a systemic inflammatory response syndrome. The aim of this study is to assess~     the effectiveness of clinical scoring systems and inflammatory cytokine levels for predicting~     systemic inflammation. This correlation might identify peri-operative clinical outcomes, then~     forecast further systemic inflammation in cardiac and hepatic surgical patients.~   "
169027|NCT01353144|"~     Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of~     aspirin-related peptic ulcers.~   "
169028|NCT01353131|"~     Prevention of myocardial functional deterioration and sudden cardiac death among individuals~     of intermediate risk remains one of the most elusive frontiers of contemporary medicine.~     While most of these individuals are known to have had contact with the medical system, they~     are frequently not considered to be at high risk until far advanced along one or multiple~     disease processes leading to irreversible myocardial loss and electric instability. The goal~     of this proposal is to determine the prognostic power of combining specific measures of~     ventricular architecture, myocardial structure and electrical function for the early~     identification of individuals at risk to develop ventricular arrhythmias and progressive~     myocardial failure leading to severe cardiovascular outcomes and death.~   "
169029|NCT01353118|"~     Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations~     can cause rapid and uncontrolled reductions in blood glucose. There is limited information on~     whether:~        -  metabolic surgery is superior to modern medical care for glycaemic control and type 2~          diabetes remission.~        -  metabolic surgery is safe for microvascular complications of Type 2 diabetes~        -  good glycaemic control pre surgery has any effects on the long term glycaemia and~          complications of type 2 diabetes.~      This study aims to assess:~        1. whether metabolic surgery is better for diabetes control compared to medical treatment.~        2. whether metabolic surgery is safe for eye, nerve and kidney complications.~        3. whether good sugar control before metabolic surgery improves the long term effects of~          sugar control and microvascular complications.~   "
169030|NCT01353105|"~     Only about 15% of the potential candidates for lung donation are considered suitable for~     transplantation. A new method for ex vivo lung perfusion (EVLP) has been developed and can be~     used for evaluation and reconditioning of marginal and unacceptable lungs. The ´purpose of~     this study is to analyse the executability and safety of ex vivo lung perfusion pulmonary ex~     vivo in marginal donors.~   "
169031|NCT01353092|"~     In this study patients with treatment resistant depression, as defined by Harold Sackeim, is~     subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment~     (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are~     randomized into two groups. In group A patients receive active treatment both morning and~     afternoon. In group B patients receive one sham and one active treatment. The study is~     double-blind as neither the assessors or patients are aware of treatment allocation. Each~     session lasts 30 minutes. Patients are psychometrically assessed weekly for depression~     severity and side effect. After this intervention period patients are followed for further~     three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the~     study period.~   "
169032|NCT01353079|"~     The primary objective of this study is to demonstrate that SLIT administered pre-and~     co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short~     ragweed pollen season.~   "
169033|NCT01353066|"~     Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for~     cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV~     risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial~     intervention in T2DM associated with obesity. Data have shown, that clinical trial aiming at~     the control of CVRF in T2DM may not translate in the reduction of CV events.~      Hypothesis: Intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP)~     could be superior in the control of the progression of subclinical atherosclerotic disease,~     as evaluated by carotid ultrasound, in subjects with T2DM and a BMI between 30.0 and 34.9~     kg/m2.The primary aim of the study is To compare the effects of intensive medical treatment~     (IMM) including Roux-en-Y Gastric Bypass (RYGBP) and IMM alone on the progression of the~     carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to~     baseline.Methodology: Two-year Randomized Clinical Trial, including 240 patients~   "
169034|NCT01353053|"~     The aim of this the study is to the assess whether the graft and patient survival, rejection~     rates and renal graft function after the first year will not differ between both study arms.~     The investigators will also the evaluate the reduction in the incidence of cytomegalovirus~     the and improvement of renal function of the everolimus after 1 year.~   "
169035|NCT01353040|"~     The purpose of this study is to characterize the safety and pharmacology of single~     administrations of AVI-6003, a post-exposure prophylaxis candidate treatment for Marburg~     virus.~   "
169039|NCT01352988|"~     The purpose of this study is to evaluate the therapeutic effect of fumaric acid esters~     (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus with respect to proportion of~     responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI)~     activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest~     assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).~   "
169040|NCT01352975|"~     Background:~        -  Age-related macular degeneration (AMD) is a leading cause of vision loss in individuals~          over 55 years of age. It can cause permanent loss of central vision, which is important~          for seeing fine details and long distances. AMD has two forms: wet AMD and dry AMD. Most~          people with AMD have dry AMD. But dry AMD can progress to wet AMD. Wet AMD is the more~          serious form and can result in severe vision loss.~        -  A method to identify and monitor the early to middle stages of AMD may help researchers~          develop new treatments to stop the disease before it becomes severe. In early dry AMD,~          people cannot see well at night. Researchers want to study whether a procedure that~          measures how the eye adjusts to the dark can help to identify and monitor early to~          middle dry AMD.~      Objectives:~      - To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor~     early to middle dry age-related macular degeneration.~      Eligibility:~      - People at least 50 years of age who have no AMD. Others who have early to middle dry AMD in~     at least one eye.~      Design:~        -  People will be screened with a physical examination, medical history, blood and urine~          tests, and a full eye exam.~        -  This study will last 5 years and require at least 9 visits to NIH. (First visit; study~          visits at months 3, 6, 12, 18, and 24; and 3 yearly followup visits).~        -  Up to 10 people will be asked to come back to the clinic 1 week after their first visit.~          They will be asked to test the device to be used in the study.~        -  Participants will have baseline exams. These questions will be about problems that~          affect their eyes under different lighting conditions.~        -  At every visit, participants will answer questions about general health and current~          medications (including any vitamins or supplements). They will also have a full eye exam~          and a 20- to 40-minute test. This test measures how fast the eyes recover in response to~          decreasing levels of light. The test also measures how sensitive the eyes are to these~          conditions.~        -  Participants will continue to have these tests at the yearly followup examinations. They~          will be treated with the standard of care for any eye conditions they have or may~          develop during the study.~   "
169041|NCT01352962|"~     Background:~      - Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer,~     including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that~     prevents the growth of new blood vessels in tumors, has been approved for treatment of~     certain blood cancers, but it has not yet been approved for use in combination with~     gemcitabine and carboplatin. Researchers are interested in determining the safest and most~     effective dose of this combined form of chemotherapy for solid tumors, particularly for~     urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis).~      Objectives:~        -  To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and~          carboplatin as a treatment for solid tumor cancers.~        -  To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and~          carboplatin as a treatment for urothelial (bladder) cancer.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with solid tumors that have~          not responded to standard treatments.~        -  Individuals at least 18 years of age who have been diagnosed with urothelial cancer that~          has not responded to standard treatments.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          and tumor imaging studies.~        -  Participants with urothelial cancer will receive lenalidomide alone for the first 14~          days of a 21-day cycle before starting the first full treatment cycle.~        -  All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1~          only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the~          first 14 days of each cycle. Participants will be asked to take aspirin or other~          medications to prevent the possibility of blood clots.~        -  Participants may receive up to six cycles of treatment with this combination. If after~          six cycles the cancer has not grown or has shrunk, participants may continue to take~          lenalidomide alone for an additional 6 months (total of 12 months of therapy) or until~          the cancer recurs.~        -  Participants will be monitored with blood samples, physical examinations, and tumor~          imaging studies through the cycles of treatment.~        -  After the end of the last treatment cycle, participants will have followup visits every~          3 months for the next 18 months, then every 6 months for another 18 months, and then~          yearly.~   "
169042|NCT01352949|"~     Background:~      - Stereophotogrammetry (SP) uses four sets of digital cameras to generate a three-dimensional~     computer image. Unlike other types of evaluations which require radiation, SP only uses~     computer images to learn more about physical deformities such as scoliosis or about the~     placement of fat on the body. To refine the SP process, researchers are interested in~     collecting images and body data from individuals with skeletal structural problems such as~     scoliosis or chest wall deformities, individuals who are overweight or obese, and healthy~     volunteers.~      Objectives:~      - To use stereophotogrammetry to study different individual body types and refine existing~     imaging techniques.~      Eligibility:~      - Individuals at least 2 years of age who have spine, rib, or chest wall deformities; are~     overweight or obese (body mass index greater than 25); or are healthy volunteers.~      Design:~        -  Participants will be screened with a physical examination and medical history. The~          physical examination will include measurements of range of motion and joint mobility,~          torso width and length, and other observational data.~        -  Healthy volunteers and participants in the obesity group will also have bioelectric~          spectroscopy (bioimpedance), which uses an additional machine to measure how fat is~          spread in different parts of the body.~        -  After the physical examination has been completed, participants will have SP photographs~          taken. Participants will be asked to remove all clothing from the torso, stand with arms~          raised at the center of four cameras, and remain still while several images are taken. A~          complete image takes less than 1 second.~        -  Participants with spine or rib deformities, or who are in the obesity group, may also~          volunteer to return for followup SP imaging, once a year for 5 years, to study progress~          over time.~   "
169043|NCT01352936|"~     Staphylococcus aureus, the most virulent of the many staphylococcal species, has been~     recognized as one of the most important and lethal human bacterial pathogens. With the~     increased incidence of methicillin-resistant staphylococcus aureus (MRSA) infection in~     community and hospitalized patients, MRSA infections are associated with greater lengths of~     stay, higher mortality, and increased costs. Vancomycin and teicoplanin, are the two most~     commonly used glycopeptides and are the first-choice of treatment for MRSA infection.~     Vancomycin-induced nephrotoxicity is still a point of controversy. Teicoplanin is not known~     to have any nephrotoxicity. Acute kidney injury is a common complication of critical illness,~     which is reported in 5 to 7% of hospitalized patients. It is associated with significantly~     increased mortality, length of stay, and costs across a broad spectrum of conditions.~   "
169044|NCT01352923|"~     In this study PEAR1 polymorphisms effects will be analyze in blood platelets to determine how~     PEAR1 regulates platelet activation.~   "
169045|NCT01352910|"~     Psychogenic paralysis presents a real treatment challenge. Despite psychotherapy,~     physiotherapy, antidepressants, acupuncture or hypnosis, the outcome is not always~     satisfactory with persistent symptoms after long-term follow-up. In a preliminary~     retrospective study on 70 patients with psychogenic paralysis (44F/26M, mean age : 24.7 ±~     16.6 ys), repetitive transcranial magnetic stimulation (rTMS) delivered over the motor cortex~     at low frequency was effective in 89% of cases (recovery: n=53, improvement: n=9), with an~     immediate or quasi-immediate recovery in 73% of patients (n=51).~      We suggest that the dramatic improvement of psychogenic paralysis after rTMS could be due to~     the restoration of an appropriate cerebral connectivity by activating a suppressed motor~     cortex. Nevertheless, the possibility of a placebo effect cannot be ruled out.~      A prospective multicentric (Rouen, Caen) randomized controlled trial versus placebo will be~     done for 94 patients with psychogenic paralysis, 1- to evaluate rTMS efficacy for paralysis~     at short and long term follow-up, and 2- to confirm rTMS safety. Two rTMS sessions will be~     performed at D0 and D1 (120 pulses over 2 days, delivered over the motor cortex at 2 Hz) with~     an active or a sham coil. Post-rTMS assessment will evaluate 1- the degree of the paralysis~     at D2 (quantified by a videotape) and D60 (quantified by an interview and a standardized~     examination), 2- the number and gravity of side effects.~      If psychogenic paralysis improvement by motor cortex rTMS is confirmed, rTMS could be~     considered a useful early therapeutic option.~   "
169046|NCT01352897|"~     The objective of this follow-up retrospective study is to evaluate the long term efficacy and~     safety of rosuvastatin in reducing lipid parameters in clinical practice.~   "
169047|NCT01352884|"~     This is a Phase 1, open-label, multi-center, first time in human study of AMP-224 in adult~     patients with cancer that is not responding to standard therapy. This study will be conducted~     in two stages consisting of a Dose-Escalation stage and an Expansion Stage.~   "
169048|NCT01352871|"~     The innate immune response is the first line of defense against invading pathogens. Ideally,~     the inflammatory response is tightly regulated leading to both adequate protection to~     invading pathogens as well as limitation of an exuberant or unwanted immune response such as~     seen in sepsis or auto-immune diseases. It has become increasingly clear that the autonomic~     nervous system (ANS) and the innate immune response are intimately linked. Activation of the~     sympathetic division of ANS dampens inflammation via β2-adrenoceptors. On the other hand, in~     some cases, sympathetic drive can also stimulate the inflammatory response via~     α2-adrenoceptors. The parasympathetic branch of the ANS modulates the inflammatory response~     as well, since it was discovered that electrical stimulation of the efferent vagus nerve in~     rats greatly inhibits the innate immune response. Generally, the ANS is regarded as pure~     autonomic which can not be influenced by behavior. However, trough special~     concentration/mediation techniques mastered by certain individuals, it might be possible to~     modulate ANS activity. In addition, recent unpublished findings indicate that these~     concentration/meditation techniques can also influence the inflammatory response ex vivo.~      In this study the investigators wish to investigate the effect of concentration/meditation on~     the innate immune response in vivo. In addition the investigators wish to elucidate the~     mechanism via which this effect is mediated. The investigators aim to use the so called human~     endotoxemia model. This model permits elucidation of key players in the immune response to a~     gram negative stimulus in vivo, therefore serving as a useful tool to investigate potential~     novel therapeutic strategies in a standardized setting.~      Objectives:~      Primary objective: The primary objective of the study is to determine the effect of~     concentration/meditation on the innate immune response induced by a lipopolysaccharide (LPS)~     challenge.~      Secondary Objective(s):~        1. To determine the effects of concentration/meditation on ANS activity.~          Electroencephalography (EEG), heart-rate variability (HRV), muscle sympathetic nerve~          activity and plasma concentrations of catecholamines will be measured for this purpose.~        2. To determine if concentration/meditation can attenuate (subclinical) renal damage known~          to occur during human endotoxemia, markers of proximal and distal tubular damage will be~          measured at various time points.~   "
169049|NCT01352858|"~     This is a study which will look at safety, feasibility and acceptability of a new therapy~     called tolerogenic dendritic cells (TolDC), derived from the patient's own white blood cells,~     which will be injected into the knee joints of rheumatoid arthritis patients, using a~     procedure called arthroscopy (a camera examination of a joint). The investigators are also~     looking to see if the drug has any effect on the disease activity (if it can help in RA) and~     whether the drug can affect the immune system. The investigators aim to treat 12 patients in~     total, 9 with TolDC and 3 with a control treatment. Three doses of TolDC will be tested, 3~     patients per dose. Subjects will have RA and at least one swollen knee joint. They will~     undergo a knee ultrasound scan, fill in a series of questionnaires, have their knee aspirated~     (fluid taken out) and finally undergo a procedure called leukapheresis (removal of white~     blood cells) from which the treatment will be manufactured. Subsequently they will undergo 3~     arthroscopies (camera examination of the knee joint) over a period of about 12 weeks. On the~     first arthroscopy they will have the TolDC injected into their knee joint. They will then~     spend the night at the Clinical Research facility for observation. Over the next 5 days they~     will be telephoned daily by the study doctor to check how they are, and will be reassessed if~     needed. About 2 weeks later they will have their second arthroscopy to look for effects of~     treatment, and the third will take place at 13 weeks (end of study) or sooner if the knee~     appears to get worse.~   "
169050|NCT01352845|"~     This study is looking at a new vaccine that might prevent meningococcal disease, and will~     study the immune response elicited by this vaccine when given to healthy young adults. The~     study will also look at the safety of the new vaccine as well as how it is tolerated.~   "
169051|NCT01352832|"~     The investigators propose a two-year group randomized trial of physician practices to test~     the effectiveness of an interactive DVD that presents a culturally appropriate communication~     training program for patients called How To Talk To Your Doctor (and Get Your Doctor to Talk~     to YOU!) in promoting safe prescription and use of Nonsteroidal anti-inflammatory drugs~     (NSAIDs) in the outpatient setting (HTTTYD-NSAIDs).~      The outcome of interest is safer use of NSAIDs as reported by patients. The aims are to:~      Aim 1. Develop an interactive DVD (How To Talk To Your Doctor about NSAIDs, HTTTYD-NSAIDs)~     that presents culturally appropriate stories through which a viewer can learn risk factors~     for adverse effects related to NSAIDs; and communication behaviors for talking about NSAIDs~     with their doctor.~      Aim 2. Conduct a group-randomized trial to test the following three hypotheses about the~     effectiveness of the interactive DVD in promoting safer use of NSAIDs:~      Hypothesis 1: Intervention group patients will be more likely to report that they had a~     conversation with their doctor about safe NSAID use than control group patients.~      Hypothesis 2: Intervention patients will report significantly fewer risky NSAID ingestion~     behaviors (e.g., concomitant use of OTC and prescription NSAIDs) than control patients.~      Hypothesis 3: There will be no difference in the intervention's effectiveness between African~     American and White participants.~   "
169052|NCT01352819|"~     The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an~     adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive~     Parkinson's disease that are not adequately controlled with medication.~      It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation~     system using constant current instead of constant voltage and using a lead with an active~     electrode tip.~   "
169053|NCT01352806|"~     The of epidurals and spinals, relies primarily on palpation of anatomic landmarks that are~     not always easy to find, More so, even after correct identification of palpable landmarks,~     Variability exists leading to performing neuraxial injection in undetermined intralaminar~     level. The most accurate method for identifying the interspace is the using of the~     fluoroscopy or CT technique, but exposure to radiation and availability make it unpractical~     in majority of cases. As ultrasound technology becomes more accessible to the clinician, it~     holds great potential to facilitate performing neuraxial anesthesia by the anesthesiologist~     in routine cases.~      The aim of this study to compare the accuracy of identifying the intervertebral space,~     between manual palpation, versus ultrasound versus fluoroscopy.~   "
169054|NCT01352793|"~     A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to~     receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will~     receive HAVRIX vaccine at month 0 and 6 and saline at month 2.~      All subjects will be followed for 6 months after the last vaccination to assess safety and~     tolerability.~   "
169055|NCT01352780|"~     The aim of this study is to evaluate clinical and health economic parameters in relation to~     individual motivational counseling by phone.~   "
169400|NCT01348256|"~     In this randomized multicentric phase II study, patients with colorectal carcinoma with~     resectable hepatic metastasis will be randomized to treatment with dendritic cells or to~     observation, following conventional treatment with surgery and chemotherapy.~   "
169056|NCT01352767|"~     A randomised, controlled, cross-over study with inpatient and outpatient phases. The~     inpatient phase length will be two days, which include a Control day without activating the~     InSuPad and a Test day where the InsuPad is activated. The outpatient phase length is 8~     weeks: 4 weeks without the device-Control, and 4 weeks with the device-Test.~   "
169057|NCT01352754|"~     Background: Patients undergoing hip fracture surgery are elderly and usually have~     co-morbidities; hence they are at risk for perioperative MI. Troponin is the gold standard~     for diagnosis of myocardial damage and currently the cornerstone of MI diagnosis.~     Perioperative troponin elevation is a poor prognosis factor. The significance of minor~     troponin elevation, detected by highly sensitivity troponin T assay, is unknown.~      Objectives: To determine the frequency of perioperative troponin T elevation using highly~     sensitivity troponin T assay, and to determine the clinical significance of this elevation.~      Methods: Serum Troponin T levels of patients undergoing hip fracture surgery will be tested~     prior to surgery 48 hrs and 72 hrs after surgery, using highly sensitivity troponin T assay.~      Patients will be followed for 1 year. Primary outcomes- The number of patients with elevated~     troponin levels perioperatively and cardiac mortality at 3 months, 6 months and 1 year.~   "
169058|NCT01352741|"~     The main objective of the study is to evaluate the effectiveness, safety, and tolerability of~     increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination~     of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects requiring~     additional analgesia after titration to tapentadol PR 300 mg per day.~      This is a clinical effectiveness trial designed to establish a link between anticipated~     clinical outcomes and the clinical practice by means of selected measures of clinical and~     subject reported outcomes. Since, severe low back pain with a neuropathic component, the~     targeted study population, is frequently treated with a combination therapy (monotherapy is~     often not effective enough) it is of interest to determine if tapentadol alone (combining 2~     mechanisms of action in a single molecule) could be as effective as a combination of~     tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus~     combination are of interest.~   "
169059|NCT01352728|"~     The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving~     transarterial chemoembolization is improved with addition of axitinib.~   "
169060|NCT01352715|"~     The study was conducted on people who were taking their first anti-HIV drug regimen~     (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV~     drug) but the drugs in this regimen were not doing a good job of fighting their HIV~     infection.~      The main purpose of this study was to compare two other anti-HIV drug regimens to see how~     well they fight HIV. The study also looked at how well participants tolerate the drug~     regimens and how safe they are.~      The study was designed to determine whether taking the combination of lopinavir/ritonavir~     (LPV/r) plus raltegravir (RAL) works as well as what is usually used for second-line therapy:~     LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase inhibitor (NRTI)~     combination. Testing a regimen that does not include any NRTIs was important because NRTIs~     may no longer work for patients who received them as part of their first treatment regimen.~   "
169061|NCT01352702|"~     The aim of this study is to evaluate whether dabigatran reduces clopidogrel mediated ADP~     induced platelet aggregation measured by MEA as compared to phenprocoumon after a two-week~     treatment with either agent.~   "
169062|NCT01352689|"~     The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed~     Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.~   "
169063|NCT01352676|"~     Computed tomography (CT) scanning is overused, expensive, and causes cancer. CT scan~     utilization in the U.S. has increased from an estimated 3 million CTs in 1980 to 62 million~     per year in 2007. From 2000 through 2006, Medicare spending on imaging more than doubled to~     $13.8 billion with advanced imaging such as CT scanning largely responsible. CT represents~     only 11% of radiologic examinations but is responsible for two-thirds of the ionizing~     radiation associated with medical imaging in the U.S. Recent estimates suggest that there~     will be 12.5 cancer deaths for every 10,000 CT scans. Renal colic is a common,~     non-life-threatening condition for which CT is overused. As many as 12% of people will have a~     kidney stone in their lifetime, and more than one million per year will present to the~     emergency department (ED). CT is now a first line test for renal colic, and is very accurate.~     However, 98% of kidney stones 5mm or smaller will pass spontaneously, and CT rarely alters~     management. A decision rule is needed to determine which patients with suspected renal colic~     require CT. While the signs and symptoms of renal colic have been shown to be predictable, no~     rule has yet been rigorously derived or validated to guide CT imaging in renal colic. A~     subset of patients with suspected renal colic may have a more serious diagnosis or a kidney~     stone that will require intervention; however the investigators maintain that clinical~     criteria, point of care ultrasound and plain radiography (when appropriate), will provide a~     more comparatively effective and safer approach by appropriately limiting imaging.~   "
169064|NCT01352663|"~     This is an open label, randomized, parallel group comparison of the immunogenicity safety of~     Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics~     patients.~   "
169065|NCT01352650|"~     The hypothesis of this proposal is that combining plerixafor, an inhibitor of stromal cell~     derived factor - 1α (SDF-1α), with decitabine, a DNA methyltransferase inhibitor, as~     induction and postremission therapy for older patients with Acute Myeloid Leukemia (AML) will~     improve treatment outcomes via mobilization of leukemia stem cells and alteration of the~     pharmacodynamics of decitabine. The protocol will establish the safety and feasibility of~     combining two different doses of plerixafor with a fixed dose and schedule of decitabine.~   "
169066|NCT01352637|"~     The purpose of this study is to test the differences between four active treatment conditions~     for combat-related Post Traumatic Stress Disorder (PTSD): virtual reality exposure therapy~     (VRE) or prolonged imaginal exposure therapy (PE), both with DCS or placebo, as well as to~     examine predictors for PTSD and response to treatment in active duty military personnel,~     veterans, and civilians who served in Iraq and Afghanistan.~   "
169116|NCT01351961|"~     In the cross sectional study Adelahyde 1 which took place between 2001 and 2005, the~     investigators data suggest that vascular alterations may play a role in the setting of~     subjective memory complaints.~      This longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the~     evolution of cognitive function and dementia.~   "
169067|NCT01352624|"~     Veterans with psychiatric disabilities face unique challenges concerning money management.~     Financial strain, money mismanagement, and homelessness have been well documented among~     veterans with psychiatric disabilities and linked to poor outcomes. The investigators'~     long-term goal is to promote recovery among veterans with psychiatric disabilities by~     addressing an 'unmet need' of developing basic money skills necessary for independent~     functioning in living, working, and social environments. The investigators' objective in the~     current application is to rigorously evaluate a pilot-tested, stakeholder-informed~     intervention grounded in principles of psychiatric rehabilitation designed to help develop~     money management skills and informed financial judgment among veterans with psychiatric~     disabilities. $teps for Achieving Financial Empowerment ($AFE) is an individualized,~     psycho-educational intervention that aims to teach veterans with psychiatric disabilities how~     to save money, create a viable budget, avoid money scams and financial exploitation, and~     access vocational and mental health resources. To evaluate the $AFE, the investigators will~     randomly assign N=200 veterans with psychiatric disabilities to either (a) the $AFE~     intervention (n=100); or (b) a usual care control (n=100). The investigators will interview~     veterans with psychiatric disabilities at baseline and six months. The investigators' central~     hypothesis, based on strong preliminary data, is that by fostering financial skills and~     judgment, the $AFE will concurrently increase employment, boost work motivation, and reduce~     disablement. If these outcomes are met, the investigators hypothesize the intervention will~     also lead to reduced psychiatric symptoms and homelessness among veterans with psychiatric~     disabilities.~   "
169068|NCT01352611|"~     The purpose of this study is to determine if intrathecal administration of baclofen can~     reduce symptoms of severe tactile defensiveness and autism spectrum disorder.~   "
169069|NCT01352598|"~     This study will evaluate the local control rate as well as acute and late toxicity rates of~     stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.~   "
169070|NCT01352585|"~     This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on~     the treatment response to anagrelide hydrochloride~   "
169071|NCT01352572|"~     The purpose of this study is to determine whether alteration of signal transduction~     components after antidepressant targeting, predict antidepressant responsiveness in advance~     before the appearance of the drug effects until 4~6 weeks after drug administration, or~     represent the clinical status of depressed patients.~   "
169072|NCT01352559|"~     The purpose of this study is to determine whether pharmacogenomic study of bioamine~     transporters and peripheral lymphatic biomarkers(phenotype) predict antidepressant~     responsiveness in advance before the appearance of the drug effects until 4~6 weeks after~     drug administration.~   "
169073|NCT01352546|"~     The use of Botox injections intravaginally and progressive dilation under anesthesia has been~     shown to cure vaginismus. This study expands the use of Botox injections to include~     progressive dilation, post procedure supervised dilation and sex counseling to help women~     transition from dilators to intercourse. Since 2005 patients continue to experience a cure~     rate in excess of 90%. As of December 2012 more than 200 vaginismus patients have been~     treated this way.~      In this completed study of 30 patients with a minimum of one year follow-up 29 vaginismus~     patients were able to advance to pain free intercourse (97%) and one patient failed to~     achieve her goals presumably due to uncontrolled anxiety relating to vaginal penetration.~   "
169074|NCT01352533|"~     The goal of this study is to assess whether wound closure with skin adhesive or running~     stitches combined with skin adhesive will be superior to standard wound sutures. This is a~     split-wound study that will compare two methods of skin closure within one standard closure~     technique, thereby providing an internal control of running stitches within each wound. The~     investigators plan to measure outcomes by assessing for scar appearance, the incidence of~     wound opening, scar elasticity and subject satisfaction.~   "
169075|NCT01352520|"~     The goal of this clinical research study is to learn if SGN-35 (brentuximab vedotin) can help~     to control ALCL, LyP or MF in patients with at least 1 of the 3 skin lymphomas. The safety of~     the study drug will also be studied.~   "
169076|NCT01352507|"~     The primary objective of this study is to evaluate whether, after two 8-week treatment~     periods, male patients with erectile dysfunction (ED) in China prefer 20 milligram (mg)~     tadalafil or 100 mg sildenafil. This trial consists of two treatment periods of 8 weeks each~     and an extension phase of 8 weeks, for a total of 24 weeks.~   "
169077|NCT01352494|"~     The purpose of this study is to assess the response of docetaxel and gemcitabine in the~     neoadjuvant setting in women with locally advanced breast cancer.~   "
169078|NCT01352481|"~     -  The aim of the present study is to examine the effectiveness of a short, highly~          structured parent based speech intervention program on speech development in very~          preterm children with a Speech Sound Disorder (SSD) at 2 years of age.~        -  The hypothesis of this study is that early intervention on speech development is~          effective in improving the speech development in preterm children with SSD at 2 years of~          age compared to a no treatment group (usual care at this age).~   "
169079|NCT01352468|"~     After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only~     two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a~     well-established evidence-base supporting their efficacy for children with ADHD. Both of~     these interventions have inherent limitations. Recently multiple studies have demonstrated~     that cognitive training may improve neuropsychological and behavioral functioning in children~     with ADHD. The magnitude of treatment effects for cognitive training has been comparable to~     treatment effects for behavioral treatment for ADHD (i.e., small to moderate effect sizes). A~     limitation of existing cognitive training programs that may limit their efficacy is that each~     has employed a unifaceted approach. Each intervention program has targeted a single cognitive~     domain (e.g., working memory). This is problematic since as a group, children with ADHD have~     multiple areas of cognitive deficit (i.e., working memory, attention, response inhibition,~     delay aversion, intra-individual variability) and thus a unifaceted intervention does not~     address the multifaceted array of cognitive dysfunction in children with ADHD. Also, because~     individuals with ADHD each have unique patterns of cognitive deficits, a unifaceted cognitive~     training approach may target areas which are non-deficient and miss areas of significant~     deficit in individual patients depending on their ideographic cognitive profile. The primary~     goal of the proposed research is to develop and test a multifaceted cognitive training~     intervention that addresses a comprehensive array of ADHD-related cognitive deficits thereby~     ensuring that children's unique areas of cognitive deficit are targeted. During Phase I (R21~     grant), software and a manual will be developed consisting of four training tasks targeting~     response inhibition, verbal working memory, attention, and delay aversion. Each task will~     possess advancing levels of difficulty. On each task, children will receive feedback on~     performance accuracy as well as on intra-individual variability in reaction times. The~     software will be pilot tested in Phase I to determine performance thresholds and intervention~     duration. Also, focus groups will be conducted to obtain patient perceptions of each task's~     difficulty and interest level. In Phase II (R33 grant), a preliminary randomized clinical~     trial will be conducted in order to obtain initial estimates of treatment efficacy. Pre-,~     post-, and follow up outcomes will be collected on a wide range of neuropsychological,~     behavioral, and academic measures. Effect size estimates across outcomes will be used to~     guide sample size determinations for future clinical trials of multifaceted cognitive~     training.~   "
169080|NCT01352455|"~     A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body.~     Many children with permanent kidney failure undergo dialysis, a life saving procedure that~     takes the place of a kidney. Currently, many children with permanent kidney failure only~     receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on~     dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than~     their healthy counterparts. Survival for these children has not improved over the last 20~     years. These data indicate that the current dialysis treatment strategy is unacceptable.~      This research project will study if more frequent dialysis, performed 5 days per week, will~     improve the health of children with permanent kidney failure compared to the current~     treatment strategy. Children will be treated with both traditional and more frequent dialysis~     schedules to measure improvements in their health and well being.~   "
169081|NCT01352442|"~     The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will~     provide an effective method of for the correction of presbyopia in patients who have normal~     distance vision but need correction such as glasses or contact lenses to see clearly at near.~   "
169082|NCT01352429|"~     This is a study to first establish feasibility of the study and then to register the~     treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer~     presenting for definitive radiation treatment with either proton radiotherapy or Intensity~     Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated~     strategy with our image guided treatment to further improve cancer control and decrease~     toxicity.~   "
169083|NCT01352416|"~     The objective of this study is to show that ranolazine is a safe, viable and potent~     alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac~     surgery~   "
169084|NCT01352403|"~     The purpose of this study is to investigate the effects of gastric bypass in comparison to a~     intensive life style intervention on cardiac function and quality of life in patients with~     morbid obesity.~   "
169085|NCT01352390|"~     The goal of this project is to determine whether prompting the recipient of a health reminder~     mailing to ask his or her 4-9 year-old child to color on the reminder could increase~     engagement with the targeted health behavior~   "
169086|NCT01352377|"~     Assessing the precise MIC for the Ceftriaxone using E-test. To determine what proportion of~     susceptibility reports will be reclassified based on the new CLSI guidelines.Antibiotic~     susceptibility reports of blood cultures, urine cultures,aseptic body fluid cultures growing~     Enterobacteriaceae organism generated by the Phoenix machine will be obtained on a daily~     basis.MIC for Ceftriaxone will be noted.If the MIC is <=2 for Ceftriaxone,those cultures~     would be used to run an additional test - E- test.E-test gives us more precise MIC values~     compared to Phoenix machine.We will analyze the data collected over 2 months. We will~     determine the proportion of susceptibility reports reclassified based on the new CLSI~     guidelines.~   "
169087|NCT01352364|"~     This study aimed to assess and reassess the balance and motor skills of deaf children, passed~     six weeks of intervention and to verify whether a program of physical therapy intervention~     can match or improve motor skills. This study was quasi-experimental before and after, with~     10 children from a school in Caxias do Sul / RS. Motor skills were evaluated using pre and~     post test KTK Coordination Body, and the activities were held once a week for six weeks in~     sessions of forty minutes. It was used for statistical analysis the Student t test dependent~     and independent (p ≤ 0.05).~   "
169088|NCT01352351|"~     The University of North Carolina (UNC) and Partners for Development (PFD), an American~     non-governmental organization, will conduct a 2-year cluster-randomized controlled trial in~     Bauchi State, Nigeria, to test the effectiveness of two behavior change strategies for~     increasing the proportion of participants who exclusively breastfeed their infants until 6~     months. The investigators will build upon PFD's existing microcredit and reproductive health~     program by adding face-to-face breastfeeding education during borrowers' meetings and~     bi-weekly cell phone breastfeeding messages. The hypothesis is that the control group will~     remain at the baseline level for exclusive breastfeeding to 6 months, while the intervention~     group will increase by 15%. The investigators will measure the effectiveness of the~     intervention by conducting baseline and final surveys with a cohort of 485 female borrowers~     who are pregnant at time 1 and who have a 6-month-old infant at time 2. The data will be~     analyzed using logistic regression adjusting for possible confounders and the effect of~     clustering.~   "
169089|NCT01352338|"~     Study Phase: phase 1 and phase 2~      Objective: Evaluation of the effect of lenalidomide, cyclophophamide and prednisone (REP) in~     patients with relapsed multiple myeloma previously treated with lenalidomide~      Study design: prospective, multicenter, non-randomized~   "
169090|NCT01352325|"~     The purpose of this study is to investigate the efficacy of system constellations in a~     monocentric, single-masked randomized controlled trial.~      The method of system constellations refers to an approach which integrates ideas from family~     systems therapy with elements from psychodrama. The constellations are conducted in a group~     based seminar-setting, each seminar lasting three days.~      Based on the model of a general psychotherapy and the consistency theory, the effects of~     system constellations on psychological functioning are explored.~      It is predicted that participation in a system constellation seminar changes the level of~     psychological functioning at 4 months.~   "
169091|NCT01352312|"~     This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab~     (PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell~     Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal~     dose of bendamustine in combination with pentostatin and ofatumumab, and then to see how safe~     these three drugs work together.~   "
169115|NCT01351974|"~     Axillary lymph node dissection (ALND) was previously the standard axillary staging procedure~     in breast cancer patients. However, ALND is accompanied by a considerable morbidity, and~     sentinel lymph node biopsy (SLNB) evolved as a mean to decrease this morbidity. Between~     September 2000 and January 2004 breast cancer patients were included in the Swedish Sentinel~     Node Multicenter Cohort Study with the intent of studying axillary recurrence after negative~     SLNB for patients in which completion ALND were omitted. The patients were followed~     prospectively and events (local, regional and distant recurrences and deaths) were~     registered. The primary endpoint was axillary recurrence and secondary endpoints were~     disease-free, cancer-specific and overall survival.~   "
169092|NCT01352299|"~     Orotracheal intubation the commonest method used to secure and maintain airway during~     anaesthesia. A variety of methods are available for orotracheal intubation such as digital or~     tactile method, use of lighted orotracheal intubating stylet, use of intubating LMA (which is~     becoming increasing popular, particularly in cased of anticipated difficult intubation),~     fibreoptic endoscopic orotracheal intubation (also used when a difficulty is predicted), and~     conventional and most common method, direct laryngoscopy. Orotracheal intubation is most~     commonly achieved after visualization of laryngeal inlet with direct laryngoscopy following~     induction of general anaesthesia and muscle relaxation achieved by administration of a muscle~     relaxant.~      Due to the hazards seen with failed intubation, anaesthetists are also on the lookout for~     techniques which will improve visualization of the laryngeal inlet, i.e. glottis. View~     obtained during laryngoscopy can be classified in a variety of ways such as Cormack Lehane~     grading, the percentage of glottic opening (POGO Score)Literature suggests that straight~     blade gives better glottic visualization while tracheal intubation is easier with the curved~     blade. We therefore wanted to compare the Macintosh and Miller laryngoscope blades in terms~     of visualization of Laryngeal inlet and ease of intubation in patients with normal predicted~     intubation. We also compared the McCoy blade, a modified curved blade, and the Trueview~     Laryngoscope, which incorporates a prism in a straight blade, for glottic view and ease of~     intubation.~   "
169093|NCT01352286|"~     The purpose of this study is to 1) evaluate the safety and tolerability of autologous~     genetically modified T cells transduced to express the high affinity NY-ESO-1c259 TCR in~     HLA-A2+ subjects and 2) measure the incidence of GVHD in patients following infusion of TCR~     modified autologous T cells.~   "
169094|NCT01352273|"~     This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two~     stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and~     tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part~     to further assess the safety and preliminary anti-tumor efficacy of this oral combination~     within two separate patient populations: i) patients with advanced solid tumors harboring~     BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations.~   "
169095|NCT01352260|"~     The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients~     undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System,~     Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to~     determine which modality best correlates with jugular venous oxygen saturation~   "
169096|NCT01352247|"~     In the majority of patients with osteoarthritis of the knee the disease originates in the~     medial compartment. There are two different approaches to replacing this arthritic area. Some~     surgeons feel that it is always best to replace both the knee compartments with a Total Knee~     Replacement (TKR). Others feel it is best to replace just the damaged component of the knee~     with a Unicompartmental Knee Replacement (UKR). There is little agreement amongst knee~     surgeons. Both interventions are established and well documented procedures, yet little~     evidence exists to support either practice. Each intervention is considered standard care.~     There exists little evidence, however, to prove the clinical and cost effectiveness of either~     management option.~      The aim of the Total or Partial Knee Arthroplasty Trial (TOPKAT) will be to assess the~     clinical and cost effectiveness of Total Knee Replacements versus Unicompartmental Knee~     Replacements in patients with medial osteoarthritis. This will be examined using an~     appropriate patient base and long term assessments.~      The trial has a combined device/expertise based allocation depending on the local situation.~     Surgeons who are in equipoise and have sufficient experience to perform both TKR and UKR,~     randomisation and allocation can be based on device (UKR or TKR). The same surgeon will~     perform the operation for both arms of the study.~      For surgeons who hold a preference for one treatment over the other, an expertise based~     randomisation will then occur. UKR surgeons will work alongside TKR surgeons. Patients~     recruited to the study from these sites will be randomised to one of the treatment options~     and treated by the appropriate surgeon. In such cases the patient is internally referred to~     the other surgeon's operating list.~      Patients will be recruited by their consultant knee surgeons in collaboration with the local~     research team. TOPKAT are hoping to recruit 500 patients altogether, with 250 per arm of the~     trial.~   "
169097|NCT01352234|"~     Placental insufficiency is the source of preeclampsia (PE) and intrauterine growth~     retardation (IUGR). Current data demonstrate a significant beneficial effect of prophylactic~     use of aspirin on the recurrence of placental insufficiency and its complications, mainly~     preeclampsia, when started early in pregnancy. However, there is a significant heterogeneity~     in medical practice in Canada and around the world in terms of the dose of aspirin used.~      The objectives of this study are: 1) Evaluate whether a dose of 160 mg of aspirin is~     associated with greater improvement in placental function assessed by biochemistry (sFlt-1~     and endoglin) and ultrasound (uterine artery Doppler) than a dose of 80 mg in women with a~     history of PE, 2) Assess whether the change is dependent on platelet aggregation measured by~     a test used in several Canadian centers (PFA-100).~   "
169098|NCT01352221|"~     The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation,~     is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with~     non-active Crohn's Disease (CD).~   "
169099|NCT01352208|"~     The study has three parts. Part 1 is a dose escalation to investigate the safety and~     tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial~     anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.~   "
169100|NCT01352195|"~     The primary purpose of this study is smoking cessation. The investigators are conducting a~     research study to learn how well the information from the program helps participants to quit~     smoking and remain smoke-free.~   "
169101|NCT01352182|"~     The purpose of this study is to evaluate the pharmacokinetics of pioglitazone and to~     determine the effect on inflammatory biomarkers for pioglitazone in patients with severe~     sepsis and septic shock.~   "
169102|NCT01352143|"~     The primary goal of this investigation is to determine the ability of recombinant activated~     factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to improve thrombin generation~     in neonatal plasma after CPB.~   "
169103|NCT01352130|"~     Postoperative nausea and vomiting [PONV] are common and distressing symptoms after surgery~     performed under general anaesthesia. 5HT3 antagonists are routinely used for prevention as~     well as treatment of PONV. After IRB approval we compared the effects of ondansetron and~     granisetron on the various intervals on ECG in 70 patients undergoing elective surgery for~     carcinoma breast after written informed consent. The demographic data was collected. The~     administration of the anaesthetic was left to the discretion of the operating room staff~     specialist. In the Postoperative Recovery Room patients were randomised to receive 8 mgs of~     ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at 0 mins (before~     injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours. Pulse rate,~     Non-invasive blood pressure and SpO2 were also recorded. T~   "
169104|NCT01352117|"~     AIDS-related Kaposi's sarcoma (AIDS-KS) occurs in persons with HIV infection who are also~     infected with the Kaposi's sarcoma herpesvirus (KSHV). Several chemotherapy (anti-cancer)~     drugs work well in treating KS, but there is no treatment that cures KSHV infection. One~     chemotherapy drug called etoposide (VePesid®, ET) has caused KS tumors to get smaller in some~     people.~      Antiretroviral therapy (anti-HIV drugs or ART) is a group of medicines taken together to~     treat HIV infection. These medicines help to stop HIV from growing in the body. When this~     happens, the immune system, which fights infection and some cancers like KS, gets stronger.~     For some people, limited stage KS often improves or stays the same when they take ART.~     However, in some people KS continues to get worse when taking ART. These people may need~     chemotherapy at a later date.~      This study was done to find out if taking ART with immediate etoposide (ET) is better than~     taking ART alone or ART with delayed ET to treat limited stage KS. The study also tried to~     better understand KSHV and to see what kind of side effects are caused by ART and ET and how~     safe ART and ET are.~   "
169105|NCT01352104|"~     Investigating effectiveness of the cognitive-behavioral based teacher training under routine~     care conditions by comparison of a baseline-interval with no special intervention to a~     following interval of PEP for the kindergarten teachers only each focussing on one child (3-6~     years old) that the teacher herself indicated as needing special attention for externalising~     behaviour. Effects on child symptoms and teachers behavior and burden within~     intervention-period are expected to be stronger than those during waiting-period.~   "
169106|NCT01352091|"~     The present study is a randomized open-label -phase III study that aims to compare the~     efficacy of Zoladex® combined with Aromidex® for 3-2 years after SERMs (tamoxifen and~     Fareston®) as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years~     for premenopausal breast cancer women with hormone receptor positive, lymph node positive or~     tumor ≥4cm. According to St. Gallen's guideline, hormone receptor positive was defined as~     endocrine responsive and endocrine response uncertain categories (table 3-1), and only those~     with ER or PR expression undetectable were considered as HR negative. The pathological~     evaluation of axillary lymph node could be done by sentinel node biopsy (SNB) when axillary~     nodes were clinically impalpable accompanied with axillary lymph node dissection (ALND) or~     directly through ALND when axillary nodes appeared to be positive in clinical examination.~     Based on the operating standard of local medical institution, identifying the numbers of~     lymph nodes to do the pathological evaluation and to do the dissection of I- or II-station~     nodes accurately.~   "
169107|NCT01352078|"~     The purpose of the WE-HEAL Study is to help researchers use human tissue samples and health~     records to study the reasons why some patients heal quickly and some have problems healing~     wounds. All patients seen with an open wound or hidradenitis suppurativa are invited to~     participate. Information from this research may help to understand how to prevent and treat~     certain diseases.~   "
169108|NCT01352065|"~     Endothelin receptors antagonists (ERA), such as bosentan and ambrisentan, are a class of~     vasoactive drugs that have been developed for the treatment of pulmonary arterial~     hypertension. It has been anecdotally reported that ERA is frequently used among top-level~     athletes to counteract exercise-induced rise in pulmonary vascular pressures and increase~     exercise performance. Yet, the effects of ERA on exercise capacity in healthy humans are~     puzzling, with the drugs not included in the current Prohibited List, since the ergogenic~     potential is yet to be fully understood and determined. Furthermore, the urinary excretion of~     ERA metabolites following administration has not been studied systematically at rest and~     during exercise in athletes, as a way to detect its intake if performance-enhancing potential~     is confirmed. In the planned study ERA will be administered in newly approved doses for 8~     weeks in order to assess the presumed doping potential for both male and female athletes, and~     to monitor serum and urinary ERA excretion dynamics after single- and multiple-dose~     administration. The possible effects of prolonged ERA administration in higher doses on~     exercise performance may be relevant, if further confirmed, in terms of their possible~     fraudulent utilization to influence exercise performance in sports, raising the difficult~     question of whether, particularly in some circumstances, the ERA might be considered as~     prohibited substances in athletes.~   "
169109|NCT01352052|"~     The primary objective of the current study is to evaluate the outcome of an interdisciplinary~     multi-component rehabilitation programme customized to patients with chronic widespread pain~     (CWP) based on multidimensional diagnostic assessment including sub-grouping, and aiming to~     improve functional ability in everyday life. The hypothesis is that a patient-focused~     multi-disciplinary rehabilitation approach will improve both functional ability and quality~     of life for patients with CWP.~   "
169110|NCT01352039|"~     The primary objective and endpoints of the study is compare the efficacy of two products~     containing heparin sodium, evaluating if the formulation produced by Eurofarma can be~     considered non-inferior to the reference product.~   "
169111|NCT01352026|"~     Treatment of PAH includes exercise limitation, non specific agents (anticoagulants, diuretics~     and supplemental oxygen), pulmonary specific vasodilators and antiproliferative agents.~      Recent data obtained by our group, within rat PAH models, showed that the antihyperglycemic~     drug metformin, used in France since 1959 in diabetic type II patients, significantly acts at~     the pulmonary arteries level.~      According to these results, and knowing that metformin is a widely used drug, with a~     favorable safety profile, the investigators decided to set up a pilot study, in order to~     evaluate the activity of metformin in PAH treatment. In parallel, the investigators will~     focus on metformin mechanism of action.~   "
169112|NCT01352013|"~     The purpose of this study is to find out if omega-3 fatty acid supplements are more effective~     than an inactive placebo at reducing pain, reducing fatigue and elevating mood in patients~     with fibromyalgia.~   "
169113|NCT01352000|"~     The study primary purpose is smoking relapse prevention. This study is a collaboration~     between researchers who developed the relapse-prevention intervention, at the H. Lee Moffitt~     Cancer Center in Tampa, Florida, and those associated with the New York State Smokers'~     Quitline (NYSSQL), at Roswell Park Cancer Institute in Buffalo, New York.~   "
169114|NCT01351987|"~     To analyze the change in International Prostate Symptom Score (IPSS) and serum~     prostate-specific antigen (PSA) level from baseline.~   "
169860|NCT01342224|"~     This study will add an immunotherapy component to chemotherapy and radiation treatment in~     patients who have pancreatic cancer. The objective of this study is to see if the combined~     treatment is safe and feasible, and if a larger study is warranted.~   "
169117|NCT01351948|"~     This study aims to compare the safety and immunogenicity of AdCh63 AMA1 and MVA AMA1vaccine~     candidates administered alone and with adjuvants in various schedules. These vaccines consist~     of inactivated viruses which have been modified, so they cannot reproduce in humans, and also~     to include genetic material for malaria protein AMA1 which is expressed by the malaria~     parasite during blood stage infection. The vaccines are designed to stimulate an immune~     response to this malaria protein and thus provide protection against malaria infection.~     Adjuvants are a crucial component of modern vaccine regimens, increasing the immunogenicity~     and potency of protein vaccines. In this study we will assess whether virus vectored vaccines~     combined with protein in adjuvant AMA1-C1/Alhydrogel® and CPG 7909 adjuvant (emulsion~     containing TLR agonist) can induce stronger and more durable immune response.~   "
169118|NCT01351935|"~     The purpose of this study is to evaluate the safety and tolerability of AVL-292 as~     monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL),~     chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).~   "
169119|NCT01351922|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     current status of diabetes management, control, and complications in diabetic subjects in~     India. Perceptions and practices of physicians and subjects about diabetes management will~     also be evaluated.~   "
169120|NCT01351909|"~     This phase I trial studies the side effects and best dose of cyclophosphamide and veliparib~     when given together in treating patients with breast cancer that has spread from where it~     started to nearby tissue or lymph nodes or to other places in the body. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving cyclophosphamide together with veliparib may work better in~     treating breast cancer.~   "
169121|NCT01351896|"~     This randomized phase II trial studies how well giving lenalidomide together with vaccine~     therapy works in treating patients with early-stage asymptomatic chronic lymphocytic leukemia~     or small lymphocytic lymphoma. Lenalidomide may stop the growth of cancer cells by blocking~     blood flow to the cancer. It may also stimulate the immune system in different ways and stop~     cancer cells from growing. Vaccines may help the body build an effective immune response to~     kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger~     immune response and kill more cancer cells.~   "
169122|NCT01351883|"~     Perioperative usage of immunonutrition (ANOM®) can attenuate the pro-inflammatory cytokines~     and reduce postoperative infectious complications and length of hospital stay after major~     upper gastrointestinal surgery.~      (ANOM®)immunonutrition product name~   "
169123|NCT01351870|"~     This is an international prospective randomised trial, which will compare two radiotherapy~     regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully~     staged 'standard risk' medulloblastoma.~   "
169124|NCT01351857|"~     Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D)~     improves diabetes clinic attendance as well as glycemic control after transition from~     pediatric to adult diabetes care.~   "
169125|NCT01351844|"~     Patients have been asked to participate in the CEASE study because their treating oncologist~     has recommended that they start an aromatase inhibitor medication. These medications are~     associated with joint complaints. The purpose of this study is to see whether a~     computer-based educational module is a feasible intervention to help address these symptoms.~     If the patients agree to participate, a research coordinator will test their grip strength~     and give them a computer log-on code. They will be shown how to log-on to complete the~     educational module and a few simple questionnaires. Patients have the option to do this from~     home if they wish. In 3 months time, the investigators will ask patients to return to the~     clinic and have another grip strength evaluation and complete some additional questionnaires.~     The computer module and the follow up visit will each take about 30 minutes of time.~   "
169126|NCT01351831|"~     Background and purpose:~      In the early phase after a total knee replacement (TKA), patients experience a decrease in~     leg muscle strength with up to about 80%. This considerable loss of muscle strength is~     related to reduced functional performance at this point in time. As the loss of muscle~     strength and functional performance is most pronounced early after TKA, rehabilitation~     including strength training initiated early after TKA seems a logical choice. However,~     tradition and fear of symptom exacerbation, such as increased knee joint swelling, knee pain~     and slow recovery of knee joint range of motion, have typically precluded strength training~     early after TKA.~      Hypothesis:~      Our hypothesis is that the effect of early rehabilitation including strength training will be~     greater than rehabilitation without strength training. If the hypothesis is confirmed,~     strength training early after TKA could be implemented directly into clinical rehabilitation~     practice.~      Participants and methods:~      Seventy participants with a unilateral TKA, between the age of 18 to 80 years, who understand~     and speak Danish, have given informed consent, will be included in this study.The study is a~     single-blinded randomized controlled study, where the participants receive supervised 1)~     rehabilitation with or 2) rehabilitation without strength training in 7 weeks. All components~     of the rehabilitation program (balance-, and mobility training etc.) are the same in both~     groups except the strength training exercises. Instead of the strength training exercises,~     the group without strength training spend more time on warm-up exercises, mobility- and~     balance exercises. The rehabilitation program lasts 1 hour per session, and will be performed~     twice per week. The participants perform a test battery 4 times from before to 6 months after~     the TKA. The test battery assesses the participants' walking ability, leg strength, knee~     pain, knee joint swelling- and range of motion, and self-reported function and quality of~     life.~      Ethical issues:~      From a pilot study conducted in the beginning of 2010, the investigators found, that strength~     training initiated early after TKA seems feasible, and does not increase knee joint swelling~     and knee pain. None of the financial supporters, or any of the authors, have any potential~     conflicts of interest with regard to the study.~   "
169127|NCT01351818|"~     To assess the influence of exogenous GH (growth hormone) administration on adipocyte~     endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children~     with delayed growth due to GH deficiency.~      Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and~     ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a~     regulatory effect on such hormones.~   "
169135|NCT01351714|"~     When performing a resection of the right colon due to cancer one aims not only to remove the~     tumor bearing bowel segment, but also lymph nodes draining the affected area. These lymph~     nodes are located along the arteries supplying the right colon. Through using a preoperative~     CT scan which can map these arteries very precisely one can ligate these vessels closer to~     their origin and thus remove more lymph nodes which may potentially harbor cancer cells. This~     study aims to compare patients operated more radically through use of preoperative CT which~     maps the mentioned arteries with patients operated in the standard way.~   "
169861|NCT01342211|"~     This study will investigate the effect of PF-04950615, a new investigational lipid lowering~     agent, on LDL-C and other lipids.~   "
169128|NCT01351805|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     25,876 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among VITAL participants and will examine~     whether vitamin D or fish oil have effects upon A) autoimmune disease incidence, B)~     biomarkers of systemic inflammation, and C) chronic knee pain. Blood samples at baseline and~     in follow-up will be collected in a randomly selected subcohort of 2000 individuals and~     analyzed for changes in biomarkers of systemic inflammation: C-reactive protein,~     interleukin-6, and tumor necrosis factor-receptor 2. Approximately 2000 individuals with~     chronic, frequent knee pain will be followed with annual questionnaires to evaluate the~     effects of the supplements on chronic knee pain.~   "
169129|NCT01351792|"~     The purpose of the present study is to demonstrate the higher efficacy of small particles~     Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations~     b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic~     Obstructive Pulmonary Disease (COPD) patients.~   "
169130|NCT01351779|"~     Glaucoma is a condition where the optic nerve (the nerve responsible for sight) shows~     progressive damage with characteristic loss of visual field. Glaucoma is very commonly~     associated with raised pressure in the eye (intraocular pressure [IOP]). IOP has been shown~     to increase when lying down in normal subjects as well as patients with glaucoma. It is~     possible that this effect can make glaucoma worse. This study is designed to investigate the~     effect of body posture (particularly when sleeping) on the IOP fluctuation in the eye. Each~     patient will be required to attend for 2 separate 24 hour visits. On one visit the patient~     will be required to sleep flat and on the other visit at a 30° head up sleeping position.~     During this time the patient will be required to wear a soft contact lens (SENSIMED~     Triggerfish®) which has a special sensor on it that monitors the IOP continuously. The IOP~     measurements are wirelessly transmitted to a recorder.~   "
169131|NCT01351766|"~     Evidence suggests a significant percentage of adolescent regular smokers are interested in~     trying to quit smoking and frequently make attempts to quit, yet are unsuccessful in~     maintaining abstinence on their own. Despite a genuine desire to quit on the part of many~     adolescents, there is an increasing incidence of smoking among older adolescents that runs~     counter to the overall trends of smoking reduction seen in the general population.~     Unfortunately, psychosocial and pharmacological smoking interventions have yet to indicate~     clear effectiveness with youth. Moreover, depression-related vulnerabilities, particularly~     currently elevated depressive symptoms, are highly comorbid with smoking behavior and~     dramatically reduce cessation rates. As a result, new approaches to smoking cessation are~     needed for adolescent smokers with currently elevated depressive symptoms. Thus the objective~     of the present study is to develop a specialized behavioral activation treatment for smoking~     in youths ages 18-21 with elevated depressive symptoms. In the first phase we utilize focus~     groups and pilot testing with 15 youths to develop the behavioral activation smoking~     treatment for youth (BATSY). In Phase II, we will conduct an open-label trial of BATSY plus~     nicotine replacement therapy with 30 youths who will also take part in a neuroimaging~     protocol examining reward sensitivity. Participants will be followed over 26 weeks post-quit~     date.~   "
169132|NCT01351753|"~     Obesity is common (>30% of US adults), contributes to substantial morbidity and mortality,~     but is difficult to treat. Partly this is due to the transient, arduous and modest nature of~     lifestyle interventions. Partly it is due to the limited efficacy and safety problems of~     existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity;~     but its effects on weight are relatively small. There are drugs that have been approved for~     other diseases but which also reduce weight. One promising approach to treating obesity is~     combination therapy with orlistat and one or more of these other agents. The investigators~     propose an innovative approach to developing new therapies for obesity coupling the use of~     combination therapy with rigorous assessment of cardiovascular safety. Vascular function is a~     quantitative surrogate clinical endpoint that has been strongly and independently linked to~     future cardiovascular events.~      Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular~     function in obese human subjects. The co-primary endpoints will be weight and vascular~     function.~   "
169133|NCT01351740|"~     A drug-drug interaction between the anti-HIV drugs tenofovir DF (TDF) and atazanavir (ATZ)~     results in lower ATZ plasma levels when the drugs are given together, particularly in~     patients not taking ritonavir to boost ATZ levels. Lower plasma drug levels may make the~     anti-HIV regimen less effective in controlling the HIV virus levels in the blood. For this~     reason, current treatment guidelines recommend that ATZ always be boosted with ritonavir in~     regimens also containing TDF. However, withdrawal of ritonavir is often desirable given the~     tolerability and toxicity issues with this agent, even at the low dose (100 mg daily) used to~     boost ATZ. For example, ritonavir can cause stomach upset, nausea, diarrhea, high cholesterol~     levels, and liver enzyme abnormalities.~      However, there is evidence that plasma ATZ levels may not predict treatment success on~     unboosted ATZ regimens, particularly among people whose plasma HIV virus is already under~     control and unboosted ATZ is being used as a maintenance strategy. In the BC Centre for~     Excellence in HIV/AIDS Drug Treatment Program (DTP), nearly 100 patients originally treated~     with ritonavir-boosted ATZ + TDF (+ FTC or 3TC) are receiving successful maintenance therapy~     with unboosted ATZ and the same TDF-based backbone.~      The study will examine the hypothesis that switching to maintenance therapy with unboosted~     ATZ 400mg daily will have similar 48-week virologic efficacy to continuing ATZ/ritonavir~     300/100mg daily among HIV-infected adults with stable viral load suppression on regimens~     comprising ATZ/ritonavir 300/100mg daily with TDF plus either FTC or 3TC, despite potentially~     lower ATZ trough levels with the unboosted regimen. In other words, patients whose HIV viral~     load is undetectable while receiving TDF (+FTC or 3TC) and ATZ/ritonavir will continue to~     maintain an undetectable viral load after switching to unboosted ATZ without ritonavir, in~     the same proportions as those continuing on their boosted ATZ/ritonavir regimen.~   "
169134|NCT01351727|"~     The purpose of this proposed research is to identify individuals in southeastern Arizona aged~     65 years and older who have new onset seizures (or newly diagnosed epilepsy) and monitor them~     for at least two years. In doing so the investigators will be able to describe the public~     health burden of this condition and to identify factors that predict clinical outcomes and~     health care needs in this population, using quantitative, administrative, and qualitative~     data. The aims of this proposed research are 1) to determine the two-year incidence of newly~     diagnosed epilepsy in the target population, 2) describe health care resource utilization of~     the target population using Medicare data, 3) validate the use of Medicare beneficiary data~     to estimate incidence of epilepsy, and 4) describe the burden of this condition in different~     ethnic groups.~   "
169879|NCT01341977|"~     The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone~     hydrogel and soft hydrogel contact lens wearers.~   "
169136|NCT01351701|"~     The pattern of organism causing diabetic foot infection are presumed to vary from location to~     location depending on the antibiotic prescription practice, geographical locations,~     environmental variations and therapeutic interventions for various patients. Our hypothesis~     is look to finding out common similarities with diversified subgroups spread across various~     geographical locations of eastern part of India, thus to create a data base for treating~     patient with diabetic foot infections.The sensitivity pattern is anticipated to be different~     from institution to institutions and place to place but the gross sensitivity data of local~     pathogen could guide physician for choosing right empirical antibiotic. Practice guideline~     could be postulated from the collated data of distribution of pathogens, their sensitivity~     pattern as well as co-morbid conditions of the sufferers.~   "
169137|NCT01351688|"~     The primary aim of study is to gain an initial assessment of safety and tolerability of~     AZD3514 in Japanese patients together with assessing Pharmacokinetics (PK) and gaining a~     preliminary assessment of anti-tumour action. In this study, AZD3514 will be administered to~     Japanese patients with metastatic castration resistant prostate cancer.~   "
169138|NCT01351675|"~     This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying~     progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with~     Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.~   "
169139|NCT01351662|"~     Linking a psychosocial stress intervention with clinical measures of stress in African~     American lupus patients will assess the utility of this method in reducing perceived stress,~     and provide the necessary preliminary steps toward future investigations of potential~     mechanisms.~   "
169140|NCT01351649|"~     Specific aims are:~        1. Evaluate the feasibility of the intervention related to (1) girls' participation; (2)~          adherence to protocols; and (3) user and provider (nurse and PA Club instructors)~          satisfaction.~        2. Explore if participants in the intervention group, compared to those in the control~          group, show improvement in the primary outcome of minutes of moderate to vigorous~          physical activity (MVPA; measured by accelerometer), and also secondary outcomes of~          self-report of MVPA, cardiovascular fitness, body mass index, percent body fat, and~          waist circumference at 6 months.~        3. Explore if the primary outcome is mediated by cognitive (perceived benefits of PA,~          perceived barriers to PA,PA self-efficacy, social support, norms, models) and affective~          (enjoyment of PA) variables.~        4. Explore if participants in the intervention group, compared to those in the control~          group, have greater minutes of MVPA at 7 months.~   "
169141|NCT01351636|"~     The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality~     and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.~   "
169142|NCT01351623|"~     The purpose of this study is to test a new drug called carfilzomib. It is a type of drug~     called a proteasome inhibitor. Proteasome breaks down proteins that are no longer useful to~     the cell. When the proteasome is turned off by a drug (like carfilzomib), useless proteins~     cannot be broken down. Instead the proteins build up and cause the cell to die. Myeloma cells~     make a lot of protein and are especially in need of a functional proteasome to survive.~      Carfilzomib is not approved for use by the Food and Drug Administration to treat myeloma. It~     is considered an experimental drug. Previous studies have shown that carfilzomib is safe to~     use. This study will look at what the effects, good and/or bad, carfilzomib has on myeloma.~   "
169143|NCT01351610|"~     MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow~     derived stem cells for the treatment of Critical Limb Ischemia~   "
169144|NCT01351597|"~     The purpose of this study is to evaluate the overall response rate, toxicity, progression~     free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent~     or metastatic breast cancer.~   "
169145|NCT01351584|"~     The registry aims to collect and analyse information on the antineoplastic treatment of~     breast cancer in daily routine practice of office-based and clinic-based medical oncologists~     in Germany.~   "
169146|NCT01351571|"~     This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in~     combination with interferon alpha-2a as first-line treatment in patients with advanced and/or~     metastatic renal cell carcinoma. Data will be collected from each patient as per routine~     clinical practice of the Investigator (maximum of 52 weeks, until disease progression~     /unacceptable toxicity or withdrawal of consent) and/or based on the local label.~   "
169147|NCT01351558|"~     There is ample evidence that exercise therapy is beneficial with respect to pain in patients~     with osteoarthritis of the knee. However, the pain relieving mechanisms are unknown. To~     enhance the efficacy of exercise therapy a deeper understanding of the involved mechanisms is~     needed.~      Different exercise types may affect the pain sensitivity differently. It is hypothesized that~     non-specific exercises (i.e. exercises that does not involve the knee) reduces the processing~     of pain in the central nervous system (central sensitivity) to knee joint pain in healthy~     subjects. It is also hypothesized that exercises that involve the knee (i.e. specific knee~     exercises) reduce the sensitivity of pain receptors in the knee (peripheral sensitivity) in~     healthy subjects.~      Healthy volunteers are recruited and randomised to one of four interventions: 1: Muscle~     strengthening exercises involving the thigh muscles; 2: Muscle strengthening exercises~     involving the shoulder muscles; 3: Cardio-vascular fitness exercises; or 4: Control (no~     exercises). The active interventions include exercises three times per week for 12 weeks.~     Pain sensitivity and a range of explanatory variables is measured before the interventions,~     after 4 weeks and after 12 weeks.~   "
169148|NCT01351545|"~     This study is an access and distribution protocol for unlicensed cryopreserved cord blood~     units (CBUs) in pediatric and adult patients with hematologic malignancies and other~     indications.~   "
169149|NCT01351532|"~     The purpose of this research is to apply this smoking cessation program on oral cancer~     patients, and to analyze the effectiveness of it.~   "
169212|NCT01350713|"~     Skin burns are one of the causes of disability, suffering and death in humans. Anecdotal,~     uncontrolled studies have shown the efficacy of povidone-iodine ointment in human skin burns,~     provided the preparation was applied shortly after the exposure to the heat source. The~     proposed study will conduct a controlled study in which the effect of povidone-iodine~     ointment will be tested in large group of patients and will be compared with standard cold~     water treatment.~   "
169150|NCT01351519|"~     In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA)~     prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor~     tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light~     in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink~     allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The~     aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue~     improves the surgeon's ability to completely resect or remove the brain tumor.~   "
169151|NCT01351506|"~     Aims of study~        1. Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in~          28 days~        2. Determination cut point of maximum weight change to outcome treatment~   "
169152|NCT01351493|"~     The purpose of this study is to evaluate the efficacy of nitric oxide gel for pressure sore~     recovery.~   "
169153|NCT01351480|"~     The purpose of this study is to determine if the use of sub-cutaneous (SC) abatacept provides~     any structural benefit in patients with rheumatoid arthritis who have failed prior use of TNF~     therapy.~   "
169154|NCT01351467|"~     The purpose of this study is to examine how genes and environment affect risk for Parkinson's~     disease.~   "
169155|NCT01351454|"~     The objective of the current study is to test a novel, behavioral approach to treat~     depressive symptoms and improve HIV medication adherence and subsequent physical health~     outcomes among African American HIV-infected substance users residing in inner-city~     Washington, DC. This treatment will serve as a compliment to standard residential and~     follow-up outpatient substance use treatment, with the goal of reducing depressive symptoms~     and improving HIV medication adherence, physical health, and substance use outcomes.~   "
169156|NCT01351441|"~     It has been shown that patients can improve their safety through informed choice, safe~     medication use, and complication reporting. This includes not only the potential problems~     that occur from prescription medication use but also issues that may arise through the~     improper use of over-the-counter medications. The willingness of a patient to take on safety~     action is known to be complicated by an unwillingness to behave in a manner that might~     challenge a physician's judgment or actions. Community pharmacists are in the unique position~     to provide perspective on the physician's recommendation and act as an advocate to facilitate~     necessary change. Through supportive and repeated interaction with their community pharmacist~     patients will develop assertiveness toward their own health care, an increased frequency and~     quality of interaction with their physician, and thus a minimized risk of harm and maximized~     opportunity to optimize clinical outcomes.~   "
169157|NCT01351428|"~     Preeclampsia is associated with significant maternal and fetal morbidity and mortality. Early~     identification and subsequent management of patients at risk of developing preeclampsia~     presents an ongoing challenge in prenatal care. Some at risk pregnancies may be identified~     from:~        -  serum screening abnormalities in the first or second trimester~        -  placental shape and texture at the 18-20 anatomical ultrasound~        -  uterine artery blood flow.~      Early identification and effective treatment of patients would permit the safe completion of~     the pregnancy for the mother and infant. Recent advances in non-invasive cardiovascular~     monitoring have enabled the study of maternal hemodynamics in normal and at-risk pregnancies.~     This study hopes to identify the earliest significant changes in maternal hemodynamics which~     may allow targeted therapeutic interventions in patients at high risk of developing~     preeclampsia.~      The hypothesis of this study is that systemic vascular resistance rises during the~     pre-clinical phase of preeclampsia and this can be captured using non invasive bioreactance~     technology. Treatment of the abnormally high vascular tone may decrease the severity and~     postpone the onset of clinical disease.~   "
169158|NCT01351415|"~     This open-label, randomized, multicenter study will evaluate the efficacy and safety of~     bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants~     with advanced non-squamous NSCLC. Participants will be enrolled at documentation of~     progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a~     platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance~     treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to~     receive either bevacizumab plus SOC treatment or SOC treatment alone.~   "
169159|NCT01351402|"~     This study will investigate the effects of 15 minutes of massage compared to 15 minutes of~     quiet rest on physiological variables. Specifically, the investigators will measure the~     effects on levels of the social hormone oxytocin, and on other physiological variables that~     interact with oxytocin or that may be influenced by massage (including ACTH, Beta-endorphin,~     and IL-1alpha). The investigators will also investigate whether, in the case of hormones~     changes, these influence social decision making.~   "
169160|NCT01351389|"~     This brief alcohol and sexual risk taking intervention has the potential to influence the~     public health by reducing alcohol use and sexual risk taking behavior in individuals who are~     seeking treatment in an Emergency Department.~   "
169161|NCT01351376|"~     This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast~     cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy~     (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition~     of LLLT to CDT will result in statistically significant improvements and greater long-term~     benefits as measured by changes in arm volume and girth, pain levels, tissue texture,~     symptoms experienced, and quality of life when compared to the benefits of CDT alone for the~     treatment of breast cancer-related lymphedema.~   "
169162|NCT01351363|"~     Following arthroscopic shoulder surgery a small but significant number of people suffer~     severe postoperative pain.~      This study aims to predict which patients are at risk of developing severe post operative~     pain so that they may be targeted with a more aggressive post operative pain regimen.~   "
169163|NCT01351350|"~     This is a Phase I, open label, dose escalation study of oral administration of MLN0128 in~     combination with paclitaxel, with/without trastuzumab, in participants with advanced solid~     malignancies.~   "
169245|NCT01350284|"~     The purpose of this study is to determine whether 3 g cinnamon was sufficient to delay the~     gastric emptying rate of a high-fat solid meal and subsequently reduce postprandial blood~     glucose and lipid responses, oxidative stress, arterial stiffness and satiety responses in a~     healthy adult population.~   "
169164|NCT01351337|"~     Resection of brain tumors in eloquent areas involves the risk of postoperative motor~     deficits. For brain tumors within or adjacent to the eloquent area, maximizing tumor~     resection while preserving motor function is crucially important.we used DTI-based~     tractography to visualize the spatial relationship between brain lesions and the nearby~     pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional~     connections of the illustrated PT by direct electrical stimulation. We evaluated the~     reliability of DTI-based tractography for PT mapping using intraoperative subcortical~     stimulation ) and the usefulness of the combination of two techniques.~   "
169165|NCT01351324|"~     Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and~     insulin sensitivity but the impact of NEFA composition is unknown.~      The objective was to test the effect of acute elevation of NEFA enriched with either~     saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated fatty acids (LC n-3~     PUFA) on postprandial vascular function measured via flow-mediated dilatation (FMD), laser~     Doppler iontophoresis (LDI) and digital volume pulse (DVP), followed by a~     hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.~   "
169166|NCT01351311|"~     The aim of the present study is to assess the effectiveness of resistance training with swiss~     ball in the treatment of patients with ankylosing spondylitis.~   "
169167|NCT01351298|"~     Flexible nasendoscopy involves passing a soft, thin, endoscope through the nose. This~     diagnostic procedure is often essential for assessment of a child by an Otolaryngologist in~     outpatients. The purpose of this randomized controlled double-blind study is to determine~     whether there is a difference in the degree of discomfort experienced by children undergoing~     flexible nasendoscopy, after receiving one of three different intranasal sprays: (A) placebo~     (isotonic saline solution), (B) decongestant (0.05% xylometazoline hydrochloride), or (C)~     decongestant with local anesthetic (0.05% xylometazoline hydrochloride with 1% lidocaine~     hydrochloride).~      Null hypothesis: There is no difference in the degree of reported discomfort experienced~     (using a validated pediatric pain score) by children undergoing flexible nasendoscopy, after~     receiving either intra-nasal topical placebo, decongestant, or decongestant with local~     anesthetic.~   "
169168|NCT01351285|"~     It has been reported that target-controlled infusion of remifentanil can reduce cough against~     endotracheal tube during emergence from general anesthesia. We hypothesized that effective~     concentration of remifentanil for preventing cough during anesthetic emergence varies~     depending on the type of main anesthetic agents which is administered with remifentanil~     during general anesthesia. The purpose of this study is to evaluate the effective~     concentrations of remifentanil to prevent coughing during emergence from general anesthesia~     according to main anesthetic agent (sevoflurane, desflurane, and propofol).~   "
169169|NCT01351272|"~     In this study the investigators will measure the functional brain activity of adult Attention~     Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT genotype,~     during a Working Memory Paradigm, before and after a placebo controlled treatment with MPH~     for 6 WEEKS. Within this design, the investigators will be able to evaluate the therapeutic~     effect of MPH treatment on cognitive functions.~   "
169170|NCT01351259|"~     Underinflation and overinflation of tracheal cuff are common in intubated patients, including~     those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the~     efficiency of a pneumatic device in controlling cuff pressure.~   "
169171|NCT01351246|"~     Cognitive-behavioral based guided self-help for parents of children with~     Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and~     effectiveness study. The treatment is offered under routine-care conditions of the~     health-care system in Germany. Practicability, treatment participation and effectiveness is~     documented and tested in a one-group pre-test/post-test design.~   "
169172|NCT01351233|"~     The purpose of this study is to evaluate the stability and efficacy of The AcrySof Toric~     intraocular lens in the bag in high myopic subjects.~   "
169173|NCT01351220|"~     Filipino Americans have lower rates of colorectal cancer (CRC) screening, later stage of~     diagnosis and poorer survival relative to other racial/ethnic groups. To address this~     disparity, the investigators developed a multi-component intervention to increase CRC~     screening and have determined its efficacy in a randomized trial (Maxwell,et. al., 2010).~     This study aims to determine how an intervention to increase CRC screening can best be~     integrated within the cultural norms and existing structures of churches and community based~     organizations (CBOs) with predominantly Filipino American membership to ensure broad~     dissemination to those in need of screening.~      The investigators will provide our partner CBOs with resources and technical assistance,~     including training of community volunteers as health advisors, to enable them to promote CRC~     screening to their constituents. Using a scientifically rigorous research design, the~     investigators will compare two dissemination strategies: Basic dissemination which consists~     of a single kick-off event during which community health advisors will receive print~     materials and FOBT kits for distribution and training on how to conduct educational~     small-group sessions; and Organizational dissemination aimed at integrating CRC screening~     dissemination into organizational practices and processes that can be sustained after the end~     of the study. The study will be implemented in 20 CBOs and will train 100 community health~     advisors (CHAs). The impact of the two dissemination strategies will be comprehensively~     assessed by collecting data at the CBO level, from the CHAs and from 1000 Filipino American~     participants. The investigators will compare the proportion of Filipino American participants~     who obtain CRC screening by dissemination strategy, but the investigators will also assess~     how many are reached, if the intervention is implemented as planned, how CBOs support the~     screening efforts at their regular activities, and if CBOs and CHAs maintain their efforts~     over the 4 years of the study.~      The investigators hypothesize that CBOs can implement evidence-based strategies to promote~     CRC screening and CHAs in the organizational dissemination arm will reach more participants~     and more screened participants than CHAs in the basic dissemination arm; and organizations in~     the organizational dissemination arm will adopt more CRC screening activities and maintain~     these better than organizations in the basic dissemination arm.~   "
169174|NCT01351207|"~     The objective of this randomized, double-blinded, placebo-controlled, 3-way crossover pilot~     study is to determine whether eggs can favorably alter biomarkers of postprandial metabolism~     when included with other cooked breakfast foods typically selected by older Americans.~   "
169184|NCT01351077|"~     The aims of this study are to (1) Expand and modify an existing computer-based decision~     support system (CHICA) to include the 2006 AAP developmental surveillance and screening~     algorithm; (2) Evaluate the effect of the CHICA system on the developmental surveillance and~     screening practices of four pediatric clinics; (3) Evaluate the effect of the CHICA system on~     referrals for developmental and medical evaluations as well as early developmental~     intervention/early childhood services for those children identified as having concerning~     developmental screening results; and (4) Develop a cohort of children with identified~     developmental disabilities that can be followed over time in order to look at the end~     results/effects of developmental screening~   "
169919|NCT01341457|"~     The primary objective of this study is to evaluate the safety and tolerability of LY2603618~     in combination with the standard dose of gemcitabine up to the global recommended dose of~     LY2603618 in Japanese patients with solid advanced or metastatic tumors.~   "
169175|NCT01351194|"~     Recently, a clinical trial has shown that PRFA is as effective as HR for small HCC in terms~     of overall survival and disease-free survival. This has prompted some authors to suggest that~     PRFA could be more suitable than HR for early stage HCC. Some authors also have suggested~     that PRFA can be considered the treatment of choice for patients with single HCC ≤ 2.0 cm,~     even when HR is possible. On the other hand, some tumors (subcapsular location, adjacent to~     intestinal loops or main bile ducts) may be unsuitable for PRFA because of the risk of~     bleeding, tumor seeding, bile leakage, perforation, and so on. Furthermore, in our previous~     experience, some tumors (with deep locations, which were included as central HCC) may be~     also unsuitable for HR because of risks of more injury of normal liver tissue, blood loss~     after resection, and so on. Therefore, the appropriate therapeutic option for these HCC~     tumors ≤ 2 cm, especially for central HCC, is still under debate. To clarify this issue, the~     investigators conducted a study that included a consecutive series of patients with single~     resectable HCC < 2.0 cm in diameter, who underwent PRFA or HR.~   "
169176|NCT01351181|"~     Type II diabetes is an important condition with a UK prevalence of 3.54% affecting~     approximately 2.5 million people across the country. Diabetics have a fivefold increased risk~     of cardiovascular disease and over 65% of diabetics will die from coronary heart disease or~     stroke. Exercise is one of the management tools along with medication and weight reduction~     available to improve diabetic control reducing morbidity and mortality. Exercise promotion~     might be more effective at a population level if it could be incorporated in a simple form as~     part of pre-existing routine care. This case control study seeks to assess the effectiveness~     of written exercise advice given to Type II diabetics at the time of their annual review. The~     study will be open to all Type II diabetics in a single general practice attending their~     routine nurse led annual review. The intervention uses leaflets prepared as part of a~     previous study the Time2Act study and assessment will be by self-reported questionnaires.~     Follow up will be over 12 months but the study design will allow for longer durations.~     Previous studies have demonstrated the effectiveness of exercise as an intervention but have~     often been hospital-based and used exercise interviews as the main intervention rather than~     incorporating exercise advice into structures already established in routine Primary Care. If~     this study demonstrates that a simple intervention carried out as part of routine care has a~     positive effect if only at a low level then disseminating this knowledge across the country~     would bring significant benefits to Type II diabetics.~   "
169177|NCT01351168|"~     Levodopa treatment is associated with long-term complications. Dopamine deficiency is~     associated with abnormal activity in certain parts of the brain. Zolpidem may change this~     abnormal activity and, by doing so, may work in a different way than levodopa to help~     parkinsonism.~      The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving~     motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind,~     cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2~     doses of ZLP in a randomized order on 4 different occasions, about one week apart.~   "
169178|NCT01351155|"~     In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV),~     the main complication of the use of the mask is the development of decubitus, sometimes so~     severe and painful as to force a suspension of the NIV itself . The lesions are mainly~     located at the nasal bridge, as at this level the skin thin and placed directly on the bone~     is particularly vulnerable to the injury as consequence of the friction and pressure induced~     by the movement of the mask. The strategy of prevention and treatment commonly adopted is the~     application of hydrocolloids.~      However, precise data are lacking about the demonstration of the effectiveness of these~     devices and the possibility of using other protective devices.~      The purpose of this study was to evaluate the usefulness of large-scale three different~     systems of protection vs. no protection in preventing the development of decubitus lesions in~     patients receiving NIV for an episode of ARF.~   "
169179|NCT01351142|"~     Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks~     of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in~     the brain of patients with AD.~      The main objective of our study is to analyse the correlation between the value of plasma~     cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive~     decline in AD over a 2-year follow-up.~      Secondary objectives include:~        -  the predictive value of the cytokines on the cognitive decline after 6 months and one~          year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25)~        -  correlation between plasma cytokines levels and expression of the protein kinase PKR~          (involved in death cell) in blood mononuclear cells.~   "
169180|NCT01351129|"~     The primary purpose of this study is to evaluate the pharmacokinetics, safety and~     tolerability three different formulations of PF-04991532 in healthy adult subjects.~   "
169181|NCT01351116|"~     A trial to improve the quality of life of patients with advanced non-small cell lung cancer~     (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external~     radiation with or without high dose internal radiation.~   "
169182|NCT01351103|"~     This primary purpose of this study is to find the recommended dose of LGK974 as a single~     agent and in combination with PDR001 that can be safely given to adult patients with selected~     solid malignancies for whom no effective standard treatment is available.~   "
169183|NCT01351090|"~     This was a randomized, double blind, placebo-controlled study in subjects who have undergone~     major surgery. Each subject's study participation consisted of a screening visit, a 2-day~     treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned~     to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain~     intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter,~     subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain~     not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered~     via patient controlled analgesia (PCA).~      The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN)~     doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and~     tolerability of this dosing regimen.~   "
169308|NCT01349465|"~     The purpose of this study is to investigate durability of SVR in chronic HCV patients who~     achieved SVR in the previous study with TMC435-containing regimen and time for resistance~     associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in~     the previous study with TMC435-containing regimen.~   "
169185|NCT01351064|"~     Attention-deficit/hyperactivity disorder (ADHD) is the most commonly diagnosed behavioral~     disorder in children. Prevalence rates in the United States range from 2% to 18% depending on~     diagnostic criteria and population studied. Primary care physicians, especially~     pediatricians, have historically played a large role in the diagnosis and treatment of ADHD.~     Despite the existence of authoritative guidelines to assist primary care physicians, ample~     evidence demonstrates that they continue to diagnose and treat this disorder suboptimally.~     This is due, in part, to a lack of training and cumbersome delivery system designs. Modern~     computer decision support strategies offer the best hope of equipping general practitioners~     to deal with the mental health epidemic of ADHD.~      The investigators have developed a novel decision support system for implementing clinical~     guidelines in pediatric practice. CHICA (Child Health Improvement through Computer~     Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a~     dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing~     electronic medical record systems. The result is a system that both delivers just-in-time~     patient-relevant guidelines to physicians during the clinical encounter, and accurately~     captures structured data from all who interact with it. Preliminary work with CHICA has~     demonstrated the feasibility of using the system to implement and evaluate clinical~     guidelines. The investigators propose to expand CHICA to include ADHD diagnosis and treatment~     guidelines. The investigators hypothesize that implementation of the ADHD guidelines will~     result in better outcomes, including higher rates of adherence to recommendations and~     improved patient functioning.~   "
169186|NCT01351051|"~     This study will aim to identify genetic, medical, dietary and environmental factors~     associated with the development of endometrioma and/or deep infiltrating endometriosis in~     order to move towards early diagnosis and implementation of potential preventative measures.~   "
169187|NCT01351038|"~     This is an open label, multicenter, single-arm phase II trial with primary~     eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with~     resectable, histologically proven gastric or esophageal cancer.~   "
169188|NCT01351025|"~     ACTG A5275 was a prospective, double-blind, randomized, placebo-controlled cross-over design~     pilot study evaluating the effect of atorvastatin on biomarkers of inflammation,~     coagulopathy, angiogenesis, and T-lymphocyte activation in HIV-1 infected individuals with~     suppressed HIV-1 RNA on stable protease inhibitor based antiretroviral therapy with fasting~     LDL cholesterol < 130 mg/dL.~      Atorvastatin is a drug approved by the Food and Drug Administration (FDA) for treating high~     cholesterol. Atorvastatin has also been able to lower the level of inflammation blood tests~     in certain other diseases but has not been studied for this purpose in people who have HIV.~     The main goal of this experimental study is to see how taking atorvastatin affects~     inflammation blood tests in people infected with HIV who do not need to take medicine for~     high cholesterol. In addition to observing the effects of atorvastatin on the level of~     inflammation measured in the blood, this study evaluated if atorvastatin is safe for people~     with HIV who are also taking medication for HIV.~   "
169189|NCT01351012|"~     The purpose of the study is to examine how the consumption of different dietary oil varieties~     affects a broad range of metabolic responses that are important in the development of~     cardiovascular diseases. This study will examine the relationship between dietary oil~     consumption and arterial function, blood fat content, and blood markers of cardiovascular~     disease risk. Additionally, the efficiency of the body in converting fat from dietary oils~     into other specific fat compounds with know health benefits will be examined. Also, the~     correlation between psychosocial parameters and vascular function will be studied.~   "
169190|NCT01350999|"~     The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD)~     or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in~     participants with hypertriglyceridemia undergoing lifestyle modification.~   "
169191|NCT01350986|"~     The efficacy of cognitive-behavioral based guided self-help for parents of children with~     externalizing problem behavior is tested in a randomized clinical trial. Parents work through~     cognitive-behavioral self-help booklets and additionally receive counseling telephone calls~     every two weeks. In the control condition parents are provided non-directive self-help~     booklets and additionally receive counseling telephone calls. It is hypothesized that the~     cognitive-behavioral treatment is superior.~   "
169192|NCT01350973|"~     The purpose of this study was to determine the efficacy and safety of TAK-085, once daily~     (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily~     (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.~   "
169193|NCT01350960|"~     The purpose is to study Safety and Tolerability.~   "
169194|NCT01350947|"~     The primary objective of this study is:~      Response to treatment will be evaluated according to the revised International Working Group~     (IWG) categories natural history, hematologic improvement and cytogenetic response1;2. The~     primary objective is:~      To determine the rate of complete hematologic response and hematologic improvement (according~     to IWG 2006 criteria) in CMML patients treated with 5-azacitidine.~   "
169195|NCT01350934|"~     This study will evaluate whether the once weekly administration of the combination tablet~     alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD)~     more than the daily use of calcitriol.~   "
169196|NCT01350921|"~     Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken~     together in healthy volunteers~   "
169197|NCT01350908|"~     Circulating tumor DNA detection and quantification in patients with ovarian cancer.~   "
169198|NCT01350895|"~     To study the clinical and biochemical characteristics women with polycystic ovary syndrome~     (PCOS) in different aged groups.~   "
169199|NCT01350882|"~     Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a~     composite TREATMENT FAILURE~   "
169200|NCT01350869|"~     The objective of this study is to evaluate effectiveness and safety of everolimus-eluting~     stents (XIENCE, Abbott) in the real world daily practice as compared with first-generation~     drug-eluting stents (sirolimus-eluting stents).~   "
169349|NCT01348932|"~     The objective of this study was to investigate the relationship between single nucleotide~     polymorphism of chitinase 3-like 1 and human asthma.~   "
169201|NCT01350856|"~     Because the artemisinins are the most potent antimalarial drugs, the reduction in parasite~     numbers is rapid. Therefore, early measures of reducing parasite counts are needed. This~     study will look at conventional markers of parasite reduction e.g. parasite clearance time,~     parasite reduction ratio, and the time to achieve a fall of 50%, 90% and 99% of the~     pre-treatment parasitaemia.~      Defining artemisinin resistance requires the use of artesunate (AS) alone because it is now~     appreciated that the partner drug in a combination treatment has a significant impact on the~     rate of parasite clearance. This study will dose patients for 3 days with AS alone (or longer~     until parasites clear) and measure the parasite count frequently in order to be able to~     define an accurate regression line of a graph of the natural logarithm of the parasite count~     (Y axis) versus time (X axis). This will be followed by a full course of an artemisinin~     combination therapy (ACT). Two different dose regimens of artesunate will be compared at all~     sites except those in western Cambodia, as unpublished observations from the Thai-Myanmar~     border suggest the standard lower daily dose of 2mg/kg may enable the earlier detection of~     low level resistance than a 4mg/kg daily dose.~   "
169202|NCT01350843|"~     The aim of this study is primarily to investigate the ability of antioxidants found in orange~     juice (OJ) to improve the serum lipid profile. Overweight or mildly obese men, who are~     otherwise healthy, but with elevated serum total cholesterol concentration will be recruited.~     The time commitment for subjects is ~14wks. Subjects will attend the laboratory on 5~     occasions after fasting from midnight. The 1st is a medical screening. Laboratory visits 2 &~     5 will take ~90min and will be separated by 3 months, during which time subjects will consume~     250ml of an orange drink (either OJ or an orange flavoured control drink) once a day. During~     visits 2 & 5, subjects will have a scan to assess their %body fat using a low-dose x-ray~     machine, a 20ml blood sample taken and a small sample of fat tissue (about the size of a~     haricot bean)taken from underneath the skin of the belly. Subjects will record their food~     intake for 3-days in weeks 3, 7 and 11 of consuming the drink, and come to the lab for visits~     3&4 during weeks 4&8. Laboratory visits 3&4 repeat measurements taken in the 1st (screening)~     visit.~   "
169203|NCT01350830|"~     Chronic pain rate is from 0 to 50% after prosthetic groin hernia repair. We compared two~     anterior technique positioning the mesh in the pre-trasversalis space vs preperitoneal space~     to assess any differences in term of chronic pain and early and late complications~   "
169204|NCT01350817|"~     This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib~     plus docetaxel therapy versus docetaxel alone as second line treatment in patients with~     recurrent non-small cell lung cancer. Patients will be randomized to receive in group~     1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per~     os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.~      The anticipated time on study treatment is until disease progression. Target sample size is~     156.~      The main of this study is to determine the relevance of the association sequential erlotinib~     and docetaxel in terms of progression-free survival .~   "
169205|NCT01350804|"~     The core and extension studies assessed the safety and efficacy of secukinumab when added to~     a background therapy in patients with active rheumatoid arthritis who are intolerant to or~     have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab,~     placebo or abatacept (active comparator). The core study was completed. However, the~     extension study was prematurely terminated after the primary endpoint analysis of the core~     study at week 24 had demonstrated numerically higher efficacy for the active comparator~     abatacept compared to secukinumab.~   "
169206|NCT01350791|"~     This study is a non-randomized, prospective, open-label registry to compare the efficacy and~     safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients~     with coronary artery disease.~   "
169207|NCT01350778|"~     The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in the~     real world daily practice as compared with first-generation drug-eluting stents (sirolimus-~     or paclitaxel-eluting stents).~   "
169208|NCT01350765|"~     The present study will be carried out in close collaboration with the National Program for~     Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering~     60% of the rural population of Pakistan. A team of Lady Health Workers and a Traditional~     Birth Attendant will provide care to the mothers and newborns at household level. A Basic~     Health Unit will take care of non complicated referrals and provide injectable antibiotics~     for neonatal sepsis. Complicated (definitions given in methods section) cases will be~     referred by the LHWs/BHUs to the District Headquarter Hospital which will have a functioning~     neonatal care unit. The District Health Services, Naushero Feroz, Provincial Department of~     Health, Sindh and the Federal Ministry of Health are study collaborators, therefore,~     guaranteeing scaling up of interventions at national level.~      Hypothesis:~      In comparison to a basic package of existing training program of LHWs, enhanced training of~     LHWs and TBAs in the early recognition and management of birth asphyxia, serious newborn~     infections and LBW (combined with prompt referral) will result in an additional 30% reduction~     in neonatal mortality.~   "
169209|NCT01350752|"~     The objective of the REACT project is to evaluate the effectiveness and cost-effectiveness~     implications of interventions designed to improve health worker practice in providing~     treatment for uncomplicated malaria to febrile patients attending health facilities in~     Cameroon and Nigeria.~   "
169210|NCT01350739|"~     The aim of this study is to access to the abdominal cavity using different incision-types~     within the umbilical area.~      Effects of different incisions on scarring and on the umbilical form will be investigated.~   "
169211|NCT01350726|"~     The aims of this study were divided into three parts:~        1. To develop a new software to carry out the functional-three- dimensional-reconstruction~          of the liver by 99mTc-GSA-SPECT scintigraphy~        2. To probe a new dynamic model of the metabolism of the 99mTc-GSA.~        3. To evaluate the liver function by 99mTc-GSA-SPECT scintigraphy before surgical~          treatment.~      Study design:~        1. Collectivity type: Prospective，randomized, controlled, multi-central clinical study.~        2. Patients: The subjects were from different hospitals including: Peking Union Medical~          College Hospital (PUMCH).~      Study arrangement:~      This study was consisted of three parts:~   "
169350|NCT01348919|"~     The primary objective of the study is to determine the maximum tolerated dose (MTD) of~     CEP-18770 in combination with lenalidomide and dexamethasone in patients with relapsed or~     refractory multiple myeloma.~   "
169213|NCT01350700|"~     In previous study (MW2004-011-02), patients with burn wounds had their damaged skin removed~     by either standard of care treatment or by Debrase Gel Dressing (DGD), which is composed of~     enzymes that dissolve the damaged skin selectively (DGD removes only the damaged skin and not~     other parts of the skin).~      The burn wound, like any other wound, heals by the formation of scar at the injured site in~     order to replace the destroyed tissues. Scarring is not a static process, but rather a~     dynamic one, changing over time, especially during the first 24 months post-injury.~      Scars and patients' quality of life from two treatment arms (DGD and SOC) will be compared in~     order to evaluate the long term influence of damaged skin removal and wound care techniques~     on scar formation and maturation.~   "
169214|NCT01350687|"~     Pulmonary hypertension is a new complication described in hemodialysis patients. in the last~     year these patients were treated by calcium carbonate orally to control serum phosphor.~     Calcium phosphor deposits in pulmonary artery can explain this phenomena. The investigators~     want to investigate the new phosphor non calcium containing agents in hemodialysis patients~     and to measure the pulmonary pressure.~   "
169215|NCT01350674|"~     This is an observational prospective study. Role of EBUS-TBNA (endobronchial ultrasound~     transbronchial needle aspiration) is evaluated to diagnose tuberculosis in mediastinal and/or~     hilar lymph nodes.~      The investigators analyse the specificity and sensibility of this technique to diagnose~     tuberculosis in mediastinal and/or hilar lymph nodes.~      Patients with mediastinal and/or hilar lymph nodes on X-ray or CT thorax where a tuberculosis~     is the most probable cause and who have no parenchymal lesions suspected for tuberculosis and~     without other lymph nodes that are more easily accessible or palpable will be included in~     this study.~   "
169216|NCT01350661|"~     This observational study aims to assess the correlation between many questionnaires designed~     to assess the level of control of asthma. The five questionnaires will be submitted, at the~     same time and in a random order, to asthma patients. Some other parameters will be recorded~     (e.g. lung function, epidemiological data). The hypothesis is that the results of the~     questionnaires will be the same. If not, we will try to understand why.~      The investigators will include 100 patients, stratified with relation to their level of~     asthma severity (25 patients for each level of severity - described by the GINA guidelines).~   "
169217|NCT01350648|"~     Background:~      - Hepatitis B and hepatitis C can cause liver damage. They can also cause serious illness,~     including liver cancer, and even death. This study will follow people who have hepatitis B or~     hepatitis C. The purpose is to understand more about how these viruses affect the immune~     system over the long term (up to 10 years). The study will also compare how these viruses~     affect people who do and do not have HIV, the virus that causes AIDS.~      Objectives:~        -  To do a long-term study of hepatitis B and hepatitis C infection.~        -  To study the effects of hepatitis B and hepatitis C infection in people do and do not~          have HIV.~      Eligibility:~      - People at least 18 years of age who have hepatitis B or hepatitis C and have a regular~     doctor for their medical care.~      Design:~        -  Participants will be screened with a physical exam and medical history. Those who do not~          have a regular doctor to provide medical care during the study will not be able to take~          part.~        -  Participants will have yearly visits with study researchers for up to 10 years. These~          tests will be done at each visit.~        -  Medical history and physical exam.~        -  Questionnaire (optional) on emotions, sexual behaviors, use of alcohol and drugs, and~          quality of life.~        -  Blood and urine tests, including HIV testing.~        -  Tissue sample collections for those who have had a liver or other tissue biopsy.~        -  Participants may leave the study at any time. They will receive the standard of care~          from their regular doctor throughout the study.~   "
169218|NCT01350635|"~     The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins~     exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to~     grass pollen allergic patients~   "
169219|NCT01350622|"~     The primary objective of this study is to compare the pain relieving effect and speed of~     onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a~     growth curve approach to pain measurement. The investigators will test the hypothesis that~     PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The~     secondary goal of the proposed work is to discover and model the onset and course of pain~     relief during the emergency department (ED) visit.~   "
169220|NCT01350609|"~     Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence~     of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the~     corresponding loose combination under fed conditions.~   "
169221|NCT01350596|"~     An open label, randomized, 2x2 crossover, single dose, phase 4 study to determine the~     pharmaceutical bioequivalence of ibuprofen 50mg/ml (laboratórios pfizer ltda) oral suspension~     versus alivium ® 50mg/ml (mantecorp indústria química e farmacêutica ltda.) Oral suspension,~     in healthy fasting volunteers.~   "
169222|NCT01350583|"~     The purpose of this study is to:~        -  Determine how well people tolerated sodium bicarbonate taken by mouth in higher doses~          than those usually given for heartburn.~        -  Determine if sodium bicarbonate can reduce cancer-related pain. Right now, the~          investigators do not know for sure if these higher doses will be well tolerated or if~          they will reduce the pain associated with cancer. The investigators are doing this study~          to see if sodium bicarbonate is well tolerated and if it can reduce the requirements for~          pain medications.~   "
169223|NCT01350570|"~     This trial is to assess the effectiveness of three types of acupuncture for patients with~     functional diarrhea comparing to a positive drug control.~   "
169224|NCT01350557|"~     Hip fracture in the elderly is associated with excess mortality of 5 to 20%, and mobility~     problems that usually results in costly hospital stays and lengthy rehabilitation procedures.~     The purpose of this study is to compare the costs and effectiveness of three care models-~     acute/sub-acute, comprehensive, and routine care models for hip fractured elders in Taiwan.~   "
169225|NCT01350544|"~     The investigators hypothesize that participants in the treatment advocacy intervention will~     show significantly better HIV treatment adherence than will participants in the no-treatment~     (wait-list) control group.~   "
169944|NCT01341132|"~     This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic~     resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma~     (Liver Cancer) comparison to multi-detector computed tomography (CT).~   "
169226|NCT01350531|"~     To date, attempts to construct effective weight loss interventions for African American~     adolescents with obesity (AAAO) have largely failed. While effective weight loss strategies~     and skills have been identified, lifestyle changes require youth and their families to learn~     new dietary and exercise behavior with repeated skills practice in natural ecology of the~     family. A major barrier is motivation of both parents and adolescents to engage in treatment~     and to adhere to behavior change recommendations. Advances in the science of increasing human~     motivation (both intrinsic and extrinsic) that could inform intervention development for~     minority youth with obesity have been insufficiently applied to date to the process of~     intervention development. The study brings together a multidisciplinary research group~     comprised of obesity intervention researchers with extensive experience in adolescent health~     behavior change research, basic behavioral scientists with experience in motivation and~     learning research and communication scientists with experience in provider-family~     interactions within urban populations. Basic science obesity researchers will inform~     intervention development by contributing a strong background in the physiological correlates~     of obesity. Finally experts in the area of community interventions for African American~     adolescents will contribute to the effective transport of these interventions to real-world~     settings. The overarching aims of the study are: To refine intervention protocols from our~     preliminary studies that maximize adolescent and parent skills, informed by learning theory,~     through the use of home and community-based interventions in which in-vivo opportunities are~     used to promote practice in making changes in dietary, exercise and sedentary behaviors in~     AAAO and their families (PHASE I); To develop intervention protocols that utilize findings~     from basic science regarding intrinsic and extrinsic motivation to maximize adolescent and~     family adherence to recommendations for obesity-related behavior change in AAAO and their~     families (PHASE I); To develop an adaptive intervention using a sequential multiple~     randomized assignment trial (SMART design) (PHASE II); To refine the intervention including~     qualitative analysis of interviews from participant families and to develop further community~     participation in preparation for a confirmatory randomized clinical trial (PHASE III).~      There are two proposed hypotheses for this study:~        1. Families initially receiving home/community delivery of Motivational Interviewing~          (MI)/skills training will show greater weight loss over the course of the study than~          families receiving initial office-based delivery of MI/skills training.~        2. Non-responders receiving home/community delivery of MI/skills training with Contingency~          Management (CM) will show greater weight loss than non-responders receiving MI/skills~          training alone.~   "
169227|NCT01350518|"~     The purpose of this research study is to determine whether increased intake of dietary fiber~     during a 12-week, low-calorie weight loss intervention affects abdominal fat change and~     improves cardiovascular risk factors in African-American women more than a standard weight~     loss intervention.~      The investigators are testing two main hypothesis:~      Hypothesis 1: Women in the high dietary fiber intervention group will lose significantly more~     abdominal fat around their organs than women in the standard fiber group.~      Hypothesis 2: Women in the high dietary fiber intervention group will have lower blood~     pressure, fasting glucose, fasting lipids and inflammatory factors at 3-months compared to~     women in the control group.~   "
169228|NCT01350505|"~     To examine the change in balance that occurs in older individuals when exposed to different~     colored lights at night.~   "
169229|NCT01350492|"~     This study is intended to test the influence of weight training on physical symptoms,~     physical activity and brain structure and function in Gulf War Veterans with chronic~     widespread muscle pain.~   "
169230|NCT01350479|"~     Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and~     mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by~     health care workers. The use of gowns, gloves and hand washing prevents this spread; however,~     their use detracts from a patient-centered, home-like environment which is an important~     priority for nursing homes. The goal of this project is to determine when it is most~     important for health care workers to wear gowns and to wash their hands when caring for MRSA~     colonized Veterans in community living centers.~   "
169231|NCT01350466|"~     The pathophysiology of chronic rhinosinusitis (CRS) is complex and involves several immune,~     infectious and anatomic factors. When medical therapy fails, functional endoscopic sinus~     surgery (FESS) is the therapy of choice. From literature it is known that 10% of patients~     that undergo FESS, need revision surgery within the 3 years following initial surgery. Causes~     of failure are multiple and not fully understood.~      As is the case in patients suffering from occupational rhinitis (OR), a subgroup of patients~     with severe and/or therapy resistent rhinosinusitis may suffer from mucosal pathology induced~     by occupational factors as well. No data are currently available on how these factors may~     contribute to the disease manifestation, whereas negligence of these factors as potential~     causes of disease may lead to the chronicity of rhinosinusitis, aggravate the mucosal~     condition and even give rise to the induction of bronchial symptoms. There exists no~     documentation on the role of the occupational agents on chronic sinus disease.~      This prospective study aims at providing data about the exposure levels of patients that~     undergo sinus surgery and correlate them with both subjective and objective postoperative~     parameters. This will be done by providing a questionnaire that was developed at our~     department to all patients that are planned for sinus surgery at the participating centers.~     This questionnaire asks for medical history, current sinonasal symptoms, professional history~     and recreational occupation. An extensive list of occupational agents is given and patients~     are asked to indicate those that they encounter at work or during recreational activities.~     This will be followed by an extensive clinical investigation including nasal endoscopy. These~     investigations (questionnaire and clinical examination) will be repeated at 3 months and 12~     months after surgery.~   "
169232|NCT01350453|"~     When a person has had a stroke they often lose their confidence, motivation and the ability~     to move one arm and hand. Recent research has shown that intensive exercise assists recovery~     of movement, but people are often discouraged by slow progress and stop using their weak~     limb.~      A new idea, called Constraint Induced Therapy (CIT), has been shown to overcome this habitual~     'non-use'. CIT involves wearing a mitt on the unaffected hand for several hours a day to~     prevent it from being used. Use of the weak arm and hand is encouraged by intensive~     exercises. CIT is not available in the NHS because of lack of therapist time for supervision~     and patients lack the confidence and motivation to carry out CIT alone at home.~      This study will have two stages.~      Stage 1.~      The aim of this part of the study is to develop a web-based therapy programme ('LifeCIT') to~     support patients carrying out CIT at home (with their carer where possible) with online~     therapist support. The investigators will develop the therapy programme working closely with~     at least 12 patients, 6 carers and 6 therapists to identify and resolve any problems.~      Stage 2~      The investigators will then carry out a pilot trial in three centres with 40-60 patients who~     have just been discharged from hospital and who have loss of arm and hand function. To test~     LifeCIT the investigators will randomly allocate patients to receive either the LifeCIT~     intervention or usual care. A researcher, who doesn't know which group patients have been~     allocated to, will measure their arm and hand function, record the problems this causes and~     how it affects their quality of life. Tests will be repeated after treatment (3 weeks) and 6~     months later. The investigators will also examine the cost-effectiveness of treatment and ask~     both therapists and patients for their views.~   "
169233|NCT01350440|"~     This is a preliminary study to determine the safety and efficacy of intravenous immune~     globulin in treating Spinocerebellar Ataxia. The investigators aim to assess changes in~     clinical measures of disease severity before and after treatment.~   "
169234|NCT01350427|"~     This study aims to evaluate the effects of leucine and branched-chain amino acids~     supplementation on skeletal muscle remodeling signaling pathways induced by resistance~     exercise.~   "
169351|NCT01348906|"~     This study aims to determine the effect of intermittent normoxic cardiopulmonary bypass (CPB)~     on inflammatory response, oxidative stress and myocardial reperfusion injury in adult~     patients undergoing valve replacement. The investigators hypothesized that nuclear factor~     kappa B (NFkB) was involved in regulating gene expression of myocardial inflammatory factor.~   "
169235|NCT01350414|"~     The objective of this study is to evaluate durability of effectiveness (beyond one year) of~     the Alair System in patients with severe persistent asthma. The study will consist of~     Alair-group subjects who are currently in the follow-up phase (out to 5 years) of the AIR2~     Trial (Protocol #04-02, clinicaltrials.gov number NCT00231114).~      Durability of the treatment effect will be evaluated by comparing the proportion of subjects~     who experience severe exacerbations during the first year after Alair treatment with the~     proportion of subjects who experience severe exacerbations during subsequent 12 month periods~     out to 5 years.~      All Alair group subjects in the AIR2 Trial are being followed out to 5 years as per the AIR2~     Trial protocol. The data that are to be used to determine durability of effectiveness as~     described in the present protocol (Protocol #10-01) are being collected under the existing~     AIR2 Trial protocol (Protocol # 04-02).~      Study Hypothesis: An empirical demonstration of the durability of the treatment effect will~     be used to show that the proportion of subjects experiencing severe exacerbations for the~     first year compared with the proportions of subjects experiencing severe exacerbations in~     subsequent years do not get substantially worse.~      The primary statistical objective is to demonstrate that the proportion of subjects who~     experience severe exacerbations in the subsequent 12-month follow-up (for Year 2, Year 3,~     Year 4 and Year 5 [in 12-month periods]) is not statistically worse when compared with the~     proportion of first 12-months, which begins 6-weeks after the last Alair treatment. This~     objective will be met if the upper 95% confidence limit of the difference in proportions~     (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than~     20%.~   "
169236|NCT01350401|"~     The purpose of this early (phase I/II) clinical trial is to assess the effects (both good and~     bad) of genetically modified T cells after chemotherapy on your cancer and general health.~   "
169237|NCT01350388|"~     Hyperuricemia is emerging as a risk factor for development of diabetes and metabolic~     syndrome. Recently, it was shown in in-vitro cell culture experiments that hyperuricemia~     induces redox-dependent signaling and oxidative stress in adipocytes. By targeting levels of~     uric acid with febuxostat it is hypothesized that the levels of oxidative stress in adipose~     tissue (obtained by fat biopsy) will decrease.~      Primary aims of the study are to determine whether febuxostat therapy in overweight or obese,~     diabetic patients with stage 3 Chronic Kidney Disease (CKD) and high serum uric acid levels~        1. will affect adipose tissue concentrations of thiobarbituric acid reactive substance~          (TBARS), a marker of oxidative stress~        2. will affect adipose tissue expression and concentrations of adiponectin; and~        3. will affect urinary concentrations of transforming growth factor (TGF)- B1.~   "
169238|NCT01350375|"~     This study will investigate the therapeutic utility of BOTOX in reducing the degree of~     Forward Head Posture (FHP) with associated headache and myofascial pain, decreasing the~     frequency of headache, and improving the overall quality of life.~   "
169239|NCT01350362|"~     The main purpose of this study is to evaluate the cognitive changes after administration of~     tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in~     patients with mild to moderate Alzheimer's disease.~      After the 26 week core treatment period, the patients may continue in the study under blinded~     conditions for an optional extension period up to a maximum of 39 additional weeks (total~     study duration up to 65 weeks), until the last patient in the study has completed the 26 week~     of treatment.~   "
169240|NCT01350349|"~     Among older adults the combination of depression, cognitive impairment (memory problems), and~     disability contribute to a worsening of physical and mental health and to poor treatment~     outcomes. Antidepressants help fewer than 40% of depressed elders with memory problems~     achieve remission from their depression. Interventions involving talking therapy are~     underdeveloped and understudied. Therefore, this research study will test the efficacy of~     Problem Adaptation Therapy (PATH), a new home-delivered psychosocial intervention for elders~     with major depression, memory problems, and disability. PATH focuses on the subject's~     ecosystem (the patient, the caregiver, and the home-environment) and targets behavioral~     problems related to both depression and disability.~      PATH is delivered in a subject's home, where cognitively impaired, disabled elders face most~     of their difficulties. Local Home Delivered Meals programs will refer clients who have~     symptoms of depression and are interested in research. All participants will have an~     available caregiver (family, significant other, or professional) and will be randomized to 12~     weekly sessions of PATH or Supportive Therapy, the current standard of care for talking~     therapy. The study will test whether home-delivered PATH is more effective than~     home-delivered Supportive Therapy in reducing the subjects' depression and disability and in~     increasing self-efficacy over the 12-week treatment period.~   "
169241|NCT01350336|"~     As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific~     to generate data to assess the durability of the BT treatment effect as well as safety data~     in the intended use population in the United States.~   "
169242|NCT01350323|"~     This is a pilot, prospective, interventional, case-control study investigating aqueous levels~     of vascular endothelial growth factor (VEGF) in eyes with AMD-related neovascularization~     treated with intravitreal bevacizumab at the Medical Retina Department, University of Molise,~     Campobasso.~   "
169243|NCT01350310|"~     BACKGROUND. In patients with non-ischemic dilated cardiomyopathy, intracoronary stem cell~     transplantation has been shown to improve exercise capacity, reduce ventricular remodelling~     and improve 1-year survival. Pre-clinical data demonstrate that stem cell effects on the~     diseased heart can be further enhanced by direct intramyocardial delivery route.~      AIMS.~        1. To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with~          non-ischemic dilated cardiomyopathy.~        2. To directly compare clinical effects of intracoronary and intramyocardial stem cell~          delivery.~      METHODS. Of 60 patients with dilated cardiomyopathy, 30 will be randomized to intramyocardial~     transplantation of CD34+ cells (Study Group), and 30 will receive intracoronary stem cell~     therapy (Control Group). In both groups peripheral blood stem cells will be mobilised by~     daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and~     labelled with technetium. In the Study Group electromechanical mapping will be used to~     identify viable myocardium and intramyocardial injections in the target areas will be~     performed with NOGA catheter. In the Control group patients will undergo myocardial perfusion~     scintigraphy and CD34+ cells will be injected intracoronary in the artery supplying segments~     of reduced viability. Patients will be followed for 1 year. Primary endpoints will include~     changes in left ventricular ejection fraction and left ventricular dimensions (measured by~     echocardiography). Secondary endpoints will include changes in exercise capacity and changes~     in NT-proBNP values.~      HYPOTHESES.~        1. At 1 year, intramyocardial stem cell therapy will be associated with improved left~          ventricular ejection fraction, reduced left ventricular dimensions, improved exercise~          capacity and reduced levels of NT-proBNP.~        2. Beneficial effects of intramyocardial stem cell therapy will be superior to those~          observed with intracoronary stem cell delivery.~   "
169244|NCT01350297|"~     This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in~     tetraplegic patients with ventilatory insufficiency.~   "
169246|NCT01350271|"~     Mebendazole tablets which are produced by most pharmaceutical manufacturers, including the~     State Pharmaceutical Manufacturing Corporation (SPMC) of Sri Lanka, contain a mixture of~     polymorphs A and C. However, there is some evidence to show that mebendazole polymorph C is~     the only form effective against the soil-transmitted helminths. This protocol describes a~     stratified, randomized, placebo-controlled trial that examined the efficacy of different~     mebendazole polymorphs produced by the SPMC in the treatment of hookworm infections.~   "
169247|NCT01350258|"~     This is a research study involving the treatment of patients with hematological cancers with~     allogeneic (cells from a donor) hematopoietic stem cell transplant (HSCT). HSCT is often~     referred to as bone marrow transplant. Patients who are not expected to have long term~     survival after conventional therapy will undergo HSCT as a curative therapy after receiving~     front line therapy for their disease. This project is based on an HSCT approach that has been~     used at TJU since 2006 with the goal of optimizing this type of treatment further. In this~     new study, the investigators will substitute the chemotherapy agent, Melphalan (Mel), for~     cyclophosphamide (CY). Cyclophosphamide was used in the original trial. The research question~     is whether side effects are less using Mel and if donor T cells can be made tolerant to the~     recipient with the use of Mel. The proposed study is also more specific in terms of~     performance status and organ function entry criterion. The investigators observed in the~     original trial that patients with poor performance upon admission for transplant did not have~     as good outcomes.~      Because many older patients are treated according to this type of transplant, the~     chemotherapy and radiation used are less intensive than other types of transplant. The name~     for this in the transplant field is a reduced intensity hematopoietic stem cell transplant.~     The abbreviations most used in this document are RIC for reduced intensity conditioning, HSCT~     which refers to the transplant itself, and MEL which refers to the drug, Melphalan.~   "
169248|NCT01350245|"~     The primary hypothesis of this research study is that patients in remission undergoing~     myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas~     Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS)~     rate at 1 year that is the same or better than the historical DFS of patients with similar~     diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS~     rate of 50% or better at 1 year would meet the criterion for an effective alternative~     therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach~     over T-replete matched sibling HSCT.~   "
169249|NCT01350232|"~     This is a clinical research trial in which a novel preparatory regimen was developed for bone~     marrow transplant (BMT) which eliminates the primary obstacle to transplant, the lack of a~     matched sibling donor. It is believed this regimen is sufficiently efficacious and~     sufficiently gentle to apply to patients with sickle cell anemia and related disorders. It is~     proposed to characterize the efficacy and toxicity of this regimen in high risk patients with~     sickle cell anemia using criteria for patient selection that have been accepted in prior BMT~     trials in patients with sickle cell disease, specifically only the subset of patients whose~     prior clinical behavior indicates that they are at high risk for serious morbidity and early~     mortality. In addition, it is proposed to characterize the pathophysiology of a consistent~     febrile response seen in the haploidentical BMT regimen the investigators have developed at~     Thomas Jefferson University (TJU).~      The primary goal of this study is to determine the response rate to a reduced intensity~     conditioning regimen which consists of fludarabine, cytarabine, low dose total body~     irradiation and cyclophosphamide in patients with severe sickle cell anemia.~   "
169250|NCT01350219|"~     The translational potential to the clinical applications of cord blood stem cells has~     increased enormously in recent years, mainly because of its unique advantages including no~     risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid~     availability, and large resource worldwide. Human cord blood contains several types of stem~     cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess~     multiple biological properties including the expression of embryonic stem (ES) cell~     characteristics, giving rise to different types of cells and immune modulation. Specifically,~     CB-SC can function as an immune modulator that can lead to control of the immune responses,~     which could in turn be used as a new approach to overcome the autoimmunity of Type 1 diabetes~     (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the investigators develop a novel~     Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of~     Educator therapy in T1D patients.~   "
169251|NCT01350206|"~     The treatment for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT) is~     still controversial, and there is no universally agreed protocol for its treatment.~     Transarterial chemoembolization (TACE) has become the most popular palliative treatment for~     patients with unresectable HCC, and it is no longer considered as a contraindication to HCC~     with PVTT. Unfortunately, the long term outcomes are generally poor for HCC treated with~     TACE, especially for HCC with PVTT. HR remains the only therapeutic option that may still~     offer a chance of cure. With advances in surgical techniques, it has become feasible to~     remove all gross tumors, including PVTT which has extended to the main portal vein, safely by~     surgery. This study aimed to evaluate the safety and efficacy of HR as compared with TACE to~     treat patients with HCC with PVTT. The investigators also aimed to identify patient groups~     that might benefit more from either treatment with HR or TACE.~   "
169262|NCT01350063|"~     When shallow tubewells replaced highly contaminated surface water as the primary source of~     drinking water in Bangladesh in the late 20th century, contemporary studies demonstrated no~     reduction in diarrheal disease with this improvement in water source. This lack of~     improvement in transitioning to tubewells is consistent with the lack of significant health~     gains observed in intervention studies focusing on water quality improvements at the source.~     In contrast, high quality intervention studies that improve water quality at the point of use~     through treatment of water in households show a 39% reduction in diarrhea.~      The primary objective of this study is within a typical setting in rural Bangladesh where~     households use shallow tubewell water for drinking. The investigators will randomly assign~     1800 households who have a child between the ages of six months and two years to one of three~     groups. Group 1 will receive a safe water storage vessel with a lid and a narrow mouth/tap~     and Aquatabs, an effervescent water purification tablet that utilizes sodium~     dichloroisocyanurate (NaDCC) as the chlorine donor. Group 2 will only receive a safe water~     storage vessel with a lid and a narrow mouth/tap. Group 3 will receive no water intervention~     and continue their standard habits and practices. Every month a field research assistant will~     visit each participating household and collect information on the prevalence of diarrhea~     among children between the ages of six months and two years, as well as children between the~     ages of two and five years if present in the household. Diarrhea prevalence in the 48 hours~     and 7 days preceding the visit will be recorded. The investigators will compare the~     longitudinal prevalence of diarrhea between the following groups: (1) households that receive~     chlorine and storage container versus households that only receive storage container to~     assess the effect of chlorination, (2) households that only receive storage container versus~     households that receive no intervention to assess the effect of safe storage, and (3)~     households that receive chlorine and storage container versus households that receive no~     intervention to assess the combined effect of chlorination and safe storage.~      Hypothesis:~      Drinking water from shallow tubewells that are intermittently contaminated with enteric~     pathogens contributes importantly to diarrhea among children in rural Bangladesh.~   "
169252|NCT01350193|"~     All adult (over 19 years) patients undergoing sinus surgery for chronic rhinosinusitis (CRS)~     or allergic fungal sinusitis (AFS) that do not meet the exclusion criteria will be included~     in the study.~      All participants enrolled in the study will receive antibiotic (Clavulin) therapy 1-week~     pre-and post-operatively and oral steroid therapy 1-week pre-operatively and~     post-operatively.~      Randomization of patients to the Manuka Honey irrigation (treatment arm) and Saline~     irrigation (standard of care) will occur on the day of surgery.~      Participants in both study arms will undergo the standard post-operative endoscopic sinus~     surgery follow-up. This includes follow-up appointments at 6 days, 5 weeks, 3 months, and 6~     months of the post-operative period. During these appointments, the surgeon will assess the~     post-operative appearance (Philpott-Javer Sinus Rating System), number of infections, pain,~     and 1st week post-operative bleeding (only at 6 day visit).~      The Sino-Nasal Outcome Test (SNOT-22) questionnaire is to be completed by the study~     participants at 6 days, 5 weeks, and 3 months of the post-operative period. The SNOT-22 is a~     5-minute questionnaire consisting of 22 questions, which asks participants to rate their~     sinus symptoms and social/emotional consequences of their nasal disorder from no problem to~     problem as bad as it can be.~   "
169253|NCT01350180|"~     One of the biggest problems facing prostate cancer patients and their treating physicians is~     who needs to be treated and when. Common clinical and pathological parameters are useful~     (PSA, Gleason score, etc.) but do not clearly predict who will benefit from treatment and who~     will fail. Genetic markers for tumor aggressivity would be of greater value. The finding that~     the TMPRSS2-ERG gene fusion is associated with an increase risk of cancer progression is~     important. TMPRSS2 is controlled by androgen (testosterone) and ERG is part of a family of~     proteins which have a role in controlling cell growth, cell specialization and producing~     tumors. As a consequence of this gene fusion, production of the ERG protein increases in the~     presence of testosterone and could be key to the development of prostate cancer, resistance~     to treatment and poor outcome. The PTEN gene is known to have a role as a tumor suppressor.~     Its deletion is a contributing factor in the development of prostate cancers and poor~     outcome. The coexistence of the two markers could be associated with a higher risk of~     recurrence.~      To date there have been no studies regarding the presence of either of these two markers or~     their coexistence in high risk prostate cancer patients who, despite radiation therapy and~     androgen suppression, develop biochemical failure (their PSA levels rise once again).~     Patients participating in the PCS IV study (high risk prostate cancer treated with radiation~     therapy plus either 18 or 36 months of hormonal suppression) who have had biochemical failure~     or 3 years of follow-up post hormonal therapy will be approached.~      Tumor blocks from consenting patients will be collected and analyzed for the presence of the~     TMPRSS2-ERG gene fusion and the PTEN deletion at the Pathology Department of the Jewish~     General Hospital. Statistical analysis will be carried out to see whether either or both~     markers are present, whether they are associated with certain clinical and pathological high~     risk factors, and whether they can be used to predict which patients will fail treatment.~   "
169254|NCT01350167|"~     The purpose of this study is to determine whether ultrasound or CT scanning is more effective~     at detecting early liver cancer in patients with advanced liver disease.~   "
169255|NCT01350154|"~     This study is done to evaluate whether treatment with the drug sildenafil (Revatio®) can~     improve muscular, cardiac, cerebrovascular or cognitive function in patients with Beckers~     muscular dystrophy when compared to placebo (inactive medication). The study is based on the~     recent findings of an improved cardiac function in a mouse model of muscular dystrophy (Adamo~     et al 2010) and the previous findings of changed cognitive function in people with Becker~     dystrophy.~      In muscular dystrophy, the cellular protein, dystrophin is affected. During normal~     conditions, the enzyme neuronal nitric oxide synthase (nNOS), which produce nitric oxide~     (NO), is attached to dystrophin. NO is important in normal vascular function in each of~     muscle, heart and brain by stimulating production of cyclic GMP. However, in muscular~     dystrophy with dystrophin deficiency, nNOS do not have the normal cellular anchor, resulting~     in decreased NO levels and subsequent reduced cyclic GMP production. Sildenafil inhibits~     degradation of cGMP thus prolonging and increasing a cGMP response. Such effects are the~     basis for use of sildenafil in pulmonary hypertension and erectile dysfunction. Current~     hypothesis: Sildenafil restores the cyclic GMP function affected in muscular dystrophy wit~     nNOS deficiency resulting in improved muscle, cardiac, cerebrovascular and cognitive~     function.~   "
169256|NCT01350141|"~     PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this~     study to evaluate if it can lower LDL cholesterol.~   "
169257|NCT01350128|"~     The overall objective of this study is to determine an optimal dose and dosing regimen of~     PT001 MDI for further evaluation in later stage studies.~   "
169258|NCT01350115|"~     This was a phase II, double-blind, randomized, proof-of-concept, dose-ranging trial~     evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult~     patients with NBCCS. This was an exploratory study designed to demonstrate preliminary~     efficacy of LDE225 in this indication. This study included a Screening period of~     approximately 4 weeks, treatment period duration of 12 weeks with initial follow-up of~     approximately 6-8 weeks followed by a long-term follow-up period.~   "
169259|NCT01350102|"~     The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic~     wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health~     Care Corp., Clearwater, FL) and Bacitracin, with and without vitamin C supplementation, will~     be done to evaluate impact on time to wound closure.~   "
169260|NCT01350089|"~     The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks~     has an effect on perceived alcohol intoxication.~   "
169261|NCT01350076|"~     The objectives of this study are 1) to investigate the influence of different fluid regimen~     (Liberal regimen versus Goal directed therapy regimen) on postoperative outcome such as~     weight gain, delayed gut function recovery, pneumonia and 2) to ascertain the reliability of~     USCOM monitoring using serum lactate and base deficit as control parameters.~   "
169263|NCT01350050|"~     Topical Pharyngeal anesthesia (TPA) is widely used during upper endoscopy. Articaine is local~     anaesthetic that have not been previously evaluated in pharyngeal anesthesia for upper~     endoscopy. The aim of this study was to compare pharyngeal anesthesia with 4% articaine to~     placebo (Na0,9%) during gastroscopy in terms of benefit on patients` and endoscopists`~     satisfaction.~   "
169264|NCT01350037|"~     Self-administration of propofol and opioid mixture by the patient him- or herself~     (patient-controlled sedation, PCS) could be successful alternative to the~     anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography~     (ERCP). However, it is not known which opioid would be the most suitable for PCS. The aim of~     this double-blind study was to compare remifentanil and alfentanil in PCS during ERCP.~   "
169352|NCT01348893|"~     The purpose of this preliminary study is to evaluate the effects of a yoga-based program on~     high school students' psychological health. Results will be used to generate specific~     hypotheses of how yoga may improve adolescent mental health.~   "
169265|NCT01350024|"~     Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a~     posterior approach. Patients who undergo this procedure are often given local anesthesia to~     alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal~     nerve block or subconjunctival injection combined with sedation in most cases. Both~     techniques are currently acceptable options for local anesthesia, however postoperative pain~     has not been systematically evaluated between these two techniques.~      The investigators aim to compare intra-operative and postoperative pain with these two~     techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will~     be randomized to receive local anesthesia via frontal nerve block or via subconjunctival~     injection. In addition, the investigators will measure the surgical outcomes of the ptosis~     surgery with standard measures.~   "
169266|NCT01350011|"~     Drug addiction treatment patients, including those in treatment for opioid dependence, have a~     high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates~     an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid~     treatment patients, those in buprenorphine maintenance. The specific aims of the study are to~     test the efficacy and the cost effectiveness of the IS.~      A secondary aim is obtain preliminary data about differences in use of non-nicotinic drugs~     between participants who achieve abstinence from cigarettes during the study, and those who~     do not.~   "
169267|NCT01349998|"~     The purpose of this study is to examine the long-term safety of treating recurrent episodes~     of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or~     tinea cruris for 7 days for each recurrence with Product 33525.~   "
169268|NCT01349985|"~     Talaria, Inc., has designed an adherence tracking and enhancement system, called AGATE, which~     uses the text messaging and internet capabilities of modern cellular phones to address the~     problem of medication adherence in clinical care and clinical trial contexts. This trial will~     evaluate whether AGATE improves medication adherence in the context of a pharmacotherapy~     trial of naltrexone to treat problem drinking. All participants will be treatment-seeking~     problem drinkers who will receive naltrexone and medication monitoring over 8 weeks.~   "
169269|NCT01349972|"~     This randomized phase II trial is studying how alvocidib, cytarabine, and mitoxantrone~     hydrochloride work compared to cytarabine and daunorubicin hydrochloride in treating patients~     with newly diagnosed acute myeloid leukemia. Alvocidib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     cytarabine, mitoxantrone hydrochloride, and daunorubicin hydrochloride work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. It is not yet known whether giving alvocidib, cytarabine, and mitoxantrone~     hydrochloride is more effective than giving cytarabine and daunorubicin hydrochloride in~     treating patients with acute myeloid leukemia.~   "
169270|NCT01349959|"~     This phase II trial studies how well giving azacitidine and entinostat work in treating~     patients with advanced breast cancer. Drugs used in chemotherapy, such as azacitidine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill~     more tumor cells.~   "
169271|NCT01349946|"~     Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution Study 2 (DEFUSE~     2) is a multi-center pilot study to determine if cerebral perfusion imaging can help identify~     which patients, who are ineligible for intravenous tissue plasminogen activator (iv tPA)~     therapy or have failed iv tPA therapy, are most likely to benefit from an endovascular clot~     removal procedure.~   "
169272|NCT01349933|"~     This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with~     recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
169273|NCT01349920|"~     This study will evaluate biomarkers that reflect changes in gut mucosal status during therapy~     with infliximab and determine whether changes in the levels of the selected biomarkers can be~     used to predict endoscopically assessed gut mucosal status changes.~   "
169274|NCT01349907|"~     This study will investigate the safety and tolerability of a flexible dosing regimen of~     asenapine for the long-term treatment of manic or mixed episodes associated with bipolar~     disorder I in children and adolescents who completed study P06107.~   "
169275|NCT01349894|"~     The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System~     for the treatment of skin cancer excision sites and split thickness skin grafts (STSG). The~     secondary purpose will be to compare the prospective patients to retrospectively treated skin~     cancer excision sites and STSGs to further evaluate efficacy and safety.~   "
169276|NCT01349881|"~     The investigators hypothesize that the combination of eflornithine and sulindac will be~     effective in reducing a three-year event rate of adenomas and second primary colorectal~     cancers in patients previously treated for Stages 0 through III colon cancer.~   "
169277|NCT01349868|"~     The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI~     compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic~     obstructive pulmonary disease (COPD).~   "
169278|NCT01349855|"~     Primary Objective:~      To assess the safety and tolerability of two dose levels of a new insulin glargine~     formulation in a once-daily multiple dosing regimen~      Secondary Objective:~      To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new~     insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen~   "
169279|NCT01349842|"~     Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of~     chemotherapy for metastatic breast cancer.~   "
169280|NCT01349829|"~     This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides~     protection that is non-inferior to the protection afforded by vaccination with Havrix 720~     Junior.~   "
169281|NCT01349816|"~     The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its~     individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic~     obstructive pulmonary disease (COPD).~   "
169282|NCT01349803|"~     This study is primarily a safety study. The primary and secondary endpoints are based on~     24-hour Holter monitor assessments obtained on Day 14 relative to baseline.~   "
169285|NCT01349764|"~     When Vitamin D replacement is initiated in patients with history of urolithiasis, there will~     be higher incidence of hypercalciuria but with careful follow-up of these patients,~     hypercalciuria could be appropriately managed with thiazide diuretics so that the risk of~     newly diagnosed renal stones will be equivalent to control groups without Vitamin D~     replacements.the purpose of the study is to determine the effect of vitamin D replacement in~     patients with previous history of urolithiasis presenting to a tertiary stone clinic in terms~     of changes in 24-hour urine collection parameters and to evaluate the lithogenic effect of~     vitamin D replacement in terms of development of urolithiasis. Eighty-six eligible patients~     will be included in terms of having suboptimal vitamin D with history of calcareous~     urolithiasis and urinary calcium excretion <7.5 mmol/day. Patients will be randomly divided~     into 2 equal groups depending on whether they will receive vitamin D replacement with~     follow-up at 3, 6, 12, & 24 months.~   "
169286|NCT01349751|"~     The authors would like to investigate the blocking characteristics, surgical quality and side~     effects of intrathecal levobupivacaine whether there are any differences between the~     hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block~     level than the urological surgeries.~   "
169287|NCT01349738|"~     The goal of this research program is to understand the natural history of asymptomatic~     bacteriuria in the renal transplant patients, to determine if screening for asymptomatic~     bacteriuria and identification of key host characteristics and virulence factors present on~     uropathogenic bacteria identifies a sub-population of patients with asymptomatic bacteriuria~     that are at risk to develop symptomatic urinary tract infection. Ultimately, the knowledge~     obtained from this study will prevent inappropriate antibiotic use and may identify whether~     certain bacterial isolates predispose to renal allograft injury. We will test the hypothesis~     that (i) asymptomatic bacteriuria is common in the renal allograft recipient and (ii) that~     symptomatic urinary tract infection and renal allograft dysfunction do not occur unless key~     host susceptibility factors and uropathogenic bacterial virulence factors are present.~   "
169288|NCT01349725|"~     This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of~     investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects~     from the United States will be enrolled in this study.~   "
169289|NCT01349712|"~     The purpose of this study is to measure prothrombin time (PT) on an experimental device and a~     commercially available device on persons receiving coumadin (warfarin)treatment.~   "
169290|NCT01349699|"~     Iron affects immunity. However, the exact effect of iron on the innate immune response is not~     known. Animal data suggest that iron administration induced oxidative stress which enhances~     the innate immune response, whereas iron chelation has the opposite effect. The investigators~     tested the hypothesis that administration of iron sucrose 1.25 mg/kg augments the innate~     immune response, and iron chelation by deferasirox 30 mg/kg attenuates the innate immune~     response during human experimental endotoxemia.~   "
169291|NCT01349686|"~     Fasting during labour is a usual conduct in many hospitals around the world (due to the~     theorical risk of bronchoaspiration). There is little evidence supporting this conclusion.~     Besides, there are several studies that suggest that food intake during labour can be~     associated with shorter labours and a lower cesarean rate. The aim of the investigators study~     is to show if the oral intake of fluids during labour can reduce the first stage of labour~     with minimum risk to the patient.~   "
169292|NCT01349673|"~     The purpose of this study is to evaluate safety and tolerability of cyclically dosed rectal~     budesonide foam in subjects with active ulcerative proctitis (UP) or ulcerative~     proctosigmoiditis (UPS).~   "
169293|NCT01349660|"~     In this phase I/II study,investigators are evaluating the feasibility and efficacy of the~     combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of~     patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120~     dose to be administered with a standard dose of bevacizumab will be determined in patients~     with refractory solid tumors. Although it is unlikely that the concurrent administration of~     bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will~     be performed on all patients treated during the Phase II portion of the study. Assuming this~     combination is feasible, the Phase II portion of the study will proceed, using the doses~     determined in the Phase I portion. In the phase II portion, eligible patients will be limited~     to those with recurrent/progressive GBM following 1st line combined modality therapy.~   "
169294|NCT01349647|"~     Even when small cell lung cancer responds well to treatment with chemotherapy, it has a~     tendency to grow back and to spread. The investigators are interested in testing new~     therapies aimed at decreasing this risk. This study tests a vaccine, which is a substance~     injected under the skin which can cause an immune response. The hope is that the body will~     make antibodies to the vaccine which will also react against the cancer. The vaccine is~     specific for small cell lung cancer. It combines several components (small cell lung cancer~     targets) that have been tested individually in patients with small cell lung cancer or other~     cancers (GD2, GD3, Globo H, Fucosyl GM1 and N-propionylated polysialic acid). Two other~     substances (KLH and OPT-821) are added which boost the immune system.~      This study will have two groups of patients. The first group will receive the vaccines along~     with one cycle of chemotherapy. The second group will receive the vaccines without~     chemotherapy.~   "
169305|NCT01349504|"~     Hypothesis:~      Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory~     Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in~     patients with IBD. These factors can be identified using qualitative testing in order to~     develop a validated instrument to measure the adherence profile of an individual patient,~     and design appropriate behavioral interventions to reduce non-adherence.~      Objectives:~      To test a novel interview instrument that determines the medication adherence profile of~     patients with IBD prescribed mesalamine by correlating with objective measures of adherence~   "
169306|NCT01349491|"~     The investigators hypothesize that ranolazine would decrease the incidence of recurrence of~     Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with~     persistent AF who are candidates for electrical cardioversion will be randomized to either~     placebo or ranolazine after successful electrical cardioversion.~   "
169363|NCT01348737|"~     The purpose of the study is to assess the safety, tolerability and blood concentration of~     AZD3839 following oral administration of single doses in healthy men and women of~     non-childbearing potential~   "
169295|NCT01349634|"~     Many school children in Ethiopia and their mothers are known to be iodine deficient.~     Prevalence in the Amhara region is around 29%. Micronutrient Initiative, a development~     organization based in Ottawa, plans to help iodize the salt by providing iodization machines~     and iodine to the salt producers in Lake Afdira where salt is produced and distributed to the~     population of Ethiopia. Although it is generally assumed that iodine is important for~     cognitive development, very few studies examining the effects of iodized salt have been~     conducted. Studies using a single dose of iodine capsules with children 6 to 12 years showed~     mixed outcomes with approximately 25% yielding positive outcomes for the intervention~     children. Sixty districts in Amhara will be randomly selected and randomly assigned so that~     half receive early delivery of iodized salt. Approximately 6200 mothers and their children~     6-, 18-, or 60-months old will be recruited from 1-2 villages in each of the 60 districts,~     with the help of government-paid Health Extension Workers, for a 12-mo longitudinal study~     starting in May 2011, prior to the introduction of iodized salt. These same mothers and~     children will be visited 12 months later for repeated measures. Measures include nutritional~     status such as height and hemoglobin, along with iodine sufficiency (e.g., goitre, urinary~     iodine, thyroglobulin), and child development (Bayley Scales of Infant and Toddler~     Development III, Wechsler Preschool and Primary School Intelligence test for older children).~     Comparisons will be made within and between groups to determine whether iodized salt has an~     effect on children's mental development.~   "
169296|NCT01349621|"~     This is a prospective study to compare unpolarized (conventional) to polarized light~     colposcopy. Subjects will be asked to participate in the study when they arrive for their~     prescheduled colposcopic examination. The study doctor will use a conventional or standard~     colposcope to perform the examination. His/her impression of the exam will be noted and if~     necessary a biopsy specimen will be obtained. The study doctor will then perform a colposcopy~     using a polarized light. His/her impression of the exam will be noted and a biopsy specimen~     will be obtained if necessary.~      This study is designed to test the hypothesis that polarized light colposcopy is more~     sensitive and more specific than standard, un-polarized light colposcopy.~   "
169297|NCT01349608|"~     This study is designed to explore a new approach to help people with chronic obstructive~     pulmonary disease (COPD) become more physically active. Through weekly telephone sessions~     with a health coach utilizing motivational interviewing, participants will be empowered to~     set goals for increased physical activity (emphasis on walking). The objective of the study~     is to determine if telephone-based health coaching is a reasonable and effective way to~     increase physical activity, as measured by a gold-standard activity monitor, in people with~     COPD.~   "
169298|NCT01349595|"~     The purpose of this study is to see if treating patients who have high levels of donor~     specific alloantibodies post-transplant with bortezomib might prevent the development of~     transplant glomerulopathy and preserve allograft function.~   "
169299|NCT01349582|"~     Flow diverters are a recent addition to the range of endovascular devices now available for~     the treatment of intracranial aneurysms. The FIAT trial aims at comparing flow diversion to~     best standard treatment in the context of a randomised controlled trial. Best standard~     treatment may include any of the following and will be left to the treating physician to~     decide : 1) conservative management; 2) coiling with or without high porosity stenting; 3)~     parent vessel occlusion with or without bypass; 4) surgical clipping. If the only treatment~     alternative is deemed to be flow diversion for compassionate use, then randomisation will not~     be carried out, but patient will enter a registry and her data recorded according to same~     schedule as randomised patients.~      The primary hypothesis is that flow diversion can be performed with an acceptable immediate~     complication rate, defined as less than 15% morbidity and mortality, AND increase the number~     of patients experiencing successful therapy, defined as complete or near complete occlusion~     of the aneurysm from 75 to 90%, relative to best standard treatment.~   "
169300|NCT01349569|"~     This research is being done to find out if the investigators can improve outcomes for~     multiple myeloma patients by giving a myeloma vaccine to patients who are already on~     lenalidomide (Revlimid) and in a near complete remission.~   "
169301|NCT01349556|"~     This research is being done to study whether using of topical tretinoin can help prevent the~     common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I)~     medications such ascetuximab or erlotinib.~      Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their~     face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and~     topical or oral antibiotics. However, there has not yet been a study looking at a way to~     prevent this common side effect from occurring, and topical tretinoin may be useful in~     reducing the rash.~      Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the~     treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing~     rashes associated with EGFR-I's.~   "
169302|NCT01349543|"~     The aim of this study is to understand the immune response (how the body fights infection) to~     Respiratory Syncytial Virus (RSV). This virus usually causes a simple 'common cold' illness~     in healthy adults, but can cause wheezing and lung problems in young infants and the elderly.~     The investigators want to understand why this is, in order to develop vaccines and~     treatments.~      Participants will include 30-40 healthy adults age 18-55 years. Study procedures will include~     brief medical exams, breathing tests, a diary of symptoms, blood tests, samples of fluid~     (lavage) and cells from the nose, throat and lungs. All participants will receive the virus~     via drops in the nose. The duration of the study for all subjects will be 6 weeks.~   "
169303|NCT01349530|"~     Main objective: To evaluate the impact of CREATIF (an anticoagulation clinic in Ile de~     France) on monitoring and management of patients treated with VKAs compared with usual~     primary care.~      Study hypothesis: The investigators suppose that patients will have a better quality of~     anticoagulation when they are managed by CREATIF than by their usual General Physicians (GP)~   "
169304|NCT01349517|"~     The purpose of this multi-center prospective cohort study is to study the health-related~     quality of life (HRQL) together with other outcomes of patients with esophageal cancer after~     surgery in China.~   "
169307|NCT01349478|"~     The purpose of this study is to determine whether a three times per week, 2 month robotic~     assisted treadmill gait training program, will beneficially affect the fitness, physical and~     psychological well-being, and the vascular and metabolic cardiovascular risk factors in~     individuals with complete motor Spinal Cord Injury (SCI).~   "
169309|NCT01349452|"~     Ganciclovir ophthalmic gel delivers multiple advantages in the treatment and prophylaxis of~     herpetic keratitis and shows potential for effectiveness against other viral ocular~     infections. The majority of adenoviral conjunctivitis will resolve without damaging vision,~     however, the investigators have no way to determine which cases will progress to ocular~     complications such as corneal infiltrates and pseudomembranes. Our purpose is to evaluate the~     efficacy of the Ganciclovir gel 0.15% in preventing ocular complications after adenoviral~     conjunctivitis.~   "
169310|NCT01349439|"~     The purpose of this study is to test whether propranolol is capable of reducing subsequent~     physiological trauma-related conditioned responses, as well as self-reported post-traumatic~     stress disorder (PTSD) symptoms.~   "
169311|NCT01349426|"~     Surgical staplers have become standard for ligation, division, resection, anastomosis and~     closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for~     pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition,~     closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally~     safe and efficacious, staplers and staple loads are expensive, and can result in micro air~     leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive~     alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat~     generated via bi-polar radiofrequency energy and precise jaw pressure to denature the~     collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator~     and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer~     improved performance in terms of tissue sticking due to an improved sealing algorithm, and to~     the jaw configuration of the Impact. The study main objective is to compare the quality of~     parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with~     LigaSure.~   "
169312|NCT01349413|"~     Background:~      Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of~     functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the~     first line treatment for functional dyspepsia. However, the results on effectiveness of PPI~     are conflicting and it has been suggested that PPI is only effective for acid-related~     symptoms.~      The investigators plan to use a wireless pH monitoring system positioned at the junction of~     esophagus and stomach to evaluate the chronological relationship between acid exposure at~     this region and symptoms of dyspepsia as well as its impact on the efficacy of acid~     suppressive therapy in treatment of functional dyspepsia.~      Indication:~      Functional dyspepsia patients~      Study center(s):~      Prince of Wales Hospital, Hong Kong~      Aims:~        1. To evaluate the chronological relationship between acid exposure at squamo-columnar~          junction (SCJ) and dyspeptic symptom in different subtypes of functional dyspepsia~        2. To evaluate the relationship between acid exposure at squamo-columnar junction and~          dyspeptic symptom response to PPI~        3. To compare the efficacy of PPI and placebo in treating functional dyspepsia patients~      Study medication:~      Esomeprazole 20mg vs Placebo o.d.~      Study design:~      Double-blind randomized placebo-controlled trial~      Number of subjects: 130~      Patient population:~      Functional dyspepsia patients without concomitant gastroesophageal reflux disease (GERD)~      Duration of study:~      1 June 2010 - 30 May 2012~      Primary variable(s):~      Proportion of patients who report positive response to adequate relief of dyspeptic symptoms~     at week 8~      Secondary variable(s):~      Dyspeptic symptom scores, symptom association probability of dyspeptic symptoms in relation~     to esophageal pH of less than 4 as measured at 1 cm above SCJ.~      Number of visits: 2~      Hypothesis:~      Increased acid exposure at SCJ contributes to dyspeptic symptom and predicts treatment~     response to PPI in FD patients without concomitant GERD~   "
169313|NCT01349400|"~     Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic~     incisional hernias in terms of pain and discomfort during normal activities.~   "
169314|NCT01349387|"~     Main objective : Show that treatment with metformin in patients with type 2 diabetes has an~     effect on alternative splicing of the insulin receptor.~      Secondary objective : demonstrate that the effect on the ratio A/isoform B isoform with~     discontinuation of treatment with metformin can be réversé by the resumption of metformin~     treatment.~   "
169315|NCT01349374|"~     The main objective of this study is the Obtention of skin micro-samples collected from~     healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to~     obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.~   "
169316|NCT01349361|"~     Photodynamic Therapy (PDT) is an effective treatment of basal cell carcinomas (BCC) however~     the inconvenience of clinic attendance and discomfort during therapy are significant~     drawbacks. The objective of this study is to evaluate the effect of daylight-mediated PDT of~     BCC.~   "
169317|NCT01349348|"~     To evaluate the efficacy and safety of Tolvaptan 7.5mg and 15mg in treatment of patients with~     cirrhosis ascites who fail to response adequately to treatment with common diuretics.~   "
169318|NCT01349335|"~     To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis~     with ascites and exploring the dosage-effect relations of the drug.~   "
169319|NCT01349322|"~     RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as~     effective as standard per daily radiation therapy in treating breast cancer.~      PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per~     daily radiation therapy with concomitant boost works compared to standard per daily radiation~     therapy with a sequential boost in treating patients with early-stage breast cancer that was~     removed by surgery.~   "
169320|NCT01349309|"~     The purpose of this study is to find out if doing prophylactic or preventative swallowing~     exercises from the start of cancer treatment can improve the ability to swallow when the~     treatment is completed and beyond.~   "
169321|NCT01349296|"~     BIBF1120 and RAD001 in solid tumors~   "
169322|NCT01349283|"~     The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to~     the comparator vaccine both at impeding hepatitis B transmission from mothers positive for~     chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in~     children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion~     of the immunization schedule.~   "
169323|NCT01349270|"~     Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a challenge because~     disease may generate important disability in patients including young adults. Randomized~     trials showed that corticosteroids, plasma exchanges and intravenous immunoglobulin (IVIg)~     can reduce impairment on a short term period but the treatment of a chronic disease doesn't~     agree with it. Corticosteroids and IVIg are the first line CIDP treatments. No study permits~     to demonstrate the superiority of one treatment to the other. Long term adverse effects of~     corticosteroids and IVIg cost are the respective limitation of their use. The investigators~     scheduled to recruit 40 CIDP patients in 23 French centres to receive either 0,8mg/kg/day of~     prednisone progressively tapered over 6 months or a monthly 2g/kg cure of IVIg during 6~     months. Patients will be followed during 6 months after the treatment.~   "
169364|NCT01348724|"~     Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a~     Single-Dose Oral Administration.~   "
169324|NCT01349257|"~     The aim of this clinical study is to compare the lung exposure of the contents of the trial~     drug after administration of the fixed combination between beclomethasone and formoterol~     delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and~     formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device.~     To determine lung exposure, the treatments are administered with charcoal block.~   "
169325|NCT01349244|"~     The purpose of this study is to determine the overall sensitivity and specificity of~     hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to~     hydronephrosis found by CT.~   "
169326|NCT01349231|"~     Roughly one-third of patients with obsessive-compulsive disorder (OCD) do not experience~     significant clinical benefit from first-line interventions such as pharmacotherapy with~     selective serotonin reuptake inhibitors (SSRI) or cognitive behavioral therapy (CBT).~     Furthermore, OCD patients typically experience the full treatment benefits of first-line~     interventions only after a time-lag of two to three months. Inadequate symptom relief and~     delay of symptom relief from first-line treatments are sources of substantial morbidity and~     decreased quality of life in OCD patients. Converging lines of evidence from neuroimaging,~     genetic and pharmacological studies support the importance of glutamate abnormalities in the~     pathogenesis of OCD.~      The investigators are conducting an open, uncontrolled study of ketamine in~     treatment-refractory OCD. Ketamine is a potent antagonist of the N-methyl-D-aspartate (NMDA)~     receptor and has been demonstrated to have rapid anti-depressant effects in patients with~     Major Depressive Disorder. The investigators have additionally provided evidence for rapid~     improvement of comorbid OCD and trichotillomania after ketamine infusion in a depressed~     woman.~      Failure of symptom relief and delay of symptom relief from first-line treatments are a source~     of substantial morbidity and decreased quality of life in OCD patients. Ketamine represents~     the possibility to provide rapid symptom relief to OCD patients and may provide the mechanism~     for future drug development to treat OCD more rapidly and effectively.~   "
169327|NCT01349218|"~     The purpose of this study is to find out whether there is a correlation (link) between the~     level of potassium in blood samples drawn from a vein and those drawn from a heel stick in~     infants scheduled for elective surgery.~   "
169328|NCT01349205|"~     The aim of this study is to evaluate whether a smaller dose of caffeine sodium benzoate 10~     mg/kg IV is as effective as 20 mg/kg IV in decreasing the number of children who develop post~     extubation adverse upper airway respiratory events compared to placebo.~   "
169329|NCT01349192|"~     Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant~     Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in~     2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing~     this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung~     infections in CF it is unclear how the onset of MRSA should be approached. This randomized,~     controlled, interventional study seeks to determine if an early eradication protocol is~     effective for eradication of MRSA and will provide an opportunity to obtain data regarding~     early clinical impact of new isolation of MRSA.~      Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory~     culture on a routine clinic visit.~      Procedures (methods): Randomized, open-label, multi-center study comparing use of an~     eradication protocol to an observational group who receives the current standard of care i.e.~     treatment for MRSA only with pulmonary exacerbations.~   "
169330|NCT01349179|"~     The couple of friction metal-polyethylene is regarded as the couple of reference in spite of~     the osteolysis induced by the wear of the polyethylene which remains the independent factor~     of long-term failure. This is all the more true as the patients are young, thus justifying~     the recourse to alternate couples of friction. The Metasul® couple was introduced on the~     French market under its current form in 1995 (year of its marking EC). The use of a couple of~     friction metal-metal (MM) is justified because it would be likely to improve longevity of the~     total arthroplasties of the active subjects by the reduction in osteolysis related to the~     wear of polyethylene. Various studies highlight evolutions different according to the types~     of fixing acetabular; favourable results of the not cemented cups contrasting with unsealings~     and the evolutionary edgings of the Metasul® cups cemented of or the cups of cemented Weber~     type.~   "
169331|NCT01349166|"~     The incidence of type 2 diabetes is increasing worldwide. Because of cardiovascular morbidity~     and mortality associated with type 2 diabetes, it is imperative to propose methods of~     prevention and this in early stage of abnormal glucose metabolism.~      This study will assess the beneficial effects of physical activity (acute and chronic~     effects) (the subjects being their own controls) on cardiometabolic and inflammatory~     biomarkers in 3 conditions : unstimulated (fasting and resting conditions) and stimulated~     conditions: postprandial response to a standardized meal preceded or not by an exercise bout.~      The investigators hypothesized that an acute bout of exercise will decrease the postprandial~     inflammatory response to a standardized meal and that this effect of exercise will be~     increased after 3 months of exercise training.~   "
169332|NCT01349153|"~     The purpose of this study is to determine the feasibility and efficacy of a behavioral~     intervention, delivered through an existing social networking website (Facebook), on physical~     activity (moderate-intensity minutes per week) among young adult cancer survivors compared to~     a self-help education condition. For this research study, investigators will conduct a~     12-week randomized trial. After a baseline survey, weekly messages, a pedometer, goal-setting~     tool, physical activity log and discussion prompts will be delivered to the intervention~     group. Comparison group participants will receive links to websites with self-help education~     materials. After 12 weeks, a follow-up survey will be given to both groups. Changes in~     physical activity, quality of life and psychosocial factors will be examined. The~     investigators hypothesize that those receiving the intervention will have improved physical~     activity behaviors at 12-week follow-up relative to those in the comparison group.~   "
169333|NCT01349140|"~     EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic~     (numbing medicine) that is designed to be longer acting than the currently-available local~     anesthetics. The purpose of this study is to determine the effect on thigh muscle strength~     and skin sensitivity of various doses of EXPAREL when placed next to the nerve that goes to~     the thigh.~   "
169945|NCT01341119|"~     To study clinical features, prognostic factors and treatment outcome and to develop a~     possible prognostic index in skin/soft tissue primary NK/T cell lymphoma patients.~   "
169334|NCT01349127|"~     This is a randomized, placebo-controlled trial of vitamin D supplementation with 20mcg~     cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to~     assess vitamin D requirements in lactating women and to ascertain whether vitamin D~     supplementation at levels sufficient to achieve defined thresholds of maternal serum~     25-hydroxyvitamin D will increase the vitamin D content of maternal milk. The study will also~     report serum 25-hydroxyvitamin D in maternal-cord dyads over a 12-month period and describe~     the relationship between them. Information on maternal iPTH levels, anthropometry, diet and~     sun exposure will also be reported.~   "
169335|NCT01349114|"~     The study will evaluate the effects of the direct renin inhibitor, aliskiren, on~     flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic~     patients with pre-hypertension or Stage 1 hypertension.~   "
169336|NCT01349101|"~     It is hypothesized that engraftment when administering cyclophosphamide post the stem cell~     infusion will increase, the incidence of graft versus host disease (GVHD) and day 100~     mortality will decrease, and the use of cyclophosphamide post stem cell infusion with~     alternative donors will be as safe and as effective as traditional matched transplants.~   "
169337|NCT01349088|"~     In 2008 there were more than 40,000 deaths caused by metastatic breast cancer in the United~     States. The development of new treatment strategies is essential to improve outcome for~     patients with metastatic breast cancer~      There is significant preclinical and clinical evidence indicating that creating new blood~     vessels (neoangiogenesis) to provide nutrients to solid tumors, including breast cancer,~     provides the necessary conditions to allow tumor growth. Vascular endothelial growth factor~     (VEGF) is one of the important molecules regulating new blood vessel formations and~     subsequent invasion and metastases. As a result, agents that inhibit VEGF are of substantial~     interest for the treatment of advanced diseases.~      This study will further the body of research of motesanib which has been shown in preclinical~     pharmacology and clinical pharmacology studies to be a potent, orally bioavailable~     multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively~     targeting all known VEGF, platelet-derived growth factor (PDGF), and Kit receptors.~   "
169338|NCT01349075|"~     TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has~     been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere),~     it can be injected into the liver through a blood vessel. This allows a large local dose of~     radiation to be delivered to the tumor with less risk of toxic effects from radiation to~     other parts of the body or to healthy liver tissue.~   "
169339|NCT01349062|"~     This research work is important for the cure/control of HIV infection. The study is intended~     to confirm the efficacy of Kallunk Oxide (Immunotherapy) molecules in the Treatment of HIV~     infection. The study will investigate the T- Lymphocytes (immune) response to HIV in order to~     boost the body's natural immune ability against infection. The basic study is directly~     inhibit a protein's increased functions, not only in the CD4+T cell but also CD3+ and CD8+ T~     cells and the CD45+. cells.~      The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and~     lifestyle can be more easily studied.~   "
169340|NCT01349049|"~     The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels~     (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed~     or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be~     considered based on safety and efficacy observations.~   "
169341|NCT01349036|"~     The objective of this study is to evaluate the response of subjects with recurrent~     glioblastoma to continuous therapy of PLX3397.~   "
169342|NCT01349023|"~     Pre-portioned entrées are commonly consumed to help control portion size and limit energy~     intake. Few studies, however, have investigated the influence of the characteristics of~     pre-portioned entrées on energy intake. This study investigates how the characteristics of~     solid pre-portioned entrées, specifically, variations in their energy content and energy~     density influence energy intake over a day. The investigators hypothesize that reducing the~     energy content and energy density of compulsory entrées will act independently and add~     together to reduce daily energy intake.~   "
169343|NCT01349010|"~     The purpose of this study is to evaluate the efficacy and safety of imported Probucol in~     hyperlipidemia patients.~   "
169344|NCT01348997|"~     This study will develop and examine the effectiveness of an intervention that utilizes~     technology to improve cancer survivors' access to mental health care and increase their~     ability to manage the stressors involved in cancer survivorship. The intervention, referred~     to as Project Onward, uses an interactive website and an online social network. The purpose~     of this study is to pilot a novel intervention that can reduce costs, examine methods to~     improve adherence to internet based treatment and overcome numerous barriers to treatment for~     mental health concerns.~   "
169345|NCT01348984|"~     The purpose of this study is to determine whether transdermal fentanyl patch~   "
169346|NCT01348971|"~     The purpose of this study is to determine whether oral sodium nitrate administration prior to~     coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition,~     plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.~   "
169347|NCT01348958|"~     This study is to compare scans of the knee performed using new software designed specifically~     to look at the knee joint with those performed using approved software designed for scans of~     the hip.~   "
169348|NCT01348945|"~     Anterior cruciate ligament (ACL) is known to serve a number of functions in the knee joint.~     Besides providing mechanical stability, it also contributes to proprioceptive function.~     Numerous studies reported ACL is rich in mechanoreceptors contribute in proprioceptive~     function. ACL augmentation, or selective ACL bundle (AM, anteromedial or PL, posterolateral)~     reconstruction, a relatively new technique for partial torn ACL, preserves and augments the~     ACL remnant aiming at maintaining or facilitating proprioception, is now gaining its~     popularity. Preserving ACL stump is also reported to have merits in providing better~     mechanical protection and promoting revascularization to the newly reconstructed graft.~      In local setting, stump preserving ACL surgery is the usual practice in handling partial ACL~     tear. With the background of the surgery's potential benefits in restoration of knee~     function, a single-blinded, comparative study on the difference in proprioception, postural~     stability and clinical outcome between stump preserving ACL surgery and reconstruction is~     conducted.~   "
169353|NCT01348880|"~     The study will be conducted as a multi-center, randomized, double-blinded, placebo~     controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating~     Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT~     during Period 1 or 2; the blinded matching placebo will be given as a single administration~     during the opposing period. The random code will determine the order of active drug~     (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be~     recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non~     investigational drug product (vasodilator), Procardia XL, will be background treatment for~     hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for~     at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the~     requirement that all subjects will be male, are between the ages of 65 and 80 years, and will~     have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size~     will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this~     analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the~     ages of 70 and 80 years. The total duration of the study will be approximately one year from~     first subject treated to last subject treated, including replacement of any subjects who fail~     to complete both periods of crossover dosing.~   "
169354|NCT01348867|"~     The investigators hypothesize a diabetes nurse consultant led team with particular emphasis~     on compliance and attainment of treatment targets in Type 2 diabetic patients will achieve~     metabolic control, improve clinical outcomes and levels of self efficacy compared to usual~     clinic-based care.~   "
169355|NCT01348854|"~     To determine if arcuate incisions performed with the iFS femtosecond laser are safe and~     effective in reducing corneal astigmatism.~   "
169356|NCT01348841|"~     Wounds that are slow to heal (chronic) may be managed in different ways. In Ontario, care in~     the community for most of these is coordinated by the local Community Care Access Centre~     (CCAC). One or more health professionals might deliver treatment, individually or as part of~     a wound care team, with different members having different kinds of training~     (interdisciplinary team), which may or may not include wound care. Community treatment by~     interdisciplinary teams has been shown to be more effective and cost-effective for some~     long-standing health problems, but further scientific evidence is needed to determine if this~     is also true for chronic wounds.~      This study compares the usual way chronic wounds are being managed in the community with a~     so-called intermediate care approach. In this study, intermediate care will involve health~     service providers following certain agreed-upon steps (evidence-based best practice) from~     first contact with the client through assessment, treatment, and on to referral to a hospital~     specialty wound care team, if needed.~   "
169357|NCT01348828|"~     The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated~     Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.~   "
169358|NCT01348802|"~     Pain is a problem for many Canadians. Unfortunately, many doctors, nurses, therapists, and~     psychologists have trouble keeping up to date and applying the latest research that might~     help patients suffering with pain. This study will determine whether sending alerts about new~     pain research directly to these health professionals, and providing them with access to~     accumulated alerts, will help. The study will compare knowledge and decisions made by health~     professionals about managing pain problems. The investigators will compare physicians,~     nurses, rehab therapists and psychologists at the beginning of the study and after having~     access to different ways to find out about new pain research. One group will receive alerts~     about new pain studies that have been found to be high quality and relevant to patient care,~     and will be able to search the alerts database. The other group will be able to find the same~     studies,but must go to the database of research studies to locate them. The investigators~     will include 670 doctors, nurses, rehab therapists, and psychologists in this study. A~     process like tossing a coin will determine which way they are able to get pain research~     information. The investigators will monitor how much information they access and how they~     apply it to managing pain problems. The investigators expect that reminding health care~     providers about new research findings directly will help them, since difficulty finding~     studies and lack of time prevent them from using the latest research. The investigators~     expect that reminders about the latest research will help them make better decisions about~     caring for patients' pain.~   "
169359|NCT01348789|"~     To measure the safety of hair removal device when used frequently.~   "
169360|NCT01348776|"~     The purpose of this study is to determine efficiency of Hair2Go device for short-term and~     long-term removal of unwanted hair adjunctive to shaving using a before-after study design.~   "
169361|NCT01348763|"~     This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects~     currently attending for HIV care at St. Mary's Hospital, London will be eligible.~      The study will describe the steady state pharmacokinetic parameters and short term safety of~     maraviroc/darunavir/ritonavir dosed at 150/800/100 mg once daily with and without~     tenofovir/emtricitabine 245/200 mg once daily in HIV-1 infected subjects.~      Fifteen HIV-1 infected subjects will be recruited. Eligible subjects will currently be~     receiving antiretroviral therapy comprising:~        -  tenofovir/emtricitabine 245/200 mg daily plus~        -  darunavir/ritonavir 800/100 mg daily~      On day 1, subjects will modify their current antiretroviral therapy to the following:~        -  tenofovir/emtricitabine 245/200 mg daily plus~        -  darunavir/ritonavir 800/100 mg daily plus~        -  maraviroc 150 mg daily On day 10 subjects will undergo an intensive pharmacokinetic~          visit.~      On day 11, subjects will modify their current antiretroviral therapy to the following:~        -  darunavir/ritonavir 800/100 mg daily plus~        -  maraviroc 150 mg daily (i.e. tenofovir/emtricitabine will be discontinued) On day 20~          subjects will undergo an intensive pharmacokinetic visit. Following completion of this~          study phase, subjects will recommence their usual antiretroviral treatment regimen and~          attend for a study follow up visit.~   "
169362|NCT01348750|"~     This is a randomized controlled 2 year trial at Camp Pendleton, CA to determine whether a~     complementary medicine intervention (Healing Touch with Guided Imagery, HT+GI) reduces~     Posttraumatic Stress Disorder (PTSD) symptoms as compared to treatment as usual (TAU) in~     returning combat-exposed active duty military with significant PTSD symptoms. Secondary aims~     will evaluate the effect of HT and GI on measures of depression, hostility, and general~     health status in this population.~   "
169366|NCT01348698|"~     Background:~      - Tumors of the adrenal gland are common. Most of them are not cancerous. However, there are~     no tests that can accurately tell which adrenal tumors are cancerous and which are not. The~     only way to tell is to remove the tumor with surgery and then examine it. Researchers have~     been using new methods to study samples of adrenal tissue. These methods may help identify~     whether the cells are or may become cancerous without an operation. This information will~     help doctors determine which tumors will need to be removed.~      Objectives:~      - To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods~     that may help identify cancerous or precancerous cells.~      Eligibility:~      - Individuals at least 18 years of age who have an adrenal tumor that may or may not be~     cancerous.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood and~          urine tests, and imaging studies.~        -  Participants will be examined to determine whether they have a specific type of adrenal~          tumor~      (pheochromocytoma).~        -  Participants whose tumor does not secrete hormones will have a tumor biopsy to collect~          tissue for study.~        -  Participants who have a large tumor or one that secretes hormones will have standard~          surgery to remove the tumor. Tissue will be collected for study.~        -  Researchers will examine the collected tissue. They will try to determine whether the~          cells are cancerous or may become cancerous.~        -  Participants will be asked to return to the National Institutes of Health Clinical~          Center every year for about 5 years. During these visits they will have imaging studies,~          lab tests, and a physical examination.~   "
169367|NCT01348685|"~     To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its~     component mixtures and whey protein on subjective appetite and food intake in young men.~   "
169368|NCT01348672|"~     Canadians fear loss of vision more than any other disability. Vision loss has an enormous~     impact on quality-of-life and is extremely costly from a societal and economic perspective.~     In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting~     for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by~     65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial~     cost of vision loss in Canada is $15.8 billion per year. There is a general perception that~     vision loss is normal with aging but 75% of vision loss is estimated to be preventable. The~     major causes of severe vision loss are age-related macular degeneration (ARMD), glaucoma,~     particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR). Canada is~     headed for an epidemic of age-related eye disease and, unless something is done to prepare~     for this, severe vision loss will have significant consequences in terms of societal and~     economic costs. Through this proposed Research Program, and in conjunction with the~     investigators international academic and private sector partners, the investigators will~     build and develop unique quantitative imaging technologies to permit non-invasive assessment~     of visual changes, structural changes in the thickness of the retina at the back of the eye~     and also changes in the amount of blood flowing through the blood vessels that feed the~     retina with oxygen. This research will add to the investigators basic knowledge in predicting~     the development of sight-threatening change in patients with the three diseases, and~     facilitate earlier detection of the problem to help us discover earlier treatments for people~     with these conditions. The reliability of each imaging technology will be assessed by~     determining its ability to differentiate between diseased and healthy eyes. Cross-sectional~     analyses at yearly intervals, as well as change over time analyses, will be undertaken.~   "
169369|NCT01348659|"~     The aim of the study is to describe the effects of hypertonic saline/hydroxyethylstarch~     solution in comparison to saline solution for 25 + 25 patients undergoing coronary bypass~     grafting surgery (CABG) using CPB. The study fluid will be given into the venous reservoir of~     the CPB circuit after aortic declamping. Primary endpoints are the changes in body weight and~     extracellular water from baseline to the first postoperative morning.~   "
169370|NCT01348646|"~     The purpose of this study was to see whether a brief intervention given in adolescence has an~     effect on smoking in adulthood. The investigators also wanted to clarify the significance of~     some known psychosocial risk factors of smoking in adulthood.~   "
169371|NCT01348633|"~     Canadians fear loss of vision more than any other disability. Vision loss has an enormous~     impact on quality-of-life and is extremely costly from a societal and economic perspective.~     In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting~     for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by~     65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial~     cost of vision loss in Canada is $15.8 billion per year. There is a general perception that~     vision loss is normal with aging but 75% of vision loss is estimated to be preventable. The~     major causes of severe vision loss are age-related macular degeneration (ARMD), glaucoma,~     particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR). Canada is~     headed for an epidemic of age-related eye disease and, unless something is done to prepare~     for this, severe vision loss will have significant consequences in terms of societal and~     economic costs. Through this proposed Research Program, and in conjunction with our~     international academic and private sector partners, we will build and develop unique~     quantitative imaging technologies to permit non-invasive assessment of visual changes,~     structural changes in the thickness of the retina at the back of the eye and also changes in~     the amount of blood flowing through the blood vessels that feed the retina with oxygen. This~     research will add to our basic knowledge in predicting the development of sight-threatening~     change in patients with the three diseases, and facilitate earlier detection of the problem~     to help us discover earlier treatments for people with these conditions. The reliability of~     each imaging technology will be assessed by determining its ability to differentiate between~     diseased and healthy eyes. Cross-sectional analyses at yearly intervals, as well as change~     over time analyses, will be undertaken.~   "
169372|NCT01348620|"~     This is a single-institution, prospective, randomized controlled trial. Subjects determined~     to need a cholecystectomy will be consented for surgery and study participation prior to~     enrollment in this study. Patients will then be randomized to receive either a single port~     laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.~   "
169373|NCT01348607|"~     RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and~     improve the quality of life of patients with excessive daytime sleepiness after cancer~     therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more~     effective than a placebo in reducing daytime sleepiness in these patients.~      PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or~     modafinil to see how well they work compared with a placebo in treating young patients with~     excessive daytime sleepiness after cancer therapy.~   "
169408|NCT01348152|"~     The primary objective of this study is to evaluate the improvement in the severity of~     constipation (from Baseline to Day 28), determined by the constipation severity instrument~     (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100~     administered for 28 consecutive days in adult subjects with functional constipation.~   "
169409|NCT01348139|"~     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single~     doses of three different dry powder inhalation formulations of AZD3199 administered via~     Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and~     compared to placebo in patients with persistent asthma.~   "
169374|NCT01348594|"~     Infertility is a common and psychologically devastating problem for 20% of Canadian couples.~     Approximately, 20% of infertile couples are diagnosed with unexplained infertility and left~     without an explanation for their inability to have a baby. Pathological uterine receptivity~     and embryo implantation are hypothesized mechanisms underlying sub-fertility in these~     couples. Embryo implantation requires a complicated sequence of events involving the~     differentiation of endometrial cells to attain uterine receptivity and the synchronized~     interaction between maternal and embryonic tissues. Vitamin D has been hypothesized to play a~     role in this poorly understood process. Vitamin D is a known regulator of signal transduction~     pathways involved in embryo implantation and its receptors are involved in calcium-regulation~     in various reproductive tissues including, the ovary, uterus, and placenta. In Canada, the~     prevalence of Vitamin D insufficiency is approximately 34-50%. The goal of the proposed study~     is to determine the prevalence of vitamin D insufficiency in an infertile population and~     whether this prevalence is higher than in average Canadian reproductive age women. More~     importantly, we will investigate whether vitamin D insufficiency in our infertile population~     translates to impaired implantation and reduced clinical pregnancy rates. Insight into~     vitamin D's role in reproduction is essential not only to provide scientific understanding of~     the mechanism underlying embryo implantation, but also because vitamin D supplementation~     could provide an easy and safe means of treating infertility.~   "
169375|NCT01348581|"~     The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of~     fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.~      The wound dressing is indicated for the management of difficult to heal and chronic wounds.~     The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary~     dressing is put on top. Further dressing of the wound depends on the etiology.~      The indications for use are:~        -  partial and full-thickness wounds~        -  pressure ulcers~        -  venous ulcers~        -  diabetic ulcers~        -  chronic vascular ulcers~        -  tunneled/undermined wounds~        -  trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)~   "
169376|NCT01348568|"~     Healthy individuals with type 2 diabetes will receive intensive counseling on food selection~     to improve glucose control using either high cereal fiber dietary strategies or low glycemic~     index foods especially canola oil containing bread. The treatments will last 3 months with~     bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or~     both diets, then use of high fiber, and/or low glycemic index foods with canola oil, may~     provide another potential way to improve glucose control and lower cholesterol levels in~     non-insulin dependent diabetes.~   "
169377|NCT01348555|"~     Pulmonary administered anticholinergic agents have shown their importance in the chronic~     obstructive pulmonary disease (COPD) management to reduce morbidity, disability and~     mortality. To date, the recommended treatment of moderate to severe COPD patients consist in~     the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a~     medical need in new product that could exhibit both anti-inflammatory and strong~     bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.~      Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound~     and could bring new option in the treatment of this life-threatening disease.~   "
169378|NCT01348542|"~     The purpose of this study is to evaluate the effect of a 3 month medication trial of~     Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic~     insomnia.~   "
169379|NCT01348529|"~     The main aim of this study is to test whether cognitive behavior therapy could be effective~     in treating obsessive compulsive disorder. Here, the investigators test the in group effects~     of a 15 week long treatment delivered via the Internet for residents in Stockholm County.~   "
169380|NCT01348516|"~     The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after~     single/multiple dosing.~   "
169381|NCT01348503|"~     The purpose of this study is to evaluate the combination of Revlimid® (lenalidomide) and~     Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma that can't be cured with~     surgery.~   "
169382|NCT01348490|"~     To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms~     and potential side effects in patients with PMF, PPV-MF and PET-MF who have platelet counts~     of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose optimization from~     the starting ruxolitinib level of 5 mg bid will be associated with reductions in~     splenomegaly, MF-associated symptoms and inflammatory cytokine levels.~   "
169383|NCT01348477|"~     The investigators describe a new surgical technique for inguinal hernia open repair, which~     will be compared with the Lichtenstein technique. The investigators seek to find the~     difference between the two techniques in postoperative pain.~   "
169384|NCT01348464|"~     The aim of this study is to compare patients who undergone single-port access laparoscopic~     appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA)~     in a prospective randomized trial~   "
169385|NCT01348451|"~     This is a first-in-human trial of spinal derived stem cells transplanted into the spinal cord~     of patients with Amyotrophic Lateral Sclerosis (ALS). The goal of the study is to see if the~     cells and the procedure to transplant them are safe.~   "
169386|NCT01348438|"~     The purpose of the study is to evaluate the safety and clinical performance of the Engager~     Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis~     who are at high risk for surgical valve replacement.~   "
169387|NCT01348425|"~     This randomized, post-market clinical study is intended to evaluate the delivery and~     deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80~     mm) for treatment of lesions of the above-the-knee femoropopliteal artery.~   "
169410|NCT01348126|"~     The purpose of this study is to determine whether combining ganetespib (STA-9090) with~     docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced~     non-small cell lung cancer.~   "
169424|NCT01347944|"~     The purpose of this study is to collect clinical and laboratory data for patients affected by~     intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were~     prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for these~     patients since October 2008 based on a local disposition of the Italian Drug Agency (AIFA)~     issued according to a National law named 648/96.~   "
169388|NCT01348412|"~     Standard treatment of metastatic colorectal cancers relies on fluoropyrimidines, irinotecan~     alone or in association with fluoropyrimidines, oxaliplatin in association with~     fluoropyrimidines, bevacizumab and anti EGFR antibodies. After failure of classical regimen~     the national reference frame on the basis of phase II study proposes an association of~     fluoropyrimidine and mitomycin. These treatments give response rates of 10-20% with~     progression free survivals from 2 to 3 months. Hepatic intra-arterial chemotherapy is logical~     in the case of isolated hepatic metastases nonaccessible to curative resection: 1) hepatic~     metastases are vascularized by hepatic arterial system in contrast to nontumoral hepatic~     parenchyma; 2) arterial perfusion of oxaliplatin leads to a strong extraction by the liver~     during the first passage, a high intra-tumoral concentration and a low systemic~     concentration. So oxaliplatin is a drug of choice for arterial treatment but combination with~     fluoropyrimidines is impossible because of need for prolonged perfusion. Floxuridin is not~     available in France. Raltitrexed, a definitive inhibitor of the thymidylate synthase, does~     not require a prolonged perfusion and could be a good substitute.In a previous pilot study we~     demonstrated the feasibility, safety and efficacy of combination of raltitrexed and~     oxaliplatin arterial perfusion. Now we propose a phase II randomized clinical trial to~     evaluate the efficacy of hepatic arterial infusion of raltitrexed and oxaliplatin association~     versus standard chemotherapy for patients with metastases of colorectal origin restricted to~     the liver after failure of conventional chemotherapy.~   "
169389|NCT01348399|"~     The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in~     the real world daily practice as compared with other drug eluting stents (DESs)~   "
169390|NCT01348386|"~     BACKGROUND:~      Molluscum contagiosum is a non-serious children viral infection. Because of its natural~     history, being highly contagious and the aesthetic and psychotherapeutic effects of its~     treatment, the investigators intend to test the use of different concentrations of potassium~     hydroxide solution in the primary care setting.~      METHODS:~      A double blind, randomized clinical trial, in three groups of topic treatment is designed.~     The intended treatment consists on a daily application of potassium hydroxide in aqueous~     solution at 10% and 15% concentration, versus a placebo administered to the control group. 4~     follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and~     tolerance.~      The main target of the trial is to determine the healing rate, defined as lesion~     disappearance in the affected zones after the topic application of the treatment. Secondary~     targets are the main characteristics and evolution of the affected zone (surface, number of~     lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching,~     burning, pain), recurrence rate estimation and natural evolution of lesions in the control~     group.~   "
169391|NCT01348373|"~     The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated~     stent in patients with STEMI with other drug-eluting stents (DESs).~   "
169392|NCT01348360|"~     The objective of this study is to evaluate effectiveness and safety of Nobori stent in the~     real world daily practice as compared with first-generation drug-eluting stents (sirolimus-~     or paclitaxel-eluting stents).~   "
169393|NCT01348347|"~     This open-label phase I dose escalation trial, 1230.15, is the first trial with Volasertib in~     Japanese advanced cancer patients. The trial will investigate the maximum tolerated dose~     (MTD), safety, tolerability, and preliminary efficacy of this specific polo-like kinase 1~     (Plk1) inhibitor in advanced cancer patients.~   "
169394|NCT01348334|"~     The purpose of this study is to determine the clinical results contributions to surgical~     success,and complications of mixed type of mesh materials as well as prolen mesh materials in~     sling surgery in a 3 year follow-up the first time in literature.~   "
169395|NCT01348321|"~     Different immunologic mechanisms contribute to development of inflammation in acne vulgaris~     and immunologic effect of levamisole has been demonstrated.~      Objective: The aim of this study was to compare azithromycin and levamisole with azithromycin~     alone in the treatment of acne vulgaris.~   "
169396|NCT01348308|"~     The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a~     combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients~     counts may accelerate the kinetics of immune restoration and decrease the risk of disease~     progression and death.~      It is a randomized, versus placebo, double-blind trial, conducted in France, Spain and Italy.~   "
169397|NCT01348295|"~     This observational study includes questionnaires send to doctors in all units treating~     pediatric patients with mechanical ventilation in Finland. Additionally all units treating~     pediatric patients with mechanical ventilation are invited to perform a quality control-like~     follow up for 3 months. Patient identity data is not collected, and no interventions to~     treatment are made.~   "
169398|NCT01348282|"~     The current project proposes the comparison of two pharmacologic strategies as adjunctive~     treatments for the improvement of HIV-associated neurocognitive disruption, additionally to~     use of HAART. The investigators propose the use of the compound that has shown greatest~     benefits in this context to date, the lithium, versus the use of a well-tolerated and~     promising drug in other pathologies with neurocognitive affectation, such as Alzheimer or~     Parkinson diseases, which is the rivastigmine. In those other diseases, this second compound~     has recently offered a good tolerability, but also benefits on attention, memory and other~     neurocognitive areas. Both study groups, patients on therapy with lithium and patients on~     therapy with rivastigmine, will be compared to a control group, which will not initiate any~     other treatment (therefore only continuing antiretroviral therapy). The investigators are~     aware that this proposal will offer new relevant data for the study of neurocognitive~     improvement in HIV infection, as well will allow a better knowledge of clinical management of~     HIV-infected patients with CNS disease, an aspect that is a common clinical concern today.~   "
169399|NCT01348269|"~     The primary aim is to test the reduction of bone marrow edema syndrome after a singular~     intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of~     the edema is defined as biometric data measured by the use of MRT before and six weeks after~     treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the~     treatment of painful bone marrow edema. A statistically significant reduction of the edema in~     the MRT is considered as evidence for efficacy.~   "
169946|NCT01341106|"~     This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect~     on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in patients~     with chronic hepatitis B infection.~   "
169401|NCT01348243|"~     Clodronic acid 100 mg/3,3 ml is used to prevent and treat postmenopausal osteoporosis.~      The intramuscular formulation, which is given at a dose of 100 mg every 7 o 14 days, is at~     least as effective as daily oral therapy and appears more effective than intermittent~     intravenous treatment. Intramuscular clodronic acid in particular has also been associated~     with improvements in back pain. The drug is well tolerated, with no deleterious effects on~     bone mineralization, and use of parenteral therapy eliminates the risk of gastrointestinal~     adverse effects that may be seen in patients receiving oral bisphosphonates therapy.~      In order to simplify the therapeutic dosing regimen, reducing the number of administrations~     per month, and therefore increase adherence to bisphosphonates therapy of the patient, a new~     formulation of disodium clodronic acid containing 200 mg/4 mL for i.m. administration has~     been developed. Lidocaine in this new formulation, as local anaesthetic, is maintained at the~     same concentration as in the 100 mg clodronic acid formulation.~      The pharmacokinetics and tolerability of the intramuscular formulation of clodronic acid 200~     mg in comparison to the marketed formulation clodronic acid 100 mg was evaluated in healthy~     post-menopausal volunteers. Two formulations were similar in terms of amount and rate of~     clodronic acid urinary excretion and in terms of safety profile.~   "
169402|NCT01348230|"~     When babies are premature, or born before they are fully developed, they face many different~     medical problems, some of which are quite devastating, such as cerebral palsy, mental~     retardation, blindness, deafness, severe intestinal problems, and developmental delays.~     Unfortunately, in more than half the cases of premature births, there is no procedure or test~     that an obstetrician can employ to predict if a fetus is at risk for premature birth,~     especially when the mother is healthy. This study seeks to determine if certain factors found~     in the urine undergo specific changes that can be used to detect premature births of this~     type before they happen.~   "
169403|NCT01348217|"~     Exclusive concomitant radiochemotherapy (RCT) at a dose of 50 Gy delivered over 5 weeks,~     according to the RTOG 85-01 protocol, has led to improved 5-year survival in 25% of patients,~     whereas no patients survived for 5 years using radiotherapy alone for patients with~     esophageal cancer. Surgery, even when combined with preoperative RCT, also gives~     disappointing results for locally advanced tumors, which casts serious doubts on the~     usefulness of preoperative radiotherapy. By varying the fractionation schedule, the length of~     treatment or the radiotherapy volumes, it has become possible to obtain levels of~     loco-regional relapse of around 35 to 45%. After reviewing the results for loco-regional~     relapse according to the dose of radiation and the recommended radiotherapy volumes, we aimed~     to investigate why increasing the dose of radiation has no impact in esophageal cancers.~     Although INT-0123 phase III trial showed no benefit of dose escalation in esophageal cancer,~     some issues remain unclear as most of the patients who died in the experimental arm were~     treated above 50Gy. Moreover, only the tumor was treated up to 64Gy while involved nodes were~     not considered for dose escalation in this trial. In the RTOG 85-01phase III trial, an~     elective nodal irradiation from subclavicular fossa up to the esophagogastric junction was~     performed with a 2D technique, delivering 30Gy which could be considered as not appropriate.~      In this randomized phase II/III trial, we aim to test an exclusive concomitant~     chemoradiotherapy for patients with non resectable esophageal cancer with a dose escalation~     up to 66Gy on the primary tumor as well as the involved nodes using a 3D conformal technique~     combined with a 40 Gy elective nodal irradiation on lymph node stations (as defined by the~     RTOG) with a risk of microscopic involvement ≥ 20%.~   "
169404|NCT01348204|"~     The purpose of the study is to develop new biomarkers for studies of cystic fibrosis (CF).~     Defects in the gene encoding Cystic Fibrosis Transmembrane Regulator (CFTR) cause CF, an~     autosomal recessive disorder affecting mainly the pulmonary and digestive tract, leading to~     early death largely due to progressive loss of pulmonary function. In vitro experiments show~     that quercetin - a dietary supplement with a well-established safety profile for human use,~     including clinical trials in a variety of disorders encompassing cancer, heart disease, and~     as an anti-inflammatory agent - induces activation of CFTR. The nasal potential difference~     (NPD) test is a measurement of voltage across the nasal membrane and as a fundamental~     biomarker for CFTR activity in vivo. The NPD is a useful, well-established tool in CF~     research to determine both diagnoses as well as to measure the effect of new therapies. In~     vitro experiments show that quercetin induces activation of CFTR additive to that seen with~     current NPD reagents. In addition, it activates rescued mutant CFTR in vitro (∆F508 CFTR the~     most common cause of CF), whereas conventional agonists do not. Preliminary in vivo~     experiments mirrored these results and show that quercetin activates CFTR in human (n=12) NPD~     tests. Importantly, quercetin perfusion was well-tolerated by a validated sinus questionnaire~     and physician assessed nasal examination rating. These studies provide strong support for use~     of quercetin as potentiator of CFTR Cl- channel function by nasal administration. By adding~     quercetin to the sequence of perfusion solutions for NPD, the investigators may be better~     suited to detect ∆F508 CFTR activity of rescued mutant protein in the CF patient population.~   "
169405|NCT01348191|"~     It has been recognized for many decades that high thyrotrophin (TSH) levels in pregnant women~     are associated with poor obstetric outcome. Also, there is evidence that high TSH is related~     to fetal position at term, including breech which in turn is associated with obstetric~     complications.~      However, the mechanism behind remains to be elucidated.~      The current project is of basic-fundamental nature. It is used to better understand basis~     physiological processes. As in many other studies of similar basic nature, few numbers are~     always included.~      If a TSH receptor will be detected, future randomized controlled trials (RCT) might be~     worthwhile with large numbers of women who will be treated with thyroxine to possibly prevent~     abnormal fetal position during normal pregnancy.~      The aim of the current study is to evaluate whether a TSH receptor can be demonstrated in~     human myometrium. If so, the pathophysiology of high TSH in relation to obstetric outcome~     will become more clear. Furthermore, the aim is to test the myometrium in vitro for its~     relaxation and contractility and for the conductance of electropotentials.~   "
169406|NCT01348178|"~     This is a retrospective study assessing pre- and postoperative radiographic indices of hip~     dysplasia in order to identify factors predicting failure following Periacetabular Osteotomy~     (PAO).~   "
169407|NCT01348165|"~     Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy~     Male Volunteers~   "
169411|NCT01348113|"~     Excessive alcohol consumption is a worldwide major public health problem. Brief interventions~     have shown to be an efficient treatment modality for problem drinkers, but have never been~     tested in scheduled surgery.~      Patients will be recruited in various surgery units in 7 hospital in France. All patients~     attending a scheduled surgery will be screened during the visit with the anaesthesist by the~     Alcohol Use Disorders Identification Test (AUDIT). Patients aged 30-75 with an AUDIT between~     7 and 12, corresponding to at risk or harmful use, will be proposed to enter a control study~     and randomized between a brief intervention by a trained nurse during the post-surgery~     hospitalisation and no intervention. Twelve months after the surgery, a research technician~     will interview by telephone patients and evaluate AUDIT and alcohol consumption of the last~     month.~   "
169412|NCT01348100|"~     This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation~     of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in~     support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the~     safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and~     safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be selected~     for assessment in Phase C. Phase C of this study is designed to define the dose-exposure~     relationship of the selected form and to provide information that will permit a comparison of~     the risk-benefit ratio of several doses of the study drug to enable optimal dose selection~     for later studies.~   "
169413|NCT01348087|"~     The purpose of this study is to generate long-term safety, tolerability and efficacy data for~     AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212~     (NCT01253629).study and patients who have participated in the previous proof-of-concept study~     CAFQ056A2204 (NCT00718341).~   "
169414|NCT01348074|"~     It is not known how to best restart warfarin after temporary withdrawal. Participants will be~     randomized to two groups. Group 1 will restart warfarin at their usual maintenance dose,~     group 2 will restart warfarin at double their maintenance dose for two days followed by their~     usual maintenance dose. The main outcome parameter will be the number of patients who are~     back in therapeutic INR (international normalized ratio) range 4, and 9 days after restarting~     anticoagulation with warfarin. Thromboembolic and/or bleeding events will be recorded as~     additional parameters. These data will be collected by a standardized telephone interview at~     1 month. In addition, the investigators will evaluate a possible prothrombotic state by~     measuring the potential of thrombin generation and D-dimers in the subset of patients~     visiting HHS-General Hospital for their INR tests.~   "
169415|NCT01348061|"~     This is an experimental medicine study to evaluate the kinetics of cerebrospinal fluid (CSF)~     biomarkers in subjects with Alzheimer's disease (AD) or progressive supranuclear palsy (PSP)~     compared to healthy controls using a heavy water (2H2O) labeling method. This study is~     exploring the time profile of appearance and disappearance of pulse deuterium-labeled cargo~     proteins in CSF of subjects with AD and/or PSP, which is different from healthy controls, due~     to deficits in fast axonal transport.~   "
169416|NCT01348048|"~     Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in~     patients with a life threatening disease such as advanced cancer. Many patients with advanced~     cancer are not in contact with SPC. Previous studies have shown that among advanced cancer~     patients not referred to SPC there is a significant prevalence of symptoms, problems and~     needs. The aims of the present study are to investigate whether patients with metastatic~     cancer, who report palliative needs in a screening, will benefit from being referred to SPC~     and to investigate the economical consequences of such a referral.~   "
169417|NCT01348035|"~     This is a prospective 5-year study to compare the change in total kidney volume (TKV) before~     and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.~   "
169418|NCT01348022|"~     This study is a multicenter, open label, prospective, single arm trial~      Single arm group; following angiography, eligible patients with unprotected LMCA stenosis~     >50% by visual estimation, which is equally treatable by the both treatment strategy (EES~     stenting or CABG), will be treated with EES~   "
169419|NCT01348009|"~     Cisplatin, an intravenously administered platinum agent, in combination with an intravenously~     administered taxane and capecitabine has been shown to improve time to disease progression~     and overall survival in previously untreated patients with gastric cancer.~      This study is being performed to evaluate an orally administered taxane (tesetaxel) in~     combination with cisplatin and capecitabine in previously untreated patients with gastric~     cancer.~   "
169420|NCT01347996|"~     Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia~     Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This~     is an international, multicenter, open-label study to evaluate the effects of remission~     maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune~     system cells (T and NK cells) and prospectively defined markers of immune response that are~     known to reflect T and NK cell ability to combat AML.~   "
169421|NCT01347983|"~     24 week open-labeled extension study to continue monitoring the same group of patients in the~     previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of~     tocilizumab.~   "
169422|NCT01347970|"~     This randomized phase II trial studies the side effects and how well low-dose carvedilol~     works in preventing congestive heart failure (CHF) in younger cancer survivors exposed to~     high dose anthracyclines for management of childhood cancer. Carvedilol may help lower the~     risk of cardiovascular complications~   "
169423|NCT01347957|"~     Preclinical studies showed the Nitric Oxide (NO) gel significantly promoted hair follicle~     formation and growth in both rat and mouse models. The NO gel induced major physiological,~     developmental, and structural changes in the skin of mammals to increase the number of hair~     follicles, follicle stem cell development and regeneration as well as hair shaft elongation,~     and accelerated hair growth rate. Based on our animal model findings, the investigators~     hypothesize that the nitric oxide releasing gel could be used as a medical treatment for hair~     growth in humans. The objective of this trial is to evaluate the safety and efficacy of this~     NO gel (XN-001), in comparison with a placebo gel in subjects in a 24-week treatment~     schedule.~   "
169947|NCT01341093|"~     The purpose of this study is to elaborate an educative program that includes telephone~     follow-up and assess its impact on the perceived health status of patients submitted to~     percutaneous coronary intervention.~   "
169425|NCT01347931|"~     The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic~     respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system~     will accomplish this by providing oxygen under pressure and augmenting the subject's~     spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted~     ventilation, and a comfortable low-profile device, will result in a mean improvement in~     perceived well-being and ability to perform ADLs, as measured by patient-reported outcome~     (PRO) instruments.~   "
169426|NCT01347918|"~     The aim of this project is to demonstrate and validate the ionizing radiation free and non~     invasive assessment of small intestinal anatomy, content and function in healthy and disease~     by a newly developed combined proton (1H) and fluorine (19F) magnetic resonance imaging (MRI)~     framework. Meal induced and pathology related alterations in small intestinal motor activity,~     gas distribution and anatomy of healthy volunteers and patients with irritable bowel syndrome~     (IBS) will be analyzed with this non invasive MRI approach.~      The multinuclear imaging framework consists of a 1H and 19F capable clinical 3T MRI system~     with standard 1H abdominal surface coils, a dual-channel transmit-receive abdominal 19F~     surface coil, fluorine labelled impermeable and biocompatible capsules for oral~     administration (19F capsule) and a 19F projection imaging sequence allowing for the~     non-invasive detection of the gastrointestinal positions of single and multiple ingested~     capsules in real time. Dedicated post-processing algorithms are applied to extract parameters~     of intestinal motor activity from the detected intraluminal capsule movements.~      The proposed unique imaging modality allows for the concurrent, non invasive and repeated~     analysis of important physiologic parameters of intestinal function together with detailed~     anatomical information and thus presents an ideal tool for the evaluation of the analyzed~     parameters as potential biomarkers in IBS.~        -  Trial with medical device~   "
169427|NCT01347905|"~     The objective of this study is to investigate if weight loss, in particular due to adipose~     tissue loss, in obese patients will reverse the obesity-related reduction of iron absorption,~     and if this is due to a decrease in hepcidin concentrations. Additionally, the investigators~     will investigate changes in iron incorporation into erythrocytes due to a reduction of iron~     sequestration by the adipose tissue and reticuloendothelial system. The investigators expect~     that by decreasing adiposity, circulating hepcidin levels will decrease, iron absorption and~     incorporation into erythrocytes will increase and as a result iron status will be improved.~   "
169428|NCT01347892|"~     The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo NT~     Graft treatment of articular cartilage lesions in the ankle in a standard clinical setting.~     Outcomes to be assessed include pain, function, activity levels and healthcare resource use.~   "
169429|NCT01347879|"~     This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy~     (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that~     Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is~     different compared to vehicle PDT at week 12.~   "
169430|NCT01347866|"~     After the fourth protocol amendment two study arms are evaluated in this clinical protocol:~     PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and~     PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and~     pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum~     tolerated doses are identified, further assessment of these combinations will be done in~     patients with previously treated metastatic colorectal or pancreatic cancer for the~     PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non small~     cell lung cancer for the combination of PF-05212384 plus PD-0325901.~   "
169431|NCT01347853|"~     This was a randomized, double-blind, placebo-controlled study in subjects who underwent major~     surgery. Each subject's study participation consisted of a screening visit and a treatment~     period of up to 5 days. Following surgery (Day 0), subjects were randomly assigned to receive~     intranasal ketorolac 30 mg or intranasal placebo when the pain intensity (PI) rating equaled~     at least 40 mm on a 100-mm visual analog scale (VAS). Subjects received study drug every 8~     hours for 48 hours and then 3 times daily for up to 5 calendar days in total; the frequency~     of dosing could be reduced after 48 hours. Starting at the time of the first dose of study~     drug and continuing for the first 48 hours after surgery, the subjects had access to morphine~     sulfate (MS) administered via patient controlled analgesia (PCA). After PCA was no longer~     required, backup pain relief was provided by another standard nonsteroidal anti-inflammatory~     drug (non-NSAID) analgesic regimen. If the subjects were discharged before postoperative Day~     4, they could self-medicate at home through postoperative Day 4. A safety follow-up~     evaluation was conducted by telephone approximately 14 days after the end of dosing in a~     subset of subjects (n = 60).~      The primary objective was to evaluate the analgesic efficacy of multiple intranasal doses of~     ketorolac administered for up to 5 days. The secondary objective was to evaluate the safety~     and tolerability of this dosing regimen.~   "
169432|NCT01347840|"~     The objective of this study is to determine whether the metabolic, endocrine and energetic~     response to short term caloric restriction are factors in weight loss in subjects having~     gastric bypass (GB) surgery.~   "
169433|NCT01347827|"~     The goal of this study is to determine if off-pump CABG surgery is associated with better~     cerebral tissue oxygenation when compared with on-pump CABG. In addition, the investigators~     would like to compare the results of two different monitors of brain tissue oxygenation with~     each other, and assess the correlation between brain tissue oxygenation and oxygenation~     measurements in renal and muscular tissue, as well as with conventional hemodynamic and~     metabolic variables, such as central venous oxygen saturation (ScvO2). Finally, the~     investigators aim to determine if duration and extent of cerebral oxygen desaturation predict~     outcome variables such as postoperative cognitive performance.~   "
169434|NCT01347814|"~     The purpose of this study is to determine whether domperidone was sufficient to accelerate~     gastric emptying of a high-fat solid meal and reduce satiety responses in a healthy adult~     population.~   "
169435|NCT01347801|"~     The purpose of this study is to determine the role of inflammation and the insulin regulating~     hormone GLP-1 during critical illness.~   "
169456|NCT01347528|"~     TELEMED-HF is a randomized, controlled clinical intervention trial designed to: (1) examine~     the efficacy of an electronic Medication Adherence Support System (MASS) in improving and~     monitoring patients' medication adherence; to (2) i determine the effect of medication~     adherence on hospitalization and health care consumption.~   "
169436|NCT01347788|"~     Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib~     works by blocking the angiogenesis, or the growth of new blood vessels, to the tumor. This~     is similar to how several other cancer drugs work but in addition Cabozantinib also blocks~     other pathways that may be responsible for allowing cancer cells to become resistant to these~     other anti-angiogenic treatments. So far cabozantinib has been investigated in treating~     brain cancer and a rare form of thyroid cancer. This study will explore lower doses of~     cabozantinib with the goal to find the most effective, safe, and tolerable dose without~     undesirable side effects.~   "
169437|NCT01347775|"~     This study will investigate whether inspiratory muscle training in patients with end stage~     renal failure can improve strength and function.~   "
169438|NCT01347762|"~     Cannabis use disorders are an important public health problem in the United States, but there~     are no effective medications available to treat these disorders. The investigators intend to~     test a medication with interesting properties, nabilone, as a treatment for cannabis~     dependence and to study the relationship of this treatment with the brain using functional~     MRI brain scans. Nabilone and marijuana have similar effects upon behaviors and the human~     body, suggesting that nabilone may decrease cannabis withdrawal symptoms while allowing~     treatment-seeking patients to benefit from behavioral treatments when they are trying to stop~     using cannabis. The investigators propose to assess the relationship of nabilone, when added~     to behavioral treatment, on cannabis use patterns in cannabis-dependent patients. The~     investigators also aim to determine the effects of nabilone on performance on~     neuropsychological tests and to assess the correlation of neuropsychological performance to~     brain changes using functional MRI brain scans. The investigators hypothesize that patients~     receiving nabilone will reduce their use of cannabis more than patients receiving placebo~     during this 10-week treatment trial.~   "
169439|NCT01347749|"~     This project will study whether a new therapy that includes the practice of forms of~     meditation is helpful for combat veterans returning from deployments in Iraq or Afghanistan~     suffering with posttraumatic stress disorder (PTSD). Mindfulness meditation cultivates~     present-focused, non-judgmental attention to ones body, emotions, and thoughts, and is~     proposed to lead to a greater sense of well-being and acceptance and better tolerance of~     painful and distressing emotions. Compassion and loving-kindness meditations help~     stabilize positive emotions like love and compassion, and may also be helpful for chronic~     pain, and possibly depression and PTSD.~      This study will compare a 16 week psychotherapy group for PTSD involving Mindfulness and~     Self-compassion meditation, with a more standard form of group psychotherapy known as~     Present-centered group therapy. Both therapies will be conducted at the VA Ann Arbor PTSD~     clinic by VA psychotherapists. (The study is also approved by the IRB of the VA Ann Arbor).~     Combat veterans will be randomly assigned to either the Meditation or the standard group~     psychotherapy. All patients will also receive fMRI brain scans before and after the therapy,~     as well as assessment interviews before, at 8 weeks, and immediately post-therapy, and at 3~     mo and 6 mo follow-ups. Saliva cortisol and measures of attention will also be obtained at~     each assessment.~   "
169440|NCT01347736|"~     This pilot clinical trial studies how well scrambler therapy works treating chronic pain in~     patients with rash from varicella zoster virus infection. Scrambler therapy may help relieve~     pain from a rash caused by varicella zoster virus infection~   "
169441|NCT01347723|"~     This pilot clinical trial studies scrambler therapy in treating pain and peripheral~     neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help~     relieve pain from peripheral neuropathy caused by chemotherapy~   "
169442|NCT01347710|"~     The primary objective of the study is to assess the diagnostic efficacy (specificity and~     sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to~     single photon emission computed tomography (SPECT) MPI in the detection of significant~     coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a~     documented history of Myocardial Infarction (MI).~   "
169443|NCT01347697|"~     The trial compares two different techniques for reconstruction of the lesser pelvic floor~     after an extended abdominoperineal excision for locally advanced rectal cancer. The~     alternative reconstruction techniques in the trial are:~        -  a technique using a gluteus maximus myocutaneous flap or~        -  a technique using an acellular porcine collagen implant~      The primary endpoint will be physical performance six months from operation and our~     hypothesis is that the technique using an acellular porcine implant will cause less impaired~     physical performance compared to the technique using a myocutaneous flap.~      The study is interventional, randomized and by definition a comparative effectiveness~     research project.~   "
169444|NCT01347684|"~     The primary aim of the pilot data proposal is to compare usual care (medications) versus~     multi-disciplinary treatment in temporomandibular disorder (TMD) patients.~   "
169445|NCT01347671|"~     The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients~     with painful diabetic neuropathy.~   "
169446|NCT01347658|"~     The purpose of this clinical trial is to characterize drug interactions between one medicinal~     herb: Echinacea purpurea and the protease inhibitor etravirine.~   "
169447|NCT01347645|"~     The purpose of the Phase Ib portion is to find out the highest dose of study drug that can~     safely be given when tested in a small group of subjects.~      The purpose of the Phase II portion is to find out how safe the study drug is when taken at~     the highest dose in a larger group of subjects.~   "
169457|NCT01347515|"~     Hypothesis: A functional olive oil tailored to provide the best relationship between phenolic~     compounds (amount and type) phenolic bioavailability and bioactivity (antioxidant and~     anti-endothelial dysfunction) will be a useful tool for increasing not only circulating HDL~     cholesterol concentration, but also the functionality (antioxidant, anti-inflammatory, and~     reverse cholesterol transport capacity) of human HDL in vivo.~   "
169458|NCT01347502|"~     Using smartphone is increasing in hospital with various purpose and it has more extended~     surface than non-smart phone. Therefore investigators can consider the bacterial~     contamination rate of smartphone will be higher than that of non-smartphone.~   "
169459|NCT01347489|"~     There is no exact scientfic data about gender relationship with cronic pressure wounds (CPW).~     This research is aimed first to reveal gender relationship with CPW and aimed secondarily to~     reveal the gender related couse(es).~   "
169460|NCT01347476|"~     Patients aged 70 years or older had a higher possibility of high risk cancer than younger~     patients.~   "
169448|NCT01347632|"~     This is a research study to determine whether bacterial vaginosis (BV) changes the~     cervico-vaginal tissue (skin covering the cervix and vagina) and makes women at higher risk~     for getting HIV (Human Immunodeficiency Virus). Vaginal and cervical tissue biopsies from~     women with BV will be obtained and infected OUTSIDE the body (ex vivo) with HIV.~      BV is a vaginal infection that develops when there is an imbalance in the normal bacteria~     found in a woman's vagina. It is the most common cause of vaginal discharge among women of~     child-bearing age. BV infections potentially harm the safety of the tissue surrounding the~     cervico-vaginal region. When the cervico-vaginal tissue is not well protected, the risk of~     acquiring HIV from an infected partner might increase significantly. Studies have shown that~     HIV is more common in women with BV than in women with normal vaginal bacteria.~      Treatment of BV typically involves the use of antibiotics. Antibiotics kill harmful bacteria~     and provide a temporary relief from the symptoms caused by the infection. Women participating~     in this study will use the generic antibiotic metronidazole, also known as Flagyl. The Center~     for Disease Control and Prevention (CDC) recommends Flagyl for the treatment of BV.~      The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3~     different time periods:~        1. During a BV infection~        2. Approximately 1 week after completing a 7-day course of metronidazole therapy~        3. Approximately 1 month after completing the 7-day course of metronidazole therapy~      You will not come in contact with HIV during this study - only your samples (after we have~     removed them from your vagina/cervix) come in contact with HIV.~   "
169449|NCT01347619|"~     The investigators propose to evaluate the effectiveness of 3 different methods to promote the~     dissemination and adoption of evidenced-based review guides into the nursing home setting.~     Specifically, the investigators will adapt Comparative Effectiveness Research (CER) Review~     products developed by the Agency for Healthcare Research and Quality (AHRQ), specifically~     related to off-label use of atypical antipsychotic drugs, to improve their penetration into~     practice in the nursing home (NH) setting.~      The investigators propose the following specific aims:~      AIM 1: NEEDS ASSESSMENT To conduct a needs assessment for the NH setting relevant to the AHRQ~     Comparative Effectiveness Research Summary Guide (CERSG) entitled Off-Label Use of Atypical~     Antipsychotic Drugs. The assessment will identify: (a) interest in and barriers to the use~     of the AHRQ atypical antipsychotic CERSG in the NH setting; (b) the key audiences and~     stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to~     integrating comparative effectiveness research products into the NH setting.~      AIM 2: PRODUCTION OF THE TOOLKIT Guided by the needs assessment, the investigators will~     produce a toolkit containing tailored CERSG-based products targeting key audiences and~     stakeholders in the NH setting. The target audience(s) of the final CERSG-based products will~     be identified in Aim 1, and will potentially include: (a) facility leadership [NH~     administrator, Medical Director, Director of Nursing]; (b) prescribers and consultant~     pharmacists; (c) nursing staff [registered nurses, licensed practical nurses, and certified~     nurse assistants].~      AIM 3: EVALUATING THE EFFECTIVENESS OF THE TOOLKIT To evaluate the effectiveness of the~     toolkit and three dissemination strategies using a matched, cluster randomized trial. NHs in~     the first arm will receive the toolkit only and web access to the materials; NHs in the~     second arm will receive the toolkit, web access, periodic audit and feedback reports of~     antipsychotic prescribing to NH leadership, and faxed educational messages adapted from the~     AHRQ atypical antipsychotic CERSG to prescribers; and NHs in the third arm will receive the~     previous items plus face-to-face academic detailing. Primary outcomes of the evaluation are~     the RE-AIM evaluation domains (reach, efficacy, adoption, implementation, and~     maintenance).The investigators will also include an assessment of facility-level changes in~     the use of atypical antipsychotic drugs.~   "
169450|NCT01347606|"~     Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction~     and vascular or neural (such as recurrent nervus) injuries are most important ones. This~     research is aim to prevention of these via intraoperative methylene blue using.~   "
169451|NCT01347593|"~     Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.~   "
169452|NCT01347580|"~     The aim of this study is to determine whether initiation of ticagrelor as early as in the~     ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore~     facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the~     patient.~      The study will assess the efficacy and safety of pre-hospital compared to in-hospital~     administration of ticagrelor in co-administration with aspirin, on restoring the blood flow~     in the occluded heart artery and improving the myocardial perfusion in patients suffering~     from myocardial infarction and planned to have a PCI. Patients can be randomised in either~     one of the 2 arms:~      re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the~     pre-hospital administration and placebo for in-hospital administration.~      or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital~     administration and 180 mg ticagrelor loading dose for in-hospital administration.~      Patients are initially managed by ambulance physician/personnel in pre hospital settings.~     They are then transferred into a Catheterization room to undergo a PCI.~      After the administration of the loading dose of ticagrelor (double blind), patients will~     continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.~   "
169453|NCT01347567|"~     The purpose of this study is to determine if heart failure subjects whose treatment is~     assisted by home BNP measurements integrated into a home health management system will have~     better clinical outcomes than subjects whose treatment includes home health management~     without BNP or than subjects treated by standard care.~   "
169454|NCT01347554|"~     Most of the previous data regarding the efficacy of the everolimus-eluting stent (EES) was~     derived from studies comparing EES with bare metal stent (BMS) or EES with paclitaxel-eluting~     (PES). Although sirolimus-eluting stents (SES) have been shown to be the most efficacious~     drug regarding inhibition of neointima and late loss, there have been no previous head to~     head comparisons between EES and zotarolimus-eluting stent (ZES). Both everolimus and~     sirolimus are macrocyclic lactones that target the mTOR (mammalian target of rapamycin) to~     reduce vascular smooth muscle proliferation after vessel injury and therefore in principle~     may show similar results after stenting in humans. Data pooled from the EES arm that received~     follow up angiography in the SPIRIT III trial and the SES arm in the SIRIUS trial show~     similar rates of binary restenosis and late loss. However, the stent and polymer platform is~     not the same between the EES and ZES and it is reported that the EES system has the thinnest~     stent + polymer thickness (88.6um) of all of the previously KFDA-approved drug-eluting stent~     (DES). In addition, there are no data available on the efficacy of the EES and ZES in real~     world lesions other than the selected lesions studied in the previous trials, such as acute~     myocardial infarction.~   "
169455|NCT01347541|"~     This pilot study will evaluate the implementation of a stepped care intervention that~     combines Cognitive-Behavioral Therapy, Motivational Interviewing, psychotropic medications,~     and information technology innovations at a level 1 trauma center to community linkage~     components to reduce the symptoms of posttraumatic stress disorder and related comorbidities~     in injured trauma survivors treated in the emergency department and surgical inpatient~     settings.~   "
169948|NCT01341080|"~     The purpose of this study is to determine if varenicline is effective in improving gait and~     balance impairment in patients with Parkinson disease.~   "
169462|NCT01347450|"~     Background: Cocoa is rich in flavonoids such as (-)-epicatechin and (+)-catechin; these~     compounds have displayed both in vitro and in vivo antioxidant activity.~      Objective: This trial evaluate the regular ingestion effect of both, dark chocolate and cocoa~     powder, over plasma lipids of young males subjected to ex vivo lipid peroxidative conditions.~      Design: Single-blind, controlled and randomized clinical trial including 100 healthy men,~     divided into two groups: 50 subjects received 30 g of cocoa powder and 50 g of dark~     chocolate/d for 1 wk, and the other 50 subjects received placebo.~   "
169463|NCT01347437|"~     HIV is increasing among adolescents and young adults in the US. Antiretroviral medications,~     when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy.~     However, adherence among HIV-infected young people is suboptimal, and few interventions are~     available to help adolescents adhere to treatment.~      The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted~     form of the Life-Steps behavioral intervention) to improve medication adherence among~     HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability to~     recruit, feasibility of intervention delivery with study counselors and all study procedures,~     and initial clinically significant improvement in medication adherence via MEMS caps. This~     research will lay the groundwork for a federal grant application for a multi-site randomized~     controlled intervention trial.~   "
169464|NCT01347424|"~     Contrast enhancement ultrasonography（CEUS）could be used to evaluate the blood flow perfusion~     liver cancer. In this clinical trial, CEUS was used to evaluated the changes of blood flow~     perfusion of Secondary Malignant Neoplasm of Liver after treated with endostatin plus~     paclitaxel and carboplatin regimen.~   "
169465|NCT01347411|"~     The respiratory sleep disorders are a major cardiovascular risk factor. In fact there is~     enough scientific evidence that supports the association between apnea-hypopnea syndrome~     (SASH) and cardiovascular disease (hypertension, stroke, heart failure ....The objective of~     this study is to estimate the effectiveness of the continuous positive pressure airway (CPAP)~     in patient with chronic heart failure with normal ejection fraction but dyastolic dysfunction~     and sleep disordered breathing during the sleep.~   "
169466|NCT01347398|"~     The diagnosis of OSASH requires expensive sleep tests that generate long waiting lists, so we~     need simplified and rapid diagnostic tools. The ApneaLinkTM, is a device that allows the~     assessment of respiratory events by measuring the flow ventilation with a nasal cannula~     connected to a pressure transducer.~   "
169467|NCT01347385|"~     The objective of this study is to determine if the use of a new type of barbed suture~     material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional~     approach of suturing with conventional suture material to close the uterine defect once the~     fibroid has been removed, improves surgical outcomes. Specifically, the investigators will~     investigate the effect of barbed suture on operative time, blood loss, adverse post-operative~     events and hospital stay.~   "
169468|NCT01347372|"~     Peer support (including informational, emotional, appraisal support) has been shown to help~     persons with chronic conditions. The goal of this research is to examine the impact of early~     peer support on the health and quality of life of individuals with early inflammatory~     arthritis (EIA). The investigators hypothesize that early peer support will result in~     improved use of disease modifying anti-rheumatic drug (DMARD) or biologic treatment,~     self-efficacy, coping efficacy, social support, health-related quality of life,~     self-management, and disease activity score as well as reduced anxiety for individuals with~     EIA within 2 years of their diagnosis. In this study, persons with IA will be trained as peer~     mentors using a training program developed for a pilot study. Individuals with EIA will be~     randomized to receive either peer support program or standard care. Peer mentors will be~     paired with a person with EIA to provide one-on-one support (face-to-face or telephone) once~     a week for approximately 30 minutes over a 12-week period. All standard care participants~     will receive the peer mentoring intervention at the end of study. Both groups will be~     evaluated using self-administered questionnaires and clinical assessments, and results of the~     two groups will be compared. This information will be used to design a larger study.~   "
169469|NCT01347359|"~     Peer support (including informational, emotional, appraisal support) has been shown to help~     persons with chronic conditions. The goal of this research is to examine the impact of early~     peer support on the health and quality of life of individuals with early inflammatory~     arthritis (EIA). The investigators hypothesize that early peer support will result in~     improved use of disease modifying anti-rheumatic drug (DMARD) or biologic treatment,~     self-efficacy, coping efficacy, social support, health-related quality of life,~     self-management, and disease activity score as well as reduced anxiety for individuals with~     EIA within two years of their diagnosis. In this study, persons with IA will be trained as~     peer mentors using a training program developed for a pilot study. Individuals with EIA will~     be randomized to receive either peer support program or standard care. Peer mentors will~     be paired with a person with EIA to provide one-on-one support (face-to-face or telephone)~     once a week for approximately 30 minutes over a 12-week period. All standard care~     participants will receive the peer mentoring intervention at the end of study. Both groups~     will be evaluated using self-administered questionnaires and clinical assessments, and~     results of the two groups will be compared. This information will be used to design a larger~     study.~   "
169470|NCT01347346|"~     This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell~     genetherapy for the Wiskott-Aldrich Syndrome.~   "
169471|NCT01347333|"~     This study will evaluate the local control rate as well as acute and late toxicity rates of~     stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary~     liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.~   "
169472|NCT01347320|"~     The investigators want to evaluate if preoperative MRI improves the surgical results,~     especially in respect to surgical margins. The impact on the surgical procedure will be~     evaluated.~      In addition the investigators will examine the accuracy of tumor detection, localization and~     staging.~   "
169473|NCT01347307|"~     This study will evaluate the local control rate as well as acute and late toxicity rates of~     stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine~     tumors.~   "
169474|NCT01347294|"~     The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and~     bleomycin and fibrovein in the treatment of venous malformation.~   "
169475|NCT01347281|"~     The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with~     [18F] HX4 PET imaging in head and neck tumors (ii) correlate the [18F] HX4 PET images with~     blood and tissue markers and (iii) investigate the quality and optimal timing of [18F] HX4~     PET imaging (iv) compare [18F] HX4 PET uptake with [18F] FDG PET uptake before and after~     treatment.~   "
169476|NCT01347268|"~     Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation~     induction and is a life threatening iatrogenic complication. In patients with GnRH agonist~     protocol, both withdrawing GnRH agonist and GnRH antagonist administration are associated~     with a reduction in (E2) levels with subsequent decreasing the incidence and severity of~     OHSS. This work is to compare the clinical and endocrine outcome response of cycles in which~     GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients~     at risk of severe OHSS.~   "
169477|NCT01347255|"~     The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous~     spray ointment, using the psoriasis plaque test modified from the method developed by KJ~     Dumas and JR Scholtz.~   "
169478|NCT01347242|"~     This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell~     genetherapy for the Wiskott-Aldrich Syndrome.~   "
169479|NCT01347229|"~     The purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting~     and supine body positions and correlate the values obtained with conventional tonometers to~     the output provided by the investigational device.~   "
169480|NCT01347216|"~     In view of the manifold options for mono- and combination therapy that have now emerged for~     patients with pulmonary (arterial) hypertension (PH/PAH), controlled clinical trials can only~     provide part of the information needed for optimal management. In order to gather adequate~     data on PAH/PH treatment in routine clinical care, the ongoing COMPERA registry prospectively~     documents consecutive patients with newly initiated treatment of PAH/PAH since May 2007. The~     internet-based registry fulfills high quality standards through several measures (planned~     minimum centre contribution of at least 10 patients per year, automated plausibility checks~     of data at entry, queries, monitoring with source data verification in >50% of participating~     centers). It can be applied, among further purposes, for quality assurance: individual~     centers can confidentially compare their results with the combined outcome of other centers~     and the recommendations from guidelines. It is expected that the register contributes to~     optimization of specific drug therapy for PAH and PH.~      Since July 2013, also children of any age can be documented (COMPERA-KIDS).~   "
169481|NCT01347203|"~     This will be a study existing of 4 periods, to evaluate for a single dose of 4 different~     tablets of DPOC-4088 the absorption and elimination from the body and the potential effect on~     blood clotting. The differences between the tablets are the dose (100 or 200 mg) and the rate~     of release of DPOC-4088 from the tablet (16 or 20 hours). The allocation of the tablets in~     each period will be determined by chance but is known upfront.~   "
169482|NCT01347190|"~     Study to assess safety and tolerability of a single dose of study-drug administered to Cystic~     Fibrosis (CF) patients.~   "
169483|NCT01347177|"~     Adhesive bridges are becoming popular in patients with congenitally missing teeth and these~     are type of bridges that can be done with only minimal or with no preparation to replace the~     missing tooth/teeth. The best clinical gain is the minimal tooth preparation or no need for~     the removal of tooth substance. Treatment for this type of bridges does not usually require~     anaesthesia. In addition, adhesive bridges can provide reasonable aesthetical outcome with~     minimal cost and reduced chair time.~      The biggest issue is that high failure rate in the long term, and gray colour shining through~     the metal wing cemented onto the abutment tooth. This can compromise the aesthetical outcome.~     The aesthetical problem can be solved by the use of zirconia all ceramic material to~     construct the bridge.~   "
169484|NCT01347164|"~     Black men who have sex with men (MSM) have the highest rates of HIV infection in the United~     States and represent a population in need of new HIV prevention interventions. Although 20 to~     40% of Black MSM are estimated to have female partners, no interventions tailored to the~     needs of Black MSM/W have been developed and rigorously evaluated. This project will develop,~     implement, and evaluate an individual-level intervention (ILI), titled RISE, that will~     assist Black MSM/W to reduce their risk for acquiring and transmitting HIV infection. This~     intervention will address the effect of individual level factors, interpersonal relationships~     including sexual, peer and family relationships, and socio-cultural influences on the sexual~     risk behaviors of MSM/W. The intervention will consist of six counseling sessions held~     between a trained counselor and participant, and will be guided by three theoretical~     perspectives: an ecological perspective of behavior, stress and coping theory, and social~     cognitive theory. The COLOURS Organization, the sole agency in Philadelphia dedicated to~     exclusively serving the Black LGBT community, will be a key collaborator in the development~     and implementation of the intervention. The evaluation design utilizes a randomized~     controlled trial to test the effectiveness of the proposed intervention. Chain referral,~     based on principles of respondent-driven sampling, will be used to recruit 250 HIV-positive~     and HIV-negative Black bisexually-active men into this study.~      The specific aims of this research are to:~        -  develop a new theoretically-based individual-level HIV prevention intervention~          culturally tailored to the needs of HIV-positive and HIV-negative Black MSM/W;~        -  evaluate the intervention with a randomized control group design, using RDS to recruit~          250 Black MSM/W who do not inject drugs and who report recent unprotected sex;~        -  assess the efficacy of the intervention and test the intervention model through the~          collection of behavioral risk assessments and HIV and STD testing at three time points:~          baseline, immediately post-intervention and three-months post-intervention;~        -  examine and describe individual factors, interpersonal relationships and network~          factors, and socio-cultural factors that may affect risk behaviors for HIV infection and~          transmission among Black MSM/W;~        -  develop recommendations for recruiting Black bisexually-active men and providing them~          with targeted HIV prevention interventions.~      Evaluation data collection will be conducted using ACASI. Data analysis will include Repeated~     Measures ANOVA to make assessments of changes over time and intervention dose effects and~     structural equation modeling to assess causal associations between factors in the conceptual~     model. This proposed study has significance for increasing our understanding various types of~     factors that may affect sexual risk behaviors of Black MSM/W as well as potentially providing~     an important new tool for HIV prevention specifically targeting the needs and risk behaviors~     of Black MSM/W.~   "
169485|NCT01347151|"~     Both Glide scope and Pentax laryngoscope are video laryngoscope that provide the better view~     with minimal cervical spine movement. This study wants to compare cervical spine movement~     during intubation when using these two devices. The C-spine motion will be recorded by using~     fluoroscopic video to measure the angular displacement of the vertebrae.~   "
169502|NCT01346930|"~     The MUSIC OL study is an open-label extension study, in which all eligible patients having~     completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once~     daily. The study objective is to assess the long-term safety and tolerability of macitentan~     in patients with idiopathic pulmonary fibrosis (IPF).~   "
169503|NCT01346917|"~     The purpose of this study is to determine whether intravenous lidocaine increase the~     tolerability of early oral feeding after laparoscopic colorectal surgery in patients with~     colorectal cancer.~        -  Degree of nausea/vomiting.~        -  Degree of postoperative pain and opioids requirement.~        -  Time to first flatus, time to first stool, time to tolerance of regular diet, rate of~          postoperative complications and duration of postoperative hospital stay.~   "
169486|NCT01347138|"~     Depression in late life has been associated with losses in functioning and quality of life,~     mortality, and increased health care costs. Although late life depression can be successfully~     treated with antidepressant medication or psychotherapy, few older adults receive adequate~     trials of such treatment in community in Korea. Barriers, such as loss of loved ones, medical~     illnesses, and social stigma associated with depression, lack of social and financial~     support, to effective treatment of depression can be especially problematic for older adult.~     Screening has been valuable in overcoming barriers to diagnosis. Over 60 year old community~     dwelling people will be screened for symptoms of four geriatric conditions (depression,~     dementia, urinary incontinence, and sleep disorder). Those who will be screened positive for~     each condition will be refer to clinic for diagnosis. Among them only those cases confirmed~     as depression by psychiatrists will be enrolled in this study. Enrolled patients will be~     randomly assigned to either case management or usual care conditions.~      The objective of the study is to test whether a system of screening, assessment, and~     follow-up provided by case manager improves in recognizing the target geriatric conditions~     (depression, dementia, urinary incontinence, and sleep disorder) and healthcare outcomes.~   "
169487|NCT01347125|"~     This study is designed to evaluate the ImCardia safety and to demonstrate system~     functionality in patients undergoing AV replacement with respect to 36 months follow up.~   "
169488|NCT01347112|"~     Alcohol dependence is a significant and prevalent public health problem affecting~     approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively~     seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the~     high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high risk~     for both morbidity and mortality related to alcohol consumption and tobacco dependence.~     Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering~     alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently~     drinking alcoholic smokers.~      Varenicline is the most effective medication currently available for treating tobacco~     dependence. While some randomized trials have included recovering alcoholics, active~     alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the~     first such clinical trial in currently drinking alcoholic smokers. In addition to helping~     smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in~     rats. The goal of this proposal is to explore the potential efficacy of varenicline for~     treating tobacco dependence and reducing drinking among alcohol dependent smokers.~      The investigators hypothesize that 12 weeks of treatment with varenicline, a partial~     nicotinic acetylcholine receptor agonist will be more effective than placebo in treating~     tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic~     smokers. The investigators will also explore whether varenicline has an effect on drinking~     behavior among currently drinking alcoholics. The investigators propose the following~     specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited~     at the Mayo Clinic in Rochester, Minnesota.~   "
169489|NCT01347099|"~     Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder~     (OCD) but there is a lack of properly trained CBT therapists. One possible treatment~     alternative is Internet-based CBT (ICBT) with minimal therapist input. The aim of this study~     was therefore to evaluate ICBT for OCD.~   "
169490|NCT01347086|"~     The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and~     Caucasian healthy male volunteers administered BI 207127 NA.~   "
169491|NCT01347073|"~     This non-randomized, open-label study was approximately one year in duration and consisted of~     a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a~     12-month long term treatment period involving monthly visits.~   "
169492|NCT01347060|"~     The objective of this study is to compare healthcare utilization and costs in~     Medicare-eligible asthma patients (aged >65) who receive fluticasone propionate/salmeterol~     xinafoate combination or inhaled corticosteroids in a typical clinical practice using a~     retrospective observational cohort study design of large managed care database. Outcomes on~     interest include asthma related severe exacerbations defined as asthma related emergency~     department visits, hospitalizations or combined emergency department/hospitalization. Other~     outcomes of interest include use of albuterol, oral corticosteroids and overall asthma~     related costs. Outcomes of interest will be compared between the two treatment cohorts~     (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids).~     Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox~     regression hazards analysis assessing time to first event for each asthma related endpoint~     adjusting for differences in baseline demographics such as age, gender, previous asthma~     medication use, co morbidities, costs, and plan demographics. Total asthma related costs will~     also be compared using generalized linear models adjusting for baseline differences.~   "
169493|NCT01347047|"~     1. Creating a population-based registry system Amyloidosis prospective epidemiological~          survey~             -  risk factors~             -  diagnosis~             -  prognosis~             -  treatment~             -  monitoring~             -  survival~        2. Describe the occurrence of amyloidosis in the population of HIBA, Hospital Italiano de~          Buenos Aires.~        3. Describe the characteristics of clinical presentation, evolution and predisposing~          factors of amyloidosis.~   "
169494|NCT01347034|"~     The purpose of this study is to determine if injection of the participant's our own immune~     related white blood cells (called dendritic cells) into their tumor will strengthen their~     immune system to fight against their cancer.~   "
169495|NCT01347021|"~     The purpose of this study is to compare the vaginal sacrospinous colpopexy and high~     uterosacral colpopexy in the treatment of genital prolapse grade III/IV in women with uterus.~   "
169496|NCT01347008|"~     Early phases of systemic sclerosis is characterized by inflammatory and microvasculature~     alterations. Sildenafil citrate has been shown to have vasodilatory effects and to enhance~     vasculogenesis. The purpose of this study is to evaluate the effect of sildenafil citrate on~     hand blood flow of patients with systemic sclerosis, using Laser Doppler Imaging.~   "
169497|NCT01346995|"~     The purpose of this study is to evaluate the effects of experimental knee pain on the muscle~     strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized~     that experimental knee pain will reduce the muscle strength gain following strengthening~     exercises in healthy volunteers.~   "
169498|NCT01346982|"~     This is a clinical trial to characterize drug interactions between silimarine and the~     protease inhibitor darunavir/ritonavir.~   "
169499|NCT01346969|"~     The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing~     skin scarring in subjects undergoing revision of scars from prior surgery. The study will~     also evaluate the safety and tolerability of EXC 001 and placebo.~   "
169500|NCT01346956|"~     Twenty healthy smokers will be subjected to measurement of Pulse, Blood Pressure,~     electrocardiogram (ECG) and Echo at baseline and after smoking a cigarette. The measurements~     will be compare for any cardiovascular effects of a cigarette smoking on these parameters.~   "
169504|NCT01346904|"~     Glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across~     optic nerves, visual chiasm, lateral geniculate nucleus (LGN) and finally the visual cortex;~     the neural degenerations could be identified through the whole visual tract, which suggests~     the central nerve system may play a vital role in the progression of glaucoma. The~     investigators used MRI to investigate changes of visual pathway in vivo.~   "
169505|NCT01346891|"~     The purpose of this study is to detect if there are any differences in the coding region of~     SLC12A3 gene in individuals who have had hyponatremia associated to the use of thiazides, and~     those thiazides consumers without hyponatremia that have demonstrated good tolerance to the~     drug.~   "
169506|NCT01346878|"~     This study aims to analyze the association between the baseline detection of resistance~     mutations through Ultra deep Sequencing (UDS) and the virological outcome of salvage~     antiretroviral therapy, in comparison with conventional genotypic resistance tests. Based on~     the data generated in this study, new resistance interpretation tools and algorithms will be~     developed to improve the prediction of antiretroviral therapy outcomes. The final aim of the~     study is to improve the clinical care of HIV-1-infected patients through the incorporation of~     improved new antiretroviral resistances tests in the clinical practice.~   "
169507|NCT01346865|"~     The DECREASE-PCI trial is a prospective, randomized, placebo controlled, double-blind, phase~     4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual~     antiplatelet therapy in patients treated with DES for Coronary Artery Disease.~      The primary objective of this study is to compare the safety and efficacy of triple~     antiplatelet therapy versus dual (standard) antiplatelet therapy in patients treated with~     drug-eluting stent (DES) implantation for the treatment of coronary artery disease.~   "
169508|NCT01346852|"~     The purpose of this study is to assess the predictive ability of three asthma risk markers:~     the ratio of controller medication to total asthma medication, an albuterol only marker, and~     an oral corticosteroid use marker, as well as to compare the precision of these tools between~     adult and pediatric patient populations. This retrospective longitudinal analysis will use 2~     different databases: a large managed care database and a large fee for service Medicaid~     database.~   "
169509|NCT01346839|"~     Diagnostic delays in ambulatory care are often due to breakdowns of related care processes.~     Electronic systems can improve follow-up and reduce delays by detecting missed appointments~     or incomplete procedures so that patients are called back to conduct timely investigations~     when appropriate. To achieve high standards of patient safety in cancer diagnosis, the~     investigators not only need to use information technology appropriately but also improve the~     processes, policies, and procedures of monitoring, communication, and coordination of care.~      Given the importance of cancer-related diagnostic delays in ambulatory care, the~     investigators need effective methods to detect them, understand their causes, and intervene~     to reduce them. Manual techniques to detect these delays, such as spontaneous reporting and~     random chart reviews, have limited effectiveness. Our proposed study focuses on testing~     methods to proactively identify delays using certain triggers as they occur and intervene~     in a timely manner.~   "
169510|NCT01346826|"~     This study aims to test the hypothesis that the accelerated infusion of infliximab is not~     inferior to the conventional 2 hour infusion with respect to the frequency of infusion~     reaction.~   "
169511|NCT01346813|"~     Sick or premature neonates are exposed to frequent painful and stressful procedures during~     their stay in neonatal intensive care units. Although neonates do feel pain and may have long~     term effects induced by painful experiences, prevention and treatment of neonatal pain is far~     from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal and~     pediatric intensive care units in France in 2005 showed that painful procedures were~     extremely frequent and that analgesics treatments varied a lot among units. Since many~     guidelines have been issued by international scientific societies to manage neonatal pain,~     one may expect that the prevention and treatment of neonatal pain has improved over the last~     6 years.~      Although awake endotracheal intubations are extremely difficult or impossible in older~     children or adults, such intubations are still frequently performed without~     sedation/analgesia in neonates. Recent studies have shown that premedications facilitate~     intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed~     at assessing the risks and benefits of different sedations/analgesia strategies are urgently~     needed in neonates. We also need a tool to assess at the same time the technical conditions~     of intubations and the tolerance of the neonate to the procedure so that data from different~     studies can be compared.~      The objectives of the present study are:~        1. To describe the incidence of painful and stressful procedures performed in the neonate~          in intensive care units as well as in neonates transported by the medical emergency~          system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study~          conducted in the same region and same type of population in order to assess the~          evolution of practices. The description of painful and stressful procedures will be~          completed with a real-time around-the-clock assessment of the pain induced by procedures~          using a validated behavioral pain scale.~        2. To link this study with The Epipage study 2 in order to look for associations between~          the number of painful and stressful procedures and/or analgesic treatments of the~          neonatal period and the neurological outcome of children that will be followed in the~          Epipage cohort. The Epipage study is a separate study that will follow for 13 years a~          cohort of premature neonates recruited in 2011.~        3. To describe the incidence of painful or stressful procedures and analgesic treatments in~          neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France~          region in France.~        4. To obtain initial validity of a tool permitting to assess intubations in neonates. An~          observational detailed description of endotracheal intubations conditions will be~          conducted in neonates transported and intubated by SMUR and in neonates intubated in~          intensive care units~        5. To describe continuous sedation and analgesia practices in ventilated neonates in~          intensive care units. For these neonates, data from medical records will be recovered up~          to 2 months of admission in intensive care units~        6. To describe the frequency of heel sticks for glycemia measurement and blood gazes~          practices among centers. Relate heel stick practices to the normality or abnormality of~          glycemia results~   "
169512|NCT01346800|"~     HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit~     multiple known risk factors for CVD. Of specific concern is the fact that use of the non~     nucleosidic reverse transcriptase inhibitors (NNRTI) and/or protease inhibitors (PI) drug~     classes is associated with dyslipidemia known to increase the risk of coronary heart disease~     particularly among older subjects with normalized CD4 cell counts and suppressed HIV~     replication. HIV patients could thus potentially receive anti-aggregant therapy concomitantly~     with their antiretroviral treatment. Prasugrel is an anti-aggregating agent indicated to~     prevent the recurrence of ischemic events after coronary arteries stenting. It is a pro-drug~     mainly metabolized by cytochromes P450 (CYP) 3A and 2B6 and to a lesser extent by CYP2C9 and~     2C19. Ritonavir is an anti-protease and CYP3A4 and CYP2B6 inhibitor used in anti-HIV therapy.~     The aim of the present study is to assess the potential drug-drug interaction between~     prasugrel and the CYP3A/2B6 inhibitor ritonavir. Ten healthy volunteers will receive~     prasugrel 10mg alone or after 100mg ritonavir. The effect of ritonavir on prasugrel~     pharmacokinetics will be assessed. The two sessions will be separated by a one-week wash~     out period. During each session, CYP3A, 2B6, 2C9 and 2C19 activities will be assessed by a~     micrococktail approach with microdoses of midazolam, bupropion, flurbiprofen and omeprazole.~     The pharmacokinetics of prasugrel active metabolite will be assessed during the two sessions.~   "
169513|NCT01346787|"~     The purpose of this study is to determine whether the association of Carfilzomib,~     Cyclophosphamide and Dexamethasone (CCd) as induction treatment is safe and provides benefits~     in patients with newly diagnosed Multiple Myeloma (MM).~   "
169514|NCT01346774|"~     Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter~     associated urinary tract infection (CAUTI) in the post operatory period, as bladder~     catheterization is a common practice in gynecologic surgery. Cranberry products provide~     alternative means for preventing CAUTI and could result in decreased use of antimicrobials.~     In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to~     take either cranberry powder capsules or placebo powder capsules. The low risk of harm~     associated with using cranberry to reduce UTI coupled with its potential benefit makes it a~     desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot~     /feasibility study will prepare us for the conduct of a large scale clinical trial.~   "
169515|NCT01346761|"~     Individuals living in geographically underserved areas encounter considerable barriers to~     access of quality cancer genetic services. Although in-person genetic counseling has~     generally been accepted as the standard of care, the use of telecommunications to deliver~     clinical genetic services may help reduce this disparity in access to such services. However,~     before the widespread adoption of telephone-delivered cancer genetic services occurs, it is~     critical to analyze the efficacy and safety of this mode of communication. This two-group~     randomized equivalency/non-inferiority trial will determine whether telephone-based cancer~     genetic counseling is an acceptable alternative to the traditional in-person mode among women~     who have a personal or family history of breast and/or ovarian cancer strong enough to~     warrant genetic counseling and testing. This study's findings will provide important~     information to cancer centers and cancer control policies about the safety, efficacy, and~     costs of delivering telephone-based clinical cancer genetic services for geographically~     challenged women at risk for having Breast Cancer susceptibility gene (BRCA) 1/2 mutations.~   "
169516|NCT01346748|"~     Delayed ischemia caused by cerebral vasospasm remains a common cause of morbidity and~     mortality after aneurysmal subarachnoid hemorrhage. A great deal of drugs has been tested in~     the last years. Phase II randomized clinical trials have demonstrated that statin decreases~     the incidence of symptomatic cerebral vasospasm after spontaneous subarachnoid hemorrhage.~     Clinical, double blind, randomized controlled trials with placebo. Discussion: Even though~     some articles have shown that statins provide better prognosis, some issues remain in debate,~     e.g., treatment duration and the choice of the statin.~   "
169517|NCT01346735|"~     Most literature on ICU infections and the resistant patterns comes from the western~     literature. This data may not truly reflect the incidence, epidemiology and resistance~     patterns in developing countries such as India. However, empiric antibiotic therapy is~     generally initiated using western guidelines. This can potentially lead to inadequate,~     inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian~     setting. Hence in this multi-center observational study, we seek to:~        1. To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India~        2. To explore the microbiology, resistance and treatment patterns of these infections~   "
169518|NCT01346722|"~     It is well documented that zinc supplementation to low-income population results in the~     reduced incidence of childhood diarrhoea and pneumonia, and improves growth of stunted~     children. Implementation of large scale programmes are needed for prevention of zinc~     deficiency in areas where it is common. In Bangladesh, the risk of zinc deficiency is~     considered to be high and children could benefit greatly by improving their zinc intakes on a~     daily basis. Zinc supplementation at a national scale would be a formidable task and even if~     implemented might not be sustainable in the long range. There thus is a need to find an~     alternative. It might be sustainable to improve intake of zinc through fortified staples,~     e.g. rice with increased amounts of zinc; in fact such biofortified rice has been developed~     through conventional breeding, which is designed to contain an amount of zinc that could meet~     at least 40% of the daily requirement.~      To assess the potentials for biofortified rice in providing a good, bioavailable source of~     additional zinc, the investigators propose to measure zinc absorption from rice-based meals~     among Bangladeshi preschool children. Specifically, the investigators will measure the amount~     of zinc absorbed from zinc-biofortified rice (Diet-ZBfR, 24 mg Zn/kg), compared to that~     absorbed from a conventional Bangladeshi rice (Diet-CR, 16 mg Zn/kg) (control). The~     investigators will also compare the zinc absorption from biofortified rice with that from~     zinc-fortified conventional rice (Diet-CR+Z). The study will be a cross-over, randomized,~     controlled clinical study. In total, 42 children aged 36-59 months of either sex will be~     recruited from a peri-urban community in Dhaka, and they will be individually randomized, in~     equal numbers, to one of the two comparison groups, A and B. The group A children will~     receive zinc biofortified rice-based diet (Diet-ZBfR) and conventional rice-based diet~     (Diet-CR) using a randomized, cross-over design. Similarly, the group B children will receive~     zinc biofortified rice-based diet (Diet-ZBfR) and a zinc fortified rice based diet~     (Diet-CR+Z), also using randomized, cross-over design. The investigators will use zinc stable~     isotope tracer techniques to measure the fractional absorption of zinc, in which tracer :~     tracee ratios will be measured in spot urine samples following administration of an~     intravenously administered tracer (68Zn) and one of two oral tracers (70Zn, 67Zn) provided~     with test meals over a two-day period. If zinc from biofortified rice is found to be~     adequately bioavailable, it will be tested in a randomized, controlled, efficacy trial among~     rural Bangladeshi children.~   "
169519|NCT01346709|"~     Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe~     (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort of~     patients undergoing a nonobstetric in-hospital surgical procedure under general or regional~     anaesthesia during a continued 7-day period of recruitment.~   "
169520|NCT01346696|"~     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 6 mm~     implants in a Chinese population by evaluation of marginal bone level alteration, implant~     stability and implant survival in the posterior mandible and maxilla up to 3 years after~     loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the~     posterior region is safe and predictable.~   "
169521|NCT01346683|"~     To investigate the clinical efficacy of Osseospeed™ TX implants in a Chinese population by~     evaluation of marginal bone level alteration, implant stability and implant survival in the~     posterior mandible up to 3 years after loading. Hypothesis: Early loading of the posterior~     mandible is a safe and predictable procedure.~   "
169522|NCT01346670|"~     The objective of the study is to evaluate the relative bioavailability of lovastatin and its~     ß-hydroxy acid of 600 mg LipoCol Forte® Capsules compared to that of one 20 mg Mevacor®~     Tablet after single oral administration in healthy subjects using a 2x2 crossover design.~   "
169523|NCT01346657|"~     The objective of the study is to evaluate the effect of LipoCol Forte® Capsules on the~     pharmacokinetics of nifedipine after administering single-dose combination to healthy~     subjects using a 2x2 crossover design.~   "
169524|NCT01346644|"~     In the last years manipulation of intestinal microbiota with probiotics has gained an~     increasing interest, specially in infant nutrition since recent studies has demonstrated the~     presence of probiotics in human milk. However, there are few studies studying the effects of~     probiotics in newborns. The objective of the present study is to analyze safety and tolerance~     of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.~   "
172606|NCT01305837|"~     The purpose of this study is to determine whether cyclic oral methylprednisolone once every~     month has an effect on the intrathecal inflammation in patients suffering from progressive~     multiple sclerosis.~   "
169525|NCT01346631|"~     Prospective studies concerning diet and male fertility are lacking. Observational studies~     suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm~     counts. The investigators wanted to see if a paleolithic diet consisting of meat, fish,~     fruits vegetables and nuts and lacking grains, legumes and dairy products can improve sperm~     counts.~   "
169526|NCT01346618|"~     Bone age assessment is currently an important tool in final height implication in children.~     It is an important tool in the phases of investigation and treatment of short stature, tall~     stature, pubertal timing and various endocrinological pediatric situations. It is currently~     assessed using hand x-ray. This method has several limitations, including: requirement of~     specialized medical staff to interpret results, exposure radiation and usage of equipment~     which is only in radiology centers. The investigators aim to study a new equipment, radiation~     free, with simple and swift operation which provides an immediate answer, no need for an~     experienced observer, a mobile equipment with easy accessibility. The aim of the study is to~     assess its reproducibility, validity and safety compared to the x-ray method.~      The investigators hypothesize it is as accurate and valid.~   "
169527|NCT01346605|"~     This protocol describes a study whose goal is to collect de-identified Cardiac CT Perfusion~     (CTP) acquisition parameters and clinical findings from approximately 20 qualified medical~     facilities. The study uses an electronic data capture tool to collect the de-identified data~     to create a global multi-center registry. This registry will be used for scientific analysis~     and publication of pertinent medical trends such as CT utilization, radiation dose, and~     common cardiovascular findings.~   "
169528|NCT01346592|"~     This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted~     Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza~     Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to <~     72 Months of Age.~   "
169529|NCT01346579|"~     This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit~     alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast~     cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory~     may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and~     identify biomarkers related to cancer.~   "
169530|NCT01346566|"~     The purpose of this study is to report the intraoperative performance and postoperative~     outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated~     lenses.~   "
169531|NCT01346553|"~     The External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous~     Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way~     venous valve and a sensor that identifies the movement of the calf muscles pump. The external~     device is located above the failed deep vein and exerts synchronized intermittent regulated~     pressure on it. Alteration in the vein structure is occurred and the blood flows in the~     cephalad direction, preventing the return toward the feet. The device is synchronized with~     the calf muscles pump to function as a one-way venous valve. This study was design in order~     to assess safety and efficacy of using the ESVV for treatment of consequences of deep chronic~     venous insufficiency.~   "
169532|NCT01346540|"~     The LUME-Lung3 study is in 2 parts:~      Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that~     can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and~     cisplatin.~      Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles~     of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2~     previous courses of the chemotherapy~   "
169533|NCT01346527|"~     Background: The health of the next generation is likely programmed in the womb (i.e.in~     utero), and our understanding of how that programming happens will allow us to favorably~     influence the health of future generations. The focus of this proposal is to examine the~     effect of in utero programming on heart function in children born to women with type 2~     diabetes (T2DM). Specifically, neonates born to diabetic women have abnormal heart structure~     and weaker heart function at birth, which may predispose them to long-term heart problems in~     childhood, adolescence and adulthood. At present, the reason for these heart abnormalities in~     children born to women with diabetes is unknown and is the focus of this proposal.~      Objective(s) and Hypothesis(es): The objectives are to examine the relationships among~     maternal lipid (fatty acid, triglyceride, very low density lipoprotein) metabolism and~     neonatal heart structure and function in diabetes and to identify clinical markers during~     pregnancy for heart dysfunction in infants born to diabetic women. The overall hypothesis is~     that maternal lipid metabolism is abnormal in diabetes, and this metabolic dysregulation~     increases fatty acid delivery to the fetus in utero and leads to abnormal accumulation of~     lipid in the fetal heart, resulting in altered neonatal heart structure and function in~     infants born to diabetic women. In addition, the investigators hypothesize that decreased~     maternal fatty acid oxidation (fat burning) rate, elevated lipolytic (fat breakdown) rate~     and elevated blood total free fatty acid level predicts abnormal neonatal heart structure and~     function in infants born to women with type 2 diabetes.~      Methods and Procedures: The investigators will test these hypotheses by using clinical~     metabolism studies (infusion of stable isotope labeled fatty acid, serial blood and breath~     sampling, and mass spectrometry) to quantify whole-body fat (fatty acid oxidation, lipolysis,~     and serum fatty acid , triglycerides, VLDL-cholesterol levels) metabolism in 25 diabetic~     women during the 3rd trimester of pregnancy, and compare these lipid metabolism kinetics to~     25 body mass index matched healthy non-diabetic women during pregnancy and determine if~     alterations in maternal lipid metabolism predict abnormal neonatal heart function in children~     born to these women.~      Potential Impact: Type 2 diabetes is an epidemic in the United States and is steadily~     increasing worldwide. Diabetes has detrimental health effects in pregnant women and in their~     offspring. The investigators know that children born to women with diabetes have an increased~     risk for developing diabetes, obesity and cardiovascular disease, than children born to~     healthy women. This proposal will address an important knowledge gap regarding the role of~     maternal lipid (and potentially other nutrients) metabolism on the cardiovascular health of~     the global and increasing population of children born to diabetic women. Findings from this~     project will be novel and innovative, and will likely point to clinical interventions that~     target and correct lipid and other metabolic abnormalities in women with pre-gestational~     diabetes. The impact will be great because the long-term goal is to ameliorate heart problems~     in children born to diabetic (both pre-gestational and gestational) women. In addition, this~     project will establish a small cohort of children that can be followed long-term to address~     novel questions about the progression of heart and other metabolic abnormalities in children~     born to diabetic women.~   "
169534|NCT01346514|"~     The study examined intensive case management for homeless Veterans in addiction treatment by~     integrating addiction/housing case managers (AHCM), operating from a Life Skills Training~     perspective, into an addiction specialty program. The primary aim was to determine whether~     the AHCM intervention increases number of days housed during the year following treatment~     entry. Secondary aims were to compare costs and cost-effectiveness of AHCM vs. time and~     attention control, determine if AHCM improves addiction outcomes and functional status, and~     examine treatment process variables associated with improved outcomes.~   "
169535|NCT01346501|"~     The main objective of this study was to determine the ability to maintain response after~     discontinuation of adalimumab treatment and the secondary objective was to determine~     radiographic progression in participants participating in the study, including the percentage~     who displayed minimal progression.~   "
169536|NCT01346488|"~     This is a single-arm, multi-center, prospective cohort study (post-marketing observational~     study). The observation period for each participant is 48 weeks.~      This study is designed to provide additional data on treatment effects of adalimumab during~     48 weeks of treatment in patients with RA under conditions of routine rheumatology care.~     Course of work productivity and work ability, the course of health-related quality of life,~     and changes in functionality during 48 weeks treatment with adalimumab are to be documented.~   "
169550|NCT01346306|"~     Among antidepressant treatments, ECT stands as the most effective in treating acute~     depression. However, patient concerns with the cognitive side effects of ECT have encouraged~     the development of new and more focal forms of brain stimulation such as transcranial Direct~     Current Stimulation (tDCS). However, not all patients may respond to this treatment in the~     way that it is currently administered and this has raised interest in finding alternative,~     possibly more optimal ways of administering tDCS. This study will investigate whether tDCS~     stimulation using an alternative electrode montage has antidepressant effects. Further~     sessions of tDCS, spaced less frequently, will be trialed for maintenance treatment. Mood,~     cognitive test performance and biomarkers will be measured periodically in the duration of~     the trial.~   "
169589|NCT01345786|"~     For the contraceptive application a film-coated tablet has been developed which combines~     nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized,~     single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at~     two sites, one site per study part. The primary objective of Part 1 was to assess the~     bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process~     (commercial batch) versus the Phase 3 drug product (Batch A). The primary objective of~     Part 2 was to assess bioequivalence of NOMAC and E2 of the drug product manufactured using~     the commercial process (commercial batch) versus the Phase 3 drug product (Batch B).~   "
169537|NCT01346475|"~     On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to~     NCT00362297. On 28 April 2011, the two records were split for administrative purposes and~     each trial was given its own unique study record. Please refer to the History of Changes on~     posting NCT00362297 for a detailed summary of the modifications.~      The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir~     compared to once daily valacyclovir for reduction of asymptomatic HSV-2 genital shedding in~     persons with genital herpes.~      The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by~     blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at~     least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and~     willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females~     only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an~     effective form of birth control.~      Involvement in the study will last 11-weeks and you will be asked to visit the clinic every~     2-weeks. At each visit, you will be given medication to take daily (either once daily~     valacyclovir or high dose valacyclovir; you will receive both medications at some point~     during this study). We will ask you to give a blood sample for liver, kidney and blood count~     testing at each visit. There will be a total of 8 study visits and each visit will last~     approximately 30 minutes. We will ask that you complete a daily symptom diary and collected~     daily home swabs 4-times a day, everyday during the study. Each daily home swab will take~     less than 3 minutes to perform.~   "
169538|NCT01346462|"~     The investigators propose a pilot randomized controlled trial of a care transitions~     intervention in which trained Community Health Workers will act as supports for~     socioeconomically vulnerable patients who are being discharged from the Hospital of the~     University of Pennsylvania and Presbyterian Hospital. CHWs or IMPaCT Partners will help~     patients to overcome the challenges of transition, including arranging primary care provider~     (PCP) follow-up, filling medication prescriptions and obtaining referrals to community-based~     social services. As our primary outcome, the investigators will examine the effect of the~     IMPaCT intervention on rates of primary care follow-up. The investigators will also examine~     the effect of IMPaCT on secondary outcome variables including patients' satisfaction with the~     experience of transition, quality of discharge communication, medication adherence, self-~     rated health, and inpatient readmission within 30 days after discharge.~   "
169539|NCT01346449|"~     The purpose of the study is to better understand how individuals make decisions regarding the~     meals they order. Participants' ordering decisions at lunchtime at a chain restaurant will be~     recorded over several weeks to study ordering habits over time. Lunch menus will be provided~     by the study, and the menu format will vary the way in which information on caloric content~     is displayed.~      The impact of different labeling formats on total calories in the chosen meal will be~     assessed.~   "
169540|NCT01346436|"~     The purpose of this randomized double blind controlled study is to assess the value of~     robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare~     perioperative and functional outcomes to the laparoscopic approach.~   "
169541|NCT01346423|"~     Musculoskeletal pain is very common in the normal population, and the reason for about 50 %~     of the long term sickness absence in Norway. Most of these patients have common, but~     troublesome subjective health complaints where pathological findings are absent or~     substantially less than expected compared to the reported intensity of the complaints.~     Psychosocial factors are important in the development of chronic complaints. In a large~     meta-analysis job satisfaction was found to be associated with mental health and subjective~     physical health. Individual factors are also important. Uncertainty related to the~     understanding of pain mechanisms, treatment strategies and management contribute to the~     problem.~      Among patients sicklisted for musculoskeletal complaints, low back pain is the largest~     diagnose group. Most of these patients also have many other complaints. Previous studies have~     shown that for low back pain patients a brief intervention at a spine clinic with~     examination, information, reassurance, and encouragement to engage in physical activity as~     normal as possible, had significant effect in reducing sick leave. Other studies have shown~     that multidisciplinary rehabilitation for chronic low back pain has effect on sick leave. A~     Danish study from Arbeidsmiljøinstituttet report that interdisciplinary treatment for~     patients sicklisted for musculoskeletal complaints, had effect on socio-economic costs, pain,~     and function.~      A treatment team consisting of various professionals is expensive, and in this study we will~     compare the simple, standardized brief intervention model with the more resource demanding~     interdisciplinary treatment for patients sicklisted for musculoskeletal complaints.~      Research question / hypothesis: An interdisciplinary treatment model for musculoskeletal~     complaints - is it beneficial for reducing sickness absence?~   "
169542|NCT01346410|"~     This study will evaluate the local control rate as well as acute and late toxicity rates of~     stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.~   "
169543|NCT01346397|"~     After alemtuzumab induction, followed with kidney transplantation, patients will be randomly~     assigned to receive either tacrolimus or cyclosporine microemulsion in combination with~     mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month~     posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr~     virus (EBV) and BK virus (BKV) in urine and blood.~      The investigation is undertaken to clarify the reason for equal survival rates for patients~     on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.~   "
169544|NCT01346384|"~     The purpose of this study is to investigate the time-related intracuff pressure and volume~     change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.~   "
169545|NCT01346371|"~     The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye~     drop on the quality of your tears.~   "
169546|NCT01346358|"~     A dose escalation study to establish the safety profile and characterize the pharmacokinetic~     profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to~     standard therapy or for which no standard therapy is available.~   "
169547|NCT01346345|"~     Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary~     laterals and mandibular incisors~   "
169548|NCT01346332|"~     The study will recruit healthy volunteers to undergo the iontophoresis procedure using the~     Acclarent Iontophoresis System with Headset.~   "
169549|NCT01346319|"~     Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of~     testosterone in hypogonadal males.~   "
169570|NCT01346046|"~     The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of~     subjects who have been diagnosed with Type 2 diabetes.~   "
169571|NCT01346033|"~     The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of~     subjects who have been diagnosed with Type 2 diabetes.~   "
173358|NCT01295918|"~     The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus~     reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections~     in children and adolescents.~   "
169551|NCT01346293|"~     The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® +~     IPOL® as the 5th dose booster in children ≥ 4 to < 7 years of age in the US and Puerto Rico~     who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only.~      Primary Objectives:~        -  To compare the pertussis [Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA),~          Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)] booster responses and geometric mean~          concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay [ELISA])~          following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination~          when administered as a 5th dose.~        -  To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA)~          following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL®~          vaccinations when administered as a 5th dose .~        -  To compare the Inactivated Poliovirus Vaccine booster responses (as measured by~          neutralizing assay) following DTap-IPV vaccination with those elicited following~          DAPTACEL® + IPOL® vaccinations.~      Observational Objectives:~        -  To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV~          vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.~        -  To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered~          as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL~          and/or Pentacel vaccines.~   "
169552|NCT01346280|"~     Background:~      -Coordinated cancer care provided by doctors, nurses, social workers, and other care~     providers is believed to improve patient and physician satisfaction and patient evaluation~     for enrollment in clinical trials. But no research has been done to show that this approach~     improves patient experiences and outcomes. Researchers want to study this model to better~     understand how it can improve cancer treatment and patient outcomes.~      Objectives:~      - To assess the relationship between coordinated care and cancer treatment processes and~     outcomes.~      Eligibility:~      - Individuals who are at least 18 years of age. Those who take part must have been diagnosed~     with colon, rectal, or non-small-cell lung cancer. They also must be receiving or have been~     treated at one of the 16 NCI Community Cancer Center program sites.~      Design:~        -  Researchers will collect medical records data from participants.~        -  Participants will complete a questionnaire about 8 weeks after the end of all planned~          cancer treatment. They will be asked questions about their experience with coordinated~          cancer care. They will also be asked for any comments or concerns they had during and~          after treatment.~        -  No treatment or additional tests will be provided as part of this protocol.~   "
169553|NCT01346267|"~     RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It~     is not yet known whether standard care is more effective with or without acupressure~     wristbands in controlling acute and delayed nausea.~      PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work~     with or without standard care in controlling nausea in young patients receiving highly~     emetogenic chemotherapy.~   "
169554|NCT01346254|"~     Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious~     complication after kidney transplantation. Patients who develop NODAT are at increased risk~     for loss of the transplanted organ and for diseases of the cardiovascular system.~      It is believed that in many patients the development of overt NODAT is preceded by a phase of~     impaired glucose tolerance that is called pre-diabetes.~      This study aims at improving glucose metabolism in patients after kidney transplantation who~     are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT)~     after kidney transplantation are randomized to either receive vildagliptin (Galvus),~     pioglitazone(Actos) or placebo for three months.~      The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to~     improved glycemic control compared to placebo.~   "
169555|NCT01346241|"~     The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA~     community based outpatient clinics (CBOCs).~   "
169556|NCT01346228|"~     The purpose of this study is to see if a new Smart Phone application can help Veterans manage~     their panic symptoms after completing a two-day treatment for panic attacks.~   "
169557|NCT01346215|"~     The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect~     and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.)~     compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under~     hemodialysis treatment.~   "
169558|NCT01346202|"~     Complex and chronified pain syndromes requires a specialized therapeutic concept. From~     patients with chronic low back pain the investigators know, that an interdisciplinary~     multi-modal approach may improve the therapeutic success. In this observational study the~     investigators investigated if the multi-modal pain therapy is also effective in patients with~     mixed chronic pain syndromes.~   "
169559|NCT01346189|"~     Using a 4-arm, cluster-randomized controlled trial, the investigators will test the~     effectiveness of different behavioral economic interventions in increasing statin use and~     reducing LDL cholesterol among patients with poor cholesterol control who are at very high~     risk for CVD. The investigators will test these approaches among primary care physicians and~     their patients at very high risk of CVD at Geisinger Health System and University of~     Pennsylvania outpatient clinics.~   "
169560|NCT01346176|"~     The investigators aim to assess the influence of default options in advance directives on~     older patients selections of life- extending therapies and to determine whether alerting~     patients to the spectrum of possible default options in advance directives influences their~     selections of life-extending therapies by manipulating the default options of advance~     directives given to patients in with severe respiratory disease~   "
169561|NCT01346163|"~     This study will look at the impact of dosing as well as ongoing treatment with an~     investigation medication identified as PF-03654746, on cognitive and physiologic indicators~     of brain function. Data from this study will assist with the evaluation of the utility of~     functional magnetic resonance imaging, arterial spin labeling (ASL), and electrophysiologic~     measures in the detection of early signals of the effectiveness of medications developed to~     target cognitive impairment in schizophrenia. Safety and tolerability of PF-03654746 in this~     population will be also be evaluated.~   "
169692|NCT01344421|"~     The purpose of this study is to examine the movement pattern in patients with hip dysplasia~     preoperative, six and 12 month after minimally invasive approach for Periacetabular osteotomy~     (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and~     historical data.~   "
169562|NCT01346150|"~     People with Primary Immune Deficiency (PID) may develop severe, life-threatening infections~     as a result of inherited defects in the genes that normally instruct blood-forming cells to~     develop and to fight infections. PID diseases include Severe Combined Immune Deficiency~     (SCID), leaky SCID, Omenn syndrome (OS), and Reticular Dysgenesis (RD). PIDs may be treated~     by transplantation of bone marrow stem cells from a healthy person or, in some cases, by~     enzyme replacement or by gene therapy. Patients with SCID were among the first to receive~     bone marrow stem cell (also called hematopoietic cells) transplantation (HCT) more than 40~     years ago, and HCT is the standard treatment today for this group of diseases. Since PID~     diseases are rare, there are not enough patients at any single center to determine the full~     range of causes, natural history, or best methods of treatment. For this research study many~     PID centers across North America have organized into the Primary Immune Deficiency Treatment~     Consortium (PIDTC) to pool their experience and study PIDs together. Researchers will collect~     information on your general health, psychological and developmental health, and the current~     status of your immune system to help better define future approaches to PID treatments.~   "
169563|NCT01346137|"~     In this study the investigators propose to evaluate a COX-2 inhibitor(meloxicam) to assess~     its effect on follicular development and find out if this regimen delays or blocks ovulation~     while maintaining ovarian cyclicity. The investigators intend to administer 15 mg or 30 mg of~     meloxicam per day for 18 days starting on day 5 after onset of menses during 3 continuous~     cycles. The 3 treatment cycles will be preceded and followed by control cycles with no~     treatment. Ovulation or lack there of will be monitored by transvaginal ultrasound~     examinations (TVUs), estradiol, luteinizing hormone (LH), and progesterone levels in multiple~     blood samples in each cycle. The investigators will recruit a total of 56 women. Each woman~     will be randomly assigned to 1 of the 2 dose regimens of meloxicam, with 28 women assigned to~     each of the 2 dose regimens. Participating women will demonstrate an ovulatory cycle before~     starting meloxicam treatment and will be protected from pregnancy by prior sterilization.~   "
169564|NCT01346124|"~     There are two types of external radiation treatments; proton beam and photon beam radiation.~     What type of therapy participants will receive will depend upon the location of their tumor.~     Standard treatment would involve receiving either proton or photon radiation delivered by a~     three dimensional (3-D) conformal radiation technique. 3-D conformal radiation therapy is a~     technique where the beams of radiation used in the treatment are shaped to match the tumor in~     order to avoid damaging the healthy surrounding tissue. Standard treatment also may include~     photon radiation delivered by intensity modulated (IMRT) technique. In this research study we~     are using an investigational technique to deliver proton radiation therapy called intensity~     modulated proton radiation treatment (IMPT) which is used to target cancer while sparing~     healthy tissue. With IMPT (and standard IMRT), radiation intensity can be turned down during~     the treatment. This control over the intensity of the radiation dose has the potential to~     provide accuracy and allows us to more safely increase the amount of radiation delivered to~     the tumor. This accuracy may potentially reduce side effects that patients would normally~     experience with 3-D proton radiation therapy. Surgery is often an important component of the~     treatment for these tumors and may be integrated with the IMPT.~   "
169565|NCT01346111|"~     The purpose of the study is to generate and valid a co-morbidity score with updated~     definitions and suitable for use in Argentina in both public and private settings. These~     tools would allow us to compare different populations in Argentina adjusting for~     comorbidities. Also, this would potentially help attending physicians and health~     administrators.~   "
169566|NCT01346098|"~     The goal of the proposal is to demonstrate that, in patients with disease of the pancreatic~     head with very high-risk of complications of pancreatojejunal reconstruction (soft pancreas~     and pancreatic duct diameter <3 mm), total pancreatectomy with islet autotransplantation~     (IAT) is associated with a lower morbidity (in terms of surgical or medical complications)~     and mortality compared with pancreaticoduodenectomy and pancreatojejunal anastomosis.~   "
169567|NCT01346085|"~     Our final objective is to develop an adoptive therapy with tolerogenic donor-specific Tr1~     cells in T1D patients undergoing pancreatic islet transplantation (Tx). The achievement of~     this objective depends by the availability of an immunosuppressive treatment (IS) compatible~     with the survival, function, and expansion of the transferred Tr1 cells. For this purpose the~     investigators design a CNI-free single-group, phase 1-2 trial excluding the ATG or anti-CD25~     induction therapy after the 1st islet infusion~   "
169568|NCT01346072|"~     This pilot study will investigate the association between levels of the peptide copeptin and~     response to tolvaptan, a drug that blocks the action of the water retaining hormone~     vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45)~     selected by targeting upper and lower quartile copeptin levels at screening (10 each). The~     treatment phase of the study will be a prospective, single-arm, open label protocol. All~     patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan~     with body weight, fluid intake, and urine output monitored in a research unit for 24 hours.~      For analysis of study endpoints, patients in the single intervention arm will be stratified~     by a prospectively determined cut-point of copeptin level into two groups (≥10 versus <10~     pmol/L). The copeptin level used for the two group stratification will be the blinded~     copeptin value obtained at baseline from the hospital phase prior to administration of~     tolvaptan.~   "
169569|NCT01346059|"~     Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in~     patients after recent antibiotic use. The current standard of care treatment for severe C.~     diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is~     unsuccessful, it can lead to need for removal of the entire colon or even death. In fact,~     mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted~     mortality rate is 14% for severe infection. It is believed that the failure of treatment may~     stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral~     vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin~     functions by direct contact with the colon. Therefore, if the vancomycin is instilled~     directly into the colon, it can come into contact with and be its intended target. : The~     objective of the study is to improve treatment of severe C. diff. colitis . C. diff.~     infection is defined as severe if there is evidence of ileus accompanied by any one of the~     following: fever greater than 38.30C, , acidemia, serum albumin less than 2.5, or white blood~     cell count greater than 14,000.~   "
169572|NCT01346020|"~     This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using~     different approaches and to identify a possible association with disease progression, i.e.~     therapy initiation.~        1. Samples This monocentric study is carried out using representative bioarchived leukemic~          samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived~          samples were collected locally at our center during years of diagnostic activity, and~          were accurately pathologically, cytogenetically and molecularly characterized.~        2. Clinical data The clinical data were retrospectively collected through collaboration~          with the referring physicians.~        3. Methods Samples will be investigated by means of (1) conventional cytogenetics, (2)~          fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the~          array data sets, significant results will be validated and in addition, results will be~          correlated with clinical data.~   "
169573|NCT01346007|"~     The purpose of this study is to determine whether 7-valent pneumococcal conjugate vaccine~     safely induces immune responses and immunological memory in children with idiopathic~     nephrotic syndrome in remission.~   "
169574|NCT01345994|"~     This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine~     how this central fMRI biomarker is modulated by acupuncture. This study will also investigate~     the behavioral consequences of maladaptive cortical plasticity in this disease population.~   "
169575|NCT01345981|"~     To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg,~     and without lidocaine.~   "
169576|NCT01345968|"~     The primary purpose of this study is to evaluate the safety and efficacy of preoperative~     intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement~   "
169577|NCT01345942|"~     This open label, two period, crossover study will evaluate the safety and the effect of food~     on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy~     subjects will be randomized to receive a single oral dose of RO5428029 with or without food,~     with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days after~     last dose. Anticipated time on study will be up to 21 days.~   "
169578|NCT01345929|"~     This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of~     CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the~     treatment of adults with a cUTI (including pyelonephritis).~   "
169579|NCT01345916|"~     The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the~     corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in~     terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.~   "
169580|NCT01345903|"~     This pilot clinical trial studies robotic-assisted surgery in treating patients with spine~     tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may~     have fewer side effects and improve recovery~   "
169581|NCT01345890|"~     The investigators aim is to try to rehabilitate post stroke dysphagia using electrical~     stimulation of the mylohyoid muscles.~   "
169582|NCT01345877|"~     Pain is a complex experience influenced by gender and genetics, and, by psychosocial and~     sensory experiences. Pain sensitivity is thus highly variable between individuals.~      In the present study we evaluate individuals´ pain perception in response to a number of~     different pain stimuli in 100 healthy volunteers (50 females and 50 males).~      The data will allow us to assess pain sensitivity, to predict pain responses and to~     investigate gender related differences in pain perception.~      A second aim is to evaluate the robustness of the different pain-tests since the tests are~     repeated with an interval of 2-4 weeks.~   "
169583|NCT01345864|"~     This study is designed to look at the potential for an investigational drug (PF-04995274,~     under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to~     reverse changes in memory and learning/problem solving skills caused by co-administration of~     a marketed drug called scopolamine. Scopolamine is known to cause temporary changes in memory~     and learning/problem solving skills that are similar to those seen in people with alzheimer's~     disease(AD).~   "
169584|NCT01345851|"~     This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given~     together with hypofractionated RT boost and combination chemotherapy in treating patients~     with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT~     uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays~     directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving RT together with~     combination chemotherapy may kill more tumor cells and allow doctors to save the part of the~     body where the cancer started~   "
169585|NCT01345838|"~     A prospective case-control study of the clinical and radiographic outcome of periacetabular~     osteotomy in patients with and without preoperative acetabular labral tears.~   "
169586|NCT01345825|"~     The purpose and Study hypotheses:~      The purpose of the study is to investigate the effect of progressive resistance training in~     the early postoperative phase on patients who has had unicompartmental knee replacement. The~     hypotheses are that this group compared to a control group will achieve greater muscle~     strength and functional ability in terms of gait and working capacity.~      Study design:~      The subjects will be randomized into two groups; intervention and control. Intervention~     group: strength training two times a week supervised by a physiotherapist.~      Control group: Training at home, following extradited guidelines.~      Endpoint:~      Primary endpoint is two months postoperative. The following test will be used: muscle power~     test (by a Power Rig), instrumented gait analysis using a combined accelerometer and~     gyro-sensor in; 6 min. walk test, stair climbing test, 20 meter walking test and block step~     test.~      Furthermore, the questionnaire KOOS will be used for monitoring every 2 weeks.~      Sample size:~      The power calculation is based on an expected improvement in muscle power by 25%. The risk of~     a type 1 error is set to 5 %, and the power is set to 80%. The calculations showed that 24~     patients are needed in both groups, but 30 patient will be included in both groups to account~     for dropouts.~      Perspectives:~      This study is, to our knowledge, the first study to investigate the effect of strength~     training after unicompartmental knee replacement. Moreover it has , to our knowledge not~     been. At the moment no guidelines for rehabilitation exist, and research showed that this~     group of patients has a decreased function in their daily living compared with the background~     population. If, as expected, cases have an overall increased function compared to controls,~     this study can provide a basis for future rehabilitation.~   "
169587|NCT01345812|"~     The primary purpose of the investigation is to identify differences in embryo development~     after follicle stimulation with two different gonadotrophins.~   "
169588|NCT01345799|"~     In Crohn's Disease Patients~        -  To evaluate the efficacy of TRK-170~        -  To evaluate the PK characteristics of TRK-170~        -  To assess the safety of TRK-170~   "
169590|NCT01345773|"~     Venous thromboembolism (VTE) has considerably harmful effects on morbidity and mortality of~     cancer patients. Several guidelines recommendations have been made about the use of~     anticoagulation for the prevention and treatment of VTE in Western patients with cancer. In~     Western VTE guidelines, all solid cancer patients receiving abdominal major surgery are~     strongly recommended to receive pharmacologic prophylactic anticoagulation such as low~     molecular weight heparin (LMWH) in the perioperative periods. These guideline recommendations~     are based on high incidence of postoperative VTE development in Western cancer patients.~     However, there have been many cumulative data about the effect of different ethnicity on the~     VTE development and more and more investigators and clinicians admit that Asian ethnicity has~     lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to apply~     Western guidelines as it is to the clinical situation of Asian cancer patients.~      Although gastric cancer is the common cancer in Asia, there is no prospective data on the~     incidence of VTE development during the postoperative period of gastric cancer surgery. In~     other words, Asian doctors including Korean clinicians don't know the exact incidence of~     surgery-related VTE. From their clinical experiences, most Korean surgeons think that the~     incidence of postoperative VTE development is rare. They also have much concern about the~     complications such as bleeding that might be caused by routine use of pharmacologic~     thromboprophylaxis during the perioperative periods. Therefore, in most clinical situation,~     Korean surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW.~     Considering these clinical situations in Korea, the uncritical acceptance of Western~     guidelines is inappropriate. The necessity of pharmacologic thrombo-prophylaxis can be~     answered only from the results of the prospective study on the incidence of postoperative VTE~     development after gastric cancer surgery. Moreover, current surgical trend in cancer patients~     is minimally invasive approach such as laparoscopic surgery. However, the necessity of~     pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has not~     been evaluated even in Western countries. Western guidelines also cannot exactly answer~     whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving~     laparoscopic cancer surgery. On above backgrounds, this study was designed.~   "
169591|NCT01345760|"~     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length,~     capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs~     (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of~     complementarity. miRNAs have recently been shown to play pivotal roles in diverse~     developmental and cellular processes and linked to a variety of skin diseases and cancers. In~     the present study, the investigators examines the expression profiles of the microprocessor~     complex subunit DGCR8 and the RISC components TARBP1, TARBP2, argonaute-1, argonaute-2 and~     PACT in epithelial skin cancer and its premalignant stage.~   "
169592|NCT01345747|"~     This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV),~     end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the~     insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective~     gynecological laparoscopic surgery.~   "
169593|NCT01345734|"~     This trial is conducted in Asia. The aim of this trial is to investigate the safety profile~     of liraglutide under normal conditions of use.~   "
169594|NCT01345721|"~     The primary purpose of this study is to evaluate the persistence of bactericidal antibodies~     in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study~     who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is~     measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8~     directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the~     response one month post an additional dose of Novartis MenACWY will be measured by percentage~     of subjects with hSBA titers ≥ 1:8 and GMTs.~   "
169595|NCT01345708|"~     The aim of this prospective study was to evaluate the activity, safety and the duration of~     the response of low dose rituximab associated with standard oral prednisone as first line~     therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease,~     and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral~     prednisone. Further aim was to correlate the clinical response to biological parameters~     (cytokine and anti-erythrocyte antibody production in cultures).~   "
169596|NCT01345695|"~     This study will conduct an evaluation of the World Health Partners (WHP) private provider~     project to see if the social franchising and telemedicine project has an impact on health~     outcomes in treatment vs. control areas. The evaluation will also estimate specific~     parameters of the WHP program that can be used to maximize financial sustainability and~     replicability/scalability of the program.~   "
169597|NCT01345682|"~     This randomised, open-label, phase III study will be performed in patients with R/M head and~     neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The~     objectives of the trial are to compare the efficacy and safety of afatinib versus~     methotrexate~   "
169598|NCT01345669|"~     This randomised, double-blind phase III trial will be performed in patients with head and~     neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy~     and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have~     received definitive chemo-radiotherapy.~   "
169599|NCT01345656|"~     A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and~     randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally~   "
169600|NCT01345643|"~     Guidelines for blood transfusion have been issued for years. According to these guidelines,~     red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than~     6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the~     guidelines, the determination of whether RBCs should be administered when the hemoglobin~     level is in the range of 7~10g/dL is based on the judgment from anesthesiologists or~     surgeons. Index of transfusion trigger for patients with hemoglobin level between 7/dL and~     10g/dL is necessary and important in clinical practice. Based on the aim of blood transfusion~     that maintain the balance of oxygen supply and oxygen consumption, the investigators~     hypothesize that index of transfusion trigger for patients with hemoglobin level between 7/dL~     and 10g/dL could be calculated by their history about heart and blood pressure, and routine~     monitoring parameters including pulse oximetry, temperature, and the use of vasoactive~     medications. To verify this hypothesis, the investigators present West China Perioperative~     Transfusion Score (WCPTS) for the trigger of transfusion according to the patient's history~     and monitoring parameters, and the investigators design a randomized controlled clinical~     trial to test this score.~   "
169601|NCT01345630|"~     The purpose of this study is to assess whether maraviroc administered once daily is~     non-inferior to emtricitabine/tenofovir also administered once daily each in combination with~     darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48~     of treatment.~   "
169602|NCT01345617|"~     The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat~     chloride results that are equivalent to the results from traditional sweat testing. The~     secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum~     Sweat Test compared to traditional sweat testing.~   "
173359|NCT01295905|"~     The purpose of this study is to evaluate the performance of an investigational daily~     disposable contact lens.~   "
169603|NCT01345604|"~     his study is being done because total knee replacements can leave patients with considerable~     pain after surgery. Therefore, many studies have been done to find the best ways to control~     knee pain after the surgery. Currently, a popular approach is to use many different~     techniques to control the pain. This includes injecting freezing (local anesthetic) into the~     spinal column (spinal anesthetic), injecting freezing close to the nerves of the knee and~     using various kinds of medications (e.g. narcotics and anti-inflammatory medications).~     Studies have shown using this a combination of techniques can reduce pain and allow earlier~     discharge from the hospital. However, one downside to this approach is it does not usually~     control the pain in the back of the knee. One new technique has been used to try and overcome~     this. This technique is called a posterior cruciate ligament block or PCL block. It~     involves injecting a drug into the back of the knee which will block the nerves in this area.~     Sometimes the investigators refer to this as freezing.~      The purpose of our study is to determine whether this PCL Block will improve pain after the~     total knee replacement surgery. The investigators will also determine whether this technique~     will improve movement in the knee and lessen narcotic usage after the surgery.~   "
169604|NCT01345591|"~     Injuries resulting in facial trauma are common, and can have devastating consequences on your~     quality of life. While the facial bones can often be reconstructed, physicians strive to find~     better ways to accurately restore injured facial features.~      In this clinical trial funded by the Department of Defense, the investigators are evaluating~     how effectively fat grafting can restore facial features, and how the filling effect of the~     fat graft lasts over time in participants with visible facial injuries. All procedures for~     this research study will be performed at the University of Pittsburgh Medical Center.~   "
169605|NCT01345578|"~     The purpose of this research study is to determine whether partial irradiation of the liver~     and liver cell transplantation can provide help for patients with life-threatening~     liver-based metabolic diseases who are unlikely to survive without extensive medical therapy~     or transplant. The goal of this research study is to determine if liver cell transplants can~     be effective as an alternative to organ transplantation. At the present time, liver cell~     transplants are experimental and have been done in a limited number of human subjects.~   "
169606|NCT01345565|"~     The purpose of this research study is to determine whether liver cell transplantation can~     provide help for patients with liver failure who are unlikely to survive without some form of~     liver support. The goal of this research study is to determine if liver cell transplants can~     be effective until a liver transplant is received or until patients recover from their liver~     failure.~   "
169607|NCT01345552|"~     The purpose of this study is to evaluate feasibility of stereotactic body radiation (SRS) in~     patients with recurrent oligometastatic disease.~   "
169608|NCT01345539|"~     The purpose of this study is to evaluate feasibility of radiosurgery for all metastatic sites~     for patients presenting with oligometastatic disease.~   "
169609|NCT01345526|"~     The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to~     evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to~     doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving~     first line cetuximab treatment.~   "
169610|NCT01345513|"~     This research is being done to find out what types of gene mutations are present in people~     with cancer. This study is designed to help researchers and doctors understand more about~     cancer. With this information, doctors may have a better idea as to which cancer treatments~     are most appropriate for certain patients. The information will also help researchers find~     out the how to identify genes in cancers from biopsies and blood samples and how to use this~     information to help doctors and patients make treatment decisions.~   "
169611|NCT01345500|"~     The purpose of the Take Charge Study is to determine among overweight and obese men and women~     with type 2 diabetes whether 1) participating in a commercial weight loss program promotes~     great weight loss and weight loss maintenance at one year compared to usual care conditions~     and 2) whether there is a differential weight loss response to different dietary~     macronutrient composition (lower carbohydrate/higher fat diet versus a higher~     carbohydrate/lower fat).~   "
169612|NCT01345487|"~     New Nordic diet guidelines advocate a reduction in consumption of protein from animal sources~     such as beef and pork, due to environmental concerns. Instead, intake of protein from~     vegetable sources such as legumes and pulses should be increased. However, little is known~     about the effect of protein from (Nordic grown) beans and peas on body weight and appetite~     regulation.~      The objective of this study is to examine if protein from vegetable sources (beans and peas)~     is comparable to protein from animal sources regarding acute meal-induced satiety.~   "
169613|NCT01345461|"~     As the critical care practice has improved over the last decades more patients are recovering~     from intensive care therapy. However, muscle atrophy and neuromuscular dysfunction are~     commonly observed sequelae after critical illness and are thought to play important roles in~     the development of intensive care unit acquired weakness (ICUAW). As a consequence, these~     entities may contribute to the impaired physical function and prolonged convalescence~     reported by ICU patients up to twelve months after discharge. Thus, strategies to counteract~     muscle atrophy and neuromuscular dysfunction acquired during the ICU stay may therefore~     potentially improve physical outcome and reduce the overall burden of critical illness.~     Limited information is available on muscle function in ICU patients and to our knowledge no~     muscle stimulation methods are currently available for evaluating muscle fatigue in large,~     proximal muscles groups, such as m. quadriceps, in non-cooperating ICU patients.~   "
169614|NCT01345448|"~     The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular~     pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied~     to the outside of one eyelid.~   "
169615|NCT01345435|"~     A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin~     A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2~     diabetes.~   "
169616|NCT01345422|"~     Patients with dizziness presently undergo physical therapy rehabilitation. Our study will~     study whether Wii Balance Board made by Nintendo Inc. will be helpful in patients with~     dizziness. They will undergo dizziness evaluation to quantify their dizziness.~   "
169617|NCT01345409|"~     Recent research examines many types of complementary and alternative (CAM) therapies.~     However, real-world use of CAM has been largely overlooked.~      This project consists of four discrete sets of project activities (that largely follow one~     another chronologically).~      Phase1 uses information from the EMR (patient electronic medical records) to identify unique~     clusters of patients with CMP (chronic musculoskeletal pain), their care within the health~     plan, and to examine how those in unique clusters may have different uses for A/C~     (acupuncture and chiropractic) services and/or differential outcomes associated with such~     care.~      Phase 2 will conduct a survey of CMP patients from KPNW (Kaiser Permanente Northwest region)~     to establish a broad sample of patients and their use of out-of-plan CAM services.~      Phase 3 will collect qualitative data (focus groups and individual interviews) from KP~     members, KP providers, and acupuncturists and chiropractors from the community to examine KP~     providers' decision to recommend A/C services, A/C services delivered to KP patients, and~     patients' decisions to pursue and retain CAM care. A secondary purpose is to have KP members~     with CMP review planned assessment instruments to improve understandability of the~     instruments. They will provide feedback on: relevancy, any notable omissions of domains~     important in patients' decision to use CAM services for pain treatment. They will also~     provide insight to broader health and quality of life outcomes associated with such CAM~     treatments.~      Phase 4 is a prospective cohort study to evaluate health services/costs and broader clinical~     and functional outcomes associated with the receipt of A/C relative to carefully matched~     comparison participants receiving traditional CMP services.~   "
169618|NCT01345396|"~     Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the~     level of asthma control can decrease during the pregnancy, especially between the 29th and~     the 36th week. The occurrence of such complications are linked with a high asthma severity~     level just before the conception and an history of respiratory complications in a previous~     pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be~     included in an educational progamme. However, this is poorly studied. The purpose of this~     study is to observe if an educational programme given before the 20th weeks of gestation has~     an effect on asthma control until the end of gestation.~   "
169619|NCT01345383|"~     The purpose of this study is to study the impact of smoking in the preceding hours before a~     bronchoscopy on the tolerance of this exam.~   "
169620|NCT01345370|"~     Treatment for newly diagnosed glioblastomas currently involves surgical resection followed by~     Temozolomide chemotherapy with concomitant radiotherapy, and then 6 cycles of Temozolomide in~     adjuvant. According to many studies, only those patients not expressing the enzyme repair~     MGMT benefit from the adjunction of Temozolomide. Therefore, many patients receive~     unnecessary treatment. The aim of this project is to compare different techniques for~     analysis of MGMT in order to choose the approach with the best cost/utility ratio, which will~     allow the selection of patients likely to respond to TMZ chemotherapy during the first course~     of GBM treatment.~   "
169621|NCT01345357|"~     The primary objective of the study is to determine the maximum tolerated dose (MTD) of~     CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors~     or mantle cell lymphoma.~   "
169622|NCT01345344|"~     This study design has two components: 1) a cross sectional assessment of brain connectivity~     and response to pain in healthy controls and demographically matched fibromyalgia patients,~     and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to~     either CBT (Cognitive Behavioral Therapy) or a Disease Education condition.~      The investigators will evaluate 90 fibromyalgia patients who will receive CBT treatment once~     a week for 8 weeks, for a total of 8 treatments. Baseline data from these patients will be~     compared to results from 30 pain-free controls and 60 education program controls.~      Participants will undergo experimental pain assessments as well as brain neuroimaging.~   "
169623|NCT01345331|"~     The Brigham and Women's Pain Management Center is conducting a research study for chronic~     pelvic pain patients due to endometriosis. The study will assess the effect of~     electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have~     chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking~     opioid medication (such as morphine or oxycodone). The study will require two visits, each~     lasting about 2 hours. The study takes place at the Brigham & Women's Pain Management Center,~     850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or~     ccahalan1@partners.org if interested.~   "
169624|NCT01345318|"~     This is a multi-center Phase 2, open label, safety extension study in subjects with moderate~     to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will~     have completed the 12-week induction period of study B0151003 and will be enrolled as either~     responders or non responders.~   "
169625|NCT01345305|"~     This is a study of 40 individuals with Sturge-Weber Syndrome (SWS) brain and/or eye~     involvement. It will examine the test-retest reliability of the following clinical tests:~        1. Quantitative EEG~        2. Transcranial Doppler~        3. Medical Rehabilitation Scales~        4. Optical Coherence Tomography~   "
169626|NCT01345292|"~     This study is for people with sensitive teeth and involves going to the dentist for 4 visits~     over 6 weeks.~      During the first 2 weeks, you will just brush your teeth two times a day with the fluoride~     toothpaste provided.~      Then you will be assigned to a group if you qualify to continue in the study. All groups will~     get a marketed toothpaste and one group will also get a mouthwash with an experimental~     ingredient. You will have an equal chance of being assigned to any one of the three groups.~      For the next 4 weeks, you will brush with your assigned toothpaste and rinse with your~     assigned mouthwash if assigned to the mouthwash group. A dentist will look at your mouth,~     teeth, tongue and gums and check for sensitive teeth. The investigators will see if the~     mouthwash helps to reduce tooth sensitivity during the study.~   "
169654|NCT01344928|"~     The objectives of this study are to investigate the effects of short-time high-intensity~     interval training on tissue glucose and fat metabolism in healthy lean subjects and type 2~     diabetic patients using modern and noninvasive imaging methods positron emission tomography~     (PET), magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).~   "
169792|NCT01343108|"~     Emotional labor is one of the bases that organizations earn profits. Nursing care needs high~     emotional labor to offer health care to patients. Among health carers that emphasize a lot on~     emotional labor, nurses are especially required to include emotional labor as very important~     parts of their jobs.~   "
169627|NCT01345279|"~     Indirect comparisons were performed using data from GOG-0179 versus GOG-0169 to permit~     comparison of topotecan in combination with cisplatin versus cisplatin plus paclitaxel via~     the common comparator of cisplatin monotherapy. Both GOG-0179 and GOG-0169 were conducted in~     patients with stage IVB, recurrent or persistent carcinoma of the cervix, but there were some~     differences between the respective study populations. Patients with prior chemotherapy were~     eligible for GOG-0179 but ineligible for GOG-0169 (except when chemotherapy was used for~     radiation sensitisation). Fewer patients had received chemotherapy as a radiosensitiser in~     GOG-0169 (27%) than in GOG-0179 (~60%) and these patients were unevenly distributed between~     treatment arms in GOG-0169. In addition, the proportion of patients receiving cisplatin as a~     radiosensitiser in GOG-0169 is unknown. For these reasons, there are limitations associated~     with the indirect meta-analysis.~   "
169628|NCT01345266|"~     This is a clinical study, with no investigational product, to characterise the inhalation~     profiles of healthy volunteers, volunteers with mild, moderate and severe Asthma and~     volunteers with mild, moderate and severe Chronic Obstructive Pulmonary Disease (COPD),~     through the novel dry powder inhaler.~   "
169629|NCT01345253|"~     The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to~     standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus~     erythematosus (SLE) over a 52 week period.~   "
169630|NCT01345240|"~     This study has been designed to support the indication of the candidate vaccine (also~     referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when~     administered as a primary vaccination integrated into an Expanded Program on Immunization~     (EPI) regimen to infants living in sub-Saharan Africa.~   "
169631|NCT01345227|"~     The goal of this study is to evaluate safety and feasibility of bone marrow (BM) as site for~     islet transplantation (Tx) in humans. The investigators hypothesis is that BM represents a~     better site than liver thanks to its potential capacity to favor islet engraftment in face of~     a more easiness of access and bioptic follow up.~   "
169632|NCT01345214|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-7746~     across multiple doses in patients with solid tumors and chemotherapy induced thrombocytopenia~     (CIT) scheduled to receive at least two cycles of myelosuppressive chemotherapy on Day 1~     every 21 days at the same dosages and schedule in the study. The secondary objectives are to~     characterize the PK profiles of ONO-7746 and to explore the pharmacodynamic effect of~     ONO-7746 on CIT.~   "
169633|NCT01345201|"~     This is an open-label Phase 1 dose escalation study of OMP-18R5 in subjects with a solid~     tumor for which there is no remaining standard curative therapy and no therapy with a~     demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers.~     Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and~     efficacy. No formal interim analyses will be performed.~      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon~     enrollment, subjects will receive intravenous (IV) infusions of OMP-18R5 at a assigned dosing~     schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there~     is no evidence of disease progression or if the tumor is smaller, then subjects may continue~     to receive IV infusions of OMP-18R5 every week until disease progression.~      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose~     escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled~     in a cohort will not be treated on the same day. The dose may be administered at any time~     during the day. Three subjects will be treated at each dose level if no dose-limiting~     toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be~     expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be~     dosed at that level and 3 additional subjects will be added to the preceding dose cohort~     unless 6 subjects have already been treated at that dose level. Subjects will be assessed for~     DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled~     subjects, if appropriate, will occur after all subjects in a cohort have completed their Day~     28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to~     continue to receive weekly doses of OMP-18R5 until disease progression. An additional 14~     subjects will be enrolled at the highest dose level that result in < 2 of the 6 subjects~     experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours)~     or 4 adverse event (DLT).~   "
169634|NCT01345188|"~     Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and~     shortness of breath despite conventional medical therapy and/or revascularization. The~     purpose of this study is to determine the efficacy of taking Ranexa versus placebo in~     patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional~     medical therapy and/or percutaneous revascularization.~   "
169635|NCT01345175|"~     The most common long-term problems after rectal surgery are bowel problems. These problems~     can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully~     clear your bowels, and/or poor control of gas and stool. The investigators believe that a~     major cause of these problems is too much bacteria in the bowel and treatment with antibiotic~     tablets will hopefully help improve these bowel problems. In order to test this idea, the~     Colorectal Surgery Service of Memorial Sloan Kettering Cancer Center is sponsoring a clinical~     trial. This trial will compare the antibiotic rifaximin and a placebo (a harmless tablet that~     has no effect) in the treatment of these bowel problems. Following this we will attempt to~     see if another antibiotic metronidazole also helps to treat these bowel problems. Both~     Metronidazole and rifaximin are well established drugs that have minimal side effects.~   "
169636|NCT01345162|"~     The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two~     different therapeutical protocols per os: ketorolac versus association of~     acetaminophene+tramadol.~   "
169637|NCT01345149|"~     Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight~     gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.~   "
169638|NCT01345136|"~     The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth~     of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients. Secondary objectives~     include determining if RAD001 treatment will improve hearing ability in NF2 patients.~      RAD001 is an oral drug that is approved by Food and Drug Administration (FDA) for other types~     of tumors, it is not approved by the FDA for treatment of NF2 related tumors.~   "
169639|NCT01345123|"~     The purpose of this study is to compare condition oriented whole person Health Coaching along~     with the provision of decision aids to decision aids without condition oriented Health~     Coaching to neither condition oriented health coaching nor decision aids on medical cost,~     preference sensitive surgeries and measures of subject knowledge, decision process and~     decision quality.~   "
169655|NCT01344915|"~     Knee immobilization in near extension has been proposed as a nonoperative treatment for~     primary traumatic patellar dislocation, although there exist no prospective studies regarding~     the method of immobilization. The objective of this prospective randomized study was to~     compare the clinical outcome after nonoperative treatment with restricted vs. free range of~     motion (ROM) for primary traumatic patellar dislocation.~   "
169640|NCT01345110|"~     Longitudinal observational study of cognitive functions, physical health and biological~     parameters in the whole population living in Abbiategrasso born between 1935 and 1939,1773~     subjects, followed for six years in order to know the prevalence and the incidence of~     dementia and risk and protective factors of normal and pathological mental aging.~      The peculiarities of this study that must assure the outcome efficacy are:~        -  Selected age: since 70-75 years old people represents a transition age from adulthood to~          old age, it is of special interest to study the evolution of psychic and physical~          functions of this population~        -  Whole population not a sample study~        -  Location: the small area involved (Abbiategrasso is a town of 30.000 inhabitants)can~          contribute to guarantee more homogeneity among the subjects and reduce undesired~          variability~        -  multidimensional assessment(biological, clinical, social, psychological data collected)~          After initial screening, the recruited population will be followed up for two more times~          (every two years )~   "
169641|NCT01345097|"~     The investigators determined whether~        1. new short, metaphyseal-fitting cementless anatomical femoral stem provides major~          functional improvements~        2. radiographically secure implant fixation is achieved with this new stem~        3. the bone content is preserved at the baseline level or above at the final follow-up~        4. these procedures are associated with early failure and complications.~   "
169642|NCT01345084|"~     Primary: to compare the overall survival defined as the time elapsed between the~     randomization date and death due to any cause, in both treatment groups.~      Secondary: to compare the progression-free survival, incidence of locoregional failure, site~     of the first recurrence/progression, objective response rate assessment, quality of life~     assessment and incidence of adverse events.~   "
169643|NCT01345071|"~     The first objective of the study is to evaluate a treat to target treatment strategy in women~     with moderate to high disease activity of RA and a pregnancy wish, from pre-pregnancy. The~     treatment strategy is based on deliberate treatment decisions to lower disease activity,~     including the continuation or start of biological treatment (in particular anti-Tumor~     Necrosis Factor [anti-TNF]), based on a standard care protocol in the Erasmus MC. The second~     objective is to evaluate the safety of the use of anti-TNF during pregnancy among women with~     a rheumatic disease that require the use of anti-TNF before or during pregnancy.~   "
169644|NCT01345058|"~     This is a study to determine whether a combination of low dose lacosamide and levetiracetam~     is more effective than high dose levetiracetam in patients who have failed low dose~     levetiracetam.~   "
169645|NCT01345045|"~     People with diabetes can, over time develop nerve damage throughout the body with symptoms~     such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.~   "
169646|NCT01345032|"~     The purpose of this study is to test two different interventions of nutrition follow up after~     discharge from geriatric ward in undernourished geriatric patients. The patients are~     randomized to a home visit arm, a telephone consultation arm, or a control arm. Patients in~     the home visit arm and their home care helper will get visits from a clinical dietician at~     one week, two weeks and four weeks after discharge, in order to follow up on the nutrition~     intervention. Patients in the telephone consultation arm and their home care helper will be~     contacted by a clinical dietician at one week, two weeks and four weeks after discharge, in~     order to follow up on the nutrition intervention. The control arm will not be contacted.~      The primarily outcome is functional ability. Secondary outcomes are quality of life,~     readmission and mortality.~   "
169647|NCT01345019|"~     The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in~     the treatment of bone disease from multiple myeloma.~   "
169648|NCT01345006|"~     This is a safety and tolerability trial to evaluate the effect of subretinal injection of~     human embryonic stem cell derived retinal pigment epithelium cells in patients with~     Stargardt's Macular Dystrophy (SMD).~   "
169649|NCT01344993|"~     This is a safety and tolerability trial to evaluate the effect of subretinal injection of~     human embryonic stem cell derived retinal pigment epithelium cells in patients with dry Age~     Related Macular Degeneration (AMD) and to perform exploratory evaluation of potential~     efficacy endpoints to be used in future studies retinal pigment epithelium (RPE) cellular~     therapy.~   "
169650|NCT01344980|"~     The investigators are comparing the combination of a stainless steel repair and aggressive~     early active range of motion rehabilitation protocol for flexor tendon lacerations in the~     hand with a current, accepted treatment offered at our institution. Outcomes to be assessed~     will be time to return to work, joint range of motion in the injured fingers, and any~     potential complications that may arise (ex: surgical infections or repair rupture). All~     proposed treatments included in this study are currently being offered at our institution,~     but not in a randomized fashion.~   "
169651|NCT01344967|"~     Bone is the most common site of spread of breast cancer and bone metastases will occur in~     roughly 70% of women with advanced disease. These patients are at risk of developing bone~     complications that cause significant impact on both patient morbidity and mortality. Close to~     two-thirds of women with bone metastases will go on to develop at least one of these~     complications, termed a skeletal related event (SRE), defined as 1) pathological fractures,~     2) pain requiring radiation or surgical intervention, 3)spinal cord compression, and 4)~     hypercalcemia. In addition to SREs, most breast cancer patients with bone metastases have~     some degree of pain associated with their disease. Understandably these factors negatively~     impact their quality of life. Furthermore, the development of an SRE in this population has~     been shown to be associated with shorter overall survival. Prevention or delay in onset of~     these complications is therefore an important therapeutic goal.~   "
169652|NCT01344954|"~     The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402~     administered as a single intravenous infusion for the prevention of VTE in subjects~     undergoing total hip replacement surgery.~   "
169653|NCT01344941|"~     The primary objectives of this study is to~        -  Define the envelope-specific B-cell and T-cell responses in humans who have received a~          St. Jude HIV-1 vaccine.~        -  Describe mechanisms of HIV-1 envelope processing and consequent B-cell and T-cell~          activities.~   "
169656|NCT01344902|"~     The purpose of the study is to determine if it is possible to detect more pre-cancerous~     lesions in colon when using fluorescence technology.~   "
169657|NCT01344889|"~     This observational study will assess factors leading to dose reductions/treatment~     discontinuations and the effect on sustained virological response in patients with chronic~     hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and~     ribavirin. Data will be collected from each patient for the duration of their treatment and~     for up to 6 months thereafter.~   "
169658|NCT01344876|"~     To determine the maximum tolerated dose (MTD) of OPB-51602~   "
169659|NCT01344863|"~     This randomized, open-label, parallel, 2-arm, multicenter study will compare the~     administration of Herceptin (trastuzumab) with a single-use injection device versus a~     handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600~     mg Herceptin. The anticipated time of the study is 21 weeks.~   "
169660|NCT01344837|"~     This research study is studying biomarkers in blood and tissue samples from patients with~     uterine cancer. Studying samples of blood and tissue from patients with cancer in the~     laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers~     related to cancer.~   "
169661|NCT01344824|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving~     carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium~     together with bevacizumab works in treating patients with stage III or stage IV non-small~     cell lung cancer who are light or never smokers.~   "
169662|NCT01344811|"~     A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart~     Care Service in obese patients with metabolic syndrome.~   "
169663|NCT01344798|"~     The purpose of this trial is to study the evaluation of clinical safety and feasibility of~     gene therapy in patients with limb girdle muscular dystrophy type 2C~     (gamma-sarcoglycanopathy).~   "
169664|NCT01344785|"~     The purpose of this study is determine the relationship between pain and protrusion of the~     implant after surgery for a intertrochanteric fracture.~   "
169665|NCT01344772|"~     The primary aim of this study was to determine the Harris hip score as an evaluation of hip~     function, in mentally competent elderly patients (>65 years old) treated with either THR or~     IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the~     rate of reoperations and complications between the two groups.~   "
169666|NCT01344759|"~     The purpose of this research study is to examine the effects of two commonly used anesthetic~     drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in~     children, adolescents, and young adults with a history of obstructive sleep apnea (OSA)~     having an MRI scan.~      The results of this study will help in making the best decisions regarding the anesthesia~     medications that are most appropriate for children, adolescents, and young adults with OSA~     during MRI studies.~   "
169667|NCT01344746|"~     Our goals are to demonstrate an active leukotrienes (LTs) mediated inflammatory response is~     involved in pathophysiology of sleep-disordered breathing (SDB), and to provide a theoretical~     evidence for LTs modify therapy in treating pediatric patients with SDB.~      The investigators have hypothesized that the pathophysiology of pediatric SDB involves~     specific systemic and local upper airway inflammatory response mediated by LTs.~        1. LT concentration assays reveal higher levels in serum for both leukotriene B4 (LTB4) and~          cysteinyl leukotrienes (CysLTs) and in morning urine for LTE4 of SDB children, in~          comparison to healthy ones, and LTs productions emerge disease severity-dependent~          increases.~           There is a positive correlation between LTs production and other systemic markers such~          as neutrophil counts and high sensitive C-reactive protein (hsCRP).~        2. Children with SDB have higher leukotriene receptor-1 (LT1-R) and leukotriene receptor-2~          (LT2-R) expressions in adenotonsillar tissues of SDB children compared to recurrent~          infectious tonsillitis subjects.~        3. Levels of LTs are positively correlated with body mass index (BMI) z-score, waist height~          ratio (WHtR), adenotonsillar size and polysomnography (PSG) indices including~          apnea-hypopnea index (AHI), obstructive apnea index (OAI), oxygen desaturation index~          (ODI), arousal index, percentage of time spend saturation lower than 90% (SLT90%) and~          negatively correlated with mean and minimal pulse oximetric saturation (SpO2), which~          indicates synergistic role of obesity and hypoxia are the determinants of LTs production~          in SDB.~        4. In adenotonsillar mixed cell culture system, the addition of LTs can increase cellular~          proliferation rates and exhibit dose-dependent responses, whereas leukotriene receptor~          antagonists (LTRAs) elicit dose-dependent cellular reductions.~   "
169668|NCT01344733|"~     The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of~     HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the~     study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients~     matching inclusion and exclusion criteria will be enrolled consecutively; each investigator~     will include the first 10 to 40 patients that will be visited as treatment resistant MDD.~   "
169669|NCT01344720|"~     This randomized, single-blind, parallel-group study will investigate the efficacy and the~     tolerability of a combination treatment of etoricoxib (30 mg/day) plus controlled-release~     oxycodone (10 mg/day) compared with a titrated dose of etoricoxib up to 60mg/day as~     monotherapy , in patients with Chronic Low Back Pain (CLBP) who have not responded to the~     starting dose of Etoricoxib 30mg/day. A common clinical question is that is it better to~     increase the dose of the current monotherapy or to combine both treatments early on, in~     patients who do not respond to standard start doses of NSAIDs like etoricoxib.~   "
169670|NCT01344707|"~     The purpose of this study is to determine the Maximum Tolerated Dose, Dose Limiting~     Toxicities and optimal dosing schedule of 4SC-202 investigating its safety, tolerability and~     pharmacokinetics.~   "
169671|NCT01344694|"~     Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty~     liver, a condition carrying a high risk of cardiovascular disease. The independent role of~     epicardial fat deposition in cardiovascular risk remains unclear.~   "
169672|NCT01344681|"~     This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic~     refractory fever. The investigators evaluate efficacy and safety of micafungin sodium~     (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a~     control and this study is prospective, randomized, non-inferiority trials.~      Therefore, this study was planned for review of the safety and efficacy in korean patients.~   "
169677|NCT01344616|"~     Timely screening and management of modifiable conditions can reduce preterm births, yet~     providing effective prenatal risk management systems to meet the unique needs of medically~     underserved populations is complex. If the proposed system proves to be effective in reducing~     preterm births it can improve maternal and child quality of life as well as reduce the~     economic burden of preterm births in the U.S.~   "
169678|NCT01344603|"~     In the present study the investigators test the hypothesis that the epidural anesthesia added~     on the general anesthesia is able to improve patient's outcome.~   "
169679|NCT01344590|"~     Vascular access via central venous lines (CVL) is essential to the care of many patients in~     the intensive care setting. While the value of these lines for the management of critically~     ill patients is generally accepted, the potential for line-associated blood stream infection~     is a known complication of the use of this intervention.~      Ethanol is an effective antimicrobial agent with activity against a broad spectrum of human~     pathogens.~      The purpose of this study is to evaluate the effectiveness of daily treatment of the catheter~     lumen with ethanol to prevent central line associated blood stream infections (CLABSI). The~     hypothesis is that this treatment will reduce the incidence of CLABSI compared to maintenance~     of the lines with normal saline alone.~   "
169680|NCT01344577|"~     The purposes of this study are : (first) to evaluate comparatively the effectiveness of 2~     HA-based biomaterials when used for socket preservation with Buccal Plate Augmentation~     technique; (second) to evaluate clinical outcomes of socket preservation procedures performed~     using the Buccal Plate Augmentation technique.~   "
169681|NCT01344564|"~     The purpose of this study is to determine if patients initiating androgen deprivation therapy~     (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate~     after an initial three-month period without a rise in serum testosterone. The investigators~     expect testosterone will quickly and reliably reach castrate levels after initiation of ADT~     and will remain castrate during the transition, and there will be no testosterone surge~     after leuprolide injection.~   "
169682|NCT01344551|"~     To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function~     in healthy older adults.~   "
169683|NCT01344538|"~     The purpose of this study is to determine if ginger root extract when taken daily for 28 days~     is able to decrease levels of inflammatory chemicals called eicosanoids in the gut tissue of~     people who are at normal risk and those at increased of developing colorectal cancer compared~     to people taking placebo.~   "
169684|NCT01344525|"~     Obese individuals that undergo major intervention such as a low-calorie formula diet program~     or bariatric surgery with the result of substantial weight loss (> 10%) are included and~     followed-up for at least 3 years. Weight changes and excess weight loss as well as measures~     of quality of life are monitored. In addition, biomaterials will be collected from these~     individuals every 6 months for measurement of parameters related to obesity-associated~     gastrointestinal (GI) impairments such as change in GI hormone levels, change in GI~     microbiota, or enhanced bacterial translocation. Moreover, micronutrient and metabolomics~     analysis will be performed. This project allows comparison of non-surgical and surgical~     intervention and enables to asses the anticipated relationship between obesity and the GI~     tract in humans in the future.~   "
169685|NCT01344512|"~     The Pharm A project is a French national collaborative project aiming to determine the~     population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric~     patients aged one month to five years.~   "
169686|NCT01344499|"~     Measurement of residual peritoneal fluid after laparoscopic surgery~   "
169687|NCT01344486|"~     Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease~     post-operative pain, inflammation and adhesion formation.~      Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain~     and adhesion formation.~   "
169688|NCT01344473|"~     Fixed dental braces are associated with the risk of developing White Spot Lesions (WSLs),~     which appear as white chalky marks on the teeth. They develop as a result of the acid~     produced by bacteria in dental plaque dissolving the outer surface of the tooth, known as~     demineralisation. Recently, amorphous calcium phosphate (ACP) stabilised by casein~     phosphopeptide (CPP) has become available, and it is reported to help rebuild the surface of~     teeth which have WSLs. CPP-ACP is available incorporated into a crème known as Tooth Mousse~     (TM). While there appears to be sufficient evidence regarding the use of CPP-ACP in promoting~     general remineralisation, for the first time this study aims to examine the use of CPP-ACP to~     treat WSLs in post-orthodontic participants.~   "
169689|NCT01344460|"~     Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic~     resonance angiography) will be invited to participate in the study and subjects will be~     involved in the study for between 2 and 12 days. Two to three visits to the study doctor will~     be required.~      This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA~     images taken without contrast agent using images from a CTA as the standard of reference,~     which may have been performed up to 60 days prior to enrolment. If a CTA has not been~     performed in this prior time period, a CTA is required for the study.~      MRA and CTA images will be collected for an independent review (blinded read).~   "
169690|NCT01344447|"~     Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic~     resonance angiography) will be invited to participate in the study and subjects will be~     involved in the study for between 2 and 12 days. Two to three visits to the study doctor will~     be required.~      This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA~     images taken without contrast agent using images from a CTA as the standard of reference,~     which may have been performed up to 60 days prior to enrolment. If a CTA has not been~     performed in this prior time period, a CTA is required for the study.~      MRA and CTA images will be collected for an independent review (blinded read).~   "
169691|NCT01344434|"~     This study hypothesizes that renal transplantation candidates are diagnosed with significant~     Coronary Artery Disease (CAD) equal with non-invasive modalities as with invasive modalities.~     Therefore the investigators are investigating the ability of coronary computed tomographic~     angiography (cCTA), myocardial perfusion scintigraphy (MPS), acoustic CAD Patch and~     combination hereof to detect CAD as defined by invasive Coronary angiography (CAG).~   "
169693|NCT01344408|"~     BACKGROUND A Cochrane review from 2003 found that about 30% of people 65 years or older each~     year fall and that number is even higher for elder people living in institutions. Falls are~     the cause of 95% of all hip fractures, resulting in prolonged hospitalization and prolonged~     disability. In patients who are referred to the emergency room after unexplained fall, a~     study of 564 patients showed that 80% of the patients had vestibular symptoms characterized~     by balance problems, nausea, impairment, vomiting, and dizziness. 41% of the patients had~     dizziness suggesting a dysfunctional vestibular system called vestibular dysfunction. In~     patients with vestibular dysfunction, vestibular rehabilitation (VR) can reduce fall risk.~     Several studies show however that the elderly has a decreased compliance in relation to the~     performance of home exercise.~      A solution to support the older vestibular rehabilitation process and to maintain the~     achieved level of functionality after the rehabilitation process is the computer-training~     program Move It To Improve It (MITII). Based on individual studies and tests therapists~     develop a personalized rehabilitation program permanently corrected, modified and adjusted.~     The system generates feedback to the therapists at hospital with information about the~     person's daily training and scores of individual exercises. The Web cam makes it possible to~     make video footage and pictures to be used in the feedback information. The system also~     establish direct communication between users and therapists. The web community provide the~     framework for a telerehabilitation system, which means that the hospital can service more~     users in the same period.~      The ph.d. consist of three studies which has the purposes:~      To compare a computer exercise program (Mitii) with conservative home-training according to~     printed instructions in the rehabilitation of patients with vistibular dysfunction in an~     outpatient clinic To investigate whether the effect of vestibular rehabilitation is preserved~     three months after the completion of supervised training in an outpatient clinic for specific~     vestibular rehabilitation and whether a computer assisted home training program (Mitii) is~     superior to printed instructions in this respect To evaluate patient experience and barriers~     for the use fo the computer assisted rehabilitation of patients with vestibular dysfunction~   "
169694|NCT01344395|"~     The primary aim of this study is to evaluate if multiple postoperative administrations with a~     solution of ropivacaine, ketorolac and epinephrine into the operating field through a~     catheter would affect morphine consumption. Secondary end-points are pain intensity, side~     effects and length of stay.~   "
169695|NCT01344382|"~     This project will modify Community Reinforcement and Family Training (CRAFT; n=15) and~     Alanon/Naranon Facilitation (ANF; n=15) for use with parents who are concerned about an~     out-of-treatment adolescent. ANF was selected as a comparison because Alanon and Naranon are~     the most commonly available method for helping family members. The investigators will compare~     CRAFT for parents (CRAFT-P) (n=77) and ANF (n=77) to determine if there is a significant~     difference in adolescent treatment entry. Parents will attend a maximum of 18 sessions with a~     family specialist and also complete questionnaires periodically over a 12-month period.~     Parents' adolescents will have the opportunity to participate in the study by completing~     questionnaires at the same time points as their parent. Our primary hypothesis asks whether~     participants who are enrolled in the CRAFT-P condition will report more adolescent treatment~     entry than the ANF condition. Our secondary hypotheses examine: 1) reductions in adolescent~     substance use and behavior problems in the CRAFT-P group compared to the ANF condition, 2)~     improvements in parenting skills in the CRAFT-P group compared to the ANF condition and 3)~     significant pre to post treatment effects for improvements in social functioning, mood, and~     in parent-adolescent relationship satisfaction.~   "
169696|NCT01344369|"~     The purpose of this study was to evaluate the relative bioavailability of a test formulation~     of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals,~     USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol~     and ferrous fumarate) 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) under fed conditions~     in healthy, non-tobacco using, adult female subjects.~   "
169697|NCT01344356|"~     This study will evaluate the local control rates as well as acute and late toxicity rates of~     stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck~     tumors.~   "
169698|NCT01344343|"~     There is preliminary evidence that suggests early surgical treatment of a hip fracture may~     improve patients' outcomes. The investigators propose to do a pilot randomized controlled~     trial (RCT) to assess the feasibility of a large RCT comparing accelerated surgical repair~     (i.e. surgery within 6 hours of a hip fracture diagnosis) versus standard care (typically~     surgery after 36-48 hours).~   "
169699|NCT01344330|"~     This research study will assess cruciferous vegetable intake in patients presenting for~     screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC)~     expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The~     investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of~     cruciferous vegetable intake.~   "
169700|NCT01344317|"~     Introduction: Methylxanthines and doxapram have been widely used for the treatment of apneas~     of prematurity. Both substances have effects on the central nervous system. While there are~     data available concerning the use of caffeine (the methylxanthine used at our NICU) even~     proposing a positive effect on neurodevelopmental outcome of very preterm infants, there are~     data which suggest a negative effect of the central stimulants doxapram on longterm outcome~     in this group of infants. Nevertheless concerning both medications only few studies have been~     published and only scarce data are available concerning the effect of these medications on~     brain activity of very preterm infants until now.~      The aim of this study: is the assessment of the effect of stimulating substances on brain~     activity of preterm infants born below 30 weeks of gestation and their longterm~     neurodevelopmental follow-up.~      Methods: This study is a prospective study including preterm infants born below 30 weeks of~     gestational age. Brain activity is measured by one-channel amplitude-integrated EEG (aEEG).~     The first aEEG measurement is performed without caffeine and/or doxapram medication. At least~     one hour of brain activity is registrated. The second measurement is done at least 24 hours~     after the start of caffeine and/ or doxapram treatment.~      The percentage of different background patterns, the occurrence and duration of~     sleep-wake-cycling, and the occurrence and duration of seizures is assessed and analysed.~     Neurodevelopmental outcome is assessed at one and two years of corrected age by assessment of~     the Bayley Scales of Infant Development II and standardized clinical neurological~     examination.~   "
169701|NCT01344304|"~     The object of this study is to evaluate the superiority of aprepitant therapy with a~     5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a~     5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first~     course chemotherapy.~   "
169702|NCT01344291|"~     Prolactinoma is the most prevalent anterior hypophysis tumor. The principal treatment for~     this disorder is Dopamine agonist drugs including bromocriptin and Cabergoline. However, 50%~     of Bromocriptin treated and 17% of Cabergoline treated patients are resistant to these drugs.~     Curcumin is the main derivative of turmeric ,an old spice which is used frequently in Indian~     and Iranian cuisine. It has been proved that curcumin can reduce mammotrope cells~     proliferation and also intracellular hormone production. The purpose of this study is to~     evaluate the effect of turmeric on prolactinoma patients.~   "
169703|NCT01344278|"~     The main goal of this study is to examine the comparative effectiveness of diabetes~     prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the~     following conditions: obesity, hyperglycemia, hypertension and depression. This randomized~     lifestyle intervention study will be conducted at Kaiser Permanente Northern California.~     Women in the intervention will receive a letter on gestational weight gain during pregnancy~     and in the postpartum period, a curriculum of individualized lifestyle counseling via~     telephone, augmented with e-mail and an interactive Web site. Patients randomized to the~     usual care arm will receive the standard-care telephone calls from the Perinatal Center~     during pregnancy and the Center's printed educational materials postpartum. Outcomes will be~     assessed through the electronic medical record and patient surveys conducted during pregnancy~     and at 6-weeks, 6- months and 1-year postpartum.~   "
169704|NCT01344265|"~     The investigators hypothesized that the serum B-type Natriuretic Peptide (BNP) level may be~     correlated with global end diastolic volume (GEDV) as measured by transpulmonary~     thermodilution technique (PiCCO). The rationale is that some animal studies have proven that~     BNP is released from ventricular myocardium in response to physical expansion. Such physical~     expansion can be measured by GEDV. If the hypothesis can be confirmed with our study, the~     serum level BNP can be used to monitor volume status of critically ill patient, instead of~     the invasive monitoring system.~   "
169705|NCT01344252|"~     The options for anesthesia in cataract surgery described are: general, regional or local. The~     local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar),~     subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar,~     have made subtenon and topical strategies the most used. Likewise, to improve the~     effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose~     of lidocaine.~      Subtenon and topical anesthesia are two safe strategies and there were performed multiple~     studies showing that both are effective in controlling pain, but showing a slight superiority~     of subtenon. This difference does not appear to be clinically significant. In turn, the~     addition of gel and intracameral anesthesia, improved pain control. However, lack evidence to~     compare patient preference when using topical gel and intracameral anesthesia versus~     sub-Tenon anesthesia.~      Multiple advantages has the topical anesthesia. Besides being a safe strategy for the~     patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia~     postoperatively, subconjunctival hemorrhage and chemosis.~      Because of this the investigators plan to conduct a study comparing the efficacy of gel~     topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with~     scleral incision, assessing the patient's preference Hypothesis: Topical administration of~     lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia in~     cataract surgery~   "
169706|NCT01344239|"~     To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects~     against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal~     aortic aneurysm (AAA) repair.~   "
169707|NCT01344226|"~     Investigate the intraocular pressure(pressure inside the eye) of patients who are treated~     with Lotemax after undergoing cataract surgery.~   "
169708|NCT01344213|"~     To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of~     intrathecal morphine for patients after total knee arthroplasty.~   "
169709|NCT01344200|"~     Background: Celecoxib is effective for reducing postoperative pain in adults. Children use~     celecoxib more rapidly than adults and require higher doses. Celecoxib is partially~     metabolized in the liver by a certain enzyme. A person's genetic variation of this enzyme can~     influence how well their body uses Celecoxib. Understanding the blood and cerebrospinal fluid~     (CSF) profile of celecoxib in children and the influence of genetics on metabolism would help~     to develop appropriate celecoxib dosing in children for various treatment options.~      Objective(s) and Hypothesis: Our primary objective will be to create a pediatric profile of~     celecoxib in the blood and the central nervous system as well as explore the relationship~     between CYP2C9 polymorphisms and documented adverse events~      The investigators hypothesize that the CSF concentrations of Celecoxib post dose are lower~     than plasma levels, take longer to reach peak concentration and are directly related to dose,~     genetics, and age. The investigators expect that Celecoxib will improve quality of life and~     reduce discomfort when administered before and after a lumbar puncture and bone marrow~     aspirate.~      Potential Impact: The results of this study will establish the safety of celecoxib in~     children as well as help us define the best dosing for acute pain. It may also help reduce~     the incidence of acute pain evolving into chronic pain. Finally, it may provide insight into~     celecoxib's future use in chemotherapy.~   "
169710|NCT01344187|"~     The objectives of this study are to evaluate the safety and efficacy of corneal collagen~     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as~     compared to placebo in impeding the progression of, and/or reducing, maximum corneal~     curvature.~   "
169711|NCT01344174|"~     This is a randomized, open label study evaluating the efficacy and safety of glucocorticoids~     in patients with HBV associated pre-ACLF.~      Sponsor: Department of infectious diseases, Southwest Hospital.~      Indication: HBV associated acute-on-chronic pre-liver failure(pre-ACLF-HBV).~      Objective: To evaluate the efficacy and safety of glucocorticoids in patients with~     pre-ACLF-HBV.~      Trial Design: Randomized, open label study. Patients with pre-ACLF-HBV will be randomized 1:1~     to One of the two groups:~      A)Dexamethasone 10mg were intravenously injected po daily for the first 5 days, in~     combination with continued lamivudine 100mg po daily and traditional supporting treatments~     for 13 weeks. B)Control group. Any glucocorticoids will be not given in all patients.~     Continued lamivudine 100mg po daily and traditional supporting treatments will be given for~     13 weeks.~      Number of patients: Approximate number of patients to be randomized: N=200 (100 patients in~     each group).~      Length of study: Screening period: 3 days; treatment period: 13 weeks.~      Duration of study: 30 months after first patient randomized, including an recruitment period~     of 26 months.~      Investigational treated regimen:Dexamethasone 10mg, iv, once day for 5 days.~      Concomitant and Comparative regimen: Lamivudine 100mg po daily, traditional supporting~     treatments.~      Assessments of Efficacy Primary endpoint: the survival rate at week 13. Secondary~     endpoint:①The levels of serum T-Bil ≤ 51.3µmol/L;②PTA ＞80%.~      Safety: Adverse events, vital signs, and laboratory tests.~      Procedures(summary): After signing informed consent and meeting screening parameters,~     patients will be randomized to one of the two treatment groups as described under trial~     design above. After randomization patients will be seen for evaluation at days~     5,10,14,21,28,42,56,70,84,91.~      Statistical analysis: Assume 1:1 randomization. The sample size is calculated for the primary~     efficacy variable, the survival rate. Assuming the survival rate equals to: 90% for group A~     and 50% for group B. 100 patients in each group are required to yield a 80% chance of~     detecting such a difference when a two-tailed test is employed at the 0.05 significance~     levels. Every eligible subject will be assigned with a randomization code and receive one of~     the two treatments, according to the sequence of enrolled.~   "
169712|NCT01344161|"~     The investigators investigated the effect of vitamin D3 supplementation on metabolic profile~     (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in~     overweight or obese women.~   "
169713|NCT01344148|"~     To determine the best time to begin anti-HIV(Acquired Immunodeficiency Syndrome) treatment in~     individuals who co-infected with HIV and tuberculosis (Tb). This prospective, randomized~     study is being conducted on HIV/Tb co-infected patients in China to evaluate and compare the~     efficacy of antiretroviral therapy after 2 weeks TB treatment versus deferred ART initiated 8~     weeks after initiation of TB treatment.~   "
169714|NCT01344135|"~     To study in clinically stable Chronic Obstructive Pulmonary Disease (COPD) patients with~     muscle atrophy:~        1. The short-term effects of 4 months exercise training including nutritional~          supplementation versus exercise training alone on physical functioning (skeletal muscle~          strength and exercise capacity) and body composition.~        2. The long-term effects of 4 months of exercise training and nutritional supplementation~          followed by 8 months of nutritional counseling (with supplementation on advice) and~          feedback on physical activity level versus 4 months of exercise training and 8 months~          with feedback on physical activity level alone on physical functioning, body composition~          and cardiometabolic risk profile;~        3. The cost-effectiveness of exercise rehabilitation and nutritional intervention versus~          exercise rehabilitation alone.~   "
169715|NCT01344122|"~     The goal of this study is to see whether or not a strategic planning process is able to~     introduce and sustain improvements in the working relationship between probation/parole~     departments and community-based addiction treatment agencies that provide medication assisted~     therapy (MAT) for individuals with opioid or alcohol dependence. In addition, this study~     seeks to improve probation/parole agency personnel's knowledge and perceptions about MAT, and~     increase the number of appropriate referrals to community treatment agencies that provide~     MAT. There are three phases to this study. Phase 1 includes a pilot study to determine the~     quality and availability of client level records and the collection of baseline data (the~     pilot study protocol was previously submitted to TMH IRB). Phase 2 will consist of a~     Knowledge, Perceptions and Information (KPI) intervention during which probation/parole~     agencies will undergo training to increase knowledge about the effectiveness of MAT, and~     complete a post training assessment to evaluate the effectiveness of the KPI intervention.~     During Phase 3, probation/parole agencies will be randomly assigned to a 12-month~     Organizational Linkage Intervention (OLI) condition or to control (no further intervention).~     Agencies assigned to the OLI will establish a Pharmacotherapy Exchange Council (PEC) that~     consists of staff from both the probation/parole and community treatment agencies. The PEC~     will undergo a strategic planning process to increase the availability of MAT for opiate~     and/or alcohol dependent individuals who are on probation/parole.~   "
169716|NCT01344109|"~     This is a pilot study evaluating the use of tumor derived exosomes as a marker for response~     to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer.~     Tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in~     breast cancer, which could prove to be a tool for earlier diagnosis, more effective~     treatments, and improved markers of response in order to increase survival rates.~   "
169717|NCT01344096|"~     In Gaucher disease type I bleeding is a common presenting symptom, that may manifest itself~     as frequent nose bleeds, easy bruising but can also cause substantial bleeding after surgical~     or dental procedures and may occur in association with pregnancy or delivery . The bleeding~     tendency is usually considered to be secondary to thrombocytopenia However 50,000 platelets~     are enough in healthy people to give a normal bleeding time but are associated with~     significant bleeding tendencies in Gaucher patients. Bleeding tendency might be attributed by~     genetic inherited or Gaucher related coagulation factors abnormalities which in some cases~     stabilize with ERT. However, In other cases the etiology is an abnormality of platelet~     function. This thrombocytopathy has not been delineated and apart from a few aggregation~     studies, no systematic analysis has been published that convincingly shows the cause of the~     disturbed function. While, experience shows that enzyme replacement (ERT, i.e: imiglucerase,~     Cerezyme®) reduces this bleeding tendency, in part due to the improvement in the thrombocyte~     count and elevation in coagulation factors, it is less clear what effect ERT has on the~     thrombocytopathy. This has clinical significance when patients need to be prepared for~     surgery or delivery or in the event of a major bleed. There is no consensus as to how~     patients should be prepared or treated. Different centres use different approaches. When the~     procedure is elective ERT is appropriate but in other situations DDAVP, fresh frozen plasma~     and platelet infusion are possible treatments. Even activated factor VII has been used when~     bleeding was not controlled. As in any other coagulation abnormality, treatment should be~     tailored to the specific cause of the bleeding diathesis. The aim of this study is to define~     the etiology of platelet dysfunction in Gaucher patients.~      Hypothesis: The investigators expect to see a difference between platelets activation profile~     among imiglucerase treated and untreated patients with at least a partial restoration of~     platelets function due to treatment commencement.~   "
169718|NCT01344083|"~     The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine~     eye drops in the topical treatment of seasonal allergic conjunctivitis.~   "
169719|NCT01344070|"~     Generic formulations of prescription drugs can, through their relatively lower cost, improve~     healthcare as long as they maintain their registration-quality and public trust. On the other~     hand, the market availability of several generic formulations raises a concern regarding~     their interchangeability, despite being proven to be individually therapeutically~     interchangeable with their corresponding innovator formulation.~      The investigators propose to assess the quality and therapeutic interchangeability of generic~     formulations in the drug market of Saudi Arabia, using fifteen, commonly-used, oral, solid,~     immediate-release, and non-combinational drugs.~   "
169720|NCT01344057|"~     This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza~     Vaccine Administered to Elderly Subjects.~   "
169721|NCT01344044|"~     This study aims to examine the efficacy of a brain-computer interface system for the~     treatment of inattentive symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The~     investigators hypothesis is that children with ADHD receiving treatment with the BCI-based~     training will improve to a greater extent than the control group.~      Additionally, the investigators are also conducting an fMRI study involving interested~     participants, to elucidate the neural mechanisms underlying any behavioural improvement. This~     is necessary to help the investigators gain a better picture of brain correlates related to~     ADHD and understand how the intervention can affect the brain.~   "
169722|NCT01344031|"~     This phase I trial studies the side effects and the best dose of MK 2206 (Akt inhibitor~     MK2206) when given with anastrozole, fulvestrant, or anastrozole and fulvestrant in treating~     postmenopausal women with breast cancer that has spread to other parts of the body. Estrogen~     can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant~     may fight breast cancer by lowering the amount of estrogen the body makes. Akt inhibitor~     MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving Akt inhibitor MK2206 together with anastrozole, fulvestrant, or anastrozole~     and fulvestrant may kill more tumor cells.~   "
169723|NCT01344018|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that~     needs to be removed. It is not yet known whether surgery is more effective with or without~     radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.~      PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to~     see how well it works compared with surgery alone in treating patients with previously~     untreated nonmetastatic retroperitoneal soft tissue sarcoma.~   "
169724|NCT01344005|"~     RATIONALE: Diagnostic procedures, such as an urgent chest x-ray, may help in planning cancer~     treatment. It is not yet known whether standard medical care is more effective than an urgent~     x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.~      PURPOSE: This randomized clinical trial is studying standard medical care to see how well it~     works compared with an urgent chest x-ray in diagnosing lung cancer in smokers with chest~     symptoms who are older than 60 years.~   "
169725|NCT01343992|"~     A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF~     (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment~     with donated oocytes. All the procedures of IVF, of the embryo transfer, and of the~     administration of medications are performed as always and there are no variations. The only~     highlighted procedure in this study is immediately after the embryo transfer. There are two~     groups: one which will rest in bed for 10 minutes after the transfer and one which will not~     rest after the transfer. Both procedures are common, usually depending on the habitual~     clinical practice of each clinic internationally. Patients from both group receive the~     routine post transfer instructions and treatment.~   "
169726|NCT01343979|"~     This retrospective study will analyse all PCR-proven H1N1 cases from the influenza season~     2009/2010 treated within the styrian LKH hospital network. For this purpose all~     PCR-positive case files are reviewed in Medocs (electronic patients database) and data~     regarding clinical presentation, laboratory and radiological findings, treatment, outcome and~     preexisting underlying chronic illnesses will be systematically collected. In a second step~     the same data collection will be performed in a group of PCR-negative patients, which were~     tested during the influenza season 2009/2010 for influenza-like illness. The data from the~     PCR-positive group will be compared to the data from the PCR-negative group. We expect~     significant differences between the proven and unproven group regarding the primary~     presentation at hospital. Based on these results a clinical score will be developed. This~     score should improve H1N1 case identification in emergency departments, even if specific~     diagnostic test are negative (rapid antigen testing) or still pending (PCR), reduce the~     number of missed hospitalized H1N1 infection and optimize the decision making process in~     emergency departments regarding which patient has to be admitted with infection control~     measures and which not, and as infection control measures are expensive (face masks, gloves)~     and limited (isolation room), such a score should also reduce unnecessary expense. To~     evaluate the sensitivity and specificity of the score a prospective study will follow in the~     influenza season 2010/2011.~   "
169727|NCT01343966|"~     This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to~     evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's~     Disease.~   "
169728|NCT01343953|"~     This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or~     Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in~     the absence of an HLA identical donor;~   "
169729|NCT01343940|"~     Project Dulce is designed to test a new approach to delivering family support, in the context~     of the primary care medical home. The target population to be served is infants between birth~     and 6 months old and their families who receive primary care at Boston Medical Center. A~     dulce family partner will reach infants and families through their routine health care visits~     during their first six months of life and provide them with support for unmet legal needs,~     screen infants for developmental problems, screen families for mental health problems, and~     improve families' knowledge of child development. The control group will receive training on~     safe sleep and safe transportation for their newborn.~   "
169730|NCT01343927|"~     A randomized controlled trial for chronic low back pain in predominantly minority populations~     with three treatment arms: yoga, physical therapy, and education. Four cohorts of~     participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary~     outcomes are pain intensity and measure of disability; secondary outcomes are pain medication~     use, treatment adherence, and health-related quality of life.~   "
169731|NCT01343914|"~     This retrospective observational study will analyse demographic, clinical and~     treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who~     had reached >/= 9 months of progression-free survival after Avastin (bevacizumab)-based~     first-line therapy. Data will be collected for approximately 9 months.~   "
169732|NCT01343901|"~     This observational study will evaluate the efficacy and safety of bevacizumab as first-line~     treatment in participants with colorectal cancer and potentially resectable liver metastases.~   "
169733|NCT01343888|"~     The objective of this trial is to evaluate the efficacy and safety of two different treatment~     regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care~     (SOC) with PegIFN/RBV alone.~   "
169734|NCT01343875|"~     Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the~     art treatment is surgical procedure.~      Objective: Evaluation of the Surgical procedure among patients that suffered from Methods:~     The investigators will review files from 2003-2010 of patients that gone through the~     operation. The investigators will record pre-operation and post-operation process including~     complications and rehabilitation. The investigators will invite them to the clinic for exams,~     clinical questionnaires.~   "
169735|NCT01343862|"~     In this study of patients with moderate traumatic brain injury with frontal brain contusions~     patients will be randomized to treatment with a single dose of either D-cycloserine or~     placebo given 48-72 hours after injury.~      Patients will undergo intensive neurocognitive testing at 3 and 6 months after injury to~     assess whether treatment with a single dose of D-cycloserine improves cognitive outcome after~     moderate brain injury.~   "
174228|NCT01284543|"~     The Tan EndoGlide device results in less endothelial cell trauma during insertion of the~     donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared~     to the Busin glide.~   "
169736|NCT01343849|"~     Intend of use: A blood test for Cancer Associated Auto Antibodies (CAAA) aimed for better~     diagnostic management of suspected subjects with breast pathology~      Study Description: Blood is collected form patients and serum is tested for the presence of~     CAAA on experimental test kit.~      Objectives: To assess the effectiveness of the CAAA test.~      Patient Population: The study population will include any women with suspected breast mass~     detected by any conventional method, scheduled for biopsy, which will result with a~     pathological verification of the suspected mass.~      Target Population: The target population will be any women with suspected breast mass~     detected by any conventional method, that today, is scheduled for biopsy.~      Structure: Subjects that will be enrolled for the study will be checked for the presence of~     CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the~     physicians in the participating centers.~      Sample Size: Total of 1000 samples, of which 620 samples will ensure at least 124 true~     positive breast cancer subjects verified by biopsy, and 124 true negative breast cancer~     subjects verified by biopsy. Additional 400 samples will be used for calibrations and~     training sets.(Multi center study, statistical rationale provided below).~      Primary Effectiveness Variables: The effectiveness of the test will be defined by the~     specificity of the test conditionally that the sensitivity is not lower than a pre-defined~     level of 95%.~      Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%.~      Study Sponsor: Eventus Diagnostics Ltd.~      Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical~     trials. All data will be stored in a protected internet-based database, and any changes of~     the data will be traced and recorded.~   "
169737|NCT01343836|"~     This study is designed to compare the treatment of 2 groups in patients with Achilles~     tendinopathy: autologous tenocytes injection in combination with exercises versus saline~     injection in combination with exercises~   "
169738|NCT01343823|"~     A double-blind, randomized, controlled trial comparing the safety and effectiveness of~     conventional therapy with ecallantide to conventional therapy with placebo.~   "
169739|NCT01343810|"~     The goal of this study is to better understand the potential value of reducing stress to~     ameliorate a cluster of biological and behavioral factors implicated in cardiovascular~     disease (CVD) risk. These factors include psychological distress, poor sleep quality, and~     exaggerated physiological responses to emotional stress. Results will be used to develop an~     innovative brief intervention to reduce risk for CVD by improving sleep quality, ameliorating~     psychological distress, and attenuating stress physiology.~   "
169740|NCT01343797|"~     The aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups :~     FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose.~   "
169741|NCT01343784|"~     The purpose of this study is to compare the incidence of catheterization from discharge to 6~     weeks postoperatively when using two methods of post-operative voiding evaluation after a~     mid-urethral sling procedure. The investigators' results may lead to a decreased use of~     indwelling catheters and their associated morbidity after outpatient sling surgery.~   "
169742|NCT01343771|"~     The following randomized controlled trial will examine the effects of one year of~     dehydroepiandrosterone and estrogen replacement therapy (DHEA +ERT) on bone mineral density~     (BMD) and bone marrow composition in adolescents with anorexia nervosa (AN). The~     investigators will use imaging techniques including dual-energy x-ray absorptiometry (DXA),~     peripheral quantitative computed tomography (pQCT), visual assessments of magnetic resonance~     imaging (MRI) data, MR relaxometry and magnetic resonance spectroscopy (MRS) to measure bone~     mineral density and evaluate bone marrow composition. The investigators will also collect~     serum to measure hormonal mediators of the changes observed in both bone density and bone~     marrow composition, including adrenal and gonadal steroids, insulin-like growth factors,~     growth hormone, and ghrelin, adiponectin, and leptin.~   "
169743|NCT01343758|"~     Infants and young children often become infected with gastroenteritis leading to vomiting and~     diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric~     Emergency Department. These children are often in need of treatment with intravenous (IV)~     fluids. While the investigators know that IV fluids work, it is not clear which type or how~     much fluid is the best amount to give. Currently, the most common type of IV fluid given is~     salt water, also called normal saline.~      In contrast to adults, infants and young children with dehydration often have a build up of a~     certain type of acid in their blood which can perpetuate the nausea, vomiting, and general~     malaise associated with gastroenteritis. The investigators feel that giving these children IV~     fluids with lots of sugar (in addition to the salt) reduces the acid more rapidly than giving~     just salt water alone. In a prior study, the investigators have shown that children who~     receive lower amounts of sugar in the IV fluids return to the Emergency Department more often~     for a second visit. Based on this study, the investigators believe that children who receive~     the sugar-salt solution will do better than children who receive just normal saline.~      The investigators will determine if the sugar-salt solution is better by giving equal numbers~     of children the sugar-salt solution and normal saline and then see what happens to each~     child. The investigators will monitor who needs to be admitted, how much each child vomits,~     how much each child drinks, and also the level of acid in the blood before and after getting~     the IV fluid. After the study is completed, the investigators can compare the two different~     groups (children who received the sugar-salt solution versus children who received normal~     saline alone) to determine if one group had greater improvement and better clinical outcome~     than the other.~   "
169744|NCT01343745|"~     The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in~     the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative~     Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated~     after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an~     Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose~     response.~   "
169745|NCT01343732|"~     The purpose of this study is to test whether the combination of deep transcranial magnetic~     stimulation (DTMS) treatment with customary medication for obsessive compulsive disorder~     (OCD) patients is effective than treatment that include only medication.~   "
169746|NCT01343719|"~     The objective of the current study is to investigate safety, tolerability, and~     pharmacokinetics of treatment with BI 661051 rising single doses administered as oral~     drinking solution (powder in bottle) in healthy male subjects.~      The primary objective is to investigate the safety and tolerability of treatment with BI~     661051.~      The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051,~     (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI~     661051 is administered as tablet at two dose levels compared to oral drinking solution and~     (4) to assess the effect on the bioavailability when BI 661051 is administered as oral~     drinking solution after intake of a high fat meal.~      Pharmacodynamic parameters will not be determined within this study.~   "
169747|NCT01343706|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 409306 in healthy male genotyped volunteers following oral administration of single rising~     doses.~      The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate~     release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when~     administered as immediate release solid oral dosage compared to oral drinking solution and~     (3) to compare the safety and pharmacokinetic profiles between two different groups of~     genotyped subjects.~   "
169748|NCT01343693|"~     This study is being performed to document the outcomes of subjects using our MaxAn Anterior~     Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for~     2 years.~   "
169749|NCT01343680|"~     The purpose of this study is to determine whether flushing Central Venous Catheters (CVCs)~     with Normal saline once per week is not inferior to flushing with 10U/ml heparin 3 times per~     week, in preventing CVC occlusions.~   "
169750|NCT01343667|"~     The objective of this study is to provide an ongoing evaluation of clinical outcomes~     associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for~     embolic protection during carotid artery stenting.~   "
169751|NCT01343654|"~     The investigators will develop and test the feasibility and promise of a combined HIV~     adherence assessment and intervention application for rural drug users using an available,~     familiar technology whose reach will grow exponentially: text messaging via mobile phones. By~     2007, 84% of U.S. residents had mobile phones, with near 100% mobile phone penetration~     projected by 2013. While technology adoption is often slower in under-served communities, the~     trend is different with mobile phone technology. African-Americans are using more mobile~     phone minutes per capita and increasing their use at a higher rate compared with other ethnic~     groups. This technology has great potential to reduce health disparities. In this project,~     the investigators will develop and test the feasibility and promise of a text messaging~     application and system using Ecological Momentary Assessment methods to detect nonadherence~     and drug use and immediately intervene to improve HIV treatment adherence in drug users~     living with HIV/AIDS who reside outside major metropolitan areas. This R34 is a Stage 1b/2a~     project in the Stage Model of Behavioral Therapy Development that will develop novel~     interventions and methods, and generate preliminary estimates of effect sizes that will~     determine whether a larger clinical trial with extended follow-up and cost-effectiveness~     evaluation is warranted.~      The specific aims of this project are:~        1. To identify assessment and intervention features relevant to the adherence barriers and~          drug use patterns of rural and non-urban HIV+ drug users using formative methods~          including:~             -  structured interviews and focus groups to identify specific barriers to adherence~               and engagement in care and needs related to drug craving and drug use that should~               be addressed by the intervention~             -  iterative usability testing of components and drafts of the intervention~        2. To create a text messaging mobile phone application and system (Treatment Extension by~          Texting, Text) to assess and improve HIV treatment adherence and drug use in real time~           --Text will be built upon a piloted unidirectional personalized text phone application~          and system, STeM, and will include pre- and post-programming usability testing~        3. To test the feasibility and promise of the assessment and intervention tool in a~          randomized pilot trial of rural HIV+ drug users with detectable viral load (VL)~          comparing Text to usual care~             -  Feasibility: Identify recruitment rates, consent rates, participant flow,~               completion rates, and variance of key covariates and outcome variables~             -  Promise: determine point estimates and the precision of effects for primary and~               secondary adherence outcomes including pharmacy refills and unannounced pill counts~               (medication adherence), missed visit percentage (treatment engagement), VL, and~               drug craving and drug use.~   "
169752|NCT01343641|"~     This year-long investigator-initiated study is designed to determine effects of MK-0677, a GH~     secretagogue, in renal patients. It is a double-blind, placebo-controlled trial employing the~     following procedures: Informed consent process, followed by evaluation and screening tests to~     confirm patients' eligibility. Patients whose screening laboratory results for glycated~     hemoglobin level, thyroid function, or liver function exceed protocol eligibility criteria~     will not be randomized. Other exclusions are Congestive Heart Failure Class III or IV by the~     New York Heart Assocation's (NYHA) Guidelines and specified cardiovascular disorders within~     six months of baseline visit and muscle weakness associated with neuromuscular or~     neurological disorders. Before the subject begins taking the experimental drug MK-0677 or~     placebo, baseline assessments of subjects' hormone and cytokine levels, physical condition,~     body mass (determined by a DEXA scan), strength and functionality, and appetite will be~     obtained. In addition, quality of life assessments (SF-36) will be administered. This study's~     primary outcome is an increase in lean body weight. Secondary outcomes are cytokine and~     hormone levels, including, leptin, insulin, ghrelin, TNF- alpha, CRPs, IL-1, IL-6, and IL-10,~     ghrelin associated esterase and adiponectin, nutritional status, quality of life (QoL), food~     appreciation, physical function and economic impact. 70 subjects will be the enrollment~     target. This number was determined to offset projected screen failure and early withdrawal~     rates, and to ensure that 42 subjects complete the study.~   "
169753|NCT01343628|"~     Alcohol dependence, or alcoholism, affects approximately 14 million Americans. Currently,~     only three pharmacotherapies (disulfiram, naltrexone, and acamprosate) have been approved for~     the treatment of alcohol dependence and these medications are, at best, moderately~     successful. Thus, there is a great need for the examination of other biological systems,~     which contribute/influence the drug reward/addiction pathways within the brain, such that the~     discovery of new targets and new pharmacotherapies will be possible. Other biological systems~     in addition to dopamine, such as serotonin, and norepinephrine (NE) are thought to be~     important in several aspects of addiction, including reward, craving and depression.~      This study will examine the effects of a 5 day course of atomoxetine (a selective NE~     transporter (NET) inhibitor) (80 mg/day; Strattera or placebo) on alcohol-elicited craving~     and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the fact~     that it targets NET, neither of which has heretofore been examined in the context of alcohol~     dependence. It is hopeful that this study, of 64 total individuals, will provide the PI with~     sufficient preliminary data to submit a subsequent R01 application to study atomoxetine and~     the involvement of specific single nucleotide polymorphisms within the NET gene on~     alcohol-related phenotypes in alcohol dependent and non-dependent populations. The long-term~     objective of this research is to develop more efficacious treatment interventions for alcohol~     abuse and dependence.~   "
169754|NCT01343615|"~     The purpose of this study is to determine the clinical and radiologic implications of the~     intraoperative microemboli during carotid revascularization.~   "
169755|NCT01343602|"~     The aim of this study is to evaluate the efficacy of a modified approach of constraint~     induced movement therapy (CIMT at home) for chronic stroke patients, compared to~     conventional physiotherapy and occupational therapy (therapy as usual) with regard to the~     ability to participate in everyday activities.~   "
169756|NCT01343589|"~     To investigate the effect of milk delivered from mountain-pasture grazing cows on risk~     markers of the metabolic syndrome and type-2 diabetes with the effect of conventional Danish~     milk. The study should reveal the importance of phytanic acid content for these effects.~   "
169757|NCT01343576|"~     The aim of the study is to investigate if cow feeding regimes affects concentration of plasma~     phytanic acid and risk markers of the metabolic syndrome in human.~   "
169758|NCT01343563|"~     This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an~     adjunctive treatment for adults with major depressive disorder (MDD) when added onto~     antidepressant medications. Our primary objective is the examination of two different doses~     of TNS, in terms of pulse frequency.~      To accomplish our specific aims, the investigators will test the following specific~     hypotheses:~        1. Subjects will show greater improvement in ratings of mood and other symptoms of~          depression during the six-week of high frequency stimulation than during low frequency~          stimulation periods.~        2. Subjects will show greater improvement after 12 weeks of high frequency stimulation than~          after six weeks of high frequency stimulation.~        3. Subjects will show improvement in ratings of life functional capacity and quality of~          life with TNS.~        4. Subjects will report the TNS treatments to be acceptable in terms of side effects and~          burden of using the device.~        5. Subjects will show significant differences in regional brain function at the end of the~          high frequency stimulation period compared with baseline, and significant differences~          between high and low frequency stimulation conditions.~   "
169759|NCT01343550|"~     The investigators hypothesize that a creativity skills group for Borderline Personality~     Disorder can reduce symptoms of BPD, depression, and anxiety.~   "
169760|NCT01343537|"~     Aneurysmal subarachnoid hemorrhage (bleeding on the brain due to a ruptured aneurysm) is a~     serious condition with a high morbidity (incidence of having ill health) and mortality~     (death). There are approximately 11 cases per 100,000 in the population per year, and~     approximately 40% of these cases are fatal. (Ingall) Among the fortunate subjects who survive~     the initial bleed, vasospasm and subsequent stroke are a major cause of morbidity. Vasospasm~     is defined as a prolonged severe, although reversible cause of arterial narrowing that occurs~     after bleeding into the subarachnoid space, most commonly after aneurysmal rupture. (Youman)~     The reduced arterial diameter inhibits blood flow and deprives the brain of oxygen, which~     often results in a stroke.~      Vasospasm is a major problem when treating subjects with aneurysmal subarachnoid hemorrhage.~     For these reasons, it is essential to diagnose cerebral vasospasm early, before permanent~     deficits develop.~      There may be another option to solve this dilemma. The field of neuro-monitoring~     (neurological monitoring) has the technology available to continuously monitor brain activity~     of these sedated ICU subjects. This may allow for early diagnosis and possibly identify~     changes in neurologic function before they become symptomatic. In the past, neuro-monitoring~     was primarily used in the operating room to monitor neurologic function during surgery in and~     around the spinal cord. Surgery to the spine or spinal cord also carries its own form of~     risk, either from mechanical trauma to the spinal cord or its nerve roots, or from~     interruption of the blood supply to these structures. Should damage to nerve fibers occur,~     the end result could be paralysis, loss of sensation, and onset of severe burning (i.e.~     neuropathic) pain. The field of intraoperative neuro-monitoring (IOM) was developed to~     address these risks during spine surgery, whereby nerves rostral (toward the head) or caudal~     (toward the feet) to the site of surgery are stimulated (usually via electrical pulses) and~     signals are recorded from the side opposite to the site of stimulation. Thus, the signals~     carried by nerve fibers are forced to pass through the region at risk from the surgery. In~     the event that changes in nerve responses are seen, the surgical team is notified, and they~     can change what they're doing to try and restore signals, thereby preserving function in the~     nerve fibers.~      This same technology has been used in the neurosurgical ICU to monitor subjects with severe~     brain injury from trauma, stroke, intracranial hemorrhage and subarachnoid hemorrhage. Using~     continuous electroencephalogram (EEG) monitoring combined with somatosensory evoked~     potentials (SSEPs) (a type of neuro monitoring) has been used to determine prognosis,~     identify subjects in subclinical status epilepticus (state of brain being in a constant~     seizure), predict elevations in the intracranial pressure Increased pressure within the~     skull), and diagnose cerebral hypoxia (not enough oxygen in the brain) (Amantini)~   "
169761|NCT01343524|"~     The investigators' Upstate Cystic fibrosis (CF) Care Center is very active in research. For~     example, in 2009, 68 of our 135 pediatric patients have been participating in 16 clinical~     trials. Sponsors often provide their study sites with spirometers to use for PFTs. These~     machines are meant to provide uniform PFTs results for studies, which include measurement of~     FEV1 values. In 2009, among the 52 patients at our Center who are 6-12 years old, 20 (38%)~     have been in studies with sponsor-provided spirometers. Among the 32 patients ages 13-17~     years, 13 (40%) have been in studies with sponsor-provided spirometers. Anecdotally, the~     investigators have noted that FEV1 results obtained during clinical trials for our patients~     appear to be lower than those of our patients' usual values, especially with younger~     children. The investigators hypothesize that the apparent difference in PFT results might be~     related to the different incentives (if any) provided by study PFT equipment. Further, if~     this difference exists, the investigators believe that this may account for the apparent~     average decline in the lung function results of our patients over the recent years, given the~     large proportion of our patients who participate in clinical trials. Finally, the~     investigators hypothesize that younger children may be more affected by the difference in~     incentives than older ones.~      The purpose of this study is to collect an additional set of Pulmonary Function Tests (PFTs)~     using our regular clinic equipment, on all study subjects following their study PFTs if these~     are done with sponsor-provided equipment. The investigators will compare the results from~     both types of machines and report regarding differences identified.~   "
169762|NCT01343511|"~     Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by~     social interaction abnormalities, impaired verbal and non-verbal communication, and~     repetitive, obsessive behavior, while the therapeutic effect of current treatments remains~     limited progress .Neural hypoperfusion and immune deregulation are the two key pathologies~     associated with Autism. Human umbilical cord mesenchymal stem cells (hUC-MSCs) and human cord~     blood mononuclear cells (hCB-MNCs) have been shown to have the ability to modulate the immune~     response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy.~     In this study, the safety and efficacy of hUC-MSCs and hCB-MNCs transplantation will be~     evaluated in patients with Autism.~   "
169763|NCT01343498|"~     This is a dose escalation trial to evaluate twice daily dosing of the sachet formulation of~     BEZ235. This trial will find the maximum tolerated dose (MTD) of the sachet formulation given~     twice daily, as well as evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of the twice~     daily dosing. Patients will initially be given once daily dosing to determine the PK and PD~     of the single daily dose. On Day 9, they will begin twice daily dosing, with half of the~     single daily dose divided twice daily, and PK and PD of the twice daily dose will be~     determined.~   "
169764|NCT01343485|"~     Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a~     prospective, cluster randomized trial to determine which factors influence the acquisition of~     the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to~     26. This descriptive and interventional study will provide data to assess impact of a~     computerized tool upon HPV vaccine series completion. The interventional aspect of this study~     includes determination of patient assistance and provider support programs applicable to each~     woman's situation as well as the implementation of a computer software system for customized~     patient reminders.~   "
169765|NCT01343472|"~     This study entails an evaluation of the Washington Intensive Supervision Program (WISP). The~     purpose of the evaluation is to test whether subjects assigned to WISP perform better than~     those assigned to parole-as-usual (PAU).~   "
169766|NCT01343459|"~     Title:~      HIOB - Hypofractionated Whole-Breast Irradiation preceded by Intraoperative Radiotherapy with~     Electrons as anticipated Boost ISIORT- 01~      HIOB is defined as hypofractionated WBRT (40,5 Gy in 2,7 Gy per fraction) preceded by an~     Intraoperative Boost to the tumor bed ( 90 % reference dose of 10 Gy, 11,1 Gy Dmax IOERT).~      Primary endpoint is the proof of superiority of a new treatment regimen.~      The HIOB study concept is supposed to test the hypothesis whether such a combined schedule is~     superior (or iso-effective) towards standard RT in terms of local control and cosmetic~     outcome.~      In the vast majority of all publications, annual and 5 year in-breast recurrence rates~     following BCT showed a clear dependency on patient age within the following boundaries~     (primary references):~      Age > 50: Bartelink (standard): 0,7% (annual) 3,5% (5y) START B (best): 0,4 %(annual) 2,0%~     (5y)~      Age 41-50: Bartelink (standard) 1,2% (annual) 6,0% (5y) Whelan (best) 0,72%(annual) 3,6% (5y)~      Age ≥ 35-40 Bartelink (standard) 2% (annual) 10% (5y) Whelan (best) 0,72% (annual) 3,6% (5y)~      long these three different age groups, benchmarking will be performed against the best~     published results following `Golden Standard`RT, usually defined as conventionally~     fractionated WBRT with 50 Gy (25 x2) plus external tumor bed boost with 10-16 Gy electrons~     (5-8x2Gy).~      Superiority is defined as going below the lower limit of the estimated 5 year local~     recurrence rate within the respective age group Inferiority is defined as crossing the~     respective upper limit .~      Secondary endpoint:~      Disease free survival~      Tertiary endpoint: toxicity assessment (acute and late) including long term cosmetic~     evaluation~      Study design and statistics:~        -  Prospective multicenter single-armed~        -  Sequential probability ratio test (SPRT)~        -  Separate analysis within three different age groups~      Estimated Accrual time: strongly dependent on recruitment per year within the respective age~     group . Due to the statistical estimation of Szenario A and B the study will close after max.~     Time-period of 10 years in case of A or 6,4 years in case of B..~      Principal investigators and study coordinators:~      UC of Radiotherapy and Radio-Oncology UC of Special Gynecology and Breast Cancer Center~     Landeskrankenhaus Salzburg, Paracelsus University Clinics~   "
169767|NCT01343446|"~     To examine the effect of sleep impairment on coping style of patients with diabetes~   "
169768|NCT01343433|"~     Our purpose of this study is to determine whether bright light therapy is effective for~     reducing the incidence and the duration of delirium compared to the usual treatment in~     patients at the Intensive Care Unit. Our hypothesis is that bright light therapy is effective~     for reducing the incidence and duration of delirium in patients at the Intensive Care Unit~      Patients will be assigned to a chamber with or without bright light therapy. This assignment~     is based on occupation of ICU beds and availability of nurses and is therefore independent~     from patients characteristics. Patients will be included following the inclusion criterion~     and exclusion criteria. Patients assigned to a chamber with bright light therapy will receive~     light therapy for three hours in the morning, from eight o'clock till eleven o'clock. The~     Confusion Assessment Method-score (CAM-score) and the Richmond Agitation Sedation Scale-score~     (RASS-score) will be performed three times at one day by ICU nurses, this is according to the~     existing routine. Besides this, an extra CAM-score and a clinical assessment will be~     performed once a day by a trained non-clinician, to determine the presence of delirium. The~     use of sedatives, haldol and fixation will be registered to determine the occurrence,~     duration and severity of delirium. Eventually the most important outcomes will be the~     clinical assessment of the patients, the CAM-score and the use of haldol. The primary outcome~     of this study is the duration of delirium, defined in number of days.~   "
169769|NCT01343420|"~     Liquid allergen extracts contain proteins, such as (but not limited to) tree, weed, cat,~     cockroach, and nuts, and are used to identify allergies by observing the body's reaction to~     the introduction of extract underneath the skin. There are a few dog allergen extracts~     commercially available in the US for allergy testing; however, none of these products are~     standardized, meaning they are not required to be the same strength. Because some extracts~     are not as potent (strong) as others, it's possible that some patients' allergies are~     misdiagnosed. Typically, the most potent (strong), but safe extract should be used so that~     allergic patients are correctly diagnosed.~      The purpose of this study is to compare the safety and potency of an investigational (not~     approved for use by the United States Food and Drug Administration [FDA]) dog allergen~     extract with two commercially available dog extracts, which are of differing potencies.~   "
169770|NCT01343407|"~     Part I of the study will verify optimal execution of the procedures and acquisition of~     satisfactory samples that will be utilized in the main study (Part II); no drug will be~     administered. Part II will assess the effect of multiple doses of MK-1029 on the changes in~     allergen-induced sputum eosinophils and changes in allergen-induced late asthmatic response~     (LAR) when compared to placebo.~   "
169771|NCT01343394|"~     The objectives of this study are:~        1. To see if autologous human umbilical cord blood treatment is safe for children with~          acquired hearing loss, and~        2. To determine if late functional outcome is improved following autologous human umbilical~          cord blood treatment for children with acquired hearing loss.~   "
169772|NCT01343381|"~     Heparin, a blood thinner, is used routinely in Open-heart surgery. Do different brands of~     this drug have differing clinical effects despite both having exactly the same regulation and~     marketing specifications?~   "
169773|NCT01343368|"~     Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive~     GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be~     observed.~   "
169774|NCT01343355|"~     An open-label, non-randomised, uncontrolled, proof-of-concept study of patients with~     HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Participants will~     receive oral administration of tamibarotene in the amount of 2 mg daily over a period of 12~     weeks, then 4mg daily for another 12 weeks. The patients will be followed up for further 8~     weeks. Efficacy will be monitored by measuring clinical scores including motor and urination~     function, HTLV-1 proviral load, immunological parameters, and markers in the spinal fluid.~     Safety will be evaluated at the same time.~   "
169775|NCT01343342|"~     The main purpose of this study is to examine whether n-3 PUFA-induced changes in metabolic~     risk factors are influenced by genetic variations within genes acting as fatty acids sensors.~   "
169776|NCT01343329|"~     Traumatic brain injury (TBI) is frequently associated with a hyperadrenergic state~     accompanied by elevated levels of plasma catecholamines. In its more severe presentation, the~     hyperadrenergic state presents as dysautonomia, which is characterized by paroxysmal~     alteration in vital signs, including tachycardia. The investigators hypothesize that~     intravenous (IV) esmolol is as effective at controlling heart rate in hyperadrenergic states~     as oral propranolol, which is the standard of care. Our primary endpoint is efficacy of IV~     esmolol vs a PRN regimen of intermittent B-blockade in controlling heart rate below a~     pre-specified level (< 100 bpm) after Traumatic Brain Injury (TBI) or hemorrhagic neurologic~     injury. Heart rates will be recorded continuously as well as hourly.~   "
169777|NCT01343316|"~     The purpose of this study is to determine the benefit of feeding critically-ill patients~     beyond the stomach (post-pyloric). Furthermore, because of the advent of two new post-pyloric~     feeding tubes (Tiger 2 and Syncro BlueTube) designed to improve post-pyloric placement, the~     investigators will be evaluating the benefits of those two tubes as well.~   "
169778|NCT01343303|"~     The purpose of this study is to evaluate the safety of multiple oral doses of JNJ-39439335~     and to assess how JNJ-39439335 is absorbed (taken in), distributed, metabolized (broken~     down), and eliminated from the body (referred to as pharmacokinetics) in osteoarthritis~     patients. This study will also assess the effectiveness of JNJ-39439335 on pain.~   "
169779|NCT01343290|"~     The purpose of this study is to assess the effect of food on the absorption of canagliflozin~     in the body when canagliflozin is taken with and without food by healthy volunteers~   "
169780|NCT01343277|"~     The purpose of this study is to evaluate whether overall survival for the trabectedin group~     is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or~     leiomyosarcoma).~   "
169843|NCT01342445|"~     The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a~     prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college~     students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students~     with ADHD from two universities (University of Rhode Island and Lehigh University) completed~     a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral,~     psychosocial, and academic functioning were completed on a weekly basis across five~     conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).~   "
169781|NCT01343264|"~     The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is~     still controversial. The selection criterion to perform either Extrapleural Pneumonectomy~     (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status~     of the patient, tumor stage and intraoperative findings but also on surgeons' decision and~     philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against~     EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment~     options. The aim is to remove all gross disease and to achieve macroscopic complete~     resection.~      Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing~     surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP~     in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM~     are based on retrospective analyses and their interpretation is difficult because of~     inhomogeneous patient groups studied.~      The aim of our study was to analyze the feasibility and results of RP as surgical therapy~     modality in a standardized trimodality therapy concept.~   "
169782|NCT01343251|"~     The main objective of this research study was to compare the following outcomes between~     patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed~     catheter for dialysis access over one year: quality of life and incidence of bacteremia,~     vascular interventions, hospitalizations, and death.~   "
169783|NCT01343238|"~     The study will investigate whether physical exercise, or dietary restrictions, or a~     combination of both, among overweight and obese postpartum women lead to a significantly~     larger reduction in weight in a longer perspective, compared to similar women not receiving~     the intervention. The study also will investigate the effects on body composition,~     cardiovascular fitness, blood lipids, insulin levels and inflammation markers. In total, 68~     women with pre-pregnancy BMI 25 - 34.9 will be randomized at 10 wk postpartum into: (1)~     physical exercise, (2) dietary restrictions, (3) physical exercise + dietary restrictions and~     (4) control group. The intervention lasts for 12 wk and longterm effects are measured 1 yr~     after trial initiation. To date only studies showing short term (12 wk) effects exist. Our~     study is the first to include four intervention groups, so that separate effects of physical~     activity and dietary restriction and their interaction, can be assessed. Further, the~     investigators will estimate effects on body composition taking body water into account and~     estimate total energy expenditure with higher precision than previously. Overweight and~     obesity is an escalating problem in Sweden. Sustainable weight reduction programs are~     urgently needed. During the postpartum period, women may be motivated to lose weight.~     Information aimed at promoting life style changes among overweight and obese women could in a~     longer perspective be integrated in the regular maternal health care in Sweden.~   "
169784|NCT01343225|"~     2. Objectives~        1. To determine the vitamin D status of African-American HIV patients who are HIV-treatment~          naïve.~        2. To compare the effects of an efavirenz-containing regimen to a protease inhibitor~          regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.~        3. To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen~          to a regimen that does not contain these drugs.~        4. To compare the efficacy of an alternative regimen (raltegravir, darunavir, ritonavir) to~          a standard once-daily regimen (tenofovir-emtricitabine-efavirenz).~      Hypothesis~      The investigators hypothesize that patients receiving efavirenz will be more likely to have~     lower 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3levels based on the fact that efavirenz~     is an inducer of CYP3A4 and CYP24 enzymes that degrade 25-hydroxyvitamin D and 1,25~     dihydroxyvitamin D3, respectively, to inactive metabolites. The investigators speculate that~     patients on a tenofovir-containing regimen will be more likely to have progression of bone~     density loss compared to those in the non-tenofovir-containing regimen.~   "
169785|NCT01343212|"~     The investigators are measuring hepatocellular carcinoma(HCC)stiffness using Acoustic~     Radiation Force Impulse (ARFI) technique to enhance the diagnostic accuracy for HCC~     stratifications and treatment efficacy.~   "
169786|NCT01343186|"~     This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of~     Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose~     at different levels.~   "
169787|NCT01343173|"~     Background: Complete molecular remission under imatinib, therapeutic interruption possible~     for patients in complete remission proved in different trials.~      Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular~     remission during two following years. The objectives of this study are to determine the rate~     of patients without a molecular relapse and so the rate of molecular relapse, to determine~     and to seek for clinical and biological CML-related factors predictive for a molecular~     relapse after imatinib discontinuation. These objectives require to increase the number of~     study patients to be enrolled for accurate statistical considerations. It will allow to~     predict which patients have to be proposed for discontinuation without risk of molecular~     relapse and to select the patients who need to continue or reinforce the treatment to achieve~     a complete long term eradication of the disease.~   "
169788|NCT01343160|"~     Generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the~     endoscopic and percutaneous treatment of benign biliary strictures.~   "
169789|NCT01343147|"~     Heat therapy is frequently prescribed to patients with symptomatic knee osteoarthritis (OA).~     Deep hyperthermia via localized microwave diathermy is effective in several musculoskeletal~     painful conditions. However, the efficacy of superficial heating is controversial.~     Furthermore, no clinical trials have yet directly compared the effects of these treatment~     modalities in knee OA. Hence, the purpose of the present study is to compare the effects of~     deep and superficial hyperthermia, induced via microwave diathermy and hot packs,~     respectively, on pain and function in patients with symptomatic knee OA.~   "
169790|NCT01343134|"~     The purpose of this study is to evaluate the correlation between morphologic changes in the~     outer retina and visual function after successful repair of rhegmatogenous retinal detachment~     with macula off.~   "
169791|NCT01343121|"~     The purpose of this study is to test the hypothesis that plasma, peripheral blood mononuclear~     cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours post infusion,~     predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of~     radiotherapy.~   "
169844|NCT01342432|"~     The purpose of this study is to compare the effects of a balance reeducation protocol and an~     evidenced based protocol on pain, function and postural control of low back pain patients.~   "
169793|NCT01343095|"~     This study seeks to examine the effects of overnight noise reduction in critically ill~     patients who are receiving mechanical ventilation. The investigators will randomly place~     subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs~     and noise-canceling headphones. The investigators will monitor for safety, and will measure~     the amount of delirium experienced by subjects, record the amount of sedating and painkilling~     medicines required, and measure sleep quality during the study, among other information. The~     investigators will also measure noise levels experienced by patients in each group. The~     investigators predict that the use of overnight noise reduction will be safe and will reduce~     the amount of delirium by improving the quality of sleep in critically ill patients.~   "
169794|NCT01343082|"~     Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be~     evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label,~     multicenter study.~   "
169795|NCT01343069|"~     The study investigates the impact of the introduction of a surgical checklist on the~     incidence of complications and mortality within 30 days after surgery in patients scheduled~     for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting~     longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care~     center. Study design is an open trial before and after intervention (implementation of the~     checklist safe surgery saves lifes).~   "
169796|NCT01343056|"~     Patients who receive DSME (Diabetes Self Management Education) will be enrolled in a 4 arm,~     randomized study with each group receiving a different method of follow up. The 4 arms will~     be evaluated based on clinical indicators, goal achievement and patient satisfaction.~   "
169797|NCT01343043|"~     The purpose of this early (pilot) clinical trial is to test the effects (both good and bad)~     of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1~     peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.~   "
169798|NCT01343030|"~     Breast implants are currently used for cosmetic breast augmentation and in breast~     reconstruction following mastectomy for breast cancer. Fat grafting is a technique where fat~     is injected around the periphery of a breast implant to camouflage the transition between~     implant and the body. The investigators propose to show mammography images of women who have~     had breast implants with fat grafting to informed and blinded radiologists and evaluate their~     readings of the images.~      Hypothesis: with mammographic screening, radiologists will be able to distinguish between~     findings associated with fat grafting and those which are suspicious for breast cancer.~   "
169799|NCT01343017|"~     General anaesthesia impairs respiratory function in overweight patients. The investigators~     wanted to compare arterial concentration of sevoflurane and oxygen in overweight patients~     ventilated with increased tidal volume, or normal tidal volume with added 10 cm H2O PEEP.~   "
169800|NCT01343004|"~     The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid~     hormone-related peptide, is effective in preventing fractures in postmenopausal women with~     severe osteoporosis who are at risk of fractures.~   "
169801|NCT01342991|"~     This is a randomised trial to compare both the procedures and the difference in their~     immediate postoperative pain, recovery and quality of life.~   "
169802|NCT01342978|"~     This research is being done to understand more about a sexually transmitted virus called~     Human papillomavirus (HPV) in people with oropharyngeal cancer and their partners.~   "
169803|NCT01342965|"~     This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva~     (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in~     patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor~     (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg~     orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8~     plus cisplatin 75 mg/m^2 iv on Day 1.~   "
169804|NCT01342952|"~     An open label, long term extension to Study AMB112529. All subjects may remain in the~     extension study for a minimum of six months. Beyond the six month period, subjects may~     continue in the extension study until one of the following conditions is met:~      the subject turns 18 years of age (when the subject can receive marketed product) the product~     is approved and available for use in the subject's age group, development for use in the~     paediatric population is discontinued. the subject decides he/she no longer wants to~     participate in the study, the investigator considers it is in the best interest of the~     subject to discontinue ambrisentan (e.g. for safety reasons).~      The primary objective is the long-term safety and tolerability of ambrisentan in the~     paediatric PAH population. Secondary objectives are all cause mortality and change from~     baseline in Study AMB112529 on efficacy parameters.~   "
169805|NCT01342939|"~     The purpose of this study is to describe the incretin effect and postprandial incretin~     response in patients with MODY2 and MODY3 and a group of matched healthy subjects. In~     sulphonyl urea treated subjects the purpose is also to compare the incretin effect with and~     without treatment. In healthy subjects the purpose is also to investigate the incretin effect~     under increased levels of endogen incretin hormones.~   "
169806|NCT01342926|"~     The purpose of this study is to determine the safety and efficacy of GSK933776 in the~     treatment of geographic atrophy secondary to age-related macular degeneration.~   "
169807|NCT01342913|"~     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone~     Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate~     50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.~   "
169808|NCT01342900|"~     Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk~     surgical patients may decrease the risk of postoperative complications.~      Tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The~     investigators want to see if an algorithm aimed at optimizing intraoperative tissue~     oxygenation reduces perioperative complications as well as length of stay in the intensive~     care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these~     patients.~   "
169845|NCT01342419|"~     This single-center, investigator-masked, crossover study is designed to investigate the~     circadian rhythms of aqueous humor dynamics in human subjects with ocular hypertension (OHT)~     before and after intervention with a commonly used ocular hypotensive medication,~     brimonidine.~   "
169809|NCT01342887|"~     This phase I/II trial studies the side effects and best dose of etoposide and mitoxantrone~     hydrochloride when given together with cyclosporine and pravastatin sodium and to see how~     well they work in treating patients with relapsed or refractory acute myeloid leukemia (AML).~     Cyclosporine may inhibit efflux of cancer drugs out of cancer cells and may thereby improve~     chemotherapy treatment for AML. Pravastatin sodium may stop the growth of cancer cells by~     blocking some of the nutrients needed for cell growth. Drugs used in chemotherapy, such as~     etoposide and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving cyclosporine~     together with pravastatin sodium, etoposide, and mitoxantrone hydrochloride may kill more~     cancer cells~   "
169810|NCT01342874|"~     Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus~     (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of~     pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of~     insulin resistance. Dietary supplementation of inositol improves insulin resistance in~     patients with GDM.~   "
169811|NCT01342861|"~     Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals~     have created a system of cross-function committees for feeding and nutrition called CLANs~     [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving~     patient nutritional status include improving the characteristics of the food provided to~     increase both protein and calorie intake in at-risk patients that do not require enteral or~     parenteral nutrition. Looking at the various daily meals, the investigators considered that~     breakfast following the night fast would be the easiest meal to improve .~      Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition~     of protein (milky food in the breakfast) Current care~   "
169812|NCT01342848|"~     Although successful, percutaneous coronary interventions (PCI) with stent implantation may be~     hampered by periprocedural myocardial necrosis. In acute ST-elevation myocardial infarction~     (STEMI), the reduction of thrombus burden through manual thrombus aspiration (TA) of an~     occluded coronary artery has been documented to produce an improved myocardial perfusion rate~     and significant survival advantage. To date, beyond feasibility and safety studies no~     clinical benefit has been yet documented with the use of TA before stent deployment in the~     setting of acute coronary syndromes (ACS) outside acute STEMI. The investigators hypothesize~     that TA before stent deployment reduces the thrombus/plaque burden - as assessed by~     intravascular imaging systems - in the setting of acute coronary syndromes (ACS) outside~     acute STEMI.~   "
169813|NCT01342835|"~     The investigators hypothesize that patients anesthetized with sevoflurane have more pain,~     postoperatively, than those anesthetized with propofol.~   "
169814|NCT01342822|"~     The PROMUS Element™ clinical trial (PLATINUM-PLUS) consists of a randomized controlled trial~     (RCT) in the European Union (EU) which will enroll approximately 2980 subjects (2:1~     randomization PROMUS Element™: Xience™ Prime) in a Population of consecutive, all comers in~     the reimbursed indications per-country~      All subjects will be screened per the protocol required inclusion/exclusion criteria.~   "
169815|NCT01342809|"~     The study hypothesis is that follow up from general practitioner after hospitalization for~     self poisoning will decrease suicidal behaviour.~   "
169816|NCT01342796|"~     This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and~     hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit~     influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated~     children aged 6 to <36 months.~   "
169817|NCT01342783|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research trial is studying biomarkers in samples from young patients with soft~     tissue sarcoma.~   "
169818|NCT01342770|"~     This pilot phase II trial studies how well pioglitazone works in treating patients with stage~     IA-IIIA non-small cell lung cancer. Pioglitazone hydrochloride may slow the growth of tumor~     cells and may be an effective treatment for non-small cell lung cancer.~   "
169819|NCT01342757|"~     This clinical trial is studying magnetic resonance spectroscopy imaging in predicting~     response in patients to vorinostat and temozolomide in patients with recurrent, progressive,~     or newly diagnosed glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Vorinostat may also help temozolomide work better by making~     tumor cells more sensitive to the drug. Imaging procedures, such as magnetic resonance~     spectroscopy imaging, may help measure the patient's response to vorinostat and temozolomide~     and allow doctors to plan better treatment.~   "
169820|NCT01342744|"~     The purpose of this study is to determine the effects of metformin on cardiovascular risk~     factors in postmenopausal women with metabolic syndrome.~   "
169821|NCT01342731|"~     30 adult hospitalized patients who have infections due to MDR Acinetobacter baumannii will be~     enrolled. The eligible patients will receive 100 mg of tigecycline intravenous infusion for~     30 minutes followed by 50 mg every 12 hours for 7 to 14 days. Clinical outcomes on~     effectiveness and safety will be evaluated on daily basis up to 28 days. Follow-up culture of~     clinical specimen from the site of infection will be obtained on day 3 and at the end of~     tigecycline therapy. Clinical response is classified as cure, improvement, failure, relapse,~     death. Microbiological outcome is assessed at the end of treatment and classified as~     eradication, persistence, colonization, and superinfection. Adverse events, overall 28-day~     mortality and infection-related mortality will be determined. Length of stay will also be~     determined.~   "
169822|NCT01342718|"~     The aims of this study are to investigate the effect of famous herbal formula extract and~     probiotics on irritable bowel syndrome with diarrhea, and to determine whether these two~     experimental items affect intestinal permeability and the composition of intestinal~     microbiota.~   "
169823|NCT01342705|"~     The main objective of the study is to assess in patients with compensated alcoholic cirrhosis~     and hepatic iron overload (HIO), as assessed by MRI, the effect of phlebotomy in order to~     lower and maintain serum ferritin below 50 µg / l on the risk of hepatocellular carcinoma~     (HCC) occurrence. The effect of bloodletting will be jointly evaluated on 1) episodes of~     hepatic decompensation, 2) non HCC liver-related mortality 3) changes in HIO during~     follow-up.~   "
169824|NCT01342692|"~     In order to improve the overall survival benefit observed with AZA in higher risk MDS, its~     combination with other active drugs in MDS must be tested.~      Among drugs that have demonstrated to be active as a single agent in MDS and have preclinical~     potential additive or synergistic activity with AZA are Histone deacetylase (HDAC) inhibitors~     including Valproic acid, Lenalidomide and idarubicin. Phase I studies have already been~     conducted or are being conducted combining those agents to demethylating agents, showing a~     low toxicity profile and significant responses in high risk MDS. In this phase II randomized~     trial, we want to identify the most promising combination of Azacitidine and another drug~     (among 3 drugs: Valproic acid, Lenalidomide and Idarubicin) in higher risk MDS, by comparison~     to Azacitidine alone. Of note, based on efficacy and toxicity, one or several combinations~     may be stopped, and others, previously tested in phase I trials, included after protocol~     amendment.~   "
169825|NCT01342679|"~     The purpose of this study is to evaluate complete molecular response of Dasatinib in patients~     for Philadelphia chromosome-positive chronic myeloid leukemia~   "
169826|NCT01342666|"~     -  This is a randomized, open-label, single blind, clinical trial~        -  The study evaluated the effect of tomato consumption in serum HDL-cholesterol levels.~        -  The hypothesis was that two daily tomatoes during one month will increase the HDL-c~          levels.~        -  Since a placebo of tomatoes cannot be done, the control group will receive same~          proportion of cucumber because 1) it was not possible to have a tomato placebo; 2)~          cucumber does not have any lycopene; 3) both can be prepared similarly; and 4) the~          required quantity can be measured in the same way.~        -  The intervention was during 1 month and was assigned by randomization.~        -  Personnel who did the clinical and biochemical evaluation were blinded for the~          intervention.~        -  Lipid profile was measured before and after the intervention.~        -  Confounding factors such as daily physical activity, diet, consumption of fish or~          alcoholic beverages, smoking status were considered during statistical analyses.~   "
169827|NCT01342653|"~     Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric~     cancer. The goal is to get 1C level of evidence (patient died with standard treatment, with~     this treatment some of them survive) in terms of disease free survival and overall survival.~      Methodology: prospective, phase II, multicentric in Spain. Recruitment of 50 patients(to have~     31 on treatment) in three years. This strategy is based on neoadjuvant systemic plus~     simultaneous intraperitoneal and intravenous chemotherapy(NIPS),to treat peritoneal disease~     by bi-directional approach; next step is cytoreductive surgery and HIPEC. Once patients are~     discharged, they will follow a systemic adjuvant chemotherapy protocol.~   "
169828|NCT01342640|"~     This single arm, open label, multicenter study will evaluate the safety and change in~     hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients~     with chronic renal anemia who are not on dialysis. Patients will receive as a recommended~     starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is~     dependent on the patient's weight. Dose adjustment may be required due to inadequate or~     excessive treatment response. The anticipated time on study treatment is 28 weeks.~   "
169829|NCT01342627|"~     Study Design This is a multicenter, open label, first line phase II study in elderly (≥ 65~     years old) metastatic Renal Cell Carcinoma (mRCC) patients not suitable for any other~     currently approved treatment (bevacizumab+INF, cytokines or sunitinib) except for sorafenib.~      Each patient treated with sorafenib enrolled in the study will be trained to observe the~     management tool for skin care. A study period of 3 years was estimated as follows: an~     enrollment period of 24 months and a further follow-up period of 12 months.~      Objectives of the trial Primary objective The primary aim of this trial is the evaluation of~     the efficacy of a patient education program in the reduction of Hand-Foot Skin Reaction~     (HFSR).~      Secondary Objectives~      TO assess:~        -  The frequency of dose discontinuation, interruption and reduction~        -  The incidence of any grade diarrhoea, and other adverse events~        -  The overall Response Rate according to the RECIST criteria.~        -  Progression free survival (PFR) in study population and comparison of PFS between age~          sub groups in the current study population~   "
169830|NCT01342614|"~     The objective of this study is to investigate the effect of metformin on the correlation~     between hyperinsulinemia and hypertension.~   "
169831|NCT01342601|"~     Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection~     against external agents like aeroallergens. The effects of Ectoin containing nasal spray and~     eye drops have already been demonstrated in several studies with adult Seasonal Allergic~     Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of~     allergic rhinitis without resulting in any significant adverse events.~      The aim of this clinical investigation is to demonstrate the safety, tolerability and~     efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR patients.~     It is assumed that Ectoin containing products show an excellent safety profile and very good~     tolerability together with a potent efficacy in the treatment of SAR.~   "
169832|NCT01342588|"~     The purpose of this study is to establish the accuracy of pedicle positioning using~     continuous electrical pulse during screwing. Additionally, the investigators evaluate if this~     maneuver can prevent neurological injury during track creation and screwing in lumbar and~     thoracic spine instrumentation surgery~   "
169833|NCT01342575|"~     The purpose of this study is to establish which of five different maneuvers could bring the~     best trans-operatory x-ray exposure during anterior cervical surgeries with the higher~     security~   "
169846|NCT01342406|"~     This study will compare aqueous humor dynamics in adults with primary open angle glaucoma~     that receive Selective Laser Trabeculoplasty (SLT).~   "
169847|NCT01342393|"~     Proof of concept study is to compare the best corrected visual acuity obtained via~     First-Sight lenses with the clinical gold standard of manifest refraction and~     autorefraction.~   "
169848|NCT01342380|"~     Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing~     pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted~     at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic syndrome~     comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB # 07-07-20).~     Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with bipolar~     depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer to the~     respective IRB protocols for more information.~   "
169834|NCT01342562|"~     Spinal block is the most common anesthetic technique for transurethral resection of~     prostatectomy (TURP). Most patients undergoing TURP are elderly and frequently present with~     cardiopulmonary and endocrine diseases. Low-dose local anesthetic is commonly administer to~     limit the block level to minimize the hemodynamic changes. However, sometimes it may not~     provide an adequate level of sensory block. Thus, intrathecal additive is frequently~     administer with local anesthetic to improve analgesic effect.~      Dexmedetomidine(DXM), a selective 2-adrenoreceptor agonist, has been used in the epidural~     space in humans without any reports of neurological deficits. Previous clinical studies~     showed that intravenous dexmedetomidine administration prolonged the sensory and motor blocks~     of bupivacaine spinal analgesia. But clinical studies about the use of intrathecal DXM with~     local anesthesia in humans are scarce in the literature. Kanazi et al. found that 3μg DXM~     added to 12 mg spinal bupivacaine produced the significant short onset of sensory and motor~     block as well as significantly longer duration of sensory and motor block than bupivacaine.~     And Al-Mustafa et al. reported that intrathecal dexmedetomidine as an adjuvant to 12.5mg~     bupivacaine in spinal anesthesia has a dose dependant effect on the onset and regression of~     sensory and motor block.~      In our previous study, low-dose diluted bupivacaine 5 mg provided sufficient anesthetic level~     when opioid was added with local anesthetic. However, opioid-induced side effects, such as~     pruritus, nausea, or vomiting, could be an obstacle in common use. The aim of this study is~     to evaluate whether DXM-low-dose bupivacaine spinal anesthesia can provide the effective~     spinal anesthesia and postoperative analgesia with minimal side effect compare to the local~     anesthetic only group.~      This study was conducted in a randomized, double-blind, controlled fashion. Patients were~     randomly allocated to DXM group or Saline group. DMT group received hyperbaric bupivacaine~     0.5% (1.2 ml) (6 mg) in dextrose 8% solution + DMT 0.3 ml (3 µg)－in total, bupivacaine 0.4%~     (1.5 ml) intrathecally and Saline group received hyperbaric bupivacaine 0.5% (1.2 ml) (6 mg)~     in dextrose 8% solution + normal saline 0.3 ml －in total, bupivacaine 0.4% (1.5 ml)~     intrathecally. After spinal block, the level of sensory block, defined as the dermatomal~     segment with loss of pain sensation to pin-prick with a 22 G hypodermic needle and cold~     sensation to alcohol swab was measured every 2 min after intrathecal injection. The~     investigators recorded the peak sensory block level, time to peak block level from~     intrathecal injection, blood pressure and heart rate, and analgesic supplementation during~     operation. The maximum motor block level was assessed according to the modified Bromage~     scale. During postoperative period, the frequency of analgesic requirement, time to the first~     analgesic request, and pain scores were evaluated by blind investigator.~   "
169835|NCT01342549|"~     The purpose of this research study is to understand the effectiveness of valproate (a common~     mood stabilizer) to further reduce alcohol misuse when given in addition to attending an~     alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main~     goal of this project is to understand if people receiving valproate will have a better~     recovery than people receiving the standard treatment for alcohol dependence: naltrexone.~   "
169836|NCT01342536|"~     Primary Aim 1: Examine effectiveness of the Oh Happy Day Class (OHDC) compared to the Coping~     With Depression (CWD)in increasing retention, adherence, engagement, satisfaction, and~     treatment-seeking. The investigators hypothesize the OHDC compared to the CWD will result in~     greater increases in: 1a. retention, 1b. adherence, 1c. engagement, and 1d. satisfaction at~     the middle and end of the intervention, and 2.e. greater increase in treatment-seeking 3-,~     6-, 9-, and 12- months post-intervention. Outcome measures: logs: attendance, homework~     completion, class-participation level; Client Satisfaction Inventory; and Cornell Service~     Index. Primary Aim 2: Examine effectiveness of the OHDC in reducing symptoms of depression at~     the middle and immediate end of the intervention, and 3-, 6-, 9-, and 12- months~     post-intervention. The investigators hypothesize the OHDC will result in greater reduction in~     depressive symptoms compared to the CWD at 3-months post-intervention. Outcome measures:~     Center for Epidemiologic Studies Depression Scale and Quick Inventory of Depression Symptoms.~     Secondary Aim 3: Examine the effectiveness of the OHDC in improving self-reports of mental~     and physical health status and reducing self-reports of perceived disability. The~     investigators hypothesize the OHDC compared to the CWD will result in greater self-report of:~     3a. improved mental and physical health status, and 3b. reduced self-report of disability at~     the immediate end of the intervention and 3-,6-, 9-, 12- months post-intervention. Outcome~     measures: SF-12 Health Survey, and World Health Organization Disability Assessment Schedule.~      Public Health Impact: Based on CAI research, the OHDC has the potential to be four times more~     effective than the CWD. If our hypotheses are proven, the OHDC will be the first~     evidence-based culturally adapted depression intervention designed specifically for African~     American men and women between the ages of 30-60.~   "
169837|NCT01342523|"~     This is an evaluative study of three National Cancer Institute (NCI) smoking cessation~     resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS~     counseling phone calls. The following are the identified critical questions: (1). How~     effective is each of the tobacco interventions (websites [smokefree.gov & women~     smokefree.gov], NCI's Cessation Quitline counseling services operated by the Cancer~     Information Service (CIS) (2). How do they compare with alternative intervention strategies?~     (3). Which types of interventions appear to work best together (due to additive or~     interactive effects)? (4). How do these interventions work? (5). How much are these~     interventions used, and what are their relative use rates? (6). Are there important~     differences in effectiveness or use rates as a function of gender, SES, or other important~     person factors? We believe that the research study will address all of these questions, as~     well as some less central ones.~   "
169838|NCT01342510|"~     Since the introduction of propofol into routine anesthesia practice, the phenomena of pain on~     injection has plagued anesthesia providers. Propofol, an unstable phenol, triggers the~     release of bradykinin on injection. This release causes a painful burning sensation in the~     patient at the site of injection. Anesthesia providers have attempted a large number of~     remedies to prevent this pain on injection. Previously explored ideas include injecting~     propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment~     with numerous other medications. Currently, pretreatment with lidocaine is commonly~     administered to prevent propofol injection pain. No studies to date have looked at the~     combination of lidocaine and magnesium in a single syringe for the pretreatment of pain on~     injection caused by propofol. In addition, the administration protocols that have been~     studied thus far do not mirror clinical practice at the University of Wisconsin. The~     investigators propose studying the use of magnesium and lidocaine in a single syringe for~     pretreatment of propofol related pain on injection.~   "
169839|NCT01342497|"~     The aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on the~     healing of complicated diabetic foot ulcers.~   "
169840|NCT01342484|"~     The main objective of this study is to identify the dose of linagliptin in paediatric~     patients.~      Other efficacy objectives include the comparison of the lowering effect of linagliptin low~     dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of~     treatment.~      Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD)~     and the PK/PD relationship of linagliptin in the paediatric population.~   "
169841|NCT01342471|"~     Physical inactivity is a major public health problem and a primary contributing factor to the~     obesity epidemic. While most Americans do not meet the physical activity (PA) guidelines (30~     min/day, 5 day/wk), they do report watching several hours of TV each day, and frequently site~     lack of time as a barrier for engaging in PA. The Physical Activity and Leisure-time Study~     examines an approach convert sedentary TV watching into active TV watching time by having~     adults step in place during commercials (TV commercial stepping).~   "
169842|NCT01342458|"~     The purpose of this study is to determine whether inexpensive, flexible and non-heeled~     footwear is effective in improving of clinical, functional and gait biomechanics in elderly~     women with knee osteoarthritis.~   "
169849|NCT01342367|"~     The purpose of this study is see if quality of life is improved in patients receiving oral~     hormone therapy compared to standard of care. The study will also compare survival rates~     between patients receiving oral hormone therapy and those receiving standard of care.~   "
169851|NCT01342341|"~     The overall goals of this study are to (1) expand knowledge about interactions of~     chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in~     moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on~     visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.~   "
169852|NCT01342328|"~     Cognitive dysfunction, either alone or as an element in the syndrome of delirium, is a common~     occurrence with an incidence as high as 75% in intensive care unit (ICU) patients and can~     independently result in serious consequences including higher mortality rate. Delirium~     develops through a complex interaction between the patient's baseline vulnerability (risk~     factors) and precipitating factors such as disruption of sleep that may occur during~     hospitalization. While sedative-hypnotic agents that are used to facilitate hypnosis and the~     management of mechanically ventilated patients converge on the neural substrate that mediate~     endogenous sleep, they do so at different juncture points depending on its molecular~     mechanism of hypnotic action. Hypnotic agents that modulate the GABAA receptor converge at~     the level of the hypothalamus while α2 adrenergic agonists converge on sleep pathways within~     the brainstem. This translational project seeks to determine whether sedation mediated by~     activation of α2 adrenoceptors (dexmedetomidine) is more like natural sleep than that~     provided by a sedative agent that modulates the GABAA receptor (propofol). The investigators~     will examine volunteers who will be monitored continuously by electroencephalography (EEG)~     and whole-brain functional connectivity by magnetoencephalography (MEG) during each of three~     sleep stages, namely, that induced by dexmedetomidine, propofol, or saline (natural sleep,~     control). The two drug-induced sleep regimens will be compared to natural sleep using EEG and~     brain connectivity by MEG~   "
169853|NCT01342315|"~     To determine if a topical antifungal cream is safe and effective for the treatment of tinea~     cruris~   "
169854|NCT01342302|"~     Breast cancer is distressing for couples in general but even more so when the illness strikes~     at a relatively young age. In addition to common relationship challenges, younger couples~     have to contend with the loss or disruption of age-appropriate goals for themselves.~     Presently, there are virtually no resources designed specifically to assist young couples~     coping with breast cancer. The purpose of this study is to develop and evaluate an online~     educational program geared to the unique needs and demanding schedules of young couples. The~     purpose of the program is to improve couples' relationships and mutual coping. Seventeen~     couples will take part in the 7-week program. They will complete questionnaires before and~     after participating to evaluate the program's helpfulness. This study will allow for the~     creation of a user-friendly, cost-effective tool that could help to improve the lives of all~     young couples coping with breast cancer in the years to come.~   "
169855|NCT01342289|"~     This research is being done to learn more about nonmyeloablative bone marrow transplantation~     (BMT), also known as a mini transplant for patients with blood cancers, using bone marrow~     from a relative.~   "
169856|NCT01342276|"~     Several studies have indicated that heart failure (HF) clinics facilitating patient~     self-management and using multi-disciplinary care reduce in hospital bed-days, all-cause and~     HF-related hospitalizations, all-cause mortality, and improve patient quality of life.~     Additionally, national and provincial organizations have identified patient-focused homecare~     initiatives in telehealth as demonstrating great promise for health service. Our pilot study~     demonstrated the feasibility of the internet based vHFC and supports the investigation of~     this intervention in patients with HF.~      The purpose of our single-blinded randomized trail is to investigate the efficacy of an~     Internet-based heart failure (HF) clinic (vHFC) in 186 patients living with HF.~      Hypotheses~      A. Participation in a vHFC emphasizing patient self-management and monitoring will result in~     improved functional capacity compared to usual care in patients with HF.~      B. Participation in a vHFC emphasizing patient self-management and monitoring will result in~     improved health indices such as, self-management skills, quality of life, levels of B-type~     natriuretic peptide and healthcare utilization compared to usual care in patients with HF.~      Our objectives of the vHFC study is as follows:~        1. To establish a cohort of 186 patients with HF.~        2. To determine the benefits of participating in the vHFC over usual care at 12 months with~          respect to exercise capacity.~        3. To compare the changes in other risk factors and lifestyle behaviours between the vHFC~          and usual care patients.~   "
169857|NCT01342263|"~     In 2005, more then one-third of Canadians were burdened with one or more chronic diseases.~     Patients with one chronic disease often have, or are at risk for, another chronic disease.~     This group of complex patients represents a substantial challenge to healthcare resources.~     For patients in rural communities, the opportunity to attend ambulatory care clinics is not~     always an option. Additionally, the opportunity for rural patients to receive quality care~     close to, or within their homes, is of great benefit as it reduces the need for extensive~     travel and the potential burden of clinical visits. The use of telehealth has been identified~     as an effective modality for chronic disease management and is actively promoted by national~     organizations as having great promise for health service delivery in rural areas. The~     Internet as a mode for healthcare delivery has numerous advantages: 1. it is ubiquitous with~     increasing access in all age groups, 2. it is inexpensive, 3. it facilitates both patient~     data transfer and patient feedback, thereby supporting patient self-management, 4. it is~     scalable to large patient volumes, 5. it delivers health care directly to the patient and 6.~     it requires minimal set-up for patients with current Internet access.~      The investigators propose to develop and evaluate a multi-chronic disease management program~     delivered through the Internet (with telephone supports) focused on high-impact chronic~     diseases targeted to patients in rural communities.~      This study will consist of a single-blinded randomized controlled trial to investigate the~     efficacy of the iCDM in 318 patients with two or more of the target chronic diseases living~     in rural areas. Within this Aim, the investigators will be able to address the following~     research questions:~      Q1. What is the effect of iCDM on healthcare utilization and patient self-management~     outcomes? Q2. What is the long-term compliance to the iCDM? Q3. What is the level of patient~     and provider satisfaction?~   "
169858|NCT01342250|"~     Although liver transplantation provide a option to cure patients suffering with decompensated~     liver cirrhosis this condition, lack of donors, postoperative complications, especially~     rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells~     (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued~     experimental liver failure and contributed to liver regeneration, which suggest the novel and~     promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord~     mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver~     cirrhosis will be evaluated.~   "
169859|NCT01342237|"~     The investigators plan to improve event free survival rate and reduce treatment related~     toxicities of pediatric patients with high risk/recurrent CNS tumors by administrating tandem~     high dose chemotherapy and autologous stem cell rescue.~   "
169862|NCT01342198|"~     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a~     pregabalin controlled release tablet with and without coadministration of erythromycin and 2)~     evaluate the safety and tolerability of a single dose of a pregabalin controlled release~     tablet with and without coadministration of erythromycin.~   "
169863|NCT01342185|"~     The purpose of this study is to verify the effectiveness and safety of medical ozone therapy~     system in treatment of chronic hepatitis B.~   "
169864|NCT01342172|"~     The primary objectives of this study are (Phase 1) to determine in subjects with unresectable~     or metastatic bladder cancer who have never had chemotherapy, the dose of lenalidomide that~     is well-tolerated when given in combination with gemcitabine plus cisplatin and (Phase 2) to~     study this recommended dose in subjects to evaluate progression-free survival at 1 year. The~     secondary objectives will be to determine the objective response rate to treatment, and the~     safety of combination therapy with gemcitabine, cisplatin and lenalidomide as well as to~     evaluate lenalidomide as maintenance treatment in subjects achieving objective response or~     stable disease.~   "
169865|NCT01342159|"~     One of the most frequent complications of diabetic retinopathy is diabetic macular edema.~     Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular~     therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and~     intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it~     was the purpose of the present study to compare these treatment effects~   "
169866|NCT01342146|"~     The purpose of the multicenter, randomized, open-label, controlled phase II study is to~     determine whether pegylated recombinant human growth hormone is effective in the treatment of~     children with growth hormone deficiency.~   "
169867|NCT01342133|"~     The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn~     infants using a non-invasive confocal microscopy device.~   "
169868|NCT01342120|"~     The purpose of this observational study is to study specific outcomes of interest in users of~     quetiapine compared with all other atypical antipsychotics and specifically olanzapine and~     risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts,~     extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and~     stroke. This retrospective cohort study is based on population-based record linkage system~     (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.~   "
169869|NCT01342107|"~     The purpose of this study is to evaluate lens wettability of contact lenses when used with an~     investigational multi-purpose disinfecting solution.~   "
169870|NCT01342094|"~     DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol~     ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary~     open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized,~     double-masked, parallel-group comparison study. Safety will be compared and evaluated as~     well.~   "
169871|NCT01342081|"~     DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost~     0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and~     Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering~     effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter,~     randomized, double-masked, parallel-group comparison study. Safety will be compared and~     evaluated as well.~   "
169872|NCT01342068|"~     Thoracic Outlet Syndrome (TOS) is a condition causing numbness, tingling and weakness in~     patient's upper limbs. Symptoms are due to compression and restriction of the nerves and~     blood vessels (neurovascular bundle) that extend from the neck into the upper limb exerted by~     a patient's various anatomical structures. Neurovascular bundle compression can result in~     decreased nerve conduction and blood flow through the arteries supplying structures~     downstream from the restricted site. These anatomical restrictions include tight scalene~     muscles in the neck, tightened pectorialis minor muscle in the chest and extra ribs growing~     from the C7 vertebra.~      TOS can be diagnosed by using special tests designed to re-elicit neurovascular bundle~     compression. Upon obtaining a positive test, the patient can undergo osteopathic manipulative~     treatments (OMT) to change the anatomical restrictions allowing for a decrease of symptoms~     and even eradication of the syndrome altogether.~      Although diagnosis and treatment of TOS is common in osteopathic medicine, the effectiveness~     of the diagnostic special tests and treatment has not been thoroughly investigated. This~     study aims to examine the effectiveness of the special tests (Adson's, Wright's~     hyperabduction and Halstead maneuver) in diagnosing a change in blood flow through the~     arteries of the upper arm compared to evaluation with Doppler ultrasound to measure blood~     flow while the tests are performed. Patients with positive tests will be treated with OMT~     including myofascial release, soft tissue, and articulation to relieve restricting~     structures. Upon completion of treatment, the special tests will be performed again along~     with the Doppler ultrasound to measure blood flow through blood vessels. Results then are~     analyzed statistically for significance of the ability correctly diagnose and treat TOS~     symptoms.~      Results from this study will contribute towards the validity of teaching special tests in~     osteopathic medical schools and allow for a non-invasive treatment protocol for patients with~     TOS.~   "
169873|NCT01342055|"~     A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and~     Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.~   "
169874|NCT01342042|"~     This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes~     Mellitus will take part in the trial.~      Subjects will randomly enter into one of three groups, administration daily twice, the period~     of is 84 days treatment. Subjects should be in hospital for pharmacokinetic studies in 1 d~~     8d, 30 d (if necessary)and 84 d, during 9 d ~ 83 d outpatient follow-up.~   "
169875|NCT01342029|"~     This research study is designed to test the use of ranolazine in patients with angina (chest~     discomfort due to reduced blood supply to the heart) due to microvascular coronary~     dysfunction (MCD; abnormalities in the small blood vessels of the heart). This drug is~     approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina. The~     FDA has approved this drug based on studies primarily on patients with chronic angina with~     major blockages of the arteries.~   "
169876|NCT01342016|"~     The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with~     leflunomide tablets in the treatment of lupus nephritis.~   "
169877|NCT01342003|"~     Sustained virological response (SVR) to antiviral therapy in patients with chronic hepatitis~     C genotype 1 according to subtype (1a vs.1b) has not been extensively investigated. This~     observational study was carried out on a large group of naïve HCV patients to evaluate~     difference, if any, between HCV genotype 1 subtype 1a and 1b on the response to treatment~     with peginterferon (Peg-IFN) plus ribavirin.~   "
169878|NCT01341990|"~     The purpose of the study is to evaluate the effect of an investigational multi-purpose~     disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of~     silicone hydrogel contact lenses.~   "
169880|NCT01341964|"~     Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to~     prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky~     cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen~     to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with~     aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients~     with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.~   "
169881|NCT01341951|"~     Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis~   "
169882|NCT01341938|"~     This research study will determine if using a combination of 4-mg nicotine lozenges,~     self-help materials, and/or telephone tobacco cessation counseling will help smokeless~     tobacco users stop using tobacco. The study will consist of three interventions:~        1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy,~          phone counseling, and self help materials~        2. Assisted Self-Help intervention - self-help materials and phone counseling without~          lozenges~        3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement~          therapy.~      Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the~     prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at~     6 months among ST users who are interested in achieving tobacco abstinence, compared to those~     in the Assisted Self-Help intervention and the Lozenge Self Help intervention.~   "
169883|NCT01341925|"~     Childhood depression warrants treatment research; including pharmacological and~     psychotherapeutic interventions. A recent study found fluoxetine to be the only medication~     with empirical support for decreasing depression in children, but concerns about~     treatment-emergent suicidal ideation/behavior led the FDA to mandate black-box warning for~     use of antidepressants in this age group (Bridge et al, 2007). These worries have prompted~     interest in alternative therapies including dietary supplements such as omega-3 fatty acids~     (Ω3).~      The current study compares Ω3, psychoeducational psychotherapy (PEP), and their combination~     to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with~     unipolar depression. Primary goals are to determine: 1) feasibility of a) recruiting 60~     participants in 24 months; b) retaining participants over a 12-week trial; and 2) effect~     sizes for Ω3, PEP, and combination treatment. Secondary goals are to explore response curves~     over time, mediators and moderators, treatment response across an array of outcome variables,~     adherence to treatment, and side effects. This pilot study of Ω3, PEP, and combined treatment~     will provide evidence about whether a larger trial is feasible and justifiable.~   "
169884|NCT01341912|"~     The purpose of the study is to study the long-term efficacy, safety and tolerability of~     Human-cl rhFVIII in previously treated patients with severe hemophilia A.~   "
169885|NCT01341899|"~     Type 1 diabetes is an autoimmune disease and results from T cell autoimmunity mediated~     destruction of the majority of insulin-producing pancreatic β-cells. Hence,the development of~     new therapies to control T cell autoimmunity, and to preserve the remaining β-cell function~     will be of great significance in managing patients with type 1 diabetes~      Autologous nonmyeloablative hematopoietic stem cell transplantation (AHST) has been tested~     for the treatment of patients with new onset of type 1 diabetes. This therapeutic strategy~     can result in exogenous insulin independence by destroying pathogenic memory T cells and~     preserving the remaining β-cell function.~      However, little is known about the efficacy of AHST in the dynamics of immunocompetent cell~     reconstitution and how the reconstituted immune system regulates β-cell specific antibody~     response. Furthermore, many Chinese patients at diagnosis of type 1 diabetes have progressed~     to develop diabetic ketoacidosis (DKA). Whether treatment with AHST could still achieve~     adequate glycemic control and preserve the β-cell function and what the factors are~     associated with the therapeutic efficacy have not been explored.~      This is a phase Ⅱ clinical trial in patients who have been diagnosed with type 1 diabetes~     within the previous 12 months.This study is to determine:~        -  The effects of autologous hematopoietic stem cell transplantation on the reconstitution~          of immune system~        -  β-cell preservation following stem cell transplantation~        -  The potential factors affecting efficacy of stem cell transplantation~        -  Whether this new therapy is safe.~   "
169886|NCT01341886|"~     Differentiated thyroid cancer is the most common neoplasm of endocrine system. After surgery~     and radioiodine treatment, thyroid stimulating hormone (TSH) suppression is the main goal~     which is achieved with levothyroxine treatment. Levothyroxine causes increased thyroid~     hormones which can have negative impact on bone and cardiovascular system. Anecdotal reports~     have shown that metformin can induce TSH suppression without change in T3 and T4~     concentration. The purpose of this study was to prescribe metformin as additional drug to~     levothyroxin in order to decrease levothyroxine dosage.~   "
169887|NCT01341873|"~     This randomized clinical trial studies nursing intervention in supporting family caregivers~     (FCs) of patients undergoing stem cell transplant. A nursing intervention may help prepare~     FCs support the recovery of the patients~   "
169888|NCT01341860|"~     A single-nucleotide polymorphism (SNP) analysis of DNA obtained from peripheral blood of the~     obese patients and the normal control will be performed to find genetic marker for obesity~   "
169889|NCT01341847|"~     Aim of the Study :~      This study will compare the colonoscopy examination between the air method (air insufflation)~     and water method (water infusion) in unsedated patients with indication (symptoms and signs~     based) of colonoscopy examination. This study is based on earlier study which showed that~     water method had better results in reducing abdominal pain, caecal intubation and patients~     willingness to repeat colonoscopy examination than air method.~      Background:~      Colonoscopy examination is an important method to examine and establish the diagnosis of~     various diseases in the colon. Colonoscopy is successful when the tip of the scope reach the~     cecum and observe the caecal valve and/ or appendix orifice. This examination can be~     performed unsedated or under sedation (conscious sedation or deep sedation/general~     anaesthesia). The main disadvantage of unsedated colonoscopy method is the abdominal~     discomfort or pain during examination that may make patient distress and hemodynamically~     unstable and possibly stoppage of the examination before reach the cecum, but the severity of~     abdominal symptoms is vary from patient to patient. Many efforts have been tried to reduce~     the abdominal discomfort during examination. This unsedated method with air insufflation is~     our hospital standard method for colonoscopy examination since early 1980s, and less than 1%~     of patients were colonoscopied with conscious or deep sedation. Our study showed the success~     rate of this standard unsedated method was about 82%. The advantage of this method is~     inexpensive (feasible for most of people in developing country like us), patient may be~     examined ambulatory without escort, may back to work as soon as the examination is finished.~     Studies showed that replace the air insufflation with water infusion into colon since the~     beginning of the examination increased the success rate of caecal intubation and reduced the~     abdominal pain symptoms during colonoscopy examination(1). Sedation or general anaesthesia~     may increase the success rate of colonoscopy examination but it is costly, and may increase~     the adverse event especially in the elderly or patients with significance cardiopulmonary~     problems.~      Research Design and Methods:~      Eligible patients in the hospital clinics or wards will be offered to follow unsedated~     colonoscopy examination. The principle investigator (PI) will explain the study, the~     colonoscopy procedure , the various symptoms that may be felt during examination, the~     possible adverse event and medical effort to prevent it. Patient who sign the informed~     consent will be included in the study.~      Methods on the day of exam. Enrolled patients will be sent to the endoscopy room and~     colonoscopy will be performed by the principle investigator. Patient lie on the left lateral~     position with right hip and knee flexed and left leg straight. When the PI about to start the~     single-handed colonoscopy examination, the blinded observer open the sealed envelops with the~     code enclosed. A standard colonoscope will be inserted. Patient may be ordered to change the~     position and or abdominal compression may be applied by nurse to aid the colonoscope~     advancement. Oximetry, cardiac rhythm and blood pressure will be monitored during~     examination. Blinding will not be performed in this study because of the feeling of water or~     air effect inside the colon can be differentiated by the patient so that in our opinion it~     actually can not be blinded..The control method includes usual air insufflation during~     insertion and shortening maneuvers. The study method includes only water infusion (air pump~     is turned off) through the colonoscope during insertion since the scope is inserted into the~     anus until reach the cecum. Water will be infused as needed under endoscopist judgement~     through the adaptor on biopsy channel with endoscopic washer pump. The usual air insufflation~     will be used during colonoscope withdrawal to facilitate mucosal examination and perform any~     other intervention, such as biopsy. Hypothesis testing: The unsedated colonoscopy with~     natural temperature water infusion minimize the pain symptoms than unsedated colonoscopy with~     usual air insufflation.~   "
169890|NCT01341834|"~     The purpose of this study is:~        1. To determine the optimal recommended phase II dose of two investigational study drugs,~          LBH589 and RAD001, given in combination in all solid tumors (With enrichment for~          EBV-Driven tumors).~        2. To determine the pharmacokinetic profile of RAD001 in combination with two schedules of~          LBH589.~        3. To assess the preliminary anti-tumor activity of RAD001 and LBH589.~      This study will also be exploring the hypothesis that HDACi and mTOR inhibitors abrogate the~     effects of key viral proteins, and switch the virus from a latent proliferative phase to a~     lytic phase. Immunologic correlates will also be examined to ascertain T-cell subpopulations~     and expression of HLA class molecules. DCE-MRI will be subsequently employed in dose~     expansion to examine antiangiogenic effects.~   "
169949|NCT01341067|"~     The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on~     subjects with type 2 diabetes. It is anticipated that patients using the device will obtain~     tighter control of their blood sugars resulting in measureable health benefits and improved~     confidence in their ability to manage their diabetes.~   "
169891|NCT01341821|"~     This study is to discuss how different personalities of leaders and employees result in the~     effect of quality and efficiency in different organizational climate and also how the~     leadership style of different leaders affect the organizational climate. The investigators~     hope that this study will improve the key factor of quality and efficiency among leaders.~     Besides, the investigators want to provide the reference of quality control for the groups of~     healthcare quality in order to avoid unnecessary time and costs and achieve the goal of~     improvement quality.~   "
169892|NCT01341808|"~     The purpose of this study is to measure the immune response in 18-40 year old IBD patients~     after receiving the hepatitis A vaccine.~   "
169893|NCT01341795|"~     Type 2 diabetes have become a major global health problem. Currently, metformin is used as~     first-line therapy in combination with lifestyle changes, and sitagliptin can be added to~     metformin in case of insufficient glycemic control by metformin alone, and fixed-dose~     combination of sitagliptin and metformin is available.~      In clinical practice, inter-individual variations in response to sitagliptin and metformin~     treatment are commonly found, which may reflect inter-patient differences in disposition of~     these medications.~      Sitagliptin and metformin are known as substrates of some transporters (P-gp, OAT3, OCT1 and~     OCT2) and some functional variations of these transporters were reported. This study is~     designed to clarify the effect of these transporter variants on response to sitagliptin and~     metformin in type 2 DM patients.~   "
169894|NCT01341782|"~     This study is a comparison of the efficacy and safety of paricalcitol injection with~     maxacalcitol injection in adult Japanese chronic kidney disease patients receiving~     hemodialysis with secondary hyperparathyroidism. The main objective of this study is to~     demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone~     without clinically significant hypercalcemia, compared to maxacalcitol injection.~   "
169895|NCT01341769|"~     The purpose of this study is to assess the effects of added food ingredients, when baked into~     a snack food product, on glycaemic index of the product and glycaemic and insulinemic~     responses to the product in healthy adults.~   "
169896|NCT01341756|"~     The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which~     equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to~     historical controls.~   "
169897|NCT01341743|"~     The purpose of this study is to evaluate the efficacy and safety of generic entecavir~     monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate~     response to NUC therapy~   "
169898|NCT01341730|"~     This study is a prospective randomized clinical trial and to compare the antiinflammatory~     effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy~     in carotid arteries of stable and unstable angina patients by PET/CT.~   "
169899|NCT01341717|"~     The purpose of the study is to determine the efficacy and safety of sitaglipin in the~     treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using~     metformin and insulin.~   "
169900|NCT01341704|"~     Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective~     efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease~     occurring during a period beginning from 14 days after the 3rd immunization until 1 year~     after.~      The primary objective of this double-blind, randomized, controlled trial will be to assess~     the clinical efficacy of MSP3-LSP/AlOH vaccine when administered by subcutaneous route in~     children aged 12-48 months against all clinical malaria episodes occurring during a period~     beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization, when~     administered according to the following schedule:- Primary administration: Three doses of~     administered 4 weeks apart~      Secondary administration (Boost): One dose 3 months after the third dose in year 1 of the~     trial; and two doses, given exactly one year after the date corresponding to the third dose~     and the first boost given during Year 1~      Case definition for an episode of malaria is a febrile illness with axillary temperature of ≥~     37.5ºC with P. falciparum parasitemia ≥ 5000 per μL~   "
169901|NCT01341691|"~     To determine the amount of phosphate recovered into 2 strengths of K2CG chewing gum in a~     modified formulation (with or without an extender) added to the gum core, in comparison to~     matching placebo gums.~   "
169902|NCT01341678|"~     The purpose of this study is to describe the circadian rhythm of serum and salivary~     phosphorus in patients with chronic kidney disease and determine its' modification in~     response to changes in dietary phosphate load.~   "
169903|NCT01341665|"~     The aim of this study is to evaluate the different types of osmotic dysregulation in patients~     with Syndrome of Inappropriate ADH (SIADH) and, hence, to analyze the pathophysiology of~     SIADH.~      These types will be characterized by measurement of AVP and copeptin while performing an~     osmotic stimulation with infusion of hypertonic saline.~   "
169904|NCT01341652|"~     The investigators are trying to find new methods to treat prostate cancer. The approach the~     investigators are taking is to try to enhance patients' own immune response against the~     cancer. In this study the investigators will be testing the effectiveness of a vaccine that~     may be able to help the body fight prostate cancer.~   "
169905|NCT01341639|"~     This study will determine whether subjects who receive V419 at 2, 3, 4, and 12 months of age~     have an acceptable immune response to the vaccine. The study will also determine whether the~     immune response to V419 is similar to that of subjects who receive a licensed vaccine~     control.~   "
169906|NCT01341626|"~     This study is a young adult follow-up of 166 females who originally participated in an RCT~     during adolescence due to their involvement in the juvenile justice system.~   "
169907|NCT01341613|"~     Background: It is becoming increasingly clear that individuals from all corners of the globe~     use probiotic dietary approaches to enhance health. More recently, probiotics have shown~     promise in treating a variety of disease states, due to improved strain selection, stability~     and delivery technologies.~      Objective: The purpose of this study is to determine the lipid lowering efficacy of a~     probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per~     day over 9 weeks, in subjects with hypercholesterolemia.~      Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm,~     multi-centre study. The study will last a total of 13 weeks, including a 2-week wash-out~     period, a 2-week run-in period and a 9 week treatment period.~   "
169908|NCT01341600|"~     Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and~     conditions caused by blood clots. Although clopidogrel works in many individuals, some people~     do not respond as well to this drug. The variation in treatment response may be linked to~     genetics. This study will examine the effects of clopidogrel in a population in which~     sequencing for certain genes has been performed in order to determine the role that genes~     play in the response to various clopidogrel maintenance doses.~   "
169909|NCT01341587|"~     Currently, in the U.S., 1 in 3 males and 2 in 5 females born after 2000 are expected to~     develop diabetes during his or her lifetime. Research has demonstrated that control of blood~     glucose (BG) reduces the complications of diabetes. As a result, almost half of Americans~     diagnosed with diabetes, are prescribed finger-stick glucose meters to monitor their BG. The~     value of this approach is known to be limited by a high rate of patient non-compliance with~     BG testing, where patients test less often than prescribed. Increased communication between~     patient and care manager along with feedback has been shown to increase self monitoring of~     blood glucose (SMBG) test compliance. However, this feedback loop is largely absent from the~     current, episodic model of patient / care manager interaction and not available in existing~     BG meters given to diabetic patients.~      In this study, we propose to pilot test a cellular-embedded glucose meter. This device can~     transmit glucose readings directly over a cellular network to a care management server and~     then the patient will receive feedback on the screen of the glucose meter.~   "
169910|NCT01341574|"~     'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by right-~     as well as left-sided brain lesions, but more often by right-sided lesions. Patients with~     this disorder neglect the contralesional side of space and/or their body. Their body axis is~     often shifted ipsilesionally. A specific disorder that can appear in neglect patients is~     'contraversive pushing': a postural deviation to the neglected side because the patient~     pushes himself away from the ipsi- to the contralesional side.~      One of the most promising neglect interventions is prism adaptation (PA): inducing an optical~     shift of the visual field by means of prism glasses. This results in a modulation of brain~     areas involved in neglect and in an improvement of the neglect symptoms and postural~     deviation.~      Research questions:~        1. Which period is best suited to maximize therapeutic effects? In this respect the effects~          of early and delayed PA will be compared, regarding neglect-, postural and cerebral~          measures.~        2. Which factors lead to a less favorable treatment outcome or to therapy resistance for~          PA?~        3. Will the impact of PA be larger if postural factors are taken into account in the prism~          therapy?~   "
169911|NCT01341561|"~     The purpose of the study is to examine the relevance of biochemical markers (specific~     pulmonary and cardiac markers and markers of endogenous stress) in the process of weaning in~     patients with artificial ventilation.~   "
169912|NCT01341548|"~     The purpose of this study is to evaluate the safety and efficacy of intranasally administered~     civamide nasal solution in the prevention of cluster headaches during an episodic cluster~     headache period.~   "
169913|NCT01341535|"~     The investigators hypothesize that treatment adaptation to biological and anatomical changes,~     occurring during treatment, can increase the chance of cure at minimized or equal~     radiation-induced toxicity in head and neck cancer patients. This trial compares standard~     intensity-modulated radiotherapy (IMRT), using only pre-treatment planning~     18F-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive~     18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or~     volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning~     18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.~   "
169914|NCT01341522|"~     Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance~     Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to~     be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI~     examinations. A previous study has shown that MRI is indicated in 17% of all patients with~     pacemakers within 12 months of device placement , which demonstrates the need of practical,~     safe approach for performing MRI on pacemaker patients. A new Reply MR-conditional pacing~     system is developed by Sorin Group for safe use in the MRI environment. The new pacing system~     is composed by the Reply pacemaker and the Filtrea bradycardia pacing leads. This study~     intends to demonstrate the safety and the efficacy in the MRI environment of the Sorin Group~     Reply MR-conditional pacing system.~   "
169915|NCT01341509|"~     The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The~     purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing~     the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon~     debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles~     with flexor hallucis longus (FHL) transfer and Achilles tendon debridement, excision~     calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL transfer.~   "
169916|NCT01341496|"~     Background:~      - A tumor cell vaccine is an experimental cancer treatment. Cancer cells are collected from a~     patient and then used to develop a vaccine. The vaccine will produce an immune system~     response to help destroy other cancer cells in the body. Researchers are studying ways to~     improve these tumor cell vaccines. One way is to add an adjuvant. An adjuvant is a substance~     that brings about a stronger immune system response. ISCOMATRIX is an adjuvant that has been~     used safely in other clinical studies. But it has not been studied with certain tumor cell~     vaccines. Researchers want to find out whether a tumor cell vaccine with ISCOMATRIX, given~     along with cancer drug treatment, is a safe and effective way to slow or prevent tumor growth~     after tumor removal surgery.~      Objectives:~      - To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and~     drug therapy after tumor removal surgery.~      Eligibility:~      - People at least 18 years of age who have had tumor cell vaccines developed from cells taken~     from surgically removed tumors.~      Design:~        -  Patients will be screened with a physical examination, medical history, blood and urine~          tests, and imaging studies.~        -  Patients will be treated with cyclophosphamide (once daily) and celecoxib (twice daily)~          for 7 days before the first vaccine dose.~        -  Patients will receive the tumor cell vaccine once a month for 6 months. They will~          continue to receive drug therapy throughout the vaccine treatment. Patients will be~          monitored with regular blood tests and imaging studies.~        -  After the first 6 months, patients who have an immune response to the vaccine will~          continue treatment with the vaccine and chemotherapy. They will also have regular blood~          tests and imaging studies. They will have this treatment for up to 24 months from the~          first vaccination or until they no longer have an immune response.~        -  Participants will have followup visits for up to 5 years after the first vaccination, or~          until the tumor returns.~   "
169917|NCT01341483|"~     The purpose of this study is to determine the proportion of men with known or suspected~     coronary artery disease (CAD) and/or peripheral arterial disease (PAD) that have angiographic~     identifiable erectile related artery (ERA) atherosclerotic disease defined as at least one~     ERA stenosis greater than or equal to 50% (per core lab Quantitative Vascular Analysis -~     QVA).~   "
169918|NCT01341470|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.~   "
169920|NCT01341444|"~     This study is being conducted to see how safe and effective the Prevena Incision Management~     System Prevena is when placed over a renal transplantation incision. Prevena provides~     negative pressure (suction) wound therapy. Prevena will be tested while applied during the~     time each subject is hospitalized and up to 5 days after the surgery. Prevena is a small~     portable negative pressure device which consists of a therapy unit that delivers negative~     pressure. It also includes a dressing system that is intended for use over closed incisions~     after surgery.~      The intent of this study is to evaluate Prevena versus the standard care that a doctor would~     use normally after a kidney transplant.~   "
169921|NCT01341431|"~     The purpose of this study is to evaluate the efficacy of repeated (monthly) injections of bee~     venom on motor symptoms of Parkinson's disease over a period of one year, also the potential~     effects of this treatment on disease progression compared to placebo (saline injections).~   "
169922|NCT01341418|"~     This study compares two techniques for the fixation of tibial fractures. The techniques are~     the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary~     nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels,~     2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the~     patello-femoral cartilage between patients who are randomized to receive tibial nail~     insertion through either a suprapatellar nail entry portal or a standard patellar tendon~     approach.~   "
169923|NCT01341405|"~     This is a double-blind, randomized, multicenter, phase 2b, noninferiority comparison of two~     active dose levels of CG100649 vs. a standard anti-arthritic dose of celecoxib (Celebrex).~   "
169924|NCT01341392|"~     The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501~     and amlodipine after oral administration in healthy male volunteers.~   "
169925|NCT01341379|"~     Hyperammonemia, which can cause brain damage, occurs in many different kinds of inborn errors~     of metabolism. The investigators propose to determine if short-term (3 day) treatment with~     N-carbamylglutamate can diminish hyperammonemia by enhancing ureagenesis in these patients.~     The investigators propose here a short-term (3 day) trial. If it succeeds, the investigators~     would consider more extensive long-term studies of the drug.~   "
169926|NCT01341366|"~     Background:~      Laparoscopic colorectal surgery has been shown by randomized trials to be associated with~     better short-term clinical outcomes when compared with open surgery. However, in a~     traditional perioperative care setting, the reduction in hospital stay following laparoscopic~     surgery in these trials was modest. Fast-track perioperative programs have been introduced in~     the West to optimize perioperative factors to reduce the physiological/psychological stress~     of open colorectal surgery. However, few studies have evaluated the impact of fast-track~     programs on the outcomes after laparoscopic colorectal surgery.~      Objective:~      To compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing~     laparoscopic surgery for colorectal cancer with a traditional vs. a fast-track~     perioperative program.~      Design:~      Prospective randomized trial.~      Subjects:~      One hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection~     of non-metastatic colonic and upper rectal cancer will be recruited.~      Interventions:~      Patients will be randomized to a traditional or a fast-track perioperative program.~      Outcome measures:~      Primary outcome: total postoperative hospital stay, including hospital stay of patients who~     are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters~     (including systemic cytokine response and cell-mediated immune function), morbidity and~     mortality, quality of life, and medical costs.~   "
169927|NCT01341353|"~     The mainstay of treatment for atrial fibrillation remains pharmacological;however,catheter~     ablation has increasingly been used over the last decades. The relative merits of each~     strategy have not been extensively studied. Our study was designed to determine if catheter~     ablation is a feasible option as first-line therapy for treating patients with symptomatic~     AF.~   "
169928|NCT01341340|"~     The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy~     of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with~     critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the~     tibial arteries.~   "
169929|NCT01341327|"~     The purpose of this study is to observe clinical courses for long-term in patients with~     unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary~     stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA stenosis~     in the real world daily practice.~   "
169930|NCT01341314|"~     Research has shown that early aggressive use of medicines may stop rheumatoid arthritis~     (RA)or slow its damage. The key to this is to find people with early symptoms which could be~     RA and have them get a diagnosis, treatment and follow-up.~      This study will recruit persons who've gone to the internet looking for information about~     their symptoms. After answering a screening survey, the person with possible symptoms will be~     linked to the study website for a more detailed symptom questionnaire.~      After completing that questionnaire the person will receive information about the second part~     of the study which includes an examination with a rheumatologist (arthritis doctor)and~     laboratory tests.~      Based on the joint examination and laboratory tests, the rheumatologist will tell the person~     the likelihood of having RA, and make recommendations and if needed a referral for care and~     treatment. Treatment is not a part of this study.~      This study will also compare the information on the subject's questionnaires to the doctor's~     joint examination and the laboratory tests with the hope of developing a simple inexpensive~     case finding questionnaire.~   "
169931|NCT01341301|"~     The purpose of this research study is to examine the survival of patients undergoing~     partially matched hematopoietic stem cell transplant (HSCT) on a new type of treatment~     approach, which has been developed specifically for patients who have evidence of their~     disease at the time of transplant. In this research study, a way of strengthening the~     response of the donor cells against the disease has been developed. Patients will undergo one~     additional day between the two steps of the transplant which may allow their donor's cells to~     fight the disease more effectively.~   "
169932|NCT01341288|"~     A robotic brachytherapy device will be used to assist physicians in performing seed~     implantation to the prostate. EUCLIDIAN is the first robotic system designed to allow~     automatic placement of radioactive seeds by robot and thus reduce operator dependence. The~     clinical study is designed to evaluate the dosimetric quality, accuracy and patient~     self-reported quality of life scores after robotic brachytherapy.~   "
169933|NCT01341275|"~     The aims of this study are to determine:~        1. the degree of immunity against hepatitis B,~        2. factors associated with immunity against hepatitis B,~        3. if the amount of antigen provided in a booster dose (used to measure the degree of~          immune memory) affects the body's response to the booster, and~        4. if the age at which the vaccination was initiated during infancy affects duration of~          protection against hepatitis B among adolescents 16-19 years of age born in the United~          States who were immunized against hepatitis B as infants. These data will be important~          to evaluate the potential need for a possible booster dose of hepatitis B vaccine among~          adolescents.~      Study subjects eligible for enrollment will:~        -  have blood drawn for baseline serologies~        -  receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug~          dose)~        -  have blood drawn again 14 days later to determine if the booster dose has engendered an~          anamnestic response (a response attributed to prior immunity rather than a new response~          to the vaccine)~      The primary hypothesis is that the majority of young people will exhibit immune memory for~     hepatitis B in response to a booster dose of vaccine.~   "
169934|NCT01341262|"~     The marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory~     multiple myeloma (MM) provided the basis for this phase 2 clinical study aimed at~     investigating the efficacy and toxicity of thal-dex incorporated into melphalan-based double~     autologous stem cell transplantation (ASCT)for patients less than 65 years old with newly~     diagnosed symptomatic MM. Thal-dex was given as primary induction therapy and was then~     continued throughout the subsequent treatment phases until the day before the second~     autotransplantation. Primary study endpoints,as evaluated on an intention to treat basis, are~     response rates to the different treatment phases (induction, first and second ASCT), best~     response whenever achieved, duration of response (DOR), time to progression (TTP),~     progression free survival (PFS)and toxicity profile of thal-dex. Secondary endpoints, as~     evaluated on an intention to treat basis, are overall survival (OS) and clinical outcomes~     (DOR, TTP, PFS and OS)according to prognostic factors, including cytogenetic abnormalities~     and imaging features, as detected by 18F-FDG PET/CT.~   "
169935|NCT01341249|"~     The purpose of this study is to compare and explore pharmacokinetics of zabofloxacin, the~     main component of DW224aa(Test drug) and DW224a(Reference drug).~   "
169936|NCT01341236|"~     This study aims at recruiting about twenty very low birth weight infants, either intrauterine~     growth restricted (IUGR) or NON-IUGR~      STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10~     children) and NON-IUGR infants (approximately 10 children).~      PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in~     VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).~      SECONDARY ENDPOINT:~        -  To compare if changes in the intestinal perfusion induced by feeding are different~          between IUGR and NON-IUGR infants;~        -  To compare growth and nutritional status of the 2 groups by randomized arm.~        -  To evaluate if changes of intestinal perfusion and oximetry induced by feeding are~          related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of Near~          Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the~          transitional period, between the 48th and 72nd hours of life, all infants' intestinal~          perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery~          will be executed.~        -  To test if changes in intestinal oximetry and perfusion can be reliable predictors of~          feeding intolerance (need of interruption of enteral feeding).~      DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including~     20 VLBW babies. Duration of the study: 24 months.~      INCLUSION CRITERIA~        -  Weight at birth ranging: 700 - 1501 grams;~        -  Gestational age up to 25 weeks and 6 days;~        -  Written informed consent from parents or guardians~      EXCLUSION CRITERIA~        -  Major congenital abnormality (severe heart or cerebral disease, chromosomopathies,~          severe renal malformations, any malformation or disease of the gastroenteric tract)~        -  Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal,~          cardiac or cerebral impairment, DIC)~        -  Pre-existing cutaneous disease not allowing the placement of the probe~   "
169937|NCT01341223|"~     The use of amniotic membrane in ophthalmic surgery has been shown to provide an alternative~     for corneal and conjunctival reconstruction in many clinically challenging situations. It has~     without doubt provided an option where previously none existed in some conditions.~     Nevertheless, it is has its limitations and is not universally successful for every~     indication. The indications for its use are ever increasing, often on anecdotal evidence. In~     some instances where it is successfully used, existing and at times simpler options are~     equally effective. The collective global experience with the membrane is now vast, and the~     field should now move into proper randomized controlled studies to evaluate its true~     potential.~   "
169938|NCT01341210|"~     This is a cross-sectional, observational and correlational survey study.This study is aim to~     survey the the knowledge, attitudes, and decision making towards clinical trials in cancer~     patients in Taiwan (R.O.C.), which attempts to invite some cancer patients who have been~     experienced the treatment clinical trials' informed consent process. The research tool is a~     questionnaire which includes some scale: (1)Clinical trial Knowledge scale, (2) Attitude~     toward randomized clinical trials scale, (3) Shared Decision Making(SDM-Q-9),(4) Satisfaction~     with Decision (SWD-scale), and (5) Decision Regret scale(DRS). The investigators expect the~     research outcome can provide some instructions to improve patients' autonomy, satisfaction of~     the decision making and communication process between patients and Medical professors~     whenever cancer patients participating in clinical trials.~   "
169939|NCT01341197|"~     Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic~     gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is~     increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts with~     human globin, a protein that is digested by upper GI enzymes and is specific for detecting~     lower GI bleeding. However, in Taiwan, although the incidence of colorectal cancer is rapidly~     increasing, Helicobacter pylori-related upper GI pathologies remain highly prevalent, which~     may imply that mass screening solely based on I-FOBT could be insufficient as significant~     upper GI pathologies can be missed. Since I-FOBT dose not predict upper GI pathologies, the~     adjuncts of G-FOBT and H. pylori stool-antigen test (HpSA) may be a potential candidate to~     realize a pan-detecting assay based on stool samples in a population in which both lower and~     upper GI lesions are equally prevalent.~   "
169940|NCT01341184|"~     Evaluation of effect of rifampin or rifabutin on single dose PK of TMC207 in healthy~     volunteers~   "
169941|NCT01341171|"~     Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.~   "
169942|NCT01341158|"~     The current clinical trial shall clarify the efficacy, safety and biologic effects of~     neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional~     metastases of melanoma in stage IIIB/C.~   "
169943|NCT01341145|"~     The goal of this study is to determine if aerobic exercise or progressive muscle relaxation~     is associated with changes in cardiovascular health, brain function, and cognition.~   "
169951|NCT01341041|"~     This research is being done because the investigators are trying to examine the safety and~     effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are~     trying to see if this liquid has the ability to decrease infection rates and decrease the~     scarring effects from the healing process. In animal studies, CACD has been shown to decrease~     scar formation and decrease the risk of wound infections. CACD is also used for the treatment~     of burns to decrease infection rates and improve wound healing. CACD is not FDA approved for~     this specific use, but it is FDA and USDA approved for reducing bacterial contamination on~     meat and food products for human consumption. In addition, an investigational drug (IND)~     application has been submitted to the FDA for this study. The FDA has approved the use of~     this solution for this study.~   "
169952|NCT01341028|"~     -  Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is considered a combination of~          restriction-malabsorption procedure and one of the most common operative procedures~          implemented.~        -  Over the last years increasing evidence suggests that the beneficial effects of~          bariatric operations might be related to the suppression of appetite caused by the~          release of the anorectic gut hormones such as peptide-YY (PYY) and glucagon-like~          peptide-1 (GLP-1)by the L cells of the distal gut and the suppression of the orexigenic~          hormone ghrelin released by the stomach.Obese people have a blunted rise in PYY and~          GLP-1 after a meal, possibly resulting in impaired satiety and hence greater food~          intake.~        -  In the present study the investigators sought to evaluate the effects of the resection~          of the gastric fundus, the main source of ghrelin production, on the secretion of~          ghrelin, PYY, GLP-1 and insulin and in addition on glucose levels, appetite and weight~          loss, in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass.~   "
169953|NCT01341015|"~     Objectives:~      A lot of children who injure their ankles come to the emergency department for an evaluation,~     and often an X-ray of the ankle is obtained to determine if a bone fracture is present. In~     more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be~     treated with rest, ice, elevation, and pain medications. X-rays obtained in the emergency~     departments are time consuming, often uncomfortable for the patient, and expose children to~     radiation, the long-term effects of which are not yet fully understand by doctors or~     scientists. Bedside ultrasound is a non-invasive and a non-painful device that does not~     produce radiation. It was been shown to determine the presence of bone fracture in childrens'~     wrists and forearms just as well as X-rays do. In our study, the investigators would like to~     determine if a bedside ultrasound can also be used to evaluate ankle fractures in children.~      Research Procedures:~      In our study, the investigators will ask the parents and children, who are scheduled to get~     an X-ray of their ankle in the emergency department, to examine their ankles with an~     ultrasound machine as well. Since the bedside ultrasound is not significantly time-consuming,~     does not require patients to remain still, and is readily available in the department, the~     procedure will be performed while kids are waiting to get an X-ray, getting registered, or~     awaiting further treatment. On the data collection form, the investigators will document the~     patients' names, birthdates, medical record numbers so that their X-ray results can be~     compared to the ultrasound results for the purpose of the study. The information will be~     stored in a secure cabinet in a locked office. The investigators will also document which~     side is injured, where the patient feels pain and what the ankle looks like to help perform~     the ultrasound. The results of both the ultrasound and X-ray will be documented for each~     patient.~   "
169954|NCT01341002|"~     The objective of this study is to estimate red blood cells (RBC) transfusion related to~     central venous O2 saturation (ScvO2) measurement. This prospective, randomized trial is~     performed in visceral, vascular and thoracic surgery units in the university hospital of~     Lille.~      One hundred patients need to be included. Inclusion criteria are: age 18 to 99 year old,~     patient with central venous catheter in place and fulfilling the haemoglobin (Hb) threshold~     criteria for RBC transfusion according to the XXIIIth French Consensus Conference in critical~     care medicine recommendations.~      After randomisation, patients will be eligible to receive RBC according to their level of Hb~     in the standard group and according to the Hb and ScvO2 in the optimization group. Patients~     without any disease are transfused if their Hb level is below 7g/dL; patients older than 60~     years or having sepsis are transfused if their Hb level is 8g/dL or lower and cardiac~     patients are transfused if their Hb level is 9g/dL or lower. In the second group, transfusion~     is performed if and only if the ScvO2 level is les than 70% when Hb is under the same~     threshold levels.~      The primary aim of the study is to compare the number of RBC units transfused by group~     (standard group or optimization group) over a period of 5 days counted from the first~     decision of transfusion taken post-operative. Considering the randomisation and considering~     the 50 % reduction of the decisions of transfusion in the group optimization, the absolute~     blood savings is estimated 25 % for the whole population. Secondary end points include the~     number of side effects associated with transfusion or when avoiding transfusion, length of~     hospital stay, and hospital mortality as well as major adverse events.~   "
169955|NCT01340989|"~     CO2 absorption from the pneumoperitoneum increases over time during laparoscopic procedures.~     Adding 4% of oxygen to the carbon dioxide was shown in rabbits to decrease CO2 resorbtion~     through prevention of mesothelial hypoxia. We want to prove this concept in human and expand~     it to the use of full conditioning.~   "
169956|NCT01340976|"~     This study will evaluate the safety LY2787106 in participants with cancer and anemia. It will~     also evaluate when LY2787106 can improve anemia. This study has two parts: Part A is a dose~     escalation evaluation. Part B is an evaluation of LY2787106 at a defined dose given with and~     without iron supplementation.~   "
169957|NCT01340963|"~     The study investigated 100 subjects, both genders, with chronic Chagas disease, confirmed by~     at least two distinct serological tests, and classified according to Los Andes classification~     in a long term follow-up aiming at identifying the predictive value of the signal-averaged~     electrocardiogram for cardiac death and ventricular tachycardia.~      All subjects admitted to the study were submitted to clinical history taking, physical~     examination, and noninvasive assessment, including blood pressure measurement, resting~     12-lead surface electrocardiogram, 24h ambulatory electrocardiogram monitoring,~     M-Mode/two-dimensional echocardiogram, signal-averaged electrocardiogram in both time and~     frequency domains. Selected subjects were further submitted to treadmill stress test and~     coronary angiography to rule out coronary heart disease.~      Subjects were followed by non-investigational primary care assistance at three to six months~     scheduled clinical visits on an outpatients basis. Both noninvasive and invasive evaluation~     during follow-up were requested at discretion of primary evaluation. Adverse outcomes were~     ascertained by review of medical records and active contact to either study subjects or their~     relatives.~   "
169958|NCT01340950|"~     This primary aim of the project is to determine the association between antiretroviral~     therapy that better distributes into the central nervous system and prevention of~     HIV-associated neurocognitive impairment.~   "
169959|NCT01340937|"~     This study will determine whether three manufacturing lots of V419 (PR5I) induce similar~     immune responses to all of the antigens contained in V419 when given concomitantly with~     Prevnar13™ and RotaTeq™.~   "
169961|NCT01340911|"~     The main purpose of the study is to see how safe SRT3025 (study drug) is when given at~     different doses. The study will also investigate how the study drug is taken up, metabolised~     (chemically broken down), distributed through the body and excreted. A further aim is to look~     at how taking the study drug after eating might change this process.~   "
169962|NCT01340898|"~     This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK~     134612 in healthy infants, when co-administered with other infant vaccines, on three~     different dose schedules.~   "
169963|NCT01340885|"~     The purpose of this study is to determine the relationship between attention and quality of~     life and how rivastigmine and atomoxetine alter attention in non-demented persons with~     Parkinson's disease (PD).~   "
169964|NCT01340872|"~     The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation,~     is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with~     non-active ulcerative colitis (UC).~   "
169965|NCT01340859|"~     The broad objective of this research is to effectively utilize a unique window of opportunity~     during the hospitalization period following a recent suicide attempt to deliver a brief and~     targeted intervention for suicidal individuals.~   "
169966|NCT01340846|"~     GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that~     is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study~     (in 4 separate cohorts of subjects) designed to examine the interaction potential of~     GSK2118436, either as a perpetrator (i.e., effect of GSK2118436 on warfarin; Part A) or~     victim (i.e., effect of other drugs on GSK2118436; Part B: ketoconazole and Part C:~     gemfibrozil), as well as to evaluate the single and repeat dose pharmacokinetic parameters of~     GSK2118436 (Part D). A sufficient number of subjects will be screened to obtain approximately~     12 evaluable subjects each for Part A, Part B, Part C and Part D. Following completion of~     this study, subjects may continue dosing with GSK2118436 in the roll-over study, Protocol~     BRF114144.~   "
169967|NCT01340833|"~     GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that~     is currently being developed for the treatment of BRAF mutation-positive tumors. This is an~     open-label, non-randomized study designed to determine the absolute bioavailability of an~     oral dose of 150 mg of GSK2118436 co-administered with an intravenous 50 microgram dose of~     [14C]GSK2118436 in subjects with BRAF mutant solid tumors. Pharmacokinetic samples will be~     obtained up to 72 hours post-dose. Safety assessments will be performed throughout the study.~     After completing all assessments, eligible subjects may transition to BRF114144, an~     open-label, rollover study of GSK2118436 to continue treatment.~   "
169968|NCT01340820|"~     The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in~     healthy, BCG-naïve adults.~   "
169969|NCT01340807|"~     Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are~     at risk of functional decline, joint degeneration, skin breakdown and further limb loss due~     to the forces placed on the contralateral limb through prosthetic ambulation. If specialized~     prosthetic gait training and proper use of the appropriate prosthetic foot can decrease~     forces on the intact limb, the long term health and quality of life of veterans with~     amputations could be substantially improved. We will address two key questions:~      Key Question 1: After receiving specialized gait training and a new prosthetic socket, will~     subjects demonstrate differences in gait symmetry and external mechanical work between the~     bionic and conventional prosthetic feet, while performing various functional activities.~      Key Question 2: Can external mechanical work be used as a clinically friendly measure to~     differentiate between prosthetic feet?~   "
169970|NCT01340794|"~     This phase II trial studies how well pazopanib hydrochloride works in treating patients with~     advanced or progressive malignant pheochromocytoma or paraganglioma. Pazopanib hydrochloride~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and~     by blocking blood flow to the tumor.~   "
169971|NCT01340781|"~     The prevalence of obstructive sleep apnea (OSA) in patients admitted to the hospital is~     likely significantly higher than the general population as hospitalized patients carry a high~     prevalence of co-morbid conditions, such as diabetes and cardiovascular diseases, that are~     commonly associated with OSA. The true prevalence of OSA in hospitalized patients is not~     known, though there is limited data suggesting that the rate of OSA in hospitalized patients~     is indeed high. Two studies have reported on the rate of polysomnographic (PSG) diagnosis of~     OSA in patients referred for OSA evaluation while in-hospital. These studies reported~     frequencies of 77% (in a retrospective study of 100 patients) and 88-100% (in an~     observational study of 250 patients). Similarly, 2 studies evaluated the prevalence of sleep~     disordered breathing in patients admitted with acutely decompensated heart failure, finding~     frequencies of sleep apnea in 97% (prospective study of 29 patients studied with PSG) and 75%~     (prospective study of 395 consecutive patients studied with portable monitors). However, all~     of these studies are limited by either study design (retrospective), small numbers, limited~     channel portable monitoring, or evaluations of highly select patient populations.~     Furthermore, none of these studies examined screening tools that may help to identify which~     patients are at risk for OSA and thus might require the more extensive and expensive~     objective testing.~      This study will test the following hypotheses:~        1. The prevalence of OSA in unselected hospitalized medical patients will be more than 50%~          of the study population.~           Specific Aim 1: To determine the prevalence of OSA in a group of unselected hospitalized~          medical patients by a combination of sleep symptoms and PSG performed while in-hospital.~        2. Screening tools will be able to accurately identify OSA in hospitalized medical~          patients.~      Specific Aim 2: To determine the accuracy of different screening questionnaires for the~     diagnosis of OSA in hospitalized medical patients by comparing the questionnaire results to~     that of a PSG performed while in-hospital.~   "
169972|NCT01340768|"~     This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment~     versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who~     regularly take an SU drug, and choose to fast during the month of Ramadan. The primary~     hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or~     without metformin) compared to SU treatment (with or without metformin) results in a lower~     incidence of hypoglycemia in participants with T2DM.~   "
169973|NCT01340755|"~     Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at~     Massachusetts General Hospital and performed successfully to remove cancer of the lower~     rectum. Based on the outcomes, the research doctors believe that this investigational surgery~     may be as safe and effective as standard laparoscopic or open surgery performed to remove~     rectal cancer, may facilitate the operation and reduce the size of the abdominal incisions.~     In this research study, the investigators are looking to see if this investigational~     procedure is a safe and effective approach to remove rectal cancer of the mid and lower~     rectum.~   "
169974|NCT01340742|"~     Major abdominal surgeries are associated with perioperative cardiac morbidity of up to 10%.~      Ischemic preconditioning may have a protective effect. The purpose of this study is to find~     out remote ischemic conditioning by inflating a blood pressure cuff on the arm will have a~     protective effect.~   "
169975|NCT01340729|"~     The goal of this clinical research study is to find the highest tolerable dose of TPI 287~     that can be given to patients with metastatic melanoma. Researchers want to find out if TPI~     287 can control the disease. The safety of TPI 287 will also be studied.~   "
169976|NCT01340716|"~     This is a randomized Clinical Trial to assess the effects of Tai Chi Chuan on blood pressure,~     respiratory muscle strength and functional capacity in patients after recent acute myocardial~     infarction.~   "
169977|NCT01340703|"~     The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or~     laser photocoagulation to the margin of the optic nerve, for the treatment of macular~     detachment associated with optic disc pits and to characterize retinal manifestations during~     treatment of optic pit maculopathy using optical coherence tomography (OCT). Vitrectomy with~     induction of a PVD at the optic disc without gas tamponade or laser photocoagulation appears~     to be an effective method of managing macular detachment due to optic disc pits. OCT scanning~     pre- and postoperatively suggests that peripapillary vitreous traction with the passage of~     fluid into the retina through the pit is the cause of the schisis-like separation seen in~     optic disc pit maculopathy.~   "
169978|NCT01340690|"~     This study will determine the nutritional efficacy of Polyunsaturated Fatty Acids (PUFAs) in~     combination with zinc and magnesium, in children and adolescents diagnosed with Attention~     Deficit/ Hyperactivity Disorder (ADHD). The nutritional efficacy has to be proven in~     agreement with the German Verordnung über Diätetische Lebensmittel (DiätV) and the~     corresponding European Directive 1999/21/EC. This objective is reached by performing a~     placebo-controlled supplementation study with a main efficacy criterion which is also being~     used in pivotal studies of stimulant and non-stimulant drugs, i.e. the treatment differences~     between final visit and baseline in the Attention Deficit Hyperactivity Disorder Rating~     Scale, Parent Version IV (ADHDRS-IV).~   "
169979|NCT01340677|"~     The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of~     canagliflozin in healthy volunteers.~   "
169980|NCT01340664|"~     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of~     canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are~     receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have~     inadequate glycemic (blood sugar) control.~   "
169981|NCT01340651|"~     The purpose of this study is to determine the safety and tolerability of ruxolitinib~     (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis~     (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF).~   "
169982|NCT01340638|"~     The working hypothesis in this study is that the supraglottic device COOKGAS provides seal~     pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery, are~     sommeted to both interventions.~   "
169983|NCT01340625|"~     This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35~     mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with~     that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company,~     Inc., following a single oral dose (2 * 0.4 mg/35 mcg chewable tablets) in healthy female~     adult volunteers administered under fasting conditions.~   "
169984|NCT01340612|"~     The STAT trial aims at comparing coiling versus coiling plus stenting in patients with~     aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous~     coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in~     addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to~     coiling alone.~   "
169985|NCT01340599|"~     This randomized pilot phase II trial studies the side effects and how well defined green tea~     catechin extract works in treating patients with localized prostate cancer undergoing~     surgery. Defined green tea catechin extract contains ingredients that may prevent or slow the~     growth of certain cancers.~   "
169986|NCT01340586|"~     The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg~     Apixaban in subjects with normal renal function and subjects with end stage renal disease~     (ESRD) maintained with hemodialysis.~   "
169987|NCT01340573|"~     This is a non-interventional study designed to evaluate the efficacy and safety of~     combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C~     (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and~     who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were~     enrolled into study.~   "
169988|NCT01340560|"~     Objective To evaluate the effect of local injury to the endometrium for implantation,~     pregnancy and live birth rates in ICSI -ET cycles with recurrent implantation failure.~      Design Randomized controlled clinical study. Setting A clinical will assist reproductive~     center of Selcuk University Meram Medical Faculty Hospital in the Konya, Turkey.~      Population A group of 100 women, who failed to conceive during one or more cycles of IVF and~     embryo transfer (ET), will treat with a long protocol for controlled ovarian~     hyperstimulation.~      Methods The IVF treatment and ET will precede by repeated endometrial biopsies, in a randomly~     selected 50 of a total of 100 women.~   "
169989|NCT01340547|"~     This is an open-label study of palifosfamide-tris administered intravenously on Days 1, 2,~     and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will~     receive a placebo-control infusion on Day -1 and then commence palifosfamide-tris study~     treatment 24 hours later on Day 1.~      Time-matched, intensive ECG monitoring will occur during and following placebo and~     palifosfamide-tris infusions on Days -1, 1, 2, 3 and 8. Generation of ECG data for study~     analysis will be performed in a blinded fashion at a central ECG laboratory.~      Blood and urine sampling to characterize the pharmacokinetics of palifosfamide-tris will be~     performed on Days 1 through 8 of Cycle 1.~   "
169990|NCT01340534|"~     The purpose of this study is to determine if the use of supplemental oxygen at 80% FIO2 can~     reduce the incidence of surgical site infection after emergency cesarean section.~   "
169991|NCT01340521|"~     The goal of the study is to quantitatively evaluate pituitary hormone response, follicle~     stimulating hormone (FSH) and luteinizing hormone (LH), to low doses of clomiphene citrate in~     normally fertile women.~   "
169992|NCT01340508|"~     The hypothesis of this study is that dose escalated intensity modulated radiotherapy (IMRT)~     to a dose of 55Gy in 25# to primary rectal tumor concurrent with oral capecitabine results in~     an improved pathological response rate from 8% (German trial) to 25%.~   "
169993|NCT01340495|"~     In this study we are looking at a type of radiation called proton radiation which is known to~     spare surrounding tissue and organs from radiation. The proton radiation will be delivered~     using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton~     Radiation Treatment). Proton radiation delivers no dose beyond the region requiring~     treatment. This may reduce side effects that patients would normally experience with~     conventional radiation therapy or other means of delivering proton radiation therapy. In this~     study we are evaluating the effectiveness of using proton radiation delivered to reduce side~     effects association with radiation treatment.~   "
169994|NCT01340482|"~     The primary purpose of this study is to assess the safety and efficacy of repeated~     subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).~     A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone~     mineral density and bone quality.~   "
169995|NCT01340469|"~     The purpose of this study is to determine whether oral probiotic supplementation could reduce~     the incidence of nosocomial infections in preterm infants.~   "
169996|NCT01340456|"~     The objectives of this study are:~        -  To investigate if the endogenous cholesterol metabolite, 4beta-OHcholesterol could be~          used as a marker for induction of cytochrome P450 (CYP) 3A4.~        -  To compare 4beta-OHcholesterol with midazolam as a marker for induction of CYP3A4.~   "
169997|NCT01340443|"~     This observational study will evaluate the safety and efficacy of MabThera/Rituxan~     (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell~     lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during~     the 6 months of induction treatment and for up to 3 years of follow-up.~   "
169998|NCT01340430|"~     The main purpose of this study is to confirm the high pathologic complete response rate after~     neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in~     Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer~   "
169999|NCT01340417|"~     The general goal of the present study is to examine the developmental changes caused by~     melatonin in preterm and term newborns.~      The major brain lesions associated with cerebral palsy and cognitive impairment in preterm~     infants are periventricular white matter damage (WMD). At the present time, despite major~     improvements in neonatal care, there are no established therapeutic regimens for the~     treatment of brain lesions in preterms. Melatonin is secreted by the pineal gland;~     melatonin's neuroprotective action has been well documented in animal experimental models.~     Neuroprotection is believed to stem from its direct free radical scavenging, indirect~     antioxidant activities.~      Originality Several reports have described melatonin secretion in older children, but only a~     few have observed melatonin concentrations during the first year of life. Very little is~     known about the fetal pineal melatonin synthesis and nothing at what prenatal age melatonin~     synthesis starts. Premature infants have a 3 months delay in the development of melatonin~     rhythmicity compared to full-term infants. One study found discordant data with decreasing~     melatonin value around term. The absence of longitudinal study and the low number of children~     included make the interpretation difficult of the secretion of melatonin at the newborn.~      Hypothesis: Infants born before 28 weeks gestation have melatonin deficiency (50pg/ml),~     compared to newborns at term (100pg/ml).~      Study design: prospective, longitudinal, multicenter trial in 3 Neonatal Intensive Care Units~     in Ile de France. Specific aim is to compare the developmental changes of melatonin in~     preterm and term newborns (200 infants and their mothers: 4 groups of 50 infants: 24-27GA +6d~     ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following:~        -  determine Melatonin creatinin excretion in preterm infants~        -  correlate between serum melatonin secretion and urinary melatonin and~          6-sulfatoxymelatonin excretion~        -  determine endogenous melatonin production in the human pineal~        -  correlate genetic variations between different levels of melatonin in premature infants~        -  assess clinical and neurological outcomes at term Clinical impact The present clinical~          project is part of a translational approach, expected data for infants born before 28~          weeks gestation is melatonin deficiency which should participate in determining the~          potential use of melatonin as a neuroprotectant in human preterm neonates.~   "
170000|NCT01340404|"~     The aim of this study is to demonstrate that cerebral velocities assessed by transcranial~     doppler (TCD) are more significantly decreased by SCT than by long-term transfusion program A~     multicenter, national, non-randomized, prospective study of paired cohort will be conducted,~     with 2 groups of exposed (SCT) and non-exposed (TP) patients.~   "
170001|NCT01340391|"~     An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients,~     who has sustained a distal radius fracture in need of splinting are requested to participate~     in the study.~   "
170002|NCT01340378|"~     The primary goal of this investigation is to describe perioperative thrombin generation in~     neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the~     coagulation changes that precipitate postoperative shunt occlusion.~   "
170003|NCT01340365|"~     To evaluate the effects of Tai Chi—a mind-body exercise--on age-related loss of physiological~     complexity (using fractal and entropy based measures), and to understand the relationship~     between complexity, function and adaptability, we will conduct a two-arm prospective~     randomized clinical trial. Our overarching goal is to evaluate if six months of Tai Chi~     training, compared to a waitlist control receiving standard medical care, can enhance~     physiological complexity and adaptability in older Tai Chi-naïve adults. Secondary goals of~     the study are to characterize the relationship between complexity biomarkers, measures of~     function, and resilience. This pilot study will inform a future more definitive trial by~     providing information on recruitment and retention, compliance, dose-dependent effects,~     preliminary estimates of effect size, and the optimal biomarkers of complexity, function, and~     adaptive capacity.~   "
170004|NCT01340352|"~     Working hypothesis and aims:~      To investigate the association between cervical length in non-pregnant women, and the risk of~     premature birth.~      The participants will be recruited from the HaEmek Medical Center delivery room registration.~     Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The~     investigators will invite them 3 month or more after delivery to ultrasound examination of~     the cervical length. The participants in the control group will be the women whom term~     delivery follows by chronological manner to those in study group. Data of the cervucal length~     will be collected at the time of the examination.~   "
170005|NCT01340339|"~     The aim of this study is to compare the efficacy of super-LED reverse phototherapy with the~     fluorescent reverse phototherapy in term and late preterm newborns.~   "
170016|NCT01340196|"~     The objective of this study is to evaluate the drug-drug interaction potential between BI~     201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV~     infection and/or Hepatitis B infection. Results of this study will serve as a basis for~     guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are~     coadministered.~   "
170508|NCT01333592|"~     The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as~     combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show~     inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.~   "
170006|NCT01340326|"~     Angiotensin-converting enzyme inhibitors and angiotensin-receptor blocker valsartan~     ameliorate ventricular remodeling after myocardial infarction (MI). Although the amount of~     those drugs used in previous clinical trials, therefore recommended in practical guidelines~     is maximum clinical dose, it has not been clearly demonstrated whether the recommended dose~     is more efficacious compared to lower dose commonly used in clinical practice. In addition,~     the impact of genetic polymorphism in neurohormonal system on the pharmacological effect has~     not been explored in the setting of post-MI remodeling.~      Therefore, the investigators evaluate whether submaximal dose, which are lower than those in~     major pivotal trials but typically used in clinical practice, can offer similar benefit in~     post-MI ventricular remodeling.~   "
170007|NCT01340313|"~     Caudal block is the world-widely used technique for an effective postoperative analgesia in~     children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually~     performed with a single-shot, proper dosage is required to achieve sufficient analgesic~     levels. Several clinical researches have been performed to assess the drug spread levels~     using mathematical equation, X-ray evaluation, and ultrasonography during caudal block in~     children. In our previous study using fluoroscopy, we obtained the results that the~     established weight-based doses provided adequate block levels for each type of surgery.~      Ultrasonography is precise tool to evaluate the spinal structures and can provide estimated~     information in real time during caudal or epidural block in children.~      The aim of this study is to evaluate the drug spread level with a weight-based doses using~     ultrasonography during caudal block in children and assess the reliability of the real time~     ultrasonography to determine the drug spread levels. After general anesthesia, the patient~     will be placed in lateral decubitus position for caudal block. Total 1.5 ml/kg of 0.15%~     ropivacaine will be injected into the caudal space. The spread level will be step-wise~     evaluated using ultrasonography at the injected drug dose of 0.5 ml/kg, 1.0 ml/kg, 1.25~     ml/kg, and 1.5 ml/kg.~   "
170008|NCT01340300|"~     Metformin is a medication that is commonly used in the treatment of diabetes. Recently small~     studies in cancer patients without diabetes suggest that metformin may benefit in lowering~     insulin levels. In those studies of patients with cancer but not diabetes, glucose (or sugar)~     levels in the blood are generally no lowered. Insulin and insulin-like growth factors affect~     the growth of cancer cells.~      This randomized study will compare different interventions; exercise, exercise and metformin,~     metformin alone, or a control arm. The investigators are not directly testing how either~     exercise or metformin affects your disease. The investigators are testing how they affect~     insulin levels in your body as well as other blood markers. The investigators believe that~     these blood tests may either be related to cancer recurrences or be an early sign of cancer~     recurrences and they are testing how both exercise and metformin may change those markers.~   "
170009|NCT01340287|"~     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable~     low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in~     midly hypercholesterolemic people not treated by statins.~   "
170010|NCT01340274|"~     Nova Scotia is experiencing a proliferation of gambling opportunities and their related~     gambling problems. The 2003 Nova Scotia Prevalence Study (2004) found that approximately~     50,000 adult Nova Scotians are at some risk for problem gambling and that approximately~     93,000 adult Nova Scotians are intimately connected to at least one person who has a gambling~     problem. The serious consequences of problem gambling are being felt by the Individuals~     engaging in Problem Gambling (IPGs), their Concerned Significant Others (CSOs) and their~     Communities.~      Very few IPGs access support services for their gambling problems. Some reports (National~     Gambling Impact Study Commission 1999) have found that only 3% of IPGs seek treatment. The~     Nova Scotia Gambling Prevalence Study (2004) states: Overall, 3.5% (26,000 adults) have been~     motivated to help someone else with a current gambling problem versus 0.5% (3,700 adults)~     seeking assistance or information for a personal problem. While the CSOs of IPGs are seven~     times more likely to access professional addiction treatment the options for these~     individuals are limited and treatment programs often lack evidence in support of their~     effectiveness.~      The Community Reinforcement and Family Training (CRAFT) (Meyers & Wolfe 2004) approach~     provides significant benefits to the CSOs of persons abusing alcohol and other drugs. They~     benefits include: improvement in the quality of life of the CSOs; increasing the rate of~     substance abusers entering treatment; and decreased substance use. CRAFT empowers CSOs by~     providing tools to positively influence theirs and their significant other's behavior.~      The current study investigates the applicability and effectiveness of the CRAFT approach to~     the CSOs of IPGS.~      It is predicted that benefits to the CSOs receiving CRAFT will significantly surpass those~     receiving treatment as usual. The predicted benefits are: improvement in quality of life for~     the CSO; engagement of IPGs in treatment; and decreased gambling by the IPGs. With these~     achieved outcomes, this research will provide opportunity for earlier intervention, improved~     individual and family functioning and a reduction of the negative impact of problem gambling~     on the community.~   "
170011|NCT01340261|"~     The purpose of this study is to describe the demographic, medical, and~     psychological/behavioral characteristics of children and adolescent patients admitted to the~     Cleveland Clinic Children's Hospital's Pain Rehabilitation Program. The data will also be~     used to evaluate the clinical outcomes of patients admitted to the program as well as to~     examine the impact of various background factors on clinical outcomes.~   "
170012|NCT01340248|"~     A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect~     on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy~     male volunteers.~   "
170013|NCT01340235|"~     Dowling Meara type of epidermolysis bullosa simplex (EBS-DM) is a rare genodermatosis due to~     keratin 5 and 14 mutation, characterized by skin fragility and spontaneous or post traumatic~     blisters. Neonatal period and infancy are critical since this autonomic dominant affection~     usually improves with age. Cyclins seem to be efficient in some cases of EBS but are~     prohibited in children younger than 8 years old. Erythromycin can be a good alternative in~     this population due to its antibacterial and anti-inflammatory potential.~      The aim of this study is the evaluation of the efficiency of oral erythromycin to decrease~     the number of cutaneous blisters in severe EBS-DM patients from 6 months to 8 years old after~     3 months of treatment.~      Primary end point is the number of patients with decrease of blisters' number of at least 20%~     after 3 months of treatment by oral erythromycin.~      It is a preliminary study on 8 patients. Treatment is oral erythromycin twice a day during 3~     months. Follow up for each patient is 5 months. The duration of the study is 1 year.~   "
170014|NCT01340222|"~     The threat of preterm labour (PTL) is the first cause of hospitalization in the course of~     pregnancy. Its diagnostic is based on clinical examination with a positive predictive value~     of about 40 %. The role of the Monocyte chemotactic protein-1 (MCP-1) in delivery has been~     suggested by its secretion in the amniotic fluid during labour and by the increase in the~     expression of its RNA messengers in the peripheral maternal blood. We have also shown that~     the proportion of MCP-1-expressing monocytes is higher in women with vaginal delivery~     compared with those with caesarean delivery prior the onset of labour.~      OBJECTIVES : Primary To seek link between the respective proportions of circulating maternal~     monocyte and lymphocyte subpopulations and the true onset of PTL characterised by delivery~     occurring within 7 days post admission. Secondary: to (1) compare the predictive values of~     these new markers with those currently used, e.g. quantification of fœtal fibronectin and~     assessment of cervical length and effacement, (2) Compare the respective proportions of~     monocytes and lymphocyte subpopulations in maternal blood and fœtal membranes, (3) determine~     if a correlation exists between the activation markers expressed by maternal monocyte and~     lymphocyte subpopulations and the neonatal outcomes of preterm infants.~      MATERIAL AND METHODS: 200 patients with a singleton pregnancy between 24 and 34 weeks of~     amenorrhea and complicated PTL, will be prospectively included in the maternity wards of~     Galway (Ireland) and of Dijon with the support of the perinatal network of Burgundy. A 2X5ml~     blood sample will be collected upon admission, at D1, D2, D4 and D6 for women who did not~     deliver within the first 7 days; finally, another blood sample will be drawn upon discharge.~     After delivery, foetal membranes will be collected to characterize and compare the various~     monocyte and lymphocyte subpopulations in the maternal blood. The characterization and the~     study of the level of activation of blood and foetal membrane cells will be performed using~     flow cytometry technique with suitable markers. The main judgment criteria will be the~     percentage of monocytes positively expressing MCP-1 for all three monocyte subpopulations~     (inflammatory, residents or patrollers and intermediates, according to CD14, CD16, CCR2~     and MCP-1 markers. Lymphocyte subpopulations will be assessed using the following markers:~     CD45, CD3, CD4, CD8 (T lymphocytes), HLA-DR (activated T lymphocytes), CD19 (B lymphocytes),~     CD16/CD56 (NK Cells), intracellular IFN-gamma (Th1 lymphocytes), intracellular IL-4 (Th-2~     lymphocytes), intracellular IL-17 and CCR6 (Th17 lymphocytes), CD4, CD25, Foxp3 and CD127~     (Tregs). Univariate statistical analysis of quantitative data will be performed using the~     Mann and Witney test or ANOVA, after verification of the conditions of application. The~     comparisons of percentages will be done using Chi-square Pearson tests and the Fisher's exact~     test, as appropriate. The multivariate analysis will be performed using a stepwise descending~     analysis.~      TRANSLATIONAL DIMENSION: The characterization of the various monocyte and lymphocyte~     subpopulations in the maternal blood and in the foetal membranes might constitute an ~     immunological signature  of the labour and therefore validate the relevance of a predictive~     marker for clinicians.~      EXPECTED RESULTS AND PERSPECTIVES: The study of the various monocyte and lymphocyte~     subpopulations in the maternal blood will allow to better characterise the immunological~     mechanisms occurring at the start of premature labour and to identity predictive markers of~     the preterm delivery, to validate prospectively in order to optimize the management of PTL~   "
170015|NCT01340209|"~     The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over~     a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered~     by the Respimat inhaler will be examined on top of maintenance treatment with inhaled~     corticosteroid controller medication in patients with moderate to severe persistent asthma.~     Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma~     exacerbations, effects on asthma control, and number of adverse events.~   "
170017|NCT01340183|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of the~     drug AZD5099 after intravenous administration of single doses in healthy volunteers. The~     results from this study will form the basis for decisions regarding the future development of~     AZD5099 as a novel antibiotic for the treatment of serious infections in humans.~   "
170018|NCT01340170|"~     The study objective is to establish that there is no statistical difference in marginal bone~     level change comparing a Standard drilling protocol with a Soft bone drilling protocol when~     using OsseoSpeed TX and immediate loading.~   "
170019|NCT01340157|"~     The present study is designed to assess the impact of concomitant food intake on the relative~     bioavailability of a single oral fexinidazole tablet administration.~   "
170020|NCT01340144|"~     Analyze clinical data for a group of subjects implanted with a new surgical device designed~     to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that~     to a control group of subjects implanted with a TKA design known to have an incidence of~     patellar crepitus of approximately 5%.~   "
170021|NCT01340131|"~     The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828~     (Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.~   "
170022|NCT01340118|"~     Abnormal lung function and high exhaled nitric oxide (FeNO) have been reported in~     asymptomatic patients with asthma. The investigators aimed to assess whether FeNO and~     FEF25-75 improve concurrently after treatment with inhaled corticosteroid (ICS) in patients~     with controlled asthma. Geometric mean (GM) FeNO and spirometric values in patients 8 to 16~     years of age who maintained asthma control without controller medication were compared with~     healthy controls and patients with uncontrolled asthma who were also not receiving controller~     medications. Patients with controlled asthma and high FeNO (> 25 ppb) were randomized to ICS~     treatment or to remain untreated. Changes in spirometric values and GM FeNO from baseline~     were evaluated after 6 weeks.~   "
170023|NCT01340105|"~     The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue~     Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip~     radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).~      The investigators hypothesize that microwave ablation can achieve a better complete ablation~     rate as compared to radiofrerquency ablation.~      A randomized comparative study is performed by randomly assigned participants to microwave~     ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by~     the complete tumor ablation rate at 1 month, recurrence rate and survival time of~     participants. Safety of the procedures is also compared between the 2 treatment arms.~   "
170024|NCT01340092|"~     The purpose of this study is to see whether or not Family Navigators, who 1 ) help families~     after their child is diagnosed with autism and help them get autism specific services for~     their child 2) help families identify barriers to obtaining these services and 3) help~     families problem solve to overcome these barrier, are helpful to parents of a child newly~     diagnosed with an Autism Spectrum Disorder.~   "
170025|NCT01340079|"~     Comparison of 2 methods of delivery health education for African-American women with Type 2~     Diabetes. The two methods are: face to face education in small groups, as compared to~     delivering the same curriculum in the virtual world, Second Life.~   "
170026|NCT01340066|"~     The purpose of this study is to determine if a new drug treatment is effective for the~     treatment of symptoms of urinary incontinence.~   "
170027|NCT01340053|"~     This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of~     RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition~     of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery~     of screening procedures to determine eligibility for the trial.~      The study will consist of a 2-week treatment-free screening period, a 4-week blinded~     treatment period, and a 2-week treatment-free follow-up period.~   "
170028|NCT01340040|"~     The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in~     Japanese subjects with advanced solid tumours refractory to standard therapy or for which no~     standard therapy exists.~   "
170029|NCT01340027|"~     The purpose of this study is to examine how well two medicines in combination (solifenacin~     succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.~   "
170030|NCT01340014|"~     The purpose of this study was to assess patient preference regarding ocular comfort of~     AZARGA® compared to COSOPT® after one week instillation of each study medication.~   "
170031|NCT01340001|"~     Deep brain stimulation has been developed as a substitute for the classical lesioning methods~     previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases reports~     suggested that electrical stimulation of the cholinergic output of the Nucleus Basalis of~     Meynert (NBM) may improve cognitive performances, especially the memory tasks.~      The present study aims to assess the effect of bilateral electrical stimulation of the NBM on~     the mnesic performance [assessed by the sum of the three free recalls of the Free and Cued~     Selective Recall Reminding Test (FCSRT)] in patients diagnosed with probable, moderate,~     Dementia with Lewy Bodies.~   "
170032|NCT01339988|"~     Long-term follow-up studies have demonstrated significant late toxicities of total body~     irradiation (TBI), which are most marked in children radiated at a young age. Growth failure,~     decline in cognitive function, and endocrine abnormalities have all been described. Good~     outcomes can be achieved with alkylating agents only as a preparative regimen. This plan will~     use a combination of busulfan and cyclophosphamide (Bu/Cy) with or without antithymocyte~     globulin (ATG) to reduce the late toxicities of therapy that includes TBI.~   "
170033|NCT01339975|"~     Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a~     constant increase in its mortality and consequently requires an important involvement in~     translational research.~      The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers~     in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown~     anti-angiogenic and anti-tumor properties in experimental models and may be particularly~     interesting for prognostic and predictive purposes.~   "
170509|NCT01333579|"~     Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected~     hemisphere (UH) transiently improves motor function in patients in the chronic phase after~     stroke. The goal of this study is to investigate effects on motor recovery of low-frequency~     rTMS of the UH, administered in the subacute phase after stroke.~   "
170034|NCT01339962|"~     Non-interventional study. Data obtained by patient chart reviews.~      Retrospective analysis of progression free survival, time to treatment failure and overall~     survival in a national cohort of patients with metastatic renal cell carcinoma treated in~     Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity~     assessed by Charlson Comorbidity Index.~      The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus,~     Aldesleukin, Interferon-alfa-2b.~   "
170035|NCT01339949|"~     The objective of this study is to confirm the safety and to establish the effectiveness of~     low voltage external beam radiosurgery using the IRay System for the treatment of subjects~     with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as~     determined by decreasing the number of Lucentis injections required during the first 12~     months of the study.~   "
170036|NCT01339936|"~     The main objectives of the investigation will be to assess the effect of the repeated usage~     of an investigational eye drop on the tear film characteristics of dry eye sufferers and~     demonstrate the benefit of this eye drops for dry eye sufferers.~   "
170037|NCT01339923|"~     The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when~     administered alone without routine infant vaccines to healthy infants in their first year of~     life according to different two and three dose immunization schedules, which are suitable to~     be adopted by various national programs. This study will also investigate antibody~     persistence post primary series and administration of a subsequent booster dose of rMenB+OMV~     NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of~     two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of~     age.~      This study will also evaluate the safety and immunogenicity of the concomitant administration~     of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and~     12-month schedule.~   "
170038|NCT01339910|"~     The study is designed as a Phase III, multicenter trial comparing outcomes after allogeneic~     hematopoietic stem cell transplantation (HCT) for acute myeloid leukemia (AML) or~     myelodysplastic syndrome (MDS) between patients receiving myeloablative conditioning (MAC)~     versus reduced intensity conditioning (RIC) regimens.~   "
170039|NCT01339897|"~     This Phase 1 study will evaluate multiple doses across a range that has been found to be~     effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to~     provide evidence of the tolerability of multiple doses as well as provide information on the~     Pharmacokinetic (PK) and metabolism of N6022 in humans.~   "
170040|NCT01339884|"~     The purpose of this study is to determine the effect of two doses of resveratrol taken for a~     12 week period, on frataxin levels in individuals with Friedreich ataxia. This study will~     also measure the effect of resveratrol on markers of oxidative stress, clinical measures of~     ataxia, and cardiac parameters.~   "
170041|NCT01339871|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of pazopanib and vorinostat that can be given to patients with advanced cancer.~     The safety of the drug combination will also be studied.~   "
170042|NCT01339858|"~     The primary objective of this study is to determine if NAC, added to existing antipsychotic~     treatment, is superior to placebo for cortical erosion in patients with early stage~     psychosis. The primary hypothesis is that there will be significantly less cortical erosion~     as measured by cortical thickness, cortical volume and cortical white matter density~     (assessed by DTI) in patients treated for 12 months with NAC as compared to those treated~     with placebo. The secondary objectives of this study are to determine if 12 months of NAC~     add-on treatment is superior to placebo for fMRI determined working memory and semantic~     memory tasks, cortical MR spectroscopy measures (glutathione, N-acetylaspartate, and~     glutamine/glutamate levels), electrophysiologically determined attention measures (e.g.,~     mismatch negativity, P300), symptoms, functional measures and cognitive functioning.~   "
170043|NCT01339845|"~     The purpose of this study is to conduct and evaluate the feasibility and effectiveness of a~     mass cholera vaccination program to reduce diarrhea due to Vibrio cholerae in a high~     incidence urban area. This study will also evaluate the feasibility of adding a household~     hand washing and safe drinking water promotion intervention to a cholera vaccine program and~     the overall impact of this combination on decreasing the incidence of diarrhea due to Vibrio~     cholerae.~   "
170044|NCT01339832|"~     This observational study is a follow-up study of protocol ML18280. Survival data of patients~     who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV~     of ML18270.~   "
170045|NCT01339819|"~     The aim of this study is to evaluate whether Dabigatran itself reduces ADP induced platelet~     aggregation measured by MEA as compared to Phenprocoumon after a two-week treatment with~     either agent.~   "
170046|NCT01339806|"~     The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in~     OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24~     months post injury) cognitive complaints. This is a prospective, randomized, control~     treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of~     mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive~     complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service~     at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the~     treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study.~     Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks~     following the initiation of the study. The total number of patients to be studied is 160~     (maximum), which is approximately 20 patients per month.~   "
170047|NCT01339793|"~     In recent years, many hospitals have progressively perceived the importance of corporate~     social responsibility (CSR). More and more hospital superintendents thus have realized that~     they should have a CSR strategy to deal with various stakeholders. Hospital, as a health care~     sector, is a labor-intensive industry. The management of hospitals should view its employees~     as salient stakeholders as well as a sort of precious asset by which hospital can possess a~     unique competition advantage in the operation. It is therefore important for superintendent~     to understand an employee's perspective on CSR and its impact on employees' work attitudes~     and organizational performance.~   "
170575|NCT01332721|"~     The purpose of the study is to evaluate safety and tolerability and determine a recommended~     Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced~     solid tumors for which bevacizumab is indicated.~   "
170048|NCT01339780|"~     Prostate and breast cancer continues to be the most common cancer among men and women,~     respectively. The exact assessment of the cancer spread with detection of possible bone~     metastasis is crucial for treatment decision. In the current study 50 patients with prostate~     cancer and 50 patients with breast cancer at high risk for bone metastases or with know~     metastatic disease will be studied with multiple imaging modalities. Patients will be~     recruited from the Department of Oncology, Turku University Hospital. Planar bone~     scintigraphy (BS), single photon emission computed tomography combined with low-dose computed~     tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT)~     and magnetic resonance imaging (MRI) will be performed to all patients. The primary objective~     is to determine the diagnostic accuracy of the four imaging modalities. The secondary goal is~     to calculate the sensitivities and specificities of the four imaging modalities on a~     patient-to-patient and lesion-to-lesion basis. Based on the results of this study an optimal~     imaging protocol for detection of prostate and breast cancer bone metastasis will be~     developed and validated.~   "
170049|NCT01339767|"~     The purpose of this study is to learn more about risk factors for autism by studying the~     behavior and brain functioning of toddlers with early communication delays and typically~     developing toddlers. Children 12 or 18 months of age with language delays (i.e., no words at~     18 months, limited vocalizations at 12 months) and typically developing toddlers may be~     eligible to participate. This study will be conducted at the NIH Clinical Center in Bethesda,~     Maryland. There will be an initial screening evaluation that will include behavioral~     assessment. Eligible participants will then complete a baseline visit that includes an~     overnight sleep study that includes Electroencephalogram (EEG) test to measure brain~     electrical activity, and an MRI scan. Follow-up visits that include behavioral assessment~     will occur every 6-12 months, depending on age at study entry. The final study visit will~     occur at 36 months of age and will include behavioral assessment, sleep/EEG study, and MRI.~     There is no cost for participation. Compensation will be provided. To find out if your child~     qualifies or for more information, please call 301-451-7822 (TTY: 1-866-411-1010) or e-mail~     NIMH-ASD@mail.nih.gov. National Institute of Mental Health, National Institutes of Health,~     Department of Health & Human Services....~   "
170050|NCT01339754|"~     RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with~     metastatic pancreatic cancer after first-line chemotherapy.~   "
170051|NCT01339741|"~     The purpose of this research is to study whether vitamin D supplement can improve clinical~     outcome (PASI score) in psoriasis vulgaris with vitamin D insufficiency and deficiency.~   "
170052|NCT01339728|"~     The purpose of the present study was to investigate the effect of far-infrared ray at CV12~     acupoints area on the skin temperature and skin blood flow of palm central area of right~     hand, and the correlation between them.~   "
170053|NCT01339715|"~     The purpose of the study was to investigate the changes of Ryodoraku value at 12 source~     acupoints, and heart rate viability (HRV) when acupuncture or far-infrared ray illumination~     applied to CV12 acupoint.~   "
170054|NCT01339702|"~     Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma~     Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in~     the prehospital EMS systems throughout the state of Arizona.~   "
170055|NCT01339689|"~     This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,~     15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress~     Disorder (PTSD). Up to 120 subjects will be enrolled and randomized to receive either~     ganaxolone or placebo for 6 weeks. After 6 wks of randomized treatment all subjects will~     continue for 6 wks on ganaxolone. The aim of the study is to assess the efficacy of~     ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment~     using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to~     evaluate the safety and tolerability of ganaxolone in the PTSD population.~   "
170056|NCT01339676|"~     This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4~     pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to~     subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis~     patients.~   "
170057|NCT01339663|"~     This phase I trial studies the side effects and best dose of autologous T-antigen-presenting~     cells (T-APC) vaccine following therapeutic autologous lymphocytes (CTL) and cyclophosphamide~     in treating patients with metastatic melanoma. Aldesleukin may stimulate lymphocytes, such as~     CTL, to kill melanoma cells. Treating lymphocytes with aldesleukin in the laboratory may help~     the lymphocytes kill more tumor cells when they are put back in the body. Vaccines made from~     melanoma antigen may help the body build an effective immune response to kill tumor cells and~     may boost the effect of the CTL. Drugs used in chemotherapy, such as cyclophosphamide, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving T-APC vaccine after CTL and cyclophosphamide may be an~     effective treatment for melanoma~   "
170058|NCT01339650|"~     This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and~     pharmacodynamics of ABT-767 in subjects with advanced Breast Cancer 1 or 2 gene (BRCA1 or~     BRCA2)-mutated solid tumors and high grade serous ovarian, fallopian tube, or primary~     peritoneal cancer.~   "
170059|NCT01339637|"~     The overall objective of this study is to increase the number of dark skin tone individuals~     in the data set and evaluate if this increase in dark skin tone data has an impact on the~     accuracy of the SCOUT DS Diabetes Risk Score (DRS).~   "
170060|NCT01339624|"~     The purpose of this study is to determine whether nasal fentanyl is effective in the~     treatment of renal colic in adults in emergency department.~   "
170061|NCT01339611|"~     The aim of the study is to test if patients under oral anticoagulation therapy who are going~     to participate in the education program will have better Health-related quality of life,~     higher rate in pharmacological treatment adherence and better self efficacy to manage the~     treatment.~   "
170925|NCT01328080|"~     This study is being done to evaluate the effect of targeted UV-B (a component of sunlight) on~     the treatment of acne keloidalis nuchae (AKN, or razor bumps on the back of the neck). The~     investigators believe targeted UV-B is a safe and effective way to reduce the appearance of~     AKN.~   "
170062|NCT01339598|"~     This study aims to investigate the potential for Transcranial Direct Current Stimulation~     (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the~     effect of active or sham tDCS (placebo control) during the performance of two cognitive~     tasks. The investigators hypothesize that task performance will be improved with active~     relative to sham tDCS.~   "
170063|NCT01339585|"~     This project will investigate a novel strategy for enhancing cognitive training (CT).~     Specifically, the investigators aim to combine a non-invasive form of brain stimulation~     (tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be~     administered either before or during CT.~   "
170064|NCT01339572|"~     This protocol will investigate the effectiveness of plerixafor in the up-front setting in~     avoiding a second round of mobilization and whether this translates into a clinical and~     economic benefit.~   "
170065|NCT01339559|"~     This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and~     single arm study of brivaracetam (BRV).~   "
170066|NCT01339546|"~     The rationale for this study is to assess the change in ambulatory care visit rates for acute~     otitis media between the period before (2001-2009) and after the introduction of the~     13-valent pneumococcal conjugate vaccine (13vPnC) (2011-2013) among children less than 5~     years old in the United States.~   "
170067|NCT01339533|"~     APRV mode of ventilation will result in an improved partial pressure of arterial oxygenation/~     fraction of inspired oxygen (P/F ratio) on day 3 of mechanical ventilation. Sub hypotheses:~     APRV will be associated with a reduced amount of sedation used during the ICU stay in~     patients with respiratory failure. APRV will be associated with a reduction in the amount of~     vasoactive medication used for blood pressure support in patients with respiratory failure.~   "
170068|NCT01339520|"~     The purpose of this study is to see if the use of a diabetic scorecard during clinic visits~     can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and~     amount of exercise in adults over age 40 with uncontrolled Type II diabetes.~   "
170069|NCT01339507|"~     The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after~     instillation.~   "
170070|NCT01339494|"~     Introduction~      Baylor College of Medicine and Texas Children's Hospital are recruiting individuals with~     MELAS syndrome for a clinical study. MELAS syndrome is a mitochondrial disease; patients with~     this disease have muscle weakness and often develop brain strokes, where blood does not flow~     normally to different parts of the brain. It is believed that these strokes could be due to~     decreased production of nitric oxide, a naturally occurring compound important for normal~     blood vessel function. Nitric oxide is made from arginine and citrulline that are normally~     found in our bodies.~      What is the purpose of this study? The purpose of this study is to measure nitric oxide in~     individuals with MELAS and see if giving arginine or citrulline will increase the formation~     of nitric oxide. Nitric oxide is thought to be helpful in preventing strokes. Therefore, if~     arginine and/or citrulline are shown to increase the formation of nitric oxide, they could be~     used to prevent or treat the strokes in patients with MELAS syndrome.~   "
170071|NCT01339481|"~     The purpose of this study is to characterize CD86 receptor occupancy in subjects with~     rheumatoid arthritis (RA) receiving abatacept.~   "
170072|NCT01339468|"~     The purpose of this study is to investigate and compare the pharmacokinetic parameters of~     tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.~   "
170073|NCT01339455|"~     Neuromyelitis Optica (NMO) is a demyelinating and degenerative disorder of the CNS affecting~     vision and spinal cord function. This disease is rare compared to Multiple Sclerosis (MS),~     but it is devastating and often leads to accumulating disability with a 5 year-mortality of~     approximately 30%. Survivors are typically left with severe morbidity secondary to blindness,~     quadriparesis and respiratory failure. No agent has been found to be highly effective in~     halting disease activity. Based on recent outcomes of stem cell transplant trials and reports~     in autoimmune diseases including MS, and based on the mechanisms of NMO, we anticipate that~     stem cell transplantation may provide lasting disease stability for NMO patients. The~     hypothesis of the present trial is that autologous hematopoetic stem cell transplantation in~     patients with NMO will provide lasting benefit in relapse prevention. Specifically, we~     anticipate a 50% reduction in the proportion of patients experiencing relapse over a three~     year period. We will be following patients for a total of five years after transplantation.~   "
170074|NCT01339442|"~     This phase I trial will determine the Maximum Tolerated Dose (MTD) of BKM120 when given~     together with fulvestrant in treating postmenopausal patients with estrogen receptor-positive~     (ER+) stage IV breast cancer. The toxicity profile of this combination therapy will also be~     described. Inhibition of PI3K by BKM120 may enhance programmed cell death (apoptosis) in~     estrogen receptor positive (ER+) breast cancer cells. Giving fulvestrant together with BKM~     120 may enhance this apoptotic effect, providing a novel therapeutic strategy for patients~     with metastatic ER+ breast cancer.~   "
170075|NCT01339429|"~     The objective of this study is to implement a simplified Negative Pressure Wound Therapy~     (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device~     is at least equivalent to commercially available NPWT devices. Therefore, the specific aims~     of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the~     adverse events associated with the sNPWT device.~   "
170076|NCT01339416|"~     Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins~     University, University of North Carolina and Vanderbilt University will be followed in the~     routine clinical care to estimate the rates of prespecified clinical events in this~     population.~   "
170077|NCT01339403|"~     Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry~     wil be followed in the usual clinical care to estimate the rates of specified clinical~     events. The rates will be stratified by relevant characteristics like age, CD4 counts, HIV~     Viral Load (VL), HIV medication history. The rates in the HIV infected cohort wil be compared~     with the rates of these events in patients in the Kaiser Permanente database who are not~     infected with HIV.~   "
170576|NCT01332708|"~     The investigators aims in the current study are to examine whether the cholinergic status~     should be considered as another risk factor for the metabolic syndrome and it's~     co-morbidities and to test the effect of a hypocaloric high complex carbohydrates diet on the~     cholinergic status of overweight and obese adults with and without the metabolic syndrome.~   "
170078|NCT01339390|"~     Obesity has been linked to several serious medical conditions, including high blood pressure,~     diabetes, and poor cholesterol levels. For this reason, obesity is likely the most important~     single contributor to cardiovascular mortality in the United States. Fortunately, intensive~     weight management programs are an effective treatment for obesity. Such programs help people~     lose weight and improve their measures of cardiac risk. In response to the growing numbers of~     obese Veterans being treated at Veterans Health Administration (VHA) facilities, the VHA~     developed the MOVE! Program. Veterans who commit to MOVE! and participate actively do lose~     weight. Unfortunately, MOVE!, like other weight management programs, requires its~     participants to attend classes and to exercise, often at locations and times that are~     inconvenient. The investigators propose to make it easier for eligible patients at the~     Zablocki Veterans Affairs Medical Center (ZVAMC) to participate by offering MOVE-style~     classes and exercise groups at a variety of locations, days, and times. The investigators'~     program-MOVE OUT-may provide a model for VHA to use nationwide.~   "
170079|NCT01339377|"~     To evaluate the safety and effectiveness of the AO-1000 device to treat and relieve the pain~     of symptomatic subjects with contained herniated discs. This single-arm pilot study will be~     used as a go vs. no-go decision on performing a randomized-controlled trial.~      The study's primary effectiveness objective is to demonstrate that the patient's~     functionality (based on Oswestry Disability Index scores) has improved from baseline at one~     month. The study's primary safety objective is to demonstrate that serious device/procedure~     related adverse events and subsequent surgical interventions are no greater than those in a~     literature control of other percutaneous disc decompression procedures at discharge, 1 month,~     6 months, and 12 months post-treatment.~      Secondary objectives are to demonstrate procedural success and improvement in the pain and~     function of the subjects at 1, 6, and 12 months using the VAS and ODI scales as well as~     tracking analgesic medication use. Pain and function scores for each follow-up time will be~     compared to the baseline scores.~   "
170080|NCT01339364|"~     This study is a three-arm randomized controlled trial to evaluate the effects of 1-day~     continuing educational meetings for community pharmacists with three distinct educational~     methods: 1) Didactic lecture 2) Didactic lecture plus case discussion in a large group 3)~     Didactic lecture plus small group education with simulated patient~      Knowledge and attitude of the participants would be measured as the study outcome in three~     periods: pre-education, post-education and 1 month after the meetings.~   "
170081|NCT01339351|"~     African American women with breast cancer have decreased quality of life (and mood when~     compared to European American. Research has not examined the effectiveness of therapeutic~     group for African American women with breast cancer even though positive effects are well~     established for Caucasians. The aims of the randomized clinical trial are to determine the~     effectiveness of TG by teleconference for African American women with breast cancer and what~     factors may impact on the intervention. The primary hypothesis is that participants in the~     intervention group will have significantly greater cancer knowledge, less fear, less~     isolation, better social connection, better mood, and better QOL when compared to a control~     group receiving usual psychosocial care. Two hundred forty African American women with breast~     cancer will be recruited. Intervention participants attend eight weekly 90 minute sessions by~     teleconference and two follow-up boosters. Each culturally appropriate session contains the~     story, information and group processes of connection, commonality and catharsis. Information~     focuses on increasing self care and stress management knowledge while countering myths and~     taboos. Story capitalizes on African American oral traditions by discussing coping parables.~     Group processes provide an alternative source of social support and opportunities to express~     feelings. Control group subjects receive standard psychosocial care (the use of any support~     programs or services locally or nationally. Testing will occur at baseline, after 10 group~     sessions and 16 weeks post baseline. The study findings are expected to inform about the~     effectiveness of therapeutic groups in African American women with breast cancer and lay the~     groundwork for exploring if reducing disparities in psychosocial care have a health benefit.~   "
170082|NCT01339338|"~     The purpose of this study is to compare the use of warm-media with cold-media in performing~     hysterosalpingography (HSG).~   "
170083|NCT01339325|"~     The aim of this study is to assess possible differences between the LESS approach and the~     standard laparoscopic approach to cholecystectomy. In particular, the Postoperative Quality~     of Life (QoL) will be investigated by analyzing the followings: length of hospital stay~     (LoS), postoperative pain, cosmetics and the results of SF 36 questionnaire. Furthermore,~     operative time, conversion to standard LC rate, difficulty of exposure, difficulty of~     dissection, and complication rate will be compared.~   "
170084|NCT01339312|"~     This study is designed to gather safety and immunogenicity data with Purified Vero Rabies~     Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule,~     using the Essen regimen, across different populations.~      Primary Objective:~        -  To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab~          vaccine, in terms of proportion of participants with a rabies virus neutralizing~          antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in~          participants aged 10 to 17 years and in participants aged 18 years and over.~      Secondary Objectives:~        -  To assess the clinical safety of VRVg after each vaccination when administered in a~          post-exposure prophylaxis vaccination schedule in each respective age group and overall~        -  To describe the immune response induced by VRVg before the fourth vaccination and 14~          days after the last vaccination in each respective age groups and overall.~   "
170085|NCT01339299|"~     The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study~     to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human~     chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in~     normogonadotrophic women.~   "
170111|NCT01338961|"~     Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a~     century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date,~     most studies have been conducted in coronary artery bypass graft (CABG) patients with~     conflicting results. Current evidence does not support one temperature management strategy~     for all patients. The purpose of this study is to compare the efficiency and safety of~     normothermic versus hypothermic CPB in valvular surgery patients.~   "
170086|NCT01339286|"~     Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with~     the prevalence of 3% to 6% in children and adolescents. The patients' academic achievements,~     professions and social livings are impaired. Comorbid antisocial behavior, substance abuse~     and delinquency burden family and society. Stimulants used to be the first line drug. But the~     medication compliance is poor because of strict drug administration. Atomoxetine is a new~     non-stimulant drug, which can effectively improve ADHD symptoms. But it achieves effect~     slowly, the drug responses differ significantly, and side effects interfere compliance. Since~     genetic factors is the most important cause for different drug responses, this project~     studies candidate genes potentially associated with atomoxetine medication, with the aim to~     find 2 to 3 gene polymorphisms influencing the drug response of ADHD. The study adopts cohort~     design. A sample of more than 100 ADHD cases with atomoxetine medication is to be collected.~     The rapid genotyping of large sample depends on high-through laboratory. New statistic method~     is to be used to improve the sensitivity of the target gene detection. There has been no such~     report in country and overseas. This project will provide basic information for forecasting~     drug response, improving clinical effects, tolerance and long-term compliance.~   "
170087|NCT01339273|"~     Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when compared~     to open large bowel resection, but is still associated with a significant amount of pain and~     discomfort. Analgesia is commonly provided by a multi-modal technique involving varying~     combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional~     analgesia and oral or parenteral opioids. While epidural analgesia is considered the gold~     standard for open colo-rectal procedures it can be associated with significant complications~     and may delay hospital discharge in laparoscopic procedures. Opioids are associated with an~     increased incidence of nausea, vomiting and sedation and reduced bowel motility which can~     also prolong recovery.~      Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain~     sensation from the abdominal wall and provides effective and safe analgesia with minimal~     systemic side effects. Their perceived benefits are thought to relate to reduced opioid~     consumption and therefore reduced opioid side effects. The investigators believe ultrasound~     guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient~     satisfaction, earlier return of bowel function and earlier hospital discharge.~      The key research question the investigators are trying to answer is whether TAP block provide~     better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both~     techniques are currently being used in our hospital and a retrospective audit demonstrated~     better analgesia and lower consumption of morphine in the TAP block group.The differences~     were not statistically significant as the number patients in the audit were not large~     enough.The investigators are hoping that this study will demonstrate that the difference is~     real by recruiting the necessary number of patients into each group (36 per group)~   "
170088|NCT01339260|"~     NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of~     netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with~     oral dexamethasone. The objective of the study is to demonstrate that netupitant and~     palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting~     induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles~     of chemotherapy.~   "
170089|NCT01339247|"~     The study is prospective, open, randomized, crossover in steady state and the volunteers~     received multiple doses of the test drug and the reference drug (two periods of drug~     administration after standardized meals).~   "
170090|NCT01339234|"~     This study is a pilot trial to evaluate the effects of supported treadmill walking in~     patients with primary progressive multiple sclerosis (MS) on functional and psychosocial~     outcomes. Patients will exercise three times per week over the course of 6 months and will be~     evaluated at baseline, 12 weeks and 24 weeks into the program. Follow-up testing will also be~     conducted 12 weeks after participants have stopped exercising to determined the lasting~     effects of the intervention.~      The investigators hypothesize that supported treadmill walking will be effective at improving~     physical physical function and psychosocial outcomes in patients with primary progressive MS.~   "
170091|NCT01339221|"~     The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian~     children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic~     drifts (point mutations) in the vaccine strain and the occurrence of genetic shifts~     (re-assortments) between vaccine and naturally circulating wild-type strains in Belgium~     population after the introduction of Rotarix™. The study will also detect if there is any~     alteration in rotavirus pathogenicity conferred by re-assortment and if the mutated vaccine~     strain is still efficacious in preventing rotavirus gastroenteritis.~   "
170092|NCT01339208|"~     The purpose of this study is to evaluate the feasibility and clinical efficacy of an~     innovative care model that combines Telemedicine consultations, educator therapeutic~     management and diabetes education to empower patients to be in greater control of their own~     diabetes care for improvements in diabetes outcomes.~   "
170093|NCT01339195|"~     Projections from epidemiological studies suggest that, among the Western adult population,~     one in three will present a cerebrovascular accident (stroke), severe cognitive disorders, or~     both. To better diagnose the Vascular Cognitive Impairment, new standards were developed by a~     North America working group which are under validation. It is essential to adapt these~     standard for French-speaking population, and especially to define cutoff scores of the~     cognitive battery to determine cognitive deficit.~      The investigators propose a study coordinated by the University-Hospital of Amiens for french~     speaking centers. This study will investigate this battery with 906 controls to define the~     standards and 302 stroke affected patients to define the frequency and cognitive mechanisms.~     This step is essential for people to benefit from these new standards.~   "
170094|NCT01339182|"~     This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of~     a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data~     for the design and conduct of subsequent studies.~   "
170112|NCT01338948|"~     The purpose of this study is to assess the feasibility of image-guided surgery in patients~     with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the~     assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance~     of will indicate the failure.~   "
170114|NCT01338922|"~     The effect of change in diabetes treatment from multiple daily insulin injection therapy to~     continuous subcutaneous insulin infusion on psychosocial outcome measures (quality of life,~     diabetes burden, parents stress level, fear, family conflicts) in families with children and~     adolescents with diabetes mellitus type 1 have been analysed. Additionally the effect on~     metabolic parameters (HbA1c, severe Hypoglycemia, Ketoacidosis) have been analysed.~   "
174229|NCT01284530|"~     Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM~     XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with~     epilepsy.~   "
170095|NCT01339169|"~     The aim of the study is to find out if the experimental medicine, YF476, can make gastric~     carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur~     mainly in patients with chronic atrophic gastritis (CAG), a condition in which the~     acid-producing cells in the lining of the stomach can't make acid. Acid production is~     controlled by gastrin, a hormone (chemical messenger) that's released into the bloodstream.~     If the stomach can't make acid, blood levels of gastrin rise. High blood levels of gastrin in~     patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow and,~     over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually benign,~     but they can become malignant. Therefore, patients with CAG and gastric carcinoids have the~     inside of their stomach checked regularly, by gastroscopy, to see if the gastric carcinoids~     need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of which is a~     mini video camera, which enables the user to inspect the lining of the stomach and a 'snare'~     to take samples of tissue (biopsies). YF476 (netazepide) is a gastrin receptor antagonist~     (blocks the effects of gastrin), so it's a potential new medical treatment for gastric~     carcinoids in patients with CAG. Up to 10 of these patients will take YF476 daily for up to~     12 weeks. If they benefit from that treatment, they may take YF476 daily for up to another 52~     weeks. They'll make several outpatient visits for tests, including checks on the safety of~     YF476. At some of the visits, they'll have a gastroscopy. At each gastroscopy, the gastric~     carcinoids will be measured and biopsies taken for laboratory tests.~   "
170096|NCT01339156|"~     P3914 a pro-drug of Naproxen, characterized by naproxen (COX inhibiting moiety) linked to a~     NO moiety is intended for the treatment of pain and inflammation. The rationale behind~     development of P3914 is to maintain the analgesic, antipyretic and anti-inflammatory activity~     of naproxen and enhance GI safety by virtue of release of NO besides with no major effect on~     blood pressure on long-term administration.~   "
170097|NCT01339143|"~     The purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to~     oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that~     was inadequately controlled by metformin.~   "
170098|NCT01339130|"~     Empathy, defined as the ability to understand others emotions, is a fundamental concept in~     social interactions. It is a psychological phenomenon involving various separable components~     : (i) the ability to feel and imagine the emotions, (ii) the ability to adopt the perspective~     of other people. Several neurological diseases with behavioral disorders may lead to impaired~     processing of social and/or emotional informations. These pathologies are likely to induce a~     lack of empathy that may result from impairments at different levels.~      The objective is simply to study how others' emotions are understood and how this allows for~     regulation of personal behavior. This study is being carried out among patients seen for~     various health problems and who can make behavior changes. This study could help to~     understand some neurological diseases and thereby to identify them earlier and/or to better~     differentiate them.~   "
170099|NCT01339117|"~     The purpose of this study is to determine whether a specific diet may help children with~     irritable bowel syndrome.~   "
170100|NCT01339104|"~     Open label Phase I study of Regorafenib to evaluate cardiovascular safety, tolerability and~     anti-tumor activity in patients with advanced solid tumors~   "
170101|NCT01339091|"~     The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy)~     of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral~     linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial~     skin or skin structure infection.~   "
170102|NCT01339078|"~     Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases.~     Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of~     choice. Problematic in this approach is the regular change, necessary to overcome occlusion~     of the stent, resulting in cholestasis and/or infection. This change needs to be performed~     every 3 months or more frequently in patients with symptoms of stent occlusion.~      The Kaffes stent (RMS) is a metallic removable stent, especially constructed for the~     treatment of biliary anastomotic strictures post liver transplantation. The advantage could~     be that this stent is less prone to occlusion with a lower change frequency (e.g. every 6~     months).~      No randomized, controlled trial (RCT) or data exist comparing plastic stenting versus Kaffes~     stenting.~   "
170103|NCT01339065|"~     . Null Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients~     undergoing elective surgery, in Mulago hospital, will not have a reduction effect on the~     levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.~      . Alternate Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult~     patients undergoing elective surgery, in Mulago hospital, will have a reduction effect on the~     levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.~   "
170104|NCT01339052|"~     BKM120 is a newly discovered drug that has been used in other research studies. Information~     from those other research studies suggests that BKM120 may help to slow or stop the growth of~     malignant gliomas. The purpose of this study is to see how well BKM120 works in patients with~     malignant gliomas. Patients on this study will be treated in two groups: patients who are~     going to receive surgery and those who will not receive surgery. This study is trying to~     determine how effective BKM120 is in stopping cancer cells from growing. For patients~     receiving surgery the research will also try to determine if an effective level of BKM120 can~     penetrate the brain before surgery.~   "
170113|NCT01338935|"~     The purpose of this study is to test the safety and efficacy of an investigational~     neuromuscular blocking agent called CW002 and to document its effects on healthy adult~     volunteers. A neuromuscular blocking agent is a drug that temporarily prevents muscles from~     moving. CW002 has not yet been approved by the Food and Drug Administration (FDA).~      Usually, neuromuscular blocking agents are used together with other drugs that put people~     completely asleep. These drugs allow doctors to place a breathing tube in the airway, stop~     muscles from moving during surgical operations, and allow ventilation (movement of air).~      This research is being done because CW002 is expected to act quickly and to provide a muscle~     block of intermediate (not too long, not too short) duration. The researchers would like to~     test increasing doses of CW002 that can be given without causing severe side effects. If~     shown to be both safe and effective, such a compound would be useful in surgical procedures~     and could improve future anesthetic care.~   "
170105|NCT01339039|"~     Plerixafor in combination with bevacizumab is a drug combination that may stop cancer cells~     from growing abnormally. Bevacizumab, also known as Avastin, is FDA approved for use in~     patients with recurrent glioblastoma and has been studied extensively in other types of solid~     tumors. Plerixafor, also known as Mozobil, is FDA approved for use in patients with~     non-Hodgkin's lymphoma and multiple myeloma and has been used in treatment for other cancers.~     Information from experiments in laboratories suggests that the combination of plerixafor and~     bevacizumab may help prevent the growth of gliomas.~      Part 1: The investigators are looking for the highest dose of plerixafor that can be given~     safely with bevacizumab (with a 21 days on/7 days off regimen of plerixafor). The~     investigators will also do blood tests to find out how the body uses and breaks down the drug~     combination.~      Part 2: The investigators are looking to see if plerixafor can get past the blood-brain~     barrier and into brain tumors. The investigators will also do blood tests to find out how the~     body uses and breaks down the drug combination.~      Part 3: The investigators are looking for for more information re: safety and tolerability of~     plerixafor in combination with bevacizumab (with a 28 days on/0 days off regimen of~     plerixafor). The investigators will also do blood tests to find out how the body uses and~     breaks down the drug combination.~   "
170106|NCT01339026|"~     Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle~     (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ± stent~     procedure, which restores blood flow to the heart. Antiplatelet drugs (Aspirin and~     Clopidogrel) are blood thinning treatments and research has reported they reduce heart~     attacks, death and stroke. The investigators know some patients do not respond fully to~     Clopidogrel but currently patients are not tested for this.~      The investigators wish to perform a trial to identify those patients who do not respond fully~     to Clopidogrel and randomise them to either Prasugrel (newer drug) or a higher dose of~     Clopidogrel.~      Patients admitted to the hospitals (2 in the UK and 1 in Germany) will be asked for their~     consent to participate. A blood sample is tested for platelet activity.~        1. Low platelet activity result means patient has responded well to Clopidogrel and will~          continue on the routine dose. They will be entered into an observational registry. Data~          will be collected of routine blood tests and investigations, medication and procedures.~          Their GP will be contacted at about 30 days to see if they are alive.~        2. High platelet activity results means patient has not responded fully to Clopidogrel.~          These patients will be randomly allocated to a higher dose of Clopidogrel or new drug~          Prasugrel. Data will be collected of routine blood tests and investigations, medication~          and procedures. A hospital visit at 30±5 days is required to assess how patients are~          doing, medications and occurrence of any events.~   "
170107|NCT01339013|"~     The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon~     which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs~     and must be compensated for by increased ventilation. This study aims at determining how much~     compensation must be given, based on the hypothesis that rebreathing depends on carbon~     dioxide level in blood and exhaled air.~   "
170108|NCT01339000|"~     Background: Drugs given to treat cancer (chemotherapy) can weaken the human immune system.~     But it can also become weaker because of aging. Interleukin (IL)-7, a molecule produced~     naturally in the body, can help improve the function of the immune system. Researchers want~     to study the effects of IL-7 on immune system function in two different groups of older~     people. One group will be people who have received vaccines before IL-7. The other group will~     be people who have received Vaccines after IL-7.~      Objectives: To evaluate the effect of IL-7 on the immune system responses to vaccines in~     older people following chemotherapy.~      Eligibility: People at least 60 years of age who have recently finished chemotherapy for~     breast, colon, or bladder cancer.~      Design:~        -  People in the study will be screened with a physical examination, medical history, and~          blood tests. Other screening tests, such as tumor imaging, may also need to be~          performed.~        -  Everyone will receive a series of five different vaccines commonly used to prevent~          diseases. We will compare the responses of people in Sequence 1 who will receive~          vaccines before IL-7 with the responses of people in Sequence 2 who received the same~          vaccines after IL-7.~        -  The vaccines will be given randomly in two Arms at different times.~             -  Arm 1: diphtheria and tetanus, polio, pneumonia (with two booster shots), hepatitis~               B (with two booster shots), and hepatitis A (with one booster shot),~             -  Arm 2: hepatitis A (with one booster shot), hepatitis B (with two booster shots),~               pneumococcal (with two booster shots), diphtheria and tetanus, polio, pneumonia~               (with two booster shots)~        -  There are 5 vaccines to be given to each subject, following one of two randomly assigned~          sequences of vaccine administration (Sequence 1 or Sequence 2).~        -  The first vaccine arm contains the two diphtheria protein containing vaccines tetanus~          and diphtheria (Td) and pneumococcal conjugate 13 (PCV13) and polio. The second vaccine~          arm contains the Hepatitis A and Hepatitis B vaccines. Subjects will either get tetanus,~          diphtheria, polio, and pneumonia vaccines before IL-7 therapy (Sequence 1) or hepatitis~          A and hepatitis B vaccines before IL-7 therapy (Sequence 2). The response to vaccines~          will be evaluated 4 weeks after vaccination. This will be followed by IL-7 therapy, then~          administration of the other group of vaccines. Therefore, subjects on both arms will~          receive the same set of vaccines, just at different times with respect to IL-7 therapy.~   "
170109|NCT01338987|"~     Background:~        -  One way to treat certain cancers of the blood and immune system is to give a patient~          stem cells from the bone marrow of a donor whose genes are very similar but not~          identical to the patient s. One problem with these transplants is that the new immune~          cells may not work as well in the recipient as they did in the donor. The result may be~          that the immune system will not work as well. This can increase the risk of severe~          infections and other complications.~        -  Researchers are studying the use of drugs that lower hormone levels and may allow the~          immune system to recover in a way that improves white blood cell function. In this study~          they will be looking at the drug lupron, a drug that lowers estrogen or testosterone~          levels, to see if it might improve the function of the newly transplanted cells.~      Objectives:~        -  To determine whether lupron improves immune system function after bone marrow~          transplantation from a donor with similarities in their immune cells (matched to each~          other).~        -  To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug FLT in~          imaging studies. FLT will be used to image the immune system function in patients who~          have received bone marrow from the donor.~      Eligibility:~        -  People between 15 (or as young as 9 in those who have gone through puberty) and 40 years~          of age. These patients must have acute myelogenous leukemia, acute lymphocytic leukemia,~          or high-risk myelodysplastic syndrome. They must also be eligible for a bone marrow~          transplant.~        -  Genetically similar donors for the patients who are eligible for a transplant.~      Design:~        -  People taking part in the study will be screened with a physical examination, medical~          history, blood and urine tests, and imaging studies. Patients who are not in remission~          or who require a bone marrow donor search may receive chemotherapy first.~        -  Donors will provide bone marrow for transplant according to standard bone marrow~          transplant (BMT) procedures.~        -  All women and half of the men will receive regular lupron doses 2 weeks before BMT to~          suppress hormone function.~        -  All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy~          before the bone marrow transplant (depending on age). Recipients will also receive other~          drugs to prevent transplant rejection and other complications of transplantation.~        -  Recipients will be monitored in the hospital for 4 weeks after transplant with blood~          tests and other studies.~        -  Some recipients will have an imaging study with FLT during the protocol. These imaging~          studies will take place before the transplant, on days 5 and 28 after transplant, and at~          a later time to be determined by the study researchers.~        -  Following discharge, participants will be monitored closely for up to 6 months, with~          regular but less frequent followup visits for at least 5 years. Study-related~          medications, including vaccinations for the new immune system, will be provided by the~          National Institutes of Health during the hospital stay and after discharge.~   "
170110|NCT01338974|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer treated with~     cytarabine in the laboratory may help doctors learn more about the effects of cytarabine on~     cells. It may also help doctors understand how well patients respond to treatment.~      PURPOSE: This research trial studies biomarkers associated with response to cytarabine in~     samples from older patients with acute myeloid leukemia.~   "
170127|NCT01338753|"~     The purpose of this study is to compare the association between image and certain molecular~     markers with complete response in patients with locally advanced breast cancer, treated with~     neoadjuvant chemotherapy composed of Bevacizumab, Docetaxel and Doxorubicin.~   "
170115|NCT01338909|"~     This is a single-center, randomized, single-blind, investigator-initiated, pharmacological~     study with a parallel design. Patients with ST elevation myocardial infarction undergoing~     primary percutaneous coronary intervention and presenting high platelet reactivity as~     assessed with the Verify Now P2Y12 assay-Accumetrics(Platelet Reactivity Units -PRU≥235) at 2~     hours post-clopidogrel 600mg LD (Day 0), as assessed with the Verify Now P2Y12 assay, will be~     randomized after informed consent, in a 1:1 ratio to the following treatment groups:~      Group Α: Clopidogrel 150mg per day,starting from Day 1 until Day 5 (5 days after~     randomization) Group Β: Prasugrel 60 mg immediate loading (on Day 0) followed by 10mg/day~     starting from Day 1 until Day 5 (5 days after randomization).~      Platelet reactivity assessment will be performed 2 hours after randomization (Day 0), 24 h~     after randomization (Day 1) and on Day 5. Documentation of major adverse cardiac events~     (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and~     serious adverse events (bleeding, other adverse events)will be performed until Day 5.~   "
170116|NCT01338896|"~     The primary objective of the study is to compare the adhesiveness of two different patch~     formulations of rotigotine using patch size 40 cm2, under the assumption that both patch~     formulations show similar adhesiveness properties.~   "
170117|NCT01338883|"~     This is a randomized, double-blind, double-dummy, 48-week, comparative study. Approximately~     150 HIV-infected, treatment-naïve patients with CCR5-tropic virus will be stratified by HIV-1~     RNA: ≥100,000 copies/mL versus <100,000 copies/mL and will be randomized 2:2:1 to receive:~        -  Arm A: CVC 100 mg (2 tablets, 50 mg each) QD + CVC matching placebo (2 tablets) QD + EFV~          matching placebo (1 tablet) QHS + FTC/TDF (1 tablet) QD.~        -  Arm B: CVC 200 mg (4 tablets, 50 mg each) QD + EFV matching placebo (1 tablet) QHS +~          FTC/TDF (1 tablet) QD.~        -  Arm C: CVC matching placebo (4 tablets) QD + EFV 600 mg (1 tablet) QHS + FTC/TDF (1~          tablet) QD.~      Doses of both CVC/placebo and EFV/ placebo will be administered as double-blinded study drug.~     FTC/TDF will be administered as open-label study drug in a fixed-dose combination formulation~     (Truvada). CVC/placebo should be taken following breakfast; EFV should be taken on an empty~     stomach at bedtime.~      HIV-1 RNA levels and CD4+ and CD8+ cell counts, percentages, and ratios will be measured at~     every visit. Samples for viral tropism and resistance testing in case of virologic failure~     will be collected at Screening and each on-treatment visit.~      Biomarkers associated with inflammation and immune activation will be measured at Baseline~     (predose) and each study visit thereafter, with flow cytometry obtained at weeks 4, 12, 24,~     48, and 52.~      Fasting metabolic indicators of glucose control (glucose and insulin for HOMA-IR, HbA1c) and~     fasting lipid profiles (HDL, LDL, total cholesterol, and triglycerides) will be measured at~     Baseline (predose) and Weeks 4, 12, 24, 48, and 52. Waist-to-hip ratios will be measured at~     Baseline and Weeks 24 and 48.~      Plasma samples will be collected and stored for possible future studies at Baseline (predose)~     and every visit thereafter.~   "
170118|NCT01338870|"~     B2611003 is designed to study how safe and effective an investigational medication~     (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6~     treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug,~     and another treatment will be placebo, which does not contain active ingredient.~   "
170119|NCT01338857|"~     The purpose of this study is to determine if a drug called sorafenib can shrink LGA tumors~     (low-grade astrocytomas) in children and adults. Previous research has given us a better~     understanding of this type of tumor by studying the genetic make-up of LGAs. From this~     research, the investigators found that a drug called sorafenib may stop the growth of tumor~     cells by blocking some of the molecules needed for cell growth and by blocking blood flow to~     the tumor. This trial is studying how well sorafenib works in treating patients with LGAs,~     and how the effects relate to the specific genetic make-up of your particular tumor. This~     testing of your tumor's genetic make-up is optional and requires available tumor tissue for~     testing. In summary, the aims of this study are: To see if sorafenib can shrink LGAs; how~     well sorafenib is tolerated in patients with LGAs; and, how the effects of sorafenib relate~     to the genetic make-up of individual LGAs (Optional Study)~   "
170120|NCT01338844|"~     Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various~     stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted~     Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).~      The hormonal control of multiple follicular growth and maturation is a critical part of ART~     procedures since it maximizes the yield of embryos to be transferred, thus increasing the~     cumulative pregnancy rate.~      Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and~     highly effective treatment in order to improve oocyte quality in patients undergoing IVF.~     Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable~     predictor of oocyte quality. High MI concentration in the FF directly correlates with high~     oocyte and embryo quality.~      Another stereoisomer of Inositol was successfully used into clinical practice~     D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in~     hyperglycemic PCOS patients.~      In the present study we aim to compare MI versus DCI supplementation on oocyte quality of~     women undergoing IVF-ET~   "
170121|NCT01338831|"~     The purpose of this first multi-dose study in cancer patients is to determine the maximum~     tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety,~     tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D~     chosen, the study will enroll patients into the expansion portion of the study.~   "
170122|NCT01338818|"~     This study will evaluate the long-term safety of methylphenidate hydrochloride extended~     release in adults with attention deficit/hyperactivity disorder~   "
170123|NCT01338805|"~     This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as~     adjunctive treatment in patients with partial onset seizures.~   "
170124|NCT01338792|"~     This phase II trial studies how well giving oxaliplatin and pemetrexed disodium together~     works in treating patients with refractory hormone-resistant prostate cancer. Drugs used in~     chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     oxaliplatin together with pemetrexed disodium may kill more tumor cells.~   "
170125|NCT01338779|"~     The purpose of this multi-center (observational) registry study is to establish a database of~     clinical and laboratory information that may help to identify any unique characteristics of~     tolerant participants that differ from participants who reject their kidney after~     discontinuing immunosuppressive drugs.~   "
170126|NCT01338766|"~     The purpose of this study is to evaluate the clinical performance of a decompression using~     the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable~     grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55%~     positive response rate.~   "
170128|NCT01338740|"~     Switching to Adalimumab has proven to be efficacious in Crohn's disease (CD) patients with~     intolerance or loss of response to Infliximab. Currently there are no studies on the efficacy~     of switching to Infliximab in patients with loss of response or primary non-response to~     Adalimumab. Even in rheumatology, where switching between all classes of anti-TNFα~     biologicals is common practice, there are no scientific data on switching from humanized to~     chimeric anti-TNFα antibodies.~      The purpose of this study is to document the efficacy of such a switch and to identify the~     possible predictive factors for success.~      If treatment with Adalimumab fails (despite optimal dose and interval) and the treating~     physician therefore decided to switch to infliximab, the patient may be enrolled in this~     observational study. At regular intervals (every Remicade), the patient will be clinically~     re-evaluated. The disease activity score will be calculated: Crohn's disease activity index~     (CDAI). At regular intervals, the results of interim blood tests will be documented (3x). The~     succession will be 1 year. At week 10, 26 and 52, additional serum samples will be taken for~     determination of antibodies against Adalimumab and Infliximab. The serum levels of Adalimumab~     (week 0) and Infliximab (week 10, 26 and 52) will be determined.~      For this study there is no specific therapy change. The study wants only to document the~     results of a therapy switch that, in current clinical practice, is made by the treating~     physician.~   "
170129|NCT01338727|"~     The primary objective of this study is to evaluate the efficacy of a specialized exclusive~     breastfeeding education and support program targeting obese, pregnant, low-income women in~     Hartford, CT. Specifically, the investigators will evaluate the impact of the intervention on~     exclusive and partial breastfeeding rates at birth, 1, 3 and 6 months pp. Secondary aims of~     this study are: a) to characterize postpartum weight loss patterns and blood pressure values~     of obese women, by study group; and b) to evaluate potential differences in infant morbidity~     (diarrhea, otitis media and rehospitalization), by study group.~   "
170130|NCT01338714|"~     The aim of the study is to examine whether the compound herbal formula (RHD-1) is effective~     on HBV Carrier With Abnormal Liver Function.~   "
170131|NCT01338701|"~     This study investigates whether acupuncture can help to decrease the number and severity of~     headaches in people who have Traumatic Brain Injury. The aim of this study is to compare two~     different types of acupuncture—either Traditional Chinese Acupuncture or ear acupuncture—to a~     group that receives no acupuncture at all. Acupuncture has been demonstrated to reduce pain,~     improve health-related quality of life, prevent migraine headaches, and improve tension and~     chronic daily headaches.~   "
170132|NCT01338688|"~     The investigators want to determine whether TIG influences the formation of tetanus antibody~     after simultaneous tetanus vaccination according to age and the time-interval of the last~     tetanus vaccination.~   "
170133|NCT01338675|"~     In this study the investigators plan to use optimal busulfan dose through pharmacokinetic~     study in stem cell transplantation of CGD patients.~   "
170134|NCT01338662|"~     The purpose of this study is to compare the onset time and severity of dyskinesia in~     amantadine or Dopamine agonist initial treated groups in Parkinson`s disease.~   "
170135|NCT01338649|"~     Study objectives are to determine the efficacy, safety and tolerability of bright light~     treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients~     will be enrolled and equally randomized to bright light or dim-red light treatment. Objective~     (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the~     baseline and intervention phases of the study. The primary outcome measure will be the change~     in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment with dim-red light~     treatment. Secondary outcome measures will include the Multiple Sleep Latency Test (MSLT),~     global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease Sleep Scale (PDSS)~     score, and actigraphy measures. A variety of exploratory analyses will examine the effects of~     bright light treatment on fatigue, depression, quality of life, cognition, and motor~     disability.~      Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time~     sleep in PD patients with daytime sleepiness.~   "
170136|NCT01338636|"~     The purpose of this study is assess whether ambrisentan can help people with exercise-~     induced pulmonary arterial hypertension (EIPAH). The investigators also want to find out if~     ambrisentan is safe to take without causing excessive side effects.~   "
170137|NCT01338623|"~     The purpose of this study is to compare the bioavailability (rate and extent of absorption)~     of two tansulosine 0,4 mg capsule formulations. An open, randomized, two-period crossover~     study with a seven-days washout interval was conduced in 32 healthy male volunteers. The~     plasma samples were obtained up to 72 hours after drug administration. A sensitive and~     specific LC-MS/MS method was developed and validated for the determination of tansulosine in~     human plasma. Bioequivalence between the products was determined by calculating 90%~     confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.~   "
170138|NCT01338610|"~     The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing~     the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale~     (VAS) discomfort score.~   "
170139|NCT01338597|"~     The purpose of this study is to investigate whether reduced subcutaneous dissection area~     could offer patients more clinical benefits.~   "
170159|NCT01338337|"~     Primary Outcome Measures:~      • To evaluate the efficacy of treatment with Azacitidine in patients with~     transfusion-dependent, low risk International Prognostic Scoring System (IPSS) 0 int-1,~     Myelodysplastic Syndrome (MDS) without chromosome 5 (5q) deletion. The main objective will be~     based on the erythroid haematologic response according to International Working Group (IWG)~     2006 criteria.~      Secondary Outcome Measures:~        -  Haematologic response, bases on the following parameters: platelets, and neutrophils~          according to International Working Group (IWG) Criteria.~        -  Medullary and cytogenetic response according to International Working Group (IWG) 2006~          criteria.~        -  The effect of treatment response on quality of life, through the Functional Assessment~          of Cancer Therapy-Anemia (FACT-an) questionnaire.~        -  Overall survival, Event-Free Survival and the Acute Leukaemia Transformation Rate.~   "
170543|NCT01333137|"~     P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T~     inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer~     cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of~     gemcitabine and carboplatin when administered with or without P276-00 in subjects with~     advanced triple negative breast cancer.~   "
170140|NCT01338584|"~     Urinary incontinence after radical prostatectomy is a significant clinical problem despite~     advances in surgical techniques. In the literature, the incidence of post prostatectomy~     urinary incontinence varies widely from 0.5 to 87% (Parekh et al, 2003). Various reasons are~     held responsible for this wide discrepancy, including surgical technique, definition of~     incontinence, time of evaluation, pathological stage, and patient age. The etiology of post~     prostatectomy urinary incontinence has been attributed to sphincteric deficiency, either from~     injury of striated muscle fibres or the innervating nerve fibres (Koelbl et al 2002). The~     effect of urinary incontinence on the quality of life in these patients has been subject to~     debate (Litwin et al, 1995; Braslis et al, 1995). For many patients, however, early recovery~     from urinary incontinence has been a major concern (Moore et al, 1999), especially in younger~     patients.~      Various treatment modalities for post prostatectomy urinary incontinence have been~     introduced, including conservative managemnt such as pelvic floor muscle training,~     pharmacological treatment and surgical treatment. However, surgery is an invasive procedure~     and it's usually be the last resort. Although the Cochrane Incontinence Group (2007)~     commented on the need for ongoing research to clarify the role of pelvic floor muscle~     training, it is still the first-line treatment used to restore pelvic floor or bladder~     function after radical prostatectomy (MacDonald et. al., 2007). Currently, patients learned~     pelvic floor muscle training on the day of admission for surgery by ward staff in HA~     hospitals of Hong Kong. Subsequently, after removal of urethral catheter, patients will~     attend the nurse-led clinic for reassessment and reinforcement of pelvic floor muscle~     training. The continence rates which defined as zero pad were 69%, 78.7% and 88.9% at 3~     months, 6 months and 12 months respectively (Tam and Ho et al., 2010). In order to determine~     the efficacy of intensive preoperative pelvic floor muscle training to decrease~     post-prostatectomy urinary incontinence, a randomized controlled trial will be conducted.~     Participants in the intervention group would start the pelvic floor muscle training 3 weeks~     before surgery provided by an urology nurse specialist whereas the control group would start~     the pelvic floor muscle training on the day of admission for surgery provided by ward staff.~     Measurement on the grams of urine loss, sense of self control in urination and quality of~     life are collected on 4, 8, 12 and 24 weeks after surgery for comparison between the two~     groups.~   "
170141|NCT01338571|"~     This is a pilot study and will be used to power an NIH grant application on the effect of~     resistant starch on weight gain in children.~   "
170142|NCT01338558|"~     This randomized, open-label study will evaluate the safety and efficacy of Avastin~     (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage~     IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be~     assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each~     2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in~     addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease~     progression or unacceptable toxicity occurs.~   "
170143|NCT01338545|"~     This observational study will evaluate the dosage patterns, safety and efficacy of~     RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe~     rheumatoid arthritis who have not responded or are intolerant to at least one~     disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from~     each patients for 12 months.~   "
170144|NCT01338532|"~     The purpose of this study is to evaluate the time to total hip replacement in patients with~     hip osteoarthritis going through both a supervised exercise program and patient education~     compared to patients going through patient education only.~      The null hypothesis is: There are no differences in time to total hip replacement between~     patients with hip osteoarthritis who went through a 12 week supervised exercise program and~     patient education compared to patients who went through patient education only.~      Material and methods:~      109 patients with both symptomatically and radiographically verified hip osteoarthritis were~     included in this randomized controlled trial between april 2005 and october 2007. They were~     randomized to either a 12 week supervised exercise program and patient education (n=55) or~     patient education only (n=54).~      Information on if and when total hip replacement is performed will be collected between April~     1st and May 1st. Time since inclusion to follow-up will range from 3.5 to 6 years. Data will~     be collected directly from the study participants by telephone.~      The main outcome is time to total hip replacement.~      Status:~      This study is a prolongation of an on-going RCT (3a-2005-NAR) using clinical outcomes to~     evaluate the effect of supervised exercise and patient education.~      The study will be carried out: NAR-Department of Orthopedics, Ullevaal University Hospital.~   "
170145|NCT01338519|"~     All newly referred patients with PCOS and hirsutism are listed in a database.~   "
170146|NCT01338506|"~     In comparison to the general population, U.S. military and Veterans are at an increased risk~     for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD).~     Current research has shown that there is a high comorbidity of SUD and PTSD, and although~     there are a number of treatments for SUD and PTSD independently, there are very few effective~     methods to simultaneously treat both disorders. Because of this substantial gap in the~     treatment of both SUDs and PTSD, it has become essential to develop a combined treatment that~     would address and treat both disorders. Individuals, specifically U.S. military and Veterans,~     with SUD/PTSD have unique needs that require a specialized treatment approach. This designed~     approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in conjunction~     with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an empirically~     supported and evidence-based treatment that is currently regarded as the gold standard~     psychosocial treatment for PTSD. In combination with CBT, this treatment would address both~     disorders in hopes of reducing substance use and PTSD symptomatology.~   "
170147|NCT01338493|"~     The primary purpose of the study is to document the reduction of disability after Maverick~     total disc replacement surgery in a 'real-world' patient population requiring disc~     replacement.~   "
170148|NCT01338480|"~     This study is planning to develop the audiovisual videos and determine whether educational~     videos are superior to routine discussion for informing trauma patients in emergency~     department (ED) about risks, benefits, and alternatives to receiving surgery.~   "
170149|NCT01338467|"~     The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment~     using High Intensity Focused Ultrasound in refractory glaucoma patients.~   "
170160|NCT01338324|"~     The small bowel biopsy is the cornerstone of for the diagnosis of celiac disease. In addition~     to being the gold standard for the initial diagnosis of celiac disease, periodic biopsies are~     also recommended on an ongoing basis for this life-long disease. However, biopsy evaluation~     is invasive and expensive. Therefore, there is a need for simple, non-invasive tests that can~     be performed on celiac patients with subclinical disease.~      The present study is based on the hypothesis that the expression and activity of cytochrome~     P450 CYP3A4 in the small intestinal mucosa is a sensitive measure of enteropathy. Therefore~     small intestinal CYP3A4 activity will be markedly different in celiac disease patients with~     active disease as compared to patients in remission. Small intestinal CYP3A4 activity will be~     measured in three ways:~      (i) Cmax of oral simvastatin, a widely used drug that is predominantly metabolized by small~     intestinal CYP3A4; (ii) AUC of oral simvastatin; and (iii) Measurement of CYP3A4 activity in~     two small bowel biopsies.~   "
170150|NCT01338454|"~     Obstetrical hemorrhage accounts for nearly one quarter of all maternal deaths worldwide and~     was the most common cause of maternal death in the Turkey [1,2]. Most of these deaths occur~     within 4 h of delivery and are a result of problems during third and fourth stages of labor.~     It also contributes significantly to serious maternal morbidity. Obstetric, surgical and~     radiological interventions play central role in the management of obstetric hemorrhage;~     however, pharmacologic management and in particular prohemostatic therapies also play an~     important role in the final maternal outcome. Administration of tranexamic acid (TA),~     intravenously in the third stage of labor may be one of these methods.~      TA a synthetic derivate of the amino acid lysine, is an antifibrinolytic that reversibly~     inhibits the activation of plasminogen, thus inhibiting fibrinolysis and reducing bleeding.~     TA may enhance the effectiveness of the patient's own hemostatic mechanism [3,4]. In~     nonobstetric surgery, a systematic review of randomized controlled trails showed that~     tranexamic acid reduced the risk of blood transfusion [ relative risk (RR) 0.61; 95% CI~     0.54-0.69] and also reduced the need for re-operation as a result of bleeding (RR 0.67; 95%~     CI 0.41-1.09). There was no evidence for an increased risk of thrombotic events [5].~      In gynecology and obstetrics, TA is most commonly used to treat idiopathic menorrhagia, and~     is an effective and well-tolerated treatment when administered orally [5,6,7]. Bleeding~     associated with pregnancy (placental abruption, placenta previa) has also been treated with~     TA [6]. Furthermore, four randomized controlled studies have shown that TA reduces postpartum~     hemorrhage (PPH) following cesarean delivery [7-11]. Only one randomized trail is available~     evaluating the effect of TA use to prevent bleeding in the postpartum period following~     spontaneous vaginal delivery [12].~      The purpose of our study was to estimate the effect of the addition of intravenous TA to a~     standard active management of the third stage of labor (which includes prophylactic injection~     of 10 IU of oxytocin within two minutes of birth, early clamping of the umbilical cord, and~     controlled cord traction).~   "
170151|NCT01338441|"~     The study main objective is to assess the changes in the ventricular repolarization (measure~     by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify~     subjects with extreme responses and collecting their skin and blood samples.~   "
170152|NCT01338428|"~     More than one in six women will be sexually assaulted in their lifetimes, most by men they~     know. The risk of sexual assault by men is greatest for girls and women between the ages of~     14 and 24 making this a critical time for intervention. Sexual assault has many immediate and~     long-term negative consequences for victims. Even a small increase in the ability of women to~     resist sexual assault will result in a substantial improvement in the mental and physical~     health of women. Recent research has suggested that many young women delay their resistance~     to unwanted sexual advances because they are not sure that they are reading the situation~     correctly, they do not want to hurt the man's feelings, or they are unsure whether they have~     the right to say no to some sexual activity and say yes to other activity. Earlier work from~     the researchers resulted in the development of a program affecting these critical areas. This~     program was shown to be effective in helping participants build skills and a knowledge base~     to help them resist sexual assault and to prepare them for better recovery following sexual~     assault. The randomized controlled trial (RCT) builds on this prior work. We will establish~     whether the demonstrated short term effectiveness of this theoretically and empirically sound~     rape resistance intervention for university women extends to longer periods. We will~     determine whether the program can reduce the one year incidence of sexual assault by 30%~     among women attending Canadian universities. The results will also be used to indicate how~     long the effects of the program last and will indicate at which point in time refresher~     sessions may be necessary. A lay summary of the findings of the trial with a focus on~     application will be provided to all Canadian universities and to Provincial/Territorial~     Ministries of Education. This will be followed up with contact with those most likely to be~     involved in current campus education efforts.~   "
170153|NCT01338415|"~     The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety,~     tolerability and efficacy of the pediatric formulation of bosentan two versus three times a~     day in children with Pulmonary Arterial Hypertension (PAH).~   "
170154|NCT01338402|"~     The purpose of this study was to assess the ocular response to and performance of the~     cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK®~     COLORBLENDS.~   "
170155|NCT01338389|"~     Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable~     results in causing tumor regression while preserving the eye. Optic neuropathy has emerged~     consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No~     neuroprotective strategies are available at present.~      Citicoline is a choline agent precursor available as a dietary supplement. Citicoline~     conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models.~     In ophthalmology, citicoline has demonstrated a significant action in improving retinal and~     cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic~     neuropathy). Citicoline also exhibits a very low toxicity profile in humans.~      The purpose of the study is to demonstrate whether daily oral administration of citicoline in~     patients treated for uveal melanomas with proton beam therapy, prevents or delays the~     occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual~     evoked potentials are measured. The tolerability/safety of the product is also evaluated.~   "
170156|NCT01338376|"~     Diabetes is a common, costly condition associated with significant morbidity and mortality.~     Diabetes self-management education, the process of teaching individuals to manage their~     diabetes, has been considered an important part. The intensive education has the capacity to~     deliver effective interventions to a large number of people. The investigators may be able to~     redirect our efforts to diabetes care and education strategies that will have a positive~     impact on the optimization of glycemic control and the prevention of long-term complications~     of diabetes, reducing the subsequent human and health care costs.~   "
170157|NCT01338363|"~     The purpose of this study is~        1. To describe patient characteristics and drug usage among children that are prescribed~          esomeprazole for the first time and to compare them with patients who are prescribed~          other proton pump inhibitors (PPIs) or H2-receptor antagonists for the first time.~        2. To ascertain all incident hospitalized cases of angioneurotic oedema, pneumonia,~          gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis~          and thrombocytopenia among new users in the three cohorts of esomeprazole, other PPIs~          and H2-receptor antagonists.~   "
170158|NCT01338350|"~     The purpose of this study is to assess safety, tolerability, pharmacokinetics and~     pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and~     post ACTH stimulation, dehydroepiandrosterone sulphate (DHEAS), osteocalcin and 24 hours~     urine cortisol) of AZD5423 following administration of single and multiple ascending doses in~     healthy male Japanese subjects.~   "
170161|NCT01338311|"~     Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness~     (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the~     long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The~     onset of tolerance to salbutamol is not known.~   "
170398|NCT01335035|"~     This study has been designed to establish the efficacy and safety of deferasirox in patients~     with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant~     (HSCT).~      The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of~     treatment with deferasirox, in patients with iron overload (defined with serum ferritin~     levels ≥ 1000 ng/ml and receiving > 20 RBC concentrates) after allogeneic HSCT.~   "
170162|NCT01338298|"~     Prolactin is a hormone that naturally occurs in the body. Some women taking antipsychotic~     medications may have high levels of prolactin in their bodies. High levels of prolactin may~     cause women to have problems with sex or satisfaction from sex. It may also cause women to~     have fewer or no menstrual periods. It may also cause the production of breast milk and may~     contribute to long term bone loss.~      In this study, the investigators are testing whether taking adding a low dose of an~     antipsychotic medication called aripiprazole may help improve high prolactin levels and help~     with sexual dysfunction or problems with menstrual periods. The investigators are also~     looking to see if it may slow the loss of bones. This medication has been shown to be helpful~     for improving symptoms of schizophrenia.~   "
170163|NCT01338285|"~     Background:~        -  Research suggests that occupational exposure to formaldehyde is associated with~          increased risk for myeloid leukemia, but the significance of these findings is uncertain~          because of inconsistencies among studies and lack of knowledge of how formaldehyde can~          cause leukemia.~        -  Damage to the DNA of myeloid cells (type of white blood cell) or an environmental factor~          not affecting the cell genetic machinery may be involved.~      Objective: To determine if formaldehyde exposure is associated with genetic or other changes~     in myeloid cells.~      Eligibility: Workers exposed to high levels of formaldehyde and unexposed workers in~     Guangdong Province, China.~      Design:~        -  40 exposed workers and 40 unexposed workers will be enrolled.~        -  Subjects wear small instruments at work that measure chemicals in the air for 1 or 2~          days.~        -  Subjects have a brief physical examination and provide blood, urine, and mouth rinse~          samples.~        -  Subjects answer a questionnaire about work, smoking and drinking, use of medicines,~          medical history, general health, exposure to radiation and exposure to various~          substances at home.~   "
170164|NCT01338142|"~     The study objective is, to evaluate the fractional absorption of calcium from amorphous~     calcium carbonate (ACC) Vs crystalline calcium carbonate (CCC) dietary supplements in~     postmenopausal women.~   "
170165|NCT01338129|"~     The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome~     (CRPS)~   "
170166|NCT01338116|"~     Severe bacterial infections are associated with mortality of about 30%. Patients with~     moderate to severe bacterial infections given early and appropriate empirical antibiotic~     treatment are at a lesser risk for a fatal outcome, with odds ratios ranging from 1.6 to 6.9.~     However only about 2/3 of patients worldwide are given early and appropriate empirical~     antibiotic treatment. About 40% of patients treated with antibiotics are given superfluous~     treatment.~      TREAT is a computerized decision support system for antibiotic treatment in inpatients with~     common bacterial infections. TREAT is based on a state of the art stochastic model of the~     domain (a causal probabilistic network) and uses a cost benefit model for antibiotic~     treatment, including costs assigned to future resistance. It was tested in a randomized~     controlled trial in 3 countries and shown to improve the percentage of appropriate empirical~     antibiotic treatment while at the same time reduce hospital stay and the use of~     broad-spectrum antibiotics. The main limitation of TREAT is inherent in the limited~     information available within hours of presentation.~      A second attractive approach to improve antibiotic treatment is to use techniques that do not~     depend on cultures, and thus shorten the time to identification of the pathogen to a few~     hours only. The LightCycler® SeptiFast test from Roche performs in vitro nucleic acid~     amplification test for pathogens causing bloodstream infections.~      The purpose of the clinical trial is to show that the combined system TREAT/PCR assays will~     improve the outcome of inpatients with moderate to severe bacterial infections, while at the~     same time reducing the use of broad-spectrum antibiotics, with no or little additional costs.~     A secondary objective will be to assess the sensitivity and specificity of whole blood PCR,~     using TREAT as the reference standard.~   "
170167|NCT01338103|"~     The purpose of this study is to determine whether Rituximab, in the same doses as used in~     rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function~     via the Cylex assay in pemphigus patients before and after treatment with RItuximab.~   "
170168|NCT01338090|"~     This is a pilot study for evaluation of 89Zr-bevacizumab PET imaging as predictive biomarker~     during treatment with everolimus in patients with neuroendocrine tumors.~      Patients with progressive disease during the last year will receive treatment with everolimus~     10 mg/day orally and 89Zr-bevacizumab PET imaging will be performed before start of treatment~     and after 2 and 12 weeks of treatment in the first three patients. If the scan after 2 weeks~     of treatment is already informative further patients will not undergo a scan at 12 weeks. A~     scan is considered already informative if both scans show at least 30% decrease in uptake in~     case of response, or at least 30% increase in uptake in case of disease progression.~      Four days before the scan patients will be injected intravenously 37 MBq, protein dose 5 mg~     89Zr-bevacizumab. At day 1, day 15 and day 99, PET images will be made for visualization and~     quantification of VEGF in the tumor lesions and blood will be drawn for determination of~     angiogenesis and mTOR pathway related biomarkers.~   "
170169|NCT01338077|"~     About 60% of patients with typical gastroesophageal reflux symptoms such as heartburn and~     regurgitation are considered to have non-erosive reflux disease (NERD). Patients with NERD~     show an overall poorer response to PPI treatment than patients with erosive reflux disease.~     Sodium alginate oral suspension is a medication indicated for the relief of gastroesophageal~     reflux symptoms. This multi-center, double blind, randomized trial aims to compare the~     efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times~     daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of NERD~     patients in Taiwan. Efficacy assessments include percentage of patients achieving adequate~     relief of heartburn or regurgitation after 4 weeks treatment, improvement of reflux symptoms~     as assessed by reflux disease questionnaire before and after treatment, and patients overall~     satisfaction at the end of study. Safety assessments include incidence of adverse events and~     change of the laboratory test results. The study hypothesis is that treatment with sodium~     alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of~     the NERD patients.~   "
170170|NCT01338064|"~     Silicosis is well-known occupational disease caused by free crystalline silica (silicon~     dioxide) and is marked by inflammation and pulmonary fibrosis. There are cumulative evidences~     that exposure to Caesar stone (quartz surface products that manufactured from up to 93%~     quartz, polymer resins and pigments) is particularly dangerous to exposed workers.~      Goals: To examine marble workers exposed to Caesar Stone in order to propose a working plan~     of surveillance and prevention by biological monitoring.~   "
170171|NCT01338051|"~     This project will use a community based participatory research orientation to develop a model~     for large scale campaign preventive healthcare interventions. The investigators have~     considerable expertise with cervical cancer screening and HPV vaccination. The investigators~     also have well tested methodologies for cervical cancer screening that are highly effective,~     including self-sampling for HPV and improved specimen transport systems. Therefore, the~     investigators will use these medical interventions as the model preventive health~     interventions for this project.~   "
170172|NCT01338025|"~     The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC)~     alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV~     infected children, adolescents and young adults. The study was to see if there were changes~     in the HIV virus and if there were differences in immune function, viral load and medication~     side effects between the two groups over 28 weeks. Participants were assigned to either take~     3TC or FTC alone or continue on his/her current failing HAART regimen. During the first 28~     weeks of this study, if the participant was randomized to the continue HAART arm, he/she was~     not switched to a different or new, potentially suppressive HAART regimen, but continued on~     the current failing HAART regimen. However, if continuing HAART, the participant might be~     switched to a new regimen if their provider felt that it was clinically needed or the~     participant met certain study endpoints (e.g., drop in CD4, increase in viral load).~      At the end of 28 weeks, the participant had the choice of remaining on the assigned study~     group medication(s) or starting a new HAART regimen prescribed by his/her doctor. Then, they~     would be followed for another 24 weeks to compare the difference in immune function, viral~     load and medication side effects between the different groups.~   "
170173|NCT01338012|"~     Multicenter open label, uncontrolled study that enrolled men with metastatic castrate~     resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent~     setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up~     (LTFU) Phases.~   "
170174|NCT01337999|"~     The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary~     during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that~     is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these~     malignant conditions. In order to optimize the utility of HE4 as a tumor marker in~     premenopausal women, its expression in the normal menstrual cycle needs to be characterized.~     We hypothesize that HE-4 levels do not vary in the menstrual cycle.~   "
170175|NCT01337986|"~     Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and~     blinded cross-over trial of dalfampridine of 8 weeks duration The study will test the~     hypothesis that dalfampridine, when administered to subjects with incomplete visual recovery~     after optic neuritis from MS, will result in symptomatic improvement in visual function. The~     study will consist of one screening/baseline visit, one visit during treatment with active~     drug, and one visit on placebo. After the baseline visit, subjects will be randomly assigned~     to receive study medication or placebo for the first three weeks, followed by a two week~     wash-out, and then treatment reallocation for the latter three weeks.~   "
170176|NCT01337973|"~     The purpose of this study is to examine the impact on both clinical (violence and substance~     use) outcomes and health services use (substance use disorder and mental health treatment)~     compared to standard SUD treatment (enhanced treatment as usual) of~        1. an integrated Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) violence~          prevention treatment intervention delivered during the 8-week early substance use~          disorder treatment phase; and~        2. MI-CBT plus a continuing care (CC) intervention for the 3-month continuing care period~          following the early treatment phase MI-CBT+CC).~      The study will provide important new information regarding the role and relative impact of~     both early treatment and continuing care interventions designed to impact substance use and~     violence, and whether combining such interventions yields additional benefits.~   "
170177|NCT01337960|"~     Veterans and other Americans who survive stroke often face disabling motor impairments that~     impede performance of activities of daily living and limit free-living activity. Prominent~     among these are diminished walking and balance functions, which not only foster a sedentary~     lifestyle and physical deconditioning, but also increase the risk of injuries due to falls.~     Recent research has demonstrated how motor learning based interventions can modify brain~     activity and improve motor functions in persons with stroke. Now there is a major research~     opportunity to advance the effectiveness of these interventions by applying new robotics~     technologies to improve control of essential functions such as gait and balance. One critical~     area for performance of walking and standing balance is the control of the ankles, as they~     are a major conduit of mechanical power in gait and also modulate torques affecting the~     motion of the whole body center of mass when balancing. Thus the current proposal is designed~     to investigate two approaches for using an impedance controlled ankle robot to improve gait~     and balance among stroke survivors with chronic lower extremity weakness. One approach uses~     the ankle robot in a seated visuomotor training program that focuses has subjects play video~     games with the weaker ankle to improve paretic ankle motor control that may carry over to~     gait and balance functions. The other approach uses task-specific gait training by~     integrating use of the ankle robot during treadmill exercise training to assess effects on~     the same functions. The effectiveness of both robotics approaches will be compared to that of~     a treadmill exercise program without robotics.~   "
170178|NCT01337947|"~     The principal hypothesis of this study is that the micro and macro vasculature of young~     diabetes mellitus type 1 (DM1) patients is particularly susceptible to atherogenic factors~     which cause vascular dysfunction at multiple levels of the arterial vasculature and that this~     dysfunction is demonstrable using state-of-the-art ultrasound methods. The investigators~     further hypothesize that interventions, such as exercise, that are readily integrated into~     the daily life of individuals with DM1 can mitigate or reverse these early vascular changes~     and thereby diminish the otherwise predictable longer-term development of cardiovascular~     disease (CVD) in type 1 DM~   "
170179|NCT01337934|"~     The use of albumin in critical ill patients is a matter of controversy. A large randomized~     controlled trial reported that albumin was as safe and effective as crystalloid solution for~     fluid replacement in intensive care unit, although the last one was less expensive. In~     Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids~     over colloids. But recently, a retrospective analysis of patients with severe sepsis from~     SAFE study reported that the use of albumin in these patients would be superior, regarding~     reduction of mortality. The aim of this study is determine whether the use of albumin improve~     clinical outcomes in patients with severe sepsis or septic shock.~   "
170201|NCT01337648|"~     The purpose of this study is to develop fecal tests that will determine the extent of~     radiation exposure in patients undergoing radiation treatment for cancer. This project will~     determine whether fecal biomarkers can be used to diagnose exposure to radiation.~   "
170180|NCT01337921|"~     The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain~     probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34~     weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with~     probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34~     weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL) 1,~     DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24~     months CGA.~   "
170181|NCT01337908|"~     This is a study of factors, such as pain, family support, psychological history and~     alcohol/substance use, that may influence whether a person experiences depression after their~     spinal cord injury.~   "
170182|NCT01337895|"~     -  Objectives Taking a 'whole foods' approach, we will investigate (i) whether consumption~          of isocaloric diets containing ≥4 vs. ≤1 servings of dairy products per day for 16 weeks~          results in greater body fat loss in energy-restricted overweight/obese premenopausal~          women; (ii) the role of dairy product consumption in influencing physiological and~          metabolic factors which may precede or accompany changes in body composition, including~          in enzymes which synthesize and break down body fat; and (iii) factors, including~          obesity phenotype, which may influence the response of body composition to dairy product~          consumption.~        -  Background~      With the obesity epidemic showing no signs of abating, there is ongoing interest, both at the~     lay public and scientific levels, in manipulating the diet to promote weight, specifically~     fat, loss. One such promising manipulation is an increase in, or perhaps more precisely, an~     isocaloric substitution of, dairy product consumption. The inverse association between Body~     Mass Index (BMI) and dietary calcium - for which dairy products are the main source - was~     first described in 1984 and has since been supported by various levels of evidence, but not~     consistently. Heaney recently described this literature as confused, which he and Rafferty~     attribute to important limitations in study design, including lack of low-calcium contrast~     groups and the fact that body weight/body composition is often a secondary endpoint in~     studies designed and powered for a different outcome, typically bone health or blood~     pressure. Confusion has also arisen from the investigation of different interventions (dairy~     products, dairy calcium, dietary calcium, supplemental calcium), making it difficult to~     compare and interpret studies. This creates an opportunity for the proposed Dairy and Weight~     Loss (DAWL) study, with its focus on whole dairy product consumption, to help clear up the~     confusion surrounding this issue.~      **Hypotheses~      Overweight/obese, low habitual dairy consuming, premenopausal women randomized to an~     energy-restricted weight loss diet containing ≥4 servings/day of dairy products (milk,~     yogurt, cheese) for 16 weeks will lose more body fat than those randomized to an isocaloric~     diet containing ≤1 servings/day of dairy products.~   "
170183|NCT01337882|"~     Exposure to particulate air pollution has been shown to increase cardiovascular mortality and~     morbidity, and in previous controlled exposure studies has been shown to have acute~     cardiovascular and respiratory effects. The last decade has seen an unprecedented drive~     towards finding a bioeconomical and renewable source of fuel in order to reduce our~     dependence on fossil fuels. Although both biodiesel and bioethanol have emerged as contenders~     for future fuels, biodiesel remains as the strongest contender within European markets. In~     2007 researchers at the EPA released a commentary, which concluded that the assumed~     correlation between the chemical composition of biodiesel exhaust and a reduction in health~     effects was only hypothetical. They suggested that there was a clear need for the study of~     health effects in humans regarding biofuel exhaust. In this project the investigators aim to~     investigate the cardiovascular, respiratory and inflammatory responses to biofuel exhaust~     exposure in healthy volunteers.~   "
170184|NCT01337869|"~     A pilonidal sinus is a cyst on the natal cleft of the buttocks that often contains hair and~     skin debris. The condition is common and requires surgery to be cured. Several surgical~     procedures are described in literature. Limberg Flap technique is frequently used technique~     for this disease all over the world. However, Bascom Cleft Lift Technique is relatively newer~     technique. The purpose of this prospective randomized study is comparison of these techniques~     about patient satisfaction for postoperative period.~   "
170185|NCT01337856|"~     This is a randomized controlled trial comparing the effectiveness of three hand hygiene~     protocols, during routine inpatient clinical care: Protocol 1: handrubbing with alcohol~     covering all hand surfaces in no particular order; Protocol 2: handrubbing with alcohol using~     the WHO standard 7-step technique; and Protocol 3: handwashing with chlorhexidine using the~     WHO standard 7-step technique.~      The main study hypothesis is that alcohol hand-rubbing covering all hand surfaces is not less~     effective in reducing bacterial hand contamination of healthcare staff than alcohol~     hand-rubbing using 7-step technique; and is more effective than chlorhexidine handwashing.~     The secondary study hypothesis is that time spent on alcohol hand-rubbing covering all hand~     surfaces is less than that required by the other 2 hand hygiene protocols respectively.~   "
170186|NCT01337843|"~     This research will evaluate the efficacy of a new online self- help intervention, the~     Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be~     randomly assigned to use the Wellness Workbook or alternative self-help materials and~     assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome~     measures include pain-related disability and pain severity.~   "
170187|NCT01337830|"~     Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on~     reducing craving for a cigarette in daily smokers.~   "
170188|NCT01337817|"~     Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen~     Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when~     tobacco is smoked.~   "
170189|NCT01337804|"~     This study compares the bioequivalence of omeprazole administered as either Zegerid® powder~     for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants.~   "
170190|NCT01337791|"~     Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic~     hepatitis B patients with few adverse effects, but its use during pregnancy has not been~     explored. In this open-label, prospective study from the second trimester to post-partum week~     28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg~     Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated~     alanine aminotransferase levels.~   "
170191|NCT01337778|"~     A growing body of research indicates that gender-based violence (GBV) is a major global~     public health challenge. Yet, there is a dearth of evidence to guide program planning and~     policy-making efforts to reduce GBV. Our study will evaluate the feasibility, safety, and~     potential effectiveness of an innovative women's empowerment intervention to reduce GBV and~     related adverse health outcomes. It is expected that the study findings will provide evidence~     to determine if a phase 3 effectiveness trial is merited and advance the science underlying~     GBV prevention.~   "
170544|NCT01333124|"~     This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with~     gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.~   "
170192|NCT01337765|"~     This is an open label, dose finding, phase Ib clinical trial to determine the maximum~     tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in~     combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients~     with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast~     cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other~     advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided~     by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion~     arms will be opened in order to further assess safety and preliminary anti-tumor activity of~     the combination of BEZ235 and MEK162.~      Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a~     treatment cycle is defined as 28 days.~   "
170193|NCT01337752|"~     The study will evaluate the effects of BHQ880 in patients with previously untreated multiple~     myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy.~     The primary objective of the study will be to evaluate the effect of BHQ880 in combination~     with bortezomib and dexamethasone, compared to placebo administered with the combination on~     the time to first Skeletal Related Event (SRE) on study.~   "
170194|NCT01337739|"~     Patients undergoing deep sedation for outpatient procedures typically receive a combination~     of benzodiazepines, propofol, and opioids. Side effects of such anesthetics include~     respiratory depression, nausea and vomiting, and urinary retention, with resultant extended~     hospital stays and unanticipated admission. The use of dexmedetomidine for deep sedation may~     increase patient safety by maintaining respiratory drive, while providing sedation, hypnosis,~     and analgesia. Furthermore, patients may experience decreased pain, nausea, and time to~     discharge in the PACU, especially if dexmedetomidine decreases the requirement of other drugs~     such as opioids.~      The hypothesis of this study is administration of dexmedetomidine during deep sedation for~     ambulatory hysteroscopic surgery will result in a 50% reduction of intraoperative opioid~     compared to sedation with propofol.~   "
170195|NCT01337726|"~     The purpose of this research study is to test a program developed to help patients with~     chronic heart or lung problems take care of themselves and cope with their illness or~     limitations.~   "
170196|NCT01337713|"~     There is an impressive and growing body of data suggesting that massage therapy is effective~     in decreasing some symptoms of pathological conditions as well as facilitating growth,~     reducing pain, increasing alertness, diminishing symptoms of depression and anxiety, and~     enhancing immune function. Preliminary studies suggest that massage therapy decreases~     symptoms of anxiety and depression, and lowers salivary cortisol levels in a wide array of~     childhood and adult neuropsychiatric disorders including post-traumatic stress disorder,~     attention-deficit-disorder hyperactivity, depression, bulimia and anorexia-nervosa.~     Generalized Anxiety Disorder (GAD) is characterized by the presence of a constellation of~     signs and symptoms for at least 6 months in duration, with some type of functional disability~     or decrease in quality of life. The signs and symptoms of GAD include a myriad of somatic~     symptoms including muscle tension, headaches, backaches, fatigue, restlessness, insomnia, as~     well as psychological feelings of worry, anxiety, and feeling overwhelmed. Both~     pharmacotherapy and psychotherapy are effective in decreasing the signs and symptoms of GAD.~     Unfortunately, the vast majority of patients with GAD never receive adequate pharmacotherapy~     or psychotherapy. Therefore, the development of a complementary and alternative therapy that~     has demonstrated efficacy for GAD might be well received by patients.~      This study's goals are to investigate the efficacy of Swedish massage therapy vs. light touch~     therapy and better understand the biological effects of massage in patients with anxiety.~     Qualified participants will be randomly assigned to one of two groups in which they will~     receive Swedish massage therapy twice per week for 12 weeks or Light Touch therapy twice per~     week for 6 weeks followed by Swedish massage therapy twice per week for the next 6 weeks. The~     total length of the study is 13 weeks, which includes a screening visit that takes about 3~     hours and two therapy visits per week for 12 weeks that last about 1 hour each. Blood and~     urine will be collected at three of the visits. Compensation is up to $400 for completing the~     entire study.~   "
170197|NCT01337700|"~     Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive~     Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders~     beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates~     suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very~     substantial costs associated with caring for patients with ASD, and ASD has the highest~     Caregiver Burden Scores of any condition. There are three core symptom domains of ASD,~     including social deficits, repetitive behaviors and language deficits. Patients can also have~     associated symptoms of attentional deficits, disruptive behaviors and intellectual~     disability. There is currently no Food and Drug administration (FDA) approved treatment for~     the core symptoms of autism, but risperidone and aripiprazole have FDA approval for~     disruptive behaviors associated with autism.~      This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults~     with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and~     normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a~     role in behavior adaptations and performance.~   "
170198|NCT01337687|"~     Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in~     speech and communication, impaired social functioning and repetitive behaviors and restricted~     interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating~     uterine contractions and milk let-down; however, studies, mainly with rodents and non-human~     primates, has found that OT is involved in affiliative behaviors, including sexual behavior,~     mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of~     social attachment. Moreover, OT is known to play an important role in repetitive behaviors~     and stress reactivity. Given that repetitive behaviors and deficits in social interaction are~     core symptom domains of autism, and that OT is involved in the regulation of repetitive and~     affiliative behaviors, it is believed that OT may play a role in the etiology of autism.~     Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of~     value in treating core autism symptoms. Specifically, synthetic oxytocin administered via~     intravenous infusion to adults with autism spectrum disorders (ASD) produced significant~     reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind,~     placebo-controlled cross-over laboratory challenge.~      Encouraged by these findings, the primary aim of this study is to investigate the safety and~     therapeutic efficacy of intranasal OT in treating repetitive behaviors and social~     functioning/cognitive deficits in adults with ASD. This research embraces a translational~     approach to develop a novel treatment for core ASD symptoms; given that there are currently~     no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms,~     this research addresses an important unmet need in the field. The goal of this study is to~     evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment~     (INOT)administration in adults with ASD.~   "
170199|NCT01337674|"~     This study will evaluate the safety and tolerability of MK-4618 when coadministered with~     antihypertensive agents and will evaluate changes in blood pressure following~     co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis of~     the study is that MK-4618 does not result in a clinically meaningful change in systolic blood~     pressure relative to placebo when co-administered with a beta-blocker or with amlodipine.~   "
170200|NCT01337661|"~     The purpose of this study is to observe how the inflammatory pathways differ in subjects with~     chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).~   "
170202|NCT01337635|"~     Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier,~     inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble~     vitamin that is primarily acquired through local production in the skin after ultraviolet~     light exposure but can also be obtained through natural and supplemental dietary sources.~     This randomized controlled trial will examine the effects of vitamin D repletion on atopic~     dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that~     pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will~     have improved cutaneous disease after treatment with high dose as compared to standard dose~     vitamin D.~   "
170203|NCT01337622|"~     Checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs~     the time to establish full gastric feeding in the early postnatal period.~   "
170204|NCT01337609|"~     The purpose of this study is to determine the safety and effectiveness of a nutritional~     supplement, the probiotic bacteria GanedenBC30. Probiotics are live microorganisms which when~     taken in large enough amounts are supposed to provide a health benefit. The investigators~     would like to see whether this supplement can be used as a treatment for Irritable Bowel~     Syndrome (IBS) and Major Depressive Disorder (MDD). Participants in the study will have both~     IBS and MDD. In order to find out if GanedenBC30 is effective in treating IBS and MDD, the~     investigators will compare it to a placebo. About 32 people will take part in this research~     study. About half of these 32 people will take part at Charles River Medical Associates and~     half will take part at Burlington Medical Associates. Participants will be recruited from~     among patients already being seen at Charles River Medical Associates or Burlington Medical~     Associates for their primary care. The study will last for two months, during which time~     participants will make eight study visits and will take either Ganeden BC30 or placebo. The~     investigators hypothesize that subjects treated with the probiotic will have significantly~     better outcomes with regard to depression and IBS symptoms compared to those who receive~     placebo.~   "
170205|NCT01337596|"~     To evaluate the safety and tolerability of LY2951742 given as a single or multiple~     subcutaneous injection in healthy male subjects~   "
170206|NCT01337583|"~     This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety~     and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.~   "
170207|NCT01337570|"~     This is a double-blind, randomized, placebo-controlled Phase III study to assess the safety~     and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.~   "
170208|NCT01337557|"~     The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution)~     1.5% will have an effect on contact lens wear in patients with contact lens intolerance due~     to allergic conjunctivitis.~   "
170209|NCT01337544|"~     The investigators propose a new antitumor cell therapy for treating childhood refractory~     solid tumours. The aim of this study is explore the graft versus tumour effect mediated by~     allogenic natural killer cells (NKs). NK cell alloreactivity can be predicted by donor killer~     immunoglobulin-like receptors (KIRs) and human leukocyte antigen (HLA) class I alleles~     mismatch. Cells without an inhibitory HLA ligand may trigger natural killer cell activation~     and elimination of those target cells. Reduced risk of relapsed has been described in~     malignant cancer after haploidentical stem cell transplantation when HLA ligands against the~     inhibitory KIRs present in the donor were absent in the recipient (KIR-HLA receptor-ligand~     mismatch). NK alloreactivity could also be obtained by Natural Killer Receptor (NCR),~     Toll-Like-Receptors (TLRs) and NKG2D receptor stimulation mediated by cytokines or tumour~     cell lines.~      This will be an open, non randomized, Phase I/II clinical trial, with a double objective:~     therapeutic exploratory. The investigators aim at studying safety and efficacy of~     haploidentical stem cell transplantation for the treatment of these malignancies with no cure~     known. Patients will receive an haploidentical stem cell transplantation, followed by IL-15~     stimulated NK cells infusion one month after transplantation. Efficacy of the procedure will~     be evaluated with up-to-date radiological techniques, molecular studies and functional~     assays.~   "
170210|NCT01337531|"~     Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when~     either recombinant or highly purified follicle stimulating hormone (FSH) is used.~   "
170211|NCT01337518|"~     This study will evaluate an experimental drug called EZN-4176 to determine the anticancer~     effects when it is given to patients with an advanced form of prostate cancer called~     castration-resistant prostate cancer (CRPC). Goals of this phase I study include finding out~     the dose of EZN-4176 that can be safely given without serious side effects and to determine~     the amount of EZN-4176 that should be given in future studies.~   "
170212|NCT01337505|"~     This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated~     dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450~     mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous~     infusion on Day 1 every 21 days for up to 6 cycles.~   "
170213|NCT01337492|"~     Patients with either histological confirmation or clinical diagnosis who are candidate for~     orthotopic liver transplant(OLT) will receive Sorafenib 400mg 2 x day (BID) as a neoadjuvant~     (bridging) treatment until transplant. If patient progresses or falls outside of the Milan~     criteria on sorafenib patient can be treated per physician's discretion using local therapy.~     Patient will be followed until 30 days after the orthotopic liver transplant (OLT).~   "
170214|NCT01337479|"~     The purpose of this study is to follow patients treated in entecavir Phase III and rollover~     studies for safety experience and Hepatitis B virus (HBV)-related complications.~   "
170215|NCT01337466|"~     This protocol will evaluate the biodistribution and dosimetry of [124I]FIAU in both healthy~     volunteers and patients with prosthetic joint infections. This pilot study will also~     investigate the safety and tolerability of [124I]FIAU.~   "
170232|NCT01337232|"~     This study is designed to examine how much therapy is needed in order to make significant~     gains in knowledge and use of complex sentences. Students will be randomly placed in~     individual treatment sessions that take place either once or twice per week for nine weeks.~     All will receive the same type of treatment, which consists of a focused series of oral and~     written language activities. While it is anticipated that students in both groups will~     benefit from treatment, we hypothesize that the twice-weekly session frequency will have a~     significantly greater impact on level of performance and maintenance of skills after~     treatment.~   "
170216|NCT01337453|"~     Botulinum toxin (BoNT) has become a revolutionary treatment for many neurological, autonomic,~     gastrointestinal, genitourinary, and cosmetic disorders. The use of this treatment requires~     expertise in dosage calculations and application technique to avoid potential side effects.~     Most adverse events (AEs) related to BoNT are local and related to its mechanism of action,~     i.e., paralysis of unwanted muscles. However, systemic AEs may also be observed. Flu-like~     symptoms (FLS) are well recognized AEs in patients treated with BoNT; however there is a~     paucity of information regarding the frequency, clinical impact, and associated risk factors~     of this particular complication.~      Between December 1989 and May 2003, 1,437 reports of BoNT-related AEs were registered at the~     Food and Drug Administration (FDA). FLS were reported in 4.6% of serious, and 3.2% of~     non-serious side effects.~      In this study, the investigators aim to assess prospectively the frequency, clinical~     characteristics, and risk factors for development of FLS in a group of patients affected with~     diverse movement disorders and treated with BoNT type A at the Parkinson's Disease Center and~     Movement Disorders Clinic (PDCMDC) of Baylor College of Medicine (BCM). The investigators~     will also assess biomarker of inflammatory response in those patients who develop FLS after~     treatment with BoNT.~   "
170217|NCT01337440|"~     1. Objectives~        1. To test whether Ursodeoxycholic Acid (UDCA) increases Glucagon-like peptide-1 (GLP-1)~          response to nutrients and improves glycemic control in people with type 2 diabetes.~        2. To test whether sitagliptin enhances UDCA-induced beneficial effect in GLP-1 levels and~          glycemic control.~        3. To test safety of combination therapy of sitagliptin and UDCA in people with type 2~          diabetes.~      2. Clinical hypothesis.~        1. UDCA increases GLP-1 response to nutrients via provoking bile acids excretion from the~          liver to the intestine/colon.~        2. UDCA improves glycemic control in people with type 2 diabetes.~        3. Sitagliptin enhances UDCA-induced response of GLP-1 to nutrients.~        4. Sitagliptin has additive beneficial effects with UDCA in glycemic control in people with~          type 2 diabetes.~        5. Combination therapy of sitagliptin and UDCA is safe and well-tolerated in people with~          type 2 diabetes.~        6. The combination therapy may loose weight by unique mechanisms of each agent; GLP-1~          inhibits appetite by acting on CNS and gastrointestinal motility, whereas UDCA-enhanced~          circulating primary bile acids increases energy expenditure through the pathway~          involving G protein-coupled bile acid receptor 1 (Gpbar1, or M-Bar, TGR-5) and~          subsequent activation of type 2 iodothyronine deiodinase (D2) in brown adipose and~          muscle tissues, as reported previously.~   "
170218|NCT01337427|"~     This research sub-study is being completed as a part of the Multicenter, Randomized,~     Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of~     PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis~     (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017~     by measuring the nerve fiber thickness in the eye.~   "
170219|NCT01337414|"~     Exudative age-related macular degeneration (wet AMD) continues to be a leading cause of~     central vision loss in the US for those over fifty years of age, despite the availability of~     several effective interventions to contain damaging neovascularization (new, abnormal blood~     vessel growth). The effectiveness of treatments is challenged by patients' lack of ability to~     recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi~     tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling~     patients to recognize the signs that they should consult their retina specialist for~     treatment.~      For optimal benefit, patients should be able to self-monitor their vision over time and~     detect changes that may be indicative of an exudative event. To facilitate compliance these~     observations should be part of a larger and more engaging program of AMD awareness and~     self-monitoring. Among the principal shortcomings of the current gold-standard Amsler grid~     are periodicity of the test pattern and lack of individual adjustment, and therefore the~     reliability and accuracy of this test are less than optimal for the detection of exudative~     retinal changes in AMD patients. In phase I of the current study, the investigatorsW~     developed and evaluated several versions of improved grids, both on paper and on the~     Internet. These patent-pending Visual and Memory Stimulating (VMS) grids proved at least~     equivalent to the Amsler grid in facilitating a substantial degree of recall of prior~     measurements, necessary for monitoring vision over time. Adjustment features were~     incorporated in the on-line version to allow patients to customize their grid to their~     particular visual field. In the phase II study the use of VMS grids will be supplemented by a~     test booklet that contains educational materials and diary based survey questions in addition~     to the printed VMS grids; the effectiveness of this booklet for self-monitoring will be~     compared the standard of care (Amsler grid).~      Goal of the study is to demonstrate that use of the test booklet leads to more rapid~     identification of newly developing vision problems, earlier diagnosis and treatment of~     incipient wet AMD that should result in fewer people losing their vision and less severe~     losses of vision.~   "
170220|NCT01337401|"~     The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial~     of cediranib in Alveolar Soft Part Sarcoma (ASPS).~      The study aims to confirm the ability of cediranib to halt disease progression in patients~     with metastatic ASPS, as measured by the change in tumour size at 24 weeks after~     randomisation, and to produce objective response according to RECIST criteria.~   "
170221|NCT01337388|"~     This observational study will assess the efficacy and safety of RoActemra/Actemra~     (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from~     patients treated in routine clinical practice with intravenous RoActemra/Actemra will be~     collected for 12 months each.~   "
170222|NCT01337375|"~     In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon~     alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with~     viral load and viral kinetics will be investigated in patients with chronic hepatitis C~     genotype 1 who were non-responders to previous standard combination therapy with pegylated~     interferon and ribavirin. Patients will be randomized to receive either weekly or twice~     weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after~     a washout period of 6 weeks.~   "
170223|NCT01337362|"~     Patients with type 1 diabetes are at risk of very low blood sugar levels (hypoglycaemia) as a~     severe side effect to insulin therapy, in particular subjects who have lost warning of~     hypoglycaemia. During hypoglycaemia a low frequent activity can be seen with~     electroencephalography (EEG) as cognitive function declines.~      The purpose of the study is to investigate the activity in the brain, the cognitive function,~     and the skin temperature when patients are exposed to repeated hypoglycaemia. The results~     will show whether the response to hypoglycaemia will change after repeated episodes.~      It is our hope that results can contribute to improved understanding of hypoglycaemic EEG~     changes.~   "
170399|NCT01335022|"~     The investigators seek to demonstrate that interactive physician-led education through~     partnership with an African American church will improve awareness and knowledge of~     cardiovascular disease in the African American community and will result in objective~     improvement in major risk factors associated with cardiovascular disease (CVD).~   "
170224|NCT01337349|"~     This is a prospective, double blinded randomized clinical study to evaluate the Effects of~     Pentoxifylline on left ventricular systolic function indices and circulating biomarkers in~     patients with chronic congestive heart failure.~      A few studies all focused in Africa have consistently shown marked beneficial effects of~     pentoxifylline in improvement of left ventricular size and systolic function along with~     marked decrease in biomarkers of heart failure and apoptosis markers on top of standard CHF~     therapy. Furthermore pentoxifylline was shown to have negligible effects on heart rate, blood~     pressure in those studies. Limitations of these studies are that they are largely single~     center originating in the African subcontinent and have never been tested in the North~     American population, particularly Caucasians.~      Despite major advances in medical therapy for congestive heart failure, it is still one of~     the leading causes of morbidity and mortality in North America. Most medications tested for~     improvement of Ejection Fraction with the exception of Beta-Blockers and Ace-Inhibitors have~     been associated with worsening mortality. Pentoxifylline is a medication that has negligible~     effects on myocardial oxygen consumption, yet promising effects on inflammatory markers seen~     in CHF with the possibility of improvement in LV systolic function and symptomology and may~     prove to be a useful addition for CHF patients. This would prove to be especially useful,~     particularly when associated with no major side effects.~   "
170225|NCT01337336|"~     The objective of this study was to examine COPD-related outcomes for patients with comorbid~     depression/anxiety who are on combination fluticasone propionate/salmeterol xinafoate~     compared to those receiving anticholinergics.~      The prevalence of comorbid depression/anxiety in patients with chronic obstructive pulmonary~     disease (COPD) is estimated to be high and range from 10-40%, given that the risk of~     depression/anxiety symptoms is almost 3 times higher in patients with versus without COPD.~     Additionally, patients with comorbid COPD and depression/anxiety have higher COPD-related~     healthcare utilization and costs compared to those without depression/anxiety. Therapy with~     maintenance medications for COPD has been recommended to prevent future adverse COPD~     outcomes, but the impact of initiating these interventions has not yet been evaluated in a~     higher-risk population with comorbid COPD-depression/anxiety. The present study compares the~     risk of COPD exacerbations and COPD-related costs in patients initiating maintenance~     medications for treatment of COPD in a comorbid COPD/depression-anxiety population.~     Maintenance medications include inhaled corticosteroid (ICS), long-acting beta agonist~     (LABA), combination drug product of ICS+LABA, and anti-cholinergics (AC) including tiotropium~     (TIO) and ipratropium or combination ipratropium-albuterol (collectively abbreviated as IPR).~   "
170226|NCT01337323|"~     This study is a prospective observational cohort study with 3-month follow-up among a cohort~     of intranasal steroid (INS) -experienced patients newly starting fluticasone furorate nasal~     spray (FFNS). The primary aim is to examine the effect of FFNS on the use and associated cost~     of concomitant allergic rhinitis medications in INS-experienced patients starting treatment~     with FFNS who have a history of prior concomitant medication use. The secondary aim will be~     to determine the effect of FFNS on control of allergic rhinitis, as assessed by the Rhinitis~     Control Assessment Test (RCAT).~      Adult patients filling a new FFNS prescription will be recruited (within 4 days of starting~     their FFNS) across 50 branches of a retail pharmacy chain with co-located convenient care~     clinics. Approximately 350 patients who have active seasonal rhinitis and have used an INS~     other than FFNS and another prescription or over-the-counter allergy medication in the~     previous allergy season will be eligible for the study. A baseline questionnaire will be~     administered to collect information on patient demographics, a brief medical history of the~     patient's rhinitis, prior use of INS and other prescription and over-the-counter medications~     taken for allergic rhinitis, total out of pocket costs for the prior allergy season, number~     of office visits due to allergic rhinitis, and level of control of symptoms of allergic~     rhinitis.~      At 1, 2, and 3 months post-enrollment, a follow-up questionnaire will be administered to~     collect information on medications taken for allergic rhinitis, office visits due to~     rhinitis, and level of control of symptoms of allergic rhinitis. In addition, pharmacy claims~     data will be abstracted for patients 1 year prior to enrollment and 4 months after enrollment~     to verify and supplement patient reported data as needed.~      The primary outcomes will be rate of use of non-INS concomitant medications (frequency and~     duration) at baseline, and 1, 2, and 3 months follow-up and change in rate of use of non-INS~     concomitant medications (post vs. pre and from baseline to 3 months follow-up). Secondary~     outcomes will be change in total allergic rhinitis pharmacy expenditures (post vs. pre and~     from baseline to follow-up) and change in the level of control of allergic rhinitis, as~     measured by score on the Rhinitis Control Assessment Test (RCAT), from baseline to follow-up.~   "
170227|NCT01337310|"~     Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of~     tesetaxel in Japanese patients has been limited. This study is being conducted to determine~     the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to~     Japanese patients.~   "
170228|NCT01337297|"~     The use of crack-cocaine is growing at alarming rate in our country and it is absolutely~     worrisome the fast establishment of addiction to it. Its immediate effects, that are intense~     and extremely fleeting, increase dramatically the probability of this drug to be consumed~     again, settling quickly down the loss of control and the compulsive use, turning the effects~     of this drug highly addictive. Parallel to this process, brain damages are quickly~     established, progressing to severe impairments of frontal functions, leading to the lack of~     cognitive control that feeds back and aggravates the dependence, and hampers any therapeutic~     approach. The existing treatments have not proved to be satisfactory yet. Thus, considering~     that a new modality of treatment, based on the neuromodulation induced by noninvasive brain~     stimulation, has been useful in treating various neuropsychiatric conditions, this study will~     examine the potential beneficial effects of repeated transcranial Direct Current Stimulation~     over the left dorsolateral prefrontal cortex in the treatment of crack-cocaine addiction.~   "
170229|NCT01337271|"~     The purpose of this study is to compare a new mode of mechanical ventilation (NAVA, or~     Neurally adjusted Ventilatory assist) with a traditional mode (Pressure Support ventilation)~     on its the ability to detect patients ready for extubation (liberation from mechanical~     ventilation).~   "
170230|NCT01337258|"~     The objective of this project is to conduct a retrospective economic analysis of the use of~     dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical~     trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical~     trial of the use of dutasteride compared with no chemopreventive treatment.~      The REDUCE trial was a four-year, international, multicenter, randomized, double-blind,~     placebo-controlled, parallel group study. There were 790 investigators in 42 countries.~   "
170231|NCT01337245|"~     The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and~     death from the bite of a coral snake.~      Funding Source - FDA OOPD.~   "
170382|NCT01335243|"~     The main objective of this clinical study is the estimation of the rate of intersomatic~     fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK~     interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous~     substitute with a biomaterial (MatriBONE associated with the autologous bone marrow),~     associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow.~     Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow lumbar~     canal and\or spondylolisthesis.~   "
170233|NCT01337219|"~     Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis~     Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the~     respiratory affection which appears early in neonates.~      The constant improvement in symptomatic treatments and care strategies allowed CF patients'~     life expectancy to be increased over the last decades.~      Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years~     old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.~      Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is~     obtained by inhaled administration of tobramycin and is active against in-vitro resistant~     Pseudomonas aeruginosa.~      Study hypotheses :~      Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml~     administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of~     antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus®~     in children and adult patients with CF.~      Primary objective :~      To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by~     Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®~   "
170234|NCT01337206|"~     The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign~     esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to~     standard therapy, (2) achalasia refractory to standard therapy.~   "
170235|NCT01337193|"~     The overall purpose of this research is to determine the effect of ultrasound imaging~     biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women~     with stress urinary incontinence. This study will include women 20 years or older with stress~     urinary incontinence.~      The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using~     transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone~     (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group~     A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback.~     Group B will perform the same 3 pelvic floor exercises without biofeedback.~      All participants involved in the study will complete a general medical information~     questionnaire. In addition, all participants will have their PFM contraction assessed using~     an ultrasound machine placed over the lower abdomen, quality of life assessed with a written~     questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at~     completion of the study.~   "
170236|NCT01337180|"~     Exposure to noxious gases and particles is associated with an increased prevalence of~     respiratory and cardiovascular diseases. Thus, investigation of possible airway inflammation~     and/or systemic inflammation in workers exposed to high levels of dust is important. Silicon~     Carbide (SiC) Processing Inc. provides cutting fluid (slurry) for the production of solar~     cells and is at present the largest provider of slurry to the solar industry worldwide. In~     the production process, the recyclable materials (SiC), polyethylene glycol (PEG)) of the~     used slurry are recovered. The airborne exposure consists mainly of SiC (dust particles) and~     evaporation from the recycling of PEG. High levels of dust have been measured and, seventeen~     per cent of the measurements in the processing hall were equal to or higher than the~     Norwegian occupational exposure limit. Thus, assessment of possible systemic and airway~     effects of this exposure is of interest. A prospective design will be applied and the effects~     studied by means of registration of respiratory symptoms, spirometry, nitric oxide (NO) in~     exhaled air, induced sputum and blood sampling over a 3 year period. Exposed subjects will~     also be compare with non- or low exposed subjects (administrative/office workers). Efforts~     will be made to include all eligible subjects and to avoid drop-outs. If early signs of~     airway or systemic inflammation in workers or in cells are demonstrated in the study, it will~     be necessary to implement measures to reduce the exposure levels.~      The primary aim of the present study of workers exposed to Silicon Carbide dust in the~     workplace is to determine whether this exposure is associated with inflammatory changes in~     the lungs.~      The secondary aims are: - to examine possible changes in systemic inflammatory markers and -~     to examine changes in lung function among Silicon Carbide processing workers during a period~     of 3 years. Possible changes in lung function will be monitored by spirometry and gas~     diffusion measurements (study A). Airway inflammatory responses and changes in circulating~     inflammatory markers will be assessed by examination of the induced sputum samples and blood~     samples every 6th month in a subgroup of workers (study B).~   "
170237|NCT01337167|"~     This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when~     administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of~     DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether~     subjects who receive V419 have a similar immune response to the vaccine compared to subjects~     who receive licensed component vaccine controls.~   "
170238|NCT01337154|"~     The goal of this study is to determine the progression-free survival and objective response~     rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are~     treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or~     placebo. Subjects will be randomly assigned to receive tamibarotene, 6 mg/m2, divided as~     twice daily orally, or an equal number of matching placebo tablets, starting 1 week before~     chemotherapy and continuing through all 6 cycles and beyond. Subjects will be assessed for~     response on Day 50, Day 113, then every other month using the Response Evaluation Criteria in~     Solid Tumors (RECIST 1.1).~   "
170239|NCT01337141|"~     A greater visit frequency between the diabetes mellitus 1 (DM1) patient and the medical team~     increases the possibilities to improve metabolic control. The support of telematic visits can~     support the patient and the health system.~      Patients and Method: 160 patients (from 5 participating centres) with type 1 diabetes~     mellitus (DM1) candidates for improved metabolic control selected according to inclusion and~     exclusion criteria. The telecare system used is comprised of the patient Unit and the doctor~     Unit. The system allows the patient to send glucose values, insulin doses, carbohydrate~     contribution and other events via the internet. Both the patient and the professional can use~     this information via the telecare system platform.~      Work hypothesis~      The application of interactive telematic systems between patient-health team will improve the~     cost effectiveness of care programmes for optimisation of metabolic control directed towards~     diabetes mellitus (DM1) patients.~      Objectives:~      General Objective Evaluate the impact of the telecare system on the efficiency of economic~     and clinical management of human and material resources directed to a program of metabolic~     control optimisation in diabetes mellitus 1 (DM1) patients as well as the level of metabolic~     control and the quality of life of the patients.~      Specific objectives~        1. To identify and analyse the influence of the telecare system on patient costs in time,~          money and normal work or school activity which the patient has to stop to carry out the~          physical visits for following the programme.~        2. To identify and analyse the influence of the telecare system on medical team costs in~          time, money and care organisation directed towards the monitoring phase of the metabolic~          control care programme.~        3. To identify and analyse the influence of the telecare system on the level of metabolic~          control: Glycosylated haemoglobin and the presence of acute hypoglycemic and~          hyperglycaemic complications in diabetes mellitus 1 (DM1) patients that follow the~          metabolic optimisation programme.~        4. To identify and analyse the influence of the telecare system on the quality of life of~          the patient measured in satisfaction scale, impact, social/work concern and concern~          relating to diabetes.~        5. To identify and analyse the influence of the telecare system on the adherence to~          different treatment components.~   "
170266|NCT01336777|"~     The biological basis for insulin resistance associated with obesity is unknown. By studying~     equally-overweight/obese individuals who are either insulin resistant or insulin sensitive,~     the investigators will compare characteristics of fat tissue to test several hypotheses: 1)~     impaired differentiation and fat storage in the subcutaneous fat depot characterize insulin~     resistant individuals, who have, as a result, fat in other tissues like liver and muscle, as~     well as more fat circulating in the blood; 2) inflammation is greater in visceral and/or~     subcutaneous adipose tissue depots in insulin resistant individuals as compared with insulin~     sensitive individuals.~   "
170240|NCT01337128|"~     In this prospective study, patients with carotid stenosis will be randomly assigned to one of~     the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre-~     and postoperative neuropsychological functions, levels of several biomarkers and~     intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will~     also be gathered. The mix of these data will allow us to answer several questions regarding~     the absence or presence of preoperative impairments, postoperative changes in cognitive~     performance and possible differences between CEA and CAS regarding postoperative~     neuropsychological functions. The use of a matched control group and implementation of a long~     term follow-up will contribute to the uniqueness of this study. It will meet several flaws of~     previous studies and will complete the ongoing randomized studies comparing CEA and CAS that~     are lacking neuropsychological data.~   "
170241|NCT01337115|"~     The purpose of this study is to determine if the addition of a sciatic nerve block (SNB) to a~     continuous femoral nerve block (CFNB) improves post-operative analgesia after knee~     arthroplasty.~   "
170242|NCT01337102|"~     In the treatment of advanced cancer, maximizing quality of life (QoL) is a fundamental goal~     for oncologists and their patients. In order to achieve this goal, some form of systematic~     and reliable QoL assessment is needed in routine clinical practice to evaluate the impact of~     advanced cancer treatments on QoL. The Lung Cancer Symptom Scale (LCSS) is a validated~     site-specific QoL measure designed for use in patients with lung cancer undergoing treatment.~     Recently it has been developed into an electronic form that uses a hand-held pocket personal~     computer (pc) to enhance collection and presentation of QoL assessments into clinical trials~     and patient care. This study will evaluate the impact of this computer-generated QoL~     (LCSS-QL) assessment on treatment practices for advanced lung cancer patients using a~     randomized trial design. The investigators hypothesize that a Computer-Generated Quality of~     Life Assessment Program will positively impact treatment patterns for patients with lung~     cancer.~      Specifically, the investigators hypothesize:~        1. Use of the LCSS-QL will increase and accelerate referral to and use of palliative care~          services;~        2. Use of the LCSS-QL will decrease the duration of palliative chemotherapy treatment with~          earlier identification of lack of benefit in some patients;~        3. Use of the LCSS-QL may decrease the use of imaging tests to assess objective tumor~          response as an indicator of treatment benefit.~      Maximizing quality of life is one of the most important goals of palliative chemotherapy in~     the treatment of advanced lung cancer. If this simple practical tool can be demonstrated to~     improve palliative management of these patients, including optimizing duration of~     chemotherapy and use of palliative and supportive services based on patient QoL response,~     this will dramatically improve the quality of care provided to advanced lung cancer patients.~     This study will also provide a springboard for other ways to incorporate computer-generated~     QoL measurement in treatment decision-making in advanced cancer patients, including in other~     tumor types such as advanced breast and colorectal cancer.~   "
170243|NCT01337089|"~     This was a six-month open-label extension (OLE) study to evaluate the safety of long-term~     nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with~     advanced cancer. The study provided continued availability of nabiximols to participants who~     completed a preceding Phase 3 study and new (de novo) participants.~   "
170244|NCT01337076|"~     The Sponsor values the progression of hearing healthcare practice and acknowledges a need for~     re-evaluation of indications for determining adult cochlear implant candidacy. This need~     arises from current research, peer reviewed literature, and technological advancement with~     concomitant performance outcomes. To address this specifically, the Sponsor proposes to~     evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised~     indication.~   "
170245|NCT01337063|"~     Patients often have problems after they leave the hospital, in part because errors are made~     in the medications they are prescribed. The goal of this project is to develop a more~     accurate and safe medication prescription process when patients enter and leave the hospital~     and implement this process at six U.S. hospitals. The investigators will measure the success~     of the project and develop lessons learned so this process can be applied to other hospitals.~   "
170246|NCT01337050|"~     This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose~     escalation and designed to define the Maximum Tolerated Dose [MTD] and the Recommended Phase~     2 Dose [RP2D].~   "
170247|NCT01337037|"~     The purpose of this study is to modify the surgical technique of VATS (video-assisted~     thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer.~   "
170248|NCT01337024|"~     Heart rate variability (HRV) is an important indicator of cardiac autonomic function and~     predictor of cardiac mortality and of all-cause mortality. In this study the investigators~     examined changes of the HRV in patients with neurogenic detrusor overactivity (NDO)~     undergoing botulinum neurotoxin type A intradetrusor injections (BoNT/A).~   "
170249|NCT01337011|"~     This is a pilot study comparing the effect of intra-coronary versus intramyocardial~     application of enriched CD133pos autologous bone marrow derived stem cells for improving left~     ventricular function in chronic ischemic cardiomyopathy.~   "
170250|NCT01336998|"~     Calprotectin is a cytosolic component of neutrophils .Fecal calprotectin(FC) is a useful~     marker for exacerbation of inflammatory bowel disease in children .FC may be a useful marker~     for necrotizing enterocolitis (NEC).~      NEC is one of the most common ,deadliest and enigmatic intestinal problems encountered mostly~     in premature infants. The precise pathophysiology of NEC is unclear ,but major factors~     thought to play an important role include an immature intestine ,an inflammatory response to~     intestinal microbes,enteral feedings and intestinal ischemia-reperfusion injury.Diagnosis of~     NEC is not easy clinically and up to now there is not a simple laboratory test to~     differentiate NEC at an early stage from other conditions in the neonate.~      Arginine is the substrate for NO production in the gut and its deficiency may cause~     vasoconstriction and gut injury and thus predispose to NEC. In previous studies arginine~     supplementation was found to reduce the incidence of NEC in premature infants but more~     studies are needed for the use of arginine supplementation for the prevention of NEC.~      The investigators aim is to measure the fecal calprotectin in very low birth weight (VLBW)~     infants during the first month of life as an inflammatory marker of the bowel and evaluate~     whether premature infants receiving arginine supplements had lower calprotectin values~     compared to the premature infants that did not .~      The investigators hypothesize that arginine supplementation in preterm infants reduces the~     inflammation of the gut which will be shown by the lower fecal calprotectin values of the~     premature infants receiving arginine supplementation.~   "
170267|NCT01336764|"~     Many U.S. military personnel are returning from Operation Enduring Freedom/Operation Iraqi~     Freedom (OEF/OIF) deployments with histories of trauma while driving in military vehicles.~     The proposed project aims to develop and test a rehabilitative technology aimed at enhancing~     emotion regulation and reducing operator-related risk during civilian driving.~   "
170383|NCT01335230|"~     The purpose of this research study is to explore what role immune cells within the gut (the~     sigmoid colon) have locally and on the immune system of patients infected with HCV, HIV or~     HCV/ HIV co-infection.~   "
170251|NCT01336985|"~     Background:~        -  Cancers in other parts of the body often spread to the liver, developing tumors which in~          many instances cannot be removed with surgery. Liver chemoembolization is a treatment~          that is routinely performed to control liver tumors in those who cannot have surgery. It~          has been shown to prolong survival, but does not cure the cancer. During~          chemoembolization very tiny beads (drug-eluting beads, or DEB) containing chemotherapy~          drugs (usually doxorubicin) are administered directly into the blood vessels of a liver~          tumor. The drug within the beads is then released into the tumor whilethe beads~          temporarily interrupt the tumor s blood supply.~        -  Irinotecan, a drug commonly given intravenously to treat colon cancer, has been given in~          chemoembolization procedures in four other studies that have shown that the treatment is~          generally well tolerated. Researchers are interested in determining whether giving the~          drug irinotecan directly into the liver using drug-eluting beads is not only well~          tolerated but also provides a larger dose directly to the tumor as determined by tumor~          and normal liver tissue biopsies. The liver biopsies are an optional portion of the~          study.~      Objectives:~      - To evaluate the safety and effectiveness of chemoembolization with irinotecan for tumors~     caused by cancer that has spread to the liver.~      Eligibility:~      - Individuals at least 18 years of age who have melanoma, colon, or another intra-abdominal~     cancer that has spread to the liver.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          tumor imaging studies, and liver biopsies.~        -  Participants will receive up to 3 DEB chemoembolization treatments about 6 weeks apart.~        -  After two treatments, participants will have imaging studies to see if the tumors have~          shrunk, and those whose tumors have shrunk may have a third treatment.~        -  Multiple liver biopsies may be performed and blood samples will be taken to determine~          how much drug is in the tumor and the circulation, and to see how the tumor reacts to~          the drug.~        -  Participants will return for followup visits for up to 1 year....~   "
170252|NCT01336972|"~     The purpose of the trial was to determine the short-term effects of tolvaptan in patients~     with autosomal dominant polycystic kidney disease (ADPKD) at various levels of renal~     function.~   "
170253|NCT01336959|"~     This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients~     undergoing cardiac surgery with cardiopulmonary bypass.~   "
170254|NCT01336946|"~     Overweight and obesity have become a serious global public health problem and the prevalence~     of these conditions is even higher among persons with mental disorders, compared with the~     general population. Overweight and obesity are partially associated with sedentary lifestyles~     and unhealthy eating habits.~      The aim of the study is to examine the effectiveness and cost-effectiveness of a health~     promotion intervention targeting physical activity and eating habits in persons with mental~     disorders.~      The study hypothesis is that between baseline and the end of the intervention, and after a~     6-month follow up period, significant differences in the primary and secondary outcomes~     between the intervention and control group will be identified. The investigators also~     hypothesize that the health promotion intervention will be cost-effective.~   "
170255|NCT01336933|"~     This phase II trial studies how well combination chemotherapy and pralatrexate works in~     treating patients with non-Hodgkin lymphoma (NHL). Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing~   "
170256|NCT01336920|"~     This phase I trial studies the side effects and best dose of carfilzomib in treating patients~     with relapsed or refractory T-cell lymphoma. Carfilzomib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth.~   "
170257|NCT01336907|"~     The FORESEE HOME is intended for the early detection of central and paracentral~     irregularities (abnormalities) in the visual field, most commonly associated with Age Related~     Macular Degeneration (AMD). However, the device has the ability to detect the development of~     the lesion post treatment and therefore to assess in determination of the next treatment.~      The Optical Coherence Tomography (OCT) may be used as well to identify choroidal~     neovascularization (CNV). Comparison between the two methods will allow better understanding~     of both devices.~      The FORESEE HOME can be used as an assessment tool for the progression and success of the~     treatment given to AMD lesions. Therefore, evaluating the size and the location of the~     treated lesions may serve as an additional tool.~   "
170258|NCT01336894|"~     RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment~     for non-small cell lung cancer. Internal radiation uses radioactive material placed directly~     into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to~     send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known~     whether stereotactic body radiation therapy is more effective than surgery with or without~     internal radiation therapy in treating non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying how well surgery with or without~     internal radiation therapy works compared with stereotactic body radiation therapy in~     treating patients with high-risk stage IA or stage IB non-small cell lung cancer.~   "
170259|NCT01336881|"~     This research trial is studying biomarkers in tissue samples from young patients with liver~     cancer. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~   "
170260|NCT01336855|"~     This study seeks to confidentially collect blood from HIV-positive individuals and~     HIV-negative controls to provide basic scientists with specimens for collaborative studies.~   "
170261|NCT01336842|"~     The purpose of this study is to find out if panobinostat taken with cisplatin and pemetrexed~     can be used safely without increasing side effects and that the combination will have a~     better effect than platinum-based doublet chemotherapy alone.~   "
170262|NCT01336829|"~     The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is~     absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed~     into the body when administered together.~   "
170263|NCT01336816|"~     This is a study to determine the safety and effectiveness of silver salt in Ariva® Silver~     Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the~     smoker when tobacco is smoked.~   "
170264|NCT01336803|"~     This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with~     ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors~     to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help~     in diagnosing patients correctly and may result in more timely treatment.~   "
170265|NCT01336790|"~     The purpose of the National Lymphatic Disease and Lymphedema Registry is to collect health~     information in order to study the disease classification, natural history, and impact of~     Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.~   "
170396|NCT01335061|"~     The purpose of this study will be to determine if a once-weekly prophylaxis regimen of~     BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.~   "
170268|NCT01336751|"~     Study Primary Objectives:~      To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine~     and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in~     subjects who failed oral combination therapy with sulfonylurea and metformin.~      Study Secondary Objectives :~      To compare the following measures between subjects receiving insulin glargine or 75% insulin~     lispro protamine suspension/25% insulin lispro:~        -  Incidence of hypoglycemia~        -  Change in weight~        -  Change in serum lipid profile~        -  Percentage of subjects achieving A1C levels ≤7%~   "
170269|NCT01336738|"~     B2611002 is designed to study how safe and effective an investigational medication~     (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5~     treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug,~     and another treatment will be placebo, which does not contain active ingredient.~   "
170270|NCT01336725|"~     The purpose of this study is to determine whether the participants have improved their scores~     on health related quality of life (HRQL) 1 year after completing a learning and mastery~     course and whether sociodemographic variables are associated with HRQL.~   "
170271|NCT01336712|"~     In this study, patients will receive a myeloablative preparative regimen consisting of~     fludarabine and total body irradiation (TBI), followed by a T cell replete, mobilized~     peripheral blood stem cell (PBSC) allograft from a partially matched related donor. All~     patients will receive post-transplant Cy in addition to standard post transplant~     immunosuppression with tacrolimus and MMF. The treatment protocol will be essentially~     identical to the prior study, with the exception of the substitution of TBI for Busulfan. The~     investigators hypothesize that this change will significantly reduce the risk of HC, while~     maintaining the efficacy of the transplant.~   "
170272|NCT01336699|"~     Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of~     single doses of S. sonnei. Health adult subjects, ranging in age from 18 to 45 years of age~     (inclusive) will be screened. Enroll serial groups up to 90 subjects. The primary objective~     is to evaluate safety and tolerance of WRSs2 by monitoring presence, frequency and severity~     of clinical signs and symptoms. A secondary objective is to evaluate the immune response in~     blood and stool following ingestion of WRSs2 and WRSs3.~   "
170273|NCT01336686|"~     The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to~     placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in~     patients with gout.~   "
170274|NCT01336673|"~     This is a non-interventional, prospective study where no visits or additional interventions~     to the daily practice of the physician will be performed. Glucophage XR® has recently been~     available in Thailand for the treatment of patients with type 2 diabetes. A prospective~     observational study will be valuable to provide information on the day-to-day experience of~     using Glucophage XR® in the management of this patient population. The data may provide an~     insight into the use of Glucophage XR® in routine clinical practice in Thailand.~   "
170275|NCT01336660|"~     This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the~     treatment of North Africa and Middle East scorpions envenomation by reducing the severity of~     envenomation. The primary endpoint is make a comparison between antivenom and placebo groups,~     at 4 hours after study drug, of the number of cases showing improvement in class of~     envenomation.~   "
170276|NCT01336647|"~     Phase 2 study to assess the safety and effectiveness of a product to treat children and~     adults with head lice~   "
170277|NCT01336634|"~     Dabrafenib is a potent and selective inhibitor of BRAF kinase activity. This is a Phase II,~     non-randomized, open-label study to assess the efficacy, safety, and tolerability of~     dabrafenib administered as a single agent and in combination with trametinib in stage IV~     disease to subjects with BRAF mutant advanced non-small cell lung cancer. Subjects will~     receive dabrafenib 150 mg twice daily (BID) in monotherapy treatment and dabrafenib 150 mg~     bid and trametinib 2 mg once daily in combination therapy and continue on treatment until~     disease progression, death, or unacceptable adverse event.~   "
170278|NCT01336621|"~     The purpose of this Phase III study is to assess the long-term safety, tolerability and~     efficacy of flexibly dosed retigabine Immediate Release (IR) as adjunctive therapy in adult~     subjects with partial-onset seizures. In addition, those subjects who successfully completed~     20 weeks of adjunctive treatment with retigabine IR in the parent study, RGB113905, and who~     were thought to have benefitted from treatment will be provided continued access to~     retigabine IR.~   "
170279|NCT01336608|"~     The purpose of the study is to investigate the effect of fluticasone furoate/vilanterol~     Inhalation Powder on arterial stiffness compared with placebo and vilanterol over a 24-week~     treatment period in subjects with COPD and aortic pulse wave velocity of 11.0 m/s or above.~   "
170280|NCT01336595|"~     The purpose of this study is to determine if there are any clinical or radiographic~     differences in cemented total knee arthroplasty with an oxidized zirconium and a~     cobalt-chromium femoral knee component.~   "
170281|NCT01336582|"~     Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel~     formulations in terms of AUC and Cmax.~   "
170282|NCT01336569|"~     The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering~     efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with~     open-angle glaucoma or ocular hypertension.~   "
170317|NCT01336088|"~     The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in~     Parkinson's disease patients following four weeks of dosing.~      The secondary objectives of the study include the evaluation of the efficacy of ADX48621~     compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's;~     the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient~     ability to function, and the evaluation of the effect of coadministration of ADX48621 on~     L-dopa efficacy.~   "
170318|NCT01336075|"~     The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal~     atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive~     thoracoscopic radiofrequency ablation in patients referred for a first time invasive~     treatment for atrial fibrillation.~      The hypothesis is, that mini invasive thoracoscopic radiofrequency ablation as a first time~     invasive treatment is more effective compared to a percutaneous catheter based technique in~     patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least~     one antiarrhythmic drug.~   "
170283|NCT01336556|"~     Background: The oral appliances have been increasingly used in the treatment of primary~     snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment~     options in adults with moderate to severe sleep apnea who did not accept or adapt to~     continuous positive airway pressure (CPAP). It is not well established yet in the literature,~     which patients with mild to moderate OSA will present a good response to treatment with oral~     appliances.~      Objective: To determine a value of CPAP pressure that correlates with a favorable response to~     the use of oral appliance in patients with mild to moderate sleep apnea.~      Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index < 35~     kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15~     events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of~     sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP titration,~     after two months of treatment with oral appliance). Subjective (sleep disorders~     questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective~     (polysomnography) parameters of sleep will be evaluated, besides the quality of life (SF-36),~     mood (POMS), and anthropometric measurements (neck circumference and craniofacial~     characteristic). Good response to treatment with the AIO will be considered as a 50%~     reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of~     sleep.~   "
170284|NCT01336543|"~     This is a pilot phase II study of histology based consolidation chemotherapy in patients with~     inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent~     chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard~     concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be~     offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of~     consolidation with gemcitabine.~   "
170285|NCT01336530|"~     This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre~     trial with 4 parallel treatment groups. The design is adaptive group-sequential with two~     interim analyses, possible sample size re-estimation after the first or second interim~     analysis and drop-the-loser approach. The study design was primarily chosen to show superior~     efficacy of Tepilta® compared to the single components and to placebo. Evaluation of safety~     is a secondary objective.~   "
170286|NCT01336517|"~     The main purpose of this investigation is to evaluate the effect of a lower leg brace on~     walking efficiency and community walking in people who have weakness in one side of the body~     caused after a stroke. The evaluation will consist of several tests that will evaluate~     movement, tightness, balance and sensation in affected leg.~   "
170287|NCT01336478|"~     The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of~     NK cells that will be selected from sibling donors and infused to patients with hematological~     malignancies early following allogeneic stem cell transplantation.~   "
170288|NCT01336465|"~     This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to~     evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe~     ulcerative colitis.~   "
170289|NCT01336452|"~     Hepatocellular carcinoma is the sixth most common malignancy and the third most common cause~     of cancer-related death worldwide. The incidence of HCC is rising in Europe and the United~     States and is expected to continue to increase during the next 2 to 3 decades. The expected~     survival rate is still decimal, especially in patients with advanced HCC. However, in recent~     years, several treatment methods for patients with advanced HCC, including antiangiogenic~     chemotherapy, radiotherapy, concurrent chemoradiotherapy, and DC bead transarterial~     chemoembolization, have been developed. Among these new treatment methods, concurrent~     chemoradiotherapy has also proved to increase patient's survival rate. It is important to~     predict treatment response before treatment or immediately after treatment because there are~     several other treatment options as mentioned above. Recently, there have been several reports~     that MR perfusion parameters such as Ktrans can predict treatment response in cervical cancer~     and colorectal cancer. Therefore the purpose of the investigators study is to evaluate the~     feasibility of predicting treatment response by MR perfusion, contrast enhanced ultrasound~     parameters and biomarkers (IL-6, IL-12 and VEGF) in patients with advanced hepatocellular~     carcinoma who undertake concurrent chemoradiotherapy.~   "
170290|NCT01336439|"~     The purpose of this study is to evaluate the effect of Botulinum toxin type A(Meditoxin®) on~     bruxism using polysomnography and determine which site is most appropriate for injection to~     obtain maximal effects.~   "
170291|NCT01336426|"~     Purpose~      This study is to verify and validate PAD1 as a qualitative serum test which will combine the~     results of multiple assays into a single numeric result, to be determined by evaluation of~     the study data.~      PAD1 is an automated software device (PADCalc) that incorporates specific and multiple~     biomarker values found in human blood, and generates a score (PAD1 score) using a fixed~     formula implemented within the PADCalc software. The PAD1 score is a result with a high or~     low probability of PAD.~      PAD1 will be submitted to FDA as a 510(k) for in vitro diagnostic use in conjunction with~     clinical assessment, based on factors such as age, diabetes, smoking, and vascular laboratory~     tests (including the ABI), as an aid towards further evaluation of patients who meet the~     enrollment eligilbility criteria.~      Eligibility It is indicated for women and men considered at risk for PAD who meet the~     following criteria: a history of smoking and/or diabetes and are age 50 years or older, or 70~     years of age or older. PAD1 is an aid to further assess the likelihood of the presence of PAD~     when used in conjunction with clinical assessment and vascular laboratory tests.~   "
170319|NCT01336062|"~     Gastric cancer have poor prognosis and majority of patients resistant to 5-FU/DDP based~     first-line chemotherapy in China. There was no recommended second-line chemotherapy for~     advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound~     Paclitaxel (Abraxane，ABI-007) has good convenience to use and been approved in breast cancer~     in many countries. The investigator then initiated a prospective phase Ib/IIa clinical trial~     with nab-paclitaxel plus TS-1 as the second-line treatment in advanced gastric cancer to~     observe the safety and efficacy.~   "
170397|NCT01335048|"~     The purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an~     adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable~     patients with high on-treatment reactivity according to a point-of-care platelet function~     assay.~   "
170292|NCT01336413|"~     Purpose: Mild traumatic brain injury (TBI) is extremely common among Operation Enduring~     Freedom/Operation Iraqi Freedom (OEF/OIF) era Veterans. Mild TBI is frequently accompanied by~     post-traumatic stress disorder (PTSD) and depression symptoms, co-occurring disorders that~     contribute to increased disability and decreased quality of life. Neuroactive steroids (NS)~     represent promising pharmacological candidates for intervention for these diverse symptom~     domains, since a number of these molecules demonstrate pronounced neuroprotective and~     neurotrophic properties. The NS pregnenolone (PREG) is a logical therapeutic option, since it~     enhances learning and memory and also increases myelination in rodent models. Further,~     decreases in PREG have been associated with depressive symptoms, and PREG is also metabolized~     to allopregnanolone (ALLO), an anxiolytic downstream NS that is decreased in PTSD. ALLO also~     enhances neurogenesis in rodents. The investigators thus propose an randomized controlled~     trial (RCT) in OEF/OIF era Veterans with mild TBI.~      Methodology: The design of this study will be randomized, placebo-controlled, double-blind.~     Trial duration will be 10 weeks, consisting of a 2-week placebo lead-in period for all~     subjects, followed by 8 weeks of treatment with either pregnenolone or placebo. The primary~     cognitive outcome measure will be executive functioning (as assessed by the Tower of London~     test), and the primary behavioral outcome measure will be PTSD Cluster D symptoms (as~     assessed by the Clinician-Administered PTSD Scale, CAPS). The investigators will also~     determine if PREG administration in OEF/OIF Veterans with mild TBI increases downstream ALLO~     and/or other GABAergic NS levels, and the investigators will identify the specific metabolism~     profile of PREG following eight weeks of treatment with this neurosteroid.~      Anticipated Findings: The investigators hypothesize that treatment with PREG in OEF/OIF era~     Veterans with mild TBI will significantly improve executive functioning compared to the~     placebo condition. The investigators also predict that treatment with PREG will decrease~     Cluster D PTSD symptoms compared to treatment with placebo.~   "
170293|NCT01336400|"~     The investigators previously developed approaches to SNP-, CNV- and haplo-type single human~     cells (Vanneste et al. 2009, Nature Medicine). These methods open the possibility to be~     developed into a novel generic diagnostic technique which broadens the spectrum of~     disease-alleles that can be selected against during preimplantation genetic diagnosis (PGD)~     and which enables to help those couples that cannot be supported by PGD yet. PGD is the~     genetic analysis of a single blastomere from an in vitro fertilized (IVF) embryo and it is~     offered to couples to avoid the transmission of heritable genetic disorders to their~     offspring. PGD analyses are performed for (1) autosomal dominant or recessive monogenic~     diseases, (2) X-linked disorders and (3) chromosomal aberrations that may result in aneuploid~     conceptions. This novel method is likely to outperform and hence, replace current techniques~     for preimplantation genetic diagnosis. In this project the investigators will bring the~     technology from a proof-of-principle to the clinical application. To this end the~     investigators will make computational improvements for accurate single blastomere SNP-, CNV-~     and haplo-typing and perform a large validation study. For the validation studythe~     investigators will analyse the genomes of the blastomeres derived from 60 spare embryos of~     different origin: (1) Embryos diagnosed as genetically abnormal using current PCR- and~     FISH-protocols. (2) Embryos diagnosed as normal for the investigated region using current~     PCR- and FISH-protocols, but not of sufficient quality to be transferred or frozen. (3)~     Embryos of the sex that is selected against following PGD based sex-selection, or embryos of~     the sex that is selected for but of insufficient quality to be transferred or frozen. (4)~     Embryos that were not biopsied in a PGD cycle since they suffer a slight growth delay. This~     validation study will allow us to evaluate (1) the clinical validity (false positive and~     negative rate) and (2) clinical applicability (in terms of ease of use, success rate, etc.).~     In addition, it will bring us essential further fundamental insights in the origins and~     mechanisms of chromosomal instability operating during early embryogenesis and its~     consequences for clinical applications of PGD. Finally, following the validation study, this~     project will clinically implement the technique to treat 10 families.~   "
170294|NCT01336387|"~     This randomized phase I trial studies the side effects and the best dose of retinoid 9cUAB30~     in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from~     forming. The use of retinoid 9cUAB30 may keep cancer from forming.~   "
170295|NCT01336374|"~     The purpose of this study is to determine the impact of vacant lot greening on perceptions of~     safety and violence for residents living around the lots. We hypothesize that people living~     around lots that are greened will have improved perception of safety.~   "
170296|NCT01336361|"~     The purpose of this study is to explore emerging physical therapy practice in palliative~     care, and the perceptions of physical therapists regarding their care of the functionally~     dependent elderly, including: (1) the role and utilization of palliative care intervention in~     current practice, (2) current and potential goal-setting practices which may relate to~     palliative care, and (3) therapists' awareness of cultural and psychosocial issues in patient~     care.~   "
170297|NCT01336348|"~     This is a single-centre, open-label prospective randomized pharmacodynamic investigation of 2~     antiplatelet regimens in patients undergoing coronary intervention for ST segment elevation~     myocardial infarction(STEMI):~        1. Tirofiban bolus only or bolus followed by 2 hour infusion on top of 600 mg clopidogrel~          or 60 mg prasugrel.~        2. Prasugrel given at 60 mg.~   "
170298|NCT01336335|"~     Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular~     disease even in the absence of hypertension. However, there are few data regarding the impact~     of OSA on the sympathetic system in apparently normotensive patients with OSA as well as the~     impact of treatment with continuous positive airway pressure in different sites of activation~     (heart, peripheral nerves and circulating catecholamines)~   "
170299|NCT01336322|"~     The goal of the present research is to compare the effects of treatment with metformin and~     sitagliptin, alone or in association, in women with previous gestational diabetes to evaluate~     the impact of the two drugs on beta-cell function. The study results may contribute to give a~     rational approach for future investigations.~   "
170300|NCT01336309|"~     This study comprises 4 phases designed to systematically develop and test a reliable, valid~     and useful quantitative measure of the components and dimensions of yoga; each phase builds~     on the previous phase. Phase I aims to gain a comprehensive understanding of the relevant~     aspects of yoga therapy and develop a large pool of potential questionnaire items by~     conducting a thorough literature review and focus groups with yoga teachers and students.~     These data will be analyzed using rigorous qualitative methods to identify key conceptual~     dimensions associated with yoga interventions. Phase II will develop a prototypic~     questionnaire to assess yoga therapy by refining and honing information from Phase I and~     conducting cognitive interviews to further develop this instrument. Phase III will pilot test~     the measure in a field observation of yoga students and use factor analysis and item response~     theory to select the best items per dimension and to reduce the number of items in the~     measure. Phase IV will collect data on the new instrument and test the psychometric~     properties of the questionnaire (i.e., reliability and validity using data collected in~     Phases III and IV).~   "
170301|NCT01336296|"~     This study is specifically designed to determine whether the initiation of Myfortic 2 weeks~     prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy~     in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to~     Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction~     starting at the time of transplant in kidney transplant recipients.~   "
170348|NCT01335685|"~     The purpose of this phase 1/2, open-label study was to evaluate the effect of oral~     formulation of Ixazomib when added to standard melphalan and prednisone (MP) treatment. Both~     phases of the study included participants who had newly diagnosed multiple myeloma and were~     ineligible for high-dose therapy plus stem cell transplantation because of age (≥65 years of~     age) or coexisting conditions and for whom standard MP treatment was indicated.~   "
170302|NCT01336283|"~     Aims: To prove the benefits of an specific strength training program in COPD patients~     compared to those achieved with the traditional endurance training. We will assess which is~     the proper training modality and which of them is the most beneficial according to the~     features of the patient to whom it is applied.~      Subjects and Methods: We will study 66 patients diagnosed of COPD with a moderate-severe~     obstruction (FEV1<60%) and clinically symptomatic. The monitoring will be done for 3 moths.~     Patients will be differentiated between COPD with predominant chronic bronchitis and COPD~     with predominant emphysema, with regard to clinical, functional and radiological criteria.~     After stratification of the sample, patients will be prospectively assigned to three groups~     of 22 patients each: a) Endurance training group, on cycle ergometer at a workload of 70%~     VO2max. b) Strength training group, with 5 different weightlifting exercises (4 sets of 6-8~     repetitions). c) Mixed training group, with half the time dedicated to each type of training.~     Training will be developed during 12 weeks, three times per week, in 40 minutes sessions.~     Analysed variables, at the beginning and at the end of program will be: Chest X-ray, basic~     blood analyses, electrocardiogram, simple spirometry and bronchodilator test, blood gases,~     static pulmonary volumes, diffusion measurement and respiratory muscle pressure. Muscle~     strength will be assessed by means of 1RM test and the Myometer® dynamometer. Using the~     muscle skeletal ultrasound, we will control changes in muscle fibre size. Maximal and~     submaximal exercise tests on cycle ergometer will be also performed, so as a walking test~     (shuttle walking test). At last, we will assess treatment effect on dyspnea (Mahler`s test)~     and quality of life (CRDQ).~      Hypothesis: A strength training program would significantly increase peripheral muscle power.~     This type of training would mainly have effect on the predominant emphysema COPD patient,~     where the important weight lost causes a decrease in muscle strength.~   "
170303|NCT01336270|"~     Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with~     an anti-tumoral specificity. The aim of the study is to analyse at different stages of the~     disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular T~     lymphocytes, NK cells and macrophages), the role of inhibitor receptors on in situ~     immunosuppression, and potential modulation by medical treatments such as dacarbazine.~   "
170304|NCT01336257|"~     Clinical decision support has been shown to improve the performance of screening tests;~     however, few studies have documented direct clinical benefit resulting from the increased~     screening promoted by clinical decision support systems.~      The purpose of this study was to determine if a standards-based, sophisticated decision~     support system could not only promote additional breast cancer screening, but also detect~     significantly more breast cancer~   "
170305|NCT01336244|"~     The purpose of the study is to evaluate the safety and tolerability of multiple ascending~     oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and~     to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple~     oral administrations.~   "
170306|NCT01336231|"~     Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients~     treated with anti-angiogenic for metastatic kidney cancer~   "
170307|NCT01336218|"~     The purpose of this study is to investigate the drug interaction between fostamatinib and~     rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib~     when administered alone and with rifampicin in healthy subjects~   "
170308|NCT01336205|"~     The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118~     treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.~   "
170309|NCT01336192|"~     Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death.~     Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer~     (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate~     measure. The standard treatment for this patient population consists of third generation~     platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until~     disease progression (PD) before the administration of second-line and third-line systemic~     anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a~     selected subgroup with an improved overall prognosis.~      Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC~     without PD after first-line chemotherapy has been confirmed to improve progression free~     survival (PFS) and overall survival (OS) significantly compared with placebo in two large~     randomized controlled studies. However, continuation gemcitabine maintenance therapy in this~     setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS~     improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine~     maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1~     and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in~     China.~   "
170310|NCT01336179|"~     The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and the~     toothbrushes on plaque removal and gingival health.~   "
170311|NCT01336166|"~     The aim of this study is to investigate the long-term immunogenicity and safety of the~     inactivated split-virion vaccine after one immunization.~   "
170312|NCT01336153|"~     To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese~     Medicine on motor recovery after ischemic stroke.~   "
170313|NCT01336140|"~     The routine administration of 75 mg of intravenous aminophylline in patients with severe~     chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can~     reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.~   "
170314|NCT01336127|"~     The purpose of this study is to determine the effectiveness of occupational therapy in~     Parkinson's disease.~   "
170315|NCT01336114|"~     Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the~     spine. In case of progressive curve deformity, the use of spinal bracing remains the standard~     non operative treatment of moderate AIS. Most of the time, the different types of braces~     don't take into account the individual biomechanical properties of each patient's spine.~     Actually, it is essential to better understand the effect of the loads applied on the trunk~     and on the spine, and a 3D geometrical modelisation of these components is essential. Many~     studies have been publishing concerning the use of radiographs for the geometrical~     reconstruction of the spine, and more recently the EOS system. But even then, it is still~     necessary to obtain an important number of geometrical data and discretisation is still a~     long procedure.~   "
170316|NCT01336101|"~     The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in~     patients with superficial femoral/ popliteal artery disease.~      100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and~     shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time~     the stent will be placed, and follow-up visits at 6 and 12 months.~      Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will~     be efficacious in patients with Superficial Femoro/Popliteal Artery disease.~   "
170320|NCT01336049|"~     Nimotuzumab, as one new agent used in advanced esophageal carcinoma, has been shown to be~     effective and safe in some studies with head-neck cancers. Advanced esophageal carcinoma have~     poor prognosis and majority of patients resistant to chemotherapy in China. In the~     investigators phase II clinical trial proceeded before,the combination of paclitaxel with~     cisplatin showed good tolerance and efficacy to esophageal carcinoma. The investigators then~     initiated a prospective phase II clinical trial with Nimotuzumabplus paclitaxel/cisplatin as~     the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of~     the combination.~   "
170321|NCT01336036|"~     This is a descriptive clinical research aiming:~        -  To describe the clinical spectrum and clinical characteristics of community acquired~          pneumonia (CAP) in patients admitted to hospital~        -  To identify the etiology of CAP and the antibiotic sensitivity of the isolated organisms~        -  To identify the risk factors that influence the severity of CAP~   "
170322|NCT01336023|"~     This trial is conducted globally. The aim of this trial is to compare the efficacy and safety~     of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide~     (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment~     with metformin or metformin + pioglitazone throughout the entire trial.~   "
170323|NCT01336010|"~     To determine whether response guided treatment with pegylated interferon +/- ribavirin is~     effective for the treatment of recently acquired hepatitis C infection. Response guided~     treatment is when the length of treatment is determined by how quickly you respond to the~     treatment.~   "
170324|NCT01335997|"~     This study is being done to find out if tablets containing extended release (ER) niacin,~     laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin~     and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol~     and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g /20 mg is~     equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing low-density~     lipoprotein cholestrol (LDL-C).~   "
170325|NCT01335984|"~     This is a multi-centered, randomized, parallel group, interventional & open label clinical~     trial accessing efficacy of intervention effect by smart care system over existing treatment~     group for lowering blood pressure of hypertension patients taking anti-hypertension drug.~   "
170326|NCT01335971|"~     Evidence from investigators' group has shown that chronic obstructive pulmonary disease~     (COPD) patients have impairment of antioxidant defenses which are caused by a defect in~     activity of Nrf2. This trial focuses on sulforaphane, a derivative of cruciferous vegetables,~     which is a potent stimulator of Nrf2 activity. The investigators want to investigate whether~     ingestion of sulforaphane by COPD patients will increase Nrf2 activity and expression of~     downstream antioxidants. Accordingly, the investigators are conducting a placebo-controlled~     randomized proof of principle trial of two oral doses of sulforaphane, 25 and 150 micromoles,~     for 4 weeks in 90 COPD patients. The investigators' goal is to establish a safe and tolerable~     dose of sulforaphane that effects in vivo antioxidants via Nrf2, then the investigators will~     have a novel candidate treatment for longer-term efficacy trials.~   "
170327|NCT01335958|"~     This is a Phase I, multi-center, open-label, dose-escalation study of DMUC5754A administered~     as a single agent by intravenous (IV) infusion to patients with platinum-resistant ovarian~     cancer or unresectable pancreatic cancer.~   "
170328|NCT01335945|"~     CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of~     epigastric/abdominal pain associated with pancreatic cancer.~   "
170329|NCT01335932|"~     To evaluate whether administration of ganciclovir reduces serum IL-6 levels (i.e. reduction~     between baseline and 14 days post-randomization) in immunocompetent adults with severe sepsis~     or trauma associated respiratory failure.~      Primary Hypotheses:~      - In CMV seropositive adults with severe sepsis or trauma , pulmonary and systemic CMV~     reactivation amplifies and perpetuates both lung and systemic inflammation mediated through~     specific cytokines, and contributes to pulmonary injury and multiorgan system failure,~      AND~      - Prevention of CMV reactivation with ganciclovir decreases pulmonary and systemic~     inflammatory cytokines that are important in the pathogenesis of sepsis and trauma related~     complications.~   "
170330|NCT01335919|"~     The purpose of this study is to evaluate hemoglobin (Hgb) measurement by Masimo-developed~     pulse co-oximetry in pediatric patients weighing less than 3 kilograms (Kg).~   "
170331|NCT01335906|"~     Study objectives: to evaluate the effects of information about benefits and risks of~     mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear~     of cancer, anxiety, and conflict decision. Study hypothesis: information about benefit and~     risks of mammography screening increases the women´s knowledge of it; allows women to make an~     informed decision on whether to stop or continue the screening program, changing the actual~     participation rate; anxiety and fear are not increased. Design: randomized controlled~     clinical trial with non-pharmacological intervention. Subjects and setting of study: women~     referred to mammography screening in the District Bay of Cádiz-La Janda. Interventions:~     random assignment of women in two arms according to the information provided. Control arm is~     the standard information; it consists of receiving information normally provided to women~     attending the screening program for breast cancer. Intervention arm is the experimental~     information and consists of receiving accurate verbal and written information about the~     benefits and real risks of mammography screening programs by a physician investigator.~     Determinations: knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict~     decision.~   "
170332|NCT01335893|"~     Our specific aim is to determine if Indocyanine Green (ICG) administered intraoperatively and~     imaged using our camera will aid in the identification of a suspected lung nodule.~   "
170333|NCT01335880|"~     This study tests two different incentive mechanisms to induce members of a particular urban~     senior center to attend more exercise classes. Coupons for future use are given to~     participants who attend an exercise class and will be redeemable within either a one week or~     three month time period, depending on which experimental group the participant is assigned~     to. Frequency of exercise class attendance at the end of 2 months will be the primary~     outcome.~   "
170334|NCT01335867|"~     The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and~     alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the~     treatment of seizures. It has not been proven to be effective for the treatment of alcohol or~     cocaine dependence.~   "
170335|NCT01335854|"~     The proposed research will evaluate new approaches to improving the ability of patients with~     obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive~     airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with~     newly diagnosed OSA who are being initiated on CPAP treatment will be assigned to one of 3~     groups: usual care, usual care with web-based access to daily CPAP adherence, and usual care~     with web-based access to daily CPAP adherence and a financial incentive to use CPAP at least~     4 hours/day in the first week of treatment. Measures of CPAP use, daytime sleepiness, and~     quality of life will evaluate whether patients provided web-based access to their daily CPAP~     adherence with and without financial incentive will have greater objectively measured average~     daily hours of CPAP use and greater improvement in functional outcomes following 3 months of~     treatment compared to patients receiving usual care.~      The results will test the hypothesis that these behavioral interventions will improve patient~     adherence to CPAP during the critically important first week of treatment when many patients~     are deciding whether or not to use CPAP and that this initial level of adherence will be~     maintained over the long term despite withdrawal of the financial incentive.~   "
170336|NCT01335841|"~     The purpose of this study is to demonstrate an optimization of the establishment of~     orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and~     navigation system versus conventional method involving anatomical landmarks and 2D~     fluoroscopy.~   "
170337|NCT01335828|"~     Define an ultrasound/elastography benignity criteria in strategy management of a patient~     population carries one or more thyroid nodules.~   "
170338|NCT01335815|"~     Summary: The purpose of the study is to prove if the biomarker high sensitive troponin T~     (hsTnT) and the biomarker of endogenous stress copeptin can serve as surrogate parameter of~     prognosis in patients with elective knee and hip total endoprosthesis.~   "
170339|NCT01335802|"~     Studies have demonstrated a relationship between subclinical hypothyroidism and obstetrics~     complications like preterm delivery, pre-eclampsia, placental abruption and stillbirth.~     Subclinical hypothyroidism and positive thyroperoxidase antibodies (TPOab) may increase the~     risk of early spontaneous abortion before 12 weeks of gestation. But there is not a consensus~     if the prevalence of TPOab should be treated before and during pregnancy when the level of~     thyroid-stimulating hormone (TSH) is normal.~      Thyroid hormones are regulators of the mitochondrial activity and our research group has~     previously shown that subclinical hypothyroidism affects mitochondrial activity.~      The hypothesis:~      Subclinical hypothyroidism causes early spontaneous abortion and or complications in~     pregnancy like pre-eclampsia because of mitochondrial dysfunction~   "
170340|NCT01335789|"~     The purpose of this study is to evaluate how people who frequently use marijuana respond to a~     stressful task, and if a medication (oxytocin) affects this response.~   "
170341|NCT01335776|"~     Sleep disturbance in cancer patients is often overlooked despite its documented high~     prevalence and negative impact. There are few empirically validated non-pharmacological~     treatments for insomnia and many patients are unwilling to rely on sleeping medications. This~     study will determine whether Mindfulness-Based Stress Reduction (a program that teaches~     meditation and yoga) produces equivalent results with the additional benefits of reduced~     stress and mood disturbance, to an already established treatment for insomnia,~     Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for~     insomnia beyond what is currently available and improve quality of life for millions of~     cancer survivors.~   "
170342|NCT01335763|"~     Background: Approximately 1.9 million Canadians are living with diabetes and this is~     estimated to increase by 75% over the next few decades. Pharmacists are front line primary~     healthcare professionals who see patients with diabetes frequently and in Alberta, they have~     been allowed to prescribe medications and order laboratory tests. As such, pharmacists could~     systematically identify poorly controlled diabetes patients and provide greater access to~     diabetes interventions to improve blood sugar control.~      Objective: The aim of this study is to determine the effect of a community pharmacist~     intervention on blood sugar control in individuals with poorly controlled diabetes.~      Project description:~      100 adults with type 2 diabetes and uncontrolled blood sugar will be defined by the~     participating pharmacists. Blood sugar control is going to assessed using hemoglobin A1c test~     (a blood test to measure individual's blood sugar control over the last 3 months). This test~     requires obtaining a blood spot from the patient which will be obtained by pricking his/her~     fingertip. Based on the hemoglobin A1c test result the pharmacist will assess the patient's~     need for insulin glargine, if the patient needs insulin glargine the pharmacist is going to~     prescribe it for him/her and educate him/her on its use. Patients are going to be followed up~     closely by the pharmacists for 6 months with regular updates to the patients' family~     physicians. This multi-centre study should demonstrate pharmacists' ability to improve~     glycemic control and improve access to care.~   "
170343|NCT01335750|"~     This study is a clinical comparison of the biocompatibility of several multipurpose~     solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution~     among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one~     research site.~   "
170344|NCT01335737|"~     The purpose of this study is to test the hypothesis that aerobic exercise leads to~     attenuation of the inflammatory response to lipopolysaccharide (LPS) stimulation.~   "
170345|NCT01335724|"~     The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel~     compared with placebo applied four times a day in subjects with acute neck pain.~   "
170346|NCT01335711|"~     To explore the effect on early viral kinetics and viral load, and to determine safety,~     tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m.~     in combination with electroporation followed by standard of care (SOC) in treatment naïve~     chronic HCV genotype 1 patients.~   "
170347|NCT01335698|"~     The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a~     regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse~     transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.~   "
170424|NCT01334684|"~     Our general aim is to investigate whether messenger RNA (mRNA) and/or microRNA (miRNA)~     expression profiles in white blood cells, predict metformin monotherapy efficacy in patients~     with type 2 diabetes.~   "
170425|NCT01334671|"~     The purpose of this study is to evaluate the clinical effect of intensive statin therapy~     before emergency PCI in patients with STEMI.~   "
170349|NCT01335672|"~     An estimated three million people are affected by chronic obstructive pulmonary disease~     (COPD) in the UK, giving it a prevalence of 1.5% of the population in 2007/08. COPD accounts~     for approximately 30,000 deaths each year in the UK and is an important co-morbidity in those~     dying from other smoking related diseases, most commonly ischaemic heart disease and lung~     cancer. The National COPD audit showed a very high level of co-morbidity, the association~     with cardiovascular disease being particularly strong with 51% of patients with~     cardiovascular disease having been admitted for COPD within the preceding 24 months. Patients~     with COPD are at increased risk of myocardial infarction compared to the general population.~     Although this increase in cardiovascular risk exists, it is not clear is whether survival~     after myocardial infarction is different in patients with and without COPD and what factors~     contribute to this survival difference. Differences in survival may arise due to differences~     in prescribing certain drugs such as beta-blockers, differences in prevalence of risk factors~     (e.g. current smoking status) or increased COPD events such as exacerbations which themselves~     are associated with increased mortality.~      The investigators primary aim is to investigate whether survival after first myocardial~     infarction is shorter in patients with COPD than those without COPD and to establish reasons~     for these differences in survival.~   "
170350|NCT01335659|"~     The investigators studied the relations between coronary angiography (CAG), intravascular~     ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.~   "
170351|NCT01335646|"~     The objective of this study is to determine if surgery is superior to non-operative care for~     sciatica caused by a lumbar disc herniation. This study will include patients that have had~     severe sciatica for greater than 4 months which reflects the wait time of the Canadian health~     care system. This study is an opportunity to make an important contribution to medical~     science as there is no top tier evidence for or against this highly prevalent surgery.~     Although there have been several recent randomized trials in the field, all have been marred~     by a large number of patient crossing over from non-operative to operative treatment. Due to~     the wait for spine surgery, the Canadian system has a built-in delay that prevents such a~     cross over of patients. This study capitalizes on this unique opportunity to perform a high~     caliber surgical trial. Patients consenting to be in the study will be randomly assigned to~     expedited surgery within three weeks or standardized non-operative care while they wait on~     the surgeons list for consultation and then surgery (minimum wait of 9 months). The study~     will assess pain, function, quality of life, satisfaction, and work status to determine if~     one treatment is superior.~   "
170352|NCT01335633|"~     The study will entail cognitive assessment of a single cohort of patients with Multiple~     Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no~     intervention or control group. Each participant will have a caregiver capable of responding~     to a brief report of observations regarding neuropsychological skills and abilities in the~     patient.~   "
170353|NCT01335620|"~     This is a phase I, open label, prospective, one phase pharmacokinetic and observational~     study.~      Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be~     receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence~     of previous HIV- resistance mutations on genotypic resistance testing.~      At baseline, subjects will switch antiretroviral therapy to:~        -  tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus~        -  raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24~          hour pharmacokinetic visit.~      Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits~     that will include standard safety parameters. Assessment of cardiac biomarkers at baseline~     and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and~     on day 180 will also be undertaken.~      Following completion of this study, subjects will recommence their usual antiretroviral~     treatment regimen and attend for a study follow up visit.~   "
170354|NCT01335607|"~     The purpose of this study is to:~        -  Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and~          tablet prototype test formulation)~        -  Compare the amount of study drug that is in the blood after taking either the capsule~          form of the drug or the tablet form of the drug while fasting.~        -  Determine the amount of study drug that is in the blood after eating a meal.~        -  Evaluate the safety of the tablet form of samatasvir in healthy people.~   "
170355|NCT01335594|"~     The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is~     associated with deviant pharyngeal swallowing function, using clinical, endoscopical and~     manometric evaluation.~   "
170356|NCT01335581|"~     The purpose of this study is to evaluate the RevLite laser in the treatment of refractory~     mixed type melasma.~   "
170357|NCT01335568|"~     This clinical investigation of the hepatocyte matrix implant is an evaluation blinded~     non-randomized and monocentric pilot study of Phase I, which is conducted as a therapeutic~     investigation. Randomization is not possible due to ethical and practical reasons. This study~     has already been approved in Switzerland and has been adapted to Indonesian Law and disease.~      This new treatment procedure has already been successfully used on the basis of compassionate~     use in Germany. The hepatocyte matrix implant is a new patented procedure consisting of~     bio-matrix technology. A formaldehyde-free special matrix consisting of self-dissolving~     polymers is applied as a carrier substance and is cultivated with human autologous cells~     using a special technique. Clinically the bio artificial liver replacement tissue for~     patients with end-stage hepatic disease has been developed as a first application. In this~     procedure autologous hepatocytic tissue and pancreatic tissue is removed (liver resection and~     pancreatic biopsy) from the patient in a first surgical procedure. The tissue is sent to a~     specialized Cell Culture Laboratory. The laboratory is GMP certified for this procedure. The~     cells are processed according to SOPs in a special perfusion procedure and prepared on~     several platelets of matrices (platelets of 20 mm diameter and 4mm thickness). After~     completion of the laboratory process the bio tissues are implanted into the mesentery of the~     small intestine during a second operation. The cells are growing controlled on the matrix,~     take on the capillaries of the patient and thus connect to the blood circulation. The~     implanted cells multiply by a specific factor and independently take over the metabolic~     function of the original liver after two to four weeks. In the following process the carrier~     matrix dissolves completely and implanted cells develop into liver cell tissue.~   "
170358|NCT01335555|"~     It is important to assess patients' fitness for major cancer surgery which carries a high~     risk of mortality. Patients with poor heart and lung function have a higher risk of death~     after major cancer surgery. Cardiopulmonary exercise testing, CPET, is an objective measure~     of patients' fitness. Most patients, before surgery to resect their cancer, undergo a period~     of chemotherapy. Chemotherapy often regresses the cancer but also has adverse effects on cell~     function. Our hypothesis is that chemotherapy alters patient fitness, as assessed by CPET,~     prior to major cancer surgery. Participating patients will undergo fitness testing by CPET~     before and after their chemotherapy, prior to their surgery.~   "
170359|NCT01335542|"~     There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some~     patients receive an epidural analgesia, a femoral nerve block and pills for pain. More~     recently, some surgeons have replaced femoral nerve blockade with peri-articular injections.~     These patients receive a peri-articular injection (injection of pain medication around the~     knee), pills for pain and a pain patch on the skin. The purpose of this research project is~     to find out if one of these ways to treat pain is better than the other. The investigators~     will look at this question in many ways, but the main way is how long it takes for you to be~     judged ready for discharge from the hospital.~   "
170360|NCT01335529|"~     The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected~     patients are non responders after 48 weeks of the current standard-of-care with~     Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of~     Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy~     in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV~     co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks~     of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to~     improve the response rate of the re-treatment of hepatitis C in these patients.~      The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in~     combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and~     chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects~     will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR) defined~     as undetectable HCV-RNA at Week 24 after the end of therapy.~   "
170361|NCT01335516|"~     Terlipressin is an effective and safe treatment for bleeding caused by rupture of oesophageal~     varices, which are life-threatening complications of liver cirrhosis.~      Oesophageal varices are abnormal dilatation of veins occurring in the lower oesophagus, which~     can develop in patients with cirrhosis. Bleeding caused by rupture of these varices is a~     life-threatening complication with mortality between 20-50%.~      Such bleeding can be treated with drug therapy and/or endoscopic; endoscopic therapy consists~     of a flexible tube equipped with a camera at the terminal end, allowing for visualizing and~     treating the oesophageal varices.~      In this study, investigators will evaluate the safety and efficacy of terlipressin -~     Glypressin 1 mg, powder and solvent for solution for injection.~      The non-interventional observational study Follow-up of Glypressin (terlipressin) clinical~     efficacy in the treatment of bleeding oesophageal varices aims to demonstrate that~     administration of Glypressin (terlipressin 1 mg) controls the bleeding in such patients.~   "
170362|NCT01335503|"~     The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in~     the stomach and how much gluten enters the small intestine. A second question is whether the~     caloric density of a meal can influence the efficacy of AN-PEP breakdown.~   "
170363|NCT01335490|"~     The purpose of the study is to understand how cooking might affect the health of pregnant~     women and their babies.~      The goal of the research is to determine whether, interventions in decreasing exposure to~     smoke from cook stoves can bring about a significant change in the indoor air pollution~     levels and health of communities in Ghana.~      Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will lead~     to a significant increase in average birth weight in newborns.~      Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate of~     severe acute lower respiratory disease during the first 12 months of life.~   "
170364|NCT01335477|"~     Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in~     scarring of the lung and there is a high unmet medical need for effective treatment to halt~     lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the~     death rate.~      In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of~     treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of~     patients treated with high dose of BIBF 1120 compared to placebo.~      Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of~     BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will~     be conducted as a prospective, randomised design with the aim to collect safety and efficacy~     data.~      Respiratory function is globally accepted for assessment of treatment effects in IPF~     patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is~     part of the usual examinations done in IPF patients.~   "
170365|NCT01335464|"~     Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in~     scarring of the lung and there is a high unmet medical need for effective treatment to halt~     lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the~     death rate.~      In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of~     treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of~     patients treated with high dose of BIBF 1120 compared to placebo.~      Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of~     BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will~     be conducted as a prospective, randomised design with the aim to collect safety and efficacy~     data.~      Respiratory function is globally accepted for assessment of treatment effects in IPF~     patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is~     part of the usual examinations done in IPF patients.~   "
170366|NCT01335451|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     AZD5213 in healthy young and elderly Japanese subjects~   "
170367|NCT01335438|"~     The purpose of this study is to determine if there are any clinical or radiographic~     differences in cemented and cementless fixation in total knee replacement.~   "
170380|NCT01335269|"~     The primary objective of this trial is to determine the safety and tolerability of BI 853520~     monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for~     further trials in the development of this compound.~      Secondary objectives are~        -  determination of the pharmacokinetic (PK) profile;~        -  exploratory pharmacodynamic analysis; and~        -  collection of preliminary data on anti-tumour efficacy.~   "
170381|NCT01335256|"~     Clinical study to determine safety, tolerability, and maximum tolerated dose of BAY1000394~     given in 4 week on / 2 week off schedule to patients with advanced solid tumors~   "
170368|NCT01335425|"~     In clinical practice language impairment is frequently reported in association with nocturnal~     epileptiform activity. There is a spectrum of epileptic conditions that are characterized by~     nocturnal epileptiform activity. From mild to severe this spectrum involves: Rolandic~     epilepsy (RE), nocturnal frontal lobe epilepsy (NFLE), Landau-Kleffner syndrome (LKS) and~     electrical status epilepticus during slow wave sleep (ESES). The exact characteristic of the~     relationship between nocturnal epileptiform activity and language impairment is yet to be~     explored. The investigators suggest that nocturnal epileptiform EEG discharges and nocturnal~     epileptic seizures during development will cause diseased neuronal networks that involve~     language. The diseased neuronal networks are less efficient compared with normal neuronal~     networks.~      Objective: Identification of a diseased neuronal network characteristic in children with~     nocturnal epileptiform activity, which can explain language impairment in these children. For~     this the investigators will use functional magnetic resonance imaging (MRI) to analyse brain~     activity and diffusion weighted MRI to investigate white matter connectivity.~   "
170369|NCT01335412|"~     This is an active electronic surveillance using data from the Defense Medical Surveillance~     System (DMSS) to detect and characterize serious, rare adverse events occurring within 42~     days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military,~     to detect adverse events that occur more frequently after IXIARO and to electronically follow~     up pregnancies during or shortly before which IXIARO was administered.~      There will be no intervention and no individuals contacted.~   "
170370|NCT01335399|"~     The purpose of the study is to determine whether the addition of Elotuzumab to~     Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)~   "
170371|NCT01335386|"~     This is a randomised, assessor-blind, multi-centre pilot study to investigate the comparative~     safety and efficacy of KLYX and glycerine enema in the symptomatic treatment of constipation~     in Chinese patients.~   "
170372|NCT01335373|"~     Vaginitis is the most common gynecologic diagnosis in the primary care setting. In~     approximately 90 percent of affected women, this condition occurs secondary to bacterial~     vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection.~      Neo-Penotran Forte is registered for treatment of these most common vaginal infections.~     Efficacy and safety of this product is already established, and this observational study was~     designed to learn more about practical use of Neo-Penotran® Forte in real life setting.~   "
170373|NCT01335360|"~     This study would be a prospective cohort study, stratified by weight. Patients who are stable~     on nevirapine for at least 3 months prior to study entry, but no more than 1year will be~     recruited. For 1 week, subjects will take their morning dose of nevirapine in the clinic (and~     be observed taking it), and given their evening dose to take at home. Subjects will need to~     record the date and time they take their evening dose. At the end of the week, the subjects~     will be sequestered at the clinic for blood draws for a 12hr pharmacokinetic sampling. They~     will not be brought back in at 24hrs as they will need to be redosed after 12hrs. They will~     have Liver Function Tests (LFT's) and other labs drawn at study entry, and one month after~     the end of study. Pharmacokinetic levels will be analyzed using standard mathematical models,~     and Area Under the Curve (AUC), Maximum concentration (Cmax), and Minimum Concentration~     (Cmin) will be compared between groups.~   "
170374|NCT01335347|"~     The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine~     to prevent avian influenza. Volunteers will receive either one or two doses of research~     vaccine or placebo as part of this study.~   "
170375|NCT01335334|"~     The proposed open-label one arm before-after clinical trial will assess the efficacy of a~     14-day quadruple therapy containing 420mg of bismuth subcitrate potassium, 375mg of~     metronidazole, 375mg of tetracycline hydrochloride (Pylera® packs from Axcan Pharma) and 20mg~     of omeprazole in eradicating H. pylori infection in 50 asymptomatic adults in El Paso, Texas.~     As part of the study we will obtain specimens for culture of H. pylori in a reference~     laboratory.~   "
170376|NCT01335321|"~     The purpose of this study is to evaluate if the investigators can achieve better early~     outcomes adding triamcinolone to the viscosupplementation procedure.~   "
170377|NCT01335308|"~     BMi 2 is a study that tests a behavioral counseling approach to reduce obesity in children.~     Practitioners (Pediatricians, Nurse Practitioners) were randomly assigned to one of three~     groups. The first group continued with standard care; in group 2, each practitioner delivered~     four study Motivational Interviewing visits with the parent/caregiver, and in group 3 in~     addition to the practitioner, a registered dietitian delivered 6 Motivational Interviewing~     visits. The primary outcome will be the child's percentile BMI change between the baseline~     and 2-year follow-up. Secondary outcomes will include behavior change around fruits and~     vegetables, sweetened beverages and exercise. Our hypothesis is that there will be a larger~     decrease in BMI percentile for children in group 3 than in group 2, and that children in~     group 2 will have a decrease in BMI percentile when compared to group one.~   "
170378|NCT01335295|"~     Objective of this study is to evaluate safety and tolerability of flavocoxid administered at~     the daily oral dose of 500 or 1000 mg/die for one year in DMD patients, alone or in~     association with steroids (deflazacort on alternate days) started at least one year before.~     The investigators will also perform a multidimensional clinical evaluation covering~     functional and muscle strength and quality of life (QoL)assessments.~   "
170379|NCT01335282|"~     Traditional Chinese Medicine (TCM) has a history of more than two millenniums. It has been a~     common practice in China, Taiwan, Japan and Korea and is becoming increasingly popular~     worldwide in recent decades However, there is no general consensus for treatment of many~     diseases among TCM practitioners. In some specialties, such as neurology, there is not enough~     well documented case reports for practitioners to make reference with. Different~     practitioners may give different opinions according to their own experience and patients~     often feel frustrated about that.~      Therefore, it is worth recording cases of neurological diseases, with accurate western~     medicine diagnosis and TCM theory explained. Possible TCM treatments can be suggested~     accordingly. Being an academic research supervised by western medicine doctor, this study can~     help to suggest more objective opinion with least conflict of interest.~   "
170426|NCT01334658|"~     This is a study aimed at evaluating the effectiveness and impact of two intraocular~     irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of~     the cornea after cataract surgery by phacoemulsification.~   "
170384|NCT01335217|"~     This is a 20-subject, dose finding study to examine the use of external trigeminal nerve~     stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD)~     co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant~     medications. Our primary objective is the examination of TNS in this patient population.~      To accomplish our specific aims, the investigators will test the following specific~     hypotheses:~        1. Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the~          eight-week period.~        2. Subjects will show improvement in ratings of life functional capacity and quality of~          life with TNS.~        3. Subjects will report the TNS treatments to be acceptable in terms of side effects and~          burden of using the device.~   "
170385|NCT01335204|"~     This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with~     castration-resistant prostate cancer (CRPC). The current study is designed to determine if~     the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or~     overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine,~     and blood specimens for future research.~      This study will enroll patients with CRPC, who have been previously treated with docetaxel or~     a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or~     may have been previously treated with the agent without definite disease progression during~     therapy.~      Patients must meet the study eligibility criteria and must be competent to give informed~     consent.~   "
170386|NCT01335191|"~     This protocol represents the third in human study of TUTI-16, and is being conducted to~     gather additional safety and human immunogenicity (anti-HIV-1 Tat titers) data of~     subcutaneously administered TUTI-16.~   "
170387|NCT01335178|"~     The goal of this research project is to develop and evaluate an intervention to reduce young~     child tobacco smoke exposure~   "
170388|NCT01335165|"~     The purpose of this research study is to understand the safety, pharmacokinetics and~     pharmacodynamics of a single dose of TT30 (ALXN1102 and ALXN1103 formulations) when given IV~     (through a vein) or SC (under the skin) to patients with PNH.~   "
170389|NCT01335152|"~     Stress Management interventions have been shown to decrease cancer-related distress, foster~     emotional growth and improve immune functioning during treatment for breast cancer.~      This study will evaluate an online version of a stress management intervention for women with~     early stage breast cancer. Each chapter of the 10-week intervention include self-assessment~     and targeted feedback, education, interactive learning exercises -- all tailored to the needs~     of women with early stage breast cancer. In addition, guided writing exercises will promote~     emotional expression and a discussion board will encourage group support.~      The web-based intervention is being evaluated in a randomized clinical trial with a sample of~     120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week~     intervention with biweekly telephone assessments or to the telephone assessments alone.~   "
170390|NCT01335139|"~     The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT,~     grass pollen tablets under the tongue) has long term effects in severe hay fever.~   "
170391|NCT01335126|"~     The purpose of this study is to evaluate the performance between two emulsion-type artificial~     tears.~   "
170392|NCT01335113|"~     The purpose of the investigators study is to determine the relationship between the length of~     the eye and the rate of change in eye length at each visit with progression of retinopathy of~     prematurity.~   "
170393|NCT01335100|"~     Background:~      Motor impairment limits social and recreational activities in children with cerebral palsy~     (CP), compromising participation and impacting on quality of life. Improvement of motor~     function by medical treatment may advance in participation of outdoor activities and expand~     social and recreational activities. While Botulinum toxin (BTX) injections are effective and~     safe treatment for spasticity in children with CP, there is insufficient evidence for~     improvement of motor function and enhanced participation in this population.~      Objective:~      To examine outdoor activity as a functional outcome following lower limb BTX in children with~     CP.~      Methods:~      In this pilot study the investigators will use Global Positioning Systems (GPS) to measure~     walking speed, distances, number of walking events and destinations in ambulatory children~     with CP following BTX injection to the lower limbs; age and gender matched sibling will be~     studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following~     BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will be~     correlated with leisure activity preferences and quality of life questionnaires.~      Significance: Improvement in outdoor activity following BTX injections in this pilot study~     will assist construction of a larger study evaluating participation and quality of life in~     children with CP.~   "
170394|NCT01335087|"~     OSA may be a modifiable risk factor for cardiovascular disease due to its association with~     hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA~     is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce~     snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure~     and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine~     if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA~     admitted in a hospital for an acute coronary syndrome.~      Overall objective:~      To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical~     evolution of patients with acute coronary syndrome (ACS).~      Primary objectives:~      1. To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate~     of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial~     infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new~     hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with~     ACS and co-occurring sleep apnea.~      Secondary objectives:~        1. Determine the prevalence of OSA in patients who have suffered an episode of ACS.~        2. Other secondary objectives will include the effects of CPAP on:~             -  To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic~               stroke.~             -  Components of primary composite endpoints~             -  Re-vascularization procedures~             -  To evaluate all-cause death~             -  To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias~             -  To evaluate newly diagnosed diabetes mellitus, according to standard definitions~             -  To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS))~             -  To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D).~        3. To establish the relationship between the severity and phenotype of patients with OSA~          and clinical outcomes of ACS.~        4. To establish the relationship between CPAP compliance and CV events incidence.~        5. To identify biological risk markers that allow us to establish the most important~          mechanisms involved in cardiovascular complications in these patients.~        6. To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients~          with ACS who have obstructive sleep apnea.~   "
170395|NCT01335074|"~     Sorafenib is the standard therapy for advanced liver cancer but often shows dose-limiting~     toxicities with the need to reduce the applied dose of the compound. As this limits the~     overall response rate of the therapy, a combination with temsirolimus, an inhibitor of mTOR~     signaling, will be investigated regarding safety and tolerability in patients with advanced~     liver cancer under a reduced dose of sorafenib.~   "
170400|NCT01335009|"~     This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess~     progression free survival in subjects with metastatic melanoma.~      80+ subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one~     of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease~     progression.~      Subjects must have measurable disease by CT Scan or MRI and must have completed at least one~     prior round of chemotherapy.~      Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse~     Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical~     exams/vital signs, tolerability).~   "
170401|NCT01334996|"~     In this study, the investigators will determine the utility of Tamoxifen, a non-cytotoxic~     agent, to improve quality of life, biochemical parameters, and bone marrow involvement in~     systemic mastocytosis patients having 1) up to 20% bone marrow infiltration by mast cells~     and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard~     non-cytotoxic medications regardless of the percentage bone marrow involvement by~     mastocytosis. The dose of Tamoxifen will be 20 mg/day and the duration of treatment will be~     for one year. Patients currently taking interferon alfa, imatinib mesylate, or cladribine~     will be excluded until these medications have been stopped.~   "
170402|NCT01334983|"~     The purpose of this study is to determine whether a gentle physical conditioning program~     comprised of isotonic resistive strengthening and pedometer-directed walking can improve the~     physical functioning and fatigue of patients with late stage lung or colon cancer.~   "
170403|NCT01334957|"~     The primary objective of this study is to determine the safety of a single dose of~     intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of~     postoperative pain.~   "
170404|NCT01334944|"~     The primary objective of this study is to determine the safety of a single dose of~     intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in~     the hospital setting.~   "
170405|NCT01334931|"~     Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of~     this study is to evaluate the routine use of large field of view during image acquisition for~     coronary angiography. Patients with indication of diagnostic coronary angiography will be~     randomized for the use of either large field of view during image acquisition or medium field~     of view. Patients, physician and nurse radiation exposure will be measured by digital~     dosimeter.~   "
170406|NCT01334918|"~     The purpose of this study is to compare Multidetector Computed Tomography (MDCT) and Single~     Photon Emission Computed Tomography (SPECT) stress myocardial perfusion imaging (MPI) with~     regadenoson in order to detect the presence or absence of reversible defects.~   "
170407|NCT01334905|"~     The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the~     pharmacokinetics of YM178 in healthy adult subjects.~   "
170408|NCT01334892|"~     Immunosuppression is a key intervention in patients with solid organ transplant and is~     usually achieved by combination therapy with systemic CsA or tacrolimus with azathioprine,~     mycophenolate mofetil (MMF), or corticoids. However, the outcomes after lung transplantation~     are poor when compared with those after heart, kidney, or liver transplantation, with a~     survival rate of only 55% for recipients of lung transplants.~      Additional application of aerosolised L-CsA should suppress T-cell activation in the lung~     tissue and subsequently BOS development. The overall purpose of this phase-II/III study is to~     obtain efficacy and safety data of L-CsA in the prevention of BOS.~   "
170409|NCT01334879|"~     This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation~     retinopathy in those patients who have recalcitrant disease.~   "
170410|NCT01334866|"~     This clinical study has been developed to evaluate the clinical outcomes in patients~     undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a~     minimally invasive coronary bypass procedure that is done on a beating heart via a smaller~     chest incision, thus avoiding the invasiveness of the standard procedure.~   "
170411|NCT01334853|"~     The rationale for conducting this study is to explore potential clinical and peripheral~     biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for~     persistent asthma~   "
170412|NCT01334840|"~     Water consumption is essential to maintain hydration and good health. Sodium-bicarbonated~     mineral waters are reported to have beneficial digestive and hypocholesterolemic properties.~     The aim of this study was to investigate the effects of the consumption of a~     sodium-bicarbonated mineral water (BW) with or without a meal, compared to a low mineral~     content water as a control water (CW), on postprandial serum triacylglycerols (TAG),~     cholecystokinin (CCK), and gallbladder volume.~   "
170413|NCT01334827|"~     The purpose of the study is to compare, contrast, and characterize the range of user~     perceptions and potential acceptability of three (3) topical vaginal microbicide dosage~     forms.~   "
170414|NCT01334814|"~     The proposed study is a randomized, single blind trial of intermittent versus continuous~     stimulation among essential tremor (ET) patients with a chronic history of continuous~     stimulation.~   "
170415|NCT01334801|"~     This study is being done to determine whether or not new blood test(s) can determine the~     severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral~     regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and~     tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders under~     study. The blood tests involve analysis for von Willebrand Factor antigen and activity, von~     Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The results of the~     blood tests will be compared to the information from the clinically-indicated echocardiogram~     and one blood test compared to another.~   "
170427|NCT01334645|"~     The purpose of this study is to determine whether the combination of copeptine and troponin~     adds diagnosis information to that provided by troponin alone or the combination of troponin~     and myoglobin.~      Hypothesis : If the values of troponin and copeptin are not elevated, diagnosis of acute~     myocardial infarction can be ruled out without prolonged monitoring and serial blood~     sampling.~   "
170545|NCT01333111|"~     This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this~     trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which~     the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for~     treatment and prophylaxis of bleeding episodes in patients with haemophilia B.~   "
170416|NCT01334788|"~     Chronic sleep deprivation may constitute an important and potentially correctable behavioral~     factor in the alarming increase in obesity. There are no definitive experimental studies in~     humans showing whether sleep deprivation indeed contributes to increased energy intake and/or~     reduced energy expenditure. The investigators propose a series of novel studies to~     investigate abnormalities in energy homeostasis imparted by sleep deprivation. The~     investigators will measure food intake, energy expenditure (basal metabolic rate, thermal~     effect of food, and non-exercise activity thermogenesis), and neurohormone levels in 24~     healthy subjects with normal BMI (20-25 kg/m2). Twelve subjects (6 men and 6 women) will be~     randomized to sleep deprivation. Measurements will be compared to those obtained in 12~     subjects who are randomized to a control group, and are not sleep deprived. The investigators~     will test the following hypotheses: 1. That sleep deprivation results in positive energy~     balance (increased caloric intake and decreased energy expenditure, as reflected by decreased~     non-exercise activity thermogenesis). 2. That dysregulation of appetite and energy~     expenditure is associated with changes in molecules controlling appetite and metabolism. 3.~     That changes associated with 8 days of modest sleep deprivation resolve, at least in part,~     over a 4 day recovery period.~   "
170417|NCT01334775|"~     Inguinal hernia repair coincides with a high rate of postoperative pain, extending to over a~     year in 10-20% of patients. Although this is of major concern, early postoperative pain also~     has an important impact on patients and their ability to regain normal work and activities.~     Since inguinal hernia repair is the most frequently performed operation worldwide, a small~     reduction in loss of workdays can already have significant impact on financial issues. As for~     the origin of the pain, it might be the result of local inflammation caused by the mesh~     material, but also by nerve entrapment due to fixation techniques. The development of a new~     mesh which enables sutureless fixation, Cousin Biotech® Adhesix™, may overcome pain related~     to fixation techniques used in the open hernia repair procedure according to Lichtenstein.~     Furthermore, the Cousin Biotech® Adhesix™ mesh has already been in use in our institutions~     and surgeons familiarized themselves with the application.~      The investigators would like to conduct a multicentre randomised controlled clinical trial to~     compare the difference in early postoperative pain after unilateral primary inguinal hernia~     repair in males. The procedures will be performed in day surgery. Early postoperative pain is~     defined as the pain during the first month, with a special interest in the first two weeks.~     In addition, the investigators want to measure the possible benefit in terms of time to~     return to work, daily activities, quality of life, operation length, complications and long~     term postoperative pain.~   "
170418|NCT01334762|"~     To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with~     recently surgically treated minimal to mild endometriosis.~   "
170419|NCT01334749|"~     The primary aim of the DEDEMAS (Determinants of Dementia After Stroke) study is to identify~     predictors of post stroke dementia (PSD). A particular focus will be on biological markers~     (neuroimaging, biochemical markers derived from blood) and on interactions between vascular~     and neurodegenerative mechanisms. For this purpose patients with an acute stroke and without~     prior dementia will be followed for 60 months.~      Note: Starting from 01.01.2014 this study is expanded to a multi-centric design funded by the~     German Center for Neurodegenerative Diseases (The DZNE - Mechanisms of Dementia After Stroke~     (DEMDAS) Study). This includes the following study sites: DZNE/München - Institute for Stroke~     and Dementia Research, Klinikum der Universität München (Coordinator); DZNE/Berlin -~     Neuroscience Research Center - Campus Mitte Charité; DZNE/Bonn - Klinik und Poliklinik für~     Neurologie, Universitätsklinikum Bonn; DZNE/Göttingen - University Medical Center Göttingen;~     DZNE/Magdeburg - Universitätsklinikum Magdeburg.~   "
170420|NCT01334736|"~     Cigarette smoking is very common in current and former injection drug users and is known to~     cause chronic lung diseases. Quitting smoking is proven to improve the health of people~     addicted to cigarettes. . Little information exists regarding the perceptions and~     characteristics of drug users regarding quitting smoking. Additionally, most programs~     designed to help people quit smoking are not very successful. One reason these programs may~     not work well is because it is difficult to motivate people to quit smoking. New methods of~     motivating changes in behavior include small monetary payments for healthy behavior and~     reporting breathing tests with the concept of lung age, which is the age of an average~     healthy person with similar breathing test results. For example, a health care provider can~     report results as Although you are 50 years old, you have the lungs for a 70 year old. In~     this proposal, the investigators plan to first explore the beliefs and characteristics of~     current and former injection drug users and how they are related to quitting smoking. The~     investigators then plan to study whether the use of two new methods of motivation increases~     the chances that this group will stop smoking.~   "
170421|NCT01334723|"~     This retrospective study aims to quantify the relationship between 5-alpha-reductase~     inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention~     (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the~     economic impact associated with these medical encounters. The Integrated Health Care~     Information Solutions (IHCIS) database will be utilized for this study (2000-2006).~   "
170422|NCT01334710|"~     The purpose of this study is to evaluate the effect of combining a new investigational drug~     (OSI-906) with a standard drug (sorafenib) on the control of liver cancer (hepatocellular~     cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of~     advanced liver cancer. It works by stopping the growth of new blood vessels around the tumor.~     OSI-906 is an investigational agent that works by inhibiting the effects of a growth hormone~     on the cancer. The safety and efficacy of combining OSI-906 and sorafenib in the treatment of~     liver cancer risk not known. The current study will confirm the safety of the combination in~     the first six patients and evaluate the activity of the combination in patients with advanced~     liver cancer.~      In addition, the study will aim at collecting blood samples from patients to evaluate the~     level of OSI-906 in patients receiving the combination of the two drugs. The study also will~     collect samples of the tumor to evaluate for markers that can predict in which patient the~     combination is effective.~   "
170423|NCT01334697|"~     The general aim of the study is to determinate safety, tolerability and early~     pharmacokinetics of cardiotrophin.1 in healthy volunteers.~   "
170458|NCT01334242|"~     The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to~     meals in healthy subjects.~   "
170428|NCT01334632|"~     Brachial plexus injury after shoulder surgery with continuous interscalene block is 2.4% at 1~     month and 0% at 6 months, but may be higher with a systematic postoperative neurological~     examination. Indeed, femoral neuropathy after anterior cruciate ligament reconstruction is~     24% at 6 weeks in a cohort of 20 consecutive patients systematically screened with an~     electromyogram. Brachial plexus injury may be the consequence of the surgery (direct lesion~     by traction) or the continuous interscalene block. The goal of this study is to define the~     etiology of this postoperative neuropathy.~   "
170429|NCT01334619|"~     The retrograde infraclavicular brachial plexus block has been proved an effective and safe~     approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The~     purpose of this study was to determine the medium effective volume required to produce an~     effective retrograde infraclavicular block using an ultrasound (US)-guided technique.~   "
170430|NCT01334606|"~     The primary purpose of this study is to demonstrate that the BD 4mm x 32G Ultra-Fine Nano pen~     needle provides equivalent glycemic control to the BD 8mm x 31G Ultra-Fine short pen needle~     as measured by fructosamine (FRU) among Lantus®, Levemir®, and/or NPH users taking one or~     more single daily injections of greater than 40 units of insulin.~      Glycemic control, injection pain, leakage, preference, comfort, and other parameters will be~     compared between the 4mm x 32G and the 8 mm x 31 G pen needle after three weeks of use of~     each device. Sufficient numbers of subjects taking Lantus® as their basal insulin will be~     enrolled so as to allow for pre-specified analysis of this subgroup.~   "
170431|NCT01334593|"~     Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and~     rectal) cancer is associated with improved survival, but also adversely affects physical~     fitness, potentially rendering patients unfit for major surgery or increasing the risk of~     adverse outcome (death and serious complications) after major surgery. The investigators aim~     to obtain pilot data showing that neoadjuvant chemoradiotherapy (NACRT)reduces objectively~     measured exercise capacity (fitness).~   "
170432|NCT01334580|"~     This study involves the comparison of two treatment approaches for patients with chronic pain~     who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an~     integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a~     counseling intervention that addresses opioid dependence only.~   "
170433|NCT01334567|"~     The purpose of this study is to offer subjects from centers in Taiwan who successfully~     complete 168 weeks of treatment in study GS US 174-0108 access to treatment with tenofovir DF~     for up to three additional years (144 weeks). Subjects will be followed per local standard of~     care. Serious adverse events (SAEs), drug accountability and patient disposition will be~     recorded.~   "
170434|NCT01334554|"~     Obesity has a greater detrimental impact on the health of African American women than on any~     other racial or gender group. Nearly 80% of African American women are overweight or obese in~     the United States. Hypertension and insulin resistance are more prevalent among African~     American women as compared to men and Caucasians. These conditions put them at increased risk~     for the development of diabetes mellitus and cardiovascular disease.~      Recent studies have reported that a substance named Nitric Oxide (NO)may have some beneficial~     effect on how the body handles blood sugar and blood pressure. Of interest,some studies have~     shown that African Americans have decreased function of NO in their blood vessels.~      In this study proposal the investigators will test if increasing NO function with a PDE-5~     inhibitor (sildenafil citrate) will improve pre-diabetes and the health of the inner layer of~     the blood vessels in obese African American women.~   "
170435|NCT01334541|"~     The investigators propose to evaluate Suicide Assessment and Follow-up Engagement: Veteran~     Emergency Treatment (SAFE VET) which is currently being implemented in 4 VA ED/Urgent Care~     Units across the United States (Portland VA Medical Center (VAMC), Denver VAMC, Manhattan~     VAMC, and Philadelphia VAMC).~   "
170436|NCT01334528|"~     The purpose of this project is to explore the degree to which performance consistency on~     neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation~     Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with~     persistent self-reported symptoms.~   "
170437|NCT01334515|"~     This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works~     when given together with sargramostim and isotretinoin in treating patients with relapsed or~     refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and~     sargramostim work in different ways to stimulate the immune system and stop tumor cells from~     growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor~     cells.~   "
170438|NCT01334502|"~     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer cells in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and~     prednisone, work in different ways to stop the growth of cancer cells, either by killing the~     cells or stopping them from dividing. Giving everolimus together with rituximab,~     cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone may kill~     more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and the best dose of everolimus when~     given together with rituximab and combination chemotherapy in treating patients with newly~     diagnosed untreated diffuse large B-cell lymphoma.~   "
170439|NCT01334489|"~     Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated~     by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate.~   "
170440|NCT01334476|"~     The VISN 19 MIRECC is involved in research concerned with suicide prevention in high risk~     populations (e.g., history of traumatic brain injury, post-traumatic stress disorder);~     Recruitment for future studies will continue with a similar focus. The aim of this protocol~     is for the VISN 19 MIRECC Research Database (V19-MRD), to have a data repository of~     participants for possible recruitment from other studies being conducted at the VISN 19~     MIRECC. The VISN 19 MIRECC conducts numerous research projects under the review of COMIRB and~     the VA R&D.~   "
170441|NCT01334463|"~     1. To determine whether tasks taken from the field of cognitive neuroscience can detect and~          distinguish impairments in executive function above and beyond standard~          neuropsychological measures in individuals with: a.) Mild Traumatic Brain Injury (TBI),~          b.) Post Traumatic Stress Disorder (PTSD), c.)Mild TBI+PTSD~        2. To determine whether performance on these tasks is linked to pertinent psychiatric~          outcomes (e.g. history of suicidality), which is associated with compromised executive~          function and impulsivity.~        3. To determine whether information regarding brain anatomy can provide additional~          information above and beyond behavior performance in distinguishing between these two~          groups.~   "
170442|NCT01334450|"~     Transcranial Magnetic Stimulation (TMS) for treatment of Alzheimer disease.~   "
170443|NCT01334437|"~     Intend of use: A blood test for Cancer Associated Antibodies (CAAA) is an aid in initial~     diagnosis of ovarian cancer in women with suspected ovarian pathology as detected by primary~     diagnostic techniques.~      Test Description: Blood is collected from patients and serum/plasma is tested for the~     presence of CAAA on experimental test kit.~      Objectives: To assess the effectiveness of the CAAA test.~      Target Population:~      The study population will include women that have been diagnosed with suspected ovarian~     cancer (OC), verified by pathology/cytology as patients, women with suspected ovarian cancer~     but verified by pathology/cytology as non-cancers and a control set of blood samples will be~     collected from age matched women with no history of cancer.~      Structure: Women that will be enrolled for the study will be checked for the presence of~     CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the~     physicians in the participating centers for the patient population and to the clinical~     history for the control population.~      Sample Size: The investigators will collect at least 50 patients verified by~     pathology/cytology and for each patient at least two aged matched healthy controls and two~     aged matched suspected but verified as non-cancers. Total amount at least 250 samples.~      (Multi center study, statistical rationale provided below).~      Primary Effectiveness Variables: The effectiveness of the test will be defined by the~     specificity of the test conditionally that the sensitivity is not lower than a pre-defined~     level of 95%.~      Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%.~      Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical~     trials. All data will be stored in a protected internet-based database, and any changes of~     the data will be traced and recorded.~   "
170444|NCT01334424|"~     Gut hypoperfusion - reperfusion injury is an unavoidable event at the end of laparoscopic~     surgery. It produces oxidative stress (reactive oxygen species). Malondialdehyde have been~     demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.~     Propofol (2, 6 - diisopropylphenol), a highly liposoluble anaesthetic, has a potent~     antioxidant activity against lipid peroxidation in both in vitron and in vivo studies. On the~     basis of this knowledge, the investigators hypothesized that propofol has preventive effect~     for gut hypoperfusion - reperfusion induced injury in robot-assisted laparoscopic radical~     prostatectomy.~   "
170445|NCT01334411|"~     Aim: To identify examples of surgeons good and poor intraoperative behaviours related to safe~     and efficient surgery.~      Methods: Ten observations will undertaken in the operating theatres of Rigshospitalet and~     Herlev Hospital with the researchers taking field notes. This provides the Ph.d student with~     empirical background knowledge of observed surgical behaviour as well as an understanding of~     surgical culture. The knowledge will be used to qualify the interviewguide.~      8 semi-structured group interviews and 3 individual interviews will be conducted and tape~     recorded. The interviews will be led by the Ph.d student with an anesthesia nurse present as~     a co-moderator. The groups will contain 4 - 12 participants.~      The interview guide will be developed with a Scottish behavioural marker system as a~     framework, drawing upon the literature as well as the observations. It will contain questions~     regarding leadership, communication, teamwork, situation awareness and decision making to~     facilitate a discussion about surgeons' good and poor behaviours.~      Material: Data will be collected in two hospitals in the capital Region of Denmark,~     Rigshospitalet and Herlev Hospital. Each hospital will provide four focus groups, one~     containing consultant surgeons in general surgery, one trainee surgeons, one scrub nurses and~     one containing a mixture of anesthetists and anesthesia nurses. The two latter focus groups~     is included to get the perspectives of the surgeons' team members since international studies~     have demonstrated differences of opinion regarding the perceived quality of teamwork amongst~     operating theatre staff. This study will be the first to build in the opinions of the team~     members into a behavioural marker system. 3 individual interviews with surgeons will~     afterwards conducted in one of the hospitals to get a more in-depth discussion.~      Data analysis and statistics: The interviews will be fully transcribed and analysed using~     qualitative method of systematic text condensation. Power calculations are not relevant in~     this qualitative study. Accepted guidelines state that the number of participants in each~     group should range between 5 and 15 and the data are from two large university hospitals~     receiving different patient categories to ensure a certain representative sample of~     informants.~   "
170446|NCT01334398|"~     The primary goal of the proposed study is to evaluate the efficacy of a replicable~     community-based group intervention, designed to address both general wellness and specific~     TBI health-related issues. Emphasis is placed on goal setting to develop healthy habits,~     utilizing problem solving strategies, learning means of maintaining progress and setting new~     goals. Facilitators will utilize approaches aimed at maximizing participant self-efficacy,~     reducing barriers to health promotion, and developing personal resources. A randomized~     wait-list control group design will be used to evaluate the efficacy of the intervention. It~     is hypothesized that individuals with TBI who participate in the intervention group will~     report increased health promoting behaviors, health related self-efficacy, health-related~     quality of life, level of participation, and greater perceived wellness and satisfaction with~     life as compared to the control group.~   "
170447|NCT01334385|"~     Veterans possess significant risk factors for self-directed violence (SDV). For example,~     depressed Veterans are at a greater risk for SDV than the general population. Although~     depressed male Veterans die by suicide at a higher rate than do their female counterparts~     (Zivin et al., 2007), female Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)~     Veterans are at higher risk for depression than males (Seal et al., 2009). Joiner's (2005)~     theory states that suicidal individuals (a) perceive themselves to be unbearable burdens onto~     others; (b) view their efforts at establishing and maintaining social connections as having~     been thwarted or failed; and (c) have developed the ability to engage in SDV due to from~     increased habituation to pain. This two-part study uses semi-structured interviews in an~     effort to determine the extent to which Joiner's theory is applicable to OEF/OIF Veterans.~     Part I of this study, which has been completed, assessed the components of this theory among~     primarily male OEF/OIF Veterans. Part II of this study is assessing this theory's components~     among female OEF/OIF Veterans. Participants were recruited from the female OEF/OIF Veteran~     population receiving services through the Eastern Colorado Health Care System (ECHCS).~     Comparisons across the interview responses will be made to identify commonalities among the~     participants' experiences.~   "
170448|NCT01334372|"~     This investigation is a feasibility study conducted in a VA outpatient treatment setting. The~     study is designed to test the feasibility of implementing a novel way of working with~     suicidal patients, the Collaborative Assessment and Management of Suicidality (CAMS). The~     primary purpose of the proposed project is to determine if it is possible to train clinicians~     working in the Mental Health Clinic at the Denver VA Medical Center (VAMC) to utilize this~     therapeutic framework. This project is extremely timely in relation to expectations of future~     increased clinical demands among potentially high-risk Operation Enduring Freedom/Operation~     Iraqi Freedom (OEF/OIF) veterans who may become suicidal in the years to come.~   "
170449|NCT01334359|"~     Recent trends have identified decreasing levels of physical activity, fitness, and health in~     preadolescent children. Examining factors, such as physical activity behavior and aerobic~     fitness that positively influence cognitive health of school-age children are important for~     improving school performance, maximizing health, and improving the overall functioning of~     individuals as they progress through the human lifespan. A sample of preadolescent children~     from the Urbana, Illinois elementary school system will be randomly assigned to a 9- month~     afterschool program that focuses on either aerobic exercise or wait-list control group to~     determine the effects of physical activity on basic and applied aspects of cognition. Changes~     in neuroimaging and behavioral indices of cognitive function and performance on standardized~     academic achievement tests of mathematics and reading will be examined as a function of~     participation in the intervention. Preliminary research supports that physical activity is~     positively associated with basic and applied aspects of cognition, with a stronger~     relationship for tasks requiring extensive amounts of executive control. However, previous~     research has mainly focused on older adults, and little research has examined the~     relationship between physical activity and executive control in children. These findings will~     provide lifestyle considerations for children to improve their cognitive health across the~     lifespan.~   "
170450|NCT01334346|"~     The following study proposes to investigate the injury risk associated with the use of a new~     category of running footwear: the minimalist shoe. A group of experienced adult male and~     female runners with neutral foot types will take part in this study. All participants will be~     randomized to receive one of three different shoes: a full minimalist shoe (Vibram~     5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive~     running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes~     to be investigated are pain, footwear perception, and number of injury events.~      The hypothesizes is that participants using the minimalist footwear during their running~     program will experience a reduction in running related pain. A greater degree of footwear~     minimalism will result in a greater reduction in pain (compared to the partial minimalist~     shoe, Nike Free).~   "
170451|NCT01334333|"~     A critical aspect of real-world functioning following kidney transplantation involves how~     adherent individuals are to their medication regimens. Regardless of the possible dangers of~     failing to adhere to anti-rejection medications, such as increased graft rejection, studies~     have reported rates of non-adherence at almost 50% following renal transplant.~      The Cognitive Aging Laboratory under the direction of Dr. Wendy Thornton, at Simon Fraser~     University, has previously identified relationships between several potentially important~     cognitive and psychosocial variables, and self-reported medication adherence in renal~     transplant recipients, including depressive symptoms, as well as everyday and traditional~     cognitive functioning [4]. The possibility that changes in dosing regimens for a given~     medication may have an additional impact on medication adherence presents an important issue~     worth further exploration.~      The current study will allow for more thorough delineation of the roles of psychosocial and~     cognitive predictors of adherence with state-of-the-art monitoring techniques. In addition,~     the investigators will assess whether different dosing formulations of tacrolimus impact~     adherence behaviors in renal transplant recipients.~      The proposed research has two primary aims to examine:~        1. To examine the role of cognitive and psychosocial variables in predicting medication~          adherence in renal transplant recipients.~        2. To examine whether different formulations of tacrolimus (once per day dosing versus~          twice per day dosing) will impact medication adherence in renal transplant recipients.~   "
170452|NCT01334320|"~     Controversy over surgical treatment of clinically negative neck in early stage oral squamous~     cell carcinoma revolves around the uncertainty of its impact on patient prognosis. The~     efficacy of elective neck dissection on prognosis in T1, 2 N0M0 patients continues to be the~     subject of clinical debate. Currently the clinically negative patients are treated by one of~     the two main policies: one is elective neck dissection; the other is watchful waiting. The~     objective of this multi-institutional prospective randomized controlled study is to evaluate~     the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with~     carcinoma of oral cavity. The enrolled patients with T1, 2 N0M0 oral cancer will be~     randomized into two groups: elective neck dissection versus watch and wait. The survival rate~     and the recurrence rate between two groups will be compared. The result of the study will~     give surgeons evidence-based instructions for the management of clinically negative neck in~     patients with cancer of oral cavity.~   "
170453|NCT01334307|"~     The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc.~     Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx,~     Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.~   "
170454|NCT01334294|"~     ForeseeHome, an FDA-approved home device, was specifically designed for unsupervised~     Preferential-Hyperacuity-Perimeter (PHP) testing of Age Related Macular Degeneration (AMD)~     patients at home by characterizing central and paracentral metamorphopsia . The purpose of~     the current study is to evaluate if, in post-treatment patients, PHP parameters as measured~     with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as~     measured with optical coherence tomography (OCT).~   "
170455|NCT01334281|"~     This study is being done because the study doctor is trying to develop a new test which will~     help transplant doctors monitor patients with high panel reactive antibodies (PRA). The test~     would be used to monitor patients' PRA when doctors are trying to lower it through a process~     known as desensitization. Desensitization lowers high PRA levels and allows patients to~     receive transplants. This is a single center study to evaluate and optimize the use of a new~     laboratory test to detect and measure the immune system's functioning.~   "
170456|NCT01334268|"~     The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9~     months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and~     the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System~     compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer~     patient population requiring stent implantation.~   "
170457|NCT01334255|"~     LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of~     iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of~     Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related~     Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV).~   "
170459|NCT01334229|"~     Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), and has~     been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes~     mainly through incretin hormone-mediated improvements in islet function [13]. Although~     clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-IV~     inhibitor treatment [14-16], animal studies suggested that DPP-IV inhibition reduce~     intestinal triglycerides (TG) absorption and apolipoprotein (apo) production [17] and~     increased chylomicron catabolism [18]. Interestingly, a recent study supporting this~     hypothesis showed that vildagliptin therapy was able to reduce postprandial intestinal~     triglyceride-rich lipoproteins (TRL) particles in patients with type 2 diabetes [19].~     Recently, our group has reported that sitagliptin treatment significantly reduced plasma apo~     B-48 and TG concentrations in the postprandial state. Moreover, animal studies showed that~     sitagliptin decreased intestinal secretion of intestinal apo B-48, mainly by increasing level~     of glucagon-like peptide (GLP)-1 [20]. Therefore, the present study was designed to examine~     the effects of sitagliptin on the kinetics of TRL apo B-48 and in patients with type 2~     diabetes. A possible reduction in postprandial atherogenic TRL apo B-48-containing~     lipoprotein levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor~     and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.~   "
170460|NCT01334216|"~     The CHICA system is a clinical decision support system that uses adaptive turnaround~     documents to provide point-of-care information to clinicians. The investigators will be~     studying whether it can help to support parents in their efforts to quit smoking.~   "
170461|NCT01334203|"~     This study will evaluate the efficacy of ranolazine compared to placebo on duration of~     exercise assessed by exercise tolerance testing (ETT) at anticipated peak ranolazine plasma~     concentration after 12 weeks of treatment in subjects with chronic stable angina and coronary~     artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM).~   "
170462|NCT01334190|"~     This will be a non-comparative prospective observational study of women using Zarin as a~     primary method of contraception in Kenya. It will be conducted in close collaboration with~     the Kenya MoH in several MoH-affiliated clinics that have experience with implants and~     sufficient expected flow of implant users per month. The investigators will enroll a total of~     600 women divided into two cohorts in this one-year prospective study:~        -  a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months~          after enrollment; and~        -  a surveillance cohort of 300 women who will report back to the clinic during 12 months~          after enrollment only if they have complications, medical problems, pregnancy, or want~          to remove the implant~      The main study outcomes are pregnancy, immediate and delayed complications associated with~     insertion or removal, adverse events, early discontinuation and reasons for discontinuation,~     and level of women's satisfaction with Zarin services.~   "
170463|NCT01334177|"~     This phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 when given~     together with cetuximab in treating patients with locally advanced, recurrent, or metastatic~     squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as TLR8 Agonist~     VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing.~     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving TLR8 Agonist VTX-2337 together with~     cetuximab may kill more tumor cells.~   "
170464|NCT01334164|"~     The proposed study is designed to test the effectiveness of recovery management checkups for~     women offenders (RMC-WO) released from jail to provide continuity of care immediately upon~     release and to help them manage their long-term recovery. The hypotheses in the first phase~     were: 1)women assigned to RMC (versus control) will a) return to treatment sooner after the~     initial release from jail and b) be more likely to receive treatment in the 90 days after~     release from jail; 2)women who received treatment in the first 90 days post release (vs. no~     treatment) will be more likely to sustain their abstinence through 90 days post release from~     a) any alcohol or drugs, b) alcohol, c) cannabis, d) cocaine, and e) opiates; 3)women who~     maintained their abstinence from any alcohol and other drugs through the first 90 days post~     release (vs. any relapse) will be less likely to have a) unprotected sex, b) commit any other~     illegal activity, and d) be re-incarcerated in jail or prison. In the second phase repeated~     exposure to these efforts on a quarterly basis is expected to further strengthen each of~     these effects.~   "
170465|NCT01334151|"~     The primary objective of this study is to assess the speed of absorption and onset of action~     of BIOD-105 and BIOD-107 and compare them to Humalog®.~   "
170466|NCT01334138|"~     There is strong evidence that our current consumption of salt is the major factor increasing~     blood pressure (BP). The current salt intake in most countries in the world is 9 to 12 grams~     per day (g/d), whil the World Health Organization's recommendation is < 5 g/d.~      The aims of the present study is to determine if the overconsumption of salt influences the~     bp in patients with uncontrolled hypertension or frequently elevated bp.~      Each study subject will complete questionnaires, and their usual dietary salt intake is~     estimated from food composition on 3 completed food diaries. This is also compared with a~     24-hour urine sample collection.~      Based on these results, the study subject receives personal advice to decrease sodium~     consumption and will change the diet for at least 28 days. During this diet, bp will be~     measured and food diaries will be completed. After the intervention, a questionnaire and a~     24-hour urine sample collection will be collected.~   "
170467|NCT01334125|"~     The significance of this project is to investigate the effects of adjunctive metformin~     therapy in children and adolescents with double diabetes. Double diabetes describes a~     clinical state where an individual possesses features of both type 1 and type 2 diabetes.~     There is a paucity of data on the role of adjunctive metformin therapy in children and~     adolescents with double diabetes. To help fill this knowledge gap, the investigators propose~     a randomized, double-blind, placebo-controlled trial of metformin in double diabetes.~     Specifically, the investigators will evaluate changes in hemoglobin A1c and anthropometry in~     patients with a diagnosis of type 1 diabetes who also have features of type 2 diabetes or~     metabolic syndrome as well as patients with type 2 diabetes who possess diabetes-associated~     autoantibodies. This will help determine the safety profile, and efficacy of adjunctive~     metformin therapy in these subjects.~   "
170470|NCT01334086|"~     Chemotherapy induced nausea and vomiting (CINV) is a major adverse effect of chemotherapy.~     This study is determining the incidence of vomiting/retching of the standard induction~     chemotherapy regimen for patients with acute myeloid leukemia (AML) who are also receiving an~     antiemetic known as aprepitant.~      The standard frontline chemotherapy for patients with AML consists of cytarabine given as a 7~     day continuous infusion plus 3 days of an anthracycline, most commonly daunorubicin, on days~     1-3. This is known as the 3+7 regimen. Antiemetic treatments are usually given to patients~     for nausea and vomiting. Granisetron (a 5-HT3 receptor antagonist) is used on the 3~     daunorubicin days and other antiemetics can be used for breakthrough nausea/vomiting.~      This study will test that the prophylactic use of aprepitant, in addition to the standard~     antiemetic regimen used at Princess Margaret Hospital (PMH), will reduce the incidence of~     delayed onset vomiting/retching by Day 5 in AML patients receiving the standard 3+7 regimen,~     compared to retrospective data using this regimen.~   "
170471|NCT01334073|"~     The aim of the study is to determine the MTD of the combination of everolimus plus axitinib~     in solid tumors, especially RCC.~   "
170472|NCT01334060|"~     The study is not currently recruiting new subjects due to an interruption in funding from its~     sponsors. Efforts are under way to re-establish funding, however, the study is currently~     on-hold pending the outcome of these re-funding efforts. There have been no safety concerns~     identified during the study~      This is an open label, single dose level, phase II study in two patient groups (CML and AML)~     using genetic randomisation. Consented and eligible HLA A2+ve patients will be vaccinated~     with two DNA vaccines and HLA A2 -ve patients will be followed up with molecular monitoring~     only. The objectives are to evaluate: 1) Molecular response following p.DOM-epitope DNA~     vaccination in patients with CML (BCR-ABL, WT1) and AML (WT1) at weeks 4, 8, 12, 16, 20 and~     at months 6, 12, 18 and 24. 2) Time to disease progression, 2 year survival rate (patients~     with AML) 3) Correlation of molecular responses with immunological responses. Primary~     Objective: CML: Molecular response of BCR-ABL. AML: Time to disease progression. Secondary~     Objective: Molecular response of WT1 transcript levels, immune responses to WT1 and DOM,~     Toxicity, CML-Time to disease progression, next treatment and survival, AML-2 year survival,~     overall survival~   "
170473|NCT01334047|"~     In this study the investigators will include patients with relapsed epithelial ovarian~     cancer. In spite of increased rates of complete response to initial chemotherapy, most~     patients with advanced ovarian cancer relapse and succumb to progressive disease.~     Immunotherapy may have potential for consolidation therapy. Dendritic cell vaccine is well~     toleranted in previous studies, with minor side effects and no serious adverse events~     registrated In this study, patients will receive DC-vaccine therapy after response to~     platinum treatment at relapse. The investigtors include patients in good clinical condition~     with no severe symptoms of the disease. If patients relapse during vaccine treatment, they~     will be discontinued from the study.~      The investigators have included hTERT- and survivin mRNA in addition to amplified cancer stem~     cell mRNA in the vaccine.~   "
170474|NCT01334034|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the~     pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as~     tablets in healthy subjects.~   "
170475|NCT01334021|"~     The goal of this research study is find out if researchers can use genetic testing on tumor~     samples to predict if tumors will respond to breast cancer treatments. The tumor sample will~     be tested to learn if certain genes are activated (turned on) in the tumor. Researchers hope~     that the activation of these genes may predict if the tumor will be sensitive or resistant to~     routine breast cancer treatments, such as chemotherapy or hormonal therapy.~      This is an investigational study. The test that will be performed on your breast cancer tumor~     sample is an investigational test.~      Up to 1100 patients will take part in this study. All will be enrolled at MD Anderson.~   "
170476|NCT01334008|"~     Circulating tumor DNA detection and quantification in patients with metastatic choroidal~     melanoma.~   "
170477|NCT01333995|"~     Child undernutrition remains a highly prevalent condition in low and middle income countries~     and a major portion of the global burden of childhood malnutrition is found in South Asia~     with an estimated 74 million children living with chronic malnutrition (stunted growth) in~     this region. This burden of malnutrition accounts for approximately 50% of under five child~     deaths in developing countries. The risk of child death is also related to the severity of~     malnutrition and progressively increases the more the child's growth deviates from WHO Growth~     Standard, e.g. children with height-for-age <-3 Z scores from the standard have a four fold~     increased mortality risk compared to children within one Z score of the growth standard mean.~     Underweight in children for 18.7% of the global disability-adjusted life years in children~     less than five years of age. Childhood malnutrition is a pervasive problem in Bangladesh with~     43% of children less than five years stunted in 2004 and 38% in urban child populations. An~     establish approach to promoting appropriate breastfeeding practices is through the use of~     local peer counsellors to provide information and to support to mothers. A recent study has~     conducted on pioneering research on this approach in Bangladesh.. The main aim of the study~     is to use a Cluster Randomized Control Trial (CRCT) to collect high-level evidence of whether~     peer counselling of women to promote appropriate breastfeeding and complementary feeding can~     improve feeding practices, child growth and reduce the prevalence of malnutrition in their~     children.~      The investigators will use a community-based Cluster Randomized Control Trial (CRCT) to~     examine the impact of a peer counselling infant feeding education program starting in the~     third trimester of pregnancy to one year after delivery, to improve child feeding practices,~     child growth and reduce the prevalence of malnutrition in their children. This will result in~     two study groups. The outcome assessments will be made on a cohort of infant-mother dyads~     measured at baseline and at follow up visits because the investigators expect a likely high~     correlation between baseline and follow up outcome measures, thus making this approach the~     most efficient study design. Outcome assessments will be conducted with all the mother-infant~     pairs recruited in the community clusters in the study, with an expected total of 1950~     mother-infant days (975 in each treatment group). The peer counseling education will be~     offered to eligible pregnant women identified by household surveys over 3 months in each~     community cluster in the intervention group. Using a similar approach to recruitment, a~     cohort of mother-infant dyads, who will receive standard maternal and child health care~     programs, will be identified in the control clusters.~      Data will be collected on anthropometry, feeding practices and hygiene and caring practices~     etc. The investigators will report the results for 2-sided 5% tests for the primary trial~     outcome. Secondary analyses will examine each outcome variable (stunting, height-for-age,~     feeding patterns, and mean nutrient intakes) taking account of the repeated measurements~     within children by using separate mixed models. The investigators will use linear mixed~     models for continuous outcomes (e.g. height-for-age Z) and generalized linear mixed models~     for non-continuous outcomes (e.g. logistic mixed models for binary outcomes e.g. percentage~     exclusively breastfeeding). It is expected that the publications from this research will have~     substantial impact on child health and will help with the development of public health~     nutrition policies for children in South Asia and will be widely cited.~   "
170478|NCT01333982|"~     More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal~     period), and a substantial proportion of these deaths are due to infections (sepsis).~     According to the recently formulated Bangladesh National Neonatal Health Strategy (NNHS), the~     Government of Bangladesh is committed to improve access to quality management of neonatal~     infections. The strategy emphasizes that health service providers at all levels acquire the~     skills for managing sepsis.~      Responding to the recommendations in the National Neonatal Health Strategy, this operations~     research seeks to evaluate alternative approaches for the management of neonatal sepsis in~     the community. The evaluation will focus on assessing intervention coverage, provider quality~     of care, and referral and referral compliance, and will undertake cost-benefit analysis of~     community-based neonatal sepsis management. The programme and evaluation will be within the~     existing health service delivery system in Bangladesh and is thus designed to inform the~     effective scaling up of neonatal sepsis management and contribute to the implementation of~     the NNHS. The interventions to be evaluated will be nested in the Maternal, Neonatal and~     Child Survival (MNCS) programme being implemented by the Government of Bangladesh, in~     partnership with and supported by UNICEF, and several national NGOs.~      This operations research is being implemented by the Government of Bangladesh in~     collaboration with UNICEF, SNL - Save the Children (USA), Bangladesh Perinatal Society, and~     ICDDR,B. It will take place in four MNCS programme upazilas, where 10 unions will be randomly~     selected for intervention and 10 unions will be comparison. The intervention consists of~     training of community health workers, village doctors and health facility workers on managing~     neonatal sepsis in addition to essential newborn care training. In the comparison areas the~     health workers will only receive essential newborn care training.~      The intervention and evaluation will continue for at least 18 months, with rolling surveys~     and two special surveys at 6 and 12 months into the project. The rolling surveys will look at~     intervention coverage, care-seeking, and referral and referral compliance, while the two~     special surveys will assess provider performance, referral compliance, and quality of care.~     In addition, the investigators will document implementation processes to understand what~     worked and what did not and why.~   "
170479|NCT01333969|"~     The application of a tourniquet for 5 minutes and subsequent reperfusion before actual~     inflation of the tourniquet for total knee arthroplasty (ischemic preconditioning) decreases~     the level of local inflammation and therefore postoperative pain in response to reperfusion~     of the ischemic extremity.~   "
170480|NCT01333956|"~     Total knee arthroplasty can cause severe postoperative pain, and patients typically receive~     oral opioid analgesics for over 2 weeks. Side effects of pain management may impair~     participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems~     that pregabalin is very helpful to patients after total knee arthroplasty. However,~     pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses~     may not be effective, but use of high doses may increase the incidence and severity of side~     effects.The purpose of this study is to determine which dosage of pregabalin is the most~     effective at reducing pain after knee surgery.~   "
170568|NCT01332812|"~     This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive~     dysfunction in the postoperative period of elderly patients undergoing to surgery under~     general anesthesia.~   "
170481|NCT01333943|"~     Currently, the regional anesthetic standard of care for total knee replacement surgery is~     combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting~     approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which~     is the major nerve controlling the knee joint. The femoral nerve also provides movement and~     sensation. While this regional anesthetic technique offers significant postoperative pain~     relief, it is possible that it may cause muscle weakness and increase patients' recovery~     time. Hence there is a need for an alternative technique, one that may help minimize~     postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps~     muscle.~      The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it~     is hypothesized that by blocking or anesthetizing the saphenous nerve with local anesthetic~     closer to where it branches off, the area around and below the knee will feel numb. Yet~     unlike with the FNB, the quadriceps muscle itself will still be able to function.~      Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will~     be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia~     administration, and on postoperative days 1 and 2. It is hypothesized that patients who~     receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.~   "
170482|NCT01333930|"~     The aims of this study are:~        -  Characterisation of immunological effects of Active O2 vs. placebo after ingestion~          during and post standardised strenuous exercise~        -  Characterisation of safety and tolerability of Active O2 in comparison with placebo~          after ingestion during and post standardised strenuous exercise considering Adverse~          Events observed in the study~      Moreover, the suitability of the study design shall be investigated by means of the internal~     pilot part, i.e. concerning applied procedures, selected pharmacodynamic parameters and blood~     sampling scheme.~   "
170483|NCT01333917|"~     Colorectal cancer is a major problem in the United States and other developed countries. A~     safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia.~     Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of~     years as a traditional remedy. Curcumin blocks a number of targets involved in tumor~     initiation, promotion, and progression, and is considered a promising chemopreventive agent.~     The investigators propose to enroll 40 patients after screening colonoscopy who will have~     rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators~     will use microarray analysis to identify genes that are modified by curcumin that could be~     used as biomarkers in future chemoprevention studies. The study will also evaluate~     tolerability and toxicity.~   "
170484|NCT01333904|"~     The purpose of this study is to establish single and multiple dose safety in healthy subjects~     and subjects with mild chronic pulmonary obstructive disease (COPD). In addition, the study~     will evaluate preliminary proof of concept endpoints in COPD subjects such as biomarkers in~     sputum and mucociliary clearance.~   "
170485|NCT01333891|"~     Age-related macular degeneration (AMD) and glaucoma are among the leading causes of blindness~     in the western world. Elevated intraocular pressure (IOP) is a well known major risk factor~     for glaucoma. In addition, there is growing evidence that vascular factors, including~     arterial hypertension and hypotension, may play a role in the pathogenesis of AMD and~     glaucoma. To gain more insight into these mechanisms in humans is the primary goal of the~     present study.~      Optical coherence tomography (OCT) delivers three dimensional, volumetric reflectivity~     information through transparent media in vivo. Moreover, the images show a high choroidal~     penetration and a resolution comparable to an histologic examination when infrared light~     sources are used. Because of its non-invasive character, OCT provides an ideal method for~     diagnosis and monitoring of retinal and choroidal abnormalities.~      The present study aims to investigate whether choroidal thickness is temporarily altered by~     changes in IOP or systemic hemodynamic parameters. IOP will be increased by the use of a~     suction cup technique, mean arterial blood pressure will be altered by intravenously~     administered Phenylephrine or Sodium-Nitroprusside.~   "
170486|NCT01333878|"~     The hypothesis of this study is that subcutaneous Abatacept is effective in reducing synovial~     inflammation, osteitis, and erosions in Rheumatoid Arthritis as assessed by low field~     extremity MRI and X-ray.~   "
170487|NCT01333865|"~     The main objective of this study is to evaluate the safety and effectiveness of memantine~     (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism~     spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine~     whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The~     study results will be used to generate hypotheses for a larger randomized controlled clinical~     trial with explicit hypotheses and sufficient statistical power.~   "
170488|NCT01333852|"~     Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized~     phase II trial~   "
170489|NCT01333839|"~     In this study, the investigators want to examine the impact of coronary artery bypass graft~     (CABG) surgery on skeletal muscle mass, muscle metabolism, and insulin sensitivity in 90~     subjects. In extent, the impact of a subsequent exercise intervention will be examined, with~     a follow-up up to 12 months after surgery.~   "
170490|NCT01333826|"~     This study is designed to evaluate a two-year randomized intervention in Malawi that provides~     cash transfers to current schoolgirls (and young women who have recently dropped out of~     school) to stay in (and return to) school in order to understand the possible effects of such~     programs on the sexual behavior of the beneficiaries and their subsequent HIV risk.~   "
170491|NCT01333813|"~     This study will evaluate the persistence of immunity to hepatitis B in healthy children aged~     7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life,~     and also their ability to mount an immune response to the challenge dose of Engerix-B™~     Kinder.~   "
170492|NCT01333800|"~     The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and~     Beclomethasone in pediatric asthma control.~   "
170493|NCT01333787|"~     The purpose this study was to to evaluate the therapeutic effect of a fibers mixture in the~     treatment of chronic constipation and on the colonic transit time in children.~   "
170569|NCT01332799|"~     Cardiovascular disease is the leading cause of mortality in kidney transplantation. The~     enzyme xanthine oxidase may play an important role in the cardiovascular disease of kidney~     transplant recipients. Inhibiting this enzyme with allopurinol may improve vascular health~     and protects against cardiovascular complications.~   "
170494|NCT01333774|"~     It has been recently suggested, that not the diet by itself, but also patient's adherence to~     dietary recommendations and all actions performed to improve dietary compliance, may be a~     significant factor influencing blood glucose control. There are no clinical data on the~     influence of different approaches to dietary advising on the effects of acarbose treatment in~     obese diabetic patients under real-life setting in Poland. Thus, the aim of this study was to~     assess the influence of different approaches to dietary advisory on the effects of acarbose~     treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to assess~     the influence of different approaches to dietary advising on the appearance of potential~     adverse events in acarbose treated obese DM patients.~   "
170495|NCT01333761|"~     The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green~     (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the~     presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against~     transesophageal echocardiography (TEE) for sensitivity and specificity, as well as~     transcranial doppler (TCD) for positive percent agreement and negative percent agreement.~   "
170496|NCT01333748|"~     The purpose of this study is to determine proportion of patients presented a search allelic~     imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or~     ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes~   "
170497|NCT01333735|"~     The aim of the study is to investigate the impact of adjuvant chemotherapy on cognitive~     function in patients aged over 65 and suffering from breast cancer or colon.~   "
170498|NCT01333722|"~     The primary purpose of this study was to evaluate analgesic efficacy and safety of~     hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate~     to severe pain following bunionectomy.~   "
170499|NCT01333709|"~     The purpose of this study is to determine whether the tailored management of locally advanced~     rectal carcinoma can improve the oncologic and functional outcome.~   "
170500|NCT01333696|"~     The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as~     salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and~     neck.~   "
170501|NCT01333683|"~     Many authors link tinnitus to arterial hypertension. The aim of this study is to establish a~     possible relationship between them, analyze the severity of tinnitus related to arterial~     hypertension and analyze a possible influence of ototoxic drugs used to treat arterial~     hypertension~   "
170502|NCT01333670|"~     The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution~     compared with standard isotonic solution on infammation reduction and wound bed cleansing of~     chronic pressure or vascular leg ulcers.~   "
170503|NCT01333657|"~     Triggering receptor expressed on myeloid cells-1 is a member of the immunoglobulin~     superfamily of receptors that is specifically expressed on the surfaces of monocytes and~     neutrophils.TREM-1 expression is increased in infectious diseases and is associated with the~     release of soluble TREM-1 (sTREM-1).There has been demonstrated that the value of plasma~     sTREM-1 levels as an indicator of sepsis was superior, although other studies reported that~     the value of sTREM-1 for diagnosing sepsis was inferior.An increasing number of studies~     indicate that there are increased levels of sTREM-1 in body fluid samples for the following~     diseases and conditions: sepsis, pneumonia, pleural effusion, septic arthritis, meningitis,~     peritonitis, and uterine cavity infection.~      Inflammation is now believed to play a major role in the pathophysiology of AKI. It is~     hypothesized that the initial insult results in morphological and/or functional changes in~     vascular endothelial cells and/or in tubular epithelium in sepsis models. Then, leukocytes~     including neutrophils, macrophages, natural killer cells, and lymphocytes infiltrate into the~     injured kidneys and induce the generation of inflammatory mediators. Whether urine sTREM-1~     could also be detected and its significance in sepsis and AKI has not been reported yet.~      The present study focused on the value of serum & urine sTREM-1 for sepsis identification,~     severity and prognosis assessments, and potential sepsis-related AKI. We also made~     comparisons between sTREM-1 and WBC counts, serum CRP, serum PCT, urine output,CC SCr, and~     BUN among sepsis patients.~   "
170504|NCT01333644|"~     It is the central hypothesis of the investigators study that HIV disease is a~     pro-inflammatory condition, and that years of inflammation result in premature aging' of the~     immune system (immunosenescence). Just as these changes are thought be causally associated~     with heart disease in the very old,the investigators postulate that these changes will be~     associated with early heart disease in the untreated and perhaps treated HIV disease. To~     address this hypothesis, the investigators will measure immunosenescence in a large cohort of~     patients who span the entire disease process.~   "
170505|NCT01333631|"~     This is non-randomized phase 2 study to evaluate toxicity and efficacy of valproic acid (VA)~     with concurrent chemoradiotherapy (CCRT) containing weekly gemcitabine in patients with~     unresectable locally advanced pancreatic cancer (ULAPC). All patients will be planned for~     three-dimensional conformal radiotherapy (3-DCRT). A total dose of 54 Gy will be delivered~     using 2 Gy daily fractions given over 5 days a week.Intravenous (i.v.) chemotherapy (ChT)~     with gemcitabine 300 mg/m2 will be started at the first day of 3-DCRT.Total 5-6 weekly doses~     of i.v. ChT will be planned.VA will be administered orally in daily dose of 800 mg. Treatment~     with VA will be commenced at the first day and will be terminated at last day of RT.The~     patients will be followed till disease progression or death.~   "
170506|NCT01333618|"~     It has been demonstrated that implantation of inferior vena cava filter was safe and~     effective in the prevention or reduction of fatal pulmonary thromboembolism in numerous~     clinical researches. When acute deep venous thrombosis need transcatheter thrombolysis,~     transfemoral Günther Tulip Filter implantation could avoid catheter across the Günther Tulip~     Filter. Although incidence of significant filter tilting (>10°) is not high (13%-16%), severe~     tilting of the Günther Tulip Filter may be associated with difficulty or sometimes~     impossibility of retrieval. It has been reported that a simple technique of keeping tension~     of the delivery system may prevent significant tilting of the transjugular Günther Tulip~     Filter in an in-vitro study. But no clinical study of prevention transfemoral Günther Tulip~     Filter from tilting has been reported. The investigators conducted a randomized, controlled~     study to test whether the introducer curving technique is useful to decrease the extent of~     tilting of transfemoral Günther Tulip Filter.~   "
170510|NCT01333566|"~     The long-term goal of our research program is to develop an effective and cost-saving~     mind-body therapy to help patients with FM. The objective of this pilot study is to gather~     pilot data of the effect on pain, fatigue, sleep quality, and quality of life in FM patients~     using a specific type of qigong exercise, i.e. six healing sound qigong. Changes in~     relevant brain activity will be monitored in study subjects before and after the qigong~     exercise program, which may help us in better understanding the underlying mechanism of the~     qigong exercise. Data collected in this pilot study will help the investigators in~     preparation for a future clinical trial with a larger sample size. Our central hypothesis for~     the future clinical trial is that qigong exercise will lead to a significantly greater~     improvement in pain, fatigue, sleep quality, and quality of life in the experimental group~     compared to the control group.~   "
170511|NCT01333553|"~     The researcher develop non-invasive imaging modalities for assessment of port wine stain~     during laser therapy treatment of Port Wine Stain. The imaging modalities will be used to~     guide immediate retreatment of regions of persistent perfusion during the procedure.~   "
170512|NCT01333540|"~     A dose-escalation study to assess the safety, tolerability and clinical activity of TD−1211~     in patients with opioid-induced constipation.~   "
170513|NCT01333527|"~     Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is~     done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease~     pain, and to increase range of motion (ROM) and strength. This is done arthroscopically;~     through a small incision in the patient's shoulder. After surgery, patients are usually~     placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this~     time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or~     active shoulder movement is usually not permitted to allow the repaired tendons to heal.~     Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can~     delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a~     slower return-to-work or daily activities, and may also impact the health care system,~     through increased use and cost of rehabilitation.~      This study's purpose is to determine if patients can safely stop wearing their sling as early~     as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will~     be randomly assigned to one of two study groups:~      Patients in Group A (accelerated rehab) will wear their sling for comfort only following~     surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may~     stop wearing their sling if pain and comfort allow, and start active movement for activities~     of daily living only.~      Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A,~     self-assisted ROM exercises are allowed at any time, but active movement will not be allowed~     until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM~     exercises after surgery.~      Patients who agree to participate in the study will see their surgeon and the study physical~     therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months~     post-surgery). Each visit will take about 30 minutes and will include a ROM assessment,~     strength assessment (as appropriate) and disease-specific quality of life questionnaires.~     Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at~     12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse~     events will be examined between the two groups. Differences will also be examined according~     to RC tear size and patient characteristics.~   "
170514|NCT01333514|"~     Good sugar control in postoperative hospitalized patient has been shown to improve wound~     healing and infection rates. However, sugar control is difficult to achieve and suboptimal~     use of insulin is thought to be a contributory factor. Though it is known that generally the~     consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing~     meal-time insulin is based on the fraction of the total meal-tray eaten which includes~     proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a~     patient who consumes a portion of mainly proteins and fats on their trays or an~     underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high~     blood sugars can follow respectively.~      Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams of~     carbohydrates consumed will result in better sugar control compared to the usual practice of~     dosing meal-time insulin based on percent of total meal consumed in hospitalized patients.~   "
170515|NCT01333501|"~     The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery~     (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the~     slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of~     treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate~     which test of the battery is the most sensitive in detecting differences between treatment~     groups.~   "
170516|NCT01333488|"~     The investigators hypothesize that hypothermia (body cooling) and additional magnesium~     sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.~      This is a study to compare the outcomes of patients with severe traumatic brain injury who~     have been allocated to one of the following three groups:~      Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have~     their core body temperature lowered to 34C Group 3 - Subjects will have their core body~     temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium~     sulfate.~   "
170517|NCT01333475|"~     Background:~      - MK-2206 and AZD6244 (Selumetinib) are experimental cancer treatment drugs that block the~     effect of certain proteins that cancer cells need to grow and survive. These drugs may be~     effective treatments for some types of colorectal cancer that has not responded to or has~     relapsed after standard treatment. Researchers are interested in studying how MK-2206 and~     AZD6244 affect levels of certain proteins in colorectal cancer tumor, and how well the drugs~     work against cancer cells by examining cells from a tumor sample collected before the drugs~     are given and again after the drugs are given.~      Objectives:~      - To evaluate the safety and effectiveness of MK-2206 and AZD6244 in individuals with~     advanced colorectal carcinoma that has not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with advanced colorectal~     carcinoma that has not responded to at least one type of standard chemotherapy.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          and tumor imaging studies.~        -  Participants will take MK-2206 and AZD6244 by mouth for 4-week cycles of treatment, with~          one dose of MK-2206 per week and one dose of AZD6244 every day. (If participants have~          negative side effects from the medications, the doses will be adjusted to a smaller~          dose). Participants will keep a diary to record doses and keep track of any side~          effects.~        -  During treatment, participants will have regular visits to the clinical center,~          involving blood and urine tests, tumor biopsies, and other examinations to monitor the~          effects of treatment. Participants will have imaging studies every two cycles (8 weeks)~          to study the cancer's response to the treatment.~        -  Participants will continue to have cycles of treatment for as long as the treatment~          continues to be effective and the side effects are not severe enough to stop~          participation in the study....~   "
170518|NCT01333462|"~     The purpose of this study is to test the safety and immune response of a new intranasal~     vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that~     is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a~     vaccine work better), called W805EC.~   "
170570|NCT01332786|"~     The purpose of this study is to determine whether tigecycline is safe and which dosage is~     most effective in the treatment of patients with acute myeloid leukemia.~   "
170571|NCT01332773|"~     To show whether the artery first approach leads to equal or less rate of positive resection~     margins in pancreatic head cancer than the standard technique (ppWhipple only with standard~     Kocher's manoeuvre)~   "
170616|NCT01332188|"~     The purpose of this study is to evaluate the efficacy of different concentrations of AC-170~     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in~     the conjunctival allergen challenge (CAC) Model.~   "
170519|NCT01333449|"~     Allogeneic blood stem cell transplant remains the only potential curative treatment for~     myelodysplastic syndromes (MDS) to date. Pre-transplant induction chemotherapy with~     leukemia-type regimens is associated with significant toxicity and even death. The~     hypomethylating agents decitabine and 5-azacytidine have been shown in studies to cause~     improved hematologic parameters and partial or complete responses in patients with high risk~     MDS compared to standard therapy. In contrast to leukemia-type chemotherapy, decitabine is~     associated with a relatively low risk of toxicity. We therefore propose to treat~     transplant-eligible MDS patients with Decitabine as induction therapy and a bridge to~     transplant.~      Hypothesis:~        1. Decitabine is able to reduce disease burden as measured by blood and marrow blast counts~          prior to allogeneic hematopoietic stem cell transplant to below 5%.~        2. Decitabine is well-tolerated by patients with high-risk MDS and will be a safe induction~          agent and bridge prior to allogeneic transplant in transplant-eligible patients.~   "
170520|NCT01333436|"~     This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in~     diabetic participants compared to nondiabetic participants with the same range of serum LDL-C~     levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify~     potential cardiovascular disease risk.~   "
170521|NCT01333423|"~     The goal of this clinical research study is to find the highest tolerable dose of seliciclib~     that can be given in combination with liposomal doxorubicin to patients with metastatic~     breast cancer.~   "
170522|NCT01333410|"~     Vitiligo has remained a difficult disease to treat. Previous available therapies are often~     ineffective. It usually takes several months or years for complete repigmentation and some~     areas of the body get at best only partial repigmentation. The desire of the patient to~     undergo therapy varies from patient to patient and needs to be assessed individually. Several~     factors should be considered when planning the treatment strategies including type of~     vitiligo, site and degree of involvement, skin color, psychological effect, patient~     compliance, ease to assess to therapy, cost of treatment and social association of the~     disease.~      Topical corticosteroids are still be the standard treatment of localized vitiligo. However,~     the adverse effects such as skin atrophy, striae, pigmentary change and~     hypothalamic-pituitary adrenal axis suppression can occur if we use inappropriate strength of~     topical steroids for a long period of time.~      Tacrolimus (FK-506) is a new immunosuppressive agent that acts by inhibiting T-cell~     activation and cytokine release. It offers a safe and efficacious alternative for many skin~     conditions. It minimizes the need for topical glucocorticoids and does not cause skin~     atrophy. Tacrolimus was first reported for treatment of vitiligo in 2002. The underlying~     mechanism was shown in an in vitro study that topical tacrolimus promoted proliferation of~     melanocytes and melanoblasts.~      This study purpose is to evaluate the efficacy and safety of 0.1% topical tacrolimus ointment~     comparing to 0.1% mometasone furoate cream in the treatment of adult vitiligo.~   "
170523|NCT01333397|"~     The primary objective is to assess the dose response versus placebo of a single treatment of~     Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of~     moderate to severe glabellar lines at maximum frown.~   "
170524|NCT01333384|"~     The purpose of this study is to evaluate over the 24 month prospective follow up - in~     everyday clinical practice - resource utilization and effectiveness of the treatment of~     acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection~     intervals.~   "
170525|NCT01333371|"~     Patients will be randomized to volar plating with early ROM versus closed reduction with~     K-wires and 6 weeks of cast immobilization to determine if there is any advantage to volar~     plating in this subgroup of patients with distal radius fractures.~   "
170526|NCT01333358|"~     The main purpose of this research study is to investigate how well a medicine (alemtuzumab)~     works in treating MS-related cognitive problems (e.g., attention, memory, speed of thinking).~     This study will include 30 subjects from six research sites.~      Alemtuzumab is approved and sold under the brand names Campath and MabCampath to treat some~     types of leukemia. As a leukemia treatment, it is given more often and at much higher doses~     than in this study.~   "
170527|NCT01333345|"~     The purpose of this study is to obtain data on the performance of the EC-3 lens at an~     interval of two years (and beyond) from subjects who were implanted. The primary aim of the~     study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies~     in the subjects.~   "
170528|NCT01333332|"~     The purpose of this study is to determine safety and to obtain preliminary estimates of the~     rate of major pathologic response of neoadjuvant accelerated fraction, standard dose~     radiation given with chemotherapy in patients with locally advanced pancreas cancer.~   "
170529|NCT01333319|"~     Renal dysfunction is a major risk factor for poorer outcome after liver transplantation.~     Nevertheless, mechanisms of renal dysfunction in liver transplant recipients are not clearly~     understood. Calcineurin inhibitors are generally perceived as the most important cause;~     however the liver transplant procedure itself represents a major surgical / hemodynamic /~     inflammatory trauma that - on its own - can cause renal dysfunction. Creatinine and~     creatinine clearance are late markers of acute kidney injury and changes in these parameters~     occur only after substantial injury has already occurred. Even a stable creatinine does not~     exclude structural kidney damage.~      A series of new markers of tissue injury have been identified and have the potential to~     identify acute kidney injury better and earlier than creatinine and creatinine clearance. The~     aim of this study is to determine whether and how liver transplantation affects these urinary~     and plasma biomarkers and to study whether the changes in these biomarkers may predict later~     changes in standard functional parameters (creatinine and creatinine clearance). For this~     purpose, the urinary and plasma biomarkers, together with creatinine, will be determined~     serially during the different phases of the liver transplant process and daily until day 5~     after transplantation.~   "
170572|NCT01332760|"~     Dentists and dental hygienists experience elevated rates of musculoskeletal disorders, such~     as carpal tunnel syndrome and tendonitis, primarily due to the high pinch force required for~     dental scaling. There is evidence that a lighter and larger diameter tool can significantly~     reduce the pinch force. This randomized controlled study will determine if dentists or dental~     hygienists who use such a tool report less hand and arm pain compared to those who continue~     to use the conventional tool design.~   "
170530|NCT01333306|"~     Cognitive rehabilitation involves enhancing an individual's capacity to process information~     to improve their everyday functioning. One common form of intervention is computerised~     cognitive training (CT); however, efficacy results have been mixed. This research aims to~     investigate a novel method for enhancing outcomes from CT through combining CT with~     transcranial direct current stimulation (tDCS), a non-invasive and painless form of brain~     stimulation. In this study we aim to determine the efficacy of this approach through~     comparing in a randomized controlled study tDCS combined with CT versus CT and tDCS alone in~     healthy participants. We hypothesise that tDCS combined with CT will have greater~     generalisability effects than the other conditions.~   "
170531|NCT01333293|"~     Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo,~     fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by~     mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid~     reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast media,~     local anesthetics or analgesics. In addition, there is increased osteoporosis in mastocytosis~     patients due to the activity of mast cell mediators on osteoblasts and osteoclasts. Symptoms~     of mastocytosis respond poorly to treatment with antihistamines or other antiallergic drugs.~     There is currently no specific treatment for this disease with the exception of rare cases.~     There are, however, some case reports suggesting that omalizumab might decrease symptoms~     including hypotensive events.~      The aim of the study is to investigate whether patients suffering from mastocytosis benefit~     from a 6 month course of omalizumab with regard to symptoms and quality of life and whether~     the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the~     efficacy of omalizumab in patients with mastocytosis.~        -  Trial with medicinal product~   "
170532|NCT01333280|"~     The purpose of the study is to determine whether adding dual focus mutual aid groups to~     formal treatment for people dually diagnosed with substance abuse and mental illness is~     effective in improving treatment outcomes.~      NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE PARTICIPATING TREATMENT~     PROGRAMS.~   "
170533|NCT01333267|"~     This is a dose escalation study to determine the maximum tolerable dose of Parathyroid~     Hormone-related Protein, PTHrP, or Parathyroid Hormone, PTH, that can be given safely over~     one week in healthy African-American volunteers. The investigators plan to infuse low doses~     of intravenous PTHrP or PTH to determine if it leads to a sustained and progressive~     suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an~     increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the~     investigators will assess the direct influence of PTHrP and PTH on vitamin D metabolism,~     markers of bone turnover, and fractional excretion of calcium. These results will be compared~     to previous studies of Caucasian volunteers.~   "
170534|NCT01333254|"~     The aim of the project is to evaluate differences between intermittent and indwelling~     catheterisation in patients with hip surgery.~      Specific objectives are to determine whether:~        -  frequencies of urinary tract problems in hospital and up to one year after discharge~          differ between patient groups treated with intermittent and indwelling catheterisation~          respectively.~        -  costs and health-effects differ between the patient groups.~        -  experiences of urinary catheterisation differ between the patient groups~   "
170535|NCT01333241|"~     The overall goal of this randomized controlled trial is to evaluate the effects of a~     community-based lifestyle behavior intervention (LSBI) that is designed to improve diet,~     reduce weight and increase physical activity (PA) of Latino women who are predominantly~     Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas~     participating in a LSBI conducted by promotoras will demonstrate a greater decrease in BMI~     and a higher increase in physical activity than those in a control condition, Women in the~     LSBI also are expected to demonstrate improvements in selected physiologic outcomes (blood~     pressure [BP], measures of cholesterol and blood sugar, waist circumference), and~     self-reported lifestyle behaviors (diet, PA). of these participants are also e~   "
170536|NCT01333228|"~     Endothelial Progenitor Cells (EPC) represent a small cellular population of bone marrow and~     peripheral blood cells. EPCs are recruited into injured tissues and play an important role in~     regeneration and reparation. Experimental and clinical data suggest that EPCs have~     hepatoprotective activity and could improve liver regeneration during acute and chronic liver~     injury. The aim of this project is to evaluate the safety and therapeutic effects of~     autologous bone marrow-derived EPCs, when administered through the hepatic artery of patients~     with advanced liver cirrhosis.~   "
170537|NCT01333215|"~     The purpose of this study is to compare the cognitive inhibition deficit among depressed~     older suicide attempters compared to depressed older suicide non-attempters.~   "
170538|NCT01333202|"~     The purpose of this study is to determine whether fresh lime alone is effective for smoking~     cessation.~   "
170539|NCT01333189|"~     The purpose of this study is to determine if rehabilitation using weight-bearing biofeedback~     training following total knee arthroplasty (TKA) is more effective than standard~     rehabilitation methods in promoting weight-bearing symmetry through the lower limbs during~     functional activities such as sit-to-stand transfers and walking. Secondary outcomes of~     interest include functional measures and internal moment at the hip, knee, and ankle joints~     during sit-to-stand and walking.~   "
170540|NCT01333176|"~     1. Purpose~             -  to estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a~               BC First Nation community~             -  to determine the utility of community based screening by examining how many~               positively screened people follow up with the recommended subsequent testing and~               family physician visit~             -  to determine if point-of-care HbA1c test (Ames/Bayer DCA 2000) correlates with the~               confirmatory fasting and 2 hour post challenge blood glucose tests.~        2. Hypothesis The Point-of-Care test will correlate well with the gold standard diagnostic~          tests and prove to be a useful tool for community-based screening. This test obviates~          the need for fasting and repeat glucose tolerance testing.~   "
170541|NCT01333163|"~     The purpose of this study is to investigate how Glucagon-Like Peptide 1 (GLP-1) affects~     kidney function in healthy young men. The hypothesis is that GLP-1 induces a positive effect~     on kidney hemodynamics.~   "
170542|NCT01333150|"~     The project's primary purpose is to test the hypothesis that oral administration of a low~     single dose of β-antagonist propranolol (40 mg) reduces pain sensitivity in patients with~     masticatory muscle pain.~   "
170546|NCT01333098|"~     This study seeks to develop and test a novel, mechanistic treatment for mitigating cognitive~     impairment in older adults with anxiety disorders. Anxiety disorders are common, severe, and~     disabling in older adults. One particularly impairing aspect of late-life anxiety disorders~     is cognitive impairment: impairments in memory and executive function cause disability,~     impede treatment response to psychotherapy, may lead to dementia, and are not corrected by~     standard anti-anxiety treatments.~      This pilot study will test the glucocorticoid antagonist, mifepristone, for cognitive~     impairment in late-life anxiety disorders. Mifepristone blocks the effects of elevated~     cortisol levels on glucocorticoid receptors in the brain; it has been studied preliminarily~     in various neuropsychiatric disorders, such as psychotic depression and bipolar disorder,~     with well-documented safety and tolerability.~   "
170547|NCT01333085|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving~     everolimus together with carboplatin and paclitaxel in treating patients with locally~     advanced head and neck cancer that cannot be removed by surgery.~   "
170548|NCT01333072|"~     The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will~     provide evidence-based guidance in the selection and monitoring of drug treatment of autism.~     BAART involves 3 academic centers across South Carolina. Although the FDA has approved use of~     the antipsychotic drug risperidone for irritability associated with autistic disorder, a~     moderate response rate in pivotal clinical trials and concerns over tolerability and weight~     gain can force clinicians to select alternative drug treatments for which evidence-based~     support is sparse.~   "
170549|NCT01333059|"~     The purpose of this study is to determine if the reduction of the total amount of sedative~     critically pediatric ill patients receive in the PICU will achieve a significant decrease in~     mechanical ventilation days and a decrease in the overall length of stay in the PICU and~     hospital.~   "
170550|NCT01333046|"~     Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has~     come back, or may come back, or has not gone away after treatment, including the standard~     treatment known for these diseases. This a research study using special immune system cells~     called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental~     therapy.~      This sort of therapy has been used previously to treat Hodgkin or non-Hodgkin lymphomas that~     show proof of infection with Epstein-Barr virus (EBV), the virus that causes infectious~     mononucleosis (mono or the kissing disease). EBV is found in cancer cells of up to half~     of all patients with Hodgkin's and non-Hodgkin lymphoma. This suggests that it may play a~     role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's~     immune system and escape being killed. Investigators tested whether special white blood~     cells, called T cells, that were trained to kill EBV-infected cells could affect these~     tumors, and in many patients it was found that giving these trained T cells caused a complete~     or partial response.~      However, many patients do not have EBV in their lymphoma cells; therefore investigators now~     want to test whether it is possible to direct these special T cells against other types of~     proteins on the tumor cell surface with similar promising results. The proteins that will be~     targeted in this study are called tumor associated antigens (TAAs) - these are cell proteins~     that are specific to the cancer cell, so they either do not show or show up in low quantities~     on normal human cells.~      In this study, we will target five TAAs which commonly show on lymphoma, called: NY-ESO-1,~     MAGEA4, PRAME, Survivin and SSX. This will be done by using special types of T cells called~     cytotoxic T lymphocytes (CTLs) generated in the lab.~      In addition, some adult patients will receive a drug called azacytidine before giving the T~     cells. We hope that the combination helps the T cells work better.~   "
170551|NCT01333033|"~     RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to~     treatment and help plan the best treatment.~      PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in~     patients with esophageal cancer receiving combination chemotherapy.~   "
170552|NCT01333020|"~     This comparative pilot study is designed to compare the rates of gastric emptying and by~     inference rates of digestion of two food emulsions. Two types of milk protein stabilised food~     emulsion will be compared, one standard emulsion preparation and one emulsion preparation~     cross-linked with microbial transglutaminase. The information from this study will then be~     compared to data on satiety and endocrine hormones from a parallel study undertaken in~     Finland using the same two meal formulations. The drinks will be labeled with a stable~     isotope of carbon and samples of breath collected every 20 minutes after consumption of the~     drink. This will allow gastric residence time to be calculated. The pilot will also fulfill~     two secondary objectives. At the same time as the breath samples are collected MRI scans of~     the upper abdomen will be made so that gastric volumes can be measured in order to compare~     the two methods of measuring gastric emptying rates. Additionally, samples of saliva will~     also be collected after every MRI scan for subsequent mass spectrometry analysis. These are~     to assess the efficacy of mass spectrometry analysis for detection of the presence of~     specific digestion related hormones such as ghrelin.~   "
170553|NCT01333007|"~     This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab)~     as first-line treatment in combination with chemotherapy in patients with inoperable~     advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical~     practice. Data will be collected for each patient for 18 months from initiation of Avastin~     therapy.~   "
170554|NCT01332994|"~     This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate~     the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid~     arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12~     weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate~     clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g~     MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study~     treatment is 32 weeks.~   "
170555|NCT01332981|"~     This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin~     (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of~     treatment.~   "
170573|NCT01332747|"~     The purpose of this clinical trial is to study the comparative effect of a classical unani~     antiobesity drug safoof-e-muhazzil on hyperlipidemia in its classical powder form and in~     compressed tablet form against a standard control.~   "
170574|NCT01332734|"~     During infections (sepsis) bloodflow in small vessels (microcirculation) becomes disturbed.~     Restoration of bloodpressure and cardiac performance may not be sufficient to correct these~     alterations. Magnesium is a potent vasodilator which may be used to open up the small~     vessels, in order to reduce organ failure.~   "
170556|NCT01332968|"~     This open-label, randomized study will assess the efficacy and safety of obinutuzumab~     (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with~     chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated~     advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants~     achieving response (Complete response [CR] or partial response [PR]) will undergo a~     maintenance period continuing on the randomized antibody treatment alone every 2 months until~     disease progression for a total of 2 years. Anticipated time on study treatment is up to~     approximately 2.5 years. After maintenance or observation, participants will be followed for~     5 years until progression. After progression, participants will be followed for new~     anti-lymphoma therapy and overall survival until the end of the study.~   "
170557|NCT01332955|"~     This phase II, multicentric, national pilot trial is designed to estimate the sustained~     virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a~     48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological~     response (RVR) at week 8 (4 weeks after telaprevir start), and to compare the observed SVR to~     20%, a rate determining a significant therapeutic benefit in this population of patients. The~     primary endpoint will be the SVR defined as undetectable HCV-RNA measured 24 weeks after the~     end of therapy (EOT).~   "
170558|NCT01332942|"~     The drug that is under investigation during this study is BAY85-3934 which is intended to be~     used as a treatment for patients suffering from renal anemia due to chronic kidney disease~     (stage 3 and 4).~      The purpose of this study is to provide safety and tolerability information on the drug.~     Other objectives of the study are to investigate the effect of the drug on the body~     (pharmacodynamics) as well as the absorption, breakdown, metabolism, distribution and~     excretion (pharmacokinetics) by measuring the concentration in blood and urine.~      The study will be conducted in one study center in the United Kingdom and several centers in~     Germany. 84 (of which 36 are optional) patients who meet the inclusion criteria will~     participate in the study. BAY 85-3934 will be given following a combined single / multiple~     dose escalation design in seven (of which three are optional) dose steps.~   "
170559|NCT01332929|"~     This phase I pilot study aims to define the safety of a combined treatment of bevacizumab and~     whole brain radiation therapy for the treatment of patients with brain metastasis of solid~     tumors. If this therapeutic scheme confirms it's safety profile, the investigators can~     expect:~        -  first, to allow that all patients can receive bevacizumab for their advanced and/or~          metastatic cancer if necessary, even in case of brain metastasis.~        -  Secondly, if this trial confirm a synergic effect of the combination of angiogenesis~          inhibitors and brain radiotherapy for local control of brain metastasis, an improvement~          of the therapeutic results for these patients which have a poor hope of survival and for~          which none innovative approach is currently suggested.~      Moreover, the investigators hope that the analysis of the different data of MRI evaluation -~     morphological and functional - will allow better definition of radiological evaluation of the~     therapeutic effect of angiogenesis inhibitors on brain metastasis.~   "
170560|NCT01332916|"~     The purpose of this study is to investigate memory problems in patients with cancer.~   "
170561|NCT01332903|"~     This is a phase I, open label, healthy volunteers, ADME study with single oral administration~     of [14C] AZD5069.~   "
170562|NCT01332890|"~     To evaluate drug-drug interaction~   "
170563|NCT01332877|"~     EFFECT OF HIGH CARBOHYDRATE AND HIGH PROTEIN BREAKFAST ON WEIGHT LOSS, GHRELIN, HUNGER AND~     CRAVING SCORES IN OBESE MEN AND WOMEN. D Jakubowicz, M Boaz, J Wainstein, O Froy~      Background: Obesity underlying endocrine, metabolic and eating behaviour features promotes~     weight gain, increase of hunger, and carbohydrate (Carb) craving. Restrictive diets either in~     calories or Carb produce withdrawal effect, that further exacerbate Carb craving resulting in~     rapid return of obesity. Meal timing and composition has shown to play a pivotal role in~     appetite regulation through several hormonal systems such as ghrelin. The investigators~     hypothesized that to be successful; a weight loss strategy must change the hormonal~     environment to increase satiety while reducing hunger and craving.~      Objectives: To assess weight loss, satiety, hunger, cravings and ghrelin response to two~     isocaloric diets. Additionally, these outcomes were measured in response to meal challenge.~      Methods: In this randomized, treatment controlled clinical trial, 146 obese, sedentary adults~     with impaired glucose tolerance will be assigned to Low carb diet (LCHbd) or an isocaloric~     diet with a high carb, high protein breakfast (HCPbd),1400 kcal for women and 1600 kcal for~     men. LCHbd breakfast will provide 300 kcal with carb: protein: fat of 13:40:48. HCPbd~     breakfast will provide 600 kcal with 50:20:30. From baseline until week 16 participants will~     take part in a supervised weight loss diet, followed until week 32 by a maintenance period.~     Anthropometric measures, OGTT for glucose and insulin, VAS-measured hunger and satiety and~     Food Craving Inventory Analysis will be performed at baseline, week 16 and week 32.~   "
170564|NCT01332864|"~     Participants with chronic or recurrent headache, unrelated to any known pathology or disease,~     will be randomly assigned to one of four interventions: Osteopathic manipulation of the body~     other than the head, osteopathic manipulation of the head, osteopathic manipulation of the~     head and rest of the body, or light touch on the head only but no manipulation. Measurements~     of heart rate and blood pressure variability, peripheral blood flow, and behavioral changes,~     such as mood, pain duration, intensity and frequency will be assessed.~   "
170565|NCT01332851|"~     The study evaluates the feasibility and effectiveness of a well-documented relationship-based~     intervention (Promoting First Relationships), compared to a resource and referral condition,~     in improving outcomes for families of infants and toddlers referred to Child Protective~     Services (CPS) for maltreatment. In addition, it evaluates the effectiveness of training~     community social service workers in providing the intervention.~   "
170566|NCT01332838|"~     The purpose of this study is to determine if the use of specialized compression garments, in~     comparison to standard compression, improves early patient outcomes after endovenous~     ablation.~   "
170567|NCT01332825|"~     The purpose of this study is to determine the normal distribution of nasal tissue~     cathelicidin antimicrobial peptides (cAMP) levels in subjects with normal smell and subjects~     with smell dysfunction. The investigators will also look at the effect of nasal saline~     irrigation on olfaction and cAMP levels and if nasal irrigation is capable of harvesting~     olfactory cilia. The investigators hypothesize that nasal saline will have no effect on~     olfaction and will be inadequate to harvest olfactory cilia.~   "
170577|NCT01332695|"~     This study will look at the ability of ST101 to treat symptoms in subjects with Essential~     Tremor. This study will also examine the safety and tolerability of the drug. This study is~     evaluating one dose level of ST101 versus placebo in a cross-over fashion. This means that~     all patients will receive both ST101 and placebo, but they will receive it in a random (by~     chance) order.~   "
170578|NCT01332682|"~     The purpose of this feasibility study is to examine the safety and effect of resistance~     training on muscle strength, lean body mass, physical functioning, fatigue, and quality of~     life in head and neck cancer patients receiving radiation therapy.~   "
170579|NCT01332669|"~     In unresectable hepatocellular carcinoma, TACE using Lipiodol/anti cancer agent emulsion is~     the standard treatment and reported as a significantly better treatment through randomized~     comparison study like Llovet, etc. than conservative treatment. Recently, doctors do~     transarterial chemoembolization with drug-eluting bead, and it is proved less side effect and~     better efficacy than conventional TACE using Lipiodol in Precision V study by Dr. Lammer,~     etc. But, it could not defined improved survival rate as expected. This study's purpose is~     evaluating treatment efficacy, survival rate and safety of TACE using drug eluting bead by~     comparing to conventional TACE using doxorubicin/Lipiodol emulsion for unresectable~     hepatocellular carcinoma.~   "
170580|NCT01332656|"~     Primary Objective:~      - To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus~     placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with~     paclitaxel and carboplatin.~      Secondary Objectives:~        -  To compare the overall survival (OS) between the 2 treatment arms~        -  To compare the objective response rate (RR) between the 2 treatment arms~   "
170581|NCT01332643|"~     This study evaluates the effect of single embryo transfer (SET) with and without array CGH~     for the evaluation of the complete chromosome complement of the blastocyst. Patients will be~     allocated at random into two groups. The control group will consist of patients in which one~     embryo will be replaced on day 5 based on morphological and developmental characteristics,~     and the other embryos reaching blastocyst stage will be vitrified. The test group will~     consist of patients undergoing embryo biopsy at the blastocyst stage (day 5 of development,~     embryo freezing, and analysis of the biopsied cells with a comprehensive chromosome analysis~     technique (array Comparative Genome hybridization or aCGH). Only a chromosomally normal~     blastocyst will be replaced in a thawed cycle. Inclusion and exclusion criteria are described~     in the study population section.~   "
170582|NCT01332630|"~     The goal of the first part of this clinical research study is to find the highest tolerable~     dose of TPI-287 in patients with breast cancer that has spread to the brain.~      The goal of the second part of this study is to learn if TPI-287 can control breast cancer~     that has spread to the brain. The safety of this drug will also be studied.~   "
170583|NCT01332617|"~     The purpose of this study test the hypothesis that the combination of simvastatin and~     zoledronic acid (for reversal of drug resistance), with bortezomib, high-dose~     methylprednisolone and bendamustine on a day 1,8 schedule (to reduce toxicity) will be an~     effective and well-tolerated treatment for relapsed and refractory multiple myeloma~   "
170584|NCT01332604|"~     This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the~     safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with~     capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients~     with advanced or metastatic solid tumors.~   "
170585|NCT01332591|"~     The aim of the study is to find the optimal management of patients with acute myocardial~     infarction with ST elevations treated by primary PCI who have at least one significant~     stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence~     of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during~     the follow up of 24 months in group of patients treated with staged revascularization (PCI or~     CABG) in comparison with patients treated conservatively.~   "
170586|NCT01332578|"~     The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma~     faster than standard paracetamol tablets. The study will also assess the gastrointestinal~     transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is~     postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a~     greater early exposure compared to standard paracetamol tablets. In addition, the~     pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.~   "
170587|NCT01332565|"~     This study is a Phase 1, open label, non-randomized, single dose study to determine~     pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral~     administration in healthy Japanese subjects. A total of 10 healthy Japanese subjects will be~     enrolled in this study to receive a 50 mg single dose of DTG. Subjects will have a screening~     visit within 30 days prior to the administration of study drug, a treatment visit, and a~     follow-up visit 7-14 days after the administration of study drug.~   "
170588|NCT01332552|"~     GSK2485852 is a Hepatitis C NS5B site IV non-nucleoside polymerase inhibitor being developed~     for the treatment of chronic HCV infection. HBI115040 is the first administration of~     GSK2485852 in humans to establish the initial safety, tolerability, pharmacokinetic, and~     antiviral profile. The study design is a fusion of single and repeat dosing cohorts in HCV~     infected subjects to evaluate the safety, pharmacokinetics, and antiviral activity of~     GSK2485852.~      HBI115040 describes a Phase I, randomized, double-blind, placebo-controlled, dose escalation~     fusion study to determine the safety, tolerability, pharmacokinetic, and antiviral profile of~     GSK2485852 in single doses (Part 1), repeat doses (Part 2), and ritonavir co-administration~     (Part 3) in chronically infected HCV subjects. The study will also explore the effect of a~     moderate (30%) fat meal on pharmacokinetic endpoints in HCV subjects in Part 1.~   "
170589|NCT01332539|"~     observational, non-interventional study in 120 patients with drug-resistant partial epilepsy,~     comprising two phases: a 3-month retrospective and a 6-month prospective. As control group,~     120 patients with controlled partial epilepsy will be enrolled. The objective of the study is~     to describe the burden of illness in this epileptic population both in terms of costs and of~     quality of life. Costs and quality of life will be also compared between the two populations.~   "
170617|NCT01332175|"~     Randomised, placebo-controlled trial of continuous positive airway pressure therapy (CPAP)~     versus Provent® and Placebo-Provent® to define the effects of Provent® on the severity of~     obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.~   "
170590|NCT01332526|"~     Fructose intake from added sugars has increased dramatically over the last century and has~     recently been implicated as potential contributor to metabolic syndrome, obesity,~     hypertension, inflammation and kidney disease. Fructose differs from the other sugars~     because, uric acid is generated during its metabolism. Serum uric acid levels have been found~     to correlate with the intake of fructose and added sugars. In turn, an elevated serum uric~     acid has also been shown to be associated with increased risk for cardiovascular and~     metabolic diseases. On the other hand complexity of fructose metabolism in each individuals~     results of the various magnitude of hyperuricemia induced by fructose intake. The magnitude~     of uric acid production in each patient may reflect individual predisposition to endogenous~     urate production in a face of relatively normal fasting uric acid concentration. Therefore~     the oral fructose tolerance test might reveal an occult purine disturbances which plays~     casual role in either metabolic disturbances or organ damage.~      The aim of this study is to see whether is a relationship between fructose induced~     hyperuricemia and metabolic disturbances , inflammatory state and organ damage in obese and~     various stages CKD patients.~   "
170591|NCT01332513|"~     This is an open-label, single centre, repeat dose, up- titration study in healthy male and~     female subjects to assess the pharmacokinetic (PK) performance of five prototypes of~     ezogabine modified release tablet formulations.~      The study will consist of a screening period, a treatment phase (consisting of a titration~     phase, bioavailability phase and food effect phase) and a post-treatment follow-up visit. The~     study duration from screening to follow up will be approximately 7 weeks. No study procedures~     will start before informed consent is obtained. Subjects will remain in the clinical unit for~     the duration of the treatment period (35 days).~      Subjects will receive repeat doses of ezogabine for up to 34 days starting at a dose of 100~     mg IR TID (300mg TDD) with a standard meal (to be consumed 30 min prior to dosing) for Days~     1-3, on days 4-6 subjects will receive 150mg IR TID (450mg TDD). On Day 7 through to the end~     of the study subjects will receive ezogabine (Mr or IR) at a dose of 600mgTDD.~      On Day 7 subjects will enter into a 6-way cross over period to investigate the 5 MR~     formulations being tested (each at 300mg BID) and the single IR formulation (at 200mg TID).~     Subjects will receive each formulaition for 4 days and blood samples for pharmacokinetic~     analysis will be collected up to 24 hours post dose on each 4th day (PK days).~      On Day 31 subjects will enter into a food effect phase to investigate the 5 MR formulations~     being tested (each at 600mg QD). Subjects in this period will have a PK day on Day 33~     (following a standard breakfast), and on Day 34 (following a high fat breakfast) to~     investigate a food effect on the PK profile of ezogabine.~   "
170592|NCT01332500|"~     The purpose of this retrospective claims database study was to compare the change in~     migraine-related prescription (i.e. NSAIDs, Opioids, Ergots) utilization among migraine~     suffers following initiation of Treximet ™ (sumatriptan/naproxen) compared with subjects~     initiating treatment with other orally available triptans. The study was used to validate the~     migraine-related prescription utilization patterns predicted by the Treximet ™ Budget Impact~     Model.~      The SourceLx dataset from the family of Wolters Kluwer databases was used for this analysis.~     The database contains 30% of prescription claims filled in the United States (US),~     approximately 160 million patient lives. The data has broad representative coverage at both~     the geographic and payment levels.~   "
170593|NCT01332487|"~     This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase~     inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of~     acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as~     prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized~     for this study (2000-2008).~   "
170594|NCT01332474|"~     To collect the background characteristics of juvenile cerebral palsy patients aged 2-year or~     older prescribed BOTOX for the treatment of equines foot due to lower limb spasticity,~     compare them with those of patients whose deaths or adverse drug reactions (ADRs) related to~     the possible spread of toxin are reported through the spontaneous ADR reporting system, and~     discuss potential risk factors for such ADRs.~   "
170595|NCT01332461|"~     This was a retrospective cross-sectional database study using administrative data (study~     period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged >40 years) having at least~     one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and~     496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index~     event) during the study period was the target population. All subjects were required to have~     one year of pre-index period baseline data. COPD events of interest were ER, Hospital and~     physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days.~     Other censoring events were treatment switch; loss of enrollment; >60-day gap between~     medication fills; or end of study period.~      This study is a non descriptive hypothesis testing study. Key study hypotheses are listed~     below.~      Specifically the study hypotheses for the primary outcome being tested were:~      Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha:~     There is a difference in risk of COPD-related hospitalization between FSC and OMT~      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:~      Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a~     difference in COPD-related costs between FSC and OMT~   "
170596|NCT01332448|"~     Roche and GSK will carry out a meta-analysis of liver function data from trials of orlistat~     to establish whether there is any indication of liver toxicity. The motivation is a~     cumulative assessment of drug-induced liver injury (DILI) conducted by the FDA following~     spontaneous reports of liver toxicity in people taking Xenical or Alli.~   "
170597|NCT01332435|"~     This retrospective study aims to assess the economic impact of early initiation of~     5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving~     5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information~     Solutions and PharMetrics databases will be utilized for this study (2000-2007).~   "
170618|NCT01332162|"~     The purpose of this study is to evaluate the benefit of the optimal pacing configuration,~     including the possibility of biventricular or left ventricular pacing, in hypertrophic~     obstructive cardiomyopathy patients.~   "
170954|NCT01327690|"~     PTSD (posttraumatic stress disorder) and associated mental health conditions affect both~     veterans and their family members. This study investigates whether group therapy using EFT~     (Emotional Freedom Techniques) and CBT (Cognitive Behavior Therapy) produce reductions in~     PTSD and comorbid symptoms.~   "
170598|NCT01332422|"~     To investigate possible problems or questions in safety and efficacy of ADOAIR 100 DISKUS and~     ADOAIR 50 AEROSOL 120 in Japanese pediatric patients with bronchial asthma for a long term~     under the practical use conditions. In this special drug use investigation, the following~     items shall be handled as the priority investigation items for information collection.~        1. Systemic effects accompanying steroid administration; influences on adrenocortical~          function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract,~          glaucoma~        2. Events related to nervous system, musculoskeletal system and circulatory system; tremor,~          headache, cramp, tachycardia, etc.~   "
170599|NCT01332409|"~     To investigate possible problems or questions in safety and effectiveness of salmeterol and~     fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic /~     emphysema). In this special drug use investigation, onset of pneumonia shall be handled as~     the priority investigation item.~   "
170600|NCT01332396|"~     Data on the safety and efficacy of TYKERB shall be collected from the patients in order to~     grasp the actual conditions of post-marketing use and assess background information on the~     patients.~   "
170601|NCT01332383|"~     To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on~     Japanese patients with migraine headache in clinical setting~   "
170602|NCT01332370|"~     This retrospective database study analyzed resource utilization and costs associated with~     sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy~     among adults with a diagnosis of diabetes who were continuously enrolled in a large US~     healthcare plan.~   "
170603|NCT01332357|"~     The objective of this study is to compare readmission to the emergency department for asthma~     in asthma patients who receive treatment with fluticasone propionate and salmeterol oral~     inhaler after an initial emergency department visit using a retrospective observational~     cohort study design.~   "
170604|NCT01332344|"~     The objective of this study is to compare healthcare utilization and costs in asthma patients~     who receive fluticasone propionate/salmeterol combination 100mcg/50mcg (FSC 100/50) or~     inhaled corticosteriods in typical clinical practice using a retrospective observational~     cohort study design of large managed care database.~   "
170605|NCT01332331|"~     A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and~     efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in~     subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An~     additional objective is to determine the ambrisentan population pharmacokinetics in the~     paediatric population. The study will include a screening/baseline period and a treatment~     period. The treatment period will be 24 weeks or until the subject's clinical condition~     deteriorates to the point that alternative/additional treatment is necessary. Patients who~     participate in the study and in whom continued treatment with ambrisentan is desired will be~     eligible to enrol into a long term follow-up study. The primary comparison will be the safety~     and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH~     population The secondary comparison will be the change from baseline for the efficacy~     parameters between the two treatment groups.~   "
170606|NCT01332318|"~     This study was a multi center, randomized, double blind, active and placebo controlled,~     parallel group study to assess simulated driving performance in XP13512 treated subjects with~     Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose~     of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the~     placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of~     an agent known to have sedative properties, while the other 3 groups received a DPH placebo.~   "
170607|NCT01332305|"~     The objective of the study was to generate the data necessary to determine the gabapentin~     exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo,~     and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS).~   "
170608|NCT01332292|"~     This study will investigate the effect of dosing with flutucasone furoate in asthmatic~     subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over~     a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and~     serum cortisol levels.~   "
170609|NCT01332279|"~     This phase I trial studies the side effects and best dose of giving everolimus (RAD001) and~     erlotinib hydrochloride together with radiation therapy in treating patients with recurrent~     head and neck cancer previously treated with radiation therapy. RAD001 and erlotinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving RAD001 and~     erlotinib hydrochloride together with radiation therapy may kill more tumor cells.~   "
170610|NCT01332266|"~     The purpose of this study is to determine whether patients with Platinum-Resistant Squamous~     Cell Carcinoma of the Head and Neck who receive either E7050 administered with Cetuximab or~     Cetuximab alone experience greater benefit~   "
170611|NCT01332253|"~     The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will~     significantly reduce post-operative fentanyl use compared to placebo.~   "
170612|NCT01332240|"~     As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely~     spread in Belgium, the investigators aimed to determine the number of mediastinoscopies~     needed to detect one additional mediastinal lymph node invasion during routine clinical~     practice in the staging of potentially resectable clinical stage III non-small cell lung~     cancer.~   "
170613|NCT01332227|"~     The purpose of this study is to determine whether HIV-1—infected patients, who are~     virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus~     any third agent but are experiencing safety and/or tolerability issues, will maintain~     virologic suppression after switching to a regimen of heat-stable ritonavir boosted~     atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.~   "
170614|NCT01332214|"~     This is a randomised, single-blind, placebo-controlled Phase I study to investigate the~     safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to~     healthy male subjects.~   "
170615|NCT01332201|"~     Comparison of tacrolimus blood levels in adults who have received a transplant and are taking~     either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is~     followed by checking of safety and effectiveness for one year.~   "
170619|NCT01332149|"~     Pregabalin has proven effective in previous clinical trails in other countries in relieving~     neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.~      This study is being conducted according to China registration requirement to submit a~     reapplication with new local diabetic peripheral neuropathy study as a commitment plus the~     existing data to apply for Lyrica pain associated with postherpetic neuralgia indication~     after Lyrica pain associated with postherpetic neuralgia is approved.~   "
170620|NCT01332136|"~     This research study will be completed by enrolling a prospective, observational cohort study~     to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This~     investigation will compare quality of life outcomes between each treatment type, as well as~     measure cellular and molecular markers of inflammation in the sinus mucosa, to create models~     that predict improvement in quality of life following treatment.~   "
170621|NCT01332123|"~     This study is investigating the influence of several simulated real life conditions on the~     symmetry of gait with trans-tibial prostheses~      Hypotheses: It is hypothesized that the observable differences in gait pattern between~     amputees can be detected by a combination of forces and moments that are measured internally~     in the prosthesis, and electromyography data. It is further hypothesized that changing~     conditions such as uneven walking surface, prosthetic misalignment or user fatigue are~     characterized by typical values in the measured data or combinations thereof.~   "
170622|NCT01332110|"~     Patellofemoral pain syndrome (PFPS) is the most common running injury and is believed to be~     associated with higher than normal knee joint loading. Footwear has been developed that may~     decrease these knee loads in healthy subjects, but their effects on patients with PFPS are~     unknown. In this study, we aim to test the effects of such footwear on patients with PFPS. We~     hypothesize that patients who receive the footwear intervention will show a decrease in knee~     joint loading, and consequently will show improvements in subjective levels of perceived knee~     pain over a period of six weeks compared to a control condition.~   "
170623|NCT01332097|"~     This study will assess preliminary parameters of safety and efficacy of a single dose of~     BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.~   "
170624|NCT01332084|"~     The investigators plan to launch a Specific Oral Tolerance Induction (SOTI) pilot study in~     order to assess the efficacy and the safety of hypoallergenic (H.A.) wheat cereals, for~     children with allergy to wheat. The study has the potential to offer a desensitization~     treatment option for children allergic to wheat.~      The investigators hypothesize that H.A. wheat cereals have similar efficacy with less side~     effects than native wheat cereals.~   "
170625|NCT01332071|"~     The study is prospective, open-label, randomized, crossover, with 02 treatments, 02~     sequences, and 02 periods. The volunteers received, in each period, the reference or the test~     formulation after standardized meals.~   "
170626|NCT01332058|"~     The investigators are conducting a pilot study for a clinical research trial to establish the~     feasibility and acceptability of the intervention and the most effective recruitment~     strategies prior to the full study.~   "
170627|NCT01332045|"~     Our study will compare the use of continuous saphenous nerve block performed at the adductor~     canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to~     LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block~     performed at the level of the adductor canal in addition to LIA provides better pain relief~     than the LIA alone without significantly compromising muscle strength and physiotherapy,~     enabling patients to mobilize early with reduced opioid consumption and les side effects.~      The investigators will enroll a total of 40 patients (20 patients will receive continuous~     saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until~     discharge, the investigators will record patients' pain scores, opioid consumption, side~     effects and physical therapy progress.~      If our study proves that the continuous saphenous nerve block in addition to LIA can~     effectively reduce postoperative pain scores to an acceptable level with better physical~     therapy progress and less opioid consumption, it could be seen as a more attractive~     alternative to LIA alone or other traditionally used methods of postoperative pain control~     that compromises muscle strength and physiotherapy.~   "
170628|NCT01332032|"~     This randomized study compares the effectiveness and cost-effectiveness of 3 proven methods~     of reaching out to women who are coming due for or who are overdue for a mammogram. The study~     originally embedded in a community healthcare plan and an associated community clinic, now~     accepts patients using the community clinic and 3 other health care plans. The study makes~     use of a complex computer driven reminder system.~      The study also will examine ways to improve the efficiency and sequencing of the~     interventions by identifying patient factors associated with intervention effectiveness.~   "
170629|NCT01332019|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301~     (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this~     study is to describe long-term multiple sclerosis (MS) outcomes in participants originally~     treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.~   "
170640|NCT01331876|"~     Obsessive compulsive Disorder (OCD) is a frequent psychiatric disorder. Obsessions and~     compulsions are the two manifestations of this disease. Obsessions are recurrent anxious~     ideas, and compulsions repetitive behavior aiming to decrease this anxiety.~      OCD symptoms have been associated with cortical and sub-cortical dysfunctions and more~     precisely an hyperactivity of prefrontal cortex / basal ganglia loops.~      Functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex,~     anterior cingulate cortex, caudate nucleus and cerebellum activities after two OCD reference~     treatments : medication and Cognitive and Behavioral Therapy (CBT).~      Two groups of 20 patients are included in this study and follow a CBT for 15 sessions. They~     are randomised in two groups : one proposing a reference CBT, the other associate CBT to a~     new psychopedagogic task developed by the investigators team.~      Clinical investigations and neuro-imagery data are collected at the main steps of therapies :~     before, during (half-therapy), at the end of therapies and 6 month later. Symptoms severity,~     patients and relatives quality of life are also assessed.~   "
171281|NCT01323400|"~     The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with~     metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST)~     resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.~   "
170630|NCT01332006|"~     For the great majority of hematological malignancies, hemopoietic stem cell (HSC) transplant~     is the only possible cure. The source of HSC is usually bone marrow (BM) or peripheral blood~     cell (PBSC) mobilized by granulocyte growth factor. Transplant needs a HLA compatible donor~     weather related or unrelated. A suitable compatible donor can be found in at least 70% of the~     patients. Thus, at least 30% of patients with indication for allogeneic HSC transplant are~     not able to undergo the procedure because of the lack of a HLA compatible donor. Cord blood~     (CB) cells represent another possible source, that needs a lower degree of HLA compatibility.~     CB transplant, however, offers a lower number of HSC. Thus, adult patient rarely may benefit~     from this source of stem cells, mainly beacuse thie body weight is too high to have ad~     adequate number of cell per kg. Recently, experimental animal models confirmed that an~     adequate recovery of allogeneic hemopoiesis can be achieved via intrabone injection, using a~     1Log lower number of cells compared to the intravenous way (Yahata 2003, Castello 2004).~     Safety and feasibility of intrabone infusion was verified by two clinical studies on humans:~     the first was conducted by Ringden O. et al. in 18 patients using BM as a source of SC. No~     side effects and complete engraftment of donor hemopoiesis was observed; the second one was~     conducted by Frassoni et al. (Frassoni 2008) with CB as the source of HSC.~      The aim of this study is to evaluate the intrabone infusion of compatible CB in patients with~     haematological malignancies lacking a HLA matched donor.~      We will perform:~      evaluation of the engraftment kinetics; evaluation of the chimerism degree at 30, 60, 100~     days, 6 months and 1 year after transplant; studies on immunological reconstitution and the~     role of the NK compartment.~   "
170631|NCT01331993|"~     The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO~     manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as~     VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen~     formulation.~   "
170632|NCT01331980|"~     Cystic fibrosis (CF) affects an estimated 30,000 people in the United States and is caused by~     a mutation in the gene encoding a protein called CF transmembrane regulator (CFTR). The~     hallmarks of CF are recurrent pulmonary exacerbations and declining pulmonary function.~     However, there are other problems in CF that affect both health and quality of life. These~     include CF related diabetes, liver disease, and bone disease. The median age of survival for~     patients with CF has been increasing steadily and is currently more than 37 years. With this~     improvement in life expectancy, it has become increasingly important to address the long-term~     complications of CF.~      Currently, patients with CF are evaluated annually for bone disease with dual X-ray~     absorptiometry (DXA), and screening usually starts at age 12. However, this may not be~     sufficient to detect early bone changes that may impact fracture risk. Furthermore, bone~     disease in children may manifest earlier than adolescence, which would suggest that screening~     should start at an earlier age in these vulnerable patients. The following study is therefore~     proposed to examine the potential role of peripheral quantitative computed tomography (pQCT)~     as a screening approach for bone disease in children with CF. The investigators expect to~     find bone problems by pQCT but not DXA.~   "
170633|NCT01331967|"~     Pioglitazone is used in the treatment of diabetic patients. Thiazolidinediones increase~     insulin sensitivity and show favorable effect on blood glucose levels and lipid profiles. The~     effect of pioglitazone on atherosclerotic and inflammatory markers has not been compared in~     prospective manner after everolimus-eluting stent implantation by OCT. The purpose of this~     prospective, randomized, open-label trial is to compare the effect of pioglitazone on~     neointima volume and atherosclerosis progression in type 2 diabetic patients by using OCT.~     Moreover, changes in neointima characteristics could be analyzed along with the changes in~     miRNA-21, -126, -143, -145. Major adverse cardiovascular events such as non-fatal MI, death,~     stroke, and TLR could be compared.~   "
170634|NCT01331954|"~     Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast~     fibroadenoma.~   "
170635|NCT01331941|"~     This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced~     solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of~     renal dysfunction) will receive weekly doses of AMG 386 intravenously. The primary objective~     is to evaluate the pharmacokinetics (PK) of single agent AMG 386 in subjects with various~     degrees of renal function. Once the AMG 386 PK characterization is complete in the first 5~     weeks of the study, all subjects will be allowed to continue to receive AMG 386 weekly only~     or subjects in group 1, 2 or 3 can opt to receive AMG 386 weekly in combination with~     paclitaxel until disease progression, unacceptable toxicity or withdrawal of consent.~   "
170636|NCT01331928|"~     The purpose of this study is to determine whether sequential chemotherapy with capecitabine~     plus oxaliplatin (Xelox) followed by docetaxel plus capecitabine (TX)in unresectable gastric~     cancer.~   "
170637|NCT01331915|"~     In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin~     coupled to melanoma antigen) some patients with advanced metastatic melanoma disease.~      The primary objective is to analyze the safety of the inreasing doses of vaccine.~      The secondary objective is to document whether this vaccine can induce tumor regression in~     immunized patients.~   "
170638|NCT01331902|"~     The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of~     maximal coronary hyperemia compared with adenosine.~   "
170639|NCT01331889|"~     Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However,~     potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in~     the reservoir of rapid infusion system and its effect on the plasma potassium change during~     rapid transfusion are unknown. This study is designed to investigate these changes while~     massive transfusion is performed during liver transplantation surgery.~   "
170641|NCT01331863|"~     -  First study (BRONC-ART) The purpose of this prospective study is to evaluate the 90-day~          morbidity and mortality rates of bronchial transplantation using cryopreserved aortic~          allograft in proximal lung cancer surgery. The investigators hypothesize that this stage~          1-2 surgical innovation could be safe and effective in order to reduce the 90-day~          morbidity and mortality rates compared to those observed with pneumonectomy, especially~          when some factors are present: age > 70 years, right side, neoadjuvant~          chemoradiotherapy.~        -  Current study (TRACHEO BRONC-ART) The BRONC-ART study was extended to major (malignant~          or benign) lesions of the trachea requiring airway transplantation.~      For these patients, resection followed by direct end to end anastomosis is not possible or at~     high risk.~   "
170642|NCT01331850|"~     This randomized, open-label, multi-center study will evaluate the sustained virological~     response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with~     Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection.~     Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will~     be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to~     Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir~     100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg~     twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive~     Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day~     for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180~     microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.~     In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus~     treatment.~   "
170643|NCT01331837|"~     This randomized, open-label, parallel-group, multicenter study will evaluate the rate of~     cardiovascular events with tocilizumab in comparison to etanercept in participants with~     rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8~     milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg)~     etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug~     (DMARD).~   "
170644|NCT01331824|"~     The primary objective of this study is to determine in subjects with metastatic measurable~     bladder cancer (or urothelial cancers originating elsewhere in the genitourinary tract) who~     have progressed on 1 prior chemotherapeutic regimen the objective response rate to treatment~     with amrubicin. The secondary objectives will be to evaluate progression-free survival,~     survival at 1 year, and the safety of amrubicin as second-line therapy in patients with~     metastatic urothelial carcinoma.~   "
170645|NCT01331811|"~     Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the~     difficulty of its diagnosis is increased in case of HIV infection in children.~      The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new~     diagnostic algorithm incorporating new tools available such as:~        -  interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test~        -  alternative specimen collection methods such as string test (or Enterotest (R)),~          nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate~        -  the Xpert MTB/RIF assay~   "
170646|NCT01331798|"~     A blinded, prospective, randomized trial in 40 abdominoplasty cases at three sites to study~     the safety and the preliminary efficacy of TissuGlu®, a novel surgical adhesive, in the~     management of wound drainage during abdominoplasty procedures.~   "
170647|NCT01331785|"~     Ascites is a frequent complication of patients with portal hypertension. As portal~     hypertension progresses, a percentage of these patients develop refractory ascites.~     Management options at that point include either TIPS or intermittent large volume~     paracentesis (LVP), with its attendant risks, Portal hypertension is accompanied by systemic~     circulatory dysfunction (decreased systemic vascular resistance and systolic BP), which is~     exacerbated by large volume paracentesis, with resultant renal and cardiac dysfunction. There~     are limited options for managing patients with acute decompensation, such as hepatorenal~     syndrome, although midodrine and other vasoconstrictors have been used in such patients.~     Midodrine has not been used as a possible therapeutic for ascites. Midodrine however, has~     been found to change the hemodynamics related to portal hypertension and ascites. There has~     been also change in mediators related to renal and circulation in studies of short duration~     (7 days) but not found in studies of 1 month duration, however the clinical effects of~     midodrine is found for longer duration in other similar conditions.~      The purpose of the study is to assess the utility of midodrine in patients with obvious~     systemic circulatory dysfunction (hypotension) in improving the outcome of patients with~     refractory ascites and change in hemodynamic parameters and its mediators.~      Specific endpoints include:~      1) an objective reduction of the volume/rate of accumulation of ascites and 2) a decrease in~     the frequency of LVP.~   "
170648|NCT01331772|"~     Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or~     obesity, physical inactivity and alcohol consumption are risk factors commonly associated~     with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced~     physical activity is one factor likely to weight gain in women after adjuvant chemotherapy~     for localized breast cancer. Furthermore, physical activity appropriately could improve many~     prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA)~     could improve fitness, quality of life, body image, treatment compliance and reduce fatigue.~      After diagnosis of breast cancer, there is many possible risk factors of mortality or~     morbidity related to nutritional factors available to management. These risks prevention~     through management of these patients appears indispensable through an APA program.~      Thus, the investigators propose to test the feasibility of implementing a program of dietary~     intervention and APA to prevent the risk of weight gain (which affects more than half of~     patients) and maintain and/or increase their level of physical activity during and after~     adjuvant chemotherapy.~   "
170649|NCT01331759|"~     Neuropattern™, a new diagnostic tool for stress related disorders is being applied in a~     demanding workplace environment. Neuropattern™ aims at identifying stress-related bodily~     changes at an early stage. By identifying subgroups based on Neuropattern™ subjects gain~     access to online counseling specified according to their Neuropattern™ diagnosis. Efficacy is~     being assessed by several questionnaires in a follow-up.~   "
170650|NCT01331746|"~     A study to look at the effectiveness of a drug called APD515, designed to be applied to the~     lining inside the mouth, at relieving dryness of the mouth. Study will compare one week of~     treatment with APD515 to one week of treatment with matching placebo to see which has better~     effect on patient's mouth dryness, according to their own score.~   "
170651|NCT01331733|"~     To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary~     gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in~     females undergoing intrauterine insemination.~      Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more~     effective than monotherapy.~   "
171291|NCT01323270|"~     This study is to look at a new vaccine that might prevent meningococcal disease, and to look~     at the safety of the new vaccine as well as how it is tolerated when given together with~     Repevax. The study will be done in healthy adolescents.~   "
170652|NCT01331720|"~     The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian~     hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females~     undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro~     fertilisation/intracytoplasmic sperm injection).~      Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary~     hMG (human menopausal gonadotropin)should be more effective than monotherapy.~   "
170653|NCT01331707|"~     The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has~     led to a significant reduction in morbidity but there are further demands on DES performance.~     Such demands are an optimized performance in very challenging coronary lesions; third~     generation DES were developed in an effort to further improve DES performance in such~     challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus~     Element stents) are currently available; there are no data that indicate an advantage of one~     of these DES over the other.~   "
170654|NCT01331694|"~     To evaluate COPD-related clinical outcomes and total healthcare utilization in commercially~     insured (at least 40 years with a subanalysis of those aged 65 years and older) COPD~     population associated with the use of fluticasone/salmeterol combination (FSC) 250/50mcg~     compared to other initial maintenance therapies (IMTs), specifically, tiotropium bromide~     (TIO), and either ipratropium bromide or ipratropium bromide/albuterol (IP).~      This is a hypothesis testing study~      Ho: There is no difference in time to first COPD-related events between FSC and TIO and FSC~     and IP Ha: There is a difference in time to first COPD-related events between FSC and TIO and~     FSC and IP~      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:~      Ho: There is no difference in COPD-related costs between FSC and TIO and FSC and IP Ha: There~     is a difference in COPD-related costs between FSC and TIO and FSC and IP~   "
170655|NCT01331681|"~     To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the~     best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy~     study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement~   "
170656|NCT01331668|"~     This study aims to maintain a prospective biobank of human samples obtained from donors and~     recipients of renal allografts, including biopsy tissue, peripheral blood samples and urine~     samples.~   "
170657|NCT01331655|"~     The objective of this three-arm study is to evaluate the effect of a flexible extended~     regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance~     with daily pill intake when the investigational product is provided in a blister package or a~     compliance aiding dispenser with a pill reminder function. The third treatment arm will be a~     reference comparator arm of a standard 24+4 regimen of the identical hormone combination.~   "
170658|NCT01331642|"~     Gaucher disease is an autosomal recessive hereditary lysosomal storage disorder. Occurrence~     of the disease is due to a hereditary deficiency of the Glucocerebrosidase, a lysosomal~     enzyme which divides Glucocerebroside in to Glucose and Ceramides.~   "
170659|NCT01331629|"~     The purpose of this study is to compare intervention by Art-therapy to standard care in~     patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue.~   "
170660|NCT01331616|"~     Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy~     lead to optic neuropathy?~   "
170661|NCT01331603|"~     Recently, it has been demonstrated that iron overload is associated with the appearance of~     labile plasma iron (LPI).~      LPI is redox active and is rapidly taken up by cells, leading to a rise in the labile iron~     pool (LIP) and catalyzing generation of reactive oxygen species (ROS), which can lead to~     cellular damage.~      The LPI data are mostly derived from thalassemia iron overload research , however, there are~     a few data describing LPI and its correlations with the classical iron overload parameters~     (ferritin, TSAT) in acute anemias such as MDS Therefore we are going to assess LPI in iron~     overloaded myelodysplastic syndromes (MDS) (low and high risk) and primary myelofibrosis, in~     order to assess whether it can be used as alternative to the routinely used parameters; TSAT~     and ferritin levels.~   "
170662|NCT01331590|"~     The purpose of this study is to determine the ability of G-CSF to disrupt the bone marrow~     microenvironment as a means to increase the efficacy of chemotherapy in patients with~     relapsed or refractory acute lymphoblastic leukemia (ALL).~   "
170663|NCT01331577|"~     Stress is a common problem with significant consequences for health. It can be a trigger for~     somatic diseases as well as psychological disorders and leads through missed working days and~     healthcare cost to a high economic loss. It is for health and economic reasons essential to~     develop and evaluate effective interventions that can inoculate against stress and build~     inner strength.~      A cognitive-behavioural training for groups that is well evaluated and has shown to be~     effective is the Stress-Inoculation-Training by Meichenbaum. As the public utilization of~     methods of the complementary and alternative medicine is increasing a rigorous evaluation is~     needed. Integrative Kinesiology is a popular method that has been said to be effective~     against stress and its symptoms.~      The investigators propose a randomized controlled evaluation and comparison of the~     interventions to each other and to a waiting-list control group. Hypothesis: Healthy~     volunteers attending a two dayseminar will show significantly reduced psychobiological~     reactivity, decreased stress perception and less anxiety to a standardized psychosocial~     stress test compared to the waiting list group. A total of 64 healthy volunteers will be~     randomly assigned to one of the three groups. The efficacy of the interventions will be~     measured through the Trier Social Stress Test (TSST) to measure the psychobiological stress~     reactivity.~   "
170664|NCT01331564|"~     The project aims to develop, implement and evaluate electronically-mediated behavioral~     intervention programs for pregnant and postpartum women in order to prevent excessive weight~     gain during pregnancy and postpartum weight retention.~   "
170665|NCT01331551|"~     The purpose of this study is to investigate the relationship of high exposure to dibutyl~     phthalate (DBP) from the use of Asacol with clinical and intermediate markers of male~     fertility, including semen quality, sperm DNA damage, transcript profiles of sperm mRNA and~     sncRNAs, and reproductive hormones.~      Hypothesis 1: High exposure to DBP from the use of Asacol is associated with decreased sperm~     concentration and motility, and increased sperm DNA damage.~      Hypothesis 2: High exposure to DBP from the use of Asacol is associated with decreased serum~     testosterone, altered LH:testosterone ratio, and decreased inhibin-B.~      Hypothesis 3: High exposure to DBP from the use of Asacol is associated with altered~     transcript profiles of sperm mRNAs and sncRNAs.~   "
170666|NCT01331538|"~     The aim of this research was to determine the existence of a correlation between the degree~     of temporomandibular dysfunction and cervical posture in different occlusal classes in~     adolescents. A cross-section, observational study was carried out, in which 296 adolescents~     took part. For the evaluation, the patients were divided into groups according to the~     presence and severity of the temporomandibular dysfunction, using a questionnaire and~     occlusal Angle classification. The posture analysis was carried out using photogrammetry and~     the software Alcimage® to measure the predefined angle based on the protuberances of the~     Spinous Process of the 7th Cervical Vertebra (C7), Manubrium of the sternum and Mentum~     Vertex.~   "
170667|NCT01331525|"~     This trial will investigate the addition of an antibody (Ipilimumab) to conventional~     Carboplatin and Etoposide chemotherapy in extensive stage small cell lung cancer.~      The primary objective is to establish the progression free survival at 1 year.~   "
170668|NCT01331512|"~     Background:~      - Older persons are often referred to physicians because of mobility difficulties that grow~     worse as they age. To better understand the reasons for mobility difficulties in older~     persons, researchers conducted a population-based study of individuals living in the Chianti~     geographic area of Tuscany, Italy. Researchers are now interested in conducting a follow-up~     study on the original participants to assess the effects of aging on their mobility.~      Objectives:~      - To conduct a follow-up study on the participants in the mobility study of older persons in~     the Greve in Chianti and Bagno a Ripoli areas near Florence, Italy.~      Eligibility:~      - Original participants in the InChianti Mobility Study.~      Design:~        -  The InChianti Follow-up Study will repeat most elements of the baseline evaluation from~          the original study. Participants will be seen on the 3-year anniversary of their~          baseline study assessment.~        -  Participants will have a home interview with questions about their physical and mental~          health, family history, daily activities, and living conditions related to their~          continued mobility.~        -  Participants will provide blood and urine samples, and will have tests of heart and~          motor nerve function and imaging studies of bones and the circulatory system.~        -  Participants will also have a functional evaluation of their motor skills, including~          walking tests, range of motion tests, and grip strength.~   "
170669|NCT01331499|"~     The purpose of this study is to compare standard of care hemostasis techniques with and~     without the use of Aquamantys in reducing peri-operative blood loss.~   "
170670|NCT01331486|"~     Prehypertension and mild hypertension affect an estimated 157 million U.S. adults.~     Cardiovascular disease (CVD) risk and associated mortality is elevated in this population.~     Treatment options are limited consisting of lifestyle modification, which is often~     ineffective, or drug therapy, which carries risk of side effects. Highly safe, efficacious,~     and acceptable treatment options for this population are needed. Hawthorn standardized~     extract (HSE) is approved for use in Europe to treat heart failure, and preliminary evidence~     suggests it may have a blood pressure lowering effect. However, prior trials of hawthorn have~     based dosage recommendations on animal studies. Therefore, the investigators propose a~     dose-finding study to measure the pharmacodynamic effect of three doses of standardized~     hawthorn extract and placebo.~   "
170671|NCT01331473|"~     To compare the incidence of new ischemic brain injury detected with magnetic resonance~     imaging (MRI) after carotid artery stenting in patients treated with and without proximal~     cerebral protection (Gore Flow Reversal System).~   "
170672|NCT01331460|"~     The purpose of this study is to determine how drug abuse treatment interventions can be~     integrated with established Human Immunodeficiency Virus prevention approaches to optimize~     their combined effectiveness.~   "
170673|NCT01331447|"~     The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under~     fasted conditions~   "
170674|NCT01331434|"~     The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under~     fed conditions.~   "
170675|NCT01331421|"~     The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under~     fasted conditions~   "
170676|NCT01331408|"~     The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume~     restoration and shaping of the buttocks.~   "
170677|NCT01331395|"~     The purpose of this study is to determine the value of combining Traditional Chinese Medicine~     (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).~   "
170678|NCT01331382|"~     Resveratrol is associated with a plethora of physiological effects in humans, including~     modulation of cerebral blood flow, despite apparently poor bioavailability. This study~     investigated whether the physiological effects of resveratrol could be affected when~     co-supplemented with piperine, an alkaloid which may be able to enhance the bioavailability~     of resveratrol.~   "
170679|NCT01331369|"~     The aim of the study is to evaluate the effectiveness of a social-psychological intervention~     to improve anti-hypertensives adherence in primary care. Its is a pragmatic clinical trial.~   "
170680|NCT01331356|"~     The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in~     refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in~     the ganglion Impar (total dose = 100 units)~   "
170681|NCT01331343|"~     The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian~     RT glucose sensor can improve glycemic control over a 12-week period, compared to patients~     using self-monitoring blood glucose testing (SMBG) alone.~   "
170682|NCT01331330|"~     To evaluate the effects of two different programming settings of deep brain stimulation (DBS)~     in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for TR-MDD,~     single or recurrent episode on mood as measured by the MADRS.~   "
170683|NCT01331317|"~     The primary objective is to assess the impact of three months of treatment with an active~     vitamin D analogue on a risk marker for excess overall mortality and cardiovascular~     morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. The hypothesis~     is that active vitamin D analogue treatment reduces the risk of cardiovascular morbidity and~     mortality in patients with type 1 diabetic kidney disease.~   "
170684|NCT01331304|"~     The purpose of this study is to compare the effectiveness of lithium and quetiapine for the~     treatment of individuals with bipolar disorder.~   "
171315|NCT01322958|"~     Observational study of the use of ultrasound by emergency physicians in the evaluation of~     patients at risk of ectopic pregnancy.~   "
170685|NCT01331291|"~     For many brain tumors, one reason that chemotherapy drugs might not be effective is that the~     drug may not be able to get into the brain tumor and kill the cancer cells. The brain is~     protected by a layer called the blood brain barrier. This barrier prevents substances from~     entering. The purpose of this research study is to determine if bosutinib can get past the~     blood brain barrier and into the brain tumor, and to see how well bosutinib works in killing~     cancer cells.~   "
170686|NCT01331278|"~     The custom cutting guides personalized for each patient via pre-operative MRI will result in~     significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee~     function, and patient satisfaction.~   "
170687|NCT01331265|"~     The goal of this study was to examine the effects of self-perceived lactose intolerance~     (SPLI) as it relates to calcium intake and specific health problems that have been attributed~     to reduced intake of calcium and foods from the dairy group in a nationally representative~     multi-ethnic sample of adults.~   "
170688|NCT01331252|"~     This is a randomised controlled trial of the incidence of nosocomial pneumonia in patients~     with severe tetanus admitted to the intensive care ward nursed in a supine or semi-recumbent~     position.~   "
170689|NCT01331239|"~     This exploratory study is a proof of concept study to determine whether LCI699 can safely~     reduce the level of urinary free cortisol in patients with Cushing's disease. In addition,~     this study will evaluate the long term efficacy and safety of LCI699 including an additional~     12 week of treatment followed by a 12 month long term optional extension. A second extension~     will provide patients who are clinically benefitting from LCI699 an opportunity to continue~     to have access to the drug until LCI699 is commercially available and reimbursed or through~     the availability of a local access program.~   "
170690|NCT01331226|"~     This study is designed to examine if a telephone-based intervention delivered to a support~     person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota~     helpline. In addition, the study will examine if the rate of smoker calls to the helpline is~     greater if the support person receives 3 intervention calls, 1 intervention call, or no calls~     (written materials only, control condition).~   "
170691|NCT01331213|"~     The general aim of the current study is to describe the effect of pregabalin on colonic and~     sensory functions in adults with constipation predominant irritable bowel syndrome (IBS-C).~      Study hypotheses:~        1. Single-dose pregabalin 200mg increases sensation thresholds and decreases sensation~          ratings in response to balloon distension in the colon relative to pre-pregabalin~          treatment.~        2. Single-dose pregabalin 200 mg will increase colonic compliance and decrease colonic pain~          and gas thresholds in patients with irritable bowel syndrome constipation predominant.~        3. Single-dose pregabalin 200mg increases the colonic phasic and tonic response to a~          standardized meal.~   "
170692|NCT01331200|"~     The purpose of this study is to study the safety and feasibility of mobilization of acute~     ischemic stroke patients treated with IV-tPA between 12-24 hours of treatment.~   "
170693|NCT01331187|"~     Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical~     department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia,~     hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall~     bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic~     tool in these diagnosis, and on early diagnosis is crucial with respect to the patients~     well-being and inpatients workflow.~      1. The aim is to study the clinical use of pocket-size US as a screening diagnostic tool in~     an medical department with respect to inpatients workflow and diagnostics.~      Method: Patients admitted (in certain preset periods) to Department of medicine will be~     randomized to routinely adding an ultrasound examination with pocket-size device by residents~     on call. Time to definitive diagnosis, time to definitive treatment and time to discard will~     be recorded. US findings will be validated against standard echocardiography, or standard~     US/CT/MRI performed at the Radiological department.~   "
170694|NCT01331174|"~     Study design: Randomized clinical trial. Objective: To evaluate the effect of PSW treatment~     in different doses and to compare to the control and placebo group.~      Background: Several forms of conservative treatment have been the focus of many recent~     studies in knee osteoarthritis (OA). Among these techniques, the application of pulsed short~     wave has been widely used, but the optimal dose and application time still have not been well~     established.~   "
170695|NCT01331161|"~     Vaccination is the most effective way of preventing infectious diseases. Despite the success~     of vaccines in general, vaccines induce diminished antibody responses and lower protection in~     the elderly in particular. This could be explained by a defect in the early responses of an~     ageing immune system. A better understanding of the basic immunological mechanisms that~     mediate vaccine efficacy is incomplete. Such information is critical and could greatly~     decrease both the cost and the time to new vaccine development particularly for the geriatric~     population.~      In this trial, the investigators will study the immunologic differences of the FDA approved~     licensed shingles vaccine between a younger and an older group. Thirty three healthy~     volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of~     60-79 will be enrolled in the study. Each participant in the study will be given one shingles~     shot. Blood work will be obtained one month before vaccination, on the day of vaccination,~     one day, three days, seven days, fourteen days, one month, three months and six months after~     vaccination. Throughout the duration of the study, the participants will be monitored for~     safety.~   "
170704|NCT01331044|"~     1. RUTF would be more effective (quicker catch-up growth by promoting more tissue accrue~          resulting decrease stay in rehabilitation ward) in treating children with SAM during the~          rehabilitation phase than khichuri /halwa;~        2. RUTF would be acceptable to the children and their mothers/caregivers;~        3. Malnutrition is not caused solely by lack of food, but also by impaired utilization of~          the food that is ingested. The ability of the gut to absorb nutrients from the diet is~          associated with the host's 'human' genotype, the host's gut microbiota and its gene~          content (the microbiome).~   "
170705|NCT01331031|"~     The disorders that affect the temporomandibular joint (TMJ) are responsible for the diverse~     symptoms. Objective: To evaluate whether or not the relationship between signs or symptoms of~     TMD and presence of harmful habits. The investigators evaluated 244 adolescents enrolled in~     public school . The investigators used the questionnaire for selection of orofacial pain and~     temporomandibular disorders, recommended by American Academy of Orofacial Pain to assess the~     presence or absence of signs and symptoms of TMD.~   "
170696|NCT01331148|"~     Vitamin D deficiency (VDD) is very common among African American adolescents and adults in~     the US, ten times higher than is seen in Caucasians. VDD is also quite common in sickle cell~     disease (SCD). Both VDD and SCD can cause chronic pain, compression fractures, and muscle~     weakness. The investigators believe VDD may contribute to poor musculoskeletal health and~     chronic pain seen in pediatric SCD. In this study, the investigators aim to show that~     children and adolescents with SCD and chronic pain have lower levels of vitamin D compared to~     those without chronic pain. The investigators also aim to determine the clinical~     characteristics in SCD patients related to their vitamin D status.~      About 60 subjects (7 to 21 years old) will be enrolled on this study, 30 with chronic pain~     and 30 without chronic pain. The investigators will assess baseline characteristics including~     vitamin D levels, bone turnover rates (measured by C telopeptide blood levels [CTx]), markers~     of inflammation and oxidative stress levels in blood, baseline hemoglobin and other~     laboratory parameters, presence of abnormal bones on chest x-ray, pulmonary function, opioid~     analgesic use, overall muscle strength, quality of life and depression.~      To evaluate the impact of vitamin D replacement on these baseline characteristics, the~     investigators will randomize subjects to receive either placebo or high dose vitamin D for 6~     weeks after which time the investigators will evaluate overall vitamin D status, muscle and~     bone health, depression, quality of life, pain status and use of opioid pain medications,~     inflammation and oxidative status comparing before and after treatment with high dose vitamin~     D. The investigators will give—at no cost to subjects—a daily supplement that will provide~     the recommended daily allowance of calcium and vitamin D that contains 500mg Calcium and~     200IU vitamin D to subjects throughout the study period. Subjects will be in the study for 7~     months and have five to six study visits.~   "
170697|NCT01331135|"~     The best treatment for recurrent cancers or those that do not respond to therapies is not~     known. Typically, patients with these cancers receive a combination of cancer drugs~     (chemotherapy), surgery, or radiation therapy. These treatments can prolong their life but~     may not offer a long-term cure.~      This study proposes using a drug called Sirolimus in combination with common chemotherapy~     drugs to treat patients with recurrent and refractory solid tumors. Sirolimus has been found~     to inhibit cell growth and to have anti-tumor activity in pediatric solid tumors in previous~     studies and, therefore, has the potential to increase the effectiveness of the chemotherapy~     drugs when given together.~      This study wil investigate the highest dose of Sirolimus that can be given orally with other~     oral chemotherapy drugs. Cohorts of 2 subjects will be started at the minimum dose. The dose~     will be increased in the next 2 subjects as long as there were no major reactions in the~     previous groups. This study will also seek to learn more about the side effects of sirolimus~     when used in this combination and what effects the drug has on the white cells and the immune~     system. Successful use of this drug will impact the cancer population greatly by providing an~     increased chance of survival to those with resistant or recurrent cancers.~   "
170698|NCT01331122|"~     Freezing of Gait (FoG) is a class of symptoms that occur in Parkinson's patients. Also called~     motor blocks, FoG is characterized by a sudden inability to move the lower extremities which~     usually lasts less than 10 seconds. The exact pathophysiology of FoG is poorly understood,~     but treatment with levodopa appears to improve FoG observed in the off-state. As Parkinson's~     patients progress in severity, FoG in the on-state can increase in frequency and appears to~     be resistant to dopaminergic therapies. There is additional evidence that norepinephrine as~     well as dopaminergic systems may be involved in FoG.~      Droxidopa has has been approved for use in Japan since 1989 for treatment of frozen gait or~     dizziness associated with Parkinson's Disease. This study is to further explore the safety~     and efficacy of droxidopa in this indication.~   "
170699|NCT01331109|"~     The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in~     pediatric patients aged 13 to 17 years with primary fibromyalgia.~   "
170700|NCT01331096|"~     Patients in Pisa will undergo thyroid gland surgery. In the protocol group anesthesia will be~     performed using an automated anesthesia delivery system; preoperative and intra-operative~     assessment of patients will be performed via video-conferencing from Montreal, which will~     also monitor and control anesthesia delivery via distant Internet connection - as supervision~     of functioning of the automated anesthesia delivery system. In the control group anesthesia~     will be performed in a standard fashion with manual control of the syringe pumps infusing~     anesthetics drugs.~      The hypothesis is that Tele-anesthesia, considered as preoperative assessment and anesthetic~     control of an automated anesthesia delivery system is feasible and reliable via standard~     means of internet communication (distant control via virtual network) and performed as well~     or even better than manual control of the anesthetic drugs infusion.~   "
170701|NCT01331083|"~     The purpose of this study is to find out whether the new drug PX-866 will slow the growth of~     your prostate cancer. The investigators will also watch you carefully for any side effects~     that PX-866 might cause.~   "
170702|NCT01331070|"~     Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non~     reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking,~     which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the~     sixth leading cause of death in 1990. It is projected to be the fourth leading cause of death~     worldwide by 2030 due to an increase in smoking rates and demographic changes in many~     countries. COPD is responsible for 16000 deaths per year in France, 100 000 hospitalizations~     per year and the health care expenditure of COPD in France is 3.5 billion of Euros. Classical~     markers of the disease severity, the forced expiratory volume in one second, poorly~     correlates with dyspnea and prognosis. Therefore, many studies focused on the control of~     breathing in an attempt to understand the pathophysiological mechanisms involved in the~     progression of the disease. Breathing control is enhanced in patients with COPD due to the~     progressive failure of respiratory muscles (airflow obstruction, static and dynamic~     hyperinflation, positive intrinsic end expiratory pressure), the ventilation/ perfusion ratio~     abnormalities leading to the loss of the gaz exchange efficiency. Inspiratory command depends~     on the medulla automatic pathway and the voluntary corticospinal command. Indirect method of~     breathing control estimation suggested in COPD patients an increased excitability of neurons~     involved in the voluntary diaphragm activation and a reduced cortical reserve. This may~     represent an increase risk factor for acute respiratory failure. Until now, no study reported~     the central breathing control with cerebral fMRI in COPD patients.~   "
170703|NCT01331057|"~     The primary purpose is the validation of an instrument of the first language assessment. The~     second purpose is to study the impact of familial and transcultural factors on early~     bilingualism in migrant children born in France.~   "
170706|NCT01331018|"~     This pilot clinical trial will access the toxicity and efficacy of infusion of gene modified~     cells for patients with Fanconi anemia (FA). Infusion of autologous patient blood stem cells~     that have been corrected in the laboratory by introduction of the normal gene may improve~     blood counts in patients with FA.~   "
170707|NCT01331005|"~     This study is being conducted to assess the effects of topical nonsteroidal~     anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with~     non-central diabetic macular edema (DME). A secondary objective of this study is to assess~     the effects of topical NSAIDs on central subfield thickness and to compare the progression of~     non-central DME to central DME as determined by optical coherence tomography (OCT) and~     stereoscopic fundus photographs. Furthermore, this phase II study is being conducted (1) to~     determine whether the conduct of a phase III trial has merit based on an anatomic outcome,~     (2) to estimate recruitment potential of a phase III investigation, and (3) to provide~     information on outcome measures needed to design a phase III trial. The study is not designed~     to establish the efficacy of NSAIDs in the treatment of non- central DME.~   "
170708|NCT01330992|"~     The mammalian eye serves both visual and non-image-forming functions. New information about~     the non-image-forming anatomy and physiology of the eye has revealed effects of ocular light~     stimuli on human circadian rhythms, melatonin suppression, heart rate, pupillary reflexes,~     cognitive performance, alertness and sleep. The results of the proposed work can be used to~     make predictions about the effects of light, to make recommendations involving exposure to or~     avoidance of light, and to design environmental lighting, resulting in improved health and~     alertness and decreased errors and accidents.~   "
170709|NCT01330979|"~     An open-label, non-comparative, pilot evaluation of the 24-hour ocular hypotensive efficacy~     of AR-12286 in patients with open-angle glaucoma or ocular hypertension~   "
170710|NCT01330966|"~     The purpose of this study is to determine the effectiveness and safety of single agent~     pazopanib in subjects with chondrosarcoma.~   "
170711|NCT01330953|"~     The purposes of this study are (1) To determine the safety of LY2928057 in healthy people,~     and any side effects that might be associated with it; (2) To understand how the body of~     healthy people handles LY2928057; (3) To determine the effect of LY2928057 on blood iron~     level in people's body; and (4) To evaluate how people's immune system reacts to LY2928057.~   "
170712|NCT01330940|"~     Beverages containing citrate may be useful in increasing urine citrate content and urine pH.~     Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more~     citrate than other similar beverages. The investigators are interested in whether diet soda~     will improve urine chemistry in the appropriate manner.~   "
170713|NCT01330927|"~     The purpose of this study is to establish the dose response relationship of VA106483 and~     nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic~     Hypertrophy (BPH) who are likely to present with nocturia.~   "
170714|NCT01330914|"~     Obesity is a chronic illness of staggering proportions. Because weight loss through diet and~     exercise is difficult to attain and maintain, there has been escalating interest in bariatric~     surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in long-term~     weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality.~     Emerging evidence suggests, however, that gastric bypass may have negative effects on bone~     health. Because of the serious consequences of osteoporosis and fracture, this is of great~     concern. This study of the effects of gastric bypass on calcium metabolism and the skeleton~     may positively impact the clinical care of gastric bypass patients by their surgeons, primary~     care providers, and endocrinologists. Further, the knowledge gained may inform future~     investigation into the relationships between obesity, weight loss, and bone biology.~   "
170715|NCT01330901|"~     This study is aimed at investigation of efficacy and safety of ustekinumab (monoclonal~     antibody against interleukin 12 and 23) treatment in patients with active ankylosing~     spondylitis (AS) fulfilling the modified New York criteria who have had an inadequate~     response to standard therapy with non-steroidal anti-inflammatory drugs (NSAIDs) or do not~     tolerate or have a contraindication for NSAIDs.~   "
170716|NCT01330888|"~     The purpose of this 2-year pilot study is to explore the impact of deployment on the~     psychosocial and health characteristics and reintegration of Military Chaplains, specifically~     those of the Army National Guard (ARNG). This pilot will serve as the foundation for~     subsequent investigations of chaplains from multiple branches of the military. In addition to~     spiritual and religious support, Military Chaplains play a key role in the behavioral health~     of deployed service-members, routinely participating in suicide prevention training,~     conducting critical event debriefing, and identifying service-members at risk for combat and~     operational stress reactions1. A high risk group for exposure to trauma2, Military Chaplains~     have suffered brain injuries, gunshot wounds and blast injuries in OEF/OIF Theater3. In~     addition, many report combat related stress issues such as compassion fatigue, PTSD, and~     reintegration issues3. While the traumatic experiences of OEF/OIF deployed troops have been~     well documented, the effects on military chaplains caring for these service-members have~     received little attention in the research to date. We are collaborating with the National~     Guard Chaplain Corps Leadership on this program of research. The aims of this 2-year pilot~     cross-sectional study focus on describing and exploring deployment and its impact on~     psychosocial, health characteristics and reintegration of ARNG chaplains using a mixed method~     approach (web-based survey, in-depth interviews, social network analysis).~   "
170717|NCT01330875|"~     Questionnaire for patients who got a lumbar infiltration in our clinic. The patients will~     have to answer questions concerning their pain. (The lumbar infiltration itself is not part~     of this study)~   "
170718|NCT01330862|"~     The study is to provide accurate, reliable information on NSCLC clinical management across~     MENA (Middle East North Africa) countries in order to detect unmet medical needs of this~     disease, it is a purely observational study; therefore patients are not assigned to a~     particular therapeutic strategy beforehand by a protocol. Treatment will be according to~     current clinical practice.~   "
170719|NCT01330849|"~     The purpose of this study is to examine the efficacy of the ADHD-Toolkit (a toolkit for~     school behaviour modification in primary school children with ADHD-behaviours) in terms of~     general improvement in ADHD symptoms, specific targeted school-related problem behaviours,~     other disruptive behaviour disorder symptoms, teacher attitudes towards ADHD, teacher-child~     relationship and child self-esteem.~   "
170720|NCT01330823|"~     The study investigated the role of L-Carnitine supplementation on proinflammatory immune~     response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable~     pancreatic cancer, UICC Stage IV .~   "
170721|NCT01330810|"~     Each year, there are about 150,000 new colorectal cancer (CRC) cases and 50,000 CRC deaths in~     the United States. A safe and effective preventive agent could reduce the burden of~     colorectal cancer as well as reduce the costs associated with screening patients who are at~     high risk of developing CRC. Preclinical studies strongly suggest that curcumin is active~     against multiple pathways implicated in tumor initiation, progression, and metastasis.~     However, little is know how curcumin performs in humans. The investigators propose to enroll~     12 healthy volunteers who will undergo blood draw and rectal biopsy after 7 days of curcumin~     administration. The investigators will look at curcumin preparations with low and high oral~     bioavailability and calculate the blood and rectal tissue concentrations associated with~     these two formulations to determine which preparation produces the highest tissue~     concentrations.~   "
170722|NCT01330797|"~     Purpose To evaluate the cataractogenic effect of intravitreal ranibizumab with the use of~     Lens Opacity Classification System III (LOCS III).~      Settings Cases with a diagnosis of wet AMD were included in this university practice based~     prospective study.~      Methods All cases had monthly injections of intravitreal ranibizumab in the first 3 months;~     subsequently an OCT-guided pro re nata injection regimen has been adopted. All cases had a~     comprehensive eye examination and LOCS III evaluation at baseline and 1, 3, 6 and 12 months~     after the initial injection. Examination outcomes and change from baseline in LOCS III grades~     at 12 months were recorded.~      Results Eighteen eyes of 13 cases (7 female, 6 male) were included in this study. The mean~     age at the baseline was 75,3 + 6,6 years. A mean of 3,4 + 0,7 injections were given on each~     eye. Mean follow-up was 13,83 + 2,33 months. Baseline mean visual acuity improved from 1,04 +~     0,10 logMAR units to 0,76 + 0,26 logMAR units after 3 injections (P < 0.05). At the 12th~     month of follow-up mean visual acuity was 0,71 + 0,27 logMAR units. According to LOCS III~     grades none of the cases had a prominent change in nuclear color, nuclear opalescence,~     cortical and posterior subcapsular opacification throughout the follow-up. IOP remained~     stable at all follow-up points. No complications were recorded throughout the study.~      Conclusion Intravitreal ranibizumab is an efficient treatment in wet AMD. Results of LOCS III~     assessments in this pilot study suggest that intravitreal ranibizumab has no effect on the~     progression of lens opacity.~   "
170723|NCT01330784|"~     To assess the effectiveness of a protocol of ovarian hyperstimulation with urinary~     gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.~      Study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins~   "
170724|NCT01330771|"~     To assess the effectiveness of a protocol of ovarian hyperstimulation combining urinary~     gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females~     undergoing IVF.~      Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins +~     recombinant gonadotrophins~   "
170725|NCT01330758|"~     A study to compare two different tablet formulations of AZD8931 in healthy males and females.~   "
170726|NCT01330745|"~     The purpose of this study is to determine whether cardiopulmonary bypass affects mesenteric~     microcirculatory function, using sublingual evaluation, in cardiac surgery.~   "
170727|NCT01330732|"~     The purpose of this study is to evaluate the accuracy of SPINESCAN® with standard lateral~     x-rays of the spine in patients monitored for kyphosis.~   "
170728|NCT01330719|"~     Although of low prevalence, aggressive periodontitis is a rapid destructive form of~     periodontal disease that initiates at a young age, leading to premature loss of first molars~     and incisors. Little is known on the mechanisms of this disease. It is imperative to~     understand mechanisms of disease to establish proper treatment. We have established a~     controlled study in a comparable population presenting similar aggressive disease~     characteristics to evaluate the mechanisms of this disease. It is the goal of this study to~     determine immunological and microbiological mechanisms responsible for the rapid tissue~     destruction in children with localized aggressive periodontitis and how traditional~     periodontal intervention affects these mechanisms. Important knowledge gained with this~     proposal will aid in defining specific treatment approaches to better control disease~     progression and prevent disease initiation in susceptible individuals.~   "
170729|NCT01330706|"~     The investigators conducted a controlled, prospective randomized study to examine the~     antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.~   "
170730|NCT01330693|"~     The purpose of this study is to find out if children with attention-deficit, hyperactivity~     disorder (ADHD) have a difference in how their brain cells fire or react. The investigators~     also want to find if brain cell firing can tell us how severe of symptoms a child has from~     ADHD. Finally, the investigators want to see if giving an ADHD medication called atomoxetine~     can make the ADHD symptoms in a child better and if the improvement shows a change in brain~     firing.~   "
170731|NCT01330680|"~     Cardiovascular and neuropsychologic effects of coffee are still debated. The precise~     mechanism underlying the actions of caffeine on the cardiovascular and neuropsychologic~     systems is incompletely understood and a considerable variability in the response to coffee~     drinking was observed, in part ascribable to a genetic trait.~      The aim of the study is to evaluate acute cardiovascular and neuropsychologic effects of~     coffee and explore whether such effects are influenced by the genetic asset of caffeine~     metabolism (by a polymorphisms of cytochrome P450 1A2), adenosine metabolism (by~     polymorphisms of adenosine receptor and adenosine monophosphate deaminase) or catecholamine~     receptors (by polymorphisms of adrenergic receptors).~   "
170732|NCT01330667|"~     The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively~     breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3~     mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for~     Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc~     extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or~     to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to~     assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is~     that limited, small amounts of formula administered without a bottle immediately following~     breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at~     increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.~   "
170791|NCT01329861|"~     The aim of this study was to investigate whether an Internet-based cognitive behavioural~     intervention would have an effect on the symptoms of chronic back pain.~   "
170733|NCT01330654|"~     Beta blockers have been shown to decrease the risk of intraoperative cardiac events in~     patients at high cardiac risk. However, they have also been associated with side effects (for~     instance, stroke.) The role of beta blockers in patients at intermediate cardiac risk~     undergoing surgery is controversial. Heart rate variability is a way of evaluating the~     cardiac function of a patient. Decreased heart rate variability is associated with early~     cardiac death in patients with congestive heart failure (CHF) and after a heart attack. It~     has been shown to transiently decrease in patients in hemorrhagic shock after trauma and~     returns to normal after resuscitation in trauma and burn patients. The investigators~     hypothesize that beta blockers will maintain pre operative heart rate variability in patients~     with intermediate risk of cardiac events during operative intervention with laparoscopic~     surgery.~   "
170734|NCT01330641|"~     This study attempts to determine the most accurate route for injection of the subacromial~     bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the~     routes of injection is used. It has not been determined if one route is superior, or if all~     routes are equal in delivering medication into the subacromial bursa, which sits on top of~     the rotator cuff tendons.~   "
170735|NCT01330628|"~     The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with~     balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee~     peripheral artery in-stent restenosis.~   "
170736|NCT01330615|"~     Aims:~      The investigators main purpose is to assess the efficacy of analgesia provide by topical~     lidocaine/prilocaine cream 5% (EMLA)® to pared plantar warts prior to application of liquid~     nitrogen cryotherapy in adults.~   "
170737|NCT01330602|"~     The primary objective of this study is, to instigate a reduction in atherosclerotic burden~     within the carotid arteries in the intervention group compared to the control group and to~     demonstrate parallel improvements in cardiovascular and overall health status relative to~     usual care~   "
170738|NCT01330589|"~     The purpose of this study is to evaluate whether patients post PCI receiving clopidogrel who~     are carriers of at least one CYP 2C19 loss-of-function allele may achieve improved~     pharmacodynamic efficacy of clopidogrel when treated with the CYP 2C19 enzyme inducing agent,~     St. John's wort, as compared with placebo.~      Hypothesis~        1. Reduced platelet reactivity is present in patients receiving St. John's wort as compared~          to placebo when utilized in combination with clopidogrel~        2. The combination or St. John's wort and clopidogrel results in enhanced platelet~          inhibition~   "
170739|NCT01330576|"~     Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical~     illness in neonates with severe necrotizing enterocolitis.~   "
170740|NCT01330563|"~     The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic~     characteristics of CKD-501 in healthy subject.~   "
170741|NCT01330550|"~     The increase in diabetic population of the world is among the top ten causes of death; with~     diabetes always high on the list of causes of death. Diabetes is always relative to other~     major causes of death, (e.g. in cerebral vascular disease, cardiovascular disease and renal~     disease).~      The eating habits and patterns of the diabetic patient are the main causes for poor glycemic~     control. In epidemiological studies, high fiber and low sugar dietary intake can~     significantly reduce the incidence of diabetes.~      The purpose of this study is to investigate the effect of high fiber sugar-free biscuits in~     regulating blood glucose in pre-diabetic subjects.~      The study will be conducted in three periods:~      Period-I:~      The recruitment of 60 pre-diabetic subjects:~      Subjects of blood glucose levels Impaired fasting glucose; IFG: fasting blood glucose ≧ 100~     mg / dL, < 126 mg / dL or Impaired glucose tolerance; IGT: 2 hours postprandial blood~     glucose ≧ 140mg/dL, < 200 mg/dL or clinically judged to be mild or moderate diabetes mellitus~     (HbA1c < 9%).~      In addition to perform pre-test, all subjects also need to complete nutrition counseling and~     nutrition education .~      All 60 subjects are randomly selected into two groups, Group-1,30 subjects, (Placebo group,~     normal fiber and normal sugar biscuit group), Group-2, 30 subjects, (Experimental group, high~     fiber and sugar free biscuit group)~      The period-II:~      Duration: 8 weeks Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit~     group) , All 30 subjects consume 3 servings of Low-fiber, normal sugar biscuits daily.~      Group-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group) All 30~     subjects consume 3 serving of high-fiber, and sugar free biscuits (containing 16 grams of~     fiber) daily.~      Post-period:~      Blood samples of all 60 subjects will be collected to compare with period-I and period-II at~     the first day of 9th week.~      Report of expectation:~      The purpose of this study is to help the pre-diabetic subjects to reduce the risk of becoming~     diabetic through the consuming of high fiber and sugar free biscuits and nutrition education.~   "
170742|NCT01330537|"~     The topological perception theory proposed a precise description for how one organizes the~     visual world that eliminates the vagueness of subjective phenomenology. In addition, the~     topological theory challenges the dominant computational view on the part-to-whole hierarchy~     of visual information processing. Lines of evidence from adult psychophysics, brain imaging~     data, and even honeybee's behavior have supported the notion that the global topological~     properties are the very primitives of visual representation. However, the question of how the~     sensitivity to topological properties originates during development has not been explored~     much. In a previous study, the investigators found that 2- to 6 month old infants could~     reliably discriminate stimuli based on topological differences, but failed to do so based on~     geometric differences. Using familiarization/novelty preference procedure, the present study~     intends to explore the visual sensitivity for topological properties in newborn infants.~     Experiment 1 focuses on whether neonates can discriminate a disk (no hole) and a ring (with a~     hole) that are topologically different, and/or a disk (no hole) and a triangle (no hole) that~     are geometrically different. Experiment 2 focuses on whether neonates can detect a change in~     the number of holes and/or the size of the hole. If newborn infants are only sensitive to~     topological properties and not to geometric properties, this will be a strong proof for the~     claim that topological property is the very primitive visual representation at empirical as~     well as theoretical level.~   "
170743|NCT01330524|"~     In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic~     Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema~     and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided~     in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be injected~     trough vitreal and placebo will be injected in control group. BCVA and Visual field will be~     then measured in these two groups.~   "
170744|NCT01330511|"~     Patients with congenital hydronephrosis will be identified by inpatient consultations~     performed by Dr. Assadi for congenital hydronephrosis and by outpatient problem lists with~     congenital hydronephrosis of Dr. Assadi's existing patients. Given standard evaluation will~     be evaluated to determine if based on initial ultrasound classification an algorithm can be~     developed to target evaluation studies for the initial evaluation. With a goal of targeting~     the few children that have need of additional intervention and minimizing the studies~     performed on children who will spontaneously resolve.~   "
170745|NCT01330498|"~     This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed~     to assess the longitudinal pharmacokinetic, pharmacodynamic, immunological, and biochemical~     sample collection with MRI and relapse analysis of a Tysabri patient cohort. The study hopes~     to identify secondary and tertiary risk stratification markers that would aid in the clinical~     management of patients who are JC antibody positive.~   "
170746|NCT01330485|"~     Nested within a longitudinal study investigating emotion regulation skills and subsequent~     depressive symptoms in major depressive disorder, the effectiveness of a systematic affect~     regulation training (ART; Berking, 2010) is evaluated in a randomized controlled trial.~   "
170747|NCT01330472|"~     Study to evaluate if Xanax sustained release tablets manufactured at two different sites~     provide similar drug levels in the blood.~   "
170748|NCT01330459|"~     The purpose of this study is to determine whether preoperatively administered~     hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.~   "
170749|NCT01330446|"~     The goal of this clinical research study is to learn if armodafinil can reduce fatigue and~     other common symptoms in patients that have received treatment for head and neck cancer.~   "
170750|NCT01330433|"~     This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the~     effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on~     the formation of mediastinal and pericardial adhesions in children undergoing staged surgical~     reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn~     Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated~     by drainage post-operatively through surgical site drainage output.~   "
170751|NCT01330420|"~     The linkage between the Massachusetts General Hospital (MGH)-Community Health Associates and~     the MGH-Benson Henry Institute for Mind-Body Medicine began in order to address the concern~     of providing affordable, easily accessible, culturally appropriate behavioral medicine~     interventions for low income patients served by MGH Community Health Centers, as well as the~     desire to demonstrate the efficacy and economics of these interventions. Since depression was~     such a prevalent issue among health center patients, with a significant impact on health care~     service utilization, it was decided to focus on offering Mind/Body services to this~     population first.~   "
170752|NCT01330407|"~     The investigators intend to conduct a comparative, monocentric prospective double-blind study~     with intra-subject randomization, to compare the results on wound healing of 2 adjuvant~     treatments to Meek micrografting technique : Cultured Epidermal Autografts and cryopreserved~     skin allografts.~   "
170753|NCT01330394|"~     Alcohol dependency is the most frequent addiction leading to a massive burden of both,~     patients health, and economy. Present therapeutic concepts suffer from limited efficacy, and~     thus new innovative therapies are needed. Neuroscientific studies have shown that prefrontal~     function in alcohol-dependent patients is impaired, leading to cognitive disturbances, and~     continuation of dependent behaviour. The results of pilot studies demonstrate that activation~     of prefrontal cortices via non-invasive brain stimulation improves cognitive performance in~     healthy subjects, and diminishes dependency-related behaviour in patients. The investigators~     aim to develop a stimulation protocol suited to induce a clinically relevant improvement of~     prefrontal functions in patients suffering from alcohol dependency. Therefore, the~     investigators will develop stimulation protocols which are able to modulate prefrontal~     activation for a much longer time course than those currently available, and will explore if~     the induced physiological alterations translate to respective cognitive improvements and~     reduction of addictive behaviour.~   "
170754|NCT01330381|"~     To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional~     constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label~     comparator (PEG) controlled part will follow, to document safety and tolerability up to 24~     weeks.~   "
170755|NCT01330368|"~     The purpose of this study is to compare healthy children to children who have systemic lupus~     erythematosus (SLE). SLE is a childhood disease that has high risk for low bone mass and~     vertebral compression fractures.~   "
170756|NCT01330355|"~     The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin~     0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when~     administered three times daily (TID) for seven days to neonatal subjects who are 31 days or~     younger on the day of randomization (Visit 1).~   "
170757|NCT01330342|"~     The study's chief objective is to observe the evolution of cellular (in terms of expression~     of transmembrane transporters and their transcriptional regulators) and viral resistance (in~     terms of development of mutations in the HIV genome that may confer resistance to future~     treatment for HIV) in HIV-infected patients with lymphoma.~   "
170758|NCT01330329|"~     The purpose of this study is to evaluate the effectiveness of a technology-based system (the~     Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40~     kg/m2). The investigators will compare two 6-month interventions: 1) a standard behavioral~     weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of~     the Body Media FIT system (SBT+FIT). The Body Media® FIT system is a novel weight loss tool~     consisting of an armband that measures energy expenditure, a digital display watch that~     provides real time physical activity and energy expenditure feedback, and access to a~     system website which allows individuals to track their food intake and set exercise and~     dietary goals. We will examine differences in physical activity, weight loss, and program~     adherence between groups.~   "
170759|NCT01330316|"~     The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of~     treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon~     (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from~     PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.~   "
170760|NCT01330303|"~     It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,~     02 sequences, and 02 periods, in which the volunteers receive, in each period, the test~     formulation or the reference formulation, under fed conditions.~   "
170761|NCT01330290|"~     The study objective is to evaluate advantages and disadvantages of Neupro® versus oral~     anti-Parkinson medication by caregivers and physicians in idiopathic Parkinson's Disease~     patients requiring caregiver support in nursing home or outpatient care settings.~   "
170762|NCT01330277|"~     Hunter Syndrome (mucopolysaccharidosis II [MPS II]) is a lysosomal storage disorder caused by~     reduction or absence of the iduronate-2-sulphatase enzyme has still the problem of the~     difficulties of a simple and reliable analysis for the primary diagnosis but also for the~     follow-up of the disease. Especially in the cases of female carriers which have been reported~     to have some symptoms of MPS II due to skewed X-inactivation makes the diagnosis complex.~     However, early diagnosis and treatment of disease complications with enzyme replacement~     therapy can improve quality of life.Therefore the primary aim of our project called BioHunt~     is the development of a new plasma biomarker for the early and sensitive diagnosis of the~     disease. The secondary aim is the testing for clinical robustness, specificity and long-term~     stability of the biomarker.Within the scope of the study the investigators would like to~     collect in the next 12 months from about 80 patient's plasma and in parallel a simple~     documentation of the clinical data.~   "
170763|NCT01330264|"~     The SIM City study seeks to explore for the variance in practice that is associated with~     nursing and medical care of patients with brain pressure (ICP) monitors. The underlying~     hypothesis is that there is not a consistent pattern of care throughout the U.S., rather,~     there is a wide range of practice patterns that are used to monitor and treat ICP.~   "
170764|NCT01330251|"~     This study will investigate the effects of gastric bypass surgery on type II diabetes. The~     study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients~     without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients~     having gastroscopy, but no surgery). Targeted enrollment is 30 patients per group. Samples of~     intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after~     surgery during gastroscopy. Meal test with incretin measurements, and feces and blood~     samplings are performed before and after surgery~      Hypotheses are:~        -  The pathogenesis of type II diabetes is linked to changes in the expression of~          intestinal endocrine cells~        -  The changes in the incretine excretion after the gastric bypass surgery partly explain~          the amelioration of type II diabetes~        -  The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the~          development of atherosclerosis~        -  The immunologic functions of the intestine are changed by the gastric bypass surgery~          attenuating systemic inflammation~        -  The gastric bypass surgery changes cholesterol and bile acid metabolism~        -  The gastric bypass surgery changes the fecal microbiota~      Primary end points are:~        -  Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum~        -  Changes in the incretine secretion studied with liquid meal test~        -  Changes in the oxidation of lipoproteins~        -  Changes in the immunologic markers in ventricle, duodenum and jejunum~        -  Changes in the amounts of phytosterols, cholesterol metabolites and bile acids~        -  Changes in fecal microbiota~   "
170765|NCT01330238|"~     Modic changes are associated with low back pain (LBP) both in clinical and general~     population-based samples. Type I changes are regarded as more likely to be painful than type~     II changes. Several studies suggest that type I changes are inflammatory in nature.~   "
170766|NCT01330199|"~     The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of~     mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal~     tissues. This will be accomplished by determining the pharmacokinetic disposition and dose~     proportionality of four antiretrovirals (tenofovir, emtricitabine, maraviroc, and~     raltegravir) in human rectal and cervicovaginal fluid and rectal, cervical, and vaginal~     tissue.~   "
170767|NCT01330186|"~     The purpose of the study is to evaluate the predictive value of 18F-fluoromisonidazol-PET~     (FMISO-PET), 2-18F-fluoro-2-deoxy-d-glukose-PET-CT (FDG-PET-CT), Diffusion-Weighted Magnetic~     Resonance Imaging (DWI-MRI) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging~     (DCE-MRI) for patients with anal cancer receiving radiation therapy +/- chemotherapy~     (Cisplatin and 5-FU).~   "
170768|NCT01330173|"~     This phase I trial studies how well vismodegib after stem cell transplant works in treating~     patients with high-risk first remission or relapsed multiple myeloma. Vismodegib may slow the~     growth of cancer cells. Giving vismodegib after autologous stem cell transplant may kill more~     multiple myeloma cells.~   "
170769|NCT01330160|"~     If the risk of dementia occurrence after stroke is well known, few data exist about the~     factors influencing positively or negatively the developement of cognitive disorders or~     dementia. The aim of the study is so to determine prospectively the clinical, biological,~     lesional and pharmacological factors associated with post-stroke dementia by the long-term~     follow-up of a stroke patient cohort.~   "
170770|NCT01330147|"~     The principal aim of this study is to provide vital current data on the prevalence,~     distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This~     data is an essential requirement for the assessment, development and evaluation of cost~     effectiveness of prophylactic vaccination and screening programmes.~   "
170771|NCT01330134|"~     The objective of our study is to determine if technique of lidocaine administration can~     decrease pain perception.~      Hypothesis: There will be a significant difference in pain perception between patients who~     are given lidocaine on the skin surface prior to subcutaneous injection and patients who are~     given only subcutaneous injection by standard approach.~   "
170772|NCT01330121|"~     The purpose of the study is to evaluate patient adherence with discharge diabetes medications~     up to 120 days following pharmacist counseling during hospital stay about diabetes self~     management~   "
170773|NCT01330108|"~     The primary objective of this study is to assess the safety and tolerance of changing~     patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial~     hypertension.~   "
170774|NCT01330095|"~     To evaluate the effects of early administration of probiotics on acceleration of enteral~     feeding, and on growth of very low birth weight infants, newborn infants with birth weight~     less than 1500g are administered Bifidobacterium bifidum twice a day.~   "
170775|NCT01330082|"~     The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the~     adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source~     in the treatment of chronic periodontitis.~   "
170792|NCT01329848|"~     This project will develop clinically useful, objective measurements of accommodative~     insufficiency and fatigue using continuous autorefraction recordings. The development of~     these procedures will help vision care professionals diagnose and treat accommodative~     anomalies.~   "
170776|NCT01330056|"~     This is a prospective randomized controlled trial comparing functional organ preservation~     surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for~     patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and~     hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to~     preserve the organ function without compromising oncologic safety and survival.~   "
170777|NCT01330043|"~     Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and~     Santa Clara counties will serve as the target population for this study. A total of 400~     smokers meeting eligibility criteria will be randomized. Treatment will include both open~     label and extended treatment phases. Randomization. Participants will be randomized to~     extended therapy or control conditions at baseline (prior to open label treatment) and the~     analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary~     hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher~     prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the~     Supportive therapy Control treatment.~   "
170778|NCT01330030|"~     Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of~     this study is examine whether selegiline, given in the form of a skin patch, is effective in~     stopping smoking.~   "
170779|NCT01330017|"~     The trial will evaluate the nasal congestion symptom relief of the approved 10 mg~     phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo~     in participants with histories of seasonal allergic rhinitis, using loratadine as background~     medication.~   "
170780|NCT01330004|"~     Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal~     disease) population. In dialysis patients, however, it has been shown that higher blood~     pressure levels may actually be beneficial to patient outcomes. Dynamics of blood pressure~     evolution over time has not been previously studied in dialysis population. The investigators~     aim to understand how both blood pressure levels and blood pressure changes over time predict~     patient survival.~   "
170781|NCT01329991|"~     PLX115-02 is a phase 1b study to assess how the study drug, PLX5622: 1. affects the body, 2.~     how the body affects PLX5622 3. the interaction of PLX5622 with Methotrexate and 4. the~     safety of PLX5622 in rheumatoid arthritis patients taking Methotrexate~   "
170782|NCT01329978|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir~     (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin~     (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.~   "
170783|NCT01329965|"~     The purpose of this study is to establish the safety and feasibility of low dose LPS~     administration to a small subset of humans in preparation for a larger USDA funded study~     examining what is the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day~     delivered as fish oil supplements) that significantly attenuates the inflammatory response~     the investigators wish to examine the effects of an endotoxemia model for inducing~     inflammation. Based on previous research, low dose LPS administration affects metabolism in~     humans with only minimal clinical effects (such as flu like illness). Therefore, each of~     the six subjects included in this small pilot study will receive a low dose of LPS and~     placebo in order to learn more about the metabolic changes that occur during administration~     and inflammation. The investigators hypothesis that LPS administration will elicit only~     minimal clinical effects (such as flu like illness) when compared to placebo (saline--water~     with the same amount of salt as in your blood).~   "
170784|NCT01329952|"~     The investigators will identify possible participants using our database of previously~     treated hepatitis c patients. The investigators will identify those who have documented~     evidence of current injecting drug use as a risk factor for acquisition of the virus. The~     investigators will then search for those who have received curative treatment between~     2004-2010. This covers all patients in the current database. The investigators will include~     those over 18 years old. The investigators will exclude those patients who are coinfected~     with either hepatitis B or HIV. This is because both of these conditions can accelerate liver~     damage when in combination with hepatitis c.~      The possible participants identified will be sent an information sheet giving a simple and~     clear outline of the proposed research. The investigator will try to obtain an au to date~     residential address from the PAS system in the NHS or through confirmation from the patients~     GP or drug worker. It will explain the purpose of the study, why they have been chosen, what~     taking part will involve, the potential advantages and disadvantages of taking part and that~     everything will be kept confidential. It will also outline who is conducting the study, how~     any expenses will be paid and contact details for any problems/complaints that arise.~      Those interested in taking part will attend an appointment at the hospital after they have~     had the opportunity to read through the information leaflet. They will be given time to ask~     any questions they have about the study and have them answered fully. They will then be asked~     to sign two copies of a consent form in order to take their participation any further. Once~     this is complete they can have their first 'liver assessment'. The assessment will take~     approximately 30-45 minutes to complete.~      The investigators will take three blood samples from them (approximately 10mls of blood or 4~     teaspoons full). One sample is to measure the levels of hepatitis C virus in the blood. This~     will tell us whether there has been reinfection with hepatitis C. The second sample is to~     measure the levels of inflammation within the liver and the third sample is to measure the~     full blood count. The investigators will then perform a liver scan called a fibroscan. This~     is a noninvasive test similar to an ultrasound (that pregnant women have) and gives a reading~     that can tell us about any 'stiffness' in the liver. It takes approximately five to ten~     minutes to complete and involves the patient lying on their back with their right arm above~     their head for the duration of the scan. Following the scan the investigators will ask the~     participant to complete a short questionnaire. This will include questions about past and~     current drug use as well as any alcohol use. The answers will be kept strictly confidential.~     They will be stored in the researchers locked office and have no direct participant~     identifiers on them. They will simply have a study number on them.The participant will then~     be thanked for their time and offered £30 to cover all travel and time expenses for their~     visit.~      They will be invited to attend for a further liver assessment one year after their first one~     and annually thereafter. This is optional and they are of course free to withdraw from the~     study at any time without needing to give a reason.~      The investigators will be identifying participants at different points in time following~     their curative treatment. For example some will have been cured 5 year ago whereas other will~     have been cured 6-12 months ago. This will increase the number of patient years follow up.~     Once the investigators have done the first set of liver assessment the participants will then~     be followed prospectively for as long as they wish to participate.~      For the purpose of my higher degree I will present the data I have following two years of~     'liver assessments'.~   "
170785|NCT01329939|"~     Background: In recent years, the prevalence of both asthma and obesity has risen dramatically~     among children and adolescents in the United States. Given the concurrent rise in the two~     epidemics, there may be an underlying link. Obesity contributes to asthma severity and~     control, and may play a role in its underlying cause. Obesity is associated with a state of~     heightened inflammation that may lead to an increase asthma symptoms and severity. Obese~     adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better~     asthma control than those treated with other standard asthma medications. The use of~     montelukast in obese children and adolescents has not been specifically studied.~      Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and~     objective markers of asthma to a greater degree in obese, as opposed to non-obese children~     and adolescents. The investigators would like to determine if the use of montelukast will~     improve objective asthma scores, pulmonary function, markers of inflammation and medication~     use to a greater degree in obese as opposed to non-obese children/adolescents.~      Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a~     tailored approach focused on obese asthmatic children may help reduce the burden of this~     disease, health care costs and potential long-term complications as these children enter~     adulthood. Furthermore, this study may help clarify the underlying mechanisms that link~     asthma and obesity. Although this proposal is focused on one medication, it provides an~     example of how certain medications may have differential efficacy in the obese asthmatic.~   "
170786|NCT01329926|"~     The aim of this study is to develop and optimize methods to isolate, propagate and~     differentiate adult human neural stem cells from patients with degenerative neurological~     disorders like Parkinson's disease.~   "
170787|NCT01329913|"~     This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in~     HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected~     participants who will be randomized to receive either MK-6325 or placebo. If the drug is~     shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected~     participants who will be randomized to receive either MK-6325 or placebo.~   "
170788|NCT01329900|"~     The goal of this clinical research study is to learn if it is possible to collect stem cells~     after ofatumumab and chemotherapy treatment. This study will also evaluate side-effects,~     number of stem cells collected, and the number of procedures that are needed to collect~     enough stem cells.~   "
170789|NCT01329887|"~     This study is an evaluation of the effect of ketanserine on sublingual microcirculation in~     intensive care patients with severe sepsis.~   "
170790|NCT01329874|"~     The purpose of this study is to determine whether Gow Gates block injection is more effective~     than conventional alveolar nerve block in anesthetising mandibular molars with acute~     pulpitis.~   "
170793|NCT01329835|"~     Prepregnancy obesity, defined as a body mass index (BMI) of 30kg/m² or more, shows a strong~     association with pregnancy and birth complications for both the mother and her child. Most~     consequently reported maternal risks include an increased risk for gestational diabetes,~     hypertension and pre-eclampsia, increased incidence of induction of labour, operative~     delivery, postpartum haemorrhage, anaesthetic risks as well as risk for infections and~     thromboembolic complications. Fetal risks include miscarriage, neural-tube defects, heart~     defects, macrosomia and stillbirth. Initiation and continuation of breastfeeding is more~     complicated in obese women than in normal weight women. Also in later life chronic diseases~     can put the mother and her baby's health at risk. The Institute Of Medicine (IOM) guidelines~     suggest a gestational weight gain (GWG) to be limited to 5 - 9 kg (11-19,8 lb) in obese women~     in order to minimize the synergetic negative health consequences of excessive weight gain for~     both the obese mother and her child. Preventing excessive weight gain during pregnancy and~     postpartum weight retention is also important in the prevention of overweight and obesity~     among women of reproductive age. Obese women in general have a poor diet quality and are more~     exposed to psychosocial factors like anxiety and feelings of depression than normal weight~     women.~      The aim of this project is to perform a randomized controlled trial (RCT) in order to~     evaluate the effects of life-style intervention (psycho-education by a midwife during 4~     prenatal sessions) on pregnancy and birth outcomes. Main dependent variables are gestational~     weight gain and anxiety and depression. Obesity is a modifiable risk factor and optimizing an~     adequate gestational weight gain with attention to psycho-social factors, can reduce the need~     for adverse perinatal outcomes.~   "
170794|NCT01329822|"~     The aim of this randomized controlled study was to evaluate the effects of CR on circulating~     fetuin-A levels in obese humans with type 2 diabetes based on monitoring energy intake and~     energy expenditure by daily activity. Furthermore, the investigators examined the~     relationship between the changes of fetuin-A levels induced by CR and cardiovascular risk~     parameters including atherogenic lipid profile, visceral fat area (VFA), brachial artery~     endothelial function, and carotid IMT.~   "
170795|NCT01329809|"~     This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal~     carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in~     their liver.~   "
170796|NCT01329796|"~     Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An~     altered immune system with elevated levels of cytokines in the peritoneal fluid as well as~     increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in~     endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on~     nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent~     an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects~     related to hormonal treatments. A double blind randomized clinical trial, was carried out to~     evaluate pertubation with lignocaine as a therapy for dysmenorrhea.~   "
170797|NCT01329783|"~     Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the~     maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral~     Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort.~     The rates of specific clinical adverse events in this identified patient population will be~     compared with the rates of these events in the participants of the MOTIVATE trials.~   "
170798|NCT01329770|"~     The Fragile X syndrome (FXS) was first described by Dr. Martin and Dr. Bell in 1943, in~     families with several patients affected by sex-linked mental disability. This disorder is the~     most common cause of inherited mental disability. The prevalence of the Fragile X syndrome~     has been established at 1 in 2,500 males and 1 in 4000 females.~      Despite moderate to severe mental retardation, fragile X patients exhibit macroorchidism, an~     elongated face, long ears, connective tissue dysplasia, hyperactivity, autistic-like and~     stereotypical behaviours, speech delay and increased sensory sensitivity.~      Objective: To evaluate the effect of the combination of the antioxidant Ascorbic acid and~     tocopherol, as therapy of the Fragile X Syndrome in young males.~      Hypothesis: It is proposed that part of the pathophysiology of the central nervous system in~     the animal model of the fragile X syndrome may be determined by oxidative stress. In~     addition, Fragile X patients showed a significantly low level of ascorbic acid in plasma. The~     biochemical characteristics of oxidative stress may be reversed in the FMR1-KO mice, by a~     chronic treatment with antioxidant compounds such as tocopherol or melatonin, it may also~     normalize several hallmarks of the Syndrome such as hyperactivity, anxiety and cognitive~     deficits. The normalization of the oxidative stress is proposed as a new therapeutic pathway~     to alleviate conditions caused by an excess of free radicals that are crucial in~     neurodevelopmental diseases such as autism, down syndrome and other diseases of the central~     nervous system.~   "
170799|NCT01329757|"~     Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of~     exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six~     months the pharmacological treatment will be associated to rehabilitation treatment.~      The main hypothesis is that GH can improve motor function of patients with traumatic spinal~     cord injury below the lesion level. The hypothesis is based on possible effects of GH at~     muscle and synaptic level. GH can also promote axonal growth and regeneration.~      Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by~     third parties and blinding in the analysis of data (triple-blind design).~      Duration of intervention and monitoring: 364 days.~      Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale~     (motor score)~   "
170800|NCT01329744|"~     This study examines the effects of recombinant insulin like growth factor - I on body~     composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of~     metabolic disease.~   "
170801|NCT01329731|"~     The aim of this study is to monitor the effect of intraoral topical high fluoride application~     on the development of white spot lesions (WSL) after orthodontic treatment with multibracket~     appliances and to compare it to a placebo.~   "
170802|NCT01329718|"~     Epigenomics has identified methylated gene regions that are specific for colorectal cancer~     (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified~     as a particularly robust methylation marker for detection of CRC. Epigenomics is currently~     developing a blood based CRC screening test based on Septin 9 and is performing a large~     prospective clinical trial showing its clinical utility in a population at average risk for~     CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop~     pre-analytical and analytical workflows as well as molecular assays making possible the use~     of Septin 9 methylation in the clinical routine.~   "
170803|NCT01329705|"~     The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX)~     injections (tone management) and dynamic splinting (contracture reduction) for improving gait~     patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and~     resultant excessive plantarflexion.~   "
170804|NCT01329692|"~     Purpose and objective: To identify in the early post-operative period following laparoscopic~     Roux-en-Y gastric bypass patients likely to fail to progressively lose weight in expected~     fashion, and to institute intervention and assess for its efficacy.~      Study activities and population group: Patients identified to have poor weight loss (≤ 11%~     of excess weight loss) at 1 month will be randomized into a control versus study group.~     Intervention for subjects randomized to the IV arm will be by enrollment in the Back on Track~     program. This is a seven-week group education, counseling, nutrition, exercise, and~     journaling program of the Duke Weight Loss Surgery Center designed to help postoperative~     bariatric surgery patients who are failing to progressively lose weight resume an expected~     pattern of weight loss and improved overall outcome.~      Data analysis and risk/safety: Data will be collected and analyzed by the identified~     investigators. The goal of data analysis is to uncover any difference in the EWL of subjects~     who underwent intervention for falling in the lowest EWL quartile when compared with those~     who did not undergo intervention, and determine the statistical significance of any such~     difference. There are no physical risks associated with this study. There is, however, the~     potential risk of loss of confidentiality. Every effort will be made to keep your information~     confidential.~   "
170805|NCT01329679|"~     Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart~     rhythm in healthy subjects.~      Study design: Double blind, placebo controlled, cross-over~      Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no~     other medical conditions.~      Intervention: 5 Hour Energy or Placebo~      Primary outcome: Change in office systolic blood pressure~   "
170806|NCT01329666|"~     Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people~     every year. In the presence of this condition, the parathyroid glands produce excessive~     amounts of parathyroid hormone (PTH), which regulates calcium levels. The high levels of~     parathyroid hormone remove too much calcium from bones, and then deposit the excess calcium~     in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened~     by excess calcium loss which weakens bone structure. Other affected organs include the~     skeleton (calcium loss leads to a weakening of the skeleton), and the kidneys (high blood~     calcium can lead to kidney stones).~      It is now evident that the majority of patients with even mild Primary Hyperparathyroidism~     are vitamin D deficient. In 2009, new international guidelines for the management of~     asymptomatic PHPT direct physicians to measure 25-hydroxyvitamin D (D3 or 25-OHD) in all~     patients, and to replete the reserve of vitamin D when the level is low (< 20 ng/ml).~     However, no recommendations for vitamin D repletion are given, because of limited data~     regarding the effects of vitamin D repletion, appropriate dosing and safety. Therefore, there~     is an urgent need for data upon which to base such recommendations, as well as are data on~     the effects of such treatment upon bones.~      Subjects with low vitamin D3 levels will be selected for this trial. They will be given~     enough vitamin D3 to raise their low blood levels from a low to a normal range. The~     assessments in this study, including the quadruple label bone biopsy, will allow us to~     document the short term effects of administering vitamin D3 on changes in bone.~      All participants enrolled in this trial will be vitamin D3 deficient. Participants will take~     an antibiotic (tetracycline) 4 times a day to mark the starting point from which bone changes~     will be assessed. After 3 days of tetracycline, a 12 week course of vitamin D3 or placebo~     will be initiated. Six of 7 participants will receive the study drug (active vitamin D3),~     while 1 in 7 will receive a placebo (sugar pill). Ten weeks later, another 3-day course of~     tetracycline will be given. At the end of 12 weeks, a bone biopsy will be done. A small piece~     of bone (about the size of a pencil eraser) will be removed from the hip (iliac crest). The~     bone will be analyzed to determine the effect of vitamin D3 on primary hyperparathyroidism.~      There will be 4 study visits: Screening, Baseline, Week 8, and Week 12 when the bone biopsy~     will be performed.~      Study Procedures:~      Medical and Social History~      Blood tests (drawn at the study center and local Quest Lab)~      24-Hour urine collection for calcium and creatinine excretion~      Abdominal X-ray (to assess for kidney stones)~      Transiliac crest Bone Biopsy~   "
170807|NCT01329653|"~     The purpose of this study is to test the hypothesis that aerobic exercise leads increased~     cerebral blood volume in the dentate gyrus of the hippocampus in a sample of young and older~     adults.~   "
170808|NCT01329640|"~     The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of~     metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced~     HER2-positive breast cancer.~   "
170809|NCT01329627|"~     The purpose of this study is to determine whether weekly paclitaxel followed by weekly~     doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor~     (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.~   "
170810|NCT01329614|"~     The purpose of this study is to determine whether Cue Extinction Training will reduce relapse~     rates in cigarette smokers using the patch to quit.~   "
170811|NCT01329601|"~     The study aims to detect the effect of a structured cognitive rehabilitation program, teh~     stage specific intervention STACog, on cognitive performance and functional activation in~     fMRI in a group of patients with mild cognitive impairment and dementia due to Alzheimer's~     disease compared to a waiting group control sample. Baseline performance in cognitive tests~     and fMRI will further be assessed compared to healthy control subjects.~   "
170812|NCT01329588|"~     In the early years of the HIV epidemic in Africa, female sex workers (FSWs) were identified~     as a high-prevalence, high-incidence, core group among whom the extraordinary prevalence of~     other sexually transmitted infections (STIs) facilitated transmission of the virus to their~     clients, who then infected low-risk women not involved in the sex trade. In resource-poor~     settings, control of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) among FSWs is~     difficult. The purpose of this study is to determine whether periodical antibiotic treatment~     (PAT) is effective in controlling these infections among West African FSWs.~      The study is designed as a cluster-randomized double-blind placebo-controlled trial conducted~     in West Africa. The study population consists of seaters FSWs who work from their homes in~     well-defined areas. Clusters will be paired according to their size and demographic~     characteristics of FSWs and clients. Within each pair, one cluster will be randomly allocated~     to the intervention and the other to the placebo group.~      At enrollment, participants will be interviewed, a pelvic examination performed, cervical~     swabs obtained for NG and CT polymerase chain reaction (PCR), and current cervicitis or~     vaginitis managed syndromically. Blood specimens will be obtained for HIV testing. All~     participants will be given free condoms and counseled on risk reduction.~      Monthly follow-up will be conducted within FSW communities, alternating with clinic visits~     where cervical samples will be collected. Study drugs (azithromycin 1 g and ciprofloxacin 500~     mg, and their identical placebos) will be distributed every month according to a predefined~     schedule: directly-observed intake of azithromycin at months 1, 4 and 7, and ciprofloxacin at~     months 2, 3, 5, 6, 8 and 9.~      Data will be analyzed with SAS. The investigators will assess the time trends in NG and CT~     prevalence separately in both study groups using χ2-for-trend.~   "
170828|NCT01329380|"~     This study of Humira will be conducted to clarify the following with regard to the treatment~     of ankylosing spondylitis with this drug:~        -  Unknown adverse drug reactions (especially important adverse drug reactions)~        -  Incidence and conditions of occurrence of adverse reactions in the clinical setting~        -  Factors that may affect the safety and effectiveness of Humira~   "
170982|NCT01327326|"~     The aim of this proposal is to characterize pain inhibition in healthy controls and~     Temporomandibular Disorder (TMD) patients with two models of endogenous pain modulation~     (off-set analgesia; conditioned pain modulation), and to investigate the function of the~     endogenous opioid system in these responses by using pharmacological blockade of the opioid~     receptor.~   "
170813|NCT01329575|"~     There is no single method to investigate mediastinal LN invasion. Hence, a patient may have~     to undergo several tests and procedures. Noninvasive and invasive approaches are employed.~     Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA)~     and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are~     gaining importance in mediastinal staging.5 They provide ultrasonographic images and permit~     needle aspiration under direct vision for cytology specimen analysis. As more evidence is~     being accumulated on these staging approaches, the number of cervical mediastinoscopies,~     considered as the gold-standard for mediastinal staging, is diminishing.~      Color Doppler LN characteristics with endoluminal ultrasound (US) is only mentioned in a~     small number of studies and needs to be further investigated.13,14 With the good results~     obtained with superficial US, it seems reasonable to believe that color Doppler~     characteristics would increase accuracy in detecting malignancy of mediastinal LNs with~     endoluminal US.~   "
170814|NCT01329562|"~     The purpose of this study is to (1) evaluate pain-free efficacy of Treximet™ following~     treatment of menstrual migraine, (2) investigate levels of Calcitonin gene-related peptide~     (CGRP), estrogen, cortisol, vasoactive intestinal peptide (VIP), alpha (a)-amylase,~     Prostaglandin E2 (PGE2), Prostaglandin I2 (PGI2) and beta (ß)-endorphin in saliva before and~     after Treximet™, (3) evaluate efficacy of Treximet™ to return to baseline levels following~     treatment, and (4) correlate estrogen in saliva vs. urinary estradiol at mid-luteal, onset of~     menstrually-related migraine, and after successful treatment with Treximet™.~   "
170815|NCT01329549|"~     This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to~     treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in~     patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma~     or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with~     carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression~     is observed.~   "
170816|NCT01329536|"~     The purpose of this clinical research study is to determine if a specific genetic allele is~     involved with the development of agitation in patients with late-onset Alzheimer's Disease~     (AD). The study will compare the results of genetic testing between two groups: individuals~     with late-onset AD who show signs of agitation and individuals with late-onset AD who do not~     show signs of agitation.~   "
170817|NCT01329523|"~     The purpose of this study is to determine if insulin-like growth factors (IGF) play a role in~     the development of dementia, specifically Alzheimer's disease (AD). The study will compare~     results from genetic testing between patients with AD and two other groups: younger~     biological family members of the AD patients and individuals without AD matched by age to the~     AD patients.~   "
170818|NCT01329510|"~     This study will investigate the effects of methylphenidate on sleep in adults with Attention~     Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.~   "
170819|NCT01329497|"~     Hyperphosphatemia is highly prevalent in PD patients, and it is an independent risk factor~     for all-cause and cardiovascular mortality in these patients. Effective treatments are~     limited in suppressing plasma phosphorous. Because of the nearly linear relationship between~     protein and phosphorus intake, high dietary protein intake (DPI, 1.2-1.3g/kg/d recommended by~     KDOQI) would load high phosphorus burden in PD patients. It is suggested that~     hyperphosphatemia is hard to avoid under such a DPI level, even as the patients take~     sufficient phosphorus blinders and receive high PD dosage. The present study is to~     investigate whether systemic dietary instruction would show effects on control of~     hyperphosphatemia in PD patients.~   "
170820|NCT01329484|"~     The purpose of this study is to determine whether the use of computerized systems in 2 common~     non pharmacological therapies (cognitive training and reminiscence therapy) will improve the~     cognitive function of patients with mild to moderate Alzheimer's disease (AD), or at least~     delay its deterioration. In addition, the investigators hypothesize that using the~     computerized systems will result in improved well-being of the patients and their main~     caregivers / family members, and in improved patient-caregiver and patient-family relations.~   "
170821|NCT01329471|"~     The purpose of this study is to elucidate the role of RUNX1 in Acute Myeloid Leukemia (AML),~     in particular, the transcriptional regulation of genes by mutated forms of this protein. This~     research will study the effect of mutations found in AML patients~   "
170822|NCT01329458|"~     The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation~     of de novo focal liver lesions in clinical practice, in a prospective multi-center design.~   "
170823|NCT01329445|"~     The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue~     product used for the repair of cartilage damage in the knee. This product has been on the~     market since 2007 and implanted in more than 10,000 patients around the country.~   "
170824|NCT01329432|"~     Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is~     thought to have some advantages compared with mechanical ventilation in premature infants. In~     addition, early surfactant administration has been shown to be superior to delayed use. The~     aim of this pilot study was to describe the feasibility of TAKE CARE (early administration of~     surfactant in spontaneous breathing) procedure and compare its short-term and long-term~     results with InSurE procedure.~   "
170825|NCT01329419|"~     An open label, multi-centre, non-interventional post-marketing surveillance to monitor the~     safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to~     the prescribing information~   "
170826|NCT01329406|"~     The present study will aim to evaluate the efficacy of milnacipran in the treatment of pain~     due to osteoarthritis (OA), that is, to determine whether milnacipran provides superior~     efficacy to placebo in patients with OA. Milnacipran is a serotonin-norepinephrine reuptake~     inhibitor (SNRI) that is currently approved in the United States in the treatment of major~     depressive disorder and fibromyalgia. There is increased evidence to suggest that SNRIs may~     be effective in the treatment of chronic pain conditions, such as OA.~      The hypothesis in this study is that the survival time (time from randomization to loss of~     efficacy) of milnacipran group is superior to that of placebo group.~   "
170827|NCT01329393|"~     This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and~     collect qualitative data concerning a brief money management intervention for people disabled~     by psychiatric illnesses.~   "
170829|NCT01329367|"~     The consumption of diets enriched in proteins (legumes and fish) or antioxidant (fruits and~     vegetables) could have beneficial effects beyond those of the caloric restriction on~     biomarkers of the inflammatory and oxidative status. OBJECTIVE: To address the effect of a~     10-week dietary intervention aimed to weight loss in obese or overweight children (7-15 aged)~     on genomics, particularly the changes in the expression of genes related to the inflammatory~     status and oxidative stress. METHODOLOGY: 44 Navarra children and adolescents of both sexes~     from Pediatric Endocrinology Services at different Hospitals in Pamplona will be recruited.~     The effect of the intensive consumption of different groups of food will be evaluated:~     legumes and fish ( diets in proteins) and vegetable and fruits (rich diets in antioxidants).~     Before and after the intervention, the following items will be analyzed: (1) the diet of the~     subjects, (2) body composition and 3 magnitudes related to biological and development~     parameters, being: (3) lipid and metabolic phenotypic profile; (4) markers of the~     inflammatory status and oxidative stress, and (5) the genomic profile. The dietary programme~     will be implemented both in group workshops addresseded to patients and their family, and in~     individual sessions with the pediatricians and/or registered dieticians. Finally, the~     programme efficacy will be evaluated by the scoreboards integrated in the 5 variables already~     mentioned.~   "
170830|NCT01329354|"~     Nowadays, therapy with monoclonal antibodies is considered to be a standard treatment that~     increases the rate of remissions and the overall survival in patients with follicular~     lymphoma. Nevertheless there are an important number of patients who do not benefit from this~     therapy. A way to improve the efficiency of monoclonal antibodies therapy could be to improve~     the activity of the effector arm of the immune system. A strategy that has been proposed to~     obtain this improvement is the utilization of lymphocyte activated killer (LAK) cells. In~     addition, the combination of LAK cells with monoclonal antibodies might obtain an additive~     effect across the stimulation of the antibody dependent cellular cytotoxicity (ADCC)activity.~      The present clinical assay proposes to study the feasibility, safety and effectiveness of~     treatment with autologous effector cells expanded ex vivo associated with a standard~     maintenance treatment with rituximab in patients with follicular lymphoma in remission after~     first-line treatment. In addition, we plan to analyse various biological parameters that can~     predict the susceptibility of patients to treatment with rituximab. Specifically, we propose~     to study the polymorphisms of Fc receptor, polymorphisms related to the ability of complement~     activation, to study both the complement activity and peripheral blood cell subpopulations~     that can mediate directly or indirectly dependent antibody cytotoxic effect. We will also try~     to correlate any of these biological parameters with the response to treatment.~   "
170831|NCT01329341|"~     The purpose of this study is to evaluate use of service dogs for individuals who have been~     diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the~     impact service dogs have on the mental health and quality of life of Veterans; (2) to provide~     recommendations to the VA to serve as guidance in providing service dogs to Veterans; and (3)~     To determine cost associated with total health care utilization and mental health care~     utilization among Veterans with PTSD.~   "
170832|NCT01329328|"~     The aim of this study is to evaluate the effect of whole-body vibration in the presence or~     absence of localized radiofrequency on body composition in obese female subjects. Moreover,~     balance and strength tests will be performed. The study hypothesis is that whole-body~     vibration induces positive changes in body composition i.e., reduction of fat mass and~     increase of lean mass with associated increase in performance. The possible additive role of~     radiofrequency will also be assessed.~   "
170833|NCT01329315|"~     This study examines the impact of tailored computer-delivered and therapist-delivered brief~     motivations prevention/interventions both for adolescents who have not initiated marijuana~     use (prevention), and those who use marijuana (intervention). Key moderators of~     prevention/intervention effectiveness will be examined, including behavioral intentions,~     self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and~     potential health consequences such as STD/HIV risk behaviors. This project will provide the~     critical first step toward the development and implementation of marijuana use~     prevention/intervention programs that have the potential to be delivered to a large segment~     of youth who seek care in our nation's primary care settings.~   "
170834|NCT01329302|"~     The object of this study is to determine the benefit of follicular flushing with a double~     channel needle in a poor responder population for a maximum number of oocytes to be~     retrieved. The investigators compare two methods of oocyte retrieval with or without~     flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm~     Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and~     more the day of ovulation induction will be included, following a randomized protocol in two~     groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G.~     Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all~     follicles are flushed with flushing solution in addition to direct aspiration of the~     follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing~     medium is collected separately from direct fluid aspiration in order to follow up each oocyte~     one by one. First criterion of our comparison is the number of oocyte retrieved. Second~     criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained,~     clinical pregnancy rate. In Group B the investigators will compare two subgroups: oocytes~     collected in flush medium and oocytes from direct follicle fluid. Then the investigators will~     know the capability of oocyte collected after follicular flushing to be fertilized and to~     increase the success chance of pregnancy for poor responder patients.~   "
170835|NCT01329289|"~     The purpose of this study is to determine if adding SOM230 LAR to bortezomib and~     dexamethasone is better than bortezomib and dexamethasone alone and if it should be~     investigated further.~   "
170836|NCT01329276|"~     Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very~     sensitive to detect small changes, it might be worthwhile to study the acute effect of~     formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper~     airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this~     technique makes it possible to detect changes in airway caliber in early stages. The regional~     distribution of resistance and the change in this parameter will provide more insight into~     the mode of action of the product.~   "
170837|NCT01329263|"~     This study will examine how menthol affects smoking when menthol smokers switch to~     non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel~     Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given~     Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days~     each. Participants will provide breath and urine samples, track cigarette usage and complete~     smoking topography assessments of smoking behavior.~   "
170838|NCT01329250|"~     The main objective of this prospective clinical trial is to compare pharmacokinetics and~     safety and tolerability of a standard dose (400 mg) with an escalated dose (600 mg; 800 mg)~     of moxifloxacin (MFX). This clinical trial will provide important safety information on MFX~     in a higher dosage in TB patients.~   "
170839|NCT01329237|"~     The purpose of the study is to compare strut coverage and neointimal thickness between~     everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14~     months after stent implantation and to determine the coronary endothelial function after~     everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14~     months after stent implantation by using supine bicycle exercise testing to assess coronary~     vasomotor response to exercise.~   "
170840|NCT01329224|"~     The purpose of this study is to investigate the incidence of acetylsalicylic acid resistance~     (ASA-R) among patients under chronic acetylsalicylic acid(ASA) treatment seen at our~     outpatient clinic.~   "
170841|NCT01329211|"~     The project will involve conducting a Needs Assessment for Gastroparesis patients and their~     caregivers with the goal of identifying quality of life issues associated with this disease.~     Identifying these issues will ameliorate management and support systems for gastroparesis~     currently existent in the community and, hopefully, provide information for the establishment~     of more resources to assist the patients and their families.~   "
170842|NCT01329198|"~     The purpose of this trial is to determine whether a particular type of Deep Brain Stimulation~     (DBS), scheduled Deep Brain stimulation (SBS), is an effective and safe treatment for~     Tourettte syndrome (TS).~      The trial will also examine the brain activity associated with TS and tics and explore the~     possibility of responsive brain stimulation (RBS).~   "
170843|NCT01329185|"~     The aim of our study is to reduce viral (CMV and EBV) transmission from donor to recipient.~     The discovery that anti-retroviral therapy to mothers with HIV reduced transmission of the~     virus to their babies was pivotal to the prevention of AIDS and so along the same lines the~     investigators will test the hypothesis that 14 days of the anti-viral Valganciclovir (VAL) to~     kidney donors prior to the transplant compared to placebo will reduce EBV and CMV viremia in~     the 1st year posttransplant in pediatric kidney recipients.~   "
170844|NCT01329172|"~     Background :~      Cystic fibrosis (CF) patients are prone to recurrent pulmonary infection have different~     secreted mucin pattern from healthy subjects. Long chain polyunsaturated fatty acids have~     been shown to influence survival and MUC5B expression in mice model of chronic pulmonary~     infection.~      Method :~      To study the impact of LCPUFA n-3 on MUC5B expression (mRNA level by RT-PCR) collected in~     airway epithelial cells obtained by nasal brushing. The secondary aim is to assess : MUC1,~     MUC2, MUC4, MUC5AC, MUC7 expression (mRNA level) in airway epithelial cells obtained by nasal~     brushing; Lund-Kennedy score; TNK-alpha, IL-6, IL-8 in blood plasma. This study is a double~     parallel, controlled double blind, randomized clinical trial : LCPUFA n-3 (1 g/day) vs~     placebo for 6 weeks. 30 subjects will be included in this study. Primary and secondary study~     end point will be assessed two times: before randomization and after 60 days of treatment.~      Statistical analysis :~      Treatment group and placebo will be compared using U-Mann-Whitney, intention to treat and per~     protocol.~   "
170845|NCT01329159|"~     The aim of this study is to assess in the sample of population resident in the KHUMBU valley~     (NEPAL):~        1. the respiratory function decline by means of spirometry and the respiratory health by~          means of questionnaire and six-minute walking distance~        2. the presence of markers of early atherosclerosis with ultrasound and to estimate the~          value of systolic pulmonary pressure in comparison with not exposed subjects.~      The investigators hypothesize that the chronic exposure to indoor pollution~        1. can accelerate the physiological respiratory function decline, usually around~          15-20mL/year in healthy subjects~        2. induce cardiovascular impairment~           The population of high altitude villages is a unique sample to study the effect of the~          only indoor pollution. In fact, the absence of traffic, due to the lack of roads, and~          the very low level of smoking habits allow to have no other confounding factors~        3. to study and analyze how the architectural features of the buildings of the village~          (distribution of domestic locals, natural or non natural ventilation systems, domestic~          activities, materials used, etc.) affect the indoor pollution from carbon monoxide,~          which necessarily is developed indoor during the daily life activities.~      What the project prospects is to gather information focused on the scale of the building,~     independently from the typology, to study a model that will help to describe which aspects~     are most important to what concern the genesis of the pollution of the indoor air.~   "
170846|NCT01329146|"~     Background: calculation of the pulse pressure variation (PPV) has repeatedly been shown to be~     a reliable predictor of fluid responsiveness in mechanically ventilated patients. But PPV~     measurement has not been yet validated in thoracic surgery during one-lung ventilation. The~     modifications of intrathoracic pressure induced by one-lung ventilation may altered the~     capabilities of PPV to predict fluid responsiveness.This study was designed to assess the~     ability of PPV predict fluid responsiveness during one-lung ventilation in thoracic surgery.~      Methods: a prospective observational study. Thirty five patients undergoing a pulmonary~     resection (lobectomy or pneumonectomy) will be included to achieve around one hundred fluid~     challenges with a 250 milliliters colloid solution in response to hemodynamic~     instability.Hemodynamic instability is defined as a decrease by 20 % of artery pressure from~     baseline and/or an increase by 20% heart rate from baseline. Fluid responsiveness is defined~     as an increase in stroke volume index (SVI)>10% (measured with oesophageal doppler). PPV will~     be calculated from recorded artery pressure curve (PPVref) before and after each fluid~     challenge. An automated measurement of PPV proposed by the monitor Intelview (Philips) will~     be recorded simultaneously before and after each fluid challenge.~      Statistical analysis: receiver operating characteristic curve will be used to assess the PPV~     capability to predict fluid responsiveness. Correlation analysis will be achieved using a~     Pearson test or Spearman's rho test when necessary. Continuous data will compared using a~     Student t test or a Mann-Whitney test when necessary.~   "
170847|NCT01329133|"~     Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition, which is~     classically treated by antidepressant medications in combination with psychotherapies.~     However, both these conventional therapeutic approaches fail to sufficiently improve~     obsessive-compulsive symptoms in 20-30% of cases. From these considerations, deep brain~     stimulation (DBS), as a reversible and adjustable surgical procedure, has recently been~     introduced in the field of resistant OCD. DBS currently uses electrodes with four contacts on~     each lead, which are bilaterally implanted into the chosen brain structure. DBS consists of~     the delivery of a high-frequency current through the quadripolar electrodes connected to a~     battery powered pulse-generating device. Several clinical investigations have shown that DBS,~     primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN), as~     brain sites of interest because of their particular involvement in the production of OCD~     symptoms, is able to produce an approximately 40% or greater reduction in clinical symptom~     intensity in severely chronic and incapacitating forms of OCD. These promising findings lead~     to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the~     VS or STN as brain target by conducting a large controlled trial and including a~     medico-economic analysis for assessing the classical cost/efficacy ratio. In this way, the~     present study is expected to promote and highlight the importance of DBS, as an effective,~     safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.~   "
170848|NCT01329120|"~     A large number of institutions have reported their early results with minimally invasive~     repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed~     the outcomes relevant to the concerns of the patients and even fewer have reported long-term~     results following bar removal. Even fewer studies have investigated the prevalence and~     characteristics of long term persistent post-surgical pain following surgical repair of~     pectus deformities. The reasons as to why acute postoperative pain in some patients persists~     and becomes chronic whereas in others the pain dies down shortly after wound healing are~     largely unknown, and why some patients complain of loss of sensibility in wide regions of~     their chest following surgery also remains unclear.~   "
170849|NCT01329107|"~     The incidence of bladder cancer is increasing. Denmark have approximately 1800 incidence per~     year. The disease is most frequently in males above the age of 70 years. In invasive~     bladdercancer surgery including removal of the seak bladder with constructing of a new~     diversion, is the first line treatment. However the procedure is followed by a high morbidity~     and convalescence. Extended surgical procedure cause pain, stress-induced metabolism and~     impaired organ function resulting in postoperative complications impacting on rehabilitation.~     The combination of extended surgery and the increasing numbers of elderly comorbid patients~     with invasive bladder cancer challenge professional treatment and care~      The aim of the study is to investigate the efficacy of a multiprofessional rehabilitation~     programme for patients with invasive bladder cancer referred to surgery~      Material and Methods The study is a randomised controlled trial. All patients > 18 years~     referred to radical cystectomy will be eligible for this study. The efficacy is primary~     expressed by the difference in length of stay(LOS). Secondly by complications, health related~     quality of life(HRQoL) and patient reported quality of care during hospitalization. The~     intervention includes precise instructions and educations in intensive pre- and~     postoperatively exercises and stoma-care, supported by the multiprofessional team.~      Perspective It is a national goal to improve cancer care. This study is of critical~     importance and places great emphasis on the patients perspective and involvement in a~     successful outcome for participant`s and involvement in nutritional support, intensive~     exercises and stoma care, supported by the multidisciplinary team~   "
170850|NCT01329094|"~     The aim of the study was to evaluate the applicability of the Physical Activity Scale (PAS)~     in relation to patients with severe mental illness. The study hypothesised that physical~     activity levels among patients with severe mental illness was significantly lower than~     healthy controls. The physical activity level of patients with severe mental illness~     attending Aarhus University Hospital, Risskov in comparisons with healthy controls matched on~     gender and age was assessed with PAS.~   "
170851|NCT01329081|"~     BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in~     Denmark. The results after TKA is in general very good, the investigators have, however,~     discovered that patients following fast-track TKA still have a deficit 12 months~     postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and~     participation when compared to age- and gender matched population. A postoperative~     rehabilitation intervention has the potential to reduce or remove this observed deficit. The~     current evidence of postoperative rehabilitation after TKA is, however, scares and~     conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively.~      PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative rehabilitation~     intervention is more effective than supervised home training, and furthermore to investigate~     the cost-effectiveness of the intervention in a societal perspective.~      MATERIALS & METHODS The study is performed as a randomized clinical trial. In total 140~     patients are included in the study. Inclusion criteria are age above 18 years, patients~     diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients who~     are able to and willing transport themselves to the rehabilitation center, which demands~     ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental~     or revision arthroplasty, any neurological disease, knee infection, and substantial pain or~     functional limitation hindering rehabilitation tested by physiotherapist prior to~     rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome~     measure is change in total score by using the knee specific questionnaire Oxford Knee Score.~   "
170861|NCT01328951|"~     This double-blind, placebo-controlled study will evaluate the benefit of first-line~     maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in~     participants with advanced NSCLC who have not progressed following 4 cycles of platinum~     based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor~     (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150~     milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will~     receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on~     erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will~     continue until disease progression, death, or unacceptable toxicity. Participants may also be~     entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.~   "
170852|NCT01329068|"~     Carriers of a BRCA mutation have a significantly increased risk to develop breast cancer in~     the course of their lives . They face a difficult choice: either a preventive removal of the~     breast(s) or an intensive inspection process.~      After primary treatment of breast cancer, patients will be followed for 5-10 years to~     diagnose recurrence or a new primary tumor in an early stage; to support the patient during~     hormonal treatment; to educate the patient about risk factors and healthy life style; and to~     provide psychosocial support.~      Currently, follow-up of breast cancer patients and surveillance of BRCA mutation carriers is~     offered in regular, one-to-one medical visits. Experience shows that in an individual visit~     it is often not possible to give all aspects that are important, enough attention. The group~     medical consultation (GMC) is a new form of medical visits where the physician or nurse~     practitioner performs a series of one-to-one consultations in the presence of 8 to10 other~     patients. A social worker accompanies this process. Patients in group consultations may~     gather more information because they learn from each other and there is relatively more time~     compared to a regular consultation. Research shows that both patients and caregivers are more~     satisfied with care after a group consultation compared to individual visits. After a GMC the~     participants from the breast cancer GMCs will be provided with a dedicated iPad for 3 months.~     Using this iPad, patients can contact the women they have met during the GMC as well as~     health care professionals by several communication channels, including virtual group~     meetings. This approach provides a unique combination of both social support and professional~     education concerning survivorship in an e-health environment.However, it is also known that~     group sessions may be counterproductive for some patients, for example because they are~     frightened by the stories of others. The goal of this study is to examine whether group~     visits (in combination with dedicated iPads) are beneficial to women with a BRCA mutation and~     for patients in follow-up after breast cancer.~   "
170853|NCT01329055|"~     Previous studies of the patients treated in RRI clinics suggest that hemodialysis patients~     undergo a certain consistent predictable pattern at the initiation of dialysis and before~     death. This pattern can be described as a group of patterns of patients' biological markers~     over a few months after starting dialysis and several months prior to death. Additional~     patterns can be observed that occur with changes in seasons or time of day. The aim of this~     study is to compare these patterns in patients treated in FMC-Asia, FMC-Europe, FMC-South~     America, and RRI-US populations. Noting that patterns in patient parameters are similar~     across continents, climates, and geographic variations only further accentuates the~     importance in the models that can predict patients' survival and provide an opportunity for~     timely intervention.~   "
170854|NCT01329042|"~     Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become~     the therapy of choice for renal stone. Although providing good results, stone recurrence is~     usually found as the therapies do not change the underlying metabolic abnormality. Among the~     metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis.~     This study evaluate the preventive effects of potassium sodium citrate on stone recurrence as~     well as stone growth post ESWL or PCNL, in patients with calcium-containing stones.~   "
170855|NCT01329029|"~     The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets~     once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who~     are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and~     inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of~     roflumilast will be obtained. An additional objective is to further characterize the~     population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further~     characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of~     efficacy and relevant safety aspects.~      Patients to be included are required to have severe COPD associated with chronic bronchitis~     and a history of frequent exacerbations and must be concomitantly treated with a fixed~     combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and~     placebo) are included.~   "
170856|NCT01329016|"~     This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and~     combination treatment for gestational diabetes mellitus.~   "
170857|NCT01329003|"~     Silicosis is well-known occupational disease caused by free crystalline silica (silicon~     dioxide) and is marked by inflammation and pulmonary fibrosis. There are cumulative evidences~     that exposure to Caesar stone (quartz surface products that manufactured from up to 93%~     quartz, polymer resins and pigments) is particularly dangerous to exposed workers.~      Goals: To examine correlation between disease and exposure to Caesar stone and genetic~     differences regarding genes involved in oxidative stress to understand Genetic susceptibility~   "
170858|NCT01328990|"~     The aim of the study is to determine the pharmacokinetic profile of sulfadoxine-pyrimethamine~     plus amodiaquine (SP+AQ) when used for seasonal Intermittent Preventive Treatment (IPT) to~     prevent malaria in children aged 3 to 59 months in Lamarame, NDoffane District, Senegal.~     Several studies have shown that seasonal IPT in children can provide a high degree of~     protection against clinical malaria. SP+AQ is the most effective regimen. However little is~     known about the pharmacokinetics of amodiaquine and sulfadoxine-pyrimethamine in children.~     The purpose of this study is to determine the pharmacokinetics profile of SP+AQ when used for~     IPT in Senegalese children. 150 children aged 3 to 59 months will be enrolled in November.~     They will receive a therapeutic dose of sulfadoxine-pyrimethamine and amodiaquine, and will~     be followed up for 30 days. Four finger prick blood samples will be taken from each child for~     PK analysis.~   "
170859|NCT01328977|"~     This study attempted to identify the best method for educating and engaging academic~     physicians in grateful patient philanthropy.~   "
170860|NCT01328964|"~     The objective of this study is to compare asthma-related exacerbations (emergency department~     (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that~     received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast~     (MON). This retrospective observational cohort analysis utilizes a large managed care~     database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or~     BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index)~     with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously~     eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index.~     Dose of each inhaled corticosteroid was not known in the database. Follow-up was defined for~     each patient as the period beginning with the index date and ending with the last date of~     continuous claims history, switch to another asthma controller medication, or claim for an~     asthma related event (ED/IP visit or OCS use) post-index, whichever occurred first.~   "
170911|NCT01328262|"~     The aim of this study is to evaluate whether the targeted hemoglobin increment (2 grams per~     decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag~     transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the~     control group, the prescribed number of red cell units will be transfused.~      Hypothesis: By matching the hemoglobin dose to the individual needs of the patient the~     investigators will reduce the total usage of red cell concentrates.~   "
170862|NCT01328938|"~     This study is adaptive design and it consists of stage I and stage II.~      Stage I is multi-center, parallel-group, single-blind, phase II study to determine the~     adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will~     be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.~      Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the~     efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to~     Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate~     into this phase.~   "
170863|NCT01328925|"~     The purpose of this study is to determine the effectiveness of nitazoxanide suspension~     compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of~     age.~   "
170864|NCT01328912|"~     Remote ischemic preconditioning (RIPC) occurs when a tissue (ex. heart) becomes less~     vulnerable to an ischemic insult if a remote tissue (ex. arm) has had previous exposure to a~     period of ischemia and reperfusion. A beneficial effect of RIPC has been demonstrated in~     several randomized studies in patients undergoing cardiac and vascular surgery, as well as~     interventional cardiac procedures such as angioplasty. They have shown improvements in~     cardiac, renal, neurologic and respiratory function. Most have focused on surrogate outcomes,~     such as biochemical markers of cardiac and renal function in low-risk patients. No trials~     have investigated only high-risk patients or been designed to detect clinical outcomes.~      This study is a randomized-controlled trial powered to detect clinical events in a high-risk~     cohort undergoing cardiovascular surgery. Patients will be randomized to RIPC (exposed to~     cycles of inflation of a blood pressure cuff on the upper arm prior to undergoing surgery) or~     control (no ischemic stimulus).~      The investigators hypothesize this population will demonstrate lower rates of adverse~     ischemic events. The investigators also intend to sample biochemical markers to better~     elucidate the mechanism of RIPC and generate hypotheses for future studies and interventions.~     Post-operatively the investigators will monitor for adverse clinical outcomes including~     cardiac, renal, pulmonary and neurologic injury.~      RIPC is simple, inexpensive and easily reproducible and there have been no reports of adverse~     consequences. Post-operative ischemic events such as stroke, myocardial infarction, cardiac,~     renal and respiratory failure affect patient survival and quality of life, and represent a~     sizeable financial burden to health care. If beneficial effects of RIPC are demonstrated, it~     will be widely applicable to the entire population of cardiac and vascular patients resulting~     in a widely-implemented change in practice.~   "
170865|NCT01328899|"~     This is a multicenter single arm open label study. The primary objective is to evaluate the~     safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of~     patients with emphysema in multiple centers.~   "
170866|NCT01328886|"~     The purpose of this extension study is to assess the long-term safety and tolerability of~     omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with~     inadequately controlled allergic asthma despite current recommended treatment by providing~     continued treatment with omalizumab to patients who have previously completed the core study.~   "
170867|NCT01328873|"~     Pulmonary infiltrates frequently complicate the care of hematopoietic stem cell transplant~     (HSCT) and leukemia patients. Bronchoalveolar lavage (BAL) is frequently used to evaluate new~     pulmonary infiltrates in this population, however utility is limited by a historically low~     diagnostic yield for infection.~      In an effort to improve diagnostic yields, this study will complete a Fiberoptic Bronchoscopy~     (FOB) within 8 hours of radiographic documentation of pulmonary infiltrates, prior to~     initiating new antibiotic therapy. To further improve detection of microbiological pathogens,~     the study will utilize PCR testing with rapid turnaround time to detect atypical pneumonia (M~     pneumoniae, C. Pneumonia, Legionella species, and respiratory viruses) and aspergillosis.~   "
170868|NCT01328860|"~     The purpose of this research study is:~        1. To see if Bone Marrow Cell harvest and transplantation are safe in children with Spinal~          Cord Injury, and~        2. To determine if late functional outcome is improved following Bone Marrow Cell~          transplantation in children with Spinal Cord Injury, using pre-transplantation spinal~          cord function as the control.~   "
170869|NCT01328834|"~     This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release~     Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).~   "
170870|NCT01328821|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     CTP-499 following single dose administration.~   "
170871|NCT01328808|"~     The purpose of this study is to investigate how acetaminophen (APAP) is released into the~     urine and blood; to determine how the blood levels of acetaminophen and its breakdown~     products affect the preterm infant's health; to decrease adverse drug reactions; and to~     collect data on how the genetic make-up or characteristics affect how APAP is handled within~     the preterm infant. By taking several blood and urine samples during the study, we will be~     able to check the blood levels (called pharmacokinetics) of APAP in preterm babies.~   "
170872|NCT01328795|"~     Aims of the study:~      Patients in a Chest Pain Unit (CPU) are examined to clarify if the cause of pain is cardiac~     or not. To identify patients with ST-elevation and other electrocardiogram (ECG)~     modifications a normal 12-lead ECG is used. The diagnosis non-st-elevation myocardial~     infarction is determined with the help of the ischemic marker Troponin. However, Troponin~     levels are elevated earliest 3 to 4 hours after the ischemic event, so that a negative~     Troponin result at the time of hospital admission is insufficient. Thus the guidelines of the~     German Society of Cardiology demand a second measurement after 6 to 12 hours. In rare cases~     false positive Troponin levels have been reported (e.g. in patients with renal~     insufficiency).~      The aim of this study is to determine if in the early phase of diagnostic assessment~     cardiogoniometry can improve differentiation between patients with cardiac (ischemic)~     emergency and patients with non-cardiac (non-ischemic) cause of pain. Furthermore it will be~     evaluated if cardiogoniometry is capable to diagnose patients with non-ST-elevation~     myocardial infarction (NSTEMI) to the same extent as Troponin. This could avoid time loss~     until a possibly necessary catheter intervention (fast track).~      To clarify these questions the result of the cardiogoniometry will be compared with the~     leading diagnosis of the Chest Pain Unit, the diagnosis at hospital discharge as well as with~     the angiographic findings (as a gold standard). Therefore the performance of cardiac~     catheterization within 72 hours after start of symptoms is a mandatory inclusion criterion.~   "
170905|NCT01328366|"~     The impact of psoriasis on an individual's emotional and social well-being goes beyond skin~     symptoms of the disease. Data suggests patients with severe psoriasis experience a greater~     prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal ideation.~     Given the nature of the disease and the treatment failures which are required before a~     patient commences a biologic therapy such as adalimumab, the patient's mental health at~     initiation of biologics is an important consideration for clinicians. This study seeks to~     explore if adalimumab treatment of psoriasis leads to a positive impact on psychosocial~     factors and disease-related quality of life.~   "
170873|NCT01328782|"~     The goal of this study is to compare different ways of treating pain after surgery. This~     research study involves subjects who have a supracondylar elbow fracture and need surgery.~     This type of fracture occurs when the humerus (upper arm bone) is broken just above the~     elbow. Like any other surgery, you can expect that you will feel pain in the hours or days~     after the operation. Currently, despite the common occurrence of this surgery, there is not a~     standard way to treat and or prevent any of the pain afterwards.~      At this hospital, oral (take by mouth) pain medicine is commonly used to treat pain after~     this surgery.~      In this study, pain will be treated in one of the following ways:~        1. with oral pain medication~        2. with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of~          bupivacaine (a numbing drug) or~        3. with oral pain medicine and an intraarticular shot of ropivacaine (another numbing~          drug). The shots will be given during surgery. Your participation will help us find out~          which of these three pain control methods works the best.~      The correct dosages of all drugs will be safely prescribed by the doctor on an individual~     basis and all drugs will be used under the careful watch of your attending physician. All the~     drugs used this study are approved by the FDA for use in adults but they are not specifically~     approved for use in children. However, nearly 7 out of every 10 drugs approved for adults are~     not specifically approved by the FDA for use in children. All drugs used in this study will~     be used in a way that is considered to be safe and reasonable by the Children's Hospital.~   "
170874|NCT01328769|"~     In this study the investigators will recruit hypertensive subjects with higher than average~     uric acid levels to test the effect of lowering uric acid with febuxostat on several measures~     as listed below. This will be a randomized, double-blind, placebo-controlled, parallel group~     study.~   "
170875|NCT01328756|"~     While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy,~     safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and~     adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have~     been of short duration - up to 8 weeks.~      A number of long-term studies have been undertaken (up to 1 year) and these have confirmed~     the safety and ongoing efficacy in this patient population.~      In order to run a study with investigational medication within Poland the study changed to a~     Phase 3 rather than a Phase 4 study in that country. Please note that the study number~     remains as SPD489-404.~      Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in~     children and adolescents over a 2-year treatment period.~   "
170876|NCT01328743|"~     This is a randomized clinical trial to examine the effects of a brief counseling intervention~     for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. The~     study tests the hypothesis that brief counseling will lower drinking in these patients and~     that reductions in drinking will be associated with better HIV-related outcomes.~   "
170877|NCT01328730|"~     Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating~     patients with coronary artery disease (CAD). The efficacy and safety of Cypher SES (Cordis,~     MA) has been proved by several randomized clinical trials. Here the investigators design a~     prospective, multicenter, randomized clinical study in purpose of identifying the~     non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES~     (Microport, Shanghai), comparing with Cypher SES.~   "
170878|NCT01328717|"~     Subjects with diabetes and study staff used an investigational blood glucose monitoring~     system.~   "
170879|NCT01328704|"~     The purpose of this study is to observe changes in iron status and vitamin D status during a~     12-24 week supervised training program, specifically males and females between the ages of 30~     and 50 years old.~   "
170880|NCT01328691|"~     Renal cell carcinoma (RCC) has its propensity to invade the venous system, with extension~     into the renal vein and the inferior vena cava (IVC) in 23% and 7%, respectively. Despite~     advances in radiation, chemotherapy, and immunotherapy the reference standard for RCC with~     tumor thrombus remains surgical resection. However, the 5-year survival rate for patients who~     have RCC with venous tumor thrombus treated with radical nephrectomy and tumor thrombectomy~     is only 35% - 45%, despite the developments in surgical technique and perioperative care.~     Furthermore, even the 5-year survival rate for the patients without the evidence of nodal or~     distant metastasis at presentation is just 45% - 65%.~      The outcome prediction for RCC remains controversial, and although many parameters have been~     tested for prognostic significance, only a few have achieved widespread acceptance in~     clinical practice. Currently, pathologic stage (T stage), lymph node status (N stage) and~     histologic grade represent the main prognostic variables in the patients with RCC and venous~     tumor thrombus. Accordingly, the American Joint Committee on Cancer (AJCC) TNM classification~     is regularly revised and, recently, a new 2009 AJCC TNM stage classification system has been~     proposed.~      RCC is more prevalent in developed countries, such as Europe and North America. It is~     relatively less common in Asia; however, the incidence in these regions appears to have risen~     over the past decade. Recently, a few series have suggested that racial or ethnic differences~     in survival persist after controlling for age and stage in some cancers. In the case of renal~     cell carcinoma, it has been demonstrated that the malignancy diagnosed in various ethnic~     groups had different clinical characteristics: the presenting symptoms, the course of~     disease, and the outcome after standard treatment varied significantly between patients of~     Caucasian, Hispanic, African-American, and Asian backgrounds. A recent study has reported~     that race as well as established factors has an impact on survival in patients with RCC and~     Asian Pacific Islander ethnicity was predictive of improved overall or cancer specific~     survival.~      Up to date, there was sparse data on surgical outcome and prognostic factors of survival~     after radical nephrectomy and thrombectomy in an Asian population with RCC and venous tumor~     thrombus, while most studies have been performed in Western countries. The aim of the present~     study was to address the surgical outcome after radical nephrectomy with thrombectomy and to~     evaluate the prognostic factors influencing on survival in Korean patients with RCC and tumor~     thrombus extension into renal vein or IVC, labeled as T3a and T3b-c by the newly revised 2009~     AJCC TNM staging system, respectively.~   "
170881|NCT01328678|"~     The objective of this study is to assess the parathyroid-vitamin D-calcium axis in subjects~     with alopecia areata. The hypothesis behind this study is that hypovitaminosis D might~     contribute to the pathogenesis of alopecia areata.~   "
170882|NCT01328665|"~     This project evaluates the effectiveness of an intervention sought to reduce the physical~     effects of stress related to those issues that individuals cannot successfully communicate~     with anyone about. To do this, the investigators will be implementing a writing intervention~     over the course of the 6-week study. The investigators will be asking all participants to~     complete questionnaires over the course of the study period. The investigators are also~     asking participants to provide a small blood sample (from a fingerstick procedure) at two~     times during the study as well as saliva samples during that same time. The primary research~     question asks if this intervention procedure is effective. The investigators are evaluating~     total cholesterol, high sensitivity c-reactive protein, and cortisol.~   "
170906|NCT01328353|"~     The overall objective of this study is to evaluate the effectiveness of a telehealth care~     coordination and case management nursing intervention for children with complex special~     health care needs.~   "
170883|NCT01328652|"~     Main Hypothesis: The investigators hypothesize that measurements of lingual tonsil tissue~     (LTT) thickness will decrease following treatment with once daily oral dexlansoprazole 60 mg~     in patients diagnosed with laryngopharyngeal reflux (LPR) and lingual tonsil hypertrophy~     (LTH) compared to matched controls receiving placebo.~      Primary endpoints include:~        -  24-hour oropharyngeal pH testing, pre- and post-treatment~        -  Mean lingual tonsil tissue (LTT) thickness, pre- and post-treatment, as determined by CT~          scan of the base of tongue~      Secondary endpoints include:~        -  Reflux Finding Score (RFS) on pre- and post-treatment endoscopy of the oropharynx~        -  Subjective outcome metrics for assessing LPR-related symptoms and associated quality of~          life~        -  Calgary Sleep Apnea Quality of Life Index~        -  Bed-partner assessment of snoring intensity according to a Visual Analog Scale~        -  Epworth Sleepiness Scale (ESS)~        -  Reflux Symptom Index (RSI)~      Specific Aims: The primary objective of this study is to determine whether treatment of~     patients diagnosed with LPR and LTH with 3 months of PPI therapy reduces LTT thickness, as~     measured on CT scan of the tongue base.~      The secondary objectives of this study are to:~        -  Evaluate changes in LPR-related symptoms and quality of life after therapy using the~          following subjective outcome metrics:~             -  Calgary Sleep Apnea Quality of Life Index~             -  Bed-partner assessment of snoring intensity according to a Visual Analog Scale~             -  Epworth Sleepiness Scale~             -  Reflux symptom index~        -  Correlate changes in LTT thickness with the following secondary endpoints:~             -  Changes in the above subjective outcome metrics~             -  Changes in endoscopic findings of LPR~             -  Changes in 24-hour oropharyngeal pH study results~   "
170884|NCT01328639|"~     Background & Objective: Type 2 diabetes is a complex disease characterized by multiple~     comorbidities. Depression is one of the most common comorbidities in individuals with~     diabetes with prevalence rates reaching 30%. Depression complicates diabetes treatment,~     portends worse outcomes and increases health care costs. One novel approach to managing~     diabetes with co-morbid depression is a collaborative primary care model involving a~     multidisciplinary health care team guiding patient-centered care. This model has been tested~     in the US and showed a significant reduction of depressive symptoms, improved diabetes care~     and patient-reported outcomes, and saved money. Our aim is to evaluate the implementation of~     this collaborative care model for type 2 diabetes and comorbid depression within the~     non-metro Primary Care Network (PCN) setting in Canada.~      Intervention: The intervention involves three phases: (1) improving depressive symptoms, (2)~     improving blood sugar, blood pressure and cholesterol, and (3) improving lifestyle~     behaviours. The intervention is administered by a CM in collaboration with family physicians,~     psychiatrists, and internists.~      Hypotheses: The TeamCare-PCN intervention will reduce depressive symptoms, achieve targets~     for cardio-metabolic measures and improve lifestyle behaviours. Furthermore, the~     investigators anticipate this intervention will be acceptable and implemented in a~     cost-effective manner in the PCN environment.~      Methods: The investigators will employ a mixed-methods approach to our evaluation, using a~     controlled on-off trial design. Our primary analysis will be based on a multivariable~     scaled marginal model for the combined outcome of depressive symptoms and medical care.~     Secondary analyses will assess changes in lifestyle behaviours and patient-reported outcomes.~      Significance: Our work will serve as a platform upon which an emerging model of primary care~     can incorporate an effective and cost-effective depression intervention into the management~     of individuals with type 2 diabetes, and as a framework for implementing and evaluating~     similar interventions in individuals with other chronic conditions.~   "
170885|NCT01328626|"~     This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of~     ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation:~     Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately~     116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll~     approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were enrolled~     in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose escalation~     portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the~     MTD. Once the MTD is declared for the arm, approximately 60 additional CLL/SLL subjects in~     Arm A and approximately 20 additional DLBCL subjects and 20 additional follicular lymphoma~     subjects in Arm B will be enrolled in an expanded safety portion of the study at the~     recommended phase 2 dose (RPTD) and schedule.~   "
170886|NCT01328613|"~     Background:~      - Postpartum depression (PPD) is a serious syndrome that resembles a major depressive episode~     and occurs in 10% to 20% of all mothers in the year following delivery. Women with histories~     of major depressive disorder (MDD) are at an increased risk for PPD and recurrent PPD with~     subsequent pregnancies. One possible genetic vulnerability to depression and PPD in~     particular is the BDNF gene. BDNF is a protein that affects the growth and development of~     brain cells, including those that help to regulate mood. BDNF levels have been shown to be~     significantly lower in individuals with depression, including women. Researchers are~     interested in studying BDNF levels and hormones such as estrogen in pregnant women who have~     MDD and are at risk for developing PPD.~      Objectives:~      - To study connections between the BDNF protein and hormonal levels in pregnant women who are~     at risk for developing postpartum depression.~      Eligibility:~      - Women who are currently pregnant and have a history of major depressive disorder, and~     either are taking a selective serotonin reuptake inhibitor (SSRI) or are not taking an~     antidepressant.~      Design:~        -  This study involves six visits over the course of 12 months, during the first, second,~          and third trimesters (if possible) as well as 1 week, 1 month, and 3 months postpartum.~          Women will be allowed to participate at any point during pregnancy, but researchers are~          most interested in recruiting women who are in the first trimester.~        -  Participants will be screened with a physical examination and medical history, blood~          samples, and questionnaires about their history of depressive episodes.~        -  At each visit, participants will complete a number of questionnaires on depression~          symptoms, such as sleep disturbance and stress levels. Participants will also provide~          blood samples for hormone and other testing.~        -  Participants who become depressed during the study will be referred to a treating~          psychiatrist or other professional for appropriate care and treatment.~   "
170887|NCT01328600|"~     Background:~        -  Preeclampsia is a combination of high blood pressure and other potentially~          life-threatening symptoms. Preeclampsia occurs in up to 10% of pregnancies and is a main~          cause of maternal and fetal death worldwide. Treatment is often difficult, and so far~          there is no specific and effective therapy. Researchers have been studying the body~          systems that regulate blood pressure. They have also studied drugs that can control~          certain blood chemicals that constrict blood vessels and increase blood pressure.~        -  DIGIBIND, a drug that lowers blood pressure, has been used to treat pre-eclampsia.~          Marinobufagenin (MBG), a chemical in the blood that constricts blood vessels, has been~          shown to be involved in pre-eclampsia. But researchers are still not certain whether~          DIGIBIND can be used to specifically target MBG. Researchers want to find out whether~          DIGIBIND acts against MBG specifically. This information may help them to develop better~          drugs to block MBG and lower blood pressure in women with preeclampsia.~      Objectives:~      - To study whether the blood pressure treatment drug DIGIBIND specifically acts on~     marinobufagenin levels in the blood of pregnant women.~      Eligibility:~      - Women between 18 and 50 years of age who are 34 to 39 weeks pregnant and have preeclampsia.~      Design:~        -  Participants will be screened with a physical examination, medical history, and blood~          and urine tests.~        -  Before delivery, participants will provide blood samples for testing and evaluation.~        -  Following delivery, participants will provide additional blood samples and samples of~          the placenta for testing and evaluation.~        -  No additional treatment, apart from the standard of care, will be provided as part of~          this protocol.~   "
170907|NCT01328340|"~     We are exploring a unique weight-training program for men and women 55 years or older with~     knee osteoarthritis (OA) that emphasizes high-speed movements. We believe that the speed at~     which muscles move may be more important to the improvement of muscle performance, function~     and pain than how strong the muscles are. We are comparing high-speed power training with~     traditional strength training to determine which method has the greatest effects on muscle~     strength, muscle power, speed of movement, functional performance and pain. We believe that~     high-speed training will improve these measures to a greater extent than simply training for~     increased muscle strength.~   "
170912|NCT01328249|"~     The purpose of this study is to assess the feasibility of dose-dense doxorubicin and~     cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast~     cancer.~   "
170888|NCT01328587|"~     Background:~        -  Moderate aplastic anemia is a blood disease which may require frequent blood and~          platelet transfusions. Sometimes patients with this disease can be treated with~          immunosuppressive drugs. Not all patients respond and not all patients are suitable for~          this treatment.~        -  Thrombopoietin (TPO) is a protein made by the body. The bone marrow needs TPO to produce~          platelets. TPO may also be able to stimulate bone marrow stem cells to produce red cells~          and white cells. However, TPO cannot be given by mouth. This has led researchers to~          develop the drug eltrombopag, which acts in the same way and can be given by mouth.~          Eltrombopag has been shown to safely increase platelet numbers in healthy volunteers and~          in patients with other chronic blood diseases, including severe aplastic anemia.~          Researchers are interested in looking at whether eltrombopag can be given to people with~          moderate aplastic anemia and significantly low blood cell counts.~      Objectives:~      - To evaluate the safety and effectiveness of eltrombopag in people with moderate aplastic~     anemia or patients with bone marrow failure and unilineage cytopeniawho need treatment for~     significantly low blood cell counts.~      Eligibility:~      - People at least 2 years of age who have moderate aplastic anemia or bone marrow failure and~     unilineage cytopenia,and significantly low blood cell counts.~      Design:~        -  Patients will be screened with a physical examination, medical history, blood tests, a~          bone marrow biopsy, and an eye exam.~        -  Patients will receive eltrombopag by mouth once a day.~        -  Patients will have weekly blood tests to monitor the effectiveness of the treatment and~          adjust the dose in response to possible side effects.~        -  Patients may continue to take eltrombopag if their platelet count or hemoglobin~          increases, their requirement for platelet or blood transfusion decreases after 16 to 20~          weeks of treatment, and there have been no serious side effects. Access to the drug will~          continue until the study is closed. Patients will be asked to return for a follow-up~          visit 6 months after the last dose of medication.~   "
170889|NCT01328574|"~     Background:~      - Urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis) often responds~     initially to standard chemotherapy treatments, but frequently recurs and can often spread to~     other parts of the body. TRC105, an experimental drug that blocks the development of the new~     blood vessels needed for tumor growth, may be able to shrink or stabilize urothelial cancer~     tumors. TRC105 has been given previously to individuals with other types of cancer, and~     researchers are interested in determining its safety and effectiveness in treating urothelial~     cancer.~      Objectives:~      - To determine the safety and effectiveness of TRC105 as a treatment for metastatic~     urothelial cancer that has not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with urothelial cancer that~     has spread to other parts of the body and has not responded to standard chemotherapy.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          and tumor imaging studies.~        -  Participants will receive TRC105 intravenously once every 2 weeks on days 1 and 15 of a~          28-day treatment cycle. The first dose of TRC105 will be given over a 4-hour period;~          participants who do not have side effects may receive the next dose over 2 hours. If the~          second dose is tolerated, subsequent doses can be given over at least 1 hour.~        -  To help prevent known side effects of TRC105, participants will take two doses (one in~          the morning and one in the evening) of the steroid dexamethasone on the day before each~          infusion is scheduled. Participants may have additional dexamethasone 30 minutes before~          infusion, and may have the infusion slowed or stopped to adjust for side effects.~        -  Participants will be monitored with blood samples, physical examinations, and tumor~          imaging studies through the cycles of treatment.~        -  Participants will continue to take TRC105 for as long as the treatment is effective~          against the cancer and as long as the side effects are not severe enough to stop~          treatment.~   "
170890|NCT01328561|"~     Background:~      - Oxytocin, a substance produced mostly in the brain, plays a role in influencing social~     interactions and reactions to stress, and may be related to pain. Arginine vasopressin, a~     hormone that regulates water, sugar, and salt in the blood, influences hostile behaviors and~     reactions to stress, and may also be related to pain. Researchers are interested in~     investigating both substances and their relationship to pain in healthy volunteers.~      Objectives:~      - To evaluate the effects of oxytocin and arginine vasopressin on pain in healthy volunteers.~      Eligibility:~      - Healthy volunteers between 18 and 55 years of age.~      Design:~        -  This study involves two 2-hour testing sessions held 1 day apart. Each session includes~          the administration of oxytocin, arginine vasopressin, or placebo (a nonactive~          substance), or no drug. The drugs and the placebo will be given by a nasal spray.~        -  At the first visit, participants will provide blood and saliva samples to measure~          hormone levels, and will be asked to fill out questionnaires about some psychological~          factors such as anxiety and empathy. Participants will then have an assessment of their~          sensitivity to pain, consisting of a brief electrical stimulation that lasts less than 1~          second. After the pain assessment, participants will receive oxytocin, arginine~          vasopressin, placebo, or no drug at all, and will be monitored to provide baseline~          information. Participants will then have another pain sensitivity test and will complete~          the questionnaires again, and provide another saliva sample.~        -  At the second visit, participants will provide another saliva sample; receive oxytocin,~          arginine vasopressin, placebo, or no drug at all; and have tests of pain sensitivity and~          a pain-relieving procedure. During the pain-relieving procedure, participants will~          receive brief, moderately painful electrical shocks on the back of the nondominant hand~          and a low-level electrical stimulation on the middle finger that counteracts or reduces~          the pain from the shocks. Participants will rate their pain perception at the end of~          each stimulation by using a visual scale ranging from 0 (no pain) to 10 (maximum~          imaginable pain). The experiment ends with a final saliva collection and completion of~          the psychological questionnaires.~   "
170891|NCT01328548|"~     This study is being done to evaluate the zoster vaccine response in the nursing home elderly~     (80 years or older). As the immune system ages, the response to vaccines is not always as~     strong as in younger people. Previous zoster vaccine studies have excluded nursing home~     residents so the vaccine effect in this population is not known. Furthermore, the immune and~     genetic reasons as to why the vaccine works well in some people but not in others are also~     unknown. The goal of this study is to evaluate why some immune systems respond well to the~     vaccine and why others do not.~   "
170892|NCT01328535|"~     This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage~     IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving TMZ at different times, which are determined individually~     for each patient based on the phase (biorhythm) of the immune system response against the~     tumor may allow for a better drug response and may kill more tumor cells~   "
170893|NCT01328522|"~     Primary Objective:~      Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after~     a single dose administration in rheumatoid arthritis patients.~      Secondary Objective:~      Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products~     after a single dose administration in rheumatoid arthritis patients.~   "
170894|NCT01328509|"~     The purpose of the proposed project is to investigate measures of zinc status in relation to~     oxidative stress and inflammation in patients with sepsis. We hypothesise that zinc depletion~     can modulate inflammatory responses, leading to increased oxidative stress and mitochondrial~     dysfunction.~      Sepsis is a severe infection is the leading cause of death in critically ill patients [1].~     Zinc deficiency impairs overall immune function and resistance to infection [2]. In vitro~     exposure of monocytes to lipopolysaccharide (LPS) leads to decreased cellular zinc content~     [3] and zinc redistribution has been shown in human volunteers in response to LPS [4]. Zinc~     depletion occurs in hospitalized patients including those with infections, the elderly,~     alcoholics, trauma or burns [5-8], conditions which are common among critically ill patients~     with sepsis. In a mouse model of sepsis, zinc depletion prior to sepsis resulted in more~     inflammation and more severe organ injury and increased mortality [9]. In patients with~     sepsis, early feeding with zinc resulted in faster recovery of organ function compared with~     control [10]. Zinc status is likely to be compromised in the critically ill and that zinc~     depletion may affect inflammatory responses and recovery.~      Although zinc is not an antioxidant itself, it binds to metallothionein [11] and zinc~     supplementation decreases oxidative stress [12]. Oxidative stress has been consistently~     reported in patients with sepsis [13-15]. We have recently shown that protection of~     mitochondrial function with antioxidants can reduce organ damage in rats [16]. Pentraxin-3 is~     an inflammatory marker which is regulated in part by antioxidants and plays a key role in~     innate immunity [17].~      The consequences of zinc deficiency may relate, in part, to its effects on nuclear factor~     NFκB, a transcription factor crucial to the signalling networks involved in sepsis [18].~     Higher NFκB activity is associated with increased mortality in patients with sepsis [19,20].~     It is likely that compromised antioxidant defences and inflammation occurs as a consequence~     of zinc deficiency.~      We propose to measure plasma zinc and metallothionein mRNA status in relation to inflammatory~     markers including key cytokines, pentraxin-3, markers of oxidative stress and antioxidant~     status in patients with sepsis.~   "
170908|NCT01328301|"~     This study aimed to explore whether speed-dependent treadmill training is more effective at~     improving walking and balance performance than speed-stable treadmill training in patients~     with subacute stroke. Twenty-six patients with stroke completed 2 weeks of treadmill~     training. Results showed that speed-dependent treadmill training is more effective at~     improving walking speed and step length than speed-stable treadmill training in patients with~     subacute stroke.~   "
170895|NCT01328496|"~     In this study, participants with high-risk hematologic malignancies undergoing hematopoietic~     cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched~     related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin~     receptors (KIR) ligand mismatched haploidentical donor identified, will receive an umbilical~     cord blood transplantation (UCBT) using a myeloablative preparative regimen.~      The preparative regimen includes fludarabine (75 mg/m2), fractionated total body irradiation~     (TBI) (10.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a~     day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy~     for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at~     60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with~     cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF~     will start on day +1.~   "
170896|NCT01328483|"~     The purpose of the study is to evaluate the role of routine suctioning of the oropharynx~     before the delivery of shoulders in preventing breathing difficulty and subsequent lung~     disease in babies born through meconium stained amniotic fluid. Normally babies do not pass~     meconium while in utero. In response to hypoxic stress babies may pass meconium before birth~     and are likely to be candidates for problems related to meconium passage and its inhalation~     leading to meconium aspiration syndrome(MAS). It is believed that clearing the airways of~     meconium at the time of birth can decrease the risk of MAS. It had been a routine practice to~     suction the mouth, pharynx and nose of the baby as soon as the head of the infant is~     delivered prior to delivery of the shoulders followed by tracheal intubation and suction in~     babies with poor breathing efforts to clear the airways of the meconium. however recent~     studies have shown the futility of this procedure in preventing MAS along with an increased~     risk of complications to baby due to suctioning. In view of the uncertainty regarding the~     effectiveness of this procedure in a resource poor country, the investigators decided to~     evaluate the effect of intrapartum-oropharyngeal suction in preventing or decreasing the~     incidence of MAS in such babies.~   "
170897|NCT01328470|"~     Impaired renal function is associated with reduced responsiveness to clopidogrel. There are~     no studies which have shown a means by which to overcome platelet hyporesponsiveness in~     patients with chronic kidney disease (CKD). The purpose of this study was to determine the~     functional impact of cilostazol in patients with CKD undergoing hemodialysis.~   "
170898|NCT01328457|"~     The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients~     with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days~     after treatment begins), and at 6 months after end of treatment (Day 202/203, -15 to +30~     days).~   "
170899|NCT01328444|"~     This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination~     and component, two-period, incomplete block design cross-over study using GSK573719/GW642444.~     The primary objective is to evaluate lung function and exercise endurance time after 12 weeks~     of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and~     62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25~     mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI)~   "
170900|NCT01328431|"~     This study will test the effectiveness of an Emergency Department (ED) initiated tobacco~     intervention which includes counseling and medication. Our proposed intervention combines a~     Brief Negotiated Interview (BNI) with initiation of nicotine patch and gum in the ED, as well~     as a faxed referral to the state's Smokers' Quitline. A 6 week supply of nicotine patches and~     nicotine gum are provided to subjects in the intervention arm. Subjects randomized to the~     control arm will receive a brochure from the state's Smokers' Quitline only.~      The primary hypothesis is that the intervention will be superior to the control condition in~     reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months.~   "
170901|NCT01328418|"~     The purpose of this study is to determine whether lengthening of both the tibiae and femora~     in achondroplastic patients is safe and provides reproducible outcome.~   "
170902|NCT01328405|"~     Introduction:~      The air-QⓇ Intubating Laryngeal Airway (ILA) is a newer supraglottic airway. It is approved~     for use as a primary airway and as an aid for intubation in situations of anticipated or~     unanticipated difficult airways. A unique feature of this device as compared to other airways~     on the market is the size of the inner diameter (ID) and length of its airway tube. Direct~     placement of tracheal tubes > 7.5 mm ID through the airway tube is possible.~      The ProSealTM LMA is considered the gold standard for supraglottic devices with respect to~     airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is~     significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a~     maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice.~      In this study the investigators aim to test whether the air-QⓇ creates an airway seal~     pressure that is similar to the LMA-ProSealTM, whether the position of the air-QⓇ in relation~     to the vocal cords, as assessed by fiberoptic endoscopy, is similar to that of the~     LMA-ProSealTM and whether airway morbidity is similar between the air-QⓇ and the~     LMA-ProSealTM.~   "
170903|NCT01328392|"~     Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in~     symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system~     which measures liquid reflux in the esophagus. The investigators are evaluating a new 24-hour~     pharyngeal pH monitoring system by Restech which can measure acid exposure in the airway and~     can be used specifically for LPR diagnosis. The purpose of this study is to determine whether~     the Restech device is more effective than standard pH monitoring in predicting the response~     to proton pump inhibitor (PPI) acid suppression therapy using Dexlansoprazole in patients~     with symptoms and/or manifestations of LPR.~   "
170904|NCT01328379|"~     The purpose of this study is to investigate the safety and efficacy of a lower dose of~     dalfampridine extended release tablets compared to the currently approved dose in improving~     walking in Multiple Sclerosis (MS) patients.~   "
170909|NCT01328288|"~     The purpose of this study is to study the HIV disease progression in HIV-infected Thai~     children.~   "
170910|NCT01328275|"~     The purpose of this study is to study the HIV disease progression in HIV-infected Thai Adult.~   "
170924|NCT01328093|"~     The purpose of this study is to determine whether weight gain will be significantly less in~     LY2140023 than aripiprazole in patients with schizophrenia.~   "
170913|NCT01328236|"~     Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage~     therapy for Multiple Myeloma (MM).~      The present study is designed to assessment the efficacy and safety study of Bortezomib in~     combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia~     (PCL).~      Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is~     the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of~     response (DOR), overall survival (OS).~   "
170914|NCT01328223|"~     Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients~     present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency~     ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a~     curative treatment and have achieved very limited success in eradicating large HCC. With the~     development of new radiotherapy (RT) technique, RT can be more safely given to patients with~     larger tumor burden. Thus, TACE combined with RT has been suggested for treating large HCC.~     Based on the results of these studies, RT could achieve a tumor response rate of 50 % to 70~     %. However, it has not been definitively shown to prolong the overall or disease-free~     survival due to lack of a phase III clinical trial. In contrast, a retrospective clinical~     investigation with molecular study suggests that sublethal dose of RT promoted HCC growth~     outside RT field.~      Two phase III trials were shown to be efficacious and well-tolerated in patients with~     advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib~     group than that in the placebo. It is interesting to recognize the combined therapeutic~     effect of RT with sorafenib. Based on several preclinical experiments, tumor angiogenesis~     inhibitors seem to be synergistic with irradiation when using before RT, concurrently with~     RT, or after RT. Thus, the investigators design a single-arm phase II clinical trial to~     investigate the efficacy of combined RT with sorafenib.~      The eligibility criteria are patients with unresectable HCC; good performance status; no~     prior radiotherapy for the liver; clinical measurable tumor; good liver function and good~     compliance. After entering this study, the testee will receive RT to hepatic tumor with~     concurrently sorafenib with a dose of 400 mg twice daily. Hepatic RT will be performed with a~     daily fraction size of 2.0 to 2.5 Gy to a total dose of 46 Gy to 60 Gy. After RT, maintenance~     sorafenib with a dose of 400 mg twice daily will be ongoing. Sorafenib will be continued~     until the occurrence of clinical or radiologic progression, or the occurrence of either~     unacceptable adverse events or death. Minimum maintenance duration of 6 months is~     recommended, but not mandatory.~   "
170915|NCT01328210|"~     Metabolic syndrome (MS) has an increasing prevalence worldwide and there is an urgent need~     for improvement of medical treatment. In traditional medicine phlebotomy (blood letting) is a~     recommended treatment for subjects with obesity and vascular disease. Recent studies showed~     that blood letting with iron depletion may improve insulin sensitivity in patients with~     diabetes mellitus. The investigators aimed to test if traditional blood letting has~     beneficial effects in patients with MS. A randomized trial with a sample size of 64~     self-referred MS patients was conducted. Patients in the blood letting group were allocated~     to blood letting intervention and the control group was offered a later treatment (waiting~     list). In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after~     4 weeks. Primary outcomes were the change of systolic blood pressure and of insulin~     sensitivity as measured by HOMA-Index.~   "
170916|NCT01328197|"~     The primary goal of the study is to assess the safety and performance of the Treovance device~     in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased~     pathology can be treated with an acceptable adverse event rate and that the device performs~     as expected. The results of this study will permit the establishment of endpoints and~     clinical design for a subsequent U.S. trial.~   "
170917|NCT01328184|"~     The objective of this study is to investigate the possible effect of multiple oral doses of~     25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and~     levonogestrel (LNG) (Microgynon®).~   "
170918|NCT01328171|"~     The aim of the trial is to optimize response rates and rates of secondary resections of~     metastases in patients with initially non-resectable metastatic colorectal cancer of RAS~     wildtype. The patients will be treated in two therapy groups:~      Experimental arm A: Chemotherapy with FOLFOXIRI + panitumumab Standard arm B: Chemotherapy~     with FOLFOXIRI~   "
170919|NCT01328158|"~     This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify~     the following with regard to treatment with this drug:~        1. Incidence and conditions of occurrence of adverse reactions in the clinical setting~        2. Factors that may affect the safety and effectiveness of Kaletra (QD)~   "
170920|NCT01328145|"~     The pathomechanisms of COPD are still not fully understood, and up to now there is no~     satisfying causal treatment inhibiting the progress of the disease. Available therapy is in~     most cases symptomatic. Experimental and clinical observations suggest that treatment with~     ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional~     improvement.~      To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a~     prospective, randomized, double-blind, placebo controlled study will be conducted. Adult male~     and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2 groups~     (i.e. 37 patients per group, stratification according to smoking status and gender). They~     will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary efficacy~     endpoints are changes in the lung-functional parameter FEV1 (forced expiratory 1-second~     volume) after 12 weeks of treatment. Secondary endpoints are the health score of the St.~     Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).~   "
170921|NCT01328132|"~     The primary aim of this study is to assess the effect of hyperoncotic albumin on vascular~     hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to~     try to identify the dominant physiological mechanism so that we will be able to better~     identify patients that may benefit from the use of albumin (25%) boluses in addition to~     standard care in patients following liver transplantation.~   "
170922|NCT01328119|"~     Rationale: The mortality of end-stage renal disease (ESRD) patients on dialysis remains high.~     This may at least be partly due to the insufficient removal of (especially protein-bound)~     uremic toxins which have been associated with cardiovascular morbidity and mortality. It is~     unknown whether the combination of long-hour haemodialysis (HD) with convection increases the~     removal of these toxins. Long-hour HD and long-hour haemodiafiltration (HDF) may also improve~     haemodynamic stability which is an important factor in treatment quality. The investigators~     aim to study the removal of uremic toxins in long-hour HD and HDF and to compare the~     haemodynamics between 4-hour and 8-hour HD and HDF.~      Objectives: The primary aim is to study the removal of (especially protein-bound) uremic~     toxins in 4-hour and 8-hour HD and HDF. A secondary aim is to compare the haemodynamic~     response between 4-hour and 8-hour HD and HDF.~   "
170923|NCT01328106|"~     The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an~     effective and safe treatment for cancer subjects with metastatic uveal melanoma and~     mutation-positive GNAQ or GNA11 metastatic melanoma.~   "
170926|NCT01328067|"~     The objective of this trial is to evaluate the safety and efficacy of ExAblate for the~     treatment of uterine fibroids.~      Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the~     study.Women who agree to participate will sign an informed consent and will be randomized to~     ExAblate treatment or myomectomy.~      All patients will be followed through the 36 month visit. Follow-up visits/telephone calls~     will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post~     treatment.~      Patients will be evaluated by assessing their overall physical and mental health as well as~     for device/procedure related adverse events.~   "
170927|NCT01328054|"~     This study will estimate the effect of lapatinib on cardiac repolarization (QTc interval~     duration) in subjects with advanced solid tumors. The study treatment period will occur over~     five days and an End of Study visit will be conducted on Day 8 (or no later than 3 days~     beyond Day 8). Subjects will receive placebo that mimics lapatinib for 2 days as three~     separate doses given 12 hours apart (8 tablets/dose) and lapatinib (2000mg) for 2 days as~     three separate doses given 12 hours apart (8 tablets/dose). Subjects will not know when they~     are receiving placebo vs. lapatinib. Digital 12-lead ECG recordings will be extracted from~     continuous ECG recordings obtained via a Holter monitor to measure QTc interval duration.~     Triplicate ECG measurements of QTc interval will be taken at pre-specified times at Day 1~     (Baseline) and pre-dose and up to 24 hours after the third dose of placebo or lapatinib on~     Study Days 2 and 4. Pharmacokinetic sampling will occur immediately following each~     pre-specified QTc measurement in subjects dosed with placebo or lapatinib. Subjects who~     complete participation in this study, if they are eligible, will be offered the option to~     continue treatment with lapatinib, either alone or in combination with other oncology drugs~     in pre-selected anticancer regimens, in a continuation protocol, EGF111767.~   "
170928|NCT01328041|"~     The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir~     (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults~     with current or historical failure on an integrase inhibitor (INI) containing regimen. The~     study will assess DTG 50mg twice daily administered initially with the current failing ART~     regimen but then with an optimised background ART regimen (OBR) after Day 7. The first~     analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects~     may remain on study after Week 24.~   "
170929|NCT01328028|"~     The aim of this study is to assess the distribution of the most frequent types of human~     papillomavirus in women diagnosed with invasive cervical cancer in New Zealand.~   "
170930|NCT01328015|"~     A study in which the experimental treatment procedure is compared to a standard (control)~     treatment, The use of oxybutynin in the late postoperative thoracic sympathectomy for women:~        1. To Evaluate the effect of oxybutynin on plantar hyperhidrosis.~        2. To evaluate the effect of oxybutynin in compensatory hyperhidrosis.~        3. To compare the results of questionnaires on quality of life and specific for~          hyperhidrosis to the results of TEWL.~   "
170931|NCT01328002|"~     The purpose of this study is to evaluate the safety, tolerability, efficacy, and~     pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary~     fibromyalgia.~   "
170932|NCT01327989|"~     The objective of this study was to obtain prospective clinical data on the safety and~     efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.~   "
170933|NCT01327976|"~     The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro~     Rechargeable System compared to a sham control for the treatment obesity. The Maestro~     Rechargeable System delivers intermittent, electrical blocking signals to the anterior and~     posterior trunks of the intra-abdominal vagus nerve (termed vBloc Therapy) and is designed to~     reduce sensations of hunger and produce satiety leading to weight loss. After approval from~     the institutional review board, subjects provided written consent and were randomized in a 2~     to 1 allocation to vBloc group (with laparoscopic placement of the leads and neuroregulator)~     or the sham group (placement of a custom sham neuroregulator only) on double-blinded basis.~     Both groups received similar diet and exercise counseling. Weight, adverse events, clinical~     laboratories, ECGs, eating questionnaires and quality of life data were evaluated throughout~     the 12 month study duration.~   "
170934|NCT01327963|"~     The purpose of this open-label, postmarket study is to evaluate the safety and efficacy of~     transoral incisionless fundoplication (TIF) performed with EsophyX in a broad range of~     gastroesophageal reflux disease (GERD) patients treated at high volume centers across the~     United States.~   "
170935|NCT01327950|"~     This is a national, prospective, multi-center, non-randomized study to evaluate the long-term~     efficacy and integrity of the EPICTM Nitinol Vascular Stent System in Superficial Femoral~     Artery (SFA) lesions. A total of 100 patients will be included in approximately 10 sites. The~     study is designed to demonstrate the EPIC Nitinol Vascular Stent System is non- inferior to~     the published patency rates found in the literature. This non-inferiority will be established~     by proving that the true rate for the EPICTM Nitinol Vascular Stent System is higher than 82%~     minus a 10% delta.~   "
170936|NCT01327937|"~     The overall study objective is to use microarray technology to identify and characterize the~     gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.~   "
170937|NCT01327924|"~     This study is conducted in Europe. The purpose of this study is to assess the impact on daily~     life for children new to using a growth hormone injection device.~   "
170938|NCT01327911|"~     This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate~     the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.~   "
170939|NCT01327898|"~     The specific aims of the 5-year study are to: 1) describe the nature and extent of substance~     use and sexual risk behaviors in a sample of 500 sexually active, substance using,~     not-in-treatment men who have sex with men (MSM) in urban South Florida (Miami/Ft.~     Lauderdale); 2) identify the independent covariates of baseline substance abuse and sexual~     risks; 3) evaluate, through random assignment of participants, the relative effectiveness of~     two intervention conditions in reducing sexual risks and substance use, as measured at 3-,~     6-, and 12-month follow-up assessments: a) an innovative five-session risk reduction~     intervention derived from psychological empowerment theory titled Project GOAL; and, b) an~     enhanced community standard-of-care HIV counseling Comparison Condition.~   "
170940|NCT01327885|"~     This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and~     safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have~     disease progression within 6 months prior to study enrolment following standard therapies~     which must have included an anthracycline, unless contraindicated and then at least one~     additional regimen after failure of the anthracycline.~   "
170941|NCT01327872|"~     This will be a randomized, open-label, four-group, two-period, replicate design study to~     evaluate the effect of food on within and between subject variability in second generation~     formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single~     doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a~     reduction in either the within or between subject variability (coefficient of variation~     [CV]%) of approximately 35%.~   "
170942|NCT01327859|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil~     (Aricept) in Parkinson's Disease (PD) patients with dementia.~   "
170943|NCT01327846|"~     Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial is to test the~     hypothesis that canakinumab treatment of patients with MI at least one month prior to study~     entry and elevated hsCRP will prevent recurrent cardiovascular events.~      The purpose of the extension phase of the main study is to collect additional long-term~     safety data on continued exposure to canakinumab in patients who participated in the pivotal~     phase.~      Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study is to evaluate the effect of~     quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the~     carotid plaque burden measured by integrated vascular MRI in patients enrolled in the~     CACZ885M2301 study (CANTOS).~      Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study is to determine whether,~     in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared~     to placebo, on top of standard of care increases insulin secretion and insulin sensitivity.~   "
170944|NCT01327833|"~     The purpose of this study is based on method Utstein, registering all recommended items of~     that model, in addition to adding more information, characterizing this way using a template~     Utstein modified for the epidemiology of PCR-hospital in Brazil.~      Objectives: establish a registry of patients suffering from respiratory (PCR)-hospital to~     assess demographic and clinical variables such as morbidity, mortality and standard practice~     in cardiopulmonary resuscitation (CPR). In addition, assess independent predictors associated~     with survival in several times and survival curves.~   "
170945|NCT01327820|"~     To define any changes in whole body oxygen consumption that occur following major vascular~     surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and~     infra-inguinal lower limb revascularisation procedures).~   "
170946|NCT01327807|"~     Cure Cystinosis International Registry (CCIR) is an online, patient self-identifying registry~     developed by medical and scientific experts specifically for the cystinosis community.~      CCIR's sole purpose is to identify people with cystinosis worldwide in an effort to~     accelerate novel treatments and a cure for cystinosis.~      CCIR provides a safe and secure platform for:~        -  sharing anonymous medical information about cystinosis with researchers, clinicians and~          patients~        -  disseminating information about research opportunities~        -  connecting researchers/investigators and prospective participants *~      Interested cystinosis patients may register themselves with CCIR online at~     http://www.cystinosisregistry.org.~      * No personal information is shared outside of CCIR. Individual identities are known only to~     appropriate CCIR staff. If a participant is matched to a clinical trial, the participant~     receives a notice from CCIR, after which they can decide whether they wish to contact the~     study sponsor.~   "
170947|NCT01327794|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how well patients will respond to treatment.~      PURPOSE: This research trial is studying the relationship between vitamin D biomarkers and~     survival in blood samples from patients with advanced pancreatic cancer.~   "
170948|NCT01327781|"~     This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in~     treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to~     other places in the body (metastatic) or has come back at or near the same place as the~     original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells.~     Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use~     of estrogen by tumor cells.~   "
170949|NCT01327768|"~     Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1~     to 2 months before transplantation. The Olfactory Ensheathing Cells (OECs) will be cultured~     and expanded under the rule of GTP. Then, quality control of OECs should be done by~     immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators~     will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area~     of the brain.~   "
170950|NCT01327755|"~     Study Hypothesis: The addition of selenium supplementation to cotrimoxazole will improve CD4~     counts, decrease opportunistic infections, decrease viral loads and delay the need for~     initiating antiretroviral therapy(ART) in Rwandan adult patients infected with HIV/ AIDS.~   "
170951|NCT01327742|"~     This study is a continuation of the pivotal trial studying the safety and efficacy of the~     Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being~     evaluated by the device-related adverse event rate of endovascular repair (via the Relay~     thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse~     events through 1 year in subjects treated with the Relay thoracic stent-graft to those who~     underwent surgical repair.~   "
170952|NCT01327729|"~     The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated~     interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and~     with no prior treatment for hepatitis C virus (HCV).~      Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)~   "
170953|NCT01327703|"~     This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000~     compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis~     (CF) and exocrine pancreatic insufficiency (EPI).~   "
171368|NCT01322256|"~     The investigators' primary objective is to assess the predictive power of PET/CT scanning in~     the evolution of infectious osteoarthritis of the diabetic diabetic after antibiotic therapy~     prescribed by national and international recommendations.~   "
170955|NCT01327677|"~     This research is being done to compare two methods of giving fentanyl, a narcotic often given~     to patients following brain surgery and determine if one method has more side effects than~     the other. Both of these methods are available in the postoperative treatment of pain. This~     research also is being done to determine if patients receiving narcotic pain medicine will~     benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines~     can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide~     levels will help identify a slower breathing rate and improve safety.~   "
170956|NCT01327664|"~     This study will provide patients who have completed the AIN457 Phase II and Phase III~     clinical trials in non-infectious uveitis continued access to treatment with AIN457 while~     collecting safety data and information on long term clinical use of treatment with AIN457.~   "
170957|NCT01327651|"~     Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of~     antiretroviral (ARV) medications before exposure to HIV. This study will examine the~     feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will~     be compared: daily, time-based, and event-based.~   "
170958|NCT01327638|"~     The study is intended to provide additional post-marketing safety data regarding the use of~     etoricoxib for the indication of ankylosing spondylitis.~   "
170959|NCT01327625|"~     [Study Objectives]~        -  To evaluate the efficacy of azithromycin, N-acetylcystein, and inhaled corticosteroid~          combination therapy in patients with bronchiolitis obliterans as a complication of~          allogeneic hematopoietic cell transplantation in terms of response rate at 6 months~          after treatment initiation based on the improvement of FEV1.~   "
170960|NCT01327612|"~     The purpose of this protocol is to allow continued treatment with conatumumab and/or AMG 479,~     with or without chemotherapy to subjects without disease progression whose previous studies~     were closed.~   "
170961|NCT01327599|"~     The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV®~     from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle~     glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).~   "
170962|NCT01327586|"~     Randomized clinical trial comparing a money management-based intervention involving storage~     and management of client funds, substance abuse counseling, and risk reduction counseling to~     individualized drug counseling.~   "
170963|NCT01327573|"~     This study is designed to assess the effectiveness of eculizumab in recipients of kidney~     transplantation with donor-specific antibodies (DSA) and worsening kidney function and to~     assess if eculizumab improves endothelial cell injury in the kidney.~      The investigators hypothesize that complement inhibition with eculizumab will reduce~     allograft injury, resulting from less complement-mediated injury of endothelial cells and~     less endothelial cell activation.~   "
170964|NCT01327560|"~     Sleep quality is an important predictor of healthy status,quality of life and life span.~     Sleeping problems affect 50%~80% in hemodialysis patients. Sleep quality and related factors~     research in hemodialysis patients has been discussed and studied globally. Previous studies~     show insomnia, excessive daytime sleepiness(EDS), sleep apnea syndrome(SAS), restless legs~     syndrome(RLS) are major causes of poor sleep quality . There is few data to show the~     influential factors related to sleep quality in Taiwanese hemodialysis patients.~   "
170965|NCT01327547|"~     To describe liver enzyme elevations in patients who are coinfected with HIV and either~     Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with~     their current suppressive anti-HIV drug therapy.~   "
170966|NCT01327534|"~     Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary~     arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted~     myocardium.~   "
170967|NCT01327521|"~     Primary Objective:~      To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent HCC~     after initial TACE.~      Secondary Objectives:~        1. To determine the progression-free survival of TACE vs. CyberKnife SBRT~        2. To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC~        3. To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of~          recurrent HCC.~   "
170968|NCT01327508|"~     The objective of this study is to quantitate the amount of radiation both subjects and~     surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT~     Distal Targeting System versus Standard nailing instrumentation.~   "
170969|NCT01327495|"~     The investigators will conduct a three-month, randomized, placebo-controlled trial comparing~     the effects of increasing doses of androgen supplementation with Testosterone (T) gel on the~     prostate in healthy men who are treated with acyline to block gonadal androgen production.~   "
170970|NCT01327482|"~     This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the~     female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug~     levels to prevent viral integration of HIV-1. The study will also assess whether drug levels~     change in the tissue across the different phases of the menstrual cycle.~        -  Hypothesis #1: Twice daily dosing with raltegravir 400mg will result in intracellular~          concentrations that should be sufficient to suppress HIV-1 replication throughout the~          menstrual cycle.~        -  Hypothesis #2: Intracellular genital raltegravir peaks will be lower and troughs higher~          compared to extracellular concentrations in the plasma and PMBCs (peripheral blood~          mononuclear cells).~        -  Hypothesis #3: Intracellular raltegravir concentrations will be slightly lower during~          the luteal phase of the menstrual cycle due to cellular pumps such as p-glycoprotein,~          which are present in higher numbers during periods of high progesterone.~   "
170983|NCT01327313|"~     The primary objectives are to assess the safety and tolerability of single and repeated doses~     of EMD525797, and characterize Pharmacokinetics (PK). The secondary objectives are to~     investigate the immunogenicity and Progressive disease (PD), and to assess the anti-tumor~     activity of EMD525797.~   "
170984|NCT01327300|"~     The purpose of this study is to find whether treating patients with diarrhea predominant~     Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help~     improve their symptoms of diarrhea, bloating and abdominal pain.~   "
170985|NCT01327287|"~     This study is designed to analyze the use of early aggressive pain management with thoracic~     epidural in eligible patients with blunt thoracic trauma.~   "
170971|NCT01327469|"~     The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris~     trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the~     most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH~     and more than one billion individuals are thought to be infected, of which 450 million have~     significant morbidity attributable from their infection, school-aged children in particular.~     In this population infections cause stunting of the linear growth, anemia, reduce the~     cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are~     highly prevalent, affecting more than 60% of the children (data not published).~      Current efforts to control STH infections involve periodic mass drug anthelmintic treatment~     of infected children in endemic areas and are likely to intensify as more attention is~     addressed to the importance of these neglected diseases. Monitoring drug efficacy in these~     control programs has become indispensable in order to detect the emergence of resistance~     and/or identify confounding factors affecting the drug efficacy. Recently a study has~     evaluated a single dose albendazole (ALB) in school age children across 7 countries,~     including Ethiopia, revealing that this regime is highly efficacious for the treatment of A.~     lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this~     parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate.~     Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose~     10mg/kg), of which the latter holds promise as it can also be administrated to children~     between 6 months and 2 years. The main objective of the present study, therefore, is to~     assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren~     in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x~     500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).~   "
170972|NCT01327456|"~     Purpose: To determine the role health literacy plays in the care continuum for Chronic~     Obstructive Pulmonary Disease (COPD) and the effect of a self-management intervention on~     inhaler technique use, time spent on self-management, and knowledge for COPD patients with~     low literacy.~      Participants: The investigators will recruit patients from the University of North Carolina~     at Chapel Hill Ambulatory Care Center (ACC) who have a diagnosis of COPD.~      Procedures (methods): Potential subjects with COPD will be identified through pharmacy claims~     data, clinic billing data and the electronic medical record. Eligibility will be prescreened~     by a research assistant (RA) using the electronic medical record prior to approaching~     potential subjects for consent. For the first part of the study, consenting subjects will~     complete a baseline health literacy assessment, a questionnaire, an inhaler technique~     assessment, and a diary of time spent in self-management activities. Pulmonary function tests~     (PFT) will be performed on all participants for whom PFTs have not been conducted within the~     previous 12 months. The questionnaire will include measures of COPD-related knowledge,~     self-management techniques, quality of care, access, quality of life, costs, healthcare~     utilization, exacerbations, and basic demographic information. The inhaler technique~     assessment will be administered by the research assistant using a pre-established protocol.~     The research assistant will abstract additional data from the medical record to assess the~     quality of care based on adherence to recommended COPD care guidelines. For the second part~     of the study, participants will be randomized to control and intervention arms. The~     self-management intervention will be an interactive experience, delivered by a trained~     research assistant, targeting self-management skills (inhaler use, using an action plan,~     etc), smoking cessation, and exercise/pulmonary rehabilitation. Those randomized to the~     control group will receive usual care. All participants will return 2-4 weeks after the~     intervention for a follow-up assessment of inhaler technique, COPD-related knowledge, and~     time spent in self-management.~   "
170973|NCT01327443|"~     The central hypothesis of this proposal is that a reduction in hepatic mitochondrial function~     is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non~     alcoholic steatohepatitis). The investigators further hypothesize that lifestyle~     modifications through aerobic exercise training without weight loss or diet-induced weight~     loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content~     and function in human subjects.~      The investigators propose a randomized, controlled human clinical trial to compare the~     effects of aerobic exercise training (without weight loss) versus diet-induced weight loss~     (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH~   "
170974|NCT01327430|"~     The aim of the study is to investigate parameters of the lipid metabolism in plasma and feces~     of healthy subjects after a dietary supplementation of different dosages of milk~     phospholipids.~   "
170975|NCT01327417|"~     The purpose of the study is to examine the relationship between brain structure and~     depression in adults aged 60 or older. This relationship is determined using magnetic~     resonance imaging technology (MRI), a scanner with a magnet that is used to create images of~     the brain.~   "
170976|NCT01327404|"~     The purpose of the study is to examine the relationship between brain structure and~     depression in adults aged 30 or older with Diabetes. This relationship is determined using~     magnetic resonance imaging technology (MRI), a scanner with a magnet that is used to create~     images of the brain.~   "
170977|NCT01327391|"~     The aim of this study is to appreciate the tolerance of on line hemodiafiltration and its~     impact on morbidity and cardiovascular risk factors in chronic renal failure patient.~   "
170978|NCT01327378|"~     The current study explores the incretin effect; a central mechanism of sugar metabolism.~     People with type 2 diabetes have a markedly reduced incretin effect, while the incretin~     effect never has been studied in patients with severe chronic renal failure. Non-diabetic~     patients with severe kidney failure and patients with diabetes and normal kidney function~     share several pathophysiological traits, including decreased sensitivity to insulin, fasting~     hyperinsulinaemia and impaired beta cell function. The investigators expect the incretin~     effect to be affected in patients with chronic renal failure without diabetes, which in time~     can result in therapeutic changes in this group of patients.~   "
170979|NCT01327365|"~     Background:~      The transradial approach is increasingly used in percutaneous coronary intervention (PCI)~     because of lower major access site complications, lower bleeding risk and earlier patient~     mobilization. According to this trend, in the last couple of years at the University Hospital~     of Geneva the investigators have changed their practice and currently the transradial~     approach is the most frequently used for PCI. However, the small diameter of the radial~     artery remains a major limitation of the technique, especially in women or for complex PCI~     necessitating larger bore guiding catheters. This may be overcome with sheathless guiding~     catheters (Asahi, Japan), allowing for a standard inner catheter diameter (6-7 Fr), with an~     outer diameter equivalent to a standard 5 and 6 Fr introducer sheath.~      Aim:~      This study is aimed to compare the transradial approach for PCI with a sheathless guiding~     catheter and with a standard guiding catheter in women and patients with complex lesion~     necessitating large bore guiding catheters.~      Material and methods:~      This prospective study will consecutively randomize all women and all men with~     bifurcation/ostial lesion of a major coronary vessel (i.e. ≈ 120/year) in whom a transradial~     PCI is attempted. The procedures will be performed either with a standard 6 or 7Fr guiding~     catheter or with the sheathless 6.5, 7.5 Fr catheters.~      End-points:~      Successful performance a transradial PCI in all consecutive patients which qualify according~     to the inclusion criteria (technical feasibility). Establish the proportion of procedures~     performed with no device-related complications (safety). Analyze in details the technical~     aspects of the sheathless catheter (efficacy).~      Sample size:~      The investigators have planed to include in the study ≈ 250 patients in two years. After 1~     year of enrollment the investigators will perform an interim analysis and the instigators~     will decide at that moment, according to the observed end-points, if prolonging the study~     would be of any scientific value. In this case another 100 patients will be further included~     in the study.~      Enrollment time:~      The investigators will start the study as soon the local ethical committee will give us the~     permission. The investigators plan to start the study in July 2010. The end is expected for~     July 2012.~   "
170980|NCT01327352|"~     The study will be a non-randomized, open label, single dose, placebo control, single center,~     and single arm study in healthy subjects. The study will include one administration of~     placebo and four single administrations of Oshadi D in two different dose levels,~     administered in two feeding regimen for the evaluation of the influence of food on Oshadi D~     absorption.~   "
170981|NCT01327339|"~     post-marketing surveillance to monitor safety and efficacy of ropinirole during using of~     treatment for RLS~   "
170986|NCT01327274|"~     This study is a Phase 3, multicenter, non-randomized study to evaluate the safety and~     efficacy of the next-generation outpatient Magnetic Mini-Mover Procedure (3MP) in 15 patients~     aged 8-14 years for the correction of pectus excavatum ('sunken chest'). 3MP for pectus~     excavatum uses a magnetically coupled implant to pull the sternum forward and gradually~     remodel the deformed costal cartilage. The Funding Source for this trial is the FDA Office of~     Orphan Products Development (Grant #R01 FD003341).~   "
170987|NCT01327261|"~     A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and~     benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix~     S.A.I.C. y F., Buenos Aires, Argentina) and a reference formulation (Madopar ®; Roche Pharma,~     Switzerland) to assess their relative bioavailability. After administration of each~     formulation 17 blood samples are taken and levodopa is measured by HPLC. Pharmacokinetic~     parameters (AUC, Tmax and Cmax) are compared.~   "
170988|NCT01327248|"~     The aim of this case-control study is the characterization of the bronchial and systemic~     inflammation of children and young adults with bronchiolitis obliterans.~      On the first visit subjects are asked to perform a lung function test (spirometry, body~     plethysmography with helium). Further levels of eNO and eCO are determined. A blood sample is~     drawn to describe the inflammatory status. Bronchial inflammation will be measured in induced~     sputum. At the second visit, a non-specific bronchial provocation testing (PD20 FEV1~     methacholine) is performed.~   "
170989|NCT01327235|"~     The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin~     alone or Endostar alone in patients with malignant pleural effusion or ascites.~   "
170990|NCT01327222|"~     The purpose of this study is to compare the effectiveness of intravitreal bevacizumab~     injection (IVBI) with respect to simple observation in patients with subfoveal choroidal~     neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at~     baseline with best corrected visual acuity (BCVA) less than 20/200.~   "
170991|NCT01327209|"~     Verify the following with blood glucose monitoring system:~        -  precision and accuracy versus YSI reference~        -  user evaluation~        -  labeling comprehension~   "
170992|NCT01327196|"~     The objective of this project is to study cognitive yields in people of the town of Salamanca~     over 65, with particular emphasis on the acquisition of the initial symptoms of cognitive~     impairment in order to detect mild cognitive impairment and study the relationship between~     the clinical situation and cardiovascular risk factors. It will depart from a reference~     population of 420 people older than 65 years living in the municipality of Salamanca which~     took part in a survey prior to partner health needs of the elderly of 65 years in the~     municipality of Salamanca. This was a stratified sampling as stratum considering the area of~     health. The results of this study are expected to evidence the extent of the problem of~     cognitive decline in the population over 65 years. It is also expected to determine the~     relationship between the co-morbidity in this problem and specific factors of cardiovascular~     risk in this group of population.~   "
170993|NCT01327183|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety~     of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing~     percutaneous coronary intervention (PCI). Patients will be randomized to receive an~     intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI.~     Follow-up will be for 4 months.~   "
170994|NCT01327170|"~     The aim of this study was to evaluate safety and therapeutic response to micropulse diode~     810nm laser treatment in patients with chronic central serous chorioretinopathy.~   "
170995|NCT01327157|"~     -  The purpose of this study was to evaluate the effects of Neuro Occlusal Rehabilitation~          (RNO) in patients with peripheral facial palsy (PFP) disease, noting the decrease in~          symptoms of masticatory dysfunction.~        -  According to Carvalho (2009) patients with PFP have chronic unilateral masticatory~          preference. Santos et al. (2009) in the same year noted that these conditions can lead~          to problems with temporomandibular disorder.~        -  Hypothesis- known that performing occlusal adjustment in these patients with chronic~          PFP, ensuring a maximum of dental contacts and a final stop of the masticatory cycle~          stable, providing a balanced occlusion.~        -  dental cleaning was performed in two groups for the blind study~        -  visual analog scale -To assess the quality of the oral functions of these patients, the~          investigators applied the visual analog scale(VAS) and statistically evaluated the~          degree of satisfaction regarding the functions of oro facial in relation to mastication~          and temporomandibular dysfunction.~        -  gnathostats models were made in the treatment group in the first and last query~        -  occlusal adjustment in treatment group.In the group treated occlusal adjustment was made~          in the teeth and applied a new (VAS) before and after treatment.~      The RNO, is defined as a part of medicine that operates in stomatology occlusal plane as a~     guide to a harmonious development of the face, chewing facilitating bilateral and~     alternating. (Planas, 1997). It works through selective grinding on the occlusal platform,~     providing an increased number of dental contacts.~   "
170996|NCT01327144|"~     Herpes Zoster is an infection that affects part of the nervous system caused by Varicella~     Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often~     associated with significant pain.~      There are effective oral prescription antiviral medicines available to reduce the discomfort~     of symptoms as famciclovir and aciclovir.~      This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy~     and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in patients~     with Herpes Zoster.~   "
170997|NCT01327118|"~     The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of~     brain vessels.~   "
171018|NCT01326845|"~     The objective of the study is to evaluate and compare the frequency and severity of GI~     adverse events in different dose administration regimens. The patient population consists of~     low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional~     iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day~     deferasirox or an evening dose of the same. Patients are then followed up for 6 months for~     any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.~   "
171781|NCT01316835|"~     This study will evaluate whether the addition of sitagliptin treatment provides additional~     decrease in HbA1C levels and increase in goal attainment in patients with inadequate glycemic~     control on their current oral anti-glycemic therapy in real world practice.~   "
170998|NCT01327105|"~     The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first~     permanent birth control method that can be performed in the comfort of a physician's office~     without hormones, cutting, burning or the risks associated with general anesthesia or tubal~     ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix~     without incisions. Over the next three months, the body forms a natural barrier around the~     micro-inserts to prevent sperm from reaching the egg. Three months after the Essure~     procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is~     called a hysterosalpingogram and evaluates the location of the inserts and whether the~     fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to~     evaluate the location of the inserts.~      The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective~     method of confirming micro-insert location.~   "
170999|NCT01327092|"~     One aim of this study is to test the efficacy of the installation of multiple, passive~     measures to reduce exposure to injury hazards in the homes of young children of first-time~     mothers and reduce childhood injury. The study also seeks to identify sub-groups of mothers~     and children who benefit most from the intervention and examine the potential moderating~     effect of maternal depressive symptoms, the intensity of supervisory behavior, and child~     temperament and activity, on the intervention and subsequent injury outcomes.~      Specific Aim 1 Hypotheses:~      H1.1: The housing units randomly assigned to the intervention group will have a significant~     decrease in the number and density (number per area) of residential injury-related hazards~     compared with control group units.~      H1.2: Children who are randomized to the intervention group (e.g. installation of multiple,~     passive measures to reduce exposure to residential injury hazards) will have a 50% reduction~     in modifiable and medically-attended injuries compared with children in the control group~     followed-up for 24-months in intention-to-treat analyses.~      Specific Aim 2: Hypotheses H2.1: Persistent maternal depressive symptoms will moderate the~     effects of the intervention on childhood injury in the home; households and children of~     mothers with higher levels of symptoms will have more hazards and injuries.~      H2.2: Children of mothers with less intense maternal supervisory behavior over the course of~     the intervention follow-up will have higher rates of injury.~      H2.3: Children scoring high in activity on the Carey Temperament Scale will experience~     reduced benefits of the intervention on childhood injury in the home.~   "
171000|NCT01327079|"~     This proposed investigation will test the following hypotheses: 1) Enzymatic activity of~     CYP2B6 characterized by the formation clearance of methadone to EDDP (CLf,EDDP), is directly~     related to both gestational and postnatal age; 2) variations in the CYP2B6 gene (SNPs) are~     associated with variable activity of the CYP2B6 enzyme (as measured by the formation~     clearance, CLf,EDDP), and 3) the elimination rate of methadone and its major metabolite EDDP~     in neonates is dependent on the glomerular filtration rate and therefore on the stage of~     development (defined by both gestational and postnatal age). The investigators propose to~     develop a PK model for methadone dosing in neonates that takes into account both~     developmental stage and genetic variability. The long-term goal of the proposed~     investigations is to improve dosing of methadone in neonates exposed to opioids in utero or~     post-natally, leading to improved control of their withdrawal syndrome and decreased adverse~     drug reactions associated with the current use of methadone in these vulnerable patients.~     More immediately, the investigators will develop a PK model for methadone dosing based on~     relevant developmental and genetic characteristics. The acquired knowledge based on the~     proposed study will lead to a more efficacious treatment of pain or opiate withdrawal~     syndrome in newborn infants with a decreased chance of adverse drug reactions.~   "
171001|NCT01327066|"~     The purpose of this study is define the electrocardiographic (ECG) effects of Droxidopa at~     clinical (600 mg) and supratherapeutic (2000 mg) doses compared with placebo and moxifloxacin~     in healthy male and female subjects.~   "
171002|NCT01327053|"~     This study will assess the efficacy and safety of oral treatment with two dose levels of~     LDE225 in patients with locally advanced or metastatic BCC.~   "
171003|NCT01327040|"~     Circadian rhythm disorders are a class of sleep disorders characterized by misalignment~     between the timing of sleep and the timing of rhythms driven by the biological clock. Light~     therapy can effectively treat these disorders, but the intensity and duration of light~     exposure required to do so has limited its practical use. In this study the investigators~     will test whether pre-exposure to dim light may enhance the response of the circadian system~     to light therapy. If so, this could result in shorter treatments that would have greater~     practical applications.~   "
171004|NCT01327027|"~     This research is being done because we wish to understand how a chemical produced in the~     brain, vasopressin, effects emotional social communication processes. Understanding how this~     system works in normal individuals may help us understand why some people, particularly those~     with autism and/or antisocial personality disorder, have dysfunctional social interactions.~      This study will test the effects of 3 doses of arginine vasopressin, delivered intranasally,~     on physiological and behavioral responses to the faces of same- and other-sex individuals in~     healthy men and women.~   "
171005|NCT01327014|"~     The purpose of this study is to demonstrate the efficacy of XueZhiKang to improve plasma~     lipid profile, as compared to placebo, in outpatients with hyperlipidemia.~   "
171006|NCT01327001|"~     Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol~     or salmeterol/fluticasone) in the Czech Republic.~      There is a hypothesis that doctors should prescribe to each patients per year: six units of~     fixed combination budesonide/formoterol, or seven units of fixed combination~     budesonide/formoterol in approach SMART, or twelve units of fixed combination~     salmeterol/fluticasone. With regard to current prices the treatment by fixed combination~     budesonide/formoterol should cost less.~      The investigators do not have any data about real life utilization of fixed combination in~     asthma treatment in Czech Republic The investigators propose to conduct a non-interventional~     multicentric retrospective epidemiological study looking into the patients records kept by~     specialist - allergists and pulmologists.~      Retrospective data for eligible patients will be reviewed by participating investigators,~     physicians taking care of their patients, and recorded in the electronic CRF. Only patients~     who have been treated for asthma bronchiale (classification of severity - moderate or severe~     persistent asthma) with fixed combination for at least one year could be included into the~     study. There are no scheduled visits for any patient participating in the study.~   "
171007|NCT01326988|"~     The traditional landmarks to locate the injection site and orientation of the spinal needle~     for spinal anesthesia are based on palpation of surface bony landmarks. However the actual~     injection target into the CSF is located at an unknown depth inside the patients 3~     dimensional spinal anatomy which can itself vary in its orientation relative to these surface~     markers.Also bony surface markers may not be palpable in some patients or the patient may~     have altered spinal alignment. Thus an already blind procedure can become even more misguided~     involving multiple trial and error needle insertions. On the other hand ultrasound allows~     visualisation of deep target structures which are impalpable, it allows assessment of spinal~     alignment and thus directs the orientation of the seeking needle more accurately. Performing~     US in real-time during needle insertion gives continuous feedback about the correct needle~     approach path which should reduce the number of blind needle passes.~   "
171008|NCT01326975|"~     In this study, the investigators want to observe how continuous positive airway pressure~     delivered by two different modalities affects breathing pattern in small preterm infants.~     Using a specialized feeding tube in the stomach, the investigators can measure and compare~     how the diaphragm (a large breathing muscle) might be affected by those two modalities.~   "
171009|NCT01326962|"~     This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra~     (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an~     inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients~     will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks~     for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study.~     Anticipated time on study treatment is 24 weeks.~   "
171010|NCT01326949|"~     Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It can~     extend downstream to the portal branches, or upstream to the splenic and/or the mesenteric~     veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients.~     Recent studies demonstrate that the presence of PVT is not only an independent predictor of~     failure to control active variceal bleeding and prevent variceal rebleeding, but also~     significantly associated with increased mortality in patients with liver cirrhosis.~      However, in recent American Association of the Study of Liver Disease (AASLD) practice~     guidelines and Baveno V consensus, no treatment strategies in cirrhotic patients with PVT was~     clearly recommended due to the absence of randomized controlled trials.~   "
171011|NCT01326936|"~     This project seeks to develop a comprehensive, computer-based education program for primary~     care physicians that will improve their skills in structured substance abuse screening, brief~     interventions, and referral and treatment (SBIRT). The investigators will develop two online~     education programs based on virtual patient (VP) technology. One program will include five~     typical, interactive, problem-solving VPs and the second will include five identical VPs~     except that two VPs will have been worked by substance abuse experts and presented as case~     studies. The remaining three VPs will be unworked (typical VPs). The investigators~     hypothesize that both education programs will significantly improve educational outcomes,~     compared to no training, as measured by a validated survey tool. A secondary hypothesis is~     that physicians using the worked (guided learning) program will achieve similar educational~     results as those using the typical VP approach, but will require less training time.~   "
171012|NCT01326923|"~     This is an open label, single arm Phase II study of induction chemotherapy followed by~     concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell~     cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced~     HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated~     initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed~     by a week of no treatment for interim evaluation, followed by definitive concurrent~     chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The~     hypothesis of the study is that the use of cetuximab during induction chemotherapy followed~     by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve~     local control as well as distant spread.~   "
171013|NCT01326910|"~     This three week study will be conducted to determine the safety and efficacy of an~     over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.~   "
171014|NCT01326897|"~     The purpose of the study is to learn how to make homes more supportive of healthy eating and~     physical activity. As part of the study, participants will be randomly assigned to one of two~     groups. One group will receive materials with information on healthy eating and physical~     activity. The materials will be mailed 3 times over a 5 month period. The other group will~     work with a coach to make their homes more supportive of healthy eating and physical~     activity. Working with a coach involves 3 home visits and 4 coaching telephone calls over a 5~     month period. This group will also receive materials by mail 4 different times. All~     participants will be asked to complete 7 telephone interviews over a 1 year period.~     Participants will also be asked to wear an accelerometer, a small portable device that tracks~     movement from physical activity, for 7 days at 2 different points in the study.~   "
171015|NCT01326884|"~     A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day~     information on use of the Zenith LP AAA Graft.~   "
171016|NCT01326871|"~     This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation~     study of ALT-801 in a biochemotherapy regimen either containing cisplatin and gemcitabine or~     containing gemcitabine alone in patients who have muscle invasive or metastatic urothelial~     cancer of bladder, renal pelvis, ureters and urethra. The purpose of this study is to~     evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended dose~     (RD), and assess the anti-tumor response of ALT-801 in combination with cisplatin and~     gemcitabine or ALT-801 in combination with gemcitabine alone. The pharmacokinetic profile of~     ALT-801 in combination with cisplatin and gemcitabine will also be assessed. The study~     includes a dose escalation phase (Phase Ib) and a dose expansion phase (Phase II). Phase II~     has two treatment groups, Expansion Group 1 and Expansion Group 2. Expansion Group 2 is for~     platinum-refractory patients, consisting of two treatment arms based on the patient's renal~     function. Patients will enroll to Expansion Group 2 after stage 1 of the Group 1 expansion is~     complete.~   "
171017|NCT01326858|"~     The purpose of this study is to assess the ocular comfort and safety of olopatadine~     hydrochloride opthalmic solution. 0.7%.~   "
171019|NCT01326832|"~     Using the traditional and hitherto used uncemented hip prostheses achieved good clinical~     results, but one of the drawbacks is the risk of fracture in the femoral shaft in indbankning~     of the prosthesis (1-2%). In addition, the bone scan demonstrated that in the years after~     surgery dropped almost 30% of bone mass in the femoral shaft. This bone loss increases the~     risk that in the years after surgery, the increased risk of fractures around the prosthesis~     and in addition to impeding the described bone replacement prosthesis later.~      The newly developed prosthesis is anchored in the femoral neck and thus not involve the~     femoral shaft. This ensures a more physiological or normal weight transfer to the femur bone.~      This contributes to bone mass in long large extent preserved in the years after surgery, so~     you have a better opportunity later to make a new prosthesis surgery with good results. The~     new prosthesis should be capable of simultaneously reducing the incidence of thigh pain in~     the first year after surgery.`~   "
171020|NCT01326819|"~     Observational comparison study of three commercially available regional oxygen saturation~     devices on a wide range of skin colors.~   "
171021|NCT01326806|"~     The purpose of this study is to test the efficacy of a parent-based intervention designed to~     prevent adolescent sexual risk behavior in Latino and African American inner city youth. The~     intervention will be administered in the context of mothers waiting for their children to~     complete an annual physical exam required for school admission.~   "
171022|NCT01326793|"~     This study aims to determine whether using telecommunication tools, specifically web pages~     containing online screening instruments and real-time video chat, will be an efficient way to~     implement Major Depressive Disorder screening among college students. The study also aims to~     determine if proactive depression screening and free online consultation with a psychiatrist~     will increase the rate of help-seeking among college students with MDD.~      Eligible participants will complete a demographics survey and depression screening assessment~     online. Those subjects who express suicidality or depressive symptoms will be offered the~     opportunity to complete a one-time psychiatric consultation with Skype video-conferencing.~   "
171023|NCT01326780|"~     A study to determine if three different doses of a new acne treatment are safe and better at~     reducing facial acne than a treatment without active ingredient.~   "
171024|NCT01326767|"~     This study will be performed on grade IIIb and grade IV Non Small Cell Lung Cancer (NSCLC)~     chemotherapy naive patients with good performance status. In course of this study, patients~     will be treated with Paclitaxel in combination with either Cisplatin or Carboplatin in a~     maximum of six therapy cycles. The goal of this study is to determine, if a pharmakokinetic~     driven dose adaptation of paclitaxel leads to a reduction of of grade 4 neutropenia, compared~     to conventional Paclitaxel dosing, without affecting progression free survival and overall~     survival.~      This study includes a biomarker analysis and an optional genetic substudy.~   "
171025|NCT01326754|"~     Background: Malaria is a cause of substantial morbidity and mortality in Malawi. Prompt and~     effective treatment of uncomplicated malaria remains a key strategy to reduce the public~     health burden of malaria. Due to the rising resistance to and falling efficacy of~     sulfadoxine-pyrimethamine, the first-line treatment of uncomplicated malaria from 1993 to~     2007, the National Malaria Control Program (NMCP) revised the national treatment guidelines~     in 2007. The revised treatment guidelines recommend artemether-lumefantrine as the first-line~     treatment for uncomplicated malaria and artesunate-amodiaquine as a second-line treatment for~     uncomplicated malaria. The change in policy was based primarily on efficacy data from other~     countries in sub-Saharan Africa. However, although both artemether-lumefantrine and~     artesunate-amodiaquine have been in use in Malawi since 2007, there are relatively few~     studies assessing their efficacy. In a study conducted in 2004-2006 in Blantyre,~     artemether-lumefantrine was found to be efficacious.1 In addition, a more recent assessment~     of artemether-lumefantrine in vivo efficacy conducted in six sites in Malawi in 2009 also~     suggests that the standard formulation artemether-lumefantrine remains highly efficacious~     (Kamija Phiri, personal communication).~      Although, some Malawi-specific data on the in vivo efficacy of the standard formulation of~     artemether-lumefantrine exists, there are additional data that is needed to support the~     current policy and inform future policy decisions. In 2010 the NMCP has introduced the~     dispersible formulation of artemether-lumefantrine (Coartem-D™) for use as a first-line~     antimalarial in Malawi, due to the global unavailability of the standard formulation of~     artemether-lumefantrine from Novartis, the key supplier of the standard formulation of~     artemether-lumefantrine (Coartem™) in Malawi. In light of these developments, an assessment~     of the efficacy, safety and tolerability of the dispersible formulation of~     artemether-lumefantrine is warranted. In addition, the efficacy, safety and tolerability of~     co-formulated artesunate-amodiaquine, the current secondline treatment for uncomplicated~     malaria, has never been assessed in Malawi and should be evaluated. Lastly,~     dihydroartemisinin-piperaquine has recently been added to the new World Health Organization~     (WHO) guidelines for the treatment of uncomplicated malaria. This promising new antimalarial~     might have a role as a first-line or second-line antimalarial for the treatment of~     uncomplicated malaria, but there are no efficacy and safety data from Malawi. This knowledge~     gap needs to be addressed to help inform policy makers about the potential role of~     dihydroartemisinin-piperaquine for the treatment of uncomplicated malaria in Malawi.~      Objective: Efficacy and safety of the dispersible formulation of artemether-lumefantrine,~     co-formulated artesunate-amodiaquine and co-formulated dihydroartemisinin-piperaquine for the~     treatment of uncomplicated Plasmodium falciparum malaria at Machinga District Hospital-~     Malawi~      Methods: An antimalarial drug efficacy trial will be conducted in Malawi. The participants~     will be febrile people 6-59 months old with confirmed uncomplicated P. falciparum infection.~     Patients will be sequentially allocated to receive treatment with either the dispersible~     formulation of artemether-lumefantrine at a dose of 2/12 mg/kg body weight of artemether and~     lumefantrine, respectively, per dose, given twice a day for 3 days; or co-formulated~     artesunate-amodiaquine at a dose of 4 mg/kg/day artesunate and 10 mg/kg/day amodiaquine once~     a day for 3 days; or co-formulated dihydroartemisinin-piperaquine at a dose of 4 mg/kg/day~     dihydroartemisinin and 18 mg/kg/day piperaquine once a day for 3 days. Clinical and~     parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug~     effi¬cacy. The study will be conducted from January to December, 2011. The results of this~     study will be used to assist the Ministry of Health in Malawi in assessing the current~     national treatment guidelines for uncomplicated P. falciparum malaria.~   "
171026|NCT01326741|"~     Anaphylaxis is a serious allergic reaction that develops rapidly and can cause death. Some~     patients experience anaphylaxis is association with exercise, a disorder called~     exercise-induced anaphylaxis. A subset of patients with unexplained anaphylaxis, especially~     those with hypotension during the anaphylactic episodes, have been shown to have abnormal,~     clonal populations of a certain cell type, mast cells, in the bone marrow. This has been~     described in at least one patient with exercise-induced anaphylaxis. The investigators would~     like review the findings in a group of patients with exercise-induced anaphylaxis who have~     undergone evaluation for the presence of abnormal, clonal mast cells.~   "
171027|NCT01326728|"~     Background:~      Allogeneic hematopoietic stem cell transplantation (or allotransplant; donor blood stem~     cells) have been used with varying degrees of success as an immune therapy for blood-system~     cancers (leukemias, myelodysplastic syndrome, lymphomas, multiple myeloma, etc.). Some people~     s cancer remains active (comes back or continues to spread) after an allotransplant, while~     other people s cancer disappears and they are hopefully cured . NIH researchers are studying~     the reasons for these different treatment outcomes, and trying to develop better cancer~     treatments for people with active cancer after allotransplant. Researchers are collecting~     data from people who have had allotransplants for a cancer of the blood, whether or not the~     cancer is in remission, and from their donors. Those with active cancers may be eligible to~     participate in one of several NIH studies testing treatments for active cancer after~     allotransplant.~      Objectives:~        -  To develop a systematic, comprehensive evaluation of individuals with relapsed malignant~          blood cancers after allotransplant (and, if available, their donors) to identify~          potential treatment study options~        -  To compare the immune system after allotransplant between people whose cancers are~          growing with people whose cancers remain in remission.~        -  To compare the immune system after cancer relapse/progression treatment between people~          whose cancer responds to treatment with those whose cancers continue to grow.~      Eligibility:~        -  Individuals whose blood system cancer grows or comes back after receiving allotransplant~          treatment.~        -  Individuals whose blood system cancer is responding or in remission 100 days or more~          after receiving allotransplant treatment.~        -  Related stem-cell donors of eligible allotransplant recipients.~      Design:~        -  Participants will be evaluated with a full physical examination, detailed medical~          history (for recipients, including a history of allotransplant treatment process,~          side-effects, etc.), and blood tests. Recipients will also have imaging studies,~          possible tissue biopsies, quality of life questionnaires/assessments, and other tests to~          evaluate the current state of their cancer, whether active or in remission. In some~          cases, it may be possible to substitute results from recent tests and/or biopsies.~        -  Healthy related donors will have apheresis to provide white blood cells for study and/or~          for use in potential treatment options. If stem cells would be medically helpful to a~          recipient, their donors might be asked to take injections of filgrastim before the~          apheresis procedure to stimulate the production of stem cells for collection.~        -  As feasible, all recipients will be asked to return to the NIH for detailed follow-up~          visits in conjunction with 6, 12, and 24 months post-allotransplant evaluations, and may~          be monitored between visits.~        -  Recipients whose cancers are active and who are found to be eligible for treatment~          protocols at the NIH will continue to be monitored on this study while participating on~          treatment protocols. Return visits and follow-up tests for this study will be~          coordinated with those required by the treatment protocol.~        -  Participants may return in the future to be evaluated for new treatment study options~          (recipients) or additional cell donations for therapy (donors).~   "
171028|NCT01326715|"~     Background:~      - Contrast agents are drugs that make certain body areas or abnormalities show up better on~     imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI~     contrast agent with manganese that has been approved for MRI scans of the liver and pancreas.~     Because contrast agents with manganese have also been shown to be useful in studying problems~     with the nervous system, researchers are interested in determining if mangafodipir may be~     used for MRI scans of the brain or eye, two areas that often experience problems caused by~     disorders that affect the nervous system, such as multiple sclerosis. However, more~     information is needed on whether mangafodipir will be useful for this purpose, or how best to~     use it in MRI scans of the eye and brain. To study mangafodipir more closely, researchers are~     interested in studying its use in both individuals with multiple sclerosis and healthy~     volunteers.~      Background:~      - Contrast agents are drugs that make certain body areas or abnormalities show up better on~     imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI~     contrast agent with manganese that has been approved for MRI scans of the liver and pancreas.~     Because contrast agents with manganese have also been shown to be useful in studying problems~     with the nervous system, researchers are interested in determining if mangafodipir may be~     used for MRI scans of the brain or eye, two areas that often experience problems caused by~     disorders that affect the nervous system, such as multiple sclerosis. However, more~     information is needed on whether mangafodipir will be useful for this purpose, or how best to~     use it in MRI scans of the eye and brain. To study mangafodipir more closely, researchers are~     interested in studying its use in both individuals with multiple sclerosis and healthy~     volunteers.~      Objectives:~      - To evaluate the safety and effectiveness of mangafodipir in imaging studies of nerve~     disorders affecting the eye and brain.~      Eligibility:~      - Individuals between 18 and 70 years of age who either have been diagnosed with multiple~     sclerosis or are healthy volunteers.~      Design:~        -  Participants will be screened with a physical examination, medical history, and blood~          tests.~        -  Participants will have up to 10 outpatient visits for screening and MRI scans over a~          period of up to 2 months. Participants will be divided into Eye and Brain groups, based~          on which area will be studied during the scans. (Participants who have available time~          may be eligible for study in both groups.)~        -  Participants will have an initial MRI scan as part of the screening process.~        -  At the first visit, participants will have a baseline MRI scan once before receiving~          mangafodipir.~        -  Participants will have up to five MRI scans, with the following procedures:~        -  Eye imaging group: MRI scans will be scheduled at specific times between 2 and 48 hours~          after receiving mangafodipir. Eye MRI participants will wear a dark contact lens and an~          eye patch for 30 minutes before receiving mangafodipir, and leave both on for up to 8~          hours. The other eye will remain uncovered.~        -  Brain imaging group: MRI scans will be scheduled at specific times between 48 hours and~          7 days after receiving mangafodipir.~        -  Participants will have a follow-up MRI scan 1 month after receiving mangafodipir. This~          scan is done to see how long mangafodipir may affect MRI images of the brain.~   "
171029|NCT01326702|"~     This phase I/II trial studies the side effects and the best dose of veliparib when given~     together with bendamustine hydrochloride and rituximab and to see how well they work in~     treating patients with lymphoma, multiple myeloma, or solid tumors that have come back or~     have not responded to treatment. Veliparib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can~     block cancer growth in different ways. Some find cancer cells and help kill them or carry~     cancer-killing substances to them. Others interfere with the ability of cancer cells to grow~     and spread. Giving veliparib together with bendamustine hydrochloride and rituximab may kill~     more cancer cells.~   "
171030|NCT01326689|"~     This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and~     safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose~     titration in treating breakthrough pain episodes in adult cancer patients receiving strong~     opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.~   "
171031|NCT01326676|"~     Medications that lower blood pressure and cholesterol are known to improve the shape and~     function of our blood vessels. These improvements include a reduction in the thickness of the~     wall of the carotid artery (the main artery that runs up the neck to supply the brain) and a~     reduction in the stiffness of arteries generally including the main central artery -the~     aorta. Such medications are in the polypill (the Red Heart Pill) that is being used in the~     UMPIRE Study. In UMPIRE, patients' reported adherence to taking the single, once daily~     polypill is being compared to adherence to medications taken as separate tablets (usual~     care).The aim of the PESCA sub-study is to see whether or not the polypill differs from~     'usual care' in its direct effects on blood vessels as shown by ultrasound examination of the~     carotid arteries and assessment of central (aortic) blood pressure.~   "
171032|NCT01326663|"~     Despite the body's natural healing during the first year after a head injury, many veterans~     who have suffered even mild brain injuries find themselves easily upset or fearful as they go~     about their daily lives. While these reactions to the world around them were easily managed~     before the head injury, they now occur with little or no interruption and are exceedingly~     difficult to manage. Such reactions include a sense of always being upset or fearful that~     often makes it difficult to get along with family members, friends, coworkers, and employers.~     This may lead to broken marriages, unemployment, and even homelessness.~      Some people with head injuries try to manage their unmanageable moods by drinking alcohol~     because it can create a sense of calm. However, alcohol's actions are short in duration. Most~     find that they have to drink more and more for a similar calming effect, and they soon become~     dependent on alcohol. This makes working and being part of their families even more~     difficult.~      To treat the unmanageable mood, we tried a medicine called valproate, one that eases mood~     problems in people without head injury. We gave valproate to head injured persons with mood~     problems in a non-blinded study where both the doctor and the patient knew that the~     medicine was valproate and both were optimistic that it would work. In a small sample of~     eighteen people, 85% found mood relief and most of those either stopped drinking alcohol or~     drank much less than before. However, this might have been because both the doctor and~     patient were hopeful that the medication would make the patient feel better or because the~     medicine actually worked.~      The only way to know for sure if the medicine works is to perform a study in which people~     receive either valproate or a sugar pill while neither they nor their doctor know which one~     they are taking. This is called a double blind study, as proposed here, and will involve~     nearly three times as many head injured persons as the first study.~      If it is successful, this study will show that valproate treatment helps head injured people~     manage their moods and allows them to return to families, friends, and work. It will also~     show that they drink alcohol less or not at all, improving their health even further. Then~     doctors will know that they can use this medicine for large numbers of people who suffer from~     head injury and help them to lead normal lives. If the outcome of the study shows that the~     medicine works well, doctors can then use this medicine to treat people with head injury~     immediately after the study results are published.~   "
171033|NCT01326650|"~     Despite significant therapeutic improvements, congestive heart failure (CHF) patients still~     have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an~     accumulating body of evidence from prospective cohort studies that low circulating~     25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality,~     respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that~     vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether~     vitamin D supplementation reduces mortality and increases event-free survival in end-stage~     CHF patients.~   "
171034|NCT01326637|"~     Human factors engineering literature makes clear that appropriate, well-designed and~     well-timed information improves decision making and can reduce mental workload. Data from a~     previous study showed that appropriate, well-designed and well-timed information is not~     present in many primary care encounters with elderly patients. This puts primary care~     physicians at risk of higher mental workload and poor decision making which can affect the~     quality and safety of care delivered to patients. Elderly patients are at particular risk~     because they are more likely to have more comorbidities, medications, and cognitive~     impairments.~      Dr. Karsh and his research team will test an intervention to improve the performance of~     primary care physicians and, thus the safety of primary care of the elderly. The~     investigators will use a randomized experiment, with random assignment at the level of~     patient, to test and evaluate the intervention. The evaluation will involve 4 primary care~     clinics, with 4 primary care physicians per clinic. The investigators will collect data from~     768 patient visits pre-intervention and 1536 patient visits during the intervention.~     Intervention patients will be randomly assigned to the intervention or care as usual.~      The Intervention has two components:~      Pre-visit care coordination:~        -  5-7 days prior to a study patient's appointment with his/her doctor, the doctor's~          nurse/MA will call the study patient and collect pertinent clinical information about~          the patient using a data collection form the investigators call a Patient Overview~          Document or POD.~        -  The nurse/MA will ensure that any lab results, consultant reports, ER reports, imaging~          studies, etc., that will be needed by the physician are available to the doctor.~      Team Meeting:~      On the day of the patient's appointment and prior to the beginning of the clinic session, the~     nurse/MA will meet briefly with the doctor to jointly review the POD.~      Hypotheses:~      H1. Primary Care Physician (PCP): The intervention will increase situation awareness, reduce~     PCP mental workload, reduce PCP perceived likelihood of error, and improve PCP visit~     satisfaction. PCP efficiency, as measured by encounter problem density during a visit, will~     also improve.~      H2. Patient: The intervention will improve patients' perceptions of their visits on a variety~     of AHRQ CAHPS measures, such as physician knowledge of patient history.~      H3. Patient: The intervention will not impact the number or types of problems addressed~     during the visit.~      H4. Clinic: The intervention will not affect visit RVUs~   "
171035|NCT01326624|"~     The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use~     in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a~     high-risk for sudden cardiac death but are either not eligible for an implantable~     defibrillator under current guidelines or are not able to receive the device due to their~     condition.~   "
171036|NCT01326611|"~     The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of~     ureaplasma urealyticum and prevention of chronic lung disease in premature infants with~     birthweight < 1250 g and have ureaplasma urealyticum colonization.~   "
171037|NCT01326598|"~     The aim of the present study is to observe glycemic control, dose requirements, hypoglycemia~     risk, other possible adverse effects and weight changes, as well as to compare these~     parameters to prior treatment when patients with type 2 diabetes are initiated and treated~     using V-Go during circumstances as close to normal clinical practice as possible.~   "
172277|NCT01310205|"~     This is an extension of ongoing study SCI-SCV-HCV-P2-001 in which subjects will be invited to~     participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001~     and are eligible for retreatment with peg-IFN and RBV.~   "
171038|NCT01326585|"~     Dexamethasone is a medication that has been shown to have clear anti-nausea,~     anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage~     postoperative symptoms of a variety of surgical procedures. However, its effect has not been~     validated for scleral buckling surgery, which is used to treat retinal detachment, a medical~     emergency that can lead to permanent blindness. In this study, the investigators will~     randomly administer dexamethasone to half of scleral buckling surgery patients, and a placebo~     to the other half. The investigators will then compare the postoperative symptoms of the two~     groups in order to determine whether dexamethasone should be used for scleral buckling~     surgeries.~   "
171039|NCT01326572|"~     HIV-infected patients have an increased incidence of emphysema compared to non-HIV-infected~     patients, and it has been hypothesized that this accelerated disease progression is the~     result of one or more latent infections that amplifies the pulmonary inflammatory response.~     The investigators will examine the prevalence and progression of emphysema in subjects with~     and without HIV and determine risk factors for emphysema in this population.~   "
171040|NCT01326559|"~     Study Objective:~      Primary~      1. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel,~     Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with~     intensity-modulated radiotherapy (IMRT).~      Secondary~        1. To determine the overall response rate.~        2. To determine the locoregional and distant control rate~        3. To determine the progression-free survival (PFS)~        4. To determine the overall survival (OS)~        5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus~          Cetuximab.~   "
171041|NCT01326546|"~     The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine~     (synthesized peptide) Joint entecavir treatment in chronic hepatitis B patients.~   "
171042|NCT01326533|"~     The purpose of this study is to determine the short-term effects of the antimalarial~     medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled~     intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin~     secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.~   "
171043|NCT01326520|"~     The aim of the study is to investigate the influence of a milk phospholipid enriched dairy~     product on subjects with atopic dermatitis determining parameters of the immune status, the~     plasma lipid profile and the skin texture.~   "
171044|NCT01326507|"~     The patients presenting with acute pulmonary embolism and right ventricular dysfunction are~     at high risk for life-threatening events and must be identified in the emergency department~     for adequate care and hospital admission. Echocardiography can identify right ventricular~     dysfunction, but this test is not always available, and echocardiographic criteria of right~     ventricular dysfunction vary among published studies. The primary purpose of this protocol is~     to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding~     Protein) , to identify in the emergency department the patients presenting with high risk~     pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac~     biomarkers (BNP, troponin) and clinical score performances that have been previously studied~     to stratify the prognosis of patients with pulmonary embolism in the emergency department.~   "
171045|NCT01326494|"~     The purpose of this study is to investigate the benefits of giving filled prescription of a~     medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to~     reduce the need to present to Health Care centres for treatment.~   "
171046|NCT01326481|"~     The purpose of this study is to determine the recommended phase 2 dose and overall safety and~     tolerability of TRC105 when given in combination with capecitabine for the treatment of~     patients with progressive or recurrent metastatic breast cancer.~   "
171047|NCT01326468|"~     Patients with advanced head and neck cancer is at high risk of recurrence at the primary site~     or in the neck. Part of normal treatment is to treat such patients with chemotherapy and~     radiation. The chemotherapy can include Erbitux. The purpose of this study is to treat such~     patients with an additional agent, Torisel. This study tests the doses of Torisel that can be~     safely administered together with radiation and chemotherapy.~   "
171048|NCT01326455|"~     The purpose of this pilot study was to compare two devices and three methods for achieving~     hemostasis after a transradial angiogram while assessing vascular complications and time~     endpoints. The heart has traditionally been accessed through the femoral artery. However, in~     the last 20 years, the radial artery has gained more popularity among physicians and~     patients, thereby offering an alternative to the femoral approach. Various methods of~     applying compression to the radial puncture site have been used, but no research has been~     done to show what best practice is. In this case, best practice would be the most effective~     way of getting hemostasis while limiting complications and ensuring the efficient use of~     nursing and medical resources. It is hypothesized that statistically significant differences~     are seen in time to discharge in the fast-release Terumo and Clo-Sur P.A.D. groups, as~     compared with the control Terumo group, without increasing vascular complications.~   "
171049|NCT01326442|"~     The study will test the hypothesis that supplementing the diet of subjects with Metabolic~     Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will~     facilitate weight loss, improve body composition and reduce metabolic and biochemical risk~     factors associated with type II diabetes and cardiovascular disease. Adult men and women who~     meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled~     and embark on a 16 week diet and exercise intervention using a low glycemic index diet with~     or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and~     blood collected at weeks 0 and 16.~   "
171050|NCT01326429|"~     Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized~     patients. The increasing use of diuretics and other medications influencing the water and~     sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte disorders.~     Only little data is available on the frequency and the mechanisms leading to~     hypo-/hypernatremia.~      Thus, the investigators aim to A.) determine the frequency of hypo- and hypernatremia in the~     emergency department of a large tertiary university hospital and B.) explore the mechanisms~     leading to the development of dysnatremias by detailed clinical and laboratory examinations.~   "
174633|NCT01279239|"~     The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe~     multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics~     methodology and advanced mathematics tools.~   "
171051|NCT01326416|"~     Android obesity contributes, via insulin resistance and endothelial dysfunction, to the~     development of cardiovascular atherosclerosis. It leads to poor quality of life. It is often~     associated with metabolic syndrome which includes, whatever the definitions used (National~     Education Cholesterol Program, NECP / Adult Treatment Panel III, ATP III or International~     Diabetes Federation, IDF), an increased waist measurement, an arterial high blood pressure~     and disorders of the glucide and lipid metabolism. The treatment of the current epidemic of~     obesity and metabolic syndrome in France (12.4 % of obese and 14 % of subjects with metabolic~     syndrome) thus requires new therapeutic approaches.~      A well-balanced diet and a daily physical activity are the indispensable requirements for the~     treatment of obesity and metabolic syndrome. It is possible to associate it to~     pharmacological agents, but the results are often partial and transient. Preliminary data~     suggest that leucine or arginine supplementation could facilitate the loss of fat mass.~     Moreover, the physical exercise has also demonstrated benefits.~      Sessions of physical reconditioning (aerobic work + muscular intensification) associated with~     a program of specific nutritional supplementation by a mixture of Leucine and Arginine (in~     the daytime) could improve the treatment of obese subjects affected by metabolic syndrome.~   "
171052|NCT01326403|"~     This is a randomized controlled trial comparing the use of tranexamic acid to placebo in~     patients admitted to hospital with a hip fracture.~   "
171053|NCT01326390|"~     Impact on contrast dose or total volume of contrast required to effectively treat the~     targeted tumor.~   "
171054|NCT01326364|"~     The purpose of this study is first, to determine whether baseline perfusion characteristics~     of pancreatic cancer, as characterized by CT perfusion studies, can predict tumor response to~     treatment by stereotactic body radiotherapy (SBRT). The second goal of this study is to~     determine whether baseline perfusion characteristics in those patients with resectable~     pancreatic cancer correlate with immunohistologic markers of angiogenesis such as microvessel~     density and vascular endothelial growth factor (VEGF) expression.~   "
171055|NCT01326351|"~     The purpose of this study is to demonstrate that prolotherapy in conjunction with a~     physiotherapy program looking at reinforcing calf muscle and muscle of the plantar fascia,~     relieves pain and improves function of people suffering of plantar fasciitis, an inflammation~     of the plantar fascia, after basic treatment failure.~   "
171056|NCT01326338|"~     The purpose of this study was to determine the efficacy of nitazoxanide suspension compared~     to placebo in treating prolonged diarrhea in children.~   "
171057|NCT01326325|"~     Long-term opioid therapy is commonly administered for the management of severe cancer pain.~     Increasing doses of opioids are titrated against effects until analgesia is achieved or~     intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor~     antagonist, has been reported to improve analgesia in patients with uncontrolled pain~     receiving high doses of opioids. This study aims at determining the effectiveness of ketamine~     as an adjuvant to opioids in relieving cancer pain.~   "
171058|NCT01326312|"~     The purpose of this study is to determine whether GTx 758 is effective in achieving and~     maintaining castrate testosterone levels in men with advanced prostate cancer.~   "
171059|NCT01326299|"~     The purpose of this study is to compare the postprandial glycemic response of subjects with~     type 2 diabetes when consuming a meal along with beverages containing various combinations of~     nutritional ingredients and fibers versus control beverage.~   "
171060|NCT01326286|"~     This study will primarily compare the effectiveness of surgery and radiation for localized~     prostate cancer, the most common male cancer. It will focus on modern technologies and~     control for differences in patients and treatments that may affect both cancer-related and~     patient-reported outcomes (such as impotence and incontinence). By figuring out what~     treatments work best, in which patients and in whose hands, it will help men with prostate~     cancer make better decisions regarding their care.~   "
171061|NCT01326273|"~     The investigators will assess whether the infusion of autologous CMV-specific T-cells at the~     time of CMV reactivation posttransplant will prevent worsening of CMV virus reactivation~     posttransplant to a level that warrants therapy with antiviral drugs (objectively assessed by~     looking at CMV virus copy number).~   "
171062|NCT01326260|"~     This study involved the medical record review of resuscitation records for all~     severely-injured trauma patients requiring emergent surgical intervention and significant~     acidosis from 2005 through 2009.~   "
171063|NCT01326247|"~     The purpose of this study was to evaluate the effects of Ischia thermal waters nasal~     irrigation on allergic rhinitis and airway inflammation during the period of natural exposure~     to parietaria pollen in children with allergic rhinitis and intermittent asthma.~   "
171064|NCT01326234|"~     The current study seeks to use a computer-based program to target parents of children who~     smoke. Parents will be randomly assigned to either receive personalized feedback about their~     smoking behaviors or not. One month after gathering their baseline information, all~     participants will be asked to complete follow-up questionnaires online assessing their~     smoking behaviors.~   "
171065|NCT01326221|"~     This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and~     emtricitabine (components of Truvada) concentrations within genital tract of male and females~     after a single dose of Truvada®. Concentrations of the active drug will be measured in blood~     (women and men), cervicovaginal aspirates and vaginal tissue (women only), seminal fluid and~     rectal tissue (men only). Samples will be obtained at 24 hours (1 day), 48 hours (2 days), 5~     days, 7 days, 10 days, and 14 days post-dose. Each subject will undergo 2 biopsy days, at~     least 72 hours apart. Additionally, tissue samples will be evaluated ex-vivo for HIV~     infectivity.~   "
171066|NCT01326208|"~     The purpose of this study in patients suffering from acute lung injury is to determine~     whether positive end-expiratory pressure (PEEP) setting guided by electrical impedance~     tomography (EIT) influences pulmonary gas exchange, lung mechanics, ventilation/perfusion~     matching and homogeneity of regional ventilation when compared to other PEEP setting~     strategies such as the open lung concept or the ARDSnet protocol.~   "
171067|NCT01326195|"~     This project is designed to develop and test a group-based preventive intervention to reduce~     dating violence and sexual risk behavior among adolescent females with prior dating violence~     exposure.~   "
175168|NCT01272284|"~     An international, multi-center, single arm, prospective clinical study designed to assess the~     safety and efficacy of the Coloplast Altis single incision sling system for females with~     stress urinary incontinence (SUI).~   "
171068|NCT01326182|"~     This study is to develop and pilot test a new group-based intervention for depressed Latina~     mothers of children with asthma. The investigators ongoing work has identified that close to~     50% of Latina mothers of children with asthma report significant symptoms of depression. The~     intervention will combine asthma education and cognitive-behavioral strategies (e.g.,~     increasing the pleasant activities that you do to help your mood) to address symptoms of~     depression. The investigators hope to improve mothers' mood, their feelings of confidence~     that they can manage asthma, and children's level of asthma control.~      The project has two phases. In Phase 1, the investigators will develop the intervention by~     working on the treatment manual and then conducting focus groups with Latina mothers to get~     input on the intervention. The investigators expect 24 mothers at each of 2 sites (RI and PR)~     to participate in focus groups (8 mothers per group). The group will take approximately 1-1.5~     hours.~      In Phase 2, the investigators will conduct a small pilot of the intervention at both sites~     with new participants. At each site, 4 groups (4 sessions each) will be run. Participants~     will have an equal chance of being placed in the new intervention condition (asthma education~     and mood management), or in a control condition that covers asthma education and general~     topics regarding child health and wellness (e.g., encouraging reading, reducing screen time,~     nutrition). Participants will participate in a baseline research session, in the 4~     intervention group sessions, and then in two follow-up research sessions (one at end of~     treatment which is expected to occur two months after enrollment, and one at 4-months~     post-treatment). They will complete survey instruments that assess their own depressive~     symptoms, family demographic characteristics, access/barriers to health care, self-efficacy~     to manage asthma, social network support, and family climate, as well as their child's asthma~     symptom frequency. Children 7-12 are included only for the assessment of asthma symptoms and~     lung function, which occurs at baseline, end of treatment, and 4-month follow up for 2 weeks~     at each time point. Participation in Phase 2 is expected to take approximately 6 months.~   "
171069|NCT01326169|"~     The goal of this study is to reduce impaired driving, risky driving and alcohol-related~     negative consequences among injured emergency department (ED) patients through a telephone~     brief intervention. This study will allow researchers to test a novel method of brief~     intervention that has the potential to be convenient and efficient mechanism to deliver an~     intervention to an at-risk population. Eligible patients will be consented in the ED, will~     receive an assessment and then will be randomized into one of two conditions: 1) telephone~     brief intervention or 2) a comparison control group with a home safety educational program.~     The participant will also receive an appointment for an initial telephone call. Both~     conditions will be provided over three telephone sessions: the initial call (immediately~     following randomization) and two booster calls at 2 weeks and 6 weeks after randomization.~     Participants will provide information about their alcohol use, alcohol-related injuries,~     impaired driving, and other driving related negative consequences at 4, 8, and 12 months~     post-randomization.~   "
171070|NCT01326156|"~     This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral~     osteoarthritis.~   "
171071|NCT01326143|"~     The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of~     ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with~     severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to~     Continuous Positive Airway Pressure (CPAP) treatment.~   "
171072|NCT01326130|"~     CONTEXTE: L'Agence de la santé et des services sociaux de Montréal (ASSS) invited our~     research team to evaluate the implementation of an integrated and interdisciplinary primary~     care network for prevention and management of cardiometabolic risks (diabetes and~     hypertension) (PCR). The intervention is based on the Chronic Care Model and the development~     of an integrated services network. PCR is to be implemented in 6 territories of Centre de~     santé et de services sociaux (CSSS). A first application for funding was made to Fonds~     Pfizer-FRSQ-MSSS for an evaluation that has to be completed in the first 24 month after the~     beginning of the implementation. This application to the PHSI program at CIHR is~     complementary and will ensure an evaluation of the sustainability of PCR and of long term~     effects (40 months after the beginning of the implementation) for patients and for their~     primary care physicians.~      In each CSSS, PCR plans for : 1- an interdisciplinary team in an education center working~     with primary care physicians and offering to referred patients a pre-determined sequence of~     clinical interventions over a 2-year-period; 2- a program supporting primary care physicians~     (continuing education, documentation and clinical guidelines, referral system to second line~     of care); 3- networking between actors of Réseau local de services (RLS) insuring clinical~     information transfer required for efficient patient management.~      OBJECTIVES: 1-evaluate PCR effects according to territory, time and degree of exposure~     (specifically benefits to registered patients and support to participating primary care~     physicians); 2- identify the degree of implementation of PCR in each CSSS territory and the~     related contextual factors; 3- examine the relationship between the effects identified, the~     degree of implementation of PCR and the related contextual factors; 4- assess the impact of~     implementing PCR on the strengthening of RLS.~      METHODS: The proposed evaluation will be done through a mixed design including two~     complementary strategies. Using a quasi-experiment/before-after design, the first strategy~     is a quantitative approach looking at the program effects and their variation between~     territories. This analysis will use data from the PCR clinical database (ex.: HbA1c, BP,~     lifestyle) and from patient questionnaire inquiring about care experience, utilization of~     services, chronic care follow-up, self-management and quality of life. Around 3000 patients~     will be enlisted. A primary care physician questionnaire will enquire about PCR effects on~     their practice. Using primarily a qualitative and a case study approach, each of the 6~     territories being one case, the second strategy will identify the degree of implementation of~     PCR and the explanatory contextual factors. This analysis with use data obtained from~     semi-structured interviews with program managers. The results of this analysis will be~     summarized in a monograph for each territory. According to the type of indicator analyzed,~     objective 3 will be fulfilled using linear models or longitudinal multilevel models~     supplemented with an interpretive approach using the information from monographs and~     discussion groups. The impact of implementing PCR on RLS will be assessed through interviews~     with key informants.~      RESULTS AND EXPECTED IMPACT: Our study will identify the effectiveness of PCR and contextual~     factors associated with successful implementation and sustainability of PCR. Detailed~     contextual information will allow application of our results to other environments that have~     similar context and to other chronic conditions that could benefit from an integrated~     services network.~      KNOWLEDGE TRANSFER: Since decision makers, clinicians and researchers did and will take part~     in all phases of PRC evaluation (planning, data collection, analysis and interpretation),~     diffusion of information regarding the program is an integral part of the research process.~     In addition, results will be presented at local, regional, provincial and national~     conferences and published in reports and articles widely distributed. More specifically, a~     regional symposium will be organized to share evaluation results with all CSSS in the region~     (n=12) and with all our local and regional partners.~   "
171073|NCT01326117|"~     The investigators hypothesize that in adult patients with diabetic gastroparesis with Type 1~     diabetes (HbA1c ≤ 10.5%), daily tadalafil use will significantly improve gastric emptying~     compared to baseline as measured by gastric emptying time.~   "
171074|NCT01326104|"~     Immunotherapy is a specific approach to treating cancer that has shown promise in adult~     patients for the treatment of melanoma, malignant brain tumors, and other cancers. The study~     investigators will use the experience they have gained from these studies to try to improve~     the outcome for children affected by a recurrent brain tumor.~      This study will have two phases.~      During Phase I, approximately 9 patients will be treated with increasing doses of~     tumor-specific immune cells to determine the safety of this treatment. Phase I patients will~     also receive dendritic cell vaccines to help boost the function of these immune cells and~     maintain their growth.~      During Phase II, approximately 35 patients will be treated with tumor-specific immune cells~     and dendritic cell vaccines to see what impact they have on the tumor.~   "
171075|NCT01326091|"~     This is a parallel, randomized controlled trial comparing two types of patient positioning~     and their effect on radiologic measures (pre-surgery visit, in the operating room prior to~     surgery, at the conclusion of surgery, and at 3 weeks after surgery at patients'~     postoperative visits) as well as surgeon satisfaction (prior to the end of the surgery) and~     patient outcomes using patient self reported scales (pre-surgery, post surgery at 3 weeks~     follow-up).~   "
171076|NCT01326078|"~     The purpose of this study is to compare the safety and efficacy of the of propofol~     nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.~   "
171077|NCT01326065|"~     The purpose of this study is to study the implementation of laparoscopy-assisted surgery for~     cure of colon cancer in daily surgical practice.~   "
171078|NCT01326052|"~     The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve~     or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA~     preservation could improve patient's quality of life reducing incontinence and/or~     constipation rate.~   "
171079|NCT01326039|"~     Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine~     5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically~     analgesic effect after unilateral open inguinal hernia repair.~   "
171080|NCT01326026|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in~     insulin naïve subjects with type 2 diabetes mellitus when titrated using two different~     self-titration algorithms (dose individually adjusted) in combination with metformin.~   "
171081|NCT01326013|"~     The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) is a PCR-based assay to detect the~     presence or absence of gastrointestinal (GI) pathogens from human stool specimens.~      The objective of this study is to establish diagnostic accuracy of the xTAG GPP.~   "
171082|NCT01326000|"~     This randomized, multicenter, open label study will evaluate the safety and efficacy of~     RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone~     as second line treatment in patients with metastatic colorectal cancer. Patients will be~     randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks~     thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on~     Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study~     treatment is until disease progression or unacceptable toxicity occurs.~   "
172238|NCT01310712|"~     Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and~     axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of~     Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.~   "
171083|NCT01325987|"~     Using a randomized, placebo-controlled trial design in subjects with vitamin D deficiency,~     the investigators propose to determine if vitamin D treatment improves glycemic control in~     vitamin D deficient subjects with T2DM. The investigators hypothesize that oral vitamin D~     treatment will improve glycemic control and ß-cell function in vitamin D deficient AA~     subjects with T2DM. The investigators further hypothesize that maintaining serum 25(OH)D~     concentrations above 20 ng/ml with oral supplementation of vitamin D will have additional~     glycemic control effects.~   "
171084|NCT01325974|"~     Background: Antigen-detecting rapid diagnostic tests (RDTs) for malaria provide the~     possibility of a parasite-based diagnosis in areas where good quality microscopy can not be~     achieved.~      P. falciparum tests targeting the histidine-rich protein (HRP2) antigen are generally more~     sensitive than tests targeting the Plasmodium lactate dehydrogenase (pLDH) antigen. However,~     as the HRP2 antigen is eliminated from the bloodstream more slowly than the pLDH antigen,~     HRP2-based tests can give a positive result two weeks or more after the patient has taken an~     effective treatment, while pLDH tests generally turn negative a few days after. The use of an~     RDT positive result in a routine patient care is therefore challenged by the interpretation~     of whether the result is due to a lasting effect of the already treated infection or to a new~     infection. The interpretation might also be affected by the level of malaria transmission in~     the area.~      Objective: The objective of this study is to estimate the proportion of positive tests in~     patients successfully treated for malaria (smear negative) at different time points in time~     after treatment, for three rapid diagnostic tests: SD Bioline Malaria Antigen P.f. (catalogue~     number: 05FK50-02-4), CareStart Malaria HRP2 (Pf) (catalogue number: G0141) and CareStart~     Malaria pLDH (PAN) (catalogue number: G0111). The study will be carried out in two settings~     with known low and high malaria transmission levels in order to provide guidance of~     interpretation of a RDT positive result depending on the intensity of malaria transmission.~      Secondary objectives will be to measure the sensitivity and specificity of the malaria rapid~     tests compared to smear microscopy, to estimate the median time to become negative for each~     of the tests and to estimate the proportion of positive tests and the median time to become~     negative according to the initial parasitaemia and the presence of gametocytes.~   "
171085|NCT01325961|"~     The aim of the study is a medico-economic evaluation to estimate a cost differential between~     three modalities of Intensity-Modulated Radiation Therapy for cancers of the prostate, cervix~     and anal canal with pelvic lymph node irradiation : treatment with helical Tomotherapy and~     dynamic arc therapy using two different technologies: RapidArc or VMAT.~   "
171086|NCT01325948|"~     The purpose of this study is to investigate the effects of Chronic Obstructive Pulmonary~     Disease (COPD) on daily life activities in patients with COPD and also to determine the~     socio-demographic profile, daily life style and needs of the patients with COPD.~   "
171087|NCT01325935|"~     A prospective multicenter registry in real-world Japanese patients undergoing DAPT for three~     months after stenting. To assess the long-term safety of Endeavor Zotarolimus-eluting stent~     through noninferiority in the primary endpoint between two different continuous regimen~     (three and twelve months) groups of DAPT after stenting with Endeavor Zotarolimus-eluting~     stent in real-world Japanese patients and to examine the optimal duration of DAPT after~     stenting with Endeavor Zotarolimus-eluting stent. The long-term DAPT group in the present~     clinical study (to be appropriated from the post-marketing surveillance of Endeavor) should~     consist of consecutive patients undergoing DAPT for twelve months after stenting, while the~     short-term DAPT group (to be newly registered in the present clinical study) should consist~     of patients who are instructed to undergo DAPT for three months after stenting.~   "
171088|NCT01325922|"~     Study Description The purpose of this study is to compare the defibrillation efficacy between~     the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead~     Integrity Check (HVLIC) impedance.~      Hypothesis The Tuned waveform reduces defibrillation thresholds (DFTs) when compared to the~     50/50% tilt waveform.~      Study Methods~        -  This is an acute, paired-sample, randomized (waveform testing sequence) study~        -  Patients are implanted with an Food and Drug Administration (FDA) approved St. Jude~          Medical (SJM) EpicTM+ DR/VR Implantable Cardioverter Defibrillator (or any other~          standard output ICD after Epic+) and defibrillation lead system.~        -  All study testing is completed at implant.~        -  Patients are randomized to begin DFT testing with either the 50/50% tilt or Tuned~          waveform.~        -  The HVLIC feature is used to measure the high voltage lead impedance and to program the~          Tuned and 50/50% tilt waveform pulse widths.~        -  The DFT is determined by an optimized binary search method that is designed to reduce~          the overall number of VF inductions to an average of 5.13 while maintaining very high~          resolution and accuracy.~        -  Total # of centers - 15 centers~        -  Sample size - 60 patients~   "
171089|NCT01325909|"~     Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and~     rectal) cancer is associated with improved survival, but also adversely affects physical~     fitness, potentially rendering patients unfit for major surgery or increasing the risk of~     adverse outcome (death and serious complications) after major surgery. The investigators have~     pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant~     chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators~     therefore propose a blinded, single centre, prospective interventional trial of patients~     undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.~      The investigators wish to explore various hypotheses:~        1. Is exercise intervention feasible and tolerable in this cohort of patients?~        2. Can fitness be improved using a structured, responsive exercise training programme~          (SRETP)?~        3. Can SRETP improve quality of life?~        4. Can SRETP improve physical activity?~        5. Can SRETP improve surgical outcome?~        6. Can physiological fitness and oncological outcome be matched to identify an optimal time~          for physiological recovery following NACRT prior to major surgery.~      The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30~     patients for an interventional study over 24 months from Aintree University Teaching~     Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed~     to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary~     exercise test (CPET) and VO2 Kinetics tests, all done pre−CRT and at 3,6,9 and 14 weeks~     post−CRT (pre−surgery). All patients will have their CPET, as well as standard restaging~     scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be~     collected.~   "
171090|NCT01325896|"~     -  Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic~          malignancies. Between 50 and 70% of symptomatic patients presented response to induction~          chemotherapy. The rate of complete responses (CR) achieved with standard induction of~          these treatments is less than 5% of cases and the median event-free survival between 2~          and 3 years although most of the patients died from the disease.~        -  High dose chemotherapy with autologous stem cell transplant has improved the response~          rate and survival of patient with MM. However eventually all patients relapse with a~          median EFS between 40-50 months post-transplant.~        -  To improve these results and sustain remission, various maintenance treatment have been~          proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits~          in a meta-analysis.~        -  Intron A s.c. need administration of 3 days per week and is not well tolerated~        -  Recently a new formulation of Interpheron alpha2b is available. Conjugated with~          polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in~          MM.~        -  The purpose of this study is to evaluate the role of Pegintron as maintenance after~          autologous transplant in MM~   "
171091|NCT01325883|"~     Neoadjuvant chemotherapy (NAC) prior to surgery for upper gastrointestinal (oesophageal and~     gastric) cancer is associated with improved survival. The investigators propose a prospective~     blinded observational cohort study of patients undergoing NAC prior to elective upper~     gastrointestinal cancer resection (oesophagectomy and gastrectomy) in three NHS teaching~     hospitals. The investigators have pilot data showing that NAC reduces objectively measured~     exercise capacity (fitness). The literature suggests that a lower level of exercise capacity~     is associated with a high risk of adverse outcome (death and serious complications) after~     major surgery.~      The investigators wish to explore the hypothesis that decrease in exercise capacity (fitness)~     associated with (NAC) prior to upper gastrointestinal cancer resection may outweigh the~     benefits (duration of survival) achieved by NAC in some patients undergoing upper~     gastrointestinal cancer surgery. The investigators aim to recruit 175 patients from over 36~     months. Consenting patients will perform cardiopulmonary exercise testing (CPET) and complete~     a quality of life questionnaire prior to and 4 weeks after NAC . Postoperative outcomes~     measured at set time points will be objective recorded including mortality 1 year after~     surgery and short term postoperative harm described by the PostOperative Morbidity Survey~     (POMS) as well as Quality of life scores and resource use (e.g. hospital bed utilisation).~     Exercise capacity (fitness) before and after NAC will be assessed using CPET and the~     relationship between the derived variables (AT, VO2 peak) and clinical outcomes will be~     described.~   "
171092|NCT01325870|"~     More than 300,000 Americans experience out-of-hospital cardiac arrest annually, with overall~     survival rates averaging less than 5%. Low survival rates persist, in part, because manual~     chest compressions and ventilation, termed standard cardiopulmonary resuscitation (S-CPR), is~     an inherently inefficient process, providing less than 25% of normal blood flow to the heart~     and the brain. Hemodynamics are often compromised further by poor S-CPR techniques,~     especially inadequate chest compression and incomplete chest recoil. Active Compression~     Decompression CPR (ACD-CPR) is performed with a hand-held device that is attached to the~     patient's chest, and also includes a handle containing a metronome and force gauge to guide~     proper compression rate, depth and complete chest wall recoil. The impedance threshold device~     (ITD) is designed for rapid connection to an airway adjunct (e.g. facemask or endotracheal~     tube) and allows for positive pressure ventilation, while also impeding passive inspiratory~     gas exchange during chest wall decompression. Prior studies have shown that the combination~     of ACD-CPR + ITD enhances refilling of the heart after each compression by augmenting~     negative intrathoracic pressure during the decompression phase of CPR, resulting in improved~     cardiac and cerebral perfusion. The intrathoracic pressure regulator (ITPR) is a next~     generation inspiratory impedance therapy. The ITPR uses a regulated external vacuum source to~     lower the negative intrathoracic pressure and is therefore less dependent on the quality of~     CPR (e.g., completeness of chest wall recoil). The ITPR generates a pre-set continuous and~     controlled expiratory phase negative intrathoracic pressure that is interrupted only when~     positive pressure ventilation is needed to maintain oxygenation and provide gas exchange.~      The purpose of the study is to compare the early safety and hemodynamic effects of S-CPR,~     ACD- CPR + ITD, and S-CPR + ITPR in patients with out-of-hospital cardiac arrest.~   "
171093|NCT01325857|"~     This study was designed to investigate the analgesic effect of bilateral superficial cervical~     plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The~     investigators hypothesized that bilateral superficial cervical plexus blockade would reduce~     the patient's pain score by more than 10 (on a VAS scale of 0~100) compared to a placebo~     group and control group.~   "
171094|NCT01325844|"~     This study was designed to investigate the effects of epidural anesthesia combined with~     general anesthesia during laparoscopic surgery. The investigators hypothesized that epidural~     anesthesia will effectively block the activation of the sympathetic nervous system during~     surgery, thus activating nitric oxide and reducing splanchnic ischemia and decrease in~     postoperative renal function.~   "
171095|NCT01325831|"~     In order to explore the effect of repetitive TMS, which has shown to be effective in~     intractable depression, we will examine resting-state, default-mode network functional~     connectivity in patients with major depression. We will use a double-blind, sham-controlled~     design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30~     will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral~     prefrontal cortex of the subjects.~   "
171096|NCT01325818|"~     The purpose of this study is to compare the effects of pravastatin and rosuvastatin on~     coronary plaque characteristics in patients with stable angina pectoris.~   "
171097|NCT01325805|"~     Overweight and obesity has been associated with a number of adverse pregnancy outcomes in~     women of reproductive age, including infertility and early pregnancy loss. Recent data~     suggests that overweight and obese patients are also at increased risk of recurrent pregnancy~     loss (RPL), a devastating condition that affects 1% of the fertile population.~      The investigators propose a prospective, randomized controlled trial in which overweight and~     obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6~     month, weight loss program or provided routine counseling regarding the importance of weight~     loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic~     outcomes, such as lipid and glucose profiles, will also be evaluated.~   "
171098|NCT01325792|"~     Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue~     Reinforcement when used to reinforce midline fascial closure in single-staged open complex~     ventral incisional hernia repair.~   "
171099|NCT01325779|"~     Study hypothesis: Subcutaneous enoxaparin is more effective than subcutaneous heparin in~     preventing the development of DVT in the general surgical intensive care unit population.~      Hospitalized patients are at increased risk for the development of blood clots in the legs,~     known as deep venous thrombosis (DVT). Surgical patients are in a higher risk category than~     the general hospital population due to a number of factors including undergoing surgery and~     increased risk of immobility. The highest risk patients are in the surgical intensive care~     unit, where their surgical risks for blood clots are combined with issues such as sepsis,~     acquired blood clotting disorders, and increasing age, each of which are factors that~     contribute to the risk of blood clot development. 1. Patients who develop these blood clots~     (DVTs) are at risk for chronic leg swelling, pain, and in some cases, chronic ulcer~     development on the leg. In the worst case scenario, these blood clots can break away and~     migrate to the lungs where they cause a pulmonary embolism (PE), a clot in the lungs that can~     cause significant breathing difficulty requiring intubation and mechanical ventilation, and~     in some cases, death.~      According to recent research, DVTs account for over 200,000 patient deaths each year~     nationwide. 2. A large amount of data has supported the use of medication called heparin or~     enoxaparin in low doses to prevent these blood clots from forming while in the hospital. Both~     of these medications are considered standard of care for use patients considered moderate and~     high risk for the development of DVT. 3. While both of these medications have been shown to~     significantly reduce the occurrence of DVT in appropriate doses, 4. there has never been a~     direct comparison of the two medications in the highest-risk population of the surgical~     intensive care unit. Our own preliminary data suggests patients may have a lower incidence of~     DVTs with the use of enoxaparin versus heparin. Part of the reason for this may be the~     requirement for three times daily dosing of the heparin compared to once daily dosing for~     enoxaparin. There may also be some inherent differences in the efficacy of the medications~     themselves.~   "
171140|NCT01325246|"~     The risk for recurrence after ventral hernia repair is often based on reoperation rates with~     short follow-up rather than recurrences identified by clinical examinations.~      The purpose of current study is find the real incidence of recurrences 3 years after ventral~     hernia repair and to compare with the reoperation rate.~   "
171100|NCT01325766|"~     Cystic fibrosis (CF) is a lung disease that affects 30,000 children and adults in the US.~     Incorporation of regular exercise into the lives of patients with CF is of interest because~     it may improve lung function and quality of life. Yoga is an activity that may benefit~     patients with CF in many ways including strengthening muscles of breathing, improving lung~     function, and reducing stress which could improve quality of life and adherence to therapies.~     Yoga has been shown to be beneficial in patients with other lung diseases such as asthma, but~     has not yet been studied in CF.~      The investigators hypothesize that yoga will be an activity that is safe and tolerable for CF~     patients 12 to 25 years of age. The primary aim is to investigate the safety and tolerability~     of an 8 week yoga program for patients with CF. The secondary aim is to determine the effect~     of yoga on many aspects of CF disease including respiratory symptoms, adherence to regular CF~     therapies, quality of life, lung function, exercise tolerance, and nutritional status.~      The long-term goal is to use the data obtained in this study to design a future study of the~     efficacy of yoga in a larger population of CF patients at multiple CF centers. This research~     has the potential to influence the prevention and treatment of CF by providing data which~     could be used to help understand the most appropriate and beneficial type of physical~     activity for CF patients.~   "
171101|NCT01325753|"~     This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in~     treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.~   "
171102|NCT01325740|"~     The study will consist of a Screening period (up to 14 days), a Treatment period, and a~     Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or~     30 mg (or matching placebo) across four study centers.~   "
171103|NCT01325727|"~     The purpose of this research study is to find out more about smokers in recovery from~     addiction to alcohol/other drugs, and to evaluate a brief computerized smoking behavior~     feedback session. The hypothesis is that a brief computerized smoking behavior feedback~     session will motivate more smokers to quit smoking than a control condition.~   "
171104|NCT01325714|"~     This study tests whether education about memory and pain might help to prevent aggression in~     persons with dementia who have pain. The overall goal of this intervention is to reduce the~     risk of aggressive behavior by improving several areas of patient life that are known causes~     of aggression: pain, depression, lack of pleasurable activities, caregiver stress and~     difficulty in caregiver-patient communication.~   "
171105|NCT01325701|"~     The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in~     relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse~     Large B-cell Lymphoma (DLBCL).~   "
171106|NCT01325688|"~     This study is primarily designed to investigate whether treatment, once daily for up to three~     consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in~     patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.~   "
171107|NCT01325675|"~     The purpose of this study is to determine the effect of aerobic interval training in patients~     with paroxysmal or persistent atrial fibrillation, especially to see if the burden of atrial~     fibrillation and symptoms are reduced.~   "
171108|NCT01325662|"~     This is a study to evaluate the feasibility and tolerability of low-rate continuous~     Cerebrospinal Fluid (CSF) sampling and to estimate the number of participants who exhibit~     severe baseline instability of CSF amyloid beta isoform Aß40 concentrations in healthy~     participants.~   "
171109|NCT01325649|"~     The objective of the study is to provide proof that a MRI based preoperative~     radiochemotherapy in patients with locally advanced rectal carcinoma allows limiting RCT to~     high risk patients without increase of locoregional recurrence rate and decrease of overall~     survival provided there is a high quality of mesorectal excision.~   "
171110|NCT01325636|"~     The main purpose of this project is to evaluate the efficiency of the injection of CD4 and~     CD8+ T cell anti-Cytomegalovirus (CMV) on blood viral replication of CMV, 21 days after the~     first injection (adenovirus infection is not enough usual, especially in adults, to be used~     for the primary purpose and is measured in the secondary endpoints).~   "
171111|NCT01325623|"~     The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model~     106 VNS Therapy System.~   "
171112|NCT01325610|"~     The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That~     has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD)~     (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone~     release in compensation). Replacing 1,25 D directly has been the goal with using 1,25D or its~     analogues in CKD. There is very little data concerning use of native vitamin D or 25(OH)D in~     CKD, although autocrine functions in extrarenal tissues would use 25(OH)D. The latest KDIGO~     guidelines do recognize the autocrine role of vitamin D, but have no data on outcomes or~     doses or optimal levels to guide them and so have made a blanket recommendation to treat 25D~     levels in CKD by general healthy population guidelines.~        1. This project focuses on an outcome (calcium absorption) that may be impacted by~          optimizing 25D status in renal patients. The investigators will assume for this project~          that a level of 25D > 32 ng/ml is optimal in CKD patients as in a healthy population.~        2. A secondary outcome is to quantify calcium absorption in CKD patients with and without~          vitamin D repletion and to quantify systemic 1,25D levels. This may clarify the roles~          25D and 1,25D play in calcium absorption.~   "
171113|NCT01325597|"~     The purpose of this study is to assess the effects of functional electrical stimulation~     associated with inspiratory muscle training on functional capacity and quality of life in~     heart failure patients.~   "
171114|NCT01325584|"~     The purposes of this study are to make Omegaven® available to cancer patients with liver~     disease and to determine if Omegaven® can improve or prevent further liver disease. The study~     will also look at the effects Omegaven® has on immune function.~   "
171115|NCT01325571|"~     To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis~     who are inadequately treated by glucocorticoid.~   "
171166|NCT01324908|"~     This clinical trial studies biomarkers in predicting response in patients with~     graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats~     the patient's blood with ultraviolet light outside the body and kills the white blood cells~     before returning blood back into the patient's body. Studying samples of blood from patients~     with GVHD may help doctors identify and learn more about biomarkers related to GVHD.~   "
171116|NCT01325558|"~     This is a Phase I, open-label, multi-center, competitive enrollment and dose-escalation study~     of ALT-836 in combination with standard of care gemcitabine in participants who have locally~     advanced or metastatic solid tumors. The purpose of this study is to determine the maximum~     tolerated dose (MTD), and to assess the safety and pharmacokinetic profile of ALT-836 given~     with gemcitabine. The clinical benefit, progression-free survival and overall survival of~     study participants will also be assessed.~   "
171117|NCT01325545|"~     About one-third of patients with stroke have no documented cause for the cerebrovascular~     event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but~     when transient (paroxysmal) it may remain undiagnosed. Recent data suggest that occult~     paroxysmal atrial fibrillation may be identified in patients with cryptogenic strokes using~     prolonged ambulatory cardiac rhythm monitors.~      The investigators designed this study pursuing the following goals:~        1. To determine the prevalence of occult paroxysmal atrial fibrillation in patients with~          cryptogenic stroke using long-term mobile cardiac outpatient telemetry.~        2. To compare this prevalence to that found in a control group with stroke of known,~          non-cardioembolic cause.~        3. To look for clinical, laboratory, echocardiographic, and imaging data that serve as risk~          factors for occult paroxysmal atrial fibrillation in patients with cryptogenic stroke.~        4. To examine the utility of mobile cardiac outpatient telemetry, a relatively new~          diagnostic tool, in the evaluation of patients with cryptogenic stroke.~   "
171118|NCT01325532|"~     The purpose of this study is to see if using Cranial Electrical Stimulation (CES) helps~     improve symptoms of major depressive disorder (MDD). The investigators are studying the~     device's effectiveness in treating depression, as well as its safety. This is a pilot study.~      Eligible participants will be randomly assigned to receive either active CES or sham CES,~     every weekday for 3 weeks. During the visits, subjects will receive CES or sham CES treatment~     for 20 minutes.~      The primary outcome measure will be change in score on the HAM-D 17. The secondary outcome~     measure will be change in patient-reported sleep score.~   "
171119|NCT01325519|"~     The purpose of this study is to compare the decision making of hospitalized subjects having a~     verbal discussion about CPR compared to subjects using a video.~   "
171120|NCT01325506|"~     Prostate cancer is the most common cancer in American men. Surgical removal of the entire~     prostate (prostatectomy) is one option among the various ways to treat prostate cancer. The~     use of robot assistance for prostatectomy has become common place, but its effectiveness has~     not been compared to standard open prostatectomy in trials carried out at more than one~     medical institution in which participants are identified and followed forward in time. Robot~     assisted and standard open prostatectomy health related quality of life (HRQOL) outcomes have~     not been compared in a prospective, multi-centered study. Prostatectomy can have side effects~     that can change with time. This research study seeks to determine how common and how~     long-lasting such side effects are; to find out what features of individual men's cancers and~     what features of the treatments affect those side effects. This study also seeks to identify~     factors that affect the quality of prostate cancer care by looking at how satisfied men are~     with their prostate cancer care. Through these findings, this study aims to allow treatment~     side effects to be anticipated more accurately for individual patients, and to provide a~     means for determining the quality of prostate care.~   "
171121|NCT01325493|"~     The purpose of this study is to:~      1. Establish whether ketamine can decrease opioid consumption and modulate the onset of~     opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years~     to 18 years, undergoing posterior spinal fusion and instrumentation.~   "
171122|NCT01325480|"~     The purpose of this acute study is to perform a preliminary investigation of high septal~     right ventricular pacing in the vicinity of the His bundle region as an alternate or~     adjunctive means for cardiac resynchronization in patients with heart failure and wide QRS.~   "
171123|NCT01325467|"~     This will be a registry study that will enroll patients referred for an ECG treadmill test~     with nuclear myocardial perfusion imaging (MPI). The high frequency QRS (HFQRS) information~     will be recorded and analyzed automatically and simultaneous with the standard ECG signals by~     the HyperQ System. Results of subsequent tests performed on each patient will be collected~     and used to enhance the reliability of designating each patient as a CAD-negative (i.e., no~     significant coronary artery disease) or a CAD-positive (i.e., significant coronary artery~     disease).~   "
171124|NCT01325454|"~     Angiogenesis is a key process in the formation of exudative pleural effusions. Fluid~     loculation is common in parapneumonic effusion and is associated with depressed pleural~     fibrinolytic activity and poor clinical outcome. However, the relationship between angiogenic~     cytokines and fibrinolytic activity in the pleural space remains unclear. The researchers's~     hypothesis is that the levels of angiogenic cytokines were increased and associated with~     decreased fibrinolytic activity in parapneumonic effusions which may contribute to fibrin~     deposition and fluid loculation in the pleural space.~   "
171125|NCT01325441|"~     This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608~     in combination with paclitaxel in patients with advanced malignancies.~   "
171126|NCT01325428|"~     The general aim of this study is to investigate the efficacy and safety of afatinib alone and~     in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy~     within this trial) as treatment in patients with HER2-overexpressing, locally advanced or~     metastatic inflammatory breast cancer. The study will include patients who have and have not~     failed prior trastuzumab treatment.~   "
171127|NCT01325415|"~     The purpose of this study is to evaluate the effects on QTc interval in healthy males when~     administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a~     specific time interval that can be measured in a heart beat by taking Electrocardiogram~     (ECG))~   "
171128|NCT01325402|"~     In this study different mass of the radioligand AZD4694 will be given to patients with~     Alzheimer's Disease and healthy volunteers to evaluate wich Mass of AZD4694 that gives the~     best opportunities for following disease progress and treatment effects.~   "
171191|NCT01324583|"~     Primary Objective:~        -  To assess the tolerability at global doses~      Secondary Objectives:~        -  Safety~        -  Pharmacokinetics~        -  Efficacy~   "
171192|NCT01324570|"~     The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients~     of ages 7 to 16 years.~   "
171129|NCT01325389|"~     Menopause is the milestone of a more broaden condition that can last up to 10 years. The~     first menopausal symptoms usually appear around the age of 42 and are characterized by a~     gradual decline in thyroid and gonadal function with a progressive increase of plasmatic~     luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels.~      Recent studies have shown that myo-inositol and melatonin play a major role in ovarian~     homeostasis. In particular, it has been demonstrated that myo-inositol and/or melatonin~     supplementation lead to an increase of oocyte quality.~      Additional studies focused on postmenopausal women have shown that myo-inositol is able to~     ameliorate the metabolic syndrome that often affects these patients, thus reducing the risk~     of cardiovascular diseases (CVDs).~      The aim of the present study is to evaluate whether myo-inositol and melatonin might play a~     positive role in regulating hormonal levels during menopausal onset.~   "
171130|NCT01325376|"~     This is a six month lifestyle management study to compare the effects of iWell; a dynamic~     online interactive technology to a self-directed program in overweight or obese individuals.~      The primary aim is to test the hypothesis that dynamic online interactive technology~     intervention is more effective than self-directed program in obtaining and maintaining weight~     loss and other biometric improvements.~   "
171131|NCT01325363|"~     The aim of this research is to investigate the neurolinguistic mechanisms underlying thought~     disorders among schizophrenic patients. In particular, it will investigate the~     neurolinguistic basis for loose association - a phenomena which this population is~     characterized by. Several researchers have previously suggested that loose associations among~     schizophrenic patients relate to a lack of inhibition in the automatic spread of activation~     mechanisms within semantic networks (e.g., Soriano, Jimenez, Roman, & Bajo, 2008). This~     research focuses on the relationship between I. the left-right hemisphere dynamic and II.~     semantic processing, among schizophrenic patients. The research follows Jung-Beeman's (2005)~     model which relates semantic associations, activation and inhibition processes to the~     functioning of the two cerebral hemispheres.~      Previous research suggests that, when compared to the neurotypical population, people with~     schizophrenia show a less defined - or even reversed - hemispheric lateralization pattern for~     semantic processing. This is linked to an impairment in language function in the left~     hemisphere, and to a language functions shift from left to right hemisphere (e.g., Crow,~     1997). The investigators assume that this unique lateralization pattern may cause a change in~     balance in the semantic activation and inhibition system among schizophrenic patients.~      As stated, one of the linguistic models that predicts how reduced left hemisphere dominancy~     will influence linguistic functioning is Jung-Beeman's (2005) bilateral model for language~     understanding. According to this model, the left hemisphere specializes in precise and fine~     semantic processing, while the right hemisphere specializes in coarse and abstract semantic~     processing. Building upon this distinction, our assumption is that schizophrenic patients~     experience a difficulty in fine semantic processing which is caused by functional impairment~     in the left hemisphere. It is our further assumption that coarse semantic processing -~     located in the right hemisphere - is relatively unimpaired. This change in the balance~     between the two processes may have direct implications on the associative semantic network~     among schizophrenic patients.~      In order to test this hypothesis, the current research will make use of a specific language~     expression type which involves fine and coarse semantic processing, and for which there is~     evidence for crucial right hemisphere involvement: novel metaphor processing. 10-20 adult~     schizophrenic patients will be presented with four different types of two word expressions:~     literal; conventional metaphor; novel metaphor and unrelated. The patients will have to~     decide as quickly and accurately as possible if the expression is meaningful or meaningless~     while their brain activity is recorded by a Magnetoencephalographic (MEG) device (which~     combines a high temporal resolution with the ability to localize the activity).~      Therefore, our main hypothesis is that schizophrenic patients will show a bilateral brain~     activity pattern when conducting semantic decisions, and that this pattern will be related to~     improved reaction times and accuracy when presented with novel metaphors than when presented~     with other types of expressions.~   "
171132|NCT01325350|"~     This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared~     with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern~     hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil~     2% solution which will be provided open-label.~   "
171133|NCT01325337|"~     This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared~     with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic~     alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5%~     solution which will be provided open-label.~   "
171134|NCT01325324|"~     In different cases intraocular pressure (IOP) have to measured in lying position. Therefore a~     lot of portable tonometers have been established. The Icare Pro is a new tonometer on the~     market that allows faster and more comfortable IOP-measurements. No local anesthesia is~     needed, what is a major advantage for the patients. In this study the investigators want to~     evaluate if IOP measurements with Icare Pro Tonometer are as reliable as they are with other~     established portable tonometers (Perkins, TONO-Pen and hand held-Dynamic Contour Tonometer).~        -  Trial with medical device~   "
171135|NCT01325311|"~     This randomized phase II trial studies cholecalciferol and genistein compared to placebo in~     treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow~     the growth of cancer cells and may be an effective treatment for prostate cancer.~   "
171136|NCT01325298|"~     The primary objective of this study is to evaluate two different ultraviolet (UV) dosing~     regimens for corneal collagen cross linking to slow the progressive changes in corneal~     curvature in eyes with progressive keratoconus or post-refractive surgery ectasia.~   "
171137|NCT01325285|"~     The purpose of this study is to determine how intraocular pressure responds to changes in the~     levels of carbon dioxide or oxygen that a healthy individual inspires.~   "
171138|NCT01325272|"~     To verify the occurrence of Spontaneous Otoacoustic Emissions (SOAE) in neonates at term and~     preterm infants who had transient otoacoustic emissions and verify if the presence of~     response is related to gestational age, gender or risk factors for hearing loss.~   "
171139|NCT01325259|"~     Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a~     major matter of concern. There is now an important body of literature stating that early~     isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing~     AD. Several biomarkers are now available : specific and sensitive neuropsychological~     assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI,~     cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain~     glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging~     using labelled compounds specifically binding to APs has been suggested to improve the~     diagnostic reliability and to potentially help in shortening the delay until formal clinical~     diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15~     minutes acquisition 50 to 60 minutes post injection.~      Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD,~     MCI patients and Healthy Controls.~      Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will~     have convert toward dementia versus those who will not, at two year follow-up period, to~     compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG~     hypometabolism, ApoE genotype.~      Method: Prospective multicentric study. 65 patients expected to enter the study.~      Primary outcome measure: Standard Uptake Volume ratios.~   "
175169|NCT01272271|"~     This retrospective chart review study compares the incidence of corneal inflammation due to~     infection in children vs. adult patients wearing overnight corneal reshaping lenses.~   "
171141|NCT01325233|"~     Astragalus membranaceus (AM) is used to treat stroke for a long time, and a number of studies~     have shown that AM can reduce cerebral infarction area and has anti-oxidation activity. PG2,~     a sterile powder of polysaccharides isolated from the root of astragulus (Huang-Chi) for~     intravenous injection, has been approved as a botanical drug by TFDA. Hemorrhagic stroke will~     induce secondary peri-blood clot edema and that may increase intracranial pressure to~     exacerbate clinical symptom. Therefore, the purpose of the present study was to investigate~     the efficacy of PG2 on hemorrhagic stroke.~   "
171142|NCT01325220|"~     There will be four study periods: Screening (up to 14 days in length), the Treatment Period~     (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects~     will be randomized to receive either STX209 (5 mg twice daily [BID], 10 mg BID or 10 mg three~     times daily [TID]) or placebo. Efficacy,safety and tolerability assessments will be performed~     periodically~   "
171143|NCT01325207|"~     The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of~     cancerous tumors that are HER-2 positive. Patients are being asked to participate in this~     study because they have been diagnosed with having tumor cells in their spinal fluid. This~     study will investigate the safety and effects of this drug when given directly into the~     spinal fluid.~      Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the~     Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer The purpose of this~     research study is to determine a safe dose of the drug Trastuzumab and then determine how~     effective this treatment is.~   "
171144|NCT01325194|"~     The purpose is to test whether early central nervous system (CNS) prophylaxis given at the~     beginning of therapy for young high risk diffuse large B-cell lymphoma (DLBCL) patients is~     feasible and could reduce the risk of CNS relapses. Early CNS prophylaxis with two courses~     high dose methotrexate (HD-MTX) in combination with~     rituximab-cyclophosphamide-doxorubicin-vincristine-prednison (R-CHOP) is followed by four~     courses of R-CHOP14 and etoposide (E) and one course of HD-Ara-C. In addition the patients~     will receive three courses of liposomal cytarabine intrathecally. The results will be~     compared to a recent Nordic CRY-04 study. Shifting of CNS prophylaxis to the beginning of the~     therapy offers a potential to overcome the subclinical disease and thus reduce the risk of~     early clinical CNS recurrence. As flow cytometry (FCM) can improve the sensitivity for~     detecting occult leptomeningeal disease over cytology , FCM from cerebrospinal fluid will be~     incorporated into the staging procedures.~   "
171145|NCT01325181|"~     The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab~     injection versus low-fluence PDT in the treatment of chronic CSC.~   "
171146|NCT01325168|"~     Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the~     hypothalamus - is a key mediator of complex social and affective behaviors, including~     emotional empathy. Recently, several theoretical studies suggested that PTSD patients have~     abnormal functioning of the OT system. According to these theories, dysfunction in the~     oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and~     therefore intranasal OT may potentially relieve these symptoms. The main goal of this study~     is to examine the effects of administration of nasal OT on empathic abilities among PTSD~     patients. Another goal of this study is to examine the relationship between empathic~     abilities and the ability to retrieve autobiographical memories among PTSD patients.~   "
171147|NCT01325155|"~     The association between exposure to ambient air pollution and pulmonary disease has been well~     established.To date no study has assessed the burden of cardiovascular disease in Israel and~     its relation to ambient air pollution.~      The Haifa Bay Area has a long history of industrialization including possessing the nation's~     largest oil refineries, oil-fired power plant, agrochemical and cement producers, industrial~     incinerators and the Eastern Mediterranean's busiest port. The presence of industrial and~     mobile sources, combined with a basin effect has contributed to air pollution in the Haifa~     Bay Area and has raised concerns about potential health effects.~      Research Objectives~        -  Determine if the increased rate of cardiovascular mortality in Haifa is associated with~          PM 2.5 concentrations.~        -  Assess effect modification in diverse sub-populations.~        -  If an association does exist, assess the economic burden of PM 2.5 associated~          cardiovascular morbidity and mortality.~        -  Design prediction models of daily cardiovascular emergency department visits based on~          daily and seasonal variation of air pollution.~   "
171148|NCT01325142|"~     This study seeks to identify risk factors associated with the development of a jaw condition~     seen in patients with cancer treated with certain medications.~   "
171149|NCT01325129|"~     Most Clavicular Fractures in Children can be Treated Conservatively. Our Own Study showed a~     Benefit towards Much Lower Pain and Better Cosmesis in Adolescents when Treated with Elastic~     Stable Intramedullary Nailing.~      The First 20 Patients Treated with this Method will be examined for Functional (CONSTANT and~     MURLEY-Score) and Cosmetic Results as well as Ultrasound-Morphology of both clavicles and~     Patients`satisfaction (CSS-8). Further on, all complications and problems will be documented.~   "
171150|NCT01325116|"~     ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack~     constituting approximately 30% of all cases. Clinical guidelines around the world support the~     prolonged use of secondary preventative medications including aspirin, clopidogrel, statin,~     beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and~     discharge prescription rates are excellent, adherence to these essential life-saving~     medications is far less than ideal, even a few months following hospital discharge. The~     investigators plan to capitalize on the existing structure of the SMART-AMI project already~     underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on~     behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months~     post-discharge, reviewing the evidence for life-saving cardiac medications and urging~     long-term adherence to secondary preventative cardiac medications. This will be sent to the~     family physician and the patient, using audience-appropriate language. If the DERLA-STEMI~     project is accepted by physicians and patients, found to be both feasible and effective, then~     this simple and low-cost intervention will be studied in all patients with an abnormal~     coronary angiogram.~   "
171151|NCT01325103|"~     This research investigates the use of autologous bone marrow stem cells in patients with~     spinal cord injury.~   "
171152|NCT01325090|"~     Botulinum toxin type A has been reported to inhibit the release of various pain~     neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process~     that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This~     action is probably responsible for the analgesic effect of botulinum toxin type A recently~     demonstrated in patients with neuropathic pain of peripheral origin.In those studies,~     patients had been suffering for years. The investigators can hypothesizes that earlier~     administration of Botox in the course of neuropathic pain might prevent central~     sensitization, that is secondary to peripheral sensitization. The investigators can hope to~     increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.~   "
171153|NCT01325077|"~     Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain~     in pediatric patients?~   "
171154|NCT01325064|"~     Background: The purpose of this study is to analyze the relationship between central and~     peripheral blood pressure (clinic and ambulatory) with vascular structure and function,~     assessed by carotid intima-media thickness (IMT), artery venous retinal index, pulse wave~     velocity (PWV) and ankle-brachial index in patients with diabetes type 2 and without diabetes~     type 2. Develop and validate a software to measure the retinal vessels and to estimate~     arterio-venous index automatically.~      Methods/design: The investigators will Perform a coss-sectional study with control group,~     with follow-up of 4 years in primary care. The study population will be diabetic type 2~     patients with a control group without diabetes mellitus. The investigators will include by~     consecutive sampling 300 patients between 34 and 75 and without previous cardiovascular~     disease, half of each group. Main measurements: age, sex, height, weight and waist~     circumference. Lipids, creatinine, microalbuminuria, blood glucose, HbA1C, insulin,~     fibrinogen, hs-CRP and markers of endothelial dysfunction. Clinic and ambulatory blood~     pressure (MAPA). Ultrasonography to assess carotid IMT, retinography to assess arterio-venous~     ratio. ECG to evaluate left ventricular hypertrophy, ankle-brachial index and morphology~     analysis (PWA) and pulse wave velocity (PWV) in Sphigmocor System.~      Discussion: The investigators provide information regarding various parameters derived from~     MAPA and pulse wave analysis of with target organ damage, especially with the vascular~     structure and function assessed by IMT and PWV and endothelial dysfunction in patients with~     diabetes type 2 and without this disease. The investigators also hope to demonstrate the~     usefulness of the tool developed for automatic evaluation of retinal vascularization in the~     early detection of abnormalities of vascular structure and function and the prognosis of~     cardiovascular disease in the medium term.~   "
171155|NCT01325051|"~     The purpose of this study is to characterize the way the first commercially available~     integrase inhibitor, raltegravir, a new class of antiretrovirals that is used to treat HIV,~     is distributed into the rectal mucosal tissue. This information will generate important~     information regarding the drug's penetration into lymphoid tissues that are rapidly depleted~     in HIV infection. Subsequently strategies to prevent the sexual transmission of HIV and for~     treating HIV-infected individuals will be designed.~   "
171156|NCT01325038|"~     Healthy males are randomized to isometric exercise for three months with either extra protein~     or extra calories in the form of a fast food meal/day in order to study if increase in muscle~     mass increases resting metabolic rate and if this is affected by presumed increased caloric~     intake as compared with only proteins.~      Body-composition was measured with Dual-Energy X-ray Absorbimetry (DEXA) and RMR was measured~     by registration of CO2 production and O2 consumption.~   "
171157|NCT01325025|"~     High-field MRI and diffusion tensor imaging with 3D reconstruction of the myelin tracks, in~     combination with multivoxel proton spectroscopy, will allow to precise more accurately the~     evolution of the white matter lesions in patients affected with Metachromatic Leukodystrophy~     (particularly in the initial phase of the disease). This will increase the knowledge of the~     disease and provide new indicators for the selection and evaluation of patients eligible for~     new therapeutic approaches.~   "
171158|NCT01325012|"~     To determine the relationship between perineural catheter location along the sciatic nerve~     (popliteal versus subgluteal placement) and infusion effects for ultrasound-guided continuous~     sciatic nerve blocks.~   "
171159|NCT01324999|"~     This study is designed to assess safety and efficacy of tadalafil in patients with~     Sarcoidosis Associated Pulmonary Hypertension.~      Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients~     with Sarcoidosis~   "
171160|NCT01324986|"~     Available data regarding the effectiveness of laparoscopic antireflux surgery on~     extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly~     controversial. The aim of the present study was to evaluate the clinical effect of partial~     and total fundoplication on extraesophageal symptoms in a selected cohort of patients with~     GERD.~   "
171161|NCT01324973|"~     Obesity and physical inactivity have become serious problems for individuals with mental~     illness, resulting in increased rates of chronic disease, premature death, and substantial~     health care costs. Although in-person psychoeducational interventions help individuals with~     mental illness manage their weight, these interventions are often not used because they~     require frequent travel to treatment programs and substantial time from clinicians. This~     project addresses these barriers by developing and evaluating the effectiveness of an~     web-based computer system that is focused on diet and exercise education, and designed to~     help individuals with mental illness manage their weight.~   "
171162|NCT01324960|"~     A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and~     tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who~     achieved a hematological response after 6 cycles of azacitidine. After approval by an~     independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an~     open label randomized phase II study designed to characterize the efficacy, safety, and~     tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher~     risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of~     azacitidine.~   "
171163|NCT01324947|"~     The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy~     in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in~     study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone~     due to disease progression.~   "
171164|NCT01324934|"~     The main objective of the study is the assessment of the overall graft rejection rate (acute,~     chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to~     standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a~     treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year~     after renal transplantation.~   "
171165|NCT01324921|"~     To compare the postprandial glycemic and insulinemic response of subjects with type 2~     diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance~     test (MTT).~   "
171167|NCT01324895|"~     The objective of this study is to compare the efficacy of prokinetics versus antibiotics~     versus a combination of antibiotics plus prokinetics in the eradication of Small-Intestinal~     Bacterial Over-Growth Syndrome (SIBO) in those with and without a positive D-xylose Breath~     Test.~      Hypothesis: Patients with SIBO treated with a combination of prokinetics and in particular~     octreotide and antibiotics will have reduced recurrence rates of SIBO than either therapy~     given alone.~   "
171168|NCT01324882|"~     This research study is about determining how well a Technically Improved Colonoscope from~     Olympus works in helping the doctor in guiding the scope through the large bowel or colon.~     When a doctor performs a colonoscopy he guides or inserts the scope from the rectum to the~     appendix where the small bowel ends and the large bowel begins. There are points during this~     insertion where there are turns in the colon which can create a loop in the colonoscope.~     These loops can stretch the colon and create some discomfort and also require special~     maneuvers by the nurse or patient to help reduce or minimize the loop. Thus, reducing the~     looping will make it more comfortable for the patient and more efficient for screening for~     polyps. The purpose of the study is to examine this colonoscope and compare it to the~     traditional adult colonoscope (Olympus CF-H180). The investigators hypothesis is that this~     colonoscope will function better with regard to insertion of the scope from the rectum to the~     cecum.~   "
171169|NCT01324869|"~     This study is designed to access the safety and efficacy of multiple injections of KH902 in~     patients with Diabetic Macular Edema (DME).~   "
171170|NCT01324856|"~     Pancreaticoduodenectomy is the standards surgical procedure for various malignant and benign~     disease of the pancreas and periampullariy region. During the recent years, mortality rate of~     pancreaticoduodenectomy has decreased to 5% in specialized centers. Although, this procedure~     still carries considerable morbidity up to 40%, depending of definition of complications.~     Pancreatic fistula remains a common complication and the main cause of other morbidities and~     mortality. Pancreaticojejunal (PJ) anastomosis is the most often used method of~     reconstruction after pancreaticoduodenectomy. Several technique modifications such as~     placement of the stents, reinforcement of anasomosis with fibrin glue, pancreatic duct~     occlusion and pancreaticogastrostomy (PG) type of anastomosis was used in order to decrease~     pancreatic fistula rate. Since, some retrospective studies showed better results with some~     technique, several meta-analyses did not show any advantage of those various modifications.~     It was shown that the higher risk of pancreatic fistula was noticed in patients with soft~     residual pancreas and small diameter of pancreatic duct. There is only one randomized study~     in the literature dealing with this problem. This study did not reveal any significant~     differences between PG and PJ in patients with soft pancreas and small duct. In order to~     investigate once more this important issue, the researchers conducted randomized multicenter~     controlled trial.~   "
171171|NCT01324843|"~     Background:~      - Researchers are investigating the use of DNA vaccines to treat various types of cancer by~     provoking an immune system response to tumor cells. DNA vaccines mimic the effect of normal~     vaccines given to prevent infectious diseases, but they have been less effective than~     anticipated in humans. To improve the effectiveness of DNA vaccines, researchers are studying~     alternate delivery methods, such as the investigational Derma Vax(Trademark) injection system~     that delivers the vaccine into the skin. However, because the Derma Vax(Trademark) system has~     not been studied in humans, more research is needed to determine whether this new vaccine~     delivery method is safe and tolerable, particularly in terms of pain levels and skin~     reactions.~      Objectives:~      - To evaluate the safety, effectiveness, and relative pain levels of intradermal~     electroporation using Derma Vax(Trademark) administered after pretreatment with either a~     topical cream anesthetic or placebo cream.~      Eligibility:~      - Healthy individuals between 18 and 55 years of age.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and an electrocardiogram.~        -  Participants will have two different creams applied to their upper arms: one cream will~          be an anesthetic (lidocaine and prilocaine) and the other will be a placebo lotion. Each~          arm will receive a different cream.~        -  Once the cream has taken effect, participants will receive Derma Vax(Trademark)~          treatment. No actual medication will be given during the injection; participants will~          evaluate their reaction based on the pressure and needle stick alone.~        -  Immediately after the treatment, participants will use the Visual Analogue Scale of pain~          intensity to provide a description of the level of pain experienced during the~          injection.~        -  Participants will complete additional questionnaires about pain intensity and will have~          the injected skin site inspected to determine possible reactions to the injection. They~          will also be asked their opinions on whether (based on pain levels) a series of Derma~          Vax(Trademark) treatments would be acceptable for treatment of a serious illness.~        -  The day after the injection, participants will return for an additional skin assessment~          of the treated areas.~   "
171172|NCT01324830|"~     The aim of the Phase Ia (dose escalation) part of this trial is to assess the MTD of BI~     847325 administered at escalating doses in 2 treatment arms. In the Phase Ib expansion part~     of the trial, the aim is to further evaluate the safety profile of BI 847325 at the~     recommended dose and schedule and to assess target modulation and the potential antitumour~     efficacy in patients with selected tumour types.~   "
171173|NCT01324817|"~     The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and~     the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without~     wires and without touching the body.~   "
171174|NCT01324804|"~     The negative effect of internal mammary harvesting on sternal perfusion is well known,~     especially in diabetic subjects. Microdialysis previously showed increased lactate tissue~     concentration after mammary artery preparation. Although high antibiotic concentration is of~     utmost importance in this region, no study previously measured the effect of internal mammary~     artery harvesting on target tissue antibiotic concentration.~      Study hypothesis:~      Internal mammary artery harvesting imposes an additional risk for deep sternal wound~     infection by impairing antibiotic tissue penetration. This effect is mediated by altered~     perfusion patterns and may be seen in cephalosporin and/or Teicoplanin treatment.~      Study objective:~      To evaluate the impact of left internal mammary artery preparation on target tissue~     antibiotic concentration of Cefazolin and Teicoplanin during cardiac surgery~      Design:~      This study is designed as an observational pharmacokinetic trial. Patients are their own~     controls by measuring antibiotic concentration in different subcutaneous tissues.~      Study population:~      Patients referred for coronary artery bypass grafting to the Department of Cardiothoracic~     Surgery with planned unilateral left internal mammary artery preparation and a high risk~     profile for deep sternal wound infections will be asked to participate in this trial.~   "
171175|NCT01324791|"~     Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe~     and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of~     GERD. This prospective randomized study compares objective and subjective outcome parameters~     of Plicator with that of LARS.~   "
171176|NCT01324778|"~     To compare marginal bone level alterations, implant stability and implant survival between~     OsseoSpeed och OsseoSpeed TX~   "
171177|NCT01324765|"~     The goal of the study is to evaluate the efficacy of a two therapeutic models designed to~     enhance women's skills for managing reactive emotions in their current lives as well as to~     educate them about how using these skills can enhance their personal effectiveness and help~     them to gain control of post-traumatic stress reactions. The interventions adaptations of a~     manualized psychotherapy that has shown promise with adults with complex Posttraumatic Stress~     Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET) compared~     to a supportive group therapy (SGT) that has been found to have modest benefits with women~     survivors of childhood abuse (Wallis, 2002).~   "
171178|NCT01324752|"~     The purpose of this study is to determine if Losartan potassium is affected by PA21.~   "
171179|NCT01324739|"~     Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in~     response to myocyte stretching and serves as a reliable biomarker in the diagnosis of cardiac~     dysfunction and heart failure. Recent observations speak for a distinct connection between~     chronic heart failure and diabetes mellitus.~      Objective: The study was set out to investigate the role of BNP on parameters of glucose~     metabolism in a placebo controlled cross-over study in healthy volunteers.~      Methods and Results: Ten participants (25±1 years; BMI 23±1 kg/m2; fasting glucose 83±2~     mg/dL) received either placebo or 3 pmol/kg/min BNP 32 intravenously for 4h. One hour after~     beginning the BNP/placebo infusion, a 3h intravenous glucose tolerance test (0.33 g/kg~     glucose + 0.03 U/kg insulin at 20 min) was performed and plasma glucose, insulin and C~     peptide were frequently measured. BNP increased the initial glucose distribution volume (13±1~     %BW vs. 11±1, P<0.002), leading to an overall reduction of glucose concentration (P<0.001)~     especially during the initial 20 min of the test (P=0.001), accompanied by a reduction of the~     initial C peptide levels (4.3±0.4 ng/mL vs. 4.9±0.3, P=0.015). BNP had no impact on beta cell~     function, insulin clearance or insulin sensitivity.~      Discussion: Intravenous administration of BNP increases glucose initial distribution volume~     and lowers plasma glucose concentrations after a glucose load without affecting beta cell~     function or insulin sensitivity what speaks for the concept that BNP is not diabetogenic, but~     improves the metabolic status in patients with heart failure. This opens new questions~     regarding BNP induced differences in glucose availability and signalling in several~     organs/tissues.~   "
171180|NCT01324726|"~     There has been a great increase in the incidence of infections caused by bacteria that are~     resistant to antibiotic agents. Many of these infections result in worse outcomes of patients~     and increased costs to the healthcare system. The study aims to survey two germs that are~     resistant to a wide range of antibiotics used today. The investigators are particularly~     interested in studying the potential to stop the spread and prevent outbreaks of these germs~     through contact isolation of patients affected by these germs. Patients will be included in~     the study if they have an antibiotic resistant infection caused by any of the 2 bacteria: E.~     coli and K. pneumoniae. The research team will then perform rectal, skin (armpit, groin,~     umbilicus), throat, urine, and, if applicable, wound cultures to determine other sites where~     the germ may be present but not causing an infection. The study coordinator will furthermore~     examine the patient's medical record and conduct a short interview in order to evaluate~     specific information about the bacteria that have been recovered. This research does not~     involve any interventions beyond collection of specimens and there are no added risks to the~     patients from the conduction of the study. Neither will there be a benefit at the patient~     level. The benefit will be at the level of the patient population, i.e. at a larger scale~     once the information collected is analyzed. Only the principal investigator and study~     coordinators will have access to all patient-specific information. Once all information is~     collected, all patient identifiers, such as name and medical record number, will be deleted.~   "
171181|NCT01324713|"~     Bone mineral density (BMD) measurement using dual-energy x-ray absorptiometry (DXA) is the~     current gold standard for osteoporosis diagnosis and therapy monitoring. Like all~     quantitative tests, there is some variability in BMD results obtained when scanning a person~     more than once. As such, it is current clinical practice, based on the recommendation of the~     International Society for Clinical Densitometry, that each technologist perform a precision~     assessment. This approach consists of scanning 30 people twice; the data from which allow~     determination of what constitutes a real difference in BMD with 95% confidence. A precision~     assessment typically evaluates a specific clinic's population, using the age range and~     genders seen at that clinic. However men generally have larger, but often more arthritic,~     bones than women which may impact the precision results. Therefore, it is possible that~     gender-specific precision values should be used in clinical practice, however this issue has~     never been investigated.~   "
171182|NCT01324700|"~     Asthma is common with an increasing prevalence and mortality especially in low-income and~     minority populations. The course of asthma appears to be influenced by mood and emotions. It~     has been reported that there is a high prevalence of depression or depressive symptoms in~     both children and adults with asthma. Despite data on the frequency of depression in asthma~     and its adverse consequences, it is generally not recognized or treated. Brown et al.~     conducted a randomized, double-blind, placebo-controlled trial of citalopram in 90~     outpatients with asthma and MDD. Citalopram therapy was associated with lower depression~     scores, numerically greater rates of remission of depressive symptoms, and less oral~     corticosteroid use than placebo. The investigators proposed study is different. The~     investigators observed a modest difference between antidepressant and placebo in the prior~     trial. However, in a subgroup with more severe asthma (based on frequent corticosteroid use)~     and more severe depression (based on higher depressive symptoms scores) the investigators saw~     a much larger effect size. Standard of care for severe asthma is aggressive asthma treatment.~     The investigators study does not require any changes in the patient's asthma treatment. No~     guidelines are currently available on the treatment of depression in asthma patients.~     Standard care for depression would be antidepressants.~   "
171193|NCT01324557|"~     The aims of this study are to assess the potential efficacy and safety of insulin pump to~     improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for~     diabetic continuous ambulatory peritoneal dialysis (CAPD) patients.~   "
171194|NCT01324544|"~     The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy~     of intravenous (IV) buprenorphine in pediatric patients.~   "
171183|NCT01324687|"~     The system of medical care for older adults with acute illnesses often serves them poorly.~     Many factors limit these patients' access to safe, patient-centered, efficient, high-quality,~     acute care. These factors include a shortage of geriatricians and primary care physicians;~     limited availability of timely, acute-illness, patient appointments; emergency department~     (ED) crowding; interruptions to the continuity of care when patients use the ED; and poor~     transitions of care from the ambulatory setting to the ED. These conditions foster~     unnecessary ED use, adverse events in the ED for which older adults are particularly at-risk,~     and unnecessary medical costs. As the population ages, the magnitude of these problems will~     only increase.~      The overarching study goals are to develop and evaluate a telemedicine-enhanced care model~     that improves access to safe, high-quality, acute illness care for older adults; fosters~     appropriate use of health services; and reduces unnecessary expenditures. Specifically, this~     study aims to:~        1. Expand the existing pediatric HeA telemedicine network to older adults by providing~          senior living communities (SLC) with an alternative on-site care option for individuals~          with an acute illness episode.~           Hypothesis 1: 90% of requested telemedicine visits will be successfully completed.~        2. Evaluate the impact of the HeA telemedicine model on utilization, quality of care, and~          patient safety.~           Hypothesis 2: The rate of ED use will be lower at SLCs with access to care via~          telemedicine, as compared to SLCs without such access to care.~           Hypothesis 3: Quality of care and patient safety measures will be better for SLC~          residents with access to telemedicine-enhanced care than for residents without this form~          of access.~        3. Evaluate the economic benefit of the care delivered through the telemedicine network.~           Hypothesis 4: The net cost of healthcare per patient-month will be less for SLC~          residents with access to telemedicine-enhanced care than for those without this form of~          access.~        4. Use qualitative methods to identify strategies and assets that promote and conditions~          that impede the implementation, acceptance, and success of the HeA telemedicine network~          in SLCs. This knowledge will inform efforts to develop a toolkit to be used to~          disseminate this technology broadly.~   "
171184|NCT01324674|"~     The Common Mental Disorders (CMD) refer to health states involving non-psychotic psychiatric~     symptoms. Part of this broad diagnostic category, symptoms such as difficulty concentrating,~     forgetfulness, insomnia, fatigue, irritability, feelings of worthlessness, somatic~     complaints, etc. The CMD has a big social impact, and its prevalence in the general~     population is 25% and graduate students in health care reaches 40%. The Bach´s Flower~     Remedies are considered a complementary therapy approved and recommended by World Health~     Organization and by the Brazilian Ministry of Health and in his theory it has great spiritual~     nature. In addition, international scientific research have suggested that the strengthening~     of spiritual well-being can help significantly and positively promoting mental health. This~     project aims to assess the relationship between treatment with Bach´s Flower Remedies and~     Spiritual well-being of people with Common Mental Disorders in undergraduate health students~     of a university located in São José dos Campos, state of São Paulo, Brazil. This research~     presents a quantitative and qualitative methodology, experimental clinical trial, triple~     blind. The treatment will take place with two groups of forty people, the group of treatment~     and the placebo´s. The trial will happen in six sessions at intervals of 30 days, totaling~     eight months of treatment. Statistical analysis will be used chi-square or Fisher exact test~     to study the association between the scale of spiritual well-being and the use of Bach~     Flowers for each time point (3 times). To compare the evolution of the results (scales)~     during the study will set a model for ordinal data with repeated measurements over time. For~     these statistical tests is assumed a significance level of 5% (p < 0.005).~   "
171185|NCT01324661|"~     This study examines youth's motivation for food or social rewards after a brief episode of~     simulated ostracism. The investigators hypothesize that youth who think about a friend after~     being ostracized will mediate their decision to resort to food, which is typically evidenced~     in socially isolated overweight youth.~   "
171186|NCT01324648|"~     Lifetime prevalence rates of Major Depressive Disorder (MDD) in Canada are between 10-12%~     with approximately 1.5 million Canadians reporting depression in any given year. Alarmingly,~     the burden of ill health associated with MDD is projected to increase worldwide such that by~     the year 2020, depression will move from its current position of fourth to become the second~     greatest burden of ill health, closely following ischaemic heart disease (Murray & Lopez,~     1998). As depressed patients are often in frequent contact with their primary care physicians~     for other health problems, effective depression treatment and management currently relies~     heavily on the primary care sector. Cognitive behavioural therapy (CBT) is an empirically~     supported psychotherapy that is recommended by the Canadian Network for Mood and Anxiety~     Treatments Clinical Guidelines as a first-line treatment for depression. However, across~     Canada, CBT is not readily accessible by primary care physicians for their patients,~     particularly in rural areas.~      To help address this nationwide need for CBT, British Columbia (BC) is the first and only~     province in Canada to develop and implement a high capacity mental health service, Bounce~     Back: Reclaim your Health (BB), for primary care patients with mild to moderate depression.~     In BB, the patients' use of Cognitive-Behavioural Therapy (CBT) self-help materials is~     supported via trained telephone coaches.~      The primary objective of our proposed research is to provide direct evidence of the~     effectiveness of the BB program, and, in particular, the telephone coaching component. The~     investigators will test: (1) whether the BB program is more effective than general~     practitioner (GP) treatment-as-usual (TAU); and (2) whether BB's positive results can be~     attributed to the telephone coaching component, as this component is associated with the most~     significant costs of the program. A secondary objective is to assess the cost-effectiveness~     of such telephone support.~   "
171187|NCT01324635|"~     This is an open label phase I clinical trial with two arms, representing single and~     fractionated radiation therapy (Figure 4.1). Within each arm the radiation dose is~     pre-determined and not escalated. Panobinostat will be administered orally 3 times a week for~     2 weeks. Panobinostat will be dose-escalated independently in each arm. There is no~     intra-patient dose escalation.~      Recurrent gliomas (Arm A) will be treated according to the Jefferson protocol for~     re-irradiation, 10 fractions each of 3.5Gy delivered over 2 weeks. Panobinostat will be~     administered orally three times a week for 2 weeks, starting on day 1 or 2 of radiation~     therapy. High-grade meningiomas (Arm A) will be treated with 6 weeks/30 fractions of~     fractionated radiation therapy, to a total dose of between 54 Gy and 60 Gy in fractions of~     either 1.8Gy or 2Gy. Panobinostat will be administered orally three times a week for 2 weeks,~     starting on the day of 1st fraction of radiation.~      Large brain metastases (Arm B) will be treated with a single fraction of radiosurgery.~     Panobinostat will be administered orally three times a week for 2 weeks, starting on the day~     of radiation. The radiosurgery may be delivered by either LINAC, gamma-knife, cyber-knife or~     tomotherapy technology.~   "
171188|NCT01324622|"~     The objective of this study is to compare the clinical and radiographic outcomes of~     multi-level laminectomy to multi-level laminoplasty in the treatment of patients with~     cervical myelopathy or myeloradiculopathy. The hypothesis for the study is that the~     laminoplasty group is not inferior to the laminectomy group.~   "
171189|NCT01324609|"~     The purpose of this study is to determine if the investigators can detect the presence of~     choroidal nevi cells in the vitreous fluid of humans, as this may improve the diagnosis and~     classification of choroidal nevi and melanomas in the future.~   "
171190|NCT01324596|"~     The aims of this study are:~        -  To evaluate the benefits of the addition of bortezomib to standard rituximab with~          cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP) therapy in Diffuse~          Large B-cell Lymphoma (DLBCL).~        -  To determine whether molecular phenotype effects the benefits derived from the addition~          of bortezomib.~   "
171195|NCT01324531|"~     The purpose of this prospective, randomized, controlled trial is to compare subjective~     patient-reported outcomes and objective clinical results between arthroscopic Bankart repair~     with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder~     instability with a Hill-Sachs Defect.~   "
171196|NCT01324518|"~     The purpose of this study is to determine whether ORM-12741 is safe and effective in the~     treatment of Alzheimer's disease.~   "
171197|NCT01324505|"~     This clinical trial is conducted in Europe. The purpose of the trial is to investigate the~     influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the~     body) of an oral contraceptive combination drug after multiple administration of semaglutide~     in female subjects with type 2 diabetes.~   "
171198|NCT01324492|"~     The present study is designed to collect safety/tolerability data and explore the efficacy of~     RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.~   "
171199|NCT01324479|"~     This study will assess the safety and efficacy of INC280 in patients with solid tumors that~     are refractory to current treatment or for which there is not a current standard of care and~     whose tumors have dysregulation of the c-MET pathway.~   "
171200|NCT01324466|"~     The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects~     with recurrent herpes labialis (RHL).~   "
171201|NCT01324453|"~     This study will evaluate change in heart muscle function from baseline to three months and~     twelve months in participants who present with a heart attack and a completely occluded~     coronary artery. These subjects will be randomized to receive standard Percutaneous~     transluminal coronary angioplasty (PTCA)/Stenting to open the artery or routine PTCA/Stenting~     plus post conditioning. Post conditioning commences immediately upon reperfusion using four~     cycles of thirty second inflations with a standard angioplasty balloon followed by a thirty~     seconds of reperfusion. The investigators hypothesize that Postconditioning reduces the size~     of the heart attack when utilized with successful primary Angioplasty/stent.~   "
171202|NCT01324440|"~     The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the~     Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).~   "
171203|NCT01324427|"~     Telemedicine is a new area of health care where medical information is transferred through~     audiovisual media, such as a computer or a video camera, for the purpose of remote doctor's~     visits or examinations. This new area of health care is important to test because it can~     potentially provide real-time interactions between the patient and their health care team,~     including phone conversations, online communication, and/or home visits. Many activities such~     as a history review or physical examination can be conducted virtually as compared to the~     traditional face-to face visits.~      The purpose of this study is to determine patient and health care team acceptance of a~     virtual medical visit as a substitute for a face to face visit for patients either~     preparing to receive a stem cell transplant or previously received a stem cell transplant.~   "
171204|NCT01324414|"~     The incidence of Non alcoholic fatty liver disease (NAFLD) continues to increase, and~     prevalence estimates for NAFLD range from 17-33%, making it is the most common cause of~     chronic liver disease in North America. It is associated with increased cardiovascular~     morbidity as well as progression to cirrhosis is a subset of patients. There is currently no~     approved treatment for NAFLD. A key barrier to the development of effective therapies is a~     lack of consensus on the criteria for diagnosis and endpoints for studies evaluating~     diagnostic markers, prognosis and therapeutic modalities.~      NAFLD encompasses an entire pathological spectrum of disease, from relatively benign~     accumulation of lipid (steatosis) to progressive non alcoholic steatohepatitis (NASH)~     associated with inflammation, fibrosis, and necrosis. It has been estimated that 20-30% of~     patients with NAFLD will exhibit biochemical and histological changes characteristic of NASH,~     and 15-20% of those patients will progress to have cirrhosis. NASH remains an important~     phenotypic state, because this sub-group of patients is deemed at high-risk for developing~     progressive disease resulting in cirrhosis, liver failure requiring transplantation, or~     death.~      Although NAFLD has not to date been included as a component of the metabolic syndrome, there~     is increasing evidence that NAFLD frequently accompanies the development of insulin~     resistance and therefore may be an indicator or predictor of future cardiometabolic risk.~     Moreover, recent findings in skeletal muscle of experimental insulin resistance (lipid~     infusion) as well as naturally occurring obese and type 2 diabetic, insulin resistant~     patients show that skeletal muscle inflammation leads to a pattern of extracellular matrix,~     structural, and remodeling abnormalities that closely resemble the TGFb, connective tissue~     growth factor (CTGF) mediated fibrotic response that differentiates simple steatotic liver~     from NASH. This suggests there may be a common underlying mechanism. Given the ready~     availability of skeletal muscle tissue using percutaneous needle muscle biopsies, compared to~     the more invasive liver biopsy, it may be possible to use characteristics of skeletal muscle~     to distinguish the severity of liver fibrosis.~      Given the preponderance of patients being identified with NAFLD, the recognition of less and~     non invasive tests that help to discriminate the different phenotypic types of NAFLD would be~     highly practical and useful. This would help identify patients at risk of progression to~     cirrhosis, and thus make them the target of any available therapeutic interventions.~      The investigators hypothesize that 1. Insulin resistance measured through glucose tolerance~     test directly correlates with the extent of liver and muscle fibrosis, and 2. Inflammation~     and fibrosis in the skeletal muscles correlates with the histopathological changes seen in~     patients with NAFLD, and potentially skeletal muscle inflammation may be used as a diagnostic~     predictor to differentiate patients with NASH from patients with simple steatosis.~      The overall goal of this project is to determine the extent to which inflammation and~     fibrosis in skeletal muscle mirrors and is predictive of the level of liver inflammation and~     can distinguish NASH from simple steatosis. Specifically, the investigators propose the~     following Aims:~        1. To use estimates of insulin sensitivity from modeling of oral glucose tolerance tests to~          test the hypothesis that the extent of liver and muscle fibrosis is directly related to~          insulin resistance.~        2. To use liver and muscle biopsies to characterize the changes in abundance of mRNAs and~          proteins that characterize inflammation, extracellular matrix remodeling, and fibrosis.~          The investigators will use quantitative rt-PCR and immunoblot analysis to compare mRNA~          expression and protein abundance of collagens I and III, fibronectin, and connective~          tissue growth factor (CTGF) to test the hypothesis that there is a direct relationship~          between the levels of these proteins in muscle and liver and the degree of fibrosis.~        3. To establish a biospecimen repository of serum, mRNA from circulating white blood cells,~          liver and muscle tissue, and DNA to serve as the substrate for future studies of the~          pathogenesis of NASH.~   "
171205|NCT01324401|"~     Peanut allergy is one of the most serious food allergies because of its life long~     persistence, and the potential for severe allergic reactions. Effective oral immunotherapy~     would benefit patients by reducing the likelihood that they will have life-threatening~     accidental allergic reactions. This research study is being done to develop an effective oral~     immunotherapy treatment for patients with peanut allergy.~   "
171206|NCT01324388|"~     The purpose of this study is twofold:~        1. To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering~          drug (lisinopril) in participants with high blood pressure who are currently taking~          lisinopril.~        2. To evaluate the effect of LY2189265 on heart rate and blood pressure in healthy~          volunteers when taken with a Beta-blocker drug (metoprolol).~      In Part 1, participants will receive four weekly injections of LY2189265 with continued use~     of normal lisinopril therapy.~      Part 2 is a cross-over study design. Participants will receive a single injection of~     LY2189265 in one period, and seven daily doses of metoprolol and a single injection of~     LY2189265 in another period.~   "
171207|NCT01324375|"~     In this consecutive, prospective cohort study the investigators evaluate if preoperative pain~     response upon heat stimulation is predictive for acute and subacute postoperative pain after~     total hip arthroplasty.~   "
171208|NCT01324362|"~     The purpose of this study was to determine whether asthma control and reduced bronchial~     responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids~     with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma~   "
171209|NCT01324349|"~     The objective of this study is to evaluate the safety and effectiveness of Covidien's~     Hemostatic Patch to control bleeding during hepatic surgery. The performance of the~     Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic~     techniques.~   "
171210|NCT01324336|"~     The purpose of this study is to compare the pharmacokinetics of a routinely used compounded~     liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients~     who are receiving treatment with 6-MP as part of their clinical treatment for acute~     lymphoblastic leukemia (ALL).~   "
171211|NCT01324323|"~     The purpose of this study is to evaluate the effect and safety of multiple doses of rifampin~     on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.~   "
171212|NCT01324310|"~     The purpose of this study is to evaluate the effect and safety of multiple doses of~     ketoconazole on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.~   "
171213|NCT01324297|"~     The purpose of this study is to gather normative data from healthy adults and to determine a~     sensitive and specific cut-off value for responders and non-responders to the Niacin Skin~     Flush Test in a sample of first episode psychosis patients.~   "
171214|NCT01324284|"~     Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel~     preparation can be improved for a good colonoscopic examination without missing lesions and~     complications.~   "
171215|NCT01324271|"~     The objective of the study is to evaluate the safety and efficacy of the Acclarent~     Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under~     local anesthesia in an office/clinic setting.~   "
171216|NCT01324258|"~     This is the first clinical experience in Japan with GSK1120212, a novel MEK inhibitor. This~     study is designed to identify recommended doses and regimens in Japanese subjects for the~     future development of GSK1120212.~   "
171217|NCT01324245|"~     The kidney plays a crucial role in maintaining salt balance by two opposing physiological~     mechanisms: the renal dopaminergic system which enhances salt excretion and the~     renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension~     occurs when this balance is altered or abnormal. We hypothesized that this balance is~     influenced by salt intake: therefore dietary salt affects the natriuretic response to the~     renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor,~     Enalapril.~      In this trial we study normal salt balance mechanisms in salt resistant adults with normal~     blood pressure.~   "
171218|NCT01324232|"~     The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses~     of AVP-923 capsules in the treatment of central neuropathic pain in patients with multiple~     sclerosis.~   "
171219|NCT01324219|"~     The investigators are interested in reducing problem behaviors of nursing home residents with~     dementia that make providing care difficult. The investigators call these behaviors~     resistiveness to care. Previous research has found that resistiveness to care occurs more~     frequently when staff use certain types of communication. An inservice program will be~     provided to all nursing staff in your nursing home to teach staff about communication~     practices to reduce resistiveness to care. The research study will see whether changing~     communication will reduce resident resistiveness to care. If effective, the communication~     training may then be used to improve care in other facilities.~      By doing this study, researchers hope to learn if changing communication practices will~     reduce resistiveness to care in nursing home residents with dementia.~   "
171220|NCT01324206|"~     Background:~      - Magnetic resonance imaging (MRI) studies provide important information on the structure and~     function of various body systems, including the brain, muscles, joints, heart, and blood~     vessels. Scientific applications of MRI scans often use techniques that need to be modified~     or refined before they are used in clinical studies. To develop and modify these techniques~     for the new Philips 3T Achieva whole-body MRI scanner, researchers are interested in~     conducting trial MRI scans on healthy individuals and individuals with conditions that~     require imaging studies.~      Objectives:~      - To conduct preliminary trials of the 3T MRI facility to develop and refine MRI scanning~     procedures.~      Eligibility:~      - Individuals at least 18 years of age who are able to have magnetic resonance imaging.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests.~        -  Participants will have an MRI scan using the 3T scanner. Some scans may require the use~          of a contrast agent or radiotracer, which is a small amount of radioactive substance~          that will be injected before the start of the scan. Some participants may be asked to~          perform tasks of thinking and movement while in the scanner, in order to test the~          procedures required for a functional MRI scan.~        -  No treatment will be provided as part of this protocol.~   "
171221|NCT01324193|"~     Chronic kidney disease (CKD) patients have very low physical function and high rates of~     cardiovascular disease (CVD) mortality. The objective of the proposed research is to evaluate~     the effects of dietary supplementation with a pomegranate extract, that contains high amounts~     of antioxidants, on physical function and CVD risk. Patients with moderate to severe chronic~     kidney disease that are NOT yet on dialysis tend to have significantly reduced risk factors~     for cardiovascular disease (and other disorders) compared to dialysis patients. This includes~     significantly reduced systemic markers of oxidative stress and inflammation. As a result,~     therapies designed to reduce the risk of CKD co-morbidities may differ significantly in~     dialysis and pre-dialysis patients. For example, dialysis patients are recommended to~     INCREASE their intake of dietary protein, while pre-dialysis patients are recommended to~     DECREASE their protein intake, due to differences in the pathophysiology of the two~     conditions. The investigators have decided to recruit pre-dialysis patients in addition to~     dialysis patients in this study because the investigators believe this will help us determine~     if the efficacy of pomegranate differs between patients with different stages of CKD.~   "
171222|NCT01324180|"~     H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator,~     but will not be recruiting locally.~      The purpose of the trial is to study the clinical and biological effects of metformin in~     combination with standard systemic chemotherapy in a disease (relapsed ALL) that has a dismal~     outcome, as well as to do a dose escalation study to find the Maximum Tolerated Dose (MTD) of~     metformin in conjunction with ALL therapy. There have also been analysis of patients enrolled~     on trials who were diabetics on metformin and their outcome was better than patients on the~     same trial that were not on metformin as their antihyperglycemic.~   "
171223|NCT01324167|"~     The investigators would like to know the association of gene polymorphisms and metabolic~     adversities in clozapine-treated patients with schizophrenia in Taiwan.~   "
171224|NCT01324141|"~     Background:~      - Radiation and chemotherapy treatments for anal cancer can cause irritation of the skin that~     can lead to redness and tenderness, and in some cases can be so severe that it results in~     blistering or peeling of the skin during treatment. These conditions cause discomfort and may~     require breaks from radiation treatment. Researchers are interested in determining whether~     MTS-01, a drug that protects cells and tissues from the effects of radiation, can be given~     before radiation treatment to prevent these side effects and reduce the irritation of the~     skin during chemotherapy and radiation for anal cancer.~      Objectives:~      - To determine the safety and effectiveness of topical MTS-01 given before radiation in the~     groin and gluteal cleft of patients receiving combined radiation and chemotherapy for anal~     cancer.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with cancer of the anal canal~     and are eligible to receive radiation and chemotherapy treatments.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          imaging studies and physical examination of the anal canal, and biopsies as needed to~          evaluate eligibility for treatment.~        -  Participants will be scheduled for radiation and chemotherapy treatments on the~          following schedule:~        -  Radiation given 5 days per week for 6 weeks, with topical MTS-01 treatment on the skin~          in the groin areas and between the buttocks before each treatment~        -  Mitomycin C given intravenously on days 1 and 29 of treatment~        -  5-Fluorouracil given intravenously over 4 days (first week and fifth week) during~          radiation treatment~        -  Participants will be monitored throughout the treatment for side effects, with~          photographs of the treatment area and frequent blood tests.~        -  Following the end of radiation, participants will have followup visits for 1 year with~          blood tests and imaging studies to evaluate the response to treatment.~   "
171225|NCT01324128|"~     This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety~     and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis~     patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate~     levels in these patients.~   "
171226|NCT01324115|"~     RATIONALE: NG-nitro-L-arginine may stop the growth of tumor cells by disrupting blood flow to~     the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of NG-nitro-L-arginine~     in treating patients with advanced solid tumors.~   "
171227|NCT01324102|"~     With advances in the detection and treatment of cancer, there are now 14 million cancer~     survivors in the U.S., 500,000 of whom are treated in the Veterans Health Administration. The~     mental and physical health consequences of cancer and its treatment may affect a Veteran's~     functioning and re-integration back into family, work, and daily life. Recent studies suggest~     that yoga may be an effective intervention for improving both the physical and mental health~     of individuals after cancer, although this has not been studied in Veterans. This study has~     three components: (1) Determine factors that increase participation in Yoga by Veterans using~     individual interviews and focus group; (2) Create a Yoga protocol for Veterans adapted from~     an existing empirically supported treatment, akin to a phase 1 clinical trial for safety and~     tolerability; (3) Evaluate the efficacy of Yoga for improving fatigue, insomnia, anxiety, and~     depression after treatment for colorectal cancer, akin to a phase 2 trial with randomization.~   "
171228|NCT01324089|"~     There is some evidence that when resveratrol (a substance which is found in red grapes,~     peanuts and chocolate) is combined with Piperine (a substance found in pepper) it is more~     effective in fighting cancer. The purpose of this study is to see if resveratrol in~     combination with piperine is more effective than taking resveratrol alone. Since~     investigators don't know what dose of piperine to use in combination with resveratrol, two~     different doses of piperine will be studied.~      Twenty-four participants, equal numbers of males and females, will receive a single dose of~     resveratrol (2.5 grams) without piperine, resveratrol (2.5 grams) with piperine (5 mg), or~     resveratrol (2.5 grams) with piperine (25 mg).~   "
171229|NCT01324076|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking~     the blood flow to the tumor. Sorafenib tosylate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~     It is not yet known whether transarterial chemoembolization using doxorubicin-eluting beads~     is more effective when given with or without sorafenib tosylate in treating patients with~     liver cancer that cannot be removed by surgery.~      PURPOSE: This randomized phase III trial is studying giving transarterial chemoembolization~     using doxorubicin-eluting beads and sorafenib tosylate to see how well it works compared with~     giving transarterial chemoembolization using doxorubicin-eluting beads and a placebo in~     treating patients with liver cancer that cannot be removed by surgery.~   "
171230|NCT01324063|"~     RATIONALE: Patient abstract not available~      PURPOSE: Patient abstract not available~   "
171231|NCT01324050|"~     The overall aim of this study is to develop and test a psychodynamic Internet-delivered~     psychological treatment for patients with mild to moderate major depression and compare its~     efficacy to an active control group.~   "
171232|NCT01324037|"~     Deep vein thrombosis (DVT) of the arm, officially called upper extremity DVT is a rare~     disorder and accounts for up to 1-4% of all cases of deep vein thrombosis. In case of a~     thrombosis, there is a blood clot in one of the veins, which should be treated with blood~     thinners (anticoagulants). The aim of the present study is to see whether it is safe to use a~     combination of tests for the diagnosis of arm thrombosis. In all patients, we will use a~     clinical decision rule (clinical judgement) and a laboratory test (D-dimer testing), in most~     patients also an ultrasound of the arm will be done. The combination of these tests was found~     to be safe and effective in patients with thrombosis of the legs.~   "
171233|NCT01324024|"~     The purpose of this study is to determine whether a medication called Vyvanse®~     (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of~     sustained attention, verbal encoding and recall and working memory, in menopausal aged women.~     LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The~     cognitive difficulties that menopausal women report experiencing are typical of adults who~     are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in~     alleviating those cognitive disruptions when compared to a placebo.~   "
171234|NCT01324011|"~     NOTE: This study is in the trial-phase of a 5-year study that included a formative research~     phase (Phase 1 - IRB study # 07-1765 Family-based Diabetes Self-management Training for~     African American Adults). During the first phase, eight focus groups were conducted with 68~     participants and a validation study with 215 African American patients with type 2 diabetes.~     The data gathered in Phase 1 informs the refinement of the intervention in this phase.~      Purpose: The overall goal of this research is to evaluate, in a randomized controlled trial,~     a family-based diabetes self-management intervention for overweight/obese African American~     adults with type 2 diabetes (the index participants) and a paired overweight family member~     (co-participant) who does not have diabetes. The primary outcome is weight change in the~     index participant.~   "
171235|NCT01323998|"~     This retrospective study aims to assess treatment patterns within 1 year of initiating BPH~     treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB)~     monotherapy, early combination therapy, and delayed combination therapy. The MarketScan~     database will be utilized for this study (2000-2008)~   "
171236|NCT01323985|"~     The purpose of this study is to provide safety information and to define the optimal~     induction and short term maintenance regimen for GSK2315698 to deplete circulating SAP in~     healthy volunteers prior to assessing in patients~   "
171237|NCT01323972|"~     The purpose of this study is to show the consistency of different lots of a candidate vaccine~     (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.~   "
171238|NCT01323959|"~     This study will evaluate the persistence of immune response against diphtheria, tetanus,~     pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess~     the immunogenicity and safety of another booster dose of BoostrixTM Polio.~   "
171239|NCT01323946|"~     The objective of the study is to evaluate the immunogenicity and safety of prime-boost~     vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.~   "
171240|NCT01323933|"~     Analysis of safety, tolerability, and PK data will provide information that will guide future~     development of AB0024.~   "
171361|NCT01322347|"~     The purpose of this study is to confirm the safety and efficacy of Soluble Ferric~     Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in~     anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will~     be measured primarily by the change from baseline in hemoglobin (Hgb).~   "
171241|NCT01323920|"~     A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a~     complication of transplantation where the donor graft attacks and damages some of your~     tissues. After stem cell transplant, all patients receive prophylactic medications against~     GVHD.~      In this research study, we are studying the safety and effectiveness of a bortezomib based~     GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call~     transplantation from a matched unrelated donor, mismatched related or unrelated donor.~   "
171242|NCT01323907|"~     The purpose of the study is to provide use of Omegaven in children with life threatening~     Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical~     treatments/therapies have been either ineffective or not feasible in the treatment of this~     serious condition. This is a compassionate use protocol.~   "
171243|NCT01323894|"~     The first year purpose:~      The best concentration of canonical Wnt3a will be investigated in promoting the~     osteoblastogenesis of human mesenchymal stem cells.~   "
171244|NCT01323881|"~     This pilot sham-controlled study aims to determine the safety and efficacy of repetitive~     transcranial magnetic stimulation given as a facilitatory intermittent theta burst~     stimulation (iTBS1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute~     stroke patients.~   "
171245|NCT01323868|"~     The purpose of this study is to determine the rate of endogenous endophthalmitis in patients~     admitted to Stanford Hospital with a systemic infection and positive blood cultures, as this~     may improve the clinical care of this population of patients.~   "
171246|NCT01323855|"~     This is a two part study to compare the PK of preladenant administered to participants with~     CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK~     of participants with severe CRI to healthy participants. Part 2 will compare the PK of~     participants with moderate CRI and participants with mild CRI to healthy participants. The~     primary hypotheses are that the plasma area under the concentration-time curve from time 0 to~     infinity after single dosing (AUC0-∞) of preladenant in participants with either severe,~     moderate or mild CRI is similar to that of matched healthy participants.~   "
171247|NCT01323842|"~     Renal colic is a common (1300 visits per year at our institution) and painful condition~     caused by stones in the kidney and ureter, and can be mimicked by life threatening conditions~     such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical uncertainty.~     Emergency department targeted ultrasound (EDTU) is performed by an emergency physician at the~     patient's bedside, and has been shown to be accurate, safe, and efficient. We have shown that~     EDTU can accurately identify hydronephrosis, which is a predictor of complications of kidney~     stones. A normal formal ultrasound (US) predicts an uncomplicated clinical course. We will~     assess the accuracy of EDTU for the diagnosis of hydronephrosis, and when normal, whether~     patients can be safely discharged.~   "
171248|NCT01323829|"~     This is a prospective, pilot, longitudinal study to evaluate the use of EMG guidance for~     Botox A injection for chronic pelvic pain and HTPFD. The objective of this study is to~     determine the efficacy of injecting botulinum toxin type A into pelvic floor muscles that are~     high tone. Patients who have been diagnosed with high tone pelvic floor muscle dysfunction~     and have failed other treatments will be eligible to participate in this study. Study related~     procedures will include perineometry readings. Patients will be required to complete 7~     questionnaires for this study. These include visual analog scale (scale from 0-10) for pain~     (VAS), the O'Leary-Sant urinary symptoms and problem questionnaires (ICSI/ICPI), Pelvic Floor~     Distress Inventory 20 (PFDI-20), the Female Sexual Distress Scale (FSDS), Global Response~     Assessment Scale and the SF-12 quality of life scale. The use of the EMG guidance is the~     experimental part of the study. We will perform EMG Needle testing in order to pin-point the~     best location for the patients Botox injections. This is a prospective, pilot, longitudinal~     study to evaluate the effect of Botox A injection for chronic pelvic pain and HTPFD.~   "
171249|NCT01323816|"~     The purpose of this study is to evaluate and compare outcomes of patients that have received~     care in medical intensive care units in a tertiary care facility with two different models;~     the traditional model including resident, pulmonary fellow and attending physician and a~     nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary~     fellow, and an attending.~   "
171250|NCT01323803|"~     This study will establish a registry for participants with eosinophilic esophagitis (EoE) and~     create a research resource that will provide further insights into EoE.~   "
171251|NCT01323790|"~     The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of~     opioid-induced constipation in patients with non-cancer-related pain, including those~     patients that have inadequate response to laxative therapy (LIR).~   "
171252|NCT01323777|"~     The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +3.0~     D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace~     the natural lens in Japanese cataract patients.~   "
171253|NCT01323764|"~     The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus~     Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function~     in patients with adult hydrocephalus (AH) implanted with ventriculoperitoneal (VP) shunts~     when shunt obstruction is suspected and a diagnostic procedure such as radionuclide shunt~     patency testing (SPS) is required.~   "
171254|NCT01323751|"~     Phase 1(a & b): To evaluate the side effects and determine the best dose of oral ACY-1215 as~     monotherapy, and also in combination with bortezomib and dexamethasone in patients with~     relapsed or relapsed/refractory multiple myeloma.~      Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with~     bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple~     myeloma.~   "
171282|NCT01323387|"~     Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative~     disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.~      The primary objective of this study to measure fusion success in patients with lumbar~     degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is~     evaluation of the patient's quality of life, pain and function.~   "
172002|NCT01313910|"~     The purpose of the study is to see if ImmunoLin® will reduce the frequency of bowel movements~     and gastrointestinal (GI) symptoms in HIV volunteers with persistent GI symptoms. The study~     will also examine the effect of ImmunoLin® on the bacteria in the gut and the immune system~     in gut tissue as well as in the blood.~   "
171255|NCT01323738|"~     Many people suffering from alcohol dependence have a history of exposure to stressful life~     situations, such as childhood physical or emotional misuse. Often, there's a functional~     relationship between drinking and emotional problems related to past traumatic experiences,~     i.e. drinking to forget. However, alcohol treatment often does not include interventions to~     support patients to cope better with past life experiences. On the other hand, most~     alcoholics are poorly motivated to participate in long-term rehabilitative treatments after~     detoxification. In the proposed study, the investigators will study the effects of a brief~     psycho-educational group intervention during detoxification treatment on motivation to change~     and the willingness to accept further treatment.~      The investigators will use a group comparison design (intervention versus TAS control~     group). In month 1, patients take part in Treatment as Usual (TAS), including a unspecific~     information group. In month 2, the information group is replaced by the psychoeducational~     group (intervention). Ward staff selects patients for the groups, irrespective of~     intervention or TAS. Selection criteria are: absence of severe withdrawal and cognitive~     impairment. Absence of severe co-morbid psychiatric disorder (e.g. schizophrenia or suicidal~     crisis). The group sessions will take place in groups of up to 15 patients and will include 4~     structured sessions (45 min each). Main content if the intervention group is to highlight and~     discuss the association between stress, Posttraumatic Stress Disorder and drinking. Patients~     will also be informed about the different treatment options available in the region.~      At entry, patients are asked to fill in the German versions of the University of Rhode Island~     Change Assessment (URICA; McConnaughy, Prochaska, & Velicer, 1983; German: Heidenreich, Hoyer~     & Fecht; 2001) and the Trauma History Questionnaire (THQ; Green, 1996; German: Maercker,~     2002). At discharge, patients are asked to fill in the URICA.~      The investigators expect that specific information on the association between stress and~     drinking will increase the patients' motivation to participate in further treatment.~   "
171256|NCT01323725|"~     The purpose of this study is to identify the effectiveness of team-base financial incentives~     for increasing long-term smoking cessation among employees at St. Paul's Hospital, Korea.~   "
171257|NCT01323712|"~     Patients with Chronic Kidney Disease (CKD) are upto 3.5 times more likely to die from~     diseases of heart and blood vessels (Cardiovascular Disease-CVD). Vitamin D insufficiency is~     very common in CKD and associated with CVD. Animal studies have shown an improvement in heart~     size and function with Vitamin D therapy, although evidence in humans is lacking. The~     proposed study will test if oral Vitamin D treatment, in deficient CKD patients, will improve~     heart enlargement and function. With these proposed changes the investigators expect to~     reduce CVD and deaths in patients with CKD.~   "
171258|NCT01323699|"~     Behavioral Treatments for Anxiety and Depression (BehTA-D) is a research study for anxiety~     and depression in individuals with Parkinson's disease (PD). The research clinicians try to~     teach skills that may help participants cope with anxiety and depression in the context of~     Parkinson's disease. Research clinicians will also discuss ways improve management of~     Parkinson's symptoms. Other skills taught include how to relax, change thinking, add in~     meaningful pleasant activity.~   "
171259|NCT01323686|"~     The aim of this study is to investigate if imaging guided optimal left ventricular (LV) lead~     placement improves the response rate to cardiac resynchronization therapy (CRT). Consecutive~     patients meeting the standard criteria for CRT are included in a prospective, double-blinded,~     randomized trial to LV lead positioning either 1) guided by cardiac imaging using~     echocardiography, single-photon emission computed tomography, and visualization of cardiac~     venous anatomy (cardiac computed tomography (CT), venography) to target an epicardial vein at~     the site of latest mechanical activation without scar tissue or 2) using standard LV lead~     placement.~   "
171260|NCT01323673|"~     The purpose of this study is to determine how clobetasol proprionate foam works against a~     placebo foam in the treatment of hand dermatitis.~   "
171261|NCT01323660|"~     This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination~     and component, two-period, incomplete block design cross-over study using GSK573719/GW642444.~     The primary objective is to evaluate lung function and exercise endurance time after 12 weeks~     of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and~     62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25~     mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI).~   "
171262|NCT01323647|"~     This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18~     months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in~     the primary study. The study will also assess the immunogenicity and reactogenicity of a~     booster dose of IPV in subjects primed with three doses of IPV.~   "
171263|NCT01323634|"~     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI~     100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily~     over a 12-week treatment period in subjects with COPD.~   "
171264|NCT01323621|"~     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI~     100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily~     over a 12-week treatment period in subjects with COPD.~   "
171265|NCT01323608|"~     The purpose of this pilot study is to determine the effect of various doses of vitamin D~     supplementation on vitamin D stores and calcium excretion in the urine in subjects with~     Thalassemia Major (TM). Subjects with TM are routinely placed on vitamin D supplements~     because they frequently have osteoporosis (a condition in which bone tissue thins and loses~     density and strength) and low vitamin D stores. The amount of vitamin D supplementation that~     is required to raise vitamin D stores in optimal levels is not known in TM, and will be~     determined in this study. Finally, a recent study in TM has linked blood vitamin D levels to~     urine calcium excretion, which is a risk factor for kidney stones. Therefore, we want to~     determine changes in calcium excretion with various vitamin D doses and with increasing~     vitamin D stores. We plan to test 3 doses of vitamin D for 3 months in children and adults~     with TM. Changes in vitamin D blood levels and urinary calcium will be determined. The~     results of this pilot study will be used in future studies that will examine the effect of~     various doses of vitamin D supplementation in the treatment of osteoporosis in TM.~   "
171280|NCT01323413|"~     The purpose of the study is to examine the influence of demographic, clinical and laboratory~     characteristics on the presence and size of penumbra in acute ischemic stroke patients and to~     determine those of them which related significantly and independently to the presence and~     size of Penumbra. The examined factors will include demographic variables such as age,~     gender, ethnic background, vascular risk factors and medical history, clinical parameters~     such as time from stroke onset until arrival to the hospital, results of neurological~     evaluation by NIHSS and imaging findings, laboratory tests such as body temperature, blood~     pressure, glucose level, renal functions etc. and imaging findings - the presence and the~     size of collateral blood vessels, the state of carotid arteries (by CTA). The possible~     correlation between all this parameters and the presence and the size of penumbra as detected~     by CTP will be further examined.~   "
171266|NCT01323595|"~     While narcotic medication are commonly used for pain control near the time of surgery, there~     are significant side effects including constipation, nausea, risk of overdose leading to~     decreased breathing, and risk of addiction to narcotics. Our goal is to explore alternatives~     to narcotics for perioperative pain for patients undergoing sperm retrieval surgery. We have~     designed a prospective randomized clinical trial to evaluate how effective the~     anti-inflammatory medicine celecoxib(Celebrex©) is for pain control near the time of surgery.~     Celecoxib is known as a COX-2 inhibitor, a drug that belongs to the non-steroidal~     anti-inflammatory drug (NSAID) class. It is used to reduce swelling and to treat pain.~      Patients will be divided into two groups: the first group receives a celecoxib pill and the~     second group receives a sugar pill(placebo). Patients and doctors will be unaware of exactly~     which pills are given. The patient will complete questionnaires for pain level. By comparing~     the pain levels we can better understand whether celecoxib (Celebrex©) significantly~     decreases perioperative pain.~   "
171267|NCT01323582|"~     Erythromycin is effectively used in the treatment of Gastroparesis (GP) patients. In~     susceptible patients however, it has been associated with sudden cardiac death due to~     prolongation of QT intervals and subsequent cardiac risks through its interaction some other~     drugs. Azithromycin (AZI) is a macrolide antibiotic but does not have the mentioned druf~     interactions , has fewer gastrointestinal side effects, and fewer risks of QT prolongation~     and cardiac arrhythmias. Consequently, AZI avoids drawbacks of dosing with erythromycin and~     may be preferred as a prokinetic agent in patients on other concomitant medications.~      We hope to demonstrate the effectiveness of Azithromycin (AZI) as compared to Erythromycin in~     the treatment of Gastroparesis (GP), and later, form the framework for larger~     randomized-controlled parallel studies to investigate use of AZI for treatment of GP.~      Our novel hypothesis is to determine whether AZI can be used to treat GP.~   "
171268|NCT01323569|"~     This crossover study with six treatment sessions is to evaluate the abuse potential of three~     doses of Sativex as compared to Marinol and placebo, in subjects with a history of~     recreational marijuana use.~   "
171269|NCT01323556|"~     Investigation of mechanisms of exposure based learning by~        1. Investigating the effects of fear augmentation by interoceptive exposure during in vivo~          exposure~        2. Disentangling the effects of interoceptive exposure exercises in panic disorder~   "
171270|NCT01323543|"~     The safety and performance of the Elaspine™ Implant System in the treatment of lower back~     pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing~     clinical study (PMCS). The study will be enrolled within Germany and Switzerland in 3-5~     clinical centres, including in average 10 patients per centre. The study is conducted in~     accordance with the Standard ISO 14155, where applicable on clinical investigation of medical~     devices for human subjects and other legal requirements.~   "
171271|NCT01323530|"~     This is a Phase 1b/2, multi-center, open-label, dose escalation and dose-and-schedule~     confirmation study of eribulin administered in combination with capecitabine.~   "
171272|NCT01323517|"~     The purpose of this study is to see the effect of adding a systemic study drug, Ipilimumab,~     to two standard chemotherapy drugs, Melphalan and Dactinomycin. The study drug Ipilimumab is~     an antibody to a normal protein found in the body, CTLA-4. This protein normally allows the~     immune system (the body's natural defense system that helps fight infections) uses to quiet~     an immune response. The study drug works by blocking this protein and allowing the immune~     system to become more active. This study will investigate the effects, of combining ILI~     (using two standard drugs to treat melanoma, Melphalan and Dactinomycin), with the study~     drug, Ipilimumab on advanced Melanoma cancer.~   "
171273|NCT01323504|"~     It is estimated that 800,000 people in France suffer from peripheral artery disease (PAD), of~     whom 1-2% present the most severe form critical limb ischaemia (CLI). In this situation, the~     patient frequently presents painful non-healing ulcers and focal gangrene. Wound care is~     generally associated with increasing pain. Pain relief may be challenging in spite of major~     analgesics.~      Several studies in this country and elsewhere assessed the usefulness of music for chronic or~     acute pain relief during care. However, no data are published regarding the interest of music~     therapy for pain relief during local care in PAD patients.~   "
171274|NCT01323491|"~     The actually most accepted method of effective smoking cessation is based on structured~     consultation and medical care in combination with supportive medical treatment. A group of~     experts developed the concept EINFACH ERFOLGREICH RAUCHFREI (EASY EFFECTIVE SMOKELESS)~     for general practitioners providing a structured compendium for negotiation.~      Physicians who have implemented this concept will conduct this non-interventional study. The~     implementation of the scheme will be investigated under general practice conditions and the~     applicability of the concept has to be assessed by the physicians.~      In addition further knowledge of smoking cessation in would-be non-smokers which decided to~     quit, supported by medical treatment with NICORETTE®-products, will be documented for a large~     patient collective under real practice conditions.~      To answer all above mentioned questions for a sufficient number of patients a multicenter,~     prospective non-interventional study design was used for this trial as only this instrument~     detects characteristics of the physicians' treatment without any further input or other~     influences.~   "
171275|NCT01323478|"~     To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of~     Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)~   "
171276|NCT01323465|"~     Study to assess the effect of rifampicin, ketoconazole and omeprazole on the pharmacokinetics~     of a single dose of Sativex and to evaluate the safety of Sativex when given in combination~     with these other drugs.~   "
171277|NCT01323452|"~     The primary aim of this study is to asses the efficacy (both virological and clinical) and~     safety of ETV in both NA-naïve and NA-experienced chronic hepatitis B patients, and to~     explore baseline factors associated with virologic reponse (VR) to ETV.~   "
171278|NCT01323439|"~     This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the~     Axium MicroFX coil system in 100 aneurysms.~   "
171279|NCT01323426|"~     This pilot study examines safety and efficacy of a simple procedure for treatment of stress~     urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the~     urethral sphincter.~   "
171283|NCT01323374|"~     A correlation between increased norepinephrine concentration in the central nervous system~     (CNS) and a decrease in fibromyalgia pain has been suggested in clinical studies. Therefore,~     as a pro-drug of norepinephrine, droxidopa could potentially benefit fibromyalgia patients by~     reducing pain as a result of increasing CNS levels of norepinephrine.~      As this benefit is presumed to be a central effect, the addition of carbidopa, a peripheral~     DOPA decarboxylase (DDC) inhibitor, may favorably impact the drug's treatment profile.~     Carbidopa is utilized as a blocker of peripheral DDC, an enzyme required for the conversion~     of droxidopa into norepinephrine. Therefore, inhibition of peripheral DDC should result in a~     reduction of any side effects resulting from the peripheral production of norepinephrine,~     whilst allowing for increased central levels, and hence, increased centrally mediated~     benefits.~      The purpose of the study is the obtain information regarding the proper dosing, effectiveness~     and safety of droxidopa and combination droxidopa/carbidopa treatments in patients with~     fibromyalgia.~   "
171284|NCT01323361|"~     The study aims to show variation in CA-125 and other inflammatory markers assumed to be a~     response to trauma and peritoneal inflammation in the perioperative period of laparoscopic~     ventral hernia repair~   "
171285|NCT01323348|"~     The purpose of this study is to assess whether glycemic control (assessed with HbA1c~     measurement) in individuals with type 1 or type 2 diabetes can be improved with a~     point-of-care measurement of HbA1c in the ophthalmologist's office combined with a~     personalized risk assessment for diabetic retinopathy and other complications of diabetes.~   "
171286|NCT01323335|"~     Background:~      - Uric acid is a substance found in the blood that may contribute to certain chronic medical~     conditions and disorders, such as diabetes, insulin resistance, and high blood pressure. High~     uric acid concentrations have been associated with stroke and heart disease, as well as~     chronic heart failure. In particular, researchers are interested in determining the~     relationship between uric acid and inflammatory markers, or chemicals in the blood that can~     indicate inflammation and other problems with the body.~      Objectives:~        -  To study the specific effects of changes in uric acid in the body.~        -  To determine whether uric acid contributes to inflammation in the body.~      Eligibility:~      - Healthy individuals between 50 and 75 years of age.~      Design:~        -  This study will involve four visits: a screening visit, two study visits, and a followup~          visit.~        -  At the screening visit, participants will have a physical examination, blood and urine~          tests, and an electrocardiogram. Participants will be divided into two groups based on~          the existing amount of uric acid in their blood.~        -  Within 7 days of the screening visit, participants will have a full-day study visit with~          a magnetic resonance imaging scan, followed by a high-fat meal and further blood samples~          collected over the following 8 hours.~        -  At least 2 days after the first study visit, participants will have the second study~          visit, which will require a 2-night stay at the National Institutes of Health.~          Participants will have a metabolism test, and will receive the following infusions based~          on the groups they were assigned to at the screening visit.~        -  Group A (low uric acid) will receive either uric acid or a placebo.~        -  Group B (moderate to high uric acid) will receive either Rasburicase (a drug that~          reduces the amount of uric acid in the blood) or a placebo.~        -  After the infusions and related blood tests, participants will have a high-fat meal with~          further blood and urine samples.~        -  Approximately 2 weeks after the second study visit, participants will have a final~          followup visit with additional blood and urine tests to determine whether the levels of~          uric acid in the blood have returned to normal.~   "
171287|NCT01323322|"~     The Healthy Aging in Neighborhoods of Diversity across the Life Span study (HANDLS) is a~     multidisciplinary, community-based, prospective longitudinal epidemiologic study examining~     the influences of race and socioeconomic status (SES) on the development of age-related~     health disparities among socioeconomically diverse African Americans and whites in Baltimore.~     This study investigates whether health disparities develop or persist due to differences in~     SES, differences in race, or their interaction. This study is unique because it will assess~     over a 20-year period physical parameters as well as evaluate genetic, biologic, demographic,~     and psychosocial parameters of African American and white participants in higher and lower~     SES. It also employs novel research tools, mobile medical research vehicles, in hopes of~     improving participation rates and retention among non-traditional research participants. The~     domains of the HANDLS study include: nutrition, cognition, biologic biomarkers, body~     composition and bone quality, physical function and performance, sociodemographics,~     psychosocial, neighborhood environment and cardiovascular disease. Utilizing data from these~     study domains will facilitate understand the driving factors behind persistent black-white~     health disparities in overall longevity, cardiovascular disease, and cognitive decline.~      HANDLS recruited a fixed cohort as an area probability sample of Baltimore City from August~     2004 through November 2009 as Wave 1. HANDLS Wave 2 entitled The Association of Personality~     and Socioeconomic status with Health Status - An Interim Follow-up Study began in June 2006~     under a separate protocol. It was designed as a follow-up telephone interview approximately~     18 months after the initial examination (Wave 1) was complete. Wave 2 provided interim~     contact with study participants, and important interim information regarding their health.~     Now completed, waves 3 and 4 were the first and second follow-up examinations and~     participants second and third visit to our mobile Medical Research Vehicles (MRVs). The~     current protocol outlines Wave 5, the third follow-up examination and participants fourth~     visit to our mobile Medical Research Vehicles (MRVs). Planned as a follow-up after 3-4 years,~     Wave 5 consists of health examinations, questionnaires, a telephone dietary-recall interview,~     sensory assessments (visual, olfactory), health literacy assessment, skin color analysis,~     renal function assessments, environmental assessments and structural MRIs.~   "
171288|NCT01323309|"~     The aim of the study is to compare the benefits of three types of individual treatment~     programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and~     Enhanced Usual Care.~      We would like to train therapists in administering these types of counseling, so that they~     have expertise to work on the study. The therapists will administer either the~     Meaning-Centered counseling or the Supportive counseling, as part of their training.~      Many cancer patients use counseling or other resources to help with the emotional burden of~     their illnesses. Counseling often helps them cope with cancer by giving them a place to~     express their feelings. Meaning-Centered counseling aims to teach cancer patients how to~     maintain or even increase a sense of meaning and purpose in their lives, despite cancer.~     Supportive counseling is intended to help the patient cope with cancer by giving them a~     place to express their feelings and get support. Enhanced Usual Care is intended to offer the~     patient referrals and resources that are matched to their individual needs in addition to the~     care they are already receiving at MSKCC.~   "
171289|NCT01323296|"~     The investigators wish to examine whether a novel 'nanoparticle' of iron oxide, administered~     intravenously allows an area of heart muscle damage after heart attack to be visualised using~     a magnetic resonance scanner.~   "
171290|NCT01323283|"~     This study hypothesizes that supplementation of omega-3 fatty acids (OM3) can increase~     physical activity, inhibit rapid gain in body weight and BMI in both sedentary and normally~     active 8 year old children. The purpose is secondarily to explore patterns of associations~     between OM3 supplementation, baseline and follow-up levels in all studied parameters. The~     study also aims to study if basal levels of OM3 are correlated with physical activity and to~     study if there is an association between basal levels of OM3 and the effect of OM3~     supplementation on physical activity. To study if there is an effect of OM3 supplementation~     on triglyceride and LDL cholesterol levels and to study if there are more pronounced effects~     on children with higher levels. To study if OM3 supplementation, compared with placebo reduce~     weight increase among children at risk to become overweight. To study if there is an~     association between effects of OM3 on physical activity, weight and risk markers in blood. To~     study if there are any gender differences.~   "
172239|NCT01310699|"~     We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high~     definition white light colonoscopy will detect an increased number of nonpolypoid (flat and~     depressed) colorectal neoplasm.~   "
171292|NCT01323257|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     erythromycin or DRV/r on the steady-state pharmacokinetics of TMC435, the effect of a~     steady-state concentration of TMC435 (150 mg) on the steady-state pharmacokinetics of~     erythromycin and the effect of a steady-state concentration of TMC435 (50 mg) on the~     steady-state pharmacokinetics of DRV/r. We will also study the short-term safety and~     tolerability of TMC435 given alone and given togehter with erythromycin (Panel 1) or DRV/r~     (Panel 2). Steady state is a term that means that the drug has been given long enough so that~     the plasma concentrations will remain the same with each subsequent dose. TMC435 is being~     investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics~     (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and~     eliminated from the body.~   "
171293|NCT01323244|"~     The purpose of this study is to investigate the efficacy of a treatment with TMC435 in~     combination with peginterferon alfa-2a and ribavirin in patients who did not clear their~     hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial~     conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed~     against hepatitis C virus (HCV) were evaluated for short periods of time.~   "
171294|NCT01323231|"~     The objective of this study is to build upon preliminary research and conduct a pilot~     feasibility randomized controlled trial on a promising culturally-grounded and~     gender-specific treatment program, the XY-Zone. The central hypothesis underlying this study~     purports that through receiving the XY-Zone treatment, adolescents will decrease their risk~     for dropping out of school. This hypothesis is supported by two years of preliminary data~     investigating the effectiveness of the XY-Zone.~      To test the central hypothesis, the following specific aims will be pursued:~        1. Identify school dropout risk and protective factors (protective factors defined as:~          adult support and peer support; risk factors defined as: low school attendance,~          inability to achieve grade promotion, substance use, delinquency, school~          disconnectedness, misbehavior, disconnection from healthy peers) directly changed as a~          result of XY-Zone intervention.~        2. Determine the extent to which moderating variables (affective strength, duration in the~          program, family functioning, interpersonal strength, intrapersonal strength, level~          achieved in the program, and resiliency) effect change in outcome variables (risk and~          protective factors).~        3. Identify participants' beliefs about the impact of the mechanisms of change (respect,~          responsibility, relationship, role modeling, and reaching out) on outcome variables~          (risk and protective factors ) to enrich understanding of quantitative data.~   "
171295|NCT01323218|"~     Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with~     multiple comorbidities.~      OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation~     (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity.~     However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus~     and/or unstable neuromuscular output seem to be involved in this collapsus.~      A normal vitamin D status is necessary for normal muscle function and neuromuscular output.~     As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to~     evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.~   "
171296|NCT01323205|"~     The purpose of this study is to explore the safety, tolerability, and potential clinical~     efficacy of JNJ 40411813 in schizophrenic patients.~   "
171297|NCT01323192|"~     The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses~     of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to~     placebo.~   "
171298|NCT01323179|"~     Observational study evaluating pain response after total knee arthroplasty (TKA) in patients~     taking strong, weak or no opioids preoperatively.~   "
171299|NCT01323166|"~     The purpose of the study is to compare self-reported health related quality of life after two~     different operating techniques for low rectal cancer operated by rectal amputation, using a~     specific and detailed questionnaire. The population has been operated over a 6 year period in~     one university hospital.~   "
171300|NCT01323153|"~     This double-blind, randomized, placebo-controlled, multi-center study will evaluate the~     safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome~     (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized~     to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time~     on study treatment is 20 weeks.~   "
171301|NCT01323140|"~     Watson's testosterone transdermal system delivers male sex hormone through skin for the~     treatment of men with sex hormone insufficiency.~   "
171302|NCT01323127|"~     The main objective of this study is to investigate the influence of seat type (straight chair~     versus ergonomic chair) on the sagittal alignment of the lumbo-pelvic complex in two~     different postures compared to standing for each individual in both a chronic-back-pain and a~     non-chronic-back-pain population.~   "
171303|NCT01323114|"~     Type 2 diabetes mellitus is a chronic disease with severe long-term health consequences. In~     patients with type 2 diabetes mellitus who are also morbidly obese, an abundance of clinical~     evidence exists showing that significant clinical improvement in their diabetes occurs~     following certain types of bariatric, or weight loss, surgical procedures. There is~     additional data showing that bariatric surgical procedures that bypass the beginning of the~     small intestine, such as the Roux-en Y gastric bypass, can markedly improve type 2 diabetes~     even before significant weight loss has occurred. This early effect on type 2 diabetes prior~     to weight loss suggests that bypassing the beginning of the small intestine in patients who~     are not morbidly obese may also treat type 2 diabetes. There have been small studies outside~     the United States that support the concept of treating type 2 diabetes with a surgical~     procedure that bypasses the beginning of the small intestine without causing significant~     weight loss; however, data is limited in the United States and a call for comparative studies~     has been made internationally. The investigators propose to compare, in patients who are not~     morbidly obese, conventional medical treatment of type 2 diabetes to surgical treatment of~     type 2 diabetes using a bypass procedure that does not cause significant weight loss, the~     laparoscopic duodenal exclusion.~   "
172049|NCT01313286|"~     The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms~     of how much gets into the blood stream and how long it takes the body to get rid of it.~     Information about any side effects that may occur will also be collected.~   "
171304|NCT01323101|"~     Doxycycline is known to exhibit immune modulatory activities beyond its antibacterial~     effects. In particular, doxycycline is a potent inhibitor of matrix metalloproteinase 9,~     which is a protease derived largely from neutrophils. Recent studies demonstrate a~     significant correlation between pulmonary disease severity and sputum concentrations of MMP-9~     in patients with CF. In addition, sputum MMP-9 levels are associated with airway remodeling~     in CF.~      The goal of this study is to determine the therapeutic potential of doxycycline in modulating~     host airway inflammation in patients with CF. Specifically, the study will characterize the~     PK /PD of doxycycline, evaluate the safety of short term therapy, and explore the~     concentration effect relationship between doxycycline exposure and sputum biomarker levels.~   "
171305|NCT01323088|"~     In this randomized controlled trial, we will examine the effect of a 3-month exercise~     training (aerobic exercise versus resistance exercise) without calorie restriction on total~     and regional adiposity, ectopic fat in the liver and skeletal muscle, and risk of type 2~     diabetes in overweight girls.~   "
171306|NCT01323075|"~     The primary objective is to demonstrate a longer period of neurologic recovery from a sensory~     block assessed in each test group versus the group without metabolic disease.~   "
171307|NCT01323062|"~     This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended~     phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects~     with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).~   "
171308|NCT01323049|"~     The primary objective is to show that positive pressure extubation improves oxygenation~     immediately after extubation compared to extubation via aspiration by evaluating and~     comparing the onset time of desaturation during spontaneous ventilation during awakening~     following general anesthesia.~   "
171309|NCT01323036|"~     The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the~     blood following consumption of krill oil compared with fish oil and placebo.~   "
171310|NCT01323023|"~     Prescription for Health is a national program of The Robert Wood Johnson Foundation (RWJF) in~     collaboration with the Agency for Healthcare Research and Quality (AHRQ). A major goal of~     Prescription for Health is to measure the extent to which comprehensive strategies are~     effective in changing patient behavior and quality of life relative to four target health~     risk behaviors: diet, smoking, alcohol use, and physical activity. The funded projects will~     use a common set of survey instruments to help measure outcomes and draw overarching~     conclusions across projects. This study will only be analyzing aggregated data and does not~     have responsibility for recruitment of patients, randomization (if applicable), or~     interventions. Individual project designs may differ.~   "
171311|NCT01323010|"~     Metered dose inhalers with spacers are devices capable of providing higher rates of lung~     deposition of drugs such as beta agonists when compared to conventional nebulizers, but there~     is no consensus about the optimal dose when this is the device of choice and there is~     evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when~     compared to older children. Other factors that may interfere with response to albuterol~     treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious~     etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen~     that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children.~     Security of this new dosing regimen will be assessed by monitoring clinical side effects and~     serum levels of albuterol, but the investigators will also examine the presence of 12~     different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor~     genetics in the response to albuterol. The primary outcome measure will be the need for~     hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate~     and forced expiratory volume in the first second, the need for additional treatments and~     length of stay in the emergency room for those not hospitalized.~   "
171312|NCT01322997|"~     Stroke is the leading cause of disability in the United States. One of the reasons that it is~     so disabling is because of upper extremity hemiparesis (weakness in one arm), which is~     commonly seen after stroke.~      The objective of this research is to see if a robotic system worn on the weakened arm like a~     brace is more useful in improving the strength and coordination of the affected arm, and~     those of other stroke survivors, than therapy only. Muscle weakness and lack of coordination~     after a stroke have great effects on how severely disabled the arm is and on quality of life~     after a stroke.~      In this study, patients may be administered a new robotic brace as part of treatment for~     their affected arms. If they use this brace, your electromyography (EMG) signals will be used~     to control the powered arm brace. EMG signals are the small electrical signals that result~     from the actions of the muscles. The system will listen to patients' muscles, using small~     sensors that sit on top of the skin. The device will give the arm a power-assist when~     patients bend or straighten their elbows. The investigators want to test how easy and~     effective this system is to use. The investigators hypothesize that people using the robot~     will be more successful in their rehabilitative efforts - and that their movement will~     improve more - than people receiving traditional therapy.~   "
171313|NCT01322984|"~     Children and youth diagnosed with autism spectrum disorder (ASD) have been shown to react~     abnormally to social stimuli, especially to human faces. Children and youth with ASD show~     less interest in social stimuli, and may even avoid looking at or interact with such stimuli.~     It has been proposed that social stimuli elicit reactions like fear and stress in individuals~     with ASD, and this explains the lack of interest and avoidance. The present project~     investigates this hypothesis.~   "
171314|NCT01322971|"~     Bacterial vaginosis (BV) is a common vaginal infection characterized by a pathologic shift in~     the normal vaginal flora. BV has been associated with a number of poor reproductive outcomes,~     including infertility, preterm labor and premature rupture of membranes. If BV does disrupt~     normal embryologic development, then the treatment of BV prior to conception may improve~     implantation rates and other pregnancy outcomes in the infertile population.~      This is a prospective, randomized, double-blind, placebo-controlled trial in which infertile~     women undergoing intrauterine insemination or embryo transfer are screened for BV prior to~     treatment. Those patients who screen positive for BV will then be randomized into the~     treatment arm(metronidazole 500mg by mouth twice daily for 7 days) or the control arm~     (placebo by mouth twice daily for 7 days). The primary outcome, positive pregnancy test rate~     (i.e. biochemical pregnancy rate), will then be assessed. Secondary outcomes, such as~     clinical pregnancy rate, miscarriage rate, and live birth rate will also be examined.~   "
171316|NCT01322945|"~     The purpose of this study is to evaluate patient nasal outcome following endo-nasal surgery.~     This type of surgery is conducted for pituitary and skull base tumors. There is no published~     data on trauma to the nose during surgery and how it impacts nasal functioning. The~     investigators propose to develop a survey and administer it to patients before and after~     surgery to learn about their perception of nasal functioning.~   "
171317|NCT01322932|"~     The purpose of this study is to assess adherence, tolerability and satisfaction of each~     eligible HIV subjects switching from a two- or three-pill tenofovir-emtricitabine-efavirenz~     (TDF-FTC-EFV) to a one-pill TDF-FTC-EFV treatment.~   "
171318|NCT01322919|"~     By using a new software two consecutive laser treatments have been combined to correct the~     distance vision and to provide a near vision component in addition to the first treatment.~      This study will help us to answer 2 questions:~        1. How accurately this combined technique corrects distance and near vision~        2. Whether the correction is adequate to remove the complete need for supplementary near~          spectacles~   "
171319|NCT01322906|"~     Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure~     Caused by hepatitis B virus (HBV)~   "
171320|NCT01322893|"~     Women with metastatic breast cancer, receiving first line treatment of any kind~     (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this~     trial. In connection to treatment, blood samples for determination and enumeration of~     circulating tumour cells will be collected at different time points. Serum and plasma will be~     collected and stored for future analysis of RNA and DNA.~   "
171321|NCT01322880|"~     Over the last twenty years micro-finance based interventions have proven to be a popular and~     often effective means of improving the economic outcomes of impoverished women. However, the~     gains to microfinance based interventions on women's decision making in both economic and~     non-economic arenas remains largely unknown. Specifically, the question of to what extent~     does access to small-scale credit alone, rather than other programs often combined with~     microfinance, affect women's empowerment is of particular interest when determining~     interventions in a variety of setting in developing nations. There exists evidence that~     women's empowerment is associated with reduced violence and as such maybe an important tool~     for improving adult women's wellbeing. In addition increased decision making power by women~     has been associated with improvement in children's health outcomes, especially for girls, and~     as such may be way generating intergenerational improvements in women's outcomes.~      The goal of this project is to disentangle the effects of access to credit alone from the~     information on financial and personal decision making that is frequently coupled with these~     programs. To accomplish this, the investigators use a randomized field experiment among~     participants in Village Savings and Loans Associations (VSLA's). VSLA participants are a~     self-selected group of people who pool their money into a fund from which members can borrow.~     The money is paid back with interest, causing the fund to grow. The regular savings~     contributions to the VSLA are deposited with an end date (usually less than 1 year) after~     which all or part of the total funds are distributed to the individual members. The small~     loans are paid back with interest which is determined by the group at the time of formation~     and the returns from these interest payments are also distributed to the groups. The~     investigators then test whether there are additional gains to women's well-being by providing~     VSLA participants with training on process-based decision making to determine if there is a~     need for additional efforts to improve the decision making structure in households. To the~     extent that increased access to credit and more broadly financial resources is limited by~     existing constraints on women's decision making power, this additional training may be a~     necessary part of the creation of credit markets in improving the health and well-being of~     women and children.~   "
171322|NCT01322867|"~     A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine~     Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral~     Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form,~     Under Fasted Conditions in Healthy Volunteers.~   "
171323|NCT01322854|"~     The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial~     comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy~     with consecutive boost in patients with breast cancer after breast conserving surgery. 502~     patients will be recruited and randomized in two arms: patients in arm A will receive IMRT in~     28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor-bed by an integrated~     boost, while patients in arm B will receive conventional radiotherapy of the breast in 28~     fractions to a dose of 50.4 Gy and a consecutive boost in 8 fractions to a total dose of 66.4~     Gy. Primary aim of the study is the assessment of the cosmetic outcome and local control~     after breast radiotherapy. The study hypothesis is that intensity modulated radiotherapy~     (IMRT) is, in spite of the reduced treatment duration, at least equivalent to conventional~     therapy.~   "
171324|NCT01322841|"~     The CHICA system is a clinical decision support system that uses adaptive turnaround~     documents to provide point-of-care information to clinicians. The investigators will be~     studying whether it can help in the diagnosis and treatment of tuberculosis and iron~     deficiency anemia.~   "
171325|NCT01322828|"~     The purpose of this study to to determine whether a single incision technique or a double~     incision technique is more effective in the surgical treatment of distal bicep tendon~     ruptures. Patients will be randomized to one of the two techniques upon consenting to the~     study. Prior to surgery patients will have their elbow flexion, extension, pronation, and~     supination strength measured. Elbow Range of motion will also be measured in each of these~     four movements. A number of subjective questionnaires will also be administered to the~     patient prior to surgery. The identical objective tests and subjective questionnaires will be~     completed by the patient at intervals of three months, six months, one year, and two years~     following their surgery. Additional information from patients clinical visits may also be~     collected throughout the study.~   "
171326|NCT01322815|"~     The purpose of this study is to test the safety of GI-4000 and see what effects (good and~     bad) it has against cancer over time. This study is also being done to measure the immune~     response to GI-4000. Study drug will be given in addition to a standard of care which is a~     standard therapy given to patients with your type of cancer (colon).~   "
171327|NCT01322802|"~     This phase I trial is studying the side effects of vaccine therapy in treating patients with~     stage III-IV or recurrent ovarian cancer. Vaccines made from deoxyribonucleic acid (DNA) may~     help the body build an effective immune response to kill tumor cells.~   "
171328|NCT01322789|"~     Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing~     pancreatic β-cells. The autoimmune response begins months or even years before the~     presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or~     acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells~     showed promising results in regulating immune system and promoting some degree of disease~     control. The aim of our study is to determine the safety and efficacy of intravenous~     infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.~   "
172240|NCT01310686|"~     To obtain a genotypic analysis of patients with chronic exudative age-related macular~     degeneration noted to have subretinal or intraretinal edema despite continuous monthly~     Anti-VEGF therapy.~   "
171329|NCT01322776|"~     This is a multi-center, single arm, open-label, prospective IIS study, which will enroll 40~     recurrent MCL patients.The aim is to evaluate the efficacy and safety of bortezomib,~     fludarabine and cyclophosphamide treatment and also analyze the relationship between NF-kB~     activity and efficacy of bortezomib treatment and whether NF-kB activity can predict MCL~     progression.~   "
171330|NCT01322763|"~     Principal aim: To determine the prevalence of Sleep Apnea- Hypopnea syndrome in obese~     children.~      Secondary aim: 1. To fix the implication of the adenotonsillar hypertrophy, the obesity and~     the hormonal factors in the pathogeny of SAHS in children. 2. To determinate of clinical and~     neurophysiologic characteristics of childhood SAHS associated with obesity. DESIGN: A~     prospective transversal study.~   "
171331|NCT01322750|"~     With an estimated > 2 million women with undetected breast cancer in the United States, the~     need for improved early detection is imperative. Early diagnosis for these women is key to~     minimizing quality life-years lost to disease and optimizing success of treatment. Evidence~     now exists supporting the finding that systemic spread is an early event in the natural~     history of breast cancer, manifested as a release of single cancer cells from the incident,~     clinically undetectable tumor, which circulate through the bloodstream and deposit within~     remote tissues. Reliable and accurate detection of these circulating tumor cells (CTCs) is~     now possible with a simple peripheral venous blood draw. This study hypothesizes that women~     with CTCs and no other signs of malignancy have clinically undetectable disease.~      This study will attempt to validate this technology as a breast cancer screening test and~     acquire data to determine the clinical validity and utility of this proposed screening~     methodology on a relatively young, ethnically diverse population who are eligible military~     health care beneficiaries. Furthermore, this study will attempt to bank identified CTCs in~     order to perform additional molecular analyses in the future. The specific aims are to~     develop a simple, reliable, cost-effective, and clinically relevant breast cancer screening~     test in order to identify subclinical disease early in its natural history in subjects at~     risk of progression to clinically apparent disease over the ensuing decade. The ultimate goal~     is to decrease the treatment-related morbidity and cause-specific mortality of breast cancer.~     An experienced team devoted to the care of patients with breast disease has been assembled to~     achieve this goal.~   "
171332|NCT01322737|"~     This feasibility trial will evaluate the ability of the SuMO Tissue Access and Resection~     System (Apollo Endosurgery, Austin, Texas). The SuMO System utilizes balloons to create a~     submucosal pocket and electrosurgical cutting device to resect the mucosa. The SuMO elevates~     the tissue from the underlying muscularis using a balloon to distend the submucosa, similar~     to what is currently performed with injectable saline in a standard EMR. After dissection of~     the lesion, a separate cutting device will be utilized to resect the tissue by cutting around~     the border of the targeted tissue. If needed, a standard loop snare will be used to complete~     the mucosal resection.~   "
171333|NCT01322724|"~     The purpose of this study will be to determine if the temperature of water used during~     insertion of colonoscopy makes a difference in patient discomfort and sedation requirements.~     The hypothesis of this study is patients receiving screening colonoscopy utilizing the water~     insertion method with room temperature (cool) water will have similar pain scores and~     medication requirements compared to water insertion method using body temperature (warm)~     water.~   "
171334|NCT01322711|"~     Primary and secondary prevention trials with statins, as well as with antiplatelet, clearly~     demonstrated that these drugs are able to reduce cardiovascular events. Even if the principal~     mechanism of action of statins is to lower cholesterol, other effects, the so-called~     pleiotropic effects, have been considered as adjunctive properties potentially accounting for~     the anti-atherosclerotic effect of statins.~      Inhibition of oxidative stress may be considered an intriguing pleiotropic effect in view of~     the fact that oxidative stress is thought to be a key event in the initiation and progression~     of atherosclerotic disease. Reduction of several markers of oxidative stress including~     isoprostanes, 8-hydroxydeoxyguanosine (8-OHdG), and nitrotyrosine have been observed after~     statin treatment. NADPH oxidase is among the most important sources of reactive oxygen~     species involved in atherosclerotic disease. The investigators developed an ELISA to evaluate~     serum levels of soluble-gp91phox, the catalytic core of phagocyte NADPH oxidase. Recently the~     investigators showed that statins (30 days treatment) exert an antioxidant effect via~     inhibition of soluble gp91phox expression.~      The exact mechanism by which atorvastatin reduces NADPH oxidase, however, is unclear. Recent~     study showed that statin treatment inhibits leukocyte ROCK activity, a protein kinase~     implicated in the activation of NADPH oxidase, with a mechanism that seems to be independent~     from lowering cholesterol. To further study the mechanism(s) implicate in gp91phox~     downregulation by statin the investigators planned the present study in patients with high~     risk of vascular events such as hypercholesterolemic and Type 2 Diabetes mellitus patients.~      In addition the investigators want to evaluate the synergistic role of atorvastatin with~     aspirin treatment.~   "
171335|NCT01322698|"~     Our primary objective is to evaluate the relevance of the early determination of Candida~     infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.~   "
171336|NCT01322685|"~     The purpose of this study is to study the Development and Application of Rapid Nucleic Acid~     Diagnostic Kits for Clinical Specimens. Subjects are divided into two groups which are health~     group and Tuberculosis or lung cancer group in order to compare with the difference.~   "
171362|NCT01322334|"~     Upper airway resistance during sleep can present with a range of symptoms from simple snoring~     (SS) through to severe obstructive sleep apnea (OSA). Pharyngeal narrowing or collapse leads~     to reduction or cessation in airflow during sleep, and is associated with loud snoring.~      The investigators hypothesized that regular singing exercises could strengthen pharyngeal~     muscles and/or increase their resting tone, and lead to an improvement of symptoms and thus~     quality of life in patients with all forms of snoring.~   "
171363|NCT01322321|"~     This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a~     mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.~   "
171364|NCT01322308|"~     The present study aims to investigate the effect of pioglitazone (30 mg/day) on endothelial~     function in premenopausal women with SLE (systemic lupus erythematosus). Patients with~     hypertension, endocrine, hepatic or renal diseases will not be included, or pregnant /breast~     feeding women. This is a randomized, double blind, placebo controlled study.~   "
171337|NCT01322672|"~     Recent data suggests that anesthetics can have prolonged effects on gene expression, protein~     synthesis and processing as well as cellular function in ways that the investigators are only~     beginning to understand, especially in the very young and the elderly. Within moments to days~     of emerging from anesthesia - cardiac or non-cardiac - some patients experience mild to very~     severe disorientation and changes in memory and thinking ability without apparent cause. For~     the vast majority of patients, this Post-Operative Cognitive Dysfunction (POCD), generally~     subsides, but for some with diminished cognitive reserve - especially the elderly, those~     with less education or prior CNS events such as stroke or early dementia - changes in memory~     and executive function may persist. If prolonged for more than three months, POCD has been~     linked to an increased risk of death. In 1-2% of elderly patients, the problem may ultimately~     continue for more than a year, leading to a loss of ability to care for themselves and early~     demise. Though this may seem like a small percentage, seniors will comprise up to 40% of the~     50-75 million surgical procedures performed annually over the next 20-30 years. This amounts~     to 70,000 - 200,000 elder affected, and for them and their families, the cost of POCD in~     longer-term care, lost wages, and extended suffering will remain very high.~   "
171338|NCT01322659|"~     The purpose of this study is to determine whether helmet is effective as device for~     noninvasive positive pressure ventilation in the weaning from mechanical ventilation.~   "
171339|NCT01322646|"~     There is clear, converging evidence from multiple prospective studies with well-diagnosed~     adolescents with ADHD and comparison, non-ADHD adolescents, that teen drivers with ADHD have~     more accidents and other adverse driving outcomes. Available research indicates parental~     monitoring and limit-setting for adolescent drivers is one of the most effective~     interventions for preventing negative driving outcomes. For children with ADHD, interventions~     to promote parenting capacity to effectively oversee and intervene in teen driving will~     likely need to be intensive and require multiple treatment components. The present proposal~     aims to compare the standard care for teen drivers (driver's education classes and driving~     practice) to the Supporting a Teen's Effective Entry to the Roadway (STEER) program, that~     includes a parent-teen intervention, adolescent skill building, parent training on effective~     adolescent management strategies, joint parent-teen negotiations sessions, practice on a~     driving simulator, parental monitoring of objective driving behaviors, and the targeting of~     safe teen driving via contingency management strategies (i.e., parent-teen contracts). To~     facilitate teen and parent engagement the intervention will be preceded by a motivational~     interview. The specific aims of the proposal are to investigate the efficacy of the STEER~     program relative to a standard care group in a randomized clinical trial (N=172) on measures~     of objective driving outcome and parenting capacity. It is hypothesized that the STEER~     program will result in improved outcomes relative to the standard care group at the end of~     intervention and 6 and 12 month follow-up assessments.~   "
171340|NCT01322633|"~     The primary objective is to assess whether the risk of gastric cancer is increased in~     pantoprazole users compared to users of other proton pump inhibitors.~   "
171341|NCT01322620|"~     This study is conducted in Africa, Asia, Europe, North America and South America.~      The purpose of the survey is to identify the key psychosocial issues affecting patients with~     haemophilia.~   "
171342|NCT01322607|"~     Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an~     extremely high energy cost of movement and contributing to overall disability and lower~     quality of life. Therefore, interventions targeting movement economy should be developed for~     those in the chronic phase of stroke recovery. This study is designed to compare the effect~     of two distinctly different exercise paradigms (a higher-intensity treadmill training program~     and a lower-intensity group exercise program) on economy of movement during over-ground~     walking and activities of daily living, as well as the extent to which gains in muscular~     strength, muscular endurance, and balance predict changes in movement economy.~   "
171343|NCT01322594|"~     Phase I study to evaluate the safety and tolerability of single ascending intravenous doses~     of MEDI2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease~     (COPD).~   "
171344|NCT01322581|"~     Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality~     worldwide. A malaria vaccine would contribute towards efforts to control and eliminate~     malaria. Optimism that an effective malaria vaccine can be developed is derived in part from~     the observation that repeated Pf infections can induce protective immunity; however, the~     mechanisms underlying acquired malaria immunity remain unclear. The goal of the current study~     is to apply systems biological tools to an observational cohort in an area of intense~     seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired~     malaria immunity. This year-long observational-cohort study of 700 individuals (3 months and~     25 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf~     transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be~     detected by passive and active surveillance. Immune parameters of malaria-protected and~     -susceptible individuals will be assayed from blood samples collected at strategic time~     points relative to the malaria season. The primary objective is to identify genome-wide~     expression profiles induced by Pf infection that are associated with protection from malaria.~     Secondary objectives include identifying age-related (surrogate for cumulative Pf exposure)~     changes in Pf-induced gene-expression and serum cytokine profiles, and examining Pf-specific~     antibody profiles that are associated with protection from malaria using a protein microarray~     representing 2000 Pf proteins (40 percent of the Pf proteome). Exploratory objectives for~     this study are to compare the magnitude and quality of the Pf-specific CD4 plus T cell~     response in malaria-protected and -susceptible individuals and determine how this response~     varies with age and among individuals before, during, and after malaria season, as well as~     compare various immune parameters in Pf-infected and uninfected individuals at the end of the~     dry season to investigate host immune factors associated with chronic asymptomatic Pf~     infection.~   "
171345|NCT01322568|"~     Background:~      - Researchers are interested in studying the environmental and genetic factors that play a~     role in health and living conditions as people age. Since 2002, the U.S. National Institute~     on Aging and the Icelandic Heart Association Research Institute have been conducting a~     long-term study known as the Research in Aging project to collect personal data and samples~     from Icelandic men and women in order to study risk factors related to disease and disability~     in old age. Researchers plan to initiate a second stage of the study.~      Objectives:~      - To collect additional personal information, medical records, and blood samples from~     individuals who have previously provided materials for the Research in Aging Project in~     Iceland.~      Eligibility:~      - Individuals who have previously participated in the Research in Aging project in~     association with the U.S. National Institute on Aging and the Icelandic Heart Association~     Research Institute.~      Design:~        -  Participants will have a physical examination with imaging analysis procedures and~          hearing and eye tests, provide information on health and diet, and provide a 100-ml~          blood sample for testing.~        -  Participants will also provide consent for researchers to consult data and samples~          collected during the first stage of the Research on Aging project.~   "
171346|NCT01322555|"~     Background:~      - People with autism and autism spectrum disorders have problems with communication,~     behavior, and socializing, and many also have intellectual and developmental disabilities.~     The cause of autism is not known, but previous research has suggested an association between~     autism and immune changes in the brain. Researchers are interested in using the experimental~     radioactive drug (11C)PBR28, which attaches to a protein in the brain that is involved in~     immune changes, in positron emission tomography (PET) scanning of people with and without~     autism to see if there are greater immune changes in those with autism.~      Objectives:~      - To determine if positron emission tomography scanning can be used to evaluate changes in an~     immune system protein in the brains of people with autism.~      Eligibility:~      - Individuals between 18 and 45 years of age who have been diagnosed with either autism or~     autism spectrum disorders, or are healthy volunteers.~      Design:~        -  Participants will be screened with a physical examination and psychological examination,~          medical history, questionnaires about behavior and mood, and blood and urine tests.~        -  Participants will have two imaging studies of the brain at separate study visits. The~          first study visit will involve a magnetic resonance imaging (MRI) scan to provide a~          baseline image of the brain. The second study visit will involve PET scan with the~          radioactive chemical (11C)PBR28 to study immune system proteins in the brain. The MRI~          scan will take about 40 minutes, and the PET scan will take about 2 hours.~        -  Participants will have a final study visit 24 hours after the PET scan to provide a~          final blood sample for testing.~   "
171347|NCT01322529|"~     Forty percent of pregnant women in the United States are women who have never given birth. As~     a group, they sometimes have complications with their pregnancy, but there is no information~     from a previous pregnancy to identify who might have a problem. Very little research has been~     done with this group. The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be~     (nuMoM2b) is collecting data from a diverse population of about 10,000 women who are having~     their first baby and are carrying only one baby. The women are enrolled early in pregnancy~     and undergo research assessments four times during their pregnancies. Data are collected~     through interviews, self-completed data forms, clinical measurements, ultrasound, and~     collection and storage of blood samples, urine samples, and fluid from the vagina and cervix.~     Some information comes from medical records. A subset of women may be asked to participate in~     substudies collecting information on sleep breathing, sleep patterns and quality, or other~     areas possibly related to birth outcomes. The goal of the research is to find ways to~     identify women in this group who might develop a problem with their pregnancy and use this~     information to improve the health of pregnant women and their babies in the future. The study~     is focusing on pregnancy problems like high blood pressure, babies that are born much too~     early and very small babies.~   "
171348|NCT01322516|"~     We propose to follow a cohort of pregnant and post-partum Canadian women through the fall and~     winter of 2009/2010 and the anticipated second and third waves of the current pandemic in~     order to better understand the incidence, complications and risk factors for severe disease~     due to H1N1 influenza in pregnant women, and to contribute data on the safety and~     effectiveness of antivirals and vaccines in this population.~      The primary hypotheses to be tested are:~      (i) pandemic influenza infection in the second and third trimester of pregnancy is associated~     with an increase in adverse fetal outcomes (fetal loss, stillbirth, neonatal mortality,~     significant neonatal morbidity, prematurity) (ii) close contact with young children (<2 yrs)~     at home or work is the most important risk factor for influenza in pregnant women (iii)~     higher scores on a scale of community infection prevention (a combination of self-reported~     hand hygiene adherence, avoidance of ill persons and avoidance of crowds) are protective~     against influenza (iv) receipt of seasonal influenza vaccine from 2007 to 2009 will increase~     the risk of illness due to influenza A(H1N1)v in the second and third waves of the pandemic.~      (v) pandemic influenza vaccine is effective in preventing symptomatic influenza in pregnant~     women.~      (vi) vaccination of pregnant women against a particular strain of influenza protects their~     infants against influenza infection in the first six months of life.~   "
171349|NCT01322503|"~     Objectives: To evaluate the role of human histo-blood group antigens in susceptibility to~     Norovirus infections.~      Description of Study Design: Healthy volunteers with different blood types and low antibody~     titers to the challenge strain will be challenged orally with a Norovirus in the CCCR~     inpatient facility. Subjects with resistant (non-secretors) or susceptible (secretors (of~     either A, B or O blood group)) to the challenge strain will be recruited. The challenge study~     will be conducted in two groups of twenty, each with approximately ten secretors and ten~     non-secretors. Three additional subjects per group will serve as alternates in the event that~     any of the study subjects are unavailable or become ineligible at the time of the inpatient~     study. Subjects will be monitored daily in the isolation facility for at least five days~     following this challenge for daily clinical and virological evaluations. Subjects will return~     to the investigational site for evaluation the day after discharge from the inpatient unit~     and about 30 days (28-35 days) post challenge.~      Study Endpoints: Norovirus infection as assessed by viral shedding, seroconversion and~     clinical illness assessed by the duration and severity of symptoms~   "
171350|NCT01322490|"~     The purpose of this study is to determine whether PROSTVAC alone or in combination with~     GM-CSF is effective in prolonging overall survival in men with few or no symptoms from~     metastatic, castrate-resistant prostate cancer.~   "
171365|NCT01322295|"~     Elective open aortic aneurysm repair has an overall reported 30 day mortality of 2-6 percent,~     but in patients more than 65-70 years the mortality is reported to be more than 10 percent.~     The phenomenon of acute lung injury (ALI)/adult respiratory distress syndrome (ARDS) after~     infra renal abdominal aneurysm repair caused by ischemia-reperfusion is well established. The~     degree of disability varies from a light degree of acute respiratory failure to mortality for~     patients with the same profile of risk.~      Primary aim is to develop a model that monitors inflammatory marker molecules collected from~     the bronchial epithelial lining fluid by microdialysis. The method with examination of the~     bronchial epithelial lining fluid by microdialysis and analysis of multiple inflammation~     markers as previously done by the investigators group.~   "
171366|NCT01322282|"~     This study is designed to assess bioequivalence between two products used for treatment of~     allergy.~   "
171367|NCT01322269|"~     The purpose of this study is to evaluate the safety and tolerability of three dose levels of~     HQK-1001 administered once daily for 26 weeks in subjects with sickle cell disease.~   "
171351|NCT01322477|"~     HCC (Hepato-cellular Carcinoma) is the fifth most frequent cancer in humans and its~     prevalence is growing. The most effective treatment of HCC is surgical and includes resection~     and liver transplantation; however, only 20% of the patients can be treated surgically. Local~     interventional therapy, such as radiofrequency (RF) ablation and transarterial embolization~     is also used.~      Recurrence rate is very high, and extrahepatic disease develops in about 30% of the cases and~     in up to 20% after liver transplantation.~      Systemic treatment is thus an option. Sorafenib (multi-kinase inhibitor) is the first agent~     to significantly improve the overall survival in advanced HCC. However, the drug has serious~     side effects and is very expensive.~      PET/CT with F18-FDG is a common tool for systemic evaluation and staging of various tumors.~      The value of the FDG PET for evaluation of HCC is controversial, in particular due to the~     unique metabolic pathway of glucose in the HCC cells. Since 2007 more and more studies~     suggest the feasibility of FDG PET/CT for monitoring local recurrence (especially after RF)~     and metastatic spread of HCC, including detection of active disease only suspected by AFP~     (alphafoetoprotein) elevation.~      Early detection of treatment response to therapy by whole body FDG PET/CT allows for change~     of treatment as early as possible,when the tumor is non-responsive before serious side~     effects appear or before depletion of body resources.~      The aim of our study is to investigate the contribution of FDG PET/CT to assessment of~     treatment response.~   "
171352|NCT01322464|"~     Study to assess effect of food on the bioavailability of a single dose of Sativex and to~     measure its' pharmacokinetics after a single and multiple doses.~   "
171353|NCT01322451|"~     The purpose of the study is to evaluate the relative bioavailability of two solid oral~     formulations of GLPG0259 administered after a meal.~   "
171354|NCT01322438|"~     The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how~     your body absorbs and distributes BAY73-4506.~   "
171355|NCT01322425|"~     The pathophysiology of pain related to fibromyalgia is not understood. This condition is~     difficult to diagnose and to treat. One clue may be that tender points (areas which hurt~     typical of fibromyalgia) are most densely located near the clavicles. This is also the area~     where brown fat is located in humans. Brown fat is typically used to maintain body~     temperature. Stress (such as cool temperature or special diets, i.e., high fat, low~     carbohydrate) appears to worsen the pain seen in fibromyalgia. We hypothesize that a~     mechanism for pain in this disease relates to activating brown fat through neural mechanisms.~     The nerves to brown fat also go into adjacent muscle and skin. So, when brown fat is turned~     on or increases in amount, collateral nerves may cause pain at the tender points.~      The central hypothesis is that stress such as temperature or diet will activate brown fat.~     Patients with fibromyalgia will have greater activation or volume of brown fat. Neuralgia~     related to stress may be the etiology of the pain. If this hypothesis is proven, there are~     several drugs on the market that could be deployed to correct these patients' problems.~     Therefore, this project, if successful, will lead to clinical trials of these drugs in~     fibromyalgia patients.~   "
171356|NCT01322412|"~     Physical exercise has been identified as a major item of many chronic diseases and cancer~     rehabilitation.~      Therefore, physical activity for health is a valid and relevant way to improve quality of~     life and to manage cancer patient fatigue. The aim of the study is the assessment of the~     effects of a physical activity retraining program on aerobic capacity, strength and fatigue,~     in a breast cancer population treated by adjuvant chemotherapy.~   "
171357|NCT01322399|"~     The primary purpose of study is the collection of feasibility data for a larger trial of~     Structural Integration (SI)(an alternative manual therapy) for chronic low back pain. The~     secondary purpose is the collection of preliminary data on 1) the therapeutic effect of SI~     plus usual care versus usual care alone - the hypothesis being the the effect size will be~     significantly greater in the SI plus usual care arm; and on 2) specific hypothesized~     mechanisms of that hypothesized therapeutic effect: a) improvements in cognitive behavioral~     factors; b) improvements in standing balance and gait, and c) improvements in selected blood~     biomarkers.~   "
171358|NCT01322386|"~     The goals of the proposed work are two fold:~      Firstly, to see if the antibiotic vancomycin may be used for the early treatment of Biliary~     Atresia (BA) and Primary Sclerosing Cholangitis (PSC). The investigators hope to learn what~     effect Vancomycin has on the bacteria that are present in stool, body fluid or intestinal~     tissue on someone who has BA and PSC and if so by what mechanism. Secondly, the investigators~     hope to learn to characterize human intestinal microbial communities (microbiome: the~     collection or collectivity of microorganisms) using molecular methods, examine the mechanisms~     of interaction between host and microbiome using genomic approaches, and determine how the~     microbiome both preserves local health and promotes pathology. The investigators will focus~     on primary sclerosing cholangitis, biliary atresia, as well as states of health. The~     composition of the associated microbiome will be assessed based on ribosomal DNA and RNA~     sequences, and attention will be given to richness (diversity), evenness (relative~     abundance), and variation with respect to time, person, and anatomic niche. Host response at~     the adjacent mucosal surface will be assessed based on genome-wide gene expression patterns.~   "
171359|NCT01322373|"~     This follow-up study is designed to obtain longitudinal clinical and MEG scan data to gain~     information on Alzheimer's disease (AD) progression, the stability of healthy control (HC)~     MEG scan data, to enrich the Orasi database of AD and HC subjects, and is intended to extend~     the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under~     development by the sponsor, Orasi Medical. The current study is intended to extend the~     database of AD and HC MEG scans and will include patients who previously enrolled and~     completed Orasi Protocol ADG 08-01. This study will include MEG scans on up to approximately~     50 AD subjects and 70 HC subjects. Additionally, AD subjects will complete 3 standard~     functional tests while HC subjects will complete 2 standard functional tests. ApoE genotyping~     also will be determined for all subjects. The results generated in this study will be used to~     improve the accuracy of the SNI test for diagnosing and tracking the progression of AD.~   "
171360|NCT01322360|"~     The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate~     in the treatment of postoperative pain in different pediatric age groups following~     multiple-dose administration.~      To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects.~      To compare plasma concentration of morphine sulfate in each age group of pediatric subjects~     with adult plasma morphine sulfate concentrations.~   "
171369|NCT01322243|"~     In this study, we would like to explore the hypothesis that changes in metabolic state,~     induced by altering hormone levels and patterns of neural activity, affect the experience of~     anxiety in humans. We will also investigate if there is a link between high anxiety and~     higher caloric intake. Our aim is to characterize whether changes in current metabolic state~     systematically influence anxiety induced by a well established behavioral task known as the~     threat of shock. The neural regions activated by this behavioral task in healthy subjects~     have been well characterized. We have a priori regions of interest that include the insula,~     anterior cingulate cortex, hypothalamus, amygdala, and prefrontal cortex. As our primary~     outcome, we will assess neural activation with whole-brain functional magnetic resonance~     imaging to determine whether brain regions are differentially engaged when subjects~     experience anxiety across different metabolic states. We will correlate these changes with~     psychophysiological measures of anxiety and metabolic state.~   "
171370|NCT01322230|"~     The purpose of this study is to compare the educational efficacy of instructional design~     enhancements in on-line learning modules in the context of clinical medical education.~   "
171371|NCT01322217|"~     This study will collect information on health status and risk behaviors, as well as basic~     demographic and biomedical information for a group of HIV positive adolescents receiving care~     at sites newly participating in ATN III.~   "
171372|NCT01322204|"~     The purpose of this study is to determine the absorption and bioavailability of codeine in~     relation to postnatal (PNA) and postconceptional (PCA) age; determine the parent drug~     (codeine), its active metabolites, their formation rates and their ratios in relation with~     PCA and PNA; and identify relevant genetic polymorphisms of opioid metabolism in the study~     population and their potential relationship to the biodisposition and pharmacodynamic effects~     of codeine. The study population is intubated and mechanically ventilated infants equal to or~     greater than 26 weeks gestational age at birth and less than 4 weeks postnatal age.~   "
171373|NCT01322191|"~     This study was originally undertaken to evaluate the analgesic efficacy of an intravenously~     administered dose of ketorolac compared with intravenous morphine in the relief of acute,~     postoperative pain in children admitted to the Intensive Care Unit. Using the urine and~     plasma samples originally collected from patients in the morphine treatment group and which~     were never analyzed, this proposal seeks to study the pharmacokinetics and metabolism of~     intravenous morphine in critically-ill children along with its concentration-related efficacy~     using prior measures of pain.~   "
171374|NCT01322178|"~     The aim of this study is to explore whether cetuximab in combination with mFOLFOX6 as~     treatment could improve the resection rate in patients with KRAS wild-type, unresectable~     liver metastases of mCRC.~   "
171375|NCT01322165|"~     The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular~     Conditions (GenTAC) was initiated in 2006 by the National Heart, Lung, and Blood Institute~     (NHLBI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases~     (NIAMS). GenTAC established a registry of 3706 patients with genetic conditions that may be~     related to thoracic aortic aneurysms and collected medical data and biologic samples. The~     study ended in September 2016. Data and samples are available from NHLBI and requests should~     be made to BioLINCC. See the NHLBI website for more information:~     https://www.nhlbi.nih.gov/research/resources/gentac/.~   "
171376|NCT01322152|"~     The objectives of this study are to evaluate the efficacy and tolerability of single-week~     regimen of irinotecan plus capecitabine in the first-line or second-line treatment of~     advanced colorectal cancer.~   "
171377|NCT01322139|"~     This study was to evaluate effects of Sativex on electrocardiogram (ECG) traces when~     administered at its therapeutic dose of 8 sprays per day and at multiples of the therapeutic~     dose (24 or 36 sprays per day), and to evaluate its safety and tolerability.~   "
171378|NCT01322126|"~     The purpose of this study is to determine whether use of the ultrasound to locate the~     epidural space and assist with performing neuraxial anesthesia will decrease numbers of the~     attempts required for successful placement of epidural catheter.~   "
171379|NCT01322113|"~     This study deals with the possible molecular mechanisms that underlie the etiology of bipolar~     disorders (BD). Previous studies have implicated Na+, K+-ATPase and endogenous digitalis-like~     compounds (DLC) in the depressive state of this disease. The possibility, however, that they~     are also involved in the manic phase of the disease was never addressed. The results of this~     study may have significant implications for the treatment of BD by DLC derivatives.~   "
171380|NCT01322100|"~     Because electrochemotherapy is a quick and effective treatment for cutaneous metastases, a~     novel electrode device has been developed for treatment in soft tissue such as the brain. Up~     to 18 patients will be treated in this phase I dose-escalating study of electrochemotherapy~     for brain metastases. Primary endpoint of the clinical trial is safety and secondary endpoint~     is efficacy. One brain metastasis is treated once-only with the electrode device guided~     stereotactically through a burr hole using CT monitoring. The patient will be fully~     anesthetized during the treatment procedure. Patients are followed up for 6 months with~     regard to neurological function, Barthel Index, steroid use and adverse effects registration~     (CTCAE). Tumor response will be evaluated by Magnetic Resonance imaging (MRI).~   "
171381|NCT01322087|"~     Rationale:~      The objective of this study was to investigate whether a new energy dense food concept, on~     order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at~     nutritional risk. The investigators target was for 70% of patients to reach 75% of their~     energy and protein requirements.~      Methods:~      An intervention study was conducted with inclusion of 40 patients at nutritional risk,~     according to the NRS-2002 criteria. The food concept consisted of 36 small delicious dishes.~     Patients could choose food from both the new concept and the ordinary patient buffet. The~     investigators monitored patients' nutritional requirements and daily nutritional intake.~   "
171382|NCT01322074|"~     In this study we evaluate if there is a correlation between acute pain and systemic~     inflammatory markers after total Knee Arthroplasty (TKA).~   "
171404|NCT01321788|"~     Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism~     (VTE). VTE remains the most common cause of maternal death in the developed world. It is up~     to 10 times more common in pregnant women than non-pregnant women of comparable age. More~     than a third of pregnancy-related VTE occurs during the six weeks after delivery. When~     compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy~     associated VTE by three-fold.~   "
171383|NCT01322061|"~     Opioids are the corner stone in the treatment of post operative pain. Because of the several~     side effects of opiods, non-steroidal anti-inflammatory drugs are usually added~     postoperatively to decrease the total requirements of opioids. However, non steroidal~     anti-inflammatory drugs have side effects of their own. Vitamin C, with virtually no side~     effects when used on short-term basis, has been shown to have promising analgesic effects in~     chronic pain and acute pain relief following orthopedic surgeries.~      The investigators propose to assess the role of a prophylactic single dose (2g) of vitamin C~     in reducing the intensity of pain and the consumption of opioids in patients undergoing~     laparoscopic cholecystectomy at AUB-MC.~      All eligible patients undergoing laparoscopic cholecystectomy at AUB-MC will be included in~     the study. Patients will be randomized into two groups to receive either single dose oral~     vitamin C (2g) (Study Group) or identically looking placebo capsules (Control Group). Both~     the patients and the investigation team will be blinded to the type of intervention.~     Intraoperative anesthesia management will be similar for both groups. Postoperative pain~     control will be achieved with patient controlled analgesia via a patient controlled morphine~     pump in both groups. At several time intervals and up to 24 hours postoperatively, the pain~     scores, morphine consumptions, nausea/vomiting scores, sedation scales, itching scales, and~     patient satisfaction scales will be obtained for all patients. Also, the peak vitamin C~     concentration will be determined for each patient.~      Patients demographics will be obtained and compared between both groups. The differences in~     pain scores, morphine consumptions, nausea/vomiting scores, and sedation, itching, and~     patient satisfaction scales will be compared between the two groups with the Student-t test,~     the analysis of variance, the Fisher exact test, and the Kruskal-Wallis test. The peak~     vitamin C plasma concentration will be correlated with the pain scores in each group using~     regression analysis.~      This study will provide relevant information on whether a single dose (2g) of vitamin C can~     reduce morphine requirements and non steroidal anti-inflammatory drugs need and thus~     eliminating their side effects in patients undergoing laparoscopic cholecystectomy.~   "
171384|NCT01322048|"~     The investigators intend to determine the effect of adrenergic blockade on 1) short-term~     physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe~     Traumatic Brain Injury (TBI).~      The primary hypothesis is that adrenergic blockade after severe TBI will be associated with~     increased ventilator-free days.~   "
171385|NCT01322035|"~     This study compares the improvement of weight, fasting lipid profile (triglycerides,~     cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in~     levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).~   "
171386|NCT01322022|"~     This study will compare the efficacy of a behavioral parent training program (PT) aimed~     specifically at common sleep disturbances compared to parent education (PE) program focusing~     on general issues related to autism. In a sample of 40 well characterized young children who~     meet criteria for an autism spectrum disorder (24-72 months), the investigators will test~     whether the five session PT program is superior to the PE program in decreasing sleep~     disturbances.~      The primary aim of this study is to evaluate the efficacy and feasibility of a PT program for~     sleep disturbance in young children with autism compared to PE.~      To this end, there are two hypothesis:~        -  Hypothesis 1: After the end of treatment, PT will be significantly more effective than~          PE in improving parent reports of a) bedtime struggles and resistance; b) sleep latency;~          c) night wakings; d) morning wakings; and / or e) sleep association problems as measured~          by the composite sleep index score from the modified Simonds and Parraga Sleep~          Questionnaire (MSPSQ; Simond & Parraga, 1982; Wiggs & Stores, 1998).~        -  Hypothesis 2: At the end of treatment, children in the PT group (n=20) will display~          significantly improved total sleep period as measured by actigraphy in comparison to~          children in the PE group (n=20).~      The secondary aim of this study is to evaluate the impact of participating in PT on child's~     daytime behavior and functioning and parenting stress compared to PE.~      To measure this aim, there are 4 exploratory hypothesis:~        -  Exploratory Hypothesis 1: Lower Irritability subscales scores will be reported on both~          parent and teacher / therapist completed Aberrant Behavior Checklist (ABC) for the PT~          group than the PE group at 4 weeks and 8 weeks~        -  Exploratory Hypothesis 2: Lower Child Behavior Checklist (CBCL; parent completed) and~          Caregiver-Teacher Report Form (C-TRF; teacher completed) scores will be reported for the~          PT group than the PE group at 4 weeks and 8 weeks.~        -  Exploratory Hypothesis 3: The PT group will have higher scores on the Vineland Adaptive~          Behavior Scales: 2nd Edition (VABS-II) at 4 weeks and 8 weeks compared to PE group.~        -  Exploratory Hypothesis 4: Parents receiving PT will report significantly lower scores on~          the Parenting Stress Index (PSI) at 4 weeks and 8 weeks compared to parents receiving~          PE.~   "
171387|NCT01322009|"~     The overall purpose of this research study is to investigate the safety of pharmacological~     therapies that may potentially improve pediatric outcomes after traumatic brain injury.~     Traumatic brain injuries are the leading cause of death and disability among children and~     young adults.~      Hypothesis: Combinational therapy with a membrane transporter and antioxidant are safe after~     TBI and can overcome barriers to the brain and synergistically improve bioavailability and~     efficacy the antioxidant content of the body and CNS after TBI.~   "
171388|NCT01321996|"~     The investigators aim to evaluate the role of 68Ga-DOTA-NOC PET/CT in patients with~     idiopathic pulmonary fibrosis, in particular in patients with a diagnosis of IPF/UIP~     (idiopathic pulmonary fibrosis, diagnosed based in the American Thoracic Society and European~     Respiratory Society criteria) and in forms of NSIP (non-specific interstitial pneumonia).~     PET/CT imaging data will be compared with HRCT (high-resolution computed tomography) findings~     to assess disease extension, early disease detection and to non-invasively detect~     somatostatin receptors expression at lung level in these patients, with potential therapeutic~     implications.~   "
171389|NCT01321983|"~     OBJECTIVE: to determine whether preoperative inspiratory muscle training (IMT) is able to~     attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung~     volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery.~      Therefore, the hypothesis of the present study was that preoperative IMT is able to attenuate~     the negative effects of surgical trauma on the respiratory muscle strength, in the lung~     volumes and diaphragmatic excursion, thus reducing the risk of PPC, in obese patients~     undergoing open bariatric surgery.~      DESIGN: Randomized controlled trial. SETTING: Meridional Hospital, Cariacica/ES, Brazil.~     SUBJECTS: Thirty-two obese women undergoing elective open bariatric surgery were randomly~     assigned to receive preoperative inspiratory muscle training (IMT group) or usual care~     (control group).~      MAIN MEASURES: Respiratory muscle strength (maximal inspiratory pressure - MIP and maximal~     expiratory pressure - MEP), lung volumes and diaphragmatic excursion.~   "
171390|NCT01321970|"~     Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis~     that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in~     patients with known coronary chest pain.~   "
171391|NCT01321957|"~     The primary objective of this study is to evaluate the efficacy of Irinotecan in combination~     with FOLFOX+Bevacizumab versus FOLFOX+Bevacizumab alone in the first-line treatment of~     patients with metastatic colorectal cancer.~   "
171405|NCT01321775|"~     The purpose of this study is to determine the efficacy of the combined therapy Bevacizumab,~     trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+~     followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin~     liposomal).~   "
171422|NCT01321554|"~     This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare~     the progression free survival of participants with 131 I -refractory DTC and radiographic~     evidence of disease progression within the prior 12 months, treated with lenvatinib 24 mg by~     continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a~     Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind~     treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment~     Period and a follow-up period).~   "
171423|NCT01321541|"~     The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to~     Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma~     (DLBCL), or follicular grade 3 lymphoma.~   "
171392|NCT01321944|"~     Tobacco use is the leading preventable cause of death in the United States. Effective~     treatment for tobacco dependence exists and includes counseling and pharmacotherapy with~     nicotine replacement, bupropion, or varenicline. The health care system is a key channel for~     delivering this treatment to smokers. Brief clinical interventions delivered at office visits~     increase smoking cessation rates, are among the most cost-effective of medical interventions,~     and are recommended by U.S. Public Health Service. However, physicians and other clinicians~     often fail to provide them. Clinicians' rates of providing tobacco treatment in ambulatory~     care can be improved, but even when successful, clinicians can only reach smokers who make an~     office visit.~      A health care system might improve its delivery of tobacco treatment by supplementing~     visit-based efforts with a population-based strategy, using methods proven effective in~     public health settings. A population of smokers could be identified from electronic health~     records and offered treatment proactively in a way that maximizes convenience and minimizes~     barriers such the cost of pharmacotherapy. This study tests the effectiveness of a~     population-based Direct-to-Smoker (DTS) outreach program provided to smokers in one community~     health center in Revere, MA, that is part of an integrated health care system. It uses the~     system's population management tools to identify smokers and proactively offers them~     evidence-based tobacco treatment that is free and does require making an office visit. A~     randomized controlled trial will compare the effectiveness of the DTS program to usual~     primary care. The hypothesis is that adding the DTS program to usual primary care will~     increase the proportion of smokers who use tobacco dependence treatment and thereby stop~     smoking.~   "
171393|NCT01321931|"~     Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A~     study in healthy smokers.~   "
171394|NCT01321918|"~     The main objective of this study is the formation of a DNA bank to realise a case-control~     genetic study designed to identify sequence variations in DNA that predispose to sudden~     cardiac death in adults.~      The secondary objective of this study is the creation of a register for epidemiological~     surveillance of adult extra-hospital sudden death.~   "
171395|NCT01321905|"~     The vast majority of Cystic Fibrosis (CF) patients worldwide are vitamin D insufficient.~     There is no evidence of benefit of vitamin D supplementation for CF patients yet. However,~     descriptive cross-sectional studies suggest that vitamin D might be beneficial with respect~     to bone health, as well as to the newly described non-classical functions of vitamin D such~     as the potential anti-diabetic and immunomodulatory effects. To prove causation, and to~     determine which serum vitamin D concentration is optimal for CF patients, vitamin D~     supplementation interventional studies are needed, such as our trial.~   "
171396|NCT01321892|"~     The purpose of this research study is to collect information on whether images made using~     investigational microscopes can improve researchers' ability to evaluate and distinguish~     between normal and abnormal areas in tissue samples surgically removed from patients with~     squamous cell carcinoma. The microscopes being used in this study are considered~     investigational because they have not been approved by the United States Food and Drug~     Administration (FDA) for finding abnormal or pre-cancerous areas.~   "
171397|NCT01321879|"~     The goal of this clinical research study is to learn if Vibativ (telavancin) can help to~     control blood stream infections (BSIs). The safety of this treatment will also be studied.~      Objectives:~      Evaluate the clinical efficacy and safety of Telavancin given for treatment of gram positive~     bacteremia in cancer patients (including neutropenics).~   "
171398|NCT01321866|"~     The main objective of this study is to evaluate and compare the primary patency rate at 12~     months in a group of hemodialysis patients operated on by cutting balloon and in a group of~     hemodialysis patients operated by conventional balloon.~   "
171399|NCT01321853|"~     The purpose of this study is to determine whether a home care medication management program~     which includes nurse coordination and use of the MD.2 medication-dispensing machine will~     affect older adults' health outcomes, satisfaction, use of health care services, and health~     care costs over a one year period. The investigators propose a longitudinal three group~     repeated measures design, enrolling, and randomly assigning, clients who are discharged from~     a home health care agency with documented problems in medication management. One group will~     receive the MD.2 medication dispensing device and nurse coordination, the second group will~     receive a Medplanner: a simple box that has separate compartments for individual medication~     times over the course of a week plus nurse coordination, and the final group will receive~     Usual Care.~      The study hypotheses are the following:~      H1: With respect to health status outcomes, the MD.2 group will exhibit a more positive~     trajectory in physical and mental health status, functional status, cognitive status and~     depressive symptoms over the course of a year than will the Medplanner Group.~      H2: With respect to health status outcomes, the Medplanner Group will exhibit a more positive~     trajectory in physical and mental health status, functional status, cognitive status and~     depressive symptoms over the course of a year than will the Usual Care Group.~      H3: The rate of hospitalization, hospital days and emergency department visits will be~     significantly lower for the MD.2 Group as compared to the Medplanner Group.~      H4: The rate of hospitalization, hospital days and emergency department visits will be~     significantly lower for the Medplanner Group as compared to the Usual Care Group.~      H5: The nursing home admission rate will be significantly lower for the MD.2 Group as~     compared to the Medplanner Group.~      H6: The nursing home admission rate will be significantly lower for the Medplanner Group as~     compared to the Usual Care Group.~      H7: The total cost of care will be significantly lower for the MD.2 Group as compared to the~     Medplanner Group.~      H8: The total cost of care will be significantly lower for the Medplanner Group as compared~     to The Usual Care Group.~      H9: There will be incremental savings in terms of costs per quality adjusted life year (QALY)~     gained in the MD.2 group compared with the Medplanner Group.~      H10: There will be incremental savings in terms of costs per QALY gained in the Medplanner~     group compared with the Usual Care Group.~   "
171400|NCT01321840|"~     The aim of the study is to test, if patients suffering from Endometriosis show changes in~     their brain function, when being treated with SART (Systemic Autoregulation Therapy), a~     complex intervention consisting of interventions from Traditional Chinese Medicine (TCM) and~     Western Hypnotherapy. Functional and structural brain changes are assessed using Magnetic~     Resonance Imaging data which are analyzed by means of voxel-based morphometry (VBM),~     connectivity and perfusion analysis. A third outcome measure are changes of patients' heart~     rate variability, indicating the activity of their autonomic nervous system.~      With a number of questionnaires, changes in dysmenorrhea, chronic pelvic pain, menstruation~     regularity, dyspareunia, defecation pain, and quality of life are assessed during the SART~     treatment.~      During the treatment, we expect to see changes in cortical thickness, functional connectivity~     and perfusion of pain-related areas of the cortex, that correlate with the changes in heart~     rate variability.~   "
171401|NCT01321827|"~     The purpose of this study is to evaluate the efficacy and safety of itraconazole monotherapy~     in patients with ABPA.~   "
171402|NCT01321814|"~     The main purpose of this study is to investigate whether cognitive behaviour therapy (CBT)~     can be useful for people suffering from Hyperacusis.~      Also, the investigators are interested in investigating this group of patients on psychiatric~     and somatic comorbidity, personality traits, and startle response to sounds.~      The investigators will also study the audiological measures commonly used in Sweden to~     measure hyperacusis, and investigate their validity.~      The investigators hypothesize that CBT might be helpful for patients suffering from~     Hyperacusis.~   "
171403|NCT01321801|"~     The purpose of this study is to evaluate how effective is the preoperative administration of~     pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic~     cholecystectomy.~   "
171406|NCT01321762|"~     Pelvic organ prolapse (POP) is one of the most common indications for gynaecological surgery.~     In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in USA (22.7~     per 10000 women) at an estimated cost of more than one billion dollars. In the UK, the~     disorder accounts for 20% of the women on the waiting list for major gynaecological surgery.~     Vaginal birth, advancing age and increasing body mass are the most consistent risk factors.~     Furthermore a racial and congenital predisposition has been reported. The cause of this~     disorder is likely to be multifactorial and attributable to a combination of factors, varying~     from patient to patient.~      Controversy exists as to whether the pregnancy per se rather than the mode of delivery alters~     the risk of POP. Caesarean section appears to protect against the development of prolapse.~     However, when a caesarean section is undertaken during the active stage of labour it may not~     be completely protective. Ideally prospective longitudinal studies are needed to study the~     impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately, studies to date,~     are small with poor follow-up and have only assessed objective outcome rendering it difficult~     to draw conclusions. The primary objective of our study was to objectively assess the impact~     of pregnancy and childbirth on pelvic organ support using the Pelvic Organ Prolapse~     Quantification (POPQ)System.~   "
171407|NCT01321749|"~     This study is a prospective, randomized, single-center trial, designed to observe the effect~     of remote limb ischemic preconditioning on ischemic cerebral vascular disease.~   "
171408|NCT01321736|"~     Dietary fiber is known to influence bowel function. The investigators hypothesize that the~     addition of a mixture of fibers to liquid diets will improve bowel function as measured by~     stool weight.~   "
171409|NCT01321723|"~     This study is designed to provide information about the bone anabolic properties and~     absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of~     24 weeks to postmenopausal women with osteoporosis.~   "
171410|NCT01321710|"~     The purpose of this study is to test a behavioral intervention to minimize sleep disruption~     and fatigue in new mothers after the birth of their first infant. This study also tests~     whether an acetaminophen intervention at the time of an infant's 2-month immunization series~     improves infant and maternal sleep.~   "
171411|NCT01321697|"~     This will be a non-blinded, non-randomized study to further our knowledge of and experience~     with lymph node surgery. The investigators are interested in documenting and reporting the~     variations in leg lymphatic drainage sentinel lymph node biopsy (SLNB) with inguinal-femoral~     lymph node dissection (IFLND). The study will be open at the Winthrop P. Rockefeller Cancer~     Institute at The University of Arkansas for Medical Sciences (UAMS). Dr. Pamela Stone,~     Dr.Alexander Burnett, and Dr. Juan Roman will be responsible for accruing subjects to this~     study. It will be open to all patients presenting to the Winthrop P. Rockefeller Cancer~     Institute with vulvar cancer requiring lymph node evaluation for the ipsilateral and/or~     contralateral groin who have not had prior groin surgery or radiation to the groins. Patients~     must meet inclusion and exclusion criteria to be enrolled.~   "
171412|NCT01321684|"~     For unilateral spinal block, spinal local anesthetics should take effect on the spinal nerves~     of one side. With full flexion of the spine, the cauda equina becomes tightened and hangs in~     the middle of the subarachnoid space. This study was performed to assess if flexion of the~     vertebral column facilitates unilateral spinal anesthesia.~   "
171413|NCT01321671|"~     The purpose of this study is to evaluate the pharmacokinetics of a single dose of a~     pregabalin controlled release (CR) tablet administered fasted in the evening relative to a~     single dose of the CR tablet administered immediately following a 600 to 750 calorie evening~     meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will~     also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR)~     capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.~   "
171414|NCT01321658|"~     This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal~     cancer. The patients will be randomized into two groups. The control group will receive~     standard surgical treatment. The intervention group will in addition go through a~     preoperative comprehensive geriatric assessment. The assessment will include evaluation of~     co-morbidity and medication, social status, nutritional status, cognition, depression and~     physical performance. This assessment will form basis of an individualized perioperative~     intervention.~      The main aim of the study is to see if the number of postoperative complications in this~     group can be reduced by a perioperative geriatric intervention. A study of inflammation~     markers in serum will also be performed, with focus on identifying potential biological~     frailty markers.~   "
171415|NCT01321645|"~     Acne is one of the most common skin problems in teenagers and adolescents. There are many~     lesser known homoeopathic medicines which have been mentioned in the literature for treatment~     of acne but their potential has not been properly assessed /documented and therefore these~     medicines don't form a part of many prescriptions. As a part of this study,efficacy of~     Azadirachta Indica will be studied in the treatment of Acne vulgaris~   "
171416|NCT01321632|"~     Acne is one of the most common skin problems in teenagers and adolescents. There are many~     lesser known homoeopathic medicines which have been mentioned in the literature for treatment~     of acne but their potential has not been properly assessed /documented and therefore these~     medicines don't form a part of many prescriptions. As a part of this study, efficacy of~     Zingiber officinalis will be studied in the treatment of Acne vulgaris~   "
171417|NCT01321619|"~     The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared~     to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal~     syndrome.~   "
171418|NCT01321606|"~     The investigators have two hypotheses: (1) The probiotic L. rhamnosus HN001, when compared to~     placebo, will reduce S. aureus nasal colonization when taken for four weeks. (2) The~     probiotic L. rhamnosus HN001, when compared to placebo, will reduce S. aureus~     gastrointestinal colonization when taken for four weeks.~   "
171419|NCT01321593|"~     The purpose of this study is to compare the hemoglobin results obtained with the Orsense~     NBM-200MP device and the Clinical Laboratory.~   "
171420|NCT01321580|"~     The purpose of this study is to compare the hemoglobin results obtained with the Masimo~     Pronto 7 and the Clinical Laboratory.~   "
171421|NCT01321567|"~     To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton~     Pump Inhibitor-resistant reflux esophagitis~   "
171424|NCT01321528|"~     The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie~     (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry~     of their thoughts and beliefs connected to stressful circumstances or symptoms. This~     meditative process, named The Work, enables the participants to identify and question the~     stressful thoughts that cause their suffering. The core of IBSR is simply four questions and~     a turnaround, which is a way of experiencing the opposite of what the participant believes.~     This process is simple, powerful and can be easily implemented in daily life.~      Therefore, on the basis of previous data and beneficial observations the investigators~     postulate that the clinical utility of IBSR mediation program may alleviate stress and rate~     of burnout and improve quality of life among health care professionals. Thus, we will conduct~     a pilot/feasibility Observational study designed to:~        -  Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and~          program satisfaction.~        -  investigate whether IBSR intervention is efficacious in alleviating stress and rate of~          burnout and improving quality of life among health care professionals.~   "
171425|NCT01321515|"~     The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets~     under fasting conditions.~   "
171426|NCT01321502|"~     The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets~     under fed conditions.~   "
171427|NCT01321489|"~     The purpose of this study is to evaluate the tolerability and safety of Sildenafil Citrate~     20mg Sublingual tablet, as well as a possible superiority expressed by the faster onset of~     action compared to Viagra ® 50mg tablet Coated in erectile dysfunction.~   "
171428|NCT01321476|"~     This study will use excess tissue from endoscopic or surgical procedures to examine the~     elements of plaque that are found in the carotid walls of patients who have a type of heart~     and blood vessel disease called atherosclerosis. Tissue will be collected from patients~     undergoing carotid procedures as well as patients undergoing liver and/or intestinal~     biopsies. This lab study will examine the different types of proteins that play a role in~     developing heart plaque.~   "
171429|NCT01321463|"~     PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is~     associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential~     safety and efficacy profile in COPD.~   "
171430|NCT01321450|"~     Including 150 randomised patient, the studies aim is to determine whether an economisation~     and/or improvement in terms of operating time, drainage fluid, blood loss, time of~     hospitalisation can be found using an ultrasonic dissection device versus traditional~     surgical methods such as stitches an ligations.The study is performed for patients undergoing~     partial pancreatoduodenectomy.~   "
171431|NCT01321437|"~     The purpose of this research study is to determine the efficacy of Axitinib in treating~     individuals with Stage III melanoma.~   "
171432|NCT01321424|"~     The purpose of this study is to measure the change in Tear Osmolarity during the course of~     the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and~     differentiate between the two forms of dry eye.~   "
171433|NCT01321411|"~     Respiratory muscles (the muscles used to breathe) need more blood (and oxygen) when their~     workload increases. It is difficult to measure respiratory muscle blood flow (RMBF) without~     invasive techniques. We will evaluate a new, much less invasive technique to measure RMBF in~     2 groups: Healthy Volunteers and Critically Ill patients on breathing machines. The purpose~     of this study is to determine the accuracy of this new monitoring technique called Near~     Infrared Spectroscopy Utilizing Indocyanine Green Dye when compared with traditional~     measurements. The information gained from this study will help us to provide better care to~     patients with severe lung problems.~   "
171434|NCT01321398|"~     Patients with severe lung conditions occasionally require support with a special ventilator~     (breathing machine) called the High Frequency Oscillator (HFO). Effective ventilation~     requires that the pressure generated by the ventilator be as high as possible but not too~     high as this can damage the lungs. In patients on HFO, there is not a well defined way to~     measure this pressure. We will insert a small probe into the esophagus of patients on HFO to~     see if this is an accurate way to measure lung pressures for these patients. A better~     understanding of these pressures could lead to improved patient care.~   "
171435|NCT01321385|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors predict how well patients will respond to treatment.~      PURPOSE: This research trial is studying biomarkers in predicting response to treatment in~     bone marrow samples from young patients with acute myeloid leukemia.~   "
171436|NCT01321372|"~     Hematology patients are at high risk for invasive fungal infection (IFI) and are being~     treated with voriconazole (VOR) at Princess Margaret Hospital (PMH). It is critical that~     patients' serum drug levels are within therapeutic ranges when undergoing treatment. The~     primary objective of this study is to determine whether clinical responses~     (complete/partial/failure) directly correlate with patients' blood VOR drug levels.~      In patients whose disease progression is associated with inadequate voriconazole (VOR) drug~     levels, serum drug level determination can allow for dose adjustment, thereby preventing~     disease progression. Patients who are extensive metabolizers may have subtherapeutic VOR~     levels leading to treatment failure whereas, poor metabolizers may have high drug levels that~     cause toxicity. Isoenzyme such as CYP2C19 exhibits genetic polymorphism. Genotyping tests can~     also be helpful in determining patient risk subjecting to extreme spectrum of drug levels.~   "
171437|NCT01321359|"~     Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis~     (RHL).~   "
171453|NCT01321151|"~     Sports-related concussions are a serious problem in football, boxing, and other full contact~     sports. After experiencing consecutive concussions, there is an increase in neurological~     deficits that can lead to long-term cognitive problems (Dementia pugilistica). To combat this~     increase in brain damage, novel strategies need to be developed to protect athletes that are~     participating in these full contact sports. The purpose of this study is to elucidate whether~     resveratrol decreases brain injury and improves brain function after experiencing a~     concussion in boxers.~   "
172050|NCT01313273|"~     The aim of the study is to compare in an exploratory fashion the efficacy on progression-free~     survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non~     metastatic castrate resistant prostate cancer patients.~   "
171438|NCT01321346|"~     This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL),~     Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL).~     Panobinostat is a new drug that is considered investigational because it has not been~     approved in the United States by the Food and Drug Administration (FDA), or in any other~     country. Panobinostat is a histone deacetylase inhibitor (HDACi) and interferes with gene~     expression found in cells causing them to stop growing or die. Panobinostat has been used in~     several hundred adults who had leukemia, HD, NHL and other solid tumors. Panobinostat has not~     been given to children.~      This is a phase I study. In a phase I study, drugs are tested to the highest dose that can be~     safely given. Drugs are given at gradually increasing dosages until there are unacceptable~     side effects. The goal of the Phase I study is to find out the dose of panobinostat that can~     be safely given to children with relapsed ALL, AML, HD and NHL.~   "
171439|NCT01321333|"~     This study will evaluate the effect of single transplantation of HuCNS-SC cells into the~     thoracic spinal cord of patients with sub-acute spinal cord injury.~   "
171440|NCT01321320|"~     The primary hypothesis for this study is that Myostatin and FHL-1 are important in the~     development of ICUAP and that changes in activity levels of muscle will modify the levels of~     expression and activity of these proteins.~   "
171441|NCT01321307|"~     Sorend is a water-based formula, which contains carob, melissa and sage. Elder inhabitants of~     Israel are known to use carob extract to ease sores in the mouth, due to the tannins which~     create a complex with various proteins and polysaccharides, thus creating an impenetrable~     layer covering the sores, allowing spontaneous healing.~   "
171442|NCT01321294|"~     The aim of this study is to compare subjective and objective outcome and surgical side~     effects of Nissen and Toupet fundoplication performed in a single institution by only two~     surgeons and to compare pre and postoperative findings to healthy individuals.~   "
171443|NCT01321281|"~     Osteoarthritis (OA) is the most common kind of arthritis and primarily affects the large,~     weight bearing joints (including the knees, lower back, hips, neck and the feet) and the~     joints in the hands. OA results from the breakdown of cartilage in joints, leading to joint~     pain and damage. It affects about 8 million people in the United Kingdom and nearly 27~     million people in the United States, most of whom are over the age of 45.~      This study aim to determine if Aquamin (as AquaCal and AquaPT) affects molecules of~     inflammation in the blood of osteoarthritis and healthy subjects.~   "
171444|NCT01321268|"~     To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat~     deposits and quality of life.~   "
171445|NCT01321255|"~     The aim of the FOCUS project is to test the Fixed Dose Combination concept for cardiovascular~     prevention in populations of different socio-economic characteristics. At the same time,~     FOCUS aims to understand the factors determining inappropriate prescribing for secondary~     cardiovascular prevention and those for poor patients adherence to treatment. This will allow~     FOCUS to establish recommendations for a better use of medication in patients with ischemic~     heart disease. In addition, after a successful completion of FOCUS, secondary prevention~     medication will be available and affordable for a large number of patients in both developed~     as well as developing countries.~      There are two Phases in this study:~      Phase 1: Is a descriptive, non interventional study. Phase 2: Is an interventional,~     randomized trial with prospective economic evaluation.~   "
171446|NCT01321242|"~     This is a multicenter survey of Russian data on target heart rate achievement in patients~     with stable angina and arterial hypertension who are currently treated with beta-blockers for~     at least 2 months and with no dose change for a minimum of 4 weeks~   "
171447|NCT01321229|"~     The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after~     stroke. The association of the sleep respiratory troubles with a reserved functional~     prognosis is debated. The purpose is to find out the frequency of the sleep respiratory~     troubles after stroke in a PRM department and to study their relationship with functional and~     neurological recovery.~   "
171448|NCT01321216|"~     This study aims to determine the contribution of rotavirus infection as a cause of~     gastroenteritis requiring hospitalization in children younger than 5 years of age.~     Additionally, a secondary aim will be to determine the genotypes of rotavirus that cause~     these infections as prevalent in Lebanon.~   "
171449|NCT01321203|"~     To assess the safety and efficacy of CO2 insufflations during ERCP~        1. Primary objective:~           To assess the patient's symptoms, abdominal pain and abdominal distension post procedure~          (ERCP) in the study group.~        2. Secondary objective:~      Endoscopist:~        -  To assess the adequacy of bowel distension for adequate luminal visualization~        -  To assess the peristaltic movement during the ERCP~      Anesthetist:~        -  To measure the PCO2 level in patient post procedure.~        -  To assess the amount of sedation required during the procedure.~        -  To assess saturation and vital signs through out the procedure.~        -  To assess requirement of buscopan.~   "
171450|NCT01321190|"~     One way to better understand how various treatments for pain differ is to determine the~     effects of these treatments on different pain qualities or characteristics. For example, pain~     can be described as hot, electrical, cold, achy, and piercing. In order to~     determine which pain quality/qualities that a pain treatment affects, researchers must~     develop measures of these pain qualities or characteristics. The purpose of this study is to~     learn more about the different pain qualities individuals who have low back pain, headaches~     and fibromyalgia experience. Identifying the common qualities of pain experienced by these~     groups will help researchers evaluate and develop more comprehensive pain quality measures,~     which will ultimately help them to be able to test the effectiveness of treatments for these~     different pain qualities.~   "
171451|NCT01321177|"~     The purpose of this study is to determine how services should be provided to reduce symptoms~     and improve life functioning for adolescents and adults who have been recently diagnosed with~     schizophrenia.~   "
171452|NCT01321164|"~     The main objective of the study is to evaluate the additional effect of a narrow band Type B~     Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid~     esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the~     effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach~     Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate~     whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a~     positive predictive factor for the treatment response.~   "
171454|NCT01321138|"~     Femoral neuropathy after anterior cruciate ligament reconstruction with femoral nerve block~     may be as high as 24% at 6 postoperative weeks when evaluated prospectively and~     systematically through a clinical neurological and an electroneuromyography (ENMG). It is~     still unclear whether this neuropathy is the result of the surgery, especially the~     Tourniquet, or the block nerve. The goal of this study is to define the etiology of this~     postoperative neuropathy.~   "
171455|NCT01321125|"~     The physicians have few options for skin antisepsis. Alternatives for common use antiseptics~     are costly or ineffective. In order to have more options, this study is needed. The~     investigators want to know if there are differences between the use of 2% chlorhexidine~     gluconate in 70% isopropyl alcohol or 10% sodium hypochlorite.~   "
171456|NCT01321112|"~     As is well known, immunosuppressive treatment (IS) after liver transplantation has several~     and frequents adverse effects that limit the survival of the graft and recipients. Because of~     that, it is desirable that these recipients were able to receive a mild IS regime with a~     better safety profile. An attempt to get that aim has been evaluated in several trials in the~     past, and consist in to change the IS regime from an calcineurin inhibitors (CNI) based to~     another less intense and with less adverse effects based on mycophenolate mofetil (MMF),~     which is known to have a better safety profile. The success rate of this strategy(i.e.~     complete conversion in absence of rejection) has a wide range from 100% to 50% approximately.~     However it is accepted that this strategy is associated with the improvement of several~     adverse effects of CNIs such as renal failure and dyslipemia. This study's aim is to perform~     IS conversion from CNI to MMF monotherapy and look for transcriptional biomarkers employing a~     whole genome expression study performed with microarrays at baseline on liver tissue and/or~     PBMCs to try to find a differential gene expression able to correlate with a successful~     conversion and thus, to generate a set of transcriptional biomarkers potentially able to~     predict the result of the IS conversion on an independent cohort of liver recipients.~   "
171457|NCT01321099|"~     Iron deficiency (ID) is still a main public health problem in sub-Saharan Africa. Iron~     deficient children have an increased risk for anemia which is associated with adverse infant~     development that might be partly irreversible. In sub-Saharan Africa, the etiology of ID in~     children is multifactoral; but the major causes are low iron dietary bioavailability and~     intake from monotonous cereal-based complementary foods. Children < 5 years old can benefit~     from iron-fortified complementary foods; however, these fortified complementary foods are~     often not adapted to the requirements of children in specific setting. The investigators~     developed a complementary food fortificant (CFF) which is added to local porridge and is~     deemed to meet the nutrient intake requirement for iron in children 1-3 years of age. The CFF~     is lipid-based and can therefore, if regularly used, increase the daily energy intake of~     children which is often too low in developing countries with cereal-based diets.~      The iron absorption from the mixture of CFF and porridge has to be optimized because it~     contains quite a high amount of phytate, a well-known inhibitor of iron absorption. To~     optimize iron absorption the investigators are planning three iron absorption studies using~     different compounds of iron (FeSO4 + NaFeEDTA), additional vitamin C and phytase, which is~     able to degrade phytate. In the first study, iron absorption will be determined from a~     mixture of CFF and porridge fortified with 1) 6 mg FeSO4 and 2) 6 mg FeSO4 plus additional~     vitamin C. In the second study, the test meals will be fortified with 1) 6 mg FeSO4 and 2) a~     mixture of 3 mg FeSO4 + 3 mg NaFeEDTA. In the third study, test meals will be fortified with~     1) 6 mg FeSO4, 2) 6 mg FeSO4 plus phytase, and 3) 6 mg FeSO4 plus additional vitamin C and~     phytase. Iron absorption will be determined by incorporation of labeled iron into~     erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable~     isotope technique). Sixty apparently healthy Beninese children 12-36 months of age with a~     body weight > 8.3 kg will be included in the study. Additionally, the investigators will test~     acceptability of CFFs based on different composition formulas by interviewing the~     parents/legal guardians of the children after feeding the CFF for a defined period.~      The results of these studies will provide important insights to optimize the iron absorption~     of young children from a CFF mixed with local traditional porridge in developing countries.~     Furthermore the studies will provide information on the acceptability of CFFs in such a~     setting.~   "
171458|NCT01321086|"~     The investigators are conducting a clinical research trial to determine the role of~     motivational interviewing (MI) on promoting home-based walking therapy to improve walking~     ability in African Americans with peripheral arterial disease (PAD). African Americans are~     more than two times as likely as non-Hispanic whites to suffer from PAD. For patients with~     PAD, there is a significant risk for poor walking ability and limb loss. One major treatment~     for PAD is walking therapy but the traditional methods for the delivery of this treatment~     have required frequent visits to a university or hospital-based site. The investigators will~     address the role of self-managed walking program, to be conducted at or near the home, to~     improve limb function. In order to motivate the participants to walk, the investigators~     included two different intervention strategies: MI and patient-centered counseling for~     exercise (PACE). The investigators hypothesize that participants randomized to the MI arm~     will have a greater increase in their walking distance, compared to those receiving~     Patient-Centered Assessment and Counseling for Exercise (PACE) and the control group.~   "
171459|NCT01321073|"~     The purpose of the DelIVery for PAH clinical study is to evaluate the safety of the Medtronic~     Model 10642 Implantable Intravascular Catheter when used with the Medtronic SynchroMed® II~     Implantable Infusion System to deliver Remodulin® (treprostinil) Injection.~   "
171460|NCT01321060|"~     Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the~     treatment for this is controversial. In this study, the investigators aim to evaluate the~     different effects of three different treatment protocols which is repeated aspiration,~     continuous catheter drainage and conservative treatment. The investigators suppose repeated~     aspiration could not only solve acute fluid collections, but also lower the rate of~     pancreatic infection.~   "
171461|NCT01321047|"~     Based on previous results, the investigators considered that sedation quality, complications,~     and procedure outcomes may not be different, however, propofol alone titration may have a~     fast recovery time than BPS and cost-effectiveness than balanced propofol sedation (BPS). In~     present study, the investigators therefore evaluate the time and sedation quality of patient~     recovery, cost-effectiveness, complication, and procedure outcomes between propofol alone and~     BPS in therapeutic endoscopic retrograde cholangiopancreatography (ERCP).~   "
171462|NCT01321034|"~     Objectives.~        -  To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg~          day of Niacin/Laropiprant in subjects with normal Lp(a) (< 30 mg/dL), high Lp(a) (30-60~          mg/dL) and very high Lp(a) (> 60 mg/dL).~        -  To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg~          day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on the~          apo(a) gene. 2.1.1 Hypotheses.~        -  The Lp(a) lowering effect of niacin is dependent of the pre-treatment Lp(a)~          concentration, with higher absolute and relative reduction in Lp(a) in subjects with~          hyperlipoproteinemia(a).~        -  Lp(a) size, throughout modifying hepatic synthesis of apo(a), is a major factor related~          to the lowering effect variability of niacin in human.~   "
171463|NCT01321021|"~     This project aims at identifying novel pharmacological targets for the treatment of memory~     disorders.~   "
171465|NCT01320995|"~     The main objective of this study is to compare the rate of anal incontinence (measured by the~     Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas~     with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by~     conducting a sphincter ultrasound in the delivery room versus a similar group of women who do~     not benefit from screening.~   "
171466|NCT01320982|"~     The objective of the study is to evaluate the efficacy of Pramipexole, Minocycline and~     Aspirin compared to placebo, as add-on to anti-psychotics in the treatment of patients with~     schizophrenia.~   "
171467|NCT01320969|"~     It is well-established that the practice of mindfulness meditation leads to improvements in~     mental health and well-being and the cultivation of positive emotions. However, the neural~     mechanisms of these improvements are largely unknown. A few recent studies suggest that~     mindfulness meditation impacts the structure and function of the ventromedial prefrontal~     cortex, the hippocampus, and the amygdala. Interestingly, recent studies have shown that~     these regions are part of a brain circuit that is critical for the extinction of conditioned~     fear responses, and for the retention of fear extinction memory. Building on the overlap of~     these regions and on conceptual considerations, the project investigates whether mindfulness~     meditation could influence one's capacity to retain the memory of fear extinction.~     Meditation-naïve participants will be randomized to either a mindfulness-meditation based~     training or an active control training that controls for all mindfulness-unspecific~     components. Participants will undergo a fear conditioning, extinction and extinction recall~     protocol in an MRI scanner before and after the trainings. We hypothesize that participants~     who have practiced mindfulness meditation will show greater improvements in fear extinction~     memory after the course, and that these improvements will be correlated with anatomical and~     functional changes in the brain regions of interest. Improvements in fear extinction memory~     will also be related to improvements in self-reported psychological well-being. Merging the~     fields of an ancient spiritual tradition and a fundamental learning mechanism, the project~     investigates the underlying neural mechanisms of a practice for the enhancement of mental~     health and well-being.~   "
171468|NCT01320956|"~     This study aims to find how hypnosis performed just before a painful surgery can change~     anxiety level, in children aged 10 to 18 years.~   "
171469|NCT01320943|"~     The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss~     and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF~     arm) compared to participants who continue TDF (Continue TDF arm).~      Only participants who already are on treatment with TDF monotherapy or TDF in combination~     with lamivudine or emtricitabine for at least 4 years and who achieved and maintained~     virologic suppression (< 400 copies/mL) for 3.5 or more years will be included in this study.~     One treatment arm will stop the TDF therapy while the other treatment arm will continue the~     TDF therapy. Participants in the Stop TDF arm will be monitored very closely with special~     focus on biochemical flares (especially alanine aminotransferase (ALT) increases) and~     virological relapses (Hepatitis B viral load increases). If any participant in the Stop TDF~     arm exceeds one or more predefined limits for such flares or relapses, TDF treatment will be~     reinstituted.~   "
171470|NCT01320930|"~     The study is a single-center randomized, unblinded, placebo-controlled study to investigate~     the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive~     pulmonary disease (COPD).~   "
171471|NCT01320917|"~     Obesity is a disorder associated with metabolic dysfunction and changes in cardiovascular~     risk markers; the use of oral contraceptives (OCs) may exert a further negative effect on~     these alterations in patients with PCOS.~      To assess the effects on arterial function and structure and hemostatic parameters using an~     levonorgestrel intrauterine device (IUS-LNG) in women with obesity~      A randomized controlled clinical trial.~   "
171472|NCT01320904|"~     Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES)~     combined with closed kinetic chain (CKC) exercises in patients with knee OA.~   "
171473|NCT01320891|"~     Aim of the study is to ascertain whether a different strategy of fluids administration can be~     responsible of differences in terms of acid/base disorders (Stewart approach),~     pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated~     either with not-balanced solutions (Normal Saline) or balanced solutions~   "
171474|NCT01320878|"~     The objective of this study was to assess the efficacy and appropriate dose of iloprost for~     inhalation in the treatment of postoperative pulmonary hypertension in children with~     congenital heart defects.~   "
171475|NCT01320865|"~     The investigators hypothesize that bone marrow progenitor cells are mobilized into the~     circulation in PAH, home to the lungs and differentiate into mast cells, which promote~     vascular remodeling and vasoconstriction through release of renin and chymase. As a corollary~     to this, the investigators hypothesize that anti cKit tyrosine kinase inhibitor (TKI),~     nilotinib, provides clinical benefit to patients through inhibition of mast cell progenitor~     proliferation, mobilization and differentiation. To test this, the investigators will~     determine if mast cell progenitors and mast cell biomarkers are related to nilotinib clinical~     response. This will be an ancillary study, part of a placebo-controlled, double-blind multi~     center clinical trial of nilotinib in pulmonary arterial hypertension.~   "
171476|NCT01320852|"~     This study aims at testing the utility of PET Scan as a screening tool for liver~     transplantation in patients with Hepatocellular Carcinoma. Patients being worked up for liver~     transplant for hepatocellular carcinoma will undergo a PET Scan and will be followed until 2~     years after transplantation. At that time survival data will be analysed according to PET~     Scan results to determine if it can be used to predict outcome.~   "
171477|NCT01320839|"~     We hypothesize that: (1) gait stability will be increased when wearing an ankle-foot orthosis~     (plastic brace supporting the foot and ankle); (2) an attention demanding task will decrease~     gait stability and (3) the improvement in gait stability due to ankle-foot orthosis use will~     be greater during an attention demanding task.~   "
171478|NCT01320826|"~     It is hypothesized that primary care colonoscopists are able to achieve benchmarks in~     colonoscopy quality including cecal intubation and adenoma detection rates and serious~     adverse event rates.~      This prospective study is the first in depth analysis of the quality of colonoscopic~     procedures performed by primary care physicians at a provincial level in Canada.~      In addition, the APC Endo study is the first to directly examine both the quality of~     colonoscopy and patient satisfaction in the same study.~   "
171480|NCT01320800|"~     This 5-year study addresses the unmet needs of adolescents with social phobia through the~     testing of a 12-week cognitive-behavioral, school-based group intervention delivered by~     trained school counselors compared to a nonspecific school counseling program. A secondary~     goal is to provide further examination of the efficacy of the CBT program delivered by school~     counselors as compared to the same program delivered by psychologists.~   "
171481|NCT01320787|"~     The goal of this clinical research study is to find out the highest tolerable dose of an~     imaging solution called 18-F-fluoroacetate sodium that can be given before a positron~     emission tomography (PET) scan. The safety of this solution will also be studied.~   "
171482|NCT01320774|"~     The purpose of this observational study is to evaluate the efficacy, tolerability, quality of~     life and handling of Daivobet® Gel by both physician and patient in daily practise.~   "
171483|NCT01320761|"~     To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately~     following injection and at regular intervals up to 24-hours post-injection following~     subcutaneous administration into the submental area.~   "
171484|NCT01320748|"~     The purpose of this study is to determine whether drug-dependent adults who participate in a~     dual processing relapse prevention treatment protocol that allows for sensory-based exposure~     experiences over 10-weeks in outpatient treatment will show significant brain change related~     to diminished cue reactivity, and greater improvement in self-efficacy, anxiety,~     somatization, and treatment retention, as compared to the standard care patients in a relapse~     prevention program.~   "
171485|NCT01320735|"~     The objective of this study was to describe treatment patterns of leuprorelin over 2 years~     using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)~   "
171486|NCT01320722|"~     The investigators hypothesize that, among non-hypertensive overweight and obese individuals,~     treatment of vitamin D deficiency and lowering uric acid concentrations (by either xanthine~     oxidase inhibition or increased renal excretion) will attenuate renin angiotensin system~     (RAS) activation, improve endothelial function, and lower blood pressure.~   "
171487|NCT01320709|"~     In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam~     will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone~     which triggers ovulation).~      Additionally blood levels of endogenous hormones (hormones produced by your body) will be~     measured and transvaginal ultrasound examinations will be conducted at regular intervals. In~     addition the concentration of piroxicam in blood will be determined in regular intervals.~      With regards to the tolerability of the study drug subjects will be asked regularly how they~     feel.~   "
171488|NCT01320696|"~     The purpose of the study is to identify the optimal dose level of a reverse genetic (RG)~     reassortant H9N2 pandemic influenza vaccine for further product development.~   "
171489|NCT01320683|"~     This phase II trial studies how well giving combination chemotherapy and bevacizumab before~     surgery and radiolabeled monoclonal antibody therapy works in treating liver metastases in~     patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as leucovorin~     calcium, fluorouracil, and oxaliplatin (FOLFOX), work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90~     DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing~     substances to them without harming normal cells. Giving chemotherapy and monoclonal antibody~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed. Giving radiolabeled monoclonal antibody therapy after surgery may kill any~     tumor cells that remain after surgery~   "
171490|NCT01320670|"~     Epilepsy, defined as recurrent, unprovoked seizures, is a common condition, affecting 0.5-1%~     of the general population. People with uncontrolled epilepsy suffer poor health and increased~     mortality due to their condition. They frequently experience social stigma and are~     socioeconomically disadvantaged. It is therefore imperative to help them gain control of~     their seizures as quickly as possible. A wide range of antiepileptic drugs (AEDs) has become~     available to treat people with epilepsy. However, despite maximal therapy, approximately~     20-40% show pharmacoresistance (PR) and thus continue to have seizures.~      We do not understand why a significant proportion of people with epilepsy have PR. For any~     given patient presenting with a first unprovoked seizure, we are unable to predict PR at the~     time of presentation. At least 2 different AEDs must be tried at maximum doses for a year~     before we can diagnose PR. At this point, surgical therapies become an increasingly urgent~     consideration.~      Retrospective magnetic resonance imaging (MRI) studies in the chronic stages of epilepsy have~     shown that patients with PR are more likely to have focal structural lesions in the brain,~     and in particular to have signs of damage to the hippocampi. For example, there are~     retrospective data suggesting that a decreased hippocampal N-acetylaspartate (NAA)/creatine~     ratio (measured by magnetic resonance spectroscopy [MRS]) and hippocampal atrophy (determined~     by hippocampal volumetry) correlate with PR. However, it is not clear whether these findings~     reflect the underlying pathophysiology of PR, or simply reflect the effects of chronic~     seizures and chronic drug treatment on the brain.~      The First Seizure Clinic at the Halifax Infirmary represents a unique opportunity for~     prospective, longitudinal studies of patients who present with a first seizure or with newly~     diagnosed epilepsy. In these patients, advanced neuroimaging techniques at presentation might~     show changes that truly reflect the underlying pathophysiology of PR, rather than changes~     that develop as a consequence of prolonged seizures and drug treatment. Neuroimaging~     follow-up might help us to understand the pathophysiologic changes that accompany the~     evolution of PR. Ultimately, it is our hope to combine neuroimaging features and clinical~     features of patients with PR in a predictive model that would help us to predict PR at~     presentation.~   "
171491|NCT01320657|"~     This is a clinical study involving patients undergoing orthodontic treatment with fixed~     appliances ('train-track braces'). A new type of train-track has recently been marketed. Over~     4 million patients worldwide are wearing on of these appliances; this system is considerably~     more expensive than a normal train-track. However, there is little evidence to support its~     use.~      The effects of three different types of train-track will be assessed with respect to the~     quality of Orthodontic tooth movement produced. Furthermore, the impact of the different~     train-tracks on daily life of orthodontic patients will also be measured. Consequently, the~     investigators will be able to inform orthodontists' decisions relating to the choice of~     train-track they recommend for their patients. In addition, should the more expensive~     appliances demonstrate objective or subjective advantage, a significant efficiency saving may~     develop.~   "
171492|NCT01320644|"~     Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce~     in regard to long term outcomes. This advanced procedure is offered at Morristown Memorial.~     THis protocol will review the one year outcome of patients who underwent this pocedure using~     a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.~   "
171493|NCT01320631|"~     The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor~     functional status and ultimately improving the patient's quality of life. There are a few~     studies that have explored the effect of pelvic reconstructive surgery on female sexual~     function (1,2) but no studies have evaluated the male partner's sexual experience. The~     investigators intend to use a newly psychometrically validated questionnaire to capture this~     aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and~     exclusively combine functional and quality of life concepts (erection, individual~     satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more~     focused and less burdensome evaluation of the sexual experience in men (3). Another issue is~     the density of the mesh material and if it can be felt vaginally even if it is not eroded and~     to what degree this might bother the male partner during intercourse.~   "
171494|NCT01320618|"~     Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce~     in regard to long term outcome. This advanced procedure is offered at Morristown Memorial.~     This protocol will review the one year outcome of patients who underwent this procedure using~     a polypropylene mesh. These outcomes will include anatomical and quality of life measures.~   "
171495|NCT01320605|"~     Compound HP802-247 comprises two topical sprays, administered sequentially right after~     another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface.~     HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg~     ulcers. The present study will enroll up to five patients who are suffering venous leg~     ulcers, have failed a prolonged course of standard wound therapy and one or more advanced~     technologies, but who would not qualify for the Phase 2 study.~   "
171496|NCT01320592|"~     This study is a phase I, single arm, open-label trial of PD0332991 in combination with~     Paclitaxel in patients with Rb-expressing metastatic breast cancer. Up to 20 patients are~     anticipated to be enrolled to reach the MTD of PD0332991 in combination with Paclitaxel. Once~     the MTD is established, an additional expanded cohort of 10 patients will be enrolled at that~     dose to establish the RP2D, obtain additional safety data and perform exploratory biomarker~     studies.~   "
171497|NCT01320579|"~     The purpose of this study is to evaluate dose response, safety, tolerability and efficacy of~     2.5% and 5% cis-UCA in comparison to placebo and active comparator in the treatment of adult~     patients with moderate or severe chronic atopic dermatitis.~   "
171498|NCT01320566|"~     The purpose of this study is to assess the long term safety and efficacy of AeriSeal System~     treatment administered at up to 4 subsegments during a single treatment session for lung~     volume reduction in patients with advanced emphysema through 48 weeks after treatment.~   "
171499|NCT01320553|"~     The present study will test if administration of different concentrations of 1334H eyedrops~     will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or~     older.~   "
171500|NCT01320540|"~     Currently, many breast center patients with a positive family history receive information~     about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery~     or at a time point that does not allow them to use testing results in making their surgical~     decision. Diagnostics, decisions and interventions are often out of sequence, resulting in~     test information not available in time for decisions. Tests are often repeated. Decisions and~     interventions are delayed, are not understood by breast cancer patients or proceed without~     the test information, resulting in suboptimal care and resource waste (Donaldson MS. 2005,~     Katz SJ 2007, IOM 2001).~      In this study, BRCA testing information will be delivered to patients at the point of breast~     imaging. For patients that are diagnosed with breast cancer, this provides ample time to use~     the test results in making their surgical decision, if they elect to be tested. The~     investigators will work with health care providers to insure family history data are~     collected at the breast imaging visit, develop a standardized BRCA patient education handout,~     enlist health care providers to insure the information is delivered to the appropriate~     patient population, and coordinate scheduling with genetic counseling services to insure~     patients are promptly seen.~      The investigators hypothesis is that an intervention of providing patients indicated for~     genetic/familial risk with timely information and opportunity to access genetic counseling~     during breast imaging will shift BRCA testing to before definitive breast cancer surgery, for~     patients with a breast cancer diagnosis, and could impact surgical decisions. The~     investigators will identify barriers to this intervention from the perspective of patients,~     physicians, nurses, and genetic counselors. The investigators will then adjust the~     intervention to overcome the barriers and will test the intervention at the point where~     genetic/familial risk assessment based on NCCN guidelines is (or should be) conducted at~     breast imaging. If indicated, patients will be provided information and will be referred to~     genetic counseling to consider BRCA tests.~   "
171501|NCT01320527|"~     Based on prior published pilot studies, the investigators have initiated a larger, multi-site~     placebo-controlled clinical trial with Alzheimer's disease (AD) patients and individuals~     diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying)~     the above promising clinical findings, and (2) determining whether or not our formulation can~     delay MCI conversion to AD.~   "
171502|NCT01320514|"~     The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in~     reducing the incidence of early postoperative bruising and swelling.~   "
171503|NCT01320501|"~     An open-label, prospective, single-arm, multi-center phase IV clinical trial of TarcevaTM as~     single agent~   "
171504|NCT01320488|"~     Breast cancer is the leading cancer among women in Saudi Arabia representing almost the third~     of cancer diagnosed in Saudi women. Breast cancer in Saudi women is more frequently observed~     at young age. The data on this observation is either lacking or scares. Furthermore, the~     pathological and molecular features of breast cancer in young women are not clear. The study~     will provide important information to the national health care planner about this disease in~     young women including shedding light on possible genetic risk factors~   "
171505|NCT01320475|"~     Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic~     and an opioid are generally associated to produce an epidural analgesia. However, opioid~     epidural administration is frequently associated with adverse effects as nausea, vomiting,~     urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an~     effective analgesic.~      The purpose of the study is to compare the epidural administration of levobupivacaine and~     sufentanil or the epidural administration of levobupivacaine associated with the iv~     administration of ketamine.~   "
171506|NCT01320462|"~     Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by~     varenicline and follow up by quit line) in the preoperative clinic is more effective than the~     simple preoperative smoking intervention (brief advice and provision of information about the~     quit lines ) in terms of short-term and long-term quit rates~      Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention~     (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in~     the preoperative clinic to help surgical patients quit smoking perioperatively and for the~     long-term.~   "
171507|NCT01320449|"~     Epo increases red blood cell production and hence the amount of oxygen that can be~     transported around the body. It is shown that prolonged use of synthetic Epo (rHuEpo) leads~     to an increase in the period of time a given physical work can be performed, therefore it~     will continue to be abused by athletes, especially in endurance sports.~      The existing method for measuring the abuse of rHuEpo approved by the World Anti-Doping~     Agency (WADA) is based on differences in the sugar groups bound to rHuEpo and Epo produced in~     the body, respectively.~      Proteomics is a method by which one can look at all the proteins in blood at the same time.~     Even proteins that have changed very little can be distinguished. The main objective of this~     project is to investigate the effect of prolonged treatment with rHuEpo on changes in blood~     proteins in healthy young men.~   "
171508|NCT01320436|"~     Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity in~     patients. The current standard treatment for mild to moderate UC (MTMUC) includes~     5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine, yet some patients~     continue to experience disease symptoms and flare-ups. These patients require higher dosages~     of 5ASA medications and in many cases escalate to steroid and/or immunosuppressant therapy~     which comprises higher risk of hazardous side effects.~      Curcumin, an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively~     studied in the context of inflammatory diseases. In humans, a controlled study using curcumin~     as an adjusted therapy to 5ASA medication has shown it to be superior to placebo in~     maintaining remission in MTMUC patients . A small, preliminary open label study has also~     shown efficacy in reducing disease symptoms and inflammatory markers in this group of~     patients .~      This data provides bases for investigating an integrative approach to optimize the current~     standard treatment in MTMUC patients. We speculate that using a combined therapy of 5ASA~     medication and curcumin could benefit this subgroup of patients and reduce morbidity and~     perhaps need for escalating pharmacological intervention.~   "
171509|NCT01320423|"~     To establish whether a policy of earlier surgical evacuation of the haematoma in selected~     patients with spontaneous lobar ICH will improve outcome compared to a policy of initial~     conservative treatment. The trial will also help to better define the indications for early~     surgery.~      This will overcome two of the criticisms of STICH (timing was too late and sometimes location~     was too deep). The subgroup identified in STICH is clinically sensible and the hypothesis~     identified for STICH II is in line with current neurosurgical opinion.~   "
171510|NCT01320410|"~     The study will comprise two dosing periods in two different cohorts of healthy volunteers.~     The investigators will begin with a single dosage period I (1 injection of 25 mg of~     Risperidone for each subject); single dosage period II, different from the previous one (1~     injection of 37.5 mg of Risperidone for each subject), in a second group of healthy~     volunteers different from the first group will not start until after a preliminary analysis~     has been made of the safety data and plasma concentration data are known for the formulation~     of prolonged release Risperidone using the ISM® technology.~   "
171511|NCT01320397|"~     The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more~     pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive patients~     carrying at least one of the pre-specified gene mutations. In previous studies has been~     demonstrated that these mutations are able to induce specific alterations inducing an~     increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial blood~     pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the impact of~     these alterations, and so directly reverse the increase in blood pressure.~   "
171512|NCT01320384|"~     The aim of the study is to compare, in patients with acute respiratory failure/acute lung~     injury the efficacy of three different methods of oxygenation to prevent endotracheal~     intubation :~        1. conventional oxygen therapy (O2 conventional)~        2. high flow nasal oxygen therapy (O2-HFN)~        3. association of high flow nasal oxygen therapy with non invasive positive pressure~          ventilation (O2-HFN/NPPV).~   "
171513|NCT01320371|"~     The purpose of this prospective study is determine if barbed sutures are more efficient, have~     comparable complication rates, clinical outcomes, and cosmesis outcomes versus traditional~     knotted sutures when used in the closure of primary total knee arthroplasty (TKA).~      Barbed suture has been associated with improved closure efficiency and safety in TKA in prior~     studies. The investigators performed a multicenter randomized controlled trial to determine~     the efficiency and safety of this technology in TKA. The investigators prospectively~     randomized 411 patients undergoing primary TKA to either barbed running (n=191) or knotted~     interrupted suture closure (n=203). Closure time was measured intraoperatively. Cost analysis~     was based on suture and operating room time costs.~   "
171514|NCT01320358|"~     The main purpose of this exploratory trial is to evaluate the reliability, safety and~     usability of the Transplantation Sensor System when the Ingestible Event Marker (IEM) is~     given in combination with ECMPS 360 mg tablets in adult renal transplant recipients.~   "
171515|NCT01320345|"~     The purpose of this study is to evaluate the potential benefits of Fenofibrate in 300 adults~     with Type 1 diabetes mellitus who are at high risk of eye damage.~   "
171516|NCT01320332|"~     The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and~     tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.~   "
171517|NCT01320319|"~     Primary Aim is to test the Hypothesis: Nutritional supplementation with 960mg EPA three times~     a day positively affects muscle function and mass (assessed by muscle biopsies, assays of~     cellular aerobic function and DEXA scan) and inflammation (measuring cellular markers of~     inflammation) in patients undergoing resection of colorectal cancers.~      The secondary aim is to evaluate aerobic performance assessed by cardiopulmonary exercise~     testing (CPEX) and perioperative outcome in patients with colorectal cancer post surgical~     resection.~   "
171540|NCT01320020|"~     The study is designed as an open-label dose-escalation study to investigate the safety and~     tolerability of catumaxomab qwk in patients with epithelial cancer. The treatment period for~     dose escalation (dose limiting toxicity (DLT) period) consists of 4 weeks, comprising 4~     single i.v. administrations of catumaxomab followed by 1 week for safety observations after~     each administration. All patients will be offered continuation of catumaxomab treatment at~     the same dose until disease progression or death, whichever occurs first.~   "
172078|NCT01312857|"~     The purpose of this study is to see if Panitumumab plus the other treatments will increase~     the time of remission. Remission means that there is no sign of the cancer.~   "
171518|NCT01320306|"~     The prevalence rate of intracranial aneurysms in the adult population is close to 5%. Rupture~     risk of such aneurysms causing subarachnoid hemorrhage (SAH) can be substantial.Most patients~     suffering from an aneurysmal SAH are in their mid life, i.e., 30 to 60 years old. Aneurysmal~     SAH may cause disability and mortality. The present study includes a follow-up study and a~     cross-sectional fMRI study. The purpose of the follow-up study is to monitor patients~     receiving prophylactic surgical treatment of their un-ruptured aneurysms to examine whether~     such treatment is associated with cognitive, psychosocial and/or neurologic sequela. The~     purpose of the cross-sectional fMRI study is to examine the relationship between memory~     function and brain activity among SAH patients. Memory impairment is often found among~     aneurysmal SAH patients. Using fMRI can possibly shed some light on whether such memory~     impairment may be caused by diffuse cerebral damage or a focal damage at the aneurysm site.~   "
171519|NCT01320293|"~     Severe psoriasis has been demonstrated to be associated with decreased endothelial function~     and an increase risk of future coronary events. Although systemic therapy with~     immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic~     inflammation and endothelial function are unknown.~      In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and~     inflammatory markers before and after treatment of moderate to severe psoriasis with an~     FDA-approved biologic agent, adalimumab (Humira).~   "
171520|NCT01320280|"~     The purpose of this study is to find out what effects, good and/or bad, BIBW 2992 (Afatinib)~     has on patients and their advanced prostate cancer which does not respond to hormone or~     chemotherapy any more. Only patients with tumors which have an increased amounts of a protein~     called HER2 on their cell surface will be included.~      BIBW 2992 (Afatinib) is a drug which in advanced clinical testing in lung and breast cancer.~   "
171521|NCT01320267|"~     The investigators will document the success for completing laparoscopic resection of cancer~     in the right colon using a new single port access technique. The current procedure requires 4~     incisions for 4 separate ports. With technological advancement of newly designed instruments~     it is now possible to do the same laparoscopic procedure through a single port. The~     investigators want to demonstrate here in British Columbia that it is a safe procedure with~     similar success and outcomes compared to the standard 4-port laparoscopic operation.~      The investigators propose that this procedure may provide early discharge due to less pain~     and also be associated with less wound infection and hernia complications. The single~     incision will have improved cosmesis compared to the standard 4-port standard laparoscopic~     procedure.~   "
171522|NCT01320254|"~     The purpose of this study is to determine the efficacy of panitumumab plus~     cisplatin/gemcitabine (CisGem) combination chemotherapy in KRAS wild-type biliary tract~     cancer patients without systemic pre-treatment, compared to the historical data and to the~     randomised control group without the antibody, which verifies the historically based~     assumption.~   "
171523|NCT01320241|"~     Malignant biliary obstruction is a common clinical condition caused by various malignancies.~     Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the~     most important methods for relieving malignant biliary obstruction. However, the benefit for~     the survival of the patients with palliation of the stent treatment is limited because no~     therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the~     success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with~     125I radioactive seeds has been developed in our institute. After ex vivo and in vivo~     evaluations for the delivery system, the investigators prospectively compare the responses to~     treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient~     with malignant biliary obstruction.~   "
171524|NCT01320228|"~     The objective of the Orlifat trial is to investigate if dietary fibres from linseeds and~     dairy calcium (Capolac ®) may reduce gastrointestinal side effects related to increased fecal~     fat content, induced by treatment with Alli® (orlistat). Secondly, effect on food intake,~     anthropometry, Quality of Life and cardiovascular risk markers will be evaluated. The trial~     is designed as a randomised 2 x 2 factorial 13-weeks parallel intervention, in which 72 obese~     participants will be randomised to supplementation with flaxseed fibres and/or dairy calcium~     concentrate (Capolac) in addition to treatment with Alli ®:~        1. Alli® (60 mg t.i.d) plus placebo (rice flour)~        2. Alli® plus 5 g flaxseed fibers~        3. Alli® plus 1200 mg Ca from Capolac~        4. Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac~   "
171525|NCT01320215|"~     The primary objective of this study is to compare 30-day complication rates associated with~     promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic~     technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include~     comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality~     of life and medico-economic data between the two techniques.~   "
171526|NCT01320202|"~     The purpose of this study is to confirm the safety and efficacy of Soluble Ferric~     Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in~     anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will~     be measured primarily by the change from baseline in hemoglobin (Hgb).~   "
171527|NCT01320189|"~     The objective of this study is to determine ad libitum daily energy and protein intake,~     energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12~     consecutive days, also as a function of age, gender, BMI and FTO polymorphisms.~   "
171528|NCT01320176|"~     This study aimed to evaluate the safety and reactogenicity of two intramuscular injections of~     two different dosages of an investigational clade B HIV vaccine.~   "
171529|NCT01320163|"~     This study is designed to determine whether a functional difference exists between the~     laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received~     neuromuscular blockade.~   "
171571|NCT01319617|"~     The purpose of this investigation is to study the safety and tolerability of SENSIMED~     Triggerfish, a soft contact lens-based device intended to continuously record relative~     changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and~     glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an~     ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24~     hours and side effects are the main endpoints of the investigation.~   "
171572|NCT01319604|"~     The purpose of the investigation is to investigate the relationship between the study device~     output and tonometric assessments.~   "
171530|NCT01320150|"~     Osteoarthritis (OA) is the single most common cause of disability in mid and late life. About~     27 million people in the United States suffer from this incurable process and 10 million have~     OA of the knee. Total knee replacement (TKR) is a reliable treatment option for patients~     disabled by knee OA who have failed non-operative treatment; 58% of these surgeries are~     performed on patients 65 years or older. Despite the overall success of TKR in most cases,~     persistent postsurgical pain (PPP) of the operated knee remains a common and often difficult~     to treat postoperative outcome affecting 13-20% of all patients at 6 months post-TKR, which~     amounts to 65,000-100,000 patients/year in the USA. Important secondary outcomes of PPP are~     restricted physical mobility and poor quality of life, especially in older patients.~      Recent findings spanning the pre-, intra- and postoperative periods suggest that the~     development of PPP after TKR is a multi-factorial process, comprised of both neurophysiologic~     and psychosocial factors. Likely determinates include preoperative thermal pain sensitivity,~     anxiety, pain catastrophizing; and postoperative area of secondary mechanical hyperalgesia or~     hypoalgesia (numbness). There is already agreement that the intensity of early (acute)~     postoperative pain is one of the factors predicting PPP. To date, most studies have examined~     the role of risk factors in isolation and/or within a single domain, and no prospective study~     has comprehensively evaluated the interaction of neurophysiologic and psychosocial variables~     in the evolution of PPP following TKR. The lack of information regarding how neurophysiologic~     pathways and patient cognitive/affective states interact over time following otherwise~     successful TKR has greatly undermined the understanding of PPP after TKR.~      The proposed project is a single-site, prospective study of 300 OA patients aged 18-85 yrs~     undergoing primary TKR. The study is designed to identify factors from the pre-, intra- and~     postoperative phases of TKR that contribute to PPP at 6 months. Specific risk factors were~     selected because they are potentially modifiable, and therefore may be amenable to~     intervention. Patients will be assessed from pre-surgery to 6 months post surgery. The~     proposed multi-factorial and prospective approach to investigating risk factors is a vital~     next step towards understanding the complex phenomenon of PPP.~   "
171531|NCT01320137|"~     The purpose of this study is to develop and characterize immunological assays on blood~     samples.~   "
171532|NCT01320124|"~     A contracture is a pathological condition limiting range and function of joints. Contractures~     of large and small joints alike will affect one's ability to independently perform daily~     activities such as eating, dressing or walking. Current treatments for contractures include~     physical stretching, the use of assistive devices or, rarely, surgery. Despite prolonged~     treatments, patients with contractures rarely regain complete mobility. Progress in~     preventing and treating contractures will be possible only through an understanding of the~     biological and molecular processes involved. Our group has established and validated an~     animal model to study the histological events and the molecular mechanisms involved in joint~     contractures. We have provided evidence for capsule stiffness, characterized cartilage~     degeneration, and identified four genes whose expression is altered in the cartilage of a~     knee joint with contracture. The work we propose in the current study aims at finding genes~     and pathways in the joint capsule associated with knee joint contractures. The results will~     identify new avenues for treating the large number of patients suffering from contractures.~   "
171533|NCT01320111|"~     AIM OF STUDY~      Primary Efficacy Variable:~      The primary study objective is the proof of efficacy, measured by progression free survival~     (PFS) in the treatment of metastatic or locally inoperable recurrent breast cancer.~      Progression-free survival (PFS) is defined as the time from randomisation to disease~     progression or death.~      Secondary Efficacy Variables:~        -  Clinical benefit (CR+PR+SD)~        -  ORR (CR+PR)~        -  Time to progression~        -  Time to next Treatment (TTT)~        -  Overall survival~        -  Safety profile~   "
171534|NCT01320098|"~     The purpose of this research is to evaluate and compare the effectiveness of two parenting~     programs in reducing the ADHD symptoms and behavioral problems of preschool children with~     ADHD through a controlled study. One program is a home-based parent training intervention~     that is designed to enhance the parent-child interaction, constructive parenting skills, and~     the child's tolerance for delay. The other intervention is a clinic-based parent training~     program that focuses on reducing noncompliance in preschool children and improving parenting~     skills.~      Both programs consist of private weekly parenting sessions with Clinical Psychologists - once~     a week for 8 weeks. The sessions are 1-1.5 hours in length. Both programs use behavior~     modification as a means of improving oppositional and non-compliant child behavior. Both~     interventions also involve procedures that focus on improving children's attention.~      Neither program involves medication, and all families will receive one of the two parenting~     programs being evaluated. Study evaluations, as well as participation in the parenting~     programs, are provided at no cost to families. Evaluation and parenting sessions can be~     scheduled at times convenient to families.~   "
171535|NCT01320085|"~     The study will assess the safety and efficacy of single-agent MEK162 in adult patients with~     locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring~     BRAFV600E or NRAS mutations.~   "
171536|NCT01320072|"~     To diagnose aspirin hypersensitivity in asthmatics by using and safe, low-dose aspirin oral~     challenge.~      Hypothesis 1: A low dose of oral ASA (20 or 40 mg) will induce significantly different~     concentrations of arachidonic acid metabolites in ASA-sensitive asthmatics as compared to~     ASA-tolerant asthmatics.~      Hypothesis 2: The low dose (20 or 40 mg) ASA challenge will be well tolerated by~     ASA-sensitive asthmatics.~   "
171537|NCT01320059|"~     The goal of this clinical research study is to learn if an imaging solution called~     18F-PEG6-IPQA can help to find tumors when used in positron emission tomography (PET) scans.~     The safety of the solution and how the solution is processed by your body will also be~     studied.~   "
171538|NCT01320046|"~     Vulvar contact dermatitis (VCD) is a common problem presenting as vulvar pruritus, burning or~     irritation. Its estimated prevalence is 20-30% in vulvar clinics, but the prevalence in the~     general population is unknown.~      Contact dermatitis is an inflammation of the skin resulting from an external agent that acts~     as an irritant or as an allergen. The skin reaction may be acute, subacute or chronic,~     resulting from prolonged exposure to weak irritating substances.~      The most common form of VCD is irritant contact dermatitis, and it usually presents as vulvar~     itch. The causes that contribute to VCD are increased sensitivity of the vulvar skin to~     irritants compared to other body parts, decrease in the skin barrier function due to exposure~     to sweat, urine and vaginal discharge and constant friction of the vulvar area. In menopausal~     women, lack of estrogen contributes to tissue atrophy and thinning, and may increase the~     effect of irritants on the vulvar skin.~      One of the most common irritating substances that cause VCD is urine. The phenomenon of~     urine-induced VCD is known as diaper rash in babies, and it was also described in bedridden~     patients using diapers constantly. Women with urine incontinence (UI), a problem that its~     prevalence in women increases with aging, may use constantly panty liners or pads to prevent~     urine leakage. The urine is being absorbed in the pad, and the vulvar skin is continually~     exposed to urine. This can cause VCD, similar to diaper rash. The prevalence of this~     phenomenon in the general population is unknown.~      The patients complain of itch, burning or irritation of the vulvar skin, and on exam~     erythema, edema and irritated skin are found. As most patients do not connect between UI to~     their vulvar disorder, and as most care-givers do not ask routinely about UI, the vulvar~     symptoms are mistakenly attributed to yeast infection or other factors. As the cause to the~     vulvar complaints is not recognized, patients do not receive proper treatment that requires~     primary management of UI.~      The aim of the study is to evaluate the prevalence of VCD in women with UI and to recognize~     risk factors for UI induced VCD.~   "
171539|NCT01320033|"~     The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for~     16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry~     Forward, Intent To Treat) in inflammatory lesion counts.~   "
171541|NCT01320007|"~     Heart failure is a major clinical problem that is increasing in magnitude and the cost of~     management of heart failure is escalating. A significant part of this cost is related to~     unplanned acute presentation to emergency departments and hospitalisation with worsening~     shortness of breath due to increased fluid content in the lungs.~      Many heart failure patients are already fitted with defibrillators to protect them from the~     risk of fast heart rhythms and sudden death and are followed up in both the heart failure~     clinics and defibrillator clinics. Recently some of the defibrillators fitted have been~     equipped with an extra function that can detect and warn of changes in the fluid content of~     the lungs very early even before the patient starts to complain of any shortness of breath~     and before any signs of fluid overload are seen clinically. However, it is not known how to~     deal with these warnings if they occur very early and it is not known whether a medical~     intervention at his stage is beneficial to prevent progression and eventual hospital~     admission. In the majority of cases, early warnings of this kind are ignored or this function~     is disabled at implantation of the device.~      The current study will involve patients who have already been fitted with a device with the~     above capability. The investigators will use the new function to guide management of these~     patients and compare their outcome with similar patients who are fitted with devices without~     it. The investigators will attempt to manage early warnings by a predetermined increase in~     medications in a group of patients and compare their clinical course to a similar group in~     whom no action is taken.~   "
171542|NCT01319994|"~     According to current estimates, nearly 1% of the general population is treated with long-term~     glucocorticoids. Chronic hypercortisolism leads to a phenotype that resembles the metabolic~     syndrome. The investigators have shown that inhibition of adenosine-monophosphate-activated~     protein kinase (AMPK) activity in adipose tissue plays a role in corticosteroid-mediated~     insulin resistance. Metformin, one of the mainstay therapies for type 2 diabetes, is a known~     activator of AMPK, which mediates its beneficial effects on glucose and lipid metabolism. The~     investigators have shown in an animal model that metformin - via altering AMPK activity -~     prevents the development of the metabolic complications of glucocorticoid excess, and the~     investigators wish to confirm this in a human study. The aim of this prospective, randomised,~     double-blind, placebo-controlled study is to investigate the effect of metformin treatment on~     metabolic parameters in patients on long-term high-dose glucocorticoids. The study is part of~     the investigators translational project and could rapidly lead to immediate patient benefit,~     improving quality of life and reducing health care costs for the NHS.~   "
171543|NCT01319981|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if intensive chemotherapy (hyper-CVAD~     therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab~     for patients who are CD20 positive and/or imatinib, dasatinib, or ruxolitinib for patients~     with the Philadelphia (Ph) chromosome, can help to control ALL or lymphoblastic lymphoma. The~     safety of this treatment will also be studied. CD20 is a protein marker that is found in~     leukemia or lymphoma cells.~      This is an investigational study. Liposomal vincristine is FDA approved for the treatment of~     patients with CLL who have relapsed at least 2 times. All of the other study drugs used in~     this study are FDA approved and commercially available. The combination of liposomal~     vincristine with the other study drugs is also being used in research only.~      Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.~   "
171544|NCT01319968|"~     Postpartum dyspareunia (PD) is a recognized phenomenon: it is estimated that 50-60% of women~     have dyspareunia 6 to 7 weeks following delivery, and 33% and 17% will still report pain~     during intercourse three and six months after delivery, respectively.~      Studies that evaluated the prevalence and the causes for PD referred primarily to obstetric~     trauma, such as vaginal tears, episiotomy, the mode of repair and damage to the pelvic floor~     muscles as probable causes for PD. These studies did not refer to estrogen deficiency and the~     possible effect of breastfeeding on vaginal atrophy and its contribution to PD. Comparison~     between vaginal deliveries and cesarean sections revealed that there is no difference in the~     prevalence of PD between the two groups, and according to these findings it can be assumed~     that the mechanical trauma to the vagina and pelvic floor during delivery is not the main~     cause for the development of PD.~      Vaginal atrophy due to estrogen deficiency is a common cause for postmenopausal dyspareunia.~     With estrogen deficiency, profound changes occur in the vagina: vaginal mucosa becomes thin~     and pale or hyperemic and loose her flexibility. Blood flow decreases, normal vaginal~     discharge is reduced, and maturation of epithelial cells do not take place in the absence of~     estrogen. Women with estrogen deficiency may complain of dryness, pruritus, irritation,~     burning, dysuria, pain and dyspareunia. These changes are reversible by estrogen, given~     systemically or topically, and cause resolution of clinical findings, as well as~     disappearance of symptoms in several weeks.~      Similar to postmenopausal patients, breastfeeding women immediately after delivery,~     experience decline of estrogen levels, and this decline may persist as long as lactation is~     continued. Therefore, many women after delivery may experience vaginal atrophy due to~     transitional lack of estrogen. It is possible that this atrophy is the cause for the high~     rate of PD.~      Our clinical experience shows that many women present with postpartum dyspareunia with~     vaginal atrophy, and that vaginal atrophy is responsible for part or most of their~     complaints. Although most gynecologists recognize atrophy easily in menopausal women, vaginal~     atrophy is not recognized correctly in most puerperal patients and therefore do not receive~     attention and proper treatment.~      The aim of the study is to characterize the phenomenon of postpartum vaginal atrophy in terms~     of prevalence, risk factors and duration, and the association between vaginal atrophy and~     postpartum dyspareunia.~      We also intend to evaluate the effect of vaginal treatment with estriol cream 0.1% (Ovestin~     cream) on postpartum dyspareunia.~      The study will expand our knowledge regarding postpartum dyspareunia and will enable~     formulating recommendations for evaluation and treatment of PD.~   "
171545|NCT01319955|"~     Pneumonia is the leading cause of child death worldwide. Data from Bangladesh indicates that~     influenza has a substantial association with pneumonia among children less than two years~     old. This study will use commercially available trivalent inactivated vaccine (killed~     vaccine) to see if it can prevent early childhood pneumonia among children less than two~     years old. The study will vaccinate children across three seasons (3 years), and look at the~     effect on the attack rate of pneumonia, as well as its effects on laboratory-confirmed~     influenza. It will also look at the effect on laboratory-confirmed influenza illness among~     the non-vaccinated household contacts of all ages of these children.~   "
171546|NCT01319942|"~     This study aims to test the efficacy of combined radiotherapy and sorafenib in patients with~     locally advanced hepatocellular carcinoma.~   "
171547|NCT01319929|"~     To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of~     LY2828360 in male and female subjects with osteoarthritic knee pain~   "
171548|NCT01319916|"~     Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous~     Injection of ATX-101 into Abdominal Fat Tissue~   "
171549|NCT01319903|"~     The novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory~     response to various stimuli in humans and espacially during sepsis. Purpose of this phase I~     clinical trial in healthy human males is to investigate various parameters concerning safety~     and tolerability of CaCP29 and assess pharmacokinetic and pharmacodynamic parameters.~   "
171550|NCT01319890|"~     Current evidence regarding the optimal surgical approach to potentially curable right colonic~     cancer is based on numerous, well designed randomised controlled clinical trials. Currently,~     eminence based opinion suggests that an alternative surgical technique, single incision~     laparoscopic surgery (SILS), may improve short and long term outcomes after minimally~     invasive right colonic resection. A true, prospective analysis comparing standard of care~     (laparoscopic right hemicolectomy) and this new therapy(SILS) has yet to be published.~     Having established the optimum treatment modality the minimally invasive approach to right~     colonic tumors the results will be communicated at national and international meetings.~   "
171551|NCT01319877|"~     This observational study will evaluate the safety and efficacy of Bevacizumab in combination~     with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese~     participants with metastatic colorectal cancer. Data will be collected from each participant~     for up to 3 years.~   "
171552|NCT01319864|"~     In this Phase I study, we will test the safety of the drug plerixafor (MOBOZIL) at different~     dose levels, used together with other anti-cancer drugs—cytarabine and etoposide. We want to~     find out what effects, good and /or bad, this combination of drugs has on leukemia.~     Plerixafor is a drug that blocks a receptor on the leukemia cell, which prevents it from~     staying in the bone marrow where it can be resistant to chemotherapy. Plerixafor is FDA~     approved for mobilizing stem cells from the bone marrow in preparation for an autologous stem~     cell transplant. Cytarabine and etoposide have been used as part of standard chemotherapy for~     ALL and AML. However, the use of plerixafor with cytarabine and etoposide in pediatric~     patients with relapsed or refractory ALL, AML and MDS is considered experimental.~   "
171553|NCT01319851|"~     Allogeneic blood and marrow transplantation remains the only viable cure for children who~     suffer from many serious non-malignant hematological diseases. Transplantation, however,~     carries a high risk of fatal complications. Much of the risk stems from the use of high dose~     radiation and chemotherapy for conditioning, the treatment administered just prior to~     transplant that eliminates the patients' marrow and immune system, effectively preventing~     rejection of the donors' cells. Attempts to make blood and marrow transplantation safer for~     children with non-malignant diseases by using lower doses of radiation and chemotherapy have~     largely failed because of a high rate of graft rejection.~      In many such cases, it is likely that the graft is rejected because the recipient is~     sensitized to proteins on donor cells, including bone marrow cells, by blood transfusions.~     The formation of memory immune cells is a hallmark of sensitization, and these memory cells~     are relatively insensitive to chemotherapy and radiation. Alefacept, a drug used to treat~     psoriasis, on the other hand, selectively depletes these cells. The investigators are~     conducting a pilot study to begin to determine whether incorporating alefacept into a low~     dose conditioning regimen can effectively mitigate sensitization and, thereby, prevent~     rejection of allogeneic blood and marrow transplants for multiply transfused children with~     non-malignant hematological diseases.~   "
171554|NCT01319838|"~     Neuroblastoma is a cancer of the nervous system and accounts for 15% of cancer related deaths~     in children. With the advancement of treatment therapies, the long term survival rate has~     progressed to approximately 50%. The therapy used for treatment, however, is very toxic and~     associated with serious long-term side effects. Treatment for neuroblastoma typically~     includes chemotherapy, surgery, stem cell transplantation, radiation therapy, and~     immunotherapy. At the end of this treatment, children with neuroblastoma commonly take the~     drug isotretinoin for 6 months. Isotretinoin maintains the response to previous treatments~     and helps turn the remaining cancer cells into normal nerve cells.~      Most patients often respond to this treatment at first but are at a high-risk for the cancer~     coming back. The majority of the children who relapse after treatment or develop recurrent~     disease do so in the first two years following the completion of therapy and there are no~     current treatments to cure those who relapse. This study will explore whether or not~     extending the therapy with isotretinoin from 6 months to 24 months will help prevent the~     cancer from coming back without causing severe side effects.~   "
171555|NCT01319825|"~     This is an open label pilot study to determine whether milnacipran can reduce headache~     frequency in episodic and chronic migraine sufferers.~   "
171556|NCT01319812|"~     The objective of this study is to separately demonstrate the safety and efficacy of~     BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of~     femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal~     popliteal artery (PPA), while the Astron stent will be used for the treatment of the common~     or external iliac artery lesions.~   "
171557|NCT01319799|"~     The use of MRI have shown that the incidence of postoperative cerebral lesions due to~     cerebral embolization is high (1). Nonetheless the extent of postoperative neurological~     dysfunction is only a fraction of the actual amount of new postoperative changes detected on~     MRI. Transcranial Doppler (TCD) has shown the occurrence of extensive microembolic signals in~     intracerebral arteries during open heart procedures (2). The clinical significance of~     cerebral microemboli is not clear (3-5). The use of serological markers to assess cerebral~     injury after open cardiac surgery is difficult to interpret. The levels of markers seems to~     be contaminated from extracerebral sources (6). In order assess the release of markers of~     neuronal damage after open aortic valve surgery the investigators intend to examine the~     levels of S-100B, NSE and Tau in cerebrospinal fluid (CSF) by comparing the levels~     preoperative with the levels one day after surgery. Furthermore the investigators will~     determine the total amount of cerebral microembolic signals during the surgical procedure by~     means of TCD. The investigators will statistically test if there is any correlation between~     the increase in cerebrospinal fluid levels of S-100B,NSE and Tau and the cerebral embolic~     load.~   "
171573|NCT01319591|"~     The purpose of this study is to compare different estimates of calculating creatinine~     clearance by mathematical formula and compare them to creatinine clearance based on a timed~     urine collection in patients who received high-dose methotrexate for the treatment of primary~     CNS lymphoma or CNS involvement of systemic lymphoma.~   "
171574|NCT01319578|"~     The specific purpose of this study is to describe the characteristics of the K2CG chewing~     gum, specifically as it relates to duration of gum chewing (exposure), timing of gum chewing~     in relation to a meal, and dose of K2CG chewing gum.~   "
176609|NCT01253486|"~     This study will determine whether the psychological and physical benefits of expressive~     writing extend to obese in-patients with Ischemic Heart Disease (IHD)referred to cardiac~     rehabilitation~   "
171558|NCT01319786|"~     Previous work has shown that increasing fruit and vegetable intake in patients with high~     blood pressure improves cardiovascular function. Research indicates that this may be partly~     owing to compounds called polyphenols, which are found in abundance in fruits and vegetables~     and other foods such as wine, tea and dark chocolate. The investigators now wish to test if~     consuming fruits and vegetables (including berries which are very rich in polyphenols), as~     well as dark chocolate, has further benefits for cardiovascular function. A total of 110~     subjects with high blood pressure will be recruited and asked to follow a low polyphenol diet~     (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four weeks (a~     washout period). They will then be randomised to continue this diet or to consume 6 portions~     of fruits and vegetables (to include 1 portion berries) and 1 portion of dark chocolate daily~     for 8 weeks. The fruit, vegetables and dark chocolate will be provided free of charge and~     delivered to the homes of the participants who are randomised to the high fruit and vegetable~     arm of the study.~      Assessment of microvascular and platelet function will be undertaken before and after~     consuming this diet. Improvements in these tests of cardiovascular function have previously~     been linked to reduced risks of heart disease in people with high blood pressure. This study~     will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of~     developing heart disease.~   "
171559|NCT01319773|"~     This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of~     cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group~     phase will be followed by a paired-eye phase which will evaluate the safety and tolerability~     of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic~     emulsion (RESTASIS®) in patients with dry eye.~   "
171560|NCT01319760|"~     A prospective, randomized, controlled multi-site feasibility trial to assess the potential~     role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation~     myocardial infarction (STEMI)~   "
171561|NCT01319747|"~     Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) and~     surgically video assisted thorascopic pulmonary vein isolation (VATS-PVI) are acceptable or~     even superior alternatives to antiarrhythmic drug therapy in patients with symptomatically~     paroxysmal atrial fibrillation (AF). However, data comparing effectiveness in both~     interventions are limited.~      The investigators want to compare the effectiveness of PVI and VATS-PVI. Secondary objectives~     are to compare the duration of hospitalization, quality of Life, cost and to compare the~     satisfaction of the patients.~   "
171562|NCT01319734|"~     Null hypothesis:~      No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular~     complications of type 2 Diabetes Mellitus (DM).~      Alternative hypothesis:~      There is a significant effect of vitamin C 500mg supplementation on the severity of the~     micro-vascular complications of type 2DM.~   "
171563|NCT01319721|"~     To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane~     graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium removal~     in patients with recurrent pterygium.~   "
171564|NCT01319708|"~     The investigators will examine the balance between IVF success in terms of outcome~     parameters, using a mild ovarian stimulation protocol, opposing it to the conventional~     stimulation regimens in poor responders undergoing IVF.~   "
171565|NCT01319695|"~     The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as~     compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation~     protocols in women undergoing in vitro fertilisation.~   "
171566|NCT01319682|"~     This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine~     injection on the relief of pain in patients undergoing 1-level posterior lumbar fusion.~      A total of 54 patients will be randomized into one of two groups (group C or group I) based~     on Excel number generation.~      Patients in group C will receive received normal saline intravenous injection, and patients~     in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a~     continuous lidocaine infusion of 2 mg/kg/hr.~      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients~     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12,~     24, 48 hours postoperatively.~   "
171567|NCT01319669|"~     To assess the efficacy and safety of administration of rhTPO at different time in the~     treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung~     cancer (NSCLC)~   "
171568|NCT01319656|"~     The aim of PR1MaC is to establish a clinical intervention that will adapt and permanently~     integrate rehabilitation services into primary care settings, which would be the reference~     point in the health care system for people with Chronic diseases (CD). More specifically, the~     intervention will aim to: (1) clinically operationalize the mechanisms and tools necessary~     for delivery of integrated CD services, promoting continuity of care in response to the needs~     expressed by stakeholders; (2) implement and deploy rehabilitation services adapted to the~     realities of various clinical primary care settings and develop tools to ensure the~     sustainability of interventions beyond the rehabilitation period; and (3) support clinical~     primary care teams in the acquisition and maintenance of evidence-based practices for the~     targeted CDs.~   "
171569|NCT01319643|"~     Oxygen administration is a common practice in intensive care units, although concern is~     growing about oxygen toxicity. The aim of the study is to access whether a rigorous~     maintenance of a state of normal oxygenation in critically ill patients could obtain better~     outcomes, such as mortality, infections and organ failures, in comparison to conventional~     oxygen therapy practice.~   "
171570|NCT01319630|"~     Major microvascular blood flow alterations have been documented in patients with severe~     sepsis. It was also demonstrated that the microcirculation improved in survivors of septic~     shock but failed to do so in patients dying from acute circulatory failure or with multiple~     organ failure after shock resolution. Early, effective fluid resuscitation is a key component~     in the management of patients with severe sepsis and septic shock with the goal of improving~     tissue perfusion. The best fluid in this early resuscitation phase has been and still is~     under debate. The aim of this study is to evaluate the effect of Three different~     Fluids(Albumin 5%, Normal Saline, HES 130 kD) on microcirculation in severe sepsis/septic~     shock patients using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy~     (NIRS) analysis.~   "
171575|NCT01319565|"~     Background:~      - An experimental treatment for metastatic melanoma involves cell therapy, in which~     researchers take white blood cells (lymphocytes) from the tumor tissue, grow them in the~     laboratory in large numbers, and then use the cells to attack the tumor tissue. Before~     receiving the cells, chemotherapy is needed to temporarily suppress the immune system to~     improve the chances that the tumor-fighting cells will be able to survive in the body. In~     some studies of cell therapy, individuals who have received total body irradiation (TBI) in~     addition to the chemotherapy (in order to increase the length of time that they do not~     produce white blood cells) seem to have a slightly better response to the treatment, but it~     is not known if adding radiation to the cell therapy will cause a better response for all~     individuals. Researchers are interested in comparing cell therapy given with the usual~     chemotherapy to cell therapy given with the usual chemotherapy and TBI.~      Objectives:~      - To compare the effectiveness of cell therapy given with chemotherapy to cell therapy given~     with chemotherapy and total body irradiation in individuals with metastatic melanoma.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          and tumor imaging studies.~        -  Participants will be divided into two groups: cell therapy with chemotherapy alone~          (group 1) or cell therapy with chemotherapy plus TBI (group 2).~        -  All participants will provide a tumor sample from either surgery or a tumor biopsy for~          white blood cell collection.~        -  Participants will have leukapheresis to collect additional white blood cells for cell~          growth and future testing, and TBI group participants will also provide stem cells to~          help them recover after radiation. (TBI participants who cannot provide enough stem~          cells will be moved to the non-radiation treatment group.)~        -  Participants will have chemotherapy with cyclophosphamide (two treatments over 2 days)~          and fludarabine (five treatments over 5 days) starting 7 days before the cell therapy.~          Participants in the TBI group will also have TBI for the 3 days immediately before the~          cell therapy.~        -  All participants will receive the white blood cells, followed by high-dose aldesleukin~          every 8 hours for up to 5 days after the cell infusion to help keep the therapy cells~          alive and active. Participants will also have injections of filgrastim to stimulate~          blood cell production, and participants in the TBI group will also receive their stem~          cells.~        -  Participants will take an antibiotic for at least 6 months after treatment to prevent~          pneumonia, and will be asked to return for regular monitoring and followup visits for at~          least 5 years to evaluate the tumor s response to treatment.~   "
171576|NCT01319552|"~     Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to~     transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest~     that certain patients transfused with blood stored for longer duration have poorer outcomes~     than patients transfused fresher blood. The investigators' hypothesis is that the delivery of~     an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood~     leads to changes that explain the differences in outcome between patients transfused old~     versus fresh blood. The investigators propose to test this hypothesis in humans by~     transfusing an individual's own blood, both fresh and after storage, and comparing levels of~     various outcome measures.~   "
171577|NCT01319539|"~     This phase II trial is studies how well Akt inhibitor MK2206 works in treating patients with~     stage I-III breast cancer that can be removed by surgery. Akt inhibitor MK2206 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
171578|NCT01319526|"~     RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment~     with HIV infection and Hodgkin lymphoma may help doctors learn more about the effects of~     therapy on HIV.~      PURPOSE: This research study is studying biomarkers in blood samples from patients with HIV~     infection and stage III or stage IV Hodgkin lymphoma undergoing chemotherapy.~   "
171579|NCT01319513|"~     Protein ingestion increases the rate at which the body builds new proteins in skeletal muscle~     (muscle protein synthesis. This study is designed to examine how the pattern of feeding~     affects muscle protein synthesis following resistance exercise. There is reason to believe~     that the large rapid increase in blood amino acid concentrations that accompanies the~     ingestion of a bolus of protein is important to increasing muscle protein synthesis. Thus, we~     hypothesize that the consumption a bolus of protein will elevate muscle protein synthesis to~     a greater extent than the consumption of an equivalent amount of protein that is consumed in~     small divided doses.~   "
171580|NCT01319500|"~     This study investigates the drug utilization pattern of Oral Contraceptives (OC) in Croatia.~     Gynecologists and Dermatologists were asked to contribute OC prescribing data to this study.~   "
171581|NCT01319487|"~     The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low~     dose) administered in the eye are more effective than placebo in treating patients with~     diabetic macular edema, following 12 weeks of treatment.~   "
171582|NCT01319474|"~     This study seeks to determine the rate of thromboembolic complications (blood clots),~     including death attributed to thromboembolic disease, when anticoagulation (blood thinner)~     therapy is withheld from pregnant patients suspected of deep vein thrombosis (DVT) after a~     whole-leg compression ultrasound shows no DVT. Patients are followed for three months after~     the ultrasound to determine if a blood clot is diagnosed during that time.~   "
171583|NCT01319461|"~     Evaluate the efficacy and safety of Hyalgan, at a dose of 20mg/2ml administered as 5~     intraarticular injections at weekly intervals, for the sustained relief of pain and~     amelioration of joint dysfunction in patients of OA of the knee.~   "
171584|NCT01319448|"~     Malaria prophylaxis is recommended for sickle cell disease patients. In Nigeria, daily~     proguanil or weekly pyrimethamine are the most commonly prescribed regimens, but the current~     policy is not effective due to poor compliance and drug resistance. Intermittent treatment~     with a long acting drug regimen administered under supervision at clinic visits may be more~     effective. The aim of this trial is to compare the tolerability and acceptability of~     supervised bimonthly treatment with either sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ)~     or mefloquine plus artesunate (MQ+AS), with the daily proguanil. Two hundred and seventy~     patients with sickle cell disease attending the paediatric sickle cell disease clinic in~     Ilorin hospital who meet the eligibility criteria and have parental consent, will be~     randomized to one of three prophylactic regimens: daily proguanil, bimonthly~     sulfadoxine-pyrimethamine plus amodiaquine, or bimonthly mefloquine plus artesunate. Patients~     will be asked to return to clinic every two months and whenever they are sick. At enrollment,~     the study paediatrician will conduct a physical examination of the child, and collect a~     venous blood sample for a complete blood cell count and biochemical screen, determination of~     G6PD genotype, preparation of blood smears for malaria microscopy and a blood spot for~     determination of molecular markers of resistance. Four days after each clinic visit, patients~     will be interviewed (by phone and, for a subset, at home or in the clinic) to ask about~     compliance and adverse events. Participants will be followed for one year. The parents or~     carer will be encouraged to bring their child to the Outpatient Department clinic if the~     child becomes unwell. The primary outcome of the trial is tolerability, secondary outcomes~     are adherence to the regimen, and incidence of malaria and the number of hospitalizations~     over 12 months. If the bimonthly regimens are well tolerated and the preliminary data from~     this study are promising, a larger multicentre trial will be required to determine efficacy.~   "
171585|NCT01319435|"~     Phase I, open-label study to evaluate the pharmacokinetics, tolerability and short-term~     safety of ciprofloxacin in neonates with suspected (or proven) Gram Negative infection.~     Objectives: To evaluate the multiple-dose pharmacokinetics of ciprofloxacin in neonates and~     young infants (24 - 52 weeks postmenstrual age) with suspected or proven Gram Negative~     infection.~      To evaluate the tolerability and describe short-term safety of ciprofloxacin in neonates and~     young infants with suspected (or proven) Gram Negative infection.~      To describe the clinical outcomes of neonates treated with ciprofloxacin~   "
172177|NCT01311531|"~     The treatment of unstable, non-reducible distal radial fractures is still controversial. The~     aim of the present study is to compare the subjective, clinical and radiographic outcome of~     the TriMed fragment-specific system with a volar locking plate in patients with unstable,~     non-reducible and also redislocated distal radial fractures.~   "
171586|NCT01319422|"~     Lenalidomide has clinical activity in myeloma. The closely related compound, Pomalidomide,~     may have clinical activity in patients who have previously been treated with lenalidomide and~     who no longer respond to it. The mechanism of anti-tumor effects of these drugs has been~     attributed to several effects including anti-angiogenesis, immune activation, and~     anti-proliferative effects. Recent studies have suggested that these agents can mediate~     surprisingly rapid biologic effects on human monocytes and T cells. Our hypothesis is that~     the proximate effects of these drugs will be sensitive and quantitative surrogates of~     subsequent effects including activation of tumor antigen specific T cells as well as innate~     immune cells. Understanding the correlation between the pharmacodynamics of these effects~     with downstream activation using quantitative assays will facilitate the rational development~     of pomalidomide as immune-modulatory drug in diverse settings as well as its optimal~     development in myeloma therapy.~   "
171587|NCT01319409|"~     The purpose of this double-blind, randomized clinical trial to compare outcomes of~     single-bundle (SB) to anatomic double-bundle (DB) ACL reconstruction. We hypothesize that~     anatomically reconstructing both bundles of the ACL will lead to better restoration of~     healthy knee mechanics and clinical outcomes. In addition to standard clinical outcome~     measures, we will utilize a unique combination of high-speed biplane radiography (for highly~     accurate assessment of knee kinematics) and 3D imaging (MRI and CT, to define joint and~     cartilage morphology) to characterize joint kinematics and cartilage surface interactions~     during functional tasks.~      The specific aims of this study are to:~      Specific Aim 1: Determine if anatomic double-bundle ACL reconstruction restores normal~     dynamic knee function better than single-bundle ACL reconstruction.~      Hypothesis 1.1 Knee kinematics after anatomic double-bundle ACL reconstruction are more~     similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as~     measured with dynamic stereoradiography 6 and 24 months after surgery.~      Hypothesis 1.2 Graft elongation from 6 to 24 months after surgery is reduced with anatomic~     double-bundle ACL reconstruction in comparison to single-bundle ACL reconstruction, as~     measured with dynamic stereoradiography.~      Specific Aim 2: Determine if anatomic double-bundle ACL reconstruction results in better~     clinical outcomes than single-bundle ACL reconstruction.~      Hypothesis 2.1 Anatomic double-bundle ACL reconstruction will result in more symmetrical~     laxity and better range of motion and hop test scores in comparison to single-bundle ACL~     reconstruction.~      Hypothesis 2.2 In comparison to single-bundle ACL reconstruction, anatomic double-bundle ACL~     reconstruction will result in better patient-oriented outcomes, indicating fewer symptoms, a~     higher level of activity and more complete return to sport.~      Successful completion of these aims will provide quantitative evidence of the efficacy of~     anatomic double-bundle ACL reconstruction for restoring normal knee mechanics. Should the~     results show a clear benefit for this procedure, it would provide support for wider~     adaptation of anatomic DB reconstruction. By completing the proposed aims, we will also~     establish a sound basis for additional studies with longer follow-up (including the subjects~     in this cohort), to assess the benefits of anatomic DB ACL reconstruction for improving~     long-term clinical outcomes and maintaining joint and cartilage health.~   "
171588|NCT01319396|"~     The purpose of this study is to compare the accuracy of the BiancaMed BM07 breathing~     frequency indicator device with the respiration rate measured by a SomnoScreen RC Easy device~     on 20+ human volunteers. This is being carried out in support of a 510(k) submission.~   "
171589|NCT01319383|"~     The purpose of this study is to compare HIV RNA expression and infection within resting~     (CD4)+ cells in HIV-infected patients on stable ART before and after a single exposure to~     Vorinostat (VOR), after exposure to short intervals of VOR, and after repeated short interval~     exposure to VOR dosed over several weeks.~      Hypotheses:~        1. The frequency of resting CD4+ T cell- associated HIV RNA (RCVL) will be increased~          following single and repeated exposure to VOR when given at appropriate intervals, and~        2. That repeated exposure to VOR will reduce the frequency of HIV infection within resting~          CD4+ T cells (RCI)~   "
171590|NCT01319370|"~     The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical~     Foam (MTF) formulation compared to placebo in the temple region of male patients with~     androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and~     safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2~     years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all~     patients will get the equal treatment and measurements in the vertex region to enable~     comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline~     but also to vertex region. Additionally safety assessments will be performed throughout the~     whole study.~   "
171591|NCT01319357|"~     Diabetes mellitus is a metabolic disease with a growing prevalence worldwide. Currently~     available therapies for type 2 diabetes have various limitations and are associated with~     increased risk of hypoglycemia, weight gain, gastrointestinal side effects or edema and heart~     failure.~      A new and promising class of drugs are the gliptins. Several efficacy studies demonstrated a~     significant improvement of HbA1c with gliptins. In addition, gliptins improved fasting as~     well as prandial glucose levels and did not induce weight gain. Due to these positive~     metabolic effects in combination with a very small spectrum of side effects gliptins might~     very well be part of the standard therapy for type 2 diabetes in the future.~      Apart form surrogate parameters like reduction of fasting and postprandial blood glucose~     levels or improvement of HbA1c, the effect of gliptins on micro- and macrovascular function~     and cardiovascular outcome has not been the primary focus of current studies. Diabetes~     mellitus is strongly associated with microangiopathy and macroangiopathy and is a strong~     independent risk factor for cardiovascular disease and cardiovascular mortality. Endothelial~     dysfunction which plays a crucial role in the atherosclerotic process is commonly observed in~     patients with diabetes mellitus and already prediabetes and has - amongst other factors -~     been linked to fasting and postprandial hyperglycemia. Taken into account that gliptins~     reduce hyperglycemia and hyperglycemic peaks by preventing inactivation of GLP-1, which~     exerted beneficial effects on the endothelium in previous studies it is of major interest~     whether therapy with gliptins improves endothelial function.~   "
171604|NCT01319188|"~     The investigators assume that ranibizumab might be dangerous in patients with history of~     coronary artery disease or cerebrovascular events. The main objective of study is to reveal~     contraindications for ranibizumab prescription in patients with history of coronary artery~     disease and cerebrovascular events. Moreover, an association between management with~     ranibizumab and ATE rate in healthy above 50 years old persons is a concern of great interest~     as well.~   "
171605|NCT01319175|"~     Strength training of the hip flexors using elastic bands can induce an effect on isometric~     hip strength of at least 15 %.~   "
171616|NCT01319032|"~     In a study conducted in our laboratory few years ago, we genotyped 22 genes in 2 athletic~     groups (endurance and sprinters) and in age and gender matched nonathletic controls. Few of~     these genes were found to be associated with athletic performance and area of specificity.~     Since then a few more genes have been found that are related to athletic performance, and we~     intend to study various genes related to 3 genetic cascade: genes associated with body fluid~     balance and homeostasis, genes associated with muscle strength, and genes associated with~     bioenergy. The results of this study compared with athletic level will provide deeper insight~     into the genetic mechanisms involved in performance.~   "
171592|NCT01319344|"~     Patients with the metabolic syndrome (MetSyn) are at increased risk for cardiovascular~     mortality and morbidity.This increased cardiovascular risk is attributed to metabolic~     dysregulations like impaired glucose tolerance or diabetes mellitus and dyslipidemia,~     abdominal obesity and arterial hypertension, which promote oxidative stress and inflammation~     with consecutive endothelial dysfunction causing an atherogenic environment.~      Aldosterone promoted end organ damage is mainly found in the cardiovascular system and the~     kidney. Inflammation and activation of different factors promotes fibroblast growth and~     matrix production resulting in myocardial fibrosis, vascular remodelling and renal fibrosis.~      MetSyn and aldosterone are cardiovascular risk factors and it is of crucial importance to~     note that there is a connection between MetSyn and aldosterone. Other cross sectional studies~     show a direct correlation of aldosterone levels and impaired glucose metabolism in patients~     with and without the MetSyn. Taken together, aldosterone influences essential parameters of~     the MetSyn. Coincidentally parameters of the MetSyn are stimulus for an increased aldosterone~     synthesis, i.e. visceral adipocytes.~      In large scale clinical trials - RALES, EPHESUS, 4E - inhibition of MR has proven to be~     beneficial in patients with congestive heart failure and post myocardial infarction and this~     result has been confirmed for diabetic patients, who are known to have an increased~     cardiovascular risk.~      There is only very limited data on the impact of MR inhibition on metabolic, endocrine, and~     inflammatory parameters in patients with MetSyn, who have not yet suffered from~     cardiovascular events.~   "
171593|NCT01319331|"~     The purpose of this study is to determine if the drug Alpha-1 Antitrypsin (AAT, Aralast NP)~     will preserve beta-cell function and help slow the progression of type 1 diabetes.~   "
171594|NCT01319318|"~     This study will evaluate the degree of post-operative ocular inflammation in patients who are~     undergoing a pars plana vitrectomy.~   "
171595|NCT01319305|"~     This is a long-term follow-up of patients that participated in the BREATHE I study.~   "
171596|NCT01319292|"~     Asthma is the most common chronic respiratory disease in children and has much effect on~     their life and study, which leads to huge economic burden and pressure to the whole families.~     Some children will develop into adult patients so that asthma can be the life-long vigorous~     trouble. In recent years, the prevalence rate of children asthma is increasingly going up~     worldwide. The prevalence rate in last 12 months reported in USA, United Kingdom, Australia,~     New Zealand was between 12% to 30%.~      Center for Asthma Prevention and Education of Capital Institute of Pediatrics investigated~     the national asthma prevalence in 900 thousands children in 27 provinces and cities, which~     average rate was 0.11% to 2.03% in 1990. In 2000, we investigated it again in 31 provinces(43~     cities) and the average national children asthma prevalence rate was 1.97%(0.25% to 4.63%)~     which was much higher than that in 1990.~   "
171597|NCT01319279|"~     The purpose of this study is:~        1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in~          subjects with moderate hepatic impairment and in subjects with normal hepatic function.~        2. To assess the safety and tolerability of the hydrocodone bitartrate extended-release~          tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic~          function.~   "
171598|NCT01319266|"~     The purpose of this study is to assess the effect of varying degrees of renal impairment~     (mild, moderate, severe and end stage renal disease) compared with subjects with normal renal~     function on the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.~   "
171599|NCT01319253|"~     This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and~     laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that~     alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that~     alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic~     Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model~     biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing~     clinical and microbiological parameters.~   "
171600|NCT01319240|"~     This trial is conducted in Europe. The aim of this trial is to compare the bioavailability of~     insulin degludec and liraglutide, when administered either combined or as separate~     administrations.~   "
171601|NCT01319227|"~     This is a randomized clinical trial comparing two different uncemented femoral stems and two~     different uncemented sockets using Dual-energy x-ray absorptiometry, Radiostereometry and~     clinical evaluation.~      Hypothesis:~        1. A short uncemented stem gives less periprosthetic bone resorption in the proximal femur~          than a conventional uncemented stem.~        2. An uncemented acetabular component with a backside of three-dimensional Titanium porous~          construct gives less periprosthetic bone resorption than a backside covered with a~          conventional porous coating with Titanium-beads and a hydroxy-apatite layer.~   "
171602|NCT01319214|"~     The primary objective is to investigate the potential ability of Inderal (propranolol~     hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in~     cocaine dependent participants. If effective in this laboratory model, Inderal may have~     clinical efficacy.~   "
171603|NCT01319201|"~     Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different~     Glycaemic Status~      Aims:~      To evaluate coronary artery calcification and stenosis in community-dwelling adults with~     different glycaemic status, using dual-source CT angiography (CTA)~      Study Subjects and Methods:~      200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR)~     and 200 with type 2 diabetes were recruited from an urban community of Shanghai, who then~     underwent a comprehensive examination including questionnaire, anthropometric measurements,~     biochemical analysis and CTA.~      Part II: Follow-up of Cardiovascular Events and Re-evaluation of Coronary Artery~     Calcification and Stenosis~      Aims and Methods:~      To investigate the development of cardiovascular diseases in subjects recruited in part I and~     re-evaluate coronary artery calcification and stenosis using CTA after 3-year follow-up~      To identify the predictive value of coronary artery calcification and stenosis with future~     risks of cardiovascular diseases and the possible development of coronary artery disorders~     among participants with different glycaemic status~   "
171617|NCT01319019|"~     This study is primarily designed to assess the dose response, dose interval, efficacy and~     safety of three once daily (QD) doses (100mcg, 400mcg and 800mcg) and three twice daily (BID)~     doses (100mcg, 200mcg and 400mcg,) of GSK961081 administered via DISKUS™ for 28 days in~     subjects with moderate/severe COPD versus placebo. Salmeterol 50mcg BID is included in the~     study as an active comparator.~   "
171606|NCT01319162|"~     Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese~     and obesity is closely linked to the development of PCOS. Although it is well established~     that obesity increases the severity of the clinical features of PCOS, data regarding the~     prevalence of PCOS in obese women and the change in body weight in women with PCOS over time~     are scares. In a prevalence study it was investigated whether obesity increases the risk of~     PCOS in the general population and they demonstrated that the prevalence rate of PCOS in~     underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%,~     respectively, similar to that observed in the general population. These results suggest that~     the risk of PCOS is only minimally increased with obesity. On the other hand, in a Spanish~     prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence of~     PCOS, which is markedly higher compared with the 5.5% prevalence of PCOS in lean women in~     Spain.~      First the investigators aim to estimate the prevalence/probability of PCOS among obese,~     premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms~     in Sweden. Secondly, to elucidate whether women diagnosed with PCOS respond to standard~     weight reduction regime to the same extent as women without PCOS.~   "
171607|NCT01319149|"~     A retrospective molecular diagnostic review on wound care outcomes. The time periods include~     March, April, May of 2010.The retrospective review would analyze the days of healing during~     the timeframe, upon the introduction of molecular diagnostic testing~   "
171608|NCT01319136|"~     Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt~     surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the~     cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for~     shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients~     that had a preoperative investigation because of communicating hydrocephalus at the~     university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of~     this study was to evaluate a new method, with a new infusion protocol and new analysis~     methods, and compare it to the current method.~   "
171609|NCT01319123|"~     This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing~     against wound bioburden in moderately to highly exuding venous leg ulcers.~   "
171610|NCT01319110|"~     Specific Aim #1: To determine if levels of CoQ10 are low post-cardiac arrest (CA). We will~     perform a prospective trial with the primary endpoint of describing the prevalence of low~     serum CoQ10 levels.~      Specific Aim #2: To determine if CoQ10 levels in post-CA patients can be increased with the~     administration of exogenous CoQ10.. We will perform a randomized control trial (RCT) of~     post-CA patients with the secondary endpoint of comparing CoQ10 levels among those randomized~     to CoQ10 supplementation vs placebo.~   "
171611|NCT01319097|"~     This is a clinical study to evaluate the effects of sorbion sachet s wound dressing on soft~     tissue edema and wound bioburden in moderately to highly exuding pressure ulcers.~   "
171612|NCT01319084|"~     Considering the development of gastric cancer surgery using da Vinci Robotic Surgical System,~     the development of educational program needs to be achieved in Korea and this institute.~     Moreover, because of the large number of gastrectomy including robotic surgery for gastric~     cancer treatment, the investigators can provide high quality of educational program using da~     Vinci System. Therefore, the investigators wanted to create an innovative real-time training~     module, which can provide an intraoperative step-by-step guide to robotic surgical~     procedures. This technological project was named as Advanced Robotic Multi-display~     Educational System (ARMES).~   "
171613|NCT01319071|"~     It is still unknown whether different genetic elements play a role in athletes' ability to~     create their area of specificity.In a study conducted in our laboratory few years ago, we~     genotyped 22 genes in 2 athletic groups (endurance and sprinters) and in age and gender~     matched nonathletic controls. Few of these genes were found to be associated with athletic~     performance and area of specificity. Since then a few more genes have been found that are~     related to athletic performance, and our aim in the current study is to expand our research~     to these new genes which include 3 genetic cascades: genes associated with body fluid balance~     and homeostasis, genes associated with muscle strength, and genes associated with bioenergy.~   "
171614|NCT01319058|"~     Tonsil surgery for children suffering from obstructive sleep apnea have significant post~     operative morbidity including pain and occasionally bleeding. This morbidity is partly caused~     by post surgical inflammation. This inflammatory process can be quantified using various~     proinflammatory cytokines.~      the goal of this study is to objectively compare the inflammatory process after treatment of~     obstructive sleep apnea with different surgical approaches to the enlarged tonsils.~   "
171615|NCT01319045|"~     Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is common in~     patients with congenital heart disease. Historically these patients suffered significant~     morbidity and mortality due to a lack of effective therapies. More recently, advanced~     therapies which target the mechanisms underlying the development and progression of PAH have~     been introduced into clinical care. Oral, intravenous, subcutaneous, and inhaled therapies~     are all available for the treatment of PAH. Patients with PAH are first treated with oral~     agents (including sildenafil and bosentan). However, if these agents fail to achieve the~     desired effect for the patient, intravenous or inhaled therapies may be initiated.~     Combination therapy with multiple agents is common in routine clinical care. However, the~     most efficacious therapeutic regimen has yet to be delineated. The present study seeks to~     evaluate the efficacy of one specific regimen: iloprost, an inhaled prostacyclin derivative,~     used in combination with oral therapy (sildenafil and/or bosentan). Iloprost has been~     approved by the FDA for use in this patient population. Adults with PAH already receiving~     oral therapy will be invited to participate in this study. Iloprost will be added to their~     current therapeutic regimen for a period of three months, with pre- and post-treatment~     assessments. These will include a cardiopulmonary exercise test, BNP (a blood test), six~     minute walking distance, and a quality of life questionnaire.~   "
171618|NCT01319006|"~     A randomized, open-label, 3-period crossover study.~   "
171647|NCT01318629|"~     Many patients undergoing coronary angiography are found to have no significant coronary~     artery disease (CAD) despite angina equivalent symptoms and/or electrocardiographic~     abnormalities suggestive of myocardial ischemia. The aim of this study is to systematically~     assess patients with angina equivalent symptoms despite normal coronary angiograms and to~     evaluate their symptoms according to a defined algorithm.~   "
171619|NCT01318993|"~     An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice~     daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous~     GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157~     (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment~     change may be eligible to participate. The primary objective is to evaluate the safety of~     GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters,~     vital signs and electrocardiogram. Secondary objectives will include assessments of~     effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will~     include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and~     Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.~   "
171620|NCT01318980|"~     GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that~     attenuates the production of leukotrienes through the blockage of the first step in the~     leukotriene pathway, 5-lipoxygenase (5-LO) activation. GSK2190915 inhibits the production of~     leukotriene B4 (LTB4) and cysteinyl leukotrienes (cysLTs).~      This is an open label, 4-way, 4-treatment period, non-randomised, crossover study with an~     interim analysis. The GSK2190915 formulations used in this study will be: a 100mg and 200mg~     milled tablet, a 100mg enteric-coated tablet, and a [14C] radiolabelled GSK2190915~     intravenous solution.~      This study aims to determine the pharmacokinetics and absolute bioavailability of GSK2190915~     to enable optimisation of suitable formulations to be used in clinical development Fourteen~     subjects will be dosed to ensure data in 10 at the end of the clinical study. Seven of the~     subjects will receive an IV microtracer in addition to the other treatments.~   "
171621|NCT01318967|"~     Comparison of renal blood flow measurements by PAH clearance and MRI~   "
171622|NCT01318954|"~     This study will evaluate whether exhaled nitric oxide levels are affected by allergen~     immunotherapy (allergy shots). The investigators' hypothesis is that successful allergen~     immunotherapy may be accompanied by decreased exhaled nitric oxide levels.~   "
171623|NCT01318941|"~     This study will describe the long-term safety and effectiveness, treatment patterns,and~     patient reported quality of life associated with ranibizumab treatment in routine clinical~     practice for all approved indication included in the local product label.~   "
171624|NCT01318928|"~     The purpose of this study is to examine if the correct use of antibiotics, as well as the~     application of one-day-treatment, in the therapy of periodontal diseases. The population of~     treated patients (184) are divided in 4 groups; Group 1: Metronidazole + mechanical treatment~     in one day, Group 2: Placebo + mechanical treatment in one day Group 3: Metronidazole +~     mechanical treatment on day 1 and 21 Group 4: Placebo + mechanical treatment on day 1 and 21~     End points, BOP, Plaque, PPD, CAL, RAL, Microbiology will be recorded on all sites at 3~     months, 1 -, 3 -, and 5 years post-treatment~   "
171625|NCT01318915|"~     The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at~     the time of the transplant surgery, will help reduce or eliminate the need for long term~     immunosuppressive medication.~   "
171626|NCT01318902|"~     This study will include patients with previously treated systemic relapsed or refractory~     light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the~     safety profile and the maximum tolerated dose/recommended phase 2 dose of IXAZOMIB~     administered orally.~   "
171627|NCT01318889|"~     Oral mucositis can be a significant problem for cancer patients. It is typically associated~     with pain and increased risk of infection and can lead to impaired nutritional status and~     inadequate hydration.it can be seen in the patient population receiving high-dose head and~     neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving~     stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness~     and elasticity. The stimulation of epithelization, granulation and mitigation of itching were~     the most prominent effects of formulations containing dexpanthenol. The investigators suppose~     that dexpanthenol mouth wash may improve oral mucositis.~   "
171628|NCT01318876|"~     Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or~     drifts, and its safety profile may vary. While generally considered safe, influenza vaccines~     have been associated in the past with increases in cases of Guillain-Barré syndrome (1976)~     and with oculorespiratory syndrome in 2001. Last year, with the vaccination against the~     pH1N1, an increase of allergic-like reactions was observed.~      Passive surveillance is collecting notifications of adverse events (AE) on the whole~     population but the sensitivity of this system is not high and its timeliness is not~     necessarily optimal. Last year, with the new pandemic Influenza vaccine the investigators~     piloted a web-based active surveillance of a large number of health care workers (HCW)~     vaccinated with the new adjuvanted monovalent pH1N1 influenza vaccine (Arepanrix® GSK,~     Canada). Because healthcare workers (HCW) constituted a well-defined group with general good~     health and received the Influenza vaccine in priority, this group of people was well suited~     for monitoring the safety of the influenza vaccine. For this study, 6242 HCW were recruited~     in three different sites (5183 were from Quebec). A total of 468 events (local reactions,~     fever, systemic reactions, gastrointestinal and respiratory problems) were reported by 430~     HCW. 80% of the HCW recruited completed at least one of the three surveys and 52% responded~     to all questionnaires. During this surveillance, the investigators didn't have unexpected~     findings but this active surveillance of adverse events among healthcare workers would have~     been effective enough to rapidly detect adverse events occurring at a rate ≥ 1 per 200~     vaccinees. For this year the investigators want to expand the surveillance to more sites and~     more participants to be able to detect AE occurring at rates ≥ 1 per 500 vaccinees, and to~     increase the response rate to all three surveys in participants.~      The main objective of this project is to estimate in HCW vaccinated against influenza the~     frequency of adverse events of sufficient severity to cause work absenteeism or medical~     consultation.~      This year the network will include 5 Canadian hospitals (Quebec City, Vancouver, Toronto,~     Halifax, + another one ) with a total enrollment of >10 000 HCW. This should allow us to~     detect AE occurring at a rate of ≥ 1 per 500 vaccinees.~   "
171629|NCT01318863|"~     More than one site will participate in the collection of blood and urine samples from healthy~     adult subjects. These samples will be used for future testing to serve as aged-matched normal~     controls and to establish normal reference ranges in the development of new invitro~     diagnostic devices.~   "
171630|NCT01318850|"~     Cognitive Remediation Therapy (CRT) can enhance cognitive performance in patients with~     schizophrenia improving clinical outcome. However, the neurobiological mechanism underlying~     cognitive improvement is not well understood. The aim of this study is to investigate~     functional connectivity patterns before and after the neurocognitive rehabilitation therapy,~     especially in fronto-temporal circuitry.~   "
171631|NCT01318837|"~     This study is to evaluate change of over active bladder symptom scores (OABSS) between,~     before and after solifenacin treatment to OAB subjects.~   "
171632|NCT01318824|"~     To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory~     failure.~   "
171633|NCT01318811|"~     Heparin is commonly used for anticoagulation of the extracorporeal circuit during continuous~     renal replacement therapy (CRRT) but the optimal mode of delivery has not yet been validated.~     Our study will compare dilute heparin to a standard concentration of heparin. The~     investigators hypothesize that heparin delivered in a dilute solution will augment coating of~     the filter fibers with anticoagulants, decreasing clotting events and increasing filter life.~     By improving delivery of heparin to the filter and circuit, where clotting events can disrupt~     dialysis, less heparin would be required for the extra-corporeal circuit and thus less~     heparin would be delivered back to the patient with blood return from the machine. By~     exposing the patient to less heparin it is hypothesized that fewer bleeding events would~     occur, making the dialysis treatment safer. If more of the filter's fibers remain patent and~     the filter is functional for a longer period of time, the CRRT would also be more effective.~   "
171634|NCT01318798|"~     Post-operative acute renal failure is a severe post-operative complication and is associated~     with high mortality. The enhanced prediction score, including pre-as well as intra-operative~     predictors accurately predicted ARF following hepatic surgery. This prediction score allows~     early identification of patients at high risk of ARF and may support decision-making for~     protective kidney treatment.~   "
171635|NCT01318785|"~     Examination of therapeutical effects of different types of armsleeves in treating lymphatic~     diseases after breast cancer surgery during maintenance phase~        1. thesis:~           - all types should be equal regarding volume reduction~        2. thesis: armsleeves manufactured with microfibre yarn are expected to be~             -  better in wearing comfort and~             -  better in handling features.~   "
171636|NCT01318772|"~     The purpose of this study is to acquire the clinical data required by the United States Food~     and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution~     imaging system for fluoroscopy/radiography. It is expected that the new KALARE~     (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of~     30 cases will be submitted for evaluation of claims for intended clinical applications.~   "
171637|NCT01318759|"~     This is a comprehensive Geriatric Assessment (CGA) currently used to evaluate elderly people~     in order to be able to assess their multiple organ pathology, cognitive, functional and~     social problems. This CGA is a very time consuming tool although a powerful one.~      The investigators want to present a new assessment test witch is short and comprehensive tool~     witch will be checked in ambulatory and in-hospital geriatric patients.~   "
171638|NCT01318746|"~     The potassium value is important to prevent cardiac arrhythmias and sudden cardiac death. In~     patients with renal failure, the potassium value is not stable and tends to raise. Until now~     there are no data available if the potassium value has a circadian rhythm and if there are~     individual changes from day to day.~   "
171639|NCT01318733|"~     A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5%~     once daily in subjects with moderate to severe facial erythema associated with rosacea.~   "
171640|NCT01318720|"~     Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on~     techniques for the treatment of neck pain is an intervention commonly implemented in clinical~     practice. Recently researchers and clinicians have implemented manual therapy techniques to~     the thoracic spine (midback) to treat patients with neck pain. To date no studies have~     examined the short-term combined effects of thoracic spine manual therapy and cervical spine~     manual therapy in the treatment of patients with mechanical neck pain. The purpose this study~     is to assess the combined effects of thoracic spine thrust manipulation with cervical spine~     non-thrust manipulation in patients with neck pain.~   "
171641|NCT01318707|"~     The purpose of this study is to compare the standard collection of whole blood in tiger top~     tubes for serum collection versus a collection method of added FVIII to whole blood samples~     in the hemophilia population for routine biomarker assays to ensure reliable assay results.~   "
171642|NCT01318694|"~     This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy~     [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment~     in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)~   "
171643|NCT01318681|"~     This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory~     functions. Our group has previously shown that patients suffering from AR symptoms perform~     less well on tasks requiring sustained attention compared to non symptomatic controls. Car~     driving is a typical behavior that is susceptible for changes in sustained attention and~     might therefore become worse under conditions when patients suffer from AR symptoms. We will~     compare the driving performance of untreated, symptomatic AR patients with the performance of~     symptomatic patients that have been treated with either a systemic AR medication (a pill) or~     a topical medication (nasal spray)~   "
171644|NCT01318668|"~     In this study the effects of a nicotine challenge on brain activity, behavior and mood will~     be evaluated in two groups of healthy volunteers who have a smoking habbit: The first group~     will undergo a series of treatments with NicVax, aimed at producing nicotine antibodies in~     the body and preventing nicotine to enter the brain. The second group will receive a placebo~     treatment. This pre-treatment (vaccination) will take place over a 18-week period. All~     participants will then undergo two days of testing. On each day the subjects will perform a~     number of psychomotor and memory tests after a challenge with nicotine (gum) or placebo(gum).~     Also brain activity will be studied in an fMRI scanner. We expect to see an effect on brain~     activation and performance only in the placebo-vaccinated group. The Nicvax vaccinated group~     should show activation and performance comparable to that after challenge with placebo(gum)~     as in this group nicotine should not cross the blood brain barrier and enter the brain~   "
171645|NCT01318655|"~     The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy~     subjects.~   "
171646|NCT01318642|"~     This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled~     trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally~     advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be~     randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo.~     Randomization will be stratified by ECOG (0 or 1).~      Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every~     28 day cycle. Treatment will continue until radiographic disease progression, unacceptable~     toxicity, withdrawal of consent, or start of a new anti-cancer therapy.~   "
171648|NCT01318616|"~     The purpose of this study is to investigate the effect of strength training with elastic~     bands on hip strength in soccer players, the effect measured with hand-held dynamometry. The~     primary outcomes are isometric and eccentric hip adduction strength. The hypothesis is that~     strength training with elastic bands will result in a clinical relevant increase in hip~     adduction strength.~   "
171649|NCT01318590|"~     The purpose of this study is to determine if celiac bloc (with injection of steroid and local~     anesthetic) is superior to a sham procedure for pain control and quality of life improvement~     in patient with chronic pancreatitis and abdominal pain.~   "
171650|NCT01318564|"~     The goal of this clinical research study is to test an investigational type of packaging for~     diabetes drugs called unit-dose packaging. Researchers want to learn if unit-dose packaging~     can help patients with Type II diabetes to take their drugs on the proper schedule.~   "
171651|NCT01318551|"~     Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single~     dose group stratified study in renal impaired and healthy subjects.~   "
171652|NCT01318538|"~     The purpose of this Stage II randomized controlled behavioral treatment development trial was~     to test the effectiveness of the Women's Recovery Group (WRG) relative to mixed-gender Group~     Drug Counseling (GDC) and demonstrate the feasibility of implementing the WRG in an~     open-enrollment (i.e., rolling admission) group format at two clinical sites. The Stage II~     trial aims were to (1) investigate effectiveness of the WRG relative to GDC in a sample of~     women heterogeneous with respect to substance use and co-occurring psychiatric disorders, and~     (2) demonstrate the feasibility of implementing WRG in an open enrollment group format~     characteristic of community treatment programs at two sites.~   "
171653|NCT01318525|"~     Acute liver failure is a rare but dramatic disease, often affecting young people, marked by~     the sudden loss of liver function in a person without preexisting liver disease.~      ALF-5755 has been shown to promote cell survival after apoptotic or oxidative stress, and~     liver cell regeneration in primary cultures and in vivo. ALF-5755 may become, in this~     dramatic disease with high unmet medical need, a future therapy for the treatment of patients~     suffering from severe acute hepatitis (SAH) and acute liver failure (ALF) not due to~     acetaminophen overdose, where liver transplantation is the sole treatment in the absence of~     spontaneous recovery.~      The primary objective of the study is to evaluate the efficacy of ALF-5755 versus placebo.~      A minimum of 60 patients will be recruited into the study in the following two treatment~     groups:~        -  Group A: approximately 30 patients will receive ALF-5755~        -  Group B: approximately 30 patients will receive placebo (physiological saline solution:~          0.9% NaCl)~      Patients will receive 10 mg (25 ml) of ALF5755 or placebo every 12 hours over 3 days in slow~     intravenous infusions over 10 minutes using automatic syringes.~   "
171654|NCT01318512|"~     This observational, prospective, multicenter study will describe the mean dose of Mircera~     (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic~     kidney disease. Patients are not on dialysis and are naive to, or have received~     erythropoiesis stimulating agent treatment. Data will be collected for 10 months.~   "
171655|NCT01318499|"~     The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic~     Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and~     pain in the eye after cataract extraction.~   "
171656|NCT01318486|"~     The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the~     heparin free treatment can be performed easily (without saline flushes or blood predilution)~     and is at least not inferior and maybe superior to the standard care heparin free treatment~     in terms of clotting.~   "
171657|NCT01318473|"~     This will be a prospective, single-arm, single-center, open-label study to evaluate the use~     of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm~     undergoing CT-guided percutaneous chest aspiration.~      Target location will be in the chest area; the procedure will be performed by a trained~     physician.~   "
171658|NCT01318460|"~     The present pilot study aims to investigate the effectiveness of the preoperative infusion of~     levosimendan in patients with impaired left ventricular function undergoing coronary artery~     bypass grafting.~   "
171659|NCT01318447|"~     This prospective, multicenter study is intended to establish the efficacy and toxicity of~     treating unresectable colorectal liver metastases with accurately administered radiation~     using the CyberKnife stereotactic radiosurgery system.~   "
171660|NCT01318434|"~     The main research hypothesis for this study is that, among patients with Major Depressive~     Disorder (MDD) who have responded inadequately to treatment with SSRIs or SNRIs, the degree~     of improvement, as measured by the change from baseline of the Montgomery-Asberg Depression~     Rating Scale (MADRS)will be significantly greater among patients treated with EB-1010 (at the~     dose of 50 mg/day or 100 mg/day) than among those treated with placebo using the sequential~     parallel comparison design. The secondary research hypothesis for this study is that, among~     patients with MDD who have responded inadequately to treatment with SSRIs or SNRIs, the~     degree of improvement in depressive symptoms, as assessed by the MGH Cognitive and Physical~     Functioning Questionnaire (MGH CPFQ) will be significantly greater among those treated with~     EB-1010 (50 mg/day or 100 mg/day) than those treated with the SSRI paroxetine.~   "
171661|NCT01318421|"~     The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in~     patients with multiple sclerosis (MS) after participation in study MS103.~   "
171662|NCT01318408|"~     Elderly persons with dementia are at risk for seizures, however, traditional anticonvulsants~     are poorly tolerated in this population. Our goal is to examine Levetiracetam (Keppra) in~     elderly dementia patients with seizures. While it has been established that Keppra controls~     seizures in this age group, it is important to demonstrate that treatment with Keppra would~     not affect cognitive abilities in this large population of patients . As this population is~     already cognitively impaired, the best choice of anticonvulsant would be one that does not~     further compromise their cognitive abilities. Keppra is an excellent anticonvulsant agent in~     the elderly for a variety of reasons, including safety, favorable side effect profile, lack~     of interaction with other drugs, and efficacy. Our retrospective pilot data suggests that~     cognition is not negatively affected by Keppra. The current prospective study will assess the~     cognitive abilities of persons with cognitive impairment at baseline and at weeks 4 and 12.~     The overall objective is to determine the cognitive tolerability of Keppra for seizures in~     elderly cognitively impaired patients.~   "
171663|NCT01318395|"~     Hypertension affects approximately one fourth of the world population and therefore~     contributes substantially to the worldwide burden of cardiovascular (CV) disease and~     end-organ damage.~      Changes in small artery structure characterized by an increased wall-to-lumen ratio (WLR) are~     characteristic feature of target organ damage in hypertension. Of clinical importance,~     structural arteries of small subcutaneous arteries have been shown to be of prognostic~     significance, with adverse prognosis in subjects with higher WLR. However, the assessment of~     arteriolar structure from biopsies of subcutaneous tissue is invasive and impractical in~     clinical practice. A new approach focuses on retinal arteriolar structural parameters by~     using scanning laser Doppler flowmetry (SLDF) with automatic full-field perfusion imaging~     analyses (9). This approach allows the non-invasive assessment of both the outer diameter~     (OD) and inner diameter (ID) of retinal arterioles in vivo and, thus, analyses vascular~     remodeling of retinal arterioles by calculating WLR = (OD - ID) / ID).~      A crucial role in the efforts of prevention of end-organ damage plays the renin angiotensin~     system (RAS). The increased mechanical strain on the vasculature at a higher BP can cause~     injury to the endothelial wall. Activation of the RAS increases BP and stimulates a local~     inflammatory response to repair the injury. Long-term or repeated response to injury leads to~     endothelial dysfunction and microvascular damage, and hence end-organ damage.~      Combining RAS inhibitors may provide greater end-organ protection than use of either class~     alone. However, ONTARGET has failed to show superiority of the dual RAS blockade (ACE-I and~     ARB) in patients at high cardiovascular risk. The combination of ARBs and direct renin~     inhibitors (DRIs) emerged as the only available, valid and innovative option for blocking the~     RAS at two different sites (sequential blockade). Indeed, AVOID study and ALLAY study~     demonstrated that the DRI aliskiren has additional and to some extent blood pressure~     independent effects on albuminuria and left ventricular hypertrophy, both signs of~     subclinical organ damage in hypertension, respectively.~      However, no data are available with respect to the effects of ARBs and DRIs on vascular~     properties in the short and long term To close this gab we focus in this study on vascular~     structural and functional changes since vascular adaptation to high blood pressure occurs in~     the early phase of hypertensive disease.~   "
171664|NCT01318382|"~     This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios~     at tracheal extubation when anesthesiologists have determined that full recovery of~     neuromuscular function has occurred using standard clinical criteria for participants whose~     non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase~     inhibitor administered as per standard routine care.~   "
171665|NCT01318369|"~     The main goal of this trial is to study the efficacy of Namisol® after a single dose of~     Δ9-THC in the treatment of pain resulting from chronic pancreatitis. Objective measures of~     pain processing, e.g. encephalography (EEG) and quantitative sensory testing (QST), are~     included to provide insight in underlying nociceptive processing.~   "
171666|NCT01318356|"~     The objective of this study is to assess the efficacy of two treatment strategies for fatigue~     and disabilities in QFS: long term treatment with doxycycline or cognitive behavioral therapy~     (CBT).~   "
171667|NCT01318343|"~     The purpose of this study is to evaluate the safety and efficacy of single treatment vs.~     multiple treatments of CoolSculpting™ by Zeltiq™ Aesthetics for non-invasive cooling of~     subcutaneous fat using the eZ App 8 large applicator on the abdomen for fat layer reduction.~   "
171668|NCT01318330|"~     Official Title: Five-Week, Multi-center, Phase I Clinical Trial to Evaluate Safety of~     Homeo-GH after Intra Venus Administration for the Treatment of Graft versus Host Disease~     Patients~      Sponsor: HomeoTherapy Co.,Ltd~      Study Design: Single Group, Open Label, 5 Week, Safety Study~      This study is designed to evaluate the safety of ex-vivo cultured adult human clonal~     mesenchymal stem cells (cMSC) derived from human bone marrow in subjects experiencing acute~     or chronic graft-versus-host disease (GVHD).~      Study Type: Interventional~   "
171669|NCT01318317|"~     This phase I/II trial studies the side effects and best dose of genetically engineered~     lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant~     (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma~     (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different~     ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a~     PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving~     colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move~     from the bone marrow to the blood so they can be collected and stored. More chemotherapy or~     radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem~     cells are then returned to the patient to replace the blood-forming cells that were destroyed~     by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an~     effective treatment for NHL~   "
171670|NCT01318304|"~     The innate immunity of the vaginal tract provides first-line defense from abnormal~     microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella~     vaginalis. It is unclear from the current available literature whether the rate of vaginal~     infection increases or decreases in frequency during pregnancy when compared to the~     non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal~     infections are important players in HIV disease, potentially increasing the risk of viral~     transmission. In addition, these infections may activate inflammatory markers in the~     reproductive tract and increase the risk of premature delivery or other negative pregnancy~     outcomes. The vaginal innate immune system has not been well characterized in pregnant women,~     or in women with HIV infection. The study of how this system changes in pregnancy and HIV~     infection will provide essential knowledge for further study of vaginal mucosal protection.~      The investigators study is an observational study designed to compare levels of vaginal~     innate immunity markers in women based on a) pregnancy status and b) HIV infection status.~     Comparisons will be made between pregnant and non- pregnant women and between HIV positive~     and HIV negative women. The investigators hypothesize that there will be significant~     differences in levels of innate immunity between the groups.~   "
171671|NCT01318291|"~     The most common reason why insured In Vitro Fertilization (IVF) patients drop out of~     treatment is the distress caused by the treatment.~      The objective of this study is to determine the efficacy of a combined Cognitive Coping and~     Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.~   "
171688|NCT01318070|"~     The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily~     (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled~     blood glucose.~   "
171700|NCT01317914|"~     Direct benefits to the participants, who are diagnosed with celiac disease may be substantial~     and could include lessening or prevention of GI symptoms, correction of biochemical~     abnormalities and reduction in risk for malignancies or bone disease which are most common in~     untreated celiac disease. However, the precise benefit is unknown and the motivation for this~     proposed study. If these individuals have a positive celiac serology test at the present time~     there is a high likelihood that they may have celiac disease.~   "
171672|NCT01318278|"~     Low blood pressure or hypotension is a very important problem that is often seen in premature~     babies, especially those with low birth weight. Severe hypotension leads to significant~     problems including brain bleeds, developmental delays, kidney and liver problems, and other~     issues that can affect babies for the rest of their lives. An important aspect in the~     management of infants with hypotension is the decision of when to treat and with what agent.~     Research is being conducted to try to find the best medication to use in these situations.~     Dopamine is often used first, but it does not always prove to be effective, and it has~     several concerning side effects. This study will look at vasopressin, which has fewer side~     effects, as a first-line medication for low blood pressure in extremely low birth weight~     infants.~      Hypotheses and Specific Aims: This study will show superiority of vasopressin to dopamine in~     preterm, extremely low birth weight infants who have hypotension within the first 24 hours of~     life. We will specifically look at its ability to raise blood pressure values, improve~     clinical symptoms seen, any adverse effects, and clinical outcomes of babies being treated.~   "
171673|NCT01318265|"~     The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the~     pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.~   "
171674|NCT01318252|"~     The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared~     with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular~     hypertension.~   "
171675|NCT01318239|"~     The purpose of our study is to establish the accuracy of the perfusion MRI parameters and the~     availability of the VEGFR2 signaling assay using phosphospecific flow cytometry in predicting~     the response of liver metastasis from colorectal cancer to treatment with antiangiogenic~     agent.~   "
171676|NCT01318226|"~     This is a Phase 2 randomized, double-blind, placebo-controlled, multiple-dose, multicenter,~     parallel-group study to evaluate the analgesic activity of ATx08-001, a novel selective~     peroxisome proliferator-activated receptor modulator (SPPARM), in subjects with~     moderate-to-severe postherpetic neuralgia pain. Eligible subjects will be randomized to~     receive either placebo or Atx08-001. Study drug will be administered orally twice a day for 7~     days. Subjects will be evaluated for neuropathic pain intensity at regular intervals over a 6~     hour period on Day 1 following the first dose of study drug. They will then be discharged~     from the clinic and will complete diary assessments of pain severity twice a day at home.~     Subjects will be asked to return to the clinic on Day 8 to complete their last set of pain~     evaluations.~   "
171677|NCT01318213|"~     This study will test if doctors, nurses and other people who take care of patients in~     hospitals wearing gloves and gown for all contact with patients in an intensive care unit~     (ICU) will:~        -  Decrease the chance of patients getting an infection while in the hospital~        -  Decrease the chance of patients picking up bacteria as a result of being in the hospital~        -  Decrease the time a patient spends in the ICU or in the hospital~        -  Increase the frequency of adverse events~      The study will also look at whether making doctors, nurses and other people who take care of~     patients wear gloves and gown for all contact with patients will decrease the amount of time~     healthcare workers spend with patients.~      This study will gather information by comparing what happens in ICUs that continue to do what~     they were doing before the study with what happens in ICUs that require healthcare workers to~     wear gloves and gown for all contact with patients.~      This study will provide information that will help to make being in the hospital safer for~     all patients.~   "
171678|NCT01318200|"~     To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic~     body radiotherapy in the treatment of patients with locally recurrent hepatocellular~     carcinoma (HCC) after TACE.~   "
171679|NCT01318187|"~     STUDY OBJECTIVE: This randomized, controlled trial evaluates the analgesic efficacy and~     safety of intravenous single-dose paracetamol and morphine for the treatment of acute flank~     pain.~      METHODS: The investigators conducted a randomized, double-blind, controlled clinical trial~     comparing single intravenous doses of paracetamol (1 g) and morphine (0.1 mg/kg) for patients~     presenting to the emergency department (ED) with acute flank pain. Subjects with inadequate~     pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg).~   "
171680|NCT01318174|"~     The purpose of this study is to determine the prevalence of pulmonary embolism in our~     population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with~     dyspnea. The patients will undergo investigation for pulmonary embolism, according to current~     guidelines.~   "
171681|NCT01318161|"~     Colorectal cancer is one of the most common cancers in the industrialized world (12% of all~     cancers). In Sweden, 6000 new cases of colorectal cancer are reported each year, and almost~     half of these cases result in death. Several recently published retrospective studies show~     that regional anaesthesia (RA) can reduce cancer-related mortality following surgical~     treatment of colorectal, breast and prostate cancers and malignant melanoma. If these results~     are true, then the choice of perioperative pain management is as beneficial, or even better,~     than the current oncological therapies. This theory needs to be investigated in a~     prospective, randomized and controlled trail.~   "
171682|NCT01318148|"~     The study is a pilot phase II, prospective, non-comparative, single center trial aimed to~     evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal~     prophylaxis in high risk patients.~   "
171683|NCT01318135|"~     To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea~     (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).~   "
171684|NCT01318122|"~     The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and~     Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who~     completed a phase 2/3 Thiazolidine add on study.~   "
171685|NCT01318109|"~     The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD)~     combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic~     patients with uncontrolled blood glucose.~   "
171686|NCT01318096|"~     In this pilot study, the investigators would examine the safety and efficacy of integrase~     inhibitor-Raltegravir in the control of HIV/HBV co-infection.~   "
171687|NCT01318083|"~     The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD)~     combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with~     uncontrolled blood glucose.~   "
171689|NCT01318057|"~     Warfarin (Coumadin) is a prescribed blood thinner medication used to make the blood less~     thick in people with high risk of forming blood clots. Despite the various methods to monitor~     this drug, life-threatening bleeding is a common undesired effect and might result in patient~     death. Patients starting warfarin therapy may require several weeks or even months to reach~     the appropriate blood level of warfarin. This blind practice could place the patient at high~     risk. There are several demographic and clinical factors that significantly influence how~     much warfarin the patient needs to attain the desired response. Genes, which control~     hereditary traits, are also important. Now, the investigators know that by using the~     information encoded in patient's genes the investigators are able to individualize the~     therapy. Two genes are considered to be involved in warfarin response (CYP2C9 and VKORC1).~     This study proposes to ascertain what CYP2C9 and VKORC1 variants are present in~     warfarin-treated Puerto Rican patients. To this purpose, a novel physiogenomic array~     comprising 384 variants in 222 genes of cardio-metabolic relevance will be used so the~     investigators are able to determine the structure of the Puerto Rican population in terms of~     ancestral contributions and how the admixture may impact the prevalence of CYP2C9 and VKORC1~     variants. Secondly, the investigators will assess the association of these variants to~     clinical responses in order to develop a better method of dose estimation. The expected~     result is the improvement of warfarin therapy in Puerto Ricans. The proposed study will fill~     a gap in the knowledge of warfarin pharmacogenetics, providing new information on the~     prevalence of CYP2C9 (metabolism) and VKORC1 (sensitivity) polymorphisms in Puerto Ricans as~     well as their role in the warfarin response variability observed in this admixed population.~   "
171690|NCT01318044|"~     Magnetic resonance imagining (MRI) in children requires sedation to achieve the degree of~     cooperation or immobilization, necessary to complete these procedures successfully. In this~     study the investigators analyze two most popular anesthetics used for this procedure, sodium~     thiopental and propofol. The aim of this study is to determine optimal dose of propofol and~     thiopental during MRI and to establish safety and efficacy of these drugs.~   "
171691|NCT01318031|"~     Study of a drug drug interaction between Paroxetine and PF-00299804.~   "
171692|NCT01318018|"~     Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients~     suffering from depression, who do not respond to medical treatment. However it is often~     dismissed by patients, who feel uncomfortably about the application of electric shocks to~     their heads. In 2000, magnetic seizure therapy (MST) has been introduced which uses magnetism~     instead of electricity to evoke convulsions. MST seems to be as effective as ECT in terms of~     its antidepressant potency but may be associated with less severe cognitive side effects.~      Control of anaesthesia during seizure therapy is demanding since light anesthesia might be~     associated with awareness, whereas deep anesthesia impedes the antidepressant effect of the~     convulsion. Therefore, Bispectral index (BIS) monitoring is frequently used to tailor~     anaesthesia for ECT, however little is known about BIS following MST.~      The investigators hypothesize that in comparing MST with ECT, (a) patients show a faster~     increase in BIS and that (b)less left-right differences occur in BIS.~   "
171693|NCT01318005|"~     The purpose of this research study is to gain a better understanding of the changes that may~     occur in the breast when a woman uses an oral contraceptive (birth control pill). Some~     research indicates that women who use birth control pills with lower amounts of estrogen (a~     hormone in the birth control pill) may have lower breast cell growth than women who use birth~     control pills with a higher amount of estrogen; this research will examine that in detail.~     This research will also test whether the results found in HS-07-00269 can be confirmed.~   "
171694|NCT01317992|"~     The purpose of this study is to determine if ibudilast is effective in reverting patients~     with medication overuse headache suffering chronic daily headache back to their original~     episodic headache pattern.~   "
171695|NCT01317979|"~     Type 2 Diabetes Mellitus (T2DM) is a serious health problem that has increased dramatically~     worldwide due to the high and increasing prevalence of obesity. Medical management of T2DM is~     of limited success. Because not well controlled T2DM patients are in high risk of blindness,~     cardiovascular accident and end staged disease, T2DM has become a major health burden for~     society. Recent data on the relative effectiveness of gastrointestinal metabolic surgery~     played as bariatric surgery in the remission of T2DM, suggests that it may be significantly~     more effective than current medical treatment. In considering that less than half of the T2DM~     patients can achieve satisfactory treatment goal under current medical treatment,~     gastrointestinal metabolic surgery shall play an important role in T2DM treatment in the~     future. However, the indication for metabolic surgery and clinical predictors of success are~     not clear now. These clinical predictors can help us to choose appropriate not-well~     controlled T2DM patients to receive metabolic surgery and reduce dverse health outcomes in~     those patients.~   "
171696|NCT01317966|"~     The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11)~     Combination Low-dose Rituximab prednisone are effective and safe in the management of~     Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).~   "
171697|NCT01317953|"~     The purpose of this study is to determine whether green tea extract is safe for~     extensive-stage small lung cancer who achieved objective tumor response after first-line~     therapy.~   "
171698|NCT01317940|"~     Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone~     density by the end of treatment. This can lead to long-term suffering in survivors due to~     poor bone health. Vitamin D is known to be associated with bone health and previous research~     has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens~     over the course of treatment. Researchers have also learned that a relationship exists~     between both Vitamin D and fat tissue and ALL and fat tissue.~      In adolescents being treated for ALL as well as in early survivors, this randomized study~     will therefore examine the effect of Vitamin D and calcium supplementation on correcting~     Vitamin D insufficiency and on improving bone density in the context of changes in body~     composition and body fat. Bone density will be measured by a radiology exam called a~     quantitative computed tomography (or qCT) while body composition and body fat will be~     measured by a different radiology exam called a dual energy x-ray absorptiometry (or DEXA~     scan). The study will also examine in depth the relationship between these three elements -~     Vitamin D insufficiency, obesity, and ALL - and their impact on bone density.~   "
171699|NCT01317927|"~     The purpose of this study is to evaluate the plasma concentration and pharmacodynamics~     effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m².~      Pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of~     warfarin 5 mg.~   "
171745|NCT01317329|"~     The purpose of this study is to determine the factors that are associated with improved~     cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to~     severe obstructive sleep apnea.~   "
171701|NCT01317901|"~     This was a Phase 1 multicenter study of bendamustine, rituximab and TRU-016 (BRT) in subjects~     with relapsed indolent B-cell lymphoma. This was a multiple-dose escalation study to~     determine the maximum-tolerated dose (MTD) of TRU-016 given in combination with rituximab and~     bendamustine and to determine a safe dosing regimen for the combination in up to 12 subjects~     with relapsed indolent lymphoma.~      The originally planned Phase 2 portion, an open-label, randomized study to evaluate the~     efficacy of BRT compared with BR, was not conducted.~   "
171702|NCT01317888|"~     The purpose of this access protocol is to allow patients with brain tumors who had previously~     received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor~     begins to grow, they develop side effects to the treatment, or their medical condition~     changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV)~     or develop another cancer).~   "
171703|NCT01317875|"~     This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib~     in patients with myelofibrosis (MF). The study consists of two periods: the core study~     period, comprising the dose escalation stage and the safety extension phase up to Week 24,~     then the extension study period beyond Week 24 and up to 3 years, to further characterize the~     safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will~     enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the~     maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional~     patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The~     primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting~     platelet counts < 100 x 10 ^9/L~   "
171704|NCT01317862|"~     The purpose of this study is to assess the effectiveness and safety of transcervical foley~     catheter as compared to prostaglandins for preinduction cervical ripening and labor induction~     in term nulliparous women with unfavorable cervix.~   "
171705|NCT01317849|"~     The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary~     stroke prevention trial in China to determine whether the addition of folic acid and vitamin~     supplements will reduce recurrent stroke events and other combined incidence of recurrent~     vascular events and vascular death.~   "
171706|NCT01317836|"~     Preoperative diagnosis of pancreatic cystic lesions remains a difficult problem in clinical~     practice. At present, the treatment planning in pancreatic cystic neoplasms is significantly~     restricted by the limited preoperative diagnosis. Ultrasonography (US), multidetector~     computed tomography (MDCT) and magnetic resonance imaging (MRI) are the conventional~     modalities in imaging of pancreatic cystic neoplasms, but by these methods the diagnostic~     accuracy still remains compromised. Furthermore, recently encouraging results have been~     obtained in pancreatic cystic neoplasms using 18F-fluoro-2-deoxyglucose positron emission~     tomography (18F-FDG-PET) The aim of the current project is to evaluate the possibility to~     enhance the diagnostic accuracy by using the combined 18F-FDG-PET-CT imaging in patients with~     pancreatic cystic neoplasms by combining PET-CT with MRI and MDCT.~   "
171707|NCT01317823|"~     To compare the ultrasonographic cervical length with the Bishop score in determining the~     administration of prostaglandin for preinduction cervical ripening in multiparous women at~     term.~   "
171708|NCT01317810|"~     The purpose of this study is to track changes in overactive bladder (OAB) medical regimen~     and/or OAB medication dosage requirements.~   "
171709|NCT01317797|"~     The purpose of this trial is primarily to investigate the safety and tolerability of repeated~     subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.~     Furthermore, the amount of MT203 in the blood will be measured and it will be investigated~     how the body responds to MT203 treatment and if MT203 is effective in the treatment of~     rheumatoid arthritis.~   "
171710|NCT01317784|"~     The relevance of this research to public health is to make it possible to test for hepatitis~     C and syphilis at point of care so that people will receive their results immediately instead~     of requiring people to wait for at least a week to get their test results. This research will~     make rapid tests for HIV available that can detect HIV infection earlier and are more~     accurate than current tests available in the United States.~   "
171711|NCT01317771|"~     Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis~     with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to~     participate in the study. The study will assess the tendon healing to bone through magnetic~     resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS)~     pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for~     our objective will include age, hand dominance, gender and chronicity of symptoms prior to~     surgery, and other related surgical procedures.~   "
171712|NCT01317758|"~     Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old,~     inclusive, will be enrolled over a 5-month period into this multicenter, randomized,~     double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study~     and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted~     vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular~     subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given~     with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2~     doses separated by approximately 21 days.~   "
171713|NCT01317745|"~     Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old,~     inclusive, will be enrolled over a 5-month period into this multicenter, randomized,~     double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study~     and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted~     vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular~     subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given~     with the adjuvant MF59 or diluent (N=216, up to 270). All eligible subjects will receive 2~     doses separated by approximately 21 days.~   "
171766|NCT01317030|"~     The objective of this study is to evaluate tears between habitual contact lens wearers and~     non contact lens wearers using a Schirmer Strip for tear collection.~   "
172189|NCT01311362|"~     The aim of the present study is to assess the impact of CYP3A4-induction by SJW on steady~     state ambrisentan and the impact of the cytochrome P450 2C19 (CYP2C19) genotype (*2 and *3~     allele vs. wild type; ~2-5% poor metabolisers in Caucasian population) on the~     pharmacokinetics of ambrisentan in healthy volunteers.~   "
171714|NCT01317732|"~     In this study we propose 1) to develop a new multisensor monitoring system associating a~     tri-axial accelerometer and a magnetometer to measure physical activity in free-living~     adults, 2) to perform its calibration and assess its validity in a series of activity tasks~     in comparison with the measure of energy expenditure by indirect calorimetry as the criterion~     measure, and with existing physical activity monitors (cardiofrequencemetry and~     accelerometers used either alone or in combination). Briefly the subjects will perform a~     series of standardized activity tasks of different intensities and a 30-min free physical~     activity period while wearing 6 MOTIONPOD(TM) and different commercial activity monitors.~     Physical activity energy expenditure will be measured using a metabolic gas analyser.~      Data of the 30 first subjects will be used to develop new algorithms to identify the~     different activity tasks and to estimate the related energy expenditures. Data of the~     following 30 subjects will be used to validate the MotionPOD(TM) against indirect calorimetry~     and existing physical activity monitors~   "
171715|NCT01317719|"~     The primary goal of this study is to determine if surgical repair of the distal biceps fully~     restores the supination strength of the forearm. Secondarily, the investigators want to~     examine the insertion site location of the tendon and determine if it correlates with the~     patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand~     (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.~   "
171716|NCT01317706|"~     To compare the ultrasonographic cervical length with the Bishop score in determining the~     administration of prostaglandin for preinduction cervical ripening in nulliparas at term.~   "
171717|NCT01317693|"~     Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile~     tissue. Shockwaves are created by a special generator and are focused using a specially~     designed shockwave applicator apparatus. The shockwaves are delivered through the applicator~     covering the corpora cavernosa of the penis. In previous studies the investigators used a~     medium focused probe and in this study the investigators are evaluating results of this~     therapy using a wider focus probe in the aim of improving results of treatment.~   "
171718|NCT01317680|"~     Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of~     new blood vessels. The investigators hypothesized that LISW therapy could improve the~     symptoms of patients with erectile dysfunction resulting from a problem of blood supply~     (damage that can occur after radical prostatectomy in addition to neural damage or solely)~     that do not respond to oral therapy (PDE-5 inhibitors).~   "
171719|NCT01317667|"~     This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the~     safety and immunogenicity of the RVEc vaccine.~      The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety~     profile as determined by adverse event data and RVEc vaccine will elicit ELISA immunoglobulin~     G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody (TNA)~     anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine~     recipients.~   "
171720|NCT01317654|"~     All patients who were alive at the end of the dexamethasone treatment trial conducted by~     Oxford University CLinical Research Unit from 2001-2005 (n=340) will be eligible to~     participate in this long-term follow-up study.~      All eligible and consenting patients will undergo an assesment consisting of a simple~     questionnaire, a clinical examination and a blood test. Data collected will focus on~     survival, neurological disability and tuberculosis relapse. Data will be collected in~     individual case record forms and entered into a computer database.~   "
171721|NCT01317641|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201~     in patients with castrate resistant prostate cancer.~   "
171722|NCT01317628|"~     Researchers have noted that active smoke exposure was possibly related to epigenetic~     mechanism,and may further influence reactive immunotoxicological reaction on human beings.~     Some studies have been reported that smoking reduction would decrease the prevalence of~     respiratory symptoms and urinary cotinine level, but the underlying epigenetic mechanism and~     the functional changes of immunotoxicological system were still unclear. We plan to examine~     the causal relationship between smoking reduction and alterations in epigenetic~     signatures/immunotoxicological reactions. Teenager Smoking Reduction Trial (TSRT) will be~     population-based trial among teenagers. Eligible teenagers will be recruited in Taipei City~     and urinary cotinine level will be used to monitor the exposure status of active smoking at~     baseline, 1-month and 3-month of the intervention process. We will assess the potential~     change in immunotoxicological markers, including Th1/Th2 cytokines and clinical immunological~     measurements, before and after the intervention program. Furthermore, whole-genome~     methylation and miRNA expression microarrays will be used to search candidate genes for~     teenager smoking exposure. We plan to develop a prediction model for immunotoxicological~     reaction by utilizing epigenetic signature data from microRNA expression and DNA methylation~     profiles based on machine learning methodologies. We will also establish a personalized~     epigenetic prediction model for allergy development and build the risk assessment platform~     for immunotoxicological reaction under tobacco smoke exposure. Finally, we will examine the~     causal relationship between epigenetic signatures and immunotoxicological reactions under an~     independent children's cohort.~   "
171723|NCT01317615|"~     This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in~     patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine~     differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.~   "
171724|NCT01317602|"~     This is a multicenter, 1-year prospective, observational study of Atrial Fibrillation (AF) in~     Greece, designed to provide real world data regarding the characteristics of AF patients in~     Greece, as well as current clinical practices and adherence to the 2010 ESC guidelines.~   "
171767|NCT01317017|"~     IFN-gamma is a central player in the development of psoriasis lesions, which can be involved~     a variety of cellular processes in the skin. Dendritic cells are important cells in driving~     inflammation in psoriasis through the induction of T cells that produce IL-17 in psoriasis.~     Injecting IFN-g into the skin can increase the numbers of T cells and also inflammatory DCs~     that produce cytokines involved in IL-17 production. Thus, the investigators hypothesize that~     the dendritic cells present in the skin after IFN-g injection polarize IL-17-producing T~     cells.~   "
172190|NCT01311349|"~     Various bacterial organisms will be tested in order to compile information regarding the~     effectiveness of tigecycline against certain bacteria seen in local communities.~   "
171725|NCT01317589|"~     Background of the study:~      Treatment of Pain in Head-and-Neck Cancer Patients:~      is methadone more effective than fentanyl?~      Pain is a prevalent symptom in patients with cancer. A neuropathic component is seen in one~     third of the patients. In patients with head-and-neck cancer neuropathic pain is far more~     prevalent than in a general cancer population: 46-64%. Treatment of neuropathic pain is~     complex and available treatment modalities achieve (partial) pain relief in only 40-60% of~     patients. The N-Methyl-D-Aspartate Receptor (NMDAR) plays a central role in the mediation of~     neuropathic pain. NMDAR blockers could be a new approach to treat neuropathic pain in~     patients with cancer.~      Methadone is a strong opioid but at the same time significant non-competitive NMDA-receptor~     antagonist qualities have been described. Many small studies and case-reports describe the~     successful rotation from different strong opioids to methadone. There are no studies that~     selected patients with (predominantly) neuropathic pain to be treated with methadone, whereas~     this group of patients is expected to profit from the NMDAR-antagonist properties of~     methadone.~      Objective of the study:~      This randomised controlled trial (RCT) aims to investigate whether addition of a~     NMDAR-antagonist to a strong opioid (methadone) is superior in the treatment of predominantly~     neuropathic pain over a strong opioid alone (fentanyl) in terms of pain relief and time to~     achieve significant pain relief.~      Study design:~      Open label randomised controlled trial~      Study population:~      opioid naïve patients with histological proven head-and-neck cancer and (partly) neuropathic~     pain with a NRS score of ≥ 4, age =/> 18 years~      Intervention Treatment with methadone or fentanyl patch~      Primary study parameters/outcome of the study:~      Is methadone more effective than fentanyl in the treatment of pain in patients with~     head-and-neck cancer with respect to~        1. significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) and~        2. pain interference~      Secondary study parameters/outcome of the study:~      Is methadone superior to fentanyl in the treatment of pain in patients with head-and-neck~     cancer with respect to~        1. time to achieve significant pain relief~        2. side-effect profile?~   "
171726|NCT01317576|"~     Due to the western lifestyle, correlated with a high calorie intake and low physical~     activity, obesity is becoming a major health problem. All over the world obesity reaches~     epidemic proportions. Obesity is closely linked to type 2 diabetes, a multi-factorial disease~     that increases the presence of multiple health problems. Until now, exercise and dietary~     intervention seem to be the single most effective interventions to treat obesity and type 2~     diabetes mellitus. In obesity and type 2 diabetes, not only fat accumulation in adipose~     tissue, but also fat accumulation in the peripheral tissues occurs. Fat accumulation in~     peripheral tissues has been associated with insulin resistance. Exercise seems to have a~     positive effect on the accumulation of fat in the peripheral tissue and on the insulin~     sensitivity in type 2 diabetic patients.~      In this study we want to investigate if a prolonged exercise training program can lower the~     intrahepatic lipid content and can improve the metabolism of the liver in type 2 diabetic~     patients and patients with non-alcoholic fatty liver disease, and to examine if this leads to~     improvements in metabolic risk markers. To this end, we will include investigation of the~     effect of exercise on adipose tissue (inflammatory markers and adipocyte size) and skeletal~     muscle (ex vivo lipid metabolism) to incorporate the effect of exercise on liver, muscle and~     adipose tissue and to clarify the crosstalk between these tissues in the pathophysiology of~     type 2 diabetes.~   "
171727|NCT01317563|"~     This project will assess the effectiveness of antioxidant supplementation with common~     vitamins A, C, E and selenium in controlling asthma symptoms among lean and obese asthmatics.~     This project may improve our ability to treat asthma and our understanding of the link~     between nutritional antioxidants and asthma.~   "
171728|NCT01317550|"~     The goal of this clinical research study is to compare armodafinil and minocycline when given~     alone or in combination to learn which is better for controlling symptoms, such as the side~     effects of chemoradiation, when given to treat lung cancer.~   "
171729|NCT01317537|"~     Project Summary:~      An electronic personal health record (ePHR) could maximize patient/clinician collaboration~     and consequently improve patient self-management and related health outcomes. The purpose of~     the proposed project is to examine the feasibility, acceptability, and impact of an ePHR that~     has been modified using a patient- and family-centered approach and incorporates the~     experiences, perspectives, and insights of patients and family members actually using the~     system. Comparison of patients with the ePHR intervention to a group of care as usual~     patients will be performed. The investigators Specific Aims are: (1) To improve the~     application of patient- and family-centered care elements in an existing ePHR, based on~     feedback from a pilot study of patients and their families. The modified ePHR will be tested~     in a pilot group of patients with hypertension and their families. (2) To implement and test~     the effectiveness of the modified ePHR with patients being treated for hypertension by a team~     of physicians, mid-level practitioners, nurse clinicians, and support staff in two ambulatory~     settings. Outcome measures will include patient activation and perception of care,~     quantifiable biological markers, patient-physician communication, and congruence of treatment~     with guidelines, particularly medication management; (3) To monitor the shift in provider and~     support staff awareness and incorporation of patient- and family-centered care as a result of~     implementation of the ePHR using questionnaires and focus groups. If successful, this ePHR~     could be implemented in additional locations in the Southeast.~   "
171730|NCT01317524|"~     The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed~     milk on postprandial metabolism in healthy overweight men~   "
171731|NCT01317511|"~     Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase~     mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to~     provide further insight into the responsiveness of the muscle protein synthetic machinery to~     food intake in relation to age.~   "
171732|NCT01317498|"~     The purpose of the study is to test the hypothesis that the addition of routine viral load~     testing to the standard laboratory monitoring of HIV patients on first-line antiretroviral~     treatment (ART) in Vietnam will result in better clinical outcomes for patients.~   "
171733|NCT01317485|"~     The first objective (LOLA) of this integrated trial is to determine whether laparoscopic~     lavage leads to better clinical outcomes compared to sigmoidectomy in patients with~     perforated diverticulitis with purulent peritonitis in terms of mortality and major~     morbidity. The second objective (DIVA) is to determine whether sigmoidectomy with anastomosis~     or sigmoidectomy with end-colostomy is the superior approach in patients with perforated~     diverticulitis with either purulent or faecal peritonitis in terms of stoma free survival.~     The study is designed as a multicenter and randomised trial.~   "
171734|NCT01317472|"~     Recent studies have demonstrated that patients with throat-related reflux often require twice~     daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once~     daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump~     inhibitor requiring only once-daily dosing, it may provide LPR symptomatic relief comparable~     to that of twice daily dosing, yet be more readily approved by third party payers because of~     its once daily dosing requirements. It is hypothesized that, in patients with~     pharyngeal-probe proven throat reflux, there will be significantly greater improvement in~     symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those~     receiving placebo alone.~   "
171735|NCT01317459|"~     Background: 50% of people with diabetes are living with too high blood sugars and increased~     risk of diabetes related complications together with poor quality of life. The need to~     improve diabetes care by better enabling patients to utilise their individual and local~     resources to self-manage the condition is widely recognized, yet there is a lack of access to~     evidence-based patient-centred healthcare interventions. At present the individual patient's~     judgement of own concrete situation mostly remains unexplored and insufficiently used in~     decision-making causing that problems perceived by the patient in living with the illness~     remain unrecognised and insufficiently resolved.~      Aim and Methods: Guided self-determination (GSD) is an educational method developed to~     promote patient autonomy, participation, skills building and intrinsic motivation. In this~     evidence-based group-intervention the main objective is to implement and evaluate GSD through~     a randomised controlled trial. GSD methods will be performed seven times for the intervention~     group. The control group will receive traditional out-patient consultations - 'care as usual'~     Outcome measures will be performed at baseline, after 9 and 18 months. The project will focus~     on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective~     in preventing late complications and enhanced psychosocial health. GSD is presumably an~     intervention providing psychosocial support applicable in busy clinical practice.~      An alliance is established between Haukeland University Hospital, Norway and Steno Diabetes~     centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College,~     and Bergen University to conduct this intervention and thus make the best possible use of~     interrelated knowledge within the issue.~   "
171736|NCT01317446|"~     The purpose of this study is to determine whether rinsing with an amine fluoride/stannous~     flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing~     alone.~   "
171737|NCT01317433|"~     The aim of this study is to test the role of cycline in the prevention of acne-like skin rash~     in metastatic colorectal patients treated with Cetuximab and intensified FOLFIRI.~   "
171738|NCT01317420|"~     This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated~     dose (MTD) of a new drug BI 836845 which blocks the insulin growth factor (IGF) pathway~     believed to be involved in cancer growth. BI 836845 will be administered for the very first~     time into cancer patients.~      The study will also look at the overall safety of the drug, and examine the drug levels in~     the body at specific timepoints during the trial (pharmacokinetic profile); the effect the~     drug may have on tumours will also be examined (pharmacodynamics).~   "
171739|NCT01317407|"~     After an operation many patients are in a confused mental status at the intensive care unit.~     In this status they possibly fall out of their bed or pull out endotracheal tubes or central~     venous catheters accidentally. For this, they need permanently monitoring and control through~     intensive care personnel.~      The goal of the VIPSafe project is to develop robust techniques for automated patient~     monitoring, that rely on data from a small number of untethered sensors, which are~     nonetheless flexible enough to cope with a large variety of demands.~   "
171740|NCT01317394|"~     This study is a retrospective research in order to compare and analysis the risk factor,~     clinical manifestation and efficacy of albicans candidemia by pulling medical records. We~     hope that this retrospective research will let us understand the method of treatment and~     prevention of albicans candidemia in order to improve the quality of healthcare.~   "
171741|NCT01317381|"~     ICG- Leberfunktionstest versus neue Biomarker als prognostischer Marker bei~     intensivmedizischen Patienten~   "
171742|NCT01317368|"~     This study is conducted to evaluate different analgesic treatments effect following operation~     where the prostate gland is surgically removed.~      The different treatments the investigators wish to investigate is:~        1. Transversus Abdominis Plane (TAP) block.~           The TAP block is a rather new method, where a local anaesthetic is deposited between the~          two inner abdominal muscles. Between these muscles, the nerves that innervates the~          anterior part of the abdominal wall is situated.~        2. Wound infiltration~           In this method you deposit a local anaesthetic in the edges of the wound.~        3. Placebo~      No active local treatment is given.~      All patients who wish to participate will be allocated to one of three different treatment~     groups.~      Group 1:~      Will receive TAP block with a local anaesthetic and wound infiltration with saline.~      Group 2:~      Will receive wound infiltration with a local anaesthetic and TAP block with saline.~      Group 3:~      Will receive TAP block with saline and wound infiltration with saline.~      Beside this local treatment all patients will be given systemic Paracetamol (tablet) and~     Ibuprofen (tablet).~      In addition all patients will be given a pump containing morphine. The pump is connected to a~     button which the patient can activate when they experience pain. This enables the patient to~     control how much morphine he needs, following the operation.~      The hypothesis is that the TAP block is superior in reducing pain and thereby reducing~     morphine consumption compared to wound infiltration and placebo.~   "
171743|NCT01317355|"~     This study will assess the occurrence of multiple symptoms in cancer patients of 5 German~     university hospitals. Primary goal of the study is to assess the prevalence of multiple~     symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder).~   "
171744|NCT01317342|"~     The purpose of this study is, in a phase II randomized trial, to test a newly developed~     machine perfusion technique of human liver allografts before transplantation.~      Ischemia-reperfusion injury is universal in organ transplantation and leads to varying~     degrees of graft dysfunction. Despite this fact, the preservation method in organ~     transplantation has been left unchanged for many years and remains simple static cold~     storage. Given the scarce donor supply, an increasing number of so called marginal or~     extended criteria donor organs have been used for liver transplantation, grafts which were~     previously rarely considered. In addition, allocation policy has changed in many countries,~     and livers are currently often distributed by the severity of the recipient's disease. As a~     result, transplant candidates present sicker, with higher MELD (Model for end stage liver~     disease) scores, at the time of transplant,and the risk of graft dysfunction or even failure~     due to reperfusion injury is high after the use of marginal livers in sick recipients.~      Machine liver perfusion techniques have been significantly improved during the past decade to~     decrease reperfusion injury, and a number of promising results show beneficial effects in~     various animal transplant models by either normothermic or hypothermic oxygenated continuous~     liver perfusion. These techniques generally require machine liver perfusion immediately after~     organ procurement. However, continuous perfusion has several drawbacks, including major~     logistic efforts and risk of organ damage during perfusion and transport.~      Our group, therefore, focused on the practicability of machine liver perfusion. We developed~     an endischemic hypothermic oxygenated perfusion (HOPE) concept through the portal vein only.~     This technique can be easily applied in the operation room shortly before transplantation of~     the recipient, thus after organ transport and back table preparation.~      Recently, the beneficial effect of a similar approach has been confirmed in human liver~     grafts by a phase I non randomized trial. These results prove feasibility and safety of an~     endischemic hypothermic machine perfusion approach and warrant further randomized studies.~   "
171746|NCT01317316|"~     Patients with work-related eye injuries (WREI) admitted to the center in the four-year period~     were enrolled in this prospective study. Institutional Review Board approval was obtained~     before commencement of the study. A special data recording system was developed for the~     study. The study sample comprised only the casualties occurred at workplace and while working~     de facto. The data were abstracted via face to face contact in the emergency department (ED).~     The data sheets comprised sociodemographic and injury-related information brought together in~     15-item questionnaire. Causes of occupational injuries as reported by the victims were~     assigned to either of two groups: Worker-related causes and workplace-related causes.~      Since workers are known to be pressured by the workplace to work in unsafe ways, an isolated~     room in the ED was used for this purpose in order to prevent bias and the patients were not~     accompanied by any person other than the medical personnel in charge of due medical care. The~     patients were also assured that the information obtained by the survey are to be used for~     research purposes only and no feedback is to be given to employers or related persons.~      Patients who did not give consent for the study, fatal accidents and patients younger than 15~     years of age were excluded from the analysis.~   "
171747|NCT01317303|"~     Neuroplasticity refers to the ability of the nerve cells to modify their structure or~     function in response to injury or insult, or other environmental stimuli, with these changes~     outlasting the period of exposure. Plasticity may be observed as short term or long term~     changes. In humans, neuroplasticity can be readily assessed in the motor cortex, as~     excitability changes are demonstrated in the degree to which peripheral muscles are~     activated, seen through changes in motor-evoked potentials (MEPs). In this study, a number of~     approaches to assessing neuroplasticity will be evaluated: Paired-associative stimulation~     (PAS), Theta Burst Stimulation (TBS), which is a form of transcranial magnetic stimulation~     (TMS) and protocols that combine these two. In addition, participants will complete a~     computerised 'rotor pursuit task' designed to provide a measure of motor learning.~      The investigators aim to find the most efficacious (defined by greatest number of responders~     and effect size as seen in an increase in MEP amplitude) brain stimulation protocol. The~     investigators will expose the same participants to four excitatory conditioning stimulation~     paradigms, with each session separated by at least a week.~      Our hypotheses include:~      The four conditioning stimulation protocols should increase motor cortical excitability, the~     investigators therefore expect there to be a significant increase in participant MEPs, with a~     positive correlation in the increase ofMEP amplitude of the protocols. The investigators do~     however expect that due to the principles of homeostatic metaplasticity, that the protocols~     preceded by cTBS will show greater MEP change, due to the lowering of the threshold for LTP~     plasticity induction. In addition, the investigators expect that an increase in the motor~     learning manifest by the rotor pursuit task and for there to be a correlation in participants~     between the increase in MEP amplitude and the improvement in time on target (TOT) shown in~     the motor learning task (MLT).~   "
171748|NCT01317290|"~     The objective of this study is to investigate the accumulation of n-3 LC-PUFA (EPA, DPA and~     DHA) in human lipids by oral supplementation of ALA-rich linseed oil. In addition, the~     accumulation of n-3 LC-PUFA is compared between subpopulations of different age, gender and~     physiological conditions (overweight, increased serum total cholesterol).~   "
171749|NCT01317277|"~     Methamphetamine (METH) is a debilitating and frequently abused substance that is often~     comorbid with HIV infection. HIV+ persons with current METH abuse or dependence (HIV+/METH+)~     have several characteristics, in addition to their substance use, that make them particularly~     susceptible to nonadherence to antiretroviral treatment (ART) including elevated rates of~     neurocognitive impairment, co-occurrence of psychiatric disorders, and unstable living~     situations. The investigators propose an intervention development study designed to address~     these potential mechanisms of nonadherence with the following Specific Aims: 1) To further~     develop and refine a personalized, automated, real-time, mobile phone, text messaging~     intervention (iTAB) designed to improve adherence to ART medications among HIV+/METH+~     persons; 2) To evaluate the acceptability and effectiveness of a brief psychoeducation plus~     text messaging intervention (iTAB) as compared to psychoeducation alone (CTRL) for the~     improvement of objectively measured medication adherence among HIV+/METH+ persons; and 3) To~     examine predictors of within-person trajectories of nonadherence using the longitudinal data~     collected over the study. In order to realize these aims, the investigators will leverage the~     infrastructure of two unique UCSD resources increasing likelihood of study success, impact,~     and innovation: 1) the Translational Methamphetamine AIDS Research Center (TMARC), which is a~     NIDA-funded center that focuses on the combined effects of METH and HIV infection, and 2) the~     California Institute for Telecommunications and Information Technology (Calit2), which~     conducts research on state-of-the-art wireless means of health promotion. Initially, the~     investigators will refine the iTAB intervention to ensure that it is user-centered and~     tailored to the needs of HIV+/METH+ persons via focus groups and rapid prototyping. Once~     refined, the proposed iTAB intervention will use text messages that are automated, scalable,~     personalized, interactive, flexible, and motivating. The investigators will assess the~     acceptability and effectiveness of iTAB in improving objectively measured adherence (i.e.,~     MEMS caps) over a 6-week period via a pilot RCT with 40 HIV+/METH+ assigned to the iTAB~     intervention and 20 HIV+/METH+ assigned to a psychoeducational control. Predictors of~     nonadherence including frequency of METH use, neuropsychological impairment, and mood will be~     examined to determine whether iTAB is better able to compensate for these factors associated~     with nonadherence as compared to CTRL. Further refinement to the iTAB intervention will be~     made in order to pursue a large-scale R01 using our tailored intervention.~   "
171750|NCT01317264|"~     The aim of this study is to investigate the potential disease preventive effects of β-glucans~     from oat and barley.~   "
171751|NCT01317251|"~     The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids.~     To do this, a randomized crossover intervention study with 3 14-day periods (control diet,~     milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples will be~     collected before and after each period, and fecal samples will be collected for the last 5~     days in each period.~   "
171752|NCT01317238|"~     The currently available stock of smallpox vaccine would be insufficient in the face of an~     incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are~     urgently needed because previous manufacturing methods using calf lymph are no longer~     acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea~     has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by~     infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,~     and immunogenicity of CJ-50300 in previously vaccinated healthy volunteers~   "
171753|NCT01317225|"~     The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone~     biweekly can reduce the incidence of preterm labor in patients with an episode of threatened~     preterm labor during the current pregnancy.~   "
171768|NCT01317004|"~     The purpose of this study is to evaluate the change in patient-reported treatment~     satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care,~     using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for~     Medication (TSQM-9).~   "
171782|NCT01316822|"~     This is a Phase 1 study during which patients with advanced cancer will receive~     investigational study drug ARRY-382. Patients will receive increasing doses of study drug in~     order to achieve the highest dose of the study drug possible that will not cause unacceptable~     side effects. Patients will be followed to see what side effects and effectiveness the study~     drug has, if any, in treating the cancer. Approximately 50 patients from the US will be~     enrolled in this study.~   "
172191|NCT01311336|"~     The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg~     pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced~     back and leg pain.~   "
171754|NCT01317212|"~     High-grade gliomas are the commonest primary malignant brain tumours in adults, affecting~     approximately 5000 people per year in the UK. Standard treatment comprises a combination of~     surgery, radiotherapy and chemotherapy; however this condition remains incurable and the~     average survival is approximately 18 months from diagnosis. There are a number of reasons for~     this. Firstly these tumours are highly invasive and involve important areas of brain making~     it impossible to remove them surgically or cure them with radiotherapy. In the majority of~     cases the tumour recurs within 2 to 3cm of the original site of tumour removal. Secondly, due~     to the presence of a barrier between the bloodstream and the brain, when drugs designed to~     kill tumour cells (chemotherapy) are given intravenously or orally, they frequently do not~     reach the tumour at a sufficient dose to have a beneficial effect. As the chemotherapy dose~     has to be very high for a sufficient dose to reach the tumour, drug-related side-effects are~     common.~      Laboratory studies demonstrate that glioma tumour cells are sensitive to a number of~     different chemotherapies, including carboplatin. When given intravenously however,~     carboplatin does not reach a sufficient concentration in the tumour to have a beneficial~     effect. However, studies have shown that carboplatin can be infused directly into the brain~     at a concentration that is highly toxic to tumour cells, but not to normal brain tissue.~     Using very small tubes implanted around the tumour, the investigators are able to infuse~     carboplatin reliably and repeatedly into the area where tumours typical recur. In this study,~     the investigators intend to evaluate the safety of this approach and determine the optimal~     dose of carboplatin to administer. It is hoped that this study will also provide evidence of~     improved survival for patients with high-grade glioma.~   "
171755|NCT01317199|"~     This research is being done to test an investigational product called Muscadine Plus in the~     treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or~     brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific~     antigens (PSA) level.~   "
171756|NCT01317186|"~     In chronic kidney disease calcium (Ca) and phosphate (P) metabolism disorders are very common~     and also they are one of the leading causes of morbidity in these population. FGF23 is a~     novel factor that contributes Ca-P disorders. It has been hypothesized that FGF 23 increase~     is mediated by asymmetric dimethylarginine (ADMA). The aim of the study is to evaluate this~     hypothesis.~   "
171757|NCT01317173|"~     Chronic kidney disease is a progressive disorder that has been influenced with many factors.~     Most of the patients has altered Ca P metabolism and these dis orders are the contributing~     factors of the disease progression. It has been recently documented that FGF23 and Klotho are~     the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the impact of~     Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.~   "
171758|NCT01317160|"~     This prospective randomized study aims to determine whether intermittent pneumatic~     compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in~     plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote~     healing of sutured acute Achilles tendon ruptures.~      At two weeks post surgery, the IPC intervention will be ended and both patient groups will be~     immobilized in an orthosis until follow-up at six weeks.~      The endpoint of the first part of the study is VTE events. The primary outcome will be the~     DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by~     two ultrasonographers masked to the treatment allocation. Secondary outcome will be the~     DVT-incidence at 6 weeks.~      1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis~     (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic~     pulmonary embolism detected by computer tomography.~      The endpoint of the second part of the study is tendon healing quantified at 2 weeks by~     microdialysis followed by quantification of markers for tendon repair.~      The endpoint of the third part of the study is the functional outcome of the patients at one~     year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total~     Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and~     EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.~   "
171759|NCT01317147|"~     The morbidly obese frequently present with mood and anxiety disorders, which are often~     treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators~     hypothesized that gastric bypass surgery would decrease the absorption of SRI. The~     investigators also wished to determine whether a reduction in SRI levels would increase the~     likelihood of worsening depressive symptoms.~   "
171760|NCT01317134|"~     The objectives of the current study are to identify and evaluate new prognostic non-invasive~     and serological markers in patients with pulmonary hypertension. The focus will be on~     L-arginine metabolism and to clarify its influence on endothelial function.~   "
171761|NCT01317121|"~     Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and~     First Episode of Schizophrenia~   "
171762|NCT01317108|"~     Chemo-N0 (1993-1998) is the first prospective randomized multicenter trial in N0 BC designed~     to prospectively evaluate the clinical utility of a biomarker. It used uPA/PAI 1 as~     stratification criteria and randomized high-risk patients to chemotherapy versus observation;~     low-risk patients remained without any systemic therapy. The trial was designed to answer two~     principle questions:~        1. Can the reported prognostic impact of uPA and PAI 1 be validated in a prospective~          multicenter therapy trial? Does low uPA/PAI 1 identify those low-risk N0 patients who~          are candidates for being spared necessity and burden of adjuvant chemotherapy?~        2. Do uPA/PAI 1 high-risk patients benefit from adjuvant CMF chemotherapy?~   "
171763|NCT01317095|"~     The investigators are conducting this research to compare two different methods of closure of~     the sternum after cardiac surgery to determine if one method is better than the other. Open~     heart surgery always requires a sternotomy, and at the end of surgery the sternum needs to be~     closed. The sternum can be closed with Stainless Steel Wires or Sternalock rigid sternal~     closure system with equivocal results; however, the outcomes of these two methods have never~     been investigated in a randomized study. Thus, the investigators are conducting this study to~     compare two different methods of closure if one method demonstrates any recovery benefit over~     the other, using randomizing the subjects 1:1 to either rigid fixation with Sternalock or~     stainless steel wire closure. Recover benefit will be measured by postoperative intubation~     time, length of intensive care unit stay, and overall postoperative length of stay~   "
171764|NCT01317082|"~     The primary objective is to test the hypothesis that the use of the Pressure Right device in~     combination with ondansetron and dexamethasone would result in a lower incidence of~     postoperative vomiting (emesis) than the combination of antiemetic therapy alone.~   "
171765|NCT01317069|"~     Through clinical practice, to explore if the application of Fluorouracil implant could~     effectively delay the local tumor recurrence and improvement the postoperative survival time~     in patients with gallbladder cancer and bile duct cancer.~   "
171769|NCT01316991|"~     Investigators are interested in learning how appetite responds after chewing gum.~      In this research study subjects will be asked to eat a lunch meal provided at our Center.~     After eating the lunch meal, subjects will answer questions describing their feelings of~     hunger, thirst and desire to eat every 30 minutes for 3 hours.~      Blood will be drawn throughout the study period to determine how chewing gum impacts certain~     hormones released from your intestine after eating and therefore how they influence your~     appetite. Blood draws will be done every 30 minutes for 3 hours. At only one of the two study~     visits, subjects will chew gum during specific times. One study visit will not include~     chewing gum.~      After three hours, there will be a snack to eat as much as desired followed by one more set~     of questions and blood draw.~      All study visits will take approximately 4 ½ hours.~   "
171770|NCT01316978|"~     This study is designed to assess bioequivalence between one test and two reference~     formulations used for treatment of headaches and temporary relief of pain.~   "
171771|NCT01316965|"~     Postoperative delirium is common in the elderly and is associated with a significant increase~     in mortality, complications, length of hospital stay and admission in long care facility.~     Several interventions have proved their effectiveness to prevent it but their combination~     within a multifaceted intervention needs to be assessed using rigorous methodology based on~     randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program~     on the prevention of postoperative delirium in elderly.~   "
171772|NCT01316952|"~     A cluster of reports of hypersensitivity reactions among patients who switched from~     carvedilol (immediate release formulation, referred to hereafter as carvedilol) to carvedilol~     extended release was received during the initial post-launch period of carvedilol extended~     release. In follow up to this observation, product labeling for both agents was updated and a~     nested case control study was subsequently conducted to examine the risk of serious~     hypersensitivity reactions i.e. anaphylactic reaction and/or angioedema among patients who~     used carvedilol extended release compared to carvedilol and separately compared to other long~     acting beta(β)-blockers. This proposed analysis is an update to the previously conducted~     analysis using the same database, LabRx, now containing 2 additional years of data, which~     should provide a larger number of carvedilol extended release exposed subjects.~   "
171773|NCT01316939|"~     A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of~     two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission~     over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the~     Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response~     (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK~     sponsored induction study. The primary endpoint will be proportion of subjects in remission~     at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical~     laboratory parameters including liver function tests, vital signs and electrocardiogram.~     Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes~     assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2,~     EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.~   "
171774|NCT01316926|"~     The study is prospective, open, randomized, crossover in steady state and the volunteers~     received multiple doses of the drug test and reference (two periods of drug administration).~   "
171775|NCT01316913|"~     This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study~     to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder,~     GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when~     administered once-daily over a 24-week treatment period in subjects with chronic obstructive~     pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will~     complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a~     24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone~     contact for adverse event assessment will be conducted approximately one week after the last~     study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the~     study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough~     (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment~     Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical~     laboratory tests.~   "
171776|NCT01316900|"~     This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study~     to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and~     GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when~     administered once-daily over a 24-week treatment period in subjects with chronic obstructive~     pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will~     complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a~     24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone~     contact for adverse event assessment will be conducted approximately one week after the last~     study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the~     study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough~     (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment~     Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical~     laboratory tests.~   "
171777|NCT01316887|"~     The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse~     events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue~     medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects~     with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated.~     A placebo arm is included to evaluate these products compared to an inactive control.~   "
171778|NCT01316874|"~     This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with~     carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus~     Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple~     courses of intravesical treatment.~   "
171779|NCT01316861|"~     The Purpose of This Study is to Evaluate the Efficacy and Safety of Acarbose in Type 2~     Diabetic Patients Using Two Different Formulations of Acarbose 50mg.~   "
171780|NCT01316848|"~     This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of~     1.5 mg tivozanib in normal healthy subjects.~   "
171783|NCT01316809|"~     Background:~      - AZD8055 is an experimental cancer treatment drug that works by inhibiting a protein called~     mTOR, which is known to promote tumor cell and blood vessel growth and to control tumor s~     energy and nutrient levels. AZD8055 is the first drug that inhibits both types of mTOR~     protein and is expected to be more effective than prior mTOR inhibitors. However, more~     research is needed to determine its safety and effectiveness in treating brain tumors known~     as gliomas that have not responded to standard treatments.~      Objectives:~      - To evaluate the safety and effectiveness of AZD8055 in individuals with gliomas that have~     not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with gliomas that have not~     responded to standard chemotherapy, surgery, or radiation.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          and tumor imaging studies.~        -  Participants will be separated into two treatment groups: one group that will receive~          surgery to remove the glioma and one that will not have surgical treatment.~        -  Participants in the nonsurgical treatment group will take AZD8055 by mouth daily for a~          42-day cycle of treatment. Participants will keep a diary to record doses and keep track~          of any side effects.~        -  Participants in the surgical treatment group will take AZD8055 by mouth daily for 7~          days, and then will have tumor removal surgery. At least 3 weeks after surgery,~          participants will resume doses of AZD8055 and will continue to take the drug for as long~          as the tumor does not recur.~        -  During treatment, participants will have regular visits to the clinical center,~          involving frequent blood and urine tests and other examinations to monitor the effects~          of treatment. Participants will have imaging studies to study the cancer's response to~          the treatment.~        -  Participants will continue to have cycles of treatment for as long as the treatment~          continues to be effective and the side effects are not severe enough to stop~          participation in the study.~   "
171784|NCT01316796|"~     Background:~      - Chronic leg ulcers are a complication of many blood disorders such as sickle cell disease,~     thalassemia, and other red blood cell disorders. In these disorders, red blood cells break~     down earlier than normal, which researchers suspect may cause or contribute to the~     development of leg ulcers; however, the exact cause is unknown, and current therapies are not~     very effective. Researchers are interested in determining if a research cream made with~     sodium nitrite, a substance that is known to increase blood flow by dilating blood vessels,~     may speed up the healing of skin ulcers.~      Objectives:~      - To evaluate the safety and effectiveness of topical sodium nitrite cream as a treatment for~     chronic leg ulcers in individuals with sickle cell disease or other red blood cell disorders.~      Eligibility:~      - Individuals at least 18 years of age who have sickle cell disease or another red cell~     disorder and have had a leg ulcer for more than 4 weeks.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          and an examination of the ulcer, including x-ray of the leg(s) with the ulcer and swabs~          from the wound.~        -  Participants will be scheduled for a 5-day inpatient stay at the Clinical Center, with~          the following procedures:~        -  Days 1 and 2: Participants will have blood draws, a wound assessment, ultrasound of the~          affected leg, imaging studies (magnetic resonance imaging and infrared photography),~          thermo-patch application to monitor temperature changes, measurements of blood flow in~          the skin, and questionnaires about pain and quality of life. An optional skin biopsy may~          also be conducted with samples taken near the skin ulcer~        -  Day 3: Participants will have one ulcer treated with the topical cream. Frequent blood~          draws will be conducted before application and then regularly for up to 6 hours after~          application of the cream. Thirty minutes after the research cream is applied,~          participants will have imaging studies of the treated leg and measurements of pain~          levels and blood flow.~        -  Day 4: Participants will have a blood draw and temperature recordings taken.~        -  Day 5: Participants will have the research cream applied and the same imaging studies as~          before, and will be discharged for care at home.~        -  For the following 3 weeks, participants will come to the clinical center twice a week to~          have the research cream applied to the leg ulcer and tests performed by the study~          researchers.~        -  For the fourth and final week, participants will return for additional cream treatment~          sessions, imaging studies, blood draws, and other tests as directed by the study~          researchers.~        -  Study participation will end in the following week (week 5). Subjects will come for a~          final visit one month after the end of the study.~   "
171785|NCT01316783|"~     Background:~      - African Americans have one of the highest rates of type 2 diabetes in the United States,~     and often have other medical problems related to obesity and cardiovascular disease. These~     conditions have various risk factors, including high blood sugar levels, high cholesterol~     levels, and insulin resistance. However, these risk factors have not been studied very~     closely in individuals with African ancestry, including Afro-Caribbean and sub-Saharan Africa~     migrant populations. Researchers are interested in conducting a genetic study on obesity,~     adult-onset diabetes, heart disease, and other common health conditions in individuals with~     African ancestry.~      Objectives:~      - To collect genetic and non-genetic information from individuals with African ancestry to~     study common health conditions related to obesity, adult-onset diabetes, and heart disease.~      Eligibility:~      - Individuals at least 18 years of age who self-identify as African American, Afro-Caribbean,~     or migrants from sub Saharan Africa.~      Design:~        -  Participants will undergo a physical examination and will provide a blood sample for~          study.~        -  Participants will also answer questions about personal and family medical history and~          current lifestyle behaviors.~        -  No treatment will be provided as part of this protocol....~   "
171786|NCT01316770|"~     Background:~      - Sj(SqrRoot)(Delta)gren s syndrome is an autoimmune disease (where the immune system attacks~     normal body tissues) that affects the salivary glands. Many people with~     Sj(SqrRoot)(Delta)gren s syndrome are not able to make enough saliva because their salivary~     glands are inflamed. The dry mouth that results can interfere with daily activities and can~     lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the~     parotid glands can improve saliva production in people with to Sj(SqrRoot)(Delta)gren s~     syndrome, but current treatment practices may provide only temporary relief. Researchers are~     interested in studying the effectiveness of stronger corticosteroid injections (using~     dexamethasone) to determine how the corticosteroid treatment actually works.~      Objectives:~      - To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva~     production in individuals with primary Sj(SqrRoot)(Delta)gren s syndrome.~      Eligibility:~      - Women between 18 and greater of age who have been diagnosed with primary~     Sj(SqrRoot)(Delta)gren s syndrome, and have had a biopsy of the minor salivary glands in the~     past 5 years that shows a moderate level of inflammation.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and salivary gland biopsies. Participants will also be screened~          with tests of saliva flow production and evaluation of the salivary ducts and glands,~          and will complete questionnaires about dry mouth symptoms.~        -  At the first treatment visit, participants will receive an injection of dexamethasone~          into one parotid gland and an injection of saline into the other gland. After the~          injections, participants will provide a blood sample to test the level of dexamethasone~          in the blood.~        -  Two weeks after the first treatment, participants will return for an evaluation visit to~          have saliva flow rate measurements taken, and will complete a questionnaire about dry~          mouth symptoms.~        -  Four weeks after the first treatment, participants will have a second treatment for each~          parotid gland, with the same tests and questionnaires as before.~        -  Participants will have additional evaluation visits 6 and 8 weeks after the first~          treatment visit, with a followup telephone call approximately 6 weeks after the last~          dexamethasone treatment visit.~   "
171787|NCT01316757|"~     This phase II trial is studying how well giving carboplatin, paclitaxel, cetuximab, and~     erlotinib hydrochloride together works in treating patients with metastatic or recurrent~     squamous cell head and neck cancer. Drugs used in chemotherapy, such as carboplatin and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving combination chemotherapy together with cetuximab and erlotinib~     hydrochloride may kill more tumor cells.~   "
171788|NCT01316744|"~     RATIONALE: Ketamine hydrochloride may lessen neuropathic pain in patients with cancer. It is~     not yet known whether ketamine hydrochloride given together with the best pain management is~     more effective than a placebo given together with the best pain management in treating~     neuropathic pain in patients with cancer.~      PURPOSE: This randomized phase III trial is studying ketamine hydrochloride given together~     with the best pain management to see how well it works compared with giving a placebo~     together with the best pain management in treating cancer patients with neuropathic pain.~   "
171801|NCT01316562|"~     The purpose of this study is to determine the predictive value of standardized cognitive~     tests performed in health examination centres for the diagnosis of Alzheimer's disease and~     related disorders among adults aged 65 years and older with a subjective memory complaint.~   "
171789|NCT01316731|"~     Rationale: Proteins released from muscle during and shortly after exercise, often referred to~     as myokines, may be central to our understanding of the cross-talk during and after exercise~     between skeletal muscles and other organs, in particular the liver. So far only a few~     myokines are identified (e.g. IL-6, IL-8, IL-15, TNF-alpha). Taking into account the role of~     these several known myokines in developing insulin resistance, revealing new putative~     myokines might provide valuable information and a direction for future research on the~     pathogenesis and treatment of type 2 diabetes mellitus.~      Objective: The objective of the present study is to identify novel myokines, expression of~     which is altered in skeletal muscle after a single bout of exercise.~      Study design: experimental study. Study population: Ten healthy, male subjects between 40 and~     60 years of age and BMI < 30 kg/m2, will participate in this study.~      Intervention: A single exercise bout that consists of one hour one-legged cycling on a~     adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as~     control for the exercising leg.~      Main study outcomes: Main study outcomes include upregulation of genes in skeletal muscle~     after exercise (with a focus on genes encoding myokines) and changes of blood plasma levels~     of selected proteins after exercise.~   "
171790|NCT01316718|"~     The purpose of the trial is to define the clinical benefit and possible mediators of the~     benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea.~      The investigators will therefore evaluate symptoms (primarily bowel frequency) and markers~     reflecting mast cell activation and small bowel tone.~   "
171791|NCT01316705|"~     This study aims to determine if early embryonic development, in D2 and D3 and the blastocyst,~     is compromised by the fine morphology of sperm nucleus. This will draw the IMSI, in which~     sperm will be chosen using the classification MSOME and ICSI in which sperm morphology is~     elected with less magnification. Both techniques are performed in oocytes of donor , being~     the coohorte used for both techniques picked at random. All courses will begin as a crop~     sequence, using the criteria of the IVF laboratory. Transfers will be made in blastocyst~     stage (D5 or D6), except in cases where the number of fertilized is less than 6 or fewer than~     6 embryos of acceptable quality in D3, which would transfer the same D3 . With donor oocytes,~     the quality of these need not be compromised and to perform the same technique in all oocytes~     results in pure transfers with both techniques. It allows us to compare results in term of~     pregnancy, implantation and early abortion rate, as well as embryo quality.~   "
171792|NCT01316692|"~     RATIONALE: Aurora A kinase inhibitor MLN8237 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well Aurora A kinase inhibitor MLN8237 works in~     treating patients with unresectable stage III-IV melanoma~      Funding Source - FDA OOPD~   "
171793|NCT01316679|"~     Specific urine proteases or groups of these enzymes can be reliable biomarkers and an~     effective gauge of response to therapy in patients with hepatocellular carcinoma.~   "
171794|NCT01316666|"~     The autonomic or automatic nervous system helps control blood pressure. Diseases of the~     autonomic nervous system may result in a drop in blood pressure on standing in many cases~     leading to fainting. Diseases that affect the autonomic nervous system include pure autonomic~     failure, multiple system atrophy and Parkinson's disease, and can present with very similar~     symptoms and it is sometimes difficult to determine an exact diagnosis. The purpose of the~     study is to find out if the blood pressure response from taking a single dose of the~     medication atomoxetine can help in the diagnosis of these diseases.~   "
171795|NCT01316653|"~     The purpose of this study is to conduct a randomized controlled trial that examines how a~     family based, community centered intervention effects early childhood BMI trajectories.~   "
171796|NCT01316627|"~     Body Dysmorphic Disorder (BDD) is a disabling condition that until recently has been largely~     ignored. Sufferers of BDD worry excessively and unreasonably about some flaw in their~     appearance that may be minimal or even nonexistent. These internalized body image distortions~     prompt sufferers to constantly check the perceived defects in mirrors, seek reassurance of~     their images from others, obtain unnecessary cosmetic and/or dermatological procedures, and~     even conduct self-surgeries. These obsessive concerns and compulsive behaviors cause~     significant emotional distress and often significantly interfere with global functioning.~     Currently, cognitive-behavioral therapy (CBT) in conjunction with psychopharmacology is the~     preferred treatment for BDD. In addition, two relatively new exposure techniques (mirror~     retraining method and crooked mirror externalization therapy) that utilize mirrors to~     exaggerate the patient's imagined defect appear to increase the benefits of CBT. However, the~     treatment efficacies of these relatively novel methods have not been rigorously tested or~     methodologically compared. Although six out of seven patients treated with crooked mirror~     externalization therapy at the Westwood Institute for Anxiety Disorders, Inc. demonstrated~     significant gains, the small sample size does not allow for any significant generalizations.~     Thus, the goals of this project are: 1) to determine the efficacy of exposure therapy that~     utilizes mirrors in the treatment of BDD, and 2) to evaluate the level of effectiveness of~     the mirror retraining method versus the crooked mirror externalization therapy. To accomplish~     these goals, each subject taking part in the study will do the following. They will go~     through an in-depth interview with the study physician, Dr. Kagan, and complete several~     clinical assessment questionnaires to confirm that they have BDD according to the Diagnostic~     and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV). They will be assessed~     by the study independent evaluator and complete several paper-and-pencil tests to determine~     the severity of the BDD and if they have any cognitive difficulties. The subject will~     participate in 3 weeks of CBT with either the mirror retraining method or the crooked mirror~     externalization therapy. After the CBT, we will repeat the clinical assessment questionnaires~     and neurocognitive testing. From the difference between the before and after scores on all~     these tests, we will determine if there has been any change in the subject's BDD symptoms,~     and if so, the level of effectiveness between the mirror retraining method and the crooked~     mirror externalization therapy.~   "
171797|NCT01316614|"~     The purpose of this study is to determine that there is no difference in final diagnosis of~     FNA specimens without a stylet, compared to using a stylet, when examined by a skilled~     cytopathologist.~   "
171798|NCT01316601|"~     Test safety and efficacy and of a novel IL-13 AB in the treatment of perianal fistulas~        -  Trial with medicinal product~   "
171799|NCT01316588|"~     The purpose of this study is to measure the time to recolonization intraoperatively after~     preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of~     differential bacterial growth with or without plastic adhesive drape on the chest as well as~     with or without microbial sealant on the leg.~   "
171800|NCT01316575|"~     The purpose of this study is to determine whether prophylactic nasal continuous positive~     airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative~     pulmonary function following elective bowel surgery. The investigators hypothesize that one~     hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2)~     when compared to the standard treatment of low flow oxygen applied by face mask.~   "
171828|NCT01316211|"~     A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal~     stenosis with concomitant low back pain by decompression with and without additional~     stabilization using the coflex® Interlaminar Technology~   "
171802|NCT01316549|"~     Fludarabine is a chemotherapy drug used extensively in bone marrow transplantation. The goal~     of this study is to determine what causes some children to have different drug concentrations~     of fludarabine in their bodies and if drug levels are related to whether or not a child~     experiences severe side-effects during their bone marrow transplant. The hypothesis is that~     clinical and genetic factors cause changes in fludarabine drug levels in pediatric bone~     marrow transplant patients and that high levels may cause severe side-effects.~   "
171803|NCT01316536|"~     The study is designed to analyze the use of music therapy to decrease pain and agitation in~     intubated ICU patients.~   "
171804|NCT01316523|"~     Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's Lymphoma.~     It is approved for the treatment of multiple myeloma and myelodysplastic syndrome.~      Rituximab is effective as a single agent and in combination with chemotherapy for indolent~     Non-Hodgkin's Lymphoma.~      The purpose of this study is to see how well giving lenalidomide together with rituximab~     works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma.~      Lenalidomide will taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until~     the disease progresses, unacceptable side effects or after twelve cycles if the patient is~     responding well.~      Rituximab 375 mg/m2/wk x 4 weeks will begin on Day 15 of cycle 1. After 4 cycles of therapy,~     if patients respond well to treatment, patients will receive a second course of Rituximab.~      Blood samples will be collected to assess how the immune system is functioning.~   "
171805|NCT01316510|"~     Infants born with gastroschisis usually require surgery shortly after birth. After surgery~     the intestine is often unable to digest human milk or formula for weeks or months. During~     this time the baby has to remain in the hospital to receive special nutrition through an IV.~     How bacteria colonize the intestine in these babies is unknown. Probiotics are bacteria that~     appear to have beneficial effects on digestion. This study will test whether giving probiotic~     bacteria to babies after surgery for gastroschisis will change the bacteria in the intestine~     to be more like those of a healthy breast-fed baby.~   "
171806|NCT01316497|"~     The purpose of this study was to investigate if repeated inflation of a blood pressure cuff~     applied around one leg causing mild ischemia (remote ischemic preconditioning) could~     protect children operated for congenital heart disease from developing acute kidney injury.~   "
171807|NCT01316484|"~     The primary objective of the study is to evaluate how patients with gastroparesis interpret~     the instructions, item content, and response options of a daily diary questionnaire designed~     to assess the key symptoms of gastroparesis.~   "
171808|NCT01316471|"~     The purpose of this study is to evaluate the efficacy of a web-based (i.e., internet)~     behavioral program to reduce pain and improve functioning in children and adolescents with~     chronic pain. We hypothesize that children and adolescents in families that receive the~     web-based behavioral program will report reduced pain levels and improved daily functioning~     compared to children and their parents who receive online patient education.~   "
171809|NCT01316458|"~     To investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with~     rising PSA following radical prostatectomy, to produce a sustained biochemical response~     during the first 6 months of treatment.~   "
171810|NCT01316445|"~     Approximately 3 million individuals suffer from epilepsy in America alone and about 200,000~     new cases of epilepsy in America are diagnosed each year (Epilepsy Foundation, 2005).~     Epilepsy can be defined as a condition in which a person has recurrent, unprovoked seizures.~     Prolonged or back-to-back repetitive seizures, known as acute repetitive seizures (ARS),~     are medical emergencies. ARS can occur unexpectedly, a circumstance for which quick and~     efficient antiepileptic drugs are needed for household and prehospital use. Currently,~     benzodiazepines are the antiepileptic drug of choice when dealing with ARS because they are~     proven to be efficient and take little time to work. Benzodiazepines can be administered by~     mouth, by vein via a needle (intravenously; IV), rectally, between the cheek and gum~     (buccally), or in the nose (intranasally; IN). The nasal formulation is not yet FDA-approved.~     The rectal treatment route has been commonly used for acute seizure treatment in past years,~     but recent studies propose that the nasal route for benzodiazepines may be better overall for~     home treatment and easier to administer (see Wermeling, 2009). For many out of hospital~     situations, nasal benzodiazepines can be more convenient and more comfortable than rectal~     treatment. In addition to the above benefits, nasal benzodiazepines are rapidly absorbed by~     the blood vessels in the nose and the time of drug administration and cessation of seizures~     may thus be reduced using nasal routes. This study sets out to characterize how fast buccal~     and nasal treatments begin to work on the brain by monitoring brain waves during~     administration of the drug, and to determine whether nasal or buccal administration is best.~   "
171811|NCT01316432|"~     The purposed of the study is to evaluate the pharmacokinetics (PK) response of continuous~     subcutaneous (SQ) infusion of cenderitide, as compared with a single SQ bolus.~   "
171812|NCT01316419|"~     This observational study is designed to evaluate the effects of Twynsta tablets with life~     style modifications on blood pressure, quality of life, and other risk factors in Korean~     patients with hypertension in a routine clinical practice setting.~   "
171813|NCT01316406|"~     The aim of this study is to evaluate the safety and efficacy of ATH008 cream in patients with~     Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy. In part~     I, the safety and plasmatic levels of the active ingredient and its metabolite will allow to~     determine the most appropriate and beneficial dose for the second part of the study. In Part~     II, the efficacy of ATH008 cream in reducing the number of patients presenting PPES grade 2/3~     secondary to capecitabine therapy following a four times daily application will be tested.~   "
171814|NCT01316393|"~     In the present study with a randomized, cross-over, blind, placebo controlled design, the~     effects of a salivary substitute product and a new mucoprotective product with similar~     mechanisms of action but with different composition and characteristics will be evaluated in~     cancer patients suffering from xerostomia.~   "
171815|NCT01316380|"~     The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium~     compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be~     delivered via Respimat inhaler and will be examined on top of maintenance inhaled~     corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be~     assessed by measuring the effects on lung functions, effects on lung exacerbations, effects~     on asthma control and numbers of adverse events.~   "
171816|NCT01316367|"~     BACKGROUND: Individual health education is considered to be essential in the overall care of~     patients with type 2 diabetes (DM2), although there is some uncertainty regarding its~     metabolic control benefits. There have been very few randomized studies on the effects of~     individual education on normal care in DM2 patients with a control group, and none of these~     have assessed the long-term results. Therefore, this study aims to use this design to assess~     the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational~     Diagnosis, and Evaluation) education model in the metabolic control and the reduction of~     cardiovascular risk factors, in patients with type 2 diabetes.~      METHODS: An open community randomized clinical trial will be carried out in 8 urban community~     health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2 will be~     randomized in two groups: PRECEDE or conventional model for health promotion education. The~     main outcome measures is glycated hemoglobin A1C, body mass index (BMI), blood pressure,~     lipids and control criteria during the 2-year follow-up period.~   "
171817|NCT01316354|"~     Sedentary lifestyles and increasing obesity are main causes of the global increase in the~     prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality,~     particularly composition of carbohydrate play also a significant role. The glycemic index~     (GI) describes in relative terms rise of blood glucose after ingestion of carbohydrate-rich~     food. Purified dietary fibre as β-glucan (BG) has been shown to reduce GI and affect levels~     of satiety hormones. In contrast, our knowledge of the physiological effects of arabinoxylans~     (AX), which constitute a substantial part of dietary fibre in cereal products, is limited.~     The investigators also lack a deeper understanding of the importance of whole grain (whole~     grain with whole kernels, and purified dietary fibre) in relation to Mets and T2DM.~      Hypothesis: The composition of dietary carbohydrates can be designed so that they improve the~     glycemic and insulinaemic responses and increase satiety feeling. This can be detected in~     metabolic parameters in subjects with Mets.~      The aim of our study is in subjects with Mets to compare the effect of acute consumption of~     bread rich in (a) purified AX, (b) purified BG, (c) rye bread with whole kernels (RK), with a~     (d) control group with consumption of white bread (WB).~      The primary endpoint is GI. Secondary endpoints are the following items: glycemic load,~     insulin index, glucose, insulin, glucagon, inflammatory markers, incretins, rate of gastric~     emptying, and metabolomics. Also satiety feeling will be measured.~      This project will improve opportunities for identifying and designing foods with low GI that~     is particularly suited to people who are at high risk of developing T2DM. The investigators~     also expect to gain a greater understanding of the metabolic fingerprint, as seen after~     ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods~     affect health by altering metabolic processes. This will give us a deeper insight into the~     metabolic processes that are necessary for maintaining normal glucose homeostasis.~   "
171818|NCT01316341|"~     the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple~     oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d. administered to~     Chinese female and male patients with type 2 diabetes will be investigated.~   "
171819|NCT01316328|"~     The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase~     II single-arm study. The use of a single dose tumor bed is expected to be very effective in~     terms of tumor control, but it could increase the incidence of radiation induced erythema.~     Therefore, the investigators assumed that a decreased DNA repair capability, as well as a~     reduced detoxification of the damage caused by oxidative stress could explain the increased~     acute toxicity, i.e. a higher incidence of erythema after a single dose. For this reason the~     investigators decided to investigate SNPs of genes involved in antioxidant and DNA damage~     repair pathways such as GST, XRCC1, XRCC3 and RAD51.~      The investigators assumed an erythema rate of 20% and 54% in patient groups at low and high~     risk, respectively, (groups were identified based on the absence/presence of the above~     polymorphisms alone or in combination), thus the minimum sample size was 56 patients with~     α=0.05, 2-tailed test and a power of the study of 80%.~   "
171820|NCT01316315|"~     The purpose of this study is to determine whether a single IV dose of N6022 will have a~     significant bronchoprotective effect, compared with placebo, during methacholine challenge.~   "
171821|NCT01316302|"~     This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the~     symptoms of Generalized Social Anxiety Disorder (SAD).~   "
171822|NCT01316289|"~     This prospective case series will essentially examine the influence of reduction quality on~     the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures~     treated with plate fixation.~      The plates used in this trial can be chosen according to the preferences of the surgeon.~   "
171823|NCT01316276|"~     The purpose of this study is to evaluate the long term safety and tolerability of Arikayce in~     Cystic Fibrosis patients. This long-term, open-label, multi-cycle extension study will enroll~     subjects who have successfully completed study TR02-108, were compliant with the study~     protocol, and did not meet any of the listed study discontinuation criteria. The safety and~     tolerability of Arikayce will be evaluated for up to approximately 2 years.~   "
171824|NCT01316263|"~     The purpose of this study is to evaluate the tumor response of stable disease (SD), partial~     response (PR), or complete response (CR) [according to Response Evaluation Criteria In Solid~     Tumors version 1.1 (RECIST v1.1 criteria)] at 12 weeks in participants with Gastrointestinal~     Stromal Tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRα)~     mutations and patients with GIST not harboring PDGFRα mutations.~   "
171825|NCT01316250|"~     The results of the International Randomized Study of Interferon and STI571 (IRIS) trial~     indicate that in patients with chronic phase CML treated with first line imatinib,~     achievement of a complete or partial cytogenetic response (CCyR or PCyR) at 12 months is~     associated with a significantly better progression-free survival (PFS).~      Second generation tyrosine kinase inhibitors such as nilotinib can overcome imatinib~     resistance because of greater potency to bind to BCR-ABL. Recent results indicate that, in~     patients with previously untreated chronic phase CML, nilotinib results in a faster and~     higher rate of CCyR or PCyR than imatinib. However, nilotinib use is associated with diet~     restriction and much higher financial cost.~      The primary objective of this study is to evaluate the ability of imatinib to maintain a~     complete cytogenetic response (CcyR) in patients who achieved a CCyR after 12 months of~     first-line treatment with nilotinib.~   "
171826|NCT01316237|"~     A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the~     Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve~     Subjects with Chronic Hepatitis C Virus Infection.~   "
171827|NCT01316224|"~     Psoriatic Arthritis (PsA) is a comorbidity that affects a significant proportion of~     participants with moderate or severe psoriasis. The purpose of this study was to describe the~     profile of patients with moderate or severe plaque psoriasis (Ps) in Colombia and to evaluate~     adalimumab efficacy and safety profile.~   "
171829|NCT01316198|"~     The objective of the study was to investigate the influence of a intervention with lutein und~     zeaxanthin from crucifers on the optical density of the macular pigment of patients with non~     exudative age-related maculopathy. It is hypothesized that the applied study beverage~     elevates plasma concentrations of the administered xanthophylls and the optical density after~     4 weeks of intervention.~   "
171830|NCT01316185|"~     The purpose of this study is to assess the optimal dose of EBP921 by comparing the efficacy~     and safety of 2 dose regimens in patients with chronic HDV.~   "
171831|NCT01316172|"~     This study intends to evaluate consultation in the Emergency Department. The purpose is to~     demonstrate that standardizing communication in the Emergency Department may lead to improved~     consultation.~   "
171832|NCT01316159|"~     Although atherosclerosis is a systemic disease, its manifestations are focal and eccentric,~     and each coronary obstruction progresses, regresses, or remains quiescent in an independent~     manner. The focal and independent nature of atherosclerosis cannot be due solely to the~     presence of systemic risk factors such as hyperlipidemia, diabetes mellitus, cigarette~     smoking, and hypertension. Local factors that create a unique local environment are a major~     determinant of the behavior of atherosclerosis in a susceptible individual.~      The vascular endothelium is in a unique and pivotal position to respond to the extremely~     dynamic forces acting on the vessel wall due to the complex 3-D geometry of the artery.~     Mechanical forces in general, and fluid shear stress (endothelial shear stress [ESS]) in~     particular, elicit a large number of humoral, metabolic and structural responses in~     endothelial cells.~      Regions of disturbed flow, with low and oscillatory ESS (< 1.0 Pa), are intensely~     pro-atherogenic, pro-inflammatory, and pro-thrombotic, and correlate well with the~     localization of atherosclerotic lesions. These sites demonstrate intense accumulation of~     lipids, inflammatory cells, and matrix degrading enzymes which promote the formation of~     high-risk thin-cap fibroatheroma.~      In contrast, physiologic laminar flow (1.0-2.5 Pa) is generally vasoprotective. However, as~     the obstruction progresses and further limits blood flow through a narrowed lumen, flow~     velocity and ESS may increase excessively (> 2.5 Pa) at the neck, and decrease abnormally at~     the outlet, increasing the likelihood of platelet activation and thrombus formation.~      Identification of an early atherosclerotic plaque likely to progress and acquire~     characteristics leading to likelihood of rupture and, consequently, to precipitate an acute~     coronary event or rapid luminal obstruction, would permit more definitive pharmacologic or~     perhaps mechanical intervention prior to the occurrence of a cardiac event. The potential~     clinical value of identifying and eradicating plaques destined to become vulnerable before~     they actually become vulnerable is enormous.~      The purpose of the PREDICTION Trial is to identify high-risk coronary lesions at an early~     time point in their evolution, to follow the natural history of these lesions over a 6-10~     month period, and to confirm that these high-risk lesions are likely to rupture and cause an~     acute coronary syndrome (ACS) or develop rapid progression of a flow-limiting obstruction.~     The hypothesis is that local segments in the coronary arteries with low ESS and excessive~     expansive remodeling will be the sites where atherosclerotic plaque develops, progresses, and~     becomes high-risk, leading to a new cardiac event. This study is being conducted in Japan as~     patients are clinically evaluated with followup coronary angiography and IVUS in a routine~     manner at 6-10 months following their initial percutaneous coronary intervention (PCI) for an~     ACS.~      This is a natural history and a clinical outcomes study in patients who initially present~     with an ACS. The natural history portion of the study is designed to describe the temporal~     progression of atherosclerosis in segments of coronary arteries with low ESS and expansive~     remodeling using intracoronary vascular profiling techniques utilizing intravascular~     ultrasound (IVUS) and coronary angiography. The clinical outcomes portion of the study is~     designed to evaluate the efficacy of coronary vascular profiling to predict segments of~     coronary arteries that will become areas of rapid plaque growth or rupture leading to~     recurrent major clinical coronary events.~      Five hundred (500) patients with acute coronary syndrome undergoing PCI for a culprit lesion~     are to be enrolled in the study to undergo coronary vascular profiling at the time of the~     index catheterization procedure. Up to 374 consecutive patients with at least one low ESS~     subsegment are to have follow-up coronary angiography and IVUS at 6-10 months to allow for at~     least 300 patients with analyzable intracoronary vascular profiling data for assessment of~     lesion natural history. All patients are to have a one-year clinical follow-up to assess for~     new cardiac events, followed by two additional years of extended clinical followup.~   "
171833|NCT01316146|"~     The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. Antibodies are proteins that protect the body from diseases caused by~     germs or toxic substances. They work by binding those germs or substances, which stops them~     from growing and causing bad effects. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including tumor cells or cells that~     are infected with germs. Both antibodies and T cells have been used to treat patients with~     cancers: they both have shown promise, but have not been strong enough to cure most patients.~     Investigators hope that both will work better together.~      Investigators have found from previous research that they can put a new gene into T cells~     that will make them recognize cancer cells and kill them. Investigators now want to see if~     they can attach a gene to T cells that will help them do a better job at recognizing and~     killing lymphoma cells.~      The new gene that investigators will put in T cells makes an antibody called anti-CD30. This~     antibody sticks to lymphoma cells because of a substance on the outside of the cells called~     CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been~     strong enough to cure most patients.~      For this study, the anti-CD30 antibody has been changed so that instead of floating free in~     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this~     way, it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells seem to~     kill some of the tumor, but they don't last very long and so their chances of fighting the~     cancer are unknown.~   "
171834|NCT01316133|"~     This study is to evaluate efficacy and safety of tacrolimus with steroid by observing~     remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid~     monotherapy.~   "
171835|NCT01316120|"~     Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our~     objective is to simplify the method of collection of female genital tract specimens by~     determining if vaginal dry swabs are as accurate as the standard transport medium for HPV~     diagnosis.~   "
171836|NCT01316107|"~     This study is to evaluate long-term safety and efficacy after concomitant administration of~     ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.~   "
171837|NCT01316094|"~     This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in~     type 2 diabetic patients with mild to moderate renal impairment.~   "
171838|NCT01316081|"~     In obese children, low antioxidant vitamin intake and reduced antioxidant capacity are~     common. Weight reduction reduces subclinical inflammation in obese subjects, and, similarly,~     antioxidant vitamins have been shown to reduce the expression of proinflammatory cytokines.~     Moreover, antioxidants reduce oxidative stress which influences endothelial function and~     might play a crucial role in the pathogenesis of obesity-related disorders. Furthermore,~     overweight children and adults have a markedly increased risk for iron deficiency. The~     mechanism linking obesity with iron deficiency is unclear. Growing evidence suggests that the~     elevated inflammatory status associated with obesity increases circulating hepcidin and this~     contributes to iron deficiency. Weight reduction has been shown to be associated with reduced~     inflammation and serum hepcidin concentrations, and an improved functional iron state. Thus,~     reducing inflammation in obese children may improve iron metabolism and reduce their risk of~     iron deficiency.~      Therefore, positive effects on subclinical inflammation, hepcidin/iron status and metabolic~     risk factors in obese children during weight loss may be enhanced by supplementation with~     antioxidants.~      The aim of the present study is to investigate the effect of 4-month antioxidant~     supplementation on subclinical inflammation, hepcidin, iron status and components of the~     metabolic syndrome in overweight children undergoing an outpatient weight-loss program.~      Our hypotheses are: 1. During an outpatient weight loss program, antioxidant supplementation~     will reduce oxidative and inflammatory stress associated with obesity to a greater extent~     than weight loss alone. 2. This will have two effects, compared to weight loss alone: a.It~     will reduce circulating hepcidin concentrations, and improve iron status. b.It will improve~     metabolic and cardiovascular risk factors.~      Subjects The investigators plan to enroll 50 children who are participants in outpatient~     weight-loss programs in the German part of Switzerland. Enrollment will be done with the~     agreement and assistance of the physician supervising the weight-loss program, and the timing~     of the study measurements will be incorporated within the existing program schedule. It is~     anticipated that the baseline blood sample for this study will be obtained from the regular~     baseline venipuncture for the weight-loss study. Criteria for participation include age~     between 10 to 18 years and a BMI over the 85th percentile for age and sex. Exclusion criteria~     include major medical illnesses, including gastrointestinal, inflammatory, bleeding and/or~     endocrine disorders, a history of nephrolithiasis, unusual dietary habits (e.g.~     vegetarianism), major food allergies or intolerances (lactose, gluten), smoking, and use of~     chronic medications or vitamin/mineral antioxidant supplements.~      Study design The study will be a double-blind, randomized, placebo-controlled intervention~     trial. Children will be randomly assigned to one of two groups: antioxidant (AO) or placebo~     (P) supplement. If it is necessary to enroll children from different weight-loss programs,~     then randomization will be stratified by program. During the 4-month weight loss period, the~     AO group will consume oral supplements of ascorbic acid (500mg), alpha tocopherol (400 IU),~     and 50 µg selenium (all from Burgerstein Vitamins, Rapperswil-Jona, Switzerland) each evening~     with diner, whereas the P group will consume identical-appearing placebo supplements.~   "
171839|NCT01316068|"~     Current therapies targeting albuminuria in diabetic nephropathy leave residual urinary~     albumin secretion, which meanwhile leave residual cardiovascular risk. Previous studies~     demonstrated that sulodexide could reduce albuminuria in type 2 diabetic patients. But no~     data concerning Chinese population is available. The investigators aim to provide evidence of~     effects of sulodexide on diabetic nephropathy in Chinese diabetic patients. Further the~     investigators also test the hypothesis that sequential administration of intravenous and oral~     replacement of the drug would gain an earlier and greater reduction of albuminuria, compared~     with oral use only.~   "
171840|NCT01316055|"~     The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram)~     tablets in healthy adult volunteers and those with mild and moderate renal impairment, and~     examine between group comparisons.~   "
171841|NCT01316042|"~     The primary objective of this study is to determine the safety and efficacy of metformin in~     lowering serum DHEAS levels in girls with premature pubarche and secondary, to observe~     changes in hormones associated with pubertal development including gonadotropins, sex~     steroids, insulin, adipocytokines, and growth factors.~   "
171842|NCT01316029|"~     The purpose of this study is to determine the symptomatic changes after a single session of~     laying-on-of-hands in various settings, and to evaluate optimal conditions for the outcomes.~   "
171843|NCT01316016|"~     The purpose of this study is to determine whether daily intake of a drink containing rose hip~     powder reduces risk markers of type diabetes and cardiovascular disease.~   "
171844|NCT01316003|"~     The aim of this study is to investigate the incidence and possible causes of obscured or~     disrupted cone outer segment tips line at fovea in spectral-domain optical coherence~     tomography images of normal eyes.~   "
171845|NCT01315990|"~     The purpose of this interventional study is to assess the progression free survival (one~     year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal~     prophylaxis.~      Further Objectives:~        1. Development of acneiforme follicular exanthema >= grade 2~        2. Duration until development of acneiforme follicular exanthema >= grade 2~        3. Development of paronychia~        4. Development skin fissure (hand and foot)~        5. Objective remission according RECIST 1.1~        6. Rate of secondary resections of liver metastasis with a curative approach~        7. Assessment of safety and tolerability~        8. Overall survival~        9. Progression free survival~   "
171857|NCT01315834|"~     The main purpose of this study is to examine the contribution of personality traits to~     marital satisfaction and well -being among couples coping with Coronary Heart Disease (CHD)~     and couples from the general population, and to health promoting behaviors and physical~     recovery among the ill partners.~   "
171920|NCT01315002|"~     The purpose of this study is to test the effects of nicotine on cognition with the following~     schizophrenia endophenotypes: prepulse inhibition, antisaccades, the continuous performance~     test, spatial working memory and a verbal memory task. Schizophrenia patients, unaffected~     first-degree relatives of schizophrenia patients and healthy controls receive transdermal~     nicotine in a double-blind, placebo-controlled, crossover study.~   "
171846|NCT01315977|"~     Aging is associated with increased risk of various diseases, and much attention is given to~     the use of natural products (like herbs) and 'functional food', such as teas, for healthy~     aging.~      The body is continuously exposed to potentially damaging agents (known as free radicals). The~     imbalance between the amount of free radicals and that of antioxidants in the body is known~     as oxidative stress. It is known that Type 2 DM is a state of increased oxidative stress,~     which is thought to lead to many long term complications of Type 2 DM, such as heart disease,~     vision problems and kidney failure. Antioxidant therapy, including increased consumption of~     antioxidant rich foods and beverages such as green tea, has been suggested as possibly~     beneficial in lowering the risk of these complications.~      The purpose of this study is to examine the effects of regular intake of green tea on indices~     of oxidative stress and antioxidant defense within cells, plasma and urine so as to~     investigate if regular intake of green tea can be recommended for health promotion.~   "
171847|NCT01315964|"~     Plant stanol esters as part of daily diet can decrease serum level of LDL-cholesterol up to~     10%. This decrease diminishes the risk of development of premature atherosclerosis and it´s~     complications (e.g., acute myocardial infarction) in adult human subjects.~      The purpose of the present study is to evaluate among healthy human subjects (N=100) effects~     of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on~     arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries,~     arterial blood flow and serum fats. The non-invasive arterial measurements (VaSera®, EndoPat®~     and WinCRPS®) are performed and blood samples are taken at the beginning and at the end of~     the 6-month-long study period. Also questionnaires concerning healthy, and life and dietary~     habits are fulfilled. Dietary records (twice for a 3-day-period) are done.~      Hypothesis of the study is that a dietary serum cholesterol lowering intervention has~     beneficial influence on the early prognostic markers of premature atherosclerosis.~   "
171848|NCT01315951|"~     The goal of this research is to demonstrate the use of petroleum jelly in prevention of~     nonscalp seborrheic dermatitis exacerbations at the first signs of a flare. In doing so, it~     will decrease the chronic use of topical steroids. The use of petrolatum should have~     favorable outcomes for patients, without the side-effects.~   "
171849|NCT01315938|"~     The purpose of this study is to investigate the clinical efficacy of abatacept on disease~     activity in polymyositis, and dermatomyositis patients.~   "
171850|NCT01315925|"~     SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze~     risk factors for developing an invasive fungal infection in patients with newly diagnosed~     Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those~     related to normal activities of daily life, such as occupation, location and type of~     residence, consume of tobacco, alcohol and others).~   "
171851|NCT01315912|"~     In a prospective interventional study, 44 Clomiphene resistant infertile patients were~     selected from Abolfazl Infertility Clinic of Bushehr University of Medical Sciences.~     Letrozole was given orally in a dose of 2.5mg, 5mg and 7.5mg, respectively. If the patient~     displayed no response, the dosage was increased. The size of follicle, endometrial thickness,~     estradiol, complications and clinical pregnancy rate were evaluated as the final outcome.~   "
171852|NCT01315899|"~     Raynaud's phenomenon (RP) is a disorder of the digital blood vessels resulting in episodic~     impairment of blood flow. During an attack of RP which commonly affects the hands and feet~     these arteries contract briefly which limits the blood flow (this is called a vasospasm) and~     deprived of blood the skin turns white then blue. The aim of this study is to prove the~     concept that ORM-12741 can prevent these blood vessel spasms.~   "
171853|NCT01315886|"~     The purpose of this study is to evaluate safety and efficacy when using a novel dose~     conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl~     (Abstral) for treatment of breakthrough cancer pain (BTcP).~   "
171854|NCT01315873|"~     Patients with myeloma that has either not responded to previous treatment or has returned~     after previous treatment will be given a combination of the drugs bendamustine and~     bortezomib.~      The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4~     of each cycle, with bortezomib being given first, before each dose of bendamustine. Each~     cycle will be 28 days long, so patients will be treated the first week of each cycle and then~     have 3 weeks 'off' (without any treatment). Disease assessments will be performed on day 22~     of each cycle. Patients will receive the study drugs until their disease progresses or they~     are withdrawn from the study.~      In other studies, bendamustine seems to work well with other drugs. Thus, this study hopes to~     show that the combination of bortezomib and bendamustine will have activity in~     relapsed/refractory myeloma.~   "
171855|NCT01315860|"~     Low back and posterior pelvic pain are common in pregnant females. Previous studies have~     demonstrated disability and it is estimated that all women experience some degree of~     musculoskeletal discomfort during pregnancy. Borg-Stein et. al. found 25% of pregnant females~     have temporarily disabling symptoms.~      There is demonstrated controversy over the mechanism of low back pain in pregnancy. The~     biomechanical theory implies that the enlarging uterus causes the maternal center of gravity~     to move anteriorly causing stress on the low back. Jensen et. al. demonstrated that weight~     gain correlated with biomechanical changes. The changes were measured by weight gain in~     segmental regions of the body and in principal moments of inertia from the sit to stand~     movement. Literature does not demonstrate a specific correlation between weight gain and the~     biomechanical changes of sway rate, lumbosacral angle and center of gravity. These three~     measurements may have a correlating effect on the underlying cause of low back pain in~     pregnant women.~      This study aims to determine the correlation between weight gain of pregnant females and the~     biomechanical changes of sway rate, lumbosacral angle and center of gravity. The change in~     weight over the last two trimesters will be correlated with the sway rate, lumbosacral angle~     and center of gravity. The degree of symptomatic low back pain as measured by the Oswestry~     Low Back Pain Scale will also be correlated with the sway rate, lumbosacral angle and center~     of gravity.~   "
171856|NCT01315847|"~     The purpose of this study is to determine the receptor occupancy (RO) associated with~     telcagepant (MK-0974) administration based on displacement of [11C]MK-4232 from the CGRP~     receptors in the brain using PET. The study enrolled healthy participants (Part I) and~     migraine patients (Part III). Due to a protocol amendment, study Part II was not conducted.~   "
171858|NCT01315821|"~     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal~     system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in~     newborn infants whose birth weights are < 1500 gr. Although bifidobacterium and lactobacilli~     sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii~     has not been used in the prevention of NEC in very low birth weight infants yet. The~     objective of this study is to evaluate the efficacy of orally administered S boulardii in~     reducing the incidence and severity of NEC in very low birth weight infants.~   "
171859|NCT01315808|"~     The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal~     population with risk factors of developing type 2 DM. There is no known diabetes model for~     predicting incident diabetes in an individual which takes into account the rate of change of~     HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time~     needed to implement the Diabetes Prevention Program measures.~   "
171860|NCT01315795|"~     An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide~     autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease,~     including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.~   "
171861|NCT01315782|"~     This is an observational study to understand the changes in alveolar dead space in medical~     critically ill patients with severe infection (severe sepsis) requiring mechanical~     ventilation and the possibility to predict multi-organ failure.~      The measurement of alveolar dead space used to require sophisticated equipment and time. New~     ventilators have microprocessors that allow rapid mathematical calculation with minimal~     intervention.~   "
171862|NCT01315769|"~     This study aimed to compare the pelvic floor muscle (PFM) strength in nulliparous and~     primiparous women. Subjective evaluation of PFM strength was performed vaginal digital~     palpation (TDP). The objective evaluation of PFM strength was assessed using a portable~     perineometer. All parameters were performed at one moment in G1, and in G2, during the 20th~     and 36th weeks of pregnancy, and 45 days after the delivery. Pregnancy and vaginal delivery~     may cause weakness of PFM.~   "
171863|NCT01315756|"~     It is hypothesized that the use of the mobile phone-based self-help system FTA, and with the~     patients as active players, will improve diabetes self-management reflected by improved~     glycemic control and lipids, self-care behaviours and lifestyle changes such as improved~     dietary habits and increased physical activity, compared with usual care. Following this; it~     is also hypothesized that this will also lead to a reduction in overall risk for diabetes~     complications (expressed by reduction in e.g., 5 year absolute risk for coronary artery~     disease as calculated using the Swedish National Diabetes Register's risk calculator) and in~     the prevalence of the metabolic syndrome (e.g., as defined by the International Diabetes~     Federation). It also hypothesized that health counselling based on TTM and CBT by a diabetes~     nurse, and with individualized feedback via sms from the diabetes nurse, may have an~     important function as a supplement to the self-help system (FTA). In addition, it is~     hypothesized that the patients' health status and diabetes-related quality of life (HRQL)~     will improve. The results of this study may show that a commonly used tool like the mobile~     phone, and also mobile phone together with health counselling, fitted into the patients'~     daily life, is more effective and cost-effective than standard care.~   "
171864|NCT01315743|"~     The goal of this exploratory pilot study was to develop and test the acceptability and~     feasibility of an innovative alternative high school-based intervention to prevent further~     weight gain and/or promote weight loss among a sample of ethnically and economically diverse~     adolescents.~   "
171865|NCT01315730|"~     The purpose of this research project is to test the effects of exposure of different forms of~     tactile speech feedback on overt stuttering frequency.~   "
171866|NCT01315717|"~     The purpose of this study is to examine and to compare gait characteristics under single- and~     dual-task conditions among healthy subjects together with AD patients at different stages of~     disease (i.e., pre-dementia, mild and moderate dementia stages).~   "
171867|NCT01315704|"~     The purpose of this study is to compare characteristics of gait and balance measured among~     patients with Alzheimer's disease or related disorders separated into 3 groups according to~     the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine~     the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to~     establish a database at Angers University Memory Centre.~   "
171868|NCT01315691|"~     A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence~     of chronic Pseudomonas aeruginosa infections. The Pseudomonas aeruginosa infection rate in CF~     patients increases with age and by age 18 years approximately 85% of CF patients in the US~     are infected. Liposomal amikacin for inhalation (Arikace™) was developed as a possible~     treatment for chronic infection due to Pseudomonas aeruginosa in CF patients.~      The purpose of this double-blind, placebo controlled study is to determine whether Arikace™~     is effective in treating chronic lung infections caused by Pseudomonas aeruginosa in Cystic~     Fibrosis subjects. The study will enroll approximately 300 subjects in clinics in the US,~     Canada, Europe, Australia and New Zealand. Subjects will be randomized to 590 mg Arikace™ or~     placebo and will receive treatment for 28 days followed by a 56 day safety follow-up period.~     The subjects will be required to visit the clinic 8 times (including the Screening visit)~     over a period of approximately 3 months. No overnight stays at the clinic will be required.~     At the completion of the TR02-109 protocol, subjects who have consented and meet study safety~     criteria may enroll in the long-term, open-label, multi-cycle extension study of 590 mg of~     Arikace™ (under a separate protocol TR02-110).~   "
171869|NCT01315678|"~     A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence~     of chronic Pseudomonas aeruginosa infections. The Pseudomonas aeruginosa infection rate in CF~     patients increases with age and by age 18 years approximately 85% of CF patients in the US~     are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible~     treatment for chronic infection due to Pseudomonas aeruginosa in CF patients.~      The purpose of this European Registration study is to determine whether Arikayce™ is~     effective in treating chronic lung infections caused by Pseudomonas aeruginosa in Cystic~     Fibrosis subjects. The effectiveness, safety and tolerability of Arikayce™ will be compared~     to TOBI, an inhalation antibiotic already available for use. The study will enroll~     approximately 300 subjects in clinics in Europe and Canada. Subjects will be required to~     visit the clinic 9 times (including the Screening visit) over a period of approximately 6~     months. No overnight stays at the clinic will be required.~   "
171871|NCT01315652|"~     The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse~     checking the preventive modalities and/or the presence of comorbidities such as infections (~     e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin,~     antiaggregant,anti-hypertensive treatment…), cancers (e.g.mammography,…), osteoporosis (e.g.~     bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the~     impact of an educational program aimed at permitting rheumatoid arthritis patients to~     auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).~   "
171872|NCT01315639|"~     The aim of this study is to examine the relationship between plasma putative biomarkers for~     Alzheimer's disease (i.e. Ab40 amyloid and total Ab42 amyloid, free, bound, free/bound,~     truncated, sAPPα) and :~        -  the risk of conversion of individuals with Mild Cognitive Impairment (MCI) into~          Alzheimer's disease (AD),~        -  the Alzheimer's disease progression rate.~   "
171873|NCT01315626|"~     A study of an educational intervention of primary care practice physicians to assist in the~     identification of patients who have Bronchiectasis and to assess the effectiveness of the~     specific didactic educational intervention targeting primary care physicians in the~     recognition of Bronchiectasis.~   "
171874|NCT01315613|"~     Acute pancreatitis is characterized by an inflammatory storm which regulatory pathways are~     not well known. The IL-1 cytokine family is activated early during acute pancreatitis and~     secretion of alarmins is speculated during pancreatic necrosis. IL-33 is a member of the IL-1~     family, it can act as an alarmin and its receptor, ST2, is known to sequester MyD88 which~     might regulate the acute pancreatitis inflammatory storm. The aim of this study is to~     investigate ST2 pathway in human acute pancreatitis and in murine experimental models of~     acute pancreatitis.~   "
171875|NCT01315587|"~     The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and~     durable effects to the apply traditional rTMS protocols. The aim of this study is to~     investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms~     and remission of cognitive functioning in patients with schizophrenia. In a randomized,~     double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital~     will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20 sessions.~     The negative symptoms and cognitive functioning will be assessed before the treatment (pre~     test) during the treatment (session 10), and after the treatment (post test).QEEG and LORETA~     apply before and after rTMS in all subjects.~   "
171876|NCT01315574|"~     The purpose of the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z)~     and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma~     medications may be associated with decreased tear production and tear film break-up time~     (TBUT), and increased inflammatory cells in the conjunctiva (membrane lining of the eye lids~     and the covering of the eye) leading to dry eye. Normal tear film (coating of the eye) is~     continuous and blinking maintains the tear film continuity. If you keep your eyes open long~     enough without blinking, the tear film will start breaking up. Your eye will feel~     uncomfortable forcing you to blink. In patients with dry eyes, the tear film is unstable, and~     breaks up faster. Therefore the tear break up time in patients who have dry eyes is shorter.~      In this study, the investigators will be comparing the two previously mentioned FDA-approved~     eye drops Latanoprost and Travoprost. The difference between the two medications is a~     preservative called benzalkonium chloride (BAK). Latanoprost contains BAK while Travoprost~     does not. The investigators will be comparing the efficacy of each medication in lowering IOP~     as well as trying to track the density of immune cells across the corneal surface by taking~     photos of your eye. The investigators will also be assessing whether either drop leads to~     symptoms of dry eye by comparing results from ocular surface exam tests such as TBUT.~   "
171877|NCT01315561|"~     Motion style acupuncture treatment(MSAT) is a treatment method in which the patient is~     exposed to active or passive movement and exercise during acupuncture, as opposed to~     conventional acupuncture. The purpose of this study is to investigate the effect of MSAT in~     the treating pain and severe functional disability in acute LBP patients.~   "
171878|NCT01315548|"~     The aim of the study is to assess the accuracy of real-time perfusion imaging pattern of~     pancreatic focal lesions visualized by contrast-enhanced harmonic endoscopic ultrasound~     (CEH-EUS) for the differential diagnosis between chronic pseudotumoral pancreatitis and~     pancreatic cancer in a prospective multicenter design.~      The study will include patients with focal pancreatic masses evaluated by CEH-EUS and~     EUS-FNA. The diagnosis is usually unknown in the moment of the initial evaluation, the~     patients being included based on a suspicion of focal pancreatic masses after transabdominal~     ultrasound, CT or MR examinations. However, after a complete evaluation, a final diagnosis~     will be reached based on the combination of EUS-FNA cytology/pathology, surgical pathology~     and minimum 12 months follow-up.~   "
171879|NCT01315535|"~     The literature does not discuss if the fast oral appliance titration (30 days period) in~     Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in~     such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important~     side effects observed in OSAS treatment with oral appliance. Since the effectiveness of~     mandibular exercises in the control of TMD pain has already been verified, it may play a~     fundamental role in the support of the fast oral appliance titration.~   "
171880|NCT01315522|"~     Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard~     intervention for the relief of obstructive jaundice in patients with unresectable malignant~     biliary obstruction. Although plastic stents (PSs) were developed earlier, self-expandable~     metal stents (SEMSs) are now used widely as the initial choice for ERBD in this setting, as~     SEMSs offer longer patency.However, SEMSs do become occluded in some patients. There are a~     limited number of reports on the management of occluded SEMS with various results. The aim of~     this study is to compare the efficacy of ComVi stents SEMSs with uncovered SEMS in subsequent~     ERBD after the occlusion of initial SEMSs.~   "
171881|NCT01315509|"~     The investigators aim to assess the dental status of psychiatric patients suffering from~     severe mental illness (schizophrenia, bipolar disorder, ptsd, resistant depression).~   "
171882|NCT01315496|"~     This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human~     Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.~   "
171883|NCT01315483|"~     In the United States, overweight (BMI > 25 but < 30 Kg/m2) and obesity (BMI > 30Kg/m2) are~     increasing at epidemic rates. A significant association exists between being overweight or~     obese and breast cancer recurrence and survival. However, evidence continues to accumulate~     indicating that achieving or maintaining a healthy weight for height (Body Mass Index, BMI,~     18.5-25Kg/m2) is associated with a reduced risk for breast cancer and with a decrease in~     breast cancer associated mortality. Despite this, there is a lack of randomized controlled~     trials exploring this association and how the process of fat loss or being successful in~     actually reaching a healthy weight for height differentially affects biomarkers for cancer~     recurrence.~      Many dietary approaches for weight loss are currently available to the public, and each~     purports to offer advantages. However, there is little scientific evidence to indicate how~     these dietary approaches, some of which vary markedly in the foods that they limit or~     exclude, affect biomarkers for breast cancer risk. In particular, it is not know whether the~     critical factor in relation to weight and breast cancer is simply weight loss (negative~     energy balance), irrespective of the manner in which it is achieved, or if certain dietary~     approaches affect breast cancer risk biomarkers more favorably than others. Published data~     from our laboratory suggest that dietary pattern does matter, and therefore the goal of this~     study is to investigate the effects of two popular weight loss dietary approaches that differ~     in the extent to which they limit carbohydrate or fat consumption (with effects on dietary~     glycemic load) compared to a usual care group on prognostic markers for cancer recurrence in~     postmenopausal breast cancer survivors. The investigators hypothesize that in addition to the~     anticipated effects of fat loss on circulating levels of bioavailable sex steroid hormones,~     that the effects of excess fat on breast cancer prognosis can be attributed to three~     interrelated metabolic processes that affect cancer progression: altered glucose metabolism,~     chronic inflammation and excessive cellular oxidation.~   "
171884|NCT01315470|"~     The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of~     recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium.~     Several studies showed that GCSF improves embryo development and implantation and increase~     pregnancy rate.~   "
171885|NCT01315457|"~     The aim of this study is to propose infection prophylaxis from Asian multinational~     retrospective analysis of infectious complications in patients who were treated with~     alemtuzumab~   "
171886|NCT01315444|"~     Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia, attacks 20% of the~     Western population. These millions of patients are treated continuously with PPI for~     different periods, many for many years. Recently, rebound acid hypersecretion was recognized~     as a major clinical event after cessation of PPI therapy. Sustained hypergastrinemia due to~     daily PPI therapy causes increased acid-secretory capacity that appears when the drug is~     stopped. The transient increase in blood and urinary pH following gastric secretion has been~     termed the alkaline tide phenomenon. Carbonic acid, formed in the presence of the enzyme~     carbonic anhydrase, neutralizes intracellular hydroxyl ions produced as a result of luminal~     acid secretion. The bicarbonate generated is removed from the cell via the baso-lateral~     chloride bicarbonate exchanger. The investigators have shown in several studies that this~     phenomenon parallels acid secretion. Thus, stimulation of acid secretion with test meal~     increased base excess maximally after 45 minutes and these changes parallel peak acid output~     measured in gastric aspirate. The investigators hypothesize that gradual step down cessation~     of PPI will prevent this clinical relevant event. By measuring alkaline tide after PPI~     cessation the investigators may prove this hypothesis.~   "
171887|NCT01315431|"~     This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in~     combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through~     14) in a 21-day cycle.~   "
171888|NCT01315418|"~     This multicentric, randomized, double-blind and controlled study aims to examine the effect~     of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001~     (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common~     infectious diseases (cumulated number of infections during the intervention period: primary~     criteria), and on the Quality of Life in adults submitted to multi-stressor situation.~     Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for~     7-weeks.~   "
171889|NCT01315405|"~     After few years of evolution, patients with Parkinson's disease may develop apathy, with~     different degrees of severity. Apathy is characterized by a loss of interest for the others~     and for activities. The lack of social interactions in these patients may be due to an~     impairment in decoding emotional facial expression. Indeed, facial expression recognition,~     which is necessary to understand other's emotional state, requires a subclinical facial~     mimicking of the expression observed. Yet, one of the clinical signs of PD is amimia.~      This study aims to determinate if there is a facial mimicry disorder in PD ( Parkinson's~     disease )patients with emotional facial expression (EFE) recognition impairment, compared to~     healthy control subjects. We also want to know if this facial mimicry disorder is primary~     (subtended by facial mobility impairment, that is to say amimia) or secondary (related to the~     mirror neuron systems that allows us to activate similar neural networks when observing and~     feeling a specific emotion)~   "
171890|NCT01315392|"~     Delayed wound closure is considered by many to be the standard of care for the treatment of~     an open fracture. This study was conducted to determine the feasibility of a large~     multi-center prospective randomized clinical trial and collect the pilot data needed to~     compete for the funding for such a trial. The study was designed to compare immediate and~     delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes~     were the infection rates and fracture related complications in patients treated with~     immediate or delayed wound closure strategies.~   "
171891|NCT01315379|"~     The purpose of this study is to determine whether Prolonged Exposure Therapy (PE)is effective~     in the treatment of post-traumatic stress symptoms in children and adolescents with mild~     traumatic brain injury (m-TBI) due to motor vehicle accident.~   "
171892|NCT01315366|"~     The optimal dose of vitamin D needed to optimize beneficial effects on musculoskeletal~     outcomes remains to be defined. Equally unclear is the impact of vitamin D on fuel metabolism~     and insulin sensitivity in human subjects. Thus, the overall objective of this proposal is to~     test the hypothesis that in ambulatory overweight elderly individuals, vitamin D~     administration at doses higher than currently recommended will:~        1. Have a salutary effect on parameters of glucose and fuel metabolism. It will thus~          decrease indices of insulin resistance, improve lipid profile, and decrease markers of~          cardiovascular disease including adipokines, inflammatory cytokines, and markers of cell~          adhesion.~        2. Have a superior effect on indices of mineral and musculoskeletal metabolism, including~          bone remodeling markers, lean mass, and bone mineral density.~      We will investigate whether this effect is modulated by entry status of vitaminD and PTH as~     detailed below~   "
172620|NCT01305655|"~     Early intervention in children and adolescents who experience delayed MTX-clearance and renal~     dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to~     non-toxic metabolites to avoid life threatening complications.~   "
171893|NCT01315353|"~     Women sometimes develop cancer in an area called the cervix, which is the opening to the~     uterus, or womb. Women who have HIV are more likely to get this kind of cancer than women who~     do not have HIV. Nearly all of these cancers are caused by another virus, called human~     papilloma virus (or HPV). Other times, the cause of this cancer is not known.~      The investigators are looking for a better way to prevent cervical cancer. This study is~     comparing two different methods to prevent cancer of the cervix in women who have HIV. This~     study will also see if these methods are safe and tolerable in women who have HIV.~   "
171894|NCT01315340|"~     Ocular rigidity characterizes the relationship between pressure and volume changes in the~     human eye and is expressed as a macroscopic coefficient. Outflow facility is a measure of the~     resistance of the conventional outflow pathway and represents a parameter that is of interest~     in glaucoma.~      Difficulties in the measurement of ocular rigidity in the living human eye have limited our~     knowledge on this parameter. However, ocular biomechanics have been implicated in the~     pathogenesis of this disease. The aim of this study is to characterize the pressure volume~     relation and quantify ocular rigidity and outflow facility in glaucomatous and normal eyes.~     For this purpose, the investigators have recently developed a manometric method for the~     measurement of ocular rigidity and outflow facility.~   "
171895|NCT01315327|"~     This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the~     treatment of Tourette's Disorder.~   "
171896|NCT01315314|"~     The purpose of this study is to evaluate the effects of neutral pH and low glucose~     degradation product (GDP)-containing peritoneal dialysis fluid (PDF) on systemic inflammation~     and endothelial dysfunction markers in incident PD patients.~   "
171897|NCT01315301|"~     Aim of the study is to determine optimal time to initiate anti-retroviral therapy in HIV/TB~     co-infected patients who recently started treatment for Tuberculosis by comparing immediate~     versus deferred initiation of HAART.~      The study will address the following questions;~        -  Is it possible to reduce mortality rate and increase survival by early initiation of~          HAART during TB treatment with out compromising for adverse drug reaction, toxicity and~          immune reconstitution syndrome?~        -  What is the risk/ benefit ratio between immediate versus deferred initiation of HAART~          during TB treatment with respect to safety/efficacy of TB and HIV co-treatment?~        -  When is the most appropriate time to start HAART during TB treatment?~   "
171898|NCT01315288|"~     The purpose of this study is to determine patient variables, physician presenter variables,~     and information variables that might affect clinical decision making in asymptomatic carotid~     stenosis. The hypothesis is that information variables are the most significant determinant~     of clinical decision making.~   "
171899|NCT01315275|"~     The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on~     Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.~   "
171900|NCT01315262|"~     Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine~     monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the treatment~     of erectile dysfunction (ED). Objectives:~        -  To test the efficacy of Viagra 100mg on demand vs. Viagra 100mg daily (taken either at~          bedtime or 1 hour prior to sexual intercourse) in restoring erectile function following~          radical prostatectomy.~        -  To test the safety and tolerability of Viagra 100 mg on demand vs. Viagra 100 mg daily~          after radical prostatectomy.~   "
171901|NCT01315249|"~     The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol~     and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a~     26-week period in patients with moderate to severe COPD.~   "
171902|NCT01315236|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of~     daily dosing of 590 mg of LAI versus placebo in patients with recalcitrant NTM lung disease.~   "
171903|NCT01315223|"~     Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure~     (AHF) several times a year. Currently, we have no method for prediction of future~     developments of AHF. In our center we have investigated the monitoring of lung impedence as a~     predictor for future deterioration. It was found that a decrease in lung impedence of more~     than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we~     try to prove the hypothesis that preventive treatment according to lung impedence value may~     prevent future hospitalizations for AHF and improve clinical outcome.~      Patients recruited by year:~      2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5~   "
171904|NCT01315210|"~     To evaluate the safety and to determine the efficacy of D-ribose for the amelioration of~     fatigue in subjects with fibromyalgia. This is a phase IIa, randomized, double-blind,~     placebo-controlled, multi-center, multiple dose study of D-ribose versus placebo administered~     at doses of 5 g three times a day (TID) over a 12-week period to subjects who are~     experiencing fatigue associated with a diagnosis of fibromyalgia.~   "
171905|NCT01315197|"~     Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage~     for lower back pain occupational as well as to assess the influence of technique in~     performing work activities and life in the team nursing.~   "
171906|NCT01315184|"~     The purpose of this study is to evaluate the whether an automated telephone-based system is~     useful and helpful for opioid dependent patients receiving buprenorphine in primary care. The~     Recovery Line support system is a Therapeutic Interactive Voice Response system based on~     cognitive behavioral therapy (CBT). The Recovery Line support system includes a variety of~     modules presenting the basic principles and strategies of CBT. Each module includes learning~     sections and activities sections to provide direct guidance in using skills. The Recovery~     Line support system is interactive and also includes a questionnaire to help patients~     identify problems and recommend modules for use, as well as an inspiration section, an~     introduction, and an immediate assistance menu. Following development of an initial system~     the current trial will recruit 40 patients receiving buprenorphine maintenance from a~     physician provider in the local community. Patients will be randomly (flip of a coin) to~     receive the Recover Line Support system or to treatment as usual with their physician.~     Patients assigned to TIVR will be trained on the system and provided 24-hr access to the TIVR~     system for a four week period. Primary outcome variables will be how long patients remain in~     treatment, self-reported abstinence from opioids and other drugs, and abstinence as measured~     by weekly drug screens. It is expected that patients assigned to TIVR will better treatment~     outcomes than patients assigned to TAU.~   "
171907|NCT01315171|"~     Insulin treatment often causes the blood glucose levels to fall too low (hypoglycemia).~     Hypoglycemia can be associated with confusion and disorientation as well as other symptoms~     such as palpitations, sweating and tremors. Medium chain triglycerides (MCT) can be used as a~     fuel in the brain during low blood sugar levels and therefore may prevent or reduce some of~     the confusion and disorientation seen during hypoglycemia. We would like to determine if a~     diet supplemented with medium chain triglycerides can improve cognitive function during~     hypoglycemia, diabetes control and also look at brain activity.~   "
171908|NCT01315158|"~     This will be a randomized controlled trial that compares the rates of sedation related~     complications in high risk patients (ASA greater or equal to 3, BMI greater or equal to 30,~     those at risk for OSA) undergoing advanced endoscopy procedures with propofol alone compared~     to propofol in combination with benzodiazepines and opioids.~   "
171909|NCT01315145|"~     This is a multi-center, prospective, observational clinical study to compare patient outcomes~     following treatment with either the mild® procedure or epidural steroid injection in patients~     with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.~   "
171910|NCT01315132|"~     This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in~     matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to~     increase overall survival.~   "
171911|NCT01315119|"~     The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in~     reducing post-operative complications associated with low breast skin blood flow after breast~     reconstruction using implants.~   "
171912|NCT01315106|"~     The purpose of this study is to determine how well a new MRI technique called High~     resolution 3D diffusion-weighted breast MRI detects breast cancer.~   "
171913|NCT01315093|"~     The addition of heparin increases pregnancy outcome parameters in poor responders undergoing~     In Vitro Fertilisation (IVF)~   "
171914|NCT01315080|"~     The investigators recently proposed a new hypothesis on the pathogenesis of mammillary~     fistulae (MF) suggesting that occlusion of hair follicles by keratinous plugging may~     relevantly contribute to the development of MF. The investigators believe that the~     pathogenesis of MF mimics the behaviour of hidradenitis suppurative, as both clinical~     entities manifest themselves as a chronic, suppurative and recurrent inflammatory process.~     This new proposal has led to the present suggestion of a therapeutic alternative for MF.~   "
171915|NCT01315067|"~     Reliable and timely detection of acute rejections in renal transplant patients is important~     to preserve the graft function and to prevent premature graft failure. The current gold~     standard for the rejection diagnosis is a renal biopsy which is usually performed upon an~     unexplained decline in the graft function (determined by serum creatinine or clearance).~     Because of the insensitivity of creatinine determinations and the invasiveness of renal~     biopsies, non-invasive tests have been suggested to diagnose acute rejection including mass~     spectrometry (MS) analysis of urine samples.~      The ability of MS analysis to detect acute rejection has been demonstrated in small studies~     on selected patients but evidence is lacking that this test is efficacious in the routine~     setting of the post-transplant patient care. Based on our previous work that established~     urine peptide sets for acute rejection by MS, a prospective, multicentre diagnostic phase III~     study will be executed.~      The aim of the study is to prove that this test is as equally effective as the allograft~     biopsy to detect acute rejection in patients that undergo a biopsy for unexplained renal~     dysfunction. The perspective of this approach is that the test could be used either in place~     of the biopsy or as decision guidance whether a biopsy is necessary to confirm the presence~     of rejection. Another perspective is that the MS test (respectively, a simplified test system~     derived from this method) could be used in the regular post-transplant surveillance for acute~     rejection, in place of the relatively insensitive procedure with periodic monitoring of the~     graft function by creatinine determinations.~   "
171916|NCT01315054|"~     Methadone treatment has became one of main actions taken in China to control the spread of~     HIV among drug users. However，the average methadone dose used is relatively low. An intensive~     methadone maintenance treatment (MMT) provider training on methadone dosage may be effective~     in increasing the methadone dose levels prescribed to new patients. The study will evaluate~     the effectiveness of a tailored education program for MMT service providers using subsequent~     methadone dose prescribed to new patients. The effects of methadone dose, with and without~     the inclusion of additional psychosocial services, will then be measured through MMT~     retention and illicit opioid use.~   "
171917|NCT01315041|"~     Hot flushes are common symptoms in women after menopause, and are important causes of~     discomfort and lead to high number of medical consultations. Hormone replacement therapy is~     an effective treatment, however it can bring undesirable consequences and may be~     contraindicated for some women. Options are inhibitors of serotonin or~     serotonin-norepinephrine reuptake, gabapentin, herbal medicines and homeopathy. None of these~     therapies is widely accepted of effective. Therefore, the search for new therapeutic options~     is highly desirable. Ingestion of malagueta pepper fruits (Capsicum frutescens L. var.~     malagueta) causes sensations similar to those experienced by menopausal women during hot~     flushes. By the principle of homeopathy, the like cures the like, the objectives of this~     study are: (a) to determinate whether pathogenesis of a homeopathic medicine made from C.~     frutescens fruits include symptoms like hot flushes, and (b) whether this medicine is~     effective on hot flushes relief in women after menopause. There will be 2 distinct phases.~     Phase 1 is the determination of the medicine's pathogenesis in healthy volunteers, in a~     randomized placebo-controlled, double-blind design. Phase 2 is the investigation of the~     medicine's effects on hot flushes of women after menopause, in a randomized~     placebo-controlled, double-blind design. The investigators expect a significant reduction on~     symptoms perception, assessed by internationally validated tools. The study is expected to~     last for 18 months, with 36 patients included in each phase.~   "
171918|NCT01315028|"~     There is a need to develop a better understanding of the early phase of bipolar disorder, and~     to develop and evaluate effective psychosocial interventions that assist people in this~     phase. The purpose of this study is to determine whether or not it is feasible to conduct a~     larger study of the effectiveness of cognitive interpersonal therapy (a psychological~     therapy) with individuals who have experienced their first or second treated episode of mania~     or hypomania (symptoms common in early development of bipolar disorders).~   "
171921|NCT01314989|"~     Cyproheptadine is currently clinically used as an appetite stimulant for children with~     failure to thrive without underlying organic disease. Otherwise, no randomised control trial~     demonstrates the efficacy of Cyproheptadine on those patients. This is precisely what the~     investigators intend to demonstrate on this randomised placebo control cross-over trial. Our~     hypothesis is that Cyproheptadine is more efficient than placebo to improve weight gain and~     feeding behaviour on 2 to 4 years old children with failure to thrive.~   "
171922|NCT01314976|"~     Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is~     considered a possible cause of infectious gastrointestinal disease in adults and children. DF~     has a particular high prevalence in children, and it is suspected that children present more~     symptoms in infection than adults. However, evidence of causality is lacking, treatment~     regimens are largely untested in controlled trials, and the most commonly used antibiotic~     against DF in Denmark, metronidazole, has never been tested against placebo.~      Main objective: To determine the clinical effect of metronidazole in DF-infected children~     with gastrointestinal complaints, where no other aetiology is known and no other~     gastrointestinal pathogens could be shown.~   "
171923|NCT01314963|"~     This study evaluates the ability of a prototype intraoperative handheld gamma camera (pIHGC)~     to image (detect) sentinel lymph nodes (SLNs) in melanoma and breast cancer during surgical~     excision, as compared to standard of care intraoperative gamma probes (GP). The unit of study~     in this trial was SNLs rather individual participants. Each device was assessed for relative~     node detection sensitivity (S) of those SLNs.~   "
171924|NCT01314950|"~     The purpose of this study is to conduct a two-year randomized, controlled clinical trial to~     improve functioning among older adults with Alzheimer's disease by comparing a control group~     receiving best practices primary care with an intervention group receiving best practice~     primary care plus a home-based occupational therapy intervention.~   "
171925|NCT01314937|"~     Worldwide, over 2 billion people suffer from worm infections in developing countries. These~     infections are especially damaging to the health of children, resulting in both short-term~     and lifelong disability. Older children with worm infections are more likely to be stunted,~     underweight, vulnerable to other illnesses and perform poorly in school compared to~     non-infected children. Large-scale deworming programs in school-age children are therefore~     recommended by the World Health Organization (WHO). WHO also recommends deworming of~     preschool-age children (as of 12 months of age) in these areas; however, the benefits of~     deworming, especially in the 12-24 month age group, have been inadequately studied. This~     knowledge is urgently needed as studies show that all children have a similar potential for~     healthy growth and development, provided that appropriate nutrition and health interventions~     are given in the critical window of opportunity before the age of two.~      Therefore, the investigators are proposing to undertake a randomized controlled trial to~     determine the effect of deworming program for improving growth and development in children~     between 12 and 24 months of age. Our results will provide solid rigorous evidence on if,~     when, and how often, deworming should be integrated into routine child health care packages~     provided by Ministries of Health in the 130 countries in the world where worm infections are~     endemic.~   "
171926|NCT01314924|"~     We aimed to identify clinical and vascular parameters of treated hypertensive patients who~     present beneficial effects of dark chocolate for one-week period on vascular function.~   "
171927|NCT01314911|"~     People who are infected with the influenza virus may develop respiratory illnesses, such as~     pneumonia, or other life-threatening complications. Currently, there are four antiviral~     medications that are used to treat influenza. This study will examine one of these~     medications, oseltamivir, to examine how it affects the shedding of influenza virus in~     infected people.~   "
171928|NCT01314898|"~     24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid~     activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845~     can be established following single oral doses.~   "
171929|NCT01314885|"~     A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it~     has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute~     inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an~     internal control for the study.~   "
171930|NCT01314872|"~     This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations~     more effectively than placebo in participants with overactive bladder (OAB). The primary~     hypothesis of the base study is that administration of vibegron demonstrates a dose-related~     reduction, compared with placebo, in average number of daily micturitions in participants~     with OAB after 8 weeks of treatment.~   "
171931|NCT01314859|"~     This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The~     principal aim of this study is to compare the efficacy and safety of Nifedipine treatment~     versus Atosiban treatment over these patients' newborn babies.~   "
171932|NCT01314846|"~     Fertilization and embryo development in vivo occurs in appropriate conditions in the~     mammalian reproductive tract. However in assisted reproductive technology (ART) embryos and~     oocytes are exposed to certain factors such as temperature, O2 pressure and pH fluctuations~     that may affect embryo development and viability in vitro. In Preimplantation Genetic~     Screening program (PGS) the investigators need to culture the embryos until day 5 so the~     requirement of culture techniques must be optimal to produce acceptable blastocyst rates. As~     it has been shown before, embryo culture conditions have the potential to impact biopsied~     embryos and hence PGS success rates.~      Nowadays the coculture system with endometrial cells could be an alternative option to~     improve the blastocyst rates since some publications have indicated that endometrial cells~     may provide trace elements and growth factors that are not present in defined culture media~     and reproduce physiologic conditions. Although the role of coculture in vitro fertilization~     (IVF) has been controversial, a recent meta-analysis has established the potential benefits~     of coculture system.~      The aim of this study was to compare embryologic and clinical outcomes in terms of~     blastocyst, implantation and pregnancy rates to evaluate endometrial epithelial cell (EEC)~     coculture versus sequential culture system in advanced maternal age ( ≥39 years) in the PGS~     program.~   "
172621|NCT01305642|"~     To analyze the weight gain of very low birth weight infants during a minimum period of three~     weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been~     individually fortified.~   "
171933|NCT01314833|"~     In recent years, the increasing number of breast cancer patients shows the fact breast cancer~     is one of the most common cancers in women in China. However, the mortality rate has seen a~     dramatic decline mainly due to early detection of breast cancer and the use of effective~     multimodel treatment. Recent studies suggest breast cancers are heterogeneous and recognized~     by biological subtypes, which lead to markedly different clinical outcome.~      Adjuvant chemotherapy is widely used in the treatment for primary breast cancer patients.~     Different types of breast cancer cells are sensitive to different types of drugs.There is no~     data to support the information about the adjuvant chemotherapy regimens for different~     subtypes breast cancer patients， especially for Chinese women.~      The investigators hypothesized to confirm the possibility of finding the adjuvant~     chemotherapy aimed to different subtypes of breast cancer.~   "
171934|NCT01314820|"~     The present study investigated whether the presence of fluid in the joint affected peak~     torque and the root mean square (RMS) values of surface electromyography (EMG) in patients~     symptomatic for osteoarthritis (OA).~   "
171935|NCT01314807|"~     The aim of this prospective case-control study is to investigate the prevalence, severity and~     incidence of systemic consequences in newly detected patients with mild and moderate Chronic~     obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle~     dysfunction and physical inactivity as these factors are, together with smoking, potentially~     modifiable.~   "
171936|NCT01314781|"~     The aim of the present study is to investigate in patients with overactive bladder syndrome~     (OABS) whether a combination treatment of solifenacin with pelvic floor muscle training and~     whole body vibration training achieves a better treatment outcome than a treatment with~     solifenacin alone.~   "
171937|NCT01314768|"~     The investigators will perform a cluster randomised controlled study of Brief intervention~     (BI) for medication-overuse headache (MOH) versus business as usual. GPs will be trained to~     perform a structured brief intervention after identifying patients with probable MOH using~     the severity of dependence scale. The control arm will include patients of GPs who have not~     been trained in BI. Patients will be recruited by prior short postal screening of patients~     listed on the GPs patient lists.~      The hypothesis is that BI will lead to improvement of medication-overuse and chronic headache~     as compared to no BI.~      Main outcomes are:~        -  number of medication days per month~        -  number of headache days per month~        -  headache index~   "
171938|NCT01314755|"~     Study Hypothesis: The peri-operative enteral administration of a proprietary immune-enhancing~     feed (IMPACT) will not reduce post-operative infective complications in patients undergoing~     major surgery for squamous cell carcinoma of the Head and neck (SCCHN).~      Patients who present with SCCHN for whom surgery is the recommended treatment will, assuming~     they fulfill the eligibility criteria, be block randomised into a two-group, double-blind~     randomised controlled trial. One group will receive IMPACT, the other an iso-caloric,~     iso-nitrogenous control feed for 5 days pre and 7 days post-operatively. In both groups~     patients will be fed enterally. The feeds will be prepared in identical bottles to facilitate~     blinding. Primary outcome measures include major systemic infection, whilst secondary outcome~     measures include local infection and length of hospital stay. Follow-up will be for 30 days~     postsurgery.~   "
171939|NCT01314742|"~     The goal of this pilot study is to test the hypothesis that mechanically ventilated infants~     receiving Biotene OralBalance® gel for oral care would have a reduced intubation time~     compared to infants receiving oral care placebo. This study is also performed to test the~     feasibility as well the safety of Biotene OralBalance® gel.~   "
171940|NCT01314729|"~     Different types of retainers have been used to assure the stability of orthodontic treatment.~     The aim of this study is clinical and radiographic comparison and evaluation of two common~     types of lingual fixed retainers on the health of periodontium.~      The participants in this study will be examined both clinically and radiographically just~     after the completion of orthodontic treatment and after a 6-month-period.~      The results of the study will be analyzed with Mann-whitney and independent t-test.~   "
171941|NCT01314716|"~     The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and~     gram-negative airway infection. Participants received two 28-day courses of either Aztreonam~     for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a~     28-day off-drug period. Following the two blinded courses, all participants received a 28-day~     course of open-label AZLI then were followed for an additional 56 days.~   "
171942|NCT01314703|"~     The primary objective of this study is to measure the antimicrobial effectiveness of~     ChloraPrep one-Step.~   "
171943|NCT01314690|"~     The objectives of this study are: 1-To qualify the relationship between the gut microbiota~     and the host nutritional and metabolic status during dietary transition.2-To define the~     impact of nutritional transition on the intestinal microbiota and identify metagenomics~     signatures of nutritional transition.~   "
171944|NCT01314677|"~     This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography~     (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients~     with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG~     PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help~     doctors predict a patient's response to treatment and help plan the best treatment~   "
171945|NCT01314664|"~     The purpose of this study is to observe and describe the effectiveness and local tolerability~     of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a~     cohort of subjects treated under routine practice conditions.~   "
171946|NCT01314651|"~     The purpose of this study is to test the efficacy of a brief behavioral insomnia intervention~     in reducing headache frequency and severity among patients with chronic migraine and~     insomnia. It is hypothesized that this intervention will produce greater changes in headache~     frequency and severity than will a comparison treatment involving non-sleep-specific general~     lifestyle modifications.~   "
171947|NCT01314638|"~     The purpose of this study is to measure the adherence to Siel bleu balance exercises in~     patients with Alzheimer's disease, while taking into account the disease stages.~   "
171948|NCT01314625|"~     The purpose of this study is to determine whether the orthostatic hypotension reported among~     subjects during bortezomib-containing regimen is caused by a dysfunction of the autonomic~     nervous system (ANS).~   "
171949|NCT01314612|"~     Many combat Veterans suffer from posttraumatic stress disorder (PTSD), an anxiety disorder~     that develops after an extremely stressful event or events. PTSD is associated with problems~     falling asleep or staying asleep. Veterans with PTSD also commonly have nightmares from~     stressful experiences. These symptoms can cause problems in daily life. Behavioral treatments~     that do not involve taking medication have been shown to help improve problems related to~     sleep and nightmares. However, very few of these treatments address both sleep problems and~     nightmares at the same time, even though many people suffer from both problems. The purpose~     of this study is to examine the effectiveness of a combined treatment for sleep problems and~     nightmares in Veterans suffering from combat-related PTSD that is presented in a group~     format. The investigators hypothesize that the completion of this treatment will lead to~     increases in sleep quality and decreases in the frequency and severity of nightmares as~     measured by standard questionnaires.~   "
171950|NCT01314599|"~     Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum~     tolerated dose (MTD) and the recommended dose (RD) of PM01183.~   "
171951|NCT01314586|"~     Purpose: To demonstrate the efficacy of Beneflax™ flaxseed lignan (SDG) concentrate to lower~     serum cholesterol levels.~      Background: Flaxseed has been studied for various health benefits in humans, including~     prostate health, glucose control, and cardiovascular health. Cholesterol levels and high~     blood pressure are known to be risk factors for cardiovascular disease. Whole flaxseed has~     had variable effects on serum lipid levels, perhaps a consequence of variations in the~     amounts of secoisolariciresinol diglucoside (SDG) found in different flax cultivars, making~     the study of this bioactive compound difficult.~      Hypothesis: Flaxseed lignan (SDG) extract (Beneflax) significantly lowers total and LDL~     cholesterol. Flaxseed lignans also lower blood pressure and fasting glucose levels.~   "
171952|NCT01314573|"~     The purpose of the study is to examine the effects of different exercise intensity training~     programs upon blood vessel function and circulating blood cells involved in blood vessel~     repair in young women. The long term effects of exercise may be beneficial to cardiovascular~     health and it is important to understand the training methods that are the most beneficial.~     In particular we aim to determine if brief maximal exercise improves the function and~     stiffness of blood vessels and enhance blood vessel repair. Two methods of exercising are~     being compared, exercise bouts involving intermittent exercise and exercise completed all at~     once, but at a very high intensity.~   "
171953|NCT01314560|"~     Lowe syndrome is associated with mutations in the OCRL1 gene, which encodes OCRL1, a~     phosphatidylinositol-4, 5-bisphosphate (PtdIns(4, 5)P (2))5-phosphatase. PtdIns(4, 5)P2, a~     substrate of OCRL1, is an important signaling molecule within the cell. An abnormal rate of~     hemorrhagic events was found in a retrospective clinical survey, suggesting platelet~     dysfunction.~      The main objective of the study is to confirm the presence of platelet dysfunction in Lowe~     syndrome and to characterize this abnormality.~   "
171954|NCT01314547|"~     Susceptibility to SPA has been shown to be largely genetically determined. The objective of~     this study was to prospectively investigate the impact of several environmental factors on~     disease activity.~   "
171955|NCT01314534|"~     Create a census for the duration of the search for French patients with SK~        -  determining epidemiological and morphological parameters,~        -  determine the true frequency of clinical symptoms and identify new ones,~        -  identify complications of the disease to improve the care of patients in the hope of a~          better prognosis of the disease and~        -  performing a radiological study by Voxel based morphometry MRI type (N. BODDAERT,~          HOPITAL Necker-Enfants Malades, Paris)~      Perform genetic research to identify the genetic bases of SK using CGH-array (Comparative~     Genomic Hybridization )~   "
171956|NCT01314521|"~     The purpose of this study is to examine clinical characteristics of Korean adolescents with~     depression who have suicidal ideation and behavior. We formulate those hypotheses.~        1. Being bullied in peer relationships, excessive use of internet, excessive~          extra-curricular tutoring, sexual abuse in childhood, physical abuse and emotional~          neglect are risk factors of suicide in adolescents.~        2. Depression of parents and negative child-rearing attitude are risk factors of suicidal~          ideation and behavior in adolescents.~        3. Emotional quotient (EQ) and resilience of adolescent are protective factors of suicide.~   "
171957|NCT01314508|"~     A major consequence of chronic liver disease in childhood is growth failure. This is because~     a chemical essential for growth called growth factor is created in the liver. Lack of~     response to growth hormone in people with chronic liver disease is characterized by high~     levels of growth hormone and low levels of growth factors. This growth hormone resistance is~     reflected in a variety of factors including insulin resistance and low nutritional intake.~     Unfortunately, growth hormone therapy has no effect for children with liver disease. In~     addition, failure of normal growth or malnutrition makes liver disease even worse in~     children, and growth hormone therapy is not likely to reverse this. A lack of proper~     nutrition is associated with hospitalizations and frequent complications. Poor growth is a~     predictor of poor outcomes after liver transplantation. Thus the management of children with~     liver disease remains a challenge. Children who have successful orthotopic liver transplants~     (OLT) show much improvement in some aspects of growth, including skin fold thickness, mid-arm~     circumference, and normalization of growth factor levels. However, some studies have recently~     reported that the growth of 15-20% of children remains poor even after a liver transplant.~     This can be explained by persistent abnormalities in growth factors after transplant.~      Growth factor was found to be a good tool for prognosis in patients with chronic liver~     disease. Studies showed that patients with liver cirrhosis and growth factor levels below~     normal values showed lower long-term survival rates compared with patients who had above~     normal values. This suggests that growth factor can be a good predictor of survival and early~     marker of poor liver function. In this case, aggressive feeding may modestly improve growth~     factor levels leading to improved growth but it is unlikely that effects will be optimal. The~     investigators propose that growth factor administration may have a positive effect that leads~     to better growth which is a major predictor of good outcome. To date, no reports study the~     use of growth factor in children with chronic liver disease. This study proposes to examine~     the effect of growth factor therapy in childhood chronic liver disease.~   "
171958|NCT01314495|"~     Will Abatacept reduce priming of the hair follicle specific T cells and thereby reduce hair~     follicle associated infiltration and improve hair growth.~      This is a double blind placebo controlled study to test the safety and efficacy of Abatacept~     in the treatment of 64 subjects diagnosed with alopecia totalis or alopecia universalis.~     Subjects will be randomized 1:1 to the placebo or treatment arm and will receive 6 months of~     treatment with the study medication or placebo, followed by a 6 month observational period.~   "
171959|NCT01314482|"~     In about half the patients who have an open chest surgery there is persistent severe pain in~     the chest. The investigators are examining whether minocycline, a commonly used antibiotic,~     will prevent pain. Minocycline blocks the activity of immune cells which the investigators~     believe are responsible for prolonging the pain.~   "
171960|NCT01314469|"~     The aim of this study is to determine if macular edema is associated with less visual~     function and quality of live in patients with intermediate uveitis~   "
171961|NCT01314456|"~     Prostate biopsy is performed by multiple consecutive biopsy needle insertion into the~     prostate gland under a trans-rectal ultrasound probe guidance.~      Today, the performing physician navigates the needle using a momentary 2D ultrasound image~     (longitudinal and transverse B mode) without any record of the full prostate boundaries or~     previous biopsies' location.~      This study's Objectives are to record the trans-rectal biopsy procedure including the initial~     scan and the needle biopsy location and to modulate a 3D model of the prostate with accurate~     display the locations of the various biopsies taken during the procedure.~   "
171962|NCT01314443|"~     Cigarette smoking is a significant risk factor for cardiovascular disease (CVD) and is the~     leading cause of premature mortality in the US. The detrimental effects of smoking on~     vascular dysfunction are attributed to the effects of smoke itself and the inflammatory~     responses it induces. Smoking cessation restores vascular function by alleviating these~     stress responses. However, smoking cessation with nicotine replacement therapy (NRT), the~     prevailing approach to mitigate tobacco dependence, fails to allow full restoration of~     vascular function. Thus, a critical public health problem exists to understand how NRT~     prevents restoration of vascular function and how these NRT-mediated impairments can be~     overcome by using gamma-tocopherol (g-T) as an innovative co-therapy. The objective of this~     study is to conduct a clinical intervention trial that aims to reduce CVD risk by defining~     how smoking cessation and g-T restore vascular function. The hypothesis is that smoking~     cessation and dietary g-T supplementation will synergistically restore smoking-induced~     impairments in vascular function by ameliorating oxidative/nitrosative stress responses, and~     that g-T will facilitate full restoration of vascular function otherwise precluded by NRT. A~     placebo-controlled, g-T intervention study will be conducted in cigarette smokers undergoing~     nicotine-free or NRT smoking cessation. Prior to and after 24 h and 7 days of placebo or g-T~     administration, vascular function will be evaluated using a non-invasive ultrasound technique~     and an array of antioxidants and biomarkers for vascular inflammation and~     oxidative/nitrosative stress responses will be assessed. Collectively, these studies will~     help identify how vascular function is regulated in individuals undergoing smoking cessation,~     and whether g-T can be used as a strategy to better improve vascular function during smoking~     cessation.~   "
171963|NCT01314417|"~     BACKGROUND:~      Uveitis comprises of a group of diseases associated with inflammation of the eye that can~     lead to vision loss. Some people with uveitis also have macular edema (swelling of the retina~     at the back of the eye). Uveitis and macular edema are treated with medications and sometimes~     surgery, but treatment does not always prevent vision loss. Previous research has shown that~     injections of methotrexate into the eye of people with eye disease other than uveitis can~     help relieve the inflammation, or swelling, that causes macular edema and can slow visual~     loss. However, it has not yet been approved as a treatment for macular edema associated with~     uveitis.~      OBJECTIVES:~      To evaluate the safety and effectiveness of methotrexate injections as a treatment for~     macular edema associated with uveitis.~      ELIGIBILITY:~      Individuals at least 18 years of age who have been diagnosed with uveitis and macular edema~     in at least one eye.~      DESIGN:~        -  This study requires at least nine visits to the National Eye Institute study clinic over~          a period of 6 months (24 weeks).~        -  Participants will be screened with a physical and ophthalmic examination, medical~          history, blood and urine tests, and additional eye and other tests as needed.~        -  Participants will receive a methotrexate injection in a selected treatment eye. After~          the injection, participants will receive antibiotic eye drops to place in the eye three~          times a day for the 3 days following the injection, leucovorin (folic acid) drops to~          place in the eye four times a day for 1 week following the injection, and a dose of~          folic acid to be taken by mouth the day after the injection.~        -  Participants who tolerate the initial injection may continue to receive injections in~          their study eye every month for 6 months. After 6 months, participants who show~          improvement from the injections may be evaluated to receive additional injections every~          4 to 8 weeks until researchers end the study.~   "
171964|NCT01314404|"~     The Global Alliance to Immunize Against AIDS Vaccine Foundation (GAIA Vaccine Foundation or~     GAIA VF) proposes to carry out a Knowledge, Attitudes, and Practices (KAP) study in~     conjunction with a Willingness To Participate (WTP) evaluation to establish the prevalence of~     cervical dysplasia, to and perform Human Papillomavirus (HPV) subtyping studies in Bamako and~     in Sikoro-Mekin, a village within the perimeter of Bamako, the capital of Mali, West Africa.~     Working with experienced collaborators, we propose to carry out an HPV prevalence study~     (among women diagnosed with cervical cancer at Hôpital Touré), coupled with a study of~     Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV~     vaccine study among individuals living in Sikoro-Mekin. These studies will lay the groundwork~     for a phase IV study of Gardasil® at the same site, which would be an important step forward~     for West Africa.~   "
171965|NCT01314391|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research study is studying biomarkers in blood and tumor tissue samples from~     patients with Wilms tumor.~   "
171966|NCT01314378|"~     Dependence on tobacco derived nicotine is a major public health problem. Substance users who~     complete training in mindfulness subjectively report increased patience and improved motor~     control over their impulses. Yet, no studies have tested this perceived benefit with~     behavioral measures of impulse control. The investigators are conducting a randomized~     controlled clinical trial, which compares Cognitive-Behavioral Therapy and Mindfulness~     Training for tobacco smokers, using behavioral measures to investigate the effects of~     mindfulness training on impulsivity and inhibitory control.~   "
171967|NCT01314365|"~     The purpose of the protocol is to determine typical patient response to Dysport in the~     treatment of adult cervical dystonia (CD).~   "
171968|NCT01314352|"~     The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's~     Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fed~     conditions.~   "
171969|NCT01314339|"~     The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's~     Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fasting~     conditions.~   "
171970|NCT01314326|"~     The specific aims of the clinical studies are to:~        1. Predict the development of glaucomatous visual field (VF) abnormality in glaucoma~          suspects and pre-perimetric glaucoma patients based on anatomic abnormalities detected~          by advanced imaging.~        2. Predict the development of glaucomatous VF abnormality in glaucoma suspects and~          pre-perimetric glaucoma patients based on anatomic changes detected between successive~          advanced imaging tests.~        3. Determine the sensitivity and specificity of glaucoma diagnosis based on advanced~          imaging tests.~   "
171971|NCT01314313|"~     The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN~     XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended~     for use in patients with symptomatic, calcific, severe aortic stenosis.~   "
171972|NCT01314300|"~     Lidocaine 5% plaster (VERSATIS® 5%) showed its efficacy and safety in the post-herpetic~     zoster adult pains. This treatment is recommended in first intention in adult neuropathic~     pains with allodynia.~      The purpose of this study is to assess efficacy and safety of lidocaine 5% plaster (VERSATIS®~     5%) in the pediatric neuropathic pains and vasoocclusive sickle cell crises pains.~   "
171987|NCT01314105|"~     This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to~     treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in~     patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma~     or primary peritoneal cancer.~   "
171973|NCT01314287|"~     General anaesthesia causes small areas of lung to collapse (referred to as atelectasis) and~     many strategies are used to prevent or reverse this, but these strategies only temporarily~     improve lung function and do not persist into the post anaesthesia care unit (PACU) where~     atelectasis may still be present. One possible explanation for this is that coughing~     occurring at the end of the anaesthesic may cause atelectasis to occur. Over 70% of patients~     cough when their breathing tube is removed as they emerge from the anaesthetic, and our~     hypothesis is that the presence of the breathing tube prevents a normal cough from occurring~     and may worsen atelectasis. This study will use alveolar-arterial oxygen difference (AaDO2)as~     a measure of how well the lungs are oxygenating the blood. This will be measured 30 minutes~     before the end of the anaesthetic as a control measure of the patient's lung function, and~     again 60 minutes after the patient has woken up, and the change compared with the amount of~     coughing observed as the patient emerges from the anaesthetic.~   "
171974|NCT01314274|"~     In a case series intranasal submucosal bevacizumab has been shown to reduce epistaxis in~     patients suffering from Hereditary Haemorrhagic Telangiectasia together with KTP Laser~     therapy. The aim of this study is to evaluate the effectiveness of submucosal intranasal~     bevacizumab compared to placebo in a randomized double blind trial setting.~   "
171975|NCT01314261|"~     The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid~     virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in~     combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone~     (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected~     participants.~   "
171976|NCT01314248|"~     The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway~     maintenance during routine anesthesia and as a conduit for tracheal intubation for patients~     with a difficult airway. The investigators goal for this study is to compare the performance~     of the ILA with the current standard of care the standard LMA during routine anesthesia.~   "
171977|NCT01314235|"~     Clonidin works as a presynaptic agonist of alpha-sympathomimetic receptors of the brain but~     also in many other tissues. It is part of balanced anesthesia in general anesthesiology as~     well as a sedastive agent in intensive care units, but also serves as a third-line agent in~     many psychiatric diseases including ADHD, schizophrenia and PTSD.~      The investigators want to show whether clonidin has an procoagulatoric effect on thrombozytes~     of patients under double anticoagulaotirc treatment with ASS and clopidogrel. The~     investigators will use a flowcytometric assay to determine activation of thrombozytes when~     they come into contact with clonidine in vitro as well as Multiplate analyses to determine~     activation of thrombozytes, either thrombin.induced aggregation, ADP-induced aggregation or~     arachidonic acid-induced aggregation of thrombozytes.~   "
171978|NCT01314222|"~     The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared~     to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).~   "
171979|NCT01314209|"~     The purpose of this study is to determine dexmedetomidine pharmacokinetics during continuous~     renal replacement therapy on critically ill patients.~   "
171980|NCT01314196|"~     The aim of this study was to evaluate the influence of progressive resistance training of the~     biceps in shoulder rehabilitation in patients with subacromial impingement syndrome (SIS).~      Method: a randomized controlled clinical trial, with analysis intention-to-treat, approved by~     the Ethics and Research (1019/08), containing sixty patients of both sexes, SIS, evaluated at~     the initial time (T0), with 45 days (T45) and 90 days of treatment (T90). We analyzed the~     pain at rest (VAS), range of shoulder movement, strength, function by The Disabilities of~     Arm, Shoulder and Hand (DASH) and quality of life by Short Form-36 (SF-36) and Western~     Ontario Rotator Cuff Index (WORC). They recommended the use of NSAIDs and analgesics in the~     presence of pain exacerbated, every eight hours. Study groups will perform therapeutic~     exercises for the shoulder and scapula stabilizers. In the experimental group associate~     progressive resistance training of the biceps.~   "
171981|NCT01314183|"~     The overall aim of the project is to examine the clinical and cost-effectiveness of utilizing~     booster sessions(periodic face-to-face follow-up appointments that take place several weeks~     or months following discharge from the supervised therapy program designed to review the~     patient's current rehabilitation program, troubleshoot any problems with the program, and~     make recommendations for program progression or modification) in the delivery of exercise~     therapy, and supplementing exercise therapy with manual therapy techniques(manually applied~     treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue~     manipulations, passive stretching and range of motion). The investigators will do this in a~     randomized, multi-center, clinical trial. The investigators hypothesize that adding manual~     therapy techniques will be more clinically effective than exercise alone and that using~     booster sessions will maintain longer term clinical effects and be more cost-effective than~     not using booster sessions.~   "
171982|NCT01314170|"~     Study clinical multicenter, phase III, open-label, prospective character to evaluate the~     efficacy and safety Susanna Implant in patients with refractory glaucoma.~   "
171983|NCT01314157|"~     Isostretching is effective in treating chronic back pain to improve pain, quality of life and~     functional capacity.~   "
171984|NCT01314144|"~     Axillary clearance forms part of the surgical armamentarium for the treatment of breast~     cancer. Although the introduction of sentinel lymph node mapping and dissection has allowed~     for the decreased use of axillary clearance, it remains a frequently performed operation.~     Axillary clearance is associated with moderate postoperative pain.~      We hypothesize that a continuous wound infusion of 0.2% Bupivacaine at 4ml/hr would provide~     superior analgesia, when compared to standard opioid-based analgesia, in patients undergoing~     axillary lymph node clearance surgery.~   "
171985|NCT01314131|"~     The purpose is to evaluate patients' interests (patients in nursing home). Moreover the study~     aims to evaluate whether an activity for which the patient is interested in, allows a better~     involvement and stimulation.~   "
171986|NCT01314118|"~     The purpose of this study is to show that abiraterone acetate plus prednisone added to the~     current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific~     antigen (PSA) and prolongs the time until it is evident that the cancer has grown.~     Additionally, safety information about abiraterone acetate in combination with prednisone~     will be collected. This will include looking at what side effects occur, how often they~     occur, and for how long they last.~   "
171988|NCT01314092|"~     Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into~     myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal~     fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown~     efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the~     investigators would apply autologous adipose stem cells on complex perianal fistula to~     evaluate their efficacy and safety.~   "
171989|NCT01314079|"~     This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of~     Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical~     trial.~   "
171990|NCT01314066|"~     This study aims to test the effectiveness of a single intravenous (IV, through the vein) dose~     of the study drug, bevacizumab (Avastin), in preventing/reducing the development of Acute~     Respiratory Distress Syndrome (ARDS), in patients with severe sepsis, who are at high risk~     for developing ARDS. ARDS is a lung disease caused by a lung injury that leads to lung~     function impairment. The condition the patient has,severe sepsis, is a medical condition~     associated with an infection characterized as an immune system inflammatory response~     throughout your whole body that can lead to organ dysfunction, low blood pressure or~     insufficient blood flow to one or more of your organs.~   "
171991|NCT01314053|"~     Daptomycin was approved since 2005 in Taiwan and have been studied and published in west~     countries. After review the published papers, the few data were described in the Asian~     countries or Taiwan. The objectives of this study are to evaluate the efficacy and safety of~     daptomycin for the treatment of Gram-positive infections under actual conditions of use, and~     to understand other information concerned with daptomycin prescription. This study represents~     an opportunity for acquiring real world data on daptomycin usage, and may provide physicians~     in Taiwan with the information of characteristic of the patients receiving daptomycin and to~     evaluate outcomes. It also provides a means to identify safety signals that emerge with~     clinical usage.~   "
171992|NCT01314040|"~     Results from observational studies suggest a small beneficial association between protein and~     blood pressure that may be mainly attributable to the intake of protein from plant sources.~     In epidemiological studies biomarkers of dietary intake are useful to estimate intake more~     reliably. Dietary studies using biomarkers of protein intake generally show stronger~     associations with health outcomes. However, data on biomarkers for specific types of protein~     (e.g. from dairy, meat, grain and legumes) are scarce. Therefore the purpose of this study is~     to identify new biomarkers for the intake of protein from meat, dairy and grain. In addition~     the secondary purpose is to investigate whether intake of protein from these sources~     influences kidney filtration rate and urinary acid excretion differentially.~   "
171993|NCT01314027|"~     The outcome of patients with resected pancreatic cancer has significantly been improved by~     adjuvant chemotherapy. However, a large proportion of patients cannot receive adjuvant~     chemotherapy due to surgical complications. Neoadjuvant chemotherapy has been shown to be~     safe and effective and can be applied to all patients. This study should test neoadjuvant~     chemotherapy in a randomized manner.~      Patients with resectable cytologically proven adenocarinoma of the pancreatic head are~     randomized to arm A or B.~      Patients randomized to arm A receive an 8-week neoadjuvant chemotherapy with~     gemcitabine/oxaliplatin followed by surgery. Thereafter, all patients receive adjuvant~     gemcitabine for six months.~      Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in~     arm A.~      The primary study-endpoint is the recurrence-free survival. Tumor recurrence are determined~     by computed tomography in a defined protocol.~        -  Trial with medicinal product~   "
171994|NCT01314014|"~     The purpose of this study is to determine whether Amplimexon (imexon for injection) is~     effective in the treatment of indolent and aggressive lymphomas that have progressed after~     treatment with standard therapies.~   "
171995|NCT01314001|"~     The purpose of this research program is to understand how a biomarker called the nicotine~     metabolite ratio (also referred to as NMR) may influence a smoker's ability to quit smoking.~   "
171996|NCT01313988|"~     Plant sterols and fish fatty acids are known to affect the blood lipid profile. This~     randomized, double-blind, placebo-controlled, parallel efficacy study is designed to~     investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of~     plant sterols and different doses of fish fatty acids when combined in a spread format.~   "
171997|NCT01313975|"~     During the course of their acute illness patients with subarachnoid hemorrhage and severe~     traumatic brain injury often develop disturbances in their fluid balance and electrolyte~     homeostasis. These shifts are associated with worse outcome and increased morbidity.~      The aim of this observational study is to systematically analyze the incidence,~     characteristics, potential diagnostic markers and predisposing factors of such disturbances.~     The investigators hypothesize that many disturbances cannot be classified with a standard~     diagnostic approach and that variable fluid management contributes to their pathophysiology.~      Patients will be closely monitored clinically and the exact fluid and electrolyte balances~     will be recorded. Treatment decisions are within the bedside physicians responsibility.~     Baseline fluid management is standardised. No interventions are planned. The observation~     period equal the duration of ICU stay.~   "
171998|NCT01313962|"~     The purpose of this study is to evaluate the safety and pharmacokinetic profile of~     flufirvitide-3 nasal spray in healthy subjects.~   "
171999|NCT01313949|"~     The investigators hypothesize that a training course to people with diabetes on peer support~     and empowerment will improve their glycemic parameters, knowledge on diabetes and level of~     self efficacy. This group of trained patients (peer leaders) should be competent to teach and~     help other patients with diabetes through peer support and empowerment on better self~     management of their diabetes.~   "
172000|NCT01313936|"~     This is a pilot study to determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are~     tolerable when given with irinotecan/vincristine on a one week schedule to children and young~     adults with high-risk refractory/relapsed neuroblastoma.~   "
172001|NCT01313923|"~     The purpose of this research is to study alternative treatments for the skin disease~     pemphigus (a rare autoimmune blistering disorder of the skin) by using sirolimus, an~     immunosuppressive drug. Immunosuppressive drugs inhibit or prevent the activity of the immune~     system and are commonly used to treat autoimmune diseases, inflammatory diseases, and organ~     transplantation rejection.~   "
172003|NCT01313897|"~     The purpose of this study is to determine the therapeutic efficacy of the exp-NK cell therapy~     in research participants with relapsed high risk MM [defined as gene expression profile (GEP)~     70 gene score ≥0.66 and/or metaphase chromosomal abnormalities and/or high LDH ≥ 360U/L] by~     establishing the (near) complete response rate. Response rate will be compared to case~     matched historical controls (patients who relapsed on Total Therapy 2 or 3 with high-risk MM~     defined as above). Disease-free survival and overall survival will be captured but are not~     primary or secondary endpoints.~   "
172004|NCT01313884|"~     The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care~     chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature~     we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma~     using Irinotecan and Temozolomide in addition to standard chemotherapy.~   "
172005|NCT01313871|"~     The study will assess the disease severity and treatment patterns of rheumatoid arthritis in~     Eastern European, Middle Eastern, and North African countries.~   "
172006|NCT01313858|"~     This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid~     arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to~     evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice~     conditions as assessed by the incidence and type of (serious) adverse events and changes in~     clinical status of participants as assessed by clinical parameters.~   "
172007|NCT01313845|"~     A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait~     freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's~     disease.~        -  administration of IV amantadine or normal saline for 5 days, 2 times a day while keeping~          current oral anti-parkinsonian medications unchanged~        -  follow-up after administration of IV amantadine for 4 weeks~        -  allocation ratio of amantadine:normal saline is 2:1~   "
172008|NCT01313832|"~     Intraoperative myocardial and pulmonary protection is important for better outcome after~     cardiac surgery. Ischemic preconditioning is one of organ protective strategies against~     ischemia-reperfusion injury by applying brief ischemia to the target organ before a~     subsequent critical ischemia, and its effect has been confirmed. However, its clinical~     application is not easy because ischemic insult may aggravate the function of vulnerable~     organ.~      On the other hand, remote ischemic preconditioning (RIPC) is another protective approach by~     applying ischemia to other less vulnerable organ such as skeletal muscle before critical~     ischemia-reperfusion injury to heart. The effect of RIPC has been well demonstrated in adults~     and children. However, Little is known about the effect of remote ischemic precondition on~     the pediatric myocardium to ischemia and reperfusion injury. The effect of RIPC on the~     children remains to be further evaluated because the degree of ischemia-reperfusion injury is~     different according to age, cardiac pathology and cyanosis. In addition, the previous report~     on children dealt with a diverse range of congenital heart defects with a wide age range. The~     purpose of this study was to evaluate the effect of RIPC on myocardial and pulmonary~     protection in infants with pulmonary hypertension who need repair of simple ventricular~     septal defect.~   "
172009|NCT01313819|"~     Tp determine the effect of IV amantadine on dopaminergic-drug-resistant freezing of~     gait(FOG)in patients with Parkinson`s disease~   "
172010|NCT01313806|"~     To determine if low level magnetic fields can help to improve memory in patients diagnosed~     with Alzheimer's disease.~   "
172011|NCT01313793|"~     The study will determine if bioequivalence can be claimed between the proposed~     commericializable formulation and the current clinical formulation. Specifically, if the 90%~     confidence intervals of the ratio for Area under the curve (AUC) and maximum concentration~     (CMax) are within the 80%-125% guidance limits.~   "
172012|NCT01313780|"~     Objectives:~      To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity~        1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours~          obtained each evening) within 4 weeks~        2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and~          frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need~          of laxative use and Adverse events~   "
172013|NCT01313767|"~     This study is a randomized, double blind, multi-center, active drug controlled, phase III~     clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of~     post stroke upper limb(wrist, finger, thumb) spasticity~      Approximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single~     treatment of intramuscular Investigational product up to 360U. The subjects will be observed~     every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth Scale~     (MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or~     caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change~     from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth~     Scale. Safety parameters will also be measured including adverse events, vital signs and~     clinical laboratory tests (haematology, serum chemistry and urinanalysis).~   "
172014|NCT01313754|"~     The purpose of this study is to compare different skin closure materials for the~     transobturator suburethral sling procedure. Currently the investigators are using monocryl~     suture material as the standard for skin closure. This material has anecdotally show to be~     very irritating to patients who have had this type of surgery. Our study will compare the~     monocryl suture material with vicryl (polyglactin 910) and dermabond (2-octyl cyanoacrylate)~     skin glue. The investigators believe that vicryl suture material will be superior in comfort~     when compared to monocryl and dermabond for this type of procedure.~   "
172015|NCT01313741|"~     Two hundred patients will be analyzed both clinically (via validated outcomes measures) and~     radiographically (via 2 sets of standard radiographs) to determine the survival and degree of~     bone in growth of a novel all polyethelene glenoid component used in a standard FDA approved~     shoulder arthroplasty system.~   "
172016|NCT01313728|"~     This study is to see if there's any difference in the amount of facial irritation when two~     acne products are used together on one side of the face, compared to one acne treatment~     product used alone on the other side of the face. All people participating in this trial will~     be required to return to the same study center every weekday for two weeks for the~     investigator to check for irritation on the face and to have the products applied - on~     weekends they will have to put them on at home. If one side of the face is more irritated~     than the other side, a picture will be taken as well.~   "
172017|NCT01313715|"~     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused~     by viruses that belong to the enterovirus genus of the picornavirus family. Although most~     HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71~     (EV71) can present with a high rate of neurological complications, including~     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by~     EV71 has become a major emerging infectious disease in Asia and the highly pathogenic~     potential of EV71 clearly requires the attention of world medical community.~      Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China,~     this clinical trial phase Ib is armed to evaluate safety in Chinese healthy children (from 13~     to 60 months old) and infants (from 6 to 12 months old) and also provide the evidences for~     the EV71 vaccine immunogenicity and the probable immunizing dose.~   "
172018|NCT01313702|"~     The purpose of this study is to determine whether a polipill improved the compliance with~     treatment compared to usual care that use two or more drugs,in patients at high~     cardiovascular risk or previous cardiovascular disease.~   "
172019|NCT01313689|"~     The purpose of this study is to confirm the clinical benefit observed in the pivotal~     registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP)~     required that a randomized study be conducted in CLL patients with bulky~     fludarabine-refractory disease as a specific obligation for grant of conditional approval for~     ARZERRA™ in the European Union (EU). This study will compare ofatumumab with the physicians'~     choice of therapy.~   "
172020|NCT01313676|"~     The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival~     in patients with chronic obstructive pulmonary disease with a history of or increased risk of~     heart disease.~   "
172021|NCT01313663|"~     This is a Phase II, randomized, open-label, multi-center study in advanced (Stage IVA and IVB~     subjects per the International Association for the Study of Lung Cancer (IASLC) 2009 Lung~     cancer staging schema) non-squamous NSCLC subjects comparing pazopanib relative to pemetrexed~     in the maintenance setting. Subjects should have completed 4-6 cycles of induction therapy~     with carboplatin + pemetrexed or cisplatin + pemetrexed and have had Stable Disease (SD),~     Partial Response (PR) or Complete Response (CR) as the best response to be enrolled into the~     study. The primary objective is to estimate the hazard ratio of progression free survival~     (PFS) in advanced NSCLC subjects given maintenance therapy of pazopanib (Arm A) relative to~     pemetrexed (Arm B). The secondary objectives are: overall survival, response rates, safety~     and tolerability. A total of approximately 200 subjects will be enrolled and randomized in a~     1:1 ratio. Safety and efficacy assessments will be regularly performed on all subjects.~   "
172022|NCT01313650|"~     This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719~     Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a~     Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who~     meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period~     followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a~     total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will~     be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal).~     The total duration of subject participation in the study will be approximately 27 weeks. A~     subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter~     monitoring during the study and provide serial blood samples for pharmacokinetic analysis.~     Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from~     non-subset subjects. The primary measure of efficacy is clinic visit trough~     (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by~     adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter~     monitoring (subset only).~   "
172023|NCT01313637|"~     This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719~     Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a~     Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who~     meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period~     followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a~     total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will~     be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal).~     The total duration of subject participation in the study will be approximately 27 weeks. A~     subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter~     monitoring during the study and provide serial blood samples for pharmacokinetic analysis.~     Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from~     non-subset subjects. The primary measure of efficacy is clinic visit trough~     (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by~     adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter~     monitoring (subset only).~   "
172024|NCT01313624|"~     The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and~     gram-negative airway infection. Participants received two 28-day courses of either Aztreonam~     for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a~     28-day off-drug period. Following the two blinded courses, all participants received a 28-day~     course of open-label AZLI then were followed for an additional 56 days.~   "
172025|NCT01313611|"~     The objective of this study is to evaluate the complete response rate after a short induction~     treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old)~     patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and~     without high tumor burden.~      This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction~     schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8,~     Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30~     Maintenance schedule: 12 infusions of rituximab, each 8 weeks~   "
172026|NCT01313598|"~     The purpose of the study is to determine the safety and tolerability of GLPG0187 administered~     through continuous intravenous infusion and to explore its preliminary clinical efficacy in~     patients with solid tumors.~   "
172027|NCT01313585|"~     This study will compare the absolute and relative effectiveness of asthma management in~     patients on inhaled corticosteroid (ICS) maintenance therapy as Easi-breathe® (EB) -~     beclometasone dipropionate (BDP) breath-actuated inhaler (BAI) - and as-needed (prn) reliever~     medication (short-acting beta2-agonist [SABA] therapy) via either a BAI (i.e. Easi-breathe®~     [EB] salbutamol) or via a pressurised metered dose inhaler (MDI) (e.g. MDI salbutamol).~   "
172028|NCT01313572|"~     The purpose of this study is to see whether apadenoson is as effective as adenosine when used~     as a pharmacological stress agent in myocardial SPECT-imaging (SPECT-MPI)to detect defects in~     the supply of blood to the heart muscle (myocardial perfusion defects). The study will also~     look at whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.~   "
172029|NCT01313559|"~     This is an open label randomized phase II study for prostate cancer patients who have disease~     progression after hormonal therapy. SOM230 LAR (Pasireotide) binds to its receptor of~     prostate cancer cells and can prevent them from growing. Everolimus works by targeting a cell~     survival factor in prostate cancer. The combination of these drugs may work better for the~     treatment of prostate cancer without toxic chemotherapy. Patients will receive either SOM230~     LAR (group A) or SOM230 LAR in combination with Everolimus (group B).~   "
172030|NCT01313546|"~     Objective: Continuous nerve block (freezing the nerve) is needed for knee replacement surgery~     to reduce pain, increase rehabilitation and discharge patients home fast. A lot of time,~     money and hospital resources are invested in inserting these catheters. The aim of this study~     is to compare two end points used for insertion of continuous femoral nerve block and to see~     which one results in fewer failures on the surgical ward.~      Methodology: Patients having total knee replacement surgery will be recruited in this study.~     Patients will be randomized into two groups. The continuous femoral nerve block catheter will~     be inserted using ultrasound and nerve stimulation with two different end points (certain~     muscle contraction).~      Patients will be followed on day 1 and 2 after surgery to observe which catheter fails, how~     much pain the patient suffers and how much painkiller the patients used.~   "
172031|NCT01313533|"~     The purpose of this study is to study the effects of polyarginine treated vein grafts on~     graft patency for patients undergoing coronary artery bypass surgery.~   "
172032|NCT01313520|"~     This is a study to compare the effect of infliximab versus placebo on synovial inflammation~     as measured by dynamic contrast enhanced (DCE)-MRI of one wrist. The primary hypothesis is~     that over 14 weeks of therapy, the change from baseline in the volume transfer rate in~     enhancing synovium is larger due to treatment with infliximab than with placebo.~   "
172033|NCT01313507|"~     This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III~     study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks,~     continuing the patient's infusion interval in the main study NCT01012323 [NGAM-01]) for 3~     months. The primary objective of the study was to assess the safety and tolerability of high~     infusion rates of NewGam.~   "
172034|NCT01313494|"~     The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg~     Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.~   "
172035|NCT01313481|"~     The study aims to assess the effect on functional balance of Otago exercise performed as home~     exercise versus group exercise. The investigators hypothesize that Otago exercise is more~     effective performed as group exercise than home exercise.~   "
172036|NCT01313468|"~     It has been reported that obese individuals are seated 2 ½ hour more than lean individuals~     and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between~     equal size people due to different occupational and leisure time activities. The primary aim~     of the study is to investigate if 10 weeks of exercise training increase NEAT in sedentary~     men.~      Subject will be randomized to three different training intervention, with 3 exercise session~     each week for 10 weeks. NEAT will be measured using an activity sensor and recorded over a 7~     day period both before and after training.~   "
172037|NCT01313455|"~     Background:~      - Polycystic ovarian syndrome (PCOS) is a group of disorders related to problems with the~     secretion of certain hormones, which can lead to reproductive and other issues in women.~     Frequent complications of PCOS include irregular menstruation, development of ovarian cysts,~     and insulin resistance. The adrenal glands, which sit on top of the kidney, are involved in~     the production of certain hormones and the regulation of steroid levels in the blood, and may~     be affected in women with PCOS. Researchers are interested in studying possible connections~     between the adrenal glands and PCOS in young women who have been diagnosed with PCOS and~     healthy volunteers with normal menstrual function.~      Objectives:~      - To investigate possible connections between adrenal gland steroid hormone secretion and~     polycystic ovarian syndrome.~      Eligibility:~        -  Women between 16 and 29 years of age who have been diagnosed with PCOS, or who are~          healthy volunteers with normal menstrual function.~        -  Participants must be willing to discontinue the use of oral contraceptives or any other~          medications that alter steroid hormone production for at least 1 month before the start~          of the study.~      Design:~        -  Participants will be screened with a physical examination, medical history, and blood~          and urine tests. All participants will also have a pelvic (ovarian) ultrasound.~        -  All participants will be admitted to the hospital for a 1-week testing period, which~          will involve the following tests:~        -  Regular blood draws for two 2-hour periods (late evening and early morning) to measure~          hormone levels~        -  Fasting blood draws with a dose of corticotropin to test the body's adrenal function~        -  Hormone level measurement following regular doses of dexamethasone (a drug that controls~          the function of the adrenal gland)~        -  Daily urine collection for 6 days.~        -  Other studies, such as imaging studies of the adrenal glands, may be conducted as~          required by the study researchers.~   "
172038|NCT01313442|"~     Background:~      - Gastrointestinal cancers can occur in the throat, stomach, gallbladder, liver, pancreas,~     and colon. Researchers are interested in evaluating how active the immune system is in trying~     to fight the cancer by studying blood and tumor tissue donated from individuals who have been~     diagnosed with gastrointestinal cancers.~      Objectives:~      - To collect blood and tumor samples from individuals who have been diagnosed with~     gastrointestinal cancers in order to study the immune system s response to the cancer.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with throat, stomach,~     gallbladder, liver, pancreatic, or colon cancer, and are scheduled to be treated at the~     National Institutes of Health.~      Design:~        -  The study will require at least one but no more than four visits to the National~          Institutes of Health Clinical Center.~        -  Participants will be screened with a physical examination and medical history, and will~          provide a baseline blood sample for study.~        -  Participants will provide additional blood samples 2 and 4 months after the baseline~          sample, as well as a final sample at the completion of the treatment protocol.~        -  Participants will provide tumor tissue samples only if they undergo a surgical procedure~          related to the treatment for their gastrointestinal cancer.~        -  No treatment will be provided as part of this protocol.~   "
172039|NCT01313429|"~     Background:~      - Certain types of cancers, including sarcoma and melanoma, have specific antigens (protein~     molecules) on their surfaces. Research has shown that producing an immune reaction to these~     antigens may be able to keep tumors from growing by encouraging the immune system to destroy~     the tumor cells. By creating a vaccine that contains antigens similar to those found on the~     cancer cells, researchers hope to cause an immune reaction that targets the cancer cells.~     However, more research is needed to determine the safety and effectiveness of this type of~     vaccine treatment.~      Objectives:~      - To determine whether a tumor cell vaccine, given to individuals who have had surgery to~     remove malignant tumors from the chest, can cause an immune reaction that will prevent the~     tumors from coming back.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with cancer that has spread to~     the lungs, pleura, or mediastinum, and have recently had surgery to remove tumors in the~     chest.~      Design:~        -  Participants will be screened with a physical examination and medical history, as well~          as blood tests and imaging studies.~        -  Participants will have the option to have leukapheresis to collect white blood cells for~          studies on how the body is responding to the vaccine. Participants who agree to have~          this procedure will have it before the start of treatment and after the sixth and eighth~          vaccines.~        -  Seven days before the first vaccine, participants will receive the chemotherapy drugs~          celecoxib and cyclophosphamide to take twice a day at home.~        -  Participants will receive the experimental vaccine as an injection in the thigh or arm,~          and may receive it in two shots depending on how many cells are in each vaccine.~          Participants will receive a diary to monitor medication doses and side effects, as well~          as additional cyclophosphamide and celecoxib to take at home as directed by the study.~        -  Participants will have one vaccine every month for 6 months, and will have regular blood~          tests and imaging studies. After the sixth vaccine, participants who have successfully~          responded to the treatment will have two additional vaccines given 3 months apart.~        -  After the eighth vaccine, participants will have followup visits every 3 months for 1~          year and then every 6 months for up to 4 years.~   "
172040|NCT01313416|"~     Background:~        -  In 2009, 49,096 patients were diagnosed with pancreatic cancer. Pancreatic cancer~          carries a poor prognosis with an overall 5-year relative survival rate of 5.6%.~        -  Many doctors believe that individuals who have had surgery to remove pancreatic cancer~          should receive additional treatment, known as adjuvant therapy or adjuvant treatment, to~          prevent the cancer from returning. One chemotherapy drug that has been found to be~          effective in some patients with pancreatic cancer is called gemcitabine; it has been~          shown to improve patient survival by 6 months. Researchers are searching for new drugs~          or drug combinations to improve on these results.~        -  One of the leading causes for immune suppression in cancer patients was suggested to be~          associated with the elevated expression of programmed cell death ligand 1 (PD-L1) human~          B7 homolog 1 (B7-H1) at tumor-involved sites, either by the tumor itself or by~          surrounding cells like regulatory immune cells, resulting in the local suppression and~          apoptosis of tumor infiltrating effector lymphocytes.~        -  Some chemotherapy drugs kill cancer cells directly, but appear to prevent the immune~          system from helping in that fight. The experimental drug CT-011 is designed to help the~          immune system remain active to fight cancer cells. CT-011 has been tested in~          laboratories and studied for use with a number of other cancers, but it has not been~          given in combination with gemcitabine as a treatment for pancreatic cancer.~      Objective:~      - To test the safety and effectiveness of chemotherapy drugs gemcitabine and CT-011 as a~     follow-up treatment for pancreatic cancer that has been surgically removed.~      Eligibility:~      - Individuals at least 18 years of age who have had surgery to remove pancreatic cancer and~     have not had other types of follow-up treatments.~      Design:~        -  Participants will receive gemcitabine and CT-011 in 28-day cycles of treatment, and will~          be monitored throughout their treatment.~        -  Participants who do not have serious side effects and remain cancer-free may receive~          this drug combination every 28 days for a total of 6 cycles.~        -  Participants will have follow-up visits with additional blood tests every 2 months after~          stopping treatment for up to 2 years.~   "
172041|NCT01313403|"~     Background:~      - Medications to treat major depression act on a brain chemical called serotonin, which binds~     to receptors on brain cells. More research is needed on how serotonin receptors work in the~     brain, and imaging studies such as magnetic resonance imaging (MRI) can provide information~     on how these receptors function in the brains of individuals with depression and healthy~     volunteers. The experimental radioactive chemical [11C]CUMI has been designed to react with~     serotonin receptors, and researchers are interested in studying its effectiveness using~     positron emission tomography (PET) scanning to see how well it gets into the brain.~      Objectives:~      - To evaluate the effectiveness of the radiotracer [11C]CUMI in brain imaging studies of~     serotonin receptors.~      Eligibility:~      - Individuals between 18 and 55 years of age who either have been diagnosed with major~     depressive disorder or are healthy volunteers.~      Design:~        -  Participants will be screened with a full medical history, physical and psychiatric~          examination, blood and urine tests, and questionnaires about mood. Participants will~          also have an electrocardiogram at this visit.~        -  At the first study visit, participants will have a MRI scan of the brain to provide~          baseline data on brain function.~        -  At the second study visit, participants will have a PET scan with the [11C]CUMI contrast~          agent.~        -  No treatment will be provided as part of this protocol....~   "
172042|NCT01313390|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as docetaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. It is not yet known whether giving~     everolimus together with docetaxel is more effective than giving docetaxel alone in treating~     patients with head and neck cancer.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus given~     together with docetaxel in treating patients with recurrent, locally advanced, or metastatic~     head and neck cancer.~   "
172043|NCT01313377|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Observation is watching a patient's condition but not giving~     treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride~     together with oxaliplatin is more effective than observation in treating patients with~     biliary tract cancer that has been removed by surgery.~      PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride~     together with oxaliplatin to see how well it works compared with observation in treating~     patients with biliary tract cancer that has been removed by surgery.~   "
172044|NCT01313364|"~     This is a single-arm, single-center study in healthy volunteers. This study is designed to~     evaluate the safety of IM injections using single-use autoinjectors with a 25G × 1 needle.~     The purpose of this study is not to evaluate study treatment; therefore, all injections will~     be performed with Avonex placebo only; no active IFNβ-1a will be administered.~   "
172045|NCT01313338|"~     The purpose of this study is to examine the predictability of cognitive representation,~     emotional responses, and hospitalization experience toward the decision to receive treatment~     of the acute coronary syndrome patients.~   "
172046|NCT01313325|"~     The purpose of this study is to determine if adding hippotherapy treatment will improve~     balance for children ages 5-17 who have disabilities such as cerebral palsy and down~     syndrome. We also want to find out if by improving their balance the children increase their~     participation in age appropriate activities.~   "
172047|NCT01313312|"~     The purpose of this research study is to assess the long term safety of Dysport® in~     hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over~     repeated treatment cycles.~   "
172048|NCT01313299|"~     The purpose of this research study is to assess the efficacy of Dysport compared to placebo~     in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or~     traumatic brain injury.~   "
172051|NCT01313260|"~     Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated~     focus but surgical benefits are less clear for patients with a poorly defined focus such as~     non lesional refractory partial epilepsies.~      SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the~     procedure is risky with a limited spatial sampling. The development of non-invasive~     neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize~     SEEG procedures.~      The main hypothesis of this research project is the existence of a network organization~     specific for each patient which allows the generation and propagation of epileptic~     activities. The investigators wish to explore this network using diffusion tensor MRI to~     study structural connectivity and MEG/FMRI to study functional connectivity. The~     investigators will apply tools from the theories of complex networks and dynamical systems to~     characterize the network organization of epileptic process.~      The investigators aimed to identify and localize differences in connectivity parameters~     between individual patients and a control group of healthy volunteers.~   "
172052|NCT01313247|"~     Randomised, double-blind placebo controlled cross-over trial~      Main goal:~      Optimize the medical pain treatment for patients with advanced cancer disease~      Study goal:~      Measure paracetamol's additional analgesic effect in a situation where the patient is~     concomitantly treated with oral opioids eqv. morphine > 100 mg/d.~   "
172053|NCT01313234|"~     The purpose of this study is to investigate whether an intervention consisting of the~     implementation of guidelines about daily systematic pain assessment following a theory based~     education, targeting cancer-related pain and pain treatment, lead to a significantly positive~     improvement in RNs knowledge of, and attitudes towards their pain management. Furthermore~     will the interventions targeting the RNs influence the admitted patient's perception of their~     cancer-related pain?~   "
172054|NCT01313221|"~     To estimate the difference in effectiveness between treatment with etanercept 50 mg twice~     weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN)~     topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.~   "
172055|NCT01313208|"~     This study is designed to evaluate the effectiveness of adding etanercept to disease~     modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid~     Arthritis (RA).~   "
172056|NCT01313182|"~     We hypothesize the application of mupirocin or povidone-iodine to the nares is equally~     effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is~     to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary~     hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery~     requiring implantation of prosthetic material, when the patient receives either nasal~     mupirocin or nasal povidone-iodine prior to surgery.~      Secondary study objectives include:~        1. Measure hospital length of stay and re-admission rates in the mupirocin and~          povidone-iodine groups.~        2. Measure adverse events related to mupirocin and povidone-iodine.~        3. Measure rate of SA resistance to mupirocin.~   "
172057|NCT01313169|"~     The investigators conducted a controlled trial to assess the effectiveness of electronic~     medical record (EMR) reminders, with or without a panel manager, on completion of health care~     proxy, osteoporosis screening, and influenza and pneumococcal vaccinations for patients age~     65 or older. The investigators hypothesized that EMR reminders would improve adherence to~     practice guidelines and that benefits would be enhanced with the support of a panel manager.~   "
172058|NCT01313156|"~     Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns,~     perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic~     syndrome and type 2 diabetes~   "
172059|NCT01313143|"~     Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that~     of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their~     metabolites, by assessing the effect of both drugs on dobutamine-induced tachycardia, and by~     monitoring vital signs, ECG and adverse events.~   "
172060|NCT01313130|"~     Traumatic brain injury can cause permanent problems with thinking, memory, control of~     emotions, organization and planning. Thousands of soldiers, marines, and other military~     personnel have had injuries to the brain due the wars in Iraq and Afghanistan. Very large~     numbers of civilians, up to perhaps 1.5 million people per year, in the United States also~     have traumatic brain injuries caused by car accidents, falls, sports-related injuries or~     assault.~      We don't know very much about traumatic brain injuries right now, but there are some~     important new advances in technology that may help us learn a lot more about these injuries.~     One such advance involves new types of MRI scans that we think will be able to show what has~     happened to the brain after trauma more clearly that regular scans can. The first new scan is~     called diffusion tensor imaging, which shows injury to the axons (the wiring of the brain).~     The second new scan is called resting-state functional MRI correlation analysis, which shows~     how well various parts of the brain are connected to each other. Importantly, the new types~     of scans can be done using regular scanners that we already have in every major hospital. The~     innovation is entirely in how the scanners are used and how the resulting pictures are~     analyzed on a computer after they have been taken. We have already tested these scans on some~     military and civilian patients with brain injury and found them to be very helpful so far.~     Our overall goal is to see whether these new MRI scans will be useful for active duty~     military personnel who have had recent traumatic brain injuries. The most important goal will~     be to see if the amount of injury shown on the scans be used to predict how well the patients~     will do overall over the next 6-12 months. A related goal will be to see whether injuries to~     specific parts of the brain seen by these new scans can be used to predict whether patients~     will be likely to have specific problems like memory loss, attention deficit, depression, or~     post-traumatic stress disorder. We would also like to see whether the scans could be even~     more useful when combined with information about genetic factors (inherited from the parents)~     that can be tested in the blood. Another important goal is to compare the effects of~     traumatic brain injuries caused by blasts or explosions with injuries from other causes, to~     find out what is unique about blast injury. A final goal will be to repeat the scans 6-12~     months later to see whether the new MRI scans can show whether the injuries to the brain have~     healed, gotten worse, or stayed the same. These new scans could help with decisions about~     whether military personnel can return to duty, what sort of rehabilitation and treatment~     would benefit them most, and what family members should watch for and expect.~   "
172061|NCT01313117|"~     This study is being done because peripheral neuropathy, a condition that interrupts sensation~     in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha~     lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel.~     The purpose of this study is to assess the safety and tolerability of ALA and to find the~     best dose of ALA in patients that receive chemotherapy.~   "
172062|NCT01313104|"~     This clinical trial studies colposcopy and high resolution anoscopy in screening for anal~     dysplasia in patients with cervical, vaginal, or vulvar dysplasia or cancer. Screening may~     help doctors find cancer cells early and plan better treatment for cancer~   "
172309|NCT01309763|"~     This is a randomized, controlled, parallel group, patient-blinded, single-center, phase I~     pilot study to assess tolerability and safety of repeated subcutaneous administration of a~     single-dose of AFFITOPE AD03 applied with or without adjuvant to patients with mild to~     moderate Alzheimer's disease.~   "
172063|NCT01313078|"~     Background:~      - The best treatment for ovarian and related female reproductive tract cancers is not yet~     known for patients whose disease has not responded to or has recurred after standard~     treatment. The cancer treatment drug pegaspargase (ONCASPAR (Trademark)), which works~     differently from standard chemotherapy, has been approved to treat leukemia and has been~     given to a small number of patient with ovarian and other types of cancer. Because~     pegaspargase may reduce the development of cancer cells and blood vessel cells that~     contribute to cancer growth and ability to spread, treatment with pegaspargase could shrink~     ovarian cancer tumors and help ovarian cancer patients live longer and with fewer symptoms~     from their disease.~      Objectives:~      - To evaluate the safety and effectiveness of pegaspargase in patients with recurrent or~     refractory ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer.~      Eligibility:~      - Women at least 18 years of age who have been diagnosed with epithelial ovarian cancer,~     fallopian tube cancer, or primary peritoneal cancer that has not responded to at least one~     operation, chemotherapy, and/or radiotherapy.~      Design:~        -  Before the start of the study, participants will be screened with a medical history,~          blood tests, imaging scans of the affected areas, tumor biopsies, and other tests as~          directed by the study doctors.~        -  Participants will receive an infusion of pegaspargase on Day 1 and Day 15 of each 28-day~          cycle.~        -  Participants will have dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at~          the start of the study, before beginning pegaspargase, and again 6 weeks into the~          treatment. This test will determine if pegaspargase is affecting blood flow to the~          cancer site.~        -  Participants will have a computed tomography scan or other imaging every other cycle~          (approximately every 8 weeks) to determine whether the therapy is affecting the cancer~          site.~        -  The treatment will be repeated as long as the participant tolerates the medication and~          his or her cancer is either steady or improving.~   "
172064|NCT01313065|"~     The purpose of this study is to evaluate the safety and tolerability of IV administration of~     VX15/2503 in patients with advanced solid tumors. The escalation part of the study will~     determine the maximum tolerated dose (MTD).~   "
172065|NCT01313052|"~     The FACT model (ACT + legal leverage in the form of judicial monitoring) will be compared to~     enhanced outpatient treatment (close outpatient follow-up without judicial monitoring).~     Seventy adults with psychotic disorders in Monroe County who are convicted of a misdemeanor~     will be randomly assigned to each treatment group and followed for 12 months. Primary~     outcomes will include criminal justice and mental health service utilization rates, treatment~     adherence, psychiatric symptoms, substance abuse, homelessness, perceived coercion, and~     consumer satisfaction. Service utilization outcomes will be tracked using established mental~     health and criminal justice databases.~      Hypotheses are:~        1. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in~          promoting treatment adherence among high-risk adults with psychotic disorders.~        2. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in~          preventing arrest, incarceration, emergency department and inpatient hospital use among~          high-risk adults with psychotic disorders.~   "
172066|NCT01313039|"~     If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be~     possible to effectively use hormonal therapy in these patients resulting in improved~     outcomes. The investigators propose a single-arm Simon two-step study to examine whether~     treatment with AZD6244 will result in increased ER expression in ER-negative/low primary~     breast tumors.~   "
172067|NCT01313026|"~     A randomised trial testing the effect of percutaneous nerve evaluation and transanal~     irrigation on bowel function in patients after low anterior resection for rectal cancer.~   "
172068|NCT01313013|"~     question prompt sheet for outpatients suffering from depression. effects on~     patient-doctor-communication during the consultation.~   "
172069|NCT01313000|"~     The objective of this pilot study is to observe the utility of autologous transfer of fat~     collected using ultrasonic assisted liposuction into the upper arms with ultrasonic~     visualization.~   "
172070|NCT01312987|"~     The purpose of this research study is to assess what impact an integrated educational and~     feeding intervention delivered to infants and children has on growth (weight and height),~     development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and~     micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory~     and diarrheal) outcomes. A randomized community trial was used to implement a nutrition~     intervention program consisting of monthly education sessions, a lipid-based nutrition~     supplement, and food vouchers for local staples.~   "
172071|NCT01312961|"~     Primary Objective:~      To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC)~     once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma~     exacerbation in participants with persistent moderate to severe eosinophilic asthma.~      Secondary Objectives:~        -  To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in~          participants with persistent moderate to severe eosinophilic asthma.~        -  To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in~          participants with persistent moderate to severe eosinophilic asthma.~   "
172072|NCT01312948|"~     This study will evaluate a newly developed pediatric mask (known as Pixi) on children aged~     2-7 using continuous positive airway pressure (CPAP), or Non-invasive ventilation (NIV)~     treatment. The participants will undergo a monitored sleep study, followed by a 7 night trial~     of the Pixi mask in the home environment. During the study usability will be measured through~     questionnaires filled in by the parent and clinician.~      The study hypothesis is that the usability of the mask will be superior to the patient's~     usual mask.~   "
172073|NCT01312935|"~     The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in~     Patients Undergoing Percutaneous Coronary Intervention (PCI)~   "
172074|NCT01312922|"~     The overall objective of this trial is to demonstrate clinically relevant superior~     antidepressant efficacy of the fixed dose combination PNB01 (low dose pipamperone and~     citalopram) over reference antidepressant treatment with citalopram alone, and a low dose of~     psychoactive pipamperone alone in patients with moderate to severe Major Depressive Disorder.~      This study was specifically designed to assess patient related outcome (PRO) parameters using~     an Interactive Voice Response System (IVRS) via telephone.~   "
172075|NCT01312909|"~     The study is designed to see if varenicline combined with age appropriate (adolescent)~     smoking cessation counseling will help teens quit smoking.~   "
172076|NCT01312883|"~     Postpartum depressive symptoms are a major health problem that affects hundreds of women~     annually. The investgators propose to test an intervention to reduce postpartum depressive~     symptoms and prevent elevated levels of depressive symptoms in postpartum mothers by~     preparing and educating women about specific situational triggers of depressive symptoms, by~     bolstering personal and social resources, by enhancing self-management skills to buffer~     postpartum demands, and by increasing access to existing healthcare and community resources~     available to postpartum mothers.~   "
172077|NCT01312870|"~     The purpose of this study is to determine whether postoperative nutritional support improves~     postoperative outcomes in cardiac patients with malnutrition .~   "
172079|NCT01312844|"~     The primary purpose of this study is to assess the ability of scopolamine to improve the~     antidepressant effects of ECT and to determine whether scopolamine will shorten the time to~     response and remission for patients receiving ECT.~      The hypothesis are:~        1. Patients receiving ECT plus scopolamine will have greater improvement in depression~          symptoms than those receiving ECT plus placebo.~        2. Patients receiving scopolamine in addition to ECT will require fewer ECT treatments to~          obtain response/remission compared to the group receiving ECT plus placebo.~        3. Time to response and to remission in the scopolamine group will be significantly shorter~          compared to ECT alone.~   "
172080|NCT01312831|"~     The purpose of this study is to compare the efficacy and safety profile of a new oral vitamin~     B12 formulation (Eligen® B12) with intramuscular B12 in restoring normal B12 (cobalamin)~     concentrations in subjects with low cobalamin levels (<350 pg/mL).~   "
172081|NCT01312818|"~     Both of bortezomib and vorinostat have identified Phase II doses for pediatric and adult~     patients of which no grade 4 dose limiting toxicities have been observed in prior studies.~     The pre-clinical synergy of these 2 agents when used in combination along with the lack of~     over-riding toxicities and different mechanisms of action provide strong rationale for a~     clinical trial investigating bortezomib and vorinostat in combination. This trial will use~     the identified Phase II dose which is at or below the maximum tolerated dose for both agents~     which have very acceptable toxicity profiles and such should prove feasible and tolerable in~     this relapsed/refractory ALL population.~   "
172082|NCT01312805|"~     This study seeks to improve physician adherence to four recommendations of the NHLBI asthma~     treatment guidelines:~        1. Improve case detection of asthma among patients with pulmonary symptoms,~        2. Grade all asthma patients asthma, identifying those with persistent versus intermittent~          asthma,~        3. Improve rates of use of controller medications - particularly inhaled steroids - among~          patients with persistent asthma,~        4. Provide an asthma treatment plan for all asthma patients.~   "
172083|NCT01312792|"~     The investigators Study Hypothesis is introduction of modified IMCI guideline for managing~     severe pneumonia in first level health facilities will result in 40% increase in the~     appropriate management (appropriate case management at the first level facility and referral~     compliance by the caregivers) of severe pneumonia cases in the intervention arm compared to~     the comparison arm.~   "
172084|NCT01312779|"~     The purpose of this clinical study is to obtain human clinical data that demonstrates that~     the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is~     a safe and effective replacement heart valve.~   "
172085|NCT01312766|"~     The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety~     of two different subcutaneous hMG preparations when administered to patients undergoing~     controlled ovarian stimulation for IVF.~   "
172086|NCT01312740|"~     The investigators evaluated whether an energy-restricted protein diet with low glycaemic~     index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional~     diet (LC-CONV) on weight-loss and related metabolic variables.~   "
172087|NCT01312727|"~     The aim of this study is to identify families with hereditary chronic tubulointerstitial~     renal diseases , characterize the phenotype and screen for mutations in known genesis (UMOD,~     REN, TCF2, NPHP1). Genome wide analysis will be performed in families without mutations~     identified.~   "
172088|NCT01312714|"~     Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated~     with cardiovascular risk factors such as increased aortic pulse wave velocity, blood~     pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of~     26 weeks of vitamin D3 supplementation in patients with end stage renal disease.~   "
172089|NCT01312701|"~     Tumors have a systemic immune modifying effect. They affect the immune system similarly to~     states of chronic inflammation and these effects can:~        -  be monitored through analysis of nk t and myeloid cells mainly through studies of the~          zeta chain but also through other means~        -  may be decreased following effective anticancer therapy - may even be used to study the~          effectiveness of anticancer therapy~        -  are important to monitor if the investigators plan on formulation of systemic immune~          therapy Thus immumonitoring of systemic blood cells may turn out to be an important~          prognostic and predictive factor in many cancer types~   "
172090|NCT01312688|"~     The cardiovascular system plays a central role in the pathophysiology and prognosis of~     sepsis, yet the correct hemodynamic management of septic patients is still vigorously~     debated. Despite guidelines, the use of CVP and PAOP is seriously criticized for inaccurate~     prediction of fluid requirement. Recently studies showed that early goal-directed therapy~     (EGDT) aimed at achieving a ScvO2 of ≥70% significantly improved survival of septic shock~     patients, yet EGDT has not been adopted by all intensivists. The investigators have recently~     found using 2D echocardiography in 262 patients with severe sepsis or septic shock and~     treated by the conventional guidelines (without ScvO2) that diastolic dysfunction and reduced~     stroke volume index are strong independent predictors of mortality. In the present study the~     investigators intend to test the effect of EGDT on resuscitation, on long term myocardial~     function and left ventricular volumes and on survival in ICU patients with severe sepsis and~     septic shock. Patients will be randomized to EGDT (resuscitation directed by ScvO2) or~     standard of therapy for the first six hours after diagnosis of severe sepsis or septic shock~     and admission to the ICU. After six hours patients in septic shock will be further monitored~     with non invasive cardiac output (PiCCO, Pulsion Technologies). All patients will be followed~     daily by 2D & 3D transthoracic echocardiography with detailed measurements of systolic and~     diastolic left and right ventricular volumes and functions. Patients in the EGDT group will~     be compared to the control group for parameters of initial resuscitation (fluid volumes,~     ScvO2 achieved, inotrope use), initial values from non invasive cardiac output at six hours,~     interventions required from institution of non invasive cardiac output, early and long term~     effects on cardiac function and volumes from echo measurements, and mortality. The~     effectiveness of EGDT will thus be examined in the short and long terms.~   "
172091|NCT01312675|"~     The purpose of this study is to determine if Selective Adsorption System for Removal of~     Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.~   "
172092|NCT01312662|"~     Purpose of this study is to investigate the agreement, the test-retest reliability of three~     established and widely used visual acuity tests, to develop a mathematical transformation~     routine between the results from these three tests, to assess the examinees´ and examiners´~     acceptance and to compare the test durations.~   "
172120|NCT01312298|"~     Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia~     will result in shorter length of hospital stay for patients undergoing total knee~     arthroplasty.~      Primary endpoint: time from end of surgery until the patient is street ready~      Secondary endpoints: will general anesthesia produce less postoperative pain as compared to~     intrathecal anesthesia? Is there any difference in post operative dizziness between the~     groups.~   "
172093|NCT01312649|"~     The investigators aim is to understand the cognitive mechanisms that contribute to the~     emergence of delusions of control (the belief that one's own actions or thoughts are~     controlled by an external force). These symptoms are mainly encountered in patients with~     schizophrenia, and the investigators will distinguish patients with schizophrenia with or~     without this symptom together with patients with bipolar disorder. Based on the investigators~     previous studies, this project will help to determine the role of two elementary mechanisms~     in the ability to feel in control of voluntary actions: (1) the processing of the sensory~     consequences of action, and (2) the ability to build mental representations for sequenced~     actions.~   "
172094|NCT01312636|"~     This study is conducted in Japan. The aim of this observational study is to evaluate the~     long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in~     subjects with congenital FVII deficiency.~   "
172095|NCT01312623|"~     Cardiac surgery is associated with risk of perioperative inflammation and ischemia leading to~     cerebral and myocardial morbidity and mortality. Ischemic preconditioning by repetitive~     ischemic episodes at an organ can reduce damage resulting from consecutive prolonged ischemia~     in that organ. Remote ischemic preconditioning is defined as ischemic preconditioning by~     repetitive ischemic episodes of an organ remote from the organ to be protected, e.g. ischemic~     episodes of a limb can reduce ischemic damage of the heart. Animal studies as well as human~     studies have shown that ischemic preconditioning can protect the heart from intraoperative~     ischemia. Remote preconditioning by repetitive limb ischemia has been applied in humans in~     some studies.12-14 However, the published data is not yet sufficient to support evidence~     based recommendations for clinical practice. In particular, available data regarding the~     influence of remote preconditioning on inflammatory and ischemic damage of brain and heart in~     children following surgery of congenital heart disease are limited. Hence, this prospective,~     controlled and randomized study was designed to perform remote ischemic preconditioning in~     children after induction of anesthesia for pediatric heart surgery and to investigate the~     effect on postoperative organ function in comparison to a control group.~   "
172096|NCT01312610|"~     This study is investigating the effect of 8 weeks of orange juice supplementation on~     executive function in healthy older adults. The study is a controled, double-blind, crossover~     trial and involves a 8 week supplementation with a high flavonone orange juice and a~     carbohydrate-matched control. Volunteers consume 500ml of either the test juice or the~     control juice per day for an 8 week period. There is then an 8 week washout period before~     subjects proceed to the other arm of the study. Subjects are randomly assigned to either arm~     at the beginning of the study. Measures of cognitive function will be administered pre and~     post both test and control interventions. Blood pressure will also be measured and blood and~     urine samples will be collected to assess absorption of from the juice. A sub-sample of~     volunteers will undergo MRI imaging pre- and post intervention to acquire cerebral blow flow~     information.~   "
172097|NCT01312597|"~     The purpose of this study is to investigate changes in cerebral blood flow, blood flavonoid~     levels, brain-derived neurotrophic factor, vascular reactivity and cognitive performance in~     young adults as a result of acute administration of a fruit-derived flavonoid-rich or~     flavonoid-poor drink.~   "
172098|NCT01312584|"~     The primary propose of this study is to determine how processing, in particular alkalisation,~     alters the vascular effects of high-flavanols foods such as cocoa~   "
172099|NCT01312571|"~     Forty-eight people diagnosed with social phobia in an experimental study that randomized into~     two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2)~     computerized attention training (n = 24). After nine weeks we change the condition of the two~     groups of research participants, which should therefore be given both treatments. Pre-and~     post measurement of functional magnetic resonance imaging (fMRI) will take place in the first~     round of treatment. Genotyping based on saliva samples takes place before the start of~     treatment, at the first fMRI measurement, for those who voluntarily leave the sample.~      Study hypothesis~      How is the brain activity of emotional processing and anxiety affected after completing an~     Internet-based CBT compared with computerized attention training? Does the treatment response~     of an Internet based treatment affects by variations in serotonin-transporter-linked promoter~     region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3) genes?~      How is the genetic variations related to symptoms in social phobia (pre treatment)?~   "
172100|NCT01312558|"~     This study aims to investigate the role of the Mediterranean diet in obese patients with~     Obstructive sleep apnoea-hypopnoea syndrome.~   "
172101|NCT01312545|"~     This study wants to compare between two types of implants in enucleation. Both of them are~     made from porous polyethylene but have different fabricating techniques. The investigators~     chose an exposure rate as a main outcome because the investigators think it is the most~     important outcome for the surgeons. The study hypothesis is: Is the exposure rate of a~     local-made polyethylene orbital implant the same as an imported one?~   "
172102|NCT01312532|"~     The purpose of this study is to determine which prosthesis is better in total knee~     arthroplasty~   "
172103|NCT01312519|"~     This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration~     system (OnControl by Vidacare) compared to traditional manual devices. The hypothesis is that~     the powered system will reduce the level of patient pain during the aspiration and core~     biopsy procedures and the amount of time needed to perform the procedures.~   "
172104|NCT01312506|"~     This study has two ultimate goals:~        1. Understand how the original melanoma from the skin spreads to the CNS. In order to study~          this we need to collect (and compare) the original skin melanoma, the CNS melanoma, as~          well as any other melanoma that has not metastasized to the CNS.~        2. Develop a diagnostic blood test that will early identify subjects at high risk for~          developing CNS metastasis or patients who may already have CNS metastasis but the MRI or~          the CAT scan cannot yet detect it. Thus, the investigators plan to collect CSF from~          subjects like you who have melanoma CNS metastases in order to confirm the presence of~          this biomarker.~   "
172105|NCT01312493|"~     This is a non-randomized phase II study of targeted radiotherapy (RT) administered~     concurrently with panitumumab in patients with locally advanced squamous carcinoma of the~     head and neck.~   "
172121|NCT01312285|"~     The purpose of this study is to see if using a device called the Resonator, that puts out~     very low level electromagnetic fields will help symptoms of painful hip(s)~   "
172106|NCT01312480|"~     This is a study of the effectiveness of adolescent smoking cessation interventions in~     pediatric primary care settings. Our specific aims are to:~        1. Demonstrate providers' fidelity to guidelines for tobacco counseling and delivery of~          cessation interventions using practice system changes over time, (including systematic~          screening using charting tools and linkages to adjunct materials, including self-help~          handouts and Internet resources); and~        2. Assess the impact of primary care provider counseling interventions on adolescent~          smoking cessation.~      We hypothesize that adolescents who receive guidelines-based clinician-delivered smoking~     cessation counseling at primary care visits will be more likely to make quit attempts and~     more likely to remain abstinent (with better long term cessation rates) at 6 and 12 months~     after intervention, compared to those who do not receive interventions. In addition, we~     hypothesize that successful referral to stage-based self-help adjuncts, and more adjunct use~     will be associated with more quit attempts and better long-term cessation rates.~      We will evaluate provider interventions in up to 120 pediatric practices, recruited from the~     American Academy of Pediatric's Pediatric Research in Office Settings (PROS) practice-based~     research network. Adolescents presenting for care will complete a short baseline survey prior~     to their doctor-visit, and a percentage of participants will be surveyed by phone 4‐6 weeks~     after their visits to assess quit attempts and short-term cessation, and again at 6 and 12~     months to evaluate long-term cessation outcomes. We will describe the patterns of smoking~     among youth, and explore how much receiving interventions affects motivation, quitting,~     abstinence/relapse attitudes, attitudes and use of adjunct strategies, and other smoking~     behaviors for adolescent smokers.~   "
172107|NCT01312467|"~     The purpose of this study is to find out whether METFORMIN decreases protein markers in~     colorectal tissue. This is a phase IIA study of the pharmacodynamics, safety and tolerability~     of Metformin in decreasing colorectal mucosa in patients with a history of colorectal~     adenomas in the past 3 years and a BMI >= 30, with decimals rounded to the nearest whole~     integer. Metformin as a potential chemopreventive agent for inhibition of the relevant~     molecular pathways involved in human colorectal carcinogenesis.~   "
172108|NCT01312454|"~     The purpose of this study was to assess the safety and efficacy of AL-59412C injected~     intravitreally relative to Vehicle.~   "
172109|NCT01312441|"~     The prevalence of vitamin D deficiency increases as kidney function declines. As a result,~     many hemodialysis patients often have low levels of vitamin D. Recent evidence has shown that~     vitamin D supplementation may improve many aspects of poor health such as heart disease and~     inflammatory markers. The objectives of this study are to determine how supplementing~     dialysis patients with ergocalciferol increases vitamin D levels, how long vitamin D levels~     can be maintained after a 6 month treatment course, and to examine the effect of~     ergocalciferol on biomarkers of inflammation and vascular health.~   "
172110|NCT01312428|"~     The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL)~     instrument in achieving desired acetabular position, desired leg length and offset after~     Total Hip Replacement (THR) reconstruction.~   "
172111|NCT01312415|"~     Total knee replacement (TKR) is associated postoperatively with considerable pain and~     analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia~     with intrathecal bupivacaine plus preservative free morphine. We hypothesize that~     infiltration of the surgical site with peri- and intraarticular levobupivacaine local~     anaesthetic would be an efficacious pain management technique and would not be inferior to~     intrathecal morphine for postoperative pain management.~      We further hypothesize that the use of this surgical site infiltration technique would~     decrease post-operative systemic opioid requirements as well as the side effects associated~     with intrathecal and systemic opioids.~   "
172112|NCT01312402|"~     This study is a prospective, single crossover, double-masked, controlled clinical trial that~     will use topical brinzolamide (Azopt)ophthalmic medication to try to improve the nystagmus~     and visual consequences of nystagmus in patients with infantile nystagmus syndrome (INS).~     Subjects will undergo a clinical exam, questionnaire and eye movement recordings on day 1 and~     then receive either topical Azopt or placebo three times a day in both eyes for days 2,3 and~     4 followed on the morning of day 5 by a repeat clinical exam, questionnaire and eye movement~     recordings. After at least one week, this protocol is repeated with the crossover regimen~     being taken by the subject. One week after all medications are discontinued, another clinical~     exam is done before study discharge. The hypothesis is that nystagmus and associated visual~     symptoms will be improved while on the Azopt compared to the placebo. There will be a total~     of 5 visits over a 1-2 month period.~   "
172113|NCT01312389|"~     This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or~     primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity~     of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L)~     administered by intradermal/subcutaneous injection in combination with Ampligen~     (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months.~   "
172114|NCT01312376|"~     This is a phase-I clinical trial to determine the feasibility and safety of~     Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of~     Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex~     vivo CD3/CD28-costimulated peripheral blood autologous T cells and vaccination with whole~     tumor vaccine administered intradermally in combination with Bevacizumab in patients with~     recurrent ovarian cancer fallopian tube or primary peritoneal cancer. (Funding Source - FDA~     OOPD)~   "
172115|NCT01312363|"~     The investigators plan to see what factors can influence the durability of Exelon patch~     treatment in Korean patients with Alzheimer's disease.~      Based on these results, the investigators will find the ways to maximize the effect and~     durability of Exelon patch on Korean patients with Alzheimer's disease.~      After finishing this study, the investigators are going to present the study results at the~     international and national academic meetings or conferences.~      Also the investigators expect that they can publish the result in a journal of in the field~     of neurology or dementia till the winter of 2010.~   "
172116|NCT01312350|"~     The investigators will examine whether 2-cycles of DFP chemotherapy before definitive~     concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally~     advanced (Stage III & IVM0) hypopharyngeal and base of tongue carcinoma compared to~     definitive CCRT alone.~   "
172117|NCT01312337|"~     The investigators will examine efficacy and toxicity of gefitinib in Korean patients with~     EGFR wild tumors diagnosed with direct sequence test.~   "
172118|NCT01312324|"~     We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete~     resection rate in advanced thymic carcinoma.~   "
172119|NCT01312311|"~     The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the~     first-line therapy for recurrent of metastatic nasophayngeal cancer~   "
172335|NCT01309412|"~     The purpose of this study is to assess the safety and the tolerability of siltuximab up to~     11.0 mg/kg in combination with bortezomib and dexamethasone for patients with relapsed or~     refractory multiple myeloma.~   "
172122|NCT01312272|"~     Individuals with schizophrenia have been found to have deficits in social cognition, which is~     defined as the functions that are engaged during social interactions. Social cognition has~     been found to be critical in predicting multiple aspects of community functioning. There are~     no currently available medications that have been consistently found to improve social~     cognition in individuals with schizophrenia. Oxytocin functions as a neurotransmitter that is~     thought to be involved in multiple aspects of social behavior and related emotions. In this~     study, we test the hypothesis that acute administration of intranasal oxytocin will improve~     social cognition in individuals with schizophrenia.~   "
172123|NCT01312259|"~     Purpose:~        1. To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral~          neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome~          (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a~          frequency of 14 hertz (standard).~        2. The evaluate the efficacy of the two frequency settings on the other associated~          conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction~          (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of~          the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).~   "
172124|NCT01312246|"~     In this study the investigators will include adult patients who are not part of a vulnerable~     patient population. Inclusion criteria include patients who will be undergoing resection of~     part of their colon that will require dividing the IMA. The investigators will use the~     resected surgical specimens for our project. The investigators will use the EnSeal on all~     major vessels in our procedure. The investigators will use the EnSeal 5 mm round head model.~     Due to the nature of the project, we will apply for IRB approval prior to beginning our~     research. The investigators plan to include 60 total patients in the study, 30 at the~     University of Illinois and 30 at Lutheran General Hospital.~      Prior to resection, the investigators will use a sterile caliper to take an in-vivo~     measurement of the IMA and IMV. Immediately after resection, the investigators will remove~     the sealed proximal end of the IMA and the 3 cm distal to it from the surgical specimen. The~     investigators will similarly prepare the IMV. The investigators will inspect our vessels for~     any iatrogenic traumatic tears. If the vessels are suitable, the investigators will then~     gentle apply manual traction to remove any blood or clots within the lumen. The investigators~     will measure the outer diameter of the vessels using a digital caliper. If there are small~     branches, the investigators will tie them off with suture. The unsealed end will then be~     attached to the burst pressure tester with suture and it will be tested for the bursting~     pressure. The device measures pressure continuously as it infuses the segment with normal~     saline at a steady rate (50 ml/hr). A leak will be determined by a decrease in intra-luminal~     pressure of 100 mm Hg or a visible leak. A failure to seal the vessels will be determined by~     a bursting pressure of less than 100 mm Hg. It should be noted that each section would only~     be pressure-tested once. All of our data will be collected on the enclosed data sheet we have~     created for use in this protocol. The investigators will then place the vessels with the~     original surgical specimen where it will be submitted for routine pathological examination of~     surgical specimens. Twenty five specimens at each site will undergo the testing, whereas 5~     specimens will be sent to pathology without testing.~      Our pathologist will analyze the submitted specimen for extent of seal, disruption of vessel~     smooth muscle, gas bubbles, and will stain for elastin to analyze the disruption in the~     vessel wall. In addition, the seal will be measured and we will obtain digital images. The~     specimens submitted for pathology will be 5 burst specimens as well as 5 un-burst specimens~     taken from the pool of 25 patients at UIC.~      For our human component, the investigators have estimated the standard deviation and width of~     the confidence interval to be 100 mm Hg each. With a 95% confidence level, the investigators~     expect to require 16 measurements for human specimens from 16 patients although the~     investigators will use 50 patients to allow for errors in obtaining pressures.~      Our timeline for the completion of the projects is 6 months. The investigators plan on being~     able to complete the human burst pressure testing within 6 months.~   "
172125|NCT01312233|"~     The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial~     is to evaluate the clinical effectiveness and feasibility of a collaborative care model~     (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with~     120 older adults over the age of 65 with low back pain of at least 1 month duration.~   "
172126|NCT01312220|"~     To study the correlation of serological growth factors and the hepatic progenitor cells~     involved in liver regeneration of liver failure.~   "
172127|NCT01312207|"~     Objective: To evaluate the clinical manifestations and surgical prognosis of macular~     tractional retinoschisis in proliferative diabetic retinopathy.~      Design: Retrospective case series. Participants: Cases with macular tractional retinoschisis~     with or without combined traction detachment (TRD) in proliferative diabetic retinopathy~     confirmed by optical coherence tomography (OCT) at a single institution between January 2007~     and August 2010.~      Methods: Cases were divided into two groups. Group A had tractional retinoschisis only while~     Group B had TRD with retinoschisis of the elevated retina. Clinical data including OCT~     findings were recorded and analyzed.~      Main Outcome Measures: Demographic data, clinical pictures, surgical results, and OCT~     findings will be compared between two the groups.~   "
172128|NCT01312194|"~     The main objective of this study is the prevention and repair of apical periodontitis in~     lower molars with pulp necrosis after the execution of endodontic treatment in one or two~     visits in adolescent patients. Moreover, it is also observed the frequency of postoperative~     pain in endodontic treatment.~   "
172129|NCT01312181|"~     Among HIV-infected individuals, non-injection drug use (NIDU) is associated with poor HIV~     medication adherence, greater HIV/AIDS risk behaviors, and increasing non-AIDS mortality.~     Thus reducing NIDU among HIV infected individuals is critical to their survival and to~     limiting the spread of HIV. We propose to study the efficacy of a technologically enhanced~     brief intervention (HealthCall) to reduce NIDU in HIV primary care patients that demands~     little from busy medical staff and is well accepted by patients. In a 3-arm randomized~     clinical trial will test the efficacy of (a) Motivational Interviewing (MI)+HealthCall; (b)~     MI-only; and (c) a control condition (advice + DVD HIV health education) in reducing NIDU.~   "
172130|NCT01312168|"~     This purpose of this study is to~        1. Determine the change in endothelial dependent vascular reactivity and vascular~          properties~        2. Determine the changes in monocytes activation~        3. Determine the change in pro-inflammatory status~        4. Investigate the effect of six-month CPAP therapy on the above changes in patients with~          OSA~   "
172131|NCT01312155|"~     The study investigates assisted intubation using a videolaryngoscope in anesthesia.~   "
172159|NCT01311778|"~     Despite the current available therapies for opioid-dependent patients, most patients relapse.~     This research project focuses on the development of a novel compound, cannabidiol, to~     modulate opioid craving in humans based on animal models showing its selective effectiveness~     to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse~     would be of tremendous medical and public health value.~   "
172160|NCT01311765|"~     The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for~     postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days~     period when compared to conventional (15 days) treatment.~   "
172209|NCT01311102|"~     The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will~     reduce pain scores related to that procedure. In a double blinded randomized trial of 60~     women receiving either normal saline or lidocaine infused through an endometrial aspirator,~     pain scores will be obtained for each step of the IUD placement procedure and for the total~     experience.~   "
172132|NCT01312142|"~     Weaning from mechanical ventilator is an essential element in the care of critically ill~     intubated patients receiving mechanical ventilation. It covers the entire process of~     liberating the patient from mechanical support and from endotracheal tube.~      The process of weaning involves two-step strategies: 1. Assessment of readiness for weaning,~     including physiological measurement, such as maximum inspiratory pressure, tidal volume,~     respiratory rate and etc. 2. Spontaneous breathing trial.~      Tracheostomy has become an increasingly common intervention in ICUs, especially for patients~     with prolonged mechanical ventilator support.~      Tracheostomy may reduce work of breathing by improving some aspects of pulmonary mechanics,~     such as reducing dead space and decreasing airway resistance, but to date, there is no~     evidence that this is linked to reduction in weaning time or length of stay.~      The investigators believe such improvement in pulmonary mechanic, which may reflect in the~     weaning parameter that respiratory therapist measured before weaning program, may be~     different from that measured before tracheostomy creation.~      The investigators therefore hypothesized that the improvement in pulmonary mechanic for~     patients with weaning failure after tracheostomy may reflect on weaning parameters, and that~     this improvement may be able to predict the subsequent successful weaning from mechanical~     ventilator support.~      Hereby the investigators perform a prospective single-center study to investigate the changes~     of weaning parameters in difficult weaning patients after tracheostomy as a predictor of~     subsequent successful weaning.~   "
172133|NCT01312129|"~     The overarching objective of this pilot study is to apply both neuroimaging and~     pharmacogenetic tools to the study of alcohol dependence. This proposed research will provide~     a mechanistic test of the function of the genetic variation. The specific aims and hypotheses~     are to test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level~     dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). To~     test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment on BOLD~     difference maps for the contrast alcohol minus control. We will also explore whether specific~     genetic variations influence this effect. A double-blind, placebo-controlled 2 (Medication:~     Sulfasalazine 1500 mg vs. placebo control) x 2 (Cue: Alcohol Cue vs. Control cue)~     within-subjects, crossover design will be used to test the hypothesis that Sulfasalazine~     reduces the BOLD response in the striatum and prefrontal cortex after exposure to alcohol~     cues. Twenty alcohol-dependent participants will complete two rounds of the study medication~     followed by an functional magnetic resonance imaging (fMRI) scan, during which they will~     complete an alcohol cue-exposure task. The order of the medication condition will be~     counterbalanced such that subjects will be randomly assigned to receive either Sulfasalazine~     (1500 mg) in the first session and placebo in the second session one week later (or vice~     versa). This pilot study will help to determine whether NMDA receptors play a role in~     cue-elicited activation of key areas of the brain implicated in the development and~     maintenance of substance use disorders. Furthermore, if Sulfasalazine reduces cue-elicited~     activation of these brain regions, as hypothesized; this study will lay the groundwork for a~     larger trial on the efficacy of Sulfasalazine as a treatment for substance use disorders.~   "
172134|NCT01312116|"~     The objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or~     Internet-delivered psychodynamic therapy (iPDT) performs better for a population with~     generalized anxiety disorder (GAD), compared to a wait-list control condition.~   "
172135|NCT01312103|"~     The purpose for this trial is to test the effectiveness of the first interactive~     internet-based safety decision aid on abused women's exposure to repeat intimate partner~     violence (IPV) and mental health outcomes. An improved safety decision-making process (e.g.,~     knowing the advantages and disadvantages of the relationship, having enough information to~     make a decision) will increase safety-seeking behaviors which in turn will decrease exposure~     to repeat IPV and improve mental health outcomes. Findings from the development and initial~     test of our computerized safety decision aid suggests that it offered abused women privacy to~     consider personalized safety options, informed them about danger in their relationship and~     would be used again if they had access to it through a safe internet site.~      The investigators are conducting a five year experimental trial in four states (Oregon,~     Maryland, Missouri, and Arizona) to address the following aims:~        1. Test the effectiveness of an interactive internet-based safety decision aid on abused~          women's safety seeking behaviors and exposure to violence compared to women assigned to~          control websites. The investigators hypothesize that at three, six, and 12 months~          post-baseline the intervention group will have increased safety seeking behaviors and~          reduced IPV exposure in comparison to the control group.~        2. Test the effectiveness of an interactive internet-based safety decision aid on abused~          women's mental health compared to women assigned to control websites. The investigators~          hypothesize that at three, six, and 12 months post-baseline the intervention group will~          have improved mental health in comparison to the control group.~        3. Test if the effect of an interactive internet-based safety decision aid on abused~          women's mental health and exposure to violence is mediated by the safety decision making~          process and safety-seeking behaviors. The investigators hypothesize that the~          intervention group will have a better decision making process and have greater safety~          seeking behavior over the year in comparison to the control group, and that this better~          decision process and increased safety seeking behavior will mediate improvement in~          mental health and exposure to violence at 12 months post baseline.~      This study will provide much needed new information about safety planning's impact on making~     difficult safety decisions, exposure to violence, and mental health effects.~   "
172136|NCT01312090|"~     1. To test whether chronic intermittent cold exposure is more effective in programmed body~          weight loss when compared to conventional programmed weight loss.~        2. To measure the metabolic responses (e.g. in the white and brown adipose tissue, muscle~          and circulating markers) of treatment with chronic intermittent cold exposure and~          conventional treatment~        3. To measure tissue specific changes of weight loss and the treatment with chronic~          intermittent cold exposure in glucose uptake rate in adipose organ (white and brown~          adipose tissue), liver, myocardium, skeletal muscle and brain~        4. To measure tissue specific biochemical indicators before and after treatment with~          chronic intermittent cold exposure from white adipose tissue and skeletal muscle.~        5. To compare changes in body composition and fat distribution after weight loss using~          chronic cold exposure or using conventional method~   "
172137|NCT01312077|"~     Total hip replacement is a major surgical procedure usually associated with significant pain~     in the early postoperative period. In our hospital, total hip replacement is routinely~     performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus opioid~     in the form of preservative free morphine. The use of 'local infiltration analgesia' as an~     alternative postoperative analgesic technique has been investigated.In this technique the~     surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a~     catheter under direct vision which remains in situ and is used to administer local~     anaesthetic in the postoperative period until such time as it is removed (when no longer~     deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48~     hours). We hypothesize that infiltration of the surgical site with peri- and intraarticular~     levobupivacaine local anaesthetic would be an efficacious pain management technique and would~     not be inferior to intrathecal morphine for postoperative pain management.~   "
172138|NCT01312064|"~     The investigators hypothesized that everolimus-based immunosuppressive therapy combined with~     rituximab induction could provide comparable safety profiles for renal transplant patients,~     as compared to standard immunosuppressive therapy using thymoglobulin induction, tacrolimus,~     mycophenolate mofetil and steroids, in terms of acute rejection rate and renal function.~      Rituximab was reported to reverse refractory acute kidney transplant rejection. Combined with~     immunoadsorption with or without IVIG, rituximab could successfully prevent antibody-mediated~     rejection in ABO-incompatible renal transplantation. This study is to assess whether a~     CNI-free regimen including B-cell depleting antibody induction, everolimus and MMF results in~     comparable long-term function without a negative impact on safety or efficacy of~     immunosuppression. This study will be open-label and two-arm randomized (2:1).~   "
172139|NCT01312051|"~     Blacks are at increased risk for obesity, type 2 diabetes mellitus and cardiovascular~     disease. A common pathogenetic link among these entities is insulin~     resistance/hyperinsulinemia.~      The specific aims of this project are: 1) to compare skeletal muscle lipid content (SMLC) in~     black vs white children by computed tomography (CT) scan of the mid-thigh, and assess the~     relationship to in vivo insulin sensitivity; 2) to test the hypothesis that free fatty acid~     (FFA) - induced insulin resistance is associated with larger increases in intramyocellular~     lipid (IMCL) in black vs white adolescents; 3) to examine if β-cell insulin secretion in~     prepubertal black children is more sensitive to the stimulatory effect of FFA than in whites;~     and 4) to test if the β-cell in black obese adolescents is more susceptible to the lipotoxic~     effect of FFA compared with whites. The methods to be used are: the well- established CT~     method as well as Magnetic Resonance Spectroscopy (1H-MRS) to assess SMLC and IMCL;~     intralipid infusion to elevate circulating FFA levels; the hyperinsulinemic-euglycemic clamp~     with stable isotopes and indirect calorimetry to measure insulin sensitivity and substrate~     turnover; the hyperglycemic clamp to assess insulin secretion; DEXA and whole body MRI for~     body composition assessments.~   "
172140|NCT01312038|"~     This study is designed to measure the effects of a chewable Simethicone tablet taken by mouth~     on middle-ear pressure in adults with a common cold and evidence of abnormal middle-ear~     pressure. In children and adults, middle-ear diseases such as otitis media (the buildup of~     fluid within the middle ear) and a form of temporary hearing loss occur if the Eustachian~     tube does not open, does not open often enough or is always open. Simethicone, available~     over-the-counter under several brand names including Gas-X, may help break up the bubbles~     that may block the opening of the Eustachian tube in the back of the nose during a cold,~     allowing air to pass between the nose and middle ear. This study requires a single visit to~     the Middle Ear Physiology Laboratory in the Oakland section of Pittsburgh. If eligible for~     the study, Eustachian tube function testing will be done; the Simethicone tablet or placebo~     (a tablet that looks and tastes like the Simethicone tablet but has no active ingredient)~     will be given and Eustachian tube function testing repeated.~   "
172141|NCT01312025|"~     In conventional laparoscopic cholecystectomy, the cystic duct and artery are clipped by metal~     clips. we propose a new method in which the cystic duct is ligated and the cystic artery is~     cauterized. the investigators compare both methods.~   "
172142|NCT01312012|"~     Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in our~     general population reduced from 15-20%, down to < 1% in the post-vaccination population.~     However, children born to HBeAg positive mothers still may be infected with HBV despite~     immunization. To further reducing the HBV infection in our people, strategies in reducing~     infection rate in this high risk group are mandatory. Previous small scale studies using~     lamivudine treatment in pregnant woman in the third trimester has proved effective in~     reducing children infection rate. The aims of the present study are to conduct a clinical~     trial in using Tenofovir (category B) to reduce mother-to-infant transmission, and to monitor~     the hepaitits B viral status and mother hepatitis occurrence. The clinical trials will screen~     cases of HBsAg positive pregnant women aged 20 to 40 years at gestational at 20-32 weeks.~     They will be tested for HBsAg and HBeAg. In whom both markers are positive, HBV viral load~     will be tested. An estimated 180 pregnant women with high HBV viral load (>10^8 copies/mL)~     will be recruited in the study; including 80-100 subjects treated with Tenofovir 300 mg daily~     starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month after~     delivery; and 80-100 pregnant women are enrolled as controls with no drug given to the~     mother. The newborn babies are given with HBIG within 24 hours after delivery, and HBV~     vaccines at 0, 1 and 6 months. Maternal complete blood count (CBC) data tested in the first~     prenatal examination will be recorded. Plasma AST、ALT levels and HBV DNA are tested before~     Tenofovir treatment, 1 month after treatment, at the time of delivery, and at 1, 2, 4 and 6~     months after delivery. HBsAg、HBeAg、anti-HBs and AST、ALT are tested in the children at day 1,~     6 moths and 1 year after birth. The primary outcome is reduction of the HBsAg carrier rate of~     the children at 6 months of age. The secondary outcome is HBsAg carrier rate of the children~     at 12 months of age, the change of liver function, HBeAg, and viral load in pregnant mother~     after treatment.~      A follow-up study for investigating safety of mothers and children that has been exposed to~     maternal tenofovir disoproxil fumarate (TDF) during pregnancy in reducing mother-to-infant~     hepatitis B virus (HBV) transmissions is conducted. The follow-up study included~     mother-children pairs 2-4 years after delivery of the children.~   "
172143|NCT01311999|"~     To follow-up the latent tuberculosis infection and the risk of developing active tuberculosis~     in patients receiving long-term dialysis~   "
172144|NCT01311986|"~     The aim of this study is to measure the serum levels of CCL17, CCL18, CCL22 and CXCL10 and~     their expression levels in epidermis in AD and ND patients.~   "
172145|NCT01311973|"~     The specific purpose of this study is to describe the relationship between salivary~     phosphorus and kidney function, specifically as it relates to serum phosphorus, FGF23, PTH,~     vitamin D status and urinary excretion of phosphorus.~   "
172146|NCT01311960|"~     The purpose of this study is to determine whether bevacizumab eye drop is effective in the~     treatment of recurrent pterygium.~   "
172147|NCT01311947|"~     In order to clarify the association between HBV mutations appearing before and during~     interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive~     CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the~     mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations.~     Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and~     deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally,~     statistical analysis will be done to elucidate whether the mutations of preS/S gene and~     BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.~   "
172148|NCT01311934|"~     The acoustic radiation force impulse (ARFI) technology provides real-time measurements of~     tissue stiffness.~      Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation~     and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis~     scoring and to conduct subsequent innovative studies on liver diseases.~   "
172175|NCT01311557|"~     The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced~     Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10~     years of age.~      Primary Objectives:~        -  To compare pertussis antibody responses induced by Adacel® in persons 10 to <11 years of~          age to those induced by Adacel in persons 11 to <12 years of age.~        -  To compare the booster responses against pertussis antigens induced by Adacel in persons~          10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.~        -  To compare booster responses against tetanus and diphtheria induced by Adacel in persons~          10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.~      Secondary Objective:~        -  To compare seroprotection rates against tetanus and diphtheria induced by Adacel in~          persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of~          age.~   "
172149|NCT01311921|"~     EV71 has caused large epidemics with lots of fatal cases and cases with sequelae. However,~     the clinical syndromes and severity of the same EV71 strain are very diverse, ranging from~     asymptomatic (71%) to fatal (0.05%) disease, and the pathogenesis remains unknown. In~     addition, the severe or fatal case incidence varies significantly differently in different~     areas of Taiwan. Although some viral virulence studies were performed, no clear viral~     virulence factor has been found. Therefore, host factors may be important to the clinical~     outcomes of EV71 infections. In addition, there were significantly different incidences of~     severe or fatal cases in different areas of Taiwan, for example, significantly more fatal or~     severe cases occurred in the central or southern Taiwan in comparison with in northern~     Taiwan. Whether this is related to host factors, social, behavioral or environmental factors~     remains unanswered. To find the most important factors associated with EV71 susceptibility, a~     thorough study involving genetics, social, behavioral or environmental factors among~     different areas of Taiwan is warranted and the findings will provide future prevention of~     EV71 and give help on early precaution and treatment of EV71.~   "
172150|NCT01311908|"~     Reflux esophagitis is a common complication following distal gastrectomy. According to the~     investigators preliminary data, an Roux-en--Y gastrointestinal reconstruction in~     pancreaticoduodenectomy is associated with higher rates of reflux esophagitis. In this study,~     the investigators will investigate the incidence of reflux esophagitis after above procedure~     by the 24-h pH monitoring of esophagogastric junction.~   "
172151|NCT01311895|"~     The purpose of this study is to compare two opioid protocols (H2O and 1+1) for the~     treatment of acute severe pain in the emergency department. The investigators primary~     hypothesis is that the H2O protocol will be more efficacious than the 1+1 protocol in~     Emergency Department patients aged 21-64 years. The primary outcome is the proportion of~     patients in each arm who choose to forgo additional pain medication at 60 minutes.~   "
172152|NCT01311882|"~     This is a study to evaluate next-day residual effects of MK-4305 on highway driving~     performance in healthy, non-elderly participants.~   "
172153|NCT01311869|"~     Uterine Leiomyomata, also known as uterine fibroids, are non-cancer tumors found in the wall~     of the uterus or womb. Uterine fibroids are the common cause of surgery (removal of the~     uterus). African American women are 3-4 times more likely to have uterine fibroids. Currently~     there is no effective long-term medical treatment for fibroids. Hormones have been used for~     short-term therapy, but they are not used long-term because of the risk of side effects. When~     women stop receiving the hormone therapy often fibroids return. Surgery is the common~     treatment for women who are suffering from abnormal symptoms caused by fibroids. Hysterectomy~     is an effective treatment, however women cannot have children after removal of the uterus.~      Epigallocatechin Gallate (EGCG) is one of the main natural chemicals found in green tea..~     Research the investigators have done in the laboratory and in animals leads them to believe~     EGCG may decrease the growth of fibroids.~      This study is intended to determine whether EGCG will cause fibroid tumors to shrink and~     reduce fibroid related symptoms such as abnormal vaginal bleeding and pelvic discomfort.~   "
172154|NCT01311856|"~     The goal of this behavioral research study is to learn if an internet or phone based exercise~     and weight management program can help cancer survivors to lose weight and change their~     eating and exercise behavior.~   "
172155|NCT01311830|"~     This study will develop an intervention for adults who want to support a smoker. The goal of~     the intervention is for the support person to motivate & encourage their smoker to call the~     state Quitline funded by Minnesota ClearWay. The study will examine the efficacy of a~     telephone based intervention for support persons compared to a self-help intervention~     (written materials only).~   "
172156|NCT01311817|"~     This project is a pilot safety and immunogenicity study of transcutaneous vaccination with~     live attenuated Listeria monocytogenes BMB72 bacteria (actA/plcB-deleted, expressing~     influenza A nucleoprotein) and a cutaneous adjuvant, native purified cholera toxin.~     Transcutaneous vaccination is needle-less application of materials directly to the skin.~     Healthy adult volunteers (4 per group) will receive either:~        -  Saline (placebo)~        -  Cholera toxin adjuvant alone~        -  L. monocytogenes BMB72 bacteria alone~        -  L. monocytogenes BMB72 bacteria plus Cholera toxin adjuvant~      Vaccine solutions will be applied to the upper deltoid area under a standard Tegaderm~     dressing. Key primary endpoints include: safety as measured primarily by clinical findings~     (VS, cutaneous exams, and systemic reactions), and immune responses as measured by~     serological responses to L. monocytogenes, influenza A nucleoprotein, CT, and IFN gamma~     ELISPOT responses to listeriolysin and nucleoprotein peptides. Local skin immune responses~     will be evaluated by skin biopsy in subjects who agree to that (optional). The study will~     begin with 2 roll-in subjects receiving both L. monocytogenes and CT.~   "
172157|NCT01311804|"~     Primary Research Objective:~      The primary objective of this study is to determine efficacy of periarticular parecoxib~     sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management~     in total knee arthroplasty~      Secondary Research Objective:~        -  To determine if perioperative use of parecoxib sodium was associated with improved~          clinical outcomes~        -  To evaluate the safety, in terms of adverse events; serious adverse events and~          tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail~   "
172158|NCT01311791|"~     This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The~     purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular~     augmentation and restoration in patients with dilated cardiomyopathy. Algisyl-LVR™ will be~     injected into the myocardium under direct visualization during the surgical procedure.~      This study will evaluate the concept that direct mid left ventricular (LV) intramyocardial~     injections of Alginate hydrogel implants into the free wall of the failing LV will reduce LV~     size, restore LV shape, lower LV wall stress and improve global LV function.~      The Primary Efficacy Endpoint of the study is the change in Peak VO2 (maximum oxygen uptake)~     from baseline to 6 months of follow-up. The Primary Safety Endpoint of the study is to~     estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device~      The hypothesis of the study is that there is a statistically significant difference in change~     in Peak VO2 from baseline to 6 month follow-up when the medically managed arm is compared to~     the Algisyl-LVR arm, i.e. the Algisyl LVR arm is superior to medical management.~   "
172161|NCT01311752|"~     This study is a Multicentre cohort study with inclusion throughout the full duration of the~     study.~      The primary objective is the study of human papillomavirus related genital pathology in HIV~     positive women.~      The secondary objective are:~        1. To study the characteristics of HPV infection and related disease in the context of long~          term HAART and HIV infection ;~        2. To study the characteristics of atypical cells of uncertain significance detected in Pap~          smears, whose prevalence has dramatically increased in the last years;~        3. To describe cervical cancers observed in the cohort~        4. To study the evolution of recurrent high-grade lesions after surgery~        5. To describe the evolution of vaginal lesions developed after hysterectomy for high-grade~          lesions ;~        6. To describe the specific aspects of surgery for the treatment of cervical lesions~          according to the specific localization in the endocervix in HIV-positive women ;~        7. To study the in situ T cell HPV specific response in cervical lesions and the~          relationship between virological and clinical parameters, host immune status and natural~          history of lesions ;~        8. To initiate a prospective study on anal HPV infection and related disease among women~          infected with HIV.~        9. To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of~          immunosuppression and a high rate of HPV infection ;~   "
172162|NCT01311739|"~     The purpose of this study is to assess and compare the pharmacokinetics (PK) of~     cyanocobalamin after the oral administration of Eligen® B12 (cyanocobalamin/SNAC), oral~     cyanocobalamin alone (commercially-available formulation) and cyanocobalamin administered~     intravenously (IV) (also a commercially-available formulation) to healthy male subjects under~     fasting conditions. The safety and tolerability of oral Eligen® B12 (cyanocobalamin/SNAC)~     versus oral cyanocobalamin alone and versus IV cyanocobalamin are also assessed.~   "
172163|NCT01311713|"~     CEP-9722 is an inhibitor of poly-adenosine diphosphate (ADP) ribose polymerase -1 and -2~     (PARP). The primary purpose of this study is to (Part 1) determine the maximum tolerated dose~     (MTD) of CEP-9722 administered daily to patients with advanced or metastatic solid tumors,~     (Part 2) to evaluate the safety and tolerability of that dose, and to investigate whether~     CEP-9722 has antitumor activity as a single agent.~   "
172164|NCT01311700|"~     The purpose of this study is to test whether early pre-reperfusion metoprolol administration~     in patients suffering and acute myocardial infarction might reduce the size of myocardial~     necrosis.~   "
172165|NCT01311687|"~     The purpose of this study is to compare efficacy and safety of pomalidomide in combination~     with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or~     relapsed and refractory multiple myeloma.~   "
172166|NCT01311674|"~     The purpose of this study is to vaccinate plasmapheresis donors for collection of high titer~     plasma to be used in the manufacture of Hepatitis B Immune Globulin (HBIG).~   "
172167|NCT01311661|"~     This study will compare efficacy and safety of different regimens of olodaterol~     administration in asthma (once daily, twice daily) with placebo in a complete cross-over~     design each within one of the two daily dose groups (medium or high daily dose).~   "
172168|NCT01311648|"~     The objective of the study is to demonstrate the safety and efficacy of treatment with~     BAY81-8973 for prophylaxis and breakthrough bleeds in children with severe haemophilia A.~   "
172169|NCT01311635|"~     The purpose of this study is to study the relative bioavailability of AZD1981 when using a~     new tablet compared to the current tablet.~   "
172170|NCT01311622|"~     The purpose of this study is to determine whether fostamatinib influences the plasma~     concentration of warfarin and changes its blood thinning effect, and to investigate how safe~     and tolerable it is when administered with warfarin.~   "
172171|NCT01311609|"~     This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the~     physical effects of Systane Lubricant Eye Drops.~   "
172172|NCT01311596|"~     This cohort observation, randomized controlled trial is intended to provide data that icons~     and non-verbal communication improve communication and cooperation with children with~     Autism/communication delay and aid in the transition to an unfamiliar environment. It would~     lay the foundation for future studies and practices of using icons and pictures for the whole~     office visit to enhance communication between the patient and physician/nurse/medical staff~     and cooperation of the patient.~        1. Use icons during triage/check in process to decrease time and increase patient~          compliance. Compare typical children to those with Autism/communication delay.~        2. Use icons during blood draw to improve communication with patients, to help with patient~          understanding, and increase patient cooperation and decrease noise and length of~          procedure.~   "
172173|NCT01311583|"~     Patient education using Teach Back has the potential to increase self-care behaviour in heart~     failure (HF) patients and reduce adverse clinical outcomes. Teach back is an interactive~     teaching method that uses plain language, focuses on key points, and asks the patient to~     verbally recall information just discussed. Questions are asked to confirm patient~     understanding of the information delivered.~      This pilot study will be conducted to evaluate the effectiveness of teach back on self-care~     (as measured by the European Heart Failure Self-Care Behaviour Scale- EHFScBS) and determine~     if teach back affects the number of ER visits and re-admissions post discharge. The study~     will also assess if teach back technique is a feasible, acceptable and sustainable method of~     discharge teaching for hospitalized HF patients at St Michael's.~   "
172174|NCT01311570|"~     The primary objective of this study is to assess the therapeutic effect of Buprenorphine in~     MDD population.~      The secondary objectives of this study are to assess the therapeutic effect, the feasibility~     and safety of buprenorphine in a MDD population.~   "
172176|NCT01311544|"~     The Magnetic Resonance angiography (MRA) of supraaortic vessels is essential for the~     etiologic of stroke. However, the techniques usually used provide only static evaluation~     (degree of stenosis, occlusion) but not dynamic. An ultra-fast 3D MRA originally developed~     for the cardiac imaging, k-t blast (Broad-use Linear Acquisition Speed-up Technique) could be~     used to review the supraaortic vessels. This MRA offers the following advantages: short~     acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic~     arteries), 3D spatial resolution and high temporal resolution. These qualities are even more~     optimal with a high magnetic field (3T). The high temporal resolution is interesting because~     it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of~     vascular filling and to assess the vascular supply of the infarcted territory. This sequence~     is classified as a 4D MRA.~   "
172178|NCT01311518|"~     The objective of this study is to evaluate the safety and tolerability of two active doses of~     RGN-352 (thymosin beta 4, Tβ4, Injectable Solution) in patients with acute myocardial~     infarction receiving percutaneous coronary intervention angioplasty with or without stent~     placement. Approximately 75 subjects will be randomized to receive one of two RGN-352 doses~     of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3~     consecutive days and weekly for 4 more weeks.~   "
172179|NCT01311505|"~     This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2~     Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer~     Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg~     rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to~     determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these~     subjects.~   "
172180|NCT01311492|"~     Exercise Trial for Alzheimer's Disease(EXTRA) is a pilot randomized clinical trial involving~     a physcial activity program versus a healthy lifestyle program, with one year follow-up in 30~     non-disabled, community-dwelling persons, age 65 and older.~   "
172181|NCT01311479|"~     The proposed study will evaluate the effectiveness of Osteopathic manipulation of the~     sacro-iliac joint (SIJ) and the lumbar spine in symptomatic female interstitial cystitis (IC)~     patients with sacro-iliac joint dysfunction.~      It is predicted that Osteopathic manipulation for a period of 12 weeks will result in~     subjective indices of increased comfort and objective indices of lower O'Leary-Sant~     Questionnaire, Pelvic Floor Impact Questionnaire (PIFQ-7), Female Sexual Function Index~     (FSFI) and SF-12 scores, lower visual analog scores for pain and urgency, decreased frequency~     on voiding diary and greater variation in resting/contraction perineometry scores.~   "
172182|NCT01311466|"~     Patients with uveal malignant melanoma with liver metastases have median survival of less~     than 12 months. There is no established treatment showing increased overall survival. The~     study will determine if liver transplantation will result in long term survival in patients~     with liver metastases from uveal malignant melanoma.~   "
172183|NCT01311440|"~     In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat~     children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a~     treatment option for children up to 18 years.~      We now initiate an open, prospective, randomized and controlled study with the aim to test~     the efficacy of treatment with modified Atkins diet in adults with focal and generalized~     epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients~     on a permanent basis.~   "
172184|NCT01311427|"~     Data from two recent Tai chi studies have found that Tai Chi yields symptomatic benefit in~     patients with fibromyalgia (FM). The purpose of this study is to confirm those findings in a~     larger randomized, controlled clinical trial in a community-based setting. We also sought to~     extend this line of inquiry by closely examining Tai chi's effect on physical function,~     specifically postural stability. Towards these ends, we conducted a single-blind, randomized~     controlled clinical trial of an FM modified 8-form Yang-style Tai chi program compared to~     standard education. Subjects in both conditions meet in small groups two times weekly for 60~     minutes over 12 weeks.~   "
172185|NCT01311414|"~     During clamping of one internal carotid artery for endarterectomy, blood flow through this~     vessel has to be compensated by collateral arteries including the contralateral internal~     artery and vertebral arteries. In 7 % of all patients undergoing carotid endarterectomy this~     collateral flow is not sufficient to maintain adequate cerebral perfusion during clamping and~     ischemic brain damage is likely to emerge. To maximize cerebral blood flow during clamping,~     increase of blood pressure is a common procedure and routine at our institution. Increasing~     blood pressure can be enabled by tapering a mixture of Cafedrine und Theodrenalin (Akrinor®)~     until the designated blood pressure is reached. After declamping, the blood pressure has to~     be reduced to normal values to avoid postoperative hyperperfusion syndrome. This is enabled~     by tapering urapidil until normal blood pressure is achieved.~      It has been shown that cerebral oxygenation measured by near infrared spectroscopy is reduced~     by intravenous application of norepinephrine. Otherwise, intravenous nitroglycerine increases~     cerebral oxygenation during cardiopulmonary bypass. Hence, cafedrine/theodrenalin and~     urapidil may also have an effect on cerebral perfusion. In this prospective randomized study~     the effect of cafedrine/theodrenalin and urapidil on cerebral oxygenation measured by near~     infrared spectroscopy is investigated.~   "
172186|NCT01311401|"~     The aim~      The aim of the present study is:~        1. The metabolic risk factors that can predict diabetes after 10 years in a Circassians~          population-based sample of people who were aged 35 years or older and living in Israel.~        2. To define the incidence of type 2 diabetes mellitus in Circassians minority in Israel.~      The hypothesis of the study:~      High fasting glucose has the most powerful predictive value for type 2 diabetes mellitus in~     the future.~      The claimed importance of the study:~      Finding a powerful risk factor for future diabetes mellitus can contribute to intensifying~     the preventive measures in a small part of the population, by that to reduce the incidence of~     new diabetes without increasing the health cost.~   "
172187|NCT01311388|"~     The investigators want to achieve the goal of diagnosis in early phase, accurate treatment~     and existence for a long period in order to screen in early phase, diagnose in clinical~     trial, choose treatment and evaluate prognosis of cancers by establishing molecular pathology~     tools.~   "
172188|NCT01311375|"~     The objective of this study is to evaluate the effect of omega 3 fatty acid on neurological~     recovery, lipid profile and Antioxidant system in patients with spinal cord injury. One~     hundred spinal cord injured patients who come to clinic of spinal injury repair research~     center selected. Then the patients will receive two supplements capsules of omega 3 (600 mg)~     in the intervention group and placebo in the control group. Primary outcome measures are~     professionals evaluation of neurological function by using :~        -  ASIA scale for sensory and motor function~        -  FIM scale for Functional potential~        -  FAM~        -  SF_36 for quality of life~      Lipid profile and Antioxidant profile evaluation by using:~        -  FBS~        -  2hpp~        -  Insulin~        -  LDL~        -  Total cHOL~        -  TG~        -  HDL~        -  Leptin Adiponectin -Calcium-~        -  25OHD~        -  PTH,LH, FSH, Prolactin,Testosterone in males Bone markers by serum levels of~          :Osteocalcin-Osteoprotegrin_Bone Specified ALP- CTX - RANKL~        -  BMD~   "
172192|NCT01311323|"~     MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary~     artery disease and/or with left main narrowing who present symptoms of acute ischemia. For~     such kind of patients according to current ACC/AHA guidelines CABG (surgical~     revascularization) is recommended as a treatment method. In comparison with CABG, recent~     studies have shown that PCI (percutaneous coronary intervention) is associated with a lower~     rate of periprocedural adverse events and similar long term event-free survival in patients~     with left main disease. Our latest non randomized registry and randomized LEMANS study,~     comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings.~     LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA~     (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward~     lower one year mortality after PCI when compared with CABG. It should be stressed, that acute~     ischemia substantially increase the risk of CABG. In fact, there are limited data on the~     outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS).~      Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included~     mainly patients with stable angina, small cohort of patients with unstable angina and they~     excluded patients with non ST elevation Myocardial infarction.~      In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low~     perioperative risk (logistic EUROSCORE <5) and ACS patients routinely excluded. High~     perioperative risk patients were included only in PCI registry.~   "
172193|NCT01311310|"~     This study is conducted in order to evaluate the effect of remote ischemic preconditioning on~     children undergoing cardiac surgery, especially focusing on possible differences according to~     preoperative cyanosis.~   "
172194|NCT01311297|"~     A single- center prospective observational study. This study evaluates different aspects of~     endothelial function. It investigates the endothelial leakage with the venous occlusion~     plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.~   "
172195|NCT01311284|"~     Nasotracheal intubation is usually required in oral surgery to allow an unrestricted surgical~     approach. The standard method is generally performed using the Macintosh laryngoscope~     supported by Magill forceps. However, it is recommended to perform awake tracheal intubation~     in situations where a difficult airway is predicted, a scenario where this technique may be~     poorly tolerated by the patient. Although fibreoptic intubation is considered the gold~     standard, sometimes it is difficult to perform and,therefore, alternatives are necessary.~     The hypothesis is that optical laryngoscopes as the Airtraq nasotracheal and Mcgrath can~     improve the time and/or success of nasotracheal intubation in a manikin.~   "
172196|NCT01311271|"~     The aim of this multicentric double blind study (randomized study) is to demonstrate the~     relationship between the amount of rTMS and the efficacy in the treatment of upper extremity~     motor deficits of stroke patients.~   "
172197|NCT01311258|"~     This study is being performed to develop assays to determine the impact of the therapy~     patients receive for treatment of AML or MDS and to determine if these tests can identify~     those patients who are at a greater risk for having their disease relapse.~   "
172198|NCT01311245|"~     The aim of the randomized controlled trial was to test two behavioral interventions among~     job-seekers with risky drinking. The interventions differed in their theoretical background:~     Intervention A was tailored to the stage of change, and Intervention B was~     non-stage-tailored. Over 12 months, job-seekers were pro-actively screened for risky drinking~     at three job-agencies. Job-seekers with risky drinking were asked to participate in the~     study. All three groups were assessed at baseline, and 3, 6 and 15 months later. The baseline~     assessment was self-administered using handheld computers. The follow-up assessments by~     interviews on the phone, primarily. Both intervention groups received individualized computer~     generated feedback letters at baseline and 3 months later.~   "
172199|NCT01311232|"~     This study is a retrospective analysis to identify factors influencing hepatitis B virus~     reactivation in patients treated with rituximab containing chemotherapy. Rituximab monoclonal~     antibody targeting CD20 induces B-cell depletion resulting in prolonged immune suppression.~     This leads to frequent reactivation of patients with a previous history of exposure to HBV or~     HBV carrier.~      We collect the clinical features and laboratory findings of patients satisfied the inclusion~     criteria as follows.~        1. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or \ follicular B-cell~          lymphoma (FL).~        2. Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a~          primary treatment~        3. Patients with a history of previous exposure to HBV~             -  HBV surface antigen (HBs Ag) positive Or~             -  HBV core antibody (IgG anti-HBc antibody) positive~      Then, we compare the HBV reactivation group with the control group (HBV reactivation does not~     happen) to find factors influencing HBV reactivation.~   "
172200|NCT01311219|"~     Patients with acute, displaced fractures of the middle third of the clavicle will be randomly~     assigned into either the non-operative treatment group or the operative treatment group. The~     operative treatment group will be randomly assigned to repair with either an intramedullary~     device or a plate and screws.~   "
172201|NCT01311206|"~     The objective of the proposed research is to assess the efficacy of an eight-week, efficient~     and tolerable, low-intensity resistance-training program with concurrent application of~     partial blood flow restriction (PBFR) for improving quadriceps strength and volume in women~     with risk factors for incident symptomatic or progressive knee OA. This specific aim will be~     achieved through a randomized, controlled trial, comparing low intensity training with and~     without PBFR. There have been numerous reports of exercise interventions in people with knee~     osteoarthritis. However, this research is novel in that it will be the first to use a low~     intensity regimen that will minimize forces on the knee while still having the potential to~     lead to clinically meaningful strength gains in older adults with risk factors for incident~     symptomatic or progressive knee OA.~   "
172210|NCT01311089|"~     Most patients with thyroid tumors are effectively treated surgically by practitioners~     experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing~     thyroid surgery are concerned about the postoperative cosmetic appearance of the neck.~     Robotic thyroidectomy which can hide the operative scar was associated with a higher degree~     of patient cosmetic satisfaction.~   "
172211|NCT01311076|"~     The purpose of this study is to compare the safety, tolerability, pharmacokinetic and~     pharmacodynamic properties of single doses of TAK-329 with a single dose of a~     subcutaneously-injected rapid-acting insulin analog in participants with type 1 diabetes~     mellitus.~   "
172202|NCT01311193|"~     Individuals with borderline personality disorder (BPD) frequently suffer from emotional~     instability, daytime fatigue and sleep disturbances. The investigators examined circadian~     rhythms, sleep and well-being in women with BPD under their habitual life conditions with and~     without light treatment.~      Treated women diagnosed with BPD were investigated during 3 weeks without and 3 weeks with~     morning LT. Rest-activity cycles were continuously measured using wrist actigraphy, together~     with proximal skin temperature. Saliva samples were collected weekly to determine the diurnal~     melatonin rhythm. A range of self-ratings and questionnaires were used to assess depression~     and clinical state throughout the 6-week protocol. Ten matched healthy women followed the~     same 6-week protocol without light treatment.~   "
172203|NCT01311180|"~     Sensoril - Extracts of Withania somnifera (Ashwagandha in Ayurvedic Medicine) have shown~     potent anti-stress, cortisol lowering, GABAergic, serotonergic and antioxidant properties in~     animal and human studies. Furthermore, controlled, single site human studies have shown the~     anxiolytic potential of WS extracts.The present study is a Phase II Double-Blind, Parallel~     Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients with~     Generalized Anxiety Disorder. The primary objectives of this study are to assess the efficacy~     and safety of Sensoril® for patients with moderate or greater severity of symptoms associated~     with Generalized Anxiety Disorder.~      The Primary Efficacy endpoint in this study will be determined by a statistically~     significantly greater improvement from baseline to endpoint in total Hamilton Anxiety Scale~     scores in the Sensoril® treated group versus those receiving placebo.~      The secondary endpoints in this study will assess if Sensoril® treatment rather than placebo~     results in:~        1. Greater response rates (≥ 50% improvement in HAM-A total scores from baseline to last~          value)~        2. Greater remission rates (HAM-A total scores ≤ 7) at week 8~        3. Greater improvement from baseline to week 8 in HAM -A psychic and somatic anxiety~          cluster scores.~        4. Greater improvements on CGI - severity scores from baseline to last value.~        5. A higher percentage of subjects rated as much improved or very much improved on the~          CGI - Improvement subscale at the last value.~        6. Serum cortisol and DHEA-S levels will be assessed between the two treatment groups.~          These biomarkers are indices of stress and it is hypothesized that improvement in levels~          of these stress indices will favor the Sensoril® treated group.~      Exploratory Endpoint~      1. Patient reported outcomes for sleep and calmness will be assessed between the two~     treatments.~      Safety Endpoint~      The safety endpoints will be determined by assessments of adverse and serious adverse events,~     physical examination, vital signs, EKG, and clinical laboratory measures. Clinical measures~     with laboratory defined reference ranges and vital signs will be assessed.~   "
172204|NCT01311167|"~     Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is~     possibly related to the increased effect of steroid hormones on salt reabsorption in the~     kidney. By reducing overall steroid production with the dexamethasone the accumulation of~     salt and water could be prevented.~   "
172205|NCT01311154|"~     The proposed study is distinctive in studying known carriers of resistant Enterobacteriaceae.~     It examines both phenotypic and genotypic expansion in the AMR bacterial population as a~     function of antibiotic treatment, and examines the effect of antibiotics on the dissemination~     of resistance genes from species to species. It will examine CRE, important emerging~     pathogens, which are a significant threat to public health, but yet not well studied. The~     proposed study will use an interdisciplinary approach, combining PK/PD, phenotypic, and~     genetic data to understand the effect of antibiotics on the likelihood of spread of AMR. Most~     previous studies have focused on the effect of antibiotic agents on clinical detection,~     infection or acquisition of AMR among non-carriers67,68. Other studies have looked at the~     effects on colonisation-resistance mostly among healthy volunteers69. Very few studies have~     examined the effects of various antibiotic agents on carriers of ARB and those focused~     primarily on vancomycin resistant enterococci (VRE)70. No similar studies have been conducted~     with regard to ESBL or to CRE. Correlation with clinical factors and environmental~     contamination has not been determined in previously published studies. The proposed study~     also extends the analysis to the effect of antibiotic treatment on dissemination of~     resistance genes which may be of great importance as these events may lead to emergence of~     new AMR strains and species. The proposed study not only examines the effects of various~     antibiotic agents and classes, but also the effects of duration of treatment and PK/PD~     indices on amplification of ARB. The study will also examine the effect of antibiotics on the~     epidemicity and fitness of colonising strains~   "
172206|NCT01311141|"~     In the present study we will measure and compare the unbound, i.e. microbiologically active~     concentrations of doripenem after a single dose of 500mg in plasma, subcutaneous adipose~     tissue and muscle tissue and saliva of healthy volunteers. We will use the microdialysis~     technique, which allows for the continuous measurement of unbound drug concentrations in the~     interstitial space fluid. The findings of the present study will help to assess whether~     currently employed therapy regimens with doripenem provide effective antimicrobial~     concentrations in different compartments in man~   "
172207|NCT01311128|"~     This protocol will test a new non-invasive device, the T-line, in continuously determining~     heart rate and blood pressure in operative and critically ill patients. The accuracy of the~     device will be compared to the standard radial artery catheter, as well as to the~     non-invasive blood pressure cuff. The T-line will also be compared to the right heart~     catheter determining cardiac output in at least 20 patients.~      Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as a~     standard radial arterial catheter and a blood pressure cuff in perioperative patients.~   "
172208|NCT01311115|"~     This study proposes a novel behavioral intervention to help smokers in Thailand to achieve~     their goals of quitting. Smoking treatment programs are rare throughout most of Asia and~     unlikely to meet the impending demand for quitting that tobacco control regulations is~     stimulating. New approaches are needed.~      The present study is a randomized controlled trial to test the effectiveness of a novel,~     scalable approach to smoking cessation that is targeted toward rural Southeast Asian~     communities. Thailand is used as a test case to explore if pairs of smokers quit successfully~     after making financially-backed commitments and receiving cash incentives to quit. The~     control group receives education and counseling about quitting. In addition to education and~     counseling about quitting, the intervention includes two key components:~        1. Each participant is encouraged to deposit his cigarette money on a weekly basis, to be~          returned only if the smoker quits successfully within three months. Such commitment~          contracts, based on theory from behavioral economics, are designed to help a person to~          maintain self-control and motivation in the face of temptation.~        2. Each participant is paired with another study participant. If both quit, each receives a~          cash bonus. The joint incentives are designed to lead partners to support each other~          throughout the quit attempt.~      Thus, group commitment contracts marshal a robust blend of elements: financial commitment,~     social support, peer pressure, and monetary rewards. A larger, follow-up evaluation will~     clarify the relative importance of each of these elements.~   "
172212|NCT01311050|"~     A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with~     Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer~   "
172222|NCT01310920|"~     Evidence has been documented for the close relationship between the arrhythmia pathogenesis~     and the gene expression in renin-angiotensin system. However, it remains unclear for~     involvement of RAS in the pathogenesis of non-familial sick sinus syndrome. The researchers~     thus investigated the possible relationship between non-familial sick sinus syndrome and the~     polymorphism and haplotype of the AGT promoter.~   "
172223|NCT01310907|"~     Bradyarrhythmia, including sinus node dysfunction and atrioventricular block, is a major~     cause necessitating pacemaker implantation. In contrast to familial bradyarrhythmia known as~     by mutations at particular ion channels, limited information is available for the mechanistic~     study in non-familial bradyarrhythmia.~      Possible gene polymorphisms related to non-familial bradyarrhythmia were studied. Comparison~     of multi-locus analysis and single-locus analysis will be analyzed between the cases and~     controls. Functional studies will perform to clarify the results of association study.~   "
172224|NCT01310894|"~     The aims of this study are:~        -  to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on~          the rate of absence of definite cancer using patients on active surveillance as a~          comparison (co-primary objective A) and~        -  to determine the difference in rate of treatment failure associated with observed~          progression of disease from low risk prostate cancer to moderate or higher risk prostate~          cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance~          (co-primary objective B).~   "
172225|NCT01310881|"~     This is a subject single blinded, randomized, placebo-controlled, single dose,~     first-time-in-human study with three or more ascending cohorts.~   "
172226|NCT01310868|"~     RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     radiation therapy and temozolomide after surgery and Gliadel wafer may kill any tumor cells~     that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects of fluorescence-guided surgery with~     5-ALA given together with Gliadel wafer, followed by radiation therapy and temozolomide, in~     treating patients with primary glioblastoma.~   "
172227|NCT01310855|"~     RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not~     yet known whether cediranib maleate given together with gefitinib is more effective than~     cediranib maleate given alone in treating patients with recurrent or progressive~     glioblastoma.~      PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib~     maleate together with gefitinib and to see how well it works compared with giving cediranib~     maleate together with a placebo in treating patients with recurrent or progressive~     glioblastoma.~   "
172228|NCT01310842|"~     The goal of this study is to learn about the influence of the social and physical environment~     on smoking cessation (quitting smoking) among smokers.~   "
172229|NCT01310829|"~     The goal of this study is to evaluate a virtual reality-based intervention for training~     health care providers who are not genetics specialists to effectively communicate with and~     counsel patients regarding cancer genetics.~   "
172230|NCT01310816|"~     IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in~     patients with Chondrosarcoma.~   "
172231|NCT01310803|"~     This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the~     efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with~     valrubicin following induction with valrubicin as compared to induction with valrubicin only~     in subjects with CIS of the bladder. The randomization will be 1:1 and subjects will be~     stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last~     bacillus Calmette-Guerin (BCG) failure (>1 year vs. <1 year).~   "
172232|NCT01310790|"~     The impact of lactate guided therapy on septic shock has not been extensively investigated,~     however the goal directed therapy has been used for years. The investigators aim was to test~     the hypothesis that lactate directed hemodynamic therapy is associated with improving the~     outcome of patients with septic shock by comparing different goal directed strategies which~     have been commonly recommended clinically.~      In this multicenter, randomized trial, the investigators assigned patients with septic shock~     to three groups: Patients were treated with hemodynamic therapy directed either by~     conventional parameters treatment (control group), or central venous oxygen saturation~     (ScvO2), or blood lactate respectively in each group. The primary outcome was the rate of~     death at 28 days after randomization and in-hospital mortality; secondary end points include~     hemodynamic states, time to goal-achievement.~   "
172233|NCT01310777|"~     The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine~     in lowering intraocular pressure (IOP) relative to each of its individual active components~     in patients with open-angle glaucoma or ocular hypertension.~   "
172234|NCT01310764|"~     The purpose of this study is to investigate the safety and efficacy of bevacizumab as an~     adjunctive treatment to trabeculectomy in open angle glaucoma patients and to compare this~     new drug to the most commonly used anti-scarring agent, mitomycin C.~   "
172235|NCT01310751|"~     The aim of this study is to determine whether inhaled iloprost can be used to prevent and~     treat PH and PHC while in children after operation of CHD~   "
172236|NCT01310738|"~     This study is aimed to compare the efficacy and safety of medications currently used in~     Brazil for treatment of visceral leishmaniasis. The investigators will compare the effects of~     meglumine antimoniate, two formulations of amphotericin B: deoxycholate and liposomal, and a~     combination of meglumine plus the liposomal amphotericin B formulation. The study is designed~     to demonstrate the difference in efficacy measured as cure rate at six months after treatment~     and the safety profile based on the adverse event rate observed with each intervention.~   "
172237|NCT01310725|"~     The aim of the study is to evaluate the patency in different kinds of vessels used as graft~     material in coronary artery bypass grafting.~      The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the~     same, or better, patency compared to radial grafts and that skeletonisation of the left~     internal mammary artery does not effect the patency for this graft.~   "
176637|NCT01253122|"~     A randomised four way crossover design in which each subject will receive two dose levels of~     TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised order.~   "
172241|NCT01310673|"~     Medical teaching suggests allopurinol should not be initiated in the setting of an acute~     attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests~     the hypothesis that there is no difference in patient reported daily pain or flair~     occurrences with early versus delayed institution of allopurinol during an acute gout attack.~   "
172242|NCT01310660|"~     Prospective studies to date have identified that the levator ani muscle injuries occur in~     14-19% of women after vaginal delivery.~      In none of studies a vaginal examination was performed at the time of delivery. It has~     previously been shown that sonographic injuries of the anal sphincter that were believed to~     be occult were in fact clinically apparent but not recognised at the time of delivery. It is~     therefore important to correlate clinical findings to ultrasound images.~      3D endovaginal endosonography has not previously been used to identify levator injuries. This~     should potentially provide a better view of the pelvic floor muscles.~      The relationship between levator injury and symptoms of pelvic floor dysfunction has not been~     previously established using validated questionnaires. In this study, we include validated~     questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As~     symptoms may become apparent only in the long term it is prudent that the women are followed~     up in the long term.~      The principle objective is to establish the incidence of levator muscle defects during~     pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and~     damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic~     organ prolapse.~   "
172243|NCT01310647|"~     The aim of this study is to compare the effectiveness of testosterone,estradiol and a~     combined treatment with estrogens/progestagens prior to IVF-ICSI in previously diagnosed low~     responder patients.~   "
172244|NCT01310634|"~     The overall goal of this project is to elucidate the epidemiology of anxiety and depression~     in parents of hospitalized neonates and test a comprehensive intervention program to prevent~     anxiety and depression in parents in this setting.~   "
172245|NCT01310621|"~     The purpose of this study is to evaluate the role of surfactant lung lavage in the treatment~     of meconium aspiration syndrome. Aspiration of meconium into the tracheo-bronchial tree with~     the onset of respiration results in meconium aspiration syndrome (MAS). Aspirated meconium~     inhibits surfactant function directly and also decreases its synthesis by its toxic effects~     on type 2 pneumocytes. There is no specific treatment recommended for meconium aspiration~     syndrome. Numerous studies have shown that exogenous surfactant improves outcome in babies~     with meconium aspiration. Surfactant replacement alone does not remove meconium from airways~     and multiple doses may be required .Therefore an effective therapy to improve outcome is~     crucial in treating infants with meconium aspiration. Surfactant Lung lavage has been shown~     to be alternative to bolus therapy in treating neonates with meconium aspiration as shown by~     many pilot studies. So the investigators have decided to study the role surfactant lung~     lavage in the treatment of meconium aspiration syndrome.~   "
172246|NCT01310608|"~     Patients undergoing cardiac surgery frequently develop neurologic complications, ranging from~     subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of~     complications is commonly caused by embolization in the brain due to manipulation of~     atherosclerotic parts of the aorta ascendens (AA) during surgery. Timely detection of AA~     atherosclerosis before surgery enables the surgeon to consider changes of the surgical plan,~     to reduce the risk of embolization and thus subsequent neurologic complications.~      Various methods exist to visualize the AA to detect atherosclerosis. Epiaortic ultrasound~     scanning has become the gold standard, but is seldom used as it interferes often with~     surgical plan and can only be used after sternotomy. Transesophageal echocardiography (TEE)~     is a widely used imaging method permitting evaluation of the aorta preoperatively, but~     assessment of distal AA is hampered by interposition of air-filled trachea between esophagus~     and AA. The A-View® (Aortic-view) method, a modification of conventional TEE using a~     fluidfilled balloon, overcomes this limitation. The safety and diagnostic accuracy of the~     A-View® have successfully been shown in previous studies. The hypothesis of this study is~     that the use of A-View will reduce cerebral embolization secondary to a change of surgical~     technique.~   "
172247|NCT01310595|"~     To investigate the effect of cervical manual mobilization on head repositioning accuracy and~     postural balance in patients with chronic mechanical neck pain in a randomized controlled~     trial. Hypothesis: There is no difference between the intervention group (manual~     mobilization) and control group head repositioning accuracy and postural balance.~   "
172248|NCT01310582|"~     Numerous studies demonstrate that patients have improved immediate recovery characteristics~     following desflurane anesthesia compared to other volatile agents, including sevoflurane.~     There is limited evidence in the literature to suggest that patients undergoing sevoflurane,~     compared to desflurane anesthesia, may suffer from limitation in function and cognitive~     ability for an undetermined, but prolonged period of time following surgery. These~     differences are not explained pharmacokinetically and may be a result of a direct neurotoxic~     effect of sevoflurane. An unresolved question is the time required for the ability to return~     to complex tasks, such as driving, following anesthesia. Commonly, patients are advised not~     to drive or make important decisions for 24 hours following anesthesia, but this is not~     well-studied and proscribed on an empiric, rather than scientific, basis with very limited~     data available.This study will better define recovery characteristics and characterize the~     severity and duration of cognitive impairment following sevoflurane or desflurane anesthesia~     after brief outpatient urologic surgery in elderly females using tests of cognitive ability~     coupled with performance on a driving simulator and cognitive task tests to objectively~     measure not only testing performance, but also cognitive effort in performing these tests.~   "
172249|NCT01310569|"~     This study aimed to search whether whole body and subcutaneous adipose tissues increase in~     PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.~   "
172250|NCT01310556|"~     This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the~     patients with coronary artery disease and the relationship between different GMDs and~     coronary artery disease (CAD).~   "
172276|NCT01310218|"~     The purpose of the study is to prospectively compare the functional, satisfaction, and wound~     outcomes of patients treated with one of two accepted methods of postoperative dressing~     following carpal tunnel release. Hypothesis: There will be no difference between the short~     term (approximately 2 - 3 days)and longer term (9 to 14 days)bulky dressing groups in terms~     of outcomes.~   "
172251|NCT01310543|"~     Teens and Toddlers is an intervention that enables young people at risk of teenage pregnancy~     to spend time mentoring a toddler as well as participating in counselling and classroom work~     focused on youth development. This trial aims to test primary hypotheses that girls age 13/14~     who are randomly allocated to participate in the T&T intervention are more likely to report~     use of contraception at last sex, less likely to report frequent sex without contraception~     over the previous 3 months, less likely to expect to become teenage parents and more likely~     to report high scores for youth development indicators one year after the intervention than~     are similar girls who are randomised not to participate. The trial involves a total of 180~     girls per arm and is being conducted across England funded by the Department for Education~     and conducted by the London School of Hygiene and the National Centre for Social Research.~   "
172252|NCT01310530|"~     The purpose of this is to determine the efficacy and toxicity of proton therapy when used to~     deliver partial breast radiotherapy in patients with early stage breast cancer with low or~     intermediate risk factors.~   "
172253|NCT01310517|"~     The purpose of the study is to directly compare two methods of evaluating heart function at~     the time of your angiogram. In both methods contrast dye is injected into the main heart~     chamber during the angiogram while x-ray images are taken. One method uses an automatic power~     injector to deliver the normal volume of contrast; the other method uses hand injection of~     very low volume of contrast into the main heart chamber. It is hypothesized that hand~     injection will prove to be an accurate method to estimate ejection fraction (EF) at the time~     of radial coronary angiography when compared directly to Power LV.~   "
172254|NCT01310504|"~     Initially a group of paramedics will be trained to perform FAST (Focused Abdominal Scan for~     Trauma) scans. The paramedics will then enter a simulated mass causality incident and triage~     patients. Volunteers in the study will include peritoneal dialysis patients (non stable)~     and non-peritoneal dialysis patients (stable). They will use the ultrasound to perform FAST~     scans on the patients to determine which subjects are stable and which are unstable~     patients. They will record which patients they consider need transport first. This data will~     be used to evaluate accuracy and speed of the FAST scan. When the paramedic identifies free~     fluid within the volunteer, they will be able to make the decision to upgrade these patients~     and ultimately transport them more quickly. The paramedics will be evaluated for time and~     accuracy with the FAST scan.~   "
172255|NCT01310491|"~     The purpose of this trial is to determine if by structured telephone based health coaching~     programme supported by remote monitoring system among type 2 diabetes, coronary artery~     disease and heart failure patients the investigators are able to improve their quality of~     life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among~     those type 2 diabetes patients who had elevated value of HbA1c when recruited.~   "
172256|NCT01310478|"~     To investigate safety and tolerance of dose-escalation of infusional recombinant human~     endostatin in combination with mFOLFOX6 as initial therapy for patients with metastatic~     colorectal cancer.~   "
172257|NCT01310465|"~     Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone~     mass or low bone mineral density. Among patients with lumbar degenerative disease, some need~     fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the rate~     of bone fusion, reduce the success of bone fusion, and ultimately affect the overall~     effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many researchers~     dispute if zoledronic acid can promote the healing of long bone fractures. But few~     researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we select~     patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. Three~     days postoperatively, the patients were randomized to either one infusion of zoledronic acid~     or sodium chloride intravenously. We follow all these patients for 6 months. During this~     time, we detect bone metabolism and bone fusion of these patients. At last, we can tell if~     zoledronic acid can modify bone metabolism and promote bone fusion.~   "
172258|NCT01310452|"~     Primary objective:~      To compare the change in liver fat content and visceral fat mass (cm2) assessed by MRS~     (Magnetic Resonance Spectroscopy) and MRI (Magnetic Resonance Image), after 26 weeks of~     treatment with insulin detemir once daily or insulin NPH once daily both with metformin in~     overweight and obese type 2 diabetic subjects.~      Secondary objectives:~      To compare the two treatments with respect to:~        1. Efficacy:~             -  MRI: abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose~               Tissue Ratio.~             -  Change in HbA1c from baseline at 12 and 26 weeks of treatment.~             -  Change in Fasting plasma glucose from baseline at 12 and 26 weeks of treatment.~             -  Weight~             -  Waist and hip circumference~        2. Safety:~             -  Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus~               NPH~             -  Lipid profile at the start and after 26 weeks of treatment~             -  Incidence of Adverse events during the trial~             -  Safety profile as measured by laboratory safety parameters (haematology,~               biochemistry) and physical examination/vital signs before and at the end of~               treatment~   "
172259|NCT01310439|"~     The purpose of this study is to examine the neural basis of response inhibition, working~     memory, and sustained attention in adolescents and adults with~     Attention-Deficit/Hyperactivity Disorder (ADHD), with particular emphasis on quantifying the~     effects of methylphenidate (i.e., treatment with psychostimulants) on neural function.~     Participants will undergo electrophysiological measurement of brain function during~     laboratory cognitive tasks. This research is aimed to develop a better understanding of how~     ADHD neural dysfunction relates to clinical presentation and medication response during the~     transition from adolescence to adulthood. The specific aims and hypotheses are:~      Specific Aim: To characterize the effect of Ritalin (methylphenidate) on neural activity~     underlying performance on the response inhibition task in ADHD adolescents and adults.~     Hypothesis 1) Methylphendiate will increase N2 and P3 amplitude in ADHD persons during~     medicated EEG sessions; Hypothesis 2) There will be a significant age × medication~     interaction such that ADHD teens will show increased amplitude of N2 while medicated,~     particularly at frontal sites, whereas ADHD adults will show differentially greater effect of~     medication on P3 amplitude and latency at central sites. Hypothesis 3) Brain activity~     assessed by fMRI will differ between unmedicated and medicated states.~   "
172260|NCT01310426|"~     Vaginal delivery may cause various levels of damage to the anal sphincter. According to the~     literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal~     delivery suffer from fecal incontinence. This has an adverse effect on the quality of life.~     Different risk factors such as: first births, instrumental delivery, high birth weight,~     prolonged second stage, epidural anesthesia etc. were assessed and found to be associated~     with anal sphincter disruption. The purpose of this study is to assess risk factors for anal~     sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D~     transperineal US).~   "
172261|NCT01310413|"~     This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate~     vaccine GSK1557484A in children 6 months to < 18 years of age.~   "
172262|NCT01310400|"~     A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal~     V is as immunogenic as a locally sourced competitor vaccine in young children.~   "
172263|NCT01310387|"~     This study is:~        -  A single-center, randomized, prospective controlled trial.~        -  To prove superiority of active pain management group compared to control group by the~          percent of pain intensity difference of outpatients with lung cancer pain.~        -  204 patients will be recruited.~   "
172264|NCT01310374|"~     An observational clinical study will be performed in subjects aged 12-60 years old to~     describe the dynamic changes of humoral immune/cellular immunity after vaccination of~     influenza vaccine, and to discuss the role of different antibodies against influenza virus~     infection, and to look for possible factors related to side effects with the vaccine.~   "
172265|NCT01310361|"~     In some studies once daily amoxicillin therapy might be treatment of choice for Group A~     β-hemolytic Streptococcus pharyngitis in comparison with three to four times daily treatment~     with oral penicillin V.~   "
172266|NCT01310348|"~     The aim of this study is to investigate whether there is a relation between bone mineral~     density of lower limbs exposed to vibration and the muscle strength gain in the knee~     extensors and flexors, and a relation serum sclerostin level and the muscle strength gain in~     the knee extensors and flexors in healthy young adult women.~      Forty healthy young adult women are planned to include in this study. The participants~     meeting the criteria were randomized into two groups: the training group (20 cases) and the~     Control group (20 cases).~      The whole-body vibration (WBV) training group will be trained on a WBV platform (Power Plate)~     5 times a week for 4 weeks period. Participants will be asked to stand upright on WBV~     platform. Training volume and training intensity will be low at the beginning but progressed~     slowly according to the overload principle. The training volume will be increased~     systematically over the 4-week training period. The training intensity will be increased by~     increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration. The subjects~     will be asked to report negative side effects or adverse reactions in their training diary.~     In the Control group, sham stimulus will be performed by WBV platform 5 times a week for a 4~     weeks period.~      Plasma sclerostin level and, the right and left knee flexor and extensor muscles strength~     will be measured before and after training period. Isokinetic torque will be measured with~     the Biodex (Biodex System 3 PRO Multijoint System Biodex Medical Inc. Shirley/NY~     USA)extremity-testing system. The right and left lower limbs bone mineral density (BMD) and~     muscle strength will be measured before training period. The BMD will be evaluated by bone~     densitometer (Norland XR-46 DXA, USA). Sclerostin levels will be measured by human sclerostin~     ELISA kit.~      The rest muscle electrical activity of right and left knee flexor and extensor muscles will~     be evaluated at pre-vibration, post- vibration and, during vibration. The rest muscle~     electrical activity will be measured by Powerlab (data acquisition system, ADInstruments,~     Australia) device.~   "
172267|NCT01310335|"~     The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin~     level in healthy young adult women.~      Fifteen healthy young adult women are planned to include in this study. All cases will be~     trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week~     period. Training duration will be short at the beginning but progressed slowly.~      The amplitude of vibration will be 2 mm and the frequency of the vibration will be 40 Hz. The~     subjects will be asked to report negative side effects or adverse reactions in their training~     diary.~      Previbration and postvibration (just after, 10.minute and 30.minute) levels of plasma~     sclerostin will be measured on first, second and fifth day of experiment. Sclerostin levels~     will be measured by human sclerostin ELISA kit.~   "
172268|NCT01310322|"~     A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423~     when administered in different ways.~   "
172269|NCT01310309|"~     The purpose of this two part study is the assessment of the performance of the XIENCE V®~     Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific~     setting of patients with Multi-Vessel Coronary Artery Disease (MVD).~   "
172270|NCT01310296|"~     The purpose of this study is to determine the mass balance and absolute bioavailability of a~     single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of~     lofexidine.~   "
172271|NCT01310283|"~     The goal of this study is to address the effectiveness of a modified cavity prevention~     protocol for 5-9 year-old children which emphasizes better diet modification, more frequent~     professional fluoride applications, and xylitol product usage based on individual risk status~     in a 1-year randomized controlled clinical trial in the University of California, San~     Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize~     that the regimen will help to reduce new cavities in children who are at risk for dental~     cavities.~   "
172272|NCT01310270|"~     The hypothesis being tested is that in patients with stable claudication and documented PAD,~     omega-3 supplementation for 1 month will lead to improvement in endothelial function as~     measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the~     vascular inflammatory profile as measured by a panel of established circulating inflammatory~     biomarkers.~   "
172273|NCT01310257|"~     The aim is to improve understanding of the assessment of pain experience in patients with~     osteoarthritis (OA) of the knee. The current study will be divided into two parts. In Study~     1, the investigators will analyse existing questionnaires relevant to the mechanisms and~     therapeutic targets of knee OA to establish discrete dimensions that discriminate between the~     different mechanisms of pain. On the basis of this analysis, the investigators will refine~     the questionnaires to maximise their sensitivity to knee OA. In Study 2, the investigators~     will seek to confirm the factor structure identified in the questionnaires in Study 1 and~     explore potential mediator and moderator variables between pain and quality of life using the~     refined measures. The investigators will also evaluate Quantitative Sensory Testing as a~     predictor of OA knee pain.~   "
172274|NCT01310244|"~     To define Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with~     Paclitaxel plus Carboplatin in Chemotherapy-Naive Patients with Stage IV Non-Small-Cell Lung~     Cancer (NSCLC).~   "
172275|NCT01310231|"~     The purpose of this study is to determine if the addition of metformin to standard~     chemotherapy improves progression free survival in women with metastatic breast cancer.~   "
172278|NCT01310192|"~     The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine (FCH)~     positron emission tomography (PET) as an imaging technique that can be used to delineate~     malignant tumors in the prostate gland. The proposed technique works by measuring the tissue~     metabolism of FCH, a substrate that is preferentially metabolized by cancer cells due to~     malignant over-expression of the choline transporter and choline kinase enzyme. The project~     scope covers a clinical study to recruit men with prostate cancer who have elected treatment~     by radical prostatectomy surgery. These men will undergo pre-operative PET scanning to~     measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging results will be~     compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy~     of F-18 FCH PET for detecting cancerous prostate sextants.~   "
172279|NCT01310179|"~     This study will test whether it is possible to introduce new genetic material into a small~     portion of a tumor and have the product of the new gene not only kill those tumor cells that~     were infected initially, but also the surrounding tumor cells as well with limited or no harm~     to the patient. The desired effects of this approach are achieved by focusing potent~     chemotherapies directly within the tumor itself and, as a result, avoiding injury to the~     remainder of the body. In this study, we will use two components, the first of which is a~     virus, known as an adenovirus, that has been crippled (i.e., it cannot make more of itself)~     and loaded with a bacterial gene called E. coli purine nucleoside phosphorylase (PNP).~     Adenoviruses are considered to be relatively safe vehicles for gene delivery and are~     presently being used in numerous human trials and therapies worldwide, including a head and~     neck cancer therapy approved for use outside the United States. The loaded adenovirus will be~     used to deliver the PNP gene directly into a tumor in patients. This gene is not expected to~     have an effect itself. However, the gene produces PNP inside the tumor and this protein will~     activate the second component of the therapy, a drug called fludarabine phosphate, which is~     approved by the FDA for certain types of blood-cell cancers, but has not been shown to be~     effective against most solid tumors. The proposed therapy gives the patient several infusions~     of fludarabine following the injection of the virus carrying the PNP gene and, as the~     fludarabine enters the tumor, it will be converted by PNP into a second compound,~     fluoroadenine. Numerous studies in mice and rats have shown that fluoroadenine is a very~     potent anti-cancer agent and that it will kill the tumor cells where it is made as well as~     those in the immediately surrounding area.~   "
172280|NCT01310166|"~     The purpose of this study is to investigate which changes in immunological biomarkers under~     treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be~     detected.~   "
172281|NCT01310153|"~     Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective~     Caesarean birth. There has been no study comparing the efficacy of immediately positioning a~     newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by~     Caesarean birth.~      The investigators hypothesize that when the infant is prone they will have postural drainage,~     better dorsal lung expansion, less vagal response from suctioning and less agitation~     secondary to the righting reflex.~      The investigators will compare 1033 term babies divided by randomization into two groups~     prone and supine. The investigators will check for incidence and severity of Respiratory~     Distress, Use of FiO2 or respiratory support, admissions to NICU.~   "
172282|NCT01310140|"~     Studies have shown that people with certain disorders have an increased risk of developing a~     condition called Metabolic Syndrome (MS). In this study, the investigators want to learn more~     about MS among people staying in the hospital for treatment of Major Depressive Disorder~     (MDD) and also Major Depressive Disorder with Psychotic Features (MDpsy). The investigators~     also want to learn more about a stress hormone called cortisol that is made in the body.~     Those who take part in this study will answer some questionnaires, be given some psychiatric~     interviews, and have some blood taken along with a urine sample.~      The investigators believe that patients in the hospital with MDpsy will have higher baseline~     rates of MS factors, cortisol levels, dexamethasone non-suppression, and insulin resistance,~     compared with MDD alone.~   "
172283|NCT01310127|"~     This is a single-center, randomized, investigator-masked, parallel group, and~     active-comparator controlled study investigating the clinical outcomes for visual acuity and~     macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or~     Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subjects who have undergone cataract~     extraction with posterior chamber intraocular lens implantation.~   "
172284|NCT01310114|"~     The primary objective of the study is to assess the safety and tolerability of Human~     Placenta-Derived Cells (PDA001) at 3 different dose levels versus placebo (vehicle control)~     administered intravenously in subjects following ischemic stroke. The secondary objective of~     the study is to assess the effect of PDA001 on improvement in clinical function following~     ischemic stroke.~   "
172285|NCT01310101|"~     The rationale of the study is to explore the safety and efficacy of ofatumumab in combination~     with dexamethasone (O-dex regimen) in patients with refractory/relapsed CLL. Moreover, the~     hypothesis is that this approach will be able to achieve at least the same response rates~     compared with R-dex regimens (historical controls; manuscript submitted to Leukemia), while~     maintaining lower toxicity profile.~   "
172286|NCT01310088|"~     The global epidemic of obesity in childhood continues to evolve and threaten future health~     and life expectancy primarily due to the increased incidence of cardiovascular disease.~     Obesity is strongly related to high blood pressure (hypertension) and both conditions pose a~     risk for target organ damage, which can follow a subject from childhood into adult life. The~     AORTA study will investigate central hemodynamics and organ damage in 100 obese children and~     adolescents in order to gain insight to the complex interplay of hypertension, obesity and~     subclinical damage in order to intensify more precise prevention, thereby reducing the future~     development of cardiovascular disease.~   "
172287|NCT01310075|"~     The goal of this clinical research study is to learn if the complication rate and~     post-surgical appearance differ based on what type of mesh is used for breast reconstruction~     surgery.~   "
172288|NCT01310062|"~     More recent studies have shown that the HBV-infected population has a greater risk of~     development of hepatocellular carcinoma. Nevertheless, there are still a significant number~     of people chronically infected by HBV who do not develop the complication. Hence, there exist~     biological markers that could be indicator for the disease-inducing and carcinogenic~     potential of the virus.~   "
172289|NCT01310049|"~     The purpose of this first-in-man trial is to determine the safety and tolerability of~     ascending single and multiple doses of LEO 32731 in healthy male subjects. The trial will be~     performed in three parts. In Part 1, single doses of LEO 32731 will be administered to~     healthy male subjects. In Part 2, the effect of food on the single oral dose pharmacokinetic~     will be investigated. In Part 3, multiple doses of LEO 32731 will be administered to healthy~     male subjects.~   "
172290|NCT01310036|"~     This open-label, single arm study will evaluate the safety and efficacy of Tarceva~     (erlotinib) as first-line therapy in patients with stage IV or recurrent non-small cell lung~     cancer who harbour epidermal growth factor receptor (EGFR) mutations. All patients will~     receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity~     occurs. At the investigator's discretion, patients may receive Tarceva beyond disease~     progression.~   "
172291|NCT01310023|"~     SMARTT will estimate the incidence of conditions and diagnoses potentially related to in~     utero exposure to antiretroviral therapy and/or exposure in the first two months of life~     among children born of HIV-infected mothers.~   "
172292|NCT01310010|"~     Study hypothesis:~      Treatment with dasatinib 100 mg QD is safe and efficacious when given to patients with Ph+~     ALL in the post SCT setting.~   "
172293|NCT01309997|"~     This randomized phase II trial is evaluating how well imatinib mesylate works compared to~     rituximab in treating cutaneous sclerosis in patients with chronic graft- versus-host disease~     (GVHD). Both imatinib and rituximab have been reported to decrease skin thickening and~     improve skin and joint flexibility in people with cutaneous sclerosis due to chronic GVHD.~   "
172294|NCT01309984|"~     The purpose of this study is to assess the transfer of fospropofol and its active metabolite,~     propofol, to breast milk following administration of LUSEDRA® to lactating women undergoing a~     needed procedure.~   "
172295|NCT01309971|"~     The purpose of this study will allow us to observe and follow the subjects' treatment from~     DPBRN Prevalence of Questionable Occlusal Caries Lesions Study over a 24 month period.~   "
172296|NCT01309958|"~     This study focused on improving the quality of dental care by fostering movement of the~     latest scientific advances into daily clinical practice.~   "
172297|NCT01309945|"~     The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared~     with continued duloxetine in the treatment of patients with treatment resistant depression~     (TRD).~   "
172298|NCT01309932|"~     The purpose of this study is to determine if combination therapy with Pegylated Interferon~     Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or~     BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC)~     compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48~     weeks.~   "
172299|NCT01309919|"~     The purpose of the study is to determine the feasibility of placing the~     levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery. The~     investigators will gain information about complications at the time of placement; the~     investigators will also examine the expulsion rate, side effects, bleeding patterns and~     subject satisfaction at various time periods after insertion.~   "
172300|NCT01309893|"~     The objective of this study is to determine the clinical feasibility and to evaluate the~     product performance of investigational contact lenses.~   "
172301|NCT01309880|"~     The objective of this study is to determine the clinical feasibility and to evaluate the~     product performance of investigational contact lenses developed by Bausch + Lomb.~   "
172302|NCT01309854|"~     The purpose of this study is to investigate the drug interaction between fostamatinib and~     pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone~     when administered alone and with fostamatinib in healthy subjects.~   "
172303|NCT01309841|"~     The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of~     opioid-induced constipation in patients with non-cancer-related pain, including those~     patients that have inadequate response to laxative therapy (LIR).~   "
172304|NCT01309828|"~     The purpose of this study is to evaluate long term safety and tolerability of azilsartan~     medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and~     hydrochlorothiazide in hypertensive participants with moderate renal impairment.~   "
172305|NCT01309815|"~     The purpose is to describe, interpret and provide a detailed understanding of what it means~     to be elderly people with cancer who receive treatment in specialized health care. Focus is~     especially put on the content and expression of existential issues and the importance of~     spirituality for the patient´s life story and medical story.~   "
172306|NCT01309802|"~     Treating patients with Raynaud's phenomenon who have chronic pain and ulcerations is~     extremely challenging. Published reports and our previous work support our hypothesis that~     symptomatic patients experience relief of pain and healing of ulcerations with minimal~     adverse effects when treated with botulinum toxin type A (Btx-A) injections for Raynaud's~     phenomenon. The proposed study is the first clinical trial and prospective study designed to~     document whether or not 1) Btx-A injection relieves pain in a patient's hand affected with~     Raynaud's disease better than a placebo within 28 days of injection, and 2) Btx-A injection~     relieves pain associated with Raynaud's disease for longer than 28 days, improving patients'~     quality of life. Through this study we intend to further determine the effect of injected~     Btx-A on relieving chronic pain and ulcerations to the ischemic hand while characterizing the~     patients for whom this treatment is most effective.~   "
172307|NCT01309789|"~     The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially~     and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive~     mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is~     a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK,~     immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination~     with multi-agent front-line chemotherapy.~   "
172308|NCT01309776|"~     The primary object of this study is to confirm the superiority of tianeptine compared to~     escitalopram on effects that improves subjective and objective cognitive impairments in~     patients suffering from major depressive disorder.~   "
172738|NCT01304121|"~     This is a randomized clinical trial that will be carried out to examine the use of bioactive~     glass granules (S53P4) as bone graft substitute in filling small and large bone defects as~     compared with autogenous and allogeneic bone grafting, respectively.~   "
172310|NCT01309750|"~     Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in~     patients after recent antibiotic use. The current standard of care treatment for severe C.~     diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is~     unsuccessful, it can lead to need for removal of the entire colon or even death. In fact,~     mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted~     mortality rate is 14% for severe infection. It is believed that the failure of treatment may~     stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral~     vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin~     functions by direct contact with the colon. It is presumed that this paralysis of the small~     intestine is present but has never been proven. The objective of the study is to prove that~     there is an adynamic ileus present in c. diff colitis and therefore lead to investigations~     into improved treatment.~   "
172311|NCT01309737|"~     The main objective of this study is to compare the effects of CP-690,550 with the effects of~     placebo in patients being treated for moderate to severe chronic plaque psoriasis. This~     one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.~   "
172312|NCT01309724|"~     Inadequate identification of and subsequent delayed therapy for patients with hypoperfusion~     (including hypovolemia, congestive heart failure and sepsis) is a common problem faced by~     physicians and intensivists caring for critically ill patients. Bedside clinical assessment~     is notoriously inaccurate in diagnosing complex etiologies of hemodynamic disturbances and in~     deciding on the appropriate therapy. Invasive techniques which are often required to guide~     diagnosis and therapy have significant risks associated with them, are costly, and are time~     consuming. New technology has been developed that allows for instantaneous, noninvasive~     monitoring of key hemodynamic parameters, like stroke volume, peak velocity and cardiac~     output. This new technology has the potential to improve recognition of the etiology of~     hemodynamic disturbances and assist the clinician in optimizing therapy based on changes in~     hemodynamic parameters. There is significant potential for this to be translated into~     improved outcomes in critically ill patients, but this has never been studied.~   "
172313|NCT01309711|"~     N-acetylaspartate (NAA) is a surrogate neuronal marker and its proton magnetic resonance~     spectroscopy (1H MRS) signal decreases with increasing neuronal mortality associated with~     cerebral hypoxia-ischaemia. The MRS lactate (Lac)/NAA peak-area ratio increases during and~     after severe cerebral hypoxia-ischaemia reflecting mitochondrial injury and impaired~     oxidative phosphorylation.~      Aims: (1) To establish normative ranges for thalamic 1H MRS NAA concentration and Lac/NAA in~     healthy newborn infants (2) To examine the accuracies of thalamic 1H MRS NAA concentration~     and Lac/NAA for predicting adverse neurodevelopmental outcome in neonatal encephalopathy (NE)~      Design: Prospective observational study Methods: Year 1: Following 1H MRS methodology~     optimisation 40 healthy control infants will be recruited to collect normative data. Year 2~     to 3: 115 infants with NE, undergoing therapeutic hypothermia will be recruited. MRS will be~     performed aged less than 4 days and 7 to 14 days and thalamic NAA levels and Lac/NAA will be~     quantified; Qualitative interviews to evaluate parental understanding of this biomarker. Year~     4, 5: Outcome assessment by BSID III at 18 months.~      Outcomes: Mean thalamic NAA levels and Lac/NAA and appropriate confidence intervals in normal~     infants, and thalamic NAA levels and Lac/NAA in infants with NE according to~     neurodevelopmental outcome. Areas under curves for thalamic NAA and Lac/NAA will be examined~     separately for early & late MRS. Accuracy of early MRS will inform utility of this~     investigation in decisions about withdrawal of life support; late MRS will inform about~     efficacy as a surrogate end point in clinical trials. Qualitative interviews will be~     thematically analysed and reported.~   "
172314|NCT01309698|"~     This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics~     of vildagliptin in Japanese patients with type 2 diabetes.~   "
172315|NCT01309685|"~     Background:~      - Varenicline (Chantix ) is a drug that is approved by the Food and Drug Administration (FDA)~     to help people stop smoking. Varenicline is very effective in helping some people quit~     smoking, but is less effective for others. Researchers are interested in conducting more~     in-depth studies into how varenicline works, including its effect on smokers' responses to~     items that may trigger cigarette cravings, in order to develop better smoking cessation~     medications.~      Objectives:~      - To examine the effectiveness of varenicline as an effective medication for tobacco~     addiction by studying its effect on nicotine reinforcement, nicotine-seeking behavior,~     cue-elicited craving, and performance impairment and craving after overnight tobacco~     deprivation.~      Eligibility:~      - Individuals between 18 and 50 years of age who have been smoking at least 10 cigarettes per~     day for at least 2 years.~      Design:~        -  This study will require 12 study visits. Some visits will be brief and other visits that~          involve test sessions will last up to 8 hours. If no sessions are repeated, the study~          will take 26 days. Participants will not be required to attempt to quit smoking during~          this study.~        -  Participants will be screened with a full physical examination and medical history,~          blood and urine tests, and other tests as required by the study researchers.~        -  Participants will take two sets of pills during the study: the first set during the~          first 12 days of the study, followed by a 2-day break, then the second set during the~          last 12 days. Some of the pills will contain varenicline, and others will be placebos.~        -  On Day 1 of the study, participants will come to the National Institute on Drug Abuse to~          receive the first set of pills. Participants will take the first pill before leaving.~        -  On Day 8, participants will have a training session that will measure the amount of~          carbon monoxide in the breath. Participants will also complete several questionnaires~          about smoking habits and current mood, and will have a chance to practice the procedures~          they will do in the study.~        -  On Days 9 and 10, participants will have behavioral test sessions that will last 7 to 8~          hours. Day 9 will involve tests of cue response to items that may trigger cigarette~          cravings, and tests of general nicotine cravings over several hours. Day 10 will involve~          tests of general nicotine cravings over several hours, and then tests of~          nicotine-seeking behavior. Participants will be provided with lunch during these all-day~          sessions.~        -  On Day 11, participants will have memory and attention tests, and will provide a blood~          sample. Participants will not be allowed to smoke for 12 hours before the start of the~          next test on Day 12.~        -  On Day 12, participants will provide a breath sample, and will have two sets of memory~          and attention tests before they will be permitted to start smoking again. There will be~          no tests on Days 13 and 14.~        -  Starting on Day 15, participants will repeat the schedule of tests from Days 1 through~          12 with the second set of pills.~   "
172316|NCT01309672|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such~     as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate~     works in treating patients with prostate cancer who have undergone initial hormone therapy.~   "
172317|NCT01309659|"~     The purpose of this study is to determine whether treatment of unexplained anemia in older~     adults with a short course of weekly intravenous iron infusions can improve physical activity~     and therefore quality of life.~   "
172318|NCT01309646|"~     This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine~     when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6~     months of age.~   "
172420|NCT01308294|"~     The purpose of this study is to determine whether vaccination with tumor antigenic peptides~     and both IMP321/LAG-3 and Montanide adjuvants can induce an immune response in melanoma~     patients and to assess the safety and tolerability of this vaccination. Tumor responses~     following this vaccination will also be documented.~   "
172319|NCT01309633|"~     Aims:~      Primary objectives~        -  To determine the pathological complete response (CR)* rate of intermittent sunitinib~          administered with combination cisplatin and gemcitabine as systemic therapy for locally~          advanced or systemic NPC.~        -  To determine the safety and tolerability of intermittent sunitinib administered with~          combination cisplatin and gemcitabine as systemic therapy for locally advanced or~          systemic NPC.~      Secondary objectives~        -  To determine the clinical response rate (RR; complete and partial response)+ of~          intermittent sunitinib administered with combination cisplatin and gemcitabine as~          systemic therapy for locally advanced or systemic NPC.~        -  To evaluate the pharmacodynamic effects (imaging, circulating and tissue) of~          intermittent sunitinib administered with combination cisplatin and gemcitabine as~          systemic therapy for locally advanced or systemic NPC.~        -  To compare the early pharmacodynamic effects (imaging, circulating and tissue) of a~          loading dose of 12.5mg or 25mg sunitinib for 7 prior to administration of systemic~          cisplatin and gemcitabine chemotherapy.~   "
172320|NCT01309620|"~     Zinc supplementation reduces the extent of oxidative damage and improves vascular indices in~     type 2 diabetics~   "
172321|NCT01309607|"~     The purpose of this study is to evaluate the efficacy and safety of weekly paclitaxel and~     carboplatin, in combination with lapatinib, in the neoadjuvant treatment of non-metastatic~     erbB2-positive breast cancer.~      Secondary objectives include:~        -  To determine the safety and tolerability of weekly paclitaxel and carboplatin, combined~          with lapatinib, in an Asian population~        -  To determine breast conservation rates following neoadjuvant paclitaxel/ carboplatin/~          lapatinib~        -  To determine clinical response rates and relapse-free survival of patients treated with~          neoadjuvant paclitaxel/ carboplatin/ lapatinib~        -  To identify predictive tumour biomarkers for pathologic complete response~      The investigators hypothesize that pathologic complete response rates will be improved from~     15% to 35% with the neoadjuvant regimen of carboplatin/ paclitaxel/ lapatinib compared to~     standard chemotherapy alone in HER2 positive early stage breast cancers.~   "
172322|NCT01309594|"~     An international investigation to evaluate if, and if so how long, autologous bone marrow~     hematopoietic stem cell transplantation can safely restore liver functions for HIV infected~     patients who have decompensated liver cirrhosis.~   "
172323|NCT01309581|"~     The primary objectives of this study are to investigate the potential for ketamine anesthesia~     to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease~     acute ECT-induced adverse cognitive effects.~   "
172324|NCT01309568|"~     The objective of this study is to demonstrate the clinical performance of the Quidel Reader~     Influenza A+B test and Quidel Reader with the following sample types: nasal swab,~     nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on~     comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or~     Alternative Laboratory.~   "
172325|NCT01309555|"~     This is an Australian, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth~     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.~   "
172326|NCT01309542|"~     The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR)~     during open-label treatment in adult outpatients who had a primary diagnosis of major~     depressive disorder (MDD). The study also evaluated the long-term response of subjects~     receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and~     absence of depressive symptoms (remission).~   "
172327|NCT01309529|"~     Current standard of practice in study institution dictates day of surgery urinary catheter~     removal in general thoracic surgery patients receiving thoracic epidural analgesia. The~     investigators hypothesize that this practice results in low recatheterization rates secondary~     to urinary retention and low urinary tract infection rates.~   "
172328|NCT01309516|"~     The study aims to:~        1. Develop a culturally appropriate psychosocial intervention~        2. Test feasibility and acceptability of psychosocial intervention in women suffering from~          postnatal depression.~      Primary Hypothesis:~      Depressed mothers who will receive the group intervention will show significant improvements~     in terms of symptoms of depression.~      Design:~      Randomised controlled trial.~      Setting:~      Outpatient department of Civil hospital Karachi.~      Participants:~      A total of 84 depressed mothers will be randomised equally to an intervention group and a~     Treatment as usual control group.~      Interventions:~      The 12 session multimodal psychosocial intervention will be delivered to mothers in the~     intervention group over a three months period. Each session would take up to 45 minutes.~     Control group will receive standard postnatal follow-up.~      Outcome measures:~      Primary outcome measures would be mothers' scores on Edinburgh Postnatal Depression Scale~     (EPDS)and Hamilton Depression Rating Scale (HDRS).~   "
172329|NCT01309503|"~     The main purpose of the study is to estimate speech intelligibility in noise. A Norwegian~     Hearing in Noise Test (HINT) for children will be implemented, and test results for normal~     hearing (NH) children and adults will be collected. Test results for groups of hearing aid~     (HA) users and test results for cochlea implant (CI) users will be collected and compared to~     the NH group and between groups of HA users and CI users. A group of single sided hearing~     loss patients will also be included. Binaural benefits of two ears, two HAs and two CIs will~     be estimated.~   "
172330|NCT01309490|"~     The purpose of this study is to learn whether oral Ribavirin is safe and effective in~     treating patients with solid tumour cancers, that have high levels of the protein eIF4E.~   "
172331|NCT01309477|"~     It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release~     Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).~   "
172332|NCT01309451|"~     The investigators hypothesize that a combination treatment with Avastin and Ozurdex will~     result in a more rapid improvement of visual acuity compared to the use of Avastin alone.~   "
172333|NCT01309438|"~     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of~     rivaroxaban when administered with erythromycin to study participants with mild or moderate~     renal impairment compared to the pharmacokinetics and pharmacodynamics of rivaroxaban~     administered to study participants with normal renal function.~   "
172334|NCT01309425|"~     The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of~     tapentadol (CG5503) in healthy Japanese and Korean adult male participants.~   "
172336|NCT01309399|"~     Teriparatide is a potent osteoporosis medication that helps prevent fractures, however, the~     investigators know little about its effect on the hip. The investigators will evaluate hip~     bone samples from patients treated with teriparatide before undergoing hip replacement. The~     information will help us understand how teriparatide might help reduce hip fracture risk.~   "
172337|NCT01309386|"~     The purpose of this study is to evaluate the conversion rate based on the number of~     participants achieving pain control and safety within 1 week after switching the opioid~     (morphine-like medications) analgesics (drug used to control pain), when tapentadol~     extended-release (ER) (JNS024ER) is orally administered to participants treated with~     around-the-clock opioid analgesics, for their moderate to severe (very serious, life~     threatening) chronic (lasting a long time) malignant (cancerous) tumor-related (a mass in a~     specific area) cancer (abnormal tissue that grows and spreads in the body) pain.~   "
172338|NCT01309373|"~     The purpose of this study is to estimate the level of symptomatic and psychosocial remission~     of patients with schizophrenia and schizoaffective disorder in standard clinical practice as~     a function of the degree of adherence to antipsychotic treatment. The secondary objectives~     are to study the level of community integration of the patients included in the study, and~     its influencing factors, to analyze the role of various sociodemographic factors, factors~     related to the course of disease and the psychopathological status of the patient in~     community integration and remission, to analyze the potential predictors of a favorable~     course (symptomatic and psychosocial remission) and a poor course (no symptomatic or~     psychosocial remission), to assess the impact of treatment adherence on the change in the~     functional and community integration status of patients (based on the occupation,~     independence level, and degree of disability variables), to assess the significance of~     premorbid (academic and social) adjustment in the symptomatic and functional remission and~     the community integration status of patients and to correlate the level of insight to the~     remission and integration status of patients.~   "
172339|NCT01309360|"~     Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary plexus~     anesthesia have any effect on the success rate and additional parameters of block quality?~     Methodology: In this prospective cohort study three groups of 40 outpatients each were~     administered dosages of 1% prilocaine of either 40mL, 30mL or 20mL for axillary plexus~     anesthesia. Met-Hb was measured prior to administration of the block and then hourly until~     the Met-Hb concentration fell. Parameters of block quality and any adverse effects were~     recorded. The level of significance was defined with α ≤ 0.05.~   "
172340|NCT01309347|"~     The purpose of this study is obtain prosthetist's feedback on the novel conformable socket~     material developed by Infoscitex, and determine if it is a viable alternative to current~     prosthetic socket liners. During this task, the research team will travel to the prosthetists~     locations to have them evaluate the socket system by examining the material and providing~     their professional opinions and feedback with regard to comfort and fit for the amputee, its~     ease of use, and breathability.~   "
172341|NCT01309334|"~     Multicenter open-label prospective comparative study of PET-scan and MRI at the time of~     diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.~   "
172342|NCT01309321|"~     The purpose of this study is to determine if an intensive handwashing intervention~     administered to primiparous women during their pregnancy can increase maternal handwashing~     with soap at critical times.~   "
172343|NCT01309308|"~     Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to~     delivery.~   "
172344|NCT01309295|"~     This prospective observational study will assess the efficacy and safety of Mircera (methoxy~     polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney~     disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each~     patient will be collected over 12 months of treatment.~   "
172345|NCT01309282|"~     This observational study will assess the long-term efficacy and safety of MabThera/Rituxan in~     routine clinical practice in patients with sero-positive rheumatoid arthritis who are~     non-responders or intolerant to a single tumour necrosis factor (TNF) inhibitor. Data will be~     collected from each patient over 2 years.~   "
172346|NCT01309269|"~     This observational study will assess the effect of long-term treatment with Mircera (methoxy~     polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data~     will be collected from each patient for at least 24 months.~   "
172347|NCT01309256|"~     Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical~     robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many~     studies have reported successful outcomes for robotic surgery, there is no multicenter~     prospective analysis regarding the advantage of the robotic gastrectomy. The aim of this~     study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the learning~     curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in comparison~     with laparoscopic gastrectomy.~   "
172348|NCT01309243|"~     The purpose of the study was to evaluate the safety and efficacy of the emtricitabine~     (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR)~     compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously~     received treatment with antiretroviral medications.~      Participants were randomized in a 1:1 ratio to receive one of the study treatments.~     Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL)~     at screening. A treatment duration of 96 weeks was planned, with the option for subjects in~     FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is~     commercially available or until Gilead Sciences elects to terminate development in that~     country.~   "
172417|NCT01308333|"~     X-linked hypohidrotic ectodermal dysplasia (XLHED) is a complex genetic disorder~     characterized by lack of sweat, sebaceous, submucous, Meibomian and mammary glands, sparse~     hair and eyebrows, and oligodontia. Insufficient function of the respective glands may lead~     to chronic inflammatory processes in airways and eyes of the affected individuals. The~     investigators will quantify sweat glands of XLHED patients, assess chronic conjunctivitis and~     blepharitis in conjunction with quantitative and/or qualitative alterations of lacrimal fluid~     in these subjects, evaluate lung function and assess chronic inflammatory processes in the~     airways by NO measurements. The data should provide a basis for genotype-phenotype~     correlations.~   "
172349|NCT01309230|"~     This is a Phase II open-label trial of maintenance Vigil™ autologous tumor cell vaccine.~     Tumor will be harvested at the time of surgical debulking (standard of medical care).~     Subsequently, patients achieving clinical CR following primary surgical debulking and doublet~     chemotherapy will be stratified for i) surgical stage (Stage IV or suboptimal debulking (>1~     cm residual) Stage III disease versus Stage III patients with optimal debulking (<1 cm~     residual)) and ii) post-op chemotherapy, pre-vaccine CA-125 >10 ≤ 20 U/mL versus 0≤10 U/ml.~     (Note: patients with Stage IIIc ovarian cancer will be additionally evaluated as a subset~     using descriptive statistics only). Patients will receive 1.0 x 10^7 cells / intradermal~     injection of gene transfected autologous tumor cells, Vigil™ once a month for up to 12 doses~     as long as sufficient material is available. Enough harvested tissue to provide a minimum of~     4 monthly injections will be required for entry into the study. Hematologic function, liver~     enzymes, renal function and electrolytes will be monitored monthly. Immune function analysis~     including ELISPOT analysis of cytotoxic T cell function to autologous tumor antigens will be~     monitored at (≤24 hours before) tissue harvest, ≤24 hours before the first cycle of~     chemotherapy (post debulking), ≤24 hours before the third cycle of chemotherapy (post~     debulking), baseline (screening), prior to Vigil™ injection Months 2, 4, 6 and at EOT. The~     dates of the last dose of chemotherapy and the administration of Vigil™ vaccine #1 will be~     recorded. Treatment will be continued until disease recurrence or exhaustion of the patient's~     vaccine supply. If ≥ Grade 2 toxicity by NCI Common Toxicity Criteria (excluding Grade 2~     fever ≤ 24 hours and Grade 2 and 3 injection site reactions) develops related to study~     treatment the vaccine dose will be reduced by 50% and continued on a monthly basis. If a~     single patient develops ≥ Grade 3 toxicity (other than injection site reaction) related to~     study treatment the trial will be placed on hold for reevaluation of design in discussion~     with FDA. During this hold, no new subjects will initiate dosing, but subjects already being~     dosed may continue dosing as scheduled if deemed clinically appropriate by the PI.~   "
172350|NCT01309217|"~     Nurse-administered smoking cessation interventions have been shown to be efficacious, but are~     seldom implemented due to lack of training and time. This project aims to disseminate and~     test the nurse-administered Tobacco Tactics intervention in 6 hospitals.~   "
172351|NCT01309204|"~     The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine~     fixed combination in lowering intraocular pressure (IOP) relative to each of its individual~     active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with~     open-angle glaucoma or ocular hypertension.~   "
172352|NCT01309191|"~     The purpose of this study is to determine whether Minoxidil treatment affects hair growth in~     patients with male pattern baldness or androgenetic alopecia.~   "
172353|NCT01309178|"~     Cystic fibrosis patients suffer from a chronic destruction of the lung, frequent and finally~     chronic pneumonia and a reduced life expectancy. Unfortunately, no curative treatment for~     cystic fibrosis is available, neither are treatments established that prevent the disease.~     Our data identify ceramide as a potential novel target to treat cystic fibrosis.~      Two smaller trials support the notion that inhibition of the acid sphingomyelinase by~     amitriptyline improves the lung function of CF-patients even at a dose that is low enough to~     avoid adverse effects.~      In the present proposal the investigators, therefore, aim to test in a larger cystic fibrosis~     patient population whether an inhibition of ceramide release in the lung caused by the lack~     of functional CFTR improves the lung function of cystic fibrosis patients. Inhibition of~     ceramide-release in the lung will be achieved by treatment with amitriptyline, which is used~     as an anti-depressant drug for almost 50 years. Although it is not absolutely specific, it~     seems to be relatively specific for the degradation of acid sphingomyelinase (typically~     60-80% of cellular acid sphingomyelinase are degraded), which releases ceramide from~     sphingomyelin.~      If the data confirm the beneficial effect of amitriptyline already observed in our~     preliminary studies, the present clinical study may establish a novel treatment to improve~     clinical symptoms of cystic fibrosis and, moreover, to prevent or at least delay the onset of~     cystic fibrosis.~      Hypothesis~        -  Amitriptyline reduces ceramide concentrations in respiratory epithelial cells (measured~          in nasal epithelial cells obtained by brushing nasal mucosa).~        -  Amitriptyline treatment reduces cell death in bronchi and deposition of DNA on the~          respiratory epithelium, which permits elimination of P. aeruginosa from the lung~          (measured as P. aeruginosa counts in tracheal fluid).~        -  Amitriptyline treatment results in normalization of the function of leukocytes (number~          determined in serum and tracheal fluid)~        -  Amitriptyline reduces systemic and local inflammation (measured as cytokines in plasma~          and tracheal fluid).~      Based on these effects amitriptyline increases the lung function of cystic fibrosis patients~     (measured by FEV1).~   "
172354|NCT01309165|"~     Novel stroke rehabilitation approaches, such as task-specific training (TST), have shown~     promise in improving stroke recovery components such as basic mobility and activities of~     daily living; however, evidence suggests these improvements are not generalized and~     transferred to home, community, or work settings, and usually do not impact overall~     participation outcomes. Further, these treatments are very intense, with total treatment~     times as high as 30 to 60 hours, making them clinically or economically unfeasible in many~     settings. In contrast, approaches incorporating cognitive strategy training have shown great~     promise to not only improve functional activity performance in people living with stroke, but~     also to facilitate generalization and transfer beyond the clinical setting, and to do so in~     10 to 15 treatment hours. Cognitive Orientation to daily Occupational Performance (CO-OP) is~     an established treatment approach that uses cognitive strategies in combination with TST.~     Evidence from other research groups and findings from our own participant interview data~     indicate that the approach may be even more effective if introduced much earlier in the~     rehabilitation process, however, CO-OP has not yet been tested in this sub-acute population.~     Therefore, the specific project goals are: 1. To refine the CO-OP treatment approach for use~     with people less than three months post stroke; 2. To evaluate, in a Phase II clinical trial,~     the preliminary efficacy of the refined protocol compared to standard occupational therapy on~     immediate and longer-term skill performance and participation; 3. To determine effect sizes~     for power calculations for a future Phase III clinical trial to test the new protocol versus~     contemporary treatment. The research approach consists of Part 1, Protocol Refinement, and~     Part 2, Exploratory Phase II Clinical Trial.~   "
172355|NCT01309152|"~     The investigators hypothesize that cefazolin perfusion to subcutaneous adipose tissue is~     reduced in morbidly obese patients. The primary objective of this exploratory pilot study is~     therefore to investigate target site (subcutaneous adipose tissue) penetration of cefazolin~     in morbidly obese patients and non-obese patients. The investigators aim to examine whether~     and how cefazolin plasma concentrations are predictive of subcutaneous (target) cefazolin~     concentrations. Possible factors of influence on the distribution of cefazolin (tissue~     perfusion, body weight, distribution of adipose tissue, other) will be identified.~   "
172356|NCT01309139|"~     The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after~     treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of~     tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the~     systemic exposure following inhalation of the free combination (Treatment B) of tiotropium~     (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered~     once-daily over 21 days via Respimat(R) (RMT).~      The secondary objectives are:~      to compare the systemic exposure to tiotropium and CD 1857 after single dose administration~     of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to~     BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the~     free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium~     and BI 54903 when administered as FDC and as free dose combination, respectively~   "
172357|NCT01309126|"~     Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified~     subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to~     treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed~     until progression or discontinuation for some other reason. Efficacy will be assessed via~     Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans~     will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and~     biomarker parameters will also be assessed.~   "
172358|NCT01309113|"~     Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180~     patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to~     achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are~     expected to complete the study per protocol.~      Study objectives:~      Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for~     treatment of cyclic mastodynia and premenstrual syndrome.~      To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic~     mastodynia.~      Dose regimen:~      Group 1: VAC BNO 1095 1x10 mg:~      1 tablet of verum in the morning, 1 placebo tablet in the evening~      Group 2: VAC BNO 1095 2x10 mg:~      1 tablet of verum in the morning, 1 tablet of verum in the evening~      Group 3: Placebo:~      1 tablet placebo in the morning, 1 tablet placebo in the evening~      The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first~     screening further visits are scheduled after the end of each of the first and second run-in~     cycle, and after the first, second and third treatment cycle, respectively.~      Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of~     menstruation number n, with exception of the first screening visit which can be performed at~     any time prior to the first run-in cycle. Subsequently the time between the first study visit~     and the onset of the first run-in cycle menses T shall be added to the overall study~     duration.~      In case that the next menstruation does not commence as expected, the patient should contact~     her investigator immediately in order to schedule a new appointment, approximately on the~     actual day 3 of the menses.~   "
172359|NCT01309100|"~     The objective of this study is to determine the clinical feasibility and to evaluate the~     product performance of investigational contact lens.~   "
172360|NCT01309087|"~     The primary objective of this study is to substantiate prediction accuracy(with a tighter 95%~     confidence interval compared to current diagnostic modalities), of a lung cancer biomarker~     for risk stratification of patients into high and low risk categories to aid in clinical~     evaluation of the patient.~   "
172361|NCT01309074|"~     The aim of the study is to compare the safety & efficacy of sertraline (up to a dose of~     200mg/day) & pregabalin (up to a dose of 300mg/day)for the treatment of symptoms of anxiety~     in patients with epilepsy.~   "
172362|NCT01309061|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of adipose tissue derived mesenchymal stem cells (MSCs) in patient with~     progressive hemifacial atrophy.~   "
172363|NCT01309048|"~     This study is to confirm the safety and technical of MRI guided High Intensity Focused~     Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases.~      MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate~     tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue.~     The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be~     performed in patients who pass inclusion/exclusion criteria.~   "
172364|NCT01309035|"~     Introduction:~      Approximately 7000 total knee replacements (TKAs) are done every year. More than 90% of these~     knee replacements are performed with the use of bone cement. Traditionally, a tourniquet has~     been, used to reduce the bleeding during surgery, enabling surgeons to perform delicate~     dissections in a bloodless operative field.~      A tourniquet can be defined as a constricting or compressing device used to control~     temporarily venous and arterial circulation to an extremity. Pressure is applied~     circumferentially on the skin and underlying tissues of a limb. This pressure is transferred~     to the walls of vessels, causing them to become occluded.~      It is well known that applying a tourniquet for more than 1 to 2 hours is associated with a~     number of disadvantages, for instance, severe pain and muscle effects during the first~     postoperative day, thereby slowing rehabilitation.~      Other side effects related to tourniquet use, include pulmonary embolus caused by venous~     thrombosis and arterial thrombosis as a result of the dislodgement of an arterial plaque.~     Furthermore, tourniquet-induced hypertension with general anaesthesia, muscle injury, a wide~     spectrum of neurologic injuries, and tissue changes (Oedema compartment syndrome,~     post-tourniquet syndrome) have been reported. An important fact is that bleeding affects the~     quality of binding between bone and cement and thereby fixation of the knee prosthesis? Since~     the introduction of modern cementing techniques, no previous clinical studies have~     investigated the advantages or disadvantages of tourniquet use in knee replacement surgery.~      Aims/hypothesis of the study:~        1. To investigate the advantages and disadvantages of tourniquet use, including whether not~          using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens~          length of stay.~        2. To study whether use of a tourniquet affects leg muscles during and after surgery, as~          measured by with use of microdialysis to quantify level of ischemia .~        3. To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet~          use. Because third generation cements secure prosthesis fixation, the investigators do~          not expect to find any clinically significant migration (less than 2 mm) 2 years after~          surgery.~      Perspectives:~      The investigators hope that the results of our study will improve rehabilitation regimes so~     that patients will experience less pain after surgery and thus achieve more rapid~     mobilisation and return to their daily lives.~   "
172365|NCT01309022|"~     The purpose of this protocol is to provide continued acess to immunosuppressive medications~     to subjects from the completed/closed trial ITN005CT (NIS01,NCT00014911). THIS PROTOCOL DOES~     NOT PROVIDE MEDICINES TO DIABETES PATIENTS WHO DID NOT PARTICIPATE IN ITN005CT.~   "
172366|NCT01309009|"~     This phase IIa study is designed as a multi-centre, single country, randomised, double-blind,~     placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and~     safety of Nepadutant given at two oral doses once daily for seven days in comparison to~     placebo in the treatment of infantile colic.~   "
172367|NCT01308996|"~     The purpose of this study is to evaluate the INFUSE® Bone Graft as an alternative to~     autograft for bone formation in the back of the mandible (lower jaw) prior to placing dental~     implants.~   "
172368|NCT01308983|"~     Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of~     young adults with prehypertension.~   "
172369|NCT01308970|"~     The purpose of this study is to determine if participation in one of three different health~     management groups will elicit genomic and biochemical changes and decrease perceived stress~     levels and symptoms in healthy, stressed adults. The investigators expect that changes in~     self-reported psychological stress and symptoms will be directly linked to changes in~     biological indicators (genomic expression profiles and neuroendocrine and pro-inflammatory~     biomarkers).~   "
172370|NCT01308957|"~     The purpose of this study is to examine the effect of omega-3 fatty acid supplementation on~     changes in muscle mass, muscular strength and physical function.~   "
172418|NCT01308320|"~     Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general~     anaesthesia through binding to its receptors in the brainstem. However, it has not been~     proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during~     emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the~     relationship between fentanyl doses and cough suppression during emergence from sevoflurane~     anaesthesia.~   "
172371|NCT01308944|"~     This research is looking at the effect of biobehavioral factors such as stress and whether~     these factors alter how the body responds to chemotherapy, one of the purposes of this study~     is to determine if the addition of a beta-blocker such as Propranolol (Inderal) is tolerable~     when given with chemotherapy in the treatment of newly diagnosed ovarian, fallopian tube, or~     primary peritoneal cancer. An additional purpose of the study is to understand if behavioral~     factors such as depression and anxiety can alter different blood markers that affect tumor~     vascularity. The Investigator wishes to determine whether the use of beta-blocker drugs such~     as Inderal, might alter these behavioral factors by drawing blood prior to and after the~     administration of Inderal as well as giving behavioral questionaires at different time~     points. Beta-blockers are commonly used for the treatment of hypertension, protection of the~     heart after a heart attack, and irregularities in heartbeats. Altering these factors might~     boost the immune system and affect other areas of cancer biology, thereby allowing the~     chemotherapy to be more effective. The significance of this research is that it may help~     improve our treatments of this disease in the future.~   "
172372|NCT01308931|"~     Anti-mullerian hormone (AMH) has been shown to be a reliable marker of ovarian reserve. In~     prior studies, tubal ligation has been shown to have an adverse effect on ovarian reserve.~     One theory postulated for this effect is that the ovarian circulation is disrupted by the~     procedure, leading to altered hormone production. In this prospective cohort study, the~     investigators plan to analyze the rates of AMH decline by comparing the following~     contraceptive methods: tubal ligation, Essure placement, and levonorgestrel intrauterine~     devices (IUDs).~   "
172373|NCT01308918|"~     Thoracic surgeries usually require lung isolation techniques. Double-lumen tube (DLT), either~     right or left sided, is the most frequent tool used to realize this technique. In front of~     difficult airways, the use of videolaryngoscopy (GllideScope®) (GS) may advantageous.~     Hypothesis: We will test the hypothesis that under GS, the use of a specific semi-rigid~     stylet is efficacious to insert a DLT, and also safe. The increased rigidity of the GlideRite~     DLT Stylet for double-lumen tubes will enable the DLT to keep its form while it is railroaded~     into superior airways. This new stylet combined to Glidescope® utilization will increase the~     rate of successful intubation, especially in patients with difficult airways. This technique~     will allow us to directly intubate with a DLT using the GlideScope®, avoiding a beforehand~     SLT intubation and airway exchange catheter use. Consequently, its use could reduce risks~     associated to blind insertion of DLT with airway exchange catheter (airway traumatism and~     pulmonary aspiration). Primary objective: To determine the GlideRite DLT Stylet efficiency~     for double-lumen tubes orotracheal intubation under videolaryngoscopy (GllideScope®).~     Secondary objectives: to time successful intubation, to count the number of intubation~     attempt, to verify the influence of difficult intubation score (DIS) on successful~     intubation, and to log complications associated to its use. Exclusion criterion are: previous~     history of difficult intubation, anticipated difficult mask ventilation, and anticipated~     difficult intubation. Conclusion: The aim of using the GlideRite DLT Stylet for an~     orotracheal intubation under videolaryngoscopy is to allow the primary intubation with a DLT~     in patients with abnormal superior airways. These anomalies are more and more frequent.~     Alternative airway management implies more manipulations, leading to an increased risk of~     oxygen desaturation, lung aspiration, and airway lesions. Moreover, these alternatives take~     more time than using a Glidescope, which can be compare to direct laryngoscopy. The~     development of a semi-rigid stylet, such as the GlideRite DLT Stylet, is a great advancement~     in the management of primary intubation with DLT, mainly in face of difficult airways.~   "
172374|NCT01308905|"~     The purpose of this study is to gain knowledge about how to best diagnose and treat tumors,~     how tumors affect normal tissue and how treatment of tumors with radiation therapy and~     chemotherapy affect tumors.~   "
172375|NCT01308892|"~     In the CHOC study the investigators will examine the effect of chocolate flavanols on~     vascular function, inflammation, oxidative stress and markers of endothelial function. The~     effects of both acute consumption and prolonged consumption will be studied. The secondary~     objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve~     the response to a high fat/high energy challenge.~   "
172376|NCT01308879|"~     The purpose of this clinical trial was to test the hypothesis that clients of clinicians who~     were scheduled to receive weekly feedback on their clients' progress would improve faster~     than clients of clinicians who were not scheduled to receive weekly feedback.~   "
172377|NCT01308866|"~     BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging~     lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic~     patient involvement in the preventive decision with the help of a decision aid has an impact~     on cardiovascular (CV) risk reduction superior to usual care.~      METHOD: The design is a cluster randomised clinical trial. Participants are~     hypercholesterolemic patients (>200 mg/dl or c-LDL>130) from four primary care teams of~     Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are~     excluded. It is expected to create two cohorts of 139 patients each one. The randomisation is~     by doctor. Intervention group will receive information about their CV risk and the risk and~     benefits of different preventive measures. They will have access to a decission aid that will~     help them in the choice of the preventive measures.The material (printed and software) is~     adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE and~     DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors, subjective~     health (SF 12), decisional conflict, anxiety/depression, analytic controls, treatment,~     treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12 month~     assessment. The study, financed by FIS, will begin the 01-07-2007.~      RESULTS: The expected results are a higher reduction on the CV risk factors in the~     intervention group versus regular care.~      CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.~   "
172378|NCT01308853|"~     The study evaluates treatment procedure, efficacy and safety of NASHA BE for female breast~     enhancement.~   "
172379|NCT01308840|"~     The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in~     KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have~     previously not received chemotherapy. This study will also examine the potential toxicities,~     progression-free and overall survival in this population.~   "
172419|NCT01308307|"~     Purpose: : This study was performed to compare the accuracy of non-cycloplegic~     photorefraction with cycloplegic refraction in detection of refractive amblyopia risk factors~     and determine some corresponding beneficial cut points.~      Method: In this diagnostic accuracy study, right eyes of 185 children (1 to 14 years)~     underwent first non-cycloplegic photorefraction (with PlusOptix SO4 photoscreener) and then~     cycloplegic refraction from October 2009 to August 2010. Based on the cycloplegic refraction~     results, hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D)~     were set as criteria based on AAPOS guidelines. The difference in detection of refractive~     amblyopia risk factors between the two methods was the main outcome measure.~   "
176691|NCT01252420|"~     The purpose of this study is to determine whether a limited duration of treatment (two weeks~     of low molecular weight treatment) is a safe and effective treatment for distal deep vein~     thrombosis of the lower limb.~   "
172380|NCT01308827|"~     Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia and pneumococcal~     meningitis among infants and children worldwide. Knowledge of the epidemiology of~     pneumococcal disease is essential to assess the potential usefulness of pneumococcal disease~     usefulness of pneumococcal conjugate immunization. There is a paucity of information~     regarding pneumococcal disease burden in children in Latin America. Most studies are based on~     passive microbiology laboratory surveillance that does not capture all invasive disease, thus~     underestimating the true disease burden. Data from an active surveillance is available from~     an specific region in Costa Rica, before introduction of universal vaccination with PCV-7. On~     January 2009, PCV-7 was introduce into the universal vaccination program for all children~     born after or on September 2008 using a 3+1 regimen therefore there is a possibility to~     analyze the benefits of the introduction of this vaccine into the universal immunization~     program. The only effectiveness data from Latin America have been published from Uruguay~     where a significant decline in the incidence of pneumonias and meningitis was observed~     following the introduction of PCV-7. This was associated with an increment of serotypes 19A,~     1,5 and 7F. Uruguay modify PCV-7 to PCV-13. In Costa Rica on August 2011, PCV-7 was changed~     for PCV 13. This study will provide information regarding the impact of PCV-7 and PCV-13.~   "
172381|NCT01308814|"~     Study Background and Objectives: In the U.S. the majority of heart disease deaths are in~     women, not men. Much of the gender disparity in CVD rates relate to the burden of CV risk in~     women after the menopause. Depression has been associated with an increased risk for CVD~     morbidity and mortality. Even histories of recurrent depression in euthymic individuals are~     associated with elevated CV risk. Understanding the depression-CVD link may have particular~     relevance for women since women experience depression at a rate twice that of men.~     Substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one~     likely mechanism contributing to both CVD and depression in women. The perimenopause, a time~     associated with a two-fold increase in rates of depression, may provide an ideal opportunity~     for studying the pathophysiology of CV risk and depression in women.~      The primary objective of this study is to examine the prophylactic role of estradiol in the~     development of depressive symptoms and the progression of cardiovascular risk in~     perimenopausal women with or without histories of depression. The investigators predict that~     women susceptible to depression will be particularly vulnerable to the acceleration of CVD in~     the context of the perimenopause and, consequently, will show differentially greater benefit~     of estradiol treatment during the menopause transition for both indices of CV risk (e.g.~     inflammation, endothelial function, stress reactivity), as well as depressive symptoms.~   "
172382|NCT01308801|"~     The purpose of this study is to determine the analgesic effectiveness of Repetitive~     Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation~     exercises in patient suffering from fibromyalgia.~      A double blind clinical trial with two randomized parallel groups:~        -  Placebo rTMS and rehabilitation exercise~        -  Active rTMS and rehabilitation exercise~   "
172383|NCT01308788|"~     The purpose of this study will be to compare the aqueous production suppressant to aqueous~     outflow drugs in terms of the response to known vascular parameters. Specifically; systemic~     perfusion pressure, retrobulbar blood flow and retinal microcirculation.~   "
172384|NCT01308775|"~     This is a pilot study that will compare two systems of breast cancer follow up care and will~     evaluate a number of parameters indicating quality and efficiency of care delivery as well as~     patient satisfaction with care. Approximately 100 breast cancer patients who have completed~     the acute phase of treatment will be randomized to one of two follow up care plans.~   "
172385|NCT01308762|"~     To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed~     Mycobacterium obuense) in melanoma cancer patients.~   "
172386|NCT01308749|"~     The investigators propose to conduct this pilot study to evaluate oxytocin as a supplemental~     treatment for improving social difficulties in individuals with autism.~   "
172387|NCT01308736|"~     The investigators will randomize smokers to receive 1) Varenicline + smoking~     cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling.~     Neither the participants nor the research therapists/evaluators will know to which condition~     (active or placebo pill) the participants have been assigned i.e., a double-blind study). The~     medication and weekly counseling will occur for 28 days. Participants will complete~     assessment measures just before the start of treatment (baseline), at the end-of-treatment,~     at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use~     between treatment groups.~   "
172388|NCT01308723|"~     This open-label study will assess the safety, efficacy and pharmacokinetics of RO5323441 in~     combination with sorafenib in patients with advanced or metastatic hepatocellular carcinoma~     previously untreated with systemic therapy. In the dose-finding Part I, cohorts of patients~     will receive escalating doses of RO5323441 intravenously (iv) every 2 weeks in combination~     with sorafenib 400 mg orally twice daily. In the exploratory Part II, patients will be~     randomized to receive either the previously established dose of RO5323441 iv every 2 weeks~     plus continuous oral sorafenib or sorafenib alone. Anticipated time on study treatment is~     until disease progression or unacceptable toxicity occurs. For patients in the sorafenib arm~     with disease progression crossover to combination treatment with RO5323441 will be allowed.~   "
172399|NCT01308580|"~     Primary Objective:~      - To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m²~     (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants~     with metastatic castration resistant prostate cancer (mCRPC) previously treated with a~     docetaxel-containing regimen.~      Secondary Objectives:~        -  To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was~          better tolerated than Cabazitaxel 25 mg/m².~        -  To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:~             -  Progression Free Survival (PFS) defined as the first occurrence of any of the~               following events: tumor progression per Response Evaluation Criteria In Solid~               Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or~               death due to any cause;~             -  PSA Progression;~             -  Pain progression;~             -  Tumor response in participants with measurable disease (RECIST 1.1);~             -  PSA response;~             -  Pain response in participants with stable pain at baseline.~        -  To compare Health-related Quality of Life (HRQoL).~        -  To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.~   "
172389|NCT01308710|"~     Children with high cholesterol levels are especially vulnerable and are at high risk for~     early onset coronary heart disease (CHD). Endothelial dysfunction, the earliest phase of CHD,~     is present in children with elevated cholesterol levels as early as 8 years of age. The long~     term objective of this study is to develop dietary interventions for the prevention and~     treatment of endothelial dysfunction in children with common lipid disorders including~     familial hypercholesterolemia (FH) and familial combined hyperlipidemia (FCH). Increasing~     evidence suggests that the Mediterranean diet and ω-3 fatty acids found in fish have~     cardioprotective effects. The specific aims of the study are to: determine whether a~     Mediterranean diet alone or combined with ω-3 fatty acid (eicosapentaenoic acid)improves~     endothelial function; evaluate the effects of the dietary interventions on lipids and~     lipoprotein subclasses; evaluate the effects of the dietary interventions on biomarkers for~     oxidative stress and inflammation. This study is a randomized, double-blind,~     placebo-controlled clinical trial that includes 34 children (ages 8-17) treated with the~     Mediterranean diet and ω-3 fatty acid supplements. A dietary educational behavioral~     intervention will be conducted over 6 months with individual counseling and group sessions.~     Endothelial function will be measured noninvasively by high resolution ultrasound of the~     brachial artery at baseline, 6, 12, 18 and 24 weeks. This study is unique because it is a new~     intervention designed for children at high risk for early CHD with a dietary component and~     supplementation with ω-3 fatty acids. If effective, this intervention would be broadly~     applicable in the community and lend valuable insight about dietary therapy to prevent the~     progression of CHD in hyperlipidemic children.~   "
172390|NCT01308697|"~     Flail chest refers to a section of the rib cage that has broken away from the surrounding~     ribs. Usually, more than one rib is involved, and they are broken in at least two places.~     Flail chest typically is the result of blunt chest trauma. As a result of flail chest, the~     chest wall becomes unstable and dangers of life threatening respiratory failure and hypoxemia~     (lack of oxygen to circulating blood which will lead to organ damage or failure)occur.~      Currently, these injuries are treated non operatively. However, small case series have~     demonstrated that operative management can improve Intensive Care Unit (ICU) length of stay,~     improved pulmonary function and decreased pain leading to decreased duration of mechanical~     ventilation, and the incidence of complications related to this injury.~      This study hopes to provide information on whether a prospective randomized trial is feasible~     by first undertaking a small pilot study to determine rate of recruitment, data collection~     methods, and integrity of study protocol.~      Null Hypothesis 1: Enrollment of subjects with flail chest rib fractures into a prospective~     multi-centre RCT is not feasible and a larger clinical trial is unlikely to be completed.~   "
172391|NCT01308684|"~     This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in~     combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the~     dose-finding part, patients will receive intravenous escalating doses of RO5323441 in~     combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part,~     patients will be randomized to receive the established dose (from the dose-finding part) of~     RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue~     treatment with RO5323441 and Avastin on the study until evidence of progressive disease or~     unacceptable adverse events happen. In the efficacy-finding part, patients will receive study~     treatment until disease progression or death.~   "
172392|NCT01308671|"~     The purpose of this study is to investigate the effects of steady-state varenicline on the~     antiplatelet action of clopidogrel in patients with coronary artery disease.~   "
172393|NCT01308658|"~     In this study participants will be given 800 mg darunavir, either as one 800-mg tablet~     formulation (G002), or as two commercially available 400-mg tablets formulation (F030), to~     evaluate the effect between both, in the presence of low-dose ritonavir under fasted and fed~     conditions.~   "
172394|NCT01308645|"~     The purpose of this study is to determine efficacy of SB injection in Hepatocellular~     Carcinoma (HCC).~   "
172395|NCT01308632|"~     Indication:~      Subjects with glioblastoma at first relapse after surgery, radiotherapy and first-line~     temozolomide (TMZ).~      Objectives:~        1. Phase I endpoint:~           - To determine the maximum tolerated dose (MTD) of CPT-11 administered on days 8 and 22~          in combination with a fixed, continuous, and metronomic regimen of TMZ, given in 28-day~          cycles.~        2. Phase II endpoints:~      Primary endpoint: Progression-free survival at 6 months. Secondary endpoints: Response rate,~     toxicity profile, overall survival.~      Complementary studies:~      To assess the effect of treatment on plasma concentration of thrombospondin-1 (TSP1), soluble~     VEGF receptor 1 (sVEGF-1) and VEGF-A, and their correlation with clinical outcome.~        -  To assess the correlation between immunohistochemical expression of PTEN and MGMT~          proteins, and clinical outcomes.~   "
172396|NCT01308619|"~     The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg~     immediate release and 10 mg delayed release beads) capsules (Oracea®) as compared to placebo~     in the skin of adults with papulopustular rosacea and to identify a correlation, if any, with~     rosacea-related inflammatory markers.~   "
172397|NCT01308606|"~     The purpose of this study is to compare absorption of TMC435 formulated as 2 different types~     of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when~     taken under fasting conditions or together with a standard or a high-fat meal. This will be~     done in healthy volunteers.~   "
172398|NCT01308593|"~     Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated~     by patient satisfaction~   "
172415|NCT01308359|"~     The purpose of this study is to investigate the hypothesis that glucose administration~     increases fetal movement perception by the pregnant woman.~   "
172416|NCT01308346|"~     The target enrollment goal for the trial was to enroll 36 subjects. However due to a~     challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the~     trial was initiated in June 2011.~      To evaluate the following in participants undergoing coronary artery scaffolding/stenting for~     significant coronary artery disease:~        -  The acute (post-implantation) effect of an implanted bioresorbable vascular scaffold~          (BVS) or metallic drug eluting stent (mDES) on coronary blood flow and physiological~          responsiveness of the target coronary artery~        -  The long-term (2 years) effect of an implanted BVS or mDES on coronary blood flow and~          physiological responsiveness of the target coronary artery~   "
172400|NCT01308567|"~     Primary Objective:~        -  To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20~          mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS)~          in participants with metastatic castration resistant prostate cancer (mCRPC) and not~          previously treated with chemotherapy.~      Secondary Objectives:~        -  To evaluate safety in the 3 treatment arms.~        -  To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for:~             -  Progression Free Survival (PFS) (RECIST 1.1)~             -  Tumor progression free survival (RECIST 1.1)~             -  Tumor response in participants with measurable disease (RECIST 1.1),~             -  PSA response~             -  PSA-Progression free survival (PSA-PFS).~             -  Pain response in participants with stable pain at baseline~             -  Pain progression free survival~             -  Time to occurrence of any skeletal related events (SRE)~        -  To compare Health-Related Quality of Life (HRQL).~        -  To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.~   "
172401|NCT01308554|"~     The purpose of this study is to determine whether injection of bupivacaine into the TAP is~     effective in the treatment of post operative pain after laparoscopic gastric bypass~   "
172402|NCT01308541|"~     The purpose of this study is to explore the pharmacokinetics (PK) and pharmacodynamics (PD)~     of LUSEDRA® administered as a continuous infusion or bolus compared with continuous infusion~     of propofol injectable emulsion.~   "
172403|NCT01308528|"~     The purpose of this study is to compare the safety and security and efficacy of sodium~     enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane~     (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop~     Thromboembolic Disease Undergoing Geral Abdominal Surgery.~   "
172404|NCT01308515|"~     The purpose of this study is to compare the performance of two FDA-cleared tibial bearings~     (replacement for cartilage in the knee) by collecting data on patients through 3 years of~     follow-up.~   "
172405|NCT01308502|"~     The purpose of this study is to evaluate the utility of a minimally invasive nasopharyngeal~     pH probe for the diagnosis of laryngopharyngeal reflux (LPR) in children with airway~     compromise; to determine whether it is comparable to the gold standard esophageal pH probe in~     identifying LPR in this population; and to correlate results of pH testing with validated~     questionnaires. Our hypothesis is that a nasopharyngeal pH probe is equivalent to an~     esophageal probe in identifying laryngopharyngeal reflux.~   "
172406|NCT01308489|"~     This randomized clinical trial studies minimally invasive surgery in treating patients with~     spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor~     resection are less invasive types of surgery for spinal tumors and may have fewer side~     effects and improve recovery~   "
172407|NCT01308476|"~     6 months open label non-interventional observational study acc to § 4, section 23 and § 67,~     section 6 German Medicines Act with two parallel groups~        1. the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram~        2. the control group not receiving a daily SMS reminder~   "
172408|NCT01308463|"~     The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented~     at the two year or next scheduled follow-up period for the early-enrolled patients.~   "
172409|NCT01308450|"~     This study is being conducted to enhance and extend the clinical utility of the Quotient®~     ADHD System Adolescent and Adult Version Test by adding large numbers of well-screened~     controls to the existing Quotient® ADHD System database of adolescents and adults (ages~     15-55).~   "
172410|NCT01308437|"~     This is an open label, randomized, parallel group comparison of the immunogenicity safety of~     Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based~     human insulin products (marketed in USA) in type 1 diabetics.~      There are two phases of the study, which are as follows:~        1. Phase 1 is a comparative phase in which there will be 2 arms (which are described in the~          section below).~        2. Phase 2 is a follow up phase only applicable to Wosulin Arm.~      The study will last for 54 weeks for the patients enrolled in Wosulin arm and approximately~     28 weeks for the patients enrolled in the comparator arm.~      Two hundred and forty two patients will be enrolled considering an estimated dropout rate of~     15% for a sample size of approximately 105 evaluable patients per arm. The total planned~     enrollment period for this study is approximately 3 months (90 days).~   "
172411|NCT01308424|"~     The purpose of this study is to determine if a new treatment is effective for the treatment~     of recurrent symptomatic oral herpes virus infections.~   "
172412|NCT01308411|"~     Asthma affects 6% of the UK population and costs the NHS 1 billion pounds per year. £473~     million alone is spent on inhaled steroid treatment which is designed to reduce inflammation~     in the breathing tubes.~      Unfortunately knowing whether a patient is on just the right amount of steroid treatment is~     difficult, as asthma is a variable disease and the measures currently used to decide on~     increasing or decreasing steroid treatment bare little resemblance to the actual amount of~     inflammation present. Doctors may not reduce treatment as swiftly as necessary if a patient's~     asthma is well controlled because of concern over asthma attacks; this can result in~     potential over treatment with inhaled steroids. Although steroid treatment is safe, side~     effects can occur, and costs are large, so a strategy helping avoid over treatment would be~     beneficial both to patients and to the NHS.~      As the investigators can more accurately measure airway inflammation present in the breathing~     tubes, using a chemical called nitric oxide present in a patient's breath, the investigators~     might be able to more accurately predict which patients could safely reduce their steroid~     treatment. Measuring nitric oxide is simple, and involves breathing into a special machine~     (similar to a roadside breathalyser). In this study the investigators will measure nitric~     oxide in patients with well controlled asthma, and reduce their asthma treatment by 50%. The~     investigators will then follow up the patients and remeasure their nitric oxide. At the end~     of the study the investigators will see if measurements of nitric oxide predicted which~     patients could safely step down their treatment. If successful this could help reduce the~     overall cost to the NHS of inhaled steroids and reduce steroid associated side effects.~   "
172413|NCT01308385|"~     Despite enormous progress insufficient postoperative pain management remains a frequent~     problem in the early postoperative phase after surgery. Furthermore, the pain that persists~     after healing of the surgical wound is a large, but often unrecognized, clinical problem and~     it is estimated that 5-10% of those undergoing surgery will develop severe persistent pain~     leading to chronic disability and psychosocial distress.~      Conditioned Pain Modulation (CPM), also known as the phenomenon pain-inhibits-pain, is a~     reduction in pain somewhere on the body in response to the application of a second painful~     stimulus outside the painful area. In recent years, the CPM has been identified as a~     psycho-physical measure with clinical relevance in characterizing the individual's ability to~     modulate pain and consequently the individual's disposition to acquire painful conditions.~      The purpose of this study is primarily to assess the relationship between CPM efficacy and~     clinical postoperative pain (postoperative pain intensity, use of analgesics, the intensity~     of secondary hyperalgesia and allodynia, and the incidence of persistent postoperative pain)~     associated with minimally invasive repair of pectus excavatum. In addition, the study aims at~     identifying other patient- and/or surgery-related factors affecting the course of~     postoperative pain.~      Hypothesis:~      - The greater the positive difference between the experimental pressure pain threshold (kPa)~     measured before and after application of a second painful stimulus (Cold Pressor Test), the~     lower the risk of developing persistent postoperative pain.~      Secondary hypotheses~        -  The greater the positive difference between the experimental pressure pain threshold~          (kPa) measured before and after application of a different experimental painful stimulus~          (Cold Pressor Test) lower the pain intensity in the early postoperative period.~        -  The greater the positive difference between the experimental pressure pain threshold~          (kPa) measured before and after application of a different experimental painful stimulus~          (Cold Pressor Test), the shorter duration of early postoperative pain.~        -  The greater the positive difference between the experimental pressure pain threshold~          (kPa) measured before and after application of a different experimental painful stimulus~          (Cold Pressor Test), the lower the usage of epidural analgesia (mg / ml).~        -  The larger the positive difference between the experimental pressure pain threshold~          (kPa) measured before and after application of a different experimental painful stimulus~          (Cold Pressor Test) the lower consumption of oral analgesics (mg / day).~        -  Severe acute pain in the early postoperative period (postoperative days 0-3) is~          positively associated with the development of persistent postoperative pain (6 months~          postoperatively).~        -  Presence of preoperative pain and / or high postoperative use of analgesics and / or~          high pain intensity during the first 6-8 weeks postoperatively predicts pain 6 months~          postoperatively.~        -  The higher pain intensity and discomfort associated with brush-evoked allodynia and / or~          pinprick (Von Frey) secondary hyperalgesia the greater the risk for developing~          persistent postoperative pain (6 months postoperatively).~        -  High levels of preoperative catastrophizing (assessed on the day of admission) is~          related to the severity of acute pain (rated third postoperative day) and chronic pain~          (assessed 6 months postoperatively), even if controlled for depression and anxiety.~        -  The degree of preoperative positive and negative emotions (as assessed on the day of~          admission) is related to the degree of acute pain (rated third postoperative day) and~          chronic pain (assessed 6 months postoperatively) so that negative emotions are~          associated with high levels of pain, while positive feelings are related to low levels~          of pain.~        -  The study population does not differ significantly from the normal population in terms~          of personality traits (emotional reactions, extraversion, openness to experience,~          friendliness, conscientiousness).~        -  The study population does not experience a significant change in personality traits~          during the first 6 months after surgery.~        -  The quality of life and self-esteem is lower among patients who develop persistent~          postoperative pain compared with pain patients.~        -  Quality of life and self-esteem improve as a result of minimally invasive repair of~          pectus excavatum.~   "
172414|NCT01308372|"~     The purpose of this study is to evaluate the proportion of patients which present a high~     cardiovascular risk estimated by the SCORE scale, in general practice consultations of the 7~     French regions (Paris area, North-East, Paris basin, West, South-West, South- East,~     Mediterranean area)~   "
172421|NCT01308281|"~     This study is designed as a prospective, randomized, multi-center trial to demonstrate an~     inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting~     stents(EES) at long lesions(> 28 mm) in clinical outcomes at 12 months as a primary objective~     and safety of 6- month dual antiplatelet therapy following EES implantation in comparison~     with a 12-month dual antiplatelet therapy.~   "
172422|NCT01308268|"~     The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a~     highly endemic area in northern Argentina with a multidisciplinary approach. The specific~     objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology~     method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration~     regimen with albendazole and ivermectin.~   "
172423|NCT01308255|"~     This is a placebo controlled randomised clinical trial.Patients attending Yorkshire Early~     Arthritis Clinics and diagnosed with rheumatoid arthritis with symptom duration of 3−12~     months will be recruited. They will be randomised to blinded therapy with either methotrexate~     and intravenous corticosteroid at baseline, or methotrexate and intravenous infliximab~     according to the standard treatment regime. Patients will be followed regularly, and at each~     visit, if the patients are not in remission, they will be given an intramuscular injection of~     corticosteroid. After 26 weeks, all patients will be unblinded and those with an inadequate~     treatment response will be treated according to a dose escalation algorithm until they~     achieve remission. Those in remission will continue on blinded therapy and if 6 months of~     remission is achieved the intravenous agent (infliximab or placebo) will be withdrawn.~   "
172424|NCT01308242|"~     Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis~     of phosphorus. Elevated FGF23 levels are well-documented in patients with Chronic Kidney~     Disease (CKD) and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23~     levels are also predictive of progression of CKD and predict mortality in CKD. Although~     studies in normal individuals suggest that phosphorus intake is related to FGF23 levels, the~     effect of dietary and pharmacologic phosphate restriction on FGF23 levels in patients with~     CKD has never been reported. Our objectives are to determine if phosphate reduction through~     the use of non-calcium based phosphate binder will decrease serum FGF23 levels. The~     investigators will also be investigating associations of elevation in FGF 23 levels with~     commonly encountered co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes~     Mellitus, and Hypertension.~   "
172425|NCT01308229|"~     The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting~     Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in~     native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side~     branch reference vessel diameter of 2.0-3.0 mm.~   "
172426|NCT01308216|"~     The aim of this study is to determine the efficacy of transcranial laser therapy applied in~     automatic noncontact scanning mode for improving functional disability in patients with~     hemiplegia from ischemic stroke undergoing a rehabilitation program.~   "
172427|NCT01308203|"~     -  Clinical studies with statins have shown that patients that suffered a cardiovascular~          event have a high residual risk. Residual risk decreases with the attaining of~          progressive lower LDL-C levels.~        -  In patients treated with statins, HDL-C level is an independent inverse predictor of~          subsequent CV and coronary plaque progression, even when LDL-C levels are less than 70~          mg/dL.~        -  Therefore the purpose on this study is to assess the lipid efficacy on lipid profile and~          effects on HDL-C metabolism and function of the extended release niacin/laropiprant~          combination added to usual therapy in very high risk patients with cardiovascular~          disease and low HDL-C that did not achieve the optional very low LDL-C or non-HDL-C~          goals~   "
172428|NCT01308190|"~     The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME). The~     technique involves a low anterior rectal or colo-anal resection, very often associated with a~     protective stoma or abdominal-perineal resection with permanent colostomy. Transanal~     endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal margin, with~     minimal postoperative morbidity and mortality. Recent studies of T1 rectal adenocarcinomas~     consider TEM to be the technique of choice. However the treatment of T2 rectal cancers~     remains controversial. Chemotherapy and radiotherapy (CT/RT) has achieved a concomitant~     reduction in local recurrence and an increase in survival.~      Hypothesis: Patients with rectal adenocarcinoma less than 10 cm from the anal margin and up~     to 4 cm in size, staged after endorectal ultrasound and MRI as T2 or superficial T3~     N0-M0-N0-M0, who underwent surgery after preoperative local chemoradiotherapy (TEM), achieve~     effective results in terms of local recurrence similar to radical surgery (TME).~      OBJECTIVES:~      Primary: To compare the results of local recurrence at 2 years in patients treated with~     preoperative chemoradiotherapy and TEM and in patients treated with conventional radical~     surgery (TME).~      Secondary: To analyse the 3-year survival results in patients treated with CT/RT.~      Methodology: Multicenter clinical trial in a calculated sample of 173 patients.~   "
172429|NCT01308177|"~     -  Endoscopic submucosal dissection (ESD) is widely indicated to treat gastric adenomas and~          early gastric cancer (EGC).ESD is able to obtain en bloc resection of larger specimens.~          However, ESD has more frequent complications (delayed bleeding, ulcer healing, ulcer~          pain, and etc) due to a more complex procedure. To prevent delayed bleeding, to induce~          rapid ulcer healing, and to control the ulcer pain acid-suppressing agents (PPI, H2RA)~          are generally administered. although PPIs are widely indicated as first-line drugs for~          peptic ulcers, PPI drugs are not fully superior to H2RAs or other combination drugs for~          treatment of iatrogenic ulcer healing and delayed bleeding.~        -  Ecabet sodium (ES)is a widely used mucoprotective agent for the treatment of gastric~          ulcers. Recently, one study showed the additional benefits of using ES in combination~          with the PPI after ESD. however, this study did not show the difference of delayed~          bleeding and the benefit of ulcer pain control. thus, our study prospectively evaluated~          the difference of delayed bleeding and the benefit of ulcer pain control after ESD.~   "
172476|NCT01307540|"~     Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients.~      Methods: patients will be treated with either active light-emitting device or inactive~     light-emitting device. Daily treatment with light therapy will start at the beginning of the~     conditioning regimen and will last until day 21 post-transplant. Each daily treatment last~     about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a~     weekly basis.~   "
172430|NCT01308164|"~     The objective of this feasibility study is to evaluate the efficacy and safety of automated~     determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration~     and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1~     diabetes.~      Study design:~      Prospective study with two segments: (i) Pilot study, 30 days trial evaluating the MD-Logic~     pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic~     pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be~     initiated after the pilot segment (including data analysis). The pilot segment will include~     15-30 pediatric patients. In the RCT, up to 105 (50 minors under this protocol and 55 adults~     under a separate protocol)eligible subjects will be enrolled to allow for 92 valuable~     subjects at the end of the study. The subject population will be randomly assigned 1:1 to~     either the intervention group or control group. At this pediatric sub study approximately 50~     patients will participate and at the separate Adults study additional 55 adult patients will~     participate.~   "
172431|NCT01308151|"~     Aim:~      To adapt and develop a culturally appropriate psychological intervention and test its~     feasibility, and acceptability for the patients presenting to general hospital following~     self-harm in Karachi Pakistan.~      Primary hypothesis:~      Patients who receive cognitive behavioral therapy will show significant decrease in suicidal~     ideation as compared to patients with treatment as usual.~      Design:~      Randomized Control Trial~      Setting:~      Medical Departments of General Hospitals in Karachi.~      Participants:~      A total of 200 self harm patients will be randomized to psychological intervention and~     treatment as usual arm.~      Intervention:~      Culturally Adapted Cognitive Behavioral Therapy (CBT)~      Outcome measure:~      Beck Suicidal Ideation Scale~   "
172432|NCT01308138|"~     The main focus of the project is to determine to what degree myocardial energy metabolism is~     linked to impaired function in human cardiomyocytes, whether exercise training and remote~     ischemic preconditioning can restore cardiomyocyte function and whether this is linked to~     improved mitochondrial and cell function.~   "
172433|NCT01308125|"~     Pressure intermittent coronary sinus occlusion (PICSO) in patients with coronary artery~     disease improves collateral flow index to higher than 30%. PICSO used in this patient~     population is safe, feasible and effective. Safety, feasibility and effectiveness will be~     tested by periprocedural and logistic data.~   "
172434|NCT01308112|"~     The purpose of this study is to compare the presence of Plasmodium infection in parturient~     women who antenatally received a combination of iron-fortified foods with iron supplements~     versus iron-fortified foods only.~   "
172435|NCT01308099|"~     The purpose of this study is to see if people with Postural Tachycardia Syndrome (POTS) have~     different levels of certain chemicals in their blood than people who don't have POTS. This~     study will test whether the blood vessels of people with POTS will react differently to~     certain tests than people without POTS.~      The hypothesis of the study is:~      Patients with POTS will have vascular endothelial dysfunction compared with control subjects.~   "
172436|NCT01308086|"~     The purpose of this study is to compare whether a 3-month treatment is at least not inferior~     to a 6-month treatment (FOLFOX-4 6 vs. 12 cycles or XELOX 4 cycles vs. 8 cycles) in terms of~     RFS in patients with high risk stage II or stage III radically resected colon cancer.~   "
172437|NCT01308073|"~     The investigators aim to show, whether all middle molecules are included in the clearance and~     whether this clearance is stable until 72 hours.~   "
172438|NCT01308060|"~     This double-blind study has two parts for each subject (same population):~      Part A: initial treatment in CL (placebo-controlled):~        -  To assess the efficacy, safety and duration of effect of Azzalure® compared to placebo~          in the improvement of moderate to severe Lateral Canthal Lines.~        -  To assess the subjects' level of satisfaction with the appearance their Lateral Canthal~          Lines compared to placebo.~      Part B: repeated treatment in CL with or without GL (active treatment, up to 1 year):~        -  To assess safety of Azzalure® following repeated administration in the improvement of~          moderate to severe Lateral Canthal Lines.~        -  To assess the safety of Azzalure® when used concomitantly for improvement of moderate to~          severe Lateral Canthal Lines and Glabellar Lines.~        -  To assess the subjects' level of satisfaction with the appearance their Lateral Canthal~          Lines.~   "
172439|NCT01308047|"~     The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine~     with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for~     Orthopedic Procedures in the Lower Limbs.~   "
172440|NCT01308034|"~     The purpose of this study is to determine the safety of continuous dosing of sunitinib in~     association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor)~     sarcomas who cannot be treated by surgery.~      The primary objective of the study is to determine the maximum tolerated dose (MTD) of~     continuous dosing of sunitinib in association with radiotherapy in patients with non GIST~     sarcomas who cannot be treated by surgery.~      This study is a multicentre, open-label phase I with dose escalation : 3 dose levels.~      3-6 patients will be included at each dose level.3-18 patients will be included in the study.~   "
172441|NCT01308021|"~     The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived~     peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.~   "
172442|NCT01308008|"~     The goal of the proposed research is to test whether a long-term exercise program in~     sedentary Veterans with diabetes will produce sustained improvement in mobility performance~     and physical activity. In this proposed research, 240 sedentary older adult diabetics (aged~     60 and over) will be randomly allocated into a customized, primarily home-based,~     functionally-oriented exercise program with nurse support intervention (I) group versus a~     flexibility and toning, health education control (C) group, and test outcomes in functional~     mobility and physical activity at 4 weeks, 6 months and one year. This research can lead to~     an exercise/PA enhancement program that can coordinate with VA outreach programs, targeting~     older Veterans who are not in the immediate vicinity of a major VA site. Ultimately, this~     should create a model to which physicians and other providers could refer comorbid diabetes~     patients.~   "
172489|NCT01307371|"~     The purpose of this study is to investigate the efficacy and mechanism of bone marrow~     mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with~     ST-segment elevation myocardial infarction (STEMI)who have undergone percutaneous coronary~     intervention (PCI).~   "
172443|NCT01307995|"~     The aim of this study is to evaluate the reduced incretin effect observed in patients with~     T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and~     iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post~     partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in~     patients with other forms of DM. The investigators estimate that approximately 90 % of the~     patients with GDM re-establish a NGT 2-3 months post partum. This particular group of~     patients provides a unique possibility for demonstrating the reversibility of the reduced~     incretin effect in relation to optimal glycaemic control.~   "
172444|NCT01307982|"~     This trial is a randomized controlled trial of two standard anti-reflux procedures, Nissen~     fundoplication versus gastrojejunal feeding tubes (GJ tubes), in children and adolescents~     with functional and intellectual impairment who have gastrostomy feeding tubes and medically~     refractory or severe gastroesophageal reflux disease (GERD). This is a pilot study to~     establish feasibility before initiating a multi-centered study.~   "
172445|NCT01307969|"~     This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated~     ropivacaine formulation for dental anesthesia.~   "
172446|NCT01307956|"~     This phase II trial is studying how well giving panitumumab, combination chemotherapy, and~     radiation therapy together before surgery works in treating patients with advanced esophageal~     or gastroesophageal (GE) junction cancer. Monoclonal antibodies, such as panitumumab, may~     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,~     such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells.~     Giving monoclonal antibody therapy together with chemotherapy and radiation therapy before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~   "
172447|NCT01307943|"~     Mindfulness-based stress reduction (MBSR) is a group program in which participants are taught~     to be mindful or present-focused. MBSR programs consist of instruction in a variety of~     mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion~     of these practices. Our study purpose is to develop and conduct a pilot mixed-methods~     randomized controlled trial (RCT), combining clinical outcomes, qualitative interviews, and~     brain imaging to assess the impact of the intervention on children with mental health~     challenges.~   "
172448|NCT01307930|"~     This study will find how weight affects the dosing of a drug called anidulafungin. Currently,~     the amount of anidulafungin a patient receives is the same regardless of the patient's~     weight. BMI groups were for enrollment purposes only and not used for ordinal data analysis.~   "
172449|NCT01307917|"~     Diabetes is the most common metabolic disease of childhood. Vascular disease is a leading~     complication of diabetes, and attempts to maintain close glycemic control do not prevent the~     sequelae that claim the lives and quality of life of millions of diabetics each year. Up to~     forty percent of patients with diabetes mellitus ultimately develop diabetic nephropathy, the~     most common cause of end-stage renal disease requiring dialysis in the US. Flavonoid-rich~     diets are a promising intervention to prevent the endothelial dysfunction that apparently~     leads to this deadly complication. The mechanisms are still unclear but probably involve~     nitric oxide synthesis. The investigators hypothesize that early maintenance of the integrity~     of renal vasculature will significantly improve the lifelong prognosis for patients with~     diabetes. Flavonoids with anti-inflammatory and antioxidant activities could be used to~     protect endothelial function, and together with good glycemic control, prevent the~     development and progression of nephropathy. The investigators aims are to:~        1. compare endothelial function by studying reactive hyperemia, nitric oxide, and~          proinflammatory factors in adolescents (12-21 years old) with diabetes versus healthy~          sex- and age-matched control subjects.~        2. identify early markers in urine for vascular endothelial injury.~        3. examine the effects of flavonoids on vascular function, urine nitric oxide, and~          proinflammatory factors in patients with diabetes mellitus.~   "
172450|NCT01307904|"~     The main objectives of this study is to measure the composition of five common types of dates~     (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of~     these dates tested in healthy and diabetic subjects. Thirteen healthy volunteers and ten~     subjects with type 2 diabetes mellitus were enrolled in the study.~      The dates' flesh composition analysis showed that the dates contain a high percentage of~     carbohydrate (total sugars, 65-68%).~      The measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5,~     46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively.~     Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar~     46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified~     as low glycemic index food items.~   "
172451|NCT01307891|"~     Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer~     deaths in American women. Metastatic disease including metastatic breast cancer unfortunately~     remains incurable. One reason is due to the inability to develop specific therapies for~     specific cancer subsets.~      The use of modern genomic techniques has significantly enhanced our recent understanding of~     breast cancer biology. Five distinct breast cancer subsets have been recognized, one of which~     is basal-like breast cancer. Basal-like breast cancer is typically estrogen receptor (ER)~     negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2~     (HER-2-Neu) negative. This is referred to as triple negative breast cancer or TBNC. TBNC~     represents a significant proportion of breast cancer patients (10-20%) and has a poor~     prognosis with no targeted approach to therapy as of yet.~      Tigatuzumab is a humanized monoclonal antibody targeting a death receptor on the breast~     cancer cells. Previous studies have shown that combining antibodies with selected~     chemotherapy agents have induced tumor cell death. The hypothesis of this study is to use~     tigatuzumab and combine it with Abraxane to serve as a targeting agent in metastatic TBNC~     patients.~   "
172452|NCT01307878|"~     Evaluation of new adjuvant chemotherapy for unresectable liver metastasis of colorectal~     cancer without bleeding, obstruction, etc.~   "
172638|NCT01305421|"~     ICU patients do experience extubation failure. Guidelines rarely include muscle strength~     criteria. Prior work indicates that grip strength is a reliable surrogate for muscle~     strength. The purpose of the study is to assess the success rate of mechanical ventilation~     weaning based on the grip test.~   "
172453|NCT01307865|"~     The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic~     rejuvenation of the midface complex. The investigators plan to both qualitatively determine~     the restoration of midface architecture as well as quantitatively document the change in~     midface volume by employing three-dimensional (3D) surface imaging which critically analyzes~     volumetric tissue changes. Our hypothesis is that patients who receive Sculptra Aesthetic~     injections will experience significant improvement in facial midface volume restoration.~        -  Measure the midfacial volumetric correction from Sculptra Aesthetic treatment, using~          three-dimensional digital surface imaging~        -  Determine the mean change from baseline in facial contour via quantitative volumetric~          measurements~        -  Correlate volumetric correction with clinical improvement as measured by the Facial~          Lipoatrophy Panel grading system~        -  Correlate the mean volumetric change in midfacial treatment area with the amount of~          product used~        -  Obtain photographs pre- and post-treatment for the purpose of providing a subject visual~          aid during the course of treatment~        -  Collect safety data~   "
172454|NCT01307852|"~     The goal of this clinical research study is to learn if a rectal balloon with attached~     radiation detectors can be used to help researchers monitor the dose of external beam~     radiation that is delivered to the prostate during treatment. This may help researchers~     better understand the side effects of radiation therapy, such as rectal bleeding, and may~     lead to changes in treatment planning or treatment delivery.~   "
172455|NCT01307839|"~     Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural~     placement in laboring parturients1. Skin infiltration, although brief, can be very stressful~     and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing~     the pain and decreasing the satisfaction with the procedure. To reduce this discomfort,~     various topical alternatives have been investigated with varying degrees of success.1-4 Now~     that a topical mixture of lidocaine that is safe and effective is available, the~     investigators would like to determine if it can reduce the pain of skin infiltration in~     particular and epidural placement as a whole.~   "
172456|NCT01307826|"~     The purpose of this study is to compare classical massage and massage based on the tensegrity~     rule in treating people with painful shoulder.~   "
172457|NCT01307813|"~     The Overstitch (Apollo Endosurgery, Austin, Texas) is an FDA cleared product which attaches~     to a standard double channel endoscope. The Overstitch can place sutures under endoscopic~     guidance, with the goal of reproducing standard surgical techniques. These would include~     hemostasis, tissue approximation, anastomosis formation, fixation of intraluminal devices, or~     repair/closure of mucosal or full thickness defects such as perforations or endoscopic~     mucosal resection (EMR) sites. Knot tying of the endoscopically placed sutures is provided by~     an endoscopic cinching device that passes through the channel of the endoscope.~      This feasibility trial will evaluate the ability of the Apollo suturing device (Overstitch)~     to endoscopically place sutures into normal mucosa, and then tie the sutures with the~     cinching device. These devices have been utilized effectively in explant, live porcine, and~     human cadaver colon and stomach models. In this treat and resect model, sutures would be~     placed in a segment of colon or stomach that is being surgically removed via open or~     laparoscopic technique for the treatment of benign or malignant disease. The sutures would be~     placed in a segment of normal mucosa remote to the pathology being surgically treated. In~     addition, the sutures will be placed under direct observation via laparoscopic or open~     visualization. After resection of the segment of colon, it will be evaluated grossly for~     level of suture placement, evidence of perforation, and quality of suture approximation with~     the cinching device.~   "
172458|NCT01307800|"~     The purpose of this study is to determine whether at least 1 dose level of LY2140023 given to~     acutely ill patients with schizophrenia will demonstrate significantly greater efficacy as~     compared to placebo.~   "
172459|NCT01307787|"~     The purpose of this study is to evaluate the effects of a group-based exercise and~     educational program for people with Rheumatoid Arthritis (RA) on physical performance and~     disease-self-management.~   "
172460|NCT01307774|"~     To conduct a quantitative survey to measure knowledge about Human papillomavirus (HPV) and~     cervical cancer, and HPV vaccine acceptability among parents of rural adolescent girls in~     Mysore District, India.~      Hypothesis: General knowledge and attitudes about the severity and treat ability of cancer~     will predict acceptability of HPV vaccination among parents of rural adolescent girls in~     Mysore, India.~   "
172461|NCT01307761|"~     The purpose of the investigators study is to retrospectively evaluate the predictors of~     malignant thyroid nodules and established an useful scoring system based on sonographic~     findings and demographic data.~   "
172462|NCT01307748|"~     The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how~     aromatherapy works.~   "
172463|NCT01307735|"~     Myocarditis is an inflammatory heart disease primarily of viral origin that can lead to heart~     failure and death. Despite an unfavorable long-term outcome and mortality rate as high as~     50%, classification, diagnosis, and treatment of myocarditis remains controversial. The gold~     standard for clinical diagnosis is direct sampling of the heart muscle, which often misses~     the infected area and thus reliability of the test is questionable. While the cause and~     clinical presentation of myocarditis are often unclear, inflammation of the heart muscle can~     be clearly imaged by Cardiovascular Magnetic Resonance Imaging (CMR).~      Due to recent international consensus on CMR protocol for myocarditis and the unique ability~     of CMR to visualize cardiac structure, function, and characterize tissue, CMR has become the~     primary tool for clinical assessment. This study aims to test the accuracy of CMR in the~     diagnosis of myocarditis and to validate whether CMR acquired in an early stage of~     myocarditis can provide incremental prognostic information. In order to effectively gather~     relevant clinical data, an online, multi-centre international registry will be established~     across twenty different medical institutions.~      Hypotheses:~        1. CMR accurately detects active myocardial inflammation in patients with myocarditis~        2. CMR acquired in an early clinical stage of myocarditis provides incremental prognostic~          information superior to standard clinical diagnostic tools.~   "
172490|NCT01307358|"~     The purpose of this research study is to compare the interproximal plaque removal ability of~     Philips Sonicare Interproximal Cleaning Device to floss (Crest Glide) and Waterpik~     Waterflosser. In addition, we seek to learn more about the results of using this device on~     plaque accumulation and what biological processes influence the makeup of plaque and~     reduction of gingivitis.~   "
172464|NCT01307722|"~     Background and Purpose- According to our prior studies, left atrial (LA) distensibility was~     associated significantly with left ventricular filling pressure in patients with acute~     myocardial infarction (AMI), chronic stable angina, and severe mitral regurgitation. LA~     distensibility can be used as noninvasive Swan-Ganz catheter. Additionally, it could predict~     in-hospital mortality in AMI patients. In the current study, left atrial distensibility~     guiding management in advanced chronic heart failure will be performed to assess whether~     those management could influence long-term prognosis including mortality rate,~     rehospitalization rate and the duration of rehospitalization.~      Materials and Methods- Advanced chronic heart failure (HF) is defined as left ventricular~     ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class~     III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart~     failure requiring adjustment of inotropic agents or diuretics within recent 6 months. Three~     hundred HF cases will be recruited - 100 with sinus rhythm, and 100 with atrial fibrillation~     served as LA distensibility guided treatment group (guide group) and another 100 patients,~     either sinus rhythm or atrial fibrillation, served as control group. The management of guide~     group will be adjusted by LA distensibility, including the dose of inotropic agents,~     diuretics, beta-blocker, ACEI, and AIIB. Initially, the guide group will be followed 1 time~     per 2 week at first 3 months, then 1 time per month later. The control group will be treated~     by conventional management and traditional echocardiography can be performed as in-charge~     doctor request. The necessity of hospitalization for heart failure will be adjusted by 2~     cardiovascular specialists and all patients admitted for heart failure will be managed by the~     same one cardiovascular specialist (Shih-Hung Hsiao). The total duration of follow-up will be~     2 years. For life-threatening heart failure, intravenous nitroprusside drip under continuous~     A-line monitor, percutaneous coronary intervention, Swan-Ganz catheter insertion,~     intra-aortic balloon pump, and ECMO can be done according to the order of in-charge doctor.~     The primary end-point will be all-cause mortality. The second end-points will be heart~     failure with hospitalization and the duration of each hospitalization. Additionally, the~     ratios of medication changes in 2-year follow-up, including diuretics, inotropic agents, beta~     blockers, ACEI, and AIIB, will be assessed. Analysis will also be performed to estimate the~     trends of heart function (either systolic or diastolic) and renal function during 2-year~     follow-up according to whether guiding by LA distensibility is done or not.~   "
172465|NCT01307696|"~     Meshes-devices using dual-sided mesh technology have been developed for the specific~     indication of small ventral hernias. The design of these meshes allows introduction of a mesh~     of appropriate size to cover the hernia defect, through a small incision. This technique is~     very attractive for the surgeon and the patients because the mesh usually can be introduced~     through a nearly invisible scar in the umbilicus. The avoidance of fixation sutures omits the~     pain related to these sutures. Short-term results and patient satisfaction are very~     favorable, encouraging the surgeons to continue with the technique, although long-term~     results of these meshes in good quality studies are lacking.~   "
172466|NCT01307683|"~     The MAMAS study is built on the premise that simple recommendations for diet and exercise may~     not be enough to encourage healthy weight gain during pregnancy. Psychological skills~     training may be necessary to help women deal with stress and cravings; learn to regulate~     difficult emotions; increase awareness; and encourage healthy eating and physical activity.~     The goal of this study is to find out whether a behavioral stress reduction intervention can~     help women achieve healthy weight gain during pregnancy and reduce stress.~   "
172467|NCT01307657|"~     The purpose of this study is to determine whether a high-fat meal affects the ability of~     platelet function tests to measure platelet inhibition by clopidogrel.~   "
172468|NCT01307644|"~     This project will evaluate an Internet delivery strategy to address weight loss and~     maintenance among rural midlife and older women.~   "
172469|NCT01307631|"~     This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with~     recurrent or advanced endometrial cancer. Akt inhibitor MK2206 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
172470|NCT01307618|"~     This randomized phase II trial is studying how well giving vaccine therapy together with or~     without recombinant interleukin-12 followed by daclizumab works in treating patients with~     melanoma that has spread to other places in the body. Vaccines made from peptides or antigens~     may help the body build an effective immune response to kill tumor cells. Recombinant~     interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating~     white blood cells to kill melanoma cells. Monoclonal antibodies, such as daclizumab, may~     decrease the number of regulatory T cells (T cells that suppress the activation of the~     immmune system) and may lead to a better immune response against melanoma. It is not yet~     known whether vaccine therapy is more effective with interleukin-12 and daclizumab in~     treating melanoma.~   "
172471|NCT01307605|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Lenalidomide may stop~     the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. It is not yet known~     whether rituximab is more effective when given alone or together with lenalidomide in~     treating patients with follicular lymphoma.~      PURPOSE: This randomized phase II trial is studying rituximab to see how well it works~     compared with giving rituximab together with lenalidomide in treating patients with~     previously untreated follicular lymphoma.~   "
172472|NCT01307592|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, oxaliplatin, and ,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell~     growth in different ways. Some block the ability of cancer cells to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide~     may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving~     rituximab and chemotherapy together with lenalidomide may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab, gemcitabine~     hydrochloride, and oxaliplatin together with lenalidomide works in treating patients with~     relapsed or refractory, aggressive non-Hodgkin lymphoma.~   "
172473|NCT01307579|"~     This randomized phase III trial studies caspofungin acetate to see how it works compared to~     fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia~     who are undergoing chemotherapy. Caspofungin acetate or fluconazole may help prevent fungal~     infections caused by chemotherapy. It is not yet known whether fluconazole is more effective~     than caspofungin acetate in preventing fungal infections in patients with acute myeloid~     leukemia who are undergoing chemotherapy.~   "
172474|NCT01307566|"~     The main purpose of this study is to measure the evolution of hemoglobin A1c level after~     treatment with CPAP in a cohort of type 2 diabetes mellitus patients with poor glycemic~     control and associated moderate or severe obstructive sleep apnea.~   "
172475|NCT01307553|"~     The purpose of this study is to track the clinical safety and effectiveness of the~     Pericardium Covered Stent in real world use.~   "
172526|NCT01306890|"~     The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs)~     following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.~   "
172477|NCT01307527|"~     Brittle Cornea Syndrome and Ehlers-Danlos Syndrome (EDS) type VI are rare collagen-connective~     tissue disorders that predispose affected individuals to the development of perforated~     corneas from the mildest of eye trauma or even spontaneously. Clinical studies evaluating~     riboflavin-corneal crosslinking have found that it dramatically increases corneal rigidity.~     Given the success and safety of riboflavin crosslinking, the investigators believe that it~     can increase the corneal stability in patients affected these disseases, preventing~     perforation. It is furthermore possible, that riboflavin crosslinking will allow corneal~     transplants to successfully be performed on blind eyes that have already perforated and~     opacified. The purpose of the study is to determine whether corneal crosslinking can be~     safely performed on individuals with Brittle Cornea Syndrome or Ehlers-Danlos Syndrome type~     VI.~   "
172478|NCT01307514|"~     The aim of this experiment is to test the pharmacodynamics and pharmacokinetics of insulin~     analogs and their dependence on external and physiological alterations. The investigators~     plan compare the pharmacodynamics of insulin analog delivery in regular conditions and in the~     presence of increased perfusion of the delivery site, achieved by way of local warming,~     movement and topical application of Capsaicin cream. The investigators will also test the~     effect of local heating and topical application of Capsaicin cream on the post prandial~     glucose levels following a bolus.~   "
172479|NCT01307501|"~     ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors~     less than or equal to 3.5 cm in patients with pulmonary metastatic disease.~   "
172480|NCT01307488|"~     A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected~     subjects in their first antiretroviral regimen and who are virologically suppressed on a~     regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to~     ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.~   "
172481|NCT01307475|"~     Freeman-Sheldon syndrome (FSS) is a rare human neuromusculoskeletal disorder present before~     birth, involving primarily limb and craniofacial deformities.~      The hypotheses in the present study of FSS and related conditions are: (1) FSS and related~     conditions are associated with higher rates of posttraumatic stress symptoms (PTSS),~     depression, and reduced quality of life than is observed in the general population; (2)~     persons close to an individual with FSS or related condition suffer similarly; and (3)~     current measures, which are single-disease specific (i.e., PTSS, depression, craniofacial~     deformities, or limb deformities), do not capture the unique picture of FSS and related~     conditions, which involve both limb and craniofacial deformities in an intellectually capable~     individual.~      There have been no studies looking at quality of life associated with FSS. Some authors have~     looked at quality of life in persons with facial differences; other authors have looked at~     bone and joint problems. Many other authors have looked at PTSS and depression caused by~     health problems and bad medical experiences. No authors have looked at these problems when~     they happen together, as they do in FSS. Because of the above, there may be differences in~     patients that have FSS versus patients in previous quality of life studies. The study will~     also develop and validate an outcomes-based quality of life survey for FSS and related~     conditions.~   "
172482|NCT01307462|"~     This phase II trial studies how well giving fluticasone propionate, azithromycin, and~     montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans~     who previously underwent stem cell transplant. FAM may be an effective treatment for~     bronchiolitis obliterans~   "
172483|NCT01307449|"~     Vaccination is the most effective way of preventing infectious diseases. Despite the success~     of vaccines in general, vaccines induce diminished antibody responses and lower protection in~     the elderly in particular. This could be explained by a defect in the early responses of an~     ageing immune system. A better understanding of the basic immunological mechanisms that~     mediate vaccine efficacy is incomplete. Such information is critical and could greatly~     decrease both the cost and the time to new vaccine development particularly for the geriatric~     population.~      In this trial, the investigators will study the immunologic differences of two FDA approved~     licensed pneumococcal vaccines between a younger and an older group. Twenty two healthy~     volunteers between the age of 25-40 and sixty six healthy volunteers between the ages of~     60-89 will be enrolled in the study. Each participant in the study will be given one~     pneumococcal shot. Blood work will be obtained prior to vaccination, one day, three days,~     seven days, fourteen days, as well as one month and six months after vaccination. Throughout~     the duration of the study, the participants will be monitored for safety.~   "
172484|NCT01307436|"~     The primary purpose of this study was to assess whether the protection afforded by Epaxal~     vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus~     influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and~     (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the~     protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain~     information on the long term protection afforded by Epaxal, and to compare this with an~     alternative hepatitis A vaccine (Havrix).~   "
172485|NCT01307423|"~     The purpose of this study is to determine whether apremilast is safe and effective in the~     treatment of patients with psoriatic arthritis who have not been previously treated with~     DMARDs.~      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and~     swollen joints, pain, physical function) in treated patients.~   "
172486|NCT01307410|"~     In 2010, the sponsor conducted an observational study, entitled as Nationwide Assessment of~     Cardiovascular Risk Factors: Blood Pressure, Blood Lipid, and Blood Glucose, in Chinese~     Patients with Type 2 Diabetes - 3B Study  which was to evaluate the level of cardiovascular~     diseases (CVD) risk factor control and its regional difference in China. As a continuation,~     this extension of the 3B Study is designed to assess the incidence of cardiovascular events,~     cardio-renal events, and other microvascular complications, in 1, 2 and 3 years in patients~     with type 2 diabetes and with high risk of (CVD) with or without existing or history of~     coronary artery diseases.~   "
172487|NCT01307397|"~     This multi-center study evaluates the safety and efficacy of vemurafenib in participants with~     BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV~     (American Joint Committee on Cancer [AJCC]) metastatic melanoma.~   "
172488|NCT01307384|"~     This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain~     survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used~     in primary total hip arthroplasty.~   "
172491|NCT01307345|"~     This pilot project proposes to monitor real-world alcohol use using a novel technology—cell~     phone videorecordings in conjunction with breathalyzer recordings—and to conduct a small~     randomized study of this technology for reinforcing alcohol abstinence. Individuals with~     frequent alcohol use (N = 30) will be asked to carry a study cell phone plus a handheld~     breathalyzer for one month. Participants will be randomized to one of two conditions: alcohol~     monitoring or alcohol monitoring plus contingency management. In both conditions, research~     assistants will telephone participants on their cell phone an average of 10 times per week to~     request submission of a breathalyzer sample using the video monitoring function on the cell~     phone. Samples will be time and date stamped, and the video containing the breathalyzer~     result will be sent to study staff via the cell phone. Participants will be compensated for~     each video recorded within one hour of receiving the prompt. Participants randomized to the~     contingency management condition will receive the same alcohol monitoring described above,~     and they will also receive reinforcement for each alcohol negative breath sample submitted~     within one hour of the prompt. Data from this pilot project will be useful for (1)~     determining the feasibility of assessing alcohol use in the natural environment via~     breathalyzers and cell phone technology, and (2) estimating effect sizes of a CM intervention~     that reinforces alcohol abstinence using breathalyzers and cell phone technology. In an~     exploratory manner, we will also evaluate the reliability and validity of the video~     monitoring procedure and trends toward changes in psychosocial functioning.~   "
172492|NCT01307332|"~     There are two parts to this investigator sponsored trial (IST):~        1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.~        2. To provide serum samples for the University of Southern California (USC) ICAM125~          lymphocyte recovery study.~   "
172493|NCT01307319|"~     The purpose of this study is to assess the safety and efficacy of an investigational nasal~     aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal~     allergic rhinitis in children (6-11 years of age).~   "
172494|NCT01307306|"~     The central aim of this application is to determine whether improved outcomes with tight~     euglycemic control are due to insulin-specific responses. The investigators hypothesize that~     improving insulin resistance will lead to decreased inflammatory and hypermetabolic~     responses, as well as restored glucose metabolism, and so result in improved clinical outcome~     of severely burned patients.~   "
172495|NCT01307293|"~     The purpose of the study includes:~        1. To develop a treatment manual and pilot test this treatment intervention which is~          designed to prevent and reduce psychological distress in parents who have infants~          hospitalized in the neonatal intensive care unit (NICU).~        2. To conduct a treatment intervention study in which parents of NICU infants will receive~          a 6-12 session treatment designed to reduce psychological distress, and to compare~          outcomes with parents who do not receive the intervention.~      We hope to learn whether or not a simple psychotherapeutic and psychoeducational intervention~     offered to parents of NICU infants can prevent or minimize the development of symptoms of~     psychological distress in parents, including symptoms of anxiety and depression and~     posttraumatic stress disorder (PTSD).~   "
172496|NCT01307280|"~     The study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral~     weight management program, complemented by an interactive Web site and brief telephone~     coaching, implemented among TRICARE non-active-duty beneficiaries.~      A total of 1,755 participants from four Midwestern states were randomized to one of three~     randomized controlled trial groups with increasing intervention intensity: mailed material~     and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief phone- and~     Web-based coaching support from health lifestyle coaches (RCT3). The study assessed changes~     in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12,~     and 15 to 18 months. Analyses estimated overall cost savings and calculated the~     cost-effectiveness ratio of each randomized controlled trial compared with a do-nothing~     alternative as the cost per quality-adjusted life year.~   "
172497|NCT01307267|"~     A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid~     tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive~     Non-Hodgkin's Lymphoma (NHL).~   "
172498|NCT01307254|"~     The investigators hypothesize that low iron storages protects from and down-grades~     non-alcoholic fatty liver disease.~      The aim of the study is to show the association between the severity of Non-alcoholic fatty~     liver disease to low iron status.~   "
172499|NCT01307241|"~     Results of actual treatment in ALL are not optimal. New prognostic factors, which may~     determine clinical & molecular response are required. Hyper-CVAD is an internationally~     accepted schema for such patients. The objective of this pilot study is to evaluate~     polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the~     function of these proteins, and therefore the intracellular bioavailability of methotrexate.~     Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for~     citarabine intracellular transport and activation, respectively. Clinical characteristics~     will be tabulated and analyzed for responders & non-responders patients. Uni- & multivariate~     analysis will be done to evaluate factors influencing on response and survival.~   "
172500|NCT01307228|"~     The investigators have developed an online database called 'Health Systems Evidence,' which~     contains synthesized research evidence and additional details about this evidence that can~     make it easier for health system policymakers to use the included research evidence. The~     investigators have also developed an e-mail alerting service that brings to the attention of~     health system policymakers any new additions to Health Systems Evidence. This study will~     evaluate whether a full-serve version of Health Systems Evidence increases the use of~     research evidence by policy analysts and advisors in the Ontario government as compared to a~     self-serve version. The full-serve version comprises: 1) access to Health Systems~     Evidence; 2) monthly e-mail alerts about new additions to Health Systems Evidence; and 3)~     access to full-text articles that are cited in Health Systems Evidence. The self-serve~     version only provides access to Health Systems Evidence. The investigators will also~     interview study participants to obtain feedback about Health Systems Evidence, including how~     helpful it was in their work, why it was helpful (or not helpful), what aspects were most and~     least helpful and why, and recommendations for improving it.~   "
176692|NCT01252407|"~     The purpose of this study is to determine acute effect the transctutaneous electrical nerve~     stimulation in sympathetic and parassympathetic system in individuals with heart failure.~   "
172501|NCT01307215|"~     Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP~     block is a procedure used to reach the nerve endings in the abdominal wall so that there is a~     reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be~     injected after surgery. The aim of this study is to determine the effect of changes in the~     volume of the injection.~   "
172502|NCT01307202|"~     Total knee arthroplasty is amongst the most painful procedures postoperatively, and pain~     management can be a challenge. Different measures have been introduced to manage severe~     postoperative pain int hese patients. Previous studies have investigated gabapentin in acute~     postoperative pain and demonstrated reducted pain, postoperative morphine consumption,~     morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct~     has yet to be investigated in total joint arthroplasty patients.~   "
172503|NCT01307189|"~     This study was designed to test the following hypothesis:~      A) The acute and long-term (3 weeks) bronchodilator-induced changes in exercise tolerance and~     in the physiological response during the endurance shuttle walk will be greater with~     tiotropium compared to placebo in COPD patients.~      B) Three weeks of bronchodilation will be associated with increase activity of daily living~     as evaluated using the London Chest Activity Daily Living scale.~   "
172504|NCT01307176|"~     The purpose of this study is to determine whether a person's ability to adapt (i.e. short~     term motor learning) predicts their ability to benefit from physical therapy exercises.~   "
172505|NCT01307163|"~     Saliva is used nowadays as a significant diagnostic tool due to the latest technological~     developments. The research compares two experimental groups; children after liver~     transplantation and a control group.~      Our objective is to identify from all the parameters that are evaluated, the ones that differ~     between the two groups. If such parameters will be found and differ statistically, it will be~     possible to create a non invasive medical examination protocol, which will probably be much~     more complaint, and being so would help locate individuals in risk groups with the tendency~     to develop an end-organ liver disease.~   "
172506|NCT01307150|"~     The purpose of this study is to evaluate the improvement in severity of Atopic Dermatitis and~     quality of life after 4 weeks of treatment in the Dead Sea.~   "
172507|NCT01307137|"~     The prevalence of obesity and diabetes in older adults is increasing. Because older adults~     are often portrayed as less likely to change long-standing health behaviors, health promotion~     in this age group has lagged behind others. In fact, little attention has been given to the~     importance of diabetes prevention in community-dwelling older adults through the~     implementation of programs that promote healthy nutrition, increase physical activity and~     improve self-management. The Diabetes Prevention Program (DPP), which demonstrated the~     benefit of modest weight loss on the reduction of diabetes risk (58% overall reduction with a~     71% reduction in the older population), has yet to be translated into widespread public~     health practice.~      The overall objective of this protocol is to implement evidence-informed, innovative~     interventions to increase adoption of findings from comparative effectiveness research (CER)~     for diabetes management and prevention in South Florida older veterans. Specifically, the~     proposed study will test the hypothesis that Peer-led Care alone (PC), or activated by~     technology (TechnAlert-Peer or TAP), is superior to traditional methods of information~     dissemination (Usual Care or UC) for adoption of CER on prevention and management of~     diabetes, leading to better self-efficacy and clinical outcomes.~      The investigators will conduct a 12-month randomized controlled trial in older veterans with~     prediabetes and diabetes participating in one of the Healthy Aging Regional Collaborative~     programs. Primary outcomes include changes in self-efficacy, weight, and hemoglobin A1c.~     Secondary outcomes include changes in blood pressure, lipids, physical function, quality of~     life, and health care utilization and the evaluation of potential racial/ethnic disparities~     in the process of adoption of CER for prevention and management of diabetes.~      This study is expected to accelerate the implementation of CER evidence for diabetes~     prevention, addressing health and economic challenges in the care of overweight and obese~     veterans.~   "
172508|NCT01307124|"~     To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir~     containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48~     week~   "
172509|NCT01307111|"~     The purpose of this study is to see if using misoprostol makes the intrauterine device~     insertion easier and less painful in women who have never had a baby.~   "
172510|NCT01307098|"~     This is the first clinical study of SBC-102 (sebelipase alfa) for the treatment of LAL~     Deficiency. It is an open label dose escalation study in adult patients with liver~     dysfunction due to Lysosomal Acid Lipase (LAL) Deficiency and will examine three doses of~     SBC-102 (sebelipase alfa). The targeted number for this study is 9 evaluable subjects.~   "
172511|NCT01307085|"~     The purpose of this study is to determine whether ischemic preconditioning reduces lung~     injury in patients undergoing pulmonary resection.~   "
172512|NCT01307072|"~     The relationship between the surgical outcome of vitreous surgery for proliferative diabetic~     retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.~   "
172513|NCT01307059|"~     This is a Swedish, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth~     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via Easypod™.~   "
172514|NCT01307046|"~     This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension~     participants who are not adequately controlled with losartan.~   "
172515|NCT01307033|"~     This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential~     hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).~   "
172516|NCT01307020|"~     The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol~     and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single~     component in comparison to placebo on moderate to severe pain following impacted third~     mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate~     the pain model.~   "
172517|NCT01307007|"~     The primary objective of this study is to assess the safety of an investigational intravenous~     iron (ferric carboxymaltose [FCM]) or an equal dose of iron dextran and explore the mechanism~     of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran~     when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).~   "
172527|NCT01306877|"~     The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse~     Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based~     on the primary endpoint.~   "
172528|NCT01306864|"~     The objective of this study is to show that Hemospray is effective in achieving initial~     hemostasis and documenting rate of further bleed when compared to standard of care.~   "
176714|NCT01252121|"~     The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared~     to Hialid and saline.~   "
172518|NCT01306994|"~     The hypotheses of the present study of Freeman-Sheldon syndrome (FSS) and related conditions~     are: (1) that exercise capacity is lower in FSS patients versus normal controls, and the~     lower exercise capacity is due to changes in the muscles' normal structure and an inability~     of sufficient quantity of the energy molecule to bind to muscle; (2) this muscle problem~     reduces amount of air that can get in the lung and amount of oxygen carried in the blood,~     which then has the effect of increasing heart and respiration rates, blood pressure, and deep~     body temperature, and produces muscle rigidity; (3) the events noted above, when they occur~     during cardiac stress testing, are related to a problem similar to malignant hyperthermia~     (MH) reported in some muscle disorders without use of drugs known to cause MH. MH (a~     life-threatening metabolic reaction that classically is triggered when susceptible persons~     receive certain drugs used in anaesthesia.~   "
172519|NCT01306981|"~     This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery~     for the complications of diabetic retinopathy.~      Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for~     patients. Our hypothesis is that injection into the eye of ranibizumab one week before~     surgery will make the surgery easier, reduce complications and improve outcome.~      In this trial, patients will be randomly allocated to receive either ranibizumab injection or~     a placebo injection of saline. Neither the patient, their surgeon, nor the study~     investigators will know which they have received so that a fair comparison can be made.~   "
172520|NCT01306968|"~     This is a Phase II randomized trial designed to describe the magnitude of change between~     baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological tests~     administered at time points corresponding before and after 10 weeks over observation in four~     groups:~        -  A military population with post-concussion syndrome (mTBI) receiving local standard care~        -  A military population with post-concussion syndrome (mTBI) receiving local standard care~          and sham hyperbaric oxygen sessions~        -  A military population with post-concussion syndrome (mTBI) receiving local standard care~          and hyperbaric oxygen at 1.5 atmospheres sessions~        -  A otherwise similar group with PTSD but no history of TBI receiving local standard care~          Differences and variability of the tests will be used for determining the optimum~          primary endpoint(s) for future trial, as well as for refinement of sample size and power~          calculations for these studies. The groups undergoing hyperbaric sessions will be~          assigned to receive HBO2 or sham using a randomized, double blind design.~      Active duty military (Army, Marine, Navy, Air Force) men and non-pregnant women residing in~     the United States and who will remain in the military for the entire study period, aged 18-65~     years who have been deployed one or more times to the US Central Command since the initiation~     of Operation Enduring Freedom (October 7, 2001) who either:~        -  have been diagnosed with Post Traumatic Stress Disorder (PTSD) as a result of traumatic~          events that occurred during the qualifying CENTCOM deployment, but have no diagnosed or~          suspected lifetime brain injuries resulting in loss or alteration of consciousness; OR~        -  have been diagnosed with at least one mild brain injury (mTBI) with persistent (> 4~          months) symptoms sustained during one or more of those deployments~   "
172521|NCT01306955|"~     The goal of this study is to examine the efficacy of 1gram/day intravenous pulses of~     methylprednisolone on 3 consecutive days in Behcet's patients with ocular involvement. A~     total of 34 Behcet's patients referring to Behcet's clinic in Shariati hospital whose problem~     was confirmed with new international criteria of Behcet's disease (ICBD) will be randomly~     assigned into one of the two equal groups of intervention or control. Behcet's patients are~     those with ocular involvement who were under the same cytotoxic treatment with~     cyclophosphamide and azathioprine. For the patients in the intervention group, intravenous~     infusion of 1000 mg methylprednisolone in 100cc D/w 5% or 100cc D/w5% on 3 consecutive days~     will be added to treatment diet. Then treatment will begin with oral prednisolone, 0.5 mg/kg.~     After that, all the patients were followed up with no other therapeutic intervention by study~     group. The patients will be visited every 2 months by an ophthalmologist and study group for~     6 months in 3 settings. To estimate the ocular inflammation of patients, we use visual~     acuity, retinal and ocular posterior chamber inflammation index.~   "
172522|NCT01306942|"~     This is a single-arm, open-label, phase I/II study. In the phase I, patients with Human~     Epidermal Growth Factor Receptor 2 (HER2) positive MBC will be treated with paclitaxel,~     trastuzumab and increasing doses of dasatinib to determine the MTD (Maximum Tolerated Dose),~     DLT (Dose Limiting Toxicity) and RPD (Recommended Phase II Dose) of the combination. Once the~     RPD has been identified, 48 patients will be treated at that dose to evaluate the efficacy~     and safety of the combination in the phase II.~   "
172523|NCT01306929|"~     Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in~     movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized~     by chorea (involuntary movements) and a progressive loss of voluntary movement causing a~     substantial functional impairment over time. The study will assess the long-term safety of~     pridopidine and the treatment effects during long-term, open-label treatment.~   "
172524|NCT01306916|"~     Purpose: Prospective studies of patients with hyperparathyroidism are warranted to determine~     the prevalence of concurrent thyroid disease applying the current standard of pre-operative~     radioscintigraphic and sonographic imaging of the neck. Timely diagnosis and treatment of~     co-existing thyroid disease is advantageous given the well-established increased morbidity~     associated with a second neck exploration. The purpose of this study is to determine the~     prevalence and specific type of thyroid disease in patients with hyperparathyroidism, and to~     determine the frequency with which the presence of thyroid disease alters the treatment plan~     for patients with hyperparathyroidism.~      Research Design: This will be a prospective single arm observational study of up to 200~     military health care beneficiaries over the age of 18 years with primary and secondary~     hyperparathyroidism scheduled to undergo parathyroid resection.~      Methodology: Patients will undergo standard pre-operative imaging of the neck including~     ultrasonography and 99mTc-sestamibi scintigraphy. An operative plan will be developed based~     on the information obtained from history, physical examination, laboratory studies, and~     imaging studies. The number and type of thyroid disease in these patients will be determined~     based on these non-invasive studies (Objective A). A change in the otherwise standard~     treatment will include those patients having partial or complete resections of their thyroid~     glands because: a) the patients would have undergone minimally invasive surgery if not for~     the results of the imaging studies, and, b) the patients who would have undergone 3 ½ gland~     parathyroidectomy if not for the results of the imaging studies (Objective B).~   "
172525|NCT01306903|"~     The standard heart-lung machine is a major trigger of systemic inflammatory reactions,~     hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface~     and blood-air contact might represent meaningful improvements of the extracorporeal~     technology with respect to organ preservation.~      The aim of this study is the evaluation of potential differences between a minimal~     extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.~   "
172529|NCT01306851|"~     The anastomotic leak is one of the most feared complications in abdominal surgery. Certain~     control methods have been described but the incidence of that complication remains high and~     is the first cause of mortality in operations where gut anastomosis are performed.~      With the aim to prove that the use of fibrin glue in the gut anastomosis can improve gut~     cicatrization, the investigators started the recruitment of patients to that clinical trial~     in 2007 with the study hypothesis that patients with a gut anastomosis where fibrin glue was~     used, had less anastomotic leaks than that where the fibrin glue was not used.~      The investigators have calculated the number of patients necessaries to have statistical~     significant differences in 200 patients with a rate anastomotic leak expected to be higher~     than 10%.~      The study include all the patients that usually arrive to our surgery department and that are~     expected to have a high risk gut anastomosis: rectal anastomosis, GI anastomosis in the obese~     patient, small bowel anastomosis in the obstructed one and esophageal anastomosis.~      The study is randomized, simple blind where the patient does not know if they are in the~     fibrin glue group or not, and prospectively analyzed. All the clinical and laboratory or~     radiographic finds relative to the occurrence of an anastomotic leak are recorded.~   "
172530|NCT01306838|"~     Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants.~     Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal~     opening on the infant's abdomen). Infants with ostomies cannot digest and absorb food well,~     and must receive nutrition through the blood stream, i.e. parental nutrition (PN). However,~     prolonged dependence on PN can severely damage the liver and gut. Therefore, giving nutrition~     through the gut, i.e. enteral nutrition, is the primary treatment for infants with ostomies.~      Enteral fats, especially polyunsaturated fatty acids (PUFA), are most beneficial in~     stimulating gut mucosal adaptation, which begins 24 to 48 hours following bowel resection. In~     addition, the premature intestine has a rapid growth rate. It is likely that the current~     clinical practice of giving a relatively low-fat diet to infants with ostomies may not meet~     their high metabolic needs.~      The investigators hypothesize that increasing dietary fat content by early supplementation~     with MicroLipid® (ML, n-6 PUFA) and fish oil (FO, n-3 PUFA) to preserve the proper balance of~     n-6 and n-3 PUFA, may (i) improve bowel adaptation and infant growth; (ii) reduce the use of~     PN; and (iii) prevent liver damage and/or cholestasis (jaundice) in infants with ostomies.~   "
172531|NCT01306825|"~     Bone and joint infections are commonly due to Gram-positive bacteria. Treatment of these~     infections is difficult because of the need of prolonged duration of antimicrobial agents in~     combination with surgical procedure. Moreover, in recent years, a growing resistance pattern~     to various antimicrobial agents has been observed for Gram-positive bacteria. Consequently,~     there is an urgent need for new drugs with high bone penetration for the treatment of those~     infections. The investigators hypothesized that daptomycin allow to achieve high~     concentrations in bone compartments.~   "
172532|NCT01306812|"~     The interaction of MAO-A genotype and psychosocial risk, in relation to male adolescent~     criminality The interaction of 5-HTTLPR genotype and psychosocial risk in relation to~     excessive adolescent alcohol consumption The interaction of 5-HTTLPR genotype and~     psychosocial risk in relation to depressive symptoms among adolescents The interaction of~     MAO-A genotype and psychosocial risk, in relation to female adolescent criminality~   "
172533|NCT01306799|"~     Patients with severe acid reflux and/or Barrett's esophagus are recommended to take Proton~     pump inhibitors (PPIs)indefinitely to prevent complications such as strictures or the~     development of a type of esophageal cancer. Recently, some studies suggested that taking~     these medications on a long-term basis may affect the bone. Therefore, it is important to~     learn whether these medications may lead to accelerated bone loss so that effective~     preventive measures can be developed for patients who require these medications for~     acid-related conditions. Several studies reported that patients receiving PPIs for many years~     may have increased risk of hip fractures. However, it is unclear whether this is because the~     PPIs cause reduced bone density or whether the increased risk of fractures has nothing to do~     with PPIs and is because patients who require PPIs have other illnesses that cause the~     increased fractures. The purpose of the study is to learn how bone structure and bone mass~     change after long-term PPI use.~   "
172534|NCT01306786|"~     The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori~     eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.~   "
172535|NCT01306773|"~     Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.~   "
172536|NCT01306760|"~     The main aim of this research is to ascertain whether Ketamine would be a more effective~     anaesthetic for Electroconvulsive Therapy (ECT) than the standard anaesthetic. In doing so~     the investigators aim to examine the effect of ketamine on ratings of depressive symptoms,~     the number of required ECT treatments, and the effect of this anaesthetic on memory.~   "
172537|NCT01306747|"~     The effect of the Stanford Chronic Pain Self-Management Programme (CPSMP) is tested in a~     randomized controlled trial with enrollment of Danish chronic pain patients. A total of 500~     chronic pain patients is randomized into either an CPSMP intervention group or a control~     group.~      The CPSMP is brief patient education program consisting of 6 weekly sessions. Two trained~     instructors teach a group of 8-16 chronic pain patients about managing pain. The instructors~     are not health professionals but chronic pain patient themselves. The program is highly~     structured and manualized.~      Previous studies have shown beneficial effects of the CPSMP on pain, self-efficacy and~     well-being. Hence we expect the CPSMP to have an effect on various domains.~        1. Symptom reduction - lower self-reported pain in the CPSMP group compared to controls~        2. Illness perception - the cpsmp group will differ from controls in illness perception and~          have higher disease related self-efficacy~        3. Sickness behavior - the cpsmp group will have fewer sick days and lower health care~          utilization (estimated by registerbased data)than controls~        4. Quality of life - the cpsmp group will report higher life satisfaction and less social~          isolation than controls~   "
172563|NCT01306409|"~     The purpose of this study is to gain information on reticulocyte neocytolysis in patients~     treated with ESA with regard to different types of ESA.~   "
172564|NCT01306396|"~     The aim of the present study is to find out if a dietary intervention mainly focusing on~     fructose reduction has a preventive effect on the development and progression of NAFLD and~     the metabolic syndrome in overweight children.~   "
172538|NCT01306734|"~     PURPOSE: To compare crash cooling versus gradient cooling methods for patients undergoing~     planned surgery on the ascending aorta in deep hypothermic circulatory arrest. To investigate~     the impact of hypothermia and circulatory arrest on the coagulation, stress-response, and~     cerebral outcome.~      BACKGROUND: Cooling to 18 °C using extracorporeal circulation allows for circulatory arrest~     during surgery on the ascending aorta. Two different methods are used either lowering the~     temperature of the blood by 10 °C at a time, gradient cooling, or as cold as possible, crash~     cooling. The distribution of hypothermia is expected to be different for the two methods, the~     latter predominantly cooling the body core. The influence on the physiological response is~     expected to vary with the two methods. The surgical procedure and the cooling greatly elicit~     a stress response and the coagulation is profoundly influenced. There can be adverse effects~     on the neurological outcome due to the procedure. The two methods are considered equal, but~     have never been subjected to comparison. The surgery and circulatory changes can have a~     negative influence on the cerebral outcome .~      METHODS: Twenty patients between 18 and 80 yrs randomized either to crash cooling or gradient~     cooling, ten patients in each group.. Patients with severe comorbidities or known~     coagulopathy are excluded. Anesthesia and operation as performed routinely in the department.~     The primary endpoint is duration of cooling, secondary endpoints include coagulation~     parameters (thromboelastography, clot stability), stress response parameters (adhesion~     molecule expression on endothelial cells, oxidative stress analysis, inflammatory markers),~     neuropsychological tests, MRI of the cerebrum, markers of cerebral ischemia, and ultrasound~     imaging of the great vessels for detection of air bubbles. Baseline values are obtained for~     all parameters.~   "
172539|NCT01306721|"~     Primary Objective:~      - To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg -~     pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg -~     pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60)~     in patients with seasonal allergic rhinitis (SAR).~      Secondary Objectives:~        -  To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on~          nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily~          activity impairment.~        -  To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.~   "
172540|NCT01306708|"~     The adhesive capsulitis is a disease of the shoulder characterized by pain and limitation of~     movement amplitude. It is defined as for etiology, having discordant theories that related it~     to an inflammatory condition or to an algoneurodystrophy process. There is not yet a~     consensus about the best option of treatment. The non-steroidal anti-inflammatories have~     analgesic and anti-inflammatory activity, where the mechanism of action is the inhibition of~     prostaglandin synthesis. The antidepressants have been increasingly used in the control of~     chronic pain and the major action mechanism to have the analgesic effect seems to be based on~     inhibition of neurotransmitters reuptake noradrenaline and/or serotonin) in nerve cell~     endings. Literature studies associate the practice of the nerve suprascapular blockade with~     anaesthetics to good results of clinical improvement of the pain, however, so far, no~     clinical studies comparing the efficacy of the non-steroidal antiinflammatories or tricyclic~     antidepressants to nervous blockage were registered in the acute treatment of adhesive~     capsulitis.~   "
172541|NCT01306695|"~     Elderly Hispanics have a higher burden of dementia compared to Non-Hispanic Whites.~     Furthermore, Hispanic caregivers tend to have a higher burden of care for their relatives~     with dementia. The objective of this project is to conduct a randomized trial in 160 Hispanic~     relative caregivers of persons with dementia comparing the effectiveness of New York~     University Caregiver Intervention to a case management intervention lead by community health~     workers(CHW). This trial will last 6 months. The main outcomes in the trial will be changes~     in depressive symptoms measured with the Geriatric Depression Scale and caregiver burden~     measured with the Zarit Caregiver Burden Scale. This research project will be conducted by~     the Northern Manhattan Center of Excellence in Comparative Effectiveness Research for~     Eliminating Disparities (NOCERED) funded by the National Institute on Minority Health and~     Health Disparities.~   "
172542|NCT01306682|"~     This randomized, placebo controlled trial will evaluate the safety and immunogenicity of~     Trivalent Influenza Vaccine (TIV) in HIV-infected pregnant women, dynamics of transplacental~     anti-influenza antibody transfer to their newborns and kinetics thereof during early infancy.~   "
172543|NCT01306669|"~     Randomised, double blind, placebo controlled trial to assess safety, immunogenicity and~     efficacy of Trivalent Influenza vaccine in HIV uninfected pregnant women~   "
172544|NCT01306656|"~     This study will look at the effect of 2 treatment regimens that contain vitamin D in a~     six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be~     assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine~     and bones. This study should provide important information on the effect of vitamin D therapy~     in patients with PHPT. In addition, data from this study will guide physicians as to how best~     to treat their patients who have PHPT and vitamin D deficiency.~   "
172545|NCT01306643|"~     The primary objectives of this study is to evaluate the safety and efficacy of idelalisib~     (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma~     (iNHL).~      Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg~     twice per day. Treatment with idelalisib can continue in compliant participants for up to~     twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment~     at the completion of 12 cycles of treatment with idelalisib may be eligible for participation~     in a long-term safety extension study of idelalisib.~   "
172546|NCT01306630|"~     This is an open-label, multi-center, dose-finding study of tivozanib administered in~     combination with capecitabine. During the dose-escalation portion, sequential cohorts of~     subjects with advanced solid tumors will be enrolled in order to establish the maximum~     tolerated dose (MTD). If the MTD is not reached, the recommended Phase 2 dose (RP2D) will be~     determined. In the expansion cohort, subjects with locally advanced or metastatic breast or~     colon cancer will be enrolled at MTD (or RP2D) to further evaluate safety and activity of~     this combination in these tumor types.~   "
172547|NCT01306617|"~     The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics~     of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as~     dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with~     genotype 1 chronic hepatitis C virus (HCV) infection.~   "
172603|NCT01305876|"~     Yoga is becoming a part of therapies for children with emotional behavioral disorders. The~     goal is to examine the feasibility and efficacy of yoga sessions for children with emotional~     behavioral disorders at an urban elementary school.~   "
172639|NCT01305408|"~     The primary objective of the study is to determine whether armodafinil treatment, at a dosage~     of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood~     stabilizers for treatment of adults with major depression associated with bipolar I disorder.~   "
172548|NCT01306604|"~     Niemann Pick Syndrome Type C is a lysosomal storage disorder, caused by a pathological~     overload of cells with unesterified cholesterol as a result of impaired lipid transport into~     the cell, has still the problem of the difficulties of a simple and reliable analysis for the~     primary diagnosis but also for the follow-up of the disease. Therefore the primary aim of our~     project called BioNPC is the development of a new plasma biomarker for the early and~     sensitive diagnosis of the disease. The secondary aim is the testing for clinical robustness,~     specificity and long-term stability of the biomarker.~      Within the scope of the study the investigators would like to collect in the next 12 months~     from about 80 patient's plasma and parallel a simple documentation of the clinical data.~   "
172549|NCT01306591|"~     Age-related macular degeneration (AMD) is one of primary blinding eye disease among people~     over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular~     Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available~     low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized~     trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the~     effective therapeutic approach that the majority of patients in China can bear establishing a~     suitable treatment for China.~   "
172550|NCT01306578|"~     Comparing whether intravenous immune globulin or plasma exchange is superior in treating~     mechanically ventilated children with Guillain Barre syndrome.~   "
172551|NCT01306565|"~     The aim of this study is to compare the effect of high dose and low dose of Atorvastatin in~     reduction level of C-reactive protein (CRP) in patients with unstable angina and NSTEMI (Non~     ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas.~   "
172552|NCT01306552|"~     The purpose of this study is to evaluate the effectiveness of a combined parent-student~     program for smoking prevention in 7th graders in Berlin schools.~   "
172553|NCT01306539|"~     Stimulation of the subthalamic nucleus will have effects on various aspects of~     neuropsychiatric function.~   "
172554|NCT01306526|"~     Obstructive sleep apnea (OSA) is a respiratory disorder of sleep characterized by recurrent~     episodes of complete or partial upper airway obstruction, leading to intermittent oxygen~     deprivation. This results in sympathetic activation and surges in blood pressure, production~     of vasoactive substances, as well as activation of the inflammatory and procoagulant~     pathways. Epidemiological evidence indicates the prevalence of OSA is higher in patients with~     coronary artery disease than in the general population. The investigators recently showed~     that 65.7% and 41.9% of the Singapore patients admitted with myocardial infarction were found~     to have previously undiagnosed OSA and severe OSA, respectively. In a 10-year follow-up~     epidemiological study, OSA was independently associated with a higher prevalence of fatal and~     non-fatal cardiovascular events among the otherwise healthy general population. The~     investigators further showed that in patients who have undergone primary percutaneous~     coronary intervention for acute myocardial infarction, OSA was an independent predictor of~     future adverse event rates. Despite the observed association between OSA and adverse~     cardiovascular outcomes, the underlying pathophysiological mechanisms remain unclear. In this~     proposal, the investigators aim to elucidate the relationship between OSA and composition of~     coronary atherosclerotic plaques.~   "
172555|NCT01306513|"~     The purpose of this study is to show safety and feasibility to administer patients own~     mesenchymal stem cells to show signs of repair of emphysematous lung tissue~   "
172556|NCT01306500|"~     The purpose of the study is to evaluate the role of gastric lavage in preventing feeding~     problems in babies born through meconium stained amniotic fluid. It is a routine practice in~     many hospitals to perform gastric lavage in all babies born with meconium stained amniotic~     fluid after stabilisation without any supporting evidence. It is believed that meconium is an~     irritant and its presence in stomach causes gastritis and vomiting and hence the basis for~     this practice. Orogastric tube insertion and subsequent gastric lavage is not without~     complications. Potential complications will be prevented and health resources will be saved~     if this procedure is not proven to be beneficial. Therefore the investigators decided to~     study if gastric lavage reduces incidence of vomiting and other feeding difficulties as well~     as incidence of respiratory difficulties in babies born with MSAF.~   "
172557|NCT01306487|"~     The objective is to determine whether a recovery of the microstructures of the foveal~     photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual~     acuity (BCVA) is determined.~   "
172558|NCT01306474|"~     AIM: To study the expression of CD4+CD25+ high regulatory T cells in peripheral blood of~     patients with uveitis and to explore its role in the development of uveitis.~   "
172559|NCT01306461|"~     The purpose of this study is to compare the efficacy and safety of the preservative-free~     fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of~     tafluprost and timolol.~      This study will enroll patients who have ocular hypertension or glaucoma.~      The study schedule includes seven visits to the study site and three stages:~        -  washout of 5 days to 4 weeks depending on current glaucoma medication (if any)~        -  6-month study treatment period~        -  1-3 weeks post-study period~   "
172560|NCT01306448|"~     The study will assess the safety of the vibrating capsule in healthy volunteers first and~     than for constipation relief constipated individuals.~   "
172561|NCT01306435|"~     Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness~     and poor quality of live. The results are very consistent about the benefits of laser and~     exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To~     investigate the effects of Low Power Laser (LBP) associated with exercise in pain, function,~     range of motion, muscle strength and quality of life of patients with knee osteoarthritis.~      Methods: Forty patients of both sexes aged between 50 and 75 years with knee osteoarthritis~     (grade 2-4) were randomized into two groups: Laser-LBP-active dose of 3J more exercises and~     Group Placebo-LBP- placebo and exercise. Were evaluated for pain, function, range of motion,~     muscle strength and quality of life on three occasions: before starting treatment (evaluation~     1), 3 weeks after laser application (evaluation 2) and 8 weeks after completion of exercise~     (evaluation 3). There were 33 physical therapy sessions three times a week, on March 1 and~     the laser was applied in the other, only the exercises.~   "
172562|NCT01306422|"~     The objective of this clinical study was to assess the safety, tolerability, efficacy~     (effects on appetite scores, food intake) and plasma kinetics of Hoodia gordonii purified~     extract (H.g.PE), when consumed twice-daily for 2 or 15-days.~   "
172565|NCT01306383|"~     SODISWATER was a health impact assessment study investigating the effect of sunlight to~     inactivate microbial pathogens in drinking water. This study was carried out by observing~     whether children younger than 5 years old who drink solar disinfected water were healthier~     than those who did not. Health was measured by how often the children had diarrhoea or~     dysentery.~      Caregivers for the participants were given plastic bottles to place in the sun, water samples~     were then collected from these plastic bottles to be analyzed. They were also requested to~     fill in diarrhea diaries.~      TESTABLE RESEARCH HYPOTHESES:~      Health Impact Assessment: Children who use solar disinfected water will have:~      (a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth~     rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden~     (g) increased school attendance~   "
172566|NCT01306370|"~     Objectives:~      a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the~     blood losses with respect to the habitual haemostasia in patients with arthroplasty total of~     knee.~      Secondaries: To assess the treatment safety. To perform a cost- analyses.~      Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups:~     Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i~     Teixits de Catalunya), tranexamic acid and habitual haemostasia.~      Nº of participant centres: 1. Random allocation will be centralised.~      Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain~     system.~      Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery~     wound, pre and post-operative haemoglobin, units of blood transfused, post-operative~     mortality, days of hospital stay, safety of interventions assessed.~      Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a~     20% difference in the post-operative blood losses between the treatments assessed and the~     habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20%~     of withdrawals.~      Statistical analysis: The investigators will perform a comparison of outcomes through the t~     test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative~     or ordinals or qualitative, respectively. The software used will be Statistical Package for~     the Social Sciences (SPSS) version 17.~   "
172567|NCT01306357|"~     The purpose of this strictly observational, prospective, longitudinal study is to evaluate~     with sufficient precision the rate of overall treatment compliance from one year to 3 years~     of follow-up of the patients.~      Somatotropin is indicated in the long-term treatment of children with growth retardation~     related to a deficiency in secretion of growth hormone and in the long-term treatment of~     growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are~     the two indications of Zomacton® 4 mg and 10 mg injection solution.~      The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the~     administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for~     the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous~     transjection (needle-free) and can be used by the child directly or by the family after an~     initial training.~      In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a~     follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the~     compliance and duration of use of the device.~      The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device~     is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90~     patients will be treated. In the cohort studied the patients will be followed-up for 1 year~     at least and for 3 years at the maximum.~      The rate of treatment compliance will be evaluated according to the ratio of the actual~     duration of administration over the total duration recommended by the physician during the~     observation period.~   "
172568|NCT01306344|"~     1. A qualitative descriptive design.~        2. A phenomenologic approach to investigate the meaning of the ward round.~        3. Interviews of patients, nurses and physicians.~        4. A Master thesis.~   "
172569|NCT01306331|"~     This is a research study of a new experimental vaginal gel known as a spermicide, a birth~     control method that kills sperm. This spermicide, called Amphora™, is being compared to a~     commercially available spermicide called Conceptrol®, which contains nonoxynol 9; commonly~     abbreviated as N-9. Conceptrol® can help prevent pregnancy. This study will determine if this~     product prevents pregnancy when inserted into the vagina before intercourse.~   "
172570|NCT01306318|"~     The primary objective of this study is to compare the bioavailabilities of a single fixed~     dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities~     of eperisone 50 mg tablets and diclofenac 50 mg tablets in healthy human adult male subjects~     under fasting conditions.~   "
172571|NCT01306305|"~     A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal~     V fulfills the EMEA requirements for re-registration of influenza vaccines~   "
172572|NCT01306292|"~     This is an intra-subject crossover comparative safety study to evaluate the effect of~     intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.~   "
172573|NCT01306279|"~     Given the treatment burden and excess morbidity and mortality associated with acute infective~     exacerbations in cystic fibrosis, a clear understanding of the mechanisms involved in the~     origins of an infective exacerbation and the response to antibiotics is vital to improving~     long-term outcomes in CF.~      This study will examine 3 areas of interest in CF exacerbations.~        1. Bacterial biodiversity and its clinical significance~        2. The role of bacteria which are able to rapidly mutate (hypermutators)~        3. Inter-bacterial communication and its role in infective exacerbations~      Study Hypothesis 1~      Increased microbiological diversity represents a balanced community of bacteria. The presence~     of a diverse population of bacteria in CF infections therefore predicts a better outcome for~     treatment than when a population consists of a small number of more virulent organisms.~      Study Hypothesis 2~      Pseudomonas aeruginosa hypermutators can mutate much more often than ordinary Pseudomonas~     aeruginosa bacteria. Hypermutators are likely to grow better when the bacteria are under~     stress, such as during antibiotic treatment or during an infection. They are, however, weaker~     organisms because of the multiple mutations they have undergone. Their presence does not~     relate to clinical outcome but may be associated with the emergence of antibiotic resistance.~      Study Hypothesis 3~      Some Pseudomonas aeruginosa bacteria communicate with each other by secreting and responding~     to chemicals known as quorum sensing (QS)molecules. As well as affecting the behaviour of~     bacteria, these QS molecules can cause inflammation in the lung of CF patients. Selective~     growth of QS-producing organisms can trigger lung exacerbations in CF. If antibiotics kill~     this population of bacteria and QS molecule levels drop in the lung, patients recover from~     infection quickly. Failure to kill these bacteria with antibiotics allow QS molecule levels~     to remain elevated and patients to have prolonged infections.~   "
172574|NCT01306266|"~     The purpose of the study is to determine the effectiveness of rizatriptan for treating~     attacks of chronic post-traumatic headache.~   "
172575|NCT01306253|"~     This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine~     Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.~   "
172576|NCT01306240|"~     Term and near term newborns can present acute respiratory distress syndrome (RDS). Surfactant~     treatment has been shown effective in reducing mechanical ventilation and oxygen treatment~     durations in the preterm newborn. Whether surfactant treatment is beneficial for term and~     near term newborns is unknown. The purpose of this study is to compare surfactant treatment~     vs. nasal continuous positive airways pressure in the newborn between 35 and 41 weeks of~     gestation with RDS within the first 24 hours of life. The study's primary endpoint is~     survival with no oxygen treatment at 72 hours of life. The secondary endpoints are: death,~     surfactant treatment, pneumothorax, secondary infections, pulmonary hypertension, inhaled~     nitric oxide treatment, fluid loading treatment, vasopressive amines treatment, mechanical~     ventilation duration, nCPAP treatment duration, Oxygen treatment duration, Oxygen treatment~     at 28 days of life, hospitalization duration and treatment strategy cost.~   "
172577|NCT01306227|"~     Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental~     impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether~     L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.~      The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less~     than 32 WG with THOP.~      The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the~     Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen~     therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock~     requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage,~     retinopathy of prematurity, deafness.~   "
172578|NCT01306214|"~     This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin~     in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of~     insulin in this population would provide significant new information for the BI 10773 use and~     would offer a potential new therapeutic option in this population.~   "
172579|NCT01306201|"~     Data collected from this study will be used to evaluate the performance of a monitoring~     algorithm.~   "
172580|NCT01306188|"~     The T and B cells repertoire diversity represent one of the immune defence level which~     controls the integrity of the organism and determines its ability to recognize and control~     infectious attacks and development of tumours. The study of the lymphocytes TCR and BCR~     diversity could permit to better understand how lymphopenia act on overall survival and to~     improve detection of high risk patients who could benefit of adapted therapies for better~     care.~   "
172581|NCT01306175|"~     The objective of the study is to investigate the relative bioavailability of digoxin after~     concomitant multiple oral administration of BI 10773 and a single dose of digoxin in~     comparison to digoxin given alone to healthy male and female subjects.~   "
172582|NCT01306162|"~     The objective of the study is to assess the relative bioavailability of a single dose of~     dabigatran after concomitant multiple oral administration of dronedarone with the aim to~     investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic~     parameters of dabigatran when administered to healthy subjects~   "
172583|NCT01306149|"~     The aims of this study are~        1. To evaluate the natural history of plasma concentrations and renal and peritoneal~          clearances of small water-soluble uremic retention molecules (URM), 'middle molecules',~          and protein bound URM in incident peritoneal dialysis (PD) patients.~        2. To evaluate the natural history and determinants of the generation rate of URM~          originating from bacterial protein fermentation in PD patients.~        3. To evaluate the natural history of biochemical parameters of mineral metabolism in~          incident PD patients.~   "
172584|NCT01306136|"~     The purpose of this project is to examine the feasibility of a culturally adapted, manual~     based Prolonged Exposure therapy intervention for the treatment of Spanish-speaking Puerto~     Ricans with posttraumatic stress disorder~   "
172585|NCT01306123|"~     The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal~     Spray as compared to an IM injection of cyanocobalamin (European reference product).~   "
172586|NCT01306110|"~     The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers~     in patients with diabetes.~   "
172587|NCT01306097|"~     Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and~     recurrent diarrhea in 6 to 36 months age children in Bandarabbaas~   "
172588|NCT01306084|"~     Background:~      - Viral infections are an important cause of illness and death in hospitalized patients as~     well as outpatients. New strains of viruses may appear and infect both healthy people and~     those with weak immune systems. A better understanding of these new virus strains may help to~     control and prevent these infections. In particular, some viral infections that are less~     problematic in healthy persons can be life threatening in persons with weak immune systems,~     and viruses may be able to evolve more rapidly in persons with weak immune systems and~     therefore develop resistance to existing treatments. Researchers are interested in collecting~     samples and information from otherwise healthy persons or persons with weak immune systems to~     study the effects of viruses and their development.~      Objectives:~      - To collect samples and data from individuals who have been exposed to or have contracted~     viral infections.~      Eligibility:~        -  Individuals of all ages who have been diagnosed with a viral infection are suspected to~          have a viral infection, or have been in close contact with someone with a suspected or~          actual viral infection that is of interest to investigators in the Laboratory of~          Infectious Diseases.~        -  Healthy persons and persons with weak immune systems (immunocompromised individuals) are~          eligible to participate.~      Design:~        -  Participants will be initially screened with a review of the medical records and if~          eligible a history and physical will be performed.~        -  Study procedures may include blood, stool, urine, saliva, or nasal fluid samples, and~          throat and genital swabs. For participants who have a specialized sample collection~          procedure as part of their medical care (e.g., spinal tap, bronchoscopy, liver biopsy),~          researchers may collect leftover samples from the clinical laboratory for testing.~        -  Samples may be collected up to four times per week during the first 2 weeks after~          enrollment in the study, and then as many as two times per week for up to 1 year. The~          number of study visits will be determined by the study researchers, and will depend on~          the virus being studied. Some participants may be asked to continue providing samples~          for longer than 1 year if there is concern for recurrence or relapse of the infection or~          if the study researchers feel that there are other reasons where it would be important~          to follow the viral infection.~        -  For otherwise healthy persons who have been exposed to a viral infection, an initial~          specimen will be collected and then up to three additional specimens may be collected~          over 1 year.~        -  Treatment will not be offered under this study.~   "
172607|NCT01305824|"~     The purpose of this study is to determine if PRT-201 when applied to a limited segment of~     your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous~     fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been~     shown to help keep vessels open (patent) when applied to the outside surface of the blood~     vessels (arteries and veins) in AVF patients in a previous study.~   "
172664|NCT01305083|"~     This randomized, double blind, placebo controlled, multicentric, clinical study will assess~     the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile~     dysfunction(ED).~   "
172589|NCT01306058|"~     Background:~      Sorafenib is a drug that has been approved to treat kidney and liver cancer (hepatocellular~     carcinoma, or HCC) and has been shown to prolong survival in patients with HCC. It works by~     slowing the spread of cancer cells, but it does not fully prevent the cancer from growing~     again. Researchers are interested in combining sorafenib with the experimental drug TRC105,~     which has been designed to block the growth of blood vessels that lead to tumor growth, in~     order to determine whether this drug combination stops tumor growth and reduces tumor size~     better than sorafenib alone.~      Objectives:~      To determine the safety and effectiveness of the combination of sorafenib and TRC105 as a~     treatment for hepatocellular cancer that has not responded to other treatments.~      Eligibility:~      Individuals at least 18 years of age who have been diagnosed with hepatocellular cancer that~     has not responded to other treatments, and who are not considered to be candidates for liver~     transplantation. Patients cannot be receiving anticoagulant therapy with the exception of low~     dose aspirin. No history of bleeding problems or peptic ulcer disease.~      Design:~      Participants will be screened with a full medical history and physical examination, blood and~     urine tests, and tumor imaging studies. Participants will have a tumor biopsy or provide~     previously collected tumor tissue for study. An examination of the esophagus to look for~     problems with blood vessels will be completed in patients with a history of cirrhosis.~      Participants will receive sorafenib tablets twice every day, in the morning and at night,~     with a full glass of water.~      Participants will receive TRC 105 infusions once every two weeks on days 1 and 15 of a 28 day~     cycle.~      At each visit during the first cycle, participants will have a physical examination and blood~     tests. Participants will continue to have blood tests and a urine test every cycle to monitor~     the effects of treatment, including tests of kidney function. Participants will have imaging~     studies after every two cycles to evaluate the results of treatment, and may also provide~     tumor samples for study.~      Treatment will continue as long as the tumor does not grow and side effects remain tolerable.~   "
172590|NCT01306045|"~     Background:~      - The current standard of care for advanced lung cancer and cancers of the thymus consists~     primarily of chemotherapy treatment. The drugs used for chemotherapy depend on the~     classification of the cancer in different categories that are based on the appearance of the~     cancer in the microscope. Though this approach has been proved to be useful in some ways, the~     survival rates of individuals with lung cancer and cancers of the thymus are still very poor.~     Recent research has shown that several genetic abnormalities play an important role in the~     development and growth of lung cancer and cancers of the thymus, and that it is possible to~     improve treatment success rates with drugs that specifically target some of the abnormal~     genes. Researchers are interested in determining whether it is possible to analyze the genes~     of patients with lung cancer and cancers of the thymus in order to provide personalized~     treatment with drugs that target the specific gene abnormalities.~      Objectives:~      - To evaluate the effectiveness of genetic analysis in determining targeted therapy for~     individuals with advanced non-small cell lung cancer, small cell lung cancer, and thymic~     cancer.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with either lung cancer or a~     cancer of the thymus that is not considered to be curable with the use of surgery or~     radiation therapy.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and tumor imaging studies. Participants will have a tumor biopsy~          or provide previously collected tumor tissue for study.~        -  Based on the results of the tumor biopsy study, participants will be separated into~          different treatment groups:~        -  Participants with EGFR gene mutation will receive a drug called erlotinib, which~          inhibits a protein called EGFR that is thought to be a key factor in the development and~          progression of some cancers.~        -  Participants with KRAS, BRAF, HRAS, or NRAF gene mutations will receive a drug called~          AZD6244, which inhibits a protein called MEK that is thought to be a key factor in the~          development and progression of some cancers.~        -  Participants with PIK3CA, AKT, or PTEN gene mutations will receive a drug called~          MK-2206, which inhibits a protein called AKT that is thought to be a key factor in the~          development and progression of some cancers.~        -  Participants with KIT or PDGFRA gene mutations will receive a drug called sunitinib,~          which inhibits some proteins that are thought to be key factors in the development and~          progression of some cancers, including kidney cancer.~        -  Participants who have ERBB2 gene mutation or amplification will receive a drug called~          lapatinib, which inhibits some proteins that are thought to be key factors in the~          development and progression of some cancers, including breast cancer.~        -  Participants who do not have any of the genetic abnormalities described above will be~          offered different options for treatment, including standard of care chemotherapy or~          treatment with investigational agents in a different research protocol.~        -  After 6 weeks of treatment, participants will have imaging studies to evaluate the~          status of their cancer. Treatment will continue as long as participants tolerate the~          drugs and the disease does not progress.~        -  Participants who benefit from the first treatment but eventually develop resistance and~          progression of their cancer will be offered the chance to have a second tumor biopsy and~          undergo a different treatment for their cancer.~   "
172591|NCT01306032|"~     Background:~      - The experimental cancer treatment drug ABT-888 (Veliparib) works by preventing~     deoxyribonucleic acid (DNA) repair in tumor cells. Cyclophosphamide is a cancer treatment~     drug that works by causing DNA damage in cells, including cancer cells, resulting in cell~     death. However, because cyclophosphamide has strong and unpleasant side effects, researchers~     are interested in finding drugs that can be given in combination with cyclophosphamide that~     will allow a lower dose of cyclophosphamide to be given with similar effects. The combination~     of ABT-88 and cyclophosphamide may be an effective treatment for some types of cancer, such~     as certain kinds of breast or ovarian cancer and non-Hodgkin's lymphoma that often do not~     respond to standard therapies.~      Objectives:~      - To evaluate the safety and effectiveness of ABT-888 and cyclophosphamide in ovarian and~     breast cancer and in non-Hodgkin's lymphoma that have not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with (1) (Breast cancer 1/2)~     BRCA1/2 ovarian cancer, primary peritoneal or ovarian high-grade carcinoma, or fallopian tube~     cancer; (2) triple-negative breast cancer (not responsive to hormone-related therapy); or (3)~     low grade non-Hodgkin's lymphoma.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and tumor imaging studies. Participants will be divided into two~          groups with different treatment subgroups.~        -  Group 1: Participants who have BRCA-positive ovarian cancer, primary peritoneal or~          ovarian high-grade serous carcinoma, or fallopian tube cancer~        -  Participants will receive either the combination of ABT-888 and cyclophosphamide, or~          cyclophosphamide alone.~        -  Participants will take the study drug by mouth once a day for 21-day cycles of~          treatment, and will keep a diary to record drug doses and any side effects.~        -  Participants will have clinic visits with blood and urine tests, imaging studies, and~          other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all other~          cycles.~        -  Group 2: Participants who have triple-negative breast cancer or non-Hodgkin's lymphoma~        -  Participants will receive either the combination of ABT-888 and cyclophosphamide, or~          cyclophosphamide alone.~        -  Participants will take the study drug by mouth once a day for 21-day cycles of~          treatment, and will keep a diary to record drug doses and any side effects.~        -  Participants will have clinic visits with blood and urine tests, imaging studies, and~          other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all other~          cycles.~        -  Participants receiving only cyclophosphamide who show signs of disease progression after~          tumor imaging studies can receive the combination of ABT-888 with cyclophosphamide.~        -  Treatment will continue as long as participants tolerate the drugs and the disease does~          not progress.~   "
172592|NCT01306019|"~     Background:~        -  X-linked severe combined immunodeficiency (XSCID) is caused by a genetic abnormality in~          the IL2RG gene that affects the growth and development of immune cells such as white~          blood cells. Individuals with XSCID have difficulty fighting infections, which may lead~          to chronic or severe illness and death. The primary treatment for XSCID is replacement~          of the patient s immune system with a normal immune system through a bone marrow~          transplant. The best outcomes in transplant patients are achieved when the bone marrow~          comes from a sibling, but parents and matching unrelated donors can provide bone marrow~          for transplant as well. However, because these transplant procedures are not always~          effective, researchers are studying gene transfer treatment as an approach to treating~          XSCID.~        -  Lentiviral gene transfer treatment uses good genes to replace defective genes. A~          lentivirus is a virus that has been modified to carry corrected genes into the blood~          through corrected stem cells. By collecting an individual s stem cells and modifying~          them with a lentivirus, the gene-corrected cells can be returned into the blood to help~          produce normal healthy immune cells. Gene transfer treatment with lentivirus vector has~          been used in humans but has never been studied in patients with XSCID.~      Objectives:~      - To determine the safety and effectiveness of lentiviral gene transfer as a treatment for~     children and adolescents with X-linked severe combined immunodeficiency.~      Eligibility:~      - Children and adolescents between 2 and 20 years of age who have XSCID related to a defect~     in the IL2RG gene and who are not currently under treatment with strong immune-modulating or~     chemotherapy drugs.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and bone marrow samples to collect stem cells for the procedure.~        -  Participants will be admitted to the National Institutes of Health Clinical Center 11 to~          12 days before receiving gene-corrected blood stem cells.~        -  Participants will receive palifermin for 3 days, followed by busulfan for 2 days.~          Palifermin will help prevent side effects from busulfan, and busulfan will help suppress~          the immune system in preparation for the gene transfer. Participants will have regular~          blood tests during this preparation period.~        -  Participants will receive a transfer of their corrected blood stem cells about 36 to 48~          hours after the second dose of busulfan. The cells will be injected over 5 to 10 minutes~          under close monitoring.~        -  The day after the transfer, participants will have 3 more days of palifermin.~        -  Participants will remain in the hospital for several weeks, possibly as long as 6 weeks,~          while the response to treatment is monitored.~        -  Participants will continue to be monitored for immune function and possible side effects~          after leaving the hospital, and will be followed for up to 15 years after the procedure~          to evaluate the long-term effects of gene transfer therapy. The monitoring will involve~          regular physical exams and blood samples.~   "
172604|NCT01305863|"~     Researchers are actively seeking a way to coat the inside of a synthetic graft so that it~     more closely resembles native vessels and therefore has low thrombogenicity and low incidence~     of stenosis. Using a biological coating comprised of autologous stromal cells derived from~     the patient's own adipose tissue is a logical solution. Considerable experimental evidence~     exists that such a coating is relatively non-thrombogenic and improves long-term graft~     patency.~      The Company's TGI Cell Isolation System (CIS) for isolating and concentrating adipose-derived~     stromal cells (ASC) can be used to fill the pressing medical need for small-diameter~     synthetic vascular grafts. The TGI CIS enables the user to prepare a stem cell-based~     biological coating from adipose tissue liposuctioned from the patient. The cells derived from~     the adipose tissue are then sodded onto the internal lumen of the vascular graft to improve~     long term patency.~   "
172605|NCT01305850|"~     This is a prospective, randomized, placebo controlled, multi-center clinical trial to~     determine whether aliskiren or aliskiren plus losartan or enalapril plus losartan effects on~     peritoneal membrane transportation.~   "
172593|NCT01306006|"~     The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts~     exclusively on children below 12 months of age; children who have reached 12 months of age~     are no longer entitled to vaccines through the EPI program. This has affected the measles~     vaccination coverage, approx. 30% of the children in the rural area do not receive measles~     vaccine (MV).~      Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on~     survival, reducing mortality by approximately 50% - far more than can be explained by~     prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on~     survival, and the current policy may have important consequences for overall child mortality.~      To test the implications of the current policy of only vaccinating children below 12 months~     of age, the investigators will conduct a cluster randomized trial, in which children will~     receive their vaccines according to the current national EPI policy (National policy) or~     receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy).~      The investigators hypothesise that among children enrolled after 12 months of age, mortality~     is 50% lower in children randomised to receive MV compared with children randomised to follow~     the national policy and not receive MV.~   "
172594|NCT01305993|"~     The purpose of this study is to determine efficacy of SB injection in Gastric Cancer.~   "
172595|NCT01305980|"~     The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.~   "
172596|NCT01305967|"~     The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung~     Cancer.~   "
172597|NCT01305954|"~     The primary purpose of this study is to measure the association between baseline expression~     of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in~     patients with breast cancer. Patients with Stage I-IV breast cancer will be included and~     myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an~     absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study~     subjects will also be asked to complete a brief health behaviors questionnaire to gather~     information on other relevant variables.~   "
172598|NCT01305941|"~     Purpose: This study is a single-arm, open-label phase II clinical trial testing the~     hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective,~     safe, and tolerable among patients with human epidermal growth factor receptor 2~     (HER2)-positive breast cancer brain metastases. Once enrolled, patients will receive~     everolimus PO daily in combination with weekly intravenous (IV) vinorelbine and trastuzumab.~     Cycles will be repeated every 3 weeks (21 days). At the time of progression, patients will~     come off study.~      Participants: Up to 35 adults over 21 with HER-2 positive breast cancer that has metastasized~     to the brain.~   "
172599|NCT01305928|"~     Post-discharge support is a key component of effective treatment for hospitalized smokers,~     but very few hospitals provide it. Linking hospitalized smokers with free, proactive tobacco~     quitlines is an ideal way to provide supportive contact at discharge, because quitlines are~     effective and cost effective for smoking cessation. Many hospitals are beginning to fax-refer~     smokers to quitlines at discharge. Fax referral is convenient and is part of the current~     culture of medical communication channels. However, less than half of fax-referred smokers~     are successfully contacted and enrolled in quitline services. Warm hand-off is a novel~     approach to care transitions in which health care providers directly link patients that have~     substance abuse and mental health problems with specialists, using face-to-face or phone~     transfer. Warm hand-off achieves very high rates of treatment enrollment for these highly~     vulnerable groups.~   "
172600|NCT01305915|"~     As the number of women who survive breast cancer continues to grow, more attention is being~     paid to their quality of life and the disease's long-term effects. The transition from~     patient to survivor, also termed the re-entry transition, can be a very difficult and~     stressful time. A brief psychosocial intervention delivered at this important transition time~     may address the challenges that women face at re-entry, facilitating greater adaptation and~     more optimal recovery. The purpose of the proposed RCT is to test the acceptability and~     effectiveness of a single-session group psychoeducational intervention led by a~     multi-disciplinary team on adjustment to survivorship. A randomized controlled trial design~     (RCT) will be used to recruit 440 women attending the breast clinic at Princess Margaret~     Hospital in Toronto. Participants will be recruited while completing their adjuvant~     radiotherapy and those who agree to participate will complete the baseline questionnaire~     package (T0). They then will be randomized to receive either: (1) standard print material~     (CRL group n=220); or (2) standard print material and a single session group~     psychoeducational intervention (INT group n=220). Two weeks following randomization,~     participants in the CRL group will be given the Getting Back on Track: Life after Treatment~     booklet (current standard care), which includes information on the new health care team,~     physical side-effects, diet and exercise, emotional and social needs and returning to~     everyday life. Participants in the INT group will receive the same booklet and will also~     attend a 2- hour psychoeducational group session facilitated by a multidisciplinary team.~     Participants in both groups will be asked to complete the questionnaire package again at 3~     months (post-1) and 6 -months (post-2) following the completion of cancer treatment.~     Participants in the INV group will also be asked to rate their satisfaction with the class~     and provide feedback on the content. The proposed intervention will be one of the few~     clinical interventions designed to address the service gap in helping women to make the~     transition from patients to survivors by using a single-session psychoeducational group~     intervention.~   "
172601|NCT01305902|"~     The purpose of this pilot study is to estimate the effect size of a contingency management~     procedure that reinforces walking at rates consistent with the American College of Sports~     Medicine recommendations of 10,000 or more steps per day in older adults. We expect that~     participants randomized to the contingency management intervention will increase walking to a~     greater degree than those assigned to a standard care condition.~   "
172602|NCT01305889|"~     The focus of this study is to gather preliminary data regarding the effects of a~     psychological therapy—Problem Solving Therapy—and an antidepressant medication—sertraline—on~     1) cerebral perfusion (CP), 2) brain derived neurotrophic factor (BDNF), and 3) measures of~     cognitive function in subjects with late life major depression (LLMD). This research goal~     will be achieved by recruiting 38 individuals over the age of 65 with LLMD. The primary~     outcomes will be change in CP, change in BDNF, and change in cognitive measures from baseline~     to the end of 12 weeks of either therapy. We will also examine predictors of treatment~     outcome including severity of executive dysfunction, baseline BDNF concentrations, and~     baseline CP measures. The baseline neuropsychological testing, brain imaging, and depression~     assessment will be obtained in a companion study (PI S. Mackin; CHR #H42689-32681-01) that is~     IRB approved and is already in progress. In the current study a baseline serum BDNF level~     will be added to Dr. Mackin's protocol. Patients will then receive either 12 weeks of Problem~     Solving Therapy or antidepressant treatment with sertraline. Both treatments are evidence~     based and commonly administered in our clinic. Outcome variables will be measures of~     depression severity, the BDNF serum concentration, cerebral perfusion using a MRI arterial~     spin labeling (ASL) technique and cognitive changes in memory and executive dysfunction. This~     is a preliminary or pilot study. The primary objectives are to determine if the methods~     appear feasible and to determine if change in BDNF or CP occur after treatment and~     secondarily to determine if there are changes in cognitive functioning. The study is not~     powered to show differences between treatments. The hypotheses are 1) PST will result in~     increased perfusion in frontal regions of the brain but that frontal perfusion will not~     change with sertraline; 2)sertraline will result in an increase in BDNF but PST will not.~     Change in cognitive measures of memory, learning, and executive dysfunction will be examined~     on an exploratory basis.~   "
172608|NCT01305811|"~     This unblinded Phase II clinical trial tested the effects of individualized acupuncture~     treatments offered in extant acupuncture practices in the community; practitioners had at~     least 5 years of experience plus additional training provided by the study. Veterans with~     diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly~     acupuncture treatments (group 1, n=52) or 2 months of waitlist followed by weekly acupuncture~     treatments (group 2, n=52). Measurements were taken at baseline, 2, 4 and 6 months. The~     primary outcome is the SF-36 physical component scale score (SF-36P).~   "
172609|NCT01305798|"~     The goal of this project is to see if behavioral nudges will increase an individual's~     likelihood of participating in a biometric screening. The behavioral nudges under~     consideration are assigning preselected time-slots, encouraging subjects to make an active~     choice, and sending reminders.~   "
172610|NCT01305785|"~     The AMIS Plus national registry collects and analyzes data on patients with acute myocardial~     infarction in Switzerland in the pre-admission, hospital and follow-up phases. Emphasis is~     placed on the evaluation of risk factors, diagnostics, urgent therapy strategies and~     treatment of acute coronary syndrome. The AMIS Plus data gathered are important for assessing~     guidelines, improving compliance with guidelines in clinical practice, investigating patient~     groups not extensively studied in large randomized trials, quality assurance as well as the~     continuous improvement of therapeutic strategies based on a large database.~   "
172611|NCT01305772|"~     The purpose of this study was to identify which cancer-related genes are turned on or turned~     off in order to determine how well a patient will respond to the study drug, panitumumab.~     Panitumumab was added to standard adjuvant or primary radiation therapy. There were subjects~     that receive surgery followed by therapy and subjects that receive radiation therapy without~     surgery.~      Subjects entering this study had locally advanced disease that can be treated with surgery~     and/or radiation therapy. Fresh frozen tumor tissue were available for genomics analysis~     prior to initiating panitumumab therapy. If fresh frozen tissue was not available at time of~     consent, a biopsy was required to participate in this trial.~   "
172612|NCT01305759|"~     The project runs as a Ph.d. project at the Faculty of Health Sciences- University of~     Copenhagen.~      In Denmark the investigators operate around 16.000 artificial hips and knees yearly, mainly~     due to osteoarthritis. The numbers has increased with 13,9% for hips and 50,7% for knees in~     the period 2004 to 2007. In 10% of the cases, or approximately 1.600 patients, the patient is~     younger than 50 years - mid-life, working, socially active and sexually active. The~     investigators have a tendency within in the orthopedic society to mainly focus on the~     technological aspects of the procedure and tend to forget that this is a key event for the~     patient with widespread consequences for the patient and his future life.~      Hip- and knee arthroplasties is without no doubt two of the most important and successfully~     surgical procedures ever introduced. The economical cost for osteoarthritis treatment has~     exploded in the developed world over the last decade, with a yearly growth on 8%.~      Because of the limited lifetime for an artificial hip or knee, this treatment can be~     unfortunate for the young patient. This has over the last years led to an increased interest~     for joint preserving surgery. Over the last twenty years it has been tried to delay the time~     for total hip arthroplasties for patients with hip dysplasia with the aid of Ganz osteotomy.~     Since this technique was introduced back in 1988, the research on the topic has had its main~     focus on optimizing the operation technique. So as with surgery with artificial hip or knee~     the investigators have a lack of knowledge regarding the social, work related, psychological~     and sexual aspects of this treatment.~      Purpose The consequences of an artificial hip or knee joint regarding patients' social-life,~     work, psychological and sexual aspects gain very little attention international. The~     investigators apply most of our research funds exclusively to research and development of the~     surgical track and procedure, new prosthesis designs or coatings. The investigators find this~     study highly relevant because this kind of studies has been preformed for several chronic~     diseases but not osteoarthritis and its treatment.~      With this study the investigators wish to examine the social, work related, psychological and~     sexual aspects of end stage osteoarthritis. This will lead the way for improved information~     to the patient and improve the surgeons' possibilities for chosen the correct time for~     surgery.~   "
172613|NCT01305746|"~     The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.~   "
172614|NCT01305733|"~     The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce~     oxycodone consumption during the first 48 postoperative hours in patients undergoing total~     knee arthroplasty (TKA).~   "
172615|NCT01305720|"~     Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside~     investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique~     the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric~     oxygenation in preterm infants~   "
172616|NCT01305707|"~     OBJECTIVES:~      To evaluate the comparative efficacy and security of Continuation Electroconvulsive Therapy~     associated with pharmacotherapy versus pharmacotherapy alone in the prevention of depressive~     relapse.~      METHODS:~      Demographic and clinical variables will be collected and side effects scales and~     neurocognitive battery will be performed. Variables of efficacy: relapse percentage in both~     groups in one year (primary variable); time without relapse. Main variable of security:~     occurrence of side effects and neurocognitive performance.~      DESIGN: Randomized controlled clinical trial.~      SAMPLE:~      104 outpatients diagnosed with unipolar depression (DSM-IV-R criteria) who had remitted with~     a course of bilateral ECT. They will be randomized to two groups of treatment.~      SETTING: Psychiatry Department at Bellvitge University Hospital.~      ANALYSIS: Descriptive analysis of clinical variables; survive analysis and Cox model of~     regression.~   "
172617|NCT01305694|"~     The study is a phase I/II trial designed to establish the safety and efficacy of intravenous~     administration of bone marrow derived mesenchymal stem cells from related donor to patients~     with relapsed/refractory aplastic anemia.~   "
172618|NCT01305681|"~     The primary objective of our study is to examine characteristics of bacteria that are~     discovered in urine from pediatric patients that utilize either LoFric® or non-LoFric®~     catheters for self intermittent catheterization. The investigators hypothesize that the~     hydrophilic nature of the LoFric® catheter will alter the microbial environment and reduce~     clinically significant urinary tract infections in patients with neurogenic bladder compared~     to a similar population using standard catheters.~      Secondary outcomes will be comparing the incidence of clinical urinary tract infections~     between patients that use standard catheters and those that use LoFric catheters.~      Lastly, patient satisfaction using LoFric catheters compared to standard catheters will be~     assessed.~   "
172619|NCT01305668|"~     Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis~     and pulmonary emphysema phenotypes) with a different clinical presentation.~      The phenotype evaluation in COPD patient (trough clinical, functional and radiographic~     parameters) could influence final results in pharmacologic and non-pharmacologic management~     of the disease.~      The aim of our study is to investigate whether COPD patients with different disease phenotype~     (chronic bronchitis versus pulmonary emphysema) have a different response to PR.~   "
172622|NCT01305629|"~     The proposed study uses a randomized controlled experimental design to evaluate the efficacy~     of a brief intervention using spiritual self schema (3S+) counseling to simultaneously target~     HIV health outcomes, and substance use among alcohol and/or drug dependent HIV positive older~     adults (age 50+), relative to an attention control condition. Participants will be randomly~     assigned to receive either: (1) 12 sessions of 3S+ counseling, adapted for the present study~     to target both non-injection drug use, drinking, and HIV health; or (2) 12 sessions of~     education about HIV health and the associated with alcohol and drug use that will serve as an~     attention-control.~   "
172623|NCT01305616|"~     To investigate the effect of yellow-tinted IOLs on the Short Wave-length Automated Perimetry~     (SWAP) and Standard Automated Perimetry (SAP) in patients with and without glaucoma.~   "
172624|NCT01305603|"~     Using Magnetic resonance (MR) scanning and ultrasonography the investigators wish to~     investigate, in what way a known volume of local anesthetic injectate will be distributed in~     the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators~     compare the anatomical distribution of the local anesthetic injectate in the TAP when~     performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators~     also want to compare the spread of anesthetized frontal dermatomes when performing an~     ultrasound-guided classical TAP block and a Dual TAP block.~   "
172625|NCT01305590|"~     In anticipation of a pilot study incorporating behavioral economics into the treatment of~     infectious diseases, we will conduct a survey with HIV/AIDS patients at the Ponce Clinic~     (Infectious Disease Program of Grady Memorial Hospital, Emory University School of Medicine,~     Atlanta, GA).~   "
172626|NCT01305577|"~     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of~     submental fat (fat below the chin).~   "
172627|NCT01305564|"~     The Bard® Denali™ Retrievable Inferior Vena Cava (IVC) study is a prospective, multi-center~     study which is intended to provide evidence of safety of the placement and retrieval of the~     Bard® Denali™ Retrievable Inferior Vena Cava Filter in subjects requiring IVC interruption to~     protect against pulmonary embolism (PE).~   "
172628|NCT01305551|"~     The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and~     Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (XR) fixed dose~     combination (FDC) tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil~     by Merck S.A.) tablets administered together in both the fasted and fed states.~   "
172629|NCT01305538|"~     The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared~     to placebo in the treatment of patients with post-herpetic neuralgia (PHN).~   "
172630|NCT01305525|"~     This is a prospective non-interventional 24 month post implant registry. Any patient that~     receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for~     enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites.~      Patients will be enrolled post-implant and followed for 24 months. Data are collected at~     enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months,~     6 months, 12 months, 18 months and 24 months.~   "
172631|NCT01305512|"~     Evaluation of pharmacokinetic profile of SPARC1028~   "
172632|NCT01305499|"~     This research is being done to help us learn how to best use new drugs which may be active~     against acute myeloid leukemia (AML). Two study drugs will be tested: 5AC (5-azacitidine) and~     entinostat. 5AC improves blood counts in 50 - 60% of patients with MDS and has also shown~     promise in AML. Entinostat has undergone early testing in patients with MDS and AML. It has~     decreased the blast count in some patients' blood and bone marrow and has improved the blood~     counts in some patients. The combinations of these two classes of drugs are well tolerated~     and appear to work well together in laboratory tests.~      A recent study at Johns Hopkins University administered 5AC and entinostat in an overlapping~     schedule to patients with myelodysplastic syndrome (MDS), Chronic myelomonocytic leukemia~     (CMMoL), and AML. The impressive results from this study have led to another phase II trial~     to further examine this drug combination versus 5AC alone in these patients. In this study,~     we want to see how the timing of when 5AC and entinostat are given affects the magnitude of~     the disease response.~   "
172633|NCT01305486|"~     This will be an observational study designed to collect early, short- and long-term clinical~     outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be~     expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.~   "
172634|NCT01305473|"~     This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing~     Sepramesh at least 12 months before starting in this study.~      The consented subjects' medical records will be reviewed for evidence of any risk factors of~     hernia recurrence, procedure time, complications and any documented recurrences. The subjects~     will be asked to undergo a physical exam to rule out any recurrences that were not documented~     in the medical records.~   "
172635|NCT01305460|"~     A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine~     (Vidaza®) in intermediate-2 and high risk MDS patients.~   "
172636|NCT01305447|"~     Adult female smokers will participate in an exercise-aided smoking cessation program, and~     will then be randomized into one of four cessation maintenance conditions: (a) Exercise~     Maintenance only (b) Exercise Maintenance + Relapse Prevention Booklets(c) Relapse Prevention~     Booklets + Contact and (d) Contact Control. Primary follow-up outcome is smoking behaviour.~     Secondary outcomes include exercise behaviour, Physiological measures (body composition~     (Dual-emission X-ray absorptiometry; DXA), vascular health (stiffness, endothelial function,~     carotid plaque volume), physical fitness), and Psychological measures (self-regulatory~     cognitions related to exercise adherence [exercise, scheduling, barrier, relapse, and~     concurrent self-regulatory self-efficacy]).~      The hypotheses detailed below are specific to the randomization of participants into the~     following 4 groups:~        1. Exercise Maintenance only~        2. Exercise Maintenance + Relapse Prevention Booklets~        3. Relapse Prevention Booklets + Contact~        4. Contact Control~      Hypothesis 1: Compared to quitters in the contact control condition, quitters exposed to a~     home-based lifestyle exercise maintenance intervention (Exercise Maintenance only and~     Exercise Maintenance + Relapse Prevention Booklets) will demonstrate significantly greater~     exercise adherence and fitness levels, as well as significantly less weight gain and smoking~     relapse rates following exercise-aided smoking cessation program termination.~      Hypothesis 2: Compared to quitters in the contact control condition, quitters exposed to~     relapse information only (Relapse Prevention Booklets + Contact) will experience~     significantly less smoking relapse following exercise-aided smoking cessation program~     termination.~      Due to the novelty and exploratory nature of the respective prevention programs, no~     hypotheses are specified with respect to which prevention program (exercise maintenance or~     relapse prevention information) will be superior to the other, or whether the additive~     benefits (i.e., exercise maintenance plus relapse prevention information) will be superior to~     one prevention program alone.~   "
172637|NCT01305434|"~     Mulberry leaf teas or extracts are used as a natural remedy for diabetes in some countries.~     Animal studies have shown some effect of mulberry leaf extract on blood glucose. The purpose~     of this trial is to assess the effect of mulberry leaf extract on type 2 diabetics, by~     measuring blood glucose two hours after eating a meal and taking a capsule containing either~     mulberry leaf extract or a placebo.~   "
172640|NCT01305395|"~     1. Early initiation of sirolimus will prevent or delay the development of intimal~          thickening and subsequent graft failure.~        2. Treatment guided by the development of cardiac allograft vasculopathy (CAV) on~          intravascular ultrasound (IVUS) will be more effective in delaying progression of CAV~          compared to treatment guided by angiography.~        3. Prevention of the development and progression of intimal thickness on IVUS will prevent~          the development of heart failure, graft dysfunction, and cardiovascular death related to~          CAV.~        4. Small artery elasticity predicts progression of cardiac allograft vasculopathy and is~          modified by sirolimus~        5. Patients who have no progression of CAV will have favorable improvement in biomarkers~          and endothelial cells compared to patients who have progression of CAV~   "
172641|NCT01305382|"~     Abnormal peripheral endothelial function and alterations in circulating biomarkers that are~     associated with endothelial activation and inflammation correlate with angiographic evidence~     of cardiac allograft vasculopathy, defined as greater than 25% stenosis in a major coronary~     artery.~   "
172642|NCT01305369|"~     Cysteinyl leukotrienes (cys-LTs) are lipid inflammatory mediators that abound in mucosal~     inflammation and play a validated role in the pathogenesis of human asthma. It has recently~     been demonstrated that the platelet adenosine diphosphate (ADP) receptor, P2Y12, is required~     for LT4-mediated pulmonary inflammation and could be a novel potential therapeutic target for~     asthma. Thienopyridines (such as ticlopidine and clopidogrel) are pro-drugs, with proven~     antithrombotic efficacy, whose active metabolites selectively inhibit the platelet P2Y12~     receptors. One of the drawbacks of thienopyridines is the high inter-individual variability~     in pharmacological response, mostly due to the high inter-individual variability in the~     capacity of transforming the pro-drug in its active metabolite. Prasugrel is a new member of~     the class of thienopyridines, with faster onset of action and a more uniform inhibition of~     platelet function compared to the other thienopyridines. Primary objective of our study will~     be to test whether or not the inhibition of the platelet P2Y12 receptor by prasugrel reduces~     the bronchial hyper-reactivity in patients with chronic asthma. The investigators designed a~     randomized, double blind (Subject, Caregiver, Investigator, Outcomes Assessor), crossover,~     placebo-controlled, prospective study, which will enroll 26 patients. Randomization will be~     performed in sequential blocks. Patients will be blindly and randomly allocated to treatment~     A (prasugrel 10 mg daily) or B (placebo) for 15 days. After a 15-day wash-out period,~     patients who had initially been allocated to treatment A will be allocated to treatment~     B, and vice versa. Measurements will be done at baseline and on day 15 after each~     treatment, at the same time (+/- 1 h) of the day. Primary efficacy measure will be changes in~     airway hyper-responsiveness, recorded as reduction of FEV1 using the mannitol test induction.~     Secondary efficacy measures will be changes in markers of airway inflammation in sputum,~     changes in measurement of nitric oxide expiration (as surrogate marker of airway lung~     inflammation), count of eosinophil granulocytes in peripheral blood smear, changes in asthma~     exacerbation rates and symptom scores. Changes in phosphorylation of platelet VASP~     (Vasodilator-stimulated phosphoprotein) by ADP, measured with a flow cytometric technique,~     will be used as markers of the degree of inhibition of platelet P2Y12 receptors attained in~     each subjects by treatment with prasugrel.~   "
172643|NCT01305356|"~     STUDY OBJECTIVES:~      To demonstrate equivalent clinical and radiologic outcomes as gold standard (Autologous~     Bone Graft) in a representative clinical model (hindfoot fusions)~      STUDY HYPOTHESIS:~      Augment™ Injectable is an equivalent bone grafting substitute to autologous bone graft in~     applications as shown by superiority analysis for safety and non-inferiority analysis for~     effectiveness~      STUDY RATIONALE:~      To evaluate a fully synthetic bone graft material to facilitate fusion in conditions or~     injuries requiring bone graft in a representative clinical fusion model and thus the~     opportunity to provide equivalent union rates as Autologous Bone Graft without necessitating~     an additional invasive procedure to harvest the graft~   "
172644|NCT01305343|"~     240 subjects with high risk adult spinal deformity requiring surgical correction will be~     enrolled in a prospective multi-center international study. High risk patients are defined~     by either their diagnoses and/or the type of surgical intervention as listed in the inclusion~     criteria. Neurologic complications in the form of new motor and sensory deficits will be~     monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six~     months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be~     adjudicated for relationship to the surgical intervention.~      Regression analyses will be used to evaluate the association between patient demographics, co~     morbidities, treatment history, spinal deformity characteristics, surgical characteristics,~     non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit~     after surgery.~   "
172645|NCT01305330|"~     There is a rising incidence of incidentally detected small renal tumours due to improved~     imaging techniques. Traditionally, patients diagnosed with these small renal masses undergo~     surgery and therefore there is limited data about the natural history of these tumours.~     Several small series have reported that most of these small masses grow slowly and might not~     require early intervention and that only some masses grow rapidly requiring immediate~     surgery. Presently, the investigators have not been able to identify prospectively which~     masses are going to grow slowly. The investigators plan to use computed tomography (CT) and~     Magnetic Resonance Imaging (MRI) parameters, microsatellite analysis and tissue analysis to~     determine which masses will behave more aggressively. Additionally, the observations on the~     natural history of small renal masses need to be validated with a multicentric and~     systematically followed cohort.~   "
172646|NCT01305317|"~     This is double blind randomized controlled trial on the statins effects on serum IgG, IgA and~     IgM level in chronic hemodialysis patients in Bandarabbas~   "
172647|NCT01305304|"~     Until now it has been assumed that regular endurance training has a positive influence on~     cardiac function and that the positive effect increases with increasing intensity. However,~     little is known about the effects of intense endurance stress on the heart. According to~     current knowledge repeated exposure to strenuous endurance activity may lead to minor but~     possibly irreversible damage to the heart with resultant scarring of the heart's muscle.~      Within this study the investigators attempt to find out by different analytical methods - in~     particular magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the~     heart muscle is affected by long term intense endurance exercise and which changes in cardiac~     function and morphology can possibly be found. Therefore the investigators compare former~     national competitive endurance athletes with sedentary controls.~   "
172648|NCT01305291|"~     Emerging research suggests fiber, particularly digestion-resistant maltodextrins such as~     Fibersol-2, may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing~     satiety signals from the gut. This research aims to determine whether or not Fibersol-2 may~     impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals~     from the gut.~   "
172665|NCT01305070|"~     Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or~     in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon~     (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).~   "
172649|NCT01305278|"~     Patients with a unilateral vestibular loss often complain of dizziness and imbalance.~     Movement usually increases these symptoms often resulting in patients avoiding these~     movements, causing further limitations in their activities of daily living. Vestibular~     Rehabilitation (VR) involves a series of adaptation and balance exercises to improve symptoms~     of postural stability. There is evidence that stroke patients gain benefit in their~     rehabilitation from using gaming consoles (Nintendo Wii Balance) and we believe that similar~     advantages can be shown for balance patients. We plan a 3 arm study. As there is a~     considerable wait list for VR, the first arm will receive a Wii console and instructions to~     use it on the wait list and during VR. The second arm will receive a Wii console and~     instructions at the end of the waiting list and will use it during VR only and the control~     group will receive no Wii. All will spend the same time on the wait list and will receive~     identical assessments and VR~   "
172650|NCT01305265|"~     The purpose of this study is to test whether the incidence of sore throat and other tracheal~     co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at~     the beginning of surgery to inflate to the proper pressure compared to the standard~     technique.~      The investigators hypothesis is that inflation of the endotracheal balloon using a cuff~     manometer immediately after intubation will reduce the incidence of sore throat and other~     tracheal co-morbidities.~   "
172651|NCT01305252|"~     The Study Hypothesis:~      Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a~     traditional step-up approach.~      The study will evaluate:~        1. Impact of dual, upfront, therapy on cardiovascular parameters in PAH as gauged by~          cardiac magnetic resonance imaging (cMRI) at 24 weeks and event free survival at outcome~          at 48 weeks.~        2. Value of novel biomarkers (NT-pro BNP, Mts1/S100A4, and insulin resistance) and~          cutting-edge imaging technologies (cardiac MRI) as newer endpoints for clinical trials~          in PAH.~        3. Utility of longer clinical trial design with the use of combined clinical events as time~          to clinical worsening surrogate~   "
172652|NCT01305239|"~     Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which it~     is used in clinical practice in France (as adjuvant endocrine therapy).~   "
172653|NCT01305226|"~     This novel fibrinolytic agent is a 136 amino acid single chain protein secreted by some~     strains of Staphylococcus aureus and readily produced by recombinant DNA technology. Two~     natural variants of recombinant staphylokinase, THR-100 and SakSTAR, have been developed for~     investigational use in preliminary trials. Like SK, it forms an equimolar complex with~     plasmin which in turn activates plasminogen to plasmin. Unlike SK, the complexed, activated~     molecule (which undergoes proteolytic cleavage of the first ten amino acids to generate~     active staphylokinase) has a high degree of fibrin-selectivity in a human plasma milieu. This~     fibrin-selectivity is due in large measure to potent activation at the clot surface by trace~     amounts of plasmin, and rapid inactivation of the circulating complex by antiplasmin. Hence,~     it provides an interesting and promising alternative therapy.~   "
172654|NCT01305213|"~     This randomized phase II trial studies how well bevacizumab with or without fosbretabulin~     tromethamine works in treating patients with ovarian epithelial, fallopian tube, or~     peritoneal cavity cancer that has come back or is persistent. Monoclonal antibodies, such as~     bevacizumab, find tumor cells and help kill them. Bevacizumab and fosbretabulin tromethamine~     may stop the growth of ovarian cancer by blocking blood flow to the tumor. It is not yet~     known whether bevacizumab is more effective with or without fosbretabulin tromethamine in~     treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.~   "
172655|NCT01305200|"~     This randomized phase III trial is studying how well Caphosol rinse works in preventing~     mucositis in young patients undergoing autologous or donor stem cell transplant.~     Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth~     sores, in patients undergoing stem cell transplant.~   "
172656|NCT01305187|"~     This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3~     in the treatment of nasolabial folds~   "
172657|NCT01305174|"~     The objective of this prospective, randomized,controlled and multicenter trial is, to compare~     recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the~     selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of~     common and external iliac artery disease.~   "
172658|NCT01305161|"~     To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to~     neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which~     may be used for an ulterior anaesthesia in case of allergy to one given NMB.~   "
172659|NCT01305148|"~     The WARFARIN Study is a clinical trial designed to determine if the use of genetic~     information related to warfarin sensitivity can help create a dose of warfarin that will~     result in less hospitalizations and deaths related to warfarin.~   "
172660|NCT01305135|"~     Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the~     FDA/EMEA approved Schedule and dosing.~      For the Phase I study :~      Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine~     in patients with INT-2 or higher risk MDS.~      For the phase II study:~      Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000~     criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher~     risk MDS~   "
172661|NCT01305122|"~     This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II~     glioma will be followed during 5 years.~        -  cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy)~        -  cohort B: patients with disease simple monitoring.~      The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive~     functions and quality of life, using validate and standard tests.~   "
172662|NCT01305109|"~     The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary~     objective of evaluating the efficacy of three doses of ORV 116E, 10^5.0 FFU, against severe~     rotavirus gastroenteritis, in comparison with a placebo in India.~   "
172663|NCT01305096|"~     The purpose of this study is to determine whether inversions (specific yoga postures in which~     the heart is higher than the head) and other dynamic and static yoga postures affect heart~     rate variability, oxygen uptake, blood pressure, blood parameters and other objective~     measures of health, and a variety of subjective and objective measures of health in female~     and male individuals in Sweden.~   "
172666|NCT01305057|"~     The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates~     filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined.~     Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated~     with P-IP formulation on one side of the face and with a placebo formulation on the other~     side twice daily (morning and evening) for 28 days. All subjects gave written informed~     consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were~     evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S.~     ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.~   "
172667|NCT01305044|"~     Persons over age 65 years constitute a large and growing population of cancer survivors.~     Available data indicate that both short- and long-term female breast cancer survivors report~     more limitations related to strength and mobility than women with cancers of other sites and~     women without a personal history of cancer. Further, better mental health among breast cancer~     survivors has been shown to protect against physical decline and overall quality of life. The~     combination of mental and physical interventions may result in substantial improvements in~     quality of life. Tai Chi Chih (TCC), a form of mind-body exercise, is one such intervention.~     TCC may be particularly suited toward elderly breast cancer survivors with impaired physical~     and/or mental functioning, yet despite its increasing popularity and benefits in healthy and~     diseased populations, its benefits have never been scientifically evaluated in this~     population. The overarching goal of this study is to conduct preparatory work regarding the~     effects of TCC on quality of life and physical function that will underpin future definitive~     trials of TCC in elderly cancer survivors. As part of this 12-week trial, participants will~     be randomized to a TCC or a health education control group (HEC). Establishment of meaningful~     interventions that facilitate a more positive cancer survival experience in old age is an~     important issue; there are substantial public health and clinical benefits should a TC~     intervention be successful in this patient population.~   "
172668|NCT01305031|"~     In this randomized control trial, the investigators hypothesize that late-preterm infants~     resuscitated with a low oxygen delivery strategy (initiation of resuscitation with room~     air) will result in a significant reduction in oxidant stress without any harmful clinical~     effects.~   "
172669|NCT01305018|"~     This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation~     on resistance exercise-induced muscle damage and inflammation.~   "
172670|NCT01305005|"~     -  To investigate ocular haemodynamics after phacoemulsification surgery~        -  To evaluate the influence in people with different autoregulation of ocular blood flow~   "
172671|NCT01304992|"~     The objective of the study is to determine the efficacy of lupin protein drinks (Lupinus~     angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the~     metabolism of proteins, lipids and cholesterol will be evaluated.~   "
172672|NCT01304979|"~     Acupuncture has been studied in the perioperative setting and shown to reduce pain, anxiety,~     nausea and vomiting. Studies have been conducted in orthopedic surgery patients, but not~     spine patients. The investigators study will look at a combination of acupuncture therapies~     for patients having low back spine fusions to assess pain levels and return to function.~      114 subjects will be randomized into a direct acupuncture therapy group (38), an indirect~     acupuncture therapy group (38), or usual care alone (38). All subjects will receive usual~     care for spine fusion patients.~      Direct acupuncture therapy subjects will have pre-op auricular seeds in four distinct ear~     points bilaterally, an acupuncture treatment on the day after surgery and an acupuncture~     treatment with gua sha on the 2nd day after surgery (typically day of discharge).~      The indirect acupuncture therapy group will have treatment timed exactly as the direct~     intervention group but consist of 'indirect' treatment: tape placed at ear points at pre-op,~     ear seeds placed on several body points on the first and second day after surgery.~      BPI, VAS, SPF36-2, and ODI measures will be taken at enrollment and at the 4-6 week follow-up~     appointment with subjects' spine surgeon. BPI and VAS will also be taken at day 3 and day~     7-10 additionally.~   "
172673|NCT01304966|"~     The purpose of the present study was to identify risk factors for more severe juvenile~     Recurrent Respiratory Papillomatosis (RRP) through prospective evaluation of a pediatric~     population in Thailand by the employing a protocol that includes staging of disease severity~     using above mentioned staging system at the time of each endoscopic debridement, as well as~     human papilloma virus (HPV) genotyping.~   "
172674|NCT01304953|"~     The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several~     animal models. However, studies in human volunteers have not been reported except for one~     recent study suggesting that ondansetron could alleviate propofol-induced nociception.~     Previous studies demonstrated that patients anaesthetized with sevoflurane have more pain~     than those anaesthetized with propofol. And we further posit that the difference is due to~     the nociceptive processing induced by the action of 5-HT3A receptors.~      In this prospective, randomized, double-blind, placebo-controlled study, we assessed the~     analgesic action of a 5-HT3A receptor antagonist (tropisetron) in women after gynaecological~     laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.~   "
172675|NCT01304940|"~     The purpose of this study is to examine the relationship between trauma and startle. The~     investigators are also looking at the effect of menstrual phase on this relationship.~   "
172687|NCT01304784|"~     This study is an open-label, dose-escalation study of MM-111 with five different combination~     treatments with the main goal of determining the safety of MM-111 with each combination.~   "
172688|NCT01304771|"~     Probiotics are viable commensal microorganisms that promote the establishment of beneficial~     microflora. Animal and human studies demonstrate that probiotics can enhance body's immune~     response to stimuli. Mayo Clinic in conjunction with Agri-King Corporation has developed a~     novel synbiotic called AKSB (Agri-King Synbiotic) that contains a probiotic bacterium~     (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast~     (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide~     [FOS], NutraFlora®). This phase I placebo-controlled trial of AKSB in normal human~     volunteers, over 65 years of age, is designed to study the safety of this probiotic when~     patients are also receiving an influenza vaccine. If this study shows that AKSB is safe then~     our aim is to do a larger study to see if we can improve influenza vaccine immune response~     while taking the probiotic compared to placebo.~   "
172676|NCT01304927|"~     Today, it is evident that vitamin D (VD) has more widespread effects than the classical~     actions related to bone mineralization and calcium homeostasis1. VD deficiency results in~     impaired reproductive performance in various species of animals, and recently the~     investigators have shown that the VD receptor (VDR), activating (CYP2R1, CYP27A1, CYP27B1)~     and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis, seminal~     vesicle, prostate and spermatozoa. Our following functional studies showed that VD increases~     intracellular calcium in mature spermatozoa, and hence may be important not only for~     spermatogenesis but also for sperm maturation. A new, and yet unpublished cross sectional~     study of 300 young healthy Danish men showed that men with lower levels of serum VD have~     significantly lower number of normally developed and motile spermatozoa. Hitherto, most cases~     of male infertility have been classified as idiopathic, and infertile couples have been~     referred to symptomatic treatment at infertility clinics. These fertility treatments are~     often physically demanding for the female partner as well as expensive for the health care~     system. Any treatment that might improve semen quality of involuntary infertile men would be~     beneficial both for the infertile couples and the society in general. Our findings that VD~     may play a role for human semen quality have not yet been tested clinically. However, if VD~     supplementation proves efficient this opens for the first time for a causal, safe and cheap~     treatment of at least some cases of idiopathic impaired semen quality. The investigators~     believe our new human data supported by the results from the VD deficient and VDR KO animal~     studies and the high proportion of VD deficient Danish men provide sufficient evidence to~     initiate a randomized clinical trial of VD supplementation to infertile men. Infertile men~     have also have unfavorable altered levels of sex hormones and higher mortality than fertile~     men. Since VD deficiency is associated with increased mortality, regulation of aromatase,~     immune system, bone metabolism, glucose metabolism, cardiovascular system etc. our suggested~     clinical trial may also be able to evaluate several secondary endpoints in addition to the~     potential effect on semen quality.~   "
172677|NCT01304914|"~     In this study, the investigator will be approaching pregnant women to undertake 2 years of~     weekly respiratory and nappy specimen collection from their healthy new born infant. These~     specimens will be mailed to the Queensland Paediatric Infectious Diseases (Qpid) Laboratory~     where they will be stored and batched tested for viruses and bacteria. As well as this,~     parents will keep a simple daily symptom diary for their child, allowing us to match~     detection of viruses and bacteria to periods when the study child did or did not have~     symptoms. This will help our understanding of what finding these viruses and bacteria in~     specimens from children really means.~   "
172678|NCT01304901|"~     The purpose of this study is to determine if adding single dose of oral montelukast to the~     standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment~     of acute wheezing provide additional clinical benefit in the emergency room.~   "
172679|NCT01304888|"~     The Programa de Apoyo Alimentaria (PAL) started in 2003 and is targeted to communities in~     Mexico that do not receive benefits from other federal food aid programs, have less than~     2,500 inhabitants and a high level of marginalization. Marginalization is a term used in~     Mexico for the multidimensional assessment of poverty in a community.~      When the program started in 2003 it provided beneficiary households either a cash transfer of~     150 Mexican pesos (equivalent to approximately 14 USD at the time) per month or a monthly~     food basket with a cost to the program of 150 pesos. The size of the cash transfer and the~     amount of food was the same for all households, i.e. no adjustments for family size or~     composition were made. The basket contained a number of staple and basic food products and~     powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate (Table~     1). The composition of the food basket conformed to the Mexican norm for food aid programs~     (NOM-169-SSA1-1998), which states that food transfers need to provide at least 20% of the~     recommended daily energy and protein requirements. Beneficiary households were required to~     attend nutrition and health education sessions and had to participate in program related~     logistic activities in order to receive the benefits. These program conditionalities,~     however, were not strictly enforced.~      A community randomized controlled intervention trial was used to evaluate the impact of the~     intervention. A random sample of 208 rural communities was drawn from the pool of eligible~     communities in 8 of the poorest states in the South/Eastern region of Mexico (Chiapas,~     Guerrero, Oaxaca, Quintana Roo, Tabasco, Campeche, Yucatan and Veracruz). Within each~     community a random sample of 33 households was selected. The baseline survey was conducted~     from October 2003 to April 2004. After baseline data collection, the 208 selected communities~     (6,687 households) randomly assigned to one of four study groups: food basket without~     education (52 communities, 1657 households), food basket with education (52 communities, 1680~     households), cash transfer with education (53 communities, 1687 communities) or control (51~     communities, 1663 households). Treatment allocation was carried out by the Ministry of Social~     Development.~   "
172680|NCT01304875|"~     When to start children with Fabry disease on therapy is controversial because of its expense~     and inconvenience. Many Fabry children complain of exercise intolerance. In adults, the~     investigators have found decreased lung function and ability to exercise on a treadmill.~     Whether or not lung function and exercise capacity is abnormal in children is unknown. While~     lung function and exercise tests are commonly part of routine evaluations for adults with~     Fabry, they are not yet for children.~      The objective of the proposed study is to more accurately define the lung and exercise~     abnormalities in a group of 20 boys from 8-18 years of age with Fabry disease who have not~     been treated with enzyme replacement therapy (Fabrazyme).~   "
172681|NCT01304862|"~     The purpose of this study is to determine whether mental health treatment disengagement may~     be mitigated by reducing barriers to self-management and enhancing self-management skills.~   "
172682|NCT01304849|"~     The current standard treatment for advanced Hodgkin's lymphoma 6-8 cycles of ABVD~     chemotherapy-this cures 70-80% patients. Those not cured after 8 cycles of ABVD have a poor~     outcome (<10% survival). More intensive chemotherapy like Escalated BEACOPP (EB) achieve~     higher cure rates have more side effects. Hence the investigators propose to use Interim PET~     CT scan (done after 2 cycles of ABVD) for early identification of poor responders (it is~     known that those with interim PET positive disease have a cure rate of less than 10-15% if~     continued with ABVD alone) and to use EB selectively in this population in an attempt to~     improve treatment outcomes - at the same time to limit side effects of therapy.~      Thus, this study is an attempt to improve the outcome in the small subset of poor responders~     to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy~   "
172683|NCT01304836|"~     The purpose of this study is to focus on potential differences in the occurrence of new-onset~     Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of~     immunosuppressive treatment are compared.~   "
172684|NCT01304823|"~     The purpose of this study is to determine the functional significance of sweet taste~     receptors in the secretion of GI satiation peptides by using a specific sweet taste receptor~     antagonist to block sweet taste perception in the gastrointestinal tract.~   "
172685|NCT01304810|"~     The purpose of the study is to obtain two year follow up data for subjects that received six~     vaccinations of NicVAX in prior phase III studies. No treatment will be administered.~     Anti-nicotine antibody levels and safety data will be collected.~   "
172686|NCT01304797|"~     This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a 3+3~     design. Successive cohorts of three or more patients will be treated at escalating doses~     until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified,~     an Expansion Cohort will be enrolled at that dose to further characterize safety and~     pharmacologic endpoints. Additional arms will be enrolled to explore the combination of~     MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2~     positive breast cancer.~   "
172689|NCT01304758|"~     The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided~     focused ultrasound thermal ablation of a designated area in the brain of patients suffering~     from medication-refractory Essential Tremor, using the ExAblate transcranial system.~      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI~     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the~     targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion~     created in the ventralis intermedius nucleus of the thalamus.~      The treatment begins with a series of standard diagnostic MR images to identify the location~     and shape of tumor to be treated. The ExAblate computer uses the physician's designation of~     the target volume to plan the best way to cover the target volume with small spots called~     sonications. These treatment spots are cylinder shaped. Their size depends on sonication~     power and duration. During the treatment, a specific MR scan, which can be processed to~     identify changes in tissue temperature, provides a thermal map of the treatment volume to~     confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,~     and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.~      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing~     1000-element phased array transducer) positioned above the subject head. The ExAblate~     transcranial system also includes means to immobilize the subject head, cool the interface~     water, and software for CT analysis and phase correction computation.~      The ExAblate transcranial system is an experimental device and is being investigated in this~     study.~   "
172690|NCT01304745|"~     The purpose of the study is to evaluate and compare the effect of: 1 Educational and~     counselling in groups, 2) Physical training in group with 3) Control group, on global- and~     health related quality of life and coping in patients finished treatment for gynaecological~     cancer.~   "
172691|NCT01304732|"~     This is a retrospective analysis of infection on catheters of pediatric oncology patients.~   "
172692|NCT01304719|"~     The current protocol aims to examine the effects of a computer-based intervention used in~     conjunction with existing Healthy Families America (HFA) home visitation programs on the~     challenges related to participant enrollment, retention, and motivation as well as parent and~     child outcomes.~   "
172693|NCT01304706|"~     This study will assess the safety and utility of the new inserter for the administration of~     ILUVIEN in subjects with diabetic macular edema.~   "
172694|NCT01304693|"~     The purpose of this study was to assess the safety, tolerability, and the effects of~     treatment on ocular outcomes following a single intravitreal administration of ESBA1008~     compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).~   "
172695|NCT01304680|"~     Retrospective study to evaluate the characteristics of patients and of fluid resuscitation~     during intensive care unit hospitalization of patients under septic chock.~   "
172696|NCT01304667|"~     This retrospective, multicenter study is designed to collect tumor characteristics as well as~     treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the~     vulva with emphasis on indication and application of radio- and chemotherapy. Application of~     chemotherapy in primary treatment of vulvar cancer is rare; the study collective is therefore~     extended to relapsed disease.~   "
172697|NCT01304654|"~     Identify pediatric oncologic patients with ALI/ARDS at GRAACC/IOP's Pediatric Intensive Care~     Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.~   "
172698|NCT01304641|"~     The purpose of this study is to compare rates and risk of primary cardiovascular events among~     elderly patients newly initiating therapy with atorvastatin or simvastatin. The specific~     objectives for this project are to: 1) examine the demographic and clinical characteristics~     of the elderly patients in whom atorvastatin or simvastatin was newly initiated; and 2)~     compare cardiovascular event rates in elderly patients in whom atorvastatin or simvastatin~     was newly initiated.~   "
172699|NCT01304628|"~     The objective of this study is to evaluate if single subcutaneous (SC) doses of PL-3994,~     administered to patients with asthma can achieve a clinically meaningful increase in~     pulmonary function (Forced Expiratory Volume in one second: FEV1) while maintaining an~     acceptable safety profile. The study will characterize the bronchodilator effect, dose and~     safety of PL-3994 in a population of moderately severe, stable asthmatics following overnight~     withdrawal of beta-2 agonists.~   "
172700|NCT01304615|"~     Foundations for Health is a 12-week behavioral weight loss interventions primarily conducted~     via the internet aimed at helping overweight and obese young adults (ages 18-30) lose weight~     by increasing physical activity, decreasing the energy density of the diet, and increasing~     consumption of low energy dense self-made meals by providing culinary training skills.~   "
172701|NCT01304602|"~     This phase I trial will use the combination of irinotecan and BKM120 in patients with~     advanced colorectal cancer who have failed on or have become intolerant of at least one line~     of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy.~   "
172702|NCT01304589|"~     The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in~     women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to~     fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The~     investigators will also determine whether associated symptoms in PVD, including psychological~     distress, impairment of sexual function, physical function, and quality of life, are~     correlated with a reduction in vulvar pain.~   "
172703|NCT01304576|"~     The area of the brain responsible of visuospatial processing data and more specifically the~     orientation of an object or image is located in parietal lobe, especially on the right side.~     A dysfunction of this region would result in a disorder of recognition of the orientation of~     objects and images that the investigators call orientation agnosia. Several isolated cases~     are reported in the literature but to the investigators knowledge deficit has never been~     systematically searched, or put into perspective compared to other neuropsychological~     deficits. Moreover, the precise location of the lesion responsible for such a disorder~     remains uncertain. The objectives of this study are (1) detect the existence of orientation~     agnosia in case of right parietal lesion, and (2) to improve the understanding of such a~     deficit allowing better management of this disorder.~   "
172704|NCT01304563|"~     Intradermal influenza vaccination may result in better efficacy when compare to intramuscular~     vaccination.~   "
172706|NCT01304537|"~     Alpha-1 Antitrypsin (AAT), trade name (Glassia ®), is being explored in this phase I/II trial~     as a potential disease modifying agent in Type 1 Diabetes Mellitus (T1DM) based on its~     anti-inflammatory properties. AAT is an acute stress reactant protein that increases during~     inflammation. In T1DM inflammation serves a major role in disease progression.~   "
172707|NCT01304524|"~     This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100 DNA~     Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18~     associated Cervical intraepithelial neoplasia grade 2/3 or 3.~   "
172708|NCT01304511|"~     The purpose of this post-marketing surveillance is to identify problems and questions~     regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of~     premature luteinizing hormone (LH) surges in women undergoing controlled ovarian~     hyperstimulation (COH) for assisted reproduction techniques (ART).~   "
172709|NCT01304498|"~     Primary objective:~      • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers~     (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.~      Secondary objectives:~        -  To evaluate the tolerability of V503 in 9-15 year-old girls.~        -  To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or~          GARDASIL.~   "
172710|NCT01304485|"~     Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer~     to select patients who may benefit from directed therapy~   "
172711|NCT01304472|"~     Clopidogrel administration is considered standard of care in patients with stable coronary~     artery disease post PCI. However , a significant proportion of patients is considered~     clopidogrel resistant and this is shown to be accompanied by future adverse events. The~     hypothesis of the study is to define among consecutive outpatient clinics individuals with~     stable coronary artery disease being on chronic clopidogrel treatment, those that are~     clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel~     resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or~     clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment~     crossover will be performed without a washout period. At Day 28 platelet reactivity will be~     assessed as well.~   "
172712|NCT01304459|"~     Observational protocol to analyse routine vancomycin serum levels of patients under intensive~     care and to obtain percentage of patients that achieve therapeutic values.~   "
172713|NCT01304446|"~     CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status~     of cancer patients, leading to nutritional support. The aim was to study enteral nutrition~     indications, as well as its compliance and the impact on nutritional status.~      DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM.~      METHODS: Patients older than 1 year followed during anticancer therapy were included from~     January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0~     or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at~     these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR)~     was indicated.~   "
172714|NCT01304433|"~     The study is primarily aimed to collect further data on the safety of the investigational~     product in a large patient population when used in routine clinical practice in the~     Asian-Pacific region.~   "
172715|NCT01304420|"~     The purpose of this study is to analyse the usability of ultrasonography together with~     biomarkers in the investigation of patients diagnosed with juvenile idiopathic arthritis. The~     investigators hypothesize that serum and urine markers of cartilage and bone synthesis and~     degradation, together with ultrasound measurements of joint cartilage thickness, are useful~     tools in the early evaluation of JIA patients, - as diagnostic, prognostic and monitoring~     methods.~   "
172716|NCT01304407|"~     Osteosarcoma is the most common malignant bone tumor in children and adolescents. Because~     cure rates for osteosarcoma have remained stagnant for the past several decades despite~     numerous trials of chemotherapy agents, novel therapies based on the understanding of the~     molecular pathogenesis of osteosarcoma are needed. Rothmund-Thomson Syndrome (RTS) is a~     genetic disorder affecting many parts of the body and resulting in major skeletal~     abnormalities. This disease also has the propensity to increase the risk of developing~     cancer, particularly osteosarcoma. Two-thirds of RTS patients have a high risk of developing~     osteosarcoma. Therefore, it is important to understand the impact of RTS on the skeletal~     phenotype (as measured by calcium absorption and bone mineralization) in order to develop~     effective therapies to battle osteosarcoma.~   "
172717|NCT01304394|"~     The primary objective of this study was to provide daily information on the performance~     safety of the Ped3CB in practical therapeutic use in pediatric patients.~   "
172718|NCT01304381|"~     Patients with severe heart failure have as many symptoms as many patients with cancer but yet~     do not have equal access to supportive and palliative care. They have an unpredictable course~     of illness, which makes difficult to judge when the palliative stage has been reached. The~     Heart failure and Palliative care Programme is a three-year project in Sweden financed by the~     Swedish Association of Local Authorities and Regions (SALAR). The overall aim is to develop,~     implement and evaluate a model that integrates cardiac care and palliative advanced home care~     for patients with severe chronic heart failure. The primary aim is to study the effects on~     patients' symptom burden, quality of life and activities of daily living. A randomized~     controlled clinical study is planned.~      Patients (n=62) with a confirmed diagnosis in accordance with the criteria proposed by the~     European Society of Cardiology and with NYHA III-IV symptoms and at least one of following~     criteria will be included;~        1. At least one episode of worsening heart failure that resolved with injection / infusion~          of diuretics or the addition of other heart failure treatment in the last 6 months and~          regarded optimally treated according to the responsible physician.~        2. Need for infusions-treatment.~        3. Chronic poor quality of life (VAS < 50)~        4. Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body~          weight within the last 6-12 months)~        5. less than one year life expectancy The participants will be randomized to intervention~          or control group. The intervention consist of a multidisciplinary approach and~          collaboration between specialist palliative and heart failure (HF) caregivers, in a~          shared structured person-centred and identity-promoting care at home during six months.~          Usual care is performed for the control group.~   "
172719|NCT01304368|"~     Chronic neck pain is a common worldwide problem. In the majority of cases, patients are~     treated by medication, referral to a physiotherapist or thermotherapy. Thermotherapy - the~     therapeutic application of topical heat - provides an easy to apply self-help strategy in~     patients with chronic neck pain. However, despite the frequent use in clinical practice,~     there is no research regarding this topic yet.~      The aim of this study was to evaluate whether thermotherapy self-treatment for chronic neck~     pain induces changes in perceived pain intensity and in sensory processing.~   "
172720|NCT01304355|"~     Irritable bowel syndrome (IBS) is a common disorder affecting up to 20% of the general~     population. Despite the prevalence of the disorder, it remains poorly understood. This is~     reflected in a symptom based diagnostic scheme, the lack of a suitable biological marker and~     inadequate treatment options. Current knowledge suggests the disorder is as a result of a~     dysregulated brain-gut axis, a complex construct describing the bidirectional communication~     systems underpinning normal gastrointestinal functioning.~      The investigators hypothesize here that the disruption of this brain-gut axis is facilitated~     by an increased degradation of tryptophan along the kynurenine pathway. This metabolic~     abnormality has the potential to impact on both GI and CNS signaling through its effects on~     serotonergic signaling and the impact of metabolites like kynurenic acid and quinolinic acid~     on cognitive processes respectively.~      Previous data from our laboratory indicated increased tryptophan degradation in IBS patients~     and suggested the metabolites produced as putative biological markers of the condition. In~     this study the investigators aim to reconcile cognitive impairment in IBS with GI and CNS~     symptom severity and kynurenine pathway metabolites.~      The investigators will establish these baseline measures in IBS compared to control subjects.~     A battery of cognitive assessments will be carried out using a computerized testing system.~     Standardized rating scales will be used to assess GI and CNS symptom severity. GC-MS/MS, a~     recently acquired technology platform in our laboratory, will be used to quantify plasma~     quinolinic acid levels.~   "
172721|NCT01304342|"~     Addition of fentanyl or remifentanil to the propofol produced sedation for scheduled ERCP~     will decrease the propofol requirements for predetermined sedation levels (as shown by~     Bispectral Index Monitor (BIS) monitor), will be associated with faster recovery monitored by~     Ramsay's and Observer's Assessment of Alertness/Sedation (OAAS) scores and BIS, less~     postoperative pain (assessed by Visual Analogue Scale=VAS) and less early cognitive~     impairment after sedation (as assessed by the MiniMental test).~   "
172722|NCT01304329|"~     The objective of the study is to investigate the drug-drug interaction potential between BI~     10773 and simvastatin.~   "
172723|NCT01304316|"~     The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of~     a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline~   "
172724|NCT01304303|"~     Phase I study of SPARC1023 alone and in combination with carboplatin~   "
172725|NCT01304290|"~     Our objective in this study will be to determine if implementing the glucose/insulin clamp~     (GICT) on cadaveric organ donors can:~        -  Prevent hyperglycaemia~        -  Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours~          therapy with the GICT prior to organ procurement.~        -  Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant~        -  Assess graft function by evaluating:~             -  Liver: post-transplant liver function score (PTLF)~             -  Kidney: graft function as defined by UNOS (immediate graft function IGF, slow graft~               function SGF and delayed graft function DGF and~             -  Pancreas: 7 day post-transplant insulin requirement, C-peptide and C-RP levels at~               day one and seven post-transplantation~   "
172726|NCT01304277|"~     This study is designed to evaluate safety and PK/PD in Canadian Fabry patients.~   "
172727|NCT01304264|"~     To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is~     statistically superior to twice a day (bid) timolol with regard to increasing ocular blood~     flow~   "
172728|NCT01304251|"~     The purpose of this study is to determine the effect of short-term fasting on tolerance to~     adjuvant chemotherapy in breast cancer patients~   "
172729|NCT01304238|"~     The purpose of this retrospective registry is to collect data about patients with acute HIT~     II (Heparin-induced Thrombocytopenia type II) which were treated with Lepirudin, Danaparoid,~     Argatroban or Fondaparinux. It is a main objective of this registry to mirror the daily~     routine in this indication in Germany.~   "
172730|NCT01304225|"~     This study will investigate the clinical efficacy and safety of the PASCAL laser (PAttern~     SCAn Laser) for diabetic retinopathy. Patients with proliferative or severe nonproliferative~     retinopathy will be treated with panretinal photocoagulation utilizing different treatment~     strategies. The investigators believe that using lower laser parameters, the clinical~     response may be equivalent with less adverse effects.~   "
172731|NCT01304212|"~     The purpose of this study is to compare the analgesic effectiveness of three techniques: the~     femoral nerve block, intraarticular infiltration or a combination of both in the control of~     pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the~     performance multimodal postoperative pain KA combining two analgesic techniques to obtain~     better analgesia than when applied separately.~   "
172732|NCT01304199|"~     The purpose of this study is to assess the various aspects of life in the cancer survivors in~     India. Cancer survivor is defined as an individual diagnosed with cancer and who has~     survived the disease and treatment, and for the rest of his/her life.~      Cancer survivors are at increased risk of developing various physical and psychosocial~     conditions, which require to be identified and attended within the cancer care system.~      Survivorship research is seen as addressing the medical, functional, and health related~     issues of individuals diagnosed with cancer, as well as that of their families.~   "
172733|NCT01304186|"~     The purpose of this study is to evaluate the acceptability and efficacy of a computer-based~     tailored information application designed to promote health literacy in persons treated for~     HIV infection. The study hypothesis is that the application will be acceptable and usable for~     persons treated for HIV infection, and will improve their levels of adherence to~     antiretroviral medication treatment.~   "
172734|NCT01304173|"~     This is an observational study involving a retrospective review of medical records of adult~     patients who have been treated with intravesical valrubicin for bladder carcinoma in situ~     (CIS) since October 2009.~   "
172735|NCT01304160|"~     The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation~     therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients~     with locally advanced pancreatic cancer.~   "
172736|NCT01304147|"~     The objective of the current study is to investigate the safety and efficacy of a single dose~     of intranasal (IN) ketamine in treatment-resistant depression (TRD).~   "
172737|NCT01304134|"~     To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in~     the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v.~     PCA.~   "
172739|NCT01304108|"~     Preventing the formation of blood clots in the veins so they do not injure leg veins or~     travel to the lungs, also called venous thromboembolism prophylaxis (VTE-P) is an essential~     component of safe in-patient care, yet it is deployed sub-optimally in many hospitals,~     including The investigators own. Two prior VTE-P improvement projects were completed at Mayo~     Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of~     the Department of Surgery. Both projects resulted in marked improvement in the percentage of~     patients receiving appropriate VTE-P. This project seeks to utilize the lessons learned from~     these two pilots along with known best practices for &quot;spreading&quot; to deploy methods~     that enhance VTE-P to the entire hospitalized population. The investigators seek appropriate~     VTE-P rates exceeding 95%.~   "
172740|NCT01304095|"~     The purpose of this study is to measure the effect of ranolazine on ETT (exercise treadmill~     test) exercise duration in four ethnic subgroups with established coronary artery disease and~     risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and~     East Indian.~   "
172741|NCT01304082|"~     When one receives a local anesthetic, such as novocaine for a dental procedure, there is a~     burning painful sensation experienced upon injection of the local anesthetic. We are trying~     to understand the role of pH (how acidic a solution is) in the production of pain during~     local anesthetic administration. We hypothesize that less acidic solutions produce less~     burning. We also want to determine whether or not the pH of the solution affects the rate of~     onset of the local anesthesia. We will recruit subjects from patients who have a clinical~     indication for lumbar medial branch (LMB) nerve blocks, procedures frequently performed at~     the Massachusetts General Hospital Center for Pain Medicine. For each patient, three nerve~     blocks are administered at adjacent spinal levels, typically using either lidocaine or~     bicarbonate-buffered lidocaine as the local anesthetic. We will add a saline control as part~     of the research procedure and then provide lidocaine at the control location before~     continuing with the nerve blocks. This clinical procedure offers an ideal opportunity to~     compare the effects of the three solutions. There will be almost no deviation from the~     standard clinical procedure. After the injection of each solution, the pain score on~     administration of the medication will be recorded immediately. We will also provide a~     continuous stimulation (pin taps) after the local anesthetic injection and record when the~     patient experiences hypoesthesia (reduced sensation) and anesthesia (absent sensation).~     Finally, we will record the pain score upon reinsertion of a needle to mark the precise~     location (part of the clinical procedure) one minute after the local anesthetic injection.~     All data will be collected during the a single clinical visit.~      The study will conclude when 60 subjects have successfully been tested. Data will be reviewed~     annually.~   "
172742|NCT01304069|"~     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and~     neuropathic pain. After oral administration, tramadol is rapidly and almost completely~     absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed~     by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation~     is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral~     tramadol with selecoxib and etoricoxib. Selecoxib is known to inhibit CYP2D6. Twelve healthy~     male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of~     the ideal weight for height are taken into the study. Primary endpoints of the study are~     plasma concentrations of tramadol and its metabolites.~   "
172743|NCT01304056|"~     Respiratory muscles seem to be activating differently in critically ill patients than in~     healthy persons. Needle electrodes would provide artefact-free signal information about~     muscle activation. However, needle recordings are an invasive technique which limits its~     feasibility in clinical setting. Intention of this study is to investigate if surface~     electromyography could be used to measure recruitment patterns of ventilatory muscles.~   "
172744|NCT01304043|"~     To take charge of the treatment in rare adult ovarian tumors with an homogenous manner~     (germinal and sexual cords tumors), at different stages of the disease.~   "
172745|NCT01304030|"~     Our research hypothesis is that residents who participate in the empathy and relational~     skills training modules will significantly improve in these skills as compared to a control~     group of residents who receive residency training as usual that includes the current standard~     training in the doctor-patient relationship. To evaluate this hypothesis, we will use a~     two-pronged approach to assessment. The first prong is the residents' self assessment of~     empathy and the second is from the patients' perspective.~   "
172746|NCT01304017|"~     In Israel approximately 16,000 people have a stroke each year. Most of these people suffer~     from weakness or paralysis of half of their body which leads to difficulties performing basic~     activities of daily life (BADL) such as dressing and walking. Due to the stroke, these~     individuals need to undergo intensive rehabilitation. After rehabilitation, physical activity~     has been strongly recommended to maintain their functional level which was achieved during~     rehabilitation. In addition regular physical activity can prevent secondary condition~     However, recent findings suggest that people with stroke do not perform enough physical~     activity with their upper and lower extremities.~      The use of Virtual Reality (VR) for rehabilitation has been found to have potential for~     encouraging active purposeful movement. Many researchers have assessed the feasibility &~     usability of different VR systems and environments for individuals with stroke. Costly VR~     systems in addition to off-the-shelf video game consoles (e.g. Sony PlayStation EyeToy,~     Nintendo Wii) have been found to have great potential to encourage active purposeful~     movement. However, to date, only a limited number of studies have investigated the~     effectiveness of VR therapy post-stroke.~      Since physical activity is important after stroke and the fact that individuals with stroke~     are not participating sufficiently in physical activity, I suggest to carry out this study.~      The overall aim of this study is to assess the effectiveness of using novel technology of VR~     therapy to promote the participation in daily physical activity of individuals with stroke. A~     'Community based' VR program will be compared to a traditional therapy program in promoting~     daily physical activity of the lower and upper extremities.~      It is hypothesized that the VR intervention will be more efficient than the traditional~     therapy in promoting physical activity (walking and use of the weak upper extremity).~   "
172747|NCT01304004|"~     Worldwide, obesity rate has increased so much in the latest years, that we call it obesity~     epidemic. Overweight could result of an unbalanced energetic balance for years. The person~     who regularly consumes more calories than she expends will find herself with a positive~     energetic balance, which results in a weight gain. A daily overconsumption of only 10~     calories comes with a weight gain throughout one year. A way to avoid this overconsumption is~     to eat food that increases satiety. Satiety can be defined as the time interval after food~     ingestion, during which hunger and desire to eat are suppressed.~      The general objective of the study is to investigate in a pilot study the impact of a~     drinkable yogurt enriched in proteins and fibres on satiety.~   "
172748|NCT01303991|"~     The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate~     based photodynamic therapy in patients with intermediate or high-risk transitional cell~     carcinoma of the bladder.~   "
172749|NCT01303978|"~     Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin~   "
172778|NCT01303601|"~     Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown~     efficacy in bipolar depressive episodes in retrospective studies. However, there has been no~     prospective study about the monotherapy of olanzapine. The investigators conducted a~     randomized, placebo-controlled study to test the efficacy of olanzapine monotherapy for~     treatment of the depressed phase of bipolar disorder.~   "
172750|NCT01303965|"~     One of the complications that can occur after a stem cell transplant is called graft versus~     host disease (GVHD). Another complication is that multiple myeloma may come back (relapse).~     In this study, a drug called lenalidomide will be started 1-2 months after a transplant, or~     possibly later depending on recovery of your side effects. Lenalidomide and sirolimus have~     been shown to work together against multiple myeloma. Therefore, lenalidomide will be~     combined with sirolimus with the hope that this will help prolong the amount of time the~     disease is in remission. Researchers hope these steps will help prolong the amount of time~     the multiple myeloma is in remission and will decrease the chance of GvHD.~   "
172751|NCT01303952|"~     Evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent~     patients with untreated or refractory hemolytic cold agglutinin disease(CAD)~   "
172752|NCT01303939|"~     The purpose of the study is to determine if glaucoma is associated with neurodegenerative~     changes in areas of the brain other than the occipital lobe. This will help guide the~     direction of further research in the use of neuroprotective agents in preventing or~     controlling such changes. The final goal is to improve the quality of life for patients with~     glaucoma.~   "
172753|NCT01303926|"~     Cisplatin and pemetrexed combination or carboplatin, paclitaxel and bevacizumab are now~     considered as standard treatment in non-squamous cell lung carcinoma (NSCLC). Both main~     registrative trials are considered positive because they reached their objectives, but within~     them, the Quality of Life (QoL) of patients was not detailed neither has represented as~     primary objective of the studies. It is considered that, together with enhancements that are~     added to the knowledge of the biology of NSCLC, QoL may influence the therapeutic choice if~     one of the associations show to be better tolerated by the patient and favours an~     amelioration of his QoL.~   "
172754|NCT01303913|"~     Oxygen desaturation (SO2 < 88-90%) during walking is a common clinical feature of Chronic~     Obstructive Pulmonary Disease (COPD) patients. By a predicted analysis our study is aimed to~     evaluate anthropometric and functional characteristics of COPD patients correlated with~     oxygen desaturation during Six-minute walking test (6MWT).~   "
172755|NCT01303900|"~     Life expectancy of hemophilia patients has improved considerably during the past decades and~     is approaching that of the general population. Hemophilia patients are therefore likely to be~     confronted with age-related disorders in addition to their primary illness and related~     diseases. Little is known about the occurrence of age-related co-morbidity, especially~     cardiovascular disease (CVD), in these patients. Low clotting factor levels are hypothesized~     to protect against both atherosclerosis and thrombus formation, resulting in a reduced risk~     of ischemic CVD. CVD mortality has been reported to be lower in haemophilia patients than in~     the general population, but data on non-fatal CVD are lacking, and no adjustment for CVD risk~     factors has been made so far.~      The aim of our study is to assess the occurrence of CVD and its risk factors in a large~     cohort of haemophilia patients.~      In this prospective multicenter cohort study in a group of 700-800 male patients with~     haemophilia A or B aged 30 years or older from The Netherlands and the UK, data on CVD~     history and CVD risk factors will be collected at baseline and compared with the general~     age-matched male population. Overall QRISK2 cardiovascular risk scores will be calculated and~     also compared with the general population. During a follow-up period of 5 and 10 years the~     occurrence of CVD events will be recorded and compared with the expected occurrence based on~     the QRISK2 scores and with data from the general population.~   "
172756|NCT01303887|"~     The purpose of this study is to determine whether R-FC is more beneficial that R-CVP in the~     treatment of older patients (aged 60 or over) with Follicular Lymphoma (FL).~   "
172757|NCT01303874|"~     TRIAL DESIGN~        1. Description This is a 18-month, double-blind, randomized, multicentre, outpatient study.~          The approximate duration of subject participation will be 18 months and the approximate~          total duration of the study will be 42 months. The duration of subject enrollment will~          be approximately 24 months.~        2. Discussion of Trial Design The study is designed to directly compare the effectiveness~          of combination therapy with MTX + ETN versus~        3. Principal research question/objective To determine the number of patients in clinical~          remission at 12 months of follow−up, as defined as the absence of symptoms and signs of~          inflammatory arthritis.~   "
172758|NCT01303861|"~     This study focuses on the first step in developing an algorithm for maximizing quit-smoking~     success based on an adaptive approach, which changes treatment from the initial nicotine~     replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT~     non-responders are switched (in double-blind fashion) before the quit date to receive~     either varenicline alone or varenicline paired with bupropion. Some participants who would~     otherwise have failed at their quit smoking attempt could be rescued by switching to~     alternative pharmacotherapies. The proposed study will evaluate the combination treatment~     against varenicline alone in an adaptive trial design~   "
172759|NCT01303848|"~     To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a~     circadian rhythm~   "
172760|NCT01303835|"~     To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in high~     grade glioma patients undergoing standard chemoradiation~   "
172761|NCT01303822|"~     Emotional and mental symptoms are common consequences of cancer diagnosis and treatment.~     Coping with these symptoms seems to be influenced by interpretation of illness, locus of~     health control and spiritual attitudes in dealing with illness.~      Mindfulness-based stress reduction has been shown to reduce physical and mental symptoms in~     cancer patients.~      The aim of this study is to investigate the effect of a mindfulness-based day-care clinic~     group program on quality of life, anxiety and depression in cancer patients and to evaluate~     the association with coping styles, spiritual attitudes in dealing with illness, mindfulness~     and interpretation of illness.~   "
172762|NCT01303809|"~     The investigators wish to standardise and optimise perioperative care for consecutive~     patients undergoing laparoscopic sleeve gastrectomy for weight loss. The investigators will~     compare patients under a standardised perioperative care program to patients who undergo~     routine perioperative in our hospital and determine whether patients who had optimised~     perioperative care went home earlier and had fewer complications.~   "
172779|NCT01303588|"~     The objective of this study is to evaluate whether yoga or qigong therapy is effective in~     treating low back pain in elderly patients compared to no therapy (waiting list control). The~     secondary aim is to compare yoga and qigong.~   "
172763|NCT01303796|"~     This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at~     least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the~     doctor does not recommend the use of standard intensive treatment or the patient has decided~     not to receive standard intensive treatment after being fully informed about its benefits and~     risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating~     cycles with decitabine, or decitabine alone. The purpose of the study is to learn which drug~     regimen is more likely to keep AML in check as long as possible.~   "
172764|NCT01303783|"~     The purpose of this study is to determine the blood pressure lowering responses of various~     dose combinations of nifedipine GITS and candesartan as compared to treatment with each~     component on their own (monotherapy) and placebo (a look-alike tablet without active~     ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are~     currently approved for use in patients with essential hypertension alone or together with~     other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS~     and candesartan used together in the treatment of essential hypertension has not been~     established yet. In this study patients will be treated with various doses of nifedipine GITS~     and/or candesartan or placebo. These different regimens will be administered once a day and~     will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood~     pressure) in subjects with mild to moderate essential hypertension.~   "
172765|NCT01303770|"~     Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million~     people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive~     impairment as a result of the disease including disturbances in memory, attention,~     concentration, information processing, and executive functions such as problem solving, and~     self-monitoring. MS-related cognitive impairments negatively affect many aspects of~     functioning and independent participation in everyday life. Thus, PwMS who experience~     cognitive impairments face a wide array of recurring barriers that pose grave challenges to~     carrying out everyday activities while trying to maintain multiple life roles and as they~     age.~      Management of cognitive symptoms can be addressed through rehabilitation which has the~     potential to reduce disability, prevent complications of the disease, and enhance~     participation, independence, and quality of life. Considering the high frequency of cognitive~     impairments in MS and their significant, complex impact on functioning and independence, it~     is critical that cognitive interventions be an essential component of MS rehabilitation.~      The overarching goal of this study is to develop and test a self-management, group-based~     cognitive rehabilitation program designed specifically for PwMS.~   "
172766|NCT01303757|"~     The primary aim of the study is to examine insulin secretion as an effect modifier of the~     efficacy of a low-fat vs. low-glycemic load diet for weight loss among overweight/obese young~     adults in an 18-month, prospectively stratified, multi-center randomized controlled trial.~   "
172767|NCT01303744|"~     To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once~     per day for up to 12 weeks to patients with mild cognitive impairment.~   "
172768|NCT01303731|"~     The objectives of this study is to test a combination of low dose local anesthetic~     Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for optimal spinal~     anesthesia during Cesarean Section. The dilution of Bupivacaine with CSF in our study would~     result in effective spinal anesthesia with relatively limited motor block, quick recovery of~     motor function and relatively long lasting analgesia. We expect lower incidence of side~     effects with this combination than with convenient dose of Bupivacaine.~   "
172769|NCT01303718|"~     The purpose of the INOVATE-HF study is to demonstrate the long-term safety and efficacy of~     vagus nerve stimulation with the CardioFit® system for the treatment of subjects with Heart~     Failure.~   "
172770|NCT01303705|"~     This clinical trial will examine a novel combination of anti-OX40 to induce proliferation of~     memory and effector T cells in conjunction with cyclophosphamide (CTX) and radiation to~     induce tumor antigen release with the overall goal of promoting an immune response against~     prostate cancer.~   "
172771|NCT01303692|"~     Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and~     -plus anti-androgen agent~   "
172772|NCT01303679|"~     In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is~     currently the standard treatment. In patients expressing hormone receptors, it was shown that~     hormone therapy administered in maintenance after induction chemotherapy, could have a~     benefit regarding the progression-free survival. The investigators make the hypothesis that~     there would be interest to discontinue treatment with taxane after 4 months, and to begin~     hormone therapy while continuing maintenance bevacizumab.~      Exemestane was chosen because it has been shown potentially active in patients who progressed~     after letrozole, anastrozole or tamoxifen.~   "
172773|NCT01303666|"~     Previous studies have indicated that patient expectations, beliefs and preferences may have~     an impact on treatment outcomes. The KIVIS study was primarily designed to compare two~     effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee)~     or intra-articular corticosteroid injection). At study entry any preference expressed by the~     patient for each of the treatment interventions was recorded. This study assessed the effects~     of two treatments given at a single time-point and hence the effects of patient preference~     could be assessed independently of any compliance issues.~   "
172774|NCT01303653|"~     Gastrointestinal leaks or perforations are currently treated through either open or~     laparoscopic surgical procedures. The purpose of this research is to determine whether new~     endoscopic tools are safe and effective in the treatment of such conditions and can overcome~     the need of invasive surgical procedures.~   "
172775|NCT01303640|"~     The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is~     not inferior to the everolimus-eluting stent in terms of the rate of target-lesion~     revascularization at 1-year and death or myocardial infarction at 3-year after stent~     implantation in the real world clinical practice.~   "
172776|NCT01303627|"~     The effect of maintenance remifentanil infusion with target controlled infusion during~     laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be~     investigated.~   "
172777|NCT01303614|"~     The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain~     during hysterosalpingography diagnostic practice.~   "
172780|NCT01303575|"~     This study will evaluate the effect of an American Indian/Alaska Native (AI/AN) adaptation of~     the It's Your Game…Keep It Real (IYG) intervention, relative to a comparison condition on~     sexual behavior outcomes and psychosocial variables for middle school aged youth (12 - 14~     years old). The original IYG program was designed for students in Houston middle schools to~     help students delay sexual initiation and if sexually active, use condoms and contraception.~     The present study will adapt the existing IYG program for an AI/AN youth cohort; the original~     IYG curriculum will be transferred into a web-based format and modified to incorporate~     additional culturally-relevant components. The primary hypothesis to be tested is: (1)~     students who receive the web-based curriculum will delay sexual activity relative to those~     who receive standard care. The major dependent variable is the proportion of students~     initiating sexual activity. Secondary hypotheses will examine the effect of the web-based~     curriculum on specific types of sex and psychosocial variables related to sexual risk-taking~     behavior. This project will also examine the effect of the intervention on the proportion of~     students who are sexually active, number of times students engage in unprotected sexual~     intercourse, and students' number of sexual partners.~   "
172781|NCT01303562|"~     The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h)~     bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats,~     as well as their effects on selected measures of antioxidation, inflammation, insulin~     sensitivity/glucose regulation, and vascular remodeling following challenge by an oral~     glucose tolerance test (OGTT).~   "
172782|NCT01303549|"~     The study is a randomized, open-label safety study comparing the use of anidulafungin (200 mg~     i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin B (3~     mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.~   "
172783|NCT01303536|"~     The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve~     and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms~     among obsessive compulsive disorder resistant patients.~   "
172784|NCT01303523|"~     The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin~     complications in patients with a lower limb trauma supported by physicians of mountain.~   "
172785|NCT01303510|"~     A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal~     V fulfills the EMEA requirements for re-registration of influenza vaccines~   "
172786|NCT01303497|"~     Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma~   "
172787|NCT01303484|"~     The purpose of this study is to determine the effects of prebiotic B-GOS on the immune~     function, metabolism and gut microbiota of elderly people~   "
172788|NCT01303471|"~     During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid~     treatment is used for pain assessment.~      The change in haemodynamic variables and clinical sign are evaluated during anesthesia for~     pain assessment but these changes are not specific every time.~      The main of this study is to investigate the relationship between calculated compartment~     concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability)~     and APV (Arterial Pressure Variability) before a standard noxious stimulation during general~     anesthesia at calibrated hypnosis level.~      Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and~     that these effects would be blunted or abolished by by adequate analgesia. The current study~     is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during~     nociceptive surgical stimulation, at different levels of analgesia.~   "
172789|NCT01303458|"~     This research project is aimed to address low-income families' basic social needs (housing,~     food, employment, education, childcare, utilities) within the context of pediatric primary~     care. This project builds upon the PI's prior study at Hopkins which demonstrated a positive~     impact of a similar intervention on pediatric residents' screening and referral to community~     agencies. This study will specifically test whether a further strengthened~     intervention--Basic Needs Surveillance (BNS) protocol-- can lead to greater maternal~     enrollment in community resources and receipt of eligible benefits. In addition, we will~     measure the intervention's impact on maternal well-being, and compliance with well-child care~     (WCC) visits.~      The project will take place at eight community health centers in the Greater Boston Area. The~     centers will be randomized to either an intervention or control site. Mothers who bring their~     infant in for a WCC visit from birth to 6 months will be eligible. They will be followed~     until their child is one year of age. Study subjects will complete two self-administered~     surveys (baseline, follow-up), and one brief telephone interview (when their infant is 9~     months old). Pediatric providers will also be subjects; and will fill out a demographic~     questionnaire at the time of enrollment.~      The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill~     out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing~     1-page information sheets on resources, that providers will have access to in exam rooms; 3)~     a Community Resource Coordinator who will assist families link to available resources, and~     update providers; 4) Training Session which will provide a 1 hr overview of the intervention~     to providers.~      Families attending the control health centers will receive standard of care. Enrolled mothers~     will be offered the intervention at the end of the 12-month follow-up interview. When~     follow-up data collection is complete, the PI will offer the control sites the opportunity to~     implement the BNS protocol.~   "
172790|NCT01303445|"~     The objective of the current study is to investigate if a drug-drug interaction occurs with~     the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of~     dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition~     (components of Aggrenox®) when administered every 12 hours at steady state.~   "
172791|NCT01303432|"~     The purpose of this study is to determine whether the daily eating of a yogurt supplemented~     with Mobile is effective in improving joint function and quality of life of individuals with~     low intensity gonalgia.~   "
172792|NCT01303419|"~     Enrolled women will undergo a bilateral 2-view DE-CEDM examination after administration of an~     iodinated contrast agent. Separate readers on-site will evaluate DE-CEDM+MX (standard~     mammography) and CE-BMRI+MX to determine the extent of disease. An integrated reading of both~     sets of images will be performed either by one or the two readers. DE-CEDM will not be used~     to change the diagnosis. Lesions that are confirmed as suspicious by MX, CE-BMRI, or~     follow-up breast ultrasound (US) will undergo biopsy. Truth about extent of disease will be~     based on histologic analysis of surgical specimens along with follow-up MX 10-15 months after~     the study exam. A randomized, blinded image evaluation will be done with 11 to 15 radiologist~     readers to compare DE-CEDM+MX and CE-BMRI+MX for assessment of disease extent.~   "
172825|NCT01302990|"~     This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter,~     dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single~     non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.~   "
172793|NCT01303406|"~     This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to~     further investigate the effects of idebenone in patients with Friedreich's ataxia.~      The objective of the PROTI study is to establish whether patients can correctly determine~     which treatment assignment (placebo or idebenone) they received during the randomised phase~     of the trial, and identify any potential changes on symptoms or activities.~   "
172794|NCT01303393|"~     Aim The overall aim was to investigate information needs after surgery for colorectal cancer~     and factors explaining information needs, both from the patients' perspective and the next of~     kin's.~   "
172795|NCT01303380|"~     This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics~     (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.~   "
172796|NCT01303367|"~     U.S. Food and Drug Administration (FDA) and other countries issue warnings on the off-label~     use of antipsychotics in demented patients with behavioral and psychological symptoms of~     dementia (BPSD) (FDA warning, 2003; 2005; 2008). There is a significant increase in mortality~     rate by 1.6 fold due to cardiovascular events and aspiration pneumonia in the demented~     patients received antipsychotics comparing to placebo group. However, the prescription rates~     of antipsychotics in demented patients are still increased by 20% after several alerts in~     Canada (Valiyeva et al., 2008).~   "
172797|NCT01303354|"~     The aim of this study is to assess the effectiveness and safety of dexamethasone for~     transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on~     the lowest most effective dose of dexamethasone for this treatment and the effective duration~     of effect.~   "
172798|NCT01303341|"~     This phase I trial studies the side effects and best dose of sorafenib tosylate when given~     together with riluzole in treating patients with solid tumors or melanoma that has spread to~     other places in the body and usually cannot be cured or controlled with treatment. Riluzole~     may stop or slow the growth of tumor cells. Sorafenib tosylate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving riluzole together with~     sorafenib tosylate may kill more tumor cells.~   "
172799|NCT01303328|"~     The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel~     containing an antiviral, administered directly on cervix exhibiting high grade squamous or~     glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.~   "
172800|NCT01303315|"~     To assess the TANTALUS therapy in type 2 diabetic patients who can not tolerate GLP-1 agonist~     due to unacceptable side effects; and to assess the TANTALUS therapy in type 2 diabetic~     patients who do not sufficiently benefit from GLP-1 receptor agonist therapy~   "
172801|NCT01303302|"~     Evaluation of the safety and efficacy of gastric contractility modulation (GCM) stimulation~     using the TANTALUS System in the improvement of glycemic control measured by changes in~     HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be~     evaluated~   "
172802|NCT01303289|"~     The main objective of this trial is the clinical evaluation of a normoproteic diet, when this~     diet is used for total enteral nutrition in geriatric people.~      For 3 months,all the participants in the study will receive only tube feeding: The~     experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®,~     Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott~     Laboratories).~   "
172803|NCT01303276|"~     Ranibizumab (Lucentis, Genentech) is an off-label drug used for the clinical treatment of~     central retinal vein occlusion, which is one of the most common retinal vascular disorders.~     Despite its clinical effectiveness, concerns remain regarding the systemic effects of the~     drug and previous studies have noted retinal arteriolar vasoconstriction following a~     ranibizumab injection. We aim to provide a physiological basis to these observations by~     assessing retinal blood flow before and after the ranibizumab injections. Specifically, we~     will assess the blood flow parameters (i.e. retinal vessel diameter, velocity & flow)~     immediately before the first injection and post-injection over a follow-up continued~     treatment period.~   "
172804|NCT01303263|"~     OBJECTIVE: To test a brief intervention designed to improve the cost-effectiveness of care~     provided by medicine housestaff for hospitalized patients.~      HYPOTHESIS: A brief intervention in which medicine residents receive itemized bills for~     recent patients cared for by them, followed by a discussion on approaches to reducing~     unnecessary inpatient costs, can result in significant cost reductions without adversely~     affecting patient outcomes.~   "
172805|NCT01303250|"~     The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl~     starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid~     management will be given to optimize the stroke volume variation <= 12%.~      The investigators hypothesize that patients in the intervention group will need less fluid~     administration be optimal hemodynamic stabilized.~   "
172806|NCT01303237|"~     This prospective, observational, multicentre, post marketing surveillance study will collect~     safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of~     the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the~     locally approved label.~   "
172807|NCT01303224|"~     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder~     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial~     aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor~     antagonist Ibodutant in improving IBS-D symptoms.~   "
172808|NCT01303211|"~     Major epidemics of meningococcal meningitis occur in countries of the African Sahel and~     sub-Sahel every few years. Most of these epidemics are caused by meningococci belonging to~     serogroup A. Until recently there has been no serogroup A conjugate vaccine available to~     prevent epidemics in Africa because none of the major pharmaceutical companies wanted to~     develop such a vaccine for commercial reasons. For this reason a public private partnership~     was established in 2001, the Meningitis Vaccine Project (MVP), with support from the Bill and~     Melinda Gates Foundation, to develop an affordable new serogroup A meningococcal conjugate~     vaccine for Africa. The new vaccine, MenAfriVac™, received WHO pre-qualification in 2010 and~     mass campaigns started in Burkina Faso, Mali and Niger in 2010. It is expected that full~     coverage through mass vaccination campaigns will be achieved by the end of 2011 in these~     three countries. A case-control study will be conducted in Mali and Niger during the epidemic~     seasons of 2012 and 2013 to assess the efficacy of MenAfriVac™.~   "
172809|NCT01303198|"~     Part 1.Comparison of manual pressure titration in laboratory of sleep disorders with Autoset~     T APAP device from Resmed. Hypothesis: There is no difference in efficiency between manual~     and automatical titration.~      Part 2. Comparison of CPAP and APAP therapy in the home while 3 month by Questionaire and~     device data.~      Hypothesis: There is a difference in compliance and efficiency between CPAP and APAP mode.~   "
172810|NCT01303185|"~     The treatment options for nail psoriasis have been limited, and the management of nail~     psoriasis has been challenging for physicians.To evaluate the effect of pulsed dye laser~     (PDL) in the treatment of nail psoriasis.~   "
172811|NCT01303172|"~     To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in~     combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL),~     clinical signs and symptoms of disease, selected markers of tumour burden and immunological~     status, and disease outcome.~   "
172812|NCT01303159|"~     The purpose of this study is to assess safety and ability of the endoscopic bipolar~     radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of~     cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat~     the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes~     coagulated and this may delay tumour growth and the time before the stent lumen becomes~     blocked. Thereby, allowing increased periods between the need for intervention and further~     stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open~     longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.~   "
172813|NCT01303146|"~     There is currently no effective treatment for late infantile MLD once clinical symptoms are~     evident. METAZYM is a recombinant human arylsulfatase A developed for an intravenous ERT for~     the treatment of late infantile MLD. The overall objective of this study is to evaluate the~     efficacy and safety of intravenous rhASA treatment in a patient with late infantile MLD who~     had previously received hematopoietic stem cell transplantation (HCT).~   "
172814|NCT01303133|"~     The primary objective of this study is to assess the presence of amyloid in~     non-demented/functionally stable adults with DS as a function of age, dividing the sample~     into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive~     measures across a range of areas that are often affected by AD.~   "
172815|NCT01303120|"~     The aim of this study is to compare the efficacy of the analgesic effect of the preoperative~     femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral~     cutaneous nerve blocks in patients after TKA in the immediate postoperative period.~   "
172816|NCT01303107|"~     The purpose of this study is to determine if the mixture of enantiomers of bupivacaine~     (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the~     racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).~   "
172817|NCT01303094|"~     This randomization discontinuation trial will allow for concomitant evaluation of the~     following:~        -  Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle~        -  Side effects and benefits of a drug holiday~   "
172818|NCT01303081|"~     Financial incentives may be more effective than other approaches to smoking cessation, but~     research is needed to identify the optimal structures of incentives. The investigators will~     conduct a pilot randomized trial comparing different incentive structures for smoking~     cessation. Collaborating with Walgreens leadership, the investigators will enroll their~     employees in this RCT using the investigators new web-based research infrastructure (called~     the Way to Health platform, and approved as a Prime protocol by the IRB as reference #~     811860).~      Hypothesis: providing patients with financial incentives can promote healthier behaviors~     (e.g.: quit smoking).~   "
172819|NCT01303068|"~     The purpose of this study is to determine if inhaled urea can be used to detect the presence~     of Pseudomonas Aeruginosa in the lungs~   "
172820|NCT01303055|"~     It is reported that pancreatic beta cell function is already declined at pre-diabetic stage,~     impaired glucose tolerance (IGT). It has not been clarified whether inhibitors of the~     dipeptidyl peptidase IV enzyme (DPP-IV inhibitors) improve beta cell function on human~     pancreas, however, if efficacy is ensured, they may become the first medicine to be chosen~     for treatments of type 2 diabetes and IGT.~      In this trial, a DPP-IV inhibitor, Alogliptin, or Metformin are given to diabetic patients~     whose HbA1c level is below 7.9%. Oral glucose tolerance test (OGTT) will be conducted before,~     a year after, and two years after the beginning of the trial and beta cell function will be~     evaluated.~   "
172821|NCT01303042|"~     Insulin therapy with lispro mix 50/50 t.i.d. is a treatment with a single insulin device. The~     management is comparatively simple and easy, but the curative effect is promising. It is also~     reported that noninferiority has been observed between basal/bolus therapy (BBT) and prandial~     premixed therapy (PPT, lispro mix 50/50 t.i.d.).~      The purpose of this study is to evaluate whether change of insulin therapy from BBT~     (long-acting insulin at bedtime plus mealtime rapid-acting insulin) or analog insulin therapy~     t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) to lispro mix 50/50~     t.i.d. improves glycemic control of patients with type 2 diabetes mellitus.~   "
172822|NCT01303029|"~     The purpose of the study is to evaluate the efficacy of the combination of~     gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic~     pancreatic cancer.~   "
172823|NCT01303016|"~     The purpose of this research study is to better understand how to prevent malnutrition in~     children under age 5 years in Intibuca, Honduras. A randomized community trial design was~     used to implement a nutrition program, including a complementary nutrition supplement,~     educational sessions, and growth and health monitoring integrated into the basic primary care~     package, to participants living in communities in the intervention group. Participants living~     in the control group communities will receive the nutrition supplement for one year following~     the study.~   "
172824|NCT01303003|"~     Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal~     surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to~     prolong the effective duration of analgesia in several different peripheral nerve blocks. The~     study will examine, in a blinded, prospective and randomized fashion, whether the addition of~     dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The study will~     compare local anesthetic with and without the addition of dexamethasone in the TAP block.~   "
172826|NCT01302977|"~     The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is~     higher than 90% due to severe pulmonary hypoplasia. Many studies have suggested that fetal~     tracheal occlusion may increase lung volumes and therefore reducing the risk for severe~     pulmonary hypoplasia and by consequence the risk for neonatal death.~      The main objective of the present study is to evaluate if fetal tracheal occlusion improves~     survival rate in those cases that are followed in our hospital, by conducing a randomized~     trial.~   "
172827|NCT01302964|"~     This study will determine the effectiveness of mirtazapine in reducing anxiety in children~     with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.~   "
172828|NCT01302951|"~     The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in~     serum and liver tissue of patients undergoing liver resection due to primary or secondary~     tumor of the liver.~   "
172829|NCT01302938|"~     To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in~     subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative~     web-based trial design~   "
172830|NCT01302925|"~     The purpose of this phase 1 trial is to investigate the local tolerability on the finger~     following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3~     consecutive days.~   "
172831|NCT01302912|"~     Imaging techniques have considerably improved over the last decades and ocular adnexal~     lymphomas (OALs) nowadays can be detected. As major advances in immunophenotyping and~     molecular diagnostics in histology have been achieved offering an accurate diagnosis, the~     investigators would like to introduce that surgical biopsy of an orbital lymphoma becomes~     crucial for the possibility of a correct diagnosis and proper treatment. As radiotherapy~     accomplished great preciseness as well and OALs respond excellently to radiation, this~     therapy should be the treatment of choice in local defined lymphomas instead of blind~     treatment with steroids. Radiation results in great local control rates of 85% to 100%~        -  Trial with surgical intervention~   "
172832|NCT01302899|"~     The study is designed to primarily assess the effect of aliskiren on albuminuria in patients~     with non-diabetic nephropathy when treated with ramipril and volume intervention.~   "
172833|NCT01302886|"~     This study will assess the antimyeloma effects of BHQ880A in patients with smoldering~     multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be~     administered every 28 days in previously untreated patients. Disease assessments will be~     performed monthly and effects on bone metabolism will be assessed by measurement of serum and~     urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of~     BHQ880 as a single agent and following multiple doses will be obtained.~   "
172834|NCT01302873|"~     This study will assess the efficacy of a two week treatment with BGG492 in patients with~     chronic subjective Tinnitus.~   "
172835|NCT01302860|"~     This trial will assess the safety, efficacy and tolerability of ACZ885 in patients aged 4~     years and younger with cryopyrin associated periodic syndromes (CAPS)~   "
172836|NCT01302847|"~     Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study will test~     the safety of and immune response to DTG in HIV-1 infected infants, children, and~     adolescents.~   "
172837|NCT01302834|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.~     Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. It is not yet known whether radiation therapy is more~     effective with cisplatin or cetuximab in treating oropharyngeal cancer.~      PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to~     see how well it works in treating patients with oropharyngeal cancer.~   "
172838|NCT01302821|"~     The purpose of this research project is to create images of where and how the amino acid (the~     building blocks of proteins)Tryptophan is processed in normal and abnormal tissue in the~     patient's body. Tryptophan is a normal building block of proteins in the body. Sometimes in~     the case of cancer and other diseases, Tryptophan is processed abnormally, and possible~     treatments for this abnormality are of great interest because of the potential to improve~     cancer care.~   "
172839|NCT01302808|"~     RATIONALE: Romidepsin and erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of romidepsin when~     given together with erlotinib hydrochloride and to see how well they work in treating~     patients with stage III or stage IV non-small cell lung cancer.~   "
172840|NCT01302795|"~     This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of~     subjects with pyoderma gangrenosum.~   "
172841|NCT01302782|"~     The purpose of this research study is to observe whether there is a change in blood glucose~     levels in response to a 2 hour oral glucose tolerance tests (OGTT) during acute normobaric~     hypoxia (short term low oxygen levels at normal ambient air pressure).~   "
172842|NCT01302769|"~     The purpose of this study is to compare ear acupuncture plus standard of care versus standard~     therapy (anti-inflammatory medications) in the reduction of pain, reduction in oral anti~     inflammatory medication use, hours lost from work in acute sore throat.~   "
172843|NCT01302756|"~     The purpose of this study is to determine if higher-than usual doses of daily folic acid has~     an effect on the rate of gestational diabetes mellitus (GDM) or gestational hypertension in~     pregnant women while determining status of folic acid, vitamin B12, homocysteine and vitamin~     D in pregnancy.~   "
172844|NCT01302743|"~     The purpose of this study is to assess whether Cinnamon bark or water-soluble cinnamon is an~     effective nutraceutical for the initial treatment of diabetes when compared to standard~     therapy of Metformin.~   "
172845|NCT01302730|"~     This study aims to test whether a new instrument (questionnaire) is useful for identifying~     patients with ankylosing spondylitis.~   "
172846|NCT01302717|"~     In this study, the investigators will examine whether left ventricular pacing is superior to~     right ventricular apical pacing in preventing deterioration of left ventricular systolic~     function and cardiac remodeling in patients with bradycardia with high risk for development~     of pacing-induced heart failure.~   "
172848|NCT01302691|"~     This study is being done to evaluate the efficacy, safety, and tolerability of losartan~     potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5)~     (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean~     trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5~     in Japanese participants with essential hypertension who are not adequately controlled~     following an 8-week treatment with filter period study drug (L50+A5).~   "
172849|NCT01302652|"~     The purpose of this research study is to study the effects of growth hormone (GH) replacement~     on the heart. The investigators will study these effects in people who have been cured of~     acromegaly and then have developed growth hormone deficiency (GHD, not enough growth~     hormone).~   "
172850|NCT01302639|"~     There are strong indications that (combinations of) polyphenols may be attractive candidates~     in the prevention of the metabolic syndrome and diabetes through modulation of pathways of~     fatty acid metabolism and mitochondrial function. We hypothesize that the combination of~     specific polyphenols, with partly distinct mechanisms of action, may have physiologically~     significant effects on fat oxidation through additive or synergistic effects, thereby~     improving body composition, insulin sensitivity and preventing type 2 diabetes. The following~     objective will be addressed in the current study:~      (1) to test short term (3 day) effects of combinations of polyphenols (supplements of EGCG~     either in combination with resveratrol or with resveratrol and genistein) to affect systemic~     lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high~     fat meal in overweight subjects~   "
172851|NCT01302626|"~     Aim of the study: The main aim is to collect data of patients with lung cancer, and to~     perform different analyses on this data. The data contains information on patient and tumor~     characteristics, imaging, and treatment characteristics. With this data it is possible to~     improve and validate the predictive model for survival and long term toxicity in lung cancer~     by multicentric prospective data collection. The long term aim, beyond this specific study,~     is to build a Decision Support System based on the predictive models validated in this study.~      Hypothesis: The general hypothesis is that we get a better prediction in terms of AUC (area~     under the curve) of survival and long term toxicity when we combine multifactorial variables.~     These variables consist of information from clinical data, imaging data, data related to~     treatment type and treatment quality.~   "
172852|NCT01302613|"~     The primary objective of the pilot portion of this study is to establish the safety and~     tolerability of an extended treatment break period in patients who have undergone neoadjuvant~     chemoradiotherapy as well as use of systemic therapy during this break.~   "
172853|NCT01302600|"~     Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients~     aged 3-25 years~   "
172854|NCT01302587|"~     This study is evaluating the effectiveness of a dose counter for an inhaler device used to~     deliver medication to people diagnosed with asthma or COPD.~   "
172855|NCT01302574|"~     The purpose of this study is to determine the functional significance of sweet taste~     receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific~     sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal~     tract.~   "
172856|NCT01302561|"~     The purpose of this research study is to determine whether a functional fiber,~     galactooligosaccharide, can help maintain immune strength and digestive health in free-living~     older adults. It is hypothesized that older adults consuming the fiber daily for 24 weeks~     over cold and flu season will have more healthy days due to a proliferation of beneficial~     bacteria within the colon which alters cytokine production and enhances natural killer cell~     function. Immune and gastrointestinal health will be evaluated via daily questionnaires~     obtained from 80 participants and from the collection of blood and fecal samples.~   "
172857|NCT01302548|"~     The purpose of this study is to determine if wound cleansing and irrigation using the~     IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized~     stream, will improve the outcome for infected abscesses in patients that present in the~     emergency department.~   "
172858|NCT01302535|"~     The purpose of this study is to determine the effects of yoga on blood pressure and quality~     of life in patients in primary health care diagnosed with hypertension within the last year.~     Another purpose is to examine whether the possible effect on blood pressure differs if~     patients practice yoga in a group lead by a yoga-trainer or receive a few yoga-exercises from~     their doctor to be practiced individually at home.~   "
172859|NCT01302522|"~     Spinal cord injury (SCI) is a disabling condition that impairs fundamental abilities, such as~     ambulation, respiration, and toileting. Compromised ambulation is a common, devastating~     impairment following SCI. Yet, despite the fundamental desire to walk, no conventional~     rehabilitation regimen reliably improves ambulation after SCI, and many SCI patients do not~     have reliable transportation access, decreasing community integration and access to needed~     services, including rehabilitation. Little is also known about the subtle neural events that~     may predict motor recovery in incomplete SCI patients. This study will test a novel, safe,~     easy to implement technique that has shown promise in improving gait in incomplete SCI~     patients. The investigators expect that this study will confirm the efficacy of this~     technique, by showing that it increases the speed and efficiency of walking. This outcome is~     expected to produce a therapy that improves outcomes and health, and reduces care costs, for~     community dwelling patients with incomplete SCI.~   "
172860|NCT01302509|"~     CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status~     of cancer patients, leading to nutritional support. The aim was to study enteral nutrition~     indications, as well as its compliance and the impact on nutritional status.~      DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year~     followed during anticancer therapy were included from January 2002 to January 2004. They~     received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a~     weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was~     observed, tube feeding with the same supplement (TFR) was indicated.~   "
172883|NCT01302210|"~     Our hypothesis for the DERAIL MRSA program is that one can safely remove the colonization~     risk from nearly all residents (patients) in a way that does not interfere with the desired~     life-style for persons in these facilities and thereby reduce the risk of infection and lower~     the cost of care by avoiding preventable disease.~   "
172861|NCT01302496|"~     The CTLA-4 blocking monoclonal antibody ipilimumab (MDX-010, BMS-734016), has demonstrated~     anti-tumor activity in a subgroup of patients with Stage III (unresectable) or Stage IV~     melanoma (measurable per modified WHO criteria), who have received prior treatment with any~     regimen (non-experimental or experimental), except a CD-137 agonist or a CTLA4 inhibitor or~     agonist and relapsed, failed to respond (CR or PR) or did not tolerate that regimen (Wolchok,~     Neyns et al. 2009; O'Day, Maio et al. 2010). Ipilimumab exerts its therapeutic effect~     presumably by activating T-lymphocytes that infiltrate the tumor mass to destroy the~     malignant cells by mechanisms of cytotoxic cellular interaction. Autologous TriMix-DC vaccine~     can induce a T-cell repertoire that recognizes in a HLA-restricted way the melanoma~     associated antigens MAGE-A3, MAGE-C2, tyrosinase and gp100. Administration of ipilimumab~     together with TriMix-DC vaccine therapy may be a more effective treatment for patients with~     advanced melanoma as compared to either modality alone.~   "
172862|NCT01302483|"~     The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3%~     tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental~     procedures.~   "
172863|NCT01302470|"~     The primary goal of this study is to evaluate the use of robotically -assisted device leads~     as a primary strategy for heart resynchronization.This trials aims to compare transvenous~     lead placement with robotic lead placement for cardiac resynchronization therapy.~   "
172864|NCT01302457|"~     There have been multiple articles done regarding oral hygiene on patients in burn and~     intensive care patients. All articles agree the need for good oral hygiene in these special~     needs patients. They also note that more research needs to be done on this subject, yet have~     no direction of how to proceed in this research. Currently, no research has been done on the~     burn/intensive care patient to see if there is a difference form the non-hospitalized patient~     which oral hygiene protocol is based on.~   "
172865|NCT01302444|"~     Objectives: To test whether the combined administration of the medications treprostinil(a~     prostacycline therapy), and tadalafil(a PDE-5 [ phosphodiesterase type 5]Inhibitor therapy)~     is better than the administration of treprostinil alone. This treatment would be offered to~     newly diagnosed patients with pulmonary arterial hypertension who are on no treatment for~     this disease and are deemed candidates for the medication treprostinil by their physician.~     The combination therapy will be compared to single therapy with only treprostinil in a~     double-blind manner.~      Current therapy is to begin one treatment, either a PDE5 inhibitor or a prostacycline,~     depending on the severity of the patient's PAH (pulmonary arterial hypertension) disease and~     add additional therapies as deterioration occurs. This treatment could add two agents~     initially.~      Secondary objectives are: To improve pulmonary arterial pressures as measured through a~     cardiac echocardiogram, improve the subject's 6minute walk distance, delaying the time to~     clinical worsening, and lowering plasma BNP levels.~      Research Procedures: To begin the administration of both treatments at the same time.~      Time period is 16 weeks with a one- year follow-up. Cardiac Echocardiograms, clinic physician~     exams, and lab work will be followed. Subjects will be between the ages of 18 - 75.~   "
172866|NCT01302431|"~     The primary aim of this study is to determine if a manual based telephone intervention~     support service for people who support people with Multiple Sclerosis (PwMS), initiated by~     nurse specialists who provide care to PwMS, has a positive impact on the lives of PwMS and~     their support persons. For support persons this impact is determined by measurable support~     person/carer self-efficacy and preparedness to care, burden, quality of life, service~     utilization and satisfaction with the support service. For PwMS this is determined by their~     qualitative experience of the type of care they receive from their carer. A secondary aim is~     to determine the possible economic benefits of the introduction of such an intervention~     nationally. A support person is the person nominated by the PwMS as the person who provides~     the most support or physical assistance to a person with MS who is not a paid service~     provider.~   "
172867|NCT01302418|"~     The study will be conducted using nasopharyngeal swab specimens collected prospectively from~     individuals suspected of having the signs and symptoms of an acute respiratory tract~     infection caused by a respiratory virus. A series of standard viral culture tests validated~     for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed~     Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the~     performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II~     Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot~     will be tested in real-time using the assigned viral culture reference methods; (b) one~     aliquot will be used to extract nucleic acid in real-time for investigational testing; (c)~     one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference~     laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent~     follow-up by the reference laboratory (e.g., bi-directional sequencing of positive~     specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The~     extracted nucleic acid generated from the second aliquot (i.e., b above) will be split and~     subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced~     Panel test.~   "
172868|NCT01302405|"~     PRI-724 is a new investigational drug being studied to treat subjects with cancer who have~     advanced solid tumors. PRI-724 is thought to work by blocking the Wnt signaling pathway that~     cancer cells need to grow and spread(metastasize).~      Phase Ia: Patient cohorts with solid tumor malignancies will be treated with escalating doses~     (per cohort) of PRI-724 in order to identify the MTD of this single-agent regimen. PRI-724~     dosing is to start at 40 mg/m2/day, CIV infusion over 24 hours × 7 days.~      Phase Ib: This phase is to begin upon identification of the MTD in Phase 1a. Patient cohorts~     with CRC will be treated with escalating doses (per cohort) of PRI-724 administered in~     combination with a modified regimen of FOLFOX6 (mFOLFOX 6, standardized doses and schedule)~     in order to identify the MTD of this combined regimen. Up to 2 dose levels of PRI-724 are to~     be examined (640 and 905 mg/m2/day, CIV infusion over 24 hours × 7 days), with potential to~     evaluate a previously unexamined intermediate dose, if indicated, to more fully characterize~     tolerability. The MTD cohort (or maximum dose to be studied) will be expanded up to 12~     patients.~   "
172869|NCT01302392|"~     This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens~     for subjects with multiple myeloma who have received all available approved treatment options~     and may therefore be considered candidates for palliative care.~   "
172870|NCT01302379|"~     This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle~     intervention and metformin (a drug used to treat diabetes) to investigate how these~     treatments, alone or in combination, affect biomarkers associated with breast cancer~     survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast~     cancer survivors. After completing the screening process and baseline measures, participants~     will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle~     intervention and placebo, or (4) lifestyle intervention and metformin. The interventions will~     last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and~     6 months.~   "
172871|NCT01302366|"~     This study proposes to determine the clinical activity of this agent in patients with~     asymptomatic multiple myeloma. It is believed that TBL12 will help delay the onset of active~     multiple myeloma, with very few-if any- side effects.~   "
172872|NCT01302353|"~     In this trial, our primary goal is to investigate the safety of intravenous infusion of~     emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified~     Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of~     acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop~     severe adverse event in any dose group or any volunteer develop fatal adverse event in any~     group.~   "
172873|NCT01302340|"~     Dementia is a common chronic condition, with predicted increasing prevalence. Nearly all~     patients with dementia will experience neuropsychiatric symptoms (NPS). This causes~     significant burden for the individual patients and their caregivers. Current treatment has~     only modest efficacy and important side-effects. Formulations with Δ9-tetrahydrocannabinol~     (THC), the psycho-active compound of cannabis, are currently being registered for spasms in~     multiple sclerosis and other diseases, and may have beneficial effects on NPS.~   "
172874|NCT01302327|"~     Wolfram syndrome, also referred to as DIDMOAD (diabetes insipidus, diabetes mellitus, optic~     atrophy and deafness) is a genetic syndrome characterized by beta-cell dysfunction and~     apoptosis leading to diabetes, neurodegeneration and psychiatric illness. Accumulating~     evidence indicates that beta-cell failure and neuronal cell dysfunction in Wolfram's syndrome~     results from a high level of ER stress in affected cells. The current treatment of Wolfram~     syndrome is insulin, which fails to prevent the progression of beta-cell failure.~      Several studies showed that GLP-1 analogs are very effective in protecting beta-cells from ER~     stress. Herein, the investigators suggest studying the impact of GLP-1 analogs in the~     treatment of patients with Wolfram syndrome.~      The investigators will Study the effects of GLP-1 analog (Exanatide) on beta-cell function~     and glycemic control of patients with Wolfram syndrome. Evaluation of beta cell function will~     be done by performing meal test and IVGTT test before starting GLP-1 therapy, and after 3~     month of treatment.~   "
172875|NCT01302314|"~     This study will examine the effects of a theoretically grounded and manualized cognitive~     rehabilitation program on patients with Spina Bifida (SB). SB is often associated with~     deficit in higher order control over cognition, emotion and behaviour; which is typically~     referred to as executive functions. The present study will examine the efficacy of Goal~     Management Training (GMT) in patients with SB that experience executive difficulties. It is~     expected that GMT will have a favourable effect on cognitive executive functioning,~     psychological and health related factors.~   "
172876|NCT01302301|"~     Achalasia and esophageal spasm are primary esophageal motility disorders where the lower~     esophageal sphincter fails to relax in response to swallowing with no well understood~     underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose~     of this study is to evaluate flexible endoscopic myotomy a novel therapeutic approach to~     overcome the need for invasive surgery.~   "
172877|NCT01302288|"~     Achalasia is a primary esophageal motility disorder where the lower esophageal sphincter~     fails to relax in response to swallowing with no well understood underlying cause. Surgical~     myotomy represents an appropriate therapeutic option. The purpose of this study is to~     evaluate flexible endoscopic myotomy, a novel therapeutic approach to overcome the need for~     invasive surgery.~   "
172878|NCT01302275|"~     The purpose of this trial is to determine if the effect of oxcarbazepine on chronic~     peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine~     mainly relieve pain in patients with irritable nerves.~   "
172879|NCT01302262|"~     This study will evaluate effects of smoking on the dopaminergic system by using PET~     tomography with new radioligand, [11C]-(+)-PHNO. Our primary hypothesis is that smoking a~     cigarette will produce dopamine release and this release can be measured using PET imaging~     and the [11C]-(+)-PHNO radiotracer. The secondary hypothesis is that this smoking induced~     dopamine release will be correlated with subjective craving and anxiety ratings.~   "
172880|NCT01302249|"~     This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of~     the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular~     pressure (IOP).~   "
172881|NCT01302236|"~     The purpose of this study is to determine whether eplerenone is effective in the treatment of~     blood pressure, heart function, renal function in elderly hypertensive stage1~     (eGFR>=90ml/min/1.73m2) and stage2 (eGFR 60-89ml/min/1.73m2) chronic kidney disease (CKD)~     patients.~   "
172882|NCT01302223|"~     KERATINOCYTE GROWTH FACTOR AND CYTOKINES IN SKIN BURNS.~      INTRODUCTION: Intense inflammatory responses are activated by burns that affect a large total~     body surface area. Changes in plasma levels of cytokines after burns occur before metabolic~     abnormalities unsettle the patient. So it may be possible to develop therapeutic~     interventions that may attenuate the acute inflammatory response by decreasing the expression~     of these cytokines. The importance of growth factors in the healing process was demonstrated~     in cultured keratinocytes and fibroblasts. The keratinocyte growth factor (KGF) is a growth~     factor active in the repair of wounds, being the most potent stimulator of mitotic cells.~      PURPOSE: To assess the level of keratinocyte growth factor (KGF) and IL-1ß, IL-6, IL-8,~     IL-10, IL-12 and TNF-alfa of patients with burns produced by cultured primary dermal~     fibroblasts and the gene expression.~      METHODS: 10 patients will be include (05 patients in the study group and 05 patients in the~     control group) admitted to the Burns Care Unit of the Discipline of Plastic Surgery, Federal~     University of São Paulo (UNIFESP) between 25% and 50% of total body surface area (TBSA), deep~     second-degree or third degree, with need to perform surgical debridement. The control group~     will be constituted by patients with less than 5% of TBSA, deep second-degree or third~     degree, with need to perform surgical debridement. The authors will evaluate the levels of~     IL-1ß, IL-6, IL-8, IL-10, IL-12p70 and tumor necrosis factor alpha (TNF-alfa) in samples of~     the culture media of primary dermal fibroblasts of patients selected using flow cytometry.~     The level of keratinocyte growth factor (KGF), in the same samples will be evaluated by~     ELISA. The keratinocyte growth factor (KGF) and TNF-alfa gene expression will be evaluated in~     the culture of primary dermal fibroblasts from the same patients. The gene expression of KGF~     and cytokines will be done by qRT-PCR and RT-PCR array. The experiments will be done in~     duplicate.~   "
172884|NCT01302197|"~     Stroke, a leading cause of disability in the aging population, increases the risk for~     diabetes, subsequent stroke recurrence, and cardiovascular disease complications. The~     downsizing of private and federal health care resources, along with the anticipated increase~     in stroke rates as our population ages, mandate that alternative strategies be developed to~     reduce the public health burden of stroke. This pilot study may facilitate our knowledge of~     the timing of paretic leg muscle atrophy, fiber type shift, and the progression of worsening~     of glucose tolerance after stroke. Knowledge of the skeletal muscle changes occurring in the~     sub-acute stroke period is essential to create new guidelines incorporating exercise~     rehabilitation, much like cardiac rehabilitation, in order to facilitate and improve the~     health care of veteran stroke survivors.~   "
172885|NCT01302184|"~     Gait rehabilitation with treadmill has been reported to be useful in patients with~     Parkinson's disease. In the last years, interest in robotic devices for gait training has~     grew up for patients with different neurological disorders, since they minimize demands on~     physical therapists and may provide a more reliable and constant treatment.~      The aim of this study is to evaluate if robotic gait training with Lokomat® can improve~     walking more than conventional gait training with treadmill in patients affected by~     Parkinson's disease.~   "
172886|NCT01302171|"~     A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary~     injection of progenitor cells compared to placebo injection in patients with Dilated~     Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and~     patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo~     injection~   "
172887|NCT01302158|"~     A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of~     glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics,~     safety and pharmacodynamics of ASP1941 (Part B).~   "
172888|NCT01302145|"~     A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when~     ASP1941 is administered as add-on therapy to metformin.~   "
172889|NCT01302132|"~     This study investigates the pharmacokinetics, in particular the routes and extent of~     metabolism and excretion, of ASP1941 after a single oral dose.~   "
172890|NCT01302119|"~     The purpose of this study is to determine whether AN2690 topical solution is a safe and~     effective treatment for onychomycosis of the toenail.~   "
172891|NCT01302106|"~     This is an interventional, multicenter, open label, phase II study designed to evaluate the~     safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated~     patients with poor risk of Myelodisplastic Syndromes.~   "
172892|NCT01302093|"~     This study is designed to assess bioequivalence between two products used for treatment of~     acute diarrhea.~   "
172893|NCT01302080|"~     To evaluate the long-term impact of treatment with sertraline on aspects of cognitive,~     emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16~     years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive~     compulsive disorder.~   "
172894|NCT01302067|"~     This study is designed to confirm if 8mg of fesoterodine is more effective in reducing~     overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to~     assess if the higher dose reduces the overall effect of overactive bladder on the subject's~     daily life more than the lower dose. The study also assesses the side effects and safety of~     the two doses.~   "
172895|NCT01302054|"~     Patients with overactive bladder are often treated with tolterodine, a medication that helps~     relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes~     patients do not have a satisfactory response, and may benefit from trying an alternative oral~     medicine. Fesoterodine is related to tolterodine by producing the same active substance that~     acts on the bladder, but potentially at higher and more effective levels. So, a patient who~     has a poor response to tolterodine may still obtain a good response to fesoterodine. This~     study will help find out if this is what happens.~   "
172896|NCT01302041|"~     To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with~     prostate cancer.~   "
172897|NCT01302028|"~     A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes~     Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients~     with normal renal function and healthy volunteers.~   "
172898|NCT01302015|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     Buerger's disease.~   "
172899|NCT01302002|"~     The study will test metformin in patients with early breast cancer. Blood and tissue will be~     collected before and after the use of metformin.~   "
172900|NCT01301989|"~     Inadequate sleep is a major health problem of childhood that often fails to receive attention~     until significant neurobehavioral and other health problems are noted. Although adequate~     sleep is essential for normal growth and brain development, studies show that children from~     minority and economically disadvantaged families are more likely to experience shorter sleep~     times and more sleep fragmentation compared to their Caucasian and economically advantaged~     counterparts. As a result, they are disproportionately affected by the adverse health and~     quality of life consequences of poor sleep. There are currently no intervention studies to~     the investigators knowledge aimed at addressing sleep disparities by improving sleep duration~     and sleep hygiene in early school-aged children from minority populations. This study seeks~     to close the 'sleep gap' that exists between the sleep duration of minority school-aged~     children and that of their non-minority peers. An interdisciplinary team of researchers and~     clinicians from Columbia University's Pediatric Lung and Sleep Disorders Center, School of~     Public Health, Psychiatry Department, and two outpatient clinic systems affiliated with~     Columbia are collaborating to reduce sleep disparities by improving sleep duration in a group~     of 5-6 year old minority children. The primary goal of this study is to evaluate the efficacy~     of a tailored, interactive, educational and behavioral intervention that utilizes trained~     sleep counselors to assist parents in improving their children's sleep hygiene and reducing~     risk factors for poor sleep, thereby increasing sleep duration over a 12-month period in a~     randomized controlled trial of children identified with sleep problems (Aim 1). The~     investigators will screen 375 parents of 5-6 year old children from 5 primary care clinics to~     identify children with and without sleep problems and enroll 90 of the 375 children screened~     who have sleep problems in a randomized controlled trial of an in-home sleep intervention.~     Using an initial home assessment, baseline actigraphy data, sleep logs recorded by parents,~     and information regarding risk factors for poor sleep collected from each family during~     screening, the investigators will work with intervention parents to develop a personalized~     sleep plan for their children. The investigators will evaluate the effect of the intervention~     on: a) nightly sleep duration; b) neurocognitive function; and c) behavioral disorders.~   "
172901|NCT01301976|"~     The purpose of this study is to determine the reason patients are deficient in nutrients~     intake such as antioxidants vitamins.~   "
173231|NCT01297608|"~     This is a double blinded cross over study. Approximately 20 spinal cord injury patients will~     be participating in this 4 weeks study.The primary outcome is difference in fecal~     incontinence as recorded in diaries, between the treatment period and the treatment period.~   "
172902|NCT01301963|"~     This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating~     patients with multiple myeloma (MM) previously treated with lenalidomide. Giving~     colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the~     patient's bone marrow to the blood so they can be collected and stored~   "
172903|NCT01301950|"~     This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions~     surgical technique compared to conventional surgical technique. Specifically, the purpose of~     this study is to collect time data to enhance the existing economic model.~   "
172904|NCT01301937|"~     Phase III clinical trial for mucosal or mucocutaneous leishmaniasis. Equivalence between the~     standard and alternative schemes with meglumine antimoniate has begun in October 2008 at the~     Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical Research Institute~     (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard recommended schedule~     with an alternative regimen of meglumine antimoniate (MA) in the treatment of mucosal or~     mucocutaneous leishmaniasis (ML or MCL)). It is a study with blind evaluation by the doctors~     and the responsible for statistical analysis. Patients diagnosed with Ml or MCL, eligible for~     the trial, are randomly allocated into one of the schemes with meglumine antimoniate and~     monitored before, during and after it. There is no single regimen applicable to all forms of~     leishmaniasis around the world. Therapeutic regimens applied to treat people living in other~     geographic areas result in mixed outcomes. Ideally, the most appropriate regimens should be~     established for each endemic area, based on its efficacy, toxicity, difficulties of~     administration and cost. Given the problems and limitations of the use of pentavalent~     antimonials at 20 mg / kg / day, a less toxic alternative regimen with 5mg/kg/day, continuous~     up to the cure deserves to be better evaluated. Treatment must lead to the healing of mucosal~     lesions and prevent late scarring tissues and disabilities development. The indication of~     high doses of MA is based on the evidence that there could be induction of resistance with~     use of subdoses. However, clinical studies with extended follow-up in Rio de Janeiro have~     suggested that regular low MA doses (5mg / kg / day) in a systemic way may constitute an~     effective scheme, achieving cure rates similar to higher dose, with lower toxicity, ease of~     implementation and lower cost. Published studies on efficacy and safety of alternative~     schemes with meglumine antimoniate failed to provide conclusive results, for various~     methodological biases. The need to compare the effectiveness and safety between treatment~     schemes with meglumine antimoniate currently recommended in Brazil for the treatment of ML or~     MCL and an alternative scheme with low dose of antimony is the motive for this study in Rio~     de Janeiro.~   "
172905|NCT01301924|"~     Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and~     Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis  has begun~     in October 2008 at the Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical~     Research Institute (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard~     recommended schedule with an alternative dosage scheme of meglumine antimoniate in the~     treatment of American tegumentary leishmaniasis (ATL). It is a study with blind evaluation by~     the doctors and the responsible for statistical analysis. Patients diagnosed with ATL,~     eligible for the trial are randomly allocated into one of the schemes with meglumine~     antimoniate and monitored before, during and after it. There is no single regimen applicable~     to all forms of leishmaniasis around the world. Therapeutic regimens applied to treat people~     living in other geographic areas result in mixed outcomes. Ideally, the most appropriate~     regimens should be established for each endemic area, based on its efficacy, toxicity,~     difficulties of administration and cost. Given the problems and limitations of the use of~     pentavalent antimonials (Sb5+) at 20 mg Sb5+ / kg / day, less toxic alternative regimens,~     i.e. 5mg Sb5+/kg/day, deserve to be better evaluated. The treatment of ATL must heal skin~     lesions and prevent late mucosal lesion development. The indication of high doses of Sb5+ is~     based on the evidence that there could be induction of resistance with use of subdoses.~     However, clinical studies with extended follow-up in Rio de Janeiro have suggested that~     regular low doses (5mg Sb5+ / kg / day) may constitute an effective scheme, achieving cure~     rates similar to higher doses, with lower toxicity, ease of implementation and lower cost.~     Published studies on efficacy and safety of alternative dosage schemes with meglumine~     antimoniate failed to provide conclusive results so far, for various methodological biases.~     The need to compare the effectiveness and safety between the standard treatment scheme with~     meglumine antimoniate currently recommended in Brazil for the treatment of ATL and an~     alternative scheme with low doses of antimony is the motive for this study in Rio de Janeiro.~   "
172906|NCT01301911|"~     Cipatinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This~     study is designed to evaluate the safety and tolerability of cipatinib in patients with HER2~     positive or uncertain advanced breast cancer:~        1. To evaluate the safety and tolerability of cipatinib, and the maximum tolerated dose~          (MTD) and dose-limiting toxicity (DLT)~        2. To determine the pharmacokinetic profile of cipatinib and its metabolites~        3. To assess preliminary antitumor activity~        4. To determine preliminary regimen for phase II study~        5. To determine the relation of expression of HER-1 and HER-2 to the antitumor activity.~   "
172907|NCT01301898|"~     The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human~     iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients~   "
172908|NCT01301885|"~     Endometriosis is a chronic disease characterized by the presence of functional endometrial~     glands and stroma in ectopic locations outside the uterine cavity. The ectopic endometrial~     tissue responds to estradiol and other hormones similarly to the normal endometrium.~     Endometriosis is one of the most common benign gynecological conditions, as many as 5-10% of~     women in the reproductive age may be affected. In addition to pain which may be severe,~     subfertility is one of the typical problems associated with endometriosis and may be present~     in up to 40% of those affected. There is lack of a clear correlation between severity of pain~     and degree of compromised fertility. Different modes of treatment exist. Hormonal treatments~     are based on the suppression of estrogenic action on endometriosis as well as the~     endometrium. Unfortunately, discontinuation of the hormonal treatment typically results in a~     rapid recurrence of the disease. Surgery may alleviate the symptom for different lengths of~     time, however, curative treatment frequently involves hysterectomy with bilateral~     oophorectomy. In order to escape this radical treatment, new targeted therapy in the form of~     novel pharmacological agents would be of crucial importance. Presently, endometriosis can be~     reliably diagnosed only by laparoscopy. Since this is an invasive surgical procedure, new~     diagnostic tools would be warmly welcomed. Furthermore, as the progression of the disease is~     presently impossible to predict, new markers for the malignancy of each case are~     desperately needed.~      The aim of the investigators research is to identify expression of endometriosis specific~     RNAs/proteins. Evaluation of expression profiles in samples of endometriosis and endometrium~     of patients with careful clinical and surgical classification of endometriosis as well as~     healthy control women should initially enable to identify novel targets for new therapies and~     biomarkers. Furthermore, combined with an adequate follow up, the study should enable for~     example to identify markers for endometriosis associated infertility as well as cases where~     the disease progresses very rapidly. Different forms of effective treatment may thereafter be~     designed following the identification of such factors.~   "
172922|NCT01301703|"~     Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent~     B. pertussis infection between 8%--26% have been reported among adults with cough illness of~     at least 5 days duration who sought medical care. The CDC recommends vaccinating patients~     aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have~     been evaluated in healthy population, the safety and efficacy of this vaccine in patients~     suffering from rheumatic diseases have not been established.~      Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls~      Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of~     safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood~     will be drawn at each visit at tested for humoral response to tetanus and pertussis.~   "
173016|NCT01300455|"~     This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant~     (MK-4305) on respiratory function in participants with mild to moderate obstructive sleep~     apnea (OSA) compared to administration of placebo. The primary hypothesis of this study is~     that multiple doses of MK-4305 do not produce a clinically significant increase in~     Apnea-Hypopnea Index (AHI) in participants with mild to moderate OSA, as compared to placebo.~   "
172909|NCT01301872|"~     During the past two decades, there current concept has evolved significantly that~     ventilator-induced lung injury (VILI) may not only impose a direct mechanical stress and~     subsequent injury to the lungs, but may also induce local as well as systemic inflammation~     responses, generally referred as biotrauma.1 Patients with ARDS often die of severe systemic~     inflammatory response syndrome (SIRS) and multiorgan dysfunction2 rather than refractory~     hypoxemia. Ranieri et al found that patients with less severe ARDS, i.e., a lung injury score~     of 2.5 or less, receiving ventilation with lung protective strategy involving low tidal~     volume (7.5 mL/kg PBW) and high PEEP could attenuate the pulmonary and systemic cytokine~     response compared with conventional ventilation with high tidal volume.3 Stuber et al found~     an increase in pro-inflammatory cytokines in the lung and plasma of patients with ARDS within~     1 hour after switching the patients from a protective to non-protective ventilator strategy.4~     The receptor for advanced glycation end-products (RAGE) was recently identified as a marker~     of injury to the alveolar type I epithelial cells5. Clinical studies showed that the plasma~     level of RAGE was associated with severity of lung injury and clinical outcome, and low tidal~     volume strategy ventilation accelerated the decline in plasma RAGE levels. These results~     suggest plasma RAGE level might be a reliable biomarker of alveolar epithelial injury in~     acute lung injury and may associated with ventilator induced lung injury6. Although, current~     approach to mechanical ventilation of a patient with ARDS emphasizes the use of lower tidal~     volumes with lower plateau pressures to avoid causing lung overdistension and ventilator~     associated lung injury (VILI)7; however, in the real world, some studies showed that strictly~     reduction of tidal volume to 6ml/kg PBW was modest in modern time, and was noticed only in~     patients with greater lung injury scores8. The benefit of VT strictly reduction to 6ml/kgPBW~     and its effect on VILI in patients with less severe ARDS whose Pplat are already below 30~     cmH2O are controversy9. One of the possible solutions is to look at the biomarkers of injury~     to alveolar epithelial cells. Of these potentially promising markers, the receptor for~     advanced glycation end-product (RAGE) is of great interest.~      We hypothesize that a strategy with strict low tidal volume in less severe ARDS and ALI~     patients with good compliance may be beneficial to this patient population. Therefore, we~     wish to propose a prospective single-center study to investigate the effect of mechanical~     ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute~     lung injury.~   "
172910|NCT01301859|"~     The study is a randomized controlled trial to test the usefulness of a brief intervention to~     improve adherence to antidepressant medication prescribed to older adults in a primary care~     setting. Study will be conducted at Weill Cornell and University of Michigan.~   "
172911|NCT01301846|"~     To explore the relationship between ability to do different wheelchair skills and the~     participation and quality of life of wheelchair users in and around their home and community.~     The investigators study hypothesis:~        1. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is~          strongly related to self-reported participation.~        2. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is related~          to the average daily distance traveled in their wheelchair.~   "
172912|NCT01301833|"~     The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as~     monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2~     Diabetes for 52 weeks administration.~   "
172913|NCT01301820|"~     Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of a~     Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit~     Patients With Poor Prognosis Acute Myeloid Leukemia (AML).~      The disease-free survival (DFS) of the patients included in this study will be compared to~     the ones of the two previously reported groups of patients treated with the same LIA~     induction therapy~   "
172914|NCT01301807|"~     The goal of this clinical research study is to find the highest tolerable dose levels of~     carfilzomib and LBH589 (panobinostat) that can be given in combination to patients with~     myeloma. The safety of this drug combination will also be studied.~   "
172915|NCT01301794|"~     High levels of triglycerides is a common abnormality found in patients with diabetes and also~     cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids, as~     found enriched in fish and also in the commercial agent called Lovaza lower triglyceride~     levels. Prior work from the investigators group demonstrated that an enzyme responsible for~     the break down of triglycerides - lipoprotein lipase - generates molecules that can activate~     a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that~     taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins~     and increases the ability of those lipoproteins to activate PPAR-alpha.~   "
172916|NCT01301781|"~     A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated~     adults.~   "
172917|NCT01301768|"~     The purpose of this study is to assess the effectiveness of individual education versus group~     education about dietary habits and iodine supplementation to decrease iodine deficiency in~     pregnant women~   "
172918|NCT01301755|"~     Invasive aspergillosis is a serious and often fatal infection in patients who are neutropenic~     or have undergone solid organ or stem cell transplantation. However, early diagnosis of~     invasive aspergillosis is a challenge. Reiss and Lehmann first described the value of serum~     Galactomanna (GM) for diagnosis of invasive pulmonary aspergillosis in 1979. The availability~     of the Platelia Aspergillus, a sandwich ELISA that has been approved by FDA in 2003 for~     managing patients at risk of invasive aspergillosis because of the early detection of the GM~     antigen. In several studies so far the specificity of the serum galactomannan assay was~     greater than 85%; however, variable sensitivity from 29~100% was noted over years. In~     addition, low values and false-negative results are seen more often in nonneutropenic and~     solid organ transplantation patients as opposed to severely granulocytopenic patients .There~     are several factors that might explain the reported difference in the performance of antigen~     detection, including the biological factors and epidemiological factors.~      In recent years, specimens of other body fluids are increasingly used for detection of~     Aspergillus galactomannan antigen, including urine, bronchoalveolar lavage(BAL) fluid,~     cerebrospinal fluid and even the tissue specimen. However, the sensitivity and specificity of~     the GM detection in various specimens still have considerably variation. Ultrasound-guided~     transthoracic aspirate is a safe and useful method for collecting specimens for accurate~     bacteriologic diagnosis of lung abscess and obstructive pneumonitis10. We also reported a~     study of diagnosis of pulmonary Cryptococosis by ultrasound guided percutaneous aspiration.~     We plan to perform a prospective single-center study to investigate the role of GM in the~     target organ (lung tissue/fluid) by using ultrasound-guided fine needle aspirate for early~     diagnosis invasive aspergillosis compared with the serum galactomannan.~   "
172919|NCT01301742|"~     To investigate the relative bioavailability of BI 10773 following coadministration with 600~     mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.~   "
172920|NCT01301729|"~     This single arm, open-label study will evaluate the efficacy and safety of Herceptin~     (trastuzumab) in combination with a taxane as first line therapy in participants with~     HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment.~     Participants will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv~     weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or~     paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease~     progression or unacceptable toxicity occurs.~   "
172921|NCT01301716|"~     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and~     carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with~     locally advanced or metastatic solid tumors.~   "
172974|NCT01301014|"~     This study is investigating the reliability and diagnostic accuracy of a Lachman's test~     conducted in a prone position to detect the presence of a torn anterior cruciate ligament.~   "
172923|NCT01301690|"~     3,6-bis(1-methyl-4-vinylpyridinium) carbazole diiodide (BMVC) is an inorganic chemical~     compound (Figure1). The uptake of BMVC in cancer cells and normal cells are different.~     Recently, a simple handheld device (Figure1) based on the fluorescence analysis of stained~     cells was established to instantly differentiate cancer cells from normal cells. The~     investigators want to quantitatively measure the fluorescence expression of BMVC in normal~     and cancer cells and explore the usefulness of this staining in head and neck lumps.~   "
172924|NCT01301677|"~     Double blinded (subject and observer), randomised, active (hydrocortisone (HC)) controlled~     study of the effect of strontium chloride hexahydrate on ultraviolet B radiation (UVR)~     induced signs of inflammation (erythema and pain) in healthy volunteers.~   "
172925|NCT01301664|"~     In this study, the investigators explored the hypothesis that osteoarthritic cartilage~     fragments can promote chondrogenesis of MSCs. Non-wearing parts of cartilage tissues were~     harvested from one osteoarthritic patient during the total knee arthroplasty surgery.~     Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were implanted~     subcutaneously into nude mice.~      Moreover, the investigators will collect the discard cartilage to develop an acellular~     cartilage ECM-derived scaffold in the joint replacement surgery. In addition, the~     investigators will harvest the redundant bone marrow from drilling or useless synovium during~     the surgery to separate the mesenchymal stem cells. Furthermore, these mesenchymal stem cells~     will be transfected with hTERT for rejuvenation and then will be labeled with fluorescent dye~     PKH26 for application of animal study. To sum up, the investigators plan to use human,~     natural, and discard materials from the joint replacement surgery to develop appropriate~     allograft for cartilage repair and hope that one day this ideal would be apply in clinical.~   "
172926|NCT01301651|"~     Background and Objective: Postural instability is common in patient with Parkinson's disease~     (PD). The purpose of this study was to investigate the effects of virtual reality (VR)~     balance training on sensory and cognitive domains of postural control.~      Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and Yahr~     stage II-III) were recruited and assigned into three groups randomly.~      Intervention: Participants in the virtual reality (VR) group and conventional balance~     training (CB) group received a 6 weeks balance training program. The control group (CG) did~     not receive any training.~      Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography~     with single and dual tasks (i.e. with backward subtraction of number) were examined pre-,~     post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The~     verbal reaction time (VRT) was recorded.~      Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at visual~     and somatosensory conflicting condition) post-training more than CG post-training in either~     single or dual task. (2) Only CB training significantly increased SOT-5 (i.e., vestibular~     function without visual conflict) and vestibular sensory ratio (i.e., SOT-5/SOT-1) more than~     CG post-training in either single or dual task. (3) (3) Neither VR nor CB training reduced~     VRT significantly under six sensory conditions at post-training and follow-up.~      Conclusion: Both VR training and CB training can improve sensory organization for postural~     control by enhancing utilization of vestibular information, but VR could enhance vestibular~     function with conflicting proprioceptive and visual information under single and dual tasks~     in patients with mild to moderate PD.~   "
172927|NCT01301638|"~     Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale~     clinical trials conducted that included more than 1,000 subjects and than Daptomycin got~     complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got~     new indications about bacteremia and endocarditis due to success outcomes in the clinical~     trial which included infected in blood flow and endocardial infected patients.~      All subjects in Daptomycin clinical trials are European and American race. It is necessary~     that collecting safety and efficacy data of Daptomycin in Taiwan race. I will intent to~     evaluate the safety and efficacy of Daptomycin which were used in patients with serious~     gram-positive infections retrospectively. And the outcome could be a reference for Daptomycin~     future using.~   "
172928|NCT01301625|"~     The primary objective of the MitraClip System ANZ Clinical Trial is to gather real-world~     clinical and health-economic outcome data to support the long-term safety, efficacy and~     economic value of the MitraClip System in the continuum of therapies for treating MR.~     Specifically, the following clinical and economic data will be collected: New York Heart~     Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life~     (QOL) information, echocardiographic measures of left ventricular size and function, and data~     associated with the index hospitalization, rehospitalizations, concomitant medications and~     discharge facility to support the MitraClip System economic analysis.~   "
172929|NCT01301612|"~     The primary study objective will be to assess the efficacy of the combination of radiation~     therapy with nimotuzumab and cisplatin, as compared to the combination of radiation therapy~     plus cisplatin in the treatment of Uterine Cervical Carcinoma (UCC).~      The secondary study objectives will be safety and tolerability evaluations, to determine~     treatment feasibility and the interim efficacy evaluation according to other parameters~     routinely used in oncology.~   "
172930|NCT01301599|"~     This study is designed to investigate the comparison between alpha blocker monotherapy and~     5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic~     hyperplasia.~   "
172931|NCT01301586|"~     The purpose of this study is to evaluate a novel, combination product for the treatment of~     acne vulgaris in females~   "
172932|NCT01301573|"~     The purpose of this observational study is the long term follow-up of Parkinson's patients~     who participated in a clinical trial in which they received AAV-GAD gene transfer into the~     subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up~     to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and~     provide long term safety information.~   "
172933|NCT01301560|"~     The need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non~     small cell lung cancer (NSCLC).~      Therefore, the investigators do a randomized study comparing overall survival between two~     groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative~     chemotherapy for NSCLC.~   "
173264|NCT01297166|"~     The purpose of this study is to evaluate the anti-psoriatic effect of LEO 27989 ointment and~     calcipotriol plus LEO 27989 ointment, using the psoriasis plaque test modified from the~     method developed by KJ Dumas and JR Scholtz.~   "
172934|NCT01301534|"~     Standard of care dictates that eligible patients should receive an abdominal aortic aneurysm~     (AAA) screening ultrasound. At present, different military primary care physicians utilize~     different methods at their discretion to ensure their patients get screened—telephone~     contact; mail-out reminders; referring patients for ultrasound directly from an office visit;~     as well as other methods—which we will refer to as usual care. The purpose of this study is~     to improve screening rates for AAA and determine what notification methods are best at~     improving screening rates.~   "
172935|NCT01301521|"~     The purpose of this study is to assess whether water-soluble cinnamon extract plus aggressive~     lifestyle intervention is effective in lowering blood glucose in pre-diabetic patients when~     compared to aggressive lifestyle therapy plus placebo.~   "
172936|NCT01301508|"~     The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and~     effective treatments for mild-to-moderate atopic dermatitis (AD).~   "
172937|NCT01301495|"~     In this study, a newly designed and FDA approved fully covered metal stents will be used to~     palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed~     before and after treatment to confirm efficacy~   "
172938|NCT01301482|"~     The purpose of this study is to assess the effect of ear acupuncture alone in subjects with a~     contraindication to anti-inflammatory medications in the reduction of pain and hours lost~     from work in acute sore throat.~   "
172939|NCT01301469|"~     The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte~     infusion in comparison to HES 130/0.4 in a sodium chloride infusion.~   "
172940|NCT01301456|"~     The primary objective of this study is to evaluate the safety and tolerability of PF-04856883~     (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.~   "
172941|NCT01301443|"~     The purpose of this first in man study is to examine the safety of an experimental gene~     transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration.~   "
172942|NCT01301430|"~     Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects~     suffering from glioblastoma multiforme.~   "
172943|NCT01301417|"~     The proposed study is a post marketing, observational, retrospective data collection intended~     to gather and record data on patients treated with the ColonRing™ device in routine clinical~     practice at a single center. The data will assist in further evaluating the performance of~     the ColonRing™ device in regards to the creation of a colorectal anastomosis.~      Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will~     be within the acceptable range reported in the literature for alternative treatment~     modalities.~   "
172944|NCT01301404|"~     PONV after intrathecal morphine, occurs up to 30-40 percent. The patients having TKR normally~     are female, obese and non-smoker which are risk factors for PONV. Recently, a multimodal~     approach, combining several means to minimize PONV, has found wide acceptance as a standard~     of care. In our hospital, most of the patients are supposed to fast after midnight The oral~     rehydration therapy reduce patients thirst and increase his satisfaction, but whether or not~     this method can reduce the incidence of PONV after low dose (0.2 mg) intrathecal morphine is~     not investigated yet. The aim of this study is to investigate the effect of preoperative oral~     rehydration therapy on the incidence of PONV.~   "
172945|NCT01301391|"~     The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with~     recurrent or metastatic, unresectable malignant thymoma previously treated with multiple~     lines of chemotherapy.~   "
172946|NCT01301378|"~     The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the~     Molteno 3 glaucoma drainage device during surgery~   "
172947|NCT01301365|"~     The aim of this study is to check whether patients with cystoscopic findings supporting the~     diagnosis of Interstitial Cystitis (IC) have a higher autonomic response (change in blood~     pressure / pulse)than patients without cystoscopic findings.~   "
172948|NCT01301352|"~     The investigators are studying whether it is safe and effective to provide enteral nutrition~     to critically ill children via the nasogastric route, as opposed to the nasojejunal route,~     while they are receiving noninvasive positive pressure ventilation.~   "
172949|NCT01301339|"~     The purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among~     those Air Force personnel who have not passed the Air Force physical fitness test (AFPT) and~     to evaluate the usefulness of the AFPT as a prescreening tool for these disease processes.~   "
172950|NCT01301326|"~     Best treatment option of retinal arterial macroaneurysm is still controversial. A recent~     publication has shown that subthreshold laser treatment can be beneficial in improving visual~     acuity in eyes with symptomatic retinal arterial macroaneurysm. Aim of the study is to~     compare the effects of subthreshold laser treatment and threshold laser treatment in patients~     affected by symptomatic retinal arterial macroaneurysm.~   "
172951|NCT01301313|"~     To evaluate the efficacy and safety of levosimendan versus conventional intensified inotropic~     treatment, in critical children with severe acute heart failure which persists despite of~     having received conventional inotropic treatment.~   "
172952|NCT01301300|"~     Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™~     provides passive disinfection of valve top and threads without activating the luer access~     valve. This product promotes technique standardization and compliance in cleansing of the~     luer access valve prior to access. It acts as a physical barrier from touch and airborne~     contamination for up to 96 hours. This product has been endorsed and will be adopted for use~     at NorthShore University HealthSystem as a quality improvement initiative. This research~     study protocol is designed to confirm the anticipated benefit of this change in practice at~     NorthShore during the planned implementation and use.~      If the product performs as it has been designed to, the baseline rate of hub and subsequently~     intraluminal contamination will be diminished, thereby protecting patients with central lines~     from bloodstream infections due to contaminated hubs.~   "
172975|NCT01301001|"~     The Specific aims of this project are to (1) test the prediction that pain from tampon~     insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin~     compared to when treated with placebo. Secondary outcome measures include intercourse pain~     and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and~     to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more~     specific treatment options.~   "
172953|NCT01301287|"~     Chlorella, a type of unicellular fresh water algae, has been a popular foodstuff in Asia,~     especially in Taiwan. Recent studies have shown the hypoglycemic effects of Chlorella through~     increasing glucose uptake in the liver and muscle, lowering serum free fatty acid levels, or~     activation of PPAR gamma receptor. However, the hypoglycemic effect in diabetic patients have~     not been studied. In order to clarify the hypoglycemic effects and mechanism of Chlorella in~     diabetic patients, the investigators conducted a 12-week randomized, double-blind,~     placebo-control trial on diabetic patients.~   "
172954|NCT01301274|"~     The primary objective of this study is to compare the mean serum sodium after 48 hours of~     therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill~     children requiring IV maintenance fluid administration.~   "
172955|NCT01301261|"~     Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular~     blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to~     the reversal of the neuromuscular block. The aim of the study was to investigate the pure~     effects of sugammadex in the absence of the agonist.~   "
172956|NCT01301248|"~     To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further~     addition of cetuximab experimental treatment~   "
172957|NCT01301235|"~     This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects~     with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal~     variable(s) to represent mitochondrial function.~   "
172958|NCT01301222|"~     This randomized controlled trial (RCT) aims at assessing the influence of octreotide on~     pancreatic fistula or complications following pancreatoduodenectomy in patients with soft~     pancreas. Previously reported trials have included all types of pancreatic resections and~     have include all types of pancreas and have shown no clearcut benefit of octreotide after~     pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for~     fistula following PD. This study's focus is on this select group of patients and aims to~     assess the role of octreotide in patients with soft pancreas.~   "
172959|NCT01301209|"~     Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of~     ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal~     disease.~   "
172960|NCT01301196|"~     Excessive periods of time spent sitting may be a risk factor for diabetes. Current lifestyles~     encourage large amounts of sitting (sedentary behaviour) through increasing car use,~     computers, and appealing screen-based home entertainment systems. Methods to help change such~     behaviours are now needed, particularly for those with a high risk of developing a chronic~     disease, such as diabetes. The investigators propose to decrease sedentary behaviour in a~     multi-ethnic group of young adults at risk of diabetes through an educational intervention~     (attending a workshop and having prompts). If successful, this could have significant public~     health benefits given the widespread nature of sedentary behaviour.~   "
172961|NCT01301183|"~     Teenage girls with anorexia nervosa (AN) are at risk for low bone density and low rates of~     bone accrual, raising concerns regarding acquisition of peak bone mass, an important~     determinant of future bone health and fracture risk. Important factors contributing to low~     bone density in AN include low levels of estrogen and insulin like growth factor-1 (IGF-1).~     While estrogen is important for preventing bone loss, IGF-1 is important for optimizing bone~     formation. We have shown in a previous study that replacement of estrogen is effective in~     increasing bone density in teenage girls with AN; however, this increase in bone density~     remains lower than that seen in normal-weight controls over the same duration, and residual~     deficits persist. Importantly, the impact of administering replacement doses of IGF-1 with~     estrogen replacement has not been studied in teenagers with AN.~      This study will examine the impact of administering recombinant human (rh) insulin like~     growth factor-1 (rhIGF-1) with estrogen (to mimic pubertal levels of these hormones) versus~     administration of estrogen alone on bone metabolism in adolescent girls with anorexia nervosa~     (AN).~      One aim of this proposal is to investigate whether co-administration of insulin like growth~     factor-1 (rhIGF-1) with physiologic estradiol replacement to adolescent girls with AN will~     increase BMD (bone mineral density) more than estrogen monotherapy, and whether bone mass~     will approach that seen in healthy adolescent girls. An additional aim is to determine~     whether co-administration of rhIGF-1 with estradiol to mimic the normal pubertal milieu~     stimulates bone formation through an IGF-1 mediated anabolic effect, increases bone density~     to a greater extent than estrogen monotherapy, and improves bone mass accrual to approach~     that in healthy controls. The impact of rhIGF-1 +estradiol versus estradiol alone on bone~     microarchitecture will also be assessed.~   "
172962|NCT01301170|"~     The purpose of this study is to determine whether individuals with neck pain will respond~     favorably to a program of manual therapy, directed at the cervical and thoracic spine~     (including thrust manipulation), and exercise, in combination with dry needling, as compared~     to manual therapy, directed to the cervical and thoracic spine (including thrust~     manipulation), and an exercise program alone.~   "
172963|NCT01301157|"~     This study is to evaluate the efficacy and safety of M518101 and the dose relationship among~     two doses of M518101 and placebo in male and female plaque psoriasis patients.~   "
172964|NCT01301144|"~     Background:~        -  Tuberculosis is a disease of the lungs caused by the bacteria Mycobacterium tuberculosis~          (M. tuberculosis). The most popular and least expensive tool used to detect the presence~          of the tuberculosis bacteria is called sputum smears, which is a lab test used to look~          for bacteria in the sputum via a microscope. However, the test s results are not always~          accurate, and the test cannot determine if the bacteria will be resistant to standard~          tuberculosis treatments. The most sensitive test currently available is called sputum~          culture, in which a sputum sample is used to check for the growth of tuberculosis~          bacteria. However, this test takes at least a month to produce accurate results, and~          requires expensive equipment that is not available in many countries where M.~          tuberculosis is found.~        -  The urea breath test (UBT) has been used to detect infection with Helicobacter pylori, a~          bacteria associated with stomach ulcers, by testing individual breath samples.~          Researchers are interested in determining whether breath samples can also be used to~          detect the presence of M. tuberculosis in the lungs of subjects with tuberculosis, and~          to see if tuberculosis treatments are successful.~      Objectives:~      - To assess the sensitivity and specificity of urea breath testing in the diagnosis and~     treatment response of pulmonary tuberculosis.~      Eligibility:~        -  Individuals at least 18 years of age who either have been diagnosed with tuberculosis or~          are healthy volunteers with no past history of tuberculosis.~        -  The study will be conducted in Bamako, Mali.~      Design:~        -  This study will involve three groups: two pilot groups of individuals who have already~          been diagnosed with tuberculosis, and a primary study group of both healthy volunteers~          and individuals who have been diagnosed with tuberculosis.~        -  Participants will be screened with a physical examination and medical history, as well~          as blood, sputum, stool, and urine samples.~        -  First pilot group (one visit):~        -  Participants should not eat, drink, or smoke for at least 1 hour prior to the UBT test.~        -  Participants will provide a baseline exhaled air sample, and then will receive the UBT~          test, which involves a dose of Pranactin -Citric dissolved in water. Additional exhaled~          air samples will be collected at eight time points (10, 20, 45, 60, 90, 120, 180, and~          240 minutes after the dose).~        -  Second pilot group (one or two visits):~        -  Participants should not eat, drink, or smoke for at least 1 hour prior to the UBT test.~        -  Participants will provide a baseline exhaled air sample, and then will receive the UBT~          test. Half of the participants will receive a dose of bismuth (Pepto-Bismol) prior to~          collection of air samples to see how this affects the results of the UBT test.~          Additional exhaled air samples will be collected at three time points specified by the~          study researchers.~        -  On the following day, participants will return for a second visit to provide three more~          exhaled air samples.~        -  Primary study group (five visits for participants with tuberculosis, two visits for~          healthy volunteers):~        -  All participants will have two visits, following the procedures given for the second~          pilot group. Half will receive a dose of bismuth prior to collection of air samples.~        -  Participants with tuberculosis will have three additional visits (days 6, 10, and 16~          following the first study visit) to provide additional sputum and exhaled air samples to~          monitor the progress of tuberculosis treatment.~   "
172965|NCT01301131|"~     Hospitalized patients with ventilator are randomized to receive fermented dairy product~     containing L. casei shirota or nothing. The main outcome is development of~     ventilator-associated pneumonia (VAP)~   "
173265|NCT01297153|"~     The purpose of this study is to document the safety and efficacy of primary IOL implantation~     in children below 2 years of age undergoing congenital cataract surgery.~   "
172966|NCT01301118|"~     SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS~      INTRODUCTION: Infection is cause of increased morbidity and mortality in burn patients, and~     its control is a major challenge also for skin graft integration. Wound and soft tissue~     infection rates are higher than microbiological diagnosis rates.~      PURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis~     of wounds in burn patients.~      METHODS: This project will be a transversal, prospective, analytical, controlled study in~     humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at~     Federal University of São Paulo from October, 2010 to October, 2011. Data will be collected~     to characterize demographic and clinical aspects. Data analysis will be performed using~     Student's t-test and Friedman analysis of variance.~   "
172967|NCT01301105|"~     The project's objective is to explore the impact of Mindfulness-Based-Stress-Reduction (MBSR)~     on pain regulation, social stress, basic affective and attention functions, and on the brain,~     immune, and endocrine mechanisms that subserve these processes. Specifically, the~     investigators hypothesize that participants undergoing MBSR training will show decreased~     emotional distress on self-report measures, increased sustained attention on a behavioral~     task, decreased stress levels on a social stress test, decreased general psychosocial stress~     as indexed by diurnal salivary cortisol profile, changes in inflammatory response, modulation~     of cellular aging, and different neural patterns in response to thermal pain and aversive~     visual stimuli as indexed by functional Magnetic Resonance Imaging (fMRI).~      To test these hypotheses, the study will recruit 50 participants through the UW-Madison~     Integrative Medicine Program. All participants will be randomly assigned either to an 8-week~     MBSR program or to an 8-week training program in health-enhancement. At the conclusion of the~     study, participants will be invited to participate to the second class should they be~     interested. Participants will complete self-report questionnaires, behavioral tasks, fMRI~     scanning, cortisol sampling, and blood sampling before training begins, after the first~     program ends, and again four months after the first program ends and prior to the second~     program.~      If hypotheses are supported, the study may benefit participants by reducing their~     psychological distress, increasing their well-being, and helping them better manage pain and~     aversive stimuli. There are no other direct benefits to participants. Potential risks~     associated with fMRI include ferromagnetic collision, neurostimulation effects, and~     psychological discomfort. Potential risks to subjects include slight potential discomfort in~     providing saliva samples, discomfort of painful thermal stimulation, stress associated with~     the Trier Social Stress Test, some psychological discomfort from viewing disturbing~     photographs as part of the compassion fMRI study, and breach of confidentiality.~      Consent for the present study will entail both written and verbal descriptions of the~     protocol. Subjects will be informed that their participation is completely voluntary, and~     that they can withdraw at any time.~   "
172968|NCT01301092|"~     LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes~     mellitus. This study will compare the concentrations of LY2189265 using different methods of~     administration: subcutaneous (or SC- an injection just under the skin), intravenous (or IV -~     into a vein in the arm) and intramuscular (IM - into the muscle of the left thigh). The~     purpose of this study is to look at how much of the drug gets into the blood stream and how~     long it takes the body to get rid of it when given by the methods above. The study is divided~     into three parts, Part A, B and C. Volunteers will only be able to participate in one part.~     All Participants in Part A will receive a single IV dose of up to 0.1 milligram (mg).~     Participants in Part B will be given drug twice by IV and an SC injection (1.5 mg). Part B of~     the study will occur after Part A because the dose of IV drug will depend on the results of~     Part A. Part B of the study may not occur if the volunteers in Part A do not tolerate the~     drug. Participants in Part C will also be given drug twice by an SC injection and an IM~     injection, both doses will be 0.75 mg.~   "
172969|NCT01301079|"~     The aim of this study was to determine if the addition of ketamine reduces~     remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL(interleukin)-6~     and IL-8 (inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine).~   "
172970|NCT01301066|"~     A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.~   "
172971|NCT01301053|"~     The investigators believe that there remains a gap in implementing insulin infusions in~     critically ill patients to maximize the benefit and minimize adverse events like episodes of~     hypoglycemia. Based on the published experience with Continuous Glucose Monitor (CGM), the~     investigators believe that it is safe to use in critically ill patients. Furthermore, the~     investigators believe that in combination with a protocol with low risk for hypoglycemia at~     baseline, that CGM can eliminate this risk fully.~      In this study the investigators will:~        1. Study the safety and feasibility of the continuous glucose monitor use in 20 critically~          ill patients for 7 days (the current maximum recommendation for sensor use). Safety data~          will include the rate of significant bleeding (hematoma) or infection (cellulitis) from~          sensor use. Feasibility data will evaluate the amount of missing glucose data over the~          7-day sensor life.~        2. Randomize patients treated with the current UVA intensive care insulin protocol for~          insulin management to the addition of brakes that reduce insulin administration based~          on continuous glucose monitoring data between hourly reference glucose data to prevent~          episodes of hypoglycemia (blood glucose <70 mg/dl) and severe hypoglycemia (blood~          glucose <50 mg/dl). This will serve as pilot data to power a larger study in the future.~   "
172972|NCT01301040|"~     The primary objective is to evaluate the difference in cardiac strain rate evolution in~     elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy~     compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT.~      This study also will compare the serum biomarkers profile during and after the (neo) adjuvant~     CT in both treatment arms, assess whether MRI allows detecting earlier than standard~     echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT, assess~     whether brain PET-CT allows detecting regional functional impairment in patients receiving~     CT, evaluate cognitive function before and after (neo) adjuvant CT in both treatment arms,~     evaluate distress and functional autonomy before and after (neo) adjuvant CT in both~     treatment arms, evaluate psychological state and burden of primary caregivers before and~     after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to~     detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both~     treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate~     the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the~     Framingham risk score for Hard Coronary Heart Disease (10-year risk).~   "
172973|NCT01301027|"~     This is a double blinded randomized clinical trial of pioglitazone vs. placebo in overweight~     or obese, diabetic and non-diabetic hemodialysis patients. This study will examine whether~     pioglitazone modulates adipokine production by adipose tissue in hemodialysis patients and~     whether these changes result in reduction of inflammation, insulin resistance and oxidative~     stress and increase in muscle mass.~      In addition, this study will also examine the associations of adiposity with adipokines and~     the metabolic milieu in hemodialysis patients to better understand the biology of adipocytes~     in uremic milieu.~   "
172976|NCT01300988|"~     The investigators' in vitro data suggest that Neurokinin-1 receptor antagonists like~     aprepitant will decrease the expression of CCR5, an essential co-receptor in the life cycle~     of HIV, in the surface of macrophages and lymphocytes to levels at least similar to those~     observed in patients heterozygous for the CCR5 32 mutation. Together with a direct potential~     antiviral effect this could alter disease progression in patients with HIV infection.~      The investigators' hypothesis is that aprepitant is safe, tolerable and has antiviral~     activity in HIV infected individuals.~      This is randomized, placebo controlled, double blind study to determine the safety and~     antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks~     of aprepitant monotherapy.~      18 HIV infected males and females ≥ 18 years old who have early infection with CD4 cell~     counts ≥ 350 cells/mm3. Subjects will be randomized 1:1 to receive 375 mg of aprepitant~     (Emend®) or placebo.~   "
172977|NCT01300975|"~     Intralesional injection of antimony has been used for L major from Iran with a modest cure~     rate [56%: Asilian 2004]. However, this therapeutic approach has been used for L braziliensis~     from Brazil, with an attractive cure rate after 3 months of 80% [Oliveira-Neto 1997]. Because~     intralesional Sb injections is the local therapy with the best reported cure rate for South~     American L braziliensis disease, the species that causes disease in Bolivia, this pilot study~     of local therapy for bolivian L braziliensis disease will evaluate intralesional Sb therapy.~   "
172978|NCT01300962|"~     This phase I study has been designed to establish the safety, tolerability and maximum~     tolerated dose (MTD) of four separate regimens for patients with metastatic breast cancer:~     dose- escalating BKM120 when combined with capecitabine (Arm A), with capecitabine and~     trastuzumab (Arm C), or with capecitabine and lapatinib (Arm D) and dose- escalating BEZ235~     when combined with capecitabine (Arm B).~   "
172979|NCT01300949|"~     The Spaeth-Richman Contrast Sensitivity (SPARCS) test is a new method of assessing contrast~     sensitivity. The test is performed on any standard computer with internet access. Patients~     will be tested with SPARCS and with the standard Pelli-Robson contrast test.~   "
172980|NCT01300936|"~     The purpose of this study is to measure abdominal wall strength both preoperatively and~     postoperatively in patients undergoing ventral/incisional hernia repairs. The investigators~     hypothesize that abdominal wall strength is improved in hernia repairs that reapproximate the~     rectus musculature to the midline. Abdominal wall strength measurements would be obtained~     utilizing various abdominal strength testing.~   "
172981|NCT01300923|"~     Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS~     is inherited from the carrier parent, most often the mothers. FXS is associated with severe~     interfering behavioral symptoms which include anxiety related symptoms, attention deficit~     hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also~     meet criteria for autistic disorder. The hypothesis of this study is that treatment with~     acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social~     deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate~     the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to~     assess the potential psychophysiological differences between FXS and autism spectrum~     disorders.~   "
172982|NCT01300910|"~     This is a randomized control trial of 400 adult male circumcision procedures with a one to~     one ratio between Shang Ring and the in-country standard surgical technique (forceps guided~     in Kenya and dorsal slit in Zambia).~   "
172983|NCT01300897|"~     Biofeedback therapy improves bowel symptoms and anorectal function in patients with~     dyssynergic defecation, however its mechanism of action is not known. The investigators~     hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering~     cortical processing of information and improving cortically mediated neuromuscular function~     of the gut. However, in order to better understand these mechanisms in patients, the~     investigators need to examine and establish normative data and compare findings with healthy~     subjects. The investigators specific aims are to examine and evaluate the following 40 normal~     subjects; (1) To evaluate the afferent cortical evoked potentials in response to the~     electrical stimulation of the anorectum and (2) To evaluate the corticofugal tracts~     (efferent) by recording the anal and rectal electromyographic responses following noninvasive~     lumbosacral and transcranial magnetic stimulation.~   "
172984|NCT01300884|"~     Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately~     characterizes anorectal anatomy and function in healthy humans; HDM provides comparable~     information regarding the structure and function of the anorectal region, to that obtained~     from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal incontinence~     or constipation.~      Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with~     constipation will be recruited. Because anorectal disorders are more common in women, the~     investigators will recruit approximately 8 men and 12 women in each group. Each subject will~     undergo anorectal manometry, anal ultrasound and high definition manometry.~      Data Analysis: Spearman correlational analysis will be performed to compare the parameters~     listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying~     anatomic sphincter defects will be assessed.~   "
172985|NCT01300871|"~     This is a study to determine the prevalence and severity of alopecia (hair loss) experienced~     by postmenopausal breast cancer patients receiving endocrine therapy including Tamoxifen,~     Letrozole (Femara), Exemestane (Aromasin), or Anastrozole (Arimidex).~   "
172986|NCT01300858|"~     Colorectal cancer may be caused by a build-up of genetic defects, or damaged genes within the~     body's cells. When genes are damaged, the body may be unable to produce a group of proteins,~     called cytokines, used by the immune system to fight cancer and some infections. The~     investigational gene transfer agent EGEN-001 contains the human gene for the cytokine~     interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the~     body to produce cytokines.Therefore Therefore, the purpose of the EGEN-001 therapy is to~     attempt to enhance the body's natural ability to recognize and fight cancer cells.~   "
172987|NCT01300845|"~     In France, the most used humidifying system during oxygen therapy is a non heated device with~     weak efficiency and non-proven clinical benefits. This study aims to assess the lack of~     benefits of non-heated humidification compared to no humidification, as regards to the~     comfort of the patient receiving oxygen therapy.~   "
173287|NCT01296867|"~     To study the postoperative results in myopic and hyperopic eyes treated with two different~     laser ablation algorithms (STD and F-CAT), both FDA approved.~   "
172988|NCT01300832|"~     The study's hypothesis is that there are some patients who come for surgery who have~     asymptomatic clots in their lower extremities upon their arrival to the hospital for their~     surgical admission. We will be performing duplex studies of the subjects' legs before their~     surgery to determine how often clots are present. We will also perform duplex scans of the~     legs after the subjects' surgeries to determine what factors (surgical, anesthetic,~     co-morbidities)are correlated with the development of DVTs.~   "
172989|NCT01300819|"~     The primary objective of this study was to demonstrate that Rotigotine improves non-motor~     symptoms compared to Placebo in subjects with Parkinson's Disease.~   "
172990|NCT01300806|"~     The goal of this research is to assess the impact of the screening, brief intervention, and~     referral to treatment (SBIRT) intervention strategy for harmful substance use among~     HIV-positive people.~   "
172991|NCT01300793|"~     Primary objective of the study is to determine the maximum tolerated dose (MTD) of bortezomib~     (Velcade) in combination with rituximab, ifosfamide, carboplatin and etoposide for adult~     patients with relapsed or refractory aggressive B-cell lymphoma. The secondary objectives are~     to assess the tolerability and safety, the response rate, rate of autologous stem cell~     transplant and CD34+ progenitor cell collection and engraftment after treatment with this~     regimen.~   "
172992|NCT01300780|"~     Perhaps the use of a more selective anti-inflammatory drug, capable of inhibiting enzyme~     specific for pain may be more effective in preventing the tooth sensitivity caused by the~     inflammatory response produced by in-office bleaching. To the extent of the authors´~     knowledge, no study has so far addressed the use of a selective anti-inflammatory drug~     specific for pain enzyme on tooth sensitivity, being this the aim of the present~     investigation.~   "
172993|NCT01300767|"~     The purpose of this study is to compare the performance of two commercially marketed contact~     lenses when worn for up to 4 weeks in a daily wear modality.~   "
172994|NCT01300754|"~     Objective: To examine the potential of dextrose injection versus lidocaine injection versus~     supervised usual care to change pain/function/activity levels in adolescent athletes with~     Osgood-Schlatter Disease (OSD).~   "
172995|NCT01300741|"~     The purpose of this study is to compare the performance of two commercially marketed contact~     lenses when worn for up to one month in a daily wear modality.~   "
172996|NCT01300728|"~     Patients with mild cognitive impairment (MCI) are a group recognized at being at high risk of~     progressing to Alzheimer disease. Treatment of MCI with immunotherapy with intravenous~     immunoglobulins (IVIG) could potentially reduce the risk of progression to Alzheimer disease.~      This study will evaluate the efficacy of intravenous immunoglobulin in patients with MCI over~     24 months after the first infusion. This study will also document conversion from MCI to~     Alzheimer's Disease.~   "
172997|NCT01300715|"~     In spite that variable techniques for lumbar MBRF exists, the tunnel vision technique is~     widely recommended for exact radiofrequency needle placement. However, this method uses the~     concept of a steep caudocephalad axial tilt of the fluoroscopy beam, which result in unusual~     appearance of vertebral structures and a long distance from skin to the target site. In our~     institution, therefore, the investigators have used a modified method that is easy and safe~     to place RF needle parallel to the lumbar medial branch in oblique fluoroscopic view.~      Accordingly, our objectives were to evaluate our modified technique for lumbar MBRF,~     comparing with the tunnel vision technique, and additionally to assess complications with~     respect to these two techniques.~   "
172998|NCT01300702|"~     Investigation of thermal thresholds and sensory mapping to thermal stimuli~   "
172999|NCT01300689|"~     This is a observational study aims to assess anal and genital human papillomavirus (HPV)~     infection status among men who have sex with men (MSM) in China, and their knowledge and~     attitude about HPV vaccine.~   "
173000|NCT01300676|"~     Despite evidence supporting the benefits of hormone replacement therapy (HRT), only 15% of~     postmenopausal women currently use HRT (1). The leading reasons why women refuse or~     discontinue HRT are fear of malignancy, side effects such as vaginal bleeding, weight gain,~     depressed mood, and breast tenderness, and social reasons such as regarding menopause as a~     natural transition, not as a disease that requires treatment. Millions of women expressed~     their concern on the safety of hormone replacement therapy since the data from the Women's~     Health Initiative (WHI) study was released, which reported an increased risk of~     cardiovascular disease, breast cancer, stroke and thromboembolic disease with conjugated~     equine estrogen plus medroxyprogesterone acetate compared with placebo (2). The study has~     also demonstrated that quality of life (3) and cognition (4) were no better in the HRT group~     than the placebo group. In view of these problems, women are increasingly turning to~     alternative therapies in an effort to manage their menopausal symptoms (1).~      Menopause is associated with decreasing sex steroid levels. The effect of menopause on~     circulating androgen levels has been studied by several investigators with variable findings.~     The levels of testosterone and androstenedione appear to show a small but significant~     decrease just before or within the first 2 years after menopause, with a decrease in~     testosterone amounting to approximately 15% (5,6). Unlike the abrupt decrease in estradiol~     levels associated with menopause, circulating testosterone, DHEA, and DHEAS levels decrease~     more gradually, beginning in the years before menopause and continuing thereafter (6,7). As a~     consequence, some women may experience symptoms of androgen decrease in the period before~     cessation of menses. By giving Tualang Honey to these postmenopausal women, it is postulated~     that the symptoms of androgen deficiency or menopausal symptoms should be reduced.~      The investigators have also reported that tualang honey given to ovariectomised rats, an~     animal model for postmenopausal states for two weeks significantly increased the free~     testosterone and progesterone plasma levels, but no significant effect was seen in the~     beta-estradiol level. There were significant increased in the thickness of vaginal epithelium~     and vaginal epithelial-muscular layers. Proliferation of the squamous epithelium with~     vacuolation of some of the squamous cells were noted in the honey treated animals implying~     that there were increased in mucopolysacharide content. Uterine weight, endometrial and~     circular muscle thickness were significantly increased in honey treated animal with cystic~     changes noted over the glands (8).~      To date, there are no clinical studies looking at the effects of Tualang Honey on~     perimenopausal women. In view of the initial evidence that it is a phytoestrogen from animal~     studies and has androgenic properties as well, it should have a beneficial effect to these~     women in terms of improvement in their menopausal symptoms, changes in their endogenous~     hormonal profile and increase in bone mineral density.~   "
173001|NCT01300663|"~     Post-surgery complications in women with vulvar neoplasms (vulvar intraepithelial neoplasia~     and vulvar cancer) are still high and an instrument assessing patients self-reported~     post-vulval surgery symptom experiences is missing. The study aims to develop and validate a~     postoperative instrument to assess symptom experiences in women with vulvar neoplasms. In~     this mixed-method project 20 patients were interviewed, a WOMAN-PRO instrument was developed~     and content validity was tested by 6 experts and 10 patients. The instrument's psychometric~     properties and the prevalence of symptoms will be examined in a cross-sectional study in the~     University Hospitals Munich, Freiburg, Berlin, Düsseldorf, Zurich, Basel, Berne, and the~     Cantonal Hospital St. Gallen (N=150). The goal of this project is that symptom assessment~     becomes a standard component of clinical practice (to promote the early detection and~     treatment of symptoms) and research.~   "
173002|NCT01300650|"~     This is an open-label, non-randomized, pilot-study to evaluate the effect of Interleukin-1~     blockade on exercise capacity in patients with heart failure. Subjects will undergo~     cardiopulmonary exercise testing at baseline and after 2-weeks treatment with anakinra~     (recombinant human Interleukin-1 receptor antagonist).~   "
173003|NCT01300637|"~     Background: Several studies have suggested that clozapine has the greatest propensity of all~     available atypical antipsychotics to induce weight gain and metabolic dysregulation. So it is~     necessary to conduct some interventions to prevent or treat metabolic dysregulation induced~     by clozapine.~      Metformin has been reported to achieve weight loss in several groups of patients~     characterized by insulin resistance. Several studies evaluated the effects of metformin on~     antipsychotics-induced weight gain and study period lasted from 8 to 16 weeks. Long-term~     metformin use had more robust effect on metabolic dysregulation and body weight in~     non-psychiatric field.~      Goals: The study goals are two-fold. The first goal is to estimate the prevalence of~     metabolic dysregulation among clozapine-treated schizophrenic patients in Taiwan. The second~     goal is to assess the reversal effect of metformin on metabolic disturbance among~     clozapine-treated schizophrenic patients in a 24-week double-blind, placebo-control trial.~     The investigators will use metformin 1500 mg/d or placebo in the second phase trial.~      Methods: This study will be divided into two phases. The first phase is to estimate the~     prevalence of metabolic disturbances among clozapine-treated patients. The second will be a~     randomized, double-blind, and placebo-controlled study of adjunctive metformin for non-DM~     clozapine-treated patients.~      The clozapine dosage was maintained unchanged during the study period. The eligible patients~     will be randomly assigned to either metformin or identical placebo pills. Metformin will be~     titrated to 1500 mg/day in 4 weeks. Patients' blood pressure (BP), waist circumference, body~     weight, fasting plasma glucose (FPG), triglyceride (TG), high-density lipoprotein cholesterol~     (HDL), insulin, and leptin will be measured at 2, 4, 8, 16, and 24 weeks after the start of~     metformin.~      In a 3-year period, the investigators estimate to recruit 150 clozapine-treated patients in~     the first phase and 75 fulfill the second phase criteria. The investigators estimate 60~     patients complete the second phase intervention (staying in second phase at least 4 weeks).~      From this study, the investigators would like to know the prevalence of metabolic~     dysregulation among clozapine-treated schizophrenic patients and to know the effect of~     metformin on metabolic profile among non-DM clozapine treated patients.~   "
173004|NCT01300624|"~     The purpose of this study is to evaluate the effect of Verb Network Strengthening Treatment~     (VNeST) on the ability to produce sentences and connected speech in persons with aphasia.~   "
173005|NCT01300611|"~     The purpose of this study is to evaluate the effect of TXA127 on neutrophil and platelet~     counts in adult patients who have undergone a double cord blood transplant. The study will~     also evaluate the effect of TXA127 on chemotherapy-induced mucositis, an inflammation of the~     mucous membranes in the digestive tract (mouth to anus) and immune reconstitution which helps~     patients fight infections. For patients undergoing CBT, both neutrophil and platelet~     normalization and immune reconstitution can be delayed. TXA127 has shown to be well tolerated~     by patients and appears to induce a rapid production of neutrophils and platelets in the~     bloodstream as well as increase the immune system components. It has also been shown to~     reduce the severity of chemotherapy-induced mucositis.~   "
173006|NCT01300598|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     degenerative arthritis.~   "
173007|NCT01300585|"~     The purpose of this study is to test a new method of defining patterns of how breast glands~     are or are not attached to the overlying skin. All patients will have markers placed on both~     breasts and will undergo an MRI. MRI results will be examined to identify the pattern of~     breast gland attachment to the overlying skin. This will help identify patients which may~     benefit from areolar sparing and/or nipple sparing technique and which patients should be~     treated by standard mastectomy.~   "
173008|NCT01300572|"~     This phase I trial studies the side effects and maximum tolerated dose of yttrium Y 90~     anti-cluster of differentiation 45 (CD45) monoclonal antibody BC8 (90Y-BC8) followed by donor~     stem cell transplant in treating patients with acute myeloid leukemia (AML), acute~     lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) that is likely to come back~     or spread. Giving chemotherapy drugs, such as fludarabine phosphate (FLU), and total-body~     irradiation (TBI) before a donor peripheral blood stem cell (PBSC) or bone marrow transplant~     helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system~     from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies, such as 90Y-BC8,~     can find cancer cells and carry cancer-killing substances to them without harming normal~     cells. When the healthy stem cells from a donor are infused into the patient they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells. Giving FLU, 90Y-BC8, and TBI before the transplant together with cyclosporine~     and mycophenolate mofetil after the transplant may stop this from happening.~   "
173009|NCT01300559|"~     The overall objective of the investigators research is to test the clinical efficacy of the~     TissueLink™ (Salient Surgical Technologies, Inc.) coagulation system in minimizing hemoglobin~     loss intraoperatively. This is a prospective, randomized investigation that will be performed~     at Duke University Medical Center (DUMC). The overall goal of this study is to evaluate the~     efficacy of Tissue Link HemoSealing system in minimizing hemoglobin loss preoperatively,~     intraoperatively and postoperatively for patients undergoing multilevel elective spinal~     surgery. Not greater than eighty patients scheduled for elective, multi-level decompression~     and fusion spinal surgery with Dr. William Richardson will be randomized into two groups.~     Unipolar electrocautery will be used for intraoperative coagulation in one group and the~     Tissuelink device plus Unipolar electrocautery in the other. These are frequently performed~     cases with significant blood loss but otherwise low morbidity/mortality that would benefit~     from more effective intraoperative coagulation.~   "
173010|NCT01300546|"~     This study is being conducted to evaluate the hypothesis that use of pharmacological and~     non-pharmacological interventions may allow subjects at high risk for chronic migraine to~     avoid or reverse the transformation of episodic migraine to chronic migraine.~   "
173011|NCT01300533|"~     The goal of this Phase 1 clinical research study is to find the highest safe dose of BIND-014~     that can be given in the treatment of patients with advanced or metastatic cancer.~   "
173012|NCT01300520|"~     The current method of incision localization in many surgical procedures requires a doctor to~     reference a medical image, such as an X-ray, to judge where on the body an incision should be~     made. However, the precise information of the scan is not shown on the patient's skin.~     Surgeons commonly use palpation to locate the point of incision. They may feel for the area~     directly or find landmarks under the skin and estimate the location from there. The following~     factors further complicate palpation: overweight patients, foreign bodies that are difficult~     to feel for under the skin, fractures with little displacement, or locations under dense~     muscles. These difficulties are compounded for new surgeons, since palpation is a skill~     derived through experience.~      In many circumstances the surgeon only needs to know where to insert the tool or place the~     incision - they do not necessarily need to know the depth of the area of interest. If~     palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the~     fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer~     to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and the~     patient to radiation. Many fluoroscopic images may be required in a single procedure.~      By identifying the efficacy of this new medical device, Target Tape, there is the potential~     outcome of making smaller incisions, faster localization, a reduction in fluoroscopy use and~     a reduced chance in surgical error and the associated costs.~      Target Tape is a non invasive device that is in a grid or ruler format that is placed against~     the subject's skin. The grid/ruler pattern will then appear on the medical imaging scan.~     Standard surgical skin ink is then used to place these markings in a defined pattern on the~     skin. This pattern mimics the Target Tape grid or ruler pattern. The medical practitioner can~     correlate these skin markings to the medical scan image to make their incisions in more~     accurate locations.~   "
173013|NCT01300507|"~     The PRESTIGE-registry is a joint effort at 9 European heart centers to collect data regarding~     patients presenting with stent thrombosis in a dedicated database. There will be extensive~     clinical and procedural characterization, furthermore blood platelet function testing,~     intracoronary imaging, DNA-sampling and analysis of thrombus aspiration will be performed.~   "
173014|NCT01300494|"~     An optimal angiographic viewing angle is critical for correct diagnosis and intervention in~     coronary bifurcation lesion percutaneous coronary interventions (PCI). The current study aims~     at validating a dedicated software tool (MEDIS, Leiden, The Netherlands) that will improve~     the selection of the best viewing angle.~   "
173015|NCT01300468|"~     The purpose of this open-label, multi center, Phase I study was to determine the safety~     profile of the oral compound PHA-848125AC administered according to two different schedules~     of administrations to advanced/metastatic solid tumor patients. Objectives of the study were~     to determine the maximum tolerated dose and the dose that can be recommended for Phase II~     investigations.~   "
173052|NCT01299974|"~     The study seeks to implement and test a novel approach to teach pediatric residents about~     patient and family-centered care (PFCC). The approach calls for a supervised meeting between~     a family member of a previously hospitalized child and a resident in the context of a~     pediatric residency rotation.~   "
173017|NCT01300442|"~     Transcutaneous electrical diaphragmatic stimulation (TEDS) has been used to improve~     respiratory muscle strength in patients with respiratory muscles weakness. However, this~     physiotherapeutic resource has not been studied in chronic obstructive pulmonary disease~     (COPD) yet. The objective of this study is to evaluate the respiratory pattern during the~     session of TEDS besides its effect in respiratory muscle strength and in spirometric~     variables as much healthy patients as in COPD patients. Methods: healthy and COPD patients~     are selected and submitted to TEDS treatment. The plethysmographic analysis (LifeShirt System~     - VivoMetric), respiratory muscle strength and spirometry will be made. The hypothesis is~     that the TEDS can helps COPD patients that shows respiratory muscle weakness.~   "
173018|NCT01300429|"~     The purpose of this study is to try to learn more about how small molecule kinase inhibitor~     medications work in treating lung cancer. Crizotinib (PF-02341066) is a drug that has been~     shown to shrink tumors in some patients with lung cancer. While the investigators know how~     this drug works to stop the growth of tumors that depend on change in the gene named ALK~     (also called EML4-ALK), the investigators do not know why the drug stops working. The~     investigators would like to examine the tumor to help us better understand why crizotinib has~     stopped working as well as it once did. The tumor will be examined with multiple tests to~     look for the reason that crizotinib stopped working.~   "
173019|NCT01300416|"~     This study will access the GI complaints on patients reported outcomes and to determine the~     improvement in quality of life in patients.~   "
173020|NCT01300403|"~     This study aimed to evaluate the acute physiological effects of expiration with the glottis~     open in lateral posture (ELTGOL) and Flutter valve in dynamic and static lung volumes in~     patients with bronchiectasis and, secondarily, to study the effect of these techniques in~     sputum production.~   "
173021|NCT01300390|"~     The overall hypothesis is that endothelial function, apolipoprotein levels and adiponectin~     levels are accurate predictors of underlying cardiovascular disease in patients with~     end-stage liver disease, in whom standard tools for the diagnosis of and screening for~     cardiovascular disease are of limited utility.~   "
173022|NCT01300377|"~     The goal of the proposed study is to investigate the relationship between two standard~     treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain,~     and; 2) narcotic use following pacemaker or defibrillator insertion in subjects who undergo~     arrhythmia surgery at Baylor Heart and Vascular Institute while adjusting for pertinent~     clinical and/or demographic factors. No control group is necessary.~   "
173023|NCT01300364|"~     Main objective: To assess the efficacy of two antidepressants of different pharmacological~     families: citalopram (Selective serotonin reuptake inhibitors, SSRI) and reboxetine~     (Norepinephrine Reuptake inhibitor, NRI) as adjunct treatments to risperidone and olanzapine~     for the treatment of negative symptoms of schizophrenia.~      Secondary objectives: To assess the efficacy of citalopram and reboxetine as adjunct~     treatments to risperidone and olanzapine for the treatment of cognitive symptoms of~     schizophrenia. To compare the efficacy of reboxetine and citalopram as adjunct treatments for~     the treatment of negative and cognitive symptoms of schizophrenia.~      Method: Multicentric, randomized double-blind clinical trial compared to placebo with a six~     months follow-up. A total of 249 patients with a diagnosis of schizophrenia (DSM-IV criteria)~     and significant negative symptoms, will be recruited in the 9 participating centres.~     Variables: sociodemographic and clinical variables (PANSS, SANS, CGI global, GAF,LSP,~     Hamilton scale, BACS)~   "
173024|NCT01300351|"~     The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with~     the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive~     advanced breast cancer who have failed a prior endocrine treatment.~   "
173025|NCT01300338|"~     Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a~     primary care practice?~   "
173026|NCT01300325|"~     Acute bronchiolitis is the main cause for respiratory illness that requires hospitalization~     in children younger than 2 years. In the United States it has been shown that the burden of~     the disease is considerable, having an annual cost of more than $ 500 million and being~     responsible for the 17% of all infant hospitalizations . Aim of the present study was to~     verify the effects of nebulized 3% saline solution in comparison to normal saline in~     addiction to epinephrine in a large population of RSV positive cases of bronchiolitis; all~     patients presented a disease as much as severe to require hospitalization.The main study~     endpoints were the length of stay in hospital and the clinical response.~   "
173027|NCT01300312|"~     The purpose of this study is to investigate the effects of a fixed dose combination of~     diclofenac and eperisone hydrochloride compared with plain eperisone hydrochloride in~     patients with low back pain.~   "
173028|NCT01300299|"~     This trial will test the feasibility of adjuvant chemotherapy after stereotactic body~     radiation therapy for early stage non-small cell lung cancer (NSCLC).~   "
173029|NCT01300286|"~     The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL~     Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving~     hemostasis thereby reducing overall blood product transfusion after separation from~     cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size~     this is a pilot study and in effect will determine the fibrinogen level response to~     fibrinogen concentrate administered during aortic reconstructive surgery. It will be~     underpowered to detect reduction in bleeding but comparison to historical controls will be~     included as a secondary outcome.~   "
173030|NCT01300273|"~     The investigators hypothesize that, LPD supplemented with ketoanalogs will reduce urine~     podocyte loss and lower the angiotensinogen level in the urine.~   "
173031|NCT01300260|"~     The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in~     response to glucose intake.~   "
173051|NCT01299987|"~     This prospective, multicentric single arm phase II study is based on the protocol of the~     international TARGIT-A study. The purpose is to investigate the efficacy of a single~     intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, cT1, cN0,~     cM0, invasive-ductal) which is followed by WBRT only when risk factors are present. In~     presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic~     treatment according to international guidelines.~   "
173061|NCT01299857|"~     The purpose of this study is to study the midterm clinical evaluation, biological parameters~     and immune reconstitution after Rituximab treatment for Pemphigus.~   "
173032|NCT01300247|"~     This open-label, 2-arm, nonrandomized, multicenter, Phase Ib study will investigate the~     safety and efficacy of obinutuzumab (RO5072759; GA101) administered in combination with~     chemotherapy (bendamustine or fludarabine + cyclophosphamide [FC] regimens) in participants~     with previously untreated cluster of differentiation 20 (CD20)-positive B-CLL. Participants~     will be enrolled to receive a maximum of 6 cycles of obinutuzumab (1000 milligrams [mg]~     intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus~     bendamustine (90 milligrams per meter square [mg/m^2] IV, on Days 2 and 3 of Cycle 1 and Days~     1 and 2 of Cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of obinutuzumab (1000 mg~     IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus FC (fludarabine~     25 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2 - 6;~     cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2~     - 6) on 28 day cycles.~   "
173033|NCT01300234|"~     This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate~     the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This~     study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating~     Chinese subjects with CHB (hepatitis B e antigen [HBeAg] positive subjects and HBeAg negative~     subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF~     300 mg administered once daily.~   "
173034|NCT01300221|"~     The propose of this study is to generate normative data of the tree-dimensional~     echocardiographic(3-DE) measurements for cardiac structure and function in a large cohort of~     normal infants, children,and adolescents. The investigators also sought to investigate the~     utility of 3-DE in evaluating infants, children and adolescents with congenital and acquired~     heart diseases.~   "
173035|NCT01300208|"~     This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety,~     tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.~   "
173036|NCT01300195|"~     Prospective cohort study of factors predisposing to persistent post surgical pain after~     video-assisted thoracic surgery~   "
173037|NCT01300182|"~     To investigate the effect of early WBVT on neuromuscular control after ACLR.~   "
173038|NCT01300169|"~     This is a randomized controlled trial comparing the use of new clinical intervention (the~     Collaborative Assessment and Management of Suicidality--CAMS) versus enhanced care as usual~     for suicidal Soldiers who are seen at outpatient mental health clinics at Ft. Stewart GA.~   "
173039|NCT01300156|"~     The purpose of this study is to evaluate the efficacy and safety of combination chemotherapy~     with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (ESHAOx) for~     patients with refractory or relapsed Hodgkin's lymphoma (HL).~   "
173040|NCT01300143|"~     Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose~     total tumor mass can technically be irradiated, non-resectable, and not a candidate for~     percutaneous therapy with recommended treatment via hyperselective transarterial~     chemoembolisation (TACE).~   "
173041|NCT01300130|"~     The investigators examined the effect of different levels of docosahexaenoic aicd (a long~     chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and~     erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm~     infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid into~     their corresponding long chain polyunsaturated fatty acids was studied.~      Preterm infants were randomized in a double-blind fashion to one of three formulas containing~     different amounts of docosahexaenoic acid during the first two weeks of postnatal life. A~     control group received human milk. Blood samples were collected at study entry and 14 and 28~     days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were applied~     orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56 weeks~     visually evoked potentials were recorded.~   "
173042|NCT01300117|"~     The purpose of this study is to determine whether extracorporeal circulation during cardiac~     surgery has an influence on ADAMTS13-Activity.~   "
173043|NCT01300104|"~     PURPOSE:~      To evaluate the feasibility of a future Nordic intervention trial, including vigorous~     activity and a high intake of whole grain rye, among prostate cancer patients on active~     surveillance.~      Additionally, to investigate effects of the lifestyle intervention according to cancer~     progression, the metabolic profile, inflammation and quality of life among prostate cancer~     patients on active surveillance.~   "
173044|NCT01300091|"~     Consumption of medical care and outcome of shoulder pain and disability in primary care.~   "
173045|NCT01300078|"~     This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy,~     postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses~     of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United~     States.~   "
173046|NCT01300052|"~     The purpose of this study is to determine whether AN2728 topical ointment is a safe and~     effective treatment for mild-to-moderate plaque-type psoriasis.~   "
173047|NCT01300039|"~     The investigators are finding out if giving antibiotics for Helicobacter pylori will~     eliminate colonization of the colon by Oxalobacter formigenes.~   "
173048|NCT01300026|"~     This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with~     relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose~     exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid~     malignancies and uses a practical continuous reassessment model [CRM] to guide dose~     escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with~     CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical~     activity of AMG 319 in this patient population.~   "
173049|NCT01300013|"~     The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV)~     omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular~     systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized,~     double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of~     ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to~     omecamtiv mecarbil or placebo.~   "
173050|NCT01300000|"~     The primary objective of the study is to compare the growth of infants fed standard infant~     formula with infants fed a reduced calorie and protein formula.~   "
173053|NCT01299961|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing~     pain and swelling) associated with significant health problems. It is a difficult disease to~     manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints~     that can cause joint damage, deformity, and progressive disability and impairment. It is~     estimated that 1% of the world's population suffers from this disease.~      The purpose of this research study is to determine if a change in inflammation seen on the~     ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to~     treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.~   "
173054|NCT01299948|"~     There has been reports that low dose prednisolone stabilizes CD4-counts in HIV infected~     individuals. However, until now, there are no prospective randomized studies on the use of~     corticosteroids in latent HIV disease. Furthermore, low dose prednisolone (5 mg/d) is not~     sufficient tested for the risks and benefit for HIV patients especially for those living in~     poor settings with a higher risk of infections. This study will assess the benefit and the~     safety profile for low dose prednisolone therapy for patients in a region with limited~     resources and high prevalence of infections.~   "
173055|NCT01299935|"~     This randomized controlled clinical trial tests the hypothesis that a selected stress~     reduction approach, the Transcendental Meditation program will reduce all-cause mortality,~     myocardial infarction and stroke in African American patients with coronary heart disease.~     Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure~     and psychosocial stress.~   "
173056|NCT01299922|"~     The treatment of lupus nephritis with cyclophosphamide and steroids changed the prognosis of~     lupus nephritis in the early '80s. In recent years, alternative regimens have appeared in~     both the induction and maintenance with similar results at least to those offered by the~     classic pattern and possibly with fewer side effects, especially for long term. The~     association of prednison and mycophenolate has created large expectations to that effect, and~     is part of first-line therapeutic arsenal of lupus nephritis type III, IV and V.~      Despite the significant advances that have led to these treatments, the likelihood of~     complete remission after six months remains, according to the series of 8-13% and partial~     remission do not exceed 60% in papers published. In the last year, two articles have been~     published supporting the use of triple therapy (prednisone, mycophenolate, cyclosporine) in~     poor prognosis of lupus nephritis with hopefully better results than those obtained~     previously. In this study we try to compare the effectiveness of triple therapy, the therapy~     is now considered standard (prednisone, mycophenolate) in patients with lupus nephritis type~     III-IV-V~   "
173057|NCT01299909|"~     The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The~     study design includes two randomized arms to compare matched intensive interventions and a~     third non-randomized option for participants who prefer not to enter an intensive~     intervention. It is expected that roughly 50% (120) will choose to be in the randomized~     intensive interventions and 50% (120) will choose to be in the non-intensive intervention.~     Participants who choose to be in an intensive intervention will be randomized to either~     Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers~     (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes over~     a 6-week period and 2 weeks of nicotine patches. MTS provides and training in mindfulness~     whereas ITS provides training in quit smoking strategies and access to the Freedom From~     Smoking Online Premium Program. Participants who choose to be in a non-intensive intervention~     (estimated from prior recruitment data at n=120) will receive a phone-based intervention~     through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine patches.~   "
173058|NCT01299896|"~     The purpose of this research study is to examine the effectiveness of an intervention~     designed to reduce smoking in low income veterans within a regional United States Veterans~     Administration(VA) health care system. A proactive, personalized, coordinated system of care~     Connect to Quit (CTQ) is rooted in the Chronic Care Model. CTQ treats smoking as a chronic~     condition, like hypertension or diabetes, that requires long term treatment with appropriate~     combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context~     of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.~   "
173059|NCT01299883|"~     The investigators will evaluate the effects of an integrated risk counseling program on~     behavioral and psychological outcomes in African American men and women in a randomized trial~     that is implemented and evaluated collaboratively through the West Philadelphia Consortium to~     Address Disparities. The specific aims of this research are as follows:~        1. To evaluate the effects of integrated versus disease specific counseling on risk~          exposure behaviors. The investigators predict that compared to individuals who receive~          disease specific counseling, those who receive integrated counseling will report greater~          intake of fruits and vegetables and increased rates of physical activity.~        2. To evaluate effects of integrated versus disease specific counseling on psychological~          outcomes. The investigators predict that compared to individuals who receive disease~          specific counseling, those who receive integrated counseling will report greater risk~          comprehension related to cancer and cardiovascular disease and will be more motivated to~          make behavioral changes.~        3. To identify the mechanisms through which integrated risk counseling leads to behavioral~          change. The investigators predict that changes in risk exposure behaviors (e.g., diet~          and physical activity) will be mediated by increased risk comprehension and~          self-efficacy for diet and physical activity.~   "
173060|NCT01299870|"~     Epilepsy is a disorder in the brain. The brain is full of nerve cells. Nerve cells have~     normal electrical activity to control the many functions of the body. Sometimes nerve cells~     do not function normally due to many different reasons such as disease, an injury or because~     the brain didn't develop normally at birth. When nerve cells do not function normally the~     electrical activity that controls things like muscles and body movement can get mixed up and~     cause seizures. When a seizure occurs, sometimes a person loses control of body movement,~     and/or bodily functions. When a seizure occurs, a person may become unconscious, and/or~     senses may be affected. Seizures can occur at any time, without warning, and can lead to many~     health problems.~      Catamenial epilepsy is specific form of epilepsy in women. It is closely related to the~     menstrual cycle. In this form of epilepsy seizures increase around the menstrual period.~      By doing this study, researchers hope to learn whether Keishibukuryogan add-on therapy with~     antiepileptic drugs is safe for women with epilepsy.~   "
173062|NCT01299844|"~     The objectives of this study are:~        -  To develop a comprehensive culturally tailored model of diabetes management that~          integrates the work of community-based peer counselors and clinical specialists into a~          multi-disciplinary health care team serving the Latino community.~        -  To implement an intervention that provides education and support to Latino adults~          diagnosed with Type 2 diabetes in both clinical and home settings.~        -  To evaluate this intervention for its impact on program adherence, and improved outcomes~          sustained over time as reflected by metabolic, clinical, cognitive and behavioral~          measures.~   "
173063|NCT01299831|"~     The purpose of this study is to investigate signaling pathways in fat and muscle, as well as~     turnover of protein, sugar and fat after stimulation with growth hormone and during fasting~     in lean and obese subjects. This will help clarify differences in the human metabolism~     between lean and obese subject and provide us with a better understanding of the molecular~     mechanisms regulating the basic metabolism during prolonged fasting.~   "
173064|NCT01299818|"~     -  Pain is one of the most common concerns for which patients seek medical attention.~        -  Pain is usually understood as symptom that reflects peripheral organic damage. Many~          patients experience pain, often chronically, independently of any underlying cause such~          as chronic regional pain syndromes (irritable bowel syndrome, temporo-mandibular pain~          syndrome, chronic headache or chronic low back pain)or diffuse like in fibromyalgia. In~          all those functional syndromes, accumulated evidence supports involvement of central~          pain processing systems, hypothalamic pituitary adrenal axes and autonomic nervous~          system, and are now referred as central pain conditions.~        -  Other patients suffers from chronic pain caused by damage or inflammation in peripheral~          tissues, but also experienced more diffuse pain, not directly explained by peripheral~          damage, that further aggravates pain and function. This is illustrated by the high~          prevalence of fibromyalgia observed in patients with rheumatoid arthritis,~          osteoarthritis or ankylosing spondylitis for example.~      These pain conditions are now understood as combinations of peripheral, neuropathic and~     central pain.~      The investigators aimed to focus in this study in patients that are candidates to spinal~     surgery and suffer from low back pain and/or radiculopathy. Pain in these patients may arise~     from damage to nerves - neuropathic pain- , to musculoskeletal structures - peripheral pain-,~     and may also reflects alteration in central pain processes.~      In these patients, spine surgery is usually performed to improve quality of life, decrease~     pain and avoid neurological deficits. Evaluation of surgical outcome includes objective~     measures such as neurological findings and radiographic evaluation, and subjective measures~     including patient self-assessments for pain and quality of life and psychological changes.~      The aim of this study is to evaluate patients who undergo spinal surgery for presence of~     central pain and central sensitization symptoms and evaluate their influence on these~     surgical outcomes~   "
173065|NCT01299805|"~     The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the~     body), the pharmacokinetics (the body's handling of the drug), and the safety and~     tolerability of vortioxetine, once daily (QD) in healthy men.~   "
173066|NCT01299792|"~     Video-urodynamic investigations are regarded as the current standard diagnostics for~     neurogenic bladder dysfunction in patients with spinal cord injury. This examination is~     exact, but time consuming, costly and associated with the risk of urinary tract infection.~      In patients with lower urinary tract symptoms due to benign prostate hyperplasia, sonographic~     measurement of bladder wall thickness has been demonstrated to be able to replace urodynamic~     testing for the diagnosis of infravesical obstruction.~      Hypothesis: measurement of bladder wall thickness in patients with neurogenic bladder~     dysfunction due to spinal cord injury is closely related to the known risk factors for upper~     urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group~     of patients and can therefore replace urodynamic examination in selected cases.~   "
173067|NCT01299779|"~     Objective: To compare the incidence of peri-colonoscopy hyponatremia associated with PEG 3350~     + sports drink (PEG-SD) versus PEG 3350-electrolyte solution + sodium sulfate + sodium~     ascorbate and ascorbic acid (PEG-ELS).~      Hypothesis: As compared to PEG-SD, hyponatremia occurs significantly less often with PEG-ELS.~   "
173068|NCT01299766|"~     The goal of this study is to determine whether increasing participation in cognitive,~     physical, and/or social activities prevents cognitive decline in older African Americans~     (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for~     Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent~     cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this~     hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and~     older) will be randomized to Behavior Activation (BA) (a behavioral intervention that~     increases participation in daily activities) or Supportive Therapy (ST) (a person-centered~     psychotherapy that involves active listening and offering support focusing on participants'~     problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in~     cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and~     better quality of life than ST-treated subjects at 24 months.~   "
173069|NCT01299753|"~     Severe burn is associated with a wide array of stress, metabolic, and physiologic processes~     in an attempt to restore homeostasis. The catecholamine induced stress response following~     severe burns is particularly exaggerated and manifests detrimentally as inflammation, insulin~     resistance, hypermetabolism, and associated profound protein catabolism. The investigators~     hypothesize that catecholamine blockade will lead to restored IR signaling and result in~     improved post-burn morbidity. The investigators will further determine the molecular~     mechanisms mediating these effects.~   "
173079|NCT01299623|"~     We will develop and evaluate a community-based approach for disseminating comparative~     effective reviews (CERs) about breast cancer prevention to African American women. The~     specific aims of our research, as shown below, will target this population because of~     persistent disparities in breast cancer morbidity and mortality among this population. Our~     primary aims are:~        1. To evaluate uptake of a community-based strategy for disseminating CERs about breast~          cancer prevention to African American women based on sociodemographic characteristics,~          beliefs about medical research, and medical history. We predict that participation in a~          community forum will be higher among women with greater socioeconomic resources, those~          who have a family history of breast cancer, and women who have more positive beliefs~          about research.~        2. To evaluate the impact of evidential versus non-evidential content about breast cancer~          prevention on psychological and behavioral outcomes that include: knowledge of breast~          cancer risk factors and prevention strategies, communication with individuals in their~          social and medical network, and distrust of medical research. We predict that women who~          receive evidential content that is specific for African American women will report~          greater knowledge about breast cancer risk factors and prevention strategies, will be~          more likely to discuss breast cancer prevention strategies with individuals in their~          social and medical network, and will report greater reductions in distrust of medical~          research compared to those who receive non-evidential content.~   "
173070|NCT01299740|"~     Dialectical Behavioral Therapy (DBT) based skill groups for emotionally dysregulated children~     and their parents~      The investigators propose implementing a Dialectical Behavioral Therapy (DBT) skills group~     format for emotionally dysregulated children between the ages of 8 and 12 and their parents.~      Introduction Treatments available for children with emotional dysregulation and behavioral~     problems were shown to be only partially effective.~      DBT combines the western principles of changing behavior with the eastern principles of~     acceptance and mindfulness.~      Efficacy of DBT has been shown across a number of behavioral problems in adults and has been~     successfully adapted for adolescents. The next logical step is modification for younger~     children.~      The investigators chose DBT because of the observed similarities between adults and~     adolescents diagnosed with borderline personality disorder and the children who are referred~     to the investigators clinic with emotional dysregulation.~      Aims: To assess the ability to regulate emotions and problem behaviors before and after the~     proposed intervention~      Method:~      Population: Between 6-10 children between the ages 8-12 will be recruited from The child and~     adolescent psychiatric outpatient clinic at Soroka University Medical Center.~      Inclusion criteria Children suffering from emotional dysregulation All children and at least~     one parent speak Hebrew Exclusion criteria~        1. Schizophrenia~        2. Bipolar disorder~        3. Psychosis i.e an overt thought disorder~        4. Mental retardation~        5. Severe learning disorders~        6. Pervasive developmental disorders.~        7. Children who have suffered brain injury.~      Comparison group: Between 6 and 10 children matched for sex, parents age and education,~     socioeconomic status that fulfill the same clinical criteria for inclusion in the study as~     the study group. The comparison group will receive treatment as usual.~      Procedure The children will participate in a group skills group over 20 sessions, each~     session an hour and a half. The parents will participate in a group skills group over 15~     sessions, each session an hour and a half. Each group will be lead by two therapists. All the~     children will be evaluated by board certified child and adolescent psychiatrist and will be~     diagnosed according to the DSM IV-TR. The parents' the child and a teacher who is familiar~     with the child will fill in questionnaires before the beginning of the group, at the end of~     the group process and 6 months after the group ends.~      The treatment protocol will be based on Linehan's Skills training manual for treating~     borderline personality disorder and on modifications made by Miller for adolescents. The~     groups will be conducted according to a treatment manual which will be written accordingly~     and modified in order to apply the skills to a younger population. Ancillary treatment ( e.g.~     pharmacotherapy) will be provided on an as needed basis.~      The control group the data will be collected at similar intervals to those in the study~     group.~      Written informed consent will be obtained from the child and a legal guardian.~        -  ‬~        -  ‬~   "
173071|NCT01299727|"~     Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease~     (LSD) caused by loss in activity of 1 of 9 enzymes necessary for degradation of the~     glycosaminoglycan (GAG) heparan sulfate (HS) in lysosomes. MPS IIIA results from deficiency~     of the enzyme heparan N-sulfatase (sulfamidase). In the absence of this enzyme, intermediates~     of the HS degradation process accumulate in the lysosomes of neurons and glial cells, with~     lesser accumulation outside the brain. MPS IIIA symptoms arise on average at 7 months of age,~     with the average age of diagnosis at 4.5 years for the majority of patients. Patients present~     a wide spectrum and severity of clinical symptoms. The central nervous system (CNS) is the~     most severely affected organ system in patients with MPS IIIA, evidenced by deficits in~     language development, motor skills, and intellectual development. In addition, there are~     abnormal behaviors including but not limited to aggression and excess motor~     activity/hyperactivity that contribute to disturbances in sleep.Overall, individuals with MPS~     IIIA have a marked developmental delay and significantly reduced lifespan to 15 years of age~     on average.~      The purpose of this study is to collect long term safety and tolerability data in patients~     with MPS IIIA who previously received rhHNS in study HGT-SAN-055 (NCT01155778).~   "
173072|NCT01299714|"~     Researchers at The Ohio State University and the University of Michigan are working together~     to understand cancer of the cervix. One of the areas they are studying is how stress you may~     experience in your life effects the way you respond to GARDASIL®. GARDASIL® is a vaccine~     approved by the Food and Drug Administration (FDA) to prevent some types of Human~     Papillomavirus (HPV) infection which can cause cancer of the cervix. Participants are being~     recruited from the Appalachian region of Ohio.~   "
173073|NCT01299701|"~     This study is designed to characterize the absorption, distribution, metabolism and excretion~     (ADME) of ASA404 following a single intravenous administration of 3000 mg (approximately 1800~     mg/m2) ASA404 containing 60 µCi of 14C over a period of 20 minutes in patients with advanced~     solid tumors. Metabolic pathways, route (s) of elimination, distribution characteristics in~     plasma and blood, and exposure characterization in plasma and blood, and exposure~     characterization of the parent drug and metabolites will be obtained from the study.~   "
173074|NCT01299688|"~     The investigators propose to survey the frequency of HER2 (+) CTC in order to lay groundwork~     for future clinical trials incorporating Her-2 targeted agents in gastric cancer.~   "
173075|NCT01299675|"~     The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of~     the SureScan pacing system when used in an MRI environment according to product labeling.~     This study is required by the Food and Drug Administration (FDA) as a condition of product~     approval.~   "
173076|NCT01299662|"~     Vaccines induce protective immunity against numerous infectious diseases. However, current~     vaccines have limited efficacy against challenging infections like tuberculosis, malaria, and~     HIV. Protein vaccines are safe but, typically they induce weak T cell immunity when~     administered alone. Therefore, special attention is being given to adjuvants, which are~     enhancers of immunity, that cab mature antigen presenting immunostimulatory dendritic cells.~     Our goal is to study in humans the mechanism whereby a synthetic adjuvant, poly ICLC, which~     acts on defined pattern recognition receptors, enhances T an B cell immunity. In preclinical~     studies, our lab has found in mice that poly IC and its analog poly ICLC are superior~     adjuvants for T cell mediated immunity relative to other agonists for PRR. Poly ICLC has been~     extensively studied in humans with a favorable safety profile. In a recently completed Phase~     I study, poly ICLC was found to be safe and well tolerated when administered as a single dose~     of 1.6 mg subcutaneously and intranasally to healthy volunteers. In additional, preliminary~     data shows marked upregulation of gene expression in whole PBMSc following s.c. injection of~     poly ICLC as well as activation of various blood cell type, including dendritic cells and~     monocytes. In this study the investigators propose to extend the evaluation of innate immune~     responses following s.d. injection of poly ICLC to healthy volunteers. The investigators~     propose to characterize poly ICLC effects on specific blood cell types, focusing on three~     different subsets of DC's, by analyzing gene transcriptional changes at baseline and at one~     day following its administration. In order to study the early local effects of poly ICLC,~     which are important for the recruitment and activation of antigen presenting cells, the~     investigators also propose to perform skin biopsies at a skin site contralateral to the~     injection site and at the injection site after poly ICLC injections.~   "
173077|NCT01299649|"~     Retrospective analysis to observe changes in short term mortality~   "
173078|NCT01299636|"~     The purpose of the study is to determine the maximum tolerated dose and the recommended dose~     and to evaluate the safety and tolerability of PM060184.~   "
173080|NCT01299610|"~     This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of~     GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. Subjects~     will be assigned to take 3 out of the 4 possible treatments for 21 ±2 days: GW870086X 0.2%~     cream, GW870086X 2% cream, FP 0.05% cream (as a positive control) and placebo cream. All~     subjects will be randomised to receive placebo cream. Three index lesions located on the arms~     and/or legs (one on each) will be identified per subject and each treatment will be applied~     to the same lesion.~   "
173289|NCT01296841|"~     The investigators hypothesize that outpatient clinical care of Inflammatory Bowel Disease~     patients may be provided using a new computerized system over standard network - called~     Collaborative Imaging - with similar patient experience compared to a conventional clinic~     visit.~   "
173081|NCT01299597|"~     The present study will investigate in humans the enzyme inhibition effects of SB-649868 on~     CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single~     doses: alone, and on two different occasions after repeat doses of SB-649868, at the same~     time as SB-649868 and 2h before SB-649868.~   "
173082|NCT01299584|"~     This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil~     during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not~     described as precautions or warnings and to identify prognostic factors that have an effect~     on the AEs and to assess effectiveness of remifentanil in real clinical practices after~     marketing.~      The subjects are patients prescribed for remifentanil by the investigators at the sites based~     on prescription information in normal clinical practices.~   "
173083|NCT01299571|"~     An open label, multi-centre, non-interventional post-marketing surveillance to monitor the~     safety and/or efficacy of AVODART administered in Korean BPH patients according to the~     prescribing information~   "
173084|NCT01299558|"~     This study is being done to look at the absolute bioavailability of fluticasone furoate and~     GW642444 inhalation powder when administered in healthy subjects. Bioavailability is~     determined by measuring the amount of the dose of inhaled medication that reaches the~     circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared~     to the medication administered intravenously (where bioavailability is 100%).~   "
173085|NCT01299545|"~     Study Design & Objectives:~      Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with~     a clinical follow-up between 12 and 14 weeks.~      To determine the performances of the RA-INF-Dx blood test intended to aid in the~     identification of patients with rheumatoid arthritis who are unlikely to show an initial~     response to infliximab and methotrexate combination therapy evaluated according to EULAR~     response criteria.~      Ancillary study objective:~      To constitute a biocollection of samples associated with all clinical and biological data~     collected at inclusion and at the evaluation visit.~   "
173086|NCT01299532|"~     This is an open, multi-center, non comparative study to evaluate the safety and efficacy of~     Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a~     maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection~     (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed~     for 24 months after last treatment.~   "
173087|NCT01299519|"~     This study will evaluate the potential beneficial cardiometabolic effect of moderate (5%)~     weight loss and progressive (5%, 10%, and 15%) weight loss in obese adults without diabetes.~     Participants will be randomly assigned to one of 2 groups. Group 1: supervised weight loss~     group (low-calorie diet). Group 2: supervised weight maintenance group (normal diet). Of~     those assigned to group 1, half of the participants will lose 5% of their body weight and the~     other half will lose 5%, 10%, and 15% of their weight over time under the guidance of a~     dietitian. Research testing will be repeated at each time point (5%, 10%, and 15% weight~     loss). In group 2, research testing will be repeated after six months.~   "
173088|NCT01299506|"~     This is an observational, non-randomized, open label, multicenter, phase IV study, which aims~     to reflect a real-life practice routinely used for the management of advanced soft tissue~     sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to receive~     these drugs in the Netherlands. This study pretends to reflect the use and schedule of~     chemotherapy regimen with trabectedin and/or other conventional care regimens such as other~     palliative chemotherapy/biological therapies or best supportive care (BSC) in the management~     of advanced soft tissue sarcoma patients in the clinic based at the discretion of the~     Investigator.~      There are no pre-defined limits of administered cycles of trabectedin treatments or chemo-~     and/or biological therapy; thus, those treatments may continue as long as deemed necessary by~     the Investigator~   "
173089|NCT01299493|"~     Colorectal cancer is the second leading cause of cancer death and one of the most commonly~     diagnosed malignancies. Screening is effective at reducing incidence and mortality from~     colorectal cancer. This study will evaluate the effectiveness of implementing systems-changes~     in community health centers that facilitate screening.~   "
173090|NCT01299480|"~     This study is to look at a new vaccine that might prevent meningococcal disease, and to look~     at the safety of the new vaccine as well as how well it is tolerated. This study will also~     look at this vaccine being given 2 or 3 times. This study will be done in healthy~     adolescents.~   "
173091|NCT01299467|"~     The purpose of this study is to find out how long the effect of PF-03526299 last after it is~     inhaled by assessing the lung function of mild asthma patients after they have been exposed~     to allergen~   "
173092|NCT01299454|"~     The purpose of this study is to evaluate how much of the investigational product gets into~     the blood stream and how long the body takes to get rid of it when given to subjects with a~     range of liver impairment compared to subjects with normal liver function.~   "
173093|NCT01299441|"~     The purpose of this study is to determine whether the endotracheal cardiac output monitor~     (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory~     changes.~   "
173094|NCT01299428|"~     The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry~     (NIRS) at the hypernatremic dehydration in newborns.~   "
173095|NCT01299415|"~     This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an~     inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The~     purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and~     ASA404. The purpose of the Extension Phase is to provide continued treatment for those~     patients that have not progressed during the Core Phase and to collect safety data on ASA404~     when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin~     chemotherapy regimen.~   "
173096|NCT01299402|"~     The purpose of the study was designed to evaluate the efficacy and safety of Soulera herbal~     mix in powder form and its effects on anxiety and the biomarkers for chronic stress.~   "
173097|NCT01299389|"~     The purpose of this study is to evaluate the efficacy and safety of paliperidone palmitate as~     compared with placebo in the treatment of participants with schizophrenia (psychiatric~     disorder with symptoms of emotional instability, detachment from reality, often with~     delusions [a false belief held in the face of strong differing evidence, especially as a~     symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into~     the self).~   "
173098|NCT01299376|"~     This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan~     potassium 50 mg [L50] (+) hydrochlorothiazide 12.5 mg [H12.5] (+) amlodipine besylate 5mg~     [A5]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in~     Japanese participants. In the second part, the safety and tolerability of long-term use of~     open-label MK-0954E in participants with hypertension will be evaluated. The primary~     hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic blood~     pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in Japanese~     participants with essential hypertension who are not adequately controlled following a 8-week~     treatment with filter period study drug of MK-954H.~   "
173099|NCT01299363|"~     This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and~     without vaginal dilator use following surgery for pelvic organ prolapse with traditional~     posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through~     week 8 after posterior repair will reduce the rate of de novo dyspareunia.~   "
173100|NCT01299350|"~     Our objective is to compare a policy of hospital discharge guided by NT-proBNP levels versus~     discharge guided by conventional clinical criteria, in patients admitted with acute heart~     failure. The hypothesis is that the Nt-proBNP guided discharge will shorten hospital stay~     without worsening the outcome~   "
173101|NCT01299337|"~     The purpose of this study is:~        -  To evaluate liothyronine (Cytomel) as an accelerating agent (i.e. faster rate to~          clinical remission) to electroconvulsive therapy.~        -  To evaluate whether thyroid supplement acceleration can reduce the neurocognitive side~          effect of ECT treatment.~        -  To evaluate whether thyroid status at the time of remission is associated with~          subsequent relapse rate.~        -  To evaluate genetic polymorphisms in enzymes responsible for thyroid metabolism and the~          serotonin transporter promoter gene in depression (5-HTTLRP).~   "
173102|NCT01299324|"~     The primary objective of this feasibility study is to provide clinical data to demonstrate~     the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC)~     produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients~     diagnosed with congestive heart failure (CHF).~   "
173103|NCT01299311|"~     The effect of Non-Exercise Activity Thermogenesis (NEAT) or inactivity on insulin sensitivity~     and lipid metabolism is unclear. Research recently published shows that activities associated~     with everyday activities, summarized as NEAT, such as walking and standing, have a much~     greater role in energy expenditure than exercise. Therefore, the objective of the present~     study is to evaluate the effect of 4 days of inactivity (mainly sitting), 4 days of everyday~     activities (sitting, walking and standing), and 4 days of inactivity and exercise (sitting~     and biking) on glucose metabolism and insulin sensitivity using an oral glucose tolerance~     test, and on lipid metabolism in sedentary, overweight people. The investigators hypothesize~     that:~        1. 4 days of everyday activities (NEAT) will cause an increased glucose tolerance and~          increased insulin sensitivity compared to 4 days of inactivity in sedentary, overweight~          people.~        2. 4 days of exercise will improve glucose tolerance and insulin sensitivity more than 4~          days of NEAT with equal energy expenditure, in sedentary, overweight people.~        3. Fasting triglyceride will have the same course as glucose, mentioned in 1. and 2.~   "
173104|NCT01299298|"~     This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50,~     mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers. Eligible subjects will~     receive a single study injection of either mipomersen or placebo. Subjects will be enrolled~     into 1 of 3 treatment cohorts (Cohorts A, B, and C) in a dose-escalation design.~     Dose-escalation will proceed only if there is an acceptable safety profile from the previous~     dosing level.~   "
173105|NCT01299285|"~     This is a single dose study of radiolabeled [14C]-LY3009104 in healthy male volunteers to~     study the absorption, distribution, metabolism, and elimination of LY3009104. This study~     requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes~     only and is not intended to treat any medical condition.~   "
173106|NCT01299272|"~     The primary objective of this study was to assess the maintenance of efficacy of LY2216684~     compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors~     (SSRIs) as measured by the time-to-symptom reemergence among participants with major~     depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the~     stabilization period.~      This trial consists of two distinct periods: an open-label treatment period, which consists~     of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if~     participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a~     randomized, double-blind, placebo-controlled period for 24 weeks.~   "
173107|NCT01299259|"~     The investigators hypothesize that text message reminders to girls diagnosed with pelvic~     inflammatory disease (PID) in the emergency department (ED) will improve follow-up to their~     primary care provider (PCP) after being discharged from the ED.~   "
173108|NCT01299246|"~     Objectives:~      Preventing diabetic foot problems (DFP) and associated consequences, such as amputation, is a~     critical in rural regions. The objective is to present on the association of non-invasive DFP~     assessment tools and physiological indicators for the early detection of DFP among rural~     cases of diabetes in Taiwan.~   "
173109|NCT01299233|"~     To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real~     Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg~     Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle~     scan-measurements.~        -  Trial with medical device~   "
173110|NCT01299220|"~     This study will look at if a low-dose regimen of acitretin is helpful in treating a skin rash~     caused by the chemotherapy drug, erlotinib.~   "
173143|NCT01298791|"~     Patient satisfaction is affected by physician communication styles and communication at the~     bedside. The investigators are conducting a randomized controlled trial involving both~     providers and families to determine if providers sitting down while talking with families,~     will improve one aspect of quality care delivered during an inpatient stay as measured by~     patient/family satisfaction. The investigators will additionally study the affects of the~     intervention on the following outcomes: family assessment of provider communication,~     readmission rates, and length of stay.~   "
173111|NCT01299207|"~     Stents are devices utilized to treat cholesterol blockages of the coronary (heart) arteries.~     The introduction of drug-eluting (coated) stents into clinical practice is regarded as a~     revolutionary breaktrhough, as it has reduced the incidence of re-narrowing of the arteries~     after percutaneous coronary interventions are performed. There has been, however, concerns of~     increased risk for clot formation in the heart arteries of patients treated with drug-eluting~     stents. Therefore, in order to lower the risk of clot formation, it is recommended that~     patients receiving these types of stents, be treated with dual antiplatelet therapy (blood~     thinning medication) for one year. The effect of this strategy, however, on clot formation~     and bleeding complications when utilizing newer generation stents, such as the Xience:~     Everolimus-eluting Stent, have not been well described.~      Therefore, the aim of this registry study is to evaluate the risk of adverse cardiovascular~     events, including mortality, non-fatal myocardial infarction, stent thrombosis, hemorrhagic~     stroke, and severe bleeding in relation to the timing and discontinuation of dual~     antiplatelet therapy in patients treated with Xience drug-eluting stents, and compare it to~     patients that do not discontinue dual antiplatelet therapy.~   "
173112|NCT01299194|"~     Statins are a class of drug used to prevent heart attacks and strokes by lowering blood~     cholesterol levels. They have also been found to have a beneficial side effect of lowering~     the level of inflammation in the body. This is thought to be one of the reasons they are~     effective in treating heart attacks and strokes. Laboratory experiments have shown that~     statins reduce lung inflammation in response to bacteria and this is a promising development~     for the treatment of chest infections.~      Bronchiectasis is a chronic disabling lung disease characterised by chronic sputum production~     and recurrent chest infections. 2/3 of patients are chronically colonised with bacteria~     (normally the lungs are sterile) and this leads inflammation in the lung and in the rest of~     the body.~      There are no effective treatments for bronchiectasis other than antibiotics for chest~     infections. With increasing antibiotic use, there is increasing antibiotic resistance and new~     treatments for this disease are needed.~      The investigators intend to study Atorvastatin in patients with bronchiectasis with~     colonization with pseudomonas aeruginosa. The investigators will give Atorvastatin to 16~     patients with this disease while 16 patients will receive placebo. This will be a crossover~     study where patients will receive atorvastatin or placebo for 3 months, followed by a statin~     wash out period of 6 weeks. Thereafter the groups will cross over and the group receiving~     atorvastatin will now receive placebo and those receiving placebo will receive atorvastatin~     for 3 months. The investigators will measure inflammation in their lungs and in the rest of~     their body before and after treatment with atorvastatin. The investigators will also assess~     their quality of life and number of chest infections over a 7.5 month period.~      This pilot study will determine if there is any role for statins are an anti-inflammatory~     agent in patients with bronchiectasis.~   "
173113|NCT01299181|"~     The investigators hypothesise that long term statin treatment will improve patients' symptoms~     through its anti-inflammatory effect. The beneficial effects on patient symptoms (cough,~     sputum volume, bacterial load, airway function, exercise tolerance, exacerbation frequency~     and health related quality of life) will be consequent on reduced neutrophilic airways~     inflammation.~   "
173114|NCT01299168|"~     The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the~     Banff Classification which represents arbitrary international consensus. Recent data-driven~     approaches using molecular and conventional technologies indicate that mere consensus~     produces frequently incorrect diagnoses with potential harm to patients due to inappropriate~     treatment. To address this unmet need and improve diagnostics in the area of organ~     transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new~     diagnostic system that combines the molecular and histopathological features of transplant~     biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic~     System. The present study will validate and refine this system in 500 prospectively~     unselected biopsies for clinical indications from American, Canadian and European centres in~     addition to 300 biopsies already collected. Due to a considerable interest and support from~     participating Centers, the study is further extended to 1200 prospective biopsies. Thus this~     is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the~     feasibility and value of this System in routine patient care and clinical trials, the study~     will develop and optimize a transparent and user-friendly reporting format to communicate~     this information to clinicians and obtain detailed feedback on how this system can best~     improve patient care.~   "
173115|NCT01299155|"~     To prospectively evaluate postoperative visual and refractive parameters in a series of~     subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with~     LENTIS MPlus Intraocular Lens (IOL).~   "
173116|NCT01299142|"~     The purpose of this study is to determine the safety and tolerability of the anti-TSG101~     human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.~   "
173117|NCT01299129|"~     Purpose:~      To evaluate the effect of intravitreal triamcinolone acetonide (IVTA) on uveitis-associated~     cystoid macular edema (CME) using high resolution optical coherence tomography (SDOCT) in~     conjunction with thorough visual function testing.~      Methods:~      28 patients with uveitis-associated CME were examined before intravitreal triamcinolone~     injection (IVTA) (v1) and at day 1 (v2), week 1 (v3) and month 1 (v4) after injection.~     Retinal anatomy was evaluated using Cirrus HD-OCT (Carl Zeiss Meditec). Visual function~     testing consisted of assessing ETDRS distance visual acuity (VA), reading acuity and reading~     speed using a standardized German-language test (Radner Reading charts), contrast sensitivity~     using Pelli-Robson Contrast Sensitivity charts and fundus-controlled microperimetry using the~     MP-1 Microperimeter (Nidek). Here we utilized a cartesian grid consisting of a central locus~     and three concentric box-shaped stimulation areas. The changes of retinal anatomy over time~     were compared to the respective outcome of visual function.~   "
173118|NCT01299116|"~     In the proposed study, women aged 18-29 seeking oral or injectable contraception will be~     offered an opportunity to try LARC instead; the FDA-approved options include two types of~     intrauterine products and one type of subdermal contraceptive implant. Over a 24 month~     period, the experiences of LARC users will be compared to the experiences of those opting for~     their initial short-acting method.~   "
173119|NCT01299103|"~     The study will enroll and treat a patients to assess improvement in the appearance of facial~     wrinkles.~   "
173120|NCT01299090|"~     Use of RF device to treat wrinkles of the neck~   "
173121|NCT01299077|"~     The purpose of this study is to observe the overall satisfaction of patients with~     degenerative disc disease after receiving triple therapy.~   "
173144|NCT01298778|"~     In previous studies the investigators have seen that the severity of pain one day after~     cesarean delivery can predict the presence of pain and depression 2 months later. The~     investigators believe those at risk for severe acute post-partum pain can be identified, and~     medical interventions can be tailored to manage postoperative pain more effectively.~   "
173145|NCT01298765|"~     The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment~     of chronic pain.~   "
173122|NCT01299064|"~     Preliminary evidence attests to the effectiveness of mindfulness-based interventions in~     reducing symptoms associated with a variety of medical and psychological conditions. However,~     research progress has been hampered by discrepancies in how mindfulness has been~     operationalized, assessed, and practiced. Existing contemporary assessments of mindfulness~     were developed exclusively by Western scientists and have exhibited questionable validity,~     particularly among diverse cultural groups. Operational definitions of mindfulness are~     essential for the development of valid measures, which in turn are necessary for~     investigating the mechanisms of change in mindfulness-based interventions. Therefore, the~     overall goal of this study is to create a mindfulness measure that is informed by the~     experience of mindfulness experts - Theravāda, Tibetan, and Zen Buddhist clergy and lay~     practitioners. To do so, this study will employ the preliminary phases of the sequential~     exploratory mixed methods for instrument design model. The first phase will involve~     conducting open-ended interviews with Theravāda, Tibetan, and Zen Buddhist clergy and lay~     practitioners to ascertain expert information on mindfulness and closely related Buddhist~     concepts. This qualitative process allows the experts to define the phenomena of interest~     (i.e., addresses issues of validity). In the second phase, the investigators will use the~     themes and specific phrases evoked during the qualitative interviews to develop items for a~     draft closed-ended self-report measure of mindfulness. Following completion of the research~     outlined in this proposal, the investigators will submit a subsequent proposal to thoroughly~     evaluate the psychometric properties of our draft mindfulness questionnaire in a variety of~     different cultures and contexts. This measure can be beneficial in clinical research by~     helping to elucidate the mechanisms of change in mindfulness-based psychotherapies in the~     United States and equally so in other cultures such as Thailand, where mindfulness and other~     Buddhist practices have already been integrated into mainstream mental health treatment.~     Therefore, our aim is to create a measure that can help improve the assessment and clinical~     use of mindfulness.~   "
173123|NCT01299051|"~     The proposal of this study is to compare the effectiveness of two worksite weight management~     programs at Duke: Steps to Health (STH) ('usual standard of care') and the more extensive~     Steps to Health Plus! (STH+). We have added an additional follow-up, by invitation only, for~     participants in the study who agreed to be contacted for future research.~   "
173124|NCT01299038|"~     Research studies have shown a strong association between cancer and blood clots in the veins~     (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary~     embolism) which in severe cases may be life threatening. Studies have demonstrated that~     increases in microparticles may contribute to the development of deep vein thrombosis in~     cancer patients. The purpose of this research study is to see if rosuvastatin lowers the~     number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles~     that are generated from different types of blood cells in the body. In people who have~     cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor~     for deep vein thrombosis.~   "
173125|NCT01299025|"~     The aim is to evaluate balance training using Nintendo Wii Fit. The hypothesis is that a~     period of training will increase balance capacity och self-efficacy.~      People with diagnosed multiple sclerosis are invited to participate. Estimation of study~     power gave that 29 people in each group was necessary to detect a difference in the primary~     outcome measure, Timed Up and Go test.~      Other measures used are the Four square step test, Dynamic Gait Index, Timed stands test, 25~     foot walking test, 12-item Walking scale and the ABC scale.~      Participants were randomised to either training or control. The training consisted of 6 weeks~     training with Nintendo Wii Fit 30 minutes 2 times a week.~   "
173126|NCT01299012|"~     Evaluating the use of Liraglutide in patients with Type 1 Diabetes.~   "
173127|NCT01298999|"~     The purpose of this study is to determine whether treatment with an experimental drug called~     YF476 in patients with Barrett's esophagus reduces the expression of tissue markers that are~     associated with an increased risk of developing esophageal cancer.~   "
173128|NCT01298986|"~     Rationale: To determine the most beneficial ablation methodology for individual patients with~     paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as~     surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place~     the epicardial and endocardial ablation lines.~      Objectives: Catheter and surgical ablation are being offered today to patients with drug~     refractory and symptomatic atrial fibrillation. This study is designed to assess the most~     efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation.~     In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein~     isolation performed surgically will be combined with right and left atrial flutter lines~     performed using a transcatheter approach) will be compared to percutaneous catheter ablation~     to isolate the pulmonary veins and apply the left and right atrial flutter lines with removal~     of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the Hybrid~     approach is going to be compared to the minimally invasive Cox-Maze III procedure.~      Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at~     6 months will demonstrate that the Hybrid approach is going to be a: superior to percutaneous~     catheter ablation in the less than 5 cm left atrial group and b: non-inferior when compared~     to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.~      We hypothesize that the safety of all procedures will show no differences and that there will~     be no differences in clinical complications between groups.~   "
173129|NCT01298973|"~     The purpose of this study is to look at the ability of Viscoat to ensure proper wound~     closure.~   "
173130|NCT01298960|"~     Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation~     treatment improves ovarian response in women with previous poor ovarian response.~   "
173131|NCT01298947|"~     The objective of this study is to evaluate the safety and efficacy of preparing a vessel with~     photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local~     Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation~   "
173132|NCT01298934|"~     LBH589 is an oral drug that targets the myelofibrosis cells in the bone marrow and induces~     cell death by allowing for the expression of certain suppressed genes that are important in~     regulating cell survival. Based on laboratory studies, the hypothesis is that this drug will~     selectively kill the stem cells responsible for causing myelofibrosis and result in reduction~     in spleen size and ultimately restoration of normal bone marrow function.~   "
173146|NCT01298752|"~     The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic~     Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following~     cataract surgery.~   "
173147|NCT01298739|"~     Asthma control study 2011~   "
173148|NCT01298726|"~     The purpose of this study is to examine the effect of a pharmaceutical care program on the~     level of glycated hemoglobin for hyperglycemic users of brazilian public health care system~     in drug treatment for type 2 diabetes.~   "
173360|NCT01295892|"~     This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory~     biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese~     women after three months of follow-up intervention.~   "
173133|NCT01298921|"~     Cluster headache is a disorder marked by frequent attacks of short-lasting, severe,~     unilateral head pain with associated autonomic symptoms. It is the most severe head pain~     syndrome known. Currently, the two most common treatments for cluster headaches are inhaled~     oxygen and injectable sumatriptan. These treatments do not work for all cluster headache~     patients, and patients who smoke may eventually develop contraindication to triptans. New~     treatment options are needed.~      An alternative method of oxygen delivery (as opposed to continuous flow) uses a demand valve~     that is controlled by respiration rate, allowing increased oxygen flow in response to~     increased demand. This system may be more efficacious at stopping a cluster headache attack~     than the currently prescribed oxygen delivery system.~      This study will compare the effectiveness of oxygen delivered via demand valve versus~     continuous high flow oxygen via non-rebreather face mask in the acute treatment of a cluster~     headache attack. All patients will treat one cluster headache with each of the 2 treatment~     methods.~   "
173134|NCT01298908|"~     Randomized controlled trial, a method used to implement the random allocation sequence is~     numbered containers.~      The aim of the study is to compare operative treatment, ultrasound guided laser ablation and~     ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great~     saphenous trunks. On the grounds of the available data, the study hypothesis is that using~     laser or operative treatment more than 20 percent better outcome can be achieved compared to~     foam sclerotherapy.~   "
173135|NCT01298895|"~     The purpose of the study was to evaluate optical ocular components in patients with~     pseudoexfoliation syndrome using optical low coherence reflectometry. A prospective cohort~     study of 224 eyes of patients planned for cataract surgery was conducted from January 2009~     until July 2009. Patients were divided in two groups: the first group of 47 eyes with~     cataract complicated with pseudoexfoliation syndrome and the control group of 177 eyes with~     uncomplicated cataract. Each group was further divided into two subgroups based on its~     refractive state: emmetropes and hypermetropes. The optical low coherence reflectometry~     biometer LENSTAR® LS 900® was used to define ocular optical components.~   "
173136|NCT01298882|"~     Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα)~     inhibition with diacerein administration on insulin secretion and metabolic control of~     drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.~      Hypothesis. Diacerein administration improves insulin secretion and metabolic control of~     drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.~      Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial.~     Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements: A~     metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as well~     as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin secretion~     and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for the first 15~     days and twice daily for 45 additional days or placebo. Statistical analyses: Wilcoxon signed~     rank and Mann-Whitney U test.~   "
173137|NCT01298869|"~     Clinical trials have demonstrated the efficacy of HPV-6/11/16/18 vaccination (Gardasil.~     Merck) 3 doses at day 1, month 2, and month 6 to lower the occurrence of high-grade cervical~     intraepithelial neoplasia than did those in the placebo group. The immunogenicity and~     efficacy of the HPV vaccine has not been proven in late stage chronic kidney disease (CKD)~     population. The cellular and humoral immune responsiveness of CKD population are impaired by~     the retention of uremic toxin due to glomerular filtration rate (GFR) reduction, the~     vaccination efficacy can be altered and the effective dose/schedule of the vaccine may need~     to be adjusted, mostly increase in CKD patients.~      This study aims to investigate the immunogenicity of quadrivalent HPV-6/11/16/18 vaccination~     (Gardasil. Merck) by current recommended dose/schedule in CKD stage IV-V patients and compare~     to non-CKD patients. Although a minimal peak anti-HPV response associated with protective~     efficacy has not been determined, the equivalent immune response in CKD and non-CKD patients~     if can be demonstrated by this study should be extrapolated to the CKD population. If less~     immune response results, the more intense dose/schedule of the vaccine should be further~     studied.~   "
173138|NCT01298856|"~     There will be a difference in ankle functional ability between athletes with chronic ankle~     instability in the intervention group and in the control group.~   "
173139|NCT01298843|"~     The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.~   "
173140|NCT01298830|"~     The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with~     space-occupying intracerebral hemorrhage.~   "
173141|NCT01298817|"~     The main objectives of this study are to collect pilot data to assess feasibility (accrual,~     retention, compliance), to estimate the variability of outcome measures, and to obtain~     preliminary estimates of treatment efficacy based on group differences in body composition~     (decreases in ectopic fat stores while maintaining lean mass), cardio-metabolic risk factors~     including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein,~     IL-6), blood pressure and lipids (HDL, LDL, TC, TG), and measures of physical function and~     muscle strength. While this is just a pilot study, randomization will be used so that the~     investigators can obtain a realistic estimate of accrual (which is often less in a randomized~     trial) and an unbiased estimate of treatment efficacy.~      The investigators will accomplish these objectives by conducting a 2-arm, 3-month randomized,~     clinical trial in 24 older (60-79), abdominally obese (BMI ≥30 kg/m2 and waist circumference~     ≥ 102 cm and ≥ 88 cm in men and women, respectively) men and women. Participants will be~     randomized to a soy-based or animal-based, 3-month, hypocaloric dietary intervention to~     achieve our specific aims:~      Primary Aim: To determine our ability to recruit and retain older, obese adults to a 3 month~     soy-based meal replacement weight loss intervention and assess the study participant's~     ability to adhere to the intervention protocol (weight, compliance logs, serum isoflavones).~      Secondary Aims:~        1. To estimate the variability of and obtain preliminary estimates of the effect of the~          soy-based meal replacement on measures of body composition, including abdominal (total,~          subcutaneous and visceral fat), liver, and pericardial fat; anthropometrics (body~          weight, waist/hip circumference); and whole body fat and lean mass.~        2. To estimate the variability of and obtain preliminary estimates of the effect of the~          soy-based meal replacement on biomarkers of cardiometabolic risk including~          glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6),~          blood pressure and lipids (HDL, LDL, TC, TG).~        3. To estimate the variability of and obtain preliminary estimates of the effect of the~          soy-based meal replacement on physical function (short physical performance battery,~          400-m walk) and muscle strength (grip and knee extensor strength) and size (CT thigh~          muscle).~        4. To document any adverse events associated with the soy-based meal replacement.~   "
173142|NCT01298804|"~     Maternal depression disproportionately affects low-income and minority women, and has~     profound negative impacts on their children. The investigators are conducting a randomized~     trial of a systems approach to identify mothers at risk for depression in Head Start - a~     federally funded early learning program for children of low-income families - and to provide~     an on-site intervention to prevent or alleviate depressive symptoms; improve functioning;~     and, where appropriate, proactively link mothers to more definitive mental health services.~   "
173149|NCT01298713|"~     Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation~     anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is~     lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases.~     The Pi3K-AKT-mTor pathway is frequently associated to the hormonoresistance mechanisms. This~     study is aimed to check if the inhibition of this signal transduction pathway by a synthetic~     mTor inhibitor (Everolimus) could improve the efficacy of the Tamoxifen.~   "
173150|NCT01298700|"~     This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution~     compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular~     hypertension.~   "
173151|NCT01298687|"~     The purpose of this study is to compare the incremental dosing of travoprost ophthalmic~     solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in~     patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).~   "
173152|NCT01298674|"~     This is an epidemiological study to assess the the prevalence of Age-Related Macular (ARM)~     Degeneration in Portugal.~   "
173153|NCT01298661|"~     Chronic Obstructive Pulmonary Disease (COPD) leads to a reduction in exercise capacity that~     affects the quality of life and increases mortality of these patients. So, exercise tests are~     considered as an essential component of the clinical evaluation of the patients with COPD.~     The objective of this study is to evaluate the reproducibility sensitivity and validity of~     the Six Minute Step Test (6MST) in patients with COPD and in health volunteers, and verify~     its relation with the Body-Mass Index, Airways Obstruction, Dyspnea and Exercise Capacity~     Index (BODE). This Observational, Transversal, Prospective study will be conducted in the~     Special Unit of Respiratory Physiotherapy, of the Federal University of São Carlos. To~     participate in this study, 120 subjects, both gender, will be invited and will be allocated~     in five groups: Group I (30 healthy young subjects of 17 to 27 years old), Group II (30~     healthy elderly individuals of 60 to 75 years old), and patients COPD, 60 to 80 years old,~     with mild, moderate, severe and very severe obstruction determined by the forced expiratory~     volume in one second (FEV1) by forced vital capacity (FVC) relation FEV1/FVC <70% and FEV1~     in predict percentage < 80% composing the Group III (20 COPD patients in GOLD stage I), Group~     IV (20 COPD patients in GOLD stage II) and Group V (20 patients COPD stages III and IV). All~     subjects will be submitted to body composition and anthropometric assessment, pulmonary~     function test, three 6-minutes walk test (6MWT) and three 6MST. Furthermore, the patients of~     the groups III, IV and V will answer the Modified Medical Research Council (mMRC) scale, and~     BODE index will be calculated to each of them.~   "
173154|NCT01298648|"~     This study will be conducted to assess adverse drug reactions, incidence of adverse events,~     and factors that may affect the safety and effectiveness of Humira for the treatment of~     Crohn's disease.~   "
173155|NCT01298635|"~     Primary angle closure glaucoma (PACG) is caused by contact between the iris and trabecular~     meshwork, which in turn obstructs outflow of the aqueous humor from the eye. This contact~     between iris and trabecular meshwork (TM) may gradually damage the function of the meshwork~     until it fails to keep pace with aqueous production, and the pressure rises, and at last the~     optic nerve is damaged, the vision may be lost in some severe cases. Therefore, ocular~     pressure reduction is the key to treat the disease and prevent blindness. Trabeculectomy is~     the most common conventional surgery performed for glaucoma. This allows fluid to flow out of~     the eye through this opening, resulting in lowered intraocular pressure(IOP) and the~     formation of a bleb or fluid bubble on the surface of the eye.~      Cataract surgery is common in the elderly. Cataract surgery is the removal of the natural~     lens of the eye (also called crystalline lens) that has developed an opacification, which~     is referred to as a cataract. Cataract extraction includes intracapsular cataract extraction,~     extra capsular cataract extraction & phacoemulsification, and phacoemulsification is the~     preferred method. It has been reported that IOP reduction could occur in cataract patients~     with PACG after the cataract surgery. For some cases with PACG, such IOP reduction may be~     insufficient for neuronal protection, and many patients still require glaucoma medication and~     incisional surgery such as trabeculectomy to control IOP. In such cases, a combined~     cataract-glaucoma procedure (phacotrabeculectomy) is a reasonable option. In keeping with~     this concept, previous studies have shown that phacotrabeculectomy could effectively and~     simultaneously reduce IOP and improve vision in patients with a coexistence of PACG and~     vision-threatening cataract. However, phacotrabeculectomy may heighten inflammatory response,~     result in a higher frequency of postoperative complications such as hyphema and fibrin in the~     anterior chamber, endophthalmitis, and increased scarring of the filtering bleb. Thus, it is~     unclear whether phacotrabeculectomy is as effective and safe as trabeculectomy in lowering~     IOP for PACG patients.~      In the present study, the investigators compared the efficacy and safety of~     phacotrabeculectomy and trabeculectomy in patients with coexisting PACG and cataract.~   "
173156|NCT01298622|"~     To investigate the structural/functional abnormalities and the possible genetic~     endophenotypes of Obsessive-compulsive disorder (OCD) patients and their core families.~   "
173157|NCT01298609|"~     The study is designed as a prospective, randomized, double-blind, single center study with a~     6 month duration post permanent system implantation. Forty patients will be implanted.~      During trial stimulation, patients will be randomized into one of two study arms for two~     weeks. Crossover will occur at the 2 week study visit to the opposite group. After completion~     of these two arms, every patient will subsequently complete participation in the third study~     arm.~      After completion of the third arm, patients will be evaluated to determine if they are a~     positive responder responder. If so, the patient will have the option of obtaining the~     permanent implant.~   "
173158|NCT01298596|"~     The purpose of this study is to compare the rate of recurrence of cervical intraepithelial~     neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of~     follow-up and to compare the shedding of HIV-1 from the cervix between HIV-positive women~     receiving cryotherapy versus LEEP over 3 weeks of follow-up.~   "
173159|NCT01298583|"~     The purpose of this study is to compare the improvement in ankle control and brain activation~     in subjects with stroke resulting from two different forms of telerehabilitation: tracking~     training, emphasizing accurate movements, versus movement training, involving simple~     movements.~      Hypotheses:~        1. The Track group will show greater improvement in ankle range of motion compared to the~          Move group.~        2. The Track group will show greater improvement in ankle tracking accuracy and greater~          changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor~          cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent~          (BOLD) signal intensity index) compared to Move group.~        3. The Track group will show greater improvement in tracking accuracy at an untrained joint~          (knee) compared to the Move group.~        4. The Track group will show greater improvement in standing balance.~        5. The Track group will show greater improvement in walking speed and ankle dorsiflexion~          during gait compared to the Move group.~   "
173160|NCT01298570|"~     This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed~     to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI~     (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.~   "
173161|NCT01298557|"~     The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic~     brain injury (TBI) are due to selective disruption of the long association white matter~     tracts of the cerebral hemispheres, with resulting functional impairment of the network of~     cortical regions that are interconnected by these long-range association pathways. We propose~     that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and~     that the impaired cortical activation can be detected with magnetoencephalography (MEG), and~     that the results of these imaging examinations will correlate with neurocognitive status and~     functional recovery after TBI.~   "
173162|NCT01298544|"~     In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received~     either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular~     Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3~     years after the last vaccination) will assess the antibody concentrations in children who~     previously completed Wyeth study 0887X-101518.~   "
173163|NCT01298531|"~     This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of~     etanercept with that of placebo in adult subjects with axial Spondyloarthritis.~   "
173164|NCT01298518|"~     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The~     primary purpose of this trial is to evaluate the safety and tolerability, and~     pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.~   "
173165|NCT01298505|"~     The purpose of this study in healthy people is to investigate the safety, toleration and time~     course of PF-03654764 in the blood, following multiple doses given by mouth together with~     fexofenadine.~   "
173166|NCT01298492|"~     This study provides open-label drug to eligible patients who have completed a prior study of~     PF-00547659. The primary endpoint for this study is long-term safety.~   "
173167|NCT01298479|"~     The purpose of this study is to determine the volumetric delivery of the Uniject.~   "
173168|NCT01298466|"~     A0081256 is a prospective, open-label, multi-centre European study designed to raise~     awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic~     pain component in primary care who are refractory to standard analgesic therapy and/or one~     treatment for neuropathic pain and evaluate the effectiveness and tolerability of pregabalin~     in this population. The impact of pregabalin on analgesia, patient satisfaction with~     treatment, patient anxiety and depression, sleep interference, physical functioning and work~     productivity will be assessed.~   "
173169|NCT01298440|"~     Retinal blood flow velocity is affected by Bevacizump intravitreal injection. This effect is~     correlated to treatment success.~   "
173170|NCT01298414|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is looking at biomarkers in bone marrow samples from young~     patients with acute myeloid leukemia.~   "
173171|NCT01298401|"~     RATIONALE: Monoclonal antibodies, such as ganitumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Specialized~     radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a~     high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage~     to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of ganitumab when~     given together with gemcitabine hydrochloride followed by radiation therapy, ganitumab,~     capecitabine, and maintenance therapy in treating patients with locally advanced cancer of~     the pancreas.~   "
173172|NCT01298388|"~     RATIONALE: Studying medical records and collecting questionnaires from patients who were~     enrolled as children in clinical trials for acute lymphoblastic leukemia may help doctors~     learn about long-term effects of treatment and plan the best treatment.~      PURPOSE: This clinical trial is studying the long-term outcomes of patients with acute~     lymphoblastic leukemia who were enrolled as children on clinical trials EORTC-58741,~     EORTC-58831, EORTC-58832, or EORTC-58881 between 1971 and 1998.~   "
173173|NCT01298375|"~     Type 2 diabetes (T2D) is a global burden disease affecting almost 200 million people and is~     expected to nearly double by 2030 (1). It is imperative that this disease is kept under~     control, and that we begin to reverse the direction of its incidence. We propose to start by~     identifying the physiological and molecular aspects of the problem in all spectrums of the~     disease (ie from insulin sensitive athletes to sedentary lean and obese individuals and~     further to overt type 2 diabetics), and focus our efforts on examining the differences and~     identifying the stages of progression for possible targets of future intervention. The~     proposed study Metabolic Phenotyping is novel in its target populations and innovative in~     its use of state-of-the-art techniques. We hypothesize that the in vivo differences in~     metabolic flexibility and mitochondrial function between endurance athletes and type 2~     diabetics and their lean and obese controls are retained in vitro and will offer a new model~     in which to study the underlying mechanisms of the progression of T2D.~   "
173174|NCT01298362|"~     The purpose of this study is to identify the combined impact on bone loss as well as the~     incidence of bone fractures in women with estrogen receptor (ER)-positive, early breast~     cancer treated with an aromatase inhibitor (AI) either as first line therapy or as~     maintenance therapy after initial treatment with chemotherapy, in real life clinical settings~     in Greece.~   "
173199|NCT01298037|"~     This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort~     Study NCT01263587. This study will examine the balance between immune regulatory and effector~     responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).~   "
173200|NCT01298024|"~     The purpose is to study the effect of early NEuroMuscular EXercise (NEMEX) versus~     conventional treatment (late exercise) in patients with acute non-operative achilles tendon~     rupture (ATR).~   "
173201|NCT01298011|"~     The main purpose of this research study is to evaluate whether Abraxane and gemcitabine are~     effective in treating patients with operable pancreatic cancer.~   "
173202|NCT01297998|"~     To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus~     cisplatin combination therapy in patients with biliary tract cancer undergoing resection~     without major hepatectomy.~   "
173175|NCT01298349|"~     The present study aimed to examine face and object perception processes in schizophrenic~     patients. Schizophrenia is associated with deficits in visual processing that represent a key~     feature in the disorder. Previous studies have shown that schizophrenics exhibit deficits in~     a variety of facial-processing tasks (e.g., face recognition, recognition of facial~     expressions), that may severely hinder the patients' interpersonal and social skills. Some~     investigators have attributed these deficits to impairments in configural processing in~     schizophrenia. That is, an impairment in the ability to process the spatial relations between~     the constituent parts of a configuration (e.g., the spacing between the eyes of a given~     face). To date, studies aimed to investigate this possibility (e.g., Schwartz et al., 2002;~     Yong-Wook et al., 2008) yielded conflicting results. Additionally, it is not yet clear~     whether the hypothesized impairment in configural processing is restricted to faces, or~     whether it is more general in nature and applies to objects as well.~   "
173176|NCT01298336|"~     The purpose of this study is to determine the 6-months sputum conversion rate with a~     clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary~     infection.~   "
173177|NCT01298323|"~     The purpose of this study is to evaluate the effect of patient outreach program on the~     proportion of time patients with MTC experience moderate or severe AEs during first 12 months~     of treatment with vandetanib~   "
173178|NCT01298310|"~     To characterize the phenotype in patients with Morton's neuroma and to explore the effect of~     local administration of Xylocaine (lidocaine)~   "
173179|NCT01298297|"~     The purpose of this study is to determine whether sublingual buprenorphine is effective in~     the treatment of acute pain in adult patients with extremity bone fractures~   "
173180|NCT01298284|"~     New strategy to improve the outcomes in patients with HCC and acute variceal bleeding. NSBB~     added to endoscopic ligation may further reduce rebleeding in cirrhotic patients.~   "
173181|NCT01298271|"~     Design a randomized trial to compare the effect of endoscopic cyanoacrylate injection~     obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal~     bleeding.~   "
173182|NCT01298258|"~     The investigators hypothesize that the different components of arterial load are coupled with~     different components of LV function. The regional ventriculo-arterial couplings may be~     important in the pathogenesis of heart failure and ventricular remodeling, and in the~     prediction of future cardiovascular events.~   "
173183|NCT01298245|"~     The primary purpose of the study is to investigate allele frequencies of candidate genes in~     Chinese diabetic patients with or without known diabetic retinopathy. Two hundred Chinese~     diabetic patients, aged between 20 - 75 years old, who have received ophthalmic fundus~     examination (either by an ophthalmoscope or fundus camera) within 6 months before the study~     will be recruited for the study. Each subject will receive anthropometric and blood pressure~     measurements. Then, fasting blood samples will be taken for the measurements of glucose,~     HbA1c, lipid profile, and biochemistry. An additional 10 ml blood sample will be taken for~     DNA extraction from buffy coat. Meanwhile, the participant will receive structural~     questionnaires for demography, personal history, medical history and concomitant medication.~     Single nucleotide polymorphisms (SNPs) in candidate genes and in targeted chromosome regions~     will be genotyped by using the ABI TaqMan assays. The differences in the distribution of~     genotypes and alleles between the study groups will be analyzed using appropriate statistical~     methods. Through the study, the investigators hope to build up a platform for future~     large-scale genetic studies of diabetic retinopathy. The investigators also hope to set up~     priority of candidate loci for future studies.~   "
173184|NCT01298232|"~     Left ventricular systolic time intervals, including pre-ejection period (PEP), ejection time~     (ET), and their ratio (PEP/ET), is determined by the systolic and diastolic function and~     ventriculo-arterial coupling. The investigators have shown the usefulness of the~     electromechanical activation time (EMAT, equals PEP minus isovolumic contraction time) in the~     prediction of cardiac mortality or re-hospitalization for heart failure in patients with the~     acute heart failure syndrome (AHFS). Therefore, the objective of the present proposal is to~     compare 12-month outcomes of EMAT-guided vs symptom-guided heart failure therapy in patients~     with AHFS.~   "
173185|NCT01298219|"~     The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone~     administration in subjects with~      OBD.~   "
173186|NCT01298206|"~     The pandemic A/H1N1 virus was named swine flu when the current outbreak started. Although~     it is not yet confirmed that the index case acquired the virus from pigs, the nomenclature~     swine flu was due to the fact that the virus is triple-reassortant with genes from swine,~     avian, and human influenza origins. A total of 57,809 cases were reported in the WHO EMRO~     region, 693 of whom have died (1.2% case fatality). Lebanon had 1,838 confirmed cases with 5~     deaths, it is estimated that 4% of these cases required hospitalization. Most cases of~     pandemic influenza presented with fever, cough, and sore throat. Other common symptoms~     included myalgia, headache, and rhinorrhea. The pandemic A/H1N1 virus appears to be very~     successful at human-to-human transmission. It is also causing infections beyond the~     traditional seasonal variation of previous human influenza viruses. Unlike seasonal influenza~     viruses that usually cause severe infections requiring hospitalization among the elderly and~     children under 5 years old, the pandemic A/H1N1 viruses are causing more severe illness among~     young adults. Several reports have associated certain underlying conditions with severe~     illness. Such conditions were pregnancy, asthma, diabetes, obesity, and heart disease.~   "
173216|NCT01297816|"~     This process appears as a incredible and progressive event that will not stop till~     reattachment of RPE and neurosensory retina happened .~      Process of degeneration begins from first hours of RD (Retinal Detachment) establishment~     Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered~     in recent years .~      How to stop this phenomena and neuroprotective agent role in this issue are a new interest of~     researcher.~      In the study the investigators are planning to perform a clinical trial to demonstrate the~     minocycline neuroprotective effect in a double blind design as this impact has been~     implicated previously in a animal study~   "
173260|NCT01297218|"~     The primary purpose of this study is to evaluate the safety and the tolerability of~     NEUROSTEM®-AD (Human Umbilical Cord Blood Derived Mesenchymal Stem Cells) and to assess the~     maximum tolerated dose (MTD). This study is also to investigate the efficacy of this study~     drug in patients with dementia of Alzheimer's type.~   "
173187|NCT01298193|"~     This is a prospective, multicenter, open label, non-comparative trial in Spain.~      The primary objective of this study is to determine the complete response, defined as no~     vomiting and no use of rescue treatment, in women with early-stage breast cancer treated with~     one cycle of Docetaxel-Cyclophosphamide and active therapy for the prevention of~     CINV(Chemotherapy-induced nausea and vomiting) day 1, 5-HT3 antagonist plus 3 days of~     dexamethasone. A second step (efficacy phase) is designed to examine the efficacy and~     tolerability of aprepitant in the second cycle among patients who failed to the previous CINV~     prevention treatment.~      The study will focus on early-stage chemonaïve breast cancer patients receiving~     docetaxel-cyclophosphamide and a 5-HT3 antagonist plus dexamethasone for the CINV prevention.~     The CINV incidence in those patients will be evaluated on the first cycle. All refractory~     patients, will be asked to participate in the second phase, where aprepitant on days 1, 2 and~     3 will be added to their antiemetic regimen.~      Assuming a drop out of 5%, 212 patients will be included in the study. It is anticipated that~     around 48 patients will enter the efficacy phase.~      The duration of the study, from first patient visit to last patient visit will be~     approximately 21 months.~   "
173188|NCT01298180|"~     The purpose of this study is to estimate the sensibility at the growth hormone in vivo at the~     children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a~     deficit in growth hormone (GHD).~   "
173189|NCT01298167|"~     The purpose of the study is to look at which nonpermanent superficial closure method,~     cyanoacrylate tissue glue or fast absorbing gut suture, leads to a better cosmetic and~     functional outcome in repairs of facial wounds after Mohs surgery.~   "
173190|NCT01298154|"~     The purpose of this protocol is to study the effects of intact and hydrolyzed yellow pea~     protein, compared to intact and hydrolyzed whey protein, on satiety, food intake, and glucose~     metabolism in healthy young men. The specific objective is to investigate the effects of 20 g~     available protein for 4 different protein types (intact and hydrolyzed pea and whey proteins)~     and water (control) on satiety, food intake and blood glucose before and after a meal. The~     specified amount of protein was chosen based on our previous studies on intact pea protein~     suggesting that 20 g may reduce food intake and pre-meal blood glucose 30 minutes before a~     test meal. Whey protein has been chosen as a reference protein because it has been~     extensively studied and its effects on blood glucose and food intake are being elucidated~     within our laboratory.~   "
173191|NCT01298141|"~     The purpose of this study is to observe the safety of agalsidase alfa in Canadian patients~     with Fabry disease.~   "
173192|NCT01298128|"~     The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and~     medications are delivered locally. It has been proven to be as safe and effective as the~     combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to~     minimal systemic absorption. Following a single vaginal insertion, steroid concentrations~     remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to~     better compliance, tolerability and acceptance by patients requiring ovarian suppression~     prior to COH for IVF.~   "
173193|NCT01298115|"~     This prospective observational study is designed to find out what treatment options new~     patients with chronic kidney disease learn about from their renal unit.~      Aims: To determine the proportion of new CKD patients who receive information about treatment~     options prior to commencing dialysis, pre−emptive transplantation or conservative management.~     To determine the timing (i.e. patient's stage of disease) when information is given. To find~     out whether patients have a friend or family member with them when information is given.~      Research Design and methods: This study is an assessment of CKD education practices.~     Nephrologists and pre−dialysis coordinators from each renal unit will complete questionnaires~     about information that was given to each new dialysis, pre−emptive transplant or~     conservatively managed patient that started treatment during a 3 month period.~      Study hypothesis: Approximately one third of CKD patients will receive information after~     starting treatment. There will be a positive association between in−centre haemodialysis and~     later referral, non−English speaking background, and advancing age. Significance: The results~     from this national audit will provide Australian nephrologists and renal nurses with evidence~     about CKD education practices and compliance with clinical practice guidelines. The results~     may highlight opportunities for improvement in practice.~   "
173194|NCT01298102|"~     In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about~     vaccination. There is no data concerning the immunogenicity nor the security of the~     adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the~     effects of this vaccine on transplanted and hemodialyzed patients.~   "
173195|NCT01298089|"~     A study of flap thickness predictability in patients submitted to Laser in Situ~     Keratomileusis (LASIK) with the Carriazo-Pendular microkeratome (130 micrometers head size).~   "
173196|NCT01298076|"~     The specific aims of the study are to test the following hypotheses:~        -  That there is a difference in change in visual acuity resulting from treatment with~          intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced~          macular oedema~        -  That there is a difference in degree of resolution of macular oedema resulting from~          treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with~          advanced macular oedema~        -  That both intravitreal bevacizumab and dexamethasone implants have a manageable and~          acceptable safety profile in eyes with diabetic macular oedema~   "
173197|NCT01298063|"~     Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at~     highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose~     or two lower doses) and 8 healthy matched controls to each of this two groups.~   "
173198|NCT01298050|"~     Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival~     rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted~     the potential early application of this method in improving the prognosis of prolonged~     cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale~     for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the~     cause of CA and waiting for the recovery of the injured myocardium. The investigators have~     created a flow-chart to decide which patients are eligible. The aims of this study are to~     evaluate if, with this flow-chart, the investigators are able to detect which patients have~     more probability of survival.~   "
173203|NCT01297985|"~     This randomized controlled trial tests the efficacy of a mental health peer-led educational~     intervention called BRIDGES (Building Recovery of Individual Dreams and Goals through~     Education and Support). The BRIDGES program is a 10-week, manualized education course~     designed to provide basic information about the etiology and treatment of mental illness,~     self-help skills, and recovery principles in order to empower participants to return to~     valued social roles within their communities. BRIDGES is a peer-led program and all~     instructors are adults with mental illnesses.~      Hypothesis #1: Compared to wait-list controls, intervention participants will report~     increased feelings of psychological empowerment.~      Hypothesis #2: Compared to wait-list controls, intervention participants will report~     increased feelings of hopefulness.~      Hypothesis #3: Compared to wait-list controls, intervention participants will report enhanced~     coping ability.~      Hypothesis #4: Compared to wait-list controls, intervention participants will report enhanced~     recovery.~      Hypothesis #5: Compared to wait-list controls, intervention participants will report greater~     ability to advocate for themselves with health care providers.~      Hypothesis #6: Compared to wait-list controls, those in the BRIDGES education course will~     report increased knowledge of the causes and treatment of mental illness and recovery~     principles.~   "
173204|NCT01297972|"~     Mesenchymal stem cells have been tested in many autoimmune disorders with encouraging results~     and may be an alternative to the treatment of immune-mediated severe acquired aplastic~     anemia.~   "
173205|NCT01297959|"~     This study is intended to determine the efficacy of topical application of E-101 Solution~     directly into the surgical incisional wound in the prevention of infection of superficial and~     deep surgical incisional wounds. E-101 Solution is an enzyme-based antiseptic that is being~     developed for direct application to a surgical incision.~   "
173206|NCT01297946|"~     Recent developments of continuous glucose sensors and insulin infusion pumps have motivated~     the research toward closed-loop strategies to regulate glucose levels in patients with type 1~     diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a~     computer-generated recommendation that relies on continuous glucose sensor readings. In this~     study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop~     strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII)~     therapy in regulating glucose levels during an evening exercise and on a night following an~     exercise in adults with type 1 diabetes.~   "
173207|NCT01297933|"~     A compassionate use protocol to provide Omegaven to pediatric patients with parenteral~     nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).~   "
173208|NCT01297920|"~     The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic~     suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual~     active components in subjects with open-angle glaucoma and/or ocular hypertension.~   "
173209|NCT01297907|"~     Background: Latent pulmonary involvement is described in Crohn Disease(CD). Bronchial~     hyperreactivity measured by the Methacholine Challenge Test (MCT) has been evaluated in two~     studies involving mainly adults.Our aim was to determine the frequency of bronchial~     hyperreactivity in pediatric patients followed and treated for Crohn disease.~      Methods: Twenty-three children with Crohn disease completed a questionnaire, followed by~     spirometry, Methacholine Challenge Test (MCT) and determination of Fractional Exhaled NO~     (FENO). The control group included patients evaluated for functional cough who had negative~     Methacholine Challenge Test (MCT).~   "
173210|NCT01297894|"~     In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to~     mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative~     bacterial including MDR A. baumannii In this study, we compare the clinical and~     microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A.~     baumannii infected patients~   "
173211|NCT01297881|"~     Pulmonary function tests including spirometry, lung volumes, measurements of resistance and~     diffusing capacity are essential in the diagnosis of several pulmonary diseases. These tests~     are an integral part of the diagnosis and treatment of lung diseases, but until now there is~     no clear evidence for the use of many of the pulmonary function tests because of a lack of~     adequate studies. The obscurity largely pertains to the conditions under which combinations~     of the various tests are indicated. Therefore the Belgian Thoracic Society, assembling all~     pulmonologists and the pneumology LOK/GLEM‟s, will investigate this matter.~   "
173212|NCT01297868|"~     Objective The investigators assessed the acute impact of physical exercise on retinal vessel~     regulation. This might be of clinical importance if retinal vessel regulation is examined~     with the very sensitive method of the dynamic vessel analyzer Design Forty middle aged (age~     range 18 to 31 years, mean age 24 years) healthy subjects (26 female / 14 male) had retinal~     examinations with static and dynamic vessel analysis prior and after (0.5h, 1.5h, 2.5h)~     intense exercise of 20 minutes.~   "
173213|NCT01297855|"~     In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa~     contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin.~      In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to~     receive Colistin alone and another group will receive Colistin plus Rifampicin.~   "
173214|NCT01297842|"~     Adult patients with ESBL-producing Gram negative infections are randomized to receive~     ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups~     are compared.~   "
173215|NCT01297829|"~     Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic,~     anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV~     antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate~     route for administration of ibuprofen when the oral route is not preferable. Recent studies~     have reported that Caldolor® decreases morphine use and pain at rest and with movement~     compared to patients not receiving this drug.~      The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30~     minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical~     hernia repair will result in a >20% decrease in postoperative narcotic use within the first~     24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days~     after surgery. The use of less postoperative narcotics has been associated with a faster~     return of normal bowel function and resumption of normal ambulatory status thus resulting in~     improved general well being for the patient.~   "
173217|NCT01297803|"~     Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results~     and better control of intraocular pressure complications such as corneal endothelial cell~     loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap~     dissection. Mitomycin_c application after sclera flap dissection probably increases corneal~     endothelial cell loss. This study compares Mitomycin_c application two methods: before and~     after sclera flap dissection with regard to success rate and complication. patients on base~     of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups(~     before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism,~     polymegathism and intraocular pressure before and one month, three months, six months after~     surgery will measured.~   "
173218|NCT01297790|"~     The sensitivity of a persons cough reflex can be measured by getting them to breath in~     (inhale) irritant chemicals. The purpose of this clinical research study is to test the~     sensitivity of the cough reflex to a variety of chemicals that can be inhaled to see if~     coughing responses are different between healthy people and people with respiratory problems~     that make them cough.~   "
173219|NCT01297777|"~     The aim of this study is to evaluate the efficacy in terms of clinical and biological~     response rates of Imatinib Mesylate therapy in patients with systemic mastocytosis lacking~     KIT mutations.~   "
173220|NCT01297764|"~     This study will evaluate the feasibility of combining four of the most active agents~     available for the treatment of multiple myeloma. Further the investigators will attempt to~     assess the activity of this combination.~   "
173221|NCT01297738|"~     Obesity and insulin resistance may be in part explained by an altered reward system with~     changes in the serotonin/dopamine system. These changes might be caused by changes in dietary~     habits, especially by an increased intake of liquid sugar and an increase in meal frequency.~     The investigators hypothesize that increasing meal frequency compared to increasing meal size~     and when consuming a hypercaloric high-sugar diet (HS) compared to a hypercaloric~     high-fat-high-sugar diet (HFHS) will result in a reduction in cerebral serotonin and dopamine~     transporters and in a more prominent increase in insulin resistance. In addition, the~     investigators hypothesize that the changes in insulin sensitivity will be independent of~     changes in abdominal (visceral) and liver fat and that changes in insulin sensitivity due to~     the dietary manipulation will co-occur with changes in insulin signaling pathways in~     peripheral fat and muscle tissue.~   "
173222|NCT01297725|"~     The purpose of this study is to compare sharp and blunt fascial entry during caesarean~     section on the same patient. The study is performed on woman having cesarean section for the~     first time and who have not previously had lower abdominal surgery done. The following~     parameters are registered:~        1. The preferred side evaluated by the patient 3 months postoperatively.~        2. The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and~          1 and 3 months postoperatively.~        3. The rate and side of infection.~   "
173223|NCT01297712|"~     Polyps found during screening colonoscopy have to be removed or at least biopsied. Attempts~     to save costs include endoscopic assessment of polyps with regards to differential diagnoses~     between adenomas (which have to be removed) and hyperplastic polyps (could be left in place~     or removed and not examined histologically). Such a concept would only be feasible if~     endoscopy can make the differential diagnosis with high accuracy. Such high accuracy rates -~     between 80% and 95% - have been reported from reference centers with specific scientific~     interest. The investigators want to test whether these results a) can be reproduced in the~     private practice setting performing large-volume screening colonoscopies and b) whether~     latest generation endoscopes provide benefit in terms of better accuracy.~   "
173224|NCT01297699|"~     The purpose is to investigate tocilizumab administration in patients with moderately to~     severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with~     corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic~     alternative.~      The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment~     in order to provide a better alternative to surgery for this patients.~   "
173225|NCT01297686|"~     Chronic plantar fasciopathy is a painful condition common in the workplace, particularly for~     those workers required to stand for long periods of time, and is typically associated with~     point tenderness at heel and arch of the foot. This clinical trial will investigate the~     effectiveness of an innovative multi-element exercise program versus the standard of care for~     plantar fasciopathy. The observation period will be 12-weeks. Outcomes are determined through~     questionnaire and ultrasound imaging. Workers with long-standing plantar fasciopathy who must~     stand for prolonged periods of time (i.e. > 6 hours) during their workday will be invited to~     participate in this study. After ensuring eligibility, each subject will be randomly assigned~     to either the intervention group who will receive a multi-element exercise program, or the~     control group who will receive a cortisone injection followed by a stretching program for~     their calf-muscles (standard of care). The treatment length for both groups will be 12-weeks.~   "
173226|NCT01297673|"~     The purpose of this study is to investigate the incidence of reflux in patients with spinal~     cord injury in relation to the lesion level, duration of injury and bladder management~   "
173227|NCT01297660|"~     Most patients with spinal cord injury suffer from bladder dysfunction which may - especially~     in the long-term - impair renal function. Improved treatment during the last decades improved~     life expectancy and quality of life. This study evaluates the bladder function in the~     long-term after spinal cord injury.~   "
173228|NCT01297647|"~     The purpose of this study is to evaluate the incidence of urinary tract infection after~     urodynamic investigation and to identify the involved germs.~   "
173229|NCT01297634|"~     This study evaluates the diffusion area (cephalic, lateral, medial and caudal points) of the~     botulinum toxin type A in the frontal muscle for usual concentrations and dilutions of the~     drug. A basal line control and After the application control will be made, and the~     investigators will evaluate the drug effects, based on clinical aspects, photographic~     registers and through electromyography exam (EMG).~      Considering the results of our investigation, the investigators may propose a pattern of~     application of BOTULINUM TOXIN TYPE-A Botox® in the frontal area.~   "
173230|NCT01297621|"~     This prospective controlled trial was designed to determine whether breast reduction may~     influence physical activity and sexuality of breast hypertrophy women.~   "
173232|NCT01297595|"~     This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over~     single-dose study employing administration of two oral formulations of crizotinib (OLF and~     FC) in the fasted state to healthy adult subjects. Twenty-two (22) subjects will be enrolled~     to obtain at least 20 evaluable subjects who complete the study. Each subject will receive~     two treatments (A and B) with a washout period of at least 14 days between each treatment.~   "
173233|NCT01297582|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-6950~     across ascending single doses in healthy adult male and female subjects. The secondary~     objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950~     by measuring plasma concentrations of ONO-6950, pulmonary function, and potential~     cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a~     meal upon the pharmacokinetic profile of ONO-6950.~   "
173234|NCT01297569|"~     This study is designed to explore a more individualized treatment regime based on achievement~     of disease stability to define a personal optimal treatment interval with ranibizumab in~     patients with visual impairment due to diabetic macular edema.~   "
173235|NCT01297556|"~     The purpose of this study is to determine if any specific patient characteristics lead to~     improved outcome of IBS treatment, when conventional treatment as well as Cognitive~     Behavioral Therapy is used in combination.~   "
173236|NCT01297543|"~     Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to~     accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in~     patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid~     leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this~     study, the safety, tolerability and activity of CLT-008 administered after standard of care~     cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by~     monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD),~     neutrophil and platelet recovery, hMPC persistence, infections and complications.~   "
173237|NCT01297530|"~     This is the first study of this drug in human beings. Every patient will receive the drug,~     there is no placebo group. Patients with advanced tumors will be treated. Different groups of~     patients will receive different dosages to determine the safety and maximum tolerated dose~     (MTD) of BAY87-2243. The study will also assess how the drug is metabolized by the body, its~     biologic effects in the body, and changes in tumor size.~      BAY87-2243 will be given as a tablet which dissolves in the gut. Based on findings from this~     study it may be later given as a tablet which dissolves in the stomach.~      BAY87-2243 will be given per mouth, once a day, every day. Treatment will stop if the tumor~     continues to grow, if side effects occur which the patient can not tolerate or if the~     patients decides to exit treatment.~      The study will be conducted in 3 - 4 centers in 3 countries (Norway, United Kingdom and~     Germany). The study will have a part where doses are escalated in different groups of~     patients. Each dose level will be evaluated in a new group of 3 - 6 subjects. This will be~     followed by an extension part where patients are treated at the highest tolerable dose in~     groups of up to 25 patients. The extension part will be described in an amendment to the~     study protocol later. The number of subjects estimated for this study will depend on the~     number of groups enrolled. The starting dose will be 5 mg given orally as a tablet~     formulation.~   "
173238|NCT01297517|"~     The purpose of this study was to evaluate the efficacy and safety of a fixed combination of~     Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its~     individual active components in patients with open-angle glaucoma and/or ocular hypertension.~   "
173239|NCT01297504|"~     The study was designed to gather information regarding the use of palivizumab for the~     prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected~     countries within Latin America.~   "
173240|NCT01297491|"~     The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured~     by determining the progression free survival (PFS), in patients with pretreated metastatic~     Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be~     investigated in two groups of NSCLC patients according to the histology of the cancer:~     squamous and non-squamous.~   "
173241|NCT01297465|"~     This is a multicenter, multi-national, randomized, open-label comparative trial. After~     screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle.~     Down-regulation treatment will start within 2 months following the screening visit. The~     routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist~     treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be~     performed just before randomization and start of recombinant human follicle-stimulating~     hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative,~     the subject will be randomly assigned to one of the two treatment arms of the trial:~        -  GONAL-f®: (Liquid Pen; 300 international unit [IU] of per day) stimulation Day 1-5~          followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until~          required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be~          adjusted from stimulation Day 6 (increased or decreased) based upon the subject's~          ovarian response and according to the center's standard practice.~        -  Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required~          r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or~          decreased) based upon the subject's ovarian response and according to the center's~          standard practice.~      Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular~     development will be monitored according to the center's standard practice by ultrasound (US)~     and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one~     follicle greater than or equal to [>=] 18 millimeter [mm] and two follicles >=16 mm). After~     this, a single injection of r-hCG will be administered in order to induce final oocyte~     maturation.~      At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally~     under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days~     after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET)~     and luteal support will be performed as per center's standard practice.~      A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant~     and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment~     (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take~     place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding~     pregnancy testing).~   "
173242|NCT01297452|"~     The purpose of this study is to find out the good and bad effects that occur when BKM120 is~     added to standard chemotherapy with carboplatin and paclitaxel.~   "
173259|NCT01297231|"~     Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and~     decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These~     women also commonly have breast MRI to monitor for breast cancer. Some features of normal~     breast tissue visible on breast MRI change depending on patient hormonal status. It has been~     questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests~     this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could be~     done looking at whether breast MRI could tell us anything about whether tamoxifen is working.~      This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will~     also look at if other factors like taking anti-depressants or gene type have any effect.~   "
173243|NCT01297439|"~     Shoulder dystocia is a major obstetric emergency defined as a delivery requiring maneuver in~     addition to downward traction on the fetal head for delivery of the shoulders. Shoulder~     dystocia is a major obstetrical complication, occurring in approximately 0.2 to 3% of~     deliveries, principally due to fetal macrosomia. The obstetrical and neonatal complications~     associated with shoulder dystocia include newborn mortality occurring in 21 to 290 per 1000~     deliveries, generalized asphyxia, fractures, neurological damages (brachial plexus injury)~     and hematoma. The objective of this study was to evaluate the pushing maneuver, that is~     performed gently on the fetal head since the crowning of the head (appearance of the fetal~     scalp at the introitus between pushes), aiming to facilitate the anterior shoulder to slip~     off behind the symphysis pubis, reducing thus the risk of shoulder dystocia. This preventive~     maneuver may reduce the power (energy/time unit) exerted on the perineal tissues and give the~     shoulders time to enter the pelvic cavity. The pushing maneuver will be evaluated in~     comparison with either an expectative attitude or a suctioning of fetal nose and mouth.~   "
173244|NCT01297426|"~     Obesity does not respond to high circulating levels of the hormone leptin. This study is~     aiming at finding out why this happens and open new avenues for treatment of obesity.~   "
173245|NCT01297413|"~     The purpose of this study is to assess the safety and tolerability of allogeneic adult~     mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.~   "
173246|NCT01297400|"~     The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment~     of subjects with partial thickness burns.~   "
173247|NCT01297387|"~     This observational prospective study will evaluate, according o usual local clinical~     practice, feasibility of endoluminal revascularization in diabetic patients with type C and D~     lesions, according to TASC II Criteria.~      About 300 patients will be treated with usual revascularization procedure. Each patient will~     be followed at least 12 months to evaluate clinical outcome and limb salvage interventions.~   "
173248|NCT01297374|"~     The purpose of this study is to compare the effect of three different non-pharmacological~     interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical~     activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the~     percentage of body fat and basal metabolism of children and Overweight and obesity in the~     metropolitan region of Porto Alegre (RS).~   "
173249|NCT01297361|"~     Vitamin B12 deficiency is more widespread in the population than has been assumed so far.~     Since a deficiency in this vitamin can lead to irreversible neurological damage, early~     diagnosis is essential. Vitamin B12 is synthesized exclusively in micro-organisms, and in~     humans it is an essential component in methyl group transfer and cell division. The vitamin~     is crucially involved in the proliferation, maturation, and regeneration of neural cells. In~     combination with folic acid, as an enzymatic essential cofactor in the metabolism of~     homocysteine, vitamin B12 maintains low homocysteine levels. The aim of the present study is~     to investigate the relationship between religious origin and age, and Vitamin B12 and Folic~     acid plasma levels in non Jewish population in Western Galilee. The investigators assumption~     is that the results of the study will contribute to early detection and treatment of Vitamin~     B12 and Folic acid deficiencies in order to prevent long term complications.~   "
173250|NCT01297348|"~     Lybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl~     estradiol (90 μg/20 μg). Lybrel is taken on a continuous basis without a placebo or pill-free~     interval to inhibit menstrual cycle bleeding by delivering a steady level of the 2 hormones~     for as long as the drug is used. Lybrel was marketed in the US in July of 2007. The objective~     of this database case-control study is to estimate the risk of idiopathic VTE (deep vein~     thrombosis and pulmonary embolism) in current users of Lybrel (ethinyl estradiol~     20ug/levonorgestrel 90ug) compared to current users of other oral contraceptives containing~     20μg of ethinyl estradiol.~   "
173251|NCT01297335|"~     The purpose of this study is to determine the acute efficacy of intrathecal clonidine to~     reduce blood pressure in hypertensive subjects with poor blood pressure control and describe~     its effects on cardiovascular function.~   "
173252|NCT01297322|"~     The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva~     VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis:~     The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA)~     results that are less than manual compression by a clinically meaningful and statistically~     significant margin. The rate of major access site-related complications with the Cardiva~     VASCADE™ VCS is non-inferior to the major complication rates of manual compression for~     sealing femoral arterial access sites.~   "
173253|NCT01297309|"~     This study is a long-term, open-label study using NPSP558 for the treatment of adult patients~     with Hypoparathyroidism.~   "
173254|NCT01297296|"~     The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant~     and Delivery System in the partitioning of the left ventricle in patients with heart failure~     due to ischemic heart disease.~   "
173255|NCT01297283|"~     The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta~     CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from~     the device programmer (PECG) or an external ECG machine.~      The purpose of the study is to obtain more data on leadless ECG to determine whether LECG~     during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it~     can be used during remote follow-up evaluations.~   "
173256|NCT01297270|"~     The objective of this trial is to evaluate the efficacy and safety of two different treatment~     regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care~     (SOC) with PegIFN/RBV alone.~   "
173257|NCT01297257|"~     The primary objective of the DELIVER Study is to assess the deliverability of the Resolute~     Integrity Stent as primary stent or as a secondary cross-over stent following delivery~     failure of another stent type in real world patients.~   "
173258|NCT01297244|"~     This is an open-label, single arm, multicenter study. Subjects will be stratified by~     histology (clear cell vs. non-clear cell). Enrollment of non-clear cell subjects will be~     limited to ≤ 30% of the entire study population.~   "
173261|NCT01297205|"~     PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended~     to treat premature infants with bronchopulmonary dysplasia. This study is to assess the~     safety and the efficacy of this study drug.~   "
173266|NCT01297140|"~     Alzheimer's disease is characterised by a loss of cognitive functions and behavioural~     problems as set out under the term Behavioural and psychological symptoms of dementia~     (BPSD). The impact of BPSD in everyday life has heavy consequences for the patient and their~     family. The precocity of incidence, the frequency and the intensity of the BPSD are~     associated with a rapid decline in cognitive functions, an alteration in the activities of~     daily living, and a decrease in the quality of life for both the patient and the helper, an~     increased risk of hospitalisation and of institutionalisation as well as an increase in the~     cost to the health system. A greater understanding of the risk factors for the occurence of~     the BPSD would better allow the detection of patients who are particularly at risk for BPSD,~     to anticipate the crisis situations by proposing early and adapted care, and to better target~     the medicinal therapies. Certain observational arguments or results of retrospective studies~     speak in favour of the role of the basic personality in the occurence of BPSD in Alzheimer's~     disease. The investigators propose to clarify this role through a prospective study.~   "
173267|NCT01297127|"~     This prospective observational study will evaluate predictors of response to Invirase~     (saquinavir) treatment in treatment-naïve patients with HIV infection. Data will be collected~     during 48 weeks of treatment.~   "
173268|NCT01297114|"~     This investigation is designed to study how the brain functions when it is performing~     explicit memory tasks, and furthermore how the brain systems supporting performance on these~     tests change as a function of aging. Implicit memory tasks may be distinguished from explicit~     memory tests in that explicit memory characterizes the directed or intentional recollection~     of previously learned information or events. In contrast, implicit (or nonconscious) memory~     is expressed in the facilitation of performance on some task or judgment on a stimulus owing~     to a prior presentation of that stimulus, without any necessary conscious awareness of the~     prior presentation. The investigators propose to use functional Magnetic resonance Imaging~     (fMRI) to measure brain activity during the performance of carefully designed explicit memory~     tasks. Comparison of brain activity during the different test conditions will provide~     information about the brain areas that are involved in mediating specific aspects of~     performance. Both older and younger individuals will be tested in order to understand age~     related changes in the brain activity. In order to examine the interactions between~     participants' differential levels of amyloid burden and their performance on cognitive tasks~     and fMRI neural activation, the investigators also propose PET imaging of older participants.~   "
173269|NCT01297101|"~     The aim of this study is to investigate the efficacy and safety of Tarceva versus combination~     of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2~     NSCLC with EGFR activating mutation in exon 19 or 21.~   "
173270|NCT01297088|"~     The study will be conducted as an open label, single-center, single dose and biodistribution~     study in patients with cancer or inflammation. 56 patients will be selected among the~     patients undergoing the screening examination conducted within 3 weeks before drug~     administration. Single dose of the study drug will be administrated in a dose of 300 MBq to~     these patients. The follow-up period contains the end-of-study telephone interview 5-8 days~     following the treatment. Key measurements are the PET/CT image acquisitions within a time~     frame of about 2 hours after the single injection of BAY86-9596.~   "
173271|NCT01297075|"~     The aim of this project is to motivate and support general practice clinics in implementing~     the visions and recommendations presented in two of the disease specific programmes for~     chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These~     programmes describe evidence based treatment and division of tasks between the~     municipalities, the hospitals and general practice.~      The Facilitator Project is funded by The Danish Ministry of Interior and Health.~   "
173272|NCT01297062|"~     Compare the effect of exenatide (therapeutic and supratherapeutic concentrations),~     moxifloxacin and placebo on the QT interval.~   "
173273|NCT01297049|"~     The overall objective of this pilot study is to develop a cost-effective treatment~     methodology delivered outside of traditional clinical setting, and based on modern technology~     for patients with diabetes type 2 also suffering from obesity. This study will investigate~     the feasibility of web based counselling and situational feedback through mobile supervising.~     The intention is to treat 10-15 patients. All participants will receive standard treatment~     delivered by their general practitioners. In addition the participants will fill in and send~     diaries to the supervisors each evening for 4 weeks reduced to a weekly frequency for the~     next two months period. The diary's schedule will be an evaluation of the day activities~     related to meals and food, medication management as well as the performed physical~     activities. The diary's schedule will also include blood glucose sample, and plans for the~     next day especially regarding physical activity. The participants will be able to view their~     own registrations on a web page. Daily/weekly situational feedback will be given to the~     participants within a cognitive behavioural framework to stimulate self-management. The~     primary outcome will be the HbA1c levels. Secondary outcomes will include evaluation of~     lifestyle outcomes such as physical activity levels and eating behaviour, and skills such as~     self-management of medication. In addition, the interventions effectiveness will examine~     mental health outcomes such as emotional distress and health-related quality of life.~   "
173274|NCT01297036|"~     To compare the relative bioavailability and pharmacokinetic characteristics of a newly~     developed donepezil formulation with a conventional formulation in healthy subjects with a~     single dose, randomized, open-label, 2-sequence -2period crossover study.~   "
173275|NCT01297023|"~     The study was conducted to investigate the effect of vitamin d3 alone and in combination with~     calcium phosphate on bone metabolism and further physiological parameters in healthy~     subjects. It is postulated that calcium phosphate beneficially influences the bone specific~     action of vitamin d3.~   "
173288|NCT01296854|"~     The primary objective of this study is to measure and compare the number of exacerbations~     (moderate or severe) between the two groups of randomized patients with and without thermal~     treatment). An exacerbation is defined by an increase in symptoms which justifies a~     unscheduled medical action: increased daily treatment and / or use of corticosteroids, and /~     or antibiotic therapy. Exacerbations are documented via prescriptions, hospitalisation~     reports or unscheduled visits.~   "
173379|NCT01295645|"~     The goal of this clinical research study is to learn if adding cidofovir to the standard of~     care can improve symptoms of hemorrhagic cystitis caused by the BK virus as compared to~     standard of care alone. The safety of cidofovir will also be studied.~   "
173276|NCT01297010|"~     The majority of pediatric surgery takes place in an outpatient basis. The occurrence of~     postoperative vomiting can lead to a delay in hospital discharge. However, the use of~     postoperative vomiting prophylaxis exposes patients unnecessarily to the drugs side effects~     and also raises the final costs of the surgical procedure. The Objective our study is Compare~     the incidence of postoperative vomiting between children who received dexamethasone,~     dexamethasone plus ondansetron or placebo for anti-emetic prophylaxis during outpatient~     surgery. This is a randomized, double blind, placebo-controlled study to comparing the use of~     dexamethasone, dexamethasone plus ondansetron and placebo for postoperative vomiting~     prophylaxis in children submitted to general anesthesia. Data analysis will be used is~     Fisher's exact test for the categorical variables and the Anova test for numerical variables~     as they presented Gaussian variation. The study used a significance level of 5%.~   "
173277|NCT01296997|"~     The study was conducted to investigate the effect of a calcium phosphate supplementation on~     the secretion of incretins.~   "
173278|NCT01296984|"~     The aim of the project is to evaluate the oncological and functional outcome of the more~     extensive perineal dissection - i.e the extra levator resection - in abdominoperineal~     resections in patients with rectal cancer.~      Hypothesis: Extra levator perineal resection reduces local recurrence three year~     postoperatively compared to traditional abdominoperineal resection and improves QoL 2-4 years~     postoperatively.~   "
173279|NCT01296971|"~     This open-label, non-comparative study will assess the safety and tolerability of~     individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon~     alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype~     1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For~     patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48~     weeks. Patients who had previously received standard or pegylated interferons but were~     non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for~     up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given~     to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week~     follow-up.~   "
173280|NCT01296958|"~     The purpose of this study is to determine whether screening and treatment of tapeworm~     carriers can decrease community transmission of Taenia solium parasitic infection.~   "
173281|NCT01296945|"~     Providing child nutrition information is a major goal of every pediatric well-child visit.~     Unfortunately, due to a wide array of issues, doing this effectively during clinic visits is~     challenging and insufficient. It is because of this that some have looked for innovative ways~     to enhance the delivery of this information. One such way is the use of touch screen computer~     programs containing nutritional information. Several studies have documented the value of~     patients receiving health information in such a manner.~      Nonetheless, the use of this medium has not been well studied in Spanish-speaking care~     providers of young children. The investigators recently conducted a study that evaluated~     user's perception of the usability of such technology, finding that most users thought that~     the touchscreen was easy to use, despite their low computer confidence levels. The~     investigators also evaluated the impact of using nutrition modules on user's nutrition~     knowledge, finding that immediately after use; participant's nutrition knowledge was~     improved. I now propose to evaluate this technology further through a 4 armed randomized~     controlled trial. The goal here is to evaluate the longer term impact of the educational~     modules on nutrition knowledge and the impact, if any, of additional web access to the~     modules, on longer term knowledge. A secondary goal is to better understand nutritional~     habits in this population and perceptions of weight.~   "
173282|NCT01296932|"~     Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two~     prior treatment regimens may be enrolled in this trial. The trial will examine whether~     monotherapy with BI 836826 is safe and tolerable at escalating dose levels.~   "
173283|NCT01296919|"~     Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that~     inflammation of the uncinate process is associated with decreased ventilation and drainage of~     the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses.~   "
173284|NCT01296906|"~     One of the nation's major health priorities, as outlined in Healthy People 2010, is to~     increase the proportion of children aged 19 to 35 months who have received all universally~     recommended vaccines. This study will compare two interventions for increasing immunization~     rates in this age group, one using well-studied primary care practice-based methods and the~     other using innovative technologies to increase immunization rates at the population-level.~     Results of this study will provide data that will be relevant nationally in guiding future~     investment of resources to increase up-to-date rates in young children prior to school entry.~      Hypothesis: Population-based approaches will be more effective than practice-based~     interventions at increasing immunizations among 19-35 month olds.~   "
173285|NCT01296893|"~     Following chemotherapy, some breast cancer survivors report alterations in their ability to~     remember, concentrate, or think, which can have significant emotional, psychological, and~     economic impact on their lives. Survivors have also reported feeling frustrated by the~     response of the medical community, who either may not acknowledge their symptoms or have no~     treatment options to suggest. Exercise may be a promising treatment, as improvements in~     cognitive function with exercise have been demonstrated in older adults and other clinical~     populations.~      The investigators will recruit women who have completed chemotherapy for breast cancer~     (within the past 2 years) and report cognitive changes. Women will be randomly assigned to~     either a 24-week aerobic exercise intervention or delayed exercise control (offered the same~     exercise program following the study). At the start and end of the study the investigators~     will measure: i) performance on four standard neuropsychological tests that measure working~     memory, learning, and problem solving; ii) a questionnaire on cognitive function and its~     impact on quality of life; iii) functional magnetic resonance imaging (fMRI) during two of~     the standard neuropsychological tests which provides information on how the brain is working~     during the tests.~      To knowledge of the investigators this is the first study to examine the effect of an~     exercise intervention on cognitive function in breast cancer survivors. In addition, the use~     of fMRI imaging is a new way to approach this research question, and may be more sensitive to~     change than traditional measures of cognitive function.~   "
173286|NCT01296880|"~     The purpose of this study is to determine the effect of lacosamide on mood and quality of~     life in people with epilepsy.~   "
173290|NCT01296828|"~     Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing~     children.~      Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and~     10 years old, were involved in this research realized in São Paulo, SP, Brazil . It was used~     the MBGR protocol to evaluate the posture, tone and mobility of lips and tongue of mouth~     breathing children.~   "
173291|NCT01296815|"~     Kaposi sarcoma remains the most common malignancy among persons with HIV.~      Lesions localized to the airway may cause bleeding, pain and dyspnea.~      New therapeutic approaches for local disease are needed.~      The purpose of this study is to compare the effectiveness of intralesional bevacizumab +~     HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with~     AIDS.~   "
173292|NCT01296802|"~     Illicit use of the psychostimulant Ecstasy (3,4-methylenedioxymethamphetamine, MDMA) is~     considered a major public health issue. In Switzerland, MDMA and congeners are - after~     cannabis and cocaine - number three in the ranking of the most popular illicit drugs.~     Worldwide, Ecstasy is estimated to be even the second most popular illicit drug, used by~     millions of regular users.~      On the basis of animal data, it is likely that MDMA at high or cumulative doses damages~     serotonin (5-HT) neurons in the human brain. However, because of a multitude of~     methodological problems and a limited number of studies conducted in human subjects, no firm~     conclusions can yet be established whether chronic MDMA exposure produces a long lasting 5-HT~     deficiency syndrome, with consequent neuropsychiatric risks. To further address the putative~     neurotoxicity of MDMA in the human brain, we propose that novel functional assays of~     serotonergic neurotransmission may be useful to clarify this issue. We suggest that a 5-HT~     challenge study using positron emission tomography (PET) in conjunction with the 5-HT~     releaser dexfenfluramine [(+)FEN] may test the functional integrity of the 5-HT system in the~     living human brain.~      Specifically, in a placebo-controlled study, the 5-HT release capacity of serotonergic~     neurons shall be investigated by assessing [18F]-altanserin binding to 5-HT2A receptors~     following (+)FEN challenge in former and continuing MDMA users, and age and sex-matched~     MDMA-naïve controls. (+)FEN is a potent serotonin releaser without relevant affinity for~     5-HT, dopamine (DA) or norepinephrine (NE) receptors, and devoid of acute adverse effects in~     man. This makes (+)FEN an ideal pharmacological probe to explore functional integrity of~     serotonin neurotransmission.~      A second aim of our investigation is to detect possible impairments of cognitive functions~     and to study their relationship to serotonin neurotransmission as indexed by PET. In the~     course of the neuroimaging study, the investigators therefore also measure cognitive (e.g.~     attention, visual and working memory, learning, executive function) and affective functions~     (e.g. anxiety, impulsivity), suspected to be altered due to chronic MDMA use. Using~     correlational analyses, the investigators aim to determine if circumscribed regions of~     altered 5-HT function are associated with specific impairments in cognitive and/or~     behavioural parameters.~      We hypothesize that (+)FEN-evoked 5-HT release will discernibly alter availability of 5-HT2A~     receptors to [18F]-altanserin, with a pattern revealing the spatially heterogeneous~     vulnerability of 5-HT innervations to MDMA. The investigators predict that [18F]-altanserin~     volume of distribution (DV) will decline following (+)FEN challenge to a lesser extent in~     current MDMA users compared to MDMA-naïve control subjects. On the basis of animal data and~     recent neuroimaging studies in humans, the investigators hypothesize that functional recovery~     in former MDMA users will be manifest by a normalization or overshoot of the 5-HT release~     capacity.~      Our methodology will allow us to quantitatively assess serotonergic functions in the living~     human brain. The novel combination of (+)FEN-induced release of 5-HT from intracellular~     storage vesicles and subsequent PET assessment of competitively altered [18F]-altanserin~     binding at postsynaptic 5-HT2A receptors will provide a more direct biological marker of in~     vivo serotonin function than has been hitherto available. By applying this new~     pharmacological challenge/PET neuroimaging approach to groups of current and former users of~     MDMA, the investigators shall be able to gain important new insight in the debated functional~     consequences of MDMA use, especially concerning the controversy about the reversibility of~     5-HT changes following cessation of MDMA use. Successful completion of this project should~     have useful implications for public education and harm reduction with respect to MDMA use,~     and may also facilitate the development of possible treatment options for chronic MDMA users.~   "
173293|NCT01296789|"~     The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of~     septic shock patients. For hemodynamic stabilization the SSC recommends distinct treatment~     goals. The study hypothesis is that a tissue perfusion guided protocol could reduce the~     duration on vasopressor treatment compared to a conventional protocol.~   "
173294|NCT01296776|"~     Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone via~     its acute and longitudinal effects on muscle mass and strength, the corresponding impact on~     bone density and falls in older adults has not been assessed yet. The investigators~     hypothesize that WB-EMS significantly affects bone parameters as assessed by DXA, and~     significantly reduce fall rate and ratio in a cohort of frail elderly women.~   "
173295|NCT01296763|"~     Patients whose pancreatic cancers have defects in the BRCA/Fanconi DNA repair pathway or~     other defects in homologous repair will have cancers that respond to olaparib when given in~     combination with the DNA damaging agents, irinotecan, cisplatin, mitomycin C (ICM).~   "
173296|NCT01296750|"~     A knee dislocation is an unusual and extremely serious injury and is defined as complete~     displacement of the tibia with respect to the femur, usually with disruption of 3 or more of~     the stabilizing ligaments. When the knee dislocates, there is often significant damage to the~     soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not~     surprisingly, this injury is a profoundly debilitating, life-altering event, with the~     potential to necessitate career change in athletes and laborers alike. Current evidence~     indicates that operative management for these injuries is more effective at returning~     patients to pre-morbid range of motion (ROM) and activity than conservative management. Post~     operative rehabilitation programs for these patients must balance the need for stability of~     their surgical repair and knee ROM and functionality. Experimental data suggests that~     post-operative immobilization offers greater protection of the surgical reconstruction,~     whereas immediate, aggressive physiotherapy may be more effective at preventing~     arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial~     comparing early physiotherapy (day one post op) versus immobilization for three weeks then~     initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects~     except for progam initiation.~   "
173297|NCT01296737|"~     The purpose of this study is to validate the use of DSPECT camera for the performance of~     quantitative spect ventricular function imaging by comparison to a validated procedure~     performed on standard nuclear cameras.~   "
173298|NCT01296724|"~     Abdominal Compartment Syndrome (ASC) is defined by an Intra Abdominal Hypertension (IAH)~     associated with a new organ failure. The occurrence of this syndrome is not well known in~     infants. Preterm birth is frequently associated with gastrointestinal complications,~     particularly Necrotizing Enterocolitis. In this pathology it is likely that the intra~     abdominal pressure (IAP) increases and can participate in the occurrence of organ failures.~     Newborn, in particular with digestive malformation as diaphragmatic hernias, gastroschisis,~     could themselves be suffering from this syndrome. It would be interesting to make early~     diagnosis in order to optimize the management of these children. This requires reliable~     measurements methods and standards. Intravesical Pressure (IVP) is the most reliable~     validated indirect method to measure intra-abdominal pressure. In order to measure the IVP,~     the bladder must contain a minimum of liquid. However, using inappropriate volumes could give~     erroneous IAP readings. The optimal amount of saline to inject in older children, determined~     from pressure-volume curves study is 1 ml/kg. In preterm and term infants, this volume appear~     extremely low (e.g. 0 8cc if taking a child to 800 g). The question that arises is whether~     this quantity is sufficient to obtain reliable and reproducible measurements of IVP in~     preterm and term.~   "
173299|NCT01296711|"~     The purpose of this study is to evaluate the long term safety and tolerability of CDP6038~     treatment in adult subjects with active rheumatoid arthritis (RA) who completed RA0056.~   "
173300|NCT01296698|"~     This study is to see if a new nicotine replacement therapy safely helps people to quit~     smoking if it is used the way it would be if it were sold at the pharmacy and used at home.~     Approximately 1500 subjects will be enrolled into the study. The study will require~     participants to use the treatment for 12 weeks and there will be a 14-week follow-up period.~     The study will be conducted in approximately 20 pharmacies across the United States.~      At the first visit to the pharmacy, participants will be asked some questions to see if they~     are eligible to participate. Participants will be asked to sign a consent form if they agree~     to participate. Participants will answer some more questions, and blow into a machine to~     measure their carbon monoxide (CO) levels to make sure they qualify for the trial.~     Participants will be asked to go to a nearby dentist who will look at their mouths.~     Participants will go back to the pharmacy and if they qualify, they will be given a supply of~     their assigned treatment. They will have an equal chance of receiving a treatment that has a~     drug in it or one that has no drug in it. They will be given a diary to keep track of how~     much of the treatment they use.~      Subjects will go to the pharmacy four more times to hand in their diaries and blow into a~     machine that will measure their CO levels. At the last visit, subjects will have their mouths~     examined by a dentist again to have their mouth checked.~      Subjects will receive four telephone calls during the study where they will be asked some~     questions.~      After the 12 week treatment period, subjects will receive two to three more telephone calls,~     where they will be asked to answer some questions. Participants may be asked to come back to~     the pharmacy two more times to blow into the carbon monoxide machine again.~   "
173410|NCT01295242|"~     The purpose of this study is to determine rates of oral and genital human papillomavirus~     (HPV) infections, and look at risk factors for HPV infection in healthy mid-adult women.~   "
173301|NCT01296685|"~     The goal of the study is the evaluation of the air handling of a new type of oxygenator~     versus the standard model. The new type has an integrated arterial filter. The standard model~     has a non integrated arterial line filter. If the air handling is as effective/ better than~     in the standard model this can lead to reduction of cardiopulmonary bypass circuits with~     their initiation of systemic inflammatory response and improve cardiopulmonary bypass safety.~   "
173302|NCT01296672|"~     The investigators will propose a novel method to improve prostate cancer screening with PSA,~     using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia~     (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will~     also examine three additional promising tests that may further improve diagnosis of prostate~     cancer.~   "
173303|NCT01296659|"~     Ridaforolimus has been tested in almost 2 dozen studies; however, it has not previously been~     tested in combination with the standard of care chemotherapy for sarcoma as this study will.~     We will be looking to see if Ridaforolimus given with SOC chemo (AIM or TG) is well tolerated~     and to determine a Phase 2 dose.~   "
173304|NCT01296646|"~     Purpose: The proposed 2-year investigation will be the first double-blind, placebo-controlled~     trial examining the hedonic response to sweet taste (HRST) as a phenotypic predictor of~     naltrexone (NTX) response in alcohol dependence. HRST yields two primary phenotypes—Sweet~     Likers (SL) and Sweet Dislikers (SDL). Based on preliminary findings, HRST will be examined~     in conjunction with craving for alcohol to assess whether the two factors together provide a~     more robust predictor of NTX response. The identification of methods to predict naltrexone~     response in alcohol dependence is an important goal for alcohol treatment research. Currently~     naltrexone is not being used nearly as much as it should be, in part because clinicians do~     not believe it is very effective. The development of tools that would identify which patients~     are more likely to have a robust response to naltrexone should lead to increased use of the~     medication. This could help many patients who are not now having the opportunity of trying~     naltrexone.~      There are two principal Specific Aims for the study:~      Specific Aim 1. To test the hypothesis that a combination of SL/SDL status and initial~     alcohol craving will predict % abstinent days (%ABST) during treatment with naltrexone.~      Specific Aim 2. To test whether a combination of SL/SDL status and initial alcohol craving~     predict % heavy drinking days (%HDD) during treatment with naltrexone.~   "
173305|NCT01296633|"~     The broad goal of this project is to improve knowledge of and adherence to medication~     regimens and health outcomes among adults with type 2 diabetes or other metabolic disorders.~     These patients have complex self-care needs, but limited literacy and cognitive skills to~     meet these needs. Medication error is widespread and costly, and often associated with~     inadequate patient knowledge about medication, especially among chronically ill adults with~     limited health literacy. Inadequate knowledge is often traced to limited communication with~     providers, in part because of barriers such as limited patient contact time and communication~     training, and lack of system-level support for consistent use of patient-centered strategies.~     There is a need to leverage information technology (IT) to provide system-based support for~     patient-centered communication. The investigators will evaluate an Electronic Medical Record~     (EMR)-based tool (the Medtable) to support provider/patient communication and improve~     medication knowledge, adherence, and health outcomes among chronically ill adults with~     complex medication regimens. A paper-based Medtable has been found to help older adults~     create accurate medication schedules in a simulated patient/provider communication task~     (Morrow et al., 2008). Benefits for patients should be enhanced if the Medtable is integrated~     with an EMR, giving providers ready access to relevant background information and current~     medication lists that patients can update, so providers can generate and tailor the Medtable~     for a diverse set of patients. This system provides an integrated approach to patient~     education about medications, from prescribing to counseling during office visits. As a~     result, patients would not only understand how to take their medications, but develop~     concrete plans for doing so. Specific aims of the project are: 1) Refine the Medtable~     prototype for use in an EMR environment. This includes developing protocols for generating~     patient-specific Medtables and educating providers to use them in medical encounters. 2)~     Evaluate the Medtable's impact on patient care processes and outcomes. The investigators will~     test the following hypothesis about communication processes: H1) Patients in the intervention~     condition will be more satisfied with communication about medication than patients in the~     usual care condition. The investigators will also test the following hypotheses about patient~     outcomes: Compared to usual care patients, patients receiving the Medtable intervention will:~     H2) know more about their medications; H3) adhere more accurately to their medication~     regimens; H4) more likely have blood glucose (glycosylated hemoglobin, HbA1c) levels in the~     target range. Aim 1 will be accomplished by interviewing physicians and their patients as the~     system is refined to ensure ease of using the system, and by collecting preliminary evidence~     that the Medtable improves patient/provider communication. After establishing initial~     feasibility and ensuring provider acceptance of the system, Aim 2 is addressed by a~     randomized trial at the general internal medicine clinics in Chicago and Peoria (IL),~     comparing patients who use the Medtable with their providers to those receiving usual care.~   "
173306|NCT01296620|"~     Post-operative administration of ulimorelin is expected to reduce time to recovery of~     Gastrointestinal (GI) function in patients who have undergone partial large bowel resection~   "
173307|NCT01296607|"~     Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem~     with a poor prognosis and the search for novel treatments remains an important area of~     research.~      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There~     has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in~     heart failure.~      In this study, we will examine the pharmacokinetics and pharmacodynamics (in particular the~     onset-offset of action and reproducibility of vasodilator effects) of Urocortins 2 & 3 on~     forearm arterial blood flow healthy volunteers.~      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we~     will be able to focus on the local effects of urocortins on arterial blood flow in forearm~     vessels, without affecting this system in the body as a whole.~   "
173308|NCT01296594|"~     Poor adherence to antihypertensive medications is associated with morbidity, and data suggest~     that substance abuse may contribute to poor adherence. Contingency management (CM), an~     intervention highly efficacious for improving outcomes of substance abusers, shows promise in~     improving medication adherence in a handful of small trials. CM involves providing tangible~     reinforcement each time the behavior (medication ingestion) is exhibited. Thus far, studies~     evaluating CM for increasing medication adherence have utilized MEMS caps, but reinforcement~     of adherence via MEMS caps is done relatively infrequently and with delay, hindering its~     efficacy. A widely utilized technology that may be more appropriate for reinforcing~     medication adherence is cell phones, which can record the process of pill ingestion through~     video functions. As regular monitoring and feedback is important in the efficacy of CM,~     patients can be provided with daily messages regarding adherence and CM earnings. In this~     pilot study, we propose to randomize 40 hypertensive substance abusing patients with~     suboptimal adherence to antihypertensive medications to one of two 12-week treatment~     conditions: (1) usual care, or (2) usual care with cell phone monitoring and CM. In the CM~     condition, patients will carry a cell phone and record and send in time- and date-stamped~     self videos of medication ingestion. These patients will receive congratulatory messages or~     reminders about adherence, and they will earn vouchers each time medication ingestion occurs~     at the appropriate time, along with bonuses for sustained adherence. We hypothesize that the~     CM condition will improve self report and pill count measurements of medication adherence and~     that it will result in decreased blood pressure. Results from this study may have widespread~     implications for the use of cell phones as a novel technology to improve medication~     adherence.~   "
173309|NCT01296581|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a~     single agent.~   "
173310|NCT01296568|"~     This is an open-label study being conducted to determine the metabolism and physiological~     disposition of radiolabeled LY2603618 after a single dose in patients with advanced and/or~     metastatic solid tumors.~      After a minimum 7-day washout period following the [14C]LY2603618 dose, patients will be~     allowed to continue to receive continued access to LY2603618 in combination with pemetrexed~     or gemcitabine as outpatients.~   "
173311|NCT01296555|"~     This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and~     pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During~     Stage 1, GDC-0032 will be administered every day orally and at escalating doses in~     participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will~     be administered alone or as combination therapy within indication-specific cohorts. In Phase~     II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be~     evaluated in post-menopausal female participants with locally advanced or metastatic human~     epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.~   "
173312|NCT01296542|"~     To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the~     conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3~     days of treatment.~   "
173322|NCT01296412|"~     This study is being done to compare the effectiveness and safety of two treatment paradigms~     (oral sitagliptin with or without glimepiride versus liraglutide with or without increased~     dosing) for the treatment of participants with Type 2 Diabetes that is not adequately~     controlled with metformin alone. The primary hypothesis postulated that the mean change from~     baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment~     is non-inferior to that of participants treated with a liraglutide-based~      treatment.~   "
173313|NCT01296529|"~     Liver-related death is the leading cause of mortality in HIV-infected individuals with CD4+~     cell counts over 200, and hepatitis C virus (HCV) infection is the greatest risk for~     liver-related mortality in HIV-positive patients. Compared to HCV monoinfected individuals,~     patients with HIV and HCV coinfection experience accelerated progression of liver fibrosis,~     which can lead to higher incidence of cirrhosis, end stage liver disease (ESLD), and death.~     Changes in CD8+ T-cell activation, inflammatory cytokines, and serum markers of tissue injury~     may offer an immunologic platform to determine factors associated with progressive liver~     fibrosis in coinfected patients. In this cross-sectional study we will evaluate whether HIV~     and HCV coinfection patients with well-controlled HIV infection who have an undetectable~     viral load exhibit abnormal levels of inflammation and immune activation, potentially~     contributing to advanced liver fibrosis. Comparative groups include coinfected patients~     successfully treated for hepatitis C, or who have absence of hepatitis C viremia through~     spontaneous clearance, hepatitis C monoinfected patients, and HIV-positive patients with~     well-controlled HIV infection without hepatitis C. Liver fibrosis will be measured by~     non-invasive methods.~      The primary objectives of this study are:~        1. To determine if there are differences in markers of inflammation and immune activation~          in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection.~        2. To assess the stage of liver fibrosis using non-invasive methods in subsets of patients~          with hepatitis C and HIV and hepatitis C coinfection and compare the degree of liver~          fibrosis with levels of inflammation and immune activation.~   "
173314|NCT01296516|"~     The overall objective of this pilot project is to test in 50 women with a history of~     gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month~     intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year~     after delivery.~   "
173315|NCT01296503|"~     This multicenter, prospective, randomized trial was designed to evaluate the role of~     thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma~     patients after a single autologous stem cell transplantation.~   "
173316|NCT01296490|"~     Physical exercise has many benefits, although it might also have negative impact on the body,~     which changes in accordance with training level, length of workout, age of subject and their~     fitness level. These outcomes are governed by complex biological processes, from which~     Reactive Oxygen Substances (ROS) are considered the most prominent ones during exercise~     activity. These substances harm muscle activity, and might cause other health related damage~     by influencing other pathways that engage with free radicals. Excess of ROS, is expressed as~     Oxidative Stress (OS), pathogenic process activation and aging. With this in mind, it is~     important to remember that ROS are essential to the investigators bodies as well, especially~     in gene regulation. Thus they influence proteins that are important for proper muscle~     function and the immune system.~      Physical exercise induces changes in low molecular weight antioxidants, and in antioxidant~     enzymes. According to results that were published in the literature, no universal conclusion~     can be made regarding physical exercise effect on antioxidants activity. These contradictions~     might be attributed to the difference between the methods that were used, and their quality.~      Paradoxically, physical exercise has the same effect on ROS inducement in skeletal muscle~     fibers as does not using the muscles for a long period of time (especially as a result of~     handicap). It is well known that physical exercise effect oxidative stress and antioxidant.~     Due to the doubts that rise from the literature, the investigators think that it is important~     to test physical fitness effect on oxidative stress biological markers, using various high~     quality methods, on the same population.~      The investigators will test healthy men, 20-35 years of age, none smokers with 6-24% fat, who~     do not take vitamins or supplements. The men will run on a treadmill for 10 minutes to~     exhaustion, and blood will be taken before the test, 5 minutes after the test, and an hour~     after the test (checking recovery).~   "
173317|NCT01296477|"~     There is a mounting body of evidence suggesting that there is a large disparity between the~     development and the actual implementation of guideline-driven asthma care in primary and~     specialty care practices. To address this disparity, the American Academy of Allergy, Asthma~     & Immunology (AAAAI) developed a unique, comprehensive and easy-to-use Web-based tool for~     clinicians who treat asthma patients called Asthma Specialist Tool to Help Manage Asthma and~     Improve Quality (Asthma-IQ). This study will examine whether the use of the Asthma IQ~     primary care tool will improve asthma care and asthma outcomes using a randomized trial of~     the Asthma IQ system versus usual asthma care in the primary care setting over 1 year. At the~     end of 1 year, all patients will be managed using the Asthma-IQ tool for an additional year~     to determine if the patients managed by usual care in the first year improve when managed in~     conjunction with Asthma-IQ. The primary endpoint to determine if the use of the Asthma IQ~     tool will improve asthma patient outcomes is quarterly assessments of Asthma Control Test~     (ACT) scores via automated / electronic patient survey. The secondary endpoint is asthma~     exacerbations and there are a number of exploratory endpoints to further define the clinical~     utility of the primary care version of Asthma-IQ. This study will involve recruiting~     approximately 20 family medicine offices with approximately 20 patients each, to conduct this~     randomized, multiple time point intervention trial. The necessary total recruited patient~     sample size is 200 per group. The results of this study will help determine the utility of~     Web-based tools to help manage chronic diseases such as asthma.~   "
173318|NCT01296464|"~     The primary objective is to assess the effect of a single dose of two experimental~     levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment~     regimen in Parkinson's disease (PD) patients with end-of-dose motor fluctuations in terms of~     duration of motor response after the first morning dose of levodopa. The secondary objective~     is to evaluate the safety of the L/C/E treatment regimens in patients with PD.~   "
173319|NCT01296451|"~     The study is aimed at assessing the safety of AdCh3NSmut and the new candidate vaccine~     MVA-NSmut when administered sequentially, or alone, to healthy volunteers and patients with~     hepatitis C virus infection The study also aims at assessing the cellular immune response~     generated by AdCh3NSmut and MVA-NSmut administered as mentioned above.~   "
173320|NCT01296438|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic~     (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin~     aspart.~   "
173321|NCT01296425|"~     This is a National, Multicentre, Observational Registry to study adherence and long term~     outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth~     hormone treatment from hospitals in Austria and to assess the level of adherence of subjects~     receiving SAIZEN® via Easypod™.~   "
173336|NCT01296230|"~     The purpose of this study is to determine if the pre-operative levels of sex-hormones can be~     used to identify the varicocele patients who can expect improvements in their semen~     parameters following varicocelectomy.~   "
173337|NCT01296217|"~     In this study the investigators want to determine if the detection of lymph node is~     applicable in prostatectomy by laparoscopy.~   "
173323|NCT01296399|"~     Intra-coronary stents deployment reduces the rate of angiographic restenosis as compared to~     Balloon angioplasty. in-stent restenosis, usually defined as ≥50 percent diameter stenosis~     within previously deployed stent, is most often becoming clinically evident within the first~     6 to 12 months after the stent was deployed. Several risk factors are predictors for the~     development of in-stent restenosis. These can be generally calcified as either clinical,~     angiographic or procedural related factors. However it is difficult to estimate to what~     extent In stent re-stenosis is influenced by these various components.~      Drug eluting stent, as compared to bare metal stents, markedly reduced the incidence of~     angiographic in-stent restenosis. However this benefit must be weighed against a suggested~     increased risk of late and very late stent thrombosis, a catastrophic event often leading to~     myocardial infarction and death. Often in patients with existing risk factors for in-stent~     restenosis, drug eluting stents will be deployed even in cases where patency of a previously~     deployed bare metal stent have been demonstrated.~      Therefore the researchers sought to investigate whether in patients with previously deployed~     bare metal stent and no evidence of in-stent re-stenosis there will be a significant~     difference in the rates of in-stent between drug eluting stents and bare metal stents~     deployed within de-novo stenotic lesions.~   "
173324|NCT01296386|"~     An open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, A~     new vaccine against Clostridium Difficile (C. difficile), In healthy subjects~   "
173325|NCT01296373|"~     RESTORE study:Thailand is a prospective observational study of HIV-1-infected patients who~     are either treatment naïve or who have been off anti-retroviral therapy for a ≥12 months, who~     have a CD4+ T cell count less than or equal to 350 cells/µL and who have been deemed by their~     treating physician that commencement of combination antiretroviral therapy (cART), which is~     expected to reduce plasma HIV RNA by ≥1log10 copies/mL, is necessary.~      The primary intent of this protocol is to prospectively establish a cohort of patients from~     whom clinical data and peripheral blood samples (serum, plasma and peripheral blood~     mononuclear cells) can be stored for substudies examining reconstitution of the immune system~     and its relationship to disease outcomes.~   "
173326|NCT01296360|"~     This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years~     and 7 months who have been vaccinated with IXIARO in study IC51-323.~   "
173327|NCT01296347|"~     This study will test the null hypothesis that low-dose ketamine given peri-operatively will~     have no effect on the development of chronic post-surgical pain, in patients undergoing~     thoracotomy or video assisted thoracic surgery (VATS) procedures~      A double-blind, randomised placebo-controlled trial will be used to test the null hypothesis.~     Potential participants due to undergo either thoracotomy or video assisted thoracic surgery~     (VATS) will be identified by the collaborating thoracic surgeons in the out-patient~     department. Patients will be sent information about the study by post, prior to admission for~     surgery. If they are willing to participate, written consent will be sought on the ward~     preoperatively, where they will complete baseline measures of pain.~      Patients will be randomised to receive an intravenous infusion of placebo (saline) or~     ketamine running at 0.1mg/kg/hour, starting 10 minutes prior to the surgical incision and~     continuing for the first three postoperative days (96 hours in total). Prior to starting the~     infusion a loading dose of ketamine (0.1 mg per kg) will be administered.~   "
173328|NCT01296334|"~     Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain~     from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the~     present study we investigate primary and secondary hyperalgesia in healthy volunteers~     following an experimental first degree burn injury.~      The objectives are:~        -  to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and~          buprenorphine).~        -  to investigate if these effects are related to the volunteers individual pain~          sensitivity~   "
173329|NCT01296321|"~     The purpose of this study is to determine whether tailored internet-administrated CBT is a~     feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive~     symptoms.~   "
173330|NCT01296308|"~     Despite the long tradition of complementary and alternative medicine (CAM) therapies there~     are hardly any interventional trials on type 2 diabetes mellitus. Hence this pilot study aims~     to investigate the influence of a two weeks integrative inpatient therapy on the quality of~     life in 50 patients suffering from diabetic neuropathy. Integrative treatment includes~     aspects of conventional and traditional European and Chinese medicine, mind-body medicine,~     physical therapy and lifestyle modification (nutrition advices, stress management and~     exercise training). The observational design intends four measurement points: tree months~     before (T0), directly before (T1), directly after treatment (T2) and three months follow-up~     (T3). The subjective evaluation of the neuropathy-related quality of life was combined with~     neurophysiologic instruments (QST), to measure neuropathic symptoms. Also pain intensity,~     locus of control, interpretation of illness, coping style, anxiety/depression, life~     satisfaction and several biomarkers (HbA1c, ABI, WHR and BMI) are measured. In addition a~     qualitative interview should give a view to patient perspective of therapy process.~   "
173331|NCT01296295|"~     The purpose of this study is to evaluate the effectiveness of regular reporting of~     spirometric results combined with smoking cessation advice on smoking quit rate in adult~     smokers in primary care.~      Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with~     smoking cessation advice will increase smoking quit rate.~      Expected outcome: increase of smoking cessation rate .~   "
173332|NCT01296282|"~     To compare two methods of chest impedance: the Medtronics Optivol Measurement via CRT~     pacemakers for patients with heart failure and external non-invasive measurement~   "
173333|NCT01296269|"~     The purpose of this study is to investigate the role of a one-time intranasal administration~     of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation and~     altruism in a healthy population of student controls.~   "
173334|NCT01296256|"~     The purpose of this study is to determine whether Bendamustine in combination with Etoposide,~     Cytarabine and Melphalan (BeEAM) are effective as conditioning followed by ASCT in patients~     with aggressive lymphoma.~   "
173335|NCT01296243|"~     Given the activity of docetaxel in patients with progressive, metastatic castration-resistant~     prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an~     orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.~   "
173338|NCT01296204|"~     The first step of this protocol called step pre-treatment study the biodistribution and~     pharmacokinetics of a tracer dose of radiolabeled antibody. The second step called step~     therapy study the toxicity and antitumor effects of antibody B-B4 coupled with increasing~     doses of iodine 131. At least 17 patients will be included for an estimated duration of 2~     years to determine the maximum tolerated dose and dose limiting toxicity. The immediate side~     effects, medium and long terms will be analyzed. After determining the toxic dose limit,~     patients will be treated at the maximum tolerated dose, for a total of 15 patients at this~     level, which will measure the objective tumor response to treatment. These patients will be~     followed for 1 year after injection therapy.~      ÉcouterLire phonétiquement~   "
173339|NCT01296191|"~     The purpose of this study is to compare drug concentrations in aqueous humor following ocular~     instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.~   "
173340|NCT01296178|"~     Advances in the biological characterization of AML can now make a proper estimate of the risk~     of recurrence and likelihood of survival of different groups of patients according to the~     expression of different disease parameters. Karyotype, the molecular alterations affecting~     genes FLT3, NPM1 and CEBPA, minimal residual disease by flow cytometry and response to first~     induction cycle are variables that must be taken into consideration when planning the~     treatment of first line from a patient with AML.~      This breakthrough in the field of biology has not resulted yet in the development of new~     drugs really effective in the treatment of AML. Therefore, the core of the treatment continue~     to rely on the use of traditional chemotherapy combined or not with allogeneic hematopoietic~     stem cell. Both treatments differ in their antileukemic efficacy, higher in aloTPH, as well~     as their toxicity and procedure-related mortality, increased also in the aloTPH. These~     aspects should be added that most candidates aloTPH patients lack an HLA identical sibling~     donor forcing the search for alternative sources and hematopoietic stem cell donors. These~     transplants alternative, but are not committed to their antileukemic efficacy, it does have~     implied a greater toxicity. Therefore, the ultimate effectiveness of these procedures depends~     largely on the proper selection of candidates for the same.~      While there is broad agreement in terms of induction chemotherapy using a combination of~     cytarabine with anthracycline, the choice of chemotherapy regimen is controversial~     postremisión today. In the poor prognosis of itself involve the LMA, patients classified as~     favorable group are acceptable disease-free survival with consolidation schemes involving~     high-dose cytarabine. For other patients appear to be inappropriate to combine cytarabine~     with an anthracycline, at least one cycle of consolidation, and raise the option of~     allogeneic different depending on prognostic markers~   "
173341|NCT01296165|"~     It is not clear why multi-resistant E. coli (also known as ESBL-producing) have recently~     became such important causes of infections in patients living and residing in the community.~     A risk factor analysis study performed during 2004 and 2005 in Calgary had shown that the~     consumption of the same types of food or well water sources were not significant risk factors~     for community-associated infections due to these E. coli. However, a significant and~     unexpected risk factor among these Calgary patients was recent visits to certain high-risk~     areas such as the Indian subcontinent (India, Pakistan), Africa and the Middle East.~     Therefore it is possible that international travel to certain high-risk destinations might~     play, in part, a role in the spread of multi-resistant E. coli across different continents.~     This would happen via the acquisition of these bacteria in the rectums of returning travelers~     and the same organism would later cause an infection. However, the evidence that the spread~     and infections due to ESBL-producing E. coli are associated with international travel is~     circumstantial at best and the investigators would like to prove that this is indeed true.~      The basic idea of the study is to culture the stool of travelers for ESBL-producing E. coli~     before they leave for India, within seven days after their return to Canada and again after~     six months. The investigators can then establish which travelers are rectally colonized when~     visiting India and if these bacteria are still present six months after their return. A~     detailed questionnaire regarding the traveler's itinerary and behaviours in India will be~     completed on their return to Canada. The investigators will then compare the itinerary and~     behaviours of colonized travelers with those of non-colonized travelers and identify certain~     high-risk behaviours and places for acquiring ESBL-producing E. coli in India. The~     investigators will also determine if colonized travelers will later develop infections with~     the same ESBL-producing E. coli they acquired while visiting India.~   "
173342|NCT01296152|"~     This study was done to look at the level of Depo-Provera, an injectable birth control, in the~     blood to see whether it is affected by the anti-HIV drug Kaletra (lopinavir/ritonavir~     [LPV/r]). It is not known whether taking Depo-Provera together with Kaletra changes the~     amount of Kaletra in blood. Therefore, this study also looked at the levels of HIV and~     Kaletra before and after receiving a shot of Depo-Provera. This study evaluated the safety of~     Depo-Provera and Kaletra when they are used together. In addition to what is stated above,~     this study also explored any effect of Depo-Provera on the immune system.~   "
173343|NCT01296139|"~     Background:~      - Ferumoxytol is an approved iron replacement therapy agent that has some potential for use~     as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes~     that have been affected by cancer. Ferumoxytol is taken up by normal lymph nodes, but~     excluded from cancerous lymph node tissue. Because Ferumoxytol has not yet been approved for~     use as an imaging agent, researchers are interested in testing its effectiveness as a~     contrast agent for studies of normal lymph tissue and cancer tissue in lymph nodes of~     individuals with prostate cancer.~      Objectives:~      - To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals~     who are scheduled to have prostate removal surgery to treat prostate cancer.~      Eligibility:~      - Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled~     to have surgery to remove the prostate and surrounding lymph nodes.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and tumor imaging studies.~        -  Participants will have a magnetic resonance imaging (MRI) scan to provide baseline~          images for the study.~        -  Participants will receive an injection of Ferumoxytol and will return for another MRI~          scan on the following day (around 24 hours later).~        -  Some participants may have a third MRI scan 48 hours after the initial injection of~          Ferumoxytol. This third MRI scan is optional and not required by the study.~        -  Although the scanning and followup portion of the study will last only a few days,~          participants will be considered to be enrolled on the study until after the prostate~          removal surgery.~   "
173355|NCT01295957|"~     The effectiveness of reminiscence for dementia has been claimed as an effective tool, but~     scientific validation and systematic assessment of this method is needed. Materials and~     Methods: A randomized controlled trial (RCT) was conducted to search whether a reminiscence~     program is associated with improvement of quality of life of demented long term care~     residents. The trial had three arms: interventional, comparison and control. The reminiscence~     program was modeled within a life-story approach, while comparison group received informal~     counseling to control for changes in quality of life resulting from social contacts. The~     Social Engagement Scale (SES) and Self-rated Quality of Life Index (SRQoL) were the outcome~     measures. The results were examined at baseline (T0), twelve weeks (T1), and 6 months (T2)~     after intervention. The sample had 135 subjects [intervention group (N=45), comparison group~     (N=45) and control group (N=45)].~   "
173356|NCT01295944|"~     The goal of this clinical research study is to learn if the combination of bevacizumab and~     carboplatin can help to control recurrent pendymoma. The safety of this drug combination will~     also be studied....~   "
173344|NCT01296126|"~     Background:~      - Studies have shown that some people develop post-traumatic stress disorder (PTSD) after~     being exposed to the trauma of military combat. They may have repeated thoughts, images, and~     dreams of the trauma; feel detached from others; have difficulty sleeping and concentrating;~     or be easily startled. Some studies have also shown that after having a blow or blast to the~     head, some people may develop post-concussive syndrome (PCS), which may include symptoms such~     as headaches, difficulty concentrating, and feeling moody or irritable. Researchers are~     interested in using magnetic resonance imaging (MRI) to study combat veterans from Operation~     Iraqi Freedom or Operation Enduring Freedom in order to evaluate possible changes in the~     brain that may be attributed to PTSD or PCS.~      Objectives:~      - To evaluate changes in brain function in recent combat veterans that may be related to~     post-traumatic stress disorder or post-concussive syndrome.~      Eligibility:~      - Combat veterans of Operation Iraqi Freedom/Operation Enduring Freedom who are enrolled in~     Walter Reed Army Medical Center protocol 351030, have returned within the last 6 weeks from a~     deployment in Iraq or Afghanistan that lasted at least 3 months, and are able to have~     magnetic resonance imaging scans.~      Design:~        -  This study involves between 1 and 4 outpatient visits to the NIH Clinical Center over~          the course of 1 year. The second, third, and fourth visits will occur 3, 6, and 12~          months after the first visit.~        -  At the first visit, participants will have a baseline MRI scan, followed by a functional~          MRI (fMRI) scan to see what parts of the brain are used while performing simple tasks~          and responding to images. Participants will complete questionnaires after the scan to~          report on their experiences during the MRI scan.~        -  For the remaining three study visits, participants will have further MRI and fMRI scans~          and will complete additional questionnaires. Participation is complete after the~          12-month study visit, or following a diagnosis of PTSD, major depression, or PCS at any~          time during the study.~        -  No treatment will be provided as part of this protocol.~   "
173345|NCT01296113|"~     This is a phase II, multicenter, non-randomized, open-label study evaluating the combination~     of pemetrexed plus carboplatin in HIV-positive patients with lung cancer.~   "
173346|NCT01296100|"~     The main aim of this study is to investigate to what extent it is possible to reach normal~     glucose metabolism and optimal cardiovascular disease (CVD) risk factor levels with early~     lifestyle interventions in people at high risk of type 2 diabetes compared with those who~     receive standard therapy (usual care) only.~      The project will show the effect of these interventions for the first time in people of low~     socio-economic levels living in a Caribbean environment.~   "
173347|NCT01296087|"~     This study is designed to determine whether TC-6987 improves respiratory function in subjects~     with asthma by reducing airway hyper-responsiveness and inflammation.~   "
173348|NCT01296074|"~     To observe the effect of glucocorticoid on the dynamic changes of monocyte subsets in the~     peripheral blood of valve disease patients undergoing cardiopulmonary bypass perioperatively.~   "
173349|NCT01296061|"~     Primary Hypotheses:~        1. Among patients who retain the failed kidney transplant, those who continue~          immunosuppressant medication will have more deaths than patients who discontinue these~          drugs~        2. Among patients who retain the failed kidney transplant, those who continue~          immunosuppressant medication will have more hospitalizations for sepsis than patients~          who discontinue these drugs~        3. Among patients who retain the failed kidney transplant, those who continue~          immunosuppressant medication will have fewer rejection events than patients who~          discontinue these drugs~      Secondary Hypotheses:~        1. Patients who undergo elective nephrectomy (to remove the failed kidney transplant) will~          have fewer deaths than those who retain the failed kidney transplant~        2. Patients who undergo elective nephrectomy (to remove the failed kidney transplant) will~          have fewer hospitalizations for sepsis than those who retain the failed kidney~          transplant~        3. Among patients who retain the failed kidney transplant, those who continue~          immunosuppressant medication will have lower levels of allosensitization (anti-HLA~          antibodies) than those who discontinue these drugs~        4. Patients who undergo elective nephrectomy will have higher levels of allosensitization~          (anti-HLA antibodies) than patients who retain the failed kidney transplant~   "
173350|NCT01296048|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the functions and efficiency of devices.~        2. Test methods and procedures: Comparison Test.~        3. DUT: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.~        4. Comparison device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device).~        5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Efficiencies of Transtek devices and predicate device are in the same level.~   "
173351|NCT01296035|"~     This is a study to find out if the study drug, panitumumab, when given with gemcitabine works~     in treating ovarian cancer and to find out what side effects occur when they are given~     together.~   "
173352|NCT01296022|"~     This randomized controlled trial will outline the advantages and disadvantages of the~     subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.~   "
173353|NCT01296009|"~     To investigate the impact of traditional Chinese medicines (TCM) on embryonic implantation in~     the patients who have underwent in vitro fertilization and embryo transfer, the investigators~     compare the pregnancy rate in traditional Chinese medicine group and control group. The~     hypothesis is that pregnancy rate in traditional Chinese medicine group is higher than the~     control group.~   "
173354|NCT01295970|"~     Usually the treatment of a single brain metastasis is surgery or Stereotactic Radiosurgery~     (SRS). Surgery involves resection of the brain tumor by means of an operation, whereas SRS is~     treatment consisting of highly focused radiation doses to the tumor. These two treatment~     modalities are both widely used, well established, and proven to improve survival, but so~     far, no study has been done to directly compare the efficacy of one over the other. Neither~     treatment in itself is considered to be experimental and both have been shown to provide~     benefits to patients with metastatic brain tumors. The aim of this study is to determine~     which two modalities are better for local control and improving quality of life.~      Patients who consent to this study will be randomized to either receive surgery or~     Radiosurgery in the treatment of single brain metastases. The study seeks to recruit 12~     patient to each group. Patients will be in this study for up to five years from the time of~     the treatment finished. This will include follow-up visits at 4 weeks after the procedure and~     then every 3 months after the procedure up to 5 years.~   "
173357|NCT01295931|"~     Objectives:~        1. To determine the feasibility of using microdose amounts of near-infrared (NIR)~          fluorescent contrast agent to image tumor-draining and contralateral lymphatics in~          melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion~          lymph node dissection (axillary or inguinofemoral)~        2. To determine the feasibility of using nonradioactive optical imaging techniques with~          indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic~          architecture and function by correlating the observed lymphatic structure and function~          with tumor and nodal status as determined from standard-of-care immunohistochemical~          evaluation.~   "
173361|NCT01295879|"~     Vitamin D plays a critical role in maintaining bone health, as well as preventing~     cardiovascular disease, cancer, and various autoimmune diseases, such as diabetes. Vitamin D~     deficiency is very common in the United States and worldwide, and is now being increasingly~     recognized and treated. One group in which vitamin D deficiency may be particularly important~     is patients who have had kidney stones. These patients frequently have elevated levels of~     calcium in their urine, which is a common and important risk factor for calcium containing~     kidney stones. Because vitamin D increases absorption of calcium into the blood by the~     intestines, physicians may be reluctant to prescribe vitamin D therapy to patients with~     vitamin D deficiency if they also have kidney stones and high amounts of calcium in the~     urine. They are concerned about the possible risk of increasing the amount of calcium in the~     urine (and thereby increasing the risk of calcium stones occurring again). However, studies~     in patients without kidney stones, as well as studies in patients with high calcium levels in~     the urine, have demonstrated that giving vitamin D is effective and safe and does not~     increase calcium in the urine. Therefore, the investigators will study the effects of giving~     vitamin D on the amount of calcium in the urine in patients with a history of kidney stones~     and elevated calcium in the urine. The investigators will evaluate the safety of giving~     vitamin D to this particular group of patients.~   "
173362|NCT01295866|"~     Nitric oxide (NO) was considered as a mediator of nasal inflammation and the measurement of~     nasal nitric oxide (nNO) may assist in the diagnosis of nasal inflammation. Few data exists~     comparing nNO with established, larger accepted reference standard for chronic rhinosinusitis~     (CRS) diagnosis. Moreover, the role of atopic status on nNO in nasal inflammatory diseases~     has not been reported. The aim of our study was to determine the value of nNO in patients~     with chronic nasal inflammation, and to assess the relationship between nNO and atopic status~     in these patients. A total of 131 randomized patients suffering form chronic nonallergic~     nasal inflammation and 20 healthy volunteers were finally recruited. nNO was measured by NIOX~     devices. Sinus computed tomography (CT) scan, nasal endoscope and nasal symptoms evaluation~     were used in the different diagnosis of chronic rhinitis (CR), CRS without nasal polyps~     (CRSsNP) and CRS with nasal polyps (CRSwNP). Atopic status was confirmed by skin prick test~     and serum IgE levels. Blood eosinophils were evaluated simultaneously. Relationships among~     nNO, various atopic characteristics and chronic nasal inflammation were evaluated.~   "
173363|NCT01295853|"~     T3 versus T4 as a primary treatment for palmer hyperhydrosis and effect on postoperative~     compensatory hyperhydrosis~   "
173364|NCT01295840|"~     The purpose of this Clinical Trial is to determine the percentage of patients whose~     hemodynamic response improves with the different configurations offered by the new Quartet®~     left ventricular lead, as a result of its four electrodes, with respect to the configurations~     offered by a standard bipolar lead.~      Furthermore, the optimal stimulation configuration will be determined from a comparison with~     traditional configurations.~   "
173365|NCT01295827|"~     This study will be done in 6 parts. In Part A the dose of intravenous (IV) pembrolizumab~     (MK-3475) will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2~     dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of~     any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety,~     tolerability, and efficacy of the drug in participants with advanced or metastatic MEL and~     compare every 2 week to every 3 week dosing. Part C of the study will explore the safety,~     tolerability, and efficacy of the drug in participants with non-small cell lung carcinoma~     (NSCLC) that is locally advanced or metastatic. Part D of the study will explore the low and~     high doses of study drug identified in Parts A and B in participants with advanced or~     metastatic MEL. Part E (closed with Amendment 7) will explore low, medium, and high doses of~     study drug in combination with standard chemotherapy in participants with locally advanced or~     metastatic NSCLC. Part F will explore low and high doses of study drug in treatment-naive and~     previously-treated participants with NSCLC with programmed cell death 1 ligand (PD-L1) gene~     expression. In Parts D and F and some of Part B participants will be randomized to one dose~     level. The primary hypotheses are the following: that pembrolizumab has acceptable safety and~     tolerability; and that pembrolizumab shows a clinically meaningful response rate (RR) or~     disease-control rate (DCR) in participants with melanoma (ipilimumab-refractory or not), and~     a clinically meaningful RR in participants with NSCLC, especially a clinically meaningful RR~     in those participants with either cancer, whose tumors express PD-L1.~   "
173366|NCT01295814|"~     The purpose of this study is to evaluate an investigational treatment for interstitial~     cystitis. Interstitial cystitis is a chronic bladder disease that includes the following~     symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and~     bladder discomfort relieved by voiding.~      Presently, there is no cure for interstitial cystitis. The response to current treatments is~     poor. Patients with interstitial cystitis have a poorer quality of life. The cause of~     interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for~     improving the symptoms of patients with interstitial cystitis. Humira® is an injectable~     anti-inflammatory medication that has been available for use since December 31, 2002. Humira®~     has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing~     spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial~     cystitis. This study will evaluate an investigational use of Humira® for the treatment of~     interstitial cystitis.~   "
173367|NCT01295801|"~     Linezolid is the first approved synthetic oxazolidinone that is active against~     multidrug-resistant Gram-positive pathogens. Because of its significant efficacy, linezolid~     is widely used in clinical treatment. However, the side effects of linezolid commonly lead to~     anemia and thrombocytopenia. This hematological toxic effects limit its prolonged used. The~     investigators have found that Vitamin B6 application, as a preventive, auxiliary therapy, can~     relieve anemia and thrombocytopenia. The present study was designed to verify the effects of~     Vitamin B6 in the prevention of linezolid-associated cytopenias and investigate its~     mechanism.~   "
173368|NCT01295788|"~     The investigators hypothesize that REAL-Time Continuous Glucose Monitoring (RT-CGM) will be~     more effective if introduced in children and adolescents with established diabetes at the~     same time as they are starting pump therapy. This randomized controlled trial will compare~     the effectiveness of simultaneous vs delayed introduction of RT-CGM in children and~     adolescents with type 1 diabetes who are starting insulin pump therapy.~   "
173369|NCT01295775|"~     The aim of this phase 2 controlled placebo study is to assess the effectiveness of Sulodexide~     in the treatment of non proliferative (background) retinopathy in patients with Type 1 and~     Type 2 Diabetes Mellitus.~      This is a multicentre, double-blind, randomised study involving patients affected by non~     proliferative (background) diabetic mild to moderate retinopathy.~      This study will involve 130 patients (65 for each group). At baseline visit (T0), the~     Investigator will grade the ocular lesions due to diabetic retinopathy according to color~     fundus photographs and the fluorescein angiography examination. He will subsequently send the~     negatives of photographs and the images -or negatives when available- of fluorescein~     angiography to an off-site Assessor -unaware of the Investigator assessment- nominated to~     confirm the quality of the images and the grade of the lesions. After positive assessment of~     the Investigator, at T0 the eligible patient will be blindly allocated to one of the 2~     treatment groups according to a computer-generated randomisation list provided by the~     Sponsor.~      The following treatments will be administered for 360 days:~      A (SULODEXIDE GROUP): 50 mg a day by oral route;~      B (PLACEBO GROUP): Sulodexide placebo at the same schedule and for the same lengths of time~     as group A.~      Before breaking the randomisation code at the end of the study, an independent off site~     assessor will evaluate the photographs according to the Airlie House Classification and~     following modification by Early treatment Diabetic Retinopathy Study (ETDRS) and fluorescein~     angiography according to ETDRS.~   "
173370|NCT01295762|"~     Apart from brain tumors, Neuroblastoma is the most common solid tumor during childhood. About~     50% of the cases present at diagnosis with factors of bad prognosis. During the last two~     decades, despite increased therapeutic intensity during induction and consolidation of~     high-risk neuroblastomas, the 5 year overall survival of high risk neuroblastoma remains in~     between 30 to 40% depending on studies.~      Besides strategies of high-dose chemotherapy followed by autologous transplantation of~     hematopoietic stem cells, and differentiating molecules (retinoids), immunotherapy will~     become one of the leading anti-neuroblastoma targeted therapy. No therapeutic strategies or~     molecules obtained such gains of survival ever before.~      Studying the immune system of children with neuroblastoma at diagnosis and during their~     treatment will help us to determine when we should test active or passive immunotherapy~     strategies. Moreover, this study would allow us to specify the cause of tumor immune~     tolerance in neuroblastoma, on which we have few data in comparison to adult tumors.~      This will be a multicentric, pilot, prospective, open, study that will not require unusual~     diagnostic interventions. This study will be transversal (all neuroblastoma stages included)~     in order to determine comparative criteria between low and high risk neuroblastoma. It will~     also be longitudinal (from diagnosis to post-treatment follow-up) in order to specify~     evolutionary aspects of immunity under radio-chemotherapy and retinoic acid therapy.~      Immunological analyses will be done on blood, bone marrow and tumor samples, at diagnosis,~     and during the treatment of children diagnosed for neuroblastoma (up to 3 time points). These~     types of samples are routinely done during conventional neuroblastoma treatment.~   "
173371|NCT01295749|"~     International recommendations stress on the importance of no flow time reduction in cardiac~     arrest management. In fact, no flow time is an independent factor of morbidity and mortality.~      In France, cardiac arrests are treated by first responders (including emergency nurses)~     before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask~     for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation~     rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The~     purpose of our study is to compare the no flow time between two strategies of out of hospital~     cardiac arrest management by first responders: conventional CPR with bag-valve-mask~     ventilation vs. compression only CPR with Laryngeal Tube ventilation.~   "
173372|NCT01295736|"~     Digital ulcers (DUs) are an expression of the microangiopathy in patients with scleroderma~     (SSc). DUs lead to pain and impaired hand use. DUs remain a severe complication for many~     patients and effective therapy remains elusive. In the present study, the investigators~     propose to evaluate the efficacy of Sildenafil in DUs healing in a randomized double blind~     control study in SSc patients.~   "
173373|NCT01295723|"~     The purpose of this research study is to find out the effects (good and bad) of adding a dose~     of radiation to the area of the cancer during surgery to whole breast radiation therapy~     (WBRT) after surgery. IOERT is the application of electron radiation directly to the residual~     tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used to treat~     patients who have cancer in the breast covering the entire breast tissue. Both immediate and~     long-term effects will be measured.~      For patients with certain types of breast cancer, one standard treatment is removal of the~     area of cancer and a small amount of normal tissue around it followed by breast radiation.~     The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks of WBRT followed by~     5-8 daily radiation treatments at the site where the lump was removed called a boost.~     During this study, the single dose of electron irradiation (IOERT) given at the surgical site~     during the operation will replace the usual 5-8 days of localized radiation and the whole~     breast radiation will last 3 weeks.~   "
173374|NCT01295710|"~     The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to~     standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe~     chronic GVHD-free survival.~   "
173375|NCT01295697|"~     The goal of this clinical research study is to find the highest tolerable dose of EZN-2208~     that can be given to pediatric patients with Relapsed or Refractory Solid Tumors. The safety~     of the study drug and its effect on the disease will also be studied.~   "
173376|NCT01295684|"~     Previous studies have shown that consumption of a low calorie cranberry beverage imparts a~     favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men.~     However, these studies were not well controlled. Thus, it is important to confirm these~     effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify~     the cardioprotective effects of cranberries by conducting a dietary intervention trial with~     healthy subjects in a controlled environment.~   "
173377|NCT01295671|"~     The overall aim of the study is to compare the effects of three types of beverages -~     sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on~     cardiovascular disease (CVD) risk factors and body weight among young adults.~   "
173378|NCT01295658|"~     Cancer Survivor Registry: The Breast Cancer M.A. P. (Mind Affects the Physical M.A.P.)~     Project to identify and help us understand the emotional and social needs of breast cancer~     survivors.~   "
173380|NCT01295632|"~     This is a two part study of the drug MK-8669 (ridaforolimus) given with MK-2206 or MK-0752.~     In Part A of the study, the preliminary maximum tolerated dose (MTD) of the drug combinations~     will be found by giving sequentially higher doses of the study drugs. An expansion cohort of~     participants may be enrolled to confirm the MTD. New cohorts at other dose levels may be~     enrolled, depending on the rate of dose limiting toxicities (DLTs) in the planned cohorts. In~     Part B, an assessment of the efficacy of the drug combinations against selected advanced~     cancers will be made so that a recommended dose to be used in Phase 2 studies (RPTD) can be~     found. As of 19 July 2012 the MK-0752 arms of the study were fully enrolled and closed to~     further recruitment. As of 30 November 2012, no additional participants with prostate cancer~     will be enrolled.~   "
173381|NCT01295619|"~     This is a prospective study to evaluate the performance and safety of a new medical device~     used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.~   "
173382|NCT01295606|"~     To document cefazolin disposition (concentration/time profile, protein binding, metabolism,~     renal elimination characteristics) and its covariates in neonates following intravenous~     administration of the drug at induction of anesthesia, prior to an invasive procedure~      To evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed~   "
173383|NCT01295593|"~     Rationale New chemotherapeutic agents are needed in relapsing B-Cell Chronic Lymphocytic~     Leukemia (B-CLL) to overcome resistance of CLL cells. Valproic acid (VPA) is an inhibitor of~     histone deacetylase (HDAC) used as an anticonvulsant and mood-stabilizing drug for decades.~     VPA mediates apoptosis in CLL cells through caspase activation. VPA shows toxicity toward CLL~     cells displaying alterations in the p53 pathway. The combination of VPA with fludarabine or~     2-Chlorodeoxyadenosine (CdA, Cladribine) results in synergistic loss of B-CLL cell viability,~     and significant increase in apoptosis. The highest index of synergism is observed between VPA~     and CdA, a purine nucleoside analog active in B-CLL.~      Study design Overall, the study will be proposed to previously treated patients with advanced~     B-CLL, who are not eligible for aggressive approaches, and who exhibit progressive disease. A~     total of 33 patients will be included. Estimated enrolment time is 2 years.~        -  First part: It is planned to start therapy with single VPA during 2 months, targeting~          plasma levels that have been reported to be active in vitro toward CLL cells (but that~          do not exceed therapeutic levels in seizure prevention), and in parallel, to verify~          whether cellular targets of VPA have been actually inhibited in leukemic B-lymphocytes.~        -  Second part: After the VPA preloading period (2 months), patients will be evaluated to~          receive CdA. CdA will be given at 5.6 mg/m²/day intravenously during 3 days, a~          reduced-dose schedule which is less toxic - at no obvious cost of loss of efficacy - as~          compared to the standard dosage of 5 days. CdA was chosen because it displays the~          highest level of in vitro synergism with VPA. Four monthly courses of CdA will be given.~          Patients will then be evaluated. VPA will be stopped at the time of response evaluation~          (scheduled 28 days after the last course of CdA).~   "
173384|NCT01295580|"~     The purpose of this study is to determine the comparative safety and efficacy of knee~     intra-articular injection of hyaluronic acid obtained from two different sources in the~     treatment of knee osteoarthritis.~   "
173385|NCT01295567|"~     Rationale:~      Due to western lifestyle human coronary arteries are prone to develop atherosclerotic~     plaques. Hence the heart is an important target organ for atherothrombotic complications:~     myocardial ischemia, arrhythmias, myocardial infarction and heart failure. To alleviate~     symptoms and decrease mortality in these patients, myocardial revascularisation is~     recommended. Coronary artery bypass grafting (CABG) is indicated in patients with severe~     atherosclerotic disease of all three coronary arteries or the left main stem coronary artery.~     Cardiac ischemia and reperfusion injury during CABG is inevitable and jointly accountable for~     complications that occur after CABG (e.g. death, myocardial infarction, arrhythmias, stroke,~     or renal complications). Dipyridamole has been shown to reduce ischemia reperfusion injury in~     healthy volunteers using an intermediate endpoint and may prevent cardiovascular death or~     event in secondary prevention after cerebrovascular disease. The investigators hypothesise~     that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against~     ischemia and reperfusion injury due to CABG. The investigators expect lower troponin-I~     release in patients who were pretreated with dipyridamole.~      Objective: To study the effect of oral pretreatment with dipyridamole on high sensitivity~     (HS)-troponin-I release after CABG. Secondary objectives are whether oral pretreatment with~     dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic support, and~     duration of Intensive Care-stay. Further secondary endpoints are the effects of dipyridamole~     pretreatment on renal injury and post-ischemic recovery of contractile function (measured~     ex-vivo).~      Hypothesis:~      The investigators hypothesize that oral pre-treatment with dipyridamole can increase cardiac~     tissue tolerance against ischemia and reperfusion injury. The investigators expect lower~     HS-troponin-I release in patients who were pretreated with dipyridamole. Additionally the~     investigators expect the incidence of arrhythmias, need for prolonged inotropic support~     (longer than 24 hours postoperative) to be decreased in pretreated patients.~   "
173386|NCT01295554|"~     Magnetic Resonance Angiography (MRA) of the peripheral arteries has become essential in the~     diagnosis and follow-up of peripheral arterial disease.~      In clinical routine, the acquisition uses intravenous injection of a Gadolinium based~     contrast agent (gadolinium chelates).~      Initially, contrast enhanced MR angiography (CE-MRA) was recommended for diabetic patients,~     elderly patients and\or patients with chronic renal insufficiency presenting a~     contraindication to CT angiography using iodized contrast agent injection.~      However, the increase in nephrogenic systematic fibrosis clinical cases, which would be~     secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has~     restricted the use of CE-MRA. More than 500 cases were described to date in the world.~      Its occurrence is currently estimated around 4 % for patients in terminal chronic renal~     insufficiency and its mortality around 30 %.~      According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agents~     (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST~     *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30~     ml/mn.~      Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide~     complete and non-invasive investigation of the peripheral vasculature, from the abdominal~     aorta to the calf, thus offering patients with chronic renal insufficiency a surrogate with~     no side effects.~      Moreover, the use of high field (3T) MR imaging and phased array coils offers high quality~     images and good signal to noise ratio for peripheral vasculature analysis.~      Besides, the acquisition can be repeated if required as it does not require any contrast~     injection.~      The main objective is to evaluate the quality of the NCE images obtained for every~     investigated station from the abdominal aorta to the calf.~      The secondary objective is to compare the diagnostic performances of NCE images with those of~     CE MRA.~      The third objective is to estimate the contribution of automated and dedicated~     post-processing tools in optimizing the diagnostic quality of the images.~   "
173387|NCT01295541|"~     The current study is proposed to assess the frequency and type of progressive mobility~     procedures currently performed in the CVICU The study will evaluate the type and frequency of~     progressive mobility orders, whether or not progressive mobility steps are being taken by the~     nursing teams, define what steps patients are receiving, and record time to first weight~     bearing. Other outcome measures will be the days of required mechanical ventilation, and~     current ICU length of stay and cost to treat.~   "
173388|NCT01295528|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the function of device.~        2. Test methods and procedures: Performance test in two positions: Seated and Supine.~        3. DUT: Transtek Blood Pressure Monitor, Model: TMB-986. Cuff size: 22-32cm and 22-42cm.~        4. Comparison device: Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.~        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Meet the requirements of SP10.~   "
173468|NCT01294488|"~     The overarching aim of the proposed study is to test the implementation effectiveness of two~     implementation approaches—Remote Real-Time (RRT) using the internet telemedicine technology~     and traditional Phone Consultation (PC) for training practitioners in PCIT. The study will~     add to emerging knowledge about how technology can facilitate the transport of evidence-based~     intervention models into field settings.~   "
173389|NCT01295515|"~     Background:~        -  Antiretroviral therapy (ART) has been able to improve the lifespan of individuals~          infected with human immunodeficiency virus type 1 (HIV-1), but ART requires continuous~          treatment that has substantial consequences on quality of life. ART suppresses HIV-1~          virus levels below the limits of detection in current tests, but does not completely~          eradicate the virus from the blood. Recent research is attempting to determine whether~          this persistent infection stems from a low-level infection where new cells are~          continually infected with HIV, or from cells that live for a long time after infection.~          ART is very active against the virus in new cells, but has no effect on long-lived cells~          that are already infected with HIV-1 at the start of ART. As a result, new strategies~          may be necessary to reduce or eradicate these 'reservoir' cells.~        -  Interferon is a natural substance made by the body to combat virus infections, but can~          also be made as an injectable drug known as PEGINTRON. PEGINTRON injections have been~          approved to treat hepatitis C infection, including in patients with HIV infection.~          Earlier studies of HIV-infected individuals who were not on any ART showed that~          interferon reduced the level of HIV in the blood. Researchers are interested in~          determining whether PEGINTRON therapy will also reduce the residual low levels of HIV in~          patients who are already taking ART.~      Objectives:~      - To evaluate the effectiveness of PEGINTRON injections on HIV levels in participants~     currently undergoing antiretroviral therapy.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with HIV, are currently~     undergoing antiretroviral therapy, and have maintained HIV virus blood counts that are not~     detectable by current commercial tests for at least 12 months before the start of the study.~      Design:~        -  This study will involve separate screening and treatment processes.~        -  Participants will be screened with a physical examination and medical history, including~          blood and urine samples. The screening analysis to determine study eligibility will take~          several weeks. Participants will have apheresis to provide sufficient numbers of blood~          cells for evaluation by the study researchers.~        -  Eligible participants will begin a 4-week course of PEGINTRON injections using the~          standard dose of PEGINTRON that is approved for treatment of chronic hepatitis C.~          Participants will have weekly injections and have frequent blood tests to measure HIV~          virus levels.~        -  Participants who experience problems in maintaining safe numbers of white blood cells~          during the study may receive injections of filgrastim to increase their white blood cell~          count.~        -  After the 4 weeks of treatment, participants will return for additional blood tests on~          study days 28, 35, 42, 49, 56, and 84, and Weeks 16, 24, 36, and 48 (i.e., through the~          end of 1 year after the start of the study).~   "
173390|NCT01295502|"~     This phase I trial studies the side effects and the best dose of paclitaxel and carboplatin~     after cisplatin and radiation therapy in treating patients with stage IB-IVA cervical cancer.~     Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to~     kill tumor cells. Giving paclitaxel and carboplatin after cisplatin and radiation therapy may~     kill more tumor cells.~   "
173391|NCT01295489|"~     This research trial studies biomarkers in patients with previously untreated invasive ovarian~     epithelial, fallopian tube, or primary peritoneal cancer. Studying samples of tumor tissue,~     peritoneal cavity fluid, and blood from patients receiving chemotherapy directly into the~     abdominal cavity (intraperitoneal) may help doctors learn more about the effects of~     intraperitoneal chemotherapy on cells. It may also help doctors identify and learn more about~     biomarkers related to cancer.~   "
173392|NCT01295476|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in bone marrow samples from patients with~     T-cell acute lymphoblastic leukemia.~   "
173393|NCT01295463|"~     RATIONALE: Learning about the amount of information on fertility and infertility by patients~     before they received treatment for cancer in a comprehensive cancer center may help doctors~     plan the best treatment.~      PURPOSE: This clinical trial is studying the amount of information on fertility and~     infertility received by patients before treatment of cancer in patients who have finished~     treatment.~   "
173394|NCT01295450|"~     The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC~     compared to vitamin complex, in the treatment of lack of appetite and prevention of~     deficiency of B and C vitamins.~   "
173395|NCT01295437|"~     Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of~     this study was to compare long-term results of hernioplasty using three different meshes~     (partly absorbable, lightweight polypropylene and thick polypropylene mesh).~   "
173396|NCT01295424|"~     Observational study of all out-of-hospital cardiac arrest during 6 months in regional areas~     of Helsinki University Hospital and Kuopio University Hospital from activation of EMS system~     until follow up to 6 months of survival.Simultaneous observation of out-of-hospital cardiac~     arrest primary survivors admitted to all Finnish ICUs.~   "
173397|NCT01295411|"~     The aim of the investigators analysis is to identify the neural correlates of quality of life~     scores in schizophrenia. For this, the investigators will constitute group of patients~     according to their quality of life scores and the investigators will analyze their~     differences in patterns of brain structures and activations.~   "
173398|NCT01295398|"~     The aim of the investigators study is to compare in children aged less than 18 months and~     hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile~     ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm),~     or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a~     mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).~   "
173399|NCT01295385|"~     Diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary~     microcirculation linked to an endothelial dysfunction. Abnormalities of the myocardial~     metabolism is frequently associated. It is regrettably about a hypothesis difficult to verify~     with current medical techniques.This deficiency being not only harmful to the diagnosis, but~     also to the assessment of the efficiency of the medical treatment on the myocardial~     metabolism and the endothelial function. Techniques of nuclear magnetic resonance offer~     interesting perspectives.~   "
173400|NCT01295372|"~     To assess the effect of zicronapine versus risperidone on metabolic parameters comprising~     body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and~     glucose during 6 months of treatment.~   "
173411|NCT01295229|"~     The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most~     significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass~     (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through~     mechanisms beyond just weight loss, but its role in diabetes management and the nature of its~     weight-independent anti-diabetes effects are not well established because of a paucity of~     appropriate randomized trials, the execution of which is hindered by numerous obstacles. The~     investigators therefore propose a feasibility study to demonstrate our capacity to identify,~     recruit, randomize, and track outcomes for 40 adult Group Health members identified as having~     T2DM and a BMI between 30-40 kg/m2.~   "
173401|NCT01295359|"~     The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and~     mortality, so it's important to find actions that could improve quality of life and decrease~     the mortality. The objective of this study is to verify if a ground walking program applied~     to hospitalized exacerbated COPD patients has effects in quality of life, exercise capacity,~     airways obstruction, body composition, heart rate variability, quadriceps isometric force and~     in the Body-mass index, Airway Obstruction, Dyspnea, Exercise Capacity index (BODE index).~     An evaluators-blinded randomized controlled study will be conducted in Hospital Escola~     Municipal de São Carlos where forty patients will be recruited to participate. The~     volunteers will be randomized in two groups with twenty patients, the usual care group, that~     will receive only the usual care of the hospital; and the trained group that will receive the~     same care, but will also participate in a ground walking program associated with respiratory~     exercises. It will be evaluated, in the start and at the end of the program, the health~     related and general quality of life and the Barthel index. Daily, the patient will be~     submitted to the Six Minute Walk Test, to a body composition analysis, to a hand grip test~     and to a dyspnea assessment, and will be calculated its BODE index. All patients will be~     invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would~     receive the same evaluation of the last day in the hospital. All the collected data will be~     expressed in means and standard deviations or medians and range when appropriated. It will be~     chosen appropriated tests to compare and correlate them.~   "
173402|NCT01295346|"~     The purpose of this study is to assess if putative brain injury biomarkers have utility as~     blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be~     accomplished by examining the relationships between potential serum-based TBI biomarkers and~     clinical measures of injury severity, occurrence of complications, and outcome, in subjects~     with mild or moderate TBI. The assay will be evaluated in a sample population of subjects~     over the age of 18 who have been referred to the health care provider for closed head injury~     evaluation.~   "
173403|NCT01295333|"~     The aim of our study is to compare in a randomized multicentric study the early prophylactic~     introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm)~     compared to a conventional approach based on the initiation of LT4 as soon as the first~     biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or~     minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy~     (clinical activity score to 0) will be included in this study. The administrated iodine-131~     activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue).~     Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The~     primary objective will assess differences in terms of quality of life at 3 months using a~     specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes~     at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck),~     autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy~     and medico-economic data.~   "
173404|NCT01295320|"~     The subjects included in this study are subjects that participated in study NCT00434577.~     These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and~     Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for~     safety and immunogenicity.~      This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and~     safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.~      The study visits will be scheduled at approximately one year intervals after the first visit~     in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be~     taken from all subjects at each visit. Information on safety and the occurrence of HZ will~     also be collected during these visits.~   "
173405|NCT01295307|"~     In relapsed or refractory AML allogeneic HCT is considered to be the only treatment by which~     long-term disease-free survival can be achieved. Despite this favorable prospect, even in~     younger patients with relapsed AML only about 40% of the patients reach allogeneic HCT. A~     number of factors contribute to this low rate of transplantation, among them moderate~     activity of the salvage regimens and accumulating toxicities which prevent from~     transplantation; Prospective clinical trials in this indication usually focus either on the~     rate of CR achieved after a defined number of cycles of salvage therapy or on transplantation~     modalities. The consequent integration of salvage therapy into a transplant strategy~     accounting for the time-dependent process of donor search has not been studied so far.~      The objective of this study is to evaluate the safety and efficacy of clofarabine salvage~     therapy prior to allogeneic HCT.~   "
173406|NCT01295294|"~     The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic~     acid) can control irregular bleeding during the first 3 months of using Mirena. The study~     drugs tested are tested against placebo (dummy medication not containing any active drug).~     Treatment period is followed by a one-month period when study drugs are not taken but Mirena~     use is continued.~   "
173407|NCT01295281|"~     The hypothesis to be investigated is if the tolerability of intermittent catheterization with~     Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e.~     clinically non-inferior when using POBE 2.0 compared to PVC.~      Secondary objectives are to evaluate the safety and the subject's perception associated with~     the use of the catheters, assessed by the recording of adverse events and the ease of~     handling by means of a subjective assessment scale.~   "
173408|NCT01295268|"~     The goal of this study is to determine if vulvar (external female genitalia) pain is~     decreased with emu oil over a similar placebo oil (no active ingredient) by using measurement~     devices, examinations, and questionnaires. Topical emu oil has not been scientifically~     studied for this condition yet, but related reports show no significant side effects or~     potential benefits.~      A total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.~   "
173409|NCT01295255|"~     Allergic rhinitis (AR) and asthma are considered as one airway, one disease. Although there~     is increasing evidence for an association between allergy and depression, it remains unknown~     if the relationship between AR and asthma has extra influence on the psychological status of~     the patients. The aim of our study was to investigate the influence pattern of asthma on the~     psychological status in AR patients. The Symptom Checklist-90 (SCL-90) was employed to~     analyze the psychological status of 524 individuals with AR. Independent sample T-tests,~     one-way ANOVA and multivariate ANOVA were used for data analyses.~   "
173412|NCT01295216|"~     Nearly half of the adult population in Latin American urban settings has abnormally high~     blood pressure. Although half of these subjects with high blood pressure are still in the~     pre-hypertensive stage (systolic blood pressure values in the 120-139 mmHg range or diastolic~     blood pressure in the 80-89 mmHg range), the rate of progression to hypertension is high~     (10-20% per year), according to studies done in other settings. The main objective of this~     proposal is to evaluate the effectiveness of an affordable and sustainable primary health~     care intervention to reduce blood pressure and prevent progression from pre-hypertensive~     status to hypertension in individuals at poor urban clinics in Argentina, Guatemala, and~     Peru. Our primary hypotheses are that pre-hypertensive subjects who receive mHealth (mobile~     health) support for 12 months (intervention group) will have lower blood pressure compared to~     individuals who receive the usual primary health care (control group); and that~     pre-hypertensive subjects will maintain lower blood pressure six months after receiving~     mHealth support. The investigators will determine the effects of an intervention using~     mHealth technology, including short message services (SMS) and one-to-one telephone calls, to~     promote lifestyle modification focused on reducing blood pressure among participants. The~     intervention also aims to help participants become better informed, motivated, and encouraged~     to practice self-management of their own health; to improve patient satisfaction levels;~     provide tailored targeted interventions; and to improve patient-provider relationships. The~     proposal is designed as a proof-of-concept intervention in three Latin American countries~     that encompass a wide range of environments and health care settings. A total of 212 subjects~     (30-60 years old) per country will be recruited in primary health clinics and randomized to~     study groups. Blood pressure, anthropometry, and behavioral risk factors (physical activity,~     diet, stress, alcohol and tobacco use) will be measured at baseline and at months 6 and 12~     during the intervention, and six months after the end of the intervention. The investigators~     will also evaluate feasibility, acceptability, cost-effectiveness, and process implementation~     of the intervention.~   "
173413|NCT01295203|"~     The purpose of this study is to determine whether access to a website with personalized~     feedback on physical activity level and suggestions to increase physical activity results in~     improvements in self-reported physical activity, anthropometrics and physiological~     measurements~   "
173414|NCT01295190|"~     Propofol has been routinely used for general anesthesia during pediatric cardiopulmonary~     bypass at our institution without complications. However, propofol may cause propofol~     infusion syndrome (PRIS), a rare, but often fatal complication mainly defined by bradycardia~     with progress to asystolia. Metabolic acidosis is regarded as an early warning sign of PRIS.~     Due to the preconditioning effects of sevoflurane and its availability for cardiopulmonary~     bypass, propofol has recently been substituted by sevoflurane during pediatric~     cardiopulmonary bypass at our institution. In this study the effect of substituting propofol~     by sevoflurane on metabolic acidosis and outcome are examined.~   "
173415|NCT01295177|"~     The purpose of this study is to determine whether topic insulin is effective to accelerates~     wound healing in diabetes patients~   "
173416|NCT01295164|"~     The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual~     simulator (AOVIS-I). The system provides an objective characterization of the optical quality~     of the patient's eye by application of wave-front sensing technology. The optical condition~     of every eye is represented by its wave aberration. This characterization overcomes the~     current description based only in refractive errors. This provides an accurate description of~     the optics of the eye based on the assessment of the whole set of ocular aberrations. The~     particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this~     wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as~     patients with keratoconus.~   "
173417|NCT01295151|"~     The principal aim of this study is to fill a clear knowledge gap and provide guidance for~     rheumatologists and reassurance to the patient group on a management challenge faced daily in~     rheumatology practice. Specifically, it aims to provide robust evidence on the optimal~     management of patients with established RA that have failed an anti-TNF therapy (the first of~     the biological therapies to be introduced); in particular, the investigators wish to address~     whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or~     abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is~     to broaden treatment options and target these specific therapies to disease sub-groups.~   "
173418|NCT01295138|"~     Constipation following elective Caesarean sections (CS) is a common problem experienced by up~     to 50% of patients (1). The causes for this are multifactorial and include manipulation of~     the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic~     techniques. To try to alleviate the problem of postoperative constipation, some anaesthetists~     prescribe postoperative lactulose in addition to postoperative analgesia, although no data~     exists that shows whether this has any beneficial effect on postoperative constipation.~      1. Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4).~   "
173419|NCT01295125|"~     The purpose of this study is to compare open abdominal incisional hernia repair using~     XenMATRIX biologic mesh versus repair with their own tissue. This study will provide~     information in determining if a biological mesh is necessary to provide a sturdy repair for a~     ventral hernia.~   "
173420|NCT01295112|"~     This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®)~     eye injections reduces the need for repeat bevacizumab eye injections in patients with~     nonischemic central retina vein occlusion.~   "
173421|NCT01295099|"~     To clarify the mechanisms of Keloid scar formation.~      Elucidate the action and therapeutic value of 5-FU in Keloid scar treatment~      Identify the genetic link with Keloid scar formation.~      Quantify the psychological/social impact in keloid scarring patients~   "
173422|NCT01295086|"~     The primary aim of this dose-finding study is to determine the maximum tolerated dose of~     taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third~     week as first-line treatment in patients with HER2-positive advanced gastro-esophageal~     cancer. Secondary end points are to evaluate progression-free survival and overall survival.~   "
173423|NCT01295073|"~     The primary purpose of the protocol is to evaluate whether Trientine Hydrochloride, a copper~     chelator which is an agent that binds with and removes copper, will be effective in~     minimizing macular edema after cataract surgery in individuals with type 2 diabetes. It is~     our hypothesis that there will be a reduction in copper-attributed inflammation after surgery~     resulting a decrease in edema.~   "
173424|NCT01295060|"~     This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide~     Implant in patients that were previously treated with an Octreotide implant.~   "
173425|NCT01295047|"~     The investigators are looking at the different impacts of atenolol, verapamil and perindopril~     on large artery and lv function in marfan syndrome. It is a double-blind, randomised~     cross-over trial.~   "
173469|NCT01294475|"~     The goal of this project is to examine the effects of the use of cellular-phone technology in~     conjunction with a parenting program entitled Planned Activities Training (PAT) on~     participant enrollment, engagement, and motivation for the PAT intervention, as well as on~     parent and child outcomes.~   "
173426|NCT01295034|"~     The ability of vitamin D to modulate the immune system and strengthen bones may mitigate the~     adverse medication consequences of HIV/AIDS, but little is known about either the health~     benefits of vitamin D supplements, or about the optimal dosing regimen for patients on highly~     active antiretroviral therapy (HAART). This trial is a comparison of two regimens for~     administering vitamin D and calcium to HIV-positive individuals taking antiviral medications.~     This study will help physicians make evidence-based decisions about the most effective way to~     use vitamin D in their patients and enable the design of large multi-center trials in the~     future.~   "
173427|NCT01295021|"~     The purpose of this NIS is to assess the prevalence of sympathetic overactivity in patients~     with newly diagnosed essential hypertension.~   "
173428|NCT01295008|"~     The purpose of this study is to assess whether patients with the classic form of Fabry~     disease have significantly less androgenic alopecia (male pattern baldness).~   "
173429|NCT01294995|"~     Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term~     Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and~     CVD risk factors. Guizhou Meijiao Liquor (GML) is a traditional Chinese liquor, fermented~     from sorghum, corn, sticky rice, wheat and rice, while TFL is a novel Chinese liquor~     fermented from above 5 grains plus green tea.~      Forty-five volunteers(23 males, 22 females) were selected to participate a paralleled~     randomized trial drinking 30 mL two kinds of Chinese liquors: TFL and GML respectively with~     meal every day for 28 days. Serums of volunteers were collected for analyzing serum lipids,~     inflammation biomarkers and CVD risk factors.~      TFL could significantly decrease systolic blood pressure of males, but increase diastolic~     blood pressure of females. TFL could also decreased blood lipid of volunteers, especially for~     females. Both liquor significantly decrease serum uric acid and glucose in males and females.~     The effect of the two liquors on inflammation biomarkers were complicated and needs further~     research work.~      TFL may possess more beneficial effect on CVD risk factors than GML probably because of the~     special fermentation products of green tea with other grains.~   "
173430|NCT01294982|"~     The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the~     study product, AOBO-001, when taken by adults with symptoms of overactive bladder. AOBO-001,~     is experimental, which means that the U. S. Food and Drug Administration (FDA) has not yet~     approved it for use. AOBO-001 has been approved in China as a prescription drug product to~     treat bedwetting in children. AOBO-001 is also approved in Hong Kong as a dietary supplement~     to improve quality of life for people with urinary incontinence. AOBO-001 is a botanical~     (from a plant) product. It is prepared from the seeds of Xanthoceras sorbifolia bunge plant,~     which is a flowering tree grown in Northern China. Approximately 60 subjects who are 18 years~     of age and older are expected to participate in this study at up to 8 investigational sites.~     Each subject will complete 6 visits to the study site over a 14-week period. Subjects will~     consume 8 capsules of the assigned test product twice daily (that is, 16 capsules daily).~     Capsules will be taken with at least 6 ounces of water approximately 30 minutes before~     breakfast and 30 minutes before dinner. If a subject qualifies, he/she will be randomly (by~     chance) assigned to one of three study treatment groups. Subjects in one group will consume~     capsules containing a daily dose of 3.2 grams of AOBO-001; a second group will consume~     capsules containing a daily dose of 6.4 grams of AOBO-001; and a third group will consume~     capsules containing a placebo (no active ingredients). Subjects will have a 2 in 3 chance of~     being assigned to an active study treatment group. Neither the subject nor the study doctor~     will know to which study treatment group the subject has been assigned, but this information~     is available in case of a medical emergency. There will be a time during the study dosing~     schedule when all subjects will consume capsules containing a placebo (no active~     ingredients). Subjects will not be told when they are receiving the placebo.~   "
173431|NCT01294969|"~     To evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis~     previously treated with a topical ocular anti-allergy leukotriene-release inhibitor~     medication.~   "
173432|NCT01294956|"~     The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign~     of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.~   "
173433|NCT01294943|"~     The concern with oral infection and its systemic repercussions is old, many studies have been~     undertaken to establish this relationship more precisely. One of the areas mouth still little~     studied in this regard is the colonization of language within this universe of the oral~     microbiota colonization and how this may affect the general state of health care-dependent~     individuals.~      This research aims to evaluate the efficiency of a tongue cleaning device and its potential~     impacts on infectious patients fully or partially dependent care hospital.~      Patients admitted to intensive care units and inpatient units will be evaluated, divided into~     two groups: Study Group (SG) - Patients who receive oral hygiene using the tongue cleaning~     device, and Control Group (CG) - Patients who are cared for according to the routine of~     hospital nursing.~   "
173434|NCT01294930|"~     Patients operated for hip fractures are older and have several conditions that have negative~     influences on the perioperative and postoperative prognosis.~      Hip fractures can also be painful, which is stressful for the physiology of the patient. Many~     old patients have received to little fluid intake. They often have diuretic therapy, which~     even worsens dehydration/hypovolemia.~      Some patients have to wait several days for surgery. Several studies have shown a high degree~     of complications and an increased mortality in this patient group.~      Early preoperative optimization can improve the outcome. The available methods for~     optimization of the patient are complicated and time consuming.~      The investigators wish with this study to try new approaches to find which patients still are~     dehydrated when they come to the operation ward.~      The aim is to measure the color and density of the urine as well as to register the the~     variability in the plethysmographic curve before spinal anaesthesia.~      These results will be compared to circulatory instability during and after surgery as well as~     to postoperative complications.~   "
173435|NCT01294917|"~     Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue~     Oasys lenses.~   "
173436|NCT01294904|"~     Patients with chronic kidney disease (both men and women), especially those with terminal~     renal failure, manifest infertility. There has been demonstrated several hormonal changes in~     patients on dialysis. Increased levels of luteinizing hormone (LH) has been seen in men (12).~     In women the opposite has been reported. The number of spermatocytes is reduced and a~     disturbance in maturation has been observed.~      This project is aimed to study the influence of uremic milieu on fertility in men and women.~     The hypopituitary/hypothalamus gland axis and hormonal levels will be studied.~   "
173453|NCT01294683|"~     This study is being done to find out if tablets containing extended release (ER) niacin,~     laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin~     and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol~     and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g/40 mg is~     equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density~     lipoprotein cholesterol (LDL-C).~   "
173437|NCT01294891|"~     The purpose of this study is to examine how abnormal blood flow in the small vessels~     (microvessels) of the heart, muscle and kidney in paroxysmal nocturnal hemoglobinuria (PNH)~     or sickle cell disease leads to poor functioning of the heart and kidney. To test this~     question, the investigators will perform imaging tests (contrast ultrasound perfusion~     imaging) to look at the flow and function of these microvessels and compare this information~     to heart and kidney function. To further look at this question, patients who have PNH will be~     studied before and after starting a new drug (Soliris) that decreases damage to blood cells.~     In patients with sickle cell disease, patients will be studied at baseline (not during a pain~     crisis) and also during a pain crisis if one develops.~   "
173438|NCT01294878|"~     By hypothesising that Interstitial Cystitis is an allergic disorder of the urogenital system~     that is linked to mast-cells, current therapy with omalizumab may represent a potential non~     symptomatic strategy for the treatment of IC/BPS~   "
173439|NCT01294865|"~     The purpose of the study is to investigate the plasma levels of Soluble Urokinase Plasminogen~     Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and to determine~     whether it has a diagnostic and prognostic value in late-onset neonatal sepsis.~   "
173440|NCT01294852|"~     The purpose of this study is to determine whether the immediate bolus strategy combined with~     early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation~     compared to the administration of surfactant prophylaxis at 15 minutes after birth with early~     nCPAP in premature infants.~   "
173441|NCT01294839|"~     This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate~     the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and~     RVA) and the different conduction path (RVOTs and AV node) on cardiac dysfunction prevention.~   "
173442|NCT01294826|"~     The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with~     cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer.~   "
173443|NCT01294813|"~     Electrical Impedance Tomography (EIT)is a technique based on the injection of small currents~     and voltage measurements using electrodes on the skin surface generating cross-sectional~     images representing impedance change in a slice of the thorax. It is a radiation free,~     non-invasive and portable lung imaging technique. Impedance changes in lung ventilation are~     investigated in mechanically ventilated patients who routinely undergo bronchoscopy in~     intensive care medicine. Bronchoscopy is performed to suction secretions as well as to~     analyze the secretions to recognize inflammations and diseases. It is an essential~     intervention which causes changes in ventilation which remain for 1-2 hours. It is not~     completely investigated why these changes in ventilation remain for so long time and how they~     are distributed regionally. Therefore the purpose of this study is to investigate the change~     in pulmonary regional ventilation in patients who routinely undergo bronchoscopy to possibly~     generate ideas how to optimize the ventilation after bronchoscopy to optimize the patient´s~     treatment.~   "
173444|NCT01294800|"~     This study is to evaluate the efficacy of a range of preladenant doses compared with placebo~     in participants with moderate to severe Parkinson's disease (PD) experiencing motor~     fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by off time.~     Participants will continue to receive their stable regimen of L-dopa plus any adjunct~     medications during the study as prescribed by their physician. Several classes of adjunct~     medications may be used, including Amantadine, anticholinergics, dopa decarboxylase~     inhibitors, and dopamine agonists.~      Primary Hypothesis: At least the 10 mg twice daily dose of preladenant is superior to placebo~     as measured by the change from Baseline to Week 12 in the mean off time.~   "
173445|NCT01294787|"~     This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149)~     on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary~     Disease (COPD).~   "
173446|NCT01294774|"~     This study will assess the safety and efficacy of KRP203 in clinically active subacute~     cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard~     treatment, such as antimalarials.~   "
173447|NCT01294761|"~     The main objective of this clinical trial in randomizing HIV infected patients under good HIV~     control with tenofovir (TDF), emtricitabine (or lamivudine) plus lopinavir/ritonavir (LPV/r)~     into switching the regimen to raltegravir (RAL) with darunavir/ritonavir (DRV/r) or~     continuing the ongoing regimen to compare these two groups' estimated glomerular filtration~     rate (eGFR) is to investigate whether anti-HIV treatment that does not contain TDF or other~     reverse-transcriptase inhibitors (NTRI sparing regimen) can be protective of patients' renal~     functions and has the same virological efficacy in comparison with a standard treatment with~     TDF, or not.~   "
173448|NCT01294748|"~     The DESSOLVE II clinical trial is to assess the safety and performance of the~     sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in~     patients with symptomatic ischemic heart disease due to discrete de novo lesions in the~     native coronary arteries.~   "
173449|NCT01294735|"~     This is a non-randomized two-part study of MK-4827 given with temozolomide in participants~     with advanced cancer. In Part A of the study, the dose-limiting toxicities (DLTs) and the~     maximum tolerated dose (MTD) of MK-4827 when combined with temozolomide will be found by~     increasing the MK-4827 dose level in successive cohorts. In Part B of the study, participants~     with advanced glioblastoma multiforme and advanced melanoma will be enrolled to further~     evaluate the tolerability and efficacy of the MK-4827 + temozolomide combination.~   "
173450|NCT01294722|"~     This is an observational study to estimate the proportion of patients diagnosed with RA~     visiting a medical internist in a general hospital in Korea who are candidates for anti‐TNF α~     therapy.~   "
173451|NCT01294709|"~     This study will assess the safety of telcagepant in coronary artery disease (CAD)~     participants with stable angina during exercise treadmill testing and evaluate whether~     calcitonin gene-related peptide (CGRP) receptor antagonism by telcagepant reduces exercise~     tolerance in these participants. Primary hypothesis is that telcagepant does not~     significantly decrease exercise duration compared to placebo, as measured by a treadmill~     exercise test; that is, the true treatment difference in exercise duration (MK-0974 -~     Placebo) >= -60 seconds.~   "
173452|NCT01294696|"~     This was a study to estimate the proportion of participants with osteoarthritis of the~     knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did~     not report adequate pain relief at Baseline and to characterize their pain level over a~     12-month follow-up period.~   "
173454|NCT01294670|"~     The purpose of this study is to find out how safe and effective treatment with a new~     combination of drugs, vorinostat and etoposide, is in treating cancer. The medication~     etoposide is a standard medication used in the treatment of cancer in children. Vorinostat is~     an experimental drug which targets a protein(s) that control the way cancer cells grow and~     divide. Vorinostat is approved by the FDA in adults with certain cancers but not approved yet~     in children.~      There are two parts to this study. In the first part of this study, the phase I portion, a~     safe dose of the combination, vorinostat and etoposide. The goal of second part of this~     study, the phase II portion, is to see how effective the combination of vorinostat and~     etoposide is in treating cancer.~   "
173455|NCT01294657|"~     The goal of this research study is to learn if a motivation and problem solving (MAPS)~     program can help improve diet and levels of physical activity in African Americans who are~     overweight.~   "
173456|NCT01294644|"~     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of~     submental fat (fat below the chin).~   "
173457|NCT01294631|"~     The purpose of the study is to evaluate the effects of multiple doses of hydrochlorothiazide~     and canagliflozin on the concentrations of each drug in the blood and the concentration of~     glucose in the blood and urine in healthy adult volunteers.~   "
173458|NCT01294618|"~     The aim of this study is to demonstrate the safety and the efficacy of a combination of 2~     treatments shown to have some efficacy in Chronic Phase Chronic Myelogenous Leukemia (CP CML)~     separately, but that have never been combined to date, and this combination is expected to~     substantially increase the molecular response rates.~   "
173459|NCT01294605|"~     This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™~     (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by~     two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of~     licensed Td vaccines in adults.~   "
173460|NCT01294592|"~     Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the~     efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful~     waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic~     benign prostate hyperplasia (BPH).~      Once consented, each subject will undergo screening procedures to ensure the prostate volume~     and post void residual are within eligible range. If all entry criteria are met, subjects~     will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or~     watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation~     will be initiated when no improvement from baseline is scored using the International~     Prostate Symptom Score (version 2) (IPSS) questionnaire.~      After randomisation, the subjects return to site at one month, then every 13 weeks until two~     years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events~     (AE's) and concomitant medication monitoring and completion of the quality of life~     questionnaires are performed at each visit and the data recorded.~   "
173461|NCT01294579|"~     The purpose of this phase II open label study is to evaluate the safety and efficacy of~     ofatumumab and bendamustine followed by maintenance ofatumumab in subjects with indolent~     B-NHL who have relapsed after Rituximab treatment. A maximum of 53 subjects at least 18 years~     old with Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, or follicular~     lymphoma; Grades 1, 2 and 3a, will be enrolled (34 in Stage 1 and 19 in Stage 2). Subjects~     should have Rituximab-sensitive disease, defined as a Partial Remission (PR) or Complete~     Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following~     completion of therapy or subjects should have relapse or disease progression following~     response to prior rituximab-based therapy and with a Eastern Cooperative Oncology Group~     (ECOG) Performance status of 0 1 or 2. During the induction phase, ofatumumab 1000 mg IV on~     day 1 of each cycle (cycles 1-6) will be followed by Bendamustine 90 mg/m2 IV on days 1, 2 of~     each cycle (cycles 1-6).During the maintenance phase, subjects with a PR or CR after the~     induction phase will receive ofatumumab 1000 mg IV every 2 months for 2 years.~   "
173462|NCT01294566|"~     This study is the First Time In Human study for the motilin receptor agonist, GSK1322888.~     GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from~     the motilide compound structures. The aims of this study are to assess the safety, tolerance,~     and pharmacokinetics of single oral doses of GSK1322888 and to identify a well-tolerated and~     safe dose that will accelerate gastric emptying of a 13C stable isotope-labeled test meal in~     healthy volunteers.~      The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse~     events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.~   "
173463|NCT01294553|"~     An open label, multi-centre, non-interventional post-marketing surveillance to monitor the~     safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients~     according to the prescribing information~   "
173464|NCT01294540|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and~     healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy~     adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a~     single dose of 50 mg in healthy elderly volunteers.~   "
173465|NCT01294527|"~     The WiCS-LV system is an alternative means to providing left ventricular stimulation for~     Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety~     and performance of the WiCS-LV System in patients with indications for CRT.~   "
173466|NCT01294514|"~     The purpose of this study is to study Non-Invasive Performance evaluation of monitoring~     algorithm.~   "
173467|NCT01294501|"~     Giving medications to children can be confusing; studies have shown that caregivers make~     dosing administration errors up to 50% of the time. There are many reasons that there are so~     many errors, including the fact that dosing for children is based on their weight, liquid~     medications come in many different forms, and caregivers often give medicines using kitchen~     teaspoons and tablespoons. Caregivers who have difficulty reading have even more difficulty~     understanding medication instructions. We are developing and testing a web-based educational~     module to teach caregivers how to give medications. We are focusing on the pediatric~     emergency department because we know that this population has low literacy levels, and that~     many antibiotics are prescribed in this setting. We anticipate that those caregivers that~     view the interactive module will have increased knowledge on how to give medications once~     they get home.~   "
173470|NCT01294462|"~     The purpose of the study is to assess the efficacy (prevention of vascular events) and safety~     (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top~     of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned~     percutaneous coronary intervention (PCI).~   "
173471|NCT01294449|"~     MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the~     MADIT-CRT IDE study examining long-term mortality.~      (MADIT-CRT IDE: NCT00180271)~   "
173472|NCT01294436|"~     This is a long term, single arm, open label study to evaluate the safety and efficacy of~     dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in~     Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on~     diet and exercise or on other anti-diabetic treatment will be included in this study.~   "
173473|NCT01294423|"~     This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and~     safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who~     have inadequate glycemic control with diet and exercise.~   "
173474|NCT01294410|"~     The purpose of this study is to determine whether BMS-936557 is effective in the treatment of~     moderate to severely active ulcerative colitis in patients who have had insufficient response~     and/or intolerance to other medical therapy for ulcerative colitis~   "
173475|NCT01294397|"~     The primary objective of the study was to characterize the effects of a single dose of~     denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone~     mineral density (BMD) and rheumatoid arthritis based on area under the serum~     concentration-time curve (AUC) and maximum observed serum concentration (Cmax).~   "
173476|NCT01294384|"~     This study will investigate the safety, efficacy and acceptability of two new eye drop~     formulations compared with Refresh Tears® in patients with dry eye disease.~   "
173477|NCT01294371|"~     The purpose of this study is to assess rates of administration of add-back therapy in~     patients with endometriosis in the Russian Federation, during a 6-month course of~     gonadoliberin agonist leuprorelin 3.75 mg.~   "
173478|NCT01294358|"~     Background:~      - Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the~     tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink~     some of the tumor, but even with chemotherapy only about 25 percent of patients will live for~     1 year following diagnosis. Several preliminary studies have shown that it is safe to give~     chemotherapy directly into the pancreas in the area of the tumor, and that giving gemcitabine~     over a longer period increases the amount of drug that is available to the tumor. Researchers~     are interested in studying whether giving the approved pancreatic cancer chemotherapy drug~     gemcitabine directly into the pancreas in the area of the cancer and at a slow rate of~     infusion is a safe and effective treatment.~      Objectives:~      - To test the safety and effectiveness of administering gemcitabine directly to a pancreatic~     tumor at a slow rate of infusion.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with pancreatic cancer that is~     currently too large to be removed surgically but has not yet spread to other organs.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and imaging studies.~        -  Participants will undergo pancreatic angiography and embolization, during which a~          catheter will be threaded into the blood vessels near the pancreas and a contrast dye~          will be used to show the blood vessels supplying the tumor. These blood vessels will~          then be surgically closed off.~        -  After the embolization, gemcitabine will be given as an infusion into the area around~          the tumor over 24 hours.~        -  Participants will return to the clinical center every 2 weeks after the first infusion~          for additional infusions of gemcitabine, using the same procedures as above.~          Participants will be monitored with frequent blood tests and imaging studies.~        -  Two weeks after the fourth treatment (course 1), participants will have more imaging~          studies, a physical examination, and blood tests. If the tumor is shrinking,~          participants will have two more courses of treatment (eight more infusions of~          gemcitabine).~        -  Participants will have followup visits every 3 months for 2 years following the last~          treatment and then every 6 months.~   "
173479|NCT01294345|"~     Background:~      - Congenital malformations, sometimes called birth defects, occur because of a difference in~     early human development. There are many different types of congenital malformations, and some~     of these can be caused by changes in genetic material. Researchers are interested in studying~     individuals with these congenital malformations to better understand the causes and the~     effects of certain congenital malformations.~      Objectives:~        -  To understand more about what causes congenital malformations that arise in early human~          development.~        -  To learn if genetic causes can be found to explain why a person has a congenital~          malformation.~      Eligibility:~      - Individuals who have been diagnosed with a congenital malformation.~      Design:~        -  Participants will be seen at the National Institutes of Health for a series of visits~          over 3 to 4 days. Participants will be asked to provide copies of past medical records~          and test results for review, and will be asked questions about pregnancy/prenatal~          history, birth, newborn, medical, developmental, and family history.~        -  Parents or siblings of participants may also be asked to provide information for~          research purposes.~        -  Participants may have additional medical evaluations as part of this study, including~          any of the following tests:~        -  Physical examinations~        -  Other consultations as clinically indicated~        -  Blood samples for genetic testing~        -  Tissue biopsy for genetic testing~        -  Photographs of affected areas, such as front and side views of the face and other body~          parts that may be involved in a congenital malformation, like the hands and feet.~        -  Other tests as indicated by a specific malformation, such as organ ultrasounds.~        -  No additional invasive testing, testing requiring sedation, or testing involving~          radiation is planned for this protocol. These tests, if performed, would involve a~          separate consent....~   "
173480|NCT01294332|"~     Background:~      - Many people who have traumatic brain injury (TBI) have low levels of physical fitness. Low~     physical fitness causes severe fatigue that reduces the ability to perform routine daily~     activities, and may also cause increased depression, anxiety, or sadness. Aerobic exercise,~     such as treadmill walking or running, improves physical fitness in most people and may also~     decrease fatigue and improve mood. However, more information is needed to determine if~     exercise improves these conditions in people who have TBI.~      Objectives:~      - To examine the effect of an aerobic treadmill walking exercise program on physical fitness,~     fatigue, and mood in people with TBI.~      Eligibility:~      - Individuals between 21 and 45 years of age who had a nonpenetrating traumatic brain injury~     at least 6 months before participating; able to understand oral and written English language,~     give informed consent and sign a consent form; are physically inactive (including activities~     related to both job and recreation); and are able to stand and walk on a treadmill safely~     without help.~      Design:~        -  This study requires 4 testing visits and 36 exercise visits over 14 weeks.~        -  The first and third testing visits will last about 4 hours and the second and final~          testing visits will take about 2 hours.~        -  Testing visits will consist of a medical history and physical examination, completion of~          questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall~          quality of life), tests of thinking and a treadmill exercise test.~        -  Participants will have treadmill exercise training 3 days per week for 12 weeks. Each~          session includes a check-in, warm-up, treadmill walking at the training heart rate, and~          cool-down. Thirty-two of the sessions will last for about 1 hour, and four of the~          sessions will include questionnaires to fill out and will last about one-and-a-half~          hours.~        -  After completing the exercise training program, participants will have a final testing~          visit to complete the questionnaires (about fatigue, daily physical activity, sleep~          quality, mood, and overall quality of life), tests of thinking and a treadmill exercise~          test.~   "
173481|NCT01294319|"~     This study proposes to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in~     younger endurance trained and sedentary men, and in older sedentary men.~   "
173482|NCT01294306|"~     This phase II trial studies the side effects and how well Akt inhibitor MK2206 (MK2206) and~     erlotinib hydrochloride works in treating patients with advanced non-small cell lung cancer~     who have progressed after previous response to erlotinib hydrochloride therapy. MK2206 and~     erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
173506|NCT01293994|"~     The investigators will be collecting saliva DNA samples from chronic back pain patients. The~     investigators hope to find candidate genes associated with response to opioid medication by~     correlating molecular genetics data with pain measurement and opioid responsiveness data~     including opioid hyperalgesia and opioid analgesic tolerance.~   "
173483|NCT01294293|"~     This phase I trial is studying the side effects and best dose of TLR8 agonist VTX-2337 and~     pegylated liposomal doxorubicin hydrochloride in treating patients with recurrent or~     persistent ovarian epithelial, fallopian tube, or peritoneal cavity cancer. Biological~     therapies, such as TLR8 agonist VTX-2337, may stimulate the immune system in different ways~     and stop tumor cells from growing. Drugs used in chemotherapy, such as pegylated liposomal~     doxorubicin hydrochloride and paclitaxel, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving TLR8 agonist~     VTX-2337 together with pegylated liposomal doxorubicin hydrochloride or paclitaxel may kill~     more tumor cells.~   "
173484|NCT01294280|"~     This research trial studies prognostic and predictive markers in patients with early stage~     non-small cell lung cancer receiving chemotherapy. Prognostic markers are patient or tumor~     factors that predict patient survival independent of treatment. Predictive markers are~     factors that may influence and predict the outcome of treatment in terms of either response~     or survival benefit. Collecting and storing samples of tissue from patients with cancer to~     study in the laboratory may help doctors learn more about cancer and identify biomarkers~     related to cancer.~   "
173485|NCT01294267|"~     The purpose of this research study is to evaluate the safety and feasibility of the Impella~     2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia~     in the setting of Ventricular dysfunction.~   "
173486|NCT01294254|"~     In this study the wound reepithelialization of that part of the skin graft donor site, which~     is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist~     wound healing dressing alone will be investigated.~   "
173487|NCT01294241|"~     The purpose of this study was to compare intra-individually the reepithelialization of skin~     lesion(s) in inherited Epidermolysis bullosa (either 1 wound ≥10 cm2 and ≤200 cm2 in size~     divided in 2 equal halves or 2 comparable wounds of ≥5 cm2 each) treated with Oleogel-S10 and~     non-adhesive wound dressing versus non-adhesive wound dressing only.~   "
173488|NCT01294228|"~     This is a multi-center, prospective, observational study of patients that are admitted to the~     intensive care unit (ICU). This study does not include any treatment or intervention and it~     is considered Nonsignificant Risk.~   "
173489|NCT01294215|"~     This is a clinical study evaluating the safety and efficacy of long term administration of~     oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in~     patients with essential hypertension who are not at target blood pressure by the combination~     of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.~   "
173490|NCT01294202|"~     The purpose of this study is to investigate if an investigational drug called AT13387 is~     active against Gastrointestinal Stromal Tumor (GIST) that is resistant to other treatments,~     and to understand more about the safety of AT13387.~      Most subjects in the study will receive AT13387 along with another drug called imatinib~     (Gleevec). Imatinib is a standard (approved) drug for treating patients with GIST. Some~     patients may receive AT13387 on its own. As a result, we shall begin to understand the~     effects of AT13387 given on its own and when combined with imatinib.We shall also find out~     more about the side-effects of AT13387, and more about how the body breaks down (metabolizes)~     AT13387.~   "
173491|NCT01294189|"~     Description of the decision making process as well as the practices of end of life care in an~     ICU of a German university hospital during the period when changes of German legislation~     occurred.~   "
173492|NCT01294176|"~     The purpose of this study is to determine if oral lipoic acid can safely help relieve~     permanent optic nerve injury in patients diagnosed with acute optic neuritis. It will also~     explore how the body absorbs and breaks down the study drug, and what effects it has on the~     immune system.~   "
173493|NCT01294163|"~     Xenon is a gaseous anaesthetic agent registered in several European countries. It has been~     administered safely during cardiac surgery in pilot studies. In animal studies, xenon~     decreases the size of experimental myocardial infarction.~      This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous~     anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery~     conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before~     and after extracorporeal circulation. Propofol will be administered during extracorporeal~     circulation in the three groups of patients.~      The study will compare the postoperative myocardial damage observed 24 hours after surgery~     from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The~     main hypothesis is that the myocardial damage observed after xenon administration will not be~     superior to the damage observed after sevoflurane administration (non-inferiority). The~     second hypothesis is that the myocardial damage observed after xenon administration will be~     inferior to the damage observed after total intravenous anaesthesia.~   "
173494|NCT01294150|"~     The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System~     when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will~     be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and~     safety will be reviewed based on pertinent adverse events.~   "
173495|NCT01294137|"~     Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be~     different than in the youngest people, and its consequences might be severe and atypical~     (falls, functional and cognitive decline).~      Today, there is no specific tool to detect sleep apnea in the elderly. The goal of this study~     is to evaluate the accuracy of oximetry for detection of respiratory disturbances in sleep~     apnea in the hospitalized elderly.~   "
173507|NCT01293981|"~     The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor~     Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.~   "
173508|NCT01293968|"~     The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and~     Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)~   "
173509|NCT01293955|"~     -  A Pilot study~        -  Randomized and Double-blinded~        -  Placebo controlled~        -  In 2 parallel group (JOINS 200mg:Placebo = 1:1)~        -  Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional~          follow-up assessment up to 24 months)~        -  Provide rescue medicine throughout whole clinical trial period.~   "
177675|NCT01239433|"~     Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this~     study pressure changes are examined in a mechanical lung model and in a population of ICU~     patients on mechanical ventilation.~   "
173496|NCT01294124|"~     The investigators hypothesize that individual differences exist in resting-state cortical~     attention, control, sensory, and emotion networks prior to noise exposure and these~     differences predispose some to the development of bothersome tinnitus. Furthermore, the~     investigators hypothesize that these changes in functional connectivity of these vulnerable~     systems after noise exposure are responsible for tinnitus. The proposed study will use a~     case-control cohort study design. Cases will be those soldiers who develop tinnitus and~     controls will be those who do not. This will be the first prospective study of tinnitus and~     will provide important information about the neurobiology of tinnitus.~      If a cortical neural network etiology for bothersome tinnitus is confirmed, it will be an~     astounding, powerful, paradigm shifting model for the diagnosis, prevention and, most~     importantly, treatment of tinnitus. Furthermore, if a battery of neurocognitive tests can~     identify soldiers at risk for the development of tinnitus then appropriate primary prevention~     strategies can be introduced.~      There are three Specific Aims to this project.~      Specific Aim 1. To determine if soldiers who develop tinnitus display pre-deployment~     differences in a set of physical, functional, cognitive, vulnerability, perpetuating factors,~     pre-deployment neurocognitive scores, or neuroimaging features compared to soldiers who do~     not develop tinnitus (control group).~      Specific Aim 2. To determine if particular scores on neurocognitive tests or neuroimaging~     features of functional/structural connectivity networks are associated with the development~     of tinnitus.~      Specific Aim 3. To identify a set of pre-deployment physical, functional, cognitive,~     vulnerability, and perpetuating factors, neurocognitive responses, and neuroimaging features~     that are associated with the development of tinnitus.~      The investigators plan to recruit 200 soldiers, between the ages of 18 and 30 years who do~     not have hearing loss or tinnitus and have never been deployed to military theater. The~     soldier participants will undergo a variety of tests before and after deployment, which will~     include a hearing test, neurocognitive tests (i.e., brain function tests), and a variety of~     novel radiologic imaging studies of the brain. One of these novel radiologic imaging studies~     is functional connectivity Magnetic Resonance Imaging, a proven methodology that monitors~     changes in brain activity and connections based on blood flow between different brain areas~     and levels of consumption of oxygen. This information is used to describe the condition of~     important neural networks responsible for such things as attention, mood, sensation, vision,~     hearing, and introspection or self-contemplation.~   "
173497|NCT01294111|"~     Physical activity is recommended in the treatment of heart failure. Elderly people demand~     various forms of physical activity. Tai chi has shown to be an appreciated form of physical~     activity among elderly, although there is a lack of studies focusing people aged 70 years and~     older.~      The overall goal with the project is to find a form of physical activity that is safe and~     free from side effects, suitable for elderly people with chronic heart failure. The~     hypothesis is that for patients participating in tai chi training during three months the~     degree of self rated fatigue will be reduced and health-related quality of life will~     increase, compared with a control group receiving ordinary care. The primary aim is to study~     the effect of tai chi training on fatigue and health-related quality of life. A second aim is~     to study effects on physical function and levels of brain natriuretic peptide (BNP) in blood~     plasma. A tertiary aim is to describe the experience of participating in tai chi training.~      A mixed methods study is conducted. Fortyfive patients with a verified diagnosis of heart~     failure in the age of 70 years or older, who experience fatigue according to the Multi~     Fatigue Inventory (MFI-20), was randomized to intervention or control group. Three groups~     with 8-9 participants each completed a tai chi training programme twice-weekly for 16 weeks.~     Data was collected at baseline, directly after the 16 weeks of training, and 6 and 12 months~     thereafter. The programme is worked out by an expert in Chinese traditional medicine to suit~     elderly people with chronic heart failure, and the classes were led by experienced leaders.~     Before the start of the study a small pilot study was conducted to test the feasibility of~     the programme. A group of seven patients completed the programme for eight weeks without any~     problems.~      If tai chi has a good effect on fatigue, health-related quality of life and physical~     function, this form of physical activity can be a valuable complement to other medical~     treatment. Tai chi has a potential to be offered to many patients to a relatively low cost.~     It can be practiced in groups or in private, and also through internet connection.~   "
173498|NCT01294098|"~     The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve~     blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a~     pediatric population.~   "
173499|NCT01294085|"~     To assess the difference of prognosis between unresectable and recurrent biliary tract cancer~     and evaluate prognostic factors.~   "
173500|NCT01294072|"~     This clinical trial will investigate the ability of plant exosomes to more effectively~     deliver curcumin to normal colon tissue and colon tumors. Curcumin is the yellow pigment of~     turmeric, a natural product with diverse biological activities. Exosomes are small~     endosome-derived vesicles (50-100 nanometers [nm] in size). Previous clinical trials~     conducted with oral curcumin have demonstrated only limited bioavailability even at very high~     doses of 8-12 grams per day. This trial plans to address this problem of curcumin delivery by~     using plant exosomes to deliver the drug to colon tumors and normal colon tissue.~   "
173501|NCT01294059|"~     Fibromyalgia syndrome (FM) shares many symptoms common to chronic neuropathic pain, including~     the characteristic hyperalgesia of the skin (thermal, mechanical) and muscles (mechanical)~     found in almost all FM patients. Milnacipran, a balance norepinephrine-serotonin re-uptake~     inhibitor, has been found to reduce pain and improve physical function of FM patients.~     However, little is known about the pain mechanisms that are affected by this medication.~     Therefore, the investigator wants to determine the efficacy of milnacipran in reducing pain~     as well as mechanical and thermal hyperalgesia of FM patients during a randomized,~     double-blind, placebo controlled trial. Because the investigator expects anti-hyperalgesic~     effects to coincide or precede with effects on clinical FM pain the proposed duration for~     this trial is 6 weeks.~   "
173502|NCT01294046|"~     This investigation will gather information about a procedure called sphenopalatine ganglion~     (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who~     suffer migraine headaches which may result in chronic severe disability. The SPG is a small~     collection of nerve cells in the head, and is located near the base of the nose on either~     side. Participation involves the surgical implantation of an electrode (small electrical~     conductor) over the sphenopalatine ganglion. The electrode is connected to a stimulator which~     will enable treatment for migraine headaches. Tiny electrical current is delivered to the~     stimulator device by an internal pulse generator implanted in the area at the top of the~     chest, to stop the migraine headaches. The implant system will be controlled with a wireless~     remote provided after the implant procedure.~      Participation will record headache diaries throughout the study, which will last~     approximately 8½ months, and a yearly visit annually for five years.~   "
173503|NCT01294033|"~     Maximal consumption of oxygen (VO2max) during exercise is used in patients with chronic~     obstructive pulmonary disease (COPD) to stratify perioperative risk. However, the impact of~     supplemental oxygen to prevent hypoxemia during exercise on maximal oxygen consumption and~     other ventilatory parameters during maximal exercise in the resting normoxic Chronic~     Obstructive Pulmonary Disease population is poorly defined. The investigators performed a~     randomized controlled trial in patients with COPD who underwent cardiopulmonary exercise~     tests on room air and supplemental oxygen. The investigators compared maximal oxygen~     consumption and other ventilatory parameters in each individual subject under the two~     conditions.~   "
173504|NCT01294020|"~     Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to~     Advagraf® immunosuppression to compare exposure and follow for safety and efficacy over one~     year.~   "
173505|NCT01294007|"~     The purpose of this study is to evaluate the rate and quality of fusion of PureGen~     Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral~     fusion (PLF) procedures.~   "
173937|NCT01288391|"~     This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety~     and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses~     of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.~   "
173510|NCT01293942|"~     The percentage of patients with defined unresectable metastatic disease who will benefit from~     a first-line treatment enabling secondary complete metastasectomy is unknown but limited.~     Definition of optimized treatment algorithms is difficult due to very inhomogeneous patient~     populations.~      This open label, multicentre Phase II study primarily aims to assess the resection rate~     achievable in a selected patient population with initially unresectable metastatic disease~     limited to the liver only in order to evaluate feasibility, safety and efficacy with regards~     to secondary resection of hepatic lesions in these patients.~      The trial aims to enrol only patients meeting defined criteria of unresectability with~     regards to their hepatic lesions and will exclude patients with extrahepatic lesions in order~     to examine the most appropriate, highly active treatment regimen for this group of~     unresectable patients with the highest probability of a successful secondary metastasectomy~     with curative intent. The trial will be conducted in highly specialized centres with a track~     record of successful interdisciplinary treatment approaches in the field of metastatic~     colorectal cancer to allow the precise assessment of the peri-operative safety parameters as~     well as an evaluation of the surgical treatment approaches.~      The IXO regimen selected for this study has shown in a phase I/II study promising efficacy~     and a favourable safety profile. Bevacizumab has demonstrated a significant survival benefit~     in combination with chemotherapy in metastatic colorectal cancer. Therefore the study will~     allow evaluation of its potential benefit in combination with the two most active current~     chemotherapy regimens in the first-line and post-operative treatment setting.~   "
173511|NCT01293929|"~     Chemerin is a novel adipokine that might provide a link between chronic inflammation and~     obesity. Pulse wave velocity(PWV) is a useful method for examining arterial stiffness,~     meaning early-stage atherosclerosis. Therefore, in the present study, the investigators~     examined the relationship between circulating chemerin and arterial stiffness measured using~     PWV in obese persons.~   "
173512|NCT01293916|"~     Prospective randomized controlled trial comparing use of single leg spica with double leg~     spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years~     old.~   "
173513|NCT01293903|"~     The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely~     associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin~     capsule, a Chinese medicine, could enhance heart function in chronic heart failure and~     regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore~     the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in~     patients with DCM, patients were recruited, anti-heart autoantibodies and some representative~     cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of~     heart function improvement was compared between Qiliqiangxin capsule and placebo under the~     standard treatment of DCM.~   "
173514|NCT01293890|"~     Chronic Obstructive Pulmonary Disease (COPD) represents one of the most challenging chronic~     diseases of the 21st century: it is expected to be the fourth leading cause of death by 2030.~     COPD is characterized by pulmonary and extra-pulmonary systemic manifestations caused by~     partly irreversible expiratory airflow obstruction. The cornerstone of COPD management is the~     prescription of single or combined inhalation therapy, such as short- and long-acting~     bronchodilators, inhaled corticosteroids to possibly prevent disease progression, preserve~     lung function, relieve respiratory symptoms and prevent or treat exacerbations. Given the~     complex and lifelong treatment, one can expect that adherence to the prescribed inhalation~     therapy is not self-evident. Adherence can be defined as the the extent to which a person's~     behaviour (taking medications, following a recommended diet and/or executing life-style~     changes) corresponds with the agreed recommendations of a health care provider. Inhaled~     medications have an additional complexity in that patients who intend to be adherent may be~     take the inhaled medication incorrectly, prohibiting proper therapeutic action. Taking less~     than the prescribed amount of medication, missing doses or stopping treatment for brief or~     extended periods will put the patient at risk for suboptimal disease control. Hence, the~     effectiveness will largely depend on the patient's ability to manage their disease adequately~     in daily life.~      Using electronic monitoring, 3 studies in COPD found a prevalence of medication non-adherence~     of 51% which was worse than the average prevalence of 29% (range 3-66%) found across diseases~     such as hypertension, cancer, epilepsia, infections and HIV.~      The existing evidence on risk factors for nonadherence in COPD is mostly anecdotic and not~     guided by behavioral models. According to the integrated model of behavioral prediction~     (IMBP), barriers, skills and ability and intention are the most important drivers of~     adherence (i.e. medication adherence).~      The aims of the study are the following:~        -  To prospectively investigate the impact of medication nonadherence on time to~          exacerbation (primary end-point) and exacerbation rate, FEV1, hospitalization rate and~          duration, and quality of life (secondary end-points) at 1 year follow-up using~          electronic monitoring~        -  To investigate risk factors for medication nonadherence, using the Integrated Model of~          Behavioral Prediction as a theoretical framework~        -  To determine the diagnostic accuracy of different measures of medication nonadherence~          (i.e. pill count, self-report and physician rating) relative to electronic monitoring.~        -  To investigate the prevalence of nonadherence to other aspects of the therapeutic~          regimen, i.e. the use of concomitant medications, smoking cessation, alcohol use,~          physical activity, attendance to rehabilitation sessions and dietary adherence, their~          interrelations, and impact (alone and in combination) on time to first exacerbation.~        -  To investigate the interrelations in adherence to the various components of the~          therapeutic regimen.~        -  To investigate the impact of nonadherence to the other components of the therapeutic~          regimen (alone and in combination) on clinical outcomes (i.e. time to exacerbation,~          exacerbation rate/PPY, FEV1, hospitalization rate and duration, and quality of life at 1~          year follow-up.~   "
173515|NCT01293877|"~     The study must be performed in 100 patients suffering from morbid obesity, the procedure will~     be performed under general anesthesia doing two or three layers of suture to achieves gastric~     imbrication until transform the stomach to a sleeve. The patients will be followed during the~     time for 6 month, 1 year, two years and 5 years.~   "
173516|NCT01293864|"~     The object of this study is to analyze fresh human skin samples using several up-to-date~     technologies to get parameters on the mechanical, biochemical and structural distribution of~     the main components of the capillary-tissue unit.~      Our working hypothesis is that both structural components of the dermis are not evenly~     distributed along parallel planes. The investigators further hypothesize the the distribution~     patterns determine functional and mechanical differences along dermal layers.~   "
173517|NCT01293851|"~     Background:~      - Docetaxel, the most commonly used drug for the treatment of invasive breast cancer, has~     been shown to prolong the lives of women with breast cancer and prevent the cancer from~     spreading or returning. However, docetaxel is known to cause nerve damage, including~     numbness, tingling, and pain, in 50 to 90 percent of breast cancer patients. This nerve~     damage is called peripheral neuropathy, and can be so severe that treatment with docetaxel~     may need to be stopped. Researchers are interested in studying docetaxel-related nerve damage~     to determine whether certain genetic factors may predispose women to developing this~     condition, and to more closely investigate the specific effects of docetaxel on the nervous~     system~      Objectives:~      - To examine nerve damage in women with breast cancer who are being treated with docetaxel.~      Eligibility:~      - Women at least 18 years of age who have been diagnosed with invasive breast cancer and are~     scheduled to have docetaxel treatment.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests and imaging studies.~        -  This study requires seven visits, one before the start of chemotherapy and six after the~          scheduled treatment visits. Study procedures at each visit will take 30 to 45 minutes~          and will be done in parallel with scheduled chemotherapy visits.~        -  At the first visit, participants will provide blood samples; complete questionnaires to~          rate and describe any existing pain, numbness, or tingling in hands and feet before the~          start of chemotherapy; have nerve conduction tests; and have a skin biopsy.~        -  At each visit following docetaxel treatment, participants will complete questionnaires~          to rate and describe any pain, numbness, or tingling during the course of chemotherapy.~          Participants will provide blood samples at every visit and have nerve conduction tests~          during the second, fourth, and sixth visits. Participants will also have a second skin~          biopsy, either from a site that appears to be experiencing nerve damage or (for those~          who are not developing nerve damage symptoms) from a site near the first biopsy~          location.~   "
173518|NCT01293838|"~     The primary objective is to examine whether Cipralex® is effective and safe in the treatment~     of anxiety disorders in youth. The secondary objective is to identify changes in arousal and~     stress response from pre- to post-treatment with Cipralex® in youth with anxiety disorders.~   "
173519|NCT01293825|"~     Psychotropic-related weight gain is a common concern among patients with bipolar disorder~     (BD). This concern affects an individual's satisfaction with treatment and may lead to~     reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns~     while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA~     approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight~     gain compared to some alternative BD maintenance treatments. The proposed project will~     evaluate how switching to ziprasidone may affect patient adherence, drug attitudes,~     satisfaction with care and clinical outcomes (psychiatric symptoms, functional status,~     weight) among BD patients concerned with weight gain.~   "
173528|NCT01293708|"~     The purpose of this study is to understand the realities, expectations and attitudes of~     patients 80+ and their families about the use of life-sustaining technology, and to document~     the patient outcomes and family experiences associated with surviving and not surviving~     critical illness. Specifically in this project the investigators will determine the real~     outcomes of critical illness experienced by octogenarians.~   "
173681|NCT01291719|"~     The purpose of this study is to study the use of a counterbalancing system of glucose and~     insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can~     produce tight glycemic control without hypoglycemia; study to develop a closed loop for use~     in intensive care units and surgery~   "
173520|NCT01293812|"~     Background : Previous studies suggest that early recognition and treatment of pain among~     children is important for their cognitive development and their future response to pain~     throughout their life. Oral sweet solutions have been accepted as effective pain reducing~     agents for procedures in the neonatal population. To date, there have been a limited number~     of published clinical trials in an emergency setting studying this type of intervention among~     infants and these studies have shown conflicting results.~      Objective : To compare the efficacy of an oral sucrose solution versus placebo in reducing~     pain in children 1 to 3 months of age during venipuncture in the Emergency Department (ED).~      Methods : A single-center, randomized, double-blind, placebo controlled clinical trial will~     be conducted in an urban tertiary care pediatric university-affiliated hospital ED. The study~     population is all infants from 1 to 3 months of age requiring venipuncture as part of their~     planned ED management. Study participants will be randomly allocated to receive 2 ml of a 88%~     sucrose solution or 2 ml of a placebo solution. The primary outcome measure is the difference~     in pain levels during the venipuncture in the study population as assessed by the Face, Legs,~     Activity, Cry and Consolability Pain Scale (FLACC). Secondary outcome measures will evaluate~     differences of pain levels using the Neonatal Infant Pain Scale (NIPS). Crying time and~     changes in heart rate during the procedure will be recorded. Side effects and adverse events~     will also be noted. The investigators will also measure the number of successful~     venipunctures at the first attempt. Based on previously reported data, using an alpha value~     of 0,05, a power of 90% and using a 2-point difference in mean FLACC scores as clinically~     significant difference, approximately 41 patients per group will be needed considering a~     drop-off value of 25%. Patients' characteristics and outcomes will be compared using the~     Pearson Chi-square test for categorical variables and the Student's T test for continuous~     variables. A intention to treat analysis will be performed.~   "
173521|NCT01293799|"~     BACKGROUND: Peritonitis remains a significant problem in peritoneal dialysis. It is the~     leading cause of technique failure, and contributes to mortality. The incidence is highest~     during the first year of treatment. Non-compliance with the Peritoneal Dialysis (PD) protocol~     is shown to be an important risk factor for peritonitis. Reinforcement of knowledge and~     ability to perform PD therefore appears to be a possible way to reduce the incidence of~     peritonitis. This will be studied in The PEritonitis Prevention Study (PEPS).~      METHODS: The objective of this randomized, multi-centre investigation,which will include 750~     new PD patients who can perform (PD) without assistance, is to evaluate if regular retraining~     can reduce the incidence of peritonitis, the technique-failure rate, and the hospitalisation~     days due to peritonitis compared with regular follow-up regimen. Patients in the intervention~     group will tested by a PD-technique test and a questionnaire at regular intervals after~     PD-start and after every peritonitis episode with focus on infection prophylaxis. If needed,~     they will be retrained. The control group will be treated according to the routine of the~     center.~      The study is ongoing in Denmark, Norway, Sweden, Finland, Estonia, Latvia, the Netherlands,~     and the UK. The study will go on for 6 years.~   "
173522|NCT01293786|"~     Both Kidney transplantation (KT) and Chronic Kidney Disease (CKD) patients have reduced~     kidney function. Low serum magnesium is more prevalent in KT recipients. The present study~     examines the difference in vascular calcification between KT and CKD and its association with~     serum magnesium.~   "
173523|NCT01293773|"~     Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the~     prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578-~     versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de~     novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.~      Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary~     End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death,~     myocardial infarction and repeated lesion revascularization within 12 months.~      Secondary End-Points: 1) impact of glucose level during the first three months following the~     procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization;~     2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (> 12~     months) of dual antiplatelet therapy~   "
173524|NCT01293760|"~     The purpose of this study is to determine, in a pilot setting, if this study is feasible in~     terms of recruitment, willingness to be randomized, provision of contraceptive methods, and~     follow-up. The investigators hypothesize that this pilot study will be feasible in terms of~     recruitment, provision of care, and follow-up.~      The study will be a pilot randomized controlled trial comparing outcomes of immediate~     post-placental insertion of the Copper T 380A (Group 1) to outcomes of interval insertion of~     the Copper T 380A performed 6 weeks after delivery (Group 2) for patients undergoing~     scheduled cesarean delivery at Mulago Hospital in Kampala, Uganda. This study will not be~     powered to detect a difference, but rather the investigators will enroll all eligible and~     interested women during the three-month enrollment period. Potential participants who do not~     choose an IUD or who choose not to participate will be offered an anonymous opt-out survey.~   "
173525|NCT01293747|"~     Phase I pharmacokinetic study~      Main objective:~      To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone~     on each of the formulations studied, after multiple-dose administration~      Study design:~      Randomized, controlled, open-label, parallel, pharmacokinetic study~      Sites: 1~      Subjects: 30 postmenopausal women~   "
173526|NCT01293734|"~     Bronchial asthma is a common disease and frequently encountered disease of respiratory~     apparatus. It has very complex mechanism and multiple inducing factors. This study will focus~     on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal~     and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice.~     The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial~     asthma, and provide an effective therapy for this disease.~   "
173527|NCT01293721|"~     Osteoporotic hip fracture is common in elderly. As a result of aging population in Hong Kong,~     the total number of hip fracture cases is anticipated to increase substantially in the~     future, and therefore draw more resources in hospitals and healthcare cost. Osteoporotic hip~     fracture usually causes severe pain and takes long time (4-8months) to recover due to~     impaired healing capability in osteoporotic bones and limited mobility. Consequently, the~     patients will recover very slowly as a result of low physical activities to provide~     inadequate mechanical stimulation. It is also known that mechanical, vascular and biological~     factors are the keys for fracture healing.~      Low-magnitude, high-frequency vibration (LMHFV) treatment is a biophysical intervention to~     provide whole-body vibration signals for mechanical stimulation, which has been proven to be~     good in enhancing bone and muscle performance, as well as blood circulation. Our previous~     study of LMHFV on femoral fracture in rats showed acceleration of fracture healing, resulted~     from enhanced callus formation and maturation. Application of LMHFV on osteoporotic fractures~     could shorten the period of complete callus bridging by 30%. Our clinical trial on normal~     elderly also demonstrated improved muscle performance with good compliance, which is also a~     critical factor for fracture healing.~      In this study, the investigators therefore hypothesize that LMHFV can enhance hip fracture~     healing by enhancing fracture impaction, maintaining bone mineral density, enhancing muscle~     recovery, thus improving implant mechanical stability and rehabilitation in elderly patients.~     The hip fracture elderly patient will be recruited and randomized into control or treatment~     group. They will be assessed on the fracture healing at fixed time point. The findings of~     this study will provide very useful scientific data to support the application of LMHFV for~     hip fracture patients.The ultimate goal is to enhance the fracture healing and rehabilitation~     in elderly patients.~   "
173529|NCT01293695|"~     This study is designed to determine the effect of a Hypnosis Intervention on reducing hot~     flash frequency (perceived impact vs. physiologically measured impact), severity and daily~     interference in post-menopausal women. It is felt that the Hypnosis Intervention will result~     in significantly lower hot flash frequency, severity and daily interference scores (perceived~     impact vs. physiologically measured impact) versus Structured-Attention Control.~   "
173530|NCT01293682|"~     This research will examine the effectiveness of calcitriol in treating bone loss in women who~     are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to~     take part in this study. The investigators don't know if bone loss in breast cancer survivors~     should be treated differently than bone loss in other women.~   "
173531|NCT01293669|"~     TC-6987 is a selective nicotinic α-7 receptor ligand (open channel stabilizer) that has~     demonstrated potent anti-inflammatory/antioxidant properties in animal models. Following the~     oral administration of a 1mg/kg dose of TC-6987 to diabetic mice (db/db mouse) for 7 weeks,~     numerous metabolic improvements were observed. Specifically, plasma glucose and triglyceride~     concentrations declined by approximately 30%; Hb1Ac was reduced by nearly 50%; and TNF-α~     declined more than 60% relative to control db/db mice Therefore, it appears that TC-6987~     could prove beneficial in reducing elevated glucose concentrations in diabetic patients as~     well as in ameliorating organ damage associated with inflammation, oxidative stress and~     hyperglycemia.~   "
173532|NCT01293656|"~     This study is being done to assess the clinical course and treatment options for Crohn's~     Disease (CD) and ulcerative colitis (UC) in the populations of Eastern Europe, Middle East,~     and North Africa.~   "
173533|NCT01293643|"~     This is a study to compare the safety and efficacy of the use of a intravaginal ovule~     containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream~     containing a combination Tetracycline and Amphotericin B for the treatment of bacterial~     vaginosis and/or mixed or isolated vaginal candidiasis.~   "
173534|NCT01293630|"~     The primary objective of the study is to determine the maximum tolerated dose (MTD) based on~     the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of~     ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients~     with advanced solid tumors.~      Secondary Objectives:~        -  To assess the overall safety profiles of the combination therapy~        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR~          258063, paclitaxel, and carboplatin when used in combination~        -  To document the objective tumor response~   "
173535|NCT01293617|"~     Berry components have been shown to influence cancer processes in cell culture studies. The~     investigators will conduct a study to investigate if blackberries influence the same cancer~     processes in a human feeding study.~   "
173536|NCT01293604|"~     The objectives of this study are the following: 1) to determine the effect of daily~     consumption of whole grain barley for six week on risk factors of cardiovascular disease~     compared to a diet low in whole grains, and 2) to compare the effects of daily consumption of~     whole grain barley to those of whole grain oats for six weeks to determine if the response to~     these two grains is different.~   "
173537|NCT01293591|"~     This study is being done to study the healthful benefits of eating garlic. Previous studies~     suggest that garlic may help prevent cancer. The investigators are recruiting healthy~     volunteers to participate in a study to determine the ways in which eating garlic may reduce~     cancer risk.~   "
173538|NCT01293578|"~     The goal of this study is to test the relative merits of a decision aid for diabetes~     medications that we have developed - Diabetes Medication Choice Cards- versus usual care in~     translating comparative effectiveness research (CER) into real world clinics. This study will~     involve about 20 primary care practice sites affiliated with Mayo Health System, Park~     Nicollet, or Hennepin County Medical Center. There will be no recruiting done at the Mayo~     Clinic.~   "
173539|NCT01293565|"~     The overall purpose of this study is to learn more about Hypohidrotic Ectodermal Dysplasia~     (HED) and to help in identifying treatment opportunities. Several evaluations will be~     conducted in this study: 1) the number of skin sweat glands you have and their ability to~     produce sweat; 2) your ability to grow hair; 3) the structure of your face compared to faces~     of people affected by HED; 4) molds of your teeth to see if and how they are different than~     people affected by HED.~   "
173540|NCT01293552|"~     The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of~     ANT-1207 in the treatment of acne.~   "
173541|NCT01293539|"~     The purpose of this study is to show that chemotherapy delivered directly through the artery~     supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective~     treatment alternative to conventional systemic chemotherapy, external beam radiation, and~     surgical removal of the eye.~   "
173542|NCT01293526|"~     The purpose of this study is to correlate the three lead placement (wires that go to the~     heart) possibilities and the responses from the patient's heart. This will be done with the~     help of an echocardiography and SonR signals, which is an external device that is capable of~     detecting sounds created by the heart.~   "
173543|NCT01293513|"~     Although the introduction of Highly Active Anti-Retroviral Therapy - HAART - has dramatically~     altered the course of HIV/AIDS, true cure is still unattainable and patients are required to~     take these medications for the rest of their lives. As is well known, the prolonged use of~     such agents is associated with serious, sometimes life-threatening side effects, metabolic~     disturbances such as diabetes and an increased incidence of myocardial infarction.~      In 1999, a patient with acute HIV infection was treated soon after diagnosis (Berlin~     patient). However because of intercurrent conditions, treatment was interrupted on two~     occasions. After the third introduction of therapy, treatment was terminated (arbitrarily)~     and the patient was found to have undetectable virus throughout a follow up of approximately~     18 months. The possible explanation of this phenomenon was autovaccination. Other workers~     have tried Structured Treatment Interruption (STI) in Acute/Primary HIV Infection with~     controversial results, possibly because there were too few cycles of treatment interruption.~      In a patient treated in our center for Acute HIV infection, after initial HAART therapy, he~     underwent gradually increasing interruptions of treatment from 1 to 7 weeks. After complete~     cessation of treatment, the patient was followed for 3 years, where CD4 levels were normal,~     CD4/CD8 ratio remained above 1 and the viral load was undetectable.~      Our plan is to study patients with Acute/Primary HIV Infection, who have been treated with~     HAART for at least one year. Once they have been shown to have undetectable virus (less than~     40 copies HIV RNA per milliliter) and CD4 above 500 per microliter with a CD4/CD8 above 1,~     they can be enrolled in the STI study.~      The study will comprise 6 groups of 4 cycles of treatment/interruption with an increasing~     duration treatment interruptions alternating with treatment intervals over a 33 month period.~     Altogether there will be 24 treatment interruptions, lasting from 1 week to 6 weeks. During~     this time the patients will be regularly monitored for clinical events and laboratory~     parameters.~      The purpose of the study is to determine whether patients with acute/primary HIV infection~     undergoing graded STI can achieve a normal immune status and undetectable viral load on a~     long-term basis.~   "
173544|NCT01293500|"~     Recent advances in critical care medicine have dramatically improved morbidity and mortality~     of critical illness. Goal-directed therapy protocols have been instrumental in this change.~     Goal-directed therapy standardizes the rapid delivery of definitive care in illnesses such as~     SIRS (Systemic Inflammatory Response Syndrome) and head trauma. Although this treatment~     approach has been shown to improve clinical outcomes, it has not been widely adopted outside~     academic medical centers. Further improvement in outcomes of critical illness is likely if~     goal-directed therapy is utilized early in the course of care. To facilitate this early~     adoption, goal-directed therapeutic protocols should be developed and implemented by~     specialized pediatric transport teams. The investigators hypothesize that the institution of~     goal-directed therapy during pediatric interfacility transport will improve the outcomes of~     critically ill children.~      The GRIPIT Trial (Goal-directed Resuscitative Interventions during Pediatric Inter-facility~     Transport) will compare outcomes of pediatric SIRS patients before and after the~     implementation of a goal-directed therapeutic protocol during transport. This will be the~     first test of goal-directed therapy in the transport environment. Data will be collected on~     pediatric SIRS patients transported by the Angel One Transport Team at Arkansas Children's~     Hospital before and after protocol implementation. Outcome measures will include length of~     hospital stay, length of intensive care unit (ICU) stay, incidence of multiple organ~     dysfunction syndrome (MODS), and required therapeutic interventions during ICU stay (TISS-28~     scores). In addition, NIRS (Near-Infrared Spectroscopy) monitoring will be used as a cerebral~     and somatic oxygenation trend monitor, to determine its effectiveness as a resuscitation~     guide for pediatric SIRS during transport. NIRS trends are useful as a surrogate marker for~     systemic venous saturations, known to decrease with severe SIRS.~   "
173545|NCT01293487|"~     The purpose of this study is to determine the safety and tolerability of RN564 in women with~     osteopenia and healthy men.~   "
173546|NCT01293474|"~     With the new software tool (EDI, enhanced depth imaging) of the Spectralis® spectral-domain~     optical coherence tomography (SD-OCT) it is possible to visualize and measure the choroidal~     thickness. In glaucoma a vascular component is known. Therefore a difference of choroidal~     thickness in glaucoma patients and healthy controls is proposed.~        -  Trial with medical device~   "
173547|NCT01293461|"~     The purpose of this study is to assess safety and tolerability and determine the~     pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of~     CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.~   "
173548|NCT01293448|"~     The purpose of this study is to evaluate a cryoablation technique used to ablate human~     esophageal mucosa.~   "
173549|NCT01293435|"~     This study will collect real-life data from patients with community acquired pneumonia (CAP)~     OR complicated skin and skin structure infections (cSSSI) to assess the burden of the~     disease, review the treatment pathways, evaluate how health resources are used and identify~     any areas of unmet medical needs. The aim of the study is to compare how patients who are~     admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by~     collecting data to understand the patient and disease characteristics, current practice of~     treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10~     European countries.~   "
173550|NCT01293422|"~     This clinical trial is designed to study the effects of pregnane X receptor activator~     rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main~     hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance~     test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects will be~     given 600 mg of rifampicin a day for a week. The main outcome measures are the changes in the~     glucose and insulin levels during oral glucose tolerance test.~   "
173551|NCT01293409|"~     Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective~     disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other~     hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular~     transcranial phototransduction has physiological influences such as changed reproductive~     cycles and increased brain serotonin levels. Therefore, the investigators run a randomized,~     placebo controlled, double blind, dose finding study on the putative effect of transcranial~     bright light in the treatment of SAD.~   "
173552|NCT01293396|"~     The aim of the study is to investigate meal-related treatment with either premixed Insulin~     Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free~     fatty acids excursions after a standard breakfast and lunch.~   "
173553|NCT01293383|"~     The purpose of this trial is to to investigate the safety of LEO 90105 compared with its~     vehicle after multiple administration (twice daily, 5 days) in healthy Japanese male~     subjects.~   "
173554|NCT01293370|"~     The purpose of this study is to explore, through a qualitative approach, how a group of~     people with serious mental illness experienced the integration of a vocational rehabilitation~     intervention during their admittance in hospital.~   "
173555|NCT01293357|"~     The objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO~     90105 and its components by patchtest (48 hours closed patch test and photo patch test) in~     healthy Japanese male subjects.~   "
173556|NCT01293344|"~     The purpose of this study is to document differences between men and women in changes in~     metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric~     controlled nutritional intervention based on the Mediterranean diet in which all foods and~     drinks are provided to subjects. The investigators hypothesize that the decrease in~     LDL-cholesterol will be more important in men than in women.~   "
173557|NCT01293331|"~     The purpose of this study is to detect acute febrile episodes and dengue infection in five~     Latin American countries to assess dengue seroprevalence.~      Primary objectives:~        -  To identify acute febrile episodes among the cohort in order to detect the presence of~          dengue infection.~        -  To describe the dengue seroprevalence among the cohort at baseline and at the end of the~          study.~   "
173558|NCT01293318|"~     The purpose of this study is to investigate if there is an association between copeptin level~     in serum and the severity of pancreatitis and if copeptin can be used as a predictor for~     organ failure and pancreatic necrosis with or without superinfection.~   "
173559|NCT01293305|"~     The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70~     decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the~     therapeutic properties of this association in control of osteoarthritis, especially in~     reducing pain and improving movement. The combination of chondroitin sulfate with glucosamine~     sulfate offers a significantly higher tolerance than most drug treatments and, moreover, has~     long lasting effects even after stopping treatment.~   "
173952|NCT01288196|"~     The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune~     responses of CNTO 6785 after administration to healthy adult volunteers.~   "
173560|NCT01293292|"~     Previously the approach to treatment of osteoporosis has been to use medications which~     prevent excessive resorption of bone. More recently medications that build up new bone, i.e.~     anabolic treatments, have been, and are being, developed. The investigators would like to~     develop a strategy for evaluating the effectiveness of anabolic therapies by studying a~     currently available therapy (teriparatide). This strategy could then be used to assess new~     anabolic treatments as they are developed for use in humans.~      The aims of this study are 1) to fully describe the changes in bone turnover in response to~     teriparatide by biochemical marker type and by time; 2) to fully describe the changes in bone~     mineral density (BMD) in response to teriparatide by site, bone compartment and time.~      If this study is able to identify an early response to treatment, then this will help speed~     up drug development in this area, by allowing the identification of promising new anabolic~     drugs and enabling us to understand their mechanism of action. This will benefit the~     investigators patients as the investigators will have a better understanding of how these~     drugs work.~   "
173561|NCT01293279|"~     The primary objective of this study is to estimate the distributions of HCV viral/human~     genotypes (including IL28B and inosine triphosphatase, ITPA), and HCV RNA level among ITPA~     gene among 1000 Han ethnic Chinese patients with HCV who are antiviral treatment naive at the~     time the study is conducted.~   "
173562|NCT01293266|"~     Propofol is routinely used for general anesthesia during pediatric heart catheterisation.~     Propofol infusion syndrome (PRIS) is a rare, but often fatal complication mainly defined by~     bradycardia with progress to asystolia during propofol infusion. Metabolic acidosis is~     regarded as an early warning sign of PRIS. In this study the effect of propofol and~     sevoflurane on serum base excess, pH and lactate are examined during pediatric heart~     catheterisation.~   "
173563|NCT01293253|"~     Many adults find it difficult to perform physical exercise during leisure. The workplace may~     provide an optimal setting to encourage a healthier lifestyle. This study investigates the~     effect of daily stair walking at the workplace on cardiovascular health.~      The main hypothesis is that daily stair walking for 10 weeks compared with a control group~     results in increased aerobic fitness.~   "
173564|NCT01293240|"~     The purpose of this study is to compare the overall performance of a monthly replacement~     contact lens when worn for one month and when worn for two weeks.~   "
173565|NCT01293227|"~     This research project is a multi-year proposal, with the goals of answering and evaluating~     the following:~        1. Does an intramedullary locking device applied in an extra-articular distal radius~          fracture improve post operative pain, diminish hospitalization, improve early return to~          activity and function compared to a volar locked plate?~        2. Does an intramedullary locking device applied in an extra-articular distal radius~          fracture improve patient related outcome measures compared to a volar locked plate?~   "
173566|NCT01293214|"~     Limb transplantation surgery is the transfer of one or more limbs from a deceased human donor~     to a patient with single or multiple limb amputation. Hand transplantation is an innovative~     reconstructive procedure that has the potential to significantly improve the lives of hand~     amputees. The purpose of this study is to develop the best practices for multiple limb~     transplantation that will improve the outcomes of future limb transplant recipients.~   "
173567|NCT01293201|"~     The overall development plan is to show that the combination of tried-and-proven~     decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine~     maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a~     comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of~     symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age~     and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose,~     itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or~     chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the~     favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to~     assess and compare the safety and efficacy of the study drug in a larger group comparatively~     with a placebo control group. Objectives: A) To report and compare total symptom scores (TSS)~     by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion,~     rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period. B)~     Report any side effects or adverse drug reactions and rate the severity of any incident. C)~     Compare and report each symptom score, total nasal symptom scores (TNSS), and post-nasal drip~     symptom scores (PND-S) between the two study arms.~   "
173568|NCT01293188|"~     The bioprosthetic aortic valve replacement is a frequent intervention because of the~     predominance of calcified aortic stenosis, which is the most common valvular disease, and~     aging of the population.~      International guidelines recommend anticoagulant therapy during the 3 postoperative months,~     but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the~     low level of evidence available studies and their sometimes conflicting conclusions.~      Questionnaires sent to practitioners have highlighted discrepancies between common practices~     and recommendations.~      However, there is no analysis of actual patterns of postoperative anticoagulation after~     aortic valve replacement with bioprosthesis.~      The aim of the ARVA observatory is to establish a cohort of 600 patients enrolled in 3 months~     and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers French.~   "
173569|NCT01293175|"~     Whole grains (WG) contain numerous physiologically bioactive compounds, a key group being~     polyphenolic compounds such as ferulic acid (FA). These whole grain polyphenolic compounds~     have been shown to have potent antioxidant activity. This study will evaluate bioavailability~     of WG bioactive compounds and their physiological impact on health outcomes, mainly related~     to inflammatory, oxidative and hormonal status, in overweight subjects.~   "
173580|NCT01293032|"~     This randomized pilot clinical trial studied whether the Oncotype DX gene expression~     Recurrence Score (RS) would be useful for helping make a decision about which type of~     pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with~     hormone responsive cancers that were not suitable for breast conserving surgery. The RS is~     currently used to predict the risk of distant recurrence and the benefit of the addition of~     chemotherapy to hormonal therapy in the adjuvant setting.~   "
173581|NCT01293019|"~     To study the contribution of osteopathy on the reduction of pain in adult patients with~     cystic fibrosis~   "
173570|NCT01293162|"~     Cardiovascular risk has been shown to increase with increasing blood pressure values. As a~     consequence, it results mandatory to achieve lower blood pressure goals in all hypertensive~     patients, taking into account that all drugs always have some side effects that can be very~     dangerous and/or uncomfortable for the patients leading to a reduced compliance. Thus,~     pharmacological treatment should be delayed until it results really necessary.~      The availability of natural substances with a therapeutic action has modified this scenario~     because of their reduced potential to cause undesirable effects (compared with drugs). In~     order to choose among various nutraceuticals (natural foods compounds with health benefits,~     including the prevention and/or treatment of diseases), preference should be given to those~        -  produced according to the same Good Manufacturing Practice used for drugs, to be sure~          that the finished product has a standard, reproducible composition~        -  for which efficacy and safety in the recommended indications are supported by clinical~          trials.~      An example of a product with these characteristics is Armolipid Plus, a combination of~     nutraceuticals with a demonstrated anti-dyslipidaemic effect. Recently, a large clinical~     intervention study showed evidence that treatment with Armolipid Plus leads to a significant~     decrease in the overall cardiovascular risk, measured using the Framingham Risk Score.~      Progress in Research and Development in this field has led to a new patented and registered~     combination of nutraceuticals: Armolipid Prev, containing orthosiphon and CoQ10, with~     antihypertensive activity, berberine, red yeast, policosanol and orthosiphon with~     antidyslipidaemic effect and folic acid, reducing plasma homocysteine levels.~      In addition to the established anti-dyslipidaemic activity of Armolipid plus, Armolipid Prev~     has a significant antihypertensive effect, which is beneficial in all those patients with~     high blood pressure values without a defined indication to begin a pharmacological treatment~     according to the current guidelines. The antihypertensive effect of Armolipid Prev,~     documented by ambulatory blood pressure monitoring, in addition to the lowering effect on~     dyslipidaemia and even on abdominal girth, represents a new opportunity for complete and~     early, effective and safe cardiovascular disease prevention.~   "
173571|NCT01293149|"~     Knee arthroscopy is a common surgical procedure in pediatrics in which the knee joint is~     visualized through a small camera to help diagnose and treat knee problems. This procedure is~     commonly accomplished with the use of general anesthesia. Regional anesthesia is commonly~     completed with a single injection of local anesthetic around the femoral nerve to provide~     pain relief for several hours following knee arthroscopy. The intent of this study is to~     examine the effects of clonidine in addition to local anesthetics for femoral nerve blockade~     in providing children and adolescents post-operative analgesia. The investigators hypothesize~     the addition of low dose clonidine (1 mcg/kg) provides an additional 4 hours of post~     operative analgesia following arthroscopic knee surgery and reduces post-operative opiate~     requirement.~   "
173572|NCT01293136|"~     This is a retrospective review to evaluate the efficacy of femoral nerve block in providing~     analgesia following reconstructive surgery of the knee and to compare the postoperative~     course of patients who received femoral nerve block with a retrospective cohort who were~     cared for prior to the institution of a regional anesthesia program. The investigators~     hypothesize that femoral nerve blockade limits postoperative opioid needs, improves analgesia~     and facilitates discharge home when compared to intravenous opioid use following~     reconstructive knee surgery.~   "
173573|NCT01293123|"~     The primary aim of this study is to determine the effects of the HIV integrase inhibitor,~     raltegravir, in cerebrospinal fluid (CSF). This will be accomplished by collecting CSF before~     and after initiation of either raltegravir or another antiretroviral, efavirenz, each in~     combination with two other antiretrovirals. Assessments will include HIV RNA levels (viral~     load), neuropsychological testing, mood assessments, and quality of life assessments.~   "
173574|NCT01293110|"~     Patients with neurological disease/injury often suffer from lower urinary tract symptoms,~     which frequently have a negative impact on the patients' health related quality of life. The~     prevalence of lower urinary tract dysfunction is high and the treatment is a challenge~     because available treatments may fail. In this study data of patients with lower urinary~     tract dysfunction treated at the University of Zürich, are prospectively and systematically~     collected in a database.~   "
173575|NCT01293097|"~     This randomized, open label, controlled, parallel group study is designed to test whether~     2-day high dose atorvastatin administration before PCI and 30-day continuous intensive~     atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events,~     as well as 6-month prognosis. The goal is to set up an optimized protocol for peri-PCI statin~     treatment in Chinese CHD patients. Safety will also be observed.~   "
173576|NCT01293084|"~     Previously, the investigators and others have shown that mucociliary clearance (MCC) is~     defective in patients with cystic fibrosis (CF) and it is now thought that alterations in~     airway mucus rheology figure prominently in the impairment. Mucociliary clearance works by~     trapping toxic particles, bacteria and viruses in the lung mucus and then quickly removing~     the mucus out of the lungs. Defects in MCC typically lead to the accumulation of mucus in the~     airways, and this in turn is associated with acute infections, chronic bacterial colonization~     and chronic inflammation. One treatment strategy that is gaining acceptance as an important~     therapy for improving MCC in adults with CF is the inhalation of the osmotic stimulus,~     hypertonic saline (HS). A number of studies have shown that acute inhalation of HS (7%~     saline) significantly improves MCC in adults with CF and results from a recent study indicate~     that two weeks of inhaling HS leads to a significant increase in MCC that is sustained for 8~     hours post inhalation and is associated with significant improvements in FEV1, FVC and~     FEF25-75 values. Since MCC in patients with CF appears to be impaired by adulthood, any drug~     that disrupts or slows the impairment in childhood could prove enormously beneficial in the~     long-term prognosis of the disease. Nevertheless, no studies have been conducted to determine~     if HS treatment improves MCC in children with CF. This is most problematic for physicians who~     care for children with CF who have normal FEV1 and FVC values, since it is unclear if they~     should treat these children with HS or not. This research study is designed to begin to~     answer this question. The investigators hypothesize that acute inhalation of hypertonic~     saline (7%) will improve MCC in CF children with normal pulmonary function. Our hypothesis~     will be tested in a one-year clinical trial that will be randomized and placebo-controlled.~     Twelve children with CF who are 7-12 years old and have normal FEV1 and FVC values will~     participate. Our goal will be to compare MCC in these children on two study visits after~     acute inhalations of placebo (0.12% saline) or hypertonic saline (HS) (7% saline) aerosol.~     The investigators predict that MCC values after acute inhalation of 7% HS aerosol will be~     statistically significantly greater than after placebo inhalation.~   "
173577|NCT01293071|"~     The SATURN ICU-trial studies the effect of antibiotic rotation on the prevalence of~     antibiotic resistant Gram-negative colonisation.~   "
173578|NCT01293058|"~     The purpose of this study is to determine which route of administration is better for~     treatment of opioid overdosed patients~   "
173579|NCT01293045|"~     -  Preliminary scientific studies, in both animals and humans suggest that oral consumption~          of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity~          of osteoblasts responsible for bone formation while improving the bone mineral density~          and biomechanical resistance of long bones.~        -  The objective of this clinical research is to measure changes in biomarkers of bone~          turnover in postmenopausal healthy women, not osteoporotic, in response to consumption~          of hydrolyzed collagen for three months.~        -  For this, we propose to measure blood and urinary markers of formation and bone~          resorption before consumption, then 45 and 90 days after daily consumption of 10 g of~          hydrolyzed collagen.~   "
173953|NCT01288183|"~     The aim of this study is to determine whether a powerful technique of noninvasive brain~     stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking~     and constitute a treatment of tobacco addiction.~   "
173582|NCT01293006|"~     This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant~     (MK-4305) on respiratory function in participants with chronic obstructive pulmonary disease~     (COPD). This is a crossover study, so all participants will receive both suvorexant and~     placebo while on study. The primary hypothesis of this study is that multiple doses of~     suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2)~     during total sleep time in participants with COPD, as compared to placebo.~   "
173583|NCT01292993|"~     The purpose of this study is to determine the effects of LX4211 and metformin on each other~     when given at the same time as single doses to healthy human subjects.~   "
173584|NCT01292980|"~     Patients with a suspected Deep Tissue Injury (or a purple reddened area over a bony~     prominence of their body, which is expected to break down into a pressure ulcer) will be~     place on the Clinitron® Rite HiteTM bed to see if the air fluidized mattress decreases the~     amount of tissue breakdown from their bruise.~   "
173585|NCT01292967|"~     The primary propose of this study is to determine the impact of ingredients and matrices on~     flavanol absorption and metabolism.~   "
173586|NCT01292954|"~     Scientific question to be addressed: To determine the effects of acute blueberry ingestion on~     vascular function and blood pressure in humans~      Hypothesis: Acute consumption of blueberry induces an improvement in blood pressure and~     vascular function through the impact of blueberry flavonoids on the vascular system.~      Study objectives: To determine the dose-dependency of a blueberry drink on blood pressure and~     vascular function in healthy subjects and to determine pharmacokinetics of blueberry~     polyphenols~   "
173587|NCT01292941|"~     To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)~   "
173588|NCT01292928|"~     The primary objective of this clinical study is to determine whether the Innova Stent System~     shows acceptable performance in long-term (12-month) safety rates and vessel patency when~     treating femoropopliteal lesions.~   "
173589|NCT01292915|"~     The main aim of the study is to describes the outcomes of patients with Upper~     Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed~     predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic~     therapies.~   "
173590|NCT01292902|"~     Inspiratory muscle dysfunction is a reduction in the ability to generate pressure and force~     by the inspiratory muscles. This decrease in the strength of these muscles can be attributed~     to biochemical and histological changes. Some patients with CHF showed a reduction of maximal~     inspiratory pressure (MIP) and inspiratory muscle endurance, and such factors known to~     exercise limitation and deterioration in quality of life and worsens the prognosis of these~     patients. This study aims to evaluate the Regional pulmonary distribution volume and the~     influence of enclosures system thoracoabdominal in CHF patients with cardiomegaly associated~     with diaphragmatic weakness during quiet breathing and during exercise for inspiratory muscle~     and its correlation with functional data. The investigators evaluated a total of 31~     individuals divided into two groups: CHF and control. In the control group, twelve volunteers~     participated with similar age, gender and body mass index in relation to the group of~     patients with CHF. The control group participants had an ejection fraction of left ventricle~     (EF)> 50% without cardiac abnormalities of the cameras and MIP over 80% of predicted. To~     conduct the exercise to the inspiratory muscles (EMI) was used for IMT Threshold ® device~     (Threshold Inspiratory Muscle Trainer, HealthScan Products Inc., Cedar Grove, New Jersey) is~     one of the most used for training of inspiratory muscles in patients with several pathologies~     such as CHF. The exercise time was 3 minutes. During this period, participants were~     encouraged to only breathe through the mouth and maintain a respiratory rate between 12 and~     16ipm. Opto-electronic plethysmography measures the volume changes of thoracoabdominal system~     by placing 89 markers formed by hemiesferas covered with retro-reflective paper, taking the~     place of each of these hemiesferas determined by anatomical landmarks on the anterior and~     posterior regions of the chest and abdomen. According to our study, a lower ventilation on~     diaphragmatic region would lead to an increased perception of dyspnea during submaximal~     exercise in this population. Moreover, the observed changes in the pattern of regional~     distribution of ventilation in CHF patients compared to healthy individuals can serve as a~     basis for prospective cohort studies using IMT.~   "
173591|NCT01292889|"~     The investigators are looking for volunteers who have a history of Major Depressive Disorder,~     the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a~     history of these disorders for a research study on genetics.~   "
173592|NCT01292876|"~     The objective of the study is to assess mechanical strength and function in subjects~     undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of~     biologic scaffolds for the restoration of both mechanical strength and function in these~     subjects. This study formally evaluated healing and return of function after an extracellular~     matrix device implantation in 17 male and female subjects participating at the University of~     Pittsburgh under the Department of Plastic and Reconstructive Surgery who suffer from injury~     with loss of skeletal muscle tissue.~   "
173593|NCT01292863|"~     The purpose of this study is to evaluate the impact of Delflex neutral pH (a biocompatible~     peritoneal dialysis solution) on mesothelial cell viability and peritoneal transport.~   "
173594|NCT01292850|"~     The aim of this study is to investigate sterility of ethyl-chloride topical anesthetic spray~     when used prior to an injection. The hypothesis is that the spray does not change the~     sterility of the injection site after skin is prepped.~   "
173595|NCT01292837|"~     To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or~     3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years~     with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2~     Anti-Epileptic Drugs (AEDs).~   "
173596|NCT01292824|"~     This is a phase I pilot study to determine the safety and preliminary efficacy of a novel~     hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing~     liver transplantation.~   "
173597|NCT01292811|"~     The objective of this research program is to conduct a multi-site clinical randomized control~     trial that will evaluate the efficacy of functional electrical stimulation based upper limb~     intervention for people with tetraplegia. This will involve recruiting 84 persons with~     sub-acute tetraplegia across four sites (Montreal,Toronto, Fredericton and Edmonton) and will~     serve to evaluate three new Canadian hand function assessments that have been specifically~     developed for persons with tetraplegia. Although these assessments have been recently tested~     and have shown considerable promise, further evaluation on their clinical utility (in~     particular their responsiveness and validity) is required. As well, they need to be compared~     with one another to determine whether any of these tests is more appropriate for clinical~     applications or whether further test reduction or augmentation may be required. Having~     measures that are sensitive and accurate in assessing hand function is key for systematically~     evaluating emerging therapeutic interventions.~   "
173598|NCT01292798|"~     This is an open-label, Phase I/II study of intravitreally administered ranibizumab either~     0.5-mg and/or 2.0-mg in subjects with clinical, angiographic, and ocular coherence tomography~     (OCT) evidence of diabetic retinopathy with associated diabetic macular edema following~     bevacizumab therapy. Thirty patients will be enrolled in this study.~      Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5~     mg ranibizumab administered every 30 days (±7 days) for 3 injections during the mandatory~     treatment phase (Day 0, Month 1, and Month 2).~      Subjects with complete resolution of diabetic macular edema after 3 intravitreal injections~     of 0.5 mg ranibizumab will be treated as necessary with 0.5 mg ranibizumab to treat recurrent~     macular edema for an additional 9 months (12 months from Day 0). The intent is to administer~     additional ranibizumab treatment if there is evidence of disease activity documented on OCT~     (e.g., intra-retinal fluid, subretinal fluid and/or cystic changes).~      Subjects with residual diabetic macular edema following 3 intravitreal injections of 0.5 mg~     ranibizumab will be receive 3 intravitreal injections of 2.0 mg ranibizumab administered~     every 30 days (±7 days) for 3 injections at the Month 3, Month 4, and Month 5 study visits.~      Beginning at the Month 6 study visit, subjects with complete resolution of diabetic macular~     edema following 3 intravitreal injections of 2.0 mg ranibizumab will treated as necessary~     with 2.0 mg ranibizumab injections only to treat recurrent macular edema for an additional 6~     months (12 months from Day 0).~      Subjects with residual diabetic macular edema following 3 consecutive intravitreal injections~     of 2.0 mg ranibizumab will be treated as necessary with 2.0 mg ranibizumab to treat~     persistent or recurrent macular edema for an additional 6 months (12 months from Day 0).~     Focal photocoagulation or intravitreal triamcinolone may be administered at the physician's~     discretion as an adjunct to ranibizumab injections beginning at Month 6 through Month 12 of~     the study.~      All subjects will make monthly visits for 12 months for evaluation of safety and efficacy.~     All subjects will have their first injection of ranibizumab on Day 0 and undergo a safety~     visit one week (±2 days) after the first injection. At subsequent visits, the subject will~     have a safety evaluation at the monthly scheduled follow-up visit prior to any intravitreal~     injection. Subjects will be contacted by the site personnel 1-2 days after each injection to~     elicit reports of decreased vision or pain or unusual new ocular symptoms in the study eye.~   "
173599|NCT01292785|"~     This ultrahigh-field MRI study gives us the unique opportunity to measure changes in brain~     function and structure induced by long-term opposite-sex steroid hormone administration in~     transsexual subjects. Our aim is 1. to prove the influence of high-dose, long-term~     opposite-sex steroid hormone treatment on functional brain response in transsexuals. 2. to~     investigate the influence of hormone treatment on resting state functional connectivity and~     brain morphology. 3. to investigate differences between transsexuals and healthy control~     subjects in brain function and functional connectivity, brain morphology and structural~     connectivity. In this longitudinal study, transsexuals and healthy control subjects will~     undergo three 7 Tesla ultrahigh-field MRI scan sessions: 1. baseline (before hormone~     treatment), 2. after 4 weeks of treatment and 3. after 4 months of treatment.~   "
173600|NCT01292772|"~     The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant~     radiation therapy on reconstructed breasts.~   "
173601|NCT01292759|"~     Cardiac output can be monitored using different invasive devices. Nexfin HD is a new,~     noninvasive device that uses model flow technology to measure stroke volume and thus computes~     cardiac output (CO). To evaluate this new device the investigators compared esophageal~     doppler CO to Nexfin HD CO in patients scheduled for elective abdominal surgery.~   "
173602|NCT01292746|"~     The purpose of this clinical study is to determine if the Erchonia® ML Scanner (MLS) low~     level laser light device can help to regrow hair on the scalp of females experiencing hair~     loss or thinning.~   "
173603|NCT01292733|"~     The main purpose of this program is to see whether periodically measuring CA-125 (tumor~     marker) levels in the blood and undergoing transvaginal ultrasounds over time will be~     effective in the early detection of ovarian cancer.~   "
173604|NCT01292720|"~     In cross-sectional and prospective cohort studies, vitamin D deficiency is associated with~     increased mortality, cardiovascular events including sudden cardiac death and stroke,~     diabetes, hypertension and impaired function of the immune and musculoskeletal system. The~     action of vitamin D on the cardiovascular system regulates cardiac function, endothelial and~     vascular smooth muscle, and, the renin-angiotensin system. Treatment with sufficiently high~     doses of vitamin D may represent a promising and inexpensive intervention option. To date,~     there are few data on the effect of cholecalciferol treatment in patients with chronic heart~     failure. The primary objective of this study is to investigate whether oral vitamin D~     supplementation improves chronic heart failure (measured with the surrogate parameter of~     NT-proBNP levels at month 0 and 6).~   "
173605|NCT01292707|"~     Background.~      Overdiagnosis of malaria is widespread in health facilities throughout Africa, a situation~     that is unsustainable given the relatively high cost of artemisinin combination therapy~     (ACTs) compared to older antimalarials. In addition it often denies patients treatment for~     their actual illness and generates unreliable data for health planners. For these reasons the~     National Malaria Control Programme introduced revised guidelines for malaria diagnosis and~     treatment in 2006 restricting the recommendation for antimalarial treatment in patients over~     the age of 5 years to those with a positive blood slide or malaria rapid diagnostic tests~     (RDTs) result. To support this, RDTs will be introduced into primary care health facilities~     in Tanzania starting in 2009.~      The high accuracy of current rapid diagnostic tests (RDTs) provides the potential for a~     cost-effective solution to the problem of malaria overdiagnosis. However, RDTs with revised~     guidelines to restrict malaria diagnoses to RDT-positive patients have been unsuccessful~     unless accompanied by unsustainable levels of supervision and training.~      Primary objective.~      To conduct a trial of interventions directed at prescribers or prescribers and communities~     compared to control groups to improve adherence to national guidelines for prescription of~     antimalarial treatment when supported by RDTs in primary health care facilities in NE~     Tanzania.~      Methods~      All 60 participating health facilities will receive RDTs and basic training in their use and~     a copy of current NMCP/MOH guidelines for each prescribing staff member. A health worker~     intervention arm will, in addition, receive workplace-based interactive training and messages~     from senior staff A health worker-community arm will receive the same training as the health~     worker arm and in addition leaflets will be provided to RDT-tested patients providing~     information on the test and the treatment given. All training materials will be approved by~     NMCP in Tanzania as being consistent with current national guidelines but with the addition~     that prescribers will be asked to follow RDT results in prescribing for patients of any age~     This policy is in line with the most recent revision to WHO guidelines and is supported by~     NMCP in Tanzania.~      Study outcomes will be recorded through a 40% (2 days per week) exit survey of patients.~     Anthropological and economics studies will assess the costs and acceptability of~     interventions.~   "
173606|NCT01292694|"~     The purpose of this study is to test the hypothesis that angiotensin II plays a role in the~     supine hypertension of primary autonomic failure. To determine the contribution of~     angiotensin II to renin and blood pressure regulation in autonomic failure, patients with~     multiple system atrophy [MSA] or pure autonomic failure [PAF] and supine hypertension will~     undergo medication testing with the angiotensin II receptor blocker losartan. The~     investigators will compare the biochemical and hemodynamic effects between MSA and PAF~     patients. In a subset of patients, the investigators will also give the ACE inhibitor~     captopril. Our primary endpoint will be changes in plasma renin activity, and subsequent~     components of the circulating renin-angiotensin system, in response to angiotensin II~     blockade. Our secondary outcome will be changes in hemodynamic measures during administration~     of these drugs.~   "
173634|NCT01292330|"~     Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After~     Preoperative Nutritional Support.~      Study design:~      1.Prospective，randomized, controlled clinical study;2.Patients: The subjects were from Peking~     Union Medical College Hospital (PUMCH).~      Study arrangement:~        1. The collection of patients with selected standard~        2. Preoperative evaluation included nutritional status,liver function and tumor~          characteristics~        3. The experimental group received Preoperative Nutritional Support for 4 days,the control~          group got nothing~        4. Both groups received conventional therapy after operation~        5. The comparation of the clinical outcomes in both groups~   "
173607|NCT01292681|"~     Because of metastatic liver cancer of the colon or rectum, patients will be treated with~     cytotoxic drugs (chemotherapy). In the Radboud University Nijmegen Medical Centre the~     investigators investigate whether the imaging techniques at an early stage of treatment can~     predict which patients will have benefited from this treatment.~      In the study the investigators use two different scanners: a MR (magnetic resonance) scanner~     and a PET (Positron Emission Tomography) scanner combined with a CT (Computer Tomography)~     scanner. An MR scanner is a large magnet and looks like a CT scanner which also makes~     pictures. But instead of using X-rays the recordings are made with magnetic fields. The scan~     consists of a table on which the patient will lie with the head in a half-dome with a camera.~     The examination with the MR scan is not painful and not harmful.~      The PET scan is a type of CT scan that makes (after administration of a radioactive liquid),~     a scan of (part of) the body. The amount of radioactivity that is used for the study is so~     small that it will not have an adverse impact on the patient. This research is two times~     combined with a''normal''CT scan.~      Using the MR scan, the investigators can research the oxygensupply, the aggressiveness of the~     tumour and the degree of liver metastases that die from the chemotherapy . The investigators~     can also, after administration of a MR contrast agent, investigate the blood supply of a~     tumor through imaging. If you are treated with the chemotherapeutic drug capecitabine the~     investigators can monitor the intake of this agent in the liver metastases. The PET CT scan~     tells us more about the metabolism in the liver metastases.~   "
173608|NCT01292668|"~     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a~     certain kind of light. When the drug is active, cancer cells are killed. Photodynamic therapy~     using methyl-5-aminolevulinate hydrochloride cream may be effective against skin cancer.~     PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic~     therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain threshold~     patients with skin cancer~   "
173609|NCT01292655|"~     The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects~     with advanced or metastatic solid tumors who no longer respond to or have relapsed from~     standard therapies.~   "
173610|NCT01292642|"~     The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to~     develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim~     to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent~     marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT~     intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a~     transdermal nicotine patch, will reduce the use of marijuana and nicotine.~   "
173611|NCT01292629|"~     The purpose of this multi-center clinical trail is to determine the safety and efficacy of~     the iSert 251 for the correction of aphakia.~   "
173612|NCT01292616|"~     Atlantoaxial subluxation (AAS) is a complication of rheumatoid arthritis (RA) due to pannus~     formation around the odontoid process of C2 of the cervical spine. It occurs frequently in~     15-30% of all RA patients. AAS may occur relatively early in the course of disease within the~     first years. The diagnosis of AAS identifies a patient population with a poor outcome. There~     is evidence that combination treatment with disease-modifying anti-rheumatic drugs (DMARD)~     may retard the development of AAS. However, it is not known whether treatment with inhibitors~     of tumor necrosis factor alpha (TNF) may lead to regression of cervical pannus and prevention~     or reduction of AAS.~      Clinical studies analysing the effectiveness of TNF-inhibitors combined with conventional~     DMARD therapy, in the treatment of cervical spine involvement leading to AAS, are needed.~     This proposal for a pilot study aims at assessing the feasibility of an MRI-based measurement~     of pannus volume in patients before and after treatment with a TNF-inhibitor.~      Primary objective: To show that measurements of pannus mass with MRI is feasible. Secondary~     objective: To assess whether pannus mass decreases measurably in patients treated with~     TNF-inhibitors.~      This pilot study is prospective, non-randomized. The choice of therapy at any time during the~     study is entirely up to the treating rheumatologist.~   "
173613|NCT01292603|"~     This randomized, parallel-group, multi-center study will compare the pharmacokinetics and~     safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in~     combination with chemotherapy in previously untreated patients with chronic lymphocytic~     leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously~     received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in~     Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6~     cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of~     subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and~     cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug~     is 24 weeks.~   "
173614|NCT01292590|"~     The purpose of this study is to determine if dietary fat alters insulin requirements in type~     1 diabetes.~   "
173615|NCT01292577|"~     This study will integrate and adapt a cognitive remediation (Cognitive Enhancement Therapy~     [CET]) and an affect regulation (Personal Therapy [PT]) intervention for 50 individuals with~     schizophrenia that misuse cannabis. Participants will be randomized to CET/PT plus treatment~     as usual (TAU) or TAU alone and treated for 18 months.~   "
173616|NCT01292564|"~     The purpose of this pilot study is to demonstrate the anatomical modulation of subcutaneous~     fat across the waist and hips that occurs through application of the Erchonia® ML Scanner~     (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.~   "
173667|NCT01291901|"~     The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain~     scores and pain medication usage in subjects with intractable pain due to malignant disease.~     A second purpose is to confirm safety and secondary efficacy measurements.~   "
173668|NCT01291888|"~     The investigators postulate that nebivolol will be more effective than an equivalent dose of~     a comparative BB, specifically sustained release metoprolol succinate, in improving the~     availability of NO, lowering blood pressure, and reducing albuminuria with implications for~     slowing progression of CKD and cardiovascular protection in this high risk population.~      The objective of this proposal is to conduct a randomized pilot clinical trial to determine~     the relative efficacy and tolerability of nebivolol versus sustained release metoprolol~     succinate in improving blood pressure in patients with CKD and albuminuria. The primary~     endpoint would be a decrease in asymmetric dimethyl arginine (ADMA). Secondary endpoints~     would include a reduction in blood pressure, urinary F2-isoprostanes and albuminuria.~   "
173617|NCT01292551|"~     The purpose of this study is to determine whether Bosentan is an effective and safe treatment~     to adolescent and adult (15 years and older) patients, born with one ventricle of the heart~     instead of two (single ventricle physiology) and who have undergone TCPC as a palliative~     surgical treatment. The aim of the TCPC operation is to use the one functioning ventricle to~     pump the blood flow to the body, while the blood to the lungs is received directly from the~     caval veins, and is thus a passive flow, without the aid of a ventricle to actively pump the~     blood through the pulmonary circulation. The resistance in the pulmonary circulation is~     therefore critical to these patients. These patients have markedly lower work capacity in~     bicycle test than the general public. Furthermore they have a high risk of developing~     complications e.g. loss of protein from the intestines.~      Bosentan is a medication that lowers the resistance in the pulmonary circulation. It is~     routinely used for patients with pulmonary hypertension. Some studies have shown that drugs~     that lower the pulmonary resistance can increase exercise capacity significantly in patients~     with single ventricle physiology.~      In this study 80 patients will receive either placebo or Bosentan for 14 weeks. Before and~     after the treatment, bicycle test along with blood samples, stool samples and quality of life~     interviews will be performed. Every four weeks during the study blood samples, physical exam~     and interviews will be performed to ensure the safety of the treatment.~      The investigators expect to find a significant increase in work capacity after 14 weeks in~     the treatment group compared with the placebo group.~      Moreover the investigators hope to find a decrease in intestinal protein loss and an improved~     quality of life.~   "
173618|NCT01292538|"~     The purpose of this study is to determine if 532nm green diode laser light is effective in~     body contouring of the waist, hips and thighs.~   "
173619|NCT01292525|"~     The main objective of this study is to demonstrate the benefit of the withdrawal of~     Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning~     period. The secondary objectives will focus on assessing the risks and consequences of~     withdrawal of Tacrolimus (Prograf®).~   "
173620|NCT01292512|"~     This study aims to develop a risk assessment tool to identify bereaved in risk of complicated~     grief reactions and to implement a bereavement management programme in primary health care~     based on the Dual Process Model of coping with bereavement. Furthermore to enhance~     bereavement care in general practice and to enhance patients' self-management in bereavement~     care.~   "
173621|NCT01292499|"~     The RIMAT‐De study (Rete Italiana per il Miglioramento dell'Adesione al Trattamento nella~     Depressione) is a multicentric Randomized Controlled Clinical Trial aiming at identifying the~     best strategies available to reduce the poor compliance of patients with antidepressant~     drugs. Patients' compliance will be measured within six months of pharmacological treatment,~     comparing the specific contributions of brief psychotherapy and psychoeducational~     interventions: the psychoeducational intervention will encompass the monitoring of drugs'~     side effects and patients' satisfaction. In the rest of the document, for the sake of brevity~     the two treatments previously described will be indicated as psychotherapy and~     psychoeducation. These treatments will be compared with the treatment usually carried on by~     the mental health centers involved (i.e. treatment as usual, TAU). The factorial design of~     the study will take into consideration the combination of the two treatments (i.e.~     psychotherapy and psychoeducation) as well.~   "
173622|NCT01292486|"~     The purpose of this investigation is to establish that hematopoetic stem cells collected on a~     new centrifugal blood separator, CaridianBCT's Spectra Optia Apheresis System, are able to~     reconstitute the hematopoetic systems of patients treated with myeloablative therapy,~     equivalent to hematopoetic cells harvested on the predicate COBE® Spectra platform.~   "
173623|NCT01292473|"~     The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate the efficacy and safety of omalizumab administered~     subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged~     12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite~     standard-dosed H1 antihistamine treatment.~   "
173624|NCT01292460|"~     The purpose of this study is to compare the efficacy and safety of the preservative-free~     fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study~     will enroll patients who have ocular hypertension or glaucoma and who are using timolol or~     prostaglandin.~      The study medication period is 6 months, but the primary evaluation of efficacy is done at 3~     months.~   "
173625|NCT01292447|"~     The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive~     that may be underutilized due to fear of pain during insertion. Although providers frequently~     prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no~     evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled~     trials have been shown to be effective in reducing pain during IUD insertion. While many~     women tolerate IUD insertion well, others have moderate to severe pain. This double-blind~     randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2%~     lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is~     that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced~     pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a~     15 mm difference on the VAS with our sample size. Other data to be collected include~     information regarding age, BMI, obstetric history, lactation status, time since pregnancy or~     delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated~     pain levels, insertion characteristics (time, difficulty, complications), side effects, and~     satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily~     administered option for pain control will be available to providers and patients.~   "
173679|NCT01291745|"~     The present study is designed to determine the mutational status of markers (TET2 and PLCb2,~     cytogenetic aberrations) together with methylation status of the above genes using bone~     marrow and matched buccal cell samples from MDS patients who necessitate to start a treatment~     (i.e. EPO, Lenalidomide, Azacytidine). All patients included in the study will be followed~     for at least 2 years.~   "
173680|NCT01291732|"~     The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics in Asian healthy males administered a single dose of BI 135585.~   "
177676|NCT01239420|"~     The purpose of this study is to evaluate the use of combined clinical-neurological,~     neurophysiologic, neuroradiological and biochemical markers in prognostication after cardio-~     and/or respiratory arrest.~   "
173626|NCT01292434|"~     Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole~     grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks~     of parent handouts, classroom activities related to topics in the handouts, parent and child~     activities to reinforce behavioral constructs, and a one week booster 22 weeks later.~      The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables, and~     whole grains in sack lunches. Additional hypotheses are that lunches at child care centers~     where the program is used will have higher dietary quality than centers without the program~     and that children at the centers where the program is used will have a smaller increase in~     body mass index than children at centers with the program.~      The study will also look at the child's home environment and the childcare center. Hypotheses~     for this research question include~        1. Children at centers with Lunch is in the Bag will have greater frequency of eating~          fruits, vegetables, and whole grains at home than those at centers without the program.~        2. Compared to parents at centers without the program, parents of children at centers with~          Lunch is in the Bag will have~             1. Greater knowledge, expected benefits, support, intentions, and belief in their~               ability for packing fruit, vegetables, and whole grain in their child's sack lunch~               daily.~             2. Availability of fruit, vegetable, and whole grain in the home pantry.~             3. Number of lunches with temperature in the safe range at time of service.~   "
173627|NCT01292421|"~     RATIONALE: Hepatitis B antigen peptide (HBsAg) vaccine may help the body build an immune~     response and help prevent hepatitis B. PURPOSE: This clinical trial studies edible HBsAg~     vaccine therapy in healthy participants who have undergone previous vaccination.~   "
173628|NCT01292408|"~     Hydroxychloroquine is a drug that has been used to treat malaria and rheumatism. It is~     recently discovered that Hydroxychloroquine increases 'autophagy'. Autophagy is a process~     whereby cells eat a part themselves giving them extra energy. Cancer cells use autophagy to~     survive chemotherapy or hormonal therapy. Also, cancer cells use autophagy to survive in~     areas of a tumor where there is a low oxygen level.~      The purpose of this study is to determine whether treatment with the drug Hydroxychloroquine~     leads to a decrease of autophagy in breast cancer tissue.~   "
173629|NCT01292395|"~     Military personnel face many physiological challenges, including sustained physical activity~     and prolonged periods of negative energy balance. Chronic energy deficiency often results in~     a loss of skeletal muscle mass and can reduce overall bone health. Recent evidence suggests~     that dietary interventions that provide protein in excess of the current national dietary~     recommendation may confer protection against the negative effects of energy deficiency on the~     musculoskeletal system. The primary objective of this randomized, controlled study is to~     assess the effects dietary protein intake spanning the current acceptable macronutrient~     distribution range on musculoskeletal health following prolonged energy deficiency. Findings~     from this investigation will improve current understanding of dietary conditions necessary to~     reduce the damaging effects of caloric deficiency on musculoskeletal health in warfighters.~     Furthermore, given the rise in obesity in military populations, findings may aid in the~     development of nutritional weight management strategies that promote healthy weight loss~     without compromising musculoskeletal health.~   "
173630|NCT01292382|"~     Memory is constituted by a set of mental abilities of information processing that will be~     available at a later time. Flawless performance depends on several brain systems and other~     cognitive domains. Normal aging is characterized by cognitive deficits that may worsen the~     production capacity and quality of life. Such deficits represent variations of normal , and~     may stabilize,or even better progress. Include multiple cognitive domains, such as working~     and episodic memory, and attention. Despite the heterogeneity of the nature and severity of~     these deficits, common characteristics were observed in neuropsychological assessment of that~     population, for example, reduction in processing speed. There is an important gap in the~     therapeutic approach of these individuals.~      Transcranial magnetic stimulation (TMS) is a noninvasive and promising intervention, with~     potential to improve memory and cognition activating networks that operate on memory or other~     networks that interfere with cognitive performance. The technique relies on generating a~     variable magnetic field originated from an alternating electric current applied to the human~     skull reaching focal cortical regions.~      This study is a sham-controlled clinical trial, randomized, double-blind study. It will be~     evaluated the effects of repetitive transcranial magnetic stimulation (rTMS) on global~     cognition (memory, attention, language, executive functions, planning, logical reasoning,~     calculation and visual-spatial perception), especially memory, of elderly individuals with~     mild cognitive impairment, included in the domain of cognitive impairment no dementia (CIND).~   "
173631|NCT01292369|"~     The concept of breath testing for various diseases has been around since ancient greece. It~     has been hypothesized that cancer is generating a unique pattern of compounds in patients'~     breath. This study is trying to characterize a novel system, based on nanoparticles~     technology, for cancer diagnosis through breath samples.~   "
173632|NCT01292356|"~     Colon cancer is one of the most common cancers in France with more than 36,000 new cases per~     year. Despite significant advances in therapeutic care, the prognosis of colon cancers with~     metastases remains bad. The treatment of metastatic disease is based on chemotherapy coupled~     with therapeutic antibodies. The most commonly used are anti-EGFR (Epidermal Growth Factor~     Receptor), which allowed a significant increase in patient survival. They are responsible for~     skin toxicity in the form of an acneiform rash which can be debilitating for patients and~     require discontinuation of treatment. However, this toxicity is strongly correlated with~     treatment efficacy. Understanding the mechanisms of cutaneous side effects of anti-EGFR is~     therefore a major challenge to treat and better understand the association with treatment~     efficacy.~      The objective of this study is to investigate a link between cutaneous inflammatory response~     in patients treated with anti-EGFR, serum level of anti-EGFR and treatment efficacy. It will~     be conducted systematic consultations dermatology, skin biopsies and blood samples in~     patients treated with anti-EGFR. From biopsies, it will be searched by an infiltration of~     inflammatory cells and expression of genes involved in skin inflammation.~   "
173633|NCT01292343|"~     Triclosan containing dentifrices are effective in the prevention of inflammatory~     complications following third molar surgery through reducing preoperative oral bacteria load.~   "
173635|NCT01292317|"~     Introduction:~      Patients with pre-existing impaired renal function are prone to develop acute contrast media~     induced nephropathy (CIN). Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker~     predictive for acute renal injury has been shown to be capable for earlier diagnosis of acute~     contrast media induced nephropathy (CIN) in patients undergoing cardiac surgery.~      Intravenous volume load is a widely accepted prophylaxis.~      In this randomized and controlled study, only patients with the need for an intra-arterial~     contrast media (CM) application will be included and receive a standardized, weight-based,~     intravenous hydration before investigation.~      It is the aim of this study:~        1. to evaluate the magnitude of a risk for contrast media induced nephropathy (CIN)~          following intra-arterial angiography in a well defined group of high-risk patients.~        2. to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor~          of contrast media induced nephropathy (CIN) after contrast media (CM) application.~        3. to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared~          to only pre-procedural volume expansion.~      Patients with markedly increased urinary Neutrophil gelatinase-associated Lipocalin (NGAL)~     after investigation will be randomized into one of two study groups:~      Patients of Group A will undergo standard treatment consisting of unrestricted oral fluid~     intake.~      Patients of Group B will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for 6~     hours.~      Endpoints:~      Primary endpoint: contrast media induced nephropathy (CIN) defined by an increase greater~     than 25% of baseline serum creatinine.~      Secondary endpoint: NGAL, Cystatin C, and creatinine values, need for renal replacement~     therapy, death.~   "
173636|NCT01292304|"~     Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites~     in liver cirrhosis. Tolvaptan will be administered in combination with current ascites~     management.~   "
173637|NCT01292291|"~     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find~     prostate cancer and learn the extent of disease.~      PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in~     diagnosing prostate cancer.~   "
173638|NCT01292278|"~     Neuropeptide Y (NPY) may play a major role in the pathophysiology of aneurysmal subarachnoid~     hemorrhage (aSAH). To investigate the correlation of NPY in cerebrospinal fluid (CSF) and~     blood (serum) and the neurological outcome in the acute stage of aSAH.~   "
173639|NCT01292265|"~     To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment~     period measured by Power/Color Doppler and Gray scale Ultrasound.~   "
173640|NCT01292252|"~     The purpose of this study is to determine the effects of 12 weeks of daily treatment with~     teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral~     spine fusion surgery for degenerative conditions of the lumbar spine.~   "
173641|NCT01292239|"~     The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with~     placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in~     treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection in Japan.~   "
173642|NCT01292226|"~     This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic~     parameters of CellCept in patients undergoing primary kidney transplantation, in order to~     assess the impact on clinical outcome and the risks of acute rejection. All patients will~     receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters~     will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24~     weeks.~   "
173643|NCT01292213|"~     The purpose of this study is to investigate the role of Haemophilus influenzae and other~     bacteria in causing chronic cough, through a direct comparison of chronic cough cases and~     healthy controls recruited from paediatric respiratory clinics in the United Kingdom.~   "
173644|NCT01292200|"~     This four-and-a-half-year study will test the efficacy of viewing a theoretically based and~     culturally sensitive video followed by group discussion (vs. single viewing) in increasing~     mammography use. The results of this study will lead cancer control efforts to effectively~     decrease breast cancer screening disparities experienced by Chinese-America women.~   "
173645|NCT01292187|"~     The primary purpose of this study was to evaluate the efficacy of oral calcitonin~     (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral~     density at increased risk of fracture. The secondary purpose of this study was to determine~     if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets~     administered at dinner or at bedtime.~   "
173646|NCT01292174|"~     The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially~     increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the~     administration of four total injections of ibalizumab or matching placebo in each volunteer,~     given once every week, at one of three dose levels. Drug administration begins at the lowest~     dose. After 4 of 8 volunteers in the first group have received all study drug injections and~     have completed 6 additional weeks of follow-up, an independent safety monitoring group will~     review available data before approving initiation of the next higher dose-group. This process~     will be repeated prior to initiation of the 3rd and highest dose-group.~      All volunteers will participate in 2 separate intensive blood sampling periods of 7 days each~     to test drug levels.~   "
173647|NCT01292161|"~     The purpose of this study is to determine the effects of silymarin on outcomes of patients~     with hepatitis C.~   "
173648|NCT01292148|"~     The purpose of this study is to determine that the measurements of rectal and bladder~     temperature are correctly consistent with core temperature by using the pulmonary artery~     catheter during therapeutic hypothermia; rapid cooling, maintenance, and slow rewarming~     phase.~   "
173649|NCT01292135|"~     The purpose of this study is to establish the safety of orally administered PCI-32765 in~     combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR)~     in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).~   "
173650|NCT01292122|"~     The purpose of this study is to evaluate the safety of VCT-01 in split-thickness skin graft~     (STSG) donor site wounds and assess selected parameters of healing at the VCT-01-treated~     donor site.~   "
173651|NCT01292109|"~     The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical~     practice.~   "
173652|NCT01292096|"~     Patients with frequent hospital admissions account for a disproportionate share of visits and~     costs. An intervention that can bridge the gap between hospital and community based care for~     a population of patients with frequent hospital admissions may offer both improved care and~     cost savings if hospital admissions can be appropriately reduced. We are now using data from~     our previous research to inform the development and implementation of an intervention at~     Bellevue Hospital, which will bridge the gap between hospital and community based care for a~     population of patients with frequent hospital admissions.~      We hypothesize that such an intervention can offer both improved care and cost savings if~     hospital admissions can be appropriately reduced.~      In this protocol we outline a strategy to pilot a small-scale intervention on a small subset~     of patients admitted to an urban public tertiary care safety net hospital who are defined by~     our study criteria as at high risk for future readmission. By piloting components of the~     intervention, we aim to assure the intervention functions as planned, and can deliver the~     needed services to high risk patients in a seamless and patient-centered manner. The purpose~     of this feasibility study is to ensure that when our intervention is implemented on a~     larger scale, it appropriately serves enrolled patients needs, and that we are able to~     effectively follow patients during the intervention period.~   "
173653|NCT01292083|"~     This clinical trial studies azacitidine in treating patients with triple negative stage I-IV~     invasive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as~     azacitidine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~   "
173654|NCT01292070|"~     The purpose of this trial is to show that Intradermal Human Fcγ1-Fel d1 fusion protein (GFD)~     is able to block the skin reaction to cat allergen in cat allergic subjects compared to the~     skin reaction to cat allergen alone. This research project is also testing the safety and~     tolerability of this new, experimental treatment, compared to the current treatment of cat~     allergen alone.~   "
173655|NCT01292057|"~     The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer)~     is effective in reducing of alcohol craving and drinking compared to placebo depending on~     participant's baseline level of impulsivity.~   "
173656|NCT01292044|"~     The primary objective of this study is to evaluate the role of elastography (along with~     echographic and cytological data) as a diagnostic tool for thyroid cancer~   "
173657|NCT01292031|"~     1. To demonstrate that colistin iv. is not inferior to meropenem in empiric treatment of~          VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days~          and clinical healing in patients clinically evaluated.~        2. To compare the safety of treatment with colistin vs meropenem in VAP.~        3. To compare microbiological efficacy of treatment with colistin vs meropenem in VAP~   "
173658|NCT01292018|"~     The purpose of study to assess the control of dyslipidemia in the Indian diabetic population~     treated with any hypolipidemic agent.~   "
173659|NCT01292005|"~     The purpose of this study is to determine the effects (good and bad) of giving a drug called~     pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests~     associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and~     Drug Administration (FDA) for treatment of circulation problems, but its use in this study is~     investigational, which means that the FDA has not approved it for the treatment of~     pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.~   "
173660|NCT01291992|"~     The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac~     surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.~   "
173661|NCT01291979|"~     This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine~     injection on the relief of pain in patients undergoing tonsillectomy.~      A total of 62 patients will be randomized into one of two groups (group C or group I) based~     on Excel number generation.~      Patients in group C will receive received normal saline intravenous injection, and patients~     in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a~     continuous lidocaine infusion of 2 mg/kg/hr.~      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients~     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12,~     24, 48 hours postoperatively.~   "
173662|NCT01291966|"~     The purpose of this study is to demonstrate that an intervention based on the motivational~     interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to~     reduce the errors of Medication in major measure that the habitual intervention.~   "
173663|NCT01291953|"~     To verify if the screening opportunistic of Atrial Fibrillation (AF) by means of the~     measurement of the arterial peripheral pulse is more effective than the habitual practice for~     the early detection of AF in 65-year-old who come to Primary care~   "
173664|NCT01291940|"~     The goal of this study is to better understand what effect emollients (moisturizers) have on~     the skin in young children and adults.~      Subjects will be recruited from PI and Sub-I clinics and Oregon Health & Science University~     (OHSU) research opportunities website.~        1. Adult and Adolescent Study:~           Moisturizer Intervention - There will be 2-3 visits for this study: a screening visit, a~          baseline visit, and a final visit. Adults with a history of eczema will be asked to~          apply one of four possible moisturizers to one arm and nothing to the other arm for four~          weeks. The moisturizers, which will be assigned to the subjects, include either Cetaphil~          Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Vaseline~          100% Petroleum Jelly. Subjects can use other skin treatments as needed for their skin~          condition, but may not treat the arms during the study. Non-invasive tests of the skin~          will be made at Visit 1 and after four weeks (Visit 2). The skin measurements that will~          be performed are:~             -  Transepidermal loss (TEWL)- measures how much water is lost across the skin barrier~             -  Skin Cohesion and TEWL - TEWL after 5, 10, 15, and 20 tape strips will measure skin~               barrier function after tape-stripping~             -  Skin electrical capacitance - measures the moisture in the top layer of skin~             -  Skin pH - measures the acidity of the skin~             -  Stratum corneum cohesion assay - tape-stripping to measure the protein removed from~               the top layer of skin~             -  Lipidomic analysis - measures the lipids, or oils, in the top layer of skin Control~               - There will be 1-2 visits for this group: a screening visit and baseline visit,~               which can be combined. Non-invasive tests of the skin will be taken and include the~               skin measurements that will be performed are the same as the Moisturizer~               Intervention group.~        2. Pediatric Study: There will be 2-3 visits for this study: a screening visit, a baseline~          visit, and a final visit. Infants and toddlers between 3 months and 3 years of age~          without a history of skin barrier diseases will be assigned to a moisturizer, which~          include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe~          Moisturizing Cream, or Aveeno Skin Relief Moisture Repair Cream. Non-invasive tests of~          the skin will be made at Visit 1 and after four weeks (Visit 2).~             -  TEWL- measures how much water is lost across the skin barrier~             -  Skin electrical capacitance - measures the moisture in the top layer of skin~             -  Skin pH - measures the acidity of the skin~   "
173665|NCT01291927|"~     The purpose of this study is to investigate the feasibility, safety, and long-term prognosis~     of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of~     early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis~   "
173666|NCT01291914|"~     The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005~     for the treatment of pain in patients with osteoarthritis of the knee.~   "
173669|NCT01291875|"~     The studies that correlate periodontal disease (PD) and diabetes mellitus (DM) suggest that~     individuals with poor glycemic control are at increased risk for developing infections.~     Despite being controlled for other important risk factors, diabetic patients are three times~     more likely to develop PD, and therefore, periodontitis has been proposed as the sixth~     complication of DM.~      Besides the effect of diabetes on DP, the reverse has also been studied over the past 15~     years, through the idea that chronic and acute infections can directly affect the tissue~     resistance to insulin. Recent studies have provided evidence that controlling periodontal~     infection has an impact on improvement of glycemic control in diabetes mellitus patients. The~     vascularity of the inflamed periodontal tissue serves as a gateway to inflammatory mediators,~     pathogenic bacteria and their products into the bloodstream. Some researchers have suggested~     that periodontal treatment in type 2 diabetes mellitus (DMT2) patients, results in beneficial~     effect on the level of glycemic control. However, there is no conclusive evidence to support~     this hypothesis.~      This research project aims to determinate the impact of periodontal therapy on metabolic~     control in DMT2 individuals, and determinate the possible association between periodontal~     disease and DMT2. For the HbA1c outcome this clinical trial had a sample size calculation~     estimated at 120 patients. For the inflammatory serum markers this study had a sample size~     estimated at 22 individuals. Blood samples will be collected for evaluation of Hba1c and~     inflammatory serum markers. This data will highlight the possible role of periodontal therapy~     on DMT2 metabolic control.~   "
173670|NCT01291862|"~     Obstructive sleep apnea is a common disorder linked to serious long-term adverse health~     consequences; such as hypertension, metabolic dysfunction, cardiovascular disease. Retinal~     vascular occlusion is related to many systemic illnesses especially hypertension. Obstructive~     sleep apnea is also related to vascular endothelial dysfunction and vascular endothelial~     growth factor elevation which causes vision threatening complications of retinal vascular~     occlusion. Therefore the relationship between obstructive sleep apnea and retinal vascular~     occlusion should be studied.~   "
173671|NCT01291849|"~     After nasal surgery, emergence cough or straining will produce venous engorgement and~     increase bleeding from the surgical site, so the necessity for smooth extubation without~     severe cough during emergence provides a challenge for the anesthetists. Recently,~     remifentanil is commonly used short-acting opioid, and several studies have demonstrated the~     antitussive effect of remifentanil via effect-site target-controlled infusion during~     emergence. However, there may be gender difference in response to opioid, and the previous~     studies about antitussive effect of remifentanil are targeted at female patients and there is~     no investigation of effect site concentration of remifentanil for male patients undergoing~     nasal surgery. The purpose of this study is to evaluate the effect-site concentration of~     remifentanil via target-controlled infusion for preventing cough in man after sevofluorane~     balanced anesthesia.~   "
173672|NCT01291836|"~     AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in~     predicting worsening kidney function in patients who present with acute heart failure (AHF)~     and who are treated with diuretics. It is believed that rising NGAL levels in the blood~     and/or urine can predict acute kidney injury. It is also believed that patients who are~     admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.~   "
173673|NCT01291823|"~     Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over~     30 fractions, and concurrent with Gefitinib.~   "
173674|NCT01291810|"~     The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II~     clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of~     clinical efficacy are promising.~      The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in~     subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to~     anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune~     responses and the safety elicited by TNF-K will also be evaluated.~   "
173675|NCT01291797|"~     This study aims to examine performance on a neurological screening test, the Dubowitz, and~     sleep wake cycles on amplitude integrated electroencephalogram (AEEG) in neonates with~     congenital heart disease (CHD) as a way to potentially predict longterm motor outcome. It~     will compare the results of these studies to neonates without CHD.~   "
173676|NCT01291784|"~     TGF-β is a cytokine that is found to be upregulated in the bone marrow of patients with~     myelofibrosis. This cytokine likely plays a dual role in promoting myelofibrosis and~     myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. The~     investigators propose that inhibiting the TGF-β signaling pathway in MF will decrease the~     fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation.~     This is a novel approach to the treatment of patients with myelofibrosis.~   "
173677|NCT01291771|"~     Cardiovascular diseases are the leading cause of mortality in patients with end stage renal~     disease (ESRD). They often have myocardial ischemia (a major predictor of mortality) on non~     invasive testing (Stress echocardiography and/or myocardial perfusion scintigraphy) but the~     incidence of significant coronary stenosis (>70%) is low. The goal of this observational~     study is to evaluate the incidence and clinical outcomes of proven myocardial microvascular~     disease in patients with end stage renal disease scheduled or not for kidney transplantation.~     These patients routinely undergo non invasive detection of myocardial ischemia. Patient~     included in the study will be followed up for 2 years for major cardiovascular events.~     Patients with detected myocardial ischemia during non invasive testing are being explored by~     coronary angiography. During coronary angiography additional detection of myocardial~     microvascular disease is being performed by simultaneous measurement of Fractional Flow~     Reserve (FFR) and Coronary Flow Reserve (CFR) followed by calculation of the index of~     microcirculatory resistance (IMR).~      Comparison of cardiovascular outcomes between patients with and without myocardial ischemia~     and patients with and without myocardial microvascular disease will be performed.~   "
173678|NCT01291758|"~     The purpose of this study is to determine if submaximal exercise by bicycle stress tests with~     pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days~     causes a higher level of exertional exhaustion in GWI compared to healthy veterans (HVets).~   "
174225|NCT01284582|"~     Phase 1 Study :Safety, Immunogenicity and Dose response of ATH03, a new vaccine against the~     cholesterol ester transfer protein (CETP), in healthy male subjects with high density~     lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl.~   "
173682|NCT01291706|"~     Patients with mild to moderate traumatic brain injury (TBI) are at risk for secondary~     neurological deterioration. Their outcome within the first week after injury could be~     predicted by clinical signs, brain CT scan and transcranial doppler (TCD) on admission to the~     emergency room. The investigators aim to evaluate the diagnostic performance of TCD to screen~     patients presented with mild to moderate TBI and mild lesions on CT scan, i.e., Trauma Coma~     Data Bank, TCDB classification II. The principal outcome measure is the negative predictive~     value of TCD.~   "
173683|NCT01291693|"~     The aim of this study is to investigate whether motivation-tailored alcohol interventions are~     more effective when delivered by person or by computer-generated feedback letters. A sample~     of 920 general hospital inpatients with risky drinking will be recruited through a~     computerized screening procedure. Patients with more severe alcohol problems will be excluded~     from the study. Participants will be allocated by time frame randomization to one of three~     study arms: (1) personal counseling based on Motivational Interviewing, (2) computer-expert~     system intervention that generates individualized feedback-letters, and (3) control group~     (treatment-as-usual). The interventions differ in their channel of delivery, but not~     regarding their content. Both intervention groups receive interventions at three time points:~     directly after the baseline-assessment at the general hospital, and 1 and 3 months later by~     mail and phone, respectively. Outcome will be assessed six, 12, 18 and 24 months after~     baseline.~   "
173684|NCT01291680|"~     Chronic pain is common. Up to 10% of the Population has been estimated to suffer from chronic~     pain and up to 5% of the female population has been estimated to suffer from widespread,~     chronic pain and tenderness, thus fulfilling American College of Rheumatology (ACR) criteria~     for classification of fibromyalgia syndrome (FMS). FMS is characterized by the presence of~     both allodynia and hyperalgesia. FMS is also characterized by disturbances of the autonomic~     nervous system such as orthostatic intolerance, postural tachycardia etc. The effect of these~     conditions during gestation and post partum periods is not well known.~      Parturition is a complex process which involves multiple endocrine and physiological changes~     within a short period of time. Severe pain is an important attribute of this natural process.~     The purpose of the current study is to evaluate the impact of chronic central pain on the~     process of parturition. Our hypothesis is, that women demonstrating signs, symptoms and a~     history of central pain, before the onset of active labor, will differ from women not~     demonstrating such traits; these women may require earlier higher does of analgesia, and may~     demonstrate increased hemodynamic lability during labor and delivery.~   "
173685|NCT01291667|"~     Breast cancer is the most common malignant disease and the most frequent causes of cancer~     mortality in females worldwide. The situation is same as the world in China. Trastuzumab has~     been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is~     developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial~     in order to prove Cipterbin® 's efficacy and safety.~   "
173686|NCT01291654|"~     The investigators propose that paracetamol will be similarly effective to ibuprofen in~     treating PDA in the premature neonate, with fewer side effects.~   "
173687|NCT01291641|"~     The purpose of this study is to evaluate the additional effect of probucol or concomitant~     administration of cilostazol and probucol on mean carotid artery intima-media thickness (mean~     IMT) at year 1, 2, and 3.~   "
173688|NCT01291628|"~     Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome~     called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness~     and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side~     effect. There is no way to prevent or an effective way to treat this side effect. The~     investigators aim is to investigate whether wearing socks which contain copper fibers may~     prevent or alleviate the patient symptoms.~   "
173689|NCT01291615|"~     To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant~     therapy after hemihepatectomy~   "
173690|NCT01291602|"~     This is a single and multiple dose study in healthy male and female (of non-childbearing~     potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug~     levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.~   "
173691|NCT01291589|"~     The purpose of this study is to pilot test an innovative program development project in an~     open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention~     on ten (10) HIV-infected men who have sex with men who report very high levels (>10 episodes)~     of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant~     partners).~   "
173692|NCT01291576|"~     The purpose of this study is to determine whether performing colorectal resection in deep~     endometriosis infiltrating the rectum is responsible for a higher rate of postoperative~     digestive and urinary dysfunction when compared to rectal nodules excision (conservation of~     the rectum).~   "
173693|NCT01291563|"~     The purpose of this study is to evaluate the effect of an 800-mg single dose of TMC207 on the~     QT/QTc interval in healthy volunteers.~   "
173694|NCT01291550|"~     The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical~     symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The~     purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify~     neurodegenerative conditions and ADHD based on breath testing.~      Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal~     conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power~     of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six~     nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to~     the NA-NOSE signals in order to detect statistically significant differences between the~     sub-populations, and classification success will be estimated using leave-one-out~     cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the~     chemical composition of the breath using gas-chromatography in conjunction with~     mass-spectrometry (GC-MS).~   "
173695|NCT01291537|"~     The goal of this multicentric prospective randomized controlled clinical and economic study~     is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal~     infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe~     form of Parkinson's disease.~   "
173696|NCT01291524|"~     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a~     pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately~     following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750~     calorie evening meal as compared to a single dose of the pregabalin immediate release~     (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin~     controlled release tablet administered with various caloric sized dinners and at bedtime as~     compared to a single dose of the pregabalin immediate release capsule.~   "
173697|NCT01291511|"~     The purpose of this study is to determine whether Iloperidone is effective in the prevention~     of relapse in patients with schizophrenia~   "
173698|NCT01291498|"~     This study aims to determine whether HIFU treatment is a safe and effective alternative to an~     operation to remove all or part of the affected gland. The objective is to achieve~     biochemical cure (assessed by normal calcium level in the blood at six weeks, six months and~     one year after therapy) without affecting the patient's voice or ability to swallow.~   "
173699|NCT01291485|"~     The purpose of this study is to develop and examine the feasibility and initial efficacy of a~     computer-based intervention to improve medication adherence among people living with HIV.~   "
173700|NCT01291472|"~     The purpose of this study is:~        -  to document ketorolac disposition (concentration/time profile, protein binding,~          metabolism) and its covariates following intravenous (iv) administration of ketorolac~          right after caesarean section and to compare those observations (n=32) with non-pregnant~          state (n=8) (intra-subject PK comparison)~        -  to document biochemical tolerance of ketorolac~        -  to evaluate if optimalisation of ketorolac dose regimen during pregnancy and labor are~          appropriated and needed~        -  to quantify the neonatal exposure to ketorolac through excretion in the breast milk~   "
173701|NCT01291459|"~     Background and Rationale~      Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have~     demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared~     well tolerated with low metabolic toxicity. No data are currently available concerning the~     combination of these 2 drugs.~      Hypothesis~      Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive~     patients infected by CCR5 HIV-1 previously treated for 6 months with a~     Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.~   "
173702|NCT01291446|"~     Background Some patients complain of excessive evacuation, which may become socially~     disabling (Azpiroz F & Malagelada J-R, 2005). However, there no systematic investigation on~     the range of gas evacuation in healthy subjects and in subjects complaining of flatulence~     under basal conditions and in response to a high-flatulogenic diet (Azpiroz F & Levitt DG,~     2009).~      Hypothesis Patients complaining of excessive passage of gas per anus have more intestinal gas~     production and more anal gas evacuation during basal conditions and in response to a high~     flatulogenic diet than healthy subjects. This abnormality is related to the differences in~     colonic microflora.~      Objectives~        -  To determine the normal range of intestinal gas evacuation under basal conditions and in~          response to a high flatulogenic diet.~        -  In patients complaining of flatulence, to determine whether intestinal gas evacuation~          under basal conditions and in response to a high flatulogenic diet is increased.~        -  To identify differences in the microbiota pattern in subjects with normal and excessive~          anal gas evacuation.~        -  In patients complaining of flatulence, to determine the segmental distribution of~          intestinal gas after a diet challenge.~      Methods Healthy subjects (n=20) and patients complaining of flatulence (n=30) will undergo a~     3-day basal phase on their current diet and a 3-day challenge phase on a high-flatulogenic~     diet; patients will be followed-up for 7 days on a low-flatulogenic diet. The following g~     measurements will be performed: daily measurement of the number of anal gas passages with an~     event marker, continuous recording of anal gas evacuation in the laboratory using an~     electronic leakage-free gas collection system, colonic flora analysis by fecal sampling, and~     segmental gas distribution in the gut by abdominal computer tomography (CT) imaging.~      Relevance These studies will allow to develop the normal range of anal gas evacuation during~     basal conditions. Furthermore, a provocative test will be developed for the diagnosis of~     excessive gas production in patients complaining of flatulence. This data will allow a proper~     diagnosis of these patients and will pave the path for a rational management and for the~     development of evidence-based treatment strategies. This pilot study will allow a proper~     design with adequate sample size calculation in future interventional studies.~   "
173703|NCT01291433|"~     Radiation-induced brachial plexopathy (RIP) is a rare and severe delayed peripheral nerve~     complication of radiotherapy, that is spontaneously irreversible with no medical treatment to~     limit or reduce symptoms. The investigators planed in RIP a randomized double blind clinical~     trial, using a pentoxifylline (P)- tocopherol (E)- clodronate combination versus placebo, to~     assess a possible symptomatic regression by a sensory-motor neurological quantifiable and~     reproducible score (modified Subjective Objective Medical management Analytic, SOMA).~      The investigators previously developed a successful PE treatment in symptomatic RI injuries~     via the antioxidant pathway, in clinical phase II and III trails and experiments obtaining a~     major significant radiation-induced fibrosis regression, then the PE clodronate combination~     (PENTOCLO), obtaining a rapid and significant healing of mandible osteoradionecrosis and~     significant neurological signs regression (- 35% modified SOMA score at 18 months) in 50~     partial RIP.~      The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its~     tolerance in long survival patients irradiated before for cancer and presenting with partial~     RIP of upper or lower legs.~      The investigators calculated to include 60 patients to show a significant clinical difference~     between the two groups after 18 months of treatment: PENTOCLO[Pentoxifylline 400 (2x/d) +~     vitamine E 500 (2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple placebo, with~     prednisone 20 (2d/7) for all patients.~      RIP is assessed before treatment and every 6 months by a standardized sensory-motor~     neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and~     various neurological scales of assessment (Visual Analog Scale for pain / VAS for~     paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS],~     muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient~     Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and~     electrophysiology.~   "
173704|NCT01291420|"~     The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal~     vaccination with autologous RNA-modified dendritic cells (DCs) - engineered to express the~     WT1 protein - in patients with limited spread metastatic solid tumors, i.e. breast cancers,~     glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the~     results of our previously performed phase I study with autologous WT1 mRNA-transfected DC,~     the investigators hypothesize that the vaccination with DC will be well-tolerated and will~     result in an increase in WT1-specific CD8+ T cell responses.~   "
173705|NCT01291407|"~     The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting~     toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with~     radiation therapy for locally advanced or recurrent gastric cancer.~   "
173706|NCT01291394|"~     This is a National, Multicentre, Observational Registry to study adherence and long term~     outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth~     hormone treatment from hospitals in France and to assess the level of adherence of subjects~     receiving SAIZEN® via Easypod™.~   "
173835|NCT01289717|"~     There is a need to develop blood and/or urine tests that will help to detect early signs of~     rejection in people who have had kidney transplant. Researchers will examine blood, urine,~     and tissue samples and try to identify genetic markers for certain conditions like rejection,~     response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope~     to be able to diagnose these conditions earlier and improve kidney survival.~   "
173707|NCT01291381|"~     While allergen specific immunotherapy (SIT) is highly effective for allergic diseases in~     children, the underlying immunological mechanisms are unclear. Regulatory T (Treg) cells may~     be crucial in induction of tolerance.~      Our aim was to investigate the role of CD4+CD25+Foxp3+ T cells and IL-10-secreting type I T~     regulatory (Tr1) cells in the response to one year of cluster SIT to Dermatophagoides~     pteronyssinus for allergic rhinitis in children.~      CD4+CD25+Foxp3+regulatory T cells and IL-10-secreting type I T regulatory (Tr1) cells were~     analyzed in children allergic to Dermatophagoides pteronyssinus during one year cluster~     specific immunotherapy (SIT) in a prospective and randomized study. Peripheral blood~     mononuclear cells (PBMCs) were collected from 25 children receiving SIT and 21 receiving~     pharmacotherapy. The frequencies of CD4+CD25+Foxp3+ T cells and allergen-specific~     IL-10+IL-4-, IFN-γ+IL-4-, IL-4+IFN-γ-CD4+ T cells were measured by flow cytometry. Production~     of IL-4, IFN-r, and IL-10 in supernatants from allergen-stimulated PBMC culture was measured~     by ELISA. Finally, the suppressive effect of CD4+CD25highTreg cells from both groups was~     estimated.~   "
173708|NCT01291368|"~     The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients~     influences the development of delirium during their ICU stay and if incidences of delirium~     have an impact on the development of Post-traumatic Stress-Disorder (PTSD).~      Hypothesis 1:~      Patients who are minimally sedated, remember staying in ICU and experiences fewer episodes of~     delirium than patients that are heavily sedated~      Hypothesis 2:~      Former delirious patients are more likely to develop PTSD~      Hypothesis 3:~      Delirium decreases health-related quality (HRQoL) of life after discharge~   "
173709|NCT01291355|"~     The aim of the study is to evaluate the efficacy of a specific maternal position to correct~     fetal position in occipito-posterior during the labor.~      The investigators hypothesize that the maternal position described by the Dr de Gasquet~     facilitate the rotation in occipito-anterior during the labor.~      The calculated sample size is 438 participants (219 in each group)~   "
173710|NCT01291342|"~     Preeclampsia is a form of hypertension that is unique to human pregnancy. The incidence of~     the disease ranges between 2 and 7 percent in healthy nulliparous women. The etiology of~     preeclampsia is unknown.~      Women with preeclampsia may exhibit a symptom complex ranging from minimal BP elevation to~     derangements of multiple organ systems. The renal, hematologic, and hepatic systems are most~     likely to be involved.~      More than 100 clinical, biophysical, and biochemical tests have been recommended to predict~     or identify the patient at risk for the future development of the disease.~      The results of the pooled data for the various tests and the lack of agreement between serial~     tests suggest that none of these clinical tests is sufficiently reliable for use as a~     screening test in clinical practice. As a result there is obviously a great need to develop a~     novel technology for the early detection of this pregnancy complication before its clinical~     manifestations appear. An early detection can help in early treatment to prevent or at least~     minimize the sequel of this disease.~      The aim of this project is the early detection of Preeclampsia and other pregnancy~     complications using volatile biomarkers appearing in exhaled breath and/or blood samples,~     using a simple and inexpensive toll termed NA-NOSE.~      Phase-I: The primary phase of this project is the comparison between volatile biomarkers'~     patterns of pregnant women suffering from Preeclampsia, pregnant women that are considered~     to have Normal Pregnancy, and healthy Non-Pregnant women.~      Phase-II: The secondary phase of this project is the ability to predict Preeclampsia, as~     compared, head-to-head, with other potential predictors used in the current clinical~     practice.~   "
173711|NCT01291329|"~     The purpose of this study is to investigate the safety and efficacy of intracoronary human~     umbilical Wharton's jelly-derived mesenchymal stem cell (WJ-MSC) transfer in patients with~     ST-segment elevation acute myocardial infarction.~   "
173712|NCT01291316|"~     In animal, the GABAergic system modulates central sensitisation, which is a key phenomenon in~     pain processing. The development of GABAA agonists targeting the subunits of the GABAA~     receptor implicated in nociception, but not the subunit implicated in sedation is attractive~     as it opens new perspectives of testing the role of GABAergic modulation of pain processing~     in human volunteers. The purpose of this subproject is to test the effect of the specific α2~     and α3 agonist but sparing α1 effect TPA023 on a human model of peripheral and central~     sensitisation and to correlate its pharmacodynamic effect with the pharmacokinetic of the~     compound.~      The results would contribute to clarify the potential role of these α2/α3 agonist but sparing~     α1drugs in clinical pain conditions.~   "
173713|NCT01291303|"~     The analysis of flow and pressure curves generated by ventilators can be useful in the~     individuation of patient-ventilator asynchrony, notably in COPD patients. To date, however, a~     real clinical benefit of this approach to optimize ventilator setting has not been proven.~     The aim of the present study was to compare: optimized ventilation, driven by the analysis of~     flow and pressure curves, and standard setting (same initial setting, same time at the~     bedside, same physician, while the ventilator screen was obscured with numerical data always~     available). The primary aim was the normalization of pH at two hours, whilst secondary aims~     were change in PaCO2, respiratory rate, patient's tolerance to ventilation (all parameter~     evaluated at baseline, 30, 120, 360 minutes and 24 hours after the beginning of ventilation).~     70 patients (26 females, aged 78±9 years, PaCO2 74±15 mmHg, pH 7.28±0.05, mean±SD) have been~     enrolled, with no basal difference between the two groups.~   "
173714|NCT01291290|"~     The purpose of this study is to investigate the effect of platelet infusion prior to transfer~     to a vascular surgical department in patients with a ruptured abdominal aortic aneurism.~   "
173715|NCT01291277|"~     Patients with liver disease frequently present to the hospital with bleeding from dilated~     veins in their foodpipe (called esophageal varices). The current standard of care is to~     perform endoscopic variceal ligation (placing rubber bands around the varices through an~     endoscope)in patients presenting with bleeding varices. Patients generally receive ligation~     at the time they come in with bleeding and then return at regular intervals to have repeat~     ligation in order to eradicate the varices. However there have been no studies to determine~     the appropriate intervals for esophageal variceal ligation until eradication. We will conduct~     a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients~     that have presented with bleeding varices. Our hypothesis is that one-week ligation will~     achieve more rapid eradication than the two-week interval with a greater proportion of~     patients achieving variceal eradication at 4 weeks after the index bleeding episode.~   "
173716|NCT01291264|"~     Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San~     Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California, San~     Francisco) are conducting a study to evaluate the Abbott RealTime CT/NG polymerase chain~     reaction [PCR] assay (which is a nucleic acid amplification test [NAAT]) for detecting two~     sexually transmitted bacteria, Chlamydia trachomatis [CT] and Neisseria gonorrhoeae [NG],~     using urine samples and swabs from the throat and rectum of men who have sex with men [MSM].~     Using this test on these swabs is experimental because it has not been approved by the Food &~     Drug Administration.~   "
173717|NCT01291251|"~     The guidelines of The Norwegian authorities concerning the use of antibiotics in general~     practice state that for several common diseases such as pneumonia and tonsillitis,~     antibiotics should be given four times daily instead of three times daily. The study´s aim is~     to see whether the patient compliance is significantly reduced in antibiotic regimes of 3 or~     4 daily doses as compared to 1 or 2 daily doses.~   "
173718|NCT01291238|"~     A whole of school intervention with daily physical activity and healthy food for students~     with intellectual disabilities. The aim is to provide plenty of concrete examples of healthy~     life style choices and using school personnel and peers as role models. This will presumably~     result in healthier weight, better fitness and not least in new familiar healthy habits.~   "
173719|NCT01291225|"~     Specific Aim 1 - In collaboration with partners in Ross County, renovate and develop~     playgrounds in Chillicothe.~      Specific Aim 2 - In collaboration with partners in Ross County, promote safe play and play~     areas for children on farms.~   "
173720|NCT01291212|"~     The investigators have previously demonstrated the utility of transdermal testosterone in in~     vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the~     efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating~     hormone (FSHr) during ovarian stimulation in these patients.~   "
173721|NCT01291199|"~     The purpose of this study is to determine whether vardenafil is effective in improving~     clinical symptoms and peripheral blood flow in patients with primary and secondary Raynaud~     phenomenon.~   "
173722|NCT01291186|"~     The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal~     anesthesia has not been well established. The investigators tried to quantify the effect of~     BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine~     between two different BMI groups.~   "
173723|NCT01291173|"~     To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe~     binge eating disorder as measured by the number of binge days per week~   "
173724|NCT01291160|"~     This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12~     weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of~     Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the~     effectiveness of EPIFLO in combination with standard wound therapy on wound healing as~     compared to standard wound therapy alone; and 2) Screening for potential safety issues.~      Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be~     enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen~     consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive~     debridement. Subjects will be randomized to either the Treatment arm or the Control arm.~     Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment~     Period, once two weeks after wound closure and once at the end of 12-week durability Period.~   "
173725|NCT01291147|"~     More hysterectomies are performed laparoscopically either as a total laparoscopic~     hysterectomy or as a laparoscopically assisted vaginal hysterectomy. The advantages of~     laparoscopic surgery include quicker hospital discharge, a shorter convalescence and cost~     effectiveness when compared to open procedures. Laparoscopic hysterectomies (both total and~     vaginally assisted) can lead to discomfort which may lead to a delay in discharge from~     hospital. Continuous infusions of local anaesthetic agents given post operatively to the site~     of operation have the been subject of trials for several operative procedures. To date~     however there have not been any properly controlled studies evaluating whether there are~     benefits of giving a local anaesthetic infusion for 48 hours into the pelvis following a~     total or vaginally assisted laparoscopic hysterectomy. The investigators therefore propose to~     investigate whether giving a local anaesthetic infusion in this fashion decreases the amount~     of rescue and patient controlled analgesia needed, and length of hospital stay. In order to~     do this the investigators wish to conduct a randomised placebo controlled double blind trial.~   "
173726|NCT01291134|"~     The purpose of this study is to evaluate the rate and quality of spinal fusion utilizing~     PureGen Osteoprogenitor Cell Allograft in Anterior Cervical Discectomy and Fusion (ACDF).~   "
173727|NCT01291121|"~     The main objective is to determine the efficacy of intravitreal administration of Ranibizumab~     combined with intravitreous injection of expansile gas and induction of posterior vitreous~     detachment on best-corrected visual acuity and ocular coherence tomography (OCT) macular~     thickness in subjects with neovascular age-related macular degeneration (AMD) with posterior~     vitreomacular adhesion (VMA).~      Secondary objectives are to assess the safety and tolerability of the intravitreal~     administration of Ranibizumab combined with intravitreous injection of expansile gas.~   "
173728|NCT01291108|"~     This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared~     with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in~     patients with primary open-angle glaucoma or ocular hypertension.~   "
173729|NCT01291095|"~     The aim of this trial is to compare the accelerated fractionation radiotherapy and concurrent~     chemo-radiotherapy in locally advanced head and neck squamous cell carcinoma patients in~     terms of loco-regional control, toxicities and quality of life.~   "
173730|NCT01291082|"~     Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted imaging~     (DWI) MR in staging and therapy assessment in breast cancer patients with bone metastases.~   "
173731|NCT01291069|"~     This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic~     response to exercise and exercise capacity in patients with Fontan circulation. Data~     regarding effect size and drug tolerability will be used in the design of a randomized~     multicenter trial. The long-term goal of this investigation is to systematically evaluate the~     effect of tadalafil therapy on exercise performance, quality of life, and delay of functional~     deterioration in patients with single ventricle physiology.~   "
173732|NCT01291056|"~     Clomiphene citrate is commonly used for ovulation induction in women with anovulation,~     correction of luteal phase deficiency or for superovulation as empiric therapy for~     unexplained infertility. Superovulation using clomiphene, usually with intrauterine~     insemination, is usually regarded as first line therapy for unexplained infertility,~     infertility due to mild endometriosis, or infertility with mild or moderate compromise of the~     male factor. The side effect profile reported by some women using clomiphene citrate is~     similar to symptoms of premenstrual dysphoric disorder (PMDD), including tension,~     irritability, depressed mood, affective lability, lack of energy, difficulty concentrating,~     and physical symptoms such as breast tenderness, bloating, headache joint and muscle pain.~     Few studies have been performed to examine the relationship between clomiphene citrate and~     mood symptoms; however, these studies have been limited by their small sample size, potential~     for recall bias and lack of randomization. Moreover, the experience of infertility is~     dysphoric in and of itself. Therefore, a rigorous evaluation of whether, when in the cycle,~     and how often clomiphene is associated with mood changes is needed. Such a study would add to~     the body of literature on this topic in three important ways: 1) use of prospective data~     collection to more accurately identify commonly reported symptoms, 2) characterize the timing~     of symptom occurrence relative to treatment cycle, and 3) provide information relevant to~     planning of future studies involving targeted treatment of clomiphene citrate induced~     symptoms. If clomiphene use is shown to affect mood, the results would point to an important~     avenue for psychopharmacologic insight into relationships between mood and sex steroids.~      OBJECTIVES:~      Specific Aim #1: To identify psychological and physical symptoms experienced by women taking~     clomiphene citrate for superovulation in a prospective, placebo controlled trial setting.~      Specific Aim #2: To determine whether measures of the emotional and physical state prior to~     the administration of clomiphene, predict the occurrence of mood changes during the five days~     of clomiphene administration and in the late follicular and luteal phases of the cycle in~     which clomiphene was administered.~   "
173733|NCT01291043|"~     Fibromyalgia is a syndrome characterized by chronic and generalized musculoskeletal pain and~     tenderness in tender points. Its etiology and physiopathology are not well known; therefore~     its treatment is not satisfactory. Having this in view, a search for alternative and~     complementary medicine has been going on. This kind of practice is under pressure to present~     evidences of efficacy. A randomized clinical trial will be carried out with the aim of~     verifying the efficacy of a massage technique called Shiatsu in the improvement of pain,~     flexibility, quality of sleep, anxiety and quality of life of individuals with fibromyalgia.~     A sample of 34 subjects will be divided in Shiatsu Group and Control Group. All subjects will~     be evaluated in the beginning, in the middle and at the end of the treatment. Pain will be~     evaluated by the following instruments: visual analogue scale (VAS) and dolorimetry. The~     V-sit and reach test (VSRT) will be used to assess the flexibility of the hamstring muscles~     and lower back. The sleep will be evaluated with the Pittsburgh Sleep Quality Index (PSQI).~     The State-Trait Anxiety Inventory (STAI) will be used to evaluate anxiety. The evaluation of~     quality of life will be made with two instruments: fibromyalgia impact questionnaire (FIQ)~     and Activities-specific Balance Confidence (ABC) scale. In each treatment session, the~     subjects will be globally evaluated in the 14 main meridians and their respective points by~     touch, identifying points of excessive energy and their severity. The Control Group will wait~     for treatment and remain only with conventional pharmacological treatment, while the Shiatsu~     Group will receive a treatment with Shiatsu during eight weeks. The results will be expressed~     in mean and standard deviation. The normality of the data will be verified by the~     Shapiro-Wilk test. In the intragroup analysis, the T-test for the parametric data and the~     Wilcoxon test for the nonparametric data. In the comparison between groups, the analysis of~     variance (ANOVA) test will be used. The level of significance adopted will be α < 0.05.~   "
173734|NCT01291030|"~     Hypomagnesemia is common in renal transplant recipients and is mainly because of enhanced~     renal magnesium wasting, caused by immunosuppressive drugs (calcineurin inhibitors). Glucose~     metabolism disorders, including insulin resistance and decreased insulin secretion, are also~     prevalent post-transplantation and often precede the development of diabetes. As magnesium~     supplementation has been demonstrated to increase insulin sensitivity in both diabetic and~     non-diabetic patients, its potential therapeutic supplementation (post-transplantation)~     deserves further examination. The hypothesis is that magnesium supplementation in renal~     transplant recipients exerts a beneficial effect on insulin resistance and/or secretion.~   "
173735|NCT01291017|"~     The purpose of this study is to determine the efficacy and the toxicities of the study drug~     PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype~     retinoblastoma protein (RB) and inactivated cyclin dependent kinase (CDK) N2A in the tumor.~   "
173736|NCT01291004|"~     This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared~     to two 28-day oral contraceptive regimens containing different synthetic progestins on~     ovarian follicular activity and hormone levels in healthy women.~   "
173737|NCT01290991|"~     Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects~     of the knee?~   "
173738|NCT01290978|"~     The purpose of this study is to find out if presurgical antiseptic preparations affect how~     well surgical drapes adhere to skin.~   "
173739|NCT01290965|"~     This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing~     hepatitis C virus (HCV) RNA levels.~   "
173740|NCT01290952|"~     Compare completeness and modality of revascularization, operative and postoperative results~     and 1 year clinical outcomes in unselected high risk patients referred for primary coronary~     artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery bypass~     graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).~   "
173741|NCT01290939|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     lomustine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known which regimen of bevacizumab~     given together with lomustine is most effective in treating patients with glioblastoma~     multiforme in first recurrence.~      PURPOSE: The primary objective of this study is to investigate whether the addition of~     bevacizumab to lomustine improves overall survival (OS) in patients with recurrent~     glioblastoma compared to treatment with lomustine alone.~   "
173742|NCT01290926|"~     Prospective non-randomized phase II study assessing the activity of the~     Capecitabine-Sorafenib combination by estimating overall survival of the study population at~     a fixed time point (6 months) and, as an exploratory analysis the overall survival of~     metabolic responders versus non-responders.~   "
173743|NCT01290913|"~     This is a pilot feasibility study, using Xolair pretreatment for oral peanut desensitization.~   "
173744|NCT01290900|"~     This is a single dose study in healthy male volunteers to investigate the effect of high~     doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT~     interval~   "
173745|NCT01290887|"~     The primary objective of the study is to evaluate the long-term safety of reslizumab at a~     dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients~     with eosinophilic asthma as assessed by adverse events, physical examination findings, vital~     sign measurements, and concomitant medication usage throughout the study (every 4 weeks),~     clinical laboratory test results, and measurement of antidrug antibodies.~   "
173746|NCT01290874|"~     We are doing this study to learn how genes affect the way that people, specifically Black~     people, respond to treatment for asthma. Recent studies suggest that people respond~     differently to some asthma medications (eg Serevent, Foradil). Some people feel better when~     they use these inhalers, but others may not, and some people get worse. It seems that this~     difference shows up more often in Blacks than in Whites, which is why we are looking for~     Black subjects for this study. In all people, this difference seems to depend on their genes~     or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil)~     to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic~     obstructive pulmonary disease (COPD). This study will help to see if this medication is also~     useful for treating asthma and whether it works better for some people than the current~     asthma medications.~   "
173747|NCT01290861|"~     The overall objective of this study is to identify a 60 minute cognitive battery, for~     subsequent use in clinical trials, that detects cognitive deficits in early HD and late~     pre-manifest HD compared to controls, and that has a potential to show drug induced~     improvements.~   "
173748|NCT01290848|"~     This project will evaluate the effectiveness of the Take TIME health promotion campaign. The~     Take TIME (Tobacco free, Injury free, Moving daily, Eating healthy) campaign will target~     parents and caregivers of children up to 8 years of age.~      The study will help answer the following research questions~        1. Are community organizations able and willing to deliver a health-promotion campaign~          targeting young children?~        2. What impact does the Take TIME campaign have on the readiness of the community to~          support healthy childhoods?~        3. What impact does the Take TIME campaign have on awareness and achievement of healthier~          lifestyles for young children?~        4. Can health promotion initiatives be institutionalized within the Municipality and~          community organizations so that the campaign will continue beyond the study period?~        5. Are changes in awareness and/or behaviour related to exposure to the Take TIME campaign?~   "
173749|NCT01290835|"~     The purpose of this study is to determine if it is feasible, safe, and effective to use~     Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients~     meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be~     delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total~     of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control~     and site of failure (if any).~   "
173750|NCT01290822|"~     This study tests optimization of biventricular pacing (BiVP) in patients with dilated~     cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in~     patients with advanced cardiac failure. It examines the effects of atrioventricular delay~     (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on~     cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an~     identical heart rate.~   "
173751|NCT01290809|"~     Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of~     the lung cancer population. The prognosis of these patients has improved over the years due~     the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The~     brain, however, remains one of the major sites of failure. Patients with brain metastasis~     suffer from a variety of neurological, cognitive and emotional difficulties that are known to~     adversely affect the health-related quality of life. Prophylactic Cranial Irradiation (PCI)~     can prevent or delay the development of brain metastasis, and as such can improve~     neurological disease-free survival and consequently health-related quality of life. But~     survival is short, and toxicities are real, as PCI in itself can also induce adverse effects.~     The cognitive adverse effects of PCI are not sufficiently illuminated and documented, due to~     the lack of formal and systematic evaluation in patient populations expected to have short~     survival. Also, recent attempts to reduce cognitive side effects of PCI by the application of~     hippocampal-avoidance PCI in order to prevent memory deficits have not been fully evaluated~     yet.~      Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs~     and benefits of this therapy should be investigated properly, to allow for well-informed~     treatment choices.~   "
173752|NCT01290796|"~     The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable~     Single-Incision Sling in the surgical treatment of female stress urinary incontinence.~   "
173753|NCT01290783|"~     Trial design:~        -  Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with Hyaluronic~          acid-Irinotecan or HA-Irinotecan) regimen.~        -  Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.~        -  Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria,~          Poland, Serbia, Russia, Ukraine and the United Kingdom).~        -  Dosing regimen:~             -  Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in~               patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be~               reduced to 150 mg/m2).~             -  Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with~               irinotecan.~             -  5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days~               (total 2400 mg/m2 over 46-48 hours) continuous infusion.~             -  Repeat every 2 weeks for 8 months.~        -  Patient accrual over approximately 12-14 months.~        -  Monitoring to 18 months post-randomization.~        -  390 patients.~        -  Progression Free Survival (PFS) primary endpoint.~        -  Safety analysis on the initial 20 patients.~   "
173766|NCT01290614|"~     The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality~     improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2)~     adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based~     quality improvement program for patients with CKD and assess potential mechanisms for the~     intervention's effect.~      Hypothesis: Implementing a CCM based quality improvement program including system level~     support in the form of collaborative care, a CKD registry, and provider education will 1)~     reduce systolic BP in patients with poorly controlled hypertension, 2) increase the~     percentage of patients appropriately monitored for metabolic complications, and 3) decrease~     the rate of catheter use in patients initiating dialysis.~   "
173767|NCT01290601|"~     This Phase II study is designed to determine whether a single 600 mg dose or 400mg/day for 3~     days of tafenoquine is efficacious, and well tolerated for clearing P. vivax malaria~     infection (blood schizontocidal and gametocytocidal activity) and preventing P. vivax relapse~     (hypnozoite eradication). It will also further establish the safety and tolerability of these~     doses of tafenoquine.~   "
173754|NCT01290770|"~     Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries.~     Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is~     influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is~     associated with an increase risk of cardiovascular complications.~      Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular~     disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein~     molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic~     factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two~     study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is~     a risk factor for recurrent coronary events in obese patient.~      Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway~     inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct~     inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .~      The aim of this study is to research reverse association between Lp(a) and TFPI activity in~     obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and~     effect of aspirin.~   "
173755|NCT01290757|"~     The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of~     dabigatran etexilate made from two different drug product batches.~      The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved~     capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using~     a new capsule shell (Capsugel). The test batch is the drug product intended for future~     commercial use.~   "
173756|NCT01290744|"~     This study is a double-blind, randomized controlled trial examining the effect on ENL~     reactions of giving an additional year of clofazimine after completion of MDT in leprosy.~   "
173757|NCT01290731|"~     The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination~     with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus~     (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in~     Japan.~   "
173758|NCT01290718|"~     This single arm. open-label study will assess the efficacy and safety of Herceptin~     (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or~     recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with~     Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14~     of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle~     followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease~     progression or unacceptable toxicity occurs.~   "
173759|NCT01290705|"~     With this study two different therapeutic exercise regimens will be compared in patients with~     anterior knee pain (patellofemoral pain syndrome, PFPS).~   "
173760|NCT01290692|"~     TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can~     produce immune cells, called 'killer' white blood cells that have the ability to kill large~     numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to~     generate large numbers of those 'killer' white blood cells and to deliver those cells into~     your body so that they can kill your cancer cells.~   "
173761|NCT01290679|"~     The purpose of this study is to investigate the effectiveness and safety of TMC435 compared~     with placebo in participants who are infected with genotype 1 hepatitis C virus who have~     never received treatment before. Participants will also receive peginterferon alfa-2a or~     peginterferon alfa-2b and ribavirin as part of their treatment.~   "
173762|NCT01290666|"~     Primary outcome variable is healing at the final follow up visit.~   "
173763|NCT01290653|"~     This study investigates the effect of two different techniques (dry needling and~     Strain-counterstrain manual technique) on the upper trapezius myofascial trigger point (MTP).~     Subjects with active or latent MTP in this location of the muscle will be identified and will~     be randomly assigned to one out of three groups: dry needling, strain-counterstrain or~     placebo manual technique. Pain pressure threshold, provoked pain, pain at rest, neck~     disability and electromyography (EMG) activity of the upper trapezius will be registered~     before and after six sessions of treatment.~   "
173764|NCT01290640|"~     The objectives of this study are four-fold:~        1. To determine the three-dimensional, in vivo kinematics for subjects having either a~          fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis,~          comparing the in vivo kinematics to determine if one implant type leads to a benefit for~          the patient.~        2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar~          III Prosthesis under in vivo, weight-bearing conditions during multiple activities~          (gait, stair descent, deep knee bend and chair rise).~        3. To determine if there is a correlation between in vivo kinematic data obtained using~          fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine~          if variability occurs between these two TKA types.~        4. To determine if a clinical benefit is either visibly detected (video camera) or~          quantifiably determined (questionnaire) for either TKA type.~   "
173765|NCT01290627|"~     This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces)~     of participants having a normal knee or a total knee arthroplasty (TKA) using one or two~     different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating~     Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image~     matching technique that will convert a two-dimensional (2D) fluoroscopic image into a~     three-dimensional (3D) image. In conjunction with the fluoroscopic analysis, electromyography~     (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of~     the knee joints. These results will help the orthopaedic community better understand knee~     motion so they can improve testing on existing implants and develop future implants that will~     further enhance patients' lives.~   "
173768|NCT01290588|"~     The purpose of this study is to determine the effect of age and ethnic background on ocular~     aqueous humor dynamics and biometric parameters. Data of normal healthy children and adults~     will be used as controls for future study of juvenile glaucoma, and diabetes and potentially~     for any other condition that affects intraocular pressure in children.~   "
173769|NCT01290575|"~     BMS-820132 is an investigational new drug being developed by BMS for treating Type 2~     diabetes. The purpose of this study is to test the safety/tolerability (potential side~     effects) of multiple doses of the investigational new drug, as well as the amount of study~     drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.~   "
173770|NCT01290562|"~     Patients with new or recurrent spine metastases are currently treated with low doses of~     radiation delivered in up to ten treatments (wide-field radiation therapy). Stererotactic~     body radiotherapy (SBRT) is a technique in which high doses of radiation targeted precisely~     to the metastases to be treated are administered in a small number of sessions, thus reducing~     the radiation damage to the surrounding tissue and areas of the spine.~      The purpose of this study is to evaluate the efficacy of spine SBRT as an alternative to~     conventional radiation for patients with no prior radiation, prior radiation, and in the~     post-operative patient~   "
173771|NCT01290549|"~     This is a Phase I, multicenter, open-label, dose-escalation study of polatuzumab vedotin~     administered as a single agent by intravenous (IV) infusion to participants with relapsed or~     refractory hematologic malignancies. In Phase Ib, participants will receive polatuzumab~     vedotin in combination with rituximab.~   "
173772|NCT01290536|"~     This is a prospective pilot study designed to document safety and efficacy of liver-directed~     therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer~     metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).~   "
173773|NCT01290523|"~     This is a prospective pilot study that will document the clinical experience of 30 patients~     with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90~     glass microspheres (TheraSphere®).~   "
173774|NCT01290510|"~     The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2%~     hyaluronan) in the treatment of painful tendinopathy.~   "
173775|NCT01290497|"~     The main objective is the comparison of three different dosage regimens of hyaluronic acid in~     the treatment of osteoarthritis of the knee.~   "
173776|NCT01290484|"~     There is an unsatisfied medical need for a first-line treatment of lymphatic malformations~     with a good benefit/risk profile. Based on a patient experience in the institution, the~     investigators plan to verify whether or not the medication sildenafil has a beneficial effect~     on lymphatic malformations. The investigators plan to do this by treating patients with~     lymphatic malformations with the medication sildenafil for a 20 week period. This is an~     investigator initiated study funded by an Innovations in Patient Care grant and a SPARK~     grant.~   "
173777|NCT01290471|"~     This is a Phase 1, open label study to assess the safety and tolerability of U3 1565,~     determine maximum tolerated dose (MTD) or establish maximum administered dose (MAD) safety~     and tolerability.~   "
173778|NCT01290458|"~     Consumption of vitamin supplements is a common practice among athletes or people~     participating in health promoting exercise programs. The reason for this interest in vitamin~     supplements is primarily because of the observation that enhanced production of reactive~     oxygen and nitrogen species (RONS) influence fundamental biological processes, such as gene~     expression, signal transduction and enzyme activity. In a muscle and exercise physiology~     context, a low level of RONS is required for normal force production, whereas marked~     increases in RONS can cause contractile dysfunction, resulting in muscle weakness and~     fatigue. On the other hand RONS are involved in signaling pathways and serve to up-regulate~     the expression of a number of genes and can exert favorable effects such as training~     adaptations.~      The present study will employ a valid eccentric exercise model to examine the influence of~     combined vitamin C and E supplementation after acute and chronic eccentric exercise on muscle~     damage and performance, redox status, hemolysis and lipid and lipoprotein profile.~   "
173779|NCT01290445|"~     A prospective population-based cohort study to examine whether varenicline use during~     pregnancy is associated with an increased risk of major congenital malformations in infants~     above that associated with smoking during pregnancy.~   "
173780|NCT01290432|"~     Dr. Roseff and his colleagues are conducting a study to evaluate the effectiveness of a novel~     substance (Inofolic Plus®) in improving oocyte (egg) parameters in subfertile female~     patients, as measured through Anti-Mullerian Hormone (AMH) blood levels.~   "
173781|NCT01290419|"~     A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to~     Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in~     healthy adults (18 to 49 years of age).~      Study Objectives:~      Primary:~        -  To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein~          particle vaccine formulations.~      Secondary:~        -  To assess and compare the immunogenicity (neutralizing antibody and total anti-F~          antibody) of the 6 RSV-F protein particle vaccine formulations~        -  To confirm the dose sparing and value added effects of the aluminum phosphate~          adjuvant~   "
173782|NCT01290406|"~     This is an open label and single arm study to investigate the safety and efficacy of BEZ235~     in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or~     after first-line antineoplastic treatment for advanced endometrial carcinoma.~   "
173783|NCT01290393|"~     This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and~     other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual~     period between 30 days before and 90 days after any dose of CERVARIX, when compared to a~     Non-exposed vaccinated cohort, i.e. women with last menstrual period between 120 days and 18~     months after the last CERVARIX or GARDASIL dose.~   "
173784|NCT01290380|"~     The purpose of this study is to evaluate the potential inhibitory effects of ASA404 on~     CYP1A2, CYP2C9, CYP3A4 and CYP2C19 mediated metabolism on the respective probe drugs~     caffeine, diclofenac, simvastatin, and omeprazole, respectively. This will be accomplished by~     the simultaneous administration of four substrates as part of a cocktail in order to~     characterize the potential for in-vivo drug-drug interactions. This cocktail approach has~     been proposed per FDA guidance as a screening tool for potential in-vivo drug-drug~     interactions Compared to the individual administration of specific probes in multiple~     studies, simultaneous administration of multiple in-vivo probes of drug-metabolizing enzymes~     offer several distinct advantages such as minimizing the confounding influence of~     inter-individual and intra-individual variability over time. Substrates for the CYP enzymes~     were chosen based on the FDA guidance recommendations taking into account that 1. The~     substrates are specific for the individual CYP enzymes, 2. There are no interactions among~     these substrates; and 3. The study will be conducted in a sufficient number of subjects.~   "
173826|NCT01289834|"~     The purpose of this scientific study is to compare early migration of hip prostheses in~     respect to the bone in order to determine whether there is a clinical difference between the~     two investigated bone cements (which one is best suited for cementation of hip prostheses).~   "
173785|NCT01290367|"~     The purpose of this study is to compare two doses of immunoselected, culture-expanded,~     nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control~     intradiscal injections in subjects with chronic low back pain due to moderate Degenerative~     Disc Disease (DDD) at one lumbar level from L1 to S1.~      All investigational subjects in this study will undergo injection of either 6 million (M) or~     18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus.~     All control subjects will undergo an intradiscal control injection with either saline or~     hyaluronic acid only~   "
173786|NCT01290354|"~     The purpose of this study is to find out how much lapatinib can enter both normal brains and~     brains in which tumours secondary to breast cancer have developed.~   "
173787|NCT01290341|"~     This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group~     Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the~     treatment of tinea pedis.~   "
173788|NCT01290328|"~     The primary purpose of this study is to determine the effect of Epoetin Alfa (Procrit) on the~     change in hemoglobin (red blood cell count) in anemic kidney transplant recipients. The~     investigators hypothesize that epoetin alfa will raise hemoglobin.~   "
173789|NCT01290315|"~     The purpose of this study is to compare safety and the oxidative stress potential of two~     doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single~     dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA)~     in female subjects.~   "
173790|NCT01290302|"~     The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and~     subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of~     subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.~   "
173791|NCT01290289|"~     To compare combined spinal epidural, epidural and IV pethidine analgesia and their effects on~     the mother, fetus, newborn and the course of labor.~   "
173792|NCT01290276|"~     The goals of this open-label Phase Ia study are to evaluate the Pharmacokinetics (PK)~     profiles of new novel single-dose Ondansetron Pulsatile Release (Ond-PR) formulations in~     normal healthy volunteers. After this initial phase, the investigators will follow with the~     Phase Ib study to determine Pharmacokinetic/Pharmacodynamic (PK/PD), safety, and tolerability~     interactions following simultaneous administration of these ondansetron formulations with a~     10 mg Methylphenidate Immediate Release (MPh-IR) tablet in normal healthy volunteers.~   "
173793|NCT01290263|"~     Primary Objectives~      Cohort A ‐‐ monotherapy:~      To determine the efficacy of AMG 386 in participants with recurrent glioblastoma (GBM) as~     measured by 6‐month progression‐free survival (PFS6)~      Cohort B - combination therapy:~      Phase I To determine the maximum tolerated dose of AMG 386 in combination with bevacizumab~     given at 10mg/kg every 2 weeks in participants with recurrent glioblastoma.~      Phase II To determine the efficacy of AMG 386 plus bevacizumab in participants with recurrent~     glioblastoma (GBM) as measured by 6‐month progression‐free survival (PFS6).~      Secondary Objectives:~      To evaluate radiographic response in both cohort populations. To evaluate overall survival in~     both cohort populations. To assess time‐to‐progression in both cohort populations. To~     investigate the safety profile in both cohort populations.~      Exploratory Objectives:~      To evaluate expression of factors associated with tumor angiogenesis using a multiples~     cytokine assay among participants undergoing therapy with AMG 386 with response to therapy~     and development of resistance.~      This is an open‐label Phase I/II study of AMG 386 monotherapy and AMG 386 in combination with~     bevacizumab. Two cohorts will accrue and will be assessed sequentially. Each cohort will~     enroll participants with recurrent GBM. Cohort A will assess recurrent GBM participants who~     receive AMG 386 monotherapy at 30 g/kg every week. (Cohort A initially accrued at a dose of~     15mg/kg, but this was increased to 30 mg/kg every week following an amendment). Cohort B will~     assess recurrent GBM participants who receive weekly AMG 386 plus bi‐weekly bevacizumab~     (10mg/kg). Cohort B will start with a Phase I component to determine the MTD of AMG 386 that~     is safe when used in combination with bevacizumab. AMG 386 is administered intravenously,~     and, when used in combination with intravenous bevacizumab, will be administered first.~      Patients will be required to come to the clinic weekly for study drug administration.~      For study purposes, a cycle of therapy will be 4 weeks. Treatment will continue until either~     evidence of progressive disease, unacceptable toxicity, non‐compliance with study follow‐up,~     or withdrawal of consent.~      The estimated rate of accrual is 60 participants per year. The estimated date of accrual~     completion is 1.5 years from study initiation. The estimated date of study completion will be~     approximately 12 months from enrollment of the last study participant.~   "
173794|NCT01290250|"~     The purpose of this study is to evaluate the effects of a new orange juice-based beverage~     enriched in fiber and selected phenolic compounds (mainly flavanones) on features of~     metabolic syndrome and cardiovascular disease risk factors related to inflammation and~     antioxidant defense system in overweight and obese adult humans. This study hypothesizes that~     consumption of an orange juice-based beverage enriched in fiber and selected phenolic~     compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure~     and the Homeostatic Model Assessment (HOMA) index.~   "
173795|NCT01290237|"~     Vancomycin is an antibiotic administered to children or adults for many types of infections.~     While it has been used to treat infections of children for more than 50 years we are still~     not completely certain about the best dose to use when starting treatment with this~     medication.~      This study is intended to evaluate whether giving a new higher dose of vancomycin for the~     first dose will help us get to the desired amount in the body more quickly then the usual~     first dose. Half of the patients would get the new higher dose and the other half of patients~     will get the typical first dose. Only the first dose is changed and all doses that follow are~     the same in both groups and are doses typically used for children.~   "
173796|NCT01290224|"~     RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by~     chemotherapy.~      PURPOSE: This phase II trial is studying how well MC5-A scrambler therapy works in reducing~     peripheral neuropathy caused by chemotherapy~   "
173797|NCT01290211|"~     This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of~     14 healthy male and/or female subjects, to estimate the effect of maraviroc on the~     pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the~     pharmacokinetics of maraviroc.~   "
173798|NCT01290198|"~     The objective of this proof of concept study is to assess the involvement of~     epoxy-eicosatrienoic acids (EETs) in post-occlusive hyperemic and thermal hyperemia~     responses, and the interaction between nitric oxide (NO) and EETs, using the latest methods~     for the study of functional microcirculation.~   "
173827|NCT01289821|"~     This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when~     given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with~     metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an~     oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets~     certain key proteins that are essential for the survival of the cancer cell. By specifically~     targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be~     decreased by preventing these specific proteins from functioning.~      The primary endpoint (the most meaningful result to be tracked) of this study is based on the~     rate of response, i.e. the disease getting smaller. The aim is to show that the therapy of~     colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate~     observed for the standard therapy only.~   "
173799|NCT01290185|"~     Major orthopaedic surgery is painful and requires safe and effective postoperative analgesic~     therapy. The successful use of continuous peripheral nerve blocks provides sustained~     analgesia while minimizing the need for opioid analgesics throughout the postoperative period~     and avoiding the side effects associated with central neuraxial techniques. Excellent~     analgesia can be maintained and opioid-related side effects avoided allowing improved~     rehabilitation. However using existing methods a failure rate of >20% significantly limits~     the analgesic benefits in a substantial proportion leading to uncontrolled pain and side~     effects of opioid analgesics.~      A major concern with the use of continuous peripheral nerve blocks is difficulty in placement~     of the catheters close enough to the nerve to allow for effective local anaesthetic spread~     and therefore analgesia. The benefit of ultrasound to precisely place needles adjacent to~     nerves and increase efficacy of block success is undisputed. However ultrasound is of less~     help in accurately placing catheters. Indeed the final position of the catheter tip is not~     predictable and can be inadequate in 10%-50% of cases. The explanation for that is the~     material in currently used catheters is stiff and designed to avoid kinking. Unfortunately~     this same stiffness often leads to inadequate placement of the catheter tip. We have~     developed a catheter which coils up as soon as it is advanced beyond the needle tip, thus~     allowing the catheter tip to remain close to the initial needle tip position and therefore~     the nerve. The aim of this prospective randomized double blind controlled study is to~     determine the effectiveness of this new catheter in comparison with standard of care methods~     for continuous femoral nerve block commonly used after total knee arthroplasty. The primary~     outcome measure will be the incidence of catheter related block failure 24 hours after~     surgery. Our hypothesis is that the coiled catheter will significantly improve the efficacy~     of continuous femoral nerve block as compared to existing techniques.~   "
173800|NCT01290172|"~     This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to~     evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver~     transplantation. Patient systemic and hepatic dynamics will be collected and recorded at~     predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to perform~     liver biopsies at two different time-points to compare the liver structure and proteomic~     variations.~   "
173801|NCT01290159|"~     Today, the level of tolerance to heat is based on physiological strain indices, with no~     correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the~     formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling~     pathophysiology related to hyperthermia, can be used to identify tolerance/intolerance to~     heat. The aim of the present project is to develop a simple assay, based on specific designed~     sensitive biomarkers of OS that can be detected in a small blood sample, and to possibly~     correlate each individual's state of tolerance to heat to the level of OS. These biomarkers~     specially designed and synthesized to form a novel probe (not present as such in biological~     organs). The method will be based on the incubation of the suggested biomarkers with the~     patient's blood sample and the measurement of the level and type of oxidative alteration of~     the markers. For this goal, post heat stroke patients, with different levels of tolerance to~     heat and subjects during a process of acclimation to heat will be studied. Such a method will~     add to our ability to better determine the level of tolerance to heat and not rely only on~     the measurements of temperature and heart rate during an exercise-heat stress.~   "
173802|NCT01290146|"~     The purpose of this study is to compare in patients with Advanced Chronic Heart Failure the~     effects of Levosimendan versus diuretic (single 24-hour infusion) applied at the early~     detection of impending destabilization on hospitalization-free survival during 12 months.~      Patients with advanced chronic heart failure (ACHF) have a short term reduced life expectancy~     with recurrent hospital admissions for clinical exacerbations. Levosimendan improves~     contractility by calcium-dependent binding to troponin C, determines vasodilation of the~     coronary arteries and systemic resistance vessels, thus decreasing preload and afterload,~     while exerting a protective effect on the myocardium against ischemia-reperfusion damage. In~     randomized clinical trials of acute heart failure patients, levosimendan improved~     hemodynamics and patients' quality of life and decreased natriuretic peptide plasma levels,~     with no excess mortality The study will assess whether the administration of levosimendan~     (single 24-hour infusion) at the early detection of deterioration may reduce frequency and~     duration of hospital admissions, improve functional status and quality of life in ACHF~     patients, with respect to diuretic infusion.~   "
173803|NCT01290133|"~     The purpose of this study is to describe the safety and tolerability and pharmacokinetics of~     a single intravenous administration of the new, Sulfobutyl Ether-7-Beta-Cyclodextrin~     (Captisol™) based, formulation in Healthy Adult Subjects.~   "
173804|NCT01290120|"~     The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy~     combination programme originally introduced by GMALL (the German cooperative group for adult~     acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free~     survival rates of adult patients with Burkitt's leukemia and lymphoma.~      The therapy includes a maximum of six chemotherapy courses (two with high doses of~     methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses),~     supplemented by local radiation therapy in the case of initial mediastinal or central nervous~     system (CNS) involvement or a residual tumor after chemotherapy.~   "
173805|NCT01290107|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at bone marrow samples from patients with acute~     myeloid leukemia.~   "
173806|NCT01290094|"~     This single arm, open label study will assess the efficacy and safety of and compliance to~     treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with~     post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg~     intravenously every three months. Anticipated time on study treatment is 12 months with a~     follow-up of 12 months.~   "
173807|NCT01290081|"~     The purpose of this study was to determine the prevalence of latent tuberculosis infection~     among injecting drug users and to conduct randomized controlled trial to evaluate a case~     management intervention aimed at increasing TB screening and treatment entry among injecting~     drug users referred from a methadone drug treatment program in Estonia.~   "
173808|NCT01290068|"~     The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR®~     +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.~   "
173828|NCT01289808|"~     Glucose has analgesic and calming effects in newborns. To date, it is not known whether the~     beneficial effects extend to care giving procedures that are performed after painful~     procedures. The investigators objective is to determine the effect of glucose 25% analgesia~     for procedural pain on infant pain responses during a subsequent care giving procedure.~   "
173829|NCT01289795|"~     The purpose of this study is to determine whether levels of circulating endothelial~     progenitor cells (cEPC) are increased in the acute phase of ischemic stroke.~   "
173809|NCT01290055|"~     The yellow fever vaccine is a live, attenuated virus that results in a robust immune~     response, especially in the T cell compartment. We have been studying immune responses to~     live viral infections using the yellow fever vaccine as a model for a live viral infection.~     In this study, we are interested in looking at the processing and lifespan of yellow fever~     specific CD8 T cells.~      We plan to accomplish this by measuring DNA replication and cell proliferation in humans~     using a naturally occurring stable isotope called deuterium (D20). This technique has been~     used to track the turnover of a number of human cell types in vivo. We plan to use D20~     labeling to track YFV specific CD8+ T cells in human vaccinees who are positive for a~     specific HLA type, HLA A202.~      Deuterium labeled water (D2O), also known as heavy water is physically and chemically very~     similar to ordinary drinking water. In water, two hydrogen atoms bond to an oxygen and create~     H20. However in deuterated water, deuterium atoms replace the hydrogen atoms. Deuterium is a~     form of hydrogen that has an extra neutron. This neutron gives the atom extra weight, hence~     the name heavy water. This extra weight can be detected in the lab with very sensitive~     instruments. Scientists have been using heavy water as a tracer to gain a better~     understanding of animal and human metabolic rates. Deuterium is in fact already in the water~     we drink daily. It is not radioactive, and it occurs naturally at a concentration of about 1~     part per 5,000. Researchers have used heavy water since 1934 as a safe and effective tool in~     clinical trials.~   "
173810|NCT01290042|"~     To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy~     subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's~     disease.~   "
173811|NCT01290029|"~     The primary objective of the study was to evaluate the safety and tolerability of cinacalcet~     after a single oral dose in children aged 28 days to less than 6 years with chronic kidney~     disease receiving dialysis.~   "
173812|NCT01290016|"~     Children who are overweight or obese can develop many health complications including~     diabetes, high blood pressure, high cholesterol and they break their bones more often than~     children who are of healthy body weights. Recent short-term studies in children suggest that~     increasing milk intake for 16 weeks begins to improve body composition and also reduces risk~     of developing diabetes. However, no study has been long enough to truly test for the benefits~     of high milk consumption on these conditions including bone. Both dietary and activity~     approaches to reducing obesity in children are suggested by health professionals and when~     combined are called lifestyle interventions. Therefore, McGill University has designed a~     1-year intervention study focused on lifestyle improvements to reduce obesity in children 6~     to 12 years of age. A control group will be monitored for the year, while two other groups~     will receive lifestyle interventions with standard recommended (2 servings a day) and high (4~     servings a day) intakes of milk. The intervention will include 6 planning sessions to~     increase intakes of vegetables, fruits and milks along with more activity and less time~     watching television or using computerized games. Children will have muscle and fat measured~     using an x-ray device that also measures bone at the beginning, middle and end of the study.~     They will also have a small blood sample taken every 3 months to measure blood sugar,~     cholesterol and some nutrients. Changes over the study will demonstrate the benefits of~     lifestyle and milk interventions.~   "
173813|NCT01290003|"~     The purpose of the study is to evaluate the role of antibiotics in preventing infection in~     babies born through meconium stained amniotic fluid. Normally babies do not pass meconium~     while in utero. In response to hypoxic stress babies may pass meconium before birth and are~     likely to be candidates for problems related to meconium passage and its inhalation. It is~     believed that these babies are more prone to infections as meconium enhances bacterial growth~     and may predispose such babies to secondary bacterial infections. In addition, meconium~     passage has been incriminated as a pointer of in-utero infection. Whether use of antibiotics~     in babies born through meconium stained amniotic fluid will reduce the infectious episodes~     and complications thereof or not is not clear. Moreover, there is not much published~     literature to prove or refute the same. Most clinicians have a low threshold for using~     antibiotics in such babies. In view of the uncertainty regarding antibiotic usage in these~     babies, the investigators decided to investigate the role of prophylactic antibiotics in~     prevention of neonatal sepsis in babies born through meconium stained amniotic fluid.~   "
173814|NCT01289990|"~     This study will investigate the efficacy and long term safety and tolerability of BI 10773 in~     type 2 diabetic patients.~   "
173815|NCT01289977|"~     Sand flies can carry the infection leishmaniasis (a parasite). The purpose of this study is~     to evaluate the human immune response to uninfected laboratory raised sand fly bites and~     select from the immune response to sand fly saliva, possible substances to use for a future~     vaccine to protect against the parasite leishmaniasis.~   "
173816|NCT01289964|"~     The study aims to investigate the influence of 5 dry cupping treatments on chronic non~     specific neck pain. 50 patients with neck pain are randomised into cupping treatment and~     waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck~     pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the~     quality of life (SF36). To investigate neurophysiological effects of cupping we also measure~     mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain~     threshold (PPT) at pain related and control areas. The treatment group then receives 5~     cupping treatments over a period of two weeks. After the cupping series resp. a waiting~     period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated~     (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by~     the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping~     treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to~     changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.~   "
173830|NCT01289782|"~     The purpose of this study is to investigate the effectiveness and safety of TMC435 compared~     with placebo in participants who are infected with genotype 1 hepatitis C virus who have~     never received treatment before. Participants will also receive peginterferon alpha-2a and~     ribavirin as part of their treatment.~   "
173831|NCT01289769|"~     The purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic~     responses during laryngoscopy and double lumen endotracheal intubation and assess the adverse~     effect related to complications of dexmedetomidine.~   "
173817|NCT01289951|"~     Raltegravir is the first integrase inhibitor used in humans. It has been shown to be highly~     efficacious and well tolerated in phase III clinical trials in multidrug experienced human~     immunodeficiency virus(HIV)-infected patients, as well as initial therapy in untreated~     patients. Pharmacokinetic studies in healthy adult subjects indicate that the major mechanism~     of clearance of the drug is glucuronidation mediated by UGT1A1, with a minor contribution of~     renal excretion of unchanged parent compound. Unlike CYP-based metabolism, glucuronidation is~     generally found to be relatively unaffected by hepatic disease. A single dose pharmacokinetic~     study of raltegravir in patients with mild to moderate hepatic insufficiency (Steigbigel et~     al. 2008) found no clinically important effect on the drug pharmacokinetic profile, with no~     dosage adjustment being necessary. The liver safety and tolerability of boosted atazanavir~     (ATV/r) has been evaluated in human immunodeficiency virus and hepatitis C virus (HIV/HCV)~     coinfected patients with advanced liver disease (decompensated cirrhosis) (Hermida JM et al.~     4th IAS: Sidney, 2007). Similar to Raltegravir, ATV is also mainly metabolized by conjugation~     through UGT1A1. There is an urgent need for potent and efficacious ARV drugs with a clean~     safety liver profile even in patients with severe liver disease. The investigators~     hypothesized that pharmacokinetics will not be altered in HIV/HCV patients with advanced~     (Child-Pugh grade C) cirrhosis or in those with no histologic liver damage.~   "
173818|NCT01289938|"~     Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and~     Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to~     polymorphisms of CYP2D6~   "
173819|NCT01289925|"~     Serum levels of inflammatory mediators increase with age and are strongly associated with the~     most common and the most devastating health conditions found in older adults including~     frailty, chronic disease, disability and increased mortality. Even though the processes that~     contribute to increased inflammatory mediators are likely not completely reversible in older~     adults, the development of a safe and effective intervention that modulates inappropriate~     inflammatory responses could be a very important component of prevention against frailty and~     other adverse health outcomes. As part of an ongoing effort to identify molecular and~     physiologic triggers of inflammation in older adults, the investigators recently identified a~     highly significant inverse relationship between the anti-oxidant micronutrient selenium and~     the inflammatory mediator IL-6, as well as a significant relationship between selenium and~     all cause mortality in a population of community dwelling older women with selenium levels~     well below the mean for the overall American population. Based on our findings in older~     adults and on data from other studies that suggest that selenium interventions are effective~     in targeted populations with inflammatory conditions, the investigators hypothesize that~     selenium supplementation targeted to a population of older adults with increased inflammatory~     markers and low normal selenium levels will in the short term reduce inflammation as measured~     by serum IL-6, and in the long term will reduce the incidence and prevalence of inflammation~     associated poor health outcomes of frailty, disability, and mortality in vulnerable older~     adults.~   "
173820|NCT01289912|"~     Tuberous Sclerosis Complex (TSC) is a multi-system disease, usually presenting with seizures,~     mental retardation and autism, and exhibiting a high variability in clinical findings both~     among and within families. Investigators are doing research in order to identify possible~     neurocognitive benefits from treatment with RAD001 or placebo for a six month period. There~     may also be potential for improvements in seizure frequency, sleep and autistic behaviors. We~     hope this trial will lead to a better understanding of TSC and to new forms of treatment, to~     benefit children and adults with TSC in the future.~      Individuals diagnosed with TSC will be asked to participate in this study if they are between~     the ages of 6 and 21 years of age and have an IQ of greater than or equal to 60. Both males~     and females will be asked to participate. Additionally, to be eligible for study~     participation, individuals must have been on the same seizure medication(s), if applicable,~     for at least 6 months. Individuals must also be able to participate in neuropsychological~     testing and meet certain medical criteria. They will need to sign an informed consent. If~     enrolled in the study, participants will have a number of screening tests to help determine~     if they are eligible for participation in the clinical trial. If eligible for the treatment~     phase of the trial, they will be asked to take either the study drug or a placebo (pill with~     no medicine), which is determined by chance.~      The study involves about 9 visits, 3 of which can be done locally, over a six month period,~     as well as follow-up calls with our research nurse. Study visits will vary in length.~     Screening, three month and six month visits may last up to 8 hours, while all other visits~     will be less than 2 hours. The study visits include blood draws, laboratory tests and~     neuropsychological assessments. There is no fee to participate in this study. The study drug~     will be provided at no charge during the study.~      After all study data has been analyzed, families will be informed of the overall results.~     Treatment on this study may or may not improve a child's learning skills (neurocognition).~     Future patients may benefit from what is learned.~   "
173821|NCT01289899|"~     The objective of this study is to determine the safety and tolerability and to determine the~     Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in~     healthy male subjects.~   "
173822|NCT01289886|"~     The objective of this study is to determine the safety and tolerability and to determine the~     Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in~     healthy male subjects.~   "
173823|NCT01289873|"~     The purpose of this study is to determine how common oral HPV infections are in college~     women. The investigators also will find out what risk factors are associated with having oral~     HPV infections. The investigators hypothesize that approximately 3% of women will have oral~     HPV, and that HPV will be associated with oral sexual behaviors and with smoking behaviors.~     Finally, for those women with oral HPV- the investigators will determine whether the~     infections are persistent (still present) at 3-, 6-, and 12-months after the initial~     diagnosis.~   "
173824|NCT01289860|"~     This study was a controlled, cross-over, acute flavonoid intervention trial with younger and~     older adults. Subjects consumed a blueberry beverage during one visit and a control beverage~     on another. Cognitive function pre drink was assessed, blood and urine samples were taken as~     well as blood pressure and a measure of vascular reactivity. These outcome measures were~     taken at 2 and 5 hours post drink.~      It was predicted that the flavonoids in the blueberry drink would lead to improved~     performance on the cognitive tests and vascular reactivity measure compared to following the~     control drink. It was thought this could be due to increased vaso-dilation and improving~     blood flow to the brain which was investigated in an extension to the project where a sample~     of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a~     control drink.~   "
173825|NCT01289847|"~     The main objective is to determine the efficacy of Gammaplex by measuring the number of~     serious acute bacterial infections during treatment with Gammaplex over a 12 month period.~     The secondary objectives are to assess the safety and tolerability of Gammaplex and to~     compare the data collected from adult subjects with PID from the GMX01 study~   "
173836|NCT01289704|"~     Charcot−Marie−Tooth neuropathy type 1A (CMT1A) is one of the most common inherited~     neurological disorders. The study will evaluate the efficacy and safety of an innovative~     rehabilitation protocol constituted by exercises at the treadmill and by a stretching and~     proprioceptive approach. A total of 92 patients will be enrolled in the study and treated in~     a controlled, randomized, single blind, way. To recruit a high number of patients with CMT1A~     the study will be multicentric and will comprehend four of the most active clinical centers~     in the field of CMT, in Italy. People with CMT1A are very motivated in entering~     rehabilitation protocols because to date there is no effective therapy for this disease.~     Therefore, the investigators expect a high compliance by the patients. With the present~     project the investigators plan to clarify several unanswered questions: 1) the efficacy and~     safety of treadmill over a more conventional protocol; 2) the duration and frequency of any~     rehabilitation treatment; 3) the most sensitive outcome measures to evaluate the efficacy of~     rehabilitation approach in patients with CMT.~   "
173837|NCT01289691|"~     Patients scheduled for lung lobe resection using video assisted thoracic surgery will be~     randomly assigned to be ventilated with either only oxygen or a mixture of air and oxygen.~      The primary purpose of this study is to determine if the incidence of postoperative collapse~     (in the non-surgical lung) is decreased when using a mixture of air and oxygen compared to~     using only oxygen (which is our control measurement) during one-lung ventilation.~   "
173838|NCT01289678|"~     Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment~     during lymphocyte recovery.~   "
173839|NCT01289665|"~     The purpose of this study is to determine if lubricating gel affects patients' perception of~     discomfort during speculum insertion, as compared to water.~   "
173840|NCT01289652|"~     The aim of the study is to investigate the epidemiology, natural history and treatment~     outcomes of acute hepatitis C (HCV) infection. Given the current pattern of case reporting,~     the cohort will be largely made up of human immunodeficiency virus (HIV)-positive patients,~     but HIV-negative patients with acute hepatitis C (AHC) will also be enrolled to enable~     comparisons to be made as appropriate and possible.~   "
173841|NCT01289639|"~     The study is designed to investigate the relationship between insulin resistance and~     non-alcoholic fatty liver disease (NAFLD) and to investigate potential mechanisms underlying~     insulin resistance in NAFLD by determining associations between hepatic and peripheral~     insulin sensitivity, hepatic steatosis, dyslipidemia, inflammatory cytokines, glucose~     metabolism, beta-cell function and body fat distribution.~   "
173842|NCT01289626|"~     The research question and primary aim is to determine if lanthanum carbonate is effective in~     treating calciphylaxis by measurement of complete or partial remission of skin lesions.~     Secondary endpoints will be measured to determine if lanthanum carbonate can lower~     calcium-phosphorus product levels, intact PTH and mortality. Albumin levels will be measured~     as a marker of nutritional status and inflammation.~   "
173843|NCT01289613|"~     BIS for monitoring depth of anesthesia is usually obtained unilaterally. Obtaining BIS~     bilaterally revealed side differences in previous studies. This study investigates the~     incidence of clinically relevant side differences of BIS during maintenance and emergence~     from anesthesia for ENT surgery in both adults and children.~   "
173844|NCT01289600|"~     The purpose of this study is to demonstrate that mechanical ventilation guided by the~     diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior~     compared to pressure support and pressure control ventilation.~   "
173845|NCT01289587|"~     The aim of this study is to evaluate the effects of a physical activity intervention in~     patients with type 2 diabetes in a community setting.~   "
173846|NCT01289574|"~     To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice~     daily for facial acne compared to vehicle control.~   "
173847|NCT01289561|"~     The purpose of this study is to investigate the effects of caffeine on the~     self-administration of alcohol. The study will also examine the combined effects of alcohol~     and caffeine on behavioral performance, participant ratings of behavioral performance, and~     self-reported subjective effects.~   "
173848|NCT01289548|"~     The purpose of this study was to investigate whether lower limb ischaemic preconditioning can~     improve renal function in patients undergoing living donor kidney transplantation~   "
173849|NCT01289535|"~     This study is the first step in a clinical research program that aims to study the immune~     response to influenza vaccine in the elderly and then to propose a new method of~     administering the vaccine.~      Influenza can cause severe complications in patients at risk (elderly and subjects vulnerable~     because of a chronic underlying disease). Over 90% of deaths related to influenza occur in~     people aged over 65 years.~      Vaccination is the most effective way to prevent infection. The World Health Organization~     recommends annual immunization for people at risk, including all persons aged over 65 years,~     to reduce the risk of morbidity and mortality related to influenza.~      However, the immune response to influenza vaccine appears to be lower in elderly than in~     young people.~   "
173850|NCT01289522|"~     PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line~     treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas.~     Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck~     cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination~     named TPEx as first-line treatment in this setting.~   "
173851|NCT01289509|"~     The purpose of this study is to evaluate the relative bioavailability (BA) of two lots of~     E5501 40 mg tablets administered twice as single oral doses to healthy subjects.~   "
173852|NCT01289496|"~     Patients for whom treatment with peginterferon plus ribavirin was unsuccessful represent a~     category of patients for whom there is currently no worthwhile therapeutic alternative.~      Several studies have shown that there is a relation between plasma ribavirin concentrations~     and treatment response. Adequate ribavirin plasma concentrations, especially during the first~     12 weeks of treatment, should be associated with a better chance of response to the~     treatment.~      The strategy for this study will be to use a loading dose of ribavirin before beginning the~     treatment with peg-interferon, thereby allowing for optimal ribavirin concentrations to be~     reached, and possibly improving the effectiveness of the treatment.~   "
173853|NCT01289483|"~     Patients scheduled for awake fiberoptic intubation (AFI) because of potential difficult~     airway will be consented prior to intubation ASA Physical Status classification and history~     of difficult intubation will be recorded at screening. The investigators will also record the~     results of airway examination including Mallampati classification, thyromental distance,~     mouth opening, neck circumference, neck range of motion, presence or absence of beard and~     overbite, history of neck radiation, and mandibular protrusion test Informed consent will be~     obtained prior to the procedure from those patients who meet the inclusion and exclusion~     criteria.~      Standard hemodynamic monitoring will be used in all patients including EKG, blood pressure,~     heart rate, respiratory rate and oxygen saturation. Modified Observer's Assessment of~     Alertness/Sedation (MOAA/S) scale will be used to assess the level of alertness/sedation. Two~     consecutive MOAA/S scores of 4 will be considered as the desired effect of moderate sedation.~      For AFI procedure, IV will be started and oxygen will be administered. 4 L of oxygen will be~     delivered through nasal canula until the completion of the AFI procedure. Patient head will~     be positioned in the sniffing position, Topical anesthesia would be achieved using the~     topical administration of 4 percent lidocaine using atomized and MaDgic nebulizer, and 2%~     xylocaine Jel applied to the surface of Williams airway in a total dose of lidocaine not~     exceeding 10 mg/kg. Patients will be randomized to one of the four fospropofol treatment~     arms: 2, 3.5, 5, or 6.5 mg/kg~   "
173854|NCT01289470|"~     An observational study designed to evaluate the performance of a new Near Infrared~     Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral~     sensor and peripheral sensor. Fifty patients who are undergoing open-heart surgery will be~     enrolled and tissue oximetry measurement will be collected throughout the surgical procedure~     and for up to 24 hours following surgery. Tissue oximeter measurement of the brain and~     skeletal tissue will be added to the standard intra-operative patient monitoring. Measures of~     delirium will be collected using a standardized questionnaire. The relationship between~     cerebral oximetry measures and delirium scores will be explored.~   "
173855|NCT01289457|"~     The goal of this clinical research study is to learn if the combination of clofarabine,~     idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can~     help control AML and MDS. The safety of these study drug combinations will also be studied.~   "
173856|NCT01289444|"~     Our goal is to advance palliative care to adolescents and their families. We hope our study~     will decrease suffering (psychological, spiritual, physical) and increase quality of life~     (QOL). Left unprepared for end-of-life decisions, miscommunication and disagreements may~     result in families being charged with neglect or court battles over treatment choices. FAmily~     CEntered (FACE) Advance Care Planning helps prepare adolescents with HIV/AIDS and their~     families for future medical decisions. We hope to increase families' understanding of their~     teens' wishes for end-of-life care and to decrease conflict. We will also study communication~     and spiritual struggle Families will be randomized into the either the Control (N=65~     families) or FACE Intervention (N=65 families). FACE families will meet with a~     trained/certified researcher for three 60- to 90-minute sessions scheduled one week apart:~     Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session 2:~     The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control families~     will also meet with a researcher for three 60-to 90-minute sessions scheduled one week apart:~     Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Nutrition.~     Questionnaires will be administered five times, when first seen, at 3, 6, 12 and 18 months~     from the time of Session 3. Hypothesis 1: Compared to an active control, FACE will relieve~     psychological suffering by 1) increasing congruence in treatment preferences between teens~     with AIDS and their surrogates, 2) decreasing decisional conflict regarding EOL decision~     making for future medical treatment in adolescents with AIDS; 3) increasing quality~     communication about EOL care in adolescent/legal guardian or surrogate dyads; 4) and~     maximizing QOL.~      Hypothesis 2: In addition to the direct effects, FACE will also indirectly affect QOL through~     dimensions of threat appraisal.~      Hypothesis 3: FACE will have stronger effects on the QOL measures among patients who have~     less spiritual struggle.~      Hypothesis 4: Spiritual struggle has both direct and indirect effects on~     hospitalization/dialysis use. FACE will also affect hospitalization/dialysis use indirectly~     through threat appraisal and HAART adherence.~   "
173857|NCT01289431|"~     The objective of this study is to evaluate the dose response, and efficacy of Mapracorat~     ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs~     associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.~   "
173858|NCT01289418|"~     Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or~     drifts, and its safety profile may vary. While generally considered safe, influenza vaccines~     have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) or~     with oculorespiratory syndrome (2001). The emergence of a novel strain of H1N1 influenza~     virus (pH1N1) has prompted health departments worldwide to prepare for mass vaccination~     campaigns with a new H1N1 pandemic vaccine. Following recommendations of the World Health~     Organization (WHO), Canada immunized its population with a dose-sparing adjuvanted vaccine.~     While the adjuvant developed by GlaxoSmithKline (GSK) has been administered to over 39 000~     people, only a few hundred will have been vaccinated with the H1N1 formulation in clinical~     trials before the mass campaign was launched. With this small number, adverse events~     occurring at a rate < 1% will not be detected by these clinical trials.~      Considering that most cases of pH1N1 to date have been relatively mild, it will be imperative~     to rapidly detect adverse events serious enough to reconsider the use of the vaccine. Passive~     surveillance is collecting notifications of adverse events but the sensitivity of this system~     is not high and its timeliness is not necessarily optimal.~      In Canada, healthcare workers (HCW) are among those who were offered the new pandemic vaccine~     in priority. Because they were offered the vaccine early in the campaign and because they~     constitute a well-defined group in good general health, this group of people may be well~     suited for monitoring the safety of the pH1N1 vaccine.~      The main objective of this project was to estimate in HCW vaccinated against pH1N1 the~     frequency of adverse events of sufficient severity to cause work absenteeism or medical~     consultation.~      The active surveillance was done in HCW from 3 sites (Canadian hospitals) participating in~     the Pandemic Influenza Research Network (PCIRN): (1) Halifax (Nova Scotia), (2) Quebec City~     (Quebec): 3 hospitals, (3) Toronto~   "
173869|NCT01289275|"~     When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of~     them, however, go back to smoking soon after discharge. This study will test an innovative~     approach which includes dispensing nicotine patches at discharge, providing proactive~     telephone counseling post discharge, or giving a combination of the two. The interventions~     are aimed at increasing the long term quit rate of these patients.~      The specific aims of the study are to demonstrate the effects of two interventions,~     dispensing nicotine patches at discharge and providing proactive telephone counseling soon~     after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.~   "
173870|NCT01289262|"~     Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology~     Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S~     (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in~     subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies,~     ...) are very important issues. Classically Kerr incision is repaired with continuous locked~     suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in~     turn may reduce short and long term complications. For this reason, the investigators aimed~     to compare two closure techniques.~   "
173859|NCT01289405|"~     Objective: to evaluate the effects of a speech therapy exercises program in the treatment of~     Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography~     (PSG) parameters.~      Methods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index < 35~     kg/m2 and scores of Epworth Sleepiness Scale > 9. Patients will be divided into four groups:~     I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent~     placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent~     speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or~     placebo. The speech therapy include isometric and isotonic exercises to improve posture,~     mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of~     tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck,~     without therapeutic purpose. Both therapies are applied for three months, three times a day,~     lasting 20 minutes each session. During the treatment, the subjects will be monitored in~     weekly meetings, for orientation and description of the exercises and return of the fulfilled~     exercises diary. The subjects will also be followed at the CPAP clinic in returns after one~     week, a month and at the end of the study. Conduct assessments before and after treatment and~     after twenty one days washout, including: assessing the upper airway, anthropometric~     investigation of the facial skeleton and speech of Orofacial, questionnaires (Epworth~     Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring), Psychomotor~     Vigilance Test and PSG.~   "
173860|NCT01289392|"~     Introduction: It is unclear whether exercise training with or without Continuous Positive~     Airway Pressure (CPAP) and Oral Appliance (OA) is more effective in reducing symptoms of~     Obstructive Sleep Apnea (OSA) than treatment solely with CPAP or OA.~      Objective: In patients with moderate OSA, the investigators will evaluate the effect on the~     subjective and objective measures of sleep, quality of life and mood of different forms of~     treatment: exercise training of 4 months; exercise training of 4 months associated with CPAP~     and OA; treatment with CPAP and treatment with OA.~      Material and Methods: Sixty male patients (25-65 years, sedentary lifestyle, Body Mass Index~     (BMI) < 35kg/m2, Apnea-Hypopnea Index (AHI) between 15-30/h, Epworth sleepiness scale > 9)~     will be divided into three groups: CPAP+exercise group (CE; n=20), OA+exercise group (AE;~     n=20), and Exercise training group (E; n=20). The patients in groups CE and AE will complete~     two months of treatment with CPAP or OA to examine the separate effects of these devices. As~     the patients of the E group did not use the CPAP but will undergo four months of exercise~     training. After this initial step, patients in CE and AE groups will undergo four months of~     exercise training associated with CPAP or OA. The investigators will evaluate the subjective~     sleep parameters (sleep disorders questionnaire, the Epworth Sleepiness Scale, sleep diaries)~     and objective (polysomnography), Short Form Health Survey (SF-36), Questionnaire Profile of~     Mood States (POMS) and anthropometric measurements (neck circumference and body composition),~     the incremental exercise test (ergospirometry) and the one Repetition Maximum test (1RM).~   "
173861|NCT01289379|"~     Investigators conducted a randomised perspective study to determine whether the use of HFJV~     instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects~     of pneumoperitoneum during laparoscopic surgery.~   "
173862|NCT01289366|"~     Precise activity assessment of inflammatory bowel disease (IBD) is essential to determine the~     extent and severity of the disease for further specific therapy. Nevertheless, despite~     ongoing developments in the field of gastrointestinal endoscopy, the final diagnosis still~     relies on the interpretation of histopathological features of intestinal biopsies taken~     during the endoscopic examination. Recently, endocytoscopy (EC) was introduced as a new~     endoscopic imaging modality, enabling microscopic imaging within the mucosal layer of the gut~     at a magnification level of up to 1400-fold.~   "
173863|NCT01289353|"~     The purpose of this study is to determine the safety and effectiveness of a combination of~     chemotherapy and radiotherapy in breast cancer patients after breast surgery.~   "
173864|NCT01289340|"~     the aim of the study is to compare between two advanced wound dressing and conventional~     dressing for the primary ER treatment of superficial partial thickness burns~   "
173865|NCT01289327|"~     Although propofol is a popular agent for sedation during flexible bronchoscopy, some~     clinicians have raised concerns that it may cause greater respiratory drive reduction than~     more common drugs. However, this factor is difficult to accurately examine with pulse~     oximetry. The introduction of a novel device that noninvasively measures carbon dioxide (CO2)~     levels can help to resolve this controversy. The aim of this study is to evaluate the safety~     of conscious sedation with midazolam+alfentanil compared to propofol.~   "
173866|NCT01289314|"~     Objective: To compare the occurrence and intensity of pelvic pain as well as patient~     satisfaction and quality of life after total laparoscopic and laparoscopic supracervical~     hysterectomy.~      Design: Prospective randomised trial.~      Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic~     pain following TLH compared with following LSH.~      Null hypothesis 2: There is no significant difference in patient satisfaction and quality of~     life following TLH compared with following LSH.~   "
173867|NCT01289301|"~     Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to~     graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study~     the best way to manage viral invasion by changing the immunosuppressive treatment comparing~     two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme~     is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study~     will be performed as a prospective, randomized, parallel group comparison.~   "
173868|NCT01289288|"~     The objective of this study is to test whether a culturally-tailored in-office based~     intervention have impact on increasing Chinese physician's recommendation of colorectal~     cancer (CRC) screening to their nonadherent Chinese patients.~      Special aims are to:~        1. Evaluate the efficacy of a culturally-tailored physician intervention on increasing~          non-adherent Chinese American's patients' CRC screening rate.~        2. Identify factors that mediate or moderate the intervention effects. For example,~          patients who hold an eastern cultural view or are less acculturated will be more likely~          to benefit from the intervention than patients who hold a western view or who are more~          acculturated.~   "
174591|NCT01279785|"~     This is a single arm, open label study of up to 20 patients with prostate cancer scheduled~     for prostatectomy at the NIH Clinical Center. 123I-MIP-1072 image data will be evaluated for~     visible uptake and compared with histopathology.~   "
173871|NCT01289249|"~     The object of the study is to investigate whether all included patients receive treatment~     that is effective against all bacteria that are defined as sensitive to meropenem with the~     current treatment regimen. Will the investigators findings motivate routine monitoring of~     plasma concentrations in children receiving meropenem? Up to 50 patients will be included in~     the study, and all participants are children.~   "
173872|NCT01289236|"~     The purpose of this study is to compare the safety and efficacy of multiple doses of~     Milnacipran to a placebo dose in subjects with Chronic Shoulder Pain.~   "
173873|NCT01289223|"~     To compare the efficacy of bendamustine against treatment of physician's choice on~     progression-free survival in subjects with indolent B-cell NHL.~   "
173874|NCT01289210|"~     This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug~     that stimulates the immune system) in combination with radiation therapy in treating patients~     with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9~     intratumoral injections of VTX-2337 over the course of 3 months.~   "
173875|NCT01289197|"~     The primary goal of this project is to examine the short and long-term effects of an~     intervention focusing on three interrelated dimensions of health: improving sleep, increasing~     physical activity, and improving skills in emotion regulation. This intervention targets~     high-risk youth at a key neuromaturational period—early adolescence—when many individuals are~     experiencing new challenges to regulatory systems involved in sleep, activity, and emotion~     regulation. This maturational period is also a crucial time in the normal development of~     habits, skills, and proclivities in each of these domains. Thus, early adolescence presents~     unique opportunities for intervention targeting these three interrelated regulatory systems.~     Participants will include 200 9-13 year-old children who are siblings of children enrolled in~     one of three ongoing studies of vulnerability and resilience, whose families were initially~     identified on the basis of sociodemographic, child, and/or family risk or are recruited thru~     local Family Centers. Children will be selected as having difficulties in at least one of~     these domains (sleep, sedentary behavior, or emotion regulation) and then randomly assigned~     to either a control or intervention group. All families will receive baseline, one- and~     two-year follow-up assessments of child sleep, physical activity, and emotion regulation.~     Families in the intervention group will have the opportunity to receive feedback and~     intervention services on these three child domains and other parenting and family issues~     (e.g., parent involvement, parent self-care, school problems) following the initial~     assessment and the one-year follow up. The intervention will involve the parent and target~     youth receiving feedback about the child's current status in these areas and family~     functioning. If desired, the family will also participate in follow-up meetings with the~     parent and/or target youth to improve the youth's sleep, physical activity, and/or emotion~     regulation skills, as well as aspects of the family environment. The investigators~     hypothesize that the intervention will be associated with improvements in sleep, physical~     activity, and emotion regulation among those in the intervention group, as well as~     improvements in measures of social, behavioral, and affective function. Finally, the~     investigators will explore the possibility that increases in parental involvement mediate~     some of the changes found in child sleep, physical activity, and emotion regulation.~   "
173876|NCT01289184|"~     To monitor air quality in selected photocopier units and to assess the health status of~     workers who are exposed to emissions from photocopiers.~   "
173877|NCT01289171|"~     Many human immunodeficiency virus (HIV)-positive children are afflicted with diffuse flat~     warts that have been recalcitrant to multiple treatments.The aim of this prospective study~     was to evaluate the efficacy, safety and tolerability of 15% glycolic acid lotion (NeoStrata)~     for treatment of flat warts in HIV-positive children in Botswana. Additionally, the~     investigators characterized the flat warts in this population, including Human Papillomavirus~     (HPV) type(s) and degree of immunosuppression within the patients.~   "
173878|NCT01289158|"~     The investigators are interested in learning more about the changes found in the condition~     called Combined elevation of Malonic and MethylMalonic Acid, or CMAMMA.  Malonic, or MA and~     MethylMalonic, or MMA, are acids formed from the breakdown of protein under normal~     conditions. However, in the condition called CMAMMA there is an increase of these acids in~     the blood and urine, which is not normal.~      Some people with high MA and MMA in their blood and urine have a serious disease, starting as~     a baby or young child that includes heart disease and problems in learning. These people have~     changes in a special enzyme called Malonyl CoA Decarboxylase (MCD). Other people who have a~     high level of MA and MMA do not have any obvious illness. The investigators are not sure why~     they have high levels of MA and MMA and why they are not sick.~      The goal of this study is to learn more about why some people have a high level of MA and MMA~     and to make sure there are no medical problems as a result of these high levels. The~     investigators also want to find out which gene and enzyme cause the high levels of MA and~     MMA.~   "
173879|NCT01289145|"~     The purpose of this study is to increase regular physical activity among students by~     fostering self-management competencies. The intervention was implemented as paper-pencil~     intervention. The aim of this research project is to evaluate a motivational and volitional~     intervention in comparison to a control intervention.~      Study participants will be recruited in lectures at Freie Universitaet Berlin and followed up~     twice (two and ten weeks after baseline).~      The motivational intervention is expected to increase unmotivated participants' intention to~     be physically active. The volitional intervention is expected to promote physical activity~     among motivated but inactive participants. Both interventions are hypothesized to improve~     self-management competencies over time.~   "
173880|NCT01289132|"~     The purpose of this study was to evaluate the dose-response relationships of azilsartan, once~     daily (QD) in participants with mild to moderate uncomplicated essential hypertension.~   "
173881|NCT01289119|"~     The purpose of the study is to determine the efficacy of alogliptin compared to placebo when~     given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without~     metformin).~   "
173882|NCT01289106|"~     The purposes of this study include 1) to compare the seroconversion rate of an intensive~     standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months),~     and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2~     and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in~     HIV-infected adult patients.~   "
173883|NCT01289093|"~     LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a~     good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a~     disease-specific quality of life questionnaire, designed by an American group, to monitor~     quality of life in patients undergoing operation for hernias.~      The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores~     for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality~     of life and other well-known core-symptoms before and after herniotomies.~   "
173884|NCT01289080|"~     This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1~     group of subjects with normal renal function and 1 group of severely renally impaired~     subjects.~   "
178414|NCT01229696|"~     Research study to determine the relationship between perineural catheter tip location~     relative to the sciatic nerve bifurcation and postoperative analgesia for continuous~     popliteal nerve blocks.~   "
173885|NCT01289067|"~     The purpose of the study is to test genes for BRCAness(BRCA[BReast CAncer] gene) Studying~     these genes could help predict which patients would benefit from treatment with satraplatin,~     a medication being used for subjects who have failed prior chemotherapy. All subjects will~     have a biopsy of metastatic lesions to measure BRCAness (a gene signature). This gene~     signature may be able to predict response to satraplatin and a tool will be developed to be~     able to screen patients likely to benefit from satraplatin. Subjects will all receive~     Satraplatin days 1-5 and Prednisone 5 mg twice daily every 35 days. Response rates will be~     evaluated every 2 cycles or approximately every 9 weeks. Patients will be considered~     responders if they have measurable disease meeting criteria for partial or complete response.~     PSA will be measured day one of each treatment cycle. Each treatment cycle is 35 days.~   "
173886|NCT01289054|"~     This is a voluntary, international, primarily prospective, observational, exposure-registry~     and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six~     months prior to pregnancy.~   "
173887|NCT01289041|"~     This is a prospective multi-center, open-label, single arm, Phase II study to investigate the~     safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease~     progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120~     orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a~     fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase~     (PI3K) pathway activation status.~   "
173888|NCT01289028|"~     This study will evaluate the preliminary efficacy of nilotinib in pretreated patients~     (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.~   "
173889|NCT01289015|"~     The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once~     daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with~     tinea pedis.~   "
173890|NCT01289002|"~     The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix~     Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.~   "
173891|NCT01288989|"~     A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5~     in subjects with advanced solid tumors that are refractory to standard therapy or for which~     no standard therapy is available.~   "
173892|NCT01288976|"~     The MitraClip System enables the European physicians an alternative therapeutic option for~     patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac~     surgery, and palliative medical therapy with or without device therapy. The study will~     observe the outcomes of patients treated with the MitraClip System throughout 12-months as~     compared to the outcomes of patients treated by alternative therapies.~   "
173893|NCT01288963|"~     The purpose of this study is to determine which participants with melanoma have a better~     response to IL-2 and to identify markers that may predict response to IL-2 by collecting~     participant information (for example; cancer diagnosis and history, prior treatments for~     cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after~     treatment.~   "
173894|NCT01288950|"~     The purpose of this study is to determine whether a single oral dose of vitamin D given to~     infants prior to Bacille-Calmette-Guerin (BCG) vaccination will enhance the immune response~     to BCG vaccination.~   "
173895|NCT01288937|"~     Milnacipran helps serotonin and noradrenaline work more effectively on the central nervous~     system. Serotonin and noradrenaline are molecules made by the brain that affect how your body~     responds to pain. Milnacipran, a dual norepinephrine and serotonin reuptake inhibitor has~     been a safe and beneficial treatment for patients with fibromyalgia and may be useful to~     treat patients with painful peripheral neuropathy. Many clinical trials for neuropathy pain~     are done in patients with diabetic neuropathy. Idiopathic neuropathy however, is a common~     cause of neuropathy and accounts for 25% of all neuropathies, and over 50% of small fiber~     neuropathies. The information in this study will provide information on whether milnacipran~     also provide benefit as a medication for neuropathic pain.~   "
173896|NCT01288924|"~     The purpose of this study is to compare the efficacy of parecoxib with placebo on the~     incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement~     for relieving severity of postthoracotomy shoulder pain and adverse events associated with~     treatment.~   "
173897|NCT01288911|"~     The purpose of this study is to determine the efficacy and safety of oral enzalutamide~     compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed~     while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a~     bilateral orchiectomy.~   "
173898|NCT01288898|"~     This study determined the safety of ASP1941 after a single and multiple once-daily doses for~     10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD)~     of ASP1941 were assessed.~   "
173899|NCT01288885|"~     This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics~     (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether~     the intake of food had an effect on the PK of ASP1941 (Part B).~   "
173900|NCT01288872|"~     The purpose of the study is to understand whether the drug praziquantel (PZQ) is metabolized~     or broken down differently when women are pregnant versus not pregnant. PZQ is used to treat~     schistosomiasis (worm infection). Researchers will study how PZQ is broken down among 15~     women who are 12-16 weeks pregnant, 15 women who are 30-36 weeks pregnant, and 15 women~     nonpregnant women who are producing breast milk. All women will be 18 or older and otherwise~     healthy. The usual practice is to wait until after mothers have finished pregnancy and breast~     feeding before giving PZQ. Participants will receive 2 doses of PZQ separated by 3 hours.~     Study procedures will include a 24 hour hospital stay following administration of PZQ, blood,~     stool and urine samples, ultrasound if pregnant, and physical exams of mother and baby.~     Patient participation for mother/infant pair is about 9 months.~   "
173901|NCT01288859|"~     Polyphenolic compounds exert several health benefits depending on bioavailability.~     Encapsulation may improve bioavailability of these compounds.This study will evaluate~     bioavailability of some polyphenols (curcumin and cocoa polyphenols) from new enriched-foods.~     In particular bread and nut based creams will be used as food matrices to include free or~     encapsulated polyphenols.~   "
178415|NCT01229683|"~     Research study to determine the proportion of cases in which an interscalene brachial plexus~     nerve block produces hand and forearm anesthesia.~   "
173902|NCT01288846|"~     30 patients acute hospitalized to medical ward and their medication records are examined. It~     is to be recorded how the investigators find information about medicine use by the reception~     when they do not follow the patient. The record of the changes made during hospital stay is~     examined, whether they are justified in the discharge summaries and whether they are~     described in the medical list. After a month is to find out if the GP has recorded or~     possibly rejected changes to medication made in hospital.~   "
173903|NCT01288833|"~     The investigators hypothesize that high definition colonoscopy with close focus narrow band~     imaging features has a high diagnostic accuracy for colorectal polyp histology, and can~     replace formal pathologic assessment in cases of high diagnostic confidence.~   "
173904|NCT01288820|"~     This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium~     vivax malaria during November 2010 to March 2012. The aim of the study is to compare the~     efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and~     dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The~     significance of the study is to find alternative drug for treating patients with vivax~     malaria in case the standard treatment is not available or become resistance. This study will~     give thorough information about the efficacy and safety of 2 artemisinin-based combination~     therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry~     of Health on their suggested policies for radical cure of vivax malaria, and provides~     evidence based treatment options for chloroquine resistant vivax malaria. This study will~     also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD)~     deficiency and G6PD variants in North Sumatera population.~   "
173905|NCT01288807|"~     The investigators want to study the effects of milnacipran treatment on neurotransmitter~     release in fibromyalgia.~   "
173906|NCT01288794|"~     Ascites is the most frequent complication of liver cirrhosis and carries a significant~     worsening of the prognosis. Approximately 10% of patients per year develop refractory ascites~     because of either the lack of response to medical treatment or the onset of diuretic-induced~     complications that preclude the use of an effective dosage. Refractory ascites is associated~     with an increased incidence of severe complications of cirrhosis. Thus, the overall~     probability of survival of patients with refractory ascites is very poor, being approximately~     30% at 2 years. Repeated large-volume paracentesis, transjugular intrahepatic portosystemic~     shunt (TIPS), and liver transplantation represent the therapeutic alternatives for refractory~     ascites. As renal sodium retention and ascites formation are the consequence of portal~     hypertension and effective hypovolemia, the preservation of the central blood volume~     represents a major purpose in the management of patients with advanced cirrhosis. Although~     albumin is responsible for about 70% of the plasma oncotic pressure, the absence of large~     multicenter randomized studies together with its high cost explains why albumin infusion is~     not usually included among the therapeutic options for difficult-to-treat ascites.~      The objective of the present study is to define the effectiveness of the prolonged~     administration of human albumin in the treatment of liver cirrhosis with ascitic~     decompensation. This goal will be reached by performing a multicenter, prospective,~     randomized clinical trial comparing the efficacy of chronic albumin administration on top of~     standard medical treatment versus standard medical treatment alone in patients with cirrhosis~     and ascites.~      The study will be conducted in 44 Italian clinical centers and will enrol 440 in- or~     out-patients affected by liver cirrhosis with uncomplicated ascites who will be randomized~     with a ratio of 1:1. The duration of the study for each patient is 18 months from~     randomization. The enrolment of patients will last 18 months and will be competitive between~     centers. Treatment will be interrupted if one of the following condition occur: orthotopic~     liver transplantation, TIPS, need of 3 paracentesis/month (indication to TIPS), patient~     refusal to continue, and medical judgement.~      An ancillary optional study will be performed in a subset of patients to analyze the~     non-oncotic properties of albumin.~   "
173907|NCT01288781|"~     The purpose of this study is to determine whether increased pressure in the head is elevated~     in people who suffer from High Altitude Headache. We hypothesise that head pressure will be~     elevated in people with High Altitude Headache.~   "
173908|NCT01288768|"~     The purpose of this study is to determine whether a knee arthroscopy is effective in the~     treatment of middleaged patients with meniscal symptoms also receiving a standardised~     exercise program.~   "
173909|NCT01288755|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     raltegravir (administered as 400 mg, twice daily) on the steady-state pharmacokinetics of~     TMC278 (25 mg, once daily), and vice versa. Steady state is a term that means that the drug~     has been given long enough so that the plasma levels will remain at about the same level with~     each subsequent dose. TMC278 is being investigated for the treatment of human~     immunodeficiency virus (HIV) infection. Raltegravir is a commercially available~     antiretroviral drug for treatment of HIV infection. Pharmacokinetics (PK) means how the drug~     is absorbed into the bloodstream, distributed in the body and eliminated from the body.~   "
173910|NCT01288742|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 on the single-dose pharmacokinetics of digoxin or rosuvastatin , and the effect of a~     single dose of digoxin or rosuvastatin on the steady-state pharmacokinetics of TMC435. Steady~     state is a term that means that the drug has been given long enough so that the plasma~     concentrations will remain the same with each subsequent dose. TMC435 is being investigated~     for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means~     how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from~     the body.~   "
173911|NCT01288729|"~     This is an open-label cross over study looking to compare the length of infusion set wear~     between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.~   "
173912|NCT01288716|"~     To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the~     treatment of social withdrawal in subjects with autism spectrum disorders~   "
173913|NCT01288703|"~     The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS~     computerized-adaptive testing in women with urinary incontinence.~   "
173914|NCT01288690|"~     This interventional, randomized controlled study tests the effects of a a brief psychological~     intervention (Narrative Exposure Therapy) against a wait list control group among refugees~     who have experienced trauma and have some symptoms of PTSD.~   "
173915|NCT01288677|"~     The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of~     single oral doses of TMC649128 in healthy volunteers. Pharmacokinetics (PK) means how the~     drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.~   "
173916|NCT01288664|"~     This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release~     Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).~   "
173917|NCT01288651|"~     Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency were~     previously shown to have a decreased six-minute walking distance. Therefore the investigators~     hypothesized that intravenous iron administration would improve exercise capacity in iron~     deficient IPAH patients.~      30 patients will be recruited for iron infusions. At baseline and after 12 weeks~     (endpoint)exercise test will be performed.~   "
173918|NCT01288638|"~     The purpose of our study is to evaluate the effectiveness of a lifestyle program for women~     with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the effect of a~     pulse-based diet (i.e. a diet that contains lentils, chick-peas, peas, and beans) and aerobic~     exercise for improving PCOS disease features and risk factors for metabolic syndrome. We~     would like to determine the therapeutic effects of a lifestyle program that combines a~     pulse-based diet and exercise on the multiple disease measures of PCOS and metabolic~     syndrome.~   "
173919|NCT01288625|"~     The purpose of this study is to compare the incidence of stomatitis when treating with~     amifostine before radiation treatment.~   "
173920|NCT01288612|"~     The hypothesis of this study was that the comparative effectiveness of unsedated transnasal~     endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for~     BE.~   "
173921|NCT01288599|"~     Keyhole surgery for adnexal disease has traditionally been performed using three or four~     small incisions. The last years a new operating method has been introduced. This method makes~     use of only one incision of 2 cm in the umbilicus. This method is less invasive, and it might~     benefit the patient through less postoperative pain and a higher satisfaction with the~     cosmetic result. So far, many studies have shown that this new method is feasible for adnexal~     disease, but its superiority compared to conventional laparoscopy is to be proven. This study~     aims to show this difference.~      The investigators aim to compare experienced postoperative pain and use of analgesics in~     patients undergoing single port laparoscopy for benign adnexal disease with conventional~     laparoscopy. The investigators hypothesize that the patients will experience less~     postoperative pain and use less analgesic in the single port laparoscopy group.~      Further, the investigators aim to compare the satisfaction with the cosmetic results in the~     two groups. In addition, blood loss, operating time, complications and conversion to~     conventional laparoscopy will be registered in the two groups.~   "
173922|NCT01288586|"~     The purpose of this study is to examine the long term survivorship of the Scandinavian Total~     Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal~     rate of any component of the STAR ankle.~   "
173923|NCT01288573|"~     This is a multi-site study with plerixafor in pediatric cancer patients. The study will be~     conducted in 2 stages:~        -  Stage 1 is a dose-escalation study.~        -  Stage 2 is an open-label, randomized, comparative study using the appropriate dosing~          regimen identified in the Stage 1 dose-escalation study.~      All participating patients will receive a standard mobilization regimen as per study site~     practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating~     factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization~     regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage~     1 (dose escalation), and for those patients randomized to the plerixafor plus standard~     mobilization treatment arm in Stage 2 (randomized, comparative).~      Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.~   "
173924|NCT01288560|"~     Medical imaging is one of the fastest growing sectors in health care and increases in~     utilization underscore the need to ensure imaging technology is developed and used~     effectively. Evaluation of the clinical and economic impact of such imaging lags behind the~     technology development. Heart failure (HF)represents the final common pathway for most forms~     of heart disease and morbidity and mortality remain high. There is a need to identify imaging~     approaches that have a positive impact on therapy decisions, patient outcomes and costs. As~     well as standard methods to evaluate new and emerging techniques to better test their~     potential in a clinical management setting. The OVERALL OBJECTIVES of the IMAGE-HF trial are~     1) to determine the impact of emerging imaging strategies, on relevant clinical outcomes and~     decision making in patients with HF; 2) to establish standardization quality assurance (QA)~     measures and central databases in order to achieve reliable outcome driven research; 3) to~     apply this as a platform for evaluation of new and emerging imaging biomarkers in HF.~      Project I-A: The PRIMARY OBJECTIVE OF AIMI-HF is to compare the effect of HF imaging~     strategies on the composite clinical endpoint of cardiac death, MI, resuscitated cardiac~     arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia). Patients with an ischemic heart~     disease (IHD) etiology will follow HF imaging strategy algorithms according to the~     question(s) asked by the physicians (is there ischemia and/or viability), in agreement with~     their local practices for standard and alternative imaging.~      Secondary objectives of AIMI-HF To compare the effect of HF imaging strategies on~        1. The incidence of revascularization procedures (PCI, CABG)~        2. LV remodeling: LV volumes, LVEF~        3. HF symptoms, NYHA class~        4. QOL (MLHFQ, the EQ5D)~        5. The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP)~        6. Health economics: Costs estimated through regression analysis and cost effectiveness~          assessed through decision modeling.~        7. The safety of imaging tests measured by cumulative radiation, adverse reactions to~          imaging contrast agents and stress testing agents will also be determined.~        8. The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g.~          PIIINP, OPN).~   "
173925|NCT01288547|"~     The purpose of this study was to measure potential mood, cognition and blood pressure effects~     of theobromine and caffeine in healthy women~   "
173926|NCT01288534|"~     The purpose of this study is to evaluate the safety and tolerability of using radiation~     therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation~     using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5~     radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical~     treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of~     radiation using a smaller number of treatments has been called hypofractionated radiation~     therapy.~      The Calypso is a new technique which uses beacons implanted into the prostate which using~     radio signals are able to localize and track the position of the prostate continuously during~     radiation therapy. The Calypso system has been approved by the United States Food and Drug~     Administration (FDA) for guidance of radiation therapy during the treatment of prostate~     cancer and is being utilized all across the United States. However, it has not been tested~     for hypofractionated radiation therapy.~   "
173933|NCT01288443|"~     Primary Objective:~        -  To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein~          cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in~          participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin~          therapy.~      Secondary Objectives:~        -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment~          in comparison with placebo~        -  To evaluate the safety and tolerability of alirocumab~        -  To evaluate the development of anti-alirocumab antibodies~        -  To evaluate the pharmacokinetics of alirocumab~   "
173934|NCT01288430|"~     This phase 1 clinical trial is intended to understand the safety and tolerability of a new~     anticancer drug in subjects with advanced solid tumors. The patients who qualify for the~     study will receive a once daily dose of the drug taken by mouth and will undergo several~     tests to measure the drug in the blood and to understand the safety, tolerability and any~     effect of the drug on the tumor. The antitumor effect of the drug is not known in human.~   "
173927|NCT01288521|"~     Solid organ transplant recipients would greatly benefit from pharmacogenetic evaluation since~     immunosuppressive drug regimens consist of multiple medications with narrow therapeutic~     ranges and toxic adverse event profiles. Tacrolimus is a potent immunosuppressive agent~     utilized for rejection prophylaxis. Intensive pharmacokinetic monitoring must be performed~     following organ transplantation to ensure therapeutic drug concentrations due to its highly~     variable pharmacokinetics profile and narrow therapeutic index. Tacrolimus is a substrate for~     CYP450 3A and for the membrane transporter p-glycoprotein (Pgp). Polymorphisms in the gene~     encoding for CYP3A5 have been extensively studied and have been found to influence the dosing~     of tacrolimus. The effect of ABCB1 gene polymorphisms (which encodes for Pgp) upon tacrolimus~     pharmacokinetics has been more difficult to establish.~      This study will determine if haplotypes derived from three frequent polymorphisms in the~     ABCB1 gene (C1236T, G2677T, C3435T) can predict the degree of drug interaction between~     tacrolimus (CYP3A5/Pgp substrate) and ketoconazole (CYP3A5/Pgp inhibitor) in patients who are~     CYP3A5 nonexpressors.~      This prospective pharmacokinetic and pharmacogenomic study will enroll 20 stable renal~     transplant recipients with the CYP3A5 *3/*3 genotype and grouped by ABCB1 haplotype (CGC vs~     TTT). Pharmacokinetics of tacrolimus will be assessed on 2 occasions with and without~     ketoconazole coadministration separated by 1 week. The order of study occasions will be~     randomized in a crossover design.~      The results of this study may identify a genomic marker for predicting drug-drug~     interactions. Knowing this information a priori will aid clinicians in modifying drug dosing~     and alleviate patients of the burden of significant drug toxicities.~   "
173928|NCT01288508|"~     Background: Whether Supra-Fiber, a plum-derived fiber supplement is useful in the treatment~     of constipation is not known. Supra Fiber is the first fiber supplement that has a blend of~     whole food fruit as its main ingredient. It contains prunes, pomegranates, blueberries, and~     Acai berries. Unlike psyllium, which is mostly (90%) insoluble fiber, Supra Fiber is a~     balanced (50%) blend of insoluble and soluble fiber. This may provide the beneficial effects~     of fiber, and eliminate potential adverse symptoms of fiber such as bloating, distention,~     hard bulky stools and excess gas. In this study, we expect to not only evaluate the efficacy~     but also the palatability and tolerability of Supra Fiber in the treatment of chronic~     constipation.~      Aims:~        1. To investigate and compare the effects of Supra Fiber (5 grams BID) or psyllium (5 grams~          BID) on the number of complete spontaneous bowel movements per week, and bowel symptoms.~        2. To examine the effects of fiber supplements on taste and quality of life in adults with~          functional chronic constipation in a randomized, double-blind, parallel group controlled~          trial.~      Methods: We propose to enroll 90 subjects with functional constipation in a single blinded,~     randomized, cross-over study comparing 4 weeks of Supra Fiber with 4 weeks of treatment with~     Psyllium~      Data analysis: The primary outcome measure will be the global relief of constipation symptoms~     as rated by the subject at the end of each phase of the study. Additionally, we will assess~     several secondary outcome measures that will include the number of Complete Spontaneous Bowel~     Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste~     on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient~     rating of constipation-related symptoms.~      Expected results: We anticipate that treatment with Supra Fiber will improve symptoms of~     constipation compared to the baseline. This improvement will be comparable or superior to~     that achieved with psyllium treatment. Additionally, Supra Fiber will offer a natural, food~     based, convenient and more tasty alternative to over-the-counter laxatives and fiber~     supplements.~   "
173929|NCT01288495|"~     Data suggest that alanine may facilitate the intestinal absorption of fructose in patients~     with DFI and thereby may decrease GI symptoms.~      We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks~     that contain foods with free fructose or high fructose content will decrease GI symptoms in~     subjects with dietary fructose intolerance by facilitating intestinal absorption of fructose.~      Aim: To investigate the effects of co- administration of equi-molar doses of L-alanine or~     placebo on the occurrence of GI symptoms in subjects with dietary fructose intolerance, in a~     randomized, double blind, cross over study.~      Methods: We propose to investigate the effects of co-administration of equi-molar doses of~     L-alanine or placebo on the occurrence of GI symptoms in 70 subjects with dietary fructose~     intolerance, in a randomized, double blind, cross over study.~      Data Analysis: The primary outcome measure will be a comparison of baseline breath sample~     values and study visit breath sample values. Additionally, we will assess subject-reported~     occurence and severity of nine gastrointestinal symptoms during the test on a visual analog~     scale (VAS).~      Expected Results: We anticipate that dietary fructose intolerance (DFI) symptoms will improve~     with ingestion of supplemental L-alanine (along with foods containing free fructose or high~     fructose content). We additionally expect treatment of DFI with administration of L-alanine~     powder to be more practical than co-ingestion of alanine-rich foods, and more convenient for~     patients.~   "
173930|NCT01288482|"~     Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to~     operate continuously with tidal breathing. As inhalation accounts for only about one-third of~     the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the~     environment possibly posing a hazard any fellow-patients, family members, or health-care~     workers in the vicinity. The English-Wright has been the only American Thoracic Society~     (ATS)recommended device available on the market. Recently Roxon Medi-Tech has announced the~     discontinuation of the English-Wright nebulizer. For these reasons it is necessary to review~     the use of other nebulizers such as the AeroEclipse II breath-actuated nebulizer and further~     validate their performance.~      The investigators expect to show equivalence between the AeroEclipse II and the~     English-Wright nebulizers.~   "
173931|NCT01288469|"~     Primary Objective:~      To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein~     cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of~     atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L)~     on atorvastatin 10 mg.~      Secondary Objectives:~        -  To evaluate the effects of alirocumab on other lipid levels in comparison with placebo,~          when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.~        -  To evaluate the efficacy of alirocumab when co-administered with a high dose of~          atorvastatin (80 mg) versus atorvastatin 10 mg.~        -  To evaluate the safety and tolerability of alirocumab when co-administered with 2~          different doses of atorvastatin.~        -  To evaluate the development of anti-alirocumab antibodies.~        -  To evaluate the pharmacokinetics of alirocumab.~   "
173932|NCT01288456|"~     This will be an observational, prospective, non-randomized, pilot study to gain initial~     device experience on a novel space-occupying device in persons who are overweight or obese.~     No formal hypothesis testing will be conducted.~   "
173935|NCT01288417|"~     The objective of this study is to evaluate the effect of boceprevir (steady state) on the~     pharmacokinetics of a single dose of raltegravir. The effect on the boceprevir~     pharmacokinetics of a single dose raltegravir will also be evaluated (compared to historical~     controls). Furthermore, the safety profile of the combination is studied.~   "
173938|NCT01288378|"~     RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients~     with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their~     cancer. It is not yet known whether caspofungin acetate is more effective when treatment~     starts after development of a fever or after the infection is shown in laboratory test, chest~     x-ray, or CT scan.~      PURPOSE: This randomized phase III trial is studying the best time to start caspofungin~     acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome~     that is newly diagnosed or in first relapse.~   "
173939|NCT01288365|"~     The purpose of this study is to determine whether exercise training will improve functional~     capacity in patients with heart failure and preserved ejection fraction.~   "
173940|NCT01288352|"~     EAST prospectively tests the hypothesis that an early, structured rhythm control therapy~     based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF)~     related complications in patients with AF when compared to usual care.~      Patients will be randomized to early therapy or usual care. In the early therapy group,~     patients will receive either catheter ablation (usually by pulmonary vein isolation), or~     adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be~     selected by the local investigator. Upon AF recurrence, both modalities will be combined.~      Usual care will be conducted following the 2010European Society of Cardiology ( ESC~     )guidelines for AF treatment. Early rhythm control therapy will be guided by~     Electrocardiogram (ECG) monitoring.~   "
173941|NCT01288339|"~     To estimate the progression free survival for subjects treated with panitumumab in~     combination with a chemotherapy regimen of oxaliplatin, 5-Fluorouracil (5-FU) and leucovorin~     (FOLFOX) as first-line chemotherapy regimen for subjects with metastatic colorectal cancer~     with WT (wild type) KRAS according to the IGFRp (protein receptor insulin growth factor) and~     MMP-7 (Matrilysin) expression.~   "
173942|NCT01288326|"~     The study is conducted in Europe. The aim of this observational study is to assess glycaemic~     control while using liraglutide under normal clinical practice conditions in Belgium.~   "
173943|NCT01288313|"~     We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic~     acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating~     women~   "
173944|NCT01288300|"~     Main objective: To improve diabetes outcomes among Mexican-Americans with diabetes through~     church-based, culturally tailored, diabetes self-management interventions linked to the local~     healthcare system.~      Specific Aim: To pilot test a church-based, culturally tailored diabetes self-management~     intervention to improve diabetes outcomes among low-income Mexican-American with diabetes~      H1 A church-based diabetes self-care management curriculum partnered with the local~     healthcare system will improve glycosylated hemoglobin.~      H2 A church-based diabetes self-care management curriculum partnered with the local~     healthcare system will improve systolic blood pressure and low-density lipids.~      H3 A church-based diabetes self-care management curriculum partnered with the local~     healthcare system will improve diabetes related self-efficacy, self-empowerment and self-care~     management.~   "
173945|NCT01288287|"~     To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®)~     therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term~     clinical response at 18 months compared with a lack of clinical response at 12 weeks.~   "
173946|NCT01288274|"~     The purpose of this study was to demonstrate that with appropriate training, the provision of~     injectable contraceptives by community based reproductive health agents (CBRHAs) does not~     significantly differ from low-level clinic-based providers, or health extension workers~     (HEWs).~   "
173947|NCT01288261|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bavituximab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving paclitaxel together with bavituximab~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab~     together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative~     metastatic breast cancer~   "
173948|NCT01288248|"~     The purpose of this study is to determine whether the use of laryngeal mask classic as method~     for securing the airway in the population of 2 years to 14 years is associated with risk of~     laryngospasm as compared with the use of endotracheal tube.~   "
173949|NCT01288235|"~     Some patients with brain tumors receive standard radiation to help prevent tumor growth.~     Although standard radiation kills tumor cells, it can also damage normal tissue in the~     process and lead to more side effects. This research study is looking at a different form of~     radiation called proton radiotherapy which helps spare normal tissues while delivering~     radiation to the tumor or tumor bed. Proton techniques irradiate 2-3 times less normal tissue~     then standard radiation. This therapy has been used in treatment of other cancers and~     information from those other research studies suggests that this therapy may help better~     target brain tumors then standard radiation.~   "
173950|NCT01288222|"~     Donors with favorable KIR B haplotype gene content have yielded reduced relapse risk and~     improved leukemia free survival (LFS) in retrospective analyses of unrelated donor (URD)~     hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML). Specifically,~     donors with more KIR B gene content and those who are homozygous for the centromeric (Cen) B~     haplotype genes (as opposed to the telomeric (Tel) genes confer the most protective effect.~     This study proposes to prospectively test and validate the utility and effectiveness of~     further informing URD identification and selection by KIR genotyping as a supplement to HLA~     matching and the other variables known or suspected to indicate the best URD for a patient.~      Hypotheses:~        1. Favorable KIR donors will improve protection against relapse and improve leukemia free~          survival (LFS) after URD HCT for AML.~        2. Directed study procedures for rapid KIR genotyping and reporting to searching Transplant~          Centers (TC) can inform donor search and selection without delay in donor availability~          for HCT.~   "
173951|NCT01288209|"~     The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination~     with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus~     (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy~     in Japan.~   "
173954|NCT01288170|"~     Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis~     Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the~     respiratory affection which appears early in neonates.~      The constant improvement in symptomatic treatments and care strategies allowed CF patients'~     life expectancy to be increased over the last decades.~      Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years~     old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.~      Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is~     obtained by inhaled administration of tobramycin and is active against in vitro resistant~     Pseudomonas aeruginosa.~      Study hypotheses :~      Regarding literature data and in vitro studies, the administration of Nebcinal® 150mg/3ml~     administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of~     antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus®~     in children and adult patients with CF.~      Primary objective :~      To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by~     Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®~   "
173955|NCT01288157|"~     The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male~     participants.~   "
173956|NCT01288144|"~     The investigators hypothesize that computer-assisted decision support will increase the~     percentage of women with a history of gestational diabetes who receive appropriate follow-up~     screening.~      Specific Aim 1: Develop an algorithm to identify cases of gestational diabetes among patients~     in the Partners Health Care system using administrative and laboratory data.~      Specific Aim 2: Assess primary care provider knowledge, attitudes, beliefs, and barriers to~     compliance regarding screening guidelines for women with a history of gestational diabetes.~      Specific Aim 3: Test whether a computer-assisted decision support tool to identify patients~     with a GDM history and prompt screening will increase compliance with guidelines. The~     investigators hypothesize that decision support will significantly increase in the percentage~     of women screened.~   "
173957|NCT01288131|"~     Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve~     morbidity and mortality in chronic kidney disease. Subcutaneous use of r-HuEpo causes~     immunogenicity and develops anti-r-HuEpo associated pure red cell aplasia (PRCA). The~     treatment of anti-r-HuEpo associated pure red cell aplasia is controversial. The~     investigators aim to evaluate the treatment for anti-r-HuEpo associated pure red cell aplasia~     in this study.~   "
173958|NCT01288105|"~     The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management~     of patients with prior DES implantation who need major non-cardiac surgery and~     discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery~     until 30 days post surgery) incidence of major adverse cardiac events.~   "
173959|NCT01288092|"~     This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage~     design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in~     patients with progressive metastatic HR+ HER2- breast cancer who have received at least one~     prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic~     disease. Patients will be stratified into 3 groups according to their PI3K~     (phosphatidylinositol 3-Kinase) pathway activation status.~   "
173960|NCT01288079|"~     The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy~     in patients with major depressive disorder who exhibit inadequate response to~     antidepressants.~   "
173961|NCT01288066|"~     The clinical question on whether or not to replace the glenoid component in patients with a~     degenerative shoulder disease, has not been answered yet in a randomized study with enough~     statistical power. In this study, patients are randomly allocated to a treatment with a hemi-~     or total shoulder arthroplasty using implants of the Epoca system. The primary objective is~     the comparison of pain and function between the treatment groups after 5 years using the~     Constant score.~   "
173962|NCT01288053|"~     Allogeneic transplantation has been a high-risk procedure, although non-myeloablative~     conditioning regimens (mini-transplantation) minimizes regimen related toxicity. The~     investigators, therefore, propose a phase I study of matched sibling allogeneic hematopoietic~     stem cell transplantation with non-myeloablative conditioning. In addition, graft versus host~     disease (GVHD) will be virtually eliminated by CAMPATH that removes donor T cells from the~     graft.~      The goal is to assess the toxicity/efficacy (phase I) of allogeneic non-myeloablative~     hematopoietic stem cell transplantation for high-risk Crohn's disease. In simplistic terms,~     this protocol is designed to ablate an aberrant immune system and then, similar to the use of~     marrow transplants for immunodeficient patients, reconstitute a new immune system with~     lymphocyte depleted marrow.~   "
173963|NCT01288040|"~     The purpose of this study is to determine whether split belt training can be used to treat~     walking pattern deficits from stroke and to determine whether different schedules and types~     of long term training on a custom split belt treadmill are likely to change/improve walking~     symmetry.~   "
173964|NCT01288027|"~     This is an open-label, multicenter study of participants with late-onset Pompe disease naive~     to treatment with enzyme replacement therapy (ERT). The primary objective of this study is to~     evaluate glycogen clearance in muscle tissue samples collected pre and post alglucosidase~     alfa treatment in participants with Late-Onset Pompe disease.~      The secondary objectives are to characterize the disease burden in participants with~     late-onset Pompe disease and explore imaging, histologic, and functional assessments in these~     participants and to explore potential plasma or urine biomarkers relative to late-onset Pompe~     disease and participant's response to treatment with alglucosidase alfa~     (Myozyme®/Lumizyme®/GZ419829).~   "
173977|NCT01287858|"~     AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2~     hours after dosing) with approximately 240 mL of water either once daily or twice daily. It~     is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple~     oral doses of AC430.~   "
173978|NCT01287845|"~     PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of~     BAY1075553 in patients with prostate cancer and in healthy volunteers~   "
174055|NCT01286818|"~     The primary objective of this study is to investigate the safety and tolerability of the~     anti-vascular endothelial growth factor receptor-2 (anti-VEGFR-2) monoclonal antibody~     Ramucirumab (IMC-1121B) in combination with irinotecan, levofolinate, and 5-fluorouracil~     (FOLFIRI) in Japanese participants with advanced colorectal carcinoma (CRC).~   "
173965|NCT01288014|"~     After immunization, particularly in older persons, some people are protected from disease by~     a vaccine and others are not. The investigators believe that this variable response may be~     due to overproduction of molecules that suppress development of immunity (antibodies and cell~     mediated immunity). Normally, these molecules are produced to make sure that immunity is~     regulated in just the right way for the body as a whole, and to prevent autoimmune disease.~      However, with aging, the immune system may have difficulty in proper immune regulation. Over~     production of immunosuppressive molecules after vaccination may interfere with the effects of~     a vaccine. For example when elderly individuals are immunized against zoster with a licensed~     vaccine, Zostavax, the vaccine is effective in only about 50 to 60%. The investigators will~     compare blood levels of antibodies, cellular immunity, and immunosuppressive molecules in~     recipients of Zostavax to see if there is a correlation between development low immunity and~     high levels of immunosuppressive molecules.~   "
173966|NCT01288001|"~     A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of~     one intra articular injection of sodium hyaluronate 2.0% in patients with painful~     osteoarthritis of the knee~   "
173967|NCT01287988|"~     The primary objective of this study is to assess visual function in up to 44 patients who~     have previously participated in either of the placebo controlled, ocriplasmin Phase III~     studies (TG-MV-006 or TG-MV-007).~   "
173968|NCT01287975|"~     This study is carried out to find out if Brain Computer Interface (BCI) technology or BCI~     technology coupled with robotic technology using a Haptic Knob will benefit patients with arm~     paralysis after stroke. BCI uses EEG-based motor imagery to detect user's thinking abilities~     which control motor movement. Haptic Knob is a novel robotic device, which specifically~     trains the wrist and hand with intensive repetitions in a supported environment.~   "
173969|NCT01287962|"~     Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase~     inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II~     clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated~     toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present~     phase III trial, the investigators will further evaluate the efficacy and toxicities of~     apatinib in the treatment of advanced non-squamous non-small cell lung cancer.~   "
173970|NCT01287949|"~     Primary objective:~        -  To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0,~          1 and 6-month schedule induce an acceptable immune response in terms of seroprotection~          rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40~          years of age or older with no diphtheria- and tetanus-containing booster within the last~          20 years~        -  To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of~          the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these~          subjects~      Secondary objectives:~        -  If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine~          containing Td-IPV valences induce an acceptable response in terms of seroprotection~          rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40~          years of age or older with no diphtheria- and tetanus-containing booster within the last~          20 years~        -  To describe the immune responses to REPEVAX in these subjects~        -  To describe the immune responses to REVAXIS administered 1 and 6 months after the~          administration of REPEVAX in these subjects~   "
173971|NCT01287936|"~     The primary purpose of the clinical study is to determine the safety of a modified stem cell~     SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to~     determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke~     patients must be between 6 and 60 months after their stroke, and with only this one prior~     stroke, and and with no further improvement from physical therapy.~   "
173972|NCT01287923|"~     Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent high grade lymphoma in adults.~     Although immunotherapy has improved its prognosis, DLBCL is a heterogeneous disease with~     patients exhibiting a wide range of outcomes with a 5-year overall survival ranging between~     55 to 94% depending of the International Prognostic Index factor. Diagnostic and prognostic~     biomarkers are mandatory to optimize treatment. Transcriptomics has been used to detect such~     new biomarkers using microarrays analyses applied to RNA collected from total tumor tissues~     or cell extracts. Molecular prognostic factors have been thoroughly studied in DLBCL tumor~     tissues. However, it is a big challenge to obtain transcriptomic-qualified tumor samples in a~     multicentric and prospective clinical trial. Coordinating nvestigator hypothesized that blood~     may be a deep source of native and secreted analytes and therefore carries transcriptomic~     signatures related to DLBCL and its prognosis. This project is organized in the extension of~     the GOELAMS-075 clinical trial which concerns aggressive DLBCL.~   "
173973|NCT01287910|"~     The primary goal of this study is to better understand how Transmyocardial Laser~     Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in~     individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed~     Tomography (CT) images in some patients.~   "
173974|NCT01287897|"~     This is a proof of concept study to determine the efficacy and safety of a monoclonal~     antibody with three doses versus placebo. Subjects will be randomized to a treatment and the~     dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate~     to severe refractory Crohn's Disease.~   "
173975|NCT01287884|"~     The primary objective of this study is to identify a correlation between the pH and pCO2 in~     arterial and venous blood. The secondary objectives include a correlation of pulse oximetry~     and arterial pO2 along with subgroup analyses of specific patient populations such as~     congestive heart failure, chronic obstructive pulmonary disease, diabetic ketoacidosis,~     pneumonia, overdose, and trauma.~   "
173976|NCT01287871|"~     This study aims to 1) implement a culturally and contextually rooted innovative multifoci,~     social marketing intervention involving societal focused media campaign elements to break~     down the barriers and facilitate timely and appropriate screening practices for cervical~     cancer; 2) measure cervical cancer stigma from a culturally relevant theoretical and~     conceptual framework; and 3) assess the influence of stigma on hindering seeking the PAP~     test. Further, this is an international study that will bring together a multi-disciplinary~     investigatory team, community advocates and State health agencies to deliver a social~     marketing intervention in Southern California (the Inland Empire region specifically) and~     Trinidad and Tobago.~   "
173979|NCT01287832|"~     There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia~     (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA~     bacteremia over the last 40 years. This has been largely attributed to isolates with~     increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was~     approved several years ago for the treatment of SAB and is being increasingly used for MRSA~     bacteremia due to isolates with increased MIC. Increased doses have been recommended for both~     of these drugs in the treatment of this infection without a trial demonstrating their~     relative efficacy or safety at higher doses. This study will randomize patients with SAB due~     to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and~     daptomycin used at higher than traditional doses.~   "
173980|NCT01287819|"~     1. Apolipoprotein E gene (ApoE) is the most important genetic factor for Alzheimer disease~          (AD) and an important genetic factor for outcome of brain injury situations.~        2. Function magnetic resonance imaging (fMRI) is a powerful tool for study of both brain~          regional functions and brain network.~        3. Study about genetic contribution on fMRI is an emerging concept, which will help on~          understanding about how the genetics affecting the brain function.~   "
173981|NCT01287806|"~     The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation~     lung injury patients.~   "
173982|NCT01287793|"~     Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in~     QT/QTc intervals.~   "
173983|NCT01287780|"~     The majority of elderly patients with a displaced fracture of the proximal femur are now~     treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication,~     and the infection rate is high in this group of elderly patients. Local application of~     gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to~     determine whether locally administered collagen-gentamicin in the joint perioperatively in~     addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early~     postoperative infection rate (< 4 weeks postoperative)after hemiarthroplasty in proximal~     femoral fractures.~   "
173984|NCT01287767|"~     Dementia is one of the most common and devastating diseases in the elderly, it leads to~     helplessness, no cure exists and therefore care is necessary to provide. The care is~     associated with a great burden for the family carers and expensive for the society when~     residential care is required. The purpose of this study is to improve knowledge on how to~     provide better care for both the patients and their family carers, the investigators want to~     carry out a controlled trial using a rather cheap form of intervention, a multidimensional~     support program - an 18 months randomized controlled intervention study.~   "
173985|NCT01287754|"~     This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib)~     in patients with locally advanced or metastatic non-small cell lung cancer with epidermal~     growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg~     daily orally until disease progression or unacceptable toxicity occurs.~   "
173986|NCT01287741|"~     This open-label, randomized, parallel group study will evaluate the efficacy and safety of~     obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone~     or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously~     untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large~     B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000~     milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter~     (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV~     every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two~     doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.~   "
173987|NCT01287728|"~     Abnormal vaginal flora is currently diagnosed among women (20-40%). It is associated with~     symptoms (bad smell, vaginal discharge) and adverse out-comes in pregnant and not pregnant~     women. The high recurrence rate raises the long-term effectiveness of therapy. The hypothesis~     is the persistence of bacteria associated with vaginal flora imbalance as Atopobium vaginae~     and Gardnerella vaginalis. At the present time there is a lack of an accurate marker for the~     risk of recurrence.~   "
173988|NCT01287715|"~     The purpose of this study is to determine whether etanercept can be withdrawn successfully~     (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom~     disease remission is reached.~      Goals:~        1. to investigate in a randomized controlled trial:~             -  which proportion of JIA patients in remission can successfully discontinue~               etanercept compared to JIA patients in remission who continue etanercept;~             -  if time in remission on etanercept is an important factor in retaining remission~               after discontinuation of etanercept.~        2. to investigate in alle JIA patients who discontinue etanercept (including the control~          group):~             -  predicting factors (patient or disease characteristics, including time in~               remission, and MRP8/MRP14) for successfully discontinuation of etanercept;~             -  the disease course after discontinuation of etanercept (time to flare) and the~               effect of restarting etanercept after flaring.~   "
173989|NCT01287702|"~     The impact of feeding after endoscopic treatment of gastroesophageal varices has never been~     investigated. It is still unknown whether early feeding may increase early rebleeding in~     patients with acute esophageal variceal bleeding treated with EVL. It is customary for~     clinicians to institute fasting for 2 or 3 days after emergency EVL. This may be a safe~     approach to watch against early rebleeding. However, many patients would be fasting for a~     longer time and nutrition may be impaired, possibly resulting in aggravation of ascites.~     Thus, the investigators conduct a controlled study to evaluate whether early feeding have a~     bad impact on patients receiving emergency EVL or histoacryl injection for bleeding gastric~     varices.~   "
173990|NCT01287689|"~     This non-interventional, epidemiological study assesses long-term outcomes in subjects~     receiving immunoglobulins (IgG) for any treatment purpose, irrespective of the regimen~     prescribed by the treating physician, under routine clinical conditions in Germany.~      Long-term outcome data are collected on patient characteristics in the various indications,~     drug utilization of intravenous and subcutaneous IgG (e.g. treatment and dosing patterns),~     effectiveness (i.e. number of infections), tolerability, health related quality of life, and~     economic variables (number of hospitalizations, sick-leave days etc.) with the possibility to~     estimate direct costs.~   "
173991|NCT01287663|"~     Homelessness, also name the fourth world, is a growing public health problem worldwide.~     Previous studies showed that up to 30% of the homeless people reported pruritus that often~     results in itchy lesions, which expose them to bacterial skin infections.~      The investigators therefore conducted a randomized, double-blind, placebo-controlled trial to~     test the hypothesis that a single oral dose of ivermectin was effective in significantly~     reducing the prevalence of pruritus in a sheltered homeless population.~   "
173992|NCT01287637|"~     The study is being conducted as a prospective randomized controlled multicenter study of~     patients with a temporary ileostomy due to rectal cancer. The study will be conducted in~     hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes~     Group (www.ssorg.net).~      The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead~     of later reversal more than 12 weeks after surgery.~   "
173993|NCT01287624|"~     This is a prospective, multi-center, open-labeled, randomized phase III clinical trial~     comparing overall response rate (ORR), progression free survival (PFS), overall survival (OS)~     and toxicity obtained with gemcitabine cisplatin combination (GP) versus gemcitabine~     paclitaxel combination (GT).~   "
173994|NCT01287611|"~     Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology~     Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S~     (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in~     subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies,~     ...) are very important issues. Classically Kerr incision is repaired with continuous locked~     suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in~     turn may reduce short and long term complications. For this reason, the investigators aimed~     to compare two closure techniques.~   "
173995|NCT01287598|"~     -  To evaluate the effect of BAY73-4506 on the pharmacokinetics of probe substrates of CYP~          2C9 (warfarin), 2C19 (omeprazole) and 3A4 (midazolam) administered in a cocktail~          approach and on the pharmacokinetics of a probe substrate of CYP 2C8 (rosiglitazone)~        -  To evaluate safety, anti-tumor activity, pharmacokinetics, and pharmacodynamics of~          BAY73-4506 in patients with advanced solid tumors~   "
173996|NCT01287585|"~     This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme~     versus placebo in patients with hepatocellular carcinoma who have failed prior systemic~     treatment (chemotherapy). Hepatocellular carcinomas have been found to require arginine, an~     amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the~     hepatocellular carcinoma cells will starve and die.~   "
173997|NCT01287572|"~     Pediatric patients admitted to the intensive care unit and requiring conscious sedation for~     minor surgical procedures are at risk to hypoventilate and retain CO2.~      The rise in CO2 levels is not well described and unpredicted. In this study the investigators~     will monitor CO2 levels transcutaneously using SDMS (SenTec digital Monitoring System) a~     device recently approved for clinical use. The hypothesis is ventilation of patients~     undergoing conscious sedation is compromised and CO2 levels might rise significantly to~     levels that potentially can effect hemodynamics.~      In order to avoid hemodynamic changes proper and routine monitoring is recommended.~   "
173998|NCT01287559|"~     The investigators are studying a disease called necrotizing enterocolitis (or NEC for~     short), which affects premature infants. It is the most common surgical emergency involving~     neonates admitted to Newborn Intensive Care Units. Currently, clinicians are unable to~     identify which infants will go on to develop NEC before they become ill. Clinical signs of~     illness occur relatively late in the course of the condition, making NEC more difficult to~     treat. The investigators will test a new probe that uses safe levels of visible and infrared~     light, with and without ultrasound imaging, to see if the investigators can identify infants~     before they get sick using a simple, noninvasive test, This test will be repeated through at~     least one feeding (which stresses the gut) each day. If successful, the health benefit will~     be large, as it is estimated that treating NEC alone (not including treating its later~     complications) adds $650 million to the annual health bill.~   "
173999|NCT01287546|"~     The objective of this study is to determine a recommended Phase 2 dose range of LY2875358~     that may be safely administered to participants with advanced cancer. In Part A and Part A2~     of this study, escalating doses of LY2875358 as monotherapy and in combination with erlotinib~     will be evaluated for safety and tolerability, respectively. Part B is a dose-confirmation~     segment for LY2875358 therapy in 5 different types of cancer: nonsquamous non-small cell lung~     cancer (NSCLC), castrate resistant prostate cancer (CRPC) with bone metastases, renal cell~     carcinoma (RCC), hepatocellular carcinoma (HCC), or uveal melanoma with liver metastases, and~     for LY2875358 in combination with trametinib in participants with uveal melanoma with liver~     metastases.~   "
174000|NCT01287533|"~     This study was to investigate the efficacy of oral monthly ibandronate in the management of~     glucocorticoid induced osteoporosis in women with rheumatoid arthritis.~   "
174001|NCT01287520|"~     The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of~     LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic~     cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B~     will consist of an expanded cohort to confirm the dose provided from Part A.~   "
174002|NCT01287507|"~     The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin~     (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis~     and the effect of LF on regulatory T cells.~   "
174010|NCT01287403|"~     Cereal grains contain a wide variety of different phytochemicals which may play different~     roles in physiology. Their response in plasma and urine after a meal is poorly defined for~     most cereals. This study will investigate the plasma response and urinary excretion of cereal~     compounds after eating 6 different types of cereal preparation, with a focus on~     alkylresorcinols.~   "
174011|NCT01287390|"~     Severe acute and late dysphagia is now considered as a dose-limiting toxicity of~     radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of~     life. We propose to preserve swallowing function by:~        -  adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to~          per-treatment changes occurring in the tumor and surrounding organs and tissues;~        -  reducing the volumes of elective neck, that may result in significant decrease of severe~          acute and late dysphagia.~   "
174003|NCT01287494|"~     Using a randomized controlled design, the investigators will examine whether the DCM is an~     effective treatment for patients with late life depression in urban China. Our specific aims~     are: (1) to determine whether the DCM intervention results in improved outcomes compared with~     CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels~     (e.g., greater reduction in depressive symptoms); and (2) to compare DCM with CAU with regard~     to a range of outcomes in other pertinent domains, both at the provider (e.g., improvements~     in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels. The study will~     take place in 16 primary care clinics (PCCs) randomly assigned to deliver either DCM or CAU~     (8 clinics each) to 320 patients (aged≥60 years) with major depression (20/clinic; n=160 in~     each treatment condition). In the DCM arm, PCPs will prescribe 16 weeks of antidepressant~     medication according to the TG protocol. CMs monitor the progress of treatment and side~     effects, educate patients/family, and facilitate communication between providers;~     psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients~     in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4,~     8, 12, 18, and 24 months. HDRS, MMSE, CAS, SF-12, Treatment Stigma and the Client~     Satisfaction Questionnaire will be used to assess patients' outcomes; and clinic practices,~     attitudes/knowledge, and satisfaction will be providers' outcomes.~   "
174004|NCT01287481|"~     This interventional, randomized controlled study seeks to test the effects of an innovative~     emotional exposure and processing treatment that targets stress resolution, by comparing it~     with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The~     investigators also will test proposed mediators of the intervention, including improved~     autonomic regulation, and explore which subgroups of patients benefit the most from each~     approach.~   "
174005|NCT01287468|"~     Over the past five years, a spectrum of studies has shown that the stromal cell populations~     surrounding or embedding cancer cells in a variety of different tumor types are intrinsically~     involved in the mechanisms affecting tumor growth and metastasis. Among these cells,~     fibroblasts and myeloid derived suppressor cells (MDSCs) have been shown to play key roles in~     the regulation of tumor cell behaviors, via differential gene expression, regulation and~     secretion of specific chemokines (e.g., RANTES, CXCL12 and CXCL14), cytokines (e.g., TNF-α,~     IL-1β, NF-κB) and control by inflammatory and immunomodulatory cells, molecules or potent~     growth factors. Of particular interest is that the various stromal immune cells (dendritic~     cells and T cells) and inflammatory MDSCs found in primary and metastatic tumors behave very~     differently from those present in normal or non-cancerous counterpart tissues. In light of~     these new understandings in cancer biology, the investigators believe that systematic and~     innovative approaches to further research are very much needed in Taiwan and at our Academy.~     Here the investigators propose to investigate the tumor suppressive effect of~     anti-inflammatory phytomedicines on regulation of stromal immune cells and fibroblasts in~     breast cancers. The investigators will employ the TS/A and 4T1 mouse mammary carcinoma system~     to conduct an in vivo study of several specific candidate phytomedicines (cytopiloyne,~     Wedelia chinensis, shikonin, emodin and others that the investigators have already identified~     as conferring anti-inflammation related activities) for inhibition of TS/A and 4T1 tumor~     growth and specific effects on inflammation-associated, cellular and molecular functions of~     stromal immune cells, fibroblasts and MDSCs. When potent and specific anti-tumor effects are~     detected, the investigators will extend our study to a three-dimensional collagen/Matrigel~     culture system for ex-vivo study focusing on the stromal cell-mediated or -associated~     anti-tumor effects of TS/A or 4T1 cells, using the organoid tissue culture systems the~     investigators have previously developed in our laboratory (JNCI, 1979; Cancer Res., 1981).~     The investigators will establish reconstituted TS/A or 4T1 tumor cells with the stromal~     immune cells in a co-cultivation system. When the investigators have achieved demonstrable~     success, the investigators will extend the mouse system to human breast cancers (including~     primary and metastatic tumors) by a close collaboration (which the investigators have already~     established) with Drs.~   "
174006|NCT01287455|"~     Research Title: The effect of vitamin D replacement on airway reactivity, allergy and~     inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic~     children.~      Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions as an~     immunomodulator. Asthma disease involves inflammatory process in the lower respiratory tract~     and airway hyperreactivity.~      Aim: To assess the effect of Vitamin D replacement on airway reactivity, and allergy and~     inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic~     children.~      Design: Double blind placebo control prospective study comparing the effect of Vitamin D~     replacement and placebo on airway reactivity, allergy and inflammatory mediators in exhaled~     breath condensate in asthmatic pediatric population with vitamin D deficiency.~      Participant selection: The study group will consist of pediatric patients (age 6-18 years)~     followed and treated at the Pediatric Pulmonary Unit at the investigators hospital.~      Patients with mild-moderate asthma with low or insufficient vitamin D levels that are~     currently not receiving anti-inflammatory treatment will be recruited.~      Sample size: 60 participants in the two groups (30 receiving Vitamin D and 30 receiving~     placebo).~      Intervention: Vitamin D (14000 units) or placebo will be provided in a similar appearance~     preparation once weekly for 6 weeks between visit two and three.~      Three visits will be conducted. Each subject will undergo evaluation including a respiratory~     questionnaire (visit 1), methacholine challenge test with determination of PC20 (visit 1 or 2~     and visit 3), exhaled nitric oxide (eNO) (visit 2, 3), and exhaled breath condensate (EBC)~     (visit 2,3). Venous blood will be analyzed for complete blood count + eosinophils (visit 1,~     3), IGE levels (visit 1, 3), and Vitamin D levels (visit 1, 3). Prick skin test for inhaled~     allergens will be performed (visit 2, 3).~      Primary end point: Airway reactivity as assessed by methacholine challenge test.~      Secondary outcome parameters: All other parameters are the secondary end points.~   "
174007|NCT01287442|"~     It is well established to assess the functionality of a filtering bleb by intraocular~     pressure (IOP), either as an absolute value or as a percent reduction, and by the need of~     additional antiglaucoma drugs. It is also possible to evaluate the appearance of a bleb by a~     clinical score, e.g. the Wuerzburg bleb classification score (WBCS). The purpose of this~     study was to find out whether there is a correlation between clinical findings, in particular~     IOP and the WBCS.~      100 eyes within two years after trabeculectomy were included into the study. Using colour~     photographs the filtering bleb was evaluated according to the WBCS from two different~     examiners, both on different levels of clinical experience. WBCS = 1 indicates poor bleb~     appearance, WBCS = 15 indicates optimal bleb appearance. At the same time, clinical findings~     like intraocular pressure, best corrected visual acuity, slit lamp biomicroscopy and medical~     history were taken by another examiner.~        -  Trial with surgical intervention~   "
174008|NCT01287429|"~     Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED);~     discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma.~     The initial diagnostic work-out is often not very accurate in defining the etiology and the~     underlying pathophysiology. In the last years, lung ultrasound (US) has emerged as a useful~     real-time bedside diagnostic tool in the critical patient. The aim of this study was to~     evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung US,~     performed by emergency physicians at the time of patient first presentation to the ED, in~     identifying cardiac causes of acute dyspnea.~   "
174009|NCT01287416|"~     Primary Hypothesis: Participants in the Applied Suicide Intervention Skills Training (ASIST)~     gatekeeper training will be significantly more likely to have increased knowledge and~     preparedness to help people with suicidal ideation than participants who receive the~     resilience retreat.~      Secondary Hypotheses:~        1. Participants in ASIST gatekeeper training will not have higher levels of~          post-intervention distress or suicidal ideation compared to the resilience retreat.~        2. High levels of distress, grief, and alcohol abuse will significantly impact on the~          learning and retention of suicide intervention skills.~   "
174012|NCT01287377|"~     The primary purpose of this study is to test the feasibility of sending pre-cessation~     nicotine patches and to examine the effects associated with the pre-cessation treatment~     phase. Specifically, this study aims to:~        1. See if subjects will use pre-cessation nicotine patches.~        2. See if subjects in the pre-cessation nicotine patches go on to get more nicotine~          patches.~        3. See if pre-cessation treatment with nicotine patches leads to a decrease in number of~          cigarettes smoked per day.~        4. See if sending 2-weeks' worth of patches is helpful to the quitting process.~   "
174013|NCT01287364|"~     This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or~     older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a~     novel-patient administered assessment of treatment satisfaction with and preference of an~     Internasal Corticosteroid (INCS)~   "
174014|NCT01287351|"~     This study will compare the absolute and relative effectiveness and cost-effectiveness of~     asthma management in patients in the USA on inhaled corticosteroid (ICS) maintenance therapy~     as HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone~     propionate (FP) pMDI. .~   "
174015|NCT01287338|"~     The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms~     (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.~   "
174016|NCT01287325|"~     This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients~     with COPD and cough.~   "
174017|NCT01287312|"~     Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure.~     Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported~     with a good results ( 4 cases). There were no serious advers effects.~      The investigators want to use also TCA 50% for endoscopic repair in children with recurrent~     TEF.~   "
174018|NCT01287299|"~     The purpose of the study is to determine if a low glycemic load diet reduces the gain of body~     fat and insulin resistance during the last half of pregnancy in obese women.~   "
174019|NCT01287286|"~     The purpose of this study is to investigate if food supplements,Antrodia cinnamomea, could~     minimize the gastrointestinal symptom of cancer patients with chemotherapy.~   "
174020|NCT01287273|"~     Frozen- thawed embryos obtained by IVF treatments are transferred to the uterus immediately~     following thawing or after incubation for additional 24-72 hours. The two methods are routine~     in IVF laboratories. In this study the investigators would like to compare between these two~     methods in terms of implantation rate, pregnancy rate and delivery.~   "
174021|NCT01287260|"~     This is a clinical study evaluating the superiority in efficacy and assess safety and~     tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with~     BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who~     are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.~   "
174022|NCT01287247|"~     This is a prospective, observational trial evaluating the real world use of~     Xeomin®(incobotulinumtoxinA). Physicians may enroll patients who are eligible to be treated~     with a botulinum toxin for cervical dystonia or blepharospasm based upon their clinical~     experience. The physician must have chosen to treat the patient with Xeomin®~     (incobotulinumtoxinA) prior to and independent of enrollment in this study. Physicians may~     choose to treat their subjects with up to 2 treatment cycles (approximately 6 months/subject)~     of Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her~     clinical experience with botulinum toxin. According and dependent on clinical practice, the~     investigators expect that subjects will be seen by the investigator for an average of 3~     visits (two treatment cycles).~   "
174023|NCT01287234|"~     The purpose of this study is to evaluate an external device (SonR sensor) that is capable of~     detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart~     and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization~     therapy defibrillator (CRT-D) device may be determined. The investigators will then compare~     the timing settings suggested by SonR to the settings suggested from the echocardiogram. The~     objective of this study is to determine if differences exist between these different methods~     of timing the contractions of the top and bottom chambers of the heart and if the SonR signal~     is able to produce results similar to those of an echocardiogram.~   "
174024|NCT01287221|"~     The purpose of this study was to determine whether Rifampicin was effective in slowing or~     reversing the progression of multiple system atrophy (MSA). Research studies indicate that~     there is an abnormality in protein synthesis and structure in parts of the brain responsible~     for MSA (protein misfolding) and the drug Rifampicin could potentially prevent or reverse~     this protein alteration. The study was done on participants with early MSA. The study~     consisted of taking the drug 2 times a day for 12 months. Participants underwent an~     evaluation of symptoms and function and will underwent a neurologic examination at the~     beginning of the study, at 6 months and at 12 months. They were also be contacted at 3 and 9~     months by telephone. Studies were done at 10 participating sites.~   "
174025|NCT01287208|"~     The main objective of this study is to test an intervention to increase the physical activity~     of medical residents, an employee population with little time for exercise. Specifically, the~     aims of this study are:~        1. To determine if providing medical residents with an activity device that measures steps,~          distance, and calories burned and tracks this information over time on a website~          increases residents' physical activity levels as measured by number of steps per day~          compared to a control group using a blinded activity device (no feedback).~        2. To determine if an unblinded team competition using the activity device directly~          following the randomized phase increases residents' activity level compared to baseline.~        3. To determine if activity level is associated with change in weight during the residency~          year.~        4. To determine if the average hours of sleep per week is associated with changes in weight~          and with activity level.~   "
174026|NCT01287195|"~     This study will assess the safety and efficacy of orally delivered short-term OKT3 in~     participants with active ulcerative colitis.~   "
174027|NCT01287182|"~     This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness~     in Assessing the Risk Factors of Atherosclerosis.~   "
174077|NCT01286519|"~     The purpose of this study is to measure the level of medicines found in body fluids such as~     blood, urine, spinal fluid of children.~   "
174028|NCT01287169|"~     We intend to conduct a pilot study designed to measure BPA levels before and after~     occupational exposure to thermal paper used in cash registers. We will recruit cashiers from~     a local commercial store that is currently still using BPA-laden thermal paper and plans to~     switch to BPA-free paper in the near future. The study uses a within-subject comparison~     design, using serum and urine samples to determine whether BPA is detectable in the study~     population at sufficient levels to measure differences in paired samples. Two phases of~     sample collection are proposed: Phase I - collecting paired samples on two separate occasions~     before the implementation of BPA-free thermal paper use in cash registers; and Phase II -~     collecting paired samples on two separate occasions after the implementation of this change~     in thermal paper.~   "
174029|NCT01287156|"~     Background:~      - The Center for Neuroscience and Regenerative Medicine is working to improve physicians'~     understanding of brain injury. More information is needed on traumatic brain injury (TBI),~     especially how well a person recovers from TBI and how the brain changes over time in people~     with TBI. To conduct this research, the center is sponsoring a number of research studies on~     TBI and is interested in evaluating individuals with TBI or post-concussive syndrome to~     determine if they might be eligible for future studies.~      Objectives:~      - To develop a pool of individuals with traumatic brain injury and post-concussive syndrome~     for future research studies.~      Eligibility:~      - Individuals at least 18 years of age who have symptoms of or have been diagnosed with~     traumatic brain injury or post-concussive syndrome and are willing to participate in future~     studies.~      Design:~        -  Participants will be screened with an initial telephone interview, and will be asked to~          come to the National Institutes of Health for an in-person screening visit.~        -  At the screening visit, participants will provide a medical history, have a physical~          examination and complete a study questionnaire on their TBI and its symptoms, including~          how the injury occurred, when it occurred, and any previous brain-related injuries.~        -  Subjects may also return for a second visit at the NIH CC if eligible.~        -  Each visit may involve blood samples, an MRI scan, and a series of tests to evaluate~          brain function.~        -  Participants will also provide contact information to enable researchers to contact them~          for future studies.~   "
174030|NCT01287143|"~     Background:~      - Fever is a common symptom of illness, but it can involve many signs (a signal that~     something is not right in the body that can be seen by others, such as vomiting) and symptoms~     (a signal that something is not right in the body that are felt only by the person, such as~     pain) that may differ depending on the type of illness involved. Researchers are interested~     in studying individuals who have a fever to examine how often these signs and symptoms are~     experienced by patients.~      Objectives:~      - To identify and evaluate the signs and symptoms of fever and examine their frequency in~     individuals who have fever.~      Eligibility:~      - Individuals at least 8 years of age who are admitted to the NIH Clinical Center and have a~     fever (body temperature of at least 38 degrees Celsius/100.4 degrees Fahrenheit).~      Design:~        -  Participants will be screened upon admission to the NIH Clinical Center.~        -  Researchers will review the Clinical Center admission records.~        -  Participants will complete a 15- to 20-minute survey with questions about how they are~          feeling and what symptoms they have experienced before, during and after an episode of~          fever.~   "
174031|NCT01287130|"~     Background:~      - The experimental cancer treatment drug AZD6244 has been shown to block signals that tell~     cancer cells to grow. Cetuximab, a drug approved to treat cancer of the head, neck, colon,~     and rectum, also blocks signals that tell cancer cells to grow. Researchers are investigating~     the highest safe dose of AZD6244 to give with cetuximab, and will also investigate the~     effectiveness of this drug combination in individuals who have colorectal cancer that~     involves a particular protein known as the K-RAS protein. Cetuximab is not used to treat~     colorectal cancer with K-RAS tumors because it has not been shown to be effective, but~     researchers believe that adding AZD6244 to cetuximab may improve how well cetuximab works,~     even in people with K-RAS tumors.~      Objectives:~        -  To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for~          solid tumors that have not responded to standard treatment.~        -  To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for~          colorectal cancer that involves the K-RAS protein and has not responded to standard~          treatment.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with solid tumors that have~          not responded to standard treatment.~        -  Individuals at least 18 years of age who have been diagnosed with colorectal cancer that~          has not responded to standard treatment.~      Design:~        -  This protocol will involve two separate studies: an initial study to establish the~          highest safe and effective dose of AZD6244 and cetuximab in individuals with solid~          tumors, and an expansion study of AZD6244 and cetuximab in individuals with colorectal~          cancer involving the K-RAS protein.~        -  Participants will be screened with a full medical history and physical examination,~          blood samples, imaging studies, and other tests as required by the researchers.~        -  AZD6244 is a capsule to be swallowed once or twice a day, every day, with water on an~          empty stomach. Cetuximab will be given intravenously once a week, over 2 hours for the~          first dose and over an hour for every following dose. This combination of daily AZD6244~          and weekly cetuximab will be repeated in 28-day cycles of treatment. Participants will~          keep a diary to record the time of taking AZD6244 each day, as well as any side effects.~        -  Participants will have frequent blood tests and other exams during the first cycle of~          treatment, up to five visits to the National Institutes of Health (NIH) and other visits~          to their local doctor to in the first 28-day cycle.~        -  During subsequent cycles, participants will have four visits to NIH and four visits to~          your local doctor for examinations, blood tests, and imaging studies.~        -  Participants may continue to receive the AZD6244 with cetuximab for up to 6 cycles,~          until the tumor grows, unacceptable side effects development, or the participant or~          participant's doctor decides to stop participation. There will be a final study visit~          that repeats the procedures performed during the screening visit.~   "
174032|NCT01287117|"~     The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate the efficacy and safety of omalizumab administered~     subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged~     12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite~     standard-dose H1 antihistamine treatment.~   "
174040|NCT01287013|"~     Background:~      - Procedures that use medical tools in or near a possible abnormality in the body often use~     computed tomography (CT) scans to locate the abnormality and guide the path that a needle~     will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two~     new procedures being studied to help guide the needle. Xperguide is software that uses CT~     images to help the doctor choose the needle path. EM tracking uses special medical tools with~     miniature coils that act like a Global Positioning Satellite (GPS) device to show the~     location of the needle in the body. Xperguide and EM tracking have been used in humans and~     have good results, but they have not been compared with each other and regular CT to~     determine whether they are better than the standard approach.~      Objectives:~      - To compare the results of Xperguide, electromagnetic tracking, and regular computed~     tomography during a guided percutaneous procedure.~      Eligibility:~      - Individuals at least 18 years of age who are required to have a CT-guided percutaneous~     procedure.~      Design:~        -  Participants will be screened with a physical examination and medical history, and the~          results of any previous imaging studies will be examined before study enrollment.~        -  After a pilot phase, the study will involve two phases to compare the results of the~          different procedures. The first phase will involve comparing Xperguide to CT, and the~          second will involve comparing Xperguide to EM tracking.~        -  Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have~          Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have~          repeated procedures (like a biopsy before and after chemotherapy) will be randomized for~          the first procedure and the second procedure will be done using the other method.~        -  Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have~          Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have~          repeated procedures (like a biopsy before and after chemotherapy) will be randomized for~          the first procedure and the second procedure will be done using the other method.~        -  Standard post-procedure followup care will be given after the study procedure is~          completed.~   "
174092|NCT01286324|"~     The purpose of this study is to determine if an herb called chamomile can help to treat~     insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of~     time that you sleep and/or improving the quality of your sleep. The study will also be~     looking at the effect of chamomile on day time fatigue and functioning.~   "
174033|NCT01287104|"~     Background:~        -  Bone marrow stem cells, which are found in the bone marrow and blood stream, can be~          collected and transplanted to treat a variety of types of cancer in a process known as~          hematopoietic stem cell transplantation (HSCT). When stem cells are taken from one~          person, most commonly a sibling or a family member, and then given to another person,~          this is referred to as allogeneic HSCT. Allogeneic HSCT has proven to be an especially~          effective treatment for patients with some types of cancers of the blood (leukemia) and~          certain solid tumors. The transplanted stem cells travel to the patient's bone marrow~          and begin producing normal blood cells, and also attack patient s cancer cells.~        -  Because allogenic HSCT does not always prevent the cancer from returning, researchers~          are interested in determining whether another type of immune cell taken from the stem~          cell donor s white blood cells, called a natural killer (NK) cell, can be given in~          addition to the HSCT to help fight the tumor. In the laboratory, NK cells have been~          shown to kill tumor cells, but it is not yet know if this will occur when given to~          patients after HSCT.~      Objectives:~        -  To determine the safety, effectiveness, and immune system response of giving NK white~          blood cells to individuals who have received allogeneic HSCT.~        -  To identify possible side effects from the treatment.~      Eligibility:~        -  Donors: Stem cell donors whose blood matches one of the recipients on six out of six HLA~          (blood immune marker) types. The donor may not be the identical twin of a recipient.~        -  Recipients: Individuals between 4 and 35 years of age who have been diagnosed with~          pediatric solid tumors that have not responded to standard treatment, or individuals~          between 4 and 18 years of age who have been diagnosed with leukemia that has not~          responded to standard treatment.~        -  Other eligibility requirements which include a physical exam and blood laboratory~          evaluation are included to make sure it is safe for both the donor to donate and the~          recipient to undergo the transplant procedure.~      Design:~        -  Donors and recipients will be screened with a full medical history and physical~          examination, and will provide blood and urine samples; recipients will have tumor~          imaging studies and other tests as required by the researchers.~        -  Donors:~        -  Participants will receive filgrastim injections (to stimulate the bone marrow) for 1~          week to make stem cells travel from bone marrow to blood.~        -  Participants will provide stem cells and NK cells through apheresis.~        -  Recipients:~        -  Participants will have three cycles of chemotherapy to treat the underlying cancer and~          weaken the immune system so that it will accept the donor cells.~        -  Participants will then receive preparative chemotherapy for the transplant and two days~          after the last dose of chemotherapy, participants will have allogenic HSCT using the~          donated stem cells.~        -  Participants will receive an infusion of NK cells on days 7 and 35 after the HSCT. -~          Participants will remain in the hospital for monitoring after the HSCT and NK cell~          treatments, and will be followed closely as outpatients for the first 6 months after the~          transplant and then less frequently for at least 5 years.~   "
174034|NCT01287091|"~     This will be a single-center, open-label, 3 part study. The study is designed to determine~     the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting~     conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980~     tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the~     presence or absence of a high-fat meal.~   "
174035|NCT01287078|"~     Background:~      - Bronchiolitis obliterans or bronchiolitis obliterans syndrome is a lung disorder that~     occurs as a complication of either lung transplantation or bone marrow/blood stem cell~     transplantation. In bronchiolitis obliterans, the body s white blood cells or white blood~     cells from the transplant attack the lungs, which leads to the destruction of lung tissue,~     and ultimately, scarring or fibrosis of the lung tissues. When a patient develops fibrosis of~     the lungs or bronchioles, the lungs no longer work properly, which causes difficulties with~     breathing that lead to a diminished quality of life and an increased risk of death. Treatment~     typically involves immunosuppressive therapy such as oral cyclosporine or steroid therapy,~     but these treatments are only marginally effective and can cause significant toxicities and~     increase the risk of infections. Inhaled cyclosporine (CIS) achieves higher concentrations of~     cyclosporine in the lungs and lower concentrations of cyclosporine in the blood than oral~     cyclosporine. Therefore, it could have advantages over conventional oral immunosuppressive~     therapies used to treat this disorder. Researchers are interested in testing whether inhaled~     cyclosporine therapy could be used as a safe and effective treatment for bronchiolitis~     obliterans or bronchiolitis obliterans syndrome occurring after bone marrow/blood stem cell~     or lung transplants.~      Objectives:~      - To evaluate whether inhaled cyclosporine (CIS) can improve or stabilize lung function and~     quality of life in individuals with bronchiolitis obliterans.~      Eligibility:~      - Individuals between 10 and 80 years of age who have been diagnosed with bronchiolitis~     obliterans or bronchiolitis obliterans syndrome after blood or lung transplants.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests, lung function tests, imaging studies, and quality of life~          questionnaires.~        -  Participants will take cyclosporine inhalation solution through a nebulizer. The~          nebulizer generates a mist of cyclosporine inhalation solution (CIS), which is then~          breathed in through a mouthpiece. The process takes approximately 20 minutes. The~          solution will be provided in single-use vials.~        -  Participants will continue to take all medications for post-transplant care as required~          by their doctor and the study researchers. Attempts will be made to reduce the doses and~          types of immunosuppressants given to participants on the study, as long as the treatment~          continues to produce improved or stable lung function.~        -  Participants will have study visits every 3 weeks with blood and urine tests, lung~          function tests, and imaging studies. Participants will also complete quality of life~          questionnaires as directed. Treatment will continue for a minimum of 18 weeks, followed~          by a final follow-up visit 2 weeks after the end of the study.~        -  Participants who benefit from the inhaled cyclosporine (CIS) may continue to receive~          further therapy with inhaled cyclosporine at the end of the study by participation in a~          separate study extension.~   "
174036|NCT01287065|"~     This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way~     crossover study in patients with persistent bronchial asthma to compare the effect of morning~     (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder~     on lung function. Following screening there will be a run-in period of 14 days. There will be~     3 treatment periods; drug at AM, drug at PM and placebo, which will last for 14 days each~     with a 14-21 day washout period between starting the next. Key assessments include; forced~     expiratory volume in one second (FEV1), peak expiratory flow (PEF), vital signs,~     electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests.~   "
174037|NCT01287052|"~     BACKGROUND Migraine headaches account for 8-18% of all headaches seen in pediatric emergency~     rooms. Standard treatment includes IV pain medications, anti-emetics, and IV fluids. Nitrous~     oxide has analgesic properties similar to those of opioids and is easy to administer. It has~     been shown in two small studies to be effective in treating migraine headaches.~      RESEARCH QUESTION Does nitrous oxide act as a safe, less invasive, and effective treatment of~     acute migraine headaches in children and adolescents presenting to an Emergency Department?~      DESIGN This is a prospective non-randomized self-controlled study. Repeated measures will be~     taken to examine change in pain scores before and after nitrous oxide treatment.~      METHODS Each participant will be given nitrous oxide until he/she reports a pain score of~     zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of~     0-10 before the treatment and after the treatment at multiple time-points.~   "
174038|NCT01287039|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in~     patients with eosinophilic asthma.~   "
174039|NCT01287026|"~     Background:~      - Currently, heart catheterization procedures are guided by X-rays. Researchers are~     developing new techniques to perform heart catheterization without the use of X-rays by~     investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses,~     researchers are interested in performing a part of the standard X-ray catheterization~     procedure using MRI on individuals who are scheduled to have heart catheterization.~      Objectives:~      - To examine the safety and feasibility of right-heart catheterization using MRI-guided~     catheters.~      Eligibility:~      - Individuals at least 21 years of age who are undergoing a medically necessary heart~     catheterization procedure.~      Design:~        -  The research MRI procedure will be performed either before or after standard X-ray~          guided heart catheterization.~        -  Participants will be transferred from an X-ray table onto an MRI table and advanced into~          the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood~          pressure and blood oxygen levels in the heart, and MRI scanning will be performed for~          approximately 30 minutes.~   "
174230|NCT01284517|"~     Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression.~     This clinical study is designed to test the hypothesis that Lurasidone in combination with~     either Lithium or Divalproex is effective among patients with bipolar I depression.~   "
174041|NCT01287000|"~     Background:~        -  There has been little research on the long-term health effects from oil spills, even~          though at least 10 percent of all oil tanker spills between 1970 and 2009 have affected~          coastal populations. The Deepwater Horizon disaster, with its release of approximately 5~          million barrels (~680,000 tons) of crude oil into the Gulf of Mexico, is far larger than~          any of the individual tanker spills. Given the magnitude of this spill and the scope of~          the potential exposures, including the 55,000 workers involved in clean-up efforts and~          countless residents of the affected areas, researchers are interested in monitoring Gulf~          clean-up workers to understand the adverse consequences of oil spills in general.~        -  The Gulf Long-term Follow-up Study will investigate health effects associated with the~          clean-up activities following the Deepwater Horizon disaster in the Gulf of Mexico on~          April 20, 2010. More than 100,000 persons completed safety training in preparation for~          participation in clean-up activities related to the spill. Many of these individuals~          participated in active clean-up efforts, but others did not. Exposures among persons~          involved in clean-up range from negligible to potentially significant, especially for~          workers involved in tasks associated with direct exposure to crude or burning oil, or to~          chemical dispersants. However, prediction of adverse health effects is not possible~          because the long-term human health consequences of oil spills are largely unknown. In~          addition to the oil itself, the widespread economic and lifestyle disruption caused by~          the oil spill may contribute to mental health problems among this population.~      Objectives:~      - To investigate potential short- and long-term health effects associated with clean-up~     activities and exposures surrounding the Deepwater Horizon oil spill.~      Eligibility:~      - English-, Spanish-, and Vietnamese-speaking workers and volunteers at least 21 years of age~     engaged or potentially engaged in oil spill clean-up operations in the Gulf of Mexico, or who~     lived in affected areas (Louisiana, Mississippi, Alabama, and Florida coastal regions).~      Design:~        -  Participants will be divided into groups of those who performed oil-spill~          clean-up-related work ( exposed ) and those who did not engage in clean-up-related work~          ( unexposed controls).~        -  Participants will be screened with a full medical history and physical examination, as~          well as an interview to determine the nature of their potential exposure.~        -  Participants will provide blood, hair, toenail, urine, and saliva (spit) samples.~          Participants may also have a lung function exam.~        -  Participants will have researchers collect dust from their homes by using wipes and~          special vacuum bags.~        -  Participants will also provide detailed contact information, including their Social~          Security number, to be contacted in the future for long-term health follow-up~          appointments. These appointments will include 30-minute telephone interviews every 2~          years.~   "
174042|NCT01286987|"~     This is a single-arm, open-label study to assess the safety, pharmacokinetics,~     pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors~     with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation~     phase in which the maximum tolerated dose will be defined, and a dose expansion phase.~   "
174043|NCT01286974|"~     A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients~     with advanced solid tumors.~   "
174044|NCT01286961|"~     As the duration of the interval between the time of last preparation-agent dose and the start~     of the colonoscopy is increasing, the quality of bowel preparation will be worse.~   "
174045|NCT01286948|"~     It has been proposed that levonorgestrel (LNG) in a vaginal gel could be used as an 'on~     demand' contraceptive when used before coitus. Levonorgestrel was selected as it is a~     component of many approved oral contraceptive pills and also it is the active agent in Plan~     B, an FDA-approved regimen for emergency contraception (EC). In previous studies it was~     demonstrated that an LNG vaginal gel was absorbed and was effective in preventing follicular~     rupture. The overall proportion of cycles with lack of follicular rupture within 5 days of~     LNG administration or with ovulatory dysfunction (follicle rupture preceded by an inadequate~     LH surge) was 96% for LNG gel and 39% in the inert gel cycles (control group).~   "
174046|NCT01286935|"~     The purpose of this study is to determine the long-term efficacy and safety of two doses of~     safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with~     idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable~     dose of levodopa.~   "
174047|NCT01286922|"~     The Insulin Sensitivity using Aerobic Interval Conditioning (ISAIC) trial will compare~     traditional aerobic training (AER) to interval training (INT) in sedentary, overweight/obese~     men at risk for pre-diabetes. The investigators will randomly assign 42 individuals to 3~     months of monitored exercise using a randomly assisgned design where participants will~     exercise under either AER or INT training conditions. The AER training condition will be~     consistent with standard-of-care recommendations. Exercise training will entail one 3-month~     blocks of either AER or INT. Training will consist of 1) a 1-month ramp up period, 2) 1-month~     of traditional aerobic training and 3) 1-month of either continued AER or INT.~   "
174048|NCT01286909|"~     A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in~     Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).~   "
174049|NCT01286896|"~     The purpose of this prospective study is to determine the safety and feasibility of~     pharmacokinetically (PK) guided dosing of sunitinib in 30 patients.~      At day 15 ± 1day, day 29 ± 1day and after 8 weeks ± 1day of sunitinib treatment sunitinib and~     SU12662 trough levels will be measured. Depending on the sunitinib and SU12662 trough levels~     (and toxicity) dose adjustments will be made.~   "
174050|NCT01286883|"~     The study will enroll patients with metastatic colorectal cancer receiving chemotherapy. A~     total of approximately 22 cc of blood will be drawn during various chemotherapy infusions.~     Additional proposed laboratory studies may unravel important biological insights into the~     relationship of circulating tumor cell genomic and genetic profiles as they compare to the~     primary tumors. Additionally the investigators hope to gain an understanding of potential~     subgroups of patients that have very high numbers of circulating tumor cells or those with~     early relapse of circulating tumor cells after early reduction of circulating tumor cell~     numbers.~   "
174051|NCT01286870|"~     While Core Becker patient follow-up is being completed this Continued Access Study is~     designed to enroll patients at a limited rate per month to allow for continued physician and~     patient experience with the device.~      Up to 12 patients per month at sites across the United States will be enrolled in this~     research study. These patients will be implanted with the Becker 25 or Becker 50~     Expander/Breast implant and monitored for 10 years for safety.~   "
174052|NCT01286857|"~     The aim of the investigation is to evaluate the function of two new device parts to be used~     in a NPWT system; an on-top suction device intended to transport exudate from the wound and a~     silicon cover film intended to fixate the wound filler and seal tight to the skin in order to~     keep a moist environment.~   "
174053|NCT01286844|"~     GSK2190915 is under development as an oral controller for the treatment of adult and~     pediatric asthma. This study is an open label, single and repeat dose escalation study, in~     children with asthma. It will investigate the pharmacokinetics of GSK2190915 in children,~     aged from 1 to 12 years old inclusive, to determine how the dosage regimen for GSK2190915 in~     a pediatric population should be adjusted to achieve approximately the same level of systemic~     exposure that is safe and effective in adults.~   "
174054|NCT01286831|"~     The purpose of this study is to characterise the metabolic disposition of radiolabelled~     GW642444 when administered orally.~   "
174056|NCT01286805|"~     The purpose of this study is to determine whether the use of a lumbar plexus block for~     arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in~     treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the~     total amount of pain medication needed, and therefore reduce the side effects of these~     medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar~     plexus block will significantly reduce patients' postoperative pain.~   "
174057|NCT01286779|"~     The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery~     over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of~     life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately~     severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric~     study 251101.~   "
174058|NCT01286766|"~     Number of patients planned The study adopted two parallel phase II studies, with the same P1~     and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of~     interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively.~     Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26~     patients were required per arm to achieve the desired statistical power. Finally, taking a~     20% drop-out rate into consideration, the overall number of enrolled patients was 62.~   "
174059|NCT01286753|"~     This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib~     (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC)~     positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants~     will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or~     unacceptable toxicity occurs.~   "
174060|NCT01286740|"~     The purpose of this Phase 2b study was to evaluate the efficacy and safety of the~     emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching~     from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at~     Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months~     prior to study start, were experiencing safety or tolerability concerns (in particular,~     EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.~   "
174061|NCT01286727|"~     The objective of the study is to evaluate the safety and activity of a investigational drug~     in improving renal function in patients who have undergone renal transplantation and have~     signs and symptoms of significant renal injury and are at risk for dialysis.~   "
174062|NCT01286714|"~     Anastomotic fistula following bariatric surgery are lifethreatening complication with a 37.5%~     mortality rate. All the modalities for bariatric surgery are involved in this type of~     complication, but Sleeve gastrectomy is the main surgery responsible for the frequency and~     the severity of the fistula. The management of this complication is still controversial and~     potentially lethal. The average number of endoscopic sessions was 4 (range 2-11). The closure~     could be obtained within a mean time of 88 days (range 6-216 days). Therefore endoscopic~     management has to be improved to reduce the duration of the treatment and the number of~     endoscopic sessions. OTSC clips could help to improve the endoscopic management because of a~     more prehensive, deeper and larger suture area.~   "
174063|NCT01286701|"~     The purpose of this study is to compare the rate and extent of absorption of terbinafine~     hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet~     under fed conditions.~   "
174064|NCT01286688|"~     The purpose of this study is to compare the rate and extent of absorption of terbinafine~     hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet~     under fasting conditions.~   "
174065|NCT01286675|"~     Eltrombopag may improve the cell collection available for Autologous Stem Cell~     Transplant(ASCT). The overall goal is to determine if adding Eltrombopag to the standard ASCT~     will increase the number of blood cells collected and reduce the number of times blood needs~     to be collected. This study will also determine the highest dose of Eltrombopag that can be~     used without causing serious side effects.~   "
174066|NCT01286662|"~     The purpose of this study is to assess the long-term outcome in a cohort of Gardner-Syndrome~     patients receiving prophylaxis and treatment for intestinal and non-intestinal tumors.~   "
174067|NCT01286649|"~     The primary purpose of this study is to assess the safety of performing injections of human~     autologous hair follicle cells. The study will also measure the impact these injections will~     have on hair growth.~      20 patients will be selected for participation in this study (10 males and 10 females) based~     on their health status, current/past medications, and ability to adhere to protocol-related~     requirements. All patients will have evidence of mild to moderate androgenetic alopecia (AGA)~     involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood (male)~     scales.~      At the first visit and after completing informed consent, patients provide a blood sample~     that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week~     before having a biopsy from the back of their scalp. The provided scalp biopsy is then~     processed to isolate hair follicle cells which are then replicated. Patients return to the~     clinic for injections of their own replicated cells (autologous cells) in medium (verum) and~     medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of~     the safety/tolerability of these injections will take place over the next 60 months both at~     in-clinic visits and telephone follow-up visits. At these visits patients will have their~     overall health assessed as subjective and objective assessments of the areas that were~     injected either with verum or control. During the first 24 months of follow-up, digital~     images will be taken of the scalp and of the two treatment areas injected with either verum~     or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2~     female) at each time point will provide biopsies of the injection sites for histopathological~     analysis. At the 60 month time point, any patients not previously providing biopsies for~     histopathological analysis will provide biopsies. Total duration of patient participation is~     approximately 63 months.~   "
174068|NCT01286636|"~     The investigators have developed a simple, accurate, and a point-of-care, computer-based~     clinical decision support system (CDSS) not only to detect the presence of sleep apnea but~     also to predict its severity. The CDSS is based on deploying an artificial neural network~     (ANN) derived from anthropomorphic and clinical characteristics.~      The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be~     diagnosed with the use of ANN without undergoing a sleep study, and that empiric management~     with auto-CPAP has similar outcomes to those who undergo a formal sleep study.~   "
174093|NCT01286311|"~     The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular~     disease quality improvement system that couples EMR-based patient identification with~     individually tailored patient messages. The study will test the hypothesis that that a~     tailored patient-directed approach to cardiovascular risk reduction integrated into patients'~     primary care delivery site will improve control of elevated low-density lipoprotein~     cholesterol and other card iac risk factors more than routine care alone for patients at~     intermediate or high risk for cardiovascular disease.~   "
174069|NCT01286623|"~     The treatment of HIV and the tests performed for HIV care have changed over the last 20~     years. However, improvement of management of HIV-infected subjects is still warranted,~     especially as the HIV-infected population is aging. Therefore, this study will involve the~     collection and analysis of clinical information obtained from subjects who are over 50 years~     of age. For example, patients' risk of heart disease will be measured and monitored by~     looking at blood tests and clinical data (such as blood pressure). This will allow~     researchers to understand if the current way of assessing the risk of future heart disease is~     the best one available for HIV-infected individuals. No genetic research will be done.~   "
174070|NCT01286610|"~     Vibration therapy is used for different indications in rehabilitation and sports medicine. So~     far, vibration therapy has not been investigated within the ICU setting. The investigators~     created this setting to show safety and applicability of vibration therapy in ICU patients.~     30 patients will be stimulated by vibration therapy on two separate days during their ICU~     stay. Three collectives of equal size will be observed: One with patients on mechanical~     ventilation without signs of infection or suspected intracranial pressure problems, a second~     one with patients on mechanical ventilation in addition to signs of systemic inflammation but~     absence of suspected intracranial pressure problems, and a third one with patients on~     mechanical ventilation, signs of systemic inflammation in addition to presence of controlled~     intracranial pressure problems. Typical parameters of hemodynamic status, intracranial~     pressure and energy metabolism will be recorded for a defined period of time before, during~     and after vibration therapy itself. Vibration therapy will be combined with protocol based~     physiotherapy.~      Our aim is to show the effects of vibration therapy in ICU patients and its safe~     applicability.~      ADDITION 06th of May 2011: Additionally we will perform euglycaemic hyperinsulinemic clamp~     and intervention on one day of ICU stay in 20 patients. Under clamp conditions we will~     perform a vibration therapy (ProMedVi Vibrosphere™) on patients' legs. On top we will perform~     electrical muscle stimulation (schwa-medico, MUSKELaktiv™) on one ventral upper leg,~     randomized chosen. Measuring the local skeletal muscle metabolism will be done by~     microdialysis in Vastus lateralis on both sides - comparing vibration therapy and vibration~     therapy combined with electrical muscle stimulation.~   "
174071|NCT01286597|"~     Lactose is a carbohydrate found in milk,and Lactase Deficiency (LD) is a condition in which~     the small intestine cannot digest this carbohydrate due to absent or insufficient amounts of~     lactase.Individuals with LD may be intolerant of lactose in the diet and experience abdominal~     cramps, bloating and diarrhea; however the response is variable.Some tolerate moderate~     amounts of lactose without adverse effect,whereas others experience severe symptoms in~     response to even small doses. These problems may be representative of wider issues regarding~     individual tolerance to diet containing ubiquitous poorly absorbed, fermentable carbohydrates~     (such as: fructose, fructans)and be relevant to symptom generated in patients with diarrhea~     predominant irritable bowel syndrome (D-IBS).~      This project will investigate the effects of diet,lifestyle stress and psychiatric dietary on~     the development of functional gastrointestinal symptoms. Lactose will be used to assess~     tolerance to dietary challenge, a test that is particularly relevant in a Chinese population~     with a high prevalence of lactase deficiency.~   "
174072|NCT01286584|"~     The aim of this study is to assess the efficacy of varenicline compared to placebo in tobacco~     dependent individuals who are undergoing concurrent treatment for alcohol dependence. As they~     will be inpatients and under 24 hour medical care for the first 21 days of treatment, or~     receiving outpatient treatment through the Alcohol Research and Treatment Clinic, this will~     allow for a comprehensive assessment of the safety of varenicline in this population with~     minimal risk of adverse consequences. The patients will continue their cessation treatment~     for an additional 10 weeks as outpatients through the Nicotine Dependence Clinic at CAMH.~     They will also be contacted at 6 months for follow-up.~   "
174073|NCT01286571|"~     The objective of this study is to investigate the effect of food on the relative~     bioavailability of a 50 mg BI 135585 XX tablet.~   "
174074|NCT01286558|"~     Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug~     alone, often a combination of two or more drugs is essential to achieve a sufficient~     antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination~     therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low~     dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the~     Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination~     (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure~     (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with~     T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.~      In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood~     pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination~     was shown (U07-3503-02). But the sponsor has no data that verifies this difference in~     Japanese patients.~      Thus, this clinical trial is being conducted to investigate the antihypertensive effect and~     safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients~     with essential hypertension. In this trial, a multi-centre, randomised, double-blind,~     double-dummy, active-controlled, parallel group comparison method is employed.~   "
174075|NCT01286545|"~     Long term data on efficacy and safety of anti-TNF treatment with infliximab in patients with~     ankylosing spondylitis (AS) beyond 5 years is lacking. These data are important because~     patients with AS usually are younger and withdrawal of anti-TNF therapy in these patients~     almost always leads to a disease relapse. Furthermore it is still unclear whether long term~     anti-TNF treatment in AS patients can inhibit radiographic progression. Patients who~     participated in the EASIC and the DIKAS trial respectively who were treated with infliximab~     within these studies for 7 and 10 years respectively are followed up by using clinical~     outcome parameters every 6 months assessing efficacy and safety of long term treatment.~     Furthermore radiographs of the spine, if done for clinical indication, are analyzed. It is~     hypothesized that anti-TNF treatment with infliximab is effective and safe over a time period~     of 9 and 12 years respectively and that long term anti-TNF therapy may inhibit radiographic~     progression of the spine.~   "
174076|NCT01286532|"~     This is a six-month non-interventional prospective study of various controller therapies in~     children with asthma in outpatient clinical practice.~   "
174078|NCT01286506|"~     Dialysis is used to control the fluid balance and metabolic state of patients with kidney~     disease. Control of the metabolic state, via electrolytes, can be monitored using labs that~     are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid~     removal is much more difficult. This study aims to determine whether changes in the blood~     pressure associated with breathing correlate with or predict intolerance to fluid~     responsiveness with continuous dialysis.~      We hypothesize that a measurement of changes in blood pressure with breathing called arterial~     pulse pressure variation may be able to predict the ability to remove fluid during continuous~     renal replacement therapy.~   "
174079|NCT01286493|"~     Booster rabies vaccination in HIV - infected patients who have ever received rabies primary~     vaccination could improve their immune response to this kind of vaccine.~   "
174080|NCT01286480|"~     The objective of this study is to evaluate the potential role of a cardiology clinic-based~     educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their~     parents, and to determine whether this intervention results in improved self-management~     skills (e.g., renewing medication prescriptions), teens having greater knowledge of their~     heart condition, and more teen and parent satisfaction with services. The results of this~     study will form the basis for a website that in turn may serve as an additional means of~     providing transition interventions. The results of this study may also be applicable to youth~     with other special health care needs.~   "
174081|NCT01286467|"~     This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on~     select solid tumors.~   "
174082|NCT01286454|"~     This Is A Study Of Bioavailability And Food Effect For Fesoterodine.~   "
174083|NCT01286441|"~     Nonclinical studies have shown sandalwood oil to have anti-inflammatory, anti-fungal,~     antiviral, and anti-bacterial activities. Previous clinical studies have shown East Indian~     Sandalwood oil to be promising as a treatment for common warts in adults and children.~      The primary objective of this study is to evaluate the efficacy and safety of 10%, 20%, and~     30% East Indian Sandalwood Oil (EISO) ointment compared with the ointment placebo~     administered twice daily (bid) for 12 weeks for the treatment of common warts (Verruca~     vulgaris).~   "
174084|NCT01286428|"~     This study was designed in two phases: Phase I is designed to confirm that the surgeon is~     able to perform accurate liver surface registration including standard liver features used as~     landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of~     comfort with the procedure.~      The surface of the liver will be manually swabbed with the study tracked laparoscopic probe~     with landmarks noted during data collection. After registration of the liver is obtained, the~     registration points obtained during this procedure will be evaluated by the surgeon by moving~     the tracked laparoscopic probe over the liver surface and evaluating the location of the~     tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The~     surgeon will accept or reject the registration accuracy.~      The hypothesis is that the surgeon will be able to successfully acquire liver surface~     registrations with a small learning curve for technique and will be able to proceed to Phase~     II of the study.~      Phase II contains the registration process included above but adds the additional process of~     tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder~     Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked~     and displayed on the Pathfinder three dimensional (3D) image.~      The surgeon will use ultrasound (US) guidance to locate tumor location during the~     laparoscopic procedure. The images collected during this process will be recorded by~     Pathfinder.~   "
174085|NCT01286415|"~     The purpose of this study is to compare group-administered Cognitive Processing~     Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress~     disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results~     of CPT exceed those of receiving a therapy that focuses on current problems rather than past~     trauma in a group format.~   "
174086|NCT01286402|"~     This study is designed to gather preliminary effectiveness and safety data on the use of~     bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This~     study will provide critical preliminary data in preparation for a larger, Phase III clinical~     trial.~   "
174087|NCT01286389|"~     Obesity has been associated with cognitive impairments, lower blood flow, metabolic activity~     and brain volume. Obesity in adulthood is a risk factor for Alzheimer's disease in the~     elderly. The mild cognitive impairment (MCI) is a condition that may precede dementia. We~     hypothesized that promotion of weight loss in obese people with MCI, through caloric~     restriction could lead to improvement in cognitive performance or reduction in the rate of~     decline and decreased risk of dementia. A sample of 80 patients aged ≥ 60 years, obese, with~     MCI, will be randomized to two groups that will be followed for 12 months. The control group~     will receive conventional medical care. The intervention group will receive nutritional~     counseling individually and in groups, aiming to promote weight loss through caloric~     restriction, and medical monitoring. Before and after intervention patients will be evaluated~     for anthropometry, body composition, physical performance, control of comorbidities,~     laboratory tests (glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor~     necrosis factor alpha, CRP), Genotyping apolipoprotein E, neuropsychological battery,~     questionnaires about activities of daily living, physical activity and diet.~   "
174088|NCT01286376|"~     Determine the effectiveness of symbiotic LACTOFOS containing FOS and probiotics against~     placebo in patients with a diagnosis of constipation, comparing the average number of weekly~     evacuations in 2 (two) groups for 30 days.~   "
174089|NCT01286363|"~     The purpose of this study is to evaluate chewing side preference, and lateral asymmetry of~     occlusal contact area and bite force of individuals with different craniofacial patterns~   "
174090|NCT01286350|"~     The purpose of this study is to see if a behavioral intervention for adolescents with type 1~     diabetes will improve adherence to T1D self-management activities and improve diabetes~     outcomes. We expect the intervention to improve diabetes outcomes when compared to usual~     care.~   "
174091|NCT01286337|"~     lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we~     hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection~     compared to the traditional surgical technique~   "
174094|NCT01286298|"~     Gingival enlargement is one of the most common soft tissue problems associated with fixed~     orthodontic treatment. The presence of orthodontic appliances impedes oral hygiene measures~     and alters the oral microbial ecosystem to a more pathogenic oral biofilm. Subsequent~     accumulation of plaque can contribute to development of chronic periodontal inflammation and~     can progress to gingival enlargement. Gingival enlargement inhibits hygiene measures, slows~     down orthodontic tooth movement and cause aesthetic and functional problems. Management of~     gingival enlargement by non-surgical periodontal treatment is considered to be most important~     and effective. Optimal plaque control can be maintained by meticulous brushing, flossing and~     professional scaling. However, motivation of maintaining oral hygiene can be disappointing in~     some patients. In cases that the enlarged gingivae became fibrous, surgical treatment can be~     considered.~      Traditionally, gingivectomy was performed using scalpel under local infiltration. Since the~     first laser designed for dental use was introduced in 1989. Laser technology has continuously~     developed over the years and there are now many different types of dental lasers using a~     variety of wavelengths, e.g. Diode, Er:YAG, CO2 and Er,Cr:YSGG lasers. In orthodontics,~     various intraoral soft tissues surgical procedures may be required frequently, e.g.~     gingivectomy, gingivoplasty, fraenectomy, exposure of unerupted/ impacted/ partially erupted~     teeth. The use of laser has becoming more popular because the advantages of laser therapy are~     good haemostasis, excellent visualization of the operating field, fewer intra- and~     post-operative complications, bactericidal effect, no suture required, less scars, and better~     pain control with effects of reduced use of local anaesthesia and analgesic. Diode laser unit~     has the merits of compact size and relatively low price. Gingivectomy by diode laser may~     become an effective adjunctive treatment in orthodontic practice.~      The aim of this study was to evaluate the clinical effectiveness of diode laser in the~     management of gingival enlargement related to orthodontic treatment.~   "
174095|NCT01286285|"~     The purpose of the study is to assess the number of severe, laboratory-confirmed influenza in~     children hospitalized to paediatric intensive care units. Furthermore, the proportion of~     these children from all children hospitalized to paediatric intensive care units with acute~     respiratory infections will be established.~   "
174096|NCT01286272|"~     This randomized phase II trial studies how well ofatumumab and bendamustine hydrochloride~     with or without bortezomib works in treating patients with untreated follicular non-Hodgkin~     lymphoma. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different~     ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. It~     is not yet known whether ofatumumab and bendamustine hydrochloride are more effective with~     bortezomib in treating patients with follicular non-Hodgkin lymphoma.~   "
174097|NCT01286259|"~     The purpose of this study is to determine whether a two-week course of disulfiram will reduce~     the HIV-1 latent reservoir in patients on highly active antiretroviral therapy (HAART).~   "
174098|NCT01286246|"~     Prematurity remains the most important single factor in perinatal morbidity and mortality.~     Unfortunately, the rate of premature delivery is increasing in Canada and is especially high~     in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of~     research into the causes of spontaneous preterm labor, few effective treatments have been~     identified. Progesterone is one candidate treatment. The purpose of this study is to~     investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm~     labor.~      Pregnant women who have symptoms of premature labor will be invited to take part in the study~     if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be~     randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks,~     or to take a placebo preparation. Neither the women nor their clinician will know which group~     they are in.~      Women and their babies will be followed until 28 days after the birth, to find out about the~     length of the pregnancy, any adverse events that might occur (none have been reported in~     previous trials), and to look at whether women have taken the treatment.~      When the study is complete, the results for the progesterone group will be compared to the~     placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then~     this will be a possible treatment to help mothers in the future.~   "
174099|NCT01286233|"~     RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     fatigue.~      PURPOSE: This research study is studying biomarkers associated with fatigue in patients with~     early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.~   "
174100|NCT01286220|"~     The purpose of this study is to determine if twice weekly 10 minute dilute bleach baths~     decreases disease severity in patients with moderate to severe atopic dermatitis.~   "
174101|NCT01286207|"~     This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949);~     MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the~     long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and~     migraine recurrence.~   "
174102|NCT01286194|"~     This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where~     the principal investigator will be a pharmacist.~   "
174103|NCT01286181|"~     Although drug therapies and pulmonary rehabilitation have greatly improved COPD symptoms, as~     many as 50% of patients with severe COPD have inadequately controlled dyspnea. Device-guided~     breathing is a behavioral intervention that guides respiratory rates into a therapeutic~     range; prolongation of the expiratory phase improves hyperinflation, the most significant~     driver of dyspnea in this population. Device-guided breathing, has no known side-effects, and~     may represent a cost effective adjunctive treatment for dyspnea in severe COPD.~   "
174104|NCT01286168|"~     Surgical site infection (SSI) after breast and axillary surgery occurs more often than for~     other clean surgical procedures. Infection in the setting of a tissue expander can be~     devastating and can lead to early implant loss and failed reconstruction. Surgical drains~     have been noted as a potential source for surgical site infections. Hypothesis: Bacteria~     present in surgical drains after tissue expander reconstruction may be decreased by simple~     and inexpensive local antiseptic interventions.~   "
174105|NCT01286155|"~     To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's~     esophagus (BE) in the community.~      To develop a population based clinical risk factor prediction model for the diagnosis of BE~     and identify novel risk factors for BE which would make population based screening more~     efficient. This will be an important first step in identifying the target population for BE~     screening, another crucial component of making screening feasible and efficient~   "
174106|NCT01286142|"~     In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A~     (H1N1). Although little is known about the pandemic influenza strain in children, during~     previous pandemics and influenza seasons children less than one year of age were shown to be~     at higher risk of influenza complications than older children. In light of the 2009 H1N1~     pandemic situation, the U.S. Food and Drug Administration (FDA), European Medicines Agency~     (EMA), and Health Canada issued emergency authorizations for oseltamivir to be used to treat~     and prevent influenza in infants under 1 year of age. It is anticipated that oseltamivir use~     in infants will dramatically increase due to the new authorizations for use in this~     population and high prevalence of H1N1 influenza circulating in the population. Ongoing~     safety surveillance is critical and this study will provide further data for evaluating the~     risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of~     both seasonal and pandemic influenza viruses circulating in the population. The study will~     also provide useful information on the dose and duration of treatment used in clinical~     practice and their relationship to adverse events.~   "
174107|NCT01286129|"~     Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of~     rhinitis, and multiple challenges may more adequately approximate natural exposure.~      Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory~     parameters in rhinitics with or without asthma.~   "
174108|NCT01286116|"~     The primary objective is to assess the safety of the CardioKinetix Parachute Implant and~     Delivery System in the partitioning of the left ventricle in patients with heart failure due~     to ischemic heart disease.~   "
174109|NCT01286103|"~     The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in~     the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen~     in healthy adult volunteers~   "
174110|NCT01286090|"~     The purpose of this study is to assess the effectiveness of cisapride at improving symptoms~     associated with gastroparesis (a stomach disorder) in patients with diabetes mellitus.~   "
174111|NCT01286077|"~     The purpose of this study is to assess the effect of bortezomib on myeloma-related bone~     disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who~     have received high dose chemotherapy and autologous stem cell transplantation for primary~     treatment of MMY (single- or double-transplant). Eligible patients will be randomized (study~     treatment assigned by chance like flipping a coin) to either bortezomib or observation alone.~     Patients in the bortezomib arm will receive treatment of bortezomib for a total of 4 cycles.~     All subjects will be followed for a total of 24 months after randomization.~   "
174112|NCT01286064|"~     The aim of the present prospective study was to investigate the fluorescence emission of~     human blood plasma of patients with colorectal cancer.~      For years, serum tumor markers have been studied for the diagnosis and follow-up of~     colorectal cancer, among which carcinoembryonic antigen (CEA) has achieved promising results.~     However, the sensitivity of CEA for colorectal cancer is less than 25% and elevated CEA~     levels also occur in patients with benign disease, as well as in patients with other~     carcinomas. Nevertheless, surveillance programs are often based on the CEA test and~     combination with other markers is at present a matter of research. Alternative methods based~     on optical fluoroscopy have been introduced in experimental stages for clinical diagnosis of~     cancer. Few studies have been reported on the application of native fluorescence spectroscopy~     of biofluids in the diagnosis of tumoral diseases. The above reported findings prompted us to~     investigate the fluorescence emission of human blood plasma of patients with colorectal~     cancer. For this purpose, the blood of patients was collected and the fluorescence~     Preliminary measurements on plasma of patients bearing colon cancer showed that the~     fluorescence spectra were mainly characterized by the presence of an emission peaking at~     620-630 nm, whose excitation spectrum peaked at 405 nm. Hence, an excitation wavelength of~     405 nm was selected for the study. The fluorescence emission spectra were recorded in the~     range of 430-700 nm.~   "
174113|NCT01286051|"~     Ovulation induction (OI) using gonadotropins is one of the most widely prescribed treatments~     of infertility. One common problem encountered while attempting OI using gonadotropins is~     premature ovulation. The purpose of this study is to examine the effect of a single injection~     of a medication, called ganirelix, to prevent premature ovulation. Patients will be divided~     into two groups. In the first group, gonadotropins will be used to stimulate the ovaries. In~     the second group gonadotropins will be used in addition to a single injection of ganirelix, a~     gonadotropin releasing hormone (GnRH) antagonist. Pregnancy rates will be compared between~     groups.~   "
174114|NCT01286038|"~     The purpose of this study is to evaluate the safety and efficacy of eltrombopag in people who~     have myelodysplastic syndrome (MDS) with thrombocytopenia who have progressed or are~     resistant to decitabine or azacitidine. (These are the only 2 drugs approved by the U.S. Food~     and Drug Administration [FDA] which can improve platelet counts). The investigators (the~     study doctor, study staff, and sponsor) want to find out what effects, good or bad,~     eltrombopag (study drug) may have on people with low platelet counts due to MDS. The~     investigators will also be testing how well eltrombopag may work at different doses in these~     diseases.~   "
174115|NCT01286025|"~     This study is designed to examine how the type of learning case affects the thinking of~     medical students in tutorial~   "
174116|NCT01286012|"~     The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing~     the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb)~     levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who~     receive conventional dialysate without iron.~   "
174117|NCT01285999|"~     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™~     Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single~     de novo atherosclerotic coronary artery lesion.~   "
174118|NCT01285986|"~     Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to~     PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia~     with respect to primary patency, secondary patency, and limb salvage~   "
174119|NCT01285973|"~     The aim of this prospective study is to assess the utility of treatment of leg ulcers using a~     skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous~     oxygen pressure in the distal region of the wound.~      This is a multi-centre study on 60 patients who have a lower limb ulcer.~   "
174120|NCT01285960|"~     The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF~     V2 System when treating symptomatic uterine fibroids.~      The ExAblate System is a medical device that involves a focused ultrasound system and an MRI~     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the~     targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each~     sonication is used to heat small spots in the fibroid much like a magnifying glass can be~     used to focus light to heat a spot. The heat created kills a portion of the fibroid with the~     goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are~     performed until the entire fibroid is treated or the treated volume is determined to be~     appropriate.~      The ExAblate system is commercially approved in the United States to treat symptomatic~     uterine fibroids.~      The ExAblate UF V2 System is an experimental device and is being investigated in this study.~     While similar to the commercial system, the ExAblate UF V2 device includes the following~     major changes, among others, which are intended to improve device performance and safety:~        -  Up and down movement of the ultrasound transducer, in an attempt to improve fibroid~          treatment by moving the ultrasound focal point within the targeted fibroid.~        -  Ultrasound energy can be turned off for a specific area in an attempt to minimize amount~          of energy passing through sensitive areas of the body.~   "
174121|NCT01285947|"~     The purpose of this study is to compare the pain experience of patients who have not had~     dermatologic procedures (previously unexposed) using energy devices (lasers,~     radiofrequency, ultrasound, etc.) with patients who have previously had procedures~     (previously exposed) using energy devices. Based on previous clinical encounters,~     individuals with no prior experience with cosmetic procedures appear to experience more pain.~     However, no study to date has thoroughly examined this observation. As a result, this study~     has been designed to find a possible difference in pain perception between previously exposed~     and unexposed patients undergoing cosmetic procedures using energy devices.~   "
174122|NCT01285934|"~     Type 1 diabetes mellitus (T1D) results from immune-mediated destruction of insulin-producing~     islet cells. The loss of islet cells is traditionally treated with insulin therapy and in~     some cases pancreas or islet cell transplantation. Another approach would be to preserve~     islet cell mass before it is irreversibly lost. Previous trials using immune suppression~     within 6 weeks of T1D onset have demonstrated diminished exogenous insulin requirements~     compared to untreated controls. In our prior phase I non-randomized study, by extending~     immune suppression to the point of immune ablation / immune reset with autologous HSC~     support, several patients with new onset T1D have maintained an insulin-free, drug free~     remissions for more than 4 years. Although these results appear highly promising, it may be~     argued that our results are mitigated by the documented honeymoon effect following T1D, that~     is by a normal transient insulin free interval occurring after disease onset in some~     patients. The goal of this trial is to extend this phase I study of new onset T1D to clarify~     whether our post transplant insulin free interval is due to treatment intervention~     (transplant) or a result of a normally occurring insulin free honeymoon period. Both groups~     will receive identical change of life style (i.e. diet, exercise) education.~   "
174123|NCT01285921|"~     Vestibular signals deeply influence hippocampal spatial representations and may contribute to~     the navigational deficits of humans with vestibular dysfunction. The reciprocal influence of~     hippocampal signals on the vestibular system are more putative. The investigators wish to~     investigate in this pilot study the consequences on vestibular system of the removal of the~     hippocampal formation to treat drug resistant temporal lobe epilepsy.~   "
174124|NCT01285908|"~     Background:~      - Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex~     action of the automatic nervous system makes blood vessels tighten when people stand up. The~     nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps~     blood pressure in check. In orthostatic hypotension, the nervous system does not release~     enough norepinephrine when a person stands up, which can cause fainting or falling.~     Researchers are interested in determining whether norepinephrine given as a drug by vein can~     help maintain blood pressure during changes in body position.~      Objectives:~      - To determine whether intravenous norepinephrine can maintain blood pressure in people with~     orthostatic hypotension.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with orthostatic hypotension~     related to Parkinson's disease or pure autonomic failure.~      Design:~        -  This study will require a 2-day inpatient admission to the NIH Clinical Center. The~          first day will involve laboratory evaluation and the second day will involve testing~          with norepinephrine. The second day requires an overnight stay.~        -  Participants will be screened with a medical history and physical examination, blood~          samples, and an electrocardiogram or echocardiogram.~        -  Participants who are on medications may be asked to taper or discontinue one or more~          medications for the purposes of this study. Participants may not take aspirin or any~          drugs that slow blood clotting for 7 days before study participation.~        -  Day 1: Participants will have a clear liquid breakfast, and will have a 1-hour baseline~          tilt table test to monitor blood flow, skin temperature, sweating, and blood pressure.~          Body temperature and breathing will also be monitored.~        -  Day 2: Participants will have a clear liquid breakfast, and will have a 2-hour tilt~          table test. Initial blood pressure readings will be taken, and an intravenous line will~          be placed. Participants will then receive norepinephrine or saline, followed by~          additional position changes of the tilt table to measure blood pressure differences~          before returning to the starting position. After about 10 minutes, the tilt table~          testing and infusion will be repeated with the other drug (saline or norepinephrine).~        -  Participants will be discharged 24 hours after the testing is complete.~   "
174125|NCT01285895|"~     Main objective : This project aims to assess the educational needs of patients who received a~     lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis.~      Specific objectives : Evaluate the specific needs dependent on seniority transplantation : 3~     to 6 months, 6 months to 2 years, more than 2 years after transplantation~      Secondary objectives :~        -  Assess the state of health~        -  Assess the knowledge~        -  Assess gestural know-how~        -  Assess the cognitive know-how~        -  Assess the behaviour adopted in reality by the patient~        -  Assess motivation psychosocial factors of :~             -  self-efficacy and inefficiency~             -  representation of obstacles, disadvantages of treatment~             -  sense of control over their health~             -  feeling of being supported by health professionals, by his close~             -  representation of his responsibility to take care of his health, to follow his~               treatment, to be active about his treatment~   "
174149|NCT01285583|"~     The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to~     riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the~     preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.~   "
174150|NCT01285570|"~     Post-operative administration of ulimorelin is expected to reduce time to recovery of~     Gastrointestinal (GI) function in patients who have undergone partial large bowel resection.~   "
174151|NCT01285557|"~     The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin~     compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and~     esophagogastric junction cancer previously untreated with chemotherapy.~   "
174126|NCT01285882|"~     Main objective : This project aims to have a better understanding of the influence of~     representations of patients with mucoviscidosis, their assistants and their medical persons~     in the choice of patients to accept or not lung transplantation.~      Specific objectives :~        1. Identify the knowledge, representations, or feelings of patients which could constitute~          bridles or factors of motivation to use for transplantation.~        2. Identify the knowledge, representations, or feelings of medical persons which could~          constitute bridles or factors of motivation to the encouraging proposal to patients of~          lung transplant.~        3. Identify the knowledge, representations, or feelings of assistants which could~          constitute bridles or factors of motivation to the encouragement of lung~          transplantation at its close.~        4. Identify the needs of patients, assistants and medical persons to successfully reduce~          these bridles to transplantation and increase the factors of motivation.~        5. Compare the representations of patients, assistants and medical persons~        6. Search representations associated with patients who refuse the transplantation and those~          who accept the transplantation~   "
174127|NCT01285869|"~     The hypothesis of this study is that long-term outcome in elderly patients admitted with the~     diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP)~     would improve with a multidimensional intervention including assessment of co-morbidities,~     nutritional, functional and cognitive status and immunization.~   "
174128|NCT01285856|"~     Justification and aims of the study: The principal aim of use of opiate substitutes such as~     methadone or high-dose buprenorphine (HDB) is to reduce the need or the desire to consume the~     opiate to which the patient is addicted. Adjustment of the initial dose and regular~     re-evaluation of the efficacy of treatment are key elements in the success of such~     management. While too high a dose can be responsible for side effects leading to abandonment~     of treatment, too low a dose can induce the reappearance or even the reinforcing of parallel~     consumption of other psychoactive substances, in particular cocaine, alcohol and cannabis.~     The principal aim of this project is to determine the course of parallel consumption in~     patients who have been receiving a maintenance dose of methadone or HDB for at least two~     months, by analysis of a sample of hair, a biological matrix which is innovative for this~     type of study. Hair testing establishes a retrospective profile of consumption. The secondary~     aims of this project are (i) to validate the French versions of Handelsman's subjective and~     objective opiate withdrawal scales and to seek a possible correlation between high scores on~     these scales and the presence of parallel consumption, and (ii) to seek an association~     between polyconsumption and common functional polymorphisms of metabolic enzymes of methadone~     and HDB.~      Expected results: Hair testing, which has the particular advantage of a long detection window~     so that samples need only be taken at intervals, could improve the biological monitoring of~     patients on substitutive treatment.~      Validation of the French version of Handelsman's scales of objective and subjective signs of~     opiate withdrawal and search for any correlation with parallel consumption will enable these~     scales to be used in daily practice for clinical surveillance of patients on substitutive~     treatment.~      If a polymorphism of a metabolic enzyme of one or other of these molecules is detected, rapid~     genotyping of a simple saliva sample will be valuable in guiding the choice of medication~     when deciding on a treatment strategy~   "
174129|NCT01285843|"~     This is a monocentric, prospective, randomized clinical survey to verify if the~     periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component~     is equivalent.~   "
174130|NCT01285830|"~     An altered microbial exposure may be partly responsible for the increase of allergic diseases~     in populations with a western lifestyle. Activation of the immune system by microbes early in~     life is probably required for an accurate maturation of the immune system. Probiotics, live~     bacteria which are considered to confer health when ingested, have been suggested to prevent~     eczema and sensitisation infants.~      The aim of this study is to assess the effect of oral supplementation with the probiotic~     bacterium Lactobacillus reuteri in infancy on the development of allergic disease and~     sensitisation during the first 2 years of life and to examine mechanisms possibly underlying~     eventual effects on allergic manifestations.~      A follow up was performed at 7 years of age.~   "
174131|NCT01285817|"~     To establish the anti-tumour effect of this metronomic combination regimen defined by~     progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of~     treatment, as well as response rate after any number of cycles of treatment (best~     response).~      To define the safety profile of the combination. To characterize pharmacodynamics of the drug~     combination with the use of angiogenic markers (CEP, CEC, microparticles).~   "
174132|NCT01285804|"~     The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT)~     on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or~     adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will~     eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the~     oxygen concentration in the oropharynx.~   "
174133|NCT01285791|"~     Excess visceral fat is a key factor in the development of metabolic syndrome associated with~     obesity. After bariatric surgery, patients experience weight loss accompanied by a decrease~     in the amount of total body fat. It is unclear how the different surgical procedures vary in~     their effect on the visceral and subcutaneous fat change. Ultrasonography (US) is an~     effective, efficient method in assessing this metabolically active layer of fat even when~     compared with gold standard techniques such as computed tomography and magnetic resonance~     imaging. Only a few studies managed to show the actual decrease in the visceral fat layer~     after these kinds of surgeries. The aim is to compare by ultrasound evaluation the extent of~     fat layers reduction after laparoscopic adjustable gastric banding (LAGB), laparoscopic~     sleeve gastrectomy (LSG) and laparoscopic roux-en-y gastric bypass (LRYGB). The hypothesis is~     that the sleeve gastrectomy and gastric bypass being not only a restrictive procedure but~     also a malabsorptive procedure will have the best results in decreasing the amount of~     visceral fat.~   "
174134|NCT01285778|"~     Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC.~     Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical~     activity in a single report of a refractory anal canal SCC patient. Based on this background,~     we propose to conduct a phase II study to investigate the efficacy and toxicity of~     radiotherapy with the association:~        -  5-FU 1000mg/m2 on days 1-4 and 29-32~        -  Mitomycin C 10mg/m2 on days 1 and 29~        -  Panitumumab 6 mg/kg on day 1, then every 2 weeks for 8 weeks~   "
174152|NCT01285544|"~     There will be no significant differences in the efficacy and tolerability between the test~     and reference formulations of atorvastatin 20 mg in these Korean adults with primary~     hypercholesterolemia.~   "
174226|NCT01284569|"~     The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the~     receptor for interleukin 6 (IL6R), is safe and effective after single or multiple~     administrations to patients with rheumatoid arthritis (RA). Patients will receive different~     single or multiple doses of either placebo or ALX-0061.~   "
174135|NCT01285765|"~     In this study, the investigators purpose is to evaluate the adaptation of treatment with~     early response based on PET scan results after 2 cycles of chemotherapy, for patient aged~     from 18 to 80 years, with low IPI DLBCL.~      This is an open randomized study.~      The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non~     inferiority of the experimental arm in comparison to standard arm:~      In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account~     of PET scan results after 2 cycles.~      In experimental arm, early good responder patients (defined as having a negative PET scan~     after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.~      In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam~     is needed to confirm the failure and an intensive chemotherapy is then recommended.~      All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan~     will be reviewed by a group of expert according to Deauville criteria defined by Meignan et~     al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for~     all patients. The final evaluation of response will be made according to 2007 Cheson's~     criteria.~   "
174136|NCT01285752|"~     To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.~   "
174137|NCT01285739|"~     The purpose of this study was to determine occurrence of ventilator associated pneumonia~     (VAP) in tracheostomized patients with COPD discharged in invasive mechanical ventilation~     (IMV) compared to patients with CPOPD discharged with tracheostomy but in non invasive~     mechanical ventilation (NIMV).~   "
174138|NCT01285726|"~     The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD)~     patients and its evolution over a period of four years, independent of the PD treatment~     modality (APD or CAPD) and the PD solution type.~   "
174139|NCT01285713|"~     To determine whether the addition of dextrose to IV fluids in the treatment of~     gastroenteritis leads to a decrease in serum ketones. Secondarily, the clinical benefits of~     dextrose containing fluids in the treatment of gastroenteritis will be assessed.~   "
174140|NCT01285700|"~     This is a single-center, open-label, multiple-dose study of the efficacy and long-term safety~     of Lamazym for the treatment of patients with alpha-mannosidosis.~   "
174141|NCT01285687|"~     A randomized, controlled, single-blinded study comparing conventional postoperative analgesia~     with paracetamol-on-demand with the same regime plus acupuncture.~      The hypothesis is that postoperative treatment of children undergoing tonsillectomy with~     acupuncture will reduce pain with minimal unwanted effects.~   "
174142|NCT01285674|"~     In this study we will aim to determine if cisplatin ototoxicity can be prevented by~     intratympanic administration of corticosteroids.~   "
174143|NCT01285661|"~     Prospective cohort study aimed at optimizing the duration of anticoagulant treatment in~     patients at their first episode of proximal deep venous thrombosis (DVT) of the lower~     extremities, whose pathogenesis is either unknown (idiopathic DVT) or associated with minimal~     risk factors for thrombosis, with the help of an algorithm which incorporates both~     ultrasonography and D-dimer information. All patients will be followed-up until 1) the~     achievement of a major end-point; 2) the date of lost to to followup; 3) the date of death;~     4) the date of study stop. The purpose of this study is to demonstrate the safety of~     withholding anticoagulation from a subgroup of patients with proximal DVT whose veins have~     recanalized and present with a repeatedly negative D-dimer (at baseline, after 1 and 3~     months). The approach will be deemed to be safe if the annual rate of recurrent VTE in~     patients who will have their anticoagulation discontinued is lower than 5%.~   "
174144|NCT01285648|"~     The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and~     evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two~     groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive~     Airway Pressure (CPAP) patients.~   "
174145|NCT01285635|"~     This study will examine the effects of an investigational drug called AT-101 in combination~     with an FDA approved cancer drug called Docetaxel. It is hoped that AT-101 will help the~     Docetaxel to have a better effect in slowing or stopping cancer cell growth. This study will~     help the researchers learn what effects, if any, the combination of AT-101 and Docetaxel has~     on your cancer. For instance, will the combination cause your tumor(s) to shrink or stop~     growing? The researchers will also learn about the safety of the combination of AT-101 and~     Docetaxel. For instance, are there any side effects? If so, what kind of side effects does~     the combination cause? How severe are the side effects, and how often do they occur?~   "
174146|NCT01285622|"~     The investigators propose a prospective observational trial. The investigators plan to enroll~     40 female subjects scheduled for elective robotic gynecological surgery under general~     anesthesia. Hemodynamic data will be recorded at the following intervals: after induction of~     anesthesia (Baseline), after initiation of pneumoperitoneum, after positioning the patient in~     Trendelenburg position, and every 15 minutes thereafter. At the end of surgery measurements~     will be recorded after reversal of Trendelenburg position and after deflation of the~     peritoneum.~      Forearm - fingertip temperature gradients will be measured by Mon-a-thermometer (Mallinckrodt~     Medical, Inc. St. Louis, MO) and disposable Mon-a-therm thermocouples. Vasoconstriction will~     be identified when forearm - fingertip temperature gradient is ≥ 00C and PI <1.~      Intra-abdominal pressures will be recorded during each measurement of hemodynamic parameters.~     Trendelenburg position will be measured with an angle ruler.~      The aim of our study is to test the hypothesis that stroke volume will drop significantly~     after initiation of pneumoperitoneum and that it will increase after placement in~     Trendelenburg position in patients undergoing robotic gynecological procedures. Secondly, the~     investigators will test the hypothesis that PVI changes correlate with changes in stroke~     volume and pulse pressure variation (PPV) and can predict an increase in stroke volume after~     a fluid bolus. The third hypothesis is that delta PVI is independent of the vaso-status of~     precapillaries at the measured site.~   "
174147|NCT01285609|"~     The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin~     will extend the lives of patients with squamous only non small cell lung cancer more than~     placebo plus Paclitaxel and Carboplatin.~   "
174148|NCT01285596|"~     Young and elderly, male and female subjects are each given 2 different doses of mirabegron~     for 7 days each. Levels of mirabegron in the blood are assessed.~   "
174153|NCT01285531|"~     Objective: To evaluate pediatric emergency department provider lumbar puncture success with~     and without the Compass Lumbar Puncture Enhanced, a new pressure transducer, in order to~     determine: the proportion of lumbar punctures where a) any cerebrospinal fluid is obtained on~     the first attempt, b) any cerebrospinal fluid is obtained on any attempt, and c) sufficient~     cerebrospinal fluid is obtained for standard tests (culture, chemistries, cell count); the~     time to provider success in obtaining a) a drop of fluid from the needle, and b) opening~     pressure measurement; the proportion of successful lumbar punctures that contain blood; and~     provider satisfaction.~      Background: Lumbar punctures are necessary to diagnose meningitis, neurological diseases and~     some cancers. They are common pediatric emergency department procedures that frequently~     require repeated attempts or are only partially successful, with sufficient blood to limit~     interpretation. Measuring cerebrospinal fluid pressure during lumbar punctures is recommended~     but rarely done, due to limitations of current technology. Liquid column manometry is~     cumbersome, time-consuming and frequently impractical. Existing pressure transduction probes~     that connect via tubing to external monitors are not designed or recommended for lumbar~     punctures. The pressure is displayed on a monitor that is difficult to view during the LP~     procedure and they equilibrate too slowly to keep pace of pressure changes during LPs. The~     Compass Lumbar Puncture Enhanced is a new, inexpensive, disposable, medical device,~     specifically designed for use during LPs, that has the potential to increase lumbar punctures~     success and decrease blood contamination. It attaches to the spinal needle and displays both~     a numeric pressure value and a pressure waveform, allowing physicians to more readily~     identify the cerebrospinal fluid space and measure cerebrospinal fluid pressure. The device~     is small, easy to use, and readily incorporated into standard practice.~      The Compass Lumbar Puncture Enhanced uniquely provides immediate feedback about pressure that~     may allow physicians to more quickly and confidently identify the CSF space, and instantly~     determine cerebrospinal fluid pressure when the space is reached. The investigators believe~     the Compass Lumbar Puncture Enhanced will increase lumbar punctures success and decrease the~     proportion containing blood. It has the potential to become the standard of care and be used~     in every lumbar puncture procedure. This study is expected to demonstrate the clinical~     utility of the Compass Lumbar Puncture Enhanced to the medical community. Increased awareness~     of the Compass Lumbar Puncture Enhanced and a positive demonstration of the viability of the~     technology will help attract either the investment capital or the strategic partnership~     necessary to fully develop the market.~   "
174154|NCT01285518|"~     This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability~     and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.~   "
174155|NCT01285505|"~     This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual~     formulation is the same as that from an existing sublingual formulation.~   "
174156|NCT01285492|"~     This is a 52-week treatment, multi-center, randomized, open label, parallel group study to~     assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237~     ([glycopyrronium bromide]) using tiotropium as an active control in Japanese patients with~     moderate to severe chronic obstructive pulmonary disease (COPD).~   "
174157|NCT01285479|"~     The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis~     (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects~     in the offspring of women exposed to Gilenya before (up to 8 weeks before last menstrual~     period) and during pregnancy in routine clinical practice. The overall aim is to collect and~     evaluate data on maternal, fetal, and infant outcomes and compare it with reference~     populations.~   "
174158|NCT01285466|"~     The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and~     BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.~   "
174159|NCT01285453|"~     This study will assess the tolerability of combination therapy with ASA404 and docetaxel in~     Japanese patients with advanced or recurrent solid tumors.~   "
174160|NCT01285440|"~     The purpose of this study is to show that improvements in the molecular breast imaging (MBI)~     technology will allow reduction of the administered dose of Tc-99m sestamibi while~     maintaining a sensitivity of 90% for tumor detection.~   "
174161|NCT01285427|"~     The purpose of this study is to compare the Invitrogen SeCore(R) sequencing system and~     uTYPE(R) interpretation software to the predicate device Invitrogen SSP UniTray(R) with~     UniMatch(R) interpretation software and show 95% concordance with 90% confidence.~   "
174162|NCT01285414|"~     This, international, multi-center, Phase 2 study of verubulin will be conducted in patients~     with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts.~     Part A is an open-label dose finding study that will determine the safety and tolerability of~     verubulin in combination with standard treatment. Part B is a randomized open-label study~     that will investigate progression-free survival and overall survival of patients receiving~     verubulin, at the dose determined in Part A, in combination with standard treatment versus~     standard treatment alone.~   "
174163|NCT01285401|"~     The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone~     supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated~     with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of~     patients with Multiple Sclerosis have Vitamin D deficiency.~      Rebif® is known to be an effective treatment for slowing down the progression of MS. The~     purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any~     benefit on the progression of MS compared to Rebif® and placebo.~      Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging~     (MRI). The planned study treatment duration for each study participant is 48 weeks, and the~     study consists of a total of 8 visits. Study participants who are already passed Week 48 at~     the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a~     total of 12 visits.~      During the study, the participant will undergo physical examination, neurological~     assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).~   "
174164|NCT01285388|"~     The purpose of this study is to investigate the safety and tolerability of MB12066 after a~     single oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a~     single oral dose.~   "
174165|NCT01285375|"~     The safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin~     complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and highly~     effective in preventing primary graft non-function, delayed graft function and chronic~     dysfunction in pre-clinical kidney transplantation animal models. The hypothesis is that~     addition of CDC to the graft perfusion solution will decrease the incidence of delayed graft~     function in human kidney transplantation subjects.~   "
174188|NCT01285063|"~     The goal of the this study is to create an interdisciplinary program which includes~     intervention in the fields of nutrition, physical activity and behavior in order to treat~     obesity and overweight among kindergarten children and to examine the influence of such~     program on the BMI,BMI%, physical fitness, knowledge and preferences in the said fields among~     the participants.~   "
174189|NCT01285050|"~     The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type~     specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/~     HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications~     (antiretroviral therapy).~   "
174166|NCT01285362|"~     Over the past 30 years, the prevalence of childhood obesity in the United States has tripled~     from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes,~     cardiovascular disease and nonalcoholic fatty liver disease (NAFLD). The liver pathology~     encompasses a range from isolated fatty liver to advanced fibrosis, cirrhosis and end-stage~     liver disease. Weight loss, particularly if gradual, may lead to improvement in liver~     histology. Unfortunately, few patients in the pediatric population are willing to follow~     these recommendations and achieve weight loss. Medical treatment directed specifically at the~     liver disease has only recently been investigated and approved in patients with NAFLD. The~     beneficial effects of fish oil are attributed to its high concentrations of n - 3 fatty~     acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are major regulators~     of pathways that participate in decreased production and break down of triglycerides and~     fatty acids in the liver. We hypothesize that children with obesity related NAFLD will~     normalize elevated liver enzymes, plasma lipid levels, and attenuate insulin resistance with~     supplements of n-3 fatty acids. If this hypothesis is proven true, then fish oil could be~     used to treat NAFLD and to prevent the deterioration of fatty liver into end-stage liver~     disease.~   "
174167|NCT01285349|"~     This randomized controlled trial is designed to address gaps in couple-based HIV prevention~     research by focusing exclusively on HIV negative concordant couples where one or both~     partners are drug-involved. Building on prior couple-based HIV research that resulted in an~     evidence-based HIV prevention model for couples (Connect), intervention components were~     modified to address dyadic drug risk reduction and drug-related unsafe sex and a couple-based~     HIV risk reduction intervention (Connect II) was designed specifically for drug-involved, HIV~     negative concordant heterosexual couples at risk for HIV/STIs. For this RCT, couples are~     recruited primarily through street outreach in drug using locations and randomized into one~     of three arms: (1) couple-based HIV Risk Reduction condition; (2) individual-based HIV Risk~     Reduction, which delivered the same content as the couple-based condition but was provided to~     either the male or female drug-using partner alone; or (3) couple-based Wellness Promotion,~     which served as an attentional control arm. This RCT tests two major hypotheses: (1) whether~     the HIV risk reduction intervention provided to the couple or an individual partner would be~     more efficacious in decreasing number of unprotected acts of intercourse and having a lower~     cumulative incidence of biologically confirmed STIs over the 12-month follow-up period~     compared to the Wellness promotion control arm and (2) whether the couple-based HIV risk~     reduction intervention would be more likely to decrease the number of unprotected acts and~     have a lower cumulative STI incidence compared to the Individual HIV Risk reduction Arm.~   "
174168|NCT01285336|"~     This study is valuable for the understanding the role of DNA repair system plays in the~     progression of rheumatoid arthritis and for the development of new therapeutic modality in~     the future.~   "
174169|NCT01285323|"~     The primary objective of this study is to determine whether reslizumab is more effective than~     placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with~     eosinophilic asthma.~   "
174170|NCT01285310|"~     The purpose of this study is to determine whether Apremilast is safe and effective in the~     treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms~     of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in~     treated patients who have had an inadequate response to Methotrexate.~   "
174171|NCT01285297|"~     The purpose of this study is to determine the safety of injecting autologous bone marrow~     concentrate with laser transmyocardial revascularization (TMR) for treatment of angina which~     cannot be treated by direct coronary intervention.~   "
174172|NCT01285284|"~     This study will evaluate the efficacy of music (a very well selected list of songs)on~     improving the tolerance to the colonoscopy. The patients will be randomly assigned to receive~     music or not. The authors hypothesis is that music is able to improve the tolerance to~     colonoscopy evaluated as a reduction on the level of anxiety, on the intensity of pain~     experimented during the procedure and a reduction of the administered dose of midazolam~     during the colonoscopy.~   "
174173|NCT01285271|"~     The aim of this study is to determine whether xenon - as compared to sevoflurane - can be~     applied safely in patients for general anesthesia before and after CABG implantation.~   "
174174|NCT01285258|"~     The purpose of this study is to determine the effects of peripartum hysterectomy for maternal~     hemorrhage.~   "
174175|NCT01285245|"~     The purpose of this study is to test whether anakinra is able to reduce insulin resistance.~      This will be tested in overweighted type I diabetes mellitus patients, which have no residual~     beta-cell function. By using this patient group, all positive effects on glycemic control~     should be the consequence of improved insulin sensitivity.~   "
174176|NCT01285232|"~     Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic~     approaches that prevent of delay loss of β-cell function are needed in the treatment of type~     2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the~     progressive β-cell dysfunction in type 2 diabetes mellitus.~      Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra)~     improves beta-cell function in subjects with β-cell dysfunction.~   "
174177|NCT01285219|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and delay the schedule of chemotherapy. Preventive filgrastim~     administration has long been established as the standard of care. A pegylated filgrastim was~     independently developed by GeneLeuk Biopharmaceutical Co., Ltd, Shandong, China. It composed~     of filgrastim and a 20 kd polyethylene glycol molecule covalently bound at the N-terminal~     residue. Preclinical studies phase 1 and phase 2 trials have shown that pegylated filgrastim~     has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare~     with ﬁlgrastim. These characters were similar to those of Neulasta.~      The investigators designed a multicenter, randomized, cross-over phase Ⅲ trial to compare the~     efficacy and safety of a single injection of pegylated filgrastim and daily injections of~     ﬁlgrastim in chemotherapy naive patients receiving commonly used regimens. The hypothesis is~     that pegylated filgrastim is similarly effective and safe with regular filgrastim.~   "
174634|NCT01279226|"~     The purpose of this pilot research study is to collect information on the safety and~     effectiveness of an experimental device intended to be used to improve the appearance of the~     skin by reducing the visibility of wrinkles and by reducing the looseness of skin.~   "
174178|NCT01285206|"~     Patients whose temperature drops below 36.0 degrees Centigrade during or after surgery suffer~     more complications, such as wound infections and increased blood loss, resulting in more~     blood transfusions and longer hospital stays than those who don't.~      There is evidence that even a drop below 36.5 degrees Centigrade is sufficient to cause~     significant adverse effects. Although there is much evidence regarding the effectiveness of~     warming for long operations, there is nothing looking at short procedures such as those~     undertaken in the daysurgery setting.~      A new carbon polymer blanket (HotDog Augustine Biomedical and Design) has been shown, in~     volunteer studies, to be as effective as forced air warming blankets (which are used for long~     operations) in preventing hypothermia. In contrast to forced air, the carbon polymer is~     reusable and has lower running−costs so is likely to be cheaper in the long term. This is~     particularly relevant in the day surgery setting where high numbers of patients are operated~     on. Additionally, and unlike the forced air warmers, the blanket can run on a battery so it~     can be applied from the moment the patient goes to sleep to the moment they wake up so it~     could actually prove more effective at preventing hypothermia in the clinical setting. This~     study aims to determine whether the carbon polymer blankets can reduce the incidence of~     hypothermia in the day surgery (ie. short operating time) setting.~   "
174179|NCT01285193|"~     The purpose of this study is to determine if blood pressure can be reduced in hypertensive~     subjects by regularising and slowing their breathing. This may be a safe and affordable~     complementary treatment for hypertension.~   "
174180|NCT01285180|"~     Daxas (roflumilast) is the first oral anti-inflammatory phosphodiesterase inhibitor (PDE-4)~     for patients with severe chronic obstructive pulmonary disease (COPD) experiencing chronic~     cough and sputum and with a history of exacerbations as add-on to bronchodilator treatment.~     With its mode of action Daxas can reduce exacerbations rates and improve lung function~     parameters which may result in a better health-related quality of life and an improved~     long-term management of COPD.~      The aim of this non-interventional study is to evaluate data on quality of life in COPD~     patients in Germany in a real life medical setting. Evaluation is based on two COPD specific~     questionnaires to assess the patient`s health status over six months. During the study,~     socio-demographic data and cost-of-illness data will be recorded. Daxas (tablet) will be~     administered once daily. The study will provide further data on the safety and tolerability~     of Daxas.~   "
174181|NCT01285167|"~     Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible lung~     disease characterized by chronic bronchitis and/or emphysema, resulting in breathlessness,~     cough and sputum. As COPD progresses, patients experience increasing deterioration of their~     health-related quality of life, with greater impairment in their ability to work and~     declining participation in social and physical activities.~      The aim of this non-interventional study is to evaluate data on quality of life in COPD~     patients in Germany in a real life medical setting under therapy with the~     phosphodiesterase-inhibitor (PDE-4) roflumilast (Daxas). Evaluation is based on two COPD~     specific questionnaires to assess the patient`s health status over six months. During the~     study, lung function measurements such as spirometry will be conducted according to common~     medical standard. Daxas (tablet) will be administered once daily. The study will provide~     further data on the safety and tolerability of Daxas.~   "
174182|NCT01285154|"~     Steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young~     adults with three incisions to increase the coverage; however the amount of correction~     remained questionable due to ligamentous attachments that hinder the rotation. The~     investigators modified the technique with two anterior incisions and ramus cuts close to~     inferior acetabulum. The purpose of this study is to compare these two techniques in femoral~     head coverage~   "
174183|NCT01285141|"~     A vaccine to prevent infection with the Human Immunodeficiency Virus (HIV) is urgently~     needed. Worldwide, most HIV infections occur through sex between a man and woman. The vaccine~     in this study consists of a protein from HIV that has been synthetically produced and linked~     to a protein that boosts immune responses. It has not been tested in humans before, but it is~     expected (from animal studies) that direct application into the female genital tract (via the~     vagina) as liquid drops, will provoke immune protection at the site of HIV infection. This is~     less applicable to men, therefore only healthy, HIV negative women will be recruited. The~     investigators will recruit at one site, which is a university vaccine research centre with~     experience of running similar trials. The study will last 24 weeks during which subjects will~     have blood samples taken on six visits, and three immunisations over 12 weeks in which 1~     millilitres of vaccine is placed into the vaginal by inserting a small plastic syringe. The~     purpose of this initial small study is to monitor safety of the vaccine and to determine~     whether it is appropriate to continue into future, larger studies in which the immune~     response to the vaccine is measured.~   "
174184|NCT01285115|"~     In this randomized, double blinded, Parallel-controlled study, the investigators planned to~     give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of~     generalized anxiety disorder according to dosage form.~   "
174185|NCT01285102|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells or stopping them from~     dividing. Chemoembolization kills tumor cells by blocking blood flow to the tumor and keeping~     chemotherapy drugs near the tumor.~      PURPOSE: This phase II trial is studying how well chemoembolization using irinotecan works in~     treating patients with liver metastases from metastatic colon or rectal cancer.~   "
174186|NCT01285089|"~     This study is conducted in Europe. The aim of this prospective, observational study are to~     describe the different clinical practice and detailed haemostatic management of activated~     recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France.~     The secondary aim is to assess the primary haemostasis disorder associated with the~     coagulation disorders, if available.~   "
174187|NCT01285076|"~     This is a multi-center, observational, retrospective and cross-sectional study to be~     conducted in a cohort of consecutively selected participants with Type 2 diabetes mellitus~     (DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF)~     combination therapy by their cardiologist, nephrologist, neurologist, or family practice~     doctor for at least 6 months prior to Study Enrollment.~   "
178544|NCT01228006|"~     It is hoped that the group treated with Panax Ginseng, Vitamins and Minerals obtain~     significant reduction in levels of stress and fatigue and that the results are superior to~     the placebo group.~   "
174190|NCT01285037|"~     Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to~     participants with advanced cancer and to determine any side effects that may be associated~     with LY2801653 in this participant population. Efficacy measures will be used to assess the~     activity of LY2801653.~      Part B- The dose determined in Part A will be used along with efficacy measures to assess the~     activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and~     neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and~     cholangiocarcinoma.~      Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that~     may be safely given to participants with HNSCC when taken with standard doses of cetuximab~     Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that~     may be safely given to participants with cholangiocarcinoma when taken with a standard dose~     of cisplatin.~      Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653 that~     may be safely given to participants with cholangiocarcinoma when taken with gemcitabine plus~     cisplatin.~      Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653 that~     may be safely given to participants with gastric cancer when taken with ramucirumab.~   "
174191|NCT01285024|"~     This is a prospective, randomized, controlled, single-center study to assess the~     effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty~     (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects.~     Vitagel will be used in a randomly selected cohort of fifty-five patients undergoing primary~     unilateral THA procedures; a control group of fifty-five patients will not receive Vitagel or~     any other hemostatic agent except those that are standard during a primary THA. The study~     will evaluate the effectiveness of Vitagel in reducing intra- and post-operative bleeding.~   "
174192|NCT01285011|"~     Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the~     most frequently affected, but the other small toes may also be involved. When nonoperative~     treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the~     Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs:~        -  Internal fixation;~        -  Interphalangeal Compression;~        -  Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for this~          specific arthrodesis. The objective of this study is to evaluate the efficacy and safety~          of the Proximal Interphalangeal Implant: Ipp-On at short term follow up.~      The safety of the Ipp-On will be described in terms of rate of device related complications.~      The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.~   "
174193|NCT01284998|"~     In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may~     be more indicated than the distal osteotomy as it allows to achieve a greater degree of~     correction.~      However, weight bearing forces on the head of the first metatarsal acting at a distance from~     the osteotomy site subject the construct to an important dorsiflexion stress. Fixation~     strength being the important consideration led to design the B-BOP® Lock plate, specifically~     dedicated to basal osteotomy of the first metatarsal, with the following characteristics:~        -  plantar positioning to obtain the best stability and resistance while reducing the~          implant bulkiness;~        -  anatomical shape adapted to the plantar curve of the first metatarsal. Taking advantages~          of the most appropriated anatomical site to implant the B-BOP® Lock plate directly on~          tension, it offers an innovative and unique basal osteotomy fixation solution.~      The B-BOP® Lock osteosynthesis plate benefits now of the Surfix locking screws technology.~      The purpose of this study is to collect and publish data from several centers, several users.~   "
174194|NCT01284985|"~     The great toe is vital for normal, pain free ambulation. Decreased function associated with~     osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis~     or Hallux Limitus leading to a painful great toe. Patients experience pain during ambulation~     especially during the push-off phase of gait. When surgery is indicated four techniques are~     used for hallux rigidis; cheilectomie, resection arthroplasty, arthrodesis and implant~     surgery (1). Endoprostetic implants are relatively new. Silicone Implants like the~     arthroplasty developed by Swanson (2) resulted in foreign body reactions and periarticular~     bone loss. Subsequent implants, in particular the metallic hemi arthroplasty with or without~     polyethylene articulations, have been more successful (3). Still, implants are prone to wear~     of the material and show higher rates of loosening and infection compared to other techniques~     (4;5). In the last decades several new implants are described using two non cemented pressfit~     components, of titanium alloy or ceramic (6-9). Between 2001 and 2004 the investigators~     developed a new concept with instrumentation for exact alignment to prevent for wear with~     loosening of the implant on the long term. The implant has bone-conserving characteristics to~     enable arthrodesis as a salvage procedure. It is a completely modular two-component press fit~     titanium alloy implant with polyethylene insert that can be used as either for hemi-, total-~     or revision arthroplasty.~      The purpose of this study is to have an overview of clinical status of the patient implanted~     with the METIS® prosthesis at short term (2 years of follow-up). The objective of this study~     is to evaluate the safety and efficacy of the Metatarso-Phalangeal prosthesis METIS® at short~     term follow up.~   "
174195|NCT01284972|"~     The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that~     consists of a flat tibial component, an anatomically-shaped talar component, and a~     high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt~     to address the needs of minimal bone resection, extended bone support, proper ligament~     balancing, and minimal contact stressed within and around the prosthesis.~      The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total~     Ankle prosthesis at short and mid term follow up.~   "
174196|NCT01284959|"~     The main objective of this study was to assess subjective experiences related to secondary~     negative symptoms and cognitive performance in healthy volunteers in response to multiple~     doses of paliperidone ER and risperidone in a double-blind, placebo-controlled trial. Adverse~     events caused by these drugs were also evaluated.~   "
174227|NCT01284556|"~     Primary:~      - to evaluate the efficacy of phenobarbital in reducing seizure frequency.~      Secondary:~        -  to confirm dose response relationship,~        -  to assess the effects on Type I seizures,~        -  to assess the safety of phenobarbital~        -  to assess the drug tolerability.~   "
174197|NCT01284946|"~     While clinical phlebotomy is current standard practice for alleviating non-transfusion iron~     overload in patients with PCT, it may not be suitable for all patients. For example, some~     patients are unwilling to be adequately phlebotomized because of inconvenience, as phlebotomy~     can be cumbersome, especially during the induction treatment phase requiring frequent clinic~     visits (twice a month, for at least 6 months) or because of venous access difficulties. Other~     patients are unable to undergo phlebotomy due to medical reasons such as anemia or~     cardiopulmonary disorders. It is postulated such patients with PCT who have non-transfusion~     iron overload could benefit from treatment with deferasirox (Exjade®), a once daily oral iron~     chelator licensed in several countries, including the EU, for treating transfusion iron~     overload in adult and pediatric patients. Although there is some data on the efficacy and~     safety of deferasirox in patients with HH, who, like those with PCT, have non-transfusional~     iron overload, there is a need to evaluate the safety and efficacy of deferasirox treatment~     of non-transfusion iron overload in patients with PCT.~   "
174198|NCT01284933|"~     The purpose of this study is to determine the frequency, characteristics, and consequences of~     vulnerable carotid artery plaques ipsilateral to an acute ischemic stroke or TIA in the~     territory of the internal carotid artery.~   "
174199|NCT01284920|"~     This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after~     oral administration to patients with castration-resistant prostate cancer.~   "
174200|NCT01284907|"~     The purpose of this study is to determine whether vitamin D supplements can improve asthma~     control in children with moderate to severe asthma~   "
174201|NCT01284894|"~     Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy,~     patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is~     the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two~     different techniques are available: the conventional manometry and the high resolution~     manometry. The second one may improve the diagnostic yield and the tolerance of examination~     in patients with dysphagia.~   "
174202|NCT01284881|"~     Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a~     treatment option for sleep-disordered breathing (SDB).~      The purpose of this study is to compare active measurement of MRA compliance with patient's~     self-report.~   "
174203|NCT01284868|"~     To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will~     be given a beta-blocker at the same time as mirabegron.~   "
174204|NCT01284855|"~     This study aims at comparing two doses of antivenom in the treatment of snake bite~     envenoming. It will take place in 3 centers in rural Nepal and will involve 250 snake bite~     victims presenting with one or more sign of neurotoxic envenoming. The objective of the study~     is to generate enough scientific evidence to improve Nepal's current national guidelines for~     the management of snake bites.~   "
174205|NCT01284842|"~     The study aimed to evaluate the effects of 24-Hour-Call-associated acute partial sleep~     deprivation on surgical residents` technical and cognitive performance in a virtual reality~     (VR) setting. Physiological parameters were used to quantify fatigue in respect to hours of~     sleep and subjective degrees of sleepiness. Technical performance and cognitive skills were~     assessed through low- and high fidelity tasks usig the VR- simulator LapSim. Objective~     alertness was measured by the standardized d2-Paper-Pencil-Test. Cited assessments were~     performed on three consecutive mornings- pre- and post-call as after 24 hours resting.~   "
174206|NCT01284829|"~     This is a prospective study which aims to validate a new diagnostic approach in the tissue~     characterization of adrenal tumors indeterminate on conventional imaging. For this purpose,~     it is not necessary to have a control group since the diagnostic accuracy in a well defined~     subset of patients.~      Visit 0 : Enrollment, eligibility. Visit 1 : FDG-PET. Visit 2 : Postoperative visit. Visit 3~     : 6 months post-PET. Visit 4 : 12 months post-PET.~   "
174207|NCT01284816|"~     Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese~     patients, especially those with metabolic complications, as it significantly reduces weight,~     hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and~     in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic improvement~     is associated with EAT reduction is also unknown.~      The researchers thus investigated the effect of bariatric surgery on EAT in severely obese~     patients. The primary endpoint of this study was the change in EAT amount 6 months after~     bariatric surgery.~   "
174208|NCT01284803|"~     Qualitative study based on interviews and questionnaires with patients participating to an~     educational intervention to improve the management of depression in primary care.~      Objective is to assess feasibility and acceptability of an educational intervention to~     improve the management of depression in primary care To elaborate an educational program for~     the management of depression in primary care.~   "
174209|NCT01284790|"~     Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people~     worldwide. While most patients show good scores of speech recognition in quiet, a large~     majority of them also struggle in more challenging listening situations, such as speech in~     noise or music. This project aims to understand the basic mechanisms of electrical~     stimulation of the auditory nerve, in order to identify the important cues that the~     electrical signal should convey and to possible improve sound perception by CI users.~   "
174219|NCT01284660|"~     The purpose of this study is to assess effects of Docosahexaenoic Acid (DHA) as an add-on~     novel supplement on quality of life, cognitive function, craving and psychosocial factors in~     heavy cigarette smokers. In humans, no previous randomized, double blind controlled study has~     been conducted to evaluate these effects. The aim of the study is to 1. Test Docosahexaenoic~     Acid (DHA) beneficial effects on objective clinical indicators of cognitive function (choice~     reaction time, decision making, impulsivity, facial recognition) in smokers 2. Improvement of~     quality of life, cigarette craving, psychosocial factors and self-perceptions in smokers~     treated with DHA supplement~   "
174220|NCT01284647|"~     The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic~     erosive gastritis and its therapeutic mechanism~   "
174221|NCT01284634|"~     The purpose of this study is to assess the effect of cannabidiol (CBD) on liver triglyceride~     (liver fat) in subjects with fatty liver disease.~   "
174222|NCT01284621|"~     Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if~     ramipril affects the pharmacokinetics of BI 10773.~   "
174210|NCT01284777|"~     Accurate characterization of malignant cells obtained via thoracocentesis is of paramount~     importance in the management of cancer patients. The identification of novel biomarkers may~     in that regard considerably improve the diagnostic approach of these pleural effusions, guide~     therapeutic decisions, particularly with respect to targeted therapies, and offer helpful~     prognostic information. Nuclear anomalies represent the cornerstone of the cytologic and/or~     histopathologic diagnosis of malignant cells. The nuclear matrix is a fundamental constituent~     of the nuclear architecture via its interaction with the nuclear membrane, but is also~     directly involved with DNA and RNA processing. Prior studies have suggested that in some~     cancers, the lamins, a major constituent of the nuclear matrix, have different patterns of~     expression or nuclear localization that could potentially have prognostic implications. Our~     project aims at studying the constituents of the nuclear matrix of malignant cells isolated~     for pleural fluid in patients with metastatic disease, both of bronchogenic or~     non-bronchogenic origin, which, to our knowledge, has not yet been done. Both proteomic~     (localization by immunofluorescence and expression by Western-Blot) and genomic (microarray,~     CGH type) analyses will be undertaken to identify microrearrangements in the genes of~     interest. The primary aim is to identify specific biomarkers to more accurately characterize~     malignant cells in metastatic pleural disease.~   "
174211|NCT01284764|"~     A low volume of water intake and mosapride will effectively reduce food residue in remnant~     stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.~   "
174212|NCT01284751|"~     The purpose of this study is to measure depressive symptoms in breast cancer patients before~     surgery with Major Depression Inventory (MDI). The investigators hypothesize that this~     patient group will not produce scores correlating to having a mild, moderate or severe~     depression even though they have just recently experienced a major life crisis by receiving a~     malignant diagnosis.~   "
174213|NCT01284738|"~     The results will allow us to evaluate the role of MP in the thrombo-embolic risk observed in~     thalassemic patients and to underline a possible difference between TM and TI. The in vitro~     and in vivo study of MP in erythrocytes concentrates is a new approach to explore the~     consequence of transfusion in polytransfused patients. Finally, the identification of a~     possible relationship between the oxidative stress and the production of MP may lead to the~     development of specific therapeutical approaches~   "
174214|NCT01284725|"~     The investigators wish to evaluate the discontinuation of maintenance immunosuppressive~     treatment after 2 years in patients with stable remission after a proliferative lupus~     nephritis. The patients will be continuing their treatment with hydroxychloroquine, possibly~     associated with low dose corticosteroids.~   "
174215|NCT01284712|"~     Natural Killer cells (NK) are pivotal cells of innate immunity, that sense defective~     expression of HLA class I molecules and are complementary to specific cytotoxic T~     lymphocytes. A defect in NK cell cytotoxicity has been described in some hematopoietic~     malignancies such as acute myeloid leukemia, multiple myeloma, myelodysplastic syndroms. This~     defect is at least partially linked to a decreased or absent expression of some activating NK~     cell molecules, more particularly the so-called Natural Cytotoxicity Receptors (NCRs) NKp30,~     NKp44 and NKp46. Some old publications have demonstrated defective NK cytotoxicity in~     myeloproliferative syndroms (chronic myeloid leukemia, primary thrombocytosis, polycythemia~     vera). The investigators more particularly focused their attention on polycythemia vera~     (Vaquez's disease), a myeloproliferative disease characterized by the recently describet~     mutation V617F of the JAK2 tyrosine kinase. The investigators will precise the mechanisms~     leading to this cytotoxicity defect, the investigators also will evaluate the implication of~     V617F mutation on NK physiology, and will study the interactions between NK cells and~     hematopoietic progenitors.~   "
174216|NCT01284699|"~     The goal of our trial is to evaluate the tolerance and efficacy of the STN radiosurgery in~     Parkinsonian patients presenting with the inclusion criteria for the STN stimulation but~     presenting also with clear contraindications to the implantation of the deep brain~     electrodes.~   "
174217|NCT01284686|"~     Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is~     abnormally synchronised and rhythmic. The oscillatory activity prevails at 8-30 Hz in~     untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels~     inversely correlates with motor impairment. Moreover, these different levels in BG-cortical~     loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment~     following treatment with dopaminergic drugs and is partially suppressed prior to and during~     voluntary movements. An unanswered question is how do BG-cortical loops become so prominently~     engaged in this oscillatory activity? One possible explanation is that the resonance~     frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that~     oscillations in this band are transmitted particularly well. This hypothesis was confirmed in~     a previous series of experiments.The aim is to determine whether the resonance frequency~     within BG-cortical loops is correlated to the BG-cortical coherence frequency (with 20~     subjets during 24 months).~   "
174218|NCT01284673|"~     Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain~     asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal~     damage and loss.~      For the moment, only total or partial body hypothermia can partially prevent cell loss.~     However, no treatment exists to restore neuronal functions.~      Cord blood stem cells are a promising treatment for the near future. However, before~     conducting a clinical trial to evaluate the safety and feasibility of autologous cell therapy~     in neonatal asphyxia, in vitro characterization of the cord blood stem cell in situation of~     neonatal asphyxia, compared to normal situation, is needed.~      The primary objective of this study is to characterize cord blood stem cells of neonates with~     neonatal asphyxia and to compare them with those from healthy newborn. The quantitative and~     qualitative, functional characterization will insist on cell populations which could~     potentially participate to neuronal regeneration. Secondary objectives are to assess such~     characteristics in conditions of cryo-preservation, compared to fresh cell preparation~   "
174223|NCT01284608|"~     This is an observational, prospective, non-interventional and multi-centre study, to assess~     the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body~     fat distribution and fracture risk to ten years using FRAX model in patients with prostate~     cancer. The patients will be following for 12 months~   "
174224|NCT01284595|"~     Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose~     Oral Administration~   "
174231|NCT01284504|"~     The proposed study aims to investigate how the administration of a drug known to reduce~     inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a~     patient undergoing primary tumor resection surgery for colon cancer. The proposed project is~     an exploratory study, and will use data from blood samples and tumor samples to attempt to~     elucidate the immune and inflammatory response in colon cancer patients undergoing primary~     resection of their tumors.~   "
174232|NCT01284491|"~     The objective of this clinical study is to evaluate scar quality following incision with the~     PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to~     compare these results to equivalently-aged scars formed following incision with a standard~     scalpel.~   "
174233|NCT01284478|"~     The purpose of the study is to determine where a sustained steroid delivery system~     (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients~     after Cataract Surgery~   "
174234|NCT01284465|"~     The purpose of this study is to assess the extent to which a culturally appropriate,~     self-management intervention that combines patient education with a patient outreach liaison~     strategy improves outcomes associated with type-2 diabetes among low-income diabetic women.~   "
174235|NCT01284452|"~     Severe sepsis/septic shock is a serious condition associated with high mortality rate.~     Hydrocortisone has been recommended as a useful treatment to decrease mortality in~     hemodynamically unstable septic shock patients, not response to fluid and moderate dose of~     vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction~     can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome~     (ARDS) is one of the common organ dysfunction associated with septic shock. Information from~     a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients'~     outcome. Whether hydrocortisone can effectively prevent disease progression and death in~     severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.~   "
174236|NCT01284439|"~     To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the~     treatment of ocular surface disease in glaucoma patients.~   "
174237|NCT01284426|"~     The purpose of this study is to examine the natural history of chronic urticaria in children~     and to identify the predictors for chronic urticaria remission.~   "
174238|NCT01284413|"~     The objective of this study is to evaluate the safety of GCS therapy for phase I and efficacy~     of GCS therapy for phase II.~   "
174239|NCT01284400|"~     Although many studies have demonstrated the efficacy of disease management programs on~     mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure~     (HF), no study has focused on psychological status as an outcome of disease management in~     patients with HF. Disease management could lead to the reduction of psychological distress,~     thus improving the self-care ability and adherence of patients with HF. In addition, very~     little information is available on the effectiveness of disease management programs in areas~     other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and~     Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the~     efficacy of home-based disease management programs compared with usual care in improving~     psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.~   "
174240|NCT01284387|"~     A Phase II clinical research study to evaluate the efficacy and safety of two different dose~     levels of an injectable investigational treatment (ACC-001) in subjects with Mild-to-Moderate~     Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid fragment attached to a~     carrier protein. It is intended to help induce an antibody response against beta amyloid and~     is administered as an intramuscular injection.~   "
174241|NCT01284374|"~     The objectives of this study are:~        1. To better understand factors associated with acceptance and refusal of HPV vaccine among~          parent-son pairs and the process of parent-son decision-making with respect to~          vaccination.~        2. To evaluate health care providers (HCPs) attitudes, implementation intentions, and~          planned communication strategies with respect to HPV vaccination of adolescent boys.~      Hypothesis 1: Sons will have a significant role in the process of parent-son decision-making~     about HPV vaccination. The relative importance of this role will increase with the son's age.~      Hypothesis 2: Pediatric HCPs will be unsure about vaccinating males and will lack knowledge~     about issues related to male HPV infection and vaccination.~   "
174242|NCT01284361|"~     This is an unblinded, multi-center, randomized, controlled, cross-over study assessing~     wheel-chair bound, male user preference and catheter characteristics of two intermittent~     urinary catheters. Subjects enrolled in the study will be randomized to order of catheter~     use. Individual participation will consist of approximately 1 week of product use. The null~     hypothesis to be tested is there no difference between catheters.~   "
174243|NCT01284348|"~     The purpose of this study was to determine an effective and safe dose of ACE-011 for the~     treatment of chemotherapy induced anemia (CIA) in participants with metastatic non-small cell~     lung cancer who are being treated with first-line platinum based chemotherapy.~   "
174244|NCT01284335|"~     The purpose of this study is to determine a safe dose of LY573636-sodium when used in 5~     separate combinations with an approved cancer medication for treating patients with advanced~     cancer. Data from this study will be reviewed for any side effects or anti-tumor activity~     that may be associated with the LY573636-sodium combination treatments.~   "
174245|NCT01284322|"~     The purpose of this study is to determine if fresolimumab is safe in treating people with~     systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin of~     these individuals.~   "
174246|NCT01284309|"~     The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP)~     in healthy subjects.~   "
174247|NCT01284296|"~     This study will further investigate the Masimo SpHb [FDA Approved] continuous non-invasive~     hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the~     effect of enhanced circulation to the finger (which will be attached to the sensor) following~     a local injection (digital block) of lidocaine (an FDA approved local anesthetic), and assess~     the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value~     (tHb).~   "
174248|NCT01284283|"~     This post-approval study is being conducted to examine the performance of the STAR Ankle~     under actual conditions of use.~   "
174249|NCT01284270|"~     The purpose of this study is to evaluate whether some features of plaques in coronary~     arteries predispose the heart muscle to injuries during angioplasty in patients with a~     narrowing in at least one of the arteries that may need a stent placed during a heart~     catheterization. Participants undergo a cardiovascular magnetic resonance imaging (MRI) study~     before the heart catheterization to look for scarring in the heart muscle. During the heart~     catheterization, participants undergo an intravascular ultrasound (IVUS) exam to look at the~     make-up of the plaques before the stent placement and the investigators will measure the~     pressures in the arteries to look at how severe the blockage is. Within 30 days after the~     heart catheterization, participants will have a second MRI done to look for any new scar in~     the heart muscle.~   "
174250|NCT01284257|"~     The MORE Observational Study follows real-world renal transplant patients with the data~     resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing~     detailed clinical data, the study describes recent important changes in surveillance testing~     and drug therapy and relates these changes to short and long-term outcomes. Also, the study~     measures patient compliance over time and details the rationale for modifications of MPA~     dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide~     information on era changes in transplant practices and their impact on clinical outcome, new~     insights on optimizing regimens for discrete patient subsets and new perspectives on the~     optimal use of MPA therapy.~   "
174251|NCT01284244|"~     Stress urinary incontinence (SUI) is defined as the involuntary loss of urine with an~     increase in abdominal pressure, caused either by a loss of support under the bladder neck, or~     intrinsic urethral sphincter deficiency. It is a common problem in women that can~     significantly impact quality of life, with up to 30% developing SUI at some point in their~     lifetime.~      The most commonly utilized treatments for SUI include either pelvic floor (Kegel) exercises,~     or surgery. Many women find Kegel exercises unsatisfactory, but are reluctant to undergo a~     surgical procedure. Also, women who are poor candidates for surgery have limited options if~     Kegel exercises are unsuccessful. Over the years, there have been numerous attempts to~     develop effective non-surgical alternatives for treating SUI, but the results have been~     variable and the available data on efficacy limited.~      A new intravaginal incontinence pessary (Uresta) has been developed for treating stress~     incontinence, and is currently available in Canada via a medical distributor. The~     self-positioning device is initially fitted by a healthcare provider, but then can~     subsequently placed by the patient as needed. Uresta is designed to be easily inserted into~     the vagina and spontaneously fall into position, providing support beneath the urethra. A~     single, uncontrolled study of 21 women showed that Uresta significantly reduces urinary~     incontinence measures, with no reported complications. Using questionnaires, a 47% reduction~     in self-reported SUI symptoms was demonstrated. Pad weight following a pad test, an objective~     assessment of urine loss, showed a 50% reduction in leakage.~      This trial is intended to be a short-term assessment of the efficacy of the Uresta device,~     using a placebo arm in order to remove any of the possible sources of patient biases. The~     placebo (sham) group will be obtained by placing a flexible silastic ring (inactivated~     Estring) high in the vagina where it will not alter urethral forces. The aim is to~     unequivocally determine whether the Uresta device provides the necessary urethral support to~     stop urine leakage from stress incontinence.~      The hypothesis is that the Uresta device will significantly reduce urinary losses from~     baseline, shown as a significant reduction pad weight following a pad test with the device in~     place.~   "
174252|NCT01284231|"~     To determine the maximum tolerated dose and/or optimum biologic dose of MEDI-565 in adult~     subjects and evaluate the safety profile in adult subjects with advanced gastrointestinal~     adenocarcinomas who have no available standard or curative treatments.~   "
174253|NCT01284218|"~     To examine the differences in health care utilization and costs between MDD patients on~     adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.~   "
174254|NCT01284205|"~     The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as~     first line treatment in patients with non-muscle invasive bladder cancer that are at high~     risk for recurrence or progression.~   "
174255|NCT01284192|"~     This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with~     advanced malignancies (solid tumors and B-cell lymphoma).~   "
174256|NCT01284179|"~     The primary aim is to develop and test the feasibility of a standardized digital audio~     home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP).~      The secondary aims of this study are:~        1. To obtain pilot data to assess the magnitude of the treatment effect of self-hypnosis in~          refractory FCP for an anticipated future, larger treatment trial;~        2. To determine the stability of the treatment effect of HHT in refractory FCP;~        3. To assess the relationship between response to HHT and psychological factors; and~        4. To assess the relationship between response to HHT and symptomatic dimensions of chest~          pain (severity, frequency, and duration).~        5. To assess the difference~   "
174257|NCT01284166|"~     This study will investigate the safety and efficacy of Triple Combination Therapy with~     dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with~     glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol~     maleate combination therapy.~   "
174258|NCT01284153|"~     This study has the purpose to investigate the benefit of treating breast cancer patients in~     prone position. This treatment is compared to the standard technique in our center (supine~     position with or without respiratory gating). The investigators want to compare the doses on~     the organs at risk (heart and lungs) in the different techniques.~   "
174259|NCT01284140|"~     The goal of this project is to determine whether the sleep and circadian rhythms of~     critically ill patients undergoing mechanical ventilation can be improved through practical~     strategies that can be employed at the bedside.~   "
174273|NCT01283958|"~     Identification of the pathophysiology associated with Eisenmenger's syndrome has led to the~     evaluation of targeted therapies. Iloprost, a prostacyclin analogue, is one such targeted~     therapy used in patients with Eisenmenger's syndrome. The purpose of our study is to assess~     the effects of inhaled iloprost on patients with Eisenmenger's syndrome.~   "
174274|NCT01283945|"~     Co-selective inhibition of VEGFRs and FGFR has the potential benefit of blocking the two most~     relevant players in tumor angiogenesis and simultaneously targeting proliferation in~     FGF-driven tumors. Lucitanib is a novel dual-targeted small molecule inhibitor of VEGFR1, 2,~     3 and FGFR1 showing strong anti-angiogenic and anti-tumor activity in preclinical models at~     well-tolerated oral doses, with a favorable pharmacokinetic profile. These properties make it~     an attractive candidate for development in humans.~      This is an open-label, uncontrolled, non-randomized, PhaseI/IIa study and its primary~     objective is to determine the Maximum Tolerated Dose (MTD) of Lucitanib administered orally,~     once daily, on a continuous schedule over the initial 28-day cycle.~      Secondary objectives are to determine the safety profile, pharmacokinetics, pharmacodynamics~     and antitumour activity of Lucitanib, given as a single agent to adult patients with advanced~     solid tumours.~      The study consists of two phases, a dose escalation phase followed by a dose-expansion phase~     at the identified Recommended Dose (RD). Eligible patients have histologically or~     cytologically confirmed locally advanced or metastatic solid tumours, relapsed or refractory~     to standard therapy. For the dose expansion, patients should have tumours bearing FGFR1 or~     11q 12-14 amplification, assessed by FISH or CGH array, or sensitive to antiangiogenic~     treatment. These latter are defined as patients who have relapsed after having experienced~     stable disease (lasting at least six months) or partial response with prior treatment with an~     approved antiangiogenic regimen or patients with tumour types known to be potentially~     responsive to antiangiogenic agents but without such pretreatment if no antiangiogenic agents~     were approved and/or available for that specific condition (e.g thyroid cancer, thymic~     carcinoma).~      Serial safety assessments, including evaluation of symptoms, physical examination and blood~     and urine laboratory analyses are performed throughout the study. Cardiac functions and blood~     pressure are monitored in consultation with a cardiologist. PK parameters are determined on~     plasma samples collected during the first 4-week cycle and analyzed using a validated~     LC-MS/MS method. Correlative studies include: (i) quantitative assessment of the effects of~     E-3810 on tumor vasculature by DCE-MRI and DCE-US imaging; (ii) assay of angiogenesis~     biomarkers i.e. soluble VEGFR2, VEGFR1, VEGF, bFGF, Collagen IV, FGF23 and PIGF(by ELISA) and~     circulating endothelial and progenitors cells (CEC and CEP). Tumor response is based on~     imaging according to RECIST; circulating tumor cells (CTC) are measured by the immunomagnetic~     CellSearch method.~      In patients with tumours bearing FGFR1 amplifications the efficacy of Lucitanib will be~     formally tested according to a phase IIa design (one-stage Flaming design, H0=0.05, H1=0,30,~     power 0,80.~   "
174275|NCT01283932|"~     To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release~     tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets~     (Wyeth Laboratories, USA) in 52 (+ 6 standby) healthy, adult, human subjects under fasting~     conditions.~   "
174276|NCT01283919|"~     To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release~     tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets~     (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting~     conditions.~   "
174635|NCT01279213|"~     augmentation of clozapine with paliperidone in the treatment of resistant schizophrenia has~     not been tested until now in randomized controlled trials. This combination is supposed to~     have therapeutic efficacy in the treatment of resistant schizophrenia.~   "
174260|NCT01284127|"~     Superficial siderosis is a progressive neurological disease caused by iron deposition in the~     central nervous system from chronic subarachnoid bleeding. Until 2011, there has been no~     effective treatment for this progressive condition that leads to hearing loss, spasticity,~     weakness, loss of bowel/bladder function, incoordination, dementia and ultimately death.~      Last year, we demonstrated that a lipid soluble iron chelator, deferiprone, can reduce~     hemosiderin deposition in patients with superficial siderosis by MRI in as little as 3~     months. As the only therapy that can improve this condition, chelation with deferiprone is~     the standard of care for treatment of superficial siderosis. Now that the FDA has approved~     deferiprone in the United States for thalassemia, we propose documenting the clinical effect~     of deferiprone over 2 years in superficial siderosis patients. Our goal is to understand how~     the clinical course of this disease is altered using standard of care chelation therapy with~     deferiprone.~      Patients with superficial siderosis who are taking deferiprone for chelation therapy at doses~     consistent with the standard of care will be offered enrollment into this observational~     study. Patients will be treated and monitored locally by participating neurologists who have~     agreed to help us collect information for this study. We are interested in documenting the~     clinical effect of deferiprone on hearing, ataxia and myelopathy using standardized scales~     performed and documenting the effect of deferiprone on hemosiderin deposition in the CNS by~     MRI, all performed according to standard of care.~   "
174261|NCT01284114|"~     The purpose of this study is to determine whether aliskiren is effective in the treatment of~     blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease~     (CKD) patients.~   "
174262|NCT01284101|"~     The Tan EndoGlide device results in less endothelial cell trauma during insertion of the~     donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared~     to the Forceps.~   "
174263|NCT01284088|"~     The World Health Organization and UNAIDS cite that male circumcision can reduce the lifetime~     risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa.~      Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men~     in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the~     government is continuing to study the PrePex™ device, developed to enable rapid adult male~     circumcision in resource limited settings.~      The study will enroll one hundred and fifty (150) persons scheduled for voluntary~     circumcision. The subjects will be randomly divided into two unbalanced study arms, PrePex™~     arm which will include about a hundred and twenty (100) subjects and surgical circumcision~     arm which will include about sixty (50) subjects.~      Study duration per subject will be 9 weeks.~   "
174264|NCT01284075|"~     This pilot study will be a prospective, randomized trial which will take place at the~     University of Minnesota Medical Center (UMMC). Eligible patients will be identified at the~     time of their first clinic visit. If selected to be involved in the study, the patients will~     be randomized to one of three different groups: a Guided Imagery and Music therapy group~     (GIMT) or one of two control groups.~   "
174265|NCT01284062|"~     This study represents the first investigation of anrukinzumab in patients with active~     ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism~     based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and~     hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics~     (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.~   "
174266|NCT01284049|"~     The objective of the study is to show that substitution of the usual lipid emulsion~     (Intralipid 20%®) at a dose between 0.5 and 1.0 g/kg/infusion of parenteral nutrition~     (n-6:n-3 ratio = 7:1) by an equivalent dose of 0.5 to 1 g/kg/infusion of another lipid~     emulsion, OMEGAVEN 10%® very rich in omega-3 (n-3) (n-6:n-3 ratio = 1:7) induces regression~     of PNALD due to the anti-inflammatory and anti-fibrotic effects of n-3 EFA.~      Regression of liver disease will be defined by normalization of the five liver function tests~     (LFT): conjugated bilirubin, gamma GT, alkaline phosphatase, AST and ALT transaminases.~   "
174267|NCT01284036|"~     The purpose of this study is to find the safety and side effects of investigational drug in~     healthy volunteers. See how quickly investigational drug enters the bloodstream, is~     distributed in the body, broken down and removed in healthy male and female volunteers. See~     if your body makes antibodies to this investigational drug (how your immune system responds).~   "
174268|NCT01284023|"~     Acute compartment syndrome (ACS) is a complication of lower leg trauma that occurs when the~     pressure inside the leg due to swelling exceeds the body's ability to provide blood to the~     muscle of the leg. This condition cuts off blood flow to the leg. Left untreated, the~     condition can result in devastating consequences including complete loss of function of the~     lower extremity or amputation. Near-infrared spectroscopy (NIRS)-based tissue perfusion~     monitors are a non-invasive means of continuously monitoring the amount of oxygen in the~     tissues of an injured extremity. The device utilizes harmless red light to detect the~     proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface. The purpose~     of this study will be to launch the first stages of validation of this device as a diagnostic~     tool for compartment syndrome, by observing this device in uninjured subjects.~   "
174269|NCT01284010|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from~     patients with acute lymphoblastic leukemia.~   "
174270|NCT01283997|"~     The goal of this clinical research study is to see if Minocin® (minocycline) can help to~     control nerve damage that causes numbness and tingling in the hands and feet (neuropathy) in~     patients receiving thalidomide and/or bortezomib.~   "
174271|NCT01283984|"~     AZD2115 Single Ascending Dose Study~   "
174272|NCT01283971|"~     This randomized, parallel-group study will assess the efficacy and safety of~     RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate~     (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already~     treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8~     mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks.~     All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly).~     The anticipated time on study treatment is 24 weeks.~   "
174277|NCT01283906|"~     This study is a randomized, double-blind, sham-controlled, two-arm study conducted in~     subjects receiving chemoradiation therapy for the treatment of head and neck cancer to assess~     the efficacy of MuGard. The study will evaluate the ability of MuGard to reduce the symptoms~     of oral mucositis. The study includes a treatment period of approximately 7 weeks depending~     on the subject's prescribed radiation plan.~      MuGard is a liquid that is classified as a medical device. It is a hydrated polymer system~     (oral hydrogel) and is intended for the management of oral mucositis/stomatitis. When gently~     distributed within the mouth, the mucoadhesive formulation results in the formation of a~     protective coating over the oral mucosa. Subjects undergoing chemotherapy with radiation for~     the treatment of head and neck cancer are at high risk of developing oral mucositis as an~     adverse side-effect of cancer treatment. MuGard was previously shown to reduce the incidence~     and severity of mucositis in head and neck cancer patients undergoing radiation therapy when~     compared with data from historical control groups. The purpose of this study is to perform a~     direct comparison of the effectiveness of MuGard with a control group.~   "
174278|NCT01283893|"~     Gastric cancer is one of the most common cancers in Korea. Having achieved excellent~     long-term survival for early gastric cancer patients, there is a growing interest in~     improving the quality of life of these patients without compromising their prognosis.~     Laparoscopic surgery for early gastric cancer have been found to be safe and feasible with~     superior short-term outcomes. Although laparoscopic gastrectomy with D2 lymphadenectomy is~     being performed for patients with locally advanced gastric cancer; the completeness of the D2~     lymphadenectomy during laparoscopic surgery has not been evaluate and no standardized~     procedure exists. To conduct a clinical trial comparing laparoscopic D2 lymphadenectomy to~     the open approach, quality control of D2 lymphadenectomy procedure is necessary.~   "
174279|NCT01283880|"~     Metabolic acidosis is a common complication in incident renal transplant recipients.~     Protracted acidosis may be associated with osteoporosis, inflammation, negative protein~     balance and malnutrition, and last but not least may cause renal dysfunction. Preliminary~     data indicate an increased prevalence of nephrocalcinosis in renal transplant biopsies of~     incident patients presenting with metabolic acidosis. The present study aims (1)evaluate the~     prevalence and type of renal tubular acidosis (RTA) in incident renal transplant recipients~     and to identify clinical correlates and (2) to find associations between RTA, nephrolithiasis~     and nephrocalcinosis~   "
174280|NCT01283867|"~     To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's~     test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in~     healthy, adult, human male subjects under non-fasting conditions and to assess the~     bioequivalence.~   "
174281|NCT01283854|"~     Gestational diabetes mellitus (GDM) is one of the most common medical complications of~     pregnancy and has serious health implications for both the pregnant woman and her child. In~     particular, offspring of mothers with GDM have an increased prevalence of obesity, diabetes~     and metabolic syndrome, perpetuating serious health consequences in subsequent generations.~      Although regular exercise offers numerous benefits for both the mother and her child, its~     effectiveness in preventing GDM remains to be established. It has been recently shown that~     regular supervised home-based exercise may attenuate the decline in glucose tolerance in~     obese pregnant women. This study aims to conduct a single-centred, multi-sited,~     single-blinded randomised controlled trial examining the effect of 14 weeks of supervised~     home-based exercise (commenced at 14 weeks gestation) on the recurrence and severity of GDM,~     along with other aspects of maternal and fetal wellbeing.~      Eligible participants (n = 200) will be randomly allocated to an exercise intervention (n =~     100) or a control group (n = 100). The exercise intervention will involve three 60-minute~     home-based, supervised exercise sessions each week. This type of program overcomes many of~     the barriers to exercise in this population including transportation, child care issues and~     embarrassment associated with exercising in a public venue. The investigators have already~     shown this program to be both feasible and warmly accepted by obese pregnant women.~   "
174282|NCT01283841|"~     To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's~     test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in~     healthy, adult, human male subjects under fasting conditions and to assess the~     bioequivalence.~   "
174283|NCT01283828|"~     This primary goals of this study are to: estimate the prevalence of Clostridium sordellii and~     Clostridium perfringens carriage in the rectum and/or vagina among women of reproductive age;~     estimate duration of carriage of the two clostridium species; and estimate the incidence of~     carriage at 2 weeks after a negative test.~   "
174284|NCT01283815|"~     According to retrospective studies the conservative management of periappendicular abscess is~     associated with decreased complication and re-operation rate compared with open appendectomy.~     Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not~     possible because of anatomical position of the abscess and surgical treatment is needed. The~     purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the~     first-line treatment in patients with periappendicular abscess.~      The hypothesis of the study is that laparoscopic management of periappendicular abscess is~     suitable for the first-line treatment and it does not increase time of hospitalization or~     complication rate compared with conservative management.~   "
174285|NCT01283802|"~     Liver surgery should be considered an echo-guided procedure to guarantee conservative but~     radical resections. The investigators describe a further application of intraoperative~     ultrasonography (IOUS) for studying the biliary tree during liver surgery with no need for~     formal cholangiography.~   "
174286|NCT01283789|"~     By doing this study, researchers hope to learn the effectiveness of the combination of~     Lapatinib and RAD-001 for treating patients who have progressed on previous therapies.~   "
174287|NCT01283776|"~     A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as~     single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in~     patients with multiple myeloma or lymphoma and to describe the influence of the modified~     immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution~     and chimerism.~   "
174288|NCT01283763|"~     The purpose of this study is to investigate the non-inferiority of a topical Imiquimod~     therapy in patients with persistent CIN 2/3 when compared to standard therapy, i.e.~     conization A randomized, controlled, non-inferiority AGO-Austria trial~   "
174289|NCT01283750|"~     Funded by a unique private philanthropy and public coalition through THE ASSOCIATED: Jewish~     Community Federation of Baltimore, this project seeks to develop effective ways to deliver~     dementia care to older adults with memory disorders who live in the community. MIND at Home~     is an 18 month intervention research study whose goals are two-fold: To partner with~     community organizations to help proactively identify older adults in the Baltimore community~     who may need help related to memory disorders; To find out if providing person-centered,~     coordinated care will help older adults with memory disorders remain at home longer, as well~     other possible benefits. The investigators hypothesize that individuals with memory disorders~     that receive person-centered, coordinated care will have fewer unmet dementia-related needs,~     improved quality of life and function, fewer behavioral and depressive symptoms, and will be~     able to remain in their homes longer compared to individuals who receive augmented usual~     care.~   "
174290|NCT01283737|"~     This is a 1:1 randomised pilot study in 30 patients in 1 site in Helsinki, Finland.~      The investigators hypothesize that function, pain, type and quality of cartilage in adult~     patients with osteochondritis dissecans of the knee will be better in the DBX group compared~     to the mosaicplasty group.~   "
174291|NCT01283724|"~     A clinical trial which was designed to demonstrate the safety and efficacy of Visanne~     (approved in endometriosis for adults) in the adolescent population.~   "
174292|NCT01283711|"~     Non-invasive, energy-based, aesthetic treatments are becoming increasingly popular among~     female and male patients of all ages. Different technologies are presently available to~     rejuvenate skin, including therapeutic ultrasound, lasers and intense pulsed light (IPL),~     however radiofrequency has emerged as the most effective and versatile modality for the~     broadest range of body and facial treatments, including non-invasive wrinkle treatment.~      The apollo™ system is an RF system, based on the TriPollar™ technology. The technology is~     based on three or more electrodes designed to deliver RF current focused into the skin, thus~     generating heat in the dermal layer. Selective and focused electro-heating of the skin is~     intended to stimulate collagen remodeling in the dermal layer resulting in non invasive~     wrinkle treatment.~      The apollo™ system is intended for use in dermatologic and general surgical procedures for~     non invasive treatment of facial wrinkles and rhytides. This study was designed in order to~     evaluate the safety and efficacy of the Apollo™ System for facial wrinkles and rhytides~     treatments.~   "
174293|NCT01283698|"~     The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004~     in a Psoriasis Plaque Test (PPT)~   "
174294|NCT01283685|"~     Regular exercise can help patients with the lung disease, chronic obstructive pulmonary~     disease (COPD). But COPD patients have a hard time with training because of their breathing.~     To improve their program they can train with one leg at a time. Another way is to make their~     exercise easier by breathing helium. Putting two methods, one-legged and helium, together may~     improve their program even more. This project is planned to assess whether breathing helium~     improves their one-legged exercise endurance. If it does, then there may be a reason for~     combining one-legged exercise with breathing helium as part of their respiratory~     rehabilitation program. The aim of this study is to determine whether breathing~     helium-hyperoxia enables a further increase in the constant power endurance time during~     one-legged exercise in ventilatory limited subjects with COPD. The null hypothesis is that~     patients will have sufficient peripheral muscle limitation that ventilatory unloading using~     helium-hyperoxia will be of no additional benefit to exercise tolerance. The investigators~     hypothesize that patients with COPD are so ventilatory limited relative to their peripheral~     muscles that helium-hyperoxia will improve their exercise endurance.~   "
174295|NCT01283672|"~     The objectives of this study are the following: 1) to determine the acute effect of whole~     grain barley on risk factors of cardiovascular disease compared to a diet low in whole grain,~     and 2) to compare the effects of whole grain barley to those of whole grain oats to determine~     if the response to these two grains is similar.~   "
174296|NCT01283659|"~     Background: The prevalence of heart failure (HF) is rapidly rising in industrialized and~     developing countries. Though invasive coronary angiography (ICA) remains the gold standard~     for anatomical assessment of coronary arteries and luminal stenoses in these patients,~     alternatives have been sought. Computed tomographic coronary angiography (CTA) has emerged as~     an accurate non-invasive diagnostic tool for CAD and has been demonstrated to have prognostic~     value. Whether or not CTA can be used in patients with HF for diagnosis and to guide patient~     investigations and management is unknown. Acknowledging the aging population in~     industrialized counties, the increasing burden of healthcare and growing prevalence of HF,~     there is a need to identify non-invasive diagnostic tests that are cost-effective, readily~     available, safe and of sufficient accuracy to risk stratify patients and guide investigations~     and management.~      Methods: The proposed randomized controlled trial (RCT) will evaluate the clinical utility of~     computed tomographic coronary angiography (CTA) and investigate its potential benefit on~     resource utilization and health economics in patients with progressive or newly diagnosed~     heart failure (HF) of unknown etiology (i.e. ischemic versus non- ischemic) or in whom the~     definition of coronary anatomy is required for diagnosis and management. The experimental~     algorithm will be compared to invasive coronary angiography (ICA)~      Analysis of composite clinical events and major adverse cardiac events will be performed to~     determine the impact of these strategies upon patient outcomes. Accuracy of CTA in detection~     of coronary anatomy and obstruction will be assessed in patients undergoing ICA. It is~     expected that CTA will be a more cost-effective strategy for diagnosis; yielding similar~     outcomes with fewer procedural risks and improved resource utilization.~   "
174297|NCT01283646|"~     Lack of appetite is one of the most common reasons for visits to pediatric clinics.The~     symptoms usually manifest after weaning when they are introduced into the diet of infant~     foods containing salt.Is normally used to cyproheptadine in conjunction with vitamins C and B~     and also vitamins complex.~   "
174298|NCT01283633|"~     In recent years, robotic devices are becoming more and more common in medical practice. Such~     devices provide an effective way to communicate within a clinical setting, but recent studies~     have shown far more diverse uses for these robots, ranging from training future surgeons to~     diagnoses of patients. In the investigators study, the investigators would like to~     investigate whether it is effective to employ robotic devices in the administration of~     neurostimulation treatment. It is the investigators hypothesis that the introduction of~     robotic devices will only yield minimal if any inaccuracies in a standard neuromodulation~     treatment protocol. In addition, the investigators also predict a high satisfaction rating~     from all participants involved in conditions involving the robot.~   "
174331|NCT01283204|"~     This study is to evaluate the antitumor activity (i.e. progression free survival, overall~     survival, response rate, etc), safety and quality of life in patient with recurrent or~     metastatic gastric cancer during 4-regimen (i.e. SP, FL/Tax, FL/Doc, FOLFOX) based~     chemotherapy. In addition, it is to evaluate efficacy and adverse events of anticancer agents~     according to the results of pharmacogenetic study.~   "
174332|NCT01283191|"~     While physical activity has been associated with decreased craving and increased abstinence~     rates in smokers, few published studies have examined the effects of exercise on recovery~     from other drugs such as cocaine. One factor that has impeded such research has been low~     levels of patient compliance with exercise protocols. One robust strategy for promoting and~     maintaining behavior change is contingency management or Behavioral Incentives (BI). BI~     delivers incentives (prizes, vouchers) contingent upon target behaviors such as cocaine~     abstinence (Higgins et al., 1994); treatment attendance (Svikis et al., 1997) and other~     pro-social behaviors (Kirby et al., 1998). While the literature is replete with studies~     demonstrating the benefit of BI compared to control conditions (Stitzer & Petry, 2006), the~     translation of BI methods from research to clinical practice has met with some resistance.~     Contributing factors include philosophical differences (e.g., counselors feel extrinsic~     reinforcement undermines recovery) and practical barriers (e.g., monetary costs of incentives~     may be prohibitive). The latter concern was addressed by Petry (2005) who developed the fish~     bowl method, which uses escalating variable ratio procedures to reduce per patient costs of~     BI with similar effect sizes.~      As a Stage 1 behavioral therapies development grant (Rounsaville et al., 2001), the primary~     aim of this research is to pilot test a BI intervention designed to promote regular physical~     activity in a sample of women receiving inpatient treatment for SUDs. The target behavior,~     physical activity, will be objectively defined as 30 minutes of observed treadmill walking at~     any intensity 3 days/week at Level 1, and 30 minutes of higher intensity physical activity~     that meets ACSM criteria for moderate exercise Level 2. Specifically, a pilot randomized~     clinical trial will compare rates of physical activity over a 6 week study period in a sample~     of N=50 women with Cocaine Dependence. All participants will complete baseline assessment,~     attend a 45-min Health and Fitness (HF) education group, followed by random assignment to~     either the experimental (BI) or control (C) groups, with equal daily access to on-site~     treadmills. Those randomized to BI, however, will also be eligible 3 days/week, to receive~     incentives for completing 30 minutes of treadmill walking.~      Incentives will be dispensed using Petry Fish Bowl methods. Women assigned to the BI group~     will receive behavioral incentives (in the form of gift cards or prizes) for completing their~     scheduled exercise sessions (Level 1), and have the opportunity to earn bonus draws for~     meeting moderate intensity exercise criteria, as specified by ACSM (2007, revised) guidelines~     (Level 2). In Level 1, the number of tokens participants can draw from the gym bag (present~     study equivalent to fishbowl) at each visit will be linked to exercise session attendance,~     with consistent attendance resulting in greater number of draws. In Level 2, the number of~     tokens a participant can draw from the gym bag will be linked to the intensity of the~     participant's exercise. Specifically, beginning in Week 2 of the study, participants will be~     re-evaluated for exercise capability. Those who pass the safety screen will be encouraged to~     exercise at a higher intensity, and those who do not will be re-evaluated until they obtain~     safety clearance. Once cleared, if the participant meets criteria for moderate exercise~     during her scheduled session, then she will be allotted a bonus draw (Level 2) for meeting~     Level 2 criteria, in addition to the escalating number of draws she would received for~     scheduled exercise session completion (Level 1).~      Scheduled treadmill walking will be monitored and recorded for both BI and C group women.~     Follow-ups will occur at study midpoint and completion (3 and 6 weeks post-randomization,~     respectively), and at 4 weeks post-discharge. Assessments will focus on drug craving, mood,~     stress, motivation/self-efficacy, and physical health and well being. The investigators~     hypothesize that women in the BI group will complete more treadmill sessions and spend more~     time treadmill walking than those in the C group. As a Stage 1b therapy development RCT,~     study data will be used for effect size estimation in preparation for Stage 2 RCT. This~     dissertation proposal will provide benchmark data on the utility of BI for promoting physical~     activity. Further, it will promote exercise compliance, allowing scientists to better~     evaluate potential benefits of physical activity on treatment outcomes in women with SUDs.~   "
174299|NCT01283620|"~     The purpose of this study is to examine the effectiveness and feasibility of a modified~     constraint induced movement therapy (mCIMT) intervention on upper limb function in two groups~     of patients acutely post-stroke; 1) an experimental group that will participate in a 10 week~     mCIMT intervention designed to improve upper limb function, in addition to usual care, and 2)~     a control group that will participate in a program of usual care consisting of a~     rehabilitation intervention for the affected upper limb that is dose-matched to the~     experimental group.~   "
174300|NCT01283607|"~     Yearly, 15,000 Dutch in vitro fertilization (IVF) cycles are performed for subfertility with~     a pregnancy rate of 26%. A failed cycle has great emotional impact; 20-25% of the women has~     relevant forms of depression/anxiety even after 6 months. For such maladjustment a risk~     profile has been identified and translated into a screening tool. Identification of women at~     risk enables a timely and tailored (individual's needs) cognitive behavioral therapy (CBT),~     which reduces more serious maladjustment and corresponding costs.~      Aim: To investigate the effectiveness of an e-health CBT (digital coaching, Digicoach) in~     women ongoing IVF and having been screened at risk.~      Design: A single-centered randomised controlled trial comparing Digicoach (intervention) with~     standard care (control).~      Digicoach: an e-health CBT with 4-12 weekly sessions starting before an IVF cycle, following~     a woman's IVF course and covering in modules the main problems: depressed mood, anxiety,~     strong focus on child wish and acceptance.~      Main outcome measures: anxiety and depression occurrence rate 3 weeks after an unsuccessful~     IVF cycle. Secondary outcome measures: 1. (para)medical consumption, 2. quality of life, 3.~     productivity loss and 4. IVF outcome. Data are collected by questionnaires, diaries, medical~     record audit and page view registrations.~      Process evaluation: Individual's use (e.g. module progress, completion rate), experiences,~     (e.g. satisfaction and usability) and potential barriers for implementation are evaluated.~      Economic evaluation: studied during the Digicoach exposures from a societal perspective.~     Incremental costs (costs/%avoidance of depression/anxiety) are determined by comparing both~     study groups.~      Power/data analysis: To detect a 29% difference in the depression/anxiety occurrence rates~     (alfa=0.05 and beta=0.80) 58 unpregnant IVF women are evaluated.~   "
174301|NCT01283594|"~     The purpose of this research study is to test the effect of SYN115 compared to placebo (a~     sugar pill that looks like SYN115 but does not include active drug) on movement during the~     on and off states as well as other symptoms that some patients with Parkinson's disease~     experience. This study will also look at whether or not patients with Parkinson's disease~     experience side-effects with SYN115.~   "
174302|NCT01283581|"~     The purpose of this study is to compare clinical response to the measurement techniques of~     several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial~     Skin and Skin Structure Infections) clinical trials~   "
174303|NCT01283568|"~     GAMALINE is already register for PMS and HIPERICIN as antidepressive drug. Both plant~     extracts. The investigators will try the mixture and see if the vasomotor symptoms will~     disappear. The investigators expect that together all symptoms will be covered better than~     Gamaline alone. The investigators will run for 180 days measuring at T0, T1 and T6 (starting~     point, 30 days and 180 days).~   "
174304|NCT01283555|"~     The primary objective of this study is to compare the effect of two vaginal applicators,~     delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the~     external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily~     use.~      The secondary objectives are to:~        1. Evaluate and compare the dosing accuracy and precision of the user-filled applicator and~          pre-filled applicator with the candidate microbicide, Tenofovir.~        2. Compare the acceptability of the user-filled applicator with the pre-filled applicator.~   "
174305|NCT01283542|"~     This study will assess pasireotide LAR efficacy on patients with non-functioning pituitary~     adenomas concerning tumor growth.~   "
174306|NCT01283529|"~     Pulse induced continuous cardiac output (PiCCO) is an established technology for measurement~     of advanced hemodynamic variables in critically ill patients. PiCCO is approved and designed~     also for use in children, but there is a lack of documentation of reference values in~     children not suffering from a critical illness. The goal of this study is to establish such~     values.~   "
174307|NCT01283516|"~     This study will assess the safety and efficacy of LDK378 in adult patients with genetic~     abnormalities in anaplastic lymphoma kinase (ALK)~   "
174308|NCT01283503|"~     In this study, BKM120 will be administered to adult patients with advanced solid tumors whose~     disease has progressed despite standard therapy or for whom no standard therapy exists. The~     trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD)~     of BKM120 in Japanese patients.~   "
174309|NCT01283490|"~     The Dental Anesthesia Sonophoresis Device (DASD) is a novel device that is intended to reduce~     the discomfort associated with puncturing the oral mucosa. DASD is a portable,~     battery-powered device that simultaneously generates ultrasonic energy and sonic vibration in~     a small applicator head that can easily reach and adapt to injection sites in the oral~     cavity. The ultrasonic energy provides a sonophoretic effect on the oral mucosa, generating~     micro channels through the lipids between the keratinized cells that make up the stratum~     corneum. Once the benzocaine has permeated the stratum corneum, it is quickly absorbed into~     the soft tissue desensitizing the area and reducing the perception of pain caused by the~     trauma of puncturing soft tissue. Methods: A split-mouth model using 50 healthy subjects from~     the ages of 18 to 50 will undergo needle puncture of the maxillary mucobuccal fold at the~     canine eminence. Prior to the injection there will be randomized application of 20%~     Benzocaine with a device which is a modified battery operated tooth brush that in appearance~     and sound is similar to the DASD which only produces sonic vibration which will be known as~     (SV) or 20% benzocaine with application of the DASD device, that produces ultrasonic as well~     as sonic vibration. Subjects will rate their pain according to the Visual Analog Scale~     (VAS).The purpose of this study is to evaluate whether sonophoresis applied using the DASD~     will eliminate the pain associated with intraoral injections within one minute of~     application.~      Null Hypothesis (Ho): There is no difference in the perception of pain when the DASD is used~     compared to topical anesthetic applied with sonic vibration.~      The Alternative Hypothesis (Ha): There is a difference in pain perception when the DASD is~     used for application of topical anesthetic compared to topical anesthetic applied with sonic~     vibration.~   "
174310|NCT01283477|"~     Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects~     such as itch (pruritis) and nausea & vomiting are common and have been shown to be the most~     common cause for dissatisfaction. The incidence of pruritis is 74% even with current~     available medications. Acupuncture has been shown to be effective for morphine related side~     effects but has not been evaluated for prophylaxis of itch in pregnant population.~      PRIMARY OBJECTIVE:~      Acupuncture at LI 11 reduces the incidence of pruritis after elective caesarean section under~     spinal with intrathecal morphine~   "
174311|NCT01283464|"~     The purpose of this study is to assess the comparative efficacy of retinol 1.0% and tretinoin~     0.02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe~     photodamage. Our hypothesis is that both products will be of comparable benefit.~   "
174347|NCT01282996|"~     The purpose of this study is to compare the influence of a lung protective ventilation with~     conventional ventilation on postoperative complications following major abdominal surgery.~   "
174312|NCT01283451|"~     Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring~     tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS).~     Placement of these sensor pads on the surface of the skin must be such that light penetrates~     the intended compartment without inadvertently obtaining measurements of an adjacent~     compartment. The objective of this study is to examine whether the NIRS measurements of each~     compartment truly represent the tissue perfusion of the intended compartment, as indicated by~     the predictable decrease in muscle oxygenation of a given compartment in response to muscle~     fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated~     compartment will significantly decrease following muscle stimulation, indicating that the~     intended muscle compartment was successfully isolated. Additionally, the investigators~     hypothesize that NIRS values of unstimulated muscle compartments will not change from~     baseline.~   "
174313|NCT01283438|"~     A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction~     with limited discectomy, compared to limited discectomy alone, with regard to preventing~     reherniation and the recurrence of pain or dysfunction.~   "
174314|NCT01283425|"~     The study is an open-label, randomized, two-period crossover study. Up to one hundred and~     twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm~     insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed~     Consent will be enrolled in the study. The aim of the study is to examine the safety of the~     InsuPatch device in a home use setting. Mild Hypoglycemia,hyperglycemia and Adverse events~     will be compared between two phases of the study : 3 months with the use of the device and 3~     months without the use of the device.~   "
174315|NCT01283412|"~     Postoperative agitation (hyperactive delirium) is common following major surgery(incidence~     was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate~     when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine~     is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative~     application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for~     reducing of early postoperative delirium and increase postoperative quality of recovery~     within 24 postoperative hours.~   "
174316|NCT01283399|"~     This observational study will assess the efficacy and safety of combination of rituximab~     (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA)~     who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in~     routine clinical practice. Data will be collected from participants for 12 months after the~     first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.~   "
174317|NCT01283386|"~     This multi-center, randomized study will compare the efficacy and safety of MabThera~     (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil~     in patients with previously untreated B-cell chronic lymphocytic leukemia and unfavourable~     somatic status. Patients will be randomized to receive Mabthera (375 mg/m2 intravenously [iv]~     Day 1 of Cycle 1, 500 mg/m2 iv Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 iv or 32~     mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 iv or orally Days 1-3) or with~     chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study~     treatment is 24 weeks.~   "
174318|NCT01283373|"~     This is a Phase I, multicenter, open-label, dose-escalation study of DSTP3086S administered~     as a single agent by intravenous (IV) infusion to patients with metastatic~     Castration-Resistant Prostate Cancer (CRPC).~   "
174319|NCT01283360|"~     After completing a screening evaluation, 280 eligible participants, including 40 sex workers,~     will be enrolled into Stage 1A of the study during which they will undergo a baseline medical~     evaluation for both history and presence of STIs and anorectal health pathologies or~     injuries, as well as a detailed Web-based baseline behavioral assessment. The first 140~     eligible participants, including 20 sex workers, reporting at least one occasion of~     unprotected RAI in the previous 3 months will be invited to enroll into Stage 1B. In Stage 1B~     participants will apply the universal placebo gel (HEC) rectally prior to each episode of RAI~     over a 3-month period, reporting each use via a phone reporting system; they will complete a~     Web-based questionnaire and take part in a video teleconference at the end of the 3 months.~     The first 24 eligible participants completing Stage 1B will be invited to enroll in Stage 2.~     The subset of sex workers who took part in Stages 1A and 1B will terminate participation at~     the end of 1B. Eligible participants will be randomized to receive either tenofovir 1% gel or~     HEC placebo gel as part of Stage 2, the Phase 1 safety study. Following a baseline visit,~     participants will return to the clinic, where a single dose of the study gel will be~     administered. Within approximately 30 minutes, rectal swab and rectal biopsy specimens will~     be obtained via anoscopy. After a one-week recovery period participants will return to the~     clinic for assessment. If no significant adverse events (AEs) are reported they will begin to~     self-administer once-daily outpatient doses of the study gel for 7 days, after which they~     will return to the clinic for evaluation and specimen collection.~   "
174320|NCT01283347|"~     The primary objective of this protocol is to analyze the sensitivity and specificity of~     18F-DTBZ PET to the differential diagnosis of Parkinson's Disease (PD) and normality.~     Secondary, the investigators will analyze the correlation between the 18F-DTBZ binding and~     the severity of disease of PD and the role of 18F-DTBZ PET in the monitoring disease~     severity.~   "
174321|NCT01283334|"~     The purpose of this study is to test the drug RAD001 in combination with other chemotherapy~     drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination~     before, it is not clear which dose will be best when used in combination.~      The investigators will test the safety of RAD001 in combination with Carboplatin and~     Cetuximab and see what effects (good and/or bad) it has on your cancer, and find the highest~     dose of RAD001 that can be given without causing bad side effects. The doses of Carboplatin~     and Cetuximab will not be varied as both these drugs are considered to be part of the current~     standard of care for patients with your condition.~   "
174330|NCT01283217|"~     Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but~     it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase~     I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for~     advanced gastric cancer achieved response rates of 46~56% and a median survival time of~     14.0~14.3 months.~      Based upon this background, the aim of this study is to detect a significant increase in 3~     year DFS of disease for the test group (DS) relative to the Control group (SP).~   "
174322|NCT01283321|"~     Heart surgery involving valve replacement often involves the use of the heart-lung machine~     for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet~     transfusion has been the primary therapy to treat bleeding after this type of procedure. More~     recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was~     shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The~     objective of this trial is to demonstrate the clinical equivalency and economic utility of~     using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in~     patients in lieu of platelet transfusion.~      Purified fibrinogen concentrate has been approved by FDA, and it has been used for the~     treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes~     (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be associated~     with volume overload, bacterial/viral infection, immunological effects and excess blood~     clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma~     allowing for low volume infusion. Several viral inactivation/reduction steps are used to~     prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood~     cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare.~     Although platelet transfusion is widely used after heart surgery, there has been no~     randomized study to endorse this practice. In this study, patients undergoing heart valve~     replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen~     concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if~     there is evidence of significant microvascular bleeding. Fifteen minutes after the initial~     treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be~     treated with blood transfusion per institutional standard of care.~      The primary endpoints for this study are the hemostatic condition of the surgical field and~     24-hour total of blood product transfusion.~   "
174323|NCT01283308|"~     People from the Indian subcontinent are more likely to get diabetes, even at younger ages.~     The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial~     if a culturally specific, community-based lifestyle and metformin (for individuals who do not~     respond to lifestyle change alone) intervention for men and women living in Chennai, India~     can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are~     programs that seek to prevent disease by promoting changes in health behaviors, improved~     diet, increased physical activity, and weight loss. The results of this program will be used~     to make policy and public health recommendations, which will result in broader diabetes~     prevention efforts. The research team hypothesizes that this program will result in~     improvements in health (diabetes prevention, weight loss, and improvements in other markers~     of chronic disease) for intervention participants compared to participants in the control arm~     of the study.~   "
174324|NCT01283295|"~     The purpose of this study to develop a well-characterized library of blood, biopsy tissue,~     and urine samples from transplant patients. Subjects without transplants will also be~     enrolled for comparison. Samples will be used to study the characteristics of patients~     undergoing transplantation that influence their response to transplant therapies and their~     reactions to drugs used in transplantation. This knowledge is important as it helps~     physicians design new drugs and tailor transplant therapies to the individual thereby~     reducing the side effects. In this study, people will be asked to donate blood, biopsy tissue~     and urine. Donation of these samples will not influence patients' treatments. These samples~     will be tested using a variety of biological tests to better understand how immunosuppressive~     drugs change the various components of the immune system. The tests will be for research~     only; no changes in an individual's treatment will be based on the results of tests performed~     in this study. If there is extra sample, the sample will be stored for use in other testing~     at a later date. The ultimate goal is find the right combination of medications for each~     individual patient while keeping their new organ working well. This study is a first step in~     that direction by perfecting tests used to characterize a patient's immune system~   "
174325|NCT01283282|"~     The investigators would like to investigate whether clopidogrel will help lower the level of~     harmful markers in patients with coronary artery disease, and at the same time will help~     increase the cells that are useful in repairing the damaged blood vessels. The investigators~     will give half of the patients clopidogrel and the other half a sugar pill, placebo, and~     check the levels of these markers and helpful cells in each group. At the same time the~     investigators will check how well these patient's blood vessels work using ultrasound imaging~     of the forearm to see how blood vessels relax and tonometry to see how stiff the patient's~     blood vessels are. After 6 weeks of drug therapy, the patients will switch to the other drug~     and these same tests will be performed after an additional 6 weeks of therapy. The drug taken~     by the patient will not be known to the patient or the researchers. The patients will~     continue on their prescribed medical therapy during the duration of the 12 week study.~   "
174326|NCT01283269|"~     Mild Cognitive Impairment (MCI) is often an early manifestation of Alzheimer's disease (AD).~     The ability to identify MCI has led to hope that health prevention models might work in AD as~     they have in cancer and heart disease. Interventions which help sustain functioning in MCI~     may delay progression to a clinical AD diagnosis. To date, interventions aimed at maintaining~     functioning in MCI have been pharmacologic in nature. The efficacy of these medications in~     MCI is controversial, and those with MCI are also often interested in other activities they~     can do to manage their memory loss.~      When an individual is noted to have memory difficulties or MCI, a recommendation is often~     given for the patient to begin taking notes/using a calendar to help with memory or do~     cognitively stimulating activities. However, there is currently little instruction about~     how/what specific activities one should do and how effective they may be. The overall goal of~     this pilot project is to refine delivery of the Memory Support System (MSS)as a formal~     compensatory program for memory loss in MCI. Enrollment and retention data will be carefully~     investigated across 6 week and 10 day intervention groups. The investigators will compare~     participant adherence to the notebook training in the 6 week and 10 day versions of the~     intervention to the computer activity group. The investigators will also collect data on the~     clinical efficacy of the notebook and computer training to investigate if these interventions~     can sustain/improve functional level. Long term goals for this project also include delaying~     relocation for persons with MCI who may progress to dementia, thus not only improving the~     lives of these individuals, but also reducing health care expenditures.~      The investigators will recruit a total of 60 individuals with MCI and their 60 program~     partners across all three sites for this project. At least 16 of these pairs will be~     recruited at Emory University (maximum of 20 pairs/40 individuals anticipated). The~     investigators will randomly assign participants to the 6 week notebook or computer training~     or 10 day notebook or computer training. All participants will also receive patient education~     regarding MCI and cognitive health.~      Subsequent compliance with the MSS will be examined at 3 months, 6 months, and then annually~     following the intervention. Outcome measures will provide a detailed, multi-modal assessment~     of participants' functional level, overall cognitive functioning, mood, and self-efficacy, as~     well as caregiver burden and mood.~   "
174327|NCT01283256|"~     The purpose of this study is to evaluate the safety and efficacy of zonisamide in the~     treatment of adult patients with partial, generalized or combined seizures.~   "
174328|NCT01283243|"~     This is a prospective cohort single center study for assessment of normal value of acoustic~     radiation force impulse elastography and fibroscan in HIV patients without abnormal liver~     function and chronic liver disease.~   "
174329|NCT01283230|"~     This is a prospective cohort Study for evaluation of liver fibrosis staging with acoustic~     radiation force impulse elastography in patients with chronic liver disease and healthy~     liver/kidney donors.~   "
174652|NCT01278992|"~     The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when~     compared to placebo in nurses involved in shift work.~   "
174333|NCT01283178|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans~     and treatment-planning systems may help in planning radiation therapy. Drugs used in~     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving radiation therapy~     together with cisplatin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated~     image guided adaptive radiation therapy when given together with cisplatin in treating~     patients with locally advanced head and neck squamous cell cancer~   "
174334|NCT01283165|"~     The main objective of the project was to determine the effect of integrated school based~     deworming and health education on prevalence and morbidity due to co-infection infection with~     schistosomiasis, STHs and malaria among primary school age children living in rural and~     farming areas in Zimbabwe~      There is need for regular school based de-worming and health education programs for the~     helminths-Plasmodium co-infections in primary schoolchildren living in rural and commercial~     farming areas in Zimbabwe~   "
174335|NCT01283152|"~     This study is being done to find out if the laxative polyethylene glycol (also known as~     GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver~     disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In~     this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more~     effective than lactulose on neurocognition (memory and thinking skills) and determine if it~     decreases the hospital stay.~   "
174336|NCT01283139|"~     To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with~     moderately to severely active Systemic Lupus Erythematosus (SLE).~   "
174337|NCT01283126|"~     The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy~     individuals and how well changes in (interstitial) tissue glucose levels correlate with~     changes in cognitive function as compared to blood glucose levels.~   "
174338|NCT01283113|"~     The main aim of this study is to compare 2 different measurements of visceral fat that can be~     easily used in clinical practice (waist circumference versus bioelectric impedance) in~     relation to known risk factors of coronary artery disease in a large cohort of patients with~     type 2 diabetes and with a BMI range between 20-45 kg/m2~   "
174339|NCT01283100|"~     This is a single-center, open-label, three-period, fixed-sequence cross over study in healthy~     adult subjects. A total of approximately 16 healthy subjects will be enrolled to provide data~     from 12 evaluable subjects. Subjects will have a screening visit within 30 days prior to the~     first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the~     last dose of study drug. There will be a washout period between Period 1 and Period 2 but no~     washout between Period 2 and Period 3. Day 1 of Period 3 will be the day after Day 5 of~     Period 2.~   "
174340|NCT01283087|"~     The purpose of this study is to find out whether patients receiving spinal anesthesia~     containing lidocaine and sufentanil get transient neurological symptoms.~   "
174341|NCT01283074|"~     This observational, multi-center, open-label study will evaluate the prognostic factors of~     long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with~     HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.~   "
174342|NCT01283061|"~     The objective of this study was to compare the relative bioavailability of zafirlukast~     tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy,~     adult, human, subjects under fasting conditions and to monitor safety of subjects.~   "
174343|NCT01283048|"~     BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in~     laboratory experiments and information from those research studies suggests that this drug~     may help to slow the growth of renal cancer cells. In this research study, the investigators~     are testing the safety to BKM-120 at different dose levels. The investigators will also be~     studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of~     kidney cancer.~   "
174344|NCT01283035|"~     Akt inhibitor MK2206 is a drug that may stop cancer cells from growing by blocking a protein~     called protein kinase B (AKT) inside the cell. AKT interacts with other proteins in the cell~     that are part of the P13K/AKT pathway, a pathway that is know to play a role in the growth of~     cancer cells. Mutations in P13K or in AKT, or changes in another protein called phosphatase~     and tensin homolog (PTEN) in this pathway can lead it to become more active than is normal.~     This study investigates how effective MK-2206 is in treating ovarian, fallopian tube, or~     primary peritoneal cancer where there are mutations in P13K or AKT or low levels of PTEN.~   "
174345|NCT01283022|"~     The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for~     the MVI 200 in women requiring cervical ripening and induction of labor.~   "
174346|NCT01283009|"~     The goal of the study is to determine whether providing early treatment with a glucocorticoid~     drug, called methylprednisolone, will improve survival in critically ill patients with severe~     community-acquired pneumonia (CAP). Pneumonia develops when bacteria and other agents invade~     the lungs. The body's immune system creates a response to produce inflammation to kill the~     bacteria. A moderate amount of inflammation is beneficial. But, in patients sick enough to be~     admitted to the ICU, inflammation is frequently out of control. When the body cannot regulate~     inflammation vital organs (brain, heart, lung, kidney, liver) may be damaged, contributing to~     death or residual organ damage for those who survive. Glucocorticoids help reduce~     inflammation. Recent studies have shown that when the body is unable to produce sufficient~     amounts of glucocorticoids, inflammation can get out of control. Under these circumstances,~     glucocorticoids given in small doses may help aid the body's ability to reduce inflammation~     and improve recovery. In a small preliminary trial, glucocorticoid treatment, in addition to~     standard antibiotic treatment, sped up recovery from pneumonia. It also decreased the length~     of hospital stay, and increased survival. This Cooperative Studies Program study will be the~     first large-scale, prospective, randomized clinical trial evaluating whether or not this~     treatment improves recovery.~      In this study, at each site, patients with severe CAP will be assigned to one of two~     treatment groups. One group will receive methylprednisolone and the other will receive a~     placebo (an inert substance that will look like the drug). The investigators have chosen a~     total duration of treatment of 20 days (7 days full dose followed by slow reduction over 13~     days) to prevent relapse of inflammation and allow the body to recover its own ability to~     produce glucocorticoid. All patients will also receive standardized management of CAP in~     accordance with current practice guidelines. The study will take into consideration when~     assigning the treatment each participating site, and whether or not the patient requires~     mechanical ventilation at the time of assignment. Patients will be followed clinically for~     180 days. The primary outcome is all cause 60-day mortality. Secondary outcomes are (1)~     in-hospital morbidity-mortality, including ventilator-free days, multiorgan dysfunction~     syndrome (MODS)-free days, duration of ICU and hospital stay, and hospital discharge; and (2)~     posthospital discharge morbidity-mortality, including cardiovascular complications,~     functional and general health status in the first 180 days, rehospitalization, and mortality~     at 1 year. Serial blood samples will also be collected and stored for future translational~     research relating longitudinal inflammation markers to clinical outcomes.~      This study will advance knowledge on the relationship between inflammation and long-term~     outcome in severe CAP.~   "
174348|NCT01282983|"~     Dietary fiber (commonly called bulk or roughage) is the edible nondigestible component of~     carbohydrate and lignin naturally found in plant food; however, bacteria in the lower gut may~     metabolize part of it. Epidemiological studies have found that fiber intake in the population~     is below the suggested recommendations. The beneficial effects of the fibers in human health~     are recognized. The regular intake of dietary fiber has an important role in the intestinal~     function increasing the intestinal fecal and reducing the transit time along the intestine;~     collaborates with the LDL-cholesterol plasmatic reduction by increasing fecal excretion of~     cholesterol and bile acids, decreases postprandial glucose in healthy, diabetics and insulin~     resistant people, reduces the risk for developing certain cancers, promotes satiety, helps~     with weight loss, and exerts immunomodulatory effect. However, fiber intake may be associated~     with adverse effects such as flatulence, bloating, cramps, and daily consumption of orange~     juice to bring digestive problems associated with acidity and heartburn, epigastric burning.~     Then it becomes of interest to study the tolerance of a new orange juice product fortified~     with mixed fibers (fructooligosaccharides, resistant dextrin, polydextrose and lactulose).~   "
174349|NCT01282970|"~     The objective of this study is to investigate safety, tolerability, pharmacokinetics and~     pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days~   "
174350|NCT01282957|"~     The primary objective of the study is to assess the effect of financial incentives on the use~     of home health monitoring devices among high-risk patients. In addition, there are three~     secondary objectives: (1) obtain preliminary evidence regarding whether the monetary value of~     incentives has a differential effect on the use of home health monitoring devices; (2)~     identify potential barriers that prohibit regular use of home-based health devices using~     qualitative data; and (3) assess the usability of a newly developed web portal and its~     feasibility for future randomized clinical trials aimed at changing health-related behaviors.~   "
174351|NCT01282944|"~     The goal of this pilot randomized controlled trial is to evaluate whether financial~     incentives and peer networks delivered through a novel computer platform utilizing a digital~     pedometer-internet interface can effectively encourage sustained increases in walking among~     older adults.~   "
174352|NCT01282931|"~     The goal of the study is to understand the meaning of progression-free survival for women~     with metastatic breast cancer and to use this understanding to create and distribute a new~     questionnaire to assess the effect progression has on a woman's functioning and well-being.~   "
174353|NCT01282918|"~     The purpose of the NORDIC ICD study is to evaluate whether ICD implantation without~     intra-operative DF testing is non-inferior to ICD implantation with intra-operative DF~     testing regarding the efficacy of the first ICD shock for the treatment of true spontaneous~     ventricular tachyarrhythmias.~   "
174354|NCT01282905|"~     The purpose of this study is to evaluate the relation between sulphide detoxification and~     butyrate metabolism at the level of gene expression and enzyme activity in ulcerative colitis~     patients and healthy controls.~   "
174355|NCT01282892|"~     Visceral fat or peri-omental fat is increasingly associated with metabolic syndrome, a~     condition carrying a high risk of coronary artery disease. The independent role of Visceral~     Fat in cardiovascular risk remains unclear.~      Patients with excess of visceral fat and NAFLD patients will have higher prevalence of~     coronary atherosclerosis plaques independently by metabolic syndrome diagnosis. Suggesting~     that the presence of visceral fat and/or fatty liver will be considered an important~     condition to optimize the cardiovascular risk stratification~   "
174356|NCT01282879|"~     Antifungal prophylaxis should be used in patients being treated with glucocorticoids for~     graft-versus-host disease (GVHD) following allogeneic hematopoietic stem-cell transplantation~     (HSCT). Although fluconazole has been widely used as an antifungal prophylactic agent after~     allogeneic HSCT, fluconazole prophlaxis only shows a limited protective role against IFIs, is~     not effective against invasive aspergillosis. In addition, NCCN guideline of the prevention~     and treatment of cancer-related infections recommends antifungal prophylaxis in patients with~     significant GVHD until resolution of GVHD using Posaconazole, Voriconazole, Echinocandin, or~     Amphotericin B. However, under the National Health Insurance System, none of the drug can be~     given prophylactically except itraconazole oral solution against IFIs. Itraconazole oral~     solution shows excellent bioavailability and good efficacy against aspergillus and~     fluconazole resistant candida infection.Based on these findings, we will perform prospective~     multicenter study evaluating the efficacy, safety and long-term outcomes of itraconazole oral~     solution prophylaxis against IFIs in patients treated with systemic corticosteroids for GVHD~     after allogeneic HSCT.~   "
174357|NCT01282866|"~     The objective of this clinical study is to verify hair count reduction, associated~     comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed~     (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated~     that the larger treatment size of the HS handpiece will result in faster treatment of larger~     areas; and that the lower energy levels will result in greater comfort.~   "
174358|NCT01282853|"~     Rapid urease test (RUT) is the most commonly used biopsy-based method to diagnose~     Helicobacter pylori (Hp) infection because of its simple, rapid and accurate characters.~     However, its sensitivity was reported to decrease during ulcer bleeding recently. So it is an~     important issue to avoid a false negative test in these patients. Siddique et al reported~     that the sensitivity of RUT could be increased when the biopsy number increased from 1 to 4.~     Other studies demonstrated that additional biopsy from gastric body would increased the~     sensitivity of RUT in patients with ulcer bleeding. Therefore, we design this study to see if~     increased number of biopsy or different location of biopsy could increase sensitivity of RUT~     in patients with gastroduodenal ulcer bleeding.~      After receiving explanation and giving consent, these patients with gastric or duodenal ulcer~     bleeding diagnosed after endoscopic examination will be enrolled. Those who are unstable,~     have received antibiotic or continuous proton pump inhibitor treatment within 4 weeks, or are~     contraindicated for endoscopic biopsy will be excluded. We will take 1 piece, 4 pieces of~     biopsy samples from prepyloric antrum and 1 piece from gastric body with standard biopsy~     forceps from the patients after they agree for RUT test. Then, we put these samples into 3~     separate RUT kits respectively. We use 13C-UBT as gold standard for diagnosis of Hp~     infection. It is scheduled: (1) if the condition of this patient is not suitable for breath~     test just after endoscopic examination, 13C-UBT will be performed within 2 days,(2)~     otherwise, it will be performed 1 hour after examination. We plan to enroll 100 patients for~     this study. We will apply McNamer's test to examine the difference of RUT sensitivity of~     different biopsy number. For the RUT sensitivity from different locations, we use kappa~     statistic method to analyze their consistency.~   "
174406|NCT01282229|"~     The purpose of this study is to compare the Laser Assisted New Attachment Procedure (LANAP~     protocol) using the Free-running (FR) Pulsed Neodimium: Yttrium aluminium garnet (Nd:YAG)~     laser to Scaling and Root Planing (SRP) alone, Modified Widman Flap (MFF) surgery, and~     Coronal Debridement (CD) alone with respect to periodontal clinical attachment level gain.~   "
174359|NCT01282840|"~     Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the~     etiology of OAB is complicated and unclear in many aspects. Bladder wall thickness had been~     reported to be strongly associated with OAB, but its use as a screening tool remains~     controversial. Besides, few studies reported patterns of sexual dysfunction in female~     patients with lower urinary tract symptoms (LUTS). Therefore the aims of our study were to~     analyze the bladder wall blood perfusion pattern in female LUTS patients, the association of~     between the bladder wall blood perfusion pattern and the efficacy of anti-muscarinic~     treatment for female OAB, and the patterns of sexual dysfunction in the female LUTS patients.~   "
174360|NCT01282827|"~     Non-invasive brain stimulation can increase cortical excitability in the visual system, but~     it is not known if this is of clinical value. The investigators now assessed if repetitive,~     transcranial alternating current stimulation (rtACS) can improve visual field size in~     patients with optic nerve damage. The investigators hypothesized that rtACS would improve~     visual functions with the defective visual field sectors of the visual field (primary outcome~     measure).~   "
174361|NCT01282814|"~     The objective of this study was to compare the rate and extent of absorption of venlafaxine~     hydrochloride 150 mg capsules (test) versus Effexor® XR (reference) administered as the~     content of 1 x 150 mg extended-release capsule mixed with applesauce under fasting~     conditions.~   "
174362|NCT01282801|"~     The objective of this study was to compare the rate and extent of absorption of venlafaxine~     hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference)~     administered as 1 x 150 mg extended-release capsule under fed conditions.~   "
174363|NCT01282788|"~     Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer~     from stunting of linear growth by 12 months of age. Stunting presumably results from breast~     milk supplementation after 6 months of age with complementary foods (CF) that provide~     inadequate protein and micro-nutrients. Although supplementation with selected~     micro-nutrients may avoid certain deficiency states, CF with animal source foods may be~     necessary to avoid stunting. Meat is not readily available in many Central African countries.~     However caterpillars, which are locally available and abundant, are a common staple in adult~     diets and may be a suitable substitute for animal source proteins in CF. The investigators~     developed a cereal made from dried caterpillars that has a nutrient content that appears to~     be ideal for CF and demonstrated maternal and infant acceptability. This study will~     investigate the efficacy in prevention of stunting of growth resulting from inadequate~     complementary foods.~      A sub-study will evaluate the biologic effects of the caterpillar cereal to determine whether~     caterpillar cereal prevents iron deficiency anemia, reduces the incidence of~     neurodevelopmental impairment or infectious diseases.~   "
174364|NCT01282775|"~     CDC WAY to Health is a three year, group-randomized weight loss intervention study where~     approximately 1020 overweight/obese employees nested within 17 community colleges are~     randomly assigned to receive one of three promising, state-of-the-art, theory-linked~     interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment~     (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and~     intervention; employee is the unit of analysis. Follow-up weigh-in assessments are conducted~     at 3, 6, and 12 months.~   "
174365|NCT01282762|"~     The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and~     Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in~     a cohort of chronic kidney disease (CKD) patients over time.~   "
174366|NCT01282749|"~     The purpose of the SisterTalk Hartford study was to assess whether a theoretically- and~     scientifically-based, culturally acceptable weight loss program could be effectively~     translated into a faith-based program and subsequently delivered in the church to help~     African-American women lose weight.~   "
174367|NCT01282736|"~     The proposed study will employ a randomized design to evaluate the efficacy of two~     group-based guided self-help treatments: Integrative Response Therapy (IRT) and Cognitive~     Behavior Therapy Guided Self-Help, a treatment of known efficacy, in group-format (CBT-GSHg)~     in the treatment of Binge Eating Disorder (BED), and explore (1) moderators and mediators of~     treatment, (2) the relative cost-effectiveness of the two treatments, and (3) between group~     differences on secondary measures (e.g., eating disorder and general psychopathology).~   "
174368|NCT01282723|"~     This multi-reader multi-case study was designed to evaluate the performance of SureCALL® EMG~     Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the~     performance of an Intrauterine Pressure Catheter device (IUPC) as the gold standard.~   "
174369|NCT01282710|"~     This measurement study was designed to evaluate the performance of SureCALL® EMG Labor~     Monitor® (SureCALL®) to the predicate Tocodynamometer device (TOCO) using the performance of~     an Intrauterine Pressure Catheter device (IUPC) as the gold standard.~   "
174370|NCT01282697|"~     Therapeutic solutions to treat solid tumors that are resistant to conventional treatments are~     now limited. Laboratory data in animals (on pediatric tumors such as brain tumors, sarcomas~     and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha inhibitor) and~     rapamycin (mTOR inhibitor) allowed to block development of blood vessels in the tumor and~     could, in some cases, stop its progression. This drug combination has already been tested in~     adult patients with refractory tumors and seems to give encouraging results with~     stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known when~     these drugs are administered separately and in a context different from that of refractory~     tumors. RAPIRI is a phase I clinical trial whose principal objectives are to determine the~     maximum dose at which these two molecules may be administered and to assess the safety of~     this new combination of drugs.~   "
174371|NCT01282684|"~     The purpose of this study is to study the safety and tolerability of a single dose of PLX5622~     in healthy, adult human volunteers. This will be the first time PLX5622 has been taken by~     humans.~   "
174372|NCT01282671|"~     Hypothesis: Deep breathing exercises performed during the first two months after cardiac~     surgery, will improve pulmonary function and patient-perceived quality of recovery.~      Specific aim: To evaluate the effectiveness of breathing exercises performed with a~     mechanical device for positive expiratory pressure during the first two months after cardiac~     surgery compared to a control group performing no breathing exercises.~      Design: A prospective, randomized, controlled two-center study.~   "
174653|NCT01278979|"~     This study aims to compare different midwife practitioners assessments of perineal tears.~   "
174373|NCT01282658|"~     Irinotecan (CPT-11) is now widely used as the first-line chemotherapy for mCRC. There were 4~     key enzymes for CPT-11 metabolizing, CYP3A4, UDP-glucuronosyltransferase,~     carboxylesterase(CES), and ATP-binding cassette (ABC) transporters. Genetic variations of~     those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this~     study is to figure out the correlation between the genetic polymorphism and the drug~     response.~   "
174374|NCT01282645|"~     The primary objective of this retrospective study is to evaluate the percentage of patients~     with device related adverse events (infection, rejection, dislocation, fracture of the~     implant) in the first 24 months after implantation.~   "
174375|NCT01282632|"~     Atypical neuroleptics may have antidepressant qualities in bipolar depression and in unipolar~     depression. Some data support the use of both Risperidone and Olanzapine, but there are no~     direct comparisons of their relative efficacy and tolerability in treatment resistant~     depression. The current study was designed as a pilot study to examine efficacy and~     tolerability of Olanzapine vs. Risperidone add on to a failed serotonin re-uptake inhibitor~     (SSRI) in depression.~   "
174376|NCT01282619|"~     The main purpose of this study is to evaluate the safety and efficacy of Huperzine A~     sustained release tablets in patients with mild to moderate Alzheimer's Disease.~   "
174377|NCT01282606|"~     The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation~     patients.~   "
174378|NCT01282593|"~     Down regulation of CD9 in TEL/AML1-positive ALL is addressed in motility assays to explore~     its role in B-ALL pathogenesis and its potential implication in relapses (and prognosis).~   "
174379|NCT01282580|"~     Research studies show that the type of fat in the diet may affect breast cancer risk. Fish~     oil and fish contain increased amounts of omega 3 fatty acids which appear to stop or slow~     down the growth and development of breast cancer cells in laboratory studies of mice and~     breast cancer cells. The use of omega 3 fatty acids to reduce the risk of breast cancer~     development in humans has not been adequately studied. Eating fish or taking fish oil may~     increase the amount of omega 3 in the breast, which may lower one's risk of breast cancer~     development.~      Persons in this study with do one of the following: (1) take two capsules daily of omega 3~     fatty acid supplements, or (2) eat several servings of canned salmon / tuna per week for a~     total of three months. Amounts of omega 3 fatty acids in the body's tissues will be measured~     by blood tests and a small sample of breast fat as obtained by a fine needle aspiration.~      This study is supported by funding from the National Fisheries Institute, Food Innovation~     Center of The Ohio State University, and The Ohio State University Comprehensive Cancer~     Center.~   "
174380|NCT01282567|"~     The Artificial Pancreas Project developed by SUPELEC and the University Hospital of Rennes is~     focused on the evaluation of an original control algorithm that computes appropriate~     subcutaneous insulin infusion in response to continuous glucose measurements The results~     during a 24-hour closed-loop period will be compared with those of the open-loop. The~     implementation of this algorithm named Error Dynamics Shaping (EDS) requires as a preliminary~     a phase of identification of the parameters of the model (insulin pharmacokinetics and effect~     on glucose metabolism) followed by a phase of optimization i.e. a personalized adjustment of~     the damping parameters of EDS.~      The present study aims to formalize this procedure of identification/optimization of the~     parameters of the model and controller EDS. They will be determined in type -1 diabetic~     patients using insulin therapy and under conditions free from disturbances such as those~     generated by the glucidic meals, i.e. during a period of glucidic fast. Three variables will~     determine this procedure: blood glucose, insulin concentration and insulin doses.~   "
174381|NCT01282554|"~     Sport improves quality of life and health, decreasing cardiovascular risks and increasing~     effort tolerance. Chronic renal failure (CRF) induces many clinical and biological~     complications leading to less effort tolerance (strength and endurance). Renal failure~     patients got also many cardiovascular risks : sedentarily lifestyle, hypertension (HTA),~     diabetes, neuropathies, bone disorders, depression and sedentarity due to dialysis sessions.~     Moreover, dialysis sessions three times a week induce the spiral of deconditioning. In order~     to counteract this, sport should be encourage in this specific hemodialysis population.~      The aim of this study is to evaluate electrostimulation program during dialysis sessions for~     3 months. Evaluation will be done using the Test of 6-minute walk (6MWT).~      Secondary aims will be evaluated:~        -  Muscular strength and quadriceps diameter~        -  Equilibrium~        -  Quality of life.~        -  Strength developed during maximal exercise test in a subgroup (patient undergoing~          dialysis in Rennes center, about 40% of the total population)~        -  Nutritional intakes (quantitative and qualitative evaluation)~   "
174382|NCT01282541|"~     Epiphora or excessive tearing is a significant disability for many affected patients~     diminishing their quality of life. There is a growing consensus that injection of Botulinum~     Toxin A (BTX-A) into the lacrimal gland provides relief in patients with hyperlacrimation~     secondary to aberrant regeneration of the 7th nerve, and limited evidence that it might help~     to reduce normal tear production in patients with epiphora from anatomic or functional~     outflow obstructions. BTX-A has been injected both transconjunctivally into the palpebral~     lobe of the lacrimal gland and transcutaneously into the orbital lobe. Both delivery routes~     have been successful in symptom relief with minimal complications. However, the effectiveness~     of transconjunctival versus transcutaneous injections has not been systematically compared.~     Also, whether the incidence of side effects is related to the dosage, concentration, or~     location of injection is unknown and has also not been systematically studied. The~     investigators plan to conduct a randomized clinical trial in patients with functional tearing~     comparing the transcutaneous delivery route of BTX-A to the transconjunctival delivery route~     (the most common route described in the literature). The investigators will also compare the~     side effect profile of each delivery route.~   "
174383|NCT01282528|"~     To evaluate the predictive value of clinical, functional (HAQ), laboratory and US variables~     in relation to disease activity and radiographic outcome in patients with RA who start~     treatment with Remicade at 24 weeks.~   "
174384|NCT01282515|"~     To compare the effect and side effects of photodynamic treatment and traditional topical~     steroid treatment in female genital erosive lichen planus~   "
174654|NCT01278966|"~     The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children~     and adolescents with drug-resistant epilepsy regarding seizure control, and to create a~     protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.~   "
174385|NCT01282502|"~     This study combines midostaurin (PKC412) with radiation and a standard chemotherapy drug call~     5-Fluorouracil (5-FU) for subjects with advanced rectal cancer. Midostaurin is a type of~     kinase inhibitor which works by blocking proteins associated with cancer cell growth.~     Previous studies also suggest that midostaurin may help increase the effectiveness of~     radiation therapy. In this research we are looking for the highest dose of midostaurin that~     can be given safely in combination with standard chemoradiation.~   "
174386|NCT01282489|"~     A basic requirement for every therapeutic procedure is that there be an objective and~     validated method to assess the benefit of the treatment for the patient. Currently, there is~     no acceptable procedure to quantify the benefit obtained from visual prostheses.~      The goal of the proposed research is to evaluate visual tasks and tests that will be given to~     a very large number of volunteers with normal vision who will be using a novel virtual~     prosthesis simulator. This device will simulate the realistic visual information that a~     visual implant can provide and will be used to measure implants in current clinical trials.~   "
174387|NCT01282476|"~     Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by~     blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory~     studies. However, it is not known if it will show the same activity in humans. Panobinostat~     has been given to participants with various types of cancers, including DLBCL, in previous~     research studies. In this study panobinostat will be given with the the antibody rituximab,~     which is FDA approved to be given with chemotherapy in DLBCL.~   "
174388|NCT01282463|"~     This multicenter trial will enroll participants with metastatic transitional cell carcinoma~     of the bladder, urethra, ureter, or renal pelvis who have had disease progression on~     first-line platinum-based chemotherapy regimens. Participants will be enrolled into 1 of 3~     treatment arms: docetaxel; docetaxel and ramucirumab; or docetaxel and IMC-18F1.~   "
174389|NCT01282450|"~     In recent years, it has become clear, that also in non-small cell lung cancer (NSCLC), a~     group of patients with less than 5 distant metastases may experience long-term survival when~     treated radically to all macroscopic cancer sites. Thus has mostly been established for~     individuals with so-called solitary brain metastases and to a lesser extend in solitary~     adrenal gland metastases, but in other metastatic subgroups, the same may be applicable. In a~     prospective survey in the region of the Integral Cancercentre (IKL), we could identify on a~     yearly base 30 patients with NSCLC who could theoretically be amendable for radical treatment~     of all oligo-metastatic locations. We therefore want to perform a prospective study in which~     patients with less than 4 oligo-metastatic sites from a primary NSCLC will be treated~     radically with the aim to improve long-term survival. As many discussion points remain, even~     after thorough discussions with chest physicians, pulmonary surgeons and colleagues from~     diagnostic disciplines, we decided to go for a pragmatic approach, implying that all~     macroscopic disease sites should be treated radically, being defined as surgery with a R0~     resection or in case of an unforeseen R1 resection, followed by radiotherapy, or radiotherapy~     to a biological equivalent of at least 60 Gy in 30 daily fractions. In the same patient, one~     metastatic site may be treated with surgery and another with radical radiotherapy. Systemic~     treatment was not made mandatory, because it was felt that it's role is unclear in patients~     with early stage local cancer and with oligo-metastatic disease.~   "
174390|NCT01282437|"~     For patients with stage III non-small cell lung cancer, which is radically treated, we will~     investigate whether prophylactic cranial irradiation (PCI) should become standard of care to~     prevent brain metastases.~   "
174391|NCT01282424|"~     The purpose of this study is to evaluate the efficacy and safety of idelalisib in patients~     with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to~     rituximab and to alkylating-agent-containing chemotherapy. The primary objective will be to~     assess the overall response rate.~      Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg~     taken twice per day. Treatment with idelalisib can continue in compliant patients as long as~     the study is still ongoing and the patients appear to be benefiting from treatment with~     acceptable safety.~   "
174392|NCT01282411|"~     Ozurdex(TM) has recently been FDA approved for use in macular edema secondary to retinal vein~     occlusion. It remains unclear how quickly the drug works and for how long as the initial~     studies did not have frequent anatomic monitoring. This study will utilize frequent Spectral~     domain OCT imaging to better understand the onset of treatment effectiveness and duration of~     action on the anatomic thickness of the retina, in addition to distinguishing structural~     abnormalities of responders from non-responders.~   "
174393|NCT01282398|"~     The purpose of this study is to determine whether simvastatin is effective in the prevention~     of progression of porta hypertension in compensated cirrhosis patients.~   "
174394|NCT01282385|"~     In the genesis and maintenance of PH associated with liver cirrhosis are two mechanisms that~     act synergistically. The first is an increase in hepatic vascular resistance, due in part to~     the disruption of liver structure inherent cirrhosis, and increased hepatic vascular tone is~     caused by the contraction of perivascular smooth muscle cells, myofibroblasts and hepatic~     stellate cells, which represents about 30% of global intrahepatic resistance and is believed~     to be due to the production Defective nitric oxide (NO). The second mechanism, which~     maintains and exacerbates HTP, is an increase of splanchnic blood flow caused by increased NO~     and other vasodilators at this level~      In this regard, we believe that in patients with compensated liver cirrhosis, with portal~     pressure gradient> 10 mmHg, both acute responders betablockers test as non-responders, the~     association of antifibrotic drugs and / or vasodilators, chronic liver selective May be~     beneficial in the control of portal hypertension~   "
174395|NCT01282372|"~     Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated an~     improvement in work productivity in participants with rheumatic diseases: rheumatoid~     arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Limited data was~     available for the effect of adalimumab treatment on sleep in all three diseases (RA, PsA, and~     AS) and no data was available for the effect of adalimumab treatment on work productivity in~     PsA. This long term Health-Related Quality of Life (HRQL) observational study was conducted~     to evaluate the effect of treatment with adalimumab on work productivity and sleep~     disturbance in Greek participants with moderate to severe rheumatic diseases (RA, PsA, and~     AS).~   "
174396|NCT01282359|"~     The asthma clinical practice guidelines categorize with the highest evidence level the~     effectiveness of educational programs. However, health care professionals not regularly~     applied it. This may contribute to inadequate control of the disease. Consequently, their~     designs and implementation strategies should be reviewed.~      Hypothesis. An asthma educational program based on a limited intervention, managed by~     professionals with minimal training in education, could provide a significant decrease in the~     morbidity of the disease.~      Objective. Determine the effectiveness, in terms of prevention of exacerbations (future risk)~     and improved asthma control (current control) of an educational program based on a reduced or~     minimal intervention.~   "
174397|NCT01282346|"~     To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce~     intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional~     surgical treatments have failed.~   "
174398|NCT01282333|"~     This phase I clinical trial is studying the side effects and best dose of veliparib and~     gemcitabine hydrochloride when given with cisplatin in treating patients with advanced~     biliary, pancreatic, urothelial, or non-small cell lung cancer. Veliparib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving more than one drug (combination chemotherapy) may kill more tumor cells. Veliparib may~     help cisplatin and gemcitabine hydrochloride work better by making tumor cells more sensitive~     to the drugs.~   "
174399|NCT01282320|"~     More than 60 % of women experience hot-flashes during postmenopausal and 20 % have serious~     symptoms. Use of combined estrogen/progesterone therapy reduces hot-flashes effectively. In~     2001, results from the randomized controlled WHI-study (Womens Health Initiative) showed~     increased risk for breast cancer and hearth-disease among users of combined~     estrogen/progesterone therapy. This reduced the use of combined estrogen/progesterone~     therapy. Many women seek alternative treatment for hot-flashes. They are often told that~     physical activity can reduce intensity and frequency of hot-flashes. The evidence for this~     advice is sparse.~      The primary hypothesis tested in the WHAT-study will be: Increased physical activity reduce~     frequency and intensity of hot-flushes among sedentary postmenopausal women with bothersome~     hot-flushes.~      The WHAT-study is designed as a pragmatic randomized controlled clinical trial. To answer the~     primary hypothesis we will need approximately 500 participants. The logistic in a pragmatic~     trial of a complex intervention are complicated and we decided to first run a pilot study~     with 50 participants as a feasibility study. The pilot gives us opportunity to gain~     experience with possible problems like withdrawals and injuries.~   "
174400|NCT01282307|"~     Background:~      Rehospitalisation and discontinued treatment are common among patients with schizophrenia and~     is often associated with lack of insight into the illness. Improving patients' insight has~     been attempted through psychoeducation and standard treatment but without any considerable~     change. A newly developed method, Guided Self-Determination (GSD), originally developed and~     proved effective in difficult diabetes care has been adjusted to patients with schizophrenia.~     A qualitative evaluation of GSD has shown a positive influence on patients' insight into the~     illness.~      Aim and hypotheses: The aim of the study is to evaluate the effects of the method GSD in the~     care of patients with schizophrenia compared to treatment as usual. The following hypotheses~     will be tested:~      The method GSD will improve: Cognitive and clinical insight in patients, various domains of~     recovery, patients' self-esteem, psychopathology and social functioning.~      Material and method:~      The study design is a randomised controlled trial. The participants are diagnosed with~     schizophrenia and schizoaffective disorder, receiving treatment in 3 Assertive Outreach Teams~     and 3 Psychosis Teams in Region North. Participants complete four self-rating questionnaires,~     a demographic data sheet, an interview concerning psychopathology and an assessment of social~     functioning at baseline, and after 3, 6, and 12 month. All assessments will be conducted by~     the investigator, except for the assessment of social functioning, that will be measures by~     community nurses. Intervention with the method GSD will also be conducted by the community~     nurses but under supervision from the investigator. Fifty patients are randomly assigned to~     immediate receipt of individual training with the method GSD (intervention group) and 50 to a~     12-month waiting list for individual training with the method GSD (control group).~      Perspectives:~      In mental health nursing practice in Denmark there is no tradition for empirical research as~     the basis of psychiatric nursing - unverified theories or general empirical consensus of good~     clinical practice are often the foundation of psychiatric nursing. If the method GSD proves~     effective in the care of patients with schizophrenia, this study contributes to an evidence~     based nursing intervention, which is ready for further research on implementation in mental~     health nursing practice.~   "
174401|NCT01282294|"~     This post market clinical follow-up is to confirm the clinical usefulness of the Expert~     Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia~     fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific~     questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse~     Events or complications.~   "
174402|NCT01282281|"~     Background: Most psychotropic medications that are effective in the treatment of Bipolar~     Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no~     long-term study in BD that has examined specifically the association of inflammation with~     EMCs in BD. Specific aims: 1) to identify predictors of EMCs among adolescents and adults~     with BD who are being started on a medication ; 2) to compare change in EMCs in youth and~     adults treated for BD; 3) to measure change in EMCs associated with use of different~     medications for BD. Research Design: Participants: 30 adolescents (14-18 years old) with BD~     and 30 adults (19-65 years old) with BD. Measures: Blood levels of biomarkers that are~     associated with EMCs will be measured.~   "
174403|NCT01282268|"~     To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the~     treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)~   "
174404|NCT01282255|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease~     activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo~     in subjects with active Rheumatoid Arthritis (RA).~   "
174405|NCT01282242|"~     This study was jointly developed and is jointly led by investigators at Massachusetts General~     Hospital and the intramural division of NINDS. We are doing this research study to find out~     if Activase ® (also called alteplase or rt-PA) can safely be given to people with an acute~     ischemic stroke when their stroke onset was not witnessed making them ineligible for standard~     thrombolytic (clot busting) therapy. We also want to find out if rt-PA can help people~     recover better from their stroke.~      The purpose of this study is to: 1) see if it is safe to give intravenous (IV) rt-PA to~     people with unwitnessed stroke but with MRI evidence of early ischemic stroke, 2) see if~     rt-PA is effective if given to people who are selected for treatment based on MRI evidence of~     an early stroke, and 3) get information about this new MRI diagnostic methods for guiding~     stroke treatment.~   "
174407|NCT01282216|"~     This research is being done to understand the effects of certain types of bone marrow~     transplant (BMT) on the immune system. Your doctors are planning a BMT, using one of your~     family members as the bone marrow donor, for your cancer. Part of that BMT involves a~     chemotherapy drug, called Cyclophosphamide (Cytoxan), given after the transplant. This~     research is being done to understand the effects of Cyclophosphamide on the immune system.~   "
174408|NCT01282203|"~     The main objective of this post-marketing observational study is to collect data from the use~     of general anesthesia in patients undergoing any surgery to create local recommendations.~     These data will be based on the evaluation of volatile induction and maintenance anesthesia~     (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for~     surgery in terms of quality of anesthesia and its influence on cardiovascular system in~     common clinical practice in Kazakhstan.~   "
174409|NCT01282190|"~     Evaluate the effectiveness of motivational interviewing to improve lipid control and~     cardiovascular risk in patients with dyslipidemia.~   "
174410|NCT01282177|"~     The overall objective of this study is to provide ongoing assessment of the safety and~     effectiveness of seasonal and pandemic H1N1 vaccines in the prevention of ILI (influenza like~     illness), ILI-associated work absenteeism, and laboratory-confirmed influenza in a cohort of~     Canadian HCP (Health care providers). Given the uncertainties around the timing of the~     provision of seasonal influenza immunization to HCP for the 2009/10 influenza season, this~     study will focus on evaluation of safety and effectiveness of pandemic influenza immunization~     in Year 1 and evaluation of all recommended influenza vaccines in Years 2 and 3.~   "
174411|NCT01282164|"~     The purpose of this study is to find out if the Glucagon Stimulation Test (GST) is a reliable~     alternative to the Insulin Tolerance Test (ITT) for diagnosis of Growth Hormone Deficiency~     (GHD) and adrenal insufficiency. In some patients the accuracy of the GST for evaluation of~     adrenal insufficiency is compared to the adrenocorticotropin hormone (ACTH ) stimulation~     test.~   "
174412|NCT01282151|"~     This study is:~        -  A multicenter, prospective, randomized, phase 3 trial.~        -  To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a~          front line treatment of patients with non-squamous cell lung cancer.~        -  276 patients will be recruited.~   "
174413|NCT01282138|"~     The purpose of this study was to evaluate ocular responses with different allergen~     provocation methods.~   "
174414|NCT01282125|"~     Recent clinical findings of research at Trondheim University Hospital suggest that surgical~     correction of the nose septum in addition to volume reduction of the nose cavity may be~     beneficial in patients who suffer from both nose obstruction and obstructive sleep apnea~     syndrome(data not yet published).~      This study aims to compare nose obstruction prevalence in sleep apnea patients and the~     general population~   "
174415|NCT01282112|"~     This is a retrospective chart review study (700 charts from 2002 to 2010)of children from 0~     to 18 years of age who have undergone Brainstem Evoked Auditory Response (BEAR)testing using~     midazolam and pentobarbital protocol for moderate sedation. The specific aims of this study~     are two-fold:~        1. to determine the efficacy of intravenous pentobarbital during BEAR testing in the~          pediatric population using a standardized protocol; and~        2. to evaluate the incidence of adverse events (major and minor), paradoxical reaction and~          failed sedation and identify predictors for failure and adverse events if any.~   "
174416|NCT01282099|"~     While near infrared spectroscopy is an exciting technology, scientific rigor is required in~     order to optimize its appropriate use in the clinical arena. This study will explore the~     feasibility and clinical applicability of data obtained from the NIRS device. The ability to~     noninvasively monitor peripheral perfusion remains an area of intense research. The most~     widely used method is pulse oximetry. The international mandate of its use in operating rooms~     in the early 1990s after the publication of the Harvard minimum standards for monitoring~     speaks to its unquestionable utility. Its pervasive application notwithstanding, pulse~     oximetry merely provides a calibrated ratio of arterial and venous hemoglobin saturation.~     While this data is valuable, time-tested, and even may hold the promise of accurately~     noninvasively trending cardiac output, cellular dysmetabolism -- hallmarks of vulnerable, yet~     viable tissue beds -- are beyond the predictive values of currently available devices.~   "
174417|NCT01282086|"~     The main objective of this post-marketing observational study (PMOS) is to collect data of~     using general anesthesia in patients undergoing any surgery to create local recommendations.~     These data will be based on the evaluation of volatile induction and maintenance anesthesia~     (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for~     surgery in terms of quality of anesthesia and its influence on the cardiovascular system in~     common clinical practice in Ukraine.~   "
174418|NCT01282073|"~     Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic~     membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The~     investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a~     reasonable alternative with fewer side effect.~   "
174419|NCT01282060|"~     The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C~     LEVEL) and specific causes of death.~   "
174420|NCT01282047|"~     Lenakap : This multicenter, non randomized (single arm), open, phase II study aims to~     evaluated the efficacy of Lenalidomide in HIV-associated kaposi disease. Patients will be~     followed for 48 weeks. Measurement of primary endpoint will be at 24 weeks.~   "
174461|NCT01281514|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and pegylated liposomal~     doxorubicin hydrochloride (PLD) work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Everolimus may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboplatin and~     PLD together with everolimus may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with carboplatin and PLD in treating patients with relapsed ovarian~     epithelial, fallopian tube, or peritoneal cavity cancer~   "
174462|NCT01281501|"~     The purpose of this study is to evaluate the immediate synergistic effect on the relief of~     severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of~     oral antacid and antispasmodic agent (the conventional treatment).~   "
174421|NCT01282034|"~     INTRODUCTION Marrow stimulation techniques as subchondral drilling or microfractures~     represent ones of the most frequently used methods for chondral and osteochodral defects~     repair and considered as standard techniques.~      MaioRegen® (Fin-Ceramica Faenza S.p.A., Italy) is a bioceramic, multi-layered scaffold, in a~     single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium~     enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is~     able to promote the tissue regeneration in case of severe and large chondral/osteochondral~     lesions, otherwise difficult to treat, as previously demonstrated in vitro, in vivo and in a~     clinical study.~      OBJECTIVES The present study proposes to compare MaioRegen® performances with respect to~     reference standard surgical techniques (microfractures and subchondral drilling) for the~     treatment of chondral/osteochondral lesions, in order to consolidate MaioRegen®, as~     innovative surgical approach.~      STUDY DESIGN The clinical trial is multicenter, prospective, randomized, controlled, two-arm,~     single-blind and involves eleven European centres and 150 patients. Eligible subjects will be~     randomly allocated to one of the two treatment groups: control group, treated with marrow~     stimulation techniques, and treatment group, treated with MaioRegen® implant.~      Patient defect will be evaluated pre-operatively and each patient enrolled must meet all the~     entry criteria for the trial. Before enrolment, each subject should declare his voluntary~     participation to the study by informed consent signature.~      Arthroscopic control will be carried out immediately before the randomization and thus~     surgical treatment, to confirm the characteristics of the lesion to be treated and finalizing~     the recruitment.~      For each patient 6, 12 and 24 months post-operative follow-up visits will be carried out and~     during each follow-up visit the Case Report Form (CRF) will be filled in the specific~     section.~      Within the CRF, at each follow-up section, commonly used and specific scores will be assigned~     for the established end-points (IKDC, KOOS, Tegner Score, VAS, MRI Mocart Scoring System).~      Patients selected will be randomized to undergo one of two study groups, as prescribed by the~     randomization list.~   "
174422|NCT01282021|"~     Alloimmunization to blood products in transfused patients is a recognized management~     challenge in the clinical setting. In particular the ethnic and racial specificity of RBC~     antigens and the limited availability of matched healthy volunteer blood donors have~     intensified the dilemma. The presence of low prevalence clinically significant RBC antigens~     among minorities account for the higher rate of alloimmunization observed in patients from~     this group. This is partly due to the racial and ethnic differences between the blood donor~     and recipient populations in the US.~      The increasing number of new Ethiopian-American immigrants in the US presenting to the health~     care system with blood transfusion requirements makes understanding the unique transfusion~     needs of this minority population imperative. Although the majority of African Americans~     claim origin to West Africa, Ethiopians, being from East Africa, represent a rapidly growing~     population in the United States. Furthermore, identifying genetic similarities and~     disparities to their West African counterparts will certainly have clinical implications in~     terms of transfusion support and disease modifiers. This additional information would help in~     understanding the natural history and transfusion requirements of certain debilitating~     diseases, such as Sickle Cell Disease, which are known to occur more commonly in African~     Americans. Identifying ethnically and racially similar individuals could assist in recruiting~     healthy volunteer donors with similar RBC antigen profiles potentially supplementing the rare~     donor pool.~      Although extensive archeological and sporadic serologic RBC antigen studies have been~     conducted in Ethiopia there are no population wide RBC antigen molecular studies. Our study~     population is selected by altitude and migration history. Ethiopia being in close proximity~     to Red Sea in the northeast, Indian Ocean in the southeast and the rest of Africa in the~     south/west has diverse population.~      The study is a population based analysis of genetic variation of blood group antigens in~     three distinct and conserved Ethiopian sub-populations. Statistical analysis using Chi-square~     tests will be performed for each blood group antigen to detect differences in the~     distribution between the three sub-populations. The investigators will travel to Ethiopia to~     collect blood samples which will be analyzed in DTM at NIH using the standard serologic~     methods and currently available molecular genotyping systems. Samples will also be stored for~     future high throughput sequencing analysis and other studies.~      The study will be a systematic analysis of the distribution of blood group antigens in~     Ethiopian sub-populations. Furthermore, new variants could be detected allowing insight in~     correlations of particular genotypes and phenotypes.~   "
174423|NCT01282008|"~     BACKGROUND:~      This document outlines the study design and procedures to be used to evaluate a series of~     corrective statements to augment consumer knowledge and beliefs about smoking as related to~     past actions of tobacco companies. The statements were ordered by a U.S. Federal Court in~     U.S. v. Philip Morris USA, Inc., and are intended to target potential misperceptions~     resultant of past marketing and promotion practices undertaken by the tobacco industry.~      OBJECTIVES:~      The U.S. Department of Justice has asked NCI to take the lead on developing and testing~     corrective statements with adult and youth audiences to ensure both message comprehension and~     avoidance of unintended consequences of message exposure, such as boomerang effects, smoking~     triggers, or knowledge gaps.~      The court has identified five areas that the statements shall address:~        1. The adverse health effects of smoking;~        2. The addictiveness of smoking and nicotine;~        3. The lack of any significant health benefit from smoking low tar, light, ultra light,~          mild, and natural cigarettes;~        4. The tobacco industry s manipulation of cigarette design and composition to ensure~          optimum nicotine delivery;~        5. The adverse health effects of secondhand smoke.~      ELIGIBILITY:~      Message testing will be undertaken with the following audiences:~        -  Current smokers (with an oversample of low socioeconomic status individuals)~        -  General population nonsmokers and former smokers (with an oversample of low~          socioeconomic status individuals)~        -  Spanish-speaking Hispanics~        -  Youth age 14-17~      DESIGN:~      Both qualitative and quantitative methods (focus groups and post-test comparison group~     Web-enabled surveys) will be used to develop and test a range of corrective statements in the~     five areas outlined by the court.~        -  Focus group participants: 48-64~        -  Survey participants: 2500~   "
174424|NCT01281995|"~     Background:~      - Corticosteroids have been used to treat inflammation and immune system diseases for~     decades. However, despite their widespread use, there is little information on the specifics~     of how corticosteroids affect the immune system in humans. The Center for Human Immunology,~     Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone~     hydrocortisone affects the immune system in healthy volunteers, and in doing so to understand~     how hydrocortisone given at different doses works in treating many immune and inflammatory~     conditions.~      Objectives:~      - To evaluate the effects of hydrocortisone on the immune and inflammatory responses of~     healthy volunteers over the short and intermediate term (up to 28 days after administration).~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a full medical history and physical examination, and~          blood and urine tests. At this visit, participants will be separated into two groups,~          with each group scheduled to receive a different amount of hydrocortisone during the~          study visit.~        -  One week before the study visit, participants will provide a blood sample for baseline~          testing.~        -  Participants will be admitted for a 24-hour inpatient stay that will involve frequent~          blood draws. Between blood draws, participants will be able to work, watch TV, walk~          around, and so on, and will be provided with regular meals.~        -  Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be~          divided into two further sets of groups with different blood draw schedules:~        -  Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24~          hours after the hydrocortisone infusion.~        -  Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours,~          with timing based on data from the previous groups blood test results.~        -  Participants will provide additional blood samples 7 and 28 days after the in-patient~          visit.~   "
174425|NCT01281982|"~     Background:~      - The blood-brain barrier helps to protect the central nervous system (brain and spinal cord)~     from harmful toxins, but also prevents potentially useful chemotherapy from reaching brain~     tumors. The barrier is formed by tight connections between blood vessel cells and molecules~     found on the surface of brain blood vessels such as Permeability-glycoprotein (Pgp). Pgp may~     influence whether patients with brain tumors known as gliomas respond to chemotherapy and~     what side effects they may experience. The compound (11C)N-desmethyl-loperamide ((11C)dLop)~     reacts to Pgp molecules, and therefore may be used with positron emission tomography (PET)~     imaging to study the blood brain barrier.~      Objectives:~      - To study the ability of PET imaging with (11C)dLop to evaluate the blood brain barrier in~     brain tumor patients.~      Eligibility:~      - Individuals at least 18 years of age who have a brain tumor with characteristics that may~     be imaged with techniques such as magnetic resonance imaging (MRI) andPET.~      Design:~        -  Participants will be screened with a full physical examination and medical history,~          blood and urine tests, and tumor imaging studies (fluorodeoxyglucose PET and MRI scans~          with contrast agent).~        -  The (11C)dLop scan will take 1 hour to perform. Participants will be asked to return for~          blood and urine tests approximately 24 hours after the PET scan.~        -  Participants will have followup visits at least every 4 months by repeating a complete~          history and physical exam and brain MRI. Participants may have repeat scans with~          (11C)dLop at various points in the course of cancer treatment, but will not have these~          scans more than twice in a 12-month period.~        -  Participants will be followed for as long as possible during treatment to see if imaging~          with (11C)dLop correlates with response to the treatments.~   "
174463|NCT01281488|"~     RATIONALE: Using fluorescence imaging may determine the extent of kidney tumors and help in~     planning surgery.~      PURPOSE: This phase I trial is studying the best way to give indocyanine green (ICG)~     fluorescence imaging in finding tumors in patients with kidney tumors~   "
174426|NCT01281969|"~     Background:~      - Some children experience a sudden onset of symptoms similar to those found in~     obsessive-compulsive disorder that may be caused by the body s reaction to an infection with~     streptococcal bacteria, most commonly seen as strep throat or scarlet fever. When the body s~     immune system reacts against brain cells following a streptococcal infection, the condition~     is known as PANDAS (pediatric autoimmune neuropsychiatric disorders associated with~     streptococcal infections). The immune system response can be inactivated by treatment with a~     drug known as intravenous immunoglobulin (IVIG). Because there is insufficient research on~     IVIG s effects on the immune system of children with PANDAS, including whether IVIG is~     helpful in treating obsessive-compulsive symptoms related to PANDAS, researchers are~     interested in examining whether IVIG is an appropriate treatment for PANDAS and its~     associated symptoms.~      Objectives:~      - To test the safety and effectiveness of intravenous immunoglobulin for the treatment of~     obsessive-compulsive disorder in children with PANDAS (pediatric autoimmune neuropsychiatric~     disorder associated with streptococcal infection).~      Eligibility:~      - Children between 4 and 12 years of age who have obsessive-compulsive disorder (with or~     without a tic disorder) with sudden onset of symptoms following Group A streptococcal~     bacterial infections.~      Design:~        -  Participants will be screened by telephone to obtain medical history and other~          information, followed by in-person screening at the National Institutes of Health~          Clinical Center.~        -  Participants will be admitted to the hospital to receive 2 days of infusions of either~          IVIG or a placebo. Frequent blood samples, imaging studies, and other tests will be~          performed during this visit.~        -  Six weeks after the inpatient stay, participants will return for further blood samples~          and other tests. Participants who did not receive the study drug, or who received the~          drug but did not respond to the initial IVIG infusion, will have the option to receive~          IVIG at this time.~        -  Followup visits will take place 3 months and 6 months after the first evaluation,~          followed by yearly follow-ups for 5 additional years.~   "
174427|NCT01281956|"~     Background:~      - The brain chemical serotonin helps nerve cells communicate. Previous research suggests that~     serotonin activity may be lower in brain areas where seizures start, and that increasing~     activity at the serotonin receptor site on nerve cells may help prevent seizures. Researchers~     are interested in determining whether the experimental medication PRX-00023, which increases~     the activity of serotonin receptors, can reduce seizure frequency in people whose seizures~     are not well-controlled on antiseizure medication. PRX-00023 has not previously been studied~     in people with epilepsy and has not previously been given to people taking antiseizure~     medication at the same time.~      Objectives:~      - To evaluate the effectiveness of PRX-00023 in reducing the frequency of epileptic seizures~     that start from only one part of the brain.~      Eligibility:~      - Individuals between 18 and 65 years of age who have frequent epileptic seizures even after~     trying at least two different standard anti-seizure medications (either at the same time or~     one after the other).~      Design:~        -  The study requires 9 outpatient visits to the NIH Clinical Center over a 34-week period.~          Individuals who choose to participate in additional studies may be an inpatient during~          some of these visits.~        -  Participants will be screened with a medical history and physical examination, blood and~          urine samples, ECG, EEG, neuropsychological studies, imaging studies, including PET and~          MRI scans~        -  Participants will have a 6-week observation and evaluation period before starting the~          study medication. Participants who have at least four seizures during this period will~          be eligible for the treatment portion of the study.~        -  All participants will receive either PRX-00023 or a placebo pill twice daily for 12~          weeks, and will have regular clinic visits with blood samples and imaging studies.~        -  After the 12-week period, participants will have a 2- to 3-week washout period without~          any study medication.~        -  Participants will then have another study medication period, and will receive the~          opposite pill (PRX-00023 or placebo) from the one taken in the first treatment phase.~          Participants will continue to have regular clinic visits with blood samples, ECG, EEG~          and neuropsychologicalstudies.~        -  One month after the end of the second study medication phase, participants will have a~          followup evaluation with a physical examination, blood tests, ECG, EEG, mood and~          neuropsychological tests.~      Outcome measures:~      The primary outcome measure for drug efficacy will be:~      Mean difference in seizure frequency comparing the active and placebo periods.~      Secondary outcome measures for efficacy will be:~      Proportion of patients with greater than or equal to 50% lower seizure rate on PRX-00023 than~     placebo~      Hamilton Depression and Anxiety Rating scales~      Performance on mood and neuropsychological testing scales~   "
174428|NCT01281943|"~     This Phase II study will use the MTD from a previous Phase I study at the recommended dose~     for the combination regimen from the Phase I trial, Doxil 25mg/m2 IV Q 4 weeks and~     temsirolimus 25mg IV Q week.~   "
174429|NCT01281930|"~     Abscesses or boils are becoming more common every year and are a common reason children~     come to the Emergency Department. For the abscess to heal the skin needs to be opened to let~     the pus come out. Often doctors put something called packing material or gauze into the~     abscess space to help aid in healing. It is not known if the type of packing that is done~     is necessary or if a more simple treatment is as good or better. With informed consent we~     randomly place a child into one (1) of two (2) groups in this study that will say if the~     child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece)~     of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment~     in the emergency department the child will be scheduled to follow-up in the Pediatric Acute~     Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this~     visit the healing of the wound will be checked by the staff in the clinic and will be scored.~     With this evaluation of the wound the hypothesis that for a simple superficial (skin)~     abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of~     traditional gauze packing.~   "
174430|NCT01281917|"~     The investigators want to find out if the drugs Velcade and temsirolimus given together are~     effective in treating cancer. Velcade and temsirolimus are each FDA approved individually for~     certain types of cancer (Velcade for multiple myeloma and mantle cell lymphoma, and~     temsirolimus for renal cell carcinoma) but are not currently approved in combination for~     B-cell non-Hodgkin lymphoma. The investigators are trying to find out if giving these 2 drugs~     together will improve the period of time that the patient's cancer is stopped or slowed from~     growing and causing symptoms.~   "
174431|NCT01281904|"~     There are over 2 million breast cancer survivors today. Persistent Cancer-Related fatigue~     (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms~     experienced by breast cancer (BC) survivors. Rates of significant PCRF in BC survivors range~     from 30% to 82% within the first 5-years of diagnosis and there are few treatment options for~     PCRF and these treatments require the availability of a trained practitioner, are associated~     with significant costs, pose a sizeable burden for the patient, or have unacceptable~     side-effects.~      Acupressure is a technique derived from acupuncture, a component of Traditional Chinese~     Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand,~     elbow, or with various devices to treat disease. Pilot studies have demonstrated that~     self-administered acupressure can significantly decrease PCRF by as much as 70% in cancer~     survivors. Acupressure can also have positive effects on sleep quality in cancer patients and~     other chronically ill populations. Self-administered acupressure is a non-toxic and~     inexpensive treatment that requires minimal instruction. It also requires little effort and~     time on the part of the patient to successfully complete. Thus, acupressure appears to be a~     promising treatment for PCRF and associated symptoms.~      The investigators are conducting a single-blind, placebo controlled study to examine the~     specific effect of two opposing acupressure treatments compared to standard of care. The goal~     of this study is to determine the benefit of acupressure on treating persistent fatigue~     experience by many patients after completing their cancer treatment. Study patients will be~     randomized into one of three groups: two different types of acupressure or a standard of care~     arm. For those participants randomized to receive acupressure, the technique will be taught~     to them by a study nurse trained by an acupressure specialist. Participants will be asked to~     perform the acupressure daily over the next six weeks, during which time they will record~     their fatigue and be asked to wear an activity monitor to have their daily activity levels~     monitored.~   "
174464|NCT01281475|"~     This study is designed to determine whether levodopa will lead to an improvement in the~     development and tremor in children with Angelman syndrome (AS).~      It has been suggested that levodopa, a medication that is usually used to treat Parkinson~     disease in adults, may help children with AS in their overall development and reduce the~     tremor that some of them have.~      If levodopa is found to be beneficial for children with AS, this could lead to a new~     treatment for AS.~      Funding Source - FDA-OOPD~   "
174465|NCT01281462|"~     This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing~     treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus~     treatment with IV doripenem.~   "
174432|NCT01281891|"~     Postoperative pain following total hip arthroplasty (THA) (1) is often considered moderate to~     severe and can therefore influence the postoperative course of event and result in delayed~     postoperative mobilization and prolonged hospitalization. It is therefore necessary to find~     the most optimal method for alleviation of pain for these patients. Traditionally, this has~     been managed by epidural analgesia, continuous peripheral nerve blocks, parental- or spinal~     opioids. Recently, Drs Kerr and Kohan at the Joint Orthopaedic Centre in Sydney, Australia~     developed a local infiltration analgesia (LIA) technique. The technique was introduced in~     Scandinavia during 2001 and has been shown to be efficacious during knee surgery. The LIA~     technique is based on a systemic infiltration of a mixture of a long-acting local anaesthetic~     (ropivacaine), a non steroidal anti-inflammatory drug (ketorolac), and epinephrine into the~     tissue around the surgical field to achieve satisfactory pain control with little~     physiological disturbance. A catheter is left from the skin and into the joint cavity,~     allowing repeated injection on the morning after surgery (10). Effective pain relief with~     early mobilization and reduced hospital stay has been reported following total knee~     arthroplasty and, recently, following unicompartmental knee arthroplasty.~      The aim of this study is to assess whether LIA technique is equi-efficacious to intrathecal~     morphine, the standard of care in our hospital.~   "
174433|NCT01281878|"~     In this study the investigators will prospectively analyze the reduction of urinary oxalate~     excretion under the treatment with PLP in dosages of 5mg/kg/day up to 20 mg/kg/day and serum~     level response relationship with PLP as an i.v. solution used orally in 12 patients with~     primary hyperoxaluria type I as an inherited autosomal-recessive-disorder leading to~     increased endogenous oxalate production, urolithiasis and end stage renal disease.~   "
174434|NCT01281865|"~     This phase I/II clinical trial is studying the side effects and best dose of everolimus when~     given with imatinib mesylate and to see how well they work in treating patients with locally~     advanced, locally recurrent or metastatic soft tissue sarcoma. Everolimus and imatinib~     mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
174435|NCT01281852|"~     This phase I clinical trial studies the side effects and best dose of veliparib when given~     together with paclitaxel and cisplatin and to see how well they work in treating patients~     with cervical cancer that has spread to other places in the body and usually cannot be cured~     or controlled with treatment or that has come back. Drugs used in chemotherapy, such as~     paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving more than one drug (combination chemotherapy) and giving chemotherapy together~     with veliparib may kill more tumor cells.~   "
174436|NCT01281839|"~     The purpose of this study is to investigate the effectiveness and safety of TMC435 compared~     with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed~     after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and~     ribavirin as part of their treatment.~   "
174437|NCT01281826|"~     The purpose of this study is to~        1. Assess bone marrow edema within the VCF by use of a DE CT virtual noncalcium image~          compared with MR imaging as standard reference.~        2. Evaluate parameters related to the BME of the collapsed vertebral body on DE CT virtual~          noncalcium images, such as the morphologic signs, visual qualitative detection, and~          quantitative values.~   "
174438|NCT01281813|"~     The primary objective of this trial is to continue the provision of darunavir/ low-dose~     ritonavir (DRV/rtv) to adult and pediatric patients who previously received DRV/rtv in the~     clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the pediatric trial~     TMC114-TiDP29-C232 who continue to benefit from the use of DRV/rtv, in countries where DRV is~     not commercially available for the subject, is not reimbursed, or cannot be accessed through~     another source (e.g., access program, governmental program).~   "
174439|NCT01281800|"~     This is a randomised Phase II clinical trial to assess and compare efficacy and safety~     profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long~     infusion.~   "
174440|NCT01281787|"~     The aim of this study is to assess whether prophylactic treatment with metoprolol or losartan~     is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing thoracic~     surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic peptide~     (NT-proBNP), measured in the perioperative period.~   "
174441|NCT01281774|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     CSL112 in healthy volunteers after multiple infusions.~   "
174442|NCT01281761|"~     Based on the results from preclinical study, the investigators suggest that the addition of~     simvastatin at a dose of cardiovascular use (40 ~ 80 mg qd daily) may overcome cetuximab~     resistance in KRAS mutant colorectal cancer via B-Raf protein degradation and inducing Bim~     and Bad. Given the result of a phase II FOLFIRI plus cardiovascular dose of simvastatin (80mg~     qd daily) and this study, phase II study of conventional cetuximab treatment with 40 mg~     simvastatin is planned in metastatic colorectal cancer patients with KRAS mutation.~   "
174443|NCT01281748|"~     Clinical practice guidelines for the management of chronic obstructive pulmonary disease~     (COPD) recommend treatment with systemic corticosteroids during acute exacerbations. The~     results of a Cochrane systematic review show that treatment with systemic corticosteroids~     improves lung function over the first 72 hours of an exacerbation of COPD but the effect on~     other outcomes, particularly length of hospital stay, is unclear, so further research should~     be directed at determining the risk-benefit ratio, particularly those at high risk of~     developing adverse drug reactions. In critically ill patients, corticosteroid treatment is a~     risk factor of infections, hyperglucemia and critical-illness neuromuscular abnormalities,~     and these conditions are associated with an increased morbidity and mortality. The effect of~     treatment with systemic corticosteroids in COPD patients with acute exacerbation requiring~     mechanical ventilation has not been evaluated investigated so it is unknown if the~     corticosteroids could reduce the duration of mechanical ventilation and the length of~     intensive care unit (ICU) stay or if, on the contrary, the development of adverse events~     could lead to a longer time on mechanical ventilation and ICU stay.~      PRIMARY OBJECTIVES: To evaluate the effect of corticosteroids on the duration of mechanical~     ventilation, the length of ICU stay, the need for tracheal intubation in patients treated~     with non-invasive mechanical ventilation. To evaluate the frequency of adverse events:~     secondary infections, pneumonia, arterial hypertension, hyperglucemia, gastrointestinal~     bleeding, and critical-illness neuromuscular abnormalities. DESING: Multicenter, prospective,~     randomized, double blind, placebo-controlled clinical trial.The treatment group will receive~     intravenous methylprednisolone for 10 days and the control group will receive isotonic saline~     solution.~   "
174444|NCT01281735|"~     The purpose of the study is to describe and characterize CML in a large pediatric cohort of~     patients.~   "
174445|NCT01281722|"~     Melanoma is the most aggressive skin cancer, with a propensity to metastasize, and is~     resistant to most of the current therapeutic regimens. Incidence rate of melanoma in patients~     with MDM (Mal De Maleda, with SLURP-1 mutation) is much higher than normal counterpart.~     SLURP-1 (lymphocyte antigen 6/urokinase-type plasminogen activator receptor related~     protein-1) is an allosteric agonist to the nicotinic acetylcholine receptor (nAchR) and it~     regulates epidermal homeostasis and T-cell function. The preliminary results of comparing~     human peripheral blood mononuclear cells (PBMCs) from 4 affected and 15 unaffected members~     from the family with MDM revealed that T-cell activation was impaired in PBMCs with the~     heterozygous and homozygous SLURP-1 G86R mutation. (2 of affected members developed~     melanoma.) Since there is currently no effective treatment for metastatic melanoma,~     identifying novel molecular mechanisms may lead to development of new treatments for~     metastatic melanomas.~      Previous study showed that melanoma stem cells (MSCs) are crucial in melanoma pathogenesis:~     1.Melanoma contains ABCB5, CD133 and ABCG2 positive cells had enhanced tumorigenic potential.~     2.Higher frequencies of cells capable of initiating melanoma xenografts when using IL2Rγ-/-~     NOD SCID mice. These data confirmed the interaction between T cells and MSCs.~      In this project, we will investigate the roles of SLURP-1 in melanoma and MSCs. Investigating~     and verifying the interaction between T-cells from patients with MDM and melanoma cells to~     confirm the SLURP-1 function of tumorigenesis in xenotransplant mice (IL2Rγ-/- NOD SCID)~     model. To reveal the role of SLURP-1 silencing in melanoma cell lines by using not only A2058~     , A375 and MeWo mwlanima cell lines but also ABCB5+ melanoma cells and ABCB5- melanoma cells~     through the tumorigenesis, apoptosis,angiogenesis, proliferation, melanosphere formation~     assays.~      The aim of this project is to investigate the roles and molecular mechanisms of SLURP-1 in~     melanoma carcinogenesis, which may improve the development of novel treatments for melanoma.~   "
174446|NCT01281709|"~     This questionnaire-based study was focused on understanding primary care physician's wish~     toward provision of integrated health care, associated knowledge and attitude, and analysis~     of influencing factors affecting their choices.~   "
174447|NCT01281696|"~     The main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and~     cisplatin in treating breast cancer patients with central nervous system metastasis~     (including brain parenchymal and leptomeningeal metastasis).~   "
174448|NCT01281683|"~     Hepatocellular carcinoma (HCC) is a major health problem worldwide. For patients with~     intermediate-stage disease, i.e., large or multifocal HCC without vascular invasion or~     extrahepatic spread, transarterial chemoembolization (TACE) is recommended as first line~     therapy with survival advantages. TACE can be performed repeatedly in patients with recurrent~     tumors who have adequate liver function reserves.~      Two clinical issues of TACE remain un-resolved. The first issue is the possibility of~     TACE-induced liver parenchymal damage, which may influence further treatment options and~     outcome of the patients. Conventional ways to evaluate liver functional reserves, including~     Child-Pugh score, biochemistry and metabolic tests, and ultrasound elastography, are~     relatively non-specific. The second issue is the difficulty in evaluating TACE efficacy,~     which cannot be reliably measured by conventional, volumetric response criteria. Both issues~     should be resolved to optimize patient care.~      Recently dynamic contrast-enhancing magnetic resonance imaging (DCE-MRI) is increasingly used~     to analysis perfusion changes of the liver, and can be applied to both liver parenchyma and~     tumors. Previous studies have shown clinical applications of perfusion imaging, such as~     evaluating the severity of liver fibrosis and cirrhosis, assessing the effectiveness of~     anti-angiogenic therapy, and evaluating tumor viability after locoregional therapy. DCE-MRI~     can be performed with a hepatobiliary specific contrast agent, Gd-EOB-DTPA (Gadoxetic acid,~     Primovist®, Bayer Schering), with dual benefit of dynamic phase and the delayed hepatobiliary~     phase imaging. The hepatobiliary phase imaging can provide additional information for hepatic~     lesion characterization and the functional status of the hepatocytes. We hypothesize that~     imaging parameters of DCE-MRI with Gd-EOB-DTPA could reflect non-tumorous liver parenchymal~     changes and can be used to predict and monitor treatment response in patients with HCC after~     TACE.~      In this prospective cohort study, we will recruit patients referred for TACE with~     newly-diagnosed unresectable HCC or tumor recurrence after operation. Patients treated with~     radiofrequency ablation (RFA) will be recruited as a control group, since RFA is associated~     with minimal damage to the non-tumorous liver parenchyma. Key eligible criteria include~     chronic hepatitis B, histological or clinical diagnosis of HCC, tumors that are not amenable~     to surgical treatment and referred for TACE or RFA, ECOG performance status 0 or 1,~     Child-Pugh class A or B liver function, and measurable tumors (by RECIST 1.1). Eligible~     patients will receive the designated treatment (TACE or RFA) according to the current HCC~     treatment guidelines. DCE-MRI with Gd-EOB-DTPA will be used to analyze the non-tumorous liver~     parenchymal changes and treatment response, and will be performed at baseline, 3 days and 1~     month after treatment, and then every 3 months for a maximum of 2 years. The primary endpoint~     of this study is progression of liver function reserve. The estimated time for patient~     recruitment is about half a year, and 40 patients and 20 patients will be recruited in the~     TACE and the RFA treatment group, respectively. The imaging parameters of the non-tumorous~     parenchyma and the tumors will be analyzed and correlated with clinical liver function~     parameters, and hepatic functional and tumor outcome of the patients.~   "
174449|NCT01281670|"~     Muscle force, explosive strength and vertical jump height are important parameters~     determining the performance of athletes. Traditionally, high intensity resistance training,~     explosive strength training and plyometric training are used to improve athletes'~     performance. Recently, whole body vibration training is recommended for increasing muscle~     force and explosive strength, because vibrating platform could provide high gravitational~     acceleration to activate muscle activation and sensory input to spinal reflex. Design:~     Prospective and randomized control study. Subjects: Healthy male subjects with regular~     training or competition at least 6 hours per week. Methods: H-reflex, V-wave, triceps surae~     activation level and rate of force development are measured at pre-training, mid-training~     (5th week) and post-training. Subjects will receive 8 weeks, 3 times/week, training programs~     including plyometric jumping or static squat on whole body vibration platform. Data analysis:~     Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL) and two-way ANOVA~     will be used for data analysis.~   "
174450|NCT01281657|"~     The purpose of this observational study is to collect long-term data on safety and~     effectiveness of fingolimod, particularly including clinical disease and patient outcome~     related parameters such as relapse and disability, in patients who have participated in prior~     trials within the fingolimod clinical development program. Furthermore, this study explores~     the incidence of selected safety related outcomes of fingolimod treatment during follow-up~     visits within the context of routine medical practice.~   "
174451|NCT01281644|"~     The investigators hope to establish whether or not the diode laser, a longer-wavelength~     laser, is effective in treating keratosis pilaris, and hopefully opening a door into the~     discussion and management of this skin condition. The primary outcome of interest is the~     difference in the overall blind rater severity scores of the treated versus the untreated~     sites. The secondary outcome of interest is the change in the patient's self-rated severity~     score of the treated site. To account for potential natural disease progression or~     regression, the investigators will also compare patient mean changes to the mean changes in~     severity scores of the untreated site.~   "
174452|NCT01281631|"~     This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in~     subjects with ALS.~   "
174453|NCT01281618|"~     The purpose of this study is to determine the association between acid reflux and cell~     changes in Barrett's esophagus.~      Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser~     degree of stromal activation.~      Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive~     BE epithelial proliferation.~   "
174454|NCT01281605|"~     This study compared the effectiveness and safety of two treatment algorithms for insulin~     detemir initiation and titration: active titration algorithm (performed by investigator~     weekly) versus usual titration algorithm (performed by study subjects weekly) in patients~     with type 2 diabetes poorly controlled by OADs.~   "
174455|NCT01281592|"~     This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or~     appropriate target dose if MTD not reached to identify the recommended phase 2 dose of~     LOR-253 HCl in patients with advanced or metastatic solid tumours.~   "
174456|NCT01281579|"~     The purpose of this study is to determine blood and urine concentrations of canagliflozin and~     glucose in healthy adult volunteers after administration of single and multiple doses of~     canagliflozin.~   "
174457|NCT01281566|"~     The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding~     problems in premature newborn infants.~   "
174458|NCT01281553|"~     The purpose of this study is to compare the efficacy and tolerability of cisapride with~     placebo in infants and children with gastro-oesophageal reflux disease (GORD).~   "
174459|NCT01281540|"~     The purpose of this study is to assess the effectiveness of cisapride in patients with a~     primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.~   "
174460|NCT01281527|"~     This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of~     flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients~     previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with~     a long duration of action) antipsychotics.~   "
174473|NCT01281332|"~     Hypothesis: A mechanical device when applied to the back of the neck at the onset of a~     menopausal hot flash will attenuate the severity and duration of symptoms providing women~     with a reassuring non-hormonal intervention to improve quality of life in the menopausal~     transition. This pilot study will evaluate the effectiveness of this unit.~      The mechanism of action of the device will not be revealed in advance.~   "
174466|NCT01281436|"~     The purpose of this study is to address priority Research Area 3 in PAR-08-270: Health~     information technology (HIT) to improve health care decision making through the use of~     integrated data and knowledge management. The proposed study will evaluate the use of HIT for~     clinician decision support and tailored patient education on the implementation of the~     current guidelines for the prevention of obesity-related chronic conditions in health~     disparity populations of poor, minority youth who access care through SBHCs. The specific~     aims are:~        1. To evaluate the effectiveness of web-based training with and without computerized~          clinical decision support on provider's process and outcome behaviors related to~          implementing the current guidelines for prevention of obesity and related conditions.~           a. Process variables include the following: i. Provider knowledge, attitudes, and~          barriers to implementing the guidelines. ii. Parent perception of the interpersonal~          process of care (i.e., provider communication, collaborative decision making, and~          interpersonal style).~           iii. Parent perception of provider support for their child's healthy eating and~          exercise.~           b. Behavior outcomes include the following: i. Provider self-reported behaviors of~          identification and assessment of overweight, counseling on nutrition and physical~          activity, use of behavioral interventions, referrals, and cultural competency.~           ii. Documentation by chart review of body mass index (BMI) percentile for age and sex;~          appropriate diagnosis when BMI > 85th percentile; blood pressure (BP) percentile for~          age, height, and sex; and ordering appropriate laboratory tests when indicated.~        2. To explore the role of HIT in the processes of system change for implementation of the~          guidelines for prevention of obesity and related conditions, including the facilitators,~          barriers, and impact of the care model on change.~   "
174467|NCT01281410|"~     The study is a monocentric, controlled randomized trial. Its an interventional method study.~     There is a control and an interventional group. The interventional group is receiving a~     specific inspiratory muscle training with Respifit (special device for inspiratory muscle~     training) during the first 30 days after allogenic stem cell transplantation.~      The investigators want to show that the training group gets stronger inspiratory muscles. The~     investigators measure the change of PIMAX values and MVV values.~   "
174468|NCT01281397|"~     Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful~     data about platelet function and viscoelastic properties of blood clot in patients undergoing~     cardiac surgery.~      The purpose of this study is to clarify whether it is possible to predict patients on~     excessive risk of perioperative bleeding using whole blood impedance aggregometry and~     rotational thromoelastometry.~      Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery~     disease. Another research goal is to determine the degree of response to antiplatelet therapy~     before and after surgery and to investigate whether patients by level of response to~     antiplatelet therapy before surgery have a higher risk of perioperative bleeding.~   "
174469|NCT01281384|"~     Uncovering the underlying cause of heart failure can be quite challenging and doctors often~     rely on imaging tests such as echo (heart ultrasound) to provide the answers. Cardiac MRI is~     emerging as another promising test because it gives very precise information on heart~     function and the amount of scarring in the muscle. Heart failure patients are increasingly~     being sent for cardiac MRI but the potential advantage that this test offers over others such~     as echo has not been fully explored.~      The purpose of this study is to determine if cardiac MRI provides more information on the~     cause of heart failure than traditional tests such as echo. In addition, if the information~     provided by this test always leads to an overall improvement in a patient's heart condition~     over time.~      This is a randomized study where subjects referred for clinically indicated heart failure~     workup to determine the best clinical management will undergo standard heart failure testing~     (including echo) OR standard testing PLUS cardiac MRI.~   "
174470|NCT01281371|"~     Due to the withdrawal of Thelin (Sitaxentan) in December 2010 all patients with pulmonary~     hypertension treated with Sitaxentan need to be switched to an alternative therapy. This~     study will observe in which way the change of medication - in the clinical routine, without~     exception in charge of the treating physician - affects clinical and laboratory parameters~     and patient's quality of life.~   "
174471|NCT01281358|"~     Infants born very premature have biological risk factors for later developmental coordination~     disorder. Parental stereotyping of infants as fragile and other environmental factors, such~     as spending long periods laying on their backs, also contribute to motor delay. This study~     aims to develop and evaluate a computer-based intervention (Helping Our Premature infants ON~     to better motor skills - HOP-ON) for parents of preterm infants. HOP-ON will model evidence~     based strategies to develop infants' fine and gross motor skills, and aims to reduce parental~     stereotyping. It is hypothesised that infants whose parents receive the HOPON CD-ROM/DVD and~     Booklet will have better motor skills at 12 months adjusted age compared to those whose~     parents receive a control CD-ROM/DVD and booklet. Parents of infants born at less than 32~     weeks gestation (target n = 138) will be recruited prior to discharge from the neonatal unit~     and randomised to either HOP-ON or control. The primary outcome is motor score (Bayleys III)~     at 12 months adjusted age. Other outcomes are parental confidence and perceptions of infant~     capability at 3 months and quality of movement, infant growth, fine and gross motor movement~     and parenting stress at 12 months. Data will be analysed blind to study condition and on an~     intention to treat basis.~   "
174472|NCT01281345|"~     Title: A multicenter observational study of candidemia cases among ICU patients in India~      Objective: Primary objective:~      Determine epidemiological and also clinical parameters of candidemia cases among ICU patients~     in India.~      Exploratory Objectives:~        1. Determine the prevalence of candidemia among ICU patients.~        2. Determine the prevalence of candidemia due to C. albicans and each species of~          non-albicans Candida species.~        3. Determine the demographics and risk factors for candidemia patients and comparison of~          relevant variables between the cases with C. albicans and non-albicans Candida species~          isolation.~        4. Describe physician practice in the management of candidemia cases - clinical and~          outcome.~        5. Determine the in-vitro antifungal susceptibilities of Candida isolates.~      Study description and purpose:~      Short description: Observational multicentre study in ICU patients. Study purpose:~     Epidemiological determinants of candidemia, management and outcome evaluation.~      How the study would help? It would help to evaluate outcomes of current management strategies~     and to develop future better management strategies of candidemia cases.~      Critical issues & risk: Site & center selection would be important No risk for patients~     included in the study as it is only observational study~      Study design:~      Site selection: A questionnaire will be circulated (annexure I) to all major tertiary care~     centers of India. The centers will be selected on the competence of candidemia diagnosis and~     availability ICU facilities. Expected number of centers ~ 20.~      Study period: October 1, 2010 - March 31, 2012 No of patients/sites: Consecutive all patients~     with candidemia detected during ICU stay over the study period will be included in the study~     in each site.~      Patient selection: Inclusion criteria:~        1. Admitted in ICU for > 48 hours (to coincide definitions of nosocomial or ICU-acquired)~        2. All age group patients will be included (pediatric & adult)~        3. Diagnosed as proven candidemia (isolation of Candida species from blood culture on ≥ 1~          occasion during ICU stay)~        4. Blood culture positive for Candida spp. , if sample has been drawn within 48 hrs after~          discharge from the ICU.~      Exclusion criteria:~      1. Patient already diagnosed of candidemia before admission in ICU Variables|: types of ICU,~     demographic data of patients, underlying illness, risk factors, severity scores, diagnostic~     methods, treatment characteristics (Annexure II) and treatment outcomes (Annexure III)~      Diagnosis of candidemia: Isolation of Candida species from blood culture (arterial/venous) by~     any method (conventional/ lysis-centrifugation/ automated system/ any other method). No~     intervention in diagnostic processes at any center. Centers not performing diagnosis of~     candidemia will be excluded from the study~      Data recording: both manual and online. The form of Annexure II will be filled up within 5~     days of diagnosis of candidemia; Annexure III will be filled up within 7 days of discharge~     from hospital or 30 days after starting the antifungal therapy or death of the patient (which~     over period is early).~      Data analysis: appropriate statistical method will be employed for analysis of data.~   "
174491|NCT01281098|"~     To evaluate the safety and determine the efficacy of PRP monotherapy or combination therapy~     (pegaptanib 0.3 mg plus PRP) in patients with Type I or Type II diabetes mellitus and with~     high risk proliferative diabetic retinopathy.~   "
174474|NCT01281319|"~     Subclinical urogenital infections have been implicated in up to 70% of adverse pregnancy~     outcome, especially preterm labor and delivery. The most prevalent microorganisms involved in~     intrauterine infections are urogenital Mycoplasmas. Diagnosis by culturing or PCR merely~     detect the presence of the bacteria, pointing to colonized carriers only. There is no~     efficient and reliable diagnostic test to identify those subjects that have developed an~     infectious disease and are at risk of developing adverse pregnancy outcome.~      In order to identify women at risk for developing pregnancy complications, Promyco~     Diagnostics has developed a proprietary, simple and non-invasive serology diagnostic kit for~     the detection of urogenital Mycoplasma infection.~   "
174475|NCT01281306|"~     The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses~     of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed~     dose of valsartan (320 mg).~   "
174476|NCT01281293|"~     Vagus Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy~     since 1994. This post-market study is designed to follow the clinical course and outcomes for~     patients with refractory seizures treated with adjunctive VNS Therapy. Seizure frequency,~     seizure severity, side effects burden, depressive symptoms, global impressions, and health~     care utilization will be evaluated. The results of this study will provide data to guide~     physicians and their patients in the use of VNS Therapy for patients with refractory seizures~     who have failed initial trials of anti-epileptic drug (AED) therapy. The data being collected~     is not for the purposes of confirmatory assessment.~   "
174477|NCT01281280|"~     This is a post-market, open observational long-term effectiveness follow-up study of~     participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in~     a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without~     adjunctive Vagus Nerve Stimulation Therapy.~   "
174478|NCT01281267|"~     Face transplantation surgery is the transfer of face tissue from a deceased human donor to a~     patient with a severe facial deformity. Face transplantation is an innovative reconstructive~     procedure that has the potential to significantly improve the lives of patients with severe~     facial injuries. The purpose of this study is to develop the best practices for facial~     transplantation that will improve the outcomes of future face transplant recipients.~   "
174479|NCT01281254|"~     To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo~     plus PLD as measured by progression-free survival (PFS)~      The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo~     plus PLD in women with recurrent partially platinum sensitive or resistant epithelial~     ovarian, primary peritoneal or fallopian tube cancer.~   "
174480|NCT01281241|"~     The main objective is to investigate mechanical alternans and MTWA in patients with heart~     failure caused by coronary artery disease to demonstrate a possible correlation between these~     two phenomena.~   "
174481|NCT01281228|"~     Glucagon-like peptide 1 (GLP-1) based therapies, such as exenatide, are already successfully~     employed in the treatment of Type 2 Diabetes (T2DM). Exenatide improves glycemic control and~     is associated with reduced food intake and body weight. The investigators hypothesize that it~     affects central reward and satiety circuits and that this may contribute to the weight loss.~   "
174482|NCT01281215|"~     The purpose of this study is to develop, implement and evaluate an economically viable and~     efficient interventions education model for rational drug use, adaptable to different~     pathological situations and should be implemented into Brazil Heath Care System.~   "
174483|NCT01281202|"~     The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent~     subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use~     of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher~     than seen in subjects treated with placebo in addition to counseling.~   "
174484|NCT01281189|"~     The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe~     and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).~   "
174485|NCT01281176|"~     This randomized pilot clinical trial studies high-dose or low-dose vorinostat in combination~     with carboplatin or paclitaxel in treating patients with advanced solid tumors. Vorinostat~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving different doses of vorinostat together with~     carboplatin or paclitaxel may kill more tumor cells.~   "
174486|NCT01281163|"~     This phase I trial studies the side effects and the best dose of lapatinib ditosylate and Akt~     inhibitor MK2206 in treating women with metastatic breast cancer. Lapatinib ditosylate and~     Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
174487|NCT01281150|"~     This phase I clinical trial studies the side effects and the best dose of veliparib when~     given together with carboplatin and paclitaxel in treating patients with locally advanced or~     metastatic solid tumors. Veliparib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by blocking them from dividing. Giving veliparib with carboplatin and paclitaxel may~     work better in treating patients with solid tumors.~   "
174488|NCT01281137|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving treatment for~     cancer may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This clinical trial is studying changes in estrogen levels and grip strength in~     postmenopausal women who have received 4 to 6 years of hormone therapy for breast cancer and~     are currently receiving letrozole on clinical trial IBCSG-35-07.~   "
174489|NCT01281124|"~     This phase II clinical trial is studying how well azacitidine works in treating patients with~     previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as~     azacitidine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~   "
174490|NCT01281111|"~     The purpose of this study is to evaluate the safety, tolerability, and PK of different doses~     and dosing regimens of BG00012 administered with and without ASA compared to placebo.~   "
174492|NCT01281085|"~     Questionnaires are frequently used to evaluate shoulder function in various diseases or after~     surgery. However, measurement of shoulder function is presently a controversial issue.~     Shoulder movement analysis based on embedded sensors could be a promising alternative to~     questionnaires. Some studies already demonstrated the relevance of this approach. It has also~     been demonstrated that a simple testing procedure including only two arm movements produces~     comparable results to more complicated testing procedures. However, more studies are needed~     to extensively establish if this simplified testing procedure provides a trustworthy~     evaluation of patient shoulder function and its evolution.~      This study is a preliminary study which aims to develop a precise testing procedure which~     will be used in a future study aiming to evaluate measurement properties of a simple shoulder~     function test based on movement sensors.~   "
174493|NCT01281072|"~     Open label study to evaluate long term treatment effect of diapep277.~   "
174494|NCT01281059|"~     The Exalenz clinical investigation is a multicenter, non-randomized, blinded, study of the~     ¹³C-Octanaote breath test (OBT). The OBT is a non-invasive test for evaluation of disease~     severity in patients with suspected non alcoholic fatty liver disease (NAFLD) The purpose of~     the study is to demonstrate that the ¹³C-Octanaote Breath Test (OBT) can be used as an aid,~     in conjunction with other clinical information and medical history, for evaluating disease~     severity and detecting non alcoholic steatohepatitis(NASH) with a high probability.~      Retrospective analysis based on multivariable analysis will determined if and which~     demographic, clinical and biochemical or imaging techniques data can assist in addition to~     the data derived from OBT in differentiation of NASH, NAFL and possibly normals.~   "
174495|NCT01281033|"~     To compare rheolytic thrombectomy (RT) with manual thrombus aspiration (MTA) in patients with~     acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.~      Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the~     anatomic substrate of ST-segment elevation myocardial infarction (STEMI). Due to this~     substrate, macro- and microembolization during percutaneous coronary intervention (PCI) in~     AMI is frequent and may result in obstruction of the microvessel network, and decreased~     efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or~     postdilation is the most simplistic approach to the problem of embolization, and may decrease~     embolization and the incidence of the no-reflow phenomenon. Other approaches to the problem~     of microvessel embolization include thrombectomy before stent implantation, and the use of~     antiembolic devices (filters and occlusive devices with retrieval of thromboembolic material~     after stent implantation). Most concluded studies on removing of thrombus before stenting~     used manual aspiration catheters and meta-analyses derived from these studies support the use~     of manual thrombus aspiration (MTA) catheters in the setting of primary PCI. MTA is currently~     recommended in the setting of primary PCI as a Class II b recommendation; level of evidence~     B. Rheolytic thrombectomy (RT) using multiple jets of saline solution and aspiration based on~     the Bernoulli effect has been proven to be effective in decreasing major adverse events~     during PCI in saphenous vein grafts or native coronary arteries with angiographic evidence of~     thrombus, and 2 out of 3 concluded studies have shown a better reperfusion and clinical~     outcome in patients randomized to RT as compared to control.~   "
174496|NCT01281020|"~     A 6-month, parallel, non-interventional trial investigating the level of adherence and the~     impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with~     latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed~     combination therapy once in the evening. All patients participating in this observational~     study will be monitored for their adherence with the use of Medication Event Monitoring~     System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with~     selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This~     study will monitor objectively, for the first time, adherence and intraocular pressure~     control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact of~     dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.~   "
174497|NCT01281007|"~     Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by~     herpes simplex virus (HSV). There are effective oral prescription antiviral medicines~     available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.~      This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy~     and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with~     active recurrent genital herpes.~   "
174498|NCT01280994|"~     The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas~     for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI~     contrast will be the investigators focus — 1) imaging of the 129Xe ventilation distribution,~     2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC),~     and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such~     imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting~     gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding~     the normal resting heterogeneity of pulmonary gas exchange.~   "
174499|NCT01280981|"~     This was a multicenter, open-label extension study for subjects completing either of 2~     pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment~     phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g~     administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation.~     After the last treatment period, a follow-up phone call occurred approximately 30 days (range~     25 to 35 days) after the last dose of study drug.~   "
174500|NCT01280968|"~     The purpose of this study is to find out how vaccine-induced antibodies change the way the~     body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce~     nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The~     central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine~     accumulation and distribution of nicotine between the brain and other body tissues. This~     vaccine is investigational which means that it is still being tested in research studies and~     is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.~   "
174797|NCT01277107|"~     This is a multi center, double blind placebo controlled, two-way crossover study in patients~     with Insomnia suffering from difficulty in falling asleep and staying asleep. This study~     intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to~     placebo.~   "
174501|NCT01280955|"~     This phase I/II clinical trial will test the safety and the efficacy of post transplant~     administration of plerixafor in enhancing hematological recovery in humans. Patients who are~     appropriate candidates for myeloablative allogeneic stem cell transplantation from an~     HLA-matched sibling, matched unrelated donor or umbilical cord blood are eligible for~     enrollment. The investigators plan to enroll a total of 50 patients for this study (30~     patients with HLA-matched sibling or matched unrelated donor transplant, and 20 patients with~     umbilical cord blood transplant). During phase I study, a small number of patients (3-6~     patients from each group) will be enrolled to determine the safety of post transplant~     administration of plerixafor. Patients will receive plerixafor given at 240 µg/kg~     subcutaneously every other day beginning at day +2 after transplant until day +21 or~     engraftment. Limiting toxicities are defined as primary or secondary graft failure,~     plerixafor-related severe premature ventricular arrhythmia or death. If safety criteria are~     met from the investigators phase I study, the investigators will proceed with phase II study~     to determine the efficacy of post transplant administration of plerixafor in enhancing~     haematological recovery. The experimental aspect of this study is the use of plerixafor and~     all other aspects of care will be in line with the standard of care. Both Phase I and Phase~     II patients will be combined for efficacy analysis, and data collected from this study will~     be compared with the investigators historical control. The results from this study will set~     the stage and provide the justification for a larger phase 3 trial.~   "
174502|NCT01280942|"~     The goal is to develop a two-tiered monitoring system to improve the care of patients at risk~     for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH).~     The investigators hypothesize that the use of an automated early warning system (EWS) that~     identifies patients at risk of clinical deterioration, with notification of nurses on the~     GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24~     hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse~     oximeter to establish feasibility and to develop algorithms for a real-time event detection~     system (RDS) in these high-risk patients.~   "
174503|NCT01280929|"~     The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous~     injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of~     ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation~     alone in the regression of retinal neovascularization in eyes with high-risk proliferative~     diabetic retinopathy.~   "
174504|NCT01280916|"~     The primary purpose of this exploratory and developmental study is to evaluate a mind-body~     intervention for relapse prevention for women in addiction treatment. The proposed~     intervention, Mindful Awareness in Body-Oriented Therapy (MABT), is a novel mind-body~     intervention designed to enhance embodiment and to facilitate mindfulness through the~     combination of massage, body awareness exercises and the acquisition of mindfulness skills.~     The treatment goals of MABT include reduction of avoidant coping responses, increase of~     emotional-regulation, and decrease of trauma symptoms through access to and acceptance (vs.~     avoidance) of sensory and emotional experience. These are thought to be important for relapse~     prevention given the positive association between stress, negative affect and relapse; and~     risk of relapse associated with PTSD symptoms. Mind-body interventions in relapse prevention~     are of increased clinical and scientific interest, particularly for the potential to overcome~     automatic response patterns that are associated with lapse and relapse in substance use~     treatment. This proposal falls within the current NIDA research portfolio focus on the~     development of interventions that will help people better cope with stress, negative affect,~     and trauma.~      Specific Aims:~        -  Aim 1: To examine feasibility of recruitment to and retention in MABT as an adjunct to~          substance abuse treatment. Specifically, to describe a) study enrollment and barriers to~          recruitment, b) sample characteristics, c) response to randomization, d) session~          attendance, and e) loss to follow-up.~        -  Aim 2: To describe MABT acceptability to study participants and substance abuse~          treatment staff.~        -  Aim 3: To compare the effect of body-oriented therapy plus treatment-as-usual vs.~          treatment-as-usual only on reported days abstinent for overall substance use and primary~          drug use among women receiving substance abuse treatment, in order to estimate the~          effect size. Secondary analyses will examine for intervention effects on related~          outcomes including days abstinence on biochemical screens for substance use, body~          connection indicators, avoidant coping, stress reactivity, co-morbid psychological~          distress, and physical well-being.~   "
174505|NCT01280903|"~     The purpose of the Staying Active with Arthritis (STAR) research study is to determine if a~     6-month program will improve leg exercise, fitness walking, and clinical outcomes (function,~     blood pressure, leg strength, pain, fatigue, and health-related quality of life) in older~     adults with osteoarthritis of the knee and high blood pressure.~   "
174506|NCT01280890|"~     Dementia is a common and devastating disease in the elderly. No cure exist and there is an~     increasing need for care. To improve knowledge on how to provide better care for the patients~     with dementia in nursing homes, the investigators will carry out a controlled trial using two~     forms of education and developmental interventions towards the nursing home care staff: a~     structured framework (VIPS) and dementia care mapping (DCM)to develop person-centred care in~     a 10 months randomised controlled study. In accordance with the knowledge found in the~     literature the investigators hypothesize that both VIPS framework and DCM will be more~     effective than a traditional educational program about dementia provided to the staff in~     nursing homes. The positive effects will be seen as reduced agitation in patients, less use~     of psychotropic drugs and improved quality of life. Using VIPS framework and DCM will also~     have a better effect on staffs' well-being than traditional education in dementia. The aim of~     the study is to confirm or reject these hypotheses.~   "
174507|NCT01280877|"~     Aim is to validate that non-invasive brain stimulation can increase cortical excitability in~     the visual system. The investigators assess if transcranial alternating current stimulation~     (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS~     would improve visual functions within the defective visual field (primary outcome measure).~   "
174508|NCT01280864|"~     Hypotheses:~        1. The bidirectional signaling between the cortex, and the pelvic floor/gut is deranged in~          patients with IC and in IBS. Consequently, they will demonstrate hyperexcitability of~          the pelvic floor/brain axis as evidenced by shorter latencies and increased amplitudes~          for both the afferent anorectal-cortical evoked potentials and efferent~          cortically-induced (magnetic) anorectal motor evoked potentials.~        2. Unlike patients with IC alone, patients with IBS will also demonstrate anorectal~          visceral hypersensitivity and anorectal sensory-motor dysfunction.~   "
174534|NCT01280526|"~     This study is an open label, multicenter study with two phases:~        -  A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without~          day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone~          (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma.~        -  An expansion phase in order to assess the safety and the efficacy of the association of~          the recommended dose of Romidepsin associated with CHOP in a population of patients with~          T-cell lymphoma.~   "
174509|NCT01280851|"~     Accurate preoperative evaluation of a potential living renal donor's anatomy, vasculature and~     function is crucial to ensure optimal outcomes for both kidney donor and recipient in~     transplantation.~      Currently abdominal ultrasound and spiral CT angiography are used to evaluate renal anatomy~     and vascular status, and renal scintigraphy to evaluate renal function. This imaging protocol~     exposes this relatively young and healthy population to a high radiation dose and potentially~     nephrotoxic contrast agents.~      The investigators hypothesize that a single MR-based examination in the preoperative~     evaluation of potential kidney donor is a faster, safer, more cost effective and as accurate~     as the current multiple imaging work-up protocol.~   "
174510|NCT01280838|"~     Behavioral interventions designed to reduce risk of HIV and sexually transmitted infections~     (STIs) have mostly failed to consider clients of female sex workers (FSWs), who may act as a~     bridge to the general population. This study proposes to test a brief, one-hour counseling~     intervention with male clients in Tijuana, Mexico, to reduce their rates of unprotected sex~     (i.e., sex without a condom) with FSWs as well as their rates of infection with HIV and STIs.~     Finding an effective intervention for this population is important given the rising rates of~     HIV infection in Tijuana (as documented in earlier studies) and the large numbers of people~     crossing the border in both directions, many of them specifically to purchase sex from FSWs~     in Tijuana.~   "
174511|NCT01280825|"~     The purpose of this study is to collect DNA samples from patients undergoing routine care at~     the University of Chicago. These samples will be tested for differences in genes that may~     suggest greater risk of side effects or chance of increased benefit from certain medications.~     The results will be made available to the patient's treating physician and the researchers~     will track whether or not this information is used in routine health care.~   "
174512|NCT01280812|"~     The primary purpose of this study is to assess the efficacy of the mobile phone-based~     physical activity intervention on increasing physical activity compared to the control group.~   "
174513|NCT01280799|"~     This treatment development study seeks to investigate the most effective way to treat an~     adolescent's eating disorder and how best to involve the parents or caregivers in this~     process.~      Typically, parents and their child are seen together in therapy. However, this can sometimes~     be difficult for both the parents and the adolescent. Both parents and adolescents have~     different concerns and are struggling with different aspects of the eating disorder.~     Therefore, the treatment in this study involves the parents in treatment, but the majority of~     therapy sessions are conducted with the parent(s) and adolescent separately.~      Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the first~     16 weeks parents and the adolescent meet individually with the therapist. For the last 8~     weeks families meet with the therapist every other week. These last four sessions are~     conjoint - that is, adolescents and parents will meet with the therapist together. This is to~     help parents and adolescents come together as a family to continue to aid the adolescent in~     the treatment of his/her eating disorder.~      The investigators hypothesize that adolescents who receive this treatment will demonstrate~     improvement in eating disorder symptoms and body-mass index and that caregivers who~     participate will demonstrate decreased distress and caregiver burden. Furthermore, the~     investigators hypothesize that increases in psychological acceptance will be seen for both~     adolescents and caregivers post-treatment, and that treatment will be viewed as both credible~     and acceptable to both caregiver and adolescent.~   "
174514|NCT01280786|"~     This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to~     patients with advanced myeloid leukemia.~   "
174515|NCT01280773|"~     It has been showed that over assist and patient ventilator asynchrony often occur in~     mechanical ventilated patients, especially in patients who failed weaning, which are~     associated with a prolonged duration of mechanical ventilation. NAVA improves~     patient-ventilator synchrony, prevents excessive assist induced diaphragm inactivation. So~     the aim of this study was to detect that whether NAVA compared with PSV has the ability to~     reduce the duration of weaning in difficult to wean patients.~   "
174516|NCT01280760|"~     Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory~     dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces~     the airtightness of the facial mask used to perform non-invasive ventilation and induces air~     leaks. The presence of leaks at the patient-mask interface can increase the risk of~     patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally~     adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is~     to record the diaphragmatic electrical activity and to control the ventilator. The~     investigators hypothesized driving the ventilator based on a neural signal (diaphragm~     electrical activity) would reduce patient-ventilator asynchronies in NIV~   "
174517|NCT01280747|"~     The investigators hypothesize that fibromyalgia (FM) and painful diabetic peripheral~     neuropathy (pDPN) patients with access restrictions on pregabalin will lead to higher~     healthcare resource use and cost compared to patients without such restrictions on pregabalin~     in a naturalistic setting. The randomization will occur at the physician level and not the~     patient level.~   "
174518|NCT01280734|"~     This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study~     investigating the effect on night time awakening body sway of melatonin and zolpidem in~     healthy adult subjects aged of 55 to 64 years.~   "
174519|NCT01280721|"~     ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of~     tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).~   "
174532|NCT01280552|"~     This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in~     treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an~     immunotherapy in which the patient's immune response will be stimulated to kill the tumor~     cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some of~     the patient's white blood cells (WBC) will be removed and cultured in a laboratory with~     purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been~     exposed to the tumor antigens will then be given back to the patient as a vaccine over~     several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune~     response to kill the remaining GBM tumor cells after surgery and chemotherapy.~   "
174533|NCT01280539|"~     In this study the researchers want to investigate the effects of long-term transcutaneous~     electrical nerve stimulation on the cortical excitability of persons with multiple sclerosis.~   "
174520|NCT01280708|"~     The aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation - Urology)~     is to organize a thematic network in urology traced on NetWork DIVAT to supplement the~     medical and biological data of DIVAT existing cohort with parameters of surgical~     transplantation of kidney and pancreas. These data will concern the transplantation itself~     and the events and complications related to surgery occurring throughout the follow-up. The~     collection will involve patients in the cohort DIVAT and future patients. This project will~     allow us to have the sufficiency of surgical transplantation by increasing the quantity and~     quality of information gathered thus avoiding the biases commonly upbraided against the~     retrospective studies. Finally, by supplementing it with new parameters, it will strengthen~     the medical and scientific interest of the cohort DIVAT and will open new perspectives for~     clinical trials in surgery and work in epidemiology.Networking of urologists and the~     expansion of the base DIVAT would carry out research in epidemiology and factors that may~     play a role in the outcome of renal and pancreatic transplantation. It would also help to~     define good practices. The first study from the proposed network DIVAT-Uro is assessing the~     impact of vesico-ureteric reflux on the occurrence of urinary tract infections and effects on~     survival of the transplant in the recipient adult.~   "
174521|NCT01280695|"~     The purpose of this study is to assess the safety and tolerability of MSDC-0602 and to~     evaluate the reduction in fasting plasma glucose in patients with Type 2 diabetes.~   "
174522|NCT01280682|"~     Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease~     immune-mediated destruction of beta cells and result in preserved beta-cell function in~     patients with type 1 diabetes of recent onset.~   "
174523|NCT01280669|"~     The purpose of this study is to find out about the safety and effectiveness of two different~     doses the study drug, sirolimus, administered intravitreally in patients with uveitis. The~     potential effectiveness of sirolimus can be utilized to control inflammation in uveitis and~     yet avoid the potential complications that are usually associated with the systemic use of~     the drug and other immunomodulatory therapies. In this study, the investigators will~     administer sirolimus inside the eye (intravitreally) in one of two doses (440mcg/mcL or~     880mcg/mcL). Local administration of sirolimus to the eye is not expected to have effects on~     the rest of the body. Therefore, it may offer a safer way than the current methods used to~     control the inflammation caused by non-infectious uveitis.~   "
174524|NCT01280656|"~     This retrospective study will assess the sustained virologic response and the safety of two~     different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data~     will be collected for 24 weeks.~   "
174525|NCT01280643|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin,~     capecitabine, and irinotecan hydrochloride, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving more than~     one drug (combination chemotherapy) and giving the drugs in different combinations may kill~     more tumor cells. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     combination chemotherapy together with bevacizumab or cetuximab may kill more tumor cells.~      PURPOSE:To evaluate the use of standard (KRAS) and experimental (thymidine phosphorylase,~     ERCC1 and BRAF) tumor testing can aid in selecting chemotherapy regimens~   "
174526|NCT01280630|"~     TRACE is a Multicentre Retrospective Study planned to gather follow up data for a period of 1~     year in order to understand anti-thrombotic management patterns and outcomes of Acute~     Coronary Syndrome patients in India.~      This retrospective study is designed to provide a rapid and quick analysis of the existing~     database of ACS patients. So as to ensure quality check in the study, a pilot study will be~     conducted with around 500 patients at 10 centres across India and based on the meaningful~     results of the pilot study, full retrospective multi-centric study will be initiated at~     various selected centres across India. This study will use available registry data from a~     defined time period of Jan 2007-Dec 2009.~   "
174527|NCT01280617|"~     This is a planned single center prospective randomized study evaluating the safety and~     efficacy of low dose thymoglobulin as induction agent in renal transplant recipients.~     Inclusion criteria will be adult renal transplant recipients who are not sensitized against~     their potential donors. The patients who agree to participate in the study will be randomly~     assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be~     86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing~     and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose~     the sealed envelopes at the time of the patient randomization process. All patients will be~     started on our standard immunosupression regimen of prograf/cellcept and a fast steroid~     taper. Data will be obtained from every patient for up to one year post-transplant.~   "
174528|NCT01280604|"~     The primary objective of this randomized trial is to measure the impact of converting~     patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who~     continue fenofibrate 160mg per day for triglycerides.~   "
174529|NCT01280591|"~     The objective of the study is to evaluate the efficacy and safety of a single oral dose of~     two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that~     naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than~     either single ingredient alone in subjects with post-surgical dental pain and phase advanced~     sleep.~   "
174530|NCT01280578|"~     A prospective, single arm, multicenter clinical registry evaluating the change in migraine~     headaches in migraine with aura patients who undergo patent foramen ovale (PFO) closure with~     the Coherex FlatStent™ EF PFO Closure System.~   "
174531|NCT01280565|"~     Masitinib is a novel TKI that potently inhibits wild type (WT) c-kit and its activated form,~     mutated in the juxtamembrane region (JM c-kit) PDGFRs, the intracellular kinase Lyn, and to a~     lesser extent fibroblast growth factor receptor 3 (FGFR3).~      Pre-clinical data suggest that masitinib is a strong candidate for the treatment of patients~     with advanced melanoma carrying a c-kit JM mutation.~   "
174535|NCT01280513|"~     The purpose of this study is to modulate the protein fermentation and to investigate the~     effect on colon toxicity.~   "
179432|NCT01216332|"~     This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent~     inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with~     Acute Lymphoblastic Leukemia.~   "
174536|NCT01280500|"~     The overall goal is to identify best practices for improving health outcomes for patients~     with asthma using comparative effectiveness research within an Agency for Healthcare Research~     and Quality (AHRQ) Practice-Based Research Network (PBRN). This goal will be achieved by~     completing the following aims: (1) Create a centralized database for comparative~     effectiveness research on asthma by combining clinical and billing data from one of the~     largest healthcare systems in the country (Carolinas Healthcare System) with data from the~     school system, Medicaid, and patient and community-level datasets; (2) Deploy a fully~     developed integrated approach to asthma management based on the Chronic Care Model; (3)~     Develop and implement a shared decision making approach for asthmatic patients from~     disadvantaged backgrounds; (4) Implement an electronic data collection system for an existing~     CDC funded school-based asthma intervention that will allow program evaluation and link~     school nurses with providers; (5) Evaluate and compare the effectiveness of these three~     asthma management strategies on: overall healthcare consumption and medical costs; quality of~     life, school absenteeism and performance; asthma clinical measures; and medication~     utilization; and (6) Disseminate findings across the state via the statewide PBRN and other~     network partners. This project has the potential to impact over 30,000 asthma patients across~     the Carolinas including many patients from disadvantaged backgrounds.~   "
174537|NCT01280487|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and~     preliminary efficacy of daily oral doses of ZSTK474, an oral phosphatidylinositol 3-kinase~     (PI3K) inhibitor, in subjects with advanced solid malignancies.~   "
174538|NCT01280474|"~     This study aims at investigating the effects of maternal depressive symptomatology on~     pregnancy outcomes and newborn development. How paternal psychopathology is involved in the~     association will also be explored.~      This is a three-year prospective cohort study. Three versions of questionnaires (the mother,~     the father, and the infant) will be developed first. For parents, data on self-reported~     symptomatology such as depression, anxiety, and stress will be collected, while for infants,~     maternal report on newborn development will be measured. Then, two medical centers and two~     regional hospitals will be selected. All pregnant women who undergo a first-trimester~     prenatal visit, who plan to carry the baby till term, and whose spouse is also willing to~     participate will be invited to join the study. The investigators expect to recruit a total of~     194 pairs of depressive mothers and her spouses and 278 pairs of non-depressive mothers and~     her spouses in the study.~      After the informed consent is obtained, one baseline assessment (i.e., the first trimester)~     and four follow-up assessments (i.e., the second trimester, the third trimester, one month~     postnatal and six months postnatal) will be implemented. Basically, prenatal investigation~     (for both mothers and fathers) will be carried out at the outpatient prenatal visit.~     Postnatal investigation (for the mothers, fathers and infants) will be processed at the~     pediatric outpatient visit when the infants are schedule for an immunization injection. After~     data are collected, descriptive, analytic and longitudinal data analyses will be performed to~     investigate the association between parental psychopathology and pregnancy outcomes and~     newborn development.~      This study will explore the effects of the developmental trajectories of parental~     psychopathology on newborn growth during the critical stage of pregnancy. It is hoped that~     evidence based data could be obtained, examined, and applied in future~     prevention-intervention program to promote parental and newborn health, both physically and~     psychologically.~   "
174539|NCT01280461|"~     This is a phase III, multi-center, open-label, comparative and randomized study in evaluating~     the efficacy and safety of cefoperazone/sulbactam versus cefepime for the treatment of~     hospital-acquired pneumonia and healthcare-associated pneumonia. The investigator will~     determine the total duration of study therapy, as clinically indicated. The minimum duration~     of study therapy will be 7 days and the maximum allowable duration of study therapy will be~     21 days.~   "
174540|NCT01280448|"~     Lung cancer is the leading cause of cancer deaths in Taiwan. The carcinogen in the~     environment is a key role in the development of lung cancer, and one of its main resource is~     tobacco. Activated carcinogens in the organism lead to mutations of crucial oncogenes~     resulting in tumor development. Genes such as Cytochrome P-450 family, GST (glutathione~     S-transferase) family, UGT (UDP-Glucuronosyltransferase) family, ERCC-1(excision repair~     cross-complementing rodent repair deficiency),ERCC-4 and ERCC-5,are encoding antioxidant~     enzymes or involving in the DNA repair process and the production of some transcription~     factors. In recent years, many studies have shown the correlation between these genes and the~     susceptibility of lung cancer. Each gene has a different role in the tumor development~     pathway. CYP, UGT, GST, NAT2 (N-acetyltransferase 2) and NQO1(NAD(P)H:quinono oxidoreductase~     1) involve in the production of antioxidant enzymes. The antioxidant enzymes can detoxificate~     hydrogen peroxide or defense against oxidative stress. However, the genetic polymorphisms may~     influence the function of detoxification, which cause the increase in the susceptibility of~     lung cancer. P53 and MDM2 genes play important roles in the production of tumor-suppression~     proteins and the regulation of transcription factors, which may regulate the growth and the~     apoptosis of cell cycle and influence the susceptibility of lug cancer. The polymorphisms in~     ERCC genes may cause the damage in the DNA repair process which might also cause increase in~     lung cancer susceptibility. The overexpression of epidermal growth factor receptor is highly~     correlated with increasing risk of the non-small cell lung cancers. The overexpression may~     induce the proliferation of cancer cells and the inhibition of the apatosis. Therefore, in~     recent years, EGFR has been widely studied as the new target of the drugs and the~     susceptibility of the lung cancer. In addition,the genetic polymorphisms in drug metabolism~     channel proteins, like OCT2 (organic cation transporter), ATP7A, ATP7B and ABC (ATP-binding~     cassette) transporter may have influence on the metabolism, the efficacy and the toxicity of~     the drugs.~   "
174541|NCT01280435|"~     The trend is changed by a large number of low-cost computers, large-capacity computing power,~     and the rapid advent of network bandwidth. From the Internet to the WWW to Web2.0, the~     technology in addition brings impact on economic, social, and technological, but also on~     medical education about knowledge delivery globally and learning patterns.~      Currently, many scholars start to take the affection of social network seriously. In the~     medical field, ECGpedia is the typical successful example. There are more than 250,000~     members from 188 different countries in the website. On the other hand, the effect of data~     computing and transition improve the development of Gigapixel image presentation. For~     example, users can zoom in and zoom out on GoogleMap. The research team has being worked on~     this kind of search engine on pathology and anatomy slides in past three years. For education~     purpose, students can observe slides by using a virtual microscope directly.~      This research will target on establishing a Clinical Dermatopathology Online Discourse System~     (iSlide). It will combine a virtual microscope platform and a biopsy diagnosis eLearning~     System. This survey will be focused on evaluating of this platform. The object is all interns~     in dermatopathology department at Wan Fang Hospital this semester. All the new physicians can~     learn from experienced experts. Users who have questions can search for help from others via~     this website. They can get assistance by thinking procedure learning model -scheme inductive~     and pattern recognition. In doing so, clinicians and pathologists can discuss with each other~     through this system. It also can improve the education and research development in this~     field.~   "
174554|NCT01280266|"~     The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin~     discoloration, is 5-10% in general population. Often conventional measures such as warming up~     or minimizing exposure to cold are not enough and many patients require treatment with a~     vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil,~     a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.~      Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5~     inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment~     of secondary RP in Korean patients.~   "
174542|NCT01280422|"~     The doctor's overridden rate for Drug-drug interaction (DDI) alert systems was 85-95% in~     foreign and there was more than 90% overridden rate in Taiwan. Why DDI alerts systems which~     spent much time and money to establish could not use medicinal information to increase drug~     safety? One of the reasons which induced to override was that health care thought there were~     too much DDI alerts and high false alerts.~      The difference between DDI alert systems from pharmacists to confirm drug-drug interaction~     was that pharmacists not only confirmed ordering drug at the same time but also checked the~     other drug information such as frequency, rote and refill etc. Therefore, DDI alert systems~     which were established by drug code alone would induce a lot of false alerts.~      In order to study how much false alert rate in drug-drug interactions, this research selected~     most common drug-drug interaction which was antacids and antibiotics. Antacids were most~     self-payment so this research needed to analyze ROCDR (Establishing a Multi-Center,~     Longitudinal, Research-Oriented Clinical Data Repository for Clinical Research). The aim was~     to study how many drug-drug interactions and false alerts from antacids and antibiotics and~     analyze the difference in different department. Finally, proposing advice and assessment for~     building drug-drug interaction alerts system to strength drug information system and increase~     drug safety.~   "
174543|NCT01280409|"~     The purpose of this study is to determine whether the study drug metformin is helpful in~     reducing weight after pregnancy in women with gestational diabetes. This pilot study will~     provide information on how well women are able to take metformin postpartum, whether~     metformin increases weight loss, and whether there are any increased risks of side effects to~     you as a new mother.~   "
174544|NCT01280396|"~     Second-generation antipsychotics (SGAs), including clozapine, are commonly used nowadays as~     treatment for psychosis. There are increasing concerns about their related metabolic~     side-effects over weight gain, risks to cause glucose intolerance and hyperlipidemia, and a~     specific condition known as metabolic syndrome. All these side-effects might be associated~     with the increased risk of cardiovascular diseases and diabetes mellitus.~      This study is to analyze the simple physical measurements (weight and height) and venous~     blood tests (for fasting blood glucose and lipid) results collected routinely since 2008~     (recommended by the local hospital authority as a territory-wide SGAs Monitoring Program)~     from those outpatients receiving SGAs (amisulpride, aripiprazole, olanzapine, paliperidone,~     quetiapine, risperidone and ziprasidone) and/or clozapine, at a local psychiatric outpatient~     clinic in Hong Kong. The investigators hypothesized that there should be differential risks~     on metabolic side-effects amongst these SGAs.~   "
174545|NCT01280383|"~     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA~     delivers assistance to spontaneous breathing based on the detection of the electrical~     activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on~     respiratory muscle unloading critically ill patients.~   "
174546|NCT01280370|"~     Nowadays incisional hernia are primarily repaired using prosthetic meshes. In Switzerland~     such meshes are mainly implanted via open or laparoscopic approach. The differential impact~     of these two types of surgical technique on recurrence rate will be investigated with this~     study.~      With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia~     repair will be investigated prospectively. Hernia recurrence is the main outcome measure.~      Hypothesis:~      Laparoscopic incisional hernia repair is associated with a lower recurrence rate compared to~     open incisional hernia repair.~   "
174547|NCT01280357|"~     Clinical Investigation Protocol for a study designed to determine the equivalence of the~     Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC)~     monitoring during labor. The study will be carried out on subjects in the first and second~     stages of labor.~   "
174548|NCT01280344|"~     Post-operative administration of ipamorelin is expected to reduce time to recovery of~     Gastrointestinal (GI) function in patients who have undergone partial small and/or large~     bowel resection.~   "
174549|NCT01280331|"~     This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12~     mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given~     q6hr for the management of acute moderate to severe postoperative pain for 48 hours following~     bunionectomy surgery.~   "
174550|NCT01280318|"~     The obvious hypothesis is that the application of peri-operative targeted biological agents~     may counteract the tumor growth effect of these circulating factors and improve patient~     outcome~   "
174551|NCT01280305|"~     The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as~     add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.~   "
174552|NCT01280292|"~     Medical management of central hypothyroidism is controversial due to lack of reference for~     evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based~     on T4 levels, measured with variable laboratory methods. Patients who have central~     hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which~     they need replacement therapy such as steroids, testosterone and growth hormone. This~     combined hormone deficiency makes clinical and laboratory evaluation challenging among these~     patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific~     and it might be overlooked due to other hormonal deficiencies. Replacement therapy for~     central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th~     percentile of normal. The goal of our study is to compare the standard results from well~     known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem~     mass spectrometry.~   "
174553|NCT01280279|"~     Few studies have reported the efficacy of repetitive education for behavioral modification as~     the first-line therapy for patients with nocturnal polyuria (NPU). The aim of this study is~     to investigate the efficacy of repetitive education for behavioral modification as the~     first-line therapy in the patients with NPU and to show whether a single education for~     behavioral modification is sufficient for the patients.~   "
174576|NCT01279980|"~     The purpose of this study is to find out whether the use of Painbuster® (a local anaesthetic~     wound catheter) can be used instead of epidurals for patients having bowel surgery in an~     enhanced recovery programme. The investigators want to find out whether or not using this~     device means people need to stay in hospital for less time after surgery.~   "
174577|NCT01279967|"~     To examine whether the arginine depleting drug, ADI-PEG 20, might be effective as a targeted~     therapy in patients with ASS-negative malignant pleural mesothelioma.~   "
174555|NCT01280253|"~     The objective of the study is to identify biochemical predictors of morbidity and mortality~     in patients suffering from hip fracture. For this purpose blood samples are collected~     prehospitally or in the emergency department in patients with a suspected hip fracture.~     During the hospital stay medical history, anesthesiological management recorded. In addition,~     american society of anesthesiology physiological score (ASA), revised cardiac risk index~     (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded  in house,~     after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome will be~     evaluated with logistic regression analysis. Biochemical predictors include pro-brain~     natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. The~     predictive value of the potential markers will be compared to that of ASA, RCRI and POSSUM.~   "
174556|NCT01280240|"~     The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000~     (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced~     anemia.~   "
174557|NCT01280227|"~     Children with Cancer or congenital heart disease (CHD) experience complex, physical,~     psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical~     procedures. To help children cope with their problems and prevent psychological distress, the~     investigators developed SiSom, a support system to help children with cancer or CHD report~     their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer.~      This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the~     following hypotheses: When children use SiSom to report their symptoms and problems, and this~     information is provided to their clinicians in their outpatient consultations:~        -  Children and parents will experience less anxiety.~        -  Children and parents will be more satisfied with the outpatient visit.~        -  There will be greater congruence between children's reported symptoms and problems and~          those addressed by their clinicians as evidenced in documented patient care.~      To better understand the mechanisms by which these effects may occur, the investigators will~     also explore:~        -  Differences between control and experimental groups in patient-provider communication in~          terms of instrumental and affective behaviour, participation, initiative and person~          addressed;~        -  The relationships among outcomes of patient-provider communication, congruence between~          patients' reported symptoms and those addressed by their clinicians and children's and~          parents' anxiety and satisfaction; and how these relationships differ between treatment~          and control conditions.~      Finally, the investigators will investigate time requirements, ease of use and usefulness of~     SiSom by children and clinicians.~      For analyses the investigators will use inferential statistics and qualitative analyses of~     the video-taped consultation sessions. This study will contribute to improving~     patient-centred care for a particularly vulnerable population, and to a better understanding~     of the triadic communication and interactions among child-parent and clinician.~   "
174558|NCT01280214|"~     Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to~     systemic Steroid therapy for patients with active thyroid orbitopathy.~   "
174559|NCT01280201|"~     The incidence of new diagnosed patients with NET of the digestive tract including carcinoid~     and pancreatic islet cells tumors ranges from 2 to 10 per 100,000 in the western Countries~     (Kulke M, Mayer R. N Engl J Med 340:858-868, 1999). Despite of the low incidence, the~     prevalence of these tumors is high because of their relatively long survival estimated in 35%~     at 5 years for those patients with well or moderate differentiated tumors (Yao JC, et al. J~     Clin Oncol. 2008;26:3063-3072). In fact, digestive NETs are the second most prevalent tumors~     derived from the digestive tract after colorectal carcinoma.~      NETs are characterized by abundant vasculature, moreover VEGFR and VEGFR are overexpressed in~     60-84% of the carcinoids and pancreatic islet cells NETs (Zhang et al. Cancer~     2007;109:1478-1486). Other pro-angiogenic factors like the platelet derived growth factor~     (PDGFR) have been also involved in NET progression and development (Chaudhry A, et al.Cancer~     Res 1992;52:1006-12).~      Pazopanib is an oral tyrosine kinase inhibitor of the VEGFR, PDGFR and KIT with a dual~     activity both as an antiangiogenic and also and anti-tumoral agent (Kumar et al. Mol Cancer~     Ther2007;6:2012-2021, Hurwitz et al. Clin Cancer Res 2009;15:4220-4227). Pazopanib seems to~     have a better toxicity profile versus the other antiangiogenic tyrosine kinase inhibitors and~     has already shown activity in several tumor types like renal cell carcinoma (Sternberg et al.~     J Clin Oncol 2009;27:abst. 5021), soft tissue sarcomas (Sleijfer et al. J Clin Oncol~     2009;27:3126-32), hepatocellular carcinoma (Yau et al. J Clin Oncol 2009;27:abst. 3561),~     colorectal cancer (Brady et al. J Clin Oncol 2009;27:abst.4133), and thyroid cancers (Bible~     et al. J Clin Oncol 2009;27:abst. 3521).~      The Spanish Group for Research in Neuroendocrine Tumors (GETNE) group is an active Member~     inside of the GENET group and has a large tradition in clinical trials in NETs. The~     investigators hypothesize that pazopanib may have at least as good activity and better safety~     profile than other VEGFR inhibitors in progressive advanced or metastatic NET tumors derived~     from the digestive tract.~   "
174560|NCT01280188|"~     This is an open-label dose-titration study in Japanese Central Diabetes Insipidus (CDI)~     patients designed to demonstrate the efficacy and safety of orally-disintegrating tablet of~     desmopressin.~   "
174561|NCT01280175|"~     The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite~     beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol~     100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique~     or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the~     standard actuator~   "
174562|NCT01280162|"~     An observational cohort and malaria treatment study in Cambodia.~   "
174563|NCT01280149|"~     The purpose of this study is to determine whether a neuropeptide, substance P, when injected~     along with an allergen, such as ragweed, can reduce allergic reactivity.~   "
174564|NCT01280136|"~     The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually~     transmitted infection (STI), and pregnancy prevention curriculum as a stand alone~     intervention for 8th grade students in a large urban school district. This web-based~     curriculum will be adapted from the computer-based component of an existing successful~     prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include~     critical elements from the IYG classroom component. The primary hypothesis to be tested is:~     (1) students who receive the web-based curriculum will delay sexual activity relative to~     those who receive standard care. The major dependent variable is the proportion of students~     initiating sexual activity (vaginal, oral, or anal sex). Secondary hypotheses will examine~     the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal)~     and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes,~     and perceived norms related to sexual risk-taking behavior. Secondary hypotheses will also~     examine the effect of the intervention on the proportion of students who are sexually active,~     number of times students engage in unprotected sexual intercourse, and students' number of~     sexual partners.~   "
174565|NCT01280123|"~     This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of~     oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and~     futility.~      Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8~     weeks but no more than 8 months, will be randomized to one of two dosages of oral~     pioglitazone (15 mg and 45 mg) or matching placebo.~      The study will measure disease progression by the change in total Unified Parkinson's Disease~     Rating Scale (UPDRS) score between the baseline visit and 44 weeks.~   "
174578|NCT01279954|"~     The purpose of this study is to assess the safety and efficacy of abatacept in the treatment~     of uveitis.~   "
175502|NCT01267942|"~     Null hypothesis; The efficacy of Enhancin]Co-Amoxiclav given as a single intravenous dose at~     induction is not better than a five days oral course of the same given postoperatively in~     reducing postoperative morbidity after adenotonsillectomy.~   "
174566|NCT01280110|"~     BAK is one of the most frequent preservatives in eye drops. BAK is a quaternary ammonium salt~     with surfactant qualities. It can be bacteriostatic or bactericidal depending on the~     concentrations used. It has been shown to be effective against most bacteria with a few~     exceptions, such as Pseudomonas aeruginosa, or picornaviruses. It as been widely used in~     eyedrops, nose sprays, hand and face washes, mouthwashes, spermicidal creams, and in various~     other cleaners, sanitizers, and disinfectants. BAK gained popularity when it was first~     introduced because it also enhances corneal penetration of some drugs by causing epithelial~     separation.~      It is present in several ophthalmic formulations, including most of the antiglaucoma~     medications. If used chronically, BAK has been found to cause ocular surface changes, such as~     dry eye and punctuate keratitis. BAK has also been suggested to promote a break in the blood~     aqueous barrier, which may lead to undesirable consequences, such as uveitis and cystoid~     macular edema. However, this information is controversial. The purpose of this study is to~     evaluate the consequences of BAK on the blood-retinal and blood-aqueous barriers of~     pseudophakic patients receiving BAK-preserved lubricating drops.~   "
174567|NCT01280097|"~     The investigators will perform a prospective, cohort study of 100 older intensive care unit~     (ICU) patients, to investigate the association between sleep disruption and ICU delirium.~   "
174568|NCT01280084|"~     This study aims to measure movements in babies after they are born using an actigraph, a~     wristwatch-sized device worn on the ankle, which works similarly to the device used by~     runners to count the number of steps they have taken. We aim to compare the movements of~     babies whose mothers have received different types of pain relief in labour.~   "
174569|NCT01280071|"~     Veno-arteriolar and veno- arteriolar-myogenic reflexes (VAR and VMR, respectively) are of the~     most important contributors to local vasoregulation.~      In a recent research we showed that VAR is affected in the affected lower limbs of CRPS~     (chronic regional pain syndrome) patients. {Dayan, 2008 1 /id} That is, local venous~     congestion (40 mmHg) results in a decreased blood flow in the affected, sick limb compared~     with its contralateral. The myogenic reflex, however, that is induced by lowering the leg 40~     cm below heart level, which causes both venous and arteriolar congestion, was intact in the~     sick leg. We concluded that the pathophysiology of CRPS might involve a defect in the neural~     reflex between venous and arteriolar vessels. Arteriolar smooth muscle action, on the other~     hand, is intact and might compensate for the overwhelmed VAR.~      Trying to explain the fact that VAR, but not VMR, was different between the affected and~     unaffected limbs, we raise the hypothesis that since VMR is a local vasoregulatory reflex~     composed of two components: the venous and myogenic, opposed to the VAR, the myogenoic~     component of the reflex might compensate for the inappropriate VAR. Many mechanisms that~     might affect vascular muscles may occur, one of them is related to adenosine.~      Adenosine is considered a retaliatory autacoid, whose main function is to protect tissues~     against ischemia. It is a very potent vasodilator. Adenosine is also considered an important~     mediator of ischemic preconditioning, a phenomenon by which an initial brief period of~     ischemia protects the tissue from the damage produced by a subsequent more intense ischemic~     episode.~      Adenosine has a pivotal role in local vasoregulation. In many researches it was shown that~     adenosine contributes to exercise hyperaemia in skeletal muscle. The 'adenosine hypothesis'~     states that blood flow is regulated by interstitial adenosine, released from cardiac or~     skeletal muscle fibers when there is a mismatch between O2 supply and O2 demand. When there~     is insufficient O2 to regenerate ATP, ADP and AMP accumulate leading to adenosine generation.~     By causing vasodilatation, adenosine helps to restore the O2 delivery, reversing the mismatch~     and allowing ATP to be regenerated.~      Adenosine is a naturally occurring ligand of 4 subtypes of G-protein-coupled cell membrane~     receptors (A1, A2A, A2B, and A3) involved in cellular signaling. Dipyridamole produces~     coronary hyperemia by indirectly activating adenosine A2A receptors by inhibiting tissue~     uptake of adenosine and thereby increasing levels of endogenous adenosine.~      Taking all these considerations into account we hypothesize that local vascular reflexes like~     VAR, and eventually VMR are mediated by adenosine. That is, adenosine produced at a constant~     rate in vascular bed contributing to constant blood flow under a wide range of local~     circumstances. A local increase in venous blood flow (as in lower limbs veins during~     prolonged standing) causes adenosine wash out, which leads to local arterial~     vasoconstriction to reduce blood flow to the limb, which is, in fact, the purpose of VAR. if~     our hypothesis turns to be true, then when we will see exaggeration of the reflexes with~     adenosine blockade and vice versa, a decrease its abolishment with adenosine reuptake~     inhibition.~   "
174570|NCT01280058|"~     This phase II trial studies how well carboplatin and paclitaxel with or without viral therapy~     works in treating patients with pancreatic cancer that has come back or has spread to other~     places in the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Viral therapy may be able to kill~     tumor cells without damaging normal cells. It is not yet known whether carboplatin and~     paclitaxel are more effective with or without viral therapy in treating pancreatic cancer.~   "
174571|NCT01280045|"~     The investigators aimed to assess if use of aromatase inhibitors could decrease volume of~     uterine leiomyoma and cause same percentage of adverse effects during its use compared to~     GnRH analogs.~   "
174572|NCT01280032|"~     Vertebral column is the most prevalent location of bone metastases. Besides axial pain,~     vertebral metastases cause pathological fracture and neurological dysfunction by spinal cord~     compression. Although the median overall survival of patients with bone metastases is only~     7-9 month, half of them live longer and will require palliative treatment for their symptoms.~      Treatment options are radiotherapy and /or surgical treatment such as laminectomy,~     vertebroplasty or kyphoplasty. Various studies have shown the superiority of postoperative~     external beam radiotherapy after kyphoplasty in spinal metastases compared to surgery or~     radiotherapy alone. Nevertheless postoperative radiation schedules last 2-4 weeks. Moreover~     many patients present visceral and bone metastases simultaneously and require urgent systemic~     therapy. However, due to potentiated toxicity, concurrent therapy with full dose chemotherapy~     and radiotherapy is rarely possible.~      The investigators have therefore established a novel method for intraoperative radiotherapy~     (IORT) during kyphoplasty which enables immediate stability, sterilization of the metastasis~     and immediate initiation of chemotherapy.~      The kyphoplasty itself is performed according to the standard procedure with some minor~     modifications. In short under general anaesthesia, a bipedicular approach into the affected~     vertebra is chosen with insertion of specially designed metallic sleeves to guide the~     electron drift tube of the miniature X-ray generator (INTRABEAM®). To perform the IORT during~     a kyphoplasty with this device a new applicator was designed. This sterile applicator~     consists of a plastic head, which is needed to attach it to the X-ray source and a stainless~     steel tube. This tube protects the probe from bending. Under fluoroscopic guidance the~     applicator including the drift tube is guided through the metallic sleeves in the vertebral~     body. A dose of 8 Gy in 5 mm distance is delivered. After IORT the INTRABEAM system is~     removed. The kyphoplasty balloon is inflated and PMMA-cement is injected. Afterwards the~     sleeves are removed and the wound is closed as usual.~      Aim of this study is the definition of the maximum tolerable dose (MTD) for IORT during a~     kyphoplasty using specific MTD-criteria and evaluating the effectiveness of this combined~     treatment procedure. To determine the MTD 3 levels with increasing doses are planned:~      8 Gy in 5 mm distance, 8 Gy in 8 mm distance and 8 Gy in 10 mm distance.~   "
174573|NCT01280019|"~     In ventilated patients with acute respiratory failure endotracheal suctioning may lead to~     alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC)~     measurements. Regional distribution of ventilation can be followed at bedside using~     electrical impedance tomography. The investigators hypothesize that a FRC guided recruitment~     strategy, aimed at restoring a baseline FRC value after open endotracheal suctioning,~     improves oxygenation and regional distribution of ventilation. In addition the investigators~     research the impact of such a strategy on the inflammatory response to mechanical~     ventilation.~   "
174574|NCT01280006|"~     The study has been designed to assess the effect of cyclooxygenase inhibition on blood~     pressure, cerebral blood flow, ventilation and renal hemodynamics following chronic~     intermittent hypoxia exposure.~   "
174575|NCT01279993|"~     Purpose: To detect orthoptic changes in patients undergoing photorefractive keratectomy~     (PRK). Method: This interventional case series was performed on 297 eyes of 150 patients who~     were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations~     were performed before and 3 months after PRK. Results: Before PRK, two (1.3%) patients had~     esotropia that remained unchanged postoperatively. However, 3 (2%) patients had distance~     exotropia preoperatively which improved after PRK. Of 12 cases (8%) with preoperative~     exotropia at near, 3 (2%) cases became orthophoric. Six patients (4%) developed postoperative~     near exotropia. A significant reduction in means of convergence and divergence amplitudes~     (P<0.001) and a meaningful increase in mean of near point of convergence (NPC) (P<0.006) were~     noticed after PRK. A reduction of ≥10 PD in convergence amplitude and ≥5 PD in divergence~     amplitude were detected in 10 and 5 patients, respectively. Four patients had an preoperative~     NPC>10 cm which was not changed by the surgery. Out of 9 (6%) patients with baseline~     stereopsis >60 seconds of arc, 2 (1.33%) cases showed an improvement in stereopsis following~     PRK. None of the patients complained of postoperative diplopia. Conclusion: Eye deviation in~     patients undergoing PRK may improve or remain unchanged after operation and postoperative~     deviations can develop following this surgery. Diminishing of fusional amplitude and~     increasing of NPC as well as improving of stereopsis may also happen after PRK. Therefore, a~     preoperative orthoptic examination in patients with any concerning histories and/or motility~     issues on routine exam is recommended before performing PRK.~   "
174590|NCT01279798|"~     This is an expanded access protocol designed to make Lucanix® available to subjects with~     advanced non-small cell lung cancer (NSCLC) who are not eligible for the Phase III Protocol,~     NR001-03. A total of 45 patients will be enrolled into the study.~   "
174579|NCT01279941|"~     Researchers from Oregon Health & Science University have developed a science-based,~     team-centered, scripted peer-taught program for fire fighters improving diet and exercise~     behavior while reducing injury rates and costs. Those investigators are partnering with local~     law enforcement agencies in Oregon and SW Washington to adapt, apply and assess this~     work-based program among a new high risk group to improve the health and safety of law~     enforcement officers (LEOs). Fire fighters' work structure is a natural fit for a~     team-centered format, and teammates' social support appeared to partially mediate the~     intervention's positive outcomes. Although conducive to team formation, LEOs' work lacks the~     established team structure of fire fighters. This proposal will apply the team-centered~     intervention to LEOs and in the process, learn more about teams as vehicles of health~     behavior change, and their relationship with outcomes and other potential mediating variables~     in a multilevel ecological analytic framework.~   "
174580|NCT01279928|"~     This project aimed to explore novel methods of detecting small blood vessel disease in a~     paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold~     capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory~     Blood Pressure Monitoring were used. Each of these techniques investigated different areas of~     small blood vessels around the body.~      It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel~     investigations would be associated with small blood vessel disease and that widespread~     changes to these blood vessels would be detected through associations between the different~     novel investigations.~   "
174581|NCT01279915|"~     A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single~     ascending dose of ASP0456 in non-elderly healthy subjects.~   "
174582|NCT01279902|"~     This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with~     completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I~     or II.~   "
174583|NCT01279889|"~     This study aims to identify women at risk of low blood pressure (hypotension) after the usual~     cesarean anesthetic - a spinal anesthetic. Hypotension may be caused by dehydration. We~     believe we can predict who will get hypotension by using two anesthesia monitors together~     with a passive leg raise (PLR) (legs elevated after a period spent reclining). The PLR will~     cause a shift of blood from the legs to the heart, and the monitors will detect the heart's~     response to tell if a subject is dehydrated. We want to see if these dehydration tests can~     also predict hypotension after a spinal anesthetic.~   "
174584|NCT01279876|"~     The purpose of this study is to determine whether melatonin is effective in the treatment of~     relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying~     drugs.~   "
174585|NCT01279863|"~     The VRI technology provides a radiation free dynamic image of the lung, by using a~     combination of well-known technologies, i.e. acoustic sensors, and a proprietary algorithm.~     The aim of the study is to determine if the VRI examination may contribute to the diagnosis~     and follow up of pneumonia in children, and therefore reduce the number of chest radiographs~     and the exposure to ionizing radiation. Children referred by ED for chest x-ray,for the~     evaluation of pneumonia, will undergo VRI as well. The two modalities will be read~     independently and then the findings will be compared, in order to asses the potential role of~     the VRI to the management of pneumonia in children.~   "
174586|NCT01279850|"~     The objective of this investigation is to evaluate the safety and efficacy of long term use~     with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions~     (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and~     whether an additional treatment outcome investigation and/or a post-marketing clinical study~     is required in the future will be determined.~   "
174587|NCT01279837|"~     In this study supported by an American Cancer Society grant, the investigators are evaluating~     two levels of swallowing exercise intensity on the maintenance of swallowing muscles and~     their function in Head/Neck cancer patients undergoing radiotherapy. Patients in this study~     are randomly placed into different exercise groups and provided with exercises to perform~     daily during their radiation treatment. Their progress, diet management and swallowing~     ability are monitored throughout the treatment period and followed up until 3 months after~     radiation treatment. In addition to the daily treatment details, the patients perception of~     their swallowing ability and concerns about their health and treatment are also measured.~     This clinical trial will help to refine a previously investigated simple exercise package and~     provide a program of intervention that can help prevent medically related complications of~     swallowing difficulty (e.g. pneumonia, dehydration, prolonged tube feeding), and improve the~     ability to eat for patients with head / neck cancer. Ultimately it is hoped that this form of~     exercise therapy will help reduce the costs (personal and financial) to the patient,~     caregivers and community.~   "
174588|NCT01279824|"~     Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the~     treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality,~     in the absence of strong research support. This study aims to investigate the effect of NMES~     therapy for dysphagia upon recovery of swallowing function following stroke. The study will~     follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute~     rehabilitation facility will be clinically screened for dysphagia, and randomized into one of~     three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. All patients~     will be treated for one hour per day for 3 weeks, and their progress and outcome will be~     monitored. The results will add to the preliminary data on the effectiveness of this form of~     swallowing treatment for patients following stroke, and has the potential to enable more~     efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to~     stroke patients, and the community.~   "
174589|NCT01279811|"~     The purpose of this study is to:~        1. Measure the pressure in the spinal fluid surrounding the spinal cord to find out how~          well the spinal cord is being supplied with blood.~        2. Determine how drugs called vasopressors, which are used to control blood pressure~          following SCI (spinal cord injury), influence spinal fluid pressure.~        3. Characterize the severity of an SCI using the levels of specific proteins found within~          the spinal fluid.~        4. Predict how much neurologic recovery may be regained using the levels of specific~          proteins within your spinal fluid.~        5. Identify proteins within the spinal fluid that will help us learn more about what is~          happening after SCI and assist us in developing new treatments for SCI.~   "
174592|NCT01279772|"~     In this study, the investigators propose that the addition of rituximab will lower the risk~     of systemic and local relapses in patients with localized PBL. Patients will be treated with~     6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy~     is strongly recommended, based on the findings of the retrospective IELSG study, but will be~     at the discretion of the treating center.~   "
174593|NCT01279759|"~     Background:~      An estimated 4000 Anterior Cruciate Ligament Injuries (ACL) occur annually in Norway (Granan~     et al., 2004). 1630 primary ACL reconstructions were performed in Norway in 2008 (Norwegian~     Arthroplasty Register, 2009). Approximately 120 of these ACL reconstructions were performed~     at Haraldsplass Deaconess Hospital.~      Physical therapists at our hospital are responsible for postoperative outpatient controls of~     patients with a reconstructed anterior cruciate ligament. A clinical observation is that~     stair walking (especially downstairs) may be problematic up to 6 months after ACL~     reconstruction. One reason may be that the quadriceps muscle is unable to control the knee~     when the subject is walking downstairs, and that the knee is perceived to be unstable. Other~     contributing factors may be pain and swelling.~      It is of interest to know which pre and post operative factors can predict measured and~     patient reported function 6 months after ACL reconstruction. Previous research shows that~     predictive factors for clinical outcome after ACL reconstruction are anterior knee pain~     (Heijne et al., 2009), preoperative electromyography, early postoperative strength (McHugh et~     al., 2002), preoperative quadriceps muscle strength deficits, meniscus injury and pain~     (Eitzen et al., 2009), obesity, smoking and serious chondrosis (Kowalchuk et al., 2009).~      Purpose:~        1. To analyse which pre and post operative factors can predict measured and patient~          reported function 6 months after Anterior Cruciate Ligament reconstruction.~        2. To investigate if there is an asymmetry in step time between the affected and unaffected~          leg during down stairs walking, and if degree of asymmetry decreases during a 6 months~          period post operatively. Further we want to compare step time asymmetry with other~          established outcome measures to investigate sensitivity to change over the observation~          period and also compare the patient group in this study with a control group of healthy~          subjects to see if asymmetry in the patient group after 6 months is still higher than in~          healthy subjects.~   "
174594|NCT01279746|"~     The purpose of this study is to prove that bedside Ultrasound Compression is a useful~     screening tool for the diagnosis of occult deep vein thrombosis in patients presenting to the~     emergency room with hypoxia.~   "
174595|NCT01279733|"~     The main objective of the multi-centered collaborative study is to evaluate the accuracy,~     efficacy and clinical advantages of prenatal diagnosis using microarray analysis as compared~     with conventional karyotyping.~   "
174596|NCT01279720|"~     Adenosine deaminase deficiency is an inherited disorder that results in severe abnormalities~     of the immune system and leaves children unable to fight infection. This trial aims to treat~     adenosine deaminase deficiency patients using gene therapy.~   "
174597|NCT01279707|"~     The treatment of adult B-cell acute lymphoblastic leukaemia (ALL) has progressed considerably~     in the past 3 decades, particularly due to intensification of chemotherapies, improved~     supportive care and the incorporation of stem cell transplantation. However, the maximum~     tolerability of standard chemotherapeutics has been reached in ALL. Using conventional~     chemotherapy, 80-85% of adults with ALL will achieve a complete remission (CR). Unfortunately~     treatment at relapse is generally unsuccessful and rarely results, in long-term survival (7%~     survival at 5 years). Therefore, the investigators are exploring novel treatment strategies~     through the use of monoclonal antibodies (MoAbs) directed at surface antigens on leukaemic~     blasts. Using MoAbs directed against surface proteins on B cells has had excellent results in~     other B-cell diseases such as low and high grade non-Hodgkin lymphomas, without additional~     toxicity. There has also been limited evidence from small studies and case reports of the~     efficacy of MoAbs in ALL.~      This is a Phase I/II study to determine the safety and tolerability of the combination of~     veltuzumab and epratuzumab with intensive chemotherapy in patients with relapsed B-cell ALL.~     A maximum of 51 patients will be treated with a combination of UKALL XII induction~     chemotherapy and the monoclonal antibodies veltuzumab and epratuzumab. Veltuzumab and~     epratuzumab are humanised monoclonal antibodies that target CD20 and CD22 surface proteins,~     respectively. Both of these proteins are expressed on ALL tumour B cells.~      One group of patients will receive modified UKALL XII chemotherapy + veltuzumab; a second,~     modified UKALL XII chemotherapy + epratuzumab and if limited toxicity is found in these first~     2 groups, a third group will receive, modified UKALL XII chemotherapy + both veltuzumab and~     epratuzumab. Patients will be assessed for safety, tolerability and disease response. Safety~     and tolerability will be measured by the number of Dose Limiting Toxicities (DLTs) in each~     group. Disease response will be measured by the microscopic appearance of patient bone marrow~     samples at day 29, and by molecular tests for tumour cells in bone marrow.~   "
174598|NCT01279694|"~     Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients~     with multiple myeloma. Nine: University Hospital of Nantes, University Hospital of Nancy,~     University Hospital of Lille, University Hospital of Tours, department Hospital of La Roche~     Sur Yon, University Hospital of Reims, University Hospital of Clermont-Ferrand, University~     Hospital of Toulouse, University Hospital of Dijon Newly diagnosed symptomatic Multiple~     Myeloma > 65 years. Treatment comprises an initial phase consisting of nine 6-week cycles of~     Carfilzomib on Days 1, 2, 8, 9, 22, 23, 29, 30 (carfilzomib is administered at 20 mg/m2 on~     Days 1 and 2 of the first cycle and 20, 27, 36 or 45 mg/m2 thereafter) followed by a 12 day~     rest period (42-day cycle), in combination with oral Melphalan 9 mg/m² and oral prednisone~     60mg/m², both on days 1 to 4.~      Phase I: Identification of Maximum Tolerated Dose (MTD)~      Carfilzomib will be administered at a dose of 20mg/m² for all doses to the first cohort of 6~     patients. If dose-limiting toxicities (DLTs) occurred in fewer than 2 of these patients, the~     next cohort of 6 patients (cohort 2) will receive a dose of 20/27 mg/m² where the 20 mg/m²~     dose is administered on Day 1 and 2 of Cycle 1 only and then 27 mg/m² for all subsequent~     doses. If DLTs occurred in fewer than 2 of the patients in cohort 2, the third cohort of 6~     patients will receive a dose of 20/36 mg/m² where the 20 mg/m² dose is administered on Day 1~     and 2 of Cycle 1 only and then 36 mg/m² for all subsequent doses. If DLTs occurred in fewer~     than 3 of the patients in cohort 3 the fourth cohort of 6 patients will receive a dose of~     20/45 mg/m² where the 20 mg/m² dose is administered on Day 1 and 2 of Cycle 1 only and then~     45 mg/m² for all subsequent doses. If at any time during cycle 1 of a dose cohort, ≥ 2~     subjects experience a drug-related DLT, the MTD will have been exceeded, additional~     enrollment within the cohort will cease, and dose escalation will stop. The MTD will be~     defined as the dose level below which DLT is observed in ≥ 33% (i.e. ≥ 2 of 6) subjects in a~     cohort. The following are defined as DLTs:~        -  Any hematologic toxicity of grade 4 intensity or preventing administration of 2 or more~          of the 8 carfilzomib doses of the first treatment cycle except a) grade 4~          thrombocytopenia without bleeding lasting ≤ 7 days or b) grade 4 neutropenia lasting ≤ 7~          days~        -  Grade ≥ 3 febrile neutropenia~        -  Grade ≥ 3 gastrointestinal toxicities (except for grade ≥ 3 nausea/ vomiting if the~          patient had not received adequate antiemetic prophylaxis)~        -  Any other grade ≥ 3 nonhematologic toxicity considered related to CMP by the principal~          investigator.~        -  Grade ≥ 3 peripheral neuropathy persisting for more than 3 weeks after discontinuation~          of study drugs.~      Adverse events (AEs) will be graded according to National Cancer Institute Common Terminology~     Criteria for Adverse Events (NCI CTCAE, version 4.0). MTD determination will be based on~     occurrence of DLTs during the first induction treatment cycle only.~      Phase II: Expanded Cohort. After identification of the MTD, it is planned for the dose cohort~     to be expanded to include up to a total of 20 patients treated at the MTD for the phase II~     part of the study. A full treatment course is the same as for phase I: nine 6-week cycles of~     CMP.~      PRIMARY ENDPOINT Phase I: MTD of combination Phase II: Overall response rate [(ORR),~     consisting of complete response (CR), very good partial response (VGPR), and partial response~     (PR) SECONDARY ENDPOINTS Safety and tolerability of CMP Clinical benefit response [(CBR = ORR~     + minimal response (MR)], Progression-free survival (PFS), Duration of response Overall~     survival (OS). Safety data analysis will be conducted on all subjects receiving at least one~     dose of study treatment. Analyses will consist of data summaries for reported AEs. The number~     and percentage of subjects experiencing one or more AEs will be summarized by dose,~     relationship to study drugs, and severity. AEs will be coded using MedDRA terminology.~      Disease Response Analyses: Overall response rate (ORR = CR + VGPR + PR) to treatment will be~     measured using the International Myeloma Working Group (IMWG) criteria. Clinical benefit~     response (CBR = ORR + MR) will be determined using minimal response (at least 6 weeks~     duration) as defined by the European Group for Blood and Marrow Transplant (EBMT). The~     distribution of subjects by response category will be made overall and by dose cohort.~     Time-to-event endpoints will be evaluated with the use of the Kaplan-Meier method and plots~     will be provided. Analysis of time-to-event outcomes will be performed for the overall~     sample.~   "
174599|NCT01279681|"~     This randomized phase III trial studies how well combination chemotherapy plus bevacizumab~     with or without oxaliplatin works in treating older patients with colorectal cancer that has~     spread to other places in the body. Drugs used in chemotherapy work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal~     antibodies, such as bevacizumab, may block tumor growth in different ways by targeting~     certain cells. Bevacizumab may also stop the growth of cancer by blocking blood flow to the~     tumor. It is not yet known whether combination chemotherapy plus bevacizumab is more~     effective with or without oxaliplatin in treating colorectal cancer.~   "
174600|NCT01279668|"~     Persistent cough is a common symptom, accounting for about 20% of referrals to outpatient~     chest clinics. Most coughs are caused by self-limiting viral infections such as the common~     cold. However, 1 in 4 people with a viral infection develop a persistent cough, which can go~     on for several weeks. Whooping cough is a common cause of persistent cough in young people~     and adults. Although the whooping cough vaccine gives lifelong protection against severe~     infection, it does not appear to give such long-term protection against milder infections,~     which can make someone cough for many weeks. There are currently no proven efficacious~     treatments for persistent cough following either a viral infection or infection with whooping~     cough.~      Montelukast is a medication which is already licensed for the treatment of asthma. It works~     by blocking the action of chemicals called leukotrienes, which make the airways of people~     with asthma inflamed and sensitive. There is strong evidence to suggest that leukotrienes are~     also involved in causing persistent cough following viral or whooping cough infection.~     Montelukast may therefore also help settle persistent coughs in these settings.~      Over 18 months, we will recruit patients aged 16-49 years with a cough lasting 2-8 weeks from~     general practices in England. An oral fluid sample will be taken from each participant to be~     tested for whooping cough. Participants will be randomly allocated to receive a 28-day course~     of montelukast or placebo tablets and asked to complete a daily cough diary for two weeks.~     They will be assessed after two weeks by their GP (face-to-face) and after four weeks by~     another member of practice clinical staff (telephone). Some participants will be given a~     24-hour cough monitor to wear on study entry and at two-week follow-up. This study will be~     funded by the National Institute for Health Research's School of Primary Care.~   "
174601|NCT01279655|"~     In the current study the researchers will firstly investigate whether a bimanual coordination~     training protocol (20 min/day, for 8 consecutive weeks) correlates with changes in white~     matter architecture and improved upper-limb functionality in patients with multiple~     sclerosis. Secondly, the researchers predict that motor learning is more efficient when it is~     combined with anodal transcranial direct current (tDCS) stimulation on the left primary motor~     cortex.~   "
174631|NCT01279265|"~     This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen~     A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with~     Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to~     compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of~     intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number~     of white blood cells in the large intestine (fecal calprotectin). The investigators predict~     that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an~     important component of the neonatal intestinal microbial community and reduce fecal~     calprotectin.~   "
174602|NCT01279642|"~     Aimed to compare the success in the peripheral intravenous puncture (PIP), progression and~     placement of PICC in children, according to the use of Doppler vascular ultrasound (DVUS) or~     traditional method; to identify the influence of the DUVS in the time expended to PICC~     placement. Methods: Clinical, randomized and controlled trial conducted after ethical merits~     of research endorsement and the obtaining of consent for those responsible for the children.~     The sample, calculated in 42 PICC to obtain a power of 0,85, was distributed randomly into~     two groups, experimental group (EG) and controlled group (CG). To the statistical analyzes~     Pearson Chi-square, Fisher's Exact Tests, Generalization of Fischer's Exact and Mann-Whitney~     tests was applied (5%). Of the 42 catheters, 21 (50.0%) were implemented in EG and 21 (50.0%)~     in CG. The PIP was obtained in the first attempt in 90.5% of the punctures of the EG and in~     47.6% of the GC, (p=0.003). PICC were implanted successfully in 18 (85.7%) children of GE and~     11 (61.1%) of CG (p = 0.019). The median of the time spent to the procedure was significantly~     higher (p=0.001) in CG (50 minutes) when compared to EG (median 20 minutes).~   "
174603|NCT01279629|"~     The purpose of this study is:~      To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis.~      - Population:~      50 patients will be selected from both sexes, healthy, between 18 and 65 years with a~     clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of~     inclusion and exclusion.~   "
174604|NCT01279616|"~     Majority of patients who are eligible for allogeneic HSCT for cure of severe sickle cell~     disease lack a matched family donor. This study aims for cure of sickle cell disease by~     performing unrelated donor (outside family) allogeneic HSCT. Donors or unrelated cord blood~     units will be selected from the NMDP database. It is designed to estimate the safety of a~     novel reduced toxicity, yet an immunosuppressive and myeloablative preparative regimen. This~     is meant for patients <21 years old who have severe complications from sickle cell and do not~     have matched sibling donors in the family to undergo stem cell transplant. Patients will~     undergo transplant using unrelated donor stem cells after receiving the protocol therapy.~     They will be followed for 1 year to monitor for engraftment of donor cells and complications~     like graft versus host disease (GVHD), infections and death.~   "
174605|NCT01279603|"~     This clinical trial is about testing GO-203-2c, which is a newly discovered compound that~     binds to an oncoprotein (a cancer causing protein) called MUC1 (which is over-expressed in~     many cancers). By binding to MUC1, GO-203-2c eventually causes tumor cell death in laboratory~     studies.~      This study is being done to:~        -  Test the safety of GO-203-2c and see what effects (good and bad) it has on you and your~          cancer~        -  Find the highest dose of GO-203-2c that can be given without causing bad side effects~        -  Examine how much GO-203-2c is in the blood at certain times after it is given and how~          quickly the body gets rid of it~        -  Observe whether there is any effect of GO-203-2c on the size and activity of cancer in~          your body~   "
174606|NCT01279590|"~     The purpose of this study is to assess the incidence of statin-associated myalgia (SAM) with~     treatment with PPD10558 versus atorvastatin in patients previously intolerant to statins.~      To assess the safety and tolerability of PPD10558 compared to atorvastatin in patients~     previously intolerant to statins.~   "
174607|NCT01279577|"~     This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland,~     only.~      This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO~     suspension vs. placebo for the induction of remission in Crohn's disease.~   "
174608|NCT01279564|"~     Airway management is one of the most important tasks facing the physician, especially the~     anesthesiologist. Fast and correct performance of endotracheal intubations done as normal~     routine in the operating room, but can save life everywhere.~      To make intubation easier, several newly designed tubes and laryngoscopes are developed and~     tested every year. Their performance is evaluated subjectively by the acting~     anesthesiologist, and by using objective parameters such as speed of intubation, the force~     applied during laryngoscopy , or catecholamines secretion during intubation as a stress~     parameter . The studies set for testing these parameters lead to establish accepted~     indications for the treatment of the airway in cases of anticipated and unanticipated~     difficult airway.~      In the present study we will compare the performance parameters of intubation using Etview~     Tracheoscopic Ventilation Tube - TVT to the standard tube, of which most of daily intubations~     are carried with. The Etview TVT is similar to the standard endotracheal tube; its outer~     dimensions and material is exactly as the standard tube, the difference is only the inner~     fiber of the camera.~   "
174609|NCT01279551|"~     This study wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the~     postoperative pain related to anorectal spasm (anismus) while performing a stapled~     haemorrhoidopexy.~   "
174610|NCT01279538|"~     The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD),~     safety and tolerability of ASKP1240 when administered to subjects who received a de novo~     kidney transplant.~   "
174611|NCT01279525|"~     The purpose of this study is to determine the effectiveness of a multifactorial intervention~     program to prevent falls among the elderly as compared to a brief intervention.~   "
174612|NCT01279512|"~     This study is a prospective randomized clinical trial to compare the endocrine and metabolic~     effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women~     with PCOS~   "
174613|NCT01279499|"~     The objective of this prospective randomized clinical study was to compare anesthesia, in~     morbidly obese patents (BMI >50) who underwent BPD-RYGBP with either sevoflurane or propofol~     with remifentanyl.~   "
174614|NCT01279486|"~     Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to~     the UK trial centre.~      Volunteers will be required to use the Clearblue Pregnancy Test according to the product~     instructions, and provide a urine sample from the same void.~      Trained technicians will conduct a second test from the urine sample.~   "
174615|NCT01279473|"~     This study will investigate if nilotinib provides an improved safety and efficacy profile~     over that seen in patients receiving Imatinib.~   "
174616|NCT01279460|"~     This study aimed to investigate in a cohort with chronic kidney disease the longitudinal~     relationship between aortic stiffness and renal function and mortality.~   "
174617|NCT01279447|"~     The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve~     blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving~     long term outcome scores after knee arthroscopy.~   "
174618|NCT01279434|"~     Nonalcoholic fatty liver disease (NAFLD) is a spectrum of hepatic pathology, ranging from~     simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a~     more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as~     infiltration of inflammatory cells. Since, both vitamin E and PTX has been found to improve~     NASH when used alone, a combination of these two should be expected to give better results~     because of targeting two different pathogenetic mechanisms (cytokines amplification and~     oxidative stress) in NASH patients. This will be open labelled, prospective, randomized~     study. The diagnosis of NAFLD will be made on the basis of Ultrasonographic findings~     suggestive of fatty liver and presence of insulin resistance or features of metabolic~     syndrome. Subsequently histologic confirmation of the diagnosis of NASH will be made in all~     cases.~   "
174619|NCT01279421|"~     This project will first increase the accessibility and acceptability of rapid HIV testing in~     health clinics located in or near four low-income communities in San Salvador, El Salvador.~     The investigators will use crack users' social networks and small incentives, as recommended~     by the CDC, in collaboration with the Salvadoran Ministry of Public Health and Social~     Assistance (MSPAS) to encourage crack users to receive HIV testing. The second part of the~     intervention consists of training 8 Peer Leaders to recruit and lead a Peer Network~     Intervention among 400 crack users to change norms supporting HIV protective behaviors. The~     intervention will include monthly meetings open to crack using and non-crack using community~     residents to reinforce HIV risk reduction skills, and discussion of other topics related to~     HIV such as illicit drug use and interpersonal violence and community-wide HIV awareness~     events. Our hypothesis is that these two intervention features will singly, and in~     combination, reduce HIV risk behaviors among Salvadoran crack users.~   "
174620|NCT01279408|"~     The aim of the study is to assess current practice within PROP & lung teams, for treating~     asymptomatic patients with centrally located non-small cell lung cancer (NSCLC), and to~     observe outcomes for those patients receiving immediate or deferred RT. This is a prospective~     cohort trial. Patients will be managed by immediate radiotherapy (RT) or a deferred approach~     according to physicians' individual current clinical practice. Baseline and follow-up data~     collection will be structured to focus on patient-reported measures to describe clinical~     outcomes in the two management groups. Indications for prescribing RT and dose fractionation~     schedules will also be collected. A new intervention will not be introduced during this~     trial. Instead, a follow-up regimen will be offered to both groups of patients, so that RT~     can be offered to the deferred group of patients if/when symptoms develop, and we can monitor~     symptoms/toxicities and QoL in both groups of patients.~   "
174621|NCT01279395|"~     We hypothesize that administration of anti-inflammatory medications such as celecoxib,~     naprosyn and diclofenac will cause changes in the blood plasma and white blood cells of~     patients such that they will be less able to efficiently process cholesterol.~   "
174622|NCT01279382|"~     In this trial, the effects of two psychological interventions - i.e. hypnotherapy and~     relaxation training - are compared with care as usual in IBS treatment. The investigators~     hypothesized that hypnotherapy is most effective in reducing complaints in IBS.~   "
174623|NCT01279369|"~     The purpose of this study is to determine if the presence of fetal fibronectin in the~     cervicovaginal secretions of pregnant patients with minor maternal trauma predicts impending~     preterm delivery due to abruptio placenta.~   "
174624|NCT01279356|"~     Liver diseases such as non-alcoholic fatty liver disease (NAFLD), alcoholic liver disease~     (ALD) and viral hepatitis have the potential to progress to cirrhosis and finally~     hepatocellular carcinoma (HCC). Early diagnosis and treatment of liver diseases is important~     since progression is likely and is associated with significant morbidity and mortality.~     However, in daily clinical practice no specific and non-invasive biomarkers are used for the~     diagnosis and follow-up of patients with liver diseases. It is known that patients with liver~     diseases produce compounds that can be excreted in breath as a consequence of metabolic~     processes, inflammation and/or oxidative stress. These are called volatile organic compounds~     (VOCs). Analysis of VOCs in exhaled air has been reported to provide valuable information in~     patients with chronic obstructive lung disease (COPD) and inflammatory bowel disease (IBD).~     Also, in patients with liver disease, exhaled VOCs have been detected.~      The investigators hypothesize that analysis of VOCs in exhaled air of patients with liver~     diseases can be used for diagnosis and follow-up.~   "
174625|NCT01279343|"~     The purpose of this study is to compare the efficacy of the combination of the supracervical~     foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We~     hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter~     induction to delivery time.~   "
174626|NCT01279330|"~     The propose of this study is to assess the effect of general practitioner's involvement in~     the stimulus invitation letter in colorectal cancer screening compared to sending the patient~     home test (stimulus 2 of reference as contained in the specifications).~   "
174627|NCT01279317|"~     The main objective of this study is to assess the acute effect of co-ingested vinegar on~     postprandial plasma glucose levels in type 2 diabetes patients.~   "
174628|NCT01279304|"~     The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in~     cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with > 3 pathologic~     axillary nodes on imaging) breast cancer patients, treated with neoadjuvant chemotherapy,~     breast surgery, and radiotherapy that is protocolized based on the pathology findings after~     chemotherapy and definitive surgery (ypTNM stage).~   "
174629|NCT01279291|"~     This is a two-part, Phase 1, open-label, multicenter, dose escalation study of KHK2866 as~     monotherapy in patients with advanced solid tumors, and in combination with chemotherapy in~     subjects platinum-sensitive and platinum-resistant ovarian cancer.~   "
174630|NCT01279278|"~     The propose of this study is to assess the effect of general practitioner's involvement on~     first patients' solicitation in screening for colorectal cancer by testing for faecal occult~     blood (FOBT).~   "
174632|NCT01279252|"~     The purpose of this study is to evaluate whether patients with previously untreated, early~     stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis~     that occult bacterial infections are involved in the induction and maintenance of CLL.~   "
174636|NCT01279200|"~     The purpose of this study is to investigate monitoring methods during ovulation induction~     cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction~     cycles with letrozole can be done with a variety of methods, the two most commonly utilized~     are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle~     follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add~     extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).~   "
174637|NCT01279187|"~     Good bone healing and bone build-up are necessary for the success of dental implants.~     Research in animals and humans has shown that a drug, called Forteo, can increase bone~     build-up and bone strength over time. Forteo has been approved by the Food and Drug~     Administration (FDA) for use in patients with a condition where bone is broken down and~     weakened, called osteoporosis. The investigators do not know, however, whether Forteo is~     effective for use in humans for improving bone healing after implant placement, and whether~     it will have the same bone-building and bone-strengthening effects as for patients with~     osteoporosis. This research study is being done to learn what effect 7 weeks of treatment~     with Forteo will have on bone build-up and strengthening of bone for patients receiving~     implants.~   "
174638|NCT01279174|"~     Osteoarthritis (OA) is the most common degenerative arthropathy. Load-bearing joints such as~     knee and hip are more often affected than spine or hands. The prevalence of gonarthrosis is~     generally higher than that of coxarthrosis.~      Because no cure for OA exists, the main emphasis of therapy is analgesic treatment through~     either mobility or medication. Non-pharmacologic treatment is the first step, followed by the~     addition of analgesic medication, and ultimately by surgery.~      The goal of non-pharmacologic and non-invasive therapy is to improve neuromuscular function,~     which in turn both prevents formation of and delays progression of OA. A modification of~     conventional physiotherapy, whole body vibration has been successfully employed for several~     years. Since its introduction, this therapy is in wide use at our facility not only for~     gonarthrosis, but also coxarthrosis and other diseases leading to muscular imbalance.~   "
174639|NCT01279161|"~     The project aims at assessment of the effect of the FTO gene polymorphism and the type of~     treatment on the development of overweight/obesity and features of metabolic syndrome in~     children with type 1 diabetes.~      Gene polymorphism including some genetic variants may predispose to the development of~     cardiovascular diseases and their complications. The A allele of the FTO gene predisposing to~     obesity occurs in approximately 40% of the European population and each copy of this allele~     can increase BMI by 0.1 Z-score i.e. by 0.4 kg/m2. Insulin therapy in diabetic patients may~     result in excess body weight gain. Therefore we need studies involving large groups of~     children and assessing cardiovascular risk factors in type 1 diabetes along with their~     genetic associations.~      Patients: The study will include 1500 children with type 1 diabetes, aged 6-18 years.~     Reference group will be made of 1500 children in whom type 1 diabetes was excluded. The~     following variables will be assessed in the treatment group: 1) Anthropometric data and~     questionnaire data: age, sex, body height and weight, body mass index (BMI), waist and hip~     circumferences, arm and thigh circumferences, family history of overweight/obesity, type 1 or~     2 diabetes or cardiovascular disease, 2) Primary disease characteristics: age of the disease~     onset, treatment regimen, mean daily insulin consumption per kg body weight, brands of~     insulin products, glycated haemoglobin, BMI from the first 3-6 months following diabetes~     onset, diet, conversion of these data into actual and ideal calorie intake 3) Laboratory data~     - lipid profile and blood pressure (average of three measurements). Methodology: Gene~     polymorphism analysis in the extracted DNA will be made with the real-time PCR method using~     TaqMan 7900 HT by Applied Biosystems. Correlations between the FTO gene polymorphism and~     clinical variables such as BMI (including BMI increase since the disease onset), body weight~     and height, waist and hip circumferences, arm and thigh circumferences, and blood pressure~     will be assessed by a professional statistician with a specially dedicated software. Moreover~     parameters such as diet and metabolic control will be assessed. As regards insulin therapy~     the following variables will be analysed: insulin injection device, therapy regimen~     (intensive versus functional; brands and types of insulin products: human insulin versus~     insulin analogue), consumption of insulin. All of the above listed variables will be~     correlated with the genotypes found in the gene polymorphism analysis. The study has been~     approved by Bioethics Committee of the Medical University in Białystok.~      Results: The authors of the project expect that the effect of the FTO gene polymorphism on~     overweight/obesity and features of metabolic syndrome in children with type 1 diabetes will~     be shown. Moreover the project will enable assessment of the effect of the therapeutic~     regimen, including the type of insulin product, on body weight increase in the course of type~     1 diabetes treatment in the context of the FTO gene polymorphism. Confirmation of the above~     associations and identification of a group at risk of excess body weight increase in the~     course of insulin therapy may help physicians, parents and patients to avoid this~     complication. Therefore clinical benefit of this project will include identification - based~     on the genetic assays results - of a group of type 1 diabetic children particularly likely to~     develop overweight, obesity and other cardiovascular risk factors.~   "
174640|NCT01279148|"~     This prospective, randomized, controlled, parallel-design trial will compare the use of~     electromagnetic tracking and image guidance during biopsy/ablation procedures verses the~     typical standard or conventional image guided procedure alone (control). US~     ultrasound-guided biopsies/ablations with or without CT computed tomography- imaging will~     be used to complete the procedures in either the CT suite or a procedure room, at the~     discretion of the physician, and according to normal local practice patterns.~   "
174641|NCT01279135|"~     The study tests Tomtherapy based Image Guided Radiation against conventional radiation~     techniques for it's ability to reduce long term small bowel toxicity.~   "
174642|NCT01279122|"~     The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed~     in your eye.~   "
174643|NCT01279109|"~     The purpose of this study is to examine whether we can use social networks to spread health~     information and health behaviors during pregnancy to prevent excessive gestational weight~     gain.~   "
174644|NCT01279096|"~     The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited~     Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with~     etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and~     safety of this combination regimen to treat children with high risk relapsed or refractory~     acute lymphoblastic leukemia (ALL).~   "
174645|NCT01279083|"~     To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects~     with primary open-angle glaucoma or ocular hypertension.~   "
174646|NCT01279070|"~     The purpose of this study was to develop an integrative intervention for schizophrenia taking~     into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of~     our cognitive remediation group training: Problem Solving and Cognitive Flexibility training~     (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We~     hypothesized that training executive function and metacognition would allow us to achieve~     improvements in neurocognition, functioning and psychiatric symptoms of patients with~     schizophrenia.~   "
174647|NCT01279057|"~     This study will compare the safety and efficacy of a generic Fluticasone Furoate (Lek~     Pharmaceuticals ) Nasal Spray to the reference listed drug in the treatment of seasonal~     allergic rhinitis. Additionally both the test and the reference formulations will be tested~     for superiority against a placebo nasal spray.~   "
174648|NCT01279044|"~     The purpose of this study is to determine if persons randomized to receive adapted~     Personalized Cognitive Risk-reduction Counseling (PCC) will report greater reductions in~     unprotected anal sex behavior compared with persons who do not receive Personalized Cognitive~     Risk-reduction Counseling (PCC).~   "
174649|NCT01279031|"~     The purpose of this study is to look at the outcomes of your vision after your cataract~     surgery based on two different types of equipment that will be used during your surgery.~   "
174650|NCT01279018|"~     Breast cancer treatment is for many patients followed by sequelae, such as persistent pain,~     sensory disturbances, lymphedema and reduced physical function. These undesired consequences~     of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory~     disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients.~     Development of persistent pain after breast cancer treatment, involves a complex~     pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors~     for the development of persistent pain after breast cancer treatment have been identified;~     young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a~     well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this~     nationwide study is to retrospectively examine a cohort of breast cancer patients treated~     with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of~     persistent pain and other sequelae.~   "
174651|NCT01279005|"~     Four focus groups , each of 10-15 males, ages 20-50 years old, MSM will be conducted by a~     medical sociologist. Two groups will be HIV negative participants and two groups of HIV~     positive MSM. Every group will meet for two hours. The focus group will be recorded and the~     collected data will be processed further for evaluation and extraction of the relevant~     information.~      The volunteers will sign an inform consent prior to entrance to the study.~   "
174655|NCT01278953|"~     The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing~     catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be~     randomized for treatment with either the TactiCath catheter or another ablation catheter with~     no contact force sensing capability. Patients will be followed for 12 months to compare the~     incidence of serious adverse events and freedom from recurring, symptomatic AF between the~     two study arms. Additional measures of treatment success including quality of life,~     recurrence of asymptomatic AF and procedural efficiency will also be studied.~      A second phase of the study will treat up to 50 non-randomized subjects with a new version of~     the device under the same protocol.~   "
174656|NCT01278940|"~     PRIMARY OBJECTIVES: Determination of safety and toxicity of vaccination with patients` tumour~     mRNA transfected DCs .~      SECONDARY OBJECTIVES:Determine immunological response to the vaccine (induction of specific~     T-cell response) and assessment of tumour response~   "
174657|NCT01278927|"~     This is a Phase III, randomized, unblinded, multicenter, prospective comparative study. The~     purpose of this study is to test whether exercise or stress management training delivered to~     autologous and allogeneic hematopoietic cell transplantation (HCT) patients prior to~     transplantation can improve functional status and the transplant experience.~   "
174658|NCT01278914|"~     PRIMARY OBJECTIVES:~      Determination of safety and toxicity of vaccination with mRNA transfected DC (based on blood~     samples, and adverse events).~      SECONDARY OBJECTIVES:~      Determine immunological response to the vaccine (induction of specific T-cell response) and~     assessment of tumour response.~   "
174659|NCT01278901|"~     STUDY PROTOCOL:~      The study will include 30 patients ages 18-80y that had a gastroscopy for various reasons.~     The patients should not be on PPI therapy . If during the gastroscopy there are some~     pathologies that require a second look endoscopy after some weeks of therapy (ulcers or~     esophagitis), the investigators will repeat the gastroscopy within a month.~      During the first gastroscopy a biopsy will be taken for histological examination and for a~     rapid urease test and an urea breath test will be done soon after the procedure.~      If one of the tests is positive the investigators postulate that the Helicobacter pylori is~     actually present.~      After the gastroscopy the patient is given a full dose of PPI (as indicated) and helicobacter~     tests are repeated in the next endoscopy (under PPI therapy) . Any positive test that become~     negative in the second endoscopy is considered false negative.~   "
174660|NCT01278888|"~     Is thoracoscopic surgery better than traditional open surgery for lung cancer?~      Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic~     than traditional open surgery for lung cancer but this has never been documented in a~     randomized trial. Some surgeons hesitate to use VATS because it is technically more~     demanding, others question if the two methods are oncologically equal. Regardless, VATS has~     been implemented as a routine method for lung cancer surgery several places around the world~     including Odense University Hospital. The investigators have launched the first randomized~     controlled trial in the world comparing the two surgical methods to investigate any~     differences in length of hospitalization, postoperative pain, life quality within the first~     year, and health economical aspects.~      The investigators include patients with stage I and II lung cancer, and randomize between~     VATS and open surgery in a design where both the patient and doctors doing general rounds in~     the ward are blinded until discharge because the dressing on the surgical wound is identical,~     regardless of the surgical method. The surgeon cannot influence clinical decisions including~     time to discharge, which is decided by other specialist surgeons. Pain evaluation is~     performed 6 times daily using the VAS-score, life quality is evaluated continuously during~     the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the consumption of~     analgetics in both groups are monitored via the national prescription database.~      Parallel to this trial a similar clinical study, which is also the first of its kind in the~     world, has been launched for patients with lung cancers not eligible for VATS. They are~     randomized between the two traditional open surgical methods (anterolateral and~     posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds~     until discharge from hospital, and endpoint are similar in the two studies.~      250 patients will be asked to participate in each study - so far, 91 patients has been~     randomized and patient accrual is beginning soon at Skejby University Hospital,Denmark in~     collaboration with surgeons from department of thoracic surgery.~   "
174661|NCT01278875|"~     High density lipoproteins (HDL) have many effects that protect against cardiovascular~     diseases. In an acute heart attack (acute coronary syndrome -ACS), HDL change in composition~     and structure, reflecting the inflammatory environment that accompanies an ACS. The~     investigators will examine the function of HDL during an ACS and again when the patient has~     recovered.~   "
174662|NCT01278862|"~     Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided~     Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled~     using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand~     fabricated porcelain covering.~   "
174663|NCT01278849|"~     This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v.~     administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying~     degrees of hepatic impairment. The study will be carried out in cancer volunteer patients~     (utilizing controls with normal hepatic function) who will be assigned to four hepatic~     impairment groups according to their pre-dose (Day-1) and total bilirubin level. The study~     will consist of two phases, a (Core Phase) that will evaluate the pharmacokinetics of a~     single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired~     hepatic function, and compared to controls with normal hepatic function. The assessments will~     be done on the safety and tolerability of that single dose in adult cancer patients with~     impaired hepatic function and compared to controls with normal hepatic function. The~     Extension Phase will consist of assessing the safety and tolerability of ASA404 at the same~     three doses in combination with a sponsor-approved taxane-based regimen in adult cancer~     patients with impaired hepatic function and compared to controls with normal hepatic~     function.~   "
174664|NCT01278836|"~     The purpose of this study is to determine the effects of fasciocutaneous flaps for leg~     defects.~   "
174665|NCT01278823|"~     The purpose of this study is to determine the effects of bariatric surgery on blood sugar~     control and underlying mechanisms that contribute to type 2 diabetes in men and women with a~     BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y~     gastric bypass operation or intensive medical, dietary and exercise management.~   "
174666|NCT01278810|"~     To assess safety, tolerance and PK profile of different doses(50mg,100mg,200mg,300mg, 400mg,~     500mg,QD)of Icaritin in advanced breast cancer Patients in China~   "
174667|NCT01278797|"~     This study will be an open-label, randomized, two-treatment, two-period, two-sequence~     crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer~     Ingelheim Pharma GmbH & Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination~     tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).~   "
174668|NCT01278784|"~     The dry eye syndrome DES is a highly prevalent ocular disease, in particular in the elderly~     population. One mainstay of therapy for patients suffering from DES is the use of topically~     administered lubricants. However, despite many efforts, no ideal formulation has yet been~     found.~      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for~     treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with~     favourable biological properties such as high biocompatibility and low toxicity.~     Additionally, the new formulation comprises N-acetylcysteine, which has been used in~     ophthalmology because of its mucolytic properties for several years. Based on theoretical~     considerations, one can hypothesize that the new chitosan derivative may show an increased~     adhesion to mucins of the ocular surface and may therefore be particularly beneficial in~     reducing the symptoms associated with DES. We have recently shown in a phase I trial that~     single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy~     subjects. However, due to the fact that intraocular pressure has been measured as one of the~     main safety variables, topical anesthesia was necessary. Thus, the data about local ocular~     discomfort after administration are limited. This trial seeks to investigate whether single~     instillation of chitosan-N-acetylcystein leads to ocular discomfort such as burning and~     stinging.~   "
174669|NCT01278771|"~     This is a retrospective study. The investigators shall review the angiography data of 1200~     consecutive cardiac catheterizations of children and babies with CHD (Congenital Heart~     Disease) since 1998 till now.~      Coronary artery origin and course will be evaluated in relation to the morphologic cardiac~     anomalies.~      Coronary artery anomalies will be described and statistical analysis will be performed.~   "
174670|NCT01278758|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in~     patients with refractory or relapsed metastatic cancer with impaired renal function and with~     normal renal function. It is very possible that patients with renal impairment will show~     differences in renal excretion of parent ASA404 and its metabolites, warranting a study that~     leads to a better pharmacokinetic assesssment in this population.~   "
174671|NCT01278745|"~     All people who have a heart transplant are at risk for developing cardiac allograft~     vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated~     with poor heart transplant function. People who develop antibodies after transplant have a~     higher risk of developing CAV. Infections, high cholesterol, and rejection also increase the~     risk of developing CAV. People who develop CAV usually have to receive another transplant.~   "
174672|NCT01278732|"~     The investigators aim to investigate whether central systolic blood pressure, as measured~     during regular 24 hour ambulatory blood pressure monitoring (ABPM), is a better predictor of~     left ventricular mass than peripheral systolic blood pressure during ABPM.~   "
174673|NCT01278719|"~     Nasal polyp is a significant health problem with a prevalence of 4%. It is increased in~     patients with asthma (7-15%), Cystic fibrosis (39-56%) or aspirin intolerance (36-96%).The~     quality of life (QOL) is worse than in patients suffering from hypertension, migraine, angina~     pectoris and head & neck cancer as per a previous study by Videler WJM et al.QOL is in~     comparison to chronic obstructive pulmonary disease.The reason why it develops in some and~     not in others remains unknown despite the disease being present for centuries.A definite~     relationship exists in patients with 'Sampter triad': Asthma, non steroidal anti-inflammatory~     drug sensitivity and nasal polyps. But not all patients with NSAID sensitivity have nasal~     polyps and vice verse.~      Etiology is largely unknown despite the disease being present for centuries. Although the~     factors like wood stove exposure, smoking, allergic rhinitis, rhino sinusitis have been~     strongly implicated in literature from various studies, most data available is on ethmoidal~     polyps.The present study is an attempt to study the association of important risk factors~     with both antrochoanal(AC) and ethmoidal nasal polyps(EP).One study found that a~     significantly smaller proportion of the population with polyps were smokers compared to the~     unselected population (15% v/s 35%). But this is not confirmed by other studies.~      Seven percent of asthma patients have nasal polyps and in non atopic asthma and late onset~     asthma, polyps are diagnosed more frequently (10-15%).Eosinophil numbers are significantly~     higher in nasal polyp tissue and further increased in patients with co-morbid asthma and~     aspirin sensitivity.~      Nasal colonization in increased amounts was found by Staphylococcus aureus and presence of~     specific Immunoglobulin E directed against S.aureus enterotoxins was found. Rates of~     colonization and IgE presence in nasal polyp tissue were increased in subjects with nasal~     polyp associated with co-morbid asthma and aspirin sensitivity.~      Nasal polyps are frequently found to run in families, suggesting a hereditary or with shared~     environmental factor. In the study by Rugina et al., more than half of 224 nasal polyp~     patients (52%) had a positive family history while the study by Greisener et.al, reported 14%~     of family history strongly suggesting hereditary factors in the pathogenesis of nasal polyps.~      Some studies have found environmental factors like smoking and those using wood stove as a~     primary source of heating with the development of nasal polyps. The studies are contrasting.~      There is presently a need of understanding the differences in the pathogenesis of~     antrochoanal polyp and ethmoidal nasal polyp clearly.There are hardly any concrete research~     performed on them to note the differences in the etiology and their pathogenesis. Hence the~     study is undertaken to extensively study the etiologies responsible for them and to note the~     differences.~   "
174674|NCT01278706|"~     Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal~     time of performing the biopsy is yet to be established.~      In this study, the investigators will compare different temporal timing of the biopsies with~     regards to the menstrual cycle and their affect on the success rates of the treatment.~   "
174675|NCT01278693|"~     The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid~     profile, anemia, and quality of life.~   "
174676|NCT01278680|"~     Employees of Blue Shield of California (BSC) will be recruited to participate to regularly~     use Walkstations. Some participants will be randomly assigned to a hold out control~     condition and the remainder will be assigned to one of two experimental treatments: Personal~     Incentive vs. Charitable Incentive. In the Personal Incentive condition people will be paid~     $3 for every completed Walkstation session, whereas for participants in the Charitable~     Incentive condition $3 will be donated to a specific charity. The incentives will operate for~     approximately 45 days and then for an additional 45 days participants in the two experimental~     conditions will have access to the Walkstations. Participants in the hold out control~     condition will begin using the Walkstations after the initial 90 day period.~   "
174677|NCT01278667|"~     Children with ADHD are in high risk to develope social difficulties. The present study will~     examine the emotional processing in those children. The main purpose is to investigate the~     connection between memory and recognition of facial expressions, how those abilities~     influence social functioning and if Methylphenidate influence the emotional processing.~      The study will include 80 children in ages 9-12 years, devided in 2 groups; children with~     ADHD treated with Methylphenidate, and healthy children without ADHD. The children will do~     computerized tasks that examine recognition and memory of facial expressions. Social function~     will be examined by questionnaires filled by parents and teachers.~   "
174998|NCT01274494|"~     The aim of this multi-centre survey is to assess treatment adherence and quality of life in a~     Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled~     essential hypertension being on antihypertensive treatment for at least 6 months.~   "
174678|NCT01278654|"~     The purpose of the study is to learn more about effective ways to motivate people to increase~     their non-exercise energy expenditure exercise. This is an important research question~     because obesity and weight-related issues are increasingly becoming a problem in America.~     This project will address this research question by testing the effect of two different~     incentive schemes in motivating employees who are predominantly sedentary to use Walkstations~     at work. The Walkstations are treadmills that move at a very slow rate (maximum 2miles /~     hour) and are attached to a work station (i.e. with computer and telephone); they therefore~     are designed to increase energy spent not through heavy exercise, but through small changes~     in posture and movement associated with routines in daily life (called nonexercise activity~     thermogenesis or NEAT).~      Subjects will be employees of Blue Cross Blue Shield of Massachusetts (BCBSMA). Subjects will~     be the control participants from the previous Walkstation study we ran with BCBSMA. All 120~     control participants from this previous study will be told that they can now participate in a~     study that involves the Walkstations (up until now, they have not been given access to the~     Walkstations). These participants from the previous study will be sent an email informing~     them that they are eligible to participate in this new Walkstation pilot. Those who are~     interested in participating will then be invited to sign up for an enrollment session. There~     will be no incentives for participating in the initial enrollment session. For the 2 month~     follow-up session, participants will have a chance to win 1 of 3 prizes (1 * $100, 2 * $50)~     for completing the follow-up.~   "
174679|NCT01278641|"~     A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or~     Chronic Widespread Pain (Wolfe 1990) participate in the study.~      The main objective of the study is to compare the effect of a graded strength training~     program and a low intensive pool exercise program.~   "
174680|NCT01278628|"~     Physical activity is considered important in prevention and treatment of obesity and~     metabolic syndrome. Genotype of genes involved in metabolism is also known to be associated~     with the development of metabolic syndrome. However, scarce evidence exists regarding the~     influence of physical activity intensity and genotype on metabolic syndrome in people with~     obesity. The investigators examine physical activity using an uniaxial accelerometer, as well~     as aerobic fitness using an electric bicycle ergometer, several genotypes of genes related to~     glucose and lipid metabolisms in middle-aged men with obesity and/or abdominal obesity who~     were employees in silicon wafer manufacture and participated in a health checkup.~   "
174681|NCT01278615|"~     This phase II clinical trial is studying how well selumetinib works in treating patients with~     relapsed or refractory diffuse large B-cell lymphoma. Selumetinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
174682|NCT01278602|"~     The aim of study is to prove R-ESHAP regimen followed by autologous stem cell transplantation~     as salvage treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is~     effective.~   "
174683|NCT01278589|"~     The purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L.~     extract in subjects with mild hyperlipidemia.~   "
174684|NCT01278576|"~     The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between~     two different injection sites, namely at the proximal portion of the gastrocnemius(GCM)~     versus at the midbelly of the GCM.~   "
174685|NCT01278563|"~     Epidemiological studies suggest a role for a low glycemic index (GI) diet in the management~     of obesity and associated metabolic risks including diabetes. However, evidence from~     long-term, randomized controlled trials exploring the relationship between low GI diet,~     weight reduction and glycemia, particularly in children and adolescents, is lacking. Modern~     food-processing technology has produced many food products with high GI which may contribute~     to the burgeoning epidemic of obesity worldwide. Since dietary habits are shaped in early~     life, adolescence is a critical period to educate our young people to acquire a healthy~     eating habit to prevent obesity.~      The investigators hypothesized that, in Chinese adolescents, low GI diet results in greater~     reduction in body mass index and body fat percentage, enhanced insulin sensitivity and~     favorable changes of cardiometabolic risk factors compared to conventional diet after 12~     months of intervention.~      This study is a randomized controlled trial of a low GI (<55) versus conventional Chinese~     diet (GI>/=70) in adolescents (12-month intervention followed by a 6-month observational~     period) to study; 1) the changes in body mass index and obesity associated changes in~     cardiometabolic profile; 2) the underlying hormonal factors associated with these changes.~   "
174686|NCT01278550|"~     Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and~     stroke. However, low-dose aspirin increases the risk of ulcer bleeding. Current evidence~     indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events~     and the risk of ulcer bleeding is low (about 1% per year). Since the overall risk of bleeding~     is low, aspirin users who do not have previous ulcer disease do not require prophylaxis with~     anti-ulcer drugs. In contrast, aspirin users with a history of ulcer disease have a 2- to~     4-fold increased risk of ulcer bleeding. The best strategy for reducing the risk of bleeding~     in high-risk aspirin users remains unclear. Current strategies for high-risk patients include~     the use of anti-ulcer drugs, elimination of risk factors (e.g. Helicobacter pylori). Recently~     the investigators have shown that among aspirin users who are infected with H. pylori, the~     eradication of H. pylori is comparable to omeprazole, a proton pump inhibitor (PPI), in~     preventing recurrent ulcer bleeding in 6 months.~      The investigators postulated that among patients with H. pylori infection and a history of~     ulcer bleeding who continue to use low-dose aspirin, the long-term risk of ulcer~     complications after eradication of H. pylori is comparable to that of average-risk aspirin~     users.~   "
174687|NCT01278537|"~     The aims of this study are to investigate whether patient empowerment, including information~     and decision-aids adapted to the risk and the need of the elderly patient, can improve~     outcome in an evidence-based modular pathway in terms of~        -  shortened hospital stay by a reduced postoperative complication rate and~        -  quality of life in elderly patients compared to control patients receiving standard of~          care.~   "
174688|NCT01278524|"~     An anonymous international multicenter - clinical survey, one-day observational study.~   "
174689|NCT01278511|"~     This study is designed to evaluate the safety, level of performance and level of comfort with~     the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.~   "
174690|NCT01278498|"~     Through this study, the investigators are to demonstrate the superiority of Escitalopram over~     placebo for the prevention of poststroke depression in patients with acute stroke~      The primary hypothesis of this study is;~      This study will prove the superiority of Escitalopram on the prevention of poststroke~     depression in patients with acute stroke against placebo~   "
174691|NCT01278485|"~     This is a multicenter, observational, retrospective and cross-sectional study to be conducted~     in a cohort of consecutively selected participants with type 2 diabetes mellitus (T2DM) who~     have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination~     therapy by their cardiologist, nephrologist, or family practice doctor for at least 6 months~     prior to study enrollment.~      The purpose of the study is to assess treatment patterns, goal attainment rates, long-term~     diabetes complication rates, and frequency and severity of hypoglycemic episodes among T2DM~     participants treated in cardiology, nephrology and family practice settings.~   "
174692|NCT01278472|"~     Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone~     disease. Single-port access cholecystectomy (SL) has been recently introduced using only one,~     trans-umbilical placed port. The method has been denominated as ''scarless.'' However, it is~     unknown whether SL significantly improves body and cosmesis images as well as the quality of~     life (QoL), reported directly by the patients. Furthermore SL promises to reduce~     postoperative pain and to be cost-effective due a faster postoperative recovery.~      The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL~     is superior to LC in improving patients', body and cosmesis images as well as QoL and to~     analyse cost-efficiency.~      Based on the sample size calculations, a total of 110 patients will be randomised to either~     LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to~     convalescence, quality of life and complications and will also be compared as secondary~     endpoints.~      This study will provide evidence-based patient-oriented information regarding the SL~     procedure and its further use.~   "
174693|NCT01278459|"~     The purpose of the study is to test the hypothesis that a short course of atorvastatin can~     improve vascular function in women with a history of preeclampsia, compared to placebo.~   "
174694|NCT01278446|"~     The primary objective of this clinical trial is to determine whether a new extensively~     hydrolyzed infant formula is hypoallergenic.~   "
174695|NCT01278433|"~     The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in~     China.~      Objective:~      To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at~     2, 3, and 4 months of age among infants living in the study cities of China.~   "
174696|NCT01278420|"~     The purpose of this study is to compare the visual outcomes with bilateral implantation of~     Tecnis MF and ReSTOR IOLs Six months post cataract surgery.~   "
174697|NCT01278407|"~     The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with~     Lewy bodies (DLB).~   "
174698|NCT01278394|"~     The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in~     the treatment of distal, subungual onychomycosis of the great target toenail.~   "
174699|NCT01278381|"~     Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications.~     No score is currently available to help identify the patient's surgical risk. The purpose of~     this study was to develop and validate a prognostic score to predict major postoperative~     complications after PD.~   "
174700|NCT01278368|"~     No comparative trial investigating the effect of preoperative chemotherapy for locally~     advanced pancreatic cancer on short-term postoperative outcome has been published so far. The~     aim of the present study is to assess the potential impact of preoperative chemotherapy on~     short-term postoperative outcome after pancreatic resection in a case-matched series of~     cancer patients.~   "
174701|NCT01278355|"~     The purpose of this study is twofold: 1) to test the feasibility of integrating a simple~     bilateral ear acupuncture procedure (Auricular Stimulation Procedure - ASP) into the standard~     care delivered in the Aeromedical Evacuation system and 2) to observe and document any~     changes in pain scores and in-flight related symptoms and factors (e.g. sinus block/pain, ear~     block pain, nausea/air sickness) typically monitored during transportation of wounded~     warriors from Ramstein Air Base (RAB) to Andrews Air Force Base (AAFB).~   "
174702|NCT01278342|"~     This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose~     monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone~     antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth~     factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at~     conventional regimen.~   "
174703|NCT01278329|"~     Auditory stimulation during pregnancy has been found to influence foetal behaviour with a~     potential of being carried forward to neonatal period. This study evaluated the effect of~     ante-natal music exposure to primigravida healthy mothers on the behaviour of their term~     appropriate-for-date newborns. This was a single centre, randomized, open-label controlled~     trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or significant~     deafness, with singleton pregnancy, with a gestation of 20 weeks or less were randomized to~     listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard~     ante-natal care (intervention arm) or standard care only (control arm). Peri-natal factors~     with adverse effect on neonatal behaviour were deemed as protocol violations. The infants~     born to mothers exposed to music during pregnancy performed significantly better on 5 of the~     7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation and~     habituation.~      Conclusion:~      Music exposure to mother during pregnancy significantly influences neonatal behaviour.~   "
174704|NCT01278316|"~     This study is being conducted to understand whether training in tasks that require perceiving~     and thinking about things, or cognition, can improve memory in veterans who have been exposed~     to a blast explosion and have TBI and PTSD. A primary goal of the study is to determine~     whether it is feasible for veterans who don't live close to a VA to perform this cognitive~     training at home.~   "
174737|NCT01277887|"~     This is a pilot research study examining two types of behavioral counseling along with the~     nicotine patch for smoking cessation. The study is designed to find out whether one of these~     counseling interventions is more effective for smoking cessation among individuals with sleep~     problems. The study has three parts: 1) an intake session; 2) a 10-week treatment phase, and~     3) a 1-month follow-up.~   "
174705|NCT01278303|"~     Coarctation of the aorta (CoA) is a congenital abnormality producing obstruction to blood~     flow through the aorta. Coarctation can occur in isolation, in association with bicuspid~     aortic valve or with major cardiac malformations. CoA accounts for 5-8% of the 8/1000~     (4-6/10,000) children born with congenital heart disease. Most CoA is newly diagnosed in~     childhood; < 25% recognized beyond 10 yrs.~      CoA is mostly repaired in childhood by surgery or by balloon catheter dilation. Recurrence~     rates range from 5-20%. Recurrence is often not recognized until adolescence. Balloon~     expandable stents have become the predominant therapy in the USA and Europe for CoA treatment~     in this age group. There are no FDA approved stents for this use. Biliary stents are~     currently being used off label. Enrollment into a trial of bare metal Cheatham Platinum (CP)~     Stents, designed for use in CoA, is completed. The Coarctation of the Aorta Stent Trial~     (COAST) aims to confirm safety and efficacy of CP Stent for native and recurrent CoA.~      There are CoA patients with clinical situations that place them at high risk of aortic wall~     injury during bare metal stenting. Extreme narrowing, genetic aortic wall weakness and~     advanced age are examples. Patients may present with aortic wall injury (aneurysm) related to~     prior CoA repair. The occurrence after surgical repair is 3-4% and after balloon dilation~     10-20%. Repair of these aneurysms is surgically challenging. The use of fabric-covered CP~     Stents to prevent or repair aortic wall injury has become the treatment of choice in Europe~     and recently in the US through the FDA Compassionate Use process. There are no alternative~     devices available in the US. COAST II will test safety and efficacy of Covered CP Stents to~     repair or prevent aortic wall injury associated with CoA.~      Funding Source-FDA OOPD~   "
174706|NCT01278290|"~     The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency~     of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard.~      Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment.~      Study population are girls with suspicious clinical features of precocious puberty~   "
174707|NCT01278277|"~     The general area of research in which this project has been designed is that of retinal~     degeneration related to mutations in the ABCR gene, responsible of Stargardt disease/fundus~     flavimaculatus retinal dystrophy (STD/FF). STG/FF is one of the major causes of vision~     impairment in the young age. STG/FF originates typically from the dysfunction and loss of~     cone and rod photoreceptors, developing through a photo-oxidative mechanism. The major~     disease locus is the central retina, i.e. the macula, whose neurons have the highest density~     and underlie critical functions such as visual acuity, color vision and contrast sensitivity.~     There is currently no cure for STG/FF. Recent experimental findings indicate that Saffron,~     derived from the pistils of Crocus Sativus, may have a role as a retinal neuro-protectant~     against oxidative damage. The stigmata of Crocus sativus contain biologically high~     concentrations of chemical compounds including crocin, crocetin, whose multiple C=C bonds~     provide the antioxidant potential. In addition it is well known that this compound is safe~     and free of adverse side effects. The aim of this research is to investigate the influence of~     short-term Saffron supplementation on retinal function in STG/FF patients carrying ABCR~     mutations. The macular cone-mediated electroretinogram (ERG) in response to high-frequency~     flicker (focal flicker ERG) will be employed as the main outcome variable. Secondary outcome~     variable will be the psychophysical cone system recovery after bleaching.~   "
174708|NCT01278264|"~     Comparing morphine consumption and recovery with two different TAP block techniques after~     abdominoplasty.~   "
174709|NCT01278251|"~     This study seeks to test the hypothesis that endobutton repair of the ruptured distal biceps~     successfully restores elbow function.~   "
174710|NCT01278238|"~     The purpose of this study is to determine wether intravenous Phenylephrine, administered as~     start bolus and following continuous infusion (specific dosage per weight), or optimal lower~     limb bandaging is more effective in preventing hypotension during caesarean section under~     spinal anaesthesia in healthy women.~      The hypothesis is that the Phenylephrine model is superior to lower limb compression in~     preventing hypotension.~   "
174711|NCT01278225|"~     The goal of this study is to learn if using a non-invasive therapy called neurofeedback~     training can help teach patients ways to modify their own brain waves to decrease the~     perception of pain and improve quality of life.~   "
174712|NCT01278212|"~     The goal of this study is to explore the safety, effectiveness, quality of life, and cost~     effectiveness of accelerated hypofractionated radiotherapy (AHF-RT) as treatment after~     lumpectomy in patients with early stage breast cancer.~   "
174713|NCT01278199|"~     Severe hemoptysis is a life-threatening condition, with an unpredictable course. The efficacy~     of bronchial artery embolization (BAE) is well established for the treatment of severe~     hemoptysis, with short and long-term bleeding controls obtained in 70 to 100% and 50 to 90%~     of cases, respectively. As complications related to vascular interventional radiology may~     occur in 5 to 10% of cases, the benefit-risk balance might be less clear in acute hemoptysis~     of mild-to-moderate abundance (volume between 100 and 200 ml) and no criteria of severity~     (respiratory failure or hemodynamic instability). There is no available data comparing the~     safety and efficacy of BAE combined with medical measures to those of medical measures alone~     in the treatment of non-severe acute hemoptysis of mild-to-moderate abundance.~   "
174714|NCT01278186|"~     This study in bifurcated coronary lesions compares the new technology of the~     paclitaxel-eluting balloon with the usual technique until now of provisional stenting with~     the paclitaxel-eluting stent in the main branch.~   "
174715|NCT01278173|"~     The purpose of the study is to evaluate the change in visual fields by means of automated~     static perimetry and to evaluate the change in retinal structure by means of spectral domain~     optical coherence tomography (SD-OCT) in adult patients with refractory complex partial~     seizures (CPS) being treated with vigabatrin (Sabril®)~   "
174716|NCT01278160|"~     This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic~     control of biphasic insulin aspart 30 twice daily with two different dosage split regimens~     for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a~     glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).~   "
174748|NCT01277744|"~     The goal of this clinical research study is to learn if heated intra-abdominal cisplatin can~     help to control abdominal tumors in patients having surgery to remove the tumors. The safety~     of this drug will also be studied.~   "
174717|NCT01278147|"~     The purpose of the present project is to develop, implement and evaluate a pilot regional~     patient education program on the management of one of the main side effects of chemotherapy~     in cancer patients, that is fatigue.~      A carer (doctor or nurse) trained in educational techniques will be responsible for the~     patient. The carer will first identify modes of behavior and competences that the patient~     must acquire in order to optimize his/her management of fatigue (educational diagnosis). An~     education program, based on a contract of goals will be proposed after this diagnosis phase.~     The expected results are, in the short-term, a significant reduction in the mean level of~     fatigue in patients receiving chemotherapy who benefited from individual educational~     management. In the longer term, the aim is to evaluate the impact of this program on patient~     quality of life and use of healthcare structures in comparison with conventional management.~   "
174718|NCT01278134|"~     This multicenter, randomized, double-blind, parallel group study will evaluate the safety and~     efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without~     Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B,~     interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100~     mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200~     mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm~     patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop~     all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week~     follow-up.~      As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in~     conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg~     subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a~     24-week follow-up.~   "
174719|NCT01278121|"~     One of today's major health problem in the western world is related to lifestyle. Lifestyle~     diseases include obesity, type 2 diabetes, cardiovascular diseases and different types of~     cancers. For many years, a low-fat diet has been recommended to reduce obesity and lifestyle~     diseases, but replacing fat with carbohydrates has lead to an increase of these diseases.~     Overweight is associated with a chronical low-degree inflammation, and later studies have~     shown that carbohydrates have an effect on the mechanisms of inflammation. Previous studies~     in the investigators group has shown that in healthy, but slightly overweight persons, a~     balanced diet of lower carbohydrate content regulates the gene expression in a manner that~     leads to less inflammation. In this study the investigators will look at morbid obese women~     (BMI>35) to see if the same, balanced diet can improve the inflammatory profile of the women.~   "
174720|NCT01278108|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)~     and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).~      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple~     oral administration will be evaluated, and, if applicable, the maximum tolerated dose~     determined.~   "
174721|NCT01278095|"~     The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of~     GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of~     GLPG0555.~   "
174722|NCT01278082|"~     This study aims to demonstrate the superiority of budesonide compared to placebo as~     maintenance therapy in keeping patients in remission over a one-year period~   "
174723|NCT01278069|"~     Myeloid Sarcoma (or granulocytic Sarcoma or Chloroma) is well defined by the WHO. However,~     there are currently no data about the prevalence, sites of occurence and thr prognostic value~     for patients with AML with this finding. Information about this condition is based on~     retrospective analyses since there have been no studies trying to define the role of myeloid~     sarcoma in AML so far. This observational trial will include adult patients with newly~     diagnosed and relapsed AML in order to perform 18FDG-PET-CT imaging prior to induction~     chemotherapy. Furthermore, a second 18FDG-PET-CT will be performed after induction~     chemotherapy to define the responsiveness of these tumors to chemotherapy. The primary~     endpoint of this study is the prevalence of 18FDG-PET-CT positive extramedullary AML~     manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed AML.~   "
174724|NCT01278056|"~     This is a Phase I/II open-label uncontrolled, prospective study to assess the clinical and~     biological effects of Deferasirox (ICL 670, Exjade®) in patients with NASH and increased iron~     storage / distribution of iron on liver function and liver histology.~      NASH is defined clinically and histologically by elevated liver enzymes, signs of hepatic~     steatosis on ultrasound and magnetic resonance imaging, impaired liver function as expressed~     by functional breath tests, and significantly altered liver histology.~      Patients will be treated in a phase I and phase II part for either 12 or 48 weeks.~      Both study parts have different endpoints: in phase I the side effect profile will be~     evaluated while in phase II the therapeutic response will be tested. Accordingly, measures~     will be different.~      Approximately 10 patients in phase I and 50 patients in phase II will be enrolled according~     to sample size calculations.~      The design is an adaptive Two-stage design, allowing to minimize the number of patients~     included into the trial as well as to introduce corrections for the second stage.~   "
174735|NCT01277913|"~     The aim of the study is to assess the effect of 12 month supplementation with two different~     doses of vitamin D ( 500 vs 1000) on bone mineral density, serum 25 hydroxyvitamin D levels~     and hand grip strength in preadolescents with diabetes mellitus type 1.~      100 children in the of age 8 -11 with diabetes mellitus type 1 lasting for more than 3~     months, without history of diabetic ketoacidosis during previous month, without other chronic~     disease which may affect calcium-phosphorus metabolism will be randomized in a double blind~     controlled trial to supplement them with either 500 IU or 1000 IU vitamin D. Every 3 months,~     in spring summer,autumn and winter serum level of calcium,25-hydroxyvitamin D level and HbA1c~     will be measured. At the entry and at the end of the study patients will have total body and~     lumbar spine bone mineral density assessment. Every six months hand grip strength will be~     measured. Additionally at the beginning and after 12 mo of supplementation and at the~     beginning serum levels of TNF-alfa, osteoprotegerin and IL-6 will be assessed.~   "
174762|NCT01277562|"~     The investigators hypothesis is that secondary causes of bone loss are prevalent in patients~     with breast and prostate cancer, and those patients with secondary causes of bone loss are at~     higher risk for treatment related bone loss. The goals of this pilot study are to estimate~     the prevalence of secondary causes of osteoporosis in a cohort of patients with nonmetastatic~     breast and prostate cancer with osteopenia and osteoporosis.~   "
174725|NCT01278043|"~     Subjects in this study have recently had or are scheduled for a percutaneous coronary~     intervention (PCI) as part of their normal, routine medical care. This procedure should~     restore the blood flow in the vessels of the heart.~      One complication that can occur after a PCI procedure is blood clotting and narrowing of the~     artery in the area that was treated. This can result in a decrease in the blood flow to the~     heart. To avoid this complication, patients are given antiplatelet or blood-thinning drugs~     such as aspirin and clopidogrel as part of their routine care after this procedure.~      For this research study, the investigators would like to take blood samples from subjects at~     3 different time points while they are taking these antiplatelet drugs. The investigators~     will study the subjects' blood and medical history to help us further our understanding of~     how these drugs respond in individuals and in certain patient populations. Everyone responds~     a little differently to medications due to many reasons including our genetic make-up. Genes~     are passed down from our parents and determine our physical appearance such as the color of~     our hair and eyes. Differences in our genes may also help explain why some drugs work in some~     people, but not in others. By studying subjects' blood, medical history, genetic make-up and~     by recording how the subjects' blood responds over the course of their treatment, the~     investigators hope to learn more about how our bodies respond when taking these drugs.~     Additionally, the investigators hope to find better ways to predict who will respond more~     effectively to these drugs and better ways to monitor how these drugs are working in~     patients' bodies over time after PCI procedures.~   "
174726|NCT01278030|"~     The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT)~     responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead~     placement compared to traditional LV lead placement.~   "
174727|NCT01278017|"~     The purpose of the investigators study is to evaluate if short-course of ceftriaxone therapy~     could shorten the clinical courses of severe nontyphoidal Salmonella enterocolitis in~     children and the excretion of Salmonella in feces.~   "
174728|NCT01278004|"~     This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side~     effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive substance)~     to test whether any response is a true effect of the drug, and not a 'placebo effect'.~   "
174729|NCT01277991|"~     In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate~     occasions using one of two different strength tablets each time. The amount of CP-690,550~     available in the blood following administration of each tablet will be measured and compared.~     The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed~     into the blood following administration of the same dose of each different strength tablet .~   "
174730|NCT01277978|"~     The purpose of this study is to evaluate the immediate effects of carbetocin and oxytocin on~     maternal hemodynamic parameters (heart rate and blood pressure) in a non-invasive setup~     (TaskeForce®-Monitor) during primary Caesarean section.~   "
174731|NCT01277965|"~     Primary aim:~      To show that in subjects with type 1 diabetes with a subcutaneous continuous insulin~     infusion, adjustment of the recommended basal insulin flow rate in the event of physical~     activity allows the subjects to practice sports without any increase in incidence of~     hypoglycaemia during physical activity or the ensuing hours.~      (NB: hypoglycaemia is defined as blood glucose less than 3 mmol/l or 0,54 g/l in accordance~     with the EMEA definition).~      The proposed algorithms consist of a temporary reduction in basal flow of 50 percent or 80~     percent (temporary basal flow TBR50 or TBR80) depending on the intensity of physical activity~     (50 percent of VO2max or 75 percent of VO2max). Switching off the pump will also be studied~     as an option to adjust insulin dosage in the event of unprogrammed physical activity~     (temporary reduction of basal flow by 100 percent).~      Secondary aims:~        -  Characterisation of hypoglycaemia during and after physical activity based on CGMS data:~          symptomatic or non-symptomatic nature of hypoglycaemia, time to onset of hypoglycaemia~          in relation to the start of physical activity, degree and severity of hypoglycaemia.~        -  Evaluation of overall variations in blood glucose in the event of physical activity~          using CGMS data (area under the curve).~        -  Evaluation of glucose restoration methods used in the event of hypoglycaemia.~        -  Analysis of subgroups of patients with and without hypoglycaemia.~   "
174732|NCT01277952|"~     The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe~     disability due to Traumatic Brain Injury.~   "
174733|NCT01277939|"~     This study will evaluate the comparative effectiveness of Therapeutic Education System (TES),~     a computer-based, psychosocial treatment program, relative to standard care when offered to~     individuals with substance use disorders in prison settings. The study will assess the~     comparative effectiveness of these interventions primarily by examining changes in: (1)~     substance use (e.g., weeks of abstinence), (2) HIV risk behavior (evaluated as both~     sex-related and drug-related HIV risk behavior) and (3) reincarceration rates. The study will~     also examine the extent to which these interventions improve psychosocial functioning (e.g.,~     employment, health, and psychological status) and quality of life, and promote relevant~     skills acquisition (e.g., improve communication skills, reduce criminal thinking). The~     investigators predict significantly better outcomes for E vs. C due to TES' research-based~     content and use of proven informational technologies.~   "
174734|NCT01277926|"~     The purpose of this study is to characterize the current patterns of care for patients with~     hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy~     in Brazil. To investigate patient-related, disease-related and physician-related~     characteristics that correlate with the use of either endocrine treatment or chemotherapy in~     such patients. And to evaluate patients' understanding of the treatment options and their~     participation in the choice.~   "
174736|NCT01277900|"~     Type 2 diabetes mellitus (T2DM) resolution in morbidly obese patients following bariatric~     surgery suggests the efficacy of metabolic surgery in non-morbidly obese patients (body mass~     index [BMI]<35 kg/m2). Many researches have shown available evidence about the efficacy and~     safety of metabolic surgery for resolution of T2DM in the non-morbidly obese. One of the most~     effective metabolic surgeries is laparoscopic Roux-en-Y gastric bypass (LRYGB). The~     investigators intend to run a 3 year prospective multicenter study to evaluate the remission~     efficacy of laparoscopic Roux-en-Y gastric bypass in Type 2 Diabetes mellitus with low BMI~     (BMI:25-35) in Asia area.~   "
174738|NCT01277874|"~     This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP)~     respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or~     non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if~     Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without~     oscillations. This will be measured by need for change to ventilator support, improvement in~     pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of~     NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP,~     time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of~     study to end of respiratory treatment.~   "
174739|NCT01277861|"~     The investigators plan to test the hypothesis that pretreatment with fentanyl prior to~     induction of anesthesia would result in reduce the incidence of movements and airway~     responses to desflurane in patients breathing spontaneously through a laryngeal mask airway~     (LMA). The primary aim of this study is to assess the effect of fentanyl pretreatment on the~     incidence of movement during induction of anesthesia. Secondary aim of the study is to~     evaluate the effects of titration of fentanyl according to the respiratory rate on the~     incidence of intraoperative respiratory events such as coughing, breath holding and~     laryngospasm.~   "
174740|NCT01277848|"~     The PLAC1 gene is a recently described X-linked gene that maps to a region of the X~     chromosome thought to be important for normal fetal and placental development. Elevated~     levels of PLAC1 mRNA were detected in preeclampsia and appeared to be directly related to~     disease severity. PLAC1 may serve as a useful marker of placental dysfunction or threatened~     pregnancy.~      The objective of this study is to measure the prevalence of circulating anti-PLAC1 antibodies~     in pregnant maternal serum and correlate it with pregnancy outcome. It is likely that women~     with these antibodies are at higher risk for adverse pregnancy outcomes. Approximately 5% (50~     of 1000) will be expected to have anti-PLAC1 antibodies based on previously reported data.~     The prevalence of these antibodies and their clinical impact on pregnancy outcomes will be~     determined.~      1000 healthy, multiparous and primigravid women will be screened for anti-PLAC1 antibodies at~     their routine prenatal clinic visits. Subjects will be enrolled at their first clinic visit~     at USF Health, South Tampa Center, Department of Obstetrics. Blood (1.0 ml) will be obtained~     as part of the routine blood draw at the time of enrollment. Blood will only be collected~     when drawn as part of routine laboratory testing as determined by the primary care provider.~      Additional blood samples (1.0 ml) will be collected throughout pregnancy at the same time~     blood is obtained for routine or otherwise clinically indicated laboratory testing. A maximum~     of 5 samples will be collected through the pregnancy.~      Maternal demographic data will be collected and patients will be followed longitudinally to~     the completion of pregnancy to ascertain their clinical status during pregnancy, onset of~     premature labor, premature rupture of membranes, delivery date, and gestational age at~     delivery.~   "
174741|NCT01277835|"~     The purpose of this study is to determine whether intravenous lidocaine infusion during a~     video-assisted chest surgery is effective in reducing the pain involved after the surgery.~     The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic~     surgery (VATS) reduces morphine consumption and postoperative pain.~   "
174742|NCT01277822|"~     This study will determine whether using losartan and amlodipine together will be non-inferior~     in lowering blood pressure than amlodipine alone.~   "
174743|NCT01277809|"~     The purpose of this study is to assess the effectiveness of a regular walking program (which~     inevitably involves human interaction) compared to a usual care condition and to a human~     interaction condition (without the extra walking program) in individuals residing in~     Long-Term Care (LTC). Outcomes of interest include: balance, strength, mobility, endurance,~     walking distance; rate and severity of falls; activities of daily living; mood and behaviour.~      It is hypothesized that participants taking part in the walking program will demonstrate~     maximal benefits compared to the no treatment control group (usual care) and the participants~     who will only receive social interaction. It is expected that benefits of the walking program~     will include decreased fall rates, and improved balance, endurance, strength, mood,~     behaviour, activities of daily living and quality of life indices. Given research findings~     that the addition of pleasant activities improves resident mood (Teri et al, 1997; 2003), it~     is expected that participants in the social interaction only group will demonstrate~     improvements in mood and other indices of quality of life.~   "
174744|NCT01277796|"~     Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are~     expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable.~     Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous~     Leishmaniasis in South America. However, current heat-delivery modalities are either too~     costly or lack governmental approval required to be made widely available to endemic areas.~     The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous~     Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the~     investigators will enroll 25 patients who have either failed or are not candidates for~     pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy~     non-statistically inferior to estimates for current South American Pentavalent Antimonial~     cure rates (76%) while demonstrating basic safety and tolerability.~   "
174745|NCT01277783|"~     The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective,~     non-randomized, multi-national clinical investigation.~      The purpose of this clinical investigation is to evaluate the safety and performance of the~     investigational atrial transseptal endocardial LV lead delivery system and the implant~     procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a~     superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in~     the Left Ventricle.~   "
174746|NCT01277770|"~     The purpose of this study is to improve outcome for kidney transplant recipients. There has~     not been commensurate improvement in medium and long-term outcomes. Ongoing clinical research~     is necessary to improve transplant outcomes.~   "
174747|NCT01277757|"~     This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with~     breast cancer cancer that has spread to other places in the body and usually cannot be cured~     or controlled with treatment. Akt inhibitor MK2206 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
174749|NCT01277731|"~     Dexamethasone is a potent synthetic member of the corticosteroid. It is given to cancer~     patients undergoing chemotherapy to counteract emetic side effect and essential drug for the~     chemotherapy-treated patients. Hiccup is common adverse effect of corticosteroid especially~     on dexamethasone varying from 3% to 60% of given patients. Discontinuance of dexamethasone~     relieves most hiccupping cases, but vomiting/nausea rates increase. It is not clear whether~     hiccup side effect is limited to the dexamethasone only or other corticosteroid group.~      Methylprednisolone, synthetic corticosteroid as similar as dexamethasone, could be considered~     as antiemetic agent for the patients with receiving chemotherapy. The investigators perform~     this pilot study under hypothesis that replacing dexamethasone with methylprednisolone could~     maintain antiemetic role and prevent hiccup.~   "
174750|NCT01277718|"~     This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover~     study of cobimetinib in healthy participants to evaluate the effect of the proton-pump~     inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy~     participants when administered in the fed or fasted states.~   "
174751|NCT01277705|"~     This study will assess the immunogenicity and reactogenicity of the candidate GSK~     Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis-~     inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in~     Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine~     administered separately, and with Revaxis®~   "
174752|NCT01277692|"~     This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled,~     double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of~     GSK2336805 in healthy subjects and the safety, tolerability, PK, and antiviral profile of~     GSK2336805 in subjects chronically infected with HCV: i. Single doses in healthy subjects and~     the effect of food on GSK2336805 PK (Part 1). ii. Repeat doses in healthy subjects (Part 2)~     iii. Single doses in chronically infected HCV positive subjects (Part 3).~   "
174753|NCT01277679|"~     The aim of this study is to establish a model for the evaluation of drug targets using~     postural measures to induce changes in lung water concentration as assessed by MRI. A~     reduction in the magnitude and rate of water transudation with postural changes in patients~     with congestive heart failure (CHF) could provide a model for the evaluation of various~     classes of molecules for target validation and for dose selection.~   "
174754|NCT01277666|"~     This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and~     safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to~     placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease.~     Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease~     in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response).~     Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary~     endpoint. Safety will be assessed by recording of adverse events, clinical laboratory~     parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will~     evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in~     Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and~     Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.~   "
174755|NCT01277653|"~     There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role~     of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program~     for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if~     the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early~     stages of HCC than the 6 month interval of AFP that is commonly used~   "
174756|NCT01277640|"~     The purpose of this study is to determine the safety of male genitalia when exposed to~     dapivirine gel following seven once daily applications.~   "
174757|NCT01277627|"~     Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in~     HIV/HCV-coinfected individuals.~   "
174758|NCT01277614|"~     The investigators previously established that there was a high burden of disease among all~     categories of staff at the University of the West Indies, St. Augustine and in many ways,~     this group is typical of the working class of the Caribbean population. Many had poor~     lifestyle behaviors, 23.8% had Metabolic Syndrome (MS) with many having one or more MS~     components. Since most time is spent at work, the workplace is understandably the most~     logical location to address issues pertaining to health, disease prevention and wellness and~     on-site programs have yielded many health and other benefits to employees and employers~     alike. Onwards of the 1980s, numerous studies have been done on work-site intervention~     programs and these have shown that if a company is able to identify employees at risk for~     developing health problems and then intervene, health risks and the resulting medical~     problems are reduced. Such a program, if tailored to meet the needs of participants, may~     yield similar benefits among the staff of the University of the West Indies.~   "
174759|NCT01277601|"~     The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil~     fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus~     standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults~     with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen~     (HBsAg).~      The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks~     + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment,~     participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and~     those meeting TDF retreatment and flare management criteria will be eligible to receive TDF~     monotherapy during a retreatment phase, up to Week 120.~   "
174760|NCT01277588|"~     During labor, fetal scalp sampling is performed if the CTG registration is abnormal. The test~     is performed with the woman in the supine position and is generally described as a difficult~     and cumbersome procedure.~   "
174761|NCT01277575|"~     The investigators assess if repetitive, transcranial alternating current stimulation (rtACS)~     can improve the speaking quality of the aphasic patient as well as other communication skills~     as naming, repeating and understanding spoken words, reading and writing. Further, it will be~     assessed if memory and attentiveness deficiencies after 10 days of therapy with brain~     stimulation are stabilized and remain stable after a training-free period of 60 days.~   "
174763|NCT01277549|"~     The purpose of this protocol is to characterize the performance of CaridianBCT's Spectra~     Optia Apheresis System, when used to collect mononuclear cells (MNCs) and cluster of~     differentiation 34 (CD34) positive cells from healthy nonmobilized blood donors and healthy~     G-CSF (granulocyte colony stimulating factor) mobilized blood donors, respectively.~   "
174764|NCT01277536|"~     Until now, no risk assessment model informing about the need of thromboprophylaxis in~     patients admitted for an acute medical event has been validated.~      The goal of this project is to indirectly validate a model developed in Geneva by a non~     -interventional study involving the collection of patient characteristics during the~     hospitalization and a 3-month follow-up. These data will allow for the determination of the~     patient's risk, according to the Geneva model, and its validity, according the actual~     thrombo-embolic events, corrected for the thromboprophylaxis received.~      The project is multicentric in Switzerland (5-10 centers) and should involve about 1000~     patients.~      First amendment (may 2011) : we have obtained the IRB approval for collecting data from~     patients who die during their hospital stay and for whom informed consent is not be possible~     to obtain.~   "
174765|NCT01277523|"~     The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation~     solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks,~     compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to~     17 years old) with severe persistent asthma.~      The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and~     possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary~     function endpoint after 12 weeks of treatment.~      Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints,~     and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy~     on top of usual care in this patient population.~   "
174766|NCT01277510|"~     The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the~     current treatment of secondary hyperparathyroidism in children currently receiving dialysis~     compared to a treatment regimen that does not include cinacalcet.~   "
174767|NCT01277497|"~     Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast~     growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart~     disease. As kidney function declines, less phosphorus is removed by the kidneys and as a~     result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more~     FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In~     addition to effects on FGF-23, increased phosphorus levels can lead to calcification~     (hardening) of the blood vessels in the CKD population.~      Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus~     absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD,~     studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering~     FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification~     of blood vessels in the CKD population.~      This study is being done to determine if using phosphate binders, either sevelamer carbonate~     or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease~     FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood~     vessels and heart disease.~   "
174768|NCT01277484|"~     Brief Scientific Rationale:~      Decitabine has been shown to be effective for treatment of MDS and associated with very~     limited extramedullary toxicity at the lower doses. Furthermore, the hypomethylating effects~     of decitabine require an extended period of therapy and are likely to be more beneficial in~     the setting of a minimal residual disease after transplantation. The drug might exert a~     cytoreductive effect on the MDS clone, but ex vivo expansion strategy using decitabine and~     HDAC inhibitor provides a potential to expand the number of hematopoietic stem cells. There~     are lots of evidence which showed the the drug have immunostimulatory effects and can be used~     to enhance graft-versus leukemia effects. And also, some investigator suggested that~     decitabine could induce FOXP3 expression, promoting the conversion of naïve T cells to Tregs~     which are known to suppress GVHD while maintaining GVL effect in allo-SCT setting. As such,~     decitabine is an ideal agent to be investigated in the post-transplant setting.~      The investigators hypothesized that post-transplant maintenance therapy with decitabine may~     reduce relapse rate, which may maximize the beneficial effects from reduced TRM of~     ATG-containing FB4 or FB2 conditioning regimen in higher-risk MDS or AML evolving from MDS~     patients.~   "
174769|NCT01277471|"~     Aims and priorities of the project The purpose of this study is to~        1. test the effect of frequency of meals (six vs. two meals daily with the same daily~          caloric restriction of -500 kcal/day) on insulin sensitivity, insulin secretion, and~          hepatic fat content.~        2. characterize some of the mechanisms of action of different frequencies of meals (amount~          of visceral fat, hepatic fat content, serum concentrations of adipokines, gut hormones,~          oxidation stress markers).~        3. test the ability of the participants to maintain hypocaloric diet on both regimens when~          educated and left to prepare their meals alone in comparison with those for whom all~          meals during the study will be provided.~      It will be a randomized, crossover study, where 50 individuals with type 2 diabetes will~     change in a random order two regimens: six, and two meals a day. Each testing period will~     take three months.~      Glucose and lipid metabolism and its regulation will be thoroughly tested at start, and after~     each 3-months-period (meal test, hyperinsulinemic isoglycemic clamp, indirect calorimetry,~     MRI scan of the liver, DXA scan, serum concentration determination of selected adipokines,~     gut hormones, and oxidation stress markers).~      Hypothesis The investigators hypothesize that low plasma insulin levels (as achieved by~     periods of fasting) will reduce insulin resistance and hepatic lipid content. In contrast,~     frequent meals (and consequent higher plasma levels of insulin) will predispose to~     non-alcoholic fatty liver disease and insulin resistance. The investigators further~     hypothesize that the participants will increase their caloric intake with increased meal~     frequency (in spite of thorough education) when left to prepare their meals in comparison~     with those for whom all meals will be provided.~   "
174783|NCT01277289|"~     The aim of this study is the assessment of the efficacy of Ery-Dex (dexamethasone~     intra-erythrocyte) versus placebo in maintaining patients with steroid-dependent Crohn's~     disease in clinical remission throughout 12 months without oral steroids.~   "
174770|NCT01277458|"~     Are there differences between the way that non-White men who have sex with men living in~     London with HIV describe their own ethnicity and the way in which their ethnic group is~     recorded in NHS clinics? We aim to describe the way in which clinics in London currently~     record a patient's ethnic group. Without accurate data for an individual's ethnic group we~     are unable to draw meaningful conclusions about their experiences of HIV care. It may be the~     case that patients from particular ethnic groups require specific ways of monitoring and~     treating their HIV but without knowing if these people are in a particular group any services~     directed to them may be wasted or underused.~   "
174771|NCT01277445|"~     Prebiotics are carbohydrate polymers believed to improve health by stimulating beneficial~     gastrointestinal microbial populations. Prebiotic health claims are currently not permitted~     in Canada due to a lack of validating scientific data. Currently, Health Canada considers~     'prebiotic' to imply a health benefit that must be substantiated. Our goal is to conduct a~     human clinical trial to define the impacts of fructans on the colonic microbiome as well as~     the physiological, psychological and immunological effects on the host.~   "
174772|NCT01277432|"~     The investigators aim to:~        1. Estimate the prevalence of depression in a consecutive cohort of Chinese patients~          diagnosed with Type 2 Diabetes (T2D) living in areas of China with different~          socioeconomical affluence~        2. Examine patients' awareness of the frequent coexistence of these 2 conditions~        3. Analyze the associations between depression and T2D, in particularly the role of~          metabolic control, socioeconomical status and cognitive-psychological-behavioral factors~        4. To document the predisposing, precipitating and perpetuating factors for depression and~          their interrelationships in Chinese type 2 diabetic patients~   "
174773|NCT01277419|"~     The German Spondyloarthritis Inception cohort (GESPIC) was started as a prospective,~     longitudinal, multicentre, nationwide study in Germany on patients with early SpA including~     ankylosing spondylitis and non-radiographic axial SpA. The objectives of GESPIC are to learn~     about the course of AS and other SpA during the very early stage of the disease, to~     appropriately assess the outcome including radiographic progression of patients after several~     years of follow-up, to identify outcome predictors, to assess quality of life, function, and~     costs (direct and indirect costs).~   "
174774|NCT01277406|"~     The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of 4SC-201~     (Resminostat) in combination with FOLFIRI and whether 4SC-201 (Resminostat) is effective and~     safe in combination FOLFIRI versus FOLFIRI alone in the treatment of advanced colorectal~     carcinoma.~   "
174775|NCT01277393|"~     This study is to find out care of critically ill patients enteral nutrition guidelines for~     the implementation of the effectiveness of the intervention.~   "
174776|NCT01277380|"~     The first outbreak of a new H1N1 influenza pandemic originated in the North America in April~     2009. As of July 1, 2009, a total of 77,201 cases were accumulated in 103 countries around~     the world and the mortality rate of was about 0.43%. Alignment and analysis on gene sequences~     of the new H1N1 influenza virus found that it contains extremely homologous gene composition~     with that of the swine influenza viruses (swine flu) identified in Europe and North America~     in last century. Thus the virus strain was later renamed as a novel influenza H1N1. In~     general, the symptoms caused by the new influenza H1N1 infection was very similar to those~     resulted from seasonal influenza viral infection. Thus, it is difficult to distinguish the~     various influenza strains responsible for the infections only by clinical appearance. To~     compare the accuracy, specificity and sensitivity and speed in identifying the new influenza~     H1N1 in suspected cases, the investigators extracted RNA from influenza A-positive reactive~     specimens identified by a Influenza Rapid Test, for a Real-time PCR method to further detect~     the presence of swine H1 gene. In addition, the titer of H1N1 virus, the color development on~     the test stripe and clinical symptoms in patients were significantly associated. Finally,~     Real-time PCR products were subjected to sequence determination to explore potential new~     influenza pathogenicity, transmissibility and drug usage.~   "
174777|NCT01277367|"~     The aim of the study is to prospectively compare the effectiveness of diverse incentives on~     physical activity behaviour, in a cohort of newly-enrolled, adult members of the Vitality~     health promotion programme based in South Africa.~   "
174778|NCT01277354|"~     The purpose of this study is to examine the effects of experiencing a previous pregnancy loss~     or complication on current physiological and emotional aspects of a current pregnancy.~   "
174779|NCT01277341|"~     This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.~   "
174780|NCT01277328|"~     This observational, prospective, open-label, multi-center study will evaluate the~     effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in~     patients with rheumatoid arthritis. Data will be collected for 11 months.~   "
174781|NCT01277315|"~     Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by a~     selective degeneration of the motor nerve cells in the cortex and myelon. As a result of~     motor neurodegeneration, a progredient paralysis of the extremities and of the speaking,~     swallowing, and breathing musculature develops. ALS leads to death by respiratory~     insufficiency in a mean course of 3-5 years. So far, Riluzole is the only approved~     neuroprotective medication which effects a slight lifespan prolongation of 1.5 - 2.5 months.~     Riluzole inhibits the presynaptic glutamate release and lowers the level of glutamate~     liberated by activated microglia.~      The researchers propose an investigational therapy of ALS with subcutaneous administration of~     100 mg of Anakinra. The neuronal inflammation is a crucial pathogenetic factor of the motor~     neuron degeneration. Inflammatory processes are detectable in sporadic ALS, in the~     autosomal-dominant form of ALS and in transgenic mouse model. The rationale of this clinical~     trial is based on the anti-inflammatory effect of Anakinra. One of the key mediators of~     inflammatory response is Interleukin-1. Anakinra is a recombinant produced Interleukin-1~     receptor antagonist. This gives Anakinra anti-inflammatory attributes that presumably reduce~     motor neuron degeneration and disease progression.~   "
174782|NCT01277302|"~     This was a Phase IV multicenter, randomized, open-label study, with masking of the vision~     examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with~     macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein~     Occlusion (CRVO).~   "
179475|NCT01215773|"~     The main objectives of the multiple dose study are to investigate the safety, tolerability~     pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple~     oral administration of BI 671800~   "
174784|NCT01277276|"~     Currently there is no methodology that can assign a risk of development of chemo brain and~     thus, studies to understand how and why only some patients develop chemo brain along with~     studies of potential treatments face major hurdles. This study will define~     hemodynamic/optical parameters in normal individuals and cancer patients undergoing~     chemotherapy potentially identifying optical parameters that are associated with the~     development of chemo brain, leading to new insights into the origin of the chemo brain~     condition, and importantly potentially identifying parameters that may predict who will~     develop chemo brain in order to directing investigations of therapies.~   "
174785|NCT01277263|"~     Women with Breast Cancer who do not respond to chemotherapy may undergo months of treatment~     with little or no change in tumor size or overall outcome.~      The Researchers have demonstrated a previously undescribed metabolic flare response~     observed very early in neoadjuvant treatment in breast cancer patients. The research can~     determine that this flare is predictive of overall therapy response and is due to both an~     inflammatory reaction and cell death induced by cytotoxic therapy.~   "
174786|NCT01277250|"~     This project, Web-based Smoking Cessation Intervention: transition from inpatient to~     outpatient, addresses smoking among hospitalized patients, whose rates are higher than among~     the general population. Hospitalization offers a unique opportunity to intervene, as it~     requires temporary abstinence and patients are focused on health concerns. Hypotheses: A~     tailored web-based and e-message smoking cessation program for current smokers that, upon~     hospital discharge, transitions the patient to continue a quit attempt when home will be~     effective. Further, the investigators hypothesize that this approach will be cost-effective.~     Specific Aims: 1. To test the effectiveness of a web-based smoking cessation intervention. 2.~     To determine the cost-effectiveness of this approach. Research Design - Methods: A randomized~     two-arm follow-up design will be used to test the effectiveness of an evidence- and~     theoretically-based smoking cessation program designed for post-hospitalization. Patients~     randomized to this arm will be contacted by hospital staff, trained as 'transition coaches,'~     to engage in Decide2Quit, an interactive web-based program that offers personalized and~     tailored messages, e-group support, and text messages promoting tobacco abstinence. All~     hospitalized patients will receive standardized smoking cessation materials. As well,~     physicians can order nicotine replacement therapy via the hospital's electronic order system.~     The investigators primary outcome is biologically confirmed and self-reported tobacco~     abstinence at 6 months follow-up; the investigators will also assess self-reported quit rates~     at 3 and 12 months and variables hypothesized to predict quit success. We will measure health~     care utilization and quality of life to allow testing the cost-effectiveness of this program~     conducted from the perspective of a hospital, health care payers, patients and society.~     Significance of results: At study completion the investigators will know whether imbedding~     smoking cessation into usual hospital care, with minimal hospital-staff burden, and an~     interactive web-based tailored intervention program is an effective way to reduce smoking~     rates among hospitalized patients, and if it is cost-effective. This program will be an off~     the shelf approach that could be disseminated easily.~   "
174787|NCT01277237|"~     There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces~     the amount of fat stored in the liver and improves liver function. The purpose of this study~     is to see whether this observation is correct.~   "
174788|NCT01277224|"~     The purpose of this study is to evaluate the effectiveness of a recreational physical~     activity intervention (RPAI) for reducing the prevalence of overweight/obesity and other~     cardiovascular risk factors~   "
174789|NCT01277211|"~     This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of~     pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be~     assessed and compared with that of Yasmin.~   "
174790|NCT01277198|"~     Authors want to investigate the usefulness of flexible cystoscopy in performing laparoscopic~     pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's~     experience.~   "
174791|NCT01277185|"~     The purpose of this study is to identify calcium metabolism characteristics in Mexican~     American adolescents. The investigators predict that calcium requirements to maximize bone~     health in this population will be lower than for white youth but higher than their current~     intakes.~   "
174792|NCT01277172|"~     This is a prospective international, multi-center, randomized, double-blind controlled study~     designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of~     PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated~     patients with diffuse B cells Non Hodgkin lymphoma.~   "
174793|NCT01277159|"~     Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve~     block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa~     nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg~     2008;106:1916-20), but unfortunately the patients still often experience moderate to severe~     pain after the block wears off. The investigators wish to study two additives that may~     prolong the period of analgesia provided by the nerve block. The additives will be studied in~     the context of a standardized postoperative multimodal analgesic pathway.~      Primary outcome:~      Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a~     popliteal fossa nerve block?~   "
174794|NCT01277146|"~     This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously~     treated solid tumors for which there is no remaining standard curative therapy and no therapy~     with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers.~     Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and~     efficacy. No formal interim analyses will be performed.~      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon~     enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing~     schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there~     is no evidence of disease progression or if the tumor is smaller, then subjects may continue~     to receive IV infusions of OMP-59R5 every week until disease progression.~      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose~     escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled~     in a cohort will not be treated on the same day. The dose may be administered at any time~     during the day. Three subjects will be treated at each dose level if no dose-limiting~     toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on~     OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be~     expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be~     dosed at that level and 3 additional subjects will be added to the preceding dose cohort~     unless 6 subjects have already been treated at that dose level. Subjects will be assessed for~     DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled~     subjects, if appropriate, will occur after all subjects in a cohort have completed their Day~     28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to~     continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14~     subjects will be enrolled at the highest dose level that result in <2 of the 6 subjects~     experiencing a DLT.~   "
174795|NCT01277133|"~     This single arm, prospective, observational study will assess the correlation between the~     time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with~     progression-free survival in patients with previously untreated metastatic breast cancer.~     Patients will be followed for up to 12 months after progressive disease occurs.~   "
174796|NCT01277120|"~     This single arm, prospective, observational study will assess the correlation between the~     time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with~     progression-free survival in patients with previously untreated metastatic colorectal cancer.~     Patients will be followed for up to 12 months after progressive disease occurs.~   "
174798|NCT01277094|"~     This multi-center, double-blind, randomized, placebo-controlled study will evaluate the~     change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with~     non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral~     doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.~   "
174799|NCT01277081|"~     The aim of this study is to subjectively assess symptoms in subjects suffering from the~     common cold following a single dose of paracetamol hot drink compared to paracetamol tablet~   "
174800|NCT01277068|"~     Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent.~     Cardiovascular diseases are the first cause of morbidity and mortality. An excess of TRL~     particles is one of the characteristics, represents a major cardiovascular risk factor. The~     overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is~     recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL~     has been shown. In front of this important overmortality, the bariatric surgery quickly~     developed. Three main procedures are performed: 2 based exclusively on the gastric~     restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a~     malabsorption (the gastric bypass).~   "
174801|NCT01277055|"~     Coronary artery disease (CAD) has a great significance concerning prevalence and mortality in~     the western world. It is usually diagnosed by catheterization and coronary arteries are~     visually assessed by the examiner. Thus having a great spectrum of interobserver differences,~     especially when it comes to intermediate lesions. The gold standard to assess the~     haemodynamic significance is the measurement of the myocardial fractional flow reserve (FFR).~     The FAME-study (Tonino, De Bruyne et al. 2009) was able o show that additional FFR-~     measurements in patients with intermediate lesions could significantly reduce stent~     implementation and consequently mortality. However this method is not used in daily routine~     and is available only in a fraction of catheter labs worldwide. Taking this into account~     decision finding especially in intermediate lesions remains difficult.~      One major step to simplify the invasive approach concerning intermediate lesions would be to~     establish a non-invasive procedures which localizes the coronary vessel to intervene ahead~     catheterization.~      Do to steady technical development cardiac MRI has become a powerful tool which is able to~     determine myocardial vitality, perfusion and function. In particular the new generation of 3~     Tesla multi transmit MR with its higher field strength and better spatial resolution seems to~     be able to show first pass myocardial perfusion more precise. With this new technology~     prefixed to cardiac catheterization clinical relevant information can be made accessible and~     thus reduce the number of unnecessary implemented stents.~   "
174802|NCT01277042|"~     This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human~     papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects~     will receive the HPV vaccine and the other group will receive an active control (GSK~     Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with~     those from the HPV group included in the NCT00779766 study (aged 18-25 years).~   "
174803|NCT01277029|"~     To identify the differences in psychopathology, personality traits among different female~     LUTS subtypes.~   "
174804|NCT01277016|"~     In this multi-center phase III trial, untreated patients diagnosed with AL who are not~     candidates for stem cell transplant with melphalan 200 mg/m2 are the target population. Stage~     I and II patients will be eligible. Stage III patients will be enrolled in an ancillary phase~     II study. Eligible patients will be stratified as cardiac stage I or stage II and then~     randomized to receive MDex or BMDex.~      Primary objective is to compare hematologic(clonal) response i.e. the rate of complete~     response (CR) + partial response (PR) defined according to the criteria of the International~     Society for Amyloidosis consensus.~   "
174805|NCT01277003|"~     Carpal tunnel syndrome (CTS) is the most common compressive focal mononeuropathy seen in~     clinical practice. Patients commonly experience a constellation of symptom complex brought on~     by compression of the median nerve as it traverse through the carpal tunnel. When compression~     of the nerve occurs, ischemia and mechanical disruption of nerve function may result.~     Pathological analysis shows a constellation of nerve injuries. Until now, no satisfactory~     conservative treatment method. Local steroid injections or oral steroids may result in~     initial relief, but relapses are frequent and have much side effects, which preclude their~     routine use for CTS. Full time wrist splints are claimed effective, but compromise hand~     function and daily activities. There are reasonable studies showing relief of pain with~     acupuncture on diverse pain conditions. However the therapeutic efficacy of acupuncture in~     CTS was less convincing in the past. Until recent decade, some case reports and few~     prospective studies reported the therapeutic effect of acupuncture in CTS. Other study also~     reported that low-level laser and microamperes transcutaneous electrical nerve stimulation~     (TENS) are effective in improvement of clinical outcome of patients with CTS. Another report~     suggested that TENS should be considered for the treatment of painful diabetic peripheral~     neuropathy. Therefore, the investigators perform this study to evaluate the effect of Aculife~     Magnetic Wave Therapist (a battery operated device with a probe electrode which contains~     magnetic elements that transform the oscillating current into an electromagnetic wave to~     stimulate the acupuncture points, simulate the effect of electroacupuncture ) on CTS and~     compared with that of Transcutaneous Electrical Nerve Stimulation(TENS). After at least 4~     weeks treatment ( at least 16 treatment sessions) the therapeutic effects will be evaluated~     by comparison of symptom severity score, electrophysiological study, sonographic morphology~     study or magnetic resonance imaging study, before and after treatment, and between the~     different groups.~   "
174806|NCT01276990|"~     To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers~     following oral administration of repeated doses for 10 days within 8 dosing regimens.~   "
174807|NCT01276977|"~     The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs.~     eletriptan 40 mg tablet in the acute treatment of migraine.~      To develop and evaluate a set of importance weights for a predefined set of treatment~     attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg~     tablet.~      To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at~     early time points.~      To analyze the patterns of self-reported tolerability of migraine sufferers using~     zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.~   "
174808|NCT01276964|"~     Multicenter, observational, cross-over study intended to apply an easy and simple system for~     the quantitative determination of menstrual losses in women with apparently normal menses.The~     system adopted for the determination of menstrual losses, called QUEM (QUantitative~     Evaluation of Menses), is based on the collection of tampons and pads in standard bags which~     are readily vacuum sealed with a simple device for the whole of woman's period. The~     evaluation will be performed for the whole of one period and the analysis will be performed~     in comparison to the classical reference method, the Alkaline - Hematin Method, which is~     still considered the golden standard.~   "
174809|NCT01276951|"~     In Colombia, ischemic heart disease and stroke are one of the most important causes of death~     in 45 years old people. Care of cases of disease represents high costs for the health system~     in particular and society in general, due to the loss of productive years life and costs for~     the care of the aftermath. Hypertension (HT) is one of the preventable risk factors for major~     cerebrovascular disorders. The pathophysiology of Essential hypertension is complex and~     depends of interaction of genetic and environmental factors. Among the determining elements~     are the increase in the activity of the sympathetic nervous system, the vasoconstricting and~     overproduction of hormones associated with sodium retention, disruption in renin secretion~     with increased production of aldosterone and angiotensin II, the deregulation of the kinins~     system, the increase in peripheral vascular resistance and activity of Growth factors in~     atherogenesis and vascular endothelial dysfunction, increased cardiac output, diabetes~     mellitus, obesity, and lower production of vasodilators such as brain natriuretic peptide~     (BNP), the prostacyclins and nitric oxide (NO), among others.~      Cocoa is a food rich in flavonoids, which stimulate the enzyme activity of endothelial nitric~     oxide synthase (e-NOS), responsible of the production of NO in vascular smooth muscle. The~     flavonoids modulate the synthesis of inflammatory substances that are derived from~     endothelial cells and the immune system.~      In a recent study found that with a few grams of cocoa achieves a significant reduction in~     blood pressure, so the investigators propose a controlled clinical trial to assess the effect~     of different doses of cocoa on blood pressure and endothelial inflammation in men with~     essential hypertension, stage I-II without target organ damage, in addition to pharmacologic~     monotherapy defined for the management of their disease. The investigators hope to determine~     an optimal dose of cocoa, with long-term effects, by their high content of flavonoids,~     improves cardiovascular and endothelial parameters with the advantage that it is an~     economical and easy introduction into the patient's habits.~   "
174810|NCT01276938|"~     Aim of the study is to evaluate toxicity in breast cancer patients treated with two different~     doses of Intra Operative Radiotherapy~   "
174811|NCT01276925|"~     Patients undergoing total hip arthroplasty may experience severe postoperative pain. This is~     normally treated with opioids, which can cause side effects such as nausea, vomiting,~     obstipation and sedation. The hypothesis is that patients receiving peripheral nerve blockade~     of three nerves leading pain stimuli from the hip will experience less pain, will consume~     less opioid and therefore have less side effects, and will be mobilized more quickly than~     patients not receiving the peripheral nerve blockade.~   "
174812|NCT01276912|"~     -  Pre-diabetes is a significant risk factor for the development of type 2 diabetes, as~          well as macrovascular and microvascular complication.~        -  Previous studies show that 50% or more loss in islet B-cell function even in~          Pre-diabetes phase. The early insulin therapy in pre-diabetes may be a strategy in~          preventing metabolic disorders and cardiovascular disease.~        -  The objective of this study is to find if an initial insulin glargine intervention in~          pre-diabetes (IGT and /or IFG) could be a strategy in preventing type 2 Diabetes.~        -  Pre-diabetes subjects will receive a insulin glargine therapy with a dosage adjusted to~          get FBG ≤ 5.3mmol / L as the goal. Insulin glargine treatment will be maintained for~          three months thereafter to find if it can prevent diabetes.~   "
174813|NCT01276899|"~     This is a multicenter translational study to understand therapeutic resistance in patients~     undergoing standard chemotherapy for triple negative breast cancer.~      In the neoadjuvant setting, biopsy tissue samples from primary tumor will be collected and~     banked before the start of chemotherapy and after the completion of the treatment~     (post-chemotherapy and at the time of surgery). In the metastatic setting, tissue samples~     from metastatic lesions will be collected and banked before the start of chemotherapy and at~     the time of tumor progression. Additionally, blood samples will be drawn before treatment~     initiation (baseline) and at different time points during treatment. All samples will be~     stored in the Biological Resource Repository.~   "
174814|NCT01276886|"~     Patients were recruited over a four year period from 1996 to 1999. Those admitted in the~     years 1996 and 1997 were retrospectively accrued from the clinical records, while patients~     treated between 1998 and 1999 patients were entered on the database prospectively on~     admission.~      Inclusion criteria All consecutive patients with left sided acute diverticulitis diagnosed~     clinically by the presence of abdominal pain, associated with leukocytosis (>11x109) and/or~     fever >38°C, confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema)~     either alone or in combination and/or by operative findings, entered the study. The CT~     criteria for the diagnosis included a localized thickening (≥4 mm) of the colonic wall and~     signs of inflammation of the pericolic fat, with abscess and/or extraluminal air and/or~     extraluminal contrast. The criteria for ultrasound included at least two of the following~     signs: bowel wall thickening (>4 mm), diverticular inflammation, pericolic fat edema,~     intramural or pericolic inflammatory mass, intramural fistula. The diagnostic criteria for~     water soluble contrast enema included segmental luminal narrowing and a tethered mucosa with~     or without a mass effect or extravasation of contrast and/or the presence of extraluminal~     air.~      Exclusion criteria Patients with inflammatory bowel disease, irritable bowel syndrome,~     colorectal cancer or diseases precluding adequate follow up, were excluded from the study.~      Treatment Patients were treated conservatively (antibiotics, I.V. nutrition, CT/US guided~     abscess drainage) or surgically according to the local policy of each center.~      Follow up Follow up was carried out according to local policy. The following data were~     collected: persistence or recurrence of chronic symptoms attributable to complicated~     diverticular disease, new episodes of AD, new hospital admissions for AD, type of treatment~     and outcome.~      Recurrence was defined as a new episode of AD requiring hospitalization that occurred at~     least 2 months after complete resolution of the index episode which resulted in inclusion in~     the study. If surgery was performed, the timing, type of procedure, Hinchey stage and~     complications were recorded.~      Data collection A standardized flow sheet was used to collect data on medical history,~     diagnostic work up, type of treatment and follow up to create a dedicated database. Gender,~     age, date of hospital admission and discharge, diagnosis on admission and discharge,~     co-morbidities (diabetes mellitus, cardiovascular disease, atherosclerosis, liver or renal~     failure), symptoms experienced before admission and their duration, history of~     diverticulosis, previous episodes of AD, laboratory tests, and treatment performed were~     recorded. Where surgery was performed, the date and type of procedure, the operative findings~     including Hinchey's classification (16) and details of the operation (incision, extension of~     resection, type of anastomosis, covering stoma, drains), pathology report, and postoperative~     complications occurring within 30 days, were all recorded.~      End points The primary endpoint was to assess the rate of recurrence of AD requiring~     hospitalization during the follow-up period. Additional endpoints were to assess the risks of~     emergency surgery, stoma and disease-related mortality during the follow up.~   "
174815|NCT01276873|"~     To compare clinical effects identified in infants undergoing intratracheal aspiration with~     open and closed systems and verify the presence and intensity of pain in newborns during~     intratracheal suction, according to the system applied.Clinical, randomized, controlled, and~     crossover study, performed at two neonatal intensive care units after approval by the ethics~     committee. The sample consisted of infants from zero to seven days of age, 26 weeks of~     gestational age, and the exclusion criteria were use of mechanical ventilation with~     high-frequency oscillatory, in use of inhaled nitric oxide, in the acute phase of circulatory~     failure, central nervous system disorders, without reactivity to stimulus, severe asphyxia,~     Apgar score less than three in the fifth minute, as well as, presence of chromosomal~     abnormalities and congenital malformations. After obtaining the informed consent from the~     responsible, children were randomly allocated into the experimental (CS) and control (OS)~     groups. The dependent variables of this study respiratory rate (RR), peripheral oxygen~     saturation (SatpO2), heart rate (HR), blood pressure (BP) and pain, as well as, of the~     complementary variables, were collected through observation, the Premature Infant Pain~     Profile (PIPP) scale application and medical records consultation. During the data collection~     the period of variables observation were: T1 (immediately before suctioning), T2 (during~     suctioning), T3 (immediately after) and T4 (10 minutes after). To the statistical analysis~     were applied Fisher exact test, McNemar, Binomial, Student t test, Wilcoxon and Mann Whitney,~     settling at 0.05 level of significance.~   "
174816|NCT01276860|"~     Obstructive sleep apnea results in decreased attentiveness and response times in patients.~     The objective of this study is to quantify these consequences in pediatric OSA patients using~     an already established tool for examining the results of sleep deprivation and fragmentation:~     psychomotor vigilance testing. PVT has been used in children, but has not been studied in~     pediatric OSA patients. This study aims to employ PVT along the normal course of diagnosis~     and treatment of pediatric OSA patients in our clinical practice at Arkansas Children's~     Hospital. The investigators hypothesize that pediatric OSA patients will exhibit decreased~     PVT scoring when compared to children without OSA, and that PVT can be used to diagnose and~     monitor treatment outcomes in these patients.~   "
174817|NCT01276847|"~     This is a two-part study. The purpose of the pilot study (Part 1) is to optimize the~     acquisition, handling and shipping procedure for skin biopsies obtained from participants~     with plaque psoriasis. No treatment will be administered. Part 2 will include 2 cohorts. In~     Cohort 1, the effects of 16 weeks of treatment with either ustekinumab or etanercept on~     biomarkers in lesional skin in participants with moderate to severe psoriasis will be~     evaluated. In Cohort 2, biomarkers of lesional skin from participants with moderate to severe~     psoriasis who are not treated with biologic therapy will be evaluated over 16 weeks. The~     primary hypothesis is that treatment with ustekinumab reduces messenger RNA (mRNA) expression~     of genes in the interleukin 12 (IL-12) pathway that are modulated by interferon gamma~     (IFN-γ).~   "
174818|NCT01276834|"~     To compare in a prospective randomised way the effect of two different immunosuppressive~     regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery~     calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after~     transplantation.~   "
174819|NCT01276821|"~     To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity~     scores among children aged 6 weeks to 24 months with bronchiolitis.~   "
174820|NCT01276808|"~     Rationale: Magnetic navigation in complex lesions/vessels may result in reduced contrast and~     irradiation for patients undergoing percutaneous coronary intervention. The investigators aim~     to compare the use of the 2 techniques.~      Objective: To compare the use of contrast and irradiation used in magnetically navigated PCI~     (MPCI) with conventional guidewire PCI (CPCI) in patients with complex anatomy (as defined by~     a clinical prediction rule).~      Study design: Prospective randomised controlled, single-blind trial Study population: Healthy~     human volunteers aged 18 to 80 years of age Intervention (if applicable): One group has the~     placement of the angioplasty wire with magnetic navigation and the other has the angioplasty~     wire placed by conventional technique. All other interventions will be performed as per~     routine practice.~      Main study parameters/endpoints:~      Primary endpoint The primary endpoint is the amount of contrast used.~      Secondary endpoints~        1. Contrast needed to cross a lesion~        2. procedural time~        3. radiation exposure~        4. Clinical complications at 1 and 12 months~        5. procedural success~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      The index procedure is performed as per normal routine and includes history and examination.~     A blood test will be taken once vascular access has been obtained. After the procedure a~     questionnaire will be filled in. The patient will have a blood test 2 to 3 days after the~     procedure, telephone follow-up will occur at 1 and 6 months and a further outpatient visit~     with ECG will be planned for a year after the index procedure. No additional significant~     physical or psychological discomfort is expected with participation in the study.~   "
174821|NCT01276795|"~     A prospective, randomized and controlled study is proposed to establish whether an enteral~     nutrition support regimen based on pressurized whey protein and glucose improves the~     postoperative utilization of amino acid substrates compared to a drink based on glucose~     alone. The kinetics of protein metabolism (protein breakdown, protein synthesis and amino~     acid oxidation) will be investigated using stable isotope methodology before and after~     surgery in patients undergoing colon resection. Stable isotope infusions will be conducted~     one week before surgery and on the second postoperative day for two hours in the fasted state~     and for four hours while sipping the enteral nutrition support regimen. Patients will consume~     one of two enteral nutrition support regimens consisting of a drink containing either~     pressurized whey protein and glucose or glucose alone. It is hypothesized that an enteral~     nutrition support regimen based on pressurized whey protein and glucose promotes positive~     protein balance through increased protein synthesis or reduced protein breakdown compared to~     glucose alone.~   "
174822|NCT01276782|"~     The last two decades have witnessed an explosion of new research documenting the deleterious~     impact that thyroid disease has on pregnancy and the postpartum period, in relation to~     miscarriage preterm delivery intelligence quotient of the unborn child and health of the~     mother postpartum. Both subclinical hypothyroidism and thyroid antibody positivity in~     euthyroid women have been associated with miscarriage and preterm delivery. Approximately 5%~     of all pregnant women have a thyroid disorder. both spontaneous miscarriage and preterm~     delivery.~      Systemic lupus erythematosus (SLE), an autoimmune disorder of unknown etiology, has also been~     documented to negatively impact pregnancy. Women with Systemic lupus erythematosus (SLE)have~     increased rates of miscarriage and preterm delivery. Women with Systemic lupus erythematosus~     (SLE) also have increased rates of hypothyroidism and autoimmune thyroid disease (AITD,~     defined as the presence of thyroid antibodies with or without thyroid dysfunction). Preterm~     delivery (PTD), defined as birth prior to 37 weeks gestation, is the leading cause of~     neonatal mortality and morbidity in the United States. Although risk factors for preterm~     delivery exist, the majority of women have no known risk factors. Recently, both~     hypothyroidism and autoimmune thyroid disease have also been linked to preterm delivery.~     Given the increased prevalence of negative outcomes documented in pregnant women with thyroid~     disease, and the increased rates of hypothyroidism and Autoimmune thyroid disease in women~     with Systemic lupus erythematosus (SLE), the investigators determined that Autoimmune thyroid~     disease was associated with both preterm delivery and miscarriage. This has led to this~     application to begin a pilot randomized clinical trial of thyroxine in autoimmune thyroid~     disease in systemic lupus erythematosus pregnancy.~   "
174823|NCT01276769|"~     This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel~     plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized~     that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel~     plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and~     sensitive to carboplatin.~   "
174824|NCT01276756|"~     Chronic hepatitis C has become an endemic disease in Egypt with a rising prevalence (genotype~     4), worldwide it also poses a significant health burden. To date standard of care treatment~     (pegylated interferon and ribavirin) give modest results with a sustained virological~     response (SVR) of about 50%. Several pharmaceutical and herbal agents have been used with an~     aim to improve current results. Recent reports have suggested an increased SVR with the~     addition of Nitazoxanide to standard of care. The results are preliminary and need to be~     confirmed. This is a randomized trial to assess the efficacy of nitazoxanide added to~     standard of care compared to standard of care alone.~   "
174825|NCT01276743|"~     The protein tyrosine phosphatase non-receptor type 22 (PTPN22) gene encodes a~     lymphoid-specific phosphatase (LYP) which is an important downregulatory factor of T cell~     activation. A PTPN22 polymorphism, C1858T, was found associated with T1DM in different~     Caucasian populations.~      In this observational case-control study, we aimed at confirming the role of PTPN22, C1858T~     polymorphism in T1DM predisposition in a Greek population.~   "
174826|NCT01276730|"~     The study objective:~        -  To evaluate the response and survival rates after treating stage III cervical cancer~          with retinoic acid and interferon-α combined with radiotherapy in the study group.~        -  To evaluate the response and survival rates after treating stage III cervical cancer~          patients with concomitant cisplatin and radiotherapy in the control group.~        -  To evaluate the safety and tolerability of the combination of retinoic acid,~          interferon-α and radiation therapy compared with concomitant chemo-radiation therapy.~        -  To determine if there is an immune response to Human Papillomavirus (HPV) by estimating~          serum IgG1 and IgG2 antibodies against E7 proteins of HPV types 16 and 18 before and~          after treatment.~      The study hypothesis:~        -  The response rates and survival rates of retinoic acid and interferon-α combination with~          radiation will be better than chemo-radiation to treat stage III cervical cancer.~        -  Treatment with the retinoic acid, interferon-α and radiation combination therapy will be~          less toxic and better tolerated than chemo-radiation therapy.~   "
174827|NCT01276717|"~     This will be a phase I study of carfilzomib in combination with vorinostat in patients with~     relapsed/refractory B-cell lymphomas. Combination therapy with proteosome inhibitor PR-171~     and HDAC inhibitors is highly synergistic in primary DLBCL cells, and both classes of drugs~     can also synergize powerfully to induce cell death in bortezomib-resistant cells. The purpose~     of this study is to see if vorinostat can combine with carfilzomib and to safely find the~     recommended phase II dose.~   "
174828|NCT01276704|"~     The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at~     increased risk for development of breast cancer.~   "
174829|NCT01276691|"~     The investigators hypothesize that~        1. an acute treatment of low-dose aspirin will lead to a) decreased resting platelet~          activation, platelet aggregation, and clotting potential, b) increased fibrinolytic~          potential following fire fighting, c) no significant effect on endothelial function or~          arterial stiffness versus the placebo condition.~        2. chronic treatment with low-dose aspirin will lead to a) decreased resting and fire~          fighting induced platelet activation, platelet aggregation, clotting potential, b)~          increased fibrinolytic potential, and c) increased endothelial function and decreased~          arterial stiffness in response to live fire fighting versus the placebo condition.~        3. short-term fire fighting activity will result in: a) a reduction in arterial function~          (reduced endothelial function, increased augmentation index and an attenuated arterial~          stiffness response); b) a disruption in hemostasis that is characterized by an increase~          in platelet number and function, an increased coagulatory potential and altered~          fibrinolytic potential; and c) an elevation in procoagulatory cytokines, systemic~          inflammation, monokine chemoattractant protein, and matrix metalloproteinases.~   "
174830|NCT01276678|"~     About 13 million people in the United States have coronary artery disease (CAD). It is the~     leading cause of death in both men and women.~      Coronary artery disease (CAD) occurs when the blood vessels that supply blood to the heart~     muscle (the coronary arteries) become hardened and narrowed. The arteries harden and narrow~     due to buildup of fatty and calcified material called plaque on their inner walls. The~     buildup of plaque is also called atherosclerosis. This is a process which starts early in~     life, but can be influenced by multiple factors.~      Several factors increase the risk of developing atherosclerosis. They include high blood~     pressure, smoking, diabetes, high cholesterol and being related to someone who had a heart~     attack or a stroke. The more risk factors you have, the greater the chance that you have~     severe atherosclerosis. Some of the risk factors cannot be modified, like age and family~     history of early heart disease. The influenceable factors include high blood pressure, high~     blood cholesterol, high blood sugar, cigarette smoking, overweight or obesity, and lack of~     physical activity.~      Nevertheless, there are patients without any above mentioned risk factors who develop~     atherosclerosis. In addition to that, there are also patients with several risk factors who~     do not develop severe coronary artery disease.~      According to research studies high blood levels of some substances in the blood (biochemical~     markers) as well as some genes in the DNA of our cells may be associated with an increased~     risk of developing CAD and faster progression of the disease.~      The purpose of this study is to find a correlation between certain blood markers and growth~     of the plaques, regardless of the presence of the classic risk factors for atherosclerosis.~     If we prove our hypothesis we will be one step closer to predicting the extent of~     atherosclerosis by performing certain blood tests.~   "
174831|NCT01276665|"~     Perioperative fluid management in abdominal surgery is a subject of controversy and current~     standard fluid therapy is not evidence based. Compensating decreasing blood pressure by~     volume substitution is common praxis. Alternatively the fall in blood pressure due to~     vasodilatation can be corrected by applying vasoactive agents. A review of the data on the~     effect of high volume perioperative fluid therapy suggests that overhydration may have~     deleterious effects on cardiopulmonary function as well as on recovery of gastrointestinal~     motility, tissue oxygenation and wound healing. Restrictive fluid administration in~     fast-track surgery led to no differences in all-over recovery after colonic surgery. Based on~     our current knowledge, a low volume regimen combined with a noradrenaline perfusor may be of~     benefit during open radical cystectomy. It seems of interest and safe to use a noradrenaline~     perfusor combined with a low volume regimen during open radical cystectomy. The low volume~     regimen, as described in this study protocol, is well established at our institution, which~     has a large experience in cystectomy.~      The aim of this study is to compare intraoperative blood loss, quality of the surgical field,~     metabolic response, pain relief, fatigue score, gastrointestinal function, cardiovascular,~     pulmonary, infectious and surgical complications as well as cognitive function in two groups~     of patients undergoing radical cystectomy.~      The investigators expect a lower complication rate in the restrictive fluid regimen group and~     better surgical conditions. This could significantly affect short- and long-term outcome of~     patient undergoing major cancer surgery, have an impact on survival and financial~     consequences.~   "
174832|NCT01276652|"~     This study examines the feasibility of assessing sleep and circadian rhythmicity in~     critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the~     feasibility of reducing subject exposure to environmental light and noise and of delivering~     routine care according to classical day/night routines.~   "
174833|NCT01276639|"~     The main objective of this study is to compare the effects of CP-690,550 with the effects of~     placebo in patients being treated for moderate to severe chronic plaque psoriasis. This~     one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.~   "
174834|NCT01276626|"~     The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum~     (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome~     (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood,~     memory, general well-being and bowel symptoms will be assessed before, at the end of the~     treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic~     profile and inflammatory markers will be also measured.~   "
174835|NCT01276613|"~     The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer~     cells, to measure the amount of it that may enter the cells, and for biomarker testing.~     Biomarkers may be related to participant's reaction to the study drug.~   "
174836|NCT01276600|"~     Describe the dose-proportionality and intra-individual variability of tenofovir diphosphate~     (TFV-DP) and emtricitabine triphosphate (FTC-TP) at steady-state in healthy human~     participants taking Truvada® (FTC 200mg/TDF 300 mg) under direct observation.~   "
174837|NCT01276587|"~     This pilot study aims to answer the question whether monthly oral vitamin D3 supplementation,~     100,000 IU, will be safe and effective in raising serum 25-hydroxyvitamin D (form of vitamin~     D measured in the blood) to levels considered sufficient (30 ng/mL) but well below the~     threshold for toxicity (150 ng/mL) in children with sickle cell disease. Information from~     this study will be crucial before we perform a larger clinical trial to determine the effects~     of vitamin D in reducing respiratory complications in patients with sickle cell disease.~   "
174838|NCT01276574|"~     The purpose of this study is to determine, whether there is clinical benefit of using~     fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed~     tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial~     ovarian cancer (EOC)~        -  Objectives~             -  the impact of preoperative PET/CT compared to CT on EOC stage definition~             -  to compare the value of preoperative PET/CT, CT and laparoscopy in intra-abdominal~               tumour assessment. Laparotomy findings evaluated by surgeon and histopathologic~               results serve as the reference standard.~             -  to compare serum markers HE4(human epididymis protein 4) and CA125 (cancer antigen~               125) with FDG-PET/CT and CT in treatment response evaluation during neoadjuvant~               chemotherapy and primary treatment of EOC~             -  to compare FDG PET/CT based treatment response evaluation with RECIST and GCIG~               criteria~        -  Methods~             -  All the patients will undergo FDG-PET/CT prior surgery, after possible neoadjuvant~               chemotherapy (NACT) and 4 weeks after completion of primary platinum-based~               chemotherapy.~             -  CA125 and HE4 levels are measured pre-operatively and with every chemotherapy~               cycle.~   "
174839|NCT01276561|"~     This is a prospective trial of single incision versus standard 4-port laparoscopic~     splenectomy.~      The hypothesis is that there may be a difference in wound infection rates, operative time,~     doses of analgesics post-operatively, and patient/parent perception of scars. However, the~     technical difficulty is considerable and the primary outcome is operative time which will be~     expressed in minutes.~   "
174840|NCT01276548|"~     The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of~     Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment~     in Subjects With Ovarian Cancer.~   "
174841|NCT01276535|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in the treatment of acne blemishes.~   "
174842|NCT01276522|"~     Schnitzler syndrome is a disabling inflammatory disease, characterized by chronic urticaria,~     fever, arthralgia, bone pain and gammopathy, which can so far only be effectively treated~     with anakinra, an interleukin-1 receptor antagonist. However, this drug is not registered for~     use in Schnitzler syndrome, and it needs to be injected daily, which is uncomfortable and~     unpractical. Therefore other treatments targeting IL-1 are needed. Canakinumab is a~     long-acting monoclonal antibody against IL-1β that has been registered for bimonthly use in~     the rare autoinflammatory disease Cryopyrin-associated periodic syndrome (CAPS). We~     hypothesize that it will be effective in Schnitzler syndrome too in view of clinical~     similarities to CAPS and the targeting of IL-1B, which is also blocked by anakinra (which~     blocks both IL-1B and IL-1A).~      This is a 6-month open-label, single treatment arm study of canakinumab 150 or 300 mg (in~     case of insufficient response to 150 mg) subcutaneous injection once per month in patients~     with active Schnitzler syndrome, in which efficacy and safety will be assessed.~   "
174843|NCT01276509|"~     Adults with Crohn's disease that is clinically active despite conventional treatment will be~     eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental~     drug) or placebo (inactive drug). Disease activity will be measured every two weeks.~   "
174844|NCT01276496|"~     This phase I trial studies the side effects and the best dose of cilengitide when given~     together with paclitaxel weekly in treating patients with solid tumors that have spread~     nearby or to other areas of the body and cannot be removed by surgery. Cilengitide may stop~     the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as paclitaxel, work in different ways to the stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving cilengitide together with~     paclitaxel may kill more tumor cells.~   "
174845|NCT01276483|"~     The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI~     and CT separately and combined for the evaluation of treatment response and progression-free~     survival in patients with GIST.~   "
174846|NCT01276470|"~     Background:~        -  Like other complex diseases, autoimmune diseases are the result of numerous causes,~          including genetic and environmental factors. Some researchers believe that people who~          are susceptible to autoimmune disorders develop them when the body reacts to~          environmental or other factors by creating white blood cells that attack the body s own~          tissues, which then progresses to autoimmune diseases. These immune-triggered disorders~          can overlap with one another to some extent, but most autoimmune diseases have certain~          distinct triggers.~        -  The autoimmune disorder myositis weakens the muscles and may cause other health~          problems. Environmental exposures associated with myositis include ultraviolet~          radiation, stressful life events and muscle overexertion, collagen implants, infections~          such as retroviruses and streptococci bacteria, and certain drugs and chemicals. Some~          individuals with myositis also produce proteins in the blood called autoantibodies that~          react with certain parts of the person s own cells, called synthetases, which are~          involved in making new proteins. A syndrome called the anti-synthetase syndrome, which~          includes myositis and lung disease, is associated with having the anti-synthetase~          autoantibodies. Researchers are interested in studying differences in environmental~          exposures in individuals with myositis. This study is being conducted to determine if~          persons with the anti-synthetase syndrome have had different environmental exposures~          before disease onset compared with other patients with myositis who do not have this~          syndrome and also compared with healthy volunteers.~      Objectives:~      - To determine whether selected infectious and noninfectious environmental exposures are more~     common in individuals who have myositis with the anti-synthetase syndrome, compared with~     healthy volunteers.~      Eligibility:~      - Individuals who have been diagnosed with myositis (with or without anti-synthetase~     autoantibodies), and healthy volunteers without autoimmune disorders.~      Design:~        -  Participants will be screened with a full medical history and physical examination, and~          will provide blood, urine and house dust samples.~        -  Participants will complete questionnaires about their medical history and the types of~          exposures they have had at work, at home, and elsewhere. Participants who have myositis~          will also be asked about certain infections, heavy exercise or physical exertion, sun~          exposure, tobacco and alcohol use, and stressful events prior to being diagnosed with~          the disease. Healthy volunteers will be asked about the same exposures before the date~          of diagnosis of disease of the myositis subject to which they have been matched.~        -  Participants will receive a kit that contains instructions and a filter to be put onto~          their vacuum cleaner to collect house dust in the bedroom. This dust will be kept for~          possible future analyses of infectious or toxic agents based on the other results from~          the study.~        -  Individuals with myositis will have other tests as clinically indicated, including lung~          function tests and imaging studies.~   "
174847|NCT01276457|"~     The purpose of this study was to allow the continuation of everolimus treatment in patients~     who have completed the core study (NCT00170885) and to collect long-term safety,~     tolerability, and efficacy data in a group of patients treated with the upper everolimus~     target levels plus very low dose cyclosporin in comparison with the standard everolimus~     target levels plus low dose cyclosporin in patients with renal transplantation.~   "
174861|NCT01276275|"~     The purpose of the study is to describe patient characteristics and drug usage among patients~     that are prescribed ticagrelor for the first time and to compare them with patients who are~     prescribed clopidogrel and prasugrel for the first time.~      A further purpose is to ascertain and estimate the crude incidence rate of bleeding,~     arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout among~     new users in the three cohorts of ticagrelor, clopidogrel and prasugrel.~   "
174848|NCT01276444|"~     Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of~     current cardiosurgical practice.~      Several approaches were introduced into the clinical practice to alleviate systemic~     inflammatory response induced by cardiopulmonary bypass and organ-specific injury including~     meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of~     anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic~     hypothermia. An in-depth monitoring of haemodynamics, oxygen transport, and vascular~     permeability is of a great clinical value to control the efficacy of these approaches.~      Therefore, the aim of this study was to compare two algorithms of goal-directed therapy aimed~     to achieve a postoperative haemodynamic optimization in combined valve repair surgery.~   "
174849|NCT01276431|"~     An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and~     safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe~     osteoarthritis pain of the hip and/or knee.~   "
174850|NCT01276418|"~     This study is intended to collect data regarding treatment with a new flexible fiber used to~     transmit laser emitted from a Carbon dioxide (CO2) laser to the transoral region. This study~     will include a single treatment that is performed transorally (through the mouth) for oral or~     laryngeal indications in the field of Ear, Nose and Throate (ENT).~   "
174851|NCT01276405|"~     This observational study will evaluate Xeloda (capecitabine) monotherapy on the effect of~     disease-free survival in patients with colon cancer stage III (Duke C) after surgical~     resection. Data will be collected for 3 years.~   "
174852|NCT01276392|"~     Actual clinical practice predominantly makes use of heparin (systemically) or citrate~     regionally as anticoagulation in the extracorporeal circulation for renal replacement~     therapy. We aim to find out if different anticoagulation strategies may lead to different~     levels of platelet activation and whole blood coagulation. Regarding coagulation activation,~     it remains uncertain if there is an advantage for one of these methods. However, it is of~     major interest to minimize the risk of any additional clotting activation via extracorporeal~     circulation in these usually critically ill patients.~   "
174853|NCT01276379|"~     Advanced colorectal cancer (ACRC) is a heterogeneous disease and classification of patients~     is nowadays inefficient. Roughly twenty per cent of patients present with favorable figures~     (less than 4 liver nodules and less than 5 cm) and are suitable for local treatments (surgery~     or local-ablative therapies). Additionally, 10-15% of patients have poor performance status~     (PS >2) or are severe disabled due to geriatric syndromes or/and co-morbid diseases that~     preclude any treatment strategies than best supportive care alone. The rest of patients (fit~     patients not suitable for radical treatments) constitute the population of patients treated~     with palliative therapies. Despite of it not all these patients have the same prognosis.~     Patients with PS 0,1 and levels of LDH <ULN (Intermediate-risk patients) have better PFS and~     OS irrespective of therapy in all randomized clinical trials (de Gramont et al, JCO 2000;~     Douillard et al, Lancet 2000; Koopman et al, 2007).~      CRYSTAL trial shows a benefit in PFS (1.5 months) in RASWT of FOLFIRI plus cetuximab compared~     with FOLFIRI alone. Nowadays the selection of patients for cetuximab treatment is based on~     mutational status of KRAS, which allow to select those patients who will not respond to~     therapy. Other surrogate markers of activity should be also evaluated. Our hypothesis is that~     the suggested biomarkers will allow the selection of the patients who will benefit the most~     from the biweekly cetuximab treatment.~   "
174854|NCT01276366|"~     Last thirty years, many research was performed concerning pain in the newborn. These~     investigations showed us the negative effects of pain in the neonatal period. Our research~     concerns the choice of analgesics for the premature newborn during a heel lance. Newborns~     with a gestational age of 32-37 weeks are randomly assigned over three groups. They can~     receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or~     sucrose.~      The primary objective of the Amphia Premature Infant Pain study, is to investigate whether~     there is a difference in PIPP-scores in premature newborns who undergo a heel lance,~     receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in~     newborns receiving breast milk compared to sucrose. And the investigators presume that breast~     feeding has the same analgesic effect as giving supplemental breast milk.~   "
174855|NCT01276353|"~     The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the~     currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with~     severe Alzheimer's disease.~   "
174856|NCT01276340|"~     The investigators performed a prospective analysis of 450 women with stress, urge and mixed~     incontinence in order to assess the health-related quality of life (Contilife® questionnaire)~     and the objective cure rate after two months of electrical stimulation (Keat® stimulator).~     Management of urinary incontinence with the Keat® stimulator could given an improvement in~     the quality of life and a good rate of satisfaction without side effect.~      Objective cure is as good as subjective improvement especially in urinary stress~     incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the~     bew first-line non surgical treatment for female urinary incontinence.~   "
174857|NCT01276327|"~     The objective of the current study is to establish the bioequivalence of linagliptin/~     pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and~     pioglitazone administered together.~   "
174858|NCT01276314|"~     Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has~     the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to~     the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%).~     Hypersensitivity syndrome, sometimes called Drug Reaction with Eosinophilia and Systemic~     Symptoms (DRESS), has a mortality rate evaluated at about 10%. The aims of this project are~     (1) to compare the effect of treatment between systemic steroid and anti-TNF-α. Including~     skin healing time, beginning of re-epithelialization time, internal organ recovery time,~     mortality rate, adverse events and (2) to investigate the molecular mechanism of severe~     cutaneous adverse reaction after anti-TNF-α treatment.~   "
174859|NCT01276301|"~     Relative bioavailability of BI 10773 given alone and together with verapamil~   "
174860|NCT01276288|"~     The primary objective of the study is to investigate the effect of BI 10773,~     hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. Furthermore~     the pharmacodynamic and pharmacokinetic interactions between BI 10773 and diuretics should be~     assessed.~   "
174862|NCT01276262|"~     A crossover study to assess the effect of repeated doses of fostamatinib on the levels of~     oral contraceptive (Microgynon® 30) in the blood of healthy female subjects. The study will~     consist of a screening period of up to 35 days, followed by 2 treatment periods (28 days~     each) of an oral contraceptive (Microgynon® 30) in the absence and presence of fostamatinib.~     The study will also evaluate the safety and tolerability of fostamatinib in combination with~     an oral contraceptive~   "
174863|NCT01276249|"~     The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the~     clinical knowledge base by including 'real world' subjects.~   "
174864|NCT01276236|"~     The purpose of this study is to determine whether Maraviroc is effective in the treatment of~     Kaposi's Sarcoma (KS), when it does not remit with standard antiretroviral drug therapy.~   "
174865|NCT01276223|"~     The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective~     in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog~     Scale (VAS) discomfort score.~   "
174866|NCT01276210|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth or by blocking blood flow to the tumor. Stereotactic~     radiosurgery (SRS) may be able to send x-rays directly to the tumor and cause less damage to~     normal tissue. Giving sorafenib tosylate together with SRS may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and the best dose of sorafenib~     tosylate when given together with SRS in treating patients with brain metastases~   "
174867|NCT01276197|"~     The purpose of this study is to determine if patients with high blood pressure are better~     able to control their blood pressure after watching a DVD about blood pressure.~   "
174868|NCT01276184|"~     Human papillomavirus (HPV) is the most common sexually transmitted disease among adolescent~     females in the United States. Our primary objective is to determine if Short Message Service~     (SMS) text message reminders increase adherence to the recommended 3 dose schedule for~     Gardasil compared to usual care in an outpatient clinic setting. Secondary objectives of this~     study are: 1) to demonstrate the feasibility of using SMS text message reminders to increase~     adherence with Gardasil vaccination; and 2) to assess satisfaction and acceptability of text~     message reminders compared to telephone reminders among women who receive the text message~     arm of the intervention. The investigators hypothesize that receiving SMS text message~     reminders will increase adherence to the recommended 3 dose schedule for Gardasil compared to~     usual care.~   "
174869|NCT01276171|"~     Radial arterial cannulation is a common invasive procedure for real-time measurement of~     arterial blood pressure. Placement of the arterial catheter using conventional palpation is~     often relatively easy and quick, but this is not always true. A relatively new method for~     direct visualization of the artery is the use of two-dimensional ultrasound. This technique~     allows cannulation of the artery to take place under real-time visualization and may increase~     the success rate of first time pass of the needle. Another technique utilizing Doppler has~     also proven to be effective in cannulating the radial artery. This technique utilizes changes~     in acoustic pitch as the probe passes directly over the artery. The primary objective of this~     study is to compare the first attempt success rate for radial artery cannulation among the~     palpation, Doppler and U/S guided technique when applied by trainees. Secondary outcomes~     include: success rate within 5 minutes, successful, number of attempts required, and~     correlation between success rate and operator experience for successful cannulation of the~     radial artery.~   "
174870|NCT01276158|"~     This prospective randomized study was designed to compare ultrasound guided technique with~     Doppler assisted technique for radial arterial cannulation in infant and small children.~   "
174871|NCT01276145|"~     Subjects in this study have recently had or are scheduled for a coronary angiography as part~     of their normal, routine medical care. This procedure uses x-ray imaging to see the inside of~     the heart's blood vessels.~      This research study will evaluate the possible relationship between erectile dysfunction and~     vascular disease (diseases of the veins). In order to look at this possible relationship,~     subjects will complete a questionnaire which will ask questions regarding their sexual~     activity. Additionally, we will gather information from their medical records and take extra~     images during the coronary angiography procedure.~   "
174872|NCT01276132|"~     Subjects in this study have recently had or are scheduled for a (percutaneous coronary~     intervention) PCI as part of their normal, routine medical care. This procedure should~     restore the blood flow in the vessels of the heart.~      Recent studies have shown that stable patients who undergo PCI and are discharged home after~     4 hours of observation do not suffer any more complications compared to patients who stay in~     the hospital overnight. In addition, studies suggest that patients express increased~     satisfaction at being discharged after 4 hours.~      The University of Chicago is one of the first US medical centers to institute a formal~     program of same-day discharge after PCI. This study will seek, through a analysis of medical~     information and satisfaction questionnaires, to assess whether this particular same-day~     discharge program can improve patient satisfaction and preserve patient safety.~   "
174873|NCT01276119|"~     To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by~     intravenous infusion (iv) and subcutaneous (sc) injection.~   "
174874|NCT01276106|"~     This is a 24-week randomized placebo-controlled study to investigate the effect of an oral~     IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on~     different background diabetes therapies.~   "
174875|NCT01276093|"~     The purpose of the study is to demonstrate that in patients of 70 years or older with~     symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF~     ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of~     AF.~   "
174876|NCT01276080|"~     This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose~     crossover study was conducted to compare the relative bioavailability of equal doses of the~     test and reference products under non-fasted conditions.~   "
174877|NCT01276067|"~     This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose~     crossover study was conducted to compare the relative bioavailability of equal doses of the~     test and reference products under fasted conditions.~   "
180442|NCT01203124|"~     The study will investigate how the dose of AZD8848 and the dosing frequency will affect the~     immunological/inflammatory response by measuring the production of biomarkers in blood and~     nasal lavage.~   "
174878|NCT01276054|"~     Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity~     of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or~     axillary lymph node biopsy with or without axillary reverse mapping works in reducing~     incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer~   "
174879|NCT01276041|"~     The purpose of this study is to see if a combination of drugs can help to treat this type of~     cancer. One drug is a chemotherapy agent called paclitaxel (Taxol®). Paclitaxel will be given~     every week through the vein. Although the weekly schedule of paclitaxel is not included in~     the label, the schedule and dose of weekly paclitaxel have been studied and have been proven~     to be more effective than an old standard schedule. The other two work against HER2. One is~     called trastuzumab (Herceptin®) and it is commonly given to women with early HER2 positive~     breast cancer or with advanced HER2 positive breast cancer that has spread to other parts of~     the body. Trastuzumab will be given through the vein every 3 weeks (or every week at the~     doctor's discretion). The third drug, pertuzumab, is an investigational drug. It has not been~     approved by the Food and Drug Administration. It has been given in studies to over 800~     people. It has been effective in treating HER2 positive breast cancer. Pertuzumab will be~     given every 3 weeks through the vein. This study is looking at the effectiveness of these~     three drugs together.~   "
174880|NCT01276028|"~     The primary purpose of this study is to determine the effectiveness of acupuncture for~     treating vasomotor and other symptoms associated with menopause as acupuncture is generally~     practiced in the real world setting and to obtain a comprehensive assessment of use~     patterns and symptom relief over time. This study will allow us to determine treatment~     patterns recommended by practicing acupuncturists, adherence to these treatments, and the~     effectiveness of different treatment patterns for reducing hot flashes. Results of this study~     will provide meaningful information to women in terms of number and frequency of acupuncture~     treatments likely to be needed to reduce hot flashes.~   "
174881|NCT01276015|"~     Objectives. To study the short-term neurophysiological and clinical outcome of botulinum~     toxin type A(BoNT-A), injected at standard doses, and assess toxin spread to neighboring~     uninjected muscles in children with cerebral palsy.~      Subjects and methods. The investigators studied 18 ambulatory children with dynamic equinus~     foot deformity (mean age 6.1 years). The gastrocnemius muscle on the affected side was~     injected with BoNT-A (Dysport, range from 8.9-19.4 U/kg). As the primary neurophysiological~     outcome measure, compound muscle action potential (CMAP) areas were assessed in the lateral~     gastrocnemius (LG) and tibialis anterior(TA) muscles on the treated and untreated side before~     BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections. Clinical scales~     were assessed and video gait was analyzed at all three time points.~      Results. In all patients, CMAP areas recorded from the LG and TA muscles on the treated side~     decreased significantly from pre-injection values at T10 (p<0.05) and T30 (p<0.002).~     Assessment at both time points after injections also showed that ankle spasticity had~     diminished (p<0.05), equinus foot excursion increased (p<0.05), and functional gait improved~     (p<0.05).~      Conclusion. Although BoNT-A injected at standard doses improves gait in children with spastic~     equinus foot the toxin spreads to uninjected leg muscles. BoNT-A treatment for cerebral palsy~     therefore needs individualizing according to the child's clinical features.~   "
174882|NCT01276002|"~     The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and~     persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized~     studies have been conducted on the influence of pancreatic duct stenting for the patients`~     benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively~     in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic~     duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical~     recovery and avoidance of recurrence of pancreatic pseudocysts.~   "
174883|NCT01275989|"~     Randomized Controlled Trial found that levels of stress and anxiety of students ITIO, Ear and~     effective in reducing these levels. The LSS questionnaire and IDATE state were applied~     before, two months and two and a half months after the start of the applications, the STAI~     trait was applied once prior to the sessions. The sample comprised 56 individuals who had~     higher levels of stress above the average LSS 100 students who answered the questionnaires.~     Participants were divided randomly into three groups: control group with 15 patients without~     care, intervention group with 20 individuals using specific points for treatment and Group~     Sham at 21 points using individuals without indication for treatment of anxiety and stress.~     The results showed that the sham points decreased anxiety levels of participants.~   "
174884|NCT01275976|"~     Trauma and major operation are associated with an excessive inflammation reaction due to~     tissue injury. This overwhelming immune response is considered to be a major risk factor in~     the pathogenesis of late inflammatory complications such as acute respiratory distress~     syndrome (ARDS), multiple organ dysfunction syndrome (MODS) and sepsis.~      The investigators hypothesize that administration of C1-esterase inhibitor (C1-INH) will~     attenuate the humane inflammatory response and, thereby, reduce the risk of inflammatory~     complications due to surgical interventions in trauma patients with a femur or pelvic~     fracture~   "
174885|NCT01275963|"~     Assessment of left ventricular systolic function is the most frequent indication for routine~     echocardiography. Qualitative eyeball method and biplane modified Simpson's rule, both~     measuring radial ventricular function, are the currently recommended methods to meet this~     challenge. Due to the complexity of the myocardial architecture, global left ventricular~     function also has longitudinal and torsional components.~      The aim of this study is to evaluate new echocardiographic parameters for longitudinal left~     ventricular function. A special focus is set on strain imaging by speckle tracking, which is~     a relatively new technique. Patients with different cardiac pathologies (e. g. dilated~     cardiomyopathy, coronary artery disease, diastolic dysfunction) will be included and compared~     to healthy individuals.~   "
174886|NCT01275950|"~     The Project aims at enlisting the outlets selling tobacco in any form and enlisting the~     tobacco based advertisements (Direct and Surrogate) directed towards the community, within~     100 yards of the selected educational institutes and studying their impact on the students of~     that institute. This will further be followed by an intervention program directed at the~     outlet owners which entails creating awareness about the harmful effects of tobacco and the~     existing bill and thereby assessing any change in Knowledge, Attitude and Practice. The~     results thus obtained will facilitate implementation of the existing Bill.~   "
174887|NCT01275937|"~     A bleeding peptic ulcer remains a serious medical problem with significant morbidity and~     mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality~     in patients with bleeding peptic ulcers and is now recommended as the first hemostatic~     modality for these patients.~      In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after~     endoscopic therapy has been endorsed in some studies. However, low dose of PPI has also been~     supported in the management of these patients.~      The investigators enroll 130 patients with active bleeding or nonbleeding visible vessels in~     this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All~     patients receive successful endoscopic therapy with heater probe or hemoclip placement.~      In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the~     patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65),~     160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40~     mg nexium orally daily for two months.~      The primary end point is recurrent bleeding before discharge and within 14 days. At day 14,~     volume of blood transfused, number of surgeries performed, and the mortality rates of the two~     groups are compared as well.~   "
174888|NCT01275924|"~     Syndesmotic injuries are common and often associated with unstable ankle fractures. The most~     common treatment is with a syndesmotic screw through the fibula and tibia which is later~     removed, usually after 10-12 weeks. The Tightrope Syndesmosis Repair Kit (Arthrex; Naples,~     Florida). is used for the same indication, it consists of a heavy suture placed across the~     syndesmosis which has been looped and tightened through cortical button anchors on either~     side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial~     compares these two treatment methods for syndesmotic injuries of the ankle.~   "
174889|NCT01275911|"~     In this randomized observer-blinded trial the analgesic efficacy of intravenous esmolol, as~     alternative to intraoperative opioids, is tested in patients undergoing laparoscopic~     prostatectomy and upper gastrointestinal surgery (such as Nissen fundoplication). The purpose~     of this study is to determine whether intravenous esmolol improves postoperative analgesia~     and accelerate the surgical recovery. We hypothesize that patients receiving intravenous~     esmolol will consume less analgesic in the postoperative period, will have less~     opioid-related side effects and will recover their functional status faster then patients~     receiving intravenous esmolol.~      Patients will be stratified according to the type of surgical procedure in 2 arms: 40~     patients with prostate cancer and undergoing elective laparoscopic prostatectomy, and 40~     patients with gastro-esophageal reflux undergoing upper gastrointestinal surgery (Nissen~     funduplication) will be enrolled.~      Patients will receive total intravenous anesthesia with propofol and esmolol (Esmolol group,~     n=20 in each arm) or propofol and remifentanil (Remifentanil Group, n=20 in each arm).~   "
174890|NCT01275898|"~     Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are~     available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to~     influence cerebral oxygenation. Litte is known about the influence of prone position and head~     down position on cerebral oxygenation. The investigators hypothesize that these positions~     influence cerebral oxygenation. Further the investigators presume that the two cerebral~     oximeters INVOS and ForeSight provide comparable oxygenation data.~   "
174891|NCT01275885|"~     The aims of the present study are to evaluate the concentrations of vitamin D in the plasma~     and of calcium in the plasma and in the urine as well as to evaluate bone mineral density~     using peripheral quantitative computed tomography (pQCT), after supplementation of vitamin D~     with 30µg (1200 IU) and 40µg (1600 IU), in comparison with currently recommended~     supplementation of vitamin D with 10µg (400 IU). In this pilot study supplementation is given~     to infants from 2 weeks of age to 3 months of age.~   "
174892|NCT01275872|"~     The purpose of this study is to determine whether Guided Imagery and Progressive Muscle~     Relaxation techniques are effective in the management of pain, fatigue, nausea-vomit, anxiety~     and depression in patients with either prostate or breast cancer.~      This study includes a total of 200 patients with prostate and breast cancer randomly assigned~     to either a control or intervention group.~      The intervention group received in total 4 sessions of Guided Imagery (protocol floating on a~     cloud) and Progressive Muscle Relaxation (breathing exercises and use of 11 groups of muscle~     progressively tensing and relaxing).~      Measurements included the assessment of pain, fatigue, nausea-vomit, depression, anxiety and~     quality of life. Additionally, saliva samples were collected prior and after the sessions as~     to assess saliva cortisol and saliva α-amylase.~      The same measurements were received by the patients of the control group as to allow~     comparisons.~   "
174893|NCT01275859|"~     Cross-talk between epidermal growth factors and the ER occurs at multiple levels and seems to~     play a crucial role in breast cancer progression and endocrine resistance.Combined~     HER1/HER2-targeted therapy with aromatase inhibitors for ER-positive and HER-2 positive~     postmenopausal breast cancer might enhance response and block emergence of endocrine~     resistant tumor.~   "
174894|NCT01275846|"~     This purposed of this study is to ascertain if the implementation of remote patient~     management systems utilizing American Heart Association (AHA) guideline-based heart failure~     protocols and educational content can improve the management of patients with congestive~     heart failure.~   "
174895|NCT01275833|"~     The objective of the trial is to observe the effects of restoring atrioventricular (AV)~     synchrony in subjects with prolonged PR intervals. This will be assessed both acutely and~     chronically using echocardiographic and functional measurements.~   "
174896|NCT01275820|"~     The purpose of this study is to evaluate how an investigational food product affects a~     healthy person's blood sugar and insulin levels.~   "
174897|NCT01275807|"~     The purpose of the investigators study is to create the evidence of effectivness on~     climacteric syndrome in patients affected by breast cancer, by acupuncture added to the~     standard care (self care).~   "
174898|NCT01275794|"~     The purpose of the study is assessment of glycemic control and physicians satisfaction with~     results of DM2 OAD monotherapy~   "
174899|NCT01275781|"~     The purpose of this study is to assess distribution, metabolism, and excretion of~     radio-labelled AZD9742 administered as a 2-hour infusion to healthy male volunteers.~   "
175115|NCT01272973|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and~     pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male~     subjects~   "
174900|NCT01275768|"~     Patients with malignant obstructive jaundice (cancer of head of pancreas and~     cholangiocarcinoma) generally have a very poor prognosis with less than 20% patients having~     resectable disease at presentation. These patients also have a very poor quality of life with~     a life expectancy of 6-8 months. Jaundice associated with pruritus, poor appetite,~     malabsorption and loss of weight and cholangitis is the most common and troublesome problem.~     Placement of metallic stents has been the standard of care for patients with unresectable~     disease. However, about 50% of these stents get blocked in 6-8 months. Use of endoscopic~     Radio-frequency Ablation (RFA) prior to placement of metal stents may increase the patency of~     these stents~   "
174901|NCT01275755|"~     Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and~     reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI~     tract. The most common symptoms associated with the effects of opioids are constipation and~     nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of~     long-term opioid therapy.~      The primary objective of this study was to compare ADL5945 once daily, a MOR antagonist, with~     placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term~     opioid therapy for chronic noncancer pain.~   "
174902|NCT01275742|"~     Heart failure (HF) affects 5 million people in the US and is the most common cause of~     hospitalization in elderly adults. One-third of patients who are hospitalized with HF have~     major depression. Depressed HF patients have double the rates of morbidity and/or mortality~     and worse health-related quality of life than non-depressed HF patients. The investigators~     previous pilot research suggests that a brief Cognitive Therapy (CT) intervention may improve~     short-term cardiac survival among depressed hospitalized HF patients compared to~     non-depressed HF patients who received usual care. Therefore, the investigators will conduct~     a larger study to evaluate the effects of the intervention on longer cardiac event-free~     survival, symptoms of depression, health-related quality of life, and stress levels in~     patients with HF. The investigators hypothesize that patients in the intervention group will~     experience longer cardiac event-free survival, lower levels of depressive symptom, better~     health-related quality of life, and lower salivary cortisol levels at follow-up than patients~     who receive usual care.~   "
174903|NCT01275729|"~     The primary objective is to safely determine if the investigators can identify the severity~     of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the~     investigators will draw blood and urine for novel and standard biomarkers. The investigators~     are attempting to determine if these biomarkers can forecast the course of AKI (need for~     dialysis, death and renal recovery). The investigators seek to determine how well physicians~     caring for those with AKI can predict the clinical course compared to these novel biomarkers~     of AKI and if there is an association between clinical course and 3 year patient outcomes.~   "
174904|NCT01275716|"~     Subjects in this research study have Coronary Artery Disease (CAD). This occurs when there is~     a build-up of fatty material in the wall of the heart arteries that causes narrowing of the~     arteries. This could lead to chest pain, a heart attack, weakening of the heart and/or~     permanent damage to the heart. As part of their normal routine care, subjects had or will~     have a Percutaneous Coronary Intervention (PCI) to restore the blood flow in the arteries of~     their heart. During a PCI procedure, pictures are taken of the arteries before and after the~     treatment of the narrowing in the arteries. These pictures are acquired through angiography~     which is a way to produce X-ray pictures of the inside of arteries.~      After a PCI procedure, there is a possibility for narrowing of the arteries to return. The~     likelihood of this happening can be greatly reduced by lifestyle changes and adhering to~     heart medication regimens. It is part of normal, routine care for CAD patients to be given~     written and verbal information on how to lead a heart healthy lifestyle and to take heart~     medications properly.~      In this research study, the investigators will show half of the patients their before and~     after images of their heart arteries where the narrowing occurred and was treated. The other~     half of the patients will not be shown these images. Both groups will still receive~     information about lifestyle and medications as part of their normal, routine care. At the end~     of this study, the investigators will compare both groups to see if there are any differences~     in making lifestyle changes and taking heart medications properly. Additionally, the~     investigators would also like to see if there are any resulting differences in the amount of~     hearts attacks or other heart related medical events.~   "
174905|NCT01275703|"~     Subjects in this study have been diagnosed with pulmonary hypertension and their doctors have~     referred them for an exercise test as part of their normal, routine care. The exercise test~     will either be a treadmill test or a 6 minute walk test. During a treadmill test, a patient~     typically walks on a treadmill while their heart is monitored using an electrocardiogram,~     which records the electrical activity of the heart through 10 small electrode patches~     attached to the skin of the chest, arms and legs. Additionally, heart rate and blood pressure~     are monitored throughout the test. A 6-Minute Walk test requires patients to walk for up to 6~     minutes to determine how far they can go in order to measure the heart function related to~     exercise.~      The purpose of this study is to measure internal heart pressures using a device called~     Noninvasive Cardiac Output Monitoring (NICOM) during an exercise test. Normally heart~     pressures are measured during invasive (meaning that doctors have to go inside the body using~     a needle or surgery) heart procedures. The NICOM device is non-invasive which means the~     investigators do not have to go inside the body to obtain the heart pressure measurements. In~     this study, the investigators will evaluate the non-invasive measurements provided by the~     NICOM device during the exercise test and see how it relates to information from some of~     subjects' past heart procedures. This research is being done to devise better, less invasive~     ways to assess disease severity, track disease progression and evaluate response to therapy.~      The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart~     pressures. This device is usually used when a patient can't undergo a right heart~     catheterization. In this study, the investigators are using the device to gather heart~     pressure measurements for research during the exercise test that is scheduled as part of the~     subjects' normal, routine care. The research data is being used to devise better, less~     invasive ways to assess disease severity, track disease progression and evaluate response to~     therapy. The NICOM device is made by Cheetah Medical.~   "
174906|NCT01275690|"~     Subjects in this study have been diagnosed with pulmonary hypertension (PH) and their doctors~     have referred them for a right heart catheterization (RHC). Heart catheterization involves~     inserting an IV (a needle with a small tube) into a vein in the neck. A long, narrow tube,~     called a catheter, is guided through the IV into the blood vessel and guided to the heart~     (sometimes this procedure can be done through a vein in the groin instead). Once the catheter~     is in place, small instruments can be inserted into the catheter to measure the pressures in~     different areas of the heart. These measurements can help the doctor diagnose possible~     problems with the heart functioning.~      The purpose of this study is to evaluate the measurements provided by a device, called~     Noninvasive Cardiac Output Monitoring (NICOM). The NICOM device is non-invasive which means~     the investigators do not have to go inside the body to obtain the heart pressure~     measurements. While the device has been approved for use in any patient, it remains possible~     that patients with PH will have differences in the way the device calculates measurements. In~     this study, the investigators will compare the in-the-body (right heart catheterization)~     measurements to the non-invasive, outside-body measurements provided by the NICOM device to~     evaluate any differences.~      The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart~     pressures. This device is usually used when a patient can't undergo a right heart~     catheterization. In this study, the investigators are using the device to gather heart~     pressure measurements for research during the right heart catheterization procedure that is~     scheduled as part of the patients' normal, routine care. The research data is being used to~     devise better, less invasive ways to assess disease severity, track disease progression and~     evaluate response to therapy. The NICOM device is made by Cheetah Medical.~   "
174907|NCT01275677|"~     This randomized phase III clinical trial studies chemotherapy with or without trastuzumab~     after surgery to see how well they work in treating women with invasive breast cancer. Drugs~     used in chemotherapy work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill~     more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. It is not yet known~     whether combination chemotherapy is more effective with trastuzumab in treating breast~     cancer.~   "
174908|NCT01275664|"~     This clinical trial is studying how well granisetron, aprepitant, and dexamethasone work in~     preventing nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or~     stage IV ovarian cancer. Granisetron patch, aprepitant and dexamethasone may help lessen or~     prevent nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or~     stage IV ovarian cancer.~   "
174909|NCT01275651|"~     This research trial studies biomarkers in bone marrow and blood samples from patients with~     prostate cancer treated with ketoconazole. Studying samples of bone marrow and blood from~     patients with prostate cancer in the laboratory may help doctors learn more about changes~     that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.~   "
174910|NCT01275638|"~     Despite the new developments in sepsis treatment, mortality rate is still high. Discussions~     on steroid treatment in sepsis are going on. In this study, we aimed to investigate the~     effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis~     on prognosis in patients with sepsis.~   "
174911|NCT01275625|"~     One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and~     lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy~     and safety of this combination in a Russian population of patients.~   "
174912|NCT01275612|"~     This is a pilot, explorative, study to test the feasibility and safety of systemic infusion~     of donor ex-vivo expanded Mesenchymal Stem Cells to repair the kidney and improve function in~     patients with solid organ cancers who develop acute renal failure after chemotherapy with~     cisplatin.~   "
174913|NCT01275599|"~     The purpose of this study is to investigate the drug-drug interaction potential between~     telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will~     help to determine whether buprenorphine dose adjustments are necessary for patients who are~     concomitantly treated with telaprevir.~      Telaprevir, in combination with other antiviral agents, is being investigated for the~     treatment of chronic hepatitis C virus infection. Buprenorphine/naloxone is used for~     maintainance therapy in patients with opioid dependence.~   "
174914|NCT01275586|"~     The purpose of this Pilot Study is to determine if NF1 patients with plexiform neurofibromas~     treated with Tasgina® respond to therapy.~   "
174915|NCT01275573|"~     Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain~     perception was altered in Parkinson's disease patients and could be related to nociceptive~     cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an~     electrophysiological tool which can modify cortical excitability. Its efficacy was~     demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In~     this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be~     evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain~     free Parkinson's disease patients. Each group will receive a high frequency Repetitive~     Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of~     one week.~      The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session~     with an infraliminary intensity on the primary cortical motor, modulating nociceptive~     cortical areas activity, could modify the nociceptive threshold perception in Parkinson's~     patients.~   "
174916|NCT01275560|"~     The objectives of this work are: 1/to estimate the frequency of a positive glucose breath~     test in favour of a small intestinal bacterial overgrowth in a population of patients~     consulting for gaz incontinence by comparison to a population of control subjects; 2/to~     estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case~     of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz~     incontinence~   "
174917|NCT01275547|"~     Introduction~      Ketamine is an old and generally well accepted analgesic used in the intra- and perioperative~     setting. Several studies demonstrated the effectiveness of ketamine in the postoperative~     setting.~      A new formulation of S-ketamine as an intranasal spray device was tested in our hospital in 8~     healthy volunteers (unpublished data, EKBB 351/08). 20 mg of S-ketamine were administered~     intranasally and compared with S-ketamine i.v. and i.m.. None of the volunteers had serious~     adverse effects or complications. A preliminary data analysis shows a clear analgesic effect~     and good absorption of the intranasal S-ketamine.~      As a next step we would like to investigate the effect of S-ketamine intranasal spray~     combined with midazolam intranasal spray in a group of postoperative spinal surgery patients.~     The rational for the combination of intranasal S-ketamine and midazolam is the well known~     midazolam antagonising effect of ketamine induced psychomimetic adverse effects. Furthermore~     we know from other studies (EKBB 106/06) that midazolam intranasal spray has relaxant and~     anxiolytic effects. As far as we know, this is the first study which will examine the~     combination of S-ketamine and midazolam intranasal sprays in adult patients.~      Study work plan~      This prospective, randomized, double-blinded non inferiority study will address pain ratings~     and patient satisfaction in a postoperative setting in two treatment scenarios:~        1. Alternating S-ketamine intranasal unit-dose spray (6 mg per dose) with midazolam~          intranasal spray (0.75 mg per dose) patient controlled application with a lock-out~          interval of 20 minutes between two applications and placebo patient controlled analgesia~          (PCA) with a lock-out interval of 12 minutes with saline 0.9% i.v. for 72 hours or until~          40 unit-dose sprays are delivered~        2. PCA with 2 mg morphine with a lock-out interval of 12 minutes i.v. with placebo~          intranasal spray (saline 0.9% + chitosan) with a minimum lock-out interval of 20 minutes~          for 72 hours or until 40 unit-dose sprays are delivered~      Patient number~      We will examine 36 patients, 18 patients in each group. The study duration for an individual~     patient will be at latest 72 hours, the total study duration is 4 to 5 months.~      Study importance~      An intranasal spray is an ideal application form for surgery patients, either in- or~     outpatients. On the other hand, ketamine and S-ketamine is quite often used in the~     perioperative setting as a rescue analgesic. In higher doses it could be used as an emergency~     tool in emergency prehospital medicine. In the perioperative setting it is important to~     evaluate the efficacy and safety of S-ketamine intranasal spray combined with midazolam~     intranasal spray in patients.~      If our study shows that S-ketamine intranasal spray is effective as an analgesic and has good~     patient acceptance, S-ketamine intranasal spay could be considered as an alternative,~     completely non-invasive analgesic procedure in a postoperative outpatient setting. As a~     consequence development of a nasal multidose-applicator combining S-ketamine and midazolam~     would be of interest.~   "
174930|NCT01275378|"~     The purpose of this study is to compare the effectiveness of two care models on ADHD~     outcomes: one, a model of basic care management and structured communication with~     specialists, consistent with conventional descriptions of a patient-centered Medical Home;~     and another, which combines the Medical Home with theory-based care management strategies to~     address common reasons for ADHD treatment failure.~   "
180800|NCT01198405|"~     To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined~     with guideline-driven standard treatment on patients documented with and/or at high risk of~     coronary artery disease.~   "
174918|NCT01275534|"~     In the study PROVIVO, a patient reported outcome instrument consisting of items from the~     PRO-CTCAE item bank measuring symptom experience of long-term survivors after allogeneic~     hematopoietic stem cell transplantation (SCT) will be developed. The instrument development~     is based on cognitive patient interviews, a survey of hematology experts and a literature~     review. In a subsequent cross-sectional study phase, the instrument will be validated in a~     sample of 300 allogeneic stem cell recipients and by the use of additional self report~     instruments it will be possible to explore how subjective symptom experience, problems in~     self-management and presence of late effects are connected.~   "
174919|NCT01275521|"~     BPH is very common in elderly men, it is a stromal as well as epithelial invasion of the~     prostatic gland. Due to an imbalance between growth and apoptosis cellular mechanisms that~     are not fully elucidated. It is the same for symptomatology and urodynamic obstruction~     without clear identification of the part which is due to static phenomena (volume increase)~     and dynamic reports (α 1-receptor action). That explains the multiplicity of treatments and~     the difficulty of therapeutic indications between monitoring, medical treatment, and surgical~     operation. Experimental studies of BONT-A intra prostatic injection on animal and human~     models, have shown efficacy in BPH cell apoptosis, decrease in cell growth and decline in the~     number of adrenergic α1 receptors.~      Many studies in humans show therapeutic efficacy leading to a possible use of BONT-A as mini~     invasive treatment of symptomatic BPH, as an alternative to medical or surgical treatment.~      PROTOX study proposes to evaluate tolerance and effectiveness of the intra-prostatique BONT-A~     injection in the treatment of symptomatic BPH.~   "
174920|NCT01275508|"~     The scientific objective of the project is to evaluate if the topical administration of~     Fluoresceinisothiocyanate (FITC)-Adalimumab during the endomicroscopic examination of the gut~     in Crohn's disease (CD) patients shows an acceptable safety profile. Another objective is to~     explore whether the use of FITC-Adalimumab as a predictive biomarker might reliably predict~     patient response to Adalimumab therapy and hence enable optimized utilization of this~     treatment option.~   "
174921|NCT01275495|"~     The purpose of this study is to test the efficacy of the revised Telephone Assessment and~     Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR)~     intervention in family caregivers of stroke survivors. We will also test if TASK II~     intervention effects on primary outcomes (depressive symptoms, caregiving-related negative~     life changes, unhealthy days) are mediated through effects on secondary outcomes (task~     difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and~     ISR interventions will also be explored.~   "
174922|NCT01275482|"~     The purpose of this study is to determine whether Transverse Friction Massage (TFM) in Latent~     Myofascial Trigger points (MTrP) is more effective making this technique in two different~     ways.~   "
174923|NCT01275469|"~     The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in~     improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and~     abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of~     oral doses of GFT505 during 35 days.~   "
174924|NCT01275456|"~     This clinical validation study is aimed at testing the efficacy of a new environmental~     challenge chamber (ECC) to induce symptoms of allergic rhinitis in patients allergic to house~     dust mite. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom~     Score (TNSS), allowing for determine whether the challenge is dose dependent and~     reproducible.~   "
174925|NCT01275443|"~     TMC278 (also called rilpivirine) is a new drug being developed to treat HIV. Usually TMC278~     is taken as a tablet, by mouth, once a day, but a 'long acting' formulation has been~     developed so the drug stays in the bloodstream for a longer time - this allows the drug to be~     given by injection and less often. It is hoped that this injectable version of the drug may~     be used to help prevent HIV transmission in the future by giving it to people who are at risk~     of HIV. This is similar to the way travellers to areas with malaria may take antibiotics to~     prevent infection. The investigators aim to investigate the feasibility of using TMC278 as a~     preventative medication by performing this study.~      The purpose of this study is to investigate the levels of drug which can be measured in the~     blood, as well as the tissues and fluids of the rectum (the lowest part of the bowels just~     before the opening of the anus) as well as the safety of the drug and how well tolerated it~     is when given as a single dose. In this study, the investigators will not be investigating~     whether the drug prevents HIV so the investigators will recruit people who are HIV negative,~     and whose lifestyle does not put them at risk of becoming infected before or during the~     study.~      If the study shows the drug is well tolerated and produces appropriate levels of the drug (in~     the bloodstream and the rectal compartment) to suggest that it could be effective, it will~     help design future studies looking at preventing HIV.~   "
174926|NCT01275430|"~     Phase I~        -  determine the location of the peripherally inserted central catheter (PICC) tip upon~          observation of maximum p-wave amplitude~      Phase II~        -  determine the precision of PICC placement in the Sherlock 3CG group versus the standard~          PICC placement~   "
174927|NCT01275417|"~     We are expecting that there are remarkable differences location at BaiHui(GV20) or~     Houding(GV19)showing from same person in our study.~   "
174928|NCT01275404|"~     The investigators know that treatment for prostate cancer and erectile dysfunction can impact~     sexual health and quality of life. They want to learn how the treatment affects one's~     emotional and social well-being.~      They have developed a new type of counseling. Cancer patients seek counseling for lots of~     reasons. It often helps them cope because they can express their feelings with a trained~     professional. They hope that this counseling will teach patients skills that they can use to~     comply with erectile treatment programs, improve their sexual health and quality of life.~     These skills may also improve physical and emotional well-being. As part of this study they~     will ask the patient to provide feedback on the proposed counseling.~   "
174929|NCT01275391|"~     In this project we will conduct a pilot study of a brief intervention to reduce teen tobacco,~     alcohol and drug use that primary care dental practitioners can provide in their offices.~   "
174931|NCT01275365|"~     This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial~     in community dwelling, older men, 65 years of age or older, who have mobility limitation and~     low protein intake. The study will have a 2 X 2 factorial design, which will allow us to~     investigate the effects of dietary protein intake and testosterone separately and together.~   "
174932|NCT01275352|"~     This study will consist of middle-aged Caucasian non-failing subjects with high blood~     pressure who are homozygous for a gene that confers increased risk of developing heart~     failure, the Glycine 83 variant of the Ka renal chloride channel (ClC-Ka Gly/Gly 83), or~     middle-aged Caucasian non-failing hypertensive subjects who lack the heart failure risk gene,~     the wild-type Arginine 83 Ka renal chloride channel (ClC-Ka Arg/Arg 83). Subjects on standard~     therapy for high blood pressure with an angiotensin converting inhibitor (ACEI) or~     angiotensin receptor blocker (ARB) will be randomized to additional treatment with eplerenone~     (an aldosterone antagonist) or placebo, and assessed for changes in echocardiographic left~     ventricular hypertrophy (LVMI). Secondary endpoints will assess left ventricular remodeling~     and other echocardiographic variables. The investigators hypothesize that subjects homozygous~     for the CLCNKA risk allele will have a greater response to eplerenone in terms of reductions~     in LVMI than those lacking the risk allele.~   "
174933|NCT01275339|"~     Currently, aortic stenosis (AS) is considered a surgical disease with no medical therapy~     available to improve any clinical outcomes, including symptoms, time to surgery, or long-term~     survival. Thus far, randomized studies involving statins have not been promising with respect~     to slowing progressive valve stenosis. Beyond the valve, two common consequences of aortic~     stenosis are hypertrophic remodeling of the left ventricle (LV) and pulmonary venous~     hypertension; each of these has been associated with worse heart failure symptoms, increased~     operative mortality, and worse long-term outcomes. Whether altering LV structural~     abnormalities, improving LV function, and/or reducing pulmonary artery pressures with medical~     therapy would improve clinical outcomes in patients with AS has not been tested. Animal~     models of pressure overload have demonstrated that phosphodiesterase type 5 (PDE5) inhibition~     influences nitric oxide (NO) - cyclic guanosine monophosphate (cGMP) signaling in the LV and~     favorably impacts LV structure and function, but this has not been tested in humans with AS.~     Studies in humans with left-sided heart failure and pulmonary venous hypertension have shown~     that PDE5 inhibition improves functional capacity and quality of life, but patients with AS~     were not included in those studies. The investigators hypothesize that PDE5 inhibition with~     tadalafil will have a favorable impact on LV structure and function as well as pulmonary~     artery pressures. In this pilot study, the investigators anticipate that short-term~     administration of tadalafil to patients with AS will be safe and well-tolerated.~   "
174934|NCT01275326|"~     Outbreaks of emerging and re-remerging infectious diseases are frequently reported~     internationally in recent years, mainly due to global climate change, close human-livestock~     contact in developing countries, and globalization. Thus prevention, monitoring and control~     of infectious diseases are in urgent need to protect public health. High exposure risk to~     various infectious agents in health care facilities is of special concern, especially to~     airborne and droplet-borne respiratory diseases. To protect the health of public and health~     care workers the investigators will conduct a study to monitor indoor air quality and~     essential infectious aerosols in hospital(s).~      A questionnaire survey will be used to evaluate the relationships between employees' health~     and measured indoor environmental factors. The investigators will also examine whether the~     current indoor air quality recommendation of their country can reasonably reduce the risk of~     hospital infection. In addition, simple infectious aerosol indices will be established for~     future environmental management and monitoring in health care facilities.~   "
174935|NCT01275313|"~     The proposed clinical trial is aimed at demonstrating the important role wheelchairs play in~     preventing pressure ulcers (bed sores). Although most pressure ulcers can be prevented, they~     are common in nursing home settings because their causes are difficult to identify. This~     clinical trial will guide practitioners toward improving preventive care practices by~     demonstrating how to effectively apply wheelchair and seat cushion technology.~   "
174936|NCT01275300|"~     We would like to see if aspirin could block niacin-induced flushing by analyzing blood and~     urine after taking aspirin.~      Phase I: 5 days of 81 mg aspirin/placebo followed by 600 mg Niacin, 2 week washout and 5 days~     taking the alternate. The order in which this is given will be randomized or assigned by~     chance.~      Phase II: One study week consisting of 5 days of taking 81 mg Aspirin, taken once daily,~     followed by a single dose of 600 mg Niacin on day 6.~      Phase III: 5 days taking 81 mg Aspirin/placebo, 10 day washout in between.~      Phase IV: Use of extended release niacin instead of instant release.~      Phase V: A Celebrex study is necessary to explore the contribution of Cox-2 to niacin induced~     flushing.~   "
174937|NCT01275287|"~     The purpose of this research study is to see if Eculizumab (Soliris®) can safely be used in~     addition to conventional therapy in patients with active ANCA (Antineutrophil Cytoplasmic~     Autoantibodies ) vasculitis and lead to a more rapid decrease in disease activity.~      ANCA vasculitis is an inflammation of the small vessels whereby ANCA antibodies~     inappropriately activate one's own white blood cells (neutrophils) and cause damage to the~     small blood vessels.~   "
174938|NCT01275274|"~     The purpose of this research study is to learn if adding all-trans retinoic acid (tretinoin)~     to conventional treatment of Anti- Neutrophil Cytoplasmic Autoantibodies (ANCA) vasculitis~     can decrease the level of disease activity.~   "
174939|NCT01275261|"~     The purpose of this study is to determine whether bladder catheterization can be safely~     avoided in patients admitted to the hospital with stroke using a nursing protocol, and~     whether this decreases the incidence of urinary tract infections. The investigators~     hypothesize that the protocol will be tolerated by nurses and patients, and that patients~     without bladder catheters will have fewer urinary tract infections and better outcomes.~   "
174940|NCT01275248|"~     This study is to assess the efficacy and safety of two doses of ondansetron (0.5 mg and 0.75~     mg) relative to placebo when administered twice daily as adjunctive therapy for adult~     patients with Obsessive-Compulsive Disorder (OCD) who have not adequately responded to~     treatment with a serotonin reuptake inhibitor (SRI).~   "
174970|NCT01274858|"~     The study will investigate topography of sensory changes late after lung cancer surgery~   "
174971|NCT01274845|"~     The aim of the study: to assess the effect of short-term mechanical ventilation with heliox~     in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance~     and respiratory function parameters.~   "
174972|NCT01274832|"~     The aim of this study is to investigate the impact of DBS not only no motor outcomes, but~     also on neuropsychological and psychiatric aspects and on quality of life in young patients~     with a short history of disease.~   "
174941|NCT01275235|"~     Individuals with a family history of type 2 diabetes mellitus (T2DM) are known to be at~     greater risk for the disease, and studies have shown that how the body responds to insulin,~     how the muscle creates energy, and the amount of fat stored inside skeletal muscle are often~     different in these individuals at a young age compared to people without a family history of~     the disease. The tendency to develop T2DM is influenced strongly by genetics; however,~     exposure to the surrounding environment may also play a role. The exposure to a diabetic~     environment while in the womb represents an altered nutritional exposure (high levels of~     circulating sugar, or glucose) that may affect how tissues important in regulating energy~     metabolism, such as the pancreas, liver, and skeletal muscle, develop. the purpose of this~     study is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen~     and skeletal muscle function in young adult sibling pairs who were raised together but who~     are discordant for intrauterine exposure to diabetes (i.e., the mother did ot have diabetes~     during pregnancy with the older sibling, but did have diabetes during pregnancy with the~     younger sibling).~   "
174942|NCT01275222|"~     This trial was a Phase I/II, non-randomized, open label, multi-center study, following a~     sequential 2- part design. The first part, Phase I, was designed to assess whether there is a~     pharmacokinetic interaction between Glivec/Gleevec (imatinib) and RAD001(everolimus) as well~     as to collect safety data when these two drugs are co-administered. The second part, (Phase~     II), was designed to assess the potential efficacy of the combination in imatinib-resistant~     GIST patients in two strata of patients:~        -  Patients resistant to imatinib as first-line drug therapy and in whom the maximum~          tolerated dose was at least 600 mg/d (Stratum 1, first-line resistant/refractory)~        -  Patients resistant to imatinib as well as to post-imatinib drug therapy (Stratum 2, post~          second-line therapy).~   "
174943|NCT01275209|"~     This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with~     bendamustine in patients with follicular lymphoma.~   "
174944|NCT01275196|"~     The study will compare the efficacy and safety of Nilotinib versus Imatinib in newly~     diagnosed Chinese patients with CML-CP.~   "
174945|NCT01275183|"~     The proposed study is a first-in-human pilot of a novel anti-cancer strategy: Metnase~     inhibition to potentiate DNA damaging chemotherapy. The investigators will conduct serial~     tumor biopsies in subjects with HNSCC at three timepoints: baseline, after cisplatin, and~     after cisplatin-raltegravir. The investigators will investigate immunohistochemical~     expression changes of γH2AX, Chk2, and Annexin V, three biomarkers of DNA damage and~     apoptosis. The study is designed to identify an intermediate signal of the potentiation of~     cisplatin chemotherapy by raltegravir in HNSCC, which will justify a future phase I/II study.~   "
174946|NCT01275170|"~     Part I of this study will compare the pharmacokinetics of MK-7655, dosed in combination with~     PRIMAXIN® (imipenem + cilastatin), in participants with impaired renal function and matched~     control participants. In Part II of the study, the potential for renal insufficiency to~     affect non-renal clearance mechanisms will be investigated.~   "
174947|NCT01275157|"~     This is a single dose study of radiolabeled [14C]-LY2452473 in healthy male volunteers to~     study the absorption, distribution, metabolism, and elimination of LY2452473.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
174948|NCT01275144|"~     The purpose of this study is to determine how much lorazepam gets into the blood and how long~     it takes the body to get rid of it when given together with LY2216684. Information about any~     side effects that may occur will also be collected.~   "
174949|NCT01275131|"~     The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20)~     will change the exposure and action of approved insulin analogs when given by continuous~     subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).~      This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before~     Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage 2.~     Stage 2 was not initiated due to a strategic business decision and termination was not based~     on safety or efficacy concerns. No participants were enrolled in Stage 2.~   "
174950|NCT01275118|"~     Comparison of postoperative visual acuity and spectacle independence between the Tecnis~     Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL~   "
174951|NCT01275105|"~     The purpose of this study is to evaluate the safety, efficacy, and dose response of~     brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of~     allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.~      It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more~     effective than vehicle in the prevention of conjunctival redness induced by conjunctival~     allergen challenge when instilled prior to the allergen challenge.~   "
174952|NCT01275092|"~     The objective of this study is to evaluate the safety and effectiveness of the clinical and~     technical performance of the CorPath® 200 System in the delivery and manipulation of coronary~     guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).~   "
174953|NCT01275079|"~     The purpose of this study is to analyze the change of nasalance after tonsillectomy in Thai~     adults.~   "
174954|NCT01275066|"~     This Phase 3 study will evaluate the efficacy and safety of 2.0 mg/kg/week BMN 110 and 2.0~     mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A~     Syndrome).~      There is currently no standard accepted treatment for MPS IVA other than supportive care.~     Enzyme replacement therapy (ERT) may be a potential new treatment option for MPS IVA~     patients. BMN 110 is administered to MPS IVA patients by IV infusion, allowing cellular~     uptake by the mannose-6-phosphate receptor and transportation to the lysosomes.~      This enzyme uptake into the lysosomes is hypothesized to promote increased catabolism of~     keratan sulfate (KS) in tissue macrophages, hyaline cartilage, other connective tissues, and~     heart valve, and reduce the progressive accumulation of KS which is responsible for the~     clinical manifestations of the disorders.~   "
174984|NCT01274676|"~     Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The~     intra and/or postprocedural cerebral embolization remains the most frequent complication.~     Thanks to the systematic use of cerebral protection systems, these complications have~     reduced.A debate concerning which cerebral protective device should be more effective is~     still ongoing.~   "
174985|NCT01274663|"~     The primary purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.~   "
174955|NCT01275053|"~     The purpose of this research study is to help us to better understand how leptin regulates~     blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells.~     Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and~     influences how the body regulates blood sugar levels. A synthetic form of leptin (A-100), an~     investigational drug and has not yet been approved by the Food and Drug Administration (FDA),~     will be administered to participants in this study. The expected duration of your~     participation is 3 study visits, which will be spread over 3-4 weeks.~      This study involves having fat and muscle biopsies after receiving leptin under local~     anesthesia in the General Clinical Research Center (GCRC), surgical unit, and/or~     Endocrinology exam room at the Beth Israel Deaconess Medical Center.~   "
174956|NCT01275040|"~     A pragmatic cluster randomised controlled trial will be done where the intervention will be a~     mobile screening team visiting selected PHC facilities in Tshwane district. It will provide~     education and screening for diabetic complications (foot, kidney, cardiac and retinal~     complications). Six clinics will receive the intervention and six clinics will serve as~     controls. Six hundred patients will be recruited (2 x 300).~      The screening results will be evaluated by an expert panel at tertiary care level and an~     individualised patient management plan will be compiled. This plan will be communicated to~     the family physician and integration team at the clinic for further management or referral of~     the patients. Laser therapy will be available on the mobile clinic for patients that require~     it (as assessed by an Ophthalmologist who will review the retinal photos).~      A baseline evaluation (including HbA1c, serum creatinine, lipogram and urine~     albumin-creatinine ratio) will be done to determine current disease management at patient and~     health facility level, followed by the intervention and a follow-up visit a year later. The~     main outcome measures are glucose, lipid and blood pressure control as well as the percentage~     of patients screened and referred for diabetes complications.~      A cost effectiveness analysis will be done to estimate the added cost per added complication~     prevented or referred.~      The potential implications for improving diabetes care and preventing long term complications~     are extremely important. The study results will be used to help plan future health care~     services for people with diabetes mellitus in the region.~   "
174957|NCT01275027|"~     The purpose of this clinical research study is to evaluate the effects an investigational~     food product has on the blood sugar and insulin levels in individuals with diabetes.~   "
174958|NCT01275014|"~     The aim is to compare the effectiveness of corticosteroid administration (dexamethasone) with~     a placebo (saline), following arthrocentesis of for the temporomandibular joint (TMJ).~     Twenty-eight participants with TMJ arthralgia, mainly related to osteoarthritis ae randomly~     assigned to two arms of a parallel double blind RCT. In both arms an arthrocentesis procedure~     is carried out, while a single dose intraarticular dexamethasone was delivered to~     participants in one arm. Saline was delivered in the other arm to serve as a control. Follow~     up visits were scheduled after 1, 3 and 24 weeks. During each visit TMJ pain (on a 100mm VAS)~     and joint stiffness (mouth opening in mm) are scored. Generalized estimating equations (GEE)~     are used for statistical analysis.~   "
174959|NCT01275001|"~     The purpose of this research study is to learn more about the effects a musical intervention~     has on typical brain development in preschool-aged children.~   "
174960|NCT01274988|"~     Nucleus accumbens plays important roles in the process of opiate addiction and initial of~     relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its~     activity and thus to effectively prevent the relapse of the opiate dependence.~   "
174961|NCT01274975|"~     This study is designed to assess the safety of intravenous autologous adipose derived~     mesenchymal stem cells transplant in spinal cord injury patients.~   "
174962|NCT01274962|"~     This study is proposed to evaluate whether giving part of the chemotherapy prior to~     radiotherapy and surgery (as opposed to standard of care, which involves giving all the~     chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal~     cancer will result in higher patient compliance to chemotherapy.~   "
174963|NCT01274949|"~     Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED~     patients responding to PDE5i's. This study aimed to determine the capability of LI-ESWT to~     affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor~     therapy.~   "
174964|NCT01274936|"~     Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal~     distribution. Cervical radiculopathy results from impingement on a nerve root by either~     spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation.~     Specifically, it should be the goal of the treating physician to relieve pain, improve~     function, and prevent recurrence. Various studies have shown that nonoperative management of~     cervical radiculopathy leaves a substantial minority of patients with persistently~     troublesome symptoms. Pharmacologic agents treat the underlying condition and provide~     symptomatic relief. The various classes of medications used to treat radiculopathy include~     steroids, nonsteroidal antiinflammatory drugs (NSAIDs), muscle relaxants, narcotics, and~     antidepressants. Herbal medicines have been used for centuries in China. In China, many~     patients with cervical disc disease are increasingly turning to herbal medicines to alleviate~     their symptoms and reduce the side effects of medications. The goal of this study is to~     determine the efficacy and efficacy of an herbal medicine, Qishe Pill, to treat cervical~     radiculopathy.~   "
174965|NCT01274923|"~     This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on~     patients responding to PDE5i therapy in a sham controlled randomized double blind manner.~   "
174966|NCT01274910|"~     This is a single-center, prospective, randomized, double blind, placebo control study. The~     aim of this study is to assess the effect of fish oil capsules on pain intensity and~     postoperative analgesics consumption in patients after knee replacement surgery.~      The study population will be adult are referred for knee replacement surgery due to~     osteoarthritis of the knee.~   "
174967|NCT01274897|"~     This study is designed to evaluate the immunogenicity and the safety of a quadrivalent~     vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.~   "
174968|NCT01274884|"~     Several surgical techniques are used for the treatment of acute acromioclavicular joint~     dislocations. The investigators investigate a new method using arthroscopic repair using the~     Tightrope fixation device.~   "
174969|NCT01274871|"~     Does chest drains contribute to the post thoracotomy pain syndrome~   "
174973|NCT01274819|"~     Rationale: Delirium is a frequently encountered problem in ICU patients and leads to~     increased morbidity and mortality; Delirium in the ICU is associated with sleep deprivation~     which is among others caused by a disrupted circadian rhythm; Dynamic Light application aims~     at restoring a proper circadian rhythm by rhythmically alternating light intensity and has~     shown beneficial effects in sleep quality. Whether DLA improves sleep quality and reduces~     delirium incidence in ICU patients is not known~      Goals/endpoints:~      To evaluate the feasibility of dynamic light application in the ICU and to study the effects~     of dynamic light application on the incidence of delirium, duration of mechanical~     ventilation, the number of ICU and hospital days, and mortality in a mixed population of~     medical and surgical ICU patients. In a subgroup of patients with a high risk of developing~     delirium, markers of circadian rhythm, inflammation and brain damage and post ICU HRQoL will~     be assessed Study design: prospective randomized single centre trial Study population: adult~     ICU patients > 18 years old with an expected duration of stay of more than 24 hours~     Intervention: Patients will be randomized between Standard Care or Standard Care + DLA; When~     receiving standard care, normal lighting settings will be used in that patient room, which~     can be controlled by the medical personnel; In the rooms of patients randomized to the DLA~     group, DL is applied with a changing intensity during the day according to a fixed rhythm,~     which is regulated centrally. In addition when necessary, an intervention light can be used~     which can be operated in the patient room.~      Study parameters/endpoints: incidence of delirium as measured by the CAM-ICU; duration of~     mechanical ventilation, ICU and total hospital mortality; ICU and hospital LOS; Serum levels~     of inflammatory markers and markers of brain damage, urinary levels of markers of circadian~     rhythm, data of HRQoL questionnaires and total light exposure in both groups~   "
174974|NCT01274806|"~     Effectiveness of a physical therapy program focussed on core stability exercise and massage~     as a recovery method in breast cancer survivors after oncology treatment.~   "
174975|NCT01274793|"~     the objective of this study is to investigate the Dose-Effect Relationship of Acupuncture~     with Two-ways Regulation Effect to Treat Functional Enteropathy~   "
174976|NCT01274780|"~     This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized~     to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir /~     emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol~     levels.~      Randomization will be stratified according to the values of the ratio of total~     cholesterol/HDL cholesterol obtained during the screening visit (as they will be <4.5 or ≥~     4.5).~   "
174977|NCT01274767|"~     Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and~     stroke. However, low-dose aspirin increases the risk of ulcer bleeding. Current evidence~     indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events~     and the risk of ulcer bleeding is low (about 1% per year). Since the overall risk of bleeding~     is low, aspirin users who do not have previous ulcer disease do not require prophylaxis with~     anti-ulcer drugs. In contrast, aspirin users with a history of ulcer disease have a 2- to~     4-fold increased risk of ulcer bleeding. The best strategy for reducing the risk of bleeding~     in high-risk aspirin users remains unclear. Current strategies for high-risk patients include~     the use of anti-ulcer drugs, elimination of risk factors (e.g. Helicobacter pylori), or the~     use of enteric-coated aspirin.~      Although co-therapy of aspirin with an acid suppressant reduces the risk of ulcer bleeding,~     drug compliance may limit its clinical usefulness particularly in patients who are already~     receiving multiple drugs. The efficacy of enteric-coated aspirin in preventing ulcer~     complications showed conflicting results. One study found that enteric-coated aspirin~     increases the risk of ulcer bleeding. A recent study showed that enteric-coated aspirin~     causes minimal acute gastric injury.~      The investigators postulated that among patients without H. pylori infection and a history of~     ulcer bleeding who continue to use low-dose aspirin, enteric-coated aspirin reduces the~     long-term risk of ulcer complications to a level that is comparable to that of average-risk~     aspirin users.~   "
174978|NCT01274754|"~     Neurological complications occur in open heart surgery with a frequency of 40% and they range~     from major neurological deficits (due to a stroke) to neurocognitive and behavioral~     disorders. This study aims to determine if erythromycin, a worldwide known antibiotic,~     protects the brain from damage when given in high doses before and during open heart surgery.~      The investigators consume that high dose of erythromycin will protect the brain with a~     pharmacological preconditioning against the global ischemia during the perioperative period~     of heart surgery.~   "
174979|NCT01274741|"~     The purpose of this study is to determine if an integrated, cognitive-behavioral model of~     psychotherapy is effective in the treatment of individuals with posttraumatic stress disorder~     (PTSD) and substance use disorder (SUD) compared to a known evidence-based model for~     PTSD/SUD.~   "
174980|NCT01274728|"~     This clinical evaluation will study the feasibility and safety of a CE-marked~     paclitaxel-eluting balloon in primary PCI in patients with a STEMI. Drug eluting balloons~     provide the potential advantage of delivering a anti-proliferative drug, without the~     disadvantage of leaving a coronary stent, in STEMI patients treated with primary PCI.~   "
174981|NCT01274715|"~     The purpose of this study is to determine if behavioral health coaching for rural veterans~     with diabetes and depression will improve self-management behaviors and lead to improvement~     in diabetes care outcomes (e.g., HA1C) and improvement in reported depressive symptoms.~   "
174982|NCT01274702|"~     Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution~     therapy is a software-based approach that has been shown to substantially improve residual~     visual field deficits in patients with pre- and postchiasmatic lesions.~      The primary hypothesis of this randomized, controlled clinical trial is, that visual~     reconstitution therapy is superior to active comparator treatment in improving the visual~     field after optic neuritis.~   "
174983|NCT01274689|"~     The note re-introduces the external lid loading with the help of a lead weight for the~     temporary treatment of lagophthalmos. Although simple and effective, the technique is rarely~     used.Instead of wearing a monoculus, the patient uses an individually tailored lead weight~     (0.8 mm thickness, 1.0 -2.0 g) sticked on the lid, it enables its closure. A spontaneous~     ptosis indicates a too heavy weight. With the M. levator palpebrae intact, lid lifting is~     possible. The effect is gravity dependent, so that the patient has to wear the monoculus at~     night. To minimize the risk of lead intoxication, the surface of the weight is varnished. In~     case of a persistent paresis of the M. orbicularis oculi an internal lid loading can follow.~     A total of 152 lagophthalmos cases have been treated since 1997.All patients could close the~     lid immediately. Almost half of the patients had to re-adjust the weight several times per~     day due to hooded eyelids. The compliance was high, and a partial or complete restoration of~     the function of the M. orbicularis oculi occurred in 60% of the cases. In some subjects, the~     restoration of the M. orbicularis oculi was faster than of the M. orbicularis orbis. The~     external lid loading for the temporary treatment of lagophthalmos is simple and effective.~     Compared to a monoculus, the vision is unimpaired and the aesthetic is more appropriate for~     most patients. The faster restoration of the M. orbicularis oculi hints at a potentially~     facilitatory effect of the weight.~   "
174986|NCT01274650|"~     Patient nutritional needs vary depending on several factors including age, sex, height,~     weight, injury and co-morbidities. Since injury affects energy expenditure in patients, this~     must be taken into account when assessing nutritional requirements. Indirect calorimetry will~     be used to measure energy expenditure of patients with decubitus ulcers of varying degrees.~     The primary objective of this study is to determine the effects of wound volume on metabolic~     rate and compare this to predictive equations used for estimating energy requirements.~   "
174987|NCT01274637|"~     The purpose of this study is to determine if it is feasible to conduct a multi-center~     randomized trial to determine whether a blood thinner, low-molecular-weight-heparin (LMWH),~     is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.~   "
174988|NCT01274624|"~     This is a Phase 1 dose-escalation study with three dose levels to determine the maximum~     tolerated dose of REOLYSIN® combined with FOLFIRI and bevacizumab.~   "
174989|NCT01274611|"~     The purpose of this study is to compare the effectiveness of two methods in the treatment of~     excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections.~     Suction-curettage is a method in which the doctor will insert a suction tool into two small~     incisions in order to suction out the sweat-producing glands. It is similar to liposuction,~     but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where~     the sweat glands are located. This method has been shown in some studies to effectively~     reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA)~     approved drug that in small doses, paralyses muscles. It is most commonly and famously used~     in the treatment of facial wrinkles. However, it has also been approved to treat excessive~     sweating. When injected in areas that sweat excessively, sweating can be significantly~     reduced in that area for months at a time. This study is a pilot study designed to determine~     feasibility of these procedures.~   "
174990|NCT01274598|"~     This is a phase I, open label clinical trial to evaluate the safety of Lactobacillus~     rhamnosus GG (LGG) in elderly subjects. Lactobacilli are part of the normal flora of the~     intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or~     microorganism administered to confer health benefits. Our research is focused on studying~     the possible therapeutic effects of LGG. The study hypotheses are:~        -  LGG administered twice daily will be safe and well tolerated in elderly subjects~        -  LGG will colonize the stool of elderly subjects and will modify the diversity and~          richness of the microbiota in their nasopharyngeal and stool specimens~   "
174991|NCT01274585|"~     The primary objective of this study is to determine whether Percutaneous Tibial Nerve~     Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of~     patients with urinary incontinence, can also be used to treat fecal incontinence.~     Specifically, the primary endpoint of this study is to determine, in a randomized controlled~     patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the~     patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel~     diary after treatment.~      The investigators secondary endpoints will consist of measurements of the impact of PTNS on~     the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity~     Index (FISI) score ), as well as on the patient quality of life factors related to fecal~     incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL)~     scale).~   "
174992|NCT01274572|"~     This study is being conducted to assess and monitor immune response in patients with~     minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be~     receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment~     regimen.~   "
174993|NCT01274559|"~     This is a multicenter, randomized, double-blind, placebo-controlled study in participants~     with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density~     lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER)~     niacin/laropiprant [ERN/LRPT (MK-0524A)] when added to the following ongoing lipid-modifying~     therapy (LMT): simvastatin,~      atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC),~     or any statin co-administered with ezetimibe. The study is based on the hypothesis that~     ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.~   "
174994|NCT01274546|"~     The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data~     on patients who received the cruciate-retaining Foundation Knee system during or prior to the~     year 2000.~   "
174995|NCT01274533|"~     This is a research study for subjects who have been diagnosed with Adult T cell~     Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus~     HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of this~     research study is to evaluate the use of the investigational drug lenalidomide in the~     treatment of Adult T cell Leukemia/Lymphoma.~      Lenalidomide is a drug that alters the immune system and it may also interfere with the~     development of tiny blood vessels that help support tumor growth. Therefore, in theory, it~     may reduce or prevent the growth of cancer cells.~      Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of~     specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for~     patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM~     are cancers of the blood. It is currently being tested in a variety of cancer conditions. In~     this case it is considered experimental.~   "
174996|NCT01274520|"~     This is a study comparing a technique of continuous circulation to the liver as a means of~     preventing liver damage during transportation to the transplant hospital. This new technique~     of Machine Perfusion (MP) will be compared to the standard technique where the liver is~     maintained in a bag of solution on ice without circulation. The investigators will evaluate~     and compare the outcomes of the transplants with the new technique to the standard technique.~     There will be 24 MP patient's in the study. The investigators have previously used this~     technique with success in 20 human liver transplant patients. The investigators think there~     will be a benefit in terms of less damage to and better function of the donor liver which~     will result in faster recovery for the patients. This protective effect may allow us to~     successfully transplant more patients and prevent people from dying while waiting for a liver~     transplant.~   "
174997|NCT01274507|"~     The purpose of this study is to characterize the clinical, physiologic, and molecular~     profiles of healthy participants, participants with mild, moderate, and severe asthma; and~     participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).~   "
174999|NCT01274481|"~     This study will examine the hypothesis that iloprost maintains and improves ventilation~     perfusion matching in patients with pulmonary hypertension and ARDS/ALI as reflected by 1) an~     improved PaO2/FIO2 ratio as calculated from the measured arterial blood gases obtained before~     and after iloprost administration, 2) an improvement in lung compliance, and 3) an~     improvement in the ventilatory equivalents for oxygen and CO2 measured by expired gas~     analysis.~   "
175000|NCT01274468|"~     The aim of this study is to determine if DCAMLK1 can be measured in the endobronchial biopsy~     specimens and bronchial washings from patients with lung cancer.~   "
175001|NCT01274455|"~     Near 85% of patients with pancreatic adenocarcinoma are diagnosed with a locally advanced~     and/or metastatic unresectable tumor. In these patients chemotherapy (such as gemcitabine) is~     given as a palliative therapy. Aim of the present study is to evaluate the feasibility,~     tolerance and antitumor effect of repeated intratumoral injection of a gene therapy product~     (with antitumor and chemo sensitizing effects) combined with gemcitabine in patients with~     unresectable pancreatic carcinoma.~   "
175002|NCT01274442|"~     Patients that may participate in this case-control study underwent dental implant surgery in~     the University Hospital in Ghent in 2004-2007.~      According to one of our recent papers based on this patient group, 34/461 patients lost one~     or more implants. The goal is to invite these 34 patients, to update the anamnesis, to~     perform a brief clinical oral examination and to have a blood sample. The latter is necessary~     to identify relevant genetic polymorphisms of the patient that are associated with implant~     loss. Among the remaining patients that did not lose implants, another 34 'controls' will be~     invited for the same examinations.~   "
175003|NCT01274429|"~     The goal of this study is to produce a new treatment that would benefit adult subjects by~     lowering the risk of anaphylactic reactions (desensitization), and changing the~     peanut-specific immune response in subjects who have peanut allergy (tolerance). This project~     is designed to study the innovative idea that oral immunotherapy (OIT), the ingestion of~     small increasing amounts of food allergen, will desensitize subjects with peanut~     hypersensitivity by regulating their mucosal and systemic immune reactivity and cause~     long-term tolerance.~   "
175004|NCT01274416|"~     The investigators are trying to learn the most effective way to treat an adolescent's eating~     disorder and how best to involve the parents or caregivers in this process.~      Typically, parents and their child are seen together in therapy. However, this can sometimes~     be difficult for both the parents and the adolescent. Both parents and adolescents have~     different concerns and are struggling with different aspects of the eating disorder.~     Therefore, the treatment in this study involves the parents in treatment, but does not have~     therapy sessions with the parents and child together.~      The purpose of this study is to develop this investigational type of treatment (separated~     family treatment), and see what works best for adolescents and their families.~      Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the first~     16 weeks families separate therapy sessions weekly. For the last 8 weeks families meet with~     the therapist bi-weekly. These bi-weekly sessions are conjoint - that is, adolescents and~     parents will meet with the therapist together. This is to help parents and adolescents come~     together as a family to continue to aid the adolescent in the treatment of his/her eating~     disorder.~      The investigators hypothesize that adolescents who receive ASFT will demonstrate improvement~     in eating disorder symptoms and body-mass index, that caregivers who participate in ASFT will~     demonstrate decreased distress and caregiver burden, that increases in psychological~     acceptance will be seen for both adolescents and caregivers post-treatment, and that~     treatment will be viewed as both credible and acceptable to both caregiver and adolescent~   "
175005|NCT01274403|"~     The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus~     meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients~     with multiple myeloma but not eligible for high dose treatment with stem cells support.~   "
175006|NCT01274390|"~     This study is an ancillary (add-on) study to the clinical trial entitled Red Cell Storage~     Duration Study (RECESS), which has clinicaltrials.gov identifier NCT00991341. The RECESS~     study randomizes cardiac surgery patients to receive either red blood cell units stored for~     no more than 10 days, or red blood cell units stored for at least 21 days, if they need any~     red blood cell transfusions during their hospital stay for the surgery.~      This ancillary study is entitled Impact of Blood Storage Duration on Physiologic Measures:~     RECESS Ancillary Physiologic Study (RECAP). The hypothesis of the RECAP study is that there~     will be differences between the two randomized treatment groups in how much the following~     measurements change, from shortly before a red blood cell transfusion to shortly after a red~     blood cell transfusion, and from before surgery to 24 hours after surgery:~        -  Oxygen saturation in the hand~        -  Oxygen saturation in the brain~        -  Blood flow in the small blood vessels under the tongue.~      The RECAP study will also investigate whether changes in the measurements listed above are~     associated with clinical outcomes, including~        -  The Multi-Organ Dysfunction Score~        -  Death from any cause~        -  Major cardiac events~        -  Major pulmonary events~   "
175007|NCT01274377|"~     Human cytomegalovirus (CMV) is a benign infectious agent in the normal host, but in~     immunocompromised individuals, such as recipients of stem cell transplants, this virus is a~     major cause of morbidity and mortality. While pharmacologic agents exist to treat CMV~     disease, these medications have numerous side effects, the most serious of which is~     myelosuppression. The frequency of neutropenia ranges from 41% to 58% in stem cell transplant~     (SCT) patients treated with ganciclovir. Withdrawal of anti-CMV therapy due to these~     complications may result in recurrent disease. The restoration of cellular immunity to CMV is~     necessary in order to prevent viral reactivation, and the generation of cytotoxic T cells~     against CMV early antigens is perhaps the most important part of the host immune response to~     CMV. At day 40 post-transplant, for example, at least 65% of SCT patients are deficient in~     CD8+ T-cell responses to CMV. Previous studies have demonstrated a direct correlation between~     CMV infection in these patients and cytotoxic T lymphocyte (CTL) function, with patients who~     have defects in cellular immunity being at high risk for invasive CMV disease. The median~     time post-transplant for the development of CMV disease is 50 to 60 days, and CMV~     re-activation occurs in 70 to 80% of CMV sero-positive SCT recipients. Without anti-viral~     therapy as many as 50% of these patients will develop CMV disease.~   "
175008|NCT01274364|"~     Quality diabetes care requires a team approach and informed decisions of patients and care~     providers. Several lines of evidence suggests that a protocol-driven care model delivered by~     trained staff with focus on periodic assessments, reinforcement of patient compliance and~     attainment of multiple treatment targets reduces risk of cardio-renal complications and early~     death in type 2 diabetes.~      The investigators hypothesize that the use of state of the art information technology to~     record, manage and analyze the large amount of clinical information generated during various~     consultation visits will improve the effectiveness and efficiency in implementing these care~     protocols through decision support and regular feedback to both patients and care team.~   "
175009|NCT01274351|"~     This study is designed to investigate the molecular and cytogenetic effects and safety~     profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk~     groups of patients and to compare patients with high Socal risk score with patients having~     intermediate and low Socal risk score.~   "
175010|NCT01274338|"~     This randomized phase III trial studies ipilimumab to see how well it works compared to~     high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that~     has been removed by surgery. Monoclonal antibodies, such as ipilimumab, may interfere with~     the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the~     growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known~     whether ipilimumab is more effective than interferon alfa-2b in treating patients with~     melanoma.~   "
175011|NCT01274325|"~     The purpose of this study is to test hypothesis if Sereflo (ICS/LABA) could reduce airway~     inflammation in asthmatic patients in the same as Seretide.~   "
175012|NCT01274312|"~     Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder~     dysfunction. Recently, the concept of a surgically created somato-sensory reflex arch for~     bladder dysfunction in SCI has been introduced. The concept is promising, not just for~     bladder but also for bowel dysfunction. However, well designed studies need to be performed~     before recommending the procedure to a large number of patients worldwide. In this study the~     investigators perform multidisciplinary studies providing necessary information about the~     clinical outcome of the somato-sensory reflex arch in adult SCI patients.~      The hypothesis is as follows:~        1. Somato-sensory reflex arch increases colorectal transport between defecations~        2. Somato-sensory reflex arch improves colorectal emptying at defecation~   "
175013|NCT01274299|"~     Anthropometric data of infants' face will be obtained using special 3D scanners and software.~   "
175014|NCT01274286|"~     Since the first hospital accreditation was implemented in our country in 1978, we have become~     the fifth in the world, the first in Asia that applied the system of hospital accreditation.~     While discussing the development of the hospital accreditation history of Taiwan, different~     concerns have been raised over time.~      The main objective of this study is to scrutinize if there have been any quality improvement~     of healthcare that hospitals delivered since the renewal of hospital accreditation standards.~     Also, in order to provide suggestions to make the hospital accreditation a better one, this~     study firstly endeavors to locate the differences which were brought out by both the old and~     the new hospital accreditation.~      Second, this study will analyze and survey the impacts of accreditation on hospitals'~     performance and healthcare. After finishing the first two steps, this study will then state~     updated improvement suggestions.~      Documentary analysis and meta analysis will be the two major scientific research methods in~     this study. Data will be collected from various resources, such as government agencies,~     private research institution and hospitals around the nation. By collecting raw data broadly~     and deeply, the accountability, therefore, can be ensured.~      Throughout the efforts of identifying differences between the new and old accreditation~     standards, comparing hospitals' scores on performance index and finding evidence of~     performance improvement, we hope this study would provide the most comprehensive and solid~     suggestions to improve our hospital accreditation system.~   "
175015|NCT01274273|"~     The purpose of this study is to determine whether interleukin-2, interferon-alpha in~     combination with bevacizumab are effective in the treatment of metastatic renal cell~     carcinoma (mRCC).~   "
175016|NCT01274260|"~     Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating~     disorders associated with lung inflammation, low oxygen levels and respiratory failure in~     children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these~     estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000~     deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in~     children. In adult patients, use of steroids early in the course of ARDS appears promising.~     There are no published clinical trials examining the use of steroids for the treatment of~     ALI/ARDS in children.~      Hypothesis:~      Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours)~     and longer than 7 days will have improved clinical outcomes as compared to placebo control~     group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly~     increased PaO2/FiO2 ratios.~   "
175017|NCT01274247|"~     Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg~     maternal nipple pain and infant's latching difficulties. The procedure carries minor~     discomfort for the infants. It is not known whether the use of topical benzocaine, a very~     bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will~     measure the duration of crying in infants treated with topical benzocaine to the duration in~     those not treated with the mediation.~   "
175018|NCT01274234|"~     All subjects requiring percutaneous coronary intervention (PCI) and stenting are eligible to~     participate in the study. Restudy coronary angiogram with Optical Coherence Tomography (OCT)~     would be performed between 1 to 5 months at the time of a staged PCI procedure (for remaining~     coronary disease) or as clinically indicated, and then at 9 months. At the time of the~     9-month restudy (a proper time window for drug eluting stent to develop into restenosis~     should it occur), any new disease detected or restenosis will be treated. The reported~     incidence of drug eluting stent restenosis is around 10% in simple lesions and is expected to~     be higher in diabetic patients, long lesions and multi-vessel diseases; a restudy at 9 months~     actually confers better protection to the patients with advanced disease and any restenosis~     can be treated timely. All data on clinical events and progress will be monitored and regular~     follow-ups will be carried out.~   "
175019|NCT01274221|"~     The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo~     in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom~     setting based on the Permanent Product Measure of Performance (PERMP) total score assessed~     across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind crossover~     period.~   "
175020|NCT01274208|"~     Study objectives:~        -  Investigate the anti-HCV response in patients with Gaucher disease(GD)~        -  Define the potential role of high levels of Glucocerebroside in the immune system~      Study hypothesis:~      High levels of Glucocerebroside can be used as a tool in the antiviral treatment of hepatitis~     C by potentiating the immune response of natural killer T cells and dendritic cells~   "
175021|NCT01274195|"~     In this study we plan to improve the outcome of hematopoietic stem cell transplantation by~     using optimal busulfan dose through pharmacokinetic study.~   "
175022|NCT01274182|"~     The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in~     patients with severe rheumatoid arthritis.~   "
175023|NCT01274169|"~     to measure kidney function by measuring blood creatinine and to compare it to the measurment~     of GFR by Nanotechnology~   "
175024|NCT01274156|"~     This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on~     patients responding to PDE5i therapy in a sham controlled randomized double blind manner.~   "
175025|NCT01274143|"~     The Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project) is~     designed to determine whether a personalized telephone plus mailed print cancer risk~     assessment and behavior change counseling intervention is more effective than a targeted~     mailed print intervention in promoting risk appropriate screening in individuals with a~     family history of the disease. The project targets people residing in both rural and urban~     areas, allowing an examination of differential intervention effects with regard to place of~     residence.~   "
175026|NCT01274130|"~     This is the investigatory study to find out metformin's pharmacokinetics, pharmacodynamics~     and drug-drug interactions classifying the group by MATE1 genotype in healthy volunteers. The~     investigators will apply ranitidine and verapamil to the drug interaction study of metformin.~   "
175027|NCT01274117|"~     Arteriovenous fistulas (AVFs) are made by joining a vein to an artery in order to get the~     vein dilated with sufficient blood flow in order to puncture the vein and clear the blood~     from wastes, in patients whose kidneys are destroyed and cannot provide this function. The~     success rate of this procedure varies between 50-80% and depends mainly on the size of the~     vein, with success being higher with larger veins. One of the veins used for an AVF is the~     basilic vein, located at the upper arm. This vein is however deeply located and necessitates~     movement (transposition) during surgery to a less deep and lateral path before it is joined~     to the artery, in order to be used. A single study has shown that surgery performed in two~     parts (one to enlarge the vein and the second one to relocate the enlarged vein under the~     wound, not in a new path) is more successful than doing the procedure altogether.~      The aim of this study is to confirm the findings of the single study mentioned above (one~     versus two stages of basilic vein AVF), with the difference that the vein will be relocated~     outside the main wound, a method that is widely accepted as being better.~   "
175028|NCT01274104|"~     The purpose of this study is to measure the effect vitamin D has in alleviating muscle pain~     or aches that may be caused by taking certain medications for treating high cholesterol.~   "
175029|NCT01274091|"~     Interactions between genes and environment, i.e. our inherited responses to environmental~     changes, may be crucial in the development of the common diseases. The investigators were the~     first to identify PPARG gene as risk gene for type 2 diabetes. The role of the Pro12Ala~     polymorphism in diabetes risk has also been verified in meta-analysis. However, this effect~     on seems to depend on intervention and age. In this study the effects of diets high with~     saturated fatty acids (SAFA) and polyunsaturated fatty acids (PUFA) are compared in subjects~     carrying either Pro12Pro or Ala12Ala genotype of the PPARG gene.~      Aim of the study:~      To test if subjects with Pro12Pro and Ala12Ala genotypes respond differentially to a diet~     supplemented with high saturated (SAFA) or polyunsaturated fat (PUFA).~      Hypotheses:~        1. Specific: Subjects with the Ala12Ala genotype will be more sensitive to dietary~          modification, and therefore respond more favorably to PUFA diet~        2. More general: Dietary instructions individually tailored according to the genotype would~          allow better treatment of obesity and diabetes~   "
175030|NCT01274078|"~     About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4~     weeks of sedentary life style, randomization decides whether they start with exercise or with~     being couch potatoes. All participants are also randomized to also consume 150 g of~     blueberries on exercise days or not. The exercise is constituted of 5 km running 5 days a~     week during the 4 week period. The exercise period and the couch period are started and~     ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk~     factors are measured before and after this run, ie 8 times in total.~   "
175031|NCT01274065|"~     There is no common rule as to how a drug will affect patients. This is due to the effect~     specific DNA sequences of genes have on drug response, by the effect they have on how~     medications are metabolized. The primary objective of this research is to optimize medication~     therapy and to reduce the number of medications used, specifically medications for people~     with developmental disabilities and co-occuring psychiatric illnesses.~   "
175032|NCT01274052|"~     The researchers investigated nineteen pregnant women in third trimester and again postpartum.~     At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like~     peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and~     glucagon.~      The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit~     decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following~     delivery when normal glucose tolerance is reestablished.~   "
175033|NCT01274039|"~     Local therapy for glaucoma is known to induce a conjunctival inflammation. Because of this,~     trabeculectomy is more likely to fail. The investigators exchange the local therapy by~     systemic therapy using acetazolamide and measure the eye pressure using local therapy and~     systemic therapy using acetazolamide. The investigators suspect an elevated eye pressure~     using acetazolamide compared to local therapy. In summary acetazolamide could be a better~     choice in reference to conjunctival inflammation, but a worse choice in reference to~     controlling eye pressure.~   "
175034|NCT01274026|"~     This study seeks to establish evidence:~        1. that physiologic changes, unrelated to effect on the PAH enzyme, occur in PKU patients~          who are treated with Kuvan® therapy,~        2. that these changes may be caused by enhanced neurotransmitter synthesis in the brain or~          an upregulation of gene expression (increasing the ability of genes to produce~          functional enzymes),~        3. and that beneficial changes in behavior and cognition, especially executive functioning~          skills may result.~      The objective of this study is to correlate any change in behavior and executive function~     skills of PKU patients who are non-responsive to sapropterin effect on the PAH enzyme, as~     defined by lowered blood PHE levels, with urine neurotransmitter levels and broad gene~     expression prior to and after sapropterin administration.~      Expected outcomes would include evidence of sapropterin effects on upregulation of enzymes~     other than PAH that control neurotransmitter synthesis, and any resulting correlation with~     behavioral and cognitive changes.~      The investigators hope this study will inform further detailed investigations into the~     biochemical and molecular actions of sapropterin (Kuvan®) that lead to increased~     understanding of possible treatment effects beyond a lowered blood PHE response.~   "
175035|NCT01274013|"~     The objective of this study is to assess the prevalence of vitamin D deficiency in patients~     with chronic Hepatitis C compared to a matched control group of healthy individuals in the~     Sioux Falls area. It is the hypothesis of this study that vitamin D deficiency is more common~     in patients with chronic Hepatitis C compared to the healthy control group.~   "
175036|NCT01274000|"~     A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with~     diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.~   "
175037|NCT01273987|"~     Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of~     uterus could improve neobladder empty after radical cystectomy in female patients with~     bladder cancer compared to present standard neobladder~   "
175038|NCT01273974|"~     The purpose of this study is to determine whether half-dose intradermal influenza vaccine is~     as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.~   "
175039|NCT01273961|"~     The purpose of this pilot research study is to collect information on the safety and~     effectiveness of an experimental device used to treat and improve the appearance of the skin~     by reducing the visibility of wrinkles and by reducing the looseness of skin.~   "
175040|NCT01273948|"~     This will be a randomized, open-label, active-control Phase II pilot trial of bavituximab~     combined with ribavirin for initial treatment of chronic HCV genotype 1 infection. Eligible~     patients with normal coagulation, hematological, and renal function will undergo a~     screening/washout period of up to 28 days, followed by randomization to receive weekly~     bavituximab or PEG-IFN alpha-2a therapy for 12 weeks, both with twice-daily ribavirin.~      The primary endpoint of this study is the proportion of patients who show a greater than or~     equal to 2-log10 IU reduction in plasma HCV RNA level after 12 weeks of treatment (early~     virological response; EVR).~      Secondary endpoints include the proportion of patients with an undetectable HCV RNA level~     after 12 weeks of treatment; the proportion of patients who show a reduction in HCV RNA level~     of greater than or equal to 2 log10 IU after 4 weeks of treatment, viral kinetics for~     individual patients over time, and comprehensive evaluation of the safety and tolerability of~     bavituximab infusion.~   "
175041|NCT01273935|"~     The aim of this study is to evaluate the low-response prevalence of early antiplatelet~     therapy and to test the influence of different aspirin dosages in patients with acute~     ischemic strokes (AIS).~   "
175042|NCT01273922|"~     This randomized, double-blind, placebo-controlled study is a first-in-human Phase 1 study~     using two dose levels of an investigational vaccine directed against S. aureus and Candida.~     The study is designed to evaluate the safety, tolerability and immunogenicity of the~     investigational vaccine, NDV-3~   "
175043|NCT01273909|"~     The goal of this prospective, observational study is to investigate the clinical,~     psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap~     reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for~     the treatment of lymphedema.~      The investigators hypothesize that (1) perforator flap breast reconstruction will result in~     excellent clinical, psychosocial, and patient satisfaction outcomes compared to~     non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is~     associated with less persistent postsurgical pain than other forms of breast reconstruction,~     even after controlling for major cofactors, such as the extent of auxiliary lymph node~     dissection and the use of radiation therapy; (3) perforator flap reconstruction for the~     treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and~     complications of lymphedema.~   "
175044|NCT01273896|"~     The purpose of this study is to find out what effects, good and/or bad, STA-9090 has on the~     patient and their breast cancer.~      STA-9090 is an experimental drug that works by breaking down cancer proteins. When the cancer~     proteins are destroyed, the cancer cells die. STA-9090 is an experimental drug that is not~     yet approved for the treatment of cancer by the United States (FDA) Food and Drug~     Administration . STA-9090 has been tested in cancer patients in other trials and a safe dose~     for this drug has been found. We are now interested to see how active this drug is against~     breast cancer.~   "
175045|NCT01273883|"~     The purpose of this study was to examine any potential benefit in lessening the severity of~     tinnitus (ringing or booming sensation in one or both ears) in subjects supplemented with~     magnesium (532 mg daily).~   "
175046|NCT01273870|"~     The aim of the dialyzer evaluation is to compare performance characteristics and~     haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux~     dialyzers~   "
175071|NCT01273545|"~     This study will use electronic health services databases to describe the usage patterns of~     dapoxetine hydrochloride (PRILIGY) in Germany and Italy with a focus on describing the extent~     and proportion of patients with characteristics suggestive of the use of PRILIGY within,~     versus outside of the intended use population.~   "
175072|NCT01273532|"~     The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503)~     dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in~     healthy Japanese male participants.~   "
175553|NCT01267266|"~     This randomized phase II clinical trial is studying how well saracatinib works in treating~     patients with prostate cancer. Saracatinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
175047|NCT01273857|"~     Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are~     characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac~     output. Infants with the syndrome generally undergo a staged surgical approach in view of an~     ultimate Fontan procedure. Although long-term survival in patients with HLHS and related~     single ventricle physiology has improved markedly with advances in medical and surgical~     therapies, a growing number of infants will ultimately require heart transplantation for~     end-stage heart failure due to several potential disadvantages include a negative effect on~     right ventricular function, arrhythmia, additional volume load via regurgitation from the~     nonvalved shunt, and impaired growth of the pulmonary artery.~      Risk factors for poor outcome of heart transplantation with HLHS and single ventricle~     physiology are older age at transplantation and previous Fontan operation. New strategies are~     needed to improve the underlying transplant risks proper for the Fontan failure patients.~      Emerging evidence suggests that heart-derived stem/progenitor cells can be used to improved~     cardiac function in patients with ischemic heart disease. In this trial, the investigators~     aimed to test the safety and feasibility of intracoronary injection of autologous cardiac~     progenitor cells in patients with HLHS and related single ventricle anomalies and that could~     improve ventricular function at 3 months' follow up.~   "
175048|NCT01273844|"~     To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone)~     followed by autologous hematopoietic stem cell transplantation as an initial treatment in~     patients with newly diagnosed AL.~   "
175049|NCT01273831|"~     The purpose of this study is to determine which drug makes lower intraocular pressure~   "
175050|NCT01273818|"~     Aim of this study is to measure the effectiveness of topical gentamicin to prevent~     post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is,~     if it is effective as a prophylactic agent, to compare it's effect with intra venous single~     dose cefazolin sodium prophylaxis.~   "
175051|NCT01273805|"~     Hydroxychloroquine is approved for the treatment of non-cancerous illnesses such as~     rheumatoid arthritis and systemic lupus erythematous. Researchers in the laboratory have~     tested tumors from patients with pancreatic cancer and have discovered that they have certain~     pathways inside the cells that promote growth and survival of the tumor. Hydroxychloroquine~     may inactivate these pathways and results in the death of pancreatic cancer cells.~   "
175052|NCT01273792|"~     Susac Syndrome is a rare disease and the establishment of the diagnosis is often difficult.~     The aim of this investigation is to identify relevant biomarkers and to elucidate the~     pathogenesis of Susac syndrome~   "
175053|NCT01273779|"~     Study will evaluate the safety and potential benefit of talactoferrin (recombinant human~     lactoferrin) as an addition to the standard care for severe sepsis.~   "
175054|NCT01273766|"~     RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions.~      PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood~     transfusions in patients with hematologic malignancies.~   "
175055|NCT01273753|"~     The purpose of this study is to examine the impact of exercise during dialysis using~     objective measures of fluid status determination, specifically bioimpedance analysis (BIA)~     and blood volume monitoring (BVM). We hypothesize that exercise during dialysis will be~     associated with more stable blood pressures and that this will be reflected in different~     output from BIA and BVM monitoring.~   "
175056|NCT01273740|"~     Randomized study to evaluate the effect of adding external support to PTFE-grafts used for~     bypass to below knee arteries in patients with critical limb ischemia with respect to primary~     patency, secondary patency, and limb salvage.~   "
175057|NCT01273727|"~     An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of~     vision and lead to swelling, or macular edema. Despite surgery to remove the scar~     tissue(membrane peeling), residual swelling of the retina may continue to interfere with~     vision.~      In this study the investigators will inject an implantable steroid device into the back,~     fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the~     retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by~     the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system~     in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration~     (FDA) for decreasing swelling due to another condition in the eye. This study will help to~     find out whether or not this device Ozurdex™ is also effective for reducing the swelling of~     the retina in patients who have already had surgery to remove scar tissue on the retina.~   "
175058|NCT01273714|"~     The extent of thyroid resection in benign goiter is controversial. Potential advantages of TT~     over BST may include: one-stage removal of incidental thyroid cancer reported in up to 10% of~     operatively treated benign thyroid diseases, and lower risk for goiter recurrence. However,~     these potential advantages should outweigh the risk of morbidity associated with more radical~     thyroid resection.~      The aim of this study was to compare outcomes of bilateral subtotal (BST) vs. total~     thyroidectomy (TT) for benign bilateral thyroid disease.~   "
175059|NCT01273701|"~     The hospital where this study will be conducted is responsible for the one-year contingency~     management treatment for methamphetamine drug offenders referred from the Yunlin District~     Prosecutors Office. Completing the one-year treatment is prerequisite for offenders to get~     slow prosecutions.~      It is an open-label, parallel-group trial comparing the combination of psychosocial~     intervention and slow prosecutions with psychosocial intervention alone in treating subjects~     with methamphetamine dependence~      Study Hypothesis~        1. Psychosocial interventions in combination with slow prosecutions is more effective than~          psychosocial interventions alone to achieve abstinence for subjects with methamphetamine~          abuse/dependance.~        2. Inclusion of telephone reminding before each visit will enhance the retention rate and~          abstinence rate.~   "
175060|NCT01273688|"~     Lateral epicondylitis is a painful overuse condition also described as lateral elbow~     tendinopathy. As at the Achilles tendon or the patella tendon, lateral elbow tendinopathy has~     striking clinically and histologically similarities. As such, neovascularisation closely~     related to pain-mediating fibers are encountered. Eccentric painful exercise is of clinical~     use in Achilles and patella tendinopathy. We sought to evaluate the clinical effect of a~     painful eccentric training (supination and pronation) with or without a orthopedic elbow~     brace in lateral epicondylitis.~   "
175061|NCT01273675|"~     It is well understood that hypertension, dyslipidemia, and diabetes mellitus are the major~     risks of chronic kidney disease. Current guidelines recommend screening kidney estimated~     glomerular filtration function with serum creatinine. But it is not the utmost effective~     method and the GFR would be underestimated. Since good correlation was noticed between serum~     creatinine and chronic kidney disease, urinary microalbumin levels is better for patients~     with risks of chronic kidney diseases. With adequate and early education, or antihypertensive~     agents with angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor~     blockers (ARB), all could alleviate renal function deterioration and the severity of~     proteinuria. As a result, high sensitive methods is urgent and needed for early screening and~     diseases following up under medication with ACEi and ARB in chronic kidney disease patients.~     In this project, the investigators are going to include the patients with typy II diabetes~     mellitus combining with hypertension who are treated with antihypertensive agents. Such~     volunteers will be treated with Candesartan 8-16mg/ day and maintain systolic blood pressure~     <130 mm/Hg, diastolic blood pressure < 80 mm/ Hg as the goal. Therefore, this project would~     make effort on correlation with urinary microalbumin and other biomarkers changes under~     Candesartan treatment- one of ARB medication for 12 weeks, and further exploration of new~     biomarkers that may be related to renal parenchymal injuries.~   "
175062|NCT01273662|"~     This is a phase II study of axitinib as the second-line on the treatment of advanced~     hepatocellular carcinoma (HCC).~      The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor~     effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks~     without progression of tumor-related symptoms.~   "
175063|NCT01273649|"~     Anterior cruciate ligament(ACL) injury is one of the most common sport injuries. The major~     problem after ACL reconstruction or rehabilitation program is quadriceps weakness. Previous~     studies suggested that cryotherapy and transcutaneous electrical nerve stimulation(TENS) can~     effectively reduce the arthrogenic muscle inhibition caused by experimental swelling.~      Objective:~      To exam the effects of 12 weeks cryotherapy and TENS on arthrogenic muscle inhibition in~     subjects with ACL reconstruction.~      Design:~      Prospective study.~      Subjects:~      Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an~     ACL reconstruction surgery.~      Methods:~      Quadriceps activation level, quadriceps peak torque during maximal voluntary contraction and~     rate of force development are measure at presurgery, 3-month, 6-month after surgery. After~     surgery, subjects will receive 12 weeks, 3 days/week, training programs included 20 minutes~     cryotherapy and exercise training with TENS.~      Data analysis:~      Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL). One-way ANOVA will~     be used to analysis data.~   "
175064|NCT01273636|"~     Objective: To examine the risk factors for coexisting endometrial carcinoma in patients with~     endometrial hyperplasia.~      Method: Seventy-seven patients who received hysterectomy for endometrial hyperplasia were~     enrolled and divided into the non-endometrial carcinoma group (57) and the endometrial~     carcinoma group (20) depending on the final pathology. Clinical variables were analyzed.~   "
175065|NCT01273623|"~     To investigate the treatment effects with the Jetstream G3 System in moderate to severely~     calcified peripheral artery disease in the common femoral, superficial femoral or popliteal~     arteries using intravascular ultrasound (IVUS).~   "
175066|NCT01273610|"~     This phase II trial studies the side effects and how well lapatinib ditosylate and~     trastuzumab work in treating older patients with human epidermal growth factor receptor 2~     (HER2)-positive breast cancer that has spread from where it started to nearby tissue or lymph~     nodes (locally advanced) or to other parts of the body (metastatic). Lapatinib ditosylate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some~     block the ability of tumor to grow and spread. Others find tumor cells and help kill them or~     tumor cancer-killing substances to them. Giving lapatinib ditosylate together with~     trastuzumab may kill more tumor cells.~   "
175067|NCT01273597|"~     This observational study will evaluate the clinical benefit of Zemplar (paricalcitol~     injection) in daily routine practice in end-stage renal disease patients with severe~     over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will~     be collected from participants initiated on Zemplar therapy according to standard of care.~     The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the~     proportion of participants achieving target parathyroid hormone levels, and prevalence of~     elevated serum calcium and phosphate levels will be evaluated.~   "
175068|NCT01273584|"~     Obesity is on the rise in all developed countries. Of particular concern is that more young~     people including children are being recognised as being overweight or obese. We know from a~     recent large national enquiry into all maternal and child deaths in the UK, known as CEMACH,~     that obesity is a major risk both for the mother and her child. When all deaths in women~     during pregnancy are analysed, obesity comes out as the most common risk factor. Babies of~     obese mothers are more than 3 times as likely to need admission to the Neonatal Intensive~     Care Unit.~      Traditionally, obesity is treated by lifestyle measures encouraging healthy eating and~     increasing physical activity. Unfortunately these measures are often insufficient to produce~     significant improvements in weight. If obese women gain little or even no weight during~     pregnancy, the outcome of the pregnancy is known to be improved. This was shown in a very~     large study of more than 120, 000 obese women.~      The drug metformin has been used for years in the treatment of diabetes and more recently for~     polycystic ovary syndrome (PCOS). Studies in pregnant PCOS women and women with diabetes in~     pregnancy have shown it to be safe and effective. Fortunately it is relatively cheap and~     taken as a tablet with meals.~      Metformin has the great advantage of not causing weight gain and often leads to a small~     amount of weight loss. It works by improving the body's sensitivity to insulin which is~     important as resistance to insulin is common in obesity.~      We have a lot of experience using metformin to treat women with diabetes in pregnancy where~     it is greatly beneficial. We now wish to examine its potential for obese women who do not~     have diabetes. We are hoping to show that it will benefit these women by causing less weight~     gain, less high blood pressure, and less diabetes. We anticipate babies will also have better~     birth weights, will be easier to deliver naturally, will not need to go to special care baby~     units and will be healthier.~   "
175069|NCT01273571|"~     The purpose of the study is to investigate the potential interaction between multiple oral~     doses of canagliflozin and a single oral dose of metformin in healthy adult volunteers.~   "
175070|NCT01273558|"~     The purpose of this study is to compare the results from two methods used to determine the~     renal threshold for glucose excretion (defined as the lowest plasma glucose concentration at~     which appreciable amounts of glucose appear in the urine) in untreated patients with type 2~     diabetes mellitus and in patients with type 2 diabetes mellitus who are treated with 100 mg~     once-daily canigliflozin for 8 days.~   "
175073|NCT01273519|"~     The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain~     medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and~     ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a~     contraindication for adalimumab as stated in the released summary of product characteristics.~     Therefore it shall be evaluated if pain medication which is used in these participants is~     changed, reduced or stopped due to adalimumab treatment.~   "
175074|NCT01273506|"~     The purpose of this study is to evaluate the bioequivalence of a 50-mg tapentadol (CG5503)~     dose administered as two 25-mg ER, TRF tablets relative to one 50-mg ER TRF tablet in healthy~     Japanese male participants.~   "
175075|NCT01273493|"~     The purpose of this study is to characterize the pharmacokinetics (blood levels) of~     trabectedin after administration to patients with advanced malignancies and hepatic (liver)~     dysfunction.~   "
175076|NCT01273480|"~     The purpose of this study is to evaluate the potential effects of rifampin on blood levels of~     trabectedin after administration to patients with advanced malignancies.~   "
175077|NCT01273467|"~     The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007)~     in patients who have suffered a stroke. The study is not designed to establish efficacy,~     although preliminary explorations will be conducted.~   "
175078|NCT01273454|"~     This study aims to collect clinical information and to examine the usefulness and safety of~     ORal Osmotic System Hydromorphone in Korean cancer patients. The decision to treat patients~     with drug is as per physician discretion and that doses are determined based upon approved~     labeling recommendations and physician discretion.~   "
175079|NCT01273441|"~     Helicobacter pylori is the main cause of chronic gastritis, peptic ulcer and gastric tumors~     (adenocarcinoma and lymphoma). The cure of the H. pylori infection prevents recurrence of~     duodenal and gastric ulcer and improves dyspepsia in a significant proportion of cases, so it~     is cost-effective.~      Eradication therapy has changed over time. The usually recommended pattern in the consensus~     conferences has traditionally been triple therapy, composed by the combination of 2~     antibiotics (clarithromycin plus amoxicillin or metronidazole) and a proton pump inhibitor~     (PPI) for 7-14 days. Recent meta-analyses have that the current global eradication rate after~     standard triple therapy is less than 80%. Several European studies have found even lower~     eradication rates, with 35-40% of cases resulting in treatment failure. Treatment failure~     leads to a second treatment and a new diagnostic test to confirm eradication.~   "
175080|NCT01273428|"~     Testing a drug and a device for the treatment of pressure ulcers, compared with current~     treatments.~   "
175081|NCT01273415|"~     Gene expression studies have identified at least four molecularly distinct subtypes of breast~     cancer including two biologically distinct ER-positive subtypes of breast cancer: luminal A~     and luminal B (with luminal B tumors having poorer outcomes than luminal A tumors). Although~     some luminal B tumors can be identified by their expression of HER2, the major biological~     distinction between luminal A and B is the proliferation signatures, including genes such as~     CCNB1, MKI67, and MYBL2, which have higher expression in luminal B tumors than in luminal A~     tumors. The high cost of gene expression profiling has limited its incorporation into general~     clinical practice. To date, there is no available IHC-based surrogate assay that can~     distinguish between luminal A and luminal B tumors. We hypothesized that the IHC~     determination of the Ki67 index as well as ER, PgR, and HER2 status is able to distinguish~     the luminal B subtype of breast cancers from the luminal A subgroup.~   "
175082|NCT01273402|"~     This study is being done to select an appropriate TF2 bsMAb dose suitable for pretargeting~     the 111In/90Y-labeled hapten-peptide (IMP-288). Eligible patients will receive a fixed dose~     of 90Y-IMP-288 4 days after the TF2 antibody injection. Two different dose levels of TF2 will~     be studied in the first part.~      Once an appropriate TF2 dose is selected based on information learned from the first 2 dose~     levels, patients will be enrolled onto several different increasing dose levels of~     90Y-IMP-288.~   "
175083|NCT01273389|"~     The purpose of this study is to evaluate the efficacy and safety of CNTO 136 administered~     intravenously in patients with active, International Society of Nephrology/Renal Pathology~     Society Class III and IV Lupus Nephritis (LN).~   "
175084|NCT01273376|"~     The purpose of this study is to determine whether RX-10100 are effective in the treatment of~     Major Depressive Disorder (MDD).~   "
175085|NCT01273363|"~     To assess asthma control in Russian patients according to the new criteria provided in the~     international guidelines and identify pharmacological approaches that provide a higher level~     of overall asthma control~   "
175086|NCT01273350|"~     Prospective, non-randomized, single-center cohort study treating internal carotid artery~     stenosis using the Xact Carotid Artery Stent and emboshield distal protection system in~     conjunction with bivalirudin as the procedural anticoagulation~   "
175087|NCT01273337|"~     The purpose of this study is to demonstrate the safety of the delivery of ALD-401 by~     intracarotid infusion and to assess efficacy of treatment in subjects who have had~     unilateral, predominately cortical, ischemic strokes in the middle cerebral artery (MCA).~     ALD-401 is made from the stroke patient's bone marrow and infused 13-19 days after the~     stroke.~   "
175088|NCT01273324|"~     The dual mobility design concept for acetabular liners, as is used in the Restoration ADM~     Acetabular System, has been applied in various implants since its introduction by Gilles~     Bousquet in France in 1976. Dual mobility cups have shown good clinical results and have been~     particularly lauded for low incidence of dislocations. However, the wear performance of this~     design concept has not been proven to date. As wear particles are a possible contributing~     factor in aseptic loosening, the assessment of wear and fixation is an important step in~     proving this implant design.~      The proposed study will combine RSA and peri-prosthetic bone mineral density as well as~     outcome questionnaires to provide a complete in vivo evaluation of prosthesis fixation,~     polyethylene wear, and objective and subjective outcomes for the Restoration ADM Acetabular~     System.~   "
175131|NCT01272765|"~     This is a pilot study to determine the safety and efficacy of an investigational product~     (IHBG-10) on weight change and changes in body composition in subjects who have been taking a~     stable dose of certain anti-psychotic medications for longer than three months.~   "
176174|NCT01259167|"~     The purpose of this study was to assess whether a training program based on Joba® Core~     Trainer is effective in reducing pain and improving physical function and quality of life of~     subjects suffering from Chronic Low Back Pain.~   "
175089|NCT01273311|"~     Background:~      - The Coronary Artery Risk Development in Young Adults (CARDIA) study is an investigation of~     cardiovascular risk factors among African-American and white young adults between 18 and 30~     years of age, first recruited in 1985 86 from Birmingham, AL; Chicago, IL; Minneapolis, MN;~     and Oakland, CA. The study has examined a wide variety of risk factors, including insulin~     resistance, obesity, and diabetes. Based on 20 years of followup, the data provide evidence~     of an increase in the prevalence of many cardiovascular risk factors, as well as other~     factors that may lead to brain disease. To further evaluate these changes, the CARDIA Year 25~     Exam will include a brain imaging component to study brain structure and function in a subset~     of CARDIA participants.~      Objectives:~      - To conduct brain magnetic resonance imaging as part of a 25-year followup study on~     participants in the original CARDIA study of heart disease risk factors in young adults.~      Eligibility:~      - Existing CARDIA study participants in the Minneapolis, MN, and Oakland, CA regions.~      Design:~        -  Participants will be screened with a full medical history and physical examination. -~          Participants will have an MRI scan at the 25-year followup examination for the CARDIA~          study.~        -  No additional testing or treatment will be required for this protocol.~   "
175090|NCT01273298|"~     Patients with chronic obstructive pulmonary disease (COPD) are at greater risk of suffering~     from diseases for which beta-blockers may be indicated and effective. Clinicians remain~     hesitant to administer beta-blockers to COPD patients for fear of adverse effects on lung~     function. However, cardioselective beta-blockers therapy led to a non-significant worsening~     of resting expiratory flow limitation measured by the forced expiratory volume in one second~     (FEV1) as compared to placebo. But, the FEV1 appears to be a crude estimate bronchial~     obstruction in COPD. Importantly, the effects of cardioselective beta-blockers on dynamic~     hyperinflation, a subtle marker of bronchial obstruction, remain unknown. Thus, a prospective~     placebo-controlled study assessing the effects of short-term cardioselective beta-blocker~     therapy on dynamic hyperinflation in patients with moderate-to-severe COPD is needed.~   "
175091|NCT01273285|"~     To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer~     thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and~     to compare these results to conventional Time-Domain-OCT (TD-OCT).~        -  Trial with medical device~   "
175092|NCT01273272|"~     The purpose of this study is to determine whether a comprehensive cognitive-behavioral~     therapy-based, multi-component treatment programme is effective in the treatment of~     neuropsychiatric symptoms of patients with mild Alzheimer's dementia.~   "
175093|NCT01273259|"~     DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic~     hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in~     human. The purpose of this study is to determine if DHEA is effective in the treatment of~     respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease~     (COPD) on exercise capacity and haemodynamic variables. Patients will receive after~     randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation~     concerns clinical parameters, echocardiography and right catheterization after and before~     treatment. Primary end-point is the six-minute walk test. This is a prospective double blind,~     randomised, placebo controlled study which will be realized in four university hospitals in~     France : Bordeaux, Strasbourg, Toulouse and Limoges.~   "
175094|NCT01273246|"~     A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine~     in healthy children (3-11y) and infants (6-35m).~   "
175095|NCT01273233|"~     A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type~     71 Vaccines in healthy adults~   "
175096|NCT01273220|"~     Background:~      - Alcohol use disorders are the most prevalent mental disorders in the United States and are~     a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain~     types of cancer and chronic illness. Research into better treatment methods for alcohol use~     disorders and their associated disabilities requires a broad amount of information on the~     genetic and environmental factors that predispose certain individuals to alcoholism. To~     improve the quality of available information for research, the National Institutes of Health~     is conducting a nationwide survey on alcohol use disorders and related physical and mental~     disabilities, and will collect genetic information through saliva samples.~      Objectives:~      - To collect interview data and saliva samples from the U.S. civilian noninstitutionalized~     population, 18 years and older, in order to study the extent of and contributing factors to~     alcohol use and abuse in the United States.~      Eligibility:~      - Individuals at least 18 years of age who do not live in institutions (i.e., prisons,~     inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and~     the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).~      Design:~        -  The study will involve three main components: an automated computer-assisted interview,~          an automated questionnaire, and the collection of a saliva sample.~        -  Participants will be recruited through community through publically available U.S.~          Census Bureau files.~        -  The interview and questionnaire will ask standardized questions related to personal~          history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and~          eating conditions that frequently co-occur with alcohol and drug use disorders; tobacco,~          medicine and drug use and disorders; selected personality traits, including behavior;~          alcohol, drug, and mental health treatment utilization; and medical conditions related~          to alcohol consumption.~        -  Participants will provide a saliva sample for genetic study.~      Background:~      - Alcohol use disorders are the most prevalent mental disorders in the United States and are~     a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain~     types of cancer and chronic illness. Research into better treatment methods for alcohol use~     disorders and their associated disabilities requires a broad amount of information on the~     genetic and environmental factors that predispose certain individuals to alcoholism. To~     improve the quality of available information for research, the National Institutes of Health~     is conducting a nationwide survey on alcohol use disorders and related physical and mental~     disabilities, and will collect genetic information through saliva samples.~      Objectives:~      - To collect interview data and saliva samples from the U.S. civilian noninstitutionalized~     population, 18 years and older, in order to study the extent of and contributing factors to~     alcohol use and abuse in the United States.~      Eligibility:~      - Individuals at least 18 years of age who do not live in institutions (i.e., prisons,~     inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and~     the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).~      Design:~        -  The study will involve three main components: an automated computer-assisted interview,~          an automated questionnaire, and the collection of a saliva sample.~        -  Participants will be recruited through community through publically available U.S.~          Census Bureau files.~        -  The interview and questionnaire will ask standardized questions related to personal~          history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and~          eating conditions that frequently co-occur with alcohol and drug use disorders; tobacco,~          medicine and drug use and disorders; selected personality traits, including behavior;~          alcohol, drug, and mental health treatment utilization; and medical conditions related~          to alcohol consumption.~        -  Participants will provide a saliva sample for genetic study.~   "
175097|NCT01273207|"~     Bronchiolitis Obliterans (BO) is an obstructive lung disease that can affect individuals that~     have undergone a lung or hematopoietic stem cell transplant. BO has been studied most~     extensively in lung transplant recipients, where it is considered to represent chronic lung~     rejection. It is the leading cause of death after lung transplant, with mortality rates up to~     55 percent. In hematopoietic stem cell transplantation, BO is thought to be a manifestation~     of chronic graft-vs-host disease (GVHD). Up to 45 percent of patients undergoing~     hematopoietic stem cell transplantation at the NHLBI develop a decline in pulmonary function.~     Conventional therapy for patients who develop BO consists of augmentation of systemic~     immunosuppressants. Systemic immunosuppression has limited efficacy for BO and is associated~     with deleterious consequences including increased risk of infections and decreased~     graft-versus tumor/leukemia effects.~      Recently, cyclosporine inhalation solution (CIS) in solution with propylene glycol has been~     shown to improve overall survival and chronic rejection-free survival in lung transplant~     patients. These findings suggest targeted delivery of immunosuppressive therapy to the~     diseased organ warrants further investigation as this may minimize the morbidity associated~     with systemic immunosuppression. However, there currently exists limited data regarding the~     overall efficacy of inhaled cyclosporine to treat established BO following lung~     transplantation. Furthermore, inhaled cyclosporine has not been studied in the treatment of~     BO following hematopoietic stem cell transplantation.~      Here, we propose to evaluate the long-term safety and efficacy, of inhaled CIS for the~     treatment of BO. Enrollment will be offered to subjects who have completed the end of study~     (week 18 visit) for the initial protocol (Phase II Trial of CIS in lung transplant and~     hematopoietic stem cell transplant recipients for treatment of Bronchiolitis Obliterans) and~     who have shown evidence of benefit (either an improvement or stabilization) in BO/BOS with~     CIS treatment.~      Clinical parameters, including pulmonary function tests, will be measured in addition to~     laboratory markers of the anti-inflammatory response to CIS. Adverse events associated with~     extended treatment with CIS will be recorded.~      The primary objective is to provide long-term safety and efficacy data for the use of CIS in~     hematopoietic transplant patients and lung transplant patients with established BO.~      Secondary objectives include investigation of the inflammatory pathways that lead to chronic~     BO and ascertainment of the long term anti-inflammatory effects of this CSA preparation ex~     vivo and in vivo.~      Primary endpoint is the efficacy of extended use CIS for BO/BOS. Secondary endpoints include~     the toxicity profile (adverse events), improvement in high resolution chest CT images,~     results of peripheral blood and bronchoalveolar cytokine arrays to assess secondary markers~     of inflammation, and functional capacity measurements using a six-minute walk test.~   "
175098|NCT01273194|"~     Background:~      - Palliative care, also known as comfort care, is intended to keep a patient comfortable by~     focusing on pain and symptom management to improve quality of life. Although palliative care~     has been demonstrated to be beneficial, it is underutilized in children who have been~     diagnosed with cancer, because current trends favor palliative care primarily at the end of~     life and in only a small number of patients. Children with cancer likely would benefit from~     the incorporation of palliative care from the time of diagnosis, but both doctors and~     families are often reluctant to include it for a variety of reasons. Researchers are~     interested in understanding these reasons to determine better ways to include palliative care~     as part of cancer treatment methods in children with cancer.~      Objectives:~      - To collect information on pediatric oncology patients and their parents attitudes towards~     palliative care, along with cancer treatment, from the time of diagnosis.~      Eligibility:~        -  Children and adolescents between 10 and 17 years of age who have been diagnosed with~          cancer in the past year.~        -  Parents of eligible children.~      Design:~        -  Participants will complete a 30-minute survey about experiences with pain, symptom~          management, and focus on quality of life in the first month following cancer diagnosis.~          Child participants will be asked about their views on the importance of quality of life~          in the beginning of their illness, as well as their attitudes toward symptom-oriented~          care. Parent participants will be asked questions about their child s illness, which~          includes understanding, discussion, and impact of illness.~        -  Treatment will not be provided as part of this protocol.~   "
175099|NCT01273181|"~     Background:~      - MAGE-A3/12 is a type of protein commonly found on certain types of cancer cells,~     particularly in metastatic cancer. Researchers have developed a process to take lymphocytes~     (white blood cells) from cancer patients, modify them in the laboratory to target cancer~     cells that contain MAGE-A3/12, and return them to the patient to help attack and kill the~     cancer cells. These modified white blood cells are an experimental treatment, but researchers~     are interested in determining their safety and effectiveness as a possible treatment for~     cancers that involve MAGE-A3/12.~      Objectives:~      - To evaluate the safety and effectiveness of anti-MAGE-A3/12 lymphocytes as a treatment for~     metastatic cancers that have not responded to standard treatment.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma,~     renal cell cancer, or another type of metastatic cancer that has not responded to standard~     treatment.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests, tumor samples, and imaging studies.~        -  Participants will have leukapheresis to collect enough white blood cells for~          modification in the laboratory.~        -  Seven days before the start of anti-MAGE-A3/12 treatment, participants will have~          chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in~          preparation for the treatment.~        -  After the last dose of chemotherapy, participants will receive the anti-MAGE-A3/12 cells~          as an infusion for 20 to 30 minutes, followed by a dose of interleukin-2 to keep the~          anti-MAGE-A3/12 cells alive and active as long as possible. Participants will also~          receive filgrastim to encourage the production of blood cells.~        -  Participants will remain in the hospital to be monitored for possible side effects, and~          after release from the hospital will have regular followup exams with blood samples and~          imaging studies to evaluate the effectiveness of the treatment....~   "
175100|NCT01273168|"~     Background:~        -  Some types of cancer cells that have hormone receptors on their surfaces need the~          hormone estrogen to grow. The drug tamoxifen blocks estrogen from binding to the tumor~          cells, which helps to slow or stop the growth of cancer. Tamoxifen has been approved for~          treatment of certain types of estrogen-linked cancers, such as breast and ovarian~          cancer.~        -  The experimental drug Z-Endoxifen HCl (endoxifen) is related to tamoxifen, and has been~          shown to work against similar estrogen-linked cancers. In many cancer patients,~          tamoxifen is turned into endoxifen by enzymes in the liver; however, not all people have~          the liver enzymes that can turn tamoxifen into endoxifen, which means that the drug~          cannot work properly. Taking certain other drugs at the same time as tamoxifen can also~          keep it from turning into endoxifen. Researchers are interested in determining whether~          endoxifen tablets are effective in slowing or stopping tumor growth in individuals whose~          hormone-linked tumors have not responded to standard treatment.~      Objectives:~      - To test the safety and effectiveness of daily endoxifen in individuals with hormone~     receptor positive solid tumors that have not responded to standard treatment.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with hormone receptor positive~     solid tumors (breast or other tumors), desmoid tumors, or gynecologic tumors that have not~     responded to standard treatment.~      Individuals with breast cancer must have had at least one prior chemotherapy regimen and one~     prior hormonal regimen for metastatic disease.~      Design:~        -  Participants will be screened with a full medical history (including prior hormone use)~          and physical examination, as well as blood and urine tests, tumor imaging studies, and~          an eye examination.~        -  Participants will take endoxifen tablets daily for 28-day cycles of treatment, and will~          be asked to keep a medication diary to record any side effects.~        -  Participants will have regular clinic visits with blood and urine samples and imaging~          studies to evaluate the cancer's response to treatment.~        -  Participants will continue to take endoxifen for as long as the cancer responds to the~          treatment.~   "
175101|NCT01273155|"~     Background:~      - Belinostat is an experimental cancer treatment drug that works by helping to turn on genes~     that limit cell growth and survival of the tumor that are switched off in cancer cells.~     Belinostat has been given to patients with different types of cancer to measure its safety~     and effectiveness, but it has not been given in a formal trial to cancer patients who have~     abnormal liver function. Because belinostat is processed by the liver, its safety and~     effectiveness needs to be established in individuals who have abnormal liver function.~     Researchers are interested in comparing the effects of belinostat as a cancer treatment drug~     in individuals with normal and abnormal liver function.~      Objectives:~        -  To test the safety and effectiveness of belinostat in individuals who have solid tumors~          and lymphomas and who also have abnormal liver function.~        -  To compare the results of belinostat treatment in individuals with normal and abnormal~          liver function.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with solid tumors or~          lymphomas that have not responded to standard treatment.~        -  Individuals with normal liver function and varying degrees of abnormal liver function~          (mild, moderate, severe) are eligible.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests, and tumor imaging studies. Participants will then be~          divided into study groups based on their liver function.~        -  Participants will receive belinostat in cycles of treatment. Except for cycle 1, all~          cycles will last 21 days. Cycle 1 will last 28 days. For cycle 1 only, participants will~          receive a single dose of belinostat 1 week before the regular 21-day treatment cycle~          starts.~        -  In each cycle, participants will receive belinostat once a day for 5 days, and will be~          asked to keep a medication diary to record any side effects.~        -  Participants will have regular clinic visits with blood and urine samples and imaging~          studies to evaluate the cancer s response to treatment.~        -  Participants may continue to take belinostat for as long as the cancer responds to the~          treatment....~   "
175102|NCT01273142|"~     The purpose of this study is to demonstrate the difference in frequency and level of liver~     function disturbance between patients on efavirenz based ART, and patients on nevirapine~     based ART in HBV and HCV co-infected patients, (and/or with patients with abnormal liver~     function prior to ART), in China. Liver function tests will be measured at baseline and~     follow-up.~   "
175109|NCT01273051|"~     In the Netherlands approximately 2300 new patients are diagnosed with rectal cancer each~     year. Standard treatment for patients with a T2 or T3 rectal cancer consists of preoperative~     short course of radiotherapy followed by surgery. In advanced cases long course of~     radiotherapy combined with chemotherapy is used instead of a short cause. In some of these~     advanced cases a complete remission is observed after a long course of radio-/chemotherapy.~     Patients who respond well to neo-adjuvant treatment carry a better prognosis.~      Objective of this research is to evaluate whether neo-adjuvant chemo-/radiotherapy in small~     non-advanced rectal cancers can be used to obtain a complete or near complete remission. In~     these patients could a complete resection of the rectum as an organ be avoided by treating~     them with a local excision with the TEM-technique (Transanal Endoscopic Microsurgery) of the~     scar. The advantage for these patients is, that they do not need major abdominal surgery and~     in a substantial number of these patients the rectum can be preserved with a better function~     of continence.~   "
175110|NCT01273038|"~     The aim of the current clinical investigation is to evaluate a new filter.~   "
175111|NCT01273025|"~     The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in~     Thai healthy men.~   "
175103|NCT01273129|"~     Background:~      - Medically intractable epilepsy is the term used to describe epilepsy that cannot be~     controlled by medication. Many people whose seizures do not respond to medication will~     respond to surgical treatment, relieving seizures completely or almost completely in one-half~     to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of~     this treatment are not experimental, but researchers are interested in training more~     neurologists and neurosurgeons in epilepsy surgery and care in order to better understand~     epilepsy and its treatment.~      Objectives:~      - To use surgery as a treatment for medically intractable epilepsy in children and adults.~      Eligibility:~      - Children and adults at least 8 years of age who have simple or complex partial seizures~     (seizures that come from one area of the brain) that have not responded to medication, and~     who are willing to have brain surgery to treat their medically intractable epilepsy.~      Design:~        -  Participants will be screened with a medical history, physical examination, and~          neurological examination. Imaging studies, including magnetic resonance imaging and~          computer-assisted tomography (CT), may also be conducted as part of the screening.~          Participants who do not need surgery or whose epilepsy cannot be treated surgically will~          follow up with a primary care physician or neurologist and will not need to return to~          the National Institutes of Health for this study.~        -  Prior to the surgery, participants will have the following procedures to provide~          information on the correct surgical approach.~        -  Video electroencephalography monitoring to measure brain activity during normal~          activities within a 24-hour period. Three to four 15-minute breaks are allowed within~          this period.~        -  Wada test to evaluate speech, comprehension, and memory centers of the brain, using a~          contrast dye to study the blood vessels of the brain and a short-term anesthetic~          administration procedure to test the effects on areas of speech and memory.~        -  Depth electrodes and/or brain surface electrodes to measure brain activities and~          determine the part of the brain that is responsible for the seizures (seizure focus).~        -  Participants will have a surgical procedure at the site of their seizure focus. Brain~          lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality~          will be either removed or treated in a way that will stop or help prevent the spread of~          seizures without affecting irreplaceable brain functions, such as the ability to speak,~          understand, move, feel, or see.~        -  Participants will return for outpatient visits and brain imaging studies 2 months, 1~          year, and 2 years after surgery.~   "
175104|NCT01273116|"~     The current organization of hospital care for older patients with complex healthcare needs is~     of insufficient quality, safety and efficiency. Frail older patients have a higher risk for~     development of complications and consequently a higher length of hospital stay, a higher risk~     of functional decline, and higher care needs after discharge. As nearly half of the patients~     admitted to Dutch hospitals is over 65 years, it is highly necessary to adapt the~     organization of hospital care to their needs. Besides having introduced the medical specialty~     geriatrics, hospital management has not started to provide hospital wide healthcare tailored~     to frail older patients. Therefore, the purpose of this study is to develop and examine the~     effectiveness of an intervention program for frail older patients admitted to hospital aimed~     at preventing functional decline and other hospital related negative outcomes.~   "
175105|NCT01273103|"~     This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6 healthy~     adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and~     follow-up evaluations. In the treatment phase, after an overnight fast of at least 10 hours,~     each subject will receive a single oral suspension dose of GSK2248761 200mg containing [14C]~     - GSK2248761. Following dosing, serial whole blood, plasma, urine, and fecal samples will be~     collected. Subjects will be required to remain in the unit until the radiocarbon excreted~     falls to less than or equal to 1% of the administered dose for two consecutive 24-hour~     collections in both urine and feces, whichever occurs first. Safety will be assessed by vital~     signs, 12-lead electrocardiogram (ECG), clinical laboratory tests, AE monitoring, and~     physical examinations as indicated.~   "
175106|NCT01273090|"~     RATIONALE: Imetelstat sodium may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I clinical trial is studying the side effects and best dose of imetelstat~     sodium in treating young patients with refractory or recurrent solid tumors or lymphoma.~   "
175107|NCT01273077|"~     Two rotavirus vaccines have been authorized for use in Canada: RotaTeq®, Merck Frost Canada,~     Inc. and Rotarix®, Glaxo Smith Kline (GSK). In contrast to the United States, Australia and~     several other western countries, neither rotavirus vaccine is offered in a publicly funded~     program in Canada. A universal rotavirus immunization program offered to all children has the~     potential to prevent moderate to severe forms of the disease associated with rotavirus, with~     associated decreased disease burden and health care costs. This demonstration project seeks~     to evaluate the effect of the implementation of a universal infant immunization program with~     Rotarix employing two different program delivery models (public health delivery or physician~     office delivery) in comparison to a jurisdiction where routine immunization is not provided.~     Only evaluation of the program will be the subject of this study.~   "
175108|NCT01273064|"~     Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC)~     treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1~     chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies).~      Null-responders are defined as patients who failed to achieve a greater than 2 log drop in~     HCV-RNA (Hepatitis C Ribonucleic acid, also known as viral load) levels after 12 weeks of~     treatment (know as an early virologic response, or EVR) during previous SOC therapy.~      If, during previous SOC treatment, a patient had a less than 2 log decline in HCV-RNA at Week~     12 but greater than 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that~     patient is not a null-responder, and is excluded from study participation. If, during~     previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must~     have been < 2 log decline (and still HCV-RNA positive) in order for the patient to be defined~     as a null-responder.~      Patients will be screened and have up to 4 weeks to qualify for study entry. During this~     screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients~     will undergo centralized, stratified (based on ethnicity), randomization to one of four~     treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will~     last 24, 48, or 60 weeks, based on each patient's response to study treatment. SOC + placebo~     patients who do not show a virologic response after 12 weeks of therapy will be rolled onto~     SOC + 15mg CTS-1027, while maintaining the study blind.~   "
175112|NCT01273012|"~     The purpose of this study is to determine whether the probiotic Infloran is cost-effective in~     treating acute childhood diarrhea.~   "
175113|NCT01272999|"~     Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective~     against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.~     It is expected that the effectiveness of Prevnar 13 against ear infections in children will~     be similar to that observed following Prevnar. Pfizer has committed to conduct a~     postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.~   "
175114|NCT01272986|"~     This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic~     myocardial ischemic and acute coronary syndrome patients.~   "
175116|NCT01272960|"~     In order to determine the timing of LNG-IUS insertion that results in a greater proportion of~     women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial~     of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks~     gestation and greater. At the time of vaginal delivery, women will be randomized to receive~     either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks~     post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to~     confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number~     of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the~     safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms~     experienced by participants. This is a sub-study of the Contraceptive Choice Project, a~     prospective cohort study that aims to improve the use of long-acting contraception by~     removing financial barriers which has already enrolled over 5,000 patients. Association of~     this study with CHOICE offers unique advantages including infrastructure to support subject~     recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS~     devices.~      We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS~     immediately after placenta delivery will have higher rates of LNG-IUS continuation due to~     poor rates of follow up in the interval insertion group. This is likely to be particularly~     noticeable in our patient population, which is largely uninsured with poor access to~     healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping,~     which may be disguised by the post-partum period. Published reports of immediate~     post-placenta insertion focus on expulsion rates and do not report on symptoms and~     satisfaction rates.~   "
175117|NCT01272947|"~     The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied~     four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs~   "
175118|NCT01272934|"~     The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied~     four times a day in subjects with acute ankle sprains under 'in-use' conditions, in~     particular with regard to pain relief.~   "
175119|NCT01272921|"~     The duration of motor block for infragluteal parabiceps sciatic nerve block following total~     knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic~     given.~   "
175120|NCT01272908|"~     This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients~     with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or~     current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera~     1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24~     weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on~     study treatment is 48 weeks.~   "
175121|NCT01272895|"~     All patients who have received GENOUS stent implantation at Queen Mary Hospital for treatment~     of ischemic heart disease are eligible for this study. Those with clinical indications to~     undergo restudy coronary angiogram or staged procedure PCI will be primarily recruited into~     this study.~      Optical coherence tomography (OCT) will be performed early after stent implantation to~     evaluate vascular healing response and neointimal coverage.~   "
175122|NCT01272882|"~     Electrical impedance tomography (EIT) monitoring has been researched as a method to determine~     the spatial impedance distribution in a body cross section, but has yet to become an~     established clinical tool. EIT monitoring gives a dynamic, breath-to-breath measurement of~     both global and regional ventilation. Recently, there has been evidence that EIT monitoring~     has great potential to become a non-invasive bedside tool for assessment of regional lung~     ventilation without documented hazards. Potential applications include any adult patients in~     acute respiratory failure. Data collected from this research may contribute to improved~     patient safety outcomes.~      PURPOSE:~      The purpose of this pilot study is to examine the feasibility of using the EIT monitor in~     intensive care unit (ICU) setting on patients with acute respiratory failure and to compare~     the EIT monitor data to standard of care patient assessments. It is hypothesized that the EIT~     monitor, when applied to adults in acute respiratory failure, will correlate with~     conventional standard of care assessments for these patients.~   "
175123|NCT01272869|"~     The aim of the current clinical investigation is to evaluate a new filter~   "
175124|NCT01272856|"~     The purpose of this study is to test the safety of the study drug abatacept and see what~     effects (good and bad) it has in patients with relapsing polychondritis.~   "
175125|NCT01272843|"~     The carotid arteries are blood vessels in the neck that supply blood to the brain. Carotid~     stenosis disease is defined as a narrowing of these arteries due to the build up of plaque.~     The plaque material can also break off and move into the brain. The resulting blockage of~     blood supply to a portion of the brain is what causes 80% of all strokes. One treatment~     option is to have surgery on the carotid artery and remove the plaque. This procedure is~     called a carotid endarterectomy (CEA). There is evidence that proves CEA reduces the risk of~     stroke. The objective of this research project is to determine who is most likely to benefit~     from CEA surgery.~   "
175126|NCT01272830|"~     This research study is being conducted to determine if taking oral (by mouth in pill form)~     Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and~     improve function of non-infected symptomatic postoperative total joint replacements.~   "
175127|NCT01272817|"~     Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses~     including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative~     syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.~   "
175128|NCT01272804|"~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK),~     and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses~     in patients with type 2 diabetes.~   "
175129|NCT01272791|"~     The primary objective of this study is to compare the overall survival of patients with stage~     IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.~   "
175130|NCT01272778|"~     This placebo-controlled crossover study is intended to measure the effect of four doses of~     lorazepam on brain activity measured by magnetoencephalography (MEG) and~     electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple~     cognition testing on 16 healthy male volunteers. On each of five study days subjects will be~     randomized to receive either 0.2, 0.5, 1.0 or 2.0 mg lorazepam or placebo. Brain activity~     will be measured by MEG and EEG in each subject a total of 4 times each study day: prior to~     medication administration and 2, 4, and 6 hours after medication administration. Blood~     samples to determine medication levels and cognition testing will be performed at~     pre-medication baseline and immediately after each post-medication scan time. Data will be~     analyzed to identify changes in brain activity compared to baseline and placebo~     administration using both standard approaches and the Orasi Synchronous Neural Interaction®~     (SNI) test. This study will test the hypothesis that dose-response changes in brain~     functional activity can be accurately measured by MEG/EEG in healthy volunteer subjects after~     single, acute doses of lorazepam.~   "
175132|NCT01272752|"~     This is a pilot study to determine the safety and efficacy of an investigational product~     (IHBG-10) on weight change and changes in body composition in subjects who have just started~     taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel,~     and/or Zyprexa).~   "
175133|NCT01272739|"~     This is a pilot study to determine the safety and efficacy of an investigational product~     (IHBG-10) on weight loss, and changes in body composition.~   "
175134|NCT01272726|"~     The goal of this research study is to measure what percentage of women who suspect they have~     symptoms of ADHD will go on to be diagnosed with ADHD using accepted practice standards. The~     study will also evaluate the influence education on the genetics of ADHD has on a woman in~     her deciding to receive behavioral health treatment for ADHD.~   "
175135|NCT01272713|"~     - Aim~      The AVOID (Air Verses Oxygen In myocardial infarction) trial is designed to determine if the~     withholding of routine oxygen therapy in patients with acute heart attack leads to reduced~     heart damage compared to the current practice of routine inhaled oxygen for all patients.~      - Background~      There is evidence supporting and refuting the current practice of providing oxygen to all~     patients with acute heart attack. A recent summary of clinical trials suggested that oxygen~     may increase the degree of heart damage during heart attack. It also highlighted that the few~     trials into oxygen therapy were performed before the use of modern medications and procedures~     to treat heart attack and that further studies were urgently needed, using contemporary~     practices.~      - Design~      A total of 334 patients will participate in this randomized controlled trial. Patients in~     this study will receive the best current management and care for their condition. Patients~     will be randomized to routine pre-hospital care with oxygen therapy vs pre-hospital care~     without oxygen therapy. Patients will then receive standard hospital care, aside from~     allocated oxygen or no oxygen therapy. The primary outcome measure of heart damage will be~     investigated using routine blood tests. With additional information gathered from other~     aspects of routine heart care including coronary angiogram, electrocardiograms and~     complications of hospital stay. Patients will be followed up at 6 months to determine any~     longer term effects of treatment.~   "
175136|NCT01272700|"~     Prone position in spinal surgery can increase airway pressure and decrease dynamic lung~     compliance by a frame used for postural stabilization. Also, it can increase hemodynamic~     instability such as reduced blood pressure by aggravating cardiac index.~      Former study shows pressure controlled ventilation on the pulmonary mechanics can improve~     alveolar use and oxygenation than volume controlled ventilation. The latter one means~     controlling a patient's breathing completely through tidal volume and set breathing rate.~     This could be useful for the patients not possible to breath by themselves because it~     guarantees the perfect breathing.~      The pressure controlled ventilation is used when there is a possibility to change a patient's~     environment. The pressure will be maintained steadily, but volume and flux will be changed.~     That means through the pressure already set, the whole breathing will be maintained from the~     beginning to end. If a patient's resistance is increased, the volume will be decreased even~     though the way of blood pressure control is same. However, the tidal volume per minute can be~     controlled somewhat and barotrauma can be decreased by controlling respiratory rate. Through~     this study, we are expecting the pressure controlled ventilation in prone position can~     improve lung mechanics and oxygenation.~   "
175137|NCT01272687|"~     The genotype-phenotype correlation in patients with Parkinson's disease with specific~     mutations in the glucocerebrosidase gene (Gaucher gene) is known from own clinical~     experiences as well as from case reports in the literature. The epidemiological study will~     determine the frequency of heterozygous mutations in the glucocerebrosidase gene and~     correlate to the clinical onset and development by measuring and documenting severity of~     symptoms (e.g. cognitive deficits, L-dopa responsiveness, depression) in clinically~     well-characterized Parkinson's patients.~   "
175138|NCT01272674|"~     Adiponectin and exercise training contribute to the maintenance of a normal vascular tone by~     influencing vascular NO bioavailability and concentration and function of endothelial~     progenitor cells. The molecular mechanisms are only partially understood. Therefore, aim of~     the present study is to elucidate the effects of Adiponectin on endothelial progenitor cell~     migration and the underlying signaling pathways. Furthermore, the impact of exercise training~     on adiponectin-mediated endothelial progenitor cell migration will be investigated.~   "
175139|NCT01272661|"~     Breast for Success is a new direct service program focused on overcoming barriers to~     breastfeeding for low-income inner-city mothers by use of a culturally competent and~     home-based educational and support intervention. Key project components include a new~     Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and~     two innovative support plans, the Breastfeeding Doula and Father Support Programs. The~     objective is to increase breastfeeding rates for high-risk inner-city mothers.~      Research Questions to evaluate project feasibility and effectiveness are:~        1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented?~        2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all~          mothers?~        3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between~          interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?~        4. What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?~   "
175140|NCT01272648|"~     This project will test and evaluate a rehabilitation programme, which will empower the mens~     health and give them resources to face at new everyday life.~      The project examines if a focused interdisciplinary intervention has influence of the~     patients generic and specified quality of life after curative radiotherapy due to prostate~     cancer.~      The intervention contains nursing consultation with information about late side effects, an~     individual plan and counselling in toilet habits, smoking cessation, weight control and~     psychological problems after treatment. Furthermore the patients are having physiotherapy~     with pelvic floor examinations. The nurse can refer to other collaborators.~   "
175141|NCT01272635|"~     This protocol is comprised of two separate, but linked, clinical trials for treating~     preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL)~     will try to prevent wheezing illness from developing using azithromycin. If a wheezing~     illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms~     using oral corticosteroids.~   "
175142|NCT01272622|"~     The present investigation is a prospective, multicenter study evaluating craniopharyngioma~     patients' prognoses following the various currently-practiced therapeutic strategies.Primary~     goals of the study are to establish quality standards and compare the various therapy~     strategies with respect to their effectiveness and impact on the quality of life of treated~     patients. A stratified randomization of two treatment arms will be conducted with respect to~     timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors~     are incompletely resected. The researchers will investigate whether an immediate,~     postoperative irradiation is superior to progression-contingent irradiation based on~     alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month~     post op) to 3 years after randomization. Progression-free survival and overall survival will~     be examined as closely-related subgoals.Postoperative data will be evaluated via a~     surveillance study for all complete resection patients as well as for those patients under 5~     years of age regardless of their resection grade.~   "
175143|NCT01272609|"~     Pulsed dye laser (PDL)is the gold standard treatment of port wine stains (PWS). However, many~     sessions are required and failure or relapses are not uncommon. It has been demonstrated that~     a neoangiogenesis occurs after PDL, explaining at least partially those failure. The~     objective of this study is to evaluate the use of a topical beta-blocker (timolol 1% gel) as~     a combination treatment with PDL for treating PWS.~      Methods. Prospective multicenter study comparing PDL alone to PDL + timolol. Sessions of PDL~     will be performed once a month for 3 months. One group will be treated with PDL alone and the~     other will also applied timolol 1% gel twice a day during treatment. The evaluation will be~     done one month after the third session.~   "
175144|NCT01272596|"~     Impairment of visual deficits, in particular contrast acuity and contrast impairment are~     frequent symptoms in MS. However, visual function is not appropriately covered by the~     standard tools for clinical assessment, namely, the EDSS and the MSFC.~      The primary aim of this study is to investigate, whether in MS patients contrast acuity and~     sensitivity change over a period of two years.~      Secondary aims are the correlation of visual contrast parameters with structural retinal~     changes and quality of life.~   "
175145|NCT01272583|"~     Hypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory~     response to hypoglycaemia, with glucagon as the most important mediator, is initially~     diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus~     increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors augment the~     glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The investigators~     hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will~     recover the alpha cell response to hypoglycaemia.~   "
175146|NCT01272570|"~     The 3 Specific Aims are (1) To determine the prevalence, incidence and severity of oral~     conditions in postmenopausal early stage breast cancer survivors within the first 18 months~     of adjuvant Aromatase Inhibitor(AI) therapy, (2) To determine the oral health quality of life~     among postmenopausal early stage breast cancer survivors who are receiving AI therapy, (3) To~     determine the utilization of dental care among postmenopausal women receiving AIs with a~     history of early stage BCa over time. The hypothesis for this pilot study is that AIs~     negatively impact oral health and oral health quality of life in the setting of breast cancer~     survivors. Further, we hypothesize that dental visits are underutilized in women with BCa~     undergoing adjuvant AI therapy.~   "
175147|NCT01272557|"~     This study is a prospective, randomized, open-label, multicenter phase IIB trial in order to~     determine time to progression of the combination therapy sorafenib plus doxorubicin against~     standard-of-care sorafenib in advanced HCC not amenable to non-systemic treatment.~   "
175148|NCT01272544|"~     The aim of this longitudinal study was to assess the oral health of individuals attending a~     mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the~     control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the~     individuals who attended the PPPWB had better oral health status than the control group. When~     the two phases of the study were compared, it was noted that the individuals in the second~     phase had better oral health, although they had a higher score for gingival bleeding.~   "
175149|NCT01272531|"~     This is a prospective pharmacogenomics study of mood stabilizer response. The goal of this~     work is to identify genes associated with good response of patients with bipolar disorder to~     two commonly used mood stabilizing agents, lithium and valproate.~   "
175150|NCT01272518|"~     The purpose of this study is to characterize the behavior of cardiac patients with Mood~     Disorders and its clinical course, interpreting the results from a theoretical framework of~     Chaos Theory and Complexity Theory and Systems as well.~   "
175151|NCT01272505|"~     Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some~     obstacles making this procedure more complex than conventional laparoscopic cholecystectomy.~     The use of harmonic scalpel may aid in solving some of these issues that may allow~     simplification of the technique. The investigators will compare the ordinary method of single~     incision laparoscopic cholecystectomy versus harmonic scalpel single incision laparoscopic~     cholecystectomy.~   "
175152|NCT01272492|"~     The investigators are recruiting participants for a randomized controlled trial to evaluate~     the usability and educational value of a nutrition education touchscreen computer program~     targeting Spanish-speaking Latina caregivers of children 2 and under.~      Participants will be randomized to the intervention group - use the computer program and the~     control group - do not use the program. They will be asked basic demographic questions,~     nutrition knowledge questions and computer users will be asked usability questions.~      Objectives are~        1. Evaluate the subjective and objective usability of the touchscreen computer.~        2. Determine whether health knowledge on nutrition topics is enhanced through the use of~          the computer modules.~   "
175153|NCT01272479|"~     The aim of this study is to address questions regarding the link among hepcidin,~     hematological iron markers, inflammation and hepatitis C in HD patients. In attempt to~     address this issue, we planned to measure serum levels of hepcidin prohormone (pro-hepcidin),~     inflammatory and iron parameters.~   "
175166|NCT01272310|"~     The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose~     combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN~     alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who~     failed to respond following a course of PEG-IFN and RBV Therapy.~   "
175154|NCT01272466|"~     Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and~     are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to~     proteasome inhibition present exogene antigens better than unexposed dendritic cells.~     Patients with relapse of multiple myeloma will be offered vaccination with peptides derived~     from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory~     adjuvant. The vaccination will be given in relation to treatment with the proteasome~     inhibitor bortezomib.~   "
175155|NCT01272453|"~     This is a prospective, controlled observational trial of patients undergoing clinically~     indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography~     and coronary CT angiography (CCTA).~   "
175156|NCT01272440|"~     Asparaginase is an important drug i the treatment of childhood leukaemia.~      The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody~     development and hypersensitivity reactions during prolonged PEG-asparaginase treatment.~      Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged~     PEG-asparaginase treatment: A NOPHO ALL-2008 study~      Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study~      Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated~     according to the NOPHO ALL 2008 protocol~      Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing~     interval, adverse effects and EFS, which may lead to improved future therapy~      Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries~   "
175157|NCT01272427|"~     The investigators hypothesize that glucose and whey protein given 30 and 60 min before a~     pizza meal will exert different effects on food intake in adolescent children, and will~     depend on pubertal stage. Food intake will be measured at 30 and 60 min following a~     glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight) or~     sweetened noncaloric beverage. Subjective appetite will be measured as well.~   "
175158|NCT01272414|"~     Currently there are few therapeutic options for the treatment of lid retraction secondary to~     thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable~     of creating a ptosis, that in the setting of TO can return the upper lid to a more~     physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent~     stage lid position. This investigation aims to examine the properties of this relationship.~   "
175159|NCT01272401|"~     The purpose of this study is to determine how physical activity, other lifestyle factors, and~     psychosocial factors are related to quality of life and other health outcomes across the~     breast cancer survival spectrum from diagnosis to long term survival in a nationally~     representative sample of breast cancer patients and survivors across a 6 month period of~     time.~   "
175160|NCT01272388|"~     Currently, aortic stenosis (AS) is considered a surgical disease with no medical therapy~     available to improve any clinical outcomes, including symptoms, time to surgery, or long-term~     survival. Thus far, randomized studies involving statins have not been promising with respect~     to slowing progressive valve stenosis. Beyond the valve, two common consequences of aortic~     stenosis are hypertrophic remodeling of the left ventricle (LV) and pulmonary venous~     hypertension; each of these has been associated with worse heart failure symptoms, increased~     operative mortality, and worse long-term outcomes. Whether altering LV structural~     abnormalities, improving LV function, and/or reducing pulmonary artery pressures with medical~     therapy would improve clinical outcomes in patients with AS has not been tested. Animal~     models of pressure overload have demonstrated that PDE5 inhibition influences NO-cGMP~     signaling in the LV and favorably impacts LV structure and function, but this has not been~     tested in humans with AS. Studies in humans with left-sided heart failure and pulmonary~     venous hypertension have shown that PDE5 inhibition improves functional capacity and quality~     of life, but patients with AS were not included in those studies. The investigators~     hypothesize that PDE5 inhibition with tadalafil will upregulate NO-cGMP signaling, reduce~     oxidative stress, and have a favorable impact on LV structure and function as well as~     pulmonary artery pressures and quality of life. In this pilot study, the investigators~     anticipate that short-term administration of tadalafil to patients with AS will be safe and~     well-tolerated.~   "
175161|NCT01272375|"~     The purpose of this study is to investigate the time course of PF-04764793 concentration in~     the blood following dosing by oral inhalation from dry powder inhalers.~   "
175162|NCT01272362|"~     In this 5-months study, the response of patients to salbutamol at baseline will be compared~     with their response to treatment with indacaterol.~   "
175163|NCT01272349|"~     The goal of the study is to determine whether repeatedly breathing low oxygen levels for~     brief periods (termed intermittent hypoxia) will improve limb function after spinal cord~     injury. This idea stems from animal studies on respiration, in which investigators have shown~     that mild intermittent hypoxia improves breathing in spinally injured rats. These studies~     have shown that intermittent hypoxia induces spinal plasticity, strengthening neural~     connections and motor neuron function within the spinal cord. Exposure to mild intermittent~     hypoxia triggers a cascade of events, including increased production of key proteins and~     increased sensitivity of spinal cord circuitry necessary for improved breathing.~      The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as~     a therapeutic approach to stimulate recovery of limb function in human patients.~   "
175164|NCT01272336|"~     The goal of the study is to examine the effects of repeated breathing episodes of mild~     intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability~     following cervical spinal injury, and to determine whether these changes result in improved~     hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of~     the nervous system to strengthen neural pathways based on new experiences), which could~     result in improvements in hand use for persons with spinal cord injury (SCI).~   "
175165|NCT01272323|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis and/or asthma.~      The purpose of this optional observational follow-on study is to further evaluate~     rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who~     completed all dosing visits in study CP005 approximately one year after the start of~     treatment.~   "
175167|NCT01272297|"~     Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED~     patients responding to PDE5i's. This study aimed to determine the capability of swt to~     convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.~   "
175170|NCT01272258|"~     PRO 140 2102 is a phase 2b, national, multicenter, randomized, double-blind,~     placebo-controlled study in order to evaluate the safety and efficacy of PRO 140 (anti-CCR5~     monoclonal antibody) administered subcutaneously as an adjunct to a new, optimized, oral~     antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented~     poor adherence to the previous antiretroviral regimen.~   "
175171|NCT01272245|"~     The goal of this clinical research study is to learn if omacetaxine given with cytarabine can~     help to control the disease in patients with AML or high-risk MDS. The safety of the study~     drugs will also be studied.~   "
175172|NCT01272232|"~     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).~      The aim of this trial is to investigate the potential of liraglutide to induce and maintain~     weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added~     onto subject's pre-trial background diabetes treatment of either diet and exercise only or~     single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or~     glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration~     of the trial will be 56 weeks followed by a 12 week observational follow-up period.~   "
175173|NCT01272219|"~     This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.~      The aim of this clinical trial is to evaluate the potential of liraglutide to induce and~     maintain weight loss over 56 weeks in obese subjects or overweight subjects with~     co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide~     to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.~      Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either~     68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment~     period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects~     with pre-diabetes status at baseline).~   "
175174|NCT01272206|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety and~     pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011~     compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.~   "
175175|NCT01272193|"~     This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and~     safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with~     type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects~     continued at the same dose and dosing frequency.~   "
175176|NCT01272180|"~     This study will evaluate the safety and immunogenicity of combination vaccines as compared to~     the reference vaccines~   "
175177|NCT01272167|"~     Epidemiological studies definitively show that fruit and vegetable consumption is an~     important factor for the prevention of age-related diseases such as cardiovascular diseases~     (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently~     consumed worldwide, essentially as juices.~      Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely~     flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively~     significant source of a specific flavanone called naringin.~   "
175178|NCT01272154|"~     Purpose~      - Objective : Sensorimotor adaptation allows the modification of the motor command taking~     into account the errors detected during execution of prior movements. It involves a large~     cortico-subcortical network. Isolated lesions of this network do not systematically alter~     sensorimotor adaptation except for cerebellar lesions. The cerebellum is thus a key structure~     for sensorimotor adaptation. However, the link between cerebellar and the cortical plasticity~     underlying sensorimotor adaptation remain unknown. Alteration of sensorimotor adaptation is~     associated with dystonia but it is unclear whether it is a cause or consequence of dystonia.~     It has been hypothesized that the abnormal plasticity observed in dystonia could account for~     the associated alteration of sensorimotor adaptation.~      Classically, basal ganglia dysfunction is considered to be crucial for dystonia pathogenesis.~     However, recent studies suggest that the involvement of the cerebellum may also be important~     in this setting. In primary dystonia, imaging studies showed abnormal cerebellar activation~     during sensorimotor adaptation tasks and neurophysiological studies demonstrated a decrease~     of cerebellar output.~      The aim of this study is to investigate the role of the cerebellum in the cortical plasticity~     underlying sensorimotor adaptation both in healthy subjects (normal plasticity) and in~     dystonic patients (abnormal plasticity).~      - Methods: Paired associative stimulation PAS consists in repetitive pairing of a peripheral~     nerve and a cortical stimulation. This kind of stimulation has been designed to induce~     artificial plasticity that can be easily measured. This PAS induced sensorimotor plasticity~     is exacerbated and has lost its topographical specificity in dystonic patients.TMS using~     trains of TMS pulses (rTMS) can be applied on the cerebellum to modulate its output. We will~     test the effect of rTMS induced modulation (cTBS- inhibitory, iTBS-excitatory, sham) of the~     cerebellar output on PAS induced plasticity in patients with dystonia and healthy control.~      We will also assess the acute effect of the rTMS induced modulation of the cerebellar output~     on the dystonic symptoms and on the performance at a validated sensorimotor adaptation task.~     This will be done by double blind post-hoc scoring of the dystonia (BFM or TWSTRS) on~     standardized videorecording and measurement of the performance at the task after each rTMS~     session (cTBS, iTBS, sham).~      Finally, we will assess the variation of PAS effect on other parameters reflecting cortical~     excitability after each rTMS session (cTBS, iTBS, sham).~   "
175179|NCT01272141|"~     The patient is being asked to join this clinical research study to find out if lapatinib, an~     agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface~     of cancer cells in combination with everolimus, an agent that targets a protein in the cancer~     cell, called mammalian target of rapamycin (mTOR) is effective in metastatic triple negative~     breast cancers that are no longer controlled by standard chemotherapy.~   "
175180|NCT01272128|"~     The primary objective is to assess the quality of life of intramuscular (IM) Interferon~     Beta-1a in participants with relapsing remitting multiple sclerosis (RRMS) or Clinically~     Isolated Syndrome (CIS) in a clinical practice setting.~   "
175181|NCT01272115|"~     Background: Climacteric stage women experience significant biological, psychological and~     social changes. With demographic changes being observed in the growing number of climacteric~     stage women in Mexico, it is important to improve their knowledge about the climacteric stage~     and its potential associated problems, encourage their participation in screening programs,~     and promote the acquisition of healthy lifestyles.~      At Mexican health care institutions the predominant health care model for climacteric stage~     women has a biomedical perspective. Medical doctors provide mostly curative services and have~     limited support from other health professionals. This study aims to design an integrative~     health care model (IHCM: bio-psycho-social, multidisciplinary and women-centered) applicable~     in primary care services aimed at climacteric stage women.~      Methods: A field trial with one intervention and one comparison group, with ex ante and ex~     post measurements will be conducted in two IMSS primary care clinics in Mexico City. The~     clinics will be selected for convenience; each clinic must have more than 20 family doctors'~     offices and available space for the intervention (consulting room and an area for group~     counseling) and should have accepted to participate in the study; The intervention will be~     conducted in one clinic and the other clinic will serve as a comparison group, where the~     usual care for climacteric stage women will be observed.~      The study population will consist of women affiliated with IMSS, between 45 and 59 years of~     age with a maximum of 5 years after menopause. The women should be users of the clinic, and~     should not have mental conditions that would prevent them from understanding the information~     or from taking independent decisions (dementia, mental retardation or psychosis), a physical~     disability that would impede them from participating (hearing loss, diseases affecting~     physical mobility as severe forms of rheumatoid arthritis), medical diagnosis of depression,~     diabetes mellitus, hypertension, renal or liver failure, and/or cancer, because patients with~     these diseases require specific care provided by several specialists. All women must agree to~     participate in the study through written informed consent.~      The IHCM consists of collaborative and coordinated provision of services by a health team,~     which is involves a family doctor, nurse, psychologist, and the woman herself. The health~     team promotes the empowerment of women through individual and group counseling on the~     climacteric stage and health related self-care. The intervention lasts three months followed~     by a three-month follow-up period to evaluate the effectiveness of the model. The~     effectiveness of the model will be evaluated through the following aspects: health-related~     quality of life (HR-QoL), empowerment, self-efficacy and knowledge regarding the climacteric~     stage and health-related self-care activities, use of screening services, and improvement in~     lifestyles (regular leisure time, physical activity and healthy diet).~      The sample size for the primary outcome (HR-QoL) was estimated by using the formula to test~     change in the mean of two normally distributed samples in longitudinal studies. An average~     increase of at least 10 points in one or more domains of WHQ23 in the intervention group~     compared with control group women was considered to be clinically relevant. The assumptions~     included: a mean HR-QoL score of 64.9 points (standard deviation of 23.4 points) in the~     domain of general well-being, a= 0.05 ( for one-sided hypothesis) and ß = 0.20. The number of~     women by group, assuming a drop-out rate of 20% will be 107.~      We also estimated a sample size for regular leisure time physical activity considering that~     this is the outcome variable more difficult to achieve. It was assumed that only 17% of women~     in Mexico engaged in some type of regular leisure time physical activity and a positive~     increase of at least 10% will be achieved after women participation in the IHCM. For this~     calculation, we used the formula to test the difference of proportions between two~     populations with a= 0.05 (one side) and the power of 80%. The total number of women by group~     to include assuming a drop-out rate of 20% will be 207.~      Discussion: Participation in preventive activities should be encouraged among women in~     Mexico. Designing and evaluating the effectiveness of an integrative health care model for~     women at the climacteric stage, based on the empowerment approach and focus on health-related~     self-care to improve their HR-QoL is pertinent for current health conditions of this age~     group.~   "
175182|NCT01272102|"~     To determine the area under the Receiver Operator Characteristic Curve (AUC) for the Ganglion~     Cell Analysis (GCA) average thickness.~   "
175183|NCT01272089|"~     The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed~     once-daily, in subjects with allergic conjunctivitis and to record any adverse events as~     described by the subjects as a part of this post marketing surveillance study.~   "
175184|NCT01272076|"~     The objective of this study is to compare Cirrus HD-OCT automated measurements of the~     illumination area under the retinal pigment epithelium (RPE) to expert manual measurements of~     areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF)~     images.~   "
175185|NCT01272063|"~     The objective of this study is to compare the areas designated as elevated retinal pigment~     epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus~     photographs (CFPs).~   "
175209|NCT01271751|"~     The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum~     Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels~     compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to~     assess the tolerability and safety of once-a-day administrations of oral doses of GFT505~     during 28 days.~   "
175186|NCT01272050|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known~     which radiation therapy regimen is more effective in treating patients with relapsed prostate~     cancer.~      PURPOSE: This randomized phase III trial is studying the side effects of radiation therapy~     and comparing two radiation therapy regimens in treating patients with relapsed prostate~     cancer after surgery.~   "
175187|NCT01272037|"~     This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole,~     letrozole, or exemestane with or without chemotherapy work in treating patients with breast~     cancer that has spread from where it began in the breast to surrounding normal tissue~     (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using~     tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor~     cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast~     cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether giving~     tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination~     chemotherapy in treating patients with breast cancer.~   "
175188|NCT01272024|"~     1.) To integrate discharge planning into an intervention provided by advanced practice nurses~     (APRNs)for patients with advanced cancer, 2.) To evaluate the effects of the intervention,~     and 3.) To explore the reach, adoption, and implementation of the intervention to facilitate~     the transition of patients from surgery/biopsy/chemotherapy to medical oncology in a~     comprehensive cancer center.~   "
175189|NCT01272011|"~     Change to Reflect What Was Done and reason Changes Were Made.~      The purpose of this study is to determine (1) if a specific breathing treatment (intermittent~     hypoxia) can promote changes in breathing function and (2) if pairing breathing treatments~     (hypoxia) with locomotor training can enhance the benefits of walking recovery observed with~     locomotor training alone (without breathing treatments).~   "
175190|NCT01271998|"~     The primary purpose of this study is to determine the steady-state plasma pharmacokinetics~     (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar~     macrophages (AM) of healthy volunteers.~   "
175191|NCT01271985|"~     The purpose of this study is to determine the effects of PolyPill tablet (a fixed dose~     combination of two anti-hypertensive medications, atorvastatin and aspirin) on primary and~     secondary prevention of cardiovascular disease in Iranian adults older than 50.~   "
175192|NCT01271972|"~     This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/~     SAR307746) administered IV every 2 weeks.~   "
175193|NCT01271959|"~     The purpose of this research study is to collect information from patient's medical records~     that had a test called ChemoFx® ordered and to understand how doctors may have used the~     results of the ChemoFx® to treat patients with cancer.~   "
175194|NCT01271946|"~     The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne~     Access System in patients undergoing diagnostic angiographic procedures through the femoral~     artery.~   "
175195|NCT01271933|"~     The purpose of this study is to evaluate the efficacy and safety of a controlled release~     formulation of pregabalin administered once daily as compared to placebo in the treatment of~     fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo~     at some point in the study.~   "
175196|NCT01271920|"~     The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab~     in patients with Trastuzumab-refractory locally advanced or metastatic HER2+. The MTD is~     defined as the highest drug dosage not causing in the first cycle of treatment (28 days)~     medically unacceptable dose limiting toxicity (DLT).~      The phase II part of the trial will assess any potential effect on efficacy of adding AUY922~     to Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+~     breast cancer.~      Both AUY922 and Trastuzumab will be administered as a weekly IV infusion. Treatment should be~     continued as long as the patient does not have disease progression and tolerates the~     treatment. The following reasons are examples of acceptable reasons for discontinuing the~     study; tumor progression (by RECIST, as assessed by the investigator), unacceptable toxicity,~     death, or discontinuation from the study for any other reason, such as patient refusal,~     withdrawn consent, lost to follow-up or investigator decision.~   "
175197|NCT01271907|"~     Background:~        -  Recent cancer treatment studies have shown that altering a cancer patient's own white~          blood cells may help the immune system fight the cancer. In all of these studies,~          participants donate their own white blood cells through a procedure called~          leukapheresis, and the cells are altered in the laboratory and given back to the~          participants. After the cells are given, the patients receive aldesleukin (IL-2) to help~          the tumor fighting cells stay alive longer. For individuals with metastatic melanoma,~          pieces of melanoma proteins may be added to the collected white blood cells to help the~          immune system recognize and attack the cancer cells.~        -  Researchers are interested in testing a new process in which cells from fruit flies~          (Drosophila) are used to help the melanoma proteins attach to the white blood cells. The~          fruit fly cells die off shortly after the proteins are introduced to the white blood~          cells. Researchers are also interested in determining whether IL-2 treatment is~          necessary after this new cancer treatment process.~      Objectives:~        -  To test the safety and effectiveness of modified white blood cells (Drosophila-generated~          CTL) as a treatment for metastatic melanoma that has not responded to standard~          treatments.~        -  To determine whether IL-2 treatment improves the effectiveness of Drosophila-generated~          cytolytic T lymphocytes (CTL).~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma that~     has not responded to previous IL-2 treatment.~      Design:~        -  Participants will be screened with a physical examination and medical history, tumor~          imaging studies, and heart and lung function tests.~        -  Prior to treatment, participants will have an intravenous catheter inserted into the~          chest to administer the study drugs.~        -  Participants will have leukapheresis to provide white blood cells for laboratory~          modification.~        -  Seven days before the start of the treatment, participants will be admitted to the~          hospital to have chemotherapy with cyclophosphamide and fludarabine. These drugs will~          suppress the immune system to improve the effects of the treatment.~        -  One to four days after the last dose of chemotherapy, participants will receive the~          modified cells. Participants in the group that will receive IL-2 will begin to receive~          the treatment 24 hours after the cell infusion, every day for 5 days. All participants~          will receive filgrastim injections to help the body produce more white blood cells.~        -  Participants will recover in the hospital for about 7 to 12 days after the cell infusion~          or the last dose of IL-2. Participants will continue to receive medications and provide~          blood and tumor samples for testing.~        -  Participants will have regular followup visits to assess the effects of the treatment.~   "
175198|NCT01271894|"~     Safety and efficacy are key issues in antiretroviral therapy (ART) selection. Efavirenz (EFV)~     is an important component of combination ART in treatment naive individuals. Like many drugs,~     there are inter-individual differences in the efficacy and tolerability of EFV. The Encore1~     study provides an opportunity to examine the pharmacokinetics (PK)(processes by which a drug~     is absorbed, distributed, metabolized, and eliminated by the body) of EFV in blood samples~     collected over a 24-hour dosing interval in participants receiving either standard 600 mg or~     reduced 400 mg dose EFV once daily.~   "
180801|NCT01198392|"~     The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin~     versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced~     gastric cancer.~   "
175199|NCT01271881|"~     Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two~     areas of particular problems are the terminal portion of the cephalic vein near the shoulder~     and the central veins in the chest. Although angioplasty is standard of care the treated~     narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your~     dialysis access functional. Recently there has been introduction of a new technology called a~     covered stent graft. Initial studies suggest that placing this device across the area of~     narrowing leads to dialysis access staying open longer and needing less angioplasty~     treatments.~      This study is designed to compare angioplasty (standard of care) versus using a covered stent~     graft. The investigators will then look at the dialysis records and future fistulograms to~     see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial~     procedure.~   "
175200|NCT01271868|"~     The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects~     associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and~     control of hemorrhaging during prophylaxis) of IB1001 in previously treated pediatric~     subjects with hemophilia B.~   "
175201|NCT01271855|"~     This trial will evaluate whether the routine use of belladonna/opium (B&O) suppositories~     improve patients' self-reported pain control in the first 24-hours after delivery.~   "
175202|NCT01271842|"~     Influenza A (H1N1) v2009 infection was responsible throughout the world of viral pneumonia~     and severe pulmonary edema requiring rescue therapeutics such as extracorporeal oxygenation.~     To date, no data exist on the outcome of patients having developed acute respiratory distress~     syndrome (ARDS) due to influenza A (H1N1) v2009, and in particular in patients with very~     severe lung injury requiring extracorporeal oxygenation. Although data exist on long-term~     outcome of survivors of ARDS, the patients included in the observational studies were~     heterogeneous with various underlying disease. Moreover, no study compared the outcome of~     survivors of ARDS according to the need or not of extracorporeal oxygenation. We therefore~     conducted this prospective case-control study to compare the long term pulmonary and extra~     pulmonary function in 2 groups of patients, one with severe ARDS due to H1N1 requiring~     extracorporeal oxygenation (case), and the second with ARDS due to H1N1 but without need for~     extracorporeal oxygenation (control). Eighteen case patients with inclusion and without~     non-inclusion criteria were selected from our national registry, and 32 controls (with~     inclusion and exclusion criteria) were matched on age, sex, and body mass index. All 48~     patients will be contacted and asked to participate. Patients will be evaluate at least 9~     months after ICU discharge, looking for health-related quality of life, measured by the~     Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), post traumatic~     stress disorder, assessed by the Impact of Event Scale Anxiety, and depression, assessed by~     the Hospital and Depression Score. Pulmonary function testing, including VO2 max test on a~     static bike will be performed. Muscle weakness will be clinically evaluated by the medical~     council research (MRC) test, with an additional electromyography if the result of the test~     was <48/60. A CT-scan will be performed, looking for lung abnormalities (fibrosis...).~     Albumin and prealbumin will be measured to evaluate the nutritional status.~      Primary outcome measurement is carbon monoxide diffusion capacity. The primary hypothesis is~     that patients with extracorporeal oxygenation will have a carbon monoxide diffusion capacity~     lower than patients without extracorporeal oxygenation (15% difference between groups).~     Inclusion of 13 patients in the case group and 26 patients in the control group will allow~     testing this hypothesis with a statistical power of 80% (standard deviation 15%). Secondary~     outcome measures will be the quality of life, the presence or not of post-traumatic stress~     disorders, of anxiety and/or depression, the results of pulmonary function testing, of the~     CT-scan, and of muscle testing. All results will be compared in patients with and without~     extracorporeal oxygenation.~   "
175203|NCT01271829|"~     The purpose of this study is to examine the effect of incorporating avocados in meals on~     post-ingestion glycemic index, insulin response, sensations of satiety and on~     appetite-related gastrointestinal peptide and hormone release. Also the effect of consuming~     avocado containing meals on the caloric intake of participants in subsequent eating episodes~     will be explored.~      Each subject will participate in one intervention for one day, wait one or two weeks, come~     for another intervention, wait one or two weeks and come for a final intervention- three in~     total. Participants will be randomly assigned to one of six treatment sequences. Postprandial~     response to the control and two avocado-containing test meals will be assessed and compared~     using a 3 x 3 single blind cross-over design. The Subjects will be between 25 and 60 years~     old, female or male, with a BMI of 23 to 32, stable weight, no sports involvement,~     non-smoking and not dependent on caffeine. Thirty subjects will be recruited.~   "
175204|NCT01271816|"~     Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited condition~     characterized by life threatening heart racing, presenting with palpitations, cardiac arrest~     (collapse requiring an ambulance) or sudden death. The disease affects the right ventricle,~     the part of the heart that pumps blood to the lungs. ARVC is diagnosed with a wide range of~     tests that focus on the pumping function and the electrical signals from the right ventricle.~     These factors are summarized in a score that forms the ARVC Task Force Criteria. Genetic~     testing has identified 5 different genes that lead to ARVC, which are detected in about 60%~     of patients with ARVC. This allows doctors to test family members of the patient with ARVC to~     determine if they are at risk of developing the condition. Currently, family members undergo~     testing that includes imaging and electrical tests such as a 24-hour monitor to determine if~     they have evidence of ARVC. With increasing frequency, family members are found to have the~     gene that may lead to ARVC, but little or no evidence that their hearts are affected. This~     may be because the family member is too young to develop the condition, or that other factors~     that we do not understand have protected them from developing it.~      The PREPARE study will study 100 patients that carry a gene that can lead to ARVC, but do not~     have anything more than minor evidence that the condition is present. These patients will not~     have heart racing on their initial 24-hour monitor. These patients will undergo long term~     monitoring with an implanted heart monitor that is inserted with a minor surgical procedure,~     which will detect abnormal heart rhythms that may provide a clue that heart racing from ARVC~     is present that is not detected with a 24-hour monitor that is performed on an annual basis~     (St. Jude Confirm implantable loop recorder). These patients will be enrolled in 10 adult and~     pediatric centers across Canada, and followed for 3 years after their heart monitor is~     implanted. If heart racing is detected, patients will discuss these results with their doctor~     to discuss what it means to them.~   "
175205|NCT01271803|"~     This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will~     evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600~     mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E~     mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have~     progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are~     eligible. Participants will be assigned to different cohorts with escalating oral doses of~     vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage~     [DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until~     disease progression, unacceptable toxicity or any other discontinuation criterion is met.~   "
175206|NCT01271790|"~     This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug~     regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without~     Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).~   "
175207|NCT01271777|"~     The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at~     80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be~     made using a glucose clamp technique.~   "
175208|NCT01271764|"~     Tumor invasion and metastasis are the major causes of cancer-related death. Some studies have~     found that histone methyltransferases, such as EZH2, specifically affect metastasis in~     breast, gastric and prostate cancer. The functional roles of other members of the HMT family~     such as G9a in cancer remain obscure. Therefore, the investigators will investigate whether~     G9a have a role in recurrence/metastasis of endometrial cancer.~   "
175210|NCT01271738|"~     The goal of this study is to compare two different types of breast surgery. In the first~     type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and~     some of the tissue around the tumor called margins. The amount of breast tissue removed is~     similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor~     is too close to the margin. The primary goal of this study is to see if the additional~     margins can decrease the need to return to the operating room. Both types of surgery are well~     accepted, and participating in the study would not give you a better chance to cure the~     cancer. At present, most breast surgeons remove the tumor without the additional margins. For~     all patients who have this operation, there is a high incidence of return to the operating~     room for margins re-excision: as many as 40% as patients can have a re-operation.~      At present, we do not know if taking the additional margins prevents the cancer from~     returning in the breast or not. If the cancer comes back in your breast, this is a recurrence~     and your breast will have to be removed (mastectomy).~   "
175211|NCT01271725|"~     The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW~     2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who~     progress on afatinib monotherapy within this trial) as treatment in patients with~     HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the~     neoadjuvant or adjuvant setting~   "
175212|NCT01271712|"~     A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best~     supportive care versus placebo plus best supportive care for subjects with metastatic and/or~     unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite~     prior treatment with at least imatinib and sunitinib.~      The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival~     Follow up Period.~      Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of~     every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive~     best supportive care which excludes any disease specific anti cancer therapy such as any~     kinase inhibitor, chemotherapy, radiation therapy, or surgery.~      Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3~     months (through month 6), and every 8 weeks until the end of treatment, or more frequently if~     clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor~     progression is seen in a central radiology review.~      Subjects receiving placebo who experience disease progression may be offered active~     treatment.~      Subjects who experience progression during regorafenib treatment may continue open label~     treatment.~      All subjects will enter the Survival Follow-up Period upon discontinuation of randomized~     study treatment.~   "
175213|NCT01271699|"~     The association of Multiple Sclerosis (MS) and Fabry disease is known from own clinical~     experiences as well as from case reports in the literature, where symptoms and suspicious~     results in the brain MRI led to the misdiagnosis of Fabry patients as MS. Remarkably, those~     patients almost never showed oligoclonal bands or an intrathecally derived IgG-production was~     wrongly assumed due to misinterpretation of CSF results. Where oligoclonal bands were~     present, concomitant diagnoses had to be discussed. Furthermore, those patients showed no~     involvement of the spinal cord, as evidenced by MRI. Beside the possible complications of a~     not-effective and not-necessary MS therapy, those patients are at risk of irreparable organ~     damage due to the delayed implementation of enzyme replacement therapy for Fabry disease.~   "
175214|NCT01271686|"~     This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in~     patients with glaucoma or ocular hypertension~   "
175215|NCT01271673|"~     Breast cancer is the most common cancer among women residing in majority of the urban areas~     in India. The deaths due to breast cancer are mainly a result of late presentation of the~     symptoms due to lack of awareness of the signs and symptoms of the disease and lack of~     knowledge of performing BSE. The BSE technique can be a good tool for improving the awareness~     about the symptoms of breast cancer. Hence, we propose a pilot study of short duration (3~     months follow-up), to assess the level of compliance to BSE and assess the various reasons~     for non-compliance. Based on the results of this study a long term cohort study will be~     planned with similar objectives.~   "
175216|NCT01271660|"~     Muscle cramp is defined as a paroxysmal, involuntary, and painful contraction of skeletal~     muscle. Cirrhotic patients can encounter with muscle cramp frequently, which might be~     associated with poor quality of life. Gabapentin can be prescribed for muscle cramp. However,~     patients with liver cirrhosis have limited access to gabapentin which is metabolized~     primarily in liver.~      Pregabalin with a similar mechanism of action to gabapentin undergoes negligible metabolism~     owing to its improved pharmacokinetic properties. Thus, pregabalin might be a promising~     therapeutic option for patients with liver cirrhosis who are suffering from muscle cramp and~     susceptible to drug-induced hepatotoxicity.~      Therefore, the investigators hypothesize that pregabalin could effectively reduce painful~     symptoms derived from muscle cramp. In the current study, the investigators are going to~     evaluate the efficacy and safety of pregabalin by comparing outcomes between two groups~     (treatment group vs. placebo group).~   "
175217|NCT01271647|"~     The purpose of this study is to evaluate the efficacy and safety of the classic yin and yang~     tonic formula for osteopenia and to research the mechanism of efficacy.~   "
175218|NCT01271634|"~     The pathophysiologic basis of hemifacial spasm is cross-transmission between different~     branches of the facial nerve. The hypothesis is that the cross-transmission is mediated by~     the sympathetic nerve fibers on the surface of the offending artery. The abnormal potential~     from the offending vessel to the facial muscles will be detected on hemifacial spasm~     patients, so as to determine if the sympathetic nerve fibers take part in the circuit of~     cross-transmission.~   "
175219|NCT01271621|"~     Tracheal intubation with traditional Macintosh laryngoscope is associated with increase in~     intraocular pressure along with tachycardia and hypertension. These effects are not desirable~     in ophthalmic patients especially in patients with glaucoma. GlideScope video laryngoscope~     system is a new approach for laryngoscopy and tracheal intubation. It does not require a~     direct line of sight to the glottis when intubating with the Glidescope and as a result~     intubation is much less stimulating to the patient. Therefore GlideScope video laryngoscope~     assisted intubation could be a preferable technique for intraocular surgery offering~     advantages in terms of intraocular pressure and cardiovascular stability.~   "
175220|NCT01271608|"~     Comparing the pain intensity on a numeric scale (0-10) with intramuscular and subcutaneous~     injection between a retractable fixed syringe needle and the technique involving needle~     exchange; Comparing bruise formation following administration of insulin subcutaneous~     injections between RFS and the conventional technique.~      Method Study site A clinical trial was conducted in two medical-surgical units in a hospital~     in the period from June 15th to November 30th, 2009, after approval by the Ethics and~     Research Committee.~      Intervention In a group of patients the investigators used syringes with retractable fixed~     needle to administer subcutaneous and intramuscular injections. In the group of control, the~     investigators used the standard technique to administer medications.~      Population of study Patients were sequentially enrolled through a lottery system of exposure~     using random numbers kept in sealed, opaque envelopes.~      Sampling design and sample size Subcutaneous injection The sample size was based on the~     expected proportion of bruising following the injection. It was expected that 40% of patients~     would show bruising with the conventional technique and 20% with the technique under study~     for subcutaneous applications. With an alpha error of 5% (p = 0.05) and power of study of 80%~     (beta error of 20% or 0.2) 240 patients were included, 120 in each group.~      Intramuscular injection The sample size was based on the proportion of patients with moderate~     to severe pain. It was considered normal the incidence of moderate to severe pain in 30% with~     a needle exchange, whereas it was considered an increase of up to 40% with the retractable~     fixed needle. The investigators included 500 patients in each group.~   "
175221|NCT01271595|"~     There is inconclusive evidence whether acupuncture treatment is effective in the treatment of~     seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in~     SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of~     acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the~     DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of~     acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to~     investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic~     function in a sub-group of ACUSAR patients. Baseline values were compared to data from~     matched healthy controls.~   "
175222|NCT01271582|"~     The purpose of this study is to investigate the association between UGT1A1 polymorphisms and~     neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer~     treated with FOLFIRI regimen.~   "
175223|NCT01271569|"~     The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of~     Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by~     electroencephalogramderived assessment (Bispectral Index [BIS]) and to compare the dynamic~     properties of PropofolF to those of Propofol.~   "
175224|NCT01271556|"~     The cardiovascular component associated with COPD plays a major role in prognosis of the~     disease, being responsible of 25% of the deaths. Experimental and initial clinical data~     suggest that beta-adrenergic agonists accelerate clearance of excess fluid from the alveolar~     airspace, with potential positive effect on cardiogenic pulmonary edema.~      The aim of this study was to investigate the effects of a long-acting beta-2 agonist,~     salmeterol, on alveolar fluid clearance in COPD patients by evaluating the diffusive and~     mechanical lung properties. Our experimental model to test alveolar fluid clearance was rapid~     saline intravenous infusion.~      Ten COPD and 10 healthy subjects treated with salmeterol or placebo 4 hours before the begin~     of the study were evaluated, in four non consecutive days, just before and after a saline~     infusion or a similar period without infusion.~      Both in COPD and healthy subjects rapid saline infusion, with placebo or salmeterol~     premedication, lead to a significant decrease of DLCO and FEV1. Nonetheless, salmeterol~     pretreatment lead to a significant reduction of the impairment of gas exchange due to saline~     infusion (-64% of DLCO reduction in comparison with placebo), whilst it did not affect the~     changes in FEV1. In the control setting, with no infusion, we did not find any significant~     change of both DLCO and mechanical properties of the lung.~      In conclusions, in COPD patients salmeterol appears to provide a protective effect against an~     acute alveolar fluid clereance challenge secondary to lung fluid overload providing an~     intriguing mechanistic explanation for the benefits observed in larger trials.~   "
175225|NCT01271543|"~     Because of its simplicity of function and reliability, direct laryngoscopy it is routinely~     used for endotracheal intubation during general anesthesia. However, direct laryngoscopy is~     fraught with concerns for cardiovascular stimulation during induction of general anesthesia.~     This can be attributed to the placement of the laryngoscope blade into the vallecula and then~     applying force in an upward direction to expose the glottic opening. The average force~     necessary for visualization of the glottic opening is approximately 5.4kg. This can lead to~     significant pressor responses and tachycardia though stimuli to supraglottic region.~      An alternative airway management device is the Shikani optical stylet (SOS). It is an~     effective, safe and reusable intubation device that has been shown to be effective in cases~     of difficult intubation. It consists of a fiberoptic bundle within a J - shaped malleable~     stainless steel sheath. At the proximal end of the sheath is an eyepiece with an attachment~     to a light source. An adjustable tube stop firmly affixes the endotracheal tube to the~     stylet, and has a port to be able to deliver oxygen. (4) The operator inserts the tip of the~     stylet with the loaded endotracheal tube into the patient's oropharynx and under direct~     visualization through the eyepiece, is able to visualize the vocal cords. Because the end of~     the stylet is at the end of the endotracheal tube, it can be directly visualized to be~     entering trachea past the vocal cords.~      The investigators hypothesize that endotracheal intubation performed by the aid of SOS by~     minimizing oropharyngolaryngeal stimulation will result in fewer hemodynamic changes in~     patients with normal airways as compared with the MacIntosh laryngoscope.~   "
175226|NCT01271530|"~     The aim of this study is to investigate the effect of upper limb cardiovascular training on~     fitness, energy cost of walking, fatigue and pain in polio survivors. Polio survivors often~     have difficulty accessing aerobic forms of exercise due to limitations in mobility, pain~     associated with walking and fatigue. This can result in becoming physically unfit and places~     polio survivors at risk of secondary heath problems due to inactivity. A large percentage of~     polio survivors have lower limb involvement but have strong arms. The participants in this~     study will exercise at home using simple arm cycles for 8 weeks. They will attend for~     assessment on two occasions. All exercise will be prescribed by a Physiotherapist and~     includes measures to ensure safety while exercising at home.~   "
175227|NCT01271517|"~     Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve~     glycemic control during the first year of treatment of children/adolescents with type 1~     diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal~     balance of the GH-IGF-axis.~      This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age,~     newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting~     basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of~     treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin)~     when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart).~     The investigators will explore possible mechanisms of action by determining remaining~     endogenous insulin production and changes in the GH-IGF-axis. The investigators will also~     assess changes in body composition and evaluate quality of life in each treatment arm.~   "
175228|NCT01271504|"~     The purpose of this study is to determine whether patients with hepatocellular carcinoma who~     receive either E7050 administered with Sorafenib or Sorafenib alone experience greater~     benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.~   "
175229|NCT01271491|"~     Bronchiolitis is a potentially severe infection of the airway in infants and children, and~     among the most frequent diagnoses leading to pediatric intensive care unit admission in~     infants. This acute infection is caused by an array of viruses, but respiratory syncytial~     virus (RSV) is the most frequently implicated. The majority of infants hospitalized with~     bronchiolitis are previously healthy, and half of infants intubated and mechanically~     ventilated for respiratory failure due to RSV bronchiolitis have no previously identified~     risk factors. It is likely, therefore, that other factors, particularly genetic heterogeneity~     of the host, contribute to disease severity. However, no previous study has investigated the~     association of genetic variants with respiratory failure in children with bronchiolitis.~     Several categories of candidate genes have emerged as potentially important in the~     pathogenesis of the disease. Specifically, genetic polymorphisms of surfactants, pattern~     recognition receptors, receptor adhesion molecules, and cytokines have been examined. The aim~     is to evaluate these polymorphisms to determine their association with respiratory failure in~     a cohort of more severely ill children with bronchiolitis.~   "
175230|NCT01271478|"~     The aim of this study was to compare the dual use of telmisartan and captopril vs the~     individual use of such drugs and placebo on the systemic inflammation of patients on~     hemodialysis (HD).~   "
175231|NCT01271465|"~     The purpose of this study is to see if substances measured in a small piece of the donor~     organ predicts how well the organ will function in the recipient after transplant. We will be~     testing blood, urine, and biopsy tissue samples in this study. The research team will be~     looking at different risk factors in the donor organ that predict how well the kidney will do~     in the recipient.~   "
175232|NCT01271452|"~     This study will evaluate the safety and efficacy of two different types of botulinum toxin~     type A for the treatment of glabellar frown lines.~   "
175233|NCT01271439|"~     This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate~     acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy~     in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship~     between patient outcome and EGFR gene copy number, expression and mutation.~   "
175234|NCT01271426|"~     To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2~     (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal~     vasculopathy (PCV) with ranibizumab.~   "
175235|NCT01271413|"~     This research is being done to learn if computer tasks that challenge the brain (cognitively~     stimulating tasks) can improve memory and other types of thinking. The study will compare the~     effects of different versions of the computer tasks. It also will compare the task~     performance of different groups of people.~   "
175236|NCT01271400|"~     The aim of this study is to track the outcome from the patients who had embryo~     cryopreservation as part of their Advanced Reproductive Technology (ART) treatment at West~     Coast Fertility Centers.~   "
175237|NCT01271387|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of tasimelteon (including its breakdown products) in the blood in individuals with~     mild or moderate liver disease compared to individuals who have normal liver function.~   "
175238|NCT01271374|"~     The purpose of the study is to compare the effects of Azor (a combination of amlodipine and~     olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin~     lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood~     pressure normal.~   "
175239|NCT01271361|"~     The purpose of the study it to evaluate whether primary percutaneous coronary intervention~     (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy~     increases minimal flow area after stenting for treatment of patients presenting with~     ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.~   "
175240|NCT01271348|"~     Comparison of the effect of etoricoxib to placebo on muscle pain caused by eccentric~     contractions~   "
175241|NCT01271335|"~     A prospective, three-center, phase I safety and tolerability dose escalation study,~     evaluating 28 subjects in 4 discrete dose cohorts of acute intracoronary injected collagenase~     ranging from 300 - 1200 µg prior to routine standard-of-care percutaneous revascularization~     procedures in subjects with chronic total coronary artery occlusions (CTOs).~   "
175251|NCT01271205|"~     Abstract Pneumonia is a leading cause of severe morbidity and mortality among adults. During~     the last two decades, several scores were developed to evaluate the probability of morbidity~     and mortality among patients with community acquired pneumonia (CAP), such as the PORT score~     and the CURB65. Recently, several studies showed that elevated Red Cell Distribution Width~     (RDW) could be used as a prognostic tool for predicting severe morbidity and mortality among~     patients with cardiac diseases.~      RDW is a quantitative measure for red blood cell (RBC) size variability. Recent studies have~     suggested that high levels of RDW are in association with higher mortality among~     cardiovascular patients.~      RDW has not yet been studied as a prognostic sign in CAP. The goal of this study is to~     examine the role of RDW as a prognostic factor for severe morbidity and mortality among~     patients who were hospitalized with CAP , independently to Hemoglobin levels, renal function~     and inflammatory markers.~   "
175242|NCT01271322|"~     Prospective, single-center, nonrandomized, explorative imaging study evaluating the value of~     PET as a predictor of histopathological response in metabolic non-responders Patients with~     resectable AEG (adenocarcinoma of the esophagogastric junction) type I and II (cT3/4 and/or~     cN+ and cM0)~      Metabolic non-responders, showing a <35% decrease of SUV (standardized uptake value) two~     weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to~     intensified taxane-based RCT (radiochemotherapy) before surgery. 18FDG-PET scans will be~     performed before (=Baseline) and after 14 days of standard neoadjuvant therapy as well after~     the first cycle of Taxotere/Cisplatin chemotherapy (=PET1) and at the end of intensified~     radiochemotherapy (PET2).~      Tracer uptake will be assessed semiquantitatively using standardized uptake values (SUV). The~     percentage difference Delta SUV=100(SUVBaseline-SUVPET1)/ SUVBaseline will be calculated and~     assessed as an early predictor of histopathological response. In a secondary analysis, the~     association between the difference SUVPET1 - SUVPET2 and histopathological response will be~     evaluated.~   "
175243|NCT01271309|"~     The present project aims to determine whether a deficit in migration of stem cells could be~     implicated in the failure to mount an adequate collateralization after Myocardial Infarction~     (MI) and thereby facilitate the development of post-ischemic heart failure (HF) and to~     dissect underlying molecular mechanisms. Furthermore, the investigators wish to determine the~     predictive value of stem cell migration assay in patients with MI.~   "
175244|NCT01271296|"~     Addison's disease is a rare disease, wherein the adrenals can not produce sufficient steroid~     hormones (cortisol and aldosterone). Patients with Addison's disease report impaired~     subjective health status, and they have increased all-cause mortality. Conventional therapy~     is by oral replacement of glucocorticoid and mineralocorticoid hormones, but this strategy~     imperfectly mimic the diurnal cortisol variations, and render the patients both over- and~     under-treated. Anecdotally, some patients with adrenal insufficiency may benefit from the use~     of various nutritional compounds. We hypothesised that liquorice and grapefruit altered the~     metabolism and absorption of cortisone acetate.~   "
175245|NCT01271283|"~     This phase II clinical trial is studying how well lenalidomide works in treating patients~     with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may~     stimulate the immune system in different ways and stop cancer cells from growing.~   "
175246|NCT01271270|"~     Background:~        -  Wet age-related macular degeneration (AMD) occurs when abnormal blood vessels grow in~          the back of the eye, and leak blood and other fluids that damage the eye, produce~          scarring, and lead to blindness. People diagnosed with wet AMD have increased production~          of a body chemical called vascular endothelial growth factor (VEGF). VEGF is important~          in the formation of blood vessels in the body, and decreasing the production of VEGF is~          believed to help wet AMD patients by preventing or slowing the growth of the abnormal~          blood vessels. Anti-VEGF drugs have been used to decrease the production of VEGF, but~          some people do not respond completely to these drugs.~        -  A protein in the body called mTOR also plays a critical role in regulating how cells~          divide and grow and obtain their blood supply. The experimental chemical Palomid 529~          inhibits the production of mTOR. Researchers are interested in determining whether~          Palomid 529 is safe and can help individuals with wet AMD who have not completely~          responded to anti-VEGF treatments.~      Objectives:~      - To evaluate the safety and effectiveness of Palomid 529 as a treatment for wet age-related~     macular degeneration in individuals who have not responded to standard anti-VEGF treatments.~      Eligibility:~      - Individuals with wet age-related macular degeneration in at least one eye that has not~     responded to standard anti-VEGF treatments.~      Design:~        -  Prior to the first visit, participants should have been seen at the National Eye~          Institute clinic under a screening or teaching protocol, or NIH protocol 08-EI-0103,~          High Speed Indocyanine Green Angiography Findings in Induction Regimen of Intravitreal~          Ranibizumab Injection for Neovascular Age Related Macular Degeneration. One eye will be~          designated as the study eye to receive the Palomid 529 treatment.~        -  Participants will have a full physical examination and medical history, a full eye~          examination to evaluate eye health and vision, angiography to examine the blood vessels~          in the eyes, and blood and urine tests during the study~        -  Participants will receive an injection of Palomid 529 into the study eye every 4 weeks~          during the study, for a total of three injections. Participants may also receive~          anti-VEGF injections such as ranibizumab (Lucentis ) or bevacizumab (Avastin ) in the~          study eye 12 days before and 12 days after the Palomid 529 injection.~        -  Participants may have standard-of-care treatments for the non-study eye if it has wet~          AMD as well, but may not receive experimental treatments in the non-study eye while they~          are in this study.~        -  Participants will return for long-term follow-up examinations as directed by the study~          researchers.~   "
175247|NCT01271257|"~     The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral~     misoprostol.~   "
175248|NCT01271244|"~     The study looked at relationship between escitalopram and heart rate variability and QT~     variability in veterans with PTSD.~   "
175249|NCT01271231|"~     Diabetes is a metabolic disorder that affects the uptake of glucose into cells. This causes a~     cascade of systemic alterations that may lead to kidney failure, cardiovascular~     complications, altered tissue healing, retinopathies and gangrene. Diabetes is also~     associated to increased susceptibility to infections and inflammation.~      It has been observed that diabetic patients suffer more often from oral infections such as~     periodontal disease. Periodontal disease is an infectious-inflammatory disease that leads to~     destruction of the surrounding tissues of the tooth. It is proposed that the mechanisms~     responsible for systemic complication are implicated in the development of periodontal~     disease. This has been evaluated in studies where diabetic patients showed increased levels~     of inflammatory cytokines, subgingival bacteria and limited response to treatment. Its has~     also been suggested that established periodontitis in the diabetic patient leads to insulin~     resistance due to infection and liberation of cytokines from periodontal tissues and thus~     worsening the diabetic condition.~      This study is aimed to establish the response to periodontal treatment with antibiotics and~     the kinetics of glucose levels in diabetic patients.~   "
175250|NCT01271218|"~     Background: Exercise, weight loss, and dietary supplementation of glucosamine and chondroitin~     (GC) have been reported to improve functional capacity in individuals with knee~     osteoarthritis (OA). The purpose of this study was 1.) to determine whether women with knee~     OA who follow a higher protein diet observe more favorable changes in body composition and/or~     markers of health compared to those following a standard higher carbohydrate-based diet; and,~     2.) to determine whether dietary supplementation of glucosamine and chondroitin during a~     weight loss and fitness program lessens symptoms of pain, improves functional capacity,~     and/or promotes greater health benefits in women with knee OA. It was hypothesized that both~     groups would experience beneficial changes in body mass, body composition, and markers of~     health. However, greater benefits would be observed in those following a higher protein diet~     while supplementing the diet with glucosamine and chondroitin.~   "
175252|NCT01271192|"~     RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for~     resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy~     is still unknown.~      PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed~     by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative~     chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect~     of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.~   "
175253|NCT01271179|"~     The study was designed to investigate whether, compared with conventional sole perfusion with~     high-viscosity solution of University of Wisconsin (UW), sequential perfusion of liver grafts~     with low-viscosity and high-viscosity preservation solutions could further decrease the~     incidence of nonanastomotic biliary strictures (NAS) after liver transplantation.~   "
175254|NCT01271166|"~     This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of~     Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level~     in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to~     the toxicities observed. Once the MTD has been determined the dose level below will be~     re-opened and extra patients, to a total of 15, will be enrolled.~   "
175255|NCT01271153|"~     The investigators hypothesize that dobutamine is able to revert negative redistribution of~     flow by inducing a selective vasodilatory effect on hypoperfused territories, particularly at~     the sublingual and gastric mucosa, and at the peripheral tissues.~      The investigators designed a randomized, cross-over, placebo-controlled study looking at the~     acute physiologic effects of 5 mcg/kg/min fixed-dose of dobutamine on cardiac function,~     microcirculation, gastric mucosal, hepatosplanchnic, and peripheral perfusion in septic shock~     patients.~   "
175256|NCT01271140|"~     Insulin resistance is one of the key factors in defining a progressive course of chronic~     Hepatitis C virus (HCV) infection and hepatic fibrosis. Multiple trials have targeted insulin~     resistance as an adjuvant way to manage hepatitis C liver disease with promising results.~      Long term therapy using high dose insulin was shown to significantly reduce insulin~     resistance in obese patients. In cardiac and critically ill patients, long term insulin was~     shown to produce better outcomes mainly by reducing the overt inflammatory response.~     Furthermore, initial results of ongoing trials are revealing more benefits of insulin~     therapy. Using the (hyperinsulinimic normoglycemic clamp) for eight hours on patients~     undergoing major liver resection was able to maximize their liver function post-operatively.~     This trial also demonstrated inhibition of the inflammatory response, improvement in liver~     glycogen, inhibition of apoptosis and stimulation of liver regeneration.~      Putting in mind the potential ability of the liver to regenerate and regain better function.~     The anti-inflammatory properties of insulin therapy along with its ability to reduce insulin~     resistance over time has led us to see the potential benefits of using insulin therapy on~     patients with chronic hepatitis C virus liver cirrhosis. Insulin will target the~     pathophysiology of the disease at a cellular and a molecular level.~      The investigators theorize that long-term high insulin therapy would be able to promote~     better liver function and slow down fibrosis and injury in this population of patients.~   "
175257|NCT01271127|"~     Survivors of Hodgkin Lymphoma (HL) are known to have an increased risk of developing late~     treatment sequelae such as cardiovascular events due to coronary artery disease. At present~     no active screening is performed in these patients since it is not known whether screening~     and subsequent treatment by means of revascularization is effective in reducing the risk of~     cardiovascular events in symptomatic individuals. In the trial the efficacy and therapeutic~     consequences of screening for coronary artery diasease by multi-slice CT (MSCT) among~     asymptomatic HL survivors will be evaluated.~   "
175258|NCT01271114|"~     In hypotensive septic patients with controlled source, an hemodynamic management protocol~     including hypertonic saline (HS)and terlipressin improves MOD (Multiple Organ Dysfunction)~     Score by at least 3 points compared to the use of physiologic saline and norepinephrine.~      The appropriate design for this trial would be factorial. For the time being, will consider~     de intervention as a whole unit for this pilot study. In the future an appropriately sized~     factorial multicentric study shall be necessary.~      Other goals of the pilot study:~        1. HS restores preload parameters adequately~        2. HS associated with terlipressin normalizes blood pressure in septic shock~        3. HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L~        4. There is an inverse relationship between plasma sodium and procalcitonin levels~        5. HS increases plasma levels of vasopressin (AVP)~        6. HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)~   "
175259|NCT01271101|"~     The primary objective of the EASY-CHINA Registry is to describe the clinical epidemiology of~     Chinese patients with NSTE-ACS, to evaluate their current anticoagulation management in~     China, and the resources used for it.~   "
175260|NCT01271088|"~     Peritonitis is currently one of the leading complications of continuous ambulatory peritoneal~     dialysis (CAPD). Aminoglycosides and vancomycin are used in the treatment of CAPD peritonitis~     despite their potential risk for ototoxicity. NAC is a molecule used in the treatment and~     prophylaxis of many diseases related to oxidative stress. The aim of this study was to~     examine whether ototoxicity due to antibiotics used in the treatment of CAPD peritonitis can~     be prevented by N-acetylcysteine~   "
175261|NCT01271075|"~     This is a double-blind, triple cross-over, placebo-controlled study to assess the efficacy,~     mechanisms, and safety of treatment with the antihistamine bilastine in patients with cold~     contact urticaria (CCU).~      Efficacy is primarily assessed by a change in critical stimulation time thresholds (CSTT) and~     critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20~     mg, 40 mg, 80 mg). Following a baseline period of 2-4 weeks, patients are randomized to~     either group A or group B. In group A they are given bilastine 20 mg, 40 mg, placebo and~     bilastine 80 mg for 7 days each followed by a 14-day washout period at a time. In group B~     they are given bilastine 80 mg, placebo, 40 mg and 20 mg for 7 days each followed by a 14-day~     washout period at a time. CSTT and CTT testings are performed at each of 6 visits, skin~     microdialysis for the assessment of mast cell mediators is performed at V2, V3 and V6. Visits~     for investigator's assessments are scheduled at day -14 to -28, day 0, day 7, day 28, day 49,~     and day 70. Overall a max. of 20 subjects with cold contact urticaria will be enrolled.~   "
175262|NCT01271062|"~     Bariatric operations such as the gastric bypass procedure provide a unique in vivo model of~     improvement of pathological beta cell function. The presented double-centre study aims to~     comprehensively investigate different aspects of beta cell function in patients with type 2~     diabetes (T2DM) with a wide range of disease duration after gastric bypass. In parallel, our~     project will address the aspects of changes in enteroinsular and adipoinsular axes as well as~     the early and late changes of other defined parameters after gastric bypass surgery.~   "
175263|NCT01271049|"~     The prevalence of intestinal helminths is worldwide. This study will evaluate the~     tolerability of a novel food product consumed by adults residing in an area endemic for~     helminths.~   "
175265|NCT01271023|"~     The purpose of this study is to test an insulin management system (Control-to-Range (CTR)~     system) in an inpatient setting to see if the system is safe and effective enough to test in~     a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose~     Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines~     how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the~     insulin.~      The study will include two hospital stays consisting of meals and exercise scenarios. Both~     hospital stays will be for 24+ hours during the day and night. The study will include about~     50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.~   "
175266|NCT01271010|"~     This multi-center, single-arm study evaluated the efficacy and safety of rituximab in~     combination with fludarabine and cyclophosphamide in participants with B-cell chronic~     lymphocytic leukemia (CLL) and favorable somatic status.~   "
175267|NCT01270997|"~     The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in~     combination with Methotrexate in patients with rheumatoid arthritis.~   "
175268|NCT01270984|"~     The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic~     characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when~     administered a single-dose to healthy volunteers.~   "
175269|NCT01270971|"~     The purpose of this study is to determine whether AN2690 topical solution is a safe and~     effective treatment for onychomycosis of the toenail.~   "
175270|NCT01270958|"~     Allergic rhinitis is an IgE-mediated, inflammatory disorder of the upper airway that occurs~     following allergen exposure. Perennial Allergic Rhinitis (PAR) starts in early childhood and~     occurs all year around. It's caused by allergy to the aerosolised droppings of house dust~     mites and pet skin flakes (dander). Occasionally, indoor mould spores and, in rare cases,~     food allergy can be causes.~      Intranasal corticosteroids are highly effective medications for controlling the nasal~     symptoms that accompany allergic rhinitis.~      AVAMYS (TM) (fluticasone furoate aqueous nasal spray 100mcg) has been shown having effects on~     nasal symptoms of seasonal and perennial allergic rhinitis and on the ocular symptoms of~     allergic rhinitis and has been evaluated as effective and safe for treatment seasonal and~     perennial allergic rhinitis by FDA. It is speculated that AVAMYS (TM) is also effective and~     safe for Vietnamese patients. However before being used widely for patients across the~     country, AVAMYS (TM) should be proved that it is safe for Vietnamese patients.~      The objective of this study is to evaluate the safety of fluticasone furoate aqueous nasal~     spray 110mcg once daily in adults with PAR.~      This is a 6-week, open trial. A study center will be enlisted to recruit a minimum of 50 PAR~     subjects.~      At the visit 1, subjects who fulfill the inclusion criteria are eligible to be included in~     the group to self-administer intranasal treatment of fluticasone furoate aqueous nasal spray~     110 mcg once daily for 6 week. The subjects are instructed to administer two sprays from the~     device into each nostril once daily every morning. Administration of the dose will be~     performed by alternately spraying one spray to each nostril followed by a second spray to~     each nostril. Subjects will not be permitted to take any anti-allergy or rhinitis medication~     during the screening or treatment period.~      Throughout the study, subjects will document their study drug administration/compliance, any~     medical conditions experienced, and any concomitant medications taken. All subjects are~     outpatients.~      The safety assessments include a summary of the frequency and type of clinical adverse events~     that occur during the study. In addition, hematology and chemistry analyses of blood samples~     are also implemented. A physical examination and nasal examination are also performed and~     vital signs collected. Twelve-lead ECGs are performed at all visits.~   "
175271|NCT01270945|"~     The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or~     the time to restenosis in patients undergoing repeat peripheral artery revascularization~     versus controls randomized to standard of care.~   "
175272|NCT01270932|"~     Primary:~      • To validate the initial dosing recommendations for newly diagnosed MM (Mutiple Myeloma)~     patients with various degrees of renal failure using pharmacokinetic studies~      Secondary:~        -  To evaluate the safety of lenalidomide and dexamethasone as induction therapy in~          newly-diagnosed MM (Multiple Myeloma) patients with renal dysfunction using modified~          dosing guidelines~        -  To evaluate clinical response of lenalidomide and dexamethasone after 4 cycles using the~          modified dosing guidelines~        -  To evaluate the ability to collect stem cells after 4 cycles of lenalidomide and~          dexamethasone induction therapy in MM (Multiple Myeloma) patients with renal failure~   "
175273|NCT01270919|"~     To demonstrate repair of the meniscus at 6 months, as evaluated by MRI, will be observed; and~     clinical qualitative assessments will improve from preoperative to postoperative time points~     with the BioDuct® Meniscal Repair Device.~   "
175274|NCT01270906|"~     Phase I dose finding study in solid tumors.~   "
175275|NCT01270893|"~     The goal of this clinical research study is to learn if Tasigna® (nilotinib) can cause tumor~     cells to shrink and/or die in patients with GIST who are scheduled for surgery or may be~     eligible for surgery. The safety of this drug will be studied. Researchers also want to use~     imaging scans to study the changes in tumor size that may be caused by using nilotinib.~   "
175276|NCT01270880|"~     Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins~     needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090~     works in treating patients with metastatic hormone-resistant prostate cancer previously~     treated with docetaxel-based chemotherapy~   "
175277|NCT01270867|"~     To determine if the Trevo Retriever is as good or better than the Merci Retriever in~     restoring blood flow to the brain of a patient experiencing an acute ischemic stroke in a~     large vessel.~   "
175278|NCT01270854|"~     The purpose of this study is to determine whether an intravenous salt solution called~     Plasmalyte causes less abnormality of the body's acid levels than a solution called Normal~     Saline.~   "
175279|NCT01270841|"~     The Purpose of the study is to determine the effects of Androxal on morning testosterone and~     reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less~     than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The~     effects of Testim versus placebo on reproductive status will also be examined. Study subjects~     must not be currently using a topical testosterone.~   "
175280|NCT01270828|"~     The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin~     formulation versus placebo for patients with post herpetic neuralgia (Shingles)~   "
175281|NCT01270815|"~     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a~     pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or~     800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2)~     evaluate the safety and tolerability of a single dose of a pregabalin controlled release~     tablet following various sized lunches as compared to a single dose of the pregabalin~     immediate release capsule.~   "
175282|NCT01270802|"~     Efavirenz, a commonly used HIV medication, may cause worsening vascular function and bone~     problems. The purpose of this study is to determine if switching efavirenz to raltegravir, a~     newer HIV medication, will improve vascular function and tests of bone health.~   "
175283|NCT01270789|"~     Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive~     deterioration in the function of the pancreatic beta-cells, which are the cells that produce~     and secrete insulin (the hormone primarily responsible for the handling of glucose in the~     body). We propose a double-blind, randomized controlled study comparing the effect of~     liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo,~     on the preservation of beta-cell function over one year in patients with T2DM. This study may~     demonstrate an important beta-cell protective capacity of liraglutide.~   "
175284|NCT01270776|"~     The purpose of this study is to compare the efficacy of two different antiseptic solutions~     (2%chlorhexidine in 70% alcohol with 2% aqueous chlorhexidine)when used in a standardized~     controlled manner in cleansing the skin of infants with birth weight less than 1500 grams~     prior to a skin breaking procedure (venepuncture).~      The investigators hypothesize that the use of limited amount of 2% aqueous chlorhexidine~     solution will be as effective as the same amount of 2% chlorhexidine in 70% alcohol for skin~     antisepsis and that limited exposure to 2% aqueous CHG may be associated with less adverse~     skin reactions.~      Literature from adults has shown that both 2% chlorhexidine in 70% alcohol as well as 2%~     aqueous chlorhexidine can provide effective skin antisepsis though alcohol containing~     solution had more long lasting effect. It is also well known from many case reports that~     alcohol containing products when used to clean abdominal skin for neonatal procedures can~     cause severe skin damage in preterm infants. This has lead many neonatal units to adopt~     aqueous chlorhexidine as the antiseptic agent of choice without robust evidence to support~     its use or standardization of method of application.Both these solutions are widely used in~     neonatal intensive care units across the globe including Canada.~      By conducting this trial, the investigators want to evaluate the efficacy and safety of 2%~     aqueous chlorhexidine as an antiseptic agent when used in a controlled manner [limited amount~     for short duration].~   "
175285|NCT01270763|"~     The interplay of genetic and behavioral factors is critical to understanding obesity.~     Behavioral weight loss intervention has emerged as a key strategy in combating obesity.~     However, individuals differ in their degree of success in these programs and genetic factors~     are known to play a role. In this application, the investigators propose to identify specific~     genes that predict individual differences in weight loss and high density lipoprotein~     cholesterol in response to behavioral intervention to help identify individuals that struggle~     with weight loss and cholesterol despite behavioral efforts.~   "
175286|NCT01270750|"~     Vasoconstrictive signaling via endothelin receptors is not limited to primary pulmonary~     arterial hypertension, but has also been documented in secondary pulmonary hypertension due~     to congestive heart failure, including cardiac valve disease. The investigators aim to~     examine the clinical and physiologic effects of bosentan therapy in patients with secondary~     pulmonary hypertension due to severe, inoperable cardiac valve disease, using a~     single-center, prospective, open-label, non-randomized study of oral bosentan in outpatients~     with severe mitral stenosis due to childhood rheumatoid fever. Primary end-point will be~     exercise capacity at six months determined by six-minute walking distance and cardiopulmonary~     exercise testing. Secondary end-points will be symptomatic relief, echocardiographic left~     ventricular function and pulmonary pressure, serum pro-brain natriuretic peptide, and adverse~     events at six months.~   "
175287|NCT01270737|"~     The investigators hypothesize that whole soy or purified daidzein alone could reduce blood~     pressure and CVD risks in equol-producing menopausal Chinese women.~   "
175288|NCT01270724|"~     This study will look to see how well patients with relapsed or recurrent intracranial germ~     cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine,~     Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous~     stem cell rescue.~   "
175289|NCT01270711|"~     The overall goal of this study will be to assess and monitor the adherence to and~     effectiveness of the new prescribing guidelines for cabergoline.~      Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson,~     hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline~     treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed~     doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography prior~     and during treatment. 5. The incidence and prevalence of valvular fibrosis~   "
175290|NCT01270698|"~     This is a Phase I trial to study the safety of IMMU-130. IMMU-130 is composed of a drug~     attached to an antibody. The drug is the active ingredient in irinotecan which is a common~     chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the~     immune system. They bind to substances that don't belong in the body to prevent harm to the~     body. The antibody in this study was designed to bind to a marker located on colorectal~     cancer tumors. The antibody was originally made from mouse proteins, but was changed in the~     laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts~     for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is~     safe.~   "
175291|NCT01270685|"~     The purpose of this study is to evaluate specific approaches used to prevent/reduce influenza~     transmission in the SCI/D System of Care in response to the 2009 H1N1 pandemic, including~     assessing infection control strategies used by SCI staff and guidance provided by local~     infection control units. Due to the rapid spread of and uncertainties about the H1N1 virus,~     we will evaluate patient's beliefs, behaviors, and information seeking strategies (e.g.,~     social media). These findings will lend to the understanding of ways to handle emergent~     issues, such as the H1N1 pandemic, in special populations.~   "
175292|NCT01270672|"~     The purpose of this study is to determinate the effect of a pre-treatment with carvedilol, a~     alpha- and beta-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of~     3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The investigators hypothesize that~     carvedilol will attenuate the cardiovascular and subjective response to MDMA.~   "
175293|NCT01270659|"~     The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia~     in comparison to standard analgesia, to determine if the FBT allows for faster achievement of~     significant analgesia~   "
175337|NCT01270087|"~     The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab~     (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid~     arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment~     and after 3 months, and related to other biomarkers and clinical outcomes.~   "
175294|NCT01270646|"~     Impact of intraventricular electrical activation in resynchronization therapy. We seek to~     evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of~     the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to~     decrease the heterogeneity of LV activation in heart failure patients. A second goal is to~     evaluate the electrical determinant of clinical response to CRT using invasive and~     non-invasive mapping technology.~   "
175295|NCT01270633|"~     The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix~     and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with~     controlled diabetes mellitus and without significantly compromised arterial circulation.~   "
175296|NCT01270620|"~     You are invited to participate in a research study assessing your mental status in the first~     days after your surgery and how you will be doing in the 2 years following the surgery. The~     investigators hope to learn more about the incidence of postoperative confusion and a~     possible relation with 2 anesthesia techniques that are routinely used. The first one is an~     anesthesia technique that uses the inhaled anesthetic gas desflurane and the second one is an~     anesthesia technique that uses the anesthetic propofol administered by infusion in a vein.~     The investigators are also looking to see if there is a relationship between anesthesia~     technique and cardiovascular outcomes. You were selected as a possible participant in this~     study because at your age this phenomenon appears to have a greater incidence.~   "
175297|NCT01270607|"~     The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia~     pain, via alterations in the processing of pain in the central nervous system.~   "
175298|NCT01270594|"~     Hypothesis: Can a counseling intervention, delivered by a pharmacist, increase inhaler~     adherence in veterans with COPD who have demonstrated poor inhaler adherence through pharmacy~     refill records?~      Veterans who receive who receive daily maintenance inhalers from the William S Middleton~     Memorial Veterans Hospital Pharmacy and who have a medication possession ratio less than 80%~     over the previous six months will be invited to participate in the study. This study will~     randomize 100 participants to a usual care arm or a pharmacist counseling intervention. Final~     data collection will be six months after randomization to determine if both self-reported and~     refill record adherence has changed.~   "
175299|NCT01270581|"~     The primary objective is to determine whether High Flow Nasal Cannula (HFNC) is a superior~     respiratory modality for neonates ≥36 weeks with transient tachypnea of the newborn (TTN)~     when compared to the standard of care modality (NCPAP).~   "
175300|NCT01270568|"~     This study is investigating whether a series of psychological exercises, called positive~     psychology, provides benefit to patients who have been hospitalized for heart disease (an~     'acute coronary syndrome' or heart failure).~      In this study, subjects are randomly assigned to complete 8 positive psychology exercises~     over 8 weeks, or to complete different exercises in control groups.~      We hypothesize that patients who are assigned to the positive psychology tasks will be able~     to complete the exercises at a high rate, will feel that the exercises were easy to perform,~     and will have greater improvements of optimism, anxiety, mood, and health-related quality of~     life than subjects in the control conditions.~   "
175301|NCT01270555|"~     The investigators propose to conduct an open study to evaluate the efficacy and tolerability~     of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or~     current substance use disorders. We hypothesize that Bupropion SR will be effective in~     treating ADHD in this population.~   "
175302|NCT01270542|"~     The purpose of this study is to determine the effect of anti-VEGF drug (Avastin)~     adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in~     patients with Proliferative Diabetic Retinopathy (PDR).~   "
175303|NCT01270529|"~     Hypothesis #1: Most children with CKD stages 2-4, ESRD and kidney transplantation will report~     participation in physical activity that falls short of recommended levels of physical~     activity; Children on dialysis will be less active.~      Hypothesis #2: Patients will endorse many barriers to physical activity, some of which will~     be related to their disease or its treatment; those who are less active will endorse more~     barriers.~      Hypothesis #3: Patients will increase their participation in physical activity in response to~     a pedometer-based 12 week intervention.~      Baseline level of physical activity and magnitude of increase in physical activity will be~     more closely associated with change in physical functioning and performance than stage of~     kidney disease or type of renal replacement therapy.~      Exercise capacity of the child will be measured by the six minute walk test whereby the~     subject will asked to walk as far as possible in 6 minutes in a straight corridor.~      Body fat or body composition will then be measured by Bioelectric Impedance Spectroscopy.~      Physical functioning or Health Related Quality of Life will be assessed self reported/ parent~     proxy reliable and validated questionnaire specifically designed for child with chronic~     kidney disease called Pediatric Quality of Life Inventory (Peds QL 4.0). Subjects (teens) or~     parents will also be asked to fill out a questionnaire on barriers to physical activity on~     their first visit.~      Physical activity will be measured in the form of daily steps. The child will wear the~     pedometer for the first week to assess his/her baseline level of activity. Then the child~     will continue to wear the pedometer for another 12 weeks during which time he or she will be~     asked to gradually increase steps walked per day above baseline physical activity. The~     patient will be called once a week in order to monitor progress, set new weekly step goals~     (usually 500-1000 steps/day greater than the previous week), and motivate the participant.~      After 12 weeks of the pedometer-based intervention to increase physical activity, physical~     performance, body composition and physical functioning (as described above) will be measured~     once again to assess the effect of increased physical activity on a second visit.~   "
175304|NCT01270516|"~     The investigators will determine if administration of HMB (hydroxymethylbutyrate) or EPA~     (eicosapentaenoic acid) will increase diaphragm and limb muscle strength for patients on~     breathing machines in an intensive care unit. The investigators will first measure the~     strength of the diaphragm and a limb muscle (the quadriceps)using magnetic stimulators to~     activate these muscles. Muscle size will be measured by using an ultrasound to measure~     diaphragm thickness and quadriceps thickness. The investigators will also perform a vastus~     lateralis muscle biopsy. Patients will then be randomized to receive either placebo (saline~     30 ml every 12 hours via the GI tract, EPA (1000 mg given every 12 hours via the GI tract),~     HMB (1500 mg given every 12 hours via the GI tract), or the combination of EPA (1000 mg given~     every 12 hours via the GI tract) and HMB (1500 mg given every 12 hours via the GI tract).~     Drugs will be given for 10 days; at the end of this time (on day 11), strength measurements,~     ultrasound muscle size measurements, and the vastus lateralis biopsy will be repeated. On day~     21 an additional followup set of diaphragm and quadriceps strength and size measurements will~     be made (the biopsy will not be repeated for this last set of measurements). Patients will be~     followed clinically and patient outcomes (mortality, duration of mechanical ventilation after~     study entry) will be recorded.~   "
175305|NCT01270503|"~     This aim of the study is to assess post-marketing safety of a single dose of Menactra®~     vaccine with the intent to support conversion from monitored release to initial registration~     of Menactra® vaccine in the Philippines.~      Primary Objective:~      To describe the serious adverse events occurring within 30 days among participants who have~     received one dose of Menactra® vaccine.~   "
175307|NCT01270477|"~     The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant~     treatment for frost damage.~      The investigators hope to include at least 20 patients in a randomized manner. Half of the~     patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to~     have hyperbaric oxygen treatment.~      Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as~     adjuvant treatment for frost damage. The functional level of the frost damaged patient is~     better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost~     damage.~   "
175308|NCT01270464|"~     The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or~     3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than~     placebo in improving lung function in patients with eosinophilic asthma as assessed by the~     overall change from baseline in forced expiratory volume in 1 second (FEV1).~   "
175309|NCT01270451|"~     Primary Outcomes:~        1. To study cross-sectional associations between diet, physical activity, T2DM and weight~          in subjects 2 yrs after surgery.~        2. To study if subjects receiving extra guidance in diet and physical activity experience~          less weight gain compared to a control group.~           Secondary Outcomes:~        3. To study the association between vit.D levels and T2DM.~        4. To study the association between weight change and QOL.~        5. To validate the new guidance strategy by recording food intake, energy expenditure and~          physical activity level.~        6. To study if subjects receiving extra guidance in diet and physical activity experience~          other health effects compared to a control group.~        7. To search for biomarkers that can identify people at risk of increasing weight post~          surgery~   "
175310|NCT01270438|"~     This phase II clinical trial is studying how well giving combination chemotherapy and~     bevacizumab with or without RO4929097 works in treating patients with metastatic colorectal~     cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It is not yet known whether combination chemotherapy and bevacizumab is more~     effective with RO4929097 in treating patients with colorectal cancer.~   "
175311|NCT01270425|"~     Systemic sclerosis (SSc) is a systemic disease that involves various organs such as the skin,~     kidneys, gastrointestinal tract and lungs. Dysfunction of the thyroid gland is prevalent in~     these patients and may be related to thyroid fibrosis or to thyroid autoimmune disease, i.e.~     hashimoto's thyroiditis. Thyroid nodules are prevalent in the general population, although~     some reports suggest they might be more frequent in patients with SSc. Hashimoto's~     thyroiditis, by itself, carries a higher risk for thyroid nodules and thyroid cancer.~      The aim of the study:To characterize sonographycally the thyroid gland of patients with SSc~     with and without Hashimoto's disease~   "
175312|NCT01270412|"~     Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in~     osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the effect~     of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the knee.~   "
175313|NCT01270399|"~     Lung cancer remains the most common cause of cancer-related death in the world. The major~     advances in treatment of lung cancer have brought only minor improvements in survival~     therefore novel systemic treatment methods are urgently needed.~      Protein levels are regulated by the protein homeostasis network that generates and protects~     the protein fold (ER and Golgi included).~      The heat shock protein 90 (Hsp90) is an essential molecular chaperon involved in the~     posttranslational folding and stability of proteins. Hsp90 inhibition leads to accumulation~     of unfolded proteins and ER stress. The therapeutic efficacy of such inhibition may be~     augmented by co-administering it with other drugs that disrupt ER-Golgi homeostasis like~     histone deacetylase (HDAC) or proteasome inhibitors. ER-Golgi homeostasis disruption affects~     a wide network of proteins and pathways as such affords a systemic target. Thus, the~     investigators aimed to examine the effect of combined treatment of Hsp90 antagonist with~     proteasome or HDAC inhibitors on human lung cancer cell lines and primary cells.~   "
175314|NCT01270386|"~     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor~     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests.~     Phase I study has shown that the drug's toxicity is manageable and the maximum tolerable~     daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve~     progression free survival compared with placebo in patients with advanced non-squamous and~     non-small cell lung cancer who failed two lines of chemotherapy.~   "
175315|NCT01270373|"~     The purpose of this study is to evaluate the usual and the reverse sequence of an~     anthracycline followed by a taxane in locally advanced breast cancer.~   "
175316|NCT01270360|"~     Screening campaigns for colorectal cancer (CRC) involve two steps: the detection of occult~     blood in stools using a Hemoccult GAIAC test (FOBT) on three consecutive stool samples,~     followed by colonoscopy if the result is positive. The information quality of the Hemoccult~     test, however, is poor: in the asymptomatic 50 to 74 year-old population, the detection~     sensitivity of polyps more than 1 cm in diameter is of the order of 10 to 30% and is 35 to~     50% for detecting colorectal cancers; specificity is 94 to 98% that of a complete~     colonoscopy. The I-FOBTs based on immunological detection and quantification of occult blood~     in stools are currently being evaluated; based on the threshold it can be more sensitive than~     FOBT, but enhances useless colonoscopies. Alternatively, with highest threshold of blood in~     stools, it may become highly specific and miss less advanced polyps. Faecal molecular tests~     based on the detection of human DNA anomalies (point gene mutations, methylation disorders of~     CG islets) appear to be more sensitive than the detection of occult blood in stools with no~     loss of specificity, but they are very expensive, thereby limiting their generalisation to~     the scale of population screening. A formal methylated DNA test has been validated in stools~     as well as in blood in a cohort of symptomatic individuals having undergone colonoscopy. The~     aim of the present study is to validate this test by taking advantage of the biotechnical~     expertise from renowned academic research teams and mass screening organisation.~   "
175317|NCT01270347|"~     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory~     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which~     has been particularly problematic to eradicate and been implicated as the major cause of~     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung~     increases the local concentrations of antibiotic at the site of infection resulting in~     improved antimicrobial effects compared to systemic administration. Bacterial resistance to~     current aerosol antibiotic treatments indicate a need for improved therapies to treat CF~     patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and~     other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to~     have antimicrobial effects on even the most resistant organisms.~   "
175318|NCT01270334|"~     vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally~     for missed abortions in the first trimester~   "
175319|NCT01270321|"~     The purpose of this study is to determine the effectiveness of two anticancer drugs,~     everolimus and pasireotide, in patients with thyroid cancer when the cancer is no longer~     responding to treatment with radioiodine or where it is deemed unsafe for the patient to~     receive additional radioiodine treatment. The investigators also want to establish the best~     manner of taking the two medications when used together to treat thyroid cancer. In~     particular, the investigators want to know if it is better to give both at the same time or~     add a second medication after the first one has stopped working.~      This study will also look at specific substances called biomarkers in your blood, and in the~     tumor tissue which are involved in the growth of tumor cells, and determine if the levels of~     these biomarkers are related to your response to treatment or development of side effects.~      Everolimus, also known by the brand name, Afinitor, is a biologic drug approved by the Food~     and Drug Administration (FDA) for the treatment of kidney cancer. It works by preventing~     cancer cells from multiplying and it also makes them more likely to die from the treatment.~      Pasireotide also known by the name, SOM230 is a new medication that is not yet approved by~     the FDA for the treatment of cancer. It is a newer form of a drug called octreotide, which is~     approved for the treatment of cancer arising from endocrine organs. Pasireotide works by~     binding to a protein called somatostatin receptor, which is expressed in many tissues~     throughout the body including thyroid cancer cells. Pasireotide prevents the action of~     somatostatin by binding to these receptors.~   "
175320|NCT01270308|"~     The objective of this study was to compare the relative bioavailability of Lansoprazole DR~     Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human~     subjects.~   "
175321|NCT01270295|"~     RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar~     epithelial type I cell injury. Soluble RAGE (sRAGE) is elevated in the plasma and in the~     pulmonary edema fluid from patients with ALI/ARDS, but one should acknowledge that the~     RAGE/NF-B axis is also involved in the pathophysiology of various other conditions. Few data~     are available about the levels of soluble forms and ligands of RAGE in the setting of~     ALI/ARDS. The purpose of this observational prospective study is to describe soluble forms~     (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients with~     ALI/ARDS.~   "
175322|NCT01270282|"~     The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic~     AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear~     tinnitus.~   "
175323|NCT01270269|"~     Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal~     cost to ICU survivors who frequently experience significant cognitive impairment and an array~     of physical and functional disabilities that limit their recovery and quality of life. While~     the problems experienced by these patients are likely amenable to rehabilitation, few ICU~     survivors receive focused rehabilitation. Recently, early physical rehabilitation in ICU~     patients has shown to improve the chances a patient will regain their pre-hospital functional~     status. Early cognitive rehabilitation for these patients has not yet been explored. This~     pilot study will determine the feasibility of early cognitive rehabilitation in ICU patients.~     The investigators will perform cognitive and physical rehabilitation, beginning in the~     earliest phases of critical illness, to determine the effect of these therapies on cognitive~     and functional outcomes in ICU survivors. The investigators hypothesize that combined~     cognitive and physical rehabilitation, started in the ICU, will improve recovery of cognitive~     and physical function as well as improve quality of life of ICU survivors.~   "
175324|NCT01270256|"~     The purpose of this study is to see if a nasal steroid drug delivered to the nose with the~     NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round~     allergy symptoms).~   "
175325|NCT01270243|"~     We, the investigators, propose to look at the bacteria on and in tonsils using gene~     microarrays. We expect to find previously reported bacteria but also the possibility of~     previously undetected organisms. We think that the bacterial pathogens present on the~     tonsillar surface are different from the tonsil core. And we also think that the bacteria of~     the tonsil surface will differ between patients undergoing adenotonsillectomy and normal~     controls with no adenotonsillar problems.~   "
175338|NCT01270074|"~     The general aim of this project is to conduct a randomized, double-blind, placebo-controlled~     clinical trial of azithromycin to determine whether treatment from infancy is safe and will~     prevent the onset of bronchiectasis. One hundred and thirty infants will be recruited from CF~     clinics in Australia and New Zealand and treated from 3 months to three years of age. The~     primary outcome will be the proportion with radiologically-defined bronchiectasis at 3 years~     of age. Safety and mechanistic evaluations will also be undertaken.~   "
175393|NCT01269359|"~     Modern orthopedic and spine surgeons strive towards minimizing surgical exposure and towards~     increased precision in the placement of implants. This trend requires an increased use of~     fluoroscopic guidance, which leads to increased exposure of the patient, surgeon and the~     operating room staff to radiation.~      Robotic assisted spine surgery is routinely performed in the authors' institution for a~     variety of indications such as degenerative conditions, trauma, tumors , infections and~     deformity correction11. The objective of this study is to compare the radiation exposure time~     during robotic guided vertebral body augmentation to the published results for similar~     surgeries.~   "
180806|NCT01198327|"~     This study evaluates long-term safety in patients with macular edema due to Retinal Vein~     Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in~     the HORIZON extension trial.~   "
175326|NCT01270230|"~     African American men who have sex with men and women (AAMSMW) are at particular risk for~     contracting and transmitting HIV, and represent a priority population for developing~     effective interventions. Despite the urgent need for effective prevention approaches for~     AAMSMW, to our knowledge no evidence-based HIV interventions have been developed and tested~     for this population. This study is a randomized controlled trial of the Bruthas Project(BP),~     an individual-level HIV prevention intervention, which builds on standardized HIV counseling~     and testing. Delivered in a series of four sessions by trained African American male~     counselors, the BP focuses on reviewing HIV transmission routes for male and female partners,~     strengthening sexual communication skills with both male and female partners, and improving~     condom use skills and other safer sex negotiation strategies. A randomized controlled trial~     of BP is necessary to determine the efficacy of the intervention and can lead to improved~     public health efforts at reducing HIV risk behavior among AAMSMW and in the African American~     community more generally. To evaluate the effect of the BP, the investigators will recruit~     and enroll a cohort of 400 AAMSMW who will be randomly assigned to either the intervention~     condition, in which they will be offered BP, or to the comparison condition, in which they~     will receive standardized HIV testing and counseling with referral to case management. The~     investigators will follow the cohort over 9 months and will assess participants at three time~     points: baseline, 3 months follow-up, and 6 months follow-up.~   "
175327|NCT01270217|"~     The purpose of this study is to determine whether brief motivational interviews reduce~     problematic drinking behavior among individuals arrested for the first time for driving under~     the influence of alcohol (DUI).~   "
175328|NCT01270204|"~     The purpose of this study is to evaluate the effect of taste on swallowing efficiency, to~     evaluate the effect of temperature on swallowing efficiency, and to evaluate the effect of~     viscosity on swallowing efficiency.~   "
175329|NCT01270191|"~     Whether GLP-1 and GLP-1 receptor agonists will produce a sustained improvement in beta-cell~     function following short-term therapy is currently not known. This randomized, controlled~     trial is carried to assess the efficacy of short-term insulin therapy (NPH injection twice~     daily) compared with GLP-1 analogue (Exenatide injection twice daily) on glycemic control,~     remission rate, ß-cell function, and long-term glycemic control in newly diagnosed type 2~     diabetic patients with moderate hyperglycemia.~   "
175330|NCT01270178|"~     Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in~     turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients~     who underwent curative therapy died from progressive liver decompensation rather than~     recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus~     (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical~     resection.~      This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B~     patients after receiving RFA therapy for HCC.~   "
175331|NCT01270165|"~     No study has reported on the comparative effect of continuing lamivudine plus adefovir versus~     switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic~     hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of~     this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching~     to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic~     hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12~     months.~   "
175332|NCT01270152|"~     The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally~     implanted central venous catheter~   "
175333|NCT01270139|"~     The investigators hypothesize that the nanoburning is very challenging technique to demolish~     and reverse the plaque especially in combination with stem cell technologies promising~     functional restoration of the vessel wall.~      The completed (in July 2012) interventional three arms (n=180) first-in-man trial (the~     NANOM-FIM trial) assessed (NCT01270139) the safety and feasibility of two delivery techniques~     for nanoparticles (NP), and plasmonic photothermal therapy (PPTT) of atherosclerotic lesions.~     Patients were assigned in a 1:1:1 ratio to receive either (1) nano-intervention with delivery~     of silica-gold NP in mini-surgery implanted bioengineered on-artery patch (n=60), or (2)~     nano-intervention with delivery of silica-gold iron-bearing NP with targeted micro-bubbles or~     stem cells in hands of magnetic navigation system (n=60) versus (3) stent implantation~     (n=60). The primary outcome was TAV at 12 months.~      The observational prospective cohort analysis (an amendment to the protocol of August 29th~     2012 with a decision to extend a 1-year study for another 4 years with the assessment of the~     5-year clinical outcomes both retro- and prospectively) of the long-term clinical outcomes at~     the intention-to-treat population of 180 patients with CAD and angiographic SYNTAX score ≤22~     enrolled initially to NANOM-FIM trial will be performed at 5 years after the intervention.~     The primary outcome will be a MACE-free survival. The secondary outcomes will be MACE,~     cardiac death, TLR (target lesion revascularization) and TVR (target vessel~     revascularization). Imaging endpoints will be assessed pre-, post- procedure and at 12-month~     follow-up. Clinical endpoints will be analyzed at the baseline and at 12 and 60-month~     follow-up (the release of results is expected after October 2016). Parameters of nanotoxicity~     will be assessed.~      The subset post-hoc analysis will be conducted at 1- and 5-year follow-up (by the Amendment~     of August 29th 2012). At the first subset patients underwent stenting with XIENCE V stent~     proximal to the site of nano-intervention (n=13). Subjects in the second subset were~     undergone drug-coated balloon pre-dilation with further nano-technique (n=20). Lesions in~     patients of the third subset were not prepared for the nano-approach (n=147) (neither~     stenting nor balloon angioplasty). The analysis will be performed and results will be~     released in 2017 with the same clinical outcomes.~      This project and related manuscripts were not prepared or funded in any part by a commercial~     organization. Nanoparticles and biomedical equipment were supplied free for the study by the~     non-profit Agiko and De Haar Foundation (Rotterdam, the Netherlands). All rights of the~     authors are reserved. The access of the international academic or governmental organizations~     to the essential and primary data of the trial is restricted by the Russian governmental~     authorities due to interest of the Russian Federal Security Service (FSB).~   "
175334|NCT01270126|"~     Non-invasive brain stimulation can increase cortical excitability in the visual system, but~     it is not known if this is of clinical value. The investigators now assessed if repetitive,~     transcranial alternating current stimulation (rtACS) can improve visual field size in~     patients with optic nerve damage. The investigators hypothesized that rtACS would improve~     visual functions within the defective visual field sectors of the visual field (primary~     outcome measure).~   "
175335|NCT01270113|"~     China faces the challenge of dual epidemics of drug use and HIV/AIDS. In responding to~     concerns of high rates of HIV/AIDS and other medical consequences among heroin users, China~     has recently implemented methadone maintenance treatment (MMT) programs nationwide. One~     problem noted with this rapid expansion is that the dropout rates from MMT have been high.~     The proposed study will adapt a motivational incentives (MI) intervention developed in the~     United States for use in Chinese MMT settings and will pilot test its effectiveness in~     improving treatment compliance and outcomes. The study's primary aims are: 1. to adapt a~     motivational incentives intervention in MMT in China, and 2. to experimentally pilot test the~     motivational incentives intervention. A secondary aim is to explore factors that may~     influence the outcomes of MMT that incorporates a motivational incentives intervention. It is~     hypothesized that the MI intervention can be adapted to Chinese settings and that it will~     optimize the positive outcomes of MMT in reducing HIV risks among heroin abusers. The~     collaborative team includes researchers in American and Chinese institutes (UCLA/Johns~     Hopkins/Washington, Shanghai Mental Health Center, Yunnan Institute for Drug Abuse),~     officials from national and local Chinese Centers for Disease Control and Prevention, and~     providers in local MMT clinics in Shanghai and Yunnan.~   "
175336|NCT01270100|"~     The purpose of the study is to develop and pilot-test a Recovery Management Intervention~     (RMI) program for heroin addicts released from compulsory rehabilitation in China.~      The project has the following specific aims:~      Primary aims:~      Aim 1. To engage key stakeholders in the local communities involved in supporting the~     transition of heroin addicts released from compulsory rehabilitation to the community; Aim 2.~     To identify potential barriers for participating in MMT in China; Aim 3. To develop and~     deliver educational/training materials on HIV risks, relapse prevention, and MMT; Aim 4. To~     adapt and develop the Recovery Management Intervention (RMI) program for heroin addicts~     released from compulsory rehabilitation in China; Aim 5. To conduct a pilot trial and obtain~     preliminary outcome data associated with RMI, relative to enhanced standard care.~      Secondary aim:~      Aim 6. To explore predictors of relapse and HIV/AIDS risk behaviors.~      It is hypothesized that the intervention will reduce drug use relapse and the negative~     consequences associated with relapse, including HIV risk behaviors~   "
175339|NCT01270061|"~     Project Wellness is a new intervention that combines the use of culturally-sensitive,~     video-based education, a general health screening approach, and a community pharmacy setting~     into one program to improve black African immigrant participation in voluntary HIV testing.~     The study is divided into three phases: qualitative research; video production; and a~     feasibility trial. In Phase 1, the investigators will conduct in-depth interviews and focus~     group discussions with black African participants to obtain insights on overlapping and~     resonating themes that will help increase participation in HIV testing among black Africans~     in the Bronx. In Phase 2, data obtained through qualitative work will guide the development~     of four health education videos. A culturally-tailored educational video on diabetes,~     hypertension, and HIV will be developed and produced for each gender and in both English and~     French. In phase 3, the investigators will test the feasibility of a pharmacy-based,~     culturally-tailored, general health screen that includes rapid HIV testing. The trial will~     help determine the feasibility of using a computer-based model; recruitment of black Africans~     in the pharmacies; acceptance of testing; and linking individuals diagnosed with health~     problems into medical care. A secondary analysis will also determine predictors of refusing~     to be tested.~   "
175340|NCT01270048|"~     The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort~     of Hwa-byung's major symptom and develope and establish pattern identification system in~     Hwa-byung.~   "
175341|NCT01270035|"~     In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg~     every other week when used in combination with methotrexate (MTX) for patients with~     rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients,~     especially for those with high disease activity. Therefore, we tried to increase the ADA dose~     to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease~     below moderate activity defined by DAS28 < 3.2. The primary endpoint was the rate of patients~     who achieved disease remission (DAS28 < 2.6) at 30 weeks with this predifined treatment~     strategy.~   "
175342|NCT01270022|"~     The aim of this study is to evaluate the impact of a clinical guideline in cardiovascular~     risk, with a local adaptation model of the existing guidelines in clinical practise at~     present, of each of the different cardiovascular risk factors, and the implementation~     strategy.~   "
175343|NCT01270009|"~     MM accounts for 10% of hematopoietic malignancies. Despite the use of various drug~     combinations in chemotherapy, life expectancy of MM patients does not exceed 7 years. Until~     now, lack of specific markers of the disease has not allowed efficient specific molecular~     targeting. In view of our preliminary results, the antiapoptotic protein Bcl-B could be a~     novel diagnostic and pronostic marker of MM. Therefore, our main objective will be to confirm~     that Bcl-B is indeed a novel diagnostic and pronostic marker and a new potential therapeutic~     target of MM. Targeting Bcl-2 family member's is a promising strategy for the treatment of~     hematopoietic malignancies. In this context, specific targeting of Bcl-B could improve the~     treatment of patients suffering MM. Of note, this could be achieved by converting the~     antiapoptotic function of Bcl-B to a proapoptotic one thanks to the use of small mimetic~     peptides derived from Nur77 one of its interactors.~   "
175344|NCT01269996|"~     To evaluate the efficacy and safety of a new treatment regimen of metformin plus sitagliptin~     (Janumet) followed by a long-acting basal insulin (Lantus) treatment compared to the usual~     treatment regimen of metformin followed by sulfonylurea and intermediate-acting basal insulin~     in Type 2 Diabetes Mellitus patients.~   "
175345|NCT01269983|"~     The purpose is to evaluate the effectiveness of a physiotherapy program for chronic low back~     pain. We'll randomize more about 35 patients in two groups. Both groups will receive an 8~     physioterapy intervention in 4 weeks, in particular the first group (study) will receive 4~     Fascial Manipulation treatment combined with 4 session of a standard approach (mobilization~     and stretching exercises); whereas the second (control) will receive only the standard~     approach.~   "
175346|NCT01269970|"~     Early metabolic response evaluation may predict clinical and histopathological response after~     neoadjuvant chemotherapy. Its value in neoadjuvant chemoradiotherapy (CRT) is unknown. Our~     aim was to assess the value of early metabolic response after one cycle of chemotherapy using~     18-FDG-PET-CT to predict pathological response and outcome in cT2-4 N0/+ esophageal cancer~     treated by neoadjuvant CRT and esophagectomy.~   "
175347|NCT01269957|"~     Objective: determine whether there is a correlation between halitosis and mouth breathing in~     children. Study design: Fifty-five children between three and 14 years of age were divided~     into two groups (nasal and mouth breathing) for the assessment of halitosis. Descriptive~     analysis was carried out regarding the degree of halitosis in each group. The chi-square test~     was used for the comparison between groups, with 5% level of significance.~   "
175348|NCT01269944|"~     Medial compartment osteoarthritis of the knee is commonly treated by a surgical intervention~     called 'high tibial osteotomy' (VTO). Although it has repeatedly been shown that pain~     improves following this procedure, it is unknown how cartilage quality is affected by the~     procedure. In this study, a recently developed MRI technique is used to evaluate changes in~     cartilage quality before and after the surgery. Changes in MRI signals are correlated to~     subjective improvements (score lists). 10 patients participate in this study. Approval has~     been granted by the Medical Ethical Committee of the University Medical Center Utrecht. All~     participants are required to give informed consent before participation.~   "
175359|NCT01269801|"~     The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC, and~     BOTOX Cosmetic, work compared to each other and when used together for the cosmetic treatment~     of age-associated wrinkles and folds of the face.~   "
175394|NCT01269346|"~     This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin~     mesylate in combination with trastuzumab as first line treatment in female subjects with~     locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive breast~     cancer.~   "
175449|NCT01268631|"~     Hypothesis:~      Response to therapy in fibromyalgia can be improved by coupling of specific medications to~     the individual patterns of dysfunctional pain modulation. Individuals exhibit wide range of~     pain modulating capabilities that can be assessed by dynamic psychophysical testing. Those~     that exhibit less efficient endogenous analgesia and/or increased pain summation are known to~     be more prone to suffer from pain. Tailoring medications to compensate for the specific~     dysfunctioning modulatory mechanism will improve pain control.~   "
175349|NCT01269931|"~     Bronchoscopy is a procedure whereby a small flexible camera is used to inspect and biopsy~     abnormalities in the lungs. Linear endobronchial ultrasound with transbronchial needle~     aspiration (EBUS-TBNA) is a revolutionary diagnostic pulmonary procedure that allows~     visualization and safe, accurate biopsies of structures in and around the lungs during~     bronchoscopy. EBUS-TBNA can be challenging to learn.~      Historically, bronchoscopy has been taught using an apprenticeship model, whereby trainees~     practice on patients. With the introduction of computer bronchoscopy simulators, trainees can~     now obtain basic bronchoscopy skills by practicing on the simulator, rather than practicing~     on patients.~      This study aims to compare trainee EBUS-TBNA performance during actual procedures on~     patients, following training with a computer EBUS-TBNA simulator versus conventional clinical~     EBUS-TBNA training (trainees taught by practicing on patients). Our hypothesis is that the~     skills learned using a computer EBUS-TBNA simulator are transferable to clinical EBUS-TBNA~     performance, meaning that using a computer EBUS-TBNA simulator for training is just as good~     as learning these skills by practicing on patients.~      The use of EBUS-TBNA simulators for training could have the advantage of minimizing the~     burden of procedural learning on patients.~   "
175350|NCT01269918|"~     This will be a randomized blinded clinical trial. Patients will be randomized to receive~     either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team~     will know the result of randomization at induction. Data will be gathered by research~     personnel who will be blinded to the anesthetic method used. Patients will be blinded to the~     anesthetic they receive till they are discharged from the PACU when they will have the option~     to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse~     events and toxicity reports as well as annual reviews.~   "
175351|NCT01269905|"~     The optimal valve substitute for patients between 60-70 years is controversial. We compared~     anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve~     replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the~     risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not~     requiring permanent anticoagulation.~   "
175352|NCT01269892|"~     The purpose of this study is to determine which nutritional regime is better for acute~     diarrhea in outcomes.~   "
175353|NCT01269879|"~     A number of different therapeutic approaches to treat lateral epicondylitis have been tested~     partly in randomized trials, such as polidocanol sclerosing injections, botulinom toxin A~     injections, braces, surgery and topical NO patches.~      One study indicates that patients with lateral epicondylitis (lateral elbow tendinopathy)~     have poorer elbow proprioception in contrast to healthy controls (Juul-Kristensen B, et al.,~     J Shoulder Elbow Surg 2008;17(1 Suppl):72S-81S.)~      Based on a suggested poorer elbow proprioception in lateral elbow tendinopathy, The~     investigators hypothesize that a dedicated proprioceptive intervention might be able to~     reduce pain and improve function.~      As such a RCT is planned with two intervention arms with proprioceptive training using the~     Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk)~     over twelve weeks.~   "
175354|NCT01269866|"~     The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain~     severity in patient with Systemic Lupus Erythematosus.~   "
175355|NCT01269853|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic~     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of~     tumors also exhibits the most aggressive behavior, resulting in median overall survival~     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of~     either surgical resection, external beam radiation or both. All patients experience a~     recurrence after first-line therapy, so improvements in both first-line and salvage therapy~     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently~     used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators~     have shown in a previous phase I trial that a single Super-selective Intraarterial Cerebral~     Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of~     recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that~     trial in that the investigators seek to test the hypothesis that repeated dosing of~     intraarterial Bevacizumab is safe and effective in the treatment of recurrent malignant~     glioma. By achieving the aims of this study the investigators will also determine if IV~     therapy with Bevacizumab should be combined with repeated selected intraarterial Bevacizumab~     to improve progression free and overall survival. The investigators expect that this project~     will provide important information regarding the utility of repeated SIACI Bevacizumab~     therapy for malignant glioma, and may alter the way these drugs are delivered to the patients~     in the near future.~   "
175356|NCT01269840|"~     In severe injuries of the radial head with multiple, displaced fracture fragments and~     concomitant ligament damage, excision of the fragments and replacement of the radial head~     with a metallic implant are indicated. Current radial head implants are composed of metal or~     a combination of metal and high molecular weight polyethylene. The prostheses are assembled~     intra-operatively as a solid unit (monopolar) or as an articulating implant with motion~     between the stem and head (bi-polar). The stem of the implant is inserted into the proximal~     radius for support and can be classified as either loose-fitting or fixed. According to the~     investigators, there are no studies that directly compare the clinical and radiographic~     outcomes between different radial head implant designs. The purpose of this retrospective~     study is to compare the clinical and radiographic results in patients treated for an~     irreparable radial head fracture with either a smooth stem, bipolar radial head implant or a~     monopolar, in-growth radial head implant. The study findings may provide useful clinical~     information regarding the similarities and differences in these two implant designs.~   "
175357|NCT01269827|"~     The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of~     TNF-α, IL-6, and CRP in patients on hemodialysis.~   "
175358|NCT01269814|"~     The patients who admit to emergency department with upper gastrointestinal system bleeding~     will undergo a clinical evaluation with Rockall Risk Scoring System. The patients with~     Rockall score of 1 or less will be discharged with medical treatment, and will have an~     elective upper gastrointestinal endoscopy in the end of the 30th day. The impact of Rockall~     Risk Scoring System on assessing the necessity of emergency endoscopy, length of hospital~     stay, morbidity, and mortality in low-risk patients will be evaluated.~   "
175360|NCT01269788|"~     Gastro-esophageal reflux disease (GERD) is highly prevalent, affecting up to 20% of the adult~     population in North America. Up to 70% of GERD patients have non-erosive reflux disease~     (NERD), a term used to describe symptoms suggestive of GERD in patients with no endoscopic~     evidence of erosive esophagitis. NERD represents a heterogeneous group of patients whom are~     sub classified according to 24 hours-PH monitoring results and also symptom-acid association~     analysis(Symptom Index,SI).~      Treatment of NERD can be a challenge for clinicians. According to the many studies , the~     pooled rate for symptomatic response after a period of proton pomp inhibitor(PPIs)therapy as~     the most frequently used drug, in NERD patients is lower than for erosive esophagitis~     patients. It is also shown that acid exposure is much lower in NERD patients than those with~     erosive esophagitis and NERD patients are less likely to exhibit a strong association between~     heartburn symptoms and acid reflux events than patients with erosive oesophagitis.~      Furthermore, beside the high economic burden, there are concerns about the adverse effects of~     long time administration of PPIs.~      Several hypothesis has been proposed to describe low response rate of NERD patients to PPIs.~     One of the most acceptable theories is that patients with anxiety or depression and~     psychological problems are at an increased risk of developing reflux symptoms. On the other~     hand, pain modulators such as sertraline, a selective serotonin reuptake inhibitor(SSRI), and~     other antidepressants have been shown to improve symptoms in patients with functional~     gastrointestinal disorders like non cardiac chest pain.~      According to the above-mentioned tips, the investigators hypothesize that antidepressants~     like fluoxetine, as an SSRI, may have beneficial effects in improving symptoms of NERD~     patients.~      The purpose of this study is to compare the effect of omeprazole with fluoxetine and placebo~     for treatment of NERD patients and its subgroups who all experience reflux symptoms and have~     normal endoscopic findings.~   "
175361|NCT01269775|"~     The investigators carried out a randomized controlled trial comparing three methods of~     teaching. These three instructional methods consist of face to face lecture, interactive~     internet based teaching and computer based teaching (lecture synchronized with presentation).~      The hypotheses tested were: a) whether there is a difference between these three methods in~     knowledge achievement and b) whether there is a difference between Students satisfaction in~     three groups.~   "
175362|NCT01269762|"~     Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a~     significant cholesterol lowering effect which might be caused by addictive and/or synergistic~     effects of lovastatin (monacolin K) with other monacolins and substances in capsules. The~     usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is one capsule~     twice/day.~      However, the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte)is still~     unknown.~      The objective of the study is to evaluate the pharmacokinetic profile of red yeast rice~     capsule (LipoCol Forte) after administering single and multiple dose to healthy subjects.~   "
175363|NCT01269749|"~     The investigators hypothesize that 131I is an effective therapy for children with Graves'~     Disease (GD) and will not be associated with long-term cancer risks when used in older~     children, but may be associated with excessive levels of whole body radiation in young~     children. To address issues of 131I safety and cancer risk in the pediatric population, the~     investigators propose to: (1) Perform dosimetry to assess whole body radiation exposure~     following 131I therapy in children treated for GD (2) the investigators will assess~     chromosome translocation as related to age and dose of 131I.~      It is anticipated that these studies will provide new insights into RIA use in children and~     provide important information about radiation exposure associated 131I use in children. As~     such, these studies are expected to result in new recommendations for 131I use in the~     treatment of pediatric GD.~      Funding Source - FDA OOPD~   "
175364|NCT01269736|"~     The purpose of this study is to test the effect of implementing new practice standards for~     electrocardiographic (ECG) monitoring on nurses' knowledge and skills, quality of care, and~     patient outcomes. The investigators hypothesize that increased knowledge and skills of nurses~     will lead to enhanced quality of care, which will result in improved outcomes for patients.~   "
175365|NCT01269723|"~     Vegetables such as broccoli, cauliflower, kale and cabbage are particularly rich in a plant~     chemical called sulforaphane (SFN) which boosts production of certain defense enzymes that~     increase the activity of antioxidants. In animals, the chemical protection from SFN helps~     prevent diseases associated with inflammation and cancer among others, and this is currently~     being studied in humans.~      Young broccoli sprouts have a particularly high level of SFN compared to other foods. The~     purpose of this research study is to learn about short term responses to live attenuated~     influenza virus (LAIV, administered to you via Flumist® vaccine) between smoking and~     nonsmoking volunteers treated with broccoli sprout homogenates (shake) or a placebo~     homogenate. This will be done by obtaining a series of nasal lavages or rinses of your nose~     with salt water, as well as 3 superficial biopsies of the inside lining of your nose both~     before and after you receive the vaccine. Using these samples, we will measure the amount of~     virus and the amount of inflammation in your nose and compare how smokers and nonsmokers~     respond to the vaccine when they are given a broccoli sprout homogenate (high in SFN) or a~     placebo alfalfa spout shake which is low in SFN during each of 4 study visits.~      Subjects will be seen for a screening visit (inc. HIV test) and then randomly assigned to~     receive 1 of 2 homogenates. Broccoli sprout homogenate will be the the active treatment arm~     while the placebo arm will be alfalfa sprout homogenate. Two to 4 weeks after screening,~     subjects will return for 5 sequential visits (Monday-Friday). Monday-Thursday they will~     receive the assigned homogenate. On Tuesday, they will receive the Flumist®vaccine. Subjects~     will also be seen at 1 and 3 weeks post vaccine. Nasal lavage (NL), blood samples and nasal~     biopsies will performed prior to and after study interventions.~   "
175366|NCT01269710|"~     The purpose of this study is to get a better understanding of the side effect burden and~     identify predictors of psychotic, mood and aggressive disorders in children and adolescents.~     The study's primary aim is to identify genetic risk factors for weight gain and metabolic~     abnormalities.~   "
175367|NCT01269697|"~     Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina~     (named macula) and is the leading cause of blindness in industrialized countries. There is~     growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin)~     of dietary origin, which specifically accumulate in the macula, where they form the macular~     pigment. A first step towards the demonstration of a preventive effect of macular pigment for~     AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on~     their plasma and retinal concentrations.~   "
175368|NCT01269684|"~     The purpose of this study is to investigate safety and tolerability of an immediate~     conversion from Tacrolimus to everolimus in stable renal allograft recipients.~      Interest in developing CNI-free regimens using other agents such as the proliferation signal~     inhibitor everolimus.~   "
175369|NCT01269671|"~     IND application was submitted to FDA on November 17th.~   "
175370|NCT01269658|"~     The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic~     solution, 1% versus vehicle over a four-week treatment period in treating the signs and~     symptoms of subjects with blepharitis and to evaluate the clinical course of the condition~     under study.~   "
175392|NCT01269372|"~     This pilot, multi center study will establish the effectiveness of Given PillCam® Platform~     with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with~     polyps, compared to standard colonoscopy.~      This study will also use to evaluate the administrative feasibility and data management of~     study design.~   "
175371|NCT01269645|"~     The primary objective of this project is to examine the impact of providing cancer patients~     with audiovisual information about clinical trials on attitudes towards clinical trial~     participation. It is hypothesized that patients provided these materials will have more~     favorable attitudes toward clinical trial participation compared to patients not provided~     these materials.~      Participants will be randomized to either: (1) an intervention condition in which they will~     be asked to view a short video and read an accompanying brochure about clinical trials~     developed by the investigative team; or (2) a control condition in which they will be asked~     to read the National Cancer Institute's brochure entitled Taking Part in Cancer Treatment~     Research Studies. Self-report data will be collected at two timepoints: 1) in person~     following study enrollment, but before receipt of material related to intervention assignment~     (baseline/Time 1), and 2) by telephone interview between 7 and 28 days following study~     enrollment (follow-up/Time 2). In addition, data will also be collected from medical records~     six weeks after study enrollment.~   "
175372|NCT01269632|"~     Background: With the improvement of the prognosis for HIV-infected infants, thanks to the~     availability of antiretroviral therapies, young adults infected with HIV since birth are~     becoming an emerging group among the HIV-infected population. Morbidity, mortality and~     immunovirological evolution in these young adults need to be studied in a large population~     and compared to patients infected with HIV later in adulthood or to the general population in~     terms of mortality. Moreover, the study of accelerated or premature ageing, linked to HIV~     and/or antiretroviral therapy, is particularly interesting in this population.~      Objectives: To study the transition to adulthood and the further evolution of HIV-1 or -2~     perinatally infected young adults: 1) To study the teenager to adult transition in terms of~     clinical and immunovirological status, schooling and professional integration, sexuality and~     reproductive life, transition from paediatrics to adult departments; 2) To study prognosis,~     morbidity and mortality according to age, infection stage at the time of antiretroviral~     initiation and therapeutic history; 3) To study the incidence and expression of adverse~     events and the potential link to antiretroviral therapies; 4) To study the markers of a~     potential premature ageing, from the metabolic, cardiovascular and immunological points of~     view.~   "
175373|NCT01269619|"~     Lower back pain is one of the most common conditions affecting humans. Lower back supports~     are a common device used in order to alleviate the pain. All the available back supports are~     wrapped around the lower back and abdomen and act as static support devices. The hug is a~     new dynamic back support where the participant actively improves his/her posture and~     strengthens the muscle of the lower back. This trial compares both devices and their effect~     on reducing lower back pain.~   "
175374|NCT01269606|"~     This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at~     which rate the body eliminates the substance from the body) of insulin aspart with~     fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection~     in Japanese subjects with type 1 diabetes mellitus.~   "
175375|NCT01269593|"~     The purpose of this study is to see how a new drug, named PUH71, accumulates in the different~     parts of the body & inside tumors and how long PUH71 lasts in the blood, when given to study~     participants in tiny amounts. The results of this study will help researchers (1) plan how~     they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of~     cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting~     tumors with scanner machines.~   "
175376|NCT01269580|"~     Type of Study: Pilot Study monocenter Study Duration: 18 months Subject Participation~     Duration: The patients are enrolled for the time of the blood withdrawl.~      Follow up visit will be after 12 months from the enrollement.~      Objectives:~      The project will have two major objectives:~      A)To validate the prognostic value of vascular progenitor cells, identified by flow~     cytometric analysis of antigenic phenotype, in a cohort of 109 patients with type-2 diabetes~     complicated by ischemic foot ulcers. Events are: cardiovascular mortality, major amputation,~     post-angioplasty restenosis , and development of new atherosclerotic plaques in treated limb~     B)To determine the mechanisms responsible for vascular progenitor cell dysfunction in the~     perspective of new therapies for the cure of the diabetic foot.~   "
175377|NCT01269567|"~     After rectal excision, the rate of anastomotic leak and abscess is higher than after colic~     surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a~     prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness~     of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice~     had never been evaluated in patients with rectal excision and low anastomosis (patients with~     a high risk of pelvic sepsis)~   "
175378|NCT01269554|"~     Diarrhoea is the leading cause of death in the world with 2.2 million deaths every year. The~     majority of deaths are among children in developing countries, but the travellers encounter~     the disease as well. The studies on the aetiology have suffered from serious methodological~     deficiencies and the results are even controversial. At the same time, the current diagnostic~     methods are inadequate. The investigators have recently developed novel multiplex RT-PCR~     methods to cover the majority of diarrhoeal pathogens. The present study is a collaboration~     between Finland and Sweden/Guinea-Bissau. The aim is to characterize the causative agents of~     diarrhoea (a) in Finnish volunteers before and after a travel to tropical areas and, (b) in~     inhabitants of endemic areas in Guinea-Bissau. For these purposes stool samples will be~     collected from volunteers of different age groups and from healthy volunteers as well as~     those with diarrhea both in Guinea-Bissau and in Finland. In addition to pathogens, other~     intestinal microbes and antimicrobial resistance will be investigated~   "
175379|NCT01269541|"~     The purpose of this study is to determine whether systemic antibiotic treatment with~     rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with~     mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers~   "
175409|NCT01269151|"~     Multifocal-electroretinoram (ERG) and microperimetry are objective criteria to asses retinal~     function. No information besides visual acuity exist for the development of retinal function~     during the course of wet AMD during therapy with Lucentis. The aim of our study is to~     evaluate the value of multifocal-ERG and microperimetry as an sensitive tool and early~     predictor of recurrence of the disease. The second goal will be to evaluate the~     neuroprotective effects of an adequate therapy on retinal function using microperimetry and~     multifocal-ERG during the course of wet AMD.~   "
175380|NCT01269528|"~     Protocol Synopsis: There is a link between early RSV infection and chronic respiratory~     morbidity.~      Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory~     morbidity.~      Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity~     (AHR) in children born at 29-32 weeks.~      Secondary objective: to assess prospectively the effect of palivizumab on respiratory~     morbidity airway inflammation and allergy in children born at 29-32 weeks.~      Inclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.~      Exclusion criteria: Any mechanical ventilation or chronic diseases, e.g., bronchopulmonary~     dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known~     immunodeficiency, or receipt of other RSV investigative vaccines or therapies.~      Primary end points: Airway reactivity as assessed by methacholine challenge test with~     determination of PC20.~      Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone~     interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.~      Sample size: 74 participants; Group I - 37 premature babies at 29-32 weeks of gestation born~     during 2007-2008 (before approval of Synagis for this group in Israel). Group II - 37~     premature babies 29-32 weeks of gestation born during 2009-2010 (after approval of Synagis~     for this group in Israel).~      Statistics: A sample size of 37 patients was calculated as necessary to detect a difference~     of 0.5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline~     characteristics will be compared using 1-way analysis of variance for quantitative variables~     and Fisher's exact test for categorical variables.~   "
175381|NCT01269515|"~     Chronic immune activation is a central feature of HIV-infection, and the degree of activated~     T-cells is a better predictor of disease progression and mortality than plasma viral load.~     The study hypothesis is that the anti-inflammatory substance etoricoxib will dampen chronic~     immune activation and improve the effect of T-cell dependent vaccines in HIV-1 infected~     patients.~      The aim of the present study is to explore the efficacy of the study drug on markers of~     immune activation and vaccine responses, as well as safety of the study drug, in HIV-infected~     patients not receiving antiretroviral therapy and in patients on long-term effective ART who~     had CD4 counts < 500.~   "
175382|NCT01269502|"~     A randomised controlled pilot study on the feasibility of introducing a skin temperature~     device (Temp Touch) in secondary prevention of foot ulcers in people with diabetes who have~     had a foot ulcer in Norway.~   "
175383|NCT01269489|"~     The purpose of the study is to obtain reference data on health-related quality of life for~     the functional and symptom scales and single items of the European Organisation for Research~     and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ C30) in a~     representative sample of Slovenian general population.~   "
175384|NCT01269476|"~     This is a randomised, double-blind, group-sequential, placebo-controlled, safety and~     pharmacokinetic study in healthy, aged volunteers.~      Objectives:~        1. to confirm the previously reported safety profile of oral SNX-001 after single and~          multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo~        2. to establish SNX-001 pharmacokinetic profile.~   "
175385|NCT01269463|"~     The time course of response following one dose of a new methylphenidate hydrochloride~     extended release capsule is studied in children 6-12 years in a simulated laboratory~     classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been~     formulated for daily dosing to provide treatment of a child with ADHD for the substantial~     day.~   "
175386|NCT01269450|"~     Working hypothesis and aims:~      To investigate whether progesterone treatment affects the incidence of preterm labor compared~     to placebo, among women with 2nd trimester bleeding.~      The participants will be allocated through randomization to a study or control group. Women~     in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an~     intra-vaginal tablet once daily while the control group will receive placebo. Both women and~     medical staff will be blinded to group allocation. Treatment will commence on the day of~     inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation.~     Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal~     outcome.~   "
175387|NCT01269437|"~     This is an open-label, randomized, parallel Group, multicenter study to evaluate the efficacy~     and safety of budesonide novolizer dry powder inhaler compared with budesonide turbuhaler dry~     powder inhaler in Chinese mild to moderate asthma patients.~   "
175388|NCT01269424|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     O6-benzylguanine may help temozolomide work better by making tumor cells more sensitive to~     the drug. Giving genetically modified peripheral blood stem cells during or after treatment~     may prevent side effects caused by chemotherapy.~      PURPOSE: This clinical trial studies O6-benzylguanine and temozolomide in combination with~     genetically modified peripheral blood stem cells in treating patients with newly diagnosed~     glioblastoma multiforme.~   "
175389|NCT01269411|"~     This phase I trial is studying the side effects and best dose of RO4929097 in treating~     patients with recurrent invasive gliomas. RO4929097 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth~   "
175390|NCT01269398|"~     Utilization of trans-pedicular trans-discal implants for stabilization of a single lumbar~     motion segment, in conjunction with posterior facets fusion. The trajectories are planned and~     achieved by means of the SpineAssist® system - a computerized, image-based guidance system~     that assists surgeons in precisely guiding spinal surgical tools and implants in line with a~     CT-based pre-operative plan. GO-LIF and SpineAssist are CE marked products.~      Thy study's objective is to to collect data regarding the ability to achieve solide fusion,~     comibing the GO-LIF procedure for spinal fixation and stabilization with percutaneous~     posterior facets fusion.~   "
175391|NCT01269385|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can kill chronic~     lymphocytic leukemia (CLL) cells and are effective therapies for this disease. Biological~     therapies, such as Imprime PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose), may~     stimulate the immune system in different ways and help monoclonal antibodies kill CLL cells.~     Giving PGG beta-glucan together with alemtuzumab and rituximab could make therapy with~     monoclonal antibodies, such as alemtuzumab and rituximab, more effective.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of PGG beta-glucan~     when given together with alemtuzumab and rituximab and to see how well it works in treating~     patients with earlier stage high-risk chronic lymphocytic leukemia.~   "
175395|NCT01269333|"~     Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute~     coronary events and coronary interventions. Several studies have shown that some patients are~     resistant to clopidogrel. The resistance mechanism is not entirely clear yet, but at least in~     part it is related to interactions between medications.~      Omeprazole is a member in the family of gastric proton pump inhibitor (PPI) that are widely~     used in patients who receive combination of aspirin and clopidogrel in order to protect the~     stomach lining and prevent GI bleeding. Data from studies on platelet aggregation indicate~     that treatment with omeprazole may cause partial resistance to clopidogrel and increase risk~     for recurrent cardiovascular events in patients after coronary interventions. Recently the~     FDA published struck to avoid cross clopidogrel and omeprazole treatment for fear of~     reduction efficiency. Nevertheless there are several studies that do not support increased~     risk of cardiovascular events among patients taking omeprazole and clopidogrel, as the COGENT~     trial which is the single prospective controlled study that assessed the clinical implication~     of this drugs interaction.~      The accepted Mechanism of interaction between omeprazole and clopidogrel is disturbance to~     create clopidogrel active metabolite through CYP2C19 inhibition by omeprazole. fluvoxamine -~     is a member in SSRIs family and a potent inhibitor of the CYP2C19. In vivo studies compared~     the degree of decomposition proguanil (a CYP2C19 indicator) by fluvoxamine and omeprazole~     found constant inhibition- Ki = 10 Micromol / L for of Omeprazole versus constant inhibition-~     Ki = 0.69 Micromol / L for fluvoxamine. This indicates a more potent inhibition of CYP2C19 in~     vivo of fluvoxamine compared to omeprazole. It is important to note that so far there is no~     date in literature studies demonstrates that there is any interaction between fluvoxamine and~     other CYP2C19 inhibitors and Clopidogrel.~      Research goals:~        -  To assess the impact of fluvoxamine and omeprazole on platelet reactivity in healthy~          individuals treated with clopidogrel.~        -  To verify weather the mechanism of omeprazole-clopidogrel interaction is related to~          CYP2C19 inhibition.~      Study design:~      Randomized blinded placebo-controlled crossover trial on healthy volunteers. The response to~     clopidogrel will be assessed using two methods in subjects receiving clopidogrel and one of~     the study drugs: fluvoxamine, omeprazole or placebo.~   "
175396|NCT01269320|"~     This is a Single -arm, open-label, before-and after exploratory trial of 90 days of Femarelle~     ® to improve NAFLD and the metabolic syndrome.~      Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome~     in patients suffering from these conditions.~      Subjects will receive treatment with Femarele 530 mg (1 capsule twice a day) for 90 days and~     will then be monitored off study treatment for an additional 4 weeks.~   "
175397|NCT01269307|"~     The purpose of this study is to determine if procedural sedation utilizing a 1:1 mixture of~     propofol and ketamine is equivalent in complications, patient and physician satisfaction,~     post-procedure pain level, and procedural outcome to propofol sedation alone.~   "
175398|NCT01269294|"~     The purpose of this study is to evaluate the effect of TMC435 on the results of~     electrocardiograms (ECGs) in healthy volunteers. An electrocardiogram is an electric~     recording of the heart. TMC435 is being investigated for the treatment of chronic hepatitis C~     virus infection.~   "
175399|NCT01269281|"~     The objective of this study was to compare the relative bioavailability of Sumatriptan~     Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult~     human subjects.~   "
175400|NCT01269268|"~     There was no sensitive and specific biomarker for tuberculosis infection, disease progression~     and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate~     and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new~     biomarker for TB infection, the investigators will recruit the participants including active~     TB patients, healthy household contacts, healthy community control.~   "
175401|NCT01269255|"~     A Phase I trial of Induction chemotherapy and Chemoradiotherapy with TS-1 and Cisplatin (SP)~     as first-line treatment in patients with high risk advanced gastric cancer. Drugs used in~     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Radiation therapy was effectively used in~     esophageal cancer, laryngeal cancer and rectal cancer, but gastric cancer are rarely studied~     in Korea. There is an increasing interest in preoperative radiotherapy in effort to improve~     survival and increase pathologic complete response in patients with gastric cancer.~     Chemoradiotherapy may be the best modality in the neoadjuvant setting for high-risk advanced~     tumors, such as type IV or large type III, N3/bulky N2 metastasis, or locally advanced~     tumors.~   "
175402|NCT01269242|"~     The main study objective is to assess the efficacy and safety of different bindarit dosages~     compared to placebo in preventing restenosis, in patients submitted to coronary stenting and~     using a bare metal stent (Vision BMS, by Abbott).~   "
175403|NCT01269229|"~     The purpose of this study is the increase of resection rate of primary cancer in rectal after~     short course radiotherapy without interrupt chemotherapy schedule during the period of~     chemotherapy. The subject should have the pathologically confirmed for unresectable~     (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.~      This trial contributes to save the time for decreasing primary tumor in rectal and metastasis~     cancer to whole body after short course radiotherapy.~   "
175404|NCT01269216|"~     This is an open-label, randomized phase II study. Patients will be randomly assigned to~     either FL or TS-1/irinotecan preoperative chemotherapy regimens by stratification. Patients~     in FL group will be treated with bolus injections of 5-FU 400 mg/m2/day and LV 20 mg/m2/day~     for 3 consecutive days every 4 weeks for 2 cycles, and patients in TS-1/irinotecan will be~     treated with irinotecan 40 mg/m2/day on days 1, 8, 15, 22, 29. TS-1 at a dose of 35mg/m2 was~     administered orally twice a day after a meal on the day of irradiation (Monday-Friday)~     concurrent with radiotherapy.~   "
175405|NCT01269203|"~     The goal of this clinical research study is to learn if curcumin can reduce the symptoms~     reported by patients with multiple myeloma (MM) who receive treatment with lenalidomide.~   "
175406|NCT01269190|"~     The goal of this clinical research study is to learn if new imaging devices can help doctors~     decide if a lesion in the mouth is pre-cancerous or cancerous. The new imaging devices use~     different colors of light in mouth imaging.~      This is an investigational study. The HRME, PS2, and MDM devices are not FDA approved or~     commercially available. Their use in this study is investigational. The Identafi 3000 is FDA~     approved and commercially available. Proflavine is not FDA approved or commercially available~     for use as a dye in the mouth. Its use in this study is investigational.~      Up to 275 patients will take part in this study. All will be enrolled at MD Anderson.~   "
175407|NCT01269177|"~     The purpose of this study is to define the current treatment of patients ospitalized with~     acute cardiogenic pulmonary edema. Clinical and laboratory data collected in the Emergency~     Department will used to investigate the primary outcome (mortality) and risk factors related~     to the primary outcome.~   "
175408|NCT01269164|"~     The purpose of this study is to apply human facial allograft transplant to the subjects with~     severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic~     appearance and functional outcome.~   "
175410|NCT01269138|"~     FVII deficiency is a rare coagulation disorder. A limited number of patients are found in~     most treatment centres and countries. Treatment demands vary considerably amongst FVII~     deficient patients. Therefore, regular clinical studies will meet with recruitment problems~     in this particular patient population. The present study intends to elucidate the bleeding~     patterns in a well-defined collective of FVII deficiency patients who are carefully~     characterised, to document the actual use of different treatment modalities in different~     subgroups and to evaluate the efficacy and safety of current available treatment modalities~     in bleedings, surgery and prophylaxis. The purpose is to gain some evidence based knowledge~     of treatment of patients with FVII deficiency - an area where treatment decisions are made~     more on personal clinical experience than on consolidated clinical evidence.~      This study intends to register treatment practices as they are actually performed - in a~     structured and documented way.~   "
175411|NCT01269125|"~     The investigators attempted to establish a rationale for the Gonadotropin Releasing~     Hormone-agonist (GnRH-a) administration, post-laparoscopically, in women with mild~     endometriosis (until stage II, according to AFS) who underwent IVF-ET procedure. Since GnRH-a~     reduces cytokine's concentration in serum (Iwabe et al., 1998; Iwabe et al., 2003) and~     peritoneal fluid of women with endometriosis (Taketani et al., 1992) the investigators~     hypothesized that GnRH-a can reduces also cytokine's concentration in the follicular fluid~     and this action may improve the oocyte quality and the fertility of these women.~   "
175412|NCT01269112|"~     Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on~     account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive~     procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit~     (regional anticoagulation) has been advocated as the method of choice.However, citrate~     anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to~     citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis~     and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with~     frequent monitoring of acid-base and electolytes is also more challenging for the nurses and~     does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis~     in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated~     only for patients at high-risk of bleeding.~      The investigators plan to implement an open-label randomized control trial assessing the~     effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI~     and with a special emphasis on the safety profile of this treatment in patients with severe~     liver failure.~   "
175413|NCT01269099|"~     The increase in stress hormone level and hyperventilation caused by the postoperative pain~     may contribute to the development of hypokalemia during postoperative period. Therefore, if~     the postoperative pain is well controlled by the IV-PCA,the plasma potassium level during the~     postoperative period may be not affected by stress response. The researchers tried to~     investigate the effect of IV-PCA on potassium regulation during the postoperative period.~   "
175414|NCT01269086|"~     The purpose of this study is to determine whether a systematic family assessment in adult~     preventive health visits increases the detection of risk factors in the spouse or adolescent~     child of the screened person.~   "
175415|NCT01269073|"~     This trial is enrolling patients who are already being seen at OHSU sleep disorder center or~     have been referred for clinical reasons by their physician to the OHSU sleep disorder center~     and are going to have a sleep study that would be paid for by their insurance company for~     clinical reasons.~      The purpose of this study is to determine whether the Portland sleep apnea quiz has a higher~     specificity and negative predictive value then the Berlin Sleep Questionnaire in a patient~     population with a high predisposition to sleep apnea presenting to a sleep center.~   "
175416|NCT01269060|"~     Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single~     incision (Embryonic NOTES) colon surgery has been attempted.~      However, there are not sufficient evidences for single incision colon surgery in colon~     cancer.~      The investigators are researching the efficacy and safety of single incision laparoscopic~     sigmoidectomy in sigmoid colon cancer.~   "
175417|NCT01269047|"~     The main purpose of the study is to determine the effects of 16 weeks of adjunctive~     pramlintide or exenatide use on glycemic control in Type 1 Diabetes.~   "
175418|NCT01269034|"~     There are many recent advances in insulin treatment of type 1 diabetes, however after a meal~     sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to~     treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals.~     This study is going to test whether this drug can improve the after meal sugars in people~     with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg)~     and long acting insulin or inulin alone before the boost. There is also a placebo group~     (healthy subjects) who do not get any medication before the boost. Insulin levels and other~     hormones that affect blood glucose as well as your sugar will be measured by a series of~     blood tests. The role exenatide as compared to insulin alone will be examined to prevent low~     blood sugars which might occur because of food staying longer in the stomach than usual or~     due to the suppression of a hormone called glucagon which increases blood sugar. If you~     qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone.~     You and the researchers will not know which dose you are taking at any single visit. A total~     of 20 people in which some will be children aged 12- 18 years will participate, being~     diagnosed within 3 months of having been found to have type 1 diabetes.~   "
175419|NCT01269021|"~     In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open,~     prospective, randomized parallel study to access the efficacy and safety of MMF compared to~     corticosteroid .~      Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the~     MMF group or corticosteroid group.~   "
175435|NCT01268813|"~     The metabolic syndrome is a collection of related risk factors that predispose to the~     development of type 2 diabetes Mellitus and cardiovascular disease. The investigators will~     examine the hypothesis that the metabolic and genomic characteristics of patients with~     metabolic syndrome and/or diabetes that are at risk for developing complications differ from~     each other and can be detected using specific biomarkers in blood or in the exhaled breath.~     Early detection of these individuals will enable personalized treatment to prevent and treat~     diabetes and its complications~   "
175420|NCT01269008|"~     Post-prandial hyperglycemia occurs despite meticulous carbohydrate counting and rapid acting~     insulin therapy. Furthermore, this occurs even in the setting of the closed loop system.~     Currently the algorithm used for calculating the glucose-responsive insulin delivery cannot~     respond in a timely fashion to the glucose absorption resulting from a meal. In diabetes,~     there is paradoxical immediate post-prandial hyperglucagonemia that results in immediate~     post-prandial hyperglycemia. Amylin deficiency and/or dysregulated GLP-1 seems to be the~     etiology. Pharmacologic replacement of these hormones alleviates immediate post-prandial~     hyperglycemia in diabetes. With this protocol, the investigators would like to optimize~     treatment of T1DM by physiologic replacement of hormones in addition to insulin and in the~     process also optimize the insulin algorithm.~      This is a paired, randomized, and controlled comparison of pramlintide and insulin versus~     exenatide and insulin Vs insulin monotherapy using the ePID closed-loop system for insulin~     delivery.~      The investigators will stratify the study subjects into the following sub-groups of 5~     subjects of 22-30 years old, 4 subjects of 18-21 years old, 4 subjects of 16-18 years old.~     The investigators would also begin the study with the 21-25 year patient sub-group and then~     transition to the other sub-groups after evaluating all the safety issues. 22-30 year old~     ones would be considered as an adult subset, 18-21 year olds would be considered pediatric~     subset according to the guidelines of FDA's Center for Devices and Radiological Health (CDRH)~     and 16-18 year olds are considered typical pediatric population. At this time,~     Spanish-speaking subjects will not be recruited because Medtronic Minimed as yet does not~     have any literature in Spanish that may used in explaining the study to this group of~     patients. When in the future Medtronic is able to provide us with the appropriate Spanish~     literature, the investigators will at that time amend the protocol to include this group of~     subjects.~   "
175421|NCT01268995|"~     New onset diabetes after transplantation (NODAT) is a frequent and feared complication after~     kidney transplantation and leads to an increase in cardiovascular complications as well as in~     the rate of graft loss. Very little data exist on how patients in which NODAT has been~     diagnosed should be treated. It is suspected that Cylosporine A (Sandimmun, TM) is less~     diabetogenic than Tacrolimus (Prograf, TM). Furthermore, it has been described that early~     initiation of insulin treatment in Diabetes mellitus type 2 can preserve and improve the~     function of the insulin secreting cells in the pancreas. Therefore, the investigators test~     the effects of conversion from Tacrolimus to Cyclosporine A in patients with newly diagnosed~     NODAT who have just started early treatment with insulin. The hypothesis is that patients who~     are treated with insulin and who are switched to Cyclosporine A have improved glucose~     metabolism compared to patients who are treated with insulin and who remain on Tacrolimus~     therapy.~   "
175422|NCT01268982|"~     In this study, the investigators will evaluate the dimensional changes of alveolar bone in~     the preserved sites in comparison with extraction only conventional healed sockets, as well.~        1. Dimensional changes of the alveolar ridge contour after socket preservation in~          comparison to conventional tooth extraction.~        2. Evaluation the stability of implants placed at the preserved sockets.~        3. Histological evaluation of newly formed bone at the socket preserved sites in comparison~          with extracted only healed sites.~   "
175423|NCT01268969|"~     Comparison between limberg flap and Karydakis flap for treatment of pilonidal disease.~   "
175424|NCT01268956|"~     Correlation of circulating lymphatic endothelial progenitor cells with lymph node metastasis~   "
175425|NCT01268943|"~     The purpose of this study is to seek the proper dose of capecitabine in post-operative~     concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical~     surgery, and evaluate the toleration of this modality in such patients.~   "
175426|NCT01268930|"~     In this study, impacts of hemostatic matrix and bipolar electrocoagulation on ovarian reserve~     in women undergoing ovarian endometrioma excision are compared.~   "
175427|NCT01268917|"~     Antiplatelet therapy is critical in the management of coronary artery disease.For patients~     undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of~     preoperative antiplatelet therapy.And there is little study about the effect of continuing~     aspirin until the surgery day on graft patency.So we would like to perform this study to~     evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump~     coronary bypass.~   "
175428|NCT01268904|"~     To evaluate the safety and efficacy of intravenous valproate in pediatric status epilepticus~     and acute repetitive seizures as part of seizure treatment protocol in pediatric ER~   "
175429|NCT01268891|"~     To evaluate the efficacy of a fixed dose of Azilect® (1 mg/day) vs placebo as assessed by the~     change from baseline in mean total daily OFF time during 18 weeks of treatment in~     levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations in Korea.~   "
175430|NCT01268878|"~     The ending of this study is to describe the effect of febrile neutropenia on patients who~     receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).~   "
175431|NCT01268865|"~     Background: In patients with chronic liver diseases, liver fibrosis staging is crucial for~     hazard evaluation of future disease complication development and thus for the optimal~     decision making on treatment selections.In the era of antiviral and antifibrotic treatments,~     clinical and research demands are also increasing for non-invasive surveillance of liver~     fibrosis to evaluate the progression or regression. However, local baseline data on liver~     stiffness measurement (LSM) using ARFI technique is still lacking in Taiwan, where viral~     hepatitides are highly endemic. Aim: Using the ARFI elastosonography, we are dedicated to the~     aims to recruit patients based on strict but appropriate criteria, to complete the~     correlation and validity studies between ARFI quantification and the referenced METAVIR~     fibrosis scoring and to conduct subsequent innovative studies on liver diseases. Materials~     and Methods: We plan to perform the ARFI quantification for each HBV or HCV-infected patient~     immediately followed by priorly scheduled conventional liver biopsy for METAVIR scoring~     during the same session of examination. Statistics: The first year's study using ARFI will~     focus on the correlation testings and validity studies using receiver operating~     characteristics.~   "
175432|NCT01268852|"~     The hypotheses tested in this study are: There is a statistical significant difference, in~     treatment duration and result of treatment in cases treated using traditional Damon Q~     brackets or using Insignia.~   "
175433|NCT01268839|"~     The purpose of this study is to investigate the pharmacokinetics of TMC278 (rilpivirine) 25~     mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily~     in healthy volunteers~   "
175434|NCT01268826|"~     The aim of the study is to determinate the prevalence of moderate dehydration among children~     aged 9 to 11 who are going to school.~   "
175447|NCT01268657|"~     The purpose of this study is to determine whether a brief intervention for disabling anxiety~     is practical to conduct and beneficial for older adults injured by falls.~   "
175448|NCT01268644|"~     This study will add leptin therapy to the current insulin therapy of Type 1 Diabetics with~     the aim of lowering the total insulin requirements and suppressing the steep fluctuations~     typically associated with Type 1 Diabetes.~   "
175436|NCT01268800|"~     Personalization of AML therapy, require a reliable mechanism for accurate characterization of~     patient specific leukemia phenotype and genotype. Patient's specific leukemic phenotype or in~     practical clinical term, patient's leukemia sensitivity to induction therapy, should best~     investigated in-vivo during induction. Elimination of circulating leukemic blasts from~     peripheral blood by day 5 was shown to discriminate between good responders with superior~     long term survival and poor responders with poor outcome. However, many AML patients have no~     circulating blasts at diagnosis and even in those who have, elimination rate of it from~     peripheral blood was never correlated with actual response in bone marrow.~      Currently, the only available source for patient's specific leukemia profile, is the bone~     marrow sample at diagnosis. Since leukemic blasts are heterogeneous and come from multiple~     different clones, on diagnosis marrow consist a spectrum of chemotherapy sensitive and~     resistance clones. Clones may vary by their molecular abnormalities and results from on~     diagnosis marrow may overlook minor resistant but existing clones. Long term prognosis is~     determined by those resistant clones and though our interests should be focused into the~     abnormalities of these clones. Residual blasts on day 5 marrow may better represent the~     profile of patient's leukemic resistant clones.~   "
175437|NCT01268787|"~     This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine~     at a 0.25ml or 0.5ml dose in health volunteers~   "
175438|NCT01268774|"~     Patients with multiple myeloma have seen their survival rate strongly improved with the use~     of new anti angiogenic agents. Among them, the new chemotherapy with thalidomide or~     lenalinomide are frequently successfully suggested in therapeutic protocol such as MPT~     however they can strongly increase the risk of venous thrombo embolic disease (DVT and PTE)~     up to 20%. In these conditions, a prevention of this risk can be proposed by physician with~     either low molecular weight heparin (LMWH) anticoagulants or antiplatelets agents. Pending~     the new recommendations on the management of VTED, the purpose of this study is to describe~     in real life conditions the management by oncologists of the thrombo embolic risk for such~     patients~   "
175439|NCT01268761|"~     The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of~     early ovarian hyperstimulation syndrome.~   "
175440|NCT01268748|"~     This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than~     conventional laparoscopic cholecystectomy.~   "
175441|NCT01268735|"~     Purpose To try to establish whether lid-parallel conjunctival folds (LIPCOF) can be~     influenced by increased lubrication with rewetting and lubricating eyedrops containing~     hydroxypropyl-guar, which has proven lubricating effect.~      Methods During summer and fall of 2009, 16 ophthalmologists from various regions of Croatia~     investigated the effect of topical therapy with lubricating eyedrops on the signs and~     symptoms of dry eye, with the special emphasis on lid-parallel conjunctival folds (LIPCOF).~     229 patients were enrolled in the study.~      Results After 14 days of therapy with lubricating eyedrops containing hydroxypropyl-guar,~     statistically significant reduction of LIPCOF grade was observed, as well as the reduction of~     symptoms and other signs of dysfunctional tear syndrome (TBUT, Schirmer test, conjunctival~     hyperemia).~      Conclusion Results of this study have shown positive influence of lubricating eyedrops~     containing hydroxypropyl-guar on signs and symptoms of dysfunctional tear syndrome even after~     only 14 days of treatment. It is of particular interest that LIPCOF grade was statistically~     significantly decreased, pointing at increased friction and decreased ocular surface~     lubrication as possible causes of its appearance.~      Having this in mind, every clinician involved in dysfunctional tear syndrome treatment must~     also think about lubrication as integral part of treating this condition.~   "
175442|NCT01268722|"~     This is a multicenter double-arm randomized trial investigating plain balloon angioplasty~     versus primary placement of self-expanding nitinol stents after endovascular recanalization~     of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for detection~     of a significant difference in vessel patency after 1 year.~   "
175443|NCT01268709|"~     The objective of this randomized triple blind controlled trial is to compare the effects of~     Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75~     patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a~     tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete~     evacuation, and bloating are measured and compared between groups at the baseline and one and~     two month after the intervention.~   "
175444|NCT01268696|"~     Metabolic syndrome is a combination of medical disorders that increase the risk of developing~     cardiovascular disease and diabetes. The exact mechanisms of the complex pathways of~     metabolic syndrome are not yet completely known. The pathophysiology is extremely complex and~     has been only partially elucidated. Most patients are older, obese, sedentary, and have a~     degree of insulin resistance. Stress can also be a contributing factor. The most important~     factors are:~      weight, genetics, aging, sedentary lifestyle,excess caloric intake. In our study we will~     assess the role of some polymorphisms in the pathology of metabolic syndrome.~   "
175445|NCT01268683|"~     The study objective is to assess the feasibility of enrolling, evaluating, and treating with~     RP-1127 (Glyburide for Injection) severe anterior circulation ischemic stroke patients,~     whether or not treated with standard of care IV rtPA. Patients must be between 18-80 years of~     age, must have a baseline diffusion weighted image (DWI) lesion volume 82 - 210 cm3, and time~     from symptom onset to start of study infusion must be ≤10 hr.~   "
175446|NCT01268670|"~     Background Approximately 30 million children are treated in emergency departments each year~     in the United States, of which two to three million are children presenting with lacerations.~     Topical numbing medication is the standard of care in children with regard to pain control~     during laceration repair. While topical numbing medications are effective, children often~     require further pain control during laceration repair in the form of an injected numbing~     medication, which in itself is painful. No evidence currently exists regarding the concurrent~     use of oral pain medications to combat laceration procedural pain.~      Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and~     tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during~     laceration repair?~      Design This is a double-blinded, randomized-controlled study.~      Methods Subjects in all three groups will receive topical anesthetic. In addition to topical~     anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or~     oxycodone, while the third group will receive a placebo.~   "
175450|NCT01268618|"~     Primary Objective:~      • To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio~     (professional label) in the improvement of symptoms in adult patients with~     diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia~      Secondary Objective:~      • To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio~     (professional label) in adult patients with IBS-D and functional dyspepsia~   "
175451|NCT01268605|"~     Postoperative hypersensitivity (POH) is a problem for many patients as determined by the~     recent Practitioners Engaged in Applied Research and Learning (PEARL) study of POH following~     occlusal caries restoration. The objectives of this two-armed randomized comparative~     effectiveness research trial (RCERT) are to determine whether adding a resin modified glass~     ionomer liner (RMGI) reduces POH in dentin bonded Class I resin based composite (RBC)~     restorations, and to identify other factors (putative risk factors) that are associated with~     increased POH.~      The primary outcome of this study is the reduction/elimination of restoration POH as measured~     by clinical assessment (air stream) and patient-reports.~      Outcomes will be ascertained via the following specific aims:~      Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by clinical~     measurement (air drying) and by patient-reported outcomes among the two treatment groups at~     three points in time: prior to restoration and at one and four weeks postrestoration.~      Specific Aim 2: To identify putative risk factors for POH (or factors associated with~     differences in POH) including: preoperative caries stage measured by the proposed American~     Dental Association (ADA) Caries Classification System (CCS), lesion depth as measured on the~     preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation~     depth, and patient sleep bruxism status.~   "
175452|NCT01268592|"~     The purpose of this study is to preserve the fertility potential in females diagnosed with~     cancer by vitrifying (rapidly freezing) their oocytes (eggs) before undergoing treatment for~     their cancer.~   "
175453|NCT01268579|"~     Human papillomavirus (HPV-16) is an important factor in the development of many tonsil and/or~     base of tongue squamous cell cancers. Although HPV-16 is not thought to cause cancer by~     itself, it appears to contribute to the development of tonsil and/or base of tongue cancer in~     many patients. It is likely that treatment for many patients with tonsil and/or base of~     tongue cancer could be improved if effective therapy to control HPV-16 is developed. The~     investigators in this study want to learn if ribavirin shows evidence of activity against~     HPV-16.~      Ribavirin is a pill therapy that is approved by the Food and Drug Administration (FDA) as~     part of the standard treatment for Hepatitis C. Laboratory experiments suggest that ribavirin~     might also be useful in the treatment of head and neck cancers. However, ribavirin has not~     yet been tested against head and neck cancer in patients. The purpose of this study is to~     find out the effects of ribavirin on tonsil and base tongue squamous cell cancer in patients.~      The main purpose of this study is to see if ribavirin changes the expression of certain~     proteins related to HPV infection in the tumor. The study will also find out if ribavirin~     changes how the tumor appears in a PET/CT scan (positron emission tomography/computed~     tomography scan).~   "
175454|NCT01268566|"~     The primary objective of this Phase II study is to evaluate the progression-free survival at~     6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who are treated~     with MEDI-575.~   "
175455|NCT01268553|"~     The purpose of this study is to assess tolerability and clinical effects of transition from~     intravenous (IV, needle in the vein) or subcutaneous (SQ, needle in the skin) to the~     recently-approved inhaled treprostinil (Tyvaso) for the treatment of pulmonary arterial~     hypertension (PAH).~      Our hypothesis is that the transition to inhaled treprostinil will be tolerated by patients.~      The intravenous and subcutaneous drugs epoprostenol and treprostinil received approval for~     treatment of PAH many years ago. While these medications improve exercise capacity and the~     symptoms of PAH, they are given by injection and thus have several side effects, such as pain~     and catheter infection. This has resulted in many patients either refusing to take the~     medication or quitting these medications because of not tolerating them.~      The only other form of prostacyclin treatment available for PAH patients is inhaled. There~     are 2 inhaled prostacyclins approved for PAH, however one of these requires at least 6~     inhalations per day, every day, and takes about 30 minutes to inhale each time. Thus, it has~     not been a regularly-used medication and issues surrounding compliance make it a riskier drug~     to use if patients do not get their full doses every day. The other inhaled medication,~     treprostinil, was approved a few months ago, only needs to be given 4 times a day, and takes~     about 2-3 minutes to inhale.~      Since inhaled treprostinil can be administered easily, it is anticipated that many patients~     will transition from epoprostenol or treprostinil to the recently approved inhaled~     treprostinil, however we do not know if this is a safe or effective way to manage patients.~     Thus, the goal of this prospective study is to gather observational data regarding how that~     switch is made, tolerability of the switch, and, to the extent possible with this~     methodology, assess clinical effects of the switch.~      This is a prospective study. Twenty patients > 18 years old with PAH will be enrolled.~     Patients enrolled will be those in whom a clinical decision to convert from either IV~     epoprostenol, IV treprostinil, or SQ treprostinil to inhaled treprostinil therapy has been~     made. This is usually the result of patients asking to switch to inhaled therapy, but only~     allowed by physicians if they feel the switch would be safe.~      If eligible, and after informed consent, patients will have a history and physical~     examination, a 6 min walk test, a cardiopulmonary exercise test (CPET), blood tests, and a~     symptom questionnaire will be filled out. Patients will then be admitted to the hospital~     where a monitoring catheter will be placed inside the patient's heart and inhaled~     treprostinil will be initiated, while the dose of IV/SQ medication is reduced over about~     24-26 hours.~      Clinical follow-up will be at weeks 1, 4, and 12.~      The procedures above are all part of the routine clinical care that patients would receive if~     they were to be transitioned to inhaled therapy, including the hospitalization and~     catheterization. The criteria for them to be able to be switched are conservative. Pressure~     in their heart and lungs must be low (mPAP < 40 mmHg and RAP <12 mmHg on catheterization),~     and their dose of IV or SQ medication must be low (< 20 ng/kg/min). Regarding the patient~     subset enrolled in this study in whom a clinical decision to convert transition therapy has~     been made, we will try to ensure that our clinical decision-making will not be influenced by~     the need to enroll subjects in the study by explicitly noting the potential for conflict of~     interest with each patient (addressed in the ICF). We will not make a clinical decision for~     our patients based on the desire to fill the study numbers, and every will be made to avoid~     the potential for a perceived conflict of interest.~   "
175456|NCT01268540|"~     The purpose of this multi-center clinical trial is to determine the safety and efficacy of~     the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive~     astigmatism.~   "
175457|NCT01268527|"~     The purpose of this study is to investigate the efficacy, safety, tolerability and the~     concentration/response relationship of E6201 in subjects with psoriasis vulgaris.~   "
175458|NCT01268514|"~     The objective of this prospective study is to evaluate short-term, mid-term, and long-term~     clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of~     complex abdominal wall defects~   "
175459|NCT01268501|"~     The purpose of this trial is to evaluate the use of multifocal contact lenses in people who~     use reading glasses only.~   "
175460|NCT01268488|"~     The purpose of this study is to evaluate the performance of an investigational blood glucose~     meter with the Contour sensor strip. It was decided that this investigational monitoring~     system would not be part of a regulatory submission and it will not proceed to marketed~     product.~   "
175461|NCT01268475|"~     Bronchiectasis can be defined as an abnormal and irreversible dilatation of the bronchial~     tree due to repeated cycles of inflammation and infection, resulting in progressive loss of~     lung function. The surgical treatment by pulmonary resection or even lung transplantation is~     indicated in cases of bronchiectasis primary nonresponsive to appropriate medical treatment,~     or when associated with serious complications. There are few literature data on the influence~     of bronchiectasis in exercise capacity, quality of life and functional capacity, and the~     impact of lung resection in patients with this diagnosis. The primary objective of this study~     is to evaluate prospectively the impact of lung resection on exercise capacity in patients~     with clinical and radiological diagnosis of bronchiectasis. The secondary objective of this~     study is to evaluate the impact of lung resection on quality of life and lung function and to~     analyze the the presence of predictors of postoperative functional deterioration and the~     occurrence of complications.~   "
175484|NCT01268176|"~     This study seeks to determine if vitamin D3 absorption in healthy adults will be enhanced in~     the presence of a meal and if the enhancement will be greater when the meal is low as opposed~     to high in fat content. The enhancement will result from increased vitamin D absorption. The~     investigators will test this hypothesis by pursuing the following aims in a 3-mo trial in~     which up to 70 healthy men and women will be randomized to one of the following meal~     conditions under which they will take a monthly oral dose of 50,000 IU of vitamin D3: no meal~     (fasting), a low fat meal, or a high fat meal. The Primary Aim is to identify the meal~     condition (fasting, low-fat, or high-fat meal) under which the 25OHD3 response to~     supplemental vitamin D3 is greatest and most consistent. The Secondary Aim is to determine~     whether vitamin D3 absorption is affected by the meal condition and to determine whether the~     absorption of vitamin D3 predicts the longer-term 25OHD3 response to supplementation.~   "
175485|NCT01268163|"~     The purpose of this study is to compare the pharmacokinetic and safety characteristics of~     European Taxotere® and American Taxotere® with Hospira Docetaxel injection in patients with~     cancer.~   "
175462|NCT01268462|"~     In patients with obstructive lung disease like asthma aerosol therapy is the most used for~     drug administration. A order to make better use of aerosolized drugs in asthmatic patients,~     studies focus on ways to optimize this administration. Objective: To evaluate the efficacy of~     nebulized bronchodilators carried by heliox associated with positive expiratory pressure~     (PEP) in lung deposition of radiation activity in adult asthmatic patients between episodes~     and its impact on lung function. Methods: A randomized controlled trial involving 32 with a~     mean age of 47.28 ± 9.67 of which 25% of the sample are male, these patients were divided~     into four groups: heliox + PEP, + PEP oxygen, heliox and oxygen in Regarding the~     anthropometric characteristics, parameters and cardiopulmonary baseline spirometry data were~     similar for all groups. For inhalation lung scintigraphy was used a noninvasive delivery~     system - orofacial mask with two unidirectional valves nontoxic - inspiratory and expiratory~     branch - connected to the nebulizer for radioisotopes associated with PEP of 10 cm H2O. At~     the end of inhalation, the images were acquired in a scintillation camera at 0, 15, 30, 45~     and 60 min. In order to analyze the aerosol deposition in different lung areas were~     delineated regions of interest (ROIs) in the vertical - the upper, middle and bottom - and~     horizontal central, intermediate and peripheral. Results: The spirometric data showed an~     increase in the values of forced expiratory volume in one second (FEV1) predicted when~     compared with the heliox group + PEP (80%, p = 0.030) with PEP + O2 (65%, p = 0.030). As for~     CI, there was also an increase in PEP + heliox group (0.05 L, p = 0.012) compared to groups~     without oxygen and heliox PEP (0.03 L, 0.03 L, p = 0.012 respectively) for the total number~     of counts, no differences were seen between groups with heliox and oxygen with PEP PEP~     (482510, 577598, p = 0.262 respectively) for the total number of counts by comparing the~     oxygen group + PEP (577,598) with the heliox group (332,951, p = 0.004) and oxygen without~     PEP (409,526, p = 0.045), there was a greater number of counts in the O2 + PEP group. By~     analyzing the rate of pulmonary deposition (IDP) in the vertical gradient, higher deposition~     in the middle third (p = 0.001) when compared to upper and lower in both groups. With regard~     to IDPs in the horizontal gradient, there was greater deposition in the intermediate region~     when compared to central and peripheral (p = 0.003, 0.001 respectively) in all groups. As the~     penetration rate, no significant differences between groups (p = 0.726). When considering the~     pulmonary clearance, decreased with the number of counts over time within groups (p <0.05)~     but no differences between them: heliox + PEP (20.67%), PEP + oxygen (13.50%), heliox~     (16.27%) and oxygen (16%) - (p> 0.05). Conclusion: Although no differences in the rate of~     penetration and clearance of pulmonary radiation activity between groups, we noted a higher~     number of counts in patients who underwent nebulization with oxygen associated with PEP and a~     functional improvement in patients who underwent nebulization with PEP as spirometric values~     and CI.~   "
175463|NCT01268449|"~     The purpose of this study is to determine wether low dose laser is effective on idiopathic~     subjective tinnitus.~   "
175464|NCT01268436|"~     Toothache is a common source of pain for Emergency Department patients. There are several~     common ways to control the pain of toothache. But we do not know if any one of them is more~     effective than another. It is also possible that how we take care of your pain in the~     Emergency Department will influence the level of pain you experience one or two days from~     now. This study seeks to answer these questions.~   "
175465|NCT01268423|"~     The aim of the study is to determine if performing an early tracheostomy (within the first 4~     days of endotracheal intubation) in critically ill patients on mechanical ventilation,~     reduces the incidence of swallowing dysfunction.~   "
175466|NCT01268410|"~     Acute respiratory failure is a common entity in intensive care units nowadays and is~     associated with significant morbidity and mortality, thus representing a major health~     problem. Most of the published epidemiological studies on this condition were performed when~     modern ventilatory strategies and non-invasive ventilation were not available. Therefore, an~     actual evaluation on the incidence and outcomes of this syndrome is mandatory. We will~     perform an observational prospective study of patients admitted with acute respiratory~     insufficiency in several ICUs in Brazil.~   "
175467|NCT01268397|"~     The purpose of this study is to examine whether operation and fixation with a metal plate~     gives better result from the patient's perspective than plaster treatment in elderly patients~     with a displaced wrist fracture.~   "
175468|NCT01268384|"~     The rationale for phase II trial of neoadjuvant fixed dose rate gemcitabine plus capecitabine~     for patients with LAPC includes the following: First, obtaining a sufficient tumor~     down-staging to procure R0/R1 resection, reported to be one of the most significant~     prognostic factors for survival; second, providing an observation period to exclude from~     surgery those patients with rapidly progressive disease there by to help select patients for~     surgery who have the greatest likelihood of a favorable postoperative outcome; third,~     eliminating micrometastatic disease, that is likely present in most patients, earlier than~     adjuvant setting and preventing post-surgical growth spurts; fourth, adjuvant therapy given~     in the neoadjuvant setting is better tolerated, as the patient has not recently undergone a~     major operation; and the last, the lack of widely accepted optimal preoperative or palliative~     approach in patients with LAPC, the majority of whom may not be operated on.~      The primary goal is to determine the R0 resection rate of the neoadjuvant fixed dose rate~     (FDR) gemcitabine-capecitabine combination chemotherapy in patients with borderline~     resectable or unresectable locally advanced pancreatic adenocarcinoma.~      The secondary goals are to assess progression-free survival (PFS) and OS (overall survival)~     in these patients and to assess adverse events of these neoadjuvant treatments.~   "
175469|NCT01268371|"~     To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus~     Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)~   "
175470|NCT01268358|"~     This is a single-center, open-label, dose escalation study of patients with~     alpha-mannosidosis. 10 patients will be enrolled in this study receiving intravenous~     infusions of Lamazym. In order to avoid development of delayed hypersensitivity all patients~     will continue weekly treatment at the designated dose until the Safety Committee approves~     transfer to the rhLAMAN-03 protocol.~      It is the hypothesis that Lamazym is safe to use.~   "
175471|NCT01268345|"~     Blood glucose monitoring system are tested in the alternative site to validate the accuracy~     of the blood glucose.~   "
175472|NCT01268332|"~     The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR~     in HIV uninfected women over 12 weeks of use.~   "
175473|NCT01268319|"~     The CANARY (Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow)~     Study is a pivotal trial to evaluate criteria for defining a Lipid Core Plaque (LCP) that is~     at high risk of rupturing during standard of care therapy and causing intra-procedural~     complications. If plaques that require treatment are at higher than normal risk of causing~     intra-procedural complications, some life threatening, the treating physician is better~     informed and may opt to take precautionary measures to mitigate the risk or result of a~     complication. The CANARY Study is also designed to evaluate the feasibility of using a distal~     embolization protection device (EPD) as a means to prevent heart attacks triggered by the~     embolization of plaque during standard care therapy. It is thought that the EPD will prevent~     plaque from going downstream during treatment and obstructing other heart vessels. These~     obstructions could cause heart attacks by preventing blood from reaching heart muscle tissue.~   "
175486|NCT01268150|"~     The purpose of this study is to assess the efficacy and safety of single-agent eribulin~     mesylate for first-line treatment of subjects with locally recurrent or metastatic breast~     cancer.~   "
175474|NCT01268306|"~     Corneal epithelial disruption, commonly termed corneal staining has been frequently~     associated with contact lens wear. Previous research has demonstrated higher levels of~     observed corneal staining when certain combinations of contact lenses and lens care products~     are used, particularly under daily wear regimens. B+L lenses made from Balafilcon~     (PureVision) have been associated with the highest rates of observed staining. Additionally,~     polyhexamethylene biguanide (PHMB) based lens care products, specifically B+L ReNu MultiPlus~     have been implicated in higher rates of staining. In general, many lenses constructed from~     newer, silicone hydrogel (SiHy) materials appear more susceptible to increased rates and~     amounts of corneal staining.~      Although the clinical significance of staining is debated, most clinicians agree that less~     staining is preferable to greater amounts of staining. Advances in understanding as well as~     the specifics of lens care product formulation ideally will have resulted in design of newer~     products that minimize corneal staining and maximize product performance. This study will~     examine rates of corneal staining using B+L's recently introduced lens care product: BioTrue~     with the B+L PureVision lens which has previously been associated with the highest levels of~     staining.~   "
175475|NCT01268293|"~     The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg~     when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1~     cycle) in subjects with solid tumors~   "
175476|NCT01268280|"~     The primary objective of this early-stage clinical study is to demonstrate an effect of~     single doses of CK-2017357 on measures of skeletal muscle function and fatigability in~     patients with generalized myasthenia gravis (MG).~   "
175477|NCT01268267|"~     The purpose of this study is to evaluate the performance and acceptability of an~     investigational blood glucose monitoring system, which includes meter and sensor strip.~   "
175478|NCT01268254|"~     The investigators will evaluate 100 regular red wine consumer men and 100 abstainers men from~     50 years-old to 70 years-old by coronary risk prevalence, mood status, anthropometric~     measures, daily caloric ingest, lipid profile, carotid intimal media thickness, brachial flow~     mediate dilatation, coronary tomographic angiography and leucocyte telomere length.~      The sample size has been calculated expecting that regular red wine ingestion would lead to a~     five year old younger vascular ageing indexes measured by carotid intimal media thickness,~     coronary artery calcium scores and leucocyte telomere length longer than those abstainers~     subjects at same age.~      The investigators hypothesized that regular wine consumers present less coronary lesion and~     coronary calcium score on coronary tomographic angiography, lower carotid intimal media~     thickness and higher mean telomere length due the benefice of wine.~   "
175479|NCT01268241|"~     The current approved treatment for Fabry disease is enzyme replacement therapy (ERT). There~     are actually 2 products in this therapeutic class available: Replagal® (agalsidase alfa) and~     Fabrazyme® (agalsidase beta). Both are indicated for long-term treatment in patients with a~     confirmed diagnosis of Fabry disease (alfa-galactosidase A deficiency). Both have been~     commercially available in Europe for almost 10 years, yet little information is available~     about the clinical and safety profile of patients who switch from one therapy to the other.~     An extended shortage of Fabrazyme® that began in June 2009 has necessitated that a large~     number of patients switch from Fabrazyme® to Replagal®. This offers the possibility to study~     the clinical status and adverse events in patients who switch from Fabrazyme® to Replagal® on~     a large-scale basis. In addition, as a result of the increasing Fabrazyme® shortage, many of~     these patients received a reduced dosage of Fabrazyme® for an extended period before~     transitioning to treatment with Replagal®.~   "
175480|NCT01268228|"~     The coronary bifurcation lesions pose a therapeutic problem with high rates of periprocedural~     complications, higher rates of in-stent restenosis and stent thrombosis. These are lesions~     where stenting is not superior in comparison to balloon angioplasty in regard to side branch.~     It was demonstrated many times, in literature and in daily practice, that angiographically~     high grade ostial side branch stenosis is not flow limiting and do not cause ischemia,~     therefore do not require treatment. From the other side, our own data with MRI before and~     after bifurcation PCI demonstrated that occurrence of angiographic stenosis more than 70% in~     diameter is associated with periprocedural myonecrosis in the region of side branch. This~     fact puts a very important question about the mechanisms of this myonecrosis. If the jailed~     side branch has no significant flow limiting stenosis, but there is some degree of residual~     ischemia, which after some period of persistence could lead to myonecrosis, will mean that~     more aggressive treatment of ostial stenosis is needed. It is interesting that the strategy~     of treatment is very important, because techniques with second stent implantation (with~     primary purpose to limit SB ischemia) are associated with higher grade of troponin increase.~     Of course this is association and not causality, despite that in randomized study (NORDIC I)~     it was confirmed also.~      It is without explanation the fact of rare occurrence of significant (flow limiting, FFR~     <.75) stenosis appearance (less than 40% in side branches with ostial stenosis more than 75%)~     and almost 50% periprocedural myonecrosis detected in the side branch areas. One working~     hypothesis is that stent implantation and related episode of ischemia induces prolonged~     vasospasm, resulting in prolonged ischemia. Thus, the ostial stenosis could be~     non-significant as estimated and registered by FFR, but on microcirculatory lever ischemia~     could persist is small areas for which available flow is not sufficient despite that global~     regional flow is deemed sufficient. It is also possible that those patients have not enough~     recruitable collaterals. It is also possible that both factors act together.~      Although FFR is useful for assessing the degree of ischemia caused by a coronary lesion, it~     cannot give information as to whether this ischemia may be clinically significant or not,~     i.e. whether the ischemia affects a large territory. Therefore, it can be implicated that FFR~     may not be useful in predicting clinically meaningful ischemia in a specific side branch~     vessel.~      The intracoronary electrocardiography (i.c. ECG) is a very sensitive method for ischemia~     detection. The i.c. ECG reacts earlier on ischemia; the changes are much more prominent and~     easy to register. The wire tip could be positioned directly in different regions and thus to~     map regional ischemia. In most of the studies and from our own observations became evident~     that when surface ECG do not react the i.c. ECG demonstrates significant changes in~     ST-segment and QRS complex. Moreover, the registration of i.c. ECG is very cheap and needs~     only an adapter connecting coronary wire end and ECG. An i.c. ECG also can differentiate~     residual ischemic changes in distal main vessel and side branch as sources of prolonged~     ischemia, respectively - source of periprocedural myonecrosis.~      The objective of this study is to evaluate the clinical significance of side branch vessel by~     occluding the blood flow with a 1-minute balloon occlusion. We will also assess whether there~     is any change in ECG (i.c. and 12-lead surface records) on balloon occlusion and relation~     with periprocedural myonecrosis.~   "
175481|NCT01268215|"~     A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of~     pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic~     treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low~     birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the~     tracheal aspirate before and after instillation of the study drugs.~   "
175482|NCT01268202|"~     Molecular mechanisms involved in radio-induced fibrosis are assessed in UPRES EA 27-10 since~     10 years. Besides the canonical TGFbeta/ Smad pathway involved in radio-induced fibrosis~     (RIF), the Rho/ROCK/CTGF cascade has been shown to be also implicated in molecular mechanisms~     of RIF. Curative administration of Pravastatin or ROCK specific inhibitors inhibits the~     chronically activated Rho/ROCK/CTGF pathway in vitro in human cells lines and ex vivo in~     human samples. In addition, the curative administration of Pravastatin improves established~     RIF in vivo. The investigators data suggest that the pravastatin-based strategy is an~     efficient and safe antifibrotic therapy, easily transferable into the clinic to improve the~     quality of life of long-term cancer survivors without interfering with prior anticancer~     treatment.~      This clinical trial evaluates the curative efficacy of Pravastatine in patients who presented~     a cutaneous and/ or subcutaneous fibrosis (grade >= 2 according to NCI-CTCAE v4 toxicities~     scale) and who were treated by radiotherapy for a head and neck cancer. Patients will be~     treated by Pravastatin during 12 months. An intermediate evaluation of efficacy by ultrasound~     will be assessed at 6 months and at last, at the end of the treatment. Patients assessment~     will be performed at 6 and 12 months after the end of the treatment to look at a potential~     rebound effect.~      Objective(s) of the clinical study~      Main objective: To assess Pravastatin efficacy in established cutaneous and subcutaneous~     radio-induced fibrosis revealed from 6 to 24 months after head and neck radiotherapy.~      Second objective: To evaluate radio-induced fibrosis regression during the year following~     treatment stop.~   "
175483|NCT01268189|"~     This is a single-center, prospective, randomized, and controlled study to evaluate the~     effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites~     compared to our current standard donor site dressing (Xeroform). Hypothesis is that the mean~     healing time for wounds treated with the OxyBand dressing will be less than the mean healing~     time for wounds treated with the Xeroform dressing.~   "
175487|NCT01268137|"~     This study aims at assessing efficacy and safety of DBS for treatment of patients suffering~     from resistant major depression, by means of a random, controlled and crossed study.~   "
175488|NCT01268124|"~     This is a phase 1, randomized (a process that is used to decide whether you will take study~     drug or a placebo during the study), inpatient study which will assess the safety and~     tolerability of HTC-867 in healthy male Japanese subjects.~   "
175489|NCT01268111|"~     Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D~     replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before~     and after the intervention, and the changes will be compared between the two groups. This~     will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol~     Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are~     mediated by RBP4.~   "
175490|NCT01268098|"~     Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults~     with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and~     vitamin D supplements.~   "
175491|NCT01268085|"~     In recent years, multiple articles have highlighted the increased risk of developing cancer~     from ionizing radiation. The risk increases with higher radiation doses, and accumulates with~     repeated scans.~      Hospitals with computerized physician order entry systems (CPOE) have the unique opportunity~     to use decision support on radiation safety to influence a physician's ordering practice in~     real-time. An ideal decision support tool for radiation safety will educate the physician~     about the dangers of cumulative ionizing radiation, present the patient's image history, and~     guide the provider to the best modality that meets the patient's diagnostic needs with as~     little radiation exposure as possible. The design challenge is to create a decision support~     tool that appropriately protects the investigators patients from overutilization of CAT~     scans, without inadvertently leading to underutilization of CAT scans or inappropriate~     utilization of alternative tests.~      This research protocol proposes to study one such design at a large, academic medical center.~   "
175492|NCT01268072|"~     The primary objective of this study is to identify biomarkers that can be used for evaluation~     of efficacy in subjects presenting with AECOPD~   "
175493|NCT01268059|"~     The purpose of this study is to evaluate the dose, antitumor activity, safety and~     pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with~     previously untreated, advanced non-small cell lung cancer (NSCLC).~   "
175494|NCT01268046|"~     This study will focus on how aging affects changes in the way the brain works when affected~     by estrogen in areas of the brain associated with memory.~   "
175495|NCT01268033|"~     Background~      Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with~     immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).~      Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with~     failure or toxic side effects of other immunosuppressant treatments is a major matter of~     concern.~      Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this~     treatment for years. At the same time, low doses of cyclosporine allow proteinuria to~     reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis.~     Some recent data lead to the conclusion that Rituximab may be effective in such a disease,~     with a cyclosporin sparing effect.~      Purpose~      The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment~     of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome.~      Abstract Patients will be included in the study in a period of remission of proteinuria. Two~     infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one~     week of interval. Other immunosuppressant treatments will be gradually tapered off with the~     same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding~     code will be broken. Rituximab will then be infused to patients having received placebo.~   "
175496|NCT01268020|"~     The underlying goal of this study is to assess [18F]-FMH3 PET imaging as a tool to evaluate~     the activity of the H3 receptor in the brain of Alzheimer Disease (AD) research participants~   "
175497|NCT01268007|"~     This is an observational, un-blinded, non-significant risk, non-interventional study designed~     to collect ECG data on at least one subject out of a pool of up to three (3) healthy male~     subjects at one clinical site (Clinical Trials of Texas). Cyberonics will be collecting ECG~     recordings collected by an investigational device for comparison with conventional ECG~     recordings. This data will be used to validate a new device under development.~   "
175498|NCT01267994|"~     The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist)~     can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED)~     that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to~     be enrolled will have recently completed a course of oral steroids and demonstrated no change~     in their audiometric thresholds following corticosteroid therapy.~   "
175499|NCT01267981|"~     The best preparation of small bowel is still unknown. The primary aim of this study is to~     evaluate the polyethylene glycol (PEG) impact of small bowel preparation for unexplained~     gastrointestinal bleeding exploration. Three different preparations are evaluated in this~     study.~   "
175500|NCT01267968|"~     GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that~     inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with~     tRNA and is currently in development for the treatment of hospital acquired Gram-negative~     infections (including E. coli, K. pneumoniae, and Enterobacter spp.).~      This is an open-label, randomized, single period, parallel-cohort pharmacokinetic study to~     evaluate serum and pulmonary pharmacokinetics following single dose and multiple dose~     administration of intravenous GSK2251052. In Cohort 1, approximately 15 healthy adult~     subjects will be randomized to receive a single IV dose of GSK2251052 1500 mg in the fasted~     state. Following the dose, bronchoalveolar lavage (BAL) fluid and serial plasma samples will~     be collected for determination of GSK2251052 parent and metabolite concentrations. In Cohort~     2, approximately 15 healthy adult subjects will receive GSK2251052 1500 mg IV BID x 5 doses~     (Cohort 2). Following the last dose in the fasted state, bronchoalveolar lavage (BAL) fluid~     and serial plasma samples will be collected for determination of GSK2251052 parent and~     metabolite concentrations. Vital signs, ECGs, and adverse events will be monitored throughout~     the study. A follow up visit will occur 10 to 14 days after the last dose of study drug.~   "
175501|NCT01267955|"~     This phase II trial studies how well vismodegib works in treating patients with~     chondrosarcomas that have spread to other places in the body and usually cannot be cured or~     controlled with treatment. Drugs used in chemotherapy, such as vismodegib, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading.~   "
175503|NCT01267929|"~     This study aimed to develop Video Compact Disc (VCD) program that applying the concept of~     imitative learning with mirror neurons stimulation on standard rehabilitation technique in~     children with cerebral palsy. The author will also examine effectiveness of the program by~     compare the motor function measured by the gross motor function measure (GMFM-66) between~     conventional physical therapy and the mirror neurons stimulation based VCD program for six~     months.~   "
175504|NCT01267916|"~     It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive~     end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine~     position. The investigators tried to investigate the effect of low respiratory rate and high~     tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general~     anesthesia.~   "
175505|NCT01267903|"~     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused~     by viruses that belong to the enterovirus genus of the picornavirus family. Although most~     HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71~     (EV71) can present with a high rate of neurological complications, including~     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by~     EV71 has become a major emerging infectious disease in Asia and the highly pathogenic~     potential of EV71 clearly requires the attention of world medical community.~      The development of vaccine against EV71 is active and ongoing in Asian countries now. Several~     studies have examined the effectiveness of inactivated viral vaccines against EV71 in animal~     model. A wide range of experimental EV71 vaccine approaches have been studied including~     heat-inactivated or formaldehyde-inactivated virion, EV71 virus-like particles (VLP) , VP1~     recombinant protein ,VP1 DNA vaccine , VP1 peptide-based vaccine targeting the neutralizing~     domain, bacterial or viral vector expressing VP1, and a Vero cell-adapted live attenuated~     virus. Furthermore, neutralizing antibodies against EV71 have been suggested as one of the~     most important factors in prevention of the severe EV71 infection. Recently, an inactivated~     vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase~     Ia is armed to evaluate safety and tolerance in Chinese healthy adults and children.~   "
175506|NCT01267890|"~     This study is a prospective cross-sectional survey study. The investigators developed~     self-administrated questionnaire and recruit 120 physicians in two hospitals and 60 lawyers~     from some law firms to this study.~      To realize and compare the opinions of physicians and lawyers about controversial~     decision-making of surrogate.~   "
175507|NCT01267877|"~     The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines for~     breast cancer screening for women in their 40's and assess the effect of one of two newspaper~     articles on their attitudes. The population studied was women seeing their private~     gynecologist for annual exams in the 39-49 year old age group.~   "
175508|NCT01267864|"~     This randomized study is testing 3 different intravenous medications to see which one is best~     for acute migraine. The three medications are metoclopramide, valproate, and ketorolac.~   "
175509|NCT01267851|"~     The database and biobank establishment started in 1997 in our institute. However, the sample~     size was too small with respect to our clinical and fundamental scientific research's~     requirement. Thus the Chinese gynecological oncology study (GOS) group was established to~     create a large multicentre database and biobank of patients with gynecologic diseases.~   "
175510|NCT01267838|"~     BBK- 2 - study:~      STUDY-SUMMARY~      Background:~      The need for stenting of the main and side branch (double stenting) in the treatment of~     coronary bifurcation lesion primarily depends on the complexity of the bifurcation lesion. If~     the bifurcation lesion is very complex (Medina classification 111, severe stenosis of both~     branches, severe calcified lesion, long lesions etc.) double stenting may be the treatment of~     choice. When double stenting is required, the most frequently used stenting techniques are~     T-stenting and Culotte-stenting. It is still unclear, however, which double stent technique~     yields the best long-term outcome.~      Aim:~      This randomized study will compare the long-term safety and efficacy of T-stenting versus~     Culotte-stenting in the treatment of de-novo coronary bifurcation lesions with drug-eluting~     stents.~      Methods:~      Three-hundred patients in whom a double-stenting technique is intended for the treatment of a~     de-novo coronary bifurcation lesion will be randomly assigned to T-stenting or~     Culotte-stenting with an approved drug-eluting stent. Patients will undergo 9-month~     angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planed~     at 30 days, 6 months, 1 year, 2 years, 3 years and 5 years. The primary study endpoint is the~     maximal percent diameter stenosis in the bifurcation lesion at 9 months. Secondary endpoints~     include binary restenosis (estimated by Quantitative Coronary Angiography (QCA) analysis),~     Target Lesion Revascularisation (TLR), Freedom from Major Adverse Cardiac Events (MACE) and~     the rate of stent thrombosis according to the definition of the Academic Research Consortium~     (ARC definition). The study will have 90% power to detect a 25% reduction in the primary~     endpoint at p < 0.05.~   "
175511|NCT01267825|"~     Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe~     that it is functionally disabling. The purpose of this randomized clinical trial is to~     determine if corticosteroid medication, delivered directly to the area near the herniated~     disc, can improve the pain and functional disability associated with a herniated disc.~   "
175512|NCT01267812|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Giving bortezomib~     together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib and rituximab together~     works in treating patients with mantle cell lymphoma who have previously undergone stem cell~     transplantation~   "
175513|NCT01267799|"~     Photocopiers are indispensable in today's working environment. However, photocopiers emit a~     number of harmful chemicals during their operation. Photocopier toners also contain a number~     of potentially toxic substances. Chronic exposure to these substances may compromise the~     health of photocopier operators. This study is aimed to understand if chronic exposure to~     photocopier emissions is harmful to human health.~   "
175514|NCT01267786|"~     The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic~     function after ischemic/reperfusion injury and the sequence influence on renal and~     cardiovascular systems.~   "
175515|NCT01267773|"~     Having both depression and conduct problems at the same time has been found to be associated~     with increased risk for the other and increased risk of negative outcomes. This study will~     develop an family based cognitive behavioral treatment protocol for youths with both conduct~     problems and depression, that will take be administered over the course of six months. Youth~     with comorbid conduct problems and depression will be assigned to the experimental condition~     or treatment as usual in a community care setting. The treatment manual will be revised as~     needed. Youth will be assessed before and after treatment to examine program potential. The~     goal of this research is to develop a more comprehensive outpatient treatment for youth with~     both conduct problems and depression.~   "
175516|NCT01267760|"~     The purpose of this study is to investigate whether recycled dialysis fluid can supply enough~     clearance for hemodiaysis patients.~   "
175517|NCT01267747|"~     Primary objective of the PAPPHY Study is to establish the prevalence of primary aldosteronism~     (PA) in consecutive hypertensive patients hospitalized for lone (non valvular), paroxysmal,~     persistent or permanent atrial flutter or fibrillation (AFF).~      Secondary objectives are to identify:~        1. the clinical, echocardiographic and biochemical predictors of AFF in the hypertensive~          patients with/without PA;~        2. if AFF, by increasing ANP and/o BNP thereby conceivably blunting aldosterone secretion,~          can lower the ARR and impede PA detection.~        3. the usefulness of the aldosterone-to-renin ratio (ARR) based on plasma renin activity~          (PRA) and the direct measurement of renin (DRA) for diagnosing PA in patients with AFF.~        4. the rate of recurrence or new onset AFF during follow-up in a cohort of hypertensive~          patients with/without PA as a function of specific treatment for the latter.~      Design: cohort multicenter prospective study. Sample size: 1000 consecutive patients.~      Procedure At baseline cardiac function, arterial stiffness, and plasma renin activity (PRA),~     direct renin assay (DRA), plasma aldosterone (PAC) will be measured. Pharmacologic or direct~     current cardioversion (DCC) will be performed if indicated according to 2010 ESC guidelines.~      PRA and PAC will be measured again 2 weeks after cardioversion to answer secondary aim b.~      If ARR is > 26 and PAC > 15 ng/dL, adrenal vein sampling (AVS) will be performed in patients~     willing to undergo adrenalectomy to identify a lateralized PAC excess.~      Follow-up will be aimed at assessing damage organ, occurrence of cardiovascular events and~     recurrence of AFF in patients with or without PA.~      Demonstration of a higher prevalence of PA in the patients with AFF as compared to the~     general population of the hypertensive subjects will provide evidence for 1) a role of~     aldosterone excess in causing AFF and cardiac electric remodeling; 2) the usefulness of case~     detection of PA in hypertensive patients with AFF; 3) the predictors of AFF; 4) the outcome~     of specific treatment for PA on risk of incident and recurrent AFF.~   "
175518|NCT01267734|"~     Objectives~        1. To compare the safety and long-term effectiveness of coronary stenting with the new~          platform Everolimus-Eluting coronary stenting system (EECSS, Promus Element) compared~          with the Zotarolimus-Eluting coronary stenting system (ZECSS, Endeavor Resolute) in~          patients with coronary heart disease (CHD)~        2. To determine the short-term efficacy and safety of triple anti-platelet therapy (TAT,~          Aspirin 100mg qd, Clopidogrel 75mg qd and Cilostazol 100mg bid) compared with~          double-dose clopidogrel dual anti-platelet therapy (DDAT, Aspirin 100mg qd and~          Clopidogrel 150mg qd) in patients undergoing percutaneous coronary intervention (PCI)~          with drug-eluting stents (DES)~      Study design Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to~     test the following in CHD patients~        1. Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in~          reducing target lesion failure (TLF)~        2. Non-inferiority of TAT compared with DDAT in reducing net clinical outcome Patients will~          be randomized in a 2-by-2 factorial manner according to the type of drug eluting stent~          (EECSS vs. ZECSS) and the type anti-platelet regimen (TAT vs. DDAT). Randomization will~          also be stratified per presence of DM.~      Patient enrollment 3750 patients enrolled at 50 centers in Republic of Korea~      Patient follow-up Clinical follow-up will occur at 1, 3, 12, 24, 36 months after the~     procedure. Angiographical follow-up will be recommended to all participants at 13 months~     after the procedure. Investigator or designee may conduct follow-up as telephone contacts or~     office visits.~      Primary endpoint~        1. Target lesion failure (TLF), defined as a composite of cardiac death, target~          vessel-related myocardial infarction (MI) and ischemia-driven target lesion~          revascularization (TLR) up to 12 months for the stent arm~        2. Net clinical outcome, defined as a composite of cardiac death, nonfatal MI, CVA and~          major bleeding by PLATO criteria at 1 month for the anti-platelet arm~   "
175519|NCT01267721|"~     It has been repeatedly demonstrated that cardiac surgery with the use of extracorporeal~     circulation elicits a systemic inflammatory response and provokes ischemia-reperfusion~     related oxidative stress which could further lead to the development of organ failure in~     critically ill patients. Perioperative levels of macrophage migration inhibitory factor (MIF)~     and other inflammatory mediators could be involved in adverse outcomes in cardiac surgery.~   "
175520|NCT01267708|"~     The purpose of this study is to examine PLT function in PCI patients.~   "
175521|NCT01267695|"~     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the~     chance of relapse after surgery. This phase II trial is studying the effectiveness of~     perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal~     stromal tumor.~   "
175522|NCT01267682|"~     The purpose of this study is to test the effectiveness of cognitively stimulating activities~     for resolving delirium in people with dementia.~   "
175523|NCT01267669|"~     Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of~     acute variceal bleeding and five-day haemostasis has been shown to significantly improve when~     vasoactive drug is added. However, there is limited data whether addition of somatostatin, to~     endoscopic variceal ligation (EVL) improves the efficacy of EVL.~      Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal~     bleeding.~      Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from~     esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized~     to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was~     treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour~     after start of therapy or death.~   "
175524|NCT01267643|"~     Aplastic Anemia (AA) is an autoimmune hematologic stem cell disease mediated by activated~     T-lymphocytes that leads to pancytopenia. The disease related morbidity and mortality if left~     untreated can approach 90%. For over 30 years, anti-thymocyte globulin (ATG) in combination~     with cyclosporine (CsA) remains the standard therapy. However, the treatment response with~     ATG is at best between 50-60% with a sizeable number of partial responses. Treatment with ATG~     is also associated with significant toxicity and high relapse rate that can be as high as~     45%. Since the prognosis in refractory and relapsed AA remains poor, there is a need for less~     toxic novel immunosuppressive agents that can improve response rates and remission duration~     in refractory and relapsed AA.~      Alefacept is a human recombinant dimeric fusion protein composed of the terminal portion of~     leukocyte functioning antigen-3 (LFA3/CD58) and the Fc portion of human IgG1. It prevents~     co-stimulatory signals between antigen presenting cells and memory T cells by competitive~     inhibition of CD2 in T cells, induces selective apoptosis of CD4+ and CD8+ memory effector T~     cells by interaction between the Fc portion of IgG1 and the FcyIII in NK cells, and possibly~     direct ligation of CD2 molecules on T cells that subsequently result in the alteration in T~     cell agonist signaling. It has been used successfully in the treatment of other T cell~     mediated disorders particularly psoriasis and steroid refractory graft versus host disease~     (GVHD) with minimal side effects. In a case of liver transplant associated AA (similar to~     transfusion associated AA) which is fatal in most patients, Alefacept induced remission after~     patient did not respond to ATG and other immunosuppressants. The investigators hypothesize~     that the LFA3-CD2 co-stimulatory pathway play an important role in the immune pathogenesis of~     AA and treatment with Alefacept can help treat refractory/relapsed cases of AA.~   "
175525|NCT01267630|"~     The purpose of this study is to determine the validity and reliability of the Thai version of~     the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the~     prevalence of delirium in elderly.~   "
175526|NCT01267617|"~     To determine if proprietary software that uses pulse-wave analysis to interpret the output of~     a conventional pulse-oximeter, can predict the onset of circulatory stress, before changes in~     blood pressure and pulse occur, in patients undergoing outpatient hemodialysis.~   "
175527|NCT01267604|"~     An efficient protocol of ovarian stimulation is a key part of assisted reproductive~     technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous~     studies have evaluated the efficiency of the clinical approaches currently available.~      Recent studies have shown that two natural compounds, such as inositol and melatonin, play an~     important role in oocyte maturation and quality. Therefore, the present study aims at~     investigating whether inositol and melatonin are able to improve the number of oocytes~     obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).~      To this purpose, a randomized double-blind trial will be established where 150 healthy women~     in reproductive age undergoing to assistant reproductive technology (ART) because of male~     infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone,~     group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.~      As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical~     pregnancy rate and live birth rate will be evaluated in group A vs. group B.~   "
175528|NCT01267591|"~     Background: The reactive hyperemia-peripheral artery tonometry (RH-PAT) is a newly developed~     method for noninvasive endothelial function assessment.~      Objective: The goal of this study is to determine whether a significant difference in RH-PAT~     score is present between adolescents with type 1 diabetes (T1D) in comparison with controls.~     We will also compare RH-PAT scores in obese adolescents versus controls.~   "
175529|NCT01267578|"~     The purpose of this study is to evaluate overall survival and immunological monitoring for~     peptide vaccination therapy using novel cancer testis antigens (STF-II) for locally advanced,~     recurrent, or metastatic esophageal squamous cell carcinoma~   "
175530|NCT01267565|"~     Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff~     contribute to the constitution of VAP. The pepsin has been recently proved effective as a~     surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin~     dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The~     aim of our study is to asses whether the value of amylase, which is mostly secreted by~     salivary glands, may turn out to be a new and simpler surrogate for microaspirations in~     ventilated ICU patients. Thirty patients ventilated for an anticipated length > 48h whose~     endotracheal tube includes a subglottic secretion device and producing sufficient~     endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral,~     subglottic, tracheal) will be performed during one ventilation day for amylase dosage~     purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed.~     In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a~     tracheal aspiration during the procedure will be included as a control group. The primary~     assessment criteria will be the oral/tracheal amylase ratio.~   "
175531|NCT01267552|"~     To study the safety of not draining the axilla, after breast conserving surgery and full~     axillary lymphadenectomy.~   "
175532|NCT01267539|"~     A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City~     Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice~     daily for four weeks.~   "
175533|NCT01267526|"~     This is a Canadian, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth~     hormone treatment from hospital and to assess the level of adherence of subject receiving~     SAIZEN® via Easypod™ .~   "
175534|NCT01267513|"~     Ambulatory monitoring of physiological variables is important in following the health status~     of individuals in non-hospital controlled situations. The investigators are developing a~     non-invasive sensor based on dynamic light scattering that is able to measure pulse, blood~     flow and coagulability. Oxygen saturation can also be detected with minor modification of the~     apparatus. The investigators plan to validate the investigators sensor by applying it to~     patients in the intensive care unit, or to patients undergoing cardiac stress tests. The~     results of the investigators sensor will not be utilized for any therapeutic decisions, but~     will be collected for later comparison with conventional monitoring of pulse and oxygenation~     with standard monitors. The monitor is worn like a wrist watch, and will collect data into a~     small data storage disc for later analysis.~   "
175535|NCT01267500|"~     Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help~     in increasing control of strabismus~   "
175536|NCT01267487|"~     There are currently several schemes described for anticoagulation with heparin and its~     reversal with protamine during cardiac surgery with CPB. The oldest, and most used in our~     routine environment, is the scheme of fixed doses, in which a bolus dose of heparin at the~     start of CPB is established in IU/kg of body weight and the dose of protamine at the end of~     CPB is calculated based on the initial dose of heparin administered.~      These schemes do not take into account the variability inter-patients and can result in~     overdose or sub-doses of one or both drugs.~      The titration schedule of doses of heparin and protamine through the principle of~     dose-response curve of Bull promotes individualization of dosage according to the response of~     each patient. This scheme has been associated with an effective reversal of the effect of~     heparin after CPB and with reduction of post-operatory bleeding and transfusion.~      The restoration of a state of anticoagulation by heparin after its reversal by protamine is~     called rebound effect. It is a phenomenon explained by the recirculation of heparin stored~     in the reticulum-endothelial system and connective tissue, or by free residual concentration~     of heparin after clearance of protamine. This effect may be present for more than 6 hours of~     post-operatory and may contribute to increase post-operatory bleeding.~   "
175537|NCT01267474|"~     The main objective was to evaluate the effect of a nutritional education program for school~     lunch cooks, aiming to reduce added sugar in schools meals and in their sugar intake.~   "
175552|NCT01267279|"~     In a randomized, double-blind trial, BMD of the operated proximal femur after total hip~     replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two~     years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n =~     24) at two weeks and one year after surgery.~   "
175538|NCT01267461|"~     Recently the general medical literature has become aware that the use of certain long-acting~     insulin analogues could potentially increase cancer risk.During the last few years the~     investigators group generated information of both scientific and clinical relevance on the~     proliferative and anti-apoptotic actions of insulin analogues. The goal of this project is to~     evaluate the hypothesis that the proliferative and signalling activities elicited by insulin~     analogues may have a impact on tumor behavior. In this study the investigators will asses the~     biological actions of insulin analogs in primary tumor cells of endometrial and colon cancer.~   "
175539|NCT01267448|"~     Saxagliptin + Metformin XR (S+M) will be effective in stabilizing blood glucose (BG) levels~     in patients with newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia (BG levels~     300 to 450 mg/dl) and glucose toxicity and with no criteria for inpatient admission or~     occurrence of severe hypoglycemia compared to glipizide XL.~      The study may provide preliminary evidence to support the role of S+M as a bridging,~     stabilizing and safe therapy in patients with severe hyperglycemia~   "
175540|NCT01267435|"~     The purpose of this study is to evaluate the accuracy of tunnel positions in anterior~     cruciate ligament reconstruction~   "
175541|NCT01267422|"~     This study is meant to assess the safety and efficacy of rAAV2-ND4 treatment of Leber~     hereditary optic neuropathy with 11778 LHON mutation.~   "
175542|NCT01267409|"~     Depressive symptoms of Parkinson's disease (PD) patients are major predictors of their~     prognosis and quality of life. Using subthalamic nucleus (STN) deep brain stimulation (DBS)~     as an antidepressant could be a promising new direction. Existing methods of adjustment of~     DBS parameters aim at amelioration of the motor signs and therefore with inactivation of the~     STN motor territory only. Although the DBS parameter setting is believed to influence the~     mental state, there is no data that correlates stimulation parameters with mental state. The~     investigators hypothesize that the emotional territories of the STN have distinct~     electrophysiological properties and that specific stimulation of these emotional territories~     can influence the mental state and thus treatment with emotionally-adjusted DBS can improve~     the psychiatric symptoms of PD. In this project, the investigators intend to map the~     emotional territories of the STN using neuronal (single units) responses to emotional voices~     and to identify the emotional spectral signature of the STN single unit activity using~     spectral analysis and neuronal responses to emotional voices. The investigators also intend~     to investigate the emotional processing of PD patients by manipulating the stimulation of the~     subthalamic area. The proposed study will combine neural recording, stimulation and~     psychological tests to shed new light on emotional processing in the basal ganglia, as well~     as to provide better treatment for PD emotional disorders,~   "
175543|NCT01267396|"~     The objective of this study was to compare and evaluate the single-dose oral bioavailability~     of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr. Reddy's Laboratories~     Limited) with the reference formulation ZOLOFT® 100 mg Tablet (Pfizer)under fasting~     conditions in healthy adult human subjects.~   "
175544|NCT01267383|"~     The objective of this study was to compare and evaluate the single-dose oral bioavailability~     of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr. Reddy's Laboratories~     Limited) with the reference formulation ZOLOFT® 100 mg Tablet (Pfizer)under fed conditions in~     healthy adult human subjects.~   "
175545|NCT01267370|"~     The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of~     chronic constipation.~   "
175546|NCT01267357|"~     P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma.~     Evidence from previous trials indicates that it may be used as a diagnostic biomarker~     distinguishing this disease from endometrioid endometrial cancer. Additional evidence points~     to its prognostic value.~      The current study will evaluate p16 both as a diagnostic tool for serous papillary~     endometrial cancer and as a prognostic biomarker.~      following anonymization, histology blocks will be microtomed and stained for P16 and P53~     proteins.~      Blocks from endometrioid endometrial cancer will be used as a control group.~   "
175547|NCT01267344|"~     The primary objective is to investigate the objective response rate in patients receiving~     GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or~     metastatic unresectable BTC biliary tract cancer compared to patients receiving the same~     chemotherapy without cetuximab. The secondary objectives include the exploration of the~     effect of the multimodality strategy on progression-free and overall survival, biomarker~     prediction, and toxicity.~   "
175548|NCT01267331|"~     This prospective, randomized, placebo-controlled study was designed to assess the safety,~     feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear~     cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass~     surgery.~   "
175549|NCT01267318|"~     Development of a new diagnostic detection tool for gastrointestinal bleeding.~   "
175550|NCT01267305|"~     The purpose of this study is to determine whether the use of different dose of LMWH compared~     with fondaparinux for thromboprophylaxis is efficacious and safety after thoracic surgery.~   "
175551|NCT01267292|"~     Chronic cocaine use may produce disruption of neurotransmitter functions (including~     dopamine). This may in turn contribute to measurable dysfunction in important cognitive and~     behavioral processes. Stimulants that enhance dopamine (DA) function may help in treating~     cocaine dependence and improving behavioral function -- supporting the notion that these~     processes are related. An important step is to understand the subjective, physiological, and~     behavioral effects of potential medications for cocaine dependence.~      DA-modulating drugs may be targets for pharmacotherapy for substance dependence, and~     particularly for stimulant drugs like cocaine, which disrupt normal DA function. Buspirone is~     currently the only available dopamine subtype 3 (DA3) approved for human administration, and~     is thus a viable investigational compound.~      This project proposes to evaluate the DA-modulating effects of buspirone on behavioral~     deficiencies related to DA depletion. Accordingly, the project aims to characterize the~     effects of buspirone in individuals with cocaine dependence. Employing a daily dosing designs~     within an acute stimulant challenge (methylphenidate), the experiment will characterize the~     subjective effects, cardiovascular effects, and behavioral effects (attentional bias to drug~     cues and risky decision making). The primary hypotheses are that buspirone will attenuate the~     increases in subjective drug effects (stimulated, like drug) and behavioral effects~     (increases in attentional bias and risky decision making) that are produced by acute~     methylphenidate administration.~   "
175554|NCT01267253|"~     This phase II trial studies how well brivanib alaninate works in treating patients with~     cervical cancer that has come back. Brivanib alaninate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.~   "
175555|NCT01267240|"~     This partially randomized phase II trial studies giving capecitabine and vorinostat in~     treating patients with head and neck cancer that has come back after previous treatment or~     that has spread to other areas in the body. Drugs used in chemotherapy, such as capecitabine,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. It is not yet known whether giving capecitabine~     together with vorinostat is more effective than capecitabine alone in treating patients with~     cancer of the head and neck cancer.~   "
175556|NCT01267227|"~     Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries,~     that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative~     stress. The purpose of this study is to evaluate whether pterostilbene will help control~     cholesterol and blood pressure, as well as improve markers for oxidative stress in patients~     with dyslipidemia meeting inclusion criteria. The investigators also want to look at the~     safety of pterostilbene in these patients.~   "
175557|NCT01267214|"~     The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal~     tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were~     treated with osteotomy will not be treated with any SYSADOA after operation, even though~     their cartilage's not completely loss, so osteotomy plus HA injection should provide more~     benefit to patients than osteotomy alone.~   "
175558|NCT01267201|"~     A new formulation of methylprednisolone is being developed. A study is needed to determine~     the drug availability using the new formulation, a powder for reconstitution into a~     suspension, versus the current commercially available tablet formulation in healthy~     volunteers.~   "
175559|NCT01267188|"~     The purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and~     50 mg) of NBI-98854 for the treatment of the symptoms of tardive dyskinesia (TD) in subjects~     with schizophrenia or schizoaffective disorder.~   "
175560|NCT01267175|"~     The user evaluation is to assess user acceptance and the quality of training materials for~     the MiniMed Paradigm® X54 System (X54 System) in preparation for commercial distribution of~     the new system.~   "
175561|NCT01267162|"~     This is a Phase IV, open-label, single-arm, 96 week community-based observational study~     evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected~     Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123~     study. The primary objective of this study is to evaluate the long-term antiviral efficacy of~     tenofovir DF 300 mg once daily in these patients. The secondary objectives are to evaluate~     the safety and tolerability of TDF including the biochemical and virological responses to~     TDF, the incidence of drug resistance mutations in these patients The duration of treatment~     in this study is total of three Years (144 weeks) on TDF.~   "
175562|NCT01267149|"~     Statistical Hypotheses The Null Hypothesis: There is no difference in the reduction of lines~     in the treated areas as compared to baseline.~      Alternative Hypothesis: There is a difference in the reduction of lines in the treated areas~     as compared to baseline.~   "
175563|NCT01267136|"~     Tonsillectomy is the most common pediatric surgical procedure performed in the US. The~     postoperative period can be particularly painful. Codeine (usually in mixed formulation with~     acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data~     questions its ability to provide optimal pain relief, while avoiding side effects, especially~     in the postoperative setting. Tramadol may be a better option for children in the~     postoperative setting due to its well-documented analgesic properties, low potential for side~     effects, and excellent safety profile. Seventy-two children scheduled to undergo~     tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate in~     a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of~     codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers will~     be asked to record daily information about their child's postoperative pain and other core~     outcomes and domains as recommended in the recent consensus statement put forth by the~     Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials~     (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the~     efficacy and side effects associated with tramadol as compared with codeine/acetaminophen~     (the current practice standard) in a pediatric population.~      Hypotheses~      H1: Children who receive scheduled tramadol following tonsillectomy will report better pain~     control than children who receive scheduled codeine/acetaminophen.~      H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side~     effects than children who receive scheduled codeine/acetaminophen.~   "
175564|NCT01267123|"~     Colonoscopy is a procedure commonly performed to screen for colon cancer and to look for and~     remove colon polyps. It involves inserting a flexible tube, equipped with a video-camera at~     the tip, through the colon. The insertion process can be difficult in some patients,~     resulting in an uncomfortable and lengthy procedure.We postulate that raising the foot of the~     bed so that the stretcher forms a 15 degrees angle with the floor (Trendelenburg position)~     may make the colonoscopy easier and more comfortable to the patient.~   "
175565|NCT01267110|"~     Breast cancer is the second most common cause of cancer death in the U.S.1 in spite of being~     preventable, easily detectable, and curable.2-11 Breast screening continues to be~     underutilized by the general population and especially by traditionally underserved minority~     populations. Two of the least screened minority groups are American Indians/Alaska Natives~     (AI/AN) and Latinas. American Indian/Alaska Native women have the poorest recorded 5-year~     cancer survival rates of any ethnic group and the lowest (or near-lowest) screening rates for~     major cancers.12 Furthermore, breast cancer is the number one cause of cancer mortality among~     Latina women.13 While breast cancer screening rates have increased nationally, there has been~     an increase in the gap in breast cancer screening utilization between individuals from~     minority versus majority racial/ethnic groups.~   "
176224|NCT01258517|"~     The purpose of this study is to assess changes in cerebral oxygenation during two different~     types (beractant and poractant) and two different routes (double lumen or single lumen~     endotracheal tube) of surfactant administration using near infrared spectroscopy (NIRS).~   "
175566|NCT01267097|"~     The Canadian pediatric obesity epidemic has led to great interest in evaluating weight~     management care for obese children and families. Investigation is warranted since obesity is~     linked to risk factors for chronic diseases including type 2 diabetes mellitus (T2DM) and~     cardiovascular disease (CVD). Over the past 25 years, many interventions have studied the~     role of healthy lifestyle behaviours to help obese children achieve and maintain a healthy~     weight. A contemporary view of pediatric weight management interventions includes parents as~     a fundamental recipient of treatment. These interventions recognize the influence parents~     have on the lifestyle behaviours of their children. While such parent-based interventions~     have helped establish the role of education and behavioural theory in facilitating lifestyle~     changes, we believe an equally important intervention element is a focus on the role of~     cognitions in helping to interpret behaviour change and change maintenance. Our study~     incorporates cognitive behaviour theory (CBT) into an intervention for parents of obese~     children and compares it to a more traditional modality based on psycho-education (PEP).~      Hypothesis: Obese 8 - 12 year old children (n=45) whose parents complete a 16-session,~     group-based, CBT intervention will achieve greater reductions in adiposity as well as~     improvements in physiological risk factors for T2D, lifestyle behaviours, and psychosocial~     outcomes at post-intervention as well as 6- and 12-months follow-up versus children (n=45)~     whose parents complete a 16-session, group-based, psycho-education intervention .~      Primary Objective: To compare the impact of two weight management interventions (CBT versus~     PEP) for parents of obese children on child BMI z-score.~      Secondary Objective: To measure a comprehensive set of physiological, behavioural and~     psychosocial outcomes in obese children and parents pre- and post-intervention.~      We expect obese children whose parents complete the CBT intervention will experience greater~     reductions in BMI z-score vs. children whose parents complete the PEP intervention. We~     anticipate that improvements in parenting style, family stress, and lifestyle behaviours will~     be important to improve adiposity, lifestyle behaviours, and risk factors for T2DM and CVD in~     obese children.~   "
175567|NCT01267084|"~     The purpose of this study is to evaluate the potential effects of ketoconazole on blood~     levels of trabectedin after administration to patients with advanced malignancies.~   "
175568|NCT01267071|"~     The purpose of this study is to determine the absolute oral bioavailability and intravenous~     pharmacokinetics of GSK962040. The oral dose of 50 mg has been selected because it was well~     tolerated following single oral administration and it is considered to be within therapeutic~     dose range. The need to characterize the intravenous disposition of GSK962040 is in~     anticipation of drug use in special populations such as critically.~   "
175569|NCT01267058|"~     The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline~     Biologicals' (formerly known as SmithKline Beecham Biologicals) combined~     diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards,~     in Australia.~   "
175570|NCT01267045|"~     This pilot study is a two arm randomized, controlled clinical trial that evaluated whether a~     standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms~     associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Fifty-five~     veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to treatment as~     usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures were collected at~     baseline, immediate post-MBSR, and 6 months post intervention. Measures were obtained at~     equivalent time points for veterans randomized to TAU only. Following completion of all study~     activities, veterans randomized to TAU only had the opportunity to enroll in MBSR.~   "
175571|NCT01267032|"~     This project is designed to determine whether an efficacious behavioral intervention for~     insomnia can improve the quit rates achieved by an efficacious smoking cessation program~     aimed at PTSD patients (Integrated Care). A second aim is to deepen our understanding of~     the mechanisms relating sleep and smoking in PTSD.~   "
175572|NCT01267019|"~     Veterans with schizophrenia and schizoaffective disorder experience high levels of disability~     and poor community outcome, and these poor functional outcomes constitute a major public~     health concern. The treatment of schizophrenia spectrum disorders has shifted fundamentally~     from a focus on symptom reduction to a focus on recovery and improving aspects of~     functioning. Needed improvements in community outcome for patients with these disorders will~     not occur simply through better control of clinical symptoms. Instead, it is necessary to~     find new treatments that address the key determinants of poor functional outcome, including~     social cognition. Both basic (non-social) cognition and social cognition are considered key~     determinants of functional outcome for schizophrenia and schizoaffective disorder. Basic~     cognition includes the domains of: learning and memory, vigilance / attention, speed of~     processing, reasoning and problem solving, and working memory. Social cognition generally~     refers to mental operations that underlie social interactions, including perceiving,~     interpreting, managing, and generating responses to socially relevant stimuli, including the~     intentions and behaviors of others. As part of the investigators' previous Merit grant, they~     have developed a training program for social cognition and are in the process of validating~     it. Initial results suggest that the program improves performance on measures of social~     cognition and functional capacity.~      In this study, the investigators will evaluate whether adding an in vivo component (training~     activities that occur in the community) to the current social cognition intervention~     facilitates generalization of training effects to community outcome and subjective~     satisfaction. Outcome measures of social cognition and functional capacity will be examined~     during the 12 week training program, and durability of benefits will be assessed at a 3-month~     follow up. Generalization to community functioning and subjective satisfaction will be~     assessed at the end of training and at the 3-month follow up. The investigators will enroll~     105 patients across the 5 years of the study with random assignment to training group (social~     cognition intervention with in vivo exercises, social cognition intervention without in vivo~     exercises and control). Subjects will receive assessments at baseline, 6 weeks (mid-point),~     completion of training (12 weeks), and the 3-month follow up.~   "
175573|NCT01267006|"~     This study will invite two groups of volunteers to participate.~      The data from one group of volunteers will be used to find out how much study drug, known as~     GSK1325756, is in the blood after taking the drug twice in one day. Data will also collected~     to find out if the level of cetain blood cells, known as neutrophils, change significantly~     after taking the study drug twice in one day. This group of volunteers will be aged 40 to 64~     years of age.~      The data from the other group of volunteers will be used to find out if taking the study~     drug, GSK1325756, twice in one day with or without food, makes a difference to the level of~     study drug in the blood. This group of volunteers will also provide data to find out if any~     study drug metabolites are present in the bile, a fluid secreted by the liver. This group of~     volunteers will be aged 65 to 80 years of age.~   "
175574|NCT01266993|"~     The purpose of the study is to evaluate the persistence of the immune response of GSK134612~     vaccine up to 68 months after vaccination in the primary vaccination study (NCT number =~     NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and~     immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary~     vaccination study with either GSK134612 vaccine or Menjugate®.~      This protocol posting deals with objectives & outcome measures of the persistence and booster~     epochs. The objectives & outcome measures of the primary epoch are presented in a separate~     protocol posting (NCT number = NCT00674583)~   "
175575|NCT01266980|"~     This study will assess the saftey of giving fluticasone furoate 200mcg/GW642444M 25mcg once~     daily for 7 days to patients with severe renal imparement. The results of this study will aid~     in deciding whether a FF/GW642444M doseadjustment is justified in subjects with severe renal~     impairment and in estimating any such adjustments.~   "
175576|NCT01266967|"~     This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of~     an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or~     V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have~     received any local brain therapy, and subjects in Cohort B will have received prior local~     therapy for brain metastases. Subjects will continue on treatment until disease progression,~     death, or unacceptable adverse event.~   "
175577|NCT01266954|"~     The purpose of this study is to explore the potential dose response relationship between the~     pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose~     metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed~     with repeat escalating doses of GSK2141795. [18F] FDG PET imaging and optional tumor biopsies~     will be done prior to initiation of dosing and sequentially at select time points during the~     first five weeks of dosing. The maximal dose of a given schedule evaluated in this study will~     not exceed the maximal tolerated dose established in the first-time-in-human trial PCS112689~     for the same schedule.~   "
175578|NCT01266941|"~     In relation to their severity, hepatic diseases can significantly modify drug absorption and~     disposition and consequently can interfere with drug efficacy and/or produce toxicity. The~     purpose of this study will be to aid in deciding whether a dose adjustment is required in~     subjects with hepatic impairment and in estimating any such adjustments.~   "
175579|NCT01266928|"~     Preterm premature rupture of membranes (PPROM) is a complication affecting 3-4.5% of all~     pregnancies. PPROM is the main known cause of preterm delivery and is associated worldwide~     with increased rates of neonatal and maternal morbidity and mortality. Despite its frequency,~     very little is known about its pathophysiologic mechanisms. Mechanical strength is provided~     to fetal membranes by an extracellular collagen matrix. Types I, II, III and IV are the main~     collagen types in these membranes. Studies have shown that total collagen content is reduced~     in the amnion of women with preterm PROM.~      Vitamin C is involved in the metabolism of collagen and has been proposed to play an~     important role in the maintenance of the integrity of the chorioamniotic membranes. Vitamin E~     may play a synergic role with vitamin C, increasing the antioxidant capacity against reactive~     oxygen. Woods et al hypothesized that an increase in dietary consumption or supplementation~     of vitamin C and E during pregnancy might reduce the risk of that portion of preterm PROM~     that may be mediated by oxidative injury to fetal membranes. Plessinger et al report that~     pretreatment of human amnion-chorion with vitamins C and E prevents hypochlorous acid-induced~     membrane damage.~      Borna et al. reported a randomized, double-blind controlled study of vitamin C and E~     supplementation, in which women with preterm rupture of membranes and singleton gestations at~     26 to 34 weeks were randomized to vitamin C and E supplementation or placebo. Supplementation~     with vitamin C and E were associated with longer latency before delivery. However, the sample~     size in this study was very small.~      The aim of this study was to evaluate the effect of supplementation with vitamins C and E~     after preterm premature rupture of membranes. We hypothesised that supplementation vitamins C~     and E may be effective in decreasing oxidative stress and increasing the latency period.~   "
175580|NCT01266915|"~     Approximately 1.4 million individuals in the United States have systemic lupus erythematosus,~     and about 85% of these individuals develop skin lesions at some point of their disease.~     Cutaneous lupus erythematosus represents the skin manifestations of systemic lupus~     erythematosus, and can appear in people with or without systemic lupus. It is a mentally,~     physically, and emotionally debilitating disease that affects both the quality of life and~     social well-being of those affected.~      The cause of cutaneous lupus is not completely understood, but likely includes multiple~     factors from our genes and the environment. Multiple genetic studies with small numbers of~     cutaneous lupus patients have been performed to determine which genes are associated with~     cutaneous lupus. This study aims to accumulate even larger numbers of patients to confidently~     identify genes and the proteins they encode that could contribute greatly to the formation of~     cutaneous lupus. The discovery of these genes and proteins would help not only uncover how~     cutaneous lupus forms, but also improve our abilities to diagnose this disease and predict~     its course, and stimulate new drug development.~   "
175581|NCT01266902|"~     The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients~     who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.~   "
175582|NCT01266889|"~     The aim of the study was investigated the cerebral tissue oxygenation index (c-TOI) measured~     by near infrared spectroscopy (NIRS)in the preterm infants with intracranial haemorrhagia.~   "
175583|NCT01266876|"~     The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in~     participants diagnosed with heterozygous familial hypercholesterolemia (heFH)~   "
175584|NCT01266863|"~     To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram~     analysis is required. E test strips have successfully provided an antibiogram 24 h after~     having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective~     cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with~     the aim of validating a new method increasing the rapidity of antibiogram analysis compared~     to standard methods of culture. This antibiogram will be provided by E test strips directly~     applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour~     after its completion. The occurrence of major errors (S with E test method, I or R with~     standard method) and minor errors (I or R with E test method and S with standard method)will~     be observed and a comparison of H6, H10 and H24 results performed.~   "
175585|NCT01266850|"~     Rotavirus, sometimes called the stomach flu, is the most common cause of severe diarrhea in~     children. Vaccines can prevent many types of infections and work by causing the body to make~     proteins called antibodies that fight infection. For some vaccines, more than one vaccination~     is needed so that the body will make enough antibodies to fight infection. The vaccines~     (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the~     Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices~     (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants~     between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12~     months. Study procedures include reaction assessment and blood sample.~   "
175586|NCT01266837|"~     A single arm, open-label, multi-center phase IV clinical trial for patients with metastatic~     renal cell carcinoma, who have progressed on or after the first VEGF-targeted therapy.~   "
175587|NCT01266824|"~     In this study, we will be evaluating whether premedication with an anesthetic eye drops leads~     to a decreased sensation of pain when given dilating eye drops prior to eye examinations to~     evaluate for retinopathy of prematurity in neonatal intensive care unit (NICU) infants.~   "
175588|NCT01266811|"~     The purpose of this study is to determine if there is an improvement in progression-free~     survival (length of time during and after treatment in which a patient is living with a~     disease that does not get worse) when siltuximab is added to VELCADE and dexamethasone in~     subjects with relapsed or refractory multiple myeloma.~   "
175601|NCT01266642|"~     The goal of this clinical research study is to compare how 4 weeks of radiation treatment~     affects the breast to how 6 weeks of radiation treatment affects the breast.~      Researchers also want to know about other side effects of radiation.~      This is an investigational study. Both the standard and the shorter radiation courses are~     FDA-approved in patients with breast cancer. The goal of this study is to compare the 2~     treatments.~      Up to 288 participants will be enrolled in this study. All will be enrolled at MD Anderson.~   "
175589|NCT01266798|"~     Access to the best available evidence, and the ability to obtain and understand such~     information is seen as necessary to protect the public's interests and critical to~     empowerment, but is also a precondition for participation in the decision making.~      A web portal serving as a generic (non disease- specific) tailored tool was developed in the~     conceptual framework of shared decision making and evidence based practice to improve the~     lay- public's critical and social literacy skills and activation. A randomized controlled~     parallel trial using a simple randomization procedure will be conducted, including 200~     parents of children <4 with internet access. Parents will be allocated to receive either the~     portal or no intervention. Primary and secondary outcomes include: the ability to find~     research based information, critical appraisal skills, perceived behavioural control,~     attitudes and perceived pressure associated with searching for information, and~     participation.~   "
175590|NCT01266785|"~     Crohn's disease is an inflammatory (swelling and soreness) disorder of the digestive tract.~     Affected patients suffer from abdominal pains, diarrhea (sometimes bloody), weight loss. It~     is a lifelong disease with frequent flares during the course of the disease. Crohn's disease~     is mostly treated with medications, sometimes surgery is needed. Infliximab is a medication~     for treating severe Crohn's disease. This medicine is effective by blocking special substance~     (tumor necrosis factor) released from certain white blood cells in the body. Infliximab is~     given via a vessel at week 0, 2, 6 initially, then every 2 monthly for maintenance. However,~     some of patients with Crohn's disease do not respond infliximab. Currently there is no test~     to reveal which patients will respond to treatment. This study aims to analyze and compare~     particular subgroup of white cells and its products during and after infliximab treatment~     which may determine the responsiveness to infliximab treatment.~   "
175591|NCT01266772|"~     This is 9 month, placebo-controlled, double blind, randomised trial using the oral~     leucotrienes receptor antagonist montelukast (5 mg) in 160 children with mild and moderate~     asthma age 6-14 year old, sensitive to house dust mite. There are two study groups:~     montelukast group 80 patients and placebo group 80 patients. All patients will receive~     budesonide in dose sufficient to control asthma symptoms and short-acting beta agonist as~     needed. Medication used in the study: montelukast 5mg, budesonide. There are 7 doctor's~     visits - one initial visit (June) and 6 follow-up visits. First visit is on the first day of~     asthma symptom and each follow-up visit is every 6 weeks. Children with full asthma control~     (as measured by exhaled NO) had administered 100 mcg lower dose of budesonide and children~     with not fully control asthma had administered 100 mcg higher dose of budesonide.~   "
175592|NCT01266759|"~     To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral~     Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age~   "
175593|NCT01266746|"~     The aim of this study is to determine the condition to detect the status of a macular hole by~     spectral domain optical coherence tomography (SD-OCT) in gas-filled eyes. The macular area is~     scanned by SD-OCT (OCT-4000, Carl Zeiss Meditec) in the patients who underwent vitreous~     surgery for macular hole to detect macular jole closure on postoperative days 1, 3, 7, and~     30.~   "
175594|NCT01266733|"~     The purpose of this study is to assess improvement in health related quality of life of~     fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual~     treatment.~   "
175595|NCT01266720|"~     The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with~     gemcitabine in treating HLA-A*0201 restricted patient with non-resectable pancreatic cancer.~   "
175596|NCT01266707|"~     The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in~     treating HLA-A*2402 restricted patients with advanced hepatocellular carcinoma.~   "
175597|NCT01266694|"~     Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery.~      Objective: To assess whether colchicine is effective in reducing post operative pericardial~     effusion volume.~      Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention :~     colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac~     rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate~     to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by~     echocardiography) more than 7 days after cardiac surgery.~      Measurements: The main end point will be change in effusion grade after 14 days of treatment.~     Secondary endpoints include frequency of late cardiac tamponade.~   "
175598|NCT01266681|"~     Persistent Atrial Fibrillation (AF) is a common and distressing cardiac arrhythmia and~     accounts for 1% of the healthcare budget in the UK and it's prevalence is rising. Symptoms of~     atrial fibrillation include palpitations, chest pain , shortness of breath and fatigue, with~     quality of life measures reduced for patients with persistent AF, increased stroke risk and~     increased all cause mortality rates. DC Cardioversion is used to restore normal sinus rhythm~     in patients with persistent AF. It has a high success rate but reoccurence of AF is common.~     The use of anti arrhythmic drugs (AADs) can augment the number of patients remaining in sinus~     rhythm at one year, with amiodarone currently the most superior. Unfortunately it can have~     serious side affects. Dronedarone is a related drug designed specifically to minimise the~     most serious side affects and is no approved and used prominently in the management of non~     permanent AF. However it has not yet been studied in a post DC Cardioversion population.~      Patients in persistent AF who are referred for elective DC Cardioversionwill be randomised to~     receive either Amiodarone or Dronedarone to compare the ability to help maintain sinu rhythm~     post cardioverion in one NHS hospital. Patients will be followed up for a year post~     cardioversion to see if they stay in sinus rhythm.~      Ho: there will be no difference in maintenance of sinus rhythm with the use of amiodarone or~     dronedarone~   "
175599|NCT01266668|"~     The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL~     using a matched pair analysis following strict matching criteria in patients with primary~     breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin,~     vincristine, and prednisone (R-CHOP) regimen.~   "
175600|NCT01266655|"~     There is first evidence from preclinical and clinical studies for the efficacy of the~     selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of~     this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen~     for relapse prevention in alcohol-dependent patients.~   "
175602|NCT01266629|"~     Capsule endoscopy (CE) is considered as a gold standard examination for small bowel Crohn's~     disease. However, it is time-consuming, expensive and results are largely influenced by the~     operator's skills. We, therefore, want to assess the predictive value of fecal calprotectin~     and lactoferrin in patients undergoing CE.~   "
175603|NCT01266616|"~     Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural~     immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study~     will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is~     safe and effective. This study will also test a new way of giving the vaccine called~     electroporation (EP).~   "
175604|NCT01266603|"~     The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2),~     when given in combination with recMAGE-A3 + AS15 ASCI (Antigen-Specific Cancer~     Immunotherapeutic), can help to control unresectable or metastatic melanoma in patients whose~     tumor tissue has the MAGE-A3 protein. The safety of this drug combination will also be~     studied. Researchers will also use samples of the original tumor or metastatic tissue (for~     example, lymph nodes or liver or lung) that are collected during screening to study if~     response to the study drug is related to the genes in the tissue.~   "
175605|NCT01266590|"~     The purpose of this study is to determine how much digoxin gets into the blood stream and how~     long it takes the body to get rid of it when given with LY2216684. Information about any side~     effects that may occur will also be collected.~   "
175606|NCT01266577|"~     Background:~      - Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of~     the human body and evaluate activity in the brain. A particular MRI method called magnetic~     resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help~     researchers who are studying new treatments for psychiatric illnesses. Researchers are~     interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS~     techniques to view and measure brain chemicals and brain activity.~      Objectives:~      - To implement, develop, and optimize brain chemistry imaging techniques using magnetic~     resonance imaging and magnetic resonance spectroscopy.~      Eligibility:~      - Healthy individuals between 18 and 65 years of age.~      Design:~        -  This study will involve a screening visit and a scanning visit at the National~          Institutes of Health Clinical Center.~        -  Participants will be screened with a full medical and physical examination, blood and~          urine tests, and neurological testing.~        -  During the second visit, participants will have an MRI scan of the brain. (Participants~          who have received an MRI within the past year will not need to have a second one; the~          images of the previous scan will be used for this study.) All participants will then~          have an MRS scan using the same scanning equipment.~   "
175607|NCT01266564|"~     This observational study will assess the progression-free survival, overall response and~     safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in~     patients with metastatic colorectal cancer. Data will be collected from patients for~     approximately 2 years.~   "
175608|NCT01266551|"~     What's known? Prone position is no longer a treatment option for GERD because of the~     association with SIDS. Originally, positioning in an infant seat was recommended for infants~     with GERD. However, Orenstein proved this position has a detrimental effect on GER, compared~     to prone positioning.~      What's new? Positioning in an infant seat caused no increase in GER, compared with the supine~     15 degrees anti-Trendelenburg position. Except for the number of long reflux episodes, which~     was significantly higher in the car safety seat. Larger trials are needed for decisive~     conclusions.~   "
175609|NCT01266538|"~     This will be a comprehensive epidemiological, clinical, endoscopic and histological database~     for inflammatory bowel diseases patients in our medical center that will further provide~     clinical and basic investigations.~   "
175610|NCT01266525|"~     Primary Objective:~      - To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in~     comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's~     disease (AD) while on stable donepezil therapy~      Secondary Objectives:~        -  To explore the effect of SAR110894 on functional impairment, global clinical status and~          behavioral disturbances;~        -  To assess the safety/tolerability of SAR110894;~        -  To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;~        -  To explore caregiver time consumption and distress changes.~   "
175611|NCT01266512|"~     Primary Objective:~        -  Response rate (by contrast CT scan)~      Secondary Objectives:~        -  Progression-free survival (PFS)~        -  Overall survival (OS)~   "
175612|NCT01266499|"~     Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen.~     It is currently the fourth most common cause of pneumonia and fifth most common cause of~     bacteremia in intensive care patients (1-3).~      The aim of the present randomized controlled trial is to assess the efficacy of~     non-absorbable oral antibiotics in the eradication of the KPC carrier state.~   "
175613|NCT01266486|"~     Metformin, a drug that has been used since the 1950's in the treatment of diabetes, has~     recently generated great interest in its anticancer effects based on in vitro, in vivo and~     clinical studies. This study assesses the pharmacodynamic effects of metformin on breast~     cancer metabolism.~      The trial design is based on a 2 centre study 'Early Antiangiogenic Response to Bevacizumab~     in Primary Breast Cancer' that is about to successfully complete recruitment in Oxford and~     Mount Vernon hospitals. The study takes advantage of the 2 week window between the first~     clinic visit and commencement of neoadjuvant chemotherapy. Metformin will be given to~     patients for at least 2 weeks prior to neoadjuvant chemotherapy with a set of 3 breast core~     biopsies, a PET-CT scan and blood tests carried out before and after this 2 week period of~     treatment. Patients will also receive a drink of heavy (deuterated) water, a safe and stable~     isotope commonly used in clinical lipid metabolism studies, the evening prior to both sets of~     core biopsies. Having completed the first 2 weeks of metformin patients will have the option~     of continuing metformin until completion of chemotherapy, at the discretion of the trial~     physician.~      The core biopsies will then be used to assess for changes in:~        -  immunohistochemical staining;~        -  gene profiles;~        -  uptake of heavy water into tumour fatty acids using mass spectrometry techniques.~      The aim is to identify potential biomarkers of response to metformin (and other future cancer~     metabolism drugs).~   "
175614|NCT01266473|"~     The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway~     Clearance, and to investigate user experience, i.e.utility value and preference.~   "
175615|NCT01266460|"~     This phase II trial studies the side effects and how well vaccine therapy works in treating~     patients with cervical cancer that does not go to remission despite treatment (persistent) or~     has come back (recurrent). Vaccines therapy may help the body build an effective immune~     response to kill tumor cells.~   "
175616|NCT01266447|"~     This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride, and~     filgrastim or pegfilgrastim work in treating patients with persistent or recurrent cervical~     cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by blocking~     them from dividing. Giving veliparib with chemotherapy may kill more tumor cells. Filgrastim~     or pegfilgrastim may cause the body to make more blood cells and help it recover from the~     side effects of chemotherapy.~   "
175617|NCT01266434|"~     To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a~     signaling molecule for inflammation in inhaled steroid-treated asthmatics.~   "
175618|NCT01266421|"~     The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis~     therapy and of other hormonal treatments for endometriosis.~   "
175619|NCT01266408|"~     The study compares the risks of short- and long-term use of contraceptives containing~     drospirenone (DRSP) or dienogest (DNG)/ethinylestradiol (EE) plus levomefolate calcium~     (metafolin) with the risks of short- and long-term use of other established oral~     contraceptives (OCs).~   "
175620|NCT01266395|"~     Observational study to know the Impact of morning symptoms in clinical control of COPD~     patients. 1200 patients will be included by General practitioners (GPs) and pneumologists.~     Objective: establish if there are differences in the impact of COPD on daily activities and~     morning symptoms measured through questionnaires of daily life activity (Capacity of Daily~     Living during the Morning (CDLM), Global Chest Symptoms Questionnaire (GCSQ))~   "
175621|NCT01266382|"~     The purpose of the study is to examine the effect of a new biomechanical device and treatment~     methodology (AposTherapy) on gait patterns, pain, function and quality of life of patients~     with musculoskeletal and neurological disorders. Based on previous reports the investigators~     hypothesis that this therapy will have a positive effect on these measurements.~   "
175622|NCT01266369|"~     The objective is to compare efficacy and safety of AB1010 at 3 or 6 mg/kg/day in treatment of~     patients with mastocytosis with handicap and bearing activating point mutations in the~     phosphotransferase domain of c-Kit such as the main mutation Asp-816-Val (D816V).~   "
175623|NCT01266356|"~     This integrated research project is cooperated by an fully-experienced team of Taipei Medical~     University and National Institutes of Health. We hope that we can find out the disease of~     balance, anxiety and sick headaches through the translation of basic research to clinical~     diagnosis and treatment of Mild Traumatic Brain Injury (mTBI).~   "
175624|NCT01266343|"~     The investigators wanted to reported the results of immediate anterior chamber paracentesis~     (ACP), compared to Mannitol infusion, in patients with acute primary angle-closure glaucoma~     (PACG). In this study, the investigators first divided patients into three sub-groups~     according to their initial intraocular pressure (IOP) for analyzing the differences of IOP~     control, severity of corneal edema, waiting time for laser peripheral iridotomy (LPI), and~     visual outcome between ACP and Mannitol infusion.~   "
175625|NCT01266330|"~     Forty overweight and obese subjects (BMI 25-39.9) with metabolic syndrome will be randomized~     to inadequate dairy (<0.5 serving/day) and adequate dairy (3.5 servings/day) weight~     maintenance (eucaloric) diets for 12 weeks. Body weight will be measured weekly and body~     composition (via dual X-ray absorptiometry), insulin sensitivity index, plasma lipids and~     calcitrophic hormones will be measured at weeks 0, 4 and 12 of the dietary intervention.~     Oxidative burden will be assessed by measurement of plasma malonaldehyde, 8-isoprostane F2α~     and oxidized LDL and inflammatory stress will be assessed by measurement of IL-6, IL-15, MCP,~     C-reactive protein, adiponectin and TNF-α levels in plasma at 0, 1, 4 and 12 weeks). An~     additional global evaluation of diet-induced changes in cytokines will be conducted using~     cytokine protein arrays to profile relative changes in 36 additional potentially relevant~     cytokines. All data will be analyzed via two-factor (diet X obesity status) multivariate~     analysis of variance (MANOVA)~   "
175626|NCT01266317|"~     This is an open-label Phase I/II trial to assess the feasibility and safety of combined~     plasma exchange (PEX), rituximab, and conventional corticosteroid administration on the~     outcome of hospitalized patients with acute IPF exacerbations. The specific aims of this~     study are:~        1. To assess the feasibility and safety of combined PEX, rituximab, and conventional~          corticosteroid administrations for the treatment of hospitalized patients with acute IPF~          exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular function~          during the treatment interval.~        2. To assess the efficacy of combined PEX, rituximab, and conventional corticosteroid~          administrations for the treatment of hospitalized patients with acute IPF exacerbations~          on patient survival in comparison to historical controls. Patient survival for this~          investigation will be defined using the composite outcome of 60 day survival and/or~          survival to lung transplantation.~      Subjects between 18 and 80 years of age who have a confirmed diagnosis of IPF, and meet all~     the study requirements will be enrolled in this study. A total of 10 subjects of both genders~     and all ethnic backgrounds with acute IPF exacerbations hospitalized at University of~     Pittsburgh Medical Center will be enrolled in this study.~   "
175641|NCT01266122|"~     This study will develop and pilot test a combined individual and group-level behavioral HIV~     prevention intervention for men who have sex with men (MSM) in Chennai, India, addressing HIV~     risk within the context of broader psychosocial issues, including self-acceptance, substance~     use and social support.~   "
175654|NCT01265953|"~     The objective of the study is to identify mechanisms by which compounds found in cruciferous~     vegetables alter gene expression via epigenetic modifications (changes in gene expression)~     and may prevent prostate cancer development.~      The investigators have found that sulforaphane (SFN), an isothiocyanate found in cruciferous~     vegetables, inhibits histone deacetylase (HDAC) activity in human colorectal and prostate~     cancer cells.~   "
176353|NCT01256827|"~     The purpose is to assess long term vision outcomes and disease status in patients with~     age-related macular degeneration previously treated with ranibizumab as participants in the~     Phase 3 ANCHOR and MARINA Studies and the HORIZON Study.~   "
175627|NCT01266304|"~     The overall objective of this study is to develop and test an efficient self-report~     instrument to measure Complementary and Alternative Medicine(CAM)-relevant contextual factors~     important in healing.~      The initial phase of the study involves developing and refining an item bank. During the~     initial 'item bank development' phase, the investigators will run focus groups and cognitive~     interviews with individuals who participate in CAM and conventional medicine interventions.~      The current protocol in ClinicalTrials.gov pertains only to the initial phase of the study~     involving focus groups and cognitive interviews.~      The next step of instrument development is called Calibration, and will involve administering~     the revised item bank to an internet sample and to persons who receive services in a CAM~     clinic and a conventional primary care setting. The items will be calibrated using item~     response theory and classical test theory. This will result in a computerized adaptive~     testing version of the instrument, as well as a static short form of the instrument.~      The final phase of the project will involve conducting initial validation studies of the~     instrument. The instrument will be called the Healing Encounters and Attitudes List (HEAL).~     The investigators will evaluate the convergent, discriminant, and predictive validity of the~     HEAL in a sample of 200 persons with chronic low back pain who are receiving physical~     therapy, chiropractic care, or mindfulness-based stress reduction. For convergent validity,~     the HEAL is expected to display moderate to large correlations with measures of similar~     constructs. The HEAL is expected to correlate modestly with self-report measures of general~     psychosocial functioning, in support of discriminant validity. Finally, HEAL score should~     account for a significant proportion of the variance in treatment outcome, supporting~     predictive validity.~   "
175628|NCT01266291|"~     This is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin~     (Sabril) in Tuberous Sclerosis patients, a subset of the larger refractory complex partial~     epilepsy population for which the drug is approved. While enrolled on this trial, subjects~     will continue to take all of their normally prescribed medications, including their other~     antiepileptic drugs (AEDs).~      Alternatively, there is a prospective observational arm that subjects who are about to take~     Sabril as treatment for seizures associated with Tuberous Sclerosis may join. Subjects who~     join this arm will not have any study visits and will not be asked to do anything~     specifically for the study. The study team will collect all study data from subjects' medical~     records only.~   "
175629|NCT01266278|"~     Shoulder complaints are very common in overhead athletes.The application of kinesiotape that~     keeps the shoulder in a correct position is used to avoid this.~      This could enlarge the dynamic size of the subacromial space and thus contribute to~     prevention of shoulder injuries.~      30 young elite handball players will participate in this study.Researchers will perform a~     number of measurements before and after applying kinesiotape to correct shoulder position:~        -  measurement of subacromial space~        -  measurement of 3D kinematics of shoulder~        -  assessment of shoulder posture~      Hypothesis of this study is that tape can influence the position of the scapula and is~     therefore able to change the size of the subacromial space.This results in a more efficient~     use of shoulder muscles with higher maximal strength as a result and maximizes shoulder~     mobility.~   "
175630|NCT01266265|"~     A surveillance of respiratory tract related adverse events in patients treated with~     Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies~   "
175631|NCT01266252|"~     Clinical experience with dexmedetomidine in the paediatric population is limited. Critical~     illness can affect drug pharmacokinetics and -dynamics; the investigators cannot simply~     extrapolate adult data for use in children but the investigators are in need of data on~     pharmacokinetics and pharmacodynamics in every paediatric subpopulation.~   "
175632|NCT01266239|"~     In study-1, the purpose of this study is to compare the long-term outcome of provisional~     stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis~      Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal~     growth on the strut and thrombus attachment.~   "
175633|NCT01266226|"~     The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better~     and faster healing following an arthroscopic repair of the rotator cuff.~   "
175634|NCT01266213|"~     Fulvestrant is an ER antagonist with no agonist effects, which binds, blocks and degrades the~     ER. Fulvestrant is comparable to third-generation aromatase inhibitors in terms of efficacy~     and tolerability for patients who have progressed on prior tamoxifen therapy and past studies~     have found all three-third-generation AIs to be at least as good as tamoxifen in first-line~     metastatic therapy in postmenopausal women. Fulvestrant has been studied little in~     premenopausal women despite of its attractive mechanism of actions. The clinical~     effectiveness of fulvestrant as a treatment for advanced breast cancer has previously been~     demonstrated at the standard dose (AD; 250 mg/mo) in several phase III clinical trials in~     postmenopausal women. However, there is evidence to suggest that doses of fulvestrant higher~     than 250 mg may have greater pharmacodynamic activity against the ER pathway. Moreover,~     dose-dependent clinical activity has been observed for fulvestrant. The activity of a~     fulvestrant high-dose (HD; 500 mg/mo) regimen has been investigated in two recent studies. A~     pilot Japanese study showed fulvestrant HD to have clinical activity in the treatment of~     advanced or recurrent breast cancer, to be well tolerated, and to result in plasma levels~     approximately double those seen with fulvestrant low-dose. Subsequently, a neoadjuvant study~     comparing fulvestrant low-dose and high-dose reported that significantly greater Ki67 and ER~     downregulation was achieved with the high-dose compared with the low-dose regimen and that~     both doses were well tolerated. A recent randomized trial also showed superior outcome of~     high-dose fulvestrant than AI.~      Based on this rationale, we introduced high-dose fulvestrant with LHRH agonist as a~     randomized trial comparing with AI plus LHRH agonist and LHRH alone in premenopausal~     metastatic breast cancer patients who failed to tamoxifen treatment.~   "
175635|NCT01266200|"~     In this project, with unstable vertebral fractures, the microcirculation of the skin and~     muscle (O2C,Laser-Doppler/White-light -Spectroscopy and contrast-enhanced sonography) will be~     evaluated in both conventional and in percutaneous minimally invasive technique (XIA versus~     Mantis) at the thoracolumbar junction.~   "
175636|NCT01266187|"~     Is a perioperative chemotherapy based on FOLFOX and Cetuximab (K-RAS wild-type) associated~     with a higher rate of postoperative complications in patients with resectable colorectal~     liver metastases as compared to only adjuvant FOLFOX and chemotherapy? Are there any~     differences for disease free survival between periand postoperative treatment in patients~     with >3 liver metastases or at least one metastasis > or = 5 cm in diameter?~   "
175637|NCT01266174|"~     The purpose of this study is to determine if eltoprazine (as an adjunct to anti-psychotic~     medication) improves one or more aspects of cognitive impairment in adult schizophrenic~     patients.~   "
175638|NCT01266161|"~     The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide~     analgesic efficacy superior to placebo over 12-hour dosing intervals.~   "
175639|NCT01266148|"~     A controlled, randomized, open-label, multicenter study evaluating if early initiation of~     everolimus and early elimination of cyclosporine in de novo heart transplant recipients can~     improve long-term renal function and slow down the progression of chronic allograft~     vasculopathy~   "
175640|NCT01266135|"~     This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of~     QAX576 in patients with idiopathic pulmonary fibrosis.~   "
175706|NCT01265277|"~     When babies start day care, they experience many changes, some of which may affect their risk~     for sudden infant death syndrome (SIDS). The investigators want to find out if stress or~     change in the baby's sleep patterns can be a reason for this increased risk for SIDS.~   "
175642|NCT01266109|"~     Juvenile drug courts were developed in response to a perceived need to intervene more~     effectively with youth with substance abuse problems. Close collaboration between the court~     and substance abuse treatment provider is a defining component of the drug court model and is~     critical to helping youth achieve positive outcomes. Despite the proliferation of juvenile~     drug courts in recent years, however, evaluation of their capacity to reduce offender~     substance use and criminal activity has lagged. Moreover, the Institute of Medicine (IOM,~     1998) and leading experts (McLellan, Carise, & Kleber, 2003) have presented a bleak picture~     of the nation's capacity to meet the treatment needs of substance abusing individuals.~     Although community-based programs provide the backbone of substance abuse treatment in the~     nation, their capabilities have not kept up with major scientific advances in the development~     and validation of evidence-based substance abuse interventions.~      Building on our research findings and experience regarding juvenile drug court outcomes as~     well as the transport of evidence-based practices to community treatment settings, the~     purpose of this study is to develop and test a relatively flexible and low cost strategy for~     enhancing the outcomes of juvenile drug courts by integrating components of evidence-based~     treatments into existing substance abuse services.~      Specifically, this project aims to:~      Aim 1: Adapt existing intervention and training protocols from evidence-based practices~     (i.e., Contingency Management for adolescent substance abuse; family engagement strategies~     from evidence-based treatments of juvenile offenders) for integration into juvenile drug~     court sites.~      Aim 2: Conduct a study to examine youth (e.g., substance use and criminal behavior) and~     system level (e.g., intervention adherence, feasibility, retention and completion rates,~     consumer satisfaction, cost estimates) effects of implementing the intervention protocols in~     juvenile drug courts.~      Aim 3: Revise the intervention and training protocols in preparation for a Stage II study if~     findings are supportive.~   "
175643|NCT01266096|"~     Current tests to detect cancer, including CAT scans and MRI scans, are limited. PET scans use~     special dyes that are injected into a vein and can better localize possible cancer. The~     investigators have developed a new particle that can carry a radioactive dye to a very~     specific area of the tumor. When using a PET scan the radioactive dye can be viewed in areas~     of possible disease. This particle has been studied in mice and was safe.~      The particles will not treat the cancer and any images or information found during this study~     will not be used for your treatment. The information collected may be used to guide the~     design of future studies to detect and/or treat tumors.~   "
175644|NCT01266083|"~     The purpose of this study is to determine whether the WT1 vaccine causes an immune response~     which is safe and able to keep the leukemia from coming back. While vaccines have been used~     in infectious diseases like smallpox and measles,the idea about using vaccines in a cancer~     like AML/ALL is really a new use of the idea of vaccines.The WT-1 vaccine is made up of~     protein pieces that the immune system can recognize as abnormal. The doctor thinks that the~     WT-1 protein is important in AML/ALL and using some lab tests they are still able to find~     some of it in the bone marrow. By attacking this small amount of the protein they hope to get~     rid of any small amount of AML that is still in the body.~   "
175645|NCT01266070|"~     The goal of this clinical research study is to learn if dovitinib can safely be given to~     patients who have VHL with a measurable hemangioblastoma (tumor of the central nervous~     system). The effects of this drug on the disease will also be studied.~   "
175646|NCT01266057|"~     The goal of this clinical research study is to find the highest tolerable dose of sirolimus~     or vorinostat that can be given in combination with hydroxychloroquine to patients with~     advanced cancer. The safety of these drug combinations will also be studied.~   "
175647|NCT01266044|"~     The goal of this clinical research study is to learn if acupuncture can help to prevent~     xerostomia (dry mouth) and improve the quality of life in patients who receive radiation~     treatment to the head and neck. This study will determine if one acupuncture treatment~     approach is more effective than another. Dry mouth is a common problem among cancer patients~     who have received radiation treatment to the head and neck.~   "
175648|NCT01266031|"~     The goal of this Phase I portion of this clinical research study is to find the highest~     tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with~     malignant gliomas. The safety of these drug combinations will also be studied.~      The goal of this Phase II part of this clinical research study is to learn if bevacizumab~     when given with or without vorinostat can help to control malignant gliomas. The safety of~     these drug combinations will also be studied.~   "
175649|NCT01266018|"~     This was a 2-arm, open-label, phase 2 study of pegylated arginine deiminase (ADI-PEG) 20 in~     subjects with relapsed sensitive or refractory small cell lung cancer (SCLC). ADI-PEG 20 was~     administered intramuscularly (IM) at a fixed dose of 320 IU/m^2 once weekly for a 4-week~     cycle. The primary objective was to assess clinical efficacy with a primary endpoint of tumor~     response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after 4 weeks.~     Secondary objectives were to assess the safety, pharmacodynamics, and immunogenicity of~     ADI-PEG 20, as well as clinical efficacy with a secondary endpoint of overall survival.~   "
175650|NCT01266005|"~     This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy~     for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA~     negative and ALT normal) will have follow-up period for additional 48 weeks.~   "
175651|NCT01265992|"~     Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for~     the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 & 4~     Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the~     effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in~     Sweden.~      This observational study is designed to collect data to evaluate safety and effectiveness~     during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages~     3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs~     associated with patient care.~   "
175652|NCT01265979|"~     The purpose of this study is to evaluate WB DWI as early predictor of response to treatment~     with regorafenib or placebo in patients with advanced metastatic GIST.~   "
175653|NCT01265966|"~     Currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or~     if cortisol levels rise under only the most invasive of procedures, regardless of the type of~     anesthetic agent used. Animal data shows significant alterations in steroid intermediates~     under anesthesia regardless of the procedure performed. Prior studies in children show~     general anesthesia and even epidural anesthesia can cause a rise in serum cortisol, but the~     effects of moderate and deep sedation on cortisol levels during different types of procedures~     are unknown. General medical practice varies considerably among providers; some provide~     stress dosing (extra and sometimes high doses of steroids) for sedation for both non-invasive~     and invasive procedures for patients with known adrenal insufficiency, but the doses given~     vary considerably. Others provide stress dosing only for the most invasive procedures in this~     population of patients. Currently there is no published normative data on changes in cortisol~     levels under moderate and deep sedation in adrenally sufficient children, so the normal~     response we are trying to mimic is unknown.~      We propose to measure salivary cortisol levels prospectively in adrenally sufficient children~     undergoing moderate and deep sedation to determine the normal cortisol response to the stress~     of sedation for both invasive and non-invasive procedures.~      Up to 300 adrenally sufficient children will be prospectively recruited to measure salivary~     cortisol levels during moderate and deep sedation for non-invasive procedures (e.g. MRI,~     echocardiogram, or other imaging studies), and invasive procedures (e.g. surgery, endoscopy)~     to determine what the normal cortisol response is to the stress of sedation during these~     procedures using various anesthetic agents.~      The primary outcome variable will be to determine peak salivary cortisol measurements during~     non-invasive and invasive procedures under different levels of sedation using various~     anesthetic agents, and correlate these with known norms in children to determine if the~     patient's hypothalamic-pituitary-adrenal axis is under stress.~   "
175655|NCT01265940|"~     Urothelial carcinoma of the bladder mostly is chemically induced and represents the second~     prevalent urooncological disease. About 20% of newly diagnosed urothelial carcinoma cases of~     the bladder are already advanced or metastasized. Before 2008 2009 no second line therapy~     after failure of primary systemic therapy of advanced / metastatic disease was established~     outside of clinical trials. The actual standard for this situation was a supportive,~     symptomatic therapy. Vinflunine has demonstrated improved survival from 4.3 to 6.9 months~     (p=0.04), with an adequate disease control, good symptom control and with acceptable~     toxicity. Based on these results, this compound became standard se¬cond line treatment for~     refractory metastatic bladder cancer disease after failure of platinum-containing therapy. As~     the prognosis still remains poor, new treatment opportunities have to be explored.~      The target-specific therapy with Pazopanib suggests a positive influence of both inductive~     and perioperative treatment of solid tumors. Pazopanib has been approved by the FDA and the~     EMA for the treatment of advance renal cell carcinoma. Results for advanced urothelial~     carcinoma are missing so far as well as data on tolerability of the combination of both~     vinflunine and pazopanib. As the pharmacodynamic properties as well as the safety profile of~     both drugs are different, assumption is justified that there might occur additive efficacy~     effects without addition of adverse outcomes. Aim of the study thus is~        1. To define the maximum tolerated dose (MTD) of Pazopanib in combination with Vinflunine~          in a phase-I-setting and~        2. To further assess efficacy and safety of the combination at the MTD level in phase II.~      During the pase-I-part of the study different doses of pazopanib will be added to the~     standard vinflunine scheme in groups of 6 patients maximum. Dose escalation will only be~     performed in the next patient group if not more than one out of six patients shows~     dose-limiting toxicity. Each patient will be treated with the drug combination for a duration~     of two vinflunine cycles, that is six weeks.~      During the phase-II study new patients will be treated with the drug combination at~     maximum-tolerated dose until disease progression (assessed by RECIST 1.1 procedures).~   "
175656|NCT01265927|"~     A study to evaluate safety and biologic effects of giving GRN163L in combination with~     trastuzumab in patients diagnosed with HER2+ metastatic breast cancer that is resistant to~     therapy with trastuzumab.~   "
175657|NCT01265914|"~     The purpose of this study is to investigate the safety, tolerability and immunogenicity of~     ascending doses of a novel, universal flu vaccine, in healthy volunteers.~   "
175658|NCT01265901|"~     The primary objective of the phase III study is to investigate whether IMA901 can prolong~     overall survival in patients with metastatic and/or locally advanced renal cell carcinoma~     (RCC) when added to standard first-line therapy with sunitinib.~      Secondary objectives include a subgroup analysis of overall survival in patients defined by a~     certain biomarker signature, the investigation of progression-free survival, best tumor~     response, safety, and immunological parameters.~   "
175659|NCT01265888|"~     A Phase 2 open label, dose escalation study to find the minimally and maximum effective dose~     (dose beyond which no further effect on PVR is seen) of inhaled nitric oxide generated by the~     GeNOsyl® System compared to placebo.~   "
175660|NCT01265875|"~     -  To determine if intravenous secretin administration in escalating doses three times~          daily for three days will improve the pain from CP at the time of infusion, after each~          infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.~        -  To validate the safety of intravenous secretin administration at the dosage indicated in~          this study.~   "
175661|NCT01265862|"~     The investigators aim to compare two different types of supraglottic devices for tracheal~     intubation in patients undergoing elective surgery under general anesthesia.~      The investigators hypothesis is that the use of the I-gel® supraglottic airway device~     associated with a GlideRite® endotracheal tube will result in an equal success rate of~     fiberoptic tracheal intubation when compared to the LMA-Fastrach® associated with a~     GlideRite® endotracheal tube. Time to intubate with the I-gel® device should also be shorter.~   "
175662|NCT01265849|"~     The purpose of this study is to determine whether LI administered in combination with~     cyclophosphamide, indomethacin and zinc (CIZ) in a multivitamin combination prior to standard~     of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) is safe~     and will increase the overall survival of subjects with previously untreated squamous cell~     carcinoma of the oral cavity or soft palate at a median of 3 years~   "
175663|NCT01265836|"~     The purpose of this study is to establish the proportion of patients on lipid-lowering~     pharmacological treatment (statin or combination) reaching the LDL-C goals according to the~     updated 2004 National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)~     guidelines.~   "
175664|NCT01265823|"~     W11-050 is a Mexican open label multicenter study that has been designed to further assess~     the safety and efficacy of adalimumab in the treatment of patients with active plaque~     psoriasis who have failed prior conventional systemic psoriasis treatment or who are~     candidates for systemic therapy.~   "
175665|NCT01265810|"~     Targeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian~     target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high~     level of efficacy with acceptable tolerability. Currently, there are five approved targeted~     therapies available for RCC: sunitinib (Sutent®), sorafenib (Nexavar®), pazopanib~     (Votrient®), temsirolimus (Torisel®), and everolimus (Afinitor®). Hepatocellular carcinoma~     treated with sorafenib and gastro intestinal stromal tumors patients treated with sunitinib~     will be included, too.~      Since this agents have dermatological adverse events in common, with oral mucositis (OM),~     hand-foot skin reaction (HFSR) and papulopustular eruption (PPE) as an disabling side effect,~     we require evidence based management options to prevent and treat these adverse events. The~     incidence of OM of any grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus~     41%, and everolimus 44%. Recent data suggest that TKI and mTORI associated OM is distinct~     from conventional mucositis and more closely resembles aphthous OM.~      Recently, supersaturated calcium-phosphate rinse (Caphosol®), a Ca2+/PO43- mouth rinse,~     became available to prevent or treat OM.~      The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes~     which include oral intake, swallowing function and pain associated with incidence of grade ≥~     1 oral side effects and the anticancer therapy cessation in patients treated with selected~     targeted anticancer therapy.~      Patients with OM > grade 0 on targeted therapy will be randomly allocated to receive either~     Caphosol® or NaCl 0.9% rinse for two weeks. After the first rinse period all patients will~     switch to the opposite treatment arm (NaCl 0.9% or Caphosol®) for another two weeks. Duration~     of oral side effects, severity, pain, dose of analgesics and tolerability will be assessed~     weekly with the Modified-VHNSS-version-2.0 oral-specific questionnaire. Patients will be~     stratified by targeted anticancer agent and per tumor type (pre-defined cohorts). Objective~     severity of oral side effects will be assessed using the NCI-CTCAE v4.0. Correlation of~     subjective Modified-VHNSS-version-2.0 scores with the objective NCI-CTCAE grade, sex, age,~     targeted therapy type, and cancer type will be conducted.~   "
175666|NCT01265797|"~     Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain~     relief in migraine patients. However, despite the number of CES studies done, many have been~     open label, single blinded, or have utilized a small group of patients.~   "
175667|NCT01265784|"~     This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to~     assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared~     with ertapenem in the treatment of adult community-acquired complicated intra-abdominal~     infections (cIAIs).~   "
175668|NCT01265771|"~     The purpose of this study is to assess efficacy of prolonged Full Disclosure~     electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology~     to diagnose arrhythmia in comparison with standard diagnostic procedure.~   "
175669|NCT01265758|"~     The purpose of this study is to assess efficacy of prolonged Full Disclosure~     electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology~     in comparison with a standard Holter ECG recording and an Event Holter recording to diagnose~     cardiac arrhythmia.~   "
175670|NCT01265745|"~     Valortim is the name of the experimental drug that volunteers will receive in this study.~     Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by~     the Food and Drug Administration (FDA). Valortim is a monoclonal antibody (laboratory-made~     immune system molecule) for the treatment of inhalation anthrax (when the infection starts in~     the lungs). Valortim works by attaching itself to part of the anthrax toxin preventing the~     toxin from doing damage to cells. This study is being conducted to see if Valortim given over~     120 minutes is safe and tolerable. This study will take place in five parts: Screening Phase,~     Check-in Phase (the day you arrive at Quintiles to start the study), Treatment Phase (the~     time when you receive the study medication), Follow-up Phase (the time after you receive the~     study medication) and Final Visit.~   "
175671|NCT01265732|"~     This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when~     respectively given orally as a single dispersion dose and a single dose of a suspension. The~     suspension is the test formulation and the dispersion is the formulation with which the novel~     preparation will be compared.~   "
175672|NCT01265719|"~     This is a non-interventional, prospective, longitudinal cohort study. A total of 150~     pediatric subjects with glaucoma or elevated intraocular pressure, including 75~     latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will~     be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a~     non-interventional study, the study subjects' continued use of latanoprost and assessments of~     ocular events will be obtained through the routine medical follow-up with treating~     ophthalmologists or other designated members of the medical care team.~   "
175673|NCT01265706|"~     This study is performed to observe the incidence of major cardiovascular events in Korean~     patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.~   "
175674|NCT01265693|"~     The aim of the study is to assess the effect of antiviral therapy with pegylated interferon~     alpha for hepatitis C and B on auditory disability as there are reports in the English~     literature on auditory disability caused by interferon alpha.~   "
175675|NCT01265680|"~     All patients operated on at the European Hospital Heart surgery Division will be randomized~     to either single dose 80.000 UI of Human Recombinant Erythropoietin and intravenous iron or~     control.~      Primary end point is the amount of transfused blood. Secondary end point is the Hemoglobin~     level in the patient on postoperative day four.~      Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well~   "
175676|NCT01265667|"~     Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16~     weeks. All subjects will receive open-lable CF101 in weeks 17-32.~   "
175677|NCT01265654|"~     Breast cancer is the leading type of cancer in women. Although big advance in diagnostics and~     treatment of early and breast cancer has been made in recent years breast cancer still has a~     significant mortality rate. A number of treatment modalities exist for postmenopausal women~     with advanced breast cancer. The treatment modality is chosen based on patient and tumour~     characteristics. Hormonal treatment is preferred and recommended in women with hormone~     sensitive breast cancer (ESMO, CECOG and NCCN guidelines). Tumor markers are an established~     method of monitoring systemic therapies in various cancers. Tumor markers CA 15-3 and CEA are~     used in clinical practice to monitor treatment efficacy of metastatic breast cancer. Blood~     levels of tumor markers are widely used to assess response/progression to treatment and guide~     therapy change. Treatment efficacy is assessed by imaging methods in clinical studies. Change~     of therapy in clinical study is usually done when progression based on RECIST criteria is~     found. Hormonal treatment has slower onset of effect compared with chemotherapy that can last~     several weeks. Also when a new therapy is started spurious early rises may occur. Therefore~     rising levels of tumor markers during the first weeks of new hormonal therapy are not~     necessarily sign of progression and should not be the only guidance for treatment change.~     Evidence of treatment efficacy form clinical studies and treatment change is based on imaging~     techniques.~   "
175678|NCT01265641|"~     The purpose of this research study is to evaluate the effect of AZD1981 on the electrical~     activity of the heart, in particular when the heart muscle is relaxed during a heart beat~     cycle. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which~     is well known to affect the electrical activity of the heart, but this effect is known to be~     at levels that are safe at the dose used in this study. The investigators will also compare~     the effects of AZD1981 with a dummy drug (placebo). The investigators will also be~     evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters the blood~     circulation by collecting blood during the study.~   "
175679|NCT01265628|"~     Comparison of the differential luminance sensitivity (DLS) values at each test point~   "
175680|NCT01265615|"~     We hypothesize that paricalcitol and calcitriol in dose-dependent manner are effective for~     the management of chronic allograft dysfunction (CAD), protection and repair of kidney and~     heart, management of chronic renocardiac syndrome (CRS). We assume that paricalcitol can have~     some advantages if compare with calcitriol or cholecalciferol due to absence of calcemic and~     phosphatemic complications alongside with great beneficial potential.~   "
175681|NCT01265602|"~     The aim of this study is to determine the efficacy, safety and tolerability of LAS41007~     compared to a marketed reference product as well as to vehicle (topical application, twice~     daily, indication mild to moderate AK).~   "
175682|NCT01265589|"~     To research the effect of vitamin A to newborn respiratory distress syndrome by intratracheal~     administration with surfactant.~   "
175683|NCT01265576|"~     The purpose of this study is to determine if VT-122 provides a clinical benefit when added to~     Sorafenib in patients with advanced hepatocellular carcinoma (HCC).~   "
175684|NCT01265563|"~     The study is done to find out whether the combined use of the nutritional supplements~     N-acetylcysteine and Siliphos (milk thistle extract) corrects the shedding of urine protein~     and oxidative damage (damage to cells and organs often compared to fast aging) in patients~     with Type 2 Diabetes Mellitus (T2DM) and diabetic kidney disease.~   "
175685|NCT01265550|"~     Background: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult~     Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors~     (PPIs), which block gastric acid production, are the most effective medications for GERD, and~     the VA spends more than $177 million each year on outpatient PPI prescriptions. PPIs do not~     prevent the reflux of non-acidic material and do not completely eliminate esophageal acid~     exposure, however, and bothersome GERD symptoms persist in approximately 40% of patients~     treated with PPIs. Recent studies using the new technique of esophageal pH/ impedance~     monitoring, which detects the reflux of both acidic and non-acidic materials, have shown that~     PPI-resistant GERD symptoms correlate with episodes of reflux (acidic and/or non-acidic) in~     approximately one-half of patients. For those patients, an antireflux operation might relieve~     symptoms and obviate the expense of ineffective PPI therapy, but the efficacy of modern,~     laparoscopic fundoplication in this regard is not clear. For patients with PPI-resistant GERD~     symptoms, furthermore, the efficacy of medications that that can prevent gastroesophageal~     reflux (e.g. baclofen) or diminish pain of esophageal origin (e.g. neurotropic agents like~     desipramine) also is not clear. Study Hypothesis: Laparoscopic antireflux surgery (Nissen~     fundoplication) is superior to medical therapy (PPIs plus baclofen and desipramine) for GERD~     patients who, while on PPIs, have persistent episodes of heartburn that are associated with~     reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance~     monitoring.~      Study Goals: The primary goal is to compare the efficacy of laparoscopic Nissen~     fundoplication and medical therapy (PPIs plus baclofen and desipramine) for GERD patients~     who, while on PPIs, have persistent episodes of heartburn that are associated with reflux~     episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring, and~     to compare the efficacy of each therapy with placebo. Secondary goals are: 1) To determine~     the frequency with which non-GERD disorders underlie PPI failure, 2) To determine the~     frequency of functional gastrointestinal symptoms, anxiety and depression in patients who~     have persistent heartburn while on PPIs, 3) To determine whether functional gastrointestinal~     symptoms, anxiety and depression is associated with the outcomes of medical and surgical~     therapies, and 4) To determine whether the outcome of Nissen fundoplication is associated~     with adherence to technical aspects of the operation.~      Study Design: At 15 VA medical centers, there will be a 30-month recruitment period to enroll~     393 patients with heartburn that is refractory to PPI therapy. Patients will have their~     baseline GERD symptoms scored using the GERD Health-Related Quality of Life (GERD-HRQL)~     index, and will have endoscopy, esophageal manometry and esophageal pH/impedance monitoring~     while on PPI therapy. Patients who have episodes of heartburn that are associated with reflux~     episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring will~     be randomized to one of three treatment groups: Surgical Treatment (laparoscopic Nissen~     fundoplication), Active Medical Treatment (omeprazole and baclofen initially; desipramine for~     baclofen failures) or Placebo Medical Treatment (omeprazole, placebo baclofen, placebo~     desipramine). All patients will have quarterly clinic visits for symptom scoring and~     laboratory testing. At one year, patients will have a final symptom scoring and repeat~     endoscopy, esophageal manometry and esophageal pH/impedance monitoring. Treatment success~     will be defined as 50% improvement in the GERD-HRQL score at 12 months. Patients also will~     complete the Hospital Anxiety and Depression Scale (HADS), Rome III Functional GI Disorders~     Questionnaire and the Short-Form Health Survey (SF-36) at baseline and one year. The results~     will be correlated with treatment outcomes.~   "
175686|NCT01265537|"~     While the incidence of acute rejection and early graft loss have improved dramatically with~     the advent of newer immunosuppressant medications, improvements in long-term patient and~     allograft survival after kidney transplantation have not been achieved. The specific drug~     combination that provides the best outcomes with the least amount of side effects is not~     known. Each kidney transplant center uses the combination of drugs that they believe is~     optimal. This study is about identifying whether drugs that are currently approved for use in~     kidney transplantation can be used in a new combination safely and with potentially fewer~     side effects than the drug combinations that are currently used at St. Paul's Hospital and~     other transplant centres.~   "
175687|NCT01265524|"~     The purpose of this study is to determine the effects of CLP on serum potassium and signs and~     symptoms of fluid overload in heart failure patients with chronic kidney disease.~   "
175688|NCT01265511|"~     This study will examine the effectiveness of 28 days of triple combination therapy including~     SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An~     additional 20 weeks of treatment with the currently approved standard of care will be offered~     to all participants. The Week 24 visit will be the last on-study visit. After the Week 24~     visit, all subjects with undetectable HCV RNA will be given the option to continue treatment~     with standard of care for an additional 24 weeks (out to Week 48) under the care of their~     Principal Investigator.~   "
175689|NCT01265498|"~     Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks~     to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in~     improvement in their liver disease as measured by changes in the nonalcoholic fatty liver~     disease (NAFLD) activity score (NAS).~   "
175690|NCT01265485|"~     This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be~     participating in this study. This study is composed of 2 parts:~      Part 1 is a dose finding study. Part 2 is a pharmacodynamic and pharmacokinetic study of an~     elected dose. A screening will be used to determine patients' suitability for inclusion in~     the trial. Within one week after the screening visit, subjects who meet all inclusion~     criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose~     escalation. During this part, patients will undergo rectal manometry to determine anal~     pressure at baseline. Afterwards coated suppositories at various drug concentrations will be~     inserted and follow up manometries will be performed to determine response.~      Patients that presented with an increase in rectal resting pressure without adverse events~     will enter the second part of the study. In this part, patients will be administered with a~     coated suppository, at a dose found at part 1 of the study to cause significant anal~     contraction. Manometry studies will be performed before insertion (baseline) and at 1, 3 and~     5 hours after insertion.~      Blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes~     after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after~     administration.~   "
175691|NCT01265472|"~     Translocator protein (TSPO) is a intracellular protein that is found primarily in the outer~     membrane of the mitochondria that is encoded by the TSPO gene. It has been found that TSPO~     expression in the skin correlates with cell proliferation and differentiation. Many studies~     have shown that TSPO overexpression in solid malignancies such as in ovarian cancer, colon~     cancer, and others, was also found to correlate with more aggressive cancer behavior. Working~     Hypothesis and Aims: Previous studies described an aberrant expression of TSPO levels in~     solid malignancies as compared to normal tissues. It is assumed that this aberration can be~     found in cuntaneous malignancies as well. The occurrence of this aberration may lead to the~     understanding of the mechanism of TSPO involment in the cutaneous malignancy, and in~     malignancies in general. Methods: The study will be carried out on surgically resected skin~     lesions suspected to SCC or BCC, which will be removed as part of the surgical routine~     treatment. The excision will be made in elliptic shape including the lesion and a part of~     normal skin surrounding it. A sample will be taken from the central part of the lesion and~     from the external extremity of the normal tissue. Western Blot will be conducted to detect~     the expression of TSPO. Binding activity with the TSPO specific ligandwill also be~     determined. Expected Results: We expect to observe either (a) a higher level of TSPO~     expression and a lower binding activity in malignant tissue compared with healthy control~     tissue or (b) a higher level of TSPO expression and a lower binding activity in malignant~     tissue compared with healthy control tissue. Importance: Until today, only a very small~     number of studies have examined TSPO in cutaneous malignancies, and these only examined TSPO~     expression. Our study will also measure the binding activity of TSPO in cutaneous malignant~     tissues compared to normal tissues~   "
175692|NCT01265459|"~     The purpose of the study is to assess the safety and efficacy profiles of new~     single-injection volumes of Durolane in patients with knee OA.~   "
175693|NCT01265446|"~     This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg +~     cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg~     lozenge in the treatment of sore throat due to a common cold.~   "
175694|NCT01265433|"~     The doctors are testing a Wilms Tumor-1 (WT1) vaccine to see if it delays or prevents the~     mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates~     gene expression and causes cell growth. Mesothelioma tumors generally have high levels of~     WT1.This study was originally designed to have two treatment groups. One group received~     non-specific immunotherapy with medications called Montanide and Sargramostim (Granulocyte~     Macrophage Colony Stimulating Factor, GM-CSF). Enrollment to this group has stopped The other~     group, which continues receives more specific immunotherapy with the WT1 vaccine plus~     Montanide and GM-CSF. Both Montanide and GM-CSF are commonly given along with vaccines~     because they have a general effect in boosting the immune response. Some researchers believe~     that this general increase in the immune system may have some effect in treating cancer. Some~     studies using GM-CSF with melanoma vaccines have suggested that it could lessen the effects~     of the vaccine. The addition of the WT1 proteins makes this therapy more directed to~     mesothelioma. The combination of WT1 vaccine with Montanide and GM-CSF has been tested in a~     prior trial including 9 patients with advanced mesothelioma. In that trial, the vaccine was~     safe and caused an immune response.~   "
175695|NCT01265420|"~     This study will evaluate the efficacy and safety of clostridial collagenase injections for~     treatment of Dupuytren's contracture of the thumb and first web space. The investigators~     hypothesis is that clostridial collagenase will have safety not significantly different to~     that demonstrated in Phase III clinical trials, and will be effective in significantly~     reducing the degree of thumb contracture.~   "
175707|NCT01265264|"~     The purpose of this study is to determine whether ulodesine and allopurinol combined for 12~     weeks are effective in treating gout in patients who are not adequately responding to~     allopurinol alone.~   "
175708|NCT01265251|"~     A computerised neuropsychological test battery to be used as a standardised tool assessing~     the cognitive domains affected by idiopathic normal pressure hydrocephalus INPH was~     developed. The aim of this study is to investigate the reliability, validity and feasibility~     of the battery.~   "
175696|NCT01265407|"~     Background:~      - Malaria is a leading cause of morbidity and mortality in Uganda, accounting for more than a~     quarter of all outpatient visits at health facilities, 20 percent of hospital admissions, and~     about 10 percent of inpatient deaths. Children under 10 years of age, pregnant women, and~     HIV-infected individuals bear the greatest burden of disease. To provide baseline information~     for future malaria vaccine research, development, and testing, researchers are interested in~     collecting malaria infection data from the Rakai district in southern Uganda.~      Objectives:~      - To assess the epidemiology of malaria infection among children aged 6 months to less than~     10 years and adults living in same households with children in Rakai district, Uganda.~      Eligibility:~      - Children between 6 months and 10 years of age, as well as their primary caregiver and an~     additional randomly selected adolescent or adult resident of the household, from the Rakai~     district of Uganda.~      Design:~        -  Participants will have monthly household visits for a 1-year surveillance period.~        -  Each visit will include a structured interview/questionnaire of the primary caregiver or~          legal guardian of the child and clinical and laboratory assessments of each child, the~          primary caregiver, and the additional adolescent or adult resident of the household. The~          questionnaire will ask about malaria treatment and prevention measures.~        -  Children will provide a blood sample for testing. Individuals (children or adults) who~          are diagnosed with malaria or anemia during the course of the study will be recommended~          for treatment.~        -  Researchers will also track usage of the district health clinic and hospital services to~          link medical records for study participants.~   "
175697|NCT01265394|"~     Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD).~     The study drug helps produce pictures of amyloid in the brain. The purpose of this study is~     to determine how well the study drug performs in young healthy subjects.~   "
175698|NCT01265381|"~     Background:~      - The Ukrainian Research Center for Radiation Medicine and the U.S. National Institutes of~     Health have been studying cancer risks and outcomes in individuals who participated in the~     decontamination clean-up process following the Chornobyl nuclear accident. Some of these~     individuals were exposed to external radiation at various levels, as well as radioactive~     iodine that may have affected the thyroid and increased the risk of developing thyroid~     cancer. Because more individual and comparative data are needed on the affected populations~     and clean-up workers associated with the Chornobyl accident, researchers are interested in~     collecting personal information and saliva samples from Chornobyl clean-up workers who have~     been diagnosed with thyroid cancer.~      Objectives:~      - To assess the radiation-related risk of thyroid cancer among male Chornobyl clean-up~     workers and collect saliva samples for an initial study.~      Eligibility:~      - Male Chornobyl clean-up workers from Kyiv and Donetsk oblasts who have been diagnosed with~     thyroid cancer.~      Design:~        -  Participants will complete a standardized questionnaire during a personal interview. The~          questionnaire will ask for detailed information on the following areas of study:~        -  Work history, conditions, and activities inside the 70-km clean-up and radiation~          calculation zone.~        -  Residence history inside and outside the 30-km exclusion zone.~        -  Milk consumption between April 26 and June 30, 1986 (to assess radioactivity from~          radioiodine fallout).~        -  Potential non-radiation risk factors for thyroid cancer (e.g., smoking, alcohol~          consumption, family cancer history).~        -  Participants will provide a saliva sample for pilot study testing.~   "
175699|NCT01265368|"~     This is a Phase 1/2, proof-of-principle clinical study to assess safety and efficacy of a~     intradermally administered tumor vaccine (MGN1601). The study will be conducted in patients~     with advanced renal cell carcinoma.~   "
175700|NCT01265355|"~     Rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. The~     investigators hypothesize that use of a food based prophylactic will decrease incidence of~     rotavirus infection in young children in south India, prevent intestinal damage and overall~     result in lower infection rates and better gut function. This trial will evaluate the~     efficacy of prevention of rotavirus gastroenteritis when an anti-rotavirus protein or~     antibody fragments expressed in yeast or placebo are given daily as a food supplement to~     children between the ages of 6 and 12 months. The children will followed for one year and~     rates of rotavirus diarrhoea, antibody responses and gut function will be compared between~     children receiving antibody fragments or placebo.~   "
175701|NCT01265342|"~     Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic~     treatment of upper respiratory infections without evidence of efficacy.~      The purpose of this study is to evaluate the efficacy of beclomethasone (administered by~     nebuliser twice a day) in preventing viral wheezing in pre-school children who had had~     episodes in the preceding 12 months.~   "
175702|NCT01265329|"~     In spite of the achievements and developement of the assisted reproduction techniques in the~     last years, there is still an elevated percentage of unsuccessful treatments, needing~     sometimes repeated attempts to reach pregnancy.~      The molecular physiology of sperm is being better characterized, and some reports have~     demonstrated the implication of different molecular processes in the pathophysiology of male~     infertility.~      Recently, different sperm selection methods have been based on these molecular differences,~     showing a better quality of the sperm population after selection.~      The main objective of this research project is to clinically apply these techniques in order~     to increase the pregnancy rates per cycle in infertile couples attending assisted~     reproduction treatments.~   "
175703|NCT01265316|"~     Outcomes for pediatric cardiopulmonary resuscitation (CPR) are suboptimal. CPR quality is~     directly related to resuscitation outcome, yet numerous deficiencies in CPR quality have been~     documented in adult studies. While similar deficiencies can be expected in pediatric~     resuscitation attempts, there is little to no data evaluating the existing quality of CPR~     performed during resuscitation attempts. Therefore, the objective of this study is to~     quantitatively evaluate existing CPR quality using a Q-CPR compression sensor manufactured by~     Philips Medical Systems with technology from Laerdal Medical.~   "
175704|NCT01265303|"~     The purpose of this study is to assess efficacy of prolonged Full Disclosure ECG monitoring~     and signal analysis using advanced GSM telemetric technology to prescribe the most~     appropriate treatment of arrhythmia.~   "
175705|NCT01265290|"~     The purpose of this study is to assess efficacy of prolonged Full Disclosure~     electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology~     to diagnose syncope in comparison with standard diagnostic procedure~   "
175709|NCT01265238|"~     Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments~     may include physical therapy, orthosis, botulinum toxin (BTX) injections, selective tibial~     neurotomy and tendon lengthening and/or transfer.~      Until now, no study has been conducted to assess the result of neuro-orthopaedic surgery in~     the treatment of SEF.~      The aim of this study is to evaluate the benefit of neuro-orthopaedic surgery (selective~     neurotomy and/or Achilles tendon lengthening and/or tibialis anterior transfer) in case of~     SEF according to the 3 domains of the International Classification of Functioning, Disability~     and Health (ICF)of the World Health organisation (WHO)~   "
175710|NCT01265225|"~     The goal of the investigators study is to identify a prognostic marker that will evaluate the~     probability of recurrence in patients with stage 0-II breast cancer following surgery to~     remove the tumor.~   "
175711|NCT01265212|"~     HPV infection is associated with cervical and other anogenital cancers. HPV may also be~     associated with the development of prostate cancer. The purpose of the study is to determine~     the prevalence of HPV infection in men living in South Dakota.~   "
175712|NCT01265199|"~     The main purpose of this study are to determine the maximum dose of AT-406 that can be safely~     given in combination with cytarabine and daunorubicin to humans. Other purposes are to~     determine how the drug is broken down in the body, and to see if there are any molecular~     interactions that can help determine how AT-406 works. Side effects will also be studied in~     an effort to make sure that this drug is safe to take.~   "
175713|NCT01265186|"~     Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to~     numerous painful procedures and often dependent on mechanical ventilation. Mechanical~     ventilation as well as painful conditions require a sufficient analgesia and or an accurately~     regulated sedation. Newborns incapable of self-report are therefore dependent on the~     assessment of the infants level of pain and sedation by the treating team.~      The aim of this prospective, controlled, observer-blinded clinical trial is to compare the~     performance of two EEG based methods and a clinical sedation scale to measure the level of~     sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are~     compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation~     between the clinical sedation score (N-PASS), the bispectral index (BIS) and the~     amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen~     control patients are enrolled and observed for up to 72h.~   "
175714|NCT01265173|"~     Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver~     cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several~     antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear~     which drug is most effective. Our aim of study is to compare the efficacy of the three~     current antibiotics for the treatment of SBP in patients with liver cirrhosis.~      The primary hypothesis is that the efficacy of all the antibiotics will not significantly~     different. This is non-inferiority trial.~   "
175715|NCT01265160|"~     Jiangzhuo prescription ,fenofibrate and placebo in the treatment of hyperlipidemia(syndrome~     of phlegm obstruction), randomized, parallel-controlled, multi-center clinical study~   "
175716|NCT01265147|"~     This phase II trial is studying cisplatin or nedaplatin combine with IMRT to evaluate which~     one is better efficacy and security in nasopharyngeal carcinoma.~   "
175717|NCT01265134|"~     The purpose of this study is to measure the ability of balance controlling and test the~     evaluation of clinical trials with different arch insoles. The investigators want to find out~     the difference and efficacy of arch insoles in the dynamic postural control for the elderly.~   "
175718|NCT01265121|"~     Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This~     disease is linked to disturbance on the carbohydrate metabolism increasing the rates of~     diabetes. The objective of this trial is to assess (with the euglycemic hyperinsulinemic~     clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure~     device (CPAP), on the insulin resistance.~   "
175719|NCT01265108|"~     During alveolar hypoxia, for example at high altitude or in patients with respiratory~     disease, there is evidence to suggest that hypoxia-induced pulmonary hypertension might limit~     exercise performance. Intravenous iron supplementation has recently been shown to reverse~     pulmonary hypertension in healthy humans at high altitude, and to prevent pulmonary~     hypertension in volunteers exposed to hypoxia at sea level. The investigators hypothesized~     that intravenous iron supplementation would enhance exercise capacity during alveolar~     hypoxia.~   "
175720|NCT01265095|"~     The investigators hypothesized that quantitative PCR can be used in VRE bacteremia outcome~     monitoring. Vancomycin-resistant enterococci (VRE) was first found in 1988 and has become an~     important healthcare-associated pathogen due to rapid spread, limited options for therapy and~     the possibility of transferring vancomycin resistance to more virulent pathogens. VRE~     infections not only contribute to more hospital cost and longer length of hospital stay, but~     also higher attributable mortality compared to those caused by vancomycin susceptible~     enterococci. Two different meta-analyses have shown that vancomycin resistance is an~     independent predictor of death among patients with enterococcal bloodstrem infections (BSIs).~     Despite this, few effective antibiotics are approved by the US Food and Drug Administration~     for the treatment of serious VRE infections. Though several studies have conducted to find~     the possible mortality predictors, but none has used bacterial load as a marker.~      Schonheyder et al. have used semiquantitative culture, and demonstrate the relationship~     between high bacterial load and mortality. However, it may take more than two days before~     culture result available, and the sensitivity of culture is greatly affected by antimicrobial~     treatment. Real-time PCR has been demonstrate good performance in early detection of~     bacteremia, and theoretically is less affected by antimicrobial usage. However, using~     quantitative real-time PCR to quantify VRE in blood has not been explored, yet.~      The objective of this study is to establish a quantitative method to measure the amounts of~     VRE in blood using the VRE specific van gene. And test the hypothesis that higher VRE load in~     blood results in higher mortality among patients with VRE BSIs.~      Primers and probe of VRE Real-time PCR will be constructed first. The investigators will~     prospective enroll patient with VRE bacteremia. Clinical data and outcome will be monitored.~     Bacteria load of VRE bacteremia will be measured via established real-time PCR. The outcome~     and the association of bacteria load of VRE bacteremia will be analyzed.~   "
175721|NCT01265082|"~     The following is the investigators hypothesis regarding the pruritus of BP patients during~     remission. Anti-BP 180 IgE binds to dermal mast cells, inducing their activation and~     secretion of mediators after being cross-linked by antigens. Among mediators, histamine~     directly induces itching and vessel changes, whereas tryptase potentiates itching and vessel~     changes in an indirect way through the actions of neuropeptides. Tryptase stimulates neurons~     which in turn secrete neuropeptides.~   "
175818|NCT01263821|"~     RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor~     definition, thus may lead to better tumor targeting and avoid damaging critical parts of~     normal brain.~      PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating~     patients with newly diagnosed intracranial glioma.~   "
175722|NCT01265069|"~     Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to~     the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To~     our knowledge, there has been no report concerning the efficacy of this regimen used as a~     rescue therapy.~      The aims of this study are:~        1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue~          regimen in H. pylori eradication;~        2. to compare the patient adherence and adverse effects of these treatment regimens;~        3. to investigate factors that may influence H. pylori eradication by these treatment~          regimens.~   "
175723|NCT01265056|"~     Burn patients have extreme pain. Opioids are the main agents used for analgesia. We therefore~     propose a single center study to fruther assess the efficacy of neuropathic agents in~     controlling the pain associated with acute thermal injury.~   "
175724|NCT01265043|"~     The main aim of this oral health intervention project is to compare the effect of providing~     1) professional oral hygiene instruction alone versus 2) professional oral hygiene~     instruction plus adjunctive Chlorhexidine mouth rinse versus 3) professional oral hygiene~     instruction plus adjunctive assisted tooth brushing and Chlorhexidine mouth rinse, on the~     oral health condition, the general health condition and health-related quality of life~     (HRQoL) of patients with stroke who are receiving hospital-based rehabilitation. An~     additional aim is to assess potential longer term oral intervention-related health and HRQoL~     outcomes.~   "
175725|NCT01265030|"~     Desmoid-type fibromatosis (or desmoid tumor) represents an intermediate grade neoplasm with a~     striking predilection for locally invasive growth and recurrence following resection. It~     occurs in children as well as young adults. As a typically localized disease, the historical~     standard of care for treatment has been surgical resection, with or without ionizing~     radiation. In some cases where surgical resection or radiation is not feasible, chemotherapy~     has been used. Two clinical trials conducted in the Pediatric Oncology Group (POG) and the~     Children's Oncology Group (COG) evaluated the role for either low intensity or non-cytotoxic~     chemotherapy for children with desmoid tumor that is not amenable to standard therapy. These~     were largely empirical treatment strategies or based on somewhat anecdotal observations. By~     better understanding desmoid tumor biology, even more effective therapy targeting a~     particular protein that is central to the disease can be developed.~      Desmoid tumor is well-known to be associated with deregulation of the Adenomatous Polyposis~     Cell/beta-catenin (APC/β-catenin pathway). This is true of familial cases associated with~     Gardner's Syndrome and also in sporadic desmoid tumor, nearly all of which display~     histological or molecular evidence of Adenomatous Polyposis Cell/beta-catenin (APC β-catenin)~     pathway activation (Alman et al., 1997; Lips et al., 2009). Several new pieces of evidence~     support the concept that deregulation of the mammalian target of rapamycin (mTOR) cell~     proliferation/survival pathway may play an important role in tumor biology when the~     APC/β-catenin pathway is disrupted. Sirolimus, a drug that inhibits mammalian target of~     rapamycin (mTOR), is currently being evaluated as an anti-cancer agent in a variety of tumor~     types, but it has not been previously studied in desmoid tumor.~      The investigators are conducting this pilot study to begin to explore whether mTOR inhibition~     may be beneficial for children and young adults with desmoid tumor.~   "
175726|NCT01265017|"~     This is a randomized, double-masked, placebo-controlled, single-center study to evaluate~     stimulated C-peptide secretion after exogenous administration of mild immunosuppression and~     growth-promoting factors to women with preexisting T1DM who had a decline in insulin~     requirement or had detectable C-peptide during a previous pregnancy. Fifteen subjects will be~     enrolled and randomly assigned in a 2:1 ratio to either active treatment or placebo in a~     parallel group design.~      Participation for individual subjects will consist of an initial Screening Visit, a 2-week~     baseline period, a Baseline Visit, visits at week 2 and 4 of the treatment period, a visit at~     the end of the treatment period (week 6), and a follow-up visit 2 weeks after study treatment~     discontinuation.~      Subjects will receive either active treatment or matching placebo of estradiol 1 mg every 8~     hours; medroxyprogesterone 2.5 mg every 24 hours; hydrocortisone 2.5 mg every morning, 1.25~     mg every afternoon, and 1.25 mg at bedtime each night; and growth hormone 2 mg once a day).~   "
175727|NCT01265004|"~     This project investigates microcirculation in skin and tendon after a rupture of the Achilles~     tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the~     combination of both.~   "
175728|NCT01264991|"~     BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and the knee is one of~     the most affected joints. The meniscus plays an important role in the development of knee OA.~     It is unclear whether a degenerative meniscus tear is a risk factor in developing knee OA or~     a sign of the disease. The standard treatment for a degenerative meniscus tear is an~     arthroscopic partial meniscectomy (APM). There is strong evidence that this puts the knee at~     high risk of later developing OA. Earlier studies have shown a significant placebo effect~     from surgical procedures, in general, and an arthroscopic knee procedure, in particular.~      PURPOSE The overall purpose of this study is to gather information that might lead to a~     reduction in the development of OA in middle-aged patients. The investigators hypothesise~     that the benefit from an arthroscopic partial meniscectomy is due to the placebo effect~     measured on self-reported outcomes, and that the meniscectomy contributes to the development~     of knee OA as seen on radiography.~      METHODS The investigators will include 100 patients aged from 35 to 55 years with an~     MRI-confirmed medial meniscus tear and without knee OA (excluding patients with Grade 3 or 4~     knee OA on the Kellgren-Lawrence classification). Participants will be randomised to either a~     standard APM procedure or a sham procedure and both groups will receive standard~     post-operative care. The primary outcomes will be a self-reported questionnaire, the KOOS~     score, and a functionality test after 3 and 24 months.~   "
175729|NCT01264978|"~     The aims of this study are:1.To evaluate the utility of quadriceps RMNMS (repetitive magnetic~     neuromuscular stimulation) in the evolution of COPD patients after hospital admission for~     acute exacerbation.2 To evaluate the time schedule of recovery changes in muscle parameters~     ,exercise capacity and quality of life after acute exacerbation. 3.To test the use of this~     new method of training in acute clinical situations. Patients: COPD patients admitted to the~     Hospital with acute exacerbation. Group 1: RMNMS Treatment .Group 2 : sham RMNMS treatment.~     Randomized assignment by minimization method. PROTOCOL Training Group: 10 days after~     discharge and during 8 weeks, 2-3 days/week.~      Measures: Spirometry, Plethysmography ,Diffusion Test. Main outcomes: Exercise test (Six~     minutes walking distance). Muscle function: MVC. Health related quality of life.~   "
175730|NCT01264965|"~     To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older~     persons with no and mild to moderate cognitive impairment and persistent moderate or higher~     intensity non-cancer lower extremity arthritis pain; and Describe the association of change~     in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and~     brief physical performance measure) and to determine if cognitive status modifies this~     relationship.~   "
175731|NCT01264952|"~     The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with~     bleomycin in treatment of liver metastases of colorectal cancer in clinical study phase I and~     II.~      The study will include 10-15 patients with colorectal cancer with synchronous or metachronous~     liver metastases, but electrochemotherapy will be performed on metastasis not more than 3 cm~     in the largest diameter.~      Treatment effectiveness will be evaluated by magnetic resonance imaging (MRI) and~     ultrasonography (US) in a monthly interval. Two or three month after the first operation the~     treated and untreated metastases will be resected and through histological analyses~     performed.~      The secondary objectives of the trial are to quantify the impact of the treatment on the~     patient's quality of life, tolerance to the therapy and suitability for larger study to be~     conducted.~   "
175732|NCT01264939|"~     The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled,~     parallel-group study to evaluate the safety and efficacy of omalizumab administered~     subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged~     12-75 who have been diagnosed with chronic idiopathic urticaria (CIU) who remain symptomatic~     despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the~     approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).~   "
175733|NCT01264926|"~     The Objective is to evaluation the difference between the upper end of the Humerus head and~     the bottom end of the Acromion in sitting and lying, and to examine this difference to~     shoulder pain.~   "
175734|NCT01264913|"~     The overall goal of the present application is to test the hypothesis that shift workers, who~     are chronically exposed to circadian misalignment and sleep loss, have a higher~     cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of~     circadian misalignment both predict their elevated cardio-metabolic risk.~   "
175735|NCT01264900|"~     Aggressive behavior is a leading worldwide public health problem. Despite this, relatively~     little is known about how to best treat individuals who are highly angry and aggressive. A~     rich literature suggests that aggression is associated with a tendency to interpret~     situations as threatening or hostile even when they are not. This process is governed by a~     prefrontal-limbic circuit in the brain. A goal of cognitive behavioral therapy is to reduce~     these kinds of hostile biases. Preliminary data by the PI suggests a 12- session cognitive~     behavioral aggression treatment (CBAT) may help reduce aggressive behavior and underlying~     hostile biases associated with affective aggression. To assess the efficacy of this~     treatment, 120 adults with high levels of anger and aggression will receive 12 sessions of~     either CBAT or supportive psychotherapy. All subjects will monitor their anger and aggressive~     behavior throughout the treatment electronic diaries. Subjects will also complete~     questionnaires and computer tasks to assess anger, hostile biases and related processes~     1-week before treatment begins, and again 1-week, 6-months and 1-year after treatment ends.~     In addition, to understand the effects of CBAT on the brain, subjects will have their brains~     scanned (functional Magnetic Resonance Imaging) while they look at emotional pictures and~     complete computer tasks. The brain scans will occur once before treatment starts and once~     after treatment ends.~      Our hypotheses are:~        1. CBAT will reduce anger, aggression and hostile biases more than supportive therapy.~        2. CBAT will decrease limbic activation and increase prefrontal activation to emotional~          pictures more than supportive therapy.~   "
175736|NCT01264887|"~     The purpose of this trial is the characterization of the long term safety profile and~     long-term dose requirements of tapentadol PR (prolonged release) in patients with malignant~     tumor-related pain. In the United States the prolonged-release formulation is also referred~     to as the extended-release formulation.~   "
175737|NCT01264874|"~     The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence~     in resected stage II melanoma patients.~   "
175738|NCT01264861|"~     This is a study of safinamide, an investigational drug for Parkinson disease (PD). Safinamide~     is being developed as add-on therapy for the treatment of Parkinson disease. It is theorized~     that safinamide acts by increasing the available dopamine in those areas of the brain where~     dopamine is decreased as a result of Parkinson;s Disease. . Dopamine in the brain is involved~     in controlling body movements. Safinamide has been extensively studied in animals, and has~     been shown to increase the level of dopamine in these animals. Safinamide has also been~     tested in patients with Parkinson disease. The goal of this research trial is to see if~     safinamide is safe and well tolerated and to better understand how it affects the dopamine~     system in the brain in individuals with Parkinson disease. Data from this trial may provide~     essential information about the effectiveness and safety of these doses of safinamide in~     patients with early Parkinson disease, who are already receiving a stable dose of their~     normal Parkinson disease treatment.~   "
175739|NCT01264848|"~     The aim of this study is to assess the efficacy of endovascular treatment (balloon~     angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis~     patients.~   "
175740|NCT01264835|"~     This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration)~     and post-operative patient outcomes (e.g., pain)following a modified Ferguson~     hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.~   "
175741|NCT01264822|"~     To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori~   "
175742|NCT01264809|"~     The prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide,~     in France and especially in the French West Indies.This chronic disease is associated with~     premature mortality and various debilitating complications which can be prevented by optimal~     control of glycaemia, blood pressure and lipids. Diabetes management includes lifestyle~     modification and medication. Despite numerous studies supporting the benefits of frequent~     physical activity for people with Type 2 diabetes, an estimated 60±80% of this population~     remain sedentary. Promotion of physical activity in current diabetes care seems to be~     inadequate.~      The aim of this randomized controlled trial is to evaluate the medium-term effectiveness~     (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients~     with Type 2 diabetes.~   "
175819|NCT01263808|"~     This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral~     moxifloxacin.~   "
176404|NCT01256164|"~     The purpose of this study was to characterize the safety and hemostatic activity of topical~     Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical~     techniques was ineffective and/or impractical.~   "
175743|NCT01264796|"~     The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a~     comprehensive, culturally tailored DM management intervention, in improving glucose outcomes;~     To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving self-care~     skills and psycho-behavioral outcomes related to DM control, to develop tangible~     infrastructures for the dissemination of valid and effective education materials to a wider~     population of KAI with type 2 DM in the US (e.g., audio-visual education materials, web-based~     intervention materials, mobile telephone-based intervention materials) and to explore the~     feasibility and acceptability of each dissemination module, utilizing the delayed~     intervention group participants. The secondary aims are to obtain preliminary~     cost-effectiveness data related to the proposed intervention, including cost estimates for~     this type of DM intervention, and to establish a systematic, long-term dissemination plan,~     including documenting effective methodologies, to facilitate faster translation of research~     findings and products to direct consumers in non-research settings.~   "
175744|NCT01264783|"~     The objective of this study is to evaluate the safety and tolerability of RNS60 administered~     intravenously to healthy subjects. 12 subjects will receive RNS60 or placebo at three~     escalating rates for 48 hours for each rate.~   "
175745|NCT01264770|"~     The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid~     arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are~     Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an~     inadequate response to DMARDs. The study will last for approximately six months~   "
175746|NCT01264757|"~     This feasibility study specifically addresses the issue of adapting US dietary guidelines~     physical activity recommendations to the population of the Lower Mississippi Delta. The~     hypothesis is that including a pedometer as a self-monitoring tool as part of adapted~     physical activity guidelines will result in greater immediate increases in physical activity~     (as monitored by an accelerometer) than an education program alone.~   "
175747|NCT01264744|"~     The purpose of the study is the identification of chromosomal aberrations in urine samples.~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classification of UroVysion FISH stained Urine samples.~   "
175748|NCT01264731|"~     The purpose of the study is to determine 1) the safety of administration of topical 5%~     imiquimod cream with or without administration of a peptide-based vaccine in patients with~     cutaneous metastases of melanoma and 2) evaluate whether topical imiquimod at sites of~     melanoma metastasis, with or without vaccine, increases a) endothelial expression of~     E-selectin and b) T cell infiltration.~   "
175749|NCT01264718|"~     9.6 million US Children (13%) have no health insurance, Latino and African-American children~     account for 57% of uninsured children, although comprising only 37% of all US Children.~     Studies show that being uninsured has a negative impact on children's health, healthcare, and~     mortality, however, insuring children results in improved health and healthcare. About 70% of~     uninsured US children (6 million) are eligible for but not enrolled in Medicaid or the~     Children's Health Insurance Program (CHIP), innovative strategies are needed to insure more~     children and eliminate disparities. This is the first randomized controlled trial comparing~     the effectiveness of parent mentors (PMs) to traditional Medicaid/CHIP outreach and~     enrollment in insuring uninsured minority children. The primary study aims are to evaluate~     whether PMs are more effective and more cost-effective than traditional Medicaid/CHIP~     outreach and enrollment in uninsured children. The secondary aim is to determine whether~     children who obtain health insurance experience improvements in healthcare access, health~     status, use of services, and other health outcomes.~      Subjects will be 300 Dallas County uninsured and Medicaid/CHIP eligible Latino and~     African-American children (90% of insured children) and their parent/guardian. Subjects will~     be randomized to PMs or a control group receiving traditional Medicaid/CHIP outreach. PMs are~     experienced parents who have a child currently covered by Medicaid/CHIP. PMs will undergo~     intensive training, and will be paired with intervention subjects and their families, for~     whom they will provide information on Medicaid/CHIP eligibility, help complete/submit~     insurance applications, act as a liaison, and assist in maintaining coverage. Primary~     outcomes will include obtaining health insurance, coverage continuity, time interval to~     obtain coverage, parental satisfaction with the process of obtaining insurance and costs;~     secondary outcomes will include access to care, health status, use of services, quality of~     life, Parental satisfaction, financial burden, and missed school/parental work days. Subjects~     will be contacted monthly for 1 year to monitor outcomes by a blinded assessor. Achievement~     of study aims has the potential to contribute to reducing racial/ethnic disparities, and~     advancing knowledge and practice of child health policy. This intervention could serve as a~     national model for insuring uninsured children and reducing racial/ethnic disparities in~     insurance coverage.~   "
175750|NCT01264705|"~     This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of~     bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This~     study will be activated at the UT Southwestern Medical Center, comprised of The Harold C.~     Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial~     Hospital System. Advanced HCC is defined as disease that is not amenable to surgical~     resection or orthotopic liver transplantation or is metastatic in nature.~   "
175751|NCT01264692|"~     The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral~     administration of ACT 280778 on DBP compared to placebo after 28 days.~   "
175752|NCT01264679|"~     Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375)~     and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic~     treatment of iron deficiency anemia (IDA) with ferumoxytol.~   "
175753|NCT01264666|"~     Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor~     liquor may be beneficial to CVD risk factors postprandially.~      Design: three-way crossover design with one week wash time.16 young men were included to~     consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45%~     alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours~     postprandially.~      Tested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function parameters.~   "
175754|NCT01264653|"~     The purpose of this study is to study the safety and efficacy of intracameral adrenaline for~     pupil dilation without topical mydriatics in refractive cataract surgery.~   "
175755|NCT01264640|"~     The impact of anti-platelet drugs on the concentrations of Brain-derived neurotrophic factor~     (BDNF) in human plasma and serum is unknown. It is the aim of this study to investigate the~     impact of a single dose of Aspirin (500 mg) or Clopdigrel (600 mg) on the concentrations of~     Brain-derived neurotrophic factor (BDNF) in plasma and serum of healthy volunteers.~   "
175813|NCT01263886|"~     Primary Objective:~        -  To demonstrate progression free survival (PFS) improvement for ombrabulin compared to~          placebo, in combination with taxane and platinum, as first line treatment for patients~          with metastatic non-small cell lung cancer (NSCLC).~      Secondary Objective:~        -  To determine overall survival (OS), overall response rate (ORR) according to Response~          Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential~          biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite,~          RPR258063, using a population approach.~   "
175756|NCT01264627|"~     A recent National Health Interview Survey reported that breathing exercises were the second~     most common complementary and alternative medicine practice in the United States, following~     only the use of natural products. With such widespread interest in breathing exercises,~     alone or as a component of practices such as meditation, a need exists for research that~     examines not only its efficacy, but also investigates potential mechanisms of action. Indeed,~     a recent National Center for Complementary and Alternative Medicine (NCCAM) Meditation~     Workshop recommended research to clarify biological pathways by which meditation practices,~     including breathing exercises, can impact health. To explore mechanisms underlying the health~     effects of breathing exercises, new translational tools are needed that can measure breathing~     patterns in both the clinic and natural environment. The primary objective of the present~     proposal is the application of a new technology to the investigation of pathways by which~     breathing exercises can affect health. For this project, the health-related outcome measure~     to be studied is a major cardiovascular risk factor, blood pressure.~   "
175757|NCT01264614|"~     This study will evaluate the effects of low-intensity strengthening exercise on the brain~     (thinking and processing speed) for patients with early dementia, compared with normative~     older adults. Participants will engage in 3 months of exercise 3-5 times per week using a~     chair and small weights. It is hypothesized that there will be a significant improvement in~     brain function.~   "
175758|NCT01264601|"~     Historically, providing influenza vaccination of egg allergic children and young adults (EAC)~     with a history of anaphylaxis to egg, or other severe symptoms of an allergic reaction to egg~     (e.g., severe hives, swelling, or asthma), has been contra-indicated, though vaccination of~     children with less severe egg allergy has been shown to be safe. Though many children with~     severe egg allergy, including anaphylaxis, have received past influenza vaccination~     anecdotally, very few data exist to show this procedure is safe. The investigators propose a~     double blind, placebo-controlled randomized, prospective multi-centered study to a)~     demonstrate seasonal trivalent influenza vaccine (TIV) can be safely given in a single dose~     (as opposed to through 2-step graded dosing of 10% then 90% of the vaccine dose) to EAC~     despite history of anaphylaxis or previous severe allergic reaction to egg; and b) provide~     further evidence that adverse outcomes are not related to ovalbumin (egg) content in TIV.~      Study participants must have a documented history of a severe egg allergy, substantiated by~     both a history of clinical reactivity AND either a positive skin test or ImmunoCAP/RAST test~     greater than 0.7 kUA/L. Participants will be randomized to receive either a 2-step graded~     challenge or a single dose given after a small placebo dose of saline (to mimic the graded~     challenge). If required, all participants will receive a booster vaccination as a single~     dose.~   "
175759|NCT01264588|"~     The purpose of this study is to determine whether topical application of calcium~     glycerophosphate will result in superior wound appearance and scar minimization.~   "
175760|NCT01264575|"~     This prospective randomized double-blind dose-response study is aimed to investigate the ED50~     and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee~     replacement arthroplasty.~   "
175761|NCT01264562|"~     The study will investigate the impact of cancer-related stress and its consequences (acute~     and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in~     breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and~     the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients~     shall be evaluated.~   "
175762|NCT01264549|"~     Development of stroke associated pneumonia (SAP) has a detrimental effect on stroke outcome.~     Biomarker-guided antibiotic treatment of patients at high risk for pneumonia may help to~     improve stroke outcome. Therefore, the investigators will evaluate whether intensified~     infection monitoring via Procalcitonin guiding an early standardized antibiotic treatment~     improves functional outcome after stroke compared with standard therapy based on current~     guidelines.~   "
175763|NCT01264536|"~     We will test the hypothesis that bovine lactoferrin supplementation prevents serious~     infections in preterm infants. We will conduct a randomized placebo-controlled double blind~     study in 190 premature infants <2500 gm in 5 Neonatal Intermediate and Intensive Care Units~     in Lima, Peru to determine whether bovine lactoferrin prevents the first episode of~     late-onset sepsis.~   "
175764|NCT01264523|"~     The main objective of this study is to evaluate the effects on anthropometric, glucose~     metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index~     products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2~     diabetes patients following a chronologically scheduled pattern.~   "
175765|NCT01264510|"~     A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and~     a sound processor connected with the implant. The sound processor delivers bone conducted~     stimuli to the cochlea, bypassing the outer and middle ear.~      Some patients who are unable to wear or do not benefit from a conventional air-conduction~     hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or~     a mixed hearing loss. Recently however, Baha's are also being recommended in patients with~     unilateral deafness. Sound coming from the deaf side is captured and transmitted through bone~     conduction to the normal inner ear. The overall benefit of a Baha is more difficult to assess~     in those patients.~      Therefore, the goal of the current study is to examine the benefit of a Baha in patients with~     different audiological profiles (unilateral or bilateral conductive or mixed hearing loss,~     and unilateral deafness). Special attention will be given to predictive determinants of the~     benefit with a Baha, and to the improvement of pre-operative criteria and counseling of~     patients.~   "
175766|NCT01264497|"~     The purpose of this study was to determine whether TH9507, a stabilized analogue of growth~     hormone-releasing factor (GRF), would have an effect on insulin sensitivity or control of~     diabetes in patients with type 2 diabetes.~   "
175767|NCT01264484|"~     The objective of this study is to assess long term safety and durability of the Advantage~     prosthetic heart valve.~   "
175820|NCT01263782|"~     The goal of this clinical research study is to learn if knowing biomarker status can help~     researchers find better treatment combinations for patients with advanced NSCLC.~      Researchers want to use biomarker status to decide what drug (bevacizumab, or cixutumumab) to~     give in combination with carboplatin and pemetrexed. The safety of these drug combinations~     will also be studied.~   "
175768|NCT01264471|"~     The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War~     Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou~     Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias~     (muscle pain), as well as other neurological symptoms. Abnormalities in the part of the cell~     known as mitochondria have been delineated in Gulf War Syndrome. Mitochondria are the power~     plants of the body. Mitochondria take the food you eat and break the food down into a form~     of energy that the body can use. The investigators propose that Gulf War Syndrome is~     determined by a complex interaction of factors that interfere with mitochondrial function.~     This study will be the first investigation of mitochondrial function in Gulf War Syndrome.~     The investigators objective is to establish the cause for symptoms in affected veterans,~     develop testing that can more easily identify Gulf War Syndrome, and ultimately develop~     treatment protocols for Gulf War Syndrome.~   "
175769|NCT01264458|"~     The purpose of this research study is to look at how trauma affects the ability of blood to~     clot. The blood of people who suffer a traumatic injury can under-clot or over-clot, and this~     research study will look at blood drawn from people after they suffer a traumatic injury to~     see how well their blood clots.~   "
175770|NCT01264445|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an~     adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1,~     2, 3, and 4.~   "
175771|NCT01264432|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with radiation therapy in treating patients with advanced solid malignancies (abnormal cells~     divide without control and can invade nearby tissues) with peritoneal carcinomatosis,~     epithelial ovarian, fallopian, or primary peritoneal cancer. Veliparib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses~     high energy x rays to kill tumor cells. Giving veliparib with radiation therapy may kill more~     tumor cells.~   "
175772|NCT01264419|"~     The purpose of this study is to demonstrate the safety and feasibility of the Silk Road~     Medical Embolic Protection System for use in subjects who are candidates for Carotid Artery~     Stenting (CAS). Safety is a composite of any major stroke, myocardial infarction and death~     during the 30-day post procedural period.~   "
175773|NCT01264406|"~     This study will compare the effect of two doses of exercise on energy intake and body weight.~     The comparison will be between three groups; two exercise groups and a control group. The~     exercise groups will not be provided with a dietary intervention and the study design also~     includes a non-exercise control group. E-Mechanic trial can make important contributions to~     understanding of the role of exercise dose in weight management. While it is accepted that~     regular exercise plays an important role in general health, the exact role of exercise in~     prevention of weight gain, weight loss and prevention of weight regain remains poorly~     understood despite exercise being widely prescribed for these purposes. The idea that current~     weight management exercise recommendations may produce increased energy intake (or other~     forms on compensation) resulting in disappointing weight loss is an important public health~     issue. The finding of this study could help shape future exercise and weight loss~     recommendations and treatment plans.~   "
175774|NCT01264393|"~     Behavioral weight loss programs can successfully reduce body weight, but these programs are~     available to limited numbers of overweight and obese individuals. This project evaluates a~     unique weight loss approach that combines a self-sustaining weight loss campaign (for~     outreach) with training in behavioral weight loss strategies and strategies to increase~     accountability (to improve weight loss success). This innovative combination has the~     potential to be a cost-effective model for disseminating weight control interventions.~   "
175775|NCT01264380|"~     This randomized, open-label, two period crossover study will evaluate the effect of food on~     the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous~     administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients~     will be randomized to receive in a crossover design single oral doses of RO5185426 with or~     without food, with a 10-day washout period between doses. Following the crossover periods,~     patients will receive RO5185426 orally twice daily on a continuous basis until disease~     progression or unacceptable toxicity occurs.~   "
175776|NCT01264367|"~     A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence~     compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine~     and peg-interferon sequential treatment in patients with chronic Hepatitis B who have~     HBeAg(+)~   "
175777|NCT01264354|"~     This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir~     and clevudine combination in patients with chronic hepatitis B.~   "
175778|NCT01264341|"~     The purpose of this study is to determine whether the combination of bevacizumab/temsirolimus~     is effective in patients with advanced renal carcinoma progressing after anti-VEGF treatment~   "
175779|NCT01264328|"~     The clinical hypothesis of this study is that the first-line treatment with the combination~     of panitumumab and paclitaxel will provide benefit for patients with metastatic or current~     Squamous Cell Carcinoma of the Head and Neck (SCCHN)~   "
175780|NCT01264315|"~     Rationale: We recently reported a study where overall and event free survivals in newly~     diagnosed myeloma patients receiving an autologous transplant followed by an allograft from~     an HLA-identical sibling were superior as compared to those undergoing a double autologous~     transplant. A larger multicenter study by the Gruppo Italiano Trapianti di Midollo (GITMO),~     co-ordinated by our group and recently closed, employing a tandem auto-allo approach in newly~     diagnosed patients confirmed the achievement of prolonged event free and overall survival.~     Importantly, the achievement of at least very good partial remission at the time of~     allografting conferred a significant advantage in both event-free-survival (HR 0,23, CI~     0,11-0,48; p=0,0001) and overall survival (HR 0,26; CI 0,09-0,79; p=0,02). Moreover, recent~     advances in the understanding of the pathogenesis of multiple myeloma have identified~     specific signalling pathways that have become targets for biologically-based drugs such as~     thalidomide, bortezomib and lenalidomide and employed in several trials, including after~     allograft. The aim of the current proposal is to combine the post-transplant efficacy of~     graft-vs.-myeloma with the anti-myeloma effect of lenalidomide in newly diagnosed myeloma~     patients with an HLA-identical sibling treated with a tandem autograft-allograft approach.~     Maintenance/consolidation of the response may be a key factor to further improve rate of~     clinical and molecular (as a prelude to cure) remissions and prolong overall and event free~     survivals after allografting. We would like to investigate the safety and efficacy of~     lenalidomide as consolidation/maintenance therapy in patient undergoing tandem~     autologous-allogeneic transplant.~      Objectives of study: To evaluate 1) toxicity and tolerability of lenalidomide after~     allografting; 2)To evaluate efficacy of lenalidomide in inducing complete remission, defined~     as negative immunofixation, 12 months after allografting; 3) overall-survival; 4) event-free~     survival; 5) molecular remission rate. Furthermore we plan to compare molecular remission~     rate in patients treated with lenalidomide after tandem auto-allo transplant and after double~     autologous transplant and to monitor minimal residual disease in patients achieving clinical~     CR with lenalidomide.~      Patient Selection: Patients with newly diagnosed multiple myeloma with an HLA identical~     sibling suitable for PBSC donation will be included. Complete cytogenetic analysis at~     diagnosis will be required. The patient must have the capacity to give informed consent. Age~     >18 and < 65. Negative pregnancy test and willing to use contraceptive techniques during and~     for 12 months following treatment is required. Only very unfitted patients will be excluded.~      Treatment plan: Lenalidomide will be started at 6 months post-allotransplant at the dose of~     10 mg/day continuously in all patients (unless in molecular CR), if the following conditions~     are present:~        -  absolute neutrophil count > 1 x 109/L without the use of growth factors;~        -  platelet count > 75 x 109/L without transfusion support;~        -  calculated or measured creatinine clearance: ≥ 20 mL/minute;~        -  total bilirubin < 2 x the upper limit of normal,~        -  AST and ALT < 2.5 x upper limit of normal~        -  less than 1 mg/kg/day of prednisone, and no more than 2 immunosuppressive drugs other~          than steroid to control GVHD (if more immunosuppression is required to control GVHD, the~          maintenance therapy with lenalidomide will be held until this criteria will be~          satisfied) Treatment will be continued without interruption, unless not tolerated, until~          unacceptable adverse events are experienced or progressive disease occurs. Moreover,~          lenalidomide will be discontinued in patients who achieve and maintain molecular~          remission for 2 consecutive controls at least 6 weeks apart.~      Safety section - dose modification plan: During the study patients will be monitored for the~     occurrence of side effects. Toxicity events will be graded according to the NCI toxicity~     criteria. In case of severe toxicity, the lenalidomide dose will be reduced or withheld as~     outlined in the protocols.~      Statistical section: - Total patient sample size: 53. This is a phase 2 study designed~     according to a Simon's two-stage Minimax Design. An early stopping rule will be established~     to interrupt the study in case of futility (a non satisfactory response rate). In stage I 27~     patients will be enrolled; if < 14 complete remissions will be observed, the trial will be~     stopped. In stage II 26 more patients will be enrolled. If ≥ 32 responses will be observed,~     it will be concluded that the lenalidomide maintenance is active in increasing the complete~     remission rate after auto-allograft.~      Analysis plan: Toxicity monitoring will be incorporated into the study design by requiring~     that the trial be terminated after an initial stage if the number of observed toxicities~     (treatment related deaths) is excessive.~   "
175781|NCT01264302|"~     The objective of this study was to evaluate the relative bioavailability of the test~     formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference~     formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fed conditions in healthy adult~     male subjects.~   "
175782|NCT01264289|"~     The objective of this study was to evaluate the relative bioavailability of the test~     formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference~     formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fasting conditions in healthy adult~     male subjects.~   "
175821|NCT01263769|"~     The goal of this clinical research study is to learn if axitinib can help to control kidney~     cancer. The safety of this drug will also be studied.~   "
175905|NCT01262677|"~     Approximately 30% percent of subjects with partial seizures are refractory to treatment with~     single or combination antiepileptic drugs. The present study will compare the efficacy of two~     different dosages of pregabalin CR dosed once daily as compared to placebo, when used as~     adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using~     a randomized, parallel group design.~   "
175783|NCT01264276|"~     The primary objective of this multi-center clinical study is to evaluate the validity,~     reliability, feasibility, safety and relative cost-effectiveness of a retinopathy of~     prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies who meet~     referral warranted ROP (RW-ROP) criteria and therefore need a diagnostic evaluation by an~     ophthalmologist experienced in ROP.~      We shall:~        1. Calculate the accuracy, using sensitivity and specificity, of the system to provide~          remote evaluations when compared with the findings of a gold standard indirect~          ophthalmoscopic examination performed by a Study-certified ophthalmologist, rigorously~          trained in ROP diagnostic examinations (validity);~        2. Determine intra-reader and inter-reader agreement for deciding whether digital images~          indicate that the eyes of a baby are in need of diagnostic indirect ophthalmoscopy by an~          ophthalmologist experienced in ROP (reliability);~        3. Determine whether imaging evaluation can be achieved for each baby (feasibility);~        4. Examine ocular and systemic complications associated with digital imaging and compared~          with those associated with diagnostic examinations performed by an ophthalmologist~          (safety);~        5. Compare the costs and benefits of adopting a telemedicine retinal imaging system~          compared to the current cost of indirect ophthalmoscopic examinations~          (cost-effectiveness).~   "
175784|NCT01264263|"~     This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and~     several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic~     patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.~   "
175785|NCT01264250|"~     In this early phase study, healthy male volunteers will be randomly assigned to one dose of~     either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and~     Pharmacokinetics of AZD2927.~   "
175786|NCT01264237|"~     The present study will aim to determine the safety, efficacy, and tolerability of etoricoxib,~     an NSAID pain reliever, in patients with Neuropathic pain. Neuropathic pain, or pain caused~     by abnormal activity of sensory neurons, remains undertreated. Post herpetic neuralgia (PHN),~     which is commonly referred to as post-shingles pain, is the most useful disease to study when~     investigating the efficacy of pain relievers for Neuropathic pain. Therefore, this study will~     primarily involve patients with PHN.~      The hypothesis in this study is that etoricoxib efficacy is superior to that of placebo.~   "
175787|NCT01264224|"~     1. Primary Objective:~             -  To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028~               in healthy male volunteers.~        2. Secondary Objective:~             -  To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral~               dosing of PAC-14028 in healthy male volunteers.~   "
175788|NCT01264211|"~     To evaluate the efficacy of Diacerein 100 mg daily versus placebo in reducing rheumatoid~     arthritis symptoms, when added to stable oral MTX therapy in patients with active early RA.~      To evaluate the safety of Diacerein 100 mg daily when administrated in combination with oral~     MTX therapy in those patients for up to 24 weeks~      To investigate a potential persistent effect, 4 weeks after Diacerein treatment is stopped~     (carry-over effect)~   "
175789|NCT01264198|"~     The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in~     patients with NAFLD.~   "
175790|NCT01264185|"~     The purpose of this study is to conduct preparatory research needed to design a behavioral~     intervention to decrease sexual transmission risk behaviors in HIV-infected individuals in~     care and to determine whether a similar intervention structure can be used across various~     sexual risk groups and cultural settings.~   "
175791|NCT01264172|"~     This project investigate any difference in inflammatory response,wound heeling rate,~     functional outcome and level of pain in patience with different surgical treatment (PCCT vs.~     DHS vs. Osteosynthesis with nails) after a fracture of the proximal femur.~   "
175792|NCT01264159|"~     It is well known that 20-25% of patients hospitalized for acute myocardial infarction will~     develop acute heart failure during their hospitalization. Currently, the investigators have~     no reliable parameter for prediction of evolving acute heart failure in such a group of~     patients. As a result, the investigators have no way of preventing acute heart failure.~     Treatment of these patients only begins after appearance of clinical signs of acute heart~     failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of~     evolving acute heart failure. This study will attempt to address whether preemptive lung~     impedence-guided therapy may prevent the development of overt acute heart failure and improve~     their clinical outcome.~   "
175793|NCT01264146|"~     This study aims to test the hypothesis that postoperative daily hyperbaric oxygen therapy~     (HBOT) decreases soft-tissue complication rate during the operative handling of~     intra-articular calcaneal fractures. Minor motivations: 1. To evaluate microcirculatory~     criteria of cutaneous tissue predicting emerging wound healing defects, 2. To identify~     patients at risk for soft-tissue complication after calcaneal plate osteosynthesis and to~     determine the optimal time point for operative intervention using these microcirculatory~     criteria preoperatively, 3. To evaluate the effect of HBOT on postoperative microcirculation,~     4. To collect preliminary data to evaluate the economical impact of wound complications, with~     and without HBOT, 5. To identify a correlation between HBOT with expected limited soft-tissue~     complication rate and the clinical and radiographic outcome two years after surgery.~   "
175794|NCT01264133|"~     An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy~     or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with~     chronic hepatitis B.~   "
175814|NCT01263873|"~     The purpose of the study is to determine if there are differences related to ease of~     intubation reported by clinicians who use the Parker Flex-Tip® endotracheal~     tubes(ETT)compared to the standard Mallinckrodt® (ETT). The problem is two (ETTs), the Parker~     Flex-Tip® and the Mallinckrodt®, are currently available for use in operative suites for~     intubation, but few studies have compared these devices with each other. Two research~     questions to be answered in the study are 1. Is there a difference in the ease of intubation~     when the Parker Flex-Tip® (ETT) is used when compared to the standard Mallinckrodt® (ETT)?~     and 2. Are there differences in the number of successful intubations when comparing the~     Parker Flex-Tip® (ETT) and the standard Mallinckrodt® (ETT)? The hypotheses are the use of~     the Parker Flex-Tip® (ETT) will demonstrate: 1. Fewer seconds to intubate the trachea. 2.~     Higher self-reported ease of placement scores and 3. Fewer redirections to intubate the~     trachea. The number of successful intubations is expected to be the same in both arms of the~     study.~   "
175795|NCT01264120|"~     Obesity is a major health problem that is affecting more and more people's lives. One of the~     most successful treatments for obesity is weight loss surgery. Not all patients, however,~     lose the desired amount of weight, some regain weight and some have the surgery reversed.~     Interviews with patients and discussions with patient support groups indicate that many of~     the 'unsuccessful' patients feel unprepared for the operation and describe how although the~     surgery fixes their body it neglects their mind. They would therefore like to have more~     psychological support.~      The present study aims to set up and evaluate a health psychology led bariatric~     rehabilitation service (BRS) and determine the impact of such a service on patient outcomes~     following surgery. The BRS would offer information, support and mentoring pre and post~     surgery and address psychological issues such as dietary control, self esteem, coping and~     emotional eating. It is predicted that a bariatric rehabilitation service would primarily~     improve weight loss following surgery but would also aid changes in other aspects of the~     patient's well being.~      Obesity is a risk factor for a multitude of illnesses such as heart disease, diabetes and~     cancer. If effective, obesity surgery improves a patient's health and reduces their need for~     NHS care. If unsuccessful then the costs include not only subsequent NHS costs due to these~     other illnesses but also the costs of the unsuccessful operation and the emotional cost to~     the patient. The bariatric rehabilitation service should help to improve the effectiveness of~     surgery which in the longer term is likely to be cost effective.~      This research is a direct response to the needs identified by patients and by offering a more~     comprehensive bariatric service the success and subsequent health and well being of obese~     patients should be improved.~   "
175796|NCT01264107|"~     An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With~     Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.~   "
175797|NCT01264094|"~     The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic~     Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.~   "
175798|NCT01264081|"~     Background:~      - Studies of melanoma tumor samples have shown that tumor cells from approximately 20 percent~     of melanoma patients contain a specific mutation of a gene involved in making a protein~     called ERBB4, and that changes in this gene have been associated with cancer. Lapatinib, a~     drug that is currently approved for the treatment of breast cancer, has been shown in the~     laboratory to significantly slow the growth of melanoma cells that contain this specific~     ERBB4 gene mutation. Researchers are interested in determining whether lapatinib can be~     effective against melanoma in individuals who have the ERBB4 mutation.~      Objectives:~      - To evaluate the safety and effectiveness of lapatinib as a treatment for melanoma with~     ERBB4 mutation that has not responded to standard therapy.~      Eligibility:~      - Individuals at least 18 years of age who have stage 4 melanoma that has not responded to~     standard therapy.~      Design:~        -  Participants will be screened with a full physical examination and medical history, as~          well as tests of tumor tissue taken from previous surgeries or biopsies or from a new~          biopsy that will be conducted before the start of the study. Test results to determine~          eligibility will be available within about 2 weeks.~        -  Participants will take four lapatinib tablets daily (two in the morning, 1 hour before~          or after breakfast and two in the evening, 1 hour before or after dinner) during every~          28-day cycle of treatment. Participants will keep a medication diary to record tablets~          taken and any side effects from the medication.~        -  After the first 2 weeks, and every 2 to 4 weeks afterward for the first 12 weeks,~          participants will have clinic visits with blood samples and other tests to determine if~          lapatinib is causing their disease to shrink or be controlled. If the disease has not~          progressed, participants will continue to receive a new lapatinib supply every 28 days~          for up to 2 years (27 cycles), and will continue to have regular clinic visits to~          monitor the progress of treatment.~        -  When tumor tissue is easily accessible and can be easily biopsied, researchers will~          collect two additional biopsies, one after 2 weeks of treatment and one after 12 weeks~          of treatment....~   "
175799|NCT01264068|"~     Traditional Chinese herbal medicine, no matter mono-therapy or poly-pharmacy, is composed of~     complicated chemical constituents. Many confounding factors influence activity of Chinese~     herbs, including the origin of the herbs, safety of the products and consistency between~     batches. Study of the effectiveness and mechanism of Chinese herbs in vivo is much more~     challengeable due to unresolved problems of product quality control, screen of effective~     principles, monitor of the marker constituents and the targets for site of action. In this~     project, we will introduce the concept of metabolomics to detect total metabolites spectra as~     the biomarkers of Chinese herbs intervention. Correlation will be analyzed between changes in~     total metabolites and clinical improvements when menopausal women receive Suan Tsao Jen Tang~     or Jia Wey Shiau Yau San, and postpartum women receive生化湯.~   "
175800|NCT01264055|"~     Background:~      - Bronchiectasis is a type of lung condition in which the lungs airways are abnormally~     stretched and widened. This stretching and widening makes it difficult for mucus and other~     substances to move out of the lungs, encouraging the growth of bacteria and leading to~     breathing problems or infection. Bronchiectasis can be caused by genetic disorders or~     diseases such as tuberculosis or rheumatoid arthritis. Researchers are interested in~     developing better ways to diagnose and treat a lung problem called idiopathic or unexplained~     bronchiectasis.~      Objectives:~      - To better describe the physical characteristics, radiographic patterns, and airway~     microbiology of unexplained bronchiectasis and to look for possible genetic links or risk~     factors.~      Eligibility:~        -  Individuals at least 18 years of age who have a chronic cough and who have had a CT scan~          that has revealed signs of bronchiectasis.~        -  Current smokers or those who have smoked for at least 10 years, as well as individuals~          who have known causes of bronchiectasis or who have had organ transplants, are not~          eligible to participate.~      Design:~        -  Participants will have one outpatient clinic visit for evaluation with a physical~          examination including detailed body size measurements and medical history and for~          collection of blood samples for routine lab tests and genetic analyses and a chest x-ray~          if no recent one is available.~        -  Participants will also have tests of lung function, and measurement of a gas called~          nitric oxide in the nose. Participants whose initial tests show abnormal results may~          also be asked to have a nasal scrape to collect cell samples and/or a skin sweat test to~          measure salt concentrations.~        -  Participants will also have a sputum specimen collected during the visit and will be~          asked to collect two additional early morning sputum samples and a mouth rinse at home~          within 2 weeks of the clinic visit, and mail the sample collection materials to the~          research team.~   "
175801|NCT01264042|"~     Although the essential role of iron during pregnancy is well established, concerns have been~     raised that current iron supplements given routinely during pregnancy may also have harmful~     consequences, such as increased oxidative stress and enhanced risks of infection,~     pre-eclampsia and impaired glucose regulation. A potential mechanism for the production of~     adverse effects is the appearance of non-transferrin-bound iron after oral administration of~     iron supplements. Non-transferrin-bound iron is more readily available to pathogens and could~     promote injurious free radical reactions that might add to the oxidative stress of pregnancy.~      The present study will determine if oral administration of 60 mg of iron as ferrous sulfate~     during the second trimester of pregnancy is followed by the appearance of~     non-transferrin-bound iron two hours later. The investigators will examine the influence of a~     variety of factors, including iron status and previous use of iron supplements. Detection of~     non-transferrin-bound iron after administration of an iron supplement to pregnant women would~     be an important new observation that could lead to re-evaluation of current methods of iron~     supplementation.~   "
175815|NCT01263860|"~     Patients with HCV genotype 6 infection who have a rapid virological response to treatment are~     randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no~     important difference in effect between the two treatment effect.~   "
175816|NCT01263847|"~     The purpose of this study is to determine the effects of galactooligosaccharide (GOS)~     supplementation on calcium absorption and and gut microbe profiles.~   "
175817|NCT01263834|"~     The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on~     the result of trabeculectomy in primary term of intraocular pressure (IOP).~   "
176405|NCT01256151|"~     To assess if the sublingual tablet will have similar pharmacokinetics as the conventional~     tablet of alprazolam.~   "
175802|NCT01264029|"~     Background:~        -  New weight-loss intervention programs are being studied to determine their effectiveness~          in helping overweight and obese individuals reach a healthy weight. However, these~          programs often have not been tested against each other, and researchers are interested~          in determining which interventions are most effective both immediately and over the long~          term in promoting and maintaining weight loss.~        -  Mindful Tai Chi is a combined form of the meditative martial art tai chi and the~          practice of mindfulness meditation. Tai chi and mindfulness meditation both have common~          philosophical underpinnings that address health promotion and well-being by applying the~          skill of non-judgmental awareness on a moment-to-moment daily basis. More research is~          needed on whether Mindful Tai Chi and mindfulness meditation can help improve various~          health factors in overweight and obese individuals.~      Objectives:~      - To compare the effects of Mindful Tai Chi, mindfulness meditation, walking, or a discussion~     group on the weight and well being of overweight and obese participants.~      Eligibility:~      - Healthy individuals at least 18 years of age who are either overweight or obese (body mass~     index between 25 and 40), have a sedentary lifestyle (have not engaged in more than 1 hour of~     aerobic exercise per week within the last month), and are willing to commit to a specific~     weight-loss intervention program.~      Design:~        -  This study involves four visits for collecting information and 12 weeks of research~          study activities.~        -  During the first visit, participants will hear information about the study and may ask~          any questions. They will be screened with a medical history and physical examination,~          and those eligible will be assigned to one of the four study groups: Mindful Tai Chi~          (MTC), Mindfulness Meditation (MM), Mall Walking (MW), or Weekly Discussion (WD) group.~        -  For the second visit, participants will give blood and urine samples, receive an~          abdominal ultrasound, ride a stationary bicycle for 5 minutes, and fill out~          health-related questionnaires.~        -  For 12 weeks, participants will be involved in the following activities depending on~          their group:~        -  MTC: Class for 2 hours per week, emphasizing the meditation aspects of tai chi. Each~          session will include at least 20 minutes of meditation. Participants will receive~          written instructions and an accompanying DVD in comparable formats specifying a minimum~          of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a~          workshop for mindfulness skill application in daily activity.~        -  MM: Class for 2 hours per week of mindfulness meditation. Participants will receive~          written instructions and an accompanying DVD in comparable formats specifying a minimum~          of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a~          workshop for mindfulness skill application in daily activity.~        -  MW: Participants will meet at a designated mall location once a week for 2-hour walk.~        -  WD: Participants will meet at the National Institutes of Health for weekly weight-loss~          discussion.~        -  For the third and fourth visits, participants will receive the same procedures as those~          used in the second visit. These visits will occur at the end of the 12-week activity~          period and at a 3-month follow up visit.~   "
175803|NCT01264016|"~     The purpose of this study is to evaluate the performance and acceptability of a new blood~     glucose monitoring system, which includes meter and sensor strip.~   "
175804|NCT01264003|"~     Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when~     prosthetic materials are used. This prospective randomized study has been set to observe if~     antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.~   "
175805|NCT01263990|"~     Main hypothesis: there is no difference between stroke volume measurements recorded by a new~     noninvasive finger cuff system (NexFin) and invasive hemodynamic monitoring systems as~     Picco2-system, FloTrac and transesophageal echocardiography~   "
175806|NCT01263977|"~     Septic shock and multi-organ failure are among the most frequent causes of death in the ICU.~      Patients with septic shock require early implementation of hemodynamic therapy to keep the~     duration of shock state and with it microcirculatory disturbances as short as possible. In~     the septic shock guidelines by the american association SCCM the diagnosis of volume status~     is based on filling pressures, like CVP. Some studies show, that the CVP depends not only on~     the intravascular volume, but also on the right ventricular compliance, pulmonary vascular~     resistance as well as intrathoracic pressure. The aim of the Study is to evaluate if the~     duration of septic shock can be reduced through algorithm driven volume therapy orientated to~     thermodilution based volume parameters (GEDI and ELWI)~   "
175807|NCT01263964|"~     The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in~     Acute ischemic Stroke) is to elucidate the underlying pathomechanism of cTnT elevation in~     acute ischemic stroke. Consecutive patients with acute ischemic stroke admitted to the~     Department of Neurology Campus Benjamin Franklin of the university hospital Charité will be~     screened for cTnT elevations suggestive of myocardial infarction (>0,05 µg/l). Patients with~     increased troponin will undergo diagnostic coronary angiography within 72 hours. Diagnostic~     findings of coronary angiographies taken out in age- and gender-matched patients presenting~     with NSTE-ACS (Non-ST-Elevation Acute Coronary Syndrome) to the Division of Cardiology will~     serve as a control. The primary endpoint of the study will be the occurrence of culprit~     lesions indicating focal cardiac damage on the basis of an acute CAD.~   "
175808|NCT01263951|"~     The goal of this study is to determine the effect of combining everolimus and sorafenib in~     patients with metastatic differentiated thyroid cancer who progressed on sorafenib alone.~   "
175809|NCT01263938|"~     Activated monocytes play a key role in the pathogenesis of HIV-associated neurocognitive~     disorders (HAND). Individuals with HAND have expanded populations of activated monocytes.~     These monocytes are thought to emigrate into the CNS, where they produce neurotoxic~     proinflammatory factors, and also carry virus into the CNS. Statins are cholesterol lowering~     drugs with pleiotropic immunomodulatory / anti-inflammatory properties that are currently~     being explored for immunomodulation of T cell activation in several diseases, in addition to~     their established role to treat hyperlipidemia and atherosclerosis. The investigators in~     vitro data suggests that these drugs can downregulate monocyte activation patterns seen in~     HIV infection. No in vivo studies have yet been carried out to assess the effects of statins~     on the pro-inflammatory monocyte population in chronic HIV disease. This will be a pilot~     study of whether statin treatment will reduce the inflammatory monocyte phenotype and~     downregulate the inflammatory cytokines that have been linked to neuropathogenesis in HIV~     infection. If so, they may have potential as adjunctive therapy in HIV-associated~     neurological disease. The investigators propose to:~        -  Determine the effect of Atorvastatin on peripheral blood monocyte populations in a~          12-week pilot study in chronically HIV-infected people on HAART therapy.~        -  Determine the relationship between changes in monocyte phenotype following Atorvastatin~          treatment, and soluble markers of activation/inflammation linked to neuropathogenesis,~          as well as activation status of T cells.~   "
175810|NCT01263925|"~     Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with~     Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the~     pain-free walking distance in patients with Intermittent Claudication.~   "
175811|NCT01263912|"~     This is a prospective longitudinal study that will involve 200 infants enrolled at 12-13~     months of age. The study will use a classic nutrition design to assess if infants' feeding~     practices in Canada place infants 1-2 years of age at risk for low long chain polyunsaturated~     fatty acid (LCPUFA), nutrients known to influence growth, and brain and immune system~     development. On enrollment, infants will be assigned at random to a nutrition supplement~     providing omega 6 and omega 3 LCPUFA or a PUFA placebo.~   "
175812|NCT01263899|"~     This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with~     advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent~     Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small~     lymphocytic lymphoma).~   "
175822|NCT01263756|"~     The proposed pilot study will begin to assess whether driving impairments are included in the~     functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed~     by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who~     drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6~     hours of assessments) and one driving simulation visit (approximately 2.5 hours). The~     investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have~     been identified as having an ASD from a prior diagnosis or participation in community~     conferences for individuals with ASDs.~   "
175823|NCT01263743|"~     Interventions such as Relaxation Response appear to have widespread effects on physiology.~     Endothelial function, changes in genomic expression, several biomarkers have been associated~     with chronic stress and cardiovascular dysfunction, and there is some suggestion that~     elicitation of the Relaxation Response may lead to improvement in-or normalization of-these~     factors. By studying the impact of the Relaxation Response on endothelial function, genomic~     expression and biomarkers among subjects with hypertension, it may be possible to better~     understand the biologic underpinnings of Relaxation Response-type interventions. Furthermore,~     with a greater understanding of the physiologic mechanisms by which the Relaxation Response~     works, it may be possible to better target other symptoms and conditions that can be~     effectively treated by such an intervention.~   "
175824|NCT01263730|"~     The goal of this research is to evaluate whether Tai Chi merits further investigation as a~     non-pharmacological therapy in the treatment of Major Depressive Disorder (MDD).~     Specifically, this waitlist-controlled study will gather preliminary data evaluating the~     effectiveness of Tai Chi training as treatment for patients with MDD or a history of MDD,~     including patients who continue to be depressed despite taking antidepressants and patients~     who choose not to take antidepressants due to fear of side effects and/or for personal~     reasons. To test this hypothesis the investigators will compare physical and psychological~     parameters of a control group and an intervention group, at baseline (Week 0), at the~     midpoint (Week 6), and at the end of 12 weeks of Tai Chi training.~   "
175825|NCT01263717|"~     HIV-infection and its treatment are often associated with an increase in belly fat, as well~     as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and~     increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may~     contribute independently to increased belly fat and to increased cardiovascular risk through~     effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth~     hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients~     with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat~     accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet~     known. The current study is designed to determine the effects of tesamorelin treatment on fat~     accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers~     of cardiovascular health including blood vessel thickness (carotid intima media thickness~     [cIMT]) and markers of inflammation in the body. The investigators hypothesize that~     tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers~     of inflammation, with either neutral or beneficial effects on glucose metabolism.~   "
175826|NCT01263704|"~     This single arm, open-label study will assess the safety and efficacy of low dose fludarabine~     and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as~     primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic leukemia.~     Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2~     intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5~     mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6).~     Anticipated time on study treatment is 6 months, with a 30-month follow-up period.~   "
175827|NCT01263691|"~     The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and~     immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and~     female subjects between 18 and 50 years of age will receive vaccinations via the~     intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via~     laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant~     medications, and local and systemic signs and symptoms of reactogenicity.~   "
175828|NCT01263678|"~     Treatment options for lumbar spinal stenosis include surgical and non-surgical approaches.~     For most people, the decision depends on how bothered they are by their symptoms and how they~     feel about having surgery. Since individuals with the same clinical presentation may feel~     differently about their symptoms and how they view the benefits and harms of their options,~     there is no agreed upon besttreatment. It has been shown that, for preference-sensitive~     decisions like this one, decision aids (tools that pair balanced, evidence-based information~     regarding treatment options with values clarification) improve patients'knowledge and~     realistic expectations, lower decisional conflict, increase patient involvement in decision~     making, decrease the number of undecided, and increase agreement between values and choice.1~     The Spine Center, in collaboration with the Center for Shared Decision Making (CSDM) at~     Dartmouth Hitchcock Medical Center (DHMC), has been providing patients with decision aids~     (DAs) for several years.~      Hypothesis:~      Patients identified as having low literacy and/or high decisional conflict after viewing a~     video decision aid will show greater resolution of their decisional conflict, higher decision~     self-efficacy and less decision regret if a coaching intervention is paired with a video~     decision aid.~      Decision support in the form of coaching develops patients'skills in preparing for a~     consultation and deliberating about their options.2 A study of women with abnormal uterine~     bleeding showed that pairing coaching with a DA helped patients clarify their values and~     preferences, reduced costs, and increased long term satisfaction.3 The investigators plan to~     assess the impact of coaching in patients with lumbar spinal stenosis who are referred to the~     CSDM for a video decision aid about their treatment options. The investigators are also~     interested to learn whether screening for low literacy and high decisional conflict can~     identify a subgroup of patients who are more likely to benefit from coaching.~   "
175829|NCT01263665|"~     The purpose of this study is to confirm the safety and performance of the 25 cm GORE®~     VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral~     Artery.~   "
175830|NCT01263652|"~     The investigators will conduct a randomized double blind study, to determine whether patient~     analgesic delivery mode preference affects pain reduction quality in non-surgical spine~     patients.~      The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo.~     During the study period, pain reduction parameters will be collected. At the end of the study~     period, the investigators will attempt to find a correlation between pre-study patient~     preferences and the quality of the pain reduction achieved.~   "
175853|NCT01263353|"~     The purpose of this study is to assess the safety and tolerability of pasireotide LAR in~     combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary~     neuroendocrine Tumors (NET).~   "
175831|NCT01263639|"~     Objectives: Patient satisfaction is a key determinant of the quality of care and an important~     component of pay for performance metrics. The purpose of this study was to evaluate the~     impact of a simple intervention aimed to increase patients' understanding of their~     orthopaedic trauma surgeon and improve patient satisfaction with the overall quality of~     inpatient care delivered by the attending surgeon.~      Design: Prospective quality improvement initiative using a randomized intervention.~      Setting: Level 1 academic trauma center.~      Patients/Participants: Two hundred twelve patients were eligible; 100 patients were~     randomized to the intervention group, and 112 patients were randomized to the control group.~     Overall, 76 patients could be reached for follow-up satisfaction survey, including 34~     patients in the intervention group and 42 patients in the control group.~      Intervention: Patients randomized to the intervention group received an attending biosketch~     card, which included a picture of the attending orthopaedic surgeon with a brief synopsis of~     his educational background, specialty, surgical interests, and research interests.~      Main Outcome Measures: Our primary outcome measure was a patient satisfaction survey~     assessing patients' rating of the overall quality of inpatient care delivered by the~     attending surgeon.~   "
175832|NCT01263626|"~     The aim of the study is to establish the accuracy of a new device designed specifically to~     record and detect cough episodes.~      Cough is an important defense mechanism of the respiratory tract. The presence of chronic~     cough may indicate the presence of underlying diseases, including reflux. Despite the~     increased number of patients suffering from cough in the ENT and GI practice, to date, there~     has been no method/device to objectively assess the frequency of cough episodes in a given~     patient.~      PULMOTRACK-CC, manufactured by KarmelSonix (Haifa, Israel), has recently introduced an~     innovative device that is able to record cough episodes and then automatically detect and~     count them with the help of a specific software program. This study will assess the accuracy~     of this novel cough monitoring and counting technology and validate potential clinical use in~     patients with chronic cough.~   "
175833|NCT01263613|"~     The purpose of this study is to determine if the investigators are able to locate and measure~     certain characteristics in breast cancer tumors that have been treated with paclitaxel that~     may correlate to how well the cancer will respond to the chemotherapy.~   "
175834|NCT01263600|"~     The purpose of this study is to describe participants 6 months to <18 years of age with~     hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and~     Canada and identify predictors of disease activation and progression.~   "
175835|NCT01263587|"~     The primary purpose of this study is to describe participants with hepatitis B virus (HBV)~     infection and identify factors that may cause the disease to activate or worsen.~   "
175836|NCT01263574|"~     This study is designed to determine if the use of 70% ethanol lock solution in central lines~     decreases the rate of central line infections in children with short bowel syndrome. While~     ethanol locks have been used safely in children, there has been no published research to date~     that clearly shows it is of definite benefit in this group of patients.~   "
175837|NCT01263561|"~     Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome:~     IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from~     baseline without medication or additional glaucoma surgery and qualified success defined as~     IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but~     no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual~     acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.~   "
175838|NCT01263548|"~     ADHD in the adult population is associated with several measures of harmful dysfunction. For~     example, adult ADHD is associated with high rates of separation/divorce and never-married~     status, lower educational attainment and occupational achievement, absenteeism, presenteeism,~     and job termination, as well as decreased social function. Individuals with adult ADHD are~     more likely than controls to have a comorbid diagnosis of bipolar disorder, alcohol and~     substance abuse, as well as antisocial personality disorder.~      Psychostimulants are the most frequently employed medications in the treatment of adult ADHD.~     Several psychostimulants are Health Canada and US FDA-approved for the treatment of ADHD~     symptoms in adulthood.~      Hitherto, no trial has evaluated the safety and efficacy of a psychostimulant in the~     treatment of ADHD symptomatology in adult individuals with bipolar disorder.~      Vyvanse is the first prodrug stimulant indicated for the treatment of adult (and pediatric)~     ADHD. Vyvanse is a therapeutically inactive molecule (i.e. prodrug). After oral ingestion,~     lisdexamfetamine is converted to l-lysine, a naturally occurring essential amino acid, and~     active d-amphetamine, which is responsible for the drug's activity. Vyvanse provides a longer~     duration of effect consistent throughout the day with reduced potential for risk of abuse.~     Vyvanse is generally well tolerated with an adverse event profile similar to other~     psychostimulant medications. Available evidence indicates that in most treated subjects,~     Vyvanse is weight-neutral and/or is associated with weight loss. Moreover, in some~     individuals, it is associated with improvement in both glucose and lipid homeostasis.~      The evaluation of safety/tolerability profiles as well as the effectiveness of~     lisdexamfetamine in a real-world population has significant translational value.~   "
175839|NCT01263535|"~     This clinical trial is designed to investigate the performance of SENSIMED Triggerfish®~     during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid~     recording intervals over the 24-hour period.~      The investigation will recruit male and female patients older than 18 years and diagnosed~     with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the~     study. Patients will be considered enrolled in the study upon signature of informed consent.~     A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour~     hospitalisation, are planned for each patient.~   "
175854|NCT01263340|"~     The investigators will describe the characteristics, prevalence, incidence, severity~     co-morbidity and management of patients with chronic obstructive pulmonary disease (COPD) in~     the UK. 100 practices will be sampled amounting to a total study population of about 10 000~     patients. Information will be collected electronically and, where necessary, by a hand search~     of patient records.~   "
175855|NCT01263327|"~     This phase I clinical study was designed to evaluate the safety of novel recombinant HPV~     16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women~     18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV~     vaccine administered intramuscularly according to a 0-1-6 month schedule.~   "
175840|NCT01263522|"~     Health-promoting effects of physical exercise are well-investigated especially for endurance~     activities. However, for different individuals, positive effects have different sizes, even~     non-responders are observed. Other forms of training, such as strength training and interval~     training, are less well investigated. Therefore, a comparative longitudinal training study is~     warranted to examine differences of preventive effects (outcome measures: ergometric~     descriptors of physical performance, established risk factors and prognostic factors for~     cardiovascular diseases) of continuous endurance training, interval training and strength~     endurance training.~      In a second stage, the observed non-responders will perform a different type of training~     (cross-over). It is expected, that besides a comparative general efficacy evaluation of the~     three training types, improved recommendations for optimized individualization of training~     parameters can be formulated.~   "
175841|NCT01263509|"~     The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and~     an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40~     consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on~     study.~   "
175842|NCT01263496|"~     The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once~     daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40~     consecutive weeks in participants who completed a phase 2 dose-ranging study.~   "
175843|NCT01263483|"~     The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily~     (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2~     diabetic patients with uncontrolled blood glucose.~   "
175844|NCT01263470|"~     The purpose of this study was to evaluate the dose-response relationships of alogliptin, once~     daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal~     clinical dose for type 2 diabetic patients.~   "
175845|NCT01263457|"~     This is a National, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth~     hormone treatment from hospital in the UK and to assess the level of adherence of subject~     receiving SAIZEN® via Easypod™.~   "
175846|NCT01263444|"~     The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a~     single agent to prostaglandin monotherapy in patients with either ocular hypertension or~     primary open-angle glaucoma.~   "
175847|NCT01263431|"~     Aim of the study is to compare short term results of 2 surgical treatment for grade 3~     hemorrhoidal disease, namely: pain and postoperative morbidity,complications and~     effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction~   "
175848|NCT01263418|"~     This research study will only include two types of non-Hodgkin Lymphoma (NHL), follicular~     lymphoma or marginal zone lymphoma and participants will be age 70 or older.~      The purpose of this research study is to learn about the safety of the treatment with the~     drug ofatumumab to find out what effects, both good and bad this treatment has on lymphoma.~     Ofatumumab is a monoclonal antibody. Monoclonal antibodies are being used to treat some types~     of cancer. Monoclonal antibodies are a type of protein made in a laboratory that can bind~     substances in the body including cancer cells. Ofatumumab binds to the protein called CD20,~     which is found on B-cells and lymphoma cells.~      The study drug, Ofatumumab, is approved by the United States Food and Drug Administration~     (FDA) for treatment of other types of blood cancer and is not approved for use in patients~     with non-Hodgkin Lymphoma. The use of ofatumumab in this study is considered investigational.~      In addition to learning about ofatumumab, the researchers are interested in learning about~     how this cancer treatment affects daily activities. Participants will be asked to complete a~     Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional~     status, mental health, and level of social support. This assessment will help the health care~     team understand a participant's functional age as compared to a participant's actual age.~      The researchers also want to collect blood samples to study molecules in follicular lymphoma~     cells called 'biomarkers' to learn about how the lymphoma responds to therapy. A biomarker is~     a molecule (for example, DNA or protein) found in the blood or tissues that is a marker for~     disease. In this study, the investigators will measure the changes of the biomarker called~     bcl-2. This biomarker research will only be in subjects with follicular lymphoma.~   "
175849|NCT01263405|"~     The purpose of this study is to determine the ability of a specific imaging method, termed~     Diffuse Optical Spectroscopic Imaging, to provide metabolic and functional information which~     can be used to predict overall response to preoperative (neoadjuvant) chemotherapy in~     patients with sarcomas. Sarcoma patients face comparatively poor response rates to~     chemotherapy and early, non-invasive indications of response could provide physicians with~     the information necessary to make evidence-based changes in treatment strategies. Patients~     who do not demonstrate early signs of response would be spared the unnecessary side-effects~     of an ineffective chemotherapy regimen, and could either be switched to a different regimen~     or undergo surgery~   "
175850|NCT01263392|"~     The primary aim of this study was to determine if using the SpeediCath hydrophilic catheter~     would reduce the incidence of symptomatic urinary tract infections (UTI)in children with~     spina bifida who perform clean intermittent catheterization for bladder management. The~     hypothesis was that the incidence of symptomatic urinary tract infections would be~     significantly reduced (by 25%) in users of the SpeediCath hydrophilic catheter when compared~     to users of a reused polyvinyl chloride (PVC) catheter. Subjects were randomly assigned to~     either starting the study with PVC catheter for 6 months followed by the hydrophilic catheter~     for 6 months or visa versa. Each subject kept a weekly diary recording urinary tract~     infections symptoms, hematuria determined by urine dipstick, physician visits, days of missed~     school and other activities. At the end of each 6 months subjects completed a questionnaire~     recording their comfort and satisfaction in using the PVC or hydrophilic coated catheter. 70~     subjects were randomized and 46 had complete data. There were no differences in febrile UTI,~     antibiotic use, healthcare visits or school days missed. The incidence of self reported UTI~     was lower in the PVC group than the hydrophilic group. 40% of subjects indicated that the~     hydrophilic coated catheter was slippery and difficult to handle compared to 10% for the PVC~     catheter. However overall satisfaction was no different between products. The study results~     are consistent with the current Cochrane Review that there is a lack of evidence to state~     that the incidence of UTI is affected by multiuse or hydrophilic catheter use.~   "
175851|NCT01263379|"~     This trial will create a skin graft, which the investigators call LEAES, using the~     patient's own skin cells that have been genetically engineered in the lab to express a~     missing protein called type VII collagen. The corrected cells will be transplanted back to~     the patient.~   "
175852|NCT01263366|"~     This study, a nonrandomized open-label Phase I safety and exploratory study, will evaluate~     the safety of topical norepinephrine in post-surgical breast cancer patients who are~     undergoing radiation therapy.~      The study will also provide information about whether topical norepinephrine can prevent or~     decrease the severity of the radiation dermatitis experienced by these patients.~   "
175856|NCT01263314|"~     This is a randomized, double-blind, placebo-controlled study. Two panels, each consisting of~     eight participants (8 elderly males with mild to moderate hypertension in Panel A and 8~     elderly females with mild to moderate hypertension in Panel B) will be randomized to receive~     either MK-8266 or matching placebo in a 3:1 ratio. Participants will receive single doses of~     MK-8266 or matching placebo in three treatment periods (Periods 1 through 3). In both Panel A~     and Panel B, doses will escalate in a rising, fixed sequence. In Period 1 (0.3 mg), Period 2~     (0.6 mg), and Period 3 (1.0 mg) once daily doses of MK-8266 or matching placebo will be~     administered. Blood samples will be obtained pre-dose and at selected time points up to 48~     hours post-dose for determination of MK-8266 plasma concentrations.~   "
175857|NCT01263301|"~     Subclavian steal phenomenon is normally observed in patients with stenosis of subclavian~     artery proximal to orifice of vertebral artery(V0). However, uremic patients undergoing~     hemodialysis using vascular access in the arm or forearm may also develop dialysis associated~     steal syndrome(DASS).For patients with symptomatic subclavian steal phenomenon, the treatment~     for these two groups is different. The investigators want to see if the investigators can use~     noninvasive duplex examination instead of invasive conventional angiography to do the~     differential diagnosis.~   "
175858|NCT01263288|"~     The primary aim of the present trial is to study the effect of daily vitamin D~     supplementation on muscular power and force among non-western immigrants living in Oslo,~     Norway, and secondarily to study the effect of musculoskeletal pain and headache.~      The investigators have also prespecified a number of additional research questions about~     anemia, metabolism and bone turnover, inflammation, diabetes, lipids, itching and kidney~     function, which because of multiple comparisons should be interpreted with caution unless the~     statistical evidence for an effect is very strong.~   "
175859|NCT01263275|"~     Among antidepressant treatments, ECT stands as the most effective in treating acute~     depression. However, patient concerns with the cognitive side effects of ECT have encouraged~     the development of new and more focal forms of brain stimulation such as transcranial Direct~     Current Stimulation (tDCS). However, not all patients may respond to this treatment in the~     way that it is currently administered and this has raised interest in finding alternative,~     possibly more optimal ways of administering tDCS. This study will investigate whether tDCS~     stimulation using an alternative electrode montage has antidepressant effects.~   "
175860|NCT01263262|"~     Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the~     chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub on~     the face prior to cutaneous surgery decrease the chances of a post-operative wound infection?~   "
175861|NCT01263249|"~     To determine if the way local anesthetic, or numbing medication, is delivered through a tiny~     tube next to the nerves that go to the thigh affects the strength and sensation in the thigh.~   "
175862|NCT01263236|"~     The purpose of this study is to investigate the safety and tolerability of ascending single~     and multiple oral doses of LY2940094 in healthy male subjects.~   "
175863|NCT01263223|"~     The purpose of this study is to determine the effect of LY2216684 on heart rate and blood~     pressure in research participants with MDD who are being treated with an SSRI (selective~     serotonin reuptake inhibitors). Information about any side effects that may occur will also~     be collected. The duration of participation in this study is approximately 24 days not~     including the screening visit. This study requires 1 clinic confinement of 17 days/16 nights~     and 1 Follow-up Outpatient Visit. A screening visit is required within 30 days prior to the~     start of the study. In both periods 1 and 2, the study involves 4 single daily doses of 18 mg~     LY2216684 or placebo taken as 2 tablets by mouth. In period 3, the study involves four single~     daily doses of 36 mg LY2216684 or placebo taken as 4 tablets by mouth.~   "
175864|NCT01263210|"~     Acute otitis media (AOM) is a common childhood disease, which becomes recurrent in 15-20% of~     the cases. Streptococcus pneumoniae is one of the leading causative agents, and a small~     reduction in the number of AOM episodes has been noted in unselected child cohorts after~     vaccination with conjugate heptavalent pneumococcal vaccine. This study was performed in~     order to investigate whether vaccination could reduce the number of AOM episodes in very~     young, otitis-prone children.~   "
175865|NCT01263197|"~     The purpose of this study is to determine the effect of LY2216684 on heart rate of healthy~     people receiving Albuterol and Propranolol. Information about any side effects that may occur~     will also be collected.~   "
175866|NCT01263184|"~     The studies object is to evaluate the degeneration of overhead sports in wheelchair-using~     athletes. It is assumed that wheelchair users do have more symptomatic shoulder pain compared~     to non disabled athletes.~   "
175867|NCT01263171|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells~     that remain after surgery.~      PURPOSE: This phase II trial is studying giving oxaliplatin, leucovorin, and fluorouracil~     together, before and after radiation therapy and surgery in treating patients with rectal~     cancer that can be removed by surgery.~   "
175883|NCT01262963|"~     The study is a Phase 1, open-label study designed to characterize the absorption,~     distribution, metabolism and excretion of GSK2118436 following administration of a single~     oral 14C labeled dose of GSK2118436 as a suspension in subjects with BRAF mutation positive~     tumors.~   "
175906|NCT01262664|"~     The goal of this clinical research study is to find the highest tolerable dose of~     PROHIBITIN-TP01 that can be given to patients with advanced prostate cancer for which there~     are no standard therapy options. The safety of this drug will also be studied.~   "
175907|NCT01262651|"~     This 9-week study aimed to determine the efficacy, safety and tolerability of nabiximols~     (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled~     persistent chronic pain in participants with advanced cancer.~      Eligible participants were not required to stop any of their current treatments or~     medications.~   "
175908|NCT01262638|"~     This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of~     ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.~   "
175868|NCT01263158|"~     Slow labour progress is common in nulliparous women and is associated with childbirth~     complications and negative birth experiences. Oxytocin augmentation is widely used to treat~     slow labour despite associated risks for the fetus. An ongoing debate concerns whether~     oxytocin should be administered directly or postponed after arrested labour. The overall aim~     is to study labour progress in healthy nulliparous women and to compare childbirth outcomes~     and experiences in women randomised to expectant versus early oxytocin augmentation for slow~     labour progress.~      The hypothesis is that it is to early to start oxytocin treatment when labour progress has~     been slow for 2 to 3 hours in healthy women having their first baby and therefore beneficial~     for childbirth outcomes to postpone oxytocin for another 3 hours. In this randomised~     controlled trial nulliparous women with a normal pregnancy, spontaneous onset of active labor~     at term, and a cervical dilatation of 4 - 9 centimetres on admission to the delivery ward~     were included (n=2,072). All women whose labour did not progress after amniotomy (n=630) were~     randomly allocated either to labour augmentation by oxytocin infusion (Early oxytocin, n=314)~     or to postponement of oxytocin augmentation for another three hours (Expectant, n=316). One~     month postpartum the women received a postal questionnaire concerning their experiences of~     labour and birth. All participating women gave their informed consent. Maternal and neonatal~     outcomes like mode of delivery, postpartum haemorrhage, perinatal lacerations, low Apgar~     score, need of neonatal intensive care and maternal experiences of childbirth were compared~     between the randomised groups.~   "
175869|NCT01263145|"~     This phase I trial studies the side effects and best dose of Akt inhibitor MK2206 (MK2206)~     when given together with paclitaxel and to see how well they work in treating patients with~     solid tumors that have spread to other places in the body and usually cannot be cured or~     controlled with treatment or breast cancer that has spread to other places in the body. Akt~     inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving Akt inhibitor MK2206 and paclitaxel may be a~     better treatment for solid tumors or breast cancer.~   "
175870|NCT01263132|"~     This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3~     clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined~     with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with~     chronic distal diabetic polyneuropathy.~   "
175871|NCT01263119|"~     The purpose of this study is to determine how warfarin might affect LY2216684 and how giving~     LY2216684 might affect warfarin in the body. Information about any side effects that may~     occur will also be collected.~   "
175872|NCT01263106|"~     The primary aim of this study is to confirm that LY2216684 is not an inhibitor of CYP1A2 in~     vivo using theophylline as a probe substrate for the enzyme. Since LY2216684 has been~     observed to increase heart rate in some healthy subjects, this study will also assess heart~     rate when co-administered with theophylline.~   "
175873|NCT01263093|"~     The purpose of this study is to measure how much of the study drugs reach the blood stream~     and how long it takes the body to get rid of them, and determine how clopidogrel and~     LY2216684 might affect each other in the body. Information about any side effects that may~     occur will also be collected.~   "
175874|NCT01263080|"~     Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the~     effects of adding mirtazapine and folic acid to existing therapy for patients with~     schizophrenia~   "
175875|NCT01263067|"~     The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces~     posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma~   "
175876|NCT01263054|"~     The primary objective of this randomized controlled trial is to evaluate the safety and~     efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine~     using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual~     Analog Scale (VAS) at 6 months post treatment/randomization and the TransDiscal System will~     be compared against medical management (standard of care).~   "
175877|NCT01263041|"~     effects of enteral l-arginine to decrease feeding intolerance and risk of NEC in neonates via~     its role as a NO precursor. Also, enteral glutamine which may play a role as an~     immunomodulator on preterm neonates. all these had never been studied in developing countries~     where sepsis and nec act as a major participant in mortality rates.~   "
175878|NCT01263028|"~     Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D~     deficiency in the Chronic Kidney Disease population requiring recombinant human~     erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of~     erythropoietin required to maintain a nonanemic state.~   "
175879|NCT01263015|"~     The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50~     mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil~     fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48~     weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1~     infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and~     development of viral resistance will be evaluated.~   "
175880|NCT01263002|"~     An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and~     Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B~     Associated Hepatocellular Carcinoma~   "
175881|NCT01262989|"~     It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,~     02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions~     receive, in each period, the test formulation or the reference formulation~   "
175882|NCT01262976|"~     The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline~     (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human~     Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis~     endemic region.~      Subjects will be followed-up for 3 years.~      Subjects will be enrolled in 3 cohorts:~        -  HIV-positive adults on highly active antiretroviral therapy~        -  HIV-positive adults not on highly active antiretroviral therapy~        -  HIV-negative adults~      Each cohort will have 2 groups.~   "
175884|NCT01262950|"~     The investigators plan to conduct a first-stage experiment by recruiting ten subjects,~     including five PD patients and five non-PD patients. In the beginning, the information~     collected by the portable motion detector is used to compare the difference in the activities~     performed by PD and non-PD patients. Besides, the algorithm will be developed to identify the~     gait patterns of PD patients. Once the system detects the abnormal gaits, such as shuffling~     and festinating steps or freezing of gait, auditory cues will be given to the PD patients and~     caregivers by their sides. It can help the patient to maintain normal gait and improve the~     effectiveness of rehabilitation, as well as preventing falls in daily activities. Moreover,~     in case of accident falls, the real-time fall detection mechanism alerts the nearest~     caregiver for instant support and delivers this information to the remote family members and~     medical personnel.~      After that, a second-stage experiment will be carried out by recruiting another five PD~     patients. By comparing the gait patterns identified by the system against those identified~     manually by the staff, the performance of the proposed system on fall prevention will be~     examined. For the patients and their family members, the developed system enhances the~     patients' safety in their daily activities. As for the medical personnel, it serves as an~     affordable tool that benefits the rehabilitation of PD patients in an easy manner.~   "
175885|NCT01262937|"~     The goal of the project is to determine whether confocal endomicroscopy can be used to~     identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared~     with histologic specimens as a reference. The project will evaluate those at risk for or with~     known Barrett's esophagus, and those with known or suspected biliary strictures. It is our~     hypothesis that we will be able to identify between neoplastic and nonneoplastic tissue.~   "
175886|NCT01262924|"~     The purpose of this study is to assess the immunogenicity and reactogenicity of~     GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals)~     reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content~     diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™~   "
175887|NCT01262911|"~     SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic~     inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The~     objective of this study is to test if SRT2379 may be a novel compound for the treatment of~     inflammatory disorders in man.~   "
175888|NCT01262898|"~     GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and~     MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up~     to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater~     prevalence than placebo, and no significant abnormal vital sign, ECG, or clinical laboratory~     findings. Pharmacokinetic parameters were linear and approximately dose proportional over the~     range of doses administered. Single doses of 50 mg - 150 mg GSK962040 significantly increased~     the rate of gastric emptying up to 40% as measured by the 13C octanoic acid stable isotope~     breath test. A similar effect of 50 mg and 125 mg on gastric emptying was observed throughout~     repeated dosing to healthy volunteers for 14-days.~      The aims of the present investigation (MOT114479) are to assess the pharmacodynamic effects~     (gastric emptying and symptoms), safety, tolerability, and pharmacokinetics of GSK962040~     after 28 days of once-daily dosing in Type I and Type II diabetic subjects with~     gastroparesis. An additional aim is to characterize the dose/exposure - pharmacodynamic~     effect relationship.~   "
175889|NCT01262885|"~     GSK2251052 ((S)-3-(aminomethyl)-7-(3-hydroxypropoxy)-1-hydroxy-1,3-dihydro-2,1-benzoxaborole~     hydrochloride) is a Gram negative antibacterial compound currently in development for the~     treatment of hospital acquired Gram negative infection (including E. coli, K. pneumoniae, and~     Enterobacter spp.) This study will be conducted in two (2) parts, with single oral doses~     being explored in Part A (500, 1000, and 2000 mg) and repeat oral doses (1000 and 2000 mg,~     b.i.d.) being explored in Part B. Parts A and B will be single-blind, randomized,~     placebo-controlled, dose-rising studies in healthy subjects to evaluate the safety,~     tolerability and pharmacokinetics of oral GSK2251052.~   "
175890|NCT01262872|"~     This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of~     GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and~     co-administered with other routine paediatric vaccines in infants in The Gambia. Two~     formulations containing different doses of pneumococcal antigen and two different schedules~     will be tested in infants.~   "
175891|NCT01262859|"~     Induction chemotherapy is gaining momentum in the management of locally advanced squamous~     cell carcinoma of the head and neck (SCCHN). The combination of docetaxel, cisplatin, and~     5-FU (TPF) was superior compared with PF in a Phase III clinical trials73,74. We have~     completed a Phase II clinical trial that showed that docetaxel, cisplatin, and cetuximab~     (TPE) is highly active and well tolerated as induction chemotherapy in SCCHN (Argiris et al.~     ASCO 2008; A6002). Preliminary survival results are very encouraging. 39 patients were~     enrolled and with median follow up 26 months the 2-year PFS was 70% and the 2-year OS 84%.The~     combination of chemotherapy plus cetuximab is already a standard treatment in recurrent or~     metastatic SCCHN47. Therefore, TPE can be used as the platform for the addition of novel~     agents.~      EGFR and VEGF are among the most important and validated molecular targets in cancer therapy.~     The incorporation of novel targeted therapies to chemotherapy and radiotherapy is of~     particular interest in head and neck cancer, and may improve efficacy without significantly~     increasing toxicity. A Phase III trial of carboplatin/paclitaxel/bevacizumab with or without~     cetuximab in advanced NSCLC has been proposed by SWOG. Bevacizumab is currently being~     investigated in SCCHN with promising results. A Phase II study investigating the combination~     of pemetrexed and bevacizumab (UPCI 05-002) as well as a Phase II trial of cetuximab and~     bevacizumab (UPCI 05-087) in recurrent or metastatic SCCHN are ongoing at the University of~     Pittsburgh with encouraging results (ASCO 2008 and ASCO 2009). In this study, 32 have been~     already enrolled. There was only 1 patient with grade 3 hemorrhage. The objective response~     rate is 20%, the median PFS 2.8 months and the median OS 8.1 months.~      In order to further improve the efficacy of TPE and the rate of complete responses we propose~     to add bevacizumab to the TPE followed by XPE regimen we developed at the University of~     Pittsburgh. Due to non-overlapping toxicities and based on our prior experience we anticipate~     that the regimen will be well tolerated. Moreover, we plan to obtain tumor biopsies and blood~     samples in the first cycle and evaluate the modulation of biomarkers post combination~     therapy. Data from induction with TPE (presented at ASCO 2009) indicate the potential~     significance of cytokine levels in patient outcome. Also, we will evaluate the feasibility of~     subsequent concurrent radiation, cisplatin, cetuximab and bevacizumab. Patients with stable~     disease in the primary could be considered candidates to surgical resection at the discretion~     of their physician, if the tumor is resectable.~   "
175892|NCT01262846|"~     The overall goal of this study is to compare the safety and immunogenicity of trivalent~     Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. Our~     hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used~     vaccine~   "
175949|NCT01262105|"~     The objective of this study is to determine whether the Air Barrier System device reduces~     airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal~     procedures.~   "
175893|NCT01262833|"~     The study will address the role of internal pudendal artery disease in erectile dysfunction~     (ED), and whether it might eventually be amenable to intervention with stenting. There is~     currently a small trial investigating the potential benefit of stenting for erectile~     dysfunction, but the relationship between pelvic arterial stenoses and erectile dysfunction~     is not yet proven. The investigators intend to perform angiography on patients both with and~     without erectile dysfunction, to see whether internal pudendal artery disease is more common~     in the population with erectile dysfunction. In addition to angiography, stenoses will be~     examined using fractional flow reserve. The degree of internal pudendal artery disease will~     then be correlated with the degree of erectile dysfunction using a validated questionnaire,~     the International Index of Erectile Function (IIEF). Patients will then complete IIEF~     questionnaires for 5 years to assess the relationship between internal pudendal artery~     disease and progression of erectile dysfunction.~   "
175894|NCT01262820|"~     This is an open label Phase II Trial that using the investigational anti-cancer agent,~     Pazopanib to see whether non-squamous non-small cell lung cancer will respond to its use by~     decreasing the size of the tumor or stopping its growth.~   "
175895|NCT01262807|"~     This a randomized controlled study to test the hypothesis that patients who perform in-cast~     exercises will have superior range of motion immediately post-cast removal, without a~     concomitant increase in complication rate when compared with a control group who receives~     standard post cast care which does not include the intervention exercises.~   "
175896|NCT01262794|"~     To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc)~     administration of CDP6038 to Japanese subjects.~      To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of~     CDP6038 to Japanese subjects~   "
175897|NCT01262781|"~     The obesity epidemic has reached down into the infant and toddler age group. Dietary~     indiscretion during pregnancy, particularly in our current food environment, is a major risk~     factor for both gestational diabetes and neonatal macrosomia (>4kg newborns), which is itself~     a risk factor for obesity and metabolic syndrome in the offspring, possibly even during~     childhood. Temporal increases in fructose consumption in the last two decades coincide with~     temporal increases weight gain during pregnancy and with increased birth weight, including a~     higher prevalence of macrosomic newborns. Our central hypothesis is that higher fructose~     consumption during pregnancy is a risk factor for infant obesity and metabolic syndrome.~   "
175898|NCT01262768|"~     Portion size measurement aids (PSMAs) are tools that facilitate the estimation of food~     servings. The objectives of this study are to determine (a) if food portion size estimation~     accuracy differs when using a two dimensional (2D) PSMA (actual-size photos called Portion~     Size Cards) compared to a 3D PSMA (Portion Size Kit) and (b) whether differences exist in the~     short-term usefulness of and satisfaction with these PSMAs in a sample of parents of~     overweight children and youth. We hypothesize that the group that receives the 3D PSMAs will~     be more accurate in food portion size estimation and will be more satisfied with the tool~     compared to the group that receives the 2D PSMAs.~   "
175899|NCT01262755|"~     DESCRIPTION: Minimal data exists on the prevalence of gastroesophageal reflux disease in~     minority populations. Specific objectives of this K24 research project are to: (1) Provide an~     estimate of the prevalence of gastroesophageal reflux disease in an urban, African American~     population; (2) Determine whether specific risk factors including diet, tobacco use, physical~     activity, and psychosocial stress are important in the targeted population. We will also~     measure height, weight, and waist/hip circumference to determine the impact of central~     obesity on reflux. PUBLIC HEALTH RELEVANCE: This research will help doctors to understand the~     frequency and risks for esophageal reflux disease (heartburn) in African Americans.~   "
175900|NCT01262742|"~     Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the~     most commonly uterotonic drug used to prevent and treat PPH in North America, however, there~     are some limitations to its use. Oxytocin has a very short duration of action, which requires~     a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians~     and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of~     carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post~     partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts~     4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater~     efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin~     has not yet been published.~      We hypothesize that a dose-response study will establish the minimum dose of carbetocin~     required to produce appropriate contractility in 95% of the women (ED95) undergoing elective~     cesarean delivery.~   "
175901|NCT01262729|"~     In this clinical trial will be checked, whether 2 hour ventilation with xenon has~     neuroprotective effects in patients with out of hospital cardiac arrest and successful~     cardiopulmonary resuscitation~   "
175902|NCT01262716|"~     This study will assess safety and ergonomics/engineering design of a novel cancer treatment,~     Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on primary~     and metastatic tumors involving the skin, in particular to improve the functionality,~     efficiency and wearability of the light delivery device (LDD) as well as the overall~     treatment in subjects with chest wall recurrences of breast cancer. An ongoing study (IRB#~     8227), sponsored by a Susan G. Komen Breast Cancer Foundation grant, using a 1st generation~     LDD device has evaluated and determined a dose-limiting toxicity of CLIPT for subjects with~     chest wall recurrences of breast cancer.~      A Diomed laser will be the device used in this study. The Diomed laser will deliver 630 nm~     (red spectrum) light through a Fiber Optic Patch. The Fiber Optic patch will be compatible~     with the laser, delivering light to a designated region on the patient's skin.~   "
175903|NCT01262703|"~     To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native~     coronary arteries.~   "
175904|NCT01262690|"~     This study will examine whether a single dose of PF-05230901 is safe and well tolerated when~     given to healthy volunteers by injection under the skin. An additional objective is to~     measure the blood concentrations of PF-05230901. Each dose will be tested in a different~     group of subjects starting from the lowest dose.~   "
176175|NCT01259154|"~     Introduction: The aim of the study was to investigate the effectiveness of combined bipolar~     radiofrequency surgery of the tongue base (RFBT) and uvulopalatopharyngoplasty (UPPP) in a~     single session for obstructive sleep apnea (OSA) and to determine whether this combination is~     safe and well tolerated.~   "
175909|NCT01262625|"~     This randomized, controlled, diagnostic, multicenter trial will compare two diagnostic~     imaging pathways--coronary computed tomography angiography (CCTA) and single photon emission~     tomography (SPECT) myocardial perfusion imaging (MPI)--to determine the incidence of major~     adverse coronary events (MACE), defined as myocardial infarction (MI) or cardiac-related~     death, and cross-over to revascularization. CCTA may be used to direct patients with symptoms~     of stable angina or angina equivalent to optimal medical therapy (OMT). The use of CCTA as a~     diagnostic tool for angina symptoms will be associated with no increase in MACE or~     revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional~     insights into alternate explanations of chest pain, and increased cost-effectiveness in~     comparison with use of SPECT MPI/invasive coronary angiography (ICA).~   "
175910|NCT01262612|"~     In some patients with cancer there are also cancer cells in the abdominal cavity or between~     the lung membranes. These cancer cells create too much moisture in the abdominal cavity or~     between the lung membranes. If there is fluid in the abdominal cavity (ascites fluid) this~     can bring on abdominal distension, abdominal pain, loss of appetite, fatigue, bloating and~     sometimes wheezing. Too much fluid between the lung membranes (we call this pleural fluid)~     gives breathlessness, chest pain and coughing. The use of diuretics may offer a small group~     of patients symptom reduction. Additionally, the fluid can be drained through a needle~     puncture or fluid collection (through a biopsy). But usually, the moisture quickly returns.~      Previous research done in this hospital with cediranib showed that with some patients with~     cancer who suffered from fluid in the abdominal cavity or between the lung membranes, this~     moisture reduces while using this drug. It also reduced the symptoms caused by this excessive~     moisture.~      The current study is conducted to see whether patients with cancer and fluid in the abdominal~     cavity or fluid between the lung blades benefit from using cediranib. This involves not only~     whether the amount moisture reduces, but also if the complains decrease. In addition, we will~     carefully consider the possible side effects of cediranib.~   "
175911|NCT01262599|"~     Pedicled transverse rectus abdominus myocutaneous (TRAM) flaps are the most common~     post-mastectomy breast reconstructive surgeries that utilize the patient's tissue. The~     pedicled TRAM flap involves harvesting skin, fat, and muscle from the abdomen to create a new~     breast. TRAM flap complications include fat necrosis of the reconstructed breast, delayed~     wound healing, and abdominal bulge or hernia. Pain at the abdominal donor site is a major~     contributor to the need for four to five days of post-operative hospital stay. Pulsed~     electromagnetic field (PEMF) technologies have been useful as adjunctive therapy for the~     treatment of delayed union fractures, chronic wounds and post-operative pain. PEMF devices~     are economical and disposable, and can be incorporated unobtrusively in standard~     post-operative dressings. The investigators have recently reported, in a double-blind,~     placebo-controlled study on breast reduction, that post-op PEMF therapy produced a~     significant decrease in pain and pain medication use, along with a concomitant decrease in~     IL1-beta in the wound bed.~      The proposed study seeks to determine whether similar results will be obtained after a~     significantly more extensive surgical procedure, like the TRAM flap. Patients scheduled for~     pedicled TRAM flap breast reconstruction of a single breast immediately following mastectomy~     will be enrolled in this double-blind, placebo-controlled, randomized study. Subjects will be~     assigned to one of two groups: a treatment group with active PEMF devices and a placebo group~     with sham devices that deliver no PEMF. PEMF and sham devices will be taped over both the~     breast reconstruction and abdominal donor sites. Patients will keep the devices in place for~     their hospital stay and for a total of two weeks. The investigators hypothesize that subjects~     in the PEMF treatment group compared to placebo will have a faster reduction in pain, take~     less pain and nausea medications, have lower levels of IL1-beta in wound exudate, have a~     shorter hospital stay, and have less wound-healing complications.~   "
175912|NCT01262586|"~     This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles~     between vildagliptin and glimepiride.~   "
175913|NCT01262573|"~     This study compares outcomes among patients having a total laparoscopic hysterectomy. This~     involves removing the uterus and cervix using a laparoscopic or keyhole technique. The top of~     the vagina is routinely sutured closed after this procedure and this study is comparing two~     different suture materials for this purpose. One suture material is a barbed suture that has~     the advantage of maintaining good tension and closure on the wound. The other is a standard~     smooth suture that is commonly used for this procedure. The investigators are comparing the~     time it takes to close the vaginal cuff, as well as bleeding after surgery and the healing of~     the top of the vagina.~   "
175914|NCT01262560|"~     RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused by chemotherapy~     and radiation therapy. It is not yet known whether Manuka honey is more effective than~     standard care in preventing pain.~      PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well it~     works in preventing esophagitis-related pain in patients receiving chemotherapy and radiation~     therapy for lung cancer.~   "
175915|NCT01262547|"~     This study evaluates micrografting using a harvesting and grafting process that has been~     designed by Momelan Technologies. The overall concept is to harvest several small pieces of~     skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a~     commercially available suction blister device, adhere them to a sterile elastomeric substrate~     and is then place it on a recipient area prepared by epidermal dermabrasion (removal of the~     epidermis).~   "
175916|NCT01262534|"~     The purpose of this study is to assess the clinical profile of patients with moderate to~     severe psoriasis in Spain. The primary objective is to analyze the clinical profile of~     patients with moderate to severe psoriasis, as defined by a set of conditions (obesity,~     hypertension, diabetes, abnormal amounts of lipids in the blood, cardiovascular disease,~     etc.) and its correlation to the patients' quality of life. The secondary objectives are to~     describe the demographic characteristics and habits of the patient, to evaluate the clinical~     characteristics of the disease, and to describe the diagnostic and therapeutic procedures~     being used in standard clinical practice and the patients' expectations for these therapies.~   "
175917|NCT01262521|"~     An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most~     notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion~     (IR) injury and hypertension. The nutritional aspects of these cardioprotective effects are~     particularly intriguing since nitrate and nitrite are abundant in our everyday diet.~      Whether increasing the circulating pool of nitric oxide and nitrite by dietary nitrate offers~     a novel mechanistic approach to regulate mobilization of circulating angiogenic cells and~     thus regenerative processes in cardiovascular medicine is not known. Thus, in the present~     study, we tested whether oral application of nitrate leads to an enhanced number of~     circulating angiogenic cells and whether this is associated with an improvement in~     endothelial function.~   "
176176|NCT01259141|"~     Mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming~     more and more resistant to macrolide. The study aim is to optimize anti-infection therapy.~   "
175918|NCT01262508|"~     Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice~     unexpected deterioration of cardiovascular function remains a serious problem and an~     important cause of death. Novel perspectives in reflex testing of the autonomic nervous~     system might be useful to protect some patients from cardiovascular events by detecting~     cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings is~     nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is~     evidence that additional analyses of pulse wave characteristics might be a valuable source of~     information to generate additional insights into the cardiorespiratory status of the patient.~     Herein, we aim to develop novel algorithms in order to protect in-hospital patients from~     cardiovascular events in consequence of hemodynamic instability in the future.~   "
175919|NCT01262495|"~     we will use testicular tissue from patient who underwent orchidectomy due to medical reasons~     and test the viability of the tissue after cryopreservation and de-freezing.~   "
175920|NCT01262482|"~     In Spain, the gastric carcinoma is the 5th most frequent malignant tumor in women and the 6th~     in men, and represents the 3rd cause of cancer-related deaths amongst women and the 4th~     amongst men. The average of 5-year survival rate in Spain is under 30%. The main reason of it~     is that, despite carrying out an adjuvant treatment, more than the 50% will present relapsed~     disease.~      Sorafenib has been the first RAF inhibitor, both of RAF-1 and B-rRAF and its b-RAF variant~     V600E. Moreover, it has shown its ability to inhibit other tyrosin-quinase receptors as VEGFR~     2 and 3, c-kit, Flt-3 or PDGFR. Its activity has been clearly proven in clear cell renal~     carcinoma.~      The mechanism by which Sorafenib seems to act is not because of the existence of a mutation~     of RAS or RAF, but because as there is a VHL shortage the HIP produces a VEGF, bFGF or TGF~     overexpression that produces in turn a hyper-stimulation on the RAF/ERK/MEK pathway.~      The RAF/MEK/ERK pathway and angiogenesis seem to be clearly involved in the gastric carcinoma~     tumorigenesis and progression. Because of that, it seems interesting to associate Sorafenib~     to an oxaliplatin-based chemotherapy, which has shown its effectiveness in relapsed patients~     after receiving cisplatin-based schemes. Moreover, there is a phase 1 trial confirming the~     tolerance of the oxaliplatin and Sorafenib association, describing partial responses amongst~     gastric cancer patients previously treated with cisplatin.~   "
175921|NCT01262469|"~     GERICO 09/0907 is a Phase II multicentric trial evaluating the toxicity and activity of the~     combination of lapatinib and capecitabine in locally advanced or metastatic breast cancer~     over expressing HER2 for patients aged ≥ 70 who have failed after one line of chemotherapy in~     combination with trastuzumab.~      Due to the minimal participation of older people in clinical trials, there is a lack of data~     to make evidence-based decisions regarding chemotherapy in this indication.~      The study is designed to investigate whether elderly patients with locally advanced or~     metastatic breast cancer over-expressing HER2 could take advantage of the combination~     lapatinib and capecitabine in term of clinical benefit, and with no adverse effects and no~     detrimental impact on functional status (part of geriatric assessment).~      The main objective is to assess clinical benefit (defined at 4 months as complete response,~     partial response or stable disease), safety and preserved geriatric independence (main~     objective is a bi-criteria or composite criteria).~   "
175922|NCT01262456|"~     The purpose of this trial was to confirm/establish long-term safety and efficacy of~     desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further~     evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.~   "
175923|NCT01262443|"~     The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial~     flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual~     success of the procedure.~   "
175924|NCT01262430|"~     The OtisMed Custom-fit system for total knee replacements replaces conventional surgical~     techniques for templating and intra-operative instrumentation with a preoperative virtual~     surgery process that utilizes 3D models of the affected knee from a pre-operative MRI or CT~     image. The 3D model of the affected knee is processed with a proprietary algorithm that~     virtually alters it to its pre-arthritic state by filling articular defects, removing~     osteophytes, and approximating the joint surface. The software then shape matches the knee~     replacement femoral and tibial components to the preathritic knee model and aligns the~     femoral component to the functional flexion-extension axis of the femur. The final~     preoperative step is the machining of custom biocompatible plastic cutting blocks that fit~     the arthritic knee. These cutting blocks are used during the knee replacement surgery to~     guide the bone cuts so that the replacement components are aligned for the individual~     patient.~      In this study we propose to compare patients who have received total knee replacement~     components with the OtisMed Custom-fit procedure to those who have had the same components~     implanted in the conventional manner with Computer Assisted Surgery (CAS). The primary~     outcome will be micromotion of tibial and femoral implants at 1 and 2 years after surgery.~     Secondary outcomes will include subjective outcomes, accelerometric gait analysis, bone~     mineral density, full leg alignment, change in intra-operative frontal plane alignment,~     intra-operative deviations from the surgical plan, surgery duration, OR turnover time, number~     of instrument pans used, and length of hospital stay.~   "
175925|NCT01262417|"~     The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for~     the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer~     requiring two-stage surgery for the resection of hepatic metastases.~      Eligible patients will be randomly assigned to one of 2 arms:~        -  Seprafilm group (receiving resorbable barrier membrane during the first surgery)~        -  No-treatment control group (without seprafilm barrier during the first surgery)~      The primary objective is to establish, in patients with colorectal cancer requiring two-stage~     surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier~     membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second~     operation.~      This study is a prospective multicentric phase II, controlled, randomized and non comparative~     trial.~      A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be~     assigned to the no-treatment control group. The inclusion period should be approximately 18~     months. The follow up period after the second surgery will be 3 years.~   "
176177|NCT01259128|"~     The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years~     or older nocturic patients.~   "
176178|NCT01259115|"~     The purpose of this study is to assess the pharmacokinetics of buprenorphine and its~     metabolites in the presence and absence of ketoconazole.~   "
175926|NCT01262404|"~     Three groups of subjects are trained to practice mindfulness meditation, compassion~     meditation, or attend a health training control class. Individuals from each group will~     undergo structural and functional brain imaging before and after training. The hypothesis is~     that the compassion meditation group will show the largest changes in brain structure and~     function. In a second series of experiments, the subjects practicing a Tibetan meditation~     practice will be undergo MRI thermometry imaging to construct detailed three dimensional~     temperature maps of their bodies before, during, and after they perform this practice.~   "
175927|NCT01262391|"~     This single-dose study will investigate how well solifenacin suspension is taken up, how long~     it stays in the body and how well it will be tolerated in children and adolescents aged 5-17~     years with symptoms of overactive bladder.~   "
175928|NCT01262378|"~     Prospective, non-randomized, controlled study to investigate the clinical outcome of surgery~     using the Harmonic knife vs the HF knife in patients requiring abdominoplastic surgery or~     body lift (Lockwood)~   "
175929|NCT01262365|"~     The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the~     treatment of subjects with Systemic Lupus Erythematosus (SLE)~   "
175930|NCT01262352|"~     The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance~     index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the~     G551D-CFTR mutation on at least 1 allele.~   "
175931|NCT01262339|"~     Primary focal hyperhidrosis (excessive sweating) is a debilitating condition affecting~     approximately 3% of the population in the United States. Not only that it is a major social~     embarrassment to affected individuals, it also has significant negative impacts on career,~     school, and relationship. Botulinum toxin A (BTX-A), a sterile neurotoxin purified from~     Clostridium bacteria, was approved by the U.S. Food & Drug Administration in 2004 for the~     treatment of severe focal axillary hyperhidrosis that does not respond to topical~     antiperspirants. It is becoming a promising treatment for many patients suffering this~     condition. Over the past decade, the medication has also been used effectively for many other~     forms of focal hyperhidrosis such as the hands, feet, forehead, scalp and groin.~     Unfortunately, BTX-A injection for primary focal hyperhidrosis of the palms and soles are~     often limited by pain and post treatment muscle weakness associated with the procedure.~     Recent studies have demonstrated that BTX-A can be delivered across the skin via electric~     current using a medical device, called iontophoresis (FDA 510(k) clearance # K042590 or~     Phoresor IIPM700). Studies with limited number of patients have demonstrated promising~     results with this new treatment.~   "
175932|NCT01262326|"~     All subjects will be evaluated by the Research Nurse at the Clinical Translational Research~     Center (CTRC) Outpatient Clinic to obtain informed consent, a brief medical history, weight,~     body mass index, waist/hip circumference and vital signs. Additionally, blood will be drawn~     at this visit to screen for renal dysfunction (Chem 10), liver disease (liver function tests~     (LFT's)), thyroid dysfunction (TSH), diabetes mellitus (HbA1C), and chronic inflammatory~     states (erythrocyte sedimentation rate). Subjects recruited to the study will be placed on a~     low-carbohydrate diet (<20 g/d without caloric restriction) designed either to promote weight~     loss or maintain weight stability for fourteen days prior to the protocol or they will~     consume a typical Western diet designed either to promote weight loss (restricted by 1300~     kcal/d in the final fourteen days) or maintain weight stability for twenty-one days. Subjects~     recruited to the study will be lean, overweight, or obese and also may carry a diagnosis of~     NAFLD. Target accrual for total enrollment for this project will be set to 80 subjects to~     accommodate attrition and screen failures. The details of the low-carbohydrate diet have been~     discussed in consultation with Linda Brinkley, nutrition staff of the CTRC. Subjects chosen~     to undergo carbohydrate-restriction will have a teaching session with a CTRC dietician.~     Subjects will then initiate dietary carbohydrate-restriction on their own and keep a daily~     dietary record for seven days. At the end of seven days, the dietary record will be analyzed.~     The CTRC will then prepare all meals for the final seven days of the diet in accordance with~     daily caloric intake calculated from the dietary record. Calorie-restricted participants will~     keep a dietary record for one week while eating a typical Western diet. The dietician will~     analyze this record and meals restricted by 1300 kcal/d will be prepared by the CTRC for the~     final fourteen days of the diet. Alternatively, some subjects eating a typical Western diet~     may consume prepared meals with a fixed content of carbohydrate, fat, and protein that is~     unrelated to their pre-study dietary intake. In this scenario, the dietary carbohydrate~     content may be varied between 30 and 60% to provide information on differences in hepatic~     metabolism under conditions of differing, but clinically sustainable, carbohydrate intake.~     All participants will be admitted to the CTRC the night prior to the study and begin an~     overnight fast after dinner. Between 18:00 and 09:00, subjects will receive two stable~     isotope tracers orally: [U-13C]propionate at 08:00 (three 400 mg doses given over 1 hour) and~     70% 2H2O at 22:00, 02:00, and 06:00. During the study subjects will also be given 0.5% 2H2O~     ad libitum. Two 500 mg acetaminophen tablets will also be given at 08:00. Between 08:00 and~     09:00 subjects will undergo measurement of their respiratory quotient (RQ) using the CTRC~     indirect calorimeter (Delta Trac II).. Subjects will then have an intravenous catheter placed~     and an infusion of tracer amounts of [3,4-13C2]glucose, [1,2-13C]β-hydroxybutyrate and~     [3,4-13C]acetoacetate will be initiated. At 1 ½ and 2 hours after initiation of the infusion,~     a 50 cc blood draw will be performed. Voided urine will be collected every hour after~     ingestion of acetaminophen until the protocol concludes. The subject will then be given a~     meal and discharged from the CTRC, marking the completion of the protocol. The collected~     blood and urine will be transported by the research coordinator to the Advanced Imaging~     Research Center lab for analysis by MRS. Another blood draw (approximately 10 cc) will be~     done in conjunction with the final MRI in order to measure changes in the lipid profile after~     the diet intervention. The visits in their entirety will be as follows:~      1 screening visit: 20 minutes~        1. dietician visit: 20 minutes~        2. MRS visits: 45 minutes each~      1 (optional) overnight visit: 20 hours~   "
175933|NCT01262313|"~     There remain important barriers to the translation of the programs like the Diabetes~     Prevention Program to public health. There is a lack of established lifestyle intervention~     programs as they are resource and time intensive, exceeding both the resources and the~     training of most primary care providers. A solution may be the implementation of lifestyle~     intervention programs in the community setting that are unrelated to primary medical care. A~     community based program at a public facility may extend the reach of lifestyle intervention~     to those unable to obtain these services from an established medical facility. Community~     lifestyle intervention to modify dietary, physical activity, and behavioral factors may be a~     promising strategy for weight management and the reduction of risk for metabolic disease. In~     this validation study we will assess pre and post intervention to identify whether measurable~     changes can be detected in body weight, body composition, markers of metabolic disease and~     quality of life after participation in the Healthy Creations, a community based lifestyle~     intervention program presented by Center Court Fitness Center of the Grand Forks Park~     District and Altru Health System.~   "
175934|NCT01262300|"~     This is an ancillary study to a randomized controlled trial of high dose vitamin D in older~     long-term care residents (NCT01102374). In this study, a subset of trial subjects will~     receive the zoster vaccine and the investigators will determine the immunological response to~     the vaccine in this older, frail population, as well as the association between vitamin D and~     immunological outcomes.~   "
175935|NCT01262287|"~     The purpose of this study is to evaluate whether dutasteride is safe and effective for~     reducing alcohol use in male drinkers who want to stop or reduce their drinking. The~     investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and~     that, compared to placebo treatment, dutasteride will result in a greater reduction in the~     amount of alcohol consumed per week. The study sample size is of a pilot scale and is~     designed to provide additional support for the study hypothesis and provide an estimate of~     likely effect sizes in order to design a more definitive study.~   "
175936|NCT01262274|"~     The Aim of this study is to validate a treatment of anastrozole in combination with~     tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although~     pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has~     limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent~     administration of low-dose cytotoxic agents, is not only target tumor cells but also~     inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to~     metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole~     (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for~     postmenopausal breast cancer will be conducted.~   "
175937|NCT01262261|"~     Probuphine (buprenorphine implant) is an investigational implant placed just below the skin~     containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a~     6-month, open-label, re-treatment study that will confirm the safety and efficacy of~     Probuphine in patients who have previously completed the 6-month PRO-806 study with either~     Probuphine, placebo or sublingual buprenorphine.~   "
175950|NCT01262092|"~     This study involves inducting treatment seeking opioid dependent participants onto~     buprenorphine. Once the participant reaches a stable dose they will receive either placebo or~     gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant~     undergoes a 10-day buprenorphine detoxification.~   "
176002|NCT01261416|"~     The primary objective of this study is to determine the pharmacokinetic profile of a loading~     dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm~     infants with seizures. Secondary objectives are to evaluate the safety and efficacy of~     levetiracetam in term and preterm infants with seizures.~   "
175938|NCT01262248|"~     Recent studies have shown that narrow-band imaging (NBI) is a powerful diagnostic tool for~     the differentiation between neoplastic and non-neoplastic colorectal polyps. The aim of the~     present study is to develop and evaluate a computer-based method for automated classification~     of small colorectal polyps on the basis of vascularization features.In a prospective study~     207 polyps with a size of 10mm or smaller should be detected by a zoom NBI colonoscopy. These~     polyps were imaged and subsequently removed for histological analysis. the polyp images were~     analyzed by a computer algorithm. The proposed computer-based method consists of several~     steps: preprocessing, vessel segmentation, feature extraction and classification. The results~     of the automatic classification (sensitivity, specificity, negative predictive value,~     positive predictive value and accuracy)were compared to those of human observers, who were~     blinded to the histological gold standard.~   "
175939|NCT01262235|"~     This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at~     multiple clinical centers. The study is designed to determine the safety, tolerability and PK~     of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to~     standard therapy or for whom there is no standard therapy. After the determination of the~     maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with~     refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.~   "
175940|NCT01262222|"~     The purpose of this study is to look at a new method for finding out if patients have a risk~     of heart complications from surgery. At the present, to find out if patients have a risk of~     heart complications from surgery, look at whether the patient has heart disease, diabetes,~     kidney problems, and stroke. The investigators hope that this study will confirm a new, safe~     test to help us predict the risk of surgery.~   "
175941|NCT01262209|"~     Our team is interested in what can be done to improve the functioning of patients who suffer~     from glaucoma, a chronic and irreversible eye disease. Patients with vision loss as a result~     of this disease may feel like they have been 'given up on', or lost to our medical system~     when no further interventions can be offered to treat their eye disease. It is our intent to~     investigate what alternatives we can provide our patients, instead of simply saying, 'nothing~     more can be done'. We have learned from studies done on other chronic eye diseases, like age~     related macular degeneration, that low vision rehabilitation can improve visual function.~      What exactly is low vision? It can involve a loss of visual acuity, making activities such as~     reading or writing a challenge; it can involve loss of contrast sensitivity, making shapes~     and edges hard to discern, like those of a stair edge, or person's face. It could also~     involve a loss of peripheral, or side vision which is a symptom common to most glaucoma~     patients. Whatever the cause of low vision, doing day-to-day activities can become~     increasingly difficult, and many suffer from a loss of their independence and may even become~     depressed. Low vision rehabilitation involves helping patients to use their remaining vision~     in optimal, and sometimes even new, ways. This involves an assessment of a person's baseline~     vision, and an idea of what their needs are. Patients are then given low vision aids (such as~     magnifiers, telescopes, video screens which magnify images, and other tools) as well as~     instructions and support for adapting to living and functioning with altered vision.~      Although there currently exists no cure for glaucoma, and we are certainly not promising a~     reversal of the damage done to the eyes from this chronic disease, we do believe that these~     types of rehabilitation services may offer some hope and potential visual benefit to patients~     living with vision loss. Our hypothesis is that the use of state-of-the-art low vision aids~     in patients with advanced glaucomatous visual loss will provide an improvement in visual~     tasks and thereby an improvement in quality of life.~   "
175942|NCT01262196|"~     MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to~     enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a~     pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation~     characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will~     evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic~     acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the~     lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby~     prevent and reduce the duration of organ failure and improve outcome in these patients.~   "
175943|NCT01262183|"~     For esophageal cancer that can not be removed by surgery, the choice of treatment is a~     combination of chemotherapy and radiotherapy. We call this combination- (or concurrent)~     chemoradiotherapy. Chemotherapy is treatment with drugs that kill cancer cells. Both~     chemotherapy and radiotherapy make the tumour smaller and enhance each other's effect. The~     goal of treatment with chemotherapy and radiation therapy is to cure the cancer.~     Unfortunately only a small proportion of patients are cured with this treatment.~      Improvements in the outcome of treatment may be expected by using the so-called targeted~     treatments. With esophageal cancer, a protein (the epidermal growth factor receptor (this is~     a kind of trap), the EGFR), is present in many tumours. This protein causes the tumor to~     grow. Panitumumab is a drug that blocks the functioning of this receptor (catcher), so that~     possibly the growth and spread of esophageal cancer is prevented.~      The main objective of this trial is to see if survival of patients with inoperable esophageal~     cancer improves as panitumumab is added to standard treatment with chemoradiotherapy.~      It will also investigate whether patients tolerate the addition of panitumumab to the~     standard treatment. Also, the biological characteristics of the tumor will be examined. In a~     proportion of patients it will be determined how the enhancement of the cancer is visible on~     an FDG-PET scan before the start of treatment and how this changes during the treatment. It~     will be also be evaluated how this treatment affects the survival.~   "
175944|NCT01262170|"~     A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety~     and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily~     reducing the desire to smoke~   "
175945|NCT01262157|"~     Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of~     new blood vessels. The investigators hypothesized that LISW therapy could improve the~     symptoms of patients with erectile dysfunction resulting from a problem of blood supply that~     do not respond to oral therapy (PDE-5 inhibitors).~   "
175946|NCT01262144|"~     Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease~     is identified are not usually eligible for surgery. PET-CT is used to support staging.~     However, some patients received surgery after staging and subsequently require~     radio/chemotherapy due to findings on operation.~      This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent~     outcomes i.e. need for adjuvant therapy.~   "
175947|NCT01262131|"~     The purpose of this study is to see if a device called the Resonator can help to reduce pain~     and improve aspects of health and quality of life for people with fibromyalgia.~   "
175948|NCT01262118|"~     The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol~     metabolism in patients with active rheumatoid arthritis (RA).~   "
175951|NCT01262079|"~     This is a specimen collection protocol designed with the purpose of understanding the immune~     responses to influenza in children and adult subjects through collection of blood specimens~     and influenza medical history data. This protocol will allow the investigators to evaluate~     influenza-specific immune responses to a variety of influenza strains in a broad age range of~     the U.S. population early and late in the 2010-2011 influenza season. Immune responses will~     be evaluated using blood samples. The underlying hypothesis for this protocol is that the~     detailed characterization of immune responses to influenza in subjects from different age~     groups will further the understanding of immune responses cross-reactivity and advance~     development of influenza vaccines that are cross-reactive against old, new and re-emerging~     influenza strains.~   "
175952|NCT01262066|"~     A number of psychosocial risk factors have been strongly related to a range of health~     problems (chief among them CVD). Clinical research has shown that behavioral interventions~     have enormous promise to ameliorate the psychosocial distress, the health-damaging effects~     and the costs associated with these risk factors. However, few such programs have been~     implemented in a large-scale way. Corporations are increasingly interested in providing such~     services for their employees, but they have encountered difficulties in knowing which~     programs are most effective. Until these programs are developed as products that can be~     tested and shown to produce consistent benefits, dissemination of these beneficial programs~     will be hindered. Taken together, these findings make a strong case that the development of a~     standardized, protocol-driven behavioral intervention package that can be delivered in a wide~     range of corporate settings presents a remarkable commercial opportunity. The overall goal of~     this SBIR Fast-Track-funded project is to gain empirical evidence in a RCT that documents the~     effectiveness of the Williams LifeSkills Workshop (a protocol driven 6-session workshop) in~     reducing BP, psychosocial risk factors, and promoting positive health outcomes in a cost~     effective manner in a corporate setting. This empirical support, tested in a setting~     independent of the program developers and by an experienced research team, will then be used~     to help market the product in the corporate wellness marketplace. It is hypothesized that~     participants (employees in an urban medical center) in the LifeSkills intervention will~     experience greater reductions in blood pressure and improvements in measures of psychosocial~     well-being than those receiving usual medical care and given educational materials on~     reducing BP.~   "
175953|NCT01262053|"~     With the increased adoption of CPOE systems, it is important to recognize that design flaws~     have resulted in the creation of new types of iatrogenic medical errors. An example of a new~     type of iatrogenic medical error introduced by CPOE systems has been named juxtaposition~     errors. Juxtaposition errors, as defined by Ash, et al. are errors that can result when~     something is close to something else on the screen, and the wrong option is too easily~     clicked in error. Juxtaposition errors can lead to a patient receiving a medication, a test,~     or a treatment intended for another patient, sometimes with dire consequences. Juxtaposition~     errors are likely a subclass of a broader group of wrong-patient CPOE errors that have~     multiple etiologies.~      The primary objectives of this research proposal is to investigate the prevalence of~     wrong-patient near miss CPOE errors, to investigate the root cause of these errors, and to~     investigate and compare the efficacy and workflow impact of two distinct interventions to~     prevent these errors.~   "
175954|NCT01262040|"~     The purpose of this study is to determine whether narrowband imaging (NBI) makes it easier~     for a surgeon to see cancer.~      NBI is a kind of light. Normally, white light is used during surgery. White light uses many~     wavelengths of light. NBI only uses two wavelengths which highlight the blood vessels. This~     makes it easier for the surgeon to see blood vessels. Tumors often have more blood vessels~     than normal tissue. As a result, NBI may make it easier for the surgeon to see small tumors.~      In this study the surgeon will look with both normal white light and NBI. This way a~     comparison can be made to determine which is superior.~      Improved identification of tumors allows doctors and patients to make informed decisions~     about whether treatment is needed after surgery. It also provides additional information to~     determine which treatments may be best.~   "
175955|NCT01262027|"~     The goal of this clinical research study is to learn if dovitinib can help to control~     inflammatory breast cancer. The safety of this drug will also be studied.~   "
175956|NCT01262014|"~     Given the low Responses Rates and short survival times achieved with conventional cytotoxic~     agents in resistant ovarian cancer patients, new treatment options are needed in this patient~     population.Antiangiogenic therapy has an important role in this group of patients and~     Pazopanib in particular. We are going to study if Pazopanib is able to control~     disease-related symptoms minimizing the side effects of treatment. This aspect is very~     important in the treatment of resistant ovarian cancer patient since our treatment is~     palliative without any impact in overall survival. So our goal is to study the Clinical~     Benefit Rate (objective responses plus stable disease rates) achieved with Pazopanib and its~     toxicity profile in this subgroup of patients~   "
175957|NCT01262001|"~     To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary~     Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.~   "
175958|NCT01261988|"~     The primary objective of the study is to assess the safety and adhesive performance of the~     VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by~     healthy volunteers.~   "
175959|NCT01261975|"~     The objective of this study is to test the hypothesis that the time to reach a stable~     refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision~     compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision~     Enhancement System.~   "
175978|NCT01261728|"~     The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin~     for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing~     surgery for kidney cancer.~   "
175979|NCT01261715|"~     Two of the more frequently used options for skin closure following a cesarean delivery~     include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin~     adhesive. This method of closure is used less frequently than either staples or sutures.~      Few studies have been done regarding whether Dermabond is preferable or affect the outcome of~     a cesarean section surgery. The aim of our study is to find weather Dermabond haas better~     result for the closure of cesarean section wounds.~   "
175960|NCT01261962|"~     In leukocytes of patients undergoing adjuvant chemotherapy for colon cancer treatment:~     a)identify genes modulated by oral supplementation of zinc; b) evaluate the effects of oral~     zinc supplementation on humoral immunity and neutrophil function. The study will be conducted~     on 30 adult patients aged grater than 18 years, of both genders who have undergone surgical~     resection of colonic neoplastic lesions without metastatic lesion. Patients will be~     randomized into two groups, with the first (Group QT Zn, n = 15) receive 70 mg/d of zinc for~     16 weeks and the second will receive placebo (QT Placebo Group, n = 15). The study will also~     include 30 healthy volunteers who receive supplementation of 70 mg/d of Zn (C Zn group, n =~     15) or placebo (Group C Placebo, n = 15). Zinc supplementation or placebo for all study~     groups will start two days before the volunteers received the pneumococcal vaccine,~     polyvalent 23. Fifteen days after vaccination, patients begin chemotherapy as pre-established~     criteria by the Oncology Service. Will be monitored the parameters of nutritional status~     (anthropometry, bioelectrical impedance, food intake, and laboratory tests) adverse effects,~     according to rules of the CTCAE. In the evaluation of humoral immunity, antibodies~     opsonization and in the pneumococcal polysaccharide will be measured. Will be evaluated the~     function of neutrophils by measuring DNA NETs and quantified calprotectin and elastase~     released in the culture supernatants of activated neutrophils. RT-qPCR will be done of genes~     differentially expressed(DEGS) on activated leukocytes. In six volunteers from each group~     will be analyzed global gene expression from RNA extracted from leukocytes by microarray;~     will be detected and correlated the molecular pathways modulated by zinc by MetaCore software~     (GeneGo). The DEGS will be validated by RT-qPCR.~   "
175961|NCT01261949|"~     Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by~     hearing loss and leading to the phantom auditory perception of sound in the absence of an~     external or internal acoustic stimulus.~   "
175962|NCT01261936|"~     Menorrhagia is the term used to define excessive menstrual blood losses, as often based on a~     subjective judgment of women. Many arbitrary values, expressed in milliliters of blood, have~     been proposed to define this symptom: 60 on each cycle has also been confirmed in our~     preliminary study on 87 healthy women. The quantitative determination of menstrual blood~     losses is nevertheless rarely performed, only in research settings. Although menorrhagia is a~     quite frequent symptom in healthy women apparently haemostatically competent in the fertile~     age (20-30%), its incidence becomes very high in women affected by congenital coagulation~     factors deficiency and (50-62.9%) inherited platelet defects, e.g. Glanzmann's~     Thromboasthenia (GT); also in von Willebrand Disease the bleeding symptom menorrhagia has~     an high prevalence (60-75%)(8); for GT an incidence of 90% has been reported.~      This explains the need for a study focused on the evaluation of menorrhagia in CBDs,~     addressed to answer to the following, still unsolved questions:~        1. Definition of the entity of menstrual blood losses in women affected by CBDs~        2. Elaboration of specific treatment schedules for each type of CBD~        3. Impact of different specific treatment schedules on kinetic and entity of menstrual~          losses (how does treatment modify losses?).~   "
175963|NCT01261923|"~     This study aims to investigate whether liver patients may tolerate alitretinoin by comparing~     metabolism in 8 such patients with the metabolism in 8 healthy controls~   "
175964|NCT01261910|"~     The primary purpose of this study is to test different methods by which kidney transplant~     centers can educate potential transplant candidates about living donor kidney transplant~     (LDKT).~      The most effective ways to educate kidney transplant candidates about LDKT remain unclear.~     The goal is to determine, among a diverse cohort of potential kidney transplant candidates,~     whether a transplant center-based intervention will increase understanding of the~     opportunities for and process, risks, and benefits of living kidney donation and LDKT. The~     investigators hypothesize that kidney transplant candidates' understanding of living kidney~     donation and LDKT will be increased by interventions implemented at the transplant center on~     the day of transplant evaluation.~      The investigators propose a single-center, 2-arm, cluster-randomized, controlled trial to~     compare the effects of two educational strategies upon transplant candidates' understanding~     of living kidney donation and LDKT:~        1. Usual transplant education implemented by the transplant center, on the day of the~          transplant evaluation (standard care); and~        2. Intensive initial transplant education implemented on the day of the transplant~          evaluation.~      Intensive initial transplant education will utilize videos of living donors' experiences as~     well as a session with a trained Transplant Educator, who will focus upon living donation~     education. One week after the transplant evaluation day and 3 months later, the investigators~     will assess transplant candidates' knowledge of LDKT (using questionnaires), identify~     correlates of increased understanding of LDKT, and assess racial/ethnic differences in the~     understanding of LDKT.~   "
175965|NCT01261897|"~     The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and~     morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor~     -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total~     knee arthroplasty.~   "
175966|NCT01261884|"~     Preeclampsia and other high blood pressure disorders of pregnancy are a significant cause of~     both maternal and fetal complications of pregnancy. To date, there is no known cure for~     preeclampsia, but studies have shown that exercise may lower the risk of preeclampsia and~     high blood pressure disorders in pregnancy. Resistance training also lowers blood pressure,~     and may be easier to perform in a pregnant population, leading to higher compliance. The~     investigators propose to perform a novel prospective study of a resistance training regimen~     on blood pressure in pregnant patients at high risk for developing preeclampsia or high blood~     pressure.~   "
175967|NCT01261871|"~     The purpose of this study is to measure pressures within the eye (during surgery to remove~     the prostate or abdominopelvic masses) as the body position required for these laparoscopic~     procedures has been associated with increases in pressure within the eye.~   "
175987|NCT01261611|"~     The purpose of this study is to evaluate how well a new drug called Dysport RU works and how~     safe it is, when it is used for the treatment of cervical dystonia. Dysport RU will be~     compared to an approved drug called Dysport.~   "
176035|NCT01260987|"~     Nodular Basal Cell Carcinomas:~      Compare the efficacy and safety of conventional versus fractional laser assisted PDT for~     difficult to treat nodular cell carcinomas in the face.~      Actinic keratosis:~      Compare the efficacy and safety of conventional versus fractional laser assisted PDT for~     moderate to severe actinic keratoses located in the face and on the hands.~   "
175968|NCT01261858|"~     Median sternotomy has been the standard incision for coronary artery bypass grafting (CABG)~     in patients undergoing surgery for coronary artery disease. Given the increasing risk profile~     of contemporary cardiac surgery patients, sternal complications are subject to increase~     concomitantly. Despite advances in many areas of cardiac surgical procedures, innovation in~     sternal closure technique has been lacking and postoperative complications remain. In this~     study, the investigators aim to assess the effectiveness of using a novel osteoconductive~     biologic bone cement (KryptoniteTM, Doctors Research Group Inc.) as an adjunct to~     conventional sternal closure in post CABG patients having median sternotomy.~      The outcomes of interest for this study will include: pain, discomfort, lung function, wound~     healing and analgesic use. The investigators assume that the use of KryptoniteTM will~     decrease postoperative pain leading to improvement in postoperative lung function. This may~     also lead to improvement in patient recovery and decrease in postoperative complications.~      The investigators will undertake a single-blinded randomized, controlled study consisting of~     patients undergoing elective coronary artery bypass grafting (CABG) randomly assigned to~     either Group A (usual closure with stainless steel wires) or Group B (usual closure with~     stainless steel wires plus application of bone cement). Each group will consist of 64~     patients in a total of 128 patients. Lung function data using a spirometer will be collected~     preoperatively and 3rd and 5th postoperative days as well as in outpatient clinic. Pain data~     will be collected on the 1st to 5th postoperative days.~   "
175969|NCT01261845|"~     BACKGROUND: A proper understanding of the attitudes towards its own health status and concise~     estimates concerning the health seeking behavior of the different subgroups of a population~     are highly desirable. The structure of the Austrian population with regard to its age~     distribution and the proportion of people with immigrant backgrounds have been rapidly~     changing in recent years. Questions of allocating limited resources and meeting the needs of~     under-served populations have become increasingly important. However, data that could~     illuminate these issues are sparse and therefore obtaining them will be important for making~     sensible policy decisions.~      METHODS: A telephone survey of the Austrian population for the assessment of the occurrence~     of any health complaint and the subsequent help seeking behavior with special emphasize on~     under-served minority groups - migrant population, elder people, and female gender.~      AIMS: Our analysis of the data obtained should help to clarify some hitherto undocumented~     aspects and should provide the evidence for building a better health care infrastructure with~     equality of access and efficient coordination. We also hope that this information can help to~     allocate resources strategically according to needs and cost-efficiency in health care.~   "
175970|NCT01261832|"~     Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet~     therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin~     and clopidogrel is the important cause of poor clinical prognosis. Therefore, recently,~     clinical research about the triple antiplatelet therapy including cilostazol is actively~     conducted. But, clinical research about triple antiplatelet therapy for acute myocardial~     infarction is inadequate situation, and the ideal duration of triple antiplatelet therapy has~     been actively discussed. Therefore, we try to evaluate the clinical outcomes of triple~     antiplatelet therapy in acute myocardial infarction patients undergoing percutaneous~     intervention with drug eluting stent compared with dual antiplatelet therapy and investigate~     ideal duration of triple antiplatelet therapy through this research.~   "
175971|NCT01261819|"~     The study aimed to compare the use of a transurethral laparoscope to the use of a traditional~     cystoscope for evaluation of the bladder and ureters at the time of laparoscopic~     hysterectomy. The hypothesis was that visual inspection of the bladder and ureters can be~     done safely using a transurethral laparoscope, takes less time than traditional cystoscopy,~     and is more cost effective than traditional cystoscopy.~   "
175972|NCT01261806|"~     Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior~     and biology, and are at risk for a host of mental health problems. Critical issues for~     toddlers straddle the challenges of infancy and preschool years. In particular, toddlers in~     foster care face significant challenges in forming new attachment relationships and~     developing behavioral and biological regulatory capabilities. This project will assess the~     effectiveness of an intervention that targets these issues. Attachment and Biobehavioral~     Catch-up for Toddlers in Foster Care (ABC-T) was developed to help parents: provide nurturing~     care so that children develop secure, trusting relationships; and supporting children when~     they become overwhelmed that enhance children's ability to regulate behavior and biology.~     This intervention's effectiveness will be assessed in a randomized clinical trial.~   "
175973|NCT01261793|"~     The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the~     treatment of subjects with Systemic Lupus Erythematosus (SLE).~   "
175974|NCT01261780|"~     Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer~     therapy with few treatment options. CIPN is a complex side effect that varies between~     individuals and can be difficult to describe, difficult to treat and can significantly effect~     quality of life for patients.~      The purpose of this study is to determine if patients with painful CIPN will have a decrease~     in pain scores after treatment with the MC-5A device.~   "
175975|NCT01261767|"~     This trial is conducted in the United States of America (USA). The aim of this clinical trial~     is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to~     determine the preliminary efficacy in an expansion phase of this trial.~      This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a~     multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks.~      Initiation of the MD expansion phase will depend on results from the SD and MD~     dose-escalation phases and only if an acceptable safety profile is present. Subjects~     participating in the expansion phase are not allowed to have participated in the previous~     phases (SD and MD dose-escalation phases) of the trial.~   "
175976|NCT01261754|"~     This is a single-blind, randomized, cross-over design. Patients with metastatic prostate~     adenocarcinoma; newly diagnosed, high-risk patients with prostate adenocarcinoma; and healthy~     subjects will be administered a single intravenous dose of each of the study drugs 99mTc MIP~     1404 and 99mTc MIP 1405 administered approximately 14 to 21 days apart.~   "
175977|NCT01261741|"~     In this study, memantine will be tested in a new indication: in the treatment of subjective~     memory, concentration, or attention problems (subjective cognitive impairment) in the absence~     of dementia.~   "
175980|NCT01261702|"~     All patients were premedicated with oral midazolam 5-15 mg. one hour before surgery. General~     anesthesia with double lumen endobronchial tube was given. Patient was induced by propofol~     and fentanyl. Cisatracurium was given to facilitate intubation. Patient was ventilated with~     50% oxygen in air. Anesthesia was maintained with propofol and fentanyl in order to keep~     blood pressure and heart rate within 20% of the baseline. Cisatracurium was given every 30~     minutes in order to control ventilation. At the end of surgery, neuromuscular blockade was~     reversed.In PACU, the I.V. PCA machine was connected to the patient. The setting of PCA was~     basal infusion of morphine 1 mg/hr bolus of morphine 1 mg with lockout interval 5 minutes and~     4-hour limit 30 mg.The patient's mean arterial blood pressure, heart rate were recorded~     before induction, before intubation, at 15, 15, 30, 60, 90 and 120 minutes after intubation,~     and at 4, 8,16 and 24 h after surgery. The total amounts of fentanyl, propofol and magnesium~     sulphate were recorded. The time between the cessation of magnesium sulphate and extubation~     was recorded. The amounts of morphine usage at 4, 8, 16 and 24 hours after surgery were~     recorded. Pain score was evaluated at rest and deep breath and sedation score at 1, 2, 3, 4,~     8, 16 and 24 hours after surgery using numeric rating scale (NRS). Sedation score was graded~     as 0 = fully awake, 1 = somnolence, responds to call, 2 = somnolence, responds to tactile~     stimulation, 3 = asleep, responds to painful stimulation. The times that the patient first~     sipping, taking food, sitting at the edge of bed and walk with help were also recorded. The~     side effects such as nausea, vomiting, pruritus and respiratory depression were recorded.~     Cost effective analysis was also evaluated.~   "
175981|NCT01261689|"~     * The objective of the study: to assess the impact of a proactive policy of offering EA at~     the start of labour as compared to a restrictive policy or care as usual.~      * Study design: It concerns a multicentre randomised open label trial.~      * Study population: Term nulliparous and multiparous women with a child in cephalic~     presentation, and without contraindications for vaginal labour or EA.~      * Intervention: Women will be allocated to the EA group or the care-as-usual group. In the EA~     group, women are given an EA as soon as they are in labour. In the care-as-usual~     (restrictive) group, women receive pain relief only on their explicit request.~   "
175982|NCT01261676|"~     Caesarean (CS) delivery rates in the Netherlands increased from 5 to 15% the last 20 years.~     CSs have no clear benefit for overall neonatal outcome and are associated with higher~     maternal complications and high costs. Dutch guidelines offer clear recommendations on~     factors that have a direct effect on the decision to perform a CS.~      Hypothesis: there is incomplete adherence to the recommendations from the guidelines on CS~     among Dutch gynaecologists.~      This study consists of four phases:~        1. Development of quality indicators: A set of quality indicators regarding the process,~          structure and outcome of care will be developed according to the RAND-modified Delphi~          method. A representative, national expert panel consisting of 12 to 15 obstetricians and~          midwives will participate.~        2. Current care study: The current Dutch care will be studied in 20 hospitals (N=80~          gynaecologists). 1000 files on performed CSs are analyzed regarding the adherence to the~          developed quality indicators. To get insight into Dutch practices compared to~          international data, basic obstetrical data will be extracted from the delivery database.~        3. Barrier analysis: A barrier analysis will be carried out based on the results of the~          current care study. Two groups of hospitals will be identified in the upper and lower~          extremes of the 'adherence distribution': 5 hospitals with the lowest and 5 hospitals~          with the highest adherence scores. Factors that determine the decision to perform a CS~          or not (barriers and facilitators) will be analyzed in both groups using semi-structured~          interviews among 15-20 professionals and 15-20 patients. A questionnaire will be used to~          study the 'prevalence' of these factors among all obstetric gynaecologists in the~          Netherlands and among 200 patients.~        4. Controlled before- and-after (CBA) study: Based on the outcomes of the current care~          study and the barrier analysis, a tailor made implementation strategy will be developed~          in order to increase adherence to the CS quality indicators. Target groups will be~          selected with focus on women with both a high incidence of the indicator and low~          indicator adherence. The strategy will be executed and evaluated in a CBA-study in 12~          hospitals (6 intervention, 6 control) in terms of effectiveness, experiences and costs.~          The sample size will be dependent on the target group and adherence to the quality~          indicators regarding this target group. These data will be available after performing~          the current care and the barrier study.~   "
175983|NCT01261663|"~     Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The~     consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting~     against malnutrition. Their use is easy, and framed by recent French recommendations~     suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no~     scientific data to affirm which is the best of these two hypothesis in elderly hospitalised~     in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in~     Limoges university hospital showed some problems about the mode of supplying NOS, partially~     linked with an insufficiency for paramedical staff in realizing importance of NOS. However,~     the effect of time of supplying NOS on total food consumption had not been evaluated in this~     first study. The new one will include 48 malnourished elderly patients in two LTCU and having~     a prescription of NOS. They will receive them at the same quantity during the whole study~     either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely.~     Order of choice will be randomised. Total daily alimentary intakes will be noted by~     paramedical staff of the two units, and translated by dieticians in daily energy, protein,~     carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these~     intakes, in order to precise the best one.~   "
175984|NCT01261650|"~     Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic~     widespread pain present at a similar level for at least 3 months. The aim of this study is to~     examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce~     chronic pain.~   "
175985|NCT01261637|"~     This study has been designed to determine if women undergoing cesarean delivery with spinal~     anesthesia and routine pain management who also have an additional ultrasound guided~     transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better~     quality of recovery than women who don't have the additional TAP block. Maximizing pain~     relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and~     acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially~     reduce chronic pain.~   "
175986|NCT01261624|"~     The present study has been designed in order to evaluate the efficacy and safety of two doses~     of Givinostat in subjects with polyarticular course JIA~      Givinostat ready-to-use suspension especially intended for paediatric administration, will be~     administered orally at different daily doses.~      Patients with an established diagnosis of one of the following JIA forms (Polyarticular JIA~     rheumatoid factor positive or negative, Oligoarticular extended JIA, Systemic JIA without~     active systemic features) will be enrolled.~      The treatment regimen will remain unchanged for 12 weeks and the clinical response will by~     assessed by applying the ACR Pediatric response criteria. Patients achieving at least an ACR~     Pediatric 30 response will continue receiving the assigned dose for 12 further weeks.~      After the end of study (week 24) responder patients will be allowed to extend the treatment~     until they maintain a clinical benefit.~   "
175988|NCT01261598|"~     The poor prognosis in the early-stage of lung cancer is due to potential worsening of the~     disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual~     treatments.~      FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose~     consumption. Then, this exam is used for pathology staging, target volume definition for RT,~     and treatment efficiency few months after RT or CRT. Our assumption is that an FDG-PET exam~     during the course of the RT or CRT might be predictive of the treatment efficiency few months~     later.~      In this study, the investigators propose to perform 4 FDG-PET: first PET1 before~     radiotherapy, second PET2 during the radiotherapy (see RTEP1), third and fourth PET3~     PET4 3month and 12 month after the therapy.~      The investigators will investigate the performances of FDG-PET performed during the RT or CRT~     for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is~     confirmed, the investigators would be able to optimize the planning treatment during the~     course of the therapy.~   "
175989|NCT01261585|"~     Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG),~     fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT)~     measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before and~     in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive~     bronchial cancer.~      This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and~     the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive~     bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not~     small cell lung.~      The investigators are also going to study several scenarii of optimization of the~     radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the~     cellular proliferation measured in the course of radiotherapy (theoretical study on console~     using the scanner and the various examinations).~   "
175990|NCT01261572|"~     To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in~     patients with prostate cancer.~   "
175991|NCT01261559|"~     The primary hypothesis of this study is that breast displacement out of the direct plane of~     imaging during computed tomography (CT) of the abdomen will reduce effective radiation dose~     to the female breast. Secondary hypotheses are that image noise and artifacts will also be~     decreased.~   "
175992|NCT01261546|"~     STUDY JUSTIFICATION~        1. Scientific evidence of the usefulness of corticosteroid use for infectious diseases:~          Corticosteroids along with antibiotic use improve survival in some infectious processes~          provide long term benefits and improve symptoms in many others.~        2. Clinical Observation: the investigators observed that patients with parapneumonic~          pleural effusion and associated bronchospasm who were treated with corticosteroids for~          their bronchospasm, evolved to healing before patients who were not treated with~          corticosteroids (average admission days 10 vs. 17).~        3. Rationale: the anti-inflammatory effect has been the rationale for the use of~          dexamethasone as an inhibitor of the inflammatory response observed after the first dose~          of parenteral antibiotic in bacterial meningitis. A similar effect is likely to occur in~          pneumonia with pleural effusion. It can be therefore hypothesized that Dexamethasone~          could inhibit an excessive inflammatory response by mesothelial and inflammatory cells~          during the early phases of parapneumonic empyema, reducing its severity and hence its~          complications.~      OBJECTIVES~        1. Principal: to investigate if dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic~          therapy reduces time to resolution of parapneumonic pleural effusion.~        2. Secondary:~      2.1. Evaluate the effect of dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic~     therapy on the development of complications during pleural effusion episode.~      2.2. Evaluate the incidence of severe and non severe adverse events associated with the new~     treatment versus standard therapy.~      METHODS~        1. Study design: exploratory (pilot), randomized, double blinded, placebo controlled,~          parallel stratified design, multicentric.~        2. Participating Hospitals (n=56, 7 patients per center):~             -  Hospital Infanta Sofía (S. Sebastián de los Reyes, Madrid).~             -  Hospital Universitario de Getafe~             -  Hospital Universitario Ramón y Cajal, Madrid.~             -  Hospital Universitario Materno-Infantil Carlos Haya, Málaga.~             -  Hospital Infantil La Paz, Madrid.~             -  Hospital U. Gregorio Marañón~             -  Hospital U. Príncipe de Asturias~             -  Hospital Virgen de la Salud, Toledo~        3. Endpoints:~           3.1. Primary: time to resolution. 3.2. Secondary endpoints:~             1. Effectiveness: number of children with complications.~             2. Safety (expected number: none). i) Hyperglycemia ii) Signs of gastrointestinal~               bleeding iii) Need of transfusion iv) Oropharyngeal Candidiasis v) Allergic~               reaction vi) Other adverse reactions described in the Medication Guide.~        4. Treatment arms:~      3.1. Control (0)~        -  Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days.~        -  Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present.~        -  Ranitidine 5 mg/kg IV, q.d. for 2 days.~        -  Amoxicillin- Clavulanic acid 80mg/kg p.o., q.d. during 15 days.~      3.2. Study treatment: (1)~        -  dexamethasone 0,25mg/kg, IV, q.i.d. for 2 days.~        -  Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present~        -  Ranitidine 5 mg/kg IV, q.d. for 2 days~        -  Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days.~           4. INCLUSION CRITERIA~        -  Patients between 1 and 14 year old.~        -  Presence of pneumonia diagnosed by clinical and radiographic criteria: cough, fever and~          radiological consolidation.~        -  Evidence of pleural effusion.~   "
175993|NCT01261533|"~     The purpose of this study is to determine the feasibility, primary safety and efficacy of~     foldable capsular vitreous body (FCVB) in the treatment of retinal detachment, based on the~     multi-center clinical trial.~   "
175994|NCT01261520|"~     This study examined whether a culturally-tailored video has a greater impact on increasing~     mammography use in Chinese American women and improving barriers to mammography screening~     compared to a generic, non-tailored video and a printed fact sheet (control group).~   "
175995|NCT01261507|"~     A new software product takes two chest radiographs, aligns them, and then subtracts one image~     from the other. The resulting image represents an image showing any differences between them.~     The study is to determine whether radiologists using this new software perform better with it~     than when they do not use it.~   "
175996|NCT01261494|"~     This study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with~     GFT505 (80 mg/d) on Glycosylated Haemoglobin A1c (HbA1C) and fasting plasma glucose.~      And to assess the tolerability and safety of once-a-day administrations of oral doses of~     GFT505 for 12 weeks in patients with type 2 diabetes mellitus.~   "
175997|NCT01261481|"~     The purpose of the study is to compare the relative bioavailability and pharmacokinetics of~     tolvaptan 15 mg tablets administered orally versus tolvaptan via nasogastric (NG) tube in~     healthy male and female subjects.~      This study is an open 2-treatment, 2-period, 2-sequence crossover study to compare the~     relative bioavailability of tolvaptan tablets to tolvaptan given via nasogastric tube in 28~     healthy adults. Subjects will be randomized to one of the two treatment sequences; either~     tolvaptan oral tablets swallowed intact followed by a tablet crushed and administered via~     nasogastric tube, or the reverse sequence. Serial pharmacokinetic samples will be collected~     following each tolvaptan administration and safety assessments will be performed. The~     relative bioavailability of tolvaptan administered via nasogastric tube will be compared to~     tolvaptan tablets swallowed intact.~   "
175998|NCT01261468|"~     The primary purpose is to study the effect of spinal cord stimulation (SCS) on sensory~     parameters, using quantitative sensory testing (QST).~      Patients with established SCS treatment will be examined with QST. Subjects will be~     randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period,~     then be reexamined using the same QST protocol.~      After the 2nd examination all patients cross over (ie. inactive devices are activated, active~     devices are deactivated) and are reexamined after a new 12-hour period.~      The investigators expect to demonstrate that SCS treatment has a significant effect on~     sensory parameters associated with pain hypersensitivity but no significant effect on sensory~     parameters associated with detection of non-painful stimuli.~   "
175999|NCT01261455|"~     The purpose of this study is to determine if there is any difference in the surgical time~     when the surgery is performed with a graft taken from under the upper lid versus lower lid.~     The investigators will also be recording the level of pain felt by patients after surgery,~     any difficulties during or after surgery, and if the pterygium grows back.~   "
176000|NCT01261442|"~     The cross sectional area of posterior tibial nerve (PTN) is increased in diabetic patients~     with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN.~     This study aims to evaluate whether the cross sectional area of the Posterior Tibial Nerve~     (PTN) as measured by ultrasound is increased in patients with distal symmetric polyneuropathy~     (DSPN) as compared to diabetic patients without DSPN.~   "
176001|NCT01261429|"~     The purpose of this study is to explore the efficacy of nilotinib as a treatment of patients~     with progressive or relapsing pigmented villo-nodular synovitis / tenosynovial giant cell~     tumour (PVNS/TGCT) who cannot be treated by surgery.~      The primary objective of the study will be to determine the efficacy of 12 weeks (3 months)~     of nilotinib treatment as measured by the non progression rate (Complete response + Partial~     Response + Stable disease according to Response Evaluation Criteria In Solid Tumours - RECIST~     version 1.1) in patients with progressive or relapsing PVNS/TGCT who cannot be treated by~     surgery.~      this study is an international, multicentre, non-randomized, open-label phase II clinical~     trial with a Bayesian design.~      A maximum sample size of 50 patients will be included in the study~   "
176003|NCT01261403|"~     The primary objective of the study is to assess the safety and efficacy of 2 dose groups~     (PDA001 versus vehicle control) in subjects with active rheumatoid Arthritis. The secondary~     objectives of the study are to determine the clinical response at defined visit intervals,~     determine the time to flare of RA symptoms and to quantify changes in inflammatory markers~     including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A~     (SAA), and IL-6.~   "
176004|NCT01261390|"~     Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a~     common health problem that is often associated with loud snoring and sleepiness.The medical~     term for this problem is obstructive sleep apnea (OSA). People with OSA often have an~     increased risk for developing heart disease or may already have a diagnosis of heart disease.~      A clinical research study is being conducted at Brigham and Women's Hospital (BWH) and Beth~     Israel Deaconess Medical Center (BIDMC) to compare the effects of continuous positive airway~     pressure (CPAP) to conservative medical therapy with participation in one of four groups:~        1. Active-PAP Therapy Group (Active-Beh or Active+Beh): Will receive standard medical~          treatment for sleep apnea with active-PAP. Participants will be randomized to either:~             1. Active-Pap with respiratory therapist visits only~             2. Active-Pap with respiratory therapist visits and cognitive behavioral therapist~               visits.~        2. Alternative PAP Group (Sham): Will receive lower air delivery level than active-PAP~          therapy group. Will also have meetings with respiratory therapist.~        3. Conservative Medical Therapy Group (CMT)*: Will receive a free supply of nasal strips~          for the duration of their treatment period (either 6 months or 12 months) and follow~          healthy sleep hygiene guidelines for how to change sleep habits to minimize incidences~          of apneas (breathing disturbances during sleep). Frequent follow-up support with~          research coordinator.~      A sleep doctor or cardiologist will have indicated that a potential participant is an~     appropriate candidate to receive PAP or CMT as acceptable approaches to treat his/her sleep~     apnea. Participants will be recruited between the ages of 45-75 years who have diagnosed~     heart disease or between 55-75 years for those who have risk factors for developing heart~     disease.~      This is a 6-12 month study** to evaluate alternative ways to address the potential for OSA~     treatment to reduce heart disease and to identify those features that would strengthen a~     later, large-scale randomized controlled trial.~      We will test the hypothesis that active treatment for OSA with CPAP reduces CVD morbidity and~     mortality.~      *All randomized participants will be given conservative medical therapy (CMT).~      **For those randomized after December 31, 2012, follow-up assessment will only be 6 months~     long~   "
176005|NCT01261377|"~     Patients with both sleep apnea and COPD have overlap syndrome, but their optimal management~     is not known. We plan to conduct a randomized trial of of bi-level PAP vs. night time oxygen~     to asses the impact of intervention on cardiac MRI and biomarkers.~   "
176006|NCT01261364|"~     Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive~     report improves outcomes when compared with standard treatment without the availability of~     genetic information.~   "
176007|NCT01261351|"~     The primary purpose of the trial is to evaluate coagulation activator markers in patients~     with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with~     the severity of the pathology.~   "
176008|NCT01261338|"~     Because of industrial pollution, a large number of people in Annison, Alabama, have elevated~     body burdens of the class of compounds known as polychlorinated biphenyls (PCBs). There is~     evidence that these compounds are associated with risks to health including diabetes. There~     is also evidence that the consumption of a non-absorbable dietary fat can reduce the level of~     compounds like PCBs. This clinical trial will test the hypothesis that a non-absorbable~     dietary fat can reduce the levels of PCBs in subjects in Anniston.~   "
176009|NCT01261325|"~     This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and~     200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with~     partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant~     antiepileptic drugs.~   "
176010|NCT01261312|"~     Phase 1-2 dose escalation randomized study in patients with intermediate or high risk~     myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML). The Dose Escalation~     Segment will evaluate the biological activity, preliminary safety and efficacy of SGI-110~     with two dosing schedules in MDS and AML patients while the Dose Expansion Segment will~     further evaluate safety and efficacy at the biological effective dose (BED) or maximum~     tolerated dose (MTD)as defined in the Dose Escalation Segment.~   "
176011|NCT01261299|"~     Carboplatin kills cancer cells mainly through induction of DNA damage (drug-DNA adducts). The~     goal of this clinical trial is to determine if chemoresistance to carboplatin can be~     identified by measuring carboplatin-induced DNA monoadducts, the precursor of Pt-DNA~     diadducts or crosslinks, from subtherapeutic drug doses given prior to the initiation of~     chemotherapy. We hypothesize that low levels of carboplatin-DNA monoadducts and rapid~     drug-DNA adduct repair correlate with chemoresistance. A highly sensitive technology, called~     accelerator mass spectrometry (AMS), will be used to measure carboplatin-DNA monoadducts from~     patient samples. AMS can measure C-14 at the attomole level in specimens of milligram size.~     In this study, patients will receive one non-toxic microdose (defined as 1/100th the~     therapeutic dose) of C-14-labeled carboplatin. Blood specimens will be drawn for~     determination of carboplatin-DNA monoadduct formation and repair in peripheral blood~     mononuclear cells (PBMC), and pharmacokinetics (PK) will be determined from serum~     ultrafiltrate. In patients microdosed prior to providing tumor samples, a few milligrams of~     leftover tumor biopsy/resection specimens will be analyzed for formation of carboplatin-DNA~     monoadducts. Patients will subsequently receive carboplatin-based chemotherapy. The levels of~     microdose-induced carboplatin-DNA monoadducts will be correlated with response to~     chemotherapy. Some blood and biopsy samples will be assayed by RT-PCR for several putative~     resistance markers at the mRNA level. Side effects will also be monitored and compared to the~     AMS data. This trial will also utilize PK, DNA repair and pharmacogenomics data in order to~     determine some of the underlying chemoresistance mechanisms.~   "
176012|NCT01261286|"~     Objective: To determine the effect of C-reactive protein (CRP) status, and infliximab~     treatment on the pharmacodynamics and pharmacokinetics of verapamil, a model drug for L-type~     calcium channel blocking, in Crohn's disease (CD) patients compared to healthy patients.~      Hypotheses:CD patients will have elevated plasma verapamil concentrations, but diminished~     dromotropic response to verapamil; the concentration of circulating norepinephrine, used as a~     surrogate marker of sympathetic nervous activity, will be similar between the healthy~     patients and the CD patients; the sympathetic nervous system of the heart will be similar to~     healthy patients; Crohn's disease patients with normal CRP will have higher drug response~     compared to high CRP (>3 mg/l) patients; and that infliximab-treated patients will have~     higher verapamil response than those with similar symptom profiles who are not infliximab~     treated.~   "
176090|NCT01260272|"~     This trial compared the effects of raisin intake on cardiovascular risk factors compared to~     common, commercially available, alternative snacks. These cardiovascular risk factors include~     glucose, blood pressure, lipid levels, body weight, and waist circumference.~   "
176013|NCT01261273|"~     Title Prospective, single-arm, multi-centre, observational registry to further validate~     safety and efficacy of the Nobori® DES in real-world patients.~      Objective Primary objective The primary objective of e-NOBORI registry is to further validate~     the safety and efficacy of Nobori® DES system in unselected patients representing everyday~     clinical practice.~      Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac~     death, target vessel related myocardial infarction (MI) and clinically driven target lesion~     revascularization (TLR) at 1 year~   "
176014|NCT01261260|"~     On the dual basis of findings indicating GABA increases following acute and eight week~     SSRI/dopamine agonist administration and those indicating GABA-ergic effects following 14 day~     pyrimidine administration, the purpose of this study is to assess our following hypotheses:~        1. Relative to placebo, an oral dose of 1g of uridine BID for seven days will increase~          brain GABA levels in a sample of healthy, unmedicated adult males;~        2. Relative to placebo, an oral dose of 1g of uridine BID for seven days will increase NTP~          levels in a sample of healthy, unmedicated adult males; and~        3. Brain GABA levels will be directly correlated to high energy phosphate levels in this~          sample of healthy, unmedicated adult males.~   "
176015|NCT01261247|"~     Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. This phase II trial is studying how well panobinostat works in treating patients~     with relapsed or refractory non-Hodgkin lymphoma~   "
176016|NCT01261234|"~     CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to~     that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting~     (CAS) in patients scheduled to undergo CAS. Study design is Multicenter Prospective~     Ranodomized Controlled Study, rondomized by cilostazol/non-cilostazol group prior to CAS. 900~     patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after~     CAS, evaluated by carotid ultrasound and angiography.~   "
176017|NCT01261221|"~     Kaohsiung Medical University Chung-Ho Memorial Hospital will provide a long-term free medical~     service in Indian Tibetans since July 2010. The investigators plan to investigate metabolic~     syndromes and HIV infection in Indian Tibetan community. The investigators will survey the~     prevalence and risk factors by means of HIV quick test and questionnaires. Since there is~     lacking of prevalence survey for metabolic syndrome and HIV infection in Tibetan colony of~     India, the investigiators will carry out this survey under the support and assistance of~     Department of Health of Central Tibetan Government.~   "
176018|NCT01261208|"~     The purpose of the Study is to investigate the prevalence of Helicobacter Pylori infection~     among the HIV/AIDS group. The study will screen the patients who were confirmed HIV/AIDS in~     Kaohsiung Medical University Hospital and collect the cases who were suspicious of~     Helicobacter Pylori infection.~   "
176019|NCT01261195|"~     HUVEC primary cells for researches about the relation between plasma leakage and infections.~   "
176020|NCT01261182|"~     School feeding programs provide students meals conditional on school attendance, which can~     have impacts on school participation, cognition and learning, and nutritional outcomes.~     Although the literature on impacts of school feeding programs is substantial, high quality~     studies with evaluation designs that provide causal impact estimates are relatively few. Thus~     program impacts on educational, cognitive and nutritional outcomes are not well-understood,~     particularly in a field setting. Nutritional impacts in particular are questionable, which~     may be a result program design. Most studies provide only small transfers to children and~     examine average macro-nutrient effects of the transfer on the treated children, thus it is~     not surprising that detection of nutritional gains has been minimal.~      This study is a cluster-randomized evaluation of a school feeding program administered by the~     World Food Programme in the Northern Ugandan Districts of Lira and Pader. The program~     provides substantially larger food rations than most programs (representing 1/3 of children's~     daily caloric needs and 99% of iron intake requirements).~      The key research objectives are:~        1. Impact on the treated: Assess the effectiveness of the program at improving nutritional~          status, education and cognitive and learning outcomes for school-age children, with~          particular attention to the anemia status of older school-age girls .~        2. Impact on untreated but nutritionally vulnerable sub-groups: Assess the effectiveness of~          the program at reducing anemia prevalence in mothers and younger siblings.~        3. Optimal program design: Assess the differential impacts of a program in which children~          are fed at school compared with one in which they are given dry rations to bring home.~   "
176021|NCT01261169|"~     This study is designed to explore the use of Myfortic® in patients with steroid-refractory~     uveitis. The aim of the study will be to show the therapeutic effect of Myfortic® in managing~     uveitis patients.~   "
176022|NCT01261156|"~     The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics~     (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.~   "
176023|NCT01261143|"~     The purpose of this study is to determine the:~      Primary end point~        -  change of Total symptom score~      Secondary end point~        -  neurological test~   "
176024|NCT01261130|"~     This two part study will evaluate the safety and immunogenicity of two formulations of~     Na-GST-1, first in hookworm-naïve individuals using an open-label design, and then in adults~     living in an area of endemic hookworm infection using a randomized, double-blind design. The~     two formulations to be evaluated are Na-GST-1 adsorbed to an adjuvant, Alhydrogel®, and~     Na-GST-1 adsorbed to Alhydrogel® and administered with GLA-AF.~   "
176025|NCT01261117|"~     To determine whether oral or intravenous ibuprofen has a better or same efficacy and~     tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm~     infants.~   "
176034|NCT01261000|"~     Acromegaly is a disease of the pituitary gland that involves overproduction of growth~     hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout~     the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I~     levels in the blood. However, no studies have evaluated the effects of blocking GH receptors~     in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and~     IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with~     pegvisomant.~   "
176179|NCT01259102|"~     The purpose of this study is to determine the pharmacokinetics of BTDS following same-site~     patch reapplication after rest intervals.~   "
176026|NCT01261104|"~     Purpose: to investigate the relationship between time for treatment seeking and audiometric~     data and self-assessment of handicap for patients in a public hearing healthcare service.~     Methods: Retrospective study. Records of 152 elderly and 48 adults with hearing impairment~     were analyzed. The ISO audiometric thresholds average (500 to 4000Hz) and high frequencies~     average (2000 to 6000Hz), the speech recognition thresholds and the total, social and~     emotional scores from the Hearing Handicap Inventory for the Adults (HHIA) and Elderly (HHIE)~     were compared with the time between the onset of hearing complaints and the first treatment~     seeking. Results: The average time for treatment seeking was 7,6 years. No statistical~     difference was found between ISO and high frequency audiometric average, HHIA/E scores and~     time for treatment seeking between adults and the elderly. Weak but significant negative~     correlations were observed between the audiometric data and time for treatment seeking. There~     was no relationship between the time for treatment seeking and educational, socioeconomic~     levels and perception of handicap. Conclusions: The search for treatment seems to be~     multifactorial. Despite technological advances and changes in access to information and~     treatment time for treatment seeking was similar to that reported 30 years ago.~   "
176027|NCT01261091|"~     Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation,~     have a particularly bad prognosis. If they require long-term ventilation, their orotracheal~     tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal~     tube below the larynx. This so called tracheostomy might be associated with advantages such~     as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth~     hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for~     tracheostomy in stroke, however, is not known. This study investigates the potential benefits~     of early tracheostomy in ventilated critically ill patients with ischemic or hemorrhagic~     stroke.~   "
176028|NCT01261078|"~     Intrathecal epinephrine has been known to increase the duration of spinal anesthesia, or~     increase the quality of anesthesia. However, there is still a controversy, and the mechanism~     of epinephrine is recently suggested as a modulator of pain information in the spinal cord.~     Therefore, the investigators try to investigate the dose sparing effect of intrathecal~     epinephrine for spinal anesthesia with bupivacaine.~   "
176029|NCT01261065|"~     The overall hypothesis of this application is that the improvement in LV ejection performance~     following treatment with betablockers is due, at least in part, to improvement in intrinsic~     myocardial contractility.~   "
176030|NCT01261052|"~     The purpose of this research study is to test an automated blood glucose control system that~     includes a new component designed to adapt to stress. The importance of this component is~     that when Type 1 Diabetics are stressed (for example, from illness or infection), their body~     is resistant to the effects of insulin. The investigators will be adjusting their blood~     glucose using insulin and glucagon and making their body less sensitive to insulin with a~     steroid, hydrocortisone. Insulin is a hormone that lowers blood glucose. Glucagon raises~     blood glucose when it is low. Both are natural hormones made by people without diabetes.~     Hydrocortisone is a steroid that will increase their blood glucose temporarily and will be~     given every 4 hours. All subjects will participate in two 33 hour experiments. One experiment~     will use the adaptive version of the sensor-based glucose control system. The other study~     will use the original version of the control system, without the adaptive component, for the~     first 13 hours. Then, the adaptive component will be added to the glucose control system for~     the remaining 20 hours of the study. Our primary goal is to assess the effectiveness of the~     adaptive component to control glucose levels in the presence of steroid-induced insulin~     resistance in persons with Type 1 Diabetes Mellitus.~   "
176031|NCT01261039|"~     Background:~      Some patients do not readily absorb vitamin D from intestine. These patients may be helped by~     ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to~     ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed~     to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or~     supplements.~      Vitamin D is important for bone, and long-term vitamin D deficiency can lead to osteoporosis.~     Vitamin D may also be important for the immune system—including autoimmune diseases—and the~     cardiovascular system.~      Purpose:~      The main purpose of the study is to learn more about the production of vitamin D3 in the~     skin, by ultraviolet radiation.~      Study Course:~      Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be~     exposed to light in a solar bed for approximately 10 minutes on the first day, but only one~     of the solar beds wields ultraviolet rays. The other has a filter, which filters out the~     ultraviolet rays.~      Blood samples are drawn on the first day at following times: Before solar bed, after at 15~     minutes, 1, 2, 4 and 6 hours.~      Day 1,2,3 and 7 after solar bed exposure:~      Blood samples are drawn and adverse events are registered.~   "
176032|NCT01261026|"~     OBJECTIVE: This study evaluated serum vascular endothelial growth factor (VEGF)~     concentrations in women with ectopic pregnancy (EP), abnormal intrauterine pregnancy (aIUP)~     and normal intrauterine pregnancy (nIUP).~      METHODS: This was a prospective, case-control study comparing serum VEGF concentrations among~     72 women with ectopic pregnancy (n=35), abnormal IUP (n=15) and normal IUP (n=22) matched for~     gestational age. For the determination of serum VEGF concentration a solid phase sandwich~     ELISA was used. Patients were stratified according to serum VEGF above or below 200pg/mL.~      RESULTS: The serum level of VEGF was significantly higher in women with ectopic pregnancy~     (median 211.1 pg/mL; range 5 - 1017.0 pg/mL) than in women with normal IUP (median 5 pg/mL;~     range 5- 310.6 pg/mL) P < 0.0001. Serum VEGF concentrations did not show any statistically~     significant difference between women with aIUP (median 231.9 pg/mL range 5 - 813.7 pg /mL )~     and EP (median 211.1 pg/mL range 5 - 1017.0 pg/mL). When cut-off concentrations of 200 pg/mL~     for VEGF were used, a nIUP could be distinguished from an unviable (EP and aIUP) with a~     sensitive of 53%, specificity of 90.9%, a positive predictive value of 92.9% and a negative~     predictive value of 46.5%..~      CONCLUSIONS: Serum VEGF could not distinguish between an EP and an aIUP. However, serum VEGF~     concentrations above 200 pg/mL could discriminate a nIUP from an unviable pregnancy (EP or~     aIUP) with a PPV of 92.9%.~   "
176033|NCT01261013|"~     The purpose of this study is to properly analyse the visual and refractive outcomes of~     implantation of KeraRing intrastromal corneal ring segment (ICRS) at the different stages of~     keratoconus.~   "
176036|NCT01260974|"~     The aim of the study is to determine viable use of caspofungin in post-OLTx patients, and to~     demonstrate in particular the effectiveness, understood as the ability to reduce the~     incidence of invasive fungal infections, and to assess the ability to reduce the risk and~     incidence of side effects (toxicity) which may arise in transplant patients treated with~     other drugs, especially in individuals recognized as high risk (e.g. renal failure).~   "
176037|NCT01260961|"~     Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are~     starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3~     fatty acid found in the brain and a component of fish oil, has any effects on the symptoms of~     autism.~      We propose to carry out a trial to test the effect of DHA compared to a placebo (a pill with~     no drug in it) on several aspects of autism in children and adolescents, in a 12-week~     clinical study with children or adolescents in the age group of 5-17 with a diagnosis of~     Autism Spectrum Disorder. Additionally this trial will study genes related to the therapeutic~     agent, DHA, and biomarkers related to DHA in the urine.~   "
176038|NCT01260948|"~     This study investigated the relative bioavailability (rate and extend of absorption) of~     Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA~     with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc.,~     following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult~     subjects administered under non-fasting conditions.~   "
176039|NCT01260935|"~     The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill~     anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see~     whether one is better than the other.~   "
176040|NCT01260922|"~     This study investigated the relative bioavailability (rate and extent of absorption) of~     Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA~     with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc.,~     following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult~     subjects administered under fasting conditions.~   "
176041|NCT01260909|"~     In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal~     X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose~     delivery typically takes 2 to 5 minutes depending on the delivery technique used for~     treatment. A tumor target may change its position during the dose delivery process. The goal~     of this project is develop a real-time imaging strategy to monitor the tumor position during~     dose delivery and evaluate its potential clinical impact.~   "
176042|NCT01260896|"~     The objective of this study was to compare the rate and extent of absorption of venlafaxine~     hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference)~     administered as 1 x 150 mg extended-release capsule under fasting conditions.~   "
176043|NCT01260883|"~     Infants handle ketorolac differently than adults. Study of handling of this pain medication~     given to infants following surgery. Detailed analysis of how the drug is eliminated from age~     2 months to 18 months. Compared morphine use in infants who received the drug to the group~     getting placebo. Safety testing for kidney and liver function, breathing measured by~     continuous oximetry, and any bleeding issues.~   "
176044|NCT01260870|"~     To evaluate the procedural safety and to identify and characterize therapeutic and functional~     endpoint assessments in subjects with documented critical limb ischemia who received~     treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only.~   "
176045|NCT01260857|"~     Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2~     follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and~     secondary outcomes, respectively.~   "
176046|NCT01260844|"~     Phase 1, drug-drug interaction study to evaluate the effects of Briakinumab on hte~     pharmacokinetics of single doses of CYP substrate in subjects with moderate to severe~     psoriasis.~   "
176047|NCT01260831|"~     The purpose of this study is to evaluate the impact of Bedside Paediatric Early Warning~     System (Bedside-PEWS) on early identification of children at risk for near and actual~     cardiopulmonary arrest, hospital mortality, processes of care and PICU resource utilization.~   "
176048|NCT01260818|"~     Tranexamic acid has been shown to reduce postoperative blood losses and transfusion~     requirements in a number of types of surgery. Most trials in orthopedic surgery have been~     conducted intravenously in arthroplasty, hip fracture and spine surgeries. This study would~     aim to see the effect of topical use of tranexamic acid in reduction of blood loss and~     transfusions for total hip arthroplasty~   "
176049|NCT01260805|"~     A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the~     Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify~     through a single dose study, if the two formulations of Ethinylestradiol 0,02mg + Gestodene~     0,075mg sugar coated tablets are bioequivalent when administered at the same dose and under~     fasting conditions.~   "
176050|NCT01260792|"~     Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not~     validated in France. This clearly hampers the development of the diagnosis and the monitoring~     of patients but also research in this domain. This study is conceived to collect data in the~     general population of children aged from 4 to 18 years in public schools in the city of Nice.~      Children are pseudo-randomly selected from classes of randomly selected schools in the city~     of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and ask~     parents to fill out a similar set of questionnaires regarding their child's behaviour at~     home. Since ADHD has a strong genetic components, parents are also asked to fill out~     questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.~      Additionally, known factors related to ADHD and other disorders as well as other putative~     factors are tested in the epidemiologic study.~   "
176051|NCT01260779|"~     This compassionate use protocol provides expanded access for investigational use of PV-10 in~     cancer patients who are not eligible for an existing PV-10 clinical trial, for whom there is~     no comparable or satisfactory approved alternative therapy and whom, in the opinion of the~     investigator, may benefit from PV-10 administration.~   "
176052|NCT01260766|"~     The purpose of this study was to demonstrate the effect of short treatment with active OPLON~     patches on Acne.~   "
176053|NCT01260753|"~     The purpose of this study is to explore the activity of UR-63325 in a model of allergic~     rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise~     healthy.~   "
176054|NCT01260740|"~     Background:~      - Two areas on the surface of the brain, the dorsolateral prefrontal cortex (DLPFC) and motor~     cortex (MC), play a key role during learning. Researchers are interested in determining the~     effect that transcranial magnetic stimulation (TMS) on the DLPFC and MC has on participants'~     performance of learning tasks. By studying the effect of TMS on reaction time, learning, and~     memory, researchers hope to better understand how to treat conditions such as Parkinson's~     disease and traumatic brain injury that affect these parts of the brain.~      Objectives:~        -  To study the effects of transcranial magnetic stimulation on the dorsolateral prefrontal~          cortex and motor cortex.~        -  To learn which areas of the brain are used to perform certain learning and memory tasks.~      Eligibility:~      - Healthy, right-handed individuals between 18 and 70 years of age.~      Design:~        -  Participants will be screened with a physical and neurological examination and a medical~          and psychiatric history.~        -  Participants will be asked to take part in one of five different parts of this study.~          Most participants will have four 2-hour visits to the National Institutes of Health~          Clinical Center. Some participants (those involved in Part 5) will have only one 2-hour~          visit.~        -  Parts 1 and 2 (four visits): Participants will have TMS, and then do a learning task~          that may provide a small monetary reward. On the first visit, before the TMS,~          participants will take an intelligence test based on reading aloud the words given on a~          card. Participants who have not had a routine magnetic resonance imaging (MRI) scan of~          the brain within the past year will also have a scan.~        -  Parts 3 and 4 (four visits): Participants will have a functional MRI scan while doing a~          learning task that may provide a small monetary reward. On the first visit, before the~          functional MRI, participants will take an intelligence test based on reading aloud the~          words given on a card. Participants who have not had a routine magnetic resonance~          imaging (MRI) scan of the brain within the past year will also have a scan.~        -  Part 5 (one visit): Participants will take an intelligence test based on reading aloud~          the words given on a card. Then, participants will have TMS followed by a functional MRI~          scan. During the functional MRI, participants will do a button-pressing task that may~          provide a small monetary reward.~        -  Participants will also be asked to provide a small blood sample for genetic analysis.~   "
176055|NCT01260727|"~     The purpose of this study is to evaluate the safety of and immune response to an HIV vaccine,~     administered using two different devices, followed by a vaccine boost, in healthy,~     HIV-uninfected adults.~   "
176056|NCT01260714|"~     This phase I trial studies the best dose of azacitidine and to see how well it works with~     mitoxantrone hydrochloride and etoposide in treating older patients with acute myeloid~     leukemia that has a lower chance of responding to treatment or higher risk of returning (poor~     prognosis). Drugs used in chemotherapy, such as azacitidine, mitoxantrone hydrochloride, and~     etoposide, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more cancer cells.~   "
176057|NCT01260701|"~     This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients~     with advanced gastric or gastroesophageal junction cancer. Akt inhibitor MK2206 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
176058|NCT01260688|"~     This randomized phase II trial is studying the side effects and how well giving cediranib~     maleate together with or without dasatinib works in treating patients with hormone-resistant~     prostate cancer resistant to treatment with docetaxel. Cediranib maleate and dasatinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by~     blocking blood flow to the tumor. It is not yet known whether giving cediranib maleate~     together with dasatinib or alone is an effective treatment for prostate cancer.~   "
176059|NCT01260675|"~     Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.~   "
176060|NCT01260662|"~     This will be a randomized trial of propofol versus the combination of propofol and ketamine~     for procedural sedation for procedures in the Emergency Department (ED). Propofol produces~     sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County~     Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is~     also frequently used in the ED in children and sometimes in adults. It has been proposed that~     by combining the two agents, the negative side effects of respiratory depression and~     hypotension associated with propofol, and the negative effects of dysphoria and vomiting~     associated with ketamine, can be avoided.~      In the proposed study, patients seen in the ED who will require procedural sedation for a~     painful procedure will be randomized to receive either propofol or propofol and ketamine.~     During the procedure, patients will be monitored per the standard of care, including use of a~     cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample~     end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully~     completed and the patient has returned to his/her baseline mental status, the patient will be~     asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure,~     memory of the procedure, and overall satisfaction with the procedure.~   "
176061|NCT01260649|"~     Electroconvulsive therapy (ECT), is considered the most effective treatment for severe~     treatment resistant major depressive disorder (MDD), but it requires about 3 weeks of~     treatments and can cause considerable acute deficits in memory. It would be a major advance~     in treatment if ECT could work faster with fewer treatments and result in decrease incidence~     of memory problems. Ketamine is an excellent candidate for augmentation of ECT because of its~     acute effects on depression, its short half-life, and its safety profile when given at low~     doses. Ketamine is given as an infusion and could easily be incorporated into the routine~     management of patients undergoing ECT, but has never been evaluated prospectively in this~     context.~      The investigators propose to assess the efficacy, feasibility, tolerability and safety of~     N-methyl-D-aspartate antagonist augmentation of ECT using ketamine.~   "
176062|NCT01260636|"~     To compare two gadolinium contrast agents in terms of global paired diagnostic preference~     (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid,~     renal/abdominal and peripheral arteries~   "
176063|NCT01260623|"~     The objective of the investigators pilot study is to assess the pharmacokinetic profile of~     two corticosteroid drugs, prednisone and prednisolone, in children who present to the~     pediatric emergency department with an asthma exacerbation. The investigators hypothesis is~     that the pharmacokinetic profile in this population will be similar to healthy children and~     adults.~   "
176064|NCT01260610|"~     Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although~     it may not be sustained for long. Also it remains unknown if combination of more potent~     analogues is more beneficial than individual drugs. Thus this study is carried out to~     determine the efficacy and safety of combination of tenofovir plus telbivudine (two most~     potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week~     open labelled, prospective, randomized, multicentric study. The patient will receive either~     tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the~     non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will~     continue receiving tenofovir plus telbivudine for 104 weeks.~   "
176180|NCT01259089|"~     Hsp90 inhibitor AUY922 and erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the~     side effects and best dose of Hsp90 inhibitor AUY922 when given together with erlotinib~     hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small~     cell lung cancer.~   "
176065|NCT01260597|"~     The purpose of this proposed study is to develop, refine and test the use of Interactive~     Voice Response (IVR) technology as a means of increasing re-engagement of low income smokers~     in telephone support for tobacco cessation (quit lines). If this strategy proves to be~     acceptable and feasible, it may offer a technological solution to increase access to and~     utilization of a widely available evidence-based form of behavioral treatment for low income~     smokers.~      The primary aims of this research are to:~        1. Develop an IVR system that delivers tailored audio messages to increase low income~          smokers' re-engagement in treatment offered by two state quit lines (Washington and~          Indiana). The investigators will develop: a) a menu of audio messages that can be~          delivered by an IVR system; b) an IVR algorithm (i.e., a set of decision rules) to make~          proactive automated calls to deliver brief, tailored messages for re-engaging low income~          smokers who previously used the quit line.~        2. Evaluate the feasibility and efficacy of an IVR system as a tool to re-engage low income~          smokers into quit line treatment measured by number of IVR calls answered, number of~          smokers who re-engage in treatment and satisfaction with IVR calls. Hypothesis 2.1 - It~          is hypothesized that the rates of re-engagement into treatment among those receiving the~          IVR intervention will be higher than smokers not proactively invited to re-engage in~          quit line services.~   "
176066|NCT01260584|"~     This study is being conducted to determine if smoking will influence the platelet aggregation~     inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any~     effect on the plasma concentrations of the active metabolite of prasugrel and the active and~     inactive metabolites of clopidogrel.~      The primary hypothesis is that smoking status will influence the antiplatelet effects and~     active metabolite concentrations of clopidogrel but will have no impact on prasugrel's~     antiplatelet effects or active metabolite concentrations.~   "
176067|NCT01260571|"~     Sixty two subjects will take part in this study. The study is unic arm. The subjects used the~     product once and will be evaluated in the regression of pimples in the times 0,4,6,8 and 24~     hours after application.~      A follow-up visit will be made 24 hours after initiation of treatment.~   "
176068|NCT01260558|"~     The objective of this pilot study is to compare the PFS-eluting stent (ISAR Rapa G1) with the~     PPS-eluting stent (Cypher®) regarding uncovered stent strut segments at 5 years.~   "
176069|NCT01260545|"~     The purpose of this study is to examine the safety and tolerability of CA-18C3 in subjects~     with hematologic malignancies, as well as look at the preliminary efficacy of IL-1alpha~     blockade.~   "
176070|NCT01260532|"~     Autoimmune thyroid disease is the most common organ-specific autoimmune disease. AITD include~     Graves' disease and Hashimoto's thyroiditis. Although the pathogenesis of AITD remains~     unclear, it is generally thought that the mechanisms of the disease is a complex disease in~     which susceptibility genes and environmental triggers act in concert to initiate the~     autoimmune response to the thyroid.~      The initial step of thyroid autoimmunity is the activation of T cells. The activation of T~     cell requires two signals: firstly, thyroid follicular cells or antigen presenting cells~     binds to T cell receptor through antigenic HLA complex. Secondly, the activation of T cells~     is also required the interaction of costimulatory molecules between thyroid follicular cells~     and immune cells, including CTLA-4, CD 40, CD28, ICOS. PPAR- is a kind of intranuclear~     transcription factor, associated with adipogenesis and inflammation. Some reports showed that~     PPAR- polymorphism may have a protective effect from Graves' ophthalmopathy.~      The goal of the study is to investigate the relationship among SNP and mRNA of costimulatory~     molecules and PPAR- , serum cytokine including TNF- and sIL-2R, and clinical characteristics~     in AITD patients. From the study, we hope to clarify the role of costimulatory molecules and~     PPAR- polymorphism in AITD.~   "
176071|NCT01260519|"~     The project tests the incidence of femoral arterial sheath thrombus formation during~     diagnostic coronary angiography and effect of intravenous (iv) heparin bolus administration~     in reducing this risk in comparison to placebo.~   "
176072|NCT01260506|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in~     patients with Relapsed Glioblastoma Multiforme.~   "
176073|NCT01260493|"~     The present study Continuum of care for frail elderly people form part of the research~     programme Support for frail elderly persons - from prevention to palliation~     (www.vardalinstitutet.net) which comprises research into three interventions. The program~     comprises interventions addressing frail elderly people in different phases of the~     disablement process, from elderly people who are beginning to develop frailty to very frail~     elderly people receiving palliative care.~      The intervention Continuum of care for frail elderly people addresses elderly people who~     are frail and that have a great risk of high health care consumption. The hypothesis is that~     an intervention program for frail elderly people can reduce the number of visits to the~     emergency department, increase the life satisfaction and maintain the functional ability. The~     intervention, including an early geriatric assessment at the emergency department, early~     family support, a case manager in the community with a multi-professional team and active~     follow-up by the case manager, contributes to early recognition of the elderly people's need~     of information, care and rehabilitation and of informal caregivers' need of information. It~     enhances the transfer of information and integrates the care between different caregivers and~     different care levels, thereby better recognize frail elderly people's needs. Specifically,~     this study is expected to show that the intervention has a positive effect on the frail~     elderly person's functional ability, life satisfaction, satisfaction with health and social~     care, and health care consumption.~   "
176074|NCT01260480|"~     The purpose of this study is to determine whether [18F]-ML-10 used in conjunction with PET~     imaging is effective as an imaging tool for the early detection of response of oncological~     tumors in the lungs,head and neck to chemoradiation therapy.~      The study will evaluate the potential of [18F]-ML-10 used in conjunction with PET imaging to~     distinguish early during the course of chemoradiation therapy between a tumor that responds~     to the therapy, and a tumor that does not respond to the therapy. Currently, this distinction~     is available to the physician several weeks or months after completion of therapy, using~     anatomical imaging (for example Computed Tomography [CT] or Magnetic Resonance Imaging~     [MRI]).~   "
176181|NCT01259076|"~     Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss~     affects breast density in women who are at increased risk for breast cancer.~   "
176075|NCT01260467|"~     The purpose of this study is to determine if a medication called memantine is effective in~     treating glioblastoma. Memantine targets a specific receptor, called a glutamate receptor,~     which is thought to be involved in the growth of brain tumors. It has previously been studied~     for other types of conditions, such as Alzheimer's disease, but it has not yet been evaluated~     in the treatment of brain tumors. The investigators will also be determining how common it is~     for patients with brain tumors to have side effects to memantine. Memantine will be taken by~     mouth twice a day.~   "
176076|NCT01260454|"~     Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial~     hypertension, a life threatening disease of the lung blood vessels. Unfortunately,~     treprostinil is irritating to the skin and many patients experience intense pain at the~     infusion site for the first 7-10 days after placing a new subcutaneous infusion site.~      Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of~     post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that~     pretreatment of an area of skin with Qutenza would decrease the pain associated with a new~     treprostinil infusion site. The investigators hope that Qutenza will decrease both the~     intensity of the pain and the duration of the pain after patients place a new treprostinil~     infusion site.~      In this initial study, the investigators will provide Qutenza in open-label, unblinded~     fashion and ask patients to rate their pain using a diary tool with which they are already~     comfortable.~   "
176077|NCT01260441|"~     Each year in the United States, 300,000 people suffer from a Cardiac Arrest (CA), and of~     them, there is a 90% mortality rate. Out-of-Hospital arrests, in particular, have a 1-5%~     survival to hospital discharge. High quality CPR is crucial to lowering the mortality rate~     and increasing survival, yet only 15-30% of out-of-hospital CA victims receive bystander CPR.~     Studies have shown that prompt administration of CPR dramatically improves outcomes. In a~     recent study from Switzerland, lay bystander CPR doubled the survival rate at one month. Our~     study will look to train family members of at-risk cardiac patients in the skills of CPR~     through the American Heart Association's (AHA) CPR Anytime Friends and Family Personal~     Learning Program (CPR Anytime) to see if these family members are able to learn and perform~     quality CPR in the event that their family member should suffer a cardiac arrest.~   "
176078|NCT01260428|"~     Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present~     study is to investigate whether increased expiratory pressure within the thorax is able to~     improve oxygenation during hypoxic hypoxia.~   "
176079|NCT01260415|"~     This is a phase II study to assess whether treatment with chemotherapy drugs FOLFOX~     (5-Fluorouracil (5FU), Oxaliplatin (Eloxatin) and Leucovorin (Folinic Acid)) or FOLFIRI~     (5-Fluorouracil (5FU), Irinotecan (Camptosar) and Leucovorin (Folinic Acid))and panitumumab~     before and after surgery can improve outcome in patients with liver metastases (the cancer~     has spread to other parts of the body such as the liver) that are resectable (can be~     surgically removed), from colorectal cancer that have a non mutant (wild-type) K-ras gene.~      FOLFOX/FOLFIRI is an intravenous (given by vein) chemotherapy combination that is approved~     for colorectal cancer while panitumumab is also an intravenous drug and have been approved~     for treatment of refractory (not responding treatment) metastatic colorectal cancer whose~     cancers have the K-ras gene. These drugs are not approved for the treatment of colorectal~     cancer liver metastases (CRCLM) who can have surgery.~      Patients will receive FOLFOX/FOLFIRI and panitumumab for four 2-week cycles before surgery.~     Surgery will be done no sooner than 4 weeks and no later than 8 weeks, after completion of~     the fourth cycle of chemotherapy.~      If the liver metastases after the chemotherapy and surgery decreases or stops growing, then~     chemotherapy will be given after surgery. Treatments will start no sooner than 4 weeks, and~     no later than 12 weeks, after surgery. Patients will receive a maximum of 8 cycles of~     treatment with the combination of drugs and then receive panitumumab alone for a maximum of~     12 cycles.~      On treatment visits, patients will also have tests and procedures done. As part of the study,~     patients will provide archival tumor tissue and sample of tissue removed from surgery for~     K-ras testing. Patients will also be given the option of allowing the collected tissue for~     research (biomarker) studies and banking for future studies.~   "
176080|NCT01260402|"~     Biventricular pacing is a validated treatment for patients suffering from heart failure~     resistant to medical treatment. However, up to 30% of the patients are non responsive to this~     strategy using the coronary sinus approach to pace the Left Ventricle (LV).~      It has been demonstrated that the magnitude of the improvement was highly dependant on the LV~     pacing site. The coronary sinus approach rarely offers more than 1 or 2 potential pacing~     sites. Resynchronisation using a transeptal approach to pace the left ventricle on the~     cardiology has been shown feasible on small series. We therefore would like to compare these~     two approached in a randomised prospective study to confirm the hypotheses that endocardial~     LV pacing by offering multiple choices for the pacing sites reduces the number of non~     responders and is associated with greater hemodynamic benefit when compared to the~     conventional coronary sinus approach.~   "
176081|NCT01260389|"~     This study would like to test the hypothesis that a pharmaceutical care intervention would~     result in an improved drug adherence and inhalation technique in Chronic Obstructive~     Pulmonary Disease (COPD) patients over a 3 month-period.~   "
176082|NCT01260376|"~     This study will investigate free fatty acid and VLDL-TG metabolism before and during exercise~     with and without pharmacological antilipolysis by the niacin antagonist Acipimox. Main~     focuses will be VLDL-TG and free fatty acid metabolism as well as expression of membrane~     proteins in fat- and muscle biopsies.~   "
176083|NCT01260363|"~     Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration~     analgesia with femoral nerve block after.~   "
176084|NCT01260350|"~     This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and~     without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in~     subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.~   "
176085|NCT01260337|"~     The purpose of this research study to find out whether a pre-packaged, portion controlled~     diet with a group behavior modification program or group diabetes support and education, is a~     safe and effective way for people with type 2 diabetes to lose weight and manage their~     diabetes.~   "
176086|NCT01260324|"~     The objectives of this study were to: (1) evaluate the natural history of non-arteritic~     anterior ischemic optic neuropathy (NAION); (2) estimate the population incidence of NAION;~     and (3) identify potential risk factors for NAION.~   "
176087|NCT01260311|"~     This is an observational study and will determine the safety profile of fesoterodine in~     Filipino patients prescribed the drug. This is in compliance with the requirements of the~     Philippine Food and Drug Administration.~   "
176088|NCT01260298|"~     The objective of this study is to observe body contour changes following treatment using the~     MC1 device.~   "
176089|NCT01260285|"~     The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery~     patients.~   "
176091|NCT01260259|"~     Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved~     outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to~     elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory~     and cell survival pathways, and thus protect remote organs against future ischemic injury. We~     hypothesize that compared to sham treatment, RIPC will be associated with decreased~     post-operative acute kidney, myocardial, and lung injury.~   "
176092|NCT01260246|"~     This is a randomized, double-blind, placebo-controlled trial evaluating the impact of~     sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic~     steatohepatitis (NASH) on improving liver disease based on biopsy results. The effect of~     sitagliptin on other measures such as hormones modifying insulin release and sensitivity~     (termed adipocytokines), fat distribution, and biomarkers of cardiovascular risk will also be~     evaluated.~   "
176093|NCT01260233|"~     The purpose of this study is to determine whether a perioperative smoking cessation program,~     implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of~     smoking cessation or reduction. Intraoperative and immediate postoperative complications will~     also be compared.~   "
176094|NCT01260220|"~     An isolation-limited segmental antral approach to pulmonary vein isolation is as effective in~     achieving long-term freedom from atrial fibrillation as the standard anatomic,~     circumferential antral ablation.~   "
176095|NCT01260207|"~     The purpose of this study is to determine whether interactive voice response (IVR) technology~     can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best~     practice guidelines (BPGs).~      The study hypothesis is that ACS patients who are contacted by IVR technology will be more~     likely to receive care as recommended in the BPGs than those followed by usual care.~   "
176096|NCT01260194|"~     This open-label, multi-center study will evaluate the efficacy and safety of Herceptin~     (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients~     with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction.~     Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin~     as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until~     disease progression.~   "
176097|NCT01260181|"~     This single arm, open-label study will evaluate the efficacy and safety of erlotinib~     (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer~     (NSCLC) with epidermal growth factor receptor (EGFR) mutations.~   "
176098|NCT01260168|"~     The objective of this study is to confirm the sensitivity of a stool DNA test for detection~     of colorectal cancer and pre-cancer.~      Another objective is to provide anonymous, clinically characterized specimens for a~     bio-repository for future colorectal cancer-related test development.~   "
176099|NCT01260155|"~     This study will be a single-center, open-label, randomized, 3-treatment crossover~     bioavailability study of single oral doses of E5501 old tablet formulation under fasted~     conditions and a new tablet formulation administered under fed and fasted conditions in~     healthy subjects.~   "
176100|NCT01260142|"~     This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of~     fospropofol disodium in comparison to propofol. In addition, the study will compare the~     maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.~   "
176101|NCT01260129|"~     Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical~     study is designed to demonstrate that the newly adopted dose is not inferior to the existing~     dose in its efficacy and safety.~   "
176102|NCT01260116|"~     This study is going to determine the efficacy, tolerability and safety of ziprasidone in 120~     schizophrenic patients with depressive symptoms. The study will be carried out at 2 mental~     centers in China. Subjects will be required to attend the center at screening, baseline,~     Weeks 1, 2, 4 ,6 and 8 or early termination visit.~      At screening, patients underwent psychiatric and physical examination, standard lab tests,~     and an Electrocardiograph.~      At baseline, if they continued to be eligible, they began ziprasidone 20 mg twice daily.~      Depending on response and tolerability, ziprasidone could be gradually escalated to a maximum~     of 80 mg twice daily.~   "
176103|NCT01260103|"~     Primary Objectives~      To compare progression free survival (PFS), the time from randomization to progressive~     disease,in children with optic pathway glioma (OPG) age ≥ 6 months to < 18 years, who receive~     combination antineoplaston therapy (ANP therapy) vs. temozolomide (TMZ); study subjects will~     have 1) received prior treatment with carboplatin or cisplatin, which was terminated~     secondary to toxicity or progression of OPG, or 2) developed recurrence of OPG after~     completion of carboplatin or cisplatin therapy. PFS data will be censored on the date of the~     last tumor assessment documenting absence of progression for study subjects:~        -  Who are alive, on study and are progression-free at the time of the analysis;~        -  Who discontinue, receive no subsequent therapy and are progression-free at the time of~          the analysis;~        -  Who are given/change therapy other than the study treatment prior to observing~          progression;~        -  Who discontinued (due to personal preference or toxicity) with a change in therapy,~          withdrew, or was lost to follow-up;~        -  For whom documentation of disease progression or death occurs after ≥ 2 consecutive~          missed tumor assessments.~             -  To describe the toxicity profile for ANP therapy vs. TMZ.~      Secondary Objectives:~        -  To compare overall survival (OS) for subjects treated with ANP therapy vs. TMZ;~        -  To compare disease stabilization rates for subjects treated with ANP therapy vs. TMZ;~        -  To compare complete response (CR), partial response (PR), stable disease (SD), and~          progressive disease (PD) rates for subjects treated with ANP therapy vs. TMZ.~   "
176167|NCT01259258|"~     We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who~     received 2 ml intratunical space injection of methylene blue before spermatic vein ligation~     with 40 controls in whom no mapping technique was adopted in the period between January 2008~     and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were~     assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy,~     pain or other complications with mean follow up was 15+ 7months.~   "
176168|NCT01259245|"~     The purpose of this study was to compare the self-efficacy and quality of life parameters of~     Chronic Obstructive Pulmonary Disease(COPD)patients who underwent pulmonary rehabilitation~     with and without Tai Chi elements incorporated in the exercise component in a General~     Out-patient setting.~   "
176104|NCT01260090|"~     Traumatic brain injury has a high morbidity and mortality in both civilian and military~     populations. Blast and other mechanisms of traumatic brain injury damage the brain by causing~     neurons to disconnect and atrophy. Such traumatic axonal injury can lead to persistently~     vegetative and minimally conscious states, for which extremely limited treatment options~     exist, including physical, occupational, speech and cognitive therapies.~      More than 50,000 patients have received vagus nerve stimulation for epilepsy and depression.~     In addition to decreased seizure frequency and severity, patients report enhanced mood,~     reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and~     improved cognition, memory, and quality of life.~      The purpose of this study is to demonstrate objective improvement in clinical outcome by~     placement of a vagus nerve stimulator in patients who are recovering from severe traumatic~     brain injury. Our hypothesis is that stimulation of the vagus nerve results in increased~     cerebral blood flow and metabolism in the forebrain, thalamus and reticular formation, which~     promotes arousal and improved consciousness, thereby improving outcome after traumatic brain~     injury resulting in minimally conscious or persistent vegetative states. If this study~     demonstrates that vagus nerve stimulation can safely and positively impact outcome, then a~     larger randomized prospective crossover trial will be proposed.~      The investigators will achieve this objective by evaluating whether vagus nerve stimulation~     impacts clinical recovery from minimally conscious or persistent vegetative states caused by~     traumatic brain injury as assessed by the FIM™ instrument and Functional Assessment Measure~     (FIM+FAM) as well as the JFK Coma Recovery Scale Score. The investigators will also evaluate~     whether vagus nerve stimulation alters resting and activational functional MRI.~      Twelve patients will be enrolled in this initial crossover pilot study. These patients will~     have sustained a severe traumatic brain injury (Disability Rating Scale score of 22 to 29)~     more than twelve months from starting the study, and have no other concurrent active severe~     medical problems. Baseline EEG and magnetic resonance imaging (MRI) will be performed prior~     to left vagus nerve stimulation implantation. Patients will be randomized to alternating~     three month periods with the device on or off. Outcomes will be assessed at three month~     intervals with the FIM™ instrument and Functional Assessment Measure (FIM+FAM) and JFK Coma~     Recovery Scale by a neuropsychologist blinded to the status of the device. Outcomes will also~     be assessed using quantitative eye movement tracking and functional magnetic resonance~     imaging. Patients will cross over every 3 months and be followed for at least 18 months.~   "
176105|NCT01260077|"~     Objective: At present, vestibular evoked myogenic potentials are analyzed only in the time~     domain. A technique to evaluate this potential in the frequency domain could provide more~     information, but has only been applied within the last year. Design and Study Sample: In this~     study we recorded vestibular evoked myogenic potential in the time domain, in 156 ears of 78~     normal-hearing young adults, at frequencies of 250, 500, 1000 and 2000 Hz, with intensity of~     90 dB nHL. Next, the steady state vestibular evoked myogenic potential was recorded at the~     same carrying frequencies, modulated at 20, 37, 40, 43, 70, 77 and 80 Hz. Results: The~     responses found by modulated frequency, regardless of carrier, recorded a higher presence of~     peaks and mean amplitudes between 20 and 70 Hz, especially at 40 Hz. Conclusions: The results~     show that the observation technique in the frequency domain is feasible and shows a strong~     association with the time domain for recording vestibular evoked myogenic potentials, at~     carrying frequencies of 250, 500, 1000 or 2000 Hz.~   "
176106|NCT01260064|"~     1. Laparoscopic appendectomy may not be a superior procedure when compared with open~     appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the~     technical diffuculty and overall costs.~   "
176107|NCT01260051|"~     Currently, no clear consensus exists regarding the effect of epidural anesthesia upon~     breast-feeding. In theory, epidurals may increase breast-feeding failure via inadequate~     maternal milk production, deficiencies in neonatal neurobehavior, or both, but most studies~     have failed to separate these potential mechanisms. The present study examines whether~     epidural duration correlates with 1) likelihood of breast-feeding at hospital discharge and~     2) neonatal neurobehavioral deficits in feeding, as measured by the L&A components of the~     standardized, validated LATCH scoring system.~   "
176108|NCT01260038|"~     This is an observational study to evaluate the feasibility of the implementation of a~     personalized treatment strategy based on specific tumor marker (f.i. EGFR-mutation) in the~     routine clinical care setting in the Antwerp region (Belgium).~   "
176109|NCT01260025|"~     1. MTD and DLT of M2ES~        2. Pharmacokinetics of M2ES~   "
176110|NCT01260012|"~     Liver fibrosis is the most serious complication of schistosomiasis mansoni. However only~     limited proportion of subjects with infection develop this pathology and there is limited~     knowledge on risk factors for the differential morbidity patterns observed in endemic~     communities. Our preliminary cross-sectional study indicated that serum levels of~     antioxidants may be related with the development of fibrosis. The present project is a~     randomised double blinded placebo controlled prospective study investigating the role of food~     based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with regards~     to the extent of fibrosis reversal.~   "
176111|NCT01259999|"~     Dietary intake in frail elderly is often lower than estimated needs due to the combined~     effects of the anorexia of ageing, frailty and the presence of acute and chronic disease. The~     objectives of the present study are to assess the effects of an oleic acid rich formula~     fortified with micronutrients on energy intake, vitamin- and mineral status, muscle strength~     and mobility. The investigators have recently performed a similar study in an acute ward~     setting without micronutrients.~   "
176112|NCT01259986|"~     The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible~     light laser in the treatment of various recalcitrant forms of vitiligo.~   "
176113|NCT01259973|"~     The purpose of this study is to determine in healthy volunteers treated with typical or~     atypical antipsychotics -AP-, the relationship between genetic polymorphisms in cytochrome~     genes CYP2D6 (*3, *4, *5, *6 and Nxn) and CYP3A5 (*3) with antipsychotic pharmacokinetics,~     occupancy of striatal dopaminergic receptors and the appearance of extrapyramidal~     symptomatology -EPS-.~   "
176114|NCT01259960|"~     Being confronted more and more with obese as well as older patients, minimally invasive~     surgery is said to keep the surgical trauma low. The prospective long-term evaluation is the~     continuous monitoring of patients undergoing lumbar minimally invasive fusion surgery and~     analyzing the effect of body mass index (BMI) and wound healing.~   "
176169|NCT01259232|"~     To investigate the brain abnormalities and the association with gene in schizophrenia~     patients and their relatives.~   "
176170|NCT01259219|"~     Open label pharmacokinetic RBT dose-finding study in young (≤ 5 year old) HIV-infected~     children receiving a LPV/RTV-based ART regimen and who have a recent history of completing TB~     treatment.~   "
176171|NCT01259206|"~     Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate~     from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by~     decreased ability of tissue repair and increased reactive ossification. Thus, the~     investigators aimed to determine CS incidence in asymptomatic obese subjects with and without~     type 2 diabetes mellitus (T2DM).~   "
176223|NCT01258530|"~     This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated~     oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will~     be administered in the fasting state.~   "
176115|NCT01259947|"~     Abstract Background: There is no universally accepted and effective prophylaxis of migraine~     headache episodes. Thus the investigators aimed to investigate the effects of Lippia alba~     (Mill.) N. E. Brown, an herb with many effects on central nervous system, on pain frequency~     and intensity of migraine patients.~      Methods: Patients were enrolled in a prospective, phase 2, non-controlled cohort study to~     orally receive ethanolic extract of L. alba leaves (1-2 drips/kg/day). Headache intensity and~     frequency of episodes were recorded before and after 30-60 days of treatment. The~     investigators also studied the chemical composition of its essential oil by gas~     chromatography-mass spectrometry.~      Results: The investigators described for the first time a particular L. alba chemotype with~     geranial and carvenone as major compounds. With treatment, both frequency and intensity of~     pain episodes significantly decreased from baseline to first reassessment date. More than 80%~     of patients experienced a minimum 50% reduction on pain intensity and frequency. No side~     effects were reported.~      Conclusions: Treatment with a geranial plus carvenone chemotype of L. alba ethanolic extract~     is a cheap, widely available, highly effective therapy to reduce both the intensity and the~     frequency of headache episodes of migraine patients with no side effects.~      Keywords: headache, migraine, medicinal plant, essential oil, phytotherapy~   "
176116|NCT01259934|"~     The aim of this study is to evaluate the effect of giving adjuvant treatment with~     intermediate doses of interferon-alpha2b to patients operated for high risk melanoma.~     Patients are randomly assigned to either observation only or interferon treatment for 2~     different durations. The outcome with respect to overall survival, relapse-free survival,~     side effects and quality of life is analysed.~   "
176117|NCT01259921|"~     The purpose of this study is to determine whether neurofeedback (NF) training can~     significantly reduce the symptoms of Posttraumatic Stress Disorder (PTSD) in individuals with~     significant affect dysregulation and chronic, treatment-resistant PTSD. The primary aims of~     this study include:~        1. To examine whether NF has the potential to significantly reduce symptoms of PTSD.~        2. To examine whether NF training can specifically target the area of affect regulation.~        3. To examine the mechanism of NF through elucidating the relationship between affect~          regulation and PTSD symptom change.~   "
176118|NCT01259908|"~     Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally~     laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be~     followed up and the results will be compared between the two procedures on the basis of the~     primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity,~     graft thrombosis and all-cause mortality.~   "
176119|NCT01259895|"~     The purpose of this study is to determine the effect of different time of sleep restriction~     on control of food intake and metabolism of obese and normal subjects.~   "
176120|NCT01259882|"~     This is a two part study. The purpose of the first part is primarily to determine the safety~     and toleration and pharmacokinetics of PF-05089771 following single escalating doses.~     Secondary objectives will be to investigate the PK of an alternative formulation of~     PF-05089771 and the effect of food on the PK of PF-05089771. The second part of the study~     will focus on investigation of the exploratory pharmacodynamics of PF-05089771 using novel~     biomarkers in healthy volunteers. The doses selected in Part B will have been administered~     previously in Part A of the study.~   "
176121|NCT01259869|"~     The purpose of this study is to find out whether the new drug PX-866 will slow the growth of~     your glioblastoma multiforme.~   "
176122|NCT01259856|"~     This research is looking at two conditions, Essential Thrombocythemia (ET) and Polycythemia~     Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes~     too many platelets and red blood cells to be made. Platelets are particles which circulate in~     the blood stream and normally prevent bleeding and bruising. Having too many platelets in the~     blood increases the risk of developing blood clots, which can result in life threatening~     events like heart attacks and strokes. When the number of red blood cells is increased in PV~     this will slow the speed of blood flow in the body and increases the risk of developing blood~     clots.~      The purpose of this study is to look at the effectiveness of giving participants who have~     been diagnosed with ET or PV one of two different study regimens over time. The study subject~     will be followed for their condition for about 5 years. The subject will be randomized into~     one of two study regimens, either Pegylated Interferon Alfa-2a (PEGASYS) or Aspirin and~     Hydroxyurea (also called Hydroxycarbamide). The subject must be newly diagnosed or already~     receiving treatment for either PV or ET. Each of the study drugs used in this study is~     already being used to treat subjects with ET or PV currently, but the investigators are~     unsure which study drug is better.~   "
176123|NCT01259843|"~     The study examined the clinical characteristics and conditions of care for patients with~     acute aortic syndrome (AAS) that will identify patients at risk for increased morbidity and~     mortality and provide a basis for the eventual achievement of specific studies on the optimal~     therapeutic management according to different risk profiles. The aim of the Observatory is to~     provide a photograph size of practices in France at present, both in the larger centers~     than in smaller and optimize diagnostic and therapeutic currently available by the activation~     pathways of rational management.~   "
176124|NCT01259830|"~     Post-operative pain after laparoscopic colon and rectal surgery in fast-track design.~      A fast-track program is an evidence-based, multimodal approach for patients undergoing~     surgery to reduce perioperative morbidity, hospital stay and cost and to increase patient~     centered well-being. Optimized pain relief is a core component of any fast-track regimen.~      In this context epidural analgesia has become the standard of care for early postoperative~     pain therapy.~      However, it is debated whether non-opioid analgesics should be given as adjuncts when~     epidural analgesia is already present.~      The purpose of this study is to demonstrate that the administration of etoricoxib 120mg~     additionally to the clinical routine therapy (epidural catheter) reduces the post-operative~     pain level during movement after laparoscopic colon surgery in the fast-track design.~   "
176172|NCT01259193|"~     Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with~     antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.~      Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer.~     Emerging data suggest that zoledronic acid may also exhibit anticancer properties.~      The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic~     Acid and to evaluate overall survival and time to progression.~   "
176125|NCT01259817|"~     The aim of this research is to look at two conditions, Essential Thrombocythemia (ET) and~     Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and~     PV causes too many platelets and red blood cells to be made. Platelets are particles which~     circulate in the blood stream and normally prevent bleeding and bruising. Having too many~     platelets in the blood increases the risk of developing blood clots, which can result in life~     threatening events like heart attacks and strokes. When the number of red blood cells is~     increased in PV this will slow the speed of blood flow in the body and increases the risk of~     developing blood clots.~      It is important for patients with ET or PV who are at risk of blood clots to receive drugs~     which will minimize the risks of developing these blood clots but at the moment the~     investigators are not sure which drugs will best control the disorder.~      The purpose of this study is to look at the effectiveness of giving patients who have been~     diagnosed with ET and PV a study drug regimen using Aspirin and PEGASYS (also known as~     Pegylated interferon alfa-2a, instead of the standard treatment drug called Hydroxyurea (or~     hydroxycarbamide or Hydroxyurea), for whom this drug may not be suitable. The drug may not be~     suitable either because it is not adequately controlling the number of blood cells or some~     specific side effects occur.~   "
176126|NCT01259804|"~     Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy~   "
176127|NCT01259791|"~     This study consists of a series of prospective, randomized placebo-controlled n of 1 trials~     to objectively evaluate the reproducibility of subjective and objective symptoms among~     patients with a history of statin-related myopathy.~   "
176128|NCT01259778|"~     This is a National, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth~     hormone treatment from hospital in Korea in order to assess the level of adherence of~     subjects receiving SAIZEN® via easypod™.~   "
176129|NCT01259765|"~     The investigators hypothesize that :~      oral administration of VHH batch 203027 will be~        -  safe and tolerable for healthy Bangladeshi humans of all age groups (Part I)~        -  effective in reducing severity of diarrhoea in children with proven rotavirus infection~          (Part II). This entry only covers Part II.~   "
176130|NCT01259752|"~     This is a multicenter prospective randomized superiority controlled trial comparing leg~     stockings and standard care to standard care of ankle sprain and testing the hypothesis that~     compression stockings enable to reduce the median of recovery from ankle sprain by at least 6~     days.~   "
176131|NCT01259739|"~     The purpose of this study is to characterize the potential improvement of cocoa flavanols on~     exercise capacity in highly trained cyclist. A placebo-controlled double-blinded randomized~     control study will be performed in 13 highly trained cyclist (crossover design). Participants~     will perform a baseline exercise testing on an ergometer. They will receive either a~     flavanol-poor or flavanol rich cocoa drink twice daily for one week before a second and third~     exercise testing is performed. The order of drinks is randomized and balanced~     (high-flavanol-->low-flavanol drink or low-flavanol drink-->high-flavanol drink)~   "
176132|NCT01259726|"~     The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621~     dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the~     frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to~     evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a~     dose regimen of VP 20621 to be used in future studies.~   "
176133|NCT01259713|"~     The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®)~     can reduce the incidence of invasive fungal infections (IFIs) in patients with Acute~     Lymphoblastic Leukemia (ALL) who are undergoing their first remission induction.~   "
176134|NCT01259700|"~     Cardiovascular disease is the leading cause of death in China. At the village level,~     strategies for the control of cardiovascular disease are mostly absent. National clinical~     guidelines for the management of hypertension and cardiovascular disease are rarely~     disseminated to, or implemented by, the village primary care providers. Salt reduction has~     greater potential in rural China than almost anywhere else in the world. Very high levels of~     salt consumption, very little use of processed food and most dietary salt deriving from home~     cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in~     almost any other setting. The two large-scale cluster-randomized controlled trials proposed~     here will precisely and reliably define the effect of two highly plausible intervention~     strategies on important clinical outcomes. The evidence provided by the project will form the~     basis for policy setting that has the potential to greatly reduce the occurrence of vascular~     disease in rural China and take an important step towards balancing the rural urban divide in~     health and healthcare.~   "
176135|NCT01259687|"~     Pulse transit time (PuTT) - the time between R wave on ECG and initiation of upstroke in the~     peripheral arterial waveform - described in the previous studies as value that reflects~     changes in both blood pressure and blood volume. The investigators are assuming that PuTT~     changes reflect the dynamic of systolic blood pressure but not cardiac output fluctuations.~   "
176136|NCT01259674|"~     The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute~     cough as compared to a placebo syrup.~   "
176151|NCT01259479|"~     Background:~        -  Cisplatin and carboplatin are standard cancer treatment drugs used for various childhood~          cancers, including brain tumors. Both drugs frequently have severe side effects that may~          reduce their effectiveness, particularly in children, and new treatments are needed that~          may be similarly effective but less toxic for cancer patients.~        -  Satraplatin is an experimental drug, similar to cisplatin and carboplatin, that has not~          yet been approved by the Food and Drug Administration. Satraplatin has been shown to~          treat cancer by interfering with genetic material (DNA) in cancer cells. Some adults~          with cancer who have received satraplatin had slowing of the growth or shrinkage of~          their tumor. Researchers are interested in determining whether satraplatin can be~          effective for cancers that occur in children.~      Objectives:~        -  To evaluate the safety and effectiveness of satraplatin as a treatment for children and~          young adults who have solid tumors that have not responded to standard treatment.~        -  To study the effects of satraplatin on the body in terms of side effects and blood~          chemistry.~        -  To examine the effect that genetic variations may have on the effectiveness of~          satraplatin.~      Eligibility:~      - Children, adolescents, and young adults between 3 and 21 years of age who have solid tumors~     (including brain tumors) that have not responded to standard treatment.~      Design:~        -  Participants will be screened with a full physical examination and medical history,~          blood tests, and tumor imaging studies.~        -  Participants will receive satraplatin pills to be taken every day in the morning for 5~          consecutive days, with no food for 2 hours before or 1 hour after the dose. Participants~          will then have 23 days without the drug to complete a 28-day cycle of treatment.~          Participants will also receive medication to prevent nausea and vomiting 30 minutes~          before the first dose of satraplatin. Following the first dose of satraplatin,~          medication for nausea will be given if needed.~        -  Satraplatin doses will be adjusted based on response to treatment, including potential~          side effects. Participants will have frequent blood tests and imaging studies to~          evaluate the effectiveness of the treatment and monitor any side effects, as well as~          hearing tests and other examinations as required by the study researchers.~        -  Participants will receive satraplatin every 4 weeks for up to 2 years until serious side~          effects occur or the tumor stops responding to treatment.~   "
176137|NCT01259661|"~     Hormonal changes associated with menopause, chronological aging, and lifestyle, especially~     physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women.~     Women exhibiting the metabolic syndrome have multiple coronary artery disease risk factors,~     including insulin resistance, hyperlipidemia, and hypertension. This study will be conducted~     to test the hypotheses: (1) physical activity and physical fitness levels may have effects on~     individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance~     exercise training may have a favorable effect on components of the metabolic risk variables~     in these women.~      In this study, the associations among physical activity (including daily energy expenditure~     and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level,~     and metabolic risk profile of the women will be assessed. The investigators will perform a~     randomized trial to compare the effects of moderate-intensity aerobic exercise training~     regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk factor~     for metabolic syndrome will be randomized in the exercise group or control groups. Metabolic~     risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure,~     lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study.~     Differences from baseline to follow-up will be calculated and compared across groups.~      Results of this study may help health care providers providing advice to postmenopausal women~     for life style changes to reduce risk of insulin resistance, coronary heart disease, and~     diabetes.~   "
176138|NCT01259648|"~     The primary objective is to determine whether, during a rapid sequence intubation by~     etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2~     different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous~     reactional tachycardia.~   "
176139|NCT01259635|"~     The freezing burden will be quantified in subjects with Parkinson's Disease (PD)before and~     after 6 weeks of training. Two types of interventions (20 subjects in each group) will be~     tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG~     training includes walking courses aimed at provoking freezing episodes. The experimenter will~     trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke~     freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the~     auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid~     freezing. Similar principles will apply for the CLG training; however, the RAS will be~     elicited automatically by a device that recognizes an approaching freezing episode.~   "
176140|NCT01259622|"~     The purpose of this study is to evaluate the effects of a single intravenous infusion of K201~     compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of~     subject's symptom score, and safety.~   "
176141|NCT01259609|"~     The purpose of this study is to determine whether ciliary body thickness increased in the~     presence of diabetic macular edema and whether it changed after pars plana vitrectomy.~   "
176142|NCT01259596|"~     The purpose of this study is to determine if cognitive-behavioral therapy (CBT)and supportive~     therapy delivered by telephone are effective for reducing worry and anxiety in rural older~     adults with Generalized Anxiety Disorder (GAD).~   "
176143|NCT01259583|"~     Due to the increasing demand for colonoscopy in clinical practice, great interest has~     recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm~     Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as~     compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance~     of the above techniques versus AI in unsedated patients.~   "
176144|NCT01259570|"~     The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in~     absence of fat.~      As a model the investigators have chosen nonfat yoghurt. The investigators will prepare~     yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ;~     (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into~     skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched~     skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr~     yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by~     CMIA. In vitro simulated digestion will be studied.~      Expected results: The BA of VD in CM would not be lower than in fat~   "
176145|NCT01259557|"~     The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the~     treatment of Essential blepharospasm.~   "
176146|NCT01259544|"~     13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine~     function in patients with Chronic Pancreatitis.~   "
176147|NCT01259531|"~     This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week~     treatment of patients with severe urinary disorders associated with benign prostatic~     hyperplasia (BPH).~   "
176148|NCT01259518|"~     This is an open-label, parallel-group, two-center, safety, activity and pharmacokinetic study~     of TriN 2755 given at increasing dose levels as intravenous infusions administered over 4~     hours. The study is divided into two parts: Part I a dose escalation phase and Part II an~     extension phase.~   "
176149|NCT01259505|"~     The purpose of this study is to evaluate the safety of HLA-A*2402 restricted epitope peptides~     CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 emulsified with Montanide ISA 51.~   "
176150|NCT01259492|"~     This study will evaluate efficacy and safety of methylphenidate hydrochloride extended~     release compared to placebo in adult patients with childhood-onset attention~     deficit/hyperactivity disorder (ADHD).~   "
176165|NCT01259297|"~     This study was planned to provide new information regarding the role of aliskiren (with or~     without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly~     individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing~     major cardiovascular (CV) events and on global measures of physical, executive and cognitive~     function.~   "
176166|NCT01259284|"~     The goal of this clinical research study is to learn if Lipitor (atorvastatin) or fish oil~     supplements can help to control side effects of the heart that are commonly seen after lung~     surgery (such as irregular heartbeat). Researchers also want to learn if one of these drugs~     is more effective than the other at controlling side effects.~   "
176173|NCT01259180|"~     The purpose of ths study is to determine the efficacy of acupuncture on chronic pelvic pain~     in women with endometriosis or adenomyosis.~   "
176152|NCT01259466|"~     This project will be a randomized clinical trial testing the efficacy of an~     internet-administered smoking cessation treatment for overweight and obese smokers. Research~     on internet-administered behavioral treatments for smoking cessation has found that compared~     to control treatments (e.g., self-help materials), cessation rates in internet-administered~     treatments are significantly higher. Research testing the applicability of these treatments~     to overweight and obese individuals has not yet been conducted. Given that a substantial~     portion of smokers are also overweight and at elevated cardiovascular risk, there is a need~     for directed treatment efforts for this group. The current trial proposes to be the first to~     test the effectiveness of internet-administered smoking cessation treatment for overweight~     and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of~     internet-administered treatment consisting of either: a) standard smoking cessation treatment~     with general health education, or b) standard smoking cessation treatment with cognitive~     behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive~     open-label treatment with the 21 mg transdermal nicotine patch.~   "
176153|NCT01259453|"~     The investigators seek to provide immunization for individuals who are at high risk of~     contracting hepatitis B virus (HBV) infection because of their illicit drug use. The~     investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport,~     CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The~     primary purpose of the study is to compare the standard schedule of hepatitis B vaccination~     at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The~     investigators hypothesize that the accelerated scheduling will result in improved completion~     rates without significant loss in vaccine efficacy.~   "
176154|NCT01259440|"~     Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk~     factors of male gender, being overweight, and increasing age. OSA is caused by upper airway~     obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway~     pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is~     suboptimal. Because research shows that adherence patterns are established early in~     treatment, we seek to use a technology that enables early and frequent productive~     interactions between patient and provider.~   "
176155|NCT01259427|"~     The purpose of this study is to determine if Ending Self-Stigma (ESS), a 9-session group~     intervention designed to assist veterans with serious mental illness to develop skills (SMI)~     to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and~     stereotypes, is more effective in reducing internalized stigma and its associated effects~     than an active comparison group.~   "
176156|NCT01259414|"~     TACE is considered the standard treatment for unresectable HCC and is widely used as a~     palliative treatment. However there is no consensus of the protocol of TACE.One of the~     variation is does the stability of the suspension by emulsified the lipiodol and the contrast~     medium used to dissolve the anticancer agents really effect the survival.Thus the~     investigators conduct this prospective,randomized controlled study to find out if the~     different method of preparing chemotheraputic drugs can cause a different survival benefit.~   "
176157|NCT01259401|"~     The Veterans Millennium Health Care and Benefits Act (Millennium Act) of 1999 mandated the~     Department of Veterans Affairs (VA) to provide non-institutional long-term care to veterans.~     Adult Day Health Care (ADHC) is a key component of that spectrum of long-term care services.~     Veterans in ADHC commonly suffer from limited poor functioning, depression, cognitive~     problems and low quality of life. These factors can lead to continued deterioration in~     functioning, loss of independence, hospitalizations, nursing home placement and death. Sleep~     disruption is associated with depression, low quality of life, functional decline, nursing~     home placement, and death among older people. Sleep disturbance is common among ADHC~     patients, it is not addressed within routine clinical care, and treatment may be limited to~     medications. Studies show that untreated insomnia and medications for insomnia can increase~     risk of falls and other health events among older persons. On the other hand, non-medication~     treatments for sleep do not show these problems. These treatments have been shown to be~     effective in other studies. The goal of this study is to test non-medication treatments to~     improve sleep among older Veterans with insomnia in a VA ADHC program. The study design will~     facilitate translation into routine care and application in other similar VA programs.~   "
176158|NCT01259388|"~     The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated,~     and effective at treating progressive forms of multiple sclerosis.~   "
176159|NCT01259375|"~     Primary Objectives~        1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced~          sarcoma as first line therapy.~        2. To evaluate Progression Free Survival (PFS).~      Secondary Objectives~        1. To assess the safety and tolerability of amrubicin in this patient population.~        2. To evaluate whether certain histologic subtypes of sarcoma demonstrate a differential~          response to amrubicin.~        3. To investigate quality of response with radiographic evaluation using both Response~          Evaluation Criteria In Solid Tumors (RECIST) and Choi criteria.~        4. To evaluate overall survival (OS).~   "
176160|NCT01259362|"~     Cocaine addiction is a serious disease. Nowadays we still have no efficient method reducing~     craving and extending the abstinence period of this patients during treatment.~      The aim of this study is to evaluate reduction if craving and other parameters related to~     addiction within this group of patients through a treatment with transcranial magnetic~     stimulation.~   "
176161|NCT01259349|"~     Coaxial microincision cataract surgery using 1% ultrasound is not inferior to standard~     coaxial microincision cataract surgery in patients of grade 0.1-6.0 immature senile cataract~     in terms of corneal endothelial safety.~   "
176162|NCT01259336|"~     The purpose of this study is to determine whether there itraconazole is effective in the~     treatment of chronic cavitary pulmonary aspergillosis~   "
176163|NCT01259323|"~     The purpose of this study is to assess the Safety and Tolerability of REGN668 (how the body~     reacts to the drug) compared to placebo (an inert substance) in patients with~     moderate-to-severe extrinsic Atopic Dermatitis.~   "
176164|NCT01259310|"~     This is a three-center prospective case-control study to examine the patterns of fertility~     among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy~     (WWoE).~   "
176182|NCT01259063|"~     The purpose of this study is to test the safety of gemcitabine applied to the bladder~     directly combined with different oral doses of everolimus and to assess the right doses.~     Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be~     evaluated. The purpose of the phase II part is to test the combination of gemcitabine applied~     to the bladder directly combined with different oral doses of everolimus and to study the~     effects of these two drugs together. The investigators want to find out what effects, good~     and/or bad, this treatment has on the patient and the cancer.~   "
176183|NCT01259050|"~     The purpose of this study is to determine the safety of Zinc given at 90mg/d in conjunction~     with 2mg/d of copper in ALS patients.~   "
176184|NCT01259037|"~     This study will look at high frequency ultrasound as a medical imaging modality and apply it~     to skin lesions. Elastography is an ultrasonic method of looking at the hardness of an area.~     We will use this to try and differentiate between benign and cancerous skin lesions.~   "
176185|NCT01259024|"~     This study involves the combined use of the FDA approved device, LC Bead and the FDA approved~     drug, Doxorubicin for the treatment of primary hepatocellular carcinoma (HCC). The current~     indication of the LC Bead is for the embolization of hypervascular tumors and arteriovenous~     malformations. The study is designed to establish if drug eluting beads are more effective~     and less toxic than standard chemoembolization treatment.~   "
176186|NCT01259011|"~     The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness~     Representations to Increase Trust) intervention designed to improve discussions about~     end-of-life care between patients and their surrogate decision makers. Subjects will be 200~     Caucasian and African-American patients with ESRD (end-stage renal disease) recruited from~     outpatient dialysis clinics and their chosen surrogate decision makers. We hypothesize that~     (1) SPIRIT will lead to significantly less patient decisional conflict and significantly~     greater dyad congruence and surrogate decision making confidence than the standard care~     control at 2, 6, and 12 months post-intervention and (2) SPIRIT will reduce surrogate~     decisional conflict and psychosocial morbidities at 2 weeks after the patient's~     hospitalization requiring surrogate decision making significantly more than the standard care~     control.~   "
176187|NCT01258998|"~     This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients~     with relapsed lymphoma. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
176188|NCT01258985|"~     We will conduct a large randomized controlled trial comparing the effectiveness and~     cost-effectiveness of Tai Chi mind-body exercise and standard-of-care Physical Therapy for~     Knee Osteoarthritis.~   "
176189|NCT01258972|"~     The Tryton Side Branch Stent System has been designed to address the procedural difficulty~     surrounding treatment of bifurcation lesions and to ensure patency of the side branch with~     similar performance capabilities (e.g., tracking, radiopacity, coverage and radial strength)~     that are currently available with conventional coronary stents designed for straight (non~     bifurcation) lesions.~      The Tryton Side Branch Stent is intended to treat and maintain patency in the side~     branch/carina by providing better ostial side branch conformability and is intended for use~     in conjunction with currently approved balloon-expandable drug-eluding stents for treatment~     of the main branch.~   "
176190|NCT01258959|"~     Ophthalmic surgery on the posterior section of the eye can either be performed under general~     anaesthesia or under local aneasthesia. The local anaesthesia is performed by injecting local~     anaesthetics behind the eye. There are two techniques: Either the needle is placed into the~     muscle cone formed by the four recti muscles - this is called intraconal or retrobulbar~     block, or the needle is placed outside of the muscle cone - this would be called extraconal~     or peribulbar. In our hospital the investigators usually perform the peribulbar block since~     it is easier to perform and has a smaller risk to injure the eye. The investigators however~     realize that the parabulbar block is sometimes very efficient and sometimes not, thus~     requiring a second or third injection. Now investigators are able to visualize where the~     local anaesthetics spreads with the help of ultrasound imaging. The aim of the study is to~     observe and to describe the incidence of intraconal spread of local anaesthetics when a~     peribulbar block is performed.~   "
176191|NCT01258946|"~     The aim of the present study was to search whether epicardial adipose tissue thickness, a~     predictor of increased cardiovascular risk, increases in PCOS patients or not and, if it~     does, to analyze the relationship of EATT with insulin resistance, adiponectin and~     biochemical and anthropometric parameters.~   "
176192|NCT01258933|"~     The goal of this clinical research study is to find out if ofatumumab can control CLL or SLL~     that is left after chemotherapy or chemoimmunotherapy. The safety of the drug will also be~     studied.~   "
176193|NCT01258920|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     paliperidone palmitate in Japanese patients with schizophrenia. Secondary objectives of this~     study are to: explore the efficacy on symptoms of schizophrenia and the maintenance of~     treatment effect; explore the pharmacokinetics of paliperidone palmitate through sparse~     pharmacokinetic sampling.~   "
176194|NCT01258907|"~     This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized,~     multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care~     therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as~     quantified by FDG-PET/CT.~   "
176195|NCT01258894|"~     Studies revealed that patients with hereditary persistence of AFP also had persistent~     abnormal AFP. Therefore, this study will recruit the patients and their family with elevated~     AFP (>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted~     from the blood will be analyzed.~   "
176196|NCT01258881|"~     Ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate among~     the gynecologic malignancies. The majority of patients with epithelial ovarian carcinoma are~     diagnosed at advanced stage which has the overall survival rates of only 19-30%. As the~     advance in the managements which prolonged the overall survival, metastatic lesion in rare~     location such as brain was noted in few patients of ovarian cancer in recent years. In the~     retrospective study, the investigators will review the medical records of the ovarian cancer~     patients with brain metastasis in the investigators hospital to investigate the incidence,~     clinical courses, optimal managements and possible prognostic factors in the rare condition.~   "
176197|NCT01258868|"~     Background:~      - Recent research has shown that causing an immune response to tumor cells may help slow or~     stop the growth of tumors. One treatment that has come from this research involves collecting~     and modifying a cancer patient's tumor cells in the laboratory, then returning the cells to~     the patient as a vaccine to encourage the immune system to respond to them. Researchers are~     interested in testing tumor cell vaccines with an experimental drug called ISCOMATRIX , which~     can be added to a vaccine in order to elicit a stronger immune response in the body.~     ISCOMATRIX has not been approved for sale and use in any country and its use is still~     experimental, though it has been tested and used safely in other clinical studies.~     Researchers are also interested in determining whether the anti-inflammatory drug celecoxib~     will improve the body's immune reaction if given with the vaccine.~      Objectives:~      - To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and~     celecoxib in the treatment of lung and esophagus cancers.~      Eligibility:~        -  Individuals at least 18 years of age who have primary small cell or non-small cell lung~          cancer, esophageal cancer, or pleural mesothelioma that can be removed by surgery.~        -  Only individuals whose tumor cells are able to produce a tumor cell line for vaccine~          development will be eligible for treatment.~      Design:~        -  Participants will be screened with a physical examination and medical history, and will~          have tumor tissue collected during their surgery to determine whether the tumor cells~          can be used to produce a vaccine.~        -  Participants will take celecoxib twice daily for 7 days before having the first tumor~          cell vaccination. Participants will also have leukapheresis to collect blood cells for~          testing before the first vaccination.~        -  Participants will receive one vaccine (which may be given in two shots) monthly for 6~          months, and will continue to take celecoxib twice daily. One month after the 6th vaccine~          shot, participants will have another leukapheresis and skin test. If these tests show~          that a participant is responding to the vaccine, additional vaccines will be given every~          3 months for up to 2 years.~        -  Participants will have a physical exam and lab tests before each vaccination, blood~          samples and imaging studies every 3 months, and a skin test every 6 months.~        -  Participants will have regular followup visits with imaging studies and blood samples~          for up to 5 years after the first vaccination, or until a new tumor develops....~   "
176198|NCT01258855|"~     This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept~     works in treating patients with stage III-IV melanoma that cannot be removed by surgery.~     Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the~     growth of melanoma by blocking blood flow to the tumor. It is not yet known whether~     aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.~   "
176199|NCT01258842|"~     To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of~     developing physician- and laboratory-confirmed influenza infection at any time during the~     12-week supplementation period.~   "
176200|NCT01258829|"~     Many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for~     heart failure do not have the settings of their device optimised. The most widely available~     method for optimisation uses flow measured using cardiac ultrasound (echocardiography) to~     determine the optimal settings. However, this is not frequently performed because it is time~     consuming and requires two skilled operators. In this study the investigators will test a new~     non-invasive method for optimisation, which utilises pressure measurements (non-invasive~     blood pressure measured from the finger).~      Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms~     of exercise capacity, to conventional echo optimisation.~   "
176201|NCT01258816|"~     The purpose of the study is to investigate the pharmacokinetics (PK) and cardiac properties~     of elacytarabine in patients with relapsed or refractory Acute Myeloid Leukaemia (AML). The~     efficacy and tolerability of elacytarabine will also be assessed.~   "
176202|NCT01258803|"~     A study to compare the bronchodilatory effect of a single dose of Mometasone~     Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and~     without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus~     Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder inhaler~     (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each participant~     was to receive a single dose of each of 4 treatments in each period. Each treatment period~     was separated by a 5 to 7 day washout period. It assumed that a single dose MF/F MDI 100/10~     microgram (mcg) delivered with a spacer would produce bronchodilation, defined as a~     significant increase in forced expiratory volume in one second (FEV1) area under the curve~     from 0 to 12 hours (AUC[0-12 hr]) when compared to placebo.~   "
176203|NCT01258790|"~     Specific Aim1: Using a paradigm of Transcranial Magnetic Stimulation called Continuous Theta~     Burst Stimulation (cTBS) to reduce tics in Tourette Syndrome subjects~      Hypothesis1: cTBS, compared to sham stimulation, will reduce tic severity by at least 25% as~     measured by the Yale Global Tic Severity Scale~      Specific Aim2: Using cTBS to further understand neural correlates of tic generation~      Hypothesis2: Functional MRI BOLD signal activation pattern will change after cTBS and this~     change will correlate with clinical improvement in tic severity~   "
176204|NCT01258777|"~     The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and~     Caucasian Males.~   "
176205|NCT01258764|"~     The purpose of this trial is to evaluate if an objective clinical decision of~     anti-hypertensive therapy can be made using an N-of-1 (single patient) trial design.~   "
176206|NCT01258751|"~     The purpose of this study is to evaluate the relationship between plasma drug levels and~     receptor binding in brain using PET; and to evaluate safety and tolerability after a single~     administration of PF-05212377 in healthy volunteers~   "
176207|NCT01258738|"~     This is a two part study. During period one there will be a comparison of Etanercept (ETN)~     against a placebo with both arms maintaining the background anti inflammatory drug prescribed~     by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as~     determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis~     (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone~     in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory~     drug(NSAID).~   "
176208|NCT01258725|"~     The aim of this study is to compare the uteroplacental and pulmonary circulation of the~     fetuses with severe (AFI<5cm) idiopathic oligohydramnios (with unknown origin) to those in~     normal controls. Further purpose of the study is to measure the changes of the uteroplacental~     and fetal pulmonary circulation in patients presenting with severe idiopathic~     oligohydramnios, managed either with single amnioinfusion or with serial amnioinfusions.~   "
176209|NCT01258712|"~     This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with~     Rheumatoid Arthritis.~   "
176210|NCT01258699|"~     This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab~     600mg in Healthy Adult Male Subjects.~   "
176211|NCT01258686|"~     The purpose of this study is to determine the effectiveness of silymarin 700 mg thrice daily~     and assess the safety in patients with hepatitis C virus infection compared to a placebo.~   "
176212|NCT01258673|"~     The purpose of this study is to evaluate the antihypertensive efficacy and safety of~     Fimasartan/Hydrochlorothiazide combination 60/12.5mg~120/12.5mg in patients with essential~     hypertension who are not controlled by fimasartan 60mg.~   "
176213|NCT01258660|"~     The purpose of this study is to examine and compare the uptake of levomefolate calcium~     (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of~     treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking~     contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was~     co-administered over the entire period of 44 weeks.~   "
176214|NCT01258647|"~     Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer~     from stunting of linear growth by 12 months of age. Stunting presumably results from breast~     milk supplementation after 6 months of age with complementary foods (CF) that provide~     inadequate protein and micronutrients. Although supplementation with selected micronutrients~     may avoid certain deficiency states, CF with animal source foods may be necessary to avoid~     stunting. Meat is not readily available in many Central African countries. However~     caterpillars, which are locally available and abundant, are a common staple in adult diets~     and may be a suitable substitute for animal source proteins in CF. The investigators~     developed a cereal made from dried caterpillars that has a nutrient content that appears to~     be ideal for CF. Maternal and infant acceptability will be evaluated in 20 mothers and their~     8 month old infants. The investigators hypothesize that this cereal will be accepted by both~     mothers and infants: acceptability will be based on a priori definitions.~   "
176215|NCT01258634|"~     This is a pilot study that will allow investigators to collect data related to early and~     potentially more accurate response assessments using a chemotherapy protocol that eliminates~     methotrexate to maximize the dose intensity of doxorubicin. The pilot data will be used to~     seek funding to more fully address the hypotheses in a multi-institutional, Phase II or Phase~     III trial. The primary and secondary objectives are as follows:~      Primary:~        1. To evaluate the feasibility and potential usefulness of measuring early changes in tumor~          metabolic activity, assessed by Fludeoxyglucose-Positron Emission Tomography (FDG-PET)~          imaging and alkaline phosphatase activity, as early predictors of histological response~          rate at 12 weeks in osteosarcoma patients.~        2. To explore whether histological response can be assessed by a computer algorithm using~          virtual microscopic images of pathology material, and whether quantifying necrosis in~          this way correlates with microscope slide-based review.~      Secondary:~      1. To gather pilot data on the histological response rate, 3-year event-free survival, and~     toxicity when children and young adults with resectable osteosarcoma are treated using a~     chemotherapy regimen of alternating courses of doxorubicin/cisplatin (DC) and~     doxorubicin/ifosfamide/etoposide (IDE).~      All patients will receive 4 courses of preoperative chemotherapy courses. With the exception~     of high-dose methotrexate, which is given weekly, preoperative and postoperative chemotherapy~     courses are planned to begin every 21 days.~      Patients with good histological response (those patients with > 90% tumor necrosis at time of~     definitive resection) will receive three postoperative chemotherapy courses. The 1st will~     consist of doxorubicin, dexrazoxane, cisplatin and Granulocyte-Colony Stimulating Factor~     (G-CSF)(or Polyethylene Glycol filgrastim). The 2nd course will consist of doxorubicin,~     dexrazoxane, ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastim). The 3rd course will~     consist of ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastrim). The total doxorubicin~     dose will be 450 mg/m2.~      Patients with poor response (those patients with < 90% tumor necrosis found on pathology at~     time of definitive resection) will receive five postoperative chemotherapy courses. High~     Dose-Methotrexate will be administered during the 1st and 3rd postoperative chemotherapy~     courses as 4-weekly and 2-weekly doses, respectively. The 2nd course will consist of~     doxorubicin, dexrazoxane, cisplatin and G-CSF (or PEG-filgrastim). The 4th course will~     consist of doxorubicin, dexrazoxane, ifosfamide, Mesna, etoposide, G-CSF (or PEG-filgrastim).~     The 5th cycle will consist of ifosfamide, Mesna, etoposide, G-CSF (or PEG-filgrastrim). The~     total doxorubicin dose will be 450 mg/m2.~   "
176216|NCT01258621|"~     Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has~     recently becoming the treatment of choice in experienced centres. No data have been published~     about learning curve so far. The purpose of this study was to identify the learning curve~     period for performing LDP.~   "
176217|NCT01258608|"~     Mapatumumab is a fully human, agonist monoclonal antibody that activates the cell death~     pathway in tumor cells by specifically binding to TRAIL-R1 with high affinity. Sorafenib, a~     multikinase inhibitor, is the standard of care for treatment of patients with advanced~     hepatocellular carcinoma (HCC). The mechanisms of sorafenib and mapatumumab action suggest~     that these agents could interact synergistically. This is a Phase 2, multi-center,~     randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of~     mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma.~   "
176218|NCT01258595|"~     The aim of the study is to generate data on key parameters associated with assessment of~     influenza vaccines in individuals 50-64 years of age~      Primary Objective:~        -  To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine~          (TIV) compared to TIV.~        -  To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as~          assessed by solicited adverse reactions collected for 7 days post-vaccination, and~          unsolicited adverse events (including Serious Adverse Events and Adverse Events of~          Special Interests) collected between Visit 1 and Visit 2~   "
176219|NCT01258582|"~     This study was initially designed to compare the effectiveness of two different approaches to~     providing routine HIV counseling, testing, and referral services in an urban hospital~     emergency department setting. The initial phase was closed in July 2008. The second phase of~     this trial consists of establishing the differences in acceptability of HIV testing based on~     the method of testing offered (rapid oral fluid vs. fingerstick).~   "
176220|NCT01258569|"~     Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been~     shown to increase postoperative bowel function in patients after open bowel resection~     surgery. It has been proven safe and effective for short-term in-house treatment. At the~     present there are several Drug Use Utilization Evaluation studies reporting results involving~     the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However, this study~     will be the first randomized, prospective, double-blind, placebo-controlled trial looking at~     this population. We propose that Entereg will decrease the length of stay by one day in the~     laparoscopic colon resection patient. We wish to perform a voluntary, double-blinded, placebo~     controlled study. We plan an enrollment population of 250 patients. Twelve milligrams of~     Entereg will be administered 30 minutes to 5 hours pre-op followed by 12 mg BID, up to 7 days~     or 15 total doses. The primary endpoint of the study will be length of stay. The time of GI-2~     recovery (toleration of solid food and first bowel movement) and time to GI-3 recovery~     (toleration of solid food, and flatus or bowel movement) will be secondary endpoints.~      Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion Date:~     May 2012, Estimated Primary Completion Date: Nov 2011.~   "
176221|NCT01258556|"~     Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented~     with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women~     living with HIV.~   "
176222|NCT01258543|"~     The purpose of this study is to determine whether two osteopathic evaluators with less than 5~     years experience will be able to determine the same location and nature of the primary~     lesion(s) or restriction(s)in patients with chronic non-specific back pain using a global~     osteopathic evaluation approach.~   "
176225|NCT01258504|"~     The aim of the present study is to assess the impact of the cytochrome P450 2C9 (CYP2C9)~     genotype (*2 and *3 allele versus wild type; ~3-5% poor metabolisers in Caucasian population)~     on the pharmacokinetics of bosentan and the impact of CYP3A4-induction by St. John's wort~     (SJW) on steady state bosentan which is a CYP3A4 inducer itself.~   "
176226|NCT01258491|"~     The study will be a double-blind, randomized, placebo-controlled, single-center, 2~     treatment,3-way crossover to investigate the pharmacodynamics, i.e. the flush-symptom of a~     single oral repeated dose of 500 mg nicotinic acid in healthy subjects. Subjects will be~     randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:~        -  Treatment A: 500 mg nicotinic acid~        -  Treatment B: Placebo~   "
176227|NCT01258478|"~     Patients suffering from non small cell lung cancer(NSCLC), depend upon lung removal to~     increase their chances of survival. But, this type of surgery cannot be advised to patients~     with significant heart disease, limited lung fuction or reduced physical fitness. Intensive~     physical training has been shown to increase aerobic fitness in healthy subjects.~      The purpose of this study is to determine the effect of a short term rehabilitation prior to~     surgery on the post-operative and physiological outcomes for patients undergoing this type of~     surgery.~   "
176228|NCT01258465|"~     The purpose of this research project was to systematically compare two widely used types of~     intervention programs for children with autism within a parent training model. In one~     condition, randomly assigned children were provided with an intervention that typically~     results in acquisition of expressive words in a large percentage of children diagnosed as~     having autism, using a well-documented manualized intervention focused on verbal expressive~     communication only (Pivotal Response Training, PRT). In the other condi¬tion, randomly~     assigned children received a widely used intervention on the same social communication~     functions using a well-documented manualized augmentative system of intervention (Picture~     Exchange Communica¬tion System, PECS) that has been reported to produce verbal and nonverbal~     communication in large percentages of children diagnosed with autism. Children in the two~     conditions were compared for development of verbal and nonverbal communication, changes in~     disruptive behavior, changes in symptoms of autism, and general adaptive behavior gains. In~     addition, parent satisfaction and stress measures were gathered in order to assess the~     effects of each intervention on family functioning.~   "
176229|NCT01258452|"~     To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption~     of CHF 5074 after single oral administration in young healthy male volunteers.~   "
176230|NCT01258439|"~     This is a research study into the effects of three drugs used to treat HIV infection. Some~     drugs used to treat HIV have been associated with changes in blood fats such as cholesterol~     that could be harmful over the long-term, because these blood fat changes have been~     associated with a small, increased risk of heart disease and stroke in some studies of adults~     with HIV. Now that HIV can be controlled for long periods in most patients, and because heart~     disease is one of the biggest causes of illness and death in the general population, it is~     important to develop new HIV treatments that control HIV effectively but do not cause~     abnormal blood fats.~      Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than~     ritonavir-boosted darunavir.~   "
176231|NCT01258426|"~     Recently, seslenium(Se) has known as important regulator in metabolic status, lipid profile,~     atherosclerosis progression. SEPP1(selenoprotein P1)is a secreted protein from mainly liver.~     This protein is used as an index of selenium nutritional status. The association between the~     concentration of SEPP1(selenoprotein P1) in normal glucose tolerance,impaired glucose~     tolerance, type 2 diabetes is still a matter of debate. This cross sectional study will~     evaluate whether glucose status is matter in SEPP1 level.~   "
176232|NCT01258413|"~     The purpose of this study is to determine whether laparoscopic radical hysterectomy for early~     cervical cancer will has decreased postoperative pain intensity compared to abdominal radical~     hysterectomy with similar postoperative complications and survival rates.~   "
176233|NCT01258387|"~     Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single~     intravenous administrations of GGF2 in patients with heart failure.~   "
176234|NCT01258374|"~     While 3-drug regimens remain standard of care, concerns exist regarding the safety of~     multi-drug regimens taken for a lifetime. Problems with nucleoside analogue therapy prompted~     successful trials with ritonavir (RTV) boosted PI monotherapy, however long term safety and~     efficacy of such regimens remains unknown. Clinical trials have shown Raltegravir (RAL) to~     have potent activity when patients have few active background drugs; it has a superior lipid~     profile compared with EFV and LPV/RTV. Darunavir/r (DRV) is a potent, well tolerated PI with~     few GI side effects and lipid disturbances and with a high genetic barrier. The investigators~     hypothesized that RAL/DRV would be a well tolerated and effective regimen for those patients~     who are failing nucleoside reverse transcriptase inhibitors based regimens, due to poor~     tolerability or resistance. The investigators also would like to explore the plasma~     pharmacokinetics of Raltegravir combined with Darunavir in a sub-group of 12 HIV-infected~     patients.~   "
176235|NCT01258361|"~     The primary objective of this study is to demonstrate that preoperative fasting does not~     increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg~     lift) in patients undergoing surgery.~   "
176236|NCT01258348|"~     The purpose of this study is to determine a safe dose of LY573636-sodium to be given in~     combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to~     determine any side effects that may be associated with LY573636-sodium and sunitinib~     combination in this patient population. The tumor response rate will also be assessed.~   "
176237|NCT01258335|"~     Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral~     omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD).~      Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD.~   "
176251|NCT01258153|"~     This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind,~     placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and~     safety of Nepadutant given at two oral doses once daily for seven days in comparison to~     placebo in the treatment of infantile colic.~   "
176406|NCT01256138|"~     Allogene MSCs transplantation will be performed in patients with chronic liver diseases~     through portal vein by ultrasound guiding and therapeutic effects including short-term~     effects and long-term follow-up will be compared and investigated.~   "
176238|NCT01258322|"~     1. Background:Cardiovascular disease (CVD) is the major cause of mortality in peritoneal~          dialysis (PD) patients, in whom it is partly attributable to a higher prevalence of~          dysmetabolism. Currently, few treatments are available with a proven effect on~          dyslipidemia, insulin resistance and inflammation in this patient group.~        2. Study design: Randomized, cross-over trial.~        3. Settings and Participants: Prevalent PD patients (＞20 years old, s-triglycerides ＞1.8~          mmol/L) who had never received glitazones were enrolled.~        4. Interventions: Participants were randomized to receive either oral pioglitazone (PIO; 15~          mg once daily) and no pioglitazone, both for 12 weeks and in random order, with a~          four-week wash out in between.~        5. Outcomes and measurements: The primary endpoint was change of serum triglyceride (TG)~          level during the PIO as compared to no PIO. Secondary endpoints included changes in~          other lipid levels, HOMA-IR, adipocytokines and CRP. Outcome effects were assessed using~          a GLM.~   "
176239|NCT01258309|"~     This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac~     tromethamine fixed dose combination ophthalmic solution compared with olopatadine~     hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.~   "
176240|NCT01258296|"~     The aim of this randomized, double-blind controlled trial is to determine the efficacy of~     transdermal fentanyl for the management of early postoperative pain in women undergoing~     mastectomy followed by immediate TRAM or DIEP flap reconstruction. We will examine whether~     the use of the fentanyl patch as a bridge between epidural and oral analgesia will improve~     overall pain relief compared to placebo patch. We further propose to study whether the~     fentanyl patch is associated with improved ability to sleep, patient satisfaction, and~     functional capacity at one week, and whether it is associated with different side effects~     than standard therapy without the patch. Following informed consent, patients will undergo~     mastectomy and reconstruction, and receive epidural fentanyl for initial postoperative~     analgesia. Patients will be randomized to active (25 mcg/hr Duragesic) or placebo patches on~     postoperative day three, and the epidural will be weaned over the next 12 hours. Pain~     intensity scores and relief from pain will be assessed every day while in the hospital and~     oral and IV opioid use recorded. Patients will be discharged to home with a supply of 2~     patches and oral medication, and will be asked to fill out a daily pain and medication log.~   "
176241|NCT01258283|"~     The main objective of this study is to determine among the patients included a subpopulation~     that does not need a defibrillator.~      This will be done by comparing the number of discordant segments (mismatch) between patients~     who have a severe arrhythmia (ventricular tachycardia or ventricular fibrillation) with~     appropriate electrical therapy within 3 years of monitoring and others. Mismatch in the~     definition of this objective is the usual definition: score 3.4 in I123-MIBG (Iodine 123~     metaiodobenzylguanidine) and PET at 0,1,2.~   "
176242|NCT01258270|"~     The objective of this study is to determine the safety and effectiveness of the AQUACEL® Ag~     Surgical Dressing (treatment group) as compared to prepackaged island wound dressings~     consisting of traditional tape and gauze (control group) for total hip and total knee~     arthroplasty.~   "
176243|NCT01258257|"~     The intention of the study is to investigate whether drainage of cerebral spinal fluid via a~     lumbar route (Tuohy-drain) will improve outcome after intracranial aneurysmal subarachnoid~     hemorrhage (SAH).~   "
176244|NCT01258244|"~     The quality of cardiopulmonary resuscitation (CPR) provided to patients with out-of-hospital~     cardiac arrest (OHCA) is often suboptimal. There now exist monitors/defibrillators that allow~     for the measurement and real time feedback of the quality of chest compressions and~     ventilations. In addition to giving the prehospital provider the benefit of real time CPR~     quality feedback via voice and visual cues, the CPR quality data acquired using these devices~     can be utilized as part of an on-going quality assurance/quality improvement program.~      The first objective of the proposed project is to quantify the quality of chest compressions~     and ventilations provided in the state of Arizona to patients with OHCA and to determine~     whether the quality of CPR is related to patient outcome from OHCA.~      A second objective of this project is to determine whether use of audiovisual feedback~     improves both CPR quality and patient outcome in the pre-hospital setting.~   "
176245|NCT01258231|"~     This study aims to identify genetic causes of adverse events after cardiac surgery, such as~     atrial fibrillation, myocardial infarction, renal dysfunction and heart failure.~      Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute~     are eligible to participate.~   "
176246|NCT01258218|"~     The intent of this study is to evaluate the performance of the implanted Accent MRI TM system~     in a clinical setting and optionally in the MRI environment. This system includes the St.~     Jude Medical Tendril MRI™ lead and SJM Accent MRITM DR pacemaker. Also the MRI Activator™~     will be evaluated in this study. The MRI Activator is a handheld device that allows the user~     to enable and disable MRI Settings as well as check the status of MRI Settings in the~     pacemaker. The patient population under study includes patients with a standard bradycardia~     pacing indication.~   "
176247|NCT01258205|"~     The purpose of this study is to assess the safety and tolerability of AMG 139 following~     multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in~     subjects with mild to severe Crohn's disease (CD).~   "
176248|NCT01258192|"~     The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy~     with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.~   "
176249|NCT01258179|"~     The purpose of this study is to analyze the peri-operative expression of pancreatic stone~     protein and pancreatitis-associated protein in surgical patients following major abdominal~     surgery by blood samples.~   "
176250|NCT01258166|"~     Ulnar translocation of the carpus is a form of wrist instability where the small bones of the~     wrist shift out of position. It is well recognized in patients with rheumatoid arthritis, but~     can also occur after a traumatic event, such as a violent football tackle or a fall from a~     height. The treatment options vary considerably, and there is no consensus of how to best~     address this injury pattern.~      Because traumatic ulnar translocation is relatively rare, the diagnosis may be missed or~     delayed, causing problems for the patient such as persistent pain and loss of function. The~     investigators present 11 cases of this injury, discuss how to recognize it, and report our~     results after different treatment methods.~   "
176252|NCT01258140|"~     Computed tomography pulmonary angiography (CTPA) is the imaging method of choice to rule out~     acute pulmonary embolism based on its high sensitivity and specificity. Unfortunately, CTPA~     uses iodinated contrast media and can provoke contrast induced nephropathy. On the other~     hand, Computed tomography uses ionising radiation and is responsible for the half of the~     radiation exposure coming from medical sources.~      Recent studies have proven that low-dose CTPA protocols using Computed tomography tube energy~     of 80 kVp and reduced volume of iodinated contrast media provide an increased vessel signal~     and good image quality at a significantly reduced patient exposure. However, there are no~     data on the sensitivity of low-kVp protocols.~      The aim of this prospective randomized trial is to detect any difference between a~     normal-dose and a low-dose CTPA protocol in the diagnostic accuracy in the detection of acute~     pulmonary embolism (PE).~   "
176253|NCT01258127|"~     The main purpose of this randomized phase II trial is to evaluate the clinical feasibility~     and activity of administering adjuvant chemotherapy of pemetrexed/carboplatin compared with~     vinorelbine/carboplatin in patients with completely resected non-small cell lung cancer~     (NSCLC).~   "
176254|NCT01258114|"~     Public health campaigns and industry-supported changes in our food supply have obviously~     failed to control the epidemic to date. However, customized life style modification programs~     (LSMP) comprising diet, physical activity and behavioral therapy (a set of principles~     designed to help patients achieve their goals) induce weight loss of 10% of baseline body~     weight after 16 to 26 weeks of intervention . Long-term weight control is then facilitated by~     an appropriate weight-loss maintenance strategy such as continued patient-therapist contact~     (whether provided in person or by telephone or e-mail). This strategy allows patients to~     stabilize at an average of 5% and 3% loss of baseline body weight after 1 and 2 years,~     respectively. Numerous reports have concluded that this modest weight loss contributes to~     important health benefits.~      However, the high dropout rate during weight-management strategies presumably means that~     treatment is mainly effective in highly motivated patients, as the highest success rates are~     likely to be reported among study completers. Many individuals appear to conclude that the~     benefits of weight-management strategies are not worth the cost (i.e. time, money, and~     continued unrewarding efforts). This underlines the critical need to implement new, practical~     and affordable strategies to induce and maintain weight loss that can be achieved by most~     patients.~      The main objective of this study is to test the hypothesis that a 3 week intensive course of~     spa therapy can reduce the weight (and/or BMI) of overweight or obese patient at 14 months~     (BMI from 27 to 35).~   "
176255|NCT01258101|"~     This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys~     (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with~     chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups~     receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two~     doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment~     is 16 or 24 weeks with a 24-week follow-up.~   "
176256|NCT01258088|"~     The purpose of this study is to determine how much drug is absorbed throughout the body after~     being applied to the skin.~   "
176257|NCT01258075|"~     Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM)~     to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have~     been treated with Metformin or have had no antidiabetic drug treatment in the previous three~     months.~      Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well~     tolerated, and shows improved blood sugar control (as evidenced by a significant change from~     baseline in hemoglobin A1C [HbA1c]).~   "
176258|NCT01258062|"~     This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal~     powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of~     age who are eligible for study participation will be enrolled in the trial. It is expected~     that 10 subjects will be screened to obtain 7 subjects who will be eligible for study~     participation.~      The primary objective is to determine the frequency and severity of local and systemic~     adverse events of vaccine.~      The secondary objective is to assess the immunogenicity of the vaccine based on geometric~     mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.~   "
176259|NCT01258049|"~     The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is~     better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after~     the start of treatment in children with severe malaria, or uncomplicated malaria with~     gastrointestinal complications~   "
176260|NCT01258036|"~     The aim of this study is to analyze the hereditary determinism of bone microarchitecture~     measured at the distal radius and distal tibia from a case control-study of mother-daughter~     pairs.~   "
176261|NCT01258023|"~     The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R)~     in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It~     is expected that when administered once the vaccine fulfills all serological efficacy~     criteria required for the elderly population age 60 years and older.~   "
176262|NCT01258010|"~     Spinal surgery may be associated with substantial blood loss which often requires erythrocyte~     transfusion. Transfusion of red blood cells (RBC) is not free of adverse events and has been~     associated with increased risks of infection, and globally higher morbidity and mortality.~      Different techniques have been used to reduce perioperative blood losses and related~     transfusions. Tranexamic acid has been used successfully in cardiac and hepatic surgery.~     However, only a few studies have reported on the use of antifibrinolytic drugs in spinal~     surgery.~      This study was designed to assess the efficacy and safety of tranexamic acid in spinal~     surgery for the reduction of RBC transfusion.~      Hypothesis: the infusion of tranexamic acid during spinal surgery will reduce the risk of~     receiving a RBC transfusion and, in those patients transfused, reduce the number of blood~     products administered.~   "
176263|NCT01257997|"~     This pilot study is using a novel technology to measure the rate of turnover of new fat~     cells. Analysis of volunteer samples is ongoing, however the study is currently not enrolling~     new volunteers.~   "
176264|NCT01257984|"~     The objective of the study is to evaluate the effect of the dispenser's buzzer function on~     compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP)~     containing oral contraceptive (OC) in a flexible extended regimen when administered for~     approximately 12 months to healthy female volunteers who request contraception.~   "
176265|NCT01257971|"~     This is a multi-centre non-interventional study of patients who are treated with any HMGCoA~     reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and~     fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in~     accordance with SmPCs approved in Croatia. Data collection for each patient will take place~     at a single visit. The investigator will complete a Case Report Form with the patient's~     demographics, the presence of the factors for high cardiovascular risk, current treatment,~     cholesterol values as well as with further treatment decision.~   "
176266|NCT01257958|"~     Phase 1 study of 19-nor Vitamin D in relapsing-remitting MS. Primary measure is MRI.~   "
176267|NCT01257945|"~     This randomized, controlled exercise intervention with three groups compares two exercise~     approaches to standard of care. Supervised interventions are administered for four months,~     with emphasis on patients adopting exercise habits to continue to exercise for an additional~     12 months. Functional outcomes are measured at the completion of the supervised exercise (4~     months) as well as 10 and 16 months.~   "
176268|NCT01257932|"~     The investigators have developed imaging protocols to monitor and predict breast cancer~     response to neoadjuvant chemotherapy, both prior to and as early as possible during the~     course of treatment.~      The efficacy and practicality of conventional imaging approaches in the neoadjuvant~     chemotherapy setting varies and identifies the need for alternate functional imaging~     strategies. Diffuse optical spectroscopic imaging is an experimental imaging method that~     allows patients to be followed from baseline through treatment and surgery with a~     cost-effective, bedside, handheld scanning probe. The researcher evaluates a harmonized~     diffuse optical spectroscopic imaging technology platform that has been standardized for~     neoadjuvant chemotherapy monitoring. Diffuse optical spectroscopic imaging is an academic~     research platform that is non-invasive. Studies will be performed in five clinical sites on~     approximately 60 neoadjuvant chemotherapy patients.~   "
176269|NCT01257919|"~     Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in~     comparison to Azelaic Acid gel.~      Assessment of safety after repeated skin application.~   "
176270|NCT01257906|"~     ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) gel, marketed by Medicis, The~     Dermatology Company®, is a safe and effective topical therapy used for the treatment of acne~     vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of clindamycin~     phosphate (1.2%) and tretinoin (0.025%) topical gel and the current study is designed to~     evaluate the bioequivalence of this formulation to ZIANA®.~   "
176271|NCT01257893|"~     The purpose of this study is to compare the rates of aspirin resistance (high residual~     platelet reactivity) between women with episodic and chronic migraine and women without~     migraine.~      Emerging evidence suggests that migraineurs, especially women < 45 years who have aura, have~     an increased risk of stroke and myocardial infarction (MI, or heart attack). The mechanism~     linking migraine, stroke and MI is unclear although increased platelet activation and~     aggregation observed during and between migraine attacks may be a plausible theory.~      Aspirin is an inexpensive, relatively safe antiplatelet drug that reduces the risk of stroke~     and MI. Preliminary data suggest that aspirin's (325mg) therapeutic effect on platelet~     inhibition may be reduced in migraineurs (i.e., aspirin resistance), thus limiting aspirin's~     effectiveness at preventing stroke and MI risks in persons with migraine. Additional research~     is warranted to confirm these findings in migraineurs because daily, low-dose aspirin 81 mg~     is the recommended first line therapy for primary and secondary prevention of stroke and MI~      The researchers hypothesize that resistance to aspirin 81mg may occur more frequently in~     women with episodic and chronic migraine than in women without migraine. The findings may~     have important implications for women who have migraine and use aspirin to prevent migraine~     symptoms or comorbidities associated with migraine including stroke and MI.~   "
176272|NCT01257880|"~     The purpose of the study is to compare the rate of comorbidities associated with migraine~     aura (MA) between persons who have a large circulatory right-to-left shunt (RLS) and those~     who do not have RLS.~      Approximately 50% of individuals who have MA also have RLS due to patent foramen ovale (PFO).~     A PFO is an anatomical opening or flap between the upper chambers of the heart or atria that~     permits blood to pass from the right of the heart to the left side of the heart, without~     first going to the lungs to be filtered and oxygenated. Many health conditions and clinical~     syndromes including stroke, sleep apnea, and migraine have been linked to PFO. Although the~     mechanism is undetermined, it is hypothesized that microscopic blood clots and chemicals such~     as serotonin can pass through the PFO, travel to the brain, and cause headache and aura.~      Persons who have MA are at increased risk for stroke and transient ischemic attacks relative~     to people who do not have migraine. Migraine is also associated with the presence of white~     matter lesions in the brain and mild deficits in cognitive function associated with the~     posterior brain (vision, memory, processing speed). The risk of stroke in migraine is highest~     for women under the age of 45 who have aura and a high number of migraine headache days per~     month. No convincing evidence has been produced to explain the mechanism for the increased~     risk of ischemic stroke in migraine; however, increased platelet activation and aggregation~     is a plausible theory.~      We hypothesize that migraineurs with aura and large RLS (presumably due to a PFO) will be~     more likely to have sleep apnea, increased platelet activation, cognitive deficits,~     alterations in cerebral vasomotor function, and white matter lesions than migraineurs with~     aura who do not have PFO. The results of this exploratory study will generate hypotheses as~     to why subgroups of migraineurs have an increased risk of stroke and the impact of large PFO~     on comorbid conditions associated with migraine aura. Early identification of migraine~     subgroups with a constellation of clinical syndromes that increase risk of neurovascular~     diseases will allow initiation of preventive strategies that may ultimately reduce burden and~     improve the productive quality of life for these individuals.~   "
176273|NCT01257867|"~     This study investigates the effects of daily use of lithia water on blood tests of neuronal~     oxidative stress, mood, and well-being. Lithia water is a type of pure spring water~     containing trace levels of lithium, which is a naturally occurring mineral. Neuronal~     oxidative stress is caused by normal chemical reactions in the human body that sometimes~     result in damage to brain cells. Participation in this study will last for 8 weeks and~     includes daily use of study water for drinking.~      The primary objective of this pilot study is to test the hypothesis that, in healthy male~     participants, daily use of lithia water will improve neurogenesis and antioxidant capacity as~     measured by serum levels of brain-derived neurotrophic factor (BDNF) and oxidative stress~     markers. Secondary objectives will include examining self-reported changes in mood,~     cognition, and well-being.~   "
176274|NCT01257854|"~     Test the correlations between the pharmacogenetic and pharmacokinetic of Busulfan IV in~     children receiving hematopoietic stem cell transplantation.~   "
176298|NCT01257542|"~     15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the~     number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.~   "
176407|NCT01256125|"~     Allogene MSCs transplantation will be performed in patients with chronic liver diseases~     through peripheral vein and therapeutic effects including short-term effects and long-term~     follow-up will be compared and investigated.~   "
176275|NCT01257841|"~     The original study executed between 2002-2004 was an interventional trial in which 20,~     healthy, normal-weight female subjects were randomized to a four-day fast plus daily~     subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a~     placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid~     function, and cortisol secretion. The current study is a secondary analysis focussed on the~     placebo group which underwent a four-day fast. The study is looking at the effects of fasting~     on gut-derived hormones and inflammatory markers in healthy, normal-weight women. The~     hypothesis for this secondary analysis was that four days of fasting would augment levels of~     orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones,~     while suppressing secretion of inflammatory cytokines.~   "
176276|NCT01257828|"~     CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury~     worldwide. While there is evidence from the recently completed SpineNet prospective study~     that surgical decompression is an effective treatment for CSM, it is clear that many patients~     have remaining neurological impairment. While surgery is relatively safe, approximately 3% of~     patients maintain a neurological problem. Given this background and data from preclinical~     models of non-traumatic and traumatic spinal cord injury, there is strong evidence to~     consider the potential benefit of adding a neuroprotective drug which aids in the treatment~     of patients with CSM whom are undergoing surgical decompression. Riluzole is FDA-approved for~     the treatment of amyotrophic lateral sclerosis, which has some similar clinical features to~     CSM. Riluzole is currently under investigation for traumatic spinal cord injury. Given this~     background, there is a strong basis to consider studying the potential neurological benefits~     of Riluzole as a treatment to surgical decompression in patients with CSM.~   "
176277|NCT01257815|"~     This study evaluates a new investigational treatment regimen of three consecutive monthly~     doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for~     the first three months then two-monthly follow-up until 18 months in patients with visual~     impairment due to diabetic macular oedema.The aim of the study is to determine if this~     treatment regimen is effective and safe in these patients.~   "
176278|NCT01257802|"~     The purpose of this study it to determine whether the use of a gonadotropin releasing hormone~     (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with~     rheumatic diseases will provide greater ovarian protection than placebo.~   "
176279|NCT01257789|"~     Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant~     learning curve. We report the results of a systematic training programme from a high volume~     bariatric center measuring the outcome by comparing the results with data from a consecutive~     series of 1000 fast track LRYGB.~      Method: Using a stepwise training programme the RY gastric bypass operation was divided into~     an upper and lower procedure and subdivided into 11 well defined steps. A laparoscopic~     surgeon without experience in upper GI surgery was mentored by an experienced bariatric~     surgeon. During 6 months full time fellowship 300 operations were performed.~      Results: The trainee surgeon performed 61 upper procedures, and 121 lower procedures in which~     the mentor surgeon did the other part of the operation. In 110 patients the trainee performed~     both procedures. Two percent had peri-operative complications compared to 1% of 1000~     patients. All were repaired and had an uneventful recovery. Two percent had postoperative~     complications < 30 days compared to 2.8% in the clinic. In the trainees series there were no~     leaks compared to 1% in 1000 patients. Operative time was 56/55/70 min for operation~     0-100/100-200/200-300 compared with an average of 47 minutes registered in the clinic.~     Concerning time to discharge there was no difference between patients operated by the trainee~     and the standard of the clinic.~      Conclusion: Using a systematic training program in laparoscopic RY gastric bypass surgery~     eliminates morbidity of the learning curve without affecting the volume.~   "
176280|NCT01257776|"~     A prospective, multicenter, open, randomized, parallel-group controlled study for two levels~     of dose.~      The study population will consist of 30 non-diabetic patients with critical chronic ischemia~     in at least one of the lower limbs (CLI) and without possibility of revascularization, from~     whom results can clinically be evaluable, of whom, 20 patients will be included in the~     experimental group (10 for each dose level) and 10 in the control group.~      In each of the two dose levels to be used in the study, 15 patients will be included, who~     will be randomized to the experimental group or the control group according to a distribution~     2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level,~     we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose~     tissue) and 5 patients in the control group (conventional treatment)~   "
176281|NCT01257763|"~     The purpose of this study is to evaluate the safety and tolerability of an experimental~     device that introduces microscopic channels into the skin. Creating microscopic channels in~     the skin allows for better absorption of various medications applied to the skin, and this~     study will determine if the study device offers a tolerable method by which to introduce~     these holes. The study population will include 54 individuals, ages 18-74 years old, with a~     roughly equal distribution of skin colors. Each subject will have a total of three visits 24~     hours apart from one another. The study device will be applied at the Baseline and Day 1~     visits. At various timepoints before and after device application, skin assessments for~     irritation will be completed using a 7-point Skin Reaction Scale and photographs will be~     taken. Subjects will report pain associated with device application using a standardized pain~     scale. At the baseline visit, a member of the research staff will administer applications of~     the study device on the side of the subject's forehead, temple and the area below and to the~     side of the nose on randomly selected sides of the face. The side of the face at each~     location not receiving application of the study device will receive applications of a dummy~     device. Subjects will not be informed of which device is the study device and which is the~     dummy device. At the Day 1 visit, a member of the research staff will administer study~     device applications to the center of the subject's forehead. The subject will also self-apply~     the study device to the chin, under the instruction of the research staff member. At the Day~     2 visit, final skin assessments will be made and the subject will be evaluated and treated~     for any persistent skin irritation. Differences in skin irritation between sites of study~     device application and dummy device application will be determined, as well as several~     other endpoints.~   "
176282|NCT01257750|"~     The purpose of this study is to determine the safety and efficacy of a drug [Pazopanib~     (Votrient)] as a treatment for corneal neovascularization. The cornea is the clear, central~     portion of the eye and neovascularization means blood vessel growth. The cornea is typically~     avascular, or without blood vessels. Corneal neovascularization in the cornea and can put~     vision at risk. Numerous diseases of the cornea such as inflammation, ischemia (restriction~     of blood supply), infection, degeneration (or deterioration), trauma, or corneal stem cell~     deficiency can lead to corneal neovascularization. This major ocular complication can lead to~     corneal scarring, edema (swelling), lipid deposits, and inflammation that may significantly~     alter your vision. In addition, it worsens the outcome of potential future treatments, such~     as a corneal transplant. A corneal transplant is a treatment that many patients with severe~     corneal disease may ultimately need.~   "
176283|NCT01257737|"~     This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate)~     in participants with a urea cycle disorder (UCD) who completed the safety extensions of~     HPN-100-005 (NCT00947544; HPN-100-005SE), HPN-100-006 (NCT00947297; HPN-100-007), or~     HPN-100-012 (NCT01347073; HPN-100-012SE). The initial studies were 1- to 2-week crossover~     studies, and their associated safety extensions were 12-month, open-label studies. All~     participants who completed the initial studies were eligible to enroll in the associated~     safety extension studies, and new participants were also permitted to enroll directly into~     the safety extension studies.~   "
176284|NCT01257724|"~     The investigators have developed an online database called 'Synthesized HIV/AIDS Research~     Evidence' (SHARE), which is designed to support the use of research evidence by those working~     in the HIV/AIDS sector. This study will evaluate whether a full-serve version of SHARE~     increases the use of research evidence by community-based organizations as compared to a~     self-serve version. The full-serve version of SHARE consists of several components: 1) an~     online searchable database of synthesized research evidence relevant to HIV/AIDS , 2)~     periodic emailed updates, 3) access to user-friendly summaries and 4) peer-relevance~     assessments. The self-serve version consists only of a listing of relevant synthesized~     research evidence . The investigators will also interview participants in the study to obtain~     feedback about SHARE, how helpful it was in their work, why it was helpful (or not helpful),~     what aspects were most and least helpful and why, and recommendations for improving it.~   "
176285|NCT01257711|"~     Both Billroth II and Roux en Y are acceptable techniques of reconstruction after subtotal~     gastrectomy, however the debate one which is better remains unanswered. The aim of this study~     is to compare Billroth II and Roux en Y reconstruction techniques after radical distal~     subtotal gastrectomy for gastric cancer in terms of postoperative outcomes and quality of~     life. The investigators hypothesize that Roux en Y will have lesser gastrointestinal symptoms~     and reflux problems when compared to Billroth II reconstruction. Patients with resectable~     gastric cancer meeting the inclusion criteria will be consented and enrolled. Data on~     demographics, nutrition, gastrointestinal symptoms, and quality of life will be collected.~     They will be randomized after completion of distal subtotal gastrectomy to under go either~     Roux en Y or Billroth II reconstruction. Surgery data will be collected post-operatively.~      At 6 months follow up a repeat nutritional assessment using clinical and biochemical~     parameters will be carried out. The biochemical markers are part of routine follow up. The~     final assessment will be at the one year post surgery visit when by interview using EORTC 30~     questionnaire quality of life data, gastrointestinal symptoms and nutritional assessment and~     surgery data for recurrence will be repeated. At one year patients will also have upper~     gastrointestinal endoscopy, which is part of routine follow up. At endoscopy stump gastritis~     will be graded and esophageal reflux assessed as per Los Angeles classification. It is~     postulated that 5% of the patients on Roux en Y reconstruction will experience poor clinical~     symptoms compared to 25% of those on Billroth II based on reflux symptoms. To achieve a~     statistical significance with 95% power and a 2-sided test of 5% for this 20% clinical~     difference, 80 subjects for each arm will be required. Factoring a 10% attrition rate for~     mortality and lost to follow up, a total of 160 subjects to be randomized equally will be~     recruited.~   "
176286|NCT01257698|"~     The purpose of this study is to see if glaucoma eye drops (dorzolamide-timolol) have any~     effect on the duration of an intraocular gas bubble following pars plana vitrectomy.~   "
176287|NCT01257685|"~     The pathogenesis of nonalcoholic fatty liver disease has not been fully elucidated. The most~     widely supported theory implicates insulin resistance as the key mechanism leading to hepatic~     steatosis, and perhaps also to steatohepatitis.~      Selenoprotein P(SeP) is a secretory protein primarily produced by the liver. Previous studies~     demonstrated that SeP, a liver-derived secretory protein, causes insulin resistance.~      Therefore, the purpose of this study is to determine the different Sep levels between healthy~     normal group and NAFLD group.~   "
176288|NCT01257672|"~     Vomiting in children with acute gastroenteritis is a major factor of failure of oral~     rehydration therapy. Effective symptomatic treatment of vomiting would lead to an important~     reduction in the use of Intravenous Fluid Therapy. Available evidence on symptomatic~     treatment of vomiting shows the efficacy of the most recently registered molecule~     (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice,~     such as domperidone, is lacking.~      The aim of this multicentre, double-blind randomized controlled trial is to compare the~     efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children~     with acute gastroenteritis who have failed Oral Rehydration Therapy.~   "
176289|NCT01257659|"~     The primary objective of this study is to compare the function results between two methods~     for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis~     is that the relatively new type of endo-anal surgery will result in better voiding function~     compared to the traditional vaginal surgery.~   "
176290|NCT01257646|"~     The main objective of this study is the estimation and comparison of the dephasing between~     the switch heel and the inertial placed on the paretic foot compared to the events of the~     gait cycle determined by a Gaitrite system (beginning and end of the swing phase) in~     conditions without stimulation.~   "
176291|NCT01257633|"~     The main objective of this study is to determine the rate of healthy surgical margins after~     tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early~     stage (T1-T2) laryngeal cancer.~   "
176292|NCT01257620|"~     This exploratory study has been designed to determine the effect of the probiotic~     Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical~     features, Quality of Life parameters (QoL), intestinal permeability and inflammatory markers~     of patients having positive serological evidences of Celiac Disease.~   "
176293|NCT01257607|"~     The objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3~     to placebo for the treatment of the signs and symptoms of dry eye.~   "
176294|NCT01257594|"~     The purpose of this study is to test the effectiveness of a drug called erlotinib in treating~     the tumor. This is a multi-center pilot study that explores efficacy and molecular effects of~     high dose weekly erlotinib for recurrent EGFR vIII mutant malignant gliomas, and correlate~     molecular profile of pre-treatment tissue with outcome.~   "
176295|NCT01257581|"~     The purpose of the study is to evaluate the safety and efficacy of high dose creatine and two~     dosages of tamoxifen treatment in amyotrophic lateral sclerosis (ALS).~   "
176296|NCT01257568|"~     This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip~     replacement (THR) with a cementless application in a consecutive series of patients who meet~     the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years~     and clinical outcomes for up to 10 years after surgery.~   "
176297|NCT01257555|"~     The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy~     for the treatment of acne and concomitant symptoms associated with the disease, including~     erythema.~   "
176299|NCT01257529|"~     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a~     pregabalin controlled release tablet following either a low, medium, or high-fat evening meal~     as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the~     safety and tolerability of a single dose of a pregabalin controlled release tablet following~     a low, medium, or high fat evening meal as compared to a single dose of the pregabalin~     immediate release capsule.~   "
176300|NCT01257516|"~     The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a~     pregabalin controlled release tablet as compared to multiple doses of the pregabalin~     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin~     controlled release tablet as compared to multiple doses of pregabalin immediate release~     capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin~     controlled release tablet as compared to multiple doses of the pregabalin immediate release~     capsule.~   "
176301|NCT01257503|"~     A randomized controlled trial of a commercially available homeopathic cold remedy will be~     conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract~     infection will be randomized to receive either the homeopathic remedy or placebo. Parents of~     study children will administer 5 ml of the study medication up to 6 times per day as needed~     to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms~     (for up to the first 10 doses). In addition, parents will rate their child's overall symptom~     severity and functional status over the first 3 days of the cold. It is postulated that~     children receiving the active homeopathic remedy will have better symptom relief and that~     their symptom severity and functional status will improve more rapidly than those receiving~     placebo.~   "
176302|NCT01257490|"~     This study recruited cigarette smokers under supervision in community corrections (e.g.,~     probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12~     weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of~     bupropion treatment and 4 sessions of intensive counseling around smoking cessation. The~     study was stratified on race such that equal proportions of African Americans and Caucasians~     were enrolled in the two study groups. It was hypothesized that smokers receiving intensive~     counseling will have higher quit rates compared to smokers receiving brief advice to quit.~   "
176303|NCT01257477|"~     An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current~     clinical practice setting.~   "
176304|NCT01257464|"~     The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV)~     inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes~     (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.~   "
176305|NCT01257451|"~     This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly~     patients with Type 2 Diabetes Mellitus (T2DM).~   "
176306|NCT01257438|"~     The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent~     Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of~     the Arteriovenous (AV) access circuit of hemodialysis patients with either of the two~     predominant vascular access types - those with an AV graft and those with an AV fistula.~   "
176307|NCT01257425|"~     The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin~     pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the~     curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.~   "
176308|NCT01257412|"~     This study intends to compare the efficacy and safety of dapagliflozin versus placebo in~     treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet~     and exercise alone.~   "
176309|NCT01257399|"~     To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug,~     marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool),~     in patients with Ulcerative Colitis in remission, treated for 48 weeks.~   "
176310|NCT01257386|"~     To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug,~     marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients~     with active ulcerative colitis (UC) treated for 8 weeks.~   "
176311|NCT01257373|"~     The goal of this study is to assess the long-term efficacy and safety of Firebird2~     Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in~     diabetes.~   "
176312|NCT01257360|"~     The objective of this trial is to obtain evidence that, in patients with RAS wildtype tumors,~     a chemotherapy-free combined modality treatment with panitumumab is clearly superior to~     radiotherapy alone and achieves a pCR rate comparable to that after radiochemotherapy~     including two-drug combinations while reducing the toxicity compared to these two-drug~     regimens.~   "
176313|NCT01257347|"~     The purpose of this study is to test whether accurately measuring patients' adherence to~     their blood pressure medications with electronic pillbox monitors and then providing~     clinicians with this information can improve the clinical management of uncontrolled~     hypertension.~   "
176314|NCT01257334|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy~     to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic~     control.~      Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled~     patients (HbA1c > 10%)~   "
176315|NCT01257321|"~     Obstructive sleep apnea syndrome (OSAS) is the most common indication for tonsillectomy and~     adenoidectomy in young children. According to previous studies, as much as 8 to 20% of~     patients will develop post operative respiratory complications requiring medical~     intervention. The pre-operative risk factors that could predict respiratory complications~     retrospectively analyzed were young age, obesity and high preoperative apnea-hypopnea index.~     Despite the removal of obstructing lymphoid tissue, upper airway obstruction occurs on the~     first postoperative night in children with OSA. There is a debate regarding the~     post-operative duration and monitoring needed in children with OSA.~      Hypothesis:~      Pre-operative, operative and immediate post-operative parameters could predict post~     tonsillectomy respiratory complications.~   "
176316|NCT01257308|"~     We wants to analyse the EML4-ALK mutation rate in the patients who have non-small cell lung~     cancer.~   "
176317|NCT01257295|"~     Dietary fibers likely have a role in body weight management. They may increase satiety and,~     as a consequence, reduce energy intake during the next meal. There are, however, many~     different types of dietary fiber, which have diverse physical properties and can therefore~     impact these outcomes differently. It is, however, unclear whether dietary fibers with~     different properties lead to differences in energy intake during the next meal. The objective~     of this study is to study the effect of pectin in 4 different physicochemical states on ad~     libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones,~     gastric emptying rate, feelings of satiety and the method of fiber supplementation. We~     hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to~     low viscous and low gelling fibers.~   "
176318|NCT01257282|"~     This study includes patients with stable coronary artery disease without previously known~     myocardial infarction, and investigates the prevalence of clinically unrecognized myocardial~     damage and its prognostic implication.~   "
176319|NCT01257269|"~     Hereditary thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome) is a rare disorder~     characterized by thrombocytopenia as a result of platelet consumption, microangiopathic~     hemolytic anemia, occlusion of the microvasculature with von Willebrand~     factor-platelet-thrombic and ischemic end organ damage. The underlying patho-mechanism is a~     severe congenital ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin type 1~     motif, 13) deficiency which is the result of compound heterozygous or homozygous ADAMTS13~     gene mutations.~      Although considered a monogenic disorder the clinical presentation in Upshaw-Schulman~     syndrome patients varies considerably without an apparent genotype-phenotype correlation. In~     2006 we have initiated a registry for patients with Upshaw-Schulman syndrome and their family~     members to identify possible triggers of acute bouts of TTP, to document individual clinical~     courses and treatment requirements as well as possible side effects of long standing plasma~     substitution, e.g. alloantibody formation or viral infections.~   "
176320|NCT01257256|"~     The current study attempted to explore the relationships among stressors (cognitions of~     illness, socioeconomic status, social support, marital stressor, social stressor, etc),~     perceived stress level, and emotional reactions (anxiety and depression) of infertile~     patients and to propose the measurement and structural models of infertile aniexty and~     depression.~   "
176321|NCT01257243|"~     The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine,~     guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough~     treatment.~   "
176322|NCT01257230|"~     The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses~     of tiotropium bromide compared to placebo in adolescent patients with moderate persistent~     asthma. Efficacy and safety will be assessed by measuring lung function parameters and~     evaluating the effects on asthma exacerbations, on Quality of life, on health care resource~     utilisation an on the number of adverse events.~   "
176323|NCT01257217|"~     The purpose of this study is to evaluate visual and refractive parameters in a series of~     subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during~     cataract surgery.~   "
176324|NCT01257204|"~     To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of~     daclatasvir with pegylated interferon alfa-2a and ribavirin.~   "
176325|NCT01257191|"~     The goal of this study is to see how the type and size of particles found in air pollution~     affects inflammation in the nose in people who are skin test positive to at least one~     allergen. It has been observed that pollution makes allergies worse. It has also been~     suggested that very small particles may affect allergies more than larger particles.~   "
176326|NCT01257178|"~     The purpose of this study is to evaluate the impact of hepatic dysfunction on the~     pharmacokinetics and safety of LY2624803 and its major metabolite, LSN2797276.~   "
176327|NCT01257165|"~     Zopiclone, a widely used hypnotic drug, is frequently found in blood samples taken from~     drivers suspected of driving under the influence. In this study, the investigators aim to~     correlate zopiclone serum concentrations with degrees of driving impairment in healthy~     volunteers by use of a validated driving simulator. The investigators also aim to compare~     their results with the results from a previous study that investigated zopiclone impairment~     of cognitive and psychometric tests.~   "
176328|NCT01257152|"~     A prospective, multicenter study:~        -  Primary objective: to assess the diagnostic yield of screening MRI compared to physical~          examination, mammography or ultrasonography in the detection of recurrence in patients~          treated with breast conserving therapy~        -  Secondary objective: to describe the size, type, grade, and nodal status of cancers seen~          only on MRI and to estimate the rate of benign biopsies and short interval follow-up~          induced only by MRI in this population.~   "
176329|NCT01257139|"~     This is a phase III randomized multicenter study involving subjects over 70 years of age with~     non small-cell lung cancer of IV and a PS of 0, 1 or 2, who have not previously received~     chemotherapy. The aim is to validate the use of a simplified geriatric scale (SGS) as a~     screening tool. If the SGS results are normal, the patient will be treated with dual-agent~     therapy based on platinum (carboplatin + pemetrexed if the histology is non epidermoid,~     carboplatin + gemcitabin if the histology is epidermoid), with no further geriatric~     assessment. When the SGS reveals abnormalities, a comprehensive geriatric evaluation (CGE)~     will be used to define two subpopulations on Balducci's fragility scale, who will receive~     either monotherapy (docetaxel) or best supportive care.~      The strategy based on the SGS will be compared with a treatment algorithm based on standard~     criteria (PS and age), with no specific geriatric assessment. The main endpoint is the time~     to treatment failure. The SGS is composed of the Charlson co-morbidity scale, functional~     assessment based on PS, Katz' ADL scale, Lawton's simplified IADL scale, simplified cognitive~     assessment with the mini-MMSE according to Schultz-Larsen, a geriatric depression scale (GDS~     5), and screening for a geriatric syndrome defined by the existence of dementia, repeated~     falls, and urinary and fecal incontinence. The SGS will be validated by comparison with the~     CGE, that will be administered systematically at enrollment. All the SGS items are included~     in the CGE.~      Secondary endpoints will be quality of life (measured with the LCSS and EuroQoL~     questionnaires), overall survival, the objective response rate, and toxicity. The~     investigators will also study the predictive power of nutritional indices such as the PINI~     and the Buzby score with respect to survival, the treatment response, and tolerability.~   "
176330|NCT01257126|"~     This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to 7~     years. The objective of the study is to compare the efficacy of a single dose of both~     diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper~     respiratory tract infection.~   "
176331|NCT01257113|"~     The purpose of this study is to determine whether there are any difference between supervised~     exercise therapy and homebased exercise when looking at pain and function for patients with~     shoulder pain.~   "
176332|NCT01257100|"~     Background:~      - Nasopharyngeal carcinoma (NPC) a common malignant tumor in southern China and Southeast~     Asia. Infection with Epstein-Barr virus is believed to be necessary for the development of~     NPC; non-viral environmental factors, such as dietary consumption of nitrosamines, cigarette~     smoking, betel nut chewing, wood dust exposure and possibly exposure to formaldehyde, have~     been implicated in the disease. Genetic susceptibility may also play an important role in the~     development of NPC. However, more information is needed on the connections between genetic~     and environmental factors in NPC, particularly in areas where the cancer risk appears to be~     greatest.~      Objectives:~      - To examine the main effects of genetic factors and environmental exposures (e.g., cigarette~     smoking, betel nut chewing, formaldehyde, wood dust) on nasopharyngeal carcinoma risk.~      Eligibility:~        -  Cases: Individuals at least 21 years of age who have been diagnosed with NPC at one of~          the participating hospitals and have been residents of northern Taiwan for at least 6~          months.~        -  Controls: Hospital patients with diseases other than NPC at least 21 years of age,~          matched to NPC patients based on hospital, age at diagnosis, gender, and ethnicity.~      Design:~        -  This study involves a risk factor interview, medical record abstraction and biological~          sample collection.~        -  Participants will respond to interview questions about their lifestyle and risk factors~          thought to be involved in NPC development.~        -  All participants will provide blood and saliva samples for study. Participants who have~          been diagnosed with NPC will also provide consent to allow researchers to study tissue~          samples taken during tumor biopsies or surgeries.~        -  Treatment will not be provided as part of this protocol.~   "
176333|NCT01257087|"~     Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients~     with obesity. Many patients stop or reduce their medication after surgery and this can happen~     fairly quickly. The investigators do not know whether strict control of blood glucose/sugar~     after the operation makes any difference in the long term. Additionally many patients prefer~     their blood sugars to be a bit high because they are afraid of hypos.A number of studies~     have described patients whose eye, nerve and kidney disease has deteriorated when high sugars~     are controlled very quickly. The investigators want to ensure that surgery provides maximum~     benefit and remains safe in patients with diabetes. This study will help us decide if the~     investigators should be strict with blood glucose after obesity surgery operations or not and~     whether obesity surgery is safe for the eye, nerve and kidney complications of diabetes.~   "
176334|NCT01257074|"~     Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of~     this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as~     treatment for Herpes Labialis in comparison to acyclovir 50mg/g.~   "
176335|NCT01257061|"~     Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and~     impaired quality of life due specially pruritus and physical visible skin lesions. The~     propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g +~     dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.~   "
176336|NCT01257048|"~     The main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced~     magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients with~     moderate to severe chronic obstructive pulmonary disease (COPD) following treatment with~     either Oxis Turbuhaler or Symbicort Turbuhaler.~   "
176337|NCT01257035|"~     The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of~     response to neoadjuvant chemoradiation of locally advanced rectum cancer.~   "
176338|NCT01257022|"~     The main goal of the proposed study is to evaluate the efficacy of Familias Unidas (United~     Families), a family-based, ecodevelopmental intervention found to be previously efficacious~     in preventing and reducing behavior problems, illicit drug use, and unsafe sexual behavior in~     non-delinquent Hispanic adolescents (Pantin et al., 2003; Prado, Pantin, Briones et al.,~     2007).~      The study hypotheses are as follows:~      Hypothesis 1. Familias Unidas will be more efficacious than Treatment as Usual in preventing~     drug use among Hispanic first offending adolescents or those who are at risk for committing a~     first time offense over time.~      Hypothesis 1a. The effect of Familias Unidas on drug use will be partially mediated by~     improvements in family functioning.~      Hypothesis 2. Familias Unidas will be more efficacious than Treatment as Usual in preventing~     unsafe sexual behavior among Hispanic first offending adolescents or those who are at risk~     for committing a first time offense over time.~      Hypothesis 2a. The effect of Familias Unidas on unsafe sexual behavior will be partially~     mediated by improvements in family functioning.~      Hypothesis 3. Familias Unidas will be more efficacious than Treatment as Usual in preventing~     subsequent criminal offenses among Hispanic first offending adolescents or in preventing a~     first time offense for those at risk for committing a first time offense over time.~      Hypothesis 3a. The effect of Familias Unidas on subsequent criminal offenses will be mediated~     by family functioning.~   "
176339|NCT01257009|"~     Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which~     appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage.~     Experimental studies and some clinical studies have shown that statin therapy can reduce~     central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which is~     standard treatment for CKD, is known to lower sympathetic activity.~      The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further~     lower sympathetic activity in hypertensive stage 2-4 CKD patients.~      Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis~     blockers, blood pressure and sympathetic activity (quantified by assessment of muscle~     sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after atorvastatin~     20mg/day added.~      Ten other CKD patients will serve as time control and will be studied twice with an interval~     of 6 weeks without any change in medication, to quantify within subject reproducibility.~   "
176351|NCT01256853|"~     This is a phase I, dose escalation trial of MVA-EBNA1/LMP2 vaccine across a pre-defined range~     of doses in patients in remission having had an EBV+ nasopharyngeal carcinoma (NPC).~   "
176352|NCT01256840|"~     The purpose of this study is to see whether people who have restricted the number of calories~     they eat for a long period of time, compared to normal-eating and obese people, have markers~     of cellular aging that look younger.~   "
176340|NCT01256996|"~     In the last decade, the number of dental implantations continuously increases. However, at~     the same time, the prevalence of peri-implantitis increases, too. Although both surgical and~     non-surgical interventions are available for the therapy, there is no efficient and~     satisfying therapy option resulting in an adequate improvement of this disease.~      An innovative, low abrasive powder has been introduced for the therapy of periodontitis.~     However, the powder might be suitable for the peri-implantitis therapy, also, and could~     improve the effectiveness of the therapy. The usage of this powder in peri-implantitis~     patients has not been assessed in a clinical trial although the effectiveness in natural~     teeth has been demonstrated.~      The aim of this prospective, randomised, multi-centre trial is to assess the effectiveness of~     the aforementioned powder in peri-implantitis patients.~   "
176341|NCT01256983|"~     Sleep-wake dysregulation is a disturbance in the roughly 24-hour cycle of the circadian~     rhythm. Well known disorders presenting a sleep-wake dysregulation are seasonal affective~     disorder, jet lag and shift work. These people experience a serious mood change when the~     seasons change. When the day-night rhythm is desynchronized, they have sleep disturbances,~     little energy, and often feel depressed. An established intervention to treat this disorder~     is bright light therapy. Light therapy is used for affective disorders for shift workers, jet~     lag symptomatology and for advancing or delaying desynchronized rhythms.Two proxy measures~     for sleep-wake dysregulation are sleep quality and daytime sleepiness. It is known from cross~     sectional studies that renal transplant (RTx) recipients have a prevalence between 30% to 62%~     of poor sleep quality measured by self report; a prevalence of impaired daytime functioning~     of 34% 12 and a prevalence of depressive symptomatology of 20% to 22%. Sleep-wake~     dysregulation in other chronically ill population are a risk factor for morbidity and~     mortality.~      RTx nurses in the follow-up care are in the frontline for recipient's symptoms respectively~     problems. The psychosocial variables that should be addressed, having an association with~     morbidity and mortality are sleep, daytime functioning, adherence to immunosuppressive~     medication, exercise, smoking and depressive symptomatology.~      In the following research project we will address the following gaps: the fact that nature of~     sleep disturbances in RTx recipients has never been assessed, that there is no prevalence~     available on sleep-wake dysregulation and that there is no data on bright light therapy~     intervention in RTx recipients.~      Hypothesis: Renal transplant recipients having a sleep wake disregulation will have an~     improved sleep quality and less daytime sleepiness after 21 days of light therapy.~   "
176342|NCT01256970|"~     Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive~     age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic~     criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous~     as the syndrome. This first part of study is determine whether genetic polymorphisms~     influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and~     controls. Furthermore, women with PCOS were reported with high risk of cardiovascular~     disease, the investigators planned to calculate the difference of carotid intima-media~     thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal~     control to determine the premature atherosclerosis of women with PCOS.~   "
176343|NCT01256957|"~     The purpose of this study is to evaluate the ability of portable high efficiency particle air~     (HEPA) filters to reduce exposures to PM2.5 and woodsmoke air pollution indoors and to~     improve subclinical indicators of microvascular function, systemic inflammation, and~     oxidative stress among healthy adult participants.~   "
176344|NCT01256944|"~     Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive~     age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic~     criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous~     as the syndrome. Of those diagnosed with PCOS using the 2003 Rotterdam criteria, 61%~     fulfilled 1990 NIH criteria for unexplained hyperandrogenic chronic anovulation. The patient~     populations with the new phenotypes had less severe ovulatory dysfunction and less androgen~     excess than patients diagnosed using the 1990 NIH criteria. These findings might be common~     across all female populations with PCOS, whether in Oriental or Occidental countries. Data~     for clinical hyperandrogenism indicated that the prevalence of hirsutism in Taiwanese PCOS~     women is lower than that for Caucasians/Western women.~      The extent of metabolic abnormalities in women with PCOS may vary with phenotype, age and~     ethnicity. Obesity represents a major risk factor for metabolic syndrome and insulin~     resistance. Approximately 40-50% of all women with PCOS are overweight or obese. Obese~     subjects with PCOS had a higher risk of developing oligomenorrhea, amenorrhea and biochemical~     hyperandrogenemia than non-obese women with PCOS. Moreover, obese women with PCOS had~     significantly more severe insulin resistance, lower serum LH levels, and lower LH-to-FSH~     ratios than non-obese women with PCOS. PCOS women in Taiwan presented with higher LH-to-FSH~     ratio and lower insulin resistance than PCOS women in Western Countries. However, the average~     body mass index (BMI) was significantly lower in Taiwanese PCOS women than Western women,~     which might partially explain the difference between these two populations in terms of~     clinical and biochemical presentations.~      To further document the ethnic variation between women with PCOS in Taiwan and Western, the~     effect of obesity on the diagnosis and clinical presentations of PCOS-related syndromes~     should not be neglected in future studies. Therefore, the investigators plan to do this~     prospective study for evaluation the clinical and biochemical presentation of Taiwanese women~     with PCOS.~   "
176345|NCT01256931|"~     Organ transplant patients who participated in a retrospective study and received 2009~     Pandemrix vaccine during autumn 2009 are included in this study.~      The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison~     to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in~     patients and controls.Side effects to Fluarix vaccine are registered.~   "
176346|NCT01256918|"~     There is a correlation between phacodepth required for full thickness nuclear crack and the~     various grades of cataract~   "
176347|NCT01256905|"~     The purpose of this study is to evaluate if a drug commonly used to treat excessive day-time~     sleepiness, called armodafinil (Nuvigil), is also effective in improving the impairment in~     the attention commonly reported by patients with more advanced Parkinson's disease (PD) and~     Lewy body disease (LBD).~   "
176348|NCT01256892|"~     To evaluate the impact of induction of labour at 38 weeks with the induction of labour at 40~     weeks in women with insulin dependent gestational diabetes mellitus on maternal and fetal~     outcome.~   "
176349|NCT01256879|"~     The purpose of this research is to see if non-drug ingredients in capsules and oral solutions~     affect how well drugs are absorbed. This is called bioequivalence. Medications taken by~     mouth, such as capsules and solutions, need to be absorbed into the body in order to do any~     good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are~     called excipients or fillers. Excipients in the capsules and solutions can impact how much~     drug is absorbed into the body. This is called bioINequivalence. Capsules and solutions in~     this research contain the drug cimetidine. This drug is being used since it has high water~     solubility (can dissolve in water) and low ability to be absorbed.~   "
176350|NCT01256866|"~     The aim of this prospective randomized study is to compare the safety and efficacy of two~     strategies for sedation of critically ill patients submitted to mechanical ventilation:~     continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The~     two groups will be compared as to the incidence of of delirium, evaluated with the Confusion~     Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation~     using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or~     older intubated and mechanically ventilated for less than 48 hours prior to start of study~     drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146~     patients (73 patients in each group)~   "
176354|NCT01256814|"~     The purpose of this study is to assess a new behavioral intervention to help how people~     living with HIV/AIDS practice self-management skills. Specifically, we want to see if a new~     educational intervention can improve physical activity, sleep, mental wellness and quality of~     life in HIV(Human Immunodeficiency Virus)-infected men and women. We hypothesize that those~     who are in the intervention group will practice more self-management skills than those in the~     control group.~   "
176355|NCT01256801|"~     The investigators want to develop a gene expression profile for the prediction of~     immunotherapy response of patients with metastatic breast cancer presenting malignant pleural~     effusion.~   "
176356|NCT01256788|"~     This study will look at patients with post-operative treatment of a meniscal tear or~     degenerative joint disease (degenerative arthritis). They will be randomized into one of~     three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are~     randomized into the injection group will receive a series of three injections (one a week for~     3 weeks), then a booster injection at 6 months post-op. Several questionnaires will be~     given after the first set of injections, then again at a one year follow-up.~      The hypothesis is that patients receiving hyaluronic acid injections will have better pain~     and function scores as compared with placebo and no further treatment at all time points.~   "
176357|NCT01256775|"~     Peripheral arterial disease (PAD) is almost invariably associated with a generalized~     atherosclerotic involvement of the arterial tree and endothelial dysfunction. Previous short~     term studies showed improvement of vascular reactivity and walking capacity in PAD patients~     by measures aimed at restoring Nitric Oxide (NO) production. NO is also known to prevent the~     progression of atherosclerosis. We wished to assess whether the prolonged administration of a~     NO-donating agent (NCX 4016) improves the functional capacity of PAD patients and affects the~     progression of atherosclerosis as assessed by carotid intima-media thickness (IMT).~      Four hundred forty two patients with stable intermittent claudication were enrolled in a~     prospective, double blind, placebo-controlled study and randomized to either NCX 4016 800mg~     bid or its placebo for 6 months. The primary study outcome was the absolute claudication~     distance (ACD) on a constant treadmill test (10% incline, 3km/hr); main secondary end-point~     was the change of the mean far-wall right common carotid artery IMT.~   "
176358|NCT01256762|"~     The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat~     + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab)~     alone for patients with locally recurrent or metastatic breast cancer who have not received~     chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.~   "
176359|NCT01256749|"~     The fundamental reason for comparing the ability of the Frontal Sedline TM~     Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for~     burst suppression detection is to determine if a less expensive, less invasive and possibly~     more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced~     intraoperative burst suppression therapy (IBST) for cerebral protection.~   "
176360|NCT01256736|"~     The purpose of this study is to evaluate 1 year extension study of the efficacy and the~     safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with~     moderate to severe active RA and an inadequate response to current DMARD.~   "
176361|NCT01256723|"~     The main purpose of this study is to observe the incidence of major adverse cardiac and~     cerebrovascular events (MACCE), target vessel failure (TVF), target vessel revascularization~     (TVR) and stent thrombosis out to 5 years after the procedure in patients who underwent~     percutaneous coronary intervention (PCI) with everolimus-eluting stents for unprotected left~     main coronary artery (ULMCA) disease and lesions involving the ULMCA in Japan. The~     investigators will also establish a method of adjustment to the Japanese version of the~     SYNTAX score by conducting an assessment using the SYNTAX score recently reported in the US~     and Europe as well as the EuroSCORE, and by clarifying the differences of PCI procedures and~     treatment results in Japan with those reported in the US and Europe.~   "
176362|NCT01256710|"~     The purpose of the SJM International, Inc. sponsored Trifecta™ Durability Study, is to~     evaluate the long-term durability of the Trifecta™ valve.~   "
176363|NCT01256697|"~     Retinitis pigmentosa is a genetically determined disease consisting of progressive~     centripetal retinal degeneration starting in the rods outer segments. Its prevalence is~     1:4000 people and is the fourth most common blinding disease in Israel in 2004 [7% of all~     blindness]. The investigators tried to treat a non-progressive form of the disease [Fundus~     Albipunctatus] by oral therapy of the food supplement made from alga Dunaliella bardawil~     composed of approximately 50% 9-cis β-carotene. The alga Dunaliella bardawil accumulates high~     concentration of β -carotene when grown under appropriate conditions. The β -carotene of the~     alga is composed of approximately 50% of all-trans - β carotene and 50% 9-cis β -carotene.~      The 9-cis β -carotene has shown to be a precursor of 9-cis retinoic acid both in-vitro in~     human intestinal mucosa and in-vivo in a ferret, perfuse with 9-cis b-carotene. The night~     vision, as measured objectively by electroretinography (ERG) more than doubled in six~     patients tested. The visual field was also improved significantly.~   "
176364|NCT01256684|"~     The purpose of this Phase III trial is to confirm the efficacy of intravaginal~     dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.~   "
176365|NCT01256671|"~     The purpose of this Phase III trial is to assess the long-term safety of intravaginal~     dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal~     atrophy aged 40 to 75 years.~   "
176366|NCT01256658|"~     This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and~     treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on a~     number of clinical malaria cases in children less than 5 years of age and the improvement of~     hemoglobin levels in the overall population.~   "
176408|NCT01256112|"~     The purpose of this study is to determine whether a nutrition and physical activity education~     program for families of overweight or obese adolescents with Down syndrome is more effective~     when behavioral lifestyle change strategies are added.~   "
176438|NCT01255722|"~     The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol~     (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide~     (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability~     (quality and interpretability of images).~   "
176367|NCT01256645|"~     The aim of this study is to determine, whether a liberal transfusion strategy is helpful to~     liberate patients from prolonged invasive mechanical ventilation.~      Patients who are difficult to wean according to the criteria by Boles et al [1] are limited~     by the capacity of their respiratory muscles.~      Improved oxygen delivery achieved by blood transfusions however is known to decrease the work~     of breathing [2] and thus in theory can improve weaning success [3].~      This study is designed as a prospective, randomized, open labeled blinded End-point~     evaluation to test the hypothesis that a liberal transfusion strategy decreases the time~     needed for weaning.~        1. Boles, JM, J Bion, A Connors, M Herridge, B Marsh, C Melot, R Pearl, H Silverman, M~          Stanchina, A Vieillard-BaronandT Welte, Weaning from mechanical ventilation. Eur Respir~          J, 2007. 29(5): p. 1033.~        2. Schonhofer, B, M Wenzel, M GeibelandD Kohler, Blood transfusion and lung function in~          chronically anemic patients with severe chronic obstructive pulmonary disease. Crit Care~          Med, 1998. 26(11): p. 1824.~        3. Schonhofer, B, H BohrerandD Kohler, Blood transfusion facilitating difficult weaning~          from the ventilator. Anaesthesia, 1998. 53(2): p. 181.~   "
176368|NCT01256632|"~     The primary objective:~      *To measure the difference in the number of Ranibizumab therapies needed in 12 months in the~     Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD) negative~     group.~      Secondary Objective:~        -  To measure the mean change in visual acuity from Baseline to Month 12.~        -  To measure the mean change in central retinal thickness per OCT from Baseline to Month~          12~   "
176369|NCT01256619|"~     The desogestrel (150 mg) in combination with ethinyl estradiol (EE, 30 mg) is known as~     Marvelon in European countries. Previous studies revealed that the Marvelon is good and safe~     for women. As a study from Thailand showed that the Marvelon to be effective and acceptable~     in Thai women. Moreover compared to Caucasian women, the incidences of irregular bleeding and~     side effects were apparently lower in these Asian women . Although Marvelon was used in many~     countries but it's efficacy didn't reported among Iranian women.~   "
176370|NCT01256606|"~     The purpose of this study is to develop and evaluate a blood test for pregnant women for~     detection of fetal aneuploidy.~   "
176371|NCT01256593|"~     The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in~     medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in~     subjects treated with Lyrica will be monitored during the survey period, and whether an~     additional treatment outcome investigation and/or a post-marketing clinical study is required~     in the future will be determined.~   "
176372|NCT01256580|"~     Anti-VEGF therapy has been proven efficacious for the wet (neovascular) form of macular~     degeneration and may be beneficial for the treatment of choroidal neovascularization (CNV)~     due to other causes. The limitation of this type of treatment is the necessity for frequent~     intraocular injections. The purpose of this study is to determine if using anti-VEGF therapy~     in combination with photodynamic therapy can reduce the number of treatments needed with~     monotherapy while achieving similar visual results. There are ongoing multicenter trials~     evaluating combination therapy in patients with wet AMD but no similar trial for patients~     with CNV due to non-AMD causes. Therefore, in this study the investigators will focus on~     patients with CNV not due to AMD.~   "
176373|NCT01256567|"~     The primary objective of this study is to investigate the safety and tolerability of the~     anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in~     Japanese participants with metastatic, or locally advanced breast cancer, with the aim of~     confirming the recommended dose of ramucirumab drug product (DP) in combination with~     docetaxel.~   "
176374|NCT01256554|"~     The goal of this clinical study is to learn the feasibility of using a single session of~     radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural~     spinal cord compression.~   "
176375|NCT01256541|"~     To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas~     levels in patients requiring bowel evacuation, and also to determine the safety, efficacy,~     and patient preference of Kristalose as a bowel evacuant~   "
176376|NCT01256528|"~     The goal of this clinical research study is to learn if delayed-delayed breast reconstruction~     in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and~     result in fewer complications compared to the standard approach (reconstruction that is not~     started until radiation treatment is completed).~   "
176377|NCT01256515|"~     The goal of this study is to assess the immunogenicity of inactivated influenza vaccination~     (IIV) in healthy elderly volunteers aged 50 years and older receiving one of two different~     health management trainings.~   "
176378|NCT01256502|"~     The purpose of the study is to obtain clinical experience with the use of SERI® Surgical~     Scaffold for tissue support and repair in breast reconstruction.~   "
176379|NCT01256489|"~     The proposed study is intended to test the idea, based upon current knowledge of the biology~     and physiology of corneal ulceration in SJS/TENS patients who receive a keratoprosthesis, and~     on the known effects of infliximab on matrix metalloproteinases, that infliximab therapy for~     such patients may reduce the likelihood of corneal ulceration, and hence extend the period of~     prosthesis retention and vision recovery.~   "
176380|NCT01256476|"~     Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg~     daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed~     dyslipidemia.~   "
176423|NCT01255917|"~     This study is to understand the role of nerve growth factor(NGF) and other cytokines in the~     pancreatic fluid of patients with chronic pancreatitis.~      Hypothesis:~        1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is~          not only a mechanical problem~        2. Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is~          variably expressed in different morphological stages of CP and regulates the sensitivity~          of the peptidergic nociceptors and is upregulated in pancreatic inflammation.~   "
176424|NCT01255904|"~     The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal~     dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).~   "
176425|NCT01255891|"~     To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post~     radical prostatectomy patients with high risk pathological features for failure. To determine~     the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and clinical~     progression rate at 5 years.~   "
176381|NCT01256463|"~     The rapid scale-up of HIV care and treatment in resource-limited settings provides the~     opportunity to reach many HIV-positive individuals with prevention messages and interventions~     in care and treatment settings. However, HIV prevention is rarely incorporated into the~     routine care and treatment of people living with HIV, leaving missed opportunities to reach~     patients with critical interventions.~      This study will evaluate an HIV prevention intervention package for health care settings in~     sub-Saharan Africa. The HIV prevention intervention will be delivered to HIV-seropositive~     patients in HIV care and treatment clinics during all routine visits. Health care providers~     (HCPs) will deliver HIV prevention messages on correct and consistent condom use, disclosure~     of serostatus, partner HIV testing, adherence and alcohol reduction. They will also assess~     and treat sexually transmitted infections (STIs) and provide basic contraceptives and safer~     pregnancy counseling.~      Trained lay counselors (LCs) will deliver HIV prevention interventions in the clinics. LCs~     will be persons without medical training, many of whom will be PLHIV, who will be trained to~     provide HIV prevention counseling, promote HIV testing of partners and children (and provide~     HIV testing where allowed by national guidelines), and counsel HIV-positive patients on~     medication adherence and alcohol use.~      The prevention intervention package will be evaluated in HIV clinics in three sub-Saharan~     African countries: Kenya, Namibia, and Tanzania. This project will be a longitudinal~     group-randomized trial with 9 intervention clinics (3 per country) and 9 comparison clinics~     (3 per country). Two hundred patients per clinic (total N = 3600) will be followed for 12~     months. This evaluation will examine the effectiveness of the HIV prevention interventions~     delivered by HCPs and LCs on patient-level outcomes such as risky sexual behavior, disclosure~     of HIV status, partner HIV testing, alcohol use, HIV antiretroviral (ARV) medication~     adherence, STI treatment, pregnancies, and contraceptive use.~      In addition to the patient outcomes, the acceptability of the interventions and materials, as~     well as the feasibility of integrating the interventions into HIV care and treatment~     settings, will be assessed.~      Data will be collected via patient interviews, HCP and LC questionnaires, observations of HCP~     and LC patient visits, patient medical chart review, and review of clinic service data.~   "
176382|NCT01256450|"~     The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal~     film is effective and safe in the treatment of chronic low back pain (CLBP).~   "
176383|NCT01256437|"~     The investigators hypothesized that topical anti-inflammatory treatment could counteract the~     inflammatory reaction induced by EGFR'Is.~   "
176384|NCT01256424|"~     An effective and safe medical therapy would be most welcome to reduce the need for surgical~     interventions and related adverse events and psychological impact on patients with cervical~     cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy~     and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to~     moderate-grade CIN (grade 1-2).~   "
176385|NCT01256411|"~     The purpose of this study is to assess the long-term safety, tolerability and efficacy of~     LCZ696.~   "
176386|NCT01256398|"~     This phase II clinical trial studies how well dasatinib followed by stem cell transplant~     works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by~     stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may~     interfere with the ability of cancer cells to grow and spread. Giving more than one drug~     (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more~     cancer cells.~   "
176387|NCT01256385|"~     This phase II trial studies how well giving temsirolimus together with cetuximab works~     compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and~     neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. It is not yet known whether giving temsirolimus together with cetuximab~     is more effective than giving temsirolimus alone.~   "
176388|NCT01256372|"~     This study investigates the effect of two dose-levels of AP214 on the prevention of (acute)~     kidney injury after cardiac surgery.~   "
176389|NCT01256359|"~     This is a randomised, double-blind placebo controlled phase 2 trial. Patient will be randomly~     assigned 1:1 between 2 treatment arms. They will receive either docetaxel 75mg/m2 IV and~     placebo given bd, or AZD6244 75mg bd daily with docetaxel 75mg/m2 IV. Docetaxel will be~     administered every 3 weeks for a maximum 6 cycles, but AZD6244/placebo may be continued~     beyond this, until disease progression. The objective is to assess whether the combination of~     AZD6244 with docetaxel is worthy of evaluation in a definitive randomised study, with the~     null hypothesis being that the combination has activity similar to that of docetaxel alone in~     this population. After consent has been obtained mutational analysis of tumour BRAF will be~     performed on archival tumour tissue, where this information is not already known, to assess~     eligibility for the study. If there is no archival tissue a fresh biopsy will be requested~     from the patient. A blood sample will also be taken for future genetic analysis. Once taking~     part in the trial patients will need to attend their oncology unit regularly for monitoring~     and the delivery of treatment. Patients will undergo complete physical examination at~     screening, on C1D1, C1D8, C1D15, C2D1, C2D8 and day 1 of every subsequent cycle. Blood for~     haematology, biochemistry and clotting will be taken at each of these visits. A 12 lead ECG~     will be performed at screening . Disease assessment will be by CT scanning using modified~     RECIST criteria after 9 and 18 weeks, then every 3 months until disease progression.~   "
176390|NCT01256346|"~     The goal of this study is to compare the time required for accurate heart rate measurement of~     the preterm newborn when using pulse oximetry versus electrocardiography leads.~   "
176391|NCT01256333|"~     Despite improving in the treatment of acute respiratory distress syndrome (ARDS), this~     affection keep an elevate rate of death. The strategy of mechanical ventilation is more and~     more under definite protocol, following large strength randomized studies. Although, it~     doesn't exist today element allowing to adjust the level of Positive End-Expiratory Pressure~     (PEEP) with improvement in patient's survival.~      The investigators proposed in this study to determinate the level of PEEP adjust to obtain~     the better arterial oxygen transport (TaO2). The investigators going to conduct a~     physiologic, observational, none controlled study. All patients hospitalized in intensive~     care unit of Pontchaillou hospital with ARDS criteria and without specific exclusion criteria~     will be included. Primary objective is to looking for the optimum level of PEEP for TaO2.~   "
176392|NCT01256320|"~     The current research study has the potential to generate data that would provide solid~     clinical endpoints as to the impact of including eggs in a regular diet in individuals with~     peripheral arterial disease. Any one of three potential outcomes may be observed as a result~     of this study, and they are predicted as follows: 1) Egg consumption does not lead to a~     deterioration of indices of cardiovascular health; 2) Egg consumption improves indices of~     cardiovascular health; 3) Egg consumption worsens the indices of cardiovascular health.~   "
176393|NCT01256307|"~     There are two types of treatments depending on the severity of Obstructive Sleep~     Apnea/Hypopnea Syndrome (OSAS): - for the treatment of severe (AHI> 30/h), the standard~     treatment is Continuous Positive Airway Pressure (CPAP). If it proved effective in reducing~     excessive daytime sleepiness and associated cardiovascular risk, compliance of patients 4~     years of treatment falls below 70%. - Treatment of moderate (AHI between 15 and 30/h),~     lifestyle measures, the bracing of mandibular advancement and / or possibly the head and neck~     surgery can be proposed. These treatments include side effects and their effectiveness is~     very controversial.Il therefore seemed interesting to test the impact of physical activity~     through a standardized training program to re personal effort on the development and~     improvement of OSAS patients with a sedentary moderate to severe OSAS (AHI between 15 and 40~     / h) The main assumption is that the ESR could eventually delay the initiation of treatment~     with CPAP in severe OSAS or an alternative therapeutic relevance in the moderate OSAS and~     severe in patients who can not tolerate conventional treatment(CSF). The main objective of~     this biomedical research is to evaluate the effects of a program of REE in ambulatory index~     of hourly apneas / hypopneas (AHI = marker of severity of OSAS) .- objectives specify 2AIR~     effects of REE on the quality of sleep (TxSLP) and daytime symptoms (EDS objective fatigue)~     on the one hand and the other on the metabolism (OV, SM, IR) and markers of LCR~     (inflammation, oxidative stress , endothelial function).~   "
176394|NCT01256294|"~     The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to~     branded tacrolimus (Prograf) in stable renal transplant patients.~   "
176395|NCT01256281|"~     The hypothesis of this study is:~      Femoral nerve blocks can feasibly be performed on patients with Sickle Cell Disease and~     painful crisis in the Emergency Department.~   "
176396|NCT01256268|"~     The purpose of this study is to:~        -  Test the safety of a new investigational drug called MK-8669 (ridaforolimus)~        -  Determine the maximum tolerated dose of MK-8669~        -  Determine the effectiveness of the maximum tolerated dose of MK-8669~   "
176397|NCT01256255|"~     The investigators purpose is to prospectively characterize influenza infections over a 3 year~     period in transplant patients using a registry system. The investigators plan to generate~     robust data on clinical features of upper and lower respiratory disease, antiviral therapy~     and its effects on disease outcome, as well as quantitative virologic data on shedding and~     antiviral resistance. The investigators also will study the long term sequelae of influenza~     infections and look at development of rejection.~   "
176398|NCT01256242|"~     Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary~     surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment~     Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator~     cuff tendon and the humeral head providing further enhanced tendon to bone healing without~     adding any additional safety risk to the patient.~      Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical~     intervention of a torn rotator cuff and to obtain preliminary data to support the rationale~     for a subsequent pivotal clinical trial.~   "
176399|NCT01256229|"~     Children with special needs require complex, individualized therapy to maximize their~     long-term quality of life. One subset of children with special needs includes those with both~     developmental delays and deafness. Currently, there is little compelling evidence supporting~     the idea that cochlear implantation provides benefit to children that don't have the~     cognitive potential to develop normal speech and language.~      We will perform a prospective, randomized clinical trial to answer the question of which~     intervention provides more benefit to this population of children using validated,~     norm-referenced tests.~      Our long-term goal is to develop guidelines that may help when selecting a treatment for~     hearing loss in a child with developmental delays.~      This proposal is significant because children with special needs are deserving of evidence~     upon which to base treatment decision-making, but remain under-represented in the medical~     literature and are often not studied. This research is designed to meet the criteria for the~     National Institutes of Health road map because it will generate this type of objective~     evidence that can directly improve patient care.~   "
176400|NCT01256216|"~     The purpose of the data collection is to document the performance and clinical outcomes of~     the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.~   "
176401|NCT01256203|"~     Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a~     non heated laser. The activation of the drug is done by illuminating abnormal areas using a~     fiber optic device. The fiber optic device is a very fine fiber (like fishing line) that~     permits transmission of light. By itself, porfimer sodium is inactive. However it becomes~     active when it is put in the presence of a light source such as sunlight, very intense indoor~     light, or laser. Therefore, the main risk with this therapy is that the skin will be more~     sensitive to light, and this sensibility can last up to 90 days. The skin reaction is similar~     to sunburn and is called phototoxicity.~      To date, no product on the market has shown protection against visible light, and therefore,~     no product has been demonstrated to protect against the skin phototoxicity to visible light.~     A sunscreen sold under the brand name Solar Protection Formula® SPF 60 in the United States~     contains ingredients that provide maximum ultraviolet (UV) protection, as well as a~     formulation that could provide visible light protection. The product could potentially~     prevent the skin phototoxicity due to visible light, the most frequently reported side effect~     in patients receiving PDT with porfimer sodium. Therefore, this study is designed to assess~     the efficacy of topical application of Solar Protection Formula® SPF 60 as skin protector~     against visible light-induced skin redness and swelling following injection of porfimer~     sodium. It will involve 17 to 20 human subjects in the United States for whom PDT with~     porfimer sodium is planned for the treatment of high-grade dysplasia in Barrett's esophagus~     (pre-cancerous change in the food pipe tissue), lung cancer, or cancer of the esophagus (food~     pipe).~   "
176402|NCT01256190|"~     A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and~     safety trial in subjects undergoing open liver resection surgery. The study will enroll 42~     eligible subjects and be conducted at 4 sites in the Netherlands.~   "
176403|NCT01256177|"~     The primary objective of this study is to evaluate the superior efficacy of quetiapine~     extended release(XR) mono-therapy, administered once daily compared to placebo, in the~     treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder~   "
176409|NCT01256099|"~     This study includes two sub-trials.~      In trial 1 patients suffering from insomnia but not meeting the criteria for depression are~     randomised to either therapist guided Internet-based CBT for insomnia or to a control group~     with a non-guided, brief self-help program that acts as a placebo control. The primary~     purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment~     and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the~     costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive~     effect on future depressive episodes. Recruitment is done through mass media and includes all~     regions of Sweden. Initial assessment based on questionnaires and telephone interviews.~      Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done~     between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each~     respective treatment's effect on both insomnia and depression. The patients need for further~     treatment after the initial one will be measured and used as a secondary outcome. Recruitment~     is done through mass media but only citizens in the Stockholm area are included since the~     initial assessment are based on both questionnaires and telephone interviews as well as a~     visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.~      Both trials will include health economic data and analysis. For the longer follow-up periods~     (1 and 3 years), registers will be used to analyse consumption of sleep medication and~     antidepressants as well as general health care utilization.~   "
176410|NCT01256086|"~     The purpose of this study is to estimate the relative potency for bronchoprotective effect of~     formoterol Novolizer 12 µg (test) compared to formoterol Aerolizer 12 µg (reference).~   "
176411|NCT01256073|"~     The trial is a multi-centre, open-label, safety and tolerability extension trial to the~     IPH2101-101 (previously NN1975-1733) first human dose trial completed with a larger subject~     pool at an optimal dose level. The trial is conducted in elderly Acute Myeloid Leukemia (AML)~     patients over the age of 60 years, in complete remission, and who are not eligible for~     allogeneic stem-cell transplantation. The dose given to the individual patient will be the~     same as the patient received in the single dose trial IPH2101-101 and 1 mg/kg or 2 mg/kg for~     the 12 patients in an additional cohort.~   "
176412|NCT01256060|"~     Extensive data has been accumulated to suggest that central release of oxytocin is important~     for social cognition and function, as well as likely involved in anxiety modulation and~     repetitive behaviors. The principal investigators of this study have previously documented:~     1) an association between Autism Spectrum Disorder and a single nuclear polymorphism of the~     oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme~     immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in~     the treatment of social deficits and repetitive behaviors in adults with autism. A medication~     treatment targeting the core deficits of Autism Spectrum Disorder in childhood is highly~     valuable because it could influence the developmental trajectory and make further~     psychosocial interventions possible. In this context, we propose a small dose finding study~     to confirm that the dose used in the adult study is not more than the maximum tolerated dose~     in youth. `~   "
176413|NCT01256047|"~     The purpose of this study is to determine whether preoperative immunonutrition is effective~     on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.~   "
176414|NCT01256034|"~     The purpose of this study is to determine whether preoperative immunonutrition is effective~     on infectious complication and Th1/Th2 differentiation in patients with~     pancreaticoduodenectomy.~   "
176415|NCT01256021|"~     The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the~     treatment of children with cerebral palsy.~   "
176416|NCT01256008|"~     The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on~     depression and anxiety in breast cancer patients.~   "
176417|NCT01255995|"~     -  The purpose of this study is to determine the natural course of IOL in PXF,~        -  To demonstrate use of a clinical grading system for PXF,~        -  To strategize a way to prevent IOL dislocation, subluxation post operatively,~        -  To demonstrate intraoperative and long-term post-operative complications associated with~          phaco and PXF~        -  To suggest evidence-based ways to minimize these complications, by using capsular~          tension rings (CTR), specific IOL material or size~   "
176418|NCT01255982|"~     This study aims to study prospectively for 8 months a sample of bipolar patients with acute~     depressive episode in order to identify that factors associated with functional impairment,~     with especial attention to the presence of subsyndromal symptoms beyond the acute phase.~   "
176419|NCT01255969|"~     To evaluate if a model of intervention based on a low-grade physical program prescribed in~     the dialysis centre and performed at home can modify the functional capacity and quality of~     life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular~     events and vascular access failure in dialysis patients.~   "
176420|NCT01255956|"~     The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon~     catheter in the treatment of restenosis in bare metal stent.~   "
176421|NCT01255943|"~     The purpose of this study is to implement strategies for improved efficiency and waste~     reduction (Toyota Lean) and positive deviance, a social behavioral change process,~     utilizing frontline healthcare personnel to reduce infection bloodstream infection and MRSA~     infection in outpatient dialysis care. In two outpatient dialysis units, dialysis unit~     healthcare staff will be educated in Toyota lean techniques and conduct periodic discovery~     and action dialogues to identify and implement care process changes to reduce infection.~     Outcomes to be monitored will include incidence of bloodstream infections and MRSA infections~     of all types. Data will be assessed at quarterly intervals using interrupted time series~     analysis.~   "
176422|NCT01255930|"~     The aim of this study is to evaluate placenta maturity by the sonographic textures.The~     evaluation of placenta maturity by the sonographic textures is related to anticipative~     pregnancy and actual pregnancy . By analyzing this theory, the investigators want to bring up~     another objective and accurate analysis method in order to provide information for the~     evaluation of clinical trials.~   "
176437|NCT01255735|"~     The primary objective of this study is to determine the impact of voice therapy on~     voice-related quality of life in children age 6-10 years old with apparent vocal fold~     nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument~     (PVRQOL)administered 4 weeks after completion of voice therapy.~   "
176426|NCT01255878|"~     Sleep bruxism (SB) is defined as a stereotyped movement disorder characterized by grinding~     or clenching of the teeth during sleep usually associated with sleep arousal. It might lead~     to abrasive tooth wear, hypermobility of teeth, tooth hypersensitivity, hypertrophy of the~     masticatory muscles and pain in the masticatory muscles.~      Diagnostic procedures include clinical evaluation, ambulatory monitoring sleep laboratory~     investigations and others. The clinical approach comprises the patient's history, orofacial~     examination, and tooth wear classification.~      There is no specific treatment for bruxism. Management of SB comprises psychological,~     orodental and pharmacological strategies.Orodental therapies, including soft vinyl mouth~     guards or stabilization bite splints, probably function more like protectors of the orofacial~     structures rather than actually diminishing bruxism.Drug treatment of sleep bruxism is~     controversial since different treatment strategies have resulted in suppression or~     exacerbation of this condition.~      Based on the current data, central primary efferents are the major drivers of bruxism.~     Therefore centrally acting agents such as antiepileptic drugs which also affect the sleep~     structure, might be effective on SB.~      In a case report of bruxism, anxiety and tremor, the authors suggested that anti-convulsant~     Gabapentine may be a useful treatment for patients with antidepressant-induced bruxism.~     However in the absence of definitive evidence, the appropiate treatment of SB is still a~     matter of debate.~      The objective of the present study was to compare the treatment efficacy of occlusal~     stabilization splint and Gabapentine on SB, using polysomnographically determined outcome~     measures for the quantification of sleep bruxism.~   "
176427|NCT01255865|"~     The purpose of this trial is the generation of clinical data required for a 510(k) submission~     to the FDA. The trial design reflects elements desired by the FDA. The trial is designed to~     satisfy the relevant requirements of the FDA Guidance (March 1993) on the content of~     premarket notification [510(k)] submissions for clinical electronic thermometers and ISO/IEC~     80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety~     and essential performance of clinical thermometers for body temperature measurement.~   "
176428|NCT01255852|"~     Severe intracranial atherosclerosis with concomitant stenosis is responsible for~     approximately 10% of all strokes. Retrospective studies have indicated that up to 50% of~     patients with a recently symptomatic intracranial stenosis experience recurrent ischemic~     events. Due to the high stroke risk, patients with high grade 70% symptomatic intracranial~     stenosis represent the main target group for endovascular treatment. Atorvastatin is widely~     used in the treatment of hyperlipidemia, especially after acute myocardial infarction.~     High-dose atorvastatin has been known to stop the progression of atherosclerosis and to~     decrease the levels of inflammatory markers. Several recent clinical trials have proved~     atorvastatin can reduce restenosis after stent implantation in coronary artery. But the~     feasibility of atorvastatin in preventing restenosis in patients with intracranial stenting~     has not been evaluated.The purpose of this prospective, randomized, single-blinded trial is~     to evaluate the effect of atorvastatin 80 mg daily in preventing restenosis and related~     vascular events in patients with intracranial stent implantation.~   "
176429|NCT01255839|"~     The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable~     cervices is well-established1. There are, however, potential side effects to prostaglandins,~     in particular the risk of uterine hypertonicity which may affect fetal outcome. In theory a~     mechanical ripening based on dilatation of the cervix as well as induction of production of~     endogenous prostaglandin has potentially less influence on the fetal outcome but a Cochrane~     review from 2001 scrutinized studies on mechanical ripening versus placebo/no treatment or~     prostaglandin E2. They conclude there is insufficient data to evaluate the effectiveness in~     terms of likelihood of vaginal delivery in 24 hours, and emphasise the need for large sample~     size studies and substantive outcomes. Two later randomised studies compared mechanical~     ripening to PGE2 and found discrepant results regarding time from induction to delivery.~      The primary purpose of the present study was in a randomized design to compare the efficacy~     of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) on induction of labour,~     duration of birth and fetal outcome. Secondary analyses were to evaluate the results for~     various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm~     birth and intra uterine growth restriction.~   "
176430|NCT01255826|"~     The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as~     delivery room ventilatory management for preterm neonates at risk of respiratory distress~     syndrome in reducing their need for mechanical ventilation and ameliorating lung injury~     without inducing adverse effects compared with intermittent bag and mask ventilation.~   "
176431|NCT01255813|"~     The purpose of the proposed clinical study is to evaluate the use of an implanted~     Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of~     the pain associated with cluster headaches.~   "
176432|NCT01255800|"~     This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926 in~     combination with cetuximab in patients with advanced head and neck cancer.~   "
176433|NCT01255787|"~     The purpose of this study is to assess the efficacy and safety of multiple doses of~     vortioxetine, once daily (QD), in participants with major depressive disorder.~   "
176434|NCT01255774|"~     The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular~     Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular (wet)~     Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF levels~     in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been shown to~     maintain or improve vision in wet AMD. Since the treatments do not halt the loss of visual~     acuity in wet AMD, it is important to accurately measure anatomic response to treatments~     thereby enhancing the ability to understand patterns of response and predict the necessity~     for continued therapy.~   "
176435|NCT01255761|"~     Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a~     physician completed assessment (CDAI) to predict treatment success with subjects with~     moderate to severe rheumatoid arthritis~   "
176436|NCT01255748|"~     The purpose of this research study is to collect and analyze information from patients being~     treated with various forms of radiation therapy.~   "
176461|NCT01255423|"~     The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1%~     compared with placebo applied four times a day in subjects with acute ankle sprains under~     'in-use' conditions, in particular with regard to pain relief.~   "
176439|NCT01255709|"~     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine~     Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a~     stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the~     administered drug from the endogenous epinephrine, in healthy male and female adult~     volunteers.~   "
176440|NCT01255696|"~     A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.~   "
176441|NCT01255683|"~     Despite the common use of oral steroids in the management of chronic rhinosinusitis (CRS),~     the natural history and efficacy of this treatment modality has not been fully elucidated.~     Specifically, patients who have undergone prior ESS and have recalcitrant CRS, the natural~     history of endoscopic improvement and quality of life (QoL) outcomes, following an oral~     steroid taper, is poorly defined. The purpose of this non-randomized single-arm clinical~     trial is to evaluate the effectiveness of an oral steroid taper in improving endoscopic~     grading, QoL, and olfactory function as well as defining the duration of improvement, in~     patients with recalcitrant CRS with prior endoscopic sinus surgery (ESS).~   "
176442|NCT01255670|"~     Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are~     required in addition to abscess drainage we perform a prospective, double blind,~     placebo-controlled, randomised study on 200 adult patients with peritonsillar abscess. 100~     patients are given penicillin and metronidazole and 100 patients get penicillin and placebo.~     Recovery and recurrence and analyzed.~   "
176443|NCT01255657|"~     This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and~     evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.~   "
176444|NCT01255644|"~     Chronic lymphocytic leukemia (CLL) is increasingly believed to be closely related to chronic~     stimulation of healthy B-cells. Identification of antigen(s) are relevant for the stimulation~     of CLL precursor cells is therefore of high interest. The investigators found recently~     evidence that a herpes virus is involved in this process of stimulation. Consequently,~     elimination of the antigenic stimulation of leukemic cells by this herpes virus may be~     expected to reduce or even inhibit propagation of leukemic cells. The investigators~     hypothesize that inhibition of CMV replication by a short course of antiviral treatment may~     reduce significantly proliferation rates of leukemic cells. To test this hypothesis, the~     investigators will treat 20 CLL patients with an antiviral drug for 3 months in a~     proof-of-concept clinical trial and leukemic cell counts measured before and after antiviral~     treatment. Antiviral treatment has the potential to treat the disease at its origin and~     therefore more efficiently than conventional chemotherapeutic regimens.~   "
176445|NCT01255631|"~     The most important prognostic indicator for the breast cancer patient is the axillary lymph~     node status. With the introduction of the sentinel lymph node biopsy, many women were spared~     the morbidity of a full axillary lymph node dissection(ALND) while having the axillary nodes~     assessed with a low false negative rate. Approximately 30% of women who undergo ALND~     experience shoulder/arm morbidity including numbness, pain, weakness and decreased range of~     motion. In addition, the sentinel lymph node dissection (SLND) held the promise that women~     with early stage breast cancer would be able to avoid the dreaded morbidity associated with~     axillary lymph node dissections including lymphedema, decreased range of motion and pain.~     Since the adoption of SLN, numerous papers have documented that SLN is superior to ALND.~     However, patients who undergo SLN still have a significant amount of pain with this~     procedure. There are few published studies which objectively assess the subjective and~     objective symptoms of SLND.~      Pulsed electromagnetic fields (PEMF) have been shown to be effective in the treatment of~     fractures and spinal fusion, relief of pain in acute sprains and whiplash injuries,~     improvement of skin blood flow, healing of venous stasis ulcers, and reduction of~     postmastectomy lymphedema. Indeed, radiofrequency PEMF devices are FDA approved for pain and~     edema relief. PEMF devices are economical and disposable, and can be incorporated~     unobtrusively in standard post-op dressings. We have recently reported, in a double-blind,~     placebo-controlled study on breast reduction, that post-op PEMF therapy produced a~     significant decrease in pain and pain medication use, along with a concomitant decrease in~     IL1-beta in the wound bed.1 The current pilot study will be designed to determine if PEMF~     treatment, given in addition to standard of care, can reduce post-operative discomfort and~     morbidity after lumpectomy and SLND, or lumpectomy and ALND. Lumpectomy and ALND/SLND~     patients enrolled in the double-blind, placebo-controlled study will undergo standard~     surgery, but will be randomized to one of two groups: the treatment group with a PEMF coil~     placed around the arm and the control group with a coil that delivers no PMF. We expect~     postoperative pain to be reduced in the PEMF-treated patients as well as improved arm~     mobility and strength. The use of PEMF might reduce the need for narcotic pain medications~     and their side effects of sedation, nausea, and vomiting. It may also reduce costs related to~     arm morbidity.~   "
176446|NCT01255618|"~     Near infrared spectrophotometry (NIRS) offers the possibility of noninvasive and continuous~     bedside investigation of cerebral , renal, mesenteric and peripheric oxygenation and~     hemodynamics, and changes in newborn period.The aim of the present study is to investigate~     cerebral oxygenation with NIRS method in polycythaemic infants who underwent partial exchange~     transfusion.~   "
176447|NCT01255605|"~     The purpose of this is to determine the impact of intermittent preventive treatment (IPT)~     with sulfadoxine-pyrimethamine (SP) on the morbidities associated with malaria in pregnant~     women and newborns in rural peri-urban areas of Bobo-Dioulasso, 5 years after its~     implemented.~   "
176448|NCT01255592|"~     The purpose of this study is to investigate the effect of AZD5069 in patients with~     bronchiectasis.~   "
176449|NCT01255579|"~     New formulations of extrafine particles of long acting beta-2 agonists+inhaled~     corticosteroids (LABA+ICS) are able to reach more peripheral regions of the lung.~      Objectives.The aim of this study was to assess the effect on small airways obstruction of~     long-term treatments with two different LABA+ICS combinations in asthma.~      Patients and methods.Ten subjects with moderate persistent asthma were enrolled. After a~     4-week washout they were treated in a randomized cross-over design for 24 weeks with~     formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d. (FB) or salmeterol 50 mcg and~     fluticasone 250 mcg (diskus) b.i.d. (SF). At baseline and at the end of each period subjects~     underwent Asthma Control Test (ACT) and Pulmonary Function Testing. The N2 phase III slope~     and closing volume (CV) during single breath washout test, and DElta(Heliox-air)MEF50% were~     measured to assess changes on peripheral airways function.~   "
176450|NCT01255566|"~     This investigation is a prospective, multi-institutional cohort study comparing the~     differences in health-related quality-of-life (HRQoL) improvements between subjects electing~     continued medical management for chronic rhinosinusitis and those electing medical management~     plus surgical intervention.~      Our hypothesis is 3 fold: 1. That patients electing continued medical management will have~     less disease severity as measured by CT and baseline HRQoL scores, 2. Patients undergoing~     medical management plus ESS for chronic rhinosinusitis will experience a larger improvement~     in health related quality of life (HRQoL)compared to patients electing medical management~     alone, and 3. Patients undergoing medical management plus ESS for chronic rhinosinusitis will~     use fewer antibiotics, systemic steroids, and miss fewer days of work/school compared to~     patients electing medical management alone.~   "
176451|NCT01255553|"~     This is a pilot study to determine if partial breast irradiation (PBI) limited to the region~     of the tumor bed following lumpectomy in patients screened with MRI provides historically~     similar rates of local failure, limited acute skin toxicity, late complications and cosmetic~     outcome when compared to patients treated with standard 3D-CRT to the whole breast.~   "
176452|NCT01255540|"~     The rationale of the present clinical trial is to study whether an invasive strategy in~     clinical stable patients over 80 years with NSTEMI/UAP may improve rates of death,~     reinfarction, stroke, need of urgent revascularisation, myocardial function and quality of~     life. The invasive approach involves coronary angiography with immediate evaluation for three~     different treatment options; 1. Percutaneous coronary intervention (PCI), 2. Coronary artery~     bypass graft (CABG) or 3. medical treatment. Clinical practice shows that older patients are~     commonly treated less vigorously than younger patients and the present guidelines are based~     on a considerably younger population.~   "
176453|NCT01255527|"~     Despite the advantages of autologous stem cell transplantation (ASCT) over conventional~     chemotherapy,1,2 the results of high-dose chemoradiotherapy in multiple myeloma (MM) are~     still unsatisfactory with a 6-year event free survival (EFS) of only 24%.~      Based on existing data, bortezomib-containing regimens are currently accepted at many centers~     as an induction treatment option for patients with symptomatic MM, particularly if it is~     planned to offer subsequent high-dose therapy with ASCT. So we will use bortezomib-containing~     regimens as induction prior to this novel conditioning regimen. The objective of the present~     study is to compare the toxicity and therapeutic efficacy of a new high-dose regimen using~     dose-escalation of BOR, BU and MEL for ASCT in the Korean patients with MM. The patients~     should be treated with bortezomib-containing regimens as an induction therapy before ASCT. We~     will specifically analyze (i) the efficacy of the conditioning regimen in improving the~     pre-ASCT status, response rate (ii) engraftment and transplant-related mortality (TRM) and~     (iii) the impact on survival including progression-free survival (PFS) and overall survival~     (OS).~      Triple combination of conditioning will enhance the response rate after ASCT, and will~     improve not only PFS, but also OS. We think that data from this study may further strengthen~     feasibility of BOR in conditioning prior to ASCT.~   "
176454|NCT01255514|"~     Complete Response (CR) plus near CR rate of VAD (Vincristine, Adriamycin, Dexamethasone)~     induction chemotherapy followed by ASCT in patients with newly diagnosed MM was about 50% and~     CR plus near CR rate of PAD (Bortezomib, Adriamycin, Dexamethasone) induction chemotherapy~     followed by ASCT in patients with newly diagnosed MM was about 60%. If the CR with near CR~     rate of sequential high-dose dexamethasone and response adopted PAD or VAD induction~     chemotherapy followed by ASCT is more than 60%, this combination will be accepted as active~     regimen that may be worth for investigating in phase III trial. But, if the CR with near CR~     rate of this regimen is lower than 50%, this has not a merit than VAD induction chemotherapy.~      Based upon the above assumption, this trial was designed by using Simon's optimal two-stage~     testing procedure. Assuming a target level of interest, p1=0.6, and a lower activity level,~     p0=0.5. Initially 61 patients will be accrued. If 33 or more CR + near CR rate were observed,~     the trial will be continued. Accrual will be planned to a total of 190 patients. If total 106~     or more patients were assessed as CR with near CR, sequential high-dose dexamethasone and~     response adopted PAD or VAD induction chemotherapy regimen will be accepted as active~     regimen. This design provides probability 0.05 of accepting drugs worse than p0 and~     probability 0.20 of rejecting drugs better than p1. If we assume that drop-out rate is 10%,~     total accrual patient will be 210.~      Patient characteristics and toxicity will be evaluated by descriptive methods. Progression~     free survival and overall survival (median value, 95% confidence interval) will be calculated~     by Kaplan-Meier method.~   "
176455|NCT01255501|"~     The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic~     profiles of a novel therapeutic drug when administered to healthy volunteers.~   "
176456|NCT01255488|"~     To better understand the extent to which family nurse practitioners (FNPs) might use research~     abstracts in shaping their clinical decision-making under simulated conditions. A secondary~     point is to examine if and how FNPs might use full-text manuscripts (associated with the~     abstracts) if made available to them.~   "
176457|NCT01255475|"~     Previous studies have demonstrated a direct association between blood pressure level and~     cardiovascular risk. However in patients with heart failure this association is considered~     controversial. The aim of this study is to evaluate the effect of the reduction of blood~     pressure in patients with heart failure. The investigators will examine the effects of this~     intervention over mortality, quality of life, and cardiac function.~   "
176458|NCT01255462|"~     This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal~     LFG316 in patients with advanced age-related macular degeneration.~   "
176459|NCT01255449|"~     The aim of the present study will be to test the hypothesis that changes in within-breath~     total respiratory input impedance (Zrs) may provide an early evidence of obliterative~     bronchiolitis after allogeneic hematopoietic stem cell transplantation (HSCT). Before and~     after HSCT, Zrs will be measured by a modified forced oscillation technique (FOT) during~     spontaneous breathing both at baseline and 30 min after albuterol inhalation . Such technique~     may be particularly sensitive to small changes in lung mechanics observed in the early stages~     of peripheral airflow obstruction.~   "
176460|NCT01255436|"~     Objective: To test the primary hypothesis that SMS text messages delivered to patients via~     mobile phone can improve blood pressure within 12 weeks compared to usual care~      Design: Parallel group, randomized, controlled trial; the patient is the unit of~     randomization~      Setting: General Medicine Outpatient Continuity Clinic of the Philippine General Hospital and~     Private Outpatient Clinics near the Philippine General Hospital~      Patients: Ambulatory men and women aged 19 years and older (N=700) with a diagnosis of~     essential hypertension, on maintenance blood pressure-lowering medications, who have daily~     access to a mobile phone in the household and know or live with someone who knows how to~     retrieve, read and reply to text messages using a mobile phone~      Intervention: SMS text messages delivered twice a week for 12 weeks, which aim to 1) provide~     information regarding hypertension; 2) remind patients to take their medications.~      Main Outcome Measure: The primary outcomes are the mean change in systolic and diastolic~     blood pressures at the end of 12 weeks. The secondary outcomes are improvement in blood~     pressure control rate and medication adherence.~   "
176462|NCT01255410|"~     People who are infected with human metapneumovirus (HMPV) may develop upper and lower~     respiratory illnesses. Children are particularly sensitive to HMPV infection. This study will~     evaluate the safety and immune response of an HMPV vaccine in healthy adults,~     HMPV-seropositive children, and HMPV-seronegative infants and children.~   "
176463|NCT01255397|"~     The purpose of this experiment is to test the feasibility of a minimally interventionist~     protocol for young couples with male factor infertility, which addresses the cause of~     infertility for these couples which is the inability of the sperm to fertilize the~     egg.Ultrasound monitoring of natural follicular development utilizing rFSH, GnRH antagonist~     and rHCG only for the final maturation. Single follicle aspiration and IUI or IVF/ICSI based~     on sperm charcteristics on the day of fertilization. Fertilized eggs transfered to the uterus~     on the same day as the aspiration.~   "
176464|NCT01255384|"~     Pregestational diabetes (PGD) during pregnancy may be associated with an increased rate of~     spontaneous abortions, intrauterine death and congenital anomalies among the offspring.~     Although the prevalence of congenital anomalies among the offspring of diabetic mothers is~     reduced as a result of the improvement of the glycemic control in the early pregnancy, the~     rate of congenital anomalies is increased and there seems to be an increased rate of~     neurodevelopmental disorders including some fine and gross motor deficits as well as~     increased rate of inattention and/or hyperactivity. In gestational diabetes, that develops in~     the second half of pregnancy (past the period of major organogenesis), there seems to be no~     increase in the rate of major congenital anomalies but there are some developmental disorders~     in the offspring.~      The exposure of the developing embryo and fetus to diabetic environment (i.e. hyperglycemia,~     hyperketonemia ext), is known to cause increased oxidative stress and significant changes in~     gene expression as observed in several experimental diabetic models. We hypothesize that~     diabetic environment may also cause long lasting epigenetic changes. It is therefore our~     purpose to evaluate these possible epigenetic changes and correlate their presence with the~     degree and time of onset of diabetes, (i.e. whether from the beginning as in PGD or in the~     second half of pregnancy as in GD), the degree of oxidative stress and with the~     neurodevelopmental outcome of the offspring. Diabetic pregnancies will be compared to a~     similar number of normal pregnancies in all parameters studied.~   "
176465|NCT01255371|"~     In the well recognized context of HIV infection chronicity, it is now crucial to identify and~     evaluate effective, well tolerated and affordable second line regimen in resources limited~     countries where patients often change treatment after a long period of viral replication~     while on first line regimen.~      This multicentre international, randomized, non-blinded phase III trial aim to demonstrate~     the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily~     intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily~     intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level~     (between 1000 and 5000 copies/mL versus > 5000 copies/mL) at inclusion, this trial will also~     allow to evaluate the optimum moment for instituting the second-line treatment.~   "
176466|NCT01255358|"~     Multi-centre, single arm, open label, 6 months, phase II study to evaluate the effect of~     Ery-Dex in improving Central Nervous System (CNS) symptoms in patients with Ataxia~     Teleangiectasia (AT). The study consists of a screening period (max duration of 30 days) and~     a treatment period (duration 6 months).~   "
176467|NCT01255345|"~     The purpose of this study is to investigate the frequency and severity of chronic pelvic pain~     (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4~     million), Denmark, in relation to selected factors, such as basic demographic and clinical~     factors, health related quality of life, physical activity and abnormal muscular findings in~     the pelvic area.~   "
176468|NCT01255332|"~     We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st~     line treatment of immune thrombocytopenic purpura (ITP) patients with moderate~     thrombocytopenia.~      If this eradication treatment is revealed effective on ITP patients with more than 30X109/L~     of platelet, it would be valuable treatment especially for young ITP patients with mild to~     moderate thrombocytopenia.~   "
176469|NCT01255319|"~     To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide,~     fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell~     transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS).~   "
176470|NCT01255306|"~     The aim of the study is to evaluate the influence of silicone oil on thickness of the retinal~     nerve fiber layer by using optical coherence tomography (OCT) in patients following pars~     plana vitrectomy.~   "
176471|NCT01255293|"~     The purpose of this study is to assess the retinal redetachment rates with 1000 centistoke~     versus 5000 centistoke silicone oil tamponade for repair of complex retinal detachments.~   "
176472|NCT01255280|"~     The purpose of this study is to research a new behavioral treatment to reduce sexual~     risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal~     meth), and are at risk for HIV acquisition. This study proposes using a treatment based on~     our original pilot study that incorporates risk reduction and behavioral activation therapy.~     In order to help learn what types of treatment programs best help individuals who abuse~     crystal meth and engage in sexual risk-taking, we will compare our treatment to a control~     group. The treatment group will receive therapy incorporating behavioral risk reduction~     counseling with behavioral activation therapy to treat depression, helping individuals~     reengage in their life. The control group will receive the risk reduction counseling without~     the behavioral activation therapy. The current study hopes to explore the efficacy of this~     previous developed treatment in a two-arm pilot randomized controlled trial.~   "
176473|NCT01255267|"~     In this study, we evaluate the acute coronary syndrome patients to see if there is~     correlation between platelet activity, genetic polymorphism (CYP2C19 and ABCB1), serum~     adipokines level, and Clopidogrel responsiveness.~   "
176474|NCT01255254|"~     The aim of the study is to evaluate the effect of non-surgical periodontal therapy,~     consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the~     metabolic control of chronic periodontitis patients with type II diabetes mellitus.~   "
176492|NCT01255020|"~     The prospective, double blind randomized, parallel control, and multi-center clinical trial~     will evaluate the safety and efficacy of α-keto acid with restricted protein diet on~     protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD)~     patients.~   "
176475|NCT01255241|"~     Lower Limb Deformities (LLDF) is a rather common infirmity among children. LLDF may result~     from various conditions such as trauma, tumors, infection, and dysplasia, congenital and~     metabolic abnormalities. It is assumed that correction of deformities by surgical procedure~     will improve ambulation and reduce energy expenditure.~      This prospective study will document the process of establishing the initial localization and~     magnitude of deformity through physical and radiological examination, kinetic and kinematical~     parameters, and measuring energy expenditure. The study will also document the type of~     surgical intervention undertaken to correct the deformity. Following a recovery from surgery,~     children's ambulation will be assessed again, by physical and radiological examination, by~     kinetic and kinematical parameters, and by measuring energy expenditure. A third series of~     exams will be performed four months later.~      It is expected that the surgical intervention will improve ambulation and reduce energy~     expenditure. This study aims at establishing a model enabling to assess ambulation and energy~     expenditure before and after surgical intervention. The results of the study may have~     practical implications on the decision and type of surgical procedures.~   "
176476|NCT01255228|"~     Excessive body weight and obesity have reached epidemic proportions over the last few~     decades, which may cause many chronic diseases. Maintaining a healthy life style could~     decrease the risk for obesity, metabolic syndrome and cardiovascular disease. The study aimed~     to evaluate long-term low glycemic index (GI) diet intervention on lipid profile, body~     composition and the mechanism of obese women. The pilot study will recruit twenty healthy~     subjects, and served test food to determine low GI food. In the experiment period, twenty~     women age from 20-50 years will be recruited. To be included in the study, subjects should~     have a BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline > 80 cm). Before~     dietary intervention, participants will receive food choice table and dietary questionnaires~     to record their dietary intake.~      The study will be a randomized, crossover, controlled clinical trails. The experiment period~     have six weeks, each participants will provide low GI diet (lunch and dinner). On the 0, 3, 6~     week, subjects will measurement their body composition (body weight, body mass, waist and hip~     circumferences) and collect fasting blood samples to analysis the lipid profile, free fatty~     acid, blood sugar, insulin, adiponectin, leptin and fatty acid synthesis enzymes. Statistical~     analysis will be performed by paired t-test. The study expect that long-term low GI diet~     intervention have beneficial effects on regulate body composition of obese women.~   "
176477|NCT01255215|"~     Despite the use of highly effective anti-malarial medications, 10-30% of African children~     with severe malaria will die, underscoring the need for adjunctive therapies that can be~     applied in endemic areas. A clinical trial of adjunctive inhaled nitric oxide (iNO) in severe~     malaria is warranted on the basis of firm proof of concept from animal studies and a human~     study using the NO donor L-arginine, together with evidence of safety from clinical~     experience and trials of iNO for other conditions. Our objective is to determine whether~     supplemental iNO (80 ppm) in addition to Ugandan Standard of Care treatment reduces levels of~     Angiopoietin-2 (Ang-2), a quantitative biomarker of malaria severity, in children with severe~     malaria compared to Standard of Care treatment alone. We will conduct a randomized~     placebo-controlled trial among children 1-10 years of age admitted to Jinja Hospital (Uganda)~     with severe malaria to test the efficacy of inhaled nitric oxide in severe malaria.~   "
176478|NCT01255202|"~     The purpose of this study is to finout whetere uterinae artery flow , PP13 and endogolin~     levels in the serum and kongo red in the urine can predict preeclamsia toxemia in twin~     pregnancies.~   "
176479|NCT01255189|"~     Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside~     investigation of cerebral oxygenation in newborn infants. Using this technique we~     investigated the effect of positional changes on cerebral oxygenation in preterm infants.~   "
176480|NCT01255176|"~     It gave a clinical trial which will be included in the 60 infants, aged up to 24 months,~     diagnosed with congenital's population will be divided by simple randomization into three~     groups: 20 infants in the intervention group, 20 infants in the control group, not receive~     the RTA technique and another 20 infants in a placebo group, we just get the support manual~     therapist for 5 minutes. Initially the data will be collected cardio heart rate, respiratory~     rate and oxygen saturation. Then the researcher will apply three specific rating scales,~     based on clinical presentation and behavior of infants. Hypothesis: The RTA improves~     cardiorespiratory parameters and reduces signs of discomfort and pain of infants with~     congenital heart acyanogenic.~   "
176481|NCT01255163|"~     Background:~      Exendin-4 (or Exenatide) is a medication currently used to treat diabetes that has shown~     promising results in animal and cellular models of Alzheimer's disease. It is possible that~     Exendin-4 may be a treatment for Alzheimer's disease, which involves the gradual~     deterioration and death of neurons. Researchers are interested in studying the safety and~     comparing the effects of Exendin-4 with placebo on cognitive performance, clinical~     progression of dementia, various chemicals measured in blood and cerebrospinal fluid, and~     brain MRI, in individuals with early-stage Alzheimer's disease or mild cognitive impairment.~      Objectives:~      To determine the safety and tolerability of twice daily administration of Exendin-4, as well~     as to acquire preliminary evidence for effects on cognitive performance, clinical progression~     of dementia, various chemicals measured in blood and cerebrospinal fluid, and brain MRI, in~     individuals with early-stage Alzheimer's disease or mild cognitive impairment.~      Eligibility:~      Individuals at least 60 years of age who have objective evidence of early-stage Alzheimer's~     disease or mild cognitive impairment in screening testing.~      Design:~        -  Participants will be screened.~        -  Following the telephone screening, two in-person screening visits to determine~          eligibility.~        -  The screening visit will involve a medical history and neurological examination, tests~          of memory and cognition, a lumbar puncture, collection of blood and saliva samples, and~          brain Magnetic Resonance Imagine (MRI) studies. Participants will be required to appoint~          a Durable Power of Attorney for research and medical care during this protocol.~        -  Eligible participants will be divided into two groups (double-blind randomization). One~          group will receive Exendin-4 SC twice daily, and the other will receive a placebo.~          Participants will keep a medication diary and will be scheduled for additional study~          visits 1 and 2 weeks after the start of the treatment.~        -  Participants will have regular followup visits with blood tests, cognitive tests,~          imaging studies, and other examinations 6, 12, and 18 months after the start of the~          treatment. Another lumbar puncture may be performed optionally at the 18-month followup~          visit.~   "
176505|NCT01254851|"~     This study is a non-blinded randomized controlled trial. Consenting participants will be~     randomized to routine post-operative ambulation vs. goal-augmented post-operative care (they~     will be given a goal number of steps to take on each post-operative day) following in-patient~     gynecologic surgery.~   "
176506|NCT01254838|"~     The purpose of this study is to evaluate the safety and CTL reaction of novel peptide~     vaccination for advanced renal cell carcinoma~   "
176507|NCT01254825|"~     The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to~     placebo when it comes to analgetic efficacy after Knee-Arthroscopy.~   "
181546|NCT01188525|"~     The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug~     metabolism and their metabolites, after administration singly and simultaenously at~     predefined doses in 10 health volunteers.~   "
176482|NCT01255150|"~     Background:~      - Research has shown that the Epidermal Growth Factor Receptor (EGFR) gene is an important~     target for personalized lung cancer treatment. Individuals who have mutations in the EGFR~     gene have better responses when treated with certain personalized or targeted therapies~     compared with conventional chemotherapy. These mutations are more frequent in females with~     lung cancer who have never smoked, and different ethnic groups have different levels of~     frequency of the mutations. Researchers are interested in collecting more information on EGFR~     genetic mutations in Hispanics/Latinos with lung cancer, comparing the frequency of these~     mutations in males and females and smokers and nonsmokers. This study may lead to better,~     more personalized care approaches for all individuals with lung cancer.~      Objectives:~      - To study the frequency of Epidermal Growth Factor Receptor mutations in Hispanic/Latino~     individuals who have been diagnosed with non-small cell lung cancer.~      Eligibility:~      - Hispanic or Latino individuals who have been diagnosed with non-small cell lung cancer and~     who have lung tissue from a previous biopsy or surgery available for research purposes.~      Design:~        -  Participants will provide consent for researchers to examine lung tissue collected from~          a previous biopsy or surgery.~        -  Treatment will not be provided as part of this protocol.~   "
176483|NCT01255137|"~     Background:~      - Adrenocortical carcinoma is an aggressive cancer that starts in the adrenal gland at the~     top of the kidneys. It has a low survival rate if standard treatment options are not~     effective. Axitinib is an experimental drug that is being studied to determine if it can stop~     tumors from growing or make them smaller. Researchers are interested in investigating~     axitinib in individuals with aggressive or otherwise untreatable adrenocortical cancer.~      Objectives:~      - To evaluate the effectiveness of axitinib in individuals who have adrenocortical cancer~     that is inoperable and has not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with adrenocortical cancer~     that has not responded to standard treatments.~      Design:~        -  Participants will be screened with a full physical examination and medical history, as~          well as tumor imaging studies.~        -  Participants may have a tumor biopsy prior to starting axitinib.~        -  All participants will receive axitinib to take twice a day with food for 28 days (1~          cycle). Participants should not drink grapefruit juice or smoke cigarettes while~          participating in this study.~        -  After the first cycle, the dose may be increased and additional cycles will be given if~          the treatment has not had serious side effects.~        -  Participants will have regular examinations while taking axitinib, including blood~          samples and tumor imaging studies to determine if the tumor has stopped growing. Blood~          pressure levels will be carefully monitored during treatment to evaluate potential risk~          for high blood pressure.~        -  Participants may have a second tumor biopsy 20 to 30 days after treatment begins.~        -  Treatment will continue as directed by the study researchers.~   "
176484|NCT01255124|"~     Hand, Foot and Mouth Disease（HFMD）is an infectious disease in infants and young children~     caused by enterovirus. There was a great outbreak of HFMD in China, 2008, which brought not~     only panic to the people, but also huge economic loss. Since 2008, HFMD has become one of the~     category c infectious diseases in China. Studies showed that Human Enterovirus 71 (EV71) and~     coxsackievirus A 16 (CVA16) are the most common reasons for this disease. And the~     investigators are going to develop the vaccines for this disease. There is an urgent need to~     know the dynamic changes of the maternal anti-EV71 and ant-CVA16 level in infants and young~     children. In April 2007, the investigators started a clinical trial named 'The Safety and~     Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates'~     (ClinicalTrials.gov ID: NCT01183611). In that study the investigators already built a cohort~     of Health Neonates, followed them and obtained the blood serum on the day 0, 30, 210 and 360~     after born. So, based on the cohort and blood serum the investigators got, the investigators~     plan this study to retrospectively investigate their HFMD histories from birth and follow-up~     for another year to get the information about the incidence of HFMD. The investigators also~     plan to assay the maternal anti-EV71 and anti-CVA16 antibodies on the day0 and the dynamic~     changes of antibodies on 1st month, 7th month (day 210), 1st year (day 360) and on October,~     2010.~   "
176485|NCT01255111|"~     BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability~     and efficacy of this treatment during sleep in patients with chronic respiratory failure.~      AIM: To study the variability of patient-ventilator interactions during the first nights~     after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the~     non-linear dynamics theory.~      PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated~     to home NIV will be included. All patients will perform three polysomnographies (under~     spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All~     ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen~     saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep~     Laboratory of the Department and secondarily related to sleep architecture and quality of~     sleep.~      EXPECTED RESULTS: This study will identify objective parameters that are associated to a~     satisfactory adaptation to nocturnal NIV.~   "
176486|NCT01255098|"~     This plan is to develop blood culture or to measure diagnostics of Immuno Magnetic Reduction~     assay in the first stage.~   "
176487|NCT01255085|"~     It is hypothesized that yellow pea protein and fiber will reduce short-term food intake,~     subjective appetite and glycemic response.~   "
176488|NCT01255072|"~     This double-blind, controlled and randomized study intents to investigate the antidepressive~     response of rTMS on the elderly population.This is the first neuronavegated pulse intensity~     corrected study of rTMS in elderly depressed patients.~   "
176489|NCT01255059|"~     To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin~     Population.~   "
176490|NCT01255046|"~     The objective of this study is to evaluate the efficacy and safety of STA-1 vs placebo as an~     add-on treatment to donepezil in patients with mild to moderate Alzheimer's Disease (AD).~   "
176491|NCT01255033|"~     The purpose of this study is to compare the ability of two peripheral and non invasive~     devices to detect hypoxic events during one-lung ventilation and during the early~     postoperative period. One device measures regional cerebral oxygenation and the other~     muscular oxygenation. These two devices are compared to non invasive arterial saturation~     (SpO2), which is the gold standard.~   "
176493|NCT01255007|"~     1. Primovist-enhanced Magnetic resonance imaging (MRI) and Diffusion Weighted MRI (DW-MRI)~          is superior to Multidetector Computed axial Tomography (MDCT) in the detection of~          colorectal liver metastases. Fatty changes in the liver after chemotherapy treatment~          likely reduces the chances of seeing metastatic lesions on CT especially when the~          lesions are small (<10 mm). When compared with CT, Primovist-enhanced MRI and DW-MRI~          have the potential to provide higher contrast resolution enabling better detection of~          colorectal liver metastases following chemotherapy.~        2. Primovist-enhanced MRI and DW-MRI are superior to CT in assessing and predicting~          treatment response of patients with colorectal liver metastases to chemotherapy.~          Primovist-enhanced MRI by providing superior resolution may provide improved accuracy in~          metastatic lesion margin detection thereby providing higher accuracy in estimating tumor~          response based on size criteria. DW-MRI provides information indirectly about tumor~          composition and therefore is likely to be superior to MD-CT in assessing treatment~          response.~      Two groups of patients will be analyzed. The second group consists of patients with~     colorectal liver metastases who are to go for chemotherapy prior to surgery for metastases~     resection. This group will be CT and MRI scanned prior to chemotherapy and after~     chemotherapy. The first group of patients will consist of those patients who have already~     received chemotherapy and are likely to have surgery to resect liver metastases. This group~     will have only one set of scans done 4-6 weeks prior to their operation. The pathology of the~     resected metastases and CT and MRI images will be analyzed and compared.~   "
176494|NCT01254994|"~     To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients~     with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF~     were allocated into either a treatment group (ETV group, n=53) or a control group (n=55). The~     HBV DNA level, liver function and survival condition of the patients were observed for 48~     weeks after enrollment. The factors possibly related to entecavir treatment efficacy were~     also identified.~   "
176495|NCT01254981|"~     To perform a randomized comparison between the Cypher Select+ stent and the Nobori stent in~     the treatment of unselected patients with ischaemic heart disease.~   "
176496|NCT01254968|"~     The aim of the study is evaluation of cerebral blood flow (based on testing the rate of flow~     in middle cerebral arteries by transcranial Doppler ultrasound) during different forms of~     walking training - walk forwards and backwards, with closed and open eyes.~   "
176497|NCT01254955|"~     Organ transplant patients and staff members at the Transplant Institute have received~     pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by~     haemagglutination inhibition according to the clinical guidelines and policy, respectively.~     This study retrospectively assessed the immune response after vaccination.~   "
176498|NCT01254942|"~     This is a parallel Randomized Controlled Trial comparing two different delivery modes of post~     hip fracture management—a specialized Fracture Follow-up Clinic versus Usual Care alone. The~     Fracture Follow-up Clinic will focus on bone health and fall risk factors. The investigators~     will evaluate the effect of the clinic and exercise program on mobility and falls. The~     investigators primary hypothesis is that within the first year following a hip fracture,~     older adults who are assessed in the B4 Clinic and prescribed an exercise program will have~     significantly improved Short Physical Performance Battery (SPPB) scores compared with~     participants who receive usual care alone.~   "
176499|NCT01254929|"~     The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP~     bone scan to determine if one is better for diagnosing bone metastases.~   "
176500|NCT01254916|"~     Introduction: Chronic rhinosinusitis (CRS) is a significant health problem increasing in both~     incidence and prevalence. It calls into attention consensus about diagnosing, assessing~     symptoms and treatment of patients with CRS. Therefore a validated Danish measure of~     health-related quality of life in sinonasal disease is needed.~      Method: The Sinonasal Outcome measure 22 (SNOT-22) was translated into Danish and~     reproducibility was evaluated by test-retesting 40 patients with CRS. The statistical~     analyses used, were Pearson´s correlation coefficient, Cronbach´s alfa, Kappa and~     Bland-Altman´s Plot. Reproducibility was also tested looking at subscales within the SNOT-22.~      Result: The results show good internal correlation with Cronbach´s alfa at 0.83 in the~     initial test and 0.92 in the retest. Pearson was 0.70 (p<0.001) revealing good correlation~     between the initial scores and the retests scores. Kappa was calculated for each item with a~     mean value of 0.61 showing substantial agreement. Paired t-test revealed no significant~     difference in the subscales.~      Conclusion: The Danish version of SNOT-22 is recommended for Danish clinicians and researches~     as a patient-reported measure of outcome in sino-nasal disorders such as rhinosinusitis and~     nasal polyposis.~   "
176501|NCT01254903|"~     The goal of this clinical study is to learn the feasibility of using a single session of~     radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural~     spinal cord compression.~   "
176502|NCT01254890|"~     The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can~     control the disease in patients with AML or MDS. The safety of this drug combination will~     also be studied.~   "
176503|NCT01254877|"~     The proposed randomized clinical trial will investigate a novel pharmacotherapy for hazardous~     drinking, HIV-infected men and women, using the serotonin receptor (5-HT3) antagonist~     ondansetron. The investigators predict that participants who are treated with active doses of~     ondansetron will reduce their drinking more and show better HIV treatment participation and~     progress compared to participants who are treated with placebo. This study will provide~     important new safety and efficacy results on drinking and HIV outcomes following alcohol~     pharmacotherapy in HIV-infected persons.~   "
176504|NCT01254864|"~     You are being asked to take part in this study because you have prostate cancer that has~     spread to other parts of the body.~      This is an investigational study. Prednisone is FDA-approved and commercially available.~     Abiraterone acetate is FDA-approved and commercially available, but is still being~     researched. Sunitinib malate is FDA-approved for the treatment of gastrointestinal tumors and~     renal cell carcinoma, and dasatinib is FDA approved and commercially available for certain~     types of leukemia. The use of these drugs in prostate cancer and in combination with~     abiraterone acetate and prednisone is investigational.~      Up to 180 patients will be enrolled in this study. All will be enrolled at MD Anderson.~   "
176508|NCT01254812|"~     TAP-block (Transverse Abdominal Plane) block is a method of regional anesthesia used after~     abdominal surgery. The method is often applied ultra-sound guided.~      In our department, the so-called bilateral dual TAP-block (BD-TAP-block) has been developed.~     This includes injection of local anesthetics at four sites on the abdominal wall, aiming at~     the best possible spread of the nerve block.~      Clinical experience shows satisfying results on pain relieve using the nerve block, i.e the~     sensory nerves of the abdominal wall are successfully blocked. However, to our knowledge,~     clinical investigations regarding the effect on the muscles of the abdominal wall has never~     been executed.~      Patients with chronic lung diseases, who are prone to catch pneumonia post surgery, may have~     to be able to use accessory muscle groups to prevent pulmonary phlegm stagnation. Therefore~     it would be inappropriate if the motor nerves supplying these muscles were too, affected by~     the nerve block.~      Our clinical experience has so far not given us suspicion or indication that the motor nerves~     become blocked, although these nerves are situated in the same muscle layer as the sensory~     branches.~      Hence the investigators would like to examine on healthy, male subjects, whether application~     of a bilateral-dual TAP-block effects their ability to perform peak-flow and inspiratory and~     expiratory pressure. Our study hypothesis is:~      There is no clinically relevant difference in the spread of results of pulmonary tests (peak~     flow et.c.) before and after application of bilateral dual TAP-block.~   "
176509|NCT01254799|"~     This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the~     use of injectable contraception that contains one hormone progesterone only.~   "
176510|NCT01254786|"~     Video-assisted thoracoscopic surgery (VATS) is usually performed using well-collapsed lung is~     essential for optimum surgical visualization and resection. However, one lung ventilation~     (OLV) is associated with deleterious impaired oxygenation secondary to the increases in shunt~     fraction.1 There are different approaches for the recruitment of the non-dependent lung (NL)~     during OLV such as the selective application of continuous positive pressure ventilation~     (CPAP) or high frequency positive pressure ventilation (HFPPV) to the non-dependent lung.2-4~     These strategies may improve arterial oxygenation and reduce shunt fraction,2-4 However, the~     use of high CPAP levels impaired the surgical conditions during thoracotomy.2-3 On contrary,~     the application of HFPPV either to both lungs5or to the non-dependent lung permits adequate~     surgical conditions during thoracotomy.4 The investigators hypothesize that the application~     of volume-controlled HFPPV to the non-dependent lung during OLV for video-assisted~     thoracoscopic surgery may provide better surgical field and adequate oxygenation than the use~     of CPAP 2 cm H2O.~      The investigators will evaluate the effects of the selective application of conventional one~     lung ventilation, HFPPV, or CPAP 2 cm H2O to the non-dependent lung on surgical field~     conditions, and arterial oxygen and carbon dioxide tensions (PaO2 and PaCO2, respectively)~     during OLV in the patients scheduled for video-assisted thoracoscopic surgery.~   "
176511|NCT01254773|"~     This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1)~     safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid~     load as measured by positron emission tomography (PET) scans.~   "
176512|NCT01254760|"~     The purpose of this trial is to evaluate and compare the clinical performance of two~     multifocal contact lenses.~   "
176513|NCT01254747|"~     The purpose of this 4-week dispensing trial is to evaluate and compare an investigational~     soft contact lens worn on a daily disposable basis with three other soft contact lenses also~     worn on a daily disposable basis.~   "
176514|NCT01254734|"~     RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and~     neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical~     trial studies how transoral robotic surgery works in treating patients with benign or stage~     I-IV head and neck cancer.~   "
176515|NCT01254721|"~     The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy~     compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation~     of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using~     the last observation carried forward method.~   "
176516|NCT01254708|"~     Lung transplant recipients have the highest rate of Invasive Aspergillus (IA)infection among~     solid organ transplant recipients. The most important risk factor for the development of IA~     (which is associated with disease and death) is colonization of the organism in the~     respiratory tract.~      Azoles are used to prevent the development of IA. Puffers containing antifungal medication~     can be used to treat the lungs without the need to worry about the medication interactions &~     side-effects in the blood. An example of this is the aerosolized amphotericin B. Its use is~     limited by the patients' tolerating this medication that may cause cough, nausea &~     contraction of the air pathways.~      The lipid preparation is better tolerated and has longer dosing interval than inhaled~     amphotericin B. The investigators propose a pilot study to determine the long-term safety of~     inhaled AmBisome administration of drug and generate the preliminary data on the~     effectiveness of this drug to prevent aspergillus colonization.~   "
176517|NCT01254695|"~     Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population.~     The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has~     over the last decade given hope to patient failing conservative treatment. Some patient do~     not have optimal continence after SNS-therapy. This study aims to identify optimal~     stimulation parameters - that will improve the functional outcome of SNS-therapy thru a~     double blinded randomized cross-over study.~   "
176518|NCT01254682|"~     The primary objective of this study is to evaluate the efficacy and safety of Ostenil~     application (1% hyaluronan) after arthroscopy of the wrist.~   "
176533|NCT01254487|"~     The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix~     (Biolimus A9-Eluting) stent system in relation to safety and effectiveness.~   "
176549|NCT01254279|"~     The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial~     (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic~     Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or~     after docetaxel and to document the overall safety of cabazitaxel in these patients.~      Please note that in each country, patient recruitment will end when cabazitaxel becomes~     commercially available.~   "
176519|NCT01254669|"~     In the United States, Black women are more likely to die of cervical cancer than White women.~     In developing countries and globally, Haitian immigrant women are more likely to die of~     cervical cancer than any other women in the world. Studies have shown a disparity in parental~     acceptance of the HPV vaccine with parents of Black adolescent girls being less likely to~     accept and comply with HPV immunization schedules than Whites. The objective of this study is~     to increase HPV immunization rates in Haitian and African American adolescent girls. The~     investigator's hypothesis is that a validated behavior change mechanism, brief-negotiating~     interviewing (BNI), will effectively increase the proportion of mothers who give consent for~     their daughters' HPV vaccine, which will ultimately lead to higher vaccination rates, and~     increase knowledge of HPV infection and the vaccine in Haitian immigrant and African American~     mothers.~   "
176520|NCT01254656|"~     This is a study to assess long-term safety and efficacy of lersivirine in patients who have~     completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.~   "
176521|NCT01254643|"~     This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese~     girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable~     immune response to all human papillomavirus (HPV) strains contained in the vaccine. The~     success criterion for the primary analysis requires that point estimates for seroconversion~     rate be greater than 90% for all 9 HPV types.~   "
176522|NCT01254630|"~     This is a randomized, double-blind, placebo-controlled study to assess the safety and~     tolerability of V212 when administered to adults with solid tumor malignancy (STM) receiving~     chemotherapy and to assess the impact of V212 on the development of herpes zoster (HZ) in~     adults with STM receiving chemotherapy. The primary hypothesis is that vaccination with V212~     will reduce the incidence of HZ compared with placebo in adults with STM (lower bound of the~     97.5% {one-sided α=0.0125} confidence interval [CI] for the estimated vaccine efficacy in~     adults with STM be >25%).~      Participants with hematologic malignancy (HM) were also enrolled and were to be originally~     included in the primary and secondary objectives and analyses. After an interim analysis~     demonstrated clear evidence of futility of V212 in the HM population, enrollment of this~     population was stopped and all HM-related objectives and analyses were made exploratory and~     are not reported in this record.~   "
176523|NCT01254617|"~     This phase I trial studies the side effects and the best dose of lenalidomide when given~     together with cetuximab in treating patients with colorectal cancer or head and neck cancer~     that has spread to other places in the body and usually cannot be cured or controlled with~     treatment. Biological therapies, such as lenalidomide, use substances made from living~     organisms that may stimulate the immune system in different ways and stop tumor cells from~     growing. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways~     by targeting certain cells. Giving lenalidomide together with cetuximab may be a better~     treatment for colorectal cancer or head and neck cancer.~   "
176524|NCT01254604|"~     This study will test the hypothesis that preservative-free tafluprost (MK-2452) is~     non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular~     pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle~     glaucoma or ocular hypertension.~   "
176525|NCT01254591|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography~     (PET/CT) scanning before surgery, may help measure the extent of disease.~      PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with~     non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and~     neck cancer.~   "
176526|NCT01254578|"~     This phase I clinical trial is studying the side effects and the best dose of lenalidomide~     after donor bone marrow transplant in treating patients with high-risk hematologic cancer.~     Biological therapies, such as lenalidomide, may stimulate the immune system in different ways~     and stop cancer cells from growing.~   "
176527|NCT01254565|"~     The purpose of this study is to characterize the safety and tolerability and efficacy of~     multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of~     secondary hyperparathyroidism (HPT).~   "
176528|NCT01254552|"~     This study is aimed to answer the clinical question of the prevalence of myocardial scar in~     asymptomatic patients with type 2 Diabetes Mellitus with a special focus on the diagnostic~     efficacy of Xenetix® 350-enhanced 64-rows MDCT for the visualisation of the coronary arterial~     tree and secondarily for the assessment of myocardial viability when using Dotarem®~     enhanced-cardioMR as the gold standard examination.~   "
176529|NCT01254539|"~     The purpose of this clinical trial is to assess the feasibility and the security of the~     intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment~     of Amyotrophic Lateral Sclerosis patients.~   "
176530|NCT01254526|"~     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy~     regimens utilized in patients with locally recurrent or metastatic breast cancer.~   "
176531|NCT01254513|"~     The objective of this study is to evaluate the feasibility of two different chemotherapy~     protocols with adjusted doses for patients aged 75 and over who often have medical problems~     other than prostate cancer. Patient will receive Docetaxel either every 3 weeks or weekly. In~     both cases, chemotherapy is combined with prednisone. The protocol will be considered~     feasible when patient will receive 6 cycles of chemotherapy (1 cycle = 3 weeks).~      Additionally to this primary objective, efficacy will also be evaluated for both protocols as~     well as tolerance to treatment, quality of life and evolution of geriatric data.~   "
176532|NCT01254500|"~     Event-related potentials (ERPs）has the advantage of excellent temporal resolution on~     measuring real-time neural activities that reflect to higher level cognitive processes. A~     research project related to lesion studies in which patients with cognitive function~     impairment and communication disorder will be recruited as participants to examine their~     impairment as well as residual abilities by using ERPs. Hopefully, expected findings will~     provide further analysis based on the patterns of neural activities revealed by both patients~     and normal controls should be able to provide important evidence toward building the~     cross-linguistic theory. The findings also have applications on diagnostic and evaluation for~     patients with brain lesions for clinical application with communication disorder.~   "
176534|NCT01254474|"~     Monophasic action potential (MAP) recording plays an important role in a more direct view of~     human myocardial electrophysiology under both physiological and pathological conditions. The~     MAP method represents a very useful tool for an electrophysiological research in cardiology.~     Its crucial importance lies in the fact that it enables the study of the action potential~     (AP) of myocardial cell in vivo and, therefore, the study of the dynamic relation of this~     potential with all the organism variables what can be particularly helpful in the case of~     arrhythmias.~      Hundred and fifty patients will be included to explore mapping capabilities in cardiac~     chambers in patients suffering from regular or fibrillating tachycardia's with the following~     inclusion plan: i) Atrial fibrillation at a total of 50 patients ii) Ventricular fibrillation~     or patients at high risk of sudden cardiac death at a total of 50 patients iii) Junctional~     tachycardia at a total of 50 patients. We will focus on cardiac activation (depolarization~     and repolarization) in this population.~   "
176535|NCT01254461|"~     The primary purpose of this study is to determine whether the treatment with AZD1981 will~     affect the pharmacokinetics of pravastatin.~   "
176536|NCT01254448|"~     This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619~     in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects~     with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and~     tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to~     receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.~   "
176537|NCT01254435|"~     Colonoscopy is the gold standard investigation in the screening of colorectal neoplasms. The~     investigators hypothesise that visualisation of the colonic mucosa on extubation may be~     improved by changing patient position as follows: left lateral position for the right colon,~     supine for the transverse colon and right lateral position for the left colon(fixed~     positioning). The investigators aim to validate our hypothesis by performing a randomised~     control study, comparing mucosal visualisation in patients placed in the 'routine' positions~     at the discretion of the endoscopist with visualisation in those placed in the above~     described positions. The hypothesis is that fixed positioning confers an advantage.~   "
176538|NCT01254422|"~     The purpose of this study is to evaluate the safety and immunogenicity of Phase III lots of~     the CYD dengue vaccine in a pediatric population in Malaysia.~      Primary Objectives:~        -  To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD~          dengue vaccine in all subjects after each dose.~        -  To describe the antibody response to each dengue virus serotype post-Dose 2 and~          post-Dose 3~   "
176539|NCT01254409|"~     The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and~     the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.~   "
176540|NCT01254396|"~     This study will evaluate if an orally disintegrating tablet of sildenafil will have similar~     pharmacokinetic properties when given with food and without food.~   "
176541|NCT01254383|"~     This study will evaluate if an orally disintegrating tablet of sildenafil will have similar~     pharmacokinetic properties as the conventional tablet of sildenafil.~   "
176542|NCT01254370|"~     The purpose of this study is to compare:~        -  the effect of Catioprost® and Travatan Z® on the ocular surface disease (OSD) in~          subjects with glaucoma or ocular hypertension and ocular surface disease.~        -  the intraocular pressure (IOP) lowering effect and safety of Catioprost® and Travatan Z®~          in subjects with glaucoma or ocular hypertension and ocular surface disease.~   "
176543|NCT01254357|"~     As part of Clinical Trials.Gov ID:NCT00253292 a psychometrically sound outcomes instrument~     was developed to study the outcomes of burn survivors in the 19-30 year old age group. This~     workgroup has come together to re-examine the data collected during the previous study and~     determine next steps in understanding the recovery for this population.~   "
176544|NCT01254344|"~     The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared~     with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection~     following elective colorectal surgery in Chinese adults. This study is designed to~     demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this~     participant population.~   "
176545|NCT01254331|"~     This open-label, multi-center study in a local environment will evaluate the safety and the~     effect on disease activity with regard to reduction in signs and symptoms over 6 months of~     treatment in patients with moderate to severe active rheumatoid arthritis who experienced an~     inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an~     intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in~     combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.~   "
176546|NCT01254318|"~     This will be a retrospective study that includes retrospective chart reviews at major~     institutions across Canada. The intent of the study is to generate both regional and national~     incidence data for non-Candida invasive fungal infections (IFI) in high risk participants.~     The study will include participants receiving stem cell transplant and high dose chemotherapy~     treatment for leukemia.~   "
176547|NCT01254305|"~     The purpose of the study is to evaluate the efficacy, safety and tolerability of~     Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder~     (MDD).~   "
176548|NCT01254292|"~     The primary objective of this study is to evaluate user satisfaction and tolerability in~     young women (18-29 years of age) using the LCS12 compared with young women using a COC~     (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use~     of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional,~     extension phase. Safety data only will be collected during the extension phase of the study.~      Secondary objectives are to observe the tolerability, discontinuation rates, adverse event~     profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]),~     and bleeding profiles with the two birth-control methods. Additionally, data on missed~     tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system~     (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician~     satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal~     threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of~     subjects) will be collected. Finally, in the COC group, information will be collected on the~     psychosocial impact of missed or delayed pill intake.~   "
176550|NCT01254266|"~     The major problem in the treatment of morbidly obese children is the long term maintenance of~     the reduced weight. Maintenance-focused interventions have not been studied enough in~     adolescents with morbid obesity, neither in regard to conservative methods of weight~     reduction, nor in regard to bariatric surgeries.~      This study will investigate the effectiveness of an integrative, multi-disciplinary inpatient~     program for promoting long-term weight maintenance in children with morbid obesity. The~     program will be studied in two perspectives: as a conservative treatment, as well as an~     'envelope' for bariatric surgeries including a pre-operational preparation phase and a~     post-operational follow-up.~      The investigators hypothesize that program participants will maintain weight significantly~     better than the proportion known in the literature.~   "
176551|NCT01254253|"~     The purpose of this study is to compare the diagnostic accuracy of hybrid imaging combining~     CTCA with low-dose stress-only SPECT vs. coronary angiography for detecting haemodynamic~     relevant coronary lesions; and second to determine the effects of PCI on cardiac perfusion,~     cardiac function and quality of life in patients with CTO lesion in left anterior descending~     (LAD) coronary artery.~   "
176552|NCT01254240|"~     This is a double-blind prospective randomized monocenter study comparing the efficacy of two~     phototherapy ultraviolet spectra on pruritus (itching) of inflammatory skin diseases. 40~     patients per treatment, in total 80 study participants.~   "
176553|NCT01254227|"~     This study will evaluate the efficacy and safety of deferasirox in combination with~     deferoxamine followed be deferasirox monotherapy in patients with severe iron overload due to~     chronic blood transfusions.~   "
176554|NCT01254214|"~     The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress~     Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered~     mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and~     improve quality of life for people waiting for a kidney transplant. Participants will be~     randomly assigned to tMBSR or to a support group emphasizing communication skills and~     selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly~     teleconference calls, and conclude with an in-person meeting. Participants will complete~     questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will complete~     additional questionnaires. Participants will complete sleep diaries and wear Actiwatches~     (similar to a wristwatch) for one week before programs start, and when programs end, to~     measure sleep. Participants will provide saliva samples, over 3 days before programs start,~     and again when programs end, to measure salivary cortisol, an indicator of stress. tMBSR~     participants will record daily home meditation practice.~   "
176555|NCT01254201|"~     Dry eyes are a very common complaint. In some patients, we can identify the reason for the~     dryness; however, in others the dryness has no clear cause. Dryness can lead to eye~     irritation, redness, and sometimes changes in vision. Fibromyalgia is a condition of chronic~     pain that is poorly understood but seems to have a component of altered sensory processing.~     People with fibromyalgia tend to complain of dry and irritated eyes at a higher rate than the~     general population. We plan to evaluate patients with dry eye symptoms for abnormalities in~     sensory processing and in their autonomic nervous system. We hope to learn about possible~     relationships between dry eye symptoms and fibromyalgia in order to better understand and~     treat these conditions.~   "
176556|NCT01254188|"~     This study will further investigate the safety and efficacy of nilotinib in newly diagnosed~     chronic myeloid leukemia patients in the chronic phase~   "
176557|NCT01254175|"~     Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory~     diseases in infants and children. This study will evaluate the safety and immune response of~     an HPIV3 vaccine in infants and young children.~   "
176558|NCT01254162|"~     To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum~     production on the forehead of healthy male volunteers.~   "
176559|NCT01254149|"~     The primary purpose of this study is to determine whether topical ophthalmic anesthetics~     lower the intraocular pressure in the eye.~   "
176560|NCT01254136|"~     This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839~     in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast~     cancer.~   "
176561|NCT01254123|"~     Myocardial infarction (MI) causes loss of myocytes and may lead to loss of ventricular~     function, morbidity and mortality. The most effective therapy is early reperfusion of the~     ischemic myocardium by percutaneous coronary intervention (PCI). Reperfusion limits~     myocardial ischaemic necrosis, but also induces inflammation, oxidative stress and calcium~     overload: a process referred to as reperfusion injury leading to necrosis and apotosis.~     Glucagon Like Peptide-1 (GLP-1) is an incretin hormone that has shown to activate~     anti-apoptotic enzymes, reducing reperfusion injury. GLP-1 agonists have been demonstrated to~     be cardioprotective in several animal studies and in a single small non-randomized clinical~     study. In this pilot study we will assess the safety and efficacy of GLP-1 receptor agonist~     Exenatide infusion compared to placebo in patients with an acute myocardial infarction~     undergoing primary PCI.~      A total of 40 patients will be included in this single centre prospective randomised placebo~     controlled two-arm pilot study. Patients who are to undergo a primary PCI for a first acute~     ST elevation myocardial infarction are randomly assigned to placebo or Exenatide 5ug bolus in~     30 minutes, followed by a continuous Exenatide infusion of 20ug/ 24 hours for 72 hours. Blood~     samples are obtained for assessment of enzymatic infarct size and Exenatide levels. Side~     effects of Exenatide are stringently monitored. Cardiac function will be measured using~     Cardiac Magnetic Resonance Imaging (CMRI) and 3D echocardiography at 1 week and 4 months post~     MI. Infarct size will be assessed by means of the final infarct size at 4 months post MI as a~     percentage of the area at risk at 1 week post MI. Furthermore we will compare the RNA profile~     of both groups.~   "
176562|NCT01254110|"~     Gut protein metabolism that could be influenced by protein supply is involved in the~     regulation of several physiological functions such as gut barrier function and represents a~     major contribution in the whole-body protein turnover. Intracellular pathways implicated in~     the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of~     the present project is to evaluate and to understand the effects of amino acids (glutamine,~     leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.~   "
176563|NCT01254097|"~     Antibiotics are lifesaving medicines and generally safe, yet unwanted side effects are~     common. While destroying illness-causing 'bad' bacteria, antibiotics can upset the protective~     'good' bacteria in the body. This research will test if taking a probiotic with prescribed~     antibiotics will decrease the chance of having bothersome antibiotic-associated side effects.~   "
176564|NCT01254084|"~     The aim of the present study was to investigate the effects of Gynostemma Pentaphyllum tea on~     insulin sensitivity in drug-naïve type 2 diabetic patients.~   "
176565|NCT01254071|"~     This study will be an open-label, randomized, single dose, two-period crossover study to~     determine the bioavailability of a fixed dose combination capsule formulation of dutasteride~     and tamsulosin hydrochloride (0.5mg/0.2mg) relative to co-administration of dutasteride 0.5mg~     capsules and tamsulosin hydrochloride 0.2mg tablets in healthy male subjects of North East~     Asian and non-Asian ancestry. Subjects will receive single oral doses of a combination~     capsule formulation of dutasteride 0.5 mg/ tamsulosin 0.2 mg in a fed or fasted state or~     concomitant dosing of dutasteride 0.5 mg and the Japan-sourced Harnal-D 0.2 mg in a fed or~     fasted state. Each dose of study medication will be separated by a 28-day washout period.~     Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing.~     Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data,~     and review of adverse events. The study will enrol 88 healthy male subjects to ensure that 80~     complete the study. At least twenty percent of the study population will be of Japanese~     ancestry, approximately 20% will be of Chinese ancestry and approximately 20% of Korean~     ancestry while the remainder of the population will be of non-Asian ancestry.~   "
176566|NCT01254058|"~     The purpose of this study is to determine whether rapid eye movements called saccades are~     impaired in glaucoma, a neurodegenerative disease of visual pathways.~   "
176567|NCT01254045|"~     The purpose of this study is to determine whether the medication oxytocin is an effective and~     tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially~     appropriate behaviors and reducing social anxiety.~   "
176568|NCT01254032|"~     Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial~     impact on a patient's life. However, the impact of COPD is currently under-recognised and, as~     a result, COPD is under-treated. An exacerbation of COPD is a major element that causes poor~     quality of life and loss of productivity. Therefore, minimizing the frequency of~     exacerbations is a short term treatment goal in COPD management and could improve Quality of~     Life (QoL) significantly in all severity groups of COPD.~      Although the use of spirometry for the determination of disease severity in COPD is supported~     by guidelines, a lung function test alone does not provide a measurement of the overall~     impact of COPD on health status and is not generally available especially in primary care~     centre. Therefore, a standardised and effective dialogue between patients and physicians in a~     consultation could address the impact of COPD on a patient's QoL in this situation.~      The COPD Assessment Test (CAT), recently launched in 2009, is a short and simple,~     self-administered questionnaire designed to assess the condition of patients and overall~     impact of COPD, and to improve patient-physician communication. It has been proven that the~     CAT has good repeatability and discriminative properties which suggest that it is sensitive~     to treatment effects at a group level. The CAT score with its better ability to assess the~     impact of COPD on patients, suggests potential to predict a significant change in COPD status~     such as acute exacerbations of COPD.~      Since the CAT is designed to assess the impact of COPD on the patient by measuring overall~     impairment, it has better correlations with other instruments, such as the Clinical COPD~     Questionnaire (CCQ), MRC (Medical Research Council) dyspnoea scale, St George's Respiratory~     Questionnaire (SGRQ),and the 6-minute walk test. However, it does not correlate well with~     FEV1 (Forced Expiratory Volume in One Second).~      While the CAT shares some similarities with other questionnaires, there are several important~     differences. For example, the SGRQ is substantially longer than the CAT, is complex to~     administer and requires the use of a computer for scoring. The CAT is designed to provide a~     holistic measure of the impact of COPD on the patient, whereas the MRC dyspnoea scale only~     measures dyspnoea, and the CCQ only assesses clinical disease control. Thus, the CAT is the~     only validated, short and simple assessment test which can provide a holistic measure of the~     impact of COPD on patients, ensuring both the physicians and the patients gain the~     understanding needed to manage COPD optimally.~      QoL is defined as an individual's perception of their position in their life in the context~     of the culture and value systems. Therefore, the extent of understanding of the questionnaire~     might be influenced by language and ethnicities. Since the validation findings so far have~     been based on data from the US and Europe, PACE may provide better quality of data across~     ethnic groups given that mainly Asian subjects will participate in this study.~      PACE is designed to evaluate whether the CAT has a high predictive value in detecting~     subsequent exacerbations of COPD. If so, this result might enable both patients and~     physicians to better target and optimise management. The primary objective is to evaluate the~     predictability of the CAT to have subsequent exacerbations in COPD patients. Secondary~     objectives are to evaluate the predictability of the CAT to have moderate to severe~     exacerbations or time to the first exacerbation, to identify risk predictors for COPD~     exacerbations, and to evaluate correlations between CAT scores and FEV1 values, or MRC~     dyspnea scores. An experimental objective is to evaluate the correlation between the CAT~     score between 2 consecutive follow-ups (e.g. Week 8 & baseline, Week 16 & Week 8) and a COPD~     exacerbation over the following treatment period adjusting for demographics, MRC scores, lung~     function parameters, medical history, and therapy history.~      PACE is a multicentre, prospective, observational study designed to evaluate the~     predictability of the CAT score to have COPD exacerbations over 24 weeks. During the study,~     subjects continue taking their regular prescribed treatment. Investigators are free to make~     medication adjustments where required. Eligible subjects will have a clinic visit every 8~     weeks, during which they will complete the CAT questionnaire, the Exacerbation Check List~     (ECL), MRC dyspnea scale, and spirometry. A regular phone call is placed every 8 weeks in~     between clinic visits to collect data for the ECL.There is no follow-up period.~      550 male and female outpatient subjects will be recruited for PACE to obtain approximately~     300 exacerbation events. This study will capture the winter periods in Australia, China,~     Korea and Taiwan, when incidence of exacerbations is at its peak.~      Statistical analysis will be performed on subjects' data to derive the PACE end-points.~   "
176569|NCT01254019|"~     The purpose of this study is to determine whether GSK2402968 is effective in the treatment of~     ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be~     corrected by exon 51 skipping.~   "
176570|NCT01254006|"~     In this study the investigators are going to study the retinal nerve fibers layers (RNFL)~     modification of two groups of patients, one taking no drugs, the other taking forskolin,~     rutin and vitamins B1 and B2.~   "
176571|NCT01253993|"~     There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in~     middle childhood are associated with an increased risk for substance abuse in adolescence.~     However, the exact underlying mechanism of this increased risk is unknown. It is likely that~     a biopsychological vulnerability in some aggressive children and children with DBD makes them~     liable to substance use and abuse. The investigators hypothesize that deficient decision~     making is such a biopsychological factor. In this study the investigators aim to test the~     latter hypothesis by investigating the decision making ability in a group of adolescents with~     DBD with and without substance use disorders. Decision-making is assessed with the IOWA~     Gambling Task (GT). This task mimics real-life situations in the way it factors uncertainty,~     reward and punishment. The GT is specifically designed to assess impaired decision-making in~     individuals who are unable to learn from their mistakes and make decisions that repeatedly~     lead to negative consequences. This characteristic may be common to individuals with~     externalizing disorders such as DBD, psychopathy, and substance use disorders.~   "
176572|NCT01253980|"~     Paraffin (kerosene) ingestion in the developing world accounts for a large number of visits~     to healthcare facilities, especially amongst children. There is no evidence in animals and no~     good evidence in humans that the use of early antibiotics improves the clinical outcome of~     paraffin-induced pneumonitis. This randomised placebo-controlled trial will investigate~     whether the use of early antibiotics affects the clinical course of children with pneumonitis~     following paraffin ingestion.~   "
176573|NCT01253967|"~     The purpose of this hospital based study is to estimate the proportion of rotavirus~     gastroenteritis in children < 5 years of age in Romania.~   "
176574|NCT01253954|"~     The incidence of invasive candida infection (ICI) in critically ill patients is increasing~     day by day. The crude mortality of IFI in ICU could be as high as 25%-75% depending on their~     age, underlying conditions, and so on. Candida albicans was by far the predominant species in~     most countries, causing up to two thirds of all cases of invasive candidiasis. However, a~     shift toward non-albicans Candida species has been observed. Although the studies of ICI~     cause universal attention recently, there is still no large-scale, multi-center~     epidemiological research in China focusing on ICI in critically ill patients, therefore we~     conducted a large-scale multi-center observational study of IFI in critically ill patients~     named China Scan (CHINA Survey of Candidiasis in ICU) to assess the current incidence,~     mortality, pathogen spectrum, management, and risk factors for ICI in China ICUs.~   "
176585|NCT01253811|"~     This trial will be conducted in Asia, Europe and the United States of America (USA).~      The aim of this clinical trial is to investigate long-term safety of rFXIII when administered~     for prevention of bleeding episodes in children aged between 1 and 6 years with congenital~     FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4,~     NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on~     when recombinant factor XIII will be commercially available in subject's respective country~     for use in children of 1-6 years of age.~   "
176586|NCT01253798|"~     The purpose of this study is to determine which group exercise one should choose when hip~     osteoarthritis patients have undergone hip replacement surgery. To determine this, we want to~     answer the following research question:~      Are there differences in function and muscle strength in osteoarthritis patients who conduct~     group training either on land or in water in the rehabilitation phase following hip~     replacement surgery?~   "
176587|NCT01253785|"~     Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.~   "
176588|NCT01253772|"~     Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples~     during cardiac surgery.~   "
176589|NCT01253759|"~     This is a report of 10 years results of combined Transpupillary thermotherapy (TTT) treatment~     with Indocyanine green (ICG) in controlling small and medium-sized choroidal melanomas.~   "
176575|NCT01253941|"~     Rehabilitation and physical therapy strategies targeting extra pulmonary manifestations of~     Chronic Obstructive Pulmonary Disease (COPD)are far from being well defined. Studies,~     performed in healthy subjects using threshold breathing device [a simple method to increase~     inspiratory muscle load] have shown that ventilatory muscle overactivation during loaded~     breathing may prime reactive oxygen species (ROS) production, thus initiating an inflammatory~     response that results in elevation of pro-inflammatory cytokines, particularly IL_6. Increase~     of cytokine IL_6 in turn, elicits a cascade of systemic responses, involving hormone like~     glucoregulatory mechanisms, lipolysis and fat oxidation, as well as control of breathing.~      Thermal mud bath therapy has been acknowledged for its antioxidant and anti-inflammatory~     effects in several chronic diseases. However, it is not considered among treatment options of~     chronic pulmonary disease. Previous experimental studies indicate that trace elements of~     thermal treatments, particularly iodide and bromide, may positively intervene in the setup~     and maintenance of active state in skeletal muscle. These findings suggest that in COPD~     patients these elements may improve the loading and endurance of respiratory muscles and~     therefore blunt ventilatory muscle overactivation and the ensuing inflammatory cytokine~     response.~      In this study the investigators want to test two major hypotheses. First, that mud bath~     therapy reduces systemic inflammatory processes in COPD patients, increases respiratory~     muscle endurance and normalizes the ventilatory response. Second, that the increase in~     systemic inflammation after IRB exercise is blunted by mud bath therapy.~   "
176576|NCT01253928|"~     Non diabetic patients on renal replacement therapy are prone to changes in body composition~     with an increase in visceral fat and muscle wasting all favoured by the insulin resistant~     state. Malnutrition is associated with a worst prognosis in these patients. Glitazones are~     the most powerful insulin sensitisers available in clinical practice which also have~     anti-inflammatory properties. Their use has been associated with significant and favourable~     changes in body fat distribution in type 2 diabetic subjects. Experimental studies suggest~     that glitazones may attenuate muscle wasting in renal failure.~      The goal of this study was to examine in non diabetic ESRD patients the effects of~     pioglitazone on inulin sensitivity and protein metabolism as determined by the~     hyperinsulinemic euglycemic clamp and on changes in body composition as determined by~     anthropometric measurements, dual energy X-ray absorptiometry (DEXA) and CT-scan determined~     changes in abdominal visceral and sub-cutaneous fat.~   "
176577|NCT01253915|"~     This multi-center, double-blind, placebo-controlled, parallel group trial carbon dioxide in~     the treatment of moderate to severe migraine. At approximately 8 US sites, approximately 450~     patients who meet the eligibility criteria will be randomized to active or placebo in a 1:1~     ratio to ensure that 400 patients will treat at least one moderate to severe migraine with~     the study drug.~      Patients will be randomized to one of two treatment groups and be provided with either an~     active or placebo dispenser.~      All patients will administer study drug for 10 seconds to each nostril when experiencing a~     qualifying headache. Patients will assess their pain and other migraine-related symptoms in a~     patient diary. If a patient still has pain and/or any other symptoms after the initial dose~     then the patient may opt to take 3 more doses to treat the headache.~      Each patient's participation in the study may last up to 56 days or once the patient treats 4~     headaches with the study drug, whichever occurs first.~      There will be a total of 2 scheduled clinic visits:~        -  Visit 1 Screening/Randomization~        -  Visit 2 End of Study (within 7 days after the patients treats his/her fourth headache or~          after the end of the 56-day treatment period, whichever occurs first)~   "
176578|NCT01253902|"~     This study evaluated the ocular surface tolerability of the prostaglandin analogues~     bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004%~     (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously~     treated with Xalatan® who have open-angle glaucoma or ocular hypertension.~   "
176579|NCT01253889|"~     The purpose of this study is to compare the effect of a 25% glucose solution given via a~     soother with or without facilitated tucking with a similarly administered water placebo~     (control condition) on infant stress responses during and immediately after a neonatologist~     performed ECHO (np-ECHO).~   "
176580|NCT01253876|"~     Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats,~     inositols might have beneficial effects on weight control and blood pressure management. Most~     studies in this regard have been conducted on postmenopausal or premenopausal women and there~     are few studies on female youths. Therefore, we are going to determine the effects of soy~     consumption on the weight, waist circumference and blood pressure in overweight and obese~     female youths. This was a cross-over randomized clinical trial which was conducted in 2010 in~     Isfahan on overweight or obese young female youths. After three weeks run-in, females were~     randomly assigned to consume a diet containing caw's milk or a diet in which only one glass~     of soy milk was substituted; each one for six weeks. Random sequencing generated in SPSS was~     used for allocating females in different group randomly. Patients were not blinded because~     they had to use soy milk in one period of trial and use caw's milk in another period.~   "
176581|NCT01253863|"~     The purpose of this study is to determine the accuracy of preoperative clinical examination~     in penetrating injuries~   "
176582|NCT01253850|"~     HIV is increasing among adolescents and young adults in the US. Antiretroviral medications,~     when taken correctly (≥90% of prescribed doses taken), can vastly improve life expectancy.~     However, adherence among HIV-infected young people is suboptimal, and few interventions are~     available to help adolescents adhere to treatment.~      The first phase of the study is an intervention development phase, which includes conducting~     interviews with 40 HIV-infected youth for input on the adaptation of the approach. The~     information obtained from the qualitative interviews is used to adapt the Life-Steps~     intervention (designed by our group for HIV-infected adults) to be responsive to the needs of~     HIV-infected adolescents, with acceptability of topics and content, and feasibility of~     intervention delivery to be tested in an open pilot trial.~   "
176583|NCT01253837|"~     The recombinant human fusion protein L19TNFα was created with the intention to overcome the~     systemic toxicity of TNFα by directly targeting it to tumor tissues. Tumor-targeted L19TNFα~     would result in high and sustained intralesional bioactive TNFα concentrations.~   "
176584|NCT01253824|"~     The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and~     LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration~     cycle.~   "
176590|NCT01253746|"~     The Genetics of Neural Tube Defects Study at the University of Miami: The University of Miami~     John P. Hussman Institute for Human Genomics is looking for families to participate in~     research to identify the genetic and environmental factors that contribute to Neural Tube~     Defects (NTD). Our research goal is to better understand the genetic and environmental causes~     of both open NTD, like spina bifida and anencephaly, and closed NTD, like lipomeningocele and~     tethered cord. This will eventually lead to more accurate genetic counseling and risk~     assessment, improved treatments, and better prevention methods. Any individual with a~     diagnosis of NTD and his/her selected family members can participate, if willing.~     Participation is free. Travel is not required. Participation involves reading and signing a~     consent form, providing a blood sample, a family and medical history interview, and granting~     the research staff permission to review the medical records of the individual(s) with NTD. We~     maintain the highest standards of confidentiality for all families. If interested, please~     contact Maria Ciliberti, the study coordinator, at 1-877-686-6444 (toll free) or directly at~     305-243-4360, or by email Mciliberti@med.miami.edu . Please visit our web site at~     www.hihg.org for more information.~   "
176591|NCT01253733|"~     UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self~     management web and text message based program on health-related self-efficacy and frequency~     of adolescent-conducted healthcare interactions. We hypothesize that users of the program~     will demonstrate greater gains between baseline and 8 month measures of health related~     self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care~     comparison group.~   "
176592|NCT01253720|"~     UC San Diego researchers conducted a study to develop and evaluate an internet and text~     message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors.~     We hypothesized that those study participants randomized to the intervention will demonstrate~     greater reduction in BMI-z score as compared to the control group.~   "
176593|NCT01253707|"~     First in human, open-label, sequential dose escalation and expansion study of AMG 337 in~     subjects with advanced solid tumors.~   "
176594|NCT01253694|"~     Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to~     Bevacizumab.~   "
176595|NCT01253681|"~     To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well~     tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial~     ovarian, primary peritoneal and fallopian tube cancers. The hypothesis is that AMG 386 in~     combination with carboplatin and paclitaxel is safe and well tolerated.~   "
176596|NCT01253668|"~     This is a phase II study of an investigational agent, brivanib, in patients with refractory~     metastatic renal cell carcinoma. This study will evaluate the safety and effectiveness of~     brivanib in renal cell carcinoma, and explore the activity of this drug in this population to~     determine whether imaging and molecular features of the tumors can be used to predict~     response. Approximately 30 people with advanced kidney cancer will be enrolled on this study~     at the University of Pennsylvania.~   "
176597|NCT01253655|"~     The purpose of this study is to evaluate the relationship between plasma drug levels and~     receptor binding in brain using PET; and to evaluate safety and tolerability after a single~     administration of PF-05212365 in healthy volunteers~   "
176598|NCT01253642|"~     This phase II trial studies how well giving phenelzine sulfate together with docetaxel works~     in treating patients with prostate cancer that is growing, spreading, or getting worse after~     first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work~     better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together~     with docetaxel may kill more tumor cells.~   "
176599|NCT01253629|"~     This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective~     in treating the behavioral symptoms of Fragile X Syndrome.~   "
176600|NCT01253616|"~     This is a proof-of-concept study designed to provide feasibility information on the clinical~     use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus.~     The study is expected to give preliminary efficacy and safety information.~   "
176601|NCT01253603|"~     This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free~     patients with mild to moderate persistent asthma.~   "
176602|NCT01253590|"~     The purpose of this study is to assess whether it is possible and acceptable to monitor~     patients at a distance who experience a condition called atrial fibrillation after their~     cancer surgery. Some patients have no other clinical reason for staying in the hospital after~     cancer surgery except in order to control their heart rhythm. Being able to send these~     patients home earlier and monitor them at a distance from their home can be good for their~     quick recovery. Studies have shown greater quality of life and patient satisfaction when~     patients are monitored at a distance for conditions like atrial fibrillation, however cancer~     patients have not been studied.~   "
176603|NCT01253577|"~     The purpose of this study is to assess the safety and efficacy of the Propel mometasone~     furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients~     with Chronic Sinusitis (CS).~   "
176604|NCT01253564|"~     This open-label study will assess the safety and efficacy of RO5185426 in previously treated~     metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose~     of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.~   "
176605|NCT01253551|"~     The purpose of this study is to confirm the absence of a clinically relevant interaction~     between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the~     treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV~     infection.~   "
176606|NCT01253525|"~     Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in~     combination with paclitaxel.~   "
176607|NCT01253512|"~     This will be a randomized, double-blind, placebo-controlled, multi-center, multi-national,~     escalating dose, pilot study comparing two doses of THR-18 to placebo when administered to~     patients suffering acute ischemic stroke and treated with Tissue Plasminogen Activator (tPA).~      The study hypothesis is that THR-18 will be safe and well tolerated in subjects suffering~     acute ischemic stroke and treated with Thrombolysis.~   "
176610|NCT01253473|"~     The main objective of the study is to see if using anti-inflammatory to patients with airway~     disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than~     using these treatments in patients with loss of lung tissue. Symbicort plus~     ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with~     airway predominant COPD.~   "
176611|NCT01253460|"~     The goal of this clinical research study is to learn if sapacitabine given in combination~     with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The~     safety of this drug combination will also be studied.~   "
176612|NCT01253447|"~     This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients~     with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
176613|NCT01253434|"~     The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in~     healthy Japanese male volunteers.~   "
176614|NCT01253421|"~     The purpose of this study is to evaluate the effects of a single low dose of the D2/D3~     antagonist amisulpride on reward processing. More generally, this study will test the role of~     dopamine (a naturally occurring brain chemical) in depression.~      Hypotheses:~      Administration of a single low dose of the D2/D3 antagonist amisulpride will (1) improve~     performance in a behavioral task assessing learning from feedback and (2) boost activation in~     reward-related brain regions.~   "
176615|NCT01253408|"~     Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no~     effective and safe medications approved for the treatment of abdominal pain associated with~     bowel symptoms in IBS. This study will investigate the effects of an approved medication,~     Dronabinol, on the movement of food through the stomach and colon in subjects with a history~     of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).~      Dronabinol is a synthetic medication (a medication made in a laboratory) related to the~     active ingredient of cannabinoid or marijuana. Dronabinol is approved by the Food and Drug~     Administration (FDA) for preventing nausea and vomiting in patients with cancers undergoing~     chemotherapy. It is also used in AIDS patients with excessive weight loss for improvement in~     appetite and weight gain.~      The hypothesis in this study is that dronabinol will slow down the movement of food through~     the colon, and that this effect is regulated by the genes controlling the body messengers~     (receptors) that respond to medicinal marijuana or synthetic medicines that work on the same~     messengers that are present in the gastrointestinal tract and pain nerves.~   "
176616|NCT01253395|"~     Randomized equivalency trial of the effects of strength training compared to aerobic exercise~     on pain severity in adults with fibromyalgia.~   "
176617|NCT01253382|"~     The primary objective of this study is:~        -  assess the safety and tolerability of ecallantide in paediatric patients for acute~          attacks of HAE~      The secondary objectives are:~        -  evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for~          acute attacks of HAE~        -  assess the efficacy of ecallantide in paediatric patients treated for moderate to severe~          acute attacks of HAE~   "
176618|NCT01253369|"~     Pazopanib is a drug that inhibits proteins thought to be important for new blood vessel~     formation. This drug has been used in other cancer research studies and information from~     those studies suggests that pazopanib may help block proteins that are important for the~     growth, invasion, and spread of cancer cells.~   "
176619|NCT01253356|"~     The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing~     major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30~     days compared with standard care alone, while maintaining acceptable safety with respect to~     vascular accesss-related complications.~   "
176620|NCT01253343|"~     Violence and aggression on pediatric psychiatry units has led to staff and patient injuries~     and even deaths around the country. In an effort to improve safety, the investigators have~     developed a method (with the Brief Rating of Child and Adolescent Aggression) of identifying~     children and adolescents at a higher risk for aggression and violence on the units. In order~     to improve this prediction, the investigators plan to study salivary hormones in low risk~     children and high risk children. The salivary hormones to be studied include cortisol,~     testosterone, and dehydroepiandrosterone sulfate (DHEAS). The investigators expect to improve~     the investigators current ability to predict the severity and type of pediatric aggression~     and violence on the inpatient units by combining information from the Brief Rating of Child~     and Adolescent Aggression (BRACHA), the Predatory-Affective Aggression Scale (Vitiello et~     al., 1990), and salivary hormones.~   "
176621|NCT01253330|"~     The purpose of this randomized crossover study is to determine the efficacy of participant~     designed medication reminders on asthma control, asthma related quality of life,and~     medication adherence. In addition, this study will provide data regarding the usage,~     usability, acceptability of an online system designed for creating text message reminders. It~     is hypothesized that the teens receiving text message reminders will report having greater~     quality of life related to their asthma, a reported increase in the control of their asthma,~     and increased adherence to their medication regimen compared to those teens that are not~     receiving the text message reminders.~   "
176638|NCT01253109|"~     This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED~     Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome~     and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish®~     output signal peak after induced fluctuation by physical exercise or pupil dilation.~   "
176639|NCT01253096|"~     Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and~     safety of intratumorally administered L19IL2 in patients suffering from metastatic melanoma.~   "
176648|NCT01252979|"~     The current study is a prospective evaluation of the ability of ketosis to shift~     mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known mutation in their mtDNA~     at position 3243 (A>G). Subjects will be given supplemental medium chain triglycerides (MCTs)~     for a period of 6 months. mtDNA heteroplasmy will be measured 3 months prior to treatment, at~     treatment initiation, and 6 months after initiation.~      The primary objective of the current study is to determine if there is a shift in~     heteroplasmy in patients harboring the 3243 A>G mtDNA mutation to a more favorable (higher~     wild-type) profile while in a state of ketosis.~   "
176622|NCT01253317|"~     The investigators are recruiting children for a research study using a medication known as~     IGF-1 (mecasermin or INCRELEX) to see if it improves the health of children with Rett~     syndrome (RTT). To participate in the study your child must be female, between the ages of 2~     to 12 and have a genetic diagnosis (MECP2 deletion or mutation) of Rett Syndrome. As you may~     know, there is no treatment for this illness. Currently, the standard management of Rett~     syndrome is supportive, which means attempting to prevent complications and treatment of~     symptoms.~      This study involves testing an investigational drug, which means that even though IGF-1 is~     approved by the Food and Drug Administration (FDA) for use in children, it has not been used~     before to treat Rett syndrome specifically. Information from this research will help~     determine whether the drug should be approved by the FDA in the future for the treatment of~     Rett Syndrome.~      There are five major goals to this study:~        1. As one of the features of Rett Syndrome is unstable vital signs, the investigators are~          trying to determine if IGF-1 has any effect on normalizing your child's pulse, blood~          pressure and breathing pattern.~        2. The safety of IGF-1 in children with Rett syndrome. The study personnel will ask you to~          complete a medication diary and side effect reporting form on a regular basis. They will~          assist you in completing this by telephone interviews. Your child will undergo 2 lumbar~          punctures performed at the bedside in the clinical research facility. In addition,~          laboratory tests will be performed throughout the study to evaluate the safety of IGF-1.~          These will be blood tests similar to those provided in routine clinical care. Your child~          will undergo regular non-invasive comprehensive physical examinations including~          neurological and eye examination, tonsil evaluation, electrocardiograms (ECG),~          measurement of height, weight and head circumference.~        3. IGF-1 may improve your child's behavior, communication and speech. In order to measure~          this, the investigators will evaluate your child once during each month of treatment~          with neurodevelopmental assessments and a neurological exam. Investigators will also ask~          you about her behavior and day-to-day functioning through a structured parental~          interview and questionnaires.~        4. We will examine your child's cortical function through use of electroencephalography~          (EEG) in conjunction with presentation of visual and auditory stimuli. EEG is a~          non-invasive way of recording the electrical activity of your child's brain.~        5. Children with Rett Syndrome sometimes experience flushing in their cheeks or have~          exceptionally cold hands or feet and/or abnormal perspiration. The Qsensor® is a~          non-invasive device worn on a fabric bracelet that continually measures your child's~          perspiration level and body temperature. We would like to use the Qsensor® to determine~          whether or not IGF-1 improves these symptoms.~   "
176623|NCT01253304|"~     The primary purpose of this study is to help answer the following research questions, and not~     to provide treatment for any condition:~        -  To evaluate how much of the study drug (LY2189265) is in the blood of participants with~          varying degrees of liver impairment compared to those with normal liver function.~        -  To assess the safety of LY2189265 and any side effects that might be associated with it.~   "
176624|NCT01253291|"~     The objective of this study is to evaluate the safety and tolerability of 48 weeks~     subcutaneous dosing with LY2127399 for patients who have participated in a prior LY2127399~     clinical study. At the end of the 48 week treatment period, patients will participate in a 24~     week follow up period. Additional follow up after week 72 may continue to assess B cell~     recovery.~   "
176625|NCT01253278|"~     The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The primary~     purpose of a patient's participation in this study is to help answer the following research~     question(s), and not to provide treatment for diabetes:~        -  The safety of LY2393910 and any side effects that might be associated with it following~          2 weeks of doses~        -  How long it takes the body to absorb and remove LY2393910 following dosing over 2 weeks~        -  How daily dosing of LY2393910 affects blood levels of sugar (glucose), insulin and other~          naturally occurring substances in your body~        -  How daily dosing of LY2393910 affects the cells that produce insulin~        -  Any differences in the above between LY2393910 taken as daily doses in the morning or in~          the evening~   "
176626|NCT01253265|"~     The purpose of this study is to evaluate the safety and tolerability of multiple doses of~     LY2439821 in Japanese patients with rheumatoid arthritis.~   "
176627|NCT01253252|"~     The purpose of this study is to determine whether Positron Emission Tomography imaging can~     help to predict the evolutivity of AAA treated with endovascular prosthesis.~   "
176628|NCT01253239|"~     The purpose of this study is to evaluate the visual performance of two cohorts of patients~     who received multifocal intraocular lenses following cataract and clear lens extraction~     surgeries. Comparing visual outcomes of patients who were implanted with TECNIS Multifocal~     IOLs in both eyes versus patients implanted with TECNIS Multifocal in one eye and ReZoom~     Multifocal IOL in the opposite eye.~   "
176629|NCT01253226|"~     This study will evaluate the safety and tolerability of multiple doses of LY2127399 in~     Japanese patients with rheumatoid arthritis (RA).The study consists of a 20 week treatment~     period. All subjects will be followed up for 12 weeks after the last study drug~     administration.~   "
176630|NCT01253213|"~     The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2~     expression in human prostate by ultrasound molecular imaging.~      This will be compared with histopathology analysis (location based on expression of VEGFR2 in~     tissue specimens determined by immuno-histochemistry, IHC).~   "
176631|NCT01253200|"~     The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer®~     Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial~     flutter. This study will compare outcomes in patients treated with the Blazer® Open-Irrigated~     Ablation Catheter to outcomes in patients treated with open-irrigated radiofrequency ablation~     catheters that have received FDA market approval for the treatment of type 1 atrial flutter.~   "
176632|NCT01253187|"~     The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive~     containing drospirenone and ethinylestradiol) with or without levomefolate calcium~     (Metafolin, a registered vitamin supplement) in the body and to examine and compare the~     uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not~     using hormonal contraception~   "
176633|NCT01253174|"~     The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive~     containing drospirenone and ethinylestradiol) with or without levomefolate calcium~     (Metafolin, a registered vitamin supplement) in the body and to examine and compare the~     uptake of levomefolate calcium with or without Yasmin in the body, in healthy volunteers not~     using hormonal contraception.~   "
176634|NCT01253161|"~     The goal of this clinical research study is to learn if the study drug, Pasireotide LAR can~     shrink or slow the growth of Metastatic Neuroendocrine Carcinomas. The safety of this drug~     will also be studied. The patient's physical state, changes in the size of the tumor, and~     laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and~     effective.~   "
176635|NCT01253148|"~     The purpose of this study is to see if Therasphere will be a better way to treat~     cholangiocarcinoma. The investigators want to find out what effects, good and/or bad, this~     treatment will have on the patient and their cancer.~   "
176636|NCT01253135|"~     The objective of this study is to evaluate the potential inhibitory effects of HP802-247~     Vehicle on wound closure (healing), by comparing mean days to closure of superficial~     (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.~   "
176640|NCT01253083|"~     Background:~      - People who have cerebral palsy often have difficulty walking and moving their legs.~     Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which~     means that early motor skill development can be affected and can have repercussions for later~     development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury)~     have shown that it is important to start intensive therapy soon after the injury, and it may~     be true that starting intensive therapy at a young age will be helpful for children with~     cerebral palsy. Researchers are interested in testing the effectiveness of a special body~     weight support system for mobility training in young children who have or are at risk for~     cerebral palsy.~      Objectives:~      - To study the effectiveness of a mobility training program on the motor skills of young~     children who have or are at risk for cerebral palsy.~      Eligibility:~      - Children between 12 and 36 months of age who have delayed motor skills and either have been~     diagnosed with cerebral palsy or show evidence of spasticity or brain damage.~      Design:~        -  This study involves two 6-week study phases: a baseline phase and a mobility training~          program.~        -  Participants will be screened with a physical examination and medical history.~        -  During the baseline phase, participants will have mobility testing sessions once every 2~          weeks. These tests will measure motor development and ability, including ease and speed~          of walking.~        -  Participants' parents/guardians will receive a mobility sensor for the child to wear at~          home for at least 6 hours (awake time) to measure activity and mobility levels outside~          of the testing sessions.~        -  After 6 weeks of baseline testing, participants will have 6 weeks of mobility training~          for 30 minutes 3 days per week. Training will involve motor tasks with weight support,~          conducted by a pediatric physical therapist. Activities may include walking, climbing~          inclines or steps, or squatting to reach toys. All sessions will be videotaped.~        -  To evaluate the effects of the therapy program, participants will have testing sessions~          every 2 weeks.~        -  Parents/guardians will also complete questionnaires to provide feedback on the~          effectiveness of the therapy program.~   "
176641|NCT01253070|"~     This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating~     older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective~     treatment for AML.~   "
176642|NCT01253057|"~     Several epidemiological studies found that exposure to antineoplastic agents were associated~     with some reproductive, carcinogenic effects, higher rates of advance micronuclei (MN),~     sister-chromatic-exchange (SCE) and spontaneous abortion. Cleaning staff were potentially~     exposed to these agents while cleaning ward, ward toilet or other area.~      One medical center and one area hospitals in Taipei.Surface wipe samples were collected in~     the cleaning staff work area, such as ward environment and ward toilet. Urine and blood~     samples of subjects were collected for exposure examinations. Platinum-containing drugs~     (Cisplatin, Carboplatin, Oxaliplatin) were used as indicator drugs in environmental (surface~     wipe samples) and biological (urine and blood samples) samples.~      A self-administered questionnaire was used to collect demographic data, working practices,~     medical and contact history, and perceived work-related symptoms of cleaning staff.~      The results of this study will be to reduce exposure to cleaning staff.~   "
176643|NCT01253044|"~     This trial compares two psychotherapies, Acceptance and Commitment Therapy (ACT) and Present~     Centered Therapy (PCT), for veterans of the conflicts in Iraq and Afghanistan. We hypothesize~     that ACT will be more effective than PCT at reducing emotional distress and improving~     functioning. We further hypothesize that both interventions will be highly acceptable to~     participants.~   "
176644|NCT01253031|"~     Hearing loss is one of the most common health concerns affecting 1 in 3 Americans over 60~     years of age rising to 1 in 2 for those over 85 years old. Contributions to hearing abilities~     provided by cognitive and memory processes are universally recognized as essential to~     adequate speech communication, but these processes are not well understood. Cognitive~     limitations in the ability to rapidly process sequential sounds occur with all listeners but~     may have more impact on older Veterans with and without hearing impairment. The purpose of~     this study is to examine and more thoroughly characterize the change in auditory working~     memory with hearing loss and increasing age. Young and older listeners with and without~     hearing loss will listen and report on two target sounds embedded in a stream of rapidly~     occurring sound. The investigators expect that older listeners without hearing loss will have~     more difficulty than young listeners but that older listeners with hearing impairment will~     have the most difficulty with this task even when the sounds they are listening to are~     adjusted to compensate for their hearing loss.~   "
176645|NCT01253018|"~     Robotic devices are capable of providing therapy to the arm of patients with weakness due to~     stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of~     the weak arm for real life situations often remains limited. The goal of this study is to~     determine the best way to use robotic devices and functional task training to improve the use~     of the stroke affected arm for real life situations. A secondary goal of this study is to~     determine how or if specific areas of the brain are excited before and after training. The~     use of a safe and painless magnetic field directed at the brain called transcranial magnetic~     stimulation (TMS) will be used at set intervals to gain a better understanding of brain~     activity during recovery.~   "
176646|NCT01253005|"~     This study will investigate the effects of particle size of different triglyceride emulsions~     as well as the dynamics of intragastric structure formation and breakdown of the emulsions on~     GI function, the kinetics of the endocrine and the satiation response in healthy volunteers.~     12 healthy participants will be studied on four occasions on four separate days in a double~     blind randomized design~   "
176647|NCT01252992|"~     Tuberculous paradoxical reactions (PR) are immune reactions occurring during the course of~     antituberculous treatment and leading to a worsening of tuberculous symptoms after an initial~     improvement. This phenomenon has very extensively studied in HIV infected patients where it~     corresponds to the so called IRIS (immune reconstitution syndrome). However, it laso occurs~     in non immuno-compromized patients, especially those with extra-pulmonary localization of~     tuberculosis. The aim of the study is to look for risk factors of paradoxical reaction in non~     immuno-compromized patients with extra-pulmonary tuberculosis. The investigators will~     consider clinical, radiological and biological variables, including specific immune and~     genetic markers. Our secondary goals are to estimate the incidence of PR, describe their~     natural history; characterize the type of immune response they correspond to, and look for~     better diagnostic tools.The immunological characterization and the finding of predictive~     factors of PR, especially the genetic ones will allow a better understanding of biological~     mechanisms that lead to their occurrence during extra-pulmonary tuberculosis treatment. The~     establishment of predictive criteria could permit a better surveillance of at risk patients~     for a rapid treatment, or even a prevention of PR. The establishment of new diagnostic~     criteria at the time of PR could avoid numerous invasive diagnostic procedures, surgery~     and/or useless prolongation of antibiotic treatment.~   "
176649|NCT01252966|"~     This randomized clinical trial tested the effects of a computerized (web-based) cognitive~     training intervention on smoking cessation.~      All participants received 8 weeks of standard nicotine patch therapy, smoking cessation~     counseling, and were randomized to 1 of 2 different training programs: cognitive training vs.~     control training.~   "
176650|NCT01252953|"~     The Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL)~     trial aims to determine whether lipid modification with anacetrapib 100mg daily reduces the~     risk of coronary death, myocardial infarction (MI) or coronary revascularization~     (collectively known as major coronary events) in patients with circulatory problems who have~     their Low-density Lipoprotein (LDL) cholesterol level treated with a statin.~   "
176651|NCT01252940|"~     The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is~     to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate~     (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or~     fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor~     (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically~     suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment~     option to patients who wish to simplify dosing by reducing pill burden or to improve the~     tolerability of their treatment.~      Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which~     participants will switch treatment regimens at the start of the study, and the Stay on~     Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their~     baseline regimen during the first 24 weeks of the study (designed to provide an initial~     active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.~      After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF~     STR per protocol before switching to a commercially available source.~   "
176652|NCT01252927|"~     The main objective of the proposed study is to evaluate the efficacy of a gatekeeper training~     suicide intervention program, Applied Suicide Intervention Skills Training (ASIST), in~     improving medical students' knowledge about suicide intervention, impact of attitudes on~     someone at risk for suicide and competent use of intervention skills to recognize risk and~     intervene effectively compared to medical education as usual. This research project will be~     undertaken using a randomized-controlled trial design. Questionnaires and objective~     structured clinical examinations using simulated patients will be completed at three time~     points: 1) before training, 2) after training, and 3) at one year following the training.~     Medical students' clinical skills in recognizing risk and intervening with simulated~     patients, as well as knowledge about suicide intervention and the impact of attitudes on~     someone at risk for suicide will be evaluated.~   "
176653|NCT01252914|"~     The purpose of this study is to assess the efficacy and safety of one iStent supra stent in~     the reduction of intraocular pressure associated with primary open-angle glaucoma.~   "
176654|NCT01252901|"~     The Wilms' tumor suppressor gene 1 (WT1) encodes for a transcription factor which plays an~     important role during urogenital development. Patients carrying a WT1 germline mutation show~     symptoms like proteinuria, Wilms tumors, genital malformations and kidney failure. Milder~     variants are possible and classification is not always possible. In this registry we are~     collecting detailed clinical data of affected individuals to establish genotype-phenotype~     correlations with the greater goal to optimize patient care.~   "
176655|NCT01252888|"~     The purpose of this study is to assess efficacy and safety of two iStents for the reduction~     of intraocular pressure associated with primary open-angle glaucoma.~   "
176656|NCT01252875|"~     The aim of this study is the evaluation of two usual care strategies after stroke or TIA :~     achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will~     use the statin and titrate the dosage to achieve the target assigned by randomization in~     monotherapy or in combination with ezetimibe or other drugs.~      The primary end-point is the occurrence of recurrent non fatal stroke, non fatal MI, and~     vascular death in each group.~      3760 patients will be recruited and followed for eight and a half years maximum.~   "
176657|NCT01252862|"~     The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of~     two iStent devices in eyes of subjects with primary open-angle glaucoma~   "
176658|NCT01252849|"~     The purpose of this study is to evaluate the safety and efficacy of the iStent medical device~     that is implanted into the eye and designed to reduce eye pressure in patients with your~     condition.~   "
176659|NCT01252836|"~     Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.~   "
176660|NCT01252823|"~     The purpose of this study is to use implantable loop recorder (ILR) in patients under chronic~     hemodialysis to record arrhythmias and conduction disorders and correlate them with~     hemodialysis parameters.~   "
176661|NCT01252810|"~     To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when~     compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either~     chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive~     heart failure (CHF) NYHA Class III or greater, who are referred for a coronary~     catheterization procedure with or without PCI.~   "
176662|NCT01252797|"~     This study will investigate the safety, tolerability, and effectiveness of changing the order~     of receiving radiation therapy for treating brain cancer. The investigators hope that~     changing the sequence of radiation therapy will lower the risk of cancer spreading throughout~     your spinal fluid, which covers your brain and spinal cord.~   "
176663|NCT01252784|"~     The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity~     conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with~     higher risk MDS.~   "
176664|NCT01252771|"~     The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM)~     in the hemodialysis patient population. This computerized algorithm model was developed as a~     tool to aid physicians in controlling a hemodialysis patient's phosphate level. Once a~     subject consents to participate in the study, the subject's dietary phosphate intake will be~     estimated by the modeling program and the appropriate dose of the phosphate binder calcium~     acetate (PhosLo) will be recommended accordingly. If necessary, the Ca++ concentration of the~     dialysate will be changed to remove any excess calcium absorbed as the result of an increase~     in the PhosLo prescription to control phosphorus.~   "
176665|NCT01252758|"~     The drug product albuterol sulfate DPI, TBS-7, is a single dose inhalation product of~     albuterol sulfate containing 240 ug albuterol sulphate (200 ug of albuterol) and inhalation~     grade lactose in a new dry powder delivery system called the Trivair deposition system.~      Three different doses of albuterol sulfate DPI, TBS-7, will be administered in this dose~     ranging clinical trial: an optimal dose, 80% of the optimal dose and 50% of the optimal dose~     and will be compared with placebo and an active comparator.~   "
176666|NCT01252745|"~     This clinical trial will compare the pharmacokinetic profile of testosterone after repeated~     intranasal administration of TBS-1 of different strengths in subjects with hypogonadism~   "
176667|NCT01252732|"~     The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of~     oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic~     benefit of oritavancin administered as a single 1200 mg IV dose.~   "
176668|NCT01252719|"~     The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of~     oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic~     benefit of oritavancin administered as a single 1200 mg IV dose.~   "
176669|NCT01252706|"~     The aims is to evaluate the rate of exposure to alcohol, psychoactive substance and nicotine~     among pregnant women in periphery hospital (Poria) and in the center of Tel Aviv (Ichilov)~     and to evaluate study Brief Intervention impact on reduction exposure, and its effect on~     newborn outcomes.~   "
176670|NCT01252693|"~     The aim of this study is to assess the safety and efficacy of a monthly regimen of ozarelix~     administered subcutaneously (SC) versus Goserelin depot administered subcutaneously in men~     with Prostate Cancer. This is an international, multi-center, randomized, open label 84 days~     study. Men who are at least 18 years of age or older, with histologically proven prostate~     cancer of all stages, in whom endocrine treatment is indicated will be eligible for study~     entry.~   "
176671|NCT01252680|"~     This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in~     healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A~     vaccines were evaluated.~   "
176672|NCT01252667|"~     This phase II trial studies the side effects and how well clofarabine works when given~     together with low-dose total-body irradiation (TBI) in treating patients with acute myeloid~     leukemia (AML) undergoing donor peripheral blood stem cell transplant (PBSCT). Giving~     chemotherapy and TBI before a donor PBSCT helps stop the growth of cancer cells. It may also~     stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets.~   "
176673|NCT01252654|"~     Emtosecond lasers are used in cutting the flap in LASIK procedures (laser corrective surgery~     for refractive error). Their use has decreased the incidence of serious complications when~     compared to the use of microkeratomes(mechanical blades). The commonest femtosecond laser~     currently used is 'Intralase'. A newer femtosecond laser 'Visumax' (Zeiss) is now available~     and differs from the Intralase in that it does not interfere with the curvature of the cornea~     when creating the flap. The Intralase applanates the cornea flat during flap creation which~     causes the intraocular pressure to be higher. Both Intralase and Visumax lasers are available~     to patients and surgeons to use at SNEC. The aim of the investigators study is to compare the~     two lasers in a randomization of left and right eyes in the same patient. The investigators~     want to measure any difference that the lower intraocular pressure may have during the~     creation of the flap. This will be measured with a questionaire on patient experience during~     the procedure and the outcomes of vision, refraction, contrast sensitivity, wave-front~     analysis, tear function,corneal sensation and flap thickness measured with anterior segment~     OCT during the post-operative follow up period. To date no-one has compared the use of these~     two femtosecond lasers. Both lasers are currently used clinically for flap creation at SNEC.~   "
176674|NCT01252641|"~     This research study is being carried out to study a new way to possibly treat human~     immunodeficiency virus (HIV). The agent is called SB-728-T which are CD4+ T-cells obtained~     from an individual that are genetically modified at the CCR5 gene by Zinc Finger Nucleases.~     The CCR5 gene is required for certain types of HIV to enter into and infect T-cells. T cells~     are one of the white blood cells used by the body to fight HIV. The most important of these~     are called CD4+ T-cells~      Some people are born without the CCR5 gene on their T-Cells. These people remain healthy and~     are resistant to infection with HIV. Other people have a low number of CCR5 genes on their~     T-cells and their HIV disease is less severe and is slower to cause disease (AIDS).~      The purpose of this research study is to find out whether SB-728-T is safe to give to humans~     and find out how this affects HIV.~   "
176675|NCT01252628|"~     The purpose of this Phase 1/2 open-label study is to determine the safety and efficacy of a~     cetuximab and PX-866 combination treatment. In the Phase 1 part of the study, the dose of~     PX-866 to be given in combination with cetuximab will be determined in patients with~     incurable metastatic CRC or incurable progressive, recurrent or metastatic SCCHN. The Phase 2~     part of the study is a randomized evaluation of the antitumor activity and safety of PX-866~     in combination with cetuximab versus cetuximab alone in patients with either incurable~     metastatic CRC who have a history of progression or recurrence following prior irinotecan and~     oxaliplatin containing regimens or are intolerant of irinotecan (Group 1) or incurable~     progressive, recurrent or metastatic SCCHN (Group 2).~   "
176676|NCT01252615|"~     The goal of this study is to compare a patient only to a patient+partner intervention on~     recovery outcomes of patients and partners after Implantable Cardioverter Defibrillator (ICD)~     implantation.~   "
176677|NCT01252602|"~     The purpose of this prospective cohort study is to search for a relationship between maternal~     depression in the third trimester, as indicated by a score of > 12 on the EPDS, and a choice~     not to breastfeed at all, defined as no breastfeeding after dismissal from the hospital. The~     investigators hypothesize that women who screen positive for prenatal depression will be~     significantly less likely to breastfeed their babies after discharge from the hospital~     following childbirth.~   "
176690|NCT01252433|"~     The purpose of this research is to investigate children's responses to incorporating~     vegetables into selected entrees and snacks over several days. The hypothesis is that~     children will increase their vegetable intake by consuming foods that have been reduced in~     energy density through the addition of vegetables. Effects on energy intake will also be~     examined.~   "
176678|NCT01252589|"~     Although the impact of disease and treatment related burden on health-related quality of life~     (HRQOL) in patients with solid tumours has been well studied, with several clinical trials~     that included HRQOL as an endpoint, the general understanding in patients with Chronic~     Myeloid Leukaemia (CML) is lacking in comparison.~      The literature shows that patients' perspective is unique and should always be measured with~     methodologically sound instruments that are devised for this purpose.~      The main scope of this project is develop to an international validated questionnaire for the~     purpose of HRQOL assessment; such a tool will then be used to provide important data, from~     the patients' perspective, to make more informed treatment decisions.~   "
176679|NCT01252576|"~     300 italian women will be enroll for linguistic and cultural validation in italian of Female~     sexual function index (FSFI). This questionnaire is used in most countries to investigate~     female sexual function. To date there are not validate questionnaires in italian on female~     sexual function. We decided to start the validation process to give a validated tool to~     italian investigators.~   "
176680|NCT01252563|"~     In this survey, to collect the safety and efficacy information in the subjects who have been~     treated with amlodipine 5mg at least 4 weeks in daily practice.~   "
176681|NCT01252550|"~     The purpose of this study is to investigate the association between gut microbiota,~     immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to~     assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge~     test in IBS patients.~   "
176682|NCT01252537|"~     Background: Tuberculosis (TB) and HIV are leading causes of disease and death in Subsaharan~     Africa. Antiretroviral therapy (ART) dramatically improves prognosis in HIV infection, but TB~     is still a common complication in HIV-infected subjects. Management of TB-HIV co-infection is~     complex, both with regard to diagnosis and treatment. Since scaling-up of ART requires~     management of most patients in primary health care, it is critical to achieve better~     strategies for TB-HIV co-infection at peripheral levels of the health care system in endemic~     regions. This includes development of new methods to assess the severity of HIV disease and~     the need to start ART during TB treatment in this population.~      Aims: To compare a scoring system for clinical signs of immunosuppression with CD4 cell~     counts to assess HIV disease severity and indications for ART initiation, and to correlate~     immunosuppression status with treatment outcome.~      Workplan: CD4 cell levels and results of clinical scoring has been compared in 1100 patients~     with TB, using HIV-negative subjects with TB treatment for control. Inclusion was closed in~     February 2012, and follow-up of participants completed in August 2012. Plasma levels of~     immune activation and inflammatory markers will be correlated with the degree of~     immunosuppression.~      Significance: TB is the most significant clinical challenge to the successful scaling-up of~     ART in Africa. In order to improve management in primary health care it is necessary to find~     robust and reliable techniques for determining disease severity and identification of~     patients who need to start ART during TB treatment. This study may contribute to increased~     knowledge in this field and help to modify guidelines for management of TB-HIV co-infection~     in Ethiopia as well as in other resource-limited settings.~   "
176683|NCT01252524|"~     The purpose of this study is to determine whether a form of fiber if effective in improving~     the treatment of type 2 diabetes. Measurements of other possible medical benefits will~     include blood pressure, cholesterol, weight, and the number/dosage of medications used for~     diabetes, hypertension, and high cholesterol.~   "
176684|NCT01252511|"~     The purpose of this study is to determine whether or not the length of the biliopancreatic~     limb of the Roux-en-Y anastamosis plays a critical role in the development of malabsorption~     after gastric bypass for treatment of severe obesity.~   "
176685|NCT01252498|"~     This study will evaluate the role of cyclooxygenase pathways in radiation-induced and~     chemoradiation-induced mucositis.~   "
176686|NCT01252485|"~     This is a registry study in adult patients with newly diagnosed or refractory/relapsed~     myeloid neoplasms~      Investigator's sites: 60-70 sites in Germany and Austria~      Estimated duration of observation of an individual patient:~      10 years maximum~      Objectives~        -  To register all patients with acute myeloid leukemia and related precursor neoplasms,~          acute leukemia of unambiguous lineage, with higher risk myelodysplastic syndromes (MDS~          with excess blasts 2), and with myeloid neoplasms with germline predisposition, newly~          diagnosed or relapsed/refractory in all participating centers (completeness)~        -  To perform timely analyses of disease-related genetic markers (incidences, treatment~          recommendations)~        -  To assess patient and family history, clinical characteristics and outcome data~          (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence~          of death [CID], overall survival [OS])~        -  To assess biological disease features and correlate with clinical outcome data~          (prognostic and predictive markers)~        -  To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue,~          e.g., skin biopsy, buccal swap, finger nails, hairs, or sputum)~        -  To assess quality of life~   "
176687|NCT01252472|"~     Some men who have a history of use of Tamsulosin (Flomax) are at risk for a condition called~     Intraoperative Floppy Iris Syndrome that can develop during otherwise routine cataract~     surgery. It is not fully understood why this condition develops or who is at risk for~     developing it. In this study the investigators will take pictures of the iris and iris blood~     vessels before cataract surgery. The investigators hope that the results of this study will~     provide a better understanding of how Intraoperative Floppy Iris Syndrome develops and give~     us a non-surgical way of figuring out who might develop this problem during surgery.~   "
176688|NCT01252459|"~     This study is designed to evaluate the impact of radiotherapy target volume delineation based~     on AA-PET compared to target volume delineation based on contrast enhanced T1 weighted MRI~     (T1Gd-MRI) on the clinical outcome of patients with recurrent glioblastoma (GBM) as well as~     concerning therapeutic safety of the respective strategy.~   "
176689|NCT01252446|"~     This article reviews social-demographic variables (SDV) including interpersonal and academic~     and social performance in families and comorbid conditions(CC) which are the most associated~     with Attention-Deficit/Hyperactivity Disorder (ADHD)in the sample that has been confirmed~     diagnosis of ADHD and sample with the same symptoms but not confirmed diagnosis of ADHD.~      There are no reports of this kind in the Norwegian population with ADHD.~   "
176693|NCT01252394|"~     The study aims to investigate the correspondence between changes in central venous oxygen~     saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients with~     an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac output~     measurements during ongoing hemodialysis. Provided this validation is satisfactory, impedance~     cardiography cardiac output and ScO2 will be measured at intervals during hemodialysis in 25~     hemodialysis patients with a central vascular access. Absolute values and trends will be~     compared.~   "
176694|NCT01252381|"~     The aim is to investigate the importance of vitamin D levels to achieve the effect of~     strength training. If we can show that vitamin D has an effect of training, the ultimate goal~     is to find out why and how vitamin D affects muscle.~      This would potentially have important implications for public health. Since a large number of~     populations, including elderly, are shown to have too little vitamin D and also has low~     muscle strength, it will be essential that these people added vitamin D in relation to~     training and rehabilitation.~   "
176695|NCT01252368|"~     Aim of this trial is to investigate the expression and localisation of different amino acid~     transporters and their regulatory proteins derived from the regulatory proteins of the local~     renin angiotensin system (RAS) in the intestine. This is investigated on one hand in patients~     who do not take any drugs interfering with RAS. On the other hand expression analysis is done~     in patients taking daily RAS-active drugs, like ACE inhibitors or sartanes.~      After obtaining informed consent of patients attending the hospital for clarification of~     gastrointestinal symptoms by gastroduodenoscopy or colonoscopy, 2 biopsies (in addition to~     biopsies needed for clinical diagnostics) will be taken from each duodenum, jejunum, ileum~     and descending colon.~      Biopsies are investigated anonymously at the Institute of Physiology of the University of~     Zurich. The mRNA content of amino acid transporters and regulatory proteins, respectively, in~     the biopsies is analyzed by quantitative PCR. Transport proteins are in addition analyzed~     with immunohistochemistry.~      Furthermore amino acid concentration in plasma and urine samples are analyzed by HPLC. From~     plasma and serum samples RAS parameters like renin, aldosterone, ACE and angiotensin(1-7) are~     measured.~   "
176696|NCT01252355|"~     The primary objective was to demonstrate the effect of teriflunomide, in comparison to~     placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of~     MS who are treated with Interferon-beta (IFN-beta).~      The secondary objectives were:~        -  Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:~             -  Disease activity as measured by brain Magnetic Resonance Imaging (MRI)~             -  Disability progression~             -  Burden of disease and disease progression as measured by brain MRI~        -  Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy~        -  Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta~          therapy~        -  Assess associations between variations in genes and clinical outcomes (safety and~          efficacy)~        -  Assess other measures of efficacy of teriflunomide such as fatigue and health-related~          quality of life~        -  Assess measures of health economics (hospitalization due to relapse, including the~          length of stay and any admission to intensive care unit)~   "
176697|NCT01252342|"~     Oxytocin use has become routine practice in elective cesarean delivery to promote uterine~     contraction and reduce blood loss. However, there is a lack of consensus regarding the best~     dose of oxytocin and the most effective route of administration. Most dosage and delivery~     systems have been empirically derived.~      It is currently our practice at the Royal University Hospital to start an oxytocin infusion~     (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous~     oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also~     choose to inject bolus oxytocin directly into the uterus (intramyometrial).~      The primary objectives of the study include:~        1. Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to~          prevent need for additional uterotonics, including additional oxytocin;~        2. Determine if the addition of prophylactic intramyometrial oxytocin improves both the~          primary outcome (uterine tone) and secondary outcomes (estimated blood loss,~          preoperative to postoperative change in hematocrit, need for additional uterotonics, and~          need for blood pressure support); and~        3. Act as a dose finding study to determine if the intramyometrial dose is sufficient to~          augment uterine contraction.~      The working hypothesis is that the use of intramyometrial oxytocin will not improve primary~     or secondary outcomes compared to the current practice of an oxytocin infusion alone.~   "
176698|NCT01252329|"~     This study will evaluate if there is a difference in survival between elective treatment of~     draining lymph nodes vs. clinical nodal observation in patients undergoing Mohs surgery for~     high risk skin squamous cell carcinoma of the head and neck who have a normal lymph node~     exam. Each treatment arm is accepted as a current standard of care, and the objective is to~     compare outcomes between the two arms.~   "
176699|NCT01252316|"~     Each year in the United States, 300,000 people suffer from Cardiac Arrest (CA), and of them~     there is a 90% mortality rate. Out-of-Hospital arrests in particular have a 1-5% survival to~     hospital discharge. High quality CPR is crucial to lowering the mortality rate and increasing~     survival, yet only 15-30% of out-of-hospital CA victims receive bystander CPR. Studies have~     shown that prompt administration of CPR dramatically improves outcomes. In a recent study~     from Switzerland, lay bystander CPR doubled the survival rate at one month. Our study will~     look to train family members of at-risk cardiac patients in the skills of CPR through the~     American Heart Associations (AHA) CPR Anytime Friends and Family Personal Learning Program~     (CPR Anytime) to see if these family members are able to learn and perform quality CPR in the~     event that their family member should suffer a cardiac arrest. The unique feature of the CPR~     Anytime training is that it is a low-cost, self-learning, video-based program that can be~     completed in under 30 minutes, saving the time and expense of traditional CPR training~     courses. While initial work has proven that teaching CPR in hospital using the VSI kit is~     feasible, little research has been conducted to make the program sustainable.~   "
176700|NCT01252303|"~     The study is to determine the effect of a behavioral weight loss program supplemented with~     Nutrisystem meal replacements on weight, blood pressure, fasting blood glucose, and blood~     lipids levels over 12 weeks.~   "
176701|NCT01252290|"~     This study is designed to gather information on how the prescription drug Lovaza™ which~     contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.~     This drug is currently approved by the FDA for reducing blood levels of triglycerides.~   "
176702|NCT01252277|"~     This study is designed to gather information on how the prescription drug Lovaza™ which~     contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.~     This drug is currently approved by the FDA for reducing blood levels of triglycerides.~   "
176703|NCT01252264|"~     The purpose of this study is to find out if there are any genetic differences between people~     with and without disorders of the head, face, and eye. We will create a biorepository of~     samples from people with and without these types of birth defects. A biorepository is a~     collection or bank of human tissue materials (such as blood or saliva) for research~     purposes. These samples will then be available to investigators studying these disorders.~   "
176704|NCT01252251|"~     The purpose of this study is to find out what effects, good and/or bad, the drugs everolimus~     and pasireotide have on the patient and on melanoma. Pasireotide is also called SOM-230.~     Pasireotide is an experimental drug and is not approved by the Food and Drug Administration.~     Everolimus is also called RAD001. Everolimus is approved for use in the U.S. for kidney~     cancer. Everolimus is not approved for treatment of melanomas, but early studies show that it~     may help some patients with melanoma.~   "
176705|NCT01252238|"~     This study is an investigation of the effect of commonly prescribed anti-hypertensive agents~     on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are~     as follows:~      Specific Aim 1: To determine in insulin resistant, hypertensive subjects if renin inhibition~     for 12 weeks modifies glucose homeostasis and insulin sensitivity.~      To accomplish this specific aim, we will use three approaches: a fasting HOMA Index; and a~     three hour glucose tolerance test. Only hypertensive subjects with insulin resistance, as~     assessed by HOMA index will be enrolled in the study. Insulin resistance will be assessed~     basally and after twelve weeks of treatment with either a calcium channel blocker with~     placebo, or calcium channel blocker with a renin inhibitor, or a calcium channel blocker with~     a renin inhibitor and an angiotensin receptor antagonist.~      Specific Aim 2: To determine in insulin resistant, hypertensive subjects if renin inhibition~     for 12 weeks modifies diastolic function and aortic compliance response to dietary sodium~     intake.~      The same protocol and subjects will be used as defined in Specific Aim 1. Myocardial~     relaxation velocity (tissue Doppler imaging at the mitral annulus) and aortic compliance~     (characteristic aortic impedance) will be measured at baseline and then after acute and~     chronic renin inhibition:~        1. Acute effect of renin inhibition: Hemodynamic measurements will be obtained on both high~          and low dietary sodium intake conditions (~1 week each) before and after a single dose~          of a renin inhibitor.~        2. Chronic effect of renin inhibition: Hemodynamic measurements will be obtained at~          baseline and after 12 weeks of each of the three drug treatment arms above.~      The study lasts 12 weeks and plans to study 45 hypertensive adults over the next two years.~   "
176706|NCT01252225|"~     People cough in order to clear their airways. Most coughs are caused by viruses and settle~     down by themselves, but some people develop persistent coughing which can be anywhere from 8~     weeks to several years. This is called chronic cough. People with chronic cough find the~     symptom distressing and it can have a major impact on their quality of life. Patients with~     chronic cough often report a sensation at the back of their throat which makes them feel an~     urge to cough. There is some evidence that Lidocaine (an anaesthetic used during medical~     procedures) can suppress a person's cough when given to patients via a nebuliser (a machine~     that turns liquid into a fine mist).~      It is currently unknown whether using a local anaesthetic, such as Lidocaine, in the form of~     a throat spray would successfully suppress a person's cough. A throat spray would be an~     easier treatment option in chronic cough patients. Thus, the investigators research aims to~     compare cough rates, severity and urge to cough scores between Lidocaine throat spray and~     nebulised Lidocaine.~   "
176707|NCT01252212|"~     In this project, we will work directly with underserved patients in a safety-net setting to~     conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel~     adherence intervention embedded in an existing PHR that uses cellular phone short message~     service (SMS) reminders and patient responses to the reminders. We will compare adherence~     rates in both arms as assessed by antiretroviral medication concentrations in hair samples~     and self-report; clinical outcomes will also be compared in the two arms. The project will~     examine medication adherence for antiretroviral medications and treatments of common~     conditions such as depression, hypertension, diabetes and hypercholesterolemia.~   "
176708|NCT01252199|"~     This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered~     concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB)~     Infection.~   "
176709|NCT01252186|"~     This study is being conducted to evaluate the impact of a 91-day extended cycle oral~     contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in~     healthy women.~   "
176710|NCT01252173|"~     The purpose of this research is to measure the endotracheal tube cuff pressure in patients~     who have been endotracheally intubated emergently in the emergency department or in the field~     by prehospital personnel. Overinflation of ETTc pressure is associated with injury, and we~     seek to determine if the phenomenon of excessively inflated ETTc can be detected in~     endotracheally intubated patients in the ED.~      There is no experimental aspect to this study, it is only descriptive. Measurement of ETTc~     pressure is already performed by respiratory therapy/respiratory care. We simply seek to~     assess these measurements to determine if any patients in fact have high ETTc pressure. If it~     is found that patients do have ETTc with high pressures, this might allow emergency~     department staff or prehospital personnel such as paramedics or EMTs to use this information~     to seek methods by which endotracheal intubation can be improved and patients can be~     intubated without excessive ETTc pressure.~      This is a pilot study. We have conducted several in vitro studies, which have all~     demonstrated that paramedics, EMTs, and emergency department physicians practice endotracheal~     intubation in a method that might result in excessively inflated ETTc.~   "
176711|NCT01252160|"~     In this study all patients will be treated with the same medicine, the QUTENZA patch.~     Subjects will receive up to 6 QUTENZA patch applications over 12 months.~   "
176712|NCT01252147|"~     This study will evaluate the inter-rater and intra-rater reliability of the Global Eyelash~     Assessment (GEA) scale with photonumeric guide in Japanese subjects.~   "
176713|NCT01252134|"~     The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone~     hydrogel (SiH) contact lens with three marketed contact lens care solutions.~   "
176715|NCT01252108|"~     Helicobacter pylori infection of the gastric epithelium is the most common bacterial~     infection worldwide. Its global prevalence is estimated at 50%, though the burden falls~     disproportionately on the developing world, where the prevalence in some areas is 80%. H.~     pylori infection is generally acquired during childhood, and without specific antibiotic~     treatment can persist for life. The infection is generally clinically asymptomatic during~     childhood, and even in adulthood 80-90% of infected individuals will remain asymptomatic~     (although they may transmit the bacteria).~      SQ109 is a new, small molecule antibiotic with characteristics that make it particularly~     attractive to evaluate against H. pylori. In brief, SQ109 is orally bioavailable,~     acid-stable, has in vitro activity against H. pylori and achieves high intracellular~     concentration (which may be important to effect bacterial eradication).~      Based on the antimicrobial activity and clinical safety, SQ109 will be evaluated in this~     clinical trial to assess safety and antimicrobial activity in adults infected with H. pylori.~     Data from this study will help determine whether larger safety and efficacy studies in~     individuals with H. pylori-associated duodenal ulcer disease are warranted.~   "
176716|NCT01252095|"~     This first-in-human study aims to establish the maximum tolerated dose of PG545 and to~     evaluate its safety in subjects with advanced solid tumours. In addition the study will~     explore whether PG545 exposure results in changes to chemicals produced by the body that are~     associated with cancer growth and spread.~   "
176717|NCT01252082|"~     The purpose of this study is to determine whether nonsurgical periodontal therapy is~     effective in the metabolic control of patients with type II Diabetes mellitus.~   "
176718|NCT01252069|"~     This is the long-term extension of a phase III, efficacy and safety open-label (protocol~     PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the~     administration of progestin or placebo tablets after end of PGL4001 treatment.~      This extension study consists of three periods of 3 months open-label PGL4001 treatment, each~     followed by ten days of double-blind treatment with progestin or placebo and then a period~     without treatment.~   "
176719|NCT01252056|"~     The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic~     nephropathy is better than the single use.~   "
176720|NCT01252043|"~     The investigators will try to predict the risk of esophageal varices (EVs) in long-term BA~     survivors using noninvasive computed tomography (CT) or magnetic resonance (MR) indices and~     the measurement of transverse diameters of paraesophageal and gastroesophageal veins.~   "
176721|NCT01252030|"~     In this study, 80 coronary artery disease patients with successful coronary revascularisation~     (by CABG or PCI) will be included. Patients are excluded in case of: congestive heart~     failure, ICD or pacemaker, any disability limiting exercise participation.~      These patients are attending phase 2-3 cardiac rehabilitation, and have completed 6 weeks of~     rehabilitation. Next, subjects are randomly assigned to a control group or an intervention~     group.~      Outcome parameters: physical activity, exercise capacity, blood glucose, insulin level and~     lipid profile, body weight and waist circumference, cardiovascular morbidity and mortality.~      Hypothesis: telemonitoring of physical activity will increase physical activity, and improve~     cardiovascular disease risk factors, in CAD patients attending phase 2-3 cardiac~     rehabilitation.~   "
176722|NCT01252017|"~     The purpose of this study is to determine whether nilotinib is effective in the prophylaxis~     and treatment of CMV reactivation in allo-HSCT patients.~   "
176723|NCT01252004|"~     Tako Tsubo syndrome (TTS) is characterized by the occurrence in the context of mental or~     physical stress, a clinical and ECG of acute myocardial infarction without significant~     coronary artery stenosis, accompanied by a disorder Acute, reversible left ventricular who~     takes on a characteristic apical ballonnisation evoking the image of a Japanese octopus trap~     called Tako (octopus) tsubo (jar). Pathophysiology of unknown changes immediate~     life-threatening prognosis is often good in the longer term.~   "
176724|NCT01251991|"~     Despite improved treatment, cardiovascular disease remains one of the most common diseases~     and causes of death in the Western world. Hypercholesterolemia is a well known risk factor~     for developing cardiovascular disease. Prevention and treatment are based in part on lowering~     LDL cholesterol. Dietary and lifestyle changes always play an important part of the treatment~     and preventive effort, and conversion to a heart-healthy diet reduces LDL cholesterol by a~     mean 10%. Further lowering of LDL cholesterol by means of food supplements have been~     demonstrated in numerous studies. Cholesterol lowering food supplements include isolated soy~     protein and water soluble dietary fibre such as psyllium husks. Postulated mechanisms of~     action responsible for the cholesterol lowering in these two food supplements are different,~     so there is a reason to expect an additive cholesterol lowering effect during concomitant~     treatment with both substances. The investigators want to investigate whether concomitant~     treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet~     results in a significantly greater reduction of LDL cholesterol in hypercholesterolemia, than~     single treatment with each of the substances.~   "
176725|NCT01251978|"~     Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients~     with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help~     reduce the number of laser treatments that might be needed to control the tumor.~   "
176726|NCT01251965|"~     The goal of this clinical research study is to find the highest tolerable dose of ruxolitinib~     that can be given to patients with acute leukemia and to learn if the study drug can help~     control the disease. The safety of the drug will also be studied.~   "
176727|NCT01251952|"~     The primary goal of this study is to determine the feasibility and safety of giving two doses~     of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a~     dose escalation fashion. Secondary goals include evaluating the the effect of DD on the~     number and percentage of T-regs in the peripheral blood post transplant at each dose level,~     the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and~     determining the time to engraftment: absolute neutrophil count (>0.5 x 10^9/L for 3~     consecutive days), and platelet (>20X 10^9/L for 3 consecutive days).~      The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently~     enhance the immune reconstitution and reverse post transplant lymphopenia. This may~     indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.~   "
176728|NCT01251939|"~     Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants.~     Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and~     splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be~     helpful to measure effects of ibuprofen treatment for PDA in preterm infants.~   "
176729|NCT01251926|"~     Background:~      - The anticancer drug bevacizumab works by reducing the formation of new blood vessels in~     tumors, which can slow or stop the growth of cancer cells and supporting blood vessels. The~     experimental drug EZN-2208 works by limiting how well cancer cells can divide. Drugs similar~     to EZN-2208 also work by turning off the production of the HIF protein, which otherwise can~     help cancer cells to grow even when blood supply is limited. Researchers are interested in~     determining if EZN-2208 turns off HIF in patient tumors, and whether combining it with~     bevacizumab is an effective treatment for cancers that have not responded to standard~     treatment.~      Objectives:~      - To assess the safety and effectiveness of the combination of EZN-2208 and bevacizumab for~     solid tumors that have not responded to standard treatment.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors that have not responded to~     standard treatment.~      Design:~        -  Participants will be screened with a full physical examination and medical history,~          blood and urine samples, and tumor imaging studies.~        -  Participants will receive EZN-2208 and bevacizumab intravenously on an outpatient basis~          in 4-week cycles (with the exception of the first cycle, which will be 5 weeks).~        -  Cycle 1: Participants will receive EZN-2208 once a week for 3 weeks in a row (days 1, 8,~          and 15), followed by 1 week without the drug. Participants will receive bevacizumab 1~          week before EZN-2208 (day - 7) and then 3 weeks later (day 15).~        -  Subsequent cycles: Participants will receive EZN-2208 once a week for 3 weeks in a row~          (days 1, 8, and 15), followed by 1 week without the drug. Participants will receive~          bevacizumab every 2 weeks (days 1 and 15).~        -  Participants will have clinic visits with physical examinations and blood tests in the~          first 3 weeks of each cycle. Clinic visits may also include tumor imaging studies and~          tumor biopsies as directed by the study researchers.~        -  Participants will continue to take the study drugs for as long as the tumor shrinks or~          does not grow, and as long as they do not experience intolerable or unsafe side effects~          from the drugs.~   "
176730|NCT01251913|"~     Background:~      - An important new area of brain tumor research is the development of tumor and brain stem~     cell lines. Successful growth of these cell lines requires obtaining large volumes of fresh~     tumor and brain tissue, which is best accomplished by harvesting whole brains from recently~     deceased patients. These cell lines will help researchers understand how these tumors develop~     and will also help identify new targets for treatment. Researchers are interested in~     conducting a pilot study of planned inpatient hospice care with timely brain tumor tissue~     harvest at the time of death.~      Objectives:~        -  To provide high-quality end of life inpatient hospice care for patients with untreatable~          brain tumors.~        -  To procure brain and tumor tissue shortly after time of death in order to derive viable~          tumor and neural stem cell lines for research purposes.~      Eligibility:~        -  Individuals at least 18 years of age who have an untreatable primary brain or central~          nervous system tumor, are able to give informed consent (either their own or through a~          designated power of attorney), and have agreed to a Do Not Resuscitate order and Consent~          for Autopsy as part of the end-of-life care plan.~        -  HIV-positive individuals or those suspected of having infectious cerebritis are not~          eligible because of the potential for contamination of brain tissue.~      Design:~        -  Participants will be enrolled in inpatient hospice admission to the National Institutes~          of Health Clinical Center either from home or from an outside hospital once a study~          investigator estimates an expected survival of less than 2 weeks.~        -  Participants will receive palliative care at the Clinical Center. Care will be tailored~          to each participant depending on the information provided in the individual's~          end-of-life care plan.~        -  Supportive medications such as antiseizure medications and pain relievers will be~          administered as appropriate.~        -  At the time of death, researchers will follow standard procedures for notifying next of~          kin and will collect brain tissue and tumor samples from the deceased.~        -  Following tissue collection, the deceased will be released for autopsy and funeral~          procedures.~   "
176731|NCT01251900|"~     Background:~      - BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast~     cancer and other cancers, and may be associated with types of breast cancer that are more~     difficult to treat and more likely to recur. New cancer treatments are being developed~     specifically to treat individuals who have these gene mutations. However, more information is~     needed about the prevalence of these mutations in minority populations, including~     Hispanic/Latino populations. To study these populations, researchers are interested in~     collecting genetic material (DNA) and medical history information from Hispanic/Latino women~     who have been diagnosed with breast cancer.~      Objectives:~      - To collect saliva samples and medical and family history information from Hispanic/Latino~     women with breast cancer.~      Eligibility:~      - Hispanic/Latino women at least 18 years of age who have been diagnosed with breast cancer.~      Design:~        -  Participants will complete a questionnaire with information about place of birth,~          languages spoken by parents and grandparents, and information about their breast cancer~          diagnosis.~        -  Participants will provide a saliva sample (2 to 3 tablespoons) for analysis.~        -  No treatment will be provided as part of this protocol.~   "
176732|NCT01251887|"~     Background:~      - Rates of obesity have increased dramatically in recent decades, and researchers are~     investigating how changes in diets and physical activity have contributed to this increase.~     To understand how weight might be controlled, it is important to learn what kinds of dietary~     changes can affect hunger and might lower body weight. Essential fatty acids, for instance,~     are an important part of a healthy diet, but researchers have not yet determined the ideal~     amount of essential fatty acids that people should eat. By studying how different diets~     affect body chemistry and hormone levels in women who are overweight or obese, researchers~     hope to be able to determine better diets or treatments to help people reach and maintain an~     optimum healthy weight.~      Objectives:~      - To examine how certain fats in the diet affect body metabolism, hormones, and weight~     regulation.~      Eligibility:~      - Healthy women between 18 and 50 years of age who are overweight or obese (body mass index~     between 25 and 35).~      Design:~        -  This study has an initial screening visit and three phases. All participants will be~          involved in the first two phases of the study, and some participants will be involved in~          the third phase.~        -  Participants will be screened with a physical examination and medical history, in~          addition to blood and urine tests and questionnaires about eating habits and other diet~          factors.~        -  Phase 1: Participants will have three visits to the National Institutes of Health over a~          4-week period. At the visits, participants will have blood and urine tests, complete~          questionnaires, and have other tests including brain and body imaging studies.~          Participants will then be assigned to one of three study diets.~        -  Phase 2: Participants will have a 12-week diet phase, with all foods supplied by the~          study researchers. Participants will keep a daily log of food and beverage intake, and~          will have three testing sessions with procedures similar to those performed in Phase 1.~        -  Phase 3: Participants assigned to a particular study diet (one-third of all~          participants) will be given the option of continuing the diet for an additional 36 weeks~          (9 months), with food consumption, monitoring, and testing procedures similar to those~          performed in Phase 2.~   "
176733|NCT01251874|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with carboplatin and to see how well they work in treating patients with human epidermal~     growth factor 2 (HER2)-negative breast cancer that has spread to other parts of the body.~     Carboplatin kills cancer cells by damaging the deoxyribonucleic acid (DNA) that lets the~     cancer cell survive and reproduce. The body has proteins that try to repair the damaged DNA.~     Veliparib may prevent these proteins from repairing the DNA so that carboplatin may be able~     to kill more tumor cells. Giving veliparib with carboplatin may kill more tumor cells than~     carboplatin alone.~   "
176734|NCT01251861|"~     This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206~     works in treating patients with previously treated prostate cancer. Androgens can cause the~     growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the~     amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. It is not yet known whether~     bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate~     cancer.~   "
176735|NCT01251848|"~     The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each~     other when coadministered.~   "
176736|NCT01251835|"~     This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of~     sitaxsentan given alone and with rifampin will also be assessed.~   "
176737|NCT01251822|"~     This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that~     of prucalopride in the treatment of chronic constipation in females. A total of 240 patients~     will be randomly allocated to treatment with one or the other agent. The study consists of a~     14-day run-in period, with treatment subsequently administered for 28 days on a daily basis.~     During the study, patients will fill in a stool diary, samples of faeces will be collected,~     and colonic transit time will be measured prior to therapy, and from days 22 to 28 of~     treatment. The proportion of patients with normalised bowel movements (three or more~     spontaneous movements) during the last week of the study (days 22 to 28 of treatment) will be~     compared between treatments.~   "
176738|NCT01251809|"~     This is an assessment of efficacy and safety of three different doses of pegylated~     recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults~     with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for~     determining specific asparaginase doses to yield various durations of L-asparagine (ASN)~     depletion which are required within different treatment phases of ALL therapy.~   "
176739|NCT01251796|"~     This is a phase I study to determine the safety, tolerability and recommended phase II dose~     of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor~     metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic~     profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib~     will also be determined as secondary endpoints.~   "
176740|NCT01251783|"~     Objectives: To evaluate the safety; efficacy; bone mineral metabolism & immunity changes of~     the use of Metlin & Metlos added to the Infant Formula Study Design: Randomized, double~     blind, clinical, controlled trial, in 600 full-term infants of 15 ± 7 days randomized to~     recive formula with probiotics + Metlin + Metlos; formula with probiotics + Metlin; Formula~     with probiotics + Metlos; formula only with probiotics or formula without probiotics and~     prebiotics; having a totally breast feed group as control.). Outcomes variables were~     frequency of stools; bowel intolerance manifestations (abdominal distension, flatulency,~     regurgitations, vomiting); report of dermatological problems like eczema; changes on the~     intestinal microbiota; lipids profile (cholesterol, triglycerides, lipoproteins associated to~     cholesterol); anthropomorphic profile and somatic growth ( weight gain, stature, arm mean~     circumference, skin folds); bone mineral metabolism (high-speed bone ultrasonography); and~     changes in the immunity (changes in the concentrations of salivary IgA and the frequency of~     respiratory events suggestive of infection)]. Statistical analysis was made with STATA Ver.~     11.0 for Mac. Safety and efficacy variables, were compared by Chi squared in the case of~     categorical variables or by ANOVA or Kruskall Wallis for the numeric variables. When~     convenient, a covariates adjustment was done by ANOVA or by multiple lineal regressions for~     continuous numerical outcomes or logistic regression for categoric outcomes. In all the~     hypothesis tests the p significant value of <0.05 were used.~   "
176741|NCT01251770|"~     The primary objective of this study is to compare the blood sodium level after 12 hours~     following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose~     5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.~   "
176742|NCT01251757|"~     The purpose of this randomized clinical trial is to determine whether two low-intensity,~     technology based interventions, when compared to each other and to usual care, improve~     adherence to selected medications that are used to treat people with cardiovascular disease~     (CVD) and diabetes.~   "
176743|NCT01251744|"~     This study is designed to evaluate maternal virological and immunological parameters to~     determine their ability to predict congenital cytomegalovirus (CMV) infection. When a~     pregnant woman is infected with CMV, her immune system (which protects her from infection) is~     activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine,~     vaginal secretions). The aim of this study is to find out if there is a link between either~     the pregnant woman's immune response or the presence of the virus in these bodily fluids and~     the child/foetus being infected with the virus.~   "
176744|NCT01251731|"~     The purpose of this study is to evaluate the single-dose (SD) pharmacokinetics (PK),~     pharmacodynamics (PD), safety and tolerability of 10, 40, and 80 mg E5501 followed by a~     selected dose for multiple dosing (MD) in healthy Japanese, Chinese, and Caucasian subjects.~   "
176745|NCT01251718|"~     To investigate the clinical safety and effectiveness of donepezil hydrochloride~     administration in patients with mild or moderate Alzheimer's Disease~   "
176746|NCT01251705|"~     Comparison of different methods for measuring peoples corneal thickness~   "
176747|NCT01251692|"~     To determine the ten-year visual results and outcome of excimer laser phototherapeutic~     keratectomy (PTK) for recurrent corneal erosions.~   "
176748|NCT01251679|"~     The purpose of this study is to determine whether nonpharmaceutical interventions (i.e.,~     handwashing and masks) reduce secondary transmission of influenza in households.~   "
176749|NCT01251666|"~     Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health~     priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while~     the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless~     automated quantitative I-FOBTs have not been compared, and the optimal number of samples and~     threshold is not yet fixed. The aim of this study is to compare the performances of the 2~     more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by~     Eiken) for different positivity thresholds and numbers of samples in general average risk~     population. Patients will performed a two samples Magstream, a two samples OC Sensor and~     Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and~     specificity for detection of cancer and advanced neoplasias will be compared between tests~     using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of~     samples and positivity threshold.~   "
176750|NCT01251653|"~     To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in~     combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors.~      To assess the safety of the combination. To investigate the PK characteristics of docetaxel~     or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess~     antitumor activity.~   "
176776|NCT01251302|"~     To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood~     assay changes the diagnostic testing pattern in patients referred to a cardiologist for the~     evaluation of chest pain or anginal equivalent symptoms.~   "
176751|NCT01251640|"~     Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus~     gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.~      Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine~     (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.~      Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints:~     response duration, disease control rate, time to progression, progression-free survival,~     overall survival, safety and tolerability.~      Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and~     weekly throughout the study; Safety follow-up visit 30 days after the last dose of study~     treatment; Survival follow up monthly for up to 8 month after LPFV.~   "
176752|NCT01251627|"~     The study aims to assess the activity of decitabine in the treatment of CMML.~   "
176753|NCT01251614|"~     This study will compare how well adalimumab works versus methotrexate (MTX) in children with~     moderate to severe psoriasis in the short term. It will also study how safe and how well~     adalimumab works in the long term and how long disease response can be maintained after~     stopping therapy.~   "
176754|NCT01251601|"~     The purpose of this study is to determine whether pregnancy affects the blood concentrations~     of raltegravir by comparing the second trimester and third trimester drug concentrations with~     post partum.~   "
176755|NCT01251588|"~     To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic~     microfracture, in participants who received study treatment in the SUMMIT study for treatment~     of symptomatic articular cartilage defects of the knee.~   "
176756|NCT01251575|"~     This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works~     in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor~     peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation~     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.~     It may also stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving total-body irradiation together with sirolimus, cyclosporine, and mycophenolate~     mofetil before and after transplant may stop this from happening.~   "
176757|NCT01251562|"~     The primary objective of this clinical study is as follows:~      • To determine the MTD and to assess the safety and tolerability of C31510 administered as a~     single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors~      The secondary objective of this study is as follows:~      • To evaluate plasma PK and estimate renal elimination of C31510 administered as a single~     4-hour IV infusion (up to nine different dosages) in subjects with solid tumors~      The exploratory objectives of this study are as follows:~        -  To evaluate the pharmacodynamic correlates of C31510 activity in plasma and peripheral~          blood cells~        -  To radiographically evaluate the effects of C31510 on tumors. In selected subjects, the~          effects on vascular permeability will be assessed by digital contrast enhanced~          (DCE)-magnetic resonance imaging (MRI)~        -  To evaluate tumor response (preliminary antitumor activity) after repeat administration~          of C31510~        -  Long-term safety and tolerability of C31510 after repeat administration~   "
176758|NCT01251549|"~     ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower~     limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be~     used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple~     sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.~   "
176759|NCT01251536|"~     The purposes of this study are to determine whether administering escalating doses of~     cetuximab in patients with no early skin toxicity could delay the progression of disease in a~     significant proportion of patients and to study the molecular signatures of response.~   "
176760|NCT01251523|"~     The proposed randomized clinical trial will compare two educational interventions: Physicians~     Asthma Care Education (PACE) and PACE Plus with 90 physicians in Atlanta and the Bronx and~     their 1192 patients.~   "
176761|NCT01251510|"~     PURPOSE~      The goal of the present project is to unravel the importance of bile acid-induced GLP-1~     secretion (via the G protein-coupled receptor TGR5) in human physiology.~      In the present study the investigators examine the GLP-1 secretion in healthy subjects and~     cholecystectomised patients. Thereby the investigators aim to show, that cholecystectomised~     patients have reduced bileflow after a meal, and as a consequence exhibit a diminished GLP-1~     response as compared to healthy subjects.~   "
176762|NCT01251497|"~     The purpose of the study is to evaluate the effectiveness of the íSi, Yo Puedo Controlar Mi~     Diabetes! (Yo Puedo) diabetes self-management education program.~   "
176763|NCT01251484|"~     VEGF inhibition by BEV may induce a change in tumor invasiveness and treatment failure is~     often associated with remote metastases. BEV may stop the growth of tumor cells by blocking~     blood flow to the tumor. Cediranib, a pan-VEGF inhibitor has shown promising results in~     recurrent GBM.~      VEGF-blocking with small molecules may overcome the mechanism of resistance, and response to~     BIBF-1120 in such circumstances may open a new treatment option in GBM. In additional,~     recurrent glioblastomas have an extremely poor prognosis, so innovative therapies are needed.~   "
176764|NCT01251471|"~     The aim of this pharmaco-MRI study is to investigate neural correlates of variable~     antidepressant treatment response driven by genetic variation in multiple genes involved in~     depression.~      Thirty Major Depressive Disorder (MDD) patients with a concurrent major depressive episode~     will undergo three MRI scanning sessions after escitalopram treatment initiation.~     Furthermore, extensive behavioral assessments and measures of potential peripheral markers~     such lymphocyte mRNA or pharmacological parameters on platelets or lymphocytes will be~     performed.~      Imaging measures have been suggested to be superior for drug response assessment as compared~     to psychometric scales, which hardly correlate with biological parameters. Since imaging~     techniques are too expensive and sophisticated for a broad clinical use, this study will~     provide pilot data on potential peripheral biomarkers of neural activation being related to~     drug response.~   "
176765|NCT01251458|"~     This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel~   "
176766|NCT01251432|"~     This research study measures how well the Eustachian tube works and looks directly at the~     anatomy of the Eustachian tube in adults who have had tympanostomy tubes surgically inserted~     into their eardrums because they have been diagnosed as having either otitis media or poor~     Eustachian tube function. The Eustachian tube is a biologic tube that connects the back of~     the nose to the middle ear (the airspace located behind your eardrum). That tube is usually~     closed, but can be opened by swallowing and other activities. Periodic openings of the~     Eustachian tube allow air to flow between the nose and middle ear which keeps the pressure of~     gas in the middle ear at the same level as that of the atmosphere, a condition required for~     good hearing. In children and adults, middle-ear diseases such as otitis media with effusion~     (the buildup of fluid within the middle ear) and a form of temporary hearing loss (conductive~     hearing loss) occur if the Eustachian tube does not open, does not open frequently enough or~     is always open (called a patulous Eustachian tube). A diagnosis of these different conditions~     can be made using standard, clinical tests of Eustachian tube function and the Eustachian~     tube can be visualized where it enters the back of the nose using a specialized telescope~     called an endoscope. Some scientific reports suggest that the cause of poor Eustachian tube~     function in an individual can be determined by studying the anatomy of the Eustachian tube at~     the back of the nose and the movements of the Eustachian tube in that area during swallowing,~     talking and other activities using an endoscope.~      In this study, the investigators plan to explore the relationship between the results of the~     standard Eustachian tube function tests and those for the anatomy and function of the~     Eustachian tube in adults with a disease condition likely to be caused by poor Eustachian~     tube function. Also, there are a number other disease conditions (examples: nasal allergy,~     acid reflux disease) that are related to poor Eustachian tube function and it is possible~     that these conditions and their effect on Eustachian tube function can be treated with~     medicines. Therefore, the investigators also plan to evaluate enrolled persons for those~     conditions. It is expected that if the results of the standard Eustachian tube function tests~     can be explained by the anatomy of the back of the nose and Eustachian tube, the functional~     anatomy (movements during swallowing etc) of the Eustachian tube or the presence of allergy~     and or/acid reflux disease, new medical and/or surgical treatments can be developed to~     improve Eustachian tube function and cure or treat the associated middle-ear diseases.~   "
176767|NCT01251419|"~     The goal of this project is to understand the effects of receiving peer information on~     individuals' conversion rates from brand name prescription medication to generic prescription~     medication.~   "
176768|NCT01251406|"~     The mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1~     (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged~     heart muscle cells to restore their structure and function. This study will investigate the~     safety and efficacy of rhNRG-1 to treat stable chronic heart failure.~   "
176769|NCT01251393|"~     Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15~     and 64 years old. The drug dependence has been described by many authors as a dysfunction of~     the brain reward system. Considering the effects of the cholinergic system on the drug reward~     and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine~     dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic~     antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To~     accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be~     study. This is a double-blind controlled and randomized placebo study. All the patients will~     be treated with brief intervention therapy (BIT), and half of them will receive biperiden~     (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated~     through the comparison between the values obtained on the following measures before and after~     the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and~     the presence of the cocaine metabolite (benzoylecgonine) on urine.~   "
176770|NCT01251380|"~     The purpose of this research study was to determine the long term safety and efficacy of~     repeated treatments with Dysport® used in the treatment of lower limb spasticity in children~     with dynamic equinus foot deformity due to cerebral palsy.~   "
176771|NCT01251367|"~     The purpose of this research study is to assess the long term safety of Dysport® in~     hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over~     repeated treatment cycles.~   "
176772|NCT01251354|"~     The purpose of the protocol is to determine the effect of BN83495 on the progression of~     endometrial cancer with estrogen receptor in post menopausal women who had previously~     received chemotherapy.~   "
176773|NCT01251341|"~     The increasingly widespread use of meditation for stress-related emotional and medical~     conditions highlights the urgent need to rigorously evaluate mechanisms through which the~     benefits of practice might be conferred. Primary challenges in this regard include evaluating~     dose response relationships between practice time and outcomes; clarifying whether~     physiological and behavioral effects of meditation derive primarily from non-specific aspects~     of training or result from specific meditation practices; and identifying molecular~     mechanisms by which meditation might affect physiological responses relevant to~     stress-related illness. Recent findings from a cross-sectional study by our group indicate~     that young adults who are randomized to, and practice, compassion meditation demonstrate~     reduced inflammatory responses, less emotional distress, and reduced autonomic responses to a~     standardized laboratory psychosocial stressor (Trier Social Stress Test [TSST]) when compared~     to subjects randomized to an active control condition. However, as a result of the~     cross-sectional study design and lack of a meditation comparator arm, these results provide~     only partial insight into key issues outlined above regarding the role played by specific~     meditation procedures and/or practice time in observed physiological and behavioral outcomes.~     The primary hypothesis of the proposed work is that practicing a meditation procedure~     specifically designed to enhance empathic concern for others (i.e. compassion meditation)~     will optimize autonomic reactivity to psychosocial stress in a manner that results in~     diminished activation of peripheral inflammatory signaling pathways and reduced behavioral~     distress.~   "
176774|NCT01251328|"~     Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are~     considered to be too sick for conventional aortic valve replacement. There is no conclusive~     opinion about the best anesthesiologic management of these patients. Sedation and general~     anaesthesia are both adequate and the current literature shows no benefit towards one of~     these methods.~      This study wants to investigate the influence of these two anesthesiologic managements on the~     cerebral oxygen saturation during the rapid pacing-period during valvuloplasty. The~     patients are randomised allocated to one of these two anaesthesiological managements. The~     investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen~     saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral~     hypoxia.~   "
176775|NCT01251315|"~     Glutathione is a powerful protective substance found within every cell in the body. It has~     been shown that glutathione levels go down as a person gets older, which makes a person more~     likely to get heart disease, high blood sugar problems and different kind of cancers.~     N-Acetyl Cysteine is used as a dietary supplement. It has been reported to increase~     glutathione levels in the body. The diet supplement called ProImmune is also changed by the~     body into glutathione. Therefore, the purpose of this study is to find out the effect of~     ProImmune in healthy people. This study will also help to prove whether or not the ProImmune~     is able to improve the blood levels of glutathione in healthy people.~   "
176778|NCT01251276|"~     The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years~     following completion of a primary series with a hepatitis B vaccine (Base Study V232-059,~     NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B~     vaccine.~   "
176779|NCT01251263|"~     This study will examine the combined effects of a continuous oral contraceptive (OC) regimen~     with supplemental estradiol therapy on headache severity and occurrence in subjects with~     documented Menstrually Associated Migraines (MAMs). The subjects enrolling in the study will~     have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal~     contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen~     following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs,~     the subject will institute a 4-day hormone-free interval (HFI). In an attempt to~     prevent/lessen the severity of headache during the HFI, subjects will be randomized to oral~     estradiol or placebo during this period. If no BTB/BTS occurs after 80 days of continuous~     pills, the subject will institute a 4-day HFI during which they will be randomized into~     estradiol or placebo groups.~      The purpose of this research study is to examine the effects of continuous oral contraceptive~     pills and oral estradiol on headaches that occur around the time of your period. Many woman~     take continuous oral contraceptive pills (OC) and when OCs are stopped they may get~     headaches. This study will examine if taking estradiol around the time of the period will~     affect the headache, and how it will be affected.~      This study is a prospective trial. A subject's participation will last approximately 32~     weeks.~   "
176780|NCT01251250|"~     RATIONALE: Azadirachta indica may be an effective treatment for chronic lymphocytic leukemia.~     PURPOSE: This phase I trial is studying the side effects and best dose of Azadirachta indica~     in treating patients with chronic lymphocytic leukemia.~   "
176781|NCT01251237|"~     It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy~     for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions~     are well established as safe and effective agents for gut cleansing and Norgine has~     successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and~     safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient~     acceptance.~      Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in~     subjects' compliance with gut preparation procedure. The study medication NRL0706 is~     identical to the PEG+E-containing gut lavage solution commonly used in clinical practice,~     with the exception that the flavour has been modified from lemon to orange. This study is to~     investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706~     (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for~     colon cancer screening.~   "
176782|NCT01251224|"~     The MAAIT is a randomized, controlled trial of a home intervention to reduce mouse allergen~     exposure in mouse allergic children with asthma and mouse allergen exposure. Participants~     will be randomized to either the Integrated Pest Management (IPM) Group or the Education~     Group. The IPM Group will receive professional mouse abatement, education, two HEPA filters,~     allergen-proof mattress and pillow encasements, and targeted cleaning. The Education Group~     will receive education about IPM at the beginning of the trial and then after completion of~     the trial, will receive the IPM intervention. Participants will be followed for 12 months.~   "
176783|NCT01251211|"~     Pain due to peripheral nerve lesion remains extremely difficult to treat and current~     treatments have onl moderate efficacy and/or side effects. The investigators have previously~     demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of~     patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to~     a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with~     peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its~     mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second~     injection is associated with a therapeutic gain. This will be a randomized placebo controlled~     study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous~     injection in the painful area) or placebo. Each injection will be repeated within at least 3~     months depending on the duration of efficacy. Skin punch biopsies will be performed before~     and 1 month after BTX-A administration. The investigators postulate that this study will~     confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the~     treatment of peripheral neuropathic pain.~   "
176784|NCT01251198|"~     Observatory multicenter, prospective, to support the acute phase of acute coronary syndromes~     with ST segment elevation ST (myocardial infarction).~   "
176785|NCT01251185|"~     Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves~     for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.~   "
176786|NCT01251172|"~     This phase II clinical trial is studying how well gamma-secretase/Notch signalling pathway~     inhibitor RO4929097 (RO4929097) after autologous stem cell transplant works in treating~     patients with multiple myeloma. Giving chemotherapy, such as melphalan, before autologous~     stem cell transplant stops the growth of cancer cells by stopping them from dividing or~     killing them. Before treatment, stem cells are collected from the patient's blood and stored.~     After chemotherapy, the stem cells are returned to the patient to replace the blood-forming~     cells that were destroyed by the chemotherapy. RO4929097 may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Giving RO4929097 after autologous~     stem cell transplant may kill more cancer cells.~   "
176787|NCT01251159|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This laboratory study is studying bone marrow samples from patients with acute~     myeloid leukemia.~   "
176788|NCT01251146|"~     This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the~     effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous~     system's (SNS) activity in subjects with essential hypertension.~   "
176789|NCT01251133|"~     This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study~     to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus~     toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same~     vaccination with primary one in healthy toddlers who completed the primary vaccination with~     LBVH0101 or Hiberix™ in LG-VHCL002 study.~   "
176790|NCT01251120|"~     This randomized, open-label, parallel-group study will assess the effect on disease remission~     of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs~     (DMARDs) versus current best practice non-biologic DMARD therapy in patients with~     moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the~     RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every~     4 weeks. The anticipated time on study treatment is 12 months.~   "
176791|NCT01251107|"~     The choice of a preferred first-line treatment requires balancing the desire for optimal~     disease control with the occurrence of early and late treatment-related effects. To fully~     assess this balance, the treatment decision process should ideally take into account the~     outcome following a consistent second-line therapy, in particular when tolerated, widely~     applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing~     initial chemotherapy.~   "
176792|NCT01251094|"~     Background~      Cognitive impairment in Parkinson's disease (PD) is common, even in the early stage of this~     disease.The cumulative prevalence of dementia associated with Parkinson's disease (PDD) is as~     high as 80% in a recent 8-year prospective study. However, some kinds of cognitive impairment~     are not apparent and the value of self-report cognitive decline became limited. In other~     words, some cognitive impairment may be detected by cognitive tests rather than self-report~     of the symptoms.The early intervention of the cognitive impairment may be helpful for these~     patients. Neuropsychiatric symptoms(NPSs) are also common in PD and PDD patients. The~     severity of NPSs contributes to reduced quality of life and distress for caregivers. Previous~     studies showed some different clinical phenotypes of NPSs in PD or PDD patients. Among the~     NPSs, hallucination was considered a critical factor of cognitive dysfunction in PD and PDD~     patients. The co-occurrence of NPSs in PD and PDD patients has limited evidence now.~      Purpose~      To establish the screening tools for early detecting the PD patient with cognitive~     impairment; exam the diagnostic value of MoCA and other cognitive tests in PD with mild~     cognitive impairment, possible PDD, and probable PDD; understand neuropsychiatric symptoms~     (NPSs) in these different patient groups; exam the relationship between each NPS and each~     domain of cognitive dysfunction.~      Methods~      In order to exam the cognitive dysfunction in PDD (attention, executive function,~     visuo-spatial function, and memory), several tests are performed. A 32-item cognitive decline~     questionnaire will be used to screen the cognitive impairment in subjects. Mini-Mental state~     examination (MMSE) and Montreal cognitive assessment (MoCA)are used for cognitive evaluation.~     The detail evaluation of each domain is specified asfollowing: (1) Attention (WAIS-R digit~     span), (2) Memory (12-item word recall test),(3) Executive function (category verbal~     fluency), (4) Visuospatial function (cube copying and clock drawing). The motor symptoms~     severity of the PD will be evaluated by the Hoehn & Yahr stage and motor portion of the~     Unified Parkinson's Disease Rating Scale (UPDRS). The neuropsychiatric symptoms will be~     recorded by Neuropsychiatric Inventory Questionnaire (NPI-Q). The daily living activity will~     beevaluated by modified Lawton's instrumental activities of daily living scale (IADL)and pill~     questionnaire. Subjects also receive 15-item Geriatric Depression Scale(GDS-S) to evaluate~     the mood status. The clinician's diagnosis of dementia will be based on the diagnostic~     criteria of DSM-IV, which will be compared with the PDDdiagnostic criteria proposed by MDS in~     2007. The investigators will also try to develop a PDDscreening questionnaire.~      Expected results~      Cognitive impairment and dementia of PD patients will be ascertained by the cognitive test~     battery. The screening questionnaire will be established. The heterogeneity of NPSs in PD and~     PDD will be evaluated. The PDD screening questionnaire will help the clinician to diagnose~     the patients.~   "
176793|NCT01251081|"~     In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from~     50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.~   "
176794|NCT01251068|"~     Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside~     investigation of cerebral oxygenation in newborn infants. Using this technique we~     investigated the relationship between changes in cerebral oxygenation and hemodynamics, and~     changes in some physiological variables during blood transfusion in anaemic preterm infants.~   "
176795|NCT01251055|"~     The etiology of schizophrenia remains unclear In recent one decade, hypofunction of~     N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of~     schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for~     schizophrenia treatment.~      To date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult~     clinical issue. However, the effect of NMDA treatment in refractory schizophrenia is still~     unknown. Therefore, the primary goal of this study is to investigate the efficacy and safety~     of NMDA adjuvant therapy in refractory schizophrenia, and to identify the predictors for~     treatment response to NMDA enhancers.~   "
176796|NCT01251042|"~     The study is an open, randomized, controlled, single-centre study including a total of 42~     evaluable subjects scheduled for spinal surgery with an approximate expected bleeding of~     800-1500 ml. The Sangvia® Blood Salvage System will be set up for all subjects to collect~     blood intra-operatively. When the transfusion bag is filled, i.e. when around 500 ml of blood~     has been collected, the subject will be randomized to either be retransfused with the blood~     collected (investigational group) or not (control group). The primary objective for this~     study is to investigate the blood quality and isolate the systemic effects in~     intra-operatively collected blood. The systemic p-Hb concentration has been chosen as the~     primary outcome variable based on previous experience and literature and is considered as the~     major safety concern for the study subjects.~   "
176797|NCT01251029|"~     Acute kidney injury (AKI) is one of the most serious and frequent complication of general~     anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI. CKD~     patients often need some surgical interventions that have been done under general anesthesia;~     they therefore have an increased probability to develop AKI.~      N-acetylcysteine (NAC), a thiol compound with antioxidant and vasodilatory properties,~     reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury~     and the levels of pro-inflammatory cytokines. NAC has been reported to protect the kidney~     from injury induced by contrast media, ischemia, and toxins.~      Present study aimed to explore the efficacy of NAC treatment to prevent deterioration in~     renal functioning in CKD patients undergoing major surgery under general anesthesia.~      Study will include about 200 CKD (eGFR (estimated glomerular filtration rate) less than 40)~     patients that should undergo surgical interventions under general anesthesia and will divide~     to 3 groups as follows: group 1- about 40 patients which should undergo major vascular~     surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery~     (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major~     abdominal surgery. Patients from each group will randomly divide in two sub-groups (A and B).~     Subgroup A will receive NAC twice (14-16h and 2h) before surgery and 12h after surgery.~     Subgroup B will receive placebo (saline).~      Markers for kidney function such as eGFR, creatinin, urea, electrolytes, cystatin C, NGAL~     (Neutrophil Gelatinase-Associated Lipocalin), urine albumin will measure before and after~     surgery in all patients. An additional blood samples for assessment of nitric oxide and~     cytokine levels will be taken from each patient before and after surgery.~   "
176798|NCT01251016|"~     Type 2 diabetes mellitus (T2DM) is a relevant public health problem and obesity has been~     associated as the major risk factor. Roux-en-Y gastric bypass is an effective method to treat~     severe obesity, and its metabolic benefits can lead to early and complete remission of T2DM,~     even before a considerable weight loss. We have hypothesized that intestinal anatomic changes~     may change intestinal genes expression related to glycemic control. The knowledge of~     mechanisms mediating the glycemic control after Roux-en-Y gastric bypass and it site of~     action in bowel may eventually help to develop alternative, less invasive and safer surgery~     for the treatment of T2DM, as well as drug development for the newly targets identified.~   "
176799|NCT01251003|"~     The purpose of this study is to determine if it is safe to use stored autologous Human~     Umbilical Cord Blood (hUCB) to treat pediatric patients that sustain a severe or moderate~     Traumatic Brain Injury (TBI), and have not fully recovered as measured by the Glasgow Outcome~     Score-Expanded (GOS-EC)/Child at 6 to 18 months post-injury.~   "
176800|NCT01250990|"~     This study looks at whether niacin improves reverse cholesterol transport (RCT) in healthy~     volunteers. 3H-Cholesterol will be used to measure RCT by analyzing changes in the tracer~     activity in total plasma, lipoproteins, red blood cells (RBCs) and stool. The hypothesis is~     that niacin augments reverse cholesterol transport.~   "
176801|NCT01250977|"~     The objective of this proof-of-concept pilot study is to evaluate Donepezil HCL (Aricept),~     for adherence, side effects and effects on smoking behavior in a population of dependent~     smokers.~   "
176802|NCT01250964|"~     The purpose of this study is to determine if there is any difference in astigmatism (eye~     surface curvature) or corneal endothelial cell density (the inner cell lining of the eye~     surface) after two different methods for inserting a lens during cataract surgery.~   "
176803|NCT01250951|"~     This study will evaluate the efficacy and safety of deferasirox in patients with MDS,~     thalassemia and rare anemia patients with transfusion iron overload.~   "
176804|NCT01250938|"~     The purpose of this study is to test the applicability of a caregiver-implemented autism~     intervention protocol to a deliberately recruited low-income, underserved population.~   "
176805|NCT01250925|"~     The purpose of this study is to utilize in-vivo confocal microscopy to describe differences~     in corneal epithelial immune status across three lens care regimens in new contact lens~     wearers.~   "
176806|NCT01250912|"~     Some patients are at risk for life-threatening fast heart rates. These can frequently be~     treated by using a catheter inside the heart to burn away the cells that create the fast~     heart rates. The purpose of this study is to image the nerves inside the heart of those~     patients. The investigators want to find out if abnormalities in the nervous system in the~     heart can help the physician to find the area that needs to be burnt away.~   "
176807|NCT01250899|"~     This is a research study to look at vitamin D deficiency (low levels) in men and women with~     HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If~     your levels are low, and you choose to start using vitamin D supplements, the investigators~     would like to take some blood before and after you start using vitamin D to see how this~     affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators~     will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study.~     If you and your physician decide that you should continue taking vitamin D supplements after~     that time, you will be responsible for purchasing your own vitamin D supplements.~   "
176808|NCT01250886|"~     The purpose of this study is to determine whether fluid administration in patients undergoing~     colonoscopy should affect acid-base disorder in term of the strong ion differences.~   "
176809|NCT01250873|"~     LY2216684 is being studied as adjunctive treatment for MDD in patients who are partial~     responders to SSRIs. Sertraline is a medication that is widely used to treat MDD and it is a~     known substrate of CYP450s, including CYP2D6, CYP2C19 and CYP3A4, and a modest inhibitor of~     CYP2D6. Based on the diversity of hepatic metabolic clearance pathways for LY2216684 and its~     elimination by the kidney, it is expected that CYP2D6 inhibition by sertraline will not~     result in a substantial change in the PK profile of LY2216684. LY2216684 is only known to be~     a moderate inhibitor of CYP2C19 so it is unlikely that coadministration of sertraline with~     LY2216684 will result in a clinically meaningful change in the PK of sertraline. This study~     is being conducted to test these hypotheses.~   "
176810|NCT01250860|"~     The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on the~     function of the respiratory system and the morphology of the ribcage in short-term intensive~     physiotherapy.~   "
176811|NCT01250847|"~     The primary objective of this study is to assess the effects of 'Seroquel-XR' on the verbal~     learning ability in people with at-risk mental state (ARMS) over a 12 week period. The verbal~     learning ability will be indexed by delayed free recall score of CVLT(California Verbal~     learning Test), a standard neuropsychological verbal memory tests.~      The secondary objective is to assess the effects of 'Seroquel-XR' on other cognitive function~     and psychiatric symptoms including psychotic, anhedonic symptoms, and impulsivity. The~     cognitive function abilities will be measured by standard neuropsychological tests as~     follows;~        -  Working memory: verbal & spatial 2-back test~        -  Attention: Digit Span, 3-7 CPT(Continuous Performance Test)~        -  Executive function: WCST (Wisconsin Card Sorting Test)~        -  Visuo-spatial ability: Rey Complex Figure Task copy~        -  Visuomotor speed and planning: Trail making test A & B~        -  Verbal fluency: Controlled Oral Word Association Test(COWAT) The scales of psychiatric~          symptoms which will be used are as follows;~        -  Psychotic symptoms: Scales of Prodromal scales (SOPS), Positive and negative syndrome~          scale (PANSS)~        -  Anhedonia: Social Anhedonia Scale (SAS), Physical Anhedonia Scale (PAS)~        -  Social cognition: Ambiguous Intention Hostility Questionnaire (AIHQ)~        -  Impulsivity: Barrett Impulsivity Scale (BIS)~   "
176812|NCT01250834|"~     This study will assess if giving LY2189265 at the same time as atorvastatin affects how the~     body absorbs atorvastatin.~   "
176813|NCT01250821|"~     Ovulation disorders are a common cause of infertility in women. Most of these women can be~     classified as World Health Organization (WHO) Group II anovulatory patients as they have~     irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation~     hormone (FSH) and estradiol.~      The purpose of this study is to optimize the low-dose-step-up protocol traditionally used for~     ovulation induction with follicle-stimulating hormone (FSH) in women with anovulatory~     infertility WHO Group II.~      Previous studies have established that menstrual cycle history, mean ovarian volume and BMI~     are significant predictors of FSH threshold dose in women with anovulatory infertility WHO~     Group II undergoing ovulation induction (Nyboe Andersen et al., 2008). A FSH dosage nomogram~     has been constructed based on these variables.~      The aim of this study is to evaluate the clinical use of the nomogram in order to test the~     use of the variables to determine whether an individualized starting dose of FSH can be used~     for ovulation induction in anovulatory patients.~      It is the hypothesis that an individualized starting dose of gonadotrophin will minimize the~     disadvantages of the treatment and that the stimulation period of the individualized~     nomogram-based treatment will be 25% shorter than observed in the standard protocol.~      The primary endpoint is the proportion of patients who reach the criteria for~     hCG-administration within 14 days of Menopur stimulation. The results of the study will be~     compared with the data obtained in the Menopur Ovulation Induction Trial (Platteau et al.,~     2006).~   "
176814|NCT01250808|"~     Multiple Myeloma (MM) is the second diagnosed malignancy of hematological malignancies. The~     previous study pointed out that the dosage and course of Bortezomib including the dose of~     concomitant drugs used to treatment MM patients did not get the preferred treatment program,~     so we are going to determine the optimal doses and course of Bortezomib through the~     prospective, multicenter clinical trial and evaluate the efficiency and safety of different~     program.~   "
176815|NCT01250795|"~     The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1~     Vaccine in healthy adults.~   "
176816|NCT01250782|"~     Recent reports suggest that most beneficial results of glutamine have been obtained with the~     parenteral administration of high doses of glutamine (0.35 g/Kg/d) and in some special group~     of patients, such as traumatic patients. Nevertheless total parenteral nutrition is not often~     used in critically ill patients.~      The endovenous administration of the the dipeptide N(2)-L-alanyl-L-glutamine in trauma ICU~     patients can reduce the number of infections, ICU length of stay and mortality.~      This benefit can be achieved independently the type of nutrition (enteral or parenteral~     nutrition), being a pharmaconutrient.~   "
176817|NCT01250769|"~     This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning~     modalities on oral health.~   "
176818|NCT01250756|"~     Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group~     1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular~     pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up~     doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to~     demonstrate that the immune responses as measured by serum antibody responses to diphtheria~     toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by~     DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP~     given alone. In addition, the study aims to evaluate the side effects (safety profile) after~     vaccination of 7vPnC when given with DTaP in healthy Japanese infants.~   "
176819|NCT01250743|"~     The purpose of this pilot study is to learn whether high doses of ascorbic acid (vitamin c),~     given intravenously to patients with chronic hepatitis due to infection with the genotype 1~     version of the hepatitis C virus, are safe, well-tolerated and able to reduce the amount of~     virus circulating in the patients' blood.~   "
176820|NCT01250730|"~     The purpose of this study is to investigate the pharmacokinetics of single doses of~     PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male~     volunteers.~   "
176821|NCT01250717|"~     The purpose of this research study is to determine if the combination of chemotherapy and~     hormone therapy is safe and helpful for patients who plan to have their high-risk prostate~     cancer surgically removed. Some physicians believe that patients with high risk cancer that~     is located in one area, may have an early but small spread of the cancer outside of the~     prostate, and perhaps even to distant organs. Therefore, better treatments for the entire~     body are needed to improve the ability of surgery or other local therapies to cure prostate~     cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced~     prostate cancer patients, it is possible that using chemotherapy combined with hormonal~     therapy earlier in the course of localized but high risk patients might improve the outcomes~     for these patients.~   "
176822|NCT01250704|"~     Neuromyotonia (NMT), so called Isaac's syndrome, is a rare disorder in which~     hyperexcitability of peripheral motor nerves leads to intermittent muscle contractions. It is~     characterized by muscle twitching at rest (visible myokymia), cramps, hyperhidrosis,~     paraesthesiae, mild muscle weakness. and impaired muscle relaxation, or pseudomyotonia.~     Electromyographic recording is a key diagnostic tool in detecting myokymia and neuromyotonia.~     Pathophysiology of neuromyotonia is claimed to be related immune disorder, autoimmune~     anti-voltage-gated potassium-channel antibodies and genetic mutation in potassium channel.~     KCNA1 (Kv1.1) mutation was mostly reported in a autosomal dominant trait. In the present~     study, we report a family affected with myokymia，worsening with elevated body temperature,~     febrile illness or spicy food. How the change in temperature influence clinical features of~     channelopathies is an interesting topic. Variant clinical severity of family members are~     recorded. The index patient has possible autoimmune mechanism involvement because of his~     clinical feature of myasthenia gravis with thymoma and hyperthyroidism. Further analyzing the~     genetic mutation in potassium channelopathy may provide researchers some pathophysiological~     insight into the Isaac's syndrome.~   "
176823|NCT01250691|"~     This study will carry out in the ICU. Objectives of the study are to determine the frequency~     of HAP and the effect of isolated rooms on the frequency of pneumonia in the ICU.~   "
176824|NCT01250678|"~     Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our~     knowledge about long term development of cognitive performance under natalizumab therapy is~     limited. We want to demonstrate with this study that patients treated with ntz improve in~     neurocognitive tests over the long term.~   "
176825|NCT01250665|"~     This study is a cross sectional study of patients diagnosed with clinically isolated syndrome~     (CIS) and RRMS, who will undergo a series of tests to assess cognitive impairment, fatigue~     severity and depressive symptoms. Cognitive impairment will be assessed with Multiple~     Sclerosis Inventory Cognition (MUSIC) and symbol digit modalities test (SDMT), fatigue~     severity will be measured with the Fatigue Scale for Motor and Cognitive Functions (FSMC) and~     depressive symptoms with the Beck Depression Inventory (BDI). All tests mentioned above are~     validated for MS patients. In the second step we will use our large longitudinal database of~     serial MRI examinations from which a linear measurement of CCI will be retrospectively~     calculated.~   "
176836|NCT01250509|"~     The purpose of this study is to determine whether a mindfulness-based stress reduction and~     mindful eating program will lead to reductions in abdominal fat and total weight and improve~     cell aging in overweight and obese women compared to a waitlist control group.~   "
176837|NCT01250496|"~     The routine administration of 75 mg of intravenous aminophylline following regadenoson~     (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce~     the gastrointestinal (diarrhea and stomach upset) and other side effects related to~     regadenoson.~   "
177276|NCT01244711|"~     The hypothesis of this study is that symptoms of anxiety, depression and insomnia; and~     indices of psychosocial function will all improve, while BZ use will decrease significantly~     during a twelve-week trial period of substituting quetiapine for benzodiazepines.~   "
176826|NCT01250652|"~     Allen Kaplan is a prominent American allergist with the reputation of leader in the field of~     chronic urticaria. He advocates treatment with first generation hydroxyzine, which he~     considers at least as effective as modern second generation H1-blockers in suppressing the~     symptoms of difficult-to-treat / systemic-steroid-dependant cases of chronic urticaria. He~     further speculates that hydroxyzine may have the advantage to better suppress itch and~     improve nighttime sleep. This has prompted many practitioners around the world to believe~     that adding hydroxyzine to the treatment regimen at bed time at night may be beneficial to~     patients. At the same time European guidelines indicate modern second generation H1-blockers~     in higher than conventional doses as drugs of choice for such cases. However, there is no~     evidence from clinical trials addressing this controversy. The investigators' previous~     studies suggest that levocetirizine at quadruple doses may be beneficial in difficult to~     treat urticaria by reducing lesions and itch, improving quality of life and night time sleep,~     while not causing day time somnolence. First generation H1-receptor antagonists and~     hydroxyzine among them are known to penetrate the blood / brain barrier and to cause~     sedation. The question stays whether this sedation is beneficial to the subjects with chronic~     urticaria at night, whether it has any hang-over unwanted effects the following day and~     whether this has any influence on the overall urticaria-specific quality of life.~   "
176827|NCT01250639|"~     This study is a cooperative project and aims to identify genetic components associated with~     type 2 diabetes mellitus (T2DM), which is significant for the population of non-aboriginal~     Taiwanese.~   "
176828|NCT01250626|"~     Inulin's usefulness as a diagnostic agent is based on the method of its elimination from the~     body. Inulin is biologically inert, unbound by plasma proteins, freely filtered at the~     glomerulus, and is neither reabsorbed, metabolized nor secreted by the kidneys. It is~     excreted almost entirely by glomerular filtration. Inulin clearance is considered to be~     identical to glomerular filtration rate (GFR).~   "
176829|NCT01250613|"~     Genomic aberrations in patients diagnosed as congenital malformation with unknown etiology~     will be identified using high-density oligonucleotide array.~   "
176830|NCT01250600|"~     Although a lot of evidence and guidelines recommend that patients have cardiac~     rehabilitation, in reality, the actual rate cardiac patients entering cardiac rehabilitation~     program is low, usually less than one third. One of the main hindrances of patients~     participating cardiac rehabilitation program is insufficient number of medical institutions~     that can provide rehabilitation services. Patients usually cannot perform exercise program~     under medical professionals monitoring without having to go far. This spatial and temporal~     difficulty led to the low rate of patients taking cardiac rehabilitation program. The risk of~     patients to do exercise is higher than healthy adult.~      This project will develop the intelligent portable remote care system for cardiopulmonary~     exercise to provide an instant ECG monitoring service through the integration of front-end~     wireless ECG measuring devices, expert system, and back-end tele-care platform. Many patients~     are inconvenient to go to large hospital regularly for cardiac rehabilitation training. This~     project will help them to exercise at home after once or twice rehabilitation training in~     clinic for each month and the medical professional will supervise remotely to see how much~     exercise they did. For that reason the project can help to break through spatial and temporal~     difficulty of having cardiac rehabilitation, so that cardiac rehabilitation can be help more~     patients. Patients have this tele-care system while they are doing exercise at home, the~     built-in heart rate and cardiac rhythm warning function will remind them to take a break,~     even to take medical treatment. More importantly, the ECG signal can be almost immediately~     (real time) uploaded by network to the chest pain unit of hospital. The cardiology expert~     will be aware of the warning at the first moment. This is an important protection to~     patients' safety of doing rehabilitation sports at home.~      This randomized control trial will recruit 80 patients who had myocardial infarction within 6~     weeks, and are not able to attend a hospital based cardiac rehabilitation program regularly.~     All patient will undergo a three-month home exercise program under the instruction provided~     by the physiatrists and physiotherapists. Forty of them (the remote-care group) will use the~     intelligent portable remote care system for cardiopulmonary exercise to monitor their~     exercise intensity and cardiac rhythm during exercise. The other 40 patients (the control~     group) undertake the exercise program at home without using the remote care system. The~     efficacy and safety of exercise program will be compared between the two groups.~   "
176831|NCT01250587|"~     The purpose of this study is to determine a safe and effective dose range for intravenous~     administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in~     patients with primary dysmenorrhea.~   "
176832|NCT01250574|"~     Postoperative complications, especially bacterial infections, are relatively common and cause~     increased morbidity and mortality. Effective and timely antimicrobial treatment is important~     for prognosis, and delayed diagnosis and treatment substantially increase mortality. The~     early diagnosis of infection and sepsis are today based on diagnostic tests that have been~     available for years, like WBC count, SR and CRP. These markers suffer from several drawbacks;~     their sensitivity and specificity for infection and sepsis are not good enough and their~     kinetics are rather slow in terms of both increase and decrease. A major disadvantage of CRP~     is that after surgery and trauma this marker generally increases for several days, reaching a~     plateau typically on day 2-4 following the event, and therefore, in most cases do not offer~     the needed guidance for early treatment of bacterial infection. More recently, other~     biomarkers for infection and sepsis have become available, some of which appear acceptable~     for diagnostic use. Procalcitonin (PCT) and neutrophil CD64 are both promising new markers~     for the early detection of infection. They do both have their pros and cons compared to each~     other and compared to the traditional markers, such as CRP and WBC count. It is a general~     view that further research is needed before these markers will be accepted as part of the~     routine protocol for the diagnosis of infections, especially in relation to postoperative~     complications. The aim of the present study is to investigate the clinical utility of~     procalcitonin (PCT) and neutrophil CD64 as markers for infection and inflammation:~        -  to evaluate if it is possible to detect early phase postoperative infections by using~          these tests versus traditional markers such as CRP, SR and WBC count (with~          differential).~        -  to differentiate between systemic bacterial infection and systemic inflammation due to~          the surgical trauma.~      The hypothesis is that PCT and neutrophil CD64 are more sensitive and specific analysis for~     the early detection of infection after abdominal surgery than CRP (and other widely used~     tests for inflammation and infection), and that neutrophil CD64 is more specific than PCT.~     Patients admitted to the Department of Gastroenterological Surgery, Akershus University~     Hospital for elective abdominal surgery will be included in the study after informed consent.~     Initially consecutive series of 150 patients will be included, but this number may be~     increased depending on the number of observed infections during the course of the study. All~     patients will be monitored and treated by the formal protocol related to clinical signs of~     infection, such as abcess, peritonitis, pneumonia, sepsis and septic shock. In addition to~     the analytical parameters routinely used today in order to discover infections (CRP, WBC~     count etc), blood samples for PCT and neutrophil CD64 will be analyzed before surgery and~     daily during the stay at the hospital. In the case of signs of infection, locally or~     systemic, the frequencies of analysing PCT and CD64 will be increased according to the~     severity of the changes in the clinical condition. The expression of CD64 will be measured by~     flow-cytometry and PCT will be measured by an immunochemical method.~   "
176833|NCT01250561|"~     The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute~     herpes zoster patients will decrease the incidence of post-herpetic neuralgia.~   "
176834|NCT01250548|"~     The purpose of this study is to compare the effects of apremilast with a placebo (an inactive~     substance that looks like apremilast) on you and other people with rheumatoid arthritis.~      The investigators will be collecting information in this study to help us determine -~        -  the safety of apremilast in patients with active rheumatoid arthritis~        -  how long it takes for patients with active rheumatoid arthritis to respond to apremilast~        -  how long the effects of apremilast last after the treatment has ended.~   "
176835|NCT01250535|"~     Drug-drug interactions play an important role in clinical adverse events due to the~     prevalence of multi-drug therapy. Co-administration of warfarin and a statin has expanded~     substantially in the US over the last decades. The purpose of this study is to develop a~     mechanistic understanding of the role of a drug-metabolizing enzyme, CYP4F2, in the~     interaction between warfarin and statins. This study will test the hypothesis that lovastatin~     potentiates the anticoagulant effect of warfarin by inducing vitamin K-metabolizing enzyme~     CYP4F2 in humans, thus increasing warfarin's anticoagulant effect.~   "
176838|NCT01250483|"~     The correlation between the change of serum prostate-specific antigen (PSA) or PSA velocity~     (PSAV) and severity of lower urinary tract symptoms (LUTS) has been poorly understood.~     Previous studies usually focused on the treatment efficacy or preventive role of alpha~     blockers (AB) for clinical progression of benign prostatic hyperplasia (BPH) and AB therapy~     in real-life practice improved BPH/LUTS and reduced the risk of overall clinical progression.~     We hypothesized that the change of PSA and PSA velocity would be correlated to LUTS severity~     in the groups of BPH and prostate cancer.~   "
176839|NCT01250470|"~     This phase I trial studies the side effects of vaccine therapy when given together with~     sargramostim in treating patients with malignant glioma. Vaccines made from survivin peptide~     may help the body build an effective immune response to kill tumor cells. Colony-stimulating~     factors, such as sargramostim, may increase the number of white blood cells and platelets~     found in bone marrow or peripheral blood. Giving vaccine therapy and sargramostim may be a~     better treatment for malignant glioma.~   "
176840|NCT01250457|"~     The purpose of this research is to find out if the use of topical timolol 0.5% solution~     applied twice daily will help to shrink rosacea lesions around the eye.~   "
176841|NCT01250444|"~     The purpose of this study is to determine inspiratory muscle training effects on blood~     pressure, functional capacity and quality of life in hypertensive patients.~   "
176842|NCT01250431|"~     The purpose of the study is to measure the change in psychological symptoms and gene~     expression in war veterans after a series of 10 EFT coaching sessions. Outcome studies have~     shown statistically significant reductions in depression, anxiety, and PTSD in veterans after~     EFT, and this study extends earlier research using biological sampling. EFT is a form of~     Energy Psychology (EP) that is sometimes referred to as emotional acupuncture. It involves~     self-stimulation of 14 acupuncture points at the end of meridians with the fingertips, while~     recalling an emotional event such as a combat trauma. It is typically effective in 6 to 15~     coaching sessions, making it an efficient clinical technique for reducing affect.~   "
176843|NCT01250418|"~     The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS~     Monitor during sedation with ketamine?~      The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence~     of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the~     use of ketamine.~   "
176844|NCT01250405|"~     The primary objective is to determine whether reduction of serum calcium concentration by~     cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary~     objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV),~     2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.~   "
176845|NCT01250392|"~     The goal of this project is to see if behavioral nudges will increase an individual's~     likelihood of participating in a nurse visit. The behavioral nudges under consideration are~     encouraging subjects to make an active choice and sending reminders.~   "
176846|NCT01250379|"~     This randomized, open-label, parallel-group study will assess the efficacy and s afety of~     Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second-~     and third-line therapy in patients with locally recurrent o r metastatic breast cancer~     progressing after first-line therapy with Avastin and chemotherapy. Patients will be~     randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks~     intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study~     treatment is until third-line disease progression or unacceptable toxicity occurs.~   "
176847|NCT01250366|"~     The purpose of this study is to determine the Safety and Pharmacokinetics of Multiple~     Ascending Oral Doses of INX-08189 in Chronically-infected Genotype 1 HCV, Treatment-naïve~     Subjects.~   "
176848|NCT01250353|"~     The main problem of ocular surface reconstruction is the lack of viable conjunctival tissue.~     The use of a biocompatible latex biomembrane in ocular surface healing, like post pterygium~     surgery, could be an alternative therapeutic resource to this process.~   "
176849|NCT01250340|"~     In individuals with Type 2 Diabetes (T2D) it has been obtained an outstanding improvement in~     the management of hyperglycemia, but it has not been achieved a similar result in the~     reduction of the atherosclerotic syndrome. The comprehension of the mechanisms that link over~     nutrition to inflammation and innate immune response can be important to understand the~     relationship between insulin resistance, diabetes mellitus and endothelial dysfunction. It~     will be investigated: 1) the role of Toll Like Receptors (TLR)s in the pathophysiology of T2D~     and associated atherosclerosis; 2) the role of aspirin and nicotinamide adenine dinucleotide~     phosphate (NADPH) oxidase inhibitor/s in the production of TxA2 and F2-isoprostanes in T2D~     patients; 3)new biomarkers associated to Diabetes and atherosclerosis including markers of~     endothelial dysfunction and cytokines.~      It will be analyzed in isolated platelets from normal controls and/or diabetic patients the~     production of TxA2, isoprostanes and pro-inflammatory/thrombotic cytokines using aspirin and~     NADPHoxidase inhibitors.~   "
176850|NCT01250327|"~     This prospective interventional study is designed to evaluate the cost/advantage ratio in the~     treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary~     valved stent (Melody).~   "
176861|NCT01250184|"~     Background: Myofascial pain syndrome (MPS) of the shoulder girdle and cervical region is a~     common musculoskeletal problem that is often chronic or recurrent. It has demonstrated the~     effectiveness of different treatments such as exercise, injection but not comparing them with~     each other. The objective of this research was to demonstrate whether lidocaine injection~     into trigger points combined with a physical therapy program was more effective than each~     separatetreatment in improving pain, function and quality of life in a group of patients with~     myofascial pain syndrome (MPS) of the shoulder girdle and cervical region.~      Design: Single-blind, randomized, controlled clinical trial with three parallel groups in the~     departments of physical medicine and rehabilitation of two urban hospitals. There were 127~     patients with myofascial pain in the shoulder girdle for more than six weeks in length and~     pain greater than 40 mm on the visual analog scale (VAS). There were three intervention~     groups: physical therapy (PT), lidocaine injection (LI), or the combination of both (PT +~     LI). The primary outcome at one month was the VAS, and the secondary outcomes were measured~     using the SF36 pain scaleat one and three months.~      Keywords: Myofascial pain, trigger points, lidocaine injection, physical therapy.~   "
176851|NCT01250314|"~     Rational: Osteoporosis in men is responsible for one third of fragility fractures. However~     the definition and especially the determinants of fracture in humans are less well known than~     in women.~      Primary Objective: To search radiologic, biochemical, genetic and micro-architecture bone~     factors associated to fractures in men with low bone density.~      Study design: case/control study (fracture vs. no fracture) with men selected according to~     low bone density (Z-score<-2).~      Eligibility criteria: Included subjects will be men whose age is ³ 40 and £ 70 years with a~     Z-score< -2 at least at one of the 3 measured sites (wrist, lumbar spine, femoral neck).~     Subjects with secondary osteoporosis will be excluded (corticosteroid treatment,~     hypogonadism, …) Progress of the study: The recruitment will be over two years. The study~     will include two periods, an inclusion visit and a period of 3 months to achieve radiological~     and biological examinations. The subjects will be recruited in the 3 rheumatology departments~     (LARIBOISIERE, COCHIN). Subjects will be investigated at LARIBOISIERE hospital to perform~     radiological examinations and biological sampling for laboratory tests within 3 months of~     enrollment.~      Evaluation criteria: Biochemistry: dosages of sexual steroids, bone remodeling markers and~     homocysteine; Genetic: evaluation of polymorphism of candidates genes associated to fragility~     fractures (collagen type I, homocysteine, LRP5); Radiology: evaluation of bone~     micro-architecture with a scan of lumbar spine and hip and peripheral micro-scan (XTREME~     sSCANCO) and bone densitometry at spine, femoral neck and wrist.~      Duration of participation: there is no follow up Total duration of the study: 2 years and 3~     months. Number of subjects: 100 patients with fracture and 100 controls without fracture~   "
176852|NCT01250301|"~     The aim of this study is to determine if using a behavioural replacement for smoking~     (de-nicotinised cigarettes; DNCs), in addition to standard treatment during the first two~     weeks after the target quit date, can reduce urges to smoke over the first 4-weeks of~     abstinence. Two hundred smokers who want to quit will be recruited from the community. They~     would all receive standard smoking cessation treatment from the NHS Stop Smoking Service (NHS~     SSS), which uses a combination of stop smoking medication (e.g. nicotine replacement therapy,~     Champix) and motivational support. On their target quit date, participants would be~     randomised to receive behavioural replacement ( i.e. use of de-nicotinised cigarettes) plus~     standard treatment for the first two weeks of their quit attempt, or to continue with~     standard treatment alone. De-nicotinised cigarettes are similar to standard cigarettes except~     that they do not deliver nicotine to the smoker. Participants will rate their urges to smoke~     at each week. Standard NHS SSS measures will also be taken in addition to user acceptability~     ratings and reactions to smoking cues.~      The hypothesis is that complementing current NHS SSS treatments with de-nicotinised~     cigarettes, to address the non-nicotine factors associated with smoking and to help~     extinguish smoking behaviour, would result in lower urges to smoke than standard treatment~     alone.~   "
176853|NCT01250288|"~     The purpose of this research study is to describe the usage of consumers and providers when~     using a novel technology designed to give consumers the ability to manage and access their~     health information. This is a quantitative descriptive analysis study.~   "
176854|NCT01250275|"~     The fatty acid composition of canola oil will have beneficial acute and chronic effects on~     vascular function in individuals with peripheral arterial disease.~   "
176855|NCT01250262|"~     The purpose of this study is to determine if a 4 month resistance exercise program reduces~     the severity of low back pain, pain-related fear avoidance and improves mobility compared to~     standard care.~   "
176856|NCT01250249|"~     To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited~     India with BCG vaccine of serum institute of India limited (SIIL), India in 120 healthy~     children.~   "
176857|NCT01250236|"~     Brimonidine, an alpha-2 adrenoceptor agonist, is an effective and safe medication which is~     widely used in glaucoma treatment. Although it is known that it is quickly taken up by the~     cornea following topical administration and that the cornea has alpha-2 adrenoceptors there~     are only few studies available on the impact brimonidine has on the cornea. The aim of the~     study is to find out~        1. whether topical administration of brimonidine results in interaction with corneal~          alpha-2 adrenoceptors in terms of an increase in corneal thickness and~        2. whether there are any differences between the response corneal epithelium, stroma and~          endothelium show to alpha-2 adrenoceptor stimulation.~   "
176858|NCT01250223|"~     The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic~     Factors Project which permitted the development of the Follicular Lymphoma International~     Prognostic Index (FLIPI).~      The F2-study is designed as a prospective collection of information potentially useful to~     predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are~     to validate the FLIPI and to verify whether a prognostic collection of data would allow the~     development of a more accurate prognostic index.~   "
176859|NCT01250210|"~     The primary objective was to evaluate the adequacy of ovulation suppression, cycle control,~     and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2 different~     doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE) during 3~     consecutive cycles of administration of each treatment.~   "
176860|NCT01250197|"~     This is a double-masked, single-center, crossover study in which normal volunteers will be~     randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8~     days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment~     for 8 days.~   "
176862|NCT01250171|"~     This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg~     or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the~     pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were~     assessed. Blood samples were collected for the analysis of the effect of secukinumab and~     canakinumab on select biomarkers.~   "
176863|NCT01250158|"~     The purpose of this study is to determine whether the PILP-kit can be safely used, within~     specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic~     drug for the treatment of patients with unresectable liver metastases.~   "
177080|NCT01247311|"~     Individuals with kidney disease have a high risk of heart disease. This is not related to~     traditional risk factors, such as high blood pressure, high cholesterol or being overweight.~     A lack of vitamin D could be the reason why blood vessels become damaged and could explain~     the link between heart disease and kidney disease.~   "
176864|NCT01250145|"~     This study is a Phase 1, multi-center, 2-part, subject- and investigator-blind, randomized,~     placebo-controlled, multiple dose study of transdermal teriparatide (80-µg dose) in healthy~     postmenopausal women. Part A will examine the cumulative irritation and adherence of the~     transdermal patch, and Part B will examine skin sensitization and adherence. Two separate~     groups of subjects will be enrolled for Part A and Part B of the study. All screening~     procedures will take place up to 28 days prior to enrollment.~   "
176865|NCT01250132|"~     Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of~     100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults~     showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most common~     deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic~     (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits~     (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of~     view, the lesional mechanism responsible for hypopituitarisms would be a damage of~     hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits~     and the potential beneficial effects of replacement therapy on quality of life, tiredness,~     loss of energy and productivity, justify the systematic detection of the deficits in patients~     with moderate to severe TBI.~      Study hypotheses :~      At the present time, the lack of data in children does not give us the opportunity to affirm~     that one part of the symptoms showed by children with post-TBI neuropsychological sequelae,~     are linked to pituitary deficiency and that they can be improved with a replacement therapy.~      Firstly, it is essential to better understand the natural history of post-TBI pituitary~     deficiencies, studying the connexion between observed deficiencies in acute and late phase of~     sequelae.~   "
176866|NCT01250119|"~     This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in~     newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer~     (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm~     study to evaluate progression-free survival and quality of life with first-line Tarceva~     (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily.~     Anticipated time on study treatment is until progressive disease or unacceptable toxicity~     occurs. Patients with negative EGFR mutation results will be offered treatment as per the~     centre's standard of care.~   "
176867|NCT01250106|"~     The investigators aim to test the hypothesis that Lactobacillus Reuteri-enriched microbiota~     improves insulin sensitivity and glucose tolerance in obese healthy and obese type 2 diabetes~     patients by improving gut hormone secretion and compare these findings to healthy lean~     subjects.~   "
176868|NCT01250093|"~     In order to investigate the therapeutic effect of acupuncture on chronic neck myofacial pain~     syndrome, the investigaotrs designed a pilot study of a single-blind randomized controlled~     trial. A total of 34 chronic neck myofacial pain syndrome patients were selected from~     Department of Neurology of Nantou Hospital, Department of Health. The age ranged from 18 to~     85, and all subjects were full informed consent and volunteers. They were divided into two~     groups of 17 subjects randomly as follows: acupuncture group, acupuncture stainless needles~     were inserted into bilateral Fenhchi, Jianliao and Houxi acupoints, respectively. The~     acupuncture needles then were manual twist and de Qi, and remain for 20 min; sham acupuncture~     group, the methods were identical the acupuncture group, but acupuncture stainless needles~     were inserted into subcutaneous tissue only. All the subjects were treated with acupuncture~     two times per week and continuously three weeks, i.e. Six times acupuncture treatment. The~     therapeutic effect of acupuncture was assessed before and finishing six times acupuncture~     treatment, and four weeks and twelve weeks after stopping acupuncture, respectively. The~     index of acupuncture therapeutic effect was according to the range of motion (ROM) of the~     cervical spine, the intensity of pain (Short-Form McGill Pain Questionnaire; SF-MPQ) and~     quality of life (SF-36). The investigators expect acupuncture apply to bilateral Fenhchi,~     Jianliao and Houxi acupoints may relief the pain and motion of chronic neck facial pain~     syndrome patient, and also improves the life quality.~   "
176869|NCT01250080|"~     Glutamine is the most abundant nonessential amino acid in the human body. Besides its role as~     a constituent of proteins and its importance in amino acid transamination, glutamine may~     modulate immune cells.~      The innate immune system is the first line of host defence against pathogens and in most~     cases sufficient to eliminate invading microbes. Mammalian Toll-like receptors (TLR) comprise~     a family of germ line-encoded trans-membrane receptors which activation leads to the~     induction of inflammatory responses, phagocytosis but also to the development of antigen~     specific adapative immunity.~      It has been postulated though not formally proven yet that glutamine beneficial effect could~     be due to a positive effect on the innate immune system. Given the importance of TLRs and~     TLRs-dependent signalling in host defence against infections we hypothesized that glutamine~     may increase the expression and/or functionality of TLRs which in turn may have beneficial~     effects to clear infections.~   "
176870|NCT01250067|"~     In this proposal, in addition to the conventional MRCP recording, the dipoles and sources of~     the different subcomponents of MRCP will also be analyzed with the brain electric source~     analysis (BESA) to evaluate the difference in the solutions and source strength underlying~     the MRCP between normal controls and patients with ET.~   "
176871|NCT01250054|"~     The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.~   "
176872|NCT01250041|"~     Strength of the Quadriceps Muscle is key to recover from Total Knee Arthroplasty. In this~     study we compare two techniques for pain control after total knee arthroplasty in terms of~     preserving the motor function (the strength of the quadriceps muscles of the thigh) which~     will facilitate the rehabilitation and accelerate the hospital discharge. We will use~     ultrasound guided technique to block either the femoral nerve in the control group or the~     saphenous nerve in the experimental group. The primary outcome is the functional capacity and~     the impact of each block on the ability to walk by measuring the distance patients are able~     to walk in two minutes in post operative day one in the two groups. The secondary outcome is~     the morphine consumption in the two groups.~   "
176963|NCT01248845|"~     Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory~     pattern of various level of assistance delivered by the ventilator in intubated spontaneously~     breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist~     (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure,~     transesophageal EMG signal and transcutaneous EMG signal will be recorded.~   "
176873|NCT01250015|"~     To establish whether provision of numerical data, framed as event rates and illustrated by~     pictograms, and including figures for all-cause mortality, affects subjects' attitudes to~     colorectal cancer (CRC) screening.~      Design and Intervention. Randomised questionnaire and telephone study comparing the responses~     of a control group given the standard National Health Service (NHS) CRC screening information~     with the responses of an intervention group given the same information but enhanced with~     additional numerical and pictorial information.~      Setting~   "
176874|NCT01250002|"~     Although ambulatory gynecological laparoscopy is considered to be a minimally invasive~     surgical procedure, only 60% of patients undergoing this procedure are satisfied with~     postoperative pain control. Postoperative pain can lead to physiological, immunological and~     psychological derangements in patients.It also has been shown to be the most common cause of~     hospital admission after outpatient surgery.~      Opioids constitute the most commonly used pain management strategy after surgery, however~     they have many undesirable side effects including nausea, vomiting and respiratory~     depression. Different strategies have been developed to decrease the amount of opioid~     required after surgery. Opioid sparing drugs as well as regional anesthesia have been shown~     to be effective. Systemic administration of lidocaine has been shown to decrease opioid~     consumption, improve recovery of bowel function and promote a better recovery after inpatient~     procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and~     anti-inflammatory properties. It also has an excellent safety profile when give by a low-dose~     infusion.~      The improvement of surgical technique and anesthesia care has made major adverse outcomes~     infrequent, especially in the ambulatory setting. Assessing patient's quality of recovery has~     become an important outcome in several studies. The patient's capacity to return to his~     normal activities is one of the most important sign of a successful outpatient procedure and~     it has significant economic implications.~      Quality of recovery -40(QoR-40) is a validated 40 item instrument to assess the quality of~     post-operative recovery. Myels et al. have concluded that the QoR-40 would be a useful~     outcome measure to assess the impact on changes in health care delivery, but anesthesia~     studies underutilize this instrument.~      The research question for the study is; does the use of systemic perioperative lidocaine~     improve quality of recovery after outpatient laparoscopy?~   "
176875|NCT01249989|"~     The average adult has a poor quality diet and sedentary lifestyle, but the best way to~     produce sustained healthy change remains unknown. The MBC2 intervention uses handheld~     technology to help individuals monitor and transmit information about their eating and~     activity remotely to a behavior coach. The proposed trial tests whether MBC2 intervention~     improves diet and activity more than a stress management control condition, and whether~     changing multiple health behaviors is best achieved by changing them all at the same time, or~     one after another.~   "
176876|NCT01249976|"~     Removal of a central venous catheter (CVC) is often useful to prove its responsibility in a~     bloodstream infection. To avoid unnecessary removal of CVC, some catheter-spearing diagnostic~     methods have been recently developed. The aim of the study is to evaluate three~     catheter-spearing diagnostic methods in critically ill children: 1) the measurement of the~     differential time to positivity between a blood culture drawn from a peripherical vein and~     another one drawn through the CVC; 2) the exam of a blood sample drawn for the CVC and~     stained by acridine orange leucocyte cytospin test; 3) the semi-quantitative skin culture of~     the area around the insertion site of the CVC.~   "
176877|NCT01249963|"~     The aim of the study is to evaluate the beneficial effects of the administration of enteral~     nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent~     maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and~     medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All this against~     other specific product.~      The main objectives of this project are:~        -  Comparing the tolerance of both preparations.~        -  Comparing the evolution of nutritional status in both groups.~        -  Comparing the evolution of inflammatory parameters in both groups~   "
176878|NCT01249950|"~     single-center study carried out in order to evaluate in prospective among patients seen or~     treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the~     potential number of patients eligible for surgery.~   "
176879|NCT01249937|"~     In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of~     blindness. This disease was once thought to be a natural part of aging, but recent research~     has introduced effective treatments. ARMD is related to the body initiating an immune~     response in the eye, as if responding to an infection. Vision is impacted as ocular tissue~     becomes inflamed and new blood vessels form at the back of the eye, a process called~     angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels~     and impair the eye's structure and function. Many studies have shown that ranibizumab, a drug~     that stops the formation of new blood vessels (an anti-angiogenic agent) can delay damage to~     the eye and often restore vision. The investigators believe the best drug therapy will also~     stop the inflammation. Triamcinolone acetonide, a steroid drug, has shown the potential to~     effectively reduce inflammation in this application. The investigators aim to investigate if~     patients receiving a combination treatment of ranibizumab and triamcinolone acetonide improve~     their visual abilities more than those receiving just ranibizumab treatment alone.~     Secondarily, the investigators will also investigate how often patients receiving each drug~     therapy regime require re-treatment and how often they experience further vision loss.~   "
176880|NCT01249924|"~     Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent~     postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients~     with moderate and severe OSA.~   "
176881|NCT01249911|"~     Randomized, doble blind, clinical, controlled trial aimed to investigate the role of~     Lactobacillus reuteri DSM 17938 in the prevention of gastrointestinal and respiratory tract~     infections in mexican children who attend day care centers.~      Primary Outcome: The primary outcome will be days with diarrhoea. Secondary Outcomes: a)~     Days with respiratory tract infections (RTI); b) Days of absences from day care centre; c)~     Days of antibiotic use; d) Days of medical office visits or emergency visits; and e) Direct~     and Indirect costs.~      Methods: Prospective, randomized, double blind, placebo controlled trial to realize in 260~     healthy term infants, born at term (≥36 weeks of gestation), 6 to 36 months old, who will be~     recruit from Child Care Centers in Mexico and randomly allocated to receive either 1 x 108~     colony-forming units of Lactobacillus reuteri DSM 17938 or placebo, each day for 12 weeks,~     follow up for other additionally 12 weeks of observation. Days with respiratory tract~     infections (RTI); days of absences from day care centre; days of antibiotic use; days of~     medical office visits or emergency visits; and direct and Indirect costs will be compare~     between groups using bi-variate, multiple lineal regression analysis and cost-effectiveness~     analysis~   "
177081|NCT01247298|"~     This investigational study will evaluate if using a combination of TACE along with high dose~     SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.~   "
176882|NCT01249898|"~     Scaphoid fractures are the most common carpal bone fractures, and second most common wrist~     fractures (second to distal radius fractures). Lack of proper immobilization or displacement~     of these fractures commonly results in fracture nonunion or malunion followed by the~     development of wrist post-traumatic osteoarthritis. In addition, proper reduction and~     fixation of these fractures are challenging to the most experienced hand surgeons.~      The investigators are going to follow-up the patients population suffering from Scaphoid~     fractures(nonunion included) for one year. The investigators will evaluate this follow up~     results in two ways:~        1. Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation.~        2. Treatment of scaphoid fracture non-union.~   "
176883|NCT01249885|"~     The purpose of this study is to examine pacifier sucking habits among children, and to assess~     implications of the oral habit - for example malocclusions and drooling. The effect of~     pacifier sucking will be recorded and compared to pacifier type and frequency of use.~   "
176884|NCT01249872|"~     Adequate postoperative analgesia can facilitate recovery following gastric bypass surgery for~     morbid obesity. The efficacy and safety of intravenous patient - controlled analgesia has~     been studied, but up to date no data are available concerning the use of thoracic epidural~     patient-controlled analgesia regarding the use of levobupivacaine combined with morphine in~     morbidly obese patients. The investigators' aim in this prospective, randomized,~     double-blinded study was to compare the analgesic effectiveness, the dose requirements and~     side effects of thoracic epidural patient controlled analgesia 0.1% and 0.2% levobupivacaine~     combined with a continuous epidural administration of morphine, with or without a loading~     dose, after open gastric bypass for morbid obesity.~   "
176885|NCT01249859|"~     Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the~     upper digestive tract in western countries~        -  Discordant results in the literature concerning the prognosis value of the presence of~          signet ring cells.~        -  Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often~          in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more~          frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo~          resistance (vi) the need for a specific therapeutic strategy compared to non-signet ring~          cell adenocarcinomas.~      Primary objective To test the hypothesis that 5-year survival rate is significantly lower in~     the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the~     upper digestive tract~      Secondary objectives~        -  Impact of neoadjuvant CT on overall survival~        -  Impact and differential diagnostic value of linitis~        -  R0 resection rates~        -  3 years recurrence free survival~        -  Overall 3 years survival~        -  Prognostic factors~        -  Prognostic value of the presence of a minority quota of signet ring cell~        -  Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in~          non-resected patients~        -  Tolerance of (radio) chemotherapy for ADCI~      Methodology Intention to treat retrospective case-control multicentric study A pairing on~     demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be~     done to ensure comparability in case control study groups.~      Inclusion criteria All consecutive patients taken care of, for a proven histologically~     adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in~     surgical or medical oncology investigator centers, will be saved in a given database.~      For whom the first consultation took place between January 1997 and January 2010~      Exclusion criteria Histological type other than adenocarcinoma Other localization than~     esogastric junction, esophagus or stomach~      Planned study period The data will be collected over a period from January 1997 to January~     2010.~      The objective is to complete the data collection for summer 2010.~   "
176886|NCT01249846|"~     The purpose of this study is to assess the efficacy and the safety of Chlorhexidine Gluconate~     Chip (PerioChip®) in frequent treatment versus routine treatment in therapy of adult chronic~     periodontitis.~   "
176887|NCT01249833|"~     This study has been designed to determine if subjects treated with oseltamivir in addition to~     standard of care treatment for influenza demonstrate a greater improvement in attention /~     working memory / processing speed / mood as compared to subjects receiving standard of care~     alone. The cognitive tests employed are objective measures developed and administered online~     by HeadMinder Inc.~   "
176888|NCT01249820|"~     The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given~     intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem~     cell transplant following myeloablative chemotherapy or patients receiving intensive~     chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease.~   "
176889|NCT01249807|"~     Cancer Screening is necessary for promoting cancer prevention in the area of public health.~     The Department of Health, Executive Yuan of the Republic of China has expanded and included~     colon cancer screening, oral cavity cancer screening, breast cancer screening, and cervical~     cancer screening in national-wide preventive healthcare services. However, most of the~     Taiwanese do not have the concepts of what cancer screening is and regular participation of~     cancer screening. This will easily cause their neglect of quality of personal healthcare and~     habits of cancer screening. Recently, in order to reach the national goal of cancer~     prevention, the parallel methods, multi-promotion for reinforcing concepts and free cancer~     screening, have been utilized to cultivate Taiwanese people's active participation of cancer~     screening. Therefore, this study will use health service utilization model to investigate~     Taiwanese people's concepts of cancer-related knowledge and the major causes of low~     participation of cancer screening.~      In order to investigate Taiwanese people's health service utilization model and quality of~     health life, this study first review the related regulations and screening rates of cancer~     prevention, including cancers of colon, oral cavity, breast, and cervical, in Taiwan. In~     addition, the structured questionnaire will be conducted to collect, investigate, and analyze~     the relationship between the willingness of participating the aforementioned cancer screening~     and personal characteristics, quality of health life, medical history, and concepts of~     cancer, etc. It is expected that the results of this study will provide accurate and~     effective promotions of cancer screening to medical institutions and medical affairs to~     reinforce the concepts of participation for raising the rates of cancer screening;~     furthermore, to awaken Taiwanese people's crucial awareness of early treatment improves the~     chances of recovery on cancer.~   "
176890|NCT01249794|"~     Patients with respiratory failure following cardiac surgery are randomized to receive~     standard therapy versus non invasive ventilation. The hypothesis is that patients receiving~     non invasive ventilation will perform better than those who received standard therapy.~   "
176891|NCT01249781|"~     The purpose of this study was to explore caregivers stress, family functioning, social~     support and family resilience of families whose children had acute lymphoblastic leukemia.~     The significantly correlation among caregivers stress, family functioning, social support and~     family resilience was also explored.~   "
176892|NCT01249768|"~     Background:~      Parkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy,~     Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease~     entities with partly common symptomatology. Especially very early in the course of disease,~     the differentiation between both disease entities can be challenging, even for specialists in~     the field of movement disorder. However, the establishment of a correct diagnosis is very~     important for adequate patientcounseling, treatment and the correct inclusion of patients in~     research trials. Ancillary diagnostic investigations are looked upon to aid in this~     diagnostic dilemma.~      Objective:~      To investigate the value of ancillary diagnostic investigations, more specific MRI, analysis~     of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to~     differentiate Parkinson's disease and the Atypical Parkisonisonian disorder.~   "
176893|NCT01249755|"~     Recently our ICU research group developed and validated a delirium prediction model in the~     NetherlandsThis. This model has a high predictive value. We want to examine what the~     predictive value is in ICUs of other European countries.~   "
176894|NCT01249742|"~     Background~      The treatment of diabetes is multidisciplinary. Alignment of care of the various professional~     disciplines is, however, not always optimal. This can lead to confusion about treatment~     interventions and behavioral advices. In adolescence, good fine-tuned care is of extreme~     importance because of the difficulties in regulation of the disease in this phase of life~     (Snoek, 2004). These difficulties are due to biological changes but also to~     socio-psychological developmental changes. The adolescents' psychological development demands~     more autonomy and responsibility for the diabetes (care) by the adolescent. The social~     development can conflict with the treatment regime, because of the adolescents' social needs~     (ADA, 2001; Houdijk, 1998; Snoek, 2004). In this study the investigators assess whether an~     interactive website, on which adolescents with diabetes and their treatment team can~     communicate, leads to better alignment of care and better control over the disease.~      Intervention~      The diabetes has great impact on the adolescents' everyday life. Finding a balance between~     more autonomy, participating in social life with (healthy) peers and control of the disease~     is difficult and seems to act as a thread during this phase in life.~      This can lead to questions and uncertainty at any given moment. The interactive website~     provides the adolescent access to information and to his or her individual treatment plan and~     advices fitted to his or her condition and life. The adolescent can pose questions at any~     given moment through the online forum and their personal treatment page. Since the treatment~     team answers the question within a day, fit between diabetes care and adolescents' everyday~     life is optimized.~      Research question~      Does an online interactive treatment environment, on which adolescents with diabetes can~     communicate with their treatment team, lead to better fit of care and to better disease~     control?~   "
176895|NCT01249729|"~     We use the three-dimensional image software reconstruct MRI. The propose of this research~     purposes as follows: 1. 3D reconstructed image processing from MRI to realize the short term~     nervous system response after dynamic acupuncture stimulation.2. Realizing the corresponding~     area in the brain caused by electroacupuncture. 3. Realizing the connection between~     electroacupuncture stimulation and brain physics, chemistry, and physiology. The implement~     the two-dimentional image into three-dimensional image by Amira software, in order to find~     out the difference of the pre-and post- response of the nervous system. In addition, we will~     use describe statistics and Paired t-test statistical analysis, compare the statistical~     difference of blood oxygen concentration.~   "
176896|NCT01249716|"~     To assess the effect on geriatric patients of follow-up home visit including nutrition.~      The hypothesis is that this can prevent hospital readmissions, and has a positive impact on~     functional abilities and quality of life~   "
176897|NCT01249703|"~     1. Find the early diagnostic markers of erectile dysfunction;~        2. Study the warning role of ED in some diseases.~   "
176898|NCT01249690|"~     The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen~     in newly diagnosed multiple myeloma(MM).~   "
176899|NCT01249677|"~     Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2~     diabetes. The investigators examined, whether chronic basal insulin treatment with insulin~     glargine lead to improvements in glucose-induced insulin secretion.~   "
176900|NCT01249664|"~     VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to~     choroidal neovascularization secondary to pathologic myopia. This will be a~     placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye into~     the affected eye (and repeated injections if required), and 1 out of 4 patients will receive~     a sham injection requiring no needle stick, but making the patient unaware of whether or not~     he received active treatment.~      Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham~     patients may receive active treatment.~      Total duration of the study will be 48 weeks.~   "
176901|NCT01249651|"~     Administration of esomeprazole 40 mg to subjects who still had heartburn after receiving~     rabeprazole 20 mg once daily for 4 to 8 weeks will result in statistically significant~     improvement of heartburn after 8-week treatment.~   "
176902|NCT01249638|"~     Patient with multiple metastases, not eligible for surgery, might not profit from intensive~     chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease~     control may be a better choice for first line treatment. Therefore this study investigates~     the combination of capecitabine and bevacizumab versus the combination of capecitabine,~     bevacizumab and irinotecan. In case of progressive disease, the therapy in patients treated~     with capecitabine and bevacizumab is intensified by adding irinotecan. Primary endpoint is~     time-of-failure strategy (TFS) comparing both treatment arms.~   "
176903|NCT01249625|"~     Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace,~     there is very little clinical evidence that respirators prevent healthcare personnel (HCP)~     from airborne infectious diseases. Scientific investigation of this issue has been quite~     complicated, primarily because the use of respirators has become the standard of care for~     protection against airborne diseases in some instances, even without sufficient evidence to~     support their use. The key question remains: How well do respirators prevent airborne~     infectious diseases? The answer to this important question has important medical, public~     health, political and economic implications.~   "
176904|NCT01249612|"~     With this study the investigators wish to (1) investigate the acute effect of knee joint~     icing on knee-extension strength shortly after total knee arthroplasty (TKA); and (2)~     investigate the acute effect of knee joint icing on knee pain, knee joint circumference and~     functional performance shortly after TKA.~   "
176905|NCT01249599|"~     The aim of this prospective single-center study is to evaluate endothelial function, arterial~     compliance, sympathetic nervous activity at rest and after mental and physical stress,~     carotid atherosclerosis, oxidative stress parameters, quality of life and platelet adhesion~     in patients with apical ballooning syndrome and age-matched controls.~   "
176906|NCT01249586|"~     E-learning material increases the student knowledge level before the traditional class of~     blindness prevention and help to fix this information a short period (one month) after the~     class.~   "
176907|NCT01249573|"~     This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis~     in the treatment of an acute ankle sprain. These treatments will be compared to a placebo~     group.~   "
176917|NCT01249443|"~     This phase I clinical trial is studying the side effects and the best dose of vorinostat when~     given together with paclitaxel and carboplatin in treating patients with metastatic or~     recurrent solid tumors and human immunodeficiency virus (HIV) infection. Vorinostat may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     vorinostat together with paclitaxel and carboplatin may kill more tumor cells.~      NOTE: An administrative decision was made by NCI to halt further study of vorinostat in this~     specific patient population as of February 1, 2013. No patients remain on vorinostat. Going~     forward this study will determine the safety and tolerability of the paclitaxel and~     carboplatin combination in this patient population.~   "
176908|NCT01249560|"~     The objective of the antiretroviral treatment is to inhibit the viral replication,~     estimated(appreciated) by the measure of the viral plasmatic load(responsibility). In this~     inhibition of the viral replication usually joins an immune reconstruction [ 1 ].~     Nevertheless, a viro-immunological dissociation, i.e. an undetectable viral~     load(responsibility) and an absence of immune reconstruction, is regularly observed. It is~     now turned out that an undetectable viral load(responsibility) does not correspond to the~     total absence of viral replication and that it is possible to detect of the intracellular~     pro-viral DNA . Raltegravir ®, because of its mode of action(share) inhibiting the~     integration of the pro-viral DNA in the chromosomes of the infected cells(units) , could~     decrease the intracellular reservoir of monocyte-macrophages, improve the homeostasis, so~     optimizing the cooperation lymphocytes T - macrophages. Several experimental data suggest~     that the regression of the abnormalities of cellular interactions, and the rate of apoptose~     abnormally raised(abnormally brought up) by cells(units) T at the patients in~     viro-immunological dissociation, could be obtained .~      This study aims at measuring the impact of Raltegravir ® on the viral reservoirs lymphocyte~     and monocyte, to quantify the expression of the molecules of costimulation, the~     source(spring) of intercellular interactions lymphocytes - monocytes, and to measure the rate~     of apoptose of the cells(units) T.~   "
176909|NCT01249547|"~     This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety~     of single-agent axitinib in recurrent or metastatic NPC patients who failed at least one line~     of platinum based chemotherapy.~   "
176910|NCT01249534|"~     Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive~     protein (CRP) in the postoperative course. The aim of this study was to evaluate the~     diagnostic accuracy of CRP for postoperative inflammatory complications after~     gastroesophageal cancer.~   "
176911|NCT01249521|"~     This is a clinical trial investigating the effectiveness and safety of the combination of the~     study drugs bevacizumab and AMG386 in patients with advanced (metastatic) chemotherapy-naive~     bowel (colorectal) cancer. Chemotherapy has a significant impact in metastatic bowel cancer~     in terms of maintenance of quality of life and extension of survival. However, ultimately~     tumours will develop resistance to these agents and further treatment options are urgently~     required.~      Angiogenesis is a process that results in the formation of new blood vessels. Similar to~     normal tissues, solid tumours require new blood vessels for growth and survival. Hence, drugs~     targeting angiogenesis may be useful treatment options for patients with bowel cancer.~      AMG386 and bevacizumab act on 2 different pathways relevant to angiogenesis. There is~     evidence from laboratory and animal studies to suggest that such a combination could be~     useful as a cancer treatment. Previous studies in humans have shown that AMG386 and~     bevacizumab can be combined safely.. This study aims to evaluate the effectiveness and safety~     of the combination of AMG386 and bevacizumab in patients with advanced bowel cancer.~      40 patients from approximately four hospitals in Australia will participate in this trial,~     with approximately 20 patients being enrolled at Austin Health. All participants will receive~     the same treatment.~   "
176912|NCT01249508|"~     This study aims to evaluate a nutrition labelling program in improving university canteen~     customers' dietary pattern and behavioural determinants (e.g. knowledge).~   "
176913|NCT01249495|"~     The purpose of this study is to investigate the rate of wound healing using sharp debridement~     using curette and to compare between such intensive treatment at hospital and treatment in~     primary care. A correlation between change in wound size and pro-inflammatory cytokines will~     also be made.~   "
176914|NCT01249482|"~     Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of~     proton-pump inhibitor has been reported in previous studies. In patients with concurrent~     gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of~     Helicobacter pylori (H. pylori)will aggravate acid-related symptoms after discontinuation of~     proton-pump inhibitor remains elusive Objective: This study aims to investigate the incidence~     and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in~     reflux patients receiving H. pylori eradication.~   "
176915|NCT01249469|"~     Background: Solar lentigines are a common dermatologic condition that manifest as~     circumscribed single or multiple brownish macules usually located on sun-exposed skin such as~     face, hands or forearms. An effective, safe, daily-use, homecare whitening product may~     alleviate the cosmetic concerns for the general population. The efficacy and safety of the~     previous generation BEX-2009 (Blanc Expert Spot Eraser, L'Oreal, France), a whitening~     cosmetic product containing ellagic acid, salicylic acid, licorice root extract, etc., has~     been established in Caucasian and Asian populations with facial solar lentigines.~      Objective: The purpose of this placebo-controlled, single-center study is 1) to evaluate the~     efficacy of the new generation whitening cosmetic product BEX-2011 (Ultimate Whitening Spot~     Eraser, L'Oreal, France) in the improvement of solar lentigines on the dorsum of hands or~     forearms, and 2) to evaluate the efficacy of BEX-2011 by harmonic generation microscopy to~     obtain information of the epidermal melanin continuum, compared to other standard tools for~     melanin measurement.~   "
176916|NCT01249456|"~     Title of study: An observational, multicenter study on the safety and efficacy of Femara®~     (Letrozole) as an extended adjuvant treatment in breast cancer patients who completed~     adjuvant Tamoxifen or Toremifen treatment~      Objectives:~      The major objective of the study is to assess safety and efficacy of Femara® in women who had~     undergone resection of a primary breast cancer and subsequently received prior adjuvant~     tamoxifen or toremifen therapy for 5 years in real-life condition.~      The study aims at the following objectives:~        1. To identify unknown adverse reactions, especially serious adverse reactions~        2. To evaluate incidence and descriptions of adverse reactions under the routine drug use~        3. To identify factors that may affect the safety of Femara®~        4. To identify factors that may affect the efficacy of Femara®~      Methodology: This will be an open-label, multi-center, single-arm, observational phase IV~     study.~      Number of centers & patients: Approximately 610 (planned No. of patients for total study~     period) patients from 4 centers will be enrolled in this study.~      Population: Postmenopausal early breast cancer patients who have finished adjuvant treatment~     with Tamoxifen or Toremifen for 5 years after curative surgery as indications described in~     local product labeling.~      Investigational drug: Femara® will be administered orally as described in dose &~     administration of local product labeling up to 3 years.~      Study duration: FPFV May. 2006, LPFV Dec. 2011. Study drug will be administered for up to 3~     years with renewal of contract on yearly basis.~   "
176918|NCT01249430|"~     This phase I trial studies the side effects and best dose of azacitidine when given together~     with mitoxantrone, etoposide phosphate, and cytarabine in treating patients with acute~     myeloid leukemia that has returned after a period of improvement or does not respond to~     treatment. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone, etoposide~     phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Azacitidine may help mitoxantrone, etoposide phosphate, and cytarabine work better by making~     cancer cells more sensitive to the drugs.~   "
176919|NCT01249417|"~     The purpose of this research study is to determine whether Dysport® is effective in the~     treatment of increased stiffness of the calf muscles and to evaluate the safety of this~     treatment in children with Cerebral Palsy. In addition this study will also check whether~     Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.~   "
176920|NCT01249404|"~     The purpose of this research study is to assess the efficacy of Dysport® compared to placebo~     in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or~     traumatic brain injury.~   "
176921|NCT01249391|"~     Osteoarthritis (OA) is the most common form of arthritis and the hand is the most frequently~     affected site.Interphalangeal (IP) joints (the small joints of the fingers) are often~     involved causing pain, progressive loss of hand function and deformity. Deviation, or bending~     to the side, of IP joints (IPJs) with significant functional and cosmetic consequences for~     the individual is common. There are no drugs which can slow the disease process so there is~     reliance on symptomatic treatment such as pain relief and hand therapy. Joint thermoplastic~     splinting (moulded plastic splints that are custom-made) is employed by hand therapists in~     other settings, but to the investigators knowledge no studies have formally investigated the~     effect of splinting in IP OA.~      By resting inflamed tissues and correcting joint alignment, a beneficial role for splinting~     in IP OA is likely. In this study, the investigators want to test whether thermoplastic~     splinting of deviated IP joints due to OA will 1) improve joint alignment 2) ameliorate soft~     tissue inflammation, and whether as a consequence 3) pain and overall hand function will be~     improved.~      Adults with hand OA with 'affected' IP joints (symptoms from OA associated with deviation of~     the joint on X-ray)will be recruited from a specialist hand osteoarthritis clinic. Initially~     this will be for distal IP (DIP) joints. In the intervention group (30 patients), an~     'intervention' joint for splinting will be identified as the most painful deviated DIP joint~     in the past week leading up to enrolment. Up to 3 other 'affected' DIP joints on either hand~     will not be splinted but will be monitored as 'control' joints. In the control group (15~     patients), an affected joint will be monitored but not splinted. Assessment of joint pain,~     hand function by a hand therapist, deformity (by X-ray)and joint inflammation will take place~     at baseline, during and at the end of splinting period of 3 months, and also at 6 months,to~     assess whether any changes are persistent. In this way, the efficacy of splinting of IP~     joints in OA will be assessed.~   "
176922|NCT01249378|"~     In this study, the investigators are interested in investigating how the emulsification state~     and amount of fat in a meal can modify the kinetics of postprandial lipemia and inflammatory~     outcomes (including endotoxemia) in obese vs lean subjects.~      10 lean and 10 obese volunteers will come 3 times (>3 weeks apart) at the investigation~     center to receive a standard breakfast containing milk fat (10 g non emulsified, or 40 g non~     emulsified, or 40 g finely emulsified). 13C triglyceride stable isotopes will allow to follow~     the metabolic fate of fatty acids and calculate lipid oxidation by breath test. Blood~     sampling throughout digestion will allow to measure metabolic, lipid and inflammation~     parameters. Stool will be analysed to determine lipid losses in faeces and to phenotype~     microbiota.~   "
176923|NCT01249365|"~     This extension study is designed to assess the safety of GSK Biological's HPV vaccine~     GSK580299 in female subjects who took part in the primary study NCT00294047 and received the~     control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the~     subject's age group (26 years and older). This study is thus conducted to enable all women~     who received the control placebo in the primary NCT00294047 study to receive the GSK580299~     vaccine.~   "
176924|NCT01249352|"~     The primary objective of this study is to assess the efficacy of nimotuzumab in combination~     with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer,~     comparing it to that of the conventional treatment with radiation and chemotherapy.~      The secondary objective of this study is to assess the health-related quality of life for the~     nimotuzumab in combination with chemotherapy and radiotherapy regimen, compared to the~     standard chemoradiation regimen in the treatment of inoperable locally advanced esophageal~     cancer.~   "
176925|NCT01249339|"~     In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users~     will be given repeated doses of four different types of portion snus: General, Catch,~     Catch Mini and Catch Dry Mini. Each portion of used snus will be collected and frozen~     (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific~     nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation~     of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco~     specific nitrosamines (TSNAs) respectively, will be done for each type of snus.~   "
176926|NCT01249326|"~     The main objective of the study is to evaluate the protein requirement associated with~     postoperative weight loss caused by by-pass (shunt which leads to a certain degree of~     malabsorption) or sleeve gastrectomy (more technically conservative with less malabsorption),~     through the study of nitrogen balance. The benefit of protein supply easily absorbed and with~     high essential amino acids content (proteins fast soluble milk) on protein metabolism and~     muscle function will also be studied. Endotoxemia and intestinal flora variations were~     measured before and after bariatric surgery.~   "
176927|NCT01249313|"~     Candidemia is the fourth leading cause of hospital-acquired infection in USA. In CMUH, it~     caused 9% hospital-acquired bloodstream infection in 2008 and 2009. In addition to increased~     mortality, candidemia also increased hospital stay and cost. There is a trend of increased~     cases of candidemia in recent years in CMUH. Early empirical and target treatment can reduce~     mortality and shortened length of hospital stay.~      In the past, most prior studies in Taiwan dealt with risk factors for mortality rather than~     for candidemia and also focused at in vitro susceptibility to antifungal agents. In this~     study, the investigators hope to analyze the candidemic cases from 2003 to 2009, estimated~     1000 cases. There were some rare Candida species. Therefore, the investigators hope to do~     case study for these diseases to provide the epidemiology of candidemia in CMUH. The result~     can help clinician in predicting the disease and its outcome. Besides, it also provides the~     epidemiology of candidemia in mid-Taiwan.~   "
176928|NCT01249300|"~     Introduction Patients with stroke may be silent aspirators or at risk for laryngeal~     penetration or aspiration because of abnormal oropharyngeal functioning and thus are at risk~     for aspiration pneumonia and its serious effects. By providing identification of the~     components of the abnormal swallow, and comparing swallowing across tasks, the investigators~     may avoid aspiration and can instruct patients on preventative or compensatory swallowing~     techniques.~      Materials and methods~        1. Oral examination-A neurologist and speech pathologist examine the patient's swallowing~          function. The patient is interviewed about difficulties with food intake, chewing and~          swallowing during meals.~        2. Ultrasound examination-Ultrasound creates image of areas inside the body using sound~          waves. With the patient in a sitting position, a 3/4-inch transducer (device for~          transmitting and receiving sound waves) is placed under the chin to visualize epiglottis~          movements during swallowing.~        3. Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of~          flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the~          tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and~          videotaped at the same time epiglottis movement will be trace with ultrasound. The~          barium is given in three consistencies-thin, medium and thick (pudding-like).~      The investigators will study the oral, pharyngeal and upper esophageal phases of swallow~     using videofluoroscopy and correlate with ultrasound tracing of epiglottis movement in~     patients with stroke conditions. Most of the previous studies of swallowing have utilized~     diagnostic imaging technique to provide a complete swallowing assessment, but limited~     capabilities for screening large population of patients.~      INCLUSION CRITERIA: The Stroke Center inpatients and outpatients with known or suspected~     dysphagia can be included for study as well as patients who are admitted specifically for~     this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or~     choking when eating, shortness of breath during swallowing, food backing up into the mouth or~     nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained~     loss of weight.~      EXCLUSION CRITERIA: Patients who are severely demented or severely compromised will be~     excluded if they do not have sufficient cognitive ability to follow directions.~     Non-ambulatory patients will be excluded if they cannot be braced or supported within the~     fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to~     remain confined in the equipment.~      Analytic Methods The Student t test will be used to analyze the difference in epiglottis~     movements during swallowing amongst different phases. Levene's test for equality of variances~     will be applied to examine the variability of epiglottis movements during swallowing between~     the groups. All statistical analysis will be performed with SPSS.~   "
177082|NCT01247285|"~     This study compared the relative bioavailability (rate and extent of absorption) of 90 mg~     Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC~     WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy~     adult volunteers under non-fasting conditions.~   "
176929|NCT01249287|"~     A growing number of studies highlight the potential of stem cell transplantation as a novel~     therapeutic approach for stroke in animal model. But the stem cell therapy for chronic stroke~     patients has not been well investigated yet. In this study, the investigators will test the~     hypothesis that intracerebral peripheral blood hematopoietic stem cell (CD34+) (PBSC)~     transplantation induces neuroplasticity in chronic stroke patients. The remyelination of~     corticospinal tract in the lesion side, focal increased perfusion and increased cortical~     activity in the peri-infarcted area will be monitored by the functional MRI after stem cell~     therapy. The investigators study is aimed to find the potential mechanisms of the functional~     recovery after stem cell implantation. The investigators also hope to find image surrogate~     markers for prediction of patient outcome. The possible surrogate markers will be helpful in~     improving the treatment procedure and patient selection.~   "
176930|NCT01249274|"~     The investigators propose a placebo-controlled, randomized clinical trial that would enroll~     50 postpartum women with a history of cocaine abuse or dependence to assess whether~     progesterone (100mgs twice daily) decreases postpartum cocaine use.~   "
176931|NCT01249261|"~     The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on~     BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.~   "
176932|NCT01249248|"~     This is a double blind observational analysis of changes in heart rate variability using PD2i~     analyser in competitive athletes during strenuous exercise and competition.~   "
176933|NCT01249235|"~     The purpose of this study is to determine if patching the eye or a bandage contact lens along~     with Tylenol #3 is more effective for pain control following pterygium surgery.~   "
176934|NCT01249222|"~     Sepsis is one of the most prevalent and fatal diseases in intensive care units~     .unfortunately, therapeutic approach to sepsis has remained unchanged for many years.~     Nowadays, the role of cytokines in pathogenesis of sepsis is obvious. Continuous elevated~     levels of various cytokines in severe sepsis could result in uncontrolled inflammation~     status. Breaking of inflammatory cascade may lead to improvement in survival. It seems that~     modulation of inflammation is one of the strategic plans to conquest sepsis. Therefore,~     elimination of bacterial toxins and pro-inflammatory cytokines from the systemic circulation~     by plasmapheresis supposed to be rational approach.~      Researchers have done several attempts to clarify the efficacy of plasmapheresis in sepsis~     treatment. However because of inconsistent results, routine use of this procedure in patients~     with severe sepsis remains controversial.~      The aim of the present survey is to determine the effect of plasmapheresis on plasma levels~     of main pro-inflammatory cytokines and evaluate its therapeutic efficacy in improvement of~     outcome and treatment of severe sepsis.~   "
176935|NCT01249209|"~     This study is a pilot project to investigate any effect on these markers in conjunction with~     lifestyle changes / conservative treatment. Useful and significant information in this pilot~     project is intended to be used as background for further research on this issue in connection~     with a doctorate.~      What is the effect of two years of outpatient treatment for lifestyle change for weight~     markers, waist, BMI, HbA1c, HDL and LDL cholesterol, triglycerides and uric acid in adults~     with morbid obesity?~   "
176936|NCT01249196|"~     The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients~     with mild to moderate Alzheimer's disease.~   "
176937|NCT01249183|"~     Primary objectives:~      To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of~     age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.~      Secondary objectives:~      •Secondary immunogenicity objectives: To describe the immune responses 28 days after~     concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age~     and older To describe the immune response of VAXIGRIP according to European Medicines Agency~     criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)~      •Secondary safety objective: To describe the safety profile after vaccination in each group~   "
176938|NCT01249170|"~     Study to determine if pulmonary/critical care fellows will demonstrate increased competency~     in the behavioral skills necessary to facilitate family meetings focused on discussions of~     goals of care in the ICU from pre- to post-communication skills training.~   "
176939|NCT01249157|"~     Positron Emission Mammography (PEM) is a newly developed imaging examination of the breast~     that uses a radioactive glucose based tracer, which is a form of sugar attached to a low~     radiation agent, to detect cancer cells. The radioactive glucose based tracer is called~     fluorodeoxyglucose (FDG), and it is FDA approved. A PEM scanner is able to better detect~     cancer cells within the breast, more than a regular PET scanner. The PEM scanner is also FDA~     approved. This type of imaging may be able to see the breast cancer before it could be seen~     with mammograms and may be as good as or better than breast MRI.~      The purpose of this study is to compare the value of FDG Positron Emission Mammography (PEM)~     with contrast enhanced Magnetic Resonance Imaging (MRI) of the breast for patients with~     breast cancer. This study will also perform special pathology test to compare the FDG PEM and~     contrast enhanced breast MRI images with the results from the standard of care breast~     surgery. This may teach us more about the biology of each breast tumor.~   "
176940|NCT01249144|"~     This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to~     replace the natural crystalline lens after cataract extraction. The variables compared~     include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity~     outcomes three months after implantation.~   "
176941|NCT01249131|"~     This study will be an open-label, randomized, 3-way, 6-sequence crossover study in healthy~     participants for determining the relative bioavailability of the tablet formulation to the~     capsule formulation and the effect of food on the relative bioavailability of the tablet~     formulation.~   "
176942|NCT01249118|"~     The primary objective of Part 1 of this study is to evaluate the safety and tolerability of~     the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to~     evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of~     GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this~     study is to evaluate the safety of GDC-0973 administered orally and intravenously.~   "
177287|NCT01244568|"~     Researchers in this study will determine whether providing decision support interventions~     (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and~     alters their treatment decisions.~   "
176943|NCT01249105|"~     MK-2206 is a newly discovered drug that may slow or stop cancer growth. This drug has been~     used in other research studies, and information from those other research studies suggests~     that MK-2206 may help to slow or stop the growth of malignant gliomas. In addition, MK-2206~     has the capacity to cross the blood-brain barrier. The blood-brain barrier (BBB) is a~     separation of circulating blood and cerebrospinal fluid (CSF) in the central nervous system~     (CNS); and although it serves as a protective barrier, it can often interfere with~     potentially beneficial treatments reaching the brain successfully. Therefore, the~     investigators hope that because MK-2206 can successfully cross the blood-brain barrier, it~     will be more effective in patients. The purpose of this study is to see how well MK-2206~     works in patients with malignant gliomas and will be conducted in two parts: Part 1 and Part~     2.~      Part 1 of the study will investigate the effects of MK-2206 on Akt signaling in tumor tissue.~     Ten patients with recurrent GBM who require reoperation will receive a short pre-operative~     course of MK-2206. After recovery from surgery, patients will resume MK-2206 until disease~     progression or the development of unacceptable toxicities. Part 2 of this trial will be~     initiated only AFTER analysis of Part 1 data shows drug penetration into tumor tissue; if~     there is no significant drug penetration into the tumor and/or there is no reduction of pAkt~     levels, progression to Part 2 of the trial will be halted. The primary goal of Part 2 is to~     determine the therapeutic efficacy of MK-2206 as measured by 6-month progression-free~     survival (PFS6). In Part 2, 40 participants with GBM and 18 with anaplastic glioma will be~     treated with MK-2206 weekly at a dose selected on the basis of an ongoing phase 1 study.~     Treatment duration will be measured in 4-week cycles. Participants will remain on treatment~     until tumor progression, as long as there are no unacceptable toxicities. Responses will be~     assessed by clinical examinations every 4 weeks and MRI scans every 8 weeks.~   "
176944|NCT01249092|"~     Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive~     destruction of small bile ducts within the liver that can lead to end stage liver disease and~     all its complications.~      Although ursodeoxycholic acid (UDCA) is associated with increased survival in many patients~     with PBC, there is absence of an adequate response to UDCA in a significant proportion of PBC~     patients.~      Tumor necrosis factor alpha (TNF-alpha) is a cytokine that plays an important role in the~     pathogenesis of PBC. Other fibrosis biomarkers such as tissue metallo proteinase 1 (TIMP-1)~     are associated with progression of liver fibrosis in PBC. Pentoxifylline (PTX) is a~     methylxanthine derivative that inhibits pro-inflammatory cytokines and also has shown~     anti-fibrotic effects in serum of patients with PBC. Furthermore, PTX has well known clinical~     and safety profiles. The main hypothesis of this study is that therapy with pentoxifylline~     (PTX) will result in improvement of liver disease in PBC patients who are incomplete~     responders to UDCA.~      The focus of this proposal is on the effectiveness of PTX in improving laboratory parameters~     of liver disease and levels of cytokines involved in the pathogenesis of the disease in~     patients with PBC.~   "
176945|NCT01249079|"~     This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications~     that propose to enrich pre-existing resources for schizophrenia in the National Institute of~     Mental Health (NIMH) Human Genetics Initiative and to apply genomic methods to further the~     investigators understanding of the molecular etiology of the disorder. The overarching aims~     of this proposal are to quickly and cost-effectively ascertain a large sample of trio~     families affected by schizophrenia, and to discover causal variants for the disorder in the~     first family-based genome-wide association study (GWAS) of the disorder. In Taiwan, there is~     no such kind of policy to support this kind of GWAS study as it is a very expensive study,~     including collecting large family samples and genome-wide single-nucleotide polymorphism~     (SNP) scanning. The investigators, thus, collaborate with Professor Ming T, Tsuang and his~     entended subcontracted researchers to apply for this project. The investigators, the research~     team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia. Through~     additional ascertainment within this framework, the investigators will collect an aggregate~     sample with adequate power for detecting in a GWAS those variants that make even small~     contributions to the risk for the disorder.~      The investigators will meet the overarching goals of this project by accomplishing several~     Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese~     clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending~     all clinical data and biomaterials to the appropriate repositories; 3) Assess the association~     of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (SNPs) and their~     constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes such as age at onset~     ; 5) Perform a genome-wide survey for copy-number variations related to schizophrenia; 6)~     Test for gene-gene interactions (epistasis); and 7) Test for gene-environment interactions,~     such as the well-established effect of season of birth.~   "
176946|NCT01249066|"~     AMP-activated protein kinase (AMPK) is an evolutionally conserved protein kinase that serves~     as an energy guardian to help cells adapt to various metabolic stress including hypoxia.~     Because the role of AMPK in cancers has not been fully elucidated, in this study we~     investigated the expression and activation of AMPK in lung adenocarcinoma (LADC) cells and~     tissue.~   "
176947|NCT01249053|"~     Optic atrophy type 1(OPA1) is a nuclear dynamin-related GTPase, targeted to the inner~     mitochondrial membrane, which plays a role in mitochondrial fusion. Mitochondria fusion is~     associated with process of apoptosis. . OPA1 plays an important role in the mitochondrial~     bioenergetics and mitochondrial networks. The changes in mitochondrial shape and~     mitochondrial bioenergetics may be cause of the disease. In this study, we investigate the~     expression of OPA1 in lung adenocarcinoma (LADC) cells and tissue.~   "
176948|NCT01249040|"~     The purpose of this study is to investigate and compare different treatment programs for~     frozen shoulder by evaluating changes in pain scale and shoulder range of motion(ROM) before~     and after treatment.~      The investigators define frozen shoulder as shoulder pain with ROM limitation,shoulder~     arthrography demonstration of at least two of the following criteria:(1)reduced joint volume~     under 10ml; (2)irregular capsular margin;(3)diminished or absent axillary recess.~      Afer define diagnosis of frozen shoulder ,patients are randomly assigned to different~     Subgroups for different treatment programs.Each subgroup consists of ten patients.~      Each treatment program performed for 6 consecutive courses with each course consists of 6~     days.Total 36 treatment days.~      The treatment programs and grouping as follow:~      Group 1:Physical modalities + therapeutic exercise Group 2:Physical modalities + therapeutic~     exercise+ intra-articular injection of steroid Gouup 3:Therapeutic exercise Before~     treatment,after each consecutive course (6days) of treatment,and at the end of treatment~     program, the investigators evaluate the range of motion and muscle strength of shoulder~     flexion,external rotation,abduction and internal rotation. Severity of shoulder pain also~     evaluated by pain scale before and after treatment program.~      The ROM before and after treatment program is compared by paired t-test.The ROM change before~     and after treatment in different groups compared by analysis of variance(ANOVA). The ROM~     change after consecutive treatment courses(6 days) are compared by multivariate ANOVA.Pain~     scale before and after treatment is compared by paired t-test.~   "
176949|NCT01249027|"~     This is a prospective, observational, single-arm, open-label, multicenter, postapproval~     registry study in China. The purpose of this study is to:~        -  Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of~          real-world patients receiving the XIENCE V EECSS during commercial use~        -  Evaluate patient compliance to dual antiplatelet therapy (DAPT)~   "
177083|NCT01247272|"~     This study compared the relative bioavailability (rate and extent of absorption) of 90 mg~     Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC~     WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy~     adult volunteers under fasting conditions.~   "
176950|NCT01249014|"~     During surgery body temperature can decrease which can adversely affect how people recover~     from surgery. This is a common problem. We aim to reduce the incidence of this drop in body~     temperature during surgery by testing the effectiveness of two active body warming devices.~     One method is to warm the intravenous fluids that the patients will receive, as they are~     being infused. The other method is to use a forced-air warmer. This is a device that is~     similar to a blanket that the patient has laid over their upper body during the surgery which~     has warm air blown into it. The control group will not have any active warming methods. Study~     group 1 will have the intravenous fluid warmer in the pre- and intraoperative period.~      Study group 2 will have a forced-air warmer in the intra-operative period as well as the~     fluid warmer in the pre- and intraoperative period. We will also observe the neonates' vital~     signs following delivery.~   "
176951|NCT01249001|"~     The primary objective of this study is to compare the absorption of a prepared aprepitant~     oral suspension with that of the aprepitant capsule in children being treated with~     chemotherapy agents that are likely to cause vomiting.~   "
176952|NCT01248988|"~     The purpose of this study is to collect safety information following routine vaccination with~     Synflorix™ among infants in Korea.~   "
176953|NCT01248975|"~     The primary objective of this study is to evaluate the efficacy and safety of adding~     GSK2190915 300mg or placebo tablets administered once daily to fluticasone~     propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled~     asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.~      The secondary objectives are to undertake an exploratory analysis of the efficacy and safety~     of adding montelukast 10mg administered once daily to fluticasone propionate/salmeterol~     250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics~     and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 18 years of age~     over the course of 6 weeks treatment.~   "
176954|NCT01248962|"~     Patients who have this kind of cancer are often treated with several drugs. Carboplatin is~     one that seems to work for many treatment cycles. Even though it may work against the cancer,~     the patient can become allergic to it. If that happens, they would have to stop taking the~     drug. The standard way to give carboplatin is by vein over 30 minutes. The purpose of this~     study is to:~      Find out if giving carboplatin over three hours can prevent the allergy. See if medicine~     given before the carboplatin can help reduce the risk of allergic reactions.~      Some patients have been given carboplatin over 3 hours instead of 30 minutes. They had fewer~     allergies than we expected. We do not know if this was because of the way they got~     carboplatin or because of something else.~   "
176955|NCT01248949|"~     To determine the maximum tolerated dose or optimal biological dose, and the safety profile of~     MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in~     subjects with advanced solid malignancies resistant to standard therapy.~   "
176956|NCT01248936|"~     This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in~     patients who have received prior systemic therapy for metastatic melanoma and who have no~     other satisfactory treatment options.~   "
176957|NCT01248923|"~     This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma~     (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and~     bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF)~     support.~      This study has 2 parts. In the first part, patients will receive increasing doses of study~     drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF~     support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the~     highest dose of study drug possible that will not cause unacceptable side effects.~     Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting).~      In the second part of this study, patients will receive the best dose(s) and schedule(s) of~     study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first~     part of the study and will be followed to see what side effects the combination causes and~     what effectiveness the combination has, if any, in treating the cancer. Approximately 42~     patients from the US will be enrolled in Part 2 (Active, not recruiting).~   "
176958|NCT01248910|"~     Older people tend to live a sedentary lifestyle which causes a loss of cardiorespiratory~     fitness, impaired postural stability and a increased risk of falls. Social isolation of older~     people leads to depression and other mental diseases. However, numerous studies show that~     age-related degradation processes and functional limitations can be counteracted by physical~     activity. Various studies show that alpine skiing is a complex sport that places demands on~     the cardiorespiratory, neuromuscular and sensorimotor systems. With studies providing~     evidence to suggest alpine skiing is an appropriate activity for elderly as a~     health-enhancing sport, perhaps Alpine skiing could provide the physical activity needed to~     counteract age-related degradation processes and loss of function. To date, there is a lack~     of long-term intervention studies devoted to this topic. The aim of this study was to monitor~     the long-term effects of skiing on the health of older people, as to age-related muscle~     breakdown, cardiorespiratory fitness, body stability, general mobility and the overall~     psychological state of the subjects.~   "
176959|NCT01248897|"~     The purpose of this study is to understand how information of 3 specific biomarkers can~     provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.~   "
176960|NCT01248884|"~     This study is designed to evaluate the safety and immunogenicity of new formulations of GSK~     Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination~     course to healthy infants at 2, 3 and 4 months of age.~   "
176961|NCT01248871|"~     To compare the renal protective properties of two currently used anaesthetic techniques - a~     sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil~     combination for anaesthesia in patients undergoing living donor kidney~     donation/transplantation.~   "
176962|NCT01248858|"~     This is a Phase I, open-label, dose-escalation study to characterize the safety,~     tolerability, pharmacokinetic profile, pharmacodynamic profile, and clinical activity of the~     oral PI3K inhibitor GSK2126458 and the oral MEK inhibitor GSK1120212 dosed in combination in~     subjects with advanced solid tumors. The study will be conducted in 2 parts, a dose~     escalation phase and a tumor specific cohort expansion.~   "
177095|NCT01247116|"~     The purpose of this study is to evaluate the strategy of initiating double oral combination~     therapy with bosentan and sildenafil at the time of diagnosis of pulmonary arterial~     hypertension (PAH) in a preliminary way.~   "
176964|NCT01248832|"~     The study tested the effects of telephone counseling for smokers from three Asian language~     speaking groups: Chinese, Korean, and Vietnamese. The specific aims were to: 1) test the~     efficacy of a culturally appropriate counseling protocol for smokers calling the California~     Smokers' Helpline on the Chinese, Korean and Vietnamese lines, 2) examine whether~     intervention effects varied by cognitive and behavioral predictors of cessation success, 4)~     examine whether family involvement plays a role in quitting success, and 5) assess~     differences in counseling effect across the three ethnic groups.~   "
176965|NCT01248819|"~     Studies evaluating intraperitoneal local anesthetic instillation for pain relief after~     laparoscopic procedures have provided conflicting results. This randomized, double-blind~     study was designed to assess the effects of a novel intraperitoneal local anesthetic~     administration technique using nebulization on pain relief after laparoscopic~     cholecystectomy.~   "
176966|NCT01248806|"~     The purpose of this study is to offer annual low-dose spiral CT radiological examination for~     5 years to 5000 volunteers from the general population who are considered to be at high risk~     of developing lung cancer.~   "
176967|NCT01248793|"~     The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese~     patients with ankylosing spondylitis~   "
176968|NCT01248780|"~     The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese~     patients with rheumatoid arthritis.~   "
176969|NCT01248767|"~     This research aims to study the future of at risk or pathological gamblers seeking~     treatment at the University Hospital of Nantes. The study focuses on socio-demographic and~     clinical data. It notably aims to study the evolution of these variables according to the~     evolution of the gambling behaviours, the step of care, the modality of care, etc~   "
176970|NCT01248754|"~     The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade~     glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit~     neurosurgeons to achieve a complete resection more frequently.~   "
176971|NCT01248741|"~     High Dose Rate (HDR) temporary prostate brachytherapy offers a precise form of dose~     escalation for prostate cancer. Needles are placed, the position is confirmed and treatment~     is delivered. Previously High Dose Rate prostate brachytherapy was performed under~     TransRectal UltraSound (TRUS) guidance but planned with Computed Tomography (CT) imaging~     which introduced a source of error through needle displacement while transporting and~     repositioning patient. Recently Varian has introduced a one-step procedure where both implant~     and planning are based on UltraSound imaging and performed without patient repositioning.~     This planning system is approved by Health Canada and is commercially available.~      This study will use High Dose Rate brachytherapy to treat 15 men. Treatment will be planned~     with TransRectal UltraSound but validated pre-treatment using Computed Tomography imaging.~   "
176972|NCT01248728|"~     This is a pilot, randomized, placebo-controlled trial of omega-3 fatty acids in autism.~     Autism, originally described by Kanner in 1943, is among the most severe of~     neurodevelopmental disorders. It is a Pervasive Developmental Disorder (PDD) affecting social~     and communicative functions and is also characterized by repetitive behaviors/restricted~     interests. It is also frequently accompanied by significant aggression, self-injury,~     irritability and hyperactivity, making care for these individuals an even greater challenge~     for families or institutional settings. Autism severely impacts the affected individual and~     family members, causing life-long functional impairment. In this protocol the investigators~     will use the terms autism and autism spectrum disorder (ASD) interchangeably to refer to~     Autistic disorder, Asperger Syndrome and PDD-Not Otherwise Specified (NOS).~   "
176973|NCT01248715|"~     Current guidelines recommend early initiation of empiric antibiotic therapy to cover typical~     and atypical bacteria that may cause community-acquired pneumonia (CAP). Influenza antiviral~     therapy in patients with suspected or confirmed influenza. However, many clinicians do not~     suspect influenza among patients with CAP or other acute lower respiratory tract illness~     (LRTI) and often do not test for influenza. Additionally, results from currently available~     diagnostic tests for influenza may be delayed and several tests have low sensitivity and will~     give false negative results. Thus, anti-influenza treatment for patients with hospitalized~     influenza CAP and LRTI is frequently initiated late if at all. There is an association~     between delayed time to administration of empiric antibiotic therapy with increased clinical~     failure and mortality. As a result, empiric antibiotic therapy for patients with suspect CAP~     is begun within 4 - 6 hours of hospitalization. This has recently been demonstrated for~     delayed antiviral treatment as well. We hypothesize that, as happens with early empiric~     antibiotics for bacterial CAP, a standardized approach of adding early empiric anti-influenza~     therapy during the influenza season to hospitalized patients with suspect CAP and LRTI will~     improve clinical outcomes of patients with influenza associated CAP and LRTI.~      To test our hypothesis we plan a prospective, randomized, multicenter clinical trial of~     hospitalized patients with acute LRTI, including suspect CAP, during . If early~     anti-influenza medications were not included on the patients admission orders, patients will~     be randomized to standard care, including empiric antibacterial therapy as recommended by~     ATS/IDSA guidelines plus standard influenza diagnostics and treatment (Standard of care)~     versus early initiation of empiric antiinfluenza therapy plus standard care, e.g. empiric~     antibacterial (oseltamivir group). The primary study outcome will be development of clinical~     failure and selected clinical outcomes during the 30 days after enrollment. Other clinical~     outcomes that will be compared between study groups include time to clinical stability,~     duration of hospitalization, development of cardiovascular events, re-hospitalization,~     short-term mortality (30 days), and long-term mortality (1 year). The secondary study outcome~     will be the cost-effectiveness of the intervention.~   "
176974|NCT01248702|"~     The purpose of this study is to develop and implement a critical pathway to identify patients~     with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator~     (ICD). This study will also determine whether the use of the critical pathway for ICDs is~     associated with a change in the ICD referral and implantation rate.~   "
176975|NCT01248689|"~     One important goal in anesthetic management during ocular surgery is to provide adequate~     control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients~     with glaucoma or a penetrating open-eye injury. Accurate assessment of IOP is particularly~     important in infants and children with definite or suspected glaucoma undergoing examination~     under anesthesia.~      Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic~     agents, such as sevoflurane. Sevoflurane is known to reduce the IOP. During pediatric ocular~     surgery, the inspired sevoflurane concentration varies continuously and may have an impact~     over the IOP that could affect the conduct of surgery. In this study the investigators wish~     to evaluate whether variations in sevoflurane concentration do affect the IOP.~   "
176976|NCT01248676|"~     The purpose of this study is to determine if multi-language patients will find the~     multi-language capabilities of the online modules useful for better understanding of the~     general information regarding radiation therapy.~   "
176989|NCT01248494|"~     This is an open-label phase Ib multi-institution trial that evaluates the safety~     profile/tolerability and preliminary anti-tumor effect of BKM120 (a PI3K inhibitor) and~     endocrine therapy combination and BEZ235 (a PI3K/ mTOR inhibitor) and endocrine therapy~     combination in postmenopausal patients with hormone receptor-positive metastatic breast~     cancer.~   "
176977|NCT01248663|"~     Pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the~     pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater.~     For reconstruction, pylorus-preservation (PPPD) has been shown to be technically and~     oncologically equivalent to the traditional whipple operation. One issue with this technique~     is delayed gastric emptying (DGE), which occurs in 25-70% of patients, usually emerging~     between day 4 and 14 after surgery. Patients with severe DGE can not only experience~     prolonged length of hospital stay, but are also at increased risk for other complications~     like aspiration or other issues related to the inability to ingest nutrition.~      There is vast retrospective evidence and one prospective study indicating that antecolic~     reconstruction of the duodenojejunostomy can improve the rate and severity of delayed gastric~     emptying.~      The investigators have conducted a prospective randomized trial in order to test this~     hypothesis. Patients were randomized to either undergo antecolic or retrocolic reconstruction~     after PPPD. On day 10 after surgery, DGE was assessed by clinical criteria. In addition, a~     test meal including 1g paracetamol was administered to check for clinically inapparent DGE.~     Of these serum samples, kinetics of intestinal peptides like GLP-1, PYY and glucagon was alos~     measured.~   "
176978|NCT01248650|"~     The purpose of this study is to observe pharmacokinetics and safety of nalfurafine~     hydrochloride in patients receiving hemodialysis.~   "
176979|NCT01248637|"~     This study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken~     orally approximately 24 hours before surgical resection of a pancreatic tumor in order to~     identify areas of lower oxygen content on tumor samples.~   "
176980|NCT01248624|"~     Patients with advanced cancer often have numerous physical and psychological symptoms, which~     can negatively affect their quality of life. A palliative care team of different health care~     professionals (including doctors, nurses, social workers and therapists) specializes in~     treating these symptoms and offers support for patients and their families. However,~     palliative care teams are currently involved only in the last two months of a patient's life~     or not at all.~      The main purpose of this study is to determine whether, compared to conventional cancer care,~     early involvement by a specialized symptom control and palliative care team in patients with~     advanced cancer will be associated with: better quality of life, greater patient and~     caregiver satisfaction with care, better symptom control, improved communication with~     healthcare providers and improved caregiver quality of life.~   "
176981|NCT01248611|"~     Traditionally cancer pain is treated with long acting opioids such as morphine around the~     clock. However, there is no evidence that all patients have a stable pain requiring around~     the clock medication. So far opioids for self-administration with a rapid onset of action~     have not been available. Recently a nasal formulation of fentanyl (an opioid similar to~     morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable~     pain with short duration that breaks through the otherwise stable pain controlled with the~     around the clock medication. The basic idea is that this formulation may open for patient~     controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of~     nasally delivered fentanyl. This means that the patient only takes medication when in pain.~     This single center feasibility / safety study is the first part of a study to investigate~     this alternative cancer pain treatment approach.~   "
176982|NCT01248598|"~     The purpose of this study is to study the prevalence of EBV, HCMV, HHV-6 in saliva and on the~     toothbrush patient with periodontitis.~   "
176983|NCT01248585|"~     This research is being done because is is not known if dexamethasone can prevent pain flare~     (their pain temporarily gets worse before it gets better) caused by the radiation used to~     treat painful bone metastases. Using dexamethasone to prevent pain like this has been studied~     in a few people and seems promising, but it is not clear if it can decrease the pain or~     prevent the pain flare before it happens.~   "
176984|NCT01248572|"~     The primary goal of this study is to determine the effective lens position (ELP) - or~     location an intraocular lens (IOL) sits in the eye - of the Softec HD IOL. A secondary~     study goal is to determine if measures of the eye taken prior to surgery can reliably predict~     postoperative ELP.~   "
176985|NCT01248546|"~     The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include~     women aged 50 to 69 years invited to the population-based mammography-screening program. All~     women attending the screening unit will be asked if they want to attend the trial. If so,~     they will be informed about the project, the technique, and the additional compression and~     radiation dose. All mammographic examinations of women attending the trial will be~     independently interpreted by four radiologists. Since the trial is part of the official~     Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out~     on-line into the national screening database of the NBCSP. The study will include independent~     reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D~     plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all~     examinations having a positive score. Recalls and diagnostic work-up will be according to~     daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP.~      Outcome measures will use performance indicators for organized screening programs, including~     recall rate, false positive scores, cancer detection rate, positive predictive values, and~     cancer characteristics for the individual readers of the trial.~   "
176986|NCT01248533|"~     Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for~     abdominal aortic aneurysm.~   "
176987|NCT01248520|"~     A randomized, controlled clinical trial to assess whether text messaging to an outpatient~     obstetric population can improve maternal influenza vaccine uptake.~   "
176988|NCT01248507|"~     COPD patients frequently suffer intermittent exacerbations of their disease characterised by~     acute deterioration of symptoms. Acute exacerbations of COPD (AECOPD) are associated with~     significant impairment of health status, use of health care resources, poor prognosis and~     increased mortality. The development of simple and practical predictive tools would help to~     identify COPD patients at greater risk of suffering exacerbations, which is important since~     those patients would need more intense and early treatment.~      This one-year prospective cohort non-drug study will evaluate several COPD-specific~     questionnaires as predictive tools and the presence of cardiovascular comorbidities as risk~     factors, for the composite events in study cohorts. The trial duration consists of a~     screening period (4-6 weeks) and a follow-up period (12 months), 4 visits in total along the~     study.~   "
176992|NCT01248455|"~     Background:~        -  Recent studies have shown that smoldering multiple myeloma has a high risk of~          progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5~          years of diagnosis. People with smoldering multiple myeloma have abnormal blood test~          results that show a high level of monoclonal protein (M-protein) in the blood and of~          plasma cells in the bone marrow. There are currently no known effective treatments to~          prevent smoldering multiple myeloma from developing into multiple myeloma, and there are~          no known tests for determining whether an individual with smoldering multiple myeloma~          will develop multiple myeloma.~        -  Certain cells in the immune system, known as natural killer (NK) cells, are active~          against multiple myeloma. The experimental drug anti-killer cell immunoglobulin-like~          receptor (anti-KIR) has been shown to help NK cells kill multiple myeloma cells.~          Researchers are interested in determining whether anti-KIR can be given to individuals~          with smoldering multiple myeloma to improve their abnormal blood test results.~      Objectives:~      - To evaluate the safety and effectiveness of anti-KIR as a treatment for abnormal blood test~     results related to smoldering multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with smoldering multiple~     myeloma.~      Design:~        -  Participants will be screened with a physical examination and medical history, and will~          provide baseline blood, urine, and bone marrow samples before beginning the study drug.~        -  Participants will receive anti-KIR intravenously for 1 hour, and will be closely~          monitored for 24 hours after receiving the first dose. If there are no serious side~          effects, participants will receive five additional anti-KIR doses, one every other~          month, for a total of six treatment cycles.~        -  Participants will have monthly visits to provide additional blood and urine samples, and~          may have additional bone marrow biopsies as directed by the study researchers.~        -  Participants will have followup visits every 3 to 6 months for up to 5 years after~          receiving anti-KIR treatment.~   "
176993|NCT01248442|"~     In this placebo controlled study the investigators aim to investigate the effect of a 3 month~     vitamin D supplementation on parameters of the immune, endocrine and metabolic system in~     healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of~     certain immune cells, which regulate immunotolerance, the investigators therefore try to~     confirm these results with a placebo group. Furthermore the investigators assess the effect~     of vitamin D on the glucose metabolism and hormone levels.~   "
176994|NCT01248429|"~     This study describes the elevation of CPK in patient treated for solid tumors by TKI~   "
176995|NCT01248416|"~     When treating very short children in puberty we are time-limited, as sex hormones cause the~     growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty,~     increase height potential, but leave children sexually infantile at a critical time in~     development. Human and animal data show that estrogen, in females and males, is a principal~     regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs),~     which block testosterone to estrogen conversion, in boys with different growth disorders, we~     have shown that AIs may have beneficial effects enhancing height potential in growth-retarded~     males, without affecting their puberty. However, no direct comparison of the effect of AIs~     alone vs. conventional GH treatment has been done to date. This study will assess the effect~     of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent~     boys with idiopathic short stature.~   "
176996|NCT01248403|"~     Adult patients with gastric carcinoma which has progressed after initial treatment with a~     fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus~     placebo. The hypothesis is that patients with RAD001 have significantly prolonged overall~     survival compared to patients who are treated with paclitaxel alone.~   "
176997|NCT01248390|"~     The purpose of this research is to see whether adding a new therapy helps people with brain~     injury focus better and think more clearly. You are being asked to participate in this~     research study because you have had a brain injury. If you decide to volunteer, you will be~     in the study for about six months.As a participant, you will be randomly assigned to one of 2~     treatment plans. Randomization is a process like flipping a coin and means you will have a~     chance of being assigned to either of the plans. One group will be given an experimental~     therapy using a metronome one hour a day, three times a week. A metronome is a device that~     produces a steady beat. You will need to keep time with the metronome doing several different~     movements. On each beat, you will be given information both through sound and on a computer~     screen about whether you were early or late and how far off beat you were. The tempo of the~     beat will be at 54 beats per minute, so you will need to process the feedback information~     very quickly to adjust your speed up or down to match the beat. The various movements include~     things like clapping hands, tapping toes, or alternating between different similar movements.~     It is hoped that the metronome will help subjects to concentrate better.~   "
176998|NCT01248377|"~     This study aims to compare the results of skin testing and ELISPOT assay in patients with a~     history of non-immediate reactions to cephalosporins~   "
176999|NCT01248364|"~     An open-label, phase II study to assess the acute and chronic effects of empagliflozin (BI~     10773)on fasting and postprandial glucose homeostasis in patients with IGT and type 2~     diabetes mellitus and assess the acute effects of empagliflozin in healthy subjects.~   "
177000|NCT01248351|"~     The objective of the study is to test the hypothesis whether or not autologous stored~     platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed~     by state-of-the-art platelet function assays.~   "
177001|NCT01248338|"~     An impairment of endothelial function plays the central role in the pathogenesis of~     cardiovascular diseases and their complications. Most of cardiovascular risk factors are~     known to impair endothelial function and the established disease further aggravates~     endothelial dysfunction.~      The aim of the present study is to investigate the effects of nebivolol or metoprolol~     succinate on endothelial function and large artery stiffness.~   "
177002|NCT01248325|"~     Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1~     ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL,~     Group B: saline).~      The subjects will use the study medication or comparative, according to their randomization,~     for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after~     initiation of treatment.~   "
177003|NCT01248312|"~     Hypercapnea is a condition where there is too much carbon dioxide (CO2) in the blood. Carbon~     dioxide is a gaseous product of the body's metabolism and is normally expelled through the~     lungs (breathed out). Hypoventilation (or respiratory depression) occurs when the ventilation~     is inadequate to perform needed gas exchange; therefore resulting in decreased levels of~     oxygen and increased levels of carbon dioxide in the blood. It can cause an increased~     concentration of carbon dioxide and respiratory acidosis. Obesity is a multi-system disorder,~     particularly involving the respiratory (lungs/breathing) and cardiovascular (heart/vessel)~     systems. Obesity increases the risks for surgical and anesthetic complications before, during~     and following surgery.~      Bariatric (weight loss) surgery is becoming a common procedure among the morbidly obese (100~     lbs or more above normal weight), with recent studies highlighting the long-term health~     implications of surgical weight reduction, to include a decreased risk of hypertension (high~     blood pressure) and diabetes (increased sugar in blood). Obese patients are at increased risk~     of sleep apnea (stop breathing while asleep) and hypoventilation even without surgery, and~     these risks increase following administration of medications typically given during and after~     major surgical procedures. Hypoventilation can lead to hypercapnea, sedation (sleepiness),~     and acidosis (blood imbalance), resulting in further respiratory compromise (breathing~     problems) and cardiac morbidity (heart problems) as well as the risks inherent in~     re-intubating (needing to have a breathing tube place down into the lungs) the~     obese.Monitoring for hypoventilation can be difficult. Quantitative capnography (measuring~     carbon dioxide) is only appropriate for intubated patients (on a ventilator - breathing~     tube), and pulse oximetry (clip on finger that measures oxygen levels) does not adequately~     detect hypoventilation in patients receiving supplemental (additional) oxygen. Serial~     arterial blood gas (blood taken from an artery to measure oxygen level in blood) measurement~     is expensive, time-consuming, and painful. Continuous respiratory rate monitoring is~     possible, and has been considered the gold standard of apnea detection (seeing stopped~     breathing), yet is seldom used. As a result of these limitations, there is currently no~     simple, cost-effective, and reliable means of detecting hypoventilation in this patient~     population either in the recovery room or inpatient unit. Transcutaneous (across the skin)~     pCO2 (t-pCO2) monitoring has been validated as a reliable and reproducible means of measuring~     pCO2 in newborn babies, and recently has also been used in adults, primarily in the ICU~     (intensive care unit) setting. When compared to standard end-tidal CO2 measurement, t-pCO2~     correlates better with pCO2 in the intraoperative period in both thin and obese patients.~     SenTec, is the manufacturer of a device used to measure t-pCO2 for this project. This study~     is designed to detect the incidence of hypercapnea in morbidly obese post-surgical bariatric~     patients in the postoperative period using the SenTec t-pCO2 monitor.~      Objective:To determine the incidence of hypoventilation and hypercapnea as measured by~     transcutaneous pCO2 monitoring in post-surgical bariatric patients as compared to thin~     controls.~   "
177004|NCT01248299|"~     Interest of continuing systemic chemotherapy or not , after a short initial treatment (6~     weeks) in patients who are in response or stable disease(Discontinuation design )of~     patients with metastatic oesophageal cancer of squamous cell type~      The secondary aims would be to study : toxicity, the overall survival rate, a study of costs~     and quality of life.~   "
177014|NCT01248169|"~     The utilization of external cardiohemodynamic patient assessment, applying non-invasive~     stick-on contact patches to the mother's neck on either side and chest wall on either side,~     enables the practitioner to have information about the patient's cardiac function and~     vascular status beyond simply blood pressure and pulse. This information, once collected,~     should open the practitioner's eyes to better assess the patient's disease status and her~     response to therapy. We will use this information to compare the effectiveness of the two~     standard medications used for treatment of maternal high blood pressure.~   "
177005|NCT01248286|"~     Food products derived from cereal grains constitute a major part of the daily diet of many~     Americans . For example, a typical Chinese American eats rice about 9.5 times a week on an~     average. However, most of these foods are derived from refined grain. During the refining~     process grains are stripped of their bran and germ which results in depletion of several~     biologically active constituents including fiber, anti-oxidants, phytoestrogens and minerals.~     From observational studies there is evidence for a protective effect of whole-grain foods~     with regard to the development of type 2 diabetes. More recently, higher intake of whole~     grains was also associated with decreases in insulin resistance - a risk factor related to~     the development of type 2 diabetes.~      In this randomized study the investigators plan to replicate this beneficial effect of~     improving insulin sensitivity in patients with pre-diabetes and go a step further by~     exploring the potential mechanisms by which this benefit may occur. The investigators will~     assess the effect of consuming a whole-grain-rich diet on levels of advanced glycation~     endproducts (AGE), RAGE (receptor for AGE) and markers of inflammation and oxidative stress -~     all of which have been shown to play an important role in the pathogenesis of diabetes~     mellitus. The investigators will also look for correlations between the levels of these~     markers with insulin sensitivity to identify potential mechanisms of pathogenesis.~   "
177006|NCT01248273|"~     The purpose of this study is to 1) test the safety of the vaccine to find out what effects,~     good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The~     vaccine in this study will contain several parts. The first part is called an antigen. These~     antigens or fingerprints are found on many cancer cells, especially from the ovaries,~     fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this~     study is to see if investigators can help the immune system to recognize that cancer cells~     are not normal and should be removed.~   "
177007|NCT01248260|"~     The purpose of this study is to find out if folic acid prevents of the reduction of fetal~     body and brain size in infants whose mothers smoke.~   "
177008|NCT01248247|"~     Different people have different biomarkers (chemical markers in the blood that may be~     related to your reaction to study drugs). If researchers know about your biomarkers before~     you receive treatment, they may be able to prescribe a treatment that is better suited to~     your body's specific needs.~      The goal of this clinical research study is to learn if drug or drug combinations based on~     your biomarkers can help to control NSCLC. The safety of these drug combinations will also be~     studied.~   "
177009|NCT01248234|"~     This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide~     a more stable blood pressure when used to put elderly hypertensive patients to sleep than~     either drug used alone.~   "
177010|NCT01248221|"~     The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath~     test and scintigraphy in healthy subjects and subjects with dyspepsia.~      Subjects will eat a standard meal of 2 scrambled eggs, a slice of wheat toast and 8 ounces of~     skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and~     13C-Spirulina platensis.~      Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body~     tissue is produced through the detection of radiation emitted by a radioactive substance~     administered into the body. The location of a standard meal in the digestive system will be~     measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after~     the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical~     diagnostic procedures.~      Spirulina platensis is blue - green algae, which is very similar to the naturally occurring~     spirulina sold in health food stores as a dietary supplement. The spirulina platensis has~     been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as~     1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will~     be measured by breath samples at periodic intervals before and after a standard meal. The FDA~     considers 13C-Spirulina platensis to be investigational for the purposes of this study.~   "
177011|NCT01248208|"~     With the growing public health concerns of seasonal influenza and H1N1 in the United States,~     the primary means by which this can be addressed is with prevention, namely, vaccination~     against the influenza virus. The only individuals not able to receive this vaccination in the~     primary care provider's office are those patients with egg allergies and, in rare~     circumstances, individuals with allergies to other components of the vaccine. Current~     guidelines allow for the administration of the influenza vaccine to patients with egg allergy~     using vaccines with low egg protein (ovalbumin) content or by using skin testing followed by~     a 5-dose desensitization protocol. Since this is impractical to perform in the primary care~     office and cumbersome for allergists, many egg-allergic patients simply do not receive the~     influenza vaccine, leaving them more vulnerable to the disease and more likely to become a~     source of contagion.~      Several studies have suggested that influenza vaccination using a 1-2 dose protocol may be~     safe. This fact is due in large part to the low ovalbumin (egg protein) content in modern~     influenza vaccines. All studies of influenza vaccination in egg-allergic patients have been~     done using intramuscular trivalent inactivated influenza vaccine (TIV). However, the~     trivalent live-attenuated, cold-adapted influenza vaccine (LAIV), which is delivered~     intranasally, has a lower published ovalbumin content than the injectable vaccines,~     suggesting that it may also be well-tolerated by egg-allergic patients. According to several~     studies, LAIV may be more efficacious than TIV in children.~      It is the goal of the investigators to evaluate the safety of immunizing egg-allergic~     individuals with the LAIV.~   "
177012|NCT01248195|"~     The purpose of the study is optimising current treatments in schizophrenia and explore novel~     therapeutic options for schizophrenia. The study intends to both address basic, but so far~     unanswered, questions in the treatment of schizophrenia and develop new interventions. It is~     expected that the project will lead to evidence that is directly applicable to treatment~     guidelines, and will identify potential mechanisms for new drug development.~   "
177013|NCT01248182|"~     The purpose of this study is to determine the bone to skin depth for groups of lean, obese~     and morbidly obese patients. This information will be potentially helpful with implant design~     for obese and lean patients.~   "
177096|NCT01247103|"~     The purpose of the study is to assess the safety, tolerability and pharmacokinetics of~     AZD4316 following oral administration of single and multiple doses to healthy volunteers.~   "
177015|NCT01248156|"~     Atrial fibrillation (AF) is the most prevalent heart rhythm disorder in the United States,~     affecting 2.5 million individuals in whom it may cause stroke, palpitations, heart failure,~     and even death. Unfortunately, therapy for AF is limited. Anti-arrhythmic or rate-controlling~     drugs are poorly tolerated, with frequent side effects and do not reduce stroke risk.~     Ablation is an emerging, minimally invasive therapy that has attracted considerable attention~     because it may eliminate AF. Unfortunately, AF ablation is technically challenging, with a~     success of only 50-70% (versus >90% for other arrhythmias) and serious risks. A major cause~     of these limitations is that the mechanisms for human AF are not known and thus ablation~     cannot be directed to them. As a result, AF ablation is empiric and results in extensive~     destruction of the atrium.~      This project will perform research to better understand AF and determine if abnormal activity~     in small regions or more widespread regions of the heart cause AF. By performing these~     studies in patients during clinical procedures, this project may lead to a paradigm shift in~     the understanding and treatment of AF.~   "
177016|NCT01248143|"~     Type 2 diabetes is common in ethnic and, minority groups in developing and developed~     countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and~     Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya~     preparation and green tea infusates in latent diabetes (individuals newly diagnosed as~     diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically~     modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation~     end-products which play a role as proinflammatory mediators in gestational diabetes can~     accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction~     with high-affinity receptors located on monocytes and macrophages can enhance the production~     of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis~     factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial,~     mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of~     cardiovascular complications. The clinical markers include C-reactive proteins (inflammation~     indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides,~     and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides, total~     cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated~     protein C affects the permeability of the glomerular capillary wall and enhances apoptosis of~     glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology of~     diabetic nephropathy. A second phase of the study is expected to commence after the first 16~     weeks in order to assess the ability of the dietary factors to modulate atheroma formation~     and the integrity of drug therapy (upon commencement of treatment)on the prognosis of~     diabetes. This will be expected to last up to 3 years.~   "
177017|NCT01248130|"~     The primary aim of this study is to examine the efficacy and tolerability of short-term~     omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The~     investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core~     and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be~     safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the~     neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The~     investigators hypothesize that omega-3 fatty acids will be efficacious in improving cognitive~     functions in youth with ASD.~   "
177018|NCT01248117|"~     Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal~     choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved~     anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.~   "
177019|NCT01248104|"~     We hypothesize that tranexamic acid administration will be associated with 25% improvement in~     the volume of blood loss and red blood cell (RBC) administration, with no increase or a~     decrease in perioperative complications~   "
177020|NCT01248091|"~     Increasing accessibility of long-acting reversible contraceptive methods, like intrauterine~     devices (IUDs), is an important strategy to reduce the risk of unintended pregnancy.~     Unfortunately, fear of IUD insertion in women who have not had children is common among~     health care providers and women alike, and this limits IUD use. To increase acceptance of~     this highly effective contraceptive, there is need to investigate novel, low cost, easily~     applied and accessible techniques to improve the insertion experience. This is a pilot study~     to evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an~     intervention to improve the IUD insertion experience for both patient and provider.~   "
177021|NCT01248078|"~     In this prospective, randomized, placebo controlled trial the investigators were able to~     demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus~     placebo, irrespective of the timing of administration, ie before skin incision or after~     umbilical cord clamping~   "
177022|NCT01248065|"~     The purpose of the study is to find out if taking vitamin D in addition to an asthma~     controller medication helps to prevent worsening of asthma symptoms and asthma attacks.~   "
177023|NCT01248052|"~     This is a two part study (Parts A and B), the purpose of which is to determine the safety of~     LY2979165 in healthy people, and any side effects that might be associated with it, and to~     understand how the body handles LY2979165. In addition, Part B, will also look at levels of~     LY2979165 in spinal fluid. Doses investigated will be in the range of 20-1000 mg.~   "
177024|NCT01248039|"~     This study wish to show if the preoperative level of pain, function or activity for hip and~     knee arthroplasty patients has any predictive value of the time it takes to fulfill the~     well-defined discharge criteria.~   "
177025|NCT01248026|"~     The role of low-density lipoprotein cholesterol (LDL-C) in the pathogenesis of cardiovascular~     disease (CVD) and the clinical benefit of lowering LDL-C in high-risk patients have both been~     well established. The key contribution of the intestine to whole body cholesterol homeostasis~     and thus to regulating plasma cholesterol concentrations has also been recognized over the~     last years. It is now clear that cholesterol homeostasis and hence plasma LDL-C~     concentrations are maintained by a fine-tuned balance between intestinal cholesterol~     absorption and endogenous cholesterol synthesis.~      Cholesterol is a highly hydrophobic molecule and for that reason, its absorption is almost~     entirely dependent on its solubilizing capacity in bile acid micelles within the intestine.~     Recent in vitro studies from our laboratory have shown that buttermilk, a unique by-product~     of butter manufacturing resulting from the churning of cream, has a strong inhibitory effect~     on cholesterol micelle solubility. This phenomenon is likely due to the presence of unique~     milk fat globule membrane (MFGM) fragments present in buttermilk that are produced during the~     manufacturing of dairy cream into butter. Most of the work done so far on the subject has~     focused on phospholipids purified from MFGM, while overlooking the complex and entire MFGM~     mixture of bioactive proteins and polar lipids found in buttermilk. To the best of our~     knowledge, no study has yet documented the impact of whole buttermilk on plasma cholesterol~     concentration in human.~      The general objective of this research project is to investigate for the first time the~     impact of buttermilk on plasma cholesterol and other risk factors for CVD in humans. More~     specifically, we propose to investigate the impact of buttermilk consumption on plasma LDL-C~     and other CVD risk factors as well as on plasma surrogates of cholesterol absorption and~     synthesis.~   "
177026|NCT01248013|"~     The primary goal of the study was whether gut focused hypnotherapy, in a group format, was~     successful in reduction of symptoms in patients with irritable bowel syndrome. The secondary~     goal was to see if any outcome predictors could be determined.~   "
177027|NCT01248000|"~     Positron Emission Tomography (PET) represents a step forward in the definition of response to~     therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early~     assessment of response has been described as the most important tool for predicting the risk~     of disease progression. As no data are available to support the use of early assessment of~     response for adapting and modifying subsequent treatment, the use of PET should be limited~     only to patients enrolled in clinical trials. Irrespective of recommendations PET scanning is~     included in the current management of patients with HL at baseline, mid treatment, end of~     treatment, and follow-up. So far no study has been performed to verify how PET is currently~     used in the clinical setting and to assess if and how results of PET scanning are used for~     supporting treatment and clinical decisions.~   "
177028|NCT01247987|"~     The purpose of this study is to determine if cryopreservation at the blastocyst stage~     followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear~     oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. Effectiveness~     will be measured by the rate of ongoing pregnancy at 10 weeks gestation.~   "
177029|NCT01247974|"~     This is a multi-center, prospective, randomized and controlled clinical trial comparing the~     safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of~     new onset postoperative atrial fibrillation by circumferentially reconstructing the normal~     pericardial anatomy following isolated, first-time, CABG procedures compared to subjects that~     do not undergo pericardial closure. This trial will be conducted at up to 20 clinical sites~     in the U.S.~   "
177030|NCT01247961|"~     This pilot trial will evaluate the following in patients with acute pancreatitis:~        1. Safety profile of early treatment with intravenous dexamethasone~        2. Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis~        3. Provide preliminary data on potential impact of early treatment with steroids on~          clinical outcomes~   "
177031|NCT01247948|"~     The purpose of this study is to investigate the difference of the accuracy and safety between~     traditional spine surgery and computer assisted navigation system spine surgery.~   "
177032|NCT01247935|"~     To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation~     (TENS) in reducing patient's discomfort during colonoscopy~   "
177033|NCT01247922|"~     Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205~     and either progressed while on study or discontinued due to unacceptable toxicity related to~     etoposide were allowed to participate in this study to assess the safety profile of~     single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.~   "
177034|NCT01247909|"~     This study aims to improve the outcome of infants (<2 months) with severe sepsis and~     meningitis at the Queen Elizabeth Central Hospital, Blantyre, Malawi.~      Currently WHO recommends the treatment of infant severe sepsis and bacterial meningitis with~     14 to 21 day course of penicillin and gentamicin as first line. The second line treatment is~     cefotaxime or ceftriaxone.~      Severe bacterial infections are common in infants under 2 months of age and the mortality is~     very high (~50%). There are several reasons for this; one is that the first line antibiotics~     used are no longer as effective as they used to be. Bacterial resistance to the first line~     antibiotics has increased and some infections especially of the central nervous system may~     only be partly treated and not eradicated by present therapy. First line treatment is cheap~     and available but requires 4 injections a day, for at least 14 days, a total of 58~     injections. Many mothers find this number too much and abscond. The investigators second line~     therapy is ceftriaxone which is also available and cheap and the advantage of being given as~     a daily injection. The disadvantage is that it can cause (reversible) jaundice particularly~     in premature babies and it must not be given with calcium products. The investigators do not~     give calcium to the investigators infants as the investigators cannot routinely check~     electrolytes. All the most common causes of bacterial meningitis in this age group in the~     investigators setting are sensitive to ceftriaxone.~      The investigators wish to undertake an open randomized trial of penicillin and gentamicin v~     ceftriaxone as first line treatment for infant meningitis. The investigators are able to~     monitor for side effects.~      The investigators hypothesise that the ceftriaxone arm will have 20% less deaths that the~     penicillin and gentamicin group.~   "
177035|NCT01247896|"~     PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The~     purpose of the study is to evaluate the safety and tolerability of PF-05190457 after~     administration of a single dose to healthy volunteers and to evaluate the plasma drug~     concentrations after single dose in healthy volunteers.~   "
177036|NCT01247883|"~     This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when~     respectively given orally as a single tablet dose and a single dose of a solution.~   "
177037|NCT01247870|"~     The purpose of this study is to determine the effect of a tablet medication, called~     metformin, in flare-ups (exacerbations) of chronic obstructive pulmonary disease. The~     investigators believe that metformin may effectively control the blood sugar level during~     COPD exacerbations. This is important because there is evidence that a high blood sugar level~     during exacerbations may be linked with a worse prognosis. The investigators also think that~     metformin may have other potentially useful effects on inflammation, antioxidant levels, the~     effectiveness of steroid treatment, and recovery.~   "
177038|NCT01247857|"~     Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after~     laparoscopy. Preoperative compared with postoperative administration of analgesia remains~     controversial. This randomized, double blind, placebo-controlled trial compared the analgesic~     efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients~     undergoing elective laparoscopic cholecystectomy.~   "
177076|NCT01247363|"~     Safety study with multiple oral doses of LY2608204 given to patients with type 2 diabetes.~     Study subjects will receive once daily doses of LY2608204 for a total treatment duration of~     up to 28 days. In this study, each patient will receive increasing doses of LY2608204 until~     reaching the highest dose that they can tolerate.~      Continuous glucose monitoring devices will be employed for each patient to monitor for~     hypoglycemia during study treatment. Dose titration and dose reduction is determined for each~     individual patient based on their safety and glycemic data.~   "
177077|NCT01247350|"~     To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple~     doses in Japanese healthy subjects.~   "
177039|NCT01247844|"~     The objective of this research study is to evaluate the safety and acceptability of the Shang~     Ring method of medical male circumcision. The Shang Ring is a new circumcision device with a~     potential role in the safe and cost-effective delivery of circumcision services. The device,~     developed in China, consists of two concentric plastic rings. Following a ring penile block,~     the smaller ring is fitted at the base of the coronal sulcus. The foreskin is everted over~     the inner ring and the larger outer ring is secured over the inner ring. The foreskin is~     excised and several nicks are made on the incision line to prevent formation of a~     constricting, circumferential scab. No suturing is required.~      In this study, the investigators will evaluate wound healing of men randomized to removal of~     the Shang Ring at one of three different points in time (Days 7, 14 or 21). Leaving the~     device on for 14 or 21 days constitutes extended wear of the device.~      Sites: Homa Bay District Hospital, Nyanza Province, Kenya~   "
177040|NCT01247831|"~     The purpose of this study is to examine the influence of selective laser trabeculoplasty~     (SLT) on ocular rigidity in glaucoma patients.~   "
177041|NCT01247818|"~     PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical~     administration to the skin, and is being studied for the treatment of cutaneous skin~     disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of~     subjects randomized sequentially by center to one of four treatment cohorts will assess~     efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque~     psoriasis.~   "
177042|NCT01247805|"~     The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10~     Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil~     Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet~     in Healthy Volunteers.~   "
177043|NCT01247792|"~     The care of patients with sepsis-related organ failure on the intensive care unit (ICU) often~     includes end-of-life decision (EOL-D) and communication of such decisions to relatives. This~     increases the psychological burden for caregiver and relatives.~      The investigators intend to assess the prevalence and impact of EOL-D on ICU care-givers and~     relatives (before) and to use this data to develop and implement standard operating~     procedures (SOPs) for improved decision-making and communication of these decisions~     (after).~      The hypothesis is that an improved communication strategy will reduce symptoms of burnout in~     caregivers and symptoms of anxiety and depression in relatives.~   "
177044|NCT01247779|"~     The purpose of this study is to compare perioperative morbidity of coelioscopy versus~     robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.~   "
177045|NCT01247766|"~     The purpose of this study is to compare the incidence rates of infection, malignancy and~     death among patients with rheumatoid arthritis who are treated with abatacept and those who~     are treated with other anti-rheumatic medications for rheumatoid arthritis.~   "
177046|NCT01247753|"~     The prevalence of Gestational Diabetes Mellitus (GDM) in Australia is approximately 5%-8%,~     with up to one third of all parous women who develop type 2 diabetes having a previous~     history of GDM. Research to determine strategies to delay or prevent the development of or~     progression to diabetes is vital, particularly in population groups that are at higher risk,~     such as GDM, and overweight women (BMI>=25). Currently, follow-up or post-partum support for~     women who develop GDM is limited to advice to complete a 6 week post-partum oral glucose~     tolerance test to exclude overt diabetes, to be repeated annually. A pilot randomized~     controlled trial (RCT) conducted at Mater Mothers Hospital suggested that a post-partum~     intervention designed to increase physical activity in women with previous GDM may be~     feasible. A recent study in the United States recruited women with recent GDM into an RCT~     where the control group received usual care and the intervention group received a web based~     walking program. Although the results of this study are limited, they did show an increase in~     pedometer steps/day between baseline and end of study. Dietary intervention has been proven~     to increase probability of weight loss, so a strategy of combining both a pedometer and~     nutrition based program may prove to be more successful for long term improvement of a~     healthy lifestyle to prevent type 2 diabetes.~      Study hypothesis: A pedometer based intervention to encourage physical activity, combined~     with nutrition coaching in women with recent GDM and BMI >= 25 will result in increased~     weight loss, improved insulin sensitivity and increased physical activity when compared with~     standard care.~   "
177047|NCT01247740|"~     The purpose of the study is to investigate the efficacy and safety of a convenient~     3-chamber-bag containing aminoacids, glucose and lipid emulsion (LCT/MCT 20%) compared to a~     conventionally compounded monobag for parenteral nutrition.~   "
177048|NCT01247727|"~     National Taiwan University Hospital is the leading center for care of patients with~     extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes~     are still lacking in patients with the ECMO support. The aim of this study is to collect the~     electrical signals stored in the monitor of intensive care units (ICUs), which are analyzed~     by the bio-informatics software. The pre-, peri-, and post-ECMO heart rate variability,~     including linear and non-linear analysis is calculated to address the association with~     outcomes of patients with ECMO. In addition, we collected the demographics, body temperature,~     respiratory rate, and blood pressure to investigate the causes of heart rate variability.~   "
177049|NCT01247714|"~     The hypothesis of the proposed trials is that the regular intake of a specific diet designed~     for enteral nutrition of type 2 diabetic patients results into a better nutritional status.~     Thus, the aim of the study is to scientifically evaluate the healthy effects of the~     administration of an enteral complete diet for diabetic patients (T-Diet plus Diabet).~   "
177078|NCT01247337|"~     A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in~     combination with systemic gemcitabine and capecitabine in combination with cetuximab in~     patient with non-resectable liver metastases from cholangiocarcinoma.~   "
177130|NCT01246661|"~     The purpose of this study is to evaluate if the UpSpring Milkscreen Alcohol Test works to~     detect alcohol in breast milk that will be donated during this study. This research is being~     done because the sponsoring company, UpSpring, wants to determine if this test will work and,~     if it does, how well it will work to detect levels of alcohol in breast milk.~   "
177288|NCT01244555|"~     The purpose of this study is to determine the effectiveness of treatments (massage therapy or~     ultrasound) directed at skeletal muscle for alleviating pain associated wtih tension~     headache.~   "
177050|NCT01247701|"~     In this study, the investigators will use busulfan and cyclophosphamide (BuCy) backbone with~     the addition of fludarabine as the preparative Stem Cell Transplant (SCT) regimen. As an~     attempt to improve engraftment rate and reduce infections, the investigators are going to~     incorporate fludarabine in the conditioning regimen. The use of a BuCy backbone has been~     widely used and comparable to total body irradiation and cyclophosphamide (Cy/TBI) regimen.~      Encouraging data on adding fludarabine to the SCT regimen have been reported. A~     fludarabine-based, conditioning regimen, with adequate immunosuppressive activity could~     conceivably allow engraftment of stem cells from alternative donors in hematologic~     malignancies patients with acceptable engraftment rates and low transplant-related mortality.~     Regimen-related toxicity is believed to be a major contributing factor to GVHD. Therefore~     this approach may also lead to reduced GVHD, as some investigators have suggested.~      In an attempt to decrease the rate of viral infection and reactivation, the investigators~     will avoid ATG (Thymoglobulin) / Campath (anti-CD52), and instead administer Mycophenolate~     Mofetil (MMF). The addition of fludarabine should compensate any increase risk of graft~     failure with the removal of the ATG/Campath. The investigators anticipate that the removal of~     ATG/Campath will facilitate immune reconstitution more efficiently after receiving a UCBT.~   "
177051|NCT01247688|"~     The purpose of this study is to determine the safety and effectiveness of UCBT to treat~     patients with lymphoid hematological diseases and to see if this treatment can decrease the~     incidence of leukemia relapse, GVHD and infections.~      These patients have a type of blood cell disorder that is very hard to cure. This treatment~     that is being used in this trial is known as a stem cell transplant. This treatment might~     help the patient live longer without the disease. It uses much stronger doses of drugs and~     radiation to kill the diseased cells that could be given without the transplant. We also~     think that the healthy cells from the donor may help fight any diseased cells left after the~     transplant.~      For the transplant to take place, we will administer stem cells from a 'donor' whose cells~     best 'match' the patient's. In this study umbilical cords will be the source of the stem~     cells. Before the transplant, two very strong drugs plus total body irradiation will be given~     to as preconditioning. This treatment will kill most of your blood-forming cells in the bone~     marrow. The patient will then get then healthy stem cells.~      If the patient has the disease in the central nervous system (CNS), they will receive~     radiation to the head and spine before starting the conditioning. This is to try to get~     disease control in the CNS. Radiation will not be given for children under 2 yrs old.~      Currently, many umbilical cord blood units are available in public banks for transplantation~     in patients lacking bone marrow donors. UCB transplants (UCBT) may offer several advantages~     over adult bone marrow or peripheral blood stem cell transplants, including:~        1. rapid availability,~        2. absence of donor risk,~        3. low risk of transmissible infectious diseases,~        4. low risk of acute GvHD (Graft vs. Host Disease)~      The three main causes of death after umbilical cord blood transplantation for these kind of~     disorders are graft failure, infection and disease relapse.~      In this study we are trying to address these three problems:~      To help improve engraftment we will add the drug Fludarabine to Cytoxan and total body~     irradiation. Fludarabine is a very strong medicine. We will try to decrease infections and~     reduce leukemia relapse by using fludarabine instead of antithymocyte globulin (ATG).~   "
177052|NCT01247675|"~     This study investigates the safety, tolerability, pharmacokinetic profile (PK), and~     pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared~     to one dose-level of an approved daily human growth hormone product over a period of 4 weeks~     (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone~     Deficiency.~   "
177053|NCT01247662|"~     Autism spectrum disorder (ASD) is a pervasive neurodevelopmental disorder with prominent~     reciprocal social and communication impairment and restricted repetitive behavior or~     interest. ASD is a highly heritable disease with tremendous impact on individuals, families,~     and society. In addition to the interview instruments, self-administered rating scales are~     commonly used in screening, assessment of symptoms' change, and evaluation of intervention~     effects. The Social Responsiveness Scale, the Childhood Asperger's Syndrome Test, and the~     Autism Spectrum Quotient are internationally widely used rating scales measuring autistic~     traits in both clinical and community samples in western counties. Establishment of~     internationally-recognized reliable and valid instruments is not only useful for clinical~     screening, but also helpful in future functional outcomes, neurocognitive, genetic and brain~     imaging studies.~   "
177054|NCT01247649|"~     The present study is aimed to evaluate the feasibility of a new noninvasive method to measure~     continuous glucose values using electromagnetic radiation.~   "
177055|NCT01247636|"~     The purpose of this randomized controlled trial is to evaluate the effectiveness of an~     exercised-based programme developed for older people admitted at a geriatric outpatient~     clinic and to see if a home-exercise program enhances the effect. The outcomes considered is~     health-related quality of life, balance-self confidence, balance and mobility.~   "
177056|NCT01247623|"~     Primary objective: Determination of safety and tolerability of GV1001 administration combined~     with Temozolomide (based on blood samples and adverse events).~      Feasibility of combining active immunisation with Temozolomide treatment. Determination of~     immunological response after administration of GV1001 and Temozolomide as measured by~     presence of DTH skin test reaction and specific T-cell responses.~      Secondary: Evaluation of objective tumour response~      The trial is an exploratory study which main objective is to estimate safety and feasibility~     of combining active immunisation with chemotherapy. However, the trial may also indicate the~     efficacy of the combination.~   "
177057|NCT01247610|"~     Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%),~     early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high~     heritability. Due to its lifelong impairments up to adulthood, adult ADHD has drawn much more~     attention in Western studies in the past decade; however, there has been no such study in~     Asian countries. The ultimate goals of this longitudinal follow-up study are to investigate~     the outcomes of a cohort of children with attention-deficit/hyperactivity (ADHD) and their~     healthy controls at young adulthood as the primary aim; and to test whether structural and~     functional brain connectivity can be endophenotypes of ADHD, to localize the brain area that~     are corresponding to methylphenidate treatment effects, and to identify the genetic variants~     corresponding to the persistence of ADHD, treatment effect of methylphenidate, neurocognitive~     dysfunction, and structural and functional dysconnectivity in the brain as the secondary~     aims. With the accomplishment of these goals, this study will provide the first-hand data on~     adult ADHD in non-western countries, and will be one of few world-class studies on the topics~     of neurocognitive and imaging genomics on adult ADHD.~   "
177131|NCT01246648|"~     The etiopathogenesis of periodontal disease results from complex interaction between~     infectious agents, mainly including bacteria, and host cellular and humoral immune responses.~     However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain~     all biological and clinical features of the destructive periodontal disease. The main~     hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by~     altering epithelial gingival cell biology and consequently may promote the initiation and~     progression of periodontitis.~   "
177058|NCT01247597|"~     Background:~      - Pleuropulmonary blastoma (PPB) is a rare fast-growing lung tumor that is associated with~     other, rare tumor types. Most cases of PPB appear in children younger than 6 years of age.~     Recently, it has been shown that this condition can be inherited (e.g., mutation of the~     DICER1 gene). Researchers are studying both clinical and genetic aspects of this newly~     described condition. They are interested in collecting further medical history and genetic~     information on individuals and close relatives of individuals who have PPB or other rare~     associated tumors.~      Objectives:~      - To study individuals with a personal or a family history of pleuropulmonary blastoma (PPB)~     or other rare tumors that can be associated with PPB (e.g., cystic nephroma, nasal~     chondromesenchymal hamartoma, ovarian Sertoli-Leydig cell tumors, ocular medulloepithelioma).~      Eligibility:~        -  Individuals who have been diagnosed with PPB and/or PPB-related tumors.~        -  Close blood relatives (e.g., parents, siblings, grandparents) of individuals who have~          been diagnosed with PPB and/or PPB-related tumors.~      Design:~        -  Interested participants can enroll or inquire about this study by calling~          1-800-518-8474.~        -  Participants will be asked to complete family history and medical history~          questionnaires. They will complete the questionnaire if they are at least 18 years of~          age, or another person will complete the questionnaire if the key family member is too~          young to do so on his or her own.~        -  Participants will be asked to sign a medical record release form to allow researchers to~          examine detailed medical history information.~        -  Participants may be asked to have a physical examination and imaging studies, provide~          blood and saliva samples, or provide tumor tissue from prior biopsies or cancer~          surgeries.~        -  Annually, participants will update the family history and individual information~          questionnaires to document important changes in medical history, and will also update~          the medical record release form. Participants may be asked to provide additional cheek~          lining cells and/or blood samples, as well as tumor tissue from any new or planned~          biopsies or tumor surgeries.~        -  Treatment will not be provided as part of this protocol.~   "
177059|NCT01247584|"~     RATIONALE: Studying bone marrow samples from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in samples from young patients with acute~     myeloid leukemia.~   "
177060|NCT01247571|"~     This phase II trial studies how well pazopanib hydrochloride works in treating patients with~     uterine cancer that has come back or has not responded to treatment. Pazopanib hydrochloride~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Pazopanib hydrochloride may also stop the growth of uterine cancer by blocking blood flow to~     the tumor.~   "
177061|NCT01247558|"~     This study will be an observational cohort study utilizing administrative claims data with~     100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria~     and 400 propensity score matched patients meeting the same criteria to serve as a control~     cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore~     Integrated Research Database for claims submitted during the time period of 01/01/2002~     through 06/30/2007.~   "
177062|NCT01247545|"~     Coronary heart disease (CHD) is the leading cause of death in the UK, accounting for 124,000~     deaths (2006) and costing the UK economy over £7.9 billion a year. Patients with severe CHD~     are usually treated by coronary artery bypass graft (CABG) surgery, the risks of which are~     increasing due to older and sicker patients being operated on. New treatment strategies are~     therefore required to improve health outcomes in these high-risk patients undergoing CABG~     with or without valve (CABG±valve) surgery.~      The hypothesis tested in this research proposal is that remote ischaemic preconditioning~     (RIC), a virtually cost-free, non-pharmacological and simple non-invasive strategy for~     reducing the damage to the heart muscle at the time of surgery, improves health outcomes in~     high-risk patients undergoing CABG±valve surgery.~      In this research project, 1610 high-risk patients undergoing CABG±valve surgery will be~     recruited via 28 UK hospitals performing heart surgery. Patients will be randomly allocated~     to receive either RIC or control. For RIC, a blood pressure cuff will be placed on the upper~     arm to temporarily deprive it of oxygen and nutrients, an intervention which has been shown~     in the investigators pilot studies to reduce damage to the heart muscle by up to 40% during~     CABG±valve surgery. The investigators will determine whether RIC can improve health outcomes~     in terms of better patient survival, less heart attacks and strokes, shorter hospital stay;~     less damage to the heart, kidney and brain during surgery; better heart function post-surgery~     and less chance of developing heart failure; better exercise tolerance and quality of life.~   "
177063|NCT01247532|"~     The purposes of the proposed study are (1) to collect data on the feasibility of offering~     Mindfulness-Based Stress Reduction (MBSR) as an intervention to reduce fatigue and~     psychological distress in cancer patients who are not in active treatment for their cancer~     and (2) to estimate effect sizes of the intervention for fatigue, depression, anxiety, and~     sleep disturbance. The investigators also will obtain preliminary effect sizes of the degree~     to which the intervention increases mindfulness, and the investigators will evaluate dosage~     effects. Findings will suggest whether a future randomized controlled trial with~     cancer-related fatigue (CRF) as the primary outcome is feasible and warranted.~      Participants will be randomly assigned to either the MBSR intervention arm or to a wait-list~     control arm. The MBSR intervention will consist of a weekly 2-hour class to be held for seven~     consecutive weeks in the Indiana University Simon Cancer Center Pavilion; the class on week~     six will be extended to a 3-hour retreat. Participants will be invited to engage in daily~     home practice of meditation and other mindfulness exercises. All participants will complete a~     series of self-report questionnaires prior to the start of the classes, immediately following~     the end of classes, and 1 month after the class ends. Those in the intervention arm will~     begin the MBSR class the week after enrollment; the control group will be offered the same~     7-week program after 1-month post-intervention follow-up assessments are~     completed—approximately 13 weeks after enrollment.~      Primary Aim 1: Obtain preliminary RCT effect sizes for changes in fatigue of an MBSR~     treatment group compared to a wait-list control group.~      Hypothesis 1: Immediately post-intervention (T2), improvements in fatigue compared to~     pre-intervention (T1) will be greater in the treatment group than the control group.~      Hypothesis 2: At 1 month post intervention (T3), improvements in fatigue compared to~     pre-intervention (T1) will be greater in the treatment group than improvements in the control~     group.~   "
177064|NCT01247519|"~     The investigators will perform and evaluate a post-hospitalization telecare system for~     compensating the discontinuity from the hospitalist care system.~   "
177065|NCT01247506|"~     The purpose of this study is to identify different genetic features in hepatocellular~     carcinoma. It will assist in predicting individual risks of disease progression and would~     help to clarify pathophysiological mechanisms of HCC.~   "
177066|NCT01247493|"~     A phase II clinical trial evaluating the efficacy and tolerability of induction and~     consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin~     (modified-FLAI) in the elderly patients with acute myeloid leukemia.~   "
177079|NCT01247324|"~     This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy~     and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with~     relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab~     600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the~     first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks,~     with placebo injections matching interferon beta-1a SC three times per week; or interferon~     beta-1a 44 mcg SC injections three times per week (with placebo infusions matching~     ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96~     weeks. Participants who complete the 96-week double-blind treatment will have an option to~     enter a single-group, active-treatment, open-label extension period, providing they fulfill~     the eligibility criteria.~   "
177067|NCT01247480|"~     Major Aims of study:~        1. To create a gene expression-based prognostic device that complements or exceeds the~          prognostic utility of conventional biomarkers of breast cancer outcome.~        2. To identify one or more clinical subgroups of patients for which the prognostic device~          outperforms, or substantially adds to, the prognostic performance of conventional~          markers that currently determine therapeutic strategies.~      Sub-Aims of study:~        1. Assess the prognostic value of the multiple gene expression signatures, alone and in~          combination, using a large cohort of breast cancer patients for which pathology,~          treatment and outcome is available. A training and testing design is proposed.~        2. Evaluate the utility of a prognostic device that measures gene expression levels from~          formalin-fixed paraffin-embedded specimens (FFPEs) of primary resected tumors. The~          investigators will utilize the Affymetrix Quantigene 2.0 Assay and/or the Illumina~          BeadXpress VeraCode DASL Gene Expression Assay (FDA-approved IVDMIA.)~        3. For specific clinical subgroups of patients/tumors, the investigators will~          mathematically identify additive or synergistic prognostic relationships between genes~          and gene signatures that, in combination, will yield maximal risk prediction (distant~          metastases-free survival) for patients.~        4. Compare the prognostic utility of the investigators device to that of the conventional~          prognostic variables that are currently used to determine therapeutic strategy.~        5. Incorporate the prognostic signatures into a practical prognosis algorithm that seeks to~          include conventional measures of outcome such as tumor size, histologic grade, nodal~          status, patient age, or Nottingham index, etc.~      The investigators hypothesize that adequate quality and quantity of tumor RNA may be~     extracted from archival paraffin-embedded tumor specimens for gene expression profiling, and~     that archival tumor-derived genomic signatures may be used as prognosticators or predictors~     in breast cancer.~   "
177068|NCT01247467|"~     A number of prognostic and/or predictive genomic signatures for breast cancer have been~     developed by Genome Institute of Singapore (GIS). In the past 1 year, GIS has developed~     protocols and methods to conduct expression assays from formalin-fixed, paraffin-embedded~     (FFPE) tumor specimens. A study on 800 tumor samples is planned to analyze these gene~     signatures and compare them with conventional clinical prognosticators and predictors. As the~     investigators plan to use archival tumor samples that dates back to the 1990s, the aim of~     this pilot study is to first analyze 10 anonymized samples to determine the feasibility of~     running these assays on old archival blocks. The information generated will help us determine~     whether very old samples (diagnosed before 2000) may be selected for the actual study.~   "
177069|NCT01247454|"~     There will be no significant decrease in the use of low dose acetylsalicylic acid (ASA)~     therapy for primary prevention across the three intervention arms from baseline to completion~     of the project.~      There will be no significant differences in the percentage of patients with diabetes mellitus~     greater than 44 years of age on low dose ASA therapy for primary prevention across the three~     arms of the study using repeated measures from baseline to completion of the project.~   "
177070|NCT01247441|"~     The Breast Cancer Registry aims to collect clinical data of all breast cancer patients~     diagnosed and/or treated in the National University Hospital, with the goal of understanding~     risk factors, presenting symptoms, diagnosis, treatment, and outcome data of breast cancer in~     Singapore. This information will contribute to improving management of breast cancer~     patients.~   "
177071|NCT01247428|"~     The DESSOLVE I clinical trial is to assess the safety and performance of the~     sirolimus-eluting MiStent SES.~   "
177072|NCT01247415|"~     During the 2009-2010 immunization campaign against pandemic H1N1, some people reported having~     allergic-like reactions (anaphylaxis(a shock-like reaction), hives, swelling, etc.). A~     vaccine allergy may be more or less severe or intense. Patients may have skin reactions (rash~     with or without itching), respiratory problems (cough, spasm of the airways), angioedema~     (swelling) of various body parts (face, eyelids, throat etc.) and circulatory problems (low~     blood pressure or shock). Anaphylaxis is a severe allergic reaction that can sometimes be~     fatal. Other people vaccinated against pandemic H1N1 had an oculo-respiratory syndrome.~     Oculo-respiratory syndrome (ORS) is also a reaction to the influenza vaccine, which includes~     symptoms such as bilateral conjunctivitis (red eyes) with swelling of the face or respiratory~     symptoms (chest tightness, coughing, a sensation of throat closure, difficulty swallowing,~     hoarseness, wheezing or difficulty breathing). The investigators know that ORS is not a true~     allergic reaction. Because many signs and symptoms of ORS are similar to those observed~     during an allergic reaction, it is often difficult to distinguish ORS from an allergic~     reaction.~      This study will compare three groups of patients: those who had allergic-like reactions,~     those who had ORS and vaccinated individuals who had no such adverse events. Pregnant women~     cannot participate in this study. The study has three goals. First, the investigators want to~     determine, among those who had allergic-like reactions after influenza vaccination, what~     proportion (percentage) of these people are actually allergic to the vaccine or its~     components. Second, among those who are not allergic to the vaccine, which other processes~     may have caused these symptoms. Finally, the investigators will try to identify whether there~     are features that distinguish patients who have a true allergic reaction from those affected~     by ORS, and those that had no adverse events.~   "
177073|NCT01247402|"~     Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial,~     in which consecutive patients candidates for percutaneous intervention of angioplasty to~     treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will~     be assigned to one of two study arms:~        1. Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA)~        2. Control Arm: standard percutaneous transluminal angioplasty (sPTA).~      Purpose:~      To evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous~     transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents~     compared to standard percutaneous transluminal angioplasty (sPTA).~   "
177074|NCT01247389|"~     Incisional hernia (IH) is a common complication of midline laparotomy. Despite the hope that~     laparoscopic colon resection would result in fewer incisional hernias, prospective studies~     demonstrate a similar incidence to open surgery. Observational studies suggest that the rate~     of incisional hernia after laparoscopic colon resection may be reduced with the use of a~     transverse compared to a midline extraction incision. However, no randomized trails are~     available, and a midline extraction incision for hemicolectomy remains the standard current~     approach. The investigators hypothesize that the use of a lower abdominal transverse muscle~     splitting incision for specimen extraction in laparoscopic colon surgery will result in fewer~     incisional hernias compared to a midline periumbilical extraction incision.~   "
177075|NCT01247376|"~     Abstract~      Background:~      Local external cooling of the postoperative field is a treatment paradigm aiming for enhanced~     recovery after joint surgery. It is supposed to reduce pain and improve mobilization,~     enabling same day surgery.~      Hypothesis:~      Systematic postoperative cooling and compression after knee arthroscopy will reduce pain and~     also be reflected by changes in local levels of metabolic and inflammatory variables in the~     synovial membrane.~      Study design:~      Prospective randomised study; Level of evidence 1.~      Methods:~      Forty-four otherwise healthy patients were included in the study and randomised to systematic~     cooling and compression or NO cooling and compression after knee arthroscopy. Microdialysis~     of the synovial membrane was performed postoperatively with measurements of PGE2, glucose,~     lactate, glycerol, glutamate and blood flow (ethanol exchange ratio). Local temperature was~     monitored as well as postoperative pain (VAS and NRS).~      Results:~      The application of a cooling and compression device after knee arthroscopy resulted in~     significantly lower temperature in the operated knee (skin, joint capsule and~     intraarticularly).~      The cooling and compression diminished energy requirements in synovial tissue and a 3~     temperature sensitive influence on inflammation (PGE2) were shown. No effect on postoperative~     pain was detected.~      Conclusion:~      Local cryotherapy and compression after knee arthroscopy significantly lowered local knee~     temperature postoperatively. A correlation with synovial PGE 2 and temperature was shown.~      Since PGE2 is a pain and inflammatory marker this implicates a positive anti-inflammatory~     effect induced by postoperative local cooling and compression. Hypothermia is proposed to~     have a protective effect in ischemic tissue. This is probably due to a decreased metabolic~     rate and therefore decreased energy requirements as shown by stable levels of lactate despite~     lower blood flow indicated by increasing ethanol ratio.~   "
177084|NCT01247259|"~     Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic~     rhinitis. It is often suggested that polysensitized patients might not benefit from specific~     immunotherapy as much as monosensitized patients, although further research on this subject~     is needed. This study compared the efficacy of SLIT with standardized house dust mite extract~     in mono- and polysensitized allergic rhinitis patients.~      Patients who were sensitized to house dust mites and treated with SLIT for house dust mites~     for at least 1 year between November 2007 and March 2010 were included. The mono-allergen~     sensitized group (Mgr) was defined as the patients who were sensitized to Dermatophagoides~     pteronyssinus (Dp) or D. farinae (Df; n = 70). The poly-allergen sensitized group (Pgr) was~     defined as the patients who were simultaneously sensitized to house dust mites and other~     allergens (n = 64). A standardized extract of house dust mites was used for immunotherapy.~     Anti-allergic medication and the total nasal symptom score (TNSS), including rhinorrhea,~     sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after SLIT.~      This study enrolled 134 patients. The TNSS improved significantly after SLIT in both groups,~     while the change in the TNSS did not differ significantly between the groups. The~     anti-allergic medication scores also decreased significantly in both groups, but there was no~     significant difference between the groups.~      In polysensitized allergic rhinitis patients, SLIT for Dp/Df gave comparable improvements in~     both nasal symptoms and rescue medication scores to those in monosensitized patients,~     regardless of other positive allergens. SLIT for Dp/Df might be considered in polysensitized~     allergic rhinitis patients.~   "
177085|NCT01247246|"~     This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially~     stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in~     subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral~     cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of~     approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and~     Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately~     12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.~   "
177086|NCT01247233|"~     The standard treatment for localized breast cancer is based on conservative surgery (when~     possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended~     total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to~     the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the~     difficulty for many patients to reach RT centers to receive standard whole breast irradiation~     (WBI) after conservative surgery. APBI offers decreased overall treatment time and several~     theoretical advantages over WBI, including a decrease in dose delivered to uninvolved~     portions of the breast and adjacent organs. If equivalence between the two treatments can be~     shown, then APBI will be considered as a historic evolution in breast cancer management.~      In this phase III trial, designed in postmenopausal women > 50 years of age, the objective is~     to compare the effectiveness and safety of APBI compared with whole breast irradiation. This~     study is also designed to ensure high quality criteria for surgery, pathology and RT~     techniques in the 3 arms and will allow to provide data on economics and costs.~   "
177087|NCT01247220|"~     Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab~     (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated~     with improved vision results. There is a subgroup of patients with peripheral nonperfusion on~     ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment.~      In this trial the investigators compare the gold standard of monthly ranibizumab injections~     with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography. Each~     group will have monthly injections for the first six months, then as needed by either visual~     acuity decrease or increased retinal thickness for the subsequent six months.~      The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence~     tomography, and number of ranibizumab injections~   "
177088|NCT01247207|"~     Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is~     caused by a mutation in the gene for dystrophin, a protein that is important for maintaining~     normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads~     to weakness and loss of walking ability during childhood and teenage years. A specific type~     of mutation, called a nonsense (premature stop codon) mutation, is the cause of DBMD in~     approximately 10-15% of boys with the disease. Ataluren is an orally delivered,~     investigational drug that has the potential to overcome the effects of the nonsense mutation.~     This study is an open-label trial for patients with nonsense mutation dystrophinopathy who~     received ataluren in a prior PTC-sponsored study at a US clinical trial site. This trial will~     be conducted at sites in the US and will evaluate the long-term safety of ataluren, as~     determined by adverse events and laboratory abnormalities.~   "
177089|NCT01247194|"~     The purpose of the study is to assess the safety, tolerability, antiviral effects, and~     pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.~   "
177090|NCT01247181|"~     The investigators hypothesize that sending weekly motivational text messages to people~     infected with HIV will encourage them to take their medication, compared to usual care.~   "
177091|NCT01247168|"~     This study is being conducted to test study drug AZD2461 to see how it may work to treat~     solid tumors. The main purpose of this study is to determine the safety and tolerability of~     AZD2461. This is the first time the drug has been given to humans and is classed as a first~     time in man study. Its main purpose is to establish a safe dosage of the drug and provide~     additional information on any potential side effects this drug may cause. The study will also~     assess the blood levels and action of AZD2461 in the body over a period of time and will~     indicate whether the drug has a therapeutic effect on solid tumors.~   "
177092|NCT01247155|"~     The purpose of this randomized trial was to examine the value of the review on the first~     postoperative day after uneventful phacoemulsification cataract surgery.~   "
177093|NCT01247142|"~     The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive~     pulmonary aspergillosis in exhaled breath condensate.~   "
177094|NCT01247129|"~     The purpose of this study is to determine whether delaying the superficial inferior~     epigastric artery (SIEA) flap results in widening of diameter and enhancing of blood flow of~     its donor artery.~   "
177097|NCT01247090|"~     The death rate of patients with endstage renal disease (ESRD) on dialysis each year is 20%,~     with diseases related to the heart and blood vessels causing about half. About 60% of~     patients on hemodialysis have high blood pressure, which is poorly controlled in most. Normal~     blood pressure in these patients greatly improves the chance of living. Increased fluid in~     the body and bloodstream is a major cause of hypertension in patients with ESRD. Fluid~     removal during hemodialysis is often limited by symptoms of low blood pressure during the~     procedure. Therefore the increase in fluid and related high blood pressure is ongoing for~     many of these patients. Arginine vasopressin (AVP) is a hormone naturally produced by the~     body which has little effect on blood pressure in healthy people, but acts as a powerful~     vasoconstrictor (narrows the blood vessels) when blood pressure is threatened. Recent studies~     have shown when there is too little AVP, patients are more likely to have low blood pressure~     during dialysis that limits fluid removal, an effect that can be reversed by giving these~     patients low doses of AVP. This phase II trial will find out which of two doses of AVP (.15~     or .30 mU kg-1 min-1), in combination with standard therapy, works best to change~     interdialytic 44-hour ambulatory systolic blood pressure after 2 weeks. Patients who enroll~     in this study will be divided into three groups. One group will be given a 0.15 mU kg-1 min-1~     dose of AVP at each dialysis session over a 2-week period; the second group will be given AVP~     0.3 mU kg-1 min-1 at the same interval; and a third group will be given normal saline~     (placebo) at the same interval. All patients will be closely monitored for side-effects.~   "
177098|NCT01247077|"~     Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from~     weight loss, increased heart rate and stress intolerance. Some patients have difficulties in~     regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin,~     suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory~     antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in~     western Europe. This compound has important function in thyroid hormone metabolism and on the~     immune system. It is not known whether addition of selenium affects the well being of~     patients with Graves´thyrotoxicosis. The subject of this study is to investigate this~   "
177099|NCT01247064|"~     The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS)~     improves respiratory distress in children 2-23 months presenting to the emergency department~     (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with~     a trial of nebulized albuterol.~   "
177100|NCT01247051|"~     The study is a single-center, randomized, un-blinded treatment study in which patients (>78~     years) with the use off a heart-lung machine were provided into two study arms.~      Patient wit precoating have a filling of the machine with their own blood. In the~     comparator arm, a standard priming is used.~   "
177101|NCT01247038|"~     The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal~     articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal~     articulation using the same cup in regards to the composite clinical success (CCS) rate at 2~     years postoperatively (delta = 10% minimum clinically significant difference in rates).~   "
177102|NCT01247025|"~     The primary research question in this study will ask, among those receiving outpatient mental~     health services (MHS) at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans~     Affairs Medical Center (VAMC), how many suffer from Prolonged Grief Disorder (PGD)? Here, it~     is hypothesized that PGD will occur within the sample. A secondary aim of this study will be~     to investigate how often PGD co-occurs with posttraumatic stress disorder (PTSD) and/or~     depression. Also, while PGD has been shown to have an effect on self-directed violence (SDV)~     among civilians (Prigerson, Bridge et al., 1999), no studies yet have examined the~     relationship between PGD and SDV among Veterans. Therefore, it also is hypothesized that as~     PGD severity increases among the Veteran sample, risk for SDV will increase as well.~     Additional research aims also will be addressed in this study. For one, it will be assessed~     which grief symptoms are most often reported among the Veteran sample. Also, no study has yet~     to examine if there are neuropsychological differences between PGD and PTSD. Therefore,~     another research question here is whether PGD indeed is neuropsychologically different from~     PTSD. Here, the exploratory hypothesis is that PGD sufferers will respond to a measure of~     multiple components of cognition (e.g., planning, sequencing, concentration, multitasking,~     and memory efficiency) in a manner that is significantly different from PTSD sufferers.~   "
177103|NCT01247012|"~     Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver~     disease (PNALD). The purpose of this study is to determine the effect of treatment with a~     smaller amount lipid minimization) of our standard soybean oil based intravenous lipid~     emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with~     severe cholestasis.~   "
177104|NCT01246999|"~     A total of 88 children between 2 and 9 years of age will be randomized to receive a two dose~     schedule of either licensed live attenuated trivalent seasonal influenza vaccine (LAIV) or~     licensed inactivated seasonal influenza vaccine (TIV)or TIV followed by LAIV or LAIV followed~     by TIV separated by 28 days. Children with a laboratory documented history of prior H1N1~     infection will be excluded.~   "
177105|NCT01246986|"~     The purpose of this study is to estimate the median time to progression in participants with~     hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination~     with sorafenib or ramucirumab.~   "
177106|NCT01246973|"~     The purpose of the study is to determine whether curcumin, an ingredient of some foods, can~     prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy.~     Dermatitis is a common side effect of radiation treatment, but few effective treatments have~     been developed for it. Curcumin is a natural compound found in both turmeric and curry~     powder. It has been used for centuries as a spice (curry), a food coloring and as a food~     preservative. Curcumin is non-toxic and has been found to enhance the functions of normal~     tissues..~   "
177107|NCT01246960|"~     The purpose of this study is to determine whether ramucirumab when used in conjunction with~     chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal~     cancer.~   "
177132|NCT01246635|"~     The purpose of this clinical study is to demonstrate the effectiveness and safety of the~     Trufit CB (Cartilage Bone) implant for the treatment of single, isolated cartilage defects of~     the knee compared to Microfracture.~   "
177108|NCT01246947|"~     The mitral valve is the inflow valve into the main pumping chamber of the heart. It can~     become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When~     patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either~     fix or replace the valve. Many patients with mitral valve disease also develop a leaky~     tricuspid valve - the tricuspid valve is the inflow valve to the right side of the heart (the~     right heart pumps blood across the lungs). The amount of leakiness of the tricuspid valve is~     determined by an ultrasound test, and the amount of leakiness is graded as: none, mild,~     moderate, or severe. When a heart surgeon operates on a patient with a diseased mitral valve,~     he or she will fix the tricuspid valve if the tricuspid leakage is severe. This involves~     sewing a cloth-covered ring around the valve and narrowing it. If the tricuspid valve leakage~     is only mild (or absent), the surgeon will leave the tricuspid valve alone at the time of~     mitral valve surgery. If the tricuspid valve has moderate leakage surgeons are uncertain~     about what to do. In a recent review of thousands of patients across the nation having mitral~     valve surgery with moderately leaky tricuspid valves, 35 % of patients had tricuspid valve~     repair. Since the investigators don't know what the best approach is: to leave the moderately~     leaky tricuspid valve alone or to fix it with a cloth-covered ring, the investigators propose~     a study to determine which approach is best. Patients having mitral valve surgery with a~     moderately leaky tricuspid valve will be randomized to either 1. have a tricuspid valve~     repair or 2. to not have a tricuspid valve repair. The investigators will carefully follow~     these patients for two years and see if heart function is better among those who got their~     valve fixed.~   "
177109|NCT01246934|"~     In this study the investigators are presenting the advantages as well as the disadvantages of~     ACUTE SHORTENING AND RELENGTHENINIG VS SEGMENT TRANSPORT methods.~   "
177110|NCT01246921|"~     Rationale: Vitiligo vulgaris is a common acquired pigment disorder, which is characterised by~     the development of depigmented macules. It develops probably due to immunedestruction of~     melanocytes. Most effective therapies are immunsuppresive:~        1. local immunesuppressives like corticosteroids and calcineurin inhibitors~        2. phototherapy like PUVA and NB-UVB phototherapy. NB-UVB is the first choice A synergistic~          effect of UVA and topical corticosteroids (fluticasone proprionate 0.05% cream) has been~          described by Westerhof et al. in 1999. To our knowledge to date there are no~          publications comparing NB-UVB combined with a topical corticosteroid and NB-UVB alone.~      Objective: The objective of this study is to evaluate the clinical effects (onset and degree~     of repigmentation) of fluticasone proprionate 0.05% cream (thrice weekly) on NB-UVB~     phototherapy twice weekly for a period of 12 months.~      Study design: Prospective single blinded randomised controlled study. Study population:~     Consecutive patients ≥ 18 years, diagnosed with active vitiligo vulgaris who will receive~     NB-UVB phototherapeutic treatment at the Netherlands Institute for Pigment Disorders at the~     Academic Medical Centre (AMC), University of Amsterdam.~      Methods: The patient will be randomised for either NB-UVB phototherapy and fluticasone~     proprionate 0.05% cream or NB-UVB phototherapy alone for 12 consecutive months.~      Main study parameters/endpoints: The onset and degree of repigmentation is assessed by~     digital image analysis of a target lesion and blinded global physician assessment.~     Furthermore, the patients and doctors satisfaction will be assessed and changes of~     immunohistochemical parameters will be analysed in skin biopsies.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Subjects participating in the study will be asked to visit the institute 4~     times. The time investment will be 20 minutes per visit. Additionally, patients will be asked~     for consent to take punch biopsies (3 mm) at the beginning and at the end of the treatment~     period. Hence, skin biopsies are not compulsory for participation in this study. Patients may~     chose to participate in the clinical non invasive part of the study. Known side effects of~     the NB-UVB phototherapy are redness, pruritus, xerosis cutis, burning sensation and~     conjunctivitis. These side-effects however, are largely dose-dependent and avoidable.~     Corticosteroid associated systemic side-effects (suppression of the adrenocortex) will be~     minimized by treating only a limited body surface [a maximum of 30% body surface] and by~     using an intermittent application scheme of three days a week in the long term treatment. The~     regions which are known to have a higher absorption are excluded (periorbital, axillary,~     inguinal and genital area). Both topical corticosteroids and NB-UVB are part of the Dutch and~     British guidelines for the treatment of vitiligo. There is no presumptive evidence or~     indication that the combination of these therapies may result in a higher risk of side~     effects.~      All together the burden due to the study is low and the risk for systemic or local side~     effects is low.~   "
177111|NCT01246908|"~     The purpose of this study is to determine if CX157 is effective and safe in patients with~     treatment of treatment resistant depression over six weeks of treatment.~   "
177112|NCT01246895|"~     This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured~     lesion (investigational) and microfracture alone (control) for up to 5 years from treatment~     in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post~     approval study for these Protocols, in support of a commercial application. The lesions~     treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage,~     grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral~     condyles of the knee, and were classified as either acute or chronic.~   "
177113|NCT01246882|"~     The purpose of this study is to determine the effects of daily feedback about physical~     activity (number of bouts of walking, duration of bouts, total walking distance, average and~     fastest walking speed) and walking average speed compared to feedback about walking speed~     only on walking-related outcomes during inpatient rehabilitation for stroke. For the first~     time, daily walking and other exercise will be monitored by bilateral triaxial accelerometers~     on the ankles. Activity-recognition algorithms will analyze the inpatient sensor data and~     return a summary to the participants at each site.~   "
177114|NCT01246869|"~     Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole)~     in patients with (1) newly diagnosed primary malignant brain tumors (WHO [World Health~     Organization] Grade III or IV glial-based tumors) who have not had a complete surgical~     resection and by contrast MRI (Magnetic resonance imaging) have residual tumor > 1.0 cm in~     diameter and will be receiving radiotherapy or (2) newly diagnosed brain metastasis (> 1.0 cm~     in diameter who will be receiving radiotherapy. The ability to accurately assess tumor~     hypoxia and accurately determine the amount/degree of tumor hypoxia could potentially change~     patient management once validated as tumor hypoxia is known to be associated with a poor~     prognosis [Eyler 2008].~   "
177115|NCT01246856|"~     Many patients with breastcancer in the past, were treated with TAC. These last years, there~     is more and more focus on the effects of chemotherapy, particularly in children treated with~     this. One of these effects is damage to the heart muscle, which ultimately might affect the~     pump-function of the heart . In adults, the effect of treatment with TAC on the heart, has~     not been previously investigated. The possibility exists that the adverse reactions in~     children are found in adults also could occur. Therefore we have initiated this trial.~   "
177116|NCT01246843|"~     Patients with advanced kidney cancer or GIST (Gastro Intestinal Stromal Tumor: this is a~     tumor of the intestines) may be eligible for treatment with one of the following drugs:~     sunitinib (Sutent ®) or sorafenib (Nexavar ®). These drugs inhibit blood vessel formation in~     cancer cells. These cancer cells are hampered in their growth. To enlarge the investigators~     knowledge on the effects and side effects of these two medicines, in the University Medical~     Center St. Radboud lot of research is done. This study is a part of that.~      Patients receiving sunitinib or sorafenib tell sometimes that they feel that they are less~     able to concentrate, that their memory is not working properly or that they are less able to~     imagine a solution to a complex problem . Perhaps you recognize these symptoms as well. In~     how many of the patients this occurs, how severe the symptoms are and how it is caused, is~     still unknown.~      The goal of this research is to examine how memory, concentration and knowledge processing~     works in patients using sorafenib or sunitinib. With the research the investigators hope to~     get answers to the following questions:~        1. How common are problems with memory, concentration and processing of knowledge in~          patients receiving the drug sunitinib or sorafenib?~        2. What are the problems of memory, concentration and processing of knowledge in the use of~          sunitinib or sorafenib?~        3. What could be the cause of the problems that patients experience from memory,~          concentration and processing of knowledge in the use of sunitinib or sorafenib?~        4. Is there a link between problems with memory, concentration and processing of knowledge~          and also experiences of fatigue or mood of a patient?~   "
177133|NCT01246622|"~     This phase I trial is studying the side effects and best dose of lenalidomide when given~     together with cytarabine in treating patients with relapsed or refractory acute myeloid~     leukemia (AML). Biological therapies, such as lenalidomide, may stimulate the immune system~     in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving lenalidomide together with cytarabine may~     kill more cancer cells~   "
177117|NCT01246830|"~     Research questions:~        1. Will the panoramic images derived from cone beam CT data give better diagnostic ability~          than conventional panoramic radiographs?~        2. Will 3D cephalometric analysis offer the orthodontists and surgeons better information~          for treatment planning?~        3. Will the 3D cephalometric analysis give more accurate treatment plan and better~          treatment outcome?~      General hypothesis and special aims~      Overall aims:~        -  To compare 2D versus 3D cephalometric analysis: treatment planning and therapeutic~          outcome.~        -  To determine the accuracy and diagnostic ability and usability of the 3D cephalometric~          analysis.~        -  To evaluate the diagnostic ability and usability of the panoramic image derived from~          cone beam CT data as compared to 2D panoramic images.~        -  To evaluate the value of the cone beam CT data in cephalometric analysing process for~          orthodontic and maxillofacial surgery treatment.~      Hypotheses:~        1. The availability of the 3D cephalometric analysis influences the orthodontic and~          maxillofacial treatment plan and decision, and might change the treatment outcome.~        2. Panoramic images derived from cone beam CT data may provide equal information for~          diagnosis as conventional panoramic images.~        3. Cone beam CT will be able to replace classic orthodontic imaging being more time and~          dose efficient and having a beneficial effect on treatment outcome.~   "
177118|NCT01246817|"~     This study uses one trialdrug: Temsirolimus (sometimes called Torisel ® ). Temsirolimus is an~     mTOR inhibitor. It is an agent that is specifically aimed at disrupting cell division (needed~     for cancer cell growth). Temsirolimus has been shown to inhibit the growth of cancer cells.~     For patients with metastatic kidney cancer Temsirolimus is now a registered , conventional~     therapy. It has been recorded for patients as they get renal cell cancer metastases and which~     looks as if the tumor is aggressive.~      This is a phase II trial. This means that the investigators look at how effectively~     temsirolimus is, after treatment with other drugs against kidney cancer. Effective means that~     the investigators see how well the treatment is, the investigators look at how long the~     disease is not growing and if it does, that is smaller. The possible side effects will be~     carefully watched.~   "
177119|NCT01246804|"~     The objective of this study is to evaluate the effect of ginkgo biloba (steady state) on the~     pharmacokinetics of a single dose of the UGT-substrate raltegravir. Furthermore the safety~     profile of the combination is studied.~   "
177120|NCT01246791|"~     The purpose of this study is to assess the pharmacokinetic profiles of norethisterone and~     ethinyl estradiol after single oral administration of NPC-01 in healthy female volunteers.~      Pharmacokinetics of norethisterone and ethinyl estradiol will be evaluated on the basis of~     AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.~   "
177121|NCT01246778|"~     Rationale:~      Recently, sunitinib (a tyrosine kinase inhibitor that is used for treatment of metastatic~     renal carcinoma and gastrointestinal stroma tumors) has been associated with development of~     heart failure, possibly by off-target inhibition of AMP-protein kinase. The investigators~     hypothesize that sunitinib reduces the contractile ability of myocardium and the tolerance~     against ischemia-reperfusion and that activators of AMP-protein kinase such as atorvastatin~     and AICAR reverse this unwanted effect of sunitinib.~      Objectives:~      The primary objective of the study is to investigate the effect of sunitinib on ex-vivo~     atrial contractile force in absence and presence of ischemia-reperfusion.~      A secondary objective is to explore if atorvastatin or AICAR prevent sunitinib-induced~     deterioration of contractile function of human atrial trabeculas. Study design: Lab~   "
177122|NCT01246765|"~     The purpose of the National Pregnancy Registry for Atypical Antipsychotics is to determine~     the frequency of birth defects among infants exposed to atypical antipsychotics.~   "
177123|NCT01246752|"~     Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age~     in intermediate risk, after first complete response in comparison to standard consolidation~     chemotherapy~   "
177124|NCT01246739|"~     Incidental findings of adrenal tumours,incidentalomas, occur in 1-5 % in the general~     population and 10-25 % of these patients will exhibit biochemical mild hypercortisolism.~     Although the patients do not have clinical signs of classical Cushing's syndrome, they have~     an increased risk for hypertension, dyslipidemia, diabetes mellitus, osteoporosis and~     obesity.~      The hypothesis of the study is, that surgery of the adrenal adenoma responsible for the~     increased secretion of cortisol, will in part cure or ameliorate the metabolic syndrome.~   "
177125|NCT01246726|"~     This is a pilot study comparing the appearance and volume of the post surgical region in the~     intact breast, as determined by 3 modalities: computed Xray tomography (CT), 3 Dimensional~     ultrasound (USS), Magnetic resonance imaging (MRI) after breast conserving surgery and during~     whole breast irradiation.~   "
177126|NCT01246713|"~     The purpose of this study is to determine whether excipients in the liquid formulation of~     acetaminophen prevent the formation of the toxic metabolites of acetaminophen.~   "
177127|NCT01246700|"~     The purpose of this study is 1.) to determine if sensory attention focused exercise is an~     effective management strategy for Parkinson's disease, and 2.) to identify if the benefits~     are a result of strength gains.~   "
177128|NCT01246687|"~     The Internet holds promise for a wide-scale promotion of dietary and lifestyle behavioural~     change. Website-delivered interventions have a potentially broad population reach as it is~     available 24 hours, and could be hosted by both government and non-governmental agencies. To~     date, there is no published study focused on dietary behaviour change in adults with Type 2~     Diabetes Mellitus (T2DM) via a website-based system.~      myDIDeA was a 12-months two-armed randomised controlled trial conducted in three tertiary~     public hospitals in Klang Valley, Malaysia. The primary outcome was the Dietary Knowledge,~     Attitude and Behaviour (DKAB) score, while the secondary outcomes included the food intake,~     anthropometry measurements, blood pressure and resting heart rate, blood biomarkers and the~     Dietary Stages of Change (DSOC) score.~   "
177129|NCT01246674|"~     By this study the investigators wish to (1) quantify hip strength and functional-performance~     deficits at discharge after fast-track total hip arthroplasty (THA), and (2) investigate if~     changes in thigh circumferences, or hip pain are correlated to changes in hip strength and~     functional-performance after fast-track THA.~   "
177161|NCT01246258|"~     The purpose of this study is to determine whether patients with primary ciliary dyskinesia~     (PCD) have reduced or absent otolith function.The otolith system is a specific part of the~     inner ear vestibular (balance) system that detects linear movement.~   "
177134|NCT01246609|"~     Background:~      There are several surgical procedures in which irrigation fluids are used to enable vision~     and treatment in body cavities, such as hysteroscopy, arthroscopy and cystoscopy. Several~     solutions are used for irrigation: normal saline, glycin, mannitol, sorbitol and others.~     Post-operative complications, as visual disturbances, confusion and other neurologic symptoms~     were attributed to irrigation fluid absorption, water intoxication and hyponatremia, and are~     refered to as TURP syndrome when appearing following transurethral prostatectomy (TURP).~     Historically, a reduced serum sodium concentration has been used to diagnose absorption of~     electrolytes-free irrigating fluid during urologic procedures. However, neurologic symptoms~     following transurethral prostatectomy (TURP) do not correlate with blood sodium level,~     moreover, Hyponatremia may not be the sole or even the primary cause of the neurological~     manifestations of TURP syndrome. Other techniques were suggested for evaluating the volume of~     irrigation solution absorption though none is used routinely in the clinical setting.~      Percutaneous Lithotripsy (PCNL) is a procedure used to treat patients with nephrolithiasis.~     In this procedure irrigation fluid is administered into the kidney and urinary tract~     collecting system. The solution used is normal saline. In earlier studies there was no~     evidence for absorption of the irrigation fluids, though medical literature on this issue is~     limited. However, minute changes in electrolytes and acid-base balance may indicate the~     opposite is true. Indeed, the volume of irrigation and duration of the procedure may have an~     effect as well. According to the investigators hypothesis, the change in Ph and reduction in~     base content in patients undergoing PCNL may be the result of irrigation fluid absorption,~     since chloride from the normal saline is known to cause such effect.~      Methods This is an observational prospective study of consecutive 200 adult patients~     undergoing elective surgery of PCNL in the investigators operating rooms.~      The investigators will collect data that is taken from the patient's file and routine~     management of these patients: age, gender, weight, pre-operative blood tests including:~     electrolytes, creatinine, hematocrit, ph, bicarbonate, base, length of the procedure, volume~     and type of irrigation fluids used, volume and type of intravenous fluids used.~     Post-operative blood tests will be recorded.~      The investigators will compare pre and post-operative blood tests, especially ph,~     bicarbonate, base content, sodium. The investigators will analyse statistically the~     correlation between the change of each parameter (delta X) and the volume of irrigation~     fluids used during the surgery.~   "
177135|NCT01246596|"~     The etiopathogenesis of periodontal disease results from complex interaction between~     infectious agents, mainly including bacteria, and host cellular and humoral immune responses.~     However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain~     all biological and clinical features of the destructive periodontal disease. The main~     hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by~     altering epithelial gingival cell biology and consequently may promote the initiation and~     progression of periodontitis.~   "
177136|NCT01246583|"~     The study is being conducted to see whether CP-690,550 ointment has potential as a safe and~     effective treatment for adult patients with mild to moderate chronic plaque psoriasis.~   "
177137|NCT01246570|"~     It is known that organized cardiac rehabilitation is effective in improving exercise capacity~     in coronary heart disease patients. Less is known about the long-term results after cardiac~     rehabilitation. Earlier studies have shown that many patients quit exercising when no longer~     attending formal rehabilitation. The investigators wish to investigate the effect of a~     maintenance program after ending a rehabilitation program, and to compare this to usual care.~     The investigators hypothesis is that the maintenance program will result in higher exercise~     capacity and more physical activity compared to usual care.~   "
177138|NCT01246557|"~     Despite certain notable progress, treatment of patients with Chronic Lymphatic Leukemia (CLL)~     is still disappointing. Although thanks to the use of treatment of (immune) chemotherapy,~     mainly based on fludarabine, rituximab and alemtuzumab, the rate of complete response (CR)~     has increased from minus 10% observed when clorambucil was the core of the therapy to a~     60-70%, with time all patients relapse and most of them die at the end due to the disease or~     to involvements related to the treatment. Progress when understanding the CLL biology have~     cleared a series of aspects: 1) there is a significant proportion of CLL cells actively~     copying themselves, contrary to the opinion that most of CLL cells are in G0 phase of the~     cell cycle; 2) Immune regulatory mechanism basically measured by T cells and NK cells have an~     important role in the continuous accumulation of CLL cells in the body; 3) Cells of the~     stroma are essential to maintain survival of CLL cells through a series of cytokines or~     chemokines. Under the light of this evidence, it is worth studying new treatment modes~     directed not only to CLL cells but also to the microenvironment and immune functions.~      Lenalidomide is being investigated as treatment for several oncologic indications including~     myelodysplastic syndromes, multiple myeloma and non-Hodgkin lymphoma. Within the scope of~     CLL, it has been proved that lenalidomide is active in patients with relapsing / treatment~     resistant CLL patients. Forty five patients with relapsing CLL, 51% resistant to fludarabine,~     where included in a phase II study and were treated orally with 25 mg of lenalidomide on days~     1 to 21 of a cycle of 28 days. The total response rate was of 47% with up to a 9% of complete~     responses.~      The combination of lenalidomide with dexamethasone is being investigated in multiple myeloma~     and has revealed as a highly efficient treatment in relapsing/ treatment resistant patients~     as well as in those newly diagnosed. Bearing in mind that both drugs, lenalidomide and~     dexamethasone, are clinically active in CLL the investigators have designed a study with this~     combination in relapsing or treatment resistant patients following treatments containing~     fludarabine which do not meet the requirements for an intensive rescue treatment.~      Given initial doses of 10 and 25 mg of lenalidomide daily may be associated with tumor lysis~     cases, it is proposed a low initial dose of lenalidomide in the first cycle 2.5mg., with~     further increases to prevent the occurrence of tumor lysis syndrome~   "
177139|NCT01246544|"~     In cooperation with INABBRA (Innovation Alliance Berlin-Brandenburg, Germany) the~     investigators would like to ask medical colleagues in the region to participate in an~     anonymous German online survey on patient safety.~      The investigators want to investigate the implementation and establishment of measures on~     patient safety, that anaesthesiologists utilize to fulfill their obligations.~   "
177140|NCT01246531|"~     Urinary lithiasis is a common disease on young adults, but not so far on aging people.~     Nowadays, the investigators are seeing a gradative growth on men above sixty years old,~     mainly in industrialized countries. The purpose of this study is to investigate metabolic~     aspects of aging men with renal stones, towards blood tests, 24 hour-urinary samples,~     imagenological exams and bone densitometry. The investigators have made a case-control model.~   "
177141|NCT01246518|"~     Onychomycosis is a fungal infection that affects fingernails and/or toenails.~      The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of~     patients with fungal infection of the toenails.~   "
177142|NCT01246505|"~     Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the~     lower extremities.~   "
177143|NCT01246492|"~     The purpose of this study is to determine whether the presece of the artificial sweeteners~     aspartame, saccharin and asceulfame-k affect the blood glucose responses to an orally~     incested glucose solution.~   "
177144|NCT01246479|"~     The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a~     pediatric population vaccinated in the parent study IC51-322.~   "
177145|NCT01246466|"~     The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac~     surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in~     treating AF, and how effective this combined procedure is using the AtriCure System in~     treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac~     surgery and a standard electrophysiology catheter, currently available, will be used to~     perform the catheter ablation procedure. This surgical procedure is considered less invasive~     because it is done through tiny surgical punctures on the sides of the chest near the ribs~     instead of one large surgical incision of the breast bone to completely open the chest and~     access the heart, and it also avoids the need for the heart-lung bypass machine.~   "
177146|NCT01246453|"~     1. Objectives:~             -  Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs~               urokinase in patients with complex complicated parapneumonic pleural effusion and~               empyema.~             -  To evaluate the pleural and plasmatic levels of the fibrinolytic system markers~               after the treatment with alteplase vs urokinase~             -  To evaluate the safety of alteplase in the treatment of complex complicated~               parapneumonic pleural effusion and empyema~        2. Design: Multicentric, randomized, parallel, controlled and double blind~        3. Main variable: Percentage of curation~        4. Study population and number of patients: 204 patients with complex complicated~          parapneumonic pleural effusions and empyema~        5. Duration of the treatment: Three days (main variable), and optional three days~          (secondary variable)~   "
177147|NCT01246440|"~     The purpose of this study is to evaluate the efficacy and safety of catumaxomab as~     consolidation treatment in patients with epithelial ovarian cancer in second or third~     complete remission.~   "
177148|NCT01246427|"~     The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in~     reducing hot flash scores after 4 weeks of treatment.~   "
177149|NCT01246414|"~     This study aims to compare the inflammatory mediators in exhaled breathe condensates from~     allergic and non-allergic asthmatic patients.~   "
177150|NCT01246401|"~     Specific Aim: To conduct a randomized, placebo-controlled trial of extended~     release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners~     meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are~     transitioning from the structure of a correctional setting to the community.~      Hypotheses:~      i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1 RNA~     levels, higher CD4 counts and higher rates of retention in care.~      ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to opioid~     relapse, lower addiction severity and lower craving for opioid.~      iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the~     control group.~      iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to~     the community.~   "
177151|NCT01246388|"~     The purpose of this study is to evaluate non-invasive parameters for staging and grading of~     chronic hepatopathy in comparison to liver biopsy.~   "
177152|NCT01246375|"~     The purpose of this research is to determine whether the prevalence of osteoporosis is~     greater in patients who suffer from Chronic obstructive pulmonary disease (COPD) or Asthma~     disease and uses inhaled steroids.~   "
177153|NCT01246362|"~     The purpose of this study is to study the efficacy of pre-emptive etoricoxib in reducing~     post-operative pain and improving function outcome after a total knee arthroplasty.~   "
177154|NCT01246349|"~     The investigators studied the effect of motivational interviewing (MI) on self-efficacy,~     health behaviors, and health outcomes in overweight children and adolescents (ages ranging~     from 10 to 18 years).~   "
177155|NCT01246336|"~     Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis~     and differential diagnosis are not yet available. Exhaled breath testing may yield a~     breath-print that can be used to distinguish healthy and diseased states.~   "
177156|NCT01246323|"~     The purpose of this study is to determine whether combined anesthesia will provide better~     pain control for the postoperative period following gynecological laparoscopy surgery.~   "
177157|NCT01246310|"~     Polycystic ovary syndrome (PCOS) is one of the most common reproductive disorders affecting~     5-10% of women of reproductive age. Beside impairments on reproductive functions~     (oligomenorrhea/amenorrhea), it also affects metabolism (insulin resistance, type 2 diabetes~     mellitus and cardiovascular risk) and psychology (increased anxiety, depression and eating~     disorders). Recently, several studies have shown that there is an increased risk of mood~     disorders in women with PCOS, with major depression and bipolar disorder as the most frequent~     diagnosis.~      Myo-inositol is classified as a member of the vitamin B complex and it works as a second~     messenger system of several neurotransmitter receptors; furthermore, inositol, when~     administrated at pharmacological doses, crosses the blood-brain barrier.~      Studies from the 90s showed that inositol, alone or in combination with other antidepressant~     drugs (mainly serotonin reuptake inhibitors), is able to induce improvement of the Hamilton~     depression rating Scale.~      Recently, inositol has been proposed as treatment to improve clinical, metabolic and~     endocrinal status in PCOS patients. Administration of myo-inositol to PCOs patients resulted~     in several beneficial effects, such as decrease of circulating insulin and serum total~     testosterone as well as a restored ovulation.~      In this proposed study, the investigators aim to evaluate in a double blind randomized trial~     whether inositol alone has beneficial effects on mental health disorders associated with~     PCOs. In particular, 60 women in reproductive age that will be diagnosed of PCOs, according~     to Rotterdam 2003 criteria, will be recruited and randomly assigned to the inositol or~     placebo group. Both groups will go through ultrasonic evaluation of the ovaries and serum~     hormonal levels (FSH, LH, testosterone, estradiol and insulin) will be evaluated.~     Furthermore, with the help of psychiatrics, patients will be interviewed in order to test the~     presence of any mental health disorders using validated tests such as: Hamilton Anxiety Scale~     (HAM-A), Hamilton Rating Scale for Depression (HAM-D), Health Assessment Questionnaire (HAQ),~     Short Form of Mc Gill Pain Questionnaire (SF-MPQ).~      Women assigned to the inositol group will receive 12g of inositol during the day in three~     different administrations for a period of 4weeks.~      At the end of treatment period patients will be interviewed by psychiatrics and will go~     through ultrasonic evaluation of the ovaries and hormonal levels will be tested~   "
177158|NCT01246297|"~     Patients who have surgery to cure lung cancer often have multiple problems at hospital~     discharge and later on. This includes poor exercise performance and quality of life,~     breathlessness, pain and tiredness. Currently there is little formal physical or~     psychological support for such patients. This pilot study aims to investigate whether~     outpatient pulmonary rehabilitation (an exercise training and education programme), started~     within 2 weeks of hospital discharge, can lead to improvements in exercise performance and~     quality of life in patients who have undergone lung cancer surgery. The study will also~     assess whether pulmonary rehabilitation is acceptable for patients and will analyze the~     safety profile. The hypothesis is that patients; discharged from hospital after undergoing~     lung cancer surgery, have improved exercise performance and quality of life following early~     outpatient pulmonary rehabilitation compared with usual care.~   "
177159|NCT01246284|"~     Alopecia areata (AA) is a disease characterized by areas of hair loss. Localized steroid~     injections is the standard treatment for limited disease. There are no existing studies that~     compare different concentrations of steroids in the treatment of AA. This study will compare~     the efficacy and safety of different concentrations of localized steroid injections in the~     treatment of AA. Six treatment sessions will be done over 6 to 9 months. The investigators~     will compare the following concentrations: 2,5mg/ml, 5mg/ml, 10mg/ml, and normal saline.~   "
177160|NCT01246271|"~     There is a concern about choosing adequate surgical options for stress urinary incontinence~     associated with vaginal prolapsed and still lack of evidence can be observed. In this study~     we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic~     organ prolapsed.~   "
177163|NCT01246232|"~     Schizophrenia is a mental health problem usually starting in the late teens/early twenties,~     and often lasting many years. The standard medication ('antipsychotics') for this problem is~     usually helpful, and if taken continually can keep people well, reducing the likelihood of~     further episodes. However, in up to one in three people with schizophrenia, the illness does~     not show much improvement with antipsychotic medication. For some of these 'resistant'~     illnesses, one particular antipsychotic, clozapine, can work well, but one disadvantage is~     the risk of a severe blood side effect which means that regular blood testing is necessary.~     If the response to clozapine treatment is disappointing, there is some evidence that adding~     another antipsychotic can sometimes produce more improvement. However, it seems that the~     added antipsychotic may need to be taken by the person for at least 10 weeks in order to work~     well. The investigators plan to test carefully the possible benefits and problems when the~     antipsychotic amisulpride or a dummy tablet ('placebo') is added to clozapine for 12 weeks in~     people whose schizophrenia illness has not been helped much by any antipsychotic medication~     on its own, and who are now taking clozapine, but again with not much improvement. The~     investigators have chosen amisulpride because its pharmacological action may be complementary~     to that of clozapine, and also it is less likely than some other antipsychotics to compound~     some of the characteristic side effects of clozapine, such as sedation, weight gain and other~     metabolic problems.~      Adjunctive amisulpride or placebo will be randomly assigned. The investigators expect that~     adding amisulpride will be more likely to cause an improvement than adding placebo. But the~     investigators should learn more about the risks and side effects of combining these two~     medications. Also, the investigators should gain a greater understanding of the possible~     benefits of adding another antipsychotic to clozapine in relation to particular problem~     symptoms, and a person's ability to live and work in the community.~   "
177164|NCT01246219|"~     The research aims to provide data on gender-related psychological impact of GH (Growth~     Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males~     are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the~     study, the investigators aim to provide descriptive documentation of the unique distress~     signal manifestation implicitly shown by Idiopathic Short Stature (ISS) boys and suggest~     methods of early detection and measurement of such manifestations that can be used to cement~     guidelines for the treatment in GH.~   "
177165|NCT01246206|"~     The primary goal of the study is to determine the incidence and severity of acute Graft~     versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor~     Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the~     combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will~     determine the safety of this combination in the first six months post transplant.~      Secondary goals include determining the time to recovery of white blood cells and platelets~     (engraftment), determining the occurrence of opportunistic infections, defined as infection~     that occurs in people with weakened immune systems and caused by organisms that do not~     normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral~     infections), estimating the incidence of chronic GVHD at two years and the overall and~     disease free survival at two years.~      Immune response will be assessed by means of immuno-correlative studies both prior to and at~     various points after transplant.~   "
177166|NCT01246193|"~     The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed~     Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.~   "
177167|NCT01246180|"~     Pressure ulcers are a common and costly problem. Advancing the understanding regarding the~     basic pathophysiological mechanisms mediating the development of pressure ulcers will allow~     for better delineation of populations at risk.~      Healthy skin is protected from pressure-induced ischemic damage because of the presence of~     pressure-induced vasodilation (PIV). In contrast, in absence of PIV, such as in diabetic~     patients or older subjects with sensory neuropathy, the skin is exposed to severe cutaneous~     ischemia, which could lead to pressure ulcer formation.~      Since Acid Sensing Ion channels (ASICs) appear to be involved in the cutaneous~     mechanosensitivity, the investigators hypothesized that PIV could be altered by treatments~     that block ASICs.~   "
177168|NCT01246167|"~     This trial is designed to compare head-to-head conservative with operative treatment in 2~     stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and~     operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented fractures~     (MFF) meaning 3 and 4 part fractures, the comparison is between conservative treatment,~     operative treatment with Philos plate and operative treatment with Epoca prosthesis. Subgroup~     analysis will be performed in an effort to obtain limit values for specific treatment of~     different age and fracture groups. A cost-effectiveness analysis and comparison between~     different treatment modalities will be carried out. The primary outcome measure will be the~     DASH score and the secondary outcome measure the EQ-5D value. Recruitment period is 3 years~     and follow-up 2 years.~   "
177169|NCT01246154|"~     To evaluate exercise tolerance.~   "
177170|NCT01246141|"~     Functional tricuspid regurgitation is common in patients with heart valve disease,~     replacement and repair both can correct this anomaly. However, there is no data to address~     which one can bring more benefits to these patients with combined heart valve disease. The~     investigators retrospectively review patients with two or more heart valve disease and~     functional tricuspid regurgitation, and assess its long term outcomes.~   "
177171|NCT01246128|"~     Background:~      - Previous studies have suggested that smoking cigarettes affects the number of receptors in~     the brain for nicotine, a chemical present in cigarette smoke. The receptors play a role in~     an individual's ability to think and concentrate. Many people with schizophrenia and similar~     disorders smoke, and research suggests that smoking may temporarily improve concentration and~     focus in individuals with schizophrenia. Researchers are interested in studying both current~     smokers and nonsmokers with schizophrenia to determine whether smoking affects the number of~     nicotine receptors in the brains of people with schizophrenia.~      Objectives:~      - To study the distribution and volume of nicotine receptors in the brains of individuals~     with schizophrenia who are either nonsmokers or current smokers.~      Eligibility:~        -  Individuals between 18 and 50 years of age who have been diagnosed with schizophrenia~          and are either nonsmokers or current smokers (at least 10 cigarettes per day for the~          past year).~        -  Current smokers must be able to give up smoking for 48 hours.~      Design:~        -  This study involves an initial screening visit and up to five study visits.~        -  After the screening visit, participants will have two sessions in which they will~          complete questionnaires about thoughts, memory, and smoking habits. Smokers will also~          have nicotine blood and carbon monoxide breath levels taken during these sessions,~          before and after smoking a cigarette.~        -  Participants will have sessions with imaging studies (e.g., magnetic resonance imaging)~          to provide baseline measurements for later tests, and will also have tests to measure~          brain electrical activity.~        -  Participants will have a positron emission tomography (PET) scanning session to examine~          the nicotine receptors in the brain. Participants will need to stay overnight~          (nonsmokers) or for 2 nights (smokers) as an inpatient before the session. The PET scan~          session will take up to 6 hours, although participants will only be in the scanner for~          up to 3 hours.~        -  Participants will have a follow-up phone call with study researchers 1 week after the~          PET scanning session.~   "
177209|NCT01245621|"~     ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care~     intervention designed to improve quality of life, mood, and symptom management for patients~     with an advanced stage cancer and their caregivers.~      The primary aims of this clinical trial are to determine whether a palliative care~     intervention (introduced immediately or 12 weeks after diagnosis) can improve survival,~     quality of life, mood, symptom intensity and end-of-life care.~   "
177172|NCT01246102|"~     Background:~      - The experimental drug AT13387 has been shown to have some anticancer effects against tumor~     cells by blocking a protein that affects other proteins inside certain cancer cells, and~     helps to prevent the cancer cells from reproducing and spreading. AT13387 has not been tested~     in humans, and researchers are interested in investigating whether it can be used to treat~     solid tumors that have not responded to standard treatments.~      Objectives:~      - To investigate the safety and effectiveness of AT13387 in individuals with solid tumors.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors that have not responded to~     standard treatments.~      Design:~        -  Participants will be screened with a physical examination and medical history, as well~          as blood tests and tumor imaging studies.~        -  AT13387 will be given in 28-day cycles of treatment. Participants will receive AT13387~          twice a week (2 days in a row) for the first 3 weeks of the cycle, followed by a fourth~          week without the drug.~        -  Participants will have regular blood and urine samples, imaging studies, eye~          examinations, and tumor biopsies to monitor the effects of the treatment.~        -  Participants will continue treatment with AT13387 unless serious side effects develop or~          the tumor stops responding to treatment.~   "
177173|NCT01246089|"~     The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal~     injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).~   "
177174|NCT01246076|"~     The purpose of this study is to determine the proportion of confirmed responses (complete~     response, partial response, and hematologic improvement as defined by revised IWG criteria~     during the 12 months of treatment.~   "
177175|NCT01246063|"~     The aim of this phase I/II trial is to determine the maximal tolerated dose (MTD) of~     carfilzomib together with pegylated liposomal doxorubicin hydrochloride (PLD) with or without~     dexamethasone, and then to establish the efficacy and safety of this novel combination in~     patients with relapsed or refractory multiple myeloma~   "
177176|NCT01246050|"~     The aim of this study is to serve as a pilot showing the feasibility of a Hub and Satellite~     Heart Failure (HF) Provider's Network which will aim to provide improved, evidence-based care~     to veterans with HF. Primary Care Providers in the VA Community Based Outpatient Clinics will~     undergo a brief period of intensive training in HF management and then practice in a network~     of primary care providers supported by the Regional HF Center.~   "
177177|NCT01246037|"~     The main question of this study is: 'Is selective beta-blocker treatment safe and effective~     in reducing sympathetic overdrive, thereby improving RV function and remodeling in patients~     with iPAH?'.~      In addition to the determination of RVEF, the investigators will explore how beta-blocker~     therapy affects sympathetic overdrive, remodeling of the RV, single beat elastance, exercise~     capacity and mechanical efficiency.~      30 iPAH patients will be randomized to either Bisoprolol- or placebo-treatment in a~     double-blinded fashion. A cross-over trial design will be used to increase the power of the~     study and to assess long-term effects of Bisoprolol-treatment and -withdrawal. The medication~     will be given in an escalating dose regimen (as described in the 'farmacotherapeutisch~     kompas', www.fk.cvz.nl) and treatment will be monitored along the guidelines of the American~     Heart Association.~   "
177178|NCT01246024|"~     To investigate the influence of induced hypoxia on the ERG.~   "
177179|NCT01246011|"~     Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just~     undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive~     antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be~     randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result~     and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with~     a negative antibody result will also be followed in the study. All subjects will have a~     cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery~     bypass vein grafts. This study will evaluate if treating patients who have heparin PF4~     antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of~     coronary artery bypass vein grafts.~   "
177180|NCT01245998|"~     The aim of the study is to establish whether treatment of superficial vein thrombosis (SVT)~     with low-molecular-weight heparin in preventive or therapeutic doses prevents disease~     progression and thromboembolic events (deep vein thrombosis and pulmonary embolism), whether~     efficacy of low-molecular-weight heparin differs with regard to the dosage used (prevention,~     treatment), and to recognize groups of patients in which treatment with heparin is most~     efficient, as well as to determine factors that influence the efficacy of SVT treatment with~     heparin.~   "
177181|NCT01245985|"~     TPF-C-HIT investigates the combination of induction chemotherapy with TPF followed by~     radioimmunotherapy with cetuximab and IMRT plus carbon ion boost with regard to efficacy and~     toxicity of the combination regimen.~   "
177182|NCT01245972|"~     This is a research study to find out more about the use of the pulsed dye laser in the~     treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not~     invaded deep into the skin. The purpose of this study is to determine whether the use of the~     pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage~     squamous cell carcinoma.~      Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that~     have a prominent blood vessel component. It has been used to treat broken blood vessels on~     the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions~     with a prominent vascular component.~   "
177183|NCT01245959|"~     The purpose of this study is to compare induction chemotherapy~     (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent~     chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in~     order to confirm the value of induction chemotherapy in NPC patients.~   "
177207|NCT01245647|"~     The purpose of the study is to find out if a medication,naltrexone is helpful for~     HIV-infected women who sometimes drink too much. The study will try to find out whether women~     like the medication, whether the medication helps them cut back on their drinking, and~     whether it helps improve their overall health. Naltrexone has not been used widely among~     people who are engaged in less severe drinking and in primary health care settings.~     Therefore, the investigators would like to determine whether it is helpful among women who~     sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The investigators~     hypothesize that by taking naltrexone, women with hazardous drinking pattern will reduce~     their drinking which in turn will improve their medication adherence, improve their health~     and quality of life.~   "
177184|NCT01245946|"~     -  Acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens~          and some people may continue throughout adulthood.~        -  Topical retinoids related to oral antibiotics are considered first-line treatment of~          moderate inflammatory acne.~        -  Recently, photodynamic therapy (PDT) with a photosensitizer, 5-aminolevulinic acid (ALA)~          or methyl aminolevulinate (MAL), has proven useful in the management of inflammatory~          acne. Although progress has been made in the study of photodynamic therapy for acne, to~          date, no study has compared PDT with standard and well-validated pharmaceutical~          treatments and with the current recommended therapy for most types of acne combination~          therapy with a topical retinoid plus one or more antimicrobial agents.~      Hypothesis~        -  PDT with the photosensitizer ALA will be effective and safe for the treatment of~          moderate facial inflammatory acne.~        -  The ALA-PDT is more effective than conventional therapy with oral antibiotics and~          topical retinoids in the treatment of moderate inflammatory acne with faster action at~          12 weeks of follow-up.~   "
177185|NCT01245933|"~     The purpose of this study is to determine the prevalence and severity of extrapulmonary~     disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and~     mortality of COPD patients.~      Furthermore the investigators evaluate the relationship between systemic inflammation and~     organ involvement.~   "
177186|NCT01245920|"~     This randomized clinical trial will involve at least 25 patients who have selected to receive~     a dental implant to replace a missing tooth. One group will receive the test treatment of a~     bone graft and a dissolvable membrane at the outer surface of the dental, while the control~     group will not receive the bone graft and membrane adjacent to the implant.~      The following will be measured: bone thickness and height adjacent to implant, inflammation~     of gum tissue, recession of gum tissue, bleeding, pocket depth, and implant success. Patients~     will be followed for 1 year, including evaluation time points at 2 weeks, 1 month, 3 and 6~     months, and 1 year. Statistical analysis of the data will be conducted.~      The hypothesis is that there is no difference with regard to bone thickness, bone height,~     pocket depth, bleeding, and implant success rate for grafted implant sites compared to~     non-grafted implant sites.~   "
177187|NCT01245907|"~     The aim is to evaluate effects of internet-based applied relaxation (a simplified version of~     cognitive behavioral therapy) for women with menopausal symptoms mainly vasomotoric symptom~     (VMS), i.e. hot flashes and sweating. Sixty postmenopausal women with VMS will be recruited~     and 30 randomized to applied relaxation (AR) via internet and 30 to a control group which is~     a non-treated waitlist group.~      At baseline, after 10 weeks of therapy and six, 12 and 24 months after end of therapy women~     will be asked to fill in diaries about hot flashes and answer questionnaires on Quality of~     Life (Women's Health Questionnaire; WHQ, anxiety and depression measured with Hospital~     Anxiety and Depression Scale; HADS and one measuring sleep, Insomnia Severity Index; ISI as~     well as one about knowledge of the climacteric and hormone therapy).~      The waiting list group will be offered internet based AR after 10 weeks with the same~     follow-up as the treatment group.~   "
177188|NCT01245894|"~     The aim of this study was to measure the effect of low- and high-dose lipid-lowering~     treatment with rosuvastatin on the coronary physiology parameters.~   "
177189|NCT01245881|"~     In several observational studies, non-ablative fractional photothermolysis (FP) has been~     reported to bridge the gap between efficacy and tolerability in the treatment of melasma.~     While some beneficial effects have been attributed to non-ablative FP in treating melasma,~     methodological constraints (e.g., a limited number of patients; no control group assignment)~     impair efficacy assessment; currently published results neither allow researchers and~     clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular,~     bias resulting from poorly designed trials may mislead clinicians into making a wrong~     decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side~     effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and~     safety of FP in the treatment of melasma as compared to the lone application of a~     sun-blocking lotion (SPF >50).~   "
177190|NCT01245868|"~     The purpose of the study is to investigate if a small amount of lignocaine added to~     bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can~     shorten the duration of the sensoric and the motoric blockade.~   "
177191|NCT01245855|"~     we hypothesized that periprocedural treatment with intravenous lipo-PGE1 may reduce~     myocardial injury and improve clinical outcomes in patients undergoing PCI.~   "
177192|NCT01245842|"~     The purpose of this study is to evaluate the effect of a hand exercise intervention on~     function and osteoarthritis symptoms in persons with hand osteoarthritis .~   "
177193|NCT01245829|"~     Sepsis contributes to nearly 20% of all hospital deaths and is the leading cause of death on~     non-coronary intensive care units. Contamination of the patient environment is common with~     organisms such as MRSA, VRE and C.difficile remaining viable for days or weeks on a variety~     materials and surfaces. Up to 90% of patient notes and charts on critical care may be~     contaminated with potential pathogens including MRSA and it has been shown that healthcare~     workers may contaminate hospital paperwork with organisms originating from patients. Cellomed~     is a triclosan based laminate which has been shown to possess antimicrobial activity against~     MRSA, E.Coli, Enterococcus, Stenotrophomonas and Klebsiella. The study presented for~     consideration aims to compare levels of contamination between critical care observation~     charts coated with either a 'standard' matt or antimicrobial Cellomed laminate. It is~     proposed that paperwork laminated with Cellomed may exhibit reduced levels of contamination~     and decrease the potential for cross infection on critical care and potentially other areas~     of the hospital in which clinical paperwork is handled.~   "
177194|NCT01245816|"~     The purpose of this phase III study is to evaluate the safety and efficacy of the combination~     of eflornithine and sulindac compared to single agent sulindac or eflornithine in reducing~     the number of polyps in patients with familial adenomatous polyposis (FAP).~   "
177195|NCT01245803|"~     Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI~   "
177196|NCT01245790|"~     A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects~     with impaired kidney (renal) function compared with healthy volunteers with normal renal~     function. Stage 1 will include healthy subjects and subjects with end stage renal disease,~     while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment~     dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in~     subjects with renal impairment.~   "
177197|NCT01245777|"~     In pregnancy Restless Legs Syndrome(RLS) is more common than in the general population.~     During pregnancy iron tablets are the only available safe medication but their efficacy is~     rather poor. It is the aim of this study to examine the efficacy, practicability and safety~     of the drug Ferinject® containing the active agent Ferric carboxymaltose for the therapy of~     Restless Legs Syndrome(RLS) during pregnancy in the case of iron deficiency or anaemia.~      20 women with RLS and iron deficiency and/ or anaemia in the third trimester of pregnancy~     will receive intravenous Ferric carboxymaltose in one or two single doses. Repeated blood~     tests, pre-and post-therapy actigraphy as well as repeated answering of questionnaires~     concerning Restless Legs Syndrome(RLS)-symptoms and sleep quality will show the effect of~     iv-Iron supplementation on Restless Legs Syndrome(RLS)-symptoms during pregnancy.~        -  Trial with medicinal product~   "
177198|NCT01245764|"~     The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose~     regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in~     Sub-Saharan Africa. Data from the current study are needed in order to complement existing~     extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™~     may be administered safely and will induce immune responses in populations from and living in~     Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.~   "
177199|NCT01245751|"~     This study was conducted to obtain safety and immunogenicity data after a booster dose of~     Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was~     compared to similar information obtained after Zoster Vaccine, Live administration to~     age-matched and younger participants who received their first dose of Zoster Vaccine, Live.~     The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in~     participants ≥70 years of age induces an antibody response that is noninferior to that of a~     first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose~     of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus~     (VZV) antibodies.~   "
177200|NCT01245738|"~     The current study is proposed to investigate the pattern of dyslipidemia and of lipid~     treatment practices in patients in India experiencing their first acute cardiovascular event~     and the extent of residual dyslipidemia after 12 weeks of treatment with statins.~     Dyslipidemia definitions are per the National Cholesterol Education Program - Adult Treatment~     Panel III (NCEP-ATP III).~   "
177201|NCT01245725|"~     The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i.v.~     bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention~     (PCI) plus two hours after the procedure) is more effective than placebo in the setting of~     standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or~     bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac~     ischemic events defined as death, myocardial infarction (MI), and urgent target vessel~     revascularization (uTVR) within 48 hours following study drug initiation.~      A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i.v. bolus~     followed by a 0.15mcg/kg/min i.v. infusion during a PCI plus two hours after the procedure)~     is safe compared to placebo in the setting of standard therapies (e.g. aspirin, a~     thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as~     assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following~     study drug initiation.~      Patient enrollment is pending.~   "
177202|NCT01245712|"~     The goal of this clinical research study is to find out if receiving a 1-week course of~     partial breast irradiation (PBI) using proton therapy will cause fewer and/or less severe~     side effects (such as changes to the appearance of the breast) than a longer course of~     radiation treatment.~      This is an investigational study. Proton radiation therapy is FDA approved and commercially~     available for breast cancer. Up to 200 women will take part in the study. All will be~     enrolled at MD Anderson.~   "
177203|NCT01245699|"~     The investigators will quantify the quality of chest compressions provided in the Emergency~     Department and determine whether the quality of chest compressions is related to patient~     outcome. The quality of chest compressions and patient outcomes will be assessed both before~     and after the introduction of audiovisual feedback in real time.~   "
177204|NCT01245686|"~     Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of~     death in the US. Every year, more than one million Americans have a heart attack, and nearly~     800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than~     $316 billion in health care and lost productivity.~      Both lifestyle changes and medication can reduce the risk of CVD, and this project combines~     these approaches in the hopes of identifying a practical intervention for use in primary care~     medical offices. The project combines two previously tested interventions and updates them to~     meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs~     (statins).~      The research team is delivering the combined intervention in two formats: web-based and~     counselor-based. Each format has the same content, but the web-based advice is accessed~     through the Internet by clients at home, a community site, or a primary care office. The~     other format involves sessions delivered to clients by a counselor either in person at a~     primary care office or over the telephone. The researchers will compare how effective each~     format is in reducing participants' risk of coronary heart disease. They will also determine~     the interventions' effect on participants' diet, physical activity, smoking status,~     medication adherence, and other health indicators. In addition, the team will compare the two~     formats' cost-effectiveness and how well the patients, office staff, and clinicians accept~     the interventions.~      Recruited from five family practices, 600 patients representing the geographic and ethnic~     diversity of North Carolina are taking part in this study. Half the participants are randomly~     assigned to the web-based intervention; the other half to the counselor-based version. Both~     groups will also get information on local resources, such as gyms and farmers markets, that~     can help participants maintain a healthy lifestyle.~   "
177205|NCT01245673|"~     One purpose of this study is to find out if a new combination of immune system treatments~     (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection~     (immunity) against the myeloma cells. A second purpose is to find out how well this~     combination of immune system treatments is able to control the myeloma.~   "
177206|NCT01245660|"~     Modification of the EGF signalling pathway and / or HER 2, by Lapatinib in bladder cancer.~   "
177208|NCT01245634|"~     This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety~     of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing~     elective or urgent coronary artery bypass (CABG) surgery. Patients will be randomized to~     receive either RO4905417 20 mg/kg by intravenous infusion or placebo every 4 weeks for 32~     weeks.~   "
177271|NCT01244776|"~     This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular~     corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.~   "
177210|NCT01245608|"~     The primary purpose of this study is to determine the effects of a fixed dose combination of~     valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of~     cardiovascular events in adults older than 50.~      Various liver-related variables will also be recorded which will allow studying the effects~     of PolyPill on the liver and the effect of liver diseases such as nonalcoholic~     steatohepatitis on cardiovascular events and the protective effect of PolyPill.~   "
177211|NCT01245595|"~     Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass~     (the heart-lung machine). Approximately 35 to 50% of these children will have acute kidney~     injury, or damage to the kidneys, after the procedure. We currently have few medications to~     prevent this kidney injury. The hypothesis of this study is that giving aminophylline after~     heart surgery can decrease the acute kidney injury.~   "
177212|NCT01245582|"~     Primary Objective:~      - To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to~     sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to~     prolong overall survival (OS) for advanced HCC patients.~      Secondary Objective:~        -  To compare the efficacy of SECOX regimen with Sorafenib alone for progression free~          survival (PFS)~        -  To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR)~        -  To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone~   "
177213|NCT01245569|"~     The purpose of the present study is to determine the effects on health status and spirometric~     values of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.),~     over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.~   "
177214|NCT01245556|"~     The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in~     combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when~     administered in combination with ipilimumab.~   "
177215|NCT01245543|"~     AC480IV will be administered as a monotherapy and then in combination with docetaxel in~     patients with locally advanced or metastatic solid tumors for whom there are no standard or~     curative therapies available. It is designed to evaluate the safety and pharmacokinetic~     parameters of AC480IV as monotherapy and also in combination with docetaxel under the~     conditions of the study.~   "
177216|NCT01245530|"~     The purpose of this study is to evaluate the efficacy and safety of two fixed dose~     (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil~     for treatment for patients with Alzheimer type dementia.~   "
177217|NCT01245517|"~     Aim:~      Dietary Phosphorus Education Program can improve patients' knowledge, attitude and behavior~     of phosphorus restriction diet to reduce the risk of hyperphosphatemia and malnutrition of~     hemodialysis patients.~      Inclusion criteria:~      The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at~     baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin < 4.0~     mg/dL, or serum phosphate > 5.0 mg/dL, are eligible for inclusion.~      Subjects will be enrolled into this trial after signed informed consent. We expect to recruit~     60 subjects. Patients will be excluded if they had liver cirrhosis, malignant tumor, can't~     finish all education sessions and/or can't complete dietary records monthly. We will recruit~     a control group into this trial, they are eligible for inclusion but don't want to~     participant education sessions.~      Intervention protocol:~      At baseline, the investigators collect demography and pre-test KAP questionnaires among all~     subjects. If subjects were illiterate then investigator will conduct face-to-face interview~     and record their answers. Dietary Phosphorus Education is a 6-month program and be~     implemented by dietitians and investigators, including education, nutritional counseling and~     dietary records monthly.~      The first month was intensive weekly education sessions, each 20 to 30 minutes. Second and~     third month were monthly education sessions, each 20 to 30 minutes. There are total 6~     sessions in this trial. The last 3 months will follow-up periods, will collect anthropometry~     data monthly, biochemistry measurements and 3-day dietary records among all subjects. If~     subjects were illiterate then investigator will conduct face-to-face interview or~     phone-interview to complete each dietary record. Investigator collect post-test KAP~     questionnaires, diet behavior questionnaires and satisfaction questionnaires from subjects in~     the end of the trial,. If subjects are illiterate then investigators interview subjects and~     record.~      This is a 6-months trial and retrospective study to collect anthropometry, biochemical~     measurements and 3-day dietary records from control subjects monthly.~   "
177218|NCT01245504|"~     Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may~     be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may~     require more work by prosthetists to redesign the socket. The aim of this research is to~     assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination~     of how and where manufacturing errors occur will contribute to better quality of socket fit~     for the amputee patient and improve the efficiency of prosthetists who fit the manufactured~     products to their patients.~      Computer manufactured sockets are made for subjects, then their fits assessed by research~     practitioners.~   "
177219|NCT01245491|"~     The purpose of this study is:~        1. To study the effect of whole-body vibration on partial pressure of oxygen in arterial~          blood (PaO2), under hypobaric hypoxic conditions.~        2. To study the effects of whole-body vibration and hypobaric hypoxia on visual contrast~          sensitivity.~        3. To se if there is an increase in cytokines and other biomarkers under different~          hypobaric hypoxic conditions Our main hypothesis is that whole-body vibration may cause~          PaO2 to drop to a lower level, at a given altitude; than would be the case if there were~          no vibration present.~   "
177220|NCT01245478|"~     This will be a retrospective chart review of 200 charts of adult patients who have undergone~     a revision TKA at New England Baptist Hospital and who received implant component(s)~     manufactured by DePuy Orthopedics. The data will be collected retrospectively after patients~     are seen clinically for a minimum of five years after surgery to answer:~        1. What is the five-year survivorship of revision a knee prosthesis containing components~          manufactured by DePuy Orthopedics among adult revision TKA patients?~        2. What patient factors are associated with the need for re-operation after revision TKA~          among patients receiving DePuy implant components? How do clinical outcomes change from~          baseline over the five-year follow-up after revision TKA surgery?~      Data collection will include patient-reported and clinician-reported measures.~   "
177221|NCT01245465|"~     In this study the investigators aim was to investigate the safety and possible efficacy of~     Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the~     usefulness of a new online daily symptom registration system.~   "
177222|NCT01245452|"~     To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in~     early RA patients treated with tocilizumab compared to Methotrexate alone.~      The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population and~     correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety~     profile of Tocilizumab.~   "
177272|NCT01244763|"~     The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the~     correction of anemia in non-dialysis chronic kidney disease patients.~   "
177223|NCT01245439|"~     This open-label study will evaluate the safety, tolerability and efficacy of~     RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid~     arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current~     non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous~     infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment~     is 24 weeks.~   "
177224|NCT01245426|"~     This is a randomised, double-blind, placebo-controlled, parallel group study to determine the~     efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory~     volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X~     and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the~     original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once~     daily or 3mg GW870086X once daily.~   "
177225|NCT01245413|"~     Aim~      The aim of the Athena project is to develop an ostomy product that is softer and more~     flexible in order to improve the comfort for people with a stoma.~      The present investigation aims at testing how well the new Athena base plate adhere to~     perspiring skin both with and without mechanical exposure (cycling) since the ability to~     adhere under normal daily activity is an important quality for Coloplast products.~      Success criteria:~      The investigation is an explorative investigation where the adherence of Athena on perspiring~     skin is evaluated. Due to the explorative nature of the study it has not been possible to~     define specific success criteria up front. However, the adherence qualities of Athena may not~     be significantly reduced compared to SenSura.~      Design:~      Two groups of men, one group with a colostomy and one group without a colostomy, are~     included. The men should be cardiovascular fit, be able to cycle for 1 hour at moderate~     intensity and with Athena and SenSura base plates applied on the back and stomach. The~     adhesion of the base plates are tested before and after the physical activities.~      Population:~      The population consists of two groups. Group A: Men in the age of 50-70 without a stoma who~     have volunteered. Group B: Men with a colostomy who have volunteered. Both groups should be~     cardiovascular fit (cardio investigated), and be willing to cycle for 1 hour at moderate~     intensity on an exercise bike.~      The Athena test products are non-CE marked, non-sterile, 1-piece ostomy products with a flat~     custom cut base plate, a closed bag size midi or maxi with the intended use of collecting~     faeces from the colostomy. The comparator product is a Coloplast SenSura, 1-piece ostomy~     product with a closed bag. SenSura is CE-marked and launched on the market.~   "
177226|NCT01245400|"~     The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational~     Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to~     Allograft.~   "
177227|NCT01245387|"~     Long-term observational study to assess the safety, efficacy and quality of life of patients~     with neovascular age-related macular degeneration (AMD) under Macugen treatment.~   "
177228|NCT01245374|"~     This study is conducted in Europe. The aim of this study is to compare the easiness of use of~     Norditropin NordiFlex® device to the device previously used by patients or parents.~   "
177229|NCT01245361|"~     Patient with undifferentiated arthritis and the presence of anti-citruline (anti-CCP)~     antibodies are at high risk to develop RA. The presence of anti-CCP is associated with a~     higher rate of erosion and a higher risk of progressive and severe RA.~      The investigators have demonstrated in the CIERA study that MTX/IFX combination therapy is~     superior to MTX alone to reduce MRI signs of synovitis and bone edema and is clinically more~     effective.~      The immunopathogenesis of undifferentiated arthritis is poorly understood. However, synovial~     studies from patients with early arthritis suggest that UA and RA may share common~     immunopathogenic mechanisms. One biopsy study of asymptomatic joints in patients with early~     arthritis demonstrates synovitis in more than half of the joints samples with prominent T~     cell and macrophage infiltration, similar to Rheumatoid Arthritis (RA).~      Thus intensive treatment with anti-TNF antibodies (infliximab) may have an impact on multiple~     immune mechanisms driving synovitis in undifferentiated arthritis and may influence the~     clinical outcome.~      Recently, Methotrexate has been demonstrated to improve the course of undifferentiated~     arthritis and prevent the development of RA. Short regimen of more intensive therapy with~     Infliximab could alter the radiological, immunopathological and clinical outcome.~   "
177230|NCT01245348|"~     The purpose of this study is to validate that SULT4A1-1 status stratification improves~     responses to atypical antipsychotics in schizophrenia and to extend these findings into~     bipolar disorder.~   "
177231|NCT01245335|"~     Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed~     for proper function. This severe lack of blood flow can lead to painful legs while walking or~     at rest and can result in foot sores, ulcers, gangrene, and even amputation. The purpose of~     this study is to determine if injections of concentrated bone marrow into damaged tissues~     will result in improved blood flow. If successful, this treatment could improve blood flow to~     the lower limb, reduce pain, and reduce the frequency of limb amputations.~   "
177232|NCT01245322|"~     The primary objectives of this study were to characterize lactobacilli of human vaginal~     origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis,~     together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore,~     to investigate factors that could influence relapse.~   "
177233|NCT01245309|"~     Scratching the linning of the womb before IVF cycle could increase the chances of having a~     baby after an IVF cycle.~   "
177234|NCT01245296|"~     Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by~     increasing the infant's iron endowment at birth. Compared with early clamping, a delay of~     around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight.~      The results of previous intervention studies on delayed clamping are mixed, and few followed~     up infants beyond the perinatal period. All longer follow up studies have been performed in~     low income countries. The main objectives, therefore, was to assess whether delayed cord~     clamping improves hematological and iron status at 4 respective 12 months of age in a large~     sample of full-term, Swedish infants.~      The investigators also choose to investigate if the timing of clamping the umbilical cord~     could affect rate of infections during the first four months of life and to assess the~     infants development at 4 and 12 months of age.~   "
177235|NCT01245283|"~     The purpose of this study is to determine if a 4 month resistance exercise program can reduce~     knee osteoarthritis pain functional impairment and cartilage turnover.~   "
177236|NCT01245270|"~     Dietary strategies for alleviating health complications associated with type 2 diabetes (T2D)~     are being pursued as alternatives to pharmaceutical interventions. Berries such as bilberries~     that are rich in polyphenols may influence carbohydrate digestion and absorption and thus~     postprandial glycaemia. In addition berries have been reported to alter incretins as well as~     to have anti-oxidant and anti-inflammatory properties that may also affect postprandial~     glycaemia. This study investigated the acute affect of a standardised bilberry extract on~     glucose metabolism in T2D.~      Eight male volunteers with T2D controlling their diabetes by diet and lifestyle alone were~     given a single oral capsule of either 0.47g standardized bilberry extract (36% (w/w)~     anthocyanins) which equates to ∼50 g of fresh bilberries or placebo followed by a~     polysaccharide drink (equivalent to 75 g glucose) in a double blinded cross over intervention~     with a two week washout period.~      This study demonstrates that the ingestion of a concentrated bilberry extract reduces~     postprandial glycaemia and insulin in volunteers with T2D. The most likely mechanism for the~     lower glycaemic response involves reduced rates of carbohydrate digestion and/or absorption.~   "
177237|NCT01245257|"~     Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with~     alcoholic hepatitis. The liver might play an important role in this stress-catabolism by~     increasing the production of urea during the inflammatory process.~      The purpose of this study is to examine the regulation of urea synthesis in patients with~     alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and~     pentoxifylline on this regulation.~   "
177238|NCT01245244|"~     The aim of the current project is to use a model of painful stimulation of skin, muscles and~     internal organs, where it is possible to measure activity in the brain centers that process~     pain simultaneously. Magnetic resonance imaging and electroencephalography are combined to~     optimize the anatomical and physiological description of brain activation. During~     administration of morphine we will identify how different brain areas are affected. This~     knowledge will be used to:~      1. Understand the mechanisms of morphine to a greater extent than is possible today,~     including:~        1. to investigate the mechanisms of morphine versus placebo on pain signals in the spinal~          cord and brain. This is done by a combination of experimental pain models,~          neurophysiological and imaging techniques (EEG and fMRI). This can be achieved as both~          subjective and objective measures of the analgesic effect.~        2. to examine morphines effect on communication between the centers of the brain that are~          involved in painprocessing .~        3. modeling of morphine pharmacokinetics (the understanding of what the body does to the~          drug, such as. concentration in the blood and the brain), since this is central to~          understand the pharmacodynamics (the description of what the drug does to the body and~          thus the effect it has).~        4. to identify biomarkers that can predict whether healthy subjects respond to morphine by~          experiencing an analgesic effect.~   "
177239|NCT01245231|"~     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This research study is studying prognostic biomarkers in cell samples from young~     patients with acute myeloid leukemia.~   "
177240|NCT01245205|"~     This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206 and~     lapatinib ditosylate in treating patients with solid tumors or breast cancer that has spread~     to other places in the body. Akt inhibitor MK2206 and lapatinib ditosylate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
177241|NCT01245179|"~     The goal of this clinical research study is to find out about the safety and effects of a~     drug called panobinostat when given to adults with sickle cell disease. Panobinostat is a pan~     histone deacetylase (HDAC) inhibitor. HDAC inhibitors have been shown to significantly~     increase hemoglobin F induction, which is well documented to improve outcomes in sickle cell~     disease. HDAC inhibitors are also known to potently inhibit cell-specific inflammation, which~     is a primary contributor to the debilitating effects of sickle cell disease. Given the~     relevance of these mechanisms of action in SCD, panobinostat may prove to contribute~     significantly to the management of SCD patients, a population in critical need of further~     effective treatment options.~   "
177242|NCT01245166|"~     Type 2 diabetes mellitus is a chronic metabolic disorder which is caused by both insulin~     secretion deficiency and insulin action defect. In this type of subjects, fasting~     hyperglycemia is the result of the elevated rate of basal hepatic glucose production, and it~     is coexisting with hyperinsulinemia.After a meal, the impaired control of hepatic glucose~     production by insulin and decreased insulin-mediated glucose uptake by muscle contributed~     nearly equally to postprandial hyperglycemia(Scheen, 1997). Type 2 diabetic subjects~     experience significant morbidity and mortality from microvascular (retinopathy, nephropathy,~     and neuropathy) and macrovascular (cardiovascular disease, stroke, and peripheral vascular~     disease) complications. The appropriate treatment and good glycemic control of diabetes is~     therefore important and necessary (Vaag, 2006). Evidences suggest that combination therapy~     using oral antidiabetic agents with different mechanisms of action may be more effective in~     achieving and maintaining target blood glucose level (Turner et al., 2005).There are five~     classes of oral antihyperglycemic agents (sulfonylureas, biguanides, α- ucosidase inhibitors,~     thiazolidinediones and meglitinides) currently available to improve glycemic control in~     subjects with type 2 diabetes, each of which works through a different mechanism of action.~     Metformin, a biguanide which has insulin-sensitizing properties, can be used alone or in~     combination with other classes of agents. Metformin is the currently the first-choice~     treatment in subjects with diagnosed type 2 diabetic subjects and obesity, characterized by~     insulin-resistance. Metformin also provides reduction of body weight and ameliorates lipid~     abnormalities and is thought to be related to a reduction in hepatic gluconeogenesis (Hundal~     & Inzucchi, 2003).Acarbose, the α-glucosidase inhibitor, is approved for the treatment of~     type 2 diabetes, and first approved for prediabetes treatment (Chiasson et al., 1994; Breuer,~     2003; Chiasson et al., 2002). The drug was launched worldwide as a type 2 diabetes~     monotherapy and combination therapy in 1990 which has proven efficacious as first-line~     therapy (Coniff et al., 1995) and in combination with sulfonylureas or insulin (Kelley et~     al., 1998). Acarbose and metformin are both associated with beneficial effects on~     hyperglycemia, hyperinsulinemia, body weight, and, in some studies,triglyceride levels~     (Krentz et al., 1994). Because these factors are part of a cluster of risk factors for~     cardiovascular disease, combining the two drugs may be useful. In long-term clinical studies,~     acarbose has shown a favorable safety profile (Hasche et al., 1999).In combination with~     metformin, acarbose has been shown to improve long-term glycemic control (Rosenstock et al.,~     1998; Halimi et al., 2000). This study was conducted as a further vestigation into the~     efficacy and safety of concurrent use of acarbose and metformin in type 2 diabetes mellitus~     subjects.Lotus Pharmaceutical Co., Ltd. intends to initiate Phase III program to investigate~     assess the efficacy and safety of metformin in combination with acarbose for type 2 diabetes~     mellitus subjects considered inadequately blood glucose control. Since combination tablet of~     acarbose and metformin has not yet been approved by the Taiwan DOH, this study is conducted~     to evaluate the efficacy and safety of combination tablet of acarbose and metformin in the~     treatment of type 2 diabetes mellitus subjects in Taiwan. Acarbose is chosen as an~     active-comparator.~   "
177243|NCT01245153|"~     Urinary incontinence (UI) is a common and worldwide problem.Although pelvic floor muscle~     training(PFMT) is the standard recommendation for conservative treatment but some patients~     had difficulty doing PFMT. They could not locate the pelvic floor muscles, and so could not~     perform the PFMT properly or increase intensity of the exercise. The authors hypothesized~     that rectal balloon training(RBT) may improve patients' pelvic floor recognition as well as~     it is another option of progressive strengthening of pelvic floor muscle. This study's aim is~     to combine RBT with PFMT using the water-filled balloons of Foley catheters~   "
177244|NCT01245140|"~     The main purpose of this study is to demonstrate the improvement in the skin condition rate~     of patients receiving alitretinoin compared to patients receiving placebo.~   "
177245|NCT01245127|"~     Schnitzler syndrome:~      Schnitzler syndrome is a rare disabling autoinflammatory syndrome characterized by a chronic~     urticarial rash and monoclonal gammopathy, accompanied by intermittent fever, arthralgia or~     arthritis or bone pain. Diagnostic criteria have been established. The disease never remits~     spontaneously. Although there is no standard of care, there have been promising developments~     in therapeutic options, especially anti-interleukin-1 therapy. Anakinra, a synthetic analogue~     of the endogenous interleukin-1 receptor antagonist, has caused rapid clinical remission in~     24 patients with Schnitzler syndrome. However, to sustain remission, continuous daily~     administration (100 mg sc) is required. The level of monoclonal protein does not decrease.~     Side effects of anakinra include painful injection site reactions and neutropenia.~      Interleukin-1 and the autoinflammatory diseases:~      As a key proinflammatory cytokine mediating local and systemic responses to infection and~     tissue injury, interleukin-1 can induce a range of responses, including fever, pain~     sensitization, bone and cartilage destruction, and the acute-phase inflammatory response. The~     so-called autoinflammatory diseases are mediated entirely by interleukin-1; reducing~     interleukin-1 activity brings about a rapid and sustained remission. Autoinflammatory~     diseases include relatively uncommon disorders such as familial Mediterranean fever, adult~     and juvenile Still's disease, the hyper-IG D syndrome, Behçet's syndrome, the~     cryoporin-associated periodic syndrome (CAPS), deficiency of the interleukin-1 receptor~     antagonist (DIRA) and Schnitzler's syndrome. Some common conditions such as gout and type 2~     diabetes, are also likely to be autoinflammatory diseases.~      Canakinumab:~      Canakinumab (Ilaris, Novartis Pharma) is a fully human anti-interleukin-1-bèta monoclonal~     antibody. Treatment with subcutaneous canakinumab (150 mg) once every 8 weeks was associated~     with a rapid remission of symptoms in the great majority of children and adults with CAPS.~     Serum inflammatory markers quickly returned to normal. In general, the side effects seen in~     this small study (35 patients) were not serious, though suspected infections ware~     significantly more prevalent in patients receiving canakinumab than in those receiving~     placebo. The prolonged duration of action of canakinumab and low incidence of injection-site~     reactions may confer certain advantages over other interleukin-1 inhibitors (anakinra and~     rilonacept), since both are frequently associated with injection-site reactions, and both~     require more frequent administration (daily for anakinra and weekly for rilonacept).~      Canakinumab was approved for the treatment of CAPS by the US Food and Drug Administration in~     June 2009 and by the European Medicines Agency in October 2009.~      Canakinumab is currently being evaluated for its potential in the treatment of systemic-onset~     juvenile idiopathic arthritis, diabetes mellitus, and difficult-to-treat gouty arthritis.~   "
177246|NCT01245114|"~     Tuebingen High Altitude Ophthalmology Study to investigate the effects of high altitude on~     retinal structure and function as well as anterior chamber in regard to acute mountain~     sickness.~   "
177247|NCT01245101|"~     This study will examine whether intensification with raltegravir of a suppressive~     antiretroviral regimen in HIV infected patients with poor immune restoration has a beneficial~     effect on cryptic viral replication and the immune system. Specifically, the investigators~     will examine the effect that raltegravir intensification of ART has on episomal cDNA~     frequencies, immune activation, CD4+ cell counts and apoptosis, and markers of microbial~     translocation.~   "
177248|NCT01245088|"~     Pilot trial of open-label chondroitin sulfate 400 mg TID for adult patients with mild to~     moderate Crohn's disease. Primary endpoint with be evidence of bilogic effect assessed~     through serum and tissue cytokine analysis. Secondary endpoints are evidence of clinical~     effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.~   "
177273|NCT01244750|"~     The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI)~     in patients newly diagnosed with CML and their quality of life in a real-world setting.~   "
177249|NCT01245075|"~     The main objective of this study is to assess the efficacy of bilateral deep brain~     stimulation (DBS) of the Nucleus accumbens (NAc) as a novel treatment in severe opioid~     addiction. The included patients have been treated so far with a substitute in form of~     methadone.~      Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for~     heroin and thus enable the patients to decrease their Levomethadone-dosage substantially.~   "
177250|NCT01245062|"~     This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212~     to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV~     malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample.~     Subjects who have received up to one prior regimen of chemotherapy in the advanced or~     metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or~     MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1~     randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy~     arm). The primary endpoint for the statistical analysis will be a comparison of progression~     free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have~     progression on chemotherapy will be offered the option to receive GSK1120212.~   "
177251|NCT01245049|"~     The purpose of the study is to compare the immunogenicity and safety of a booster dose of~     BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a~     second dose of PriorixTM, in healthy 3 and 4-year-old children.~   "
177252|NCT01245036|"~     From the time sarcoidosis has been described, there has always been a belief that the disease~     is in some way related to tuberculosis. If indeed tuberculosis is a causal factor in~     sarcoidosis, then the hypothesis can be further reinforced, if anti-tubercular therapy (ATT)~     is useful in treatment of sarcoidosis. Very few trials have been conducted in the past but~     the results of these trials have been discouraging. These trials were generally small studies~     and limited by time bias and used older regimens based on isoniazid, amino-salicylic acid and~     streptomycin. In our experience nearly one third of patients who are finally diagnosed to~     have sarcoidosis, have received ATT for variable length of time, but its impact of final~     outcome of sarcoidosis has not been studied. The aim of this prospective randomized~     controlled trial (RCT) is to evaluate the efficacy and safety of Rifampicin and Isoniazid~     along with prednisolone compared to prednisolone alone in treatment of Sarcoidosis.~   "
177253|NCT01245023|"~     Laparoscopic adhesiolysis has been used in treatment of chronic abdominal pain. There has~     been only one previous controlled study, that stated laparoscopy alone had the same benefits~     than laparoscopic adhesiolysis. The aim of this study is to compare laparoscopic adhesiolysis~     with a placebo-procedure in chronic abdominal pain.~   "
177254|NCT01245010|"~     Research Question: Does replacing Sugar Sweetened (SS) beverages with water consumption~     promote a decrease in triglycerides blood levels over 9 months in overweight women? The~     primary outcome variable is the triglycerides blood level. In addition, the investigators~     will consider as secondary outcome variables the following parameters of metabolic syndrome:~     weight, fasting insulin and glucose, HOMA, HDL-cholesterol, systolic and diastolic blood~     pressure, and waist circumference. The investigators will also consider as an outcome~     variable glycosylated (or glycated) hemoglobin (HbA1c).~      Design: Two groups randomized controlled trial, with an intervention group (water and~     education provision) and control group (education provision only).~      The investigators propose to recruit young adult women aged >18-<45 y who are overweight or~     obese (BMI >25 and <39), and consume at least 250 calories per day from caloric beverages~     (e.g., includes soft drinks, juices, sports drinks, sweetened tea or coffee, and alcoholic~     beverages) The intervention group (water and education provision) will be compared with a~     control condition (education provision only). The intervention has been proposed to be~     carried out for 9 months period with objective measurements of body weight and fat, total~     cholesterol, LDL-C, HDL-C, fasting blood glucose, HbA1C, hydration status, blood pressure,~     and 24 hrs dietary recalls at baseline, 3,6 and 9 months~   "
177255|NCT01244997|"~     IRB4729 Study Hypothesis: Is there a significant difference in the hard and soft tissue~     response comparing immediate with delayed implant after tooth removal, with immediate~     provisionalization, in maxillary anterior sites.~      The purpose of this study is to determine and compare the crestal bone levels as the primary~     endpoint variable for implants placed and temporized in extraction sites, to implants placed~     into extraction sites after the extraction site has been grafted and healed for 4 months, all~     immediately restored with an anatomic provisional restoration.~   "
177256|NCT01244984|"~     The primary purpose of the study is to assess the safety and tolerability of 52-week teatment~     with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder~     once-daily in Japanese adult subjects with asthma.~   "
177257|NCT01244971|"~     The purpose of this study is to investigate the impact of exercise training, Acarbose, and~     the combination of exercise and Acarbose on glycemic control, body composition, insulin~     sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle~     biopsies will be obtain to study gene expression. Our hypothesis is that the combination~     therapy will be superior to monotherapy with exercise or Acarbose.~   "
177258|NCT01244958|"~     Combination of rituximab (RTX) with several different chemotherapeutic regimes has proven~     synergistic effects in patients with either lymphoma or autoimmune diseases. First data of~     uncontrolled trials with the combination of RTX and leflunomide (LEF) are available.~   "
177274|NCT01244737|"~     Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is~     important in the management of these tumors, but current imaging methods have limitations in~     providing the necessary information for optimal treatment of these patients. The goal of this~     study is to evaluate the potential utility of positron emission tomography (PET) with~     3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in~     children. Funding source - FDA Office of Orphan Product Development (OOPD)~   "
177275|NCT01244724|"~     The primary objective will be to pilot the use of escitalopram for the treatment of major~     depression in patients with epilepsy. The secondary objectives will be to determine effect~     sizes on scales measuring depressive symptoms, physical symptoms, psychosocial function and~     quality of life, and to evaluate safety in the population of patients with epilepsy.~      These results will be used to evaluate the possibility of a future double-blind, placebo~     controlled RCT of escitalopram for the treatment of major depression in patients with~     epilepsy.~   "
177259|NCT01244945|"~     The diffusion of gastrointestinal (GI) chronic diseases is significantly increased during the~     last century in western countries. In the USA and Northern Europe, constipation is twofold~     the prevalence found in the East and Southern Europe. In Italy, constipation affects up to~     15-17% of the whole adult population. Of them, more than half (about 10%) treats this~     disorder by assuming laxatives, while the remaining does not even assume drugs. A close~     relationship between intestinal environment and bacterial flora has been found. As a matter~     of fact changes in the intestinal physiology can modify the composition of bacterial flora as~     well as modifications in the intestinal microbiota can modify the physiology of the gut. The~     probiotic effects on the GI motility can be due to substances released by bacteria and/or~     products of their fermentation. Also, probiotic may indirectly act by the release of~     neuroendocrine factors and/or substances released by the immune system. Clinically, it has~     already been demonstrated that probiotics exert a positive effect on symptoms and intestinal~     habit in constipated IBS patients. In this framework, the idea to perform a long lasting~     intervention study in patients with functional constipation treated with probiotics sounds~     convincing. The present study is a randomized, double blind, placebo controlled, monocentric~     study, concerning the evaluation of efficacy of 3 months administration of Lactobacillus~     reuteri DSM 17938 in patients with functional constipation, as defined by the Rome criteria.~     Clinical, physiological, hematological and immunologic variables will be evaluated.~   "
177260|NCT01244932|"~     The purpose of this study is to determine the minimum effective volume of local anesthetic~     for interscalene brachial plexus block using ultrasound guidance and nerve stimulator~     guidance.~   "
177261|NCT01244906|"~     This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus~     following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced~     intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease~     the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune~     reconstitution, thereby improving the safety of the procedure. The past experience with~     post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism,~     which the investigators hope will translate into improved disease control through the well~     documented graft-versus-malignancy effects of donor T cells.~   "
177262|NCT01244893|"~     The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to~     process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process~     qualification (postPQ).~   "
177263|NCT01244880|"~     To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during~     causal learning as measured by fMRI compared to placebo in healthy human subjects, and to~     evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced~     by treatment with PF 02545920.~   "
177264|NCT01244867|"~     The primary objective is to assess the immunogenicity and safety and tolerability of two~     consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in~     part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®,~     compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).~   "
177265|NCT01244854|"~     Persons with serious mental illness are at increased risk of cardiovascular disease. The~     goals of this study are to test a treatment, Life Goals Collaborative Care to help promote~     health behavior change and to get feedback from patients and providers on what is needed to~     help better coordinate and physical and mental health care of these patients.~   "
177266|NCT01244841|"~     In patients with ST elevation myocardial infarction (STEMI)treated with primary percutaneous~     coronary intervention (PPCI) a subset with low risk for late complications can be identified.~     Early discharge (<72h) of these patients can compromise initiation of prophylaxis,~     information and other investigations. The researchers want to investigate prospectively~     whether early discharge compared to regular care have comparable patient centered outcomes at~     30 days follow-up.~   "
177267|NCT01244828|"~     This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in~     participants with schizophrenia. Participants in this study consist of schizophrenia with~     residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory,~     or elderly participants with schizophrenia. The treatment period is up to 52 weeks.~   "
177268|NCT01244815|"~     Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed~     episodes) will be evaluated in participants between 10 and 17 years old, who are either~     hospitalized or non-hospitalized. In this 3-weeks, double-blind, parallel design trial,~     eligible participants will be randomized to receive one out of three fixed dose levels of~     asenapine, or placebo. The study primary hypothesis is that at least one asenapine dose is~     superior to placebo as measured by the change from baseline to Day 21 in Young Mania Rating~     Scale (Y-MRS) total score. Trial medication and placebo are provided as identical-looking~     sublingual tablets; concurrent use of psychotropics is prohibited, except use of short-acting~     benzodiazepines and psychostimulants approved for the treatment of attention deficit~     hyperactivity disorder (ADHD). Main treatment effect is measured using Y-MRS and safety is~     evaluated using the recordings of adverse events, routine blood panels, physical examinations~     (including vital signs), and electrocardiograms. Participants who complete the double blind~     trial may be offered to continue (open-label) treatment with asenapine for an extended period~     of time. Follow-up information on safety parameters will be collected in all participants~     within 30 days following treatment discontinuation.~   "
177269|NCT01244802|"~     The objective of this study is to study immune memory generated against the yellow fever~     (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not~     receive vaccine shots; only immune responses to previous yellow fever vaccination will be~     studied. The study involves one or multiple blood draws.~   "
177270|NCT01244789|"~     Patients with stage 1 & 2 endometrial cancer are treated with surgery. Despite the fact that~     disease is confound to uterus, unfortunately some of these patients may relapse and die of~     their disease. Postoperative radiotherapy cannot improve survival. Chemotherapy has shown~     survival benefit in more advanced stage disease (stage 3 & 4).~      This study evaluates if one can improve survival in intermediate and high risk early-stage~     patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial~     where effect of postoperative chemotherapy is compared with postoperative observation alone~     (standard strategy).~      Substudy: Translational research~   "
177277|NCT01244698|"~     Antibiotics are used routinely in postoperative tissue expander based breast reconstruction~     (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are~     also used routinely in immediate breast reconstruction to prevent fluid accumulation and~     seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution~     since drains can be a source for infection by creating open channels to outside contaminants.~     Plastic surgery patients without closed suction drainage devices are usually not placed on~     prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is~     recommended for up to 24 hours only. These recommendations do not take into account the~     increased risk of indwelling closed suction drains. A recent survey of plastic surgeons,~     conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to~     extended outpatient administration following TE breast reconstruction.~      The study plans to prospectively enroll patients who will undergo immediate breast~     reconstruction with TE or AF based breast reconstruction. Using the above data and the~     current protocol, the investigators will investigate the optimal antibiotic discontinuation~     period for these patients. The investigators hypothesize that the use of 24-hour~     perioperative antibiotics in TE or AF based immediate breast reconstruction with closed~     suction drainage, does not result in an increased infection rate compared to prolonged~     postoperative antibiotic administration.~   "
177278|NCT01244685|"~     The purpose of this study is:~        -  To determine if the intraoperative fluid administration with the Deltex CardioQ~          esophageal Doppler will reduce the length of stay after elective bowel resection.~        -  The probe can be used to dynamically measure stroke volume and cardiac output. This~          information will assist us in determining the ideal amount of fluids to be administered.~        -  To determine if the fluid administration established by the esophageal probe will result~          in a shorter length of stay in elective bowel resection patients.~        -  The investigators plan to enroll 100 patients in this study.~   "
177279|NCT01244672|"~     The purpose of this study is to compare the frequency and severity of postoperative( after~     surgery) pain between two surgical techniques for treating severe hemorrhoids. The two~     techniques are called: transanal hemorrhoidal dearterialization (THD) and standard surgical~     excision (removal) of the hemorrhoids~   "
177280|NCT01244659|"~     Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS~     and Prograf® in post renal transplanted patients.~   "
177281|NCT01244646|"~     1. A prospective, non-interventional study, 125 patients with Diabetes Mellitus Type2 will~          be enrolled, who, while on metformin, have a sub-optimal glycemic control and who thus~          will receive additional treatment with a sulfonylurea (SU) derivative. At the start and~          at 3 and 6 months, during regular visits to the patient's General Practitioner, the~          patients will complete a series of questionnaires (Patient Reported Outcomes, PROs)~          directed at diabetes in general, at fear for hypoglycemia, at body weight, at treatment~          compliance and at general wellbeing. These PROs are the worry subscale of the~          Hypoglycaemic Fear Survey, Impact of Weight on Quality of Life, revised Diabetes Symptom~          Checklist, Problem Areas In Diabetes, EuroQol EQ-5D and Medication Adherence Report~          Scale. In total 75 questions. The frequency of hypoglycemic symptoms, incidence of~          hypoglycemic events and body weight changes will be assessed and the level of adherence~          to treatment will be investigated.~        2. Diabetic patients, M/F, aged >35, metformin treated, serum HbA1c ≥7.0% (within last~          month), informed consent provided, in whom a SU therapy is added. Patients with Type 1~          diabetes and with secondary diabetes will be excluded, and patients unable to understand~          and complete the questionnaires.~        3. Primary outcome variables are outcomes from HFS-w and IWQOL in relation to the frequency~          of hypoglycemic symptoms and body weight at 6 months and to weight change from 0 to 6~          months. Secondary outcome variables are the other PROs. The frequency of hypoglycemic~          symptoms, incidence of hypoglycemic events, changes in body weight and level of~          compliance will be addressed.~        4. The Intention To Treat analysis will be used, with Last Value Extended Forward from 3 to~          6 months in case of withdrawal after 3 months. Changes in outcome variables will be~          analysed by modelling time and potential dummy variables in a Generalized Estimating~          Equations analysis.~        5. Secondary, outcomes in HFS-w and IWQOL are compared with self-reported hypoglycemic~          symptoms, incidence of hypoglycemic events, body weight and change in body weight from 0~          to 6 months. Changes in all PRO's from 0 to 3 and 6 months, potential relationships~          between (changes in) the different questionnaires, such as with hypoglycemia symptoms,~          weight (changes) and treatment compliance will be evaluated. A search is done for~          baseline characteristics which predict outcomes and changes in PRO's, hypoglycemic~          symptoms, hypoglycemic events and weight changes.~   "
177282|NCT01244633|"~     Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. The~     currently available drug treatments are considered to be inadequate. This clinical trial is~     designed to test if ecopipam is effective for the treatment of Tourette's Syndrome in adults.~   "
177283|NCT01244620|"~     Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically~     relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5~     inhibitor).~      Tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and~     ambrisentan. Based on overall clinical drug-drug interaction profiles, and in vitro CYP~     enzymes and transporter data, a clinically relevant drug-drug interaction between sitaxsentan~     and tadalafil is not expected. Sildenafil is not expected to affect sitaxsentan~     pharmacokinetics (PK), as sitaxsentan is a substrate of CYP3A4 and CYP2C9, where sildenafil~     did not show clinically relevant effect on PK of substrates of CYP3A4 and CYP2C9.~   "
177284|NCT01244607|"~     The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity~     of nickel-induced allergic contact dermatitis.~   "
177285|NCT01244594|"~     Background:~      People with spinal cord injury (SCI) are at risk for many health conditions, some of which~     can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one~     way to obtain exercise after SCI. However, cycling with FES has only been done one way, which~     involves pedaling more quickly with less force to work against. Pedaling more slowly would~     allow the person to work against more force, which may lead to greater improvements in bone~     mineral density and muscle size. It may also lead to greater changes in bone make-up, body~     fat, and cholesterol levels. All of these improvements may lead to a decrease in bone~     fractures and cardiovascular disease, two major medical issues that exist in the SCI~     population. Study Aims: This study will compare the outcomes on bone, muscle and~     cardiovascular health between the commonly used method of pedaling more quickly to a new~     method of pedaling more slowly. Both groups will work against the maximal force possible. It~     is expected that the group pedaling more slowly will work against greater force and thus will~     have improved outcomes compared to other group pedaling faster. Methods: Twenty people with~     SCI, ages 18-65 years, will be randomly assigned to a treatment group and will participate in~     three 60-minute sessions per week for 6 months at an outpatient rehabilitation center. All~     subjects must have complete paralysis of both legs, but may have sensation preserved. Before~     and after 6 months of exercise, subjects will have an MRI scan to assess muscle size and~     bone, a dexascan to assess bone, a strength test using electrical stimulation to assess~     muscle force, an analysis of fat free body tissue, and lab work to measure cholesterol, bone~     factors that provide insight into bone change, and nutritional status. Relevance: If the~     protocol of pedaling more slowly results in greater improvements, this technique can be~     applied to clinical practice. Some people with SCI have FES cycles in their homes and many~     have been cycling for many years. This new technique may allow them to obtain more benefits~     than what they currently are receiving from FES cycling. In addition, it is important to~     maintain overall bone, muscle and cardiovascular health so that people with SCI are health~     and ready when spinal cord regeneration becomes clinically available.~   "
177286|NCT01244581|"~     The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating~     acute otitis media in children. The primary end point is time to disappearance of middle ear~     effusion which monitored by daily tympanometry performed by families and study physicians.~   "
177289|NCT01244542|"~     The aim of the investigators project is to explore the mechanisms of pain insensitivity in~     patients with schizophrenia, in order to prevent its invalidating consequences. The~     investigators will couple methods of experimental psychology with EEG and blood samplings, in~     order to distinguish the role of non-painful perception, attention, aversive effects, and~     pain expression, and the investigators will explore an original neurobiological hypothesis~     regarding the activation of opioid receptors.~   "
177290|NCT01244529|"~     The purpose of this study is to evaluate the comparability of lens fit and lens power of a~     new contact lens to the lens fit and lens power of two marketed lenses.~   "
177291|NCT01244516|"~     The purpose of this study is to compare the clinical performance of three silicone hydrogel~     contact lenses over a 2 week period.~   "
177292|NCT01244503|"~     The purpose of the study is to demonstrate that the ¹³C-Octanoate Breath Test (OBT) can be~     used as an aid, in conjunction with other clinical information and medical history, for~     evaluating disease severity and detecting NASH with a high probability.~   "
177293|NCT01244490|"~     For children and adolescents, how does SPD503 compare to placebo for the treatment of~     Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
177294|NCT01244477|"~     Traumatic experiences can have a profound negative effect on the lives and well-being of both~     the people who experience them and their loved ones. For those who experience post-traumatic~     stress disorder (PTSD), their interpersonal difficulties and social support further impact~     the success of treatment such that interpersonal difficulties are associated with mistrust~     and predict poor treatment outcome. In this proposal, the investigators use functional~     neuroimaging to understand the neurobiology of trust and mistrust in people with PTSD and to~     learn more about how successful treatment can improve trust and social functioning.~   "
177295|NCT01244464|"~     This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in~     China.~      Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™~     administered at 2, 3, and 4 months of age in population aged over 2 months old living in the~     study city China.~   "
177296|NCT01244451|"~     In the last ten years there have been significant developments in CLL treatment. The advent~     of fludarabine, rituximab and the association of chemo-immunotherapy have substantially~     increased overall response rate, CR rate, time to progression and may also have an impact on~     overall survival.~      Even though, CLL remains incurable and all patients eventually relapse and progressively~     become resistant to treatment. The development of an effective therapy that is not~     cross-resistant with the ones currently available as front-line treatment, is one of the~     clinical unmet needs within CLL.~      BendOfa is a non comparative phase II trial designed to determine the therapeutic benefit of~     bendamustine given together to ofatumumab in relapsed or resistant patients with CLL.~      Bendamustine is approved by FDA for CLL treatment, it is an hybrid drug with alkylating~     agents and purine analogue properties that may lack of cross resistance with fludarabine. It~     was utilized in CLL as a single agent and its association with rituximab is currently under~     clinical investigation.~      Ofatumumab is a new fully human anti-CD20 monoclonal antibody with high in vitro efficacy on~     CD20 low-expressing CLL cells. An early report showed that ofatumumab in single therapy is~     effective in highly pre-treated refractory CLL patients.~      Both drugs were generally well tolerated without unexpected untoward toxicity. On the basis~     of these data, bendamustine and ofatumumab could be a new effective and well tolerated~     combination for patients with relapsed and refractory CLL.~   "
177297|NCT01244438|"~     An open-label, non-randomized, single arm study to assess the safety, tolerability, and~     pharmacokinetics of FP-1039 given by weekly intravenous (IV) administrations in advanced~     endometrial cancer patients with FGFR2-specific mutations. FP-1039 will be dosed weekly~     starting at a dose of up to 16 mg/kg.~   "
177298|NCT01244425|"~     The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor~     Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding~     (i.e. oozing) in hepatic resection surgery when standard surgical techniques are~     insufficient.~   "
177299|NCT01244412|"~     This is the proof of concept study to evaluate the performance of an early stage prototype of~     a hand-held fundus camera.~   "
177300|NCT01244399|"~     Neural Tube Defects (NTDs) are multifactorial (genetic/environmental) diseases that arise~     from failure of embryonic neural tube closure. Several studies have demonstrated that~     periconceptional administration of folic acid can prevent approximately 70% of all NTDs~     cases. The finding of several NTDs cases in a single family, despite prophylactic therapy~     with folic acid, suggested that a proportion of human NTDs are folate-resistant. So far, no~     preventive therapy for folate-resistant NTDs is available. Studies performed on~     folate-resistant NTDs animal models have shown that inositol is effective in preventing NTDs~     occurrence. Preliminary results in patients with at least two previous pregnancies affected~     by NTDs, despite folic acid supplementation, indicate that periconceptional treatment with~     500 mg/day of inositol (three months before conception and two months after) is able to~     prevent NTDs recurrence in humans.~      Recently, caffeine intake (more than 10 mg/day) has been associated with an increased risk of~     NTDs, especially for subgroups of people that carry genetic variants for enzymes involved in~     caffeine metabolism.~      The teratogenic effects of caffeine are known since the 70s. Indeed, gynecologists suggest to~     pregnant women to avoid/reduce caffeine intake. It is still unknown, however, whether~     pre-conception caffeine intake interferes with prophylactic therapy for NTDs.~      In the proposed study, we aim to evaluate the effect of espresso consumption (corresponding~     to about 100 mg caffeine) on the pharmacokinetics of oral administered myo-inositol (MI), in~     order to highlight any possible negative effects of caffeine on MI adsorption and excretion~     before conception.~      The study will consist of two phases and will be carried on twelve healthy volunteers. During~     phase 1, volunteers will be kept for 15 days under inositol-poor diet; at the end of this~     period, 20 g of MI will be administrated in a single dose. Basal levels of serum and urinary~     concentration will be evaluated before MI administration (t0); subsequently, sampling will be~     performed 2, 4, 6 and 8 hours after MI administration. Phase 2 will consist of 15 additional~     days of inositol-poor diet: basal levels of MI will be again measured before MI~     administration. In phase 2, MI administration will be concomitant to caffeine exposure~     through singleespresso consumption. Samples will be collected at the same time points as in~     phase 1.~   "
177301|NCT01244386|"~     The purpose of this study is to validate the use of a low-dose computed tomography (CT)~     protocol and facilitate reduced radiation doses in patients with inflammatory bowel disease~     (IBD). This is to be achieved using new computer software (Iterative Reconstruction and~     Automatic Tube Modulation) which will enable low-dose CT imaging at doses equivalent to that~     of an abdominal radiograph.~   "
177302|NCT01244373|"~     To describe biocompatibility, postoperative results and complications after implantation of~     the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic~     acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge.~   "
177303|NCT01244360|"~     The purpose of this study is to examine the effects of resveratrol on health and human~     performance. The study will evaluate cognitive function and several indicators of physical~     health before and after taking a resveratrol supplement or a placebo for three weeks.~   "
177304|NCT01244347|"~     In 1991 the Medical Research Council Vitamin Study Group and in 1992 the Hungarian randomised~     clinical trial have shown conclusively that the risk of neural tube defects can be reduced~     substantially by taking folic acid during the peri-conceptional period. At present there is~     enough evidence to support the hypothesis that folic acid supplementation can reduce the risk~     of all congenital malformations or of a specific and selected group of them, namely: neural~     tube defects, oral clefts, cardiac defects, urinary tract anomalies except hypospadias, limb~     reduction defects, omphalocele, anal atresia and trisomy 21.~      The hypothesis that a higher intake of folic acid is related to an higher risk reduction of~     neural tube defects and of other congenital malformations is the main rationale for the~     present study.~      The present study is a randomized, double-blind, controlled trial evaluating whether~     supplementation with folic acid at high dose (4 mg/day) reduces the overall risk of major~     congenital malformations in the population more than the standard recommended dose (0.4~     mg/day). At the enrolment visit all the eligible women will be interviewed to assess~     sociodemographic, life style and health status. After randomization, women will be~     interviewed every 4 months to evaluate pregnancy status. Women who have a pregnancy diagnosis~     during the study period will be interviewed by telephone at the expected 16, 24 and 40 weeks~     of gestation to evaluate the pregnancy outcome. The health status of live births will be~     evaluated at the child's age of 1 month, 3 months and 1 year.~      The primary aim of this project is conducting a study to assess the effect of folic acid~     periconceptional supplementation of 4 mg/day compared to the 0.4 mg/day standard dose on~     reducing the occurrence of all congenital malformations. Secondary aims of this study include~     comparing severity of CMs in offspring of trial mothers, rates of selected congenital~     malformations, rates of twinning, miscarriages, recurrent abortions, small-for-gestational~     age, preeclampsia and abruptio placentae. The sample size is not easy to be computed because~     lacking robust estimate of the size effect of the treatment. Three hypotheses of a size~     effect of 45%, 26% and 13% were considered. A sample size of outcomes (and women)~     respectively of 2,006 (5,015), 8,510 (21,275) and 30,126 (75,315) is needed. Since the sample~     size needed to evaluate different scenarios is large, the present study is also the pilot~     study to promote an international prospective meta-analysis.~   "
177305|NCT01244334|"~     The purpose of this clinical research study is to investigate the efficacy of predosing~     patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic~     emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal~     thickness.~   "
177306|NCT01244321|"~     The objective of this controlled, non-randomized, single-center pilot study (CoSeal arm~     prospective)study is to evaluate the efficacy of the synthetic surgical hydrogel CoSeal® in~     the prevention of cardiac adhesion formation in patients submitted to VAD procedures.~   "
177307|NCT01244308|"~     It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for~     avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.~   "
177308|NCT01244295|"~     A comparison study of 16 week treatment with either specialized psychotherapy for complicated~     grief (CGT) or with standard interpersonal psychotherapy (IPT) in older adults with~     complicated grief.~   "
177309|NCT01244282|"~     This study will identify a dose of ferumoxytol that can reliably detect changes in blood~     flow/volume in response to non-drug stimuli. The study will determine whether signal~     detection for functional magnetic resonance imaging (fMRI) using ferumoxytol is better than~     that for blood oxygen level-dependent (BOLD) fMRI in response to sensory stimulation. The~     following procedures will be conducted in each of two study periods: arterial spin labeling~     (ASL) imaging study with increasing exposure to carbon dioxide (CO2); BOLD fMRI study with~     sensory stimulation; MRI studies with sensory stimulation in the presence of increasing doses~     of ferumoxytol; MRI study with increasing exposure to CO2 in the presence of ferumoxytol.~     There will be a 3-week interval between the two study periods. The study will enroll 8~     subjects, but an additional 4 subjects are permitted to enroll to preserve study power.~   "
177310|NCT01244269|"~     This project aims to determine if methylphenidate can improve deficits in attention and~     symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with~     Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on~     postural control in these patients, a debilitating motor symptom that places patients at an~     increased risk of falling. This study will build on existing data to support a new indication~     for the use of methylphenidate in Parkinson's Disease. Using standard and objective~     evaluations, this study will quantify the effect of methylphenidate at two doses on attention~     levels, orthostatic hypotension, and measures of postural control. Phase I of the study will~     compare methylphenidate 10mg three times daily to placebo and Phase II of the study, for~     those tolerating the lower dose in Phase I, will compare methylphenidate 20mg three times~     daily to placebo. By incorporating two different doses, the study also seeks to determine if~     any improvements are dose-related. Secondary endpoints will include safety assessments~     (adverse event monitoring and vital signs) performed every 30 minutes following supervised~     drug administration. Visual analog scales will be presented to each participant before~     treatment and following the final dose of each treatment to assess changes in fatigue. A~     secondary task will be added to postural tests to assess the influence of cognitive~     processes. It is hypothesized that methylphenidate will demonstrate a significant beneficial~     effect on all outcomes. It is projected that objective improvements will be observed~     following treatment with methylphenidate at both doses (10 and 20mg three time daily) when~     compared to placebo. It is further hypothesized that the effects will be dose-related and~     therefore more profound with higher doses.~   "
177311|NCT01244256|"~     The objective of this trial is to evaluate the comparative efficacy of the combination of~     Clotrimazole + Gentamicin + Beclomethasone in study subjects with a condition of contaminated~     dermatosis showing bilateral symmetrical lesions.~   "
177312|NCT01244243|"~     The purpose of this study is to develop and assess the effectiveness of robot-assisted~     movement therapy in enhancing hand motor function in subjects with chronic hemiparetic~     stroke, and to identify predictors of treatment response.~   "
177313|NCT01244230|"~     Primary Objective:~      To evaluate safety (4 weeks)~      Secondary Objectives:~        -  To evaluate the long-term safety (12 weeks)~        -  To evaluate the efficacy~        -  To characterize the pharmacokinetic profile~   "
177314|NCT01244217|"~     Primary Objective:~      - To evaluate safety (4 weeks)~      Secondary Objectives:~        -  To evaluate the long-term safety (12 weeks)~        -  To evaluate the efficacy~        -  To characterize the pharmacokinetic profile~   "
177315|NCT01244204|"~     The investigators proposed a pilot study preparatory to developing a randomized trial of~     vitamin D for the prevention of TB infection. The specific aims are presented below:~        1. To recruit subjects, obtain consent, distribute vitamin D supplements to the children in~          the schools, obtain blood samples and transport them to the United States.~        2. To test the hypothesis that daily vitamin D supplementation will increase plasma levels~          of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages~          tested in vitro.~   "
181802|NCT01185197|"~     Study objective: To investigate the potential therapeutic efficacy of enteric-coated~     mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for~     minimal change nephrotic syndrome (MCNS).~   "
177316|NCT01244191|"~     This study is to determine if the combination regimen of tivantinib with erlotinib will~     improve overall survival relative to erlotinib alone in subjects with locally advanced or~     metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic~     anti-cancer therapies.~   "
177317|NCT01244178|"~     Insulin regulates blood sugar and acts to suppress inflammation. Hyperinsulinemic Therapy is~     a protocol for Insulin administration that involves the administration of a calculated higher~     dose of insulin into the blood stream. This therapy is called dextrose/insulin clamp. It has~     been shown to be safe and successful in maintaining normal glucose levels.~      The objective of the study is to assess if the clamp can achieve a steady and normal blood~     glucose level in patients admitted to the intensive care unit with sepsis. Furthermore, if~     the higher insulin dose would lead to a drop in the inflammatory response seen in septic~     patients.~   "
177318|NCT01244165|"~     To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the~     treatment of pelvic organ prolapse.~   "
177319|NCT01244152|"~     The primary aim of the study is to design a group-based, culturally appropriate~     self-management skills training intervention for disadvantaged African-Americans with both~     diabetes and hypertension and to compile an intervention Manual of Operations (MOO). The~     investigators are developing an intervention to assist individuals in reducing weight and~     hemoglobin A1c.~   "
177320|NCT01244139|"~     The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic~     profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with~     MS.~      Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups~     (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of~     BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will~     review all safety data from previous groups enrolled, as well as data from another study~     where BIIB033 is being administered to healthy volunteers (215HV101).~   "
177321|NCT01244126|"~     The purpose of this study is to compare the difference in effect of three clinically common~     methods of providing pain medication during surgery for ventilating tubes placed for~     recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in a~     muscle, and morphine injected in a vein.~   "
177322|NCT01244113|"~     The children with CP has been shown different drug responses from the normal population of~     children and it may related with a various oral medications such as baclofen, tizanidine,~     diazepam, dantrolene, or anticonvulsant drugs.~      The aim of this study is to establish the optimal induction dose of propofol for deep~     sedation to start MRI for < 30 min in children with CP.~   "
177323|NCT01244100|"~     This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.~   "
177324|NCT01244087|"~     The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie~     (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry~     of their thoughts and beliefs connected to stressful circumstances or symptoms. This~     meditative process, named The Work, enables the participants to identify and question the~     stressful thoughts that cause their suffering. The core of IBSR is simply four questions and~     a turnaround, which is a way of experiencing the opposite of what the participant believes.~     This process is simple, powerful and can be easily implemented in daily life.~      Therefore, on the basis of previous data and beneficial observations the investigators~     postulate that the clinical utility of IBSR mediation program may improve psychological and~     physical symptoms and quality of life among BC patients during the survivorship period. Thus,~     we will conduct a pilot/feasibility randomized controlled clinical trial designed to~        -  Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and~          program satisfaction.~        -  Determine whether IBSR intervention compared with usual care is efficacious in improving~          quality of life, psychological and physical status in BC survivors.~   "
177325|NCT01244074|"~     The Visual Pathfinder (LACE inc.) offers a non- invasive, patient- centered visual~     rehabilitation system based on an acoustic biofeedback. The investigators wanted to evaluate~     its usefulness in the improvement of visual function in visually impaired patients with high~     myopia.~   "
177326|NCT01244061|"~     The main purpose of this study is to compare the effectiveness and safety of the re-treatment~     of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a~     12 week course of treatment. The study will also assess whether smokers remain abstinent at~     Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of~     treatment).~   "
177327|NCT01244048|"~     The effective dosage of a n3-LC-PUFA intervention (with n3 LC-PUFA-enriched yoghurt) on the~     modulation of cardiovascular risk factors and inflammatory biomarkers were determined.~   "
177328|NCT01244035|"~     This is a two part study comprising sequential double-dummy, placebo controlled 3-period~     randomized crossover studies. The study will evaluate the safety, tolerability,~     pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266.~   "
177329|NCT01244022|"~     Based on our previous research, this study aims to determine reliable surgical stress~     response markers in patients undergoing radical resection of colorectal cancer.~   "
177330|NCT01244009|"~     This study will investigate the efficacy and safety of MK-4827 in participants with relapsed~     mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the~     Ataxia-Telangiectasia Mutated (ATM) gene.~   "
177331|NCT01243996|"~     The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher~     than those actually recommended might increase the closure rate in preterm infants with~     gestational age <29 weeks without increasing the occurrence of associated adverse effects. To~     assess this hypothesis the investigators planned a multicenter randomized controlled study to~     compare the effectiveness of the current ibuprofen regimen to that of a high-dose regimen in~     closing PDA.~   "
177332|NCT01243983|"~     The primary objective of this study is to assess the safety and efficacy of voclosporin as~     therapy in subjects with active noninfectious uveitis involving the intermediate and/or~     posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or~     pan-uveitis).~   "
177384|NCT01243307|"~     The primary objective of this study is to compare the effect of CT327 to placebo against~     experimental induced superficial, deep and hyperalgesic pain.~      The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain~     models.~   "
177333|NCT01243970|"~     ECG changes during caesarean section are common. Incidence of ST depression on the ECG is up~     to 81% in some studies. Although this may indicate inadequate oxygen supply to the heart~     muscle (myocardial ischaemia) many other theories have been suggested including air entering~     the circulation from the placental bed, high heart rate, hormone or nervous system influences~     and spasm of the coronary blood supply. Perioperative ST depression often reflects an~     imbalance between heart muscle oxygen supply and demand. At the time of delivery, high heart~     rate is common and there is a further increase in the amount of blood the heart has to pump~     every minute due to blood coming back to the circulation from the placental bed. This~     increases oxygen demand and most ST changes are seen at the time of delivery or within 30~     minutes. The clinical significance of these changes is much debated, and apart from a few~     case reports do not appear to be associated with poor heart muscle function or ischaemia~     (lack of oxygen supply). Management of the mother's blood pressure during caesarean section~     has changed greatly in recent years. Intermittent boluses of ephedrine, given when blood~     pressure is low, have been replaced with prevention of low blood pressure and phenylephrine~     has become the drug of choice. Ephedrine increases heart rate and contractility of the heart~     muscle and is likely to increase oxygen demand. Phenylephrine reduces heart rate while~     maintaining blood pressure which may result in a more favorable oxygen supply demand ratio.~      The investigators aim to compare the incidence of ECG changes if the mother's blood pressure~     is maintained with phenylephrine as compared to ephedrine. To see if these ECG changes are~     associated with myocardial ischaemia, the investigators will perform troponin T analysis~     after delivery. Troponin T is a molecule released by ischaemic heart muscle.~   "
177334|NCT01243957|"~     The purpose of this study is to measure if there is any difference in how the body breaks~     down or inactivates either fluoxetine or LY2216684 when both of these medicines are given~     together. This study will look at how fluoxetine might affect LY2216684 and how giving~     LY2216684 might affect fluoxetine in the body.~      The duration of study participation in this study is approximately 36 days not including the~     screening appointment. This study requires 1 research unit confinement of 29 days/28 nights~     followed by 1 outpatient appointment. A screening appointment is required within 30 days~     prior to the start of the study.~   "
177335|NCT01243944|"~     This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of~     ruxolitinib (INC424) to Best Available Therapy (BAT) in subjects with polycythemia vera (PV)~     who are resistant to or intolerant of hydroxyurea (HU).~   "
177336|NCT01243931|"~     Optical Coherence Tomography (OCT) machines are non-contact instruments that can measure the~     depth of scars and other causes of cloudiness in the front of the cornea. The purpose of this~     study is to determine whether OCT-guided settings for the lasers used for removal of corneal~     scars and other partial-thickness corneal defects result in improved vision in patients~     receiving these procedures.~   "
177337|NCT01243918|"~     The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery~     system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non~     invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen~     therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the~     successive use of systems Optiflow®/Non invasive ventilation.~   "
177338|NCT01243905|"~     The purpose of this study is to examine the effectiveness of group psychoeducation for the~     psychological distress of mothers with the children of high-functioning pervasive~     developmental disorder and for their behavior based on disorder traits.~   "
177339|NCT01243892|"~     This is a Phase IV, open label, case-controlled, observational study to evaluate the~     age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient~     (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin~     (recombinant human growth hormone [rhGH]; Nutropin) using NuSpin device compared to~     historical controls from the national cooperative growth study (NCGS).~   "
177340|NCT01243879|"~     Calorie restriction extends life span and prevents aging-related diseases in several species.~     Odorants from live yeast restrain the beneficial effects of calorie restriction in Drosophila~     Melanogaster. The investigators hypothesize that visual and odorous food stimuli impact the~     neuroendocrine and metabolic response to starvation in healthy humans.~      In this randomized cross-over intervention study 12 healthy, young men will fast twice for~     60-hours in the presence or absence of food-related visual and odorous stimuli. At baseline~     and on the last morning of each intervention an oral glucose tolerance test (OGTT) will be~     performed. During the OGTT blood is sampled and hypothalamic neuronal activity is measured by~     functional MRI.~   "
177341|NCT01243866|"~     Severe dental decay affects children physically, emotionally, socially and thereby impacts on~     their quality of life. Evidence from developed countries showed that children with severe~     dental decay weighed less than their peers and following dental treatment children's growth~     and quality of life improved. This suggests that treatment of severe dental decay may enhance~     growth and wellbeing. A study was carried out in Saudi to test that hypothesis.~   "
177342|NCT01243853|"~     The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in~     alleviating the symptoms of irritable bowel syndrome (IBS).~   "
177343|NCT01243840|"~     Purpose of the study~        1. The predictive value of central aortic pressure and aortic pulse wave velocity (PWV) in~          a Japanese population is not known. The purpose of this study is to quantify the~          predictive value of these indices in the determination of cardiovascular risk.~        2. Recently, a non-invasive method to separate the aortic pressure waveform into the~          separate ejection pressure wave and reflected pressure wave has become available. With~          this decomposition method, it is possible to estimate aortic PWV (named AVI). The second~          objective of this study is to determine if AVI can be a substitute for carotid-femoral~          PWV (cf-PWV), the current gold standard for aortic PWV measurement.~        3. To study vascular aging of the Japanese population by evaluating central blood pressure~          and aortic PWV by age, and compare these values to similar studies done in Caucasian and~          Chinese patient populations.~        4. To study the relationship between the magnitude of the aortic reflected pressure wave~          and the degree of left ventricular (LV) hypertrophy and LV diastolic function.~   "
177344|NCT01243827|"~     The purpose of this study is to compare of carvedilol, a vasodilating beta-blocker and~     bisoprolol, a beta1- selective beta-blocker for reducing the central pulse pressure and~     thereby left ventricular (LV) mass in never-treated hypertensive patients.~   "
177345|NCT01243814|"~     To compare the therapeutic effect of single intra-articular injection of hyaluronate with a~     single intra-articular injection of normal saline (placebo) for osteoarthritis of the ankle.~   "
177385|NCT01243294|"~     The objective of this investigation is to evaluate leakage, handling and comfort of a new~     ostomy appliance compared to SenSura.~   "
177523|NCT01241448|"~     LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is~     designed to compare LY2409021 given alone or given in combination with metformin against~     placebo the change in hemoglobin A1c after a 24-week treatment period.~   "
177346|NCT01243801|"~     Postthoracotomy acute pain is followed by persistent postsurgical pain in 20-30% of the~     patients, defined as pain that lasts more than 3-6 months after surgery. Acute pain and~     hyperalgesia around the surgical wound are some of the risk factors associated to the~     development of chronic pain. Ketamine, as a NMDA antagonist mainly at spinal level, might~     reduce periincisional hyperalgesia and persistent postsurgical pain after thoracotomy.~     Therefore, the investigators hypothesized that continuous ketamine infusion at subanesthetic~     dose would potentiate epidural ropivacaine and fentanyl-induced analgesia after thoracotomy,~     reduce periincisional hyperalgesia and long-term postoperative pain. To test these~     hypothesis, the investigators administered a low dose of intravenous ketamine or epidural~     ketamine or placebo to patients who received an epidural infusion of ropivacaine and fentanyl~     for postthoracotomy pain.~   "
177347|NCT01243788|"~     To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs~     Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic~     Obstructive Pulmonary Disease (COPD).~   "
177348|NCT01243775|"~     Lung cancer is the leading cause of cancer death in Korea as well as in other countries.~     About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with~     NSCLC require cytotoxic chemotherapy in the course of their illness. Combination chemotherapy~     using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine) with~     platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin, another~     platinum being used for colorectal, gastric and pancreatic cancer has lower adverse effects~     such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy and~     safety of docetaxel and oxaliplatin for patients with NSCLC.~   "
177349|NCT01243762|"~     This is an open-label, two-part study to evaluate the safety and tolerability of combination~     treatment with dalotuzumab + MK-2206, dalotuzumab + MK-0752, or dalotuzumab + ridaforolimus~     (MK-8669). Part 1 of the study will determine the dose-limiting toxicities (DLTs) observed~     after administration of each of the combinations at various doses and define the maximum~     tolerated dose (MTD) of each combination. Part 2 of the study will assess preliminary~     anti-tumor activity of these combinations (at MTD) in two groups of participants with~     selected tumor biomarkers: one group with metastatic or recurrent platinum-resistant ovarian~     cancer, fallopian tube cancer, or primary peritoneal cancer and one group with metastatic or~     recurrent colorectal cancer. The dalotuzumab + ridaforolimus and dalotuzumab + MK-2206 arms~     will be enriched with female platinum-resistant ovarian cancer, fallopian tube cancer, or~     primary peritoneal cancer participants. The dalotuzumab + MK-0752 arm will be enriched with~     metastatic or recurrent wild-type kirsten rat sarcoma (KRAS) colorectal cancer participants.~      The primary hypothesis is that the DLTs observed in adult patients with locally advanced or~     metastatic solid tumors after administration of each of the MK-MK doublets will be~     dose-dependent to allow for definition of a MTD within each MK-MK doublet.~   "
177350|NCT01243749|"~     To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting~     Coronary Stent System in a real-world patient population requiring stent implantation.~   "
177351|NCT01243736|"~     The investigators are conducting a study to see if taking a bowel preparation before having a~     capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the~     night before a capsule endoscopy in making it easier to see the small bowel in order to find~     the source of gastrointestinal bleeding.~   "
177352|NCT01243723|"~     The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment~     of patients with dyschesia.~   "
177353|NCT01243710|"~     The purpose of this study is to determine whether taurolidine with heparin locking solution~     prevents recurrence of central venous catheter related blood stream infections in~     haemodialysis patients.~   "
177354|NCT01243697|"~     The congenital central hypoventilation syndrome (CCHS), also known as the Ondine syndrome, is~     a very rare genetic disorder. In contrast with healthy people, patients do not increase~     breathing in response to an excess of carbon dioxide (CO2). As a consequence, they do not~     breath sufficiently, or even stop breathing, during sleep. Their survival depends only on~     mechanical respiratory assistance, all life long.~      We have recently published two cases of recovery of a response to CO2 in patients taking~     desogestrel as a contraceptive pill. The goal of the study is therefore to assess the~     hypothesis that desogestrel will restore a respiratory response to CO2 in CCHS patients and~     allow them to breath sufficiently during sleep without mechanical assistance.~   "
177355|NCT01243684|"~     This study aims at evaluating spinal cord structure using diffusion tensor imaging in~     patients with cervical spondylosis.~   "
177356|NCT01243671|"~     To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for~     Japanese subjects with intestinal Behçet's disease who are refractory to conventional~     therapies.~   "
177357|NCT01243658|"~     RCT. Two substudies (clinical and experimental). Main objective of the trial is to examine if~     oxytocin, compared to placebo shows any additional effect on the therapy achievements~     (outcome) of patients with borderline personality disorder, who receive an in-patient~     standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).~      Secondary objectives :~      Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in~     patients with borderline personality disorder. Comparison of the effects of Oxytocin on~     patients with BPD and major depression.~   "
177358|NCT01243645|"~     Background:~      Biofeedback techniques have demonstrated their uselfulness in the treatment of maculopathies.~     We wanted to evaluate the efficacy of visual rehabilitation by means of two different types~     of biofeedback techniques in patients with age related macular degeneration (AMD).~      Methods:~      30 patients bilaterally affected by AMD were enrolled with a mean age of 76,38±8,77 yrs.~     Patients were randomly divided in two groups: Group A was treated with an acoustic~     biofeedback, Group B with luminous biofeedback of a black and white checkerboard flickering~     during the examination. All patients underwent a complete ophthalmological examination.~     Rehabilitation consisted in 12 training sessions of 10 minutes for each eye performed once a~     week for both groups. Statistical analysis was performed using t- test. P values less than~     0.05 were considered statistically significant.~      Results:~      Group A: visual acuity at the end of rehabilitation had improved, but this result was not~     statistically significant (p=0.054), reading speed showed a significant statistical~     improvement (p=0.031), as well as the fixation stability (p=0.0023) and single point mean~     retinal sensitivity value (p=0.044).~      Group B: visual acuity improvement at the end of rehabilitation was statistically significant~     (p=0.048), reading speed showed a statistically significant improvement (p=0.024), as well as~     fixation stability (p=0.0012) and mean single point retinal sensitivity value (p=0.027).~     Final results for both groups were compared and patients in group B showed results which were~     statistically more significant.~      Conclusion:~      A contrast rich flickering biofeedback stimulus showed a statistically significant~     improvement in training the patients to modify their preferred retinal locus (PRL) in~     comparison to acoustic biofeedback. It is possible that increased involvement of the various~     retinal cell populations with visual stimuli create more efficient ganglion cell response~     that better utilize the residual retinal function.~   "
177359|NCT01243632|"~     Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in~     mesothelioma patients. However, median survival of this patient group was only about 12~     months. With intent to find more effective treatment the investigators performed phase II~     study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in~     combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer~     Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore~     such regiment in patients with malignant pleural mesothelioma (MPM) as well.~   "
177360|NCT01243619|"~     The purpose of this pilot study is to develop a more advanced software program that will~     collect, compare and analyze tumor images for evaluation. Another purpose of this study is to~     learn if a new radio-tracer for tumor imaging called 3'-deoxy-3'(18) F-fluorothymidine (FLT)~     can improve the evaluation of tumors during a PET/CT scan. This new type of image tracking is~     meant to improve the visualization of tumor active and size.~   "
177361|NCT01243606|"~     Anxiety disorders are common, chronic, costly, debilitating to quality of life, and are more~     prevalent than any other class of disorders in every country in the world where surveys have~     been taken. Deepening understanding of the nature of anxiety and related emotional disorders~     during the last decade has revealed that commonalities in etiology and latent structure among~     these disorders supersedes differences. At the same time, examination of extant single~     diagnosis psychological treatment protocols (SDPs) for these disorders underscores~     mechanistic similarities. These findings suggested the possibility of distilling a set of~     psychological procedures that would comprise an innovative Unified Protocol for~     Transdiagnostic Treatment of Emotional Disorders (UP), and this protocol has now been~     developed. If efficacious, the UP may represent a more efficient and possibly more effective~     strategy which would render treatment implications of comorbidity, not otherwise specified~     (NOS) and subdefinitional threshold anxiety disorder conditions moot.~      The investigators now propose an evaluation of the efficacy of the UP in a group of patients~     with heterogeneous anxiety disorders by way of rigorous comparisons to existing evidence~     based SDPs benchmarked against a wait list control condition, using both statistical~     equivalence and superiority analyses. Additional aims include determining the durability of~     the UP relative to comparison conditions after treatment discontinuation, and ascertaining~     the differential impact of treatments on disorder specific symptoms vs. higher-order~     temperamental variables. Further analyses will indicate if changes in these higher order~     temperamental variables mediate long-term outcome as preliminary data suggests, and if this~     mechanism of action differs among treatments.~   "
177362|NCT01243593|"~     The purpose of this study is to evaluate the effectiveness of transversus abdominis plane~     (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty~     surgery in children.~   "
177363|NCT01243580|"~     Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be~     evaluated.~   "
177364|NCT01243567|"~     This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination~     (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never~     been previously treated and are at high risk for progression.~   "
177365|NCT01243554|"~     Observational studies demonstrate that overweight in pregnancy is a risk factor for adverse~     pregnancy outcomes as fetal macrosomia, prolonged labor, low Apgar score, shoulder dystocia,~     nerve plexus injuries, increased proportion of instrumental deliveries and perineal ruptures.~     There is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly obese women)~     and a recent study has shown that fetuses of obese mothers develop insulin resistance in~     uterus.~      Main aims of this study are to assess if regular exercise in pregnancy among obese women can~     prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn;~     impaired vascular function in mother; insulin resistance/sensitivity; body composition in~     mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor~   "
177366|NCT01243541|"~     RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients~     receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing~     peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving~     paclitaxel.~   "
177367|NCT01243528|"~     The purpose of this trial is to determine whether nutritional status has an impact on~     nosocomial infections. Study population are patients undergoing early neurological~     rehabilitation.~   "
177368|NCT01243515|"~     The primary objective of this study is to determine whether a correlation exists between the~     Mespere Non-Invasive Central Venous Pressure (NICVP) device for measuring central venous~     pressure (CVP), and assessment of CVP via physical examination.~   "
177369|NCT01243502|"~     K-252a is a potent inhibitor of nerve growth factor (NGF) and therefore has the ability to~     inhibit keratinocyte proliferation. K-252a is strongly lipophilic and therefore passes freely~     into the cell membranes of keratinocytes and accumulates at a systemic level. In order to~     reduce the dermal absorption and reduce the possible long-term systemic toxicity this study~     will assess a PEGylated derivative of K-252a named CT327. This approach should improve the~     safety profile of the K-252a molecule while maintaining its activity. The primary objective~     is to assess the safety and tolerability of single and repeat doses of CT327 when applied~     topically to the skin of healthy male volunteers.~      The secondary objective is to evaluate the eventual systemic absorption (pharmacokinetics;~     PK) of CT327 following single and repeat doses in healthy male subjects.~   "
177370|NCT01243489|"~     This study on patient's compliance in clinical workaday life aims to assess and to improve~     CML treatment in Germany by means of adherence supporting measures and to increase adherence~     awareness by physicians and patients.~   "
177386|NCT01243281|"~     The outcome of treatment of chronic hepatitis B is determined by viral and host interaction,~     thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug~     (entecavir) should improve the response rate. In addition, the simultaneous assessment of~     viral and host genetic factors associated with SVR may help to identify predictors of~     treatment outcomes, which will in turn significant reduce the cost/effect of therapy~   "
177387|NCT01243268|"~     This is a prospective, observational, open-label, multi-center study, which will provide~     detailed information about the safety and efficacy of Twynsta tablets in Korean hypertensive~     patients requiring combination therapy. This will present a convenient treatment option for~     hypertension in Korean patients.~   "
177371|NCT01243476|"~     Trial Design:~      This clinical trial is a phase III multicenter, randomized, double blind and controlled with~     placebo trial and with two arms designed to assess the efficiency and toxicity of the scheme~     Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic~     syndrome associated to 5q deletion with anemia (Hb≤12g/dL) but without the need of~     transfusion. Patients are randomized in the study in a 2:1 ratio. They will receive treatment~     for 104 weeks until progression of the disease, which implies that the patient suffering from~     anemia due to myelodysplastic syndrome requires transfusion of at least 2 UCH/56 days (2~     months) with a minimum follow up of 112 days (4 months), or unacceptable toxicity.~      Disease:~      Low risk myelodysplastic syndrome associated to the loss of 5q without transfusion~     requirements.~      Total number of patients:~      In total 60 patients will be included, 40 assigned to the treatment branch and 20 to the~     placebo branch.~      Calendar:~      First patient first visit: February 2010, and Last patient last visit expected in February~     2016. (Recruitment was initially expected to take place over a period of 24 months and was~     expected to be finished in February 2012, but due to low rate of recruitment it was extended~     until the population sample is included in the trial).~   "
177372|NCT01243463|"~     More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each~     disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric~     surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two~     conditions separately, and these treatment modalities both present a unique set of challenges~     in terms of patient-adherence. Furthermore, the combined effects of these therapies on body~     weight and OSA severity are unclear, and require longitudinal investigation. The purpose of~     the research proposed herein is twofold: A) To prospectively demonstrate the specific~     physiologic/psychological improvements in OSA risk factors and disease severity that occur in~     a subset of bariatric surgery patients with OSA, who are being effectively treated with PAP~     and furthermore; B) To elucidate differences in postoperative outcomes (weight-loss,~     dyslipidemia, OSA severity, comorbidity resolution) between patients who are compliant or~     non-compliant with prescribed PAP therapy. The investigators anticipate that results will be~     used to develop and streamline approaches to improve pulmonary/sleep-related outcomes in~     bariatric surgery patients. Furthermore, this line of research has many implications for~     strategies to strengthen the coordination of care between bariatric surgery, pulmonology, and~     other clinical sub-specialties that are integral to the postoperative health of these~     patients.~   "
177373|NCT01243450|"~     The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear~     Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.~   "
177374|NCT01243437|"~     Plague is a severe, life-threatening disease. Plague occurs in focal locations worldwide, but~     over 95% of human cases reported to WHO are by countries in Africa. The most common clinical~     manifestations of human infection are bubonic, septicemic, and pneumonic plague. Untreated~     pneumonic or septicemic plague is fatal in over 90% of cases; untreated bubonic plague is~     fatal in over 50% of cases. Delayed and ineffectual treatment is a main contributor to~     elevated case fatality rates, which can be as high as 40%, and to the development of~     pneumonic plague and plague outbreaks.~      Streptomycin is considered the treatment of choice, and prompt administration can reduce~     mortality to 5% or less. However, streptomycin may cause irreversible hearing loss and~     vestibular damage, reversible renal damage, and it is contraindicated during pregnancy.~     Tetracyclines, including doxycycline, are considered effective alternatives but they are~     bacteriostatic and relatively contraindicated for use in children aged < 8 years and pregnant~     women.~      Ciprofloxacin is a relatively newer antimicrobial that is used extensively in clinical~     practice because of its broad-spectrum antimicrobial activity, excellent tissue and~     intracellular penetration, suitability for oral administration, and good overall~     tolerability. In vitro and animal studies suggest equivalent or greater activity of~     ciprofloxacin against Yersinia pestis when compared with streptomycin or tetracyclines.~     However, the efficacy of ciprofloxacin for the treatment of human plague has never been~     demonstrated, nor is it FDA approved for this indication.~      Since 2004, CDC has collaborated with the Uganda Ministry of Health (MoH) and the Uganda~     Virus Research Institute (UVRI) to enhance surveillance, diagnosis, and ecological control of~     plague in Arua and Nebbi Districts. Through these efforts, we have collected data on over~     2,400 cases of clinically diagnosed plague occurring from 1999 through 2009. In 2008, UVRI~     and CDC staff investigated 163 suspect plague cases: 57 (35%) had laboratory-confirmed plague~     illness, of which 14 patients (25%) died.~      Because plague is a relatively rare disease that mainly affects people living in rural,~     impoverished areas, it receives limited attention for research and development of affordable~     and sustainable diagnostic and treatment options. However, because plague cannot be~     eradicated, and because it causes high case fatality and has the potential for widespread~     person to person transmission, continued research should not be neglected.~      The objective of this clinical trial is to conduct a randomized, open-labeled,~     non-inferiority study comparing the safety and efficacy of ciprofloxacin to doxycycline, the~     national treatment standard in Uganda for plague, in patients aged > 8 years. The primary~     outcome for this trial will be patient outcome 14 days from enrollment and initiation of~     treatment. Patient outcome will be evaluated only for those patients with~     laboratory-confirmed plague illness.~      Information gathered from this proposed study will help optimize management of naturally~     occurring plague in humans in many countries of the world, including Uganda and the United~     States, by providing clinicians with more choices for optimal antimicrobial treatment. This~     is particularly true in resource limited rural regions such as Uganda where intravenous or~     intramuscular injections are less available. Ciprofloxacin currently is being used in Uganda~     and other plague endemic areas of the world for treatment of other infectious conditions,~     including infectious diarrhea and lower respiratory infections. In Uganda, ciprofloxacin is~     widely available in health facilities and local drug shops, and is affordable.~   "
177375|NCT01243424|"~     The aim of the study is to investigate the longterm impact on cardiovascular morbidity and~     mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight~     and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated~     cardiovascular risk receiving usual care, and compare outcome against glimepiride.~   "
177376|NCT01243411|"~     This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in~     subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21~     days before the initial injection of study drug in the first treatment cycle.~      After up to four treatment cycles, each subject will be followed for additional safety and~     efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36).~      After the final injection of each treatment cycle, the investigator will model the plaque in~     an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to~     <15° after the first, second, or third cycle of injections or if the investigator determines~     further treatment is not clinically indicated (eg, adverse events; allergic reaction),~     subsequent treatment cycles will not be administered.~      Approximately 300 subjects will be enrolled.~   "
177377|NCT01243398|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether~     gefitinib is more effective than a placebo in treating esophageal cancer.~      PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works~     compared with a placebo in treating patients with esophageal cancer that is progressing after~     chemotherapy.~   "
177378|NCT01243385|"~     RATIONALE: Metformin hydrochloride may make some enzymes active. These enzymes may block~     other enzymes needed for cell growth and stop the growth of tumor cells.~      PURPOSE: This phase II trial is studying the safety of giving metformin hydrochloride as~     first-line therapy in treating patients with locally advanced or metastatic prostate cancer.~   "
177379|NCT01243372|"~     RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab~     may help doctors understand and predict how well patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in~     patients with advanced colorectal cancer.~   "
177380|NCT01243359|"~     This phase I trial studies the side effects and the best dose of sunitinib malate when given~     together with bevacizumab in treating patients with kidney cancer or advanced solid~     malignancies. Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth or by blocking blood flow to the tumor. Monoclonal antibodies,~     such as bevacizumab, can block tumor growth in different ways. Some block the ability of~     tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing~     substances to them. Giving sunitinib malate together with bevacizumab may kill more tumor~     cells.~   "
177381|NCT01243346|"~     This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of~     crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST.~   "
177382|NCT01243333|"~     This clinical trial studies multi-tracer positron emission tomography in patients with solid~     tumors. Diagnostic procedures, such as multi-tracer positron emission tomography, may help~     measure a patient's response to treatment.~   "
177383|NCT01243320|"~     Nanotechnology is the controlled generation and manipulation of matter in dimensions less~     than 100 nm. Silver has been used for its bactericidal properties. The investigators propose~     to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in human~     volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of this~     solution.~   "
177388|NCT01243255|"~     The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia in~     Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient~     treatment is defined as achievement of the LDL cholesterol level goals according to the~     European Society of Cardiology 2007 guidlines.~   "
177389|NCT01243242|"~     The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine~     (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD~   "
177390|NCT01243229|"~     The purpose of this study is to understand the genetic causes of congenital diaphragmatic~     disorders (CDD), namely congenital diaphragmatic hernia (CDH), eventration and hiatal hernia.~      Specifically, the investigators plan to:~        1. Ascertain informative families and sporadic cases with congenital diaphragmatic~          disorders and obtain appropriate phenotypic data and genetic material (peripheral blood~          and/or diaphragm tissue sample).~        2. Localize the gene(s) for CDD to specific chromosomal segments using linkage analysis,~          and determine the role of somatic mutations in CDD.~        3. Isolate and characterize genes involved in the pathogenesis of CDD.~        4. Develop molecular markers that will facilitate accurate diagnosis (including prenatal~          diagnosis) and permit correlation of phenotypic variation with specific mutations.~        5. Compare RNA-sequencing from tissue samples of children without CDH to those children~          with CDH.~   "
177391|NCT01243216|"~     The investigators are interested in determining the utility of ultrasound of the spine for~     labor epidurals or spinal anesthesia for women in labor or having a cesarean delivery. The~     investigators hypothesized that in women with poor spinal landmarks that the use of~     ultrasound of the spine will improve the process of placing labor epidurals or spinal~     anesthetics~   "
177392|NCT01243203|"~     The Objective of this study is to introduce a practically feasible multifaceted intervention~     in the preadmission clinic to help reduce smoking in preoperative surgical patients. The~     investigators aim to study the effectiveness of such a program in promoting positive change~     in smoking behavior among patients before surgery. The forced abstinence enforced on patients~     during hospital stay for their surgery can also be used to help smokers remain tobacco free~     long term. A significant percentage of surgical patients will be receptive to smoking~     cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52~     weeks after starting the treatment.~   "
177393|NCT01243190|"~     The goal of this clinical research study is to learn if ofatumumab can help to control~     CLL/SLL that has not yet been treated. The safety of this drug will also be studied.~   "
177394|NCT01243177|"~     Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR)~     as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint~     of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance~     between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).~   "
177395|NCT01243164|"~     Background and Rationale: Mobility impairment is one of the main correlates of decreased~     levels of participation in daily and social activities. Mobility disability is often~     remediable through the use of assistive technology, of which the wheelchair is arguably the~     most widely used and recognizable form. Statistics suggest over 250,000 Canadians use~     wheelchairs, the majority of whom are older adults.~      Mobility impairment often has psychological consequences that may independently restrict~     functioning and participation. Confidence is one such consequence, and according to Bandura's~     Social Cognitive Theory, is the belief individuals have in their ability to perform~     behaviours to achieve desired outcomes. Furthermore, previous findings have accounted for no~     more than 40% of the variance of factors influencing wheelchair mobility and participation.~     It is likely that confidence in wheelchair use may account for some of that variance. Recent~     findings show that approximately 40% of wheelchair users report having low confidence.~      Because confidence is client-specific and modifiable, treatment strategies to address low~     confidence in using a wheelchair may lead to greater participation among older adults.~      Purpose: The overall goal of this research project is to evaluate the efficacy of the~     Wheelchair Skills Training Program on confidence with using a manual wheelchair in a group of~     non-wheelchair users.~      Objectives:~        1. Evaluate the efficacy of the Wheelchair Skills Training Program on improving confidence~          with using a manual wheelchair.~        2. Evaluate the efficacy of the Wheelchair Skills Training Program on improving wheelchair~          performance.~        3. Explore the immediate effect of exposure to wheelchair skills (an outcome measure) on~          confidence using a manual wheelchair.~      Hypotheses:~        1. Participants who take part in the Wheelchair Skills Training Program will have~          significant improvements in confidence with using a manual wheelchair compared with~          those in the control group, as measured by the Wheelchair Use Confidence Scale~          (WheelCon)~        2. Participants who receive the Wheelchair Skills Training Program will have significant~          improvements in wheelchair performance compared to the control group, as measured by the~          Wheelchair Skills Test (WST).~        3. All participants will have significant improvements in confidence using a manual~          wheelchair after exposure to wheelchair skills (during baseline assessment).~      Research Method: This study will use 2 concurrent Randomized Controlled Trials to evaluate~     the efficacy of the Wheelchair Skills Training Program in younger and older adults. Trial 1~     and Trial 2 will employ different recruitment approaches for targeting younger versus older~     adults and different inclusion criteria with regard to age of the participants. Otherwise the~     research design, protocol and procedures will be the same. Upon completion of data~     collection, the data will be pooled and stratified by age (younger adult, older adult) for~     analyses.~   "
177396|NCT01243151|"~     The primary objective of this study is to evaluate the safety and tolerability of repeated~     doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an~     investigational drug that is currently being studied as a lipid lowering agent.~   "
177397|NCT01243138|"~     This is a cross-sectional, epidemiological study to determine the prevalence of~     cardiovascular risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and~     hypertension in patients attending General Practice clinics in the Africa and Middle East~     region. A total of 4300 patients will be evaluated. In patients who are found to have~     previously been diagnosed with cardiovascular (CV) risk factors such as dyslipidemia or~     hypertension, the level of control of their respective conditions will also be evaluated.~   "
177398|NCT01243125|"~     NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which~     exhibits the potential to prevent the growth of urinary pathogens, including Proteus and~     others.~      The use of a catheter irrigation solution that can prevent biofilm formation and encrustation~     leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes,~     potentially lower incidence of UTIs, and better patient quality of life.~      The study population will include male and female spinal cord injury (SCI) and other~     neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have~     a recent repeated history of urinary catheter encrustation and/or blockage.~      Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile~     irrigation solution and one treatment regimen with sterile saline irrigation solution. Each~     treatment regimen will consist of a total of 8 treatments, with a washout period between~     treatment regimens.~   "
177411|NCT01242943|"~     The aim of this Study Protocol is to provide a basis for the clinical development of~     131I-L19SIP as an anti-cancer therapeutic agent, following the promising results of a Phase I~     study.~   "
177558|NCT01240993|"~     A formal randomized efficacy trial testing the Mothers and Toddlers' program, an~     attachment-based parenting intervention for mothers enrolled in addiction treatment and~     caring for young children.~   "
177399|NCT01243112|"~     Purpose and Background The purpose of this research study is to investigate the benefits of~     mixing lidocaine and bupivacaine for numbing the skin. Lidocaine and bupivacaine are two~     commonly used medications to numb the skin for minor procedures. Lidocaine has a faster~     onset. Bupivacaine has a longer duration. They are often combined with epinephrine to~     increase the length of action. These medications are used to control pain at the time of the~     operation and to decrease discomfort immediately afterward. Participating in the study~     involves injection of local anesthetic containing lidocaine, bupivacaine, and lidocaine and~     bupivacain with epinephrine at 4 sites on the forearm. Your participation will potentially~     improve the administration of these medications in persons undergoing a variety of~     procedures. You will be one of approximately 25 healthy volunteer subjects in this research~     study.~   "
177400|NCT01243099|"~     The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to~     treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is~     supported by two different observations: first, when a DES is implanted to treat a BMS~     restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly~     characterized by extracellular matrix with a regular surface. In this case stent malposition~     is less likely to occur compared to atherosclerotic lesion whose surface is often more~     irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS~     implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is~     implanted to treat restenosis, reendothelialization is likely to occur earlier. If this~     hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES~     implantation on BMS restenosis with a clinical advantage in terms of bleeding risk.~     Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES;~     thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and~     to benefit from a shorter period of dual antiplatelet therapy.~   "
177401|NCT01243086|"~     In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of~     blindness. This disease was once thought to be a natural part of aging, but recent research~     has introduced effective treatments. ARMD is related to the body initiating an immune~     response in the eye, as if responding to an infection. Vision is impacted as ocular tissue~     becomes inflamed and new blood vessels form at the back of the eye, a process called~     angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels~     and impair the eye's structure and function. Many studies have shown that ranibizumab, a drug~     that stops the formation of new blood vessels (an anti-angiogenic agent) can delay damage to~     the eye and often restore vision. The investigators believe the best drug therapy will also~     stop the inflammation. OZURDEX, a steroid drug, has shown the potential to effectively reduce~     inflammation in this application. The investigators aim to investigate if patients receiving~     a combination treatment of ranibizumab and OZURDEX improve their visual abilities more than~     those receiving just ranibizumab treatment alone. Secondarily, the investigators will also~     investigate how often patients receiving each drug therapy regime require re-treatment and~     how often they experience further vision loss.~   "
177402|NCT01243073|"~     This is a phase II open-label study of single agent imetelstat in patients with essential~     thrombocytopenia or with polycythemia vera who have failed or are intolerant to at least one~     prior therapy, or who refuse standard therapy.~   "
177403|NCT01243060|"~     In recent years, there has been increased focus on cognitive side effects of sleep-inducing~     medications that may contribute to unusual behavior during unexpected awakenings during the~     night. Concerns regarding these side effects have led to a class Food and Drug Administration~     (FDA) warning for all sleep-inducing medications. Almorexant is an experimental~     sleep-inducing medication in a new class of medications that is being extensively developed~     by multiple pharmaceutical companies. Medications in this class block wake/arousal centers in~     the brain that function with proteins called hypocretins. The goal of this study is to~     evaluate the impact on cognitive performance of almorexant vs. zolpidem (an approved sleep~     aid) or placebo.~   "
177404|NCT01243047|"~     This is a randomized phase II study comprising of two treatment arms in patients who are~     previously untreated for metastatic or recurrent colorectal cancer.~   "
177405|NCT01243034|"~     The prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to~     be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients~     with MS have an increased incidence of DM, coronary heart disease and increased mortality~     from cardiovascular diseases. Central adiposity is highly correlated with the presence of~     hypertension, coronary heart disease, type 2 diabetes, and increased mortality risk. Waist~     circumference(WC) is a better indicator of abdominal obesity and a better predictor of CVD~     than either BMI or waist-to-hip ratio. However, currently there is no standard location for~     the measurement of WC.~      Objectives: 1. To compare the magnitude of WC measured at 3 sites ( immediately above the~     iliac crest, midpoint between the lowest rib and the iliac crest , umbilical level) in males~     and females.~      2. To examine the correlation of WC with Triglyceride, cholesterol, HDL, LDL and glucose.~   "
177406|NCT01243021|"~     At Bispebjerg Hospital we have introduced an Early Warning Score based triage system , called~     Bispebjerg Early Warning Score (BEWS), in order to identify critically ill patient on arrival~     at the emergency department. The purpose of this study is to validate our triage system.~   "
177407|NCT01243008|"~     IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent~     Lyme disease at early stages of infection after tick bite.~   "
177408|NCT01242995|"~     The purpose of this study is to evaluate the use of a thin scope/anchoring Balloon endoscopy~     system for the medical care of pancreatic and/or biliary disorders.~   "
177409|NCT01242982|"~     The purpose of this study is to find out the best treatment for subcapital and shaft~     fractures of the 5. metacarpal.~      It is a prospective randomized multicenter study. Comparing only fractures dislocated more~     than 30 degrees.~      One group will be operated with intramedullary pins and one group will be treated~     conservatively with reduction and then Plaster of Paris for 3 weeks.~      All patients will be followed up after 3, 6 and 12 months.~   "
177410|NCT01242956|"~     The study hypothesizes superiority of the video-based training (observation combined with~     motor exercise, video) over motor exercise alone (non-video) and standard rehabilitation~     (standard).~   "
177412|NCT01242930|"~     This is an open label Phase II study to determine the rate of improvement in response of~     patients with previously treated multiple myeloma to imetelstat alone or in combination with~     lenalidomide maintenance therapy. This study will include multiple myeloma patients who~     either have achieved disease stabilization or who have achieved at least a partial response~     (PR) but failed to achieve a complete response (CR) after cytoreductive therapy for multiple~     myeloma; ie, have detectable but non-progressing disease and will most likely relapse.~   "
177413|NCT01242917|"~     This is a randomized, double-blind, placebo-controlled, Phase 2 study to evaluate the safety~     and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to~     methotrexate therapy.~   "
177414|NCT01242904|"~     Peritoneal dialysis (PD) is the method of renal replacement therapy used by close to 200,000~     end stage renal disease patients worldwide to help replace the functions that are no longer~     performed by their kidneys. An important advantage of PD is it offers an alternative to~     hemodialysis that can be safely performed by patients in their own homes. In PD, the~     peritoneal membrane that lines the abdomen acts as a dialyzer that allows the transfer of~     solutes and water between the membrane capillaries and a dialysis solution that is infused~     into the peritoneal cavity. PD dialysis solutions typically require high concentrations of~     glucose to adequately perform these functions. Over time the continued exposure of the~     peritoneal membrane to high concentrations of glucose can permanently damage the membrane.~     Icodextrin is a polyglucose molecule that has been developed for use in PD solutions that~     does not harm the peritoneal membrane. However, its use can lead to inadequate fluid removal.~     Recent research has focused on finding a PD solution, or combination of solutions, that will~     maximize the removal of toxic substances and metabolites while maintaining regulation of~     fluid and electrolyte balance in the body. A bimodal solution that combines glucose and~     icodextrin has been shown in observational studies to be effective and safe. The~     investigators propose a randomized, controlled, blinded study that will determine the~     effectiveness and safety of this bimodal fluid in a Canadian PD population. The investigators~     hypothesize that the use of the bimodal solution during the long (day) dwell will lead to an~     improvement in 24 hour ultrafiltration efficiency as compared to usual care using icodextrin~     for the long dwell.~   "
177415|NCT01242891|"~     The main purpose of this protocol is to provide a mechanism for continued access for patients~     that would have been enrolled into the primary cohorts of the IDE study.~   "
177416|NCT01242878|"~     Sickle cell disease (SCD) is an inherited disorder of the red blood cell. It is now the~     commonest genetic disorder in the UK and of childhood stroke, with up to 40% of children~     having a stroke (clinical or picked up on a scan) by school age. Patients are prone to~     develop acute crises necessitating hospital admission and resulting in long-term~     complications. Such events result in considerable morbidity, disability and mortality with~     its consequent burden on patients, families, the health service and society as a whole.~     Doctors have very little ability to predict who will get ill and when and so it is very~     difficult to known when and how to administer treatments. Furthermore there is very little in~     the way of treatments available and the mainstay of prevention is a chronic blood transfusion~     programme which is expensive, requires time off work and school and can be fraught with~     complications. This, in a population who is frequently educationally and socially~     disadvantaged at the outset. Recent evidence in sickle cell disease and other diseases that~     have similar underlying processes, points towards the importance of microparticles~     (circulating broken pieces of cells) and the coagulation system as being important. By~     comparing levels of these particles and molecules in patients with those found in healthy~     volunteers and with other measures known to be important, this study hopes to identify their~     role so as to improve the management of these patients and potentially to lead the way for~     new therapies. Participants will be required to donate a small amount of blood (1 teaspoon in~     the very young, two in older children and adults). The investigators aim to take this sample~     where possible when people are having a blood test in any case.~   "
177417|NCT01242865|"~     The present study is designed to test the feasibility and efficacy of a stand alone self help~     program for decreasing stress and anxiety and enhancing quality of life. The intervention~     will be offered in the form of a self help book and three handouts with no in-person~     instructor time.~   "
177418|NCT01242852|"~     BACKGROUND: Despite the numerous advances in the field of in vitro~     fertilisation/intracytoplasmic sperm injection (IVF/ICSI), there still exists a maximum~     implantation rate per embryo transferred of about 30%. Next to the physiological and physic~     burden that comes with every IVF treatment cycle, implantation failure also adds up to the~     considerable costs associated with ART. Studies have shown, that minor intrauterine~     abnormalities can be found in 11-40% of the infertile women with a normal transvaginal~     sonography. Detection and treatment of these abnormalities by office hysteroscopy have led to~     a 9-13% increase in pregnancy rate. Therefore, it is increasingly advocated to screen all~     infertile women on intracavitary pathology prior to the start of IVF/ICSI.~      OBJECTIVE: The aim of the proposed study is to assess whether diagnosing and treating~     unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office~     hysteroscopy prior to a first IVF/ICSI treatment cycle improves the cost-effectiveness of the~     fertility treatment.~      STUDY DESIGN: Multicenter randomized intervention study. POPULATION: Asymptomatic women,~     indicated for a first IVF/ICSI treatment cycle and a normal transvaginal ultrasonography.~      INTERVENTION: Participants will be randomized for a (SIS and) hysteroscopy with~     treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up.~     In both groups standard IVF/ICSI treatment will be initiated.~      PRIMARY OUTCOME MEASURE:~      Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of~     IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos,~     as well as in subsequent cryo/thaw cycles)~      SECONDARY OUTCOME MEASURE:~        -  Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after~          randomization (obtained in both treatment cycles with fresh embryos, as well as in~          subsequent cryo/thaw cycles)~        -  Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization~          (obtained in both treatment cycles with fresh embryos, as well as in subsequent~          cryo/thaw cycles)~        -  Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment~        -  Patient preference and tolerance of a SIS and diagnostic/therapeutic hysteroscopy~          procedure~        -  Prevalence of unexpected intrauterine abnormalities~        -  Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities~   "
177448|NCT01242449|"~     This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks~     intervals in combination with trastuzumab as 1st and 2nd line treatment of women with~     metastatic HER2 positive breast cancer.~      Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic~     breast cancer, and capsules are generally better tolerated.~   "
177479|NCT01242033|"~     Eight healthy adult subjects will be given a meal of one, two or four cups red raspberries,~     or two slices white bread with or without 200 mg vitamin C, after an overnight fast and~     consumption of a low polyphenol diet for two days. Blood samples will be taken at various~     time points over an eight hour period to measure oxidative stress and antioxidant levels in~     the blood. Each subject will attend 5 study visits with one week intervals and be given each~     meal in a random order. It is hypothesized that raspberry consumption at higher doses will~     greater protect against meal-induced oxidative stress compared to bread controls.~   "
177419|NCT01242839|"~     CACICOL20 is a biodegradable nanopolymer engineered to mimic glycosaminoglycans such as~     heparan sulfates. Applied to the corneal lesion, it replaces damaged heparan sulfates in the~     matrix scaffold. CACICOL20 binds to matrix proteins such as collagen and cytokines or~     endogenous growth factors of the cellular microenvironment. CACICOL20 provides a protective~     function and restores the matrix architecture. This produces a suitable spatial environment~     for cells to respond properly to the cascade of signals needed for tissue regeneration to~     resume.~      The ophthalmic solution, CACICOL20, used for corneal ulcers is very well tolerated both~     locally and generally, as proved by a pilot study which as been conducted at the Hôpital des~     XV-XX in Paris (France). It reduces the pain significantly and increases corneal ulcer~     healing (all ulcers treated were resistant to all other usual therapies).~      Therefore, the accuracy of a Randomized multicentric double blinded study to evaluate the~     efficacy of CACICOL20 versus placebo for chronic corneal ulcer healing has been shown and~     will begin mid-may 2010. In this study, CACICOL20 will be applied every 2 or 4 days for 3~     months.~      The aim of the study is a double blinded comparison of complete chronic corneal ulcers~     healing rate within 3 months in 3 groups of patient double blinded randomized between~     CACICOL20 instillations distribution and physiological salt solution instillations~     distribution.~      The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete~     closure.~   "
177420|NCT01242826|"~     This trial is conducted in Asia. The aim of this clinical trial is to investigate the~     pharmacokinetic properties (the rate at which the trial drug is eliminated from the body)~     after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp~     50). In addition, the safety and tolerability of BIAsp 50 will be observed~   "
177421|NCT01242813|"~     This trial will assess the safety and efficacy of ACZ885 in patients with active recurrent or~     chronic TNF-receptor associated periodic syndrome (TRAPS).~   "
177422|NCT01242800|"~     RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery~     or radiation therapy may help patients with advanced breast cancer live more comfortably. It~     is not yet known whether early surgery is more effective than palliative therapy for advanced~     breast cancer.~      PURPOSE: This randomized phase III trial is studying early surgery to see how well it works~     compared to standard palliative therapy in treating patients with stage IV breast cancer.~   "
177423|NCT01242787|"~     The purpose of the study is to investigate the long-term safety and the antiviral activity of~     the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic~     hepatitis B infection compared to entecavir 0.5 mg.~   "
177424|NCT01242774|"~     This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat given~     3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with~     induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a~     cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of the~     combination in this regimen.~   "
177425|NCT01242761|"~     After comparing ultrasound study of rotator cuff injuries that have been evaluated both in~     the community and in a hospital-based ultrasound service with actual surgical findings, it is~     expected that specialist performed imaging and evaluation will be most accurate and that~     those performed in the community will be not accurate enough.~   "
177426|NCT01242748|"~     A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with~     the established therapy Zoladex 3 month implant in patients with prostate cancer.~   "
177427|NCT01242735|"~     The purpose of this study is to test the effect of a moderate-intensity aerobic exercise~     intervention for Obsessive Compulsive Disorder (OCD) patients interested in reducing~     symptoms. The investigators expect that this project will contribute much needed knowledge~     about the role that aerobic exercise can play in managing the effects of OCD. If~     moderate-intensity aerobic exercise is efficacious in helping individuals with OCD manage~     obsessions and compulsions, this will establish that aerobic exercise may be a valuable~     adjunct to other OCD treatments such as medication and therapy.~   "
177428|NCT01242722|"~     This study will collect data, from an implanted Cardiac Resynchronization~     Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart~     failure devices.~   "
177429|NCT01242696|"~     The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European~     Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the~     TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.~   "
177430|NCT01242683|"~     Physician-based primary care has thus far failed to address the obesity epidemic. In this~     randomized clinical trial of 200 obese patients with heart disease risk factors, the~     investigators will evaluate the impact of nurse and dietitian case management on weight loss~     and weight maintenance, as an adjunct to physician care. In addition, the investigators will~     test the incremental benefit of an environmental support strategy using community health~     workers to help patients navigate their home and neighborhood environments to achieve weight~     loss. The innovative intervention model developed and evaluated in this project has the~     potential to provide a blueprint for successful primary care-based obesity services~   "
177431|NCT01242670|"~     The purpose of the study is to verify the safety and adequacy of the immune response produced~     by a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine and to~     demonstrate the consistency of manufacture of 3 separate lots of RRV vaccine.~   "
177464|NCT01242241|"~     Obesity in children,as in adults,has rapidly become a public health concern. Studies in~     adults have shown that obesity, now considered to be a disease state, is a modifier of the~     effect of drugs on the body as well as how the body handles the drug.The anesthetic~     management of obese children poses a variety of significant challenges which include~     determination of the appropriate dose of anesthetic intravenous agents. Dosing of most drugs~     is calculated based on the effective dose in 50% of patients but the more practical and~     required information is the effective dose in 95%(ED95%)of patients. The aim of this study is~     to determine the effective dose in 95% of patients(children). The hypothesis is the ED95 of~     propofol in obese children will be higher than that of non-obese children.~   "
177465|NCT01242228|"~     This study is to evaluate long-term safety and efficacy after concomitant administration of~     ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.~   "
177432|NCT01242657|"~     The long term goal of the study entitled Quit & Fit was to revise, evaluate, and~     disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not~     On Tobacco (N—O—T), with an added physical activity module. The physical activity module was~     intended to encourage youth to adopt a more physically active lifestyle. Research showed that~     physical activity may increase the odds of smoking cessation. The general N—O—T program goals~     are to help adolescents quit smoking; reduce cigarette use (for participants who are unable~     to completely quit); increase healthy lifestyle behaviors; and improve life skills such as~     stress management, decision making, communication, and interpersonal skills. The primary aim~     of the current research project was to reduce smoking among West Virginia teens. A two—prong~     secondary aim was to (a) increase participants´ physical activity behavior by supplementing~     the intervention with a physical activity component and (b) assess the mediating/moderating~     impact of physical activity on cessation outcomes. If participants quit smoking, the~     likelihood that they will develop smoking—related diseases is diminished. Participating in~     this project may aid smoking cessation and therefore improve participants´ health. Research~     was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited~     to participate in the study over 3 years. This study is a clinical behavioral trial using a~     3-group design, with subsequent random assignment.~   "
177433|NCT01242644|"~     Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as~     effective as this solution plus ropivacaine administered intra-articularly for twenty-four~     hours.~      Three groups were assigned random patients, each group provided a different method of pain~     medication in order to determine the effectiveness of each treatment.~   "
177434|NCT01242631|"~     The purpose of this study is to determine whether the drug everolimus is effective in the~     treatment of patients with relapsed cancer of the testis. This is a phase II study where all~     patients will receive the study drug (everolimus 10 mg daily). The primary endpoint of the~     study is the rate of patients that have no progressive disease after 12 weeks of treatment.~     Twenty-five evaluable patients will be treated in this study.~   "
177435|NCT01242618|"~     The purpose of this study is to investigate the safety and feasibility of implanting an~     engineered cartilage graft, obtained by culturing expanded autologous nasal chondrocytes~     within a collagen type I/III membrane, in the alar lobule of patients after resection of a~     non melanoma skin cancer.~   "
177436|NCT01242605|"~     The objective of this study is to establish the recommended dose of selumetinib, a novel MEK~     inhibitor for use in combination with gemcitabine and cisplatin.~   "
177437|NCT01242592|"~     The purpose of the study is to evaluate the effect of homeopathy as an adjuvant to Anti~     tuberculosis treatment on sputum conversion, hematological, clinical sign and symptoms of~     relapsed Pulmonary TB.~   "
177438|NCT01242579|"~     The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and~     maraviroc gel and determine whether it is safe for daily use by healthy women in the United~     Kingdom~   "
177439|NCT01242566|"~     The management of glioblastoma in elderly patients with poor performance status (KPS<70) is~     unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and~     safety of temozolomide alone in this population~   "
177440|NCT01242553|"~     To demonstrate clinical substantial equivalence of iVue as comparable to commercially~     available RTVue.~   "
177441|NCT01242540|"~     Blood oxygen level dependant (BOLD) functional magnetic resonance imaging (FMRI)~     investigations of pain have provided substantial insight into the workings of the human~     brain. To date, however, the vast majority of studies have dealt with short painful~     stimulations. This work will expand the investigators knowledge of how longer stimulations~     are processed by comparing the activation pattern from a two minute painful stimulation with~     that of an 30-second painful stimulus. The investigators hypothesis that accommodation to the~     longer stimulation will be evident by either decreases in signal intensity in brain areas~     known to process pain, or by increasing activity in brain areas thought to be responsible for~     the modulation of painful perception.~   "
177442|NCT01242527|"~     The primary objective of the study is to determine the efficacy of Epanova (omefas) compared~     to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.~   "
177443|NCT01242514|"~     The purpose of this study is to evaluate the long term safety and tolerability of~     fostamatinib in patients with rheumatoid arthritis (RA).~   "
177444|NCT01242501|"~     This is a Phase IIB randomized trial to test a brief single session risk reduction counseling~     intervention on HIV and STI behavioral outcomes in Cape Town South Africa.~   "
177445|NCT01242488|"~     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and~     immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who~     have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.~   "
177446|NCT01242475|"~     A new, more specific skin test to detect tuberculosis has been developed by Statens Serum~     Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a~     positive test result will show as redness and/or swelling at the injection site, while a~     negative test will leave no reactions.~      The aim of this study is to test the C-Tb skin test in healthy adults previously BCG~     vaccinated to determine if healthy non tuberculosis infected individuals has a truly negative~     test result (this is called determining the specificity of the skin test). To be able to~     compare the new skin test with the current Tuberculin skin test volunteers will be injected~     with both the C-Tb and the TST skin test.~   "
177447|NCT01242462|"~     Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm~     infants. Despite improved survival of extremely premature infants with RDS, complications~     related to mechanical ventilation still occur. This trial will attempt to maintain adequate~     gas exchange at a rapid rate, short inspiratory time, low tidal volume, and low peak~     inspiratory pressure in infants with respiratory distress requiring mechanical ventilation. A~     cross over design will be used to test the hypothesis whether mid-frequency ventilation in~     preterm infants with RDS requiring mechanical ventilation will reduce the peak inspiratory~     pressure requirement when compared to conventional mechanical ventilation.~   "
177466|NCT01242215|"~     This study is to evaluate the efficacy and safety after concomitant administration of ASP1941~     and sulfonylurea in patients with diabetes mellitus.~   "
177449|NCT01242436|"~     Ovarian cancer is a gynecological cancer with a high risk of mortality. This is because the~     diagnosis is often been made in an advanced cancer stage with metastases throughout the~     peritoneum.~      An international study led by Prof. Dr. Ignace Vergote (Gynaecological Oncology) showed for~     the first time that patients in such an advanced stage of ovarian cancer who received first~     three neoadjuvant platinum-based chemotherapy regimens followed by interval debulking~     surgery, and in turn followed by at least 3 treatment with platinum-based chemotherapy, had~     fewer complications than patients treated with primary debulking surgery followed by~     chemotherapy. Moreover, the final survival rate in both groups seemed to be similar. The most~     important prognostic marker appeared to be whether patients with primary or interval surgery~     no longer had a visible residual tumor after the treatment. Patients who had only small~     metastases in the peritoneum, seemed to be better treated with primary surgery (neoadjuvant~     Vergote I, et al Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Crystallising, N~     Engl J Med 363 (1910): 943 - 953).~      Each patient with suspected advanced ovarian cancer should undergo a preoperative evaluation~     where they assess which of the two treatments is the best option.~      The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI) as a~     non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal~     metastases. This is to assess which of the two treatments (primary debulking surgery followed~     chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking~     surgery, followed in turn by chemotherapy) is the best option for a particular type of~     patient.~   "
177450|NCT01242423|"~     The study is to review whether musculoskeletal shockwave therapy (ESWT) can speed up the~     healing of second-degree burns as well as skin-graft donor sites.~      In both cases, the primary hypothesis is the shortened period leading up to the complete~     healing of the wound (reepithelization).~      The secondary hypothesis in the course of the study assesses:~      the rare manifestation of undesirable local events (e.g. reddening, swelling, hematoma).~   "
177451|NCT01242410|"~     Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in~     pregnant women with twins and a short cervical length at 18-22 weeks scan.~   "
177452|NCT01242397|"~     The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in~     patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for~     CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO~     per American Society of ECHO guidelines) and to show that CRT pacing is safe in these~     patients.~   "
177453|NCT01242384|"~     Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in~     pregnant women with short cervical length after an episode of threatened preterm labour.~   "
177454|NCT01242371|"~     The investigators intend to explore the hypothesis that symptoms of schizophrenia may be~     reduced by the administration of a probiotic supplement when used in addition to standard~     antipsychotic medications.~   "
177455|NCT01242358|"~     In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may~     occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an~     additional capnographic monitoring is subject of the study.~   "
177456|NCT01242345|"~     In this randomized controlled trial the utility of capnography and IPI gets evaluated.~     Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be~     prevented by an additional capnographic monitoring is subject of the study.~   "
177457|NCT01242332|"~     To prove pregabalin's efficacy and safety in Thai patients scheduled for arthroscopic ACL~     reconstruction~   "
177458|NCT01242319|"~     This quality improvement trial aims to evaluate whether giving patients information about~     their coronary heart disease risk via a computer kiosk in the doctors waiting room and~     providing primary care doctors with a personal digital device with a decision support tool to~     help with cholesterol management will improve cholesterol management compared to usual care.~   "
177459|NCT01242306|"~     This is a prospective, randomised study to compare the endothelial dysfunction of BMS vs SES,~     both implanted in the same patient with multiple de novo coronary artery lesions undergoing~     elective PCI. The primary end point will be the evaluation of endothelial dysfunction at 6~     months follow-up by measuring the change in vessel diameter in 5 points of the stent and~     peri-stent site after infusion of acetylcholine.~   "
177460|NCT01242293|"~     The purpose of this study is to determine that maternal hydration during labor with fluids~     containing glucose at a rate of 125 ml per hour does not affect the duration of labor~     compared to Ringer Lactate at a rate of 250 ml per hour.~   "
177461|NCT01242280|"~     In the last years, important advances have been done in the treatment and prevention of~     esophageal variceal bleeding. Experts agree that the combination of pharmacological and~     endoscopic therapy should be the first line therapy in the acute bleeding episode; whereas~     TIPS (transjugular intrahepatic portosystemic shunt) is considered a rescue therapy.~     Nevertheless, some patients would require different therapies to act as a bridge until~     definitive therapy can be instituted. Balloon tamponade (using the Sengstaken tube)~     represents, up to now, the most widely used temporary bridge to TIPS. However, balloon~     tamponade is associated with a high incidence of serious adverse events. Recently, the use of~     self-expanding metal stents have been introduced in the treatment of acute variceal bleeding~     showing a very high hemostatic efficacy with no adverse events. The present study is directed~     to compare the efficacy free of adverse events and mortality of self-expanding metal stents~     vs balloon tamponade in patients with variceal bleeding refractory to medical and endoscopic~     therapy.~   "
177462|NCT01242267|"~     The primary objective of this study is to:~      • Determine the maximum tolerated dose of thalidomide used in conjunction with dose-intense~     melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of~     patients who failed a prior treatment with dose-intense melphalan~      The secondary objectives of this study are to:~        -  Determine the toxicities resulting from administration of combinations of thalidomide,~          bortezomib and melphalan~        -  Determine the complete response (CR) and very good partial response (VgPR) rate in~          patients undergoing ASCT using thalidomide, bortezomib and melphalan~        -  Evaluate the treatment-free interval after treatment with the combination of~          thalidomide, bortezomib and melphalan~   "
177463|NCT01242254|"~     This study is designed to assess the efficacy and safety of multiple intravitreal injection~     of KH902 in patients with CNV due to AMD.~   "
177469|NCT01242163|"~     Discriminating irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD),~     especially with mild disease activity, is common clinical challenge. Most of the patients~     with suspected IBS have to go invasive procedures (colonoscopy/gastroscopy). In order to~     avoid invasive investigations, there is a search for noninvasive markers with the capacity to~     distinguish between IBS and IBD. Dr Hossam Haick (Department of Chemical Engineering,~     Technion) developed a system that combines nano-metals produced in his laboratory with~     electrical devices (transistors). The combination between a nanomaterial and an electrical~     transistor induces a change in its electrical behavior upon exposure to the material being~     examined; that is, a change in its electrical properties. The change in its electrical~     behavior is translated into a computerized graphic signal.~      The electronic nose is composed of an air pump, a filter for filtering external contaminants~     and an array of sensors. Each sensor transmits a signal according to the materials it knows~     how to identify. Thus, it is possible to characterize most of the substance families~     characteristic of a certain disease, and the same system is designed for differential~     diagnosis of different diseases.~      The purpose of the investigators study is to use the electronic nose to find bio-markers~     that will help to diagnose IBD and IBS without using invasive procedures.~      The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50~     controls). The patients included in the study will undergo an evaluation by a~     gastroenterologist after signing an informed consent and will answer a questionnaire.~      The samples will analyzed in the laboratory of Dr. Haick.~   "
177470|NCT01242150|"~     In critically ill pediatric patients with Acute Respiratory Failure (ARF), Noninvasive~     Continuous Positive Airway Pressure (NCPAP) is applied to avoid intubation and all related~     complications such as tracheal injury and predisposition to nosocomial pulmonary infections.~     The choice of the interface is one of the crucial issues affecting treatment outcome in~     pediatric age and in particular in preschool children in whom intolerance frequently~     compromise noninvasive respiratory treatment. NCPAP is applied either through nasal or facial~     tight fitting masks and the most important principle in guiding the selection of an interface~     is that it should fit comfortably. However, while nasal mask can leak gas when the infant~     opens his/her mouth, facial mask can cause significant gastric distension and vomiting, with~     risk of aspirating gastric contents. Moreover, complications such as air leaks, skin~     irritation on the bridge of the nose, and discomfort reported with nasal or facial masks in~     children frequently lead to interruption of the respiratory treatment. Thus, improving the~     interface between the patient and the ventilator would be expected to facilitate longer and~     more effective application of NCPAP.~      A new small helmet specifically designed for young infants has been recently introduced to~     administer NCPAP. In a recent short term crossover physiological randomized controlled trial,~     the investigators found that NCPAP by helmet was associated with enhanced feasibility, less~     need of sedation and prolonged application time (see references below). The purpose of this~     prospective randomized multicenter study is to compare the efficacy and feasibility of NCPAP~     delivered either by helmet or by facial mask to treat acute respiratory failure in infants~     admitted to Pediatric Intensive Care Unit (PICU).~   "
177471|NCT01242137|"~     Glibenclamide is metabolized by the hepatic enzyme P450 CYP2C9 to less active form.~     Polymorphism of this enzyme demonstrated clinical significance when examined on other drugs~     from the sulfonylurea drug family, to whom Glibenclamide is included.~      The investigators assumption is that patients with less active alleles of the enzyme may show~     lower dose requirements of the drug for glycemic control, when compared to patients~     homozygotes to wild-type alleles.~   "
177472|NCT01242124|"~     The purpose of this study is to determine the safety and efficacy of the side-to-side stapled~     intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.~   "
177473|NCT01242111|"~     This multicenter, open-label extension study is designed to assess long-term efficacy and~     safety of 2.0 milligrams (mg)/kilogram(kg)/week of BMN 110 in patients diagnosed with~     Mucopolysaccharidosis IVA (MPS IVA). Patients with MPS IVA, who enrolled in a prior BioMarin~     sponsored clinical study of BMN 110 (NCT00884949; Study Identification Number MOR-002), were~     eligible to enroll in this study (except patients who enrolled in NCT01275066; Study~     Identification Number MOR-004).~   "
177474|NCT01242098|"~     The purpose of this study is to evaluate whether beclomethasone dipropionate / formoterol~     (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to~     fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients~     switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared~     with patients not switched.~   "
177475|NCT01242085|"~     The hypothesis of this study is that total knee alignment will be improved by preoperative~     planning from CT scans and the production of custom instruments compared to the use of~     standard instruments.~   "
177476|NCT01242072|"~     This an an open-label study to define the safety profile and the maximum tolerated dose and~     confirm the clinical effective dose of palifosfamide-tris given intravenously in combination~     with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are~     normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study~     using the 3 agents combined will begin.~   "
177477|NCT01242059|"~     It is hypothesized that yellow pea protein and fiber will reduce short-term food intake,~     subjective appetite and glycemic response.~   "
177478|NCT01242046|"~     The key research question in this study is whether or not caffeine facilitates genital sexual~     arousal in women in the presence of an external erotic stimulus. Caffeine's impact on the~     human sexual response cycle has yet to be studied in the field, so the goal is to determine~     if this substance will have any impact on genital arousal well as potentially identify the~     mechanisms underlying its ability to do so. Considering that this will be a single blind~     study, a key goal of the project is to determine how participant expectations regarding what~     they ingest will impact their subjective sexual arousal. At present, we hypothesize that, as~     caffeine's stimulant properties increase a human's heart rate and blood pressure, caffeine~     intake will facilitate genital arousal.~   "
177507|NCT01241669|"~     This is a drug-drug interaction study to evaluate the effects of steady-state exposure of~     E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation~     transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of~     E5555 on several renal function parameters.~   "
177480|NCT01242020|"~     The purpose of this study is to test a method of imaging (taking a picture) of the abdomen~     (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a~     drug which makes the pictures look clearer. Ultrasound is a type of imaging that uses sound~     waves to create a picture of the inside of the human body. Two sets of pictures will be taken~     on two different days to see if the results are the same each time.~      DEFINITY® is a drug given intravenously (through the vein). DEFINITY® is approved by the FDA~     to be used as an ultrasound contrast agent (makes the pictures look clearer) while taking~     pictures of the heart. In this study, DEFINITY® will be used while taking pictures of blood~     vessels in your abdomen (belly), neck, thigh and calf (lower leg). Since this use of~     DEFINITY® is different than the use approved by the FDA, this study will be performed under~     an FDA Investigational New Drug (IND) application.~   "
177481|NCT01242007|"~     Myotonic dystrophy Type 1 (MD1, Steinert's disease), an autosomal dominant multisystem~     disease, is of the most common muscular dystrophies in adults, with a European prevalence of~     3-15/100 000. The disease course is progressive, associating muscular weakness, wasting and~     myotonia. Respiratory dysfunction is common, involving a restrictive ventilatory abnormality~     and alveolar hypoventilation, originating from respiratory muscle weakness. Depending on the~     degree of impairment of their lung function, the quality of life and the prognosis of MD1~     patients may be very variable. However, time course and prevalence of such respiratory~     function impairment have not been clearly identified. More importantly, factors able to~     predict poor respiratory outcome have not been defined and therefore early prognosis can not~     be assessed during the follow-up of these patients. In other neuromuscular disorders,~     especially Amyotrophic Lateral Sclerosis (ALS), postural spirometry has been recommended to~     improve the detection of diaphragmatic involvement and some authors have suggested that the~     supine fall in the forced vital capacity could be used to initiate noninvasive positive~     pressure ventilation and predicts some respiratory symptoms.~      In a sample of ambulatory patients with MD1, our study was designed to prospectively achieve~     two aims: 1) to assess the respective prevalence of a ventilatory restrictive pattern,~     respiratory muscle weakness, hypoxemia and hypercapnia and 2) to evaluate whether postural~     changes in lung volumes contribute to sensitize the diagnosis of respiratory weakness and~     could be used as a predictor of poor respiratory function, including hypoxemia, hypercapnia~     and restrictive ventilatory disease.~   "
177482|NCT01241994|"~     AASD is a new dialysis technique based on the use of a mathematical model of intradialytic~     solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and~     ultrafiltration rate profile. The aim of dialysate sodium and ultrafiltration rate profile is~     to obtain the higher stabilization of intradialytic extra cellular compartment, in~     consideration of end session targets: body weight and final patient's natremia. In this~     multicenter prospective controlled randomized trial the primary end-point is the clinical~     efficiency validation of AASD on intradialytic hypotension but also on thirst, cramps,~     headache, nausea, vomiting, hypotensive events observed in basal treatment (HD or HDF).~   "
177483|NCT01241981|"~     This study will examine a new imaging technique called digital breast tomosynthesis (DBT)~     compared to standard mammography in women under 60 presenting with signs of breast cancer.~     The reason that we need to do this study is that standard mammography fails to detect the~     cancer in approximately 20% of these women because younger women have denser breast tissue.~     We hope that DBT will be more sensitive in detecting breast cancer than standard mammography.~   "
177484|NCT01241968|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients~     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.~   "
177485|NCT01241955|"~     To compare the decision making of family members of patients admitted to the ICU in regards~     to their CPR preferences for their loved ones with and without the use of a video decision~     aid.~   "
177486|NCT01241942|"~     The purpose of this research study is to perfect the technique of EVLP and learn about the~     safety of transplanting lungs that have been ventilated (attached to a breathing machine or~     ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™,~     made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in~     a modified cardiopulmonary bypass circuit (the kind of device used routinely during most~     heart surgeries). The purpose of performing ex-vivo lung perfusion and ventilation (EVLP) is~     to learn how well the lungs work, and whether they are likely safe to transplant.~   "
177487|NCT01241929|"~     To compare the decision making of subjects with advanced cancer having a verbal advance care~     planning discussion compared to subjects using a video.~   "
177488|NCT01241916|"~     Primary Question: When splinting is used to improve motion in post-traumatic stiff elbows,~     is there a significant difference in gains in motion achieved between static progressive or~     dynamic splint approaches?~      Secondary Question: Is there a significant difference in patient compliance with static~     progressive versus dynamic splint use, and does this effect final ulnohumeral motion~     outcomes?~   "
177489|NCT01241903|"~     The central hypothesis for this work is that platelet - leukocyte interactions play a~     critical role in the pathogenesis of acute ischemic events. The primary objective of the~     study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor~     rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention~     exerts beneficial vascular effects by reducing platelet - leukocyte interactions.~   "
177490|NCT01241890|"~     Pulmonary exacerbations of CF are an important cause for the experienced disability of~     patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic~     therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is~     important. The aim of this study was to assess the predictive properties of inflammatory~     markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the~     reliability of home monitor assessments of symptoms and lungfunction was investigated.~   "
177521|NCT01241474|"~     The purpose of this study is to determine whether a prolonged (9 month) high (6g/d) of marine~     oil improves insulin sensitivity and glucose control in subjects with impaired glucose~     regulation.~   "
177522|NCT01241461|"~     The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese~     patients with advanced and/or metastatic solid tumors for which no proven effective therapy~     exists.~   "
177491|NCT01241877|"~     Background of the study:~      Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown in~     animals and humans. Exercise enhancing effects have been shown in animals via enhancement of~     fat oxidation. We want to examine the effects of 4 weeks of astaxanthin supplementation on~     fat oxidation and cycling performance in trained cyclists~      Objective of the study:~      To test the hypothesis that 4 weeks supplementation with astaxanthin will improve fat~     oxidation and improve exercise performance in trained cyclists~      Study design:~      Double blind, placebo controlled study.~      Study population:~      Well trained cyclists between 18-30 years old~      Intervention (if applicable):~      astaxanthin (20 mg/day) or placebo for 4 weeks~      Primary study parameters/outcome of the study:~      performance on a time trial after 90 min steady state exercise.~      Secundary study parameters/outcome of the study (if applicable):~      substrate use plasma glucose plasma lactate plasma free fatty acid plasma astaxanthin~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness (if applicable):~      The risks involved in participating in this experiment are minimal. Astaxanthin has been~     shown to be safe. Insertion of the catheters in a vein is comparable to a normal blood draw~     and the only risk is of a small local haematoma.~   "
177492|NCT01241864|"~     The purpose of this study is to learn about the safety of islet transplantation when~     performed after kidney transplantation, which may provide more normal control of blood sugar~     without the need for insulin shots. Islets are special clusters of cells within the pancreas~     that produce insulin. These cells will be obtained from cadaver (non-living) donors and given~     to subjects by vein.~   "
177493|NCT01241851|"~     To determine whether acute aerobic exercise versus resistance exercise effects cognitive~     function among older adults.~   "
177494|NCT01241838|"~     The purpose of this study is to compare the effect of heart rate on cardiac index in patients~     with or without left ventricular hypertrophy. The study will be conducted in postoperative~     heart surgery patients with a pacemaker.~   "
177495|NCT01241825|"~     The purpose of this study is to see if chewing sugarless chewing gum alters the time it takes~     for a capsule endoscopy to travel through the stomach and small bowel, and to see if~     more/less capsule endoscopes reach the large bowel.~   "
177496|NCT01241812|"~     High joint load during walking has been linked to cartilage degradation. Biomarkers, found in~     the blood and urine, are protein fragments released after cartilage degradation~     characteristic of OA. They have the potential to enable direct and immediate disease state~     monitoring and identification of early cartilage changes. Little is known about the~     association of biomarkers with joint load or if exercise aimed at reducing joint load changes~     biomarker levels, thus reducing the risk of OA progression. This study will provide novel~     information on these relationships and will guide future intervention studies. The~     investigators hypothesize that certain biomarkers will be highly correlated with joint~     loading during walking and that the levels of these biomarkers in the blood and urine will~     decrease following an exercise intervention aimed at cartilage unloading.~   "
177497|NCT01241799|"~     Purpose:~      To compare the diagnostic yield of endoscopic ultrasound guided fine needle aspiration biopsy~     (EUS-FNA) in patient with pancreatic masses with and without the use of a stylet in place~     within the biopsy needle.~      Hypothesis:~      In patients undergoing an EUS FNA for pancreatic indications, patients having a fine needle~     aspiration biopsy (FNA) without the internal stylet will have a greater diagnostic yield~     compared to those with the internal stylet.~      Justification:~      EUS-FNA is an increasingly important means of obtaining tissue samples from lesions within~     the thorax and abdomen. In experienced hands EUS-FNA is a safe alternative to more invasive~     procedures such as mediastinoscopy or laparoscopy. EUS-FNA can be used for sampling suspected~     cholangiocarcinoma, pancreatic masses or cysts, submucosal gastric lesions, peripancreatic,~     perigastric or mediastinal lymph nodes and in some cases adrenal or liver masses. Therefore,~     it is a powerful tool for both diagnosis and tumour staging. For example, for the diagnosis~     of pancreatic adenocarcinoma, which is a common indication for EUS-FNA, the sensitivity~     varies from 75 to >90%, with a specificity of 82-100% and a mean accuracy of 85%. Improving~     the diagnostic yield may lead to an earlier diagnosis with a reduced number of investigations~     and earlier institution of treatment for the patient.~      The FNA needle system consists of a 22 or 19 gauge needle which is manipulated by a handle~     piston that attaches to the biopsy channel of the endoscopic ultrasound (EUS) linear scope.~     The tip of the needle has grooves to disperse ultrasound waves making the tip of the needle~     easily seen. The sample is taken by inserting a specially designed needle into the area of~     interest under EUS guidance. Inside the needle is a removable stylet with a rounded or~     bevelled tip to facilitate the passage of the needle into the tissue. The usual practice is~     for the stylet to be extracted after the needle has been passed into its optimum position~     within the tissue and for it to be re-inserted before each pass. However, a recent~     prospective trial with 111 patients, published in abstract form, found this approach was~     associated with a significant reduction in the proportion of adequate samples compared to~     when the stylet was removed before passing the needle. Although there was no significant~     difference in the diagnostic yield between the two groups this study raises the issue that~     the stylet left in place is to the detriment of the tissue sample and, ultimately, may reduce~     the diagnostic yield or increase the number of passes needed to obtain a satisfactory sample.~      One limitation to this study includes the heterogenous patient population. Yields of EUS-FNA~     vary considerably depending on the type of tissue being biopsied. The second limitation is~     that consecutive patients were randomized to having the stylet removed versus having the~     stylet not removed at the time of FNA. There is no control group from which to compare the~     two groups. An improvement in the study design would be to have each patient to be their own~     control group. Successive passes of the FNA needle can increase the bloodiness of the sample,~     so randomization of the order in which each group is done will help eliminate potential bias.~      It is clear from the current published literature that removing the stylet increases the~     cellularity of the sample. However, this increased cellularity may be the result of more~     contamination from the GI tract through which the FNA needle needs to pass in order to get an~     extra-luminal sample. Blood or a traumatic FNA can also lead to increased cellularity that~     can compromise diagnostic accuracy.~      Diagnostic yield depends on both adequacy of the sample and enough cells from the lesion to~     interpret. A preliminary result based on an air dried slide often can lead to fewer FNA~     passes if a diagnosis can be made. If this is not possible, a cell block preparation is made~     from all the washings from the EUS-FNA needle. No study has examined the diagnostic accuracy~     of these two types of samples using an EUS-FNA needle with and without the stylet within the~     same patient.~      Objectives:~      To determine if the diagnostic yield of EUS-FNA is increased if the stylet is removed from~     the FNA needle compared with leaving it in place.~   "
177498|NCT01241786|"~     To determine the response to the combination of azacitidine + lenalidomide in patients with~     relapsed/refractory CLL and SLL~      Hypothesize - lenalidomide's activity in combination with azacitidine may further enhance its~     activity and the durability of treatment response.~   "
177499|NCT01241773|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 on the steady-state pharmacokinetics of efavirenz or raltegravir , and vice versa.~     Steady state is a term which means that the drug has been given long enough so that the~     plasma concentrations will remain the same with each subsequent dose. TMC435 is being~     investigated for the treatment of chronic hepatitis C virus (HCV) infection. Efavirenz and~     raltegravir are two antiretroviral drugs for treatment of human deficiency virus (HIV)~     infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream,~     distributed in the body and eliminated from the body.~   "
177500|NCT01241760|"~     The purpose of this study is to evaluate the effectiveness of telaprevir administered twice~     daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in~     treatment-naïve participants with chronic HCV genotype 1 infection.~   "
177501|NCT01241747|"~     Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in~     exercise performance, peripheral vascular function, and health-related quality of life than~     compared to the attention-control group.~      Hypothesis #2. The change in peripheral vascular function will be predictive of improved~     exercise performance following the supervised exercise program.~   "
177502|NCT01241734|"~     The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the~     patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the~     RICE therapy and again after transplant as maintenance. To improve over all outcome and~     survival.~      Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall~     response rate thus increasing the number of patients able to proceed with autologous stem~     cell transplant. This in turn may translate into improved overall survival and progression~     free survival.~   "
177503|NCT01241721|"~     The purpose of the study is to determine the optimal, lowest dose of radioactive tracer~     required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in~     pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating~     breast-conserving surgery but identified to have a second unsuspected breast cancer by MRI.~   "
177504|NCT01241708|"~     High dose chemotherapy with stem cell transplantation is commonplace in the treatment of~     multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used~     in several thousand bone marrow transplant recipients worldwide for the same or similar~     disorders.~   "
177505|NCT01241695|"~     The purpose of the study is to determine the safety, acceptability and the efficacy of a~     12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic~     control in type 2 diabetic patients with or at risk of malnutrition~   "
177506|NCT01241682|"~     Earlier the investigators determined the safety and feasibility of tumor lysate-pulsed~     dendritic cells as therapeutic adjuvants in mesothelioma patients. Because pre-clinical data~     in mice had shown that better results were obtained when regulatory T cells were depleted~     using low-dosis of cyclophosphamide, ten patients who responded on chemotherapy are selected~     for DC-treatment in combination with Endoxan.~   "
177508|NCT01241656|"~     In this study we will compare 3 strategies for systematic delivery of prostate cancer~     screening decision support interventions (DESI) to usual care and examine their impact on~     screening decisions and subsequent healthcare utilization using a randomized control design.~      We hypothesize men who are given the opportunity to review a DESI by one of the 3 strategies~     will be less likely to opt for prostate cancer screening, and will have lower subsequent~     healthcare utilization than men in the control group.~   "
177509|NCT01241643|"~     This is a Phase II multicenter, open-labeled, controlled, randomized study assessing weekly~     doses of Interleukin-7 (CYT107)~   "
177510|NCT01241630|"~     Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder~     dysfunction. Recently, the concept of a surgically created somat-sensory reflex arch for~     bladder dysfunction in SCI has been introduced. The concept is promising, not just for~     bladder but also for bowel dysfunction. However, well designed studies need to be performed~     before recommending the procedure to a large number of patients worldwide. In this study we~     perform multidisciplinary studies providing necessary information about the clinical outcome~     of the somato-sensory reflex arch in adult SCI patients.~      The hypothesis is as follows:~        1. In a western setting the somato-sensory reflex arch can be created in adult SCI~          patients with only minor morbidity and complications.~        2. Somato-sensory reflex arch reduces bladder and bowel symptoms in SCI patients.~   "
177511|NCT01241617|"~     The objective of this study is to confirm superiority between a test treatment group using~     Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international~     standard of care group using a conventional stapler in patients undergoing pulmonary~     lobectomy surgery, using a randomized comparative study of the frequency of intraoperative~     air leak.~   "
177512|NCT01241591|"~     To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550~     for treatment of moderate to severe chronic plaque psoriasis.~   "
177513|NCT01241578|"~     Standard behavioral treatment (SBT) for obesity is often effective, but weight losses are~     highly variable, and patients sometimes fail to achieve a successful weight loss of 5-10%~     of their starting weight. It has been suggested that the one size fits all approach of SBT~     may be responsible for many treatment failures because the intervention is not sufficiently~     tailored to address the unique needs of each patient. Moreover, treatment is delivered in the~     clinic, not in the settings and the times when it is needed most. The primary aim of the~     proposed research is to develop and pilot test a behavioral weight loss intervention that~     combines in-person sessions with treatment delivered via an electronic handheld device to~     provide highly individualized weight loss treatment in patients' natural environment. In a~     critical departure from previous research using cell phone technology, the portion of~     intervention that is delivered via handheld device will be of equal sophistication and~     importance to the portion of the intervention that is delivered in face-to-face treatment~     sessions. The proposed study seeks to determine the feasibility and preliminary efficacy of~     an individually tailored behavioral weight loss program that integrates clinic-based care and~     smartphone technology.~   "
177514|NCT01241565|"~     The objectives of this clinical trial are to compare the incidence and duration of air leaks~     and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic~     Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in~     a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).~   "
177515|NCT01241552|"~     This study will investigate whether: 1) treatment with MK-3415A in addition to standard of~     care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence~     as compared to treatment with MK-6072 or MK-3415, 2) treatment with MK-3415A, MK-6072, or~     MK-3415, in addition to SOC antibiotic therapy will decrease CDI recurrence as compared to~     placebo, and 3) MK-3415A, MK-6072, and MK-3415 will be generally well tolerated in~     participants receiving SOC therapy for CDI as compared to placebo.~   "
177516|NCT01241539|"~     The current study will allow the assessment of pharmacokinetics, pharmacodynamics,~     elimination rate and clearance of dabigatran etexilate during and following haemodialysis in~     ESRD patients.~   "
177517|NCT01241526|"~     The goal of the study is to evaluate a Home-Based Disease Management program specifically~     developed for patients with Gold III/IV COPD.~      By improving disease knowledge, awareness of significant clinical deterioration and~     self-management skills for patients, this Home-Based COPD Management Program is expected to~     reduce the severity of exacerbations, the need for emergency hospitalisations, thus~     demonstrating the efficacy and the cost effectiveness of this intervention.~   "
177518|NCT01241513|"~     The main purpose of this study is to determine if a drug (acetyl-cysteine or ACCY) can~     increase the amount of oxygen in your body at a high altitude of 11,500 feet. ACCY is~     approved by the Food and Drug Administration (FDA) as a treatment or antidote for Tylenol~     overdoses. Other forms of ACCY are also sold over-the-counter as nutritional supplements. In~     this study, the FDA-approved form of ACCY will be used off-label (meaning in a way not~     approved by the FDA).~      This study is being conducted by researchers from the United States Army Research Institute~     of Environmental Medicine (USARIEM). The study will take place in the Altitude Chamber~     located in the basement of USARIEM. A total of approximately 30 volunteers (men and women,~     military and civilians) will take part in the study. They can expect to be in the study for a~     minimum of a few hours each day for two weeks.~      The investigators hypothesize that ACCY will improve ventilation and oxygenation while at~     altitude.~   "
177519|NCT01241500|"~     The primary objective of this study is to compare overall survival (OS) in patients receiving~     ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of~     patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow~     blasts) who have failed azacitidine or decitabine treatment. This patient population has no~     available therapy and a short life expectancy (approximately 4 months). The high level of~     bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to~     delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant~     and severe complication, which shortens survival of these MDS patients.~   "
177520|NCT01241487|"~     This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in~     hypertensive patients uncontrolled by monotherapy.~   "
177524|NCT01241435|"~     The purpose of this study is to evaluate the effect of liver function on how much of the~     study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid~     of it. Information about any side effects that may occur will also be collected.~      The duration of participation in this study is approximately 12 days not including the~     screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1~     outpatient follow-up visit. A screening visit is required within 30 days prior to the start~     of the study. This research study will be an open label study.~      The study involves a single oral dose of 18 mg LY2216684 given as 2 tablets.~   "
177525|NCT01241422|"~     The purpose of this study is to evaluate the allergen-induced late asthmatic response (LAR),~     as measured by maximal percent fall in forced expiratory volume in 1 second, in participants~     with stable mild atopic asthma after treatment with JNJ 40929837 as compared to placebo.~   "
177526|NCT01241409|"~     The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2~     sprinkle capsule formulations of rabeprazole sodium when administered without food to healthy~     volunteers. In addition, the pharmacokinetics of 1 formulation of rabeprazole sodium will be~     evaluated when administered with food to healthy volunteers.~   "
177527|NCT01241396|"~     The primary objective of this observational study is to document and describe current~     treatment regimens and disease progression of patients with Multiple Myeloma (MMY). The aim~     of this registry is to provide accurate, descriptive information on the way Multiple Myeloma~     is treated in routine clinical practice. The registry will collect information related to the~     treatment received for Multiple Myeloma. About 3000 patients will take part in the study in~     about 28 countries. The registry will only collect information that is already in medical~     files regarding treatment. Patients will not be required to actively do anything in addition~     to what would be done without participating in this registry, nor will there be any~     procedures or interventions that are not already part of the current treatment.~   "
177528|NCT01241383|"~     Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen~     deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular~     phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of~     patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting~     enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of~     the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic~     improvement, SRC remains a severe manifestation of SSc and functional outcome and survival~     remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that~     has recently been approved for the treatment of primary pulmonary arterial hypertension and~     for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on~     others vascular injuries and particularly in SRC.~   "
177529|NCT01241370|"~     The purpose of this study is to investigate microvascular endothelial function in the retina~     of lean, obese, and type 2 diabetic subjects and to compare microvascular endothelial~     function in the retina with several other established markers of endothelial and~     microvascular function.~   "
177530|NCT01241357|"~     The proposed research project will continue the application and development of a new method~     (biomagnetic susceptometry) that measures magnetic fields to determine how much iron is in~     the liver. The amount of iron in the liver is the best indicator of the amount of iron in the~     whole body. Measuring the amount of iron in the body is important because either too much~     (iron overload) or too little iron (iron deficiency) can be harmful. At present, the most~     reliable way to measure the amount of iron in the liver is to remove a sample of the liver by~     biopsy, either by surgery or by using a needle which pierces the skin and liver. Iron stored~     in the liver can be magnetized to a small degree when placed in a magnetic field. In patients~     with iron overload, the investigators previous studies have shown that magnetic measurements~     of liver iron in patients with iron overload are quantitatively equivalent to biochemical~     determinations on tissue obtained by biopsy. In the past the investigators have developed a~     device to measure the amount of magnetization, which was called a SQUID (Superconducting~     QUantum Interference Device) susceptometer. This device was validated and in use for over 20~     years. The safety, ease, rapidity and comfort of magnetic measurements make frequent, serial~     studies technically feasible and practically acceptable to patients. The investigators have~     now developed a new susceptometer, which uses very similar technology to the SQUID, but the~     investigators believe is more accurate and precise. This study aims to validate this new~     instrument. The investigators will do prospective, serial studies of the diagnosis and~     management of patients with iron overload, including thalassemia major (Cooley's anemia),~     sickle cell disease, aplastic anemia, myelodysplasia, hereditary hemochromatosis, and other~     disorders. Funding Source - FDA OOPD.~   "
177531|NCT01241344|"~     The primary objective of this study is to evaluate the safety and efficacy of preemptive~     treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT~     with asymptomatic AdV viremia.~   "
177532|NCT01241331|"~     The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to its~     vehicle in the treatment of moderate-severe acne vulgaris.~   "
177533|NCT01241318|"~     This will be a cluster-randomized controlled trial to assess whether washing the umbilical~     cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when~     compared to the current standard of care, dry cord care.~   "
177534|NCT01241305|"~     The purpose of this study is to identify genes that increase the risk of developing~     vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of~     these studies will provide vasculitis researchers with insight into the causes of these~     diseases and generate new ideas for diagnostic tests and therapies, and will be of great~     interest to the larger communities of researchers investigating vasculitis and other~     autoimmune, inflammatory, and vascular diseases.~   "
177535|NCT01241292|"~     The purpose of this study is to assess the safety and tolerability of Elotuzumab when given~     in combination with Lenalidomide and low-dose Dexamethasone in subjects with relapsed or~     refractory multiple myeloma (MM) in Japan.~   "
177536|NCT01241279|"~     The objective of this study is to demonstrate the correlation of near vision and changes in~     higher order aberrations following lens extraction and to characterize the defocus curves of~     Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in~     adults.~   "
177559|NCT01240980|"~     The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose~     control of BMS-903452 compared to placebo in healthy subjects & relative bioavailability of~     the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 & 12(Part A)] ; and subjects~     with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of~     BMS-903452 in the blood.~   "
177560|NCT01240967|"~     The purpose of this study is to compare the absorption and distribution of a single oral dose~     of TC-5214 in subjects with renal impairment and with subjects with normal renal function.~   "
177537|NCT01241266|"~     This will be a multicenter prospective observational study carried out in China. The~     investigators will collect data in a pre-specified Case Report Form. Main data from each~     patient will include demographics, endoscopy classification, and both endoscopy and~     pharmacological treatments received by patients. Data from each patient will be prospectively~     collected from the day the patient is diagnosed as peptic ulcer bleeding by endoscopy and~     receives endoscopy treatment if the investigator thinks it is needed and up to 30 days~     afterwards. The proportion of peptic ulcer bleeding patients who are at high risk is the~     primary outcome variable. High risk is defined as the patients with endoscopy Forrest~     classification Ia to IIb. The rate and type of endoscopic treatment, the rate of successful~     endoscopy treatment, the re-bleeding rate and the endoscopic re-treatment rate in high risk~     peptic ulcer bleeding patients will be collected. The surgery rate and mortality rate in high~     risk and overall patient population will be calculated.~   "
177538|NCT01241253|"~     The study uses a randomized, placebo-controlled experimental design consisting of 4 different~     test treatments matched on carbohydrate (CHO) content. The three beans are similar in their~     CHO content amount for ½ cup at ~20 grams CHO. Each of the bean varieties will be served in a~     ~½ cup serving size with ~ ½ cup of plain steamed white rice (30 grams CHO) for a total of 50~     grams of CHO per meal for each of the three test treatments. The 4th placebo or control~     treatment consists of ~ 7/8 cup of rice alone, an amount consistent with the CHO content of~     the test meals. Most diabetic meal plans recommend no more than 45-60 grams of CHO per meal.~     Fifty grams of CHO is a standard amount for glycemic response testing in general.~      The investigators hypotheses were:~        -  The test meals containing the three bean types in combination with white rice will~          decrease the participants' glycemic response when eaten as part of a meal.~        -  The reduction in post-prandial glycemia will not differ between bean types in the~          elicited responses among individuals with type 2 diabetes.~   "
177539|NCT01241240|"~     This study will evaluate the safety and efficacy of Triple Combination Therapy compared with~     Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary~     open-angle glaucoma or ocular hypertension.~   "
177540|NCT01241227|"~     The aim of this prospective study was to compare the 5-year prognostic value of transient~     elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting~     survival and complications of cirrhosis in patients with chronic liver diseases.~   "
177541|NCT01241214|"~     This study will assess the efficacy and safety of different doses of ACT-129968 in adult~     patients with seasonal allergic rhinitis, due to mountain cedar pollen.~   "
177542|NCT01241201|"~     Rationale: Enterotoxigenic Escherichia coli (ETEC) bacteria adhere to the mucosa of the~     proximal intestines. There it produces an toxin which presents a local and relevant challenge~     to the intestines. This is proposed to give an indication of general resistance and/or the~     local resistance of the intestines. The sequel of events of mucosal inflammation will be~     characterized in this study. In addition we will evaluate the effects of probiotics by~     comparing the infection symptoms and by measuring faecal weight and mucus in faeces.~      Objective: The main objective of this study is to investigate the effect of probiotics on the~     sequels of ETEC administration as intestinal permeability, inflammation and clinical signs as~     total faecal output, relative faecal dry weight and mucin excretion in faeces. In addition,~     the sequels of the mucosal inflammation will be characterized and biomarkers will be~     searched.~   "
177543|NCT01241188|"~     Tuberculosis (TB) continues to be the most important bacterial infection worldwide and~     therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.~      The new skin test is named C-Tb. Like the current Tuberculin Skin Test (TST), the C-Tb test~     is injected just under the skin and will when positive show a redness and/or swelling at the~     injection site while a negative test will leave no reactions.~      The aim of this trial is to test the C-Tb skin test in adults diagnosed with TB to determine~     if a TB infected individual has a truly positive test result (this is called to find the~     sensitivity of the skin test).~   "
177544|NCT01241175|"~     The aim of this study is to assess the effect of preoperatively administered intra venous~     magnesium sulfate in attenuating pressure response to laryngoscopy and endotracheal~     intubation in adult patients scheduled for elective non ocular surgery~   "
177545|NCT01241162|"~     This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic~     sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT)~     antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating~     chemotherapy.~   "
177546|NCT01241149|"~     Gastroesophageal reflux disease (GERD) is a common ailment affecting a significant portion of~     the US population. With the advent and increased use of esophageal impedance monitoring, both~     acid and nonacid reflux disease can be better diagnosed and treated. Patients with severe~     symptoms or symptoms refractory to medical management may be offered anti-reflux surgery for~     optimal treatment. Though there are a handful of studies evaluating the efficacy of~     anti-reflux surgery on those patients with acid or non-acid related reflux disease, the~     comparison between acid and non-acid reflux disease following surgery is lacking. We propose~     a prospective study comparing clinical outcomes from those patients with acid versus non-acid~     reflux disease following anti-reflux surgery with the use of validated and disease specific~     quality of life surveys.~   "
177561|NCT01240954|"~     The purpose of this study is to compare different up-dosing schedules with Osiris.~   "
177562|NCT01240941|"~     This is a phase II Trial of MK-2206 in combination with Endocrine Therapy in patients with~     Hormone Receptor Breast Cancer. After the maximum tolerated dose is determined in the phase~     1b trial (under a separate NCT number), efficacy will be evaluated among 17 patients.~   "
177563|NCT01240928|"~     This is a phase Ib trial that evaluates the safety and tolerability of MK-2206 given in~     combination with exemestane +/- goserelin in pre- and post-menopausal patients with hormone~     receptor-positive metastatic breast cancer.~   "
177594|NCT01240499|"~     The purpose of this study is to measure the effects of a Health-At-Every-Size (HAES) approach~     on global health status of premenopausal overweight women preoccupied about their weight and~     who have been unsuccessful in previous weight loss attempts.~   "
177607|NCT01240330|"~     The objective of this clinical study was to demonstrate the performance of the Vasculaire~     Compression System to increase femoral venous peak velocity (PFV) in healthy subjects. This~     study was a single-arm, open label, prospective, single-center clinical study.~   "
177547|NCT01241136|"~     Pilonidal disease, a chronic infection involving the skin and subcutaneous tissues along the~     sacrococcygeal area (natal cleft) is a common disease affecting mostly young adult males who~     make up the majority of our military workforce. Surgical treatment options for pilonidal~     disease vary widely from the invasive (e.g. wide open excisions) to minimally invasive~     procedures (e.g. removal of lined sinus tracts using minimal excisions) as well as other~     popular treatments involving myocutaneous or skin flaps (Limberg flap and Z-plasty). All of~     these surgical procedures are associated with varying degrees of early and late recurrence~     rates; however, the current, more popular procedure for the treatment of pilonidal disease~     involves wide open excisions.~      A recent advancement in the minimally invasive surgical technique for pilonidal disease~     involves the use of Keyes trephines (a 2-to-9 mm diameter biopsy instrument) to excise the~     individual pits and to drain the cyst cavities. Although this procedure has been proven to be~     effective against pilonidal disease with an overall low early recurrence rate, no clinical~     trial has been performed to rate this procedure of minimal excisions against the current,~     more common procedure of wide open excisions. A recent report has suggested that the~     recurrence rate of pilonidal disease for minimal excisions may be comparable to that of wide~     excisions. Furthermore, reports have also suggested that this minimally invasive procedure~     can be performed with minimal (and possibly local) anesthesia, less post-operative pain~     medication, and may involve a shorter convalescence time for patients.~      In order to compare the early recurrence rates of pilonidal disease and overall patient~     satisfaction between procedures involving minimal and wide open excisions, we propose to~     perform a prospective, randomized clinical trial comparing these two surgical procedures.~     Randomly assigned patients will undergo either 1) wide excisions of all pilonidal-diseased~     tissue (e.g. pits, cavity, sinus tracts), including a surrounding rim of normal tissue and~     left open to heal, or 2) minimal excisions of lined sinus tracts using varying sized~     trephines. Overall patient satisfaction will be evaluated by the amount of analgesic used for~     the procedure, the number of dressing changes, the length of convalescence, and overall~     patient tolerance of the procedures, both intra- and post-operatively. In addition, varying~     data points will be collected with the use of a quality of life survey and visual analog pain~     scale to analyze overall patient satisfaction. Patients will be followed for a period of two~     years following surgery to evaluate for early recurrence of their pilonidal disease.~   "
177548|NCT01241123|"~     Fast-track or enhanced recovery programs, which are the new standardized accelerated~     clinical pathways for post-operative care for colorectal surgeries, have three goals: to 1)~     quicken the return of bowel function (as evidenced by passage of flatus and stool), 2)~     decrease the length of hospital stays, and 3) decrease the rate of overall complications.~     Aside from several components, or interventions that can vary from institution to~     institution, these programs share three common modalities: early oral feeding, protocol pain~     management regimens less dependent on opioid use, and early mobilization (i.e. ambulation).~     Evidence-based practice has shown that the modalities individually contribute significantly~     to the program goals except for post-operative ambulation, which has not been shown to~     increase bowel function although it contributes to decreased pulmonary complications and~     early discharge of patients. Still, surgeons continue to advocate for early ambulation to aid~     in the return of bowel function despite the lack of clear evidence supporting this notion.~      The investigators propose a randomized, prospective clinical trial exploring the impact that~     post-operative ambulation has on the outcome of colorectal surgeries, particularly on the~     return of bowel function and the length of hospital stay. With the use of pedometers to~     measure physical activity, the investigators will subject patients to either the current~     traditional post-operative care or one with an aggressive ambulation regimen. Through the use~     of radiopaque markers, the investigators hope to correlate increased ambulation with~     increased gastrointestinal motility function to prove the impact of early ambulation on~     post-operative care.~   "
177549|NCT01241110|"~     Objective: To compare two oral treatments: Ofloxacin + Metronidazole, and Azitromycin~     +Metronidazole in outpatients with Pelvic Inflammatory Disease.~      Materials and Methods: Two hundred patients divided to two groups( A , B). Group A (treated~     by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine~     1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy~   "
177550|NCT01241097|"~     -  To test the hypothesis that therapy with high dose statin provides endothelial superior~          benefit to the same cholesterol lowering with low-dose statin combined with ezetimibe.~        -  To test the hypothesis that therapy with high dose statin provides anti-inflammatory~          effect than the same reduction of cholesterol with low dose of statin plus ezetimibe~   "
177551|NCT01241084|"~     Objective The aim of the trial is to evaluate the beneficial effects of the oral~     administration of the probiotic L. Reuteri (Reuterin®) on the airways allergic inflammation~     in children with mild to moderate persistent asthma.~      Study design This is a randomized, double-blind, placebo controller trial. 50 children will~     be enrolled (age range 6-14 years), affected by mild to moderate persistent asthma based on~     the GINA Guidelines and allergic to acarus (Dermatophagoides farinae and D. pteronyssinus~     ++/+++). At the enrollment period all children have to show asthmatic symptoms and to be~     under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. Any~     inhaling corticosteroids therapies have to be stopped 8 weeks before the trial beginning.~      Patients will be randomly divided into 2 treatment groups:~      Group A: 25 patients will take antileukotrienes + L. reuteri drops (108 CFU = 5 drops daily).~      Group B: 25 patients will take antileukotrienes + placebo. At the enrollment period (T0),~     after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the~     supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO~     determination and exhale condensate analysis.~      During the entire trial period the number of asthmatic exacerbations and the use of beta-2~     antagonists will be monitored by a diary properly examined at T1, T2 and T3.~      All children will be enrolled at the Asthma and Infant Respiratory Physiopathology unit~     Michele Miraglia del Giudice of the F. Fede Pediatric Department.~      The analysis of the inflammatory markers on the exhaled condensate will be performer at T1,~     T2 and T3 in the Pharmacology unit of the Experimental Medicine Department.~      During the trial it will be possible to administer only salbutamole MDI if it needed. If~     patients will be administered with any systemic corticosteroids they will exit from the~     trial.~      At the enrolment period all patients will receive the completed information on the trial and~     the informed consent will be properly signed.~   "
177552|NCT01241071|"~     The purpose of this study is to determine whether myofascial release techniques are effective~     in the improvement of pain, disability and electromyography response of lumbar muscles in~     patients with chronic low back pain.~   "
177553|NCT01241058|"~     A registry of pediatric patients (under 18 yrs of age) diagnosed with Crohn's disease was~     created in Belgium. Over a 2 year period 257 patients are included. These patients will be~     follow up prospectively during 5 years. Demographic data, family history, disease~     presentation and disease course including medication are registered in CRF's.~   "
177554|NCT01241045|"~     To evaluate the impact of the vaginal Ph and acidification of vaginal misoprostol on its~     efficacy in facilitating induction of midtrimester abortion.~   "
177555|NCT01241032|"~     This study is designed to to investigate the effects of alcohol on the pharmacokinetics of~     Udenafil tablet in healthy male volunteers~   "
177556|NCT01241019|"~     The purpose of this study is to determine whether the administration of topiramate to~     newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of~     treatment with hypothermia.~   "
177557|NCT01241006|"~     This study seeks to compare the effectiveness of a single dose of oral dexamethasone versus 5~     days of oral prednisone in the treatment of mild to moderate asthma exacerbations to prevent~     relapse with an unscheduled return visit to a health care provider for additional asthma~     treatment within 14 days. The investigators hypothesize that the two treatments will be~     equally effective in relapse prevention.~   "
177564|NCT01240915|"~     MultiStem(r) is a new biological product, manufactured from human stem cells obtained from~     adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells~     are believed to reduce inflammation and regulate immune system function, protect damaged or~     injured cells and tissue, promote formation of new blood vessels, and augment tissue repair~     and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of~     Graft versus Host Disease with almost complete reversal of gastrointestinal pathology~     (similar to pathology that would be expected in Ulcerative Colitis). These data, together~     with safety data generated in 2 other clinical trials, suggest that MultiStem has the~     potential to be a new treatment option for patients with ulcerative colitis. This is the~     first study of MultiStem in this patient population and will cautiously explore the~     safety/toleration and potential benefit of this new treatment in patients with moderate to~     severe disease.~   "
177565|NCT01240902|"~     The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve®~     System in the treatment of symptomatic severe aortic stenosis in subjects who have a~     predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.~   "
177566|NCT01240889|"~     This study will be a randomized, double blind, placebo-controlled, parallel group study and~     will include subjects with ragweed-induced seasonal allergic rhinitis.~   "
177567|NCT01240876|"~     The primary objective of the study is to evaluate the safety and efficacy of CEP-37247~     compared with placebo as assessed by the occurrence of adverse events, and the mean change in~     average pain intensity (API) in the affected leg.~   "
177568|NCT01240863|"~     The primary objective of this study is to evaluate efficacy of hydrocodone extended-release~     (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with~     osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at~     week 12.~   "
177569|NCT01240850|"~     Chronic periaortitis is a clinico-pathological entity encompassing idiopathic retroperitoneal~     fibrosis and perianeurysmal retroperitoneal fibrosis. The treatment of this disease is~     generally based on the use of glucocorticoids, which are often effective. However, prolonged~     steroid treatments are usually needed to achieve a sustained remission; additionally,~     patients frequently develop disease relapses following treatment discontinuation, therefore~     they may be exposed to high cumulative doses of glucocorticoids.~      Preliminary data reported in the literature show that methotrexate may be effective in~     combination with prednisone for retroperitoneal fibrosis. In addition, methotrexate is often~     used as a steroid-sparing agent in different inflammatory diseases.~      The aim of this study is to evaluate whether a treatment with low-dose prednisone plus~     methotrexate is non-inferior to conventional dose-prednisone in achieving remission in~     retroperitoneal fibrosis patients.~   "
177570|NCT01240837|"~     The purpose of this study is to determine by how much, the ingestion of palm sugar increases~     blood glucose concentrations and what the corresponding glycaemic index is. The investigators~     estimate that the glycaemic index will be 68 (equal to that of sucrose).~   "
177571|NCT01240824|"~     The purpose of this study is to evaluate whether a new potential treatment for non invasive~     bladder cancer is safe and if it leads to side effects such as irregular heart rate,~     agitation, or burning with urination. Patients who have early stage bladder cancer and will~     be receiving BCG, a bladder cancer therapy as recommended by a doctor, will be asked to~     participate in a study where they are given the standard BCG followed by the experimental~     drug, aminophylline. Although we hope this medicine may one day prove to help bladder cancer~     patients, at the current time we do not know if it has any benefits at all. We have data in~     mice that suggest that aminophylline slows the growth of tumors when coupled with BCG.~   "
177572|NCT01240811|"~     This pilot study is being performed to investigate the influence that starting contraception~     with an IUD has on the local immune cell populations and features, with a particular focus on~     the cells and cell-surface features that are important in HIV transmission (CD4 cells and~     CCR5 cell receptors).~      Based on results from large epidemiologic studies there seems to be a consistent finding of~     slightly increased HIV acquisition in women who use hormonal contraception. It is not clear~     if this is due to a biological phenomenon or if it relates to a difference in sexual~     behaviors/risks of women on hormonal contraceptives.~      The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within~     the upper and lower genital tract of women 2 months after placement of progestin-containing~     intrauterine devices for contraception as compared with women not using hormonal~     contraception.~   "
177573|NCT01240798|"~     People report feeling sad and low (depression) or worried (anxiety) appear more likely to~     subsequently suffer a heart attack, or angina. However it is not known whether depression or~     anxiety actually causes heart disease. If these mental health problems and heart disease were~     cause and effect this has important implications for world health. Previous research on this~     topic has had several limitations. First, most studies have studied heart disease as if it~     were one thing. There is a need for studies which distinguish different types of heart~     disease (e.g. different types of heart attack, angina) which may be linked to mental health~     problems in different ways. Second, it is not clear whether symptoms of heart disease come~     before the depression or anxiety or the other way round? Much of the available research~     cannot look at this in detail because they rely on data from occasional snapshots of study~     populations rather than a continuous record. The investigators propose to use the linkage of~     the national registry of coronary events to general practice records in the GPRD, which will~     allow us to address these limitations. The investigators research will help us understand~     better whether mental health problems cause the onset of different types of coronary disease.~   "
177574|NCT01240785|"~     Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used~     worldwide in the treatment of type 2 diabetes and also in a few studies on patients with~     gestational diabetes. The investigators aim is to compare insulin and metformin in the~     treatment of gestational diabetes. The investigators hypothesis is that there is no~     difference between insulin and metformin treated mothers in the main outcome criteria (birth~     weight, neonatal complications).~   "
177606|NCT01240343|"~     The purpose of this study is to develop a BioBank (a specialized lab) and collect blood,~     fluids and/or other tissue samples to study eye diseases.~   "
177575|NCT01240772|"~     This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease:~     doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according~     to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk and is more~     cost-effective than SH. With a large number of patients managed in more than 20 centres, we~     aim to demonstrate that DGALM has a lower morbidity than SH when treating haemorrhoidal~     disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM would~     demonstrate to be cost-effective for health care system and attractive for patients.~   "
177576|NCT01240759|"~     The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered~     with metformin in subjects with type 2 diabetes mellitus.~   "
177577|NCT01240746|"~     The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the~     licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1),~     and the investigational TIV containing the alternate B (B2) strain in children.~      Primary Objective:~      To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011~     TIV (containing the primary B strain) and investigational TIV (containing the alternate B~     strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains~     separately among children aged 6 months to less than 9 years of age~      Secondary Objective:~      To demonstrate superiority of antibody responses to each B strain in QIV compared with~     antibody titers following vaccination with the TIV that does not contain the corresponding B~     strain, as assessed by GMT ratios and seroconversion rates.~      Observational Objective:~      To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as~     assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days~     post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and~     adverse events of special interest and serious adverse events (SAEs) collected from Visit 1~     to Visit 2.~   "
177578|NCT01240720|"~     The aim of this Study Protocol is to provide a basis for the clinical development of~     131I-F16SIP as an anti-cancer therapeutic agent.~      The study follows and is greatly motivated by the promising results of a Phase I/II study~     with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian~     centers.~   "
177579|NCT01240707|"~     Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and~     impaired gas exchange. In this study the investigators will examine if the scope of~     inhalation injury can be assessed soon after hospital admission based on clinical markers,~     biochemical markers, Peak Expiratory Flow (PEF), spirometry and bronchoscopy. At 6 months a~     lung function test and metacholine test will be performed to examine whether patients have~     developed increased bronchial hyperreactivity (asthma) or not after the initial fire smoke~     exposure.~   "
177580|NCT01240694|"~     The primary objective of this study is to evaluate the long term safety and tolerability of~     repeated administration of subcutaneous (sc) CEP 33457 for injection every 4 weeks over 72~     weeks (18 doses) in patients with systemic lupus erythematosus (SLE) who have participated in~     a previous Cephalon sponsored clinical study of CEP 33457, and completed at least visit 8~     (week 24 of that study).~   "
177581|NCT01240681|"~     The objective of this pilot study is to determine the effectiveness of Fluorothymidine~     Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance~     Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women~     with locally advanced breast cancer.~   "
177582|NCT01240668|"~     The registry is a multi-center, prospective, observational study designed to collect data in~     patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and~     hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in~     Europe; patients with hypovolemic hyponatremia will be excluded from the registry. The~     registry is observational in design, and the registry will collect data on patients with a~     serum sodium ≤130 mmol/L. Data from the patients' chart will be collected throughout the~     duration of the hospital, from admission to discharge, and the data will be entered into the~     case report form (CRF) or into an electronic data capture (EDC) system. These patients will~     be entered into the registry over the duration of 18 months at community, tertiary, and~     academic medical centers from diverse multiple regions of the USA and Europe.~      A patient's treatment will be determined by their caregiver and not by this protocol. Thus,~     the registry will provide a unique opportunity to evaluate how the patients are managed under~     real-world management conditions.~   "
177583|NCT01240655|"~     This is a dose escalation study that will assess the safety and efficacy of LCL161 in~     combination with weekly paclitaxel in adult patients with advanced solid tumors.~   "
177584|NCT01240642|"~     The purpose of this study is to determine the effect of the ASA404 infusion rate and~     co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on~     the pharamcokinetics (PK) of free and total ASA404.~   "
177585|NCT01240629|"~     This is a research study for advanced prostate cancer. An experimental drug called AN-152~     (also known as AEZS-108) will be used. The purpose of this study is to test the safety,~     tolerability and benefits of an experimental drug called AN-152.~      The participants tumor will be tested for expression of this receptor (using an old biopsy).~     If the participants cancer does not have this receptor, participants will not be eligible to~     participant in this study.~      AN-152 (AEZS-108) is administered intravenously (IV) over 2 hours and will be given at the~     specified dose every 3 weeks. Premedication with dexamethasone 8mg is recommended.~      Participants will continue treatment until death, disease progression, unacceptable toxicity,~     participants refusal, treatment delay >3 weeks, or the completion of 6 cycles. Continuation~     beyond 6 cycles is left at the discretion of the study doctor.~      The study is planned to last 2 years. Up to 55 (up to 18 for the Phase I portion, up to 37~     for the Phase II portion).~   "
177593|NCT01240512|"~     This is a randomized, double-blind, multicenter, 6-month follow-up trial of low (400 IU/day)~     versus high (4000 IU/day) dose vitamin D supplementation in individuals with pre- and early~     stage 1 hypertension and vitamin D deficiency. A total of 530 participants (265 participants~     per treatment arm) will be randomized between 3 sites. Approximately 2,250 participants will~     be screened between the 3 sites. Vital signs, 24-hour ambulatory blood pressure monitoring,~     clinical laboratory safety tests and adverse event assessments will be performed to evaluate~     the effectiveness of the two doses of vitamin D on blood pressure. Blood samples will be~     stored for future biomarker assessments. The total duration of the study is anticipated to be~     18 months, assuming a 12 month enrollment period.~   "
177586|NCT01240616|"~     Background:~      - A brain circuit called the default network is the brain circuit that is active when the~     brain is at rest; that is, when individuals are not concentrating on specific tasks. Previous~     research has shown that the default network functions differently in people with~     schizophrenia and Alzheimer s disease, and may contribute to the problems with memory and~     concentration that can affect people who have these conditions. Studies have also shown that~     nicotine affects the default network, but more research is needed on the ways in which~     nicotinic receptors may change activity in these regions and thereby affect individuals~     ability to concentrate on specific tasks.~      Objectives:~      - To determine whether and how nicotine and mecamylamine, a drug that blocks nicotinic~     receptors, affect the default network in nonsmokers in ways that improve thinking and~     concentration.~      Eligibility:~        -  Healthy, right-handed volunteers between 21 and 50 years of age.~        -  Volunteers must not have used any kind of tobacco product in the past 2 years.~      Design:~        -  This study involves an initial screening visit, a training visit, and three testing~          visits.~        -  Participants will be screened with a medical history and physical examination, as well~          as blood and urine samples and questions about smoking history.~        -  Participants will have an initial training session to practice the tasks that will be~          done during magnetic resonance imaging scans at the testing visits. These tasks will~          test participants concentration and memory.~        -  Participants will have three test sessions with the following combinations of study~          drugs: (1) a nicotine patch and a placebo capsule, (2) a placebo patch and a capsule of~          mecamylamine, or (3) a placebo patch and capsule. Different combinations will be given~          at each visit, and participants will not know which one they receive.~        -  Participants will perform the same concentration and memory tasks at each testing visit,~          and will provide a blood sample after each visit to determine levels of nicotine and~          mecamylamine.~   "
177587|NCT01240603|"~     Plasmodium falciparum parasite clearance rates (PCRs) after oral artesunate treatment of~     patients with uncomplicated malaria were recently found to be significantly slower in Pailin~     (Western Cambodia) compared to Wang Pha (Eastern Thailand). This difference in PCRs has been~     attributed to different histories of artesunate drug pressure in the two areas. In Pailin,~     artesunate monotherapy has been used inappropriately for 30 years and is hypothesized to have~     selected for artemisinin-resistant parasites (slow PCRs). To investigate the potential~     contribution of human factors to the artemisinin resistance phenotype, we have identified a~     study site in Eastern Cambodia where artemisinin-resistant parasites are not believed to be~     present. The main aims of this study are to 1) determine whether the artemisinin resistance~     phenotype (i.e., a half-life longer than the 2-hour half-life observed in Wang Pha) is~     present in Eastern Cambodia, 2) determine whether hemoglobin E affects parasite clearance~     rates in vivo, 3) determine whether age-associated acquired immunity affects parasite~     clearance rates in vivo, and 4) identify parasite-heritable traits that are associated with~     slow parasite clearance rates in vivo. To meet these aims, we are conducting a prospective,~     longitudinal study to recruit Cambodian residents of Lumphat District in Ratanakiri Province~     who complain of fever and/or symptoms of malaria. Patients diagnosed with uncomplicated~     malaria will be treated with weight-based doses of artesunate given orally each day for 3~     days followed by mefloquine given orally for 2 days. During this time, finger prick blood~     smears will be obtained every 6 hours until parasite density is zero. From these data, we~     will estimate parasite clearance rates using a half-life parameter. We will also collect~     parasitized red blood cell samples from malaria patients prior to antimalarial drug~     administration. These parasites will be tested in short-term in vitro culture experiments to~     determine their susceptibility to artemisinins and other antimalarial drugs.~   "
177588|NCT01240590|"~     Background:~      Anaplastic thyroid cancer (ATC) is one of the most aggressive of all solid tumors;~     chemotherapy and surgery have had no impact on local control or survival of patients, with a~     median survival of 3-7 months.~      Crolibulin (EPC2407) is a microtubulin inhibitor that has been shown to have direct antitumor~     effects in vivo and in vitro, destabilizing spindles and inducing apoptosis, resulting in the~     disruption of neovascular endothelial cells with disruption of blood flow to the tumor. Early~     clinical studies with combretastatin, from which crolibulin is derived, demonstrated efficacy~     in a subset of patients with ATC.~      Objectives:~      The primary objective in the Phase I portion is to assess the safety and tolerability of~     cisplatin and crolibulin given in a 21-day cycle in dose-seeking cohorts.~      We will assess the toxicities of crolibulin coadministered with cisplatin, evaluate~     dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) for the~     combination.~      The primary objective in the Phase II portion is to compare the combination crolibulin plus~     cisplatin versus cisplatin alone in adults with ATC by assessing the duration of~     progression-free survival (PFS); comparison of the response rates as evaluated by Response~     Evaluation Criteria in Solid Tumors (RECIST) will be an important secondary objective.~      We plan on biochemical and immunohistochemical analysis of several tumor parameters including~     mitotic index, expression of several proteins including epidermal growth factor receptor~     (EGFR), vascular endothelial growth factor receptor (VEGFR), BRAF, excision repair~     cross-complementation group 1 (ERCC1) and tumor protein p53 (TP53). Where sufficient tissue~     is available we will also perform gene expression analysis, micro ribonucleic acid (microRNA)~     array analysis, and compare these with 3-deoxy-3 -[(18)F] fluorothymidine (FLT)-positron~     emission tomography (PET) and tumor growth rate constant.~      Eligibility:~      Phase I: adults age 18 and older with unresectable, recurrent or metastatic solid tumors.~      Phase II: adults age 18 and older with anaplastic thyroid cancer.~      In the phase II portion disease must be evaluable by RECIST.~      All patients must have adequate hepatic, renal, and bone marrow function.~      Design:~      The Phase I component consists of dose-escalation cohorts of three to six patients, in which~     all patients receive both the study drug crolibulin with cisplatin. The MTD and DLT will be~     determined based on toxicities during the first three weeks of combined therapy.~      The Phase II component will be a randomization study, to either crolibulin with cisplatin or~     cisplatin monotherapy. Patients randomized to cisplatin alone will have the opportunity the~     opportunity to cross over to the crolibulin arm in the event of tumor progression.~      Drug administration will take place on days 1, 2, and 3 for crolibulin, and on day 1 for~     cisplatin, on a 21-day cycle.~      Maximum number of patients for planned enrollment is 70. During the Phase I portion of the~     study, dose-seeking cohorts of three to six patients will be enrolled until MTD / DLT is~     reached for a maximum of three dose cohorts [up to 24 patients if one assumes an expansion~     cohort to twelve patients at the recommended phase 2 (RP2) dose]. During the randomized Phase~     II trial comparing the activity of the combination of crolibulin plus cisplatin with~     cisplatin alone it is estimated that a maximum of 40 patients will be enrolled [1:1~     randomization 20 + 20 = 40 patients], and we will allow for 6 extra patients to be enrolled~     to compensate for a small number of non-evaluable patients.~   "
177589|NCT01240577|"~     Background:~      - The experimental drug IPdR is broken down in the body to IdUrd, which has been given to~     patients to find out if it can improve radiation therapy. IdUrd has to be given through a~     vein; therefore this new drug (IPdR) has been made which can be taken by mouth. Researchers~     are interested in determining whether IPdR should also be studied to find out if it can~     improve radiation therapy. The current study is to find out if people absorb the drug given~     by mouth.~      Objectives:~      - To evaluate the levels of drug and its breakdown products in the blood following a single~     dose of IPdR by mouth. .~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with cancer (solid tumors or~     lymphomas) that have not responded to standard treatment.~      Design:~        -  This study involves an initial dosing visit, one day of admission to the hospital for~          blood work, and a follow-up visit 14 days later.~        -  Participants will be screened with a physical examination and medical history, as well~          as blood and urine samples.~        -  Participants will receive a single dose of IPdR, and will provide multiple blood and~          urine samples for 24 hours after administration of the drug.~        -  Fourteen days after receiving IPdR, participants will have another physical examination~          and additional blood and urine tests to evaluate how IPdR has been broken down by the~          body.~        -  Cancer treatment will not be provided as part of this protocol.~   "
177590|NCT01240551|"~     Background:~      - Sodium fluoride (NaF) is a common compound that is found in various foods and can be used~     to increase bone strength. When this compound is added to a small dose of radiation (F-18),~     it collects in the bones, with higher amounts in areas where the bone is rapidly changing,~     such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined~     positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able~     to better measure the changes in the bone that may indicate that a certain type of cancer~     (such as prostate cancer) has spread to the bones.~      Objectives:~        -  To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and~          their change over time and compare with clinical course, in individuals with prostate~          cancer.~        -  To determine the smallest amount of change in the bone tumors that F-18 NaF can~          accurately measure.~      Eligibility:~      - Men at least 18 years of age who have been diagnosed with prostate cancer and have had~     imaging studies to determine whether the cancer has spread to their bones. Both patients with~     and without known bone involvement will be enrolled.~      Design:~        -  Participants will be screened with a physical examination, medical history, and imaging~          studies, and will provide baseline blood samples to evaluate kidney function.~        -  For the study, participants will have two F-18 NaF PET/CT scans on separate days for~          baseline. These repeat scans will be used to determine the amount of change that is due~          to the imaging process alone (i.e. not due to the disease getting better or worse.~          Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT~          scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a~          complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection.~          Participants will be watched closely for side effects from the F-18 NaF until the scans~          are done, and will be asked to drink plenty of water to void the F-18 NaF from the body~          after the scans.~        -  As a followup study, participants will have two more F-18 NaF PET/CT scans, one 4 to 8~          months after the first scans and then one 10 to 14 months after the first scans.~          Participants will provide additional blood samples before the followup scans.~   "
177591|NCT01240538|"~     This phase I trial studies the side effects and the best dose of viral therapy in treating~     young patients with solid tumors that have come back or that have not responded to standard~     therapy. Some tumors have cells with a genetic weakness that makes them unable to fight off a~     virus called wild-type reovirus. The virus causes cells with this weakness to die, and may~     therefore be able to kill tumor cells without damaging normal cells. Cyclophosphamide is a~     drug used in chemotherapy that stops tumor cells from dividing and causes them to die. Giving~     wild-type reovirus together with cyclophosphamide may kill more tumor cells.~   "
177592|NCT01240525|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a~     donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's~     immune system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) that have been~     treated in the laboratory after the transplant may help increase this effect. Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving alemtuzumab before transplant and cyclosporine after transplant, may stop this~     from happening.~      PURPOSE: This randomized phase II trial is studying donor lymphocyte infusion after stem cell~     transplant in preventing cancer relapse or cancer progression in patients with follicular~     lymphoma, small lymphocytic non-Hodgkin lymphoma, or chronic lymphocytic leukemia.~   "
177595|NCT01240486|"~     Your child is able to participate in this study, if your child's doctor is planning to start~     your child on HAART (which is a combination of at least 3 anti HIV drugs). When your child is~     treated with HAART, the way your child's body is able to fight infection may change. The~     immune system is the body's defense against infection. Your child's immune system may respond~     in a stronger way to some types of infections that your child may already have. This immune~     response may cause your child to become sick and the condition is then called immune~     reconstitution inflammatory syndrome or IRIS.~   "
177596|NCT01240473|"~     Kala azar (KA) or visceral leishmaniasis (VL) is endemic in several districts of Bangladesh~     with the highest incidence in Mymensingh, Pabna and Tangail districts. ICDDR,B is involved in~     a project for improving the surveillance of KA in Trishal, Mymensingh since 2005. Improvement~     of case detection is necessary for both surveillance purposes and better control. The aims of~     this pilot study are to assess some newer techniques for diagnosis of KA using blood and~     urine samples of suspected cases; and evaluate response to treatment with sodium~     stibogluconate to which resistance has been reported in India, considered to be a part of the~     same zone harboring the disease agent Leishmania donovani and transmitted by the same vector~     Phlebotomas argentipes (sand-fly). No data is currently available on response to sodium~     stibogluconate in KA patients in Bangladesh. Although a number of new drugs have been~     evaluated in the treatment of KA in India and Kenya, no trial has so far been conducted in~     Bangladesh. A team of researchers from GlaxoSmithKline (UK) had recently visited Bangladesh~     to evaluate if it would be possible to conduct a Phase-III clinical trial with sitamaquine.~     They interacted with scientists of ICDDR,B and expressed their interest to help develop~     ICDDR,B's capacity in order to include Bangladesh as one of the sites for the planned,~     multi-centre, Phase-III trial of sitamaquine; India and Nepal are two other possible sites~     for the trial. The aims of the proposed study are to train physicians and laboratory~     personnel in preparation for the future drug trial(s) on KA as well as to compare different~     tests for its diagnosis that might improve case detection at the field level and used for~     research purposes. The investigators will also examine in greater detail the different~     Leishmania species circulating in the area of Mymensingh and whether treatment failure and~     occurrence of Post Kala azar Dermal Leishmaniasis (PKDL) is associated with certain species.~   "
177597|NCT01240460|"~     The purpose of this study is to measure what effect the study drug XL765 (SAR245409) or the~     study drug XL147 (SAR245408) has on tumor tissue in subjects with recurrent glioblastoma (GB)~     who are candidates for surgical resection. XL765 (SAR245409) and XL147 (SAR245408), the two~     investigational agents examined in this study, XL147 (SAR245408) is a potent inhibitor of PI3~     Kinase (PI3K) and XL765 (SAR245409) is a dual PI3K and mTOR inhibitor. In preclinical~     studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis~     (programmed cell death) in tumor cells.~   "
177598|NCT01240447|"~     This study is designed to evaluate safety and immunogenicity of racotumomab in patients with~     advanced Non-small Cell Lung Cancer (NSCLC), in concomitance with chemotherapy (docetaxel)~     when a second-line therapy is indicated. The study will also compare survival and progression~     free survival on both study arms.~   "
177599|NCT01240434|"~     The investigators perform a simple-blind randomized trial with two groups, one in which all~     the orifices are closed by suturing the external fascia of the abdominal wall (Group A), and~     another in which the orifices are left open, closing only the skin (Group B). Monitoring for~     trocar site hernia lasted 2 years from the intervention.~   "
177600|NCT01240421|"~     This expanded access program is an open-label, multi-center study, which will consist of a~     PreTreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast~     cancer who fulfill the eligibility criteria will be treated. The program will continue in~     each country until eribulin is approved, reimbursed and launched in that country, or~     termination of the program by the Sponsor.~   "
177601|NCT01240408|"~     This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy~     subjects. The study will consist of two phases: Pre-randomization and Randomization. The~     Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization~     Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted and~     fasted/fed). In each period, subjects will receive a single capsule containing 10 mg~     lenvatinib either with or without a standard breakfast. There will be a 2-week washout~     between treatments.~   "
177602|NCT01240395|"~     The objective of this study is to evaluate the effect of mindfulness-based cognitive therapy~     (MBCT) on physical symptoms attributed to chemical exposures, psychological distress, illness~     worry, quality of life, and illness perceptions in patients suffering from multiple chemical~     sensitivity (MCS). Furthermore, a secondary objective is to evaluate whether a possible~     symptom reduction is mediated by an increased level of mindfulness.~      The primary hypothesis is that the self-reported severity of MCS symptoms and the degree to~     which chemical exposures causes symptoms and the impact on daily life will be significantly~     improved in the MBCT treatment group as compared to the control group.~   "
177603|NCT01240382|"~     To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6~     times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate~     ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical~     administration), is at least non-inferior in the change in fluorescein staining score, and is~     superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group~     comparison study. Safety profile will likewise be compared.~   "
177604|NCT01240369|"~     Lung cancer and esophageal cancer remain the leading causes of cancer death worldwide. The~     main problem is lack of effective tool in early detection that accounts for the poor outcome~     of cancer. Clinically, over 80% of patients with cancer were at late stage when they were~     diagnosed. Therefore, it is important for us to find the biomarker that serve as the early~     prediction of cancer.~      The investigators have published that VEGFC over-expressed in non-small cell lung cancer.~     VEGFC plays a critical role in regulating motility of tumor cells, promotes proliferation of~     lymphatic endothelial cells and enhances migration and invasion. Investigator found that~     VEGFC over-expressed in the serum of esophageal cancer patients. Therefore, it is worthwhile~     to investigate the correlation between VEGFC, clinical lung cancer and esophageal cancer.~      MicroRNAs (miRNAs) are conserved, endogenous, small, and noncoding RNA molecules of 21~23~     nucleotides that function as post-transcriptional gene regulators. Recent studies indicated~     that certain microRNAs reduced in cancer patients. Therefore it is important to investigate~     whether specific microRNA changed in certain kinds of cancer patients.~   "
177605|NCT01240356|"~     The purpose of CLOTBUST-HF is to determine the safety of a novel, external Hands-Free~     transcranial Doppler (TCD) ultrasound system in healthy volunteers and ischemic stroke~     patients. If found to be safe, the widespread use of operator-independent,~     ultrasound-enhanced thrombolysis will allow the planning for a large Phase III efficacy~     trial.~   "
177608|NCT01240317|"~     In this study, the investigators are testing the expert system called eVENT. eVENT provides~     expert advice about the patient's breathing. The investigators have developed and tested a~     prototype of eVENT and now want to test how it works in practice. To do this the~     investigators plan to use computer based simulations and test it when used by~     anesthesiologists in a full size human simulator. If these tests are successful the~     investigators will then be ready to evaluate eVENT on real patients.~   "
177609|NCT01240304|"~     The purpose of this phase II clinical trial study is to assess the resection rate among~     subjects who have been initially diagnosed with unresectable or borderline resectable~     pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will~     include alternating cycles of chemotherapy and radiotherapy treatment. In addition, this~     clinical trial will assess the safety of preoperative chemotherapy with radiation therapy for~     subjects with unresectable or borderline resectable adenocarcinoma of the pancreatic head,~     assess margin-negative resection rates, disease-free survival, assess overall survival rates,~     and determine patterns of local and distant recurrence.~   "
177610|NCT01240291|"~     The purpose of this trial is to investigate if pharmacologically safe dose intravenous~     glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition~     is associated with improved clinical outcomes in terms of decreased organ dysfunction,~     infectious complications, and other secondary outcomes~   "
177611|NCT01240278|"~     Increased mammographic density is recognized as an important risk factor for developing~     breast cancer, however, the underlying mechanism explaining this relationship is unclear. The~     investigators hypothesize that Molecular Breast Imaging (MBI) can more accurately distinguish~     dense tissue on mammography which is at high risk from dense tissue at low risk by indicating~     cellular activity in dense tissue as radiotracer uptake (functional density) in the breast.~     In this pilot study, the investigators want to compare the histological characteristics of~     breast tissue in patients with who have similar density on mammography but different levels~     of functional density on MBI.~   "
177612|NCT01240265|"~     Adequate vitamin D is essential for proper infant growth and development. However, human milk~     is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is~     to assess the feasibility of providing adequate vitamin D to breastfed infants through~     maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of~     age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized~     to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single~     dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium;~     maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the~     study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.~   "
177613|NCT01240252|"~     The study is being conducted to find out why too much fat in your blood stream may cause~     insulin resistance in your muscles. Insulin is the hormone, produced normally by your body,~     which causes your blood sugar to return to normal after you eat.~   "
177614|NCT01240239|"~     The purpose of the study is to evaluate different methods of pre-anesthesia consultation,~     with the aim of improving the day of surgery experience for the patient. In this study, we~     will use a telephone consultation, an in-person consultation, and a telemedicine~     consultation, which involves television cameras and monitors that allow live two-way~     communication for the pre-anesthesia consultation. The reason for this study is to evaluate~     the use of telemedicine for the pre-anesthesia consultation. Patients and anesthesiologists~     have been highly satisfied in previous studies using pre-anesthesia telemedicine~     consultation. In this study, we will examine a larger group of patients, as previous studies~     have studied smaller groups of patients.~   "
177615|NCT01240226|"~     This will be a single-center, open-label, randomized, 2-part study to determine the relative~     bioavailability of GDC-0941 capsule and market-image tablet formulations and the effect of~     ketoconazole on the pharmacokinetics of the GDC-0941 market-image tablet formulation.~   "
177616|NCT01240213|"~     Experimental and human data suggests that vitamin D could protect against breast cancer.~     Overweight/obese individuals are at increased risk of low vitamin D levels. Vitamin D may~     reduce production of fat tissue, thereby reducing weight gain, which would result in lower~     levels of adipose-derived hormones and other breast cancer risk factors.The purpose of this~     study is to test the effect of vitamin D supplementation on the response to a weight loss~     (diet + exercise) intervention and select breast cancer risk factors in overweight and obese~     postmenopausal women with low blood vitamin D levels.~   "
177617|NCT01240200|"~     Several studies have shown that high blood sugar (glucose) levels are associated with~     diseases caused by the diabetes. Controlling the glucose may prevent these complications. As~     people age, their bodies become unable to make enough insulin to control the blood sugars.~     Pills used to treat diabetes may help for a while, but many times this does not last. When~     the blood sugar is too high, insulin is frequently recommended and used to treat diabetes.~     Insulin is often started by adding a long-acting insulin to the medicines a patient already~     takes. In this study, glargine insulin will be taken together with the diabetes pills~     currently being used. Glargine is a long-acting insulin which is given under the skin once a~     day. Glargine is approved for use in the treatment of patients with diabetes by the FDA (Food~     and Drug Administration).~      Currently, insulin delivery is only available as a shot. The purpose of this study is to~     compare how satisfied patients are when using two different types of insulin shots.~     Specifically, this study aims to determine if people over 65 years old are more satisfied~     taking insulin shots by pens or syringes. Everyone who joins in this study will have a chance~     to use the insulin syringes and the insulin pens.~      The ability of patients to give themselves shots can affect how well the sugar is controlled.~     As people age, medical and other problems may develop that affect their ability to do certain~     things. Another aim of this study is to determine if the ability to use an insulin pen and~     insulin syringe is affected by age or some other problem.~      During this 25 week long study, patients will be treated with insulin given by a syringe for~     12 weeks and by a pen for 12 weeks. Questionnaires will be given to determine satisfaction~     with treatment throughout the study. The investigators hypothesize that among elderly~     patients with type 2 diabetes mellitus failing oral agent therapy, treatment with basal~     insulin via a pen device results in higher treatment satisfaction scores and more accurate~     dosing than treatment with basal insulin via conventional vial/syringe methods.~      A total of 56 subjects with type 2 diabetes will be recruited into this study. The site for~     the study is Grady Memorial Hospital clinics.~   "
177618|NCT01240187|"~     The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and~     one 12 mg tablet of perampanel in healthy subjects.~   "
177634|NCT01239979|"~     The investigators sought to assess whether plasma myeloperoxidase (MPO) levels differ among~     patients with stable and unstable CAD patients and control subjects, and correlate with~     inflammatory and clinical risk factors such as ox-LDL, NO,leptin, adiponectin, sPLA2,~     Lp-PLA2, homocysteine and 3-nitrotyrosine in the patients.~   "
182412|NCT01177189|"~     The purpose of this study is to understand why and how oxidative stress negatively impacts~     mobility in the elderly, and to determine whether antioxidant supplements can increase~     vascular health and mobility.~   "
177619|NCT01240174|"~     Studies show, guidelines state, and performance measures assert that antibiotic prescribing~     for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe~     antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States~     each year. Previous successful interventions have only reduced the antimicrobial prescribing~     rate to 40% or 50%. It is unknown if the antimicrobial prescribing rate for acute bronchitis~     can be brought to near zero percent in actual practice while maintaining patient safety and~     satisfaction. The goal of this study is to develop an Electronic Health Record~     (EHR)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis~     with a goal of reducing the antibiotic prescribing rate to near zero percent.~   "
177620|NCT01240161|"~     The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue)~     biomarkers will better predict early brain tumor response to treatments and will be more~     reliable prognostic markers in patients with malignant brain tumors.~   "
177621|NCT01240148|"~     The purpose of this study is to investigate the effect of AZD3161 on mechanical pain~     sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin.~   "
177622|NCT01240135|"~     The purpose of this study is to evaluate the clinical performance of a silicone hydrogel~     contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).~   "
177623|NCT01240122|"~     An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS~     at specific time points over the course of four days. The study was conducted with PureVision~     lenses.~   "
177624|NCT01240109|"~     The objective of this study was to compare the effect of remifentanil on suppression cough~     reflex during emergence in patient anesthetized using either propofol or sevoflurane~     additionally under infusion of the identical concentration of remifentanil.~   "
177625|NCT01240096|"~     Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo,~     followed by 8 weeks of open-label mirtazapine 15 mg daily~   "
177626|NCT01240083|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of~     the frontal cortex are used to modulate the neuronal excitability in patients with~     depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst~     Stimulation of the DLPFC is more effective in patients with a depressive episode.~   "
177627|NCT01240070|"~     Despite several clinical trials have clearly demonstrated that the correction of a single~     cardiovascular risk factor in patients with type 2 diabetes decreases the incidence of~     myocardial infarction and other cardiovascular disease (CVD) events, only the Steno study has~     been evaluating the effect of a multifactorial intervention strategy on macrovascular~     complications of diabetes. For this reason, the disease management approach currently~     endorsed by international guidelines (i.e correction of all major CVD risk factors to target~     levels usually lower than lower risk populations) has not been extensively investigated in~     terms of prevalence of application in current clinical practice and in terms of real~     efficacy.~      The Multifactorial INtervention in type 2 Diabetes - ITaly (MIND.IT) is a multicentric~     two-phase study involving 9 Diabetes Care Units throughout Italy with the overall aims of:~     (1) investigating the degree of application of the international guidelines for CVD~     prevention in type 2 diabetic patients and (2) verifying whether the application of an~     intensive multi-factorial intervention inspired by these guidelines is feasible and effective~     in decreasing the incidence of new CVD events.~   "
177628|NCT01240057|"~     This trial investigates whether prenatal intervention improves survival rate of fetuses with~     isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to~     expectant management during pregnancy, both followed by standardized postnatal care.~   "
177629|NCT01240044|"~     This study intend to assess the pain intensity of newborns in neonatal intensive care unit~     (NICU) undergoing different techniques of respiratory therapy and compare these procedures. A~     randomized controlled clinical trial and blind trial with newborns admitted to NICU. The~     babies were categorized according to gestational age , age, weight, diagnosis, support and~     signs of respiratory distress. Then, they were allocated by lot to come from one of 3 groups:~     G1 - control, G2 - undergoing physical therapy; G3 - received the thoracoabdominal~     rebalancing. Each newborn received just one physical therapy session in that they were~     assessed before one of the three procedures (T1), immediately after (T2) and after 15 minutes~     (T3). This evaluation found cardiorespiratory parameters (oxygen saturation, heart and~     respiratory rate) and three specific scales for pain assessment (NIPS, NFCS and PIPP). The~     hypothesis is that newborns hospitalized in intensive care unit did not show pain when~     undergoing respiratory therapy.~   "
177630|NCT01240031|"~     The purpose of this study is to determine whether individualised nutritional therapy~     comprised of appetising, energy- and protein-rich foods can have a positive effect on~     physiological function and quality of life of undernourished patients as compared to usual~     nutrition care.~   "
177631|NCT01240018|"~     The aim of the ProSat study is to examine the effects of a probiotic capsule containing Lb.~     Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone~     response in a single meal test and to determine whether the acute effects persist after daily~     supplementation of the probiotic capsule.~   "
177632|NCT01240005|"~     30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the~     time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several~     studies have been initiated to find alternative therapeutic options.~      Cytokine induced killer cells(CIK) are an unique population of cytotoxic T lymphocytes with a~     characteristic CD3+ CD56+ phenotype; they can be generated from cytokine cocktail-induced~     peripheral blood mononuclear cells (PBMC). CIK cells represent strong anti-tumor cytotoxicity~     in vitro and in vivo. Interestingly,the anti-tumor activity of CIK cells can be enhanced by~     incubation with dendritic cells (DC), which are the most potent antigen (Ag)-presenting~     cells.~      The purpose of this study was to evaluate the clinical efficacy of DC-activated CIK cell~     treatment following regular therapy and the effects of this therapy on immune responses in~     patients with renal cell carcinoma after surgery.~   "
177633|NCT01239992|"~     The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial~     lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and~     postprandial biomarkers of endothelial dysfunction and inflammation.~   "
177660|NCT01239641|"~     The purpose of this study is to determine whether HIFU has superiority over traditional~     surgery on satisfaction and adverse impact.~   "
177635|NCT01239966|"~     In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical~     ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold~     standard for supportive care. However, despite a relative low tidal volume, approximatively~     one third of patients will experienced tidal hyperinflation, a phenomenon known to induce~     pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4~     ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia~     and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra~     corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.~      Patients with ARDS also frequently develop acute renal failure which may required Renal~     Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.~      The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of~     patients presenting ARDS and acute renal failure will allow the tidal volume to be further~     reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.~      For this purpose, the investigators sought to evaluate the safety and efficacy of adding a~     membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the~     hemofilter.~   "
177636|NCT01239953|"~     Treatment of patients with bare metal stent restenosis remains a challenge. This study will~     assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent)~     is superior in the treatment of patients suffering from bare metal stent restenosis.~   "
177637|NCT01239940|"~     Treatment of patients with drug-eluting stent restenosis remains a challenge. This study will~     assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent)~     is superior in the treatment of patients suffering from drug-eluting stent restenosis.~   "
177638|NCT01239927|"~     This prospective randomized trial is to prove the equivalence of primary sigmoid resection~     with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis~     with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with~     peritonitis caused by perforated left-sided colon diverticulitis.~   "
177639|NCT01239914|"~     COACT registry is a multicenter registry of consecutive patients undergoing coronary stent~     implantation at 8 centers in the Catholic University of Korea to evaluate the real world~     management of patients with coronary artery disease and to assess their in-hospital, medium~     and long-term outcomes.~   "
177640|NCT01239901|"~     The purpose of this research study is to determine the frequency and severity of iron~     overload in patients with Sickle Cell Anemia and its relationship to blood vessel function.~     The investigators hypothesize that intermittent transfusions that these patients receive~     during hospitalizations produces significant iron overload and impairs blood vessel~     relaxation.~   "
177641|NCT01239888|"~     The purpose of this study is to determine whether an oxytocin ad-on, or oxytocin and tibolone~     ad-on can induce a response to antidepressants in patients with treatment resistant~     depression.~   "
177642|NCT01239875|"~     RATIONALE: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells and~     white blood cells may help the body build an effective immune response to kill tumor cells.~     Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with~     cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine~     therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's~     lymphoma.~   "
177643|NCT01239862|"~     The aim of this study was to analyze the safety, pulmonary function, and quality of life data~     of patients with silicosis treated with intrabronchial instillation of bone marrow derived~     mononuclear cells (BMDMC, 2x107) through bronchoscopy.~   "
177644|NCT01239849|"~     Because Diabetes Mellitus is one of the major risk factors for CV disease and lots of related~     evidences have been published including CARDS study that showed definite benefit of statin~     treatment in DM patients and influenced ADA guideline. & NCEP ATP III update. However, there~     are large unmet medical needs for DM patients who don't reach their target LDL-C level~     defined NCEPT ATP III update because of physicians usually start with the lowest dose of~     statin and then titrate to the goal. Thus, we are curious about changing our prescription~     pattern into more tailored way; selecting starting dose based on the individual risk factors~     and concomitant status will impact the goal achieving rate for DM patients. Besides that, we~     are going to find out preliminary data about other markers change; small dense LDL and~     adiponectine;. Small dense LDL-C is more inflammatory and atherogenic LDL-C that may explain~     the impact of triglyceride. Adiponectin is another good marker related with obesity and~     metabolic syndrome.~   "
177645|NCT01239836|"~     Urinary incontinence is a common and bothersome condition that remains frequently untreated~     among senior women. The aim of this trial is to compare the effectiveness of two~     community-based continence promotion interventions aimed at improving rates of self-care~     and/or professional health-care seeking in older women with urinary incontinence. The main~     hypothesis posits that participation in a constructivist interactive workshop combined with~     use of an evidence-based self-management tool will yield rates of improvement in incontinence~     frequency and reduce the cost of pad use by 20% compared to either intervention alone, which~     individually are expected to yield minimal effect sizes of at least 0.3 compared to a sham~     intervention.~   "
177646|NCT01239823|"~     The purpose of this randomized, controlled trial is to determine whether a vibration platform~     exercise program will be more effective than a standard platform exercise program in~     improving quadriceps strength in women age 45-60 who have risk factors for knee~     osteoarthritis. Each platform exercise program will be conducted 2 times a week for 12 weeks.~     The sessions will consist of a series of exercises on a Wave Pro-elite vibration platform~     (with 1-3 minute rests between sets) and stretches with the platform vibration either turned~     on (intervention group) or off (control group.) Quadriceps strength (primary outcome), leg~     press power, and vibration sense will be assessed at baseline and 12 weeks, and changed~     scores will be compared between groups.~   "
177661|NCT01239628|"~     The purpose of the protocol is to evaluate injection intervals and treatment modalities up to~     3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb~     spasticity after stroke.~   "
177662|NCT01239615|"~     Aim: To study the stability of brain MR-scanning parameters (blood-flow, microstructure,~     volume, metabolism) over 1 week in health volunteers.~      Hypothesis: MR-scanning parameters are stable over 1 week in healthy volunteers~   "
177647|NCT01239810|"~     Objective:~      To assess the impact of intraarticular hyaluronic acid (HA) on clinical outcome and on~     volumetric and T2 relaxation based changes of articular cartilage in mild to moderate~     osteoarthritis (OA) of the knee joint.~      Methods:~      Patients with moderate OA of the knee [Kellgren-Lawrence II] were recruited for a 6-months~     prospective, randomized clinical trial evaluating the effect of HA on articular cartilage~     morphology and composition. Clinical examinations and MRI were performed at baseline, and~     after 6, 12 and 24 weeks. Cartilage volume, thickness and surface area were determined in~     cartilage plates and subregions were defined using proprietary software. MRI was performed on~     a 1.5 Tesla scanner; morphological evaluation was performed using 3D T1-w FLASH~     Waterexcitation (WE) sequences and T2 maps were calculated from a multiecho, spin-echo~     sequence.~   "
177648|NCT01239797|"~     The purpose of the study is to determine whether the addition of Elotuzumab to~     Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).~   "
177649|NCT01239784|"~     The purpose of this project is to investigate the feasibility of using a home-based,~     parent-delivered model for providing neurodevelopmental rehabilitation programmes to infants~     who have had surgery for a complex heart defect.~   "
177650|NCT01239771|"~     The purpose of the study is to assess safety, tolerability and pharmacokinetics of TC-5214 in~     medically stable elderly subjects following multiple oral doses.~   "
177651|NCT01239758|"~     To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with~     Duchenne muscular dystrophy (DMD) who participated in Study A031-03. [Note: This study was~     terminated based on preliminary safety data. Pending further analysis of safety data and~     discussion with health authorities, a new ACE-031 trial will be planned.]~   "
177652|NCT01239745|"~     This non-interventional study will be conducted in several Eastern European countries to~     assess the safety, tolerability and efficacy of Aromasin® when it is administered in~     real-word setting in postmenopausal women with invasive estrogen receptor positive early~     breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and~     continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal~     therapy, to understand how Aromasin® is used in routine clinical practice, to assess~     adherence to prescribed Aromasin® treatment and to understand reasons for its early~     discontinuation.~   "
177653|NCT01239732|"~     This open-label, non-comparative, multi-center study will assess the safety profile and~     efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in~     participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal~     carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously~     (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the~     plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of~     8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80~     mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108~     weeks or until disease progression or unacceptable toxicity.~   "
177654|NCT01239719|"~     The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine~     fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of~     allergic dermatitis.~   "
177655|NCT01239706|"~     Prospective, Open Label, Cohort Study in Traumatic Brain Injury Patients. The goal of this~     study is to assess the safety of NTx®-265. NTx®-265 will be administered over 9 days, and~     patients will be followed for an additional 6 months.~   "
177656|NCT01239693|"~     The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have~     been associated with improved growth and development outcomes among infants in Ghana and~     Malawi. Modified versions of such supplements have been developed to improve their nutrient~     density and quality and to lower their costs. Such modified products have proven acceptable~     to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test~     the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating~     women and their infants from 6 to 18 months of age. In control groups, participants will~     receive either iron+folate tables during pregnancy only or multiple micronutrient tablets~     during pregnancy and first six months of lactations. The main hypothesis to be tested~     suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS~     between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and~     the first 6 months of lactation is higher than the mean LAZ score of same age infants who~     received no dietary supplements and whose mothers received iron-folate supplementation during~     pregnancy only.~   "
177657|NCT01239680|"~     Overall aim of this work is to evaluate new methods of resuscitation that can be applied by~     front-line responders on the battlefield, in civilian life, or which can be used during~     initial resuscitation in the first fixed facility to which the injured patient is brought.~   "
177658|NCT01239667|"~     Hypothesis and objectives of the study Systematic preparation of rehabilitation plan for~     rehabilitation in Phase III based on identification of self-care behavior patients with heart~     failure in NYHA class II and III, leading to patients' self-care behaviors strengthened,~     which will result in increased health status and ADL level 6 months after discharge from~     hospital with heart failure .~      Target~        1. To develop evidence-based clinical guidelines for patient rehabilitation phase III~        2. To test the effect of individual rehabilitation plans based on clinical guidelines for~          patient rehabilitation in Phase III. Efficacy evaluated in relation to changes in~          self-care behaviors, health status and ADL function.~      Material and Methods:~      Controlled longitudinal study. Each intervention patient receives before the end of hospital~     rehabilitation designed a specific rehabilitation plan also contacted the patient by~     specially trained nurse telephone 4 and 12 weeks after completion of their rehabilitation in~     hospital and the patient has the opportunity to contact the department when needed. The~     effect of rehabilitation assessed by sending questionnaires SF 36 and EHFScB Scale 9, to~     assess patients' ADL functioning, self-care behaviors and self-rated health.~      All patients participating in the planned rehabilitation in hospitals, so that the baseline~     is the end of Phase II. Intervention based on an analysis of the individual's need for~     continued rehabilitation (self care behavior, health status, ADL function) and the patient's~     perception of own situation. Draw up a plan and program together with the patient~   "
177659|NCT01239654|"~     It is an exploratory study evaluating a biological effect (stent strut coverage) using a~     novel technology such as OCT without any clinical implication.~   "
177663|NCT01239602|"~     Stem cell theray in old stroke patients is a study to treat stroke patients approved before~     in our hospital. We recruit these patients who received stem cell therapy and completed the~     study. We adopted movement-related cortical potential,and cortico-cortical inhibition to~     assess the stroke patients with or without stem cell therapy. Further analyzing the~     correlation of the motor related cortical potential and cortico-cortical inhibition among~     them. We wanted to find out if there are changes in cortical excitability in subjects with~     chronic stroke after stem cell therapy.~   "
177664|NCT01239589|"~     This study is being carried out to find out how patients suffering from the acute manic phase~     of bipolar disease are currently managed with Quetiapine Immediate Release (IR) or Quetiapine~     Extended Release (XR) in the hospital setting in real life practice, including length of~     stay.~   "
177665|NCT01239563|"~     The purpose of this study is to determine if anti-thymocyte globulin (Thymoglobuline)~     administration in the kidney transplant recipient is able to reduce the amount of damage that~     kidneys transplanted from deceased donors sustains on reperfusion.~   "
177666|NCT01239550|"~     The purpose of this study is to evaluate the effects of the medication insulin detemir on~     weight, brain function and mood, and on blood vessel and other risk factors for heart~     disease. The study will compare how diet and insulin detemir affect areas of the brain that~     are involved in food intake and the sense of pleasure people get from eating.~      Participants will be randomized into one of 2 groups. Group 1 will follow a low calorie diet~     only. Group 2 will follow a low calorie diet and take insulin detemir.~      The study is 26 weeks in length and include outpatient visits, inpatient visits, phone and~     email contact, questionnaires, diary collection, blood draw and procedures involving MRI and~     PET scans. There are 4 inpatient visits at the Vanderbilt Clinical Research Center (CRC). The~     inpatient visits require a one night 2 day stay on the CRC at Weeks 2, 6, 16, 26. During the~     weekly and bi-weekly outpatient visits participants will meet with the study nurse and~     dietitian.~   "
177667|NCT01239537|"~     In 2009 the World Health Organization (WHO) declared the Influenza A H1N1 (swine 'flu)~     outbreak the first global pandemic of this century. It is thought to have been responsible~     for 16,226 deaths globally as of 21st February 2010. The investigators know from previous~     influenza outbreaks that the number of cases also tends to increase during the winter season~     of the years after a pandemic. There is concern that last year's pandemic influenza strain~     will return this winter and it has, therefore, been included in WHO's recommendations for~     seasonal influenza vaccine combinations.~      This study will assess the duration of the immune response to the H1N1 influenza vaccines~     given last year, and how children will respond to this year's seasonal trivalent influenza~     vaccine (which includes the H1N1 strain). Participating children would receive one dose of a~     licensed seasonal influenza vaccine and blood tests would be taken before and after~     vaccination.~   "
177668|NCT01239524|"~     Breast reconstruction with a pedicled myocutaneous latissimus dorsi (LD) flap is a widely~     used reconstruction method. It is controversial if surgical denervation by transecting the~     thoracodorsal nerve should be performed or not. It is assumed that after denervation the~     latissimus dorsi muscle will significantly atrophy and lose volume. On the other hand~     discomforting signs and symptoms from muscle contraction are believed to be prevented if flap~     is denervated. The aim of the study was prospectively evaluate the influence of LD-flap~     innervation on the functional and aesthetic outcome of delayed breast reconstruction, and to~     compare the change in muscle structure in breast MRI and histopathology.~   "
177669|NCT01239511|"~     The objective of this study is to evaluate the dose-response of three different dose levels~     of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in~     patients with chronic stable angina.~   "
177670|NCT01239498|"~     The investigators hypothesize that injection of saline to the upper eyelids prior to~     lidocaine/adrenaline injection will reduce pain of the local anesthetic in comparison to~     injection of lidocaine alone.~   "
177671|NCT01239485|"~     The purpose of this study is to determine the maximum tolerable dose of irinotecan in~     combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric~     patient.~   "
177672|NCT01239472|"~     Currently, acute kidney injury is diagnosed by increased serum creatinine. However,~     creatinine is not a reliable marker for acute changes in renal function.~      The biology of the renal graft is influenced by chemokines from reperfusion and throughout~     its course with the development of interstitial fibrosis and tubular atrophy ubiquitously~     present in grafts of long-term survival. Moreover, the evaluation of changes in urinary~     cytokines may predict renal function and acute rejection episodes and their response to~     treatment.~      Today there are several studies comparing the relative immunosuppression of renal function,~     but few noticed its relationship with cytokines and chemokines. Thus, we propose to study the~     inflammatory consequences on blood and urine with the early withdrawal of calcineurin~     inhibitors (ICN), with renal biopsy in renal transplant patients before the change of~     immunosuppression and 9 months after.~   "
177673|NCT01239459|"~     Primary Objective:~      - To determine the effect of severe renal impairment on the pharmacokinetic profile of~     teriflunomide administered as a single 14 mg dose as compared to healthy subjects~      Secondary Objective:~      - To assess the tolerability of teriflunomide administered as a single 14 mg dose in subjects~     with severe renal impairment compared to subjects with normal renal function.~   "
177674|NCT01239446|"~     Mediastinal irradiation for treatment of malignancy increases the risk for coronary artery~     disease (CAD), while diabetes mellitus or other known risk factors can be absent at the time~     of the first coronary event. Radiation-induced atherosclerosis affects the coronary ostia and~     proximal coronary segments, or causes diffuse microvascular damage. Younger patients and~     those exposed to high radiation doses (> 35 Gy) have a higher risk for developing premature~     CAD and likely may benefit from coronary assessment.~      A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the~     individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA, improve the~     lesion detectability and sensitivity in patients with balanced diffuse lesions as well as the~     specificity and mainly PPV of CTCA.~      The aim of the study is to perform hybrid SPECT/CTCA in asymptomatic patients with HL who~     have received radiotherapy to the mediastinum in order to allow an early diagnosis of~     hemodynamically significant CAD that will need further therapeutic interventions.~   "
177677|NCT01239407|"~     The purpose of this study is to determine if a culturally focused psychiatric (CFP)~     consultation service can improve depressive symptoms and increase diagnosis and treatment of~     depression in Asian American and Latino American primary care patients at the Massachusetts~     General Hospital.~   "
177678|NCT01239394|"~     Ofatumumab is a drug that works by attaching to the CD20 molecule found on the surface of~     cancerous B cells, and then triggering the death of those cells. It is approved by the FDA~     for treatment of another B-cell cancer, chronic lymphocytic leukemia, and also has evidence~     of success in people who's B-cell lymphomas have relapsed after initial treatments. In this~     research study we are looking to see if ofatumumab is effective and safe in treating~     previously untreated B-cell NHL.~   "
177679|NCT01239381|"~     Stereotactic body radiation therapy (SBRT) is a technique that is used to deliver radiation,~     to sites in the body. All participants in this study will be treated with SBRT using proton~     beam radiation. Proton beam radiation uses tiny particles to deliver radiation to tumors. The~     purpose of this research study is to determine if SBRT with protons will prevent tumor growth~     and reduce the treatment side effects for liver metastases.~   "
177680|NCT01239368|"~     Background:~      - Cancer development is associated with problems in immune system functions, which prevent~     the body from attacking and destroying the abnormal cells that lead to tumor growth. Research~     has suggested that certain white blood cells, known as Th1 and Th2 T cells, are affected in~     individuals with some kinds of cancer -- when the proportion of Th2 cells is greater than Th1~     cells, the immune system s ability to fight off the growth of malignant tumors is weakened.~     Researchers are interested in determining if an infusion of specially modified Th1 cells, in~     addition to stem cell transplant, is a safe and effective treatment for individuals with~     forms of multiple myeloma that might not respond well to standard treatments alone.~      Objectives:~      - To determine the safety and effectiveness of the infusion of modified Th1 white blood~     cells, in conjunction with standard treatment, as a treatment for individuals who have been~     diagnosed with high-risk forms of multiple myeloma.~      Eligibility:~      - Individuals age 18 to 75 who have been newly diagnosed with high-risk multiple myeloma and~     who have received no or minimal treatment (4 months or less) yet..~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and imaging studies. Some participants may also have a bone marrow or other~          type biopsy to evaluate the state of their disease.~        -  White blood cells will be collected from the participants through an apheresis~          procedure, which will collect and separate the white blood cells and return the rest of~          the blood to the participant.~        -  The collected cells will be grown and expanded under special conditions in the~          laboratory and stored frozen until participants receive all the standard of care~          treatment for multiple myeloma, including a stem cell transplant.~        -  Participants will receive an infusion of the modified Th1 cells a few weeks after the~          transplant, and will remain in the hospital for a few days after receiving the cells to~          monitor the possible immediate effects of the treatment.~        -  Participants will have regular follow-up visits to study the long-term effects of the~          modified Th1 cell infusion....~   "
177681|NCT01239355|"~     This phase II trial is studying how well MK2206 works in treating patients with advanced~     liver cancer that did not respond to previous therapy. MK2206 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
177682|NCT01239342|"~     This randomized phase II trial studies the side effects and how well Akt inhibitor MK2206 or~     everolimus works in treating patients with kidney cancer that does not respond to treatment.~     Akt inhibitor MK2206 and everolimus may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Everolimus may also stop the growth of kidney cancer by~     blocking blood flow to the tumor. It is not yet known whether Akt inhibitor MK2206 or~     everolimus is more effective in treating kidney cancer.~   "
177683|NCT01239329|"~     Underweight is more prevalent in people with a mental handicap than in people without a~     mental handicap, especially in people with a severe mental handicap. It is unknown if these~     people are malnourished. There is no validated screening instrument available to determine~     the nutrition status in people with complex multiple disabilities. Research regarding~     malnutrition based on body composition and nutrients in stead of anthropometric data is~     important.~      The aim of the study is to understand the nutritional status of people with complex multiple~     disabilitiest through measurement of body composition and nutritients. The primary objective~     of the study is: What percentage of people with complex multiple disabilities are~     malnourished, based on altered body composition and nutritients? Understanding the~     nutritional status of these patients is important in order for them to receive appropriate~     and effective treatment. This treatment is of interest for general health and the quality of~     daily life.~   "
177684|NCT01239316|"~     This phase II trial studies how well vismodegib works in treating younger patients with~     recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells.~   "
177685|NCT01239303|"~     During exercise, splanchnic perfusion is compromised, resulting in organ damage in healthy~     individuals. Improving the availability of NO might result increase splanchnic perfusion and~     prevent organ damage during exercise.~   "
177686|NCT01239277|"~     Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is~     to test whether combined nutrient intake plays an important role in stimulation of the muscle~     protein growth in elderly people; and whether it represent effective strategies to overcome~     the impaired muscle protein synthesis in elderly when compared with young subjects.~   "
177687|NCT01239251|"~     The purpose of this study is to test the ease of using a new device, called the GlowCap that~     reminds the patient to take their breast cancer hormone pill. The study will collect~     information about the experience with this device and what the patient thinks of its role in~     the daily pill taking routine.~   "
177688|NCT01239238|"~     The purpose of the present proposal was to investigate the predictive properties of markers~     in exhaled breath to predict an asthma exacerbation. In addition, the reliability of home~     monitor assessments to measure asthma control will be examined.~   "
177696|NCT01239134|"~     TRX518-001 is an open label, non-randomized single group assignment, Phase 1 single dose~     escalation study in adults with biopsy proven unresectable Stage III or Stage IV melanoma or~     other solid tumor malignancies.~      Part A: The study objectives are to determine the safety, tolerability, pharmacokinetic (PK)~     and pharmacodynamic (PD) profiles of TRX518 and to define the maximum tolerated dose at which~     there are tolerable side effects and/or maximum PK/PD parameter changes.~      Subjects will be assigned to a cohort in the order screening is completed. Dose will depend~     upon the cohort in which a subject is enrolled and cohorts will be dosed consecutively by~     ascending dose. Part A has been completed.~      Part B: A Dose-Escalation Study of Multi-dose TRX518 Monotherapy with objectives including~     characterization of the safety, tolerability, and pharmacokinetics, as well as, evaluate for~     evidence of anti-tumor activity and assess TRX518 immunogenicity.~      Part C: An Expansion Cohort of Multi-dose TRX518 Monotherapy at the Maximum Tolerated Dose~   "
178820|NCT01224379|"~     Does a new topping-off device lead to a better clinical outcome compared to standard~     fusion? Does this device prevent the development of adjacent instability? Does radiological~     adjacent instability correlate with clinical outcome?~   "
177689|NCT01239225|"~     Abdominal aortic aneurysms (AAA) are localized, blood-filled dilations (balloon-like bulges)~     of the aorta. Approximately 90% of abdominal aortic aneurysms occur infrarenally (1). It is~     most commonly asymptomatic and can be detected randomly during screening. Its prevalence rate~     in men aged 65 years and more is 5 - 8% (3).~      The risk factors for the occurrence of AAA are male gender, advanced age, history of~     atherosclerosis, cigarette smoking and 1st degree family history (4).~      The prevalence rate is higher in patients with history of atherosclerosis of peripheral blood~     vessels and coronary arteries (5 - 7). As the size of an aneurysm increases, there is an~     increased risk of rupture, which can result in severe hemorrhage and death. The death rate~     due to rupture in the elderly population is 90% (3, 8). Elective surgical repair of the~     abdominal aortic aneurysm is associated with a death rate of 8% (9). Therefore, the~     importance of the screening of populations at elevated risk is obvious (5 - 7, 10 -14). Among~     imaging techniques, ultrasonographic screening for abdominal aortic aneurysm is technically~     simple, accurate and devoid of ionizing radiation. Ultrasonographic diagnosis of AAA is~     associated with a major reduction in the incidence of abdominal aortic aneurysm-related~     mortality (15 - 19). The sensitivity of ultrasonographic screening for abdominal aortic~     aneurysm is about 100% (19). The most common clinical indications for ultrasonographic~     screening for abdominal aortic aneurysm are a palpable abdominal mass, hemodynamic impairment~     of aortic system in lower extremities, pain in the chest, lower back or scrotum, and~     abdominal bruits.~      Ultrasonography is used to screen for aneurysms when the outer aortic diameter is more than 3~     cm (normal diameter of the aorta is around 2 cm (20). There is disagreement regarding the~     follow-up of patients after detection of abdominal aortic aneurysm in diameter of 2.6 cm -~     2.9 cm (22). Random detection of abdominal aortic aneurysm where the aortic diameter is 2.6~     cm, in men aged 65 years and more, have been associated with no risk for its future~     significant development (21). Ultrasonographic evaluation of abdominal aorta is a challenge~     for clinicians because of the need for the accurate detection of aortic diameter (20).~   "
177690|NCT01239212|"~     The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg~     loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with~     seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading~     dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady~     state drug levels of levetiracetam in neonates.~   "
177691|NCT01239199|"~     Background:~      It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide~     (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of~     family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of~     passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators~     noticed at the child's a positive relation with the environmental tobacco smoke~      Objective: the investigators objective is to bring to light that the rise of the eNO, a non~     invasive biomarker of the bronchial inflammation, would be a risk factor expected from~     passage of recurrent wheezing of the infant and the young child (of less than 36 months old)~     towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing~     established, the investigators estimate by questionnaire the severity of the asthma, the~     personal and familial atopy, the collection of the environmental data. After allergic~     exploration (skin tests and assay of serum total and specific IgE, complete blood count), the~     eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer.~     Annually, a questionnaire will be send to families to appreciate the persistence or the~     remission of the asthma. After a simple descriptive analysis of the population and a~     multifactorial descriptive analysis, the investigators shall look for the connections between~     the rise of the eNO and the various clinical, biological and environmental parameters known~     to influence the variations of this marker. Then the investigators shall select a set of~     explanatory variables for a multivariate analysis by a logistic regression step by step.~   "
177692|NCT01239186|"~     This study will analyse the sperm global methylation status of 62 infertile men before~     assisted reproductive techniques. Some of these patients (20%) present hypomethylation of H19~     locus. A global methylation analysis may reveal others imprinting defects.~   "
177693|NCT01239173|"~     Converging lines of evidence have implicated the amygdala in the pathophysiology of~     posttraumatic stress disorder.~      The primary purpose of our study is to assess the effect of propanolol, a beta adrenergic~     antagonism, on amygdala activation during a symptom provocation state in traumatized subjects~     with and without posttraumatic stress disorder.~   "
177694|NCT01239160|"~     The treatment of lymphedema has been a major focus of attention for physicians and scientists~     for several decades. At this time, no successful techniques have been developed to prevent~     lymphedema, and therefore, a great deal of emphasis is placed on treatment modalities that~     can lessen the severity and impede the progression of this debilitating condition.~      The treatment on offer usually consists of a maintenance phase using compression garments and~     an intensive treatment phase, which includes the use of skin care, compression bandaging,~     exercise and manual lymphatic drainage (MLD). The intensive phase is usually described as~     complex decongestive therapy (CDT). This is time consuming and requires high resource usage.~     Pneumatic compression devices (PCD) offer and alternative to MLD and can be used by the~     patient. There are a number of devices on the market that are categorized into 1. without~     calibrated gradient compression 2. With calibrated gradient compression.~      This trial will compare two PCDs, a simple device without calibrated compression, and an~     advanced device with calibrated compression, in the reduction of swelling and maintenance of~     reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will~     be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.~   "
177695|NCT01239147|"~     Epidemiological studies suggest that whole grain consumption affects measures of obesity~     including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate~     rather consistently an inverse association between BMI and whole grain consumption.~     Furthermore, prospective cohort studies suggest that people with high whole grain consumption~     have less risk for body weight gain compared with low whole grain consumption.~      The purpose of this study is to assess the effects of inclusion of whole grain in the diet on~     anthropometric measures, particularly abdominal fat regain after a weight loss diet.~      It is anticipated that the short-term regain of abdominal fat after a weight loss diet is~     lower in volunteers consuming whole grain than in volunteers consuming refined grain.~   "
177697|NCT01239121|"~     Medication reconciliation, a process by which a provider obtains and documents a thorough~     medication history with specific attention to comparing current and previous medication use,~     can prevent medication-related errors and harm. The aims of this study are: 1) To adapt~     medication reconciliation to include information from a computerized regional health~     information exchange (RHIO) in the Bronx, 2) To conduct a trial of the adapted medication~     reconciliation process and examine effects on medication errors, harm, and hospital costs,~     and 3) To identify factors that are barriers to adoption of the RHIO tool by James J. Peters~     (Bronx) VA providers. Findings from this project will provide an understanding of the effect~     of the RHIO tool on reducing harmful VA and non-VA medication use. It will also provide~     information on the feasibility of incorporating RHIO tool use into every day work flow for~     pharmacists and physicians.~   "
177699|NCT01239095|"~     Colorectal cancer is the third most common form of cancer found in the United States. To date~     surgical resection provides the best chance for cure. Unfortunately, despite curative~     surgery, tumor recurrences develop in 30-40% of patients from either unforeseen residual~     metastases or from viable tumor cells shed into the circulation before or at the time of~     surgery. There is evidence from both humans and mice suggesting that tumor growth is~     stimulated after surgery for a period of time.~      This study calls for the administration of a green tea extract and a milk thistle extract,~     two orally ingested supplements, during the week immediately before and weeks after your~     surgery. It is not the current standard of care to give anti-cancer drugs during the~     perioperative period. The basic idea behind this study is that it should be beneficial to~     inhibit cancer growth in the days leading up to and following surgery. Why is this the case?~      It makes sense to limit or inhibit tumor growth before surgery with drugs provided it can be~     done safely and does not interfere with the surgery. It is also logical to give anti-cancer~     drugs after surgery because, unfortunately, about 35 percent of colorectal cancer patients,~     after resection, have hidden tumor cells that remain in the body. There is also strong human~     evidence that tumor growth is stimulated during the first month after tumor resection as a~     result of the surgical injuries and the healing process. Therefore, there is good reason to~     give anti-cancer drugs as soon as possible after surgery in order to offset some of surgery's~     negative effects.~      Although both supplements have been given safely to a wide variety of patients with a number~     of different medical problems, the two supplements together have never been given to cancer~     patients during the weeks just before and following surgery. We hypothesize that the~     administration of these two supplements together will be safe in the period surrounding~     colorectal cancer surgery.~   "
177700|NCT01239082|"~     Colorectal cancer (CRC) is currently the second most common cause of cancer death in the~     United States, and one of the most preventable cancers. It has been shown in several~     randomized controlled trials that screening using fecal occult blood testing (FOBT) reduces~     CRC mortality by 13-33%. While there is strong consensus amongst experts regarding the value~     of CRC screening, the best approach to screening is not clear. Of the widely recommended~     modalities, FOBT and colonoscopy are the most commonly used within the United States. FOBT is~     inexpensive, non-invasive, and its use as a screening tool is supported by the highest~     quality evidence (i.e. randomized controlled trials). Moreover, newer FOBT, such as fecal~     immunochemical tests or FITs, have advantages over conventional FOBT in terms of both test~     characteristics and ease of use that make them quite attractive as a population-based~     screening tool.~      While colonoscopy is invasive and has higher up-front risks and costs than FOBT, it does~     afford the opportunity to directly assess the colonic mucosa and is widely believed to be the~     best test to detect colorectal cancer. In addition, colonoscopy allows for the detection and~     removal of colorectal adenomas -a well recognized colorectal cancer precursor. There is~     indirect evidence that suggests colonoscopy is effective in reducing colorectal cancer~     mortality, but to date, no large clinical trials have been completed to support this~     assumption. While colonoscopy use is increasing, data is emerging that colonoscopy may not be~     as effective as previously believed. Prior support for colonoscopy as a screening test relied~     upon effectiveness estimates that now appear to be overly optimistic. Given the invasive~     nature of colonoscopy, the associated small, but real risk of complications, and dramatically~     higher costs than other screening tests, it is especially important to determine the true~     comparative effectiveness of colonoscopy relative to other proven non-invasive options.~      The investigators propose to perform a, large, simple, multicenter, randomized, parallel~     group trial directly comparing screening colonoscopy with annual FIT screening in average~     risk individuals. The hypothesis is that colonoscopy will be superior to FIT in the~     prevention of colorectal cancer mortality measured over 10 years. Individuals will be~     enrolled if they are currently eligible for CRC screening (e.g. no colonoscopy in the past 10~     years and no FOBT in the past 1 year) and are between 50 and 75 years of age. The~     investigators will exclude individuals for whom colonoscopy is indicated (e.g. signs or~     symptoms of CRC, first degree family member with CRC, personal history of colorectal~     neoplasia or inflammatory bowel disease).~      All participants will complete baseline demographic, medication, and lifestyle questionnaires~     (e.g. diet, non-steroidal anti-inflammatory use, frequency of exercise) prior to~     randomization in a 1:1 ratio to either screening colonoscopy or annual FIT screening (Figure~     1). Those testing positive by FIT will undergo evaluation to determine appropriateness for~     colonoscopy. Screening will be performed in a manner consistent with the currently accepted~     standard of care in order to determine the comparative effectiveness of the two screening~     strategies. Participants will be surveyed annually to determine if they have undergone~     colonoscopy or been diagnosed with CRC.~      The primary study endpoint will be CRC mortality within 10 years of enrollment. The secondary~     endpoints are (1) the incidence of CRC within 10 years of enrollment and (2) major~     complications of colonoscopy. Mortality will be determined through queries of the VA Vital~     Status File. Cause of death will be determined primarily using death certificates from the~     National Death Index-Plus database, augmented by adjudication of medical records for known~     CRC cases where CRC is not listed as a cause of death on the death certificate. The~     investigators postulate that screening colonoscopy will result in a 40% reduction in CRC~     mortality over 10 years relative to annual FIT screening. Using a log-rank test with a~     2-sided test of significance, =0.05, a sample size of 50,000 participants will be required to~     test the primary hypothesis with 82% power, assuming a 1% annual rate of crossover from FIT~     to colonoscopy and a 0.5% annual rate of loss to follow-up. The planned study duration is~     12.5 years with 2.5 years of recruitment and 10 years of follow-up for all enrolled~     participants.~   "
177701|NCT01239069|"~     Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for~     the Treatment of Dry Eye Disease~   "
177702|NCT01239056|"~     The purpose of this study is to study the evaluation of the effectiveness of endoscopic~     Pancreatic Pseudocyst drainage using a metal stent.~   "
177703|NCT01239043|"~     The purpose of this trial is to describe antibody persistence and response to re-vaccination~     with either Menactra® or Menomune® vaccine approximately three years following initial~     vaccination in adults who participated in trial MTA29 (NCT00874549).~      Objectives:~        -  To describe the rates of immediate reactions, solicited injection-site and systemic~          reactions, all unsolicited adverse events, and serious adverse events following~          vaccination.~        -  To evaluate persistence of serum bactericidal antibodies in subjects who received~          Menactra® or Menomune® vaccine approximately three years ago.~        -  To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects~          re-vaccinated with either Menactra® or Menomune® vaccine.~   "
177704|NCT01239030|"~     This multi-center parallel study is designed to study the efficacy and safety of fixed doses~     of methylphenidate extended release (ER)capsules of three dose levels compared with a placebo~     group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are~     between 6 and 18 years old.~   "
177705|NCT01239017|"~     This is a double-blind, prospective, randomized study in which patients will be randomized to~     1 of 5 treatment arms (4 active and 1 placebo).~      Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either~     REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving~     REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive~     placebo SC.~   "
177706|NCT01239004|"~     The present study will assess the low-density lipoprotein cholesterol (LDL-C) lowering effect~     of colesevelam as an adjunct to niacin for the improvement of lipids and glycemic control in~     dyslipidemic subjects with impaired fasting glucose.~   "
177707|NCT01238991|"~     The purpose of this long term extension study is to assess safety, tolerability and~     immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD~     who were randomized in the preceding P2 double blind studies.~   "
177708|NCT01238978|"~     The study will assess the incidence of Hypoglycemia: Percent of patients presenting no~     hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM~     patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin~   "
177709|NCT01238965|"~     Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin calcium, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving panobinostat together with fluorouracil and leucovorin calcium may~     kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and the best~     dose of giving panobinostat, fluorouracil, and leucovorin calcium together in treating~     patients with stage IV colorectal cancer who did not respond to previous fluorouracil-based~     chemotherapy.~   "
177710|NCT01238952|"~     The primary objective is to determine the maximum tolerated dose/recommended phase II dose of~     the combination regimen of NK012 and carboplatin in patients with advanced solid tumors.~   "
177711|NCT01238939|"~     The primary objective is to determine the maximum tolerated dose/recommended phase II dose of~     the combination regimen of NK012 and 5-fluorouracil in patients with advanced solid tumors.~   "
177712|NCT01238926|"~     This experiment seeks to determine whether individuals with PD will benefit from vitamin B6~     (pyridoxine hydrochloride), B12 (cyanocobalamin), and Folic Acid supplementation, whether~     they will benefit from a 6-week circuit training program, or whether they will benefit from a~     combination of the two interventions. The outcome variables will include: plasma~     homocysteine, GSH:GSSG ratio, cognitive function, balance, strength, functional activities,~     kinematic gait analysis, and a quality of life questionnaire.~   "
177713|NCT01238913|"~     The evaluation of using metal stents as medically indicated for the treatment of benign~     esophageal lesions.~   "
177714|NCT01238900|"~     The purpose of this study is to study the evaluation of the use of metal stents as part of~     the treatment of benign biliary strictures.~   "
177729|NCT01238705|"~     This randomized,active controlled study aimed to compare the effects on sexual function of~     treatment with combined antihypertensive drugs.~      The researchers hypothesize that:~        1. Both felodipine-irbesartan combination and felodipine-metoprolol combination are~          effective in lowing blood pressure in patients with essential hypertension.~        2. Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex~          hormone,whereas felodipine-irbesartan combination does not impair sexual function and~          does not change hormone levels.~        3. Oxidative stress decline after both combination regimens. Felodipine-irbesartan~          combination has a greater impact on oxidative stress indicators than~          felodipine-metoprolol combination.~   "
177901|NCT01236456|"~     The primary endpoint of this study is to determine what percentage of patients receiving~     high-dose Cyclophosphamide may experience a halt in the worsening of their disease or~     experience improvement of their disease and for how long the benefit may last.~   "
177715|NCT01238887|"~     Despite widespread efforts to improve the treatment of obesity, only limited progress has~     been made. Calorie restriction (CR) has consistently been shown to produce weight loss, as~     well as delay the onset of age-related diseases, in numerous species. Most overweight~     individuals, however, are unable to sustain CR induced weight losses, possibly due to~     internal feedback systems that signal the body to increase food intake or decrease energy~     expenditure in response to weight loss. Novel treatment approaches are thus urgently needed~     that can assist overweight individuals in adhering to a CR regimen over the long-term.~      Botanicals represent an important and underexplored source of potential new therapies that~     may facilitate CR. In particular, one promising botanical that may reduce food intake and~     body weight by affecting neuroendocrine pathways related to satiety is Garcinia Cambogia~     (Garcinia Cambogia Desr.)-derived (-)-hydroxycitric acid. This compound has been found to~     facilitate weight loss in a number of studies. To date, few studies have directly tested the~     effect that this botanical on food intake in humans, its mechanism of action, or its effect~     on oxidative stress levels; thus rigorous scientific studies on this compounds need to be~     conducted. A double-blind, placebo-controlled crossover study will be conducted to explore~     the role that two different doses of this botanical compound have on food intake, satiety,~     weight loss, and oxidative stress levels. It is hypothesized that compared to placebo, both~     doses of Garcinia Cambogia (hydroxycitric acid) will reduce food intake, increase satiety,~     decrease weight, and reduce oxidative stress levels.~   "
177716|NCT01238874|"~     The Latin America CRT Study is a prospective, multicenter, interventional post-market release~     study conducted in Latin America. The geography includes Puerto Rico and the Caribbean,~     Mexico and Central America, and South America.~   "
177717|NCT01238861|"~     The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous~     administrations of MEDI-563 on adults with uncontrolled asthma.~   "
177718|NCT01238848|"~     The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline~     in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital~     stay, oxygen requirements and clinical outcome.~   "
177719|NCT01238835|"~     A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating~     the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; study valve), the next~     generation Ascendra™ transapical delivery system, and crimper accessories.~   "
177720|NCT01238822|"~     Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of~     neuropsychological dysfunction including response inhibition, working memory, and attention.~     One neuropsychological outcome measure that consistently reveals between-group differences is~     response variability. However, until recently, differences in response variability have been~     reported as an ancillary finding or viewed as a nuisance in the analyses. The specific aims~     of the present study are to 1) Examine response variability in ADHD patients across~     neuropsychological tasks to understand the breadth of this specific deficit and to understand~     the relation between response variability and other neuropsychological outcome measures; 2)~     Assess whether response variability deficits are specific to either or both of the two most~     prevalent ADHD subtypes (i.e., Combined Type [CT] and Predominantly Inattentive Type [PIT]);~     3) Determine whether response variability in ADHD patients is affected by either medication~     or a variety of environmental manipulations (e.g., reward); and 4) Understand the~     relationship between neuropsychological measures of response variability and naturalistic~     instances of variable performance. Forty-five children (aged 7-11) with ADHD-CT, 45 children~     with ADHD-PIT, and 45 normal controls will be recruited to examine response variability~     across a wide range of neuropsychological tests. Task parameters such as event rate, stimulus~     saliency, and the presence of operant reward will be modified on each test to determine the~     conditions under which response variability is manifested in children with ADHD. In addition,~     all children with ADHD will participate in a placebo-controlled, randomized medication trial~     with a psychostimulant medication to assess the effects of medication on response~     variability. Advanced analytic methods utilizing non-Gaussian distributions and fast Fourier~     Transforms of the reaction time data will be used to conduct detailed analyses of RT patterns~     across the ADHD and normal control groups. Further, the effects of task parametric~     manipulations and medication on response variability will be examined. Finally, relations~     between response variability on neuropsychological tests and response variability in a~     variety of real-world analog situations will be examined to evaluate the ecological validity~     of these deficits.~   "
177721|NCT01238809|"~     The purpose of this study is to assess in general population low-dose aspirin and~     gastroprotective agent compliance and reasons for bad compliance~   "
177722|NCT01238796|"~     The purpose of this study is to evaluate the effect of renal function on the biological~     activity of telavancin using blood samples obtained from subjects with normal renal function,~     severe renal impairment, and end stage renal disease.~   "
177723|NCT01238783|"~     To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for~     treatment of bacterial conjunctivitis~   "
177724|NCT01238770|"~     The current trial shall clarify the potential of the multitarget antiangiogenic tyrosinkinase~     inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage~     treatment in patients with recurrent, pretreated ovarian cancer.~   "
177725|NCT01238757|"~     The purpose of this study is~        -  to document the prevalence and type of asynchronies incidence during non-invasive~          mechanical ventilation in pediatric patients breathing under pressure support.~        -  to observe the impact of adjusting the expiratory trigger setting on asynchronies during~          pressure support~        -  and compare these incidences with asynchronies measured in pediatric patient breathing~          under NAVA system (Neurally Adjusted Ventilatory Assist).~   "
177726|NCT01238744|"~     The effect of a single dose of flaxseed mucilage incorporated into either drinks or tablets~     will be tested in term of their effect on appetite sensation measured using visual analogue~     scales over 120 minutes and ad libitum energy intake hereafter in two studies.~   "
177727|NCT01238731|"~     Background: Persistent severe pulmonary hypertension (PH) after mechanical valve replacement~     is a frequent finding in patients with severe valve-diseases. The reasons to develop PH are~     multifactorial and the prevalence of severe PH significantly worsens the patients´ outcome.~      Aims: (i) To define the prevalence of PH in patients after valve replacement and (ii) to~     identify factors predicting persistent PH.~      Methods: All patients which underwent valve replacement at our institution between the years~     2008 -2010 will be screened retrospectively. Those patients with pre- procedural proven PH by~     means of right-heart catheterization will receive prospective follow-up with~     echocardiography. Diagnosis of persistent PH will be confirmed with right heart~     catheterization.~   "
177728|NCT01238718|"~     Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The~     incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased~     in patients that receive rapid sequence induction and intubation, where opioids are spared~     and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that~     lidocaine when administered intravenously in patients who undergo rapid sequence induction~     may not only blunt the hemodynamic response to intubation, but may also increase the~     anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension,~     arrhythmias and also awareness.~   "
177730|NCT01238692|"~     The purpose of the study is to examine both efficacy of LBH589 in treating relapsed and~     refractory DLBCL, and added benefit of combining rituximab with LBH589 in this setting.~     Tissue samples from accessible lymph nodes will be collected and banked before the start of~     the study treatment and after 15 days. Additionally, blood samples will be drawn and stored~     in the tissue biobank.~   "
177731|NCT01238679|"~     This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a~     number of ascending doses administered for 14 days in healthy volunteers.~   "
177732|NCT01238666|"~     This study was designed in two phases: Phase I is designed to confirm that the surgeon is~     able to perform accurate liver surface registration including standard liver features used as~     landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of~     comfort with the procedure.~      The surface of the liver will be manually swabbed with the study tracked laparoscopic probe~     with landmarks noted during data collection. After registration of the liver is obtained, the~     registration points obtained during this procedure will be evaluated by the surgeon by moving~     the tracked laparoscopic probe over the liver surface and evaluating the location of the~     tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The~     surgeon will accept or reject the registration accuracy.~      The hypothesis is that the surgeon will be able to successfully acquire liver surface~     registrations with a small learning curve for technique and will be able to proceed to Phase~     II of the study.~      Phase II contains the registration process included above but adds the additional process of~     tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder~     Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked~     and displayed on the Pathfinder three dimensional (3D) image.~      The surgeon will use ultrasound (US) guidance to locate tumor location during the~     laparoscopic procedure. The images collected during this process will be recorded by~     Pathfinder.~   "
177733|NCT01238653|"~     This study was designed to confirm that the surgeon is able to perform accurate liver surface~     registration including standard liver features used as landmarks during a scheduled~     laparoscopic liver procedure. The hypothesis is that there will be no clinically relevant~     difference between the error measurements obtained during the laparoscopic procedures in this~     study when compared with those obtained during previous open liver registration studies.~      The surface of the liver will be manually swabbed with the study tracked laparoscopic probe~     with landmarks noted during data collection. After registration of the liver is obtained, the~     registration points obtained during this procedure will be evaluated by the surgeon by moving~     the tracked laparoscopic probe over the liver surface and evaluating the location of the~     tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The~     surgeon will accept or reject the registration accuracy.~   "
177734|NCT01238640|"~     The purpose of this study is to assess the bioequivalence between two new oral nicotine~     replacement therapy products and Nicorette® microtab.~   "
177735|NCT01238627|"~     The purpose of this study is to assess the bioequivalence between two oral nicotine~     sublingual tablets, 2 mg and 4 mg.~   "
177736|NCT01238614|"~     The CHICA system is a clinical decision support system that uses adaptive turnaround~     documents to provide point-of-care information to clinicians. We will be studying whether it~     can help in the diagnosis and referral of mothers with maternal depression.~   "
177737|NCT01238601|"~     The purpose of this study is to determine how different types of breast implants contour to~     the chest wall.~   "
177738|NCT01238588|"~     The hypothesis is that switching calcium based phosphate binders to sevelamer carbonate will~     be associated with less inflammation including less atherosclerotic plaque inflammation~     (inflammation of the vessel walls).~   "
177739|NCT01238575|"~     The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself~     or in combination with methylphenidate (also known as Ritalin) is helpful for treating~     hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).~   "
177740|NCT01238562|"~     This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a~     single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish~     dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).~   "
177741|NCT01238549|"~     The field of spinal cord injury (SCI) rehabilitation medicine lacks a reliable, patient~     reported, health-related quality of life measurement tool. The National Institute of Health~     has provided funding to develop a SCI-specific, quality of life (QOL) survey tool in~     non-Veterans with SCI called the SCI-QOL. This quality of life survey asks questions~     regarding physical/medical, emotional, and social health as it relates to individuals with~     spinal cord injury.~      The purpose of this study is to include a Veteran population in the making of the quality of~     life survey. Each participant will be asked to complete a packet of quality of life~     questions. Participants will be given the opportunity to take the survey a second time,~     either 7-14 days or 5-7 months after the first survey. Taking the survey twice will allow the~     research team to test the reliability of the survey. Comparing the SCI-QOL with other legacy~     measures will allow the investigators to test the validity of the survey.~      Additionally, the investigators will be testing the SCI-QOL between Veterans and non-Veterans~     with SCI to determine if there are differences in their self-reported quality of life.~      This study will be recruiting participants at the James J. Peters Veterans Affairs Medical~     Center (VAMC) in Bronx, New York and the James A. Haley Veterans Affairs (VA) Hospital in~     Tampa, Florida. The James J. Peters VAMC will be recruiting 125 participants and the James A.~     Haley VAH will be recruiting 275.~   "
177742|NCT01238536|"~     The broad, long-term objective of this research protocol is to improve the quality of life~     for patients suffering from lumbar spinal stenosis. This objective will be met by examining~     the safety and clinical efficacy of epidural steroid injections for treatment of pain~     associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled~     trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections~     (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older~     adults with lumbar spinal stenosis.~   "
177902|NCT01236443|"~     A Study to identify toxicity and optimal photodynamic treatment parameters using the~     photosensitizer 2-[1-hydroxyethyl]-2-devinylpyropheophorbide-a (HPPH) in high grade~     dysplasia, carcinoma-in-situ, or early adenocarcinoma in Barrett's esophagus.~   "
177743|NCT01238523|"~     Tibial shaft fracture is one of the most common fractures in children and adolescents. It~     encompasses approximately 15 % of all long-bone fractures and is third behind only fractures~     of the femur and both bones of the forearm. (2). Although most authorities agree that closed~     tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no~     clear consensus as to when to allow weight bearing on the injured extremity. While most~     recent articles have recommended long-leg casts with the knee bent in flexion of 30-60~     degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less~     flexion, 0-5 degrees, to encourage early weight bearing.(5).~      The purpose of this randomized controlled prospective study is to determine if the position~     of immobilization of the knee influences the rate of healing, delayed union, and nonunion As~     well, we will assess if the type of immobilization affects the function of the patient during~     the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child~     self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a~     total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the~     tibia, with or without fracture of the fibula, will be included in the study~   "
177744|NCT01238510|"~     In the setting of single stent strategy for treatment of bifurcation, we investigate to~     compare simple strategy as provisional final kissing balloon technique(fKBT) to complex one~     as routine FKBT, focusing on actual myocardial ischemia assessed by scintigraphy in 7-month~     and to examine optimal endpoint of side branch ostium.~   "
177745|NCT01238497|"~     This registry is to expand upon existing data sets, to identify patient characteristics and~     indicators related to complications and clinical benefits for patients with symptomatic~     severe calcific degenerative aortic stenosis that are undergoing treatment with the~     commercially available Edwards SAPIEN XT™ Valve, and delivery devices.~   "
177746|NCT01238484|"~     The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is~     effective in treating contracture for patients with Ankle Equinus secondary to diabetes~     mellitus.~   "
177747|NCT01238471|"~     In premature infants, propranolol (Prop) treatment might suppress continuing~     neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP)~     towards its severe stages (III-V), thus avoiding the need of interventions (CRYO and/or LASER~     photo-coagulation of the ischemic retina and preventing severe ocular sequelae. We therefore~     plan to prospectively investigate the influence of prop versus placebo in VLBW infants with~     ROP stage 1 (zone I), with stage 2 or higher (any zone) or with Plus disease, along with~     close follow up regarding safety of prop administration and its effect on ROP.~   "
177748|NCT01238458|"~     This study will recruit a total of 150 evaluable subjects (30 cognitively normal volunteers,~     and 60 MCI(Mild cognitive impairment), and 60 AD(Alzheimer's disease), respectively) Each~     evaluable subject involved in this study must fulfill all the inclusion and exclusion~     criteria according the subject grouping.~      Safety measurement will be evaluated by medical history, vital signs, physical examinations,~     laboratory examinations and collecting of adverse events.~      This study is expected to be completed in a period of 3 years.~   "
177749|NCT01238445|"~     Bronchiolitis is a significant cause of morbidity and hospitalizations in children,~     accounting for more than 125,000 hospitalized children per year in the United States.~     Although treatment is largely supportive, bronchodilator medications such as albuterol are~     frequently used due to increased pulmonary resistance in this population.2-4 However, despite~     four decades of clinical trials, the efficacy of albuterol in the treatment of bronchiolitis~     has yet to be proven. This inconsistency is due in part to the lack of sufficiently sensitive~     methods for the evaluation of lung function and thus the response to albuterol in infants.~     Because of the difficulties in evaluating the response to therapy, healthcare providers are~     forced to rely on their physical examination skills or a clinical scoring system, both of~     which are highly subjective in this population. The investigators propose to conduct a~     prospective observational study of healthcare providers to determine the accuracy of clinical~     assessment as compared to that of pulmonary mechanics in a population of children intubated~     and mechanically ventilated for bronchiolitis.~   "
177750|NCT01238432|"~     Near fatal asthma exacerbations are one of the most common causes of critical illness in~     children, accounting for approximately ten thousand intensive care unit (ICU) admissions per~     year in the United States. Even children with intermittent or mild baseline asthma can~     develop these severe exacerbations; however, there are few studies evaluating the risk~     factors associated with the development of near fatal asthma exacerbations in children.~     Inhaled β2-adrenergic receptor (ADRβ2) agonist therapy is the foundation of therapy for acute~     asthma and genetic variations of this receptor have been shown to affect response to ADRβ2~     agonist therapy in this population. The investigators hypothesis is that a child's ADRβ2~     genotype is associated with the development of a near fatal asthma exacerbation.~   "
177751|NCT01238419|"~     The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison~     with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg~     ulcer.~   "
177765|NCT01238237|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic~     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. Initial~     therapy consists of either surgical resection, external beam radiation or both. All patients~     experience a recurrence after first-line therapy, so improvements in both first-line and~     salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is~     unknown if currently used intravenous (IV) therapies even cross the blood brain barrier~     (BBB). Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can~     effectively increase the concentration of drug delivered to the brain while sparing the body~     of systemic side effects. One currently used drug called, Cetuximab (Erbitux) has been shown~     to be active in human brain tumors but its actual CNS penetration is unknown. This phase I~     clinical research trial will test the hypothesis that Cetuximab can be safely used by direct~     intracranial superselective intraarterial infusion up to a dose of 500mg/m2 to ultimately~     enhance survival of patients with relapsed/refractory GBM/AA. By achieving the aims of this~     study the investigators will determine the the toxicity profile and maximum tolerated dose~     (MTD) of SIACI Cetuximab. The investigators expect that this study will provide important~     information regarding the utility of SIACI Cetuximab therapy for malignant glioma, and may~     alter the way these drugs are delivered to the investigators patients in the near future.~   "
177752|NCT01238406|"~     Study design: Multicenter,randomized, prospective, open label, cross over, six segments,~     pilot trial to evaluate blood glucose control overnight under closed-loop insulin delivery~     with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes.~      on the first segment 15 eligible subjects will be enrolled from the three participating~     centers (5 patients at each center). All 15 patients will participate in the overnight closed~     loop session in the hospital settings.~      On the second segment, 54 eligible subjects will be enrolled (18 at each center). Each~     subject will participate in the two consecutive overnight sessions in diabetes camp settings,~     one under closed-loop with MDLAP and one under sensor augmented pump therapy.~      In the third segment,9-20 eligible patients will be enrolled at the Israeli center only.Each~     subject will participate in up to four consecutive overnight under closed loop with MDLAP and~     up to four additional overnight under regular sensor augmented pump therapy at home.~      On the fourth segment, 45-60 patients will be enrolled at the Israeli center only. This~     segment will be conducted at a diabetes camp and will consist of two main parts. In part 1,~     15-20 patients will be randomized to participate in one of the two groups: 2-4 nights under~     closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under~     closed loop control without activating the MD-Logic learning algorithm. In part 2 of the~     forth segment 30-40 patients will participate in two consecutive24-48 hours sessions,one~     under closed loop control and the second under sensor augmented pump therapy.~      On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center only.The~     first 10 patients will participate in a pilot session and data gathered at this pilot session~     will not be used at the final analysis.This segment will consist of two parts. At part 1 each~     subject will participate in 4weeks-1.5 months period of over nights either using closed-loop~     with MDLAP or using sensor augmented pump (SAP) therapy.At the end of the first 4 weeks-1.5~     months of the study, statistical analysis will be performed in order to decide whether to~     extend the study with an optional period of extra 4 weeks-1.5 months.In case it will be~     decided to extend the study, additional 4 weeks-1.5 months intervention period following~     completion of final visit activities will be offered to participants. Subjects that have~     participated in the control group (sensor augmented pump therapy) will be offered the~     opportunity to continue to 4 weeks-1.5 months of closed-loop control and the study group will~     be offered to switch to sensor augmented pump therapy. In segment 5 part 2, up to 40 patients~     will be enrolled. Each patient will participate in 3 months study period either using~     overnight closed loop under MDLAP or sensor augmented pump therapy.Participants in segment 5~     part 2 will be offered to participate in part 2A. At this part, sleep quality assessment will~     be made (by using actigraf and sleep questionnaire) At the end of this period an optional 3~     months extension period will be offered with the other arm (cross-over)~      Segment 6 will be consist of two main parts.In part 1, up to 40 eligible patients will be~     enrolled at the Israeli center only. Each subject will participate in up to 72 hours of~     closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy~     . The sequence of the treatment intervention will be randomly assigned. The sequence of the~     treatment intervention will be randomly assigned. In part 2 of this segment 40 eligible~     patients will enrolled at the Israeli center only. Each subject will participate in up to 2~     weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor augmented pump~     therapy. The sequence of the treatment intervention will be randomly assigned~      Objectives: The objective of this feasibility study is to evaluate the safety and efficacy of~     blood glucose control using the MD-Logic Artificial Pancreas System in individuals with type~     1 diabetes in the hospital settings,at a diabetes camp and finally at patient's home.~   "
177753|NCT01238393|"~     The purpose of this study is to determine whether intraocular injection of ranibizumab~     decreases the retinal thickness in patients with epiretinal membranes and reduces associated~     symptoms.~   "
177754|NCT01238380|"~     Monogenic diabetes is an unusual form of diabetes. It usually presents in patients under the~     age of 30, so is often misdiagnosed as Type 1 diabetes which is more common. Patients with~     monogenic diabetes can often be treated with tablets rather than insulin injections, leading~     to better control of their diabetes, and fewer side-effects and complications. Less than 5%~     of people with monogenic diabetes in the UK have been identified, meaning up to 20,000~     patients may still be misdiagnosed and receiving inappropriate treatment. We want to identify~     the best way of ensuring that people diagnosed with diabetes under the age of 30 have all the~     necessary tests to ensure they have the correct treatment for their particular type of~     diabetes. A small number of people may, as part of this study, be found to have a specific~     genetic cause of their diabetes and in these cases we will measure the success and benefits~     of changing their treatment, usually from insulin injections to sulphonylurea tablets.~   "
177755|NCT01238367|"~     This trial is conducted in Japan. The aim of this clinical trial is to investigate the~     pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog~     alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.~   "
177756|NCT01238354|"~     This study focuses on the difficulties to maintain a weight loss and behavioural change after~     having been in a institutional intermittent weight loss programme.~      We explore if including a member of the family or a close friend in the treatment influences~     weight loss maintenance after completion of the programme.~   "
177757|NCT01238341|"~     In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an~     endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).~   "
177758|NCT01238328|"~     The purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic~     cells using chemotherapy regimen without total-body irradiation in children undergoing a~     hematopoietic stem cell transplant for Mucopolysaccharidosis. The blood stem cells will be~     derived from either related donor or unrelated umbilical cord blood or haploidentical donor.~   "
177759|NCT01238315|"~     The purpose of this Phase Ib study is to determine if Human Central Nervous System Stem~     Cells(HuCNS-SC) is safe to be transplanted in subjects with infantile and late infantile~     neuronal ceroid lipofuscinosis. The study will also measure post-transplantation disease~     progression.~   "
177760|NCT01238302|"~     -  The purpose of this study is to compare the clinical and anatomical outcomes of rotator~          cuff repair with Platelet-Rich Plasma(PRP) and conventional rotator cuff repair in~          treatment of large to massive rotator cuff tears.~        -  PRP application to arthroscopic rotator cuff repair would accelerate recovery after~          arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall~          satisfaction, and enhance structural integrity of repaired tendon.~   "
177761|NCT01238289|"~     The purpose of this study is to evaluate the effect of a culturally sensitive diabetes~     self-management program on glucose control and metabolic parameters in low income~     Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost,~     peer-educator format.~   "
177762|NCT01238276|"~     This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft~     tissue infections. In this study, cefazolin is delivered directly to the target tissues using~     subcutaneous injection of antibiotic solution and then dispersed using high-frequency~     external ultrasound. Using this system, a much higher concentration of antibiotic can be~     achieved than through traditional treatment methods.~      Unlike traditional delivery methods, Direct Antibiotic Delivery does not rely on blood supply~     and is beneficial for subjects with Diabetes or subjects who have received radiation therapy~     and blood supply is limited.~   "
177763|NCT01238263|"~     Recently, IgE-type autoantibodies against self proteins have been detected in the serum of~     the atopic dermatitis patients. The role of this IgE autoantibodies involved in the~     pathogenesis of atopic dermatitis is not known, yet. But, there may be a correlation between~     the severity of the disease and the serum levels of this autoantibodies. The autologous serum~     skin testing is applied to both atopic dermatitis patients and healthy control and the~     results are estimated in this study.The investigators detected 70% positive autologous serum~     skin testing in atopic dermatitis patients and test positivity was higher in patients with~     atopy history, moderately severe disease calculated by SCORAD index and high serum IgE~     levels.~   "
177764|NCT01238250|"~     The Simons Variation in Individuals Project (VIP) is characterizing the medical, behavioral,~     and learning features of individuals with specific documented genetic changes associated with~     features of autism and developmental delay with the goal of improving clinical care and~     treatment for these individuals.~   "
182438|NCT01176851|"~     The purpose of this study is to investigate the pharmacokinetics, the absolute~     bioavailability and the lung bioavailability of inhaled Glyco pMDI.~   "
177766|NCT01238224|"~     An increase of blood flow and capillary permeability decrease the impact of an endothelial~     barrier for glucose and insulin allowing them to reach their target cells in peripheral~     insulin sensitive organ in the human body. It is well known that insulin-resistant type 2~     diabetes patients have an impaired blood flow in skeletal muscle and it is therefore~     important to elucidate means to reverse this metabolic defect.~      The investigators have in a recently published study in type 2 diabetes patients used a drug~     against erectile dysfunction, the PDE-5 inhibitor tadalafil, with known effects on several~     vascular territories, to increase muscle blood flow in type 2 diabetes patients who were~     studied after fasting overnight.~      The aim of this study is to test the hypothesis that tadalafil, compared to placebo,~     increases muscle glucose uptake and lowers blood glucose following a mixed meal served to~     type 2 diabetes patients.~   "
177767|NCT01238211|"~     This phase II trial studies the side effects and how well giving combination chemotherapy~     together with dasatinib works in treating patients with newly diagnosed acute myeloid~     leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work~     in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving~     combination chemotherapy together with dasatinib may kill more cancer cells.~   "
177768|NCT01238185|"~     RATIONALE: Aspirin mouthwash may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of aspirin mouthwash~     in treating patients with oral leukoplakia.~   "
177769|NCT01238172|"~     RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients~     with prostate cancer.~      PURPOSE: This randomized clinical trial is studying how well diet works in altering disease~     progression in patients with prostate cancer on active surveillance.~   "
177770|NCT01238159|"~     The purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed~     by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma.~   "
177771|NCT01238146|"~     This phase I/II trial is studying the side effects and the best dose of obatoclax mesylate~     when given together with rituximab and bendamustine hydrochloride to see how well it works~     compared with rituximab and bendamustine hydrochloride alone in treating patients with~     relapsed or refractory non-Hodgkin lymphoma. Obatoclax mesylate may stop the growth of cancer~     cells by blocking some of the proteins needed for cell growth. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some find cancer cells and help kill~     them or carry cancer-killing substances to them. Others interfere with the ability of cancer~     cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride,~     also work in different ways to stop the growth of cancer cells, either by killing the cells~     or by stopping them from dividing. Giving obatoclax mesylate together with rituximab and~     bendamustine hydrochloride may kill more cancer cells~   "
177772|NCT01238133|"~     This phase I trial studies the side effects and the best dose of gamma-secretase inhibitor~     RO4929097 when given together with paclitaxel and carboplatin in patients with stage II or~     stage III triple-negative breast cancer. Gamma-secretase inhibitor RO4929097 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs use in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving gamma-secretase inhibitor RO4929097 together with paclitaxel and~     carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~   "
177773|NCT01238120|"~     This research seeks to determine if a combination of low-dose ibuprofen along with a~     structured home-based walking and progressive resistance exercise program, EXCAP, will be~     effective in reducing cognitive difficulties among cancer patients receiving chemotherapy.~   "
177774|NCT01238107|"~     A phase II clinical study to evaluate MT-102 administered over a sixteen week period in~     subjects with cachexia related to non-small cell lung cancer and colorectal cancer~   "
177775|NCT01238094|"~     The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs~     XELIRI/FOLFIRI + placebo.~   "
177776|NCT01238081|"~     Respiratory viruses, such as those that cause colds and influenza, are very common in the~     general population. The average adult will experience between 2 and 4 viral respiratory~     illnesses each year. It is known that respiratory viruses can cause flare-ups of chronic lung~     diseases such as asthma and chronic obstructive pulmonary disease. In children with CF,~     respiratory viral infections have been identified in nearly half of all exacerbations and are~     associated with a decline in lung function and increased frequency of hospital admission and~     acquisition of new bacterial pathogens.~      Currently, little is known about the impact of viral infections on the course of CF lung~     disease in adults and no large-scale prospective studies in this area have been performed to~     date. It is unknown how often respiratory viruses can be found in patients with CF when they~     are well and what consequences they have on the course of exacerbations of CF lung disease.~     This study will identify the frequency of common viral infections in adults with CF and~     determine the effects they have on lung function, the rate and diversity of bacterial~     infection and patients' treatment burden. The information gained from this study will lead to~     improved prevention and treatment of respiratory infections in CF.~   "
177777|NCT01238068|"~     The study hypothesis is the the results of the use of Gamma nail will be superior to the use~     of Dynamic hip screw for unstable intertrochantric hip fracture.~   "
177778|NCT01238055|"~     The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the~     treatment of advanced gastric cancer patients who had prior chemotherapy with~     fluoropyrimidine and platinum.~   "
177779|NCT01238042|"~     Patient's with High Grade Dysplasia, Carcinoma in situ or Early Adenocarcinoma in Barrett's~     Esophagus are injected with HPPH and one day later are endoscopically treated with light from~     a laser.~   "
177780|NCT01238029|"~     The purpose of the study is to investigate safety and efficiency of the triple combination of~     capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.~   "
177781|NCT01238016|"~     The trial aims at measuring the safety and performance of the Hyposafe device.~   "
177782|NCT01238003|"~     Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis~     of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients~     the specificity and sensitivity to the ANCA test is very high. This study hopes to prove that~     when this lab test is performed on blood of patients who do not have a high level of~     suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and there~     are many false positive results. Because of this, it should not be used as a screening test~     for a more general patient population.~   "
177783|NCT01237990|"~     This study was designed to confirm that the surgeon is able to perform surface registration~     of standard liver features used as landmarks during a scheduled laparoscopic liver procedure.~     Additionally, registrations will be obtained with full insufflation pressure and with half~     insufflation pressure during the laparoscopic procedure. Under the presence of both~     insufflation pressures, the surface of the liver will be manually swabbed with the study~     tracked laparoscopic probe with landmarks noted during data collection. After registration of~     the liver is obtained, the registration points obtained during this procedure will be~     evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and~     evaluating the location of the tracked laparoscopic probe displayed on the guidance system 3D~     image. The surgeon will accept or reject the registration accuracy. Upon completion of the~     scheduled laparoscopic procedure, the subject will then undergo the open procedure scheduled~     for the surgical case. An open liver registration will be obtained with manual swabbing of~     the liver using the study tracked probe and will be accepted or rejected by the surgeon using~     the process described in the laparoscopic procedure.~      In the event that the disease is determined to be too great for surgical repair during the~     laparoscopic staging procedure, only minimally invasive liver surface data will be acquired~     and the patient will not be included in the overall study population.~   "
177784|NCT01237977|"~     The purpose of this study is to test the hypothesis that the efficacy and safety of~     Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.~   "
177785|NCT01237964|"~     A pilot experiment to test the efficiency of the enzyme Collagenase in treating contractures~     which result's from burn's healing process.~      So far, treatment of choice in patients with burn's created movement limiting contractures,~     concentrated around supportive care. Patients were referred to surgical intervention only if~     necessary. Treatment by injecting an external enzyme is avant-garde and hasn't been done~     under such conditions.~      This study might introduce a new kind of treatment, which can be done in ambulatory~     environment .This type of treatment might significantly improve patients' function and~     quality of life, with no need for a surgical intervention.~   "
177786|NCT01237951|"~     The goal of this clinical research study is to learn if the combination of gemcitabine,~     busulfan, and melphalan, when given before a stem cell transplant, can help to control~     refractory myeloma. The safety of this study treatment will also be studied.~   "
177787|NCT01237938|"~     This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to~     reduce mammographic density in women at high risk for breast cancer.~   "
177788|NCT01237925|"~     Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema,~     itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine~     formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus,~     including the ones caused by sunburn. The aim of the present study is to demonstrate~     non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel)~     with the standard preparation (1% cream) for the relief of sunburn related symptoms and to~     demonstrate the safety of both preparations.~   "
177789|NCT01237912|"~     The current study was designed to determine the exposure of adult smokers and non-smokers to~     cigarette smoke constituents through evaluation of selected biomarkers of exposure.~   "
177790|NCT01237899|"~     The purpose of this study is to investigate the safety and tolerability of LY2623091 after~     multiple oral dosing in healthy men and women of non-childbearing potential. Two cohorts of~     16 subjects will participate in 2 dosing periods. Treatment assignment will be double-blind~     for LY2623091 and placebo(negative control), and open label for eplerenone(positive control).~   "
177791|NCT01237886|"~     Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or~     endotracheal tube or extubation) is critically important, as both prolonged ventilation and~     failed extubation are both associated with harm and risk of death. Our objective is to~     improve the safety of extubation by harnessing hidden information contained in the patterns~     of variation of heart and respiratory rate measured over intervals-in-time. Currently, to~     assess a patient's ability to be extubated, a spontaneous breathing trial (SBT) is routinely~     performed, where the level of ventilator support is reduced, and their response is observed~     in order to help predict if they will tolerate extubation (i.e. complete removal of~     ventilator support). Given that health is associated with a high degree of variation of~     physiologic parameters (e.g. heart and respiratory rate), and illness & stress are associated~     with a loss of variability, the investigators aim to uncover the loss of variation as a~     measure of stress during SBT's. The investigators hypothesize that maintaining stable heart~     rate and respiratory rate variability (HRV and RRV) throughout the SBT will predict~     subsequent successful extubation, and conversely, a reduction in either HRV or RRV manifest~     during a SBT predicts extubation failure. A pilot study has demonstrated feasibility, and~     compelling preliminary results. A website, centralized data storage and analysis, and a~     trans-disciplinary team of scientists are in place to definitively test this novel~     technology. Determination of when to extubate critically ill patients remains a high-stakes~     clinical challenge; and improved prediction of extubation failure has potential to save lives~     and reduce costs in critically ill patients.~   "
177792|NCT01237873|"~     The purpose of this study is to evaluate the long-term safety and tolerability of the~     combination of aliskiren and amlodipine given to patients with essential hypertension. This~     study is being conducted to support registration of the fixed combination of~     aliskiren/amlodipine in the treatment for hypertension in Japan.~   "
177793|NCT01237860|"~     The study is designed to evaluate the safety and efficacy of using the L300 Plus as a~     neuroprosthesis device for walking in patients following an UMN injury or disease. The~     clinical study is proposed to determine the anticipated adverse event rate and treatment~     outcomes at the conclusion of the study.~   "
177794|NCT01237847|"~     This project will test if a phone intervention can improve the medicine-taking behavior of~     teens with IBD. The investigators will study teens who are taking medicine by mouth. The~     investigators will test if two phone calls that help teens solve problems with their IBD~     medicine help to increase how often teens take their medicine. The study will also see if~     there is any extra benefit of more sessions (four compared to two). The investigators will~     ask 90 teens to be in the study. Teens can be in the study if they are 11-18 years old and~     speak English. They must also take an IBD medication by mouth and have a parent who also~     wants to be in the study. Teens who agree to be in the study will fill out forms at the~     beginning (participant week 0), middle (participant week 12), and end of the study~     (participant week 20). After assessment 1, they will be randomly assigned to either receive 2~     phone calls or a wait list group (participant weeks 6-10). After that, they will complete a~     second assessment. After the second assessment, teens who got the 2 phone calls right will be~     re-randomized to two more sessions or no more sessions (participant weeks 14-18). Teens who~     were in the wait list group will get two phone sessions (participant weeks 14-18). After~     that, there will be a final assessment (participant week 20). The investigators expect the~     phone intervention sessions to reduce barriers to medicine taking, improve medicine taking,~     and improve teen quality of life.~   "
177795|NCT01237834|"~     This study will analyze a series of biological and behavioral markers in different~     populations of smokers. The study groups will differ in their cigarette consumption and level~     of nicotine dependence. This analysis will help to identify factors that might be important~     for smoking behavior and nicotine addiction. The results from this study will contribute to~     improve campaigns for smoking prevention and treatments for smoking cessation.~   "
177796|NCT01237821|"~     This research is being done to find out the safety and efficacy of two acne creams, Effaclar~     and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA~     approved for the treatment of acne.~   "
177797|NCT01237808|"~     This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients~     with AML and NPM1 mutation ineligible for intensive chemotherapy.~      Sample size: 144 patients~      Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are~     expected to be included into the trial)~      Estimated treatment duration of an individual patient: 8 months (Follow-Up period per patient~     will last additional 2 years)~   "
177798|NCT01237795|"~     This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture~     biofilm. Complete denture wearers will be instructed to brush their dentures with a specific~     toothbrush and four compositions: (1) A proprietary denture-specific paste (active~     comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each~     treatment will be used for periods of 7 days, and participants will be randomized to use them~     according to one of four sequences.~   "
177799|NCT01237782|"~     The purpose of this study is to assess if a propolis solution is able to remove plaque and~     kill microbes from complete dentures. The investigators will compare the results of the~     propolis-based denture cleanser with those obtained with an inactive solution.~   "
177800|NCT01237769|"~     In recent years emphasis has been given to investigate the role of vitamin D in areas beyond~     bone metabolism and maintenance of calcium homeostasis. Thus, vitamin D deficiency has been~     associated with risk factors for the occurrence of cardiovascular disease as well as with~     overall mortality.In addition, there are indications that a large proportion of the~     population (up to 50%) is vitamin D deficient. The measurement of vitamin 25 (OH) D3 levels~     is the best way to estimate the vitamin D actual reserves. It is worth mentioning that~     elevated levels of parathyroid hormone (PTH) [5] and reduced levels of 1,25 (OH)2 vitamin D3~     (calcitriol have also been associated with cardiovascular disease.~      The metabolic syndrome is a sum of risk factors for cardiovascular disease and is found in~     approximately 25% of the Greek population.There are a lot of data linking low vitamin D~     levels with the metabolic syndrome as a whole as well as with its individual characteristics.~     Specifically, vitamin D deficiency has been associated with increased incidence of~     hypertension, dyslipidemia, obesity, inflammation and dysglycemia.~      Many studies have explored the effect of giving vitamin D supplements on the risk factors~     associated with the metabolic syndrome and the cardiovascular disease. The results of these~     studies are conflicting and this may partially be due to different doses of vitamin D used.~     The form of vitamin D most commonly used in these studies is cholecalciferol (vitamin D3.~      Aim of the study:~      Determination of the effect of cholecalciferol (VitD3) (2200 IU/day) on metabolic parameters~     in patients with metabolic syndrome.~      Endpoints:~      The primary endpoint will be changes in metabolic syndrome parameters 3 months after starting~     treatment:~        -  Waist circumference~        -  Blood pressure~        -  Levels of fasting serum triglycerides~        -  Levels of high-density lipoprotein cholesterol (HDL-C)~        -  Levels of fasting serum glucose.~      The secondary endpoints will include changes in:~        -  The levels of low-density lipoprotein cholesterol (LDL-C) and non-HDL-C~        -  Subfractions of LDL-C [average particle size of LDL-C, levels of small dense (sd) LDL-C]~        -  Subfractions of HDL-C (levels of small and large particle HDL-C)~        -  The activity and levels of Lp-PLA2 (lipoprotein-associated phospholipase A2)~        -  The levels of serum apolipoprotein AI, A-II, AV, B, E, C-II, C-III and lipoprotein (Lp)~          (a)~        -  The activity of paraoxonase-1 (PON1)~        -  The concentration of pre-beta1-HDL~        -  The levels of hs-CRP (high sensitivity C-reactive protein)~        -  Oxidative stress as measured by levels of 8-isoprostane in the blood and urine and~          oxidized LDL (oxLDL)~        -  Adipokine levels (leptin, adiponectin, visfatin)~        -  Glucose homeostasis (index HOMA: fasting insulin X fasting glucose/405)~        -  The levels of glycosylated hemoglobin (HbA1c)~        -  The levels of 25 (OH) vitamin D3, of 1,25 (OH)2 vitamin D3 and PTH~        -  The levels of serum electrolytes (Ca, PO4) and the activity of alkaline phosphatase~          (ALP) in serum.~      Study population:~      The investigators will study patients with metabolic syndrome (n = 50 adults) attending the~     Outpatient Lipid and Obesity clinic at the University Hospital of Ioannina. Diagnosis of the~     Metabolic Syndrome will be based on the criteria of National Cholesterol Education Program~     Adult Treatment Panel III (NCEP-ATP III).~      All patients will be instructed to exercise and lose weight according to the NCEP-ATP III~     diet. The participants will be randomized in an open manner into one of the following 2~     treatment groups: a) cholecalciferol (VitD3) (2200 IU/day) plus lifestyle measures or b) only~     lifestyle measures. Recruitment will be completed within one year. The reassessment of the~     patients will be done 3 months after starting of treatment.~   "
177801|NCT01237756|"~     Endobronchial tube misplacement is serious complication during general anesthesia in~     pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is~     crucial. Several methods have been suggested for determination of correct ETT placement.~     However, to date, auscultation of the left and right lung is the standard of care and the~     only ubiquitary available method with an error rate of up to 12%. Electrical impedance~     tomography (EIT) is a new non-invasive method for evaluation of left and right lung~     ventilation. In this study the investigators investigate the potential role of EIT for proper~     placement of pediatric endotracheal tubes.~   "
177802|NCT01237743|"~     Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for~     definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate.~     By avoiding the effects of cardiopulmonary bypass on cerebral hemodynamics and microembolic~     load, TAVI is assumed to be beneficial regarding risk for neurological complications. We~     anticipated that the extensive endovascular retrograde manipulation in ascending aorta and~     aortic root would generate a detectable cerebral microembolic load, and thus an increase in~     serological markers of neuronal injury postoperatively. Our hypothesis is that there is a~     positive correlation between the total amount of cerebral microembolic events during the TAVI~     procedure and the Area under curve (AUC24hrs) for the release pattern of two markers of~     neuronal injury. We also wish to describe the extent and distribution of microembolisms~     during the TAVI procedure using Transcranial Doppler (TCD).~   "
177803|NCT01237730|"~     Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce~     the peristomal infection rate~   "
177804|NCT01237717|"~     One interesting area is the relationship of high salt intake and central aortic blood~     pressure. High salt intake is associated development of hypertension and cardiovascular~     mortality. Central aortic pressure is better correlated with cardiovascular events and~     mortality. With recent advances in technology, it is possible to measure central aortic~     pressure noninvasively and easily. Until now there is no study to evaluate the relationship~     of high salt intake and aortic blood pressure.~      The purpose of the present study is to evaluate the relationship of high salt intake and~     aortic blood pressure and aortic stiffness.~      Subjects with or without hypertension will be enrolled for investigation. Subjects with~     hypertension should be never treated with antihypertensive medications. Subjects with~     secondary hypertension, diabetes, heart failure, high grade kidney disease, ischemic heart~     disease, and major arrhythmia will be excluded.~      Sodium intake is measured by 24 hour urinary sodium excretion, with the measurement of~     peripheral and central aortic blood pressure, and aortic pulse wave velocity.~      Salt sensitive hypertension related single nucleotide polymorphism will be analyzed to define~     the relationship with high salt intake and aortic pressure and pulse wave velocity.~   "
177825|NCT01237444|"~     The purpose of this study is designed to compare the safety, tolerability, antiviral activity~     and immunological effect of lopinavir/ritonavir plus lamivudine (3TC) versus standard therapy~     with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus~     lopinavir/ritonavir in the treatment of naïve HIV-1 infected subjects.~   "
178821|NCT01224366|"~     To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients~     with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.~   "
177805|NCT01237704|"~     In Hong Kong, every 30 and 12.9 in 100,000 males and females respectively has nasopharyngeal~     carcinoma (NPC). With early detection and advances in medical care, the number of NPC~     survivors post radiotherapy is rapidly growing in Hong Kong. One of the most distressing~     consequences post radiotherapy for NPC patients is swallowing disorder, or dysphagia.~     Dysphagia in NPC patients almost certainly cause frequent chest infection, dehydration,~     malnutrition and limitations to concurrent treatment such as oral medication. Given the~     existing large costs NPC patients incur to the healthcare system, dysphagia only serves to~     further inflate the soaring costs.~      In an attempt to reduce dysphagia related costs to the healthcare system, swallowing~     rehabilitation is offered to NPC patients. Currently, two major swallowing rehabilitation~     approaches are commonly adopted. The first is traditional rehabilitation, which involves~     patients performing various oropharyngeal exercises aimed at improving swallowing physiology.~     The other swallowing rehabilitation approach is transcutaneous electrical stimulation, which~     entails using small amount of electric current to increase muscle strength while patients are~     engaged in swallowing activities. These two methods are proven as effective in patients with~     stroke and head and neck carcinoma patients. Neither of these methods, nevertheless, yields~     any efficacy studies in treating NPC patients. Yet, clinicians continue to use either one or~     both rehabilitation methods as swallowing rehabilitation.~      This study aims to address the gap in efficacy studies on swallowing rehabilitation for NPC~     patients post radiotherapy. The research results should provide justification for~     rehabilitation time, clinicians' efforts, costs involved and resources used in rehabilitating~     the swallowing difficulties of the NPC patients.~   "
177806|NCT01237691|"~     The phase I evaluation is intended to assess whether or not frequent drug testing and~     immediate short-term incarceration for drug use and/or other violations and mandated drug~     treatment for multiple violations, reduces the recurrence of drug use and/or other violation~     behaviors by California parolees assigned to the study group.~   "
177807|NCT01237678|"~     The purpose of this study is to test safety and efficacy of this combination treatment~     (IMGN901, carboplatin and etoposide) in patients with solid tumors and extensive stage small~     cell lung cancer.~   "
177808|NCT01237665|"~     This is a prospective open label single-arm, single-institution phase II clinical trial to~     test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine [Xeloda],~     Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable~     non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.~   "
177809|NCT01237652|"~     During or after surgery, patients may suffer heart attacks or other heart complications,~     increasing the hospital stay by 11 days on average and costing an estimated US$20 billion in~     1990.Many risk factors have been identified but there are no properly conducted studies to~     look at Blood pressure (BP) as a risk factor around the time of surgery. The investigators~     believe there is a good possibility that systolic BP (SBP) is a risk factor but currently~     unrecognized. When measuring BP, two numbers are obtained. The upper number is called SBP and~     a lower number called diastolic BP (DBP). If the numbers are high, this means that the~     patient has a high BP or hypertension. If the SBP is high while DBP is normal, it is called~     isolated systolic hypertension (ISH)> ISH is increasingly recognized as a major risk factor~     for heart problems. The relationship between ISH and heart complications around the time of~     surgery is poorly understood. Previous studies did not look at such a relationship. Because~     of that, there are no guidelines for ISH management at the time of surgery. Generally, these~     patients go through surgery as if they have no increased risk. Studies are starting to show~     that the bulk of these heart complications happen in patients thought to have low risk~     factors not yet identified, including ISH.~      The investigators believe that the oxygen supply to the heart can be compromised around the~     time of surgery in ISH patients Chemicals known as stress hormones are secreted around the~     time of surgery, increasing oxygen needs in the heart and may make the oxygen supply to the~     heart muscle critical (know as myocardial ischemia). This in turn may result in a heart~     attack and death. Studies have shown that patients with myocardial ischemia stand a 9-fold~     increase in odds ratio of suffering a heart attack, worsening of angina, or death.~      This study aims to compare the incidence of myocardial ischemia in patients with ISH and~     normal BP patients around the time of surgery using a special heart monitor. In addition, the~     study aims to determine the prevalence of ISH among surgical patients and to document~     complications like heart attacks, heart failure, stroke and death after surgery.~      This research project will be conducted at the Ottawa Hospital by a multi-disciplinary~     research group (perioperative research group)which includes anesthesiology, cardiology,~     general surgery and epidemiology. The research group secured HSFO funding for this study.~   "
177810|NCT01237639|"~     Transfusion of red blood cells (RBCs) is important for the care of patients undergoing stem~     cell transplantation. Stem cell transplants are used to treat blood cancers and bone marrow~     disorders. This involves the use of high doses of chemotherapy and/or radiation to kill~     cancer cells; but this damages the marrow and blood system. Blood stem cells are transplanted~     by infusing into the recipient and blood counts recover over 2-3 weeks. Before bone marrow~     recovery, RBCs are needed to support the patient. Higher hemoglobin in these high risk~     patients may have benefits such as better energy and organ function. However, research in~     other areas of medicine suggests that a higher red cell count may be dangerous. Taken~     together, it is unclear whether having a lower or higher red cell count is better for~     patients having a blood stem cell transplant. The investigators plan to study this by~     randomly assigning patients having a transplant to be transfused with RBCs either at a higher~     or lower hemoglobin level. In this way, the investigators will be able to accurately find out~     if there are any benefits or harms in having a lower or higher red cell count during the~     recovery period after blood stem cell transplantation.~   "
177811|NCT01237626|"~     The following study is designed in order to effectively collaborate and coordinate~     information amongst colleagues to advance knowledge on information related to older drivers.~     Candrive is dedicated to improving the safety and quality of life of older drivers. The major~     objective is to develop a valid, easy to use in office screening tool that will help~     clinicians identify older drivers who need further assessment of their driving. Over the~     course of the study, the goal will be to provide enough data to establish findings relating~     to knowledge generation, translation of research into action, training and sustainability. It~     is our hope that the research process will translate to help increase the knowledge of public~     policy makers, clinicians and the general public. A 5 year study will create an opportunity~     to document the natural course of an older adult's driving patterns up until driving~     cessation. This will not only provide data for road safety but also help understand the~     psychosocial factors leading to driving cessation. The data relating to psychosocial factors~     may also lead the way in establishing ways of extending the safe driving period for older~     adults.~      The investigators hypothesize that the knowledge derived from this interdisciplinary research~     will be used by transportation policy makers, clinicians, and general public to improve~     safety and quality of life for older drivers.~   "
177812|NCT01237613|"~     The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue~     Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with~     regard to lower leg and foot function, pain and quality of life.~   "
177813|NCT01237600|"~     The purpose of this study is to elucidate the appropriate condition of developing cultivated~     corneal epithelial graft and evaluate the surgical outcome of transplantation of the~     cultivated corneal epithelial stem cell in the patients.~   "
177814|NCT01237587|"~     The purpose of this study is to determine whether duloxetine is safe and effective in the~     treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).~      This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and~     an open label extension period of 26 weeks.~   "
177815|NCT01237574|"~     Chronic alcoholic and metabolic liver diseases are the two main liver diseases in France. The~     long-term prognosis of these two diseases are not well known because main studies are~     retrospective and with only alcoholic patients. The knowledge of the natural history of these~     diseases should improve the management of patients with such diseases.~      The aim of this prospective cohort is to describe the natural history of patients with~     chronic liver disease due to alcohol or metabolic disease and to identify factors associated~     with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites.~     ..).~   "
177816|NCT01237561|"~     This project will evaluate the translation of the Gold (the Global Strategy for the~     Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) COPD~     guidelines into primary care practice. During phase I, a needs assessment will evaluate~     barriers and facilitators to implementation of COPD guidelines into clinical practice through~     focus groups of primary care patients and providers. Using formative evaluation and feedback~     from the focus groups, three tools will be developed, refined and pilot tested. The~     effectiveness of the materials developed in phase I will be tested in phase II (a randomized~     clinical trial conducted with one year of intervention within non-academic primary care~     practices) regarding physician performance of COPD guideline implementation and improvement~     in the clinically relevant outcomes (appropriate screening, diagnosis and management of COPD)~     compared to usual care.~   "
177817|NCT01237548|"~     Title: The acute effect of narghile smoking on endothelial Function, and exhaled breath~     condensate (EBC) and pulmonary function tests in healthy volunteers.~      Objectives: To evaluate the acute effect of one cession of narghile smoking on endothelial~     Function, airway inflammation as assessed by exhaled breath condensate (EBC) in healthy~     volunteers.~      Design: Prospective study evaluating these parameters before and after 30 minutes of Narghile~     smoking. The changes in inflammatory parameters pre and post smoking will be evaluated~     blindly.~      Sample size: 50 participants Participant selection: Adults subjects who smoke Narghile .~     Intervention: Each subject will undergo evaluation including a respiratory questionnaire,~     endothelial Function , pulmonary function tests , exhaled breath condensate (EBC) and~     carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession~     of 30 minutes narghile smoking.~   "
177818|NCT01237535|"~     This is a single center, 3 arms, prospective randomized controlled open study to determine~     the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles~     with recombinant FSH in patients with unexplained infertility and mild male factor.~      Patients will be randomized into 3 groups:~        1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8%~          vaginal gel; Serono, Israel)~        2. Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel)~          and Estrofem 4mg].~        3. No luteal support~   "
177819|NCT01237522|"~     The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians~     volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that~     renal clearance of metformin is affected in Caucasian with the known single nucleotide~     polymorphisms A270S in OCT2.~   "
177820|NCT01237509|"~     Hypoglycaemia is associated with characteristic changes in the EEG with the appearance of~     slow frequency waves. In a recent study the investigators have shown that these changes can~     be recorded from subcutaneous electrodes and processed by an automated mathematical algorithm~     based on non-linear spectral analysis, and that changes are present before the occurrence of~     severe hypoglycaemia in type 1 diabetes patients. An alarm device based on real-time analysis~     of continuous EEG-recordings may thus be possible. For many diabetes patients nocturnal~     hypoglycaemia is a feared complication which may thus be preventable.~   "
177821|NCT01237496|"~     This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B~     treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in~     study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample collection~     period for each patients will occur in the first 24 weeks.~   "
177822|NCT01237483|"~     The purpose of this study is to investigate in patients with cancer of the throat and~     recurrent inoperable a different modality treatment consisting of radiation continuously for~     5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer,~     called Erbitux ®.~      The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment)~     to improve the antitumor efficacy without additional toxic side effects.~   "
177823|NCT01237470|"~     Contemporary treatment of inguinal hernia is generally based on surgical methods with the use~     of synthetic meshes. The implanted meshes however have some disadvantages: they increase the~     risk of infection, tend to sustain inflammation process, can generate chronic pain and~     fertility disorders, can move from the initial implantation site, increase costs of treatment~     etc. The research to find any new hernioplasty without the use of meshes is still going on.~      Desarda in 2002 year published his own results over hernia treatment with the use of external~     oblique aponeurosis. These results were comparable with the effects of Lichtenstein~     technique.~      The initial assessment done in our own department revealed good clinical results after hernia~     treatment with Desarda's method.~      To make appropriate and objective clinical assessment of the Desarda's technique for primary~     inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was~     projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in~     the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.~      Generally no statistically significant differences were found between these groups. The only~     difference was higher rate of seroma after Lichtenstein technique and different pain~     perception in both groups. To the summary it is clear that Desarda technique is quite~     attractive and good proposition for operative hernia treatment without mesh. The RCT was done~     with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for~     clinical trials.~   "
177824|NCT01237457|"~     This is a phase II treatment protocol offering 177Lu-DOTATATE therapy for somatostatin~     receptor expressing cancers including, but not limited to, those arising from the neural~     crest and involving such organs as the lungs, breast, gastrointestinal tract, skin and~     endocrine (examples: pheochromocytoma, medullary carcinoma of the thyroid, non radioiodine~     avid differentiated thyroid cancer, melanoma, renal cell, Merkel cell, paraganglioma, small~     cell lung, Carcinoid and pancreatic islet cell malignancies).~   "
177826|NCT01237431|"~     In patients with autonomic dysfunction water drinking elicits a pressor response mediated by~     sympathetic activation. If any, in healthy subjects there is only a slight increase in blood~     pressure. However, the sympathetic activation is observable by resting energy expenditure~     increases greater than 20%.~      The investigators believe that the response to water may be mediated through sympathetic~     activation elicited by osmosensitve spinal afferents in the liver. Therefore, the~     investigators want to test water in liver transplant patients who have a denervated liver.~     Kidney transplant patients serve as control subjects. The investigators hypothesize that the~     increase in norepinephrine after water drinking is blunted in liver transplant recipients.~   "
177827|NCT01237418|"~     The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited~     prospectively over a period of 2 months.~      Patients will be followed up at 1 month and then followed annually for 10 years.~      Patients should have agreed to participate in the study, participation in the protocol, or~     refusal to participate will not affect the therapeutic approach of the physician. The study~     of genotypic or phenotypic characteristics will not change the therapeutic approach of health~     care teams.~   "
177828|NCT01237405|"~     The purpose of this study is to evaluate 99mTc - EC20 imaging (FolateScan), a Nuclear~     Medicine imaging technology that enables localization of activated macrophages in the joints~     of participants with knee osteoarthritis (OA). Twenty five participants with symptomatic~     unilateral or bilateral knee OA will undergo a one-time evaluation of the knee as follows:~     knee radiography, FolateScan of the knees and whole body, musculoskeletal exam,~     questionnaires, sampling of blood, urine and synovial fluid for analysis of inflammatory~     markers. Data analysis will be cross-sectional and include a comparison of the location and~     intensity of EC20 uptake with the following: radiographic knee OA severity, clinical measures~     of disease severity, cytokine expression, and synovial fluid cell count.~   "
177829|NCT01237392|"~     A single center, randomized, parallel, clinical outcome trial to compare the rate of healing~     in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation)~     or standard of care sharp debridement.~   "
177830|NCT01237379|"~     The purpose of this study is to screen for peroxisome defects in child and adolescent~     offspring of Bipolar Disorder I (BD-I) parents at different stages of risk for transitioning~     to mania and following the onset of mania.~      Prediction 1: Youth with an elevated risk for developing BD-I and first-episode manic~     patients will exhibit graded deficits in measures of peroxisomal function compared with~     healthy controls.~      Prediction 2: Indices of peroxisomal function will be correlated with Red Blood Cells~     Docosahexaenoic acid (DHA) composition.~      Prediction 3: Graded deficits in measures of peroxisomal function will be inversely~     correlated with manic and depression symptom severity scores.~   "
177831|NCT01237366|"~     This Phase Ib pilot RCT will examine the safety, feasibility, and acceptability of a~     multi-component intervention to address traumatic stress symptoms among HIV-positive,~     methamphetamine-using men who have sex with men (MSM). Following a baseline assessment, 56~     participants will be randomized to receive either: 1) a 7-session intervention to address~     traumatic stress related to living with HIV/AIDS; or 2) a 7-session, attention-control~     condition. Follow-up assessments will be administered at 1 and 3 months post-randomization.~   "
177832|NCT01237353|"~     In this study the investigators will test a nutritional supplement called betaine~     hydrochloride to see if it can temporarily increase the stomach acid in healthy volunteers~     who have decreased stomach acid because they take a medicine called rabeprazole.~   "
177833|NCT01237340|"~     To assess the immunogenicity of Saizen® solution for injection in adult subjects with~     documented Growth Hormone Deficiency (GHD).~   "
177834|NCT01237327|"~     Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women~     with natural or induced postmenopausal status with advanced breast cancer whose disease has~     progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had~     participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.~   "
177835|NCT01237314|"~     This study will record the impact of food on blood glucose levels using continuous glucose~     monitoring (CGM).~      The investigators think the impact will improve as medication doses are adjusted. The~     investigators also think that the impact will differ depending on the type of medication~     taken.~   "
177836|NCT01237301|"~     The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions~     related to the management of type 2 diabetes. The secondary objective is to determine the~     benefit of using CGM for clinical diabetes management decision-making.~   "
177837|NCT01237288|"~     The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521)~     in subjects with primary hypophosphatemic rickets.~   "
177838|NCT01237275|"~     First, the investigators examined the functional relevance of serotonin transporter~     polymorphisms by quantifying the activity of serotonin transporter in blood platelets of~     genotyped healthy volunteers and patients with major depression.~      Second, the investigators studied response to SSRIs in relation to 5-HTTLPR genotype and also~     to the functional expression of 5-HTT in platelets.~   "
177839|NCT01237262|"~     The efficacy of TNF alfa inhibitors in the treatment of psoriasis has been documented in many~     studies.~      Their effect on dendritic cells has been scarcely studied. TNF- α has a central role in~     dendritic cell biology, both for their maturity and mobilization of peripheral tissues to~     secondary lymphoid organs.~      The primary objectives of this study are:~        -  To document absolute number, density of immune infiltrate and dendritic cells and~          inflammatory cytokines expression pattern (particularly IFN α and IL-32) in psoriasic~          lesions vs normal skin of the same patient~        -  To describe changes in such cell numbers and expression patterns upon 16 weeks treatment~          with TNF alfa inhibitors.~   "
177862|NCT01236963|"~     It is difficult to obtain patient's compliance with regular interproximal dental hygiene.~     Dental floss is recognized as an effective procedure to remove dental plaque and prevent~     gingivitis in the space between teeth, but it is difficult to use and most patients do no do~     it regularly. Essential oils mouthrinse acts on dental plaque bacteria and helps on~     gingivitis prevention. These properties may be of interest to control dental plaque~     accumulation and gingivitis in interproximal areas. The study hypothesis states that there~     are no differences between the use of an essential oils mouthrinse and dental floss on the~     reduction of dental plaque accumulation and gingivitis.~   "
177840|NCT01237249|"~     This is a national, multicenter, open-label, randomized, comparative study designed to~     compare, first, the TTP of the two treatment schemes proposed (MPV followed by Rd or MPV~     alternating with Rd) in newly diagnosed MM patients older than 65 years. This comparison will~     be performing in terms of both efficacy and safety. Up to 120 patients will be included in~     each treatment arm and evaluated at scheduled visits in up to 3 study periods: Pre-treatment,~     Treatment and Follow-up.~      Primary outcome measure:~        -  To evaluate the efficacy in terms of time to progression (TTP) at 18 months of MPV and~          Rd used as either in a sequential or alternating approach in newly diagnosed MM patients~          older than 65 years.~        -  To evaluate the toxicity (safety and tolerability) of the sequential versus the~          alternating use of MPV and Rd.~      Secondary outcome measure:~        -  To evaluate the response, duration of response, progression free survival (PFS), time to~          next therapy (TNT) and overall survival (OS) in the two different groups of patients.~        -  To identify, within the group of patients treated with the alternating scheme, the~          biological characteristics (including a comprehensive genomic analysis) of those~          patients resistant to one or the other, and patients refractory to both treatments~   "
177841|NCT01237236|"~     LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6.~     CDK4/6 is involved in the process that allows both normal and cancer cells to divide and~     multiply. Cancer cells are often driven to divide and multiply by abnormalities that increase~     the activity of CDK4. Hence there is hope that blocking the activity of CDK4 may slow the~     growth of some cancers. LEE011 has shown anti-cancer activity in several different tumor~     models in animals.~      Because CDK4 is important in both normal and cancerous cells, LEE011 is expected to decrease~     the ability of the bone marrow to make white blood cells, platelets, and red blood cells.~     Although these effects are expected to be reversible, they can increase the risk of~     infection, bleeding and fatigue.~      The primary purpose of this study is to find the highest dose of LEE011 that can be safely~     given to adult patients with advanced solid tumors or lymphomas for which no further~     effective standard treatment is available. It will provide information about the side effects~     that may occur following treatment. The study will also possibly provide early evidence for~     LEE011's anti-tumor activity.~   "
177842|NCT01237223|"~     The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and~     safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with~     essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥ 95 mmHg and < 110~     mmHg and mean sitting systolic blood pressure [msSBP] ≥ 140 mmHg ). This study was conducted~     to support registration of the fixed-dose combination of aliskiren and amlodipine for the~     treatment of hypertension in Japan.~   "
177843|NCT01237210|"~     This study is looking for healthy controls and patients with Parkinson's (PD) to perform an~     MR scan.~        1. The neurochemical profile of the SN of patients with PD as measured by high field MRS~          will differ from that of healthy controls, in that glutathione will be lower due to~          oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis~          markers myo-inositol and glutamine will be higher due to inflammation (glial activation)~          and N-acetylaspartate and glutamate will be lower due to neuronal loss/damage.~        2. There will be a relationship between neurochemical changes and disease severity.~   "
177844|NCT01237197|"~     Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated~     with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM).~     Obesity tracks strongly into adulthood and interventions early in life may reduce risk for~     developing cardiovascular disease and type 2 diabetes. Few drug therapies for weight loss~     have been evaluated in adolescents. Since exenatide is associated with weight loss and~     improves risk factors for cardiovascular disease and type 2 diabetes in adults, it may be~     useful in extremely obese youth. Our primary objective in this study is to generate~     preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve risk~     factors for cardiovascular disease and type 2 diabetes in 26 extremely obese adolescents (age~     12-19 years) in a three-month, randomized, double-blind, placebo-controlled pilot clinical~     trial. GLP-1 therapy has never been evaluated as a treatment for pediatric obesity and is an~     innovative approach to a challenging and significant health care problem.~   "
177845|NCT01237184|"~     The primary purpose of this study is to~        1. determine whether dental implant engaging both the alveolar crest cortical bone and~          sinus floor using vertical stopper drill and self-threading concept (bi-cortical~          fixation) increases initial implant stability compared to the short implants engaging~          only alveolar crest cortical bone (uni-cortical fixation) and/or ones engaging both~          crest and sinus floor but with green stick fracture (indirect sinus lift technique),~        2. study whether different surgical techniques, residual bone height, bone density, and~          length and width of the implants used affect initial implant stability in posterior~          maxilla. In addition, this study will continue to~        3. compare secondary implant stability of implants fixed bi-cortically, uni-cortically and~          with indirect sinus lift technique at 2nd stage surgery/6 month healing and 1 year~          follow-up from the restoration and~        4. measure amount of endo-sinus bone formation from the 1- year follow up CT (computer~          tomogram) scan and evaluate safety and potential post-operative complications of~          bi-cortical fixation and indirect sinus lift technique reported throughout the follow up~          periods.~   "
177846|NCT01237171|"~     For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is~     usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of~     lung may leave too little lung behind for easy breathing. For some of these patients, it may~     be possible to perform a smaller-scale surgery (sub-lobar resection) and place a~     radioactive implant behind to prevent the cancer from growing back. This study will see how~     these patients do in terms of controlling their disease treated with a radioactive implant~     called Cesium-131.~   "
177863|NCT01236950|"~     The use of mouthrinses may be of relevance as a complement to daily dental hygiene~     procedures, especially for patients who do not comply with a proper mechanical removal of~     dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental~     plaque accumulation and gingivitis. Also an effect on dental bacteria can be found. The study~     hypothesis states that there are no differences between the mouthrinses on the reduction of~     gingivitis and dental plaque accumulation as well on the bacterial counts of Streptococcus~     mutans, Lactobacillus, aerobic and anaerobic bacteria.~   "
177847|NCT01237158|"~     Background: The pathophysiological mechanisms of bipolar disorder are not completely~     clarified and several hypothesis have already been formulated including the role of~     monoamines, gama amino butyric acid (GABA) and glutamate. GABA is the main inhibitory~     neurotransmitter while glutamate is the main excitatory neurotransmitter. Genes that play a~     role in GABA metabolism and in the activity of GABA neurons are very important to understand~     the GABA function, once they affect neurodevelopment and its dysfunctions may predispose to~     neuropsychiatric diseases. The two genes that are going to be study in this project are~     glutamic acid decarboxylase (GAD1) and reelin (Reln). The enzyme glutamic acid descarboxylase~     (GAD67) metabolizes glutamate in GABA in the pre synaptic neuronal regions and is coded by~     the gene GAD1. Reelin is secretory serine protease with dual roles in mammalian brain:~     embryologically, it guides neurons and radial glial cells to their corrected positions in the~     developing brain; in adult brain, Reelin is involved in a signaling pathway which underlies~     neurotransmission, memory formation and synaptic plasticity. Magnetic resonance spectroscopy~     (MRS) studies on bipolar disorder show a number of alterations in cerebral level of GABA and~     glutamate in different cerebral areas when compared to healthy subjects and other mood~     disorders. Objective: Investigate in bipolar patients and healthy controls the association of~     GAD1 and Reln single nucleotide polymorphisms(SNP) and cerebral levels of GABA/glutamate on~     MRS. Methods: 70 symptomatic bipolar I patients medication free and 70 healthy controls are~     going to be genotyped for GAD1 and Reln SNPs and GABA/glutamate MRS.~      Key words: GAD1, GAD67, bipolar, GABA, Glutamate, Reelin, Rln, Spectroscopy.~   "
177848|NCT01237145|"~     The purpose of this study is to establish if cells present in lung tissue during extrinsic~     allergic alveolitis (EAA) are able to elicit an immune response against specific antigens.~     The hypothesis is: cells in BAL lavage fluid from patients with EAA will be responsive to~     specific antigens and this response can be measured using ELISPOT.~   "
177849|NCT01237132|"~     The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and~     European Associations for the Study of Liver Disease are based on the~     Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in~     patients with large, multinodular and macrovascular invasive disease. The aim of this study~     was to investigate the role of hepatic resection in a large retrospective multicentric cohort~     of patients resected for HCC regardless of the BCLC indications.~   "
177850|NCT01237119|"~     The purpose of this study is to investigate whether 48 weeks treatment with once-daily~     injections of liraglutide improves liver disease (liver fat, inflammation and scarring) and~     related metabolic parameters in overweight patients with nonalcoholic steatohepatitis, enough~     to warrant further investigation.~   "
177851|NCT01237106|"~     This pilot study will be a prospective investigation to study the efficacy and safety of~     In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10~     subjects total in this Study. There will be no blinding to treatment.~      In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting~     pregnancy through the use of Assisted Reproductive Technology (ART).~   "
177852|NCT01237093|"~     Background:~      - Researchers who study health and nutrition are interested in developing more accurate~     methods of determining what people eat from day to day and how it affects their general~     health. In particular, better methods are needed to determine if people are accurately~     remembering what they ate. One possible method involves the use of biomarkers, or indicators~     in urine, blood, saliva, fat, and hair, which are related to the intake of a particular food~     in a consistent way. One set of biomarkers in blood samples and hair may be used to determine~     the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. However,~     more research is needed to study the effectiveness of using these biomarkers to accurately~     track dietary intake.~      Objectives:~      - To validate the use of biomarkers as representative of specific dietary intake patterns~     (meat/fish/soda).~      Eligibility:~      - Healthy, nondiabetic men between 18 and 65 years of age.~      Design:~        -  This study involves an initial screening visit and a 12-13 week inpatient dietary study~          period.~        -  Participants will be screened with a medical history and physical examination, as well~          as blood and urine samples and a glucose tolerance test to exclude individuals who have~          diabetes.~        -  After 3 days of a standard weight-maintaining diet, participants will have a glucose~          tolerance test and a body fat scan; provide hair, blood, and fat tissue samples; and~          complete questionnaires and performance tests.~        -  Participants will spend one day in a metabolic chamber to measure their energy~          expenditure and general metabolism.~        -  Participants will then be randomized into one of eight carefully designed diets for 12~          weeks. The diets will differ in the amount of meat, fish, and soda, including one diet~          where none of the three biomarker-related foods will be permitted. Blood samples will be~          collected throughout the study diet period.~        -  At the end of the 12-week study diet period, participants will provide additional hair,~          blood, and fat tissue samples, and will have a second metabolism assessment in the~          metabolic chamber....~   "
177853|NCT01237080|"~     The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation~     of morbidly obese. Mainly we will try to clarify which of the instruments that produce the~     shortest intubationtime and lowest number of intubationattempts.~      The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of~     attempts, using the GlideScope®.~   "
177854|NCT01237067|"~     Background:~      - Olaparib is an experimental anti-cancer drug that is part of a class of drugs called PARP~     inhibitors. PARP is a protein that is involved in repairing DNA damage, but it may also~     encourage precancerous cells to develop into cancer cells. Olaparib has been given safely in~     combination with carboplatin, a drug used to treat breast, ovarian, uterine, and cervical~     cancer, but more research is needed to determine whether the drugs are more effective when~     given together or which drug should be given first.~      Objectives:~      - To determine the safety and effectiveness of combined carboplatin and olaparib as a~     treatment for gynecologic (female organ) or breast cancer.~      Eligibility:~        -  Women at least 18 years of age who have breast, ovarian, uterine, or cervical cancer~          that has not responded to standard treatments.~        -  Men at least 18 years of age who have metastatic breast cancer and have a BRCA-1/2~          mutation.~      Design:~        -  Participants will be screened with a physical examination and medical history, as well~          as blood and tumor samples and imaging studies as required by the researchers. Study~          participants will then be divided into two groups.~        -  Group 1: Participants will receive olaparib tablets twice a day for 7 days (14 doses)~          and will receive carboplatin by vein on day 1 or 2, for a 21-day treatment cycle. Group~          1 study is designed to determine the safety of new tablet formulation of olaparib.~        -  Group 2: Participants will be divided into two smaller groups, with reversed treatment~          schedules. Group 2 study is designed to evaluate which drug should be given first~          through endpoint studies in blood samples.~        -  Group 2A: Participants will receive olaparib tablets twice a day for 7 days (14 doses)~          and then carboplatin on day 8 of the first cycle. Cycle 2 will start with carboplatin on~          day 1 and olaparib starting on day 2 for 7 days (14 doses).~        -  Group 2B: Participants will receive carboplatin on the first day of the first cycle, and~          then olaparib on day 2, twice a day for 7 days (14 doses) of the first cycle. Cycle 2~          will start with 7 days of olaparib (14 doses) and carboplatin will be given on day 8.~        -  From cycle 3 until completion of therapy, all Group 2 participants will follow the~          schedule used for Group 1 (carboplatin on day 1 or 2 of the week of olaparib therapy,~          also in 21-day cycles).~        -  Additional blood and tissue samples and imaging studies will be conducted throughout the~          treatment period.~        -  All participants may receive no more than 8 cycles of olaparib and carboplatin therapy,~          but may continue to take olaparib if their cancer responds to the treatment.~   "
177864|NCT01236937|"~     The primary outcome of this study is to investigate the accuracy of respiration gated laser~     guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based~     breath hold monitoring system. Secondary outcome is the rate of complications using laser~     guided CT biopsy in general and with bellows-based breath hold monitoring system. The study~     has approval from the The Danish National Committee on Biomedical Research Ethics (ref no:~     H-4-2010-fsp 1).~   "
177855|NCT01237054|"~     Background:~      - Recent studies have shown that the premalignant conditions monoclonal gammopathy of~     undetermined significance (MGUS) and smoldering multiple myeloma (SMM) have a high risk of~     progressing to multiple myeloma (MM). There are currently no known effective treatments to~     prevent MGUS or SMM from developing into MM, and there are no known tests for determining~     whether an individual with MGUS or SMM will develop MM. Researchers are investigating new and~     improved imaging techniques that may be able to better detect the progression of MGUS or SMM~     into MM.~      Objectives:~        -  To compare the results of three imaging techniques in individuals with MGUS, SMM, and~          MM.~        -  To correlate the information from the imaging studies with established clinical markers~          of progression from MGUS/SMM to MM.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with monoclonal gammopathy of~     undetermined significance, smoldering multiple myeloma, or multiple myeloma.~      Design:~        -  Participants will be screened with a physical examination and medical history, and will~          provide baseline blood, urine, and bone marrow samples before beginning the imaging~          studies.~        -  Participants will have three imaging studies on separate days: a standard~          18-fludeoxyglucose positron emission tomography/computed tomography scan (18-FDG~          PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT),~          and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).~        -  Participants will be closely monitored during each scan, and will provide additional~          blood samples before and after the scans.~        -  Participants may provide additional blood, urine, tissue, and bone marrow samples for~          optional research studies.~   "
177856|NCT01237041|"~     Background:~      - Overweight and obese children and adults often have lower levels of growth hormone in the~     blood. Regulation of growth hormone may be tied to weight and free fatty acids in the blood.~     Current tests of growth hormone (such as those used when evaluating the heights of children~     who are markedly shorter than other children of comparable age) may be affected by other~     factors, including obesity. Researchers are interested in evaluating the levels of growth~     hormone and free fatty acids in the blood of children between 7 and 14 years of age who weigh~     more than children of a comparable age, or who are shorter than other children of a~     comparable age and have been recommended for growth hormone testing as part of an evaluation~     for their height.~      Objectives:~      - To determine the effect of changes in free fatty acids in the blood on changes in growth~     hormone secretion in overweight or shorter children and young adolescents.~      Eligibility:~      - Children and adolescents between 7 and 14 years of age who weigh more than or are shorter~     than other children of a comparable age and do not have any medical illnesses.~      Design:~        -  Participants will have two study visits, one of which will be a half day screening visit~          in the outpatient clinic and one of which will require 2 nights as an inpatient at the~          National Institutes of Health Clinical Center.~        -  Participants should not eat or drink anything except water after 10 PM the night before~          or on the morning of the screening visit.~        -  At the screening visit, participants will have a physical examination and medical~          history, provide blood and urine samples, have an oral glucose tolerance test (to check~          blood sugar levels), and have an x-ray of the left hand to check bone age.~        -  The inpatient study visit will involve a physical examination and medical history, a~          full x-ray scan to study body fat and muscle, frequent blood tests throughout the visit,~          and various medications to stimulate growth hormone production and lower levels of free~          fatty acids in the blood.~   "
177857|NCT01237028|"~     This study will help to show the efficacy of vitamin D and address the optimal strategy to~     minimize renal injury in IgAN patients.~   "
177858|NCT01237015|"~     Current knowledge suggests that, to be successful, oral feeding in preterm babies should be~     initiated as soon as possible, often at an age where immature respiration still requires~     ventilatory support in the form of continuous positive airway pressure (CPAP). While some~     neonatologist teams claim great success with initiation of oral feeding in immature babies~     with CPAP, others strictly wait for CPAP to be no longer necessary before any attempt at oral~     feeding. Such controversy is fuelled by ignorance of the effects of CPAP on nutritive sucking~     and swallowing, including their coordination with breathing, and the fear to induce~     deleterious problems such as pulmonary aspiration of milk and/or respiratory failure. Ensuing~     delay in becoming proficient with oral feeding unduly prolongs hospital stays of preterm~     babies.~      The aim of this study is to evaluate the effects of nasal CPAP on oral feeding in human~     neonates. More specifically, CPAP effects on nutritive sucking and swallowing, including on~     breathing-swallowing coordination, will be carefully assessed. The investigators hypothesize~     that nasal CPAP will lead to no or minimal alterations of breathing-nutritive swallowing~     coordination and will not induce deleterious cardiorespiratory events.~      Accordingly, each neonate will be evaluated during 2 bottle feedings spaced of 24 h, one with~     nasal CPAP 5 cm H2O and the other without any CPAP. Sucking and swallowing activity,~     respiration, heart rate and oxygenation will be continuously recorded before, during and~     after bottle-feeding.~      By filling a gap in knowledge, results from the study will hopefully help neonatologists~     afraid of doing more harm than good when initiating bottle-feeding in preterm babies under~     CPAP to join the many teams for whom it is no more a problem.~   "
177859|NCT01237002|"~     Intermittent Pringle's maneuver is widely used to limit blood loss during hepatectomy,~     without an established time-limit. However, many authors claims its danger for patients'~     outcome. The investigators check the short term outcome of a consecutive cohort of patients~     who underwent hepatectomy with intermittent clamping exceeding 120 minutes.~   "
177860|NCT01236989|"~     Prognostic impact of AR vs NAR~   "
177861|NCT01236976|"~     The study is a multi-centre, assessor-blind, randomised controlled phase III trial in~     patients with with complete or incomplete spinal cord injury between C6 and T12. A total of~     188 participants will be randomised into two groups, the experimental group and the control~     group. The control group participants will receive an upper body strength and fitness~     program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental~     group participants will receive a comprehensive full body exercise program, conducted for 2-3~     hours, three times per week for 12 weeks.~      The main objective of this study is to determine if the experimental exercise program is more~     effective than the upper body strength and fitness program in promoting neurological~     improvement in participants with spinal cord injury.~      Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week~     treatment period followed by 6 month and 12 month (from baseline) follow up assessments.~      Participants will be assessed by a blinded assessor (the assessor will not know which group~     the participants are in) using standard physiotherapy, neurophysiological, fitness and~     functional tests, psychological and quality of life questionnaires, as well as tests of~     immune function and bone structure.~   "
177865|NCT01236924|"~     Slipped disc is the rupture of the fibrous ring, with subsequent displacement of the nucleus~     pulposus in intervertebral spaces, which may cause compression of nerve structures. It is~     estimated that 2-3% of the population have taken with this process, whose prevalence is 4.8%~     in men and 2.5% in women over 35 years. Thus, the purpose of this study is to verify the~     effectiveness of global postural reeducation in patients diagnosed with chronic symptomatic~     lumbar disc herniation with the application of a randomized controlled trial. Will be~     measured pain, disability and functional flexibility.~   "
177867|NCT01236898|"~     The aim of this study is to investigate pharmacokinetics and safety of N-acetylneuraminic~     acid in patients with Distal myopathy with rimmed vacuoles (DMRV) - hereditary inclusion body~     myopathy (hIBM). Dosages are 800mg single and three times a day and 800mg 3 times a day for 5~     consecutive days. N-acetylneuraminic acid and N-glycolylneuraminic acid in serum and urine~     are measured before and after oral administration of N-acetylneuraminic acid.~   "
177868|NCT01236885|"~     This clinical trial studies computer-guided glucose management systems in treating patients~     with hyperglycemia who have undergone blood and bone marrow transplant. A computer-guided~     glucose management system may help manage glucose levels in patients who have undergone blood~     or bone marrow transplant.~   "
177869|NCT01236872|"~     Inorganic nitrate can be converted to nitrite and thence nitric oxide in humans. Nitric oxide~     is normally produced by the inner lining of blood vessels and helps keep blood vessels open~     and therefore blood pressure lower. In subjects with high blood pressure, the inner lining of~     the blood vessels does not function adequately. The investigators wish to investigate whether~     elevating systemic levels of inorganic nitrate (through provision of dietary nitrate-rich~     vegetables) can elevate levels of nitrate/nitrite in hypertensive subjects, and whether this~     has a beneficial effect on blood pressure.~   "
177870|NCT01236859|"~     Intrathecal morphine provides good postoperative analgesia for up to 18-24 hour after~     administration. Pruritus is the most common side effect of intrathecal morphine, which the~     incidence was reported as 20%-100%2 and 63% in Songklanagarind Hospital. Pathophysiology of~     opioid-induced pruritus remain unclear and more than one mechanism may be involved in the~     development of opioid-induced pruritus, such as, mediated central µ opioid receptors,~     Dopamine (D2) receptors, Serotonin (5-HT3) receptors, prostaglandin system, GABA receptors,~     and glycine receptors, so that why opioid-induced pruritus is difficult to manage. Many~     medications have been used to treat this side effect included antihistamines, 5-HT3~     (serotonin) receptor antagonists, opioid antagonists, opioid agonist-antagonists, propofol,~     and nonsteroidal antiinflammatory drugs.~      Gabapentin is an anticonvulsant, a structural analog of aminobutyric acid, and currently~     approved by the Food and Drug Administration for the treatment of partial seizures and~     postherpetic neuralgia. Many studies have shown gabapentin to be effective in the case of~     brachioradial pruritus, itch of neuropathic in origin, uremic pruritus, multiple~     sclerosis-induced pruritus,cholestatic pruritus, itch produced by burn, and pruritus of~     unknown origin. However, there is only one small study in Taiwan shown the effectiveness of~     gabapentin 1200 mg in prevention of intrathecal morphine-induced pruritus in orthopedic~     surgery, which could reduce incidence of pruritus from 77.5% to 47.5% (38.7% reduction).~     Because gabapentin has several side effects especially in high dose such as drowsiness, dry~     mouth, headache, unsteadiness, reduced co-ordination or slowed reaction, constipation,~     diarrhea, peripheral edema, dizziness, confusion, loss of concentration, weight gain, and~     nausea, vomiting, so in our study we decided to reduce the dose of gabapentin. Therefore, we~     would like to know if gabapentin in a smaller dose (600 mg) used in the wider range of age~     including the elderly can decrease the incidence of intrathecal morphine-induced pruritus in~     orthopedic surgery in Songklanagarind Hospital.~   "
177871|NCT01236846|"~     Study is a 12-week Double blind,controlled experiments designed to examine the possible~     effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and oxidative~     stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink intake.~   "
177872|NCT01236833|"~     The objective of this study is determining if enteral administration of Lactated Ringer's~     solution (LR) in preterm infants with feeding intolerance enables for faster advancement of~     milk feeding than fasting.~   "
177873|NCT01236820|"~     The purpose of this study is to determine whether L5, one of the Low Density Lipoproteins, is~     an effective predicting factor for cardiovascular disease in chronic renal and hemodialytic~     patients.~   "
177874|NCT01236807|"~     The purpose of this study is to determine if MR Perfusion Imaging is non-inferior to coronary~     angiography with measurement of Fractional Flow Reserve (FFR) in guiding management of~     patients with stable chest pain.~        -  All patients will undergo an MR Perfusion Imaging test.~        -  Further management will be guided by the result of the cardiac MRI in half of the~          patients (chosen by random).~        -  The other half will undergo coronary angiography with measurement of FFR. The result of~          this test alone will guide their further management. The result of the initial MR~          Perfusion test will not be available to the treating doctors of this group.~        -  All patients will receive optimal medical therapy (OMT)~        -  All patients will undergo follow-up to find out if they have any relevant heart related~          events.~   "
177875|NCT01236794|"~     The purpose of this study is to examine the effects of a lifestyle intervention program on~     type 2 diabetes risk factors and quality of life in overweight Latino youth.~   "
177876|NCT01236781|"~     This multicenter trial using Hologic digital mammography units will evaluate the specificity~     of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D~     tomosynthesis imaging in breast cancer screening. Specificity, in this study, will be~     measured by the participant call-back rate by each modality. Varying combinations of 2-D~     mammography and tomosynthesis projections will be evaluated to optimize the screening~     paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective~     and retrospective imaging data will be assessed.~      Hypothesis: Digital breast tomography (DBT) will improve the specificity of breast cancer~     screening as measured by a reduction in the call-back rate while maintaining the sensitivity~     of cancer detection. This improved accuracy will be achieved by the optimization of the~     imaging sequence and number of views obtained at a capped radiation dose in the combined DBT~     and 2-D screening sequence.~   "
177877|NCT01236768|"~     The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal~     contraceptive delivery system containing ethinyl estradiol and levonorgestrel.~   "
177878|NCT01236755|"~     This study aims at investigating the efficacy of myopic control using ortho-k in younger and~     older children.~   "
177879|NCT01236742|"~     The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects~     who stop the treatment with subjects who continue ortho-k lens wear and control subjects~     wearing single-vision glasses.~   "
177880|NCT01236729|"~     Knee replacement is an effective treatment in late-stage osteoarthritis. It reduces pain and~     improves quality of life. There is, however, limited data concerning its results in older~     people and on its effect on how patients survive in regular activities of daily living (ADL),~     such as bathing and shopping. In this study, the results of knee replacement are evaluated~     from the point of view of disability in everyday activities and self-rated health. Moreover,~     association with ADL performance and clinical knee scores and severity of osteoarthritis are~     assessed.~   "
177881|NCT01236716|"~     This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in~     advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and~     some biomarkers is also to be evaluated.~   "
177882|NCT01236703|"~     CRP and PCT are not valid parameters of early infection in particularly postoperative~     patients. (Sanders et al., A&A, June 2006, Vol.102; Katja et al., Shock, February 2001, Vol~     15.2) Better detection systems for SIRS and sepsis are urgently required.~      ICIS® (Sysmex intensive care infection score) and ICPS® (Sysmex intensive care prognostic~     score) are two new score-systems depending on detectable cellular response of the innate~     immune system in human peripheral blood.~      The purpose of this observational study is to determine if these scores are superior in early~     differentiation between non-infectious SIRS and infectious SIRS (sepsis) in postoperative~     patients. Furthermore, the applicability of the scores for triggering start and ending of~     anti-infective therapy will be examined.~   "
177883|NCT01236690|"~     Cinobufacini has the effects of anticancer, improving the liver function, elevation of~     immunity and little side effects, and is important and significant for the patients with~     hepatitis, liver cirrhosis and hepatomas.~      Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini is~     non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .~   "
177884|NCT01236677|"~     In the 21st century, threats to human health of new respiratory infectious diseases~     increased.~      The project aim is to establish pneumonia pathogens network in Beijing and understand the~     pathogen spectrum distribution.~   "
177885|NCT01236664|"~     With the aging of the Canadian population, older workers are accounting for more and more of~     the working-age population. Despite recent interest in cognitive training, there are~     currently no validated programs that specifically target individuals in the work force. The~     investigators will conduct a small-scale randomized controlled trial to test the~     effectiveness of the previously developed Memory at Work program. The investigators will~     recruit 60 individuals and randomly assign them to the active intervention or a control~     intervention. The investigators will examine outcomes related to knowledge, behavioral~     change, self-efficacy, objective memory, and workplace productivity. The investigators expect~     larger improvements on these measures in the active relative to the control group.~   "
177886|NCT01236651|"~     Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the~     First Stage of Labor in Full Term Primigravidae~   "
177887|NCT01236638|"~     This extension protocol to the core study CCL09101 allows patients who have tolerated the~     drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of~     the core protocol. Long term safety and efficacy of CYT387 will be evaluated.~   "
177888|NCT01236625|"~     Official title:~      LAPAD - A prospective study on the effect of adhesiolysis during elective laparotomy or~     laparoscopy on per- and postoperative complication, quality of life and socioeconomic costs~      Background:~      With improved surgical technology and ageing of the population the number of reoperations in~     the abdomen dramatically increases. The risk for a repeat laparotomy or laparoscopy is a high~     as 30% in the first ten years after a laparotomy. In over 95% of reoperations adhesiolysis is~     required to gain access to the abdominal cavity and operation area. Adhesiolysis~     significantly increases the risk for inadvertent organ damage, such as enterotomies, leading~     to higher morbidity, mortality and socioeconomic costs.~      Purpose:~      To define the impact of adhesiolysis on per- and postoperative complications, quality of life~     and socioeconomic costs.~      Design:~      Prospective observational study.~      Primary outcomes:~        -  adhesiolysis time~        -  inadvertent enterotomy~        -  seromuscular injury~        -  miscellaneous organ damage~        -  Serious adverse events of operation (anastomotic leakage, delayed diagnosed perforation,~          wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection,~          abscess, fistula, sepsis, death)~      Secondary outcomes:~        -  Hospital stay~        -  Intensive care admission~        -  Reinterventions~        -  In-hospital costs~        -  Parenteral feeding~        -  Short term readmissions (30 days)~        -  Quality of life (Gastro- intestinal tract complaints, Short Form- 36(SF-36), DASI (Duke~          Activity Score Index(DASI) )~      Estimated enrollment: 800 start study: 1 june 2008 Inclusion completion date: 1 june 2010~     Estimated study completion date: 1 february 2011~   "
177889|NCT01236612|"~     Malaria is one of the major infectious diseases in the world with a tremendous impact on the~     quality of life significantly contributing to the ongoing poverty in endemic countries. It~     causes almost one million deaths per year, the majority of which are children under the age~     of five. The malaria parasite enters the human body through the skin, by the bite of an~     infected mosquito. Subsequently, it invades the liver and develops and multiplies inside the~     hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the~     blood stream, causing the clinical phase of the disease.~      As a unique opportunity to study malaria immunology and efficacy of immunisation strategies,~     a protocol has been developed in the past to conduct experimental human malaria infections~     (EHMIs). EHMIs generally involve small groups of malaria-naïve volunteers infected via the~     bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although potentially~     serious or even lethal, Plasmodium falciparum (P.falciparum) malaria can be radically cured~     at the earliest stages of blood infection where risks of complications are virtually absent.~      The investigators have shown previously, that healthy human volunteers can be protected from~     a malaria mosquito challenge by immunization with mosquito-bites under chloroquine~     prophylaxis (CPS immunization). However, it is unknown whether this protection is based on~     immunity directed towards the liver- or the blood stage of the disease. For future~     development of vaccines and understanding of protective immunity to malaria, it is important~     to investigate at which level protective immunity is generated by CPS immunization.~     Therefore, we aim to investigate whether CPS immunization confers protection to a blood-stage~     challenge.~   "
177890|NCT01236599|"~     The purpose of this study is to compare the response of temperature adaptation in preterm~     infant using the polyethylene wrap with and without previous drying.~   "
177903|NCT01236430|"~     The intent of this study is to demonstrate that single doses of the Final Market Image (FMI)~     ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are~     bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are~     coadministered as individual tablets in healthy adults.~   "
177904|NCT01236417|"~     This is a pilot study of a specifically designed exercise intervention developed for breast~     cancer patients with aromatase-inhibitor related joint pain.~   "
177891|NCT01236586|"~     Background:~      - The anti-cancer drug RO4929097 is being tested for its ability to block blood vessel growth~     to tumors and slow or stop the growth of cancer cells. However, it has been used in only a~     small number of adults and has not yet been tested in children. Researchers are interested in~     determining whether RO4929097 is a safe and effective treatment for tumors or leukemia that~     has not responded to standard treatment.~      Objectives:~      - To determine the safety and effectiveness of RO4929097 as a treatment for children and~     adolescents who have been diagnosed with certain kinds of cancer that have not responded to~     standard treatment.~      Eligibility:~      - Children, adolescents, and young adults between 1 and 21 years of age who have been~     diagnosed with solid, nervous system, or blood-based cancers that have not responded to~     standard treatment.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and imaging studies. Some participants may also have a bone marrow biopsy~          to evaluate the state of their disease.~        -  Participants will be separated into three groups: One group will receive RO4929097~          alone, and the other two will receive RO4929097 in combination with the~          immune-suppressing drug dexamethasone.~        -  RO4929097 will be given as tablets on one of two schedules: days 1 to 3 of every week~          (Schedule A) or days 1 to 5 of every week (Schedule B). The dosing schedule will be~          determined randomly. Every 4-week treatment period is one cycle, and participants may~          receive RO4929097 for up to 24 cycles.~        -  Participants will have frequent blood and urine tests and imaging studies to evaluate~          the progress of treatment, and will be asked to keep a diary to monitor any side~          effects.~   "
177892|NCT01236573|"~     Background:~      - One experimental treatment for certain types of cancer is cell therapy, which involves~     collecting lymphocytes (white blood cells) from a tumor, growing them in the laboratory in~     large numbers, and then modifying the cells with a gene (interleukin-12 (IL-12)) that~     stimulates the immune system to attack and destroy the cancer cells. Because this treatment~     is experimental, researchers are interested in determining the side effects and overall~     effectiveness of cell therapy using white blood cells modified with IL-12 as a treatment for~     aggressive cancer.~      Objectives:~      - To determine the safety and effectiveness of cell therapy using IL-12 modified tumor white~     blood cells to treat metastatic melanoma.~      Eligibility:~      - Individuals greater than or equal to 18 years of age and less than or equal to age 66 who~     have been diagnosed with metastatic melanoma.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and imaging studies.~        -  Cells for treatment will be collected during tumor biopsy or surgery.~        -  Prior to the start of cell therapy, participants will have imaging procedures, heart and~          lung function tests, and blood and urine tests, as well as leukapheresis to collect~          additional white blood cells.~        -  For 5 days before the cell infusion, participants will be admitted for inpatient~          chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in~          preparation for the cell therapy.~        -  Participants will receive the modified white blood cells as an infusion 1 to 4 days~          after the last dose of chemotherapy. The day after the infusion, participants will~          receive filgrastim to stimulate blood cell growth.~        -  Participants will remain as inpatients for at least 5 to 10 days to recover from the~          treatment, and will be followed regularly after the treatment to study side effects and~          general effectiveness.~        -  Participants who initially respond to treatment but have a relapse may have one~          additional treatment using the same procedure.~   "
177893|NCT01236560|"~     This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to~     see how well they work compared with each other when given together with radiation therapy~     followed by bevacizumab and temozolomide in treating young patients with newly diagnosed~     high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses~     high-energy x-rays to kill tumor cells. It is not yet known whether giving vorinostat is more~     effective then temozolomide or bevacizumab when given together with radiation therapy in~     treating glioma.~   "
177894|NCT01236547|"~     This randomized phase II trial studies the side effects and how well intensity-modulated~     radiation therapy (IMRT) and paclitaxel with or without pazopanib hydrochloride works in~     treating patients with anaplastic thyroid cancer. Specialized radiation therapy that delivers~     a high dose of radiation directly to the tumor may kill more tumor cells and cause less~     damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether radiation therapy and paclitaxel are more effective when given with pazopanib~     hydrochloride in treating thyroid cancer.~   "
177895|NCT01236534|"~     The purpose of the study is to assess how safe and effective the drug Lubiprostone is in~     people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation.~     Lubiprostone is approved by the FDA for the treatment of two common types of constipation in~     adults, chronic idiopathic constipation and irritable bowel syndrome.~   "
177896|NCT01236521|"~     The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized~     clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for~     chronic lower back pain. The study aims are: 1) to compare the interventions' (PHARM vs. BEH)~     effects on pain intensity, function, and other pain relevant outcomes at 6 months (primary~     end point) and 12 months (sustained effect); and 2) to compare the cost-effectiveness of the~     interventions~   "
177897|NCT01236508|"~     The investigators hypothesize that inflammation in carotid plaque is predictive of the extent~     of ischemic lesion burden on the brain and will add to risk stratification for individuals~     with carotid disease.~   "
177898|NCT01236495|"~     The purpose of the study is to evaluate the amount of total pethidine requirement during the~     48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.~   "
177899|NCT01236482|"~     In this study the investigators hypothesize that infused combinations of oxytocin and~     ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion~     of oxytocin alone. In order to perform this study the investigators perform the following~     steps:~        1. The investigators validate a quantitative measure of uterine tone as our primary~          endpoint.~        2. The investigators use this endpoint measure in order to determine equipotential doses of~          different tocotonic drug regimens, based on the ED50 for each.~        3. Using equipontial ratios based on the ED50, the investigators compare hemodynamic and~          other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be~          measured.~   "
177900|NCT01236469|"~     The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human~     Heart Valve used in pediatric patients as an aortic valve replacement.~   "
177905|NCT01236404|"~     Primary objective:~      To evaluate the safety and tolerability of single and multiple ascending doses of PB1023~     administered as a subcutaneous (SC) injection in adult subjects with T2DM.~      Secondary objectives:~        1. To characterize the pharmacokinetic profile of PB1023 after single and multiple~          ascending doses of PB1023.~        2. To assess the pharmacodynamic response of various single and multiple doses of PB1023~          (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in~          response to a liquid Mixed Meal Tolerance Test (MMTT).~   "
177906|NCT01236391|"~     The primary objective of this study was to evaluate the efficacy of ibrutinib in participants~     with relapsed or refractory MCL.~      The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg~     daily) of PCI-32765 in this population.~   "
177907|NCT01236378|"~     Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China~     for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK) study to~     be conducted in renal allograft recipients was requested by State Food and Drug~     Administration (SFDA) to provide further guidance for clinical use.~      To minimize risk to patients, this study is designed to collect blood PK samples from renal~     allograft recipients who are currently under sirolimus (1 mg tablets) treatment with or~     without concomitant medication(s). PK samples will be collected from these patients to~     characterize the steady state PK of sirolimus during sirolimus maintenance therapy. This~     study will not involve any changes to the established treatment regimen for the patients who~     enroll in the study~   "
177908|NCT01236365|"~     Children with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due~     to chronic increase in the blood sugars and inflammation. If there is also increased in~     cholesterol, it creates a highly abnormal environment not fully corrected by improved control~     of the blood sugars. CVD remains the principal risk of mortality in T1DM, and its prevention~     and treatment, compelling in children. This grant proposal encompasses 3 separate, yet~     interrelated projects addressing different aspects of CVD risk in children with T1DM. Project~     #1: a randomized controlled trial on the safety and efficacy of a class of drugs called~     statins, which lower bad cholesterol in the body, in children with diabetes and elevated~     bad cholesterol. We will measure changes in concentration of blood inflammatory markers and~     for the 1st time, correlate levels of these markers with changes in blood sugar as measured~     by continuous glucose sensors, instruments that measure the blood sugar continuously through~     a small needle under the skin. Project #2: is a laboratory study to investigate the genetics~     and concentration of key molecules that participate in the inflammatory cascade and~     atheromatous plaque formation that causes CVD. Expression levels in children with T1DM will~     be compared with those in healthy controls for the 1st time. Project #3: examines the use of~     abdominal aortic MRI to measure damage to the arteries in children with T1DM and healthy~     age-matched controls. The results of these studies will likely provide important new data on~     the use of statins in children with diabetes.~   "
177909|NCT01236352|"~     The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable~     in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to~     permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to~     determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.~   "
177910|NCT01236339|"~     The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS~     Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have~     cirrhosis of the liver with portal hypertension and difficult to treat ascites.~   "
177911|NCT01236326|"~     Laparoscopic nephrectomy (removal of the kidney) is the most common procedure for people~     donating a kidney to be used for living donor kidney transplantation. Laparoscopic donor~     nephrectomy (LDN) was a great advance in the field of living donor kidney transplantation due~     to the many advantages it offers over open nephrectomy, including significantly shorter~     hospitalization and recovery time, and significantly improved cosmetic result related to the~     nephrectomy scar(s). More recently, a new procedure has been introduced to the field of~     laparoscopic nephrectomy, called laparoendoscopic single site donor nephrectomy (LESS-DN). In~     the LESS-DN procedure, a single natural orifice (the umbilicus or belly button) is used as~     the single incision site through which the entire donor nephrectomy is performed. The LESS-DN~     procedure may further decrease donor morbidity by further decreasing length of stay,~     lessening recovery time, and improving satisfaction with the surgical scar. The investigators~     propose to evaluate conventional LDN versus a LESS-DN in a randomized, controlled trial in~     living kidney donors. The investigators will compare operative times and intra-operative~     donor management, intra- and post-operative complications, pain scores, analgesic~     requirements, length of stay, recovery parameters, surgical scar satisfaction, and function~     and survival of the transplanted kidney for the two groups of subjects: (1) the group that~     has the conventional laparoscopic donor nephrectomy; and, (2) the group that has the~     laparoendoscopic single site donor nephrectomy.~   "
177912|NCT01236313|"~     The purpose of this study is to prospectively determine the relationship between the~     dimensions of the aorta (the large artery taking off the heart) and blood pressure during~     cardiac surgery.~   "
177913|NCT01236300|"~     Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy~     (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous~     from non-mucinous cysts)~   "
177914|NCT01236287|"~     Voclosporin is an investigational medication previously studied to prevent acute rejection in~     patients who receive a kidney transplant. This study is a compassionate release program where~     subjects previously participating in the study entitled A Phase 2B, Randomized, Multicenter,~     Open-Label, Concentration Controlled, Safety Study of ISA247 and Tacrolimus (Prograf®) in~     denovo Renal Transplant Patients (ISA05-01) may be eligible to continue to receive~     voclosporin despite the Phase 2B study being terminated by the sponsor. Under the~     compassionate release program, subjects previously taking voclosporin may continue to receive~     the study medication until the drug is FDA-approved and commercially available in the United~     States.~   "
177965|NCT01235624|"~     Identify new genes responsible for autosomal dominant retinitis pigmentosa (ADRP), one of the~     most common causes of hereditary diseases of the retina, and thus better understand the~     mechanisms involved of the disease.~   "
177915|NCT01236274|"~     A number of studies have suggested an association between the use of antipsychotic agents and~     cardiovascular mortality. However, the relationship between cardiac events and the use of~     antipsychotic drugs is not clear. Patients experiencing psychoses and in need for~     antipsychotic agents may be at a higher risk of cardiac events regardless of any effect of~     antipsychotic medication. Two studies have specifically investigated the association between~     the use of antipsychotics and the risk of cardiac events using Myocardial Infarction (MI) as~     an outcome measure, reporting no association and a positive association respectively. This~     difference in results may be explained by the use of different measures as well as study~     designs in both studies and because of different limitations with regard to controlling for~     lifestyle and medical risk factors. This study aims to assess the relationship between the~     risk of MI and recent exposure to antipsychotic agents by using the self-controlled case~     series method with which we are able to control for fixed confounders. The results of the~     self-controlled case series method will be compared to the results of a case-control study~     using the same data to compare the estimates of both methods.~   "
177916|NCT01236261|"~     The aim of this study is to describe the epidemiology of fungal blood infections in Spain~     (with emphasis on the incidence, fungal species distribution and antifungal susceptibility).~     The study is to be performed in five big cities which represent different geographic areas:~     Barcelona, Bilbao, Madrid, Sevilla and Valencia.~   "
177917|NCT01236248|"~     The purpose of this study is to determine a computer- and family-based drug abuse prevention~     program is able to reduce drug use among early adolescent girls.~   "
177918|NCT01236235|"~     The purpose of this study is to describe long term (> 96 weeks) efficacy and safety of~     Atazanavir-based regimens in real life setting.~   "
177919|NCT01236222|"~     The purpose of this study is to determine whether cycling to school is effective in the~     prevention of the metabolic syndrome.~   "
177920|NCT01236209|"~     The overall objective of this randomized controlled study (RCT) financed by the Norwegian~     Research Council (grant no. 182012/V50) is to establish the effectiveness of situational~     feedback to the self-management of fibromyalgia syndrome (FMS) using innovative means of~     patient-provider communication in a randomized controlled study (RCT). Thereby this project~     will contribute to the knowledge of treatment of patients with FMS. The effectiveness of the~     intervention will be expressed in terms of a) reduced pain, b) psychometric outcomes, c)~     quality of life, d) improved engagement in daily activities and e) prevented transition to~     chronic disability. We furthermore aim to 1) determine the effectiveness of providing regular~     situational feedback in enhancing self-management and, consequently 2) study the~     effectiveness of enhancing self-management in reducing pain and physical disability.~      Self-management of chronic pain is increasingly seen as an important tool in providing~     adequate care to patients with FMS and other types of Chronic Non-malignant Pain. Enhancing~     the patient's self-management of her/his condition is thought to be effective in reducing~     pain and disability. However, sufficient empirical evidence to support this is yet~     unavailable. This may be due to the non-situational nature of many interventions studied so~     far: Patients are taught management skills in a clinical setting, and may not be able to~     successfully use these skills in daily care. Therefore, enhancing self-management of chronic~     pain, by providing immediate feedback that is directly related to patient's daily life~     (situational feedback) complementary to care-as usual, is thought to be more effective than~     conventional interventions in a clinical setting. This may even be even more effective when~     the patient receives quick response feedback using mobile communication technology, i.e. any~     place any time.~   "
177921|NCT01236196|"~     We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior~     therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and~     randomizing them into one of two treatment conditions. The study sample was recruited from~     primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based~     outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa~     Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved~     muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction.~     Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a~     20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks~     (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample~     size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study~     hypothesis, assessment methodology, and intervention procedures were based on the~     cognitive-behavioral model of chronic pain.~   "
177922|NCT01236183|"~     To determine number of cases need to perform in new anesthesia residents to be proficient in~     manual skills.~   "
177923|NCT01236170|"~     The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with~     SCI and more than 40,000 Veterans with amputated limbs (AL). Despite VA's efforts to remove~     financial and other barriers to the provision of wheelchairs to all Veterans who need them,~     preliminary evidence suggests that disparities exist in the quality of wheelchairs prescribed~     to racial minorities and low income Veterans with SCI or AL. The proposed project will~     provide important information to the VA about the quality and equity of wheelchairs provided~     to Veterans with SCI or AL, and it will identify the patient and provider factors associated~     with wheelchair provision. Because Veterans with SCI and AL are considered special disability~     populations, identifying and understanding these factors is a critical first step to~     developing interventions to increase the quality and equity of wheelchairs provided to all~     disabled Veterans.~   "
177924|NCT01236157|"~     Support pre-hospital chest pain remains a difficult problem in both pre hospital regulation~     that when supported by the Mobile Services Emergency and Intensive Care (SMUR).~      This ground of appeal underlying various pathologies especially acute coronary syndrome whose~     early care diagnostic and treatment significantly improves the prognosis.~      The recognition and management of SCA is therefore a public health issue. Myocardial~     infarction (MI) is responsible for 10 to 12% of the total annual mortality in adults and~     coronary heart disease is the leading cause of death in France.~      No studies have assessed the adequacy of regulation and management of chest pain SAMU for the~     diagnosis of SCA.~      The main objective of the research is to have a descriptive analysis of the population~     controlled by the SAMU and the population served by the mobile emergency with chest pain.~     Also evaluate the adequacy of the proposed direction by the ambulance SAMU/SMUR and the final~     diagnosis and direction after passing emergency, cardiology and at follow-up to a year.~   "
177966|NCT01235598|"~     Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic~     Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials~     (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.~   "
178432|NCT01229462|"~     This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed~     combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in~     patients with glaucoma or ocular hypertension who do not respond well to topical beta~     blockers.~   "
177925|NCT01236144|"~     The AML18 Pilot Trial will evaluate the feasibility of three interventions that are planned~     to be included in the forthcoming NCRI AML18 Trial. One intervention will be to evaluate~     combining the Tyrosine Kinase Inhibitor AC220 with three courses of standard DAE~     (Daunorubicin, Ara-C, Etoposide). AC220 will be given following each treatment course, daily~     by mouth for 7, 14 or 21 days. AC220 will be evaluated at 3 dose levels of 60, 90 and 135 mg~     flat dose. A 4th dose level of 40 mg will be introduced should patients not respond well to~     60 mg. The second intervention to be tested is the combination of the CXCR4 inhibitor~     Plerixafor with up to three courses of the chemotherapy combination of DClo (Daunorubicin,~     Clofarabine). Patients/investigators will be able to choose which intervention to enter.~     Depending on recruitment requirements, only one intervention might be available at any one~     time. The third intervention Patients will receive 3 treatments of 100 mg of ganetespib on~     days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The~     chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which~     will be associated with 3 administrations of ganetespib.~   "
177926|NCT01236131|"~     The goal of this project is to identify the microorganisms present in the endometrial samples~     obtained from women with or without evidence of endometritis using a combination of culture~     methods, rRNA sequencing and whole genomic sequencing. The overarching aim of these studies~     is to identify the etiology of endometritis. The investigators will define the role of~     fastidious anaerobic microorganisms in the etiology of PID, and assess whether antibiotic~     treatment regimens used for the treatment of PID have activity against the novel organisms~     linked with pelvic infections.~   "
177927|NCT01236118|"~     The purpose of this study is to evaluate the safety and tolerability of LY2439821~     subcutaneously administered for 48 weeks in Japanese participants with rheumatoid arthritis~     who have completed Study I1F-JE-RHAL (NCT01253265).~   "
177928|NCT01236105|"~     The purpose of this study is to determine the effect of activated charcoal and dosing time on~     the absorption of LY2624803 in healthy subjects. In this crossover study, there are three~     treatments with a washout period of at least 7 days in between treatments. Each subject will~     participate in all three treatments with random assignment to the treatment sequence.~   "
177929|NCT01236092|"~     The most common chronic low back pain conditions are a consequence of disc disease as well as~     muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the~     space containing the spinal cord or a nerve root resulting in severe pain. A common treatment~     is then surgery. Whole-body vibration combined with un-weighting traction and specific manual~     mobilization plus active therapeutic exercise seems to treat chronic low back pain by~     non-invasively firing muscles of the lumbar spine. The investigators are seeking to show such~     therapy reduces the need for surgery and significantly out performs traditional physical as~     the preferred conservative treatment.~   "
177930|NCT01236079|"~     The goal of this patient-randomized effectiveness trial is to demonstrate that an inpatient~     technology-supported assisted referral (I-TSAR) and follow-up approach is an effective and~     cost-effective method to help hospitalized patients successfully quit smoking. The proposed~     study represents a unique opportunity to assess the effectiveness and cost-effectiveness of~     linking inpatient and outpatient delivery of smoking cessation services in two large and very~     different health care delivery systems. We will enroll 900 participants (600 intervention,~     300 controls) over 15-months and collect follow-up survey and health care utilization data~     over 12 months to estimate: 1) smoking abstinence at 6 and 12 months for I-TSAR intervention~     recipients compared to usual care; 2) the dose effect on smoking abstinence at 6 and 12~     months for I-TSAR recipients compared to usual care; 3) total and mean costs per participant~     for I-TSAR and usual care recipients, and, if effective, estimate the incremental~     cost-effectiveness of the intervention vs. controls at 12 months from health plan/insurer and~     societal perspectives; and 4) differences in health care utilization at 12 months for I-TSAR~     versus controls.~   "
177931|NCT01236066|"~     This study aims to monitor the incidence rates and duration of hospitalisations for rotavirus~     gastroenteritis (RV GE) and all cause GE, compared to bronchiolitis from 1998 to 2009, in~     children < 5 years of age after the introduction of Rotarix in 2006 by year, both inside and~     outside rotavirus season in Australia. It further aims to compare the two dose regimen of~     Rotarix with the three dose regimen of RotaTeq from 2007 to 2009.~   "
177932|NCT01236053|"~     High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there~     has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by~     spontaneous reports in AERS or in the published literature. In a published case-control~     screening study of the association of gabapentin with 55 cancers, the only cancer that met~     the screening criteria for possibly increased cancer risk with gabapentin exposure was renal~     (including renal pelvis) cancer. This association was judged to be likely due to or~     substantially accentuated by confounding by cigarette smoking, hypertension, and lifestyle~     (Cancer Causes Control 2009;20:1821-1835).~      The relationship between gabapentin exposure and pancreatic cancer and renal cancer is~     studied in NCT01138124, and supplemental analyses for these cancers are performed in the~     current study. The FDA recommended GSK also study the relationship between gabapentin and~     all-cancer sites, as well as cancer at the following specific sites: 1) stomach, 2) anus,~     anal canal, and anorectum, 3) lung and bronchus, 4) bones and joints, 5) breast, 6) penis, 7)~     urinary bladder, and 8) other nervous system.~      The primary objective of this study is to determine whether exposure to gabapentin is~     associated with an increased risk of developing all-cancer, and these specific cancers in the~     United Kingdom (UK) General Practice Research Database (GPRD). Each member of the UK~     population is registered with a General Practice, which centralizes the medical information~     not only from the general practitioners themselves but also from specialist referrals and~     hospital attendances. Over 487 General Practices contribute data to the GPRD.~      The study cohort from which cases and controls are drawn is all subjects in the GPRD~     1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins~     Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of~     registration if later than Jan 1, 1993. Subjects are excluded from the GPRD cohort if they~     have a cancer diagnosis or a history of cancer prior to the cohort entry date. Patients with~     a first diagnosis of the respective cancer 1995-2008 are risk set matched with up to 10~     controls within the same General Practice for age at cohort entry (within two years), sex,~     and year of entry into the study cohort (within one year). For cases, the index date is the~     date of first diagnosis of the respective cancer. The index date for controls is set as the~     date at which the follow-up time from cohort entry is the same as the case. The index date is~     chosen so as to give the control equal follow-up time to that of the case for ascertainment~     of use of gabapentin. Cases and controls will be required to have at least 2 years of~     follow-up in the study cohort before their index date. Cases must have no history of any~     other cancer diagnosis prior to the index date. Controls are required to be free of cancer~     diagnosis in the database up to the control's index date.~      Data on gabapentin prescriptions are obtained for cases and controls from study cohort entry~     to the index date. Gabapentin exposure will be assessed as ever/never, number of~     prescriptions, cumulative dose, and cumulative duration, with a 2 year lag period~     incorporated to control for protopathic bias (gabapentin prescription for initial pain~     symptoms of undiagnosed cancer) and latency (time between cancer onset and specific GPRD~     cancer diagnosis).~      Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from~     conditional logistic regression models, with additional analyses evaluating for~     dose-response. Covariates include indications for gabapentin use and risk factors for each~     cancer.~   "
177933|NCT01236040|"~     This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate~     vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.~   "
177934|NCT01236027|"~     Biologic samples are necessary for development and validation of laboratory procedures (e.g.~     novel biological and analytical assays, explant tissue models, validation of specimen~     collection and transport) to support future infectious disease clinical studies. In this~     research study, the investigators will collect blood samples, vaginal swabs, cervical swabs,~     mucus/vaginal discharge, cervicovaginal lavages, vaginal and cervical biopsies, as necessary,~     to use in the development of laboratory processes. The investigators will obtain the~     sample(s) from healthy HIV negative women. Samples will be collected and sent to Magee-Womens~     Research Institute as laboratory specimens are needed.~   "
177935|NCT01236014|"~     An indirect comparison to compare the efficacy of eltrombopag versus romiplostim~   "
177936|NCT01236001|"~     Observational study at the request of the Belgian Institut National d'Assurance~     Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV:~        -  type of patient treated with VIMPAT®~        -  VIMPAT® dose~        -  Effect of VIMPAT® on evolution of seizure control~        -  Persistence rate at 6 months in terms of treatment duration~        -  Discontinuation rate~        -  Description of any changes in other epilepsy therapies~        -  Safety and tolerability~   "
177937|NCT01235988|"~     The purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo~     (standard of care)~   "
177938|NCT01235975|"~     This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK~     134612 given as single dose to healthy adults 56 years or older compared to the meningococcal~     polysaccharide vaccine MencevaxACWYTM.~   "
177939|NCT01235962|"~     This randomized Phase III study is to evaluate whether pazopanib compared with placebo can~     prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of~     developing recurrence after undergoing kidney cancer surgery~   "
177940|NCT01235949|"~     The aim of the current study is to determine whether ibuprofen, given as immediate or delayed~     prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune~     response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals'~     10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3,~     4 and 5 months of age.~      In addition, this study will further evaluate the impact of prophylactic administration of~     paracetamol following primary vaccination with immediate or delayed administration or when~     given in an immediate manner at the time of the booster dose.~   "
177941|NCT01235936|"~     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of repeat~     doses of orally administered AKB-6548 in pre-dialysis subjects with anemia.~   "
177942|NCT01235923|"~     Preterm infants are a risk for multiple transfusions, and the administration of human~     recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing~     usually occurs three times a week, but extended dosing schedules have been successful in~     adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard~     three times weekly dosing.~   "
177943|NCT01235910|"~     The purpose of this study is to evaluate the safety and efficacy of the blood pressure~     medication, aliskiren, in heart transplant patients. In terms of safety, the investigators~     will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood~     levels of the anti-rejection medication, cyclosporine, in these patients. In terms of~     efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart~     transplant patients.~   "
177944|NCT01235897|"~     The purpose of this study is to test the safety and safest highest dose of an investigational~     drug called MK-2206 when given in combination with paclitaxel and trastuzumab in patients~     with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing solid tumor malignancies.~   "
177945|NCT01235884|"~     Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of~     life can reduce the onset of gaseous colic in neonates and the onset of minor digestive~     disorders such as regurgitation and constipation.~      Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42~     gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or~     placebo for 28 days.~      After the inclusion, at baseline will be performed :~        -  Paediatric visit~        -  antropometric valutation~        -  number of the daily crying minutes, number of regurgitation and number of daily~          evacuation~      The patients will receive the probiotics/placebo every days for 28 days and the 29th will be~     repeated the following analyses:~        -  Paediatric visit~        -  antropometric valutation~        -  number of daily crying minutes~        -  numbers of regurgitation~        -  numbers of evacuations~      Primary outcome :~      To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic,~     regurgitation and of constipation.~      Inclusion criteria~        -  neonates of 37-42 week gestational age and appropriate birth weight~        -  Recruitment age: until 7 days of life~        -  Informed consent signed~      Exclusion criteria~        -  Presence of other gastrointestinal diseases.~        -  Use of FANS, aspirin or other drugs~        -  Use of antibiotics and/or PPIs e/o anti-H2~        -  Participation to other clinical trials~   "
177946|NCT01235871|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of SB1578 in healthy volunteers.~   "
177947|NCT01235858|"~     There is an increasing trend in the incidence of infection related to epidural anesthesia.~     This could be related to methods of aseptic technique as adopted by the anesthesiologist~     during the performance of the procedure.~      The purpose of this study is to compare two methods of aseptic technique for labor epidural~     insertion; a conventional method without wearing a sterile gown (free from living germs or~     microorganisms) versus strict aseptic method with wearing of sterile gowns.~      It is our belief that there will be an increased contamination of epidural equipment and~     colonization of epidural catheter, secondary to bacterial fallout from the operators' bare~     hands in the group not wearing the sterile gowns.~   "
177948|NCT01235845|"~     Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis~     carries with it a median survival of approximately 12 months, with 90 - 95% of patients~     surviving less than 2 years. The current standard treatment of surgical resection followed by~     radiation therapy and chemotherapy has not substantially prolonged survival.~      Dendritic cells (DCs) are immune cells that form part of the mammalian immune system. Their~     main function is to process antigen material and present it on the surface to other cells of~     the immune system, thus functioning as antigen-presenting cells.In the present study, DCs~     were used for antigen presentation of glioma antigens to directly induce a cytotoxic T-cell~     response. Cytokine-induced killer (CIK)cells are shown to be a heterogeneous population, and~     the major population expresses both the T cell marker CD3 and the NK cell marker CD56, and is~     termed NKT cells, which has shown significant anti-tumor activity in both clinical trials and~     animal studies.~      Furthermore, CIK cells are able to expand significantly when they are cultured with DCs, and~     the CIK cells activated by DCs stimulation (DCIKs)have a characteristic which cytotoxic~     activity enhanced and show increased anti-tumor activity.~      This study aimed to evaluate the clinical efficacy of DCIK cells treatment combined with DCs~     following tumor resection and radiotherapy in patients with malignant glioma.~   "
177949|NCT01235832|"~     The investigators propose to evaluate the effects of avocado consumption (by incorporating 1~     unit of fruit per day into a healthy diet) on multiple cardiovascular disease (CVD) risk~     factors. The investigators will compare chronic consumption of a moderate fat blood~     cholesterol-lowering diet incorporating one avocado per day versus a blood~     cholesterol-lowering Lower-Fat diet on established CVD risk factors including lipids and~     lipoproteins, and blood pressure (BP). The investigators also will evaluate the effects of an~     avocado diet on several emerging CVD risk factors. To elucidate the specific benefits of~     avocado and its accompanying bioactives on the aforementioned risk factors, the investigators~     will compare the avocado diet with a diet that has the same macronutrient profile (but~     without the avocado).~   "
177950|NCT01235819|"~     To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1~     diabetes patients.~   "
178020|NCT01234896|"~     Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study~     in healthy smokers.~   "
177951|NCT01235806|"~     The Alpes Maritimes county administration (France) equipped Nice University Hospital of a~     0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the~     medical imaging unit.~      The aim of our project is to study its interest in diagnosis of scaphoid fractures.~      Conventional medical care for patients being suspected to have a scaphoid fracture consists~     in performing a clinical examination and a radiographic check-up with at least 4 incidences,~     which 2 specific incidences for the scaphoid bone.~      Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation~     and false negatives delays in patient medical care, increasing the risk of complication.~     Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to~     professional reclassification.~      Alternative imaging exists, but is often irradiating, and never reaches the optimal~     specificity and sensitivity.~      MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of~     cases. The problem is the lack of accessibility for emergency cases; therefore there is a~     great interest in validating the use of a MRI dedicated to distal articulations.~      The few studies that study costs of diagnosis strategies including MRI in scaphoid bone~     fractures diagnosis show a reduction of medical costs if this technique is used early. Our~     project represents an essential initial step in evaluating the impact of a low field MRI~     dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will~     be a medico-economical study, since scaphoid fractures occur frequently.~      Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.~   "
177952|NCT01235793|"~     The primary purpose of the study will be testing the dosing of temozolomide to find the~     target dose that a person can tolerate. The other part of the study will be determining how~     helpful it can be to CNS lymphoma patients by adding temozolomide to the conditioning~     regimen prior to stem cell transplantation.~      This research study is designed to test the investigational use of temozolomide as part of a~     conditioning regimen prior to stem cell transplantation. This drug has not yet been approved~     by the U.S. Food and Drug Administration (FDA) to be used in the setting of stem cell~     transplantation in lymphomas of the brain (central nervous system or CNS) but it has been~     studied and used before in transplantation with reasonable results.~   "
177953|NCT01235780|"~     The purpose of the study is to investigate the factors affecting corneal hysteresis (CH) in~     Taiwanese.~   "
177954|NCT01235767|"~     The purpose of this study is to determine if a nutrient-rich supplement of animal-source~     foods ingested 5d/wk from pre-conception to term improves maternal nutrient status, decreases~     infections, and improves birth weight and rates of prematurity compared with supplemental~     ingestion during pregnancy ( from mid-gestation to term) or routine prenatal care.~   "
177955|NCT01235754|"~     The objective of this study is to evaluate the persistence of benefit of LibiGel~     (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of~     Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.~   "
177956|NCT01235741|"~     Following screening, eligible subjects will be enrolled into a 6‑week Low Calorie Diet (LCD)~     lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week~     LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or~     placebo) to begin a 16-week treatment period during which the effect on body weight of~     treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week~     blinded core treatment period, subjects will discontinue study medication for a period of 12~     weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate~     a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week~     off-drug and 12 week open label treatment periods, subjects will continue to participate in a~     Lifestyle Intervention (LSI) program.~   "
177957|NCT01235728|"~     This is a within-participant comparison study to investigate the efficacy of a 28-day regimen~     of MK-0873 2% cream twice a day (b.i.d.) compared to MK-0873 vehicle (matching placebo)~     b.i.d. as well as to a positive control comparator calcitriol 0.0003% (3 µg/g) in~     participants with plaque psoriasis. In order to be enrolled in the study, patients need to~     have at least two pairs (lesions AB and CD) of approximately similar plaque lesions in~     severity and size of surface area involved and located in approximately symmetric regions~     such as the trunk or limbs of the body. Participants will be randomly assigned to apply~     either MK-0873 or MK-0873 vehicle to plaque A or B and will be randomly assigned to apply~     MK-0873 or calcitriol to plaque C or D. It is hypothesized that MK-0873 cream formulation~     administered to participants with psoriasis by the topical route will result in a~     statistically greater percent target lesion severity (TLS) reduction in plaque lesion than~     will MK-0873 Vehicle on Day 29.~   "
177958|NCT01235715|"~     Application of Evicel hemostatic matrix during operation for unilateral total knee~     replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a~     reduction in transfusion requirements, and less reduction of hemoglobin.~   "
177959|NCT01235702|"~     A 12-week treatment/control trial was implemented to assess the effects of a multi component~     lifestyle program on improvements in body mass index, weight, perceived stress and blood~     pressure in African American men and women who were at increased risk for cardiovascular~     disease. It was hypothesized that treatment group would experience significant improvements~     when compared to the control group.~   "
177960|NCT01235689|"~     The primary objective of this study was to demonstrate that tight control of disease~     activity, using stringent criteria based on Crohn's disease activity Index (CDAI), biomarkers~     (high sensitivity C-reactive protein [hs-CRP] and fecal calprotectin), and corticosteroid~     use, improves the rate of mucosal healing 48 weeks after randomization compared with~     management using less stringent criteria based only on CDAI and corticosteroid use.~   "
177961|NCT01235676|"~     0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle~     intervention during pregnancy~   "
177962|NCT01235663|"~     0-hypothesis: advisory support does not~        1. prolong the the breast-feeding period~        2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers~   "
177963|NCT01235650|"~     This is a retrospective chart review of patients undergoing spinal fusion surgery to see the~     prevalence of hyperventilation.~   "
177964|NCT01235637|"~     The main objective is to assess the efficacy of Alfentanil for pain in children treated by~     tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the~     current standard treatment.~   "
177967|NCT01235585|"~     This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally~     controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will~     be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks,~     followed by an optional treatment extension for up to 3 years.~   "
177968|NCT01235572|"~     This phase II trial studies how well early discharge and outpatient care works in patients~     with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive~     chemotherapy. Gathering information about patients with myelodysplastic syndrome or acute~     myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital~     until blood counts return to normal, may help doctors learn more about the safety of allowing~     patients to leave the hospital early, the patient's quality of life, use of medical services,~     and the cost of these services associated with such a policy.~   "
177969|NCT01235559|"~     This randomized, multi-center double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally~     controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will~     be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks,~     followed by an optional treatment extension for up to 3 years.~   "
177970|NCT01235546|"~     The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic~     multi-center randomized clinical trial designed to evaluate the comparative effectiveness and~     safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus~     standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin~     (preferably prior to surgical incision) to prevent post-cesarean infection.~      Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if~     cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum~     prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.~   "
177971|NCT01235533|"~     To investigate whether fish oil supplementation, compared to placebo (olive oil), could have~     better effects on depression course and cognitive function in older people with major~     depression.~   "
177972|NCT01235520|"~     This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled~     symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be~     randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks,~     followed by an optional treatment extension for up to 3 years.~   "
177973|NCT01235507|"~     This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra~     (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe~     rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic~     drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800~     mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued~     at a stable dose. Anticipated time on study treatment is 24 weeks.~   "
177974|NCT01235494|"~     To develop techniques with MRI of Helium-3 gas to give functional images of the lungs. The~     goal is to test a single breath-hold functional 3-He MRI pulse sequence with sensitivity to~     multiple functional aspects of the luncg physiology. A group of 20 healthy volunteers willbe~     recruited from the local research group and the results compared with existing methods that~     require seperate breath-holds of 3He gas~   "
177975|NCT01235481|"~     The Public Health Agency of Canada estimates that over 3.5 million Canadians live with~     chronic respiratory diseases, such as COPD (chronic bronchitis and emphysema), asthma, sleep~     apnea, and lung cancer. Nova Scotia has been reported to have one of the highest rates of~     chronic lung disease among Canadian provinces, likely a reflection of both the age of the~     population and high rates of exposures to occupational dusts and smoking. Pulmonary~     rehabilitation is a multidisciplinary intervention, involving exercise and education for~     patients with chronic lung disease. Pulmonary rehabilitation has been demonstrated to improve~     patient symptoms, exercise capacity, and quality of life while reducing health resource~     utilization. Many studies have shown that the benefits of pulmonary rehabilitation tend to~     diminish over time after program completion. The best interventions to maintain the benefits~     of pulmonary rehabilitation remain unclear.~      The purpose of this study is to validate incorporation of an exercise DVD into a maintenance~     program after pulmonary rehabilitation. 100 subjects will be recruited over 2-years from~     pulmonary rehabilitation programs at Capital Health, with 50 individuals randomized to usual~     care following PR and 50 individuals randomized to usual care plus the exercise DVD. Study~     subjects will be evaluated at time of enrolment in pulmonary rehabilitation, at completion of~     pulmonary rehabilitation and 6-months post- pulmonary rehabilitation. Study outcome measures~     will include exercise capacity, exercise compliance, health-related quality of life,~     confidence with performing exercise, and satisfaction with the exercise DVD. The primary~     outcome measure will be a change in functional exercise capacity as determined by the~     distance walked in 6-minutes, a commonly used and validated assessment tool for patients with~     chronic lung disease.~   "
177976|NCT01235468|"~     The aim of this study is to evaluate the safety profile and tolerability of infusion of cord~     blood cells expanded in the lab and to evaluated whether through the infusion of expanded~     cells it is possible to expedite engraftment time after transplantation.~   "
177977|NCT01235455|"~     This is an observational survey to assess the factors that influence adherence to Betaferon~     therapy in multiple sclerosis patients using elements of the BetaPlus support program,~     including the nurse support and auto-injectors. The patients were evaluated under normal~     clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping~     processes (WCQ) and depression questionnaire CES-D.~   "
177978|NCT01235442|"~     The primary hypothesis of this trial is that the addition of short courses of clobetasol~     propionate foam to etanercept monotherapy in subjects with moderate to severe plaque~     psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by~     PASI 75 at Week 12.~   "
177979|NCT01235429|"~     Type 2 diabetes is common among Native Hawaiians and Pacific Peoples. Diabetes related~     complications decrease quality of life and can result in early morbidity. The purpose of the~     Partners in Care diabetes self-management educational intervention is to teach participants~     how to manage their diabetes to avoid or delay diabetes-related complications and how to~     better work with their health care team.~   "
177980|NCT01235416|"~     This study is an open-label, dose-finding study to determine the target or maximum-tolerated~     dose and to characterize the safety and pharmacokinetic profile of AMG 706 administered in~     combination with erlotinib with or without gemcitabine in subjects with solid tumors.~   "
178021|NCT01234883|"~     The primary objective of this study is to compare the efficacy and safety of the use of a~     multiple electrolyte solution to the use of saline for the treatment of moderate to severe~     dehydration due to acute gastroenteritis (AGE) in children.~   "
177981|NCT01235403|"~     To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of~     400 mg/day, or to a clinically effective lower dose for an individual patient, improves the~     tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients~     with partial onset epilepsy.~      Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility~   "
177982|NCT01235390|"~     The purpose of this study is to determine the effects of the 4-week consumption of California~     walnuts on vascular function and immune health in postmenopausal women of ages 50-70.~      Primary outcome measures:~        -  vascular endothelial function~        -  platelet reactivity~        -  indoleamine 2, 3-deoxygenase (IDO)~      Secondary outcome measures:~        -  relationship of walnut intake to lipoprotein, fatty acids and oxylipins~   "
177983|NCT01235377|"~     This is a pilot study of a method to compare common, FDA-approved drugs in a clinic. Instead~     of putting single patients into one of two drug groups, the investigators will assign the~     doctors who prescribe these drugs for high blood pressure into two groups. One group of~     doctors has agreed to prescribe mostly (favor) one drug, chlorthalidone, if that drug would~     be a good choice for a patient. The other group has agreed to prescribe mostly~     hydrochlorothiazide. For both groups, they will try to use the doses that were shown to be~     protective in other trials. If the doctors mostly prescribe the drug they agreed to favor,~     the investigators will be able to compare outcomes, like heart attacks, in the two groups.~   "
177984|NCT01235364|"~     The purpose of this study is to assess pain in women randomised to digital or speculum~     placement of a Foley catheter. Pain during cervical ripening with the Foley catheter is also~     to be evaluated as well as maternal satisfaction with induction of labour.~   "
177985|NCT01235351|"~     To determine whether higher as compared with lower maintenance doses of clopidogrel can~     adequately improve the degree of platelet inhibition in carriers of a reduced-function~     CYP2C19 allele.~   "
177986|NCT01235338|"~     This study will examine the effects of co-administration of SPD489 and the antidepressant~     EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In~     addition, serial blood pressure and pulse measures will be obtained and examined to ensure~     that there are no unexpected changes in vital signs following co administration of SPD489 and~     EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is~     that a drug drug interaction could possibly exist.~   "
177987|NCT01235325|"~     To assess the impact of a 12 month vitamin K supplementation intervention on bone health in~     adult Crohn's disease patients~   "
177988|NCT01235312|"~     Currently, dorsal hand rejuvenation is an upcoming issue as patients seek plastic surgeons to~     address this highly visible area, although no specific statistics concerning the number of~     patients undergoing dorsal hand rejuvenation have been published yet. The solitary use of~     fillers, fat, sclerotherapy, skin excision, resurfacing and combinations of the above~     mentioned therapies have been reported in the literature, but still there is a lack of~     scientific literature about functional microcirculation of the dorsum of the hand.~      Furthermore, there is a lack of scientific data about functional microcirculation of the~     plantar foot in healthy subjects compared to patients suffering from Diabetes mellitus or~     peripheral arterial occlusive disease. Consequently, the aim of this study is the evaluation~     of the functional microcirculation of hands and feet in healthy subjects as well as patients~     suffering from the above mentioned diseases.~   "
177989|NCT01235299|"~     In case of free flap failure, time is of utmost importance as salvage rates have been~     reported to be inversely related to the time interval between the onset of ischemia and its~     clinical recognition. Consecutively, monitoring of free flaps remains of major importance.~     Currently, combined Laser-Doppler and Spectrophotometry is available to determine~     microcirculation of free flaps in reconstructive surgery as a scientific method of reliable~     assessment of flap perfusion. The investigators thought to analyze the correlation of free~     flap skin temperature and free frap microcirculation as an accurate tool of postoperative~     flap monitoring.~   "
177990|NCT01235286|"~     Background: In plastic and reconstructive surgery, free flaps are routinely used for~     treatment of soft tissue defects. Treatment strategies aim at reducing or preventing flap~     necrosis by conditioning tissue tolerance against ischemia. Although previous studies~     indicate that remote ischemic preconditioning (RIPC) is a systemic phenomenon, only a few~     studies have focused on the elucidation of its mechanisms of action. Therefore, the aim of~     this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on~     a potential free flap location in a human in-vivo setting for the first time.~      Conclusion: Remote ischemic preconditioning improves cutaneous tissue oxygen saturation,~     arterial capillary blood flow and postcapillary venous flow in a remote free flap donor~     location. To what extent remote preconditioning might ameliorate the reperfusion injury of~     free flap transplantation, further clinical trials have to evaluate both in the means of~     microcirculatory assessment and partial or total flap loss as end points of these studies.~   "
177991|NCT01235273|"~     The objective of the study is to determine whether treatment of the low IGF-1 syndrome in~     patients with CHF is able to modify some functional parameters, recognized as valid surrogate~     end-points of CHF progression.~   "
177992|NCT01235260|"~     The purpose of this study is to evaluate risk of cancer incidence and mortality associated~     with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S.~     Veterans Health Administration.~   "
177993|NCT01235247|"~     Computer-generated clinical reminders offered to providers will improve compliance with care~     guidelines and impact outcomes in resource-limited clinics.~   "
177994|NCT01235234|"~     Eligible patients with dry eye will be treated with CF101 or placebo twice daily for 24~     weeks. Disease activity will be assessed using evaluations of ocular surface integrity, tear~     production, and patient symptoms.~   "
177995|NCT01235221|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple~     sclerosis (MS) who previously participated in the registrational and extension studies~     conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT)~     and NCT00649792 (MS-F204EXT).~   "
178035|NCT01234701|"~     The purpose of this multicenter study is to evaluate the agreement among expert radiologists~     in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in~     non-cirrhotic patients.~   "
177996|NCT01235208|"~     The background for the trial is a number of previous studies indicating that it is especially~     important to restrict the intake of carbohydrates when treating overweight and metabolic~     diseases in general.~      The purpose of the study is to obtain research data on the effects of an established~     treatment of overweight/obesity and its related metabolic disorders. The treatment, Dr.~     Fedon Lindbergs Vektcoach, is a combination treatment where patients use low carbohydrate~     and low energy Eurodiet products in the initial phases. After the initial phases are~     completed, low glycemic normal foods are added to the diet until a sustainable and healthy~     diet is achieved. The treatment is of 7 month duration.~   "
177997|NCT01235195|"~     This study is designed to determine differences in drug exposure in subjects after being~     administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after~     administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.~   "
177998|NCT01235182|"~     Acute heart failure is one of the main causes of acute respiratory distres in prehospital~     emergency setting. The early and correct diagnosis is important because the misdiagnosis can~     result in deleterious consequeance to patients. Rapid bedside tests (like NT-proBNP) and~     point-of-care lung ultrasound could be useful methods in field. This study confirmed that the~     combination of ultrasound sign in combination with rapid NT-proBNP test has a hibh diagnostic~     accuracy in differentiating between cardiac and pulmonray causes of acute dyspnea in the~     field and the tretament possibilities in clinical obscure cases are mainly improved.~   "
177999|NCT01235169|"~     This is an open multicenter study, evaluating a new operative technique in femur neck~     fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter~     fracture due to osteoporosis.There two routine surgical techniques in femoral neck fractures:~        1. Insertion an intramedullary nail (without augmentation) to the bone.~        2. insertion a nail and metal plateto the bone. The major disadvantage of these methods is~          the relative high rate (4-10 precentages) of failure because of the femur head bone~          which is very brittle and osteoporotic.~      This new approach enables the nail a better grip as a result of the cement augmentation which~     consists of PMMA (Polymethyl methacrylate).~      The investigators main goal is to evaluate the use of this surgical technique~   "
178000|NCT01235156|"~     Arrhythmia is a common disease that may be caused by various cardiovascular diseases.~     According to statistics, 500,000 people die of severe arrhythmia every year in China, In the~     United States, approximately 540,000 patients die each year.This study will evaluate the~     effectiveness safety of sulcardine sulfate tablets in the patients with premature ventricular~     contractions (and non-sustained VT).~   "
178001|NCT01235143|"~     Sevoflurane is the volatile anesthetic agent of choice in pediatric surgery. Nevertheless,~     sevoflurane anesthesia had the high incidence of emergence delirium compared to halothane and~     isoflurane.Bortone L et al.reported isoflurane for maintenance decreased incidence of~     emergence agitation compared to sevoflurane in unpremedicated preschool children under~     elective subumbilical surgery (32% versus 52% respectively). Desflurane is the new volatile~     anesthetic agent which provides faster recovery compared to sevoflurane.Valley et al.reported~     no significant differences between sevoflurane or desflurane anesthesia in children in term~     of the serious airway complication such as laryngospasm or desaturation excepted the number~     of coughing episodes were more frequent in the desflurane compared to sevoflurane (36 versus~     18).Mayer J et al. reported sevoflurane had severity of Pediatric Anesthesia Emergence~     Delirium (PAED) scale higher than desflurane in ear, nose, throat inpatient surgery in~     children (12(2-20) versus 6(0-15) respectively) with no reported of incidence of emergence~     agitation between those two. Therefore, the investigators would like to compare the incidence~     of emergence agitation, recovery profile and respiratory events between desflurane and~     sevoflurane anesthesia in pediatric ambulatory urologic surgery under general anesthesia and~     combined with regional anesthesia.~   "
178002|NCT01235130|"~     The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids,~     2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal~     or persistent AF in whom a rhythm-control strategy is planned.~   "
178003|NCT01235117|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying the side effects of azacitidine and to see how well~     it works in treating patients with chronic myelomonocytic leukemia.~   "
178004|NCT01235104|"~     The aim of this study is to investigate the outcomes of total nephrectomy on patients with~     kidney stone disease.~   "
178005|NCT01235091|"~     Women Teaching Women (WTW) is proposed by a team of Washington University investigators who~     have focused on HIV prevention efforts among out-of-treatment injecting drug users (IDUs) and~     crack cocaine users, since 1988. Our peer-delivered prevention model was successful in~     reducing cocaine use among men. The investigators believe no differences were found in drug~     and sexual risk behaviors for women because the intervention lacked gender-specificity. Thus,~     the investigators propose to tailor our previous intervention to women's needs to determine~     the shorter and intermediate term effectiveness of a gender-specific model on reducing drug~     use and sexual risks. The urgency for women-focused interventions is highlighted by~     increasing HIV/STD rates among women nationwide. The intervention is designed to bring the~     HIV prevention message to women in a public health environment. The three-arm intervention,~     which targets out-of-treatment drug-using women, will assess the differential impact of a~     woman-centered standard intervention alone, the same standard intervention plus a well-woman~     exam, and those plus the addition of 4 educational sessions. This proposal responds to two~     NIDA PAs: 95-083 (Women's HIV Risk and Protective Behaviors) and 96-018 (Drug Abuse~     Prevention Intervention for Women and Minorities). Our risk reduction, epidemiological and~     technology transfer aims include:~      Risk Reduction Aims:~        1. Recruit out-of-treatment female drug injectors, heroin, crack/cocaine and~          methamphetamine users to into an intervention aimed at reducing high risk sexual and~          drug use behaviors. Street outreach, bars and clubs, shelters, health fairs and daycare~          facilities will be used to reach these vulnerable women at risk.~        2. Administer a modified theory-based, peer-delivered, gender and culture-specific~          intervention that encourages women to reduce their high risk drug and sexual behaviors.~          Women will be randomly assigned to one of three peer-delivered interventions: a modified~          NIDA Cooperative Agreement Standard Intervention (SI), the SI + Well-Woman Exam~          (SI+WWE), or the SI+Well-Woman Exam + 4 Educational Sessions (SI+WWE+4ES). The Standard~          Intervention will be delivered by peers; the Well-Woman Examination will be conducted by~          a nurse practitioner; the four 2 hour educational sessions will be conducted by peer~          facilitators from area drug treatment programs paired with a community mental health or~          health professional.~        3. Assess the effectiveness of the interventions in reducing drug and sexual risk at 4 and~          12 months post-intervention, controlling for baseline characteristics.~        4. Evaluate the relative cost-effectiveness of each intervention.~           Epidemiologic Aim:~        5. Assess: a) incidence of HIV, Hepatitis B and C, syphilis, chlamydia and gonorrhea 12~          months post-intervention; b) change in HIV risk and drug and alcohol use at 4 and 12~          months post-intervention; c) the effect of psychopathology on behavior change at 12~          months post-intervention; d) lifetime history of substance abuse and service utilization~          for mental and physical problems at baseline.~           Technology Transfer Aim:~        6. Disseminate findings to the scientific community, practitioners and community members in~          formats that are appropriate, understandable, and usable in order that the best possible~          women-centered intervention can be developed for reducing HIV risk behaviors. The~          investigators propose to create a WebSite and present findings at local, national and~          international symposia. Manuals describing the interventions will be developed and made~          available to the field.~   "
178006|NCT01235078|"~     The purpose of this study is to evaluate the use of powered intraosseous vascular access~     (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular~     access. Data collected will be compared to historical data on central venous catheter use in~     the emergency department. The primary hypothesis is that powered intraosseous vascular access~     will decrease the amount of time needed to obtain vascular access.~   "
178007|NCT01235065|"~     The purpose of this study is to assess if the GlideScope video laryngoscope is superior to~     the Macintosh direct laryngoscope for definitive airway management in acutely-injured~     patients.~   "
178008|NCT01235052|"~     Head and neck cancer is the sixth most frequent cancer worldwide, excluding lymphomas and~     skin cancer. If 18FDG PET is considered today as a standard tool in patients with head and~     neck squamous cell carcinoma (HNSCC) not only for tumoral or nodal staging but also for~     assessment of distant metastases and synchronous second primary malignancies, hypoxia is one~     of the most important prognostic factors in radiotherapy of this type of tumors. The only~     gold standard method for direct determination of oxygen tension is based on using oxygen~     electrodes showing a good relation with clinical outcome but complex in its realisation. So,~     PET using 18F-FMISO has been described to be useful for the non invasive assessment of~     hypoxia in cancer. Especially in France, the use of this radiotracer is very limited and~     there is no standardised methodology to acquire and quantify 18F-FMISO signal. So there is a~     need for a rigorous evaluation of this PET tracer. In another way, it could be a very useful~     tool for evaluation of new therapies and modification of volumes in radiotherapy.~   "
178009|NCT01235039|"~     The primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25~     and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7~     with those of VIAject®25 and insulin lispro.~   "
178010|NCT01235026|"~     The purpose of this study is to determine whether the daily administration of a synbiotic~     (oligofructose and Bifidobacterium animalis subsp. lactis Bb12) for six weeks contributes to~     improve the glucose tolerance and the low grade inflammation (as reflected as the plasmatic~     concentrations of ultrasensitive CRP, IL-6, sCD14 and LPS-binding protein) in obese subjects.~   "
178011|NCT01235013|"~     Maraviroc is an antiretroviral drug that belongs to the family of the CCR5 coreceptor~     inhibitors. It has proven to be effective in increasing CD4 lymphocyte counts in both in~     treated and naïve patients, irrespective of the viral load.~      The investigators hypothesize that adding Maraviroc to the antiretroviral treatment of~     discordant patients, defined as those having CD4 lymphocyte counts below 200 cells /mm3~     during the last year, could lead to its immunological recovery.~      60 patients will be included in this unicentric, prospective, randomized and stratified~     clinical trial. They will be randomized to either continue with its usual high activity~     antiretroviral therapy (HAART) treatment or to receive 300 mg of Maraviroc every 12 hours~     plus its usual treatment. After 24 weeks, lymphocyte counts will be assessed, as well as~     safety, clinical progression, immunological profile of the patients and the potential benefit~     of Maraviroc for HIV+ cirrhotic patients.~   "
178012|NCT01235000|"~     Each winter, viruses belonging to two kinds of influenza A (A/H1N1 & A/H3N2) and two~     kinds of influenza B (B/Yamagata & B/Victoria) can cause illness. The yearly influenza~     vaccine is designed to protect against both kinds of influenza A but only one or the other~     kind of influenza B. Current recommendations in Canada are that if an eligible child less~     than nine years of age has received two doses of influenza vaccine before, then that child~     only requires a single dose of influenza vaccine in subsequent years of immunization. In a~     previous study conducted in early 2010 we measured the antibody response to influenza B in~     children who had previously received two doses of a B/Yamagata kind of virus contained in the~     2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in the~     2009-10 recommended vaccine. The purpose of this follow-up study is to see if the protection~     (antibodies in the blood) provided against the influenza B/Victoria kind of virus that was in~     the 2009-10 vaccine can be improved with another (second) dose of the same B/Victoria kind of~     virus included in the 2010-11 vaccine. Since influenza B is an illness especially of~     children, understanding how to best protect children against both kinds of influenza B is~     important.~   "
178013|NCT01234987|"~     The purpose of this study is to collect breath samples from healthy and cancer sick patients.~     The breath, collected to special bags, will be transferred to laboratories in the Technion~     and analyzed using an electronic nose system developed in Hossam Haick's labs (Chemical~     Engineering, Technion). The hypothesis is that based on the analysis of the chemical~     bio-markers present in the exhaled breath, cancer states can be distinguished from healthy~     subjects or before and after treatment, allowing a technique for diagnosis of cancer and/or~     cancer treatment.~   "
178014|NCT01234974|"~     Observe the safety/tolerability and effectiveness in terms of response rate and duration of~     response of the combination pasireotide + everolimus in the treatment of patients with~     relapsed/refractory multiple melanoma.~   "
178015|NCT01234961|"~     This project evaluates the outcomes of a work rehabilitation program, Redesigning Daily~     Occupations (ReDO), for women with stress-related disorders. The ReDO intervention focuses on~     how people compose their everyday lives. The basic idea is that re-structuring of an~     individual's lifestyle and pattern of daily occupations will lead to a healthier balance~     between the occupations of everyday life, and that this balance will promote wellness and~     increased work capacity. The program is group based and comprises 16 weeks.~      The aim is to evaluate ReDO for women with stress-related disorders. The project, which~     covers the time period from entering the program to a 12-month follow-up, is a~     quasi-experimental study. 42 women who entered the program and fitted the selection criteria~     were included. A matched comparison group was selected among those clients at the Social~     Insurance Office who get care-as-usual (CAU). Both groups are followed prospectively and~     are compared regarding return to work, sick leave, and different aspects of health and~     well-being. The hypothesis is that the ReDO group will improve more than the CAU group in all~     these respects.~   "
178016|NCT01234948|"~     The primary aim of the current study was to determine the association between halitosis~     detection (presence or absence) and periodontal status in non-smoking subjects, and also~     assess whether halitosis recordings were related to periodontal clinical parameters, tongue~     coating and quantities of two putative periodontal pathogens on the posterior region of the~     tongue determined by real-time PCR. Secondary, halitosis recordings were compared among~     subjects with chronic periodontitis, chronic generalized gingivitis and periodontal health.~   "
178017|NCT01234935|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. It is not yet known whether giving dasatinib together with~     gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating~     pancreatic cancer. PURPOSE: This randomized phase II trial is studying how well giving~     dasatinib together with gemcitabine hydrochloride works compared to giving gemcitabine~     hydrochloride alone in treating patients with pancreatic cancer previously treated with~     surgery.~   "
178018|NCT01234922|"~     RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help~     lower blood pressure.~      PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril,~     ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.~   "
178019|NCT01234909|"~     Atopic dermatitis is a chronic skin disease with pruritus as one of its main features.~     Because of the symptomatic nature of their condition, pediatric patients with atopic~     dermatitis may preferentially seek care in the subspecialty dermatology clinic while falling~     behind in visits to their primary care provider. This cross-sectional study in patients~     attending the Dermatology Clinic at Children's Hospital of Wisconsin will screen for common~     conditions associated with atopic dermatitis and subsequently treat or refer patients for~     appropriate care. The investigators hypothesize that Milwaukee County pediatric patients with~     atopic dermatitis will have a high prevalence of asthma needing treatment, missed~     immunizations requiring catch-up, and vitamin D deficiency necessitating replacement therapy.~   "
178022|NCT01234870|"~     The purpose of the study is to assess the diagnostic performance of fully automated motion~     corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected~     first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart~     disease, using coronary angiography as the reference standard. It is expected that this~     improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary~     artery disease and may obviate the need for other more expensive and invasive diagnostic~     tests currently used.~   "
178023|NCT01234857|"~     This is a two-part study that will determine, if: 1) the combination of ridaforolimus and~     dalotuzumab will improve progression-free survival compared to exemestane; and 2) the~     combination of ridaforolimus and dalotuzumab will improve progression-free survival compared~     to both ridaforolimus and dalotuzumab as single agents, in participants with breast cancer.~   "
178024|NCT01234844|"~     In -patients in a geriatric rehabilitation unit, will participate in structured therapy with~     guinea-pigs on the assumption that the therapy will reduce anxiety and improve the outcome of~     their rehabilitation.~   "
178025|NCT01234831|"~     Methicillin-resistant Staphylococcus aureus (MRSA) is endemic in hospital settings.~     Colonization with MRSA puts patients at increased risk for invasive infections, and MRSA~     infections have been associated with high costs and adverse clinic outcomes. Patients can~     clear MRSA spontaneously. Improved approaches for identifying patients who are no longer~     colonized are needed; we hypothesize that more sensitive nucleic acid amplification can be~     used to improve identification of patients who are no longer colonized.~   "
178026|NCT01234818|"~     A prospective multicenter trial has been started in Korea to investigate the treatment~     efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) in endometrial hyperplasia~     (EH) patients. The LNG-IUS is known as an alternative of oral progesterone agents without~     incurring the disadvantages of oral progestogens. Therefore, it is hypothesized that if the~     therapeutic efficacy of LNG-IUS is similar or above oral progesterone, LNG-IUS would be a~     standard treatment for the EH patients who don't want hysterectomy. LNG-IUS is inserted into~     uterus of which patients are histologically confirmed as endometrial hyperplasia. Office~     endometrial aspiration biopsy and transvaginal ultrasound is conducted every 3 months at~     outpatients The primary endpoint is response rate. Secondary endpoint is to estimate the~     consistency of the results between office endometrial aspiration biopsy and dilatation and~     curettage (D&C) procedure.~   "
178027|NCT01234805|"~     This clinical trial studies yoga therapy in treating patients with malignant brain tumors.~     Yoga therapy may improve the quality of life of patients with brain tumors~   "
178028|NCT01234792|"~     Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.~   "
178029|NCT01234779|"~     This randomized, double-blind, placebo- and active-controlled, parallel group study will~     evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute~     exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg~     or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients,~     with a 4-week follow-up period.~   "
178030|NCT01234766|"~     The purpose of the study is to learn about the safety and effectiveness of treating~     follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT)~     using 90-yttrium (Y) ibritumomab tiuxetan.~      The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly~     found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to~     the study treatment.~      Bendamustine is approved by the United States Food and Drug Administration (FDA) for the~     treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL)~     that has progressed during or within six months of treatment with rituximab or a~     rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat~     follicular lymphoma.~      Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or~     follicular, CD20-positive B-cell non-Hodgkin's lymphoma.~      90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or~     refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular~     NHL. It is also approved for the treatment of follicular NHL that is previously untreated~     with radioimmunotherapy and that achieved a partial or complete response to first-line~     chemotherapy.~      Study participants will will receive bendamustine and rituximab for up to 16 weeks. If~     participants' cancer responds well to the treatment with bendamustine and rituximab, they~     will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete,~     participants will be asked to return to the clinic every 3 months for a maximum of 10 years~     for follow-up visits.~   "
178031|NCT01234753|"~     The number of adults with congenitally malformed hearts is increasing. According to a~     prospective population-based cohort study from Sweden (1992-2001) the prevalence of~     cardiovascular defects was 9.1 per 1,000 births, which is comparable to other presented~     prevalence data in the world.On the basis of 9 million inhabitants, Sweden should have~     approximately 82000 born with CHD and approximately 20000 will, in adult age, need regular~     follow up in cardiac care. This is a result of the greater improvements within paediatric~     heart surgery and there is an increasing demand for continuous follow up in the healthcare~     system.[2] Guidelines from the European Society of Cardiology and the Canadian Cardiovascular~     Society recommend follow-up oriented towards both medical and psychosocial problems.~      Earlier studies have shown that adults with CHD have poor knowledge about their heart~     disease.The results are difficult to summarise because of the use of different instruments,~     methods and sample sizes. Most of the adults with CHD did not know their clinical diagnosis~     or what endocarditis was. However, we do not know if everyone in these studies was~     recommended endocarditis prophylactics or their definition of poor knowledge.~      At present different programmes for adults with CHD are established in hospital outpatient~     clinics. These studies describe the established programmes. They also address the needs for~     development of care e.g. a multicenter approach, transitions from paediatric to adult health~     care, delivery care in Europe, programmes for pregnancy, how to provide clinical strategies,~     health care resource utilization or outpatient nursing clinic for adults with CHD. But there~     is a lack of knowledge regarding how education and psychosocial support should be given to~     adults with congenitally malformed hearts and what effects that can be achieved. The aim is~     to evaluate the effects of a nurse-led intervention consisting of education by a~     computer-based educational programme and psychosocial support to adults with congenitally~     malformed hearts.~   "
178032|NCT01234740|"~     RATIONALE: Bafetinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This clinical trial studies bafetinib in treating patients with recurrent high-grade~     glioma or brain metastases.~   "
178033|NCT01234727|"~     A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system~     commercially available in Germany & Holland.~   "
178034|NCT01234714|"~     The purpose of this study is to objectively quantify liver fat content (LFC) by Magnetic~     Resonant Imaging (MRI) prior to major liver surgery, and to investigate its association with~     post-operative complications.~   "
178037|NCT01234675|"~     Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most~     of the patients with fibromyalgia complain of either non-restorative sleep or complaints of~     disturbed sleep due to pain. The proposed study is aimed at examining the effects of~     milnacipran on sleep disturbance in patients with fibromyalgia. The study is randomized,~     double-blind, placebo controlled, two way crossover PSG study to explore the effects of~     milnacipran on sleep disturbance. Patients will receive either milnacipran 50 mg BID or~     matching placebo.~   "
178038|NCT01234662|"~     To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural~     anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain~     after elective cesarean section.~   "
178039|NCT01234649|"~     A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future~     health of the mother. GDM is often the culmination of years of unrecognized and unmodified~     diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy.~     Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will~     develop type 2 diabetes (DM2) at rates much greater than control groups who did not have~     glucose intolerance during pregnancy. Liraglutide may potentially delay disease progression~     in GDM considering the beta -(ß-)cell function improvement in DM2 and ß-cell mass shown to~     increase in animal models. This study will examine if the addition of liraglutide to~     metformin therapy is more effective than metformin alone in improving insulin sensitivity and~     normalizing insulin secretion in at-risk overweight/obese women with prior GDM.~   "
178040|NCT01234636|"~     Cardiovascular disease is a major cause of mortality worldwide resulting in one out of three~     global deaths. One of the main characteristics of cardiovascular disease is impaired blood~     flow and increased formation of clots. Platelets are clot-forming cells responsible for~     prevention of bleeding. However, in disease state they may be overly activated and tend to~     stick to each other, promoting blood clots and blockage of vessels.~      Conjugated linoleic acids (CLA) are unique fatty acids present in dairy food products and~     beef which would help to prevent platelets from clotting and thus help to prevent~     cardiovascular disease. However, the mechanisms by which those fatty acids affect platelet~     function are not yet fully understood. We designed a human intervention study assessing the~     mechanisms by which CLA beneficially affect platelet function and markers of haemostasis and~     inflammation in humans.~   "
178041|NCT01234623|"~     Human autologous serum (AS) eye drops have been successfully used in the treatment of severe~     ocular surface disorders and the enhancement of corneal wound healing, due to their growth~     factor (GF) content. Umbilical cord serum (UCS) contains even higher GF concentrations and~     the objective of the study was to prove whether UCS eye drops~        1. are effective in the healing of corneal epithelial defects.~        2. ameliorate the painful subjective symptoms~   "
178042|NCT01234610|"~     An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta,~     which is a large blood vessel in the abdomen. Large AAAs (>55 mm diameter) carry a high risk~     of rupture, a surgical emergency that often leads to death due to severe internal bleeding.~     It has been suggested that regular exercise training might limit the rate at which AAAs~     develop. However, little is known about the safety and effectiveness of exercise training in~     these patients. This pilot study will examine the feasibility of supervised aerobic exercise~     training for patients with small AAAs (30 to 49 mm diameter). The investigators hypothesize~     that exercise training will be safe and useful for patients with small AAAs.~   "
178043|NCT01234597|"~     Primary Objective:~      To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose~     monitoring, on glucose control in type 2 diabetes patients who are not controlled by~     treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus~     regimen~   "
178044|NCT01234584|"~     The purpose of this present study is to compare alveolar bone changes and markers of gingival~     health around the new Lanes® dental implant which were rehabilitate using the new switch~     platform abutment ( SPR ) and the traditional ( CPK ) abutment.~   "
178045|NCT01234571|"~     Remodulin (Treprostenil sodium) is synthetic prostacyclin analog available as a solution for~     administration in the intravenous route. It is approved for treatment of class I - pulmonary~     hypertension functional capacity stage III-IV. A key factor for the success of pulmonary~     hypertension therapy is maintaining near constant blood level of a given medications along~     the day. A sudden decrease in the blood levels might lead to rebound phenomenon; abrupt~     increase in the pulmonary artery pressure which might lead to acute right ventricular failure~     and even to sudden death. As some PHT patients suffer are on hemo-dialysis therapy due to~     end-stage renal disease there is a need to document the variation of the blood level along~     the dialysis cycle.~   "
178046|NCT01234558|"~     The purpose of this study is to determine whether GLYX-13 reduces depression score in~     patients with treatment-resistant depression.~   "
178047|NCT01234545|"~     This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy~     of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant~     human factor VII) in patients with haemophilia A and B patients with inhibitors.~   "
178048|NCT01234532|"~     This phase II trial is studying how well giving entinostat and anastrozole together works in~     treating postmenopausal women with triple-negative breast cancer that can be removed by~     surgery. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells.~     Giving entinostat together with anastrozole may be an effective treatment for breast cancer.~   "
178049|NCT01234519|"~     The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients~     with a tumor of the urinary system.~   "
178058|NCT01234389|"~     Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general~     population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and~     gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen~     tests, histology or the Helicobacter urease test (HUT).~      The aim of our study is to access the clinical reliability of a new, electrochemical device~     for rapid H. pylori detection.~   "
182913|NCT01170611|"~     This clinical investigation is a prospective, single-blinded, randomized trial. The primary~     objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive~     algorithms.~   "
178050|NCT01234506|"~     A major means whereby oxidative stress promotes aging-related disease is by activating~     inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many of~     the problems associated with aging, including vascular dementia, Alzheimer's disease,~     osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome.~     Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein~     inducers decrease oxidative stress and associated inflammation. The flax lignan~     secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2~     protein inducer. Animal and human studies have shown that consumption of flax seed or its~     component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of~     experimentally-induced cancers as well as metastases of human breast tumours implanted into~     nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in~     modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and~     exerting control over cell differentiation. Adequate levels of vitamin D also appear to~     promote better glycemic control. The investigators predict that consumption of SDG in persons~     with adequate vitamin D status will decrease oxidative stress and associated inflammation. If~     this hypothesis is upheld, this research has the potential to greatly decrease healthcare~     costs while allowing healthier aging.~   "
178051|NCT01234493|"~     The aim of our study was to determine whether transfixation of unstable syndesmosis is~     necessary in supination-external rotation type ankle fractures. Our hypothesis was that~     syndesmotic ligaments heal at the proper length after malleolar reduction and that~     syndesmotic transfixation is not needed in supination-external rotation fracture types.~   "
178052|NCT01234467|"~     The purpose of this research study is to learn about the safety of the treatment with a~     combination of bendamustine and rituximab and to find out what effects, both good and bad~     this treatment has on DLBCL. In addition to learning about the combination of bendamustine~     and rituximab, the researchers are interested in learning about how this cancer treatment~     affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA). GAs~     are designed to gather information on memory, nutritional status, mental health, and level of~     social support. GAs are also designed to help the health care team understand how well~     subjects can carry out their day to day activities and to briefly describe what other medical~     conditions subjects may have. This assessment will help the health care team understand a~     subject's functional age (the age a subject functions at) as compared to a subject's actual~     age.~      The researchers also want to learn how chemotherapy affects the aging process in our bodies.~     This is done by measuring the amount of p16 in blood. Researchers want to understand if~     chemotherapy changes the levels of p16 in blood.~   "
178053|NCT01234454|"~     The general aim is to compare the effects of typical and atypical antipsychotic medication on~     brain structure and function. A parallel group treatment trial will be utilized to compare~     the effects of the typical antipsychotic thiothixene versus the atypical antipsychotics~     risperidone (RIS) and olanzapine (OLZ) on brain structure and function in schizophrenia in an~     effort to determine the neuroanatomic basis for cognitive pathology in schizophrenia and its~     amelioration by atypical antipsychotic drugs.~   "
178054|NCT01234441|"~     Chronic kidney disease (CKD) patients receiving hemodialysis treatment (CKD stage 5) suffer~     from a variety of co-morbid diseases, many of which may be mechanistically linked. Protein~     malnutrition, muscle catabolism and wasting are especially common, and these lead to reduced~     muscle strength, declines in physical function, and low levels of physical activity. Physical~     inactivity exacerbates these functional declines, and also promotes cardiovascular disease~     (CVD) and bone disorders. This cycle of disease and disability greatly reduces quality of~     life (QOL) and increases mortality rates in dialysis patients.~      Many factors contribute to the development of these co-morbidities. Chronic inflammation is~     believed to be a cause and a consequence of the protein malnutrition, CVD and bone disorders~     in dialysis patients. In addition, abnormalities in mineral metabolism resulting from the~     deficit in kidney function promote the loss of mineral from bone and the deposition of~     mineral in the vasculature, a process termed vascular calcification (VC). VC is associated~     with a variety of CVD-related disorders, including arterial stiffness, increases in arterial~     wall intima-media thickness (IMT), left ventricular hypertrophy (LVH), and declines in~     cardiac function. As a result of these abnormalities, cardiovascular events are 10 to 30~     times greater in dialysis patients than in age- and sex-matched subjects in the general~     population.~   "
178055|NCT01234428|"~     The purpose of this study is to determine whether esophageal dysmotility and dilatation is an~     important complication in the long term follow-up following laparoscopic gastric banding for~     morbid obesity.~   "
178056|NCT01234415|"~     The aim of this project is to evaluate the safety and efficacy of the biomaterial made of~     HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this~     biomaterial will avoid the graft sampling and we expect it to be a good substitute to support~     the nasal pyramid while favouring the respiratory epithelium regeneration. Thus, that would~     confirm previous in vitro and in vivo studies.~   "
178057|NCT01234402|"~     An open-label, multicenter, randomized, Phase 2 trial in which patients with unresectable,~     locally advanced or metastatic breast cancer who have been previously treated with~     anthracycline and taxane therapy receive ramucirumab DP or IMC-18F1 administered on an~     every-21-day cycle (in combination with oral capecitabine therapy; capecitabine is~     administered twice a day on Days 1-14 of each cycle). Approximately 150 patients will be~     randomized in a 1:1:1 ratio to either ramucirumab DP or IMC-18F1 in combination with~     capecitabine (Arm A and Arm B, respectively) or capecitabine monotherapy (Arm C).~     Randomization will be stratified by triple-negative receptor status (estrogen~     receptor-negative, progesterone receptor-negative, and human epidermal growth factor~     receptor-2 [HER2/neu]-negative) (yes/no) and receipt of prior antiangiogenic therapy.~      Treatment with the study medication(s) will continue until disease progression, the~     development of unacceptable toxicity, noncompliance or withdrawal of consent by the patient,~     or investigator decision. Capecitabine dose reductions in the setting of significant~     myelosuppression, hand-and-foot syndrome, or diarrhea will be required.~   "
178107|NCT01233752|"~     Identification of the genetic polymorphisms that could be correlated either with a better~     clinical response or with a major predisposition of patients to develop tolerance and/or side~     effects to the treatment with morphine.~   "
178059|NCT01234376|"~     Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of~     the gut at a subcellular resolution. Various studies have addressed the potential of~     endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s~     esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our~     group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic~     esophagitis.~      The purpose of this study is to determine whether endomicroscopy is effective for the in vivo~     diagnosis of eosinophilic esophagitis.~   "
178060|NCT01234363|"~     The purpose of this study is to assess the potential of elastography for noninvasive~     assessment of fibrosis in renal allograft.~   "
178061|NCT01234350|"~     This study is a large observational study set-up to observe how the long-term treatment of~     Firmagon (hormone regulator) compared to another treatment will effect specific conditions~     such as cardiovascular events, changes in bone density, changes in blood sugar levels or~     liver enzyme levels in patients with prostate cancer. Patients will be treated according to~     their routine clinical care and this will not be dictated by the study. As the study is~     observational in nature, the study will collect specific data relating to the 3 specific~     events above. Patients that agree to this study will be followed-up for 5 years. Patient data~     will be collected every 3 months for the first 2 years and every 6 months for the last 3 yrs.~   "
178062|NCT01234337|"~     The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in~     combination with capecitabine versus capecitabine in combination with placebo in the~     treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are~     resistant to or have failed prior taxane and an anthracycline or for whom further~     anthracycline therapy is not indicated. After signing consent there can be up to 28 days~     before starting the treatment during which time a number of tests will be carried out which~     will include tumor evaluations and medical history. The following tests and evaluations will~     have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the~     end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a~     complete physical exam and vital signs. Treatment will be given in 21 day cycles with~     sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the~     first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every~     cycle after the first 2 cycles. During the weekly visits the subjects will be check for any~     side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will~     be followed for overall survival.~   "
178063|NCT01234324|"~     That panitumumab in combination with Epirubicin, Cisplatin and Capecitabine (ECX) will safely~     decrease the frequency of pT3/T4 below that of ECX alone in subjects with locally advanced~     adenocarcinoma of the stomach and gastroesophageal junction.~   "
178064|NCT01234311|"~     This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in~     asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of~     tasquinimod on delaying disease progression compared with placebo.~      Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1~     ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day;~     n=800) or Treatment Group B (placebo; n=400).~   "
178065|NCT01234298|"~     To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to~     placebo when given as adjunctive therapy to antipsychotic medication in clinically stable~     adults with persistent predominant negative symptoms of schizophrenia.~   "
178066|NCT01234285|"~     Sepsis is a syndrome comprised of a systemic inflammatory response, signs of tissue~     hypoperfusion, and organ in the setting of presumed infection. Heparin, in addition to being~     an anticoagulant, is also a well-known antiinflammatory. The investigators believe that~     unfractionated heparin has the potential to save the lives of septic patients at a~     drastically reduced cost. This is a dose escalation study to determine the safety of~     increasing levels of heparin in this patient population; compare markers of anticoagulation~     and inflammation between treatment groups; and compare clinical outcomes between groups.~   "
178067|NCT01234272|"~     The present study was designed to assess analgesic capacity of intrathecal administration of~     morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared~     to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients~     undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable~     analgesic effect to PCEA in gastrectomy.~   "
178068|NCT01234259|"~     Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis~     and hypodermis.~      Radio-frequency (RF) devices have been used for many years for a variety of surgical~     applications. The energy delivery systems of these established monopolar devices used a~     'conductive coupling' delivery system in which energy is concentrated at the periphery of the~     electrode.~      Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and~     temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides~     and cellulite, the treatments creates enough thermal effect to induce collagen remodeling~     with no ablative thermal damage in the epidermis or dermis.~   "
178069|NCT01234246|"~     In this project the main focus is on assessing sexual functioning and the quality of sexual~     life after the treatment of colorectal cancer in patients and their partners.~      Patients and their partners complete questionnaires concerning sexual functioning, quality of~     life, body image, fatigue, anxiety, depressive symptoms, personality factors, and demographic~     factors. Questionnaires are completed before surgical treatment, 6 weeks, 3 months, 6 months,~     and 12 months after diagnosis.~      The results of this prospective study will give insight in 1) the incidence of sexual~     problems and the extent patients with colorectal cancer and their partners are bothered by~     these problems across time, 2) the effect of different treatment modalities on sexual~     functioning, 3) the relation between sexual problems and quality of life, 4) the determinants~     of sexual problems and the quality of sexual life adopting the biopsychosocial approach of~     patients with colorectal cancer who have been treated with surgery, radiation and/or~     chemotherapy, and more specifically to the role of personality and patient factors and sexual~     functioning/the quality of sexual life.~   "
178108|NCT01233739|"~     Patients who present rhizarthrosis diagnostic will be randomized to be treated with~     chondroitin sulfate or placebo during 24 weeks to study the effect of the treatment with~     objective and subjective indicators of pain and sensibility.~   "
178070|NCT01234233|"~     The investigators want to evaluate the effect of prewarming on the rate of postoperative~     hypothermia and shivering and to compare sublingual versus tympanic temperature assessment~     during the perioperative period in patients.~      Patients will be randomly assigned to 4 groups with different duration of prewarming. Body~     temperature will be recorded regularly by sublingual and tympanic (by thermocouple)~     measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed~     postoperatively.~   "
178071|NCT01234220|"~     The AVIS Study is a retrospective multicenter international study that aims to answer a~     series of questions on the use and performance of adrenal venous catheterization (AVS) for~     the diagnosis of primary hyperaldosteronism subtype. A questionnaire will be circulated among~     the centres that are internationally recognized and have published in the field of AVS and~     have agreed to participate in the study.~      The first aim of the AVIS study is to collect summary data on how AVS is being performed~     throughout the world to answer the following questions:~        -  How many AVS studies haw been performed yearly from 2005 to 2010 at each center?~        -  How many adrenal vein ruptures occurred during the AVS at each center?Has the rate of~          adrenal vein rupture been steady or has it changed over the 5 years?~        -  How many centers use bilaterally simultaneous and how many use sequential AVS~          catheterization?~        -  How many radiologists perform AVS at each center?~        -  How many centers use a cosyntropin stimulation during AVS?~        -  What is the percentage of PA patients in whom AVS is performed?~        -  How many centres calculate the selectivity index? What is the minimum cutoff used?~        -  How many centers calculate the lateralization index? What is the minimum cutoff used?~        -  Are the AVS studies that are not bilaterally selective used for diagnosis?~        -  How many centers calculate the controlateral suppression index and what is the minimum~          cutoff used?~        -  What is the cost of AVS for the National Health System or Insurance and for patients?~          The second aim of the study is to calculate the rate of AVS studies that are selective~          and show lateralization of aldosterone excess at each center by applying predefined set~          of criteria for defining selectivity and lateralization. Data on the final diagnosis of~          the PA subtype will be gathered and used as reference to assess the performance of AVS~          using receiver operating characteristic curves analysis and the Youden index to~          determine the optimal cutoffs. A worksheet will need to be completed providing~          information on the following: Demography; Date of AVS;Baseline blood pressure (BP)~          values and serum K+;Dynamic test during the AVS if any; plasma aldosterone and cortisol~          concentration in the infra-adrenal inferior vena cava and in the right and left adrenal~          vein; diagnosis of PA subtype; treatment (adrenalectomy or pharmacological therapy);~          post-treatment BP and serum K+ values; concordance/discordance between imaging (CT or~          RM) and AVS.~   "
178072|NCT01234207|"~     The purpose of this study was to compare objective clinical measures of visual performance~     and subjective measures of satisfaction and preference between standard progressive addition~     lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL~     spectacle.~   "
178073|NCT01234194|"~     The purpose of the study is to determine if the new Composite Variability Index (CVI) is~     capable of detecting changing effect compartment concentrations of remifentanil. In addition,~     it is planed to detect if the change in CVI in response to a standardized painful stimulus is~     dose-dependent.~   "
178074|NCT01234181|"~     The purpose of this study, is to determine the differences of clinical outcomes between~     hypoxic pre-treatment group and control group in bone marrow stem cell transplantation~     (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both~     treatments. Heart failure patients underwent PCI treatment after AMI and with informed~     consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic~     pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into~     patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected;~     echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive~     myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We~     hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be~     reversed in heart failure patients.~   "
178075|NCT01234168|"~     The purpose of the protocol is to to assess subject's overall satisfaction regarding control~     of diarrhea. The study aims to supplement results obtained through clinical trials with data~     obtained from a population of patients receiving treatment with Somatuline Autogel in routine~     practice.~   "
178076|NCT01234155|"~     The purpose of this study is to assess whether 4-months of interval-walking exercise training~     improves glycemic control in individuals with type 2 diabetes mellitus. The effects of~     interval-walking training will be compared to continuous-walking exercise in a randomised,~     controlled trial design. Changes in glycemic control will be examined using oral glucose~     tolerance tests (OGTT) with stable isotope methodology. In addition, insulin sensitivity and~     secretion will be examined using glucose clamps combined with glucagon-like peptide 1 (GLP-1)~     and glucose-dependent insulinotropic polypeptide (GIP).~   "
178077|NCT01234142|"~     This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a~     varenicline patch applied once daily to the skin for 14 days.~   "
178078|NCT01234129|"~     Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.~   "
178079|NCT01234116|"~     Objective: The objective of this study is to determine the safety and tolerability of~     Post-exposure Prophylaxis (PEP) with a regimen of Truvada + Kaletra among health care workers~     (HCWs) at Henry Ford Hospital.~      Hypothesis: Raltegravir is safe and better tolerated compared with Kaletra, each in~     combination with Truvada, as assessed by review of completion rates of PEP and also review of~     completed safety data.~   "
178080|NCT01234103|"~     Health damaging (risk) behaviors of young military personnel are reflections of health~     problems facing all young people in the U.S. Military life presents opportunities and~     challenges that may both protect against and place young troops at risk for health damaging~     behaviors. Challenges for maintaining a healthy armed force include high rates of sexually~     transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other~     substances. The common thread through these negative health outcomes is volitional behavior.~     Such behaviors do not only result in illness or injury, but also negatively impact~     performance of military duties and threaten military readiness. Despite military leadership~     in setting standards and policies regarding professional behavior and universal health care~     for preventing and eliminating such negative health outcomes, many health problems remain.~     Building on our previous military research, we will evaluate the effectiveness a~     cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk~     for and acquisition of STIs and UIPs and will seek to reduce a number of their associated~     risk factors including, alcohol misuse, other substance use, and victimization due to IPV in~     male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in~     Fort Jackson, SC.~   "
178109|NCT01233726|"~     The aim of the study is to evaluate the beneficial effects of the administration of a~     complete diet rich in monounsaturated fatty acids (MUFA) and slow absorption carbohydrate in~     patients with stress hyperglycemia(T-Diet Plus Diabet IR).~      The main objective of this project is to evaluate blood glucose metabolic control, insulin~     requirements, insulin action resistance, lipid profile and to reduce infectious complications~     on mechanical ventilation ICU (intensive care unit) patients after the administration of a~     complete diet enriched in MUFA and slow absorption carbohydrates, without fructose.~   "
178081|NCT01234090|"~     This prospective cohort study hypothesizes that an analysis of parallel qualitative and~     quantitative data is necessary to examine the full experience of living with aphasia. It is~     also hypothesized that there are specific factors that act as barriers or facilitators to~     successfully living with aphasia. A unique aspect of the project is the use of the Assessment~     for Living with Aphasia (ALA), a new aphasia friendly measure based on the World Health~     Organization International Classification of Functioning, Disability and Health (WHO ICF).~     Each session will assess written and spoken language, functional communication, mobility,~     Activities of Daily Living (ADL) function, burden of stroke, quality of life, and depression.~   "
178082|NCT01234077|"~     Research study that will test a portable device (CPC M1) that records: body movement; heart~     activity (ECG; snoring; and body position during sleep. The Food and Drug Administration~     (FDA) has not approved this device for use except in a research setting.~      The purposes of this study are to: a) determine if the ECG data collected using the CPC M1~     device is at least as good as the ECG data collected during a diagnostic, in-lab~     polysomnogram (PSG) (or sleep study) and b) determine if in-home monitoring with the device~     will provide similar results compared to an in-lab PSG.~   "
178083|NCT01234064|"~     This is a pilot substudy to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2), to~     assess the feasibility of adding graduated compression stockings (GCS) to POISE-2 as an~     intervention.~   "
178084|NCT01234051|"~     1. Goals~             -  The primary goal of this phase II trial is to:~           evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in~          patients with locally advanced or metastatic BTC as first-line therapy~           Secondary goals are to:evaluate the treatment-related toxicities of this combination,~          investigate progression-free survival (PFS) and overall survival (OS) in this population~        2. Design~      The proposed clinical trial is an open label, non-comparative, multicenter phase II trial~     according to the two stage testing design by Simon.22~   "
178085|NCT01234038|"~     The purpose of this study is to examine the overall survival of patients with Stage IV~     non-small cell lung cancer (NSCLC) treated with ISIS EIF4E Rx in combination with carboplatin~     and paclitaxel.~   "
178086|NCT01234025|"~     The purpose of this study is to examine the safety, tolerability and progression-free~     survival of patients with Castrate-Resistant Prostate Cancer treated with ISIS EIF4E Rx in~     combination with docetaxel and prednisone.~   "
178087|NCT01234012|"~     The purpose of this study is assess the safety of administering repeated doses of IMF-001, a~     vaccine, to patients with solid tumors that express NY-ESO-1 antigen. If the vaccine is~     therapeutically useful, a second goal is to establish the maximum therapeutic dose to treat~     patients with NY-ESO-1 positive cancers.~   "
178088|NCT01233999|"~     The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is~     a painful condition in which cold surroundings or stressful events trigger pain, a cold~     sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think~     that RP results from problems with some of the components of the blood vessels, surrounding~     nerves, and some of the circulating messengers in the bloodstream. Although there are many~     different medicines that are currently used to treat RP, the investigators have not yet found~     a cure for severe cases of this condition. Furthermore, the investigators have found few~     medicines that show consistent healing of the ulcers that may be associated with RP. Some of~     the treatments include medicines that are used to treat high blood pressure known as calcium~     channel blockers. Medications that thin the blood (anticoagulants) such as aspirin have also~     been used to treat RP.~      In this study, the investigators will investigate a new treatment for RP known as Botulinum~     toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been~     approved by the government for the treatment of several other conditions including but not~     limited to: excessive sweating, neck pain associated with a condition known as cervical~     dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a~     condition known as strabismus in which the eyes are not in alignment with one another.~      This study will aim to greatly improve the quality of life and pain associated with RP.~     Previous studies also support the chance that Botulinum toxin will help to heal some of the~     ulcers associated with RP. Although there is no current standard of care, many of the~     patients in the study will have already failed or are unable to tolerate commonly used~     treatments such as lifestyle modifications, calcium channel blockers, nitroglycerin, and~     anticoagulants. If the patient chooses to participate in the study, he/she will be randomly~     assigned to receive an injection with Botulinum toxin in either the left or right hand. The~     other hand will be injected with saline solution. Neither the patient nor the physician or~     research personnel seen in follow-up will know which hand is injected with Botulinum toxin.~   "
178089|NCT01233986|"~     The purpose of this study is to evaluate whether the serum apoB48 level is associated with~     atherosclerotic ischemic stroke.~   "
178090|NCT01233973|"~     To compare the decision making of elderly subjects having a verbal advance care planning~     discussion compared to subjects using a video.~   "
178091|NCT01233960|"~     To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol~     603 to evaluate the safety in subjects with active Crohn's disease who are resistant to~     standard Crohn's disease therapies.~   "
178092|NCT01233947|"~     AFP464 is an investigational agent which may be effective in the treatment of cancer. The~     purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer~     patients.~   "
178093|NCT01233934|"~     Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by~     mast cells in the skin. Topical anti-histaminics can be used to promote relief of these~     symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation~     approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the~     ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority~     of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the~     standard preparation (1% cream) for the relief of insect bite related symptoms and to~     demonstrate the safety of both preparations.~   "
178094|NCT01233921|"~     RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease~     caused by donor stem cell transplant.~      PURPOSE: This randomized clinical trial studies palifermin in preventing chronic~     graft-versus-host disease in patients who have undergone donor stem cell transplant for~     hematologic cancer~   "
178095|NCT01233908|"~     To investigate the prevalence of posttraumatic stress disorder (PTSD) in patients that~     underwent surgery for primary rhegmatogenous retinal detachment (RRD) and to determine~     variables associated with the disorder.~      Design: Consecutive prospective observational study.~   "
178110|NCT01233713|"~     The purpose of this multi-center randomized trial is to identify any differences in the~     complication rates of patients undergoing Hartmann's (end colostomy) versus Primary~     Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the~     stoma reversal operation).~   "
178436|NCT01229410|"~     This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal~     administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery~     System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.~   "
178096|NCT01233895|"~     Primary Objectives:~      Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on~     pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth factor~     1 [IGF-1] serum level) parameters, and eventual dose limiting toxicities (DLTs) in patients~     with recurrent, refractory multiple myeloma (MM).~      Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the~     recommended dose of Velcade®.~      Secondary Objectives :~      Study Part 1:~        -  To assess the safety profile: type, incidence and intensity of drug related adverse~          events (AEs)~        -  To assess the biological activity of AVE1642 (saturation of the receptors and~          down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells~          (PBMC) and granulocytes~        -  To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1~          system (phosphorylated akt [pAkt], phosphorylated erk [pErk]) on malignant plasma cells~          when technically possible~        -  To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3~        -  To assess clinical efficacy (complete response [CR], partial response [PR], minimal~          response [MR] and stabilization) based on the European group for Blood and Marrow~          Transplantation (EBMT) criteria, when possible~        -  To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA)~          anti-AVE1642~      Study Part 2:~        -  To detect any PK or PD interaction between AVE1642 and Velcade®~        -  To assess clinical efficacy (CR, PR, MR, no change [NC]) according to EBMT criteria when~          appropriate~        -  To assess biological activity of AVE1642 in combination with Velcade® on malignant~          plasma cells collected from bone marrow aspirates: saturation and down-regulation of the~          insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization pathway~          of the IGF-1 system (pAkt, pErk) when feasible~        -  To detect immunogenicity reaction (HAHA)~        -  To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be~          non biologically active~   "
178097|NCT01233882|"~     This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with~     renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal~     impairment and subjects with normal renal function will be enrolled. Subjects with mild and~     moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a~     substantial difference in PK profiles between subjects with severe renal impairment and~     subjects with normal renal function.~   "
178098|NCT01233869|"~     This purpose of this study is to determine if bosutinib reduces the rate of kidney~     enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering~     the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or~     equal to 60 mL/min/1.73m2.~   "
178099|NCT01233856|"~     Type of study:~      This study is a prospective, randomized, placebo controlled, double blind trial comparing the~     response to treatment in children with a diagnosis of ADHD treated with stimulants and~     placebo vs. children with a diagnosis of ADHD on stimulants plus Omega-3 fatty acids.~      Hypothesis:~      The use of Lovaza (prescription Omega-3 fatty acids) as an adjunctive therapy for children~     with adequate diagnosis of ADHD on treatment with stimulants will not improve their~     functioning and behavior measured by the Parent and Teacher Conner's Rating Scale and an~     improvement in their Clinical Global Impression.~      Method:~      A total of 30-150 patients between ages of 6 and 15 y/o with diagnosis of ADHD according to~     the DSM-IV-TR and on current treatment with stimulants recruited from CAOS-Maimonides Medical~     Center and the Developmental Center will be evaluated by a child psychiatrist or a resident~     under supervision of a child psychiatrist to make sure that the diagnosis is correct. Every~     child will have a Conners Rating Scale filled out by the parents and teachers on admission to~     the study. The evaluators will also fill out a Clinical Global Impression Scale (CGI).~     Patients will be divided in two groups, one will consist of 15 children taking usual dose of~     stimulants plus placebo and the other group, 15 children will receive the usual dose of~     stimulant plus Lovaza at a dose of 1800mg daily. Both groups will be treated for 8 weeks.~     Patients will be re-evaluated by investigators on week 2,4,6 and 8 of the study and on each~     evaluation the parents and teachers will fill out a Conner's rating scale. Ratings of the~     Conner's scales filled out for each patient will be analyzed and compared to the initial~     evaluation after week 8. Evaluators will also obtain a CGI score for each visit. Patients~     that improve will be taken off the stimulants and will continue further treatment with the~     adjunctive therapy for a total of 4 more weeks, during this period of time, they will be~     re-evaluated on weeks 9,10 and 12 and Conner's Scales will also be filled out by parents.~      Patients who do not improve will be switched to the opposite treatment modality and will be~     evaluated on weeks 9,10 and 12 also having Conner's Scales filled out by their parents. If~     any of the patients in this group improve (after the switch) they will be taken off~     stimulants and they will be evaluated on weeks 13,14 and 16 of the study arm.~      The idea is to conduct the study and obtain information about prescription Omega-3 fatty~     acids as an adjunct to stimulants for patients with ADHD, as several publications have been~     done in the past suggesting it can be beneficial, but there have not been any conclusions on~     whether the treatment is beneficial or not for this population.~   "
178100|NCT01233843|"~     The purpose of this study is to demonstrate that induction chemotherapy followed by radiation~     therapy plus Cetuximab will give better results than the validated treatment~     (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.~   "
178101|NCT01233830|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423~     in young and elderly healthy Japanese volunteers.~   "
178102|NCT01233817|"~     The proposed feasibility study is necessary to test if children and young adults will~     participate in and adhere to a 12-week, home-based, supervised progressive strength training~     exercise program and to obtain preliminary data that will subsequently allow us to determine~     the safety and impact of strength training in spinal muscular atrophy. Our pilot study will~     address 3 aims: (1) Ascertain the feasibility of, and potential barriers to, participation in~     and adherence to a 12-week home-based, supervised, progressive strength training exercise~     program in children and young adults aged 5-21 years with SMA types II and III; (2) Determine~     the safety and tolerability of progressive strength training in a pilot study sample of~     children and young adults with SMA types II and III; and (3) Determine candidate outcome~     measures.~   "
178103|NCT01233804|"~     The purpose of this study is to compare methods for consenting (opting in vs opting out) on~     influenza vaccine uptake rate in pregnant women. This study is designed to learn about the~     impact of influenza vaccination in pregnant women. This study will help gather knowledge~     about influenza vaccine side effects (if given) and whether the vaccine reduces the number of~     respiratory infection in mothers and their infants.~   "
178104|NCT01233791|"~     The purpose of this study is to determine whether vaginal diazepam suppositories are an~     effective treatment of high tone pelvic floor dysfunction.~   "
178105|NCT01233778|"~     The objectives of this study are to examine how the consumption of treatment oils (including~     canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower oil)~     influence endothelial function, inflammation, oxidation, body composition, and plasma~     lipoprotein characterization.~   "
178106|NCT01233765|"~     Recent scientific evidence suggests that the main defence cell of the body (neutrophil)~     behaves in a different manner in patients with gum disease; namely how they interact with~     bacteria and their role in defence systems of the body. This study proposes to examine these~     responses in periodontitis patients and healthy controls.~      The proposed study will include patients undergoing periodontal (gum) treatment who will be~     matched to periodontally healthy controls. Blood, gingival crevicular (gum) fluid and~     clinical measures will be collected both pre- and post-therapy to measure differences in cell~     behaviour both before, and following routine therapy.~      Blood samples will be used to isolate peripheral blood neutrophils prior to analysis of their~     responses to different bacterial stimuli including oxygen radical, cytokine and extracellular~     trap release. Gingival Crevicular Fluid samples will be used to measure different biochemical~     markers that result from the production of Neutrophil Extracellular Traps (NETs). Routine~     clinical measures will be taken both pre- and post-therapy as a measure of treatment~     response.~      Patient volunteers undergoing treatment will be asked to donate a total of four small samples~     of tissue from the gums whilst they are already anaesthetised for routine treatment. These~     will be approximately the size of a needle head (2mm2mm) and used to examine NET formation~     within the tissues and related processes. This will provide novel in-vivo data regarding this~     recently discovered method of neutrophil defence in innate immunity.~      This proposal represents a novel study aimed at improving our current understanding of why~     inflammatory periodontitis develops in some patients but not others, as well as providing~     pointers to causal/noncausal relationships between periodontitis and important systemic~     conditions such as diabetes and rheumatoid arthritis.~      Ultimately, novel treatment approaches and primary prevention (for periodontitis) or~     secondary prevention (for systemic disease) strategies may emerge.~   "
178111|NCT01233700|"~     The purpose of this study is to evaluate the potential effectiveness of a psychosocial~     intervention based on the principles of motivational interviewing. The novel intervention~     will assist living donor candidates to think through any remaining concerns or questions that~     they may have about living donation. If the intervention is effective, it may help to prevent~     post-donation problems related to psychological and health outcomes.~   "
178112|NCT01233687|"~     This is a phase I/II study of erlotinib and AMG 102 in previously treated subjects with~     advanced NSCLC. Subjects will be enrolled with recurrent or progressive advanced stage NSCLC~     that has been treated with at least one and a maximum of two prior chemotherapy regimens. The~     Phase I part of the study will enroll 8-16 subjects with the Phase II part enrolling 21-45~     subjects.~      The Phase I part of the study is designed to determine how safest the combination of AMG 102~     and erlotinib is and the recommended dose for the Phase II part. The Phase II part is to~     determine whether the combination of AMG102 and erlotinib works enough to warrant further~     interest in this combination.~   "
178113|NCT01233674|"~     This study evaluates images obtained from a standard clinical cardiac MRI for evidence of~     fibrosis.~   "
178114|NCT01233661|"~     We intend to examine the effects of temporary elevation of atrial wall stress by shortening~     of the atrioventricular delay in patients with dual-chamber pacemakers.~   "
178115|NCT01233648|"~     This study is being done to find out if controlling rate or controlling rhythm is better for~     heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device~     and AV node ablation as part of their clinical care will be followed for one year. One group~     will have their heart rate controlled by the ICD and AVN ablation alone and the second group~     will be treated with the ICD, AVN ablation and standard medical therapies to restore the~     heart's normal rhythm. The study doctors will compare the information collected from all of~     the subjects in this study to see if treating rate or treating rhythm is better in patients~     with heart failure and AF, resulting in a better quality of life.~   "
178116|NCT01233635|"~     In the present application, we propose to refine and extend current insight into AAF~     mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE~     genotype, and their interaction in secondary AF prevention. We have 3 specific aims:~        1. To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.~        2. To test the hypothesis that the incidence of AF recurrence in the absence of RAAS~          inhibition therapy is higher among patients with the D allele.~        3. To explore the hypothesis that RAAS inhibition therapy is more effective for preventing~          AF recurrence in patients with the DD genotype than in those with DI or II genotypes.~   "
178117|NCT01233622|"~     This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy~     to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).~   "
178118|NCT01233609|"~     The objectives of this study are to evaluate the efficacy of Valproic Acid (VPA) to both slow~     the progression of visual function loss and/or to restore visual function in patients with~     Autosomal Dominant Retinitis Pigmentosa (RP) and to collect safety and tolerability~     information.~   "
178119|NCT01233596|"~     The aim of the study was to compare the success rate of monocanalicular intubation versus~     bicanalicular silicone intubation in congenital nasolacrimal duct obstruction in children~     aged between 10 and 36 months.~   "
178120|NCT01233583|"~     The aim of this study is to understand which therapies will suppress effector cells and~     promote regulatory T cells and To test whether patients with a better response to therapy and~     longer psoriasis-free periods develop a higher numerical ratio of regulatory to effectors~     T-cells and/or regulatory cells more able to suppress the effectors.~   "
178121|NCT01233570|"~     An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns~     disease~   "
178122|NCT01233557|"~     Biomarkers of bone resorption will be measured in the blood of patients with bone metastases~     from prostate cancer during the course of their illness. Changes in these biomarkers will be~     correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the~     response and/or progression of their cancer. It is hoped that serial measurement of these~     biomarkers may allow therapeutic monitoring in the future with successful individualisation~     of bisphosphonate therapy for metastatic prostate cancer.~   "
178123|NCT01233544|"~     This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation~     (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma~     liver metastases.~      Primary end point is local progression free survival.~   "
178124|NCT01233531|"~     Cash transfers to young women for staying in school and its effect on acquiring HIV~   "
178125|NCT01233518|"~     This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and~     Asian centers designed to determine the diagnostic performance of CT-FLOW (the~     investigational technology) by coronary computed tomographic angiography (CCTA) for~     non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to~     direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a~     reference standard.~   "
178126|NCT01233505|"~     This phase I trial is studying the side effects and the best dose of veliparib when given~     together with capecitabine and oxaliplatin in treating patients with advanced solid tumors.~     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving veliparib together with capecitabine and oxaliplatin may kill more tumor~     cells.~   "
178127|NCT01233492|"~     RATIONALE: Giving boron phenylalanine in different ways and measuring it in tissue in~     patients with glioblastoma multiforme may help in planning better radiation therapy, such as~     boron neutron capture therapy, for patients in the future.~      PURPOSE: This phase I trial is studying the side effects, best dose boron phenylalanine, and~     best way of giving it with or without mannitol in treating patients with glioblastoma~     multiforme.~   "
178128|NCT01233479|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving radiation~     therapy and chemotherapy may help doctors learn more about the effects of this treatment on~     cells. It may also help doctors understand how well patients respond to treatment.~      PURPOSE: This research study is studying biomarkers in blood samples from young patients with~     newly diagnosed brain tumors undergoing standard radiation therapy and chemotherapy.~   "
178129|NCT01233453|"~     This is a prospective, randomized, multi center study. Approximately 2700 patients will be~     entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility~     criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS®~     stent versus the Biolimus A9 eluting NOBORI® stent. Patients will be followed for 5 years.~   "
178130|NCT01233440|"~     The primary objective of the study is to assess the safety of IV administration of rIX-FP.~     Safety will be evaluated by adverse events and laboratory changes over time. The secondary~     objective of the study is to evaluate the pharmacokinetics parameters, following a single~     intravenous dose of rIX-FP.~   "
178131|NCT01233427|"~     Characterize a population-based sample of first-time expectant mothers with regards to~     maternal metabolic health and their infant feeding experience.~   "
178132|NCT01233414|"~     The purpose of this 24 week study is to determine whether a new Parent Training program is~     effective in reducing disruptive behaviors in young children with pervasive developmental~     disorders.~   "
178133|NCT01233401|"~     This study evaluates whether offering Tetanus, diphteria and acellular pertussis (Tdap)~     vaccine to caregivers of newborn infants during pediatric well child visits increase the~     caregivers' vaccination rates.~   "
178134|NCT01233388|"~     The aim of this proposal is to pioneer the implementation and evaluation of a novel patient~     centered text messaging vaccine adverse event surveillance network.~   "
178135|NCT01233375|"~     The purpose of this study is to determine whether CO-1.01 is safe and effective for treating~     metastatic pancreatic cancer that did not respond to gemcitabine.~   "
178136|NCT01233362|"~     The absence of a boosting response after a 14 day interval with the two-dose regimen of the~     modified killed oral cholera vaccine raises the possibility that a longer dosing interval may~     be required to observe a boost in the immune response. This study will compare the immune~     responses following 14-day and 28-day dosing intervals.~   "
178137|NCT01233349|"~     Preparations that bind to nutritional fat and inhibit its absorption could be decisively~     meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble~     fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after~     eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The~     medical device to be investigated contains a patented formula of fibre complex having a high~     ability to bind to dietary fat.~      Therefore, the rationale for this study is to confirm that Litramineʼs proven fat binding~     capacity to increase fat excretion and modulate the feeling of satiety will translate into~     measurable reduction in body weight. A double blind, randomized, placebocontrolled design has~     been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects~     on a energy-restricted diet.~   "
178138|NCT01233336|"~     This is the continuation of previous study (registration number: NCT00844987) which revealed~     that hepatocyte growth factor (HGF) is a very early, good marker of myocardial injury and~     prognostic factor for post myocardial infarction (MI) cardiovascular events presence in~     long-term follow-up. Due to potentially very important implication of the results of previous~     study it was decided to continue research of HGF in patients with MI. Now, is scheduled to~     examine 100 consecutive patients with STEMI. HGF assessments will be performed just after~     admission to hospital, 1h and 24h later and before discharge. Two follow-up visits were~     planned i.e. at 3 and 6 months after MI. During hospitalization and at 6 month visit the~     echocardiography examination will be performed. The composite primary endpoint consists of~     cardiovascular events observed during hospital course and in long term-follow-up.~   "
178139|NCT01233323|"~     The purpose of this study is to collect sensor data from patients with implanted cardiac~     resynchronization devices who exhibit phrenic nerve stimulation.~   "
178140|NCT01233310|"~     Study Hypothesis:~      It is estimated that by re-programming some of the PillCam COLON2 system parameters it can~     serve as tool for visualizing both small bowel and colon. As such, the system may be utilized~     in CD patients for monitoring mucosal healing.~      Primary objectives:~      To evaluate two different video output methods in the visualization of the SB and colon in CD~     patients~      Secondary objectives:~        -  Evaluate the level of agreement between PillCam system and ileocolonoscopy on the~          assessment of CD findings.~        -  Evaluate the effectiveness of PillCam regimen in CD patients~      Inclusion criteria~        -  Patient is 18 years of age and above~        -  Patient with a diagnosis of ileocolonic or colonic Crohn's Disease documented by~          endoscopical, histopathological and/or radiological parameters~        -  Patients' CDAI >150.~        -  Patient is clinically indicated to undergo ileocolonoscopy for assessment of Crohn's~          disease~        -  Proven patency by Agile capsule or another approach deemed clinically acceptable by the~          investigator, e.g. CT enterography, performed within the 3 months prior to enrollment~        -  Patient is able and agrees to sign the Informed Consent Form~      Exclusion criteria~        -  Patient has dysphagia~        -  Patient has congestive heart failure~        -  Patient has renal insufficiency~        -  Patient has cirrhosis~        -  Patient is known or is suspected to suffer from intestinal obstruction~        -  Patient has known previous stricture/obstruction of the SB or colon~        -  Patient has taken NSAID medications less than one month before enrollment~        -  Patient suffers from hypertension and is taking one or more of the following medications~          used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers~        -  Chronic use of laxatives~        -  Patient has a cardiac pacemakers or other implanted electro medical devices.~        -  Women who are either pregnant or nursing at the time of screening, who intend to be~          during the study period, or are of child-bearing potential and do not practice medically~          acceptable methods of contraception.~        -  Patient is expected to undergo MRI examination within 7 days after ingestion of the~          capsule.~        -  Patient has had prior abdominal surgery of the gastrointestinal tract other than~          uncomplicated procedures that would be unlikely to lead to bowel obstruction based on~          the clinical judgment of the investigator.~        -  Patient has any condition, which precludes compliance with study and/or device~          instructions.~        -  Patient suffers from life threatening conditions~        -  Patient is currently participating in another clinical study~        -  Patient has known slow gastric emptying time~        -  Patient is allergic or contraindicated to any of the study medications~   "
178141|NCT01233297|"~     Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to~     viral infection. The current study will examine whether treatment of asthmatic exacerbations~     with macrolide antibiotics - in the abscence of clear clinical bacterial infection which~     would in any case precipitate antibiotic treatment - has an effect on either the particular~     episode, or subsequently. Macrolide antibiotics are chosen for ease of administration~     ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.~   "
178153|NCT01233141|"~     The rationale of this study is to establish a registry to detect and follow patients with CLI~     treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence,~     and actual outcome of CLI patients in a real world setting and should serve as a tool for the~     evaluation of medical, endovascular and surgical interventions. It will help determining the~     prognosis of individual patients and have impact on economic and political decisions in~     Vienna concerning this disease and the related costs.~   "
178154|NCT01233128|"~     This study is to investigate whether there is an association of the LOC387715/HTRA1 and~     vascular endothelial growth factor polymorphism with response to treatment with intravitreal~     ranibizumab injections for patients with polypoidal choroidal vasculopathy.~   "
178142|NCT01233284|"~     Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25~     µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with~     moderate persistent asthma who are still symptomatic despite regular maintenance therapy with~     inhaled corticosteroids (ICS).~      The data collected in the present trial will provide useful information to health care~     providers and patients regarding the efficacy and safety of a once daily inhalation of three~     different doses of tiotropium solution delivered by the Respimat® inhaler in addition to~     inhaled corticosteroids in the treatment of not fully controlled moderate asthma in~     comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD~     patients. However, there is currently no PK data available for the 3 doses of tiotropium~     being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once~     daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours~     in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients.~     Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a~     once daily dosing of tiotropium inhalation solution is effective and safe in the treatment of~     moderate persistent asthma.~   "
178143|NCT01233271|"~     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.~     Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of~     the intensive care unit staff difficulties were experienced in achieving efficient and safe~     glucose control. A fully automated algorithm may help to overcome some of these limitations~     by excluding intuitive interventions and integrating relevant clinical data in the~     decision-making process. Space GlucoseControl (TGC system) is a decision support system which~     helps to achieve safe and reliable blood glucose control in the desired ranges. Information~     on parenteral and enteral nutrition is automatically integrated into the calculations. The~     primary objective of the current study is to investigate the performance and usability of the~     Space TGC system for glucose control over an extended glucose control range (4.4 to 8.3~     mmol/L) in postoperative cardiac surgery patients.~   "
178144|NCT01233258|"~     The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with~     BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe~     Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand~     treatment.~   "
178145|NCT01233245|"~     This is an observational survey to assess the factors that influence adherence to Betaferon~     therapy in multiple sclerosis patients using elements of the BetaPlus support program,~     including the nurse support and auto-injectors. The patients were evaluated under normal~     clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping~     processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.~   "
178146|NCT01233232|"~     The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients~     with Chronic Obstructive Pulmonary Disease~   "
178147|NCT01233219|"~     Identification of the genetic polymorphisms that could be correlated either with a better~     clinical response or with a major predisposition of patients to develop tolerance and/or side~     effects to the treatment with morphine.~   "
178148|NCT01233206|"~     The use of metformin pre-treatment and co-administration was recently proposed in infertile~     women affected by polycystic ovary syndrome (PCOS) treated with gonadotropins.~      Data from meta-analyses showed that metformin administration significantly reduced the~     stimulation length and the total dose of gonadotropins used in PCOS women undergoing~     gonadotropins stimulation for non in-vitro fertilization (IVF) cycles. On the other hand, in~     IVF cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation~     syndrome (OHSS) rate in infertile patients with PCOS treated with gonadotropins.~      The metformin regulating effect on the ovarian response was also observed in a randomized~     controlled trial (RCT) on young non-obese insulin-resistant women with PCOS receiving~     gonadotropins for mono-ovulation induction. In particular, metformin increased the~     mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used,~     while it reduced the number of dominant follicles and the estradiol (E2) levels.~      The aim of the present study was to evaluate the effect of metformin administration in high~     responder PCOS patients undergoing gonadotropins ovarian stimulation for IVF cycles.~   "
178149|NCT01233193|"~     The purpose of the study is to test if a Pharmacist Intervention Program with home blood~     pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure~     levels in hypertensive patients under pharmacological treatment, compared to those who~     receive usual care in a community pharmacy setting.~   "
178150|NCT01233180|"~     Gua Sha massage is a traditional chinese medical treatment. It is mostly used in the~     treatment of the common cold and pain syndromes. Gua Sha involves pressuring the skin by a~     round-edged instrument until small petechiae appear. This so called sha, considered as the~     removal of blood stasis by traditional practitioners, will fade within a few days. Normally,~     this treatment is not considered as painful, but as relaxing and easing tense muscles.~      In this study, the investigators will investigate the effectivity of Gua Sha massage in~     treating chronic neck pain. The investigators will research effects on subjective pain~     intensity, neck pain specific disability and haptic perception.~   "
178151|NCT01233167|"~     The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone versus~     steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our subject~     is beyond a 12-month period patients receiving sirolimus drug-eluting stent implantation.~   "
178152|NCT01233154|"~     Various studies in animal and humans have shown a potential beneficial effect of probiotics~     consumption on allergy. However few studies exist that document their efficacy for upper~     airways allergies such as allergic rhinitis. The objective of this study is to investigate~     the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics~     (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed~     out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a~     randomized, double-blind study, based on two 4-weeks cross-over periods of product~     consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical~     parameters of NPT as well as systemic and nasal immunological markers are compared before and~     after each treatment.~   "
178155|NCT01233115|"~     This study is to investigate whether there is an association of the LOC387715/HTRA1 variants~     with response to treatment with combined photodynamic therapy and intravitreal bevacizumab~     for patients with polypoidal choroidal vasculopathy.~   "
178156|NCT01233102|"~     The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem~     cells (MSCs) transfusion in the treatment of liver cirrhosis. Liver function will be~     monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total~     bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at~     pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for~     End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.~   "
178157|NCT01233089|"~     The purpose of this three-month study is to compare the quality of life and ease of fit among~     children wearing investigational single-vision contact lenses, commercially marketed~     single-vision contact lenses, and commercially marketed multifocal contact lenses.~   "
178158|NCT01233076|"~     The purpose of this study is to evaluate the performance of two commercially marketed daily~     disposable contact lenses in a population of daily disposable contact lens wearers.~   "
178159|NCT01233063|"~     The trial will test whether the Alive email-delivered health behavior program can improve~     subjects' physical activity, fruits and vegetables and saturated/trans fats and added sugars.~   "
178160|NCT01233050|"~     Surgical site infections (SSI) are one of the most common complications in the post-operative~     patient, and the second most common health care associated infection overall. It is estimated~     that there are between 500 thousand and 1.1 million surgical site infections in the United~     States each year. Given the magnitude of the problem, prevention of surgical site infections~     is a major goal of peri-operative care. However, skin preparation prior to surgery has not~     been as rigorously examined. The primary objective of this study is to compare the efficacy~     of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate /~     70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in~     the prevention of superficial surgical site infection. Male and female patients, age 18 years~     and older undergoing elective colorectal surgical procedures involving a laparotomy will be~     enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at~     regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI.~     Patients will remain enrolled into the study until 35 days postoperatively.~   "
178161|NCT01233037|"~     This is a non-randomized feasibility study of endothelial function, exercise capacity, and~     outcome following pre-left ventricular assist device (LVAD)therapy and cardiac transplant.~      The study period will be 5 years, with 20 patients to be enrolled. The investigators~     anticipate that 15 patients will survive to complete the one year follow up period.(the~     published survival rate of LVAD is 75% in one year). 10 patients are anticipated to undergo~     cardiac transplant within 3 years of initial enrollment and they are followed until their 2nd~     annual post transplant invasive evaluation.~      Markers of endothelial function will be studied to permit comparison with selected clinical~     outcomes. The hypothesis is that the endothelial functions will be altered after implantation~     of LVAD then before its implantation, both acutely and chronically, and this may affect the~     exercise capacity, quality of life and occurrence of cardiac allograft vasculopathy post~     cardiac transplantation.~   "
178162|NCT01233024|"~     Studies have found a relationship between dietary fiber consumption and body weight~     regulation. This relationship may stem from enhanced satiety through fermentation of certain~     fibers in the large intestine.~      The objective of this study is to determine and compare satiety ratings, changes in food~     intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble~     corn fiber, and resistant starch.~   "
178163|NCT01233011|"~     The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically~     engineered for use both as a standalone laryngeal mask airway (LMA) and as a rescue device or~     Plan B device in the event of a difficult airway. As with some other types of LMA, it is~     then possible to insert an endotracheal tube (ETT) through the Air-Q® ILA, either blindly or~     mounted on a fibreoptic bronchoscope (FOB), to achieve endotracheal intubation. This will be~     a prospective observational study of the Air-Q® ILA's performance.~   "
178164|NCT01232998|"~     The investigators want to survey Emergency Department Patient Satisfaction in the Imam Reza~     hospital ,Tabriz ,Iran by questionnaire form . Finally the investigators want to improve the~     quality services in the department based on the research result.~   "
178165|NCT01232985|"~     The purpose of this study is to find out if investigational device, RD047-26, is safe and~     useful for the treatment of mild to moderate atopic dermatitis.~   "
178166|NCT01232972|"~     The purpose of this investigation is to offer the opportunity for young women to cryopreserve~     (freeze) their oocytes (eggs) for use with IVF at a later point in time.~   "
178167|NCT01232959|"~     Today there are three different ways to remove a gallbladder with gallstones. Surgeons can~     remove the gallbladder through small incisions in the abdomen. This is called laparoscopic~     cholecystectomy. It is the current standard. It has replaced traditional open gallbladder~     surgery. Open gallbladder surgery is done with a large incision. A new way of removing the~     gallbladder in women is through the vagina. This is called transvaginal cholecystectomy. This~     study is being done to see if removing the gallbladder through the vagina will work for~     patients at Mayo Clinic Rochester. This is the first step of this research to test the~     procedure. In the future, other studies will examine the potential for less scarring and~     reduced pain. In this study the investigators will still make small incisions in the abdomen,~     they will be smaller than the standard procedure but you will still have some scars on your~     abdomen.~      Some very early research reports say that some patients may have less pain with the~     transvaginal approach; however, the investigators do not know if the transvaginal route will~     have any effect on your overall health and quality of life.~      This study will evaluate:~        -  Effectiveness of the surgery: ability to remove the gallbladder safely~        -  Effect of the operation on your body: change in pulse and blood pressure during the~          surgery, level of inflammation markers in your blood before and after the surgery~        -  Recovery from surgery in the hospital: how much pain you have, how much pain medication~          you need, how long you need to stay in the hospital, or nature of any surgical~          complications (problems)~        -  Overall recovery from surgery: general quality of life, abdominal symptoms~      What is the new type of surgery?~      The new type of surgery is called transvaginal cholecystectomy:~      A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is~     inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A~     very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps~     the surgeons to remove your gallbladder through the vagina. The procedure to separate your~     gallbladder from your body will be assisted by instruments placed through your abdomen and~     instruments placed in your vagina. The surgeon will remove the gallbladder by passing it~     though your vagina.~   "
178168|NCT01232946|"~     27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone~     or with oral antidiabetic agents will be randomly assigned to one of three treatment groups:~     insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a~     background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of~     myocardial fuel selection will take place, under fasting conditions in the morning following~     that day's treatment injection(s).~   "
178169|NCT01232933|"~     Subjects meeting study requirements will be consented and have their PICC catheter placed~     using navigational technology and the tip placement confirmed with radiographic imaging.~   "
178170|NCT01232920|"~     The proposed study is a masked trial, with stratified block randomization by site, designed~     to determine which treatment, methotrexate or mycophenolate mofetil, is more effective as~     first-line steroid-sparing treatment for patients with non-infectious uveitis requiring~     corticosteroid-sparing therapy.~      One hundred non-infectious uveitis patients in need of corticosteroid-sparing therapy will be~     randomized to receive either oral methotrexate or oral mycophenolate mofetil at Aravind Eye~     Hospitals (Madurai and Coimbatore, South India). They will be followed monthly for 6 months~     after enrollment or until treatment failure. The investigators hypothesize that the~     proportion achieving corticosteroid-sparing success at 6 months for patients taking~     mycophenolate mofetil will be improved in comparison with patients taking methotrexate.~   "
178171|NCT01232907|"~     1. Purpose: To explore the use of L-Carnitine, a pharmaceutical product, for the treatment~          of fatigue in persons with spinal cord injury (SCI).~        2. Hypothesis: Similar to previous research in disabled and aging populations, the~          investigators hypothesize that treatment with L-Carnitine will result in a significant~          improvement of clinical fatigue in spinal cord injury clients, effecting a decrease on~          the Fatigue Severity Scale (FSS) of 0.5 points or more. The investigators expect to see~          an effect after approximately three weeks of treatment.~      As secondary outcomes, the investigators expect to see positive changes in the Centre for~     Epidemiologic Studies Depression Scale (CES-D)and Visual Analogue Fatigue (VAS-F) and Visual~     Analogue Pain (VAS-P) scores, due to a combination of previously demonstrated effects of~     L-Carnitine directly on pain and depression, and the effects of the potential decrease in~     fatigue.~   "
178172|NCT01232894|"~     In this 12-week study, patients were randomized to either open-label indacaterol or standard~     of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were~     assessed.~   "
178173|NCT01232881|"~     This is a tumor and serum collection study for patients with advanced breast cancer receiving~     treatment with lonafarnib.~   "
178174|NCT01232868|"~     Vaccination is the most effective way of preventing infectious diseases. Despite the success~     of vaccines in general, vaccines induce diminished antibody responses and lower protection in~     the elderly in particular. This could be explained by a defect in the early responses of an~     ageing immune system. A better understanding of the basic immunological mechanisms that~     mediate vaccine efficacy is incomplete. Such information is critical and could greatly~     decrease both the cost and the time to new vaccine development particularly for the geriatric~     population.~      In this trial, the investigators will study the immunologic differences of an FDA approved~     licensed influenza vaccine between a younger and an older group. Twenty two healthy~     volunteers between the age of 25-40 and forty four healthy volunteers above the age of 65~     will be enrolled in the study. Each participant in the study will be given one flu shot.~     Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen~     days, as well as one month and six months after vaccination. Throughout the duration of the~     study, the participants will be monitored for safety.~   "
178175|NCT01232855|"~     RATIONALE: Studying samples fo tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     acute promyelocytic leukemia.~   "
178176|NCT01232842|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     acute myeloid leukemia.~   "
178177|NCT01232829|"~     This phase II trial is studying how well RO4929097 (gamma-secretase/Notch signalling pathway~     inhibitor RO4929097) works in treating patients with previously treated metastatic pancreatic~     cancer. RO4929097 may stop the growth of tumor cells by blocking some enzymes needed for cell~     growth.~   "
178178|NCT01232816|"~     Delayed graft function (DGF) increases risk of acute rejection after kidney transplantation~     (KTx). Interleukin-6, which is produced in DGF, is critical in directing naive T helper cells~     differentiation towards T helper 17 (Th17) and away from regulatory T (Treg) cells. The~     investigators hypothesize there is an increase in Th17 and a decrease in Treg expression in~     KTx recipients with DGF compared to those without, leading to immunologic consequences. The~     investigators will test their hypothesis by measuring in both groups expression of Th17,~     Treg, and related cytokines in blood, urine, kidney biopsy, and kidney preservation fluid,~     and correlating these results with immunologic events.~   "
178179|NCT01232803|"~     MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study~     of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied~     rectally. The primary objective of this study is to assess the safety of vaginally formulated~     tenofovir 1% gel when applied rectally.~      After completing screening and baseline evaluation, eligible participants will be randomized~     to receive tenofovir 1% gel, 2% nonoxynol-9 gel (N-9) or placebo gel. The study will also~     include a no treatment arm. There will be 15 participants in each arm.~      Participants will return to the clinic, where they will self-administer a single dose of the~     study gel under observation. Within approximately 30 minutes, lavage, stool, and rectal~     biopsy specimens will be obtained. After a one-week recovery period, participants will return~     to the clinic for assessment. If no significant adverse events (AEs) are reported they will~     begin to self-administer once-daily outpatient doses of the study gel for 7 days.~     Participants will return to clinic for evaluation and specimen collection after completion of~     7 days of daily dosing.~   "
178180|NCT01232790|"~     The purpose of this study is to evaluate the effects of the amino acid supplement~     N-Acetylcysteine versus placebo on working memory and other cognitive functions in persons~     with a diagnosis of schizophrenia.~   "
178181|NCT01232777|"~     The purpose of this study is to determine whether a single intravitreal (into the gel of the~     eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with~     standard of care laser in infants with Type I pre-threshold retinopathy of prematurity (ROP)~     diagnosed at 30-36 weeks gestational age.~   "
178223|NCT01232231|"~     The purpose of this study is to determine the effectiveness of topical and oral antibiotics~     in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those~     living in the community. We hypothesize that a greater proportion of those who receive~     intervention will eliminate MRSA carriage compared to those who do not receive any~     intervention.~   "
178182|NCT01232764|"~     The purpose of this study is to evaluate the effectiveness of 'enhanced' multi-disciplinary~     wound care teams (MDTs) vs. 'usual' care teams in Long Term Care (LTC) facilities in Ontario~     for the treatment of pressure ulcers. LTC facilities with more than 100 beds that are within~     a 100 km distance from St. Mikes and have a problem with pressure ulcers will be asked to~     participate. A total of 10 LTC facilities will be randomly selected (i.e. selected by chance)~     from those that agree to participate.~      The 'enhanced' MDT will be an Advance Practice Nurse(APN) with expertise in wound care who~     has direct access to the wound care team at St. Mikes. This APN will develop treatment plans~     in consultation with facility staff, providing targeted pressure ulcer treatment education on~     an ongoing, case by case basis. Care is supported by telemedicine with the use of digital~     photography and online communication between members of the care team.~      This study is a stepped wedge randomized trial, meaning LTC facilities are assigned to a~     start date for this study totally by chance. Changes in healing rates, wound related pain,~     cost, number of new pressure ulcers, and number of wounds healed will be measured before, and~     after the APN is introduced to facilities. In order to gain more insight into how people felt~     about this model of care, interviews will be held with individuals and groups of staff at 5~     randomly selected facilities before, during, and after the study has been completed.~   "
178183|NCT01232751|"~     Alleged benefits experienced by the consumption of soy in Asian countries have been~     attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are~     believed to relieve menopausal symptoms and are therefore often consumed in supplement form~     in Western countries. These supplements contain relatively high amounts of isoflavones, and~     the question is if these concentrations still exert beneficial effects or whether negative~     effects become dominant. Therefore, the investigators will study the effect of intake of one~     dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral~     Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.~   "
178184|NCT01232738|"~     ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons~     in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and~     loss of muscle function. While there are drugs to help relieve symptoms of ALS, there is no~     cure for ALS.~      Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means~     that the nervous system may be protected against weakening. It is known that rasagiline has~     possible neuroprotective characteristics and it is approved for use for patients with another~     disorder, the effectiveness of rasagiline for patients with ALS has not been tested.~   "
178185|NCT01232725|"~     Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all~     infants, optimizes intellect, and provides protection against infectious and atopic diseases~     in childhood as well as decreasing risks for obesity, hypertension and other chronic~     diseases. Infants with the highest risk of life-long disability, very low birthweight (VLBW)~     preterm infants, are breastfed at some of the lowest rates in the US. Maternal milk is not~     always available, and pasteurized donor human milk is an alternative that requires~     investigation. Whether donor milk conveys health and developmental advantages similar to~     those bestowed by maternal milk is unknown. By determining the effects of donor milk on~     health and developmental outcomes when compared to preterm infant formula, the investigators~     seek to optimize outcomes in this fragile population. The hypothesis of our donor milk~     research is that a donor human milk diet in non-maternal milk fed VLBW infants is associated~     with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm~     infant formula diet.~   "
178186|NCT01232712|"~     The scientific approach behind this study is to develop novel anti-cancer therapeutic vaccine~     to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes~     populations and can be be applicable to the majority of the target population.~   "
178187|NCT01232699|"~     Internet-based weight control programs have been shown effective in producing weight loss,~     but in-person delivery of behavioral weight control produces significantly greater weight~     loss than on-line delivery of the same program. Motivational Interviewing has been shown to~     increase weight loss when delivered as an adjunct to in-person weight loss programs but has~     not been examined in conjunction with web-based obesity treatment. Therefore, the overall~     goal of this project is to determine if the addition of on-line Motivational Interviewing to~     a web-based group behavioral obesity treatment program will augment weight loss outcomes.~   "
178188|NCT01232686|"~     The study investigates whether shared online access to epidemiological data for general~     practitioners, disease prevention officers, emergency care services and microbiology~     laboratories changes clinical practice with regard to testing, diagnosing and treatment of~     communicable diseases. The main hypothesis is that online access for general practitioner to~     epidemiological data about communicable diseases changes clinical practice for testing,~     diagnosing and treatment of communicable diseases.~   "
178189|NCT01232673|"~     A total of 90 patients suffering from end stage-IV Fontaine /CLI and diabetic foot with an~     ulcerated limb in whom all previous therapeutic strategies failed (e.g. surgical~     revascularization) will be selected and undergo local transplantation of ABMSCs. The~     efficacy/safety of this therapy will be assessed by using several endpoints such as (a)~     prevention of amputation, (b) wound healing and (c) degree of angiogenesis. In order to~     assess the limb ischemia and hypoxia the several tests and measurements will be performed~     pre- and post transplantation at a variety of time intervals. The measurements include:~     TP-toe pressure measurements (by Periflux 5000 Laser Doppler and Oxymetry system), SPP-skin~     perfusion pressure, ABI-ankle brachial index, LDP-laser Doppler baseline and heat perfusion~     assessment, TcpO2 without and with O2 provocation inhalation test. In addition, a battery of~     biochemical and hematological tests of peripheral venous blood sample will be performed.The~     quality form EQ-50 will be completed.~      8.1 Primary objective: To evaluate an efficacy-safety profile of autologous bone marrow stem~     cells (ABMSCs) transplantated into chronically and critically ischemic limb (CLI) and into~     diabetic foot in stage IV Fontaine, Rutherfod 4-6 classification.~      8.2 Secondary objectives: 8.2.1 To assess effect of ABMSCs on tissue perfusion of ischemic~     limb after transplantation by transcutaneous oximetry and the laser Doppler flowmetry using~     Periflux 5000 system under normal and provocation test conditions. In addition, wound healing~     of ulcers will be evaluated using a planimetry method from photographs of affected skin taken~     pre- and post-transplantation.~      8.2.2 Relationship between CD 34 progenitor counts separated on gradient-density separation~     centrifuge from Harvest Technologies and overall effectiveness and safety to treat ischemic~     limb.~      8.3 Priorities: Beside assessment of effectiveness and safety of ABMSCs transplantation~     ultimate emphasis will be put on avoiding limb amputation. This has significant socioeconomic~     impact. Therefore this project belongs to the priority programs of clinical research in~     cardiovascular diseases.~   "
178224|NCT01232218|"~     The purpose of this study is to determine if a specific stretching and strengthening~     protocol, in addition to current standard treatment, is more effective for treating~     post-stroke shoulder pain than current standard treatment alone.~   "
178190|NCT01232660|"~     The purpose of the study is to examine the effects of adding a drug called~     hydroxychloroquine, usually used to treat rheumatoid arthritis, to patients' usual~     antiretroviral combination. HIV causes activation of some parts of the immune system and this~     immune activation may persist despite effective antiretroviral therapy. Ongoing activation~     may be responsible for poor CD4 rise on antiretroviral therapy and for some HIV-related~     complications. Drugs like hydroxychloroquine work by inhibiting immune activation.~      The study will primarily investigate the effect of adding this medication on immunological~     parameters (particularly CD4 count), on other safety parameters (such as cholesterol),~     patients' side effects and viral load.~      If you decide to take part, the duration of your involvement in the study will be 24 weeks~     plus two screening visits up to 84 days prior to the start of the study and a follow up~     visit.~   "
178191|NCT01232647|"~     Vitamin K is thought to be important for bone health because it activates several proteins~     involved in bone formation. Poor dietary intake of vitamin K (mainly found in dark green~     leafy vegetables) is associated with bone loss and fractures. Giving supplements of the main~     dietary form of vitamin K (called K1) or another common form which our bodies make from~     K1(called MK4), to improve bone health have given mixed results. This confusion is thought to~     have arisen because these studies involved people who already had enough vitamin K or did not~     have osteoporosis. We want to test the hypothesis that treatment with bisphosphonates~     combined with vitamin K, in vitamin K deplete elderly women with osteoporosis, may offer~     additional benefit on skeletal metabolism and reduction of fracture risk. We want to test~     this by measuring vitamin K status in post-menopausal women with osteoporosis who are on the~     recommended treatment with a bisphosphonate and calcium/vitamin D supplements. Those with low~     vitamin K will then be recruited to study the effect of supplementation with either K1 or~     MK4.~   "
178192|NCT01232634|"~     The purpose of this study is to test the external validity of the systemic ultrasound~     protocol for data acquisition and interpretation, in order to diagnose soft tissue and~     osteochondral abnormalities in hemophilic children.~   "
178193|NCT01232621|"~     In the Approach Study, the investigators will study the 'process' by which Substitute~     Decision Makers (SDMs) are approached for consent for their loved one's participation in~     critical care research. The investigators will randomize SDMs of critically ill patients who~     are eligible to participate in any research study in operation to either 'physician~     introduction' of the research team or 'non-physician approach (non-physician)' in which~     research coordinators are introduced by allied health care team members or introduce~     themselves directly to SDMs. This study seeks to identify important features of the 'consent~     to research' process that can be modified to enhance both SDM satisfaction with the consent~     process and recruitment into critical care research studies.~   "
178194|NCT01232608|"~     Diabetes mellitus (DM) is an important risk factor in the development of cardiovascular~     disease, and people with type 2 diabetes have a two- to four-fold increased risk for~     cardiovascular morbidity and mortality. Physical activity is a well established therapeutic~     modality for type 2 diabetes. In patients with coronary artery disease (CAD), several~     clinical trials have shown reduced mortality and reduced progression of atherosclerosis with~     lifestyle intervention including physical activity. But few studies have investigated the~     effect of physical training in patients suffering from both diseases.~      The aim of this study is to investigate the effect of one year of organized physical exercise~     in patients with both coronary heart disease and type 2 diabetes on glucometabolic state and~     progression of atherosclerosis.~      The project is a randomized, controlled, open study on physical exercise. 136 patients will~     be randomized at inclusion to a physical exercise group or a control group, the latter with~     normal follow-up and not discouraged form physical activity. The intervention period will~     be 12 months, and the physical training program will be developed and conducted in~     collaboration with Norwegian School of Sport Sciences. The inclusion of patients started~     summer 2010, the exercise program begins in September 2010 and the practical issues of the~     study is planned to end during spring 2012.~      The main hypothesis is that physical exercise improves the glucometabolic state and reduces~     progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes,~     and secondary that physical exercise induces favourable changes in cardiovascular risk~     factors, use of medication, and co-morbidity associated with diabetes.~   "
178195|NCT01232595|"~     This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in~     patients who have moderate Clostridium difficile infections.~   "
178196|NCT01232582|"~     Chronic pain affects an estimated 50 to 65 million individuals in the US, and its incidence~     and prevalence is steadily on the rise in correspondence with the increasing longevity of the~     population. Spinal pain, encompassing lower back, thoracic and neck pain, is a very common~     type of chronic pain that can greatly reduce quality of life. Facet joint pain is most often~     associated with facet arthropathy or degenerative arthritis of the joint. This condition~     develops due to progressive wear and tear caused by the small but repetitive strain of the~     joints throughout a lifetime. Strain and inflammation can induce fluid distention of the~     joints which in turn can result in compression of the nerve roots of the joint - the origin~     of the chronic pain.~      Current treatments for facet arthropathy and pain include oral medications, intra-articular~     injections of anesthetic or steroid medications, energy ablation (e.g. radiofrequency~     ablation) for denervation, and in some severe cases facet rhizotomy (surgical severing of the~     nerves).~      The ExAblate magnetic resonance guided focused ultrasound system enables noninvasive focal~     ablation of tissue. Results from feasibility studies, including those from the FDA approved~     feasibility study (IDE # G050177) have shown the palliative effect of the ExAblate for~     patients with bone metastases. It is reasonable to assume that this palliative effect of~     MRgFUS could also translate to the alleviation of facet pain if focused ultrasound beams are~     directed to the facet joints. The highly-target focal ablation could also diminish the risk~     of complications that are often associated with other less selective denervation techniques.~      The objective of this trial is to evaluate the safety and effectiveness of the ExAblate~     system and the treatment of pain resulting from facet joint osteoarthritis.~   "
178225|NCT01232205|"~     The purpose of this study is to investigate the benefit of several micro nutrients of~     antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in~     cell-free mRNA.~   "
178226|NCT01232192|"~     The purpose of this study is to determine whether antenatal model in vaginosis are effective~     in preventing vaginal infection and preterm delivery~   "
178197|NCT01232569|"~     This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the~     reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in~     combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with~     active, moderate to severe rheumatoid arthritis. In the double-blind part of the study,~     patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously~     every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study,~     patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from~     Week 24 to Week 96 using a pre-filled syringe or an auto-injector.~   "
178198|NCT01232556|"~     The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab~     in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for~     intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of~     this combination compared with an active comparator arm (investigator's choice of~     rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall~     survival.~   "
178199|NCT01232543|"~     The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are~     administered Product 0405 for the treatment of Atopic Dermatitis~   "
178200|NCT01232530|"~     This is a phase IV open label study assessing the safety and effectiveness of artemisinin~     derivatives-based combination therapy (ACT) when used on a large scale and under real life~     conditions.~   "
178201|NCT01232517|"~     The purpose of this research study is to gather information about the NeuroVision System~     (which is FDA cleared for this indication) during the placement of pedicle screws.~     NeuroVision is a machine that monitors nerve activity during surgery and will alert the~     surgeon if there are any nerve-related issues during screw placement. The use of nerve~     monitoring is standard of care at most centers during spine surgery. The standard monitoring~     for screws placed is performed after the screw is placed, to ensure it is well positioned in~     the bone (if it is not, the screw may be removed and/or repositioned). The NeuroVision System~     has a novel feature called Dynamic Screw Test that allows for that monitoring to be~     performed as the screw is placed, rather than after the fact. This study is being done to~     determine if this real-time monitoring of screw placement provides beneficial additional~     information to the operating surgeon to prevent misplacement of screws before it happens.~   "
178202|NCT01232504|"~     We conducted a prospective, multicenter, open-label randomized trial to compare the~     antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF),~     Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and~     rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.~   "
178203|NCT01232491|"~     This trial is conducted in Europe, and North and South America. The aim of this trial is to~     investigate if a dietary intervention has an effect on weight when initiating insulin~     treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs~     (OADs).~   "
178204|NCT01232478|"~     The iCARE study, a clustered-randomized controlled trial, is evaluating an adherence~     promotion intervention for adolescents that Cystic Fibrosis (CF) care teams will implement.~     Half the centers will receive the Comprehensive Adherence Program (CAP) for 2 years. CAP~     consists of training in the CF My Way program (a validated problem-solving adherence~     promotion intervention). The other half of the centers will receive CAP in year 2 of the~     study. Participants are patients age 11-20 years old who are diagnosed with CF and have been~     prescribed at least one of the following medications for at least 6 months prior to signing~     the informed consent: azithromycin, hypertonic saline, Pulmozyme®, TOBI®, or inhaled~     compounded tobramycin. Rate of refilling prescriptions is the primary outcome with lung~     function decline rates, exacerbation rates, and patient reported measures including health~     related quality of life and CF knowledge and skills, as secondary outcomes.~      A central goal of this study is to test the effectiveness of the comprehensive adherence~     program (CAP), described above, versus standard care (SC) for adolescents and young adults~     seen in outpatient CF clinics.~   "
178205|NCT01232465|"~     Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients~     undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any,~     between IVF success and sperm DNA integrity.~   "
178206|NCT01232452|"~     The primary purpose of this study is to evaluate the hypothesis that cixutumumab given in~     combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as~     first-line therapy for patients with advanced nonsquamous non-small cell lung carcinoma~     (NSCLC).~   "
178207|NCT01232439|"~     To measure the occupancy of brain kappa opioid receptors after single oral doses of~     LY2456302.~   "
178208|NCT01232426|"~     Intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually~     referred to as Mallet fractures. Treatment of Mallet fractures remains controversial.~     Although no differences in clinical results are reported between conservative treatment and~     operative treatment, operative treatment is suggested for fractures involving more than 30%~     of articular surface. There are many different operative techniques, all with specific~     disadvantages. The investigators hypothesis is that operative treatment of Mallet fractures~     with one Meniscus Arrow® has a better outcome than conservative treatment with a Mallet~     splint.~   "
178209|NCT01232413|"~     The objective of this study is to evaluate the effect of repeat oral dosing of ASP1941 on~     electrocardiogram (ECG) measurements.~   "
178210|NCT01232400|"~     The purpose of this study is to evaluate the clinical effect of esmolol treatment on cardiac~     function and electrophysiology; to assess the effects of esmolol treatment on serum~     adrenergic and cardiac biomarkers; to explore the safety of esmolol treatment shortly after~     subarachnoid hemorrhage (SAH). Patients will be followed for a maximum of 1 month after the~     index SAH. The primary outcome will be change in systolic function - ejection fraction by~     Simpson's rule (baseline versus Day 7 +/- 2 after SAH).~   "
178227|NCT01232179|"~     Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal~     photocoagulation (PRP) which can improve the visual prognosis in this complication~     significantly. However , the treatment may also resulting adverse effects such as blurring of~     central vision, visual field constriction and disturbance in dark adaptation and contrast~     vision. Extended targeted retinal coagulation (TRP) to the ischemic areas may cause~     regression of the neovascularization while minimizing some of the risks and complication~     associated of treatment of PDR with these two methods.~   "
178211|NCT01232387|"~     Objectives: 1) To determine risk factors for fetomaternal hemorrhage. 2) To identify a~     cost-effective method to detect fetomaternal hemorrhage prior to significant fetal anemia.~      Significance/Background: Fetomaternal hemorrhage (FMH) is a condition in which occurs when~     the placenta transfers blood from the fetus to the mother. Normally, nutrition and gasses~     pass from mother to baby through the placenta and only waste products pass from baby to~     mother through the placenta. Whole blood cells do not normally cross the placenta in~     significant amounts. Mild FMH, where a small amount of whole blood passes from fetus to~     mother but does not hurt the mother or baby, occurs in about 75% of pregnancies. A pregnant~     woman does not know this occurs. It is only discovered if a special blood test that is~     labor-intensive to perform and difficult to interpret called the Kleihauer-Betke acid elution~     test is done. As mild FMH hurts no one, this test is not part of routine care. In most cases,~     testing is done only if a baby is born sick with unexplained anemia. Severe FMH, which can~     cause the baby to become sick from anemia (low red blood cell count) is caused by large blood~     loss into the mother, occurs in only 1-3 per 1000 births. Severe anemia caused by FMH can~     result in death of the baby before or after birth, or significant illness in the newborn~     period. Short term problems for the baby include difficulty breathing, difficulty maintaining~     blood pressure, and difficulty providing oxygen to all parts of the body. This can cause~     multiple problems with the function of internal organs including the liver, kidneys,~     intestines, and brain. Babies who become sick from severe FMH can develop long-term problems~     including cerebral palsy (a lifelong problem with body movements) and/or mental retardation.~      It is not known why some pregnancies are affected by FMH and others are not. It is thought~     that FMH may occur more frequently now than in the past, but no one knows why. If identified~     early, FMH is readily treatable by blood transfusion of the baby before or after birth and/or~     early delivery. Current laboratory testing for FMH is difficult and expensive. There is great~     need identify high risk patients early in pregnancy in order to treat the condition before~     the baby gets sick.~      Approach: Five hundred women will be asked to participate in the study at the time they are~     admitted to the Mount Sinai labor floor for delivery at term. After birth, newborns of study~     mothers will be tested for anemia. Mothers of anemic babies will donate blood for~     confirmation of FMH by established laboratory methods as well as for development of a new~     laboratory screening protocol. All mothers will provide medical, social, environmental, and~     full pregnancy history. Risk factors for FMH will be identified by statistical analysis of~     this information.~   "
178212|NCT01232374|"~     Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor~     (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different~     indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck~     (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phase I~     study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in~     patients with local advanced esophageal squamous cell carcinoma (LAFSCC) has shown the safety~     and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial~     designed to assess the efficacy of the combination of Nimotuzumab administered concurrently~     with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect~     and toxicity.~   "
178213|NCT01232361|"~     The main purpose of this study is to find out how stimulant medications (methylphenidate or~     amphetamine/ dextroamphetamine) for the treatment of Attention Deficit Hyperactivity Disorder~     (ADHD)are processed in HIV-1 infected and HIV-uninfected children and adolescents.~   "
178214|NCT01232348|"~     The purpose of this study is to confirm the safety (ADR related to beta stimulant drugs,~     unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on~     bronchial asthma and Patient satisfaction~   "
178215|NCT01232335|"~     The purpose of this study is to confirm the safety profile for long term treatment and~     maximize doses and the control status on bronchial asthma in daily clinical usage~   "
178216|NCT01232322|"~     The purpose of this study is to investigate the safety and efficacy for long term treatment~     of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical~     usage.~   "
178217|NCT01232309|"~     Cardiovascular diseases (CVDs), especially atherosclerotic coronary heart disease and stroke,~     are the leading causes of death globally. Important risk factors for CVDs include elevated~     serum levels of total cholesterol, low-density lipoprotein(LDL)-cholesterol, triglycerides,~     and low high-density lipoprotein (HDL)-cholesterol. Elevated oxidized LDL, a~     pro-inflammatory villain, has also emerged as an important risk factor for the development of~     CVDs. There is a growing need to identify safe and effective nutritional interventions that~     offer a clinical benefit aimed at reducing one more of the risk factors for CVDs. Data from~     many studies in humans have shown various health benefits provided by dietary fiber intake,~     including an inverse association with the risk of developing cardiovascular disease. The~     primary purpose of this study is to determine whether daily consumption for 6 weeks of~     chitin-glucan, a fiber purified from a microorganism, is effective at reducing the amount of~     oxidized LDL in humans with borderline-to-high LDL-cholesterol. The effects of chitin-glucan~     on other cardiovascular risk factors will also be evaluated.~   "
178218|NCT01232296|"~     The purpose of this open-label, randomized, phase II study is to compare the safety and~     efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with~     advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the~     Asia-Pacific region.~   "
178219|NCT01232283|"~     This study will evaluate the effects of an experimental (being tested) study drug called~     apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and~     therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast~     and compare its effects to placebo (an inactive substance which contains no medicine but is~     in the same form as the drug). This study will test efficacy (improvement of signs and~     symptoms) and safety of apremilast in patients with moderate to severe psoriasis.~   "
178220|NCT01232270|"~     Since intrathecal fentanyl is known to sedation effect, intrathecal fentanyl will result in~     lowering propofol requirement for conscious sedation under spinal anesthesia.~   "
178221|NCT01232257|"~     Cardiovascular morbidity and mortality is high in CKD patients. Nitric oxide (NO) deficiency~     plays a crucial role in progression of CKD. This leads to endothelial dysfunction,~     hypertension, and inflammation. Hydrogen sulfide (H2S) could serve as a backup mechanism for~     NO deficiency in CKD. N-acetylcysteine (NAC) is a derivate of cysteine and this is the main~     substrate for H2S production. Therefore, NAC should enable us to stimulate H2S production in~     humans. Our objective is to investigate the effect of NAC on plasma H2S levels and on markers~     of oxidative stress, inflammation, and endothelial dysfunction in healthy volunteers, CKD~     patients, and dialysis patients. We hypothesize that there is an increase in H2S levels after~     treatment with NAC.~   "
178222|NCT01232244|"~     Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in~     response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon~     are all known to regulate parameters such as appetite, food intake and induce weight loss.~      Therefore we want to investigate mechanistic relations between the three hormones.~   "
178241|NCT01231997|"~     This study is designed to assess the effect of renal impairment on the pharmacokinetics,~     safety and tolerability of udenafil in subjects with renal impairment compared to healthy~     subjects.~   "
178228|NCT01232166|"~     Background: Endotracheal intubation has become a well established standard in protecting the~     airway during surgical procedures, and in emergency situations. Serious complications can~     occur from the incorrect placement of an endotracheal tube in a mainstem bronchus. If~     unrecognized it can lead to hypoxemia secondary to atelectasis of the unventilated lung and~     hyperinflation of the intubated lung, which can result in barotrauma. As bedside method the~     golden standard to verify the correct endotracheal tube placement is bilateral ausculation of~     the chest. However this is not always satisfactory, as breath sounds can be transmitted to~     the opposite side of the chest in spite of endobronchial intubation. Therefore other clinical~     tests to verify the correct endotracheal tube placement have become part of daily clinical~     practice, like observation of symmetric chest movements, and use of the cm markings printed~     on the endotracheal tube. However so far no study investigated which of these bedside~     clinical methods works best in detecting an inadvertently placed endobronchial tube in~     adults. We therefore designed a study to compare three different bedside methods to verify~     endotracheal or endobronchial tube placement.~      Objective: To determine which of four commonly used bedside methods of detecting inadvertent~     endobronchial intubation in adults has the highest sensitivity and specificity.~      Design: Prospective randomized, blinded study. Setting: Tertiary, academic hospital,~     department of anaesthesia. Participants: 160 consecutive ASA I or II patients, aged 19-75~     years, scheduled for elective gynaecological or urological surgery.~      Interventions: Patients were randomly assigned to eight study groups. In four groups, an~     endotracheal tube (ETT) was fiberoptically positioned 2.5-4.0 cm above the carina, whereas in~     the other four groups the tube was positioned in the right mainstem bronchus. The four groups~     differed in the bedside test used to verify the position of the endotracheal tube. First-year~     residents and experienced anaesthesiologists independently performed one of the following~     randomly assigned bedside tests in each patient in an effort to determine whether the tube~     was properly positioned in the trachea: 1) bilateral auscultation of the chest~     (Auscultation); 2) observation and palpation of symmetric chest movements (Observation); 3)~     estimating the position of the ETT by the insertion depth (Tube Depth); and, 4) a combination~     of all three mentioned tests (All Three).~      Main outcome measures: Correct and incorrect judgements of endotracheal tube (ETT) position~     as independently assessed by first-year anaesthesia residents and experienced~     anaesthesiologists with each of the four bedside tests.~   "
178229|NCT01232153|"~     Recent studies reports feasibility, effectiveness and even less complications of using NIV~     for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has~     been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate~     same results or even more in that conditions.~   "
178230|NCT01232140|"~     Rationale: Acute exacerbations are key events in chronic obstructive pulmonary disease~     (COPD), resulting in poorer quality of life. Causes include irritants, viruses and bacterial~     pathogens. These exacerbations are often treated with a combination of corticosteroids,~     bronchodilators and antibiotics, but the benefit of antibiotic therapy remains controversial.~     Several trials studying antibiotic treatment in AECOPD showed conflicting data, with several~     large studies failing to demonstrate superiority of antibiotic therapy over placebo. Other~     trials indicated that antibiotic therapy is effective in patients who have at least two of~     the following symptoms: increased dyspnoea, increased sputum volume and increased sputum~     purulence. Ever since sputum purulence has been used as a predictive marker in AECOPD, a~     strategy that has been integrated in the GOLD guideline for treatment of AECOPD. However, the~     color of sputum reported by patients is not always reliable and inspection of sputum is not~     always possible. Several serum biomarkers such as C-reactive protein (CRP) and procalcitonin~     (PCT) are now available. In a recent trial of doxycycline in addition to systemic~     corticosteroids for patients hospitalized with AECOPD we found that CRP might be valuable as~     a marker predictive of response to antibiotic treatment in AECOPD.~   "
178231|NCT01232127|"~     The purpose of this study is to assess the effects of famotidine, given twice daily, on~     atazanavir administered with ritonavir and tenofovir in HIV-infected participants.~   "
178232|NCT01232114|"~     Functional dyspepsia (FD) is a common functional gastrointestinal disorder and is steadily~     becoming a public health problem.Simotang is a classical formula that has been used to treat~     gastrointestinal disorders for hundreds of years [9] and was approved as an oral liquid drug~     by the Chinese National Food and Drug Administration in the 1980s.In this study,patients with~     functional dyspepsia were divided according to the inclusive criteria into treatment group~     and control group randomly, who were given Simo decoction or Domperidone tablets for 14~     days。And then the gastric emptying, Symptoms in plasma were observed before and after~     treatment in mult-center.~   "
178233|NCT01232101|"~     The study is investigator initiated. Tumors that gives the narrowing of the bile ducts~     prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk~     of bacterial growth in bile with severe infections as a result. Unresectable bile duct~     strictures have routinely been treated them with plastic stents. The plastic stents have been~     replaced by self expandable metallic stents.~      These stents remain open longer for reasons that they have a larger diameter so that the bile~     flows through more easily. One problem with these stents, however, is that the tumor growing~     through the wire mesh which forms the wall of the stent. This has led to the development of~     so-called covered stents. Whether covered stents have longer patency is unclear as well as~     whether they are as safe. There is reason to believe that covered stents remain open longer,~     but there may be an increased risk of migration and other complications.~      The purpose is to prospectively and randomized compare the two stent types. The study~     endpoint is the clogging of the stent or the patient's death. We also monitor complications,~     regress time of the jaundice and success rate of stent placement~   "
178234|NCT01232088|"~     Medication errors are common in intensive care (Valentin A et al., BMJ. 2009;338).~     Standardized color coded labels for user applied syringes enjoy strong support from many~     health professionals, thinking that this might increase patient safety. Whether this is true~     or not warrants further research.~   "
178235|NCT01232075|"~     The aim of this randomized controlled trial is to compare the efficacy of extended letrozole~     regimen (2.5mg/day from cycle day 1 to 9) with clomiphene citrate (100 mg/day from cycle day~     3 to 7) in women with unexplained infertility undergoing superovulation and intrauterine~     insemination .~   "
178236|NCT01232062|"~     To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with~     adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative~     metastatic breast cancer patients~   "
178237|NCT01232049|"~     This study is designed to evaluate a pharmacokinetic drug interaction and safety between~     Pitavastatin and Valsartan in healthy male subjects~   "
178238|NCT01232036|"~     This study is designed to to compare the pharmacokinetic and pharmacodynamic characteristics~     and safety after oral administration of Glucophage with those after oral administration of~     HL-018 in healthy male volunteers~   "
178239|NCT01232023|"~     This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of~     indobufen in healthy subjects.~   "
178240|NCT01232010|"~     This study is designed to investigate the effect of renal impairment on the safety and~     pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.~   "
178242|NCT01231984|"~     Anxiety about needles is a concern commonly expressed by diabetics when beginning insulin~     therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy~     profile of longer pen needles may appeal to many diabetic patients as the shorter needle may~     be perceived as less intimidating and more comfortable. While pen needles of 4 to 8 mm in~     length are generally used for insulin injection in patients considered thin or normal weight,~     longer (12.7 mm) needles are still often prescribed for overweight or obese patients with~     diabetes. Since skin thickness is nearly constant across a range of body mass index (BMI), a~     clear rationale exists for the use of shorter needles in obese patients. (Gibney et al., CMRO~     2010)~      The primary purpose of this study is to evaluate whether the BD Ultra-Fine™ Nano 4mm x 32~     Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent~     glucose control (as measured by hemoglobin A1c levels) as the BD Ultra-Fine™ 8mm x 31G and~     the BD Ultra-Fine™ 12.7mm x 29G pen needles in obese subjects with diabetes.~   "
178243|NCT01231971|"~     The purpose of this study is to build upon the information obtained in the original~     Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study~     funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how~     brain imaging technology can be used with other tests to measure the progression of mild~     cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the~     neuroscience of AD. This information will aid in the early detection of AD, and in measuring~     the effectiveness of treatments in future clinical trials.~   "
178244|NCT01231958|"~     The investigators long-term goal is to understand the complex interactions of diet and other~     behavioral and environmental factors, genetics, and psychosocial stress on the high and~     apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto Rican~     adults.~   "
178245|NCT01231945|"~     Background:~      - Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative~     to Pap smears and visual inspection for cervical cancer screening of underserved women. Two~     low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been~     developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3~     hours to run and may provide point-of-care (diagnostic testing at or near the site of patient~     care) testing for HPV. Researchers are interested in evaluating both tests to determine the~     best strategy for HPV testing of women who live in rural or underserved areas that have a~     high prevalence of cervical cancer diagnoses.~      Objectives:~        -  To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting~          cervical cancer and precancerous lesions.~        -  To evaluate the best low-cost test or combination of tests for women who have been~          referred for cervical cancer screening or treatment.~        -  To compare the clinical performance of self-collected specimens versus~          clinician-collected specimens in detecting cervical cancer and precancerous lesions.~      Eligibility:~      - Women between 25 and 65 years of age who live in rural China.~      Design:~        -  This study involves an initial testing visit and a 1-year followup visit for a high-risk~          subgroup.~        -  Participants will have the HPV E6 test, careHPV, and a visual inspection test for~          cervical cancer. For comparison, participants will also have the standard HPV test~          approved by the U.S. Food and Drug Administration.~        -  Participants who test positive for HPV on any of the above tests will also have~          colposcopy to collect samples of cervical tissue for further study.~        -  A random sample of women who test negative for HPV will also have colposcopy.~          Participants may also have biopsies if there is visual evidence of cervical~          abnormalities.~        -  At the 1-year followup visit, participants in the high-risk subgroup will have the same~          tests as in the previous visit..~   "
178246|NCT01231932|"~     Background:~      - Fatigue, a common side effect of cancer and its treatment, is found in up to 96% of cancer~     patients. Fatigue is difficult to treat because its cause is poorly understood. Research has~     indicated that cancer-related fatigue may be caused by a number of factors, including immune~     system responses to cancer treatment. Researchers are interested in studying individuals who~     are receiving cancer treatment in order to better understand the causes of fatigue.~      Objectives:~      - To study fatigue in individuals who are receiving cancer treatment.~      Eligibility:~      - Individuals at least 18 years of age who have localized cancer that has not spread and are~     scheduled to start cancer treatment at the National Institutes of Health.~      Design:~        -  This study involves an initial screening visit and a minimum of three outpatient visits.~        -  Participants will be screened with a medical history, and blood tests.~        -  Participants who are scheduled to have cycles of cancer treatment will be seen once~          before the start of each cycle, once at the midpoint of each cycle, and once at the end~          of each cycle. Participants whose treatment does not follow a cycle will be seen before~          the start of treatment; 2 weeks after starting treatment; and 1 month, 3 months, 6~          months, and 1 year after starting treatment, for a total of six outpatient visits.~        -  At each study visit, participants will complete the following tasks:~        -  Questionnaires about physical activity, fatigue, depression, and quality of life.~        -  Computerized cognitive tests of memory, attention, and ability to follow directions. The~          tests are timed to determine whether these brain functions are affected by cancer~          treatment and whether they occur with fatigue symptoms.~        -  Blood samples to monitor immune system and other responses to treatment.~        -  Hand grip strength test to evaluate physical strength.~        -  Physical activity monitor and journals to study how fatigue affects physical activity.~        -  Participants who need additional cycles of cancer treatment will continue to have visits~          until the end of the third cycle, for a maximum of nine outpatient visits.~        -  Treatment will not be provided under this study.~   "
178247|NCT01231919|"~     This phase I trial is studying the side effects, best way to give, and best dose of Akt~     inhibitor MK2206 (MK2206) in treating patients with recurrent or refractory solid tumors or~     leukemia. MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~   "
178248|NCT01231906|"~     This randomized phase III trial studies combination chemotherapy to see how well it works~     compared to combination chemotherapy with topotecan hydrochloride in treating patients with~     non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine~     sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy~     is more effective with topotecan hydrochloride in treating Ewing sarcoma.~   "
178249|NCT01231893|"~     The purpose of this experimental therapy is an assessment of the safety and feasibility of~     transplantation of autologous olfactory ensheathing glia and olfactory fibroblasts obtained~     from the olfactory mucosa in patients with complete spinal cord injury.~   "
178250|NCT01231880|"~     The investigators hypothesize that schoolchildren treated with IPT using DP over one year of~     follow-up will have a different risk of clinical malaria compared to those treated with~     placebo.~   "
178274|NCT01231568|"~     The study is designed to evaluate the effects of a high fat meal on the pharmacokinetics of~     150 mg of GSK2118436, as well as the effects of particle size on the relative bioavailability~     of GSK2118436.~   "
178275|NCT01231555|"~     This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects~     consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg~     once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The background~     ART for all 3 arms will be chosen by the Investigators and will be either abacavir/lamivudine~     [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC] fixed dose combination (FDC) tablets.~     Antiviral activity, safety, PK, and development of viral resistance will be evaluated.~   "
178437|NCT01229397|"~     The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL~     2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline~     for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as~     reference.~   "
178251|NCT01231867|"~     Patients who have experienced and survived non-ST segment elevation acute coronary syndromes~     are often prescribed a combination of aspirin and clopidogrel to thin the blood and prevent~     further acute coronary episodes. Both clopidogrel and aspirin may cause stomach bleeds and so~     a prophylactic proton pump inhibitor is frequently co-prescribed in order to prevent such~     bleeds. Recent mechanistic and observational studies suggest proton pump inhibitors may~     reduce the effectiveness of clopidogrel and so patients may not benefit as much as expected~     from combined aspirin and clopidogrel. The investigators propose a cohort study of patients~     prescribed clopidogrel + aspirin. Amongst these patients the investigators will measure the~     relative rate of acute coronary syndrome and death comparing patients with and without proton~     pump inhibitor treatment. To provide a more complete picture of the risks and benefits of~     treatment the investigators will also measure the relative rate of stomach bleeds in the same~     groups of patients. In addition, whether the inhibitory effect of proton pump inhibitors on~     the protective effect of clopidogrel is due to their inhibition of drug metabolising enzymes~     will be explored by assessing the effects of other drugs that inhibit the same enzymes.~   "
178252|NCT01231854|"~     The purpose of this study is to investigate the comparative efficacy, safety and efficiency~     of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.~   "
178253|NCT01231841|"~     RATIONALE: Immunosuppressive therapies, such as anti-thymocyte globulin and cyclosporine, may~     improve bone marrow function and increase blood cell counts. PURPOSE: This phase II trial is~     studying how well giving anti-thymocyte globulin together with cyclosporine as first-line~     therapy works in treating patients with severe aplastic anemia.~   "
178254|NCT01231828|"~     The project will improve scientific knowledge regarding a recent law applying potentially to~     every french driver. It will give for the first time an indication on the impact of alerting~     treatments on driving risks. It will reinforce the links between different research~     environments (sleep physiopathology, clinical research, cognitive neurosciences, drivers~     supervision, virtual reality, pharmacology) among the Réseau Eveil Sommeil Attention et~     Transports (RESAT) network.~   "
178255|NCT01231815|"~     Heart transplantation is the ultimate therapeutic option in patients with end-stage heart~     failure. Since advances in the treatment of acute rejection has increased early transplant~     survival, cardiac allograft vasculopathy (CAV) is the main factor limiting long-term~     survival. The prevalence of angiographically proven CAV is high, documented in 40-50% of~     transplant recipients 5 years after transplantation. Therefore, annual coronary angiography~     remains widely used to monitor transplanted patients, although pathologic studies and~     intravascular ultrasonography have demonstrated that coronary angiography underestimates the~     severity of CAV. Perfusion SPECT may underestimate allograft vasculopathy in case of diffuse~     coronary lesions. In this setting, the assessment of coronary reserve by means of Positron~     Emission Tomography (PET) and perfusion cardiac magnetic resonance imaging (CMR) have not~     been investigated.~   "
178256|NCT01231802|"~     The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast~     cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.~   "
178257|NCT01231789|"~     The current study is designed to clarify the neuroprotective effect of remote ischemic~     preconditioning on the patients underwent open-heart cardiac surgery.~   "
178258|NCT01231776|"~     Due to various causes, such as brain impairment, environment changes, anxious,et al.~     patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In~     chinese traditional medicine, acupuncture can improve the quality of sleep in patients with~     sleeping disorder. But it remains acupuncture could improve the quality of sleep in patients~     with heart operations.~   "
178259|NCT01231763|"~     This study is being done to find out what women would want in a film vaginal product for~     human immunodeficiency virus (HIV) prevention, especially what it should look like and how to~     apply it.~      The investigators hypothesize that women will prefer a smooth, clear, and rectangular~     quick-dissolve vaginal film for HIV prevention over a textured, opaque, square quick-dissolve~     vaginal film.~   "
178260|NCT01231750|"~     The purpose of this study is to test the hypothesis that application of topical capsaicin in~     patients with stable angina will result in improved exercise tolerance and reduced cardiac~     ischemia.~   "
178261|NCT01231737|"~     Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract~     infections risked recurrent infection. Urinary tract infection causes marked discomfort for~     the patient, has a negative impact upon quality of life, and is associated with high social~     and health costs in terms of specialist appointments, laboratory and instrumental tests and~     prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been~     proposed, doubts persist about the most efficacious pharmacological agents, duration of~     prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is~     suspended.~      Aims of the study:~        1. To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin):~             -  in reducing the number of urinary tract infection episodes during prophylaxis~             -  in reducing the number of urinary tract infection episodes after prophylaxis~             -  in improving the patient's quality of life .~        2. To assess :~             -  Tolerability of antibiotic prophylaxis~             -  The incidence of resistance to antibiotic therapy~   "
178262|NCT01231724|"~     The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is~     safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).~   "
178276|NCT01231542|"~     This study will be a phase I, open label, two arm, fixed sequence crossover study to~     investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of~     GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration.~     Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50~     mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600~     mg once daily for 14 days. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7~     days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14~     days. Serial PK sampling will be completed following the last dose of each treatment. Safety~     and tolerability will be assessed throughout the study through assessment of adverse events~     (AEs), and clinical laboratory tests.~      This study will be conducted at one center in the US with healthy adult male and female~     subjects.~   "
178263|NCT01231711|"~     Background: Current military involvement in Afghanistan (Operation Enduring Freedom - OEF)~     and Iraq (Operation Iraqi Freedom - OIF) has created unforeseen burdens on the mental health~     and well-being of US service women and men. Although OEF/OIF service members and veterans are~     at high risk of developing sub-threshold combat stress and depressive symptoms or full~     disorders in the post-deployment period, only a small fraction ever receive care. The VETS~     PREVAIL Intervention, which combines Cognitive-Behavioral-Therapy-based (CBT-based) coping~     skills training with peer-to-peer support and counseling, was specifically designed to offer~     the returning OEF/OIF service member or veteran an accessible and confidential first step to~     care.~      Evaluation Study: RISE Consulting, lead by Dr. Benjamin W. Van Voorhees, MD, MPH, was~     contracted to supervise a pilot study of potential benefit, feasibility and safety of the~     VETS PREVAIL Intervention. The study would consist of a single group pre/post comparison~     study of N=50 recent OEF/OIF veterans in the frame work of a phase 1 clinical trial (phase~     1). Feasibility (adherence and satisfaction), evidence of clinical benefit would be evaluated~     through changes in the following clinical self-report measures: i) symptoms of depressed mood~     (Center for Epidemiologic Studies Depression Scale, CES-D), ii) post traumatic stress~     disorder (Post Traumatic Stress Disorder Checklist-Military, PCL-M), and iii) functional~     status (Short Form 12, SF-12), as well as changes in key attitudes toward mental health care~     seeking (intent to seek treatment, mental health self-efficacy and stigma).~   "
178264|NCT01231698|"~     The purpose of this study is investigate the effects on systemic hemodynamics and organ~     function of esmolol when used to maintain heart rate below a predefined threshold in patients~     with septic shock.~   "
178265|NCT01231685|"~     HIV infection exerts a negative impact on the course of HCV infection. Co-infected~     individuals progress more rapidly to liver fibrosis, cirrhosis and ESLD compared to those~     infected with HCV alone. Some of the this accelerated fibrosis may be related to longterm~     chronic toxicity from protease inhibitor based ART.~      Hypothesis: Switching from ritonavir boosted-PI based ART regimen to a Raltegravir-based~     regimen will reduce the rate of hepatic fibrosis progression in HIV-HCV co-infected patients~     as measured by transient elastography (Fibroscan®) and the AST-to-platelet ratio index~     (APRI).~   "
178266|NCT01231672|"~     A prognostic score was proposed by the investigative team to predict death at 1 month. This~     score is based on certain biological markers, scored under emergency conditions in the first~     24 hours of routine clinical practice management for septic shock.~      The main objective of this multicenter study is to validate the performance of the score in~     terms of area under the ROC curve and negative predictive value.~   "
178267|NCT01231659|"~     This is a multi-center, Israeli phase II open label study evaluating treatment with RAD001~     (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence~     or progression on Tamoxifen, Anastrozole or Examestane.~      There are no treatments specifically approved after recurrence or progression on AIs.~     Available options, based on common clinical practice and several treatment guidelines (e.g.~     NCCN treatment guidelines 2008), include fulvestrant.~      Combining RAD001 with letrazole is a rational approach to the treatment of advanced Brest~     Cancer, offering the potential for inhibition of tumor cell growth\ proliferation and anti~     angiogenesis while at the same time potentially preventing the development of letrazole~     resistance.~   "
178268|NCT01231646|"~     Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth~     to infant with certain birth defects. However, some medications may affect the action of~     folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how~     folate works in our body.~   "
178269|NCT01231633|"~     The purpose of this study is to compare visual improvement and total number of intraocular~     injections in eyes with macular edema following central retinal vein occlusion (CRVO)after~     initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).~   "
178270|NCT01231620|"~     The purpose of this study is to test the safety and efficacy of zanamivir given intravenously~     and how well it works at two different doses in hospitalized adolescents and adults with flu.~     Zanamivir will be compared with oseltamivir, which is used for treating flu.~   "
178271|NCT01231607|"~     The purpose of this six month study is to show that dutasteride is safe and more effective~     than placebo, and at least as safe and effective as finasteride in treating hair loss in men~     with androgenetic alopecia. Three doses of dutasteride will be investigated.~   "
178272|NCT01231594|"~     This rollover study is designed to provide continued access to GSK2118436 for eligible~     subjects with BRAF mutation-positive tumors who have previously participated in a~     GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of~     progressive disease and who have tolerated GSK2118436 in the parent study without significant~     toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment~     received in their parent study. Safety assessments (physical examinations, vital signs,~     12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring~     of adverse events) will be made throughout the study. Clinical activity will be assessed~     using local standard of care imaging practices and the appropriate response criteria as~     determined by the investigator.~   "
178273|NCT01231581|"~     GSK1120212 is a potent and highly selective inhibitor of MEK phosphorylation and kinase~     activity and has demonstrated potent anti-proliferative activity against human pancreatic~     cancer cell lines. This study is a Phase II, randomized placebo-controlled trial of the MEK~     inhibitor GSK1120212 plus gemcitabine vs. placebo plus gemcitabine in subjects with~     metastatic pancreatic cancer. Eligible subjects will receive intravenous gemcitabine with~     oral GSK1120212 or placebo. Therapy will continue until treatment discontinuation criteria~     are met. The primary objective will be to compare the overall survival of subjects in the~     GSK1120212 plus gemcitabine arm vs. subjects in the placebo plus gemcitabine arm. Secondary~     objectives include comparison of progression free survival, overall response rate, and~     duration of response between the two arms. Exploratory research objectives include the~     evaluation of population pharmacokinetics as well as blood and tissue based biomarkers.~     Safety will also be monitored throughout dosing.~      Once the determined number of survival events has occurred, if subjects are eligible, they~     will have the option to enter MEK114375, an open-label, Phase Ib rollover study of GSK1120212~     monotherapy or GSK1120212 in combination with other anti-cancer treatments.~   "
178517|NCT01228357|"~     The purpose of this study is to determine whether genetic information associated with~     individual depressive symptoms.~   "
178277|NCT01231529|"~     GSK1349572 is an integrase inhibitor that is currently in clinical development for the~     treatment of human immunodeficiency virus (HIV) infection. GSK1349572 is metabolized~     primarily by uridine diphosphate glucuronosyltransferase (UGT)1A1 with a minor role of~     Cytochrome P450 (CYP)3A. Hepatic impairment could potentially alter the clearance and plasma~     protein binding of GSK1349572. This study will evaluate the single dose pharmacokinetics and~     safety of GSK1349572 in healthy subjects and in subjects with mild or moderate hepatic~     impairment based on Child-Pugh category.~      This is a single-dose, open-label, parallel group, two-part, adaptive study in adult males~     and females with mild or moderate hepatic impairment and matched, healthy control subjects~     with normal hepatic function. Healthy control subjects (16) will be matched for gender, age,~     and BMI to the subjects in the mild (8) or moderate (8) hepatic impairment category. In Part~     1, approximately 8 subjects with moderate hepatic impairment (cohort 1) and 8 matched,~     control subjects (cohort 2) will each receive GSK1349572 50 mg as a single dose in the fasted~     state followed by pharmacokinetic sampling for total concentrations of GSK1349572 in plasma.~     Free (unbound) plasma concentrations of GSK1349572 will also be evaluated at sparse, selected~     time points. If the geometric mean total plasma area under the concentration curve (AUC) of~     GSK1349572 is increased by > 2-fold in moderately impaired subjects compared to matched~     controls, Part 2 will be conducted to evaluate GSK1349572 pharmacokinetics in another group~     of subjects with mild impairment (8, cohort 3) and matched, control subjects (8, cohort 4).~     Vital signs, electrocardiograms (ECGs), and adverse events will be monitored throughout the~     study. A follow-up visit will occur 7-10 days after the dose of study drug.~   "
178278|NCT01231516|"~     ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel~     group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected~     antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to~     receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an~     investigator selected background regimen consisting of at least one fully active agent plus~     no more than one second single agent which may or may not be active. Antiviral activity,~     safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.~   "
178279|NCT01231503|"~     The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an~     efficacious malaria vaccine that is deliverable through the existing system, the Expanded~     Program on Immunization (EPI) of WHO. This study has been designed to:~        -  Investigate the safety and immunogenicity of 7 infant immunization schedules of the~          experimental malaria vaccine integrated with an EPI regimen.~        -  Investigate how to maximize the antibody response to the experimental malaria vaccine.~   "
178280|NCT01231490|"~     This is a methodological study designed to investigate a new model for testing pain agents in~     the treatment of patients with osteoarthritis (OA). This will be a double-blind, randomised,~     placebo controlled three-way cross-over study in patients with OA of the knee.~   "
178281|NCT01231477|"~     The aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and~     surgery on cytokines response.~   "
178282|NCT01231464|"~     The objective of this study is to compare the efficacy and safety of Fluticasone Furoate~     Nasal Spray (FFNS), that is FFNS with placebo in Chinese adult and adolescent subjects with~     Allergic Rhinitis as AR. There are 3 phases, 2 to14 day run in, 2 week treatment, and 3 to 5~     day follow up. After run in period, at least 360 subjects with AR ( ages of 12yrs and 65yrs,~     inclusive) will be randomised to receive FFNS 110ug once daily or placebo for 2 weeks. The~     primary endpoint is the change from baseline of reflective total nasal symptom score (rTNSS)~     during treatment period, and the secondary endpoints include mean change from baseline in~     nasal finding scores by rhinoscopy at completion of study treatment, and severity of overall~     inference in activities of daily living. Safety measures include AE (Adverse Event) reports,~     ECGs (Electrocardiograph), physical exams, vital signs, and nasal exam. In addition,~     reflective total ocular symptom score (rTOSS) will be measured as an explorative endpoint,~     only in the specific AR (Allergic Rhinitis) patients with severe ocular symptoms.~   "
178283|NCT01231451|"~     DMPA (depot medroxyprogesterone acetate or the 'depot' injection) is a widely used~     contraception. It is popular in woman with HIV as it probably still works when you take HIV~     drugs. HIV drugs can increase or decrease the level of other drugs (e.g. contraceptives) in~     your bloodstream which may make them work less well or increase side effects. It is assumed~     that DMPA can be given with HIV drugs there are no studies proving this.~      The purpose of the study is to investigate whether an HIV drug combination containing~     lopinavir/ritonavir affects DMPA when they are taken at the same time.~   "
178284|NCT01231438|"~     Patients with reduced renal function normally develop hyperparathyroidism, which in turn is~     associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may~     be enhanced by an increased level of FGF23 which is often seen in the early stage of renal~     failure. This pilot study will investigate the FGF23-lowering effect of early initiation of~     treatment with a phosphate binder versus active vitamin D in an open crossover design.~   "
178285|NCT01231425|"~     The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as~     adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical,~     thoracic and lumbar pain, under conditions of usual clinical practice as the medical~     acupuncturist performed acupuncture, with and without supplementary pharmacological treatment~     during the first 4 weeks of follow up.~   "
178286|NCT01231412|"~     This randomized phase III trial studies how well graft-vs-host disease (GVHD) prophylaxis~     works in treating patients with hematologic malignancies undergoing unrelated donor~     peripheral blood stem cell transplant. Giving chemotherapy and total-body irradiation before~     a donor peripheral blood stem cell transplant (PBSCT) helps stop the growth of cancer cells.~     It may also stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving total-body irradiation (TBI) together with fludarabine phosphate (FLU), cyclosporine~     (CSP), mycophenolate mofetil (MMF), or sirolimus before transplant may stop this from~     happening.~   "
183951|NCT01157000|"~     The purpose of this study is to evaluate the absolute oral bioavailability (how fast and how~     much study drug is absorbed in the body) of a single 300-mg oral dose of canagliflozin in~     healthy male volunteers.~   "
178287|NCT01231399|"~     RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood~     flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing, or by stopping them from spreading. Giving~     everolimus together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with combination chemotherapy in treating patients with metastatic stomach or~     esophageal cancer that has spread to other places in the body.~   "
178288|NCT01231386|"~     MicroRNAs (MiRNAs) regulate the translation of RNAs and are implicated in cell proliferation~     and renewal both under physiologically normal as well as in malignant conditions.~     Dysregulation of specific miRNAs may be associated with either gaining oncogenic or loosing~     tumor suppressing functions. MiRNA dysregulation has been implicated in breast cancer~     tumorigenic (stem cell) and non-tumorigenic development. Therefore, miRNA profiling of~     treatment naïve and treatment-exposed breast tumors and sequential samples of blood/serum~     will allow for identification of miRNA markers of prognosis and as indicators and potential~     targets for personalized therapies. In this proposal, specimens from patients treated in the~     clinical breast cancer program on already existing protocols (IRB 05091 and 05015) will be~     characterized by Dr. Rossi's laboratory and collaborators, and the information gained will be~     applied to develop specific therapies.~   "
178289|NCT01231373|"~     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and~     may cause discomfort. In this study, patients with varicose veins in the legs will be~     participating. The purpose of this research study is to evaluate the safety and effectiveness~     of three different concentrations of an investigational drug, Polidocanol Endovenous~     Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and~     appearance of varicose veins.~   "
178290|NCT01231360|"~     Specific Aim 1: To test the hypothesis that subjects with PAD and intermittent claudication~     have altered expression of genes that regulate skeletal muscle metabolism.~      Specific Aim 2: To test the hypothesis that exercise training improves calf skeletal muscle~     insulin resistance and genes that regulate skeletal muscle metabolic function in PAD patients~     with intermittent claudication.~   "
178291|NCT01231347|"~     AMG 479 is an investigational fully human monoclonal antibody that targets type 1~     insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important~     role in the regulation of cell growth and survival.~      Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is~     administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.~      The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall~     survival as compared to placebo and gemcitabine.~   "
178292|NCT01231334|"~     A study comparing the topical application of Aczone® plus Differin® versus Duac® plus~     Differin® in patients with severe facial acne (facial acne vulgaris).~   "
178293|NCT01231321|"~     A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5~     sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with~     dose escalation to weekly dosing available for participants not receiving concomitant~     disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of~     Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety~     measurements were performed throughout the study.~   "
178294|NCT01231308|"~     The study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass (RYGB) + optimal medical~     therapy versus Intensive lifestyle modification and optimal medical therapy in the treatment~     of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34kg/m2; the lower BMI~     cut-off will be 26kg/m2 in patients of Asian descent).~      This is a single center, prospective randomized study. The study at the Weill College Medical~     College Diabetes Surgery Center. This study is intended to be a pilot investigation whose~     results can inform clinicians and researchers for future larger or multi-site trials of~     diabetes surgery. This study will also be used for the definition of a core protocol for~     independent randomized clinical trials to be carried out at various centers participating in~     a multinational consortium.~   "
178295|NCT01231295|"~     The primary objective of this study is to characterize cerebral metabolism modifications~     using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal~     Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging~     within this framework, and search for optimal diagnostic thresholds.~   "
178296|NCT01231282|"~     Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique~     that characterizes tissue by probing changes in water diffusion secondary to differences in~     the tissue microstructure. These changes in water diffusion result in differences in signal~     intensity on diffusion-weighted images that are quantified with the apparent diffusion~     coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be~     diminished, due to the increased number of cells. This will restrict water diffusion,~     identified by increased signal intensity (SI) on native diffusion-weighted images and low~     ADC. Contrary, in tissue with low cellularity, like benign lesions and treatment induced~     necrosis, the EES will be enlarged due to the lower density of cells, or in case of necrosis,~     the complete absence of cellular organization. This will facilitate water diffusion, leading~     to absent SI on native diffusion-weighted images and high ADC.~      The purpose of this study is to image anatomy and lymph nodes in healthy volunteers with~     whole body diffusion-weighted imaging. This way maps of normal anatomy can be created on the~     whole body diffusion-weighted images which can be used as a reference in further studies with~     patients scanned with the same whole body diffusion-weighted imaging scan protocol.~      A group of 30 healthy volunteers will receive a whole body diffusion-weighted imaging scan on~     a 3 Tesla T-MRI system.~      A total scan session will take about 30 minutes. Contrast administration is not required and~     patients will not be exposed to radiation.~   "
178339|NCT01230710|"~     This open-label, single-arm study will evaluate the safety and efficacy of Tarceva~     (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who~     have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients~     will receive Tarceva at a dose of 150 mg orally daily until disease progression or~     unacceptable toxicity occurs.~   "
178297|NCT01231269|"~     Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique~     that characterizes tissue by probing changes in water diffusion secondary to differences in~     the tissue microstructure. These changes in water diffusion result in differences in signal~     intensity on diffusion-weighted-images that are quantified with the apparent diffusion~     coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be~     diminished, due to the increased number of cells. This will restrict water diffusion,~     identified by increased signal intensity (SI) on native DWI images and low ADC. Several~     studies indicate the value of DWI for differentiation of benign and malignant lymph nodes,~     detection of tumor recurrence and for ADC-based prediction of treatment outcome in various~     solid tumours (Koh DM et al, Am J Roentgenol 2007).~      Patients with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cell~     lymphoma, follicular lymphoma, mantle cell lymphoma and PTLD) will be included in the study.~     These patients will receive a WB-DWI scan before treatment, once or twice during treatment~     (depending on the type of lymphoma) and after the completion of the treatment. The MRI scan~     will be performed on a 3 Tesla-MRI system without contrast administration and without~     exposing the patient to radiation.~      Whole body diffusion-weighted images will be prospectively interpreted by two experienced~     radiologists, blinded to all clinical and imaging data. Findings will be correlated to~     FDG-18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose , biopsies performed in clinical~     routine (bone marrow always - soft tissue lesions if indicated) and imaging follow-up.~      The purpose of this study is:~        -  to evaluate Whole body diffusion-weighted imaging for staging of lymphoma~        -  to evaluate Whole body diffusion-weighted imaging as an early predictive biomarker for~          treatment outcome~        -  to evaluate Whole body diffusion-weighted imaging for differentiating residual tumor~          from post therapy changes~   "
178298|NCT01231256|"~     A new working method, i.e. a questionnaire completed at home followed by a patient-centred~     preventive health consultation with follow-up, can be used by all general practitioners (GPs)~     as a preventive offer to their patients with multiple problems in lifestyle, well-being or~     health behaviour, if this project is shown to be effective.~      The investigators use a broad preventive offer in a structured way to young adults with~     multiple psychosocial problems (a certain risk profile) found by a screening questionnaire~     when arriving to the clinic.~      The main hypothesis of the project is:~      By using the questionnaire and subsequent patient-centred health consultation the GP is able~     to support the participants to improve their resources, their well-being and self-estimated~     health. Subsequently, relevant changes in health habits and life situation might be initiated~     in order to prevent or reduce future problems or illness.~   "
178299|NCT01231243|"~     There is a controversy in the dentistry literature about how the use of associated light to~     activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the~     bleaching effectiveness. The studies that demonstrated an increased level of bleaching using~     light activation employed lower hydrogen peroxide gels while the ones reporting no~     statistical difference employed higher hydrogen peroxide gels.~      The hypothesis of this study is that the effectiveness of light activation tooth bleaching in~     dependent on the hydrogen peroxide concentration employed.~   "
178300|NCT01231230|"~     The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled~     glucocorticosteroid improves disease control in persistent asthma. This observation has~     supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination~     preparations for the management of asthma. Currently, salmeterol/fluticasone and~     formoterol/budesonide are available for clinical use. The long-term beneficial clinical~     effects of the two drug classes seem to be synergistic, and several mechanisms of~     glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been~     invoked to explain this phenomenon.This study, wish to address the question whether~     glucocorticoids can acutely potentiate the bronchodilator response to a long-acting~     beta-adrenergic agonist.We expect that in patients with asthma, the short-term bronchodilator~     effect of salmeterol is enhanced by the addition of fluticasone, which by itself has no~     short-term bronchodilator effect. To test this premise, we will assess the respective~     short-term effects of salmeterol (50 µg), fluticasone (250 µg), salmeterol/fluticasone~     (50/250 µg), and placebo/placebo on spirometric parameters. Airway Blood flow will also be~     measured to ensure that vasoconstriction does not occur.~   "
178301|NCT01231217|"~     The purpose of this study is to assess whether green tea or coffee influence the course and~     life quality of patients with mild to moderately active Crohn's disease.~   "
178302|NCT01231204|"~     Research study to determine if putting local anesthetic—or numbing medication—through a tiny~     tube placed next to the nerves that go to a breast prior to and following a mastectomy will~     decrease subsequent pain.~   "
178303|NCT01231191|"~     This is a research study to determine if giving acetaminophen intravenously in hte operating~     room will decrease the number of patients who require additional pain medicine, such as~     morphine, after surgery in the recovery room.~   "
178304|NCT01231178|"~     The project aims to examine the efficacy of a 12-week intake of alginate based ready to drink~     supplement on development in body weight and body composition, and risk markers for type-2~     diabetes and cardiovascular disease in obese subjects.~   "
178305|NCT01231165|"~     Treatment of coronary artery disease is a major health care problem across the entire word,~     and the United States. Unfortunately, despite a number of medical advances, diagnostic~     procedure, or epidemiological studies, the treatment of these patients remain complex, and~     and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United~     States and Canada documented that drug treatment, coronary interventions or both were not~     effective solution in coronary artery diseases.~      A novel approach has recently been developed, based on the critical role of the potassium (K)~     content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin~     (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the~     organs as the heart, the hemoglobin release both Oxygen and K ions.~      This apparently simple mechanisms occurs in human blood in all individuals but could be~     altered in subjects with acquired or hereditable defect in red-blood-cell K content. The~     purpose of this trial, thus, will be to evaluate the pharmacological effects of Amiloride on~     RBC K-uptake and transport and its impact on reversion of angina, electrocardiographic~     changes of myocardial ischemia and electrical regeneration of the heart in subjects with~     coronary artery diseases.~   "
178306|NCT01231152|"~     The aim of the study is to investigate the association of obesity with arterial blood~     pressure, atherosclerosis, target organ damage (heart, arteries, kidney) and insulin~     resistance in children and young adolescents.~   "
178307|NCT01231139|"~     This primary aim is to investigate the effect of paracetamol in reducing body temperature in~     patients who have sustained traumatic brain injury. This study is also investigating the~     safety of paracetamol in this patient population.~   "
178308|NCT01231126|"~     The purpose of this study is to evaluate the blood loss in induced vaginal delivery by~     misoprostol and caesarians section with induction attempt.~   "
178309|NCT01231113|"~     Malaria in pregnancy poses enormous public health challenges, contributing to significant~     maternal and infant deaths yearly. Adverse outcomes include maternal anaemia and low~     birthweight. Down regulation of cellular immunity increases pregnant women's susceptibility~     to malaria and mediate these adverse outcomes.~      The World Health Organization recommends treatment with artemisinin-combination therapy.~     Ghana uses quinine for malaria in first trimester pregnancies while artesunate-amodiaquine~     (AS-AQ) and quinine again are used in later trimesters. Recent amendments added~     artesunate-lumefantrine and dihydroartemisinin-piperaquine (DHA-PPQ) to the antimalarials~     used in the country. A high degree of safety and efficacy of DHA-PPQ is documented in several~     studies. DHA-PPQ, though not specified for use in pregnancy as of now, is accessible and~     available following its inclusion in the national malaria guidelines and may inadvertently be~     used to treat malaria in pregnancy. Paucity of data on DHA-PPQ use in pregnancy makes it~     pertinent to study its safety, tolerability and efficacy in pregnancy.~      We propose an open label, randomized controlled non-inferiority comparison of DHA-PPQ and~     AS-AQ for treatment of uncomplicated malaria in pregnancy in second and third trimesters to~     assess safety, tolerability and efficacy of DHA-PPQ. Outcomes of interest include~     PCR-corrected cure rates at days 28 and 42, maternal haemoglobin levels at days 14 and 42,~     prevalence of congenital abnormalities and pregnancy wastage. Proportions and percentages~     will be described at 95% Confidence Intervals and compared using chi-square tests. Parametric~     and non-parametric tests of significance will be applied as appropriate to determine~     significance of differences in outcomes between the treatment groups.~   "
178310|NCT01231100|"~     The purpose of this study is to investigate whether or not care guided by hospitalists~     equipped with hand-carried ultrasound echocardiography reduces the length of stay of general~     medicine inpatients who were referred for standard echocardiography.~   "
178311|NCT01231087|"~     Obese patients are going to be submitted to indirect calorimetry pre-operatively and we are~     going to repeat the same exam 6 months after bariatric surgery (post Roux-en-Y gastric Bypass~     surgery). They are going to do also body composition analysis in both moments.~      The investigators are going to compare the results to see if the bariatric surgery increases~     their energy expenditure.~   "
178312|NCT01231074|"~     Recent but limited short term studies have shown that Metformin can slow down weight gain in~     obese children and in children with psychotropic-induced weight gain, two distinct pediatric~     populations that are at risk for obesity related co-morbid conditions. The purpose of this~     study is to conduct a long term prospective pilot cohort study to investigate the use of~     Metformin to prevent or decrease weight gain in two cohorts of children: 1) children with~     psychotropic induced weight gain on Metformin and 2) children with BMI above the 95th~     percentile on Metformin. Both study populations will be enrolled in a lifestyle weight~     management program~   "
178313|NCT01231061|"~     Demonstrate the technical feasibility of treating spine metastases with image-guided~     radiosurgery/SBRT~   "
178314|NCT01231035|"~     The main objective of the project is to assess the long-term prognostic impact of residual~     platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with~     acute coronary syndrome undergoing invasive strategy.~      Follow-up length will be at least 24 months. The primary end-point of the study will be a~     composite of death, myocardial infarction, urgent target vessel revascularization, stent~     thrombosis or stroke.~   "
178315|NCT01231022|"~     The investigators want to know the role of Peripheral hematopoietic stem cell infusion in~     avoiding Drug Induced Liver Injury,and also try to research SNPs genotyping associated with~     Drug Induced Liver Injury.~   "
178316|NCT01231009|"~     Aim of present study is to determine whether corticosteroids and vestibular exercises are~     equal effective in the recovery of balance in patients with acute vestibular neuritis.~   "
178317|NCT01230996|"~     This will be the first study to assess the clinical feasibility of dose escalation with~     simultaneous integrated boost intensity-modulated radiotherapy for patients with locally~     advanced cervical cancer. Following screening to confirm eligibility patients will commence a~     six week treatment period. After this, patients will be followed up by visits to clinic every~     3 months for a period of 24 months (2 years). End of study is defined as 24 months after~     treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after~     treatment.~   "
178318|NCT01230983|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane~     may lessen the side effects of chemotherapy.~      PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without~     dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic~     leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.~   "
178319|NCT01230970|"~     This trial will assess the intratumoural pharmacological activity of BN83495 by changes in~     intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS)~     activity.~   "
178320|NCT01230957|"~     This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to~     elderly individuals at risk of exposure to Clostridium difficile because of impending~     hospitalization or residence in a care facility.~      Primary Objectives:~        -  To describe the safety profile of subjects in each of the study groups.~        -  To describe the immune responses elicited by toxoid A and toxoid B of subjects in each~          of the study groups.~      Observational Objective:~        -  To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.~   "
178321|NCT01230944|"~     This is a long-term follow-up of a prospective randomized trial comparing open and~     laparoscopic Nissen fundoplication.~   "
178322|NCT01230931|"~     Fractures of the acetabulum are considered rare in the general community, but are quite~     common in major metropolitan areas and tertiary care centers. These fractures are some of the~     most complex and challenging injuries to successfully treat in the orthopaedic field.~     Extensile surgical exposures are required to access this unique structure that comprises the~     cup of the hip joint. Large skin incisions, significant soft tissue dissection, and elevation~     of periosteum and muscle from the intact and fractured fragments are often required for~     anatomic reductions of the acetabulum and good outcomes. Thus, there are many sources of~     intra-operative bleeding that can sum up to require strategies aimed at preventing bleeding~     or replacing blood loss.~      Cell-saver and transfusion of allogeneic blood products can replenish blood loss. The use of~     cell-saver is a good solution, but it is quite expensive. Trained perfusionists are required~     and cost over $400 per hour. Disposable products are also required for each patient. While~     blood loss can be great, often not enough blood is captured, processed, and available for~     return transfusion. Allogeneic blood transfusion is often routine. Appropriate blood is often~     on short supply. The cost of processing, testing, and transfusion is also high: minimum of~     $260 per standard unit of packed red blood cells. While risks of disease transmission are~     rare, they exist and can have serious consequences to patients. Transmission can include CMV~     (common), Hepatitis C (1:1,600,000), HIV (1:1,800,000), and bacteria (1:500,000). Transfusion~     reactions are more common and include febrile reactions (1:100), allergic reactions (1:100),~     hemolytic reactions (less common), and transfusion-related acute lung injury (1:5000).~      Decreased operative times, aggressive electrocautery, ligation of identifiable vessels,~     minimal soft tissue dissection or stripping, topical agents such as gel foams, and thrombins~     are possible and available. But still, significant blood losses persist. Over the past~     decade, platelet gel products and fibrin sealants have been developed and provide another~     possible solution. There are some retrospective studies in the arthroplasty literature~     indicating these are good hemostatic agents. There is also some literature from the general,~     oral and maxillofacial, and spine surgical fields indicated these topical agents decrease~     intra-operative blood loss. But there are no large prospective, randomized studies in~     orthopedics, particularly traumatology, supporting the use of surgical hemostats.~      This study protocol will use one surgical hemostat (Vitagel, Stryker). The study is a~     prospective, randomized controlled trial to evaluate this type of topical agent's role as a~     hemostatic agent in certain acetabular fracture types that require a non-extensile, posterior~     approach. Three fellowship-trained traumatologists will be involved: Drs. Milan Sen, Tim~     Achor, Josh Gary, Mark Prasarn, John Munz, and Andrew Burgess. Dr. Ambrose will assist in~     analyzing the data and statistical outcomes.~      Purpose of Project. The purpose of our study is to determine whether surgical hemostats can~     minimize blood loss, need for allogeneic blood transfusions and their associated risks, and~     costs in patients with certain acetabular fractures requiring operative fixation via a~     non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other topical~     agents like platelet gel products have also been linked with improved wound healing, a~     secondary endpoint will be incidence of wound dehiscence and/or infections.~      The investigators primary hypothesis is the topical hemostat will result in lower blood~     losses intraoperatively and fewer units of perioperative blood product transfused.~   "
178340|NCT01230697|"~     The study includes the recruitment of patients with advanced renal cells carcinoma and~     hepatocarcinoma in treatment with sorafenib. Multicenter cohort study. It is a prospective~     observational study.~   "
178341|NCT01230684|"~     The purpose of the study is to compare two different types of imaging techniques to identify~     endoleaks. Following the endovascular procedure, subjects are seen at one month to have~     computed tomographic angiography (CTA) to confirm the graft is not leaking (endoleak). CTA is~     the standard imaging technique used to identify endoleaks. This study will investigate if the~     image technique color duplex ultrasound with contrast enhanced ultrasound (CEUS) is a good~     tool to identify endoleaks too.~   "
178323|NCT01230918|"~     The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI)~     can serve as a marker for scar formation as detected by contrast-enhanced MRI during the~     process of myocardial remodelling after the ischemic insult.~      Comparison of ACS and HCM Populations:~      The primary objective is to determine whether TcNC100692 imaging is able to quantify the~     extent to which myocardial fibrogenesis occurring early post myocardial infarction differs~     from that in patients with hypertrophic cardiomyopathy.~      The primary hypothesis is that since fibrogenesis is known to occur most intensely in the~     first days to weeks post myocardial infarction, while it is a more protracted, less~     predictable process in HCM, there will be significantly more TcNC100692 uptake in the early~     post-ACS population than in the HCM population.~      Control Population:~      Normal control images will allow for differentiation of uptake in the myocardium.~   "
178324|NCT01230905|"~     Suppression of effects of androgens with male sex hormones, androgen suppression treatment~     (AST), has been known to reduce deaths and prolong life in advanced prostate cancer. There~     have, however, been concerns raised in previous studies that androgen suppression may be~     associated with increased rate of heart attacks, particularly in older men. This study looks~     at prostate cancer patients in The Ottawa Hospital Cancer Clinic to see if treating these~     patients with androgen suppression is associated with a decrease in blood flow to the heart~     muscles by using Positron Emission Tomography (PET) and brachial artery ultrasound.~   "
178325|NCT01230892|"~     Nebivolol is a novel blood pressure lowering drug with an additional effect on the inner~     lining of blood vessels to release a compound called nitric oxide that can relax blood~     vessels. Atenolol is a blood pressure reducing agent without the ability to release nitric~     oxide and effect additional blood vessel relaxation.~      The goal of this proposal is to compare Nebivolol and Atenolol with respect to the following~     parameters:~        -  Plaque within arteries supplying the heart in terms of its volume and composition as~          assessed by ultrasound within these arteries.~        -  Ability of small arteries in the heart to open up and deliver an enhanced blood supply~          in response to drug called Adenosine (routinely used in the cardiac catheterization~          laboratory) as assessed by pressure and flow detecting catheters within these arteries.~        -  Ability of the inner lining of arteries that supply the heart to release a relaxing~          compound called nitric oxide in response to injection of Acetylcholine (also used in the~          cardiac catheterization laboratory) as assessed by squirting dye into these arteries~        -  Local forces that affect blood flow in the arteries supplying the heart as assessed by~          superimposing the above data into complex maps created offline at Georgia Institute of~          Technology.~      It is likely that Nebivolol causes the plaque within arteries supplying the heart to change~     from the 'vulnerable' type to the 'stable' type plaque. There are several features of~     vulnerable plaques that can be detected in arteries of the heart using intravascular~     ultrasound (a small ultrasound camera that goes in the arteries of the heart). The~     investigators hypothesis is that Nebivolol will prove superior to Atenolol in reducing~     'vulnerable plaques', improve blood flow within the small arteries and the health of inner~     lining of these arteries at the 1 year time point. The investigators plan to enroll 20~     patients into the study (26 patient including dropouts) who will be randomized in a 1:1~     manner to Nebivolol Vs Atenolol for 1 year and repeat evaluation at that time point.~   "
178326|NCT01230879|"~     The aim of the study is to investigate the relationship between aging and morphological~     changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for~     this trial.~   "
178327|NCT01230866|"~     The purpose of this study is to compare the effects (good and bad) on patients with prostate~     cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks)~     with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of~     the treatments are similar or better.~   "
178328|NCT01230853|"~     The purpose of this study will be to evaluate the safety and tolerability of BAN2401 at~     sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).~   "
178329|NCT01230840|"~     To compare calcium and magnesium absorption within subjects with and without chronic~     consumption of wheat dextrin.~   "
178330|NCT01230827|"~     The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in~     patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with~     active arthritis that have poor response to methotrexate.~   "
178331|NCT01230814|"~     This research study is about vaginal infections such as bacterial vaginosis, yeast~     infections, and trichomoniasis. Usually, these infections can be treated with medication, but~     sometimes they come back after treatment. Researchers want to know if using vaginal~     suppositories can decrease the risk of vaginal infections. Participants will include 234~     women who are sexually active (greater than or equal to 4 episodes of sex with men during the~     past month), HIV-negative, 18 to 45 years old, with bacterial infection [vaginosis and/or~     vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis] detected by laboratory testing~     at a screening visit. Women will receive vaginal suppositories containing drug or inactive~     ingredients (placebo). Participation in the study will be about 12 months. Study procedures~     include: urine and blood tests, physical exams, and questionnaires.~   "
178332|NCT01230801|"~     A Phase 1/2, open-label, multicenter, multiple dose escalation study of BMN 701 administered~     by intravenous infusion every 2 weeks over a 24-week treatment period to patients with~     late-onset Pompe disease.~   "
178333|NCT01230788|"~     This is a pilot study of a drug called rituximab used together with other drugs—prednisone,~     etoposide, and ifosfamide. Prednisone, etoposide, and ifosfamide have been used as part of~     standard chemotherapy for relapsed Acute Lymphoblastic Leukemia (ALL). Rituximab was approved~     by the Food and Drug Administration in 1997. However, the use of rituximab with prednisone,~     etoposide, and ifosfamide in pediatric patients with relapsed or refractory ALL is considered~     experimental.~      This study is for patients who have ALL in second or greater relapse, or in first relapse and~     not responding to treatment.~      The goals of this study are:~        -  To see if using rituximab with prednisone, etoposide, and ifosfamide is beneficial to~          leukemia treatment~        -  To find out what side effects this combination of drugs can cause~      A total of 15 participants (30 years old or younger) will be enrolled, over a period of 2~     years.~   "
178334|NCT01230775|"~     This is a multicenter, phase III, randomized, subject and sponsor-blinded, placebo-controlled~     study to determine the treatment effect of Anagrelide retard in subjects with Essential~     Thrombocythaemia (ET) at defined risk (definition of risk criteria: see Inclusion Criteria~     Section 5.1) The study is planned as a 2-stage procedure according to Bauer and Köhne: After~     recruitment of 140 subjects an interim analysis with re-assessment of sample size is planned~     in an adaptive manner.~      As the confirmatory analysis will be based on a time-to-event evaluation (i.e. time to 1st~     clinically significant ET related event), there is no stipulated observation time identically~     applying for all subjects. Yet, with an interim analysis being performed after having~     recruited 140 subjects - which is expected to be reached after 1 year - the estimated~     observation time for a subject in stage I will also be about 1 year. (Details are explained~     in the section Statistical Considerations).~      Subjects will be randomized in a 1:1 ratio to one of the following two arms:~      Group A: Anagrelide retard Group B: Placebo~      An a priori stratification is planned for the JAK-2 mutational status. For exploratory~     purposes a post hoc stratification is used for obtaining covariate adjusted results, for the~     following other potentially predictive factors: sex, age, Factor V Leiden, and BMI.~      Dosing will be started with 1 tablet per day for week 1 and will be titrated up according to~     response (platelet reduction) to 2 tablets in week 2. Dosing may be further increased or~     decreased according to platelet response in week 3 and 4. However, the maximum dose is 4~     tablets (=8mg) per day. After week 4, the maximum dose to achieve optimal platelet counts~     (<450 G/L) should be maintained (for visit schedule see study flow chart section IV).~      To verify a treatment response, platelet counts must be evaluated at every visit. The~     platelet count values will be withheld from the subjects for the duration of stage I or stage~     II respectively. The subjects have to agree explicitly to this procedure by signing the~     Informed Consent form.~      This is a patient and sponsor-blinded clinical study. The trial medical is packaged in the~     blinded fashion to keep the patient unaware (blinded) towards the actual treatment group they~     were randomized to. The sponsor functions (including medical monitor, pharmacovigilance~     manager, clinical project manager, trial data manager and trial statistician) with stay~     blinded in the course of the study until the database lock. Randomization scheme will be~     prepared by an independent statistician (not otherwise involved in the study), and will be~     stored securely with no access to it by the sponsor functions mentioned above. The process of~     randomization (provision of the individual drug-allocation information to the subjects) will~     be carried out by a trained staff by Harrison, in adherence to the procedures to keep the~     other blinded functions unaware of this information (blinded). Unblinding envelopes, which~     contain the treatment code per patient number for identification of treatment in case when a~     safety-relevant unblinding needed, will be stored at the sponsor's site. At the end of the~     study, verification of the extent of maintaining the blind by checking if the envelopes have~     been broken, will take place and will be properly documented. If the sealed envelope will~     broken to provide treatment identification, the date of breaking the code, the initials of~     the person who broke the code and the reason will be stated on the envelope.~      The operational details on the blinding procedures are outlined in the relevant working~     guidelines (ARETA Study Working Guideline for idv staff and ARETA Study Working Guideline for~     Harrison, each in its current version).~      Investigator will not be blinded in this study, i.e. in case of a medical need individual~     patient management will be driven by the full knowledge of the trial related interventions.~     For the case, the sponsor will need to unblind a patient (e.g. due to safety reasons), the~     above mentioned (in this section) envelopes will be used.~      Only treatment naïve subjects, in respect to cytoreductive drugs with confirmed diagnosis of~     ET (centralized re-evaluation according to WHO, 2008; see Section 6.2.1) and assessment of~     JAK-2 status (centralized re-evaluation of JAK-2 status; see Section 6.2.2) will be enrolled.~      As described above, stage I of the study will be considered as closed as soon as 140 subjects~     have been recruited. The duration of stage II depends on the result of the re-assessment of~     sample size.~      Once stage I is finished, stage I subjects will enter into an extension period for a maximum~     of three years.~   "
178335|NCT01230762|"~     The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid~     ejaculation.~   "
178336|NCT01230749|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the~     body does to the medication) and pharmacodynamics (what the medication does to the body) of~     treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus~     participants.~   "
178337|NCT01230736|"~     The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from~     prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination)~     pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.~   "
178338|NCT01230723|"~     The objective of the study is to assess the superiority of the everolimus-eluting stent~     (Endeavor Resolute®) compared with the everolimus-eluting stent (XIENCE V®) regarding~     uncovered stent strut segments.~   "
178342|NCT01230671|"~     Breast Cancer is the most common cancer amongst Canadian women. Studies report that breast~     cancer patients are the most likely to use complementary medicine within the oncologic~     population. Yoga has become especially popular with this group as it promises to improve the~     mind, body and soul holistically. The investigators yoga program specifically focuses on~     rebuilding physical strength, increasing flexibility and reducing the pain and stress~     associated with the post-operative period. This study will examine how yoga can help improve~     the overall quality of life and its effects on the physical well-being of women with breast~     cancer. With positive statistical results, the investigators hope to implement yoga as part~     of their rehabilitation services at the Cedars Breast Clinic.~   "
178343|NCT01230658|"~     The purpose of this study is to assess anti-factor Xa concentrations in patients given~     prophylactic enoxaparin after bariatric surgery.~   "
178344|NCT01230645|"~     RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic~     rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 is~     effective in reducing the inflammation caused by viral infections such as RSV (respiratory~     syncytial virus).~   "
178345|NCT01230632|"~     This study is to compare the effects of high fat overfeeding on metabolic risk factors in~     children born though assisted reproduction technologies (ART) versus children conceived~     naturally (controls). The investigators will utilize state of the ART measures to~     characterize the physiological, endocrine and molecular responses to high fat overfeeding.~      The investigators hypothesize that children conceived following ART will have greater~     responses to high fat dietary challenge and that this will be associated with DNA~     hypermethylation of genes that are involved in lipid metabolism.~   "
178346|NCT01230619|"~     RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic~     rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568~     ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with seasonal~     allergic rhinitis.~   "
178347|NCT01230606|"~     This is a multi-center trial that will evaluate the safety, feasibility, and cost~     effectiveness of discharging patients, who have had successful percutaneous coronary~     intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24~     hours after the procedure. Patients will be randomized in a 3 (test): 1 (control) fashion and~     will have a study population of 600 patients over 6 investigational sites all within the~     United States. Patients <65 years old will be chosen in order to stay within the low risk~     group and will be followed up after 24 hours, 7 days, and 30 days via phone or office visit.~     The primary endpoint will be a composite of major adverse cardiac and cerebral events, and~     the incidence of major bleeding or vascular complications. Data acquired from the study, such~     as blinded financial information and patient satisfaction surveys, will be used in order to~     evaluate cost analysis and safety of the procedure.~   "
178348|NCT01230593|"~     An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the~     blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a~     typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The~     chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute~     to its morbidity. There are many anecdotal first line treatments for this condition,~     including warm compresses to the eyelid, topical antibiotics, topical steroids, topical~     combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to~     compare the efficacy of any of these conservative treatments. We wish to determine the most~     effective conservative medical treatment for chalazia.~   "
178349|NCT01230580|"~     The PIVOT trial aims to determine whether a strategy of switching to PI monotherapy is~     non-inferior to continuing triple-therapy, in terms of the proportion of patients who~     maintain all the drug treatment options that were available to them at baseline after at~     least 3 years of follow-up, and to compare clinical events, safety, toxicity and health~     economic parameters between the two strategies.~   "
178350|NCT01230567|"~     50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult~     etiology for the wound.~   "
178351|NCT01230554|"~     The objective of this one week, single group, bilateral, open-label study is to evaluate the~     product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test)~     when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted~     soft contact lens.~   "
178352|NCT01230541|"~     Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects~     on semen characteristics.~   "
178353|NCT01230528|"~     Reactive thrombocytosis (RT) in pediatric patients is common, but usually without symptoms.~     The incidence of RT is different depending on age. Mostly, we reasoned that RT is a~     phenomenon, nevertheless the diagnostic value of RT is little known. Therefore, the aim of~     this study was to determine the association of RT and clinical or laboratory characteristics~     in pediatric diseases.~   "
178354|NCT01230515|"~     The purpose of this study is to modify the opioid titration order sheet to meet the needs of~     the outpatient hospice population and to conduct a pilot trial to assess feasibility,~     utility, and derive preliminary efficacy data.~   "
178355|NCT01230502|"~     To determine whether long-term maintenance therapy with a single drug (Myfortic) applied~     using advanced immunologic monitoring tools in selected patients can lead to superior native~     kidney function at 2 years without resulting in increased acute rejection episodes or~     deterioration of liver allograft function.~   "
178356|NCT01230489|"~     To evaluate the efficacy of honey as a post surgical exit site care process to promote~     healing and prevent infectious bacterial colonization of newly created exit sites. It has~     been shown in the medical literature that honey has properties that are conducive to healing~     and the prevention of infection. In one study it was demonstrated that in urethral injury in~     the rat treated with honey the injury healed with none of the usual formation of fibrous~     tissue seen in such healing processes, that there was no reduction in the luminal diameter~     usually seen, and that the cells lining the urethra were uncompromised in any way, i.e.~     totally normal and healthy. We feel that if an exit site can be healed quickly with good~     normal tissue being developed that the patient will have a much better chance to keep that~     exit healthy reducing time, cost, and disruption of lifestyle. Other positive aspects of~     honey are it has the low pH required for good healthy tissue healing, it works in the~     presence of wound fluids, and it has never been shown to produce a resistant bacterial~     strain.~   "
178357|NCT01230476|"~     Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent~     cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma~     cells with high EGFR protein expression, may enhance the effectiveness of radiation and~     result in better tumour control. This study investigates the addition of 2 cycles of~     cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent~     with radiation, for treatment of locally advanced nasopharyngeal carcinoma.~   "
178358|NCT01230463|"~     The primary aim of this study is to show the non-inferiority of 15 mg intraoperative dose of~     ketorolac as compared to the standard 30 mg ketorolac by looking at the VAS scores 4 hours~     after an adult spine surgery.~   "
178359|NCT01230450|"~     Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study~     for comparing the relatively new Single incision sub-urethral tapes with the standard~     surgical treatment of female urodynamic stress incontinence (USI).~   "
178360|NCT01230437|"~     The airways of the lung are lined by specialised cells called airway epithelial cells. As~     well as being at the interface between the lungs and the air we breathe; airway epithelial~     cell (AEC) function is altered in people with respiratory diseases such as asthma. AEC~     secrete many mediators that contribute to asthma symptoms and these also contribute to~     asthmatic inflammation in the lungs. The study of such cells is difficult because of their~     location deep in the lungs. Nasal airway epithelial cells provide a useful and easily~     accessible model of model of lower airway cells. This study will examine whether the asthma~     medication Singulair (montelukast) can inhibit the inflammatory secretions of nasal AEC of~     asthmatic patents who also have allergic rhinitis compared with patients who have asthma~     alone. We will also examine if montelukast has differential modulating effects in these two~     patient groups.~   "
178361|NCT01230424|"~     A steroid (triamcinolone) 40 mg will be compared to placebo in a randomized~     placebo-controlled clinical trial testing the effect of this steroid versus placebo given~     into the study knee joint that has osteoarthritis (OA). The knee injection will be given once~     every 12 weeks over two years for a total of eight knee injections. How well each participant~     tolerates each injection and all the injections over time will be assessed. The safety of~     getting a knee injection every 12 weeks will be assessed by collecting reported adverse~     effects, knee examinations, and clinical laboratory tests. Participants will complete~     questionnaires, X-ray, MRIs, and bone density tests as part of this study.~   "
178362|NCT01230411|"~     This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the~     treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in~     subjects who are treated with study medication between 2 and 72 hours from time of onset of~     headache.~      Periodic safety and efficacy assessments will be performed prior to and after study drug~     administration.~      Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment~     groups (active treatment and placebo) who have pain relief at 2 hours after the completion of~     the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain~     level from severe or moderate decreased to mild or headache-free, respectively.~   "
178363|NCT01230385|"~     Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate~     the safety and toleration of 2 different doses of lersivirine administered either fed or~     fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD~     (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be~     evaluated.~   "
178364|NCT01230359|"~     Nutritional supplements like vitamin B6 and magnesium have demonstrated to have beneficial~     effects in patients with autism spectrum disorders (ASD). The underlying theory for these~     effects is that specific metabolic pathways in neuronal cells, e.g. the methionine cycle,~     will be more balanced. Most studies have been focused on the clinical outcome with this~     treatment. The present proposal will examine the effects on the different intermediates of~     the methionine cycle (methylation and transulfuration capacity), suggested to play an~     important role for the pathogenesis of ASD. The design is a prospective pilot study,~     including 40 patients, aged 2-6 yrs, with newly diagnosed ASD. All participants will receive~     the supplement (vitamin B6, magnesium; Kirkman formula) and placebo in a cross over design.~     Metabolites in blood and urine will be measured prior to and at the end of the treatments in~     the different groups. The results will then provide us with information, which will link~     clinical outcomes with biological markers. Furthermore, the study has also the potential to~     shed light on the pathogenesis of ASD.~   "
178365|NCT01230346|"~     This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at~     high risk for hereditary breast or ovarian cancer. A culturally-informed counseling~     intervention may be an effective method to help people learn more about their cancer risk.~   "
178366|NCT01230320|"~     BACKGROUND: The fabrication of complete dentures traditionally involves a series of complex~     technical procedures. Those procedures include two impressions for each jaw, the registration~     of the relationship between the upper teeth and the patient's head and usually two~     appointments for tooth try-in. However, recent studies have questioned the real need for such~     complex procedures. Simplified methods could have similar results if compared with~     conventional ones, and dentures would be delivered faster and with lower costs.~      OBJECTIVES: This study aims to compare the effectiveness complete dentures fabricated with a~     simplified or conventional method.~      METHODS: Eighty edentulous patients who requested treatment by maxillary and mandibular~     complete denture in a public dental clinic inside the University of Sao Paulo - Ribeirão~     Preto Dental School will be randomly divided into two groups. Group S will receive new~     dentures fabricated by a simplified method, whereas Group C will received new dentures~     according to a conventional method. Participants will complete a questionnaire for denture~     satisfaction and the oral health-related quality of life, 3 and 6 months after treatment. At~     the same time, a specialist in dental prostheses will evaluate the quality of new dentures.~   "
178367|NCT01230307|"~     The central objective of this proposal is to establish that vitamin D supplementation in~     heart failure patients with low vitamin D levels will have improved outcomes compared to~     placebo. In addition the investigators will also evaluate the role of genetics in regard to~     vitamin D and heart failure. The investigators will be evaluating what is currently a novel~     approach of identifying patients with low vitamin D and treating this low vitamin D level.~     The investigators will be able to evaluate the importance of vitamin D supplementation in~     these patients and the role of genetics on our defined outcomes.~   "
178369|NCT01230281|"~     This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after~     administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma~     concentration of C3G and the antioxidative markers such as total antioxidative capacity and~     attack of free oxygen radical will be measured.~      Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg~     black bean seed coat extract.~      This study, as an exploratory trial, does not required statistical hypothesis~   "
178370|NCT01230268|"~     This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after~     administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma~     concentration of C3G and the antioxidative markers such as total antioxidative capacity and~     attack of free oxygen radical will be measured.~      Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg~     Mulberry fruit extract.~      This study, as an exploratory trial, does not required statistical hypothesis.~   "
178371|NCT01230255|"~     Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) have~     traditionally been treated surgically through emergent laparotomy. Intensivist-performed~     bedside drainage of free intra-peritoneal fluid or blood [percutaneous catheter decompression~     (PCD)] has been suggested as a less-invasive alternative to traditional open abdominal~     decompression (OAD). This study assesses the relative efficacy of PCD vs. OAD in reducing~     elevated intra-abdominal pressure (IAP).~   "
178372|NCT01230242|"~     This study aims to demonstrate that the expulsion rate is increased but acceptable when~     inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The~     investigators will compare the postplacental insertion expulsion rate estimate with rates~     reported in the literature for 6 week postpartum insertion, which is currently the American~     standard for IUD insertion postpartum. Secondary outcomes will also be examined;~     endometritis, uterine perforation, continuation and pregnancy among others.~   "
178373|NCT01230229|"~     The aim of this study is to evaluate whether primary stenting with self expanding stent in~     patients with peripheral arterial disease suffering from stable claudication due to~     superficial femoral artery disease results in improved patient outcomes, compared to~     conservative treatment alone as measured by improvement in Quality of Life scores at 12~     months after treatment using established surveys. Patients will be followed up 24 months~     after treatment. Planned recruitment and randomization of 100 patients was completed June~     2015.~   "
178374|NCT01230216|"~     The purpose of this study is to evaluate the effect of intensive blood pressure control~     compared to standard blood pressure control on progression of coronary atherosclerosis by~     intravascular ultrasound in hypertensive patients with coronary artery disease.~   "
178375|NCT01230203|"~     Cumulative radiation dose, cost, contrast induced nephrotoxicity and increased demand for~     computed tomography aortography (CTA) suggest that duplex ultrasonoraphy (DU) may be an~     alternative to CTA-based surveillance. The investigators compared CTA with DU during~     endovascular aneurysm repair (EVAR) follow-up.~      Patients undergoing EVAR have radiological follow-up data entered in a prospectively~     multicenter database. The gold standard test for endoleak detection was CTA. DU~     interpretation was performed independently of CTA and vice versa.~   "
178376|NCT01230190|"~     To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD~     in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and~     has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in~     young children (beyond the conventional treatment).~   "
178377|NCT01230177|"~     This survey is conducted to investigate safety and efficacy under the post marketed drug~     utilization on the patient with rheumatoid arthritis (only for patients with an inadequate~     response to prior conventional therapy) at the time of switching regimen from 10 mg twice a~     week administration to 25 mg once a week administration.~   "
178378|NCT01230164|"~     An aberrometer measures visual aberrations by mapping how light rays travel through the eye~     and by providing maps using colored gradients to represent the magnitude of refractive errors~     of the eye.~      The purpose of this study is to compare 4 different aberrometers -Wavescan (Visx Technology),~     Zywave (Bausch & Lomb), Ladarwave aberrometer (Alcon Inc.) and Allegro Analyzer (Alcon Inc).~     In particular, the investigators propose to focus on the ability of these devices to display~     the higher order visual aberrations and to compare the quality of outputs from these 4~     devices in normal healthy subjects.~   "
178379|NCT01230151|"~     The purpose of this study is to assess the cognitive performance in patients with advanced~     Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined~     clinically to settings derived from a patient-specific computational model.~   "
178380|NCT01230138|"~     The purpose of this trial is to investigate the efficacy and safety of different doses and~     dose administrations of FP187 compared to a placebo treatment in patients with moderate to~     severe plaque psoriasis.~   "
178381|NCT01230125|"~     The objective of this clinical study is to compare the safety and efficacy of Mapracorat~     Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain~     following cataract surgery.~   "
178382|NCT01230112|"~     Study to examine the role of ITGAM molecule in normal control subjects with known genetic~     variation in the ITGAM gene.~   "
178383|NCT01230099|"~     The purpose of this study is to test a communication intervention to support family~     decision-making for patients with chronic critical illness.~   "
178384|NCT01230086|"~     Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary and~     secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for~     sensing and defibrillation capabilities of the ICD system is performed. Modern implantation~     strategies suggest a non-testing approach because net-benefit of a testing versus a~     non-testing strategy is questionable and because arrhythmia induction and defibrillation may~     cause micro damage to the heart.~      The study aims to investigate the contribution of different steps in the ICD implantation~     procedure (implantation of the lead, shock delivery and induced ventricular fibrillation)~     with respect to their potential damage to the heart measured by high sensitivity (HS)~     TroponinT.~   "
178662|NCT01226459|"~     This is a six month clinical trial to evaluate the effectiveness and safety in women with~     Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation~     applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.~   "
178385|NCT01230073|"~     Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new~     development in ICD therapy and has been shown to be technically feasible and safe.While data~     on safety and feasibility of remote monitoring are in favour of this technology, patients´~     treatment satisfaction has not been sufficiently investigated. To date, there is only one~     small, non-randomised study investigating patients´ treatment satisfaction in highly selected~     and highly motivated patients at the time of implantation and 12 months thereafter7.~     Therefore, the aim of the San Remo Trial is to investigate factors that are associated with~     patients´ willingness to accept the new method of follow-up on a broad basis of ICD~     recipients and to determine their treatment satisfaction with ICD therapy in a randomised,~     prospective trial.~   "
178386|NCT01230060|"~     The objective of this study is to evaluate the safety and effectiveness of the enVista®~     One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the~     visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens~     has been removed by an extracapsular cataract extraction method (eg, small incision~     phacoemulsification).~   "
178387|NCT01230047|"~     This is a quasi-experimental evaluation of psychoeducational course focusing on mindfulness~     and lifestyle changes for depression and anxiety; clients in active treatment group are~     compared to those in a treatment-as-usual wait-list control group. The primary hypothesis is~     that the psychoeducational course will result in lower levels of depression and anxiety as~     compared to the wait-listed treatment-as-usual comparison group.~   "
178388|NCT01230034|"~     Numerous clinical and experimental data show that the elective treatment of diabetic~     nephropathy should be based on drugs that inhibit the renin-angiotensin system (RAS).~     Albuminuria is a marker of risk not only renal but also cardiovascular and diabetic patients~     with concomitant non-diabetic nephropathy, on the other hand, drugs blocking the~     renin-angiotensin system available so far, namely ACE inhibitors and angiotensin antagonists~     II have proven effective in reducing proteinuria in power even if different therapeutic drug~     to drug. ACE inhibitors are one of the most known and used treatment options for blocking the~     renin-angiotensin system in patients with microalbuminuria. Drugs such as enalapril,~     lisinopril and ramipril are standard therapy in diabetic patients with micro or~     macroalbuminuria. However, it is still unclear whether their efficacy is, from this point of~     view, the same or varies from drug to drug. This is particularly true in the diabetic~     microalbuminuria, a condition in which there is sufficient documentation to prove that~     ramipril is effective. The main objective of this study was to assess the magnitude and trend~     of the time and to the antiproteinuric effect of antihypertensive 10-20mg/die imidapril~     versus ramipril 5-10 mg / day in hypertensive patients with type 2 diabetes and~     microalbuminuria.~   "
178389|NCT01230021|"~     This trial is conducted in Europe and United States of America (USA). The aim of this~     clinical trial is to investigate the pharmacokinetics (at which rate the substance is~     distributed and eliminated from the body) and the safety profile of catridecacog (recombinant~     factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children~     (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.~   "
178390|NCT01230008|"~     The use of Rituximab has been proposed to be useful and avoid the use of radiotherapy in~     diffuse large B-cell lymphoma with bulky disease.We assess efficacy of adjuvant radiotherapy~     in patients treated with R-CHOP~   "
178391|NCT01229995|"~     CAD/CAM technology has been introduced to the field of implant dentistry in the beginning of~     1990's (Priest 2005). Since their introduction, the use of CAD/CAM technology in the~     production of dental implant restorations has been rapidly expanding. However, little~     evidence is currently present supporting its clinical viability (Henriksson 2003, Canullo~     2007).~      Therefore, the suggested prospective randomized study includes bone level placed Straumann~     implants restored with transmucosal elements and crowns fabricated using either CAD/CAM~     Etkon technology (Zirconia abutment and ceramic crown) or a conventional technique~     (Crossfit titanium abutment and a ceramometal crown).~      The aim of this randomized controlled clinical trial is to examine single-tooth implant~     restorations in the esthetic zone. An esthetic area is defined as any area that is visible in~     the patient's full smile. [3rd ITI consensus conference 2004] The rehabilitations will be~     fabricated using two different techniques. Zirconia CAD/CAM (ZCC) implant restorations~     (tests) will be compared to Titanium conventionally-fabricated (TCF) implant restorations~     (controls) using, reproducible esthetic (objective/subjective) and biologic parameters.~      This in vivo study is a randomized study with two groups of 15 patients with one implant each~     for a total of 30 patients and 30 implants. The implants will be examined for successful~     tissue integration according to the criteria of success (Buser et al. 1990) at every recall~     visit.~      In addition, the following parameters will be evaluated for each restoration:~        -  Esthetic: A. Objective: PES/WES Score (Belser et al. 2009) from 1:1 digital photograph,~          study casts, and spectrophotometric measurements, and B. Subjective: VAS questionnaire~          for patients and VAS questionnaire from experts.~        -  Biologic (mPI, mB, simplified GI, microbial sample, periapical radiograph for DIB, and~          width of keratinized facial mucosa)~      Finally, an evaluation of the mechanical, biologic and technical complications will be~     performed at every recall visit. Mechanical complications would be defined as those~     complications that involve the prosthesis such as abutment screw loosening, fracture of the~     veneer material, fracture of the crown framework, abutment screw fractures, and implant~     fractures. The category of biologic complications will include those complications that~     involve the soft tissues (e.g., fistula, suppuration, bleeding, gingival inflammation, and~     soft tissue dehiscence). Technical complications are defined as those related to restorative~     components and crowns (e.g. crown emergence profile, abutment and crown fit, screw loosening,~     ceramic fracture).~   "
178392|NCT01229982|"~     The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in~     subjects with ocular hypertension or open-angle glaucoma.~   "
178393|NCT01229969|"~     Accidental falls in older adults are highly prevalent and a major source of morbidity. Over~     30% of people aged 65 or older fall each year with about half of these cases being recurrent.~     Falls may result in head trauma, bone fractures, and even death and are leading cause of both~     nonfatal and fatal injuries in older adults. The Nintendo Wii Fit is a suite of exercise and~     fitness video games using a balance board periphery developed for the Wii console. The~     purpose of this study is to determine the feasibility and validity of the Nintendo Wii Fit,~     in detecting balance problems in older community dwelling adults.20 ambulatory older adults~     will be recruited to participate in this study.Subject will be asked to complete 1 study~     visit. In this visit information will be gathered about the subjects overall health including~     fall assessments. Qualified subjects will be randomized into two study groups where one group~     will begin the study with Wii Fit testing followed by NeuroCom EquiTest evaluation and the~     other group in reversed order.~   "
178394|NCT01229956|"~     RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from young patients~     with acute myeloid leukemia.~   "
178822|NCT01224353|"~     The purpose of the study is to evaluate the efficacy on overall neuropathic sensory symptom~     improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in~     Chinese diabetic patients with distal symmetric polyneuropathy (DSP).~   "
178395|NCT01229943|"~     This randomized phase II trial studies how well everolimus and octreotide acetate with or~     without bevacizumab works in treating patients with pancreatic neuroendocrine tumors that~     cannot be removed by surgery and have spread nearby or to other places in the body.~     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Octreotide acetate may interfere with and slow the growth of tumor cells. Monoclonal~     antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and~     spread. Bevacizumab and everolimus also may stop the growth of pancreatic neuroendocrine~     tumors by blocking blood flow to the tumor. It is not yet known whether giving everolimus and~     octreotide acetate together is more effective with or without bevacizumab in treating~     pancreatic neuroendocrine tumors.~   "
178396|NCT01229930|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Cediranib maleate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known~     whether carboplatin and paclitaxel are more effective when given with or without cediranib~     maleate in treating patients with cervical cancer that cannot be removed by surgery.~      PURPOSE: This randomized phase II trial is studying giving carboplatin and paclitaxel~     together with cediranib maleate to see how well it works compared with giving carboplatin and~     paclitaxel together with a placebo in treating patients with metastatic or recurrent cervical~     cancer that cannot be removed by surgery.~   "
178397|NCT01229917|"~     The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus~     rhamnosus GG during rhinovirus infection.~   "
178398|NCT01229904|"~     Post traumatic Stress disorder (PTSD) is a common condition for persons who have served in~     the Armed services during combat or deployment. Treatments include medications, cognitive~     behavioral therapy, and other social support mechanisms.~      Our aim in this project is to critically evaluate the effects of a novel music therapy~     intervention on the symptoms of PTSD. Estimates developed by the Global Burden of Disease~     Study reveal that mental illness accounts for over 15% of the burden of disease on health and~     productivity in established market economies--more than the disease burden caused by all~     cancers combined.[1] Perhaps no industry has had the burden of mental disorders affect its~     labor force as severely and pervasively as the Armed Forces.~      Post-Traumatic Stress Disorder (PTSD) is a common sequelae of severe emotional trauma that is~     often associated with combat exposure. The condition has been well documented in returning~     soldiers and is characterized by recurrent and distressing thoughts and feelings related to~     the trauma, persistent avoidance of reminders of the trauma, and increased arousal that~     disturbs sleep, concentration, and the ability to modulate anger. Persons suffering from PTSD~     often have difficulty relating to others, leading to loneliness and isolation, which further~     intensifies their psychiatric symptoms. Current treatment options for PTSD include~     psychotherapy, medication management, or a combination of those. Although these treatments~     have been shown to be effective, returning soldiers are often hesitant to seek and adhere to~     mental health therapies. PTSD-related avoidance, including difficulty trusting, may serve as~     a barrier to seeking or completing treatments. Furthermore, some PTSD medications have~     unacceptable side-effects in some individuals. The need is great, therefore, to identify and~     promote safe, effective strategies for self-management of PTSD among Veterans.~   "
178399|NCT01229891|"~     The aim of this study is to evaluate the possible effects of daily intake of yogurt drink~     fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic,~     metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).~   "
178400|NCT01229878|"~     This is a double-blind placebo controlled pilot study to determine if vitamin D~     supplementation in hemodialysis (HD) patients will improve physical function and cognition.~     HD patients have a high prevalence of vitamin D deficiency, cognitive impairment, and~     physical impairment. Despite standard clinical care with active IV vitamin D during dialysis,~     HD patients still have markedly low levels of nutritional or dietary vitamin D. IV treatment~     with vitamin D during dialysis is aimed at treating HD related bone disease. Recent~     literature shows that oral or nutritional vitamin D has multiple extra-skeletal effects~     including improvement in cognition and physical function. In this study, the investigators~     plan to administer oral vitamin D to vitamin D deficient HD patients already receiving~     standard care with IV vitamin D therapy. Patients will be randomized to receive either~     placebo or 50,000 IU of vitamin D (cholecalciferol) weekly for 6 months. The investigators'~     specific aims are to 1) Assess the benefits of correcting nutritional vitamin D deficiency on~     cognitive and physical function in HD patients receiving routine standard of care, 2) Assess~     the feasibility of recruiting HD patients for this study, and 3) Evaluate the proposed~     regimen for safely and effectively increasing nutritional vitamin D levels with oral~     supplementation. The investigators anticipate that correction of nutritional vitamin D~     deficiency to optimal levels will improve the high prevalence of cognitive impairment and~     physical impairment in this population. These results will be used as evidence to support a~     larger study aimed at treating nutritional vitamin D deficiency in all patients receiving HD.~     These results may also contribute to a change in current guidelines which place little~     emphasis on the monitoring and treatment of nutritional vitamin D levels in HD patients.~     These results are important for the Veteran dialysis population since many of them are~     required to perform high-level cognitive tasks such as management of complex medical regimens~     and physical tasks such as orchestrating independent transportation to and from HD sessions~     and multiple physician appointments.~   "
178401|NCT01229865|"~     The purpose of this study is to examine the safety and evaluate the response of VB-111 on~     DTC.~   "
178402|NCT01229852|"~     Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic~     stimulation technology which may provide a drug-free method for treating fibromyalgia.~      The purpose of this study is to determine the effectiveness and the durability of effect of~     Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women~     diagnosed with fibromyalgia.~   "
178403|NCT01229839|"~     TACE is considered the standard treatment for unresectable HCC on the basis of the fact that~     there are no alternative to curative procedures.But the optimal combined regimen is still~     unclear. One of the controversy is do the protocol should contain lipiodo and how to~     executer. The investigators hypothesize that TACE without mixing the chemotherapy with~     lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.~   "
178404|NCT01229826|"~     The purpose of this study is to gain additional information regarding use of Magnetic~     Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the~     investigators will use a new noninvasive technology, MRE, to further characterize the elastic~     properties of the uterine fibroids. To date, very little is known concerning how the tissue~     composition of the uterine fibroid may affect its treatment with Magnetic Resonance Guided~     Focused Ultrasound (MRgFUS).~      In this study, the investigators will use a new noninvasive technology, magnetic resonance~     elastography (MRE), to further characterize the elastic properties of the uterine fibroids.~     This information will be gathered during routine magnetic resonance imaging for symptomatic~     uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic~     Resonance Imaging(MRI) can be more difficult to treat.~      This information will be gathered during routine magnetic resonance imaging for symptomatic~     uterine fibroids.~   "
178663|NCT01226446|"~     Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The~     investigators hypothesize that the correction of hypovitaminosis D before the initiation of~     anti-HCV combination therapy and the maintenance of an optimal vitamin D status during~     antiviral therapy could improve the antiviral efficacy~   "
178405|NCT01229813|"~     Patients with metastatic colorectal cancer will be treated with chemotherapy according to~     investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will~     be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients~     KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment,~     patients who has responded (complete response/partial response versus stable disease) will be~     randomized to maintenance treatment. Patients with KRAS WT will be randomized to either~     bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be~     randomized to either bevacizumab, or metronomic capecitabine. Translational research is~     performed, with purpose to find predictive factors in blood and tumor tissue.~   "
178406|NCT01229800|"~     : In several studies comparing of sodium phosphate solutions versus PEG, both regimen had~     similar efficacy of bowel cleansing and sodium phosphate solutions are more acceptable to~     patients because patient are required to consume smaller volume. But sodium phosphate~     solutions are associated with fluid and electrolyte disturbances, so use of sodium phosphate~     solution in routine medical check-up of outpatients is problematic. PEG can provide a rapid~     peroral approach to colon lavage without causing fluid and electrolyte disturbance. However,~     the need to ingest a large volume of fluid reduces patient compliance, and results in~     suboptimal bowel preparation. In order to overcome this disadvantage, several studies proved~     that split dose of PEG regimens were better quality preparation and more acceptable than~     single dose regimens. In Korea, need for outpatient or screening colonoscopy without~     laboratory test is increasing and split dose of PEG is used more frequently than other~     country in bowel preparation because of safety. But, superiority of split dose of PEG to~     sodium phosphate solution has not been demonstrated. The study was not yet existed about~     comparison of split dose PEG solution with sodium phosphate solution for bowel cleansing and~     tolerability in colonoscopy preparation. To use split dose of PEG in bowel preparation with~     medical evidence, we want to demonstrate split dose bowel preparation with PEG compared to~     sodium phosphate solutions provide a better colon cleansing efficacy and similar~     tolerability.~   "
178407|NCT01229787|"~     Obesity has been recognized as a risk factors for developing asthma. In a cohort of 5384~     children aged 15-17, we aim to:~        1. To investigate the association of asthma prevalence at age 15-17 with body mass index~          (BMI) at age 15-17 and BMI at age 11-12 years Part II~        2. To investigate the association of BMI in adolescence and BMI at age 11-12 years with:~             1. Prevalence of allergic sensitization~             2. Lung function~             3. Levels of airway inflammation at age 16-18 years~             4. Severity of asthma~      Secondly, to assess diet and physical activity involvement as effect modifiers in these~     possible associations.~   "
178408|NCT01229774|"~     The primary aim of this study is to test if etoricoxib decreases the perioperative blood loss~     compared to diclofenac.~      Secondary questions to be explored are:~        -  Does etoricoxib prevent Heterotopic ossification after Total Hip Arthroplasty as well as~          diclofenac ?~        -  Do diclofenac and etoricoxib both reduce pain at rest and on movements?~        -  Does etoricoxib compared to diclofenac reduce the amount of rescue medication~          (Oxycodon)?~        -  Does etoricoxib improve gastrointestinal tolerability compared to diclofenac?~   "
178409|NCT01229761|"~     The purpose of this study is to find ways to improve infant health and survival among infants~     whose mothers are HIV-infected but who do not themselves have HIV.~   "
178410|NCT01229748|"~     The investigators propose a randomized controlled trial with five aims: 1. To investigate the~     engagement potential and effectiveness of a family-centered intervention (MDFT) and Family~     Motivational Interviewing Intervention (FMII)/group for teens with alcohol-related crises; 2.~     To explore differential treatment effects with comorbid adolescents; 3. To examine the role~     of motivation and family factors as treatment mediators; 4. To examine long-term abstinence,~     patterns and predictors of relapse up to 18 months follow-up; and 5. To compare the total and~     net monetary benefits to society of MDFT, FMII/group, and standard care.~   "
178411|NCT01229735|"~     To assess the long-term effects of levetiracetam on retention rate in subjects with~     refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant~     antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.~   "
178412|NCT01229722|"~     The main aim of this phase II proposal is to continue and complete development of a cellular~     phone-based system that assists patients with their medication adherence. Adherence reports~     will be developed with feedback from patients and providers. Software for patients to report~     their four day recall adherence through text messaging or short message service (SMS) or~     interactive voice response (IVR) will be built. An initial qualitative study will evaluate~     the adherence reports, 4-day adherence recalls, and inform the development of content for~     reminder text messages that could be resistant to user fatigue. A redesigned system will be~     tested through a 3-week longitudinal study of 15 patients with human immunodeficiency~     virus/acquired immunodeficiency syndrome (HIV/AIDS). An intervention module will have an~     analytics engine to track adherence levels and personalize delivery of reminder messages. A~     clinic appointment module will perform patient appointment reminders. The final system with~     these modules will be tested through a 24-week efficacy study. A total of 115 patients and~     providers will be involved in the three user studies.~   "
178413|NCT01229709|"~     This study is a randomized, controlled trial of Mindfulness Based Tinnitus Reduction (MBTR)~     vs. Treatment As Usual (TAU). This study aims to determine patient's benefit from~     participating in an 8-week MBTR program as measured by a reduction in clinical symptoms, if~     present, and a tinnitus symptom perception shift. Sixty-four tinnitus patients who have~     previously received Tinnitus Counseling (TAU) at the UCSF Audiology Clinic under the~     direction of Robert Sweetow, PhD will be invited to participate in the MBTR study. Subjects~     will be randomly assigned to the experimental and control groups of 32 each. All subjects~     will have received Tinnitus Counseling at least 6-months prior to entry into the study.~     Tinnitus symptom activity and discomfort as well as psychological outcomes will be assessed~     by self-report questionnaires. The primary outcome measure is the Tinnitus Handicap Inventory~     (THI) measuring tinnitus symptom severity. The secondary outcome measures include the~     Tinnitus Visual Analogue Scale (TVAS), the Symptom Checklist-90-Revised (SCL-90-R), Hamilton~     Anxiety and Depression Scale (HADS), and the Five Factor Mindfulness Questionnaire (FFMQ). In~     addition to tinnitus symptom severity, secondary outcome measures are used to measure change~     in mindfulness and other clinical symptoms such as anxiety and depression, if they exist. The~     experimental group will complete measures at pre-, post-, at 3-months and 12-months~     follow-up. A 12-month follow-up assessment will be conducted with the experimental group to~     identify any enduring effects of the treatment. The control group will fill out measures at~     pre-, post-, and 3-month time periods. The 12-month follow-up will be conducted with the~     experimental group only and will be the uncontrolled portion of the study.~      The purpose of this study is to 1) Design and execute an MBTR program for patients with~     tinnitus within the UCSF Department of Audiology. 2) Determine patient's benefit from~     participating in an 8-week MBTR program as measured by a decrease in tinnitus distress, and a~     reduction in clinical symptoms (i.e., depression, anxiety), if present. 3) Compare the~     responses on study measures to those of the control group. 4) Collect follow-up data at 6-~     and 12-months post intervention to assess enduring effects, if any, in the experimental~     group. 5) Use the data and patient feedback to modify UCSF's Audiology program and guide~     future programming in regards to the treatment and care of patients with tinnitus.~   "
178416|NCT01229670|"~     Heart failure (HF) is a major and increasingly common cardiovascular syndrome, and is the end~     result of many cardiovascular disorders. It has been reported that HF patients with~     pharmacological therapy often remain burdened by dyspnea and fatigue, diminished exercise~     tolerance, reduced quality of life, recurrent hospitalizations, and early mortality. HF is~     associated with neurohumoral changes as the body attempts to reverse the effect of reduced~     cardiac output and organ perfusion. Persistent neurohumoral excitation, however, actually~     results in deterioration of myocardial function with inflammatory response, end-organ damage,~     and skeletal muscle derangement, which lead to worsened exercise capacity.~      Physical training can have beneficial effects on neurohumoral, inflammatory, metabolic and~     central hemodynamic responses, as well as on endothelial, skeletal muscle and cardiovascular~     function, leading to improvement in functional capacity and quality of life. All these~     training-induced changes can effectively counteract the progression of deleterious~     compensatory mechanisms of HF.~      Several lines of evidence suggest greater aerobic and cardiovascular adaptations after~     high-intensity exercise than with moderate levels in patients with coronary artery disease or~     left ventricular dysfunction function and in healthy subjects. Aerobic interval training~     (AIT) involving periods at 90% of VO2peak has been shown to rescue impaired cardiomyocyte~     contractility, attenuate myocardial hypertrophy, and reduce myocardial expression of atrial~     natriuretic peptide in animal model of post-infarction heart failure. However, underlying~     mechanisms of AIT-improved regulations remain unclear.~      The different effects of AIT and moderate continuous training (MCT) on hemorheology,~     atherothrombosis or angiogenesis modulated by erythrocyte, monocyte or EPC in patients with~     CHF have been not investigated yet. Accordingly, the investigators will conduct this~     three-year study to clarify how the two exercise trainings affect cardiovascular~     hemorheological characteristics and atherothrombosis/ angiogenesis-related variables in~     patients with chronic heart failure. The investigators expect that these results obtained~     from this study can aid in determining appropriate exercise intervention to improve aerobic~     fitness as well as simultaneously improve hemodynamic control and minimize the risk of~     thrombogenesis in patients with CHF.~   "
178417|NCT01229657|"~     To evaluate the anatomic and visual outcomes in patients with initially closed macular holes~     after vitreoretinal surgery and with one to seven years of follow-up.~   "
178418|NCT01229644|"~     The purpose of this study is to evaluate the antitumor efficacy of crenolanib (CP-868,596) in~     patients with recurrent high grade glioma and in patients with low grade glioma.~   "
178419|NCT01229631|"~     The objective of this study is to determine whether enhanced micronutrient intake in the form~     of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in~     chronic periodontitis patients prior to standard non-surgical treatment.~   "
178420|NCT01229618|"~     Current imaging options do not assess prostate cancer well. This study will combine two~     magnetic resonance imaging modalities, MRI and MRSI, in order to determine the utility to~     physicians and patients with prostate cancer in making treatment decisions and seeing how~     well various types of treatment work. Hyperpolarized pyruvate (13C) is an investigational~     product that may enhance the imaging capability of MRI and MRSI. Hyperpolarized pyruvate will~     be injected into the body to determine how it is metabolized and how it's metabolism can be~     assessed using MR imaging.~      The purpose of this study is to determine the safety and metabolism of hyperpolarized~     pyruvate in humans, and how this can be used to increase the effectiveness of MR imaging with~     regards to patient care.~   "
178421|NCT01229605|"~     The standard therapy for patients who have locally advanced breast cancer is to receive~     chemotherapy before surgical removal of tumor. This is called neoadjuvant chemotherapy (NAC).~     Chemotherapy is used to shrink the tumor before surgery, which sometimes may allow for a~     smaller portion of the breast to be removed. Receiving chemotherapy before surgery may~     sometimes also allow for smaller portions of the breast to be removed. Getting chemotherapy~     prior to surgery may also control any hidden metastatic disease and thereby decrease the risk~     of cancer relapse. Pre-surgery chemotherapy is a standard management approach for locally~     advanced breast cancer.~      Different combinations of drugs can be used as part of the pre-surgery chemotherapy. The~     purpose of this study is to determine if using a chemotherapy regimen of TC is effective way~     to manage locally advanced breast cancer (Stage IIA- IIIB) when the TC is given before~     surgery. The investigators also hope this study will help us to better understand how the~     tumor tissue is affected by this combination of chemotherapy drugs.~      The TC drug combination is FDA approved for use in treating breast cancer, and it has been~     shown to be equally effective as other commonly used chemotherapy regimens when used after~     surgery; but, the TC drug combination has not yet been studied in conjunction with NAC for~     use before surgery. The investigators will be studying the combination of TC used before~     surgery as a means of possibly shrinking the tumor.~   "
178422|NCT01229592|"~     In recent years, several new methods for treatment of catheter-related bloodstream infections~     (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable~     success [1-10].~      Long-term tunnelled central venous catheters provide a reliable access for administration of~     chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of~     complications such as bacteremia. The need to preserve these intra-vascular devices as long~     as is possible in patients in whom conventional treatment was failed makes emerge antibiotic~     lock-technique.~      Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been~     published using the ethanol lock-therapy as a prophylactic therapy in catheter related~     infections, neither her application in short-term CVCs.~      Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of~     non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit~     (HPSICU).~      Methods: An academic, prospective, randomized and controlled clinical trial is proposed.~     Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock~     or control group with conventional measurements such as anticoagulants). In the follow-up~     period, we will register all necessary data to evaluate the end-points of study (CBRSI rate,~     catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to~     ethanol).~   "
178433|NCT01229449|"~     The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen~     plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg, acetaminophen compared with a~     combination of 400 mg ibuprofen plus 25.6 mg codeine (Nurofen Plus®) and a combination of~     1000 mg acetaminophen plus 30 mg codeine (Panadeine® Extra) in terms of total analgesic~     effect, peak analgesic effect, onset and duration of action and the subject's overall~     assessment of the study medication.~   "
178434|NCT01229436|"~     This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the~     affected fingers and the patient and physician reported treatment satisfaction and disease~     severity and their relation to ROM. Recovery to normal activities, recovery time (How long~     overall, time to use hand, time to return to work or daily activities, amount of work or~     daily activity time missed or reduced and affects on productivity and daily activities) will~     be assessed via patient diary. Use of concomitant analgesic medications will be recorded and~     total healthcare resource utilization (HCRU).~   "
178423|NCT01229579|"~     Pakistan is one of the 4 developing countries where cases of poliomyelitis are still being~     identified. Despite the incessant efforts by WHO and UNICEF, this disease is far from~     control. There is a need to develop new and innovative strategies to contain the disease and~     eradicate it from the countries where new cases continue to be identified.~      Zinc is an essential component of scores of enzymes in the human body. Recent reports have~     indicated that this trace element along with other micronutrients enhances the protective~     functions of immune cells. Moreover, zinc deficiency leads to dysregulation of balanced host~     responses to infection resulting into decreased antibody production and suppressed immunity.~     Zinc is also an essential cofactor for thymulin which is known to modulate cytokine release~     and induce immune cell proliferation. Zinc deficiency is also found to impair an individual's~     epithelial barrier function, which may further depress the vaccine entry into the mucosal~     cells.~      Role of zinc in the prevention of diarrheal diseases and other infections in children is well~     documented. However, there are very few reports about its contribution to enhanced immunity~     by supporting body's natural defense system.~      Zinc insufficiency is widespread in socioeconomically deprived children in South Asia and the~     recent most national nutrition survey (2003) . Moreover, diarrhea is also very common in~     infants in Pakistan. Such diarrheal episodes can limit entry of attenuated polio virus into~     the mucosal cells, thereby, leading to inadequate immune response. Association between recent~     diarrheal history and increased vaccine failure in infants has been shown in a study from~     Brazil. The recent Lancet Nutrition series has also recommended regular zinc supplementation~     to address child undernutrition and stunting and underscored the need to treat diarrheal~     episodes with zinc to expedite recovery. Other recent studies of zinc supplementation in low~     birth weight infants in South Asia have also shown significant improvement in diarrheal~     disease burden and mortality.~      On the basis of these lines of evidence, it is possible that some of the cases of vaccine~     failure in this region could be a consequence of compromised immunity and, hence, diminished~     response to OPV. This could potentially be reversed by addressing such gross undernutrition~     and micronutrient deficiencies. It can thus be hypothesized that zinc supplementation at~     community scale would enhance the immune response in infants to OPV.~      In order to test this research question, the investigators propose to undertake 12-month~     randomized controlled trial among a cohort of Pakistani infants of 0-14 days of age. Such a~     trial would enable us to understand the synergistic role of zinc (if any) with OPV in~     enhancing immune response against polio and sero-conversion rates.~   "
178424|NCT01229566|"~     The primary objective is to determine the efficacy of AKR963 compared to placebo and active~     comparator in lowering fasting triglyceride levels in patients with very high fasting~     triglyceride levels ≥ 500 and ≤ 1500 mg/dL.~   "
178425|NCT01229553|"~     The primary objective of this study is to measure efficacy of our new protocol by monitoring~     the results of our routine respiratory cultures at the end of the new standard treatment, and~     during routine visits for 1 year from initiation of therapy for Staphylococcus aureus. The~     secondary objective will include determining the clinical course (pulmonary exacerbations,~     antibiotic use, hospitalizations, pulmonary function tests) of patients who underwent the~     protocol.~   "
178426|NCT01229540|"~     Retinal neovascularization of diabetic retinopathy might be associated with genetic risk~     factors and environmental risk factors.~   "
178427|NCT01229527|"~     The purpose of this randomized double-blind trial is to define the correct dosage of~     Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to~     analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and~     Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and~     side effects.~      90 patients undergoing colonoscopy will be enrolled.~   "
178428|NCT01229514|"~     General anesthetic medications have been shown to cause neuronal cell death in the brains of~     infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and~     appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI~     (fMRI) is a technique developed for mapping brain activation and has been utilized to examine~     how the brains of children with a history of early exposure to ethanol function differently~     from children without such a history. This study will utilize fMRI to look for specific~     changes in brain activation patterns in children with a history of early exposure to general~     anesthesia, as compared to children without such exposure.~   "
178429|NCT01229501|"~     Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to~     be a key process in the development of cardiovascular disease. Endothelial dysfunction~     appears to be caused by both sleep disordered breathing and obesity. As endothelial~     dysfunction is among the first clinical marker that predicts future cardiovascular events,~     understanding molecular mechanisms leading to impairment of endothelial function is very~     important. Endothelial function requires the proper functioning of endothelial nitric oxide~     synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in the~     formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate optimal~     nitric oxide synthesis in endothelial cells as caveolin-1 helps to spatially organize eNOS in~     close proximity to signaling proteins that are important for eNOS activation. In certain~     diseases however, the balance of caveolin-1 and eNOS can be disrupted resulting in impaired~     nitric oxide synthesis and leading to endothelial dysfunction.~      The investigators therefore seek to characterize levels of caveolin-1, and correlate this~     with the presence or absence of sleep disordered breathing, obesity, and cardiovascular~     disease. The current IRB protocol covers the performance of fat biopsies on subjects who have~     recently completed a sleep study either in the Center for Sleep Medicine or in our sleep~     laboratory and were found to have sleep disordered breathing or no sleep disordered~     breathing, subject with sleep disordered breathing who have been treated successfully with~     continuous positive airway pressure for 3-6 months, and subjects undergoing other studies in~     our lab who are obese or non-obese and subjects who have known cardiovascular disease and~     subjects without known cardiovascular disease.~   "
178430|NCT01229488|"~     The purpose of this study is to demonstrate the ability of the OcuMetrics system to measure~     oxygen on the surface of the eye. Oxygen is important to the health of the cornea. The~     proposed instrument will take advantage of phosphorescent dyes that are sensitive to oxygen~     concentrations to monitor oxygen concentrations on the surface of the eye. This will have~     obvious applications in eye research and contact lens testing.~   "
178431|NCT01229475|"~     Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure.~     Even in experienced centres, repeat interventions are necessary in up to 70 of patients to~     achieve sinus rhythm at a long-term follow-up.~      While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the~     ablation of paroxysmal and persistent AF ablation, different additional ablation strategies~     are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear~     lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms~     (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the~     presenting arrhythmia during procedure.~      The aim of the study is to determine whether there is a difference in terms of freedom from~     arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient~     with recurrence of persistent atrial fibrillation.~   "
178438|NCT01229384|"~     Hypothesis: That administration of nebulized therapy for bronchiolitis when using positive~     airway pressure is superior to standard mask ventilation in reducing hospital admissions.~      Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by a variety of~     different viruses. It is the most common LRTI in children under 24 months old. Multiple~     studies have documented variation in treatment, hospitalization rates, and length of hospital~     stay for bronchiolitis, suggesting a lack of consensus and an opportunity to improve care for~     this common disorder.~      Research to determine optimal delivery methods of respiratory medications that may augment~     oxygenation by decreasing atelectasis (Lung cell collapse) and increasing oxygen saturation~     have not been done. Currently bronchodilators are delivered through a passive process,~     inhaled as they are nebulized (made from liquid into gas) into a face mask. This study will~     evaluate whether using a newly developed positive pressure nebulization device that uses~     pressure to expand lung cells and, hypothetically, deliver the medication better, improves~     oxygenation by reducing atelectasis (lung cell collapse) to decrease hospitalization in~     infants with moderate to severe bronchiolitis.~      Positive pressure nebulization is a relatively new adaptation of a previously existing~     modality, and is already currently in use here at PCH.~   "
178439|NCT01229371|"~     The purpose of this study is to assess the humoral immune response and safety of the~     parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V~     using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly~     adults, using the EMA (European Medicines Agency) regulation as a guideline.~   "
178440|NCT01229358|"~     This prospective, multi-institutional randomized clinical trial of a silver ion eluting~     dressing material compared to standard dry gauze for closed skin incisions after open~     surgical revascularizations for peripheral vascular occlusive disease. Based on the ability~     of the silver to lower the bacterial contamination of these vulnerable surgical skin~     incisions, the investigators hypothesize that immediate application of Acticoat Absorbent® as~     a post-operative dressing will reduce closed incisional wound complications in patients~     undergoing lower extremity revascularizations involving infrainguinal skin incisions compared~     to standard non-silver eluting dressing material.~   "
178441|NCT01229345|"~     The purpose of this study is to assess the effect of eating breakfast in combination with~     exercise on fat usage, appetite and brain performance later in the day.~   "
178442|NCT01229332|"~     A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage~     forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the~     potential clinical effect of ND0611 will be explored in subjects with PD and motor~     fluctuations.~   "
178443|NCT01229319|"~     Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet~     radiation exposure. While most authorities consider AK as a pre-malignant lesion, some~     consider it as an incipient squamous cell carcinoma (SCC). In addition, the skin around~     clinically obvious AK lesions has been subject to the same chronic ultraviolet exposure,~     resulting in genetic damage and mutations, resulting in field cancerization. Subclinical~     AKs may progress to clinical AKs, or even de novo invasive SCCs.~      Among the current therapies for the treatment of AK are excisional surgery, cryosurgery,~     electrodessication and curettage, topical chemotherapy and light therapies. With cryotherapy,~     treated lesion clearance rates at 3 months post-treatment after double-freeze thaw~     cryotherapy has been reported to be around 76-88%; Overall lesion clearance rate at~     approximately 5 months post-cryosurgery has been reported to be 35-51%.~      Imiquimod is a topical immune response modifier and a 5% formulation has been approved for~     the treatment of AKs in the US as a 2x/week for 16 week regimen and in Europe as a 3x/week~     for 4 week regimen for 1 or 2 courses of therapy. Topical imiquimod treatment may also reduce~     subclinical lesions in the treatment area, resulting in fewer new AK lesions developing~     over the same period of time when compared to focal treatment. In a comparison of cryosurgery~     versus imiquimod for the treatment of AKs, Krawtchenko et al reported initial complete~     clearance rates of 68 and 85% by clinical assessment, respectively. However, the treatment~     field sustained clearance rate was 4% versus 73%, respectively. Tan et al reported that while~     application of imiquimod or vehicle following cryosurgery resulted in comparable target AK~     clearance rates at 12 weeks of 79% versus 76%, respectively, the imiquimod group had fewer~     total AKs and fewer subclinical AKs.~      Imiquimod cream at a concentration of 3.75% has been found in Phase 3 studies to be superior~     to placebo cream with respect to clearance of AKs using a regimen of up to 2 packets (250 mg~     of cream per packet, 500 mg total) applied daily to the entire face (approximately 200 cm2)~     for two 2-week treatment cycles separated by a 2-week no-treatment period. This study aims to~     examine the benefit of cryotherapy in combination with imiquimod 3.75% compared to~     cryotherapy alone.~   "
178444|NCT01229306|"~     Catheter ablation with isolation of the pulmonary veins has proven to be an effective~     treatment option in patients with paroxysmal atrial fibrillation. In patients who have a~     relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators~     compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial~     line.~   "
178445|NCT01229293|"~     This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of~     Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical~     Institute, University of Southern Denmark~      Aim: To evaluate the effect of implant design on postoperative total leg muscle function~     recovery and gait in hip replacement patients.~      Design: A prospective randomized controlled clinical trial where patients are randomized into~     (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery~     (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks~     post-surgery.~   "
178446|NCT01229280|"~     The proposed study was designed as a randomized two-sequence, two period crossover trial to~     assess the bioequivalence, pharmacokinetic profiling and safety of a brand generic~     formulation of darifenacin [Darisec(R) 7.5 mg] vs. the innovator [Enablex(R)7.5 mg]in healthy~     volunteers in postprandial state.~   "
178447|NCT01229267|"~     This is a study to determine whether investigational V212 reduces the incidence of herpes~     zoster (HZ) compared to placebo when administered to recipients of autologous hematopoietic~     cell transplants (HCT).~   "
178448|NCT01229254|"~     The primary purpose of this study is to optimize drug exposure in the target population.~   "
178449|NCT01229241|"~     The aim of the study is the assessment of the systemic absorption of local anesthetics during~     continuous epidural infusion for postoperative pain control.~   "
178450|NCT01229228|"~     The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe~     and effective for the treatment of dental pain.~   "
178451|NCT01229215|"~     This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled~     study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections~     administered monthly or every other month in patients with geographic atrophy.~   "
178664|NCT01226433|"~     This observational study will assess a model for providing family planning through quarterly~     events organized by dairy cooperatives supported by Land O'Lakes in Kenya.~   "
178452|NCT01229202|"~     Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound~     healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the~     treatment of eye diseases associated with neovascularization. The purpose of this randomized~     study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on~     the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and~     assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery,~     where a small drainage canal is created at the front of the eye, is the most common glaucoma~     surgery performed worldwide. The goal of the surgery is to control intraocular pressure.~     Failure of this procedure is most commonly caused by excessive scarring of the surgical site.~     If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of~     surgery, wound healing may be slowed and surgical failure prevented.~      The results of this study will be helpful in the future development of new more effective and~     safe surgical techniques for treatment of glaucoma.~      Patients who have given informed consent are randomized into two groups. One group receives~     standard of care for trabeculectomy surgery and the other group receives standard of care~     plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection~     of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are~     seen by their study doctor six times in the following year. At these visits measurements are~     taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical~     exam and at months six and twelve photographs of the patients' eye are taken.~   "
178453|NCT01229189|"~     Vitamin D deficiency is wide spread in South Asian population and is contributing to burden~     of disease in this region including Pakistan. The relative importance of vitamin D~     deficiency, mutation in its receptor and maternal and child health has not been established~     in Pakistan and population based studies are required to explore and avert the maternal and~     Neonatal complications and consequences of Vitamin D deficiency~      The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and~     their Infants. It will be a double blind placebo controlled trial, which will be conducted in~     a rural district of Pakistan.~   "
178454|NCT01229176|"~     This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the~     Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is~     highly endemic and an efficacious vaccine against this disease is very much needed.~   "
178455|NCT01229163|"~     Background:~      - Treatment outcomes for substance abuse are improved by regular attendance at counseling~     sessions, and attending at counseling sessions can be futher improved by prize-based~     incentives. However, a system of prize-based incentives can be difficult to administer~     without computerization for accurate recordkeeping and rapid calculation of earnings. NIDA~     researchers have developed the eXtensible Platform for Motivational Incentives (XPMI), a~     computer program that for reinforcement of weekly counseling attendance. Users are eligible~     to win prizes through automated draws. The researchers are interested in testing the~     effectiveness and ease of use of the XPMI software so it can ultimately be run by staff in~     community treatment programs.~      Objectives:~        -  To test the XPMI program in a clinic setting, with emphasis on its functionality,~          usability, and acceptability for counselors.~        -  To test and validate XPMI s accuracy in calculating incentives to reinforce drug~          abstinence.~      Eligibility:~      - Individuals at least 18 years of age who are participating in clinical trials for treatment~     of heroin dependence in an outpatient treatment-research program, and have at least 14 weeks~     remaining in the program.~      Design:~        -  Participants will meet with their counselors as regularly scheduled. Twelve of the~          visits will count toward this study, with 2 extra weeks in case of counselor absence or~          clinic closure.~        -  Participants will receive an incentive in the form of a prize draw for arriving to~          counseling appointments on time, on the scheduled day. (Participants may reschedule one~          appointment per week without losing the chance for a prize draw.) For each consecutive~          appointment attended on time, participants will receive extra prize draws; attending~          three counseling appointments in a row can earn four bonus prize draws.~        -  To draw for prizes, participants will push a button on a computer. Each prize draw could~          result in a small prize worth $1 to $2, a large prize worth $20, a jumbo prize worth~          $100, or no prize at all. The average prize total per person is expected to be about~          $378.~        -  Participants will also be asked to fill out questionnaires about the computer program.~   "
178456|NCT01229150|"~     Background:~      AZD6244 (ARRY-142886) is an investigational anticancer drug that is designed to block a~     critical component (MEK (methyl ethyl ketone)) of a pathway (MAP (mitogen-activated protein)~     kinase pathway) that causes some lung cancer cells to grow. The MAP kinase pathway could be~     overactive in a proportion of lung cancers, including some which also have another mutation~     in a protein known as KRAS (Kirsten rat sarcoma viral oncogene homolog). Approximately 20% of~     lung cancers have KRAS mutations which can make some cancer treatments including erlotinib, a~     standard anticancer treatment drug less effective. Researchers are interested in determining~     whether AZD6244 is effective in treating advanced NSCLC (non small cell lung cancer),~     including KRAS mutated lung cancer that has not responded to standard therapy.~      Objectives:~      To determine the effectiveness of AZD6244, either alone or in combination with erlotinib, in~     preventing tumor growth in individuals with NSCLC.~      Eligibility:~      Individuals at least 18 years of age who have been diagnosed with advanced NSCLC that has not~     responded to standard therapy.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood tests,~          imaging studies, and potentially, tumor biopsy tests to determine whether a~          participant's NSCLC contains mutations in the KRAS protein.~        -  Participants will be divided into two groups based on the status of the KRAS protein in~          their NSCLC tumor cells:~        -  Individuals with normal KRAS protein: Half will receive AZD6244 and erlotinib, and half~          will receive only erlotinib.~        -  Individuals with mutated KRAS protein: Half will receive AZD6244 and erlotinib, and half~          will receive only AZD6244.~        -  Participants will take their assigned medications daily (on an empty stomach in the~          morning and/or evening, depending on the treatment) for 28-day cycles of treatment.~          Participants will also keep a medication diary to record any side effects.~        -  Participants will have frequent blood tests during the first cycle of treatment, and~          will have imaging studies or other tests as required by the study researchers.~          Participants may also have an additional tumor biopsy after the end of the first~          treatment cycle.~        -  Treatment will continue until the disease progresses, significant side effects develop,~          the participant chooses to leave the study, or the researchers end the study....~   "
178457|NCT01229137|"~     Assessment of sensor parameter in patients with heart failure.~   "
178458|NCT01229124|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in RNA and identify biomarkers related to cancer.~      PURPOSE: This research study is studying RNA biomarkers in tissue samples from infants with~     acute myeloid leukemia.~   "
178459|NCT01229111|"~     This phase II trial is studying how well giving cediranib maleate together with combination~     chemotherapy works in treating patients with advanced biliary cancers. Cediranib maleate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by~     blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, leucovorin~     calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving cediranib maleate together~     with combination chemotherapy may kill more tumor cells.~   "
178460|NCT01229098|"~     The purpose of this study is to evaluate the effect of once daily use of LEO 80185 gel on the~     hypothalamic-pituitary-adrenal (HPA) axis and calcium metabolism in subjects with extensive~     psoriasis vulgaris.~   "
178461|NCT01229085|"~     To evaluate the efficacy of the combination of mometasone furoate 0.1% and Salicylic Acid 5%~     in patients of both sexes who presented clinical symptoms of psoriasis of mild to moderate.~   "
178698|NCT01225991|"~     The purpose of this study is to examine the effects of milnacipran for the treatment of pain~     in rheumatoid arthritis in older adults.~   "
178462|NCT01229072|"~     The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an~     endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its~     destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade,~     especially the anti-activated factor X. The end result of these actions is the inhibition of~     biochemical training and synthesis of certain clotting factors that activators of critical~     functions in the genesis of a blood clot. Patients with chronic renal failure (CRF) who use~     the treatment of hemodialysis need a system of anticoagulation with the direct thrombin~     inhibitor and / or heparinóides to prevent thrombosis.~      Based on clinical studies, to control the level of plasma heparin in patients with CRF is~     essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa~     should be used as a substrate of protection for those patients on hemodialysis.~   "
178463|NCT01229059|"~     This study aims to explore time-dependent effects of lipid infusion an intramyocellular lipid~     metabolites and the induction of impaired insulin signaling.~   "
178464|NCT01229046|"~     This study will evaluate the safety, tolerability and PK of ticarcillin-clavulanate in~     infants <91 days of age with suspected systemic infection.~   "
178465|NCT01229033|"~     Catheter ablation has proven to be an effective treatment option in patients suffering from~     symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major~     steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2)~     modification of left atrial and eventually right atrial substrate by ablation of complex~     fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary~     veins, around the left atrial appendage, at the mitral annulus and the septum.~      When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial~     tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the~     significance of the AT is unclear.~      In the following study we examine the hypothesis that an ablation of AT occuring during CFAE~     ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF~     or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).~   "
178466|NCT01229020|"~     Assessment of regional contribution of different areas of the lung to its integrated function~     is often required, such as prior to lung resection in the presence of tumor or emphysema.~     This assessment is derived from the proportion of zonal radionuclear perfusion or~     ventilation. The investigators hypothesized that lung VRI may provide an alternative approach~     to assess regional lung function.~   "
178467|NCT01229007|"~     The objective of this study is to assess the efficacy and safety of a Von Willebrand~     Factor/Factor VIII (VWF/FVIII), Biostate, and to investigate the pharmacokinetics of Biostate~     in children with haemophilia A.~   "
178468|NCT01228994|"~     The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers,~     baclofen will be superior to placebo for smoking abstinence measures.~      The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher~     rates of medication compliance (i.e. take the medication as directed for the trial period)~     than those in the placebo group.~      The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco~     withdrawal and craving ratings as compared to placebo.~   "
178469|NCT01228981|"~     The purpose of this study is to characterize type 2 diabetic patients with initial~     alterations of diabetic retinopathy (DR) based on 3 different phenotypes previously~     identified and different patterns of progression in order to correlate this data with genetic~     information.~   "
178470|NCT01228968|"~     Subjects will undergo a brief magnetic resonance (MRI) scan. The resulting images will be~     used to compare two abdominal fat segmentation techniques. The first technique is already~     validated and in use. The second technique was recently developed and has not been validated.~     The hypothesis is that the second technique will be the faster and more reliable of the two.~   "
178471|NCT01228955|"~     Impaired health related quality of life (HRQOL) including fatigue, problems with sleep and~     psychosocial well being (physical, emotional, and spiritual) have been noted in adult cancer~     survivors. Physical domain is one of the most common measured indicators of HRQOL. Despite~     the tremendous implications of having an impaired QOL, few studies have staged interventions~     aimed at improving HRQOL in a heterogeneous group of cancer survivors. There is little~     literature examining whether a yoga intervention is feasible in a heterogeneous group of~     cancer survivors.~      The proposed research will utilize Vanderbilt Ingram Cancer Center (VICC), Nashville General~     Hospital (NGH) and REACH for Survivorship program for a pilot study. The investigators will~     see if a study using a broad range of diagnoses is feasible for a Yoga Intervention.~   "
178472|NCT01228942|"~     The purpose of this study is to determine if the COXEN algorithm, using the diagnostic device~     Affymetrix GeneChip, is able to predict which chemotherapies will be best for treatment of~     recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.~   "
178473|NCT01228929|"~     Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and~     after an intervention (such as a dry eye treatment, environmental change, artificial tear~     use, or contact lens wear) in a controlled-environmental chamber, over time using non-contact~     instruments.~   "
178474|NCT01228916|"~     Tobacco use and tobacco-caused illnesses and death are increasing in developing countries~     globally, so it is critical to study these countries in order to effectively address the~     tobacco epidemic. The proposed project will test the effectiveness of community-based~     interventions for secondhand smoke and quitting smoking in eight underserved communities in~     the Dominican Republic. The project will also partner with communities and national and~     international groups to determine whether the methods and interventions from this study in~     the Dominican Republic can also be used to help other countries in the region and underserved~     groups in the United States.~   "
178475|NCT01228903|"~     This study will test the hypothesis that uric acid impairs the function of vessels in~     patients with kidney disease~   "
178518|NCT01228344|"~     The purpose of this study is to describe the pediatric and adult patients (U.S. and foreign~     residents) diagnosed with malaria and treated with artemether-lumefantrine with regard to~     their demographics, including evaluation of their malaria immune status, treatment~     effectiveness, prior and concomitant medication use, and the occurrence of adverse events in~     association with artemether-lumefantrine treatment, based on the information collected in the~     CDC Malaria Case Surveillance Report Form.~   "
178476|NCT01228890|"~     In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the~     CATCH-IT primary care/Internet based depression prevention intervention against Attention~     Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an~     intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk~     adolescents based on elevated scores on the PHQ-A, a screening measure of depressive~     symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into~     either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months~     post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders,~     and on measures of role impairment in education, quality of life, attainment of educational~     milestones, and family functioning; and (d) conduct exploratory analyses to examine the~     effectiveness of this intervention program, moderators of protection, and potential ethnic~     and cultural differences in intervention response.~   "
178477|NCT01228877|"~     Performing adduction and abduction resistance exercise will increase hip bone density and~     strength to a greater extent than doing squat and deadlift exercise.~      Aim #1: To determine if doing hip adduction and abduction resistance exercise training for 16~     weeks improves spine bone mineral density and hip bone mineral density and strength as~     determined by finite element modeling.~      Aim #2: To compare the effects of hip adduction and abduction exercise to squat and deadlift~     exercise with respect to potential changes in hip bone mineral density and strength.~      Aim #3: To determine if the addition of adduction and abduction exercise to squat and~     deadlift exercise promotes an additive effect with respect to changes in spine bone mineral~     density and hip bone mineral density and bone strength.~   "
178478|NCT01228864|"~     The Brody belt may help improve quality of life in patients using urinary drainage bags.~     PURPOSE: This clinical trial studies the Brody belt in improving the quality of life in~     patients using urinary drainage bags.~   "
178479|NCT01228851|"~     The purpose of this study is to assess the facilitation of balance in Parkinson's disease~     (PD) patients using the Nintendo Wii fit, with the ultimate goal of developing a program for~     function and fitness in this patient population. In this study, PD patients will participate~     in group exercise classes using the Wii Fit and the effects on balance, postural sway, and~     quality of life assessed.~   "
178480|NCT01228838|"~     The purpose of this study is to assess the efficacy, safety and tolerability of NGX-1998~     applied for 5 minutes for the treatment of postherpetic neuralgia (PHN).~   "
178481|NCT01228825|"~     Infection, especially mediastinitis, is major complication in cardiac surgery. Considering~     that cardiopulmonary bypass (CPB) can alter kinetics of drugs, including antibiotics, the aim~     of this study was to evaluate the influence of cardiopulmonary bypass ( CPB) on plasma~     concentrations and pharmacokinetics of cefuroxime, administered prophylactically, in a 1.5g~     dose, followed by three bolus of 750mg every 6 hours, for 24 hours, in 19 patients undergoing~     coronary artery bypass graft (CABG) with CPB (CPB Group, n = 10), or without CPB (Off-Pump~     Group, n = 9); and assess whether the proposed dosing regimen is adequate to maintain plasma~     concentrations above 16 g/L (4 times the MIC) for the first 24 hours after the beginning of~     surgery.~   "
178482|NCT01228812|"~     The purpose of the study is to compare physical activity behaviour of rheumatoid arthritis~     patients with healthy matched controls.~   "
178483|NCT01228799|"~     Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one~     operation is superior to the other. Both procedures are performed in patients with medically~     uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure,~     which showed encouraging results without antimetabolite usage intra- and postoperatively.~     Purpose of the study is to compare both surgeries concerning success rate, intraocular~     pressure, medication and complications. So far there is no comparison of the standard~     procedure trabeculectomy and the new approach, canaloplasty available.~   "
178484|NCT01228786|"~     The present study is designed to examine the expression of VDR, CaSR, PTH, Cyclin D1, Ki67~     and PCNA and to find out its relationship with clinical parameters in parathyroid adenomas.~     Examination of the contribution of genes expression can elucidate the critical link between~     proliferation and functional abnormalities in parathyroid adenomas. Alternative to DNA and~     RNA, protein expression can provide a better understanding of this disease.~   "
178485|NCT01228773|"~     The objective of this study is~        1. to develop a web-based, tailored program for Cancer-related fatigue in cancer survivors,~          which is comprehensive and evidence-based,~        2. to evaluate the efficacy for cancer-related fatigue as a result of participating in the~          Web based, tailored program(Health Navigation®) for 12 weeks~        3. to evaluate the efficacy for quality of life, fatigue-related behavior, satisfaction~          with the treatment as a result of participating in the Web based, tailored~          program(health navigation®) for 12 weeks~        4. to assess the efficacy of such intervention compared with usual care in cancer survivors~   "
178486|NCT01228760|"~     The purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD)~     and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate~     cancer (CRPC).~   "
178487|NCT01228747|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients~     aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with~     1 or 2 anti-epileptic drugs.~   "
178488|NCT01228734|"~     The purpose of this study is to assess whether the progression free survival (PFS) time with~     FOLFOX-4 plus cetuximab is longer than that with FOLFOX-4 alone as first-line treatment for~     mCRC in Chinese subjects with RAS wild-type tumors.~   "
178489|NCT01228721|"~     PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the~     reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma~     patients and healthy control subjects using Spectralis® SD-OCT.~      METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator~     within one session with a brief rest between measurements. Three measurements were taken with~     the eye-tracker and retest function, and three were taken without this function, alternating~     between measurement methods.~        -  Trial with medical device~   "
178837|NCT01224145|"~     This study will assess pain intensity for the first 72 hrs after aggravated movement (cough)~     following Laparoscopic Inguinal or Umbilical Herniorrhaphy.~   "
178490|NCT01228708|"~     Aims:~      To design a proactive implementation strategy for a chronic-disease-management-programme.~      To describe effects of the active implementation of a programme for COPD-patients measured on~     patient-related goals and use of health resources.~      To describe stakeholders' evaluation of the implementation.~      Materials and method:~      An intervention study with 3000 COPD-patients cluster-randomized after a bloc-randomization~     of their GP-practice. 18 GP-practices in Ringkøbing-Skjern-Municipality are randomized to~     receive an active implementation or to an as usual group. A neighboring municipality acts~     as sleeping control. With data from registers and a questionnaire-survey the effect on~     COPD-patients self reported-health, evaluation of health system and changes in distribution~     of health resources is analyzed. How health professionals perceive the implementation and how~     it influences their conception, interactions and culture is illustrated by interviews with~     stakeholders.~      We expect to see improved health related quality of life, enhanced evaluation of the health~     system and a more appropriate distribution of health resources in the intervention group.~   "
178491|NCT01228695|"~     Weight gain is both a significant risk factor for obstructive sleep apnea and a side-effect~     of long-term systemic steroids therapy.~      This study aimed to investigate the impact of long-term systemic steroid treatment on sleep~     apnea.~   "
178492|NCT01228682|"~     A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns~     of Samsca in routine medical practice.~      A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca~     when used in a real-life setting.~   "
178493|NCT01228669|"~     This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate~     the safety, pharmacokinetics (how the trial drug is distributed in the body) and~     pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021~     administered intravenously and subcutaneously to healthy male subjects and subjects with~     haemophilia A or B~   "
178494|NCT01228656|"~     The aims is to evaluate the efficacy and comparative isolation of the association Mometasone~     furoate + Salicylic Acid and the substance isolated Mometasone furoate produced by the~     Laboratory Glenmark Pharmaceuticals Ltd. in patients of both sexes, patients with plaque~     psoriasis grade mild to moderate.~   "
178495|NCT01228643|"~     Prove the efficacy of pancreatic enzyme Norzyme ® imported by Pharmaceutical Chemistry~     Laboratory Bergamo Ltda. verified by activity lipase contained in the formulation in~     controlling steatorrhea in 16 patients of both sexes aged 14 to 65 years, patients with~     pancreatic insufficiency Exogenous any cause. It's effectiveness will be found in a study~     randomized, crossover, comparative biosimilar product produced by Creon ® Laboratory Solvay~     Farma Ltda.~   "
178496|NCT01228630|"~     The loratadine-pseudoephedrine combination has proven to be more effective than the use of~     these individual components. This prospective, randomized, double-blind and paralel study, in~     which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine~     association drug for treatment of signs and symptoms during 4 weeks.~   "
178497|NCT01228617|"~     This is an explorative study comparing new prototypes of Nicotine Replacement Products with~     Nicorette® gum.~   "
178498|NCT01228604|"~     This study is an open-label, 6 month trial, of immediate release methylphenidate (MPH-IR) for~     children with ADHD aimed at assessing whether the observable behavioral changes seen during~     treatment are associated with potentially more stable underlying modifications in brain~     functioning (resting-state functional connectivity). Additionally, we will also be looking at~     treatment effects on neuropsychological processes and reading skills. This information will~     contribute to the first Brazilian study assessing the cost-effectiveness of the treatment of~     ADHD. Children with ADHD will be compared to a sample of sex and age-matched sample of~     typically developing children.~   "
178499|NCT01228591|"~     The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses~     against ACUVUE® ADVANCE® lenses in the plus power parameters.~   "
178500|NCT01228578|"~     The investigators are conducting a double-blind, placebo controlled,randomized trial of~     multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in~     slowing disease progression, indicated by increased CD4 count, weight gain, and improved~     quality of life, and decreased morbidity, mortality, and drug-related adverse events (i.e.~     peripheral neuropathy, anemia, and diarrhea).~      The investigators hypothesize that daily multivitamin supplementation will: (1) improve~     immune reconstitution; (2) improve weight gain, and (3) improve quality of life.~   "
178501|NCT01228565|"~     The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC~     V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving~     radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.~   "
178502|NCT01228552|"~     The purpose of this study is to evaluate the efficacy and safety of intra-oral topical~     ketoprofen for the treatment of acute migraine.~   "
178503|NCT01228539|"~     The study will compare the efficacy of Trauma Affect Regulation: Guide for Education and~     Therapy (TARGET) vs. the best validated psychotherapy for adults with posttraumatic stress~     disorder (PTSD), Prolonged Exposure (PE). Male military personnel and veterans suffering with~     PTSD and problems with anger after returning from military service in Afghanistan (Operation~     Emerging Freedom, OEF) and/or Iraq (Operation Iraqi Freedom, OIF) will be participants. The~     goal is to determine if a present-centered psychotherapy that teaches skills for emotion~     regulation and does not require re-telling of traumatic memories is as efficacious as the~     trauma memory-focused PE psychotherapy.~   "
178504|NCT01228526|"~     To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without~     significantly compromised arterial circulation.~   "
178505|NCT01228513|"~     The purpose of this study is to evaluate the efficacy and safety of three concentrations of a~     development drug compared to placebo in the treatment of atopic dermatitis.~   "
178506|NCT01228500|"~     The primary aim of this study proposal is to test an innovative form of fetal bovine dermis~     bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound~     healing in diabetic foot ulcers.~   "
178701|NCT01225952|"~     The objective of this study is to compare the contrast sensitivity, high and low contrast~     visual acuity (VA), glare meter outcomes, and subject satisfaction with three different~     FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near~     vision following lens extraction in adults at least 40 years of age.~   "
178507|NCT01228487|"~     The important role of mechanical joint stress for the insert and progress of osteoarthritis~     (OA) is supported by recent studies. The degeneration of joint cartilage is caused either by~     unphysiological load of a healthy joint or physiological load of a damaged joint. The exact~     mechanisms leading from increased weight bearing and overuse to cartilage degeneration are~     mostly unknown.~      The hypothesis of the study is that parameters of oxidative stress in the joint synovial~     space reflect damages possibly leading to OA. These parameters correlate with parameters of~     oxidative stress in the peripheral blood. Aim of the study is the identification of such non-~     invasive obtainable biomarkers which represent the degenerative and regenerative changes in~     joint.~   "
178508|NCT01228474|"~     Experimental study to assess the efficacy of single embryo transfer (SET) with respect to~     double embryo transfer (DET) in an oocyte donation programme, 160 recipients will be~     randomized in two groups~   "
178509|NCT01228461|"~     Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly~     those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications such~     work has for effective interventions, little is known about the underlying pathophysiology of~     fatigue, association with medical co-morbidities and factors that may help predict those to~     be at highest risk.~      The proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship~     Program together with the investigators Hematologic Malignancies Program. In adolescent and~     young adults (AYA), ages 18 - 39 the investigators will address the following:~      Primary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on~     functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for~     fatigue~      Secondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine~     activity and fatigue Aim 2: Evaluate the association between fatigue and self reported~     fatigue in AYA Hodgkin lymphoma (HL) survivors.~      Hypotheses:~        1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to~          general population and will be associated with impaired functional outcome.~        2. Risk factors for fatigue include higher disease stage, B symptoms and elevated~          erythrocyte sedimentation rate at diagnosis, dose density of chemotherapy and higher~          doses and more expanded fields of radiotherapy.~        3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine~          complications.~        4. Levels of specified proinflammatory cytokines are associated with increased fatigue.~   "
178510|NCT01228448|"~     The investigational part of this study is using a mobile PET/CT scanner to take images of the~     participants tumor immediately after they are treated with proton radiation. This allows the~     participant to be treated and imaged on the same bed. The information obtained may improve~     the accuracy of treatment and may help to minimize the dose delivered unnecessarily to~     healthy tissue.~   "
178511|NCT01228435|"~     IPI-504 blocks a protein that is in cancer cells and is also in normal cells. This protein is~     called Heat Shock Protein-90 (Hsp90). Hsp90 helps protect certain other proteins from being~     destroyed by cells. These proteins can mutate to give off signals that allow cancer cells to~     keep growing. By blocking the function of Hsp90, we hope that the cancer cell will block the~     mutated protein and cause the cancer cells to die. This drug have been used in other research~     studies and in the laboratory and information from those other research studies suggests that~     thsi drug may help to treat lung cancer with ALK mutations. In this research study, we are~     looking to see what effects IPI-504 has in patients with lung cancer who have an ALK~     mutation.~   "
178512|NCT01228422|"~     The aim was to verify the Pharmacokinetics and Pharmacodynamics of alpha interferon~     product-2A - Blausiegel, taking as the comparator drug product Roferon ® A (interferon~     alpha-2A - Roche Laboratory).~   "
178513|NCT01228409|"~     Psoriasis is a chronic skin disorder with a prevalence of approximately 1-3% worldwide. At~     present, there is no curative therapy available and the clinical course is unpredictable, but~     in the majority of cases psoriasis is a chronically remitting and relapsing disease. Several~     clinical subtypes of psoriasis exist with differences in manifestations and skin areas~     involved.~      Chronic stable plaque psoriasis (Psoriasis Vulgaris) is the commonest form of the disease,~     accounting for 85-90% of cases. The circumscribed infiltrated skin lesions are scaly and~     erythematous and often symmetrically distributed over the body. Several types of palliative~     therapies exist. The therapies are either topical or systemic. The severity of chronic plaque~     psoriasis is often determined by the percentage of body surface area (BSA) involved. For~     mild, moderate and severe chronic plaque psoriasis with BSA involvement of up to 20%, initial~     therapy is topical. Phototherapy and numerous systemic therapies are usually indicated when~     more than 20% of skin is affected.~      Severe plaque-type psoriasis requires systemic and long-term therapy in order to induce and~     maintain remission. Acitretin 25mg/day combined with a phototherapy regimen is a standard~     treatment that provides clinically significant efficacy, however many patients experience~     tolerability issues due to retinoid-related adverse events. Retinoid-related adverse events~     include but are not limited to: alopecia, dry mucus membranes, pruritus, photosensitivity,~     elevation of liver enzymes, elevation of serum triglycerides, cholesterol and decrease of~     HDL, arthralgias, myalgias, eye irritation, blepharitis, photophobia, conjunctivitis,~     headaches, nausea, anemia and leukemia. Reducing the acitretin dose from 25mg/day to~     17.5mg/day may provide improved tolerability without compromising efficacy.~      The purpose of this study is to ascertain if reducing the acitretin dose from 25mg/day to~     17.5mg/day will provide improved tolerability without compromising efficacy.~   "
178514|NCT01228396|"~     Patients with marked bladder dysfunction as a result of secondary progressive multiple~     sclerosis are being recruited to receive AIMSPRO or placebo by subcutaneous injection, in~     this double-blind crossover study.~   "
178515|NCT01228383|"~     Study design:~      Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184~     + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs.~     placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center~     study~      Study objectives:~      Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.~      Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate~     the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To~     evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or~     placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo~     in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the~     monoclonal antibodies (mAbs).~   "
178516|NCT01228370|"~     Because the bladder neck and proximal urethra contain abundant α1-adrenergic receptors,~     α-blockers or α1-blockers are well-known to reduce bladder neck obstruction in patients with~     or without neurogenic bladder.~      α1-blockers seem to have a potential to reduce bladder outlet resistance during voiding in~     patients with neurogenic bladder.~      Based on these turnouts, we designed this clinical study to evaluate the clinical effect and~     safety of silodosin on voiding dysfunction associated with neurogenic bladder.~   "
178702|NCT01225939|"~     A study conducted over 3 periods to look at the drug in the body.~   "
178519|NCT01228331|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than once~     drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses~     high-energy x-rays to kill cancer cells. It is not yet known whether giving clofarabine or~     high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin~     hydrochloride or doxorubicin hydrochloride is more effective in treating young patients with~     acute lymphoblastic leukemia.~      PURPOSE: This randomized phase II/III trial is studying the side effects of giving~     clofarabine compared with giving high-dose cytarabine, pegaspargase, and combination~     chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride and to see~     how well it works in treating young patients with T-cell acute lymphoblastic leukemia or~     precursor B-cell acute lymphoblastic leukemia.~   "
178520|NCT01228318|"~     With the increasing age of people living with HIV/AIDS, age-induced osteoporosis is likely to~     be compounded by HIV/AIDS and HAART-associated bone loss. Mechanistically, osteoclasts the~     cells responsible for bone resorption form under the influence of the key osteoclastogenic~     cytokine Receptor- Activator of NF-KB (RANKL). The osteoclastogenic and proresorptive~     activities of RANKL are moderated by its physiological decoy receptor osteoprotegerin (OPG).~     Imbalance in the ratio of RANKL to OPG alters osteoclastic bone resorption and lead to~     osteoporosis. Activated T- and B-cells are a major source of RANKL, while normal~     physiological B-cells are a major source of OPG. T-cells regulate the production of OPG by~     B-cells. Thus changes in the immune system induced by HIV/AIDS and/or by HAART could affect~     B-cell and T-cells RANKL and OPG production. Indeed, data from our group shows that in an~     animal model of HIV/AIDS, the HIV-1 Transgenic rat, the development of osteoporosis is~     recapitulated as observed in HIV-infected patients, and B-cell OPG and RANKL production are~     concurrently down regulated and upregulated respectively. Furthermore, preliminary data in~     HIV-infected subjects suggests dramatic acute upswing in bone resorption following HAART~     initiation that peaks at 12 weeks and then declines. Based on these findings, the~     investigators hypothesize HAART associated bone loss is driven by immune reconstitution.~     Because this effect of HAART is dramatic in magnitude but short in duration, the~     investigators propose to apply antiresorptive agent (zoledronic acid, reclast®) to~     specifically spare patients from this dramatic but acute bone damage.~   "
178521|NCT01228305|"~     The current proposal tests the central hypothesis that acetaminophen will attenuate the~     oxidative stress response associated with cardiopulmonary bypass (CPB)-induced hemolysis in~     children undergoing cardiac surgery.~   "
178522|NCT01228292|"~     The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis~     with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill~     Patients.~   "
178523|NCT01228279|"~     Hypothesis:~      Patients starting peritoneal dialysis with a glucose-based regimen have high sympathetic~     activity in response to an increase in leptin and insulin. Converting patients from a regimen~     of only glucose containing dialysate to a regimen with non-glucose-based solution,~     icodextrin, will reduce the insulin and leptin levels and will reverse dialysis-induced~     increases in sympathetic activity.~   "
178524|NCT01228266|"~     The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate~     the safety and tolerability of autologous mesenchymal stem cell transplantation in patients~     with active multiple sclerosis~   "
178525|NCT01228253|"~     This preliminary study will examine the differential effects of rTMS on the recall of~     extinction of conditioned fear in patients suffering from PTSD (post-traumatic stress~     disorder ) compared with subjects without PTSD but with high risk of relapse.~   "
178526|NCT01228240|"~     Background: Metformin is usually using for glycemic control in type 2 diabetes mellitus.~     Different pharmaceutical types of metformin are available. As a clinical trial, we compared~     the efficacy and complications of metformin produced by Pars Mino pharmaceutical company,~     Iran with Apotex pharmaceutical company, Canada, in type 2 diabetic patients.~      Method: 18 eligible women with type 2 diabetes were given metformin Pars Mino or Apotex~     (500 mg twice a day) each for 6 weeks period in a randomized, double blind, crossover study.~     After 2 weeks washout period another 6 weeks period with another Brand of metformin was~     prescribed. FBS, HbA1C, lipid profile (Cholesterol, TG, HDL, and LDL), weight, and BMI were~     assessed before and after each treatment phase. The results were compared with each other by~     paired sample T-test, Independent sample T-test.~   "
178527|NCT01228227|"~     An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after~     otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch~     occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after~     PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing~     obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent~     studies have suggested that pretreatment with Atorvastatin may be associated with a reduction~     in infarct size after elective PCI. (5-7 ). Actually the standard pretreatment in patients~     undergoing elective coronary-PCI and already treated with aspirin is clopidogrel loading dose~     administration before procedure.(8,9)The investigators compared a high (80mg) re-loading dose~     of Atorvastatin with a high loading dose of Rosuvastatin (40 mg) both administered within 24h~     before the procedure in reducing the rate of periprocedural MI. Therefore, the investigators~     will conduct a single center, prospective randomized study to assess whether a single, high~     (80mg) loading (within 24h)dose of Atorvastatin compared with a single loading dose of~     Rosuvastatin (20 mg) is effective in preventing elevation of biomarkers of MI after elective~     coronary stent implantation. We evaluate the incidence of MACCE(occurring of cardiac death,~     myocardial infarction (including periprocedural myonecrosis) and stroke at 30 days 6 and 12~     month follow-up.~   "
178542|NCT01228032|"~     There is an urgent need to develop practical, sustainable approaches to improving medical~     care for persons treated in community mental health settings. This study will test a novel~     approach for improving mental health consumers based on a partnership model between a~     Community Mental Health Center and a Community Health Center. When this study is completed,~     it will provide a model for a medical home for persons with severe mental illness that is~     clinically robust, and organizationally and financially sustainable~   "
178543|NCT01228019|"~     This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant~     (TREDAPTIVE) in usual practice in Korea according to the new product re-examination~     regulations of the Korean Food and Drug Administration.~   "
178528|NCT01228214|"~     Treatment of coronary artery disease is a major health care problem across the entire word,~     and the United States. Unfortunately, despite a number of medical advances, diagnostic~     procedure, or epidemiological studies, the treatment of these patients remain complex, and~     and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United~     States and Canada documented that drug treatment, coronary interventions or both were not~     effective solution in coronary artery diseases.~      A novel approach has recently been developed, based on the critical role of the potassium (K)~     content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin~     (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the~     organs as the heart, the hemoglobin release both Oxygen and K ions.~      This apparently simple mechanisms occurs in human blood in all individuals but could be~     altered in subjects with acquired or hereditable defect in red-blood-cell K content, as in~     hypertensives or CAD patients.~   "
178529|NCT01228201|"~     The purpose of this study is to examine the effect of two different physical exercise~     protocols on changes in coronary artery plaque composition and development of in-stent~     restenosis in patients treated with percutaneous coronary intervention with stent~     implantation. The investigators will compare aerobic interval training and moderate~     continuous training. Both exercise protocols have a duration of 12 weeks. The investigators~     hypothesize that aerobic interval training is superior to moderate continuous training~     regarding effects on the composition of coronary artery plaques and a reduction in the~     development of in-stent restenosis.~   "
178530|NCT01228188|"~     The purpose of this study is to evaluate the efficacy and safety of surgical treatment of~     FTMH using an inverted ILM repositioning to improve anatomical and functional outcomes in~     patients with a macular hole.~   "
178531|NCT01228175|"~     The study will evaluate the effectiveness of smoking cessation using Varenicline versus~     placebo. Effectiveness will be measured by the average number of cigarettes smoked per~     smoking day for up to 36 weeks.~   "
178532|NCT01228162|"~     The researchers want to investigate the effects of muscle relaxation with rocuronium bromide~     during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic~     consumption in patients with total hip prosthesis replacement (general vs. spinal~     anaesthesia).~   "
178533|NCT01228149|"~     The most common cause of post-trabeculectomy filtration failure is postoperative scarring.~     Long-term preoperative treatment with local antiglaucoma agents containing preservatives has~     an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons~     prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs,~     controlling IOP with oral acetazolamide, and treating the eye with local steroids.~      Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP~     preoperatively with the aim of avoiding postoperative excessive scarring and the known~     adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term~     outcomes.~      This study will investigate comparability (non-inferiority) of medical benefits of two~     different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing~     COSOPT-S® bid to oral acetazolamide plus dexamethasone.~   "
178534|NCT01228136|"~     The purpose of this study is to determine if the use of tranexamic acid prior~     adenotonsillectomy in children can reduce surgical and postoperative bleeding.~   "
178535|NCT01228123|"~     The mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite~     manifold improvements in ICU care. At present, it is not clear if the method chosen for renal~     replacement therapy, i.e. intermittent haemodialysis (IHD) or continuous haemofiltration~     (CVVH), might impact on the outcome of these patients. For this purpose, a prospective~     randomised clinical study of the effect of continuous versus intermittent renal replacement~     therapy on the mortality and outcome of acute renal failure will be performed.~   "
178536|NCT01228110|"~     Low dose hydrocortisone IV in patients with CAP fastens recovery of pneumonia and prevents~     the development of sepsis related complications with a significant reduction in duration of~     mechanical ventilation~   "
178537|NCT01228097|"~     This study will compare brain and hormone responses to food images (and food) in women who~     undergo: (1) gastric bypass surgery; (2) principally restrictive surgery (laparoscopic~     adjustable gastric banding or laparoscopic sleeve gastrectomy); or (3) no weight loss~     surgery, with the intent of remaining relatively weight stable (within 10-15 lb of your~     present weight). The investigators will use magnetic resonance imaging (MRI) to see how the~     brain responds to pictures of food and to consuming a liquid meal replacement. The~     investigators wish to determine whether the two surgeries have different effects on appetite,~     as observable in the brain, and whether the possible effects on appetite differ from those in~     participants who have a similar body weight but remain relatively weight stable. The~     investigators also will draw blood to determine how hunger and fullness hormones change~     after eating and to see if there are any differences among the three groups. The study is~     being sponsored by the National Institutes of Health (NIH).~   "
178538|NCT01228084|"~     This phase II trial studies how well sulforaphane works in treating patients with recurrent~     prostate cancer. Sulforaphane may prevent or slow the growth of certain cancers.~   "
178539|NCT01228071|"~     This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal~     testosterone range after initial testosterone gel 2% application, time to steady state after~     after initiation of testosterone gel 2%, and drying time after application of testosterone~     gel 2%.~   "
178540|NCT01228058|"~     The purpose of this study is to evaluate the clinical utility of thrombelastography (TEG) to~     predict and identify trauma patients at increased risk of receiving blood transfusion,~     develop multiple organ failure and mortality.~      TEG has been proposed as a superior tool to rapidly diagnose and help guide resuscitation~     with blood products and preclinical data suggest that TEG is both more sensitive and specific~     than PT or PTT for coagulation abnormalities. Based on the preclinical work led by Dr.~     Holcomb, our hypothesis is that the Rapid TEG will help to identify these coagulopathic~     patients earlier, allow for rapid MT protocol activation, and assist in developing data~     driven blood product transfusion guidelines.~   "
178541|NCT01228045|"~     The investigators hypothesis is that the combination of TS-ONE with cisplatin and trastuzumab~     is safe and as effective as combination treatment for HER2 positive gastric cancer.~   "
178545|NCT01227993|"~     Background:~        -  Central serous chorioretinopathy (CSC) is a disease in which fluid accumulates under the~          retina and can cause distorted vision. CSC often resolves on its own without treatment,~          but in chronic CSC the fluid persists and can lead to permanent visual loss. Chronic CSC~          may be partly caused by hormones called androgens.~        -  Finasteride is a drug that can modulate the effects of androgens; currently it is~          marketed as a treatment for male pattern baldness and benign prostate enlargement. The~          results of a previous brief study suggest that finasteride is safe and may help reduce~          the effects of chronic CSC. However, more long-term data are needed to evaluate whether~          finasteride is a safe and effective treatment for chronic CSC.~      Objectives:~      - To collect more data on the safety and effectiveness of finasteride as a treatment for~     chronic central serous chorioretinopathy.~      Eligibility:~      - Individuals who previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot~     Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous~     Chorioretinopathy, and demonstrated clinical improvement on finasteride treatment.~      Design:~        -  The study requires 11 visits to the NEI outpatient clinic over 5 years, with visits~          occurring every 6 months. Participants will be screened with a medical history, physical~          examination, eye examination, and blood and urine tests.~        -  At each visit, participants will receive a supply of finasteride pills to take every day~          and will need to bring any leftover finasteride pills to the following visit.~        -  Participants will have eye examinations to test vision, eye pressure, eye movements, and~          retinal thickness. Additional eye examinations will evaluate the retina's sensitivity to~          light and study the blood vessels and flow of blood in the eyes.~        -  Blood and urine samples will be taken throughout the study.~        -  After the end of the study, participants may be able to speak to their doctor about~          continuing finasteride treatments with a prescription.~   "
178546|NCT01227980|"~     Background:~      - Individuals who are dependent on alcohol often have feelings of anxiety, irritability,~     anger, and depression. These feelings, as well as stress, may contribute to the risk of~     relapse and continued drinking. Studies have shown that alcohol consumption increases the~     activity of certain molecules in the brain known as CRH1 receptors, which are key to~     producing the body s response to stress, and whose activation generates feelings of anxiety.~     Researchers are interested in learning whether the experimental drug pexacerfont, which~     blocks CRH1 receptors and has been studied in individuals with anxiety disorders and~     depression, can lessen anxiety and craving for alcohol as part of alcohol-dependence~     treatment.~      Objectives:~      - To determine the safety and effectiveness of pexacerfont as a treatment for anxiety-related~     alcohol craving.~      Eligibility:~      - Individuals between 21 and 65 years of age who are alcohol-dependent and have problems with~     anxiety.~      Design:~        -  This study requires an inpatient admission to the NIH Clinical Center for approximately~          1 month, with two additional study visits 1 week and 1 month after discharge from the~          hospital.~        -  Participants will be screened with a medical history, physical examination, and blood~          and urine tests.~        -  During the inpatient period, participants will have standard treatment for alcohol~          dependence, including support and interventions from institute staff to address~          cravings, anxiety, or other psychological problems. Participants will not receive formal~          psychological treatment or psychiatric medications for anxiety, but will receive~          training in relaxation techniques.~        -  Participants will be assigned to take either pexacerfont or placebo for 3 weeks. During~          this time, participants will have the following procedures:~        -  Frequent blood tests.~        -  Rating scales and questionnaires about alcohol cravings and anxiety.~        -  Dexamethasone suppression test with frequent blood draws to study hormone response to~          stress.~        -  Social stress test involving public speaking, followed by blood samples and~          questionnaires on alcohol craving.~        -  Cue Reactivity (CR) session to study cravings and responses to alcohol-based cues.~        -  Functional magnetic resonance imaging scan to evaluate brain activity while taking the~          medication or placebo.~        -  Participants will have two follow-up visits for additional blood tests and~          questionnaires about the effects of the treatment ^.~   "
178547|NCT01227967|"~     Seasonal influenza is responsible for many hospitalizations and deaths each year, despite~     effective antiviral treatments. Some individuals have medical conditions such as heart or~     lung diseases that make them particularly at risk of severe influenza infections that may~     result in hospitalization or death. Oseltamivir (Tamiflu) is used most often to treat flu,~     but there are still many hospitalizations, complications, and deaths even with treatment.~     This study evaluated the use of combination antivirals (amantadine, oseltamivir, and~     ribavirin) compared to oseltamivir alone in the treatment of influenza in an at-risk~     population.~   "
178548|NCT01227954|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.~      PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain~     radiation therapy works in treating patients with brain metastases.~   "
178549|NCT01227941|"~     This study will determine whether MK-4827 can be safely administered in combination with~     pegylated liposomal doxorubicin, and if so, will obtain an estimate of the benefit of the~     combination in patients with ovarian cancer as compared to historical data with single agent~     pegylated liposomal doxorubicin. The first part of the study (Part A) is designed to~     determine the maximum tolerated dose (MTD) and evaluate the safety of MK-4827, when~     administered in combination with pegylated liposomal doxorubicin. Part B is designed to~     assess preliminary clinical activity of MK-4827, when administered in combination with~     pegylated liposomal doxorubicin to participants with ovarian cancer. It is hypothesized that~     MK-4827 can be administered, in conjunction with pegylated liposomal doxorubicin, with~     acceptable tolerability and that MK-4827, administered in conjunction with pegylated~     liposomal doxorubicin, will demonstrate a tumor response rate equal or superior to that of~     historical data for pegylated liposomal doxorubicin alone.~   "
178550|NCT01227928|"~     This is a study to determine whether therapy with pazopanib is effective and safe in Asian~     women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has~     not progressed on first-line chemotherapy.~   "
178551|NCT01227915|"~     The primary objective of this study is to evaluate, through clinical parameters, the~     comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% -~     Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using~     the percentage of improvement (sustained response rate) at the end of treatment.~   "
178552|NCT01227902|"~     The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and~     health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the~     following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine,~     lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures~     (POS) using a flexible dosing regimen.~   "
178553|NCT01227889|"~     BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and~     tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced~     (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg~     of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until~     disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will~     be allowed to crossover to an optional extension arm of the study to receive GSK2118436.~   "
178554|NCT01227876|"~     Is the primary objective of this investigation to compare the clinical efficacy of the drug~     test - Ster ® (prednisolone 1% ophthalmic suspension - Union Chemicals) in the comparator -~     Fort ® Pred (prednisolone 1% ophthalmic suspension - Allergan) in the control of~     postoperative inflammation in cataract surgery by phacoemulsification through periodic~     measurement of efficiency scores (number of cells in the anterior chamber, the presence of~     fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds).~   "
178703|NCT01225926|"~     The purpose of this study was to evaluate and compare uncorrected distance visual acuity~     measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric~     Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.~   "
178555|NCT01227863|"~     The primary objective of this study is to evaluate, through clinical parameters, the~     effectiveness of your medicine topic Maxinom ® (dexamethasone, neomycin and polymyxin B -~     Union Chemicals), comparing it to the topical medication Maxitrol ® (dexamethasone, neomycin~     and polymyxin B - Alcon ) by the percentage of improvement (sustained response rate) at the~     end of treatment, among the products studied.~   "
178556|NCT01227850|"~     Background and study hypothesis:~      Refeeding syndrome is a dangerous condition which could arise if patients who have had little~     or no food for many days, are started on any form of feeding. The metabolic consequences of~     this condition could affect the heart, lungs and nervous system of the patient and cause~     serious imbalance in the level of salts in the body.~      The available guidelines for predicting that refeeding syndrome may occur are very subjective~     since they depend mainly on a history which is sometimes difficult to obtain from the~     patient.~      The main biochemical landmark that refeeding syndrome has occurred is a fall in the phosphate~     levels once feeding has been started. There are currently no biochemical markers that can~     identify patients at risk of developing refeeding syndrome.~      Leptin and IGF1 are hormones which have been observed to go down if someone has had little or~     no food for a while. The investigators therefore hypothesized that using a combination of~     leptin and IGF1 values in a 'Refeeding Index' would make the latter a useful biochemical~     marker to predict that refeeding may occur, hence take the precautionary measures to avoid~     its occurrence before starting feeding.~      Design: Thirty five consecutive patients referred for commencement of parenteral nutrition~     (PN) were included. Serum leptin and IGF1 were measured prior to starting PN. Electrolytes,~     liver and renal function tests were measured before and daily for one week after initiating~     PN. The primary outcome was a decrease in phosphate on day two or three after initiating PN.~     A 'Refeeding Index' (RI) was defined as leptin x IGF1 divided by 2800 to produce a ratio of~     1.0 in patients who are well nourished.~   "
178557|NCT01227837|"~     In this double blinded study patients with resynchronization pacemaker- AICD were assigned to~     Omega3 and placebo randomly, results indicated that Omega3 had no more effect than placebo in~     mortality, BNP level and 6 minutes walk test.~   "
178558|NCT01227824|"~     The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50~     mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested~     at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI~     therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult~     subjects.~   "
178559|NCT01227811|"~     The present study was designed to assess the bioequivalence and pharmacokinetic profiling of~     a brand generic formulation of darifenacin [Darisec(R)]vs. the innovator [Enablex(R)]in~     healthy volunteers after a high fat breakfast.~      The bioequivalence will be evaluated using:~        -  the Area Under the Curve (AUC) and,~        -  the peak plasma concentration (Cmax).~      Safety will be evaluated recording:~        -  vital signs~        -  adverse events,~        -  laboratory analysis.~        -  EKG and chest XRays.~      Bioequivalence will be claimed if the drugs comply with local regulatory requirement, eg.:~        -  mean AUCt/AUCr and 90% confidence interval within 0.80-1.25~        -  mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25.~   "
178560|NCT01227798|"~     A Pilot Study to Evaluate the Safety and Efficacy of interferon-Alfacon1 (INFERGEN) in the~     treatment of patients hospitalized with Influenza-like illness caused by a novel swine origin~     Influenza virus and other circulating Influenza Viruses.~      The use of Interferon-alfacon1 as a co-treatment along with the standard of care antiviral is~     hypothesized to be safe. Clinical improvement of patients is hypothesized to be quicker.~   "
178561|NCT01227785|"~     This study has 2 purposes:~      The first purpose of the study is to test a new family of Boston Scientific Implantable~     Cardioverter Defibrillators (ICDs) and cardiac resynchronization therapy ICDs (CRT-Ds)~     and show how well these new devices work in patients. This new family is called the INCEPTA~     ICD and the INCEPTA CRT-D.~      The second purpose of the study is to collect data from a feature that monitors breathing. It~     is called the Respiratory Rate Trend (RRT). These data will help to better understand how~     changes in breathing relate to changes in clinical conditions.~   "
178562|NCT01227772|"~     Active vaccination with tumor specific antigens and VEGFR1 HLA-A24 epitopes can improve~     survival of patients with advanced Gastric Cancer.~   "
178563|NCT01227759|"~     This IIa study with intraindividual comparison of treated versus untreated to assess the~     wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an~     abrasive wound healing model.~   "
178564|NCT01227746|"~     Imatinib is the current standard treatment for advanced GIST. Previous studies have shown~     that GIST genotype was associated with treatment outcomes with exon 11 having superior~     outcome compared with exon 9 or WT.10, 11 In patients with exon 9 kit mutation, the response~     rate was higher at when imatinib was given at 800mg daily compared with the standard dose of~     400mg daily. Although the data linking tyrosine kinase mutation status and imatinib response~     in metastatic GISTs is intriguing, more information is needed before mutation testing is~     adopted as part of the routine analysis of high-risk or overtly malignant KIT-expressing~     GISTs.25 Despite the fact that exon 9 mutations are associated with a lower response rate,~     overall survival does not appear to be better with high-dose therapy. The investigators~     propose to conduct a retrospective analysis of mutational analysis on patients with GIST and~     determine the relationship between patient response and imatinib dose.~   "
178565|NCT01227733|"~     Adequate quality and quantity of RNA may be extracted from paraffin-embedded tumor blocks for~     gene expression analysis. This has clinical relevance as gene expression signatures may then~     be profiled using archival tumor blocks, which are more readily available than frozen~     tissues.~   "
178566|NCT01227720|"~     Comparative pharmacokinetic study of new oral nicotine replacement therapy products.~   "
178567|NCT01227707|"~     This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus~     Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic~     region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer.~     Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2~     weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy.~     After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of~     the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.~   "
178568|NCT01227694|"~     This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15~     patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the~     study with the primary objective of assessing the feasibility and safety of the knee~     articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary~     objectives are to assess the efficacy by imaging procedures and clinical questionnaires.~      MSC obtained from each patient's bone marrow will be isolated and expanded Ex-Vivo under~     GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21~     days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC~     in the knee by articular injection, and followed up for 12 month. Articular cartilage changes~     will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will~     measure the pain by the visual analogue scale (VAS), the self-reported functional status by~     Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire~     (SF-36) at 3, 6 and 12 month.~      The working hypothesis proposes that the expected regenerative articular cartilage effect of~     the MSC will be produced to a measurable degree by imaging procedures and clinical~     questionnaires.~   "
178569|NCT01227681|"~     The purpose of this study is to evaluate the effectiveness of neuroprotection from~     granulocyte colony-stimulating factor on Parkinson disease~   "
178570|NCT01227668|"~     The purpose of this study is to determine whether pediatric participants with irritability~     associated with autistic disorder who have responded to aripiprazole treatment will~     experience a relapse significantly later when continuing therapy with aripiprazole than will~     participants who receive placebo~   "
178571|NCT01227655|"~     Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an~     estimated incidence of 4.5-16/100,000 persons/year.~      BIA 9-1067 is currently being developed by BIAL (Portela & Cª,S.A.) to be used in addition to~     L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising~     results have been obtained for BIA 9-1067 in previous studies.~   "
178572|NCT01227642|"~     In standard treatment, the seeds are placed throughout the prostate to treat the entire~     prostate. This is done because it was impossible to know where the cancer was located within~     the prostate. A new technique has been developed using the same ultrasound imaging that you~     probably had when you had your biopsy. Using this technique, areas likely to contain prostate~     cancer can be identified.In this early study of 15 subjects, we will test if this method to~     plan your prostate seed implant is safe and can be done as part of regular care. Areas~     identified as suspicious for cancer will be treated with higher doses of radiation while~     those areas not demonstrating cancer will be treated to the standard minimum dose. The higher~     dose areas will receive two times the minimum dose the prostate usually receives. Because~     this technique is not perfect, those areas not identified as cancerous should be treated in~     case there is a cancer area that the technique did not identify. Subjects enrolled in this~     study will then be followed with this ultrasound technique over the next two years to monitor~     the changes to the cancerous areas and will undergo a biopsy two years after the procedure.~     Subjects will, of course, be monitored to assess the success of the technique and its side~     effects.~   "
178573|NCT01227629|"~     The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or~     in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and~     other adverse events.~      A secondary objective of this trial is to evaluate the anticoagulant effect of different~     doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory~     marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate~     bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data.~   "
178574|NCT01227616|"~     The objectives of this study are to compare the efficacy and safety of repeat doses of~     intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with~     hemodialysis-dependent CKD.~   "
178575|NCT01227603|"~     Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence~     of a new fixed dose combination tablet of nifedipine GITS and candesartan with the~     corresponding loose combination and to compare it with the individual drugs~   "
178576|NCT01227590|"~     The study is being conducted to evaluate whether African potato, an herbal medicine, can be~     used together with anti-HIV medicines without affecting the amounts of the anti-HIV medicines~     in the blood. African potato is an African herbal medicine widely used in Africa,~     particularly sub-Saharan Africa. Although it has not been proven, it is believed to help~     boost the immune system. Similar studies have been done on herbal medicines especially those~     that are used in developing countries. In some cases, the herbal treatments can affect the~     blood levels of other medicines when the medicines are used together. This study will measure~     the effect of African potato on lopinavir/ritonavir (Kaletra®), a common anti-HIV medicine.~     Lopinavir/ritonavir is approved by the United States Food and Drug Administration (FDA). The~     information obtained from this study will tell us if African potato and anti-HIV treatments~     can be used together to treat HIV infected patients in Africa and other resource poor~     regions.~   "
178577|NCT01227577|"~     This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in~     adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic~     myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and~     deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate~     of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients.~   "
178578|NCT01227564|"~     This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and~     tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as~     measured by positron emission tomography (PET) scans.~   "
178579|NCT01227551|"~     The purpose of this study is to assess the clinical efficacy of Intratumoral (IT) CVA21 in~     terms of immune-related Progression-Free Survival (irPFS) at 6 months as monitored via~     immune-related Response Criteria [irRECIST 1.1] (revised Response Evaluation Criteria In~     Solid Tumors [RECIST] 1.1).~   "
178792|NCT01224743|"~     Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient~     supplementation that may offer cardioprotective effects. This study assessed the effects of~     encapsulated fruit and vegetable juice powder concentrates on endothelial function and~     cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover~     clinical trial with three treatment arms.~   "
178580|NCT01227538|"~     Type 1 diabetes is condition in which progressive autoimmune destruction of insulin-producing~     beta-cells leads to absolute insulin deficiency. At the time of clinical presentation, it is~     estimated that 50-80% of beta-cell function has been lost. Good glycaemic control from~     diagnosis has been shown to preserve beta-cell function. The recent identification of~     immuno-interventions able to reduce autoimmune destruction and preserve beta-cell function~     has lead to an increased urgency to develop such tools.~      With mixed-meal stimulated serum C-peptide being a gold standard, there are currently no~     tests that are suited for use in clinical practice to detect and monitor residual beta cell~     function. There is a therefore a need for a test that is sufficiently sensitive to assess~     beta cell function reserve in Type 1 diabetes for clinical practice purposes, which will be~     simple, reproducible and suitable for use even in the non-observed setting.~      Using mixed meal stimulation of plasma C-peptide (stable by-product in insulin secretion that~     reliably reflects insulin production) response as a reference, we propose to compare mixed~     meal stimulated urinary C-peptide as potential candidate for this application. This is a~     pilot investigation in which a sample of 30 participants will be recruited.~      It is anticipated that the current project will identify a simple method for analysing beta~     cell reserve in Type 1 diabetes. This will then be applied to screening clinic populations of~     recently diagnosed patients with type 1 diabetes. The aim will be to identify subjects who~     may be suitable for early intensified insulin regimes (e.g. insulin pump therapy) and novel~     immuno-intervention strategies designed to preserve residual beta cell function and improve~     long-term outcomes. Currently such immunointervention has been reserved for subjects within 3~     months of diagnosis only, excluding a significant number of subjects who may potentially~     benefit.~   "
178581|NCT01227525|"~     Behavioral and physiologic observations suggest that the injection of local anesthetic is~     among the most feared or anxiety producing procedures during dental intervention. Discomfort~     during the injection is currently reduced by pharmacologic or mechanical methods. No~     technique has proven to be effective for every patient. The VibraJect LLC (USA) was first~     introduced in 1995 and was developed under the hypothesis that a vibrating needle would~     stimulate large diameter nerve fibers and thereby close the gate to smaller nerves carrying~     the pain signal from the injection site. Studies on adult patients have been promising. The~     purpose of this study is to investigate the efficacy of the VibraJect dental syringe~     attachment in reducing injection discomfort and procedural anxiety in the pediatric dental~     population.~   "
178582|NCT01227512|"~     The purpose of this study is to determine if hospitalized patients with symptomatic~     hyponatremia treated with tolvaptan are in the hospital for less time than patients treated~     with fluid restriction. The study will also test if tolvaptan is better than fluid~     restriction in treating the symptoms of hyponatremia in hospitalized patients.~   "
178583|NCT01227499|"~     Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their~     clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold~     standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine uptake~     is limited for its availability in china and easily influenced by medicine or food contained~     iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of~     thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily~     varied by operator subjective judgement. This study is focus on the role of peak systolic~     velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods:~     Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two~     clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic~     velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level below~     the low value of normal range. Graves disease is defined as the typical symptoms of graves~     disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is defined as~     lack of typical symptoms of graves disease or decreased iodine uptake.We use receiver~     operator curve(ROC) to evaluate its diagnosis value~   "
178584|NCT01227486|"~     The purpose of this study is to determine whether verification of correct tube placement~     after endotracheal intubation in the obese patient can be conducted as fast with ultrasound~     as with the conventional method of combined auscultation and capnography.~      The investigators hypothesize that ultrasound is a faster method for verifying correct~     endotracheal tube placement in the obese patient than combined auscultation and capnography.~   "
178585|NCT01227473|"~     Pre-diabetes, characterized by glucose levels that are above normal but below the diagnostic~     criteria for diabetes, is an increasingly common condition, particularly among African~     Americans. Changes in physical activity, changes in diet, and levels of stress influence the~     course of the disease. Helping individuals to reduce stress and to increase healthy coping~     strategies may enhance conventional diabetes prevention efforts, especially among African~     Americans. Mindfulness training is a cost-effective intervention which may be effective in~     reducing stress and enhancing the ability to make behavioral changes. This exploratory pilot~     study will examine the potential efficacy of a diabetes prevention education program that~     includes training in mindfulness-based stress reduction (intervention group) for pre-diabetic~     African Americans, comparing it to a conventional diabetes prevention program (control group)~     in the ability to improve glucose metabolism as well as other relevant physiological and~     psychological secondary outcomes.~   "
178586|NCT01227460|"~     This is a multi-center, prospective, randomized, double-blind, parallel, placebo controlled~     clinical trial evaluating the efficacy of sitagliptin in suppressing glucagon release in~     subjects with type 1 diabetes over a 16 week treatment period. The hypothesis of this study~     is that sitagliptin (Januvia™) will decrease post-prandial glucagon release and may result in~     improved glucose control in adult patients with type 1 diabetes. There is only one small,~     pilot study of sitagliptin in patients with type 1 diabetes which significantly reduced total~     daily insulin dose and A1c values while improving mean blood glucose (MBG) and time spent in~     euglycemic range (1). In the pilot study, GLP-1 and glucagon levels were not assessed. The~     purpose of this trial is to determine if sitagliptin can suppress the paradoxical rise of~     glucagon, and thus can decrease A1c.~      This study will enroll a maximum of 140 patients (with an expected 10% dropout rate) with A1c~     values between 7.5-10% who will be randomized in a 1:1 fashion to either the study drug or~     placebo. 100 of these patients will wear a continuous glucose monitor. Subjects may be using~     insulin via continuous subcutaneous insulin infusion (CSII) or multiple daily injections~     (MDI). The clinic visits will be conducted at screening, -1 week, baseline/randomization, 4~     weeks, 12 weeks, and 16 weeks in addition to telephone visits (Appendix 1 and 2). At home,~     starting at week 0 (randomization/baseline), subjects will take 100 mg/day of sitagliptin or~     placebo and continue for the study duration. Laboratory analysis will be performed at various~     time points assessing glucagon, A1c, C-peptide, glucagon-like-peptide-1 (GLP-1),~     glucose-dependent insulinotropic peptide (GIP), and insulin levels.~   "
178587|NCT01227447|"~     The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the~     urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further~     characterise morphology and function of the suburothelial myofibroblast network in the human~     bladder outlet.~   "
178588|NCT01227434|"~     This study will determine the efficacy of the small molecule CDK4/6 inhibitor PD 0332991 (as~     measured by progression free survival at 6 months) in patients with recurrent glioblastoma~     multiforme or gliosarcoma who are Rb positive. A total of 30 patients will be treated; 15~     will undergo a planned surgical resection and receive drug for 7 days prior to surgery,~     followed by drug after recovery from surgery, and the other 15 patients will receive drug~     without a planned surgical procedure.~   "
178589|NCT01227421|"~     This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing~     regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated~     influenza in adults and adolescents. The investigators hypothesize that treatment with~     Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza~     infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will~     reduce the complications of influenza, severity of symptoms, time lost from work, time to~     return to normal daily activities.~   "
178590|NCT01227408|"~     The investigators propose to conduct a clinical trial of neoadjuvant treatment utilizing~     chemotherapy formulations with favorable toxicity profiles: weekly doxorubicin, PPX and~     capecitabine. It is expected this combination will at least maintain the efficacy of a~     traditional chemotherapy regimen but will be associated with less toxicity, particularly~     nausea, vomiting and alopecia. In order to accomplish this the investigators have designed a~     chemotherapy regimen whose components (or administration schedule) are associated with~     minimal or no alopecia and are also considered to have low emetogenic potential.~      In an attempt to improve the efficacy of the regimen the investigators plan to study an~     alternate schedule of cyclophosphamide and methotrexate administration (metronomic~     chemotherapy) which appears to inhibit angiogenesis and therefore enhance the activity of~     conventional cytotoxic chemotherapy administered concurrently.~      In this trial the investigators aim to determine the clinical and pathologic response rate of~     12 weeks of doxorubicin followed by 4 cycles of PPX and capecitabine. Metronomic chemotherapy~     with cyclophosphamide and methotrexate will be administered during the 24 weeks of~     chemotherapy.~   "
178591|NCT01227395|"~     The investigation will be conducted for the purpose of determining the condition of~     occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet,~     verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug~     interactions and determining the factors affecting safety and efficacy.~   "
178592|NCT01227382|"~     The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis~     when compared to standard biopsy techniques.~   "
178593|NCT01227369|"~     Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate~     treatment~   "
178594|NCT01227356|"~     Patients with chronic myeloid leukemia in imatinib induced CHR are randomized between~     imatinib 400 mg daily and imatinib 400 mg daily + PegIntron 30 ug weekly.~      Primary endpoint: To compare at 12 months between the treatment arms the rate of Major~     Molecular Response (=99,9% tumour reduction) at 12 months~   "
178595|NCT01227343|"~     The aim of this study is to assess the impact of smoking on cortical GABA levels in males and~     females. Using magnetic resonance spectroscopy (MRS), we will examine the impact of sex and~     menstrual cycle phase on brain neurochemistry in healthy smokers and non-smokers. We~     hypothesize that female, but not male, smokers will have reduced cortical GABA levels~     compared to their non-smoking, sex-matched counterparts.~   "
178596|NCT01227330|"~     The purpose of this study is to pilot test a behavioral medication adherence (MA)~     intervention compared to control condition in older adults with low adherence to medication~     for hypercholesterolemia.~   "
178597|NCT01227317|"~     The purpose of this study is to evaluate the capacity of some novels biomarkers Procalcitonin~     (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial natriuretic peptide~     (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to stratify the risk in~     severe dyspnea.~   "
178598|NCT01227304|"~     -  test for volume responsiveness~        -  PiCCO-guided infusion over a pre-defined period of time~   "
178599|NCT01227291|"~     The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with~     elevated IOP.~   "
178600|NCT01227278|"~     To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary~     Disease (COPD) in Adults.~   "
178601|NCT01227265|"~     This is a study of the efficacy and safety of preladenant in adult participants with moderate~     to severe Parkinson's Disease (PD). While on this study, participants will continue to take~     their usual, prescribed, stable regimen of levodopa (L-dopa) or L-dopa plus adjunct PD~     medications and will be randomized to receive 2 mg preladenant, 5 mg preladenant, or placebo,~     twice daily, for 12 weeks. After that, participants may choose to receive additional~     treatment with preladenant. The primary hypothesis is that at least the 5 mg twice daily dose~     of preladenant is superior to placebo as measured by the change from Baseline to Week 12 in~     the mean off time.~   "
178602|NCT01227252|"~     This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of~     LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.~   "
178603|NCT01227239|"~     The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin~     combined with radiation by Phase I/II study.~      The purpose of this study is as follows,~        -  In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated~          dose (MTD).~        -  In phase II, to evaluate the antitumor effect (pCR rate) and the safety .~   "
178604|NCT01227226|"~     The effect of artificial tears on tear osmolarity~   "
178647|NCT01226654|"~     The primary purpose of this study is to detect changes in the brain that may be associated~     with multiple sclerosis. Results will be compared to age matched controls. Investigators will~     assess lesions by measuring T2 and T1 enhanced lesion volumes and magnetization transfer~     ratio histogram parameters (MTRHP) in patients with relapsing-remitting and~     secondary-progressive disease. This data will be correlated to total brain parenchymal volume~     as well as identifying the effect of MS lesions on the gray and white matter, volumetric~     disability, including Kurtzke Expanded Disability Status Scale (EDSS) and a specific battery~     of neuropsychological tests. Quantitative analysis of whole brain N-acetylaspartate (WBNAA),~     a reproducible measure of viable neuron number, using 1H MRS and compare the results to~     age-matched controls over duration of 5 years.~   "
178605|NCT01227213|"~     Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has~     improved the outcome of patients with several types of cancer remarkably. However, their~     application is hampered by side effects, such as development of hypertension with~     consequences for renal and cardiac function. Moreover patients treated with angiogenesis~     inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to~     change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients~     with various cancer diagnoses and therefore the clinical relevance of both short term and~     long lasting adverse events will translate into reduced quality of life. In addition,~     premature withdrawal of angiogenesis inhibitors due to side effects may result in lower~     response, shorter duration of response and possibly a shorter survival. Therefore, adequate~     treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is~     of relevance for the response rate, the duration of progression free survival and overall~     survival and for quality of life.~      Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment.~      Objective: The primary objective of the study is to investigate the effect of sunitinib on~     endothelial function, insulin sensitivity, renal function and renal blood flow.~      Study design: Single-centre non randomized observational study Study population: 30 Patients~     (>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.~   "
178606|NCT01227200|"~     The purpose of this study is to find if adding oral pain relievers as DYPIRON and TRAMADOL in~     addition to the local anesthesia injection, can help reducing the pain intensity in patients~     who diagnosed as Suffering from peritonsillar abscess (PTA)and treated by incision and~     drainage .~   "
178607|NCT01227187|"~     The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an~     anticoagulant at different dose levels during dialysis treatment in patients with End Stage~     Renal Disease (ESRD).~   "
178608|NCT01227174|"~     The purpose of this study is to determine if the use of propofol only to achieve procedural~     sedation for the removal of third molars is both safe and effective.~   "
178609|NCT01227161|"~     Choosing the adequate size of endotracheal tube(ETT) in pediatric patients is important in~     all anesthesiologists, pediatricians, and critical care specialists. Inadequate ETT size will~     results in soft tissue injury to trachea by means of the pressure, insufficient ventilation,~     and aspiration, therefore choosing the adequate ETT size has very important clinical aspect.~   "
178610|NCT01227148|"~     To compare the differences of urinary nitrogen excretion, nitrogen balance and clinical~     outcomes between tightly insulin therapy and conventional insulin therapy in the ICU.~   "
178611|NCT01227135|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Biological therapies, such as hydroxychloroquine, may~     stimulate the immune system in different ways and stop cancer cells from growing. It is not~     yet known whether imatinib mesylate is more effective when given with or without~     hydroxychloroquine in treating patients with chronic myeloid leukemia.~      PURPOSE: This randomized phase II trial is studying the side effects of giving imatinib~     mesylate with or without hydroxychloroquine and to see how well it works in treating patients~     with chronic myeloid leukemia.~   "
178612|NCT01227122|"~     Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase~     Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients~     with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of~     NGAL.~   "
178613|NCT01227109|"~     Infections pose a serious threat to cancer patients in chemotherapy. Prompt diagnosis and~     treatment is of paramount importance as infections may be life-threatening in~     immune-compromised individuals. Traditionally, the C-reactive protein (CRP) has been used as~     a marker of infection. However, the CRP is also often elevated in cancer patients and as a~     marker CRP may be unreliable in cancer patients. Other markers for infection includes~     procalcitonin which has been showed to be of some value for the diagnose of bacterial~     infections.~      This study examines procalcitonin as a potential marker of bacterial infection in cancer~     patients.~   "
178614|NCT01227096|"~     The purpose of this study is to determine whether electroacupuncture preconditioning would~     provide protection against myocardial Ischemic-Reperfusion injury and systemic inflammation~     in children undergoing CPB for repair of congenital heart defects.~   "
178615|NCT01227083|"~     Comparison of the responsiveness of two different asthma-specific QOL measures (AQLQ and~     cAQOL) in Korean patients with persistent asthma~   "
178616|NCT01227070|"~     This study is a longitudinal single-center pilot study designed to describe changes in lung~     function and levels of noninvasive biomarkers of airway inflammation in children ages 6-18~     years over two months following hospitalization for an acute exacerbation of asthma. Forty~     children ages 6-18 years with asthma who are admitted to Children's Hospital and Regional~     Medical Center (GCRC) for an asthma exacerbation will be enrolled and complete an initial~     study visit prior to hospital discharge. Children with asthma will be recruited from the~     inpatient medical unit. During their initial visit subjects will undergo a clinical~     assessment and perform spirometry to measure lung function. In addition, exhaled nitric oxide~     (eNO) concentration will be measured and a sample of exhaled breath condensate (eBC) will be~     collected during 20 minutes of tidal breathing. Breath condensate will be analyzed to~     determine the concentration of cysteinyl leukotrienes (CysLT), an important mediator of~     airway inflammation in asthma. Subjects with asthma will return to the GCRC pediatric~     satellite at Seattle Children's Hospital for follow-up study visits at 1 week, 2 weeks, and 4~     weeks following hospital discharge. During follow-up visits subjects will complete a~     questionnaire regarding symptoms and medication use since the most recent study visit, will~     perform spirometry, and have eNO concentration measured and breath condensate collected for~     CysLT analysis.~      The aims of this observational study are to:~        1. Assess the association of levels of exhaled nitric oxide and cysteinyl leukotrienes in~          breath condensate with measures of airflow obstruction (FEV1) and asthma symptoms~          during, and at one, two, and four weeks following hospital discharge for asthma~          exacerbation.~        2. Compare levels of exhaled nitric oxide and cysteinyl leukotrienes in breath condensate~          from children ages 6-18 years hospitalized for status asthmaticus to levels from~          age-matched healthy control subjects without asthma.~   "
178617|NCT01227057|"~     The purpose of this investigation is to examine treatment outcome of a new intervention for~     hoarding in older adults compared to standard case management for hoarding. The new~     intervention combines exposure therapy and cognitive remediation.~   "
178618|NCT01227044|"~     This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX)~     and counseling on highly active antiretroviral treatment (HAART) medication adherence in a~     cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse~     and/or dependence, and inadequate (< 95%) HAART adherence. All patients will receive a~     behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC~     incorporates the behavioral platform Medical Management (MM) from the National Institute on~     Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with~     Medication Coaching (MC), a manualized treatment designed to improve HAART medication~     adherence in HIV-infected patients with substance use disorders.~   "
178619|NCT01227031|"~     Androgenic alopecia, the common form of hair loss is a highly heritable disorder of~     considerable social significance affecting around 40% of adult men and women. A variety of~     genetic and environmental factors are likely to play a role in androgenetic alopecia. Genetic~     variants in the human androgen receptor gene (AR) have been reported to be associated with~     AGA in Caucasians. Other genes involved with hair loss also have been found. One of them~     being a gene on chromosome 3 (3q26). A recent genome-wide association study in 296~     individuals with male-pattern baldness and 347 controls had carried out and five SNPs on~     chromosome 20p11 were found to be highly significant association for AGA (rs2180439 combined~     P = 2.7 x 10(-15)). No interaction was detected with the X-chromosomal androgen receptor~     locus, suggesting that the 20p11 locus has a role in a yet-to-be-identified~     androgen-independent pathway.~      The total number of evaluated patients with androgenic alopecia will be at least 300. All~     patients will be further grouped as good responders or poor responders to conventional~     medications, such as topical minoxidil and systemic finasteride. Candidate genes potentially~     involved in gout and its treatment response will be selected from the published literatures;~     specifically, two resources of candidate genes will be selected: (i) genes which are known to~     directly link with androgenic alopecia, and (ii) genes are potentially implicated in~     particular pathways of androgen/estrogen receptors, metabolism and downstream signals, and~     genes involved in anti-oxidants or hair growth. The SNP genotyping will be performed by~     MALDI-TOF Mass Spectrometry. Data analysis will be performed by comparing SNPs allele~     frequency between good responder and poor responder to conventional medications of patients~     with androgenic alopecia and further comparing to the allele frequency of SNPs in healthy~     controls. A functional study will also be done to prove the genetic association.~   "
178620|NCT01227018|"~     RATIONALE: Heat shock protein (HSP)90 inhibitor STA-9090 may stop the growth of tumor cells~     by blocking some of the proteins needed for cell growth. PURPOSE: This phase II trial is~     studying how well hsp90 inhibitor STA-9090 works as second- or third-line therapy for the~     treatment of patients with metastatic pancreatic cancer.~   "
178621|NCT01227005|"~     The proposal will assess if patients who require massive transfusion can be accurately~     predicted early after emergency department arrival and assess if the use of stored whole~     blood during initial resuscitation will reduce transfusion needs compared to transfusion with~     component therapy and thus improve outcome.~   "
178622|NCT01226992|"~     Recurrent CDI is a growing problem with few treatment options that provide lasting effect.~     Fecal transplantation has been shown in several case series to be successful in controlling~     recurrent CDI. The current study is a non-blinded, randomized controlled trial comparing~     fecal transplantation with a 6 week taper of oral vancomycin for the treatment of refractory~     CDI. Approximately 146 patients will be enrolled over one year. Participants in the study~     will be followed for 120 days, and will be given the opportunity to cross over to the~     alternative intervention arm if a relapse in symptoms occurs. The primary outcome measure~     will be recurrence of toxin-confirmed CDI within 120 days of starting the intervention.~     Secondary outcomes include: early recurrence of symptoms within 14 days, relapse within 120~     days (same strain of C. difficile), attributable mortality, hospitalization and serious~     adverse events.~   "
178623|NCT01226979|"~     This research is being done to see how effective high-dose rate endorectal brachytherapy~     (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we want~     to try to decrease side effects and shorten the course of radiation treatment for patients~     with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This~     is a different form of radiation than what is normally given. With HDRBT, the radiation is~     given through an applicator placed into the bowel next to the tumor. The radiation is~     directed at the tumor and a small area around it.~   "
178624|NCT01226966|"~     This observational study is conducted in Europe. The aim of this non-interventional~     (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the~     conditions of use of Victoza® in daily medical practice in France.~   "
178625|NCT01226953|"~     This study will evaluate the safety and immunogenicity of booster dose of two commercially~     available vaccines used to prevent Haemophilus influenzae type b infections in children~     365-569 days of age~   "
178626|NCT01226927|"~     The optimal infusion technique (continuous rate vs. intermittent bolus) for peripheral nerve~     blocks has not been established. To our knowledge, this is the first study to compare the~     efficacy of an automated intermittent bolus technique to a continuous rate of infusion of~     local anesthetic in femoral nerve catheters. We hypothesized that the intermittent bolus~     technique would provide enhanced analgesia compared to a continuous infusion rate as assessed~     by intravenous patient-controlled analgesia (IV-PCA) hydromorphone consumption and visual~     analog scale (VAS) pain scores.~   "
178627|NCT01226914|"~     Primary Objectives~        -  To compare the amount of post-operative wound drainage between the group of patients in~          which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™~          placebo is utilized (Arm B).~        -  To compare the length of time to drain removal between Arm A and Arm B. Secondary~          objectives~        -  To compare the incident or rates of seroma, hematoma, and post-operative edema between~          the two groups.~        -  To compare the reported pain experienced in each group at selected time points using a~          standard numerical rating scale (NRS).~        -  To compare the length of hospital stay between the two groups of patients.~   "
178628|NCT01226901|"~     This study will evaluate whether oral administration of MK-4827 to participants with advanced~     solid tumors is generally safe and well tolerated.~   "
178629|NCT01226888|"~     Androgen deprivation therapy (ADT) is considered standard of care for prostate cancer.~     However, changes in the patients metabolism are usually seen as a result of hormone therapy.~     These changes include increased fat mass, decreased lean mass, weight gain, high blood~     cholesterol, increased incidence of diabetes, and possibly increased incidence of cardiac~     events such as heart attack. The researchers of this trial would like to learn if these~     change in body mass are affected by the presence of brown fat in the body. Brown fat is made~     up of fat cells that are stored in the body and generate heat to control body temperature.~     Levels of brown fat are at the highest in newborn babies and decrease over time into~     adulthood. The researchers of this trial would like to learn more about these changes in~     metabolism during prostate cancer treatment by studying the changes in brown fat during the~     first 12 months of hormone therapy.~   "
178630|NCT01226875|"~     Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL~     energy is focused on in order to break kidney stones and this energy can be varied in size~     from a narrow (or small) focal zone to a wide (or large) focal zone. This is a~     multi-centered, randomized study comparing the single treatment success rates of narrow and~     wide focal zones during SWL.~   "
178631|NCT01226862|"~     This study will promote the development and economic sustainability of telemedicine for acute~     stroke treatment.~   "
178632|NCT01226849|"~     Incorporation of rituximab to conventional chemotherapy (R-CHOP) has revolutionalized the~     frontline treatment of diffuse large B-cell lymphoma (DLBCL), one of the commonest subtype of~     lymphoma. Although the majority of patients are cured, there still remains a substantial~     number patients (20-30%) who will relapse despite upfront R-CHOP therapy. Recent studies have~     informed that in the rituximab era, the ability to salvage patients with relapsed DLBCL with~     the conventional salvage regimens like R-ICE or R-DHAP is significantly poorer than expected.~     For a patients who has been exposed to rituximab in the frontline, the response rate of~     conventional salvage chemotherapy is now a mere 51% (Coral Study). This suggests that~     relapses after rituximab exposure are more severe, strongly implying the presence of~     rituximab-resistant disease in additional to the selection of more aggressive subtypes of~     DLBCL which R-CHOP may not have a significant impact on. As R-CHOP is currently the frontline~     standard of care, more has to be done to augment the current available salvage regimens as a~     response rate of 51% is unacceptable.~      Incorporation of agents targeting rituximab-resistance and also the more aggressive subtype~     of DLBCL ( ABC subtype) is prudent in the salvage regimen. Bortezomib, a targeted novel agent~     has potent anti-tumor effects on its own. It has also been show clinically to be able to~     overcome the adverse risk conferred by the ABC subtype of DLBCL. In addition, preclinical~     studies have also demonstrated that bortezomib may enhance the biologic activity of rituximab~     through upregulation of CD20, the target of rituximab.~      The investigators hypothesize that adding bortezomib to salvage regimen of DLBCL will be more~     efficacious. Increasing the response rate will then allow more eligible patients to go on to~     autologous stem cell transplantation. The investigators intend to test the tolerability and~     efficacy of the combination of bortezomib with the R-ICE regimen, and attempt to correlate~     responses with histopathological and gene expression studies of tumor specimens.~   "
178633|NCT01226836|"~     The purpose of this study is to assess the feasibility and acceptability of the revised~     Living Well With COPD programme (LWWCOPD for Pulmonary Rehabilitation) when used to deliver~     the education component of pulmonary rehabilitation.~   "
178634|NCT01226823|"~     The study is a multicenter randomized double blind placebo controlled trial. The study will~     be conducted on pregnant women with a diagnosis of intrahepatic cholestasis of pregnancy~     (ICP) in third level hospitals (that are also Academic Hospitals).~      Pregnant women at the time of ICP diagnosis will be randomized in two groups:~      Group 1 - will receive placebo and obstetrical monitoring until delivery Group 2 - will~     receive UDCA at the dose of 20 mg/Kg/day and obstetrical monitoring until delivery.~      The hypotheses are that UDCA treatment will be superior to placebo and effective in:~      reducing the rate of prematurity; improving maternal biochemical parameters and symptoms.~   "
178635|NCT01226810|"~     Purpose of this study is to compare the image quality and diagnostic accuracy obtained with~     ultrafast solid state short SPECT in comparison with the routine SPECT protocol.~   "
178636|NCT01226797|"~     This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus~     infection and abnormal liver enzymes.~   "
178637|NCT01226784|"~     Effects of physical training and relaxation exercise on pathophysiological mechanisms and~     symptoms in finbromyalgia patients.~   "
178638|NCT01226771|"~     This is a randomized, open-label, parallel group, multicenter pilot study evaluating the~     efficacy and safety of alternative dosing of ribavirin vs. standard of care dosing in~     combination with peginterferon alpha-2a in interferon naïve patients with chronic hepatitis c~     genotype 1 infection.~   "
178639|NCT01226758|"~     The purpose of this research is to study the safety, tolerability and effectiveness of the~     investigational influenza vaccine in healthy volunteers infected with an attenuated influenza~     A virus.~   "
178640|NCT01226745|"~     The objective of this active-drug Extension Study is to evaluate the continuing safety and~     efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis~     (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 [NCT01081782]).~   "
178641|NCT01226732|"~     The investigators propose this Phase I trial of the combination of AUY922 and capecitabine to~     determine the maximum tolerated dose (MTD) in patients with advanced solid tumors. This~     combination treatment has potential applicability in tumor types where capecitabine or~     fluorouracil is a treatment option, including colorectal and breast cancer.~   "
178642|NCT01226719|"~     In this Phase II study the investigators plan to determine the overall response rate (ORR) of~     the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with~     liver-only metastatic KRAS wild-type colorectal cancer.~   "
178643|NCT01226706|"~     Non-neurogenic urinary urge incontinence (UUI) is a common quality of life disorder that~     causes people to feel an urgent need to urinate. Standard treatment for UUI includes~     behavior modification, pelvic floor exercises, anticholinergic medication, and less commonly,~     sacral neuromodulation. Unfortunately anticholinergic therapy is only moderately effective.~      Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond~     to standard therapy. Botulinum toxin A has been used in other studies to improve symptoms in~     neurogenic urinary incontinence, and a variety of lower urinary tract disorders. BTA has been~     used in other studies to improve the symptoms in urinary incontinence, migraines, spinal cord~     injuries and a variety of lower urinary tract disorders. However, the treatment of~     non-neurogenic urinary urge incontinence has not been examined in a well-controlled study.~      The primary purpose of this study is to determine the efficacy of botulinum toxin A (BTA) in~     the treatment of non-neurogenic urinary urge incontinence (UUI). The secondary objectives are~     to examine the side effects associated with BTA treatment and the impact this treatment has~     on patients' quality of life.~   "
178644|NCT01226693|"~     There is no difference in the rate and extent of absorption of the material sparing tablet~     (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3~     formulation without SLS.~   "
178645|NCT01226680|"~     This is a phase 2 study to further evaluate the safety and efficacy of tasocitinib~     (CP-690,550) in the subjects with moderate to severe dry eye disease. Both subjective and~     objective clinical endpoints will be measured for a duration of 12-week treatment.~   "
178646|NCT01226667|"~     A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week~     baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for~     one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID~     (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4~     weeks.It is proposed that use of flexible dosing combined with nightly dosing would have~     similar pain relief to fixed dosing, would improve adherence, would have less side effects~     and would be more likely to improve sleep.~   "
178648|NCT01226641|"~     The aim of this study is to determine the usefulness of a telemedicine system for the~     follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the~     telemedicine system will enhance compliance and thus reduce self-measured blood pressure.~   "
178649|NCT01226628|"~     The main purpose of this study to evaluate the safety and tolerability of CNTO 2476~     administered subretinally (beneath the retina) using the iTrack Model 275 micro catheter in~     patients with visual acuity (acuteness or clearness of vision) impairment associated with the~     geographic atrophy (GA: partial or complete wasting away of retinal layer below the retina)~     manifestation of age-related macular degeneration (AMD: medical condition which usually~     affects older adults and results in a loss of vision in the center of the visual field [the~     macula] because of damage to the retina).~   "
178650|NCT01226615|"~     The main purposes of this study are:~        -  to determine the effects of chondroitin sulphate on brain response to pain assessed~          through fMRI in patients with knee osteoarthritis.~        -  to investigate the relationship between treatment response detected by fMRI and the~          results of the different parameters of clinical assessment.~   "
178651|NCT01226602|"~     The purpose of this study is to determine if Ticagrelor increases the Adenosin induced~     coronary blood flow velocity.~   "
178652|NCT01226589|"~     Adverse drug events can occur commonly due to medication errors during the transition of care~     in a health care facility. Medication reconciliation is the process of comparing medications~     and providing an accurate medication list as a resource for prescribers, which is currently~     only being done upon inpatient admission at the CCI. The purpose of this study is to see if~     pharmacist medication reconciliation at discharge reduces unintentional medication~     discrepancies for inpatient discharges.~   "
178653|NCT01226576|"~     The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the~     potential to be a safe and effective non-invasive treatment for low to intermediate risk,~     organ-confined prostate cancer involving low incidence of morbidity. The study hypothesis~     will be tested by measuring treatment-related safety and initial effectiveness parameters in~     the ExAblate MRgFUS treated patients, as described above.~      Based on the result of this study, InSightec will initiate a larger study in an effort to~     approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS~     device.~   "
178654|NCT01226563|"~     The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for~     the prevention of ventricular remodeling and congestive heart failure when administered to~     subjects who had successful percutaneous coronary intervention with stent placement after ST~     segment elevation MI (STEMI).~   "
178655|NCT01226550|"~     This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of~     optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC)~     with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating~     doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis~     (PC).~   "
178656|NCT01226537|"~     Diabetes mellitus (DM) and its vascular complications are the one of the most prevalent~     diseases in the state of Qatar. It is a multifactorial disease associated with the~     development of retinopathy, nephropathy, neuropathy, cardiomyopathy, and severe vascular~     dysfunction. The complications of diabetes are caused by either insulin deficiency (type 1~     DM) or insulin resistance (type II DM).Unfortunately, effective and sustainable prevention~     programs of diabetes are limited, and treatment options for type II DM are restricted.~     Current therapy is based upon control of blood glucose, cholesterol and triglycerides,~     primarily through insulin replacement in type I diabetes or oral hypoglycemic agents and/or~     insulin replacement in type II diabetes. New therapies able to prevent vascular complications~     of diabetes are needed to decrease the occurrence of end organ damage and improve the quality~     of life of the people. Safe and effective nutritional supplements that could be given along~     with the regular treatment of the patients that might reduce the need for insulin replacement~     therapy provide tighter glucose control and protect against oxidative stress and the vascular~     pathology associated with diabetes mellitus are the need of the hour. Our hypothesis is that~     supplementation of Taurine in the diets of diabetic patients might reduce the dose or need~     for insulin replacement therapy and protect them against oxidative stress that is responsible~     for the complications of diabetes mellitus.~   "
178657|NCT01226524|"~     Immune thrombocytopenia (ITP) is an autoimmune disorder manifested as isolated low platelet~     count which results in a tendency for bleeding. Around 10% of childhood ITP does not reach~     resolution within 1 year thus becoming chronic ITP. Therapeutic modalities at present are~     aimed to achieve symptomatic relief, do not change the natural course of the disorder and are~     associated with potential side effects and increase cost. Thus, identifying a new therapy~     that would decrease the bleeding symptoms, without causing significant adverse effects, could~     be very beneficial. Preliminary reports demonstrate a beneficial role for Traditional Chinese~     medicine (TCM) in the treatment of ITP.~      Working hypothesis and aims: The use of TCM will improve the status of children with chronic~     ITP and thus will reduce the need to use conventional medications. The investigators aim to~     study whether in children with chronic ITP, supplementation with TCM, improves the bleeding~     symptoms and ITP-related quality of life (QOL) compared to the period prior to the~     intervention? Methods: The study includes three periods: 1st observation period (1 month),~     TMC period (3 months) and 2nd observation period (2 months). During all study periods the~     following data will be collected: bleeding symptoms, bleeding score, platelet count, need for~     conventional therapy, side effects of therapy and ITP-related QOL.~   "
178658|NCT01226511|"~     The purpose of this study is to find out if duloxetine [30-120 milligrams (mg)] given once a~     day by mouth for 10 weeks to children and adolescents, is better than placebo when treating~     Generalized Anxiety Disorder (GAD).~   "
178659|NCT01226498|"~     The objective of this study is to assess effects of the storage of PRBC on endothelial~     function, inflammation and platelet activation in healthy volunteers~   "
178660|NCT01226485|"~     The purpose of this study is to find a recommended dose level and schedule of dosing RXDX-109~     (formerly LY2940680) that can safely be taken by patients with advanced cancer. The study~     will also explore the changes in a cancer marker level in skin, hair follicles, buccal cells,~     and tumor cells. Finally, the study will help document any antitumor activity this drug may~     have.~   "
178661|NCT01226472|"~     This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous~     T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have~     relapsed after achieving a complete response in study, KW-0761-001.~   "
178665|NCT01226420|"~     Alefacept is a drug tht may reduce the number of T cells in circulation. This drug has been~     used in the treatment of psoriasis, which is a skin disorder also caused by T cells, like~     chronic GVHD. Information from studies in psoriasis and in other patients with GVHD suggests~     that this drug may help to treat chronic GVHD. Chronic GVHD is a medical condition that can~     develop after allogeneic stem cell transplantation. It occurs when the donor immune cells~     (the graft) attack and damage organs and tissue (the host). It is thought that T cells, a~     subtype of immune cells, are responsible for the tissue damage in chronic GVHD. In this~     research study we are looking to see how well Alefacept works in treating chronic GVHD that~     has not resolved after therapy with corticosteroids.~   "
178666|NCT01226407|"~     Open label, single dose and phase I study.~      The primary objective: To determine the maximum tolerated dose in Single dose~      The secondary objective: to evaluate the toxicity in administration to determine desirable~     dosing amount for phase II to evaluate tumor response in progressive solid cancer patients to~     evaluate pharmacokinetic/ pharmacodynamic profile.~   "
178667|NCT01226394|"~     Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal~     Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent~     and will be pre-registered. All patients will receive the current standard adjuvant treatment~     : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified~     if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of~     a recurrence is low but if this occurs, the patient will not be randomised and will be~     treated with the best known treatment. If the work-up is negative, patients will be~     randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC~     (experimental group).~   "
178668|NCT01226381|"~     This is a Crossover study, double-blind, randomized, controlled versus placebo.~   "
178669|NCT01226368|"~     Cervical cancer is a public health problem. In term of frequency and mortality, it represents~     in Martinique the third localization the most frequently diagnosed and the fifth cause of~     death by cancer. Cervical cancer is recognized as viro-inducted. Human papillomavirus (HPV)~     is the etiologic agent, as a necessary but not sufficient cause, in the cancer genesis. It is~     estimated than about 70 to 80% of women have been or will be infected with an HPV in their~     genital life, the risks factors being those of the others sexually transmitted diseases~     (STD). Most of HPV infection are transient, by spontaneous clearance in a few months of the~     virus under episomal form.~      Carcinogen risk is related to viral persistency which inducts the condition of cellular~     transformation.~      Infection persistency and subsequent carcinogen risk depend of the genotype concerned and of~     the host immunitary response.~      HIV infection is known to be associated with an higher prevalency of one or several infection~     with HPV-HR.~      However, no data about HIV/HPV coinfection prevalency are available nowadays in French~     overseas department of South America whereas they are the most affected by HIV.~   "
178670|NCT01226355|"~     A single blind, multi-center, randomized study is preformed to compare NOYA CoCr~     biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from~     MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr~     biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.~   "
178671|NCT01226342|"~     Transcutaneous electrical muscle stimulation (TCEMS) is well established intervention for~     rehabilitation of clinically stable patients with chronic obstructive pulmonary disease.~      The investigators have conceived this study to test whether TCEMS is feasible and tolerated~     by patients experiencing severe physical and psychical challenge of acutely exacerbated COPD.~   "
178672|NCT01226329|"~     The Right Question Project-Mental Health (RQP-MH) is a three-session health education~     intervention that teaches clients to participate effectively in mental health care. The~     methodology teaches clients to identify important issues of their illness or treatment,~     formulate questions, and devise plans to communicate and act in effective ways that address~     factors impacting their mental health care, with the expectation that this behavior will~     increase patient-provider communication and improve the therapeutic alliance between patient~     and provider.~      The investigators hypothesize that participants receiving the intervention will be more~     likely to engage and remain in mental health care, and that they will report higher~     activation and self-management scores as compared to control patients.~   "
178673|NCT01226316|"~     This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in~     patients with advanced cancer - and to identify a dose and schedule that can be used in the~     future. This study will also investigate how the body handles AZD5363 (ie, how quickly the~     body absorbs and removes the drug). This study will also investigate anti-tumour activity of~     AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid~     cancers bearing either AKT1 / PIK3CA or PTEN mutation.~   "
178674|NCT01226303|"~     This study is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who~     are PCR positive for the PML-RARα transcript or rarer retinoid sensitive subtypes (i.e.~     NPM-RAR-alpha, NuMA-RARalpha) and less than 21 years of age (for AIEOP, see appendix A).~   "
178675|NCT01226290|"~     The primary objective of this study is to establish the effectiveness and confirm the safety~     of the VizAblate System in ablating symptomatic uterine fibroids.~   "
178676|NCT01226277|"~     This is an open-label, multicenter, Phase I dose-escalation study designed to assess the~     safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid~     tumors or lymphoma.~   "
178677|NCT01226264|"~     Uterine cervical cancer is the second most common female malignancy. Therapy monitoring is~     essential to detect early recurrence. Diffusion-weighted magnetic resonance imaging is an~     emerging MRI imaging technique which has a potential value for the detection of primary and~     recurrent disease and for the assessment of response to therapy. The purpose of this project~     is to evaluate the predictive value of DWI during and after therapy in the prediction of~     recurrence of cervical uterine cancer. It will be considered whether DWI is able to provide~     early information about the response to therapy. This could enable the identification of~     less- or non-responsive tumors and in this way therapy can be adapted as soon as possible.~     Hence the investigators could offer the patient a more efficient treatment scheme and a~     reduction in toxicity related to the treatment could be established.~   "
178817|NCT01224418|"~     This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid~     Arthritis patients who showed unsuccessful response against methotrexate.~   "
178678|NCT01226251|"~     This study will assess the ability of a first prototype (strip) of a new chair side test to~     detect oral malodour. The strip is based on a new enzymatic reaction able to detect amines in~     saliva. Previous studies already showed significant correlations between oral malodor and the~     levels of amines in saliva. The limitation in their use as markers of oral malodour is the~     fact that the detection is usually carried out by complex techniques (High Performance Liquid~     Chromatography(HPLC)and Solid-Phase Micro Extraction-Gas Chromatography/Mass Spectrometry~     (SPME-GC/MS)). The results of the new enzymatic reaction can be evaluated by means of a~     colorimetric scale without necessity of extra apparatus.~      The study will be carried out with volunteers recruited at a multidisciplinary consultation~     for bad breath, organized at the University Hospital Leuven, Belgium.~      The paper strip will be used before the routine evaluation (organoleptic score (OS), the gold~     standard method for the diagnosis of halitosis and the level of volatile sulphur compounds~     (VSC), the most used adjunct tool to diagnose halitosis).~      The results of the new chair side test (strip) will be correlated with the OS and VSC~     measurements (OralChroma™, Halimeter®). The sensitivity, specificity and positive and~     negative predicted values of the new chair side test will be calculated. The cut-off values~     for a yes/no test will be determined. The meaning of color scores will be analyzed to assign~     a meaningful outcome to each score with relation to odor intensity.~   "
178679|NCT01226238|"~     Patients with major depression who are on a waiting list for psychotherapy usually suffer~     from considerable symptoms. Online self-help is one potential way to alleviate this~     suffering. The investigators want to study if patients awaiting psychotherapy benefit from~     online-self help. The investigators therefore randomly assign patients to either online~     self-help or no intervention and assess their depressive symptoms on a regular basis. The~     investigators hypothesize that online self-help will be superior to no intervention in~     alleviating depressive symptoms in depressed patients awaiting psychotherapy.~   "
178680|NCT01226225|"~     Cardiac rehabilitation, including physical training, has become accepted treatment following~     myocardial infarction, coronary stent implantation and coronary bypass operation. Besides~     modifying patients' risk profile for future coronary problems, the focus is on improving~     exercise capacity. The ability to be able to perform at a higher maximal level is a strong~     predictor for outcome (new cardiovascular events and mortality). The main purpose of this~     study is to evaluate whether aerobic interval training outweighs more classical moderate~     endurance training in improving exercise capacity. During interval training, patients perform~     exercise at high intensity, but for only a couple of minutes and then recover at a lower~     intensity. Such intervals are repeated. Preliminary evidence from smaller studies suggests~     that this type of training leads to a larger increase in exercise capacity, compared to the~     more traditional endurance training at moderate intensity.~      In addition, mechanisms that might explain how this improvement is achieved, as well as~     safety and impact on quality of life will be studied.~   "
178681|NCT01226212|"~     The objectives of this study are to use a nutritional change in the diet to improve gut~     health in older people. Ageing can result in major changes in the composition and activities~     of the bacteria in your gut, leading to a higher incidence of gastrointestinal infections,~     decreased intestinal motility and impaired bowel function as people get older. This can~     result in constipation or diarrhoea, increased levels of inflammation and reduced immune~     response to infection. Therefore, individuals aged 65 or over could benefit from safe and~     effective interventions that maintain a healthy balance of gut bacteria as well as restoring~     the immune response. Bacteria in the gut are known to promote health. Eating foods containing~     beneficial bacteria for example (probiotics) or food which contain substrates for the~     bacteria to grow on (prebiotics) can improve the balance of gut bacteria. The investigators~     will use a synbiotic with known anti-inflammatory properties, comprising a probiotic~     Bifidobacterium longum strain and inulin (Synergy 1), The synbiotic has been previously shown~     to be beneficial in reducing inflammation and to increase levels of beneficial bacteria in~     the gut in two studies in patients with inflammatory bowel disease. The investigators would~     now for these reasons, like to determine the effects of our Synbiotic on the gut bacteria and~     immune function of older individuals in a double-blinded, crossover, placebo controlled,~     randomised investigation involving 40 volunteers for three months. The trial is designed so~     that participants will be assigned to receive the Synbiotic preparation or the placebo for~     the first four weeks, this will be followed by four weeks without treatment, and then they~     will switch to the opposite preparation for another four weeks.~   "
178682|NCT01226199|"~     Smoking is the most important risk factor of COPD, but only a fourth of smokers had COPD in~     their life. There are also healthy smokers without evidence of COPD. Investigators~     hypothesize that innate immunity may affect this difference between COPD patients and healthy~     smokers, because TLR4 is the receptor of LPS, which is the one of important substance in~     cigarette. Investigators will measure TLR2 and TLR4 expression in lung tissue of patients~     whose lung will be resected. Investigators will compare the level of expression between COPD~     patients and healthy smokers.~   "
178683|NCT01226186|"~     The study aims to compare two post operative pain management strategy's, traditional nurse~     dispensed pain control versus patient self medication. The investigators aim to establish if~     patients who self medicate have differing pain levels than those who take nurse dispensed~     oral morphine.~   "
178684|NCT01226173|"~     The purpose of the study is to screen blood donors for the presence of NS1 antigen of the~     dengue virus at the American Red Cross in Puerto Rico region (and Monroe County, Florida)~     using the Platelia Dengue NS1 Ag enzyme immunoassay.~   "
178685|NCT01226160|"~     This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative~     face-down positioning on the outcome of macular hole surgery.~   "
178686|NCT01226147|"~     An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene~     to patients of Lupus Nephritis~   "
178699|NCT01225978|"~     The clinical use of genetic testing is expanding and, as a result, the number of variants~     identified in patients is growing. Knowledge of the clinical impact of these variants~     improves over time. However, the combination of more testing and the rapid evolution of~     genetic knowledge make it impossible for clinicians to fully account for the latest~     implications of their patients' genetic profiles as patient care decisions are made. This~     proposed study plans to enhance and evaluate IT infrastructure developed to provide timely~     genetic variant updates and patient search functionality to clinicians to assist in~     optimizing patient care.~   "
178687|NCT01226134|"~     Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor~     abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal,~     hypersensitivity of the afferent nerves of the gut, psychological disturbances and central~     nervous system dysfunction have been proposed.~      Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only~     small benefits relative to placebo have been found with histamine H2 receptor antagonists,~     proton pump inhibitor and Helicobacter pylori eradication.~      Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is~     currently indicated for patients with various upper GI symptoms.~      This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic~     acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking~     test)and symptoms in FD patients~   "
178688|NCT01226121|"~     The purpose of this study is to determine if of manipulation of digits following collagenase~     injection for treatment of Dupuytren's contracture is effected by the amount of time between~     injection and manipulation.~   "
178689|NCT01226108|"~     OBJECTIVES:~      Primary Objective The primary objective will be a decrease of inconvenience with at least 10%~     for at least 50% of the subjects.~      Secondary Objectives~      The secondary objective will be to:~      To evaluate if the patch can improve the tinnitus patient's quality of life and sleep~     quality.~      METHODOLOGY~      Study Design:~      An open safety and performance clinical investigation of the antinitus patch in patients with~     manifested tinnitus.~      Treatment Duration:~      1 patch per day for 3 weeks~      Primary Endpoint:~      Tinnitus severity questionnaire (TSQ)~      Performance Parameters:~      Tinnitus severity questionnaire (TSQ) and numerical rating scale (NRS) measuring tinnitus~     annoyance.~      Quality of life and sleep quality~      Safety Parameters: Adverse Reactions~   "
178690|NCT01226095|"~     This is a prospective, multi-center, post-marketing observational study to evaluate the~     effectiveness and compliance of ibuprofen in a sustained release form in the treatment of~     Egyptian osteoarthritic patients.~   "
178691|NCT01226082|"~     tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents~     applied via scalp electrodes to modulate the level of cortical excitability.Several studies~     have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease~     pain sensation and to increase pain threshold in healthy subjects and in chronic pain~     patients. The aim of this study was to test whether daily sessions of anodal tDCS repeated~     for 5 consecutive days may be effective in reducing pain in a large number of chronic pain~     patients. The cathode is usually applied over the right forhead above the eye. The aim of the~     study is to test whether daily sessions of tDCS repeated for 5 consecutive days will~     influence on ophthalmologic parametrs.~   "
178692|NCT01226069|"~     The aim of the interventional study is to compare the different treatment modalities in~     reducing erythema size and rate of resolving phlebitis.~   "
178693|NCT01226056|"~     Sorafenib is an oral multikinase inhibitor and among its targets are several RTKs involved in~     tumor genesis (Raf, Flt-3, c-Kit and RET) and angiogenesis (VEGFR1, 2 and 3 and PDGFRß).~     Therefore sorafenib inhibits tumor growth by a dual mechanism, acting either directly on the~     tumor (through inhibition of Raf and Kit signaling) and/or on tumor angiogenesis (through~     inhibition of VEGFR and PDGFR signaling.~      RAD001 is a novel derivative of rapamycin. It selectively inhibits mTOR directly blocking~     tumor cells by preventing tumor cell growth and proliferation and indirectly by inhibiting~     angiogenesis (via potent inhibition of the HIF-1 and consequently VEGF production).~      Targeting mTOR in combination with sorafenib might lead to more profound effects on tumor~     cell biology than could be achieved through individual targeting of some proteins.~      New drugs have often met only limited success since not always target pathways responsible~     for tumor development and growth are targeted. To overcome this problem, the specific~     pathways targeted by the investigators two drugs will be analyzed in each single patient~     before the inclusion.~   "
178694|NCT01226043|"~     Primary Objective:~      To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the~     end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)~      Secondary Objectives:~      To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following~     parameters:~      Randomization/Crossover phase:~        -  Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus~          vial and syringe~      Re-randomization phase:~        -  Change in Fasting Plasma Glucose (FPG) from week 4 to week 10~        -  Percentage of patients achieving FPG<110 mg/dL at week 10~        -  Change in Lantus dose injected per day (U) from week 4 to week 10~      Observational phase:~        -  Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (<7%) at week 40~        -  Time to first observation of HbA1c<7% during the observational phase~        -  Percentage of patients who discontinue Investigational Product (IP) during the~          observational phase due to dissatisfaction with their current device~      All phases:~        -  Percentage of patients who discontinue IP during each phase of the study~        -  Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)~   "
178695|NCT01226030|"~     This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With~     Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES~     will be selected to perform the pharmacokinetic study profiles.~   "
178696|NCT01226017|"~     The purpose of this pilot study is to investigate the possible change of Oxytocin level in~     human blood after positive interaction with farm animals.~   "
178697|NCT01226004|"~     To address pertinent questions regarding the utilization of stereotactic Body Radiotherapy~     (SBRT) to treat prostate cancer. The Florida Robotic Radiosurgery Association (FRRA) launched~     the first registry for prostate cancer patients treated with SBRT. The registry is designed~     to track surrogate treatment endpoints including prostate specific antigen (PSA),~     international prostate symptom score (IPSS),sexual health in men (SHIM), and visual analogue~     scale (VAS) scores, in addition to physical and survival data. Utilizing an independent~     vendor (Advertek, Inc.) experienced with the design and implementation of similar electronic~     registries, FRRA developed a data collection tool that staff members with a basic medical~     background can use to register and upload pertinent patient data, requiring no more than 20~     to 30 minutes per patient. Participating patients will be monitored in follow-up for three~     years, with analysis and publication of the results semi-annually.~   "
178704|NCT01225913|"~     The purpose of this study is to evaluate the site and mechanisms responsible for expiratory~     airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to~     severe persistent expiratory airflow obstruction. Treatment will include inhaled~     corticosteroids and long acting beta2agonists. The investigators are interested in~     determining whether the large and/or small airways are the predominant site of airflow~     limitation. The investigators are also interested in determining whether intrinsic small~     airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow~     limitation. The investigators are also interested to evaluate the role of varying doses of~     inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric~     oxide as surrogate markers of inflammation. For comparison purposes, spirometry and~     measurements of exhaled nitric oxide will also be obtained if possible during a naturally~     occurring exacerbation of asthma.~   "
178705|NCT01225887|"~     This phase II trial studies the side effects and how well nintedanib works in treating~     patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the~     tumor.~   "
178706|NCT01225874|"~     RATIONALE: Studying samples of blood or bone marrow from patients with cancer in the~     laboratory may help doctors predict how well patients will respond to treatment. Drugs used~     in chemotherapy work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more cancer cells.~      PURPOSE: This trial is studying biomarkers to classify young patients with acute~     lymphoblastic leukemia (ALL) and remission induction therapy in young patients with~     B-precursor ALL.~   "
178707|NCT01225861|"~     The primary objective of the study is the descriptive analysis of incidence & severity of~     side effects & reasons for discontinuation of the treatment of chronic pain with transdermal~     analgesic Buprenorphine patches.~   "
178708|NCT01225848|"~     This is a randomized Blinded Phase II trial of Maintenance SU011248 Versus Placebo Post~     Chemotherapy for Patients With Advanced Urothelial Carcinoma.~   "
178709|NCT01225835|"~     This study is aimed to demonstrate that highly purified Menotrophin produces significant~     lower progesterone serum levels during the follicular phase in comparison to Follitropin~     alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and~     to investigate if the progesterone serum levels might be a useful predictor for the success~     rate of the ongoing pregnancy rates~   "
178710|NCT01225822|"~     The primary objective of this study is to establish the dose-response relationship with~     regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg~     b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients~     undergoing primary elective total hip and knee replacement.~   "
178711|NCT01225809|"~     Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term~     follow-up period to get more information regarding the safety profile of AFFITOPE AD01.~   "
178712|NCT01225796|"~     The purpose of this study is to compare the effect of sodium bicarbonate versus no sodium~     bicarbonate treatment on urinary ammonia levels and urinary transforming growth factor-beta1~     (TGF-beta1) excretion in renal transplant patients with low-to-normal serum bicarbonate~     levels (20 - 28 mmol/L).~   "
178713|NCT01225783|"~     Lymphedema is a common, chronic, side effect resulting from the treatment of breast~     cancer.Insufficiency in the lymphatic system causes edema in the upper limb. The accepted~     conservative treatment is based on the anatomy and physiology of the lymphatic system. The~     aim of the treatment is to reduce the volume of the upper limb by, initial, intensive~     treatment and then to keep the arm volume at this reduced level.The measurement of limb~     volume involves measuring the circumference of the arm at defined points and then with the~     use of a formula the volume of the arm can be calculated. After intensive therapy is complete~     the responsibility for measuring limb volume moves to the patient. This study will examine~     the reliability and validity of self measurement of limb volume. The investigators will~     compare the results of self measurement using the accepted plastic tapemeasure against a~     paper tape measure adapted for self measurement.Both methods will be compared to the gold~     standard volume displacement. In the study there will be two meetings with the subjects where~     the patient and physiotherapist will use the three methods.~   "
178714|NCT01225770|"~     Experimental and clinical studies in adults have reported that green tea catechins prevent~     influenza infection. In this clinical randomized study, the investigators aimed to determine~     the effects of gargling with green tea on the prophylaxis of influenza infection among high~     school teenagers.~   "
178715|NCT01225757|"~     Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is performed in~     patients with peritoneal tumors. Classically, this procedure is prolonged in duration and~     involves significant fluid shifts. Patients receive a large amount of volume replacement~     during this procedure (between 10 and 20 liters). The traditional methods to monitor adequacy~     of volume replacement are measurement of urine output and central venous pressure. There are~     drawbacks of any method of intravascular volume status measurement which may lead to over or~     under replacement of fluids. If fluid replacement is underestimated, the patient may suffer~     from adverse effects such as hypotension and renal dysfunction. However, the excessive~     administration of fluids may lead to other adverse events, including cardiac dysrhythmias and~     heart failure. The hypothesis of this study is that patients in whom volume status is~     maintained by utilizing a transesophageal echocardiogram will have better maintenance of~     fluid status while avoiding intravascular volume overload.~   "
178725|NCT01225627|"~     This is a single-centre randomized controlled clinical trial which will enroll COPD patients~     in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV, hospitalized~     due to acute exacerbation. Patients will be randomised in a 1:1 fashion to intervention~     group, which will have care organized by discharge coordinator, and control group which will~     receive care as usual. The primary endpoint of this study is time to hospitalization due to~     COPD worsening. Data will be collected at baseline, at the time of hospital discharge, and at~     following time-points after the hospital discharge: 48 hours, 7-10 days, 30 days, 90 days,~     and 180 days.~   "
178818|NCT01224405|"~     The study includes the recruitment of patients with advanced prostate cancer resistant to~     chemical castration This is a multicenter prospective trial randomized phase III~   "
178716|NCT01225744|"~     A Phase II trial to demonstrate the response rate, using the Response evaluation criteria in~     solid tumours (RECIST) criteria, of patients with locally advanced / metastatic colorectal~     cancer treated with combination of irinotecan, oxaliplatin, UFT and cetuximab.~      ENDPOINTS Primary: Objective response rate (RECIST) Secondary: Progression free survival~     (PFS), Overall survival (OS) Toxicity (CTCAE), Resectability of liver, lung and pelvic~     disease after chemotherapy, Time to progression (TTP).~      POPULATION: The trial aims to recruit 50 patients with inoperable, metastatic colorectal~     cancer ELIGIBILITY: Histologically confirmed colorectal adenocarcinoma Normal haematology and~     adequate renal and liver function Written informed consent and able to attend follow-up for~     at least 3 months TREATMENT 4 weekly cycles of chemotherapy with alternating irinotecan (day~     1) and oxaliplatin(day 15). Cetuximab every 2 weeks and oral UFT with Leucovorin for 3 weeks~     every 4 weeks.~      DURATION First patient recruited April 2009. Accrual to take place over 24 months Follow-up~     will continue until death or for a minimum of 3 years~   "
178717|NCT01225731|"~     This is a response-driven study of tildrakuzumab for the treatment of moderate to severe~     chronic plaque psoriasis. The primary study hypothesis is that one or more doses of~     tildrakizumab will be superior to placebo for the treatment of psoriasis.~   "
178718|NCT01225718|"~     This is a retrospective chart review of all patients cared for at Monroe Carell Jr.~     Children's Hospital at Vanderbilt including the following:~        -  patients between 2007-2009 with malignancy, Langerhans cell histiocytosis (LCH) or~          hemophagocytic lymphohistiocytosis (HLH) and a central venous catheter who were under 23~          years of age at time of diagnosis in order to ascertain the associated symptoms,~          management and outcome of all episodes of non-neutropenic fever.~        -  to identify a subset of low-risk patients that can be safely managed without use of~          empiric antibiotics.~   "
178719|NCT01225705|"~     Current European AIDS Clinical Society (EACS) guidelines for the treatment of HIV infection~     recommend a combination antiretroviral regimen composed of two nucleoside reverse~     transcriptase inhibitors plus a ritonavir boosted protease inhibitor or a non-nucleoside~     reverse transcriptase inhibitor.~      The non-nucleoside reverse transcriptase inhibitors licensed for naïve patients - nevirapine~     and efavirenz - have both been asociated with increased rates of hepatotoxicity (nevirapine)~     and CNS toxicity (efavirenz) in HIV/HCV co-infected patients. Although PI-based therapy has~     dramatically reduced morbidity and mortality, it has been limited by complex dosing regimens~     and toxicities, leading to adherence challenges. Varying degree of liver insufficiency may~     necessitate pharmacokinetic monitoring of the protease inhibitor and may necessitate dose~     adjustments. In HIV/HCV co-infected patients HAART based on another class of antiretrovirals~     than NNRTI or PI may thus offer advantages with regard to adverse events and thus long-term~     efficacy.~      The overall intention of this trial is to examine in a non-inferiority design the safety and~     efficacy of a raltegravir based HAART with a standard-of-care HAART in HIV-/HCV co-infected~     patients. The standard of care used in this study will be atazanavir/ritonavir. All patients~     will in addition receive a fixed combination of tenofovir and emtricitabine.~      The primary end-point is the rate of hepatotoxic events, defined by ALT elevations.~   "
178720|NCT01225692|"~     The goals of this study are to identify outcome indicators of optimal care for brain injury~     patients, including pre-hospital care, prompt delivery to neurosurgical care and access to~     early rehabilitation services. Nova Scotia's centralized Neurosurgical services and~     integrated provincial Emergency Health Services provide a rich opportunity to construct a~     cohesive, integrated data management system. This system will allow us to answer important~     research questions related to the outcomes, care and prevention of brain trauma.~      Retrospective data collection The retrospective arm of the BTO study has created full data~     sets and care pathways from multiple sources covering the continuum of brain trauma care.~     Investigators continue to analyze this large amount of data and prepare it for publication.~      Prospective data Collection Patients with a major head injury (initial GCS 3-12), have been~     considered for enrollment in the BTO study.The prospective arm of the BTO study has 52~     patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients are~     participating in long term follow up at 6, 12 and 24 months post injury for assessment of~     qualitative and quantitative outcomes. Completion of patient follow up will be in June 2009.~   "
178721|NCT01225679|"~     Congenital central hypoventilation syndrome (CCHS) is a rare disorder of respiratory control~     characterized by ventilatory impairment that results in arterial hypoxemia. Although patients~     typically present this disease as newborns and rarely in later infancy, there have been~     reports of patients presenting with CCHS in adulthood.~      The present study reports a unique familial case in which the father (proband) presented~     late-onset CCHS with an expansion mutation of the Phox2B gene that was confirmed by genetic~     analysis. Surprisingly, the proband did not report any manifestation of the disease during~     childhood, and the disease progressed following an insidious course until adulthood. At the~     time of diagnosis, he did not present signs of pulmonary hypertension and right-side heart~     failure. The patient responded well to nocturnal invasive ventilation. In contrast, his son~     presented CCHS as a newborn with the full complement of symptoms while his daughter did not.~      The present report shows that CCHS cases characterized by a mutated Phox2 gene can progress~     without many symptoms and that the treatment approach used here was efficient for controlling~     the course of the disease. Furthermore, this case indicates that incomplete penetrance can~     occur. Genetic screening of family members is mandatory to evaluate the reproductive risk of~     the disease, especially because asymptomatic mutation carriers may be at high risk to develop~     the disease and transmit it to the next generation.~   "
178722|NCT01225666|"~     This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics~     (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an~     every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient~     Adult (GHDA) patients who previously were on a stable r-hGH treatment. An additional~     extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose~     selection for future trials.~   "
178723|NCT01225653|"~     Randomized double-blinded two-year intervention study with topical application of latanoprost~     or placebo eye drops in patients with diabetic retinopathy.~   "
178724|NCT01225640|"~     PNU-100480 is being developed for the treatment of both drug resistant and sensitive~     tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480~     when given for 14 days to treatment-naive patients with drug-sensitive pulmonary~     tuberculosis.~   "
178726|NCT01225614|"~     This is a multicenter randomized controlled open labeled study testing efficacy and tolerance~     of early launching of night non invasive ventilation in patients with myotonic dystrophy type~     1(DM1). The object of this project is to estimate the effects of the early introduction of~     non invasive ventilation on the arisen of complication (non expected hospitalization,~     tracheostomy even death) with regard to a simple respiratory follow-up in patients affected~     by myotonic dystrophy.~   "
178727|NCT01225601|"~     Study objectives:~        -  To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell~          histiocytosis~        -  To assess the impact of tobacco discontinuation~        -  Study Design Multicentric prospective cohort study~        -  Main endpoint: Pulmonary deterioration~        -  Sample size : 40 patients~   "
178728|NCT01225575|"~     This is a prospective, randomised, open label, multicentre Phase II clinical trial to~     investigate the efficacy and safety of the treatment of large defects with 3 different doses~     of the autologous chondrocyte transplantation product co.don chondrosphere® (ACT3D-CS) in~     subjects with cartilage defects of the knee.~      After screening visit patients were booked for arthroscopy and had their cells harvesting~     from healthy cartilage. After the arthroscopy the patients were randomised in one of the~     three dose-groups. The cells are cultivated for 8-10 weeks in vitro to develope 3-dimensional~     spheroids, that are transplanted in an open knee procedure (treatment surgery)into the~     defect. Patients of all dose groups subsequently followed the same rehabilitation program and~     had post-surgery visits. The 12-month-visit is defined as final assessment. Then patients~     have follow-up assessments up to 60 months.~   "
178729|NCT01225562|"~     This study is being carried out to see if a new drug called ticagrelor given twice daily in~     addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death~     from heart disease, heart attack, or stroke).~   "
178730|NCT01225549|"~     The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma~     challenged with an inhaled allergen.~   "
178731|NCT01225536|"~     This is an open-label, Phase 1, dose escalation study of oral ARQ 736 administered to~     subjects with advanced solid tumors harboring the mutation. The study is designed to explore~     the safety, tolerability, pharmacokinetics and pharmacodynamics of ARQ 736 and to define a~     recommended Phase 2 dose of ARQ 736.~   "
178732|NCT01225523|"~     To assess whether or not a perioperative therapy with surgery can improve the outcomes among~     patients with potentially curable squamous carcinoma of esophagus as compared to a~     preoperative chemotherapy followed by surgery~   "
178733|NCT01225510|"~     Angiopoietin-2 (Ang-2) is a protein in the body which destabilizes blood vessels and is~     important in stimulating tumor blood vessels. There is evidence suggesting that Ang-2 may be~     important for the growth and progression of Glioblastoma multiforme (GBM). PF- 04856884~     (CVX-060) is a compound which binds Ang-2 and prevents its activity. The hypothesis is that~     PF-04856884 will be safe and effective in patients with recurrent Glioblastoma multiforme~     (GBM).~   "
178734|NCT01225497|"~     Chronic pain and disability are unfortunately common in Achilles tendon pain. Outcome after~     surgery is often poor. Also tendon pain can be resistant to treatment and may lead to~     cessation of hobbies or careers.~      Recently eccentric exercise (defined as muscle loading where tension develops as physical~     lengthening occurs) has become a cornerstone in managing tendon pain due to an increasing~     amount of favorable research. Eccentric exercises are considered to be non-invasive, safe,~     and appear to be important for a successful outcome.~      One exercise program has been extensively adopted in research and clinical practice for~     Achilles pain. It recommends individuals perform 180 repetitions a day. However there appears~     to be little scientific rationale for this number. Consequently there may be significant~     implications for patient compliance, satisfaction, and overall treatment efficacy in a~     strategy which is encouraged to be uncomfortable.~      Fifty two adults (18-70 years old), with mid-Achilles tendon pain will be randomised to~     standard treatment (180 repetitions) or to a group where individuals are allowed to do what~     they can. Participants will be recruited from participating physiotherapy departments (health~     centres and hospital departments) across NHS Forth Valley. All individuals will be required~     to complete the same type of eccentric exercise for six weeks attending an initial assessment~     and two follow-up appointments at three and six weeks. Thereafter participants will be~     discharged if better, or continue with individual care where appropriate.~      It is hoped this pilot study will establish if future larger scale investigation is warranted~     examining whether it is necessary to subject individuals to 180 repetitions a day in an~     activity recommended to be uncomfortable. Also will participant satisfaction differ between~     exercise groups? If further investigation is warranted this pilot may provide population~     specific data for future sample size calculations, and may provide a suitable methodology for~     such investigations.~   "
178735|NCT01225484|"~     The purpose of this study is to compare two accepted methods of pain control in knee~     arthroplasty surgery.The first method combines the periarticular injection of ropivacaine~     with continuous blockade of the femoral nerve.The second method uses periarticular~     infiltration of ropivacaine in combination with an bolus of ropivacaine into an~     intraarticular catheter placed intraoperatively followed by a continuous intraarticular~     infusion of ropivacaine. All patient will also receive a sustained-release oral opioid and~     oral rescue opioids determined by pain severity using the Visual Analog Scale (VAS)~   "
178736|NCT01225471|"~     The purpose of this study is to evaluate the safety and clinical efficacy of novel peptide~     vaccination for advanced prostate cancer~   "
178737|NCT01225458|"~     The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly~     patients aged over 75 years with renal insufficiency stage 5 will be included in the study~     after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in~     the exclusive nephrology follow-up arm will continue their usual follow-up; 250 patients in~     the geriatric follow-up arm will have both their usual nephrology follow-up and a geriatric~     follow-up.~      The aim of the study is to determine if a systematized gerontologist evaluation delay the~     occurrence of a composite primary endpoint : death, dementia, depression and severe~     dependency. The hypothesis is that the functional and vital prognosis of a patient with renal~     insufficiency depends not only on common and classical factors but also on cognitive and~     psychological functions and dependence, particularly in elderly patients.~   "
178755|NCT01225224|"~     A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of~     ASP015K in healthy nonelderly men.~   "
178756|NCT01225211|"~     The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and~     pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with~     ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the~     F508del-CFTR mutation.~   "
178757|NCT01225198|"~     The investigators hypothesis is that a new, revised formulation of a vitamin/mineral~     supplement will result in:~        1. improvement of nutritional status in some children/adults with autism, and~        2. reduction of some of the symptoms of autism in some children~   "
178738|NCT01225445|"~     Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in~     the world. The treatment of IgA nephropathy with normal renal function and minimal~     proteinuria is unknown. Since angiotensin-converting enzyme (ACE) inhibitors reduce~     proteinuria and retard the rate of decline of renal function in chronic proteinuric~     nephropathies, including IgA nephropathy. The investigators conduct a randomized control~     study to evaluate the efficacy of ACE inhibitor in the treatment of early IgA nephropathy.~     Sixty patients with biopsy-proven IgA nephropathy and minimal proteinuria are recruited. They~     will be randomized to ramipril for 5 years or no treatment. Blood pressure, proteinuria and~     renal function will be monitored. This study will explore the effects of ACE inhibitor in the~     treatment of early IgA nephropathy, which is a major cause of dialysis-dependent renal~     failure.~   "
178739|NCT01225432|"~     To assess the carryover effect of an innovative new gait training program on physiological~     and functional gait performance in persons with a traumatic lower extremity amputation. A~     second objective is to clarify the relationship between gait biomechanics (joint and sgment~     kinematics and energy cost.~   "
178740|NCT01225419|"~     This is a prospective Phase II, monocentre study.~   "
178741|NCT01225406|"~     This is an observational cohort study of virologic and immunologic outcome after at least 48~     weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be~     enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral~     (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy~     and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as~     darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will~     help the Thai government in planning its strategy to provide third line ARV therapy to~     children within the national program.~   "
178742|NCT01225393|"~     This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter~     study enrolling patients with active rheumatoid arthritis (RA).~   "
178743|NCT01225380|"~     This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of~     response-guided duration of therapy with GS-9190 and GS-9256 in combination with~     Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and~     safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and~     Ribavirin (Copegus®) will be evaluated.~   "
178744|NCT01225367|"~     The study is a prospective open evaluating study of Ultrasound/Doppler application to the~     chest cavity intended to detect and characterize pathologies of the pulmonary and~     cardio-vascular system.~      The system is a noninvasive non-imaging device designated to monitor flow and movement~     velocity and display the data continuously.~   "
178745|NCT01225354|"~     The purpose of this study is to determine if Radiesse injections to the cheeks result in an~     altered and improved first impression and self esteem.~   "
178746|NCT01225341|"~     The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A~     as a preventative measure for Herpes Labialis.~   "
178747|NCT01225328|"~     This project will develop and preliminarily evaluate an intervention to assist young-middle~     adult rural breast cancer survivors to overcome functional impairments related to their~     cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social~     and vocational responsibilities and recreational interests and are at increased risk of~     developing long-term difficulties performing these valued activities (participation~     restrictions). Rural cancer survivors are medically underserved and due to distance and~     geographic isolation face significant barriers to accessing traditional rehabilitation~     services. Alternative rehabilitation approaches are sorely needed for this population. Based~     on previous research with cancer and other medical populations a working draft of a treatment~     manual using a telephone-delivered Behavioral Activation and Problem Solving (BA/PS)~     intervention has been designed. Prior to testing the intervention in a randomized clinical~     trial, additional work must be completed. The specific aims of this study are to a. refine~     the BA/PS treatment manual, b. develop and apply treatment integrity measures for the BA/PS~     manual, c. assess participation restrictions and associated outcomes, d. preliminarily assess~     the immediate and maintenance effects of BA/PS, and e. examine mediators and moderators of~     BA/PS effects based on our Self Regulation model of functional recovery. 188 young-middle~     adult breast cancer survivors will be screened for participation restrictions following~     cancer treatment and 40 survivors with participation restrictions will receive BA/PS~     delivered by phone. BA/PS participants will be assessed for treatment effectiveness and~     interviewed regarding their experiences during treatment to provide information for refining~     the manual. The long-term objective of this line of research is to develop effective and~     feasible treatments for the medical and psychosocial consequences of cancer and its treatment~     in medically underserved cancer survivors (e.g., rural populations).~   "
178748|NCT01225315|"~     This study will assess the efficacy and safety of ACT-129968 in subjects with partly~     controlled asthma on reliever therapy only.~   "
178749|NCT01225302|"~     The primary objective of this study is to assess the safety and pharmacokinetics of~     linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin~     and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer~     (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in~     the subjects as first-line treatment.~   "
178750|NCT01225289|"~     The aim of this study is to study the comparison between the effects of supplementation with~     25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and~     Th1/Th2 balance in patients with Multiple Sclerosis.~   "
178751|NCT01225276|"~     NewGam (current working title for a new IGIV formulation) is a newly developed human normal~     immunoglobulin solution ready for intravenous administration (IGIV). This study will evaluate~     the safety and efficacy of three different dosages of NewGam 10% in patients with Chronic~     Inflammatory Demyelinating Polyradiculoneuropathy.~   "
178752|NCT01225263|"~     The investigators are studying if taking simvastatin and vitamin D together will help prevent~     episodic migraines. Simvastatin is an FDA approved drug that is typically used to treat high~     cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a vitamin found in~     certain foods like some types of fish, and in nutritional supplements. This study is 9 months~     long. Some people who participate will receive simvastatin and vitamin D, and some people~     will receive a placebo. A placebo is a sugar pill that looks like medication but does not~     have any active ingredients in it.~      The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the~     number of migraines people who have episodic migraine get.~   "
178753|NCT01225250|"~     The purpose of this study is to determine efficacy, safety, and ease of cartilaginous~     grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as~     performed through an endonasal rhinoplasty approach in patients requiring a caudal septal~     extension (CSE) graft.~   "
178754|NCT01225237|"~     A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo~     for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate~     its safety.~   "
178758|NCT01225185|"~     Neurological injury after elective shoulder surgery in the beach chair position is thought to~     result from cerebral hypoperfusion and should therefore be preventable by appropriate~     hemodynamic monitoring and management. This proposal will use a system to continuously~     monitor cerebral blood flow autoregulation to identify safe arterial blood pressure targets~     in patients in the beach chair position, compared with a control cohort having orthopedic~     surgery in the lateral decubitus supine position. Autoregulation data will be compared~     against a new, highly specific and sensitive serum biomarker of neurologic injury, glial~     fibrillary acid protein, and postoperative neurocognitive testing results.~   "
178759|NCT01225172|"~     The purpose of this study is to evaluate oral doses of BMS-754807 in combination with~     letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic~     hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal~     aromatase inhibitor treatment.~   "
178760|NCT01225159|"~     To determine whether intraoperative tight glycaemic control can reduce postoperative~     infection, morbidity and mortality~   "
178761|NCT01225146|"~     The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg~     in patients with ischemic CRVO who have been either previously treated with ranibizumab or~     treatment naïve.~   "
178762|NCT01225133|"~     The aim of this study is to evaluate the effectiveness of a complex āyurvedic diagnosis and~     treatment compared to conventional standard care in patients with OA of the knee.~   "
178763|NCT01225120|"~     The purpose of this repeated measures design gait training study is to develop and~     quantitatively assess the effectiveness of a virtual reality training environment using~     real-time feedback for modification of pelvic motion during gait.~   "
178764|NCT01225107|"~     Bacterial infections are a common complication in patients suffering from burns. These~     infections can cause significant morbidity and often mortality. Antimicrobial resistance~     coupled with the prevalence of burn-related infections warrants the identification of~     alternative substances in the treatment of burn-related infections. The cranberry has been~     examined as a potential agent in the prevention of other types of infections and it appears~     to have anti-adherence effects on bacteria. In addition, the cranberry has demonstrated~     general inhibitory effects against some types of bacteria suggesting that it may be a useful~     agent in the prevention of bacterial infections in burn patients. The purpose of the present~     study is to investigate the effect of cranberry extract on the incidence of infections in~     burn patients.~   "
178765|NCT01225094|"~     The purpose of this program of research is to determine whether curcumin, a natural health~     product, can prevent acute kidney injury and other complications after elective AAA repair.~     If proven safe and effective, curcumin is an inexpensive intervention which can be readily~     applied to almost 50,000 AAA repairs performed worldwide each year. New knowledge about this~     intervention may also guide its use in other surgical and medical settings to prevent~     complications to the kidneys, heart and other organs.~   "
178766|NCT01225081|"~     This study is to evaluate the efficacy and safety after concomitant administration of ASP1941~     and pioglitazone in patients with diabetes mellitus.~   "
178767|NCT01225068|"~     Low back pain is a public health problem affecting between 70-85% of adults at some time in~     their life. This study is being done to study the safety and effectiveness of the drug~     Milnacipran in treating chronic low back pain.~   "
178768|NCT01225055|"~     Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the~     effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on~     bone mass.~   "
178769|NCT01225042|"~     Background:~      The incidence of gastrointestinal infections is very high. In European countries 10-25% of~     the population suffers from at least one foodborne infection per year. Probiotics may~     strengthen human resistance to gut infections as they may beneficially modulate the~     intestinal microbiota composition and activity, and the immune function upon intestinal~     infection.~      Aim:~      To study whether probiotics improve the resistance of humans to enterotoxigenic E. coli~     (ETEC).~      Study design:~      The PRETEC study is a parallel, double-blind, placebo-controled 4-weeks intervention with~     probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs~     placebo on several infection markers in response to an ETEC challenge is investigated.~     Participants will be randomly assigned to the probiotic or placebo group (n=21 per group).~     Subjects will be instructed to maintain their habitual food intake, but to standardize their~     dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally~     infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food~     research; dose will be 10E10 CFU). This ETEC strain induces mild and short-lived infectious~     diarrhea symptoms. Before and after infection, a diary will be kept to write down all food~     and drinks consumption (2x2 days) to assess the habitual dietary intake. The diary will also~     be used for daily recording of bowel habits and frequency and severity of gastrointestinal~     complaints. Blood is sampled for immune response analyses and multiple faecal samples are~     collected to quantify several infection- and immune system markers, to determine probiotic~     excretion, and to verify dietary calcium intake.~      Study population:~      Healthy males of 20-55 yrs of age.~      Interventions:~      Probiotics (freeze-dried powder, dose 10E9 CFU twice daily) or placebo (carrier material~     powder of identical appearance).~      Primary outcomes:~      Total fecal ETEC excretion per day and severity of diarrhea (quantified by faecal output per~     day).~      Secondary outcomes:~      Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal~     complaints, relative faecal wet weight, sIgA and calprotectin in faeces, probiotic~     persistence and levels of opportunistic pathogens in the endogenous microbiota.~   "
178770|NCT01225029|"~     Transient tachypnea of the newborn (TTN) is a diagnosis given to infants born between 34 and~     42 weeks gestation who develop difficulty breathing during the first days of life when no~     specific cause of the breathing difficulty can be identified. Little is known about why some~     babies develop TTN, and there have not been many formal studies of the best way to take care~     of babies with this disease. Babies with TTN get better on their own within three to five~     days after birth, but may require extra oxygen to breath well.~      Most physicians believe that the symptoms of TTN are related to poor clearance of fluid from~     the newborn's lungs. Babies with TTN have extra fluid visible on chest x-ray. Diuretics,~     medicines that can help clear extra lung fluid in adults and in babies with extra lung fluid~     for other reasons, do not to help babies with TTN. Babies with TTN need intravenous fluids to~     be healthy because they breathe too fast to be able to eat. Breastfed babies only get a very~     small amount of fluid in the first few days of life, as it normally takes several days for a~     new mother to begin producing breastmilk. No one has yet examined whether giving babies with~     TTN an amount of fluid similar to the small amount they would receive if they could~     breastfeed would help them recover from TTN faster.~      In this study, the investigators compare whether giving newborns standard intravenous fluid~     or amounts of intravenous fluid more close to what a breastfed baby would receive speeds~     recovery in newborns with TTN.~   "
178771|NCT01225016|"~     This study will evaluate thyroid nodules using specialized ultrasound imaging methods.~   "
178772|NCT01225003|"~     In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy~     (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection of~     microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in~     optimal choice and planning of treatment.~      Patients treated with gliomatous brain tumours are included voluntarily. They undergo one~     imaging session on a 3T MR scanner prior to treatment.~      DKI data are quantitively analyzed in order to estimate specific parameters in normal~     appearing white matter, grey matter, tumor and peritumoral edema. MRS data are analyzed~     quantitatively and qualitatively with peak integration, ratio calculation and classification~     algorithms. Histological confirmation is obtained at subsequent surgery.~      Information from this study can be of significant importance in avoiding brain biopsies.~     Furthermore, information on microscopic tumour spread can be used during neurosurgery or in~     radiotherapy planning. An important advantage of these advanced MR techniques is the~     non-invasivity and the lack of ionizing radiation, two important issues in this relatively~     young patient population.~   "
178773|NCT01224990|"~     The aim of the study is to assess the value of whole body diffusion weighted MR imaging~     (WB-DWI) as a non-invasive method. On one hand for pretreatment lesion detection and~     post-therapeutic tumor recurrence but also for early therapy monitoring with the intention to~     early identify patients with a poor tumor response. Our research group demonstrated that this~     technique is accurate in patients with head and neck cancer it could differentiate between~     viable tumor tissue and inflammatory or necrotic tissue at variable time points after~     completion of radiotherapy. In the literature it is stated that DWI can also predict the~     response to chemotherapeutic therapy. This is only true for focal MRI images (eg only in~     liver). This study aims to determine whether the whole body technique can efficiently be used~     because the distribution of metastases is systemic. The study includes two phases: In a first~     phase, a baseline study will be conducted; all possible injury types will be gathered to~     determine the variability in signal characteristics to finally determine appropriate~     thresholds to differentiate between benign and malignant lesions. This should allow us later~     on to perform prospective studies. In a second phase, different applications such as:~        -  pretherapeutic staging~        -  Detection of post-therapy recurrence~        -  Early evaluation of systemic cytotoxic therapy.~      The results of the DW-MRI will be compared with those of PET, CT and conventional MRI which~     are now routinely performed for the diagnosis of colorectal tumors. The scans will be~     performed in a group of patients on a 3 Tesla MR system. This system is fully approved by the~     European and American standards and the patients will not be exposed to radiation or contrast~     agents. In principle, all patients treated for gastrointestinal cancer were included after~     informed consent from the patient. This study is important to investigate whether DWI is~     accurate in the pre-therapeutic injury detection and staging of gastrointestinal tumors~     compared with PET / CT and DWI. In addition it is important to predict the outcome after~     therapy.~   "
178774|NCT01224977|"~     The main objectives of the study are:~      1. To unravel the importance of molecular phenotyping in predicting the response to~     antimicrobial therapy with potential anti-inflammatory potency~      The investigators have developed a non-invasive technique based on mRNA analysis of induced~     sputum that enables us to study airway inflammation in detail. This technique forms the basis~     for our current project based on the following hypotheses:~        1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as~          reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can~          be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.~        2. Based on our previous research and preliminary data that non-Th2 asthma can be further~          divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2,~          Th17 or Th1 characteristics also exist.~        3. These subgroups have different responses to anti-microbial therapy with potential~          anti-inflammatory potency (macrolides).~   "
178775|NCT01224964|"~     The main objectives of the study are:~      1. To unravel the importance of molecular phenotyping in predicting the response to classical~     anti-asthma treatment (leukotriene antagonists)~      The investigators have developed a non-invasive technique based on mRNA analysis of induced~     sputum that enables us to study airway inflammation in detail. This technique forms the basis~     for our current project based on the following hypotheses:~        1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as~          reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can~          be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.~        2. Based on our previous research and preliminary data that non-Th2 asthma can be further~          divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2,~          Th17 or Th1 characteristics also exist.~        3. These subgroups have different responses to anti-leukotrienes.~   "
178776|NCT01224951|"~     The main objectives of the study are:~      -to unravel the importance of molecular phenotyping in predicting the response to classical~     anti-asthma treatment (inhaled corticosteroids)~      The investigators have developed a non-invasive technique based on mRNA analysis of induced~     sputum that enables us to study airway inflammation in detail. This technique forms the basis~     for our current project based on the following hypotheses:~        1. different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as~          reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can~          be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.~        2. Based on our previous research and preliminary data that non-Th2 asthma can be further~          divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2,~          Th17 or Th1 characteristics also exist. The investigators hypothesize that the~          epithelial cell cytokine, TSLP, can be increased as an early marker of airway~          inflammation in this latter group.~        3. these subgroups have different responses to anti-inflammatory treatment.~   "
178777|NCT01224938|"~     The main objectives of the study are~        1. to study the different T cell subtypes (Th1, Th2, Th17 and Treg) in the lower airways of~          healthy subjects and clinically different asthma patients, based on a non-invasive~          procedure of sputum induction. Patients will be different in function of age, in~          relation to the trigger (eg aspirin, without or with association with polyposis),~          without or with underlying atopic sensitization or different in the type of underlying~          inflammation (eosinophilic vs neutrophilic). This T cell pattern will become the basis~          of molecular phenotyping in the patients.~        2. to study the usefulness of asthma molecular phenotyping (by following the balance~          between the inflammatory markers on the one hand and the regulatory markers on the other~          hand) in asthma guidance (longitudinally).~      The final goal of this project is then to develop a sputum non-invasive biomarker array that~     can be used to distinguish the different inflammatory asthma phenotypes and that can predict~     steroid resistance and/or sensitivity to other anti-inflammatory medication, using a~     non-invasive technique that can be used also at young age and repetitively.~   "
178778|NCT01224925|"~     The purpose of this study is to investigate whether MTA is more effective than a conventional~     calcium hydroxide liner (Dycal®) as a direct pulp capping material in mature molar teeth with~     a carious pulpal exposure.~   "
178779|NCT01224912|"~     The object of this study is to determine variables associated with therapy-success of a~     cognitive behavioral self help intervention for insomnia. In this study all participants~     receive an online self-help CBT manual consisting of information (psycho-education) about~     sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a~     popular scientific website to fill out online questionnaires. Participants will be measured~     4, 16, and 40 weeks after intervention with the same questionnaires.~   "
178780|NCT01224899|"~     The investigators sought to evaluate the feasibility and safety of surgical sympathetic~     blockade in systolic heart failure patients and secondary to assess its cardiovascular~     consequences.~   "
178781|NCT01224886|"~     Insulin resistance is a crucial factor for the development of type 2 diabetes and a major~     health problem for older adults. It is the principal mechanism by which obesity is considered~     to increase the risk for type 2 diabetes and is a key feature of the metabolic syndrome. The~     elevated prevalence of obesity and type 2 diabetes in the older population has important~     consequences on the morbidity and mortality as well as on the economic burden on society.~     Controversy currently exists as to whether or not aging contributes to insulin resistance.~     Many potential factors confound the association between aging and insulin resistance,~     including obesity and physical inactivity.~      Ectopic lipid depositions, defined as an excess accumulation of triglycerides in non adipose~     tissues such as in the liver (intrahepatic lipids) and within the muscle fibers~     (intramyocellular lipids), are positively associated with obesity and insulin resistance.~     Furthermore, the accumulation of intracellular lipids is often cited as being a key~     determinant in the underlying mechanisms of insulin resistance. In addition of playing an~     important role in obesity and type 2 diabetes, these ectopic fat depositions are also~     observed in common conditions such as aging and physical inactivity.~      The intervention trial will test in skeletal muscle, liver and heart of sedentary obese~     volunteers, normal weight volunteers and masters athletes, the overall hypotheses that~     exercise improvement of fat oxidation capacity and/or decrease of damaging fat metabolites is~     a primary factor that predicts the improvement in insulin resistance.~   "
178782|NCT01224873|"~     Breast cancer can metastasize to the bones, which leads to another treatment if bone~     metastases are detected. The purpose of the study is to determine, if fluoride PET/CT is~     superior to bone scintigraphy with technetium. On the other side, the investigators would~     like to see if FDG-PET/CT is a reliable alternative to dedicated bone imaging to detect bone~     metastases in patients with breast cancer.~   "
178783|NCT01224860|"~     In renal transplant recipients, residual renal insufficiency combined to the effects of~     immunosuppressive therapy with steroids or calcineurin inhibitors may reduce insulin activity~     and may contribute to several of the abnormalities associated with the metabolic syndrome,~     such as hypertension, glucose intolerance and hyperlipidemia. In turn, insulin resistance,~     hypertension, hyperglycemia and dyslipidemia may importantly contribute to the excess~     cardiovascular risk of renal transplant patients (an excess comparable to that of diabetes~     subjects with over diabetic nephropathy)and may also accelerate progressive renal function~     deterioration and promote graft loss. Thus, amelioration of the insulin activity and of the~     related metabolic syndrome is a key component of treatments aimed to improve patient and~     graft survival in renal transplant recipients. Recently, drugs such as peroxisome~     proliferators-activated receptor-gamma activators, that ameliorate insulin sensitivity and~     metabolic syndrome, have become available.These agents, however, can provoke fluid retention,~     weight gain, edema and, in some cases, heart failure.~      Recent studies showed that telmisartan, an angiotensin II type 1 receptor antagonist, in~     addition to block the angiotensin II type 1 - a key surface receptor involved in the~     regulation of blood pressure - may also activate peroxisome proliferators-activated~     receptor-gamma activators, thus improving some of the features of the metabolic syndrome.~     Thus telmisartan may substantially reduce the overall cardiovascular and renal risk of renal~     transplant recipients by ameliorating some of the modifiable components of the metabolic~     syndrome. On the other hand, telmisartan is devoid of the adverse effects of peroxisome~     proliferators-activated receptor-gamma activators such as fluid retention, and has therefore~     a remarkably better risk/benefit profile. Thus, whether telmisartan in addition to the~     beneficial effects of a reference angiotensin II type 1 receptor antagonist (such as~     losartan) may offer adjunctive advantages related to improved insulin sensitivity in renal~     transplant patients on chronic therapy with steroids and/or calcineurin inhibitors, is worth~     investigating.~   "
178784|NCT01224847|"~     Patients with neovascular age-related macular degeneration (AMD) scheduled to receive~     intravitreal (IVT) Ranibizumab injection will be randomized to receive one of three topical~     anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10~     seconds (2) tetracaine gtt alone and (3) cocaine gtt alone. A questionnaire will be conducted~     immediately after and 15 minutes after the injection, to assess for pain.~   "
178785|NCT01224834|"~     The purpose of this study is to determine the safety and tolerability of several doses of~     ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic~     rhinitis to ragweed.~   "
178786|NCT01224821|"~     Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry,~     dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients~     with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective~     of this study is to demonstrate that each site could accurately conduct the whole body~     dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody.~     Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of~     Iodine-131 Anti-B1 Antibody.~   "
178787|NCT01224808|"~     The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding episodes~     due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or~     abnormal Von Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term~     efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children,~     adolescents, and adults with VWD in whom treatment with a VWF product is required for~     prophylactic therapy, haemostatic control during surgery, or control of a non-surgical,~     spontaneous, or traumatic bleeding event.~   "
178788|NCT01224795|"~     This is a study to evaluate the efficacy and safety of a single dose of intravenous peramivir~     versus placebo in adolescents and adults with acute uncomplicated influenza.~   "
178789|NCT01224782|"~     The aims of this post-marketing observational study (PMOS) are to evaluate the time period~     needed to achieve > 30% decrease of intact parathyroid hormone (iPTH) compared to the initial~     values and to provide data on the tolerability and compliance of treatment with Zemplar~     (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients~     with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.~   "
178790|NCT01224769|"~     This retrospective study collects and evaluates the clinical experience reached in Italy on~     the use of bendamustine alone or combined with rituximab as treatment of patients with~     relapsed or refractory chronic lymphoproliferative disorders.~   "
178791|NCT01224756|"~     The purpose of this study is to confirm the efficacy of tinoridine hydrochloride (HCL), three~     times daily (TID), in the treatment of pain and inflammation in patients with acute~     tonsillitis and/or acute pharyngitis of nonbacterial origin versus placebo.~   "
178793|NCT01224730|"~     This is a Phase I study which will analyze any food-drug effects as well as QTc effects of~     perifosine. Safety and efficacy will also be evaluated.~      Patients who complete the first 24 days on single agent perifosine may have the opportunity~     to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine +~     perifosine; or 3) switch to the combination of sorafenib + perifosine.~   "
178794|NCT01224717|"~     This study is designed to provide information about the bone-anabolic response of PTH134 when~     administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the~     active ingredient in PTH134.~   "
178795|NCT01224704|"~     Background:~      - One area in which obese and lean individuals may be different is how their bodies handle~     water balance and thirst. Studies done in animals suggest that individuals with greater body~     fat may tolerate periods without water better than lean animals. Other research has found a~     link between the ability to tolerate periods without water and increased body weight.~     Researchers are interested in studying whether the ability to tolerate periods without water~     and ability to feel thirst might differ in lean versus obese individuals.~      Objectives:~      - To evaluate the effects of water deprivation and feelings of thirst in lean and obese~     individuals.~      Eligibility:~      - Healthy individuals at least 18 years of age who are either lean (body mass index less than~     26 kg/m(2)) or obese (body mass index at least 35 kg/m(2)).~      Design:~        -  Participants will be screened with a medical history, physical examination, and blood~          and urine tests.~        -  Participants will spend the entire study (13 days) as inpatients at the National~          Institutes of Health Clinical Center.~        -  Participants will have the following tests and procedures:~        -  Body composition assessment (using low-level x-rays) to determine the percentage of fat~          tissue in the body.~        -  Oral glucose tolerance test (similar to that often used to diagnose diabetes).~          Individuals who are suspected to have diabetes will not be allowed to continue with the~          study.~        -  High salt infusion test, in which an infusion of saline (salt water) will be given for 2~          hours and participants will respond to questions about how hungry and thirsty they feel~          during the procedure.~        -  Water deprivation test, in which participants will go for 24 hours without water or food~          and respond to questions about how hungry and thirsty they feel.~        -  24-hour stay in a metabolic chamber to determine how many calories participants burn in~          a day.~        -  A series of questionnaires about participants' eating habits, feelings about food, and~          personal feelings, as well as computer-based tests involving the performance of various~          tasks.~        -  Measurement of free-living energy using doubly-labeled water, in which participants will~          drink a sample of water with extra-heavy atoms of hydrogen and oxygen to evaluate the~          amount of water in the body.~        -  24-hour urine collection.~        -  Frequent blood samples, urine collection, and fat tissue biopsies during the various~          study procedures.~        -  After the end of the 13-day study, participants will return after 1 week for a final~          urine collection.~   "
178796|NCT01224691|"~     Background:~        -  Human respiratory syncytial virus (RSV) is a virus that causes respiratory tract~          infections, and is frequently responsible for hospital visits in infants and children.~          It can also trigger severe breathing problems for individuals who have asthma, but these~          infections are generally better tolerated in non-asthmatics. Some research suggests that~          lack of an efficient immune system response in people with asthma may make it difficult~          for the body to fight the effects of RSV.~        -  Transforming Growth Factor-beta (TGF-[beta]) is a chemical in the body that is more~          prevalent in the lungs of people with asthma and related respiratory disorders. More~          information is needed about the effects of TGF-[beta] and whether it makes individuals~          with asthma more prone to developing RSV. Researchers hope to use this information to~          determine possible treatments and therapies for individuals with asthma who contract~          RSV.~      Objectives:~      - To determine the possible role of TGF-[beta] in increased asthmatic susceptibility to RSV~     infection.~      Eligibility:~      - Individuals between 18 and 60 years of age who are either healthy nonsmokers or mild~     asthmatics.~      Design:~        -  This study involves a screening visit and a study visit.~        -  Participants will be screened with a medical history and physical examination, as well~          as blood samples and a pulmonary function test.~        -  At the study visit, participants will receive mild anesthetic and have a bronchoscopy,~          in which researchers insert a bronchoscope through the participant s nose or mouth and~          into the lungs to examine the lungs and collect lung cells.~        -  Participants will be contacted by a research team member 24 36 hours after the~          bronchoscopy to ask about any side effects from the procedure.~   "
178797|NCT01224678|"~     RATIONALE: Vitamin D may help prevent breast cancer.~      PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in~     female patients.~   "
178798|NCT01224665|"~     RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in~     patients with invasive bladder cancer. It is not yet known whether extended pelvic~     lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.~      PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see~     how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing~     surgery for invasive bladder cancer.~   "
178799|NCT01224652|"~     The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy~     with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients~     with recurrent and metastatic gastric cancer who progress following first line therapy.~   "
178800|NCT01224639|"~     The purpose of this study is to assess the safety of Takeda's Tetravalent Dengue Vaccine~     Candidate (TDV) (previously DENVax) in healthy adults when given as either a subcutaneous~     (SC) or intradermal (ID) injection at two dose levels (low and high). The vaccine will be~     given as two doses 90 days apart. Safety assessments include injection site evaluation and~     adverse events. The immune response generated after vaccination will be assessed up to 9~     months after the first vaccination.~   "
178801|NCT01224626|"~     To collect the efficacy and safety information in subjects who have been treated with Zyvox~     (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate~     use in daily practice.~   "
178802|NCT01224613|"~     The purpose of this study is to compare the immunogenicity and reactogenicity of~     self-administered intradermal influenza vaccine (Intanza)to nurse-administered.~   "
178803|NCT01224600|"~     The purpose of this study is to determine the prevalence and risk factors, at the time of the~     diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.~   "
178804|NCT01224587|"~     The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix~     placebo tablets in healthy male volunteers under fasting and fed conditions. The method which~     is used is an imaging technique.~   "
178805|NCT01224574|"~     The primary aim of the study was to assess whether D-Dimer level at entry or an increase of~     D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular~     events in patients with atrial fibrillation.~   "
178806|NCT01224561|"~     For a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to~     nutrient intakes. This adaptation to nutrition may be impaired in susceptible individuals or~     in obese patients by promoting weight gain, either in constitutional thinness (MC) by~     blocking it. The MC is a little known entity. These patients wish to grow for her and others.~     Can they? We have demonstrated abnormalities of hormones regulating appetite (ghrelin, PYY,~     GLP1 and leptin) that may participate in thinness. Furthermore, this thinness is associated~     with osteoporosis in 25% of true MC who is 25 years old.~   "
178819|NCT01224392|"~     The investigators propose a randomized non-inferiority trial that compares preoperative~     Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated~     boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential~     with regard to toxicity and cost. The metabolic response of the tumor, as assessed by~     18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be~     used as a surrogate marker of cause specific outcome~   "
178807|NCT01224548|"~     The purpose of this study is to study the potential benefits of low fat vegan diet in a~     randomized, controlled and multi-centered workplace setting, the investigators will enroll~     participants from 10 worksites of Government Employee Insurance Company (GEICO). After~     randomization, 5 will be the vegan sites and 5 will be the control sites for 10 month study.~     The vegan sites will receive low fat vegan diet instructions and weekly group sessions~     starting from year 1. no intervention is done to the control sites until the week 18 when the~     identical program will be given. At various time points, health measurements will be give to~     all participants.~   "
178808|NCT01224535|"~     Introduction: Iron deficiency anaemia remains a significant public health challenge.~     Localized food based approaches may offer a large opportunity to improve lives and address~     the widespread micronutrient deficiencies such as iron in affected households. Viable~     solutions where iron rich foods are not readily available may come through diversification~     approaches using foods such as amaranth grain reported to contain high iron content and good~     quality protein in conjunction with the use of in-home fortification.~      Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on~     improving diet quality, iron intake and status in children 12-59 months in a semiarid area in~     Kenya.~      Study population: The study population will comprise children aged 12-59 months in Migwani,~     within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed~     on behalf of the children. In total, 270 children will be enrolled in the study.~      Study design:~      The study has a randomized controlled trial design conducted over a period of 4 months/16~     weeks.~      Treatment/hypothesis: All participating children will be required to take the provided~     porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments~     groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30~     maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder~     (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant~     difference in hemoglobin and iron status between the three groups.~      Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after~     intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be~     assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive~     protein (CRP) will be done at the participating laboratories.~      Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this~     study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are~     the secondary outcome. Iron deficiency will be defined as SF concentration <12 µg/L and~     tissue iron deficiency will be defined as serum transferrin receptor concentration of~     >8.3mg/L. Infection will be assessed by raised CRP (>10mg/L) as an indicator of acute~     inflammation and presence of malaria.~   "
178809|NCT01224522|"~     - Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL~     TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION~        -  Short Title: Visionaire Alignment~        -  Methodology: Monocentric, Single Blinded, Randomized Controlled Trial~        -  Study Duration: November 2010 to July 2014~        -  Study Centres: Leicester General Hospital, United Kingdom (UK)~   "
178810|NCT01224509|"~     The purpose of this study is to determine the effect of mifepristone on the expression of~     three cervical EP3 receptor isoforms (EP3-2, EP3-3 and EP3-6) in pregnant women ≤63 days~     gestational age.~   "
178811|NCT01224496|"~     The purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on~     anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS),~     aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did~     not respond to available treatment options.~   "
178812|NCT01224483|"~     Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which~     unregulated activation of the complement system leads to significant ischemic morbidities~     with shortened lifespan. Life-threatening thromboembolism (TE) is the most feared~     complication of PNH, accounting for up to 45% of patient deaths. It is estimated that 40% of~     PNH patients experience a clinically evident TE and 60% of patients without clinically~     diagnosed TE demonstrate TE by high-sensitivity MRI, indicating the ongoing thrombotic risk~     in most patients with PNH. Much of these data come from PNH patients from European descent.~     To understand the impact of TE in patients with PNH from non-European regions, we performed~     this study to evaluate the clinical characteristics of Korean patients with PNH.~   "
178813|NCT01224470|"~     Dexmedetomidine is a new selective and potent alpha-2 agonist. It has centrally acting~     anesthetic properties. It has been known that intrathecal addition of alpha-2 adrenergic~     agents result in prolongation of the duration of the sensory and motor blockade induced by~     hyperbaric bupivacaine. But the effects of intravenous dexmedetomidine on the spinal block~     was not evaluated. The aim of study is to assess the effect of intravenous dexmedetomidine on~     the low-dose spinal anesthesia for the transurethral surgery.~   "
178814|NCT01224457|"~     The pharmacogenomic profiles of drug metabolizing enzymes play an important role in~     pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure, is~     a drug that requires careful dose adjustments based on therapeutic drug monitoring. It was~     reported that phenobarbital (PB) metabolism was affected by CYP2C9 and CYP2C19 polymorphisms~     in adults. This study aims to evaluate the effects of the CYP2C9 and CYP2C19 genetic~     polymorphisms on PB PK in infants with neonatal seizure for an optimal dosing strategy.~   "
178815|NCT01224444|"~     Colorectal cancer is the second most common cause of cancer death in the US. Colonoscopy is~     considered the best test colorectal cancer screening. It allows resection of adenomatous~     polyps (a known cancer precursor) and thus, interrupt the adenoma-carcinoma sequence. Despite~     the potential benefit of screening colonoscopy recent studies have reported cases of~     colorectal cancers in a short interval after prior screening or surveillance colonoscopies.~     One possible cause of such interval cancers may be incomplete resection of adenomatous polyps~     and hence ongoing growth and cancer development in such lesions. Complete resection may be~     particularly important for polyps of at least 5mm in size as up 10% of such polyps higher~     risk lesions as villous adenoma, tubulovillous adenoma, high grade dysplasia, or early~     carcinoma.~      Although adenoma resection of sessile and flat adenomatous polyps between 5 and 20mm is~     believed to be well standardized data on complete resection of adenomatous tissue are sparse.~     This may be related to the assumption that using a snare with electro-cautery will~     successfully remove the polyp and cauterize remaining marginal adenomatous tissue and hence~     completely remove and or destroy the lesion.~      The investigators are interested in examining how often sessile adenomatous polyps between 5~     and 20mm are completely removed using standard polypectomy snare. The investigation was also~     directed at a comparison between complete resection of polyps between 5 and 9mm and 10 and~     20mm.~   "
178816|NCT01224431|"~     Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered~     lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing~     pain prior to lumbar puncture in infants.~      Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3~     months of age, presenting to the emergency department meeting clinical criteria for a lumbar~     puncture. All patients were administered the J-tip and randomized to either treatment with 1%~     lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.~   "
178823|NCT01224340|"~     The hypothesis was that an active distraction is more effective than a passive distraction in~     conjunction with procedural pain in children. The specific aim in this study was to test how~     an active distraction, serious gaming and a passive distraction, the use of lollipops~     influence pain, distress and anxiety in children during wound care.~   "
178824|NCT01224327|"~     The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem~     cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.~   "
178825|NCT01224314|"~     In a study published in 1995 in the American Journal of Kidney Diseases, Dolson et al~     demonstrated that a rapid decrease of serum potassium concentrations during haemodialysis~     would produce a significant increase in systolic blood pressure at the end of the session,~     even though there were no clear effects on intra-dialytic blood pressure. The authors defined~     this post-dialysis blood pressure behaviour as rebound hypertension. Paradoxically, in~     animal models, other than in the context of end-stage renal disease, potassium is a~     vasodilator. Considering that the removal of potassium during the haemodialysis session could~     be theoretically modulated in profiles (as with sodium and bicarbonate), it was deemed~     suitable to delve deeper into this argument by studying, in detail, the (non invasive)~     hemodynamic repercussions of changes in the potassium concentration of the dialysate. Not~     being able to linearly modify the concentration, we decided to divide the dialysis session in~     3 tertiles, randomising the patients to all possible dialysate sequences containing the usual~     concentration of potassium or two cut-off points at +1 and -1 mmol/l. Haemodynamic~     measurements were performed using a finger beat-to-beat monitor.~   "
178826|NCT01224301|"~     Purpose of the study. The purpose of the project is to evaluate the feasibility,~     acceptability, and cost effectiveness of providing influenza vaccine in schools to children~     in grades Kindergarten through 6th grade.~      Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of~     influenza vaccination in school children.~      Hypothesis 2: Higher intensity parent notification about school based influenza vaccination~     does not increase immunization rates compared to low intensity.~      Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost~     neutral.~   "
178827|NCT01224288|"~     This is a companion protocol to MD Anderson Cancer Center study 2010-0085 (Sequential Therapy~     in Advanced Renal Cell Carcinoma Therapy: The START Trial).~      The goal of this clinical research study is to learn if dynamic contrast enhanced computed~     tomography (DCE-CT) scans can help researchers learn if the study drug received as part of~     study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.~   "
178828|NCT01224275|"~     The Study compares group based care versus individual given care-effects on patient~     satisfaction and health. Midwives will be randomized to either traditional antenatal care~     (Individual care) or group based antenatal care(intervention).~   "
178829|NCT01224262|"~     This study is designed to evaluate the safety, tolerability, and immune response of LIQ001~     mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations~     of subjects; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65~     years of age or older.~   "
178830|NCT01224249|"~     The primary aim of this study is to investigate, whether higher intake of selenium rich food~     items such as fish and shellfish, is associated with higher selenium blood levels.~      The secondary aim is to investigate the uptake of selenium from fish and shellfish and the~     incorporation of selenium from those foods into proteins in the human body. Furthermore, the~     impact of the natural variation in the genes that are responsible for the accumulation of~     selenium in the proteins will be investigated.~   "
178831|NCT01224236|"~     The purpose of this study is to determine if iron supplementation in addition to routine iron~     intake decreases the risk of developing anemia in preterm infants.~   "
178832|NCT01224223|"~     Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T~     cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to~     chronic inflammatory conditions such as cancer, leading to the induction of tolerance and,~     ultimately, tumor escape from immune surveillance.~   "
178833|NCT01224210|"~     This is an Open Label, Multicenter, pilot clinical trial to assess the efficacy and safety of~     an oral selective Endothelin Receptor Antagonist (ambrisentan) in patients with~     portopulmonary hypertension.~      Preliminary evidence suggests that ambrisentan is safe and effective in patients with~     portopulmonary hypertension. The goal of therapy for these patients is to improve symptoms of~     dyspnea and to improve pulmonary hemodynamics to a mean pulmonary artery pressure <35 mm Hg~     in order to make patients eligible for liver transplantation. Therefore, the primary~     endpoints for this study will include 6 minute walk distance (6MWD) and pulmonary vascular~     resistance (PVR).~      Eligible subjects will receive 5 mg ambrisentan once-daily for the first 4 weeks. After the~     initial 4-week period, investigators will increase study drug dose to 10 mg once daily (both~     5 mg and 10 mg doses are FDA approved). If 10 mg is not tolerated in the opinion of~     investigator, then the investigator may decrease the dose back to 5 mg once daily. Primary~     outcome is a change in both the 6MWD and in PVR from baseline to Week 24. Subjects will be~     monitored with liver function tests (LFT) every 2 weeks for the first 8 weeks, then every 4~     weeks thereafter. These safety laboratory tests may be performed at a local phlebotomy~     laboratory or at the Investigator clinic. In addition, the Investigator will assess each~     subject for safety and efficacy at Week 4, Week 12, and Week 24. Following Week 24, subjects~     will be assessed for safety and efficacy every 12 weeks. Patients will be followed for a~     total of 1 year. After 1 year, if the Investigator feels that continuing the treatment will~     be beneficial to the patients, they will be provided with ambrisentan by Gilead~     Pharmaceuticals, free of charge.~   "
178834|NCT01224197|"~     The purpose of this study is to assess the pharmacokinetics, safety and tolerability of~     single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK)~     means how the drug is absorbed into the bloodstream, distributed in the body and eliminated~     from the body.~   "
178835|NCT01224184|"~     The purpose of this study is to test the efficacy of a cultural-, age- and gender-focused~     Human Immunodeficiency Virus (HIV) prevention intervention in reducing risk behaviors among~     African-American young women relative to general health intervention.~   "
178836|NCT01224171|"~     This study in patients with moderately to severely active Crohn's disease is designed to~     establish the efficacy and safety of vedolizumab for the induction of clinical response and~     remission.~   "
178838|NCT01224132|"~     This study was designed to evaluate the efficacy of probiotics in the treatment of atopic~     dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not~     effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum~     total and specific IgE levels.~   "
178839|NCT01224119|"~     The current research study evaluates an investigational medical device called Amplex B2A(TM)~     Peptide Enhanced Ceramic Granules (Amplex) for use in foot and ankle fusion. Amplex is a~     synthetic bone graft material. The most frequently used graft material is bone collected from~     the patient (autograft). Autograft involves a secondary incision with the risks of infection~     and lasting pain.~      The purpose of this study is to determine if Amplex is a safe and effective alternative to~     autograft.~   "
178840|NCT01224106|"~     This multi-center, randomized, double-blind, placebo-controlled parallel-group study will~     evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety~     and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be~     randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo.~     Participants who consent to be part of the sub study will undergo positron emission~     tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is~     104 weeks, with an option for an additional 2 years of treatment.~   "
178841|NCT01224093|"~     This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab)~     in combination with chemotherapy in patients with previously untreated or relapsed/refractory~     B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for~     6-12 months, depending on the prescribed chemotherapy regimen.~   "
178842|NCT01224080|"~     A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked~     with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can~     harm the tubes and uterus making implantation more difficult or harm the embryo.~   "
178843|NCT01224067|"~     This is a 16-week research study in which participants suffering from Social Anxiety Disorder~     (SAD) will receive Sertraline (a medication FDA approved for the treatment of SAD) for the~     first 8 weeks. If a participant remains symptomatic, he/she will enter the second phase of~     the study in which he/she continues taking Sertraline but also randomly receives either~     Seroquel or placebo in conjunction with Sertraline for additional 8 weeks. The purpose of~     this study is to determine the efficacy of adjunctive Seroquel in treating SAD.~   "
178844|NCT01224054|"~     The worldwide epidemic of overweight and obesity affects about 1.7 billion people around the~     world. Since 1991, many international medical societies have established as recommendation~     for bariatric surgery the unsuccessful clinical treatment in patients with IMC > 40Kg/m2 or~     IMC > 35Kg/m2 in the cases with serious co-morbidities related to the possible reversion of~     them with the lose of weight due to the surgery. In front of the new anatomical condition~     from the gastrointestinal tract the patients present changes in food preferences and in the~     food intake, which include modifications in food choices, perception of hungry and satiety~     and in the tolerance to determinate food. These changes in food intake of the patients are~     observed mostly in the first year after the surgery an adaptive phase to a new condition.~   "
178845|NCT01224041|"~     This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid~     Arthritis patients who showed unsuccessful response against methotrexate.~   "
178846|NCT01224028|"~     This study is to evaluate efficacy and safety of tacrolimus in the patients with~     non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with~     tacrolimus (Prograf) or placebo.~   "
178847|NCT01224015|"~     This study will evaluate the safety and efficacy of botulinum toxin type A compared to~     placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients~     who successfully completed Study 191622-099.~   "
178848|NCT01224002|"~     The prevalence and severity of dental caries in incarcerated people who abuse drugs are~     unknown but an inmate reporting to the dental clinic typically presents with myriad findings:~     oral signs of uncontrolled decay on the buccal smooth surfaces of the posterior teeth and~     interproximal surfaces of the anterior teeth, excessive tooth wear due to grinding and~     clenching, and gingival inflammation. The primary risk factors for the development of caries~     appear to be the combination of xerostomia, frequent consumption of carbonated soft drinks,~     high dental plaque levels and nonexistent or inadequate oral hygiene. Since some of these~     findings are seen in the other disease states, specifically in substance abuse cases, the~     diagnosis is often not clear. The objective of the project is to design a cross sectional~     comparative feasibility study that will estimate the prevalence, pattern, and severity of~     untreated dental decay for three types of inmates: methamphetamine abusers, substance abusers~     not identified as methamphetamine users, and non-substance abusers, focusing in on~     methamphetamine abusers as the highest risk group.~      Recruitment will be accomplished using a 2-phased process. Phase I. An invitation letter~     explaining the study purpose and its relevance to oral health in a correctional setting will~     be mailed to the inmate population at two Federal Bureau of Prisons' institutions who entered~     the prison system during the first half of 2009. Dublin, a female FCI located in Northern~     California and Butner, a male FCC located in North Carolina were the selected facilities due~     to the high incidence of drug abusers among their inmates. The letter, which will invite all~     inmates to participate in the study, will inform the inmate should they consent to~     participate in the study that they will have their existing dental record confirmed, Central~     File reviewed for DSM-IV diagnosis pertinent to the study, and that they will be given a~     study questionnaire. Positive responses to the invitation letters will be returned to Dr.~     Johnson at head quarters in Washington DC. The psychology division will code the volunteer~     inmates into the three study groups.~      Phase II. The first 30 chronologically documented volunteers in each study group category~     will be scheduled an appointment. A consent form will be read and explained to each inmate,~     in either English or Spanish as appropriate and his/her signature obtained as his/her~     informed consent.~      Each question on the study questionnaire will be read to the inmate volunteer and the~     Research Associate will record the answer. A retrospective comparative study will then be~     employed utilizing the inmate's initial dental intake exam (routinely administered by the~     Federal Bureau of Prisons' dental department). The dental chart will be abstracted for dental~     caries. The pattern of surface-specific dental caries (DFS index) will be described and~     analyzed. The focus will be on the levels of untreated and treated disease diagnosed in a~     4-zone partition of the oral dentition, representing a modification of the zones identified~     in the Grainger's caries severity index scoring system as this partition allows focus on~     decay patterns of anterior tooth surfaces. The multivariate summary of disease levels within~     each zone will be derived and statistically compared across the three study groups using~     Hotelling's t2-test (the multivariate extension of the Student-t test). The results of the~     study will be used to do a preliminary assessment between methamphetamine drug abuse and oral~     health and determine whether a prospective clinical study is warranted.~   "
178849|NCT01223989|"~     The purpose of this study is to determine the utility of an hypocaloric diet with or without~     bread in patients with overweight and obesity~   "
178850|NCT01223976|"~     The purpose of this study is to determine the level of agreement between QuantiFeron -TB Gold~     test (QFT-G)and Tubeculin skin test (TST)for screening of latent tuberculosis in patients~     suffering from psoriasis.~   "
178851|NCT01223963|"~     This is a retrospective, multicenter chart review of medical records on the use of Macrolane~     for female breast enhancement.~      The primary objective is to evaluate the safety profile of Macrolane Volume Restoration~     Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement~     in clinical practice.~   "
178852|NCT01223950|"~     To research the prevalence and nature of DRP (Drug Related Problems) associated~     hospitalizations (hospitalizations due to problems\adverse effects of the medication~     treatment) .~      Analyzing the main reasons for DRP associated E.R admissions\hospitalizations. identifying~     drug involved and percentage of DRP associated hospitalizations.~      Monitoring the length of DRP associated hospitalizations. Evaluating LOS to hospitalized.~     Financial and other aspects will be measured.~   "
178853|NCT01223937|"~     A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to~     investigate the safety and efficacy of desmopressin oral melt tablets against placebo during~     3 months of treatment in adult females with nocturia.~   "
178854|NCT01223924|"~     This is a randomized double-blinded placebo-controlled，single-dose escalation trial in~     healthy volunteer.~   "
178855|NCT01223911|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the~     body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).~   "
178856|NCT01223898|"~     This study will evaluate the effects of multiple doses of nilotinib on the pharmacokinetics~     and metabolism of midazolam (as a sensitive CYP3A probe) in CML patients. The following~     extension study does evaluate the safety of nilotinib.~   "
178857|NCT01223885|"~     By performing a challenge with camel's milk in patients who are allergic to cow's milk, the~     investigators will examine if camel's milk is a safe alternative for these patients.~   "
178858|NCT01223872|"~     This two-part research study will compare childhood cancer survivors receiving specialized~     follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up~     care.~   "
178859|NCT01223859|"~     Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in~     the treatment of habitual snoring. The decision making process in the management of habitual~     snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to~     investigate the correlation of systematic clinical pretreatment oropharyngeal examination~     scores with the efficacy of interstitial RF surgery of SP in a multi-center study~   "
178860|NCT01223833|"~     The Logribmet study is a prospective study that evaluate grip strength changes in both hands~     of postmenopausal women with breast cancer receiving treatment with tamoxifen or an aromatase~     inhibitor. Patients included in the study will undergo a grip strength measurement and~     receive a rheumatological questionnaire prior to the start of treatment, then at 3 and 6~     months and at year 1 into therapy. Furthermore, BMI will be measured to assess if BMI is a~     predictor for the decrease in grip strength.~      IGF-I, GH and IGFBP-3 serum levels will also be measured at all time points.~   "
178861|NCT01223820|"~     The term idiopathic rhinitis (IR) is used in this study to describe a patient group with~     following characteristics: patients with complaints of nasal obstruction, sneezing and/or~     rhinorrhea for a period of over 1 year, which cannot be attributed to allergy, nasal or~     paranasal infection, anatomical disorders, pregnancy or lactation and/or systemic disorders.~     These patients are non-smokers and do not use medication affecting nasal function. They have~     no beneficial effect of intranasal steroid spray (INS) treatment.~      The population incidence of IR is estimated to be as high as 10%. The pathophysiology of IR~     is largely unknown. Several hypotheses have been put forward. In general it is assumed that~     neurogenic mechanisms play an important role. Neuropeptides like CGRP, SP, NKA/B, NPY, NGF~     are released from afferent neurons in the nasal mucosa after activation by unspecific stimuli~     and can be responsible for the symptoms of IR.~      For this group of IR-patients, there is until now only one treatment option: intranasal~     capsaicin application. Capsaicin, the pungent agent in hot pepper, is supposed to exert its'~     therapeutic effect via degeneration or desensitization effect on the afferent C-fibers.~      The hypothesis is that nasal capsaicin treatment reduces neurogenic inflammation and reduces~     in that way nasal symptoms.~   "
178862|NCT01223807|"~     Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients~     with chronic obstructive pulmonary disease (COPD). Several studies have described an~     impairment in diaphragmatic mobility of COPD patients compared to age matched control~     subjects and it has been associated with increase in dyspnea, exercise intolerance and~     mortality. COPD patients also experiment a higher activity of the accessory breathing~     muscles, which greatly increases the work of breathing and dyspnea sensation.~      Breathing strategies have been considered an important component of pulmonary rehabilitation~     and refer to a range of techniques, including/which includes the diaphragmatic breathing~     (DB). The principal aim of DB is to improve the participation of the abdominal motion while~     reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality~     in the rehabilitation of COPD patients remains controversial. Despite the conflicting~     results, improvement of the abdominal motion and a reduction of thoracic excursion, during~     voluntarily DB, has been described as a common finding of several studies. The investigators~     hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this~     modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL.~     Therefore, in this randomized controlled trial the investigators aimed to test the effects of~     a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility,~     dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.~   "
178863|NCT01223794|"~     Goals and future prospects:~        1. To finish the survey of the high risk factor ratios and high incidence rates associated~          with falls among inpatient fallers.~        2. To investigate the risk factors associated with falls and the consequential analysis~          related to falls among inpatient fallers.~        3. A good precautionary measure of falls will reduce damages and injuries for the fallers,~          especially inpatients welfare. Our accomplishments of this research proposal will~          provide sufficient information and reference for the precautionary strategies associated~          with fall incidents. More importantly, the experiences and results will be further~          explored and shared among all other hospitals.~   "
178864|NCT01223781|"~     Objective/Rationale:~      The investigators objective is to demonstrate that an intervention program based on motor~     learning principles can be applied to train subjects with Parkinson's disease (PD) who suffer~     from freezing to walk in a way that minimizes the occurrence of freezing. Since sufficient~     motor learning capabilities are preserved in PD, the investigators hypothesize that an~     intervention program that targets the time periods just prior to an approaching freezing~     episode can modify the walking strategies so that the episode will now be averted.~      Project Description:~      The freezing burden will be quantified in subjects with PD before and after 6 weeks of~     training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop~     group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking~     courses aimed at provoking freezing episodes. The experimenter will trigger an auditory~     rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning)~     and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep~     the walking pace and coordination and, as a result, to avoid freezing. Similar principles~     will apply for the CLG training; however, the RAS will be elicited automatically by a device~     that recognizes an approaching freezing episode.~      Relevance to Diagnosis/Treatment of Parkinson's Disease:~      If even partially successful, the investigators will show, for the first time that freezing~     of gait is amenable to motor learning and that appropriate training with external cueing can~     alleviate these motor blockades. While future studies will be needed to further assess~     long-term efficacy and other important questions about clinical efficacy and the mechanisms~     involved, this study should go a long way towards improving the investigators understanding~     of freezing of gait and its amenability to appropriate therapy.~      Anticipated Outcome:~      The investigators anticipate that after intensive training, the central nervous system (CNS)~     of subjects with PD will be able to anticipate impending freezing episodes based on awareness~     of the environmental conditions (e.g., an approaching turn) and/or based on sub-conscious~     response to a deteriorating gait pattern. As a result, an automated motor response that paces~     and coordinates gait will be internally triggered by the CNS and the approaching freezing~     episode will be averted. The overall freezing burden will therefore decrease in trained~     subjects.~   "
178865|NCT01223768|"~     To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy~     (grade 3 of the West Haven grading scale), we performed a randomised, double blind~     placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on~     ammonia levels and performance in cognitive functions.~   "
178866|NCT01223755|"~     The general aim of this study in adult patients with Autosomal Dominant Polycystic Kidney~     Disease (ADPKD) and severe renal insufficiency is to assess the safety and the efficacy of~     sirolimus (SRL) in slowing renal function decline as compared to conventional therapy.~   "
178867|NCT01223742|"~     The aim of this study was to evaluate the effect of exogenous ALC on the both physical and~     mental fatigue in mild and moderate encephalopatic patients.~   "
178868|NCT01223729|"~     Minimal hepatic encephalopathy represents a common complication present in well-compensated~     cirrhotic patients that impairs patients daily functioning and health-related quality of~     life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and cognitive~     functions in cirrhotic patients with minimal hepatic encephalopathy. This study evaluated the~     effects of acetyl-L-carnitine treatment on health related quality of life and on depression~     in patients with minimal hepatic encephalopathy.~   "
178869|NCT01223716|"~     Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of~     vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This~     study uses psychophysical measures to study neural plasticity in adults with amblyopia.~   "
178870|NCT01223703|"~     The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular~     systolic function in patients with stable chronic HF secondary to nonischemic dilated~     cardiomyopathy (NICM).~   "
178871|NCT01223690|"~     The herein protocol is based on the results of one former clinical trial conducted by our~     study group showing the considerable efficacy of intravenously administered clarithromycin as~     an adjuvant to antimicrobial chemotherapy for patients with sepsis, septic shock and~     respiratory failure in the field of ventilator-associated pneumonia. The proposed clinical~     trial is based on the need to generalize the application of intravenous clarithromycin in the~     total of admitted septic patients irrespective of the underlying cause of sepsis.~   "
178872|NCT01223677|"~     Depression and anxiety disorders are highly prevalent and associated with reduced quality of~     life for patients and enormous economic costs for society. Although effective treatments are~     available, a substantial number of patients fail to respond, and the time between disorder~     onset and treatment is typically long. The development of prevention programs therefore~     appears promising. The current project aims to prevent depression and anxiety by targeting~     excessive levels of worry and rumination, two important risk factors for emotional disorders.~     Participants will be selected on the basis of a high score on two validated questionnaires on~     worry and rumination. They will be randomly assigned to a rumination-focused~     cognitive-behavioral training delivered in a group format, a rumination-focused~     cognitive-behavioral training delivered via internet, or a no-training control condition. It~     is expected that both versions of the rumination-focused training will reduce symptoms of~     depression and anxiety, will reduce the incidence of major depressive episodes and~     generalized anxiety disorder, and will reduce symptom levels of other emotional disorders.~   "
178873|NCT01223664|"~     The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow~     stem cells (BMSCs) transplantation in patients with liver cirrhosis. The evaluation of the~     efficacy includes the level of serum alanine aminotransferase (ALT), aspartate~     aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB),~     prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver~     histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores~     and clinical symptoms were also observed simultaneously.~   "
178874|NCT01223651|"~     10 healthy volunteers will undergo the controlled lowering of their blood glucose level at~     sea level and a simulated altitude of 8,000 feet, to test the hypothesis that continuous~     glucose monitoring system measurement of blood glucose is as accurate at altitude as at sea~     level.~   "
178875|NCT01223638|"~     Congenital hypothyroidism (CH) occurs in 1:4000 live births. Neurological disturbances like~     speech delay, motor delay and lower IQ were reported in children with CH. Evidence from~     animal experiments indicate that CH is associated with high frequency of deafness.~     Morphological changes of the external and internal cholera hairs were reported in mutagenic~     mice with CH. Anatomical changes of the internal ear and low hearing threshold were reported~     in mice bearing Dual oxidase 2 (Duox2) gene mutations, which is responsible of oxidation of~     iodide. Knockout of Pax8 gene in mice resulted in both agenesis of thyroid gland and~     deafness. Early L-thyroxin therapy prevented the development of deafness in those mice. The~     expression of thyroid receptor α (TRα) in the external and internal cholera hairs in mice~     indicates that the thyroid hormones have an important role in the development of the internal~     ear.~      The etiology of deafness in human is both genetic and environmental. The prevalence of~     deafness in live births is 1:1000 and among them 60% is genetic. Connexin 26 gene mutations~     are the most common cause of inherited deafness and account for about 40% of the genetic~     cases. In two conditions in human the coexistence of hypothyroidism and deafness were~     reported; Pendred syndrome and thyroid hormone resistance syndrome.~      The prevalence of hearing loss in human with CH was explored in only few studies and the~     results are contrary.~      The aim of the current study is to study the prevalence of hearing loss among children with~     CH and to compare the clinical, biochemical and genetic characteristics between subjects with~     hearing loss to those without hearing loss.~   "
178876|NCT01223625|"~     The aim of this study was to measure the effect of moderate and intensive lipid-lowering~     treatment with rosuvastatin on the endothelial function.~   "
178877|NCT01223612|"~     This exploratory study will compare the effects of ranibizumab treatment with conventional~     macular laser therapy for patients with diabetic macular oedema.~      The study hypothesises that treatment with ranibizumab may be superior to laser treatment in~     terms of improving vision and decreasing retinal thickness.~      Patients will be randomised to receive either repeated injections of ranibizumab every 4~     weeks for 48 weeks or macular laser therapy every 12 weeks for 48 weeks.~      At baseline, and then at 12, 24 and 48 weeks, patients will undergo detailed testing to~     provide information on the structure and function of the retina with both of these~     treatments.~   "
178878|NCT01223599|"~     To evaluate and compare between excision with primary closure of wound and excision with~     Rhomboid flap reconstruction in the treatment of pilonidal sinus as regard duration of~     operation, healing time, hospital stay, complications and recurrence rate.~   "
178879|NCT01223586|"~     The objective of this study is to verify the relationship between coronary plaque regression~     and cardiovascular prevention in long term follow up of the Japan Assessment of Pitavastatin~     and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) study [NCT00242944]. In addition, the~     effect of serum lipid levels or different type of statins on cardiovascular prevention will~     also be examined.~   "
178904|NCT01223222|"~     The purpose of this study is to evaluate the safety and tolerability of Lytixar™ applied~     topically to uncomplicated skin infections.~      Three dose levels of Lytixar™ (1%, 2% and 5%) versus placebo will be tested.~   "
178880|NCT01223573|"~     Apgar score is a subjective measure to assess prognosis and future outcome of a newborn.~     Pulse oximetry taken at 1, 5 and 10 minutes will be correlated to apgar scores in respective~     times in an goal to assess the usability of pulse oximetry as an added tool in determining~     the newborn prognosis~   "
178881|NCT01223560|"~     The aim of this clinical study was to obtain type 1 diabetes data to identify models for~     glucose prediction and control and to construct a physiological~     pharmaco-kinetic/pharmaco-dynamic computer model of a type 1 diabetic person.~   "
178882|NCT01223547|"~     The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients~     with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that~     the metabolic control can be further improved with concurrent use of an integrated glucose~     meter and bolus calculator. The investigators want to test the hypothesis in this study.~   "
178883|NCT01223534|"~     Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB Gold~     In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study will~     allow avoiding unnecessary preventive treatment without increasing rates of tuberculosis~     cases among contacts screened.~      Aim of the study: to compare a combined strategy of the TST and the QFT-IT with TST alone for~     the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing~     study.~      Design and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.~      Study population: 870 subjects, household contacts of patients with culture positive~     pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: Arm A~     (standard practice), in which treatment decisions will be based on the TST result, and Arm B~     (experimental), in which treatment decisions will be based on the QFT result.~      Interventions: participants in arm A will undergo TST; participants in arm B will undergo~     TST, and, in case of a positive result, QFT-IT as well. Participants with positive TST (arm~     A) and positive QFT-IT (arm B) will be diagnosed with tuberculosis infection and will be~     treated with isoniazid for 6 months. All participants will be followed for two years.~      End-points of evaluation: development of tuberculosis and proportion of subjects for whom~     treatment is prescribed in each arm.~   "
178884|NCT01223521|"~     A randomized prospective study on the effects of immediate provision of intrauterine~     contraception after first trimester induced abortion - effects on repeat abortions and~     quality of life.~   "
178885|NCT01223482|"~     Studies have shown that a majority of pregnancies that end in miscarriage are due to a~     chromosome abnormality usually involving a duplicated or missing chromosome. Often this~     happens by chance and is not likely to occur in future pregnancies. For many women, a~     miscarriage can be a traumatic experience and can cause feelings of loss and grief. The~     option of genetic testing, such as karyotyping, may offer an explanation for the miscarriage~     and may help some women find closure in their loss. However, no literature exists on a~     women's experience with genetic testing following a miscarriage. This assumption that the~     knowledge that can be gained from karyotyping may be a positive experience for a woman~     following a miscarriage should be studied and the results published. This study will address~     whether routine karyotyping should be offered following a miscarriage for the purpose of~     benefiting the patient's experience.~   "
178886|NCT01223469|"~     The main objective of this study is to demonstrate the clinical safety of a contact force~     sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and~     atrial fibrillation. In addition, the study will characterize the use and value of contact~     force measurement during ablation, and the long term success (12 months) of the ablation~     procedure using this technology.~   "
178887|NCT01223456|"~     This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA~     under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2~     and are prescribed ONGLYZA by their physician.~   "
178888|NCT01223443|"~     Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac~     events (death, myocardial infarction, target vessel revascularization) over the duration of~     follow-up.~      Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with~     paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac death,~     myocardial infarction or repeat revascularization related to the target SVG over the duration~     of follow-up (minimun of 2-year follow-up.~   "
178889|NCT01223430|"~     The purpose of this study is to determine whether simultaneously using the traditional~     Chinese medicine, Si-Ni-Tang, is more effective in the treatment of septic shock patients.~   "
178890|NCT01223404|"~     Many disorders where attentional problems are a hallmark, such as Alzheimer's disease and~     schizophrenia, display abnormal regulation of the so-called default network of resting brain~     function that maintains internally directed thought when the mind is free to wander. There is~     indication that nicotine may improve attention by aiding the deactivation of the default~     network, and this mechanism may be of therapeutic benefit for the above disease states. The~     current project aims at providing a proof of concept by demonstrating that nicotinic drugs~     modulate default network function. The nicotinic agonist nicotine is hypothesized to improve~     attention by facilitating the down-regulation of default network activity, and the nicotinic~     antagonist mecamylamine is hypothesized to impair attention by impeding the down-regulation~     of default network activity during attentional task performance.~   "
178891|NCT01223391|"~     The purpose of this study is to assess if abdominal binders that use pull strings to adjust~     compression (non-elastic) are more effective than standard elastic abdominal binders in~     attenuating neurogenic orthostatic hypotension.~   "
178892|NCT01223378|"~     The objective of this clinical investigation is to determine the most effective drug~     concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical~     development of an appropriate dose with regard to efficacy, and ocular and systemic safety.~   "
178893|NCT01223365|"~     The primary objective of this study is to evaluate the safety of hydrocodone extended-release~     tablets when used over a 12-month period in patients with chronic pain, as assessed by~     adverse events, clinical laboratory results, vital signs measurements, electrocardiogram~     results, physical examination findings, pure tone audiometry, and concomitant medication~     usage.~   "
178894|NCT01223352|"~     The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two~     dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial~     hypertension (PAH) <12 years of age.~   "
178895|NCT01223339|"~     This study is to characterize the pharmacokinetics, safety, tolerability, and~     pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729,~     MK-8835) in Japanese healthy participants. The secondary objective is to investigate the~     safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ertugliflozin~     in Western healthy participants as compared to Japanese healthy participants.~   "
178896|NCT01223326|"~     Study hypothesis: N-acetylcysteine (NAC) can reduce ischemia/reperfusion injury in liver~     resection performed under ischemic preconditioning and intermittent portal triad clamping.~   "
178897|NCT01223313|"~     WHAT IS THE FEMALE CONDOM? The female condom being examined in this study is investigational~     (experimental) and is not yet approved by the Food and Drug Administration (FDA). The female~     condom is made up of a pouch that adjusts to the shape of the vagina. The female condom that~     will be used in this study is not lubricated, but a water-based lubricant will be provided~     for you to use with it. Also, the female condoms used in this study will be provided to you~     at no cost.~      WHY IS THIS STUDY BEING DONE?~      The purpose of this study is to find out:~        -  How well the female condom works to prevent pregnancy~        -  How well the female condom works to prevent transmission of sexually transmitted~          diseases~        -  How safe the female condom is to use~        -  If urinary tract infections and symptomatic vaginal infections occur while using the~          female condom~        -  How well women like the female condom~        -  How well the female condom performs.~      WHAT DOES THE STUDY INVOLVE? There will be approximately 10 clinics in the study with about~     500 women from all over the United States participating in this study. You are being asked to~     participate in a research study because you are a woman between the ages of 18 and 40, are in~     general good health, have regular menstrual cycles, do not want to become pregnant for at~     least the next 7 months, and are willing to rely on the female condom as your primary method~     of contraception during study participation.~      HOW LONG DOES THE STUDY LAST? Enrollment for this study is expected to last about 12 months.~     You will need to come to the clinic for a screening/admission visit and then 2 or more~     visits. You will also be asked to complete a diary every day about your use of the female~     condoms. The clinical staff will help set up your planned clinical visits during the study.~   "
178898|NCT01223300|"~     The aim of this research registry is to collect information on individuals with osteoporosis,~     those with risk factors for osteoporosis, and comparative healthy controls. Bone mineral~     density measurements will be done on these individuals to determine bone health.~   "
178899|NCT01223287|"~     This observational study was conducted to design and test a physiologic definition for~     bronchopulmonary dysplasia at 36 weeks of life. Infants were studied in a supine position~     with the pulse oximeter in position with good signal prior to collecting baseline data.~     Feedings and medications were given 30 minutes before the evaluation. Baseline data was~     collected on infant's current oxygen. Then, the infants were weaned to room air for 30~     minutes. If saturations remain ≥90%, the infant was considered to have passed the oxygen~     reduction challenge (to NOT have BPD). The infant should then be placed back in his/her~     baseline oxygen. If the infant has saturations <90% for 5 continuous minutes or <80% for 15~     seconds, the infant should be immediately placed back in his/her baseline oxygen, and the~     infant was considered to have NOT passed the challenge (to have BPD).~   "
178900|NCT01223274|"~     This pilot study was designed to determine the feasibility of randomizing extremely low birth~     weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two~     resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway~     pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure~     (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP~     and no PEEP if the infant required PPV (the control group).~   "
178901|NCT01223261|"~     The purposes of this study were: 1) to compare mortality and postoperative morbidities in~     extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for~     necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the~     ability to distinguish NEC from IP preoperatively and the importance of this distinction on~     outcome measures; and 3) to evaluate the association between extent of intestinal disease~     determined at operation and outcome measures. All ELBW infants born at participating NRN~     centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon~     and neonatologist to require surgical intervention. Data were collected enrolled infants,~     including: intraoperative findings recorded by the surgeon and specific post-operative~     complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22~     months corrected age.~   "
178902|NCT01223248|"~     The purpose of this study is to find out which way of giving high-dose radiation works best~     for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This~     study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days)~     or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy~     (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the~     exposure to normal tissue. Currently there are no studies that compare the effects of giving~     radiation in either hypofractionated doses (higher total doses of radiation spread out over~     several treatment days) or a single-fraction dose (entire radiation dose given in one~     treatment session).~      The patient may be asked to participate in an additional part of this study where we will get~     a a (DW/DCE) MRI before treatment start and within one hour after radiation treatment. If the~     patient is asked to take part in this portion of the study, all they will need to do is get~     up to 3 MRIs with standard contrast injection. The purpose of this is to see if as a result~     of the treatment there are changes in the blood flow going to the cancer which could suggest~     that the treatment may be successful.~      In addition some patients can present new lesions and may be asked if they would like to have~     these new lesions treated on the protocol. If they are given this option, this will not~     extend their follow up period. The follow up of the new lesions will match with the prior~     follow up dates.~   "
178903|NCT01223235|"~     The immune system of the body has the ability to fight and eliminate infections and cancers.~     Immune treatments, such as in this study, seek to teach the immune system to find and destroy~     cancer cells. The purpose of this study is to test whether it is safe to treat the cancer~     with a vaccine and another drug called bevacizumab (also known as Avastin).~   "
178905|NCT01223209|"~     This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001).~     This will be tested in patients that have had surgery with curative intent for malignant~     tumour.~      GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to start~     the immune response in the body to have effect of GV-1001.~      LTX-315, also a peptide, in development for cancer treatment. In this study, the~     investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating~     the immune system.~   "
178906|NCT01223196|"~     Background: Pioglitazone has been shown to have potent anti-inflammatory as well~     anti-atherosclerotic effects. However, the mechanisms by which pioglitazone exerts these~     effects are not clear. The investigators propose that Tissue Inhibitor of MetalloProteinase-3~     (TIMP-3) and TNF-alfa converting enzyme (TACE) play a major role in pioglitazone mediated~     improvement in insulin sensitivity and endothelial function. In animal models, low dose~     pioglitazone inhibits lesion progression and matrix metalloproteinase expression in advanced~     atherosclerotic plaques. The investigators believe that a lower dose of Pioglitazone will~     also have anti-inflammatory effects.~      Aim: To examine the effect of low dose Pioglitazone (15mg/day) on TIMP and TACE in~     Pioglitazone mediated improvements in insulin sensitivity.~      Methods: Thirty subjects with T2DM will participate in following studies: (i) oral glucose~     tolerance test (OGTT); (ii) Dual energy absorptiometry(DXA) for body fat content, (iv)~     skeletal muscle biopsy. Subjects will be randomized to receive either placebo or pioglitazone~     for 24 weeks. The investigators will study the effect of Pioglitazone on (1) TIMP and TACE~     substrate activity in skeletal muscle, adipose tissue, mononuclear cells, and their~     relationship to insulin sensitivity and vascular reactivity, other adipocytokines- resistin,~     TNF-α and Visfatin; (2) markers of inflammation and atherosclerosis- C-reactive protein,~     VCAM-1 (vascular cell adhesion molecule 1), ICAM-1 (Intercellular Adhesion Molecule 1),~     endothelin 1, E-selectin, P-selectin, TNFrecI (Tumor Necrosis Factor Receptor I), TNFrecII~     (Tumor Necrosis Factor Receptor II), IL-6 (Interleukin 6) receptor.~   "
178907|NCT01223183|"~     Blockage of the breathing tubes of the lungs by thick, sticky mucus is a major cause of lung~     problems for people with cystic fibrosis (CF). Many researchers now believe that people with~     CF absorb too much water from the insides of their lungs, and that the mucus in their lungs~     becomes so thick and sticky because there is not enough water in it. The investigators are~     trying to develop ways to measure how fast water is absorbed from the breathing tubes in the~     lung so that the investigators can more quickly test new medications that are being developed~     to fix this problem for CF patients. The investigators have already done studies showing that~     people with CF absorb a particular radioactive drug (Indium-111 diethylenetriaminepentaacetic~     acid or In-DTPA) from their lungs more quickly than people without CF. Now the investigators~     are trying to prove that the absorption of this drug is related to the absorption of water.~     The investigators measure the absorption of In-DTPA by delivering it in an aerosol (inhaled~     mist) along with another radioactive drug (Technetium 99m sulfur colloid or Tc-SC). This~     other drug helps us measure how much material is cleared from the lungs in other ways (like~     coughing) without being absorbed. In this study, the investigators will measure how the~     absorption of In-DTPA is affected by inhaling isotonic saline and hypertonic saline (salt~     water), both of which the investigators know affect the absorption of water in the airways.~   "
178908|NCT01223170|"~     Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading~     causes of death and represent 30% of all global deaths and 48% of the deaths in Europe.~     Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases~     over the next years. Secondary preventive efforts can decrease mortality risk as well as~     improve health among Cardiovascular Disease patients.~      This study suggests an innovative approach in supporting the self-management of~     Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled Trial~     has two arms and aims to investigate the effectiveness of tailoring in an Information and~     Communication Technology (ICT) based intervention. The tailoring will be based on concepts~     derived from health psychology theories, and will contribute in their further development.~     More specifically:~        -  Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met~          through the use of ICT.~        -  Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance of~          self-management behaviors after a rehabilitation stay. Hypothesis: The intervention~          group (tailored) will have higher adherence a) to the Internet-based intervention, and~          b) to self-management.~        -  Aim 3: To assess the effect of mobile technology with activity sensors on physical~          activity. Hypothesis: There will be a relationship between the data collected from~          activity sensors and the self-reported physical activity levels.~   "
178909|NCT01223157|"~     Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive~     procedures. The investigators managed in the lab to determine the levels of endocannabinoids~     in a small number of subjects. The aim of the study is to confirm that salivary is a useful~     tool to evaluate the activity of the ECS both in normal weight and obese subjects that are~     characterised by a hyperactivity of the system. Therefore, the first objective of the study~     is to compare the fasting level of salivary anandamide between 12 obese patients and 12~     normal weight subjects.~   "
178910|NCT01223144|"~     The present study aims at investigating cognitive functions requiring orbitofrontal control,~     namely decision-making and facial emotion recognition. The investigators hypothesize that~     decision-making and facial emotion recognition are impaired in patients with essential tremor~     (ET) due to frontal lobe dysfunction which may have consequences in daily social life.~   "
178927|NCT01222923|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     Risperidone formulations after administration of single doses to normal, healthy subjects~     under fed conditions.~   "
178928|NCT01222910|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing valacyclovir~     hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX®~     caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy,~     adult, male, human subjects under fasting condition.~   "
179013|NCT01221805|"~     The purpose of this study is to demonstrate the ability of STA® Liatest® D-Di combined with a~     clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous~     Thrombosis (DVT) in a 3 month follow-up.~   "
178911|NCT01223131|"~     Primary Objective:~      6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin~     (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM)~     aged at least 6 years to less than 18 years.~      Secondary Objectives:~        -  To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:~             -  Percentage of patients reaching International Society of Pediatric and Adolescent~               Diabetes (ISPAD) recommended target of HbA1c < 7.5%,~             -  Fasting blood glucose (FBG),~             -  Nocturnal blood glucose (BG),~             -  24-hour blood glucose profile based on 8-point self-monitoring of blood glucose~               (SMBG) values,~             -  Daily total insulin dose and basal insulin dose,~             -  Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal~               symptomatic hypoglycemia.~        -  To assess the safety and tolerability of insulin glargine versus NPH insulin based on~          the occurrence of treatment-emergent adverse events (TEAEs).~        -  To assess anti-insulin and anti-glargine antibody development in both groups.~        -  To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin~          glargine in selected sites with approximately 45% of insulin glargine population to rule~          out accumulation tendency of insulin glargine after repeated dosing~   "
178912|NCT01223118|"~     The purpose of this study is to determine the rate of cryosurvival of mature oocytes~     following vitrification, and to then compare the reproductive potential of vitrified oocytes~     relative to those which have not been cryopreserved.~   "
178913|NCT01223105|"~     This study seeks to evaluate whether the vitrification technique, as compared to the more~     traditional slow-cooling technique, leads to higher rates of successful thawing,~     fertilization, implantation and delivery.~   "
178914|NCT01223092|"~     The purpose of this this study is to use DNA screening strategies to identify genes and~     localize genomic regions that are differentially expressed in patients with infertility to~     further understand the genetic basis for reproductive competence.~   "
178915|NCT01223079|"~     The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late~     follicular phase of young women undergoing controlled ovarian stimulation for oocyte~     donation.~   "
178916|NCT01223066|"~     The study objective is to evaluate the long term safety when Macrolane Volume Restoration~     Factor is used in female breasts in clinical practice.~   "
178917|NCT01223053|"~     Transdel Pharmaceuticals is investigating a topical cream formulation consisting of 10%~     ketoprofen for the local treatment of pain associated with mild to moderate acute soft tissue~     injury in this confirmatory Phase 3 trial.~   "
178918|NCT01223040|"~     The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane~     Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye~     patients.~   "
178919|NCT01223027|"~     This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients~     with metastatic renal cell cancer.~   "
178920|NCT01223014|"~     Phase I study to evaluate the excretion of radioactivity, the metabolic profile,~     pharmacokinetics, safety and tolerability following a single oral administration of~     [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this~     study is to investigate how and how quickly AZD 2423 or its break down products are excreted~     by analysing blood, faeces and urine samples collected during the study.~   "
178921|NCT01223001|"~     The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth~     daily with placebo in the prevention of depression associated with mild/moderate traumatic~     brain injury and to enhance cognitive function.~   "
178922|NCT01222988|"~     Obtain a preliminary assessment of the feasibility and acceptability of delivering the~     sustained lost weight (SLW) intervention in a real-world clinical setting for patients who~     have completed a 21-week very low calorie diet (VLCD).~      Hypothesis: Intervention will be feasible to implement as evidenced by the ability to recruit~     and retain participants and acceptable to participants as evidenced by self-report of~     satisfaction with the program and adoption of weight maintenance behaviors.~      Secondary Aim: Obtain a preliminary assessment of the effectiveness of the sustained lost~     weight (SLW) intervention for patients who have completed 21 weeks of a very low calorie diet~     (VLCD).~      Hypothesis: Greater than 75% of participants who receive this novel approach, where~     maintenance behaviors are individualized based on resting metabolic rate and a physical~     activity factor, will regain greater or equal to 10 kg. at week 52 follow-up.~   "
178923|NCT01222975|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     Risperidone formulations after administration of single doses to normal, healthy subjects~     under fasted conditions.~   "
178924|NCT01222962|"~     The study was designed to assess the effect of food on the extent and rate of absorption of~     Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose~     combination (Eurartesim™).~   "
178925|NCT01222949|"~     The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers~     and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the~     relative bioavailability of DHA and PQ.~   "
178926|NCT01222936|"~     SCLC is the most aggressive and lethal form of lung cancer, typically very sensitive to~     cytotoxic therapy when first diagnosed, but associated with a high incidence of tumour~     relapse and a very poor life expectancy. Combination chemotherapy based on cisplatin or~     carboplatin and etoposide represents the most widely used regimen. Despite of the high~     response rate, approximately 80% of patients with limited disease and nearly all patients~     with extended disease develop disease relapse or progression. Topotecan is, at present, the~     only approved second line treatment in Europe.~      The search of a new therapeutic agent that could alter the natural history of SCLC would be~     an important goal to be reached. LBH589 (Panobinostat) is a histone deacetylase (HDAC)~     inhibitor available for intravenous and oral administration. LBH589 could be classified as~     PAN-DAC inhibitor targeting both histone and non histone proteins and as such it could be~     suitable for combination with cytotoxics. Three phase I dose escalation studies with both the~     intravenous and the oral formulation of LBH589, examining various dose schedules of~     administration have been conducted in advanced solid tumours and haematological malignancies.~      Single agent activity was observed in phase I in patients with haematological cancer. In~     solid tumours one response (Hormone-refractory Prostatic Cancer) and some prolonged~     stabilizations have been observed with intravenous formulation. Phase II studies are now in~     progress.~   "
178929|NCT01222897|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Valacyclovir~     hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX®~     caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy,~     adult, male, human subjects under fed condition.~   "
178930|NCT01222884|"~     The purpose of this study is to compare the efficacy and safety of intravenous iron~     isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic~     Kidney Disease on Dialysis Therapy (CKD-5D).~   "
178931|NCT01222871|"~     The purpose of this study is to compare the effectiveness of intranasal Triamcinolone~     delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked~     dressing, in the treatment and prevention of early nasal polyposis.~   "
178932|NCT01222858|"~     The proposed project addresses the significant problem of obesity and uses innovative~     technology to improve adherence to a behavioral weight loss strategies. If the program is~     effective, it would provide an outstanding resource for physicians to use with their patients~     and thus would have tremendous clinical impact.~   "
178933|NCT01222845|"~     The purpose of this study is to assess the postprandial glycaemic, insulinaemic and appetite~     responses to porridge made with oats processed differently.~   "
178934|NCT01222832|"~     This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a~     sponge soaked in Saline / and the administration of oral antibiotics.~   "
178935|NCT01222819|"~     Granulocyte colony stimulating factor (G-CSF) is frequently used among patients with cancer~     including those with haematological malignancies.~      Filgrastim is a recombinant human CSF whose biological activity is similar to that of~     endogenous G-CSF.~      In the treatment of chemotherapy-induced neutropenia in patients with various types of cancer~     CSFs significantly reduced the time to neutrophil recovery and length of hospitalization.~   "
178936|NCT01222806|"~     Background:~      - Cocaine addiction is often difficult to treat, particularly because exposure to others~     using cocaine or to pictures of cocaine may evoke cocaine craving and lead a person to resume~     cocaine use after having quit. Breaking this link with cocaine craving might improve~     treatment for cocaine addiction. Research suggests that repetitive pulses of transcranial~     magnetic stimulation (rTMS) applied to the skull can change nerve cell firing in the brain.~     rTMS was recently approved as a treatment for depression, and is being studied as a way to~     reduce drug craving. However, because only a few small studies have looked at the effects of~     rTMS on cocaine craving, more research is needed on whether it is effective in reducing~     cocaine craving and use in individuals who currently use cocaine on a regular basis.~      Objectives:~      - To determine whether transcranial magnetic stimulation can lower craving for cocaine when~     given in connection with cocaine-related images.~      Eligibility:~      - Individuals at least 18 years of age who have used cocaine for at least 2 years and~     currently using at least 3 times per week.~      Design:~        -  This study involves an initial screening visit, two brain imaging sessions, five rTMS~          sessions, and two follow-up visits.~        -  Participants will be screened with a medical history, physical examination, urine~          samples, questions about drug use history and previous efforts to quit, and tests for~          breath alcohol and nicotine levels.~        -  Participants will have two magnetic resonance imaging (MRI) scan sessions: one baseline~          scanning session before starting their rTMS sessions and a second scanning session after~          their last rTMS session . Part of each scanning session involves functional MRI (fMRI)~          scans. During the fMRI scans, participants will look at pictures related to cocaine use~          and pictures that are not related to cocaine use. Participants will also perform a~          simple decision task during the scans.~        -  Participants will have five rTMS sessions, one per day for 5 days in a row. Each session~          will last 1 to 2 hours. Participants will have either real or sham (simulated) rTMS~          while looking at pictures that may or may not be related to cocaine use, and will also~          perform a simple decision task that is the same as the one given during the MRI scans.~          The decision as to whether participants get real or sham rTMS will be made by chance.~          Neither the participants nor the investigators will know which type the participants are~          getting. - Participants will have two follow-up visits one and two weeks after their~          last rTMS session. At each visit they will be checked for cocaine and other substance~          use and for possible side-effects from rTMS.~   "
178937|NCT01222793|"~     Background:~      - Although second-generation antipsychotic medications have fewer serious side effects and~     complications than first-generation ones, they are strongly associated with weight gain for~     reasons that are as yet unknown. Comparing the effects of second-generation antipsychotics~     with a high weight-gain liability (HWGL) low weight-gain liability (LWGL) antipsychotics may~     provide more information on which medications are best suited for different individuals.~     Researchers are interested in studying how people taking various antipsychotics compare with~     controls in regard to food craving and eating behavior. This knowledge should help to guide~     practitioners when advising patients about the weight-gain effects of these medications.~      Objectives:~      - To examine eating behavior and food craving in patients with schizophrenia who are taking~     HWGL antipsychotics compared with those taking LWGL antipsychotics and with healthy controls~     taking no antipsychotics.~      Eligibility:~        -  Individuals between 18 and 45 years of age who have been diagnosed with schizophrenia or~          a related disorder, have a body mass index between 25 and 29.9, and have never had an~          eating disorder.~        -  Healthy individuals between 18 and 45 years of age who have a body mass index between 25~          and 29.9 and have never had an eating disorder.~      Design:~        -  This study involves an initial screening visit and four study visits.~        -  Participants will be screened with a medical history and physical examination, as well~          as questionnaires about stress levels, food cravings, smoking, exercise, and eating~          habits; a taste test; and saliva collection (to measure stress hormones).~        -  Visit 2: Participants will have an optional overnight stay, and will provide blood~          samples before having a breakfast beverage and answering questions about tiredness,~          anxiety, hunger, and alertness during a 1.5 hour session.~      Visit 3: Participants will have an optional overnight stay and a light breakfast, followed by~     blood draws and questions about hunger and food cravings.~      Visit 4: Participants will have an optional overnight stay, followed by questions about food~     preference. Participants will not be allowed to eat until mid-morning of the next day.~      Visit 5: Participants will eat normally before arriving at the research site, and will have~     tests to measure food craving and questionnaires about mood and feelings.~   "
178938|NCT01222780|"~     Background:~        -  Marqibo(Registered Trademark) is a new anticancer drug. It combines Vincristine sulfate,~          which is a widely used anticancer drug, and packages it into a tiny fat bubble known as~          a liposome. The goal of this is to improve the drug's ability to destroy cancer cells~          and help reduce the potential side effects of treatment.~        -  Vincristine sulfate was originally developed from chemicals found in the periwinkle~          plant and acts against multiple types of malignant cancer. It is approved for multiple~          cancer types including solid tumors and blood cancers.~        -  Research has shown that Marqibo(Registered Trademark) is able to slow or stop the growth~          of cancer cells in some adults, both alone and in combination with other chemotherapy~          drugs, but more research is needed to determine its use in children.~        -  There has been one previous small study of Marqibo(Registered Trademark) in children.~          Although some anti-cancer activity was seen, side effects and optimal dosing were not~          fully determined.~        -  As is seen with standard Vincristine suflate, the most common side effect of~          Marqibo(Registered Trademark) involves the nervous system. It can cause numbness and~          tingling in the hands and feet. Symptoms commonly improve when the drug is discontinued~          or the dose is lowered.~      Objectives:~      - To determine the safety and efficacy of Marqibo as a treatment for children who have been~     diagnosed with certain types of malignant cancer that has not responded to standard~     treatment.~      Eligibility:~        -  Children and adolescents between 2 and 21 years of age who have been diagnosed with~          certain types of malignant cancer that has not responded to standard treatment.~        -  These cancer types include solids tumors, primary brain tumors, leukemias, and~          lymphomas....~   "
178939|NCT01222767|"~     This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis®~     (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of~     Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy to determine the~     antitumor activity of Zalypsis.~   "
178950|NCT01222624|"~     This is a prospective, open label, dose escalating, multicenter, phase I study measuring the~     safety, tolerability, and pharmakokinetics of PankoMab-GEX™ after intravenous administration~     in patients with locally advanced or metastatic solid cancers refractory to standard~     treatment. The effect of PankoMab-GEX™ on the development of antibodies and tumor response~     will also be evaluated.~   "
179014|NCT01221792|"~     The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac~     effect, will reduce symptoms of Post Traumatic Stress Disorder.~   "
178940|NCT01222754|"~     Background:~      - Children who are diagnosed with brain tumors known as high grade gliomas or diffuse~     intrinsic pontine gliomas are generally treated with radiation therapy and chemotherapy.~     However, these tumors are very difficult to cure, and the tumor frequently begins to grow~     again even after treatment or surgery. Researchers are interested in determining whether the~     anticancer drug lenalidomide, which has been used to treat other aggressive types of cancer,~     is a safe and effective additional treatment for children who are scheduled to receive~     radiation therapy to treat high grade gliomas or diffuse intrinsic pontine gliomas.~      Objectives:~      - To determine the safety and effectiveness of lenalidomide, in conjunction with radiation~     therapy, as a treatment for children who have been diagnosed with high grade gliomas or~     diffuse intrinsic pontine gliomas.~      Eligibility:~      - Children and adolescents up to 21 years of age who have been diagnosed with high grade~     gliomas or diffuse intrinsic pontine gliomas and have not had radiotherapy or chemotherapy.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and imaging studies.~        -  Participants will have two phases of treatment: a lenalidomide plus radiation phase and~          a lenalidomide-only phase.~        -  During the radiation phase, participants will take lenalidomide daily and have 6 weeks~          of radiation therapy (five treatments per week). After the radiation therapy,~          participants will stop taking lenalidomide for 2 weeks before continuing to the next~          phase.~        -  During the lenalidomide-only phase, participants will take lenalidomide daily for 21~          days, followed by 7 days without lenalidomide (28-day cycle of treatment). Participants~          will have up to 24 cycles of lenalidomide.~        -  Participants will have frequent blood tests during the first cycle of treatment, and~          will have imaging studies or other tests as required by the study researchers.~        -  Treatment will continue until the disease progresses, the participant chooses to leave~          the study, or the researchers end the study....~   "
178941|NCT01222741|"~     Background:~      - Researchers are interested in studying disorders that make individuals more susceptible to~     fungal infections, specifically infections with the Candida yeast. These disorders are often~     related to problems with the immune system and may have genetic factors, which suggests that~     researchers should study not only the individual with the disorder, but also his or her~     first- and second-degree relatives (such as parents, siblings, children, and first cousins).~     To provide material for future research, individuals with immune disorders and their first-~     and second-degree relatives will be asked to provide blood and other samples for testing and~     comparison with samples taken from healthy volunteers with no history of immune disorders.~      Objectives:~      - To collect blood and other biological samples to study immune disorders that make~     individuals more susceptible to fungal infections.~      Eligibility:~        -  Individuals of any age who have abnormal immune function characterized by recurrent or~          unusual fungal infections, recurrent or chronic inflammation, or other types of immune~          dysfunction.~        -  First- or second-degree genetically related family members (limited to mother, father,~          siblings, grandparents, children, aunts, uncles, and first cousins).~        -  Healthy volunteers at least 18 years of age (for comparison purposes).~      Design:~        -  Participants will provide blood samples and buccal (cells from the inside of the mouth~          near the cheek) samples.~        -  Participants with immune disorders will also be asked to provide urine samples, saliva~          or mucosal samples, or skin tissue biopsies, and may also have imaging studies (such as~          x-rays) to collect information for research.~        -  Samples may be collected at the National Institutes of Health or at other clinical~          locations for the samples to the sent to the National Institutes of Health.~        -  No treatment will be provided as part of this protocol.~   "
178942|NCT01222728|"~     Background:~        -  Neurofibromatosis type II (NF2) is associated with tumors of the nerves, brain, and~          spinal cord. Most people with NF2 develop vestibular schwannomas, or tumors on the~          hearing and balance nerves. As they grow, vestibular schwannomas can cause hearing loss~          and balance problems. If they grow very large they can cause more serious problems, such~          as seizures, loss of eyesight, weakness, speech problems, and problems with the sense of~          touch. More research is needed into NF2 because researchers do not completely understand~          why these tumors occur or what makes them grow over time.~        -  Currently, tumor size is measured with magnetic resonance imaging (MRI) scans. However,~          MRI scans cannot predict how fast a tumor will grow. By using positron emission~          tomography (PET) scanning, researchers hope to be able to predict sudden growth spurts~          of tumors associated with NF2 and develop better treatment methods for this type of~          cancer.~      Objectives:~      - To use magnetic resonance imaging and positron emission tomography to better understand the~     growth of brain tumors in people with neurofibromatosis type II.~      Eligibility:~      - Individuals between 18 and 50 years of age who have been diagnosed with NF2 and have at~     least three untreated intracranial tumors.~      Design:~        -  This study requires an initial set of outpatient visits to the NIH Clinical Center that~          will last 7 to 10 days.~        -  Participants will have a physical and neurological examination and blood tests at the~          first visit. Participants will then have the following imaging studies to examine the~          tumors:~        -  MRI scans of the brain~        -  PET scans of the brain, combined with a computed tomography (CT) scan. The PET scans~          will be performed on separate days. Different contrast agents will be used for both~          scans, so researchers will inform participants if they need to fast or follow other~          procedures before having the scan.~        -  After the initial imaging studies, participants will have additional MRI scans every 6~          months for 2 years to track tumor growth.~   "
178943|NCT01222715|"~     This randomized phase II trial studies how well vinorelbine tartrate and cyclophosphamide~     work in combination with bevacizumab or temsirolimus in treating patients with recurrent or~     refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of rhabdomyosarcoma by blocking blood flow to the tumor.~     Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. It is not yet known whether combination chemotherapy is more effective when~     given together with bevacizumab or temsirolimus in treating rhabdomyosarcoma.~   "
178944|NCT01222702|"~     Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated~     diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the~     study was to evaluate the efficacy and safety of different doses of cadazolid in order to~     find the dose of cadazolid to be used for further clinical development of the compound in~     subjects with CDAD.~   "
178945|NCT01222689|"~     This phase II trial studies how well giving selumetinib and erlotinib hydrochloride together~     works in treating patients with locally advanced or metastatic pancreatic cancer that is~     refractory to chemotherapy. Selumetinib and erlotinib hydrochloride may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
178946|NCT01222676|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.~     Giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate may kill more~     tumor cells. Giving them before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving cisplatin and gemcitabine~     hydrochloride together with sorafenib tosylate works in treating patients with node-negative~     transitional cell cancer of the bladder.~   "
178947|NCT01222663|"~     The purpose of this randomized, comparative, open and multi-centre study is to show that two~     sessions of hemoperfusion with Toraymyxin performed within maximum 36 hours after the surgery~     of a peritonitis by hollow organ perforation reduce the mortality in patients suffering from~     septic shock.~   "
178948|NCT01222650|"~     The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to~     placebo for the treatment of LUTS caused by BPH.~   "
178949|NCT01222637|"~     This is a prospective, open label, multicenter study evaluating the safety, tolerability and~     pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR positive,~     locally advanced and/or metastatic solid cancers. The effect of CetuGEX™ on the development~     of anti-drug antibodies and on tumour response will also be evaluated.~   "
179015|NCT01221779|"~     The purpose of this study is to determine if non-invasive electrical brain stimulation can~     enhance the out of intensive language therapy in chronic aphasia~   "
178951|NCT01222611|"~     This study examines the impact of fosamprenavir as part of an ART on virological,~     immunological and clinical parameters of genotype 1 HCV infection in HIV co-infected~     subjects. Fosamprenavir could have a direct or immune-mediated activity against HCV. If this~     is shown to be true, changes in HCV viral load or biological characteristics could be~     demonstrated.~   "
178952|NCT01222598|"~     This is a confirmation of safety profile for Minirin Melt in clinical practice.~   "
178953|NCT01222585|"~     Yearly in the United States over 500,000 newborns are delivered prematurely. This population~     is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants~     with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk~     of mental retardation. Metronidazole is an antibiotic that is often administered to infants~     with suspected or confirmed necrotizing enterocolitis. Unfortunately, the appropriate dose of~     metronidazole in premature infants has not been established and it is likely to be different~     from older children and adults.~      The investigators will investigate the appropriate metronidazole dose in very premature~     infants by: 1) determining how premature infants eliminate metronidazole from the body and 2)~     determining the safest and most effective dose of metronidazole in premature infants.~      The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with~     infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary~     drug levels to treat bacteria involved in necrotizing enterocolitis.~   "
178954|NCT01222572|"~     In this research study the investigators are looking for the highest dose of a stereotactic~     radiation boost that can be given safely. Because stereotactic radiation is so precise, the~     investigators are testing whether it can be used to increase the dose to the primary tumor~     without significantly increasing the side effects the participant experiences; the goal is to~     improve the likelihood of killing the tumor.~   "
178955|NCT01222559|"~     This is a prospective, phase III, multicenter, open label, randomised clinical trial of~     co.don chondrosphere®, a three-dimensional autologous chondrocyte transplantation product~     (ACT3D-CS)compared to the procedure of microfracture (MF)in the treatment of cartilage~     defects of knee joints.~      After screening visit patients were booked for arthroscopy and at that time they were~     randomised to either ACT3D-CS with co.don chondrosphere® (Group A) or to MF(Group B), a~     marrow-stimulating method based on the penetration of the subchondral bone plate at the~     bottom of the cartilage defect. At the time of arthroscopy Patients of group B had their~     procedure of MF (treatment surgery) and patients of group A had their cells harvested from~     healthy cartilage. The cells are cultivated for 8-10 weeks in vitro to develope 3-dimensional~     spheroids , that are transplanted in an open knee procedure (treatment surgery)into the~     defect. Patients subsequently followed the same rehabilitation program and had post-surgery~     visits. After the 12-month-visit a interim analyses will be performed and the 24-month-visit~     is defined as final assessment. Then patients have follow-up assessments up to 60 months~     post-treatment-surgery.~   "
178956|NCT01222546|"~     This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety,~     pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients~     with advanced solid tumors.~   "
178957|NCT01222533|"~     The purpose of this study is compare the effect of different doses of tiotropium delivered by~     the HandiHaler and Respimat device on lung function. Additionally, the study will investigate~     the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile~     shows what happens to the medication in the body over a period of hours and provides~     information on potential effects of the medication.~   "
178958|NCT01222520|"~     If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an~     antihypertensive drug from different class should be started concomitantly.~      In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential~     hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg,~     the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg~     monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan~     80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her~     blood pressure controlled with telmisartan 80 mg.~      Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and~     safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different~     pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with~     telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who~     fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg~     monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy,~     active-controlled, parallel group comparison method is employed.~   "
178959|NCT01222507|"~     The overall purpose of this research is to assess whether both the 60 second Brain Game and~     the Brain Speed Test computer-based programs can be used as assessment tools for~     objectively defining the severity of the functional impact of tinnitus.~   "
178960|NCT01222494|"~     The US prevalence of childhood-onset obesity and type 2 diabetes, both predictors of~     cardiovascular risk, have increased to epidemic proportions in recent decades. Children with~     mental illness, especially those treated with antipsychotic medications, are at additional~     risk for obesity (adiposity) and related risk conditions. A variety of noninvasive techniques~     to assess cardiometabolic risk have begun to be applied in children, including body~     composition measured with dual energy x-ray absorptiometry (DEXA), carotid intima media~     thickness (CIMT) measured by ultrasound, and hepatic triglyceride content (HTGC) measured by~     1H Magnetic Resonance Spectroscopy (MRS). These measures allow for the early, noninvasive~     study of adiposity-related metabolic risk. The overall aim of this two-study research plan is~     to characterize the level of measurable risk using these sensitive markers in treated and~     untreated children with mental health disorders, and to evaluate the magnitude of change in~     risk that can be observed using these biomarkers in children receiving a well established~     behavioral weight-loss intervention.~   "
178973|NCT01222325|"~     In order to check if a reduction in the frequency and total number of shocks delivered during~     extracorporeal shockwave lithotripsy (SWL) results in a great number of stone-free~     patients,the investigators compared two different ways of treating urinary stones using SWL.~   "
179016|NCT01221766|"~     This research study will help us learn more about how chronic graft-versus-host disease~     affects the skin, hair and nails. We are interested in knowing if hair and nail problems~     predict worse disease. This information may help us treat patients like you in the future.~   "
178961|NCT01222481|"~     Cancer survivorship has dramatically improved within the last four decades and a greater~     number of Americans are living after cancer diagnosis. An increase in the number of survivors~     has highlighted the need to investigate the quality of life experienced by these survivors.~     While Survivorship research has improved our understanding of the challenges faced by some~     cancer survivors, there is a paucity of research on the functional and cognitive health~     status of head and neck cancer survivors.~      The purpose of this study is to evaluate the functional and cognitive changes that occur in~     head and neck cancer patients as a result of cancer treatment, in an attempt to increase our~     understanding of the complex interactions between cancer treatment, comorbid health ailments~     and quality of life.~   "
178962|NCT01222468|"~     This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on~     spasticity in spinal cord injured persons.The study will be a phase 2, randomized,~     placebo-controlled crossover study. Each eligible subject will participate for 26~     weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the~     study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the~     first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the~     opposite arm for another 11 week treatment period (phase 2).~   "
178963|NCT01222455|"~     A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic~     (liver) function compared with healthy volunteers with normal liver function. The study will~     also evaluate safety and tolerability in subjects with hepatic impairment.~   "
178964|NCT01222442|"~     The purpose of this research study is to evaluate the effect of AZD3199 on the electrical~     activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic~     (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known.~     Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will~     also be assessed.~   "
178965|NCT01222429|"~     This study aims to test a dietary intervention for diabetes in a medical practice setting,~     with the aim of developing a model for diabetes care that can be used widely. The~     investigators hypothesize that a low-fat vegan diet will be effective for management of~     diabetes and will be feasible in a practice-based setting.~   "
178966|NCT01222416|"~     The purpose of this study is to develop Positron Emission Tomography (PET) - Computed~     Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast~     cancer.~   "
178967|NCT01222403|"~     This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women~     aged 65 years and older.~   "
178968|NCT01222390|"~     The purpose of this study is to explore the volume change and location of volume change in~     reconstructed breasts using the Contour Profile® tissue expander. Our purpose is also to~     investigate the safety of using CPX3® in tissue-expander breast reconstruction via a~     comparison between the complication rates that result from this study and the complication~     rates with the use of other tissue expander types, as reported in the literature. We also~     hope to demonstrate the use of 3-D imaging technology as an objective measure of upper and~     lower breast volume change and location of this volume change in the reconstructed breast.~     Finally, we intend to provide reconstructive surgeons with a scientific study that quantifies~     the patient satisfaction with aesthetic results of CPX3 in tissue expander-implant breast~     reconstruction. We hypothesize that the CPX3 tissue expander will provide more lower pole~     volume expansion when compared to lower pole volume expansion from round, standard tissue~     expanders as reported in the literature. Additionally, we hypothesize that CPX3, in~     combination with human acellular dermis, is less prone to complications than standard tissue~     expanders (again, as reported in the literature).~   "
178969|NCT01222377|"~     RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast~     cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial~     studies endoscopic breast surgery in treating patients with breast cancer.~   "
178970|NCT01222364|"~     This study tested the feasibility of conducting a randomized controlled trial to vary the~     timing that doctors clamp the umbilical cord after birth in extremely low birthweight~     infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding~     the newborn approximately 10 inches below the birth canal would result in increased~     hematocrit at 4 hours of age.~   "
178971|NCT01222351|"~     The overall goal of this project is to establish and validate biomarkers associated with the~     risk and progression of late onset Alzheimer's disease, mild cognitive impairment and~     cognitive decline. The investigators will use baseline and longitudinal measurements of~     plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild~     cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive~     decline and Alzheimer's disease progression. Participants will be selected on the basis of~     change in plasma amyloid beta levels over prior assessment intervals. The purpose of the~     study is to examine whether brain amyloid plaque load, which will be measured with positron~     emission tomography and x-ray computed tomography brain imaging using Florbetaben from Bayer,~     varies as a function of change in plasma levels of amyloid beta. The driving hypothesis of~     the study is that high plasma levels of amyloid beta are an antecedent indicator of increased~     risk of cognitive decline, mild cognitive impairment, and incident late onset Alzheimer's~     disease, and that declining plasma levels of amyloid beta are associated with the onset of~     cognitive decline. Further, high plasma levels of amyloid beta are related to increased~     levels of amyloid beta in the brain as measured by positron emission tomography positivity,~     and the specific pattern of positron emission tomography positivity and a decline in plasma~     amyloid beta over time are associated with the onset of cognitive decline associated with~     late onset Alzheimer's disease.~   "
178972|NCT01222338|"~     Treatment of multidrug-resistant TB (MDR-TB) is 100 times more expensive than treatment of~     drug-susceptible TB, requiring intensive clinical management for prolonged time (18-24~     months) and more toxic treatment course. In prior open label study the investigators have~     shown that adding V-5 Immunitor (V5), can reduce treatment duration to one month and enhance~     by 4-5 fold the efficacy of TB drugs. Furthermore, V5 has been shown to reverse or reduce~     liver damage caused by chemotherapy. The cost of V5 will be very modest. The investigators~     propose to conduct placebo-controlled clinical trial in patients with treatment refractory TB~     so that the clinical benefit of V5 is confirmed.~   "
178974|NCT01222312|"~     The study compares two combinations of chemotherapy in patients with advanced or metastatic~     NSCLC: 50% of the patients are treated with cisplatin and docetaxel, the other 50% with~     oxaliplatin and docetaxel. cisplatin is today the standard therapy, but the toxicity profile~     is often not tolerable. Especially in elderly patients or patients with comorbidities,~     oxaliplatin based chemotherapy may have lower toxicities but comparable or even better~     response rates.~   "
178975|NCT01222299|"~     The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal~     product in seasonal allergic rhinitis patients.~   "
178976|NCT01222286|"~     The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of~     two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.~   "
178977|NCT01222273|"~     The purpose of this study is to see if giving people with CF and ABPA enough vitamin D to~     make their blood levels of the vitamin higher, will reduce the allergic response in their~     body and make the symptoms caused by ABPA better.~   "
178978|NCT01222260|"~     The study is being done to see if the combination of bendamustine and dexamethasone will help~     people with amyloidosis that has returned after standard treatment, and to to estimate the~     partial hematologic response rate (PHR).~   "
178979|NCT01222247|"~     Infants born between 34 and 36 weeks of gestation, known as 'late preterm', are more likely~     to be admitted to a special care nursery, and more likely to suffer respiratory complications~     than infants born at term. The use of antenatal corticosteroids has been shown to improve~     lung function in very premature infants, but has not been evaluated in those likely to~     deliver in the late preterm period.~      This research study will attempt to answer the following primary research question: Do~     steroids, compared to no steroids, decrease babies' need for oxygen support when given to~     pregnant women at least 12 to 24 hours before they deliver at 34 weeks to 36 weeks gestation?~     The research study will also collect information on whether steroids improve the chances that~     the baby will not get sick from other causes.~   "
178980|NCT01222234|"~     This investigation will consist of a prospective study utilizing two separate populations of~     patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one~     with normal renal function.~   "
178981|NCT01222221|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine~     therapy together with temozolomide and radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given~     together with temozolomide and radiation therapy in treating patients with newly diagnosed~     glioblastoma multiforme.~   "
178982|NCT01222208|"~     A prospective, randomized controlled study, using stable isotope methodology, is proposed to~     determine whether an oral nutrition support regimen, containing pressurized whey protein and~     glucose, is more effective at normalizing the metabolic response to surgery than a standard~     peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in~     colorectal surgical patients studied before and after surgery. The effectiveness of the~     nutrition support regimens will be determined by: whole body protein balance, synthesis rates~     of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well~     as circulating metabolites concentrations.~   "
178983|NCT01222195|"~     The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa~     given together will help to control the need for transfusions in patients with low to~     intermediate risk Myelodysplastic Syndrome (MDS). The safety of this combination will also be~     studied.~   "
178984|NCT01222182|"~     A group of ~ 225 patients were switched from atorvastatin to an equivalent statin either by~     their physicians usual management or by an collaborative pharmacist coordinated process. We~     will compare the results of pharmacist process to the standard medical practice to find~     potentially which process is more effective, safer and efficient. We are surveying a total of~     35 physicians, 12 using the pharmacist coordinated process and 23 not, comparing their~     satisfaction of the 2 processes.~   "
178985|NCT01222169|"~     To describe respiratory and laryngeal responses to laryngeal stimulation during propofol~     anesthesia in children. To determine whether the co-administration of lidocaine blunts these~     reflex responses. The outcome of primary interest is the reflex laryngospasm.~      Hypotheses:~      I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv.~     administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol~     (3mcg/ml).~      II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv.~     administration of lidocaine is equivalent to the response before the administration of~     lidocaine.~   "
178986|NCT01222156|"~     The Magnetecs Catheter Guidance Control and Imaging (CGCI) system is a magnetic remote~     navigation system which is comprised of a magnetic chamber of eight electromagnets around the~     patient torso. The system can change the magnetic field almost instantaneously and enables~     almost real time manipulation of a special magnetic catheter (Maxwell mapping catheter) which~     results in accurate, repeatable, rapid and safe target acquisition within the four chambers~     of the human heart.~      The trial is a prospective, non-randomized, clinical one designed to test the study~     hypotheses of (a) technical equivalence of the study device in comparison to other magnetic~     remote navigation systems, (b) performance equivalence or non-inferiority of the study device~     target acquisition capability compared to presently used catheter navigation techniques, and~     (c) safety equivalence or non-inferiority of the study device in comparison to catheter~     navigation devices using other navigation techniques.~   "
179009|NCT01221857|"~     Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a~     UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second,~     Unmanipulated CBU in Patients with Hematological Malignancies~   "
179010|NCT01221844|"~     The purpose of this study is to determine whether bovine lactoferrin is effective in~     preventing and curing iron deficiency and iron deficiency anemia in Hereditary Thrombophilia~     affected women during pregnancy.~      The proposed clinical trial is considered as PHASE IV because in Italy bLf is commercialized~     by Grunenthal, as Lattoglobina® (capsules with 100 mg of bLf), to prevent and cure iron~     deficiency and iron deficiency anemia in pregnant women.~   "
178987|NCT01222143|"~     This is a phase I/II open-label study that is evaluating the toxicity and efficacy of~     nilotinib combined with mitoxantrone, etoposide, and high-dose cytarabine (NOVE-HiDAC)~     chemotherapy for patients with poor-risk acute myeloid leukemia (AML). There are two parts to~     the study. The first part (Phase I) will determine the maximum dose of nilotinib that can~     safely be given when combined with NOVE-HiDAC. This dose will then be used in combination~     with the NOVE-HiDAC regimen in the second part of the study (Phase II), which will evaluate~     the antileukemic activity of the treatment. The patients who achieve complete remission from~     the induction therapy (1 cycle) will then receive consolidation therapy combined with~     nilotinib (maximum of 2 cycles).~      The patient population for this study will have AML and will fall into a poor risk category.~     This means they have persistent leukemia after induction therapy, they relapse within two~     years of achieving complete remission with induction therapy, or they have certain poor risk~     features at diagnosis. The AML cells will also be positive for c-kit (a stem cell factor~     receptor), which is involved in cancer cell growth. Nilotinib is a drug that blocks the~     effects of c-kit. Using this drug in combination with chemotherapy may improve ability of the~     chemotherapy drugs to kill leukemia cells. This may then increase the chances of the leukemia~     going into complete remission.~   "
178988|NCT01222130|"~     This study is designed to develop and evaluate a set of non-virologic diagnostic algorithms~     to monitor HIV-exposed children of unknown infection status for treatment eligibility during~     the first year of life. The results of this cross sectional study are expected to be used in~     development of a series of non-virologic algorithms to determining treatment eligibility~     among HIV-exposed children in settings where polymerase chain reaction (PCR) testing is not~     available and to guide the judicious use of PCR testing among HIV-exposed children in~     settings where PCR is available. These results will directly inform program implementation in~     Zambia.~   "
178989|NCT01222117|"~     The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing~     different delivery regimens in patients with peripheral arterial occlusion. The study~     includes a blinded plasminogen activator treatment group and a blinded plasminogen activator~     placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250~     mg doses.~   "
178990|NCT01222104|"~     The purpose of this study is to collect data on the standard of care use of the St. Jude~     Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in~     diagnostic and/or interventional radiology patient populations.~   "
178991|NCT01222091|"~     This research study explores whether a beta-blocker can prevent a person from becoming more~     sensitive to pain after administration of an opioid. Beta blockers inhibit the sympathetic~     (fight or flight) response and are often used to treat angina and high blood pressure. In a~     previous study in human volunteers, the investigators demonstrated an increased sensitivity~     to pain after a 60-minute infusion of the opioid remifentanil. The goal of this study is to~     identify a possible inhibitor of this phenomenon.~   "
178992|NCT01222078|"~     The purpose of this study to assess the safety and tolerability of re-dosing at 6 months with~     otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with newly~     diagnosed type 1 diabetes mellitus~   "
178993|NCT01222065|"~     The proposed human clinical studies have three main objectives:~        1. To determine reproducibility of peripapillary birefringence maps and identify features~          that measure the health of the RNFL.~        2. To determine the normal variation in the birefringence maps with age.~        3. To develop and test a classifier for glaucoma based on the birefringence maps using a~          case-control clinical trial.~      This study is a case-control study intended to optimize feature selection for a future~     multi-center blinded study. The proposed clinical study does not measure conversion from~     normal to glaucoma.~   "
178994|NCT01222052|"~     In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The~     identification of this subgroup can be based either on clinical and pathological or on~     tumour-biological criteria. Due to their high prognostic impact, the tumour-biological~     invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1) are~     potential candidates to effectively assess the risk of relapse in node-negative breast~     cancer. This study is aimed to compare the risk assessment by the traditional~     clinico-pathological factors and by tumour-biological factors. The second study question~     refers to the comparison between an adjuvant combination treatment with FE100C*6 and a~     sequential treatment with FE100C*3 and Docetaxel*3.~   "
178995|NCT01222039|"~     The main purpose of this trial is to assess the safety and feasibility of treatment with~     two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro~     in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed~     chronic and extensive graft versus host disease (GVHD).~      Mesenchymal stem cells (MSCs) express low levels of HLA class I molecules, and do not express~     class II molecules neither CD40, CD80 and CD86, being unable to induce proliferation of~     allogeneic lymphocytes. In addition, MSCs inhibit lymphocyte proliferation by inhibiting cell~     division and maintaining these cells in a quiescent state. This supports the hypothesis that~     MSCs are universal suppressors.~   "
178996|NCT01222026|"~     Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated~     with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical~     treatment of pHPT.~      Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or~     osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD~     than placebo treated patients.~   "
178997|NCT01222013|"~     The purpose of this study is to evaluate the efficacy, through molecular response and~     event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM~     like Induction in children with ALL Ph+.~   "
179011|NCT01221831|"~     This is an open-label, multi-centre, comparative study in young, healthy, female volunteers~     of reproductive age.~      Primary objective:~      - To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal~     bleeding patterns (cycle control), in comparison with a combined oral contraceptive~     containing estradiol valerate and dienogest~      Secondary objectives:~        -  To investigate ovulation inhibition~        -  To investigate the effect on SHBG~        -  To assess pregnancy rate~        -  To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight~        -  To investigate return of menstruation after treatment~        -  To evaluate general safety and acceptability~   "
178998|NCT01222000|"~     Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of~     keratinization of the skin which results in a severe generalized cutaneous xerosis with dark~     brown big scales, an ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia.~     They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1~     (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the~     triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the~     cytochrome p450 ( CYP4F2).~      No etiological treatment is available. Symptomatic treatment consists on twice application of~     emollients and keratolytic ointments which decrease the dryness of the skin and reduce~     scales. Oral isotretinoin is usually partially effective but is only suspensive and has~     numerous side effects.~      Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from~     green tea increases the differentiation of the normal human keratinocytes, as showedb by the~     increase of the involucrine, TG1 and caspase-14 genes expression.~      The main objective of this pilot study is to estimate the action and the tolerance of a daily~     application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous~     roughness of patients with lamellar ichthyosis, after 4 weeks of treatment.~      The secondary objectives~        -  To estimate the duration of remission obtained after the treatment~        -  To estimate the action of cutaneous Veregen® to improve the palmar and plantar~          involvement.~        -  To estimate the action of cutaneous Veregen on the pruritus~        -  And to estimate the global level of acceptability by the patient of the Veregen 10 %~   "
178999|NCT01221987|"~     The current study will elucidate the human papillomavirus type distribution in a population~     of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical~     cancer in Sri Lanka.~   "
179000|NCT01221974|"~     The purpose of this study is to gather safety data related to the use of Essure®~     micro-inserts in women with hydrosalpinx prior to in vitro fertilization and during pregnancy~     and to collect data with regard to implantation rates, clinical pregnancy rates, and~     pregnancy outcomes.~   "
179001|NCT01221961|"~     This is a study designed to compare the agreement of hemoglobin (Hb) measurements, documented~     at specific time points (the time a blood sample was obtained by the standard clinical care~     after physician/nurse orders it and, during that same time, the Hb value recorded by the~     Masimo Radical-7 monitor); recorded several times throughout patient's major spine surgery~     procedure (depending on how many times the physician/nurse orders the Hb value to be tested),~     between the standard clinical practice {intermittent measure of Hb [Cedar Sinai Medical~     Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous, non-invasive Hb~     level measurements)*.~   "
179002|NCT01221948|"~     The purpose of this study is to document patient outcomes, including effectiveness, safety,~     and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS)~     Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment~     of moderate to severe idiopathic Parkinson's Disease (PD).~   "
179003|NCT01221935|"~     The goal of this observational study is to learn about how Pristiq is currently being used in~     general practice and how psychiatrists and primary care physicians currently perceive Pristiq~     in terms of efficacy, tolerability, and adherence compared to other treatments for major~     depressive disorder (MDD).~   "
179004|NCT01221922|"~     The purpose of this study is to evaluate the RevLite Q-Switched Neodymium:~     Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types~     (Fitzpatrick Skin Types III, IV, V and VI).~   "
179005|NCT01221909|"~     Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a prospective,~     double blind, placebo controlled study.~      The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding in~     DCR surgery, and might reduce the duration of the surgery.~   "
179006|NCT01221896|"~     The purpose of the study is to determine a possible input of C11-Choline PET/CT in~     identification and localization of a parathyroid adenoma (PTA).~      Preoperative localization of a PTA has been previously documented in multiple series, and is~     usually based on scintigraphy and on US.~      Currently, the conventional technique for localization of a PTA is a dual-isotope scan with~     Tc99m-MIBI and Tc99m pertechnetate. This study is acquired over at least 3 hours, includes~     two i.v. injections and the patient has to stay 15-30 min per acquisition under the camera.~      In addition, there is no anatomical imaging and further correlation with US is usually~     recommended.~      In contrast, PET/CT study with C11-Choline takes as long as 10 min., includes one injection,~     and provides data of higher resolution of functional (PET) and anatomical imaging (CT).~      Furthermore, dosimetric data shows that the total effective dose from Tc99mMIBI and Tc99m~     pertechnetate injection is (without CT): 0.5957 rem; and from C11-Choline injection and CT of~     a chest is: 0.3128 - 0.8628rem.~   "
179007|NCT01221883|"~     PTSD is a pervasive and frequent disorder. Early psychological treatment - but not~     pharmacology - effectively prevent PTSD.~      Current pharmacological studies did not include treatment given immediately after trauma~     exposure.~      However, a recent study of opiates suggests that their early administration may reduce the~     likelihood of developing PTSD - possibly by mitigating early post-traumatic distress (UCR) -~     within an adequate window of time.~      Benzodiazepines are often used to reduce anxiety and agitation during stressful situations -~     including traumatic event.~      These compounds may increase the likelihood of developing PTSD when administered few days~     after the traumatic event - but their effect as an immediate intervention has not been~     studied - despite their frequent and uninformed use at this stage.~      This work will evaluate the effect of diazepam - a BZ compound - on PTSD symptom trajectory~     following traumatic event in a randomized controlled design.~      Following the studies of opiates it is hoped that diazepam, administered within hours of the~     traumatic event, and before the first night sleep (a memory consolidating condition) will~     reduce the likelihood of developing PTSD. However, an adverse effect cannot be excluded, and~     thus the investigators posit a bidirectional hypothesis.~      The importance of this work is that it will provide the necessary evidence to sanction a~     frequently practiced use of benzodiazepines.~   "
179008|NCT01221870|"~     The intravenously administered taxane, paclitaxel, is one of the most commonly employed~     agents for the treatment of both localized and advanced breast cancer.~      Tesetaxel is an orally administered taxane that is in development as first- and second-line~     treatment for patients with advanced cancers. This study is being undertaken to determine the~     efficacy and safety of tesetaxel administered as first-line therapy to patients with~     metastatic breast cancer.~   "
179017|NCT01221753|"~     In this research study, the investigators are studying whether a reduced dose of radiation~     when given with standard doses of chemotherapy can reduce side effects without compromising~     control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck~     is initial chemotherapy followed by radiation and chemotherapy together. This treatment is~     effective but has many immediate and long-term side effects. People who have squamous cell~     carcinoma of the head and neck (SSCHN) that is related to an infection by the human~     papillomavirus (HPV) have been shown to have a high response to this treatment along with a~     high cure rate. The investigators think that by reducing the intensity of this treatment,~     they may be able to reduce immediate and long-term side effects which may lead to long term~     improvements in quality of life and function.~   "
179018|NCT01221740|"~     1. To show that patients with greater pain sensitivity will show greater improvement in~          their symptoms (self-reported pain intensity, mood, sleep, and quality of life) than~          those with lower pain sensitivity, based on QST, after taking milnacipran.~        2. To compare outcome differences (pain intensity, mood, activity interference, sleep, and~          side effects) with those patients who are either taking or not taking opioids for their~          pain 10 weeks after being prescribed milnacipran.~        3. To show that patients who are older, male, with more medical comorbidities, greater~          disability, and longer pain duration will report less improvement (pain, mood, sleep,~          health-related quality of life) and treatment satisfaction while taking milnacipran~          compared with others without such characteristics.~   "
179019|NCT01221727|"~     This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with~     osteoporosis.~   "
179020|NCT01221714|"~     To evaluate the safety and tolerability of two supplements in healthy subjects taken daily~     for six months.~   "
179021|NCT01221701|"~     This study develops and contrasts In-Home Cognitive Behavioral Therapy (IH-CBT), an adapted~     evidence-based treatment for depressed mothers participating in home visitation, with typical~     home visitation in which treatment may be obtained in the community. Mothers will be~     identified using a two step process consisting of administration of a screen and subsequent~     diagnosis of Major Depressive Disorder. The will then be randomized into the treatment and~     control conditions. A comprehensive assessment of depression and related areas of functioning~     will be administered at pre-treatment, post-treatment, and 3 month follow-up. It is~     hypothesized that IH-CBT will lead to broad and durable gains in mood and social support~     relative to those in typical home visitation.~   "
179022|NCT01221688|"~     GANEA 2 is a new trial based on patient treated for a large breast tumor with proven axillary~     involved nodes. Patients enrolled in this trial will have first an axillary sonography with~     fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to~     determine two groups of patients : group 1 : patients with proven involved axillary nodes and~     group 2, patients without proven axillary involved nodes. Patients of group 1, the study~     group, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group~     2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of~     detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last~     group will be followed 5 years in order to evaluate the risk of axillary relapse without~     lymphadenectomy.~   "
179023|NCT01221675|"~     Lung cancer is currently the leading cause of cancer death in both men and women in Europe,~     with an estimated 250000 new cases diagnosed in 2005. The continued poor outcome of patients~     indicates that the current recommended regimens are falling short. In addition, many of the~     commonly used chemotherapy agents are associated with severe nonhematologic toxicities that~     are often cumulative and nonreversible and impair quality of life in this essentially~     palliative setting. Therefore, agents with novel mechanisms of action and superior safety~     profiles need to be investigated. More than 50% of lung cancer shows carcinoembryonic antigen~     (CEA) expression and anti-CEA radioimmunotherapy (RAIT) could be used. The investigators~     group showed that pretargeted RAIT (PRAIT) using bispecific antibody (bsMAb) can deliver a~     higher radiation dose to a tumor than a directly radiolabeled anti-CEA antibody, and shows~     improved anti-tumor efficacy. This clinical trial is designed to assess PRAIT using an~     entirely new recombinant anti-CEA bsMAb and a 177Lu-labeled peptide for the treatment of~     CEA-expressing small cell lung cancers (SCLC) or CEA-expressing Non Small Cell Lung Carcinoma~     (NSCLC)~   "
179024|NCT01221662|"~     Brain hypoperfusion patients may cause vascular dementia results from their hypoperfusion~     state except that is a risk factor for stroke. The most common clinical symptom of~     hypoperfusion syndrome is dizziness.Siwu tang is made of Angelica sinensis (Oliv.) Diels~     (當歸), Rehmannia glutinosa (Gaertn) Libosch (熟地黃), Paeonia lactiflora Pall (白芍), Ligusticum~     chuanxiong Hort (川芎), and that was used to treat patients with blood deficiency for several~     centuries. the purpose of the present study was to investigate the complementary effect of~     siwu tang on brain hypoperfusion syndrome patients~   "
179025|NCT01221649|"~     The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of~     measuring the intrathoracic impedance on a daily basis and transmission of impedance trend~     data via the Home Monitoring technology. In future, this will allow for automatic early~     detection of imminent decompensation at a presymptomatic stage and immediate initialization~     of clinical meaningful therapeutic interventions preventing heart failure (HF) related~     hospitalizations. The aim of this investigation is to record long-term impedance trends in~     heart failure patients with and without heart failure related events (hospitalizations due to~     acute decompensation) in order to develop algorithms for device-based early detection and~     warning of HF deterioration accompanied by pulmonary congestion.~   "
179026|NCT01221636|"~     The purpose of this study is to determine whether the blood levels of abatacept drug product~     manufactured using High Metals and using Low Metals are comparable in healthy subjects.~   "
179082|NCT01220908|"~     The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction~     Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a~     less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as~     an alternative to lung volume reduction surgery, potentially achieving the desired reduction~     in lung volume limiting the risks associated with major surgery, such as illness or death.~     This device is deployed through a bronchoscope and requires no incision.~   "
179027|NCT01221623|"~     This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and~     efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 300 (200 AA4500~     and 100 placebo) men will be randomized. Subjects will be screened for study eligibility~     within 21 days before the initial injection of study drug in the first treatment cycle.~      Before dosing, subjects will be stratified by degree of penile curvature (ie, 30º to 60º or~     61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio either~     AA4500 0.58 mg or placebo.~      In this study, qualified subjects may receive up to four treatment cycles; each cycle will be~     separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will~     receive two injections of study drug with at least 24 hours but not more than 72 hours~     between injections. After the final injection of each treatment cycle, the investigator or~     qualified designee will model the penile plaque in an attempt to stretch or elongate the~     plaque. If the subject's penile curvature is reduced to < 15 degrees after the first, second,~     or third cycle of injections or if the investigator determines further treatment is not~     clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles~     will not be administered.~      Following the maximum of four treatment cycles, each subject will be followed for additional~     safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365~     (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive~     open-label AA4500 treatment after completing this study as part of another protocol.~   "
179028|NCT01221610|"~     A prospective, multi-centre, randomized controlled, First in Man study to assess the safety~     and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an~     uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal~     arteries.~   "
179029|NCT01221597|"~     This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and~     efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 400 (267 AA4500~     and 133 placebo) men will be randomized. Subjects will be screened for study eligibility~     within 21 days before the initial injection of study drug in the first treatment cycle.~      Before dosing, subjects will be stratified by degree of penile curvature deformity (ie, 30º~     to 60º or 61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio~     either AA4500 0.58 mg or placebo.~      In this study, qualified subjects may receive up to four treatment cycles; each cycle will be~     separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will~     receive two injections of study drug with at least 24 hours but not more than 72 hours~     between injections. After the final injection of each treatment cycle, the investigator or~     qualified designee will model the penile plaque in an attempt to stretch or elongate the~     plaque. If the subject's penile curvature is reduced to <15 degrees after the first, second,~     or third cycle of injections or if further treatment is not clinically indicated, subsequent~     treatment cycles will not be administered.~      Following the maximum of four treatment cycles, each subject will be followed for additional~     safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365~     (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive~     open-label AA4500 treatment after completing this study as part of another protocol.~   "
179030|NCT01221584|"~     The purpose of the study is to establish the proportion of patients on lipid-lowering~     pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific~     Cardiology Society guidelines/ the 4th Joint European Task Force guidelines.~   "
179031|NCT01221571|"~     The aim of this study is to determine the safety, tolerability, pharmacokinetics and activity~     of single cycles of AFM13 in patients with CD30 positive refractory and/or relapsed Hodgkin~     lymphoma.~   "
179032|NCT01221558|"~     The hypothesis was that an increase in serum lycopene levels following supplementation with~     capsules containing natural lycopene rich tomato extract would reduce oxidative stress and~     improve endothelial function in healthy men with low intake of fruits and vegetables. A~     randomized double-blind, placebo-controlled study was designed to assess the changes in serum~     lycopene levels, oxidative stress and endothelial function in response to an 8-week treatment~     with lycopene supplementation.~   "
179033|NCT01221545|"~     The purpose of this study is to investigate safety and tolerability after high Single~     Ascending Oral Doses of AZD1656.~   "
179034|NCT01221532|"~     The investigators will randomize 700 non-psychiatric, non-obstetric, non-surgical patients~     aged 55 years and older at San Francisco General Hospital (SFGH) to usual care (ten days of~     prescription medication, discharge summary sent to primary care provider (PCP), and~     outpatient appt made for patient, and patient's nurse reviews discharge plan,) or usual care~     plus a peridischarge intervention (a visit with specialized in-hospital discharge nurse,~     development of personalized discharge plan, two phone calls from a nurse~     practitioner(NP)/physician assistant (PA) after discharge and availability of additional~     calls back from NP/PA, upon patient request, to help answer questions and assist patient's~     transition to outpatient care, and communication with primary care/subspecialty providers).~     The usual care and usual care plus intervention groups will be assessed for differences in~     mortality and rates of rehospitalization and emergency department use 30, 90 and 180 days~     following discharge from the hospital.~      The discharge process from the hospital to home is frequently marked by poor quality and high~     risk of adverse events and readmissions. It has been hypothesized that better coordinated~     care, personalized patient education, and follow-up calls to identify potential sources of~     adverse events, such as medical complications and medication errors can reduce~     rehospitalization and emergency room visits following discharge from the hospital. Although~     these interventions have been shown to reduce combined hospital readmissions and emergency~     department visits in English-speaking patients, none has focused on elderly patients in a~     diverse urban public hospital setting that includes non-English-speakers, who might benefit~     more than other populations from enhanced services during and after discharge from the~     hospital. Further, these labor-intensive interventions are costly to implement, and it is~     unknown whether opportunity cost of providing additional services in a limited-resource~     environment such as San Francisco General Hospital (SFGH) outweighs the unknown clinical~     benefits.~   "
179035|NCT01221519|"~     The purpose of this study is to assess the relative bioavailability by measuring the extent~     and rate of absorption of different tablet formulations of AZD1656 in T2DM patients.~   "
179036|NCT01221506|"~     All patients who participate in this study will receive pazopanib. Pazopanib is an oral drug~     (pill) that has been approved by the U.S. Food and Drug Administration (FDA) for the~     treatment of advanced kidney cancer. In this study, the investigators plan to learn more~     about the way this drug works by using special scans (MRIs and Ultrasounds) to help evaluate~     how this drug is working on this disease. Approximately 20 people with advanced kidney cancer~     will be enrolled on this study.~   "
179037|NCT01221493|"~     To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral~     lung lesions~   "
179038|NCT01221480|"~     The aim of this observational study is to utilise the established record linkage data~     available in Tayside to investigate hospital admissions, exacerbations and mortality in COPD.~   "
179039|NCT01221467|"~     Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring~     life-long insulin therapy. Children and adolescents with T1D need regular insulin injections~     or the continuous insulin delivery using an insulin pump in order to keep blood glucose~     levels normal. The investigators know that keeping blood sugars in the normal range will help~     prevent long-term diabetes-related complications involving the eyes, kidneys and heart.~     However, achieving treatment goals can be very difficult as the tighter the investigators try~     to control blood glucose levels, the greater the risk to develop symptoms and signs of low~     glucose levels (hypoglycaemia). This is a particular problem at night and one solution is to~     develop a system whereby the amount of insulin injected is controlled by a computer and is~     very closely matched to the blood sugar levels on a continuous basis. This can be achieved by~     what is known as a closed-loop system where a small glucose sensor placed under the skin~     communicates with a computer containing an algorithm that drives an insulin pump. The~     investigators have been testing such a system in Cambridge over the last three years in~     children and have found that this system is effective at preventing nocturnal hypoglycaemia.~     The next stage of this research is to test the system for a longer period of time at home. In~     the present study the investigators are planning to study 16 adolescents aged 12-18 years on~     insulin pump therapy. During 21 nights glucose will be controlled by the computer and during~     the other 21 nights the subjects will make their own adjustments to the insulin therapy. The~     investigators will then analyze the data to determine the effect of the computer algorithm in~     keeping glucose levels between 3.9 and 8 mmol/L (normal levels) and reducing the time they~     spent with glucose below 3.9 mmol/L (hypoglycaemia). Subjects' response to the use of the~     system in terms of life-style change, daily diabetes management and fear of hypoglycaemia~     will be assessed. The investigators will also test for longer term glucose control by~     measuring glycated haemoglobin and other blood parameters.~   "
179040|NCT01221454|"~     The purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow~     stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B~     infection. The evaluation of the efficacy includes the level of serum alanine~     aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin~     time (PT), albumin (ALB), prealbumin(PA), liver histological improvement before and 1 week to~     1 year after transplantation. Child-Pugh scores, MELD scores and clinical symptoms were also~     observed simultaneously.~   "
179041|NCT01221441|"~     The purpose of this study is to see if we can safely regenerate cartilage without invasive~     surgery using a biologic product called TissueGene-C.~   "
179042|NCT01221428|"~     The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of~     treatment for ulcerative colitis is safe and effective.~   "
179043|NCT01221415|"~     The primary objective of this study is to compare ultrasound versus nerve stimulator~     techniques for nerve localization when performing peripheral nerve blocks. Specifically the~     investigators will be performing Popliteal, Femoral, and Interscalene nerve blocks. The~     investigators will be looking for differences in 1) time taken to locate the target nerve and~     inject local anesthetic 2) time from injection of local anesthetic to adequate surgical~     anesthesia 3) effectiveness of block 4) incidence of vascular puncture 5) incidence of~     adverse events 6) patient satisfaction.~   "
179044|NCT01221402|"~     Intermediate saphenous vein graft (SVG) lesions are common, have high rates of progression to~     severe lesions or occlusion, and are associated with high incidence of adverse clinical~     outcomes.~      The ALPINE-SVG trial is a randomized-controlled trial of extended-release niacin vs. placebo~     in patients with intermediate saphenous vein graft lesions. The main hypothesis of the study~     is that compared to placebo, niacin administration will result in reduction in percent~     atheroma volume at 12-month follow-up angiography.~   "
179045|NCT01221389|"~     Information on the management of casualties from the ongoing conflicts in Afghanistan and~     Iraq has brought in to question the traditional approach to blood transfusion in hemorrhaging~     patients. Present recommendations for when to transfuse plasma products is when coagulation~     tests become abnormal. The proposed trial will investigate whether the more aggressive plasma~     transfusion strategies as advocated from researchers based on the Central Asian conflicts is~     valid. Since a study to determine the full impact of an altered plasma transfusion practice~     would require thousands of patients, a feasibility trial is appropriate and is being~     proposed. The hypotheses are thus:~      Primary Hypothesis- A multicentre trial that investigates the earlier use of plasma in~     patients with hemorrhagic shock going for emergency surgery will be feasible.~      Secondary Hypotheses- The early use of a universal donor blood plasma (AB+ plasma) in~     patients with shock due to blood loss (i.e. hemorrhagic) going for emergency surgery will~     reduce overall exposure to the total number of blood donor products (so-called allogeneic~     blood exposure). A reduction in allogeneic blood exposure would then reduce the total number~     of blood transfusion-related complications. The early use of this plasma product is safe and~     will not increase the incidence of blood clotting or other transfusion-related complications.~   "
179046|NCT01221376|"~     The purpose of this study is to evaluate the hematological, cytogenetic and molecular~     response to continuous-use of Imatinib in children with CML Ph+.~   "
179047|NCT01221363|"~     Recent studies have suggested that prolonged daily sitting time may in itself have a negative~     effect on health, even in people who engage in daily physical activity.~      The aim of the present study is to explore whether individually tailored lifestyle~     counselling aimed at reducing TV-viewing and other sedentary activities during leisure time~     and at work, can reduce sitting time and waist circumference, weight and blood pressure; and~     improve serum lipid levels. From a population-based health survey, 150 adult men and women~     with more than 3.5 hours of daily leisure time sitting time are recruited and randomly~     assigned to 1) an intervention group or 2) a control group. The intervention group will~     participate in 4 individually tailored lifestyle intervention sessions focussing on reduction~     of daily sitting time. The control group will receive no intervention.~   "
179048|NCT01221350|"~     The aim of the study is to use the antioxidant and antiinflammatory effects of lipoic acid to~     improve the quality of life of patients with asthma.~      The investigators will administrate 600 mg lipoic acid orally on a daily basis during two~     months concurrent with the patient anti-asthmatic therapy and evaluate the effects on~     resulting pulmonary function, inflammatory and oxidative stress biomarkers and health-related~     quality of life previous to the initial of the treatment and at 60 days of the supplementary~     therapy.~   "
179083|NCT01220895|"~     The purpose of this study is to evaluate the potential clinical benefit of pre-emptive~     cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic~     hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.~   "
179086|NCT01220856|"~     Inhibition of CXCL8 activity might represent a relevant therapeutic target to prevent injury~     occurring after pancreatic islet transplantation. Reparixin is a novel and specific inhibitor~     of CXCL8. This study is designed to explore the efficacy of reparixin in preventing graft~     dysfunction after islet transplantation in type 1 diabetes patients (T1D).~   "
179049|NCT01221337|"~     The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal~     circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy~     during a haemodialysis session. In the cases of multiple coagulation defects having high~     haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended~     to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low~     heparin or heparin free haemodialysis have been proposed till now, without a real success.~     The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 %~     successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated~     polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic~     properties and a capacity to improve the haemorrheological factors of human blood, hence~     having a promising future to perform a successful haemodialysis session with less or without~     heparin. This randomised, multi-centric, cross-over and open study has been designed to~     compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5%~     and an absolute accepted difference of 12 %.~   "
179050|NCT01221324|"~     Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive~     protein (CRP) and white blood cell counts (WBC) in the postoperative course. The aim of this~     study was to evaluate the diagnostic accuracy of CRP and WBC for postoperative inflammatory~     complications after open resection of colorectal cancer.~   "
179051|NCT01221311|"~     The current standard of care for benign bile duct strictures involves placement of multiple~     plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch~     it open. This approach necessitates multiple procedures which may extend over one year before~     the stricture is adequately dilated. The investigators propose a study comparing the standard~     approach of plastic stenting with the use of newer, fully coated metallic stents which are~     self-expandable, thereby permitting successful dilation of benign bile duct strictures with~     fewer procedures.~   "
179052|NCT01221298|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072~     and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus~     (HCV) infection.~   "
179053|NCT01221285|"~     This trial is a biomarker-based pilot study of the safety of Cockroach Subcutaneous~     Immunotherapy in Cockroach-sensitive Adults (SCITCO) who have a history of perennial allergic~     rhinitis, asthma, or both.~   "
179054|NCT01221272|"~     This study enrolled participants with documented exercise-induced myocardial ischemia in~     order to evaluate whether ranolazine, when taken prior to exercise, can improve blood flow to~     the heart (myocardial perfusion), as assessed by exercise-induced myocardial perfusion defect~     size (PDS) and total perfusion deficit (TPD), using gated single photon emission computed~     tomography (SPECT) myocardial perfusion imaging (MPI).~      This was a 2-period crossover study. The last dose of each period must have been taken 3-4~     hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI was~     performed at the end of Period 1, participants discontinued the treatment they were~     randomized to for that period and began the other treatment in Period 2.~   "
179055|NCT01221259|"~     This study is designed as a single ascending dose study in healthy subjects to evaluate~     safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) in plasma and~     Cerebrospinal (CSF) following single oral doses of E2212.~   "
179056|NCT01221246|"~     The purpose of this research study is to determine whether the investigational drug GM602, is~     effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot~     blocking the flow of blood through one, or more of the blood vessels supplying the brain)~     when administered up to 18 hours after symptoms begin.~   "
179057|NCT01221233|"~     Rehabilitative Ultrasound Imaging (US) is a procedure used to evaluate skeletal muscle size~     and function to inform clinical practice. US has been shown to be a reliable and valid tool~     for measuring changes in trunk muscle (i.e. abdominal and back muscle) size and activity~     during sub-maximal contractions in younger populations. Younger adults with low back pain as~     compared with healthy adults without pain demonstrate smaller back muscle size, lower back~     muscle activity, and greater back muscle asymmetry (differences in right side compared with~     left side).~      No trials are published evaluating muscle adaptations using US in response to clinical~     treatments for low back pain in the older adult population. Increased muscle size and~     improved muscle symmetry have been reported in younger adults with low back pain who~     participate in low back stabilization exercises. These exercises use voluntary contractions~     of the back muscles with prolonged hold times and low loads. Neuromuscular Electrical~     Stimulation (NMES) is a treatment modality that increases muscle activity when voluntary~     activity is impaired and increases muscle size. Most studies assessing muscle size and~     activity in response to NMES have been conducted in the knee muscles (i.e. the quadriceps),~     while the impact of NMES on the back muscles remains relatively unexplored. Given the~     potential to evaluate back muscle size and activity with US, this assessment tool may be used~     to document muscle adaptations to a clinical intervention in older adults with low back pain.~      The purpose of this study is to conduct a 6-week clinical trial to determine if NMES plus~     lumbar stabilization exercises is superior to lumbar stabilization exercises for improving~     back muscle size, activity, and side-to-side (i.e. right side versus left side) symmetry in~     older adults with chronic low back pain (i.e. low back pain of greater than 3 months). Muscle~     size, activity, and symmetry will be assessed using US before and after the treatments to~     determine if the treatments positively impact muscle. Secondary clinical measures of success~     will include improvements in physical, psychological, and social function pre- to~     post-treatment.~   "
179058|NCT01221220|"~     There is a need for effective weight control methods for obese children. Environmental~     strategies such as reducing the size of dishware and serving utensils, storing food out of~     view and reducing food consumption while watching television may reduce food intake without~     requiring conscious, cognitive self-control. The investigators propose to test these methods~     when added to a current state-of-the-art behavioral program.~   "
179059|NCT01221207|"~     Aim 1. To compare the effectiveness of total contact casts (TCC), removable cast walkers~     (RCW) and instant total contact casts (ITCC) to heal diabetic foot ulcers in a 20 week~     randomized clinical trial of 225 patients in community care in three university medical~     center diabetes clinics.~      Aim 2. To compare the frequency of complications such as soft tissue and bone infections,~     iatrogenic wounds, falls and fall related injuries, and amputations among patients treated~     with TCC, ITCC and RCW to heal diabetic foot ulcers.~      Aim 3. To compare patient compliance and level of activity among TCC, ITCC, RCW treatment~     groups. Using computerized activity monitors which time-stamp each step, we will evaluate~     both degree and magnitude of activity between groups.~      Aim 4. To evaluate the cost of diabetic foot ulcer-related treatment and complications during~     the course of therapy.~   "
179060|NCT01221194|"~     1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings,~          PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.~        2. To evaluate perceived health-related quality of life as compared to guideline directed~          usual care in patients who use the PFC stockings.~   "
179061|NCT01221181|"~     This is an open label, non-blinded, proof of concept efficacy and safety study of eculizumab~     in patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult~     patients with these diseases who have > 1 gram of proteinuria or a decreased glomerular~     filtration rate (GFR), both predictors of a poor long-term outcome in many glomerular~     diseases. They will be treated with eculizumab for one year. The goals will be to determine~     whether treatment leads to an improvement in kidney function, defined by remissions of~     proteinuria and improvements in estimated GFR (measured by serum creatinine), and to~     improvement in histologic parameters, including percentage of non-affected glomeruli,~     interstitial fibrosis, intensity of C3 staining of immunofluorescence, and amount of electron~     dense deposits by electron microscopy.~      All enrolled subjects will receive eculizumab treatment for one year. There will be 29 study~     visits over 53 weeks. The goal is to determine whether this treatment will improve kidney~     function, as evidenced by less protein in the urine and improved lab results.~      An EXTENSION TREATMENT PHASE has been added. After completing the study, patients are~     followed with labs every four weeks as per standard of care. If labs suggest a relapse, they~     will be allowed to continue on therapy at the previous dosage until this drug receives FDA~     approval for this indication. Treatment intervals and dosage are identical to the original~     study.~   "
179062|NCT01221168|"~     The aims of the study are:~        -  to identify genetic and molecular factors (rare mutations, polymorphisms) involved in~          the natural history of prostate cancers and their response to treatment,~        -  to evaluate and deduce their medical applications for screening and therapeutic~          management of these tumors.~   "
179063|NCT01221155|"~     Manual treatment offers benefit to some patients suffering from back pain but little is known~     about which of the many tissue layers are affected. This study will help identify which~     tissues may be stimulated sufficiently to be a source for the clinical effects of treatment~     and to prioritize future work to understand mechanisms of back pain and to improve care.~      Current soft-tissue ultrasound elastography techniques, under static condition, will be~     extended to quantify relative displacement and strains(active and passive)across the depth of~     tissue strata that arise from small amplitude motions during continuous passive motion~     clinical procedures and in weight bearing postures. Relative movement of the stratified~     layers of the back, from treatment and task-generated perturbations, will enable the~     elastography interrogation of the tissue.~   "
179064|NCT01221142|"~     In this pilot study the researchers will investigate efficacy of hypothermia in the early~     stage of treatment patients with primary intracerebral hemorrhage.~   "
179065|NCT01221129|"~     The specific aim of this protocol is to examine differential expression of specific mRNAs and~     proteins that occur when the dietary intake of zinc is acutely reduced below the dietary~     requirement for a period of ten days.~   "
179066|NCT01221116|"~     Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics~     after cardiac surgery and lead to reduced stay at intensive care unit~   "
179067|NCT01221103|"~     The rationale for this study design is based on the fact that the maximum tolerated dose~     (MTD) of single-agent ofatumumab and bendamustine have been previously determined. The choice~     of the doses for the combination is based on the investigators unpublished clinical~     experience, as well as inferred from extensive experimental data on the use of other~     monoclonal antibodies in combination chemotherapy in lymphoma patients. The starting dose of~     the 2 main component drugs is the MTD of each drug as single agent.~   "
179068|NCT01221090|"~     To evaluate the effectiveness of two different diabetes self-management approaches (Personal~     Digital Assistant-based intervention & Chronic Disease Self-Management Program) to reduce~     health disparities in minority, rural residents, and other underserved populations with type~     2 diabetes in Central Texas. We hypothesise that: 1) Racial/ethnic minority patients with~     T2DM will be found to experience disparities in diabetes self-management treatment protocols~     and clinical outcomes, which persist even when controlling for age, gender, obesity, and~     insurance status; 2) Patients with T2DM who reside in more rural areas will be found to~     experience disparities in diabetes self-management treatment protocols and clinical outcomes~     as compared to more urban counterparts, controlling for age, gender, race/ethnicity, obesity,~     and insurance status; 3) The introduction of CSDMP and HIT protocols will improve~     diabetes-related self management behaviors, reduce HBA1c values, and increase quality of life~     in persons with T2DM as compared to controls. A combined intervention approach will result in~     the greatest reductions; 4) Health improvements following the introduction of CDSMP, HIT or~     CDSMP/HIT protocols in persons with T2DM compared to controls will be more marked in~     racial/ethnic minority patients and those patients residing in rural areas; 5) The~     introduction of self-management interventions will be cost-effective in reducing HbA1c values~     over time, and associated health care utilization including overall reduction in ER and acute~     care hospital admissions; 6) Although there is little prior research in this area to guide~     specific hypotheses, we hypothesize that, overall, there will be no significant~     cost-effective differential in CDSMP as compared to HIT approaches, although the~     cost-effective ratio may be stronger in particular subpopulations. The combined approach will~     have higher costs, but is also anticipated to have a higher cost-benefit ratio for minority~     populations; 7) The majority of clinicians will be willing to let their patients enroll in~     the study and will reinforce intervention protocols; and 8) These interventions can be~     embedded into existing health care structures. At the end of the study, Scott and White will~     institutionalize cost-effective treatment protocols.~   "
179069|NCT01221077|"~     A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib~     (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer~     (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are~     Chemonaive.~   "
179070|NCT01221064|"~     The aim of the study is to assess whether early drainage removal in patients with less than~     150ml of lymph in postoperative day 1 can reduce total lymphorrhoea~   "
179071|NCT01221051|"~     The purpose with this study was to compare blood loss and women's experience of afterpains~     during the third stage when handled with active or expectant management of the third stage of~     labour.~      Hypothesis 1. To detect a 5% difference (15% vs 10%) in blood loss >1000 mL between the two~     groups with 80% power (α=0.05), at least 726 subjects were required in each group.~      Hypothesis 2. Afterpains are more pronounced in active compared to expectant management~     during the third stage of labour~   "
179072|NCT01221038|"~     Background:~      Heat stroke is defined as a condition where the body temperature raises to dangerous level~     that may cause harm to body tissues and lead to multi-system clinical and pathological~     manifestations that might lead to death. Among heat stroke survivors a defect in~     thermoregulation develops as a consequence. In the IDF, every soldier who had a heat stroke,~     or is suspected to have had a heat stroke, must pass a heat intolerance test in the Unit of~     Military Physiology, after a rest period of 4-6 from the incident, which is the approximate~     period for thermoregulation to recuperate from the injury after a heat stroke. Until the heat~     intolerance test, the soldier must not train to avoid a repeat incident of heat stroke. The~     soldiers' ability to return to active duty is based on the results of the exam. The heat~     tolerance test and its criteria have been developed in the Physiology Unit throughout years~     of experience, and have been proved and adopted by several labs in Europe and in the United~     States. The criteria generally include baseline temperature and heart rate, and are based~     upon the physiological response of healthy men (soldiers) in the physical effort involved in~     the test.In recent years there is a growing trend in the IDF to integrate female soldiers in~     combat divisions. As a result, these females are exposed to physical efforts in various~     climate conditions as a part of their training, or a part of their active duty missions in~     the division. Therefore, the probability of an incidence of heat injuries increases among~     these soldiers.Research results indicate differences in the efficiency of thermoregulation~     mechanisms between men and women:~      It has been found that in women the threshold for sweating and vasodilatation is higher than~     in males. Additionally, although in women the mechanism for sweating is slower, and occurs at~     a later period, it is found that the relative part of sweating that evaporates is higher, so~     that women evaporate sweat more efficiently (to make up for the lower sweat quantities~     compared to men). Reduced efficiency of the thermoregulation mechanisms in women is also~     attributed to the differences in mass, body composition (fat and muscle mass), and physical~     fitness between the genders. In addition, the physiological changes that occur during the~     different phases of the menstrual cycle can affect core temperature at rest and~     thermoregulation. Different reports in literature indicate a decreased thermoregulation~     capacity in the luteal phase of the menstrual cycle compared to the follicular phase.~     Apparently, thermoregulation capabilities in exercise are linked to progesterone blood~     levels, which are influenced by contraceptive pills and with the phase of the menstrual~     cycle.~      There are two factors that can cause incorrect diagnosis of the level of heat tolerance in~     females when the specific test is interpreted based on set criteria for men. These criteria~     are:~        1. The physiological differences between men and women~        2. The differences in women based on menstrual cycle and using contraceptive pills.~      Thus, there is a need to characterize and establish the normal values in a heat tolerance~     test for young females compared to males, and also to correspond to current menstrual cycle~     phase and use of contraceptive pills.~      Methods:~      on the first day of the research, the participants will undergo anthropometric examinations~     (measuring height, weight, BMI, fat content, maximum oxygen consumption). In addition, the~     participants will undergo a heat tolerance test protocol. The heat tolerance test will be~     conducted twice in every participant - once in the follicular phase of the menstrual cycle,~     and a second time in the luteal phase of the cycle. During the protocol, the following~     information will be collected from each participant: heart rate, core temperature, skin~     temperature in three locations (chest, arm, and leg), oxygen consumption and liquid balance.~      The results of the examination will be compared to results of male participants who have~     previously undergone the heat tolerance test in the Unit of Military Physiology.~      Contribution to IDF:~      the research will allow administrating heat tolerance tests accurately and reliably to female~     soldiers that have been affected by heat injuries or are suspected to be heat intolerant.~   "
179084|NCT01220882|"~     This study is being done for two reasons: 1) to evaluate growth problems in the hip in~     patients with Slipped Capital Femoral Epiphysis (SCFE) as they continue to grow into adults,~     and 2) to help doctors determine which patients are at risk for developing a SCFE on their~     opposite hip. Studies show that up to 60% of patients with a SCFE will go on to develop a~     SCFE on their other side. Being able to better determine which patients are at risk for~     developing a SCFE on the other side will help physicians better monitor patients with a~     history of a SCFE and perhaps treat them before they develop a SCFE on the opposite side. By~     studying the growth centers seen on X-rays of your child's legs and elbow, the investigators~     may be able to better predict which children with a SCFE are at risk for developing a SCFE on~     their opposite hip and potential growth problems as they continue to grow.~   "
179073|NCT01221025|"~     This prospective, double blind, placebo-controlled, parallel group study will be conducted in~     three study centers in Guangzhou, China. Patients aged older than 65 (ASA I-III) undergoing~     primary elective abdominal surgery with general anesthesia will be involved in this study.~     According to previous studies and our pilot trial, the sample size was estimated to be 900~     subjects (each center recruiting 300 patients). All eligible patients will be randomly~     assigned to one of two groups: study group receiving parecoxib and control group receiving~     normal saline. All patients will be managed with by a standard clinical anesthesia protocol~     with a sevoflurane-based general anesthesia with continuous intravenous remifentanil,~     followed by a postoperative PCA with morphine. The emergence delirium will be evaluated by~     two persons blinding to medication and grouping using Riker sedation-agitation scale~     immediately since tracheal extubation and at specific time points until patients being~     discharged from PACU. Pain intensity assessments and pain relief assessments will also be~     conducted by the patients at given time points in 2 days postoperatively. The~     morphine-sparing effect, tolerability and safety of parecoxib will be investigated as well.~   "
179074|NCT01221012|"~     Current protective clothing of any kind, especially the nuclear-biological-chemical (NBC)~     protective garments, amplify thermal stress because of the inherent properties of the~     clothing material. High insulation coefficient and low water vapor permeability of the~     protective cloth limit the ability of sweat to readily evaporate, which consequently result~     with a significant elevation of body temperature and with excessive body fluid loss (because~     of inefficient sweating) that might result with significant dehydration.~      Combat soldiers require to perform intense physical activities under hostile environmental~     conditions, including in contaminated areas that need the use of protective garments. The~     ability to fulfill a mission derives from the soldier's professionalism and from his~     physiological limits. It is well established that wearing protective garments affect~     tolerance time (TT) and performance.~      To operate in contaminated areas suitable protective garments should be worn. The inherent~     characteristics of the current protective garments limit, however, the effective working~     periods with such an ensemble, which is further aggravated in hot climate. Thus, in an~     attempt to increase TT and enhance work effectiveness, improved protective garments, which~     result with a lessened heat-stress, are under different stages of development.~      The relative influence of air permeability properties, garment weight and garment~     construction on heat stress and physiological strain will be investigated.~      The results will be quantified in terms of body temperatures, heart rate, fluid balance,~     subjective sensation and the maximum wear time (if necessary extrapolated).~   "
179075|NCT01220999|"~     This is a clinical trial of CS-1008 which is a humanized monoclonal antibody.~      This trial explores where CS-1008 distributes in the body, and the activity of CS-1008 in~     patients with metastatic colorectal cancer. The purpose of this study is to give patients~     with metastatic colorectal cancer a series of different CS-1008 antibody doses in order to:~        -  Study how the dose of CS-1008 effects where the CS-1008 distributes in the body~          (biodistribution), how long it circulates in blood (pharmacokinetics) and how much~          attaches to tumour (tumour uptake). These issues are studied after the initial infusion~          of 111In-CS-1008 (CS-1008 tagged with a small amount of radioactive Indium - also called~          Indium-111 or 111In), and also during and after a cycle of weekly infusions of CS-1008~          antibody.~        -  Study changes in the function (metabolism) of tumour cells following CS-1008~          administration.~        -  Assess whether repeat doses of CS-1008 cause shrinkage of the tumour.~        -  Study whether experimental treatment with CS-1008 changes chemicals in the blood that~          may indicate tumour cell death (serum apoptosis biomarkers) and/or tumour response to~          treatment (serum tumour biomarkers (CEA - carcinoembryonic antigen)).~   "
179076|NCT01220986|"~     The aim of this study is to characterize Kupffer cell activity and activation of the innate~     immune response in the early phase of liver regeneration after right hepatectomy. The~     investigators hypothesise that liver regeneration after right hepatectomy in humans is~     associated with Kupffer cell activation and initiation of the innate immune response and that~     impaired liver regeneration, liver failure and sepsis following liver resection are~     associated with Kupffer cell dysfunction and an impaired innate immune response. The~     objectives for this study are to characterise Kupffer cell activity and the innate immune~     response in human liver before and after right hepatectomy.~   "
179077|NCT01220973|"~     RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving atorvastatin calcium together with~     celecoxib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with~     celecoxib works in treating patients with rising PSA levels after local therapy for prostate~     cancer.~   "
179078|NCT01220960|"~     As studies continue to debate the effects of quality of life on survival, increased attention~     is being focused on investigating complementary alternative therapies to boost overall total~     health in cancer patients . Art therapy is an interesting growing field, which has shown~     promise to positively influence quality of life in the pediatric and adult oncology~     population alike. As there is a paucity of well controlled complete studies in this field,~     the investigators propose to study the impact of art therapy sessions in women with breast~     cancer with quantitative and qualitative analysis of emotional health and physical symptoms.~      The results of the investigators study will have widespread applicability to oncology~     programs that wish to offer/implement such sessions to their palliative and non-palliative~     outpatients in an effort to address the important concept of whole person care.~   "
179079|NCT01220947|"~     This randomized, open-label, active-controlled, parallel-group study will evaluate the~     sustained virological response of danoprevir boosted with low dose ritonavir in combination~     with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in~     treatment-naive patients with chronic Hepatitis C.~   "
179080|NCT01220934|"~     This observational, multicenter study will assess the efficacy and safety of Herceptin~     (trastuzumab) in routine clinical practice in patients with HER2-positive advanced~     adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be~     collected for approximately 12 months.~   "
179081|NCT01220921|"~     The creation of a multi-center cooperative research group encompassing academic and~     community-based spinal practices . . .~   "
179085|NCT01220869|"~     A phase III trial investigating the efficacy and safety of degarelix one-month depot in~     Taiwanese patients with prostate cancer.~   "
179087|NCT01220843|"~     The purpose of this study is to evaluate in Chronic Kidney Disease (CKD) patients not on~     dialysis and who have an Fibroblast growth factor 23 (FGF23) serum levels elevated, the~     effect of non calcic phosphate binder: sevelamer carbonate. This treatment could lead to a~     diminution of FGF23 serum levels due to the diminution of intestinal absorption of dietary~     phosphate. In addition, the investigators will describe the impact of the FGF23 level~     monitoring on the main phosphocalcium metabolism markers as phosphatemia, intact parathyroid~     hormone (iPTH), serum calcitriol and phosphaturia.~   "
179088|NCT01220830|"~     The purpose of the study is to evaluate the efficacy of RFQMR therapy in remyelination in~     cases of Multiple sclerosis.~      The evaluation will be done based on MRI findings, by clinical/ neurological examination and~     by assessment of quality of life before and after completion of therapy.~   "
179089|NCT01220817|"~     When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is~     effective in slowing the rise of PSA as measured by PSA doubling time in men following~     initial therapy for prostate cancer. Further, the investigators believe that POMx will be~     shown to be safe and well tolerated.~   "
179090|NCT01220804|"~     The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in~     diabetic retinas using a novel non-invasive approach based on the Fourier domain~     high-definition optical coherence tomograph (OCT).~   "
179091|NCT01220791|"~     Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently~     control late follicular progesterone rise during IVF treatment~   "
179092|NCT01220778|"~     Background: It is now generally accepted that an active lifestyle is beneficial for~     cognition, but can these benefits be transmitted for the active pregnant woman to her unborn~     child? This has been demonstrated in rats where the pups born of mothers who exercised during~     pregnancy had increased hippocampal neurogenesis and better memory and learning capabilities.~     Human studies tend to confirm this by looking at behavioral results, ie. better orientation~     and state regulation skills in newborns. The aim of the present study is to verify this on~     the electrophysiological level and to determine the effects of an active lifestyle during~     pregnancy on the newborn's brain development.~      Methods: 60 pregnant women will be included in a randomized controlled trial. The exercise~     group will be asked to exercise a minimum of 20 minutes, 3 times per week, at a minimal~     intensity of 55% of their maximal aerobic capacity. The control group will not be given~     exercise counselling. Newborns' brain activity will be recorded using electroencephalography~     (EEG) 10 days post partum. The primary outcome measure will be the amplitude and latency of~     the mismatch negativity (MMN), a component of the auditory event-related potential (ERP) that~     can be used to investigate the auditory sensory memory.~   "
179093|NCT01220765|"~     Rationale: The current standard of respiratory monitoring for patients during deep sedation~     is continuous pulse oximetry with visual assessment of the patient. Clinical research has~     demonstrated that depressed respiratory activity is a principal risk factor for hypoxemia~     during sedation. Capnography may provide early detection of alveolar hypoventilation before~     hypoxemia has occurred in nonintubated patients and thereby improve patient safety during~     sedation.~      Objective: At the Centre for Contraception, Sexuality and Abortion Leiden, abortion~     procedures are performed under deep sedation using propofol. Patient's monitoring is~     performed by nurses qualified in patient sedation management, using pulse oximetry and their~     clinical judgement. The aim of this study is to examine the effectiveness of capnography in~     early detection of alveolar hypoventilation during deep sedation in comparison to standard~     monitoring with pulse oximetry in abortion procedures.~      Study design: This protocol describes a prospective, open, randomized controlled trial with~     two study arms. All patients receive standard care of monitoring performed by the medical~     staff. The study investigates whether capnography prevents patients from having respiratory~     events during deep sedation in abortion procedures by early detection and therapy. Patients~     randomized to the standard care group receive standard of respiratory monitoring using pulse~     oximetry. In the capnography arm, respiratory monitoring is performed with pulse oximetry and~     capnography.~      Study population: The study population comprises female patients (≥ 18 years) undergoing~     abortion procedures during first or second trimester pregnancies. Abortion procedures are~     performed until 22 weeks of gestational age.~      Capnography: In addition application of capnography during deep sedation with propofol is~     performed. Before the trial starts, all nurses qualified in patient sedation management and~     abortion doctors will be trained in assessment of capnography. In the capnography arm,~     patients' breathing is additionally monitored with capnography. If alveolar hypoventilation~     is detected medical staff will intervene by arousing the patient, performing chin lift,~     repositioning the head, provision of oxygen, or abandon from giving additional propofol.~     These interventions represent the standard of care currently used by the clinical staff to~     respond to hypoventilation and hypoxemia.~      Main study parameters/endpoints: The primary outcome is the occurrence of oxygen saturations~     to ≤90% in the population, as measured by continuous pulse oximetry. Secondary study outcomes~     include occurrence of oxygen saturations < 80%, dose of administered propofol, arousal or~     movement of the patient during the procedure, airway interventions, early termination of the~     procedure due to respiratory problems, episodes of bradycardia, and administration of~     atropine.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The risks related to the conduct of this study are negligible and the burden~     minimal. Patients in both groups receive the current standard of care. Patients randomized in~     the capnography group could get benefit from the addition of capnography to the monitoring by~     early detection of alveolar hypoventilation. Capnography is a noninvasive measurement by~     means of a cannula under the nose, which before the sedation may tickle, but during sedation~     no inconvenience is expected.~   "
179094|NCT01220752|"~     The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity and~     efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and~     carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local~     control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial~     includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal~     malignancies.~   "
179095|NCT01220739|"~     To assess the safety and preliminary efficacy of combining intravenous rt-PA with~     transcranial laser therapy (TLT) with the NeuroThera® Laser System (referred to hereafter as~     NTS) in subjects treated for acute ischemic stroke. Treatment with IV rt-PA must begin within~     3 hours of symptom onset, and the initiation of TLT procedure must be feasible for each~     subject within 6 hours of stroke onset. The NeuroThera® Laser System is an investigational~     device that provides noninvasive transcranial laser therapy to subjects diagnosed with acute~     ischemic stroke. The wavelength of the laser light is in the infrared zone of the~     electromagnetic spectrum and is invisible to the naked eye.~   "
179096|NCT01220726|"~     This is a prospective, randomized, double-blind study comparing intravesical injection of~     BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following~     treatment groups:~      Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0),~     subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study~     duration is approximately 284 days and consists of a Screening Visit (Day -7 to -14), a~     Treatment/Randomization Visit (Visit 2, Day 0), and Follow-up Visits at 7, 30, 90, 180, and~     270 Days. Telephone Follow-ups will be made 3 days following the injection cycle.~      Subjects demonstrating an insufficient response to treatment may receive an open-label~     injection cycle of BOTOX (200U) at Day 90. Subjects receiving this injection will re-commence~     Follow-up Visits and be followed for an additional 270 days.~   "
179097|NCT01220713|"~     The goal of this research is to serve as a demonstration project to determine the~     tolerability of individuals with persistent post-concussive symptoms from combat-related mild~     TBI (traumatic brain injury), identify dose-finding for HBO2 (Hyperbaric Oxygen) therapy, and~     determine the efficacy of HBO2 therapy.~   "
179098|NCT01220700|"~     The purpose of this study is to determine if suture material coated by antimicrobial agent~     triclosan would decrease the incidence of surgical site infections (SSIs) in paediatric~     surgery compared to ordinary sutures.~      1500 children (age form 4 weeks to 18 years) coming for general pediatric surgery to the Oulu~     University Hospital are randomised to have sutures coated with triclosan (Vicryl Plus,~     Monocryl Plus) or ordinary sutures. The occurrence of SSIs is monitored by email~     questionnaires to the parents on days 10 and 30. The diagnosis of SSIs are made along CDC~     criteria.~   "
179099|NCT01220687|"~     This study hopes to determine whether nitric oxide along with oxygen during the first 20~     minutes of life in infants needing help with breathing will reduce the percentage and total~     exposure to oxygen during that time frame. Although the use of oxygen in management of~     breathing is an important part of supporting baby immediately after delivery, there is more~     evidence that too much exposure to oxygen may lead to potential problems for your baby later.~     Oxygen exposure can be harmful to premature babies developing lungs.~   "
179100|NCT01220674|"~     The investigators are developing a computer-based neuropsychological assessment tool to help~     primary care physicians detect neurological and psychiatric disorders. To confirm the tool's~     efficacy, the investigators will first test the prototype against established tests. The~     investigators propose to collect preliminary data on a limited group of subjects and~     age-matched controls. Collecting data on a limited group of subjects provides early insight~     into how well the tool detects disease, how well patients understand the instructions and~     enjoy performing the tasks, and if particular trials or stimuli are too difficult or too easy~     for all subjects. With this information, the investigators can make adjustments to the tool~     if needed and collect additional data on revised versions of the tool. The data will be used~     to establish the validity, reliability and sensitivity of the tool to generate consistent and~     accurate scores. The investigators will initially focus on a limited age range (age~     fifty-five to seventy-five) and limited set of diseases (early dementias or mild cognitive~     impairment) to reduce variability within the patient and control groups and to gain more~     statistical power with a smaller group of subjects.~   "
179101|NCT01220661|"~     In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use~     of antibiotics for colorectal surgery is three doses.~      It has been reported that the surgical site infection rates of laparoscopic colorectal~     surgery are lower than open colorectal surgery. However, the evidence of proper application~     of antibiotic for laparoscopic colorectal surgery is still not enough.~      The investigators are researching the efficacy and safety of one dose prophylactic antibiotic~     in laparoscopic colorectal surgery.~   "
179102|NCT01220648|"~     This study will assess the maximum tolerated dose of low dose interferon in conjunction with~     nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia~     patients in chronic phase (CML-CP).~   "
179103|NCT01220635|"~     This study aims to evaluate the short-term and long-term efficacy of two preventative~     intervention approaches designed to support middle school youth.~   "
179104|NCT01220622|"~     The trial was designed to test the hypothesis that early treatment with nimodipine has a~     positive effect on cognition impairment after acute ischemic stroke.~   "
179105|NCT01220609|"~     This phase II trial is studying the side effects and how well ixabepilone works in treating~     patients with recurrent or persistent leiomyosarcoma of the uterus previously treated with~     chemotherapy. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~   "
179106|NCT01220596|"~     Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with~     Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B.~        -  Increased HBeAg seroconversion rate~        -  Increased HBsAg loss rate~        -  To define the best treatment condition for chronic HBV hepatitis patients~   "
179107|NCT01220583|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. It is not yet known whether~     radiation therapy is more effective when given together with chemotherapy or alone after~     surgery in treating salivary gland tumors.~      PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without~     chemotherapy to see how well it works in treating patients with high-risk malignant salivary~     gland tumors that have been removed by surgery.~   "
179108|NCT01220570|"~     This clinical trial will evaluate whether treatment with ridaforolimus, dalotuzumab, or~     ridforolimus/dalotuzumab combination therapy reduces Growth Factor Signature (GFS) Score~     among participants with breast cancer.~   "
179109|NCT01220557|"~     This study is a randomized prospective trial with 6-month follow up. A non-inferiority~     hypothesis is tested. A new developed treatment and education programme for type 1 diabetic~     patients (PRIMAS) will be tested compared to an established treatment and education programme~     (German DTTP). Primary outcome variable is glycemic control at 6-month follow up. Secondary~     outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms,~     diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin treatment,~     hypoglycemia awareness.~   "
179110|NCT01220544|"~     Experimental and clinical data suggest that alloreactive NK cells can reduce the risk of~     graft-rejection, GvHD and leukemic relapse after HLA-mismatched transplantation. The~     effectiveness of allogeneic NK cells is a function of HLA-differences between donor and~     recipient that give rise to NK cell clones which do not express inhibitory receptors matching~     for the HLA molecules of the recipient. Aim of the study is to evaluate cellular therapy with~     alloreactive, IL-2 activated NK cells after transplantation of T-cell depleted stem cell~     grafts from one haplotype mismatched family donors in patients with hematological~     malignancies.~   "
179133|NCT01220245|"~     In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be~     compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority~     principle for the patency. Besides equal patency, an improved quality of life is expected.~     Recruitment will take the first two years and patients will be followed during five years.~     Patients with an indication for surgical bypass, classified category 3-6 with a >50% stenosis~     or occlusion of the SFA over >/=10 cm in length will be included. At least one crural artery~     should be patent without significant lesions.~   "
179111|NCT01220531|"~     Complete DiGeorge anomaly (cDGA) is a disorder in which there is no thymus function. With no~     thymus function, bone marrow stem cells do not develop into T cells, which fight infection.~     Complete DiGeorge anomaly patients cannot fight infection and are immunodeficient. Without~     successful treatment, cDGA patients usually die by age 2 years.~      Thymus transplantation with and without immunosuppression (drugs given before and after~     transplantation) has resulted in the development good T cell function in complete DiGeorge~     anomaly subjects.~      This expanded access study continues thymus transplantation safety and efficacy research for~     the treatment of complete DiGeorge anomaly. Eligible participants undergo thymus~     transplantation and biopsy. Immune function testing is continued for one year~     post-transplantation.~   "
179112|NCT01220518|"~     This study is the trial to demonstrate how our product is similar to remicade by comparing~     the results of blood samples in active Ankylosing Spondylitis patients.~   "
179113|NCT01220505|"~     The purpose of this Post Market Surveillance Validation is to document the performance and~     clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity~     Correction System.~   "
179114|NCT01220492|"~     Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized by~     distortion of the hepatic architecture and formation of regenerative nodules. The liver~     transplantation is one of the only effective therapies available to such patients. However,~     lack of donors, surgical complications, rejection, and high cost are it`s serious problems.~     The potential for stem cells to differentiate into hepatocytes cells was recently confirmed.~     Particularly, autologous bone marrow-derived mesenchymal stem cell (BM-MSC) has been~     demonstrated to decrease MELD score and increase serum albumin in 4 of patients with~     decompensated liver cirrhosis. Therefore, the investigators propose a hypothesis that~     umbilical cord-derived MSCs (UC-MSC) can also improve the disease conditions of LC patients,~     particularly reducing the decompensated conditions in these patients.~   "
179115|NCT01220479|"~     Type 1 diabetes mellitus (T1DM) is associated with multiple co-morbidities, such as~     hypertension, dyslipidemia, coronary heart disease and osteoporosis. The foundation of these~     conditions lays in childhood. Exercise is known to have a positive influence on bone mineral~     density (BMD) and some impact on cardiovascular disease risk factors in healthy children, but~     little is known about these associations in children with T1DM.~      The main purpose of this study is to assess the effects of a 9-month weight-bearing exercise~     training program on skeletal development in children with T1DM, compared to healthy subjects.~     The second aim is to evaluate whether the program influences also cardiovascular diseases~     risk factors.~      This is a randomized controlled study incorporating 30 children with T1DM and 30 healthy~     children. Both groups are randomly divided (1:1) in an exercise or a control group: 1)~     exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy.~      Exercise groups participate to an identical weight-bearing exercise training program 2 x 90~     minutes per week and controls are relatively inactive.~      Main measures include: total body, lumbar spine and hip BMD by DXA, body fat and fat-free~     mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood lipids.~   "
179116|NCT01220466|"~     The results of this trial will demonstrate that the iDesign System performs as intended and~     is acceptable in a clinical setting.~   "
179117|NCT01220453|"~     The present trial is aimed to document efficacy (bowel cleanliness), acceptance and~     tolerability as well as patient comfort in the use of the new bowel cleansing product~     PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel~     cleanliness, acceptance, tolerability and patient comfort are affected by specific practice~     procedures, changes in dose etc.~   "
179118|NCT01220440|"~     The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on~     neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD~     within a double-blind cross-over design over six weeks. The assessment of ADHD followed~     formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A~     neuropsychological testbattery and four behavioral questionnaires were selected as efficacy~     variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory~     control, motor activity), Score (auditory attention), Stroop Test (processing speed,~     inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on~     each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed~     by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by~     the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed~     by a parent and a teacher Monday till Friday through every week), Test Performance~     Questionnaire (completed by the child immediately after each of the three test sessions).~      Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will~     provide better results than a trial including only Met. a)Met and Dex are efficient as~     treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to~     Met. b)At an individual level some of the participants will show positive response to one~     type of stimulants and no response, mixed response or adverse response to the other type of~     stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in~     agreement but also add unique information in the assessment of the effect of stimulants.~     d)Qb-test is sensitive and valid as a measure of the effect of stimulants.~   "
179119|NCT01220427|"~     The purpose of this study is to determine whether specific Micro-RNA expression profiles are~     related to Prostate cancer outcome.~   "
179120|NCT01220414|"~     The purpose of this study is to examine opioid and endocannabinoid mechanisms of~     exercise-induced analgesia in men and women.~   "
179121|NCT01220401|"~     The purpose of this study is to find out what effects Exposure, Rescripting, and Relaxation~     Therapy (ERRT) has on nightmares and associated problems in veterans.~   "
179122|NCT01220388|"~     Data from the literature and previous in vitro research conducted in the investigators'~     laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid~     secretion might be controlled by a paracrine mechanism involving serotonin type IV receptor~     (5-HT 4). L-lysine, a common amino-acid has been shown to act as a 5-HT4 agonist in vitro as~     well as in vivo. In the present physiology trial, plasma aldosterone and cortisol levels will~     be measured under treatment with aprepitant versus placebo, in both basal conditions and~     after activation of the adrenocortical function by various stimuli, including upright~     posture, metoclopramide, and after a 3 days salt-free diet. All healthy volunteers will be~     given two substances (L-lysine and placebo) in a random order during two 13 days periods~     separated by a 14 day-wash-out. This study should allow to determine the role of 5-HT4~     receptors in the control of corticosteroid production in normal man.~   "
179134|NCT01220232|"~     This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male~     and/or female subjects, to estimate the effect of steady state lersivirine on the steady~     state pharmacokinetics of abacavir/lamivudine.~   "
184101|NCT01155050|"~     This study will assess the effect of in-home tele-health monitoring on health outcomes for~     LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or~     hypertension.~   "
179123|NCT01220375|"~     High-dose chemotherapy with autologous stem cell support is the current standard procedure in~     the first-line treatment in younger patients with myeloma fit for intensive treatment.~     Current practice in Switzerland for stem cell mobilization is the combination of chemotherapy~     and G-CSF stimulation in myeloma patients fit for high-dose chemotherapy with melphalan and~     autologous stem cell transplant. In this trial the intravenous application of Plerixafor is~     being investigated in respect of the capability of the mobilization of stem cells from the~     bone marrow into the peripheral blood. In contrast to the twice daily application of G-CSF~     (eg. Neupogen) for several days, Plerixafor has to be injected just one-time.~   "
179124|NCT01220362|"~     Postoperative urinary retention (POUR) is one of the most common complications after surgery~     and neuraxial anesthesia of which the treatment of choice is bladder catheterization 1. It~     has been a common practice to place an indwelling catheter in the bladder in patients~     receiving epidural analgesia and to leave the catheter as long as the epidural analgesia is~     maintained despite a lack of evidence supporting this approach.~      Transurethral catheterization is associated with significant morbidity such as patient~     discomfort, urethral trauma and urinary tract infections (UTI). Prolonged catheterization is~     the primary risk factor for catheter associated UTI (CAUTI), which is one of the most common~     nosocomial infections and can prolong hospitalisation 2. For this reason there is a growing~     focus on limiting the duration of catheterization and finding methods to avoid unnecessary~     catheterization in perioperative medicine 3,4.~      Lower urinary tract function depends on coordinated actions between the detrusor muscle and~     the external urethral sphincter. Motorneurons of both muscles are located in the sacral~     spinal cord between L1 and S4. Most afferent fibers from the bladder enter the sacral cord~     through the pelvic nerve at segments L4-S2.~      Because epidural analgesia can be performed at various levels of the spinal cord, it is~     possible to block only a portion of the spinal cord (segmental blockade). Based on the~     innervation of the bladder and sphincter between L1 and S4 it can be assumed that epidural~     analgesia within segments T4-6 to T10-12 has no or minimal influence on lower urinary tract~     function.~      In a previous study, we found, against our expectations that thoracic epidural analgesia~     (TEA) significantly inhibits the detrusor muscle during voiding, resulting in clinically~     relevant post-void residuals which required monitoring or catheterisation 5. Because the~     study adopted a before-after design, we could not definitively identify the mechanisms~     responsible for this change in bladder function. In particular, we could not determine~     whether TEA per se or surgery was the main cause. Concerning TEA, it remains unclear which~     compounds of the solution, the local anesthetic, the opioid or both are responsible for the~     observed changes in lower urinary tract function.~      The aim of this study is to compare lower urinary tract function before and during TEA with~     two different epidural solutions (group 1: bupivacaine 1.25 mg/ml vs group 2: bupivacaine~     1.25 mg/ml combined with fentanyl 2 µg/ml) within segments T4-6 to T10-12 for postoperative~     pain treatment in patients undergoing lumbotomy for open renal surgery.~      We expect that a better understanding of lower urinary tract function during TEA could lead~     to a more restrictive use of indwelling transurethral catheters perioperatively.~   "
179125|NCT01220349|"~     Despite careful monitoring of patients with diabetes, it is so far difficult to predict the~     occurrence of cardiac events in the evolution. As shown by various studies conducted in~     patients with diabetes, cardiac involvement can be detected by abnormalities of diastolic or~     systolic functions using non-invasive investigations such as echocardiography. For 4 years,~     the evaluation technique of myocardial deformations by two-dimensional speckle tracking~     strain by echocardiography is the subject of high hopes in the earlier detection of still~     asymptomatic cardiomyopathies. In the present study, the investigators hypothesized that this~     technique would improve the detection of myocardial contraction abnormalities in patients~     with insulin-dependent diabetes mellitus (IDDM), and would establish their association with~     micro-angiopathy, frequently encountered in these patients.~   "
179126|NCT01220336|"~     Randomized control trial studying the effect of medical assistant health coaching for~     patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary care~     community clinics, Mission Neighborhood Health Center and Southeast Health Center~   "
179127|NCT01220323|"~     In the present study, the investigators intend to investigate whether anodal transcranial~     direct current stimulation (tDCS) may be effective in reducing pain in chronic pain patients.~   "
179128|NCT01220310|"~     Doctors and web-based self-management support pilot study will test whether health~     professionals' observation of an online patient workshop on self-management of diabetes and~     participation in structured learning sessions on self-management strategies will change the~     attitudes and confidence of physicians and other health professionals regarding their~     willingness and ability to perform self-management interventions with patients. If this pilot~     suggests that attitudes and confidence levels can change, we hope to launch a larger study to~     examine this method of learning and its effectiveness in more detail.~   "
179129|NCT01220297|"~     A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease~     (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell~     transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high~     risk non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL)~   "
179130|NCT01220284|"~     Vinorelbine (NVB) and platinum compounds are anticancer agents with broad spectrum of~     efficacy, clinically and preclinically proven synergism and only partially overlapping~     toxicities. Combinations with vinorelbine and platinum compounds with limited neurotoxicity~     are among the most used palliative regimens in a variety of solid tumors, including NSCLC,~     breast and cervical cancer. The oral platinum analogue satraplatin (SATRA) has been brought~     into clinical development because of the antitumor activity and toxicity comparable to those~     of carboplatin, together with a good acceptability of the oral administration.The recent~     availability of oral formulation of anticancer agents of proven efficacy in some indications~     is likely to become a valid option which could affect clinical daily management. The oral~     administration of vinorelbine and satraplatin might represent a reasonable option of~     palliative treatment in patients with advanced breast cancer, NSCL, GU or GY tumors for which~     a curative treatment can not be provided.~   "
179131|NCT01220271|"~     The purpose of this trial is to show proof of concept that by blocking the Transforming~     Growth Factor-beta signaling pathway in patients with Glioblastoma, there will be clinical~     benefit.~      Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with~     radiochemotherapy with temozolomide for Phase 2 in patients with glioma eligible to receive~     radiochemotherapy with temozolomide (e.g. newly diagnosed malignant glioma World Health~     Organization Grade III and IV).~      Phase 2a: To confirm the tolerability and evaluate the pharmacodynamic effect of LY2157299 in~     combination with standard radiochemotherapy in patients with newly diagnosed glioblastoma.~   "
179132|NCT01220258|"~     One objective of this study is to determine the levels of markers of inflammation on the~     eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy~     volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the~     effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and~     conjunctivae and on signs and symptoms of blepharoconjunctivitis.~   "
179135|NCT01220219|"~     The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate~     release capsule and 3) evaluate the safety and tolerability of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule.~   "
179136|NCT01220206|"~     POMx can be used as a treatment for erectile dysfunction.~   "
179137|NCT01220193|"~     The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular~     conditions to include normal, pathology, post refractive surgery and cataract.~   "
179138|NCT01220180|"~     This study collects post-marketing safety and efficacy surveillance data in real world~     clinical use of pregabalin for its approved indications in Korea.~   "
179139|NCT01220167|"~     The purpose of this study is to compare dosing effect of water on the single dose~     bioavailability of Ondansetron ODFS 8mg (MonoSol Rx, USA) administered with and without water~     to Zofran ODT® 8mg administered without water in healthy male and female adult, human study~     participants under fasting conditions.~        -  To monitor clinical status, adverse events and laboratory investigations, and to assess~          the relative safety and tolerance of the study drug formulations under fasting~          conditions.~        -  To estimate intra-subject coefficients of variation (CV).~   "
179140|NCT01220154|"~     Phase I study to evaluate intraperitoneal carboplatin along with weekly intravenous~     paclitaxel and bevacizumab in order to establish a tolerable dose and define the toxicity of~     this regimen in previously untreated patients with advanced ovarian carcinoma.~   "
179141|NCT01220141|"~     This study is conducted in Europe and Asia. The aim of this observational study is to monitor~     antibody formation towards the room temperature stable formulation of NovoSeven® (activated~     recombinant human factor VII).~   "
179142|NCT01220128|"~     The purpose of this study is to evaluate the safety, immunogenicity and clinical activity of~     a new WT1 anti-cancer immunotherapy in patients with WT1-positive Stage II or III breast~     cancer. The treatment will be given before surgery in combination with standard therapy.~   "
179143|NCT01220115|"~     A long term observational study in sickle cell disease will enhance the understanding of the~     disease patterns, current transfusion practices, treatments and outcomes in sickle cell~     disease.~   "
179144|NCT01220102|"~     The purpose of this observational study is to assess the efficacy of Epiduo and patient~     adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years)~     with moderate inflammatory acne using this drug first time in topical monotherapy.~   "
179145|NCT01220089|"~     The study has two primary aims. The first aim is to assess the efficacy of adding in-person~     visits to the use of portion-controlled foods for long-term weight loss. The second aim is to~     assess the use of trained lay counselors for the maintenance of weight loss. The primary~     endpoint of the study will be changes in weight. Secondary endpoints will include changes in~     body mass index (BMI), cardiovascular risk factors, health-related quality of life, and~     cost-effectiveness. The addition of in-person visits with the weight loss counselor is~     predicted to lead to greater long-term weight loss than the use of portion-controlled foods~     alone.~   "
179146|NCT01220076|"~     The biological response to treatment with tamoxifen in the preoperative situation is studying~     in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +.~      The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of~     TAM will be studied.~   "
179147|NCT01220063|"~     The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4~     fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation~     session).~   "
179148|NCT01220050|"~     The risk of fracture for kidney transplant recipients is 4 times higher that of the general~     population. The hyperparathyroidism plays a key role in the maintenance or development of~     post-transplant alterations of bone remodelling.~      Renal transplant patients are at high risk of hyperparathyroidism, largely because of~     long-lasting renal insufficiency before transplant, and of progressive deterioration of~     kidney function because of chronic allograft nephropathy (a disease of proteinuria and~     progressive decline of the glomerular filtration rate).In hemodialysis patients, intravenous~     paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster~     and more effective normalization of parathyroid hormone (PTH) levels than calcitriol~     (1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum~     calcium and phosphorus levels.~      Whether oral paricalcitol may help achieving a prompt reduction in serum PTH levels and,~     secondarily, in urinary protein excretion in renal transplant recipients with secondary~     hyperparathyroidism is worth investigating.~   "
179149|NCT01220037|"~     In the present study, the effects of age and dietary intake will be assessed on myocellular~     characteristics during 72 hours after a resistance type exercise session.~   "
179150|NCT01220024|"~     This study will assess pain intensity for the first 72 hrs after after aggravated movement~     (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the~     CollaRx Bupivacaine implant or a plain collagen sponge.~   "
179151|NCT01220011|"~     The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser~     surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an~     international randomized controlled trial. This trial will answer an important question and~     will help in the management and tailoring of surgical indications in stage 1 TTTS.~   "
179152|NCT01219998|"~     Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following~     paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase~     of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several studies~     included heterogeneous populations of children undergoing cardiac surgery, but NGAL has not~     been studied in neonates after open heart surgery, neither has been identified the threshold~     for accurate prediction of severe AKI requiring renal replacement therapy.~      The aim of this observational cohort study is to describe postoperative kinetics of urinary~     NGAL in neonates and to identify the threshold for accurate prediction of severe AKI~     requiring renal replacement therapy in neonates and infants undergoing cardiac surgery~   "
179153|NCT01219985|"~     Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer~     imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism.~     In case of cancer, metabolism is, classically, increased and some hot spots are visible on~     PET images. Because of respiratory motion and because the liver is intrinsically FDG avid,~     some tumours (especially the smallest ones) can be occulted and missed by the clinician.~      The investigators developed a respiratory-gated PET method in order to reduce the motion~     issue. This protocol has been validated on lung pathologies. The investigators designed a~     study to investigate its effect on liver cancer (primary or metastasis) to check if it allows~     the detection of a higher number of tumour lesions.~      To that aim, patients who are planned to undergo a surgical intervention on the liver can be~     proposed to participate this study. After the standard PET acquisition (acquired in~     free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed~     without additional injection. After that, a breath-hold (~10s) CT is performed.~   "
179154|NCT01219972|"~     This is a prognostic study of the late lung complications arising at the patient's having~     received an allograft of hematopoetic stem cells.~   "
179155|NCT01219959|"~     Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal,~     Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous~     Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as~     measured by the magnitude of change from the baseline value in the HbA1c levels.~      Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis~     solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to~     lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic~     events requiring medical intervention, improved metabolic control, nutritional status, and~     Quality of Life.~   "
179156|NCT01219946|"~     Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in~     lung function and increased symptoms such as breathlessness/dyspnoea, cough and~     expectoration.~      Even though subjective in nature, the symptomatology of COPD and mainly that of~     breathlessness/dyspnoea has been studied with the use of objective measurement tools. Taking~     into consideration that the symptoms experienced by the patient who suffers from a~     progressive disease such as COPD can only be perceived and interpreted by the patient him- or~     herself, and thus difficult to be quantified, COPD remains a challenge in clinical research.~      Therefore, there is a need to carry out qualitative studies that will provide insight into~     the wide spectrum of COPD symptomatology from the patient's perspective. In addition, a~     further mapping of the impact that COPD symptoms' perception has on a patient's life is~     required, as well as of the different pathways through which symptoms' perception is~     interpreted regarding the limitations of daily living activities, and the subsequent impact~     on disease management. The more the physician learns on the embodied experience of COPD, the~     better he/she may assist the patient in achieving optimal COPD management.~      Thus this cross-sectional observational study was designed aiming to obtain these data.~     Specifically, the study aims to evaluate the most frequently used words by the patients and~     the physicians to express the symptoms of COPD as well as the limitation of activities that~     it causes.~   "
179157|NCT01219933|"~     This open-label, single-arm study will assess the use of glucocorticoids (GC) in daily~     clinical practice and will evaluate the dose reduction of glucocorticoids once low disease~     activity is achieved in patients with rheumatoid arthritis tre ated with GC and background~     RoActemra/Actemra (tocilizumab) 8mg/kg intravenously every 4 weeks. In the non-interventional~     phase, the use of GC in daily clinical Belgian practice will be evaluated and described. This~     period of maximum 6 mont hs will allow those patients to obtain the inclusion criteria for~     the secondary interventional phase. In the interventional phase, a systematic GC dose~     reductio n schedule will be evaluated in patients having achieved low disease activity wh ile~     receiving the same background therapy with RoActemra/Actemra 8 mg/kg. Methyl prednisolone~     will be given from a starting dose of >/= 1 mg to </=20 mg orally d aily and will be tapered~     down. The anticipated study duration is up to 13 months~   "
179158|NCT01219920|"~     The purpose of the study is to evaluate if the exposure to all the three active cytotoxic~     agents (FOLFOXIRI regimen) is superior in terms of response rate to conventional chemotherapy~     with the FOLFIRI regimen as first-line treatment of metastatic colorectal cancer patients.~   "
179159|NCT01219907|"~     RATIONALE : Laboratory-treated T cells may stimulate the immune system in different ways and~     stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Vaccines made from HER2 peptides may help the body build an effective~     immune response to kill tumor cells that express HER2. Giving laboratory-treated T cells and~     cyclophosphamide after vaccine therapy may be an effective treatment for breast cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of ex vivo-expanded~     HER2-specific T cells when given together with cyclophosphamide after vaccine therapy in~     treating patients with HER2-positive stage IV breast cancer.~   "
179170|NCT01219764|"~     The proposed study will test the hypothesis that H. pylori can be eradicated successfully~     (>85%) using half-or full-dose concomitant non-bismuth quadruple therapy regimen:~     rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients~     with peptic ulcers and H. pylori related gastritis.~      Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be~     enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests,~     documenting H.pylori infection, will be randomized into one of two groups: Full dose or half~     dose the concomitant regimen, with 100 patients in each group. Compliance and side effects~     will be assessed, and a urea breath test will be done for all patients after 4 weeks of~     therapy completion to evaluate eradication rates. Success of therapy will be evaluated~     according to intent-to treat and per-protocol analyses.~   "
179171|NCT01219751|"~     To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma~     with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma~   "
179215|NCT01219166|"~     Gallbladder management in bariatric surgery is controversially discussed. While some surgeons~     advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB)~     others advocate CCE only in patients with pathological gallbladder findings. The aim of this~     study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic~     RYGB.~   "
179160|NCT01219894|"~     Patients who receive drug-coated stents (as opposed to the less frequently used bare metal~     stents) are currently recommended aspirin plus a thienopyridine such as Plavix, Effient, or~     Ticlid for one year. These guidelines apply to all patients with drug-coated stents,~     regardless of the type of stent they received. The purpose of these medications is to prevent~     a clot at the stent site when there is poor healing of artery tissues over the stent. A clot~     is a serious concern because it can suddenly block blood flow to the heart and cause a heart~     attack. These medications have been proven to be helpful in stent patients, but they do have~     risks. The common side-effects are related to bleeding which in a few patients can be~     serious. A patient may be at risk for forming a clot if they must put these medications on~     hold for a surgical procedure to reduce the risk of bleeding. Plavix and Effient are also~     expensive for patients who are underinsured or uninsured. There is interest is finding a way~     to show that a patient's stent has healed properly before 12 months and that they can safely~     stop these medications early.~      This study is looking at a way to determine if patients who receive the Endeavor drug-coated~     stent and who are prescribed aspirin and Plavix can safely stop Plavix at 3 months instead of~     12. Previous studies have shown 99.9% coverage of the body's own tissues on an Endeavor stent~     after 3 months.~      A device called an Optical Coherence Tomography (OCT) catheter will be used in this study to~     look at how much a stent has healed. It allows imaging inside a heart artery and the ability~     to see the healing of tissues over the stent.~   "
179161|NCT01219881|"~     This is a single-center, prospective, randomized, double-blind, double-arm trial including 68~     subjects scheduled to undergo urological cystoscope surgeries under general anesthesia (GA)~     with intubation through a laryngeal mask airway (LMA) at The Ohio State University Medical~     Center (OSUMC). Double blinding will be based on both the subject and the research staff~     being unaware of which trial arm the subject is randomized into. Eligible subjects that~     provide voluntary and written informed consent will be included in this study.~   "
179162|NCT01219868|"~     The objective of this study is to explore the impact of a physician-nurse team supervising~     patient's flow on ED length of stay~   "
179163|NCT01219855|"~     This study will investigate how the levels of a repeat dose of CTAP101 changes in the body~     over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances~     (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency~     and secondary hyperparathyroidism (SHPT).~   "
179164|NCT01219842|"~     Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent~     claudication (CI) affecting> 10% of individuals> 65 years. A recent Swedish Health Technology~     Assessment Report identified only limited evidence for the effectiveness of invasive~     treatment for IC in patients already on exercise training. The prognosis for the extremity is~     usually benign and treatment therefore aims at improving quality of life. Invasive treatment~     can also cause serious complications. Coronary artery disease is common in IC patients~     increasing the risk with invasive treatment. In spite of these uncertain merits and potential~     risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD~     in Sweden are performed for IC. The aim of this study is to evaluate the additional effects~     of modern invasive treatment in patients with intermittent claudication receiving modern best~     medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in~     addition to BMT improves health related quality of life and walking performance compared to~     BMT only.~   "
179165|NCT01219829|"~     The research purpose of this project is to create a registry, and blood and tissue bank for~     individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and~     molecular analysis of resected pancreatic tissue prospectively collected from a cohort of~     pancreatic cancer patients.~   "
179166|NCT01219816|"~     Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal~     prognosis. In this case, allogeneic transplantation is the only curative treatment when~     patient have obtained a second complete remission (CR. In France, in patients younger than 60~     years old,the HyperCVAD regimen used by the MDAnderson in Houston is generally applied. In~     older patients (>=60 years)or young patients <= 60 years no eligible for intense~     chemotherapy, a combination of vincristine + Dexamethasone is generally chosen in order to~     avoid too much toxicity but the result is worse in term of CR.~      More than 90% of ALL with a B phenotype (2/3 of cases in adults)express the surface antigen~     CD22 on leukemic blasts which thus represents an interesting target for therapy. Epratuzumab~     is a humanized anti-CD22 antibody produced by Immunomedics, Inc, Morris Plain (New Jersey,~     USA). Epratuzumab has already shown efficacy in lymphoma patients. Only one study, including~     15 children, has been published so far reporting the efficacy and the toxicity of Epratuzumab~     in the setting of ALL in monotherapy, one can observe 8 stable disease, 3 progressions and 4~     partial responses. When combining chemotherapy and Epratuzumab, 9CR were observed with~     acceptable toxicity. Tolerance was acceptable.~      The French GRAALL group proposes to test an age-adapted combination of chemotherapy +~     Epratuzumab, in refractory/relapses CD22+ B ALL patients in order to improve their prognosis,~     in term of CR, survival and of number of patients eligible for allograft.~   "
179167|NCT01219803|"~     Ge Gen Qin Lian Decoction are one kind of Chinese prescription, and previous study showed~     they had antidiabetic effects on the clinical patients and no obvious toxicity was found. The~     purpose of this study was to evaluate the efficacy and safety of different dosage of Ge Gen~     Qin Lian Decoction in the treatment of type 2 diabetic patients and explore relationship of~     the dosage and effect and the safety of 3 dosages of Ge Gen Qin Lian Decoction.~   "
179168|NCT01219790|"~     This study will determine the delayed neurotoxicity (12 months) of a hypofractionated high~     dose irradiation (3 Gy x 9) associated with zoledronic acid.~      The administration of zoledronic acid repeat dosages defined under the Authorisation on the~     Market.~      All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at~     least 48 hours apart each, for a treatment to J1, J3 and J5.~   "
179169|NCT01219777|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous~     weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with~     epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive~     neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo~     surgery which will allow an objective measure of response to the above regimen as well as~     assessment of surgical outcomes.~   "
179172|NCT01219738|"~     Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma~     membrane-mediated and do not require gene transcription and translation. One of these~     non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular~     smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic~     receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g.~     locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists~     (e.g. inhaled beta-adrenergic agonists).~   "
179173|NCT01219725|"~     The purpose of this study was to examine the effect of 6 months moderate intensity exercise~     training completed three times per week upon traditional and emerging cardiovascular disease~     risk factors in postmenopausal women both with and without type 2 diabetes. These risk~     factors include blood markers associated with increased risk such as cholesterol, insulin,~     glucose and markers of inflammation plus measures of body fat, heart and lung fitness,~     vascular stiffness and vascular function. The study hypothesised that moderate intensity~     exercise training would intervene in the exaggerated risk seen in women following the~     menopause, especially in those with type 2 diabetes.~   "
179174|NCT01219712|"~     Elderly patients undergoing surgery for proximal hip fracture have a high risk of morbidity~     and mortality (M&M) postoperatively. Several studies including some from the investigators~     department have shown that there is a high risk of cardiovascular complications in this group~     of patients and 3-month mortality is 15-20%. One of the causes of this high M&M is the high~     incidence of cardiac failure associated with an increased NT-proBNP in this group of~     patients. The aim of the present study is to evaluate whether optimization of preoperative~     cardiac function can reduce cardiac M&M postoperatively. Following verbal consent, patients~     with an increased NT-proBNP would be randomized to goal-directed preoperative optimization or~     standard management according to current hospital routines. Following optimization, the~     patients would be transferred to the operating rooms and subsequent management including~     perioperative patient management would be left to the discretion of a specialist~     anesthesiologist who is directly involved in patient care. Postoperatively, Troponin T and~     NT-proBNP would be measured in all patients according to the study protocol. In addition,~     major adverse cardiac events would be documented and follow-up would be done by after 30 days~     and 3 months postoperatively.~   "
179175|NCT01219699|"~     This is a first-in-man trial, in which BYL719 will be administered to adult patients with~     advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease~     has progressed despite standard therapy or for whom no standard therapy exists. A combination~     of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally~     advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The~     single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion~     cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type~     PIK3CA gene~   "
179176|NCT01219686|"~     The main purpose of this study is to determine whether the antidepressant response of~     escitalopram 30mg/day or escitalopram 20mg/day + pindolol, a beta blocker, is different~     (faster) compared to a standard dose of escitalopram 20mg/day.~   "
179177|NCT01219673|"~     The goal of this clinical research study is to compare armodafinil, bupropion, and~     minocycline when given alone or in combination. Researchers want to learn about the safety~     and level of effectiveness of these drugs in controlling symptoms, such as the side effects~     of chemoradiation, when given to patients with head and neck cancer.~   "
179178|NCT01219660|"~     To determine if autotitrating positive airway pressure (APAP) naïve patients with OSA can~     successfully use APAP following general anesthesia.~   "
179179|NCT01219647|"~     Many persons with Multiple Sclerosis ( MS) have problems with memory and thinking.Exercise~     has been shown to improve memory and thinking in persons with diseases such as Alzheimer's.~     This study will investigate whether a program of aerobic exercise can improve memory and~     thinking in persons with MS~   "
179180|NCT01219621|"~     1 Purpose~      In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal~     high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated~     bradycardia, single chamber atrial pacemakers are contraindicated although ventricular~     support is only rarely needed. As a result, these patients are usually exposed to an~     unnecessary high proportion of ventricular pacing due to the programming of the system to DDD~     mode for preventive safety reasons. This drains the pulse generator battery, and more~     importantly has long-term adverse effects on ventricular function in a subset of vulnerable~     patients, leading to left ventricular (LV) asynchrony, mitral regurgitation and increased~     left atrium (LA) size. The deleterious effects of right ventricular (RV) pacing, which~     increased heart failure (HF) morbidity/mortality, atrial fibrillation (AF) and related~     adverse events have been highlighted in several large clinical studies. Limiting RV pacing in~     non-dependant patients is therefore desirable.~      The Symphony DR 2550 cardiac pacemakers (SORIN Group, Montrouge, France) offer a new pacing~     mode that automatically switches from AAI(R) mode to DDD(R) or DDI(R) in event of severe~     atrioventricular conduction disorder, returning spontaneously to AAI(R) mode as soon as the~     spontaneous AV conduction has resumed. This particular mode is called the AAIsafeR2(R).~      The objective of this study is three-fold: to demonstrate that AAIsafeR2 mode (i) reduces the~     percentage of ventricular pacing in patients with a spontaneous AV conduction and (ii)~     prevents atrial arrhythmias by improving atrial hemodynamics and (iii) improves the long-term~     hemodynamic status of implanted patients in comparison to the standard DDD mode, set with~     long AV Delays (DDD Long AVD).~      The scientific soundness lying in this study is a proposal of an optimal programming of~     dual-chamber pacemakers (PM) with regard to the preservation of spontaneous AV conduction.~   "
179181|NCT01219608|"~     This is a double-blinded placebo-controlled block randomized study in intensive care patients~     comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of~     clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS)~     and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum~     inflammatory mediators will be compared.~   "
179182|NCT01219595|"~     The purpose of the research is to determine if eating sweetened, dried cranberries or~     strawberry fruit pieces will increase the types of different E. coli bacteria in the~     intestines which may reduce the likelihood of a major, or highly harmful urinary type of~     bacteria which cause urinary tract infections in susceptible women.~   "
179200|NCT01219361|"~     Couples who have created excess embryos while undergoing IVF procedures, and who do not wish~     to transfer those embryos or donate them to another couple may donate the extra embryos to~     research. The embryos are then used to develop improved laboratory techniques and conditions~     as well as testing the proficiency of laboratory staff.~   "
179377|NCT01217060|"~     The goal of this clinical research study is to learn if giving chemotherapy and radiation~     therapy before surgery for early-stage esophageal cancer can help to control the disease and~     if so, for how long. The safety of this treatment will also be studied.~   "
179183|NCT01219582|"~     An observational and multicenter study to assess the effectiveness and safety of Glucobay®- M~     under daily life treatment of type-2 diabetes patients.The study objectives are to~     investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body -~     weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus,~     where investigator feels that addition of Glucobay®-M would be beneficial to patients will be~     included in non- interventional study. The routine investigation suggested by the attending~     physician will be done in diabetic patients. No additional investigation will be done for the~     study purpose. The uncontrolled diabetic patient on existing treatment and prescribed~     Glucobay®-M will be included in study after taking the informed consent. The patient will be~     asked to attend 2 follow up visit each after 6 weeks. All patients receiving at least one~     tablet will be included in the safety analysis.The study is planned to be carried out in~     10000 patients from 320-350 trial sites in India.~   "
179184|NCT01219569|"~     This is a study to focus on the feasibility of using a monitor which may signal loss of~     visual function intraoperatively.~   "
179185|NCT01219556|"~     This is post-marketing observational study in which data on safety and effectiveness of~     Xirtam H will be collected from routine clinical practice. The study objectives are to~     investigate the effect of Xirtam-H on blood pressure and achievement of target blood pressure~     as well as safety and satisfaction of treatment. All hypertensive patients (Blood pressure >~     140/90 mmHg) where investigator feels that addition of Xirtam H would be beneficial to~     patients will be included in non interventional study. The routine investigation suggested by~     the attending physician will be done in patients of hypertension. No additional investigation~     will be done for the study purpose. The patient not controlled on existing treatment and~     prescribed Xirtam H will be included in study after taking the informed consent. The patient~     will be followed up for 2-follow up visit each after 6 weeks. The physical examination,~     routine investigation, blood pressure measures will be done and the data will be entered in~     the CRF as mentioned in CRF in each visit. The study is planned to be carried out in 9604~     patients from around 300 - 350 trial sites in India.~   "
179186|NCT01219543|"~     This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability~     of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in~     patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and~     non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate~     daily and BID dosing.~   "
179187|NCT01219530|"~     To explore the attitudes and reactions of gestational carriers and intended parents though~     their medical, pregnancy and postpartum experiences.~   "
179188|NCT01219517|"~     The purpose of this study is to validate the ability to assess the genetic differences (DNA~     fingerprinting) on polar bodies (excess genetic material given off from the egg) and cells so~     that this technique may be used in the future to confirm markers of reproductive competence~     and improve the efficiency and safety of clinical human in vitro fertilization.~   "
179189|NCT01219504|"~     To assess the impact of embryo biopsy on the reproductive potential of human embryos.~   "
179190|NCT01219491|"~     To identify the characteristics in an egg donor that are important to a recipient and to see~     if those characteristics change over time.~   "
179191|NCT01219478|"~     Purpose: To investigate the relationship between retinal thickness (RT) and metabolic risks~     (MRs) in patients without retinal lesion.~      Methods: Fifty-two patients over 60 y/o were divided into four groups according to their MRs~     of hypertension, hyperlipidemia or hyperglyceremia. After complete ophthalmic examination,~     optical coherence tomography was performed to measure RT.~   "
179192|NCT01219465|"~     The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of~     treatment for initial type 1 diabetes is safe and effective.~   "
179193|NCT01219452|"~     The main aim of the study is to determine whether intramuscular injection of umbilical cord~     mesenchymal stem cells can improve the ventricular function of children with idiopathic~     dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible~     mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate~     the safety of intramuscular injection of umbilical cord mesenchymal stem cell.~   "
179194|NCT01219439|"~     The researchers propose to investigate the causes, incidence, and time-related events of~     chromosomal and physiologic abnormalities as they relate to patient diagnosis, fertility~     drugs utilized, and in vitro laboratory culture conditions.~   "
179195|NCT01219426|"~     This study is divided into two stages. In the first stage, students from the University of~     Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling~     Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference~     tool for gambling problem severity (SOGS : South Oaks Gambling Screen). In the second stage,~     consecutive pathological gamblers seeking treatment at the University Hospital of Nantes~     completed the three questionnaires. Only questionnaires from participants who reported~     gambling at least one time in the past year were kept for analyses.Responses of students~     gamblers and pathological gamblers presenting for treatment have been compiled for~     analysis.The main objective of the study is to validate the French adaptations of the GABS~     and the GRCS, and to explore their psychometric properties and structures.~   "
179196|NCT01219413|"~     To evaluate the proteinuria lowering efficacy as well as tolerability and safety of the renin~     inhibitor aliskiren compared with that of placebo and angiotensin converting enzyme inhibitor~     perindopril in patients with non-diabetic chronic renal disease.~   "
179197|NCT01219400|"~     The purpose of this study is to explore whether the novel therapy of type 2 diabetes,~     vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon~     counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes.~     Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter~     hypoglycemia is induced under standardized conditions, and the glucagon response is~     determined, and compared to that after a month of placebo treatment.~   "
179198|NCT01219387|"~     The present study is designed to evaluate the basal serum levels of anti-mullerian hormone~     (AMH) and inhibin B as early predictors of ovarian response, implantation rate, and pregnancy~     rate in women 38 years old or older that are undergoing an IVF cycle.~   "
179199|NCT01219374|"~     To explore the attitudes and reactions of ovum donors prospectively after ovum donation and~     to follow their medical histories.~   "
179201|NCT01219348|"~     Title: IDO peptid vaccination in combination with immune stimulating agent Aldara and the~     adjuvant Montanide, for treatment of patients with locally advanced or metastatic non~     small-cell lung cancer. A first-in-man phase I trial.~      Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting~     the immune inhibiting enzyme, IDO to investigate the potential of vaccination against IDO as~     a possible anticancer target.~   "
179202|NCT01219335|"~     Use of discarded embryos to advance laboratory expertise and technology in the area of human~     embryo development and assisted reproductive technologies~   "
179203|NCT01219322|"~     Extravasation is an unintentional injection or leakage of fluids in the perivascular or~     subcutaneous space. Extravasation can be associated with tissue injury with various level of~     severity and long term consequences. Currently the confirmation of intravenous location of~     the Intravenous (IV) catheter requires close observation of the insertion site with~     sufficient infiltration in the perivascular area to allow detection of swelling,~     discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited.~     IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is~     known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to evaluate~     the safety and efficacy of intravenous SB as a detector of intravenous placement of an IV~     line in anesthetized patients.~      Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous~     injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and~     microscopic effects were evaluated and a safe dilution was determined. In the second part of~     the study the investigators will evaluated the efficacy of IV diluted SB to detect the proper~     location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled. Patients all~     under general anesthesia with standard controlled ventilation via endotracheal tube. The~     correct placement of IV catheter will be confirmed by easy aspiration of blood from newly~     placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume equivalent of~     normal saline will be injected in random order. The data collection will include patient's~     demographics, the presence or absence of an increase in the expired end-tidal carbon dioxide,~     onset and peak changes of end-tidal carbon dioxide as well as the hemodynamic changes after~     each injection.~   "
179204|NCT01219309|"~     Objective: To assess whether supplementation with Omega 3/6 fatty acids (eye q®) was~     effective in the treatment of ADHD and its diagnostic subtypes and comorbid conditions, in~     children and adolescents.~      Method: Randomized placebo-controlled one-way crossover trial with 75 children and~     adolescents aged 8-18 years receiving Omega 3/6 or placebo for three months followed by 3~     months with Omega 3/6 for all. ADHD symptoms were measured with the investigator-rated ADHD~     Rating Scale-IV-Parent Version and the Clinical Global Impression (CGI) scale of symptom~     severity and impairment.~   "
179205|NCT01219296|"~     Data collection and comparison of relationships between patient demographics, stimulation~     protocols and outcomes, retrieval and transfer outcomes, number and quality of oocytes and~     embryos retrieved and transferred, pregnancy rates and pregnancy outcomes.~   "
179206|NCT01219283|"~     The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis~     (PGD) increases implantation and delivery rates in couples attempting to conceive through in~     vitro fertilization (IVF).~   "
179207|NCT01219270|"~     Osmolality of contrast media can be resulted in translocational hyponatremia after~     percutaneous coronary intervention.~   "
179208|NCT01219257|"~     Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis,~     arthritis as part of inflammatory bowel disease and reactive arthritis) have axial~     involvement (the spine) as well as peripheral inflammation in joints and entheses (where the~     tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA~     may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus it~     is necessary to have a sensitive method for assessing the response to treatment.~     Ultrasonography (US) is a validated and reliable method for assessing disease activity in~     joints and tendons, and may be used to follow the treatment response.~      The present study will include patients with SpA starting on anti-TNF alpha treatment (as~     first biologic medication or when switching to a new biologic treatment). The study is an~     extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of~     arthritic patients starting disease-modifying treatment). The patients will be examined by~     use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months.~      The objectives are to explore US as a method to assess peripheral inflammatory activity for~     evaluation of response to medication as well as to compare the US pathology with clinical and~     laboratory findings.~   "
179209|NCT01219244|"~     The study will investigate whether dietary modification could provide positive effects on~     brain functions in elderly people with mild cognitive impairment.~   "
179210|NCT01219231|"~     The researchers will investigate whether exercise could provide positive effects on general~     brain functions in elderly people with impaired glucose tolerance.~   "
179211|NCT01219218|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients~     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.~   "
179212|NCT01219205|"~     Although it is important in the clinical management to classify BRVO into subtypes based on~     the location of the occlusion (major or macular), few studies have provided such~     information[8,9]. The aim of this study was to evaluate the outcome of patients with macular~     edema due to Branch retinal vein occlusion who were treated with intravitreal bevacizumab~     injection and to determine the concentrations of cytokines in the aqueous humor according to~     the site of the occlusion.~   "
179213|NCT01219192|"~     The purpose of this study is to evaluate the safety and tolerability and determine the~     recommended dosing for the treatment in patients with advanced pancreatic cancer after~     fist-line Gemcitabine treatment failure.~   "
179214|NCT01219179|"~     The improved survival rate of extremely low birth weight(ELBW)infants has resulted in new~     fluid and electrolyte problems that have not been encountered previously,in particular~     electrolyte imbalance. ELBW infants are especially vulnerable to hypernatremia(serum sodium~     value >150 mEq/L). Hypernatremia may be due to rapid dehydration or excessive administration~     of intravenous fluids(IV)that contain sodium. The current treatment modality for~     hypernatremia is to increase IV fluids above daily requirements.Enteral sterile water~     feeds(ESWF)are theorized as an endogenous source of fluids that may decrease elevated~     electrolytes such as sodium and potassium in premature infants. By giving ESWF to decrease~     elevated electrolytes, there would be less need for large volumes of IVF that contribute to~     the co-morbidities of prematurity: bronchopulmonary dysplasia (BPD),intraventricular~     hemorrhage(IVH)and patent ductus arteriosus(PDA).~      The purpose of this proposed study is to determine whether enteral sterile water feedings is~     effective in decreasing the incidence, duration and severity of hypernatremia in ELBW~     infants.~   "
179216|NCT01219153|"~     The aim of this randomized controlled trial is to compare the efficacy of extended high dose~     letrozole regimen (5 mg /day for the first 5 days of cycle and 2.5 mg/day for the subsequent~     3 days ) with short low dose letrozole regimen (2,5 mg/day from cycle day 3 to 7 ) as an~     adjuvant to GnRH antagonist protocol in the management of patients with poor ovarian response~     undergoing IVF-ET.~   "
179217|NCT01219140|"~     Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate~     extract capsules will produce statistically significant changes in biomarkers for bone~     resorption and formation when compared to subjects receiving placebo.~   "
179218|NCT01219127|"~     Management of chronic diabetic foot skin ulcers require multidisciplinary approaches~     including diabetic control, wound care, antibiotic, shoe wear off-loading, and surgery in~     selected cases. The results are inconsistent and irregular, and most studies reported~     unsatisfactory results. Many adjunctive therapies are implemented in the care of chronic~     diabetic foot ulcers including hyperbaric oxygen therapy (HBO), ultrasound, recombinant human~     platelet-derived growth factor-BB (rPDGF-BB), vacuum assisted wound closure (VAWC) and~     acellular matrix. HBO is the most commonly utilized at the investigators institution. Mixed~     results of HBO in chronic diabetic foot ulcers are reported. Several studies reported that~     the beneficial effects of HBO, but none showed universal success. Therefore, the development~     of a new effective method of treatment for chronic diabetic ulcers is extremely valuable.~     Extracorporeal shockwave therapy (ESWT) acts as mechanotransduction that produces the~     therapeutic benefits through complex biological pathways including neovascularization and~     tissue regeneration. ESWT also showed bacteriostatic effects in experiments. Some studies~     reported the effectiveness of ESWT in acute and chronic soft tissue wounds. Others reported~     effectiveness of ESWT in chronic ulcers with 50% completely healed with 6 sessions of~     treatment. With this background, it appears that ESWT may be effective in the treatment of~     chronic diabetic foot ulcers. The purpose of this study is to evaluate the efficacy of ESWT~     in chronic foot ulcers, and to compared with that treated with HBO, and to study the~     molecular and blood flow perfusion before and after ESWT.~   "
179219|NCT01219114|"~     The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions~     of actual use in patients who are diagnosed with complicated Skin and Skin Structure~     infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are~     prescribed CUBICIN by their physician.~   "
179220|NCT01219101|"~     According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but only~     30-40% becomes pregnant. The difference has been attributed to a negative action of clomifen~     citrate(CC) in the form of prolonged antiestrogenic effects on endometrial receptivity. For~     avoiding of these negative effects, giving ethinyl estradiol in sufficient dosages may be~     effective. The purpose of this study is comparing pregnancy rates after IUI in women who use~     CC alone and those who use CC in combination with ethinyl estradiol~   "
179221|NCT01219088|"~     Falls are a common problem in elderly patients resulting fractured femur, which require early~     operation. Adequate postoperative pain control will provide good recovery. The investigators~     will compare the efficacy of postoperative pain control among intrathecal morphine, femoral~     nerve block, and periarticular infiltration with bupivacaine in patients undergone~     intramedullary hip screw under spinal anesthesia.~   "
179222|NCT01219075|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This~     clinical trial studies soy isoflavones supplementation in treating women at high risk for or~     with breast cancer.~   "
179223|NCT01219062|"~     Falls are a common problem in elderly people which they have to receive the operation.~     Hemiarthroplasty is one of the common orthopedics operations. The prompt operation and good~     pain control will provide the good recovery and outcome. The investigators compare the~     efficacy of postoperative pain control between Intrathecal morphine 0.1 milligrams (mg.) with~     the local infiltration of 0.25% Bupivacaine for 20 milliliters (ml.) in patients received hip~     hemiarthroplasty under spinal anesthesia.~   "
179224|NCT01219049|"~     Patients in the study, who have a diagnosis of fibromyalgia, will be randomly assigned to~     take the amino acid L-tyrosine or placebo (blank pill) for 3 weeks. They will fill out~     questionnaires about their symptoms and see if they have any improvement. The investigators~     hypothesis is that taking tyrosine will help alleviate the symptoms of fibromyalgia.~   "
179225|NCT01219036|"~     Asthma usually responds to standard doses of inhaled steroids with or without additional~     therapies to control their symptoms. However, approximately 5-10% do not respond to this~     treatment strategy and are referred to as having difficult asthma. Evidence shows that this~     poor response is not always related to asthma severity with non-adherence to treatment being~     a common underlying problem, in 35% of subjects. Recognising non-adherence in the clinic is~     problematic as there is no straightforward objective test to identify it.~      Patients attending an asthma clinic whose symptoms are not controlled by standard treatment~     will be assessed for airway inflammation using fractional exhaled nitric oxide, and sputum~     analysis. These subjects will be observed taking their medication to determine if this~     reduces their level of airway inflammation. Prescription records will be used to ascertain if~     this test distinguishes those who are non-adherent with their treatment from those adults who~     have severe asthma.~      Identifying patients who are non-adherent to treatment will allow an appropriate change in~     management and enable alternative strategies to be developed to tackle non-adherence in this~     population. Distinguishing patients who are adherent to treatment but have therapy resistant~     disease would significantly improve treatment effectiveness in this group by allowing these~     patients to be suitably targeted with expensive novel therapies such as Omalizumab.~   "
179246|NCT01218763|"~     This clinical investigation is a prospective, non-randomized, multi-center pivotal trial.~      This trial aims to validate the automatic detection features provided by the external~     long-duration SpiderFlash-t™ Event recorder coupled with its analyser EventScope™, and to~     assess the performances of the Mode Switch function provided by Sorin Group Implantable~     Cardioverter-Defibrillators (ICDs).~      This trial is being performed first in order to demonstrate the ventricular tachycardia (VT)/~     ventricular fibrillation (VF) sensitivity of the automatic VT/VF detection function of the~     EventScope™ software.~      Patients will be implanted with an ICD from Sorin Group, with PARAD+ arrhythmia detection~     enabled and Mode Switch (MS) algorithms activated in all patients.~      Arrhythmic events will be documented over a period of 6 to 8 weeks for each patient.~   "
179226|NCT01219023|"~     Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysethesia (PPE), occurs in a~     25%-50% of patients treated with several commonly used anti-cancer drugs including~     capecitabine and sunitinib. These drugs are known to improve survival in many cancers,~     including cancers of the colon, stomach, liver, breast, kidney, and GI stromal tumors (GIST).~     Worldwide, over 400,000 patients per year are treated with one of these agents. HFS involves~     skin changes, such as swelling, peeling, and blistering of the palms and soles, which is~     often painful and debilitating. As a result, HFS-related symptoms can frequently lead to dose~     reduction and/or discontinuation of otherwise effective anti-cancer treatment. There is no~     treatment for HFS other than dose reduction or stopping treatment. This proposal could~     quickly lead to treatments to prevent and/or treat HFS and help patients avoid debilitating~     side effects while continuing otherwise effective treatments for their cancer.~   "
179227|NCT01219010|"~     The purpose of this study is to determine if siltuximab has an effect on the heart function~     measured by ECG recordings and more specifically to determine if siltuximab has an effect on~     the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS),~     Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM). The study will also~     look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM.~   "
179228|NCT01218997|"~     This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of~     repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to~     adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual~     of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1~     ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of~     VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.~   "
179229|NCT01218984|"~     This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults~     to assess the presence, duration, and degree of opiate blockade as well as the safety and~     tolerability of Medisorb® naltrexone (VIVITROL®). Subjects were randomized in a 1:1:1 ratio~     to receive a single gluteal intramuscular (IM) injection of Medisorb naltrexone 75, 150, or~     300 mg.~   "
179230|NCT01218971|"~     This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base~     study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4~     weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study~     ALK21-003.~   "
179231|NCT01218958|"~     This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted~     in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical~     Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive~     intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg,~     placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg~     (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.~   "
179232|NCT01218945|"~     The repair of large osseous defects remains still unsolved. Aim of this study is to isolate~     and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore,~     our research idea is to pre-engineer large synthetic bone grafts and study the~     vascularization process in vivo.~   "
179233|NCT01218932|"~     This is a standard pharmacokinetic interaction study. Subjects will be randomized to be~     either group A or B. Group A. Subjects will have 3 hospitalizations to complete. Each~     hospitalization will be about 12-24 hours depends on each regimen. Subjects in A group who~     receive regimen 1 of primaquine (PQ) on the first admission (visit 2) will receive regimen 2~     of primaquine and chloroquine combination (PQ and CQ) on second admission (visit 3) after 1~     week wash out period and will finish with regimen 3 of Chloroquine (CQ) on the third~     admission (visit 4) after 8 weeks wash out period.~      Subjects in B group who receive regimen 1 of primaquine (PQ) will receive regimen 2 of~     chloroquine (CQ) on second admission (visit 3) after 1 week wash out period and regimen 3 of~     primaquine and chloroquine combination (PQ and CQ)on third admission(visit 4) with 8 week~     wash out period in between.~   "
179234|NCT01218919|"~     The objective of this study is to evaluate the effectiveness of a rechargeable Deep Brain~     Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced,~     levodopa-responsive Parkinson's disease that are not adequately controlled with medication.~      This is the first observational study for the use of the BRIO™ rechargeable constant current~     device, using a lead with an active electrode tip for deep brain stimulation in Parkinson~     subjects. The current study was designed to conform to normal medical practices, taking into~     consideration the current day economic constraints, while assessing the best set of~     circumstances for the successful sustained reduction of some of the symptoms of advanced,~     levodopa-responsive Parkinson's disease that are not adequately controlled with medication.~   "
179235|NCT01218906|"~     The purpose of this study is to detect acute febrile episodes and dengue infection in five~     Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure~     at investigational sites in anticipation of a Phase 3 efficacy trial of a vaccine to prevent~     dengue infection.~      The primary objectives are:~        -  To identify acute febrile episodes among the cohort in order to detect the presence of~          dengue infection.~        -  To develop operational infrastructure for potential Phase III dengue efficacy trial~          sites.~        -  To describe the dengue seroprevalence among the cohort at baseline and at the end of the~          study.~   "
179247|NCT01218750|"~     The purpose of this study is to evaluate the safety end efficacy of combined~     phakoemulsification and vitrectomy with retinal endophotocoagulation and intraoperative use~     of bevacizumab in patients with diffuse diabetic macular edema (DDME), to determine the~     possible preoperative and intraoperative factors that might influence surgical outcomes.~   "
179248|NCT01218737|"~     The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and~     1.0% prednisolone acetate association in eye drops in the prevention of infection and~     inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the~     efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0%~     prednisolone acetate as isolated eye drops formulations. The study treatment is randomized,~     double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days~     of study treatment administration after the ocular surgery is performed. Candidates for the~     study are patients with indication for ocular refractive surgery (Lasik) for correction of~     visual acuity.~   "
179236|NCT01218893|"~     Malaria is one of the major infectious diseases in the world with a tremendous impact on the~     quality of life significantly contributing to the ongoing poverty in endemic countries. It~     causes almost one million deaths per year, the majority of which are children under the age~     of five. The malaria parasite enters the human body through the skin, by the bite of an~     infected mosquito. Subsequently, it invades the liver and develops and multiplies inside the~     hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the~     blood stream, causing the clinical phase of the disease.~      As a unique opportunity to study malaria immunology and efficacy of immunisation strategies,~     a protocol has been developed in the past to conduct experimental human malaria infections~     (EHMIs). EHMIs generally involve small groups of malaria-naïve volunteers infected via the~     bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although potentially~     serious or even lethal, P. falciparum malaria can be radically cured at the earliest stages~     of blood infection where risks of complications are virtually absent.~      The investigators have shown previously that healthy human volunteers can be protected from a~     malaria mosquito (sporozoite) challenge by immunization with sporozoites (by mosquito bites)~     under chloroquine prophylaxis (CPS immunization). However, it is unknown how many mosquito~     bites are necessary to confer protection. Moreover, as all volunteers were protected in this~     study, no correlates of protection could be established. For future development of vaccines~     and understanding of protective immunity to malaria, it is important to investigate the~     lowest dose of CPS immunization that confers 100% protection and to find correlates of~     protection. Therefore, the present study aims to make the CPS immunization protocol more~     sensitive by lowering the number of infected mosquito bites, in order to study the underlying~     mechanisms of protection.~   "
179237|NCT01218880|"~     Phase I trail will be conducted to evaluate the safety of M2ES in combination with~     gemcitabine in locally advanced or metastatic pancreatic cancer.~   "
179238|NCT01218867|"~     Background:~      The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for~     treating patients metastatic cancer that involves taking white blood cells from the patient,~     growing them in the laboratory in large numbers, genetically modifying these specific cells~     with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells~     back to the patient. This type of therapy is called gene transfer. In this protocol, we are~     modifying the patient s white blood cells with a retrovirus that has the gene for~     anti-vascular endothelial growth factor receptor (VEGFR2) incorporated in the retrovirus.~      Objectives:~      - To determine a safe number of these cells to infuse and to see the safety and effectiveness~     of cell therapy using anti-VEGFR2 gene modified tumor white blood cells to treat recurrent or~     relapsed cancer.~      Eligibility:~      - Individuals greater than or equal to 18 years of age and less than or equal to 70 years of~     age who have been diagnosed with metastatic cancer that has not responded to or has relapsed~     after standard treatment.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of~          Health (NIH) clinical Center and undergo a history and physical examination, scans,~          x-rays, lab tests, and other tests as needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti-VEGFR2 cells.~          {Leukapheresis is a common procedure which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown the patients will be admitted to the hospital for~          the conditioning chemotherapy, the anti-VEGFR2 cells and aldesleukin. They will stay in~          the hospital for about4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up~          to 2 days.~   "
179239|NCT01218854|"~     Background:~      - Currently, standard procedures for biopsies that are guided by computed tomography (CT)~     imaging involve CT scans and a computer program to plan and illustrate where the physician~     will place the needle to obtain the required cells or tissue. Inserting the biopsy needle at~     the planned angle is not an easy task, because the appropriate angle of insertion must be~     estimated based on prior experience. Researchers are studying experimental techniques that~     might provide better guidance about the right angle to insert the biopsy needle and thereby~     improve the collection of the appropriate biopsy cells or tissue.~      Objectives:~      - To evaluate the effectiveness of two biopsy needle guidance methods in CT-guided tissue~     biopsy.~      Eligibility:~      - Individuals at least 18 years of age who are scheduled to have CT-guided tissue biopsy.~      Design:~        -  Participants will have a tissue biopsy guided by CT scans and either a laser system or a~          plastic block to illustrate the appropriate angle of insertion. The skin will be numbed~          with anesthetic to minimize discomfort during the procedure.~        -  Before inserting the biopsy needle, the study physician will hold the needle in place so~          that a Food and Drug Administration-approved medical GPS (electromagnetic tracking)~          system can measure the needle angle as it enters the tissue.~        -  After the needle angle data has been collected, researchers will proceed with the actual~          biopsy procedure as it would normally occur, using standard methods.~        -  No additional treatment will be provided as part of this protocol.~   "
179240|NCT01218841|"~     Surgical trauma can lead to an intense inflammation and impairment of the capacity to fight~     against infections. Fish oil is composed by substances called omega-3 fatty acids which have~     anti-inflammatory effects. When infused through the vein as part of a nutritional treatment~     of some surgical patients, fish oil have been shown to preserve some defense capabilities~     against infections and to decrease postoperative release of inflammatory substances,~     contributing to the shortening of length of hospital and intensive care unity (ICU) stay and~     complications, mainly infectious complications. These reported benefits have been encouraging~     the vein infusion of fish oil as a kind of medicine to contribute for the treatment of~     surgical patients. In current study the investigators evaluated the effect of preoperative~     infusion of pure fish oil in patients with gastrointestinal cancer (stomach and colon) on~     their clinical outcomes. The hypothesis considered that preoperative infusion of fish oil,~     not as part of nutritional therapy but as a medicine agent, can attenuates inflammation and~     improves the capacity of surgical patients to fight against infections, improving their~     treatment.~   "
179241|NCT01218828|"~     Using a randomized controlled trial design, two hydration protocols for the prevention of~     contrast medium-induced nephropathy will be tested.~   "
179242|NCT01218815|"~     CORAMI trial is a prospective, international, multicenter randomized study which will be~     performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary~     intervention) duty and patient enrollment will continue for 18 months (October 2010 - March~     2012).The aim of the study is to compare strategy of complete vs target lesion-only primary~     PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.~   "
179243|NCT01218802|"~     The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in~     decreasing cardiovascular risk and bone loss in the HIV+ population.~   "
179244|NCT01218789|"~     The purpose of this study is to evaluate the safety of a one year open-label treatment of~     tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.~   "
179245|NCT01218776|"~     The International Registry of Acute Coronary Syndromes registry study in Transitional~     Countries (ISACS-TC) is both a retrospective and prospective study which was designed in~     order to obtain data of patients with acute coronary syndromes in countries with economy in~     transition, and herewith control and optimize internationally guideline recommended therapies~     in these countries Further study details as provided by the CINECA~     http://isacs-ct.cineca.org/~   "
179249|NCT01218724|"~     Objective:~      to compare the single dose bioavailability of Torrent's Losartan Potassium and~     Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck & Co.,~     Inc.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects~   "
179250|NCT01218711|"~     Objective:~      to compare the single dose bioavailability of Torrent's Losartan Potassium and~     Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck & Co.,~     Inc.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects~   "
179251|NCT01218698|"~     Objective:~      compare the single dose bioavailability of Torrent's Losartan Potassium Tablets 1 × 100 mg~     and Cozaar® Tablets 1 × 100 mg of Merck & Co., Inc.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects~   "
179252|NCT01218685|"~     The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted~     vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised~     disease, elderly and pregnants. The primary immunological endpoint is to analyze the~     proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition~     assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21~     days after vaccination. Volunteers will be recruited based on inclusion and exclusion~     criteria. Vaccine composition is: 15 micrograms of split inactivated virus~     (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is~     safe and immunogenic in the volunteers recruited.~   "
179253|NCT01218672|"~     The study will compare procedural and post procedural outcomes for photoselective~     vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). The~     study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE~     marked monopolar or bipolar loop TURP system for the treatment of benign prostatic~     hyperplasia (BPH). The purpose of the study is to demonstrate that PVP is not inferior to~     TURP.~   "
179254|NCT01218659|"~     Study to compare the efficacy and safety of AT1001 and enzyme replacement therapy (ERT) in~     male and female patients with Fabry disease who are currently receiving ERT and who have~     AT1001-responsive GLA mutations.~   "
179255|NCT01218646|"~     The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the~     licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the~     investigational TIV containing the alternate B strain in adult subjects.~      Primary Objective:~        -  To demonstrate non-inferiority of antibody responses to QIV compared with licensed~          2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the~          alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the~          four virus strains separately among subjects 65 years of age and older~      Observational Objective:~        -  To describe the safety profiles of TIV among subjects 18 years of age and older and QIV~          in subjects 65 years and older, as assessed by solicited injection site and systemic~          adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events~          collected from 21 days post-vaccination, and adverse events of special interest and~          serious adverse events (SAEs) collected from Visit 1 to Visit 2.~   "
179256|NCT01218633|"~     Multiple studies have examined the effect of endogenous GLP-1 secretions by using a~     competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However,~     the presence of an effect does not necessarily imply that this effect is due to the blockade~     of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic~     concentrations of Exendin may have effects of its own. To examine the effect of Exendin on~     glucose metabolism the investigators propose a dose-response study to determine whether the~     compound has effects in a dose-dependent fashion.~   "
179257|NCT01218620|"~     This randomized phase I trial studies the side effects and best dose of RO4929097 in treating~     patients with advanced solid tumors. RO4929097 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
179258|NCT01218607|"~     Volume overload due to left-to-right shunting in patients with atrial septal defect type~     secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular~     resistance can be assessed non-invasively using bicycle stress echocardiography. By measuring~     cardiac output and pulmonary artery pressures at different stages of exercise, a~     pressure-output plot can be obtained. The slope of the pressure-output plot reflects~     pulmonary vascular resistance. In patients undergoing ASD repair after the age of 40 years,~     pulmonary vascular resistance was higher when compared to age-matched controls, indicating~     the presence of mild pulmonary vascular disease. Bosentan has been shown to decrease~     pulmonary vascular resistance.~      The investigators hypothesize that in patients with an ASD type secundum, who underwent ASD~     repair after the age of 40 years, administration of bosentan decreases pulmonary vascular~     resistance as assessed by bicycle stress echocardiography.~   "
179259|NCT01218594|"~     To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy~     (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).~   "
179260|NCT01218581|"~     To date, there is no uniform agreement on the most appropriate therapeutic methods for~     managing women with uterine adenomyosis and/or adenomyoma who want to preserve their~     fertility. Management with hormonal treatment that aims to reduce the proliferation of~     endometrial cells is promising, but there is a paucity of well-designed studies to guide~     treatment. There is a strong need to develop pharmacological agents that provide an efficient~     outcome. Gonadotripn releasing hormone analogues (GnRHa) have been used in several studies,~     to produce a constant hypoestrogenic state in a woman with adenomyosis which cause~     amenorrhoea, control of pain and uterine shrinkage . Pure antiestrogens, however, may offer~     some advantage in the treatment of adenomyosis and trials are required to assess its~     usefulness. Leiomyoma and uterine volumes were successfully reduced by use of aromatase~     inhibitors (AIs). Assuming aromatase production activity in the adenomyosis lesion, Kimura et~     al, used GnRHa and an AI concomitantly for treatment of uterine adenomyosis. This lack of~     information stimulated us to run this trial to compare the efficacy of aromatase inhibitor~     vs. GnRHa in treating premenopausal women with uterine adenomyosis.~   "
179300|NCT01218061|"~     The main objective of the study is to follow prospectively a cohort of patients with~     pre-diabetes to understand the pathophysiological mechanisms involved in switching from~     pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in~     this population.~   "
179261|NCT01218568|"~     The study will be double blind with respect to rifaximin, and randomization will be performed~     using tables of computer-generated random numbers. All subjects will be followed up till the~     recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group~     (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient~     passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group~     (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose.~     Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10~     days will be continued on the same treatment. Total duration of the study is 1 year.~   "
179262|NCT01218555|"~     The purpose of this study is to study the combination of two anticancer drugs, everolimus~     (RAD001) and lenalidomide in patients whose cancer is no longer responding to standard~     treatment or patients who are unable to tolerate the standard treatment for their cancer.~   "
179263|NCT01218542|"~     Brain metastases are the most common adult intracranial tumor, occurring in approximately 10%~     to 30% of adult cancer patients, and represent an important cause of morbidity and mortality.~     The most widely used treatment for patients with multiple brain metastases is whole brain~     radiation therapy (WBRT). The use of WBRT after resection or stereotactic radiosurgery (SRS)~     has been proven to be effective in terms of improving local control of brain metastases.~      RapidArc (RA) (Varian Medical Systems, Palo Alto, CA) is a new method of delivering radiation~     that uses arcs to deliver highly conformal intensity modulated three dimensional dose~     distributions. The purpose of this investigation is to evaluate an alternative strategy for~     giving WBRT with highly focal boost to gross visible lesions in patients with brain~     metastasis.~      Given the limitations of the SRS boost technique, the purpose of our investigation is to~     evaluate an alternative strategy for giving WBRT with highly focal boost to gross visible~     lesions in patients with brain metastasis. In this study, we plan to assess the tolerability~     of using volumetric modulated arc therapy (RapidArc) on patients with brain metastasis to~     simultaneously treat the entire brain with a concomitant focal boost to grossly identified~     lesions on MRI scan to try to improve local control and reduce neurocognitive toxicities.~      This previous version of this study was a phase I dose escalation trial giving 25 Gy in 10~     fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10~     fractions to gross brain metastatic disease. Prior to this, patients were enrolled onto one~     of two cohorts with whole brain dose of 30 Gy in 10 fractions with SIB to total of 45 Gy in~     10 fractions to gross brain metastatic disease or whole brain dose of 37.5 Gy in 15 fractions~     with SIB to total of 52.5 Gy in 15 fractions to gross brain metastatic disease. A total of 12~     patients have been previously enrolled on this trial. No patients have experienced a dose~     limiting toxicity (grade 3 or above) at least possibly due to study therapy. Also, no~     patients experienced local brain failure/progression at a site of treated metastatic brain~     disease. Based on this, we no longer feel that dose escalation to the gross brain disease is~     warranted and would proceed with a single arm pilot study treating patients with 25 Gy in 10~     fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10~     fractions to gross brain metastatic disease.~   "
179264|NCT01218529|"~     This phase II open-label study will be performed to evaluate the response rate of brain~     metastases from lung and breast tumors under treatment with WBRT and lapatinib.~   "
179265|NCT01218516|"~     The primary objective of this study is to compare the effect of farletuzumab versus placebo~     in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent~     (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on~     investigator-assessed progression free survival (PFS) as determined by Response Evaluation~     Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new~     occurrence of positive fluid cytology) in chemotherapynaive participants with folate~     receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.~   "
179266|NCT01218503|"~     This study is designed to determine whether obese, normal weight, and successful weight loss~     maintainers differ in their food choice decision-making and/or executive function, and~     whether participation in a behavioral weight loss program leads to neural and/or behavioral~     changes. The investigators will examine behavioral performance on several tasks involving~     decision-making and self-control in conjunction with brain imaging data acquired during a~     food-choice decision-making task. Participants enrolled in the behavioral weight loss program~     will also be assessed following the treatment.~   "
179267|NCT01218490|"~     It is a multicenter randomized trial of superior cleaning compared the absence of dissection~     in stage III patients with optimal surgical resection without retroperitoneal lymph node~     palpable.~   "
179268|NCT01218477|"~     The purpose of the study is to determine the safety and tolerability of the combination of~     BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.~   "
179269|NCT01218464|"~     Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. and~     liver transplantation is the only available therapeutic option for patients suffering with~     this condition. However, lack of donors, surgical complications, rejection, and high cost are~     serious problems. Previous study showed that bone marrow derived mesenchymal stem cells~     (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver~     failure and contribute to liver regeneration. In this study, the patients with LF will~     undergo administration of human umbilical cord mesenchymal stem cells (UC-MSCs) via~     peripheral vein transfusion to evaluate the safty and efficacy of UC-MSCs treatment for these~     patients.~   "
179270|NCT01218451|"~     The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C~     in infants (at either 4 or 6 months of age), as determined by immune response.~   "
179271|NCT01218438|"~     The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation~     for the treatment of patients with primary immunodeficiency diseases (PIDD).~   "
179272|NCT01218425|"~     A recent study at our lab showed increased episodic memory consolidation and response~     readiness after treatment with methylphenidate in healthy volunteers. The investigators seek~     to replicate and extend these findings. Furthermore the pharmacological specificity of these~     effects will be studied. Since methylphenidate has an effect on two neurotransmitters,~     dopamine and noradrenaline, either could be responsible for the observed effects. In order to~     explore the dopaminergic contribution to this effect, the study proposed here includes not~     only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not~     noradrenaline.~      In this study, 20 healthy males and females between 18 and 45 years of age will participate.~     They will be recruited via advertisements at Maastricht University and in local newspapers.~      Participants will be treated once with methylphenidate, once with levodopa/carbidopa and once~     with placebo. All medications will be administered orally with a capsule.~      It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic~     memory consolidation and improve response readiness~   "
179288|NCT01218217|"~     SQ109 was developed with the aim of shortening TB treatment and providing new drugs for~     resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable~     safety profile in first-in-man studies. The objective of this study is to evaluate the~     extended early bactericidal activity (EBA), safety, tolerability, and pharmacokinetics of~     several doses of SQ109 with or without Rifampicin (RIF) for 14 days in adults with newly~     diagnosed, uncomplicated, smear positive, pulmonary TB.~   "
179273|NCT01218412|"~     The specific aims of the proposed study are:~        -  1. To determine if web-based Motivational Interviewing (MI) is effective, compared to an~          informational web-based comparison group, in enhancing physical activity (PA)~          participation; and~        -  2. To assess the mechanisms by which web-based MI enhances PA through changes in~          targeted cognitive mediators.~      The specific hypotheses of the study include that:~        -  Hypothesis 1: Web-based MI will increase PA;~        -  Hypothesis 2: Web-based MI will lead to stage progression in the direction of increased~          readiness to participate in PA;~        -  Hypothesis 3: Web-based MI will influence theoretically identified cognitive variables;~        -  Hypothesis 4: Cognitive variables will mediate increases in PA participation.~   "
179274|NCT01218399|"~     This is an investigator-initiated study in which Dr. Nadeau wrote the protocol and received~     funding from an Astra Zeneca grant to direct, perform, and monitor the study on her own with~     Stanford staff. We hypothesize that the budesonide/formoterol combination improves the~     efficacy of budesonide alone.~   "
179275|NCT01218386|"~     The present study is set up to evaluate the efficacy of a programmation by administration of~     estrogen valerate during 6 or more consecutive days. In this prospective randomised trial, we~     study the impact of administration of Progynova® during 6, 7,8 9 or 10 consecutive days~     during the luteo-follicular transition period of the menstrual cycle.~   "
179276|NCT01218373|"~     The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects~     of continuous assistance offered by the HOMESWEETHOME services to older people living~     independently. The trial will test the hypothesis that while providing a level of safety~     equivalent to or better than that enjoyed in older people‟s homes, there is a significant~     positive effect on the quality of life (QoL) and the duration of independently living of~     older people.~   "
179277|NCT01218360|"~     This is an observational study to determine the prevalence of moderate to severe Crohn's~     disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a~     standard clinical practice.~   "
179278|NCT01218347|"~     This study aimed to explore the influence of organic anion transporting polypeptide1B1~     (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after~     rosuvastatin administration.~   "
179279|NCT01218334|"~     The proposed study is a two-arm, randomized, single-blinded, cross-over Phase III clinical~     trial in which patients in 3 distinct clinical scenarios will receive the 12LEG, followed by~     the standard ECG, or vice-versa. Each participant will then apply the Hand ECG themselves.~     The 3 clinical scenarios will be: 1. patients at preoperative assessment for elective cardiac~     catheterization or electrophysiology procedures; 2. patients coming for outpatient cardiology~     appointments; 3. Inpatients admitted with a cardiac diagnosis.~      The electrophysiologists reviewing ECGs will be blinded to the equipment utilized to obtain~     the ECG.~   "
179280|NCT01218321|"~     This study is based on the hypothesis that antiepileptic drugs (other than Valproic acid)~     have an effect on the mitochondrial oxidative phosphorylation.~      The objective of this study is to evaluate this effect in an accessible tissue—human~     peripheral white blood cells.~   "
179281|NCT01218308|"~     This study is designed to test the efficacy of an investigational influenza vaccine, in~     children compared to Havrix®, a licensed Hepatitis A virus vaccine.~      This study will also evaluate the immunogenicity and safety of the investigational vaccine.~   "
179282|NCT01218295|"~     Many studies suggest that inspiratory muscles training by means of normocapnic hyperpnea~     improves exercise tolerance in healthy subjects. No information is available about the use of~     this training in COPD patients even if other methods (such as threshold loading and resistive~     loading) have been shown to be effective in terms of Inspiratory Muscle Function,~     Health-Related Quality of Life and Exercise Tolerance.~      This study is designed to evaluate the effects of normocapnic hyperventilation by means of~     Spirotiger®, an instrument training the respiratory muscles, avoiding hypocapnia (using the~     methodology of isocapnic hyperpnoea)in COPD patients.~   "
179283|NCT01218282|"~     Exercise training is the key component of respiratory rehabilitation.The success of long-term~     program resides in the integration between exercise prescription and patients'compliance with~     home training. This can be difficult for patients, especially in terms of understanding the~     exercise intensity.~      This study is designed to evaluate different methods of exercise training at home, to help~     understanding and maintaining the walking intensity in COPD patients. Outcome: exercise~     performance, daily physical activity and respiratory function.~   "
179284|NCT01218269|"~     This study will assess the nitinol U-clip as an alternative to conventional microsurgical~     suture for arterial anastomoses in free tissue transfer.~   "
179285|NCT01218256|"~     Skeletal muscle accounts for up to 40% of the total body weight and is responsible for~     approximately 75% of the whole body insulin-stimulated glucose uptake. Resistance training~     has been shown to improve insulin-stimulated glucose uptake in patients with T2DM. Therefore~     the investigators aim to compose the effects of 2 different resistance training protocols in~     combination with aerobic endurance training (AET) on muscle strength, muscle mass and~     glycemic control in type 2 diabetes mellitus patients (T2DM).~      The investigators aim to perform an 8 week randomized controlled training intervention in 32~     T2DM patients. Patients will be randomly assigned to AET (cycle ergometer, 60-70% of heart~     rate reserve) combined with hypertrophy resistance training (HRT, n=16, 2 sets, 10-12~     repetitions, 70% of the one-repetition maximum) or with endurance resistance training (ERT,~     n=16, 2 sets, 25-30 repetitions, 40% of the one-repetition maximum). Body composition, blood~     analyses, physical work capacity and muscle strength will be measured pre- and~     post-intervention.~   "
179286|NCT01218243|"~     To evaluate efficacy of BL33 for mild and moderate benign prostatic hyperplasia(BPH).There~     are trials showing that electroacupuncture on BL33 for mild and moderate BPH is more~     effective than terazosin. It could reduce the International Prostate Syndrome Score (IPSS) by~     6.68±2.84(39.79%),lower urinary symptoms bother of score(BS) and bladder residual urine, and~     increase maximum urinary flow rate.But the efficacy of BL33 has not been studied. The~     objective of this study is to evaluate efficacy of BL32 for mild and moderate BPH by~     comparison with non-acupoint group.~   "
179287|NCT01218230|"~     Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic~     myopia~   "
179289|NCT01218204|"~     This study investigates the safety, pharmacokinetics and effects of GSK1292263 when taken~     alone or when co-dosed with atorvastatin to subjects with dyslipidemia.~   "
179290|NCT01218191|"~     The aim of this study is to describe acute neurocardiogenic injury after subarachnoid~     hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first~     week and the first six months after SAH.~      The study hypothesis is that the evolution of the cardiac disturbances follows the clinical~     evolution.~   "
179291|NCT01218178|"~     Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and~     therapeutic procedures in interventional cardiology, especially in the acute setting of~     primary PCI. The investigators will test the efficacy of sodium bicarbonate (NaHCO3) and~     N-acetylcysteine (NAC) on the prevention of acute events and CIN in patients with acute~     myocardial infarction.~   "
179292|NCT01218165|"~     Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part~     of the aging process, including immunosenescence, is explained by an imbalance between~     inflammatory and anti-inflammatory networks, wich results in the low grade chronic~     pro-inflammatory status termed inflammaging. It can contribute to a number of age-related~     chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis).~     Prevention or delay in onset of chronic diseases can potentially benefit a large segment of~     the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade~     inflammation through improvement of the gut barrier function and gut microbiota composition~     in elderly people with low-grade inflammation.~   "
179293|NCT01218152|"~     Neurofibromatosis type 1 (NF1) is a frequent autosomal dominant disorder, caused by~     heterozygous mutations of the NF1 tumor suppressor gene (chr.17q11.2). One of the main~     clinical features is the development of benign and malignant tumors. The most common benign~     tumors in these patients are tumors of the peripheral nerve, named neurofibromas. Every NF1~     patient has a life time risk of 8-13% to develop a malignant peripheral nerve sheath tumor~     (MPNST) starting from a pre-existing neurofibroma. MPNSTs lead to a bad prognosis for the~     patient, with an overall five-year survival of less than 25%. Complete resection is the~     standard treatment, but this is often difficult due to the size of the tumors and the~     location on important nerves, moreover the tumor is frequently metastatic at the time of~     diagnosis. For MPNSTs, like for other cancers, the extent and the spread of the disease at~     time of diagnosis is an important factor in determining treatment outcome. In this regard,~     the analysis of tumor derived cell-free circulating DNA in plasma of NF1 patients would open~     up the possibility to diagnose and monitor the development and progression of MPNSTs using a~     small blood sample. In cooperation with P. Schöffski (UZLeuven), we plan to collect blood~     samples from cancer patients to optimize the DNA extraction procedure starting from plasma~     samples. It is known that patients with cancer have a higher amount of free circulating DNA~     in plasma than individuals without cancer and therefore we want to optimize the DNA~     extraction procedure on plasma from patients with cancer. In the meantime, matching MPNST and~     plasma samples from NF1 patients will be collected and sent to us from the University of~     Eppendorf (Victor Mautner) to optimize the array CGH protocol for the detection of copy~     number changes in plasma DNA of NF1 patients with MPNSTs.~   "
179294|NCT01218139|"~     Neurofibromatosis type 1 (NF1) is a frequent, autosomal dominant disorder caused by~     heterozygous mutations (intragenic or microdeletion) of the NF1 tumor suppressor gene~     (chr.17q11.2). One of the clinical features is the development of benign and malignant~     tumors. The most common benign tumors in these patients are tumors of the peripheral nerve~     sheath, named neurofibromas (cutaneous, subcutaneous and plexiform). Every NF1 patient has a~     life time risk of 8 to 13% of developing a malignant peripheral nerve sheath tumor (MPNST)~     out of a pre-existing neurofibroma. In patients with a NF1 microdeletion (5% of NF1~     patients), this risk is even twice as high compared to patients with an intragenic mutation.~     MPNSTs lead to a bad prognosis for the patient, with an overall five-year survival of less~     than 25%. To know more about the development and progression of these tumors, they will be~     screened by microarray comparative genome hybridization (Leuven) and full exome sequencing~     (Leuven). Further experiments will be done in cooperation (bidirectional) with the foreign~     labs of Victor Mautner (Germany), André Bernards (USA), Karen Cichowski (USA) and Yuan Zhu~     (USA).~      For all these experiments, we will make use of tumoral rest material removed from NF1~     patients.~   "
179295|NCT01218126|"~     Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of~     losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance.~     Eligible subjects will be randomised to treatment after a one-week run-in period. The~     duration of the treatment period is 24 weeks. An estimated 1000 subjects will be screened to~     reach the target enrolment of approximately 600 randomised subjects.~   "
179296|NCT01218113|"~     This study is designed to determine whether administration of the GSK Biologicals HIV vaccine~     732462 can lead to a reduction in viral load, and impact on the course of human~     immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet~     started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the~     initiation of treatment.~   "
179297|NCT01218100|"~     This study will evaluate the safety and efficacy of first-line treatment with a free~     combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2~     diastolic hypertension (DBP>= 100 mmHg).~   "
179298|NCT01218087|"~     Many hospitalized infants can develop a flattening of the back or sides of their head. This~     condition develops gradually when an infant's head rests on a firm or semi-firm surface for a~     prolonged period of time. Premature infants are more likely to have a positional head shape~     deformity because they may spend longer periods of time in a crib. Infants participating in~     this study will be randomly assigned to either standard treatment, which is a moldable~     positioner device, or to a cranial cup device and moldable positioner for positioning. The~     purpose of this prospective single-blinded randomized clinical trial will be to evaluate the~     effectiveness of the cranial cup in preventing positional head shape deformity in the NICU~     patient population.~   "
179299|NCT01218074|"~     Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs.~     This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The~     investigators test the hypothesis that routine use of aggregometry could show antiaggregated~     patient and lead to normalization of platelet function via administration of Desmopressin~     thus limiting bleeding and transfusions.~   "
179330|NCT01217671|"~     This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study~     evaluating the safety and efficacy of Kamada AAT for inhalation in patients with Emphysema~     caused by Alpha-1 Antitrypsin (AAT) deficiency.~   "
179301|NCT01218048|"~     There are currently no useful tests to identify patients who will respond to cetuximab~     therapy, notably because EGFR levels do not correlate with the clinical responses observed.~     Thus, the investigators are investigating the role of cellular immunity and immune escape~     mechanisms to explain the differential clinical response to cetuximab.~   "
179302|NCT01218035|"~     This is a randomized, double-blind and placebo-controlled study to evaluate the efficacy of~     zoledronic acid on the biologic incorporation of cementless hip prosthesis in postmenopausal~     female patients.The study population consists of postmenopausal female patients scheduled for~     total hip replacement because of degenerative hip osteoarthritis. The patients will receive~     either a single dose of 5 mg zoledronic acid or placebo intravenously after surgery before~     hospital discharge. The patients will be followed-up for 1 year. Zoledronic acid therapy has~     been shown to promote bone ingrowth into porous implants in pre-clinical models. The~     investigators hypothesis is that zoledronic acid, given as a single intravenous infusion~     after hip replacement surgery, enhances bone ingrowth into porous surface of cementless hip~     prostheses. As a primary outcome, the therapy is expected to reduce periprosthetic bone loss~     measured by DXA. Enhancement of bone ingrowth is expected to increase primary stability of~     the hip prosthesis and this effect can be detected with high-precision three-dimensional RSA~     imaging modality and in a faster functional recovery of the patients.~   "
179303|NCT01218022|"~     Objective:~      The purpose of this study is to compare the single dose bioavailability of Torrent's Losartan~     Potassium Tablets 1 × 100 mg and Cozaar® Tablets 1 × 100 mg of Merck & Co., Inc.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects.~   "
179304|NCT01218009|"~     This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After~     a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol~     or a dummy drug at regular times four times a day. Then for the last nine months of the~     study, all subjects will be given the albuterol dry powder inhaler and will use it only when~     needed to help with breathing problems. Subjects will need to keep a daily diary (both paper~     and electronic) throughout the study recording any inhaler use and health problems. There~     will be visits to the study doctor about once a month for a year. This study is intended to~     show that the albuterol dry powder inhaler works well and is safe for use over a long period~     of time.~   "
179305|NCT01217996|"~     Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) show elevated~     rates of working memory impairment. Working memory (WM) is the ability to hold and manipulate~     information online; for example, when an individual mentally rehearses a phone number in~     order to dial it without writing it down. A computer-based working memory intervention has~     been successful in children diagnosed with ADHD and stroke survivors. Individuals~     participating in the intervention showed improvements on working memory measures as well as~     more complex problem solving skills. Neuroimaging (brain scans) conducted before and after~     training showed changes in brain activation suggestive of underlying changes in brain systems~     that support working memory. This study investigates the effectiveness of this computer-based~     working memory intervention for childhood cancer survivors.~   "
179306|NCT01217983|"~     Evaluation of kidney function is critical in cirrhotic patients as there is a clear~     relationship between renal failure and prognosis. The investigators hypothesized that in this~     population new biomarkers of renal function could help in early detection of acute renal~     failure and in discrimination between renal and pre-renal causes. Finally the investigators~     hypothesized that such biomarkers could predict short-term outcome in this population.~   "
179307|NCT01217970|"~     This study is designed to collect data to determine whether a medication, ibudilast, is safe~     for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan~     and South Korea, ibudilast has been used safely in humans as a treatment for asthma,~     pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in~     outpatient settings with people who have methamphetamine dependence. This would be the first~     study to collect this information. This study is important because individuals with~     methamphetamine dependence often relapse to meth use, even when in treatment; some number of~     individuals who participate in an outpatient study will relapse to methamphetamine while~     taking ibudilast. It is crucial to know whether there may be interactions between ibudilast~     and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting~     medication candidate for treating methamphetamine dependence. When individuals become~     abstinent from methamphetamine during early recovery, the body starts an inflammatory process~     in neurons, especially glial cells. Glial cells are important in that they provide support to~     the nerve cells that are involved in thought, movement, and other human activities. By~     dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells~     during early abstinence, which in turn may help individuals feel better and think better~     during treatment.~      The study specific aims are to determine whether ibudilast alters:~        1. blood pressure and heart rate responses to methamphetamine;~        2. the ratings of craving or other drug experiences from methamphetamine;~        3. the reward/reinforcing effects of methamphetamine; and~        4. the metabolism of methamphetamine.~      Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not~     looking for treatment will complete this study.~   "
179308|NCT01217957|"~     The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum~     tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in~     combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed~     multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the overall~     response rate (ORR) and further evaluate the tolerability and toxicity of the combination of~     oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with NDMM.~   "
179309|NCT01217944|"~     This study is designed to evaluate the efficacy and safety of two different dosing regimens~     of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in~     patients with visual impairment due to choroidal neovascularization (CNV) secondary to~     pathologic myopia (PM).~   "
179310|NCT01217931|"~     The goal of this clinical research study is to compare 6 different 2-drug sequences of~     everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer.~     For the 2-drug sequence, participants will receive 1 of these drugs and may start taking~     another of these drugs after that. Researchers will also study the safety of these 2-drug~     sequences.~   "
179311|NCT01217918|"~     Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when~     administered to healthy Japanese subjects once a day (QD) for 10 days.~   "
179312|NCT01217905|"~     This is a study in Japanese healthy volunteers to determine the safety and tolerability of~     the compound AZD7687. It will also assess how the body handles the drug and how it responds~     to the drug following single dose followed by multiple dosing over 7 days.~   "
179378|NCT01217047|"~     This research is being done to study the effect of Functional Electrical Stimulation (FES)~     cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).~   "
179313|NCT01217892|"~     This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5~     mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is~     beneficial in diabetes treatment, and if so, how it compares to treatment with metformin~     alone.~   "
179314|NCT01217879|"~     In the light of ONTARGET and TRANSCEND studies results, it would be interesting to~     investigate the real-life telmisartan treatment tolerability. It is well known and accepted~     that the Real-life setting is much more adequate to reflect the antihypertensive and safety~     properties of the drug in comparison to the organized and scheduled setting of the clinical~     trial. Because there are not much data on the cough in relation to telmisartan, therefore it~     would we worth to observe the cough frequency and general treatment tolerance in patients~     treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.~   "
179315|NCT01217866|"~     Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic~     portion of the case used an EN~SEAL device to Group B - the laparoscopic BSO was done using a~     3mm EN-SEAL device through 2 lateral 5mm ports.~   "
179316|NCT01217853|"~     A study in which intraocular pressure (IOP) will be monitored over 24 hours using the~     SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle~     glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP~     patterns emerging from SENSIMED Triggerfish and GAT.~   "
179317|NCT01217840|"~     Large studies of children show that over half of the children in the United States of America~     do not have enough vitamin D stored in their bodies. In children who are overweight or obese,~     the percentage of children who do not have enough vitamin D is even higher.~      Vitamin D is essential for the body to maintain normal calcium levels and strong bones.~     Recent research shows that through the actions of inflammatory markers, levels in the blood~     that measure inflammation in the body, vitamin D plays many other important roles in the body~     like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat.~      The purpose of this study is to determine the effect of vitamin D supplementation on~     inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like~     to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin~     D stores and inflammatory cytokines.~      In an observed, randomized controlled trial over 6 months we will provide observed vitamin D~     supplementation or placebo to healthy obese and overweight adolescents and measure changes in~     inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that~     administration of vitamin D to these patients will improve their inflammatory profile and~     cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).~   "
179318|NCT01217827|"~     Despite being a proven life-saving intervention in appropriately selected individuals,~     multiple studies continue to demonstrate low implantation of defibrillators in potential~     candidates. Based upon prior research, a major barrier to low utilization is low referral of~     potential candidates by healthcare providers. In this study, via brief clinical reminder~     placed in the electronic medical record, we ask healthcare providers who have not referred~     potential candidates for defibrillator the reasons for this decision and provide them with~     the tools for referral if appropriate.~   "
179319|NCT01217814|"~     Primary Objective:~      - To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior~     in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in~     participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α)~     antagonists.~      Secondary Objectives:~        -  To assess the safety of sarilumab;~        -  To document the pharmacokinetic profile of sarilumab.~   "
179320|NCT01217801|"~     The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg~     with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study~     participants under fed conditions.~      The purpose is to monitor clinical status, adverse events, laboratory investigations and to~     assess relative safety and tolerance of ondansetron formulations under fed conditions.~   "
179321|NCT01217788|"~     The purpose of this study is to determine the efficacy of PH94B, a new class of therapeutic~     compound, administered intranasally for the management of acute anxiety in patients diagnosed~     with generalized social phobia.~   "
179322|NCT01217775|"~     The objective of this study is to evaluate the effectiveness and safety in double-blind,~     randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray for~     the acute management of cycle related symptoms in women who regularly experience premenstrual~     dysphoric disorder (PMDD).~   "
179323|NCT01217762|"~     The purpose of this study is to evaluate the safety and clinical feasibility of the IRay~     System for the treatment of wet age-related macular degeneration (AMD).~   "
179324|NCT01217749|"~     The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily~     regimen of orally administered PCI-32765 combined with ofatumumab in subjects with~     relapsed/refractory CLL/SLL and related diseases~   "
179325|NCT01217736|"~     The objective of the study is to determine the magnitude of the effect of direct renin~     inhibition by VTP-27999 on renal plasma flow and kidney function.~   "
179326|NCT01217723|"~     This is a randomized trial for patients undergoing hematopoietic progenitor cell~     transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled~     will receive Thymoglobulin® as part of the preparative regimen prior to HPCT. The other 50%~     of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is known~     to suppress the types of cells that can cause a transplant complication known as chronic~     graft versus host disease (cGVHD). The goal of this trial is to find out if adding~     Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.~   "
179327|NCT01217710|"~     The objective of this project is to validate the proposed smartphone-based activity monitor~     and to test its use for Motivational Interviewing based counseling for physical activity in~     Chronic Obstructive Pulmonary Disease (COPD).~   "
179328|NCT01217697|"~     The purpose of this study is to collect additional safety information on abiraterone acetate~     administered with prednisone to patients with metastatic castration-resistant prostate cancer~     (CRPC).~   "
179329|NCT01217684|"~     The purpose of the present study is to evaluate test-retest reliability of a standard~     protocol on the Biodex dynamometer in older adults.~      In addition, the test-retest reliability and validity of an experimental measure of knee~     extension strength will be assessed in older adults.~   "
179331|NCT01217658|"~     Excessive infant crying (EIC) is likely to increase the risk of child abuse. The~     investigators propose a randomized trial using an intervention based on recommendations of~     Karp. The investigators will systematically identify 170 term infants with EIC and conduct~     assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces~     mean infant hours of night-time crying, increases maternal soothing behaviors and improves~     parental anxiety and depression.~   "
179332|NCT01217645|"~     This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a~     single-dose intravenous administration.~   "
179333|NCT01217632|"~     The overall goal of this trial is to evaluate the efficacy of FG-3019 for reversing liver~     fibrosis in subjects with chronic hepatitis B infection who are beginning antiviral therapy~     with entecavir. This Phase 2 randomized, double-blind, placebo controlled study will enroll~     subjects with chronic active hepatitis B infection and liver fibrosis (Ishak score ≥2) who~     are eligible for antiviral therapy.~   "
179334|NCT01217619|"~     This is a single arm, one center, phaseⅡ study evaluating efficacy and safety of erlotinib as~     neoadjuvent treatment in patients with EBUS confirmed stage ⅢA N2 NSCLC with activating EGFR~     mutation in exon 19 or 21.~   "
179335|NCT01217606|"~     This study will evaluate the safety and efficacy of Triple Combination Therapy compared with~     Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary~     open-angle glaucoma or ocular hypertension.~   "
179336|NCT01217593|"~     The purpose of this study is to compare ultrasound and predetermined distance techniques for~     finding the paravertebral space to inject the local anesthetic (numbing medicine) when you~     are given anesthesia for surgery. The paravertebral space is located on either side of the~     spinal cord and contains the nerves that provide sensation to the chest wall. The~     predetermined distance technique is a series of measurements taken to determine the location~     of the paravertebral space where the local anesthetic is injected. The ultrasound technique~     uses direct visualization of the local anesthetic being placed in the paravertebral space.~     This type of anesthesia has many benefits including decreasing your pain after breast~     surgery.~   "
179337|NCT01217580|"~     The purpose of this study is to determine if injecting a local anesthetic, or numbing~     medication, above each hip will decrease the amount of narcotic pain medicine that is~     typically required by a patient after a cesarean delivery. Ultrasound pictures will be used~     to guide placement of this injection. Either ropivicaine (a type of numbing medication called~     a local anesthetic) or a placebo (saline) will be injected. For 24 hours, you will be given a~     button to press when you have pain. When the button is pressed, you will be given a small~     amount of pain medication called hydromorphone through your IV. You will also be given a pain~     medication called ketorolac through your IV every 8 hours for 24 hours after surgery.~   "
179338|NCT01217567|"~     The Purpose of this study is to compare two methods for closure of the skin after caesarean~     section on the same patient; staples and subcuticular sutures. The study is performed on two~     separate groups of patients: 1. Woman having cesarean section for the first time and have not~     previously had abdominal surgery through a lower abdominal transverse incision. 2. Woman, who~     have previously had a caesarean section done. The following parameters are registered:~        1. An objective evaluation of the two ends of the scar 6 months postoperatively.~        2. A patient evaluation of the two ends of the scar 6 months postoperatively.~        3. The difference in pain in the two ends of the scar 1 day postoperatively (blinded).~        4. The difference in pain in the two ends of the scar 7 days, 3 and 6 months~          postoperatively.~        5. The rate of infection.~   "
179339|NCT01217554|"~     Low back pain (LBP) is considered one of the most common musculoskeletal disorders in modern~     society, resulting in substantial costs to society. Factors associated with the development~     of low back pain include poor posture, strenuous work with the body, inadequate non ergonomic~     work and traumas.~      Rotation movement pattern of the lumbar spine in different positions is essential aspect in~     understanding the LBP Pathophysiology. Rotation coupled with forward bending (flexion) is a~     dominant factor which could increase the risk LBP and disc prolapse. There is also a decline~     in range of motion (ROM) of rotation in forward bending (flexion) compared to neutral~     position during sitting and standing.~      In addition,lumbar rotation movement patterns differ in population with LBP compared to~     asymptomatic individuals. Healthy individuals exhibit rotation accompanied by consistent~     coupled movement patterns of lateral bending in the opposite direction at thr upper levels,~     and by lateral bending in tge same direction at the lower levels . while Chronic LBP patients~     exhibit non consistent patterns altered from those of the normal population.~   "
179340|NCT01217541|"~     Dementia is a serious health problem showing an increasing prevalence rate with increasing~     age. In Norway, about 80% of nursing home patients have dementia. The mean age of nursing~     home residents in Norway is around 84 years. Disruptive and agitated behaviour affect 30-50%~     of all individuals with dementia at some point in the course of the illness. In addition,~     they have a combination of physical and psychological diseases which necessitates a close~     collaboration between different specialities in medicine and Old Age psychiatry. In~     collaboration with the communalities, our Old Age psychiatry services want to provide a new~     approach to this challenge and validate it on patient and personnel level.~   "
179341|NCT01217528|"~     The purpose of this study is to determine efficacy of a dedicated programming concept for~     avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient~     with primary prevention ICD indication.~   "
179342|NCT01217515|"~     A Phase III, multicentre, randomised, double blind, placebo-controlled study in subjects~     having anal fissure (AF) with AF-related pain. Subjects will undertake a 1-week screening~     period to provide baseline data and for assessment of eligibility. At the Baseline visit~     (Week 0), eligible subjects (having an average Numerical Rating Scale (NRS) score of >4 for~     worst pain associated with or following defaecation) will be randomised on a 1:1:1 basis to~     one of the three treatment groups. Subjects will receive diltiazem hydrochloride 2% cream or~     diltiazem hydrochloride 4% cream or placebo cream. Study treatment will be applied in and~     around the anus, three times daily, for up to 8 weeks. Following the Week 0 Visit, subjects~     will be contacted by telephone during Week 1 to ensure adequate compliance with study~     treatment, to ensure that study drug is being tolerated and that any concomitant medications~     are used at a level consistent with that prior to randomisation. Subjects will return to the~     clinic for safety and efficacy assessments at Weeks 2, 4, and 8 and receive a follow-up~     telephone call at Week 12, following cessation of therapy.~      Concomitant laxatives and stool softeners will be permitted, as needed, during the entire~     study period (screening and treatment) to ensure that constipation or passage of hard stools~     does not confound evaluation or improvement of the condition. Fibre supplements will be~     allowed but should be continued at the baseline level.~      Instructions on the use of the Interactive Voice Response System (IVRS) diary will be issued~     to subjects to record fissure-related pain (NRS) and bowel symptoms daily during the 1-week~     screening period, to confirm eligibility and post-randomisation to record worst anal pain~     associated with or following defaecation (NRS) and daily overall AF-related pain (NRS). A~     record of the number of times the subject has defaecated, laxative and analgesic usage will~     also be made as well as the number of applications of study treatment, any changes to~     concurrent medications and any Adverse Events (AEs).~      In addition, at some or all study visits, subjects will record the Patient's Global~     Impression of Improvement (PGI-I) on a 7 point Likert scale, complete a Short Form 36 (SF-36)~     quality of life questionnaire and will undergo examination of their AF. Routine blood samples~     will be taken and the Skin Irritation Score (SIS) recorded for safety evaluations.~      Subjects may receive permitted medications for pain per Entry Criteria, but these should~     remain stable, where possible, up to the Week 8 Visit. Introduction of any new medication for~     AF will not be permitted unless the Investigator deems rescue intervention necessary. A~     subject will be deemed a treatment failure if rescue intervention is required and will have~     to be withdrawn from the study.~      Any subject leaving the study following randomisation for any reason will be asked to~     complete the Early Withdrawal Visit. This includes subjects who withdraw due to the~     development of AEs or intolerance, as well as subjects who require rescue intervention. These~     subjects will return for safety follow-up visits at their previously scheduled follow-up~     assessment appointments. If complete healing has occurred at the 2 or 4 Week visits, (i.e.~     prior to the end of the 8-week treatment period), subjects will be asked to continue applying~     the medication for the full 8 week course, up to the final assessment.~      Following the Week 8 visit (or Early Withdrawal Visit), subjects will be followed up for a~     further 4 weeks (following cessation of study medication) to note any AEs.~      All routine blood analyses (haematology and biochemistry) and plasma levels of diltiazem and~     of its principal metabolites will be analysed by central laboratories.~   "
179343|NCT01217502|"~     This study aims to determine the effectiveness of a self-management program for elderly with~     an acquired and concurrent hearing and visual impairment due to age-related disease~     processes.~   "
179373|NCT01217112|"~     This 15-19 week study is being conducted by GW Pharma Ltd as a pilot study in order to~     determine the efficacy and safety of two cannabinoids: GWP42004 and GWP42003 alone, or in~     combination in patients with Type 2 diabetes. This is the first study to determine whether~     the study medications have a positive benefit for subjects on their cholesterol levels, body~     weight, liver fat content and other metabolic parameters compared with a placebo medication.~   "
179374|NCT01217099|"~     The purpose of this study is planned to investigate whether small doses of methylprednisolone~     pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy~     for refractory mycoplasma pneumoniae pneumonia(MPP) .~   "
179344|NCT01217489|"~     The Signascan Electrical Impedance Mammography (EIM) Study is a pilot study of a non-invasive~     medical device - a novel approach to breast cancer detection using Electrical Impedance~     Mammography (passing minute electrical currents through the tissues and detecting the changes~     to the currents as a result of the tissues, which can differentiate between normal and~     malignant tissue). The trial is a prospective trial of diagnostic capability of the device,~     as compared with standard care (diagnosis provided by the concurrent NHS investigation -~     imaging, surgery etc) performed for female patients attending the symptomatic breast clinic~     for investigation. The aim is to assess the diagnostic efficacy in detecting 100 true~     malignancies, and continue to recruit until 300 patients with true malignancies have been~     recruited if necessary.~   "
179345|NCT01217476|"~     Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development~     code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken~     Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit~     consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent~     for solution and a spray part to fit the glass bottle after reconstitution of the final~     product.~      We conduct a multinational, randomized, double-blind, placebo controlled, parallel-group,~     multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and~     a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior~     wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after a maximum of 12~     weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition~     to best local care (off-loading, dressings). Approximately 210 patients will be randomized~     and it is planned that this study will be conducted at approximately 40 investigational sites~     in Europe.~   "
179346|NCT01217463|"~     Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development~     code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken~     Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit~     consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent~     for solution and a spray part to fit the glass bottle after reconstitution of the final~     product.~      The investigators conduct a multinational, randomized, double-blind, placebo controlled,~     parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment~     phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to~     demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic~     origin after 12 weeks topical daily application of trafermin 0.01% spray compared with~     placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients~     will be randomized and it is planned that this study will be conducted at approximately 30~     investigational sites in an estimated 4 countries in Europe (Czech~     Republic,France,Hungary,Italy,).~   "
179347|NCT01217450|"~     This phase I trial is studying the side effects and the best dose of MEK Inhibitor AZD6244~     when given together with cetuximab in patients with advanced or refractory solid tumors that~     cannot be removed by surgery. MEK inhibitor AZD6244 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. Giving MEK Inhibitor AZD6244 together with cetuximab may kill more tumor cells.~   "
179348|NCT01217437|"~     This randomized phase II trial studies how well giving temozolomide and irinotecan~     hydrochloride together with or without bevacizumab works in treating young patients with~     recurrent or refractory medulloblastoma or central nervous system (CNS) primitive~     neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. It is not yet known whether temozolomide and~     irinotecan hydrochloride are more effective with or without bevacizumab in treating~     medulloblastoma or CNS primitive neuroectodermal tumors.~   "
179349|NCT01217424|"~     RATIONALE: Reflexology and aromatherapy massage may lessen symptoms in patients with cancer.~     It is not yet known whether reflexology is more effective than aromatherapy massage in~     relieving symptoms in patients with cancer.~      PURPOSE: This randomized clinical trial is studying reflexology to see how well it works~     compared with aromatherapy massage in relieving symptoms in patients with cancer.~   "
179350|NCT01217411|"~     This randomized phase I/II trial studies the side effects and the best dose of RO4929097~     (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with~     whole-brain radiation therapy or stereotactic radiosurgery and to see how well it works~     compared to whole-brain radiation therapy or stereotactic radiosurgery alone in treating~     patients with breast cancer or other cancers (such as lung cancer or melanoma) that have~     spread to the brain. RO4929097 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Whole-brain radiation therapy uses high energy x-rays deliver~     radiation to the entire brain to treat tumors that can and cannot be seen. Stereotactic~     radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to~     normal tissue. It is not yet known whether giving RO4929097 together with whole-brain~     radiation therapy or stereotactic radiosurgery may kill more tumor cells.~   "
179351|NCT01217398|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving temozolomide together with bevacizumab~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to see~     how well they work in treating patients with metastatic melanoma of the eye.~   "
179352|NCT01217385|"~     RATIONALE: New imaging procedures, such as diffuse optical spectroscopy imaging, may help~     measure a patient's response and allow doctors to plan better treatment.~      PURPOSE: This clinical trial studies diffuse optical spectroscopy imaging in monitoring and~     predicting response in patients with locally advanced breast cancer undergoing chemotherapy~     before surgery.~   "
179353|NCT01217372|"~     Calcium oxalate nephrolithiasis is a relatively common disease. The prevalence in the general~     population may range from 10 to 12 percent, and 0.4 to 1 percent of new cases are reported~     every year according to different series. Without specific pharmacological therapy, the~     recurrence rate in patient with established diagnosis of nephrolithiasis is extremely high~     and may range from 15 to 20 percent per year, with a cumulative incidence at five years~     ranging from 27 to 50 percent.Although genetic factors play an important role in the~     development of nephrolithiasis, environmental factors such as diet also appear to affect~     stone formation. Potassium citrate is also effective in preventing stone recurrence in~     patients with calcium oxalate nephrolithiasis. Low tolerability, however, may remarkably~     limit the use of these medication. Citrus fruits are a natural rich source of citrate and~     diet supplementation with juice of citrus fruits may represent a valuable alternative option~     to supply citrate without exposing the patients to the adverse effects of citrate containing~     medications. Among the most commonly consumed citrus fruits, lemons contain the greatest~     concentrations of citric acid (49,2 g/Kg);a half cup of pure lemon juice can provide a daily~     amount of citrate comparable to that of a standard daily dose of alkali citrate medications.~      A few studies tried to evaluate the effects of lemon juice supplementation in patients with~     calcium oxalate nephrolithiasis, but the findings were flawed by the retrospective,~     observational design of the study or by the too small sample size that limited the power of~     statistical analyses and the reliability of the results. This study will be primarily aimed~     at evaluating whether lemon juice added to standard diet recommendations compared to diet~     recommendations alone may reduce the risk of new stone formation in patients with recurrent~     idiopathic calcium oxalate nephrolithiasis. Secondarily, the study will evaluate the effects~     of lemon juice supplementation on complications of nephrolithiasis such as urinary tract~     infections, colic symptoms, and hospitalizations for stone disruption or removal, as well as~     the effects on urinary factors (such as urinary citrate, oxalate, calcium excretion or pH)~     that may favor or limit stone formations and the relationships between these effects and the~     risk of stone recurrence.~   "
179354|NCT01217359|"~     Purpose:~      The purpose of this exploratory study is to evaluate phosphoprotein profiling to determine~     differences in the intracellular actions of interferon or interferon stimulated genes among~     people with different treatment outcomes to interferon based therapy for hepatitis C (HCV).~     Participants: Patients with genotype 1 HCV who have had interferon based therapy at the~     University of North Carolina (UNC). Procedures: Thirty patients with varied responses to~     treatment will be given a single subcutaneous injection of interferon alpha 2b. Prior to the~     injection and at 30 minutes, 1,2,4,6,12 and 20 hours after injection, blood will be drawn for~     analysis of phosphoprotein profiling and changes in serum cytokines.~   "
179355|NCT01217346|"~     Cardiac syndrome X consists of a triad of chest pain, abnormal exercise stress testing and~     normal coronary angiogram, and is hypothesized to be related to endothelial dysfunction.~     Endothelial dysfunction is also reported to be linked to obstructive sleep apnea. While chest~     pain can be one of potential presenting symptoms of obstructive sleep apnea, the~     investigators hypothesize that obstructive sleep apnea is common in subjects with cardiac~     syndrome X.~   "
179356|NCT01217333|"~     The investigators community based resource center has implemented visit preparation by~     prompting patients to write down their questions. This is a proven approach to increasing the~     number of questions and concerns that patients voice during their visits with doctors. The~     resource center's usual practice is to provide their visit preparation intervention, called~     Consultation Planning, through in-person counseling sessions. This study asks whether~     telephone delivery of Consultation Planning would be almost as effective in terms of~     increasing patient's decision self-efficacy, or confidence in their ability to navigate~     decisions effectively with their physicians. The study also asks about the cost-effectiveness~     of telephone delivery compared to in-person delivery. The investigators are answering these~     questions through a randomized, controlled, non-inferiority trial with two arms: in-person~     versus telephone delivery of Consultation Planning. The investigators are measuring~     self-reported psychological outcomes such as decision self-efficacy (primary outcome),~     preparation for decision making, anxiety, and distress, along with economic outcomes such as~     health resource utilization and willingness to pay. The investigators hypothesize that~     Tele-CP can be delivered at a lower patient and resource center cost than in-person CP, and~     that it will be as effective in terms of impact on a patient's decisional self-efficacy.~   "
179357|NCT01217320|"~     Creatine supplementation may improve strength, muscle mass, bone mass and muscle function in~     healthy and elderly people. The investigators speculate that creatine supplementation could~     have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus~     and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting~     and bone mass loss.~   "
179358|NCT01217307|"~     The investigators will evaluate the effect of metformin therapy during 4 months in~     non-diabetic patients following ST-elevation myocardial infarction on left ventricular~     ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.~   "
179359|NCT01217294|"~     Pain control after hip replacement surgery is important to ensure patient comfort, allow~     mobilisation, and aid recovery. The investigators propose a simple and pragmatic study~     comparing two different anaesthetic techniques in the provision of pain relief after hip~     surgery. Patients will be randomised to receive either spinal anaesthesia containing morphine~     or spinal anaesthesia without morphine and an ultrasound guided fascia iliaca nerve block.~     Although morphine is an effective pain killer, its side effects include itch, urinary~     retention, nausea and potentially fatal breathing problems. If the nerve block can be shown~     to provide comparable pain relief to spinal morphine, then morphine could be removed from the~     spinal injection. This could reduce side effects and improve patient safety. The~     investigators wish to investigate whether ultrasound guided fascia iliaca plane block~     provides analgesia which is comparable to that of intrathecal opioid for primary hip~     arthroplasty in the first 24 hours after hip replacement surgery~   "
179360|NCT01217281|"~     Periodontal disease is a bacterially-induced inflammation. As such, it can become a point of~     entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely~     affecting the function of kidneys. This is turn can aggravate the condition of patients with~     CKD.~      The study hypothesis is that periodontal therapy can improve renal function in patients with~     CKD and lower the blood levels of markers for systemic inflammation.~   "
179361|NCT01217268|"~     The investigators want to evaluate the use of video-conference in the collaboration between~     the investigators psychogeriatric department and nursing homes. The study aim is to give~     supervision on a regular basis to the caregivers on a special care unit for patients with~     dementia with behavioural disturbances during a period of half a year. The investigators want~     to investigate the impact on caregivers and patients by applying certain tests at baseline,~     during the intervention and half a year after the intervention.~   "
179375|NCT01217086|"~     This is the trial to see how our product is similar to remicade by comparing the results of~     blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or~     parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving~     adequate response to methotrexate alone up to week 30.~   "
179362|NCT01217255|"~     Because of high cost, persons with hemophilia in many developing countries cannot afford~     adequate treatment. For example, many persons with hemophilia in India and China are only~     rarely treated with factor replacement in response to bleeds, and as a result many have~     developed significant arthropathy and disability. A pilot study in China estimated the mean~     Hemophilia Joint Health Score (HJHS) at 13.1 (SD 9.03) suggesting that these children had~     highly prevalent, severe joint disease. The lack of relationship between the HJHS and~     treatment history suggests overall inadequate therapy.~      The proposed study will quantify the burden of arthropathy, physical disability, and quality~     of life (QoL) in boys with hemophilia in Brazil - where comprehensive treatment is just~     beginning to be widely available. This study will also provide an opportunity to compare~     these outcomes to those observed in Canada, where the dominant therapy has become life-long~     prophylaxis.~   "
179363|NCT01217242|"~     The investigators would like to understand how the physical activity levels and body size of~     a child with cerebral palsy (CP) in a clinical situations versus out in the community relates~     to what they want to do in day to day life (participation in life). The investigators believe~     that what a child really does out in day to day life will predict life participation to a~     greater degree than what they do in a structured clinical situation (i.e. therapy session~     with therapist). The investigators think that increased body size with normal growth is~     related to less physical activity and participation in day to day life for children with~     cerebral palsy (CP) who can walk. This project will use a novel accelerometer to measure~     walking activity during day to day life.~   "
179364|NCT01217229|"~     PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary~     objective of this study is to evaluate the efficacy, as measured by overall response rate, of~     orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin~     lymphoma (HL). Secondary objectives include safety, the duration of response, the disease~     control rate, progression free survival, and how the drug affects your body.~   "
179365|NCT01217216|"~     To test the effectiveness and feasibility of intensive motivational, behavior modifying~     intervention aimed at improving physical activity and dietary habits to produce at least 7%~     weight loss in women with a history of breast cancer in a community health setting.~   "
179366|NCT01217203|"~     The primary objective of the clinical study is to evaluate, in patients who experience a~     first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101~     combined with lenalidomide~   "
179367|NCT01217190|"~     The purpose of this study was to assess the single dose bioequivalence of Ondansetron OSF 8mg~     (Manufactured by MonoSol Rx, USA) with Zofran ODT® (Containing Ondansetron 8 mg)~     (Manufactured by Cardinal Heasth Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo~     SmithKline, Research Triangle Park, NC 27709, Made in England) in healthy, male and female~     adult, human study participants under fasting conditions.~      • To monitor clinical status, adverse events, laboratory investigations and to assess~     relative safety and tolerance of ondansetron formulations under fasting conditions.~   "
179368|NCT01217177|"~     The cervix cancer is the second malignant neoplasia more common between women. The combined~     treatment involving chemotherapy and radiotherapy was defined as the standard. This study~     will evaluate the safety, toxicity and maximal tolerated dose (MTD) of everolimus in~     association with cisplatin and pelvic radiotherapy, in patients with squamous cells carcinoma~     of uterine cervix, in stages IIB and IIIB.~   "
179369|NCT01217164|"~     Adequate nutrition is important for preventing malnutrition in the postnatal period and thus~     optimize growth and development of children born prematurely. To avoid malnutrition is~     recommended to provide nutrients necessary for a growth rate similar to the intrauterine~     life.~      For nearly one decade studying how to minimize in-hospital malnutrition in children born~     prematurely, especially with gestational age less than 32 weeks or with birth weight below~     1,500 g, called newborn very low birth weight (VLBW).~      Embleton et al.demonstrated that with the current nutritional recommendations (protein~     between 3.0 and 3.8 g / kg / day), the VLBW had malnutrition caused by protein and calorie~     cumulative deficit.~      Poor nutrition in the neonatal period can impair growth and neuromotor and cognitive~     development after hospital discharge.~      The investigators hypothesis is that VLBW subjected to aggressive nutrition with~     protein-calorie high from birth until discharge, would present higher weight gain than the~     VLBW infants who received routine diet of service, without producing adverse effects.~   "
179370|NCT01217151|"~     In the last years, there is a growing interest in the improvement of prognosis and shortening~     of hospital length of stay in high-risk surgical patients. Several evidence-based protocols~     (fast-track surgery) have been developed and implemented in some hospitals for this~     purpose. Cardiovascular optimization through the so-called goal-directed therapy (GDT) is a~     key element in these protocols. Previous studies in the literature use invasive monitors to~     assess hemodynamics. The NICOM ™ is a non-invasive monitor validated in several clinical~     scenarios. The aim of the present randomized, international, multi-center, open-label~     clinical trial is to use a GDT protocol (including colloid boluses and vasoactive drug~     infusion) based on data obtained from the NICOM™ device (cardiac index and mean arterial~     pressure) to test the hypothesis that GDT is superior to standard practice in terms of~     reduction in the incidence of perioperative complications and length of hospital stay in~     high-risk major abdominal surgery patients (requiring ICU surveillance for, at least, 24~     hours). As secondary objectives, time to first flatus, wound infection, anastomotic leaks and~     mortality will be analysed. All patients will be followed from the day of surgery up to~     hospital discharge (determined by a specialist surgeon not involved in the study) or death.~   "
179371|NCT01217138|"~     Part of the problems related with proper use of epinephrine autoinjector may be related with~     the design of the autoinjector itself.The aim of the study is to investigate whether minor~     modifications in the design of currently available epinephrine autoinjector ease its use and~     abrogate common use errors.~   "
179372|NCT01217125|"~     The purpose of this study is to determine whether rapamycin is safe and effective in the~     treatment of renal angiomyolipomas in patients with tuberousclerosis.~   "
179376|NCT01217073|"~     The purpose of this study is to assess the hypothesis that treatment with study medication~     (omarigliptin; MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic~     severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5~     different doses of omarigliptin to identify which dose is the most effective in the treatment~     of type 2 diabetes.~   "
179379|NCT01217034|"~     The purpose of this study is to evaluate the safety and efficacy of the combination therapy~     with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in~     patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for surgical~     resection or percutaneous ablation therapy.~   "
179380|NCT01217021|"~     This research will look at how the brain may change in people with Alzheimer disease (AD).~      The purpose of this research is to find out whether changes in the brain in people with~     Alzheimer disease can be detected using a brain imaging test. Most people with Alzheimer~     disease have changes in the brain that result in deposits of a protein called beta-amyloid.~     In this study, the investigators will be using a radioactive drug, [18F]MNI-558 that binds to~     beta-amyloid. This drug is experimental and has not been approved by the FDA. Brain imaging~     using PET (positron emission tomography) will be done to see if the investigators can~     evaluate the areas of beta-amyloid in the subjects with Alzheimer disease. The investigators~     will compare these scans with those done in healthy normal volunteers. PET is a~     brain-scanning test used in medicine and scientific research to see how the brain is working.~     The PET imaging test used in this study is not being done for diagnostic purposes.~   "
179381|NCT01217008|"~     The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single~     time-point between 7 and 14 days post injury, inclusive, to patients with neurologically~     complete spinal cord injuries (SCI).~   "
179382|NCT01216995|"~     Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs~     delivered via the intracoronary route in the treatment of patients with ST-elevation acute~     myocardial infarction (STEMI).~   "
179383|NCT01216982|"~     Stress-related disorders are among the most prevalent and expensive medical consequences of~     participation in military operations. Omega-3 fatty acids EPA/DHA derived from fish oil are~     known to benefit both neuronal development in the young, and cognition and mood in various~     populations.~      It is possible that soldiers receiving Omega-3 EPA/DHA will exhibit significantly higher~     cognitive performance, better affect/mood state, and less combat stress symptomatology~     compared to the placebo after 12 weeks of supplementation. A goal would be to reduce the~     prevalence of combat stress injuries in military personnel.~   "
179384|NCT01216956|"~     Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia.~     Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c)~     but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the~     drug has been used for so long, its precise mechanism of action remains elusive. The aim of~     this study was to characterise the metabolic changes induced by 8 week treatment with Niacin~     in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the~     overall lipid effects of niacin will be studied. In order to get a very comprehensive view of~     all metabolic activities of niacin, this study will investigate the potential effects of~     niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in~     lipoproteins and key enzymes involved in lipid metabolism.~   "
179385|NCT01216943|"~     This study will investigate the safety and efficacy of Triple Combination Therapy~     (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients~     with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on~     brimonidine/timolol ophthalmic solution.~   "
179386|NCT01216930|"~     A clinically applicably strategy for molecular screening for Lynch Syndrome has been~     implemented in the Region of Southern Denmark.~      Based on sequential analysis with immunohistochemistry and methylation analysis, patients~     with possible hereditary colorectal cancer are identified. These patients are offered genetic~     risk assessment and counselling.~      The study hypothesis is that molecular screening will identify more patients with Lynch~     Syndrome than the family history alone.~      Prospective data collection is performed using established clinical databases.~   "
179387|NCT01216917|"~     The purpose of the present study is to evaluate the influence of the ageing process on muscle~     quality. Therefore, muscle mass, muscle density and force-velocity characteristics are~     measured after a 5-yr interval in older adults (65+).~   "
179388|NCT01216904|"~     The specific aims of this study are to examine whether treatment with transdermal nicotine~     improves computer-based laboratory and clinical measures of impulsive and compulsive~     behaviors in Parkinson's Disease subjects who have recently experienced an impulse control~     disorder.~   "
179389|NCT01216891|"~     This study will assess the effectiveness of an experimental treatment intervention for~     adolescents and adults who have experienced their first episode of psychosis during the past~     two years.~      The DUP sub-study will collect pathways to care information that will be used to inform the~     development and pilot testing of strategies that aim to reduce DUP among individuals~     experiencing a first episode of psychosis.~   "
179390|NCT01216878|"~     The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet~     under fasted conditions.~   "
179391|NCT01216865|"~     The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of~     treatment for diabetic foot is safe and effective in the management of diabetic foot~     ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in~     ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and~     relieve the Sevier pain of ischemia.~   "
179392|NCT01216852|"~     The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet~     under fasted conditions.~   "
179393|NCT01216839|"~     The purpose of this study is to determine the Everolimus aim response in children and~     adolescents with refractory or relapsed Rhabdomyosarcoma and other soft tissue sarcomas~   "
179394|NCT01216826|"~     The purpose of this study is to determine the Everolimus aim response in children and~     adolescents with refractory or relapsed osteosarcoma.~      The aim response is defined as complete or partial response (according to RECIST criteria)~     for at least 4 weeks, or stable disease for at least 12 weeks.~   "
179395|NCT01216813|"~     RATIONALE: Gathering information from patients who have undergone treatment for upper~     gastrointestinal cancer or gynecological cancer may help doctors learn more about patients'~     physical and psychosocial rehabilitation needs and plan the best treatment.~      PURPOSE: This clinical trial is studying the physical and psychosocial rehabilitation needs~     of patients after diagnosis and treatment of upper gastrointestinal cancer or gynecological~     cancer.~   "
179396|NCT01216800|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery~     may kill any tumor cells that remain after surgery. It is not yet known whether~     intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy is more~     effective in decreasing hearing loss in patients undergoing radiation therapy for parotid~     gland cancer.~      PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to~     see how well it works compared with 3-dimensional conformal radiation therapy in decreasing~     hearing loss in patients who have undergone surgery for parotid tumors.~   "
179397|NCT01216787|"~     This pilot phase II trial is studying how well RO4929097 works in treating patients with~     stage III, or stage IV melanoma that can be removed by surgery. RO4929097 may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth~   "
179398|NCT01216774|"~     The purpose of this study is to compare the impact of different levels of mechanical stress~     and muscle fatigue in strength training conditions on muscle strength, muscle mass and~     inflammatory processes.~   "
179399|NCT01216761|"~     Background: Contaminated blood cultures result in unnecessary antibiotic use, increased~     length of stay, and additional laboratory tests, all of which increase healthcare costs.~     While the optimal skin antisepsis agent for reducing blood culture contamination is not~     known, the cost of various agents differs substantially.~      Objective: To determine the relative rates of blood culture contamination for 3 skin~     antisepsis interventions - 10% povidone iodine aqueous solution (PI), 2% iodine tincture (IT)~     and 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG) - when used by dedicated~     phlebotomy teams to obtain peripheral blood cultures in adult non-ICU medical and surgical~     patients.~   "
179400|NCT01216748|"~     The purpose of this study was to determine if airway pH has an effect on albuterol-induced~     vasodilation in the airway. Methods: Ten healthy volunteers performed the following~     respiratory maneuvers: quiet breathing, hypocapnic hyperventilation, hypercapnic~     hyperventilation, and eucapnic hyperventilation~   "
179401|NCT01216735|"~     The hypothesis underlying the proposed study is that the blunted endothelium-dependent~     vasodilation seen in the airway of current smokers is also present in the brachial artery,~     and that the same inhaled corticosteroid (ICS) treatment regime that reversed endothelial~     function in the airway of current smokers will also restore endothelium-dependent relaxation~     in the brachial artery. Non-smokers will be used as controls and will not receive any~     intervention or treatment.~   "
179402|NCT01216722|"~     Resistance strengthening exercise will increase strength and functional activity greater than~     ambulation in subjects post-liver transplantation.~   "
179403|NCT01216709|"~     Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with~     cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant~     foods are recommended for infants. However, the optimal iron dose and mode of delivery have~     not yet been established. This is a concern as excessive iron intake may impair growth and~     increase morbidity in iron-sufficient infants. Previous studies have suggested that~     iron-fortified foods may have different effects than iron supplements. In this study, the~     investigators will investigate whether the mode of iron administration (supplementation vs.~     fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption,~     iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.~   "
179404|NCT01216696|"~     This is an Open-label, single-arm, phase II study of ipilimumab in patients with spontaneous~     preexisting immune response to NY-ESO-1.~      Preclinical data suggest, that CTLA-4 blockade enhances polyfunctional T cell responses in~     patients with melanoma. Thus patients with immunological response to NY-ESO-1 might benefit~     from an anti CTLA-4 treatment.~      Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction~     period, followed by a radiological assessment in week 12. Patients with clinical benefit~     (partial response, complete response or stable disease according to the immune-related~     response criteria) will continue with an ipilimumab administration every 3 months starting at~     week 24 up to week 48 until the end of the study or until disease progression,toxicities~     requiring discontinuation~   "
179405|NCT01216683|"~     RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies,~     such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells~     from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab~     together alone is more effective than giving bendamustine hydrochloride and rituximab~     together with bortezomib or lenalidomide in treating follicular lymphoma.~      PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and~     rituximab together with or without bortezomib followed by rituximab with or without~     lenalidomide to see how well they work in treating patients with high-risk stage II, stage~     III, or stage IV follicular lymphoma.~   "
179406|NCT01216670|"~     The CARRYING ON for heart failure (HF) study is a national, prospective, post market~     interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a~     short term and a long term period, incidence of pre-specified clinical and arrhythmic events~     in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac~     decompensation.~   "
179407|NCT01216657|"~     Sunitinib is a novel small molecule receptor tyrosine kinase inhibitor with direct antitumor~     effects as well as antiangiogenetic activity. Preclinical and clinical data for Sunitinib and~     data about angiogenesis and growth regulation in melanoma suggest the activity of Sunitinib~     in melanoma. This study will investigate the efficacy, safety and tolerability of Sunitinib~     as palliative treatment in chemo-refractory metastatic melanoma.~   "
179433|NCT01216319|"~     Patients with a desire for nipple reconstruction following breast cancer and breast~     reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing~     the COOK Biodesign® Nipple Reconstruction Cylinder.~   "
179434|NCT01216306|"~     Obesity has been linked to the development of multiple cancers, and to poorer prognoses and~     higher mortality rates for certain pediatric and adult cancers. Preventing obesity is~     therefore a major strategy to prevent new cases of cancer and to decrease cancer related~     morbidity and mortality. In the US, childhood obesity is on the rise. Since childhood obesity~     strongly tracks into adulthood this epidemic among children greatly increases the risk of~     obesity and presumably cancer in adulthood. As a result, preventing childhood obesity has~     been selected as a major public health goal to reduce the risk and sequelae of obesity and~     cancer in the US.~      Moreover, television (TV) viewing has been identified as a major risk factor for childhood~     obesity and US children spent more time watching TV than any other activity except sleep. TV~     viewing contributes to excess weight gain by decreasing physical activity and increasing~     caloric intake. The American Academy of Pediatrics (AAP) has issued national guidelines for~     parents to limit their children's total entertainment media time to no more than 1 to 2 hours~     of quality programming per day for children greater than 2 years of age. Low-income and~     minority children were at greater risk for exceeding this recommendation.~      Few published interventions have been successful in decreasing TV viewing in children and~     only one was successful among preschool children. This intervention, Fit 5 Kids (i.e. fit~     by age 5 years), was a preschool curriculum designed to decrease TV viewing via~     age-appropriate lessons taught to the children by research staff. The curriculum also~     included a take-home component consisting of a newsletter with ideas for parent (for this~     grant, defined as the adult most responsible for the child's care, usually the mother) and~     child activities that complemented the school lesson plans. Although most behavioral~     interventions for preschoolers target parents rather than children, this curriculum was one~     of the few successful interventions targeted directly at children. However, Fit 5 Kids was~     not designed for or evaluated among Hispanic preschool children, the subpopulation of~     preschool children most severely affected by obesity. Moreover, no published intervention has~     successfully reduced both TV viewing and excess weight gain in any preschool population. In~     order to fill this gap, the investigators propose to evaluate a culturally adapted Fit 5 Kids~     TV reduction curriculum among Hispanic preschool children enrolled in the Head Start Program.~      Fit 5 Kids is the TV reduction component of the Brocodile the Crocodile health promotion~     program. The overall goal of Fit 5 Kids is to teach the preschoolers to decrease their TV~     watching and encourage alternative activities such as family meals and active playtime. The~     primary goal of this research plan will be to conduct a pilot group randomized controlled~     trial evaluating the effectiveness of the adapted curriculum to reduce TV viewing and excess~     weight gain in low income, Hispanic preschool children~      To achieve the project goals, the investigators Specific Aim includes:~      1. To successfully recruit forty-eight 3-5 year old Hispanic children from 4 Head Start~     centers each year for 3 years and conduct a group randomized controlled study of the adapted~     Fit 5 Kids curriculum to evaluate its effectiveness in reducing TV viewing and excess weight~     gain in Hispanic preschool children.~      The Primary Hypothesis to be tested includes:~      H1. The culturally adapted Fit 5 Kids curriculum will reduce TV viewing and excess weight~     gain among Hispanic preschool children.~   "
179408|NCT01216644|"~     Patients with locally advanced resectable adenocarcinoma of the stomach or the~     esophagogastreal junction without previous therapy will be treated with one of two~     chemotherapy combinations before and after surgery. One half of the patients gets~     5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Epirubicin,~     Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.~   "
179409|NCT01216631|"~     The aim of this study is to establish the efficacy and duration of effect of intra-articular~     (IA) infliximab vs intravenous infliximab vs current standard care (IA steroid injections) in~     seronegative oligoarthritis. All patients will have seronegative arthritis affecting less~     than 5 joints but including at least one knee. 10 patients will receive IA infliximab~     injections to the affected knee, 10 will receive IA steroid injections to the affected knee~     and 10 will receive a course of intravenous infliximab. Patients will not be aware of their~     group as this is a placebo-controlled study.~   "
179410|NCT01216618|"~     The study is a prospective, multi-center, open label, randomized; two-arms cross over study.~      This is the test protocol for the InsuPatch device, whose purpose is to improve insulin~     delivery into the blood when the insulin is infused using an insulin-infusion pump by~     controlled heating of the area surrounding the point of infusion.~   "
179411|NCT01216605|"~     The present study was designed to investigate the effects of a single dose of synthetic~     oxytocin on facial emotion recognition in healthy adult man. Pictures of emotional faces are~     presented very briefly for a few milliseconds in a backward-masking paradigm in order to vary~     the level of awareness. In a randomized placebo-controlled between-subject design,~     recognition performance is compared between a drug (24 IU oxytocin) and a placebo condition.~     We hypothesize that oxytocin enhances emotion recognition even for facial stimuli processed~     with limited awareness.~   "
179412|NCT01216592|"~     Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high~     prevalence worldwide and with relevant impact on patient-related quality of life, morbidity~     and mortality. There is evidence that airway inflammation correlates with the severity of the~     disease and that airway inflammation is further enhanced during exacerbation. However, it is~     unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by~     changes in airway inflammation.~   "
179413|NCT01216579|"~     The investigators hypothesise that titration of asthma medication against mannitol challenge~     results will reduce the number of mild asthma exacerbations, in one year, when compared with~     titration against BTS guidelines. To test this hypothesis the investigators propose a primary~     care, parallel treatment, patient blinded study in which matched groups of asthmatic patients~     will be treated in accordance either with BTS guidelines or with our treatment algorithm~     dependent on mannitol challenge result.~      Purpose of the study is to evaluate the efficacy of a treatment algorithm based on the~     measurement of airway hyperresponsiveness to mannitol challenge, a surrogate marker of airway~     inflammation, in the long term treatment of asthma in comparison to BTS guidelines.~   "
179414|NCT01216566|"~     The purpose of this study is to investigate the efficacy and safety of the Occiflex device in~     the treatment of neck pain.~   "
179415|NCT01216553|"~     The aim of the study was to investigate the utility and safety of home management of home~     oxygen therapy in acute bronchiolitis. A matched case-control study, of one hundred and~     thirty five infants aged less than 12 months diagnosed bronchiolitis with hypoxia attending a~     pediatric community clinic will be randomly assigned to receive oxygen with or without~     standard nebulized therapy. Nebulized treatment with either 0.1% epinephrine diluted in~     bromhexine, or 3% hypertonic saline. Intermittent oxygen treatment will be administered 6~     times daily for 7 days. Primary outcome measures will be emergency department~     visits/hospitalization secondary outcome measures will be changes in Bronchiolitis Caregiver~     Diary Score.~   "
179416|NCT01216540|"~     The primary goal of this study is to determine if there is an association between greater~     exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to~     estimate the costs to the hospital associated with these nephrotoxic events.~   "
179417|NCT01216527|"~     The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery versus~     surgery, in terms of the overall survival time (OS) in patients with Stage IIB or III~     squamous cell esophageal carcinoma.~   "
179418|NCT01216514|"~     Factors forecast Chronic Inflammatory Bowel Diseases (IBD) remain at present essentially on~     clinical factors (extension of the disease, achievement of the perianal ring, requirement of~     surgery, treatment by immunomodulators…). All IBD specific immunological or serological~     markers showed only a diagnostic role for indefinite colitis (hemorrhagic Rectocolitis vs~     Crohn Disease) but were never able to be considered as predictive elements of adults IBD~     evolution. Among the most used, the presence of ANCA's antibody and ASCA allows to separate~     hemorrhagic rectocolitis (ANCA + / ASCA-) from Crohn disease (ANCA-/ASCA +) and their~     combination present an average sensibility about 85 % and a 85 % specificity. However, 8~     other antibody types were recently isolated and estimated individually during IBD in~     particular during child Crohn diseases (anti-OmpC, anti-I2, anti-CBir1, anti-glycans (ALCA,~     AMCA and ACCA) anti-Goblet cells and albicans Candida's specific anti-mannan). These~     complementary assays improve significantly the reliability of the diagnosis. However, if the~     use of these new markers has an indisputable diagnostic role, their predictive role in the~     evolution of IBD was estimated at the adult's only rarely during Crohn diseases.~     Consequently, the investigators suggest realizing an exhaustive analysis of all these new~     immunological markers to define, if their association can have an interest in the~     differentiation of stable (or little evolutionary) and unstable (or quickly evolutionary)~     clinical forms.~   "
179430|NCT01216358|"~     The objectives of this prospective, descriptive study are to:~        1. generate estimates of the incidence, prevalence, persistence, clinical impact and~          attributable risk of migraine due to hormonal contraception (HC) use; and~        2. identify predictive factors for clinically significant changes in headache attributable~          to HC use.~      The investigators hypothesize that:~        1. Most women with pre-existing migraine will have no significant change from baseline~          headache frequency or clinical impact attributable to HC at 3 months following~          initiation; a minority will report clinically significant worsening or improvement~        2. The incidence of headache and migraine in HC users will not be significantly different~          from their incidence in NHC users~        3. There will be identifiable risk factors for development or worsening of~          headache/migraine in the minority of HC users where that occurs.~   "
179419|NCT01216501|"~     In children, radiofrequency catheter ablation (RFCA) or cryoablation are highly effective~     treatments for supraventricular tachycardia treatment. General anesthesia is often required~     to ensure comfort during the prolonged procedure and to assure immobility in order to~     facilitate accurate mapping and subsequent ablation of the accessory pathway and/or~     arrhythmogenic focus. Successful anesthetic management of this patient population requires~     adequate suppression of sympathetic responses during the procedure while electrophysiological~     parameters remain unaltered for mapping purposes and subsequent ablation. Although~     Sevoflurane (SEVO) and Isoflurane (ISO) are two commonly used and evaluated volatile~     anesthetic agents for ablation procedures, comparison of those agents has not been performed~     previously not in adults, not in children.~      Hypothesis Time required for basic EP intervals, successful induction of SVT and successful~     RFCA or cryoablation in children will not be different between patients undergoing~     Sevoflurane or Isoflurane-based anesthesia.~   "
179420|NCT01216488|"~     Hospitalized patients for superior member surgery have different types of anesthesia.Forearm~     and/or arm surgery could be done under general anesthesia, but in the most of the cases, this~     surgery was done under locoregional anesthesia.Several injections of local anesthesia at the~     nerves axilla are used with the used of ultrasonography.~      The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25~     ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.~   "
179421|NCT01216475|"~     Background: Small Incision Lenticule Extraction or SMILE is a novel form of 'flapless'~     corneal refractive surgery that was adapted from Refractive Lenticule Extraction (ReLEx).~     SMILE uses only one femtosecond laser to complete the refractive surgery, potentially~     reducing surgical time, side effects and cost. If successful, SMILE could potentially replace~     the current, widely practiced Laser In-situ Keratomileusis or LASIK. The aim of this study is~     to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at~     3-months post-operatively.~      Methods/ Design: Single tertiary center, parallel group, single-blinded, paired-eye design,~     non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be~     enrolled for study after informed consent. Each participant will be randomized to receive~     SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority~     trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00D)~     at a tertiary eye center in terms of refractive predictability at 3 months post-operatively.~     Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE~     differs from LASIK in adults (>21 years old) with myopia (> -3.00D) at a tertiary eye center~     in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3~     months post-operatively. Our primary outcome is refractive predictability, which is one of~     several standard refractive outcomes, defined as the proportion of eyes achieving a~     postoperative spherical equivalent (SE) within ±0.50 diopter (D) of the intended target.~     Randomization will be performed using random allocation sequence generated by a computer with~     no blocks or restrictions, and implemented by concealing the number-coded surgery within~     sealed envelopes until just before the procedure. In this single-blinded trial, subjects and~     their caregivers will be blinded to the assigned treatment in each eye.~      Discussion: This novel trial will provide information on whether SMILE has comparable, if not~     superior, refractive outcomes compared to the established LASIK for myopia, thus providing~     evidence for translation into clinical practice.~   "
179422|NCT01216462|"~     The NET-SCA Registry has been designed to document and evaluate the clinical epidemiology and~     current management of Acute Coronary Syndromes in the Lazio Region of Italy.~   "
179423|NCT01216449|"~     Antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs) are most~     commonly prescribed to treat depression and anxiety. How antidepressants work on the brain to~     alter mood and behaviour is not well understood. This study will use a brain scanning~     technique (functional magnetic resonance imaging) to examine how aging impacts brain~     activation during emotional tasks after the administration of intravenous (IV) citalopram~     (this is the only SSRI available in this form, and is well tolerated and safe in young and~     old adults). The investigators will further determine what role genetic differences play in~     this relationship. The investigators expect to see an increase in brain signal as the~     concentration of IV citalopram increases. However, the investigators propose that the brain~     signal in older adults will not be as strong as in younger adults. Furthermore, the~     investigators expect that participants genetically predisposed to have fewer serotonin~     transporters (the site of action of SSRIs) will show greater decreases in brain activation~     with citalopram.~   "
179424|NCT01216436|"~     Our proposed study is designed to test the safety of a new vaccine against melanoma. The~     induction of immune activity against cancers such as melanoma is a promising approach to~     cancer treatment, but to date, only a few clinically significant immune responses have been~     seen following vaccine therapy. This is an important problem, since there are very limited~     treatment options for patients with metastatic melanoma (melanoma that has spread to lymph~     nodes and organs).~      Studies suggest that monoclonal antibodies (mAbs) that block inhibitory receptors on immune~     cells can enhance the immune responses against cancer, but the intravenous injection of such~     mAbs has caused severe side effects in animals and humans. In our laboratory, we have~     developed a method to deliver mAbs and other proteins that block such inhibitory receptors~     locally at the site where immune responses against melanoma proteins are stimulated by~     vaccination, enhancing anti-melanoma immunity while avoiding the side-effects associated with~     intravenous injection of these immune modulators. This is achieved by loading dendritic~     cells, a type of immune cell, with RNA that encodes the immune modulator. The RNA-loaded~     dendritic cells then make the immune modulatory proteins and release them locally. By mixing~     these dendritic cells with additional dendritic cells loaded with melanoma proteins, the~     immune modulators are released at the site where anti-melanoma immune cells are stimulated.~      In this phase I trial, subjects with metastatic melanoma will undergo the process of~     leukapheresis, in which white blood cells are removed from the body. Monocytes, a type of~     immune cell, will then be purified from the white blood cells and cultured under conditions~     that will change them into dendritic cells. Half of these dendritic cells are then loaded~     with melanoma antigen RNA, which will lead to the production of melanoma antigen proteins~     within the dendritic cells. The remaining half of the dendritic cells will be either~     untreated or loaded with RNA encoding immune modulators so that these dendritic cells will~     release immune modulators at the site of vaccination. These dendritic cells will be mixed~     with the melanoma antigen-loaded dendritic cells and injected as a vaccine into lymph nodes.~     Each subject will receive six weekly injections of their own dendritic cells. Safety and~     toxicity will be closely monitored. In addition, immune responses against melanoma, as well~     as clinical responses, will be assessed.~   "
179425|NCT01216423|"~     The cause of ischemic stroke remains frequently unknown. In patients with patent foramen~     ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that~     the main mechanism is paradoxical embolism and decided to look for clinically apparent and~     silent cerebral embolism in patients with a recent pulmonary embolism.~   "
179426|NCT01216410|"~     The study investigates the incidence of intraoperative nausea and vomiting under spinal~     anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.~   "
179427|NCT01216397|"~     The objective of the current study is to investigate the relative bioavailability of two~     different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet~     (FDC).~   "
179428|NCT01216384|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and~     healthy Japanese male volunteers following single oral administration and multiple~     administrations.~   "
179429|NCT01216371|"~     The aim ist to identify biomarkers in the blood, to indicate early response or early~     treatment resistance.~   "
179431|NCT01216345|"~     The aim of this prospective single-centre phase II study is to investigate the therapeutic~     efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in~     the palliative first line treatment of biliary tract cancer (BTC) patients.~   "
179436|NCT01216280|"~     This study is to evaluate the efficacy and tolerability of multiple oral doses of~     Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a~     randomized, double-blind, placebo-controlled, parallel-design study. Up to 75 patients will~     complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical~     sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo,~     Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending~     Sponsor approval, if it appears that less than 60 patients will complete the study.~   "
179437|NCT01216267|"~     The goal of this study is to compare several methods for measurement of Chromogranin A in~     their ability to serve as a marker for disease activity in patients with neuroendocrine~     tumors.~      Further, in a subgroup, we will determine if taking a proton pump inhibitor affects~     Chromogranin A levels.~   "
179438|NCT01216254|"~     The aim of this study is to assess the outcomes of breast conserving therapy operation~     depending on the type of surgical tool used: classic electrocoagulation with higher operative~     temperatures and high frequency electrocoagulation with lower operative temperatures. The~     investigators would assess the pain levels, length and amount of the lymphatic secretion as~     well as quality of life following breast conserving surgery.~   "
179439|NCT01216241|"~     The purpose of this study is to evaluate the benefits and side effects of daptomycin compared~     to placebo for the treatment of neutropenic fever.~   "
179440|NCT01216228|"~     Health outcome studies should examine food patterns, because foods are consumed together and~     nutrients are metabolized jointly. To examine associations between food patterns and markers~     of systemic and vascular inflammation at baseline, in a population-based cohort in Malmö,~     Sweden, and after 13 years of follow-up food pattern associations with CVD incidence.~   "
179441|NCT01216215|"~     Research Problem Asthma is one of the most common chronic diseases in the world that affects~     approximately 300 million individuals worldwide. It is characterized by airway inflammation~     and bronchoconstriction leading to airflow obstruction, however, the triggering factors~     behind asthma development remains to be elucidated. Genetic risk factors have been suggested~     to play a central role in asthma development. Twin studies supported a strong genetic~     component to asthma, especially childhood asthma, with heritability estimates suggesting that~     48-70% of asthma risk is attributed to genetic risk factors. Suggestive susceptibility genes~     have been identified in European and American populations but not yet in the Middle East~     including Saudi Arabia. Identified genes whether they are polymorphic variants of genes~     encoding known pathophysiological molecules or novel genes identified by linkage or~     genome-wide association studies (GWAS) are inconsistent in different populations thereby~     adding to the need to undertake genetic studies on different ethnic populations and in~     different countries. Here, the investigators hypothesize that polymorphic variation of novel~     susceptibility genes form a major risk factor for asthma development, response to treatment~     and progression in the Saudi population with strong diagnostic, prognostic and therapeutic~     implications.~      Research Significance Since the manifestation of complex inflammatory disorders with strong~     heritability is complex involving genetic and environmental interaction, each ethnically~     distinct population must be examined to know whether gene-disease association exists in that~     population. The objectives of this proposal are to discover novel asthma susceptibility genes~     in the Saudi population. A better understanding of the genetic mechanisms of asthma will~     enhance our knowledge of its pathophysiology. Asthmatic patients with distinct genotypes~     respond differently to asthma medications. Therefore, improvements in diagnostics and~     pharmacogenetics may be the first clinical developments of these extensive studies. This~     embraces the concept of asthma subphenotypes and stratified medicine where interventions are~     targeted at those individuals who will best benefit from them with minimal side effects.~     Physicians looking after asthmatic patients will be able to provide better medical service~     tailored to those patients, as well as to identify Saudi people at high risk for the~     development of asthma, especially the more severe forms of the disease.~      Research Objectives The main objective of our proposal is to identify known and novel asthma~     susceptibility genes in the Saudi population and to investigate their interaction with~     clinical, environmental, and inflammatory factors contributing to asthma pathophysiology.~      Research Methodology In this proposal, the investigators will investigate the genetic factors~     contributing to asthma susceptibility by determining in Saudi population, the presence of~     single nucleotide polymorphisms (SNPs) that have been previously reported from linkage and~     GWAS in other populations. Whole genome DNA will also be scanned for novel SNPs of selected~     asthma genes using microarrays. This will enable us to identify new SNPs that contribute to~     the risk of asthma specifically in the Saudi population. In addition, the investigators will~     cross-reference all genetic and immunological parameters with the corresponding clinical data~     in order to elucidate the impact of certain genes, or their products (e.g. cytokines), on the~     clinical manifestation of asthma.~   "
179442|NCT01216202|"~     Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal~     cancer. For men there are theoretical reasons to believe that the treatment may effect~     hormone levels, spermatogenesis, sexual function and wellbeing. To address these questions a~     longitudinal observational study was initiated where patients can choose to take part in one,~     two or three parts of the study. The three different parts are blood tests, questionnaires~     and semen samples.~   "
179443|NCT01216189|"~     Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal~     cancer.For women there are theoretical reasons to believe that the treatment may affect~     hormone levels, sexual function and wellbeing. To address these questions a longitudinal~     observational study was initiated where patients, before preoperative radiotherapy and one~     year after surgery, take blood tests and answer two questionnaires.~   "
179444|NCT01216176|"~     The investigators propose to conduct a Phase I/randomized Phase II study design in order to~     test the tolerability and efficacy of AZD0530 when used together with anastrozole in therapy~     for ER+ and/or PR+, postmenopausal breast cancer. The Phase I pharmacokinetic (PK) cohort of~     the study (cohort A) in postmenopausal women with metastatic breast cancer 2008-2009 showed~     initial safety,tolerability and good bioavailability of both drugs and determined the doses~     for use in the ongoing Phase II trial. In the randomized Phase II cohort of the study (cohort~     B), postmenopausal women with newly diagnosed, previously untreated ER+, HER2 negative breast~     cancer that is at least 2 cm or more in diameter by clinical exam or radiology will be~     randomized to either neoadjuvant treatment with anastrozole plus placebo, or anastrozole in~     combination with AZD0530. The Phase II cohort will permit extended assays of tolerability,~     initial estimates of efficacy, and the investigation of molecular predictors of drug~     efficacy.~   "
179445|NCT01216163|"~     This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen~     formulation to placebo and acetaminophen in the treatment of post-surgical dental pain~     following wisdom tooth (third molar) removal.~   "
179446|NCT01216150|"~     Aims Aspirin combined with clopidogrel is the treatment of choice for acute coronary~     syndromes. Although the maintenance of aspirin until surgery does not affect postoperative~     bleeding after coronary artery bypass graft (CABG) surgery, the latter may be dramatically~     increased when clopidogrel is continued over a period of 5 days preoperatively. Methods and~     results: This prospective observational study will include 136 consecutive patients scheduled~     for first-time CABG. Postoperative bleeding and blood transfusion requirements will be~     compared (non inferiority)between patients pretreated during a period of 5 days prior surgery~     by either aspirin alone or combined with clopidogrel. Tranexamic acid will be systematically~     used in all these patients considered as high risk for bleeding.~      In concusion, this study has to to test the hypothesis that with tranexamic acid also,~     bleeding in the aspirin + clopidogrel group is not 25% more important than in the aspirin~     alone group after CABG surgery, according to the previous study using aprotinin.~   "
179447|NCT01216137|"~     The purpose of this study was to test the feasibility and effectiveness of a novel exercise~     intervention for individuals who live with multiple sclerosis (MS).~   "
179448|NCT01216124|"~     The 10%-15% of breast carcinomas known to be 'triple negative (TN)' (not expressing HRs and~     not exhibiting overexpression Her2) constitutes 85% of all basal-like tumors, because it is~     based on three standard immunohistochemical biomarkers.~      In clinical routine, Docetaxel was widely indicated as first-line therapy for breast cancer~     patients in adjuvant or neoadjuvant settings. Oxaliplatin,~     trans-1-diaminocyclohexane-platinum, may offer advantages over other platinum agents.~     Oxaliplatin promotes formation of DNA adducts, preventing DNA replication and transcription~     and ultimately causing apoptosis. Oxaliplatin was more potent than cisplatin and the~     Oxaliplatin-based regimen was active for the patients of lung cancer, colorectal cancer and~     ect. TNBC patients were more sensitive to platinum-based chemotherapy regimens according to~     the results of some retrospective studies. There was no report about Oxaliplatin in the~     chemotherapy setting for breast cancer patients.~      The investigators hypothesized that using Oxaliplatin adding to docetaxel would be feasible~     and active in patients with TNLABC because in vitro findings suggest synergism between the~     agents. This study was designed to investigate the efficacy and toxicity of oxaliplatin-based~     regimen as a neoadjuvant chemotherapy setting in triple negative local advanced breast cancer~     patients~   "
179515|NCT01215253|"~     The purpose of the study is to see how effective a drug called ranolazine is in reducing the~     risk of ventricular arrhythmia and death in people with implantable~     cardioverter-defibrillators (ICDs). This drug will be used with standard medications that is~     routinely prescribed in enrolled patients.~   "
179449|NCT01216111|"~     Previous studies in Western country show that triple-negative breast cancer has aggressive~     clinical and pathological features compared with non-triple negative breast cancer, including~     onset at a young age, advanced clinical stage, high histologic and nuclear grade and more~     distant recurrence.~      According to the characteristics of triple negative breast tumor, the TNBC patients can~     benefit neither from hormonal therapies nor from target therapies against Her2 receptors. The~     only systemic therapy currently available is chemotherapy, and prognosis remains poor. It~     becomes more and more important to investigate the sensitive chemotherapy regimen for triple~     negative patients.~      Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and~     ect. Triple negative breast cancer patients were more sensitive to platinum-based~     chemotherapy regimens according to the results of some retrospective studies.~      The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to~     triple negative breast cancer compared with CEF followed by docetaxel.~   "
179450|NCT01216098|"~     The purpose of this study is to evaluate the impact of doula support on childbirth outcomes~     of women who are eligible for and attempting to have a Vaginal Birth After Cesarean (VBAC).~     Doulas are paraprofessionals who provide women with continuous physical and emotional support~     throughout the course of labour. They also conduct home visits in the prenatal and postpartum~     periods in order to provide women with information on childbirth-related topics and~     breastfeeding support. They do not perform clinical tasks. Their value lies in the~     psycho-social care that they provide. It is hypothesized that women who receive doula support~     alongside standard care will have a lower rate of epidural analgesia use and greater cervical~     dilation at time of epidural administration, as compared to those who receive standard care~     alone.~   "
179451|NCT01216085|"~     This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of~     high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60~     months after Glivec administration will be described.~   "
179452|NCT01216072|"~     The purpose of this study is to evaluate the change in patient-reported outcomes, physician~     assessment of a change as well as safety and tolerability in patients with Relapsing Forms of~     Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of~     two treatment arms: fingolimod vs. standard of care DMT.~   "
179453|NCT01216059|"~     Atopic dermatitis is a common problem faced by patients of all ages and backgrounds.~     Treatment regimens and specific therapies may be time consuming and multiple studies have~     documented a parallel decrease in compliance as time after an office visit increases. The~     adolescent population is an extremely challenging sub-group of patients in terms of complying~     with a treatment regimen. Not only are they striving for independence and thus lacking~     supervision of a regimen by a parent, but their complex thinking skills are immature, leading~     to forgetful behavior. By introducing a reminder system for these vulnerable patients that is~     easily incorporated into their daily lives, the investigators propose that patients will have~     better compliance at applying their medication and thus improving their atopic dermatitis.~     Text-messaging via cell phones has become very popular among teenagers and adults and~     provides a non-obtrusive method of sending a treatment reminder.~   "
179454|NCT01216046|"~     The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770~     alone and in combination in healthy subjects.~   "
179455|NCT01216033|"~     The aim is to study if breast cancer metastases accumulate the newly developed HER2 binding~     molecule 111-In-ABY025 and if that shows whether the metastases express HER2.~   "
179456|NCT01216020|"~     BACKGROUND:~      Concomitant radiotherapy and cisplatin (CDDP) based chemotherapy is the standard treatment~     for LA-NHSCC. This combined modality treatment is linked with considerable acute local and~     systemic toxicity.EGFR is overexpressed in 90-100% of the HNSCC cases and is considered an~     unfavourable prognostic marker. EGFR costitutive activation is linked with HNSCC~     pathogenesis.~      Cetuximab is a monoclonal anti-EGFR antibody blocking the activation of the receptor and~     signal transduction. Cetuximab combined with radiotherapy is superior to radiotherapy only in~     the treatment of LA-HNSCC and is characterized by an acceptable toxicity profile.~      RATIONALE:~      A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant~     treatment with radiotherapy associated to cetuximab does not exist.~      STUDY DESIGN:~      Arm A: Radical radiotherapy (doses and volumes) concomitant with chemotherapy with Cisplatin~     (40 mg/mq/week) Arm B: Radical radiotherapy (doses and volumes) concomitant with therapy with~     the monoclonal antibody Cetuximab (400 mg/m2 [loading dose] and subsequently 250 mg~     /m2/week)~   "
179457|NCT01216007|"~     The objective of this pilot study is to compare plasma [bupivacaine] between two groups of~     paediatric patients under general anaesthesia who will all receive regional caudal~     anaesthesia with bupivacaine: group 1 will receive TIVA and group 2 will receive a volatile~     anaesthetic.~   "
179458|NCT01215994|"~     The purpose of the present study is to evaluate bias, precision and accuracy of new cystatin~     C and creatinine based equations for GFR estimation compared with 51Cr-EDTA (chromium-51~     labeled ethylenediamine tetraacetic acid) measured GFR in patients with diabetes.~   "
179459|NCT01215981|"~     Study Design:~      This is a randomized, single center study to evaluate immune responses to the seasonal~     influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who~     receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy~     adult volunteers will be recruited as controls to confirm immune response to a single~     influenza vaccine.~   "
179460|NCT01215968|"~     The primary purpose of this Study is to help answer the following research question(s).~        -  How does LY2189265 affect gastric emptying (the speed at which food and drink leaves the~          stomach) in patients with Type 2 diabetes?~        -  How does LY2189265 affect how the body handles metformin (a drug used to treat Type 2~          diabetes)?~        -  Is LY2189265 safe and are any side effects associated with it?~      The study will be participant-blind in Week 1, and participant- and investigator-blind from~     Week 2 through Week 5.~      Each participant will receive placebo on Week 1 and once-weekly doses of LY2189265 or Placebo~     on Weeks 2 to 5. Participants taking metformin for the treatment of Type 2 Diabetes Mellitus~     (T2DM) will continue taking metformin as part of the study.~   "
179555|NCT01214720|"~     This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to~     a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated~     time of study treatment is until confirmed evidence of disease progression, and the target~     sample size is 500+ individuals.~   "
179461|NCT01215955|"~     Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature.~     The purpose of this study is to evaluate the efficacy and safety of two approaches to~     escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving~     adequate glycemic control on basal insulin.~   "
179462|NCT01215942|"~     The primary purpose of this study is to help answer if LY2127399 is safe and effective during~     long-term treatment in patients with Rheumatoid Arthritis.~      This study is comprised of 2 periods:~      Period 1 - unblinded treatment for up to 240 weeks for patients who enroll from Study~     H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks~     for patients who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).~      Period 2 - 48 week post treatment follow up~   "
179463|NCT01215929|"~     Methamphetamine use is very common in the US and is associated with serious medical and~     psychiatric problems. There has also been a significant increase in the number of patients~     entering treatment for methamphetamine dependence, however, no pharmacologic treatment has~     been identified as effective in treating methamphetamine addiction. Given that withdrawal~     from methamphetamine is thought to contribute to relapse to methamphetamine use during early~     treatment, it is important to examine potential pharmacologic agents for alleviating~     withdrawal. Thus, this study is designed to study methamphetamine withdrawal in humans. To~     this end, 30 methamphetamine dependent participants (ages 18-65 years) will be entered into a~     4-week residential study. Urine samples will be obtained at baseline to ensure recent~     methamphetamine use. Intake assessments will include cognitive testing, standardized~     assessment of depression and anxiety, profile of mood states, methamphetamine selective~     severity assessment, methamphetamine withdrawal assessment, sleep quality and quantity, a~     pre-attentional measure and attentional measure. Upon admission to the residential facility,~     all study participants will be started on (20-30mg) long acting amphetamine/d-amphetamine and~     stabilized over the first 5 days. After stabilization participants will be randomized based~     on sex, amphetamine withdrawal questionnaire score, and methamphetamine selective severity~     assessment score to either continued treatment with amphetamine/d-amphetamine or placebo for~     2 weeks. All subjects will then be placed on placebo for the last 7 days. The investigators~     hypothesis is that stopping amphetamine administration in methamphetamine dependent~     individuals will negatively impact mood, sleep and cognitive function in a time-limited~     fashion that may differ depending upon the measure and that attentional, but not~     pre-attentional, measures will be adversely affected in those receiving placebo compared to~     those maintained on amphetamine.~   "
179464|NCT01215916|"~     The primary objective of this study is to determine the MTD regimen for the combination~     therapy of LY573636 and pemetrexed that may be safely administered to patients with a solid~     tumor that is not amenable to curative therapy.~   "
179465|NCT01215903|"~     The present study was conducted to test whether a fish gelatin supplement combined with an~     omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects~     on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure,~     lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men~     and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity,~     glucose tolerance, lipid profile and reduces inflammation in obese or overweight~     insulin-resistant men and women.~   "
179466|NCT01215890|"~     The occurrence of bone loss in Crohn's disease patients is an important clinical problem for~     both patients with and without active disease. While therapy does exist for treatment and~     prevention of low BMD, evidence of its efficacy in Crohn's disease patients is lacking. The~     current standard of therapy in Canada for the treatment of osteoporosis is etidronate, with~     adequate calcium and vitamin D supplementation.~      The primary objective of the study is to assess the efficacy of risedronate, compared to~     placebo, administered once-weekly, in the treatment of low BMD of the spine and hip in~     patients with Crohn's disease at 12 months, based on an intention-to-treat analysis.~   "
179467|NCT01215877|"~     The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination~     with other chemotherapy agents are active in patients with advanced and metastatic bladder~     cancer, and agents of this class are a promising treatment option for some patients.~      Tesetaxel is an orally administered taxane that is in development as treatment for subjects~     with advanced cancers. This study is being conducted to determine the efficacy and safety of~     tesetaxel administered to patients previously treated with chemotherapy for progressive~     metastatic transitional cell carcinoma of the urothelium.~   "
179468|NCT01215864|"~     This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor~     of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of~     this study are to evaluate the safety of the drug and to determine the maximum tolerated dose~     and appropriate dose for phase II studies. Secondary objectives are to measure the efficacy~     of TCD-717; and in a substudy to be conducted in the MTD confirmation cohort only, to~     evaluate the potential correlation between the levels of tumor choline and tumor response to~     the choline kinase alpha inhibitor, TCD-717, using magnetic resonance spectroscopy.~     Pharmacokinetics analysis will be performed on patients enrolled in the maximum tolerated~     dose confirmation cohort.~   "
179469|NCT01215851|"~     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral~     administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with~     pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of~     change of log CFU in sputum over the time period Day 0-14 in participants with smear positive~     pulmonary tuberculosis (TB). A control group will receive standard treatment.~   "
179470|NCT01215838|"~     The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better~     at diagnosing liver lesions.~   "
179471|NCT01215825|"~     It is well established that steroid use is a benefit in the treatment of chronic obstructive~     pulmonary disease (COPD) with acute exacerbation (AE). But it is still debated about the~     regimen and dosage of steroid use. From this retrospective review of medical charts, the~     researchers investigated the therapeutic impact of various steroid dosages in COPD with AE.~   "
179472|NCT01215812|"~     The aim of this study was to analyze victims, assailants, assaults, evidentiary examinations~     and treatment characteristics of cases of sexual assault sought emergency care at Far Eastern~     Memorial Hospital、National Cheng Kung University Hospital、Taoyuan General Hospital,~     Department of Health, Executive Tuan, R.O.C.、National Taiwan University Hospital Yun-Lin~     Branch、Hospital and National Taiwan University Hospital.~   "
179473|NCT01215799|"~     This is a Phase II open-label study evaluating the preliminary efficacy and safety of~     bafetinib administered as 240 mg orally twice daily in subjects with Hormone Refractory~     Prostate Cancer.~   "
179474|NCT01215786|"~     This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3~     doses of AGN-207281 based on an ongoing review of data during the study period compared with~     timolol ophthalmic solution or placebo in patients with ocular hypertension or primary~     open-angle glaucoma.~   "
179556|NCT01214707|"~     Characterization of the cardiac response (ECG) preceding an epileptic seizure.~   "
179476|NCT01215760|"~     Objectives: To develop a protocol for early treatment using sensory reeducation through the~     mirror after surgical reconstruction of the median nerve and / or ulnar hand, and its~     comparison with the evolution of the return of skin sensitivity after a not early~     rehabilitation which will be conducted by physiotherapists, with blinding of the evaluators.~   "
179477|NCT01215747|"~     The primary purpose of this study is to assess the efficacy and safety of treatment with~     Kiacta in adult patients with AA Amyloidosis.~   "
179478|NCT01215734|"~     Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT)~     recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be~     significantly different from adult stem cell transplant recipients receiving standard dose~     (SD) TIV.~        -  Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza~          vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic~          stem cell transplant recipients.~      Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent~     influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody~     titers to influenza antigens compared to those who receive standard dose trivalent influenza~     vaccine.~        -  Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell~          transplant recipients influenza virus antigens included in trivalent influenza vaccine~          after high dose or standard dose trivalent influenza vaccine.~   "
179479|NCT01215721|"~     Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading~     cause of death from cancer in men. Radical prostatectomy is one of the treatment options~     available for organ-confined disease. Over 100,000 radical prostatectomies cases (total~     removal of the cancerous prostate by surgery) are performed in the United States yearly.~     Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life~     (QOL) scores due in part due to a postoperative incontinence which may require the use of~     multiple urinary pads per day. Many of these men also report debilitating irritative voiding~     symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction~     scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients~     symptoms may persist for longer periods.~      Our recent published findings suggest that instability in the bladder muscle is likely an~     underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability~     results in excess contractions of the urinary bladder ('urgency to urinate'), and can result~     in the feeling of needing to urinate more frequently. Consistent with this hypothesis of~     detrusor muscle instability, men with postoperative dribbling had more complaints with~     urgency, frequency and bother scores when queried with validated questionnaires. We suspect~     that a transient bladder muscle contraction may overcome the urinary sphincter valve~     resistance and result in the patient's dribbling of urine.~      By treating the bladder muscle instability, we expect improved postoperative continence and~     improved quality of life in patients after undergoing surgery for total removal of a~     cancerous prostate. This pilot study will assess the statistical requirements for the number~     of subjects needed for a fully 'powered' randomized prospective study to fully evaluate~     whether medications such as solifenacin significantly improve patients' quality of urinary~     life and improve postoperative urinary incontinence after surgery.~      *This study has been modified from the original protocol with the clinicaltrials.gov ID:~     NCT00581061.~   "
179480|NCT01215708|"~     The investigators objective is to study if some drugs can improve the success rate of~     extracorporeal shockwave lithotripsy for renal stones.~   "
179481|NCT01215695|"~     We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with~     general anesthesia including endotracheal intubation. Patients qualify for the trial if they~     are considered a difficult airway case as determined by measurement of common predictive~     indices for difficult intubation (see inclusion criteria). All patients will be intubated~     with a GVL. Patients will be randomly assigned to either having their ETT placed with use of~     a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a~     flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The~     randomization will be stratified as to whether patients are categorized as predicted~     difficult airway or have an immobilized cervical spine (C-collar in place).~   "
179482|NCT01215682|"~     Background: The medical and economic burden of upper respiratory tract infections (URTIs) is~     extremely high, while prevention and treatment options are limited. Therefore, there is a~     constant need for new methods in order to significantly decrease such morbidity. Extensive~     evidence shows that vitamin D is associated with respiratory health, including in the~     prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and~     can serve as a model for research in this field.~      The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D~     levels will reduce the frequency, length, and severity of URTIs and their accompanying~     functional impairment, while improving cellular immune function and physical function.~      Methods: After screening 100 competitive adolescent swimmers to obtain ~60 with low serum~     levels of vitamin D, this study group will be randomized to receive either vitamin D~     supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months.~     Participants will fill a daily questionnaire regarding frequency, length and severity of~     URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin~     D status (25(OH)D) and immune function among study participants at the beginning of the study~     and after supplementation. Physical function on land and in water will also be assessed.~      Expected results: Increase in serum 25(OH)D levels following supplementation will~     significantly decrease the frequency, length and severity of URTI's and their functional~     impairment, while enhancing the cellular immune system function and physical capacity.~   "
179483|NCT01215669|"~     This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season~     formulation of intradermal (ID) influenza vaccine as part of a post registration commitment.~      Objectives:~        -  For all groups, to evaluate compliance, in terms of immunogenicity, of the corresponding~          strength of the intradermal (ID) or intramuscular (IM) influenza vaccine Northern~          Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee for Human~          Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96~        -  For all groups, to describe the safety~   "
179484|NCT01215656|"~     The objective of the study is to evaluate the effects of a follow on formula containing the~     human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old~     infants.~   "
179485|NCT01215643|"~     The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with~     either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard~     of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and~     3. In addition, triple therapy with DEB025 plus standard of care will be applied to~     participants not achieving rapid viral response (RVR) in the different arms.~   "
179486|NCT01215630|"~     The primary aim is to study the relationship between vascular function, cardiovascular~     fitness and age in healthy subjects. Individuals with the highest cardiovascular fitness will~     have the greatest arterial inflow independent of age.~   "
179487|NCT01215617|"~     The purpose of this study is to investigate if 3 months of interval training improves~     obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep~     apnea. The working hypothesis is that 3 months of 3 weekly aerobic interval training sessions~     improve obstructive sleep apnea and sleep quality in obese patients.~   "
179488|NCT01215604|"~     The investigators propose that the translation initiation factors eIF4E and eIF4GI may be~     involved in resolution of acute inflammation (regardless of age). Furthermore, the~     investigators suggest that differences in translation initiation factors state of activation~     may contribute to inflammation. Finally, the investigators hypothesize that differences in~     translation initiation factors state of activation may underlie the immune compromised state~     of the very elderly affording additional explanation for the heightened morbidity from~     infection in this group.~      In the current study the investigators aim to test these hypotheses by measuring the levels~     of eIF4E and eIF4G, their regulators, and targets in elderly (65-84yrs) and very elderly~     (85yrs<) patients hospitalized at Meir hospital for acute infection and after their recovery~     (detailed in study design).~   "
179489|NCT01215591|"~     To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or~     less~   "
179490|NCT01215578|"~     The purpose of this study is to identify predictive molecular markers of response to~     continuous daily sunitinib at dose of 37.5 mg used in patients with poorly-differentiated~     Advanced/Inoperable NEURO-Endocrine Tumors.~      Hypothesis:~        -  To distinguish molecular markers based on their expression at the initial biopsy, their~          detection by proteomic analysis and demonstrating that tumor or vascular cells are~          straightaway sensitive to sunitinib (markers sensitivity).~        -  The presence of these markers at the initial biopsy predict the sensitivity to~          sunitinib(Positive predictive value of markers)~   "
179491|NCT01215565|"~     The purpose of this study is to evaluate the antitumor activity of sunitinib in patients with~     advanced/inoperable fibrolamellar hepatocellular carcinoma.~      Rationale: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor~   "
179492|NCT01215552|"~     This Positron Emission Tomography (PET) imaging study is designed to explore the relationship~     between HT-0712 dose level and inhibition of brain phosphodiesterase-4 activity, in order to~     optimize the dosage regimens utilized in subsequent trials.~   "
179493|NCT01215539|"~     The purpose of this study is to determine whether panitumumab in combination with~     capecitabine/oxaliplatin are effective as first-line treatment in wild-type k-ras, metastatic~     colorectal cancer patients.~   "
179494|NCT01215526|"~     Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed~     for a maximum of 3 years to estimate the progression free survival. Data on testosteron~     levels, QoL and LUTS will be collected if this information is available. Safety information~     (adverse events) will be collected.~   "
179495|NCT01215513|"~     This is an open-label, multi-centre single arm trial to investigate long-term safety and~     tolerability of degarelix in Korean patients with prostate cancer.~   "
179496|NCT01215500|"~     Patients with metastatic cancer are generally treated with chemotherapy, which has improved~     median survival compared to best supportive care. Despite this, patients continue to have~     persistent disease at sites that were initially involved with cancer. Radiation therapy is an~     effective modality for treating localized cancer but generally has been only used for~     palliation of symptoms once a patient develops metastatic disease. Since patients often have~     persistent disease after chemotherapy, the goal of this trial is to use increasing doses of~     radiation therapy to all sites of involved disease in order to determine the safety and~     efficacy of hypofractionated radiation therapy.~      The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities,~     and recommended phase 2 dose of hypofractionated radiation therapy.~   "
179497|NCT01215487|"~     Imatinib (IM) is first-line treatment for patients with newly diagnosed CML in chronic phase.~     The drug is associated with high rates of cytogenetic responses with minimal toxicity in~     approximately 80% of patients. In 20% of patients however, the disease is either initially~     unresponsive to IM (Imatinib), resistance develops within a few months, or blast crisis~     occurs early and unexpectedly following an initial response. An increasing body of clinical~     evidence indicates that single agent molecularly targeted therapy (as in Gleevec/Imatinib)~     will not cure most patients with CML, as molecular remissions are rare. There is currently no~     clinically useful predictive tests to identify AT DIAGNOSIS those patients who are destined~     to be IM failures. The authors of this study have recently demonstrated that CML~     stem/progenitor cells are biologically insensitive to IM and are also genetically unstable~     and rapidly generate IM-resistant mutants in vitro and in vivo. The team recently discovered~     that the CD34 stem/progenitor cells of newly diagnosed CML patients who subsequently fail to~     respond to IM treatment show a reduced response to IM and a higher frequency of BCR-ABL~     mutations by comparison of 14 IM non-responders with 11 IM-responders. If this finding can be~     validated in a larger prospective cohort of patients, this predictive test could be used to~     more rationally design treatment plans with early addition of alternative therapies ie:~     Dasatinib or combination therapies for patients according to their individual risk profiles.~      Hypothesis:~      The clinical response of newly diagnosed chronic phase CML patients to IM can be predicted by~     certain biological properties of their CD34 stem/progenitor cells which are variable among~     patients.~   "
179498|NCT01215474|"~     While current mutational analyses comprise exons 19 and 21 in which the majority of~     EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20~     mutations. Therefore, the investigators analyse 500 routine tumor samples with respect to the~     above mentioned exons and correlate the results to the clinical outcome. This approach will~     enable us to potentially identify patients that might in the future benefit from targeted~     therapy (EGFR-inhibition).~   "
179499|NCT01215461|"~     The purpose of this study is to better understand the factors associated with mortality and~     identify potentially preventable causes of death in neonates who die after receiving health~     care. As a result, an improved neonatal mortality classification system may be defined.~   "
179585|NCT01214330|"~     The purpose of this study is to see if it is possible to conduct a full study to determine~     whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed~     Pap test in detecting precancerous cervical lesions in females.~      Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.~   "
179500|NCT01215448|"~     This study is aimed to study the impact of wheatgrass juice and lifestyle recommendations~     (diet, physical activity and breathing exercises) on the well being, fatigue and~     hematological parameters of chemotherapy-naive patients with no evidence for symptoms of~     active oncological disease.The researchers hypothesize that both wheatgrass juice and~     lifestyle recommendations can improve patient's well-being during chemotherapy.~   "
179501|NCT01215435|"~     This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control~     when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified~     treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic~     drugs) alone.~   "
179502|NCT01215422|"~     There are two new instruments on the market that anesthesiologists use when putting a~     breathing tube into the lungs of patients. The purpose of this study is to see how easily~     anesthesiologists can learn to use them in children.~   "
179503|NCT01215409|"~     In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study,~     data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile~     dysfunction. The general objectives are to evaluate the product safety (primarily by~     recording adverse events), efficacy and patient acceptance.~   "
179504|NCT01215396|"~     A number of studies have shown that ingestion of crystalline amino acids, in particular~     branched chain amino acids (BCAA) can affect endurance performance, markers of muscle damage,~     and possibly mental focus. It seems that the longer and lower intensity events are affected~     more by consumption of BCAA. This study will test the hypothesis that BCAA availability~     limits central fatigue (the feeling of tiredness). While various aspects of performance have~     been tested no study to date has tested multiple exercise, muscular, and mental performance~     aspects in a single study. Thus, the overall purpose of this study is to determine whether an~     amino acid supplement changes the mental and physical response to prolonged exercise versus a~     placebo (carbohydrate drink).~      This nutritional supplement could be useful on two levels. Improved mental focus and~     endurance performance and decreased central fatigue and muscle soreness could be valuable for~     enhancing athlete performance. Similarly, decreased central fatigue and muscle soreness may~     increase the willingness of the general public to exercise which could translate into~     decreased health risks and increased health benefits.~   "
179505|NCT01215383|"~     Background:~      Among individuals with schizophrenia, there is an increased prevalence of obesity,~     dyslipidemia ,diabetes mellitus and related conditions such as cardiovascular disease. People~     with severe mental illnesses, such as schizophrenia, depression or bipolar disorder, have~     worse physical health and reduced life expectancy compared to the general population. Number~     of epidemiological studies of patients with schizophrenia have documented a higher incidence~     of cardiovascular disease than in the general population, and patients with schizophrenia may~     be at an elevated risk for cardiovascular disease even in the absence of antipsychotic~     treatment.~      Affinity for the H1 receptor is most closely linked to increased weight gain, although~     affinity for D2, 5-HT1A, 5-HT2C and a2-receptors may also be involved. Drug affinity for the~     H1, M3 and 5-HT2C receptors is correlated with an increased risk of diabetes.~      High-density lipoprotein cholesterol (HDL-C) concentration in the blood is independently and~     inversely associated with an increased risk of cardiovascular disease(CVD). However many~     patients with 'normal' or even 'elevated' plasma HDL experience clinical events. HDL may not~     always be atheroprotective and in some conditions, it paradoxically enhances the process of~     atherosclerosis. In addition to its role in reverse cholesterol transport, HDL shows many~     other protective properties towards atherosclerosis. HDL inhibits the chemotaxis of monocytes~     , prevents endothelial dysfunction and apoptosis, prohibit slow-density lipoprotein (LDL )~     oxidation, and stimulates the proliferation of endothelial cells and smooth muscle cells.~     These anti-inﬂammatory, antioxidative, antiaggregatory, anti-coagulant, and pro-ﬁbrinolytic~     activities are exerted by different components of HDL~      Aim of the study:~      To investigate the functional properties of HDL in psychiatric patients before and during~     antipsychotic therapy.~      Patients and methods:~      The blood will be drawn at baseline before the initiation of antipsychotic drugs and 2 months~     under the antipsychotic treatment.~      Study procedures:~      Full lipid profile including triglycerides, LDL-C, Total cholesterol, HDL-cholesterol, apo~     AI, apoAII and apoB100.~      Serum Paraoxanase Activity~      LDL oxidation and resistance to oxidation (measured by conjugated diens formation during~     incubation in the presence of copper).~      HDL composition: total and unesterified cholesterol, triglycerides and phospholipids, TBARS~     content before and after exposure to AAPH as a major indicator of oxidative stress, PON~     activity using phenylacetate as a substrate, apoA1and PAF.~      Serum parameters e.g. Diacyl glycerol acyltransferase activity, free ApoA1 and LCAT activity.~      3 [H]-Cholesterol efflux will be measured by incubating J744 macrophages with serum.~     Radioactivity will measured by β counter in the cell lysate and the medium.~      Statistical methods:~      One-way AVOVA and Student's t-test for paired samples will be used for comparison of multiple~     groups and paired samples, respectively. p<0.05 will be considered significant.~   "
179506|NCT01215370|"~     The main objective is to investigate the postprandial effect of arginine-rich protein (i.e.~     pea-protein) on metabolic control, inflammation and endothelial function after a high-fat~     meal in subjects with characteristics of the metabolic syndrome.~   "
179507|NCT01215357|"~     This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble~     in patients diagnosed with Pathological Gambling.~   "
179508|NCT01215344|"~     The purpose of this study is to study the MRD status after VELCADE based induction therapy~     (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in~     patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on~     MRD status post‐transplant. Our hypothesis is that MRD‐status will continue to increase~     significantly at 3 months post‐transplant and will validate that HDC and ASCT needs to be~     performed even when patients have achieved major response after induction therapy with novel~     agents.~   "
179509|NCT01215331|"~     Gestational diabetes mellitus takes place in 2 steps. First, it is the consequence of insulin~     resistance due to the modifications of the pregnancy hormonal environment, and second, of the~     deficiency of the beta cells of the pancreas to respond by a sufficient insulin secretion.~     This physiopathology is closely connected to the one of type 2 diabetes. Insulin, indeed, can~     remedy these 2 etiologies, but it is logical to think about using oral hypoglycemic agents~     which have been created to treat them: they are a natural choice because they improve insulin~     sensitivity (metformin, a biguanide) or insulin secretion (glyburide, a sulfonylurea). It~     also seems natural to use them in combination, glyburide being added to metformin if needed.~      OUR GENERAL RESEARCH HYPOTHESIS IS THAT: in pregnant women with gestational diabetes~     mellitus, using both oral hypoglycemic agents (glyburide added to metformin if needed) allows~     a glycemic control comparable to the one obtained with insulin, but with a better~     acceptability from women and a better health status, diabetes treatment satisfaction and~     well-being and a reduced postnatal depression.~   "
179510|NCT01215318|"~     The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and~     can potentially impaire image interpretation.~      The aim of this study is to determine the etiology of this artefact and devine potential ways~     how to prevent it.~   "
179511|NCT01215305|"~     The present study has been designed to provide current data on GERD prevalence in several~     regional areas of Greece outside the two major urban centres (Athens and Thessaloniki), to~     measure the treatment response in GERD patients, and to assess the correlations between the~     two methods of diagnosing GERD, i.e. reporting of symptoms by the patient to the physician~     and completion of the GerdQ questionnaire by the patient. Additionally, this study aims to~     provide data on the prevalence of extraesophageal symptoms in GERD patients in Greece. The~     XQS questionnaire will be applied for the identification of these patients and the assessment~     of the extraesophageal disease burden (frequency and intensity/severity). Finally, an~     association between the GerdQ and XQS scores will be attempted.~   "
179512|NCT01215292|"~     The purpose of this research study is to determine how much male hormone, testosterone, is~     necessary to maintain sperm production in the testis. This knowledge will be used to help in~     the development of a safe male hormonal contraception.~      Specific Aims:~        1. to determine if ketoconazole plus acyline will suppress intratesticular~          testosterone(ITT) to a greater degree than acyline alone.~        2. to determine if dutasteride plus acyline will suppress intratesticular~          dihydrotestosterone (IT-DHT) to a greater degree than acyline alone.~        3. to determine if anastrazole plus acyline will suppress intratesticular estradiol(IT-E2)~          to a greater degree than acyline alone.~   "
179513|NCT01215279|"~     The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients~     with chronic obstructive pulmonary disease.~   "
179514|NCT01215266|"~     The purpose of this study is to evaluate the use of Sorafenib additionally to gemcitabine and~     cisplatin in bladder cancer.~   "
179586|NCT01214317|"~     The purpose of this study is to compare the effect of combinative induction therapy with~     mitoxantrone and plasmapheresis versus induction therapy with mitoxantrone alone in cases of~     aggressive multiple sclerosis~   "
179516|NCT01215240|"~     Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart~     surgeries before they turn three years of age. The first surgery typically happens in the~     first two weeks of life. After this operation, babies come back to the intensive care unit~     with their chests open. Babies who have heart surgery retain body water after surgery and~     this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of~     the extra water. As a result, babies have to stay in the intensive care unit and on a~     breathing machine for longer.~      Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly~     cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD~     involves putting small amounts of special fluid into the belly through the catheter. This~     special fluid attracts water and is drained hourly. By allowing the belly cavity to drain,~     this helps both the heart and the lungs. This allows the chest to be closed and the breathing~     tube to be removed. The investigators are looking to see how quickly the babies, with and~     without PD, get rid of the extra water in turn shortening their stay in the intensive care~     unit and in the hospital. PD is not permanent, and only used for the first few days after the~     operation.~   "
179517|NCT01215227|"~     The primary purpose of this extension study is to assess the long-term safety and~     tolerability of preladenant in participants from parent studies NCT01155466 [P04938] and~     NCT01227265 [P07037] with moderate to severe Parkinson's Disease (PD). The study will also~     characterize the long-term efficacy of preladenant in participants with PD.~      Participants will continue to receive their stable regimen of levodopa (L-dopa) plus any~     adjunct medications during the study as prescribed by their physician. Several classes of~     adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase~     inhibitors, and dopamine agonists.~   "
179518|NCT01215214|"~     Identification and evaluation of endogenous markers for the assessment of CYP3A activity~     using metabolomics.~   "
179519|NCT01215201|"~     This study tries to determine whether the additional use of laser with cleaning (known as~     scaling and root planning) will result in the reduction of inflammation, reduction of~     bleeding upon examination and reduction of pocket depth in patients who are being maintained~     on a regular basis but have pocket depths that are ≥5mm with bleeding. When a pocket is~     bleeding, it is inflamed. It is usually cleaned with periodontal instruments (root-planed)~     to establish health. Some research also advocates using laser therapy to treat a bleeding~     pocket. Laser therapy is presently being performed in some dental offices and dental~     colleges. This research is trying to see if the additional laser therapy is beneficial.~   "
179520|NCT01215188|"~     This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of~     the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13™ based on immune~     responses to the 13 serotypes in common Prevnar 13™~   "
179521|NCT01215175|"~     This study is being conducted to evaluate the safety, tolerability, and immunogenicity of~     15-valent Pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and~     toddlers.~   "
179522|NCT01215162|"~     The study is being done to determine the tolerance to single fraction intra-operative~     electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy~     for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost~     irradiation that is usually given after EBRT. Data from two centers as well as preliminary~     data from a randomized trial in Europe suggest that IOERT boost is well tolerated and~     efficacious. In our study, patients will undergo standard lumpectomy and sentinel lymph node~     sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy will be delivered in a~     single fraction to the tumor bed by a mobile electron machine in the operating room. EBRT to~     the whole breast will be administered once the surgical wound has healed adequately. The~     primary objective is to determine the feasibility and acute patient tolerance to IOERT and~     EBRT after lumpectomy. Secondary objectives include assessment of local control and distant~     control of disease, as well as evaluation of long-term side effects and cosmetic outcome of~     the treatment.~   "
179523|NCT01215149|"~     The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and~     Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and~     homologous prime-boost regimens at different time intervals.~   "
179524|NCT01215136|"~     The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel~     as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma.~   "
179525|NCT01215123|"~     This observational study will assess the median time of treatment duration and the safety of~     Avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer. Data~     will be collected for approximately 24 months.~   "
179526|NCT01215110|"~     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral~     administration of TMC207 at multiple doses as determined by the rate of change of log10~     colony forming units (CFU) per ml sputum over the time period Day 7-14 in participants with~     smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.~   "
179527|NCT01215097|"~     In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of~     Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of~     treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient~     glycaemic control.~   "
179528|NCT01215084|"~     The primary objective of the study is to determine the Pharmacokinetic (PK) and safety~     profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The~     secondary objective of this study is to compare the PK and safety profiles of fampridine-PR~     10 mg among the Chinese, Japanese, and Caucasian adult healthy volunteers.~   "
179529|NCT01215071|"~     This trial evaluates the therapeutic benefit of extended versus limited lymphadenectomy at~     the time of radical cystectomy in patients with bladder cancer.~   "
179530|NCT01215058|"~     The purpose of this study is to assess gastroprotective agent compliance in patients at risk~     suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer with NSAID.~   "
179531|NCT01215045|"~     Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR~     Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain~     spectacle freedom.~   "
179587|NCT01214304|"~     The purpose of this study is to determine whether aromatherapy with lavender oil compared to~     placebo lowers anxiety levels in women during colposcopy.~   "
179532|NCT01215032|"~     Metformin is a medication that is prescribed for people with diabetes to help the body~     respond better to its own insulin and decrease sugar production by the liver. This helps~     control the body's blood sugar level and is approved by the Food and Drug Administration~     (FDA) for the treatment of diabetes. Participant's in this research study will already be~     receiving androgen deprivation therapy (ADT) for prostate cancer. ADT is considered standard~     of care for prostate cancer. Changes in the participant's metabolism, including changes in~     insulin and blood sugar levels, are often seen as a result of this type of hormone therapy.~     Some studies have shown a relationship between insulin and prostate cancer. These studies~     have suggested that insulin may signal tumor cells to grow. Other studies suggest that people~     receiving metformin treatment for diabetes may enjoy better outcomes from their prostate~     cancer then other similar patients who are not treated with metformin.~   "
179533|NCT01215019|"~     Osmotic therapy is a mainstay in the treatment of intracranial hypertension after traumatic~     brain injury.This study proposes to compare two hypertonic saline agents in patients with~     traumatic brain injury.~   "
179534|NCT01214993|"~     The current study is designed to confirm the mechanism behind the increase in serum~     creatinine observed during GSK1349572 therapy; specifically, the study will determine whether~     GSK1349572 has any effect on glomerular filtration rate (GFR) or effective renal plasma flow.~     Absent such effects, one may conclude that the small increases in serum creatinine observed~     are due to the inhibition of the tubular secretion of creatinine via organic cation~     transporter 2 (OCT2) consistent with in vitro data. .~   "
179535|NCT01214980|"~     Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split~     thickness donor sites expected to be between 20 and 200 square cm will be consecutively~     screened for study eligibility. This study is a prospective, randomized, controlled trial~     evaluating effect of MIST Therapy on the healing of split thickness skin graft donor sites~     compared to standard care. Subjects meeting all eligibility criteria and providing~     appropriate written informed consent will be enrolled for study participation.~   "
179536|NCT01214967|"~     Premature infants are born at substantial risk for poor health and developmental outcomes,~     which commonly include hearing and vision problems, developmental delays, and poor school~     performance. Premature infants of low-income families face additional social risks known to~     worsen these outcomes. The Institute of Medicine recognized this important public health~     problem in its 2006 report, Preterm Birth, which argued for the need to improve the quality~     of follow-up care for preterm infants discharged from the neonatal intensive care unit~     (NICU). The underpinning of this proposal is that maternal depression - common among families~     of premature infants - interferes with adherence to follow-up services, and (both through~     this mechanism and directly) adversely impacts child health and development. Conversely,~     alleviating depressive symptoms among these women represents a promising strategy to improve~     adherence to NICU follow-up services and to improve the outcomes of this vulnerable~     population.~      This project aims to mitigate the adverse effects of maternal depression in this specific~     high-risk population by testing a theory-based, parent-directed empowerment strategy, called~     Problem Solving Education (PSE). In the past, similar strategies have been proven effective~     for improving the mood and functioning of depressed adults, and for improving adherence to~     medical treatment. However, they have never been tested in the setting of a parent-child~     relationship or among families of premature infants.~      This project involves a clinical trial of PSE among 50 low-income mothers at risk for~     depression, who have premature infants in two Boston NICUs: Boston Medical Center and Tufts~     Medical Center. The investigators aim to determine the impact of PSE on maternal depressive~     symptoms and functioning, and adherence to child health supervision and immunization~     schedules, vision screening, and early intervention evaluation for babies with suspected~     developmental delays.~      Approximately 100,000 children are born prematurely to low-income families each year.~     Parent-directed PSE aims to improve outcomes for these children through the prevention and/or~     attenuation of maternal depressive symptoms, as well as through family activation and~     promotion of adherence to follow-up care. If successful, PSE could also provide the~     cornerstone of a more generalizable empowerment strategy for families of children with~     chronic medical conditions.~   "
179537|NCT01214954|"~     The purpose of this study is to determine whether supervised progressive resistance training~     is effective in the early phase after Total Hip Replacement. The investigators hypothesise~     that 10 weeks of supervised, progressive resistance training immediately after discharge will~     lead to increased functional performance, muscle strength and muscle power compared to~     standard rehabilitation consisting of home-based exercise.~   "
179538|NCT01214941|"~     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and~     neuropathic pain. After oral administration, tramadol is rapidly and almost completely~     absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed~     by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation~     is catalysed by CYP2D6. The formation of inactive metabolites is catalysed by CYP3A4 and 2B6.~     This study is aimed to investigate the possible interaction of oral tramadol with~     itraconazole and ticlopidine, which are inhibitors of CYP3A4 and 2B6. Twelve healthy male or~     female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the~     ideal weight for height are taken into the study. Primary endpoints of the study are plasma~     concentrations of tramadol and its metabolites.~   "
179539|NCT01214928|"~     Vitamin D is a prohormone obtained through diet, supplementation, or sun exposure. Once~     absorbed, this nutritional vitamin D undergoes a two-step reaction in the liver and in the~     kidney to become the active hormone, calcitriol. Besides the kidney, many other body tissues~     are capable of local vitamin D activation. This local tissue activity is important for~     maintenance of health and relies on adequate levels of nutritional vitamin D. Not only are~     dialysis patients deficient in calcitriol due to kidney failure, but they are also deficiency~     in nutritional vitamin D. Low levels of vitamin D have been associated with higher rates of~     death, heart and blood vessel disease, osteoporosis, falls, cancer, and autoimmune diseases.~     Despite this, there is a lack of randomized controlled trials (RCT) examining the effects of~     nutritional vitamin D in hemodialysis (HD) patients. The investigators hypothesize that~     long-term supplementation with nutritional vitamin D in HD patients improves survival and~     cardiovascular outcomes. Before embarking on a large scale RCT, the investigators propose a~     small pilot RCT with 20 hemodialysis patients to: i) To determine the effects of~     cholecalciferol (vitamin D3) in raising blood vitamin D levels; ii) To determine the~     feasibility and barriers to successful randomization and adherence to treatment protocols,~     which will inform subsequent studies.~   "
179540|NCT01214915|"~     The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide~     Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's~     previously treatment has either not been effective or has caused unacceptable adverse~     reactions. The study will aim to show that platelet counts can be safely reduced in treated~     patients to below 600 x 10^9/L after a minimum of three months treatment. To demonstrate an~     positive effect platelet levels will need to remain below 600 x 10^9/L for at least 4 weeks.~   "
179541|NCT01214902|"~     The research objectives are to test the efficacy of a Modified CIMT treatment in babies~     diagnosed with hemiplegia, treated in a home program, as compared to a control group of~     babies receiving a parallel home program but with no CIMT.~   "
179542|NCT01214889|"~     This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine~     versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.~      Primary Objective:~      To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus,~     Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to~     acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's~     TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the~     three-dose primary vaccination.~   "
179543|NCT01214876|"~     A longitudinal study on immune responses in relation to protection against clinical malaria~     episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited:~     children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25 and~     above (n=125). After finger prick sampling (~300µL) and examination at enrolment,~     participants will be followed up for one year. Follow-up will include fortnightly active case~     detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the~     associated clinical and parasitological parameters will be related to immunological profiles~     determined utilizing a protein microarray as a capture substratum to profile the humoral~     immune response against a vast number of parasite antigens.~      For individuals who experience a clinical malaria attack or who are diagnosed with high~     density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood~     sample is obtained to determine the diversity of parasite antigens in the population in~     relation to antigen recognition in the cohort.~   "
179544|NCT01214863|"~     This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric~     Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.~   "
179545|NCT01214850|"~     The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal~     vaccines on carriage of Neisseria meningitidis in a young adult population.~   "
179546|NCT01214837|"~     The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant~     vaccination schedule including kinetics of immune response in the early phases of the series.~   "
179547|NCT01214824|"~     To demonstrate that in patients with persistent poorly controlled diabetes,~     short/intermittent use of continuous glucose monitoring can driver better longer-term~     glycaemic control and HbA1c.~   "
179548|NCT01214811|"~     The purpose of this study is to evaluate the change in signs of inflammation/local infection~     when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers~     (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of~     topical antimicrobial treatment according to the physician.~   "
179549|NCT01214798|"~     Traumatic sesamoid displacement of the first metacarpophalangeal joint can affect thumb~     function.~   "
179550|NCT01214785|"~     The study is a cluster-randomized, controlled trial conducted among 100 villages (including~     approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India.~     The study aims to assess the impact of the construction and use of latrines in rural settings~     on diarrhoeal disease, helminth infections and nutritional status. The study will also report~     on the cost and cost-effectiveness of the intervention and its impact on lost days at school~     and work as well as on expenditures on drugs and medical treatment. The study will document~     how the intervention actually impacts exposure to human excreta along principal transmission~     pathways by evaluating the impact on (i) faecal contamination of drinking water, (ii) the~     presence of mechanical vectors (flies) in food preparation areas, and (iii) the presence of~     faeces in and around participating households and villages. The study will also explore the~     extent to which different levels of acquisition and use of on-site sanitation among~     householders impact disease throughout the community.~   "
179551|NCT01214772|"~     Embryo transfer failure is defined as ≥3 IVF-embryo transfer failures without pregnancy . In~     spite of transfer of 3 good quality embryos , just 20-30% of women undergoing IVF will~     achieve ongoing pregnancy . There are multiple factors that influence IVF-failure.~      Autoantibodies may be one of the possible causes of IVF-failure , especially in unexplained~     and mechanical infertility .~      In some studies , antiphospholipid antibody is considered as causative factor on implantation~     and embryo failure. However some investigators showed that combination therapy with~     heparin/aspirin in women with positive antiphospholipid antibody is not effective in~     improving of IVF-outcome . In prospective studies were not confirmed association between~     antiphospholipid antibody abnormalities and IVF-failure.~      Recently has been relationship between thrombophilia and IVF and implantation failure.~      The effect of unfractionated heparin in assisted reproductive technology (ART) cycles is~     prevention of thrombosis in implantation site . Although its effect is not restricted to~     anticoagulation and also can modulate apposition , adhesion , and penetration of embryo .~     Other advantages are decreasing thrombophilic risk in COH ( controlled ovarian~     hyperstimulation) cycles with administration of gonadotrophins . So heparin make better~     pregnancy rate in repeated IVF-ET failures.~      There are few studies in regard to heparin effects on IVF cycles outcome . The purpose of~     this study is evaluation of unfractionated heparin effects on improvement of ART outcome .~      This study was a prospective randomized controlled trial to assess whether administration of~     heparin would increased pregnancy rates in women with repeated ET-IVF failures.~   "
179552|NCT01214759|"~     This study will evaluate the safety and tolerability of the combination of truvada and~     raltegravir given for 28 days for the prevention of HIV infection.~   "
179553|NCT01214746|"~     It has been documented that statin reduce mortality and morbidity in patients with~     cardiovascular disease. This effect can partly be related to a reduction in cholesterol~     levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as~     nephropathy, diabetes and hypertension. The purpose of this study is to investigate the~     effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular~     variables in healthy man.~   "
179554|NCT01214733|"~     This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra~     (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients~     with moderate to severe rheumatoid arthritis. Patients who successfully completed studies~     WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will~     be allowed DMARDs according to the treatment they received in the previous studies. Patients~     will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on~     study treatment is 104 weeks.~   "
179557|NCT01214694|"~     The purpose of this study is to test two on-line interventions for families of young children~     who have experienced moderate or severe traumatic brain injury (TBI). This project builds~     upon the investigators' previous research by modifying the online intervention content to~     address the needs of young children with TBI. The goal of this project is to develop an~     intervention that will encourage positive parenting behaviors, improve child behaviors, and~     reduce parent distress and burden following TBI. The investigators hypothesize that the~     intervention groups will exhibit more effective parenting skills as well as better child~     functioning and lower levels of parental distress at follow-up than will the active~     comparison group.~   "
179558|NCT01214681|"~     Colorectal cancer is a common disease worldwide. It is now thought that colorectal cancer~     cells arise from stem cells where the genetic material regulating growth and division of the~     stem cell has become defective. This leads to unregulated production of cells which in turn~     have defective genetic information and cancer formation.~      Research into colorectal cancer is hampered by the fact that studies must take a very long~     time to produce results and be very large if the development of a cancer is the endpoint.~     Therefore alternative methods of quantifying the risk of developing a cancer are required so~     trials can be a realistic size and be completed in a realistic time frame. The investigators~     have previously identified several candidates for these 'biomarkers'. The next stage in~     proving or disproving these as useful biomarkers is to test their response to a dietary agent~     that the investigators know reduces the risk of colon cancer.~   "
179559|NCT01214668|"~     The goal of this study is to determine the dose of LY573636 that can be administered safely~     in combination with liposomal doxorubicin in patients with advanced cancer who have failed a~     prior treatment.~      The study consists of a dose escalation phase to the maximum tolerated dose (MTD)and a dose~     confirmation phase in patients with platinum resistant epithelial ovarian, fallopian tube or~     primary peritoneal cancer who have never been treated with doxorubicin.~   "
179560|NCT01214655|"~     This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient~     dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355~     that can be safely administered to patients with acute leukemia. Part A and Part B are dose~     escalation of two schedules in patients with acute leukemia. Parts A and B will enroll~     concurrently. Part C is a dose expansion for each schedule in patients with acute~     myeloblastic leukemia (AML).~   "
179561|NCT01214642|"~     This study is being conducted to determine the safety of LY2523355 for the treatment of~     advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).~   "
179562|NCT01214629|"~     This study is being conducted to determine the safety of LY2523355 for the treatment of~     advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).~   "
179563|NCT01214616|"~     -  To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine~          i.v. by assessment of Dose Limiting Toxicities (DLT);~        -  To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics~          of afatinib and vinorelbine i.v.~   "
179564|NCT01214603|"~     Study JWYB is a multicenter, non-randomized, open-label, Phase 2 study of intravenous~     LY2090314 in participants with acute leukemia.~   "
179565|NCT01214590|"~     The purpose of this study is to assess the safety and the preliminary efficacy of treatment~     by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect~     with physiologic changes.~      Patients will undergo a 4-week period of home treatment by the VascuActive device, and will~     be monitored during this period and during a two-month follow-up period for the efficacy of~     the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.~   "
179566|NCT01214577|"~     This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel,~     0.015% when administered for up to three consecutive days to photo-damaged skin on the face.~     The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered~     for up to three consecutive days in patients with photo-damaged skin on the face.~   "
179567|NCT01214564|"~     This study is primarily designed to investigate whether treatment, once daily for up to three~     consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in~     patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to~     investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive~     days to Seborrhoeic Keratosis on non-head locations.~   "
179568|NCT01214551|"~     The purpose of this study is to increase the knowledge of the possible diagnostic effect of~     exercise induced bronchoconstriction performing a repeated exercise challenge test.~   "
179569|NCT01214538|"~     This clinical study is designed to assess prospectively the sero-responses to various~     proteins in cases of pneumococcal Acute Otitis Media.~   "
179570|NCT01214525|"~     The improvement in uroflow and postvoid residual urine in children after urethral meatotomy~     for meatal stenosis. The hypothesis is that there is an improvement in both parameters, thus~     justifying the procedure.~   "
179571|NCT01214512|"~     This study is aimed to evaluate the performance of the Micromedic CD24 assay in identifying~     colorectal adenoma using Western blot and ELISA assays. These assays are designed to detect~     CD24 protein in peripheral blood leukocytes (PBL). Elevated levels of CD24 may be indicative~     of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and~     cancer).~   "
179588|NCT01214291|"~     The purpose of this study is to determine whether Toremifene Citrate is effective in reducing~     the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation~     Therapy.~   "
179589|NCT01214278|"~     The aim of this study is to examine differences in short term bioavailability between four~     n-3 FA formulations in healthy males.~   "
179590|NCT01214265|"~     To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior~     tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented~     overactive bladder.~   "
179591|NCT01214252|"~     To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in~     the treatment of abdominal wall defects.~   "
179592|NCT01214239|"~     In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of~     Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of~     treatment in monotherapy in patients with type 2 diabetes and insufficient glycaemic control.~   "
179572|NCT01214499|"~     Coronary disease is one of the most frequent pathology of the modern world and the leading~     cause of death in the investigators country. In Spain more than 50.000 coronary percutaneous~     intervention and more than 5.000 coronary artery bypass graft (CABG) procedures are performed~     every year. Despite this data about 12% of patients have diffuse coronary disease and are not~     candidates to conventional therapies. Also between 15-25% of patients undergoing coronary~     bypass grafting receive an incomplete revascularization due to the poor quality of the~     coronary vessels.~      Transmyocardial revascularization (TMR) is a surgical procedure that uses a laser to create~     channels through the myocardial, so this laser stimulates local angiogenesis and provides~     blood in the ischemic area. Results of this procedure have shown clear benefits in terms of~     reduction of angina and increase of survival of patients, compared to medical treatment.~      Cell therapy in heart disease is offering in recent years encouraging results despite the~     methodological difficulties that being able to use this technique sometimes involves. The~     basis lies in the potential ability of stem cells to differentiate into any type of adult~     cell. In the case of cardiac cell therapy, stem cells can differentiate into myocardial cells~     or vascular cells capable of developing angiogenesis. Further studies are needed to draw firm~     conclusions about the clinical impact that the use of stem cells has on cardiovascular~     disease.~      Recently a system has been developed to create, at the same time and in a simple and~     effective way, the laser channels and the introduction of stem cells on the edges of these~     channels. This system called PHOENIX ™ consists of a laser probe capable of creating~     transmural channels in the myocardium.~      Based on the what has just been explained, it is quite possible that the combination of both~     therapies can increase successful results regarding the reduction in angina these patients~     need. Initially, and after having some experience with this type of treatment, the results~     could be analyzed and compared with the results obtained through laser therapy, with the help~     of a controlled clinical trial, such as the one the investigators are proposing.~   "
179573|NCT01214486|"~     The primary purpose of this study is to analyze and compare plasma and intracellular~     concentrations of Raltegravir (RAL) in blood plasma and in peripheral blood mononuclear~     cells, using high performance liquid chromatography (HPLC).~   "
179574|NCT01214473|"~     Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and~     mortality in the newborn period around the world. India, with one of the world's largest~     populations, continues to struggle with extremely high infant and neonatal mortality rates.~     Sepsis accounts for 50% of deaths among community born (and 20% of mortality among~     hospital-born) infants. Closely linked with this is a burgeoning problem of antimicrobial~     resistance, which is increasingly restricting the therapeutic options for medical care~     providers. Friendly bacteria called Probiotics have been used in multiple infectious and~     inflammatory disease states in humans. Fructooligosaccharides are sugars found naturally in~     many fruits and vegetables and also in human breast milk. These sugars reach the colon~     undigested and serve as food for the friendly bacteria. The current study uses a probiotic~     preparation containing Lactobacillus plantarum and fructooligosaccharides as an attempt to~     prevent neonatal infections. Currently no conclusive data are available on the utility of~     probiotics in such conditions. If successful, such inexpensive preventive therapy can be made~     available to general public in resource poor countries. Similar preparations can also be used~     in the western world to prevent similar infectious conditions of the neonatal period,~     especially in preterm infants where sepsis continues to be a major cause of hospital stay and~     death.~   "
179575|NCT01214460|"~     Patients in general wards have abnormal physical values preceding in-hospital cardiac arrest~     or a transfer to intensive care unit (ICU). The purpose of Medical Emergency Team (MET) or~     EMS is to interfere early enough in deteriorating patient status to prevent adverse outcomes~     like cardiac arrest or transfer to intensive care unit. The aims of this study are to record~     and analyze the effects of EMS and department of emergency and both afferent and efferent~     limbs of MET activity in Finnish tertiary Hospital.~   "
179576|NCT01214447|"~     This prospective observational study is planned to validate OSND against the prospective~     morbidity and mortality in chronic hemodialysis patients and to examine the hypothesis that~     OSND risk stratification of chronic HD patients is useful in predicting outcomes and better~     than its component alone or in diverse combinations. The investigators specific aim is to~     validate OSND in chronic HD patients by comparing it with conventional measures of~     nutritional state, including blood tests, anthropometry, MIS, GNRI, bioelectric impedance~     analysis and several measures of clinical outcome including prospective mortality and~     hospitalization.~   "
179577|NCT01214434|"~     The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in~     cradle cap.~   "
179578|NCT01214421|"~     To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from~     baseline (from trial 156-04-251) in total kidney volume (TKV) and renal function.~   "
179579|NCT01214408|"~     This prospective, open label, single-center and non-comparative study is designed to generate~     data on Digene Total's (buffered pantoprazole) rapid and sustained gastric acid inhibition~     effect in patients suffering from acid peptic disorders.~   "
179580|NCT01214395|"~     This study will compare the use of tea tree oil as a topical nasal antiseptic to prevent~     infections in patients that need renal dialysis. A maximum of fifty subjects will be~     recruited and will be assessed for signs of infection once per week for the first 6 weeks and~     then every 4 weeks until week 26. They will also be checked for nasal carriage of 'Golden~     Staph' when they enroll in the trial. The subjects will complete the trial if they have 26~     weeks infection-free or if they have an infection during that period~   "
179581|NCT01214382|"~     This study is being conducted to evaluate how the body absorbs and processes the medication~     sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric~     bypass surgery. Participants will be asked to take part in this study at three time points:~     1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve~     months following surgery. This study will enroll approximately 30 participants.~   "
179582|NCT01214369|"~     -  Hypothesis:~             -  X-tip intraosseous is an effective supplementary injection in mandibular hot teeth~               as well as Periodontal Ligament (PDL) injection~        -  Purposes:~             -  Comparing the anesthetic efficacy of X-tip intraosseous and PDL injection in~               mandibular hot teeth which had not been anesthetized after 3.6 ml Infra Alveolar~               Nerve Block~        -  Methods and Materials:~             -  forty patients with mandibular hot molar or second premolar which had not been~               anesthetized after 3.6 ml inferior alveolar nerve block injection will be selected~               for this study~   "
179583|NCT01214356|"~     This purpose of this project is to evaluate the effectiveness of vitamin D supplementation~     over 12 months in vitamin D deficient African American adults with type 2 diabetes.~   "
179584|NCT01214343|"~     The purpose of this study is to evaluate the efficacy of sorafenib in combination with low~     dose cisplatin /fluorouracil hepatic arterial infusion chemotherapy in patients with advanced~     hepatocellular carcinoma.~   "
179660|NCT01213355|"~     It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive~     impairments in healthy adults subjects.~   "
179593|NCT01214226|"~     The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for~     clinicians involved in the management of severe alcoholic liver disease. In patients with~     Maddrey function higher than 32, compelling evidence from data has shown that corticosteroids~     improve short-term survival. However, novel strategies or molecules are required in light of~     the fact that approximately 40 % of patients continue to die at 6 months. A double-blinded~     randomized controlled trial of 101 patients has showed that Pentoxifylline improves survival~     of patients with severe AH, as compared to placebo. In terms of mechanisms, the effect of~     pentoxifylline is related to prevention of hepatorenal function whereas corticosteroids~     induce an early improvement in liver function. When considering these differences of~     mechanisms, many clinicians suggest that the addition of pentoxyfilline to corticosteroids is~     an attractive option that needs to be tested in patients with severe AH.~   "
179594|NCT01214213|"~     There is evidence for altered muscle activity patterns in individuals with non-specific~     chronic back pain (NSCBP). It is unknown why these alterations in activation pattern occur~     and how they may be linked to pain experience and to the development of CNSBP. The main~     objective of this study is to investigate the spatial aspects of muscle activation in~     relation to fatigue/endurance and CNSBP. A novel approach, utilizing a new multi-channel~     surface-EMG (MCsEMG) technique will be applied in this project to get insight in fundamental~     mechanisms related to motor control and fatigue/endurance. In this project data from healthy~     persons and from patients with NSCBP will be collected and analyzed. NSCBP patients will be~     compared to healthy persons. To minimize heterogeneity between groups the subject's age range~     will be from 30 - 50 years. The investigators main hypothesis is that motor control~     mechanisms of the lumbar muscles are disturbed in NSCBP patients compared to normals,~     explaining the reduced tolerance for static postures. There has been little investigation of~     the lumbar musculature with MCsEMG recordings. The lumbar musculature has a complex~     organization; many, relatively small muscles, in a restricted area. Utilizing two HDsEMG~     grids with 252 Ag/AgCl contacts will be the superior non-invasive method to investigate motor~     control mechanisms in this region, and further the investigators understanding of~     neuromuscular adaptations related to NSCBP. The project may demonstrate changes that will~     lead us to new insight and new strategies for the treatment of back pain.~   "
179595|NCT01214200|"~     The purpose of this pilot study is to evaluate the effect of high intensity non-invasive~     positive pressure ventilation (HINPPV) for stable, hypercapnic COPD patients. The~     investigators believe that HINPPV, used at least 6 hours nocturnally over three months, will~     benefit the stable hypercapnic COPD patient through a reduction in the daytime partial~     pressure of carbon dioxide in arterial blood (PaCO2) levels.~   "
179596|NCT01214187|"~     The purpose of this study is to determine whether low concentration inhaled carbon monoxide~     is effective in treating idiopathic pulmonary fibrosis.~   "
179597|NCT01214174|"~     This study will test the efficacy and safety of IBI-10090 in the treatment of ocular~     inflammation after cataract surgery.~   "
179598|NCT01214161|"~     The intrauterine device (IUD) is a form of birth control that is extremely effective and~     safe, even in women who have not yet had children. Women can experience high levels of pain~     when the IUD is placed inside the uterus, and fear of this pain could be a reason that women~     decide not to use this method.~      This study will randomly (like flipping a coin) assign women who have chosen the IUD as their~     contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their~     cervix prior to having the IUD inserted; the other will have an inert gel placed into their~     cervix instead. The level of pain at three different time points on a 10cm scale and the~     patient's satisfaction with the procedure will be compared between the two groups to see if~     using lidocaine gel helps decrease IUD insertional pain~   "
179599|NCT01214148|"~     A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2~     centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to determine~     the primary endpoint of late lumen loss and secondary endpoints. A subgroup of 15 patients~     will also undergo post implantation, 4 and 9 months IVUS examinations. Additional clinical~     follow-ups take place at 1 month and yearly up to three (3) years.~      The objective of this trial is to assess the safety and clinical performance of the ORSIRO~     drug eluting stent in patients with single de-novo coronary artery lesions.~   "
179600|NCT01214135|"~     The primary objective of this non-interventional study is to investigate how Seroquel XR and~     Seroquel IR are used in the clinical practice of inpatients with schizophrenia. This will be~     done by a retrospective review of medical records to evaluate patients treated with Seroquel~     XR or Seroquel IR as primary antipsychotic treatment.~   "
179601|NCT01214122|"~     The primary purpose of this study is to determine whether the treatment with AZD9668 will~     affect the metabolism and effect of Warfarin.~   "
179602|NCT01214109|"~     To establish bioequivalence at steady state of:~      1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg~     pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended~     release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet~     t.i.d. in fasted status~      To investigate dose proportionality of pharmacokinetics parameters for:~      1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.~   "
179603|NCT01214096|"~     Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous~     Administration in Patients With Chronic Systolic Heart Failure~   "
179604|NCT01214083|"~     The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine +~     high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in~     reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than~     low-dose naltrexone (50 mg) alone in reducing alcohol drinking.~   "
179605|NCT01214070|"~     The objective of this study is to test functional vision outcome measures that reflect the~     loss in everyday life tasks that require vision and that are sensitive to changes after a~     course of vision rehabilitation in Veterans/participants with TBI.~   "
179606|NCT01214057|"~     The purpose of this study is to compare total intravenous anesthesia to inhaled anesthesia in~     endoscopic sinus surgery for chronic sinusitis. The investigators will compare bleeding~     during surgery, duration of surgery, blood flow to the nose and other parameters. The~     investigators hypothesize that total intravenous anesthesia decreases bleeding and improves~     the view during surgery.~   "
179607|NCT01214044|"~     The goal of the study is to obtain preliminary data that will test whether the antidepressant~     medication escitalopram resets the body clock: a collection of nerve cells in the brain that~     control the timing of many body processes. The study will also test whether the improvement~     in depression symptoms with escitalopram correlates with the degree to which the timing of~     the body clock is properly aligned with the timing of sleep.~   "
179608|NCT01214031|"~     Chromoendoscopy (that involves spraying of dyes over the colonic mucosa) combined with~     magnification has been utilized for polyp histology identification. Pit patterns on the~     surface of polyps described by Kudo et al have been shown to have a high diagnostic accuracy~     in differentiating the polyp types (18, 19). NBI, that is also referred to as electronic~     chromoendoscopy is another technique that has been evaluated for polyp histology~     identification by highlighting the superficial mucosal and vascular architecture (15, 20,~     21). pCLE is another novel addition to the technologies aiming to accomplish in vivo~     histologic diagnosis with a high degree of accuracy. The pCLE system has three major~     components (Mauna Kea Technologies, Paris, France). The first is the confocal miniprobe made~     of approximately thirty thousand optical fibers bundled together and terminated by a distal~     microsystem. The images obtained have a lateral resolution of 1µm, an axial resolution of 10~     µm and a maximum field of view of 240 µm. The depth of observation is from 55 to 65 µm. The~     miniprobe tip diameter is 2.5 mm and can be passed through the accessory channel of any~     standard endoscope. The second is the laser scanning unit (excitation wavelength - 488 nm)~     that combines the functions of laser light illumination and rapid laser scanning, enabling a~     frame rate up to 12 images per second and signal detection. The third is the control and~     acquisition software for real time image reconstruction, immediate sequences display and~     post-procedure analysis and editing tools. Once an area of interest (e.g. a polyp) is~     identified, 5 ml of 10% fluorescein sodium is injected intravenously; the confocal probe is~     passed through the accessory channel of the endoscope and placed against the lesion to obtain~     several high-quality images and video sequences. In a study by Buchner et al from the Mayo~     Clinic, Jacksonville, (22) this system was used to evaluate confocal images of 37 polyps from~     25 patients in a blinded fashion without the knowledge of their histologic diagnosis or~     endoscopic appearance. The investigators developed the following criteria that were~     suggestive of neoplastic polyps: villiform pattern, nuclear characteristics - oval/irregular~     nuclear shape and increased number of nuclei. These features had a sensitivity of 82.6%,~     specificity of 92.9% and accuracy of 86.5% for the characterization of neoplastic polyps.~     Similarly, Meining et al (23) have also evaluated criteria for differentiating neoplastic~     from benign lesions in the colon with encouraging results.~      The investigators hypothesize that pCLE will have a high rate for accurate characterization~     of polyp histology real time during colonoscopy~   "
179609|NCT01214018|"~     The goal is to compare post tramautic stress between the nearest relatives of brain-dead~     patients who are organ donor to those of brain-dead patients who are not organ donors for~     medical, legal or opposition reasons.~   "
179610|NCT01214005|"~     This project tests two hypotheses concerning the low smoking cessation rates in smokers with~     schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger~     and more sustained effects of smoking abstinence on negative mood and smoking urge than~     control smokers without psychiatric illness. The second hypothesis is that smokers with~     schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more~     rewarding effects of smoking after a period of abstinence) than control smokers without~     psychiatric illness.~   "
179611|NCT01213992|"~     The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg~     and 1000 mg) of Monofer® in patients suffering from Non-dialysis Dependent Chronic Kidney~     Disease.~   "
179612|NCT01213979|"~     The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg~     and 1000 mg) of Monofer(R)in patients suffering from non-hematological malignancies with~     Chemotherapy induced anaemia.~   "
179613|NCT01213966|"~     A Phase IIa Exploratory, Open label, Single Dose Regimen, Multiple Dose Testing Clinical~     Study to Assess the Preliminary Efficacy, Tolerability and Pharmacokinetics of OZ439 in adult~     patients with acute, uncomplicated Plasmodium falciparum or vivax malaria mono-infection.~   "
179614|NCT01213953|"~     The study is designed for evaluating the presence of mesenchymal stem cells of vertebral~     disc. Isolation and authentication of these cells may be applied for the vertebral disc~     regeneration and the research tissue engineering.~   "
179615|NCT01213940|"~     Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies~     and in the number of circulating functional replicative competent endothelial progenitor~     cells (EPC's) after bariatric surgery.~   "
179616|NCT01213927|"~     Hepatocellular carcinoma (HCC) is a major public health problem, whose incidence is~     increasing in developed countries and is the leading cause of death in patients with~     cirrhosis. The diagnosis and the early management are key issues that could improve the~     prognosis. In France, alcoholic cirrhosis is the leading cause of HCC, while the aetiology of~     underlying chronic liver disease is mainly hepatitis C (HCV) in Southern Europe and Japan,~     and hepatitis B (HBV) in Asia and Africa. In the next years, due to the improved results of~     anti-viral therapies, this trend should be reinforced with a decreasing proportion of HCC~     related to viral cirrhosis and an increasing proportion of HCC related to alcoholic~     cirrhosis. However, natural history of alcoholic cirrhosis remains poorly understood, most~     studies being retrospective and including a small number of patients. This project is filed~     by the consortium CIRRAL including French Academic hospitals centers currently involved and~     referees in the field of alcoholic liver disease and HCC (8 at the moment, and more in the~     next months). It is a national multicenter prospective study that will include 1200 patients~     with alcoholic cirrhosis histologically proven over 3 years. The main goal of this cohort is~     to describe the natural history of a large number of patients with alcoholic cirrhosis~     prospectively followed, and to identify predictors of the occurrence of HCC.~   "
179617|NCT01213914|"~     The purpose of this study is determine if High-Volume Hemofiltration in addition to~     'contemporary' care will result in an improvement of select clinical outcomes when compared~     to 'contemporary' care alone in the treatment of critically ill patients with ARF secondary~     to septic shock.~   "
179618|NCT01213901|"~     To determine which anatomic site offers the most consistent (superior) absorption of insulin.~      To determine the injection technique which allows the most consistent subcutaneous injection~     of insulin (to pinch or to spread).~      Hypothesis:~      Based on age-related changes in the amount of subcutaneous fat we anticipate that the~     absorption of insulin from various anatomical sites will differ.~      Justification:~      To date health care professionals have extrapolated data obtained from younger adults and~     applied the results to the elderly.~      Objectives:~      To determine the rate of insulin absorption from different anatomic sites in diabetic~     patients over the age of 70.~      To determine the best practice for subcutaneous injection in older adults.~      Research Method:~      Measurement of serial glucose and insulin levels using 360 minute euglycemic clamp studies.~      Statistical Analysis:~      Paired t test, repeated measures ANOVA~   "
179619|NCT01213888|"~     To evaluate the effects of Trientine Hydrochloride in prevention of post-laser (pan-retinal~     photocoagulation) macular edema in the eyes for subjects with diabetic retinopathy. Trientine~     hydrochloride can limit secondary inflammatory damage to retinal vessels following the~     administration of pan-retinal photocoagulation therapy for severe non-proliferative diabetic~     retinopathy or retinal neovascularization due to diabetic retinopathy, resulting in less~     macular edema and improved visual outcomes.~   "
179620|NCT01213875|"~     The home based intervention is a multidisciplinary approach that has shown benefit in the~     follow-up of patients with Heart Failure (HF). It is considered one of the most effective~     approaches and humanized by education and care for the patient in his environment of routine.~     In this study the monitoring of HF patients in the home after hospital discharge will include~     the reinforcement, monitoring and reassessment of previously provided guidance on the disease~     and self-care, compliance to prescribed medications and especially the early recognition of~     signs and symptoms of decompensation by patients and their caregivers.~   "
179621|NCT01213862|"~     Home visits (HV) are one of the multidisciplinary approaches that has already shown to~     benefit the follow-up of Heart Failure (HF) patients. It is considered to be one of the most~     effective and humane approaches as it educates and takes care of the patient in his/her~     routine environment. In this study, the follow-up of HF patients in a home setting after~     being discharged from hospital will include the reinforcement, monitoring and re-evaluation~     of guidelines previously provided about the disease and self-care, compliance to prescribed~     medicines and, specially, the early recognition of decompensation signs and symptoms by~     patients and their caregivers.~   "
179622|NCT01213849|"~     The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF)~     and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel~     dry powder inhaler in healthy subjects.~   "
179623|NCT01213836|"~     This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised~     crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive~     performance in patients with schizophrenia stabilized on a single antipsychotic medication.~   "
179624|NCT01213823|"~     The purpose of this study is to estimate the relative risk of severe hepatic injury in~     hospitalized patients with invasive candidiasis and candidemia who received anidulafungin,~     compared to patients who received caspofungin and/or micafungin.~   "
179625|NCT01213810|"~     The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive~     individuals. Study participants are stratified into different patient groups according to~     their CD4 cell count, viral load and HIV Status.~        -  Trial with medicinal product~        -  Trial with immunomodulatory product / biological~   "
179626|NCT01213797|"~     With 11.000 deaths and 150.000 attempts each year in France, the suicide represents an~     important public health problem. For each death by suicide, one can count 6 direct bereaved~     people and 20 people in more indirect connection with this mourning (Terra 2001). In term of~     impact, there is thus 300.000 people (annually) touched by the deaths by suicide and~     3.750.000 people (annually) touched by the suicide attempt of a close relative. It seems~     indeed important to have Public Health data on this cascade repercussion of the suicide~     attempt.~      A suicide attempt propagates a suffering cascade on the various circles of the family and~     close entourage, which can be measured in term of traumatic stress and medico-economic~     impact.~      Objective = To measure the medico-economic impact on the entourage, in the 3 months following~     the suicide attempt and at 1 year.~   "
179627|NCT01213784|"~     The investigators wish to investigate wether a more strict diabetic control improves cardiac~     function, muscle strength, exercise capacity and decreases symptoms.~      The investigators hypothesis is that improving the glycemic control in suboptimized diabetics~     with heart failure will improve cardiac performance, muscle strength, exercise capacity and~     decrease symptoms.~   "
179628|NCT01213771|"~     Background Denmark has a record-high incidence of, and mortality rate for, ovarian cancer.~     There are 600 new cases of ovarian cancer each year. In 2008 the state issued a guarantee of~     early diagnosis and treatment of all cases of suspected cancer, and surgical treatment has~     been centralised and standardised in fast track programmes. However, the investigators do not~     know how women with ovarian cancer experience the period prior to surgery and how they can~     optimally prepare for treatment and care.~      Aim The two principal aims of the study are to describe health and coping in Danish women~     surgically treated for ovarian cancer; and to examine to what extent it is possible, from~     both a patient and professional perspective, to improve the health and everyday life of~     patients with ovarian cancer.~      Materials and methods The study is conducted within the scientific theoretical framework of~     hermeneutics, involving the overall concepts of health promotion and rehabilitation. The~     study will be carried out in 4 stages between September 2008 and September 2011. Stage 1: A~     health-related characterisation of Danish women with ovarian cancer through a registration~     process. Stage 2: Qualitative research interviews with patients, to gain knowledge about~     spontaneous preoperative coping strategies and resources.~      Stage 3: The preoperative preparation programme will be developed and clinically tested. The~     effect of participation will be measured by self-assessed health and coping before and after~     surgery. The study period runs from the time the decision is taken to operate until eight~     weeks after discharge. The study takes place at the Department of Gynaecology at Aarhus~     University Hospital, Skejby in Denmark, which is a regional centre of surgical treatment of~     gynaecological cancer.~      Results The study provides insight into the preoperative coping strategies and general health~     of Danish women suffering from ovarian cancer. The development and testing of the~     preoperative preparation programme contributes to knowledge about optimisation of~     preoperative preparation. This might have a positive impact on the participants' general~     health and level of functioning during their treatment. Furthermore, the project contributes~     to knowledge of the preoperative coping strategies and experiences of (female) cancer~     patients in general.~   "
179629|NCT01213758|"~     Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the~     galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique~     provides volumetric mapping of liver function and it allows quantisation of liver function.~     The method may be used for selection of patients for stereotactic radiotherapy of liver~     tumors, for determination of radiation induced liver dysfunction and may be included into the~     treatment planning process of stereotactic radiotherapy.~   "
179630|NCT01213745|"~     This study will investigate the effectiveness of using the European Organisation for Research~     and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to~     identify and target therapies in patients with lung cancer. The study will assess whether~     using the questionnaire will result in an improvement in QoL.~   "
179631|NCT01213732|"~     In this study the recombinant human fusion protein L19TNFα will be associated in ILP with the~     standard treatment with melphalan 10mg/l limb volume in subjects affected by stage III/IV~     limb melanoma.~      The recombinant human fusion protein L19TNFα was created with the intention to target TNFα~     directly to tumor tissues with the result in high and sustained intralesional bioactive TNFα~     concentrations.~   "
179632|NCT01213719|"~     It has been suggested that betaine supplementation may improve muscle strength by increasing~     muscle creatine content. However, there is no data supporting this assumption. The~     investigators speculate that betaine supplementation could enhance intramuscular creatine~     content, which would result in strength improvements.~   "
179633|NCT01213706|"~     In the present proposal the investigators wish to assess the effect of a single session with~     the device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) on~     baseline airway blood flow (Qaw) and in Qaw variation, in current smokers,~     glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers, with the expectation~     that the treatment will transiently increase the Qaw, and to a greater extent in the current~     smokers and patients with asthma who have endothelial dysfunction.~   "
179634|NCT01213693|"~     Exacerbations are important events in the natural history of chronic obstructive pulmonary~     disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that~     exacerbations negatively affect the natural history of the disease; e.g. lung function~     decline is accelerated in patients with frequent exacerbations. Bacteria are considered the~     most relevant cause of exacerbations, but there is evidence that viral infections are equally~     contributing.~      Either alone or in combination with viruses, airway bacterial load in stable COPD correlates~     with both the frequency of exacerbations and the decline in lung function.~      A long-term clinical trial recently showed that the regular treatment with inhaled~     corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it~     reduces the frequency of acute COPD exacerbations in COPD.~      In a recent study it was found that airway bacterial load increases over time (1 yr follow~     up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.~      This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral~     and/or bacterial load in the sputum of COPD patients.~   "
179635|NCT01213680|"~     The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg~     and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease~   "
179636|NCT01213667|"~     To assess genetic features and intraocular cytokine profiles of non-responders to anti-VEGF~     treatment of exudative age-related macular degeneration. Also to assess necessity and~     frequency of pro re nate medical re-treatment.~   "
179637|NCT01213654|"~     A pilot study to observe satisfaction of analgesia with intercostal catheters after VATS~     lobectomy.~   "
179638|NCT01213641|"~     The purpose of this observational study is to collect additional information regarding~     long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical~     practice.~   "
179639|NCT01213628|"~     Eighty adult patients undergoing open colon surgery will be randomized to either:standard~     warming measures or to additional insufflation of humidified carbon dioxide in the open wound~     cavity during major abdominal surgery.~      PRIMARY AIM is to test if core and local temperature can be increased.~   "
179640|NCT01213615|"~     Since the first implant in September 1982, the Medtronic Hancock® II has provided more than~     20 years of excellent hemodynamic performance and durability. Design improvements over the~     past generations include: low profile, flexible stent, Supra-X™ supra-annular placement, T6~     anti-calcification tissue treatment, modified fixation process, CINCH® advanced implant~     system and ULTRA™ minimized sewing ring. Valve sizing is a critical consideration in~     obtaining optimal hemodynamic performance. This is particular true in small aortic roots. A~     critical issue is the size of the prosthesis in relation to the patient's annulus.~      The objective of this clinical study is to evaluate, at six and twelve months, the~     hemodynamic performance of the HancockÒ Ultra™ bioprosthesis in the aortic position, to~     analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to~     ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus~     diameter.~   "
179641|NCT01213602|"~     The principal objective is to notice the relevance of timing performance of femoral block for~     knee replacement surgery during general anesthesia and analyze the relationship with~     bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia.~     Otherwise the investigators try to investigate if the timing of performance of this block~     influence in postoperative variables as pain or blood loss.~   "
179642|NCT01213589|"~     The purpose of this post-market release registry is to collect additional information~     concerning safety, performance and health economic data with respect to the Medtronic VALIANT~     Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of descending~     thoracic aortic dissections.~   "
179643|NCT01213576|"~     Albendazole and ivermectin are currently used in combination for annual mass treatment of~     lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such~     programmes is very high and has proven to be a major impediment to the success of programmes~     in many countries with limited financial resources.~      Data from albendazole treatment of other filarial infections and one study comparing single~     to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased~     dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae.~     It is essential to determine whether such higher doses are indeed beneficial since this could~     have far-reaching effects on the conduct and management of the main mass treatment programmes~     and also in the management of programmes as they near elimination.~   "
179644|NCT01213563|"~     Gastric bypass surgery has been proposed as an effective treatment strategy for type 2~     diabetes mellitus (T2DM), but thus far algorithms for the management of T2DM immediately~     after surgery have not been established. The investigators designed an algorithm to achieve~     good glycaemic control in patients with insulin-requiring T2DM upon discharge after gastric~     bypass surgery, and evaluated this algorithm for feasibility, efficacy, and safety.~   "
179645|NCT01213550|"~     The aim of this study is to evaluate the therapeutic effectiveness of chlorhexidine~     mouthrinse on gingival inflammation and subgingival microbiota in addition to daily~     mechanical plaque control in a population with established gingivitis.~   "
179646|NCT01213537|"~     This study aims to investigate the effect of a pacemaker device used in heart failure~     patients which is called Cardiac Resynchronisation Therapy (CRT). Specifically the~     investigators aim to investigate if the CRT pacemaker has an effect on breathing stability in~     these patients and particularly breathing stability at night. Our theory is that the CRT~     pacemaker may improve the stability of breathing in patients with heart failure.~   "
179647|NCT01213524|"~     The objective of this study is to investigate the relative contributions of nicotine~     replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on~     abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms,~     cognitive task performance and smoking behavior in smokers with schizophrenia and~     non-psychiatric smokers.~   "
179648|NCT01213511|"~     The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC)~     extracorporeal circulation on neurocognitive function after elective coronary bypass grafting~     (CABG) as well as whether this can be attributed to improved cerebral perfusion~     intraoperatively.~   "
179649|NCT01213498|"~     It has been documented that statin reduce mortality and morbidity in patients with~     cardiovascular disease. This effect can partly be related to a reduction in cholesterol~     levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as~     nephropathy, diabetes and hypertension. The purpose of this study is to investigate the~     effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular~     variables in patients witk chronic kidney disease.~   "
179650|NCT01213485|"~     This observational study will evaluate the course of treatment, the efficacy on anemia and~     the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic~     kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal~     dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating~     agents (ESA). Data will be collected from each patient for 12 months.~   "
179651|NCT01213472|"~     The purpose of this study is to investigate the safety, immunogenicity and clinical activity~     of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of patients~     with non-operable and progressing metastatic cutaneous melanoma.~   "
179652|NCT01213459|"~     This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the~     HPV type distribution among women >= 15 years of age, attending routine gynaecological~     examination in the Kingdom of Saudi Arabia.~   "
179653|NCT01213446|"~     This is an open-label study to investigate the pharmacokinetics (PK), efficacy, and safety of~     a von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, in children with Von Willebrand~     disease (VWD) in whom treatment with a VWF product is required for prophylactic therapy,~     haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic~     bleeding event.~   "
179654|NCT01213433|"~     This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of~     AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.~   "
179655|NCT01213420|"~     This study is a prospective, randomized controlled, double blinded, study in a multi centre~     setting. Three burn centres will include 60 patients in total.~      If suited for the study (= two equal donor sites) and after informed consent, patients will~     be observed starting the day of skin prelevation.~      A coded file will be made for each patient and these files should contain the localization of~     both donor sites, their depth as determined by the setting of the dermatome and the~     treatment. Treatment for both donor sites will always be equal.~      The date of wound healing of each donor site, which may only differ by a maximum of five~     days, will be noted. Digital photographs of the healed donor sites will be taken and the~     scars will be evaluated by the local researchers using the Adapted Vancouver Scar Scale prior~     to the start of hydration.~      From that moment on one donor site will be treated with Aruba Aloe formula F-BC-096 while one~     of the control products will be applied to the second site. Per group of five patients per~     centre a different control product will be applied to the second donor site. The tubes~     containing these products will be colour and numerical coded. Nor the treating personnel, nor~     the patients will be informed which colour tubes contain the control products and which~     contain the Aruba Aloe formula F-BC-096. If it is necessary to apply pressure garments for~     one donor site, the garments will be applied for both sites.~      Follow-Ups will be performed on one, three and six months after wound closure. Objective~     methods will be used during these follow-ups to evaluate elasticity and colour of the scar,~     this by using the Dermalab, the Cutometer®, the Derma Spectrometer and the Mexameter®. The~     evaporation, permeability and hydration of the scar will be measured by using the Tewameter®~     and the Corneometer®. The Reviscometer® will measure the direction of collagen and elastin.~     The Adapted Vancouver Scar Scale will be used as a subjective method. Also different scales~     for evaluation of donor site pain, patient satisfaction, product comfort, itching etc. have~     to be completed by the patient.~   "
179656|NCT01213407|"~     A randomised, open-label, 2-arm, multi-centre, phase II clinical study with one group~     receiving standard therapy with Temozolomide, radiotherapy, and Trivax; and a control group~     receiving standard therapy with Temozolomide and radiotherapy only; after tumour resection of~     at least 70% in both groups. The hypothesis is based on the assumption that time to~     progression will be doubled in the treatment group.~   "
179657|NCT01213394|"~     The purpose of this research study is to determine if adding or increasing the dose of~     CellCept while lowering the dose of tacrolimus (Prograf or Advagraf) or cyclosporine~     (Neoral), and/or steroids can reduce the likelihood of developing coronary heart disease in~     the next 10 years.~      The investigators will calculate the change in risk of developing coronary heart disease~     using the Framingham score. The Framingham score is a mathematical equation that includes the~     following information: Age, Gender, Diabetes status, Smoking status, Lipids, Blood Pressure.~     The Framingham score estimates how likely it is that someone will develop coronary heart~     disease over the next 10 years.~   "
179658|NCT01213381|"~     Primary Objective:~      - To determine a dose of SAR240550 to be further studied in combination with chemotherapy~     regimens~      Secondary Objectives:~        -  To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination~          with chemotherapy regimen (gemcitabine and carboplatin~        -  To assess safety profiles: significant laboratory changes and adverse events (AEs)~        -  To make a preliminary assessment of antitumor effect in study subjects per Response~          Evaluation Criteria in Solid Tumors (RECIST) with measurable disease~        -  To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and~          4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics~        -  To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
179659|NCT01213368|"~     Primary Objective:~      - To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in~     patients with permanent Atrial Fibrillation (AF).~      Secondary Objective:~        -  To assess the safety and tolerability of dronedarone after repeated oral doses of 300~          mg, 400 mg, or 600 mg twice daily in the selected population.~        -  To document SR33589 and SR35021 trough plasma levels at steady state.~   "
179661|NCT01213342|"~     Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease~     is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007),~     the investigators hypothesize that the omega-3 fatty acid supplements used in this study will~     help to improve dry eye signs, such as eye surface irritation (staining) and tear film~     osmolarity, which is an overall measure of tear film stability and dry eye status. Further,~     the investigators hypothesize that dry eye symptoms, the end result of dry eye disease, such~     as discomfort and burning, will also improve with supplementation.~   "
179662|NCT01213329|"~     The purpose of this study is to check the T and B cells of the immune system in 50 newly~     transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100~     anticipated participants). This will be done to see how the Standard of Care (SOC)~     anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H®~     reduces the number of T cells produced by one's body. We will look for these cells using a~     number of laboratory tests; It will require the subjects to each give 65mL of blood at each~     of the 3 visits that occur during phase 1. Up to 12 subjects will be chosen from phase 1 to~     participate in phase 2 depending on lab results.~      In phase 2, subjects will be randomized to one of the three following groups:~      Group one: Continue normal immunosuppression with tacrolimus and Cellcept® (control group)~      Group two: Cellcept® will be tapered down to 70% in three months. Tacrolimus will be~     continued at the same dosage.~      Group three: Tacrolimus will be reduced to 70% in three months. Cellcept® will be continued~     at the same dosage.~      There will be an analysis of these cells at different time point, pre and post kidney~     transplant. The data collection will allow us to study the stability over time of particular~     phenotypes (cell structures) and T cell function. We will also evaluate how the two different~     minimizing protocols effect the cell structure. Results from laboratory testing may allow~     us to define certain criteria that can be broadly applied in solid organ transplant~     recipients. This may allow for safe reduction of the anti-rejection medication that~     transplant recipients receive.~   "
179663|NCT01213316|"~     This is an observational, non-comparative, multicenter, open-label study. Participants will~     be treated with Raltegravir according to standard clinical practice, and monitored over a~     total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging~     participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks.~     Participants who stop taking Raltegravir before the end of the 96-week period or 48-week~     period, respectively, will be followed up for 3 months after discontinuing the drug. The~     primary objective is to determine the proportion of participants with a human~     immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with~     Raltegravir.~   "
179664|NCT01213303|"~     Cardiovascular diseases belong to the major causes of mortality in western populations, and~     atherosclerosis is the lesion responsible for clinical events, such as acute myocardial~     infarction and stroke.~      Atherosclerosis remains asymptomatic until a clinical event occurs, and in the pre-clinical~     stage it may be difficult to diagnose. As disease surrogate, a large number of risk factors~     for atherosclerosis are being recognized. Some of them are responsible for the~     epidemiologically very serious metabolic syndrome, which accounts for development of~     hyperlipidemia, obesity, diabetes or arterial hypertension.~      Health providers in continental diet-based countries suggest to embracing Mediterranean diet~     in order to contribute in reducing cardiovascular mortality. However, countries in the~     Mediterranean area are experiencing a shift in dietary habit towards continental diet with~     potential harmful change in mortality rates. Oxidative stress, including free radical-driven~     reactions and antioxidant status are considered important mediators to be considered in the~     diet-mediated effect on health. Important metabolic functions are also mediated by certain~     fatty acids. A comprehensive study of oxidative stress, including free radical-driven~     products and protective antioxidants, and fatty acids metabolism has never been reported in~     healthy subjects. In particular, high sensitive mass-spectrometry methods to study oxidative~     stress and fatty acids metabolism are rarely applied to epidemiological studies.~      The aim of the present grant project is therefore to assess in a large cross-sectional study~     the prevalence of oxidative stress markers, and fatty acids and to find any causal relation~     between these variables and metabolic syndrome. This population sample will be followed~     prospectively not only for time of the present grant project, but we would like to study~     metabolic variables with relation to the development of oxidative stress-mediated diseases,~     in particular those of cardiovascular system, on a longitudinal basis (prospective~     epidemiological study for at least 10 years). At same time we should be able to define the~     importance of individual markers of oxidative stress and fatty acids for early detection of~     these diseases.~   "
179665|NCT01213290|"~     Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become an important tool in~     the diagnostic evaluation of gastrointestinal tract lesions and other organ sites such as~     mediastinal and intra-abdominal lymphadenopathy, pancreatic masses, liver masses, left~     adrenal masses and gastrointestinal submucosal lesions. It provides crucial information that~     can have tremendous impact on patient management. FNA is typically performed using a 22- or~     25-gauge needle with a stylet under EUS guidance. The lesion is punctured with a stylet in~     place in the needle. After withdrawal of the stylet, the needle is moved to and fro within~     the lesion and this process is repeated for each needle pass. It is currently believed that~     the use of a stylet for EUS-FNA improves the quality of specimens by preventing the tip of~     the needle being clogged up with tissue and hence enhances the diagnostic yield of specimens~     obtained. However, there are no data demonstrating clearly that the use of a stylet improves~     the yield of EUS-FNA. The reason why this question is important is because the use of a~     stylet during EUS-FNA is cumbersome, time and energy consuming and increases the costs of~     EUS-FNA needle systems.~      In this prospective randomized controlled trial, patients referred for EUS-FNA of mediastinal~     and intra-abdominal lymphadenopathy, pancreatic mass, liver mass, left adrenal mass and~     gastrointestinal submucosal tumors will be included. FNA will be performed with a 22-gauge~     needle under EUS guidance using suction with a 10 mL syringe by two experienced~     endosonographers. The technique to be used for fine needle sampling i.e. with a stylet in~     place or without a stylet for each FNA pass will be assigned by using a preprinted~     randomization scheme obtained from a sealed envelope and clearly documented. Each lesion will~     be sampled for a minimum of four needle passes. The pathologists providing the final~     interpretation will be blinded to technique of EUS-FNA (with or without stylet). The degree~     of cellularity, contamination, amount of blood, adequacy of sample, frequency with which a~     positive diagnosis is made will be compared between the two groups (EUS-FNA with stylet vs.~     EUS-FNA without stylet). The sensitivity, specificity, accuracy, positive predictive value~     and negative predictive value of each technique when compared to the final diagnosis will be~     calculated. Inter-observer agreement among cytopathologists will be assessed for specimens~     obtained from EUS-FNA with stylet and for those obtained from EUS-FNA without a stylet.~   "
179666|NCT01213277|"~     HbA1c is used as a gold standard to see whether patients have optimal glycemic control.~     Today, many physicians rely solely on HbA1c to change medication. However, there is a select~     group of patients that have low average glucose levels but high HbA1c levels. The~     investigators believe that these patients are fast glycators meaning that they incorporate~     sugar into their hemoglobin faster than normal. The investigators want to determine whether~     these patients are fast glycators.~   "
179678|NCT01213121|"~     -  To examine differences in neurophysiologic parameters between unmedicated patients with~          bipolar depression and healthy controls~        -  To examine within-subject changes in neurophysiologic parameters in patients with~          bipolar depression treated with quetiapine~   "
179711|NCT01212692|"~     The purpose of this study is to learn if activities that challenge the brain (mentally~     stimulating activities) can improve memory and other types of thinking in patients with Mild~     Cognitive Impairment. The study will compare the effects of different methods of mental~     stimulation.~   "
179667|NCT01213264|"~     The intent of this observational study is to collect prospective data regarding neuromuscular~     monitoring practices and extubation standards (Train-Of-Four [TOF] value) during surgery, in~     countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries).~     Secondarily the study will observe, for which surgical procedures neuromuscular blocking~     agents (NMBAs), and reversal agents to such, are used. This study is a non-interventional~     clinical trial, and administration of NMBAs, and respective reversal agents, (as well as all~     drugs used during anesthesia) will be done in accordance with routine anesthesiology~     practice, and labeling guidelines. Neuromuscular transmission will be monitored according to~     routine anesthesiology practice by means of acceleromyography. The assignment of the~     participant to a particular therapeutic strategy is not decided in advance by a trial~     protocol, but falls within current practice and the prescription of the medicine is clearly~     separated from the decision to include the patient in the study.~   "
179668|NCT01213251|"~     The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent~     adverse remodeling of the myocardium following an acute myocardial infarction (MI) in~     patients at highest risk for adverse myocardial remodeling.~   "
179669|NCT01213238|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to~     patients with advanced cancer that has spread to the liver. The safety of these drug~     combinations will also be studied.~   "
179670|NCT01213225|"~     Nursing home patients admitted to the hospital poses significant challenge for health care~     providers. Geriatric teaching pays particular attention to these admissions and related~     problems. However, it yet to be proven, that geriatric training helps to overcome any of them~     in better way then non-geriatric education. The study aims to prove that geriatric care~     provides advantages over non-geriatric training in caring for nursing home patients admitted~     to the hospital.~   "
179671|NCT01213212|"~     The study investigates whether a caloric restricted dietary regime can prevent onset and/or~     progression of chronic kidney disease in type 2 diabetic patients with abdominal obesity,~     through the amelioration of concomitant metabolic abnormalities such as insulin resistance,~     dyslipidemia, hypertension and inflammation, possible risk factors for the onset of kidney~     disease.~      The main aim of the study is therefore to evaluate the renoprotective effect of caloric~     restriction (CR) on subjects at risk of nephropathy. Secondary aim is to better understand~     how dietary implementation can modulate renal disease and its associated metabolic~     abnormalities.~   "
179672|NCT01213199|"~     The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the~     treatment of atrophic acne scars.~   "
179673|NCT01213186|"~     HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually~     leads to clinically significant immunodeficiency. A chronic generalized immune activation is~     now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1~     immunity and disease progression during chronic HIV-1 infection. However, it is still unknown~     whether reducing immune activation will restore CD4 T cell counts and leading to immune~     reconstitution in chronic HIV infection. Mesenchymal stem cells (MSC) have been demonstrated~     to decrease immune responses of the host, and can suppress inflammation in HIV-infected~     non-responders. Here, the investigators propose a hypothesis that MSC can reduce immune~     activation which subsequently lead to the restoration of CD4 T-cell counts dependent on dose~     of transfused MSCs in HIV-infected patients.~   "
179674|NCT01213173|"~     The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®)~     (95 - 190 mg) on heart rate in the Stable angina patients.~   "
179675|NCT01213160|"~     The primary purpose of this study is to explore the safety and tolerability of AZD4547 in~     Japanese patients with advanced solid malignancies.~   "
179676|NCT01213147|"~     Despite the progression in assisted reproductive technology (ART), the preferred protocol for~     poor responders is still controversial. The management of poor responders consists of 10% of~     ART cycles .~      The response to controlled ovarian hyperstimulation (COH) is lower regarding estradiol level~     , number of obtained oocytes , and fertilization , implantation and pregnancy rates in~     patients with low ovarian reserve . Furthermore , bad quality embryos are observed in these~     women more than normoresponders and the increase of cancellation rate and doses of~     gonadotropin administration are remarkable results in poor responders . Several criteria have~     introduced for poor responders , the main defect in the management of them is lack of~     specific definition .Several strategies are available to improve ART cycles outcome in poor~     responders. These modalities include using : high FSH dose , stop GnRH-agonist protocol ,~     addition of growth hormone , transdermal testosterone , aromatase inhibitor , GnRH-antagonist~     and recombinant FSH ( r-FSH) ; while the improvement of pregnancy rate has been quite low.~      The most common used protocol for ovarian stimulation is microdose GnRH-agonist flare in poor~     responders .Some investigators concluded that the use of GnRH-agonist  even in lower doses ,~     led to prolonged stimulation and increased the cost without improving IVF outcome.~     Furthermore this method increased LH , progesterone and androgen of serum in follicular phase~     , which caused deleterious effect on follicular growth and oocyte quality .~      Clomiphene citrate co-treatment with gonadotropin and antagonist are one of the recommended~     protocol in poor responders . Clomiphene citrate increases endogenous FSH versus agonist in~     microdose protocol. Decreasing the doses of used gonadotropin and duration of stimulation are~     its beneficial effects in COH cycle .~      The aim of this study was comparing CC/gonadotropin/antagonist and GnRH agonist flare~     protocols on IVF outcome in poor responders .~   "
179677|NCT01213134|"~     Portfolios are the records of learning process, providing evidences of experiential learning.~     It can be a valuable tool not only for understanding the learning process but also for~     evaluating the accomplishment. Portfolios promote learners to reflecting, thinking, improving~     in learning as well as achieving learning goals. It has been widely applied in medical~     education. The goals of resident training outcomes in Wan-Fang Hospital are the ACGME six~     core competences. The Wan-Fang hospital, one of Taipei Medical University affiliated~     hospitals and the first implementing portfolio assessment teaching hospitals in Taiwan, will~     conduct portfolio assessment to assess residents competences. Facilitating residents bring~     reflective learning into practice, personal and professional growth and demonstrating the~     outcomes of training program. This study describes initiating and implementing portfolio~     assessment procedures. Qualitative and quantitative research methods are applied for~     evaluating the portfolio assessment process and the data of validity and reliability.~     Qualitative data collection methods of interview, focus groups and meetings will be used~     understanding the experiences and viewpoints of residents, mentors and assessors. Then~     quantitative data collection method of questionnaire will be subsequently used. The results~     of this study will provide experiences and suggestions for the implementation of portfolio~     assessment system in medical education.~   "
180904|NCT01197027|"~     The purpose of this study is to evaluate the acceptability and feasibility of an enhanced,~     individual-level counseling intervention for individuals in the acute and early phase of HIV~     infection aimed at reducing risk behaviors.~   "
179679|NCT01213108|"~     The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of~     13-16 year old youths in regular parental meetings. The program aims to encourage parents to~     maintain a restrictive attitude towards youth drinking throughout their children's teenage~     years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study by~     the program developers showed a sustained alcohol-specific restrictivity among parents~     exposed to the program, and also a reduction on drinking measures among the youths of the~     exposed parents (Koutakis, Stattin & Kerr, 2008). This study aims to investigate whether~     these effects are sustained also when the program has gone into wide dissemination in Sweden.~   "
179680|NCT01213095|"~     The clinical efficacy of rituximab, a chimeric monoclonal antibody targeted toward the B-cell~     specific antigen CD20, was initially demonstrated in cases of follicular lymphoma (FL), but~     the use of this antibody has been extended over the last few years to the majority of~     subtypes of B-cell CD20 positive non-Hodgkin's lymphomas, with promising results thus far. In~     MZL, small numbers of case reports have chronicled the use of rituximab as a single agent or~     phase II trial combination with chemotherapeutic regimens.~      The results of the rituximab maintenance phase III trial demonstrated that patients with FL~     who continued to take rituximab monotherapy as a maintenance therapy after responding to an~     initial course of chemotherapy combined with or without rituximab experienced longer~     progression-free survival durations than did those who received no rituximab maintenance~     therapy. The efficacy of maintenance treatment after first-line induction treatment with~     R-chemotherapy was addressed in the international PRIMA (Primary Rituximab and Maintenance)~     study, which has enrolled 1,217 patients. The first results are eagerly awaited. Although MZL~     has better prognosis in TTP and OS than FL, both of them are classified as the same category~     of indolent lymphoma -characterized by frequent relapse and prolonged survival.~      According to the results of our survey, advanced stage MZL tends to be an indolent disease -~     characterized by prolonged survival with frequent relapses. Rituximab appears to contribute~     to better responses, but not in TTP. Thus, we should consider maintenance treatments for MZL~     patients, to extend their response duration.~   "
179681|NCT01213082|"~     The purpose of this study is to test the hypothesis that proton beam irradiation combined~     with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal~     anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.~   "
179682|NCT01213069|"~     The goal of this study is to evaluate the knowledge of paramedical and medical care personnel~     concerning organ and tissue donations, as well as their opinions on this activity.~   "
179683|NCT01213056|"~     The literature on the efficacy of Cognitive Behavioral Therapy (CBT) for the treatment of~     chronic pain is well established. Support for the efficacy of Mindfulness Based Stress~     Reduction (MBSR) and other mindfulness based treatments for chronic pain is building.~     Recently, research has demonstrated the efficacy of Mindfulness Based Cognitive Therapy~     (MBCT) in simultaneously addressing the outcome variables targeted by both CBT and~     mindfulness based treatment modalities. Although the efficacy of MBCT depression and for~     other populations has been investigated, there is no extant literature reporting on MBCT for~     chronic pain. The current application proposes to investigate the feasibility and efficacy of~     an MBCT protocoll adapted for chronic pain in a series of pilot groups with headache pain~     patients. We selected headache pain patients for this trial because headache pain is a common~     complaint in the general population, is the most frequently reported cause of pain in medical~     practice, and is one of the most disabling conditions for both genders combined. To examine~     the feasibility of the adapted protocol, the investigators will investigate a number of~     treatment related outcomes such as recruitment, completion, and drop out rates. Both primary~     and secondary outcome variables will be investigated to determine treatment efficacy.~      This study will provide a research base examining the feasibility and efficacy of MBCT for~     pain. Results from this study will lay the foundation for future randomized controlled trials~     comparing MBCT to attention control, and future comparative effectiveness studies of MBCT and~     CBT.~   "
179684|NCT01213043|"~     This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of~     Prolastin-C (alpha1-proteinase inhibitor [alpha1-PI] [Human]), compared to weekly infusions~     of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).~   "
179685|NCT01213030|"~     Positron Emission Tomography (PET) with fluorine-18 fluoromisonidazole (FMISO) has been used~     for several years as a non invasive imaging technique to study tumor hypoxia. Several~     experimental and clinical studies have indicated that FMISO uptake of tissues is correlated~     with tissue oxygen tension and that FMSO PET allows non-invasive differentiation between~     hypoxic and normoxic tumors. Currently, FMISO-PET represents the best characterized and~     validated noninvasive hypoxia imaging technique. Nevertheless, clinical studies have also~     shown the limitations of FMISO PET. Accumulation of FMISO in hypoxic tumors is relatively~     low, resulting in a low contrast between hypoxic tumors and surrounding normal tissues. In~     addition, imaging needs to be started relatively late after tracer injection (about 3 hours~     post-injection), when a significant percentage of the fluorine-18 label has already decayed~     and the count statistics of the PET images are relatively low. Because of these limitations,~     FMISO PET is still only used at a few research centers, despite high clinical interest in~     hypoxia imaging.~   "
179686|NCT01213017|"~     The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the~     inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active~     moderate to severe rheumatoid arthritis.~   "
179687|NCT01213004|"~     Tumors must be seen clearly on CT scan to be radiated completely and safely. Breathing causes~     tumors to move. If the tumor moves during breathing, it can look blurred on the CT scan. This~     makes it difficult to see on CT scan. The investigators wish to investigate whether a new~     computer method makes tumors less blurry and easier to see on CT scan. Cone-beam CT is a type~     of CT scanner attached to the radiation treatment machine that produces 3D images of the~     patient. Since your tumor can move because of your normal breathing, it is often blurry and~     difficult to see accurately in a standard cone-beam CT scan. The investigators intend to use~     a computer method which processes the cone-beam CT data in a way that reduces the blurring~     and makes the tumor easier to see.~   "
179688|NCT01212991|"~     The purpose of this study is to determine the benefit of enzalutamide versus placebo as~     assessed by overall survival and progression-free survival in patients with progressive~     metastatic prostate cancer who have failed androgen deprivation therapy but not yet received~     chemotherapy.~   "
179689|NCT01212978|"~     The American Heart Association (AHA) and American College of Sports Medicine (ASCM) recommend~     older adults (50≤ age ≤ 80) perform at least 30 minutes of moderate-intensity aerobic~     exercise on most days ( ≥5 days) of the week. This suggestion arises, in part, from data~     supporting that regular physical activity reduces the risk of adverse cardiovascular events A~     portion of these benefits may be from reductions in the incidence and severity of~     cardiovascular risk factors, including diabetes mellitus, obesity, and hypertension.~      While this recommendation for physical activity has been in existence for almost 15 years,~     the rates of obesity in the United States continue to rise and prevalence of sedentarism~     remains at best unchanged. Researchers have been engaged in investigating novel interventions~     to designed increase physical activity to reach the recommended activity targets. One~     promising intervention involves use of inexpensive, easy to use pedometers that allow~     individuals to objectively track the number of steps taken during a set period of time.~     Recent data suggest that an average of 10,000 steps/day as measured by a pedometer accurately~     estimates the activity levels recommended by the AHA, ASCM, and US government public health~     guidelines.~      While the benefits of habitual exercise are well-documented, there are no data that~     demonstrate current recommendations for moderate physical activity in older adults by the~     ASCM, AHA, and US public health guidelines reduce the risk of adverse cardiovascular events.~     Interestingly, prior work indicates that pedometer-centered interventions can increase~     physical activity, suggesting that this type of intervention could potentially lead to~     cardiovascular benefits. Using validated surrogate markers of cardiovascular risk including~     brachial artery endothelial function, tonometric measurements of vascular stiffness, and~     measurements derived from transthoracic echocardiography, we will determine whether~     increasing the physical activity of sedentary adults to an average of 10,000 steps or~     more/day translates into improvements in cardiovascular health. This will be determined in~     the context of a randomized control trial employing a control group, a study group that uses~     a pedometer alone, and an intervention that couples a pedometer with internet-based~     motivational messaging software demonstrated in our preliminary data to encourage older~     adults to reach and exceed the 10,000 steps/day goal.~   "
179690|NCT01212965|"~     The investigators propose a pilot trial to obtain preliminary information regarding the~     safety and response rate of patients with symptomatic lymphatic malformations treated with~     oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2~     clinical trials.~      Hypotheses:~        -  Selenium will be safe and efficacious in the treatment of adolescents and young adults~          with symptomatic lymphatic malformations~        -  Disease response will correlate with serum levels of selenium and blood levels of~          antioxidants essential to selenium metabolism.~   "
179691|NCT01212952|"~     RATIONALE: Pomalidomide and bortezomib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Bortezomib may also stop the growth of tumor cells by~     blocking blood flow to the tumor. Drugs used in chemotherapy, such as dexamethasone, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving pomalidomide and bortezomib together with dexamethasone may kill~     more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose~     of bortezomib when given together with pomalidomide and dexamethasone and to see how well it~     works in treating patients with relapsed or refractory multiple myeloma.~   "
179692|NCT01212939|"~     When root canals of infected teeth with closed ends are cleaned, disinfected and filled, the~     results are predictable with excellent outcomes. However, in a tooth with incomplete root~     development, the end of the root(s) must be closed before filling the root canals. One or~     two-step artificial barrier using mineral trioxide aggregate (MTA) has been used before~     filling the root canals of these teeth. Despite the high success of this treatment, this~     procedure does not result in complete root formation and these teeth are susceptible to root~     fracture. A number of case reports in scientific journal have shown the possibility for~     regeneration of nerve within the root canal space and continued root development in teeth~     with dead nerves and open ends. There is very little information regarding the use of stem~     cells and growth factors from the blood of patients to regenerate the nerves in these teeth.~     Platelet rich plasma (PRP) from whole blood has been mentioned in the literature as a~     potential ideal material for regeneration of nerves in these teeth. The purpose of this study~     is to investigate the use of PRP to regenerate tooth nerve and close the root ends in teeth~     with root canal infection and open root ends.~   "
179693|NCT01212926|"~     It is now accepted that the anticancer properties of anthracyclines were allowed in many~     malignancies improve the prognosis of affected populations.~      However, the cardiotoxicity of anthracyclines is responsible for an interruption of this~     treatment by alteration of potentially irreversible myocardial contraction and high~     mortality.~      An earlier detection of adverse myocardial anthracycline chemotherapy would allow the~     adaptation of the regimen by reducing the number of interruptions of antitumor and~     strengthening monitoring. Optimizing the therapeutic antitumor and generate an increase in~     survival of patients treated.~   "
179694|NCT01212913|"~     Primary Objective:~      To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between~     the basal plus one and the biphasic insulin regimen.~      Secondary Objective:~      To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to~     comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event~     is taken into account.~   "
179695|NCT01212900|"~     Background:~      - Atherosclerosis (thickening of the artery walls caused by cholesterol and other deposits)~     commonly occurs in the heart vessels and carotid (neck) arteries of adults. This is often~     present in individuals with high cholesterol levels in their blood. These patients are~     usually treated with cholesterol lowering medication ( statins ) along with modification of~     diet and exercise. Researchers are interested in investigating new approaches including~     magnetic resonance imaging (MRI) and computed tomography (CT) imaging studies to detect blood~     vessel blockages that would not otherwise be detected by cholesterol levels and risk factors~     for heart disease.~      Objectives:~      - To measure atherosclerosis in the heart vessels and carotid arteries using imaging tests~     (computed tomography (CT) and magnetic resonance imaging (MRI)) before and after standard~     treatment with cholesterol lowering medication ( statins )~      Eligibility:~      - Healthy individuals at least 55 years of age who are candidates for therapy to lower their~     blood cholesterol levels.~      Design:~        -  This study will involve one screening visit and seven study visits over a period of 2~          years.~        -  Participants will be screened with a physical examination and medical history, as well~          as blood samples and tests to ensure that it is safe for them to have CT and MRI scans.~          Participants will provide information on current medications, dietary habits, smoking~          status, alcohol and caffeine intake, and their level of physical activity.~        -  Participants will be divided into two groups. One group will receive standard doses of~          medication to lower cholesterol according to current treatment guidelines, while the~          other group will have MRI scans of the carotid arteries and a CT scan of the heart to~          determine the best medication dose levels.~        -  Visits 3 to 5 will be scheduled 3, 6, and 9 months after visit 2. During these visits,~          researchers will monitor for possible side effects and may change or adjust medications~          and doses.~        -  At visit 6, participants will have an MRI scan of the carotid arteries, a physical~          examination, and blood tests. Medications may be changed or adjusted.~        -  At visit 7, participants will have blood tests, and medications may be changed or~          adjusted.~        -  At the final visit, participants will have MRI and CT scans of the carotid arteries and~          heart, respectively, as well as a final physical examination and blood tests.~   "
179710|NCT01212705|"~     Sleep disordered breathing is common in patients with chronic heart failure. Adaptive~     servoventilation is a novel method of treatment central sleep apnoea, especially associated~     with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive~     servoventilation on cardiac function, exercise tolerance and quality of life in patients with~     chronic heart failure.~   "
180905|NCT01197014|"~     Study Design :~      - A single center, open, randomized, single dose, two-period, two-treatment, two-sequence,~     crossover study~   "
179696|NCT01212887|"~     RATIONALE: Placing a gene into T cells may improve the body's ability to recognize cancer~     cells and build an immune response to fight cancer. Drugs used in chemotherapy, such as~     cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Biological~     therapies, such as aldesleukin, may stimulate the immune system in different ways and stop~     cancer cells from growing. Giving specially treated T cells together with cyclophosphamide,~     fludarabine phosphate, and aldesleukin may kill more tumor cells.~      PURPOSE: This phase I clinical trial is studying the side effects and best dose of treated T~     cells when given together with cyclophosphamide, fludarabine phosphate, and aldesleukin in~     treating patients with cancer.~   "
179697|NCT01212874|"~     This is an investigator initiated, sponsored, open label, prospective randomized controlled~     trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will~     be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that~     occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary~     bypass (CPB).~   "
179698|NCT01212861|"~     The primary objective of this study is to evaluate the safety, efficacy, and performance of~     the Suprachoroidal Dissection Instrument in creating a fistula between Schlemm's canal and~     the suprachoroidal space in refractory, open angle glaucoma subjects.~   "
179699|NCT01212848|"~     The purpose of this study is to determine whether transcranial magnetic stimulation (TMS) is~     effective in the treatment of suicidal thinking in individuals with a depressive episode and~     either posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (TBI), or~     both conditions.~   "
179700|NCT01212835|"~     Silastic rings have been used around the gastric pouch in order to promote better weight loss~     after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that~     some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The~     investigators hypothesized that the use of a silastic ring may play a role in promoting GERD~     after this operation.~   "
179701|NCT01212822|"~     This pilot phase II trial studies how well giving bevacizumab and combination chemotherapy~     together before surgery works in treating patients with locally advanced esophageal or~     stomach cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Drugs used in~     chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving these~     treatments after surgery may kill any tumor cells that remain after surgery.~   "
179702|NCT01212809|"~     This study is being done to evaluate the differences in the performance of two well known~     injectable dermal fillers commonly used for the cosmetic treatment of age lines above the~     lips and on the cheeks when compared to each other in the same patient. The products being~     tested are Juvéderm® Ultra and CosmoDerm® 1.~   "
179703|NCT01212796|"~     The allogeneic hematopoietic stem cell marrow is the only curative treatment for many~     hematologic malignancies. However, many patients relapse in these situations to be~     therapeutic possibilities scarce and mixed. Chemotherapy in these situations does not show~     good results and new drugs have not yet demonstrated the effectiveness desired.~      Another therapeutic approach after relapse post allogeneic transplant is to resubmit the~     allogeneic transplant patient to patient. In this clinical situation is little known. All~     previous studies are retrospective, the data provided are of little statistical value and~     heterogeneous patient samples.~      The GETH (Grupo Espanol de trasplantes hematopoyeticos y terapia celular) has included in its~     database a figure around 350 seconds allogeneic transplants. Comparing this with the studies~     published so far, this would be the largest retrospective series published size compared to~     second allogeneic transplants.~   "
179704|NCT01212783|"~     The purpose of this study is to determine the efficacy of In-Home Cognitive Behavioral~     Therapy (IH-CBT) in comparison to Present-Centered Therapy (PCT), a supportive therapeutic~     approach. IH-CBT is adapted form of CBT that is provided to depressed mothers participating~     in ongoing home visitation services. IH-CBT has been adapted to fit the setting, population,~     and context associated with home visiting. Mothers are recruited at 4 months postpartum. A~     comprehensive assessment battery is administered at pre-treatment, post-treatment, and 6, 12,~     and 18 months after the end of treatment. It is hypothesized that IH-CBT will be superior to~     PCT in decreasing depression, improving overall functioning, enhancing parenting~     effectiveness, and preventing relapse.~   "
179705|NCT01212770|"~     The purpose of this study is to determine whether apremilast is safe and effective in the~     treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.~      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and~     swollen joints, pain, physical function) in treated patients.~   "
179706|NCT01212757|"~     The purpose of this study is to determine whether apremilast is safe and effective in the~     treatment of patients with psoriatic arthritis.~      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and~     swollen joints, pain, physical function) in treated patients.~   "
179707|NCT01212744|"~     The purpose of this study is to evaluate the effect of daily administration of rAvPAL-PEG on~     the reduction of blood Phe concentrations in subjects with PKU.~   "
179708|NCT01212731|"~     The purpose of this study is to:~        -  estimate the degree of memory loss, if any following radiotherapy to the base of skull~          or brain as measured by standard neurocognitive battery testing.~        -  describe radiotherapy dose-related changes in vascular perfusion, in spectroscopic~          parameters of neuronal injury and changes in the degree and directionality of tissue~          water diffusivity (diffusion tensor imaging) as a measure of white axonal injury.~        -  to relate these imaging characteristics to the degree of memory loss.~   "
179709|NCT01212718|"~     The aim of the study was to evaluate the feasibility of TS determination in a multicenter~     trial setting using a central facility for measurement and confirm its role as predictive~     factor for 5-FU treatment in MCRC.~   "
184188|NCT01153919|"~     RATIONALE: Romiplostim may cause the body to make platelets.~      PURPOSE: This randomized phase II trial is studying how well romiplostim works in treating~     hepatitis C-infected patients with thrombocytopenia.~   "
179712|NCT01212679|"~     Traumatic bain injury(TBI) remains a hidden epidemic involving individuals affected~     predominantly at a young age who in the most severe cases remain with permanent~     physical,psychological and cognitive deficits.This study will investigate the therapeutic~     effects of intranasal Nerve Growth Factor(NGF) in TBI.~   "
179713|NCT01212666|"~     The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo~     when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.~   "
179714|NCT01212653|"~     1. To determine the effect of Golimumab treatment on the number and function of Endothelial~          Progenitor Cells (EPCs) in Ankylosing Spondylitis(AS) patients as a possible mechanism~          for the effect of this treatment on endothelial function.~        2. To ascertain the effect of Golimumab treatment on , carotid intima-media thickness,~          vascular stiffness in Ankylosing Spondylitis(AS) patients as measured by pulse wave~          velocity (PWV) and Augmentation index (AIx).~        3. To assess the clinical efficacy of Golimumab in Chinese Ankylosing Spondylitis(AS)~          patients according to ASAS response criteria at month 3, 6 and 12.~        4. To perform cost-effectiveness and cost-utility analyses of the Golimumab in Ankylosing~          Spondylitis(AS) patients, using clinic-base data.~   "
179715|NCT01212640|"~     OBJETIVES:~        1. To research the worsening of respiratory status risk factors after transfusion in~          spanish critical care units.~        2. To determine the incidence of transfusion-related acute lung injury (TRALI) in~          critically ill patients.~        3. To research the morbi-mortality of TRALI.~   "
179716|NCT01212627|"~     The main purpose of this study is to evaluate the best dose, safety and side effects of~     ridaforolimus when given with cetuximab for patients with head and neck, lung and colon~     cancer that has progressed after initial therapy. A second purpose of this study is to gain~     preliminary information on whether the combination of ridaforolimus and cetuximab is helpful~     in treating patients with advanced head and neck cancer~   "
179717|NCT01212614|"~     This study bases on the successfully completed project SNF 320000-112006 (EK 1152 and~     SwissMedic 2005dr2207e) and will document the physiological effects of inhibited gastric~     secretion on the volume as well as the acidity of gastric secretion by high dose proton pump~     inhibitors in GERD patients and healthy controls. Twelve participants in each group will be~     studied in a randomized, double-blind placebo controlled trial. A novel non-invasive MRI~     technique developed in Zurich will assess the volume of gastric secretion following the~     ingestion of a regular liquid meal. In addition, intragastric / esophageal pH monitoring will~     assess the link between volume and intragastric distribution of gastric secretion on reflux~     events and symptoms. In addition, the effect of gastric secretion on outcome parameters of a~     non-invasive stable isotope breath test for measurement of gastric emptying will be assessed.~   "
179718|NCT01212601|"~     This is a Multicenter, observational, non-interventional registry designed to collect~     clinical data in Chinese patients who have received CUBICIN treatment under condition of~     actual usage in clinical practice.~   "
179719|NCT01212588|"~     Participants will be randomized to either Mifepristone 600mg once daily for seven days or~     Placebo tablet once daily for seven days. Rating scales, vital signs, cortisol levels will be~     collected for evaluation.~   "
179720|NCT01212575|"~     The primary objective of this non-interventional study is to investigate how Seroquel XR and~     Seroquel IR are used in the clinical practice of outpatients with schizophrenia. This will be~     done by a retrospective review of medical records to evaluate patients treated with Seroquel~     XR or Seroquel IR as primary antipsychotic treatment.~   "
179721|NCT01212562|"~     The purpose of this study is to evaluate the efficacy of cryosurgery during continuing~     imiquimod application in the treatment of basal cell carcinoma of the skin.~   "
179722|NCT01212549|"~     To compare the effectiveness of two application schemes of cryosurgery during a 5 week course~     of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod followed by~     3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0 followed by 5 weeks~     of topical imiquimod (cryoimmunotherapy)~   "
179723|NCT01212536|"~     The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope~     with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study~     during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as~     conventional laryngoscopy for tracheal intubation of infants and children. This will be an~     equivalence rather than a non-inferiority study.~   "
179724|NCT01212523|"~     The investigators hypothesize that there is no difference between the effects of isoflurane~     and propofol anaesthesia on pulmonary vascular resistance (PVR).~   "
179725|NCT01212510|"~     The primary purpose of the study is to confirm the results of previous study about the~     usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in~     patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The~     secondary purpose is to evaluate the value of circulating free mutant DNA and circulating~     tumor cells (CTC) and their variations during the treatment.~   "
179726|NCT01212497|"~     Evaluate the effectiveness of using a virtual computer coach to provide mindfulness~     meditation training, and the coaching support required to initiate a regular practice.~   "
179757|NCT01212094|"~     Background:~      - Secondary-progressive multiple sclerosis (SP-MS) is the chronic phase of multiple sclerosis~     (MS). The majority of people who have relapsing-remitting MS eventually develop SP-MS. There~     are currently no effective treatments for SP-MS. Researchers are interested in determining~     whether the drug rituximab, which is used to treat rheumatoid arthritis and some types of~     cancer, is able to target certain white blood cells that are thought to play a role in the~     progression of SP-MS. To ensure that the rituximab will reach the brain and spinal cord,~     participants will receive it by intravenous drip and by intrathecal injection (through a~     lumbar puncture into the cerebrospinal fluid).~      Objectives:~      - To evaluate the safety and effectiveness of combined intravenous and intrathecal rituximab~     in individuals with secondary-progressive multiple sclerosis.~      Eligibility:~      - Individuals between 18 and 65 years of age who have been diagnosed with SP-MS and have been~     off any form of immunosuppressive therapy for at least 3 months.~      Design:~      - The study will involve a 1-year pretreatment baseline series of visits, followed by a~     2-year treatment period. Participants will provide blood samples throughout treatment as~     directed by the study researchers, and additional studies may be performed during the study~     period if participants consent to further investigation.~   "
179727|NCT01212484|"~     This is a pilot clinical trial of carbidopa to treat disabling attacks of nausea and vomiting~     in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary~     sensory and autonomic neuropathy type III). FD is a rare autosomal recessive disease in which~     the growth and development of selective nerves is impaired. Patients with FD suffer recurrent~     uncontrollable nausea and vomiting crises accompanied by skin flushing, tachycardia and~     arterial hypertension. Current treatments of nausea are ineffective or have intolerable side~     sides. Our long-term goal is to treat nausea effectively and without side effects, a~     therapeutic intervention that would markedly improve the quality of life of patients with FD.~      The investigators have recently found that resting plasma dopamine levels are high in~     patients with FD and increase up to 40-fold during nausea and vomiting attacks. This led us~     to postulate that stimulation of dopamine receptors in the chemoreceptor trigger zone of the~     brainstem is the likely mechanism of vomiting.~      Carbidopa is a reversible competitive inhibitor of aromatic L-amino acid decarboxylase (also~     known as dopa-decarboxylase) that cannot cross the blood brain barrier. It has been used~     successfully for many years to block the extracerebral synthesis of dopamine and avoid nausea~     and vomiting in patients with Parkinson's disease taking levodopa. The investigators reasoned~     that carbidopa could have a similar antiemetic effect in patients with FD.~      The investigators propose to conduct a pilot trial to assess the safety, tolerability and~     efficacy of carbidopa for the treatment of nausea in patients with FD. The pilot trial will~     recruit 25 patients with FD who complain of severe nausea that affects their quality of life.~     The trial will be divided into two consecutive, but independent parts. Part 1, will address~     the safety and tolerability of carbidopa in patients with FD using an open-label dose~     titration phase followed by 4-weeks of open-label treatment. Part 2, will address the~     efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized,~     placebo controlled, double blind, 4-week cross over design.~      The investigators hope to demonstrate that carbidopa is a safe, well-tolerated drug that~     blocks the peripheral formation of dopamine and thus prevents dopamine-induced nausea and~     vomiting attacks in patients with FD.~   "
179728|NCT01212471|"~     A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry~     eye disease.~   "
179729|NCT01212458|"~     Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine~     Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung~     moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie~     schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder~     diabetischer Polyneuropathie).~      In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich~     ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal®~     (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt.~     Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der~     Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen~     Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon®~     die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der~     Haut vermindert werden.~        -  Trial with medicinal product~   "
179730|NCT01212445|"~     The primary objective of the study was to evaluate the proportion of subjects with a bowel~     movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of~     treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus~     Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses~     of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported~     BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM~     control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.~      In addition, the proportion of subjects with a BM (without straining and without hard and/or~     lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E~     was evaluated for the time to first BM.~   "
179731|NCT01212432|"~     Daptomycin kinetics in CRRT~        -  Trial with medicinal product~   "
179732|NCT01212419|"~     Objectives: Sleep characteristics have been used for prediction of neuro-developmental~     outcome. The aim of our study was to evaluate the influence of morphine and midazolam on the~     development of SWC in newborns > 32 weeks' gestational age after major non-cardiac surgery.~      Study design: This prospective aEEG study included infants > 32+0 weeks' gestation admitted~     to the Neonatal Intensive Care Unit at The Royal Children's Hospital in Melbourne who were~     undergoing major non-cardiac surgery. The BrainZ Monitor (BRM2, Version 8.0, BrainZ~     Instruments, New Zealand) was applied post-operatively. The time of onset and quality of SWC~     and the maximum levels of morphine and midazolam as predictors of time to SWC were then~     assessed.~      Results: Forty-seven eligible infants were included. Emergence of SWC was observed at a mean~     of 13 hours post-surgery. The maximum dose of morphine or midazolam was not predictive of~     time to SWC.~      Conclusions: Despite high doses of continuous infusions of morphine and midazolam SWC was~     observed on aEEG in neonates > 32 weeks' gestational age soon after major non-cardiac~     surgery. The main type of aEEG background pattern was not affected by the maximum dose of~     either morphine or midazolam. Abnormalities in aEEG in post-surgical patients are not always~     drug related.~   "
179733|NCT01212406|"~     Vitamin D deficiency occurs in around 50% of our transplant population. Preventive treatment~     with Vitamin D (D-cure) can reduce the prevalence of Bronchiolitis Obliterans Syndrome after~     lung transplantation~   "
179734|NCT01212393|"~     The appropriate use of thromboprophylaxis in medical patients admitted to hospital can~     substantially reduce the overall burden of disease due to venous thromboembolism. However,~     the use of thromboprophylaxis in medical setting appears to be generally poor leaving at-risk~     patients unprotected.~      We aim to analyse the incidence of symptomatic thromboembolic disease following~     hospitalisation in medical setting and the efficacy of a multicomponent prevention approach~     in emergency department including systematic evaluation of thrombosis risk factors and~     remembers of thrombophylaxis indications and modalities for acutely ill medical patients.~      Design: cluster randomized interventional study - Observational study at patient level~      Setting: 30 French emergency departments~      Patients: Patients over 40 years old admitted in participating emergency departments and~     hospitalized for acute medical reasons.~      Main judgment criteria: the rate of symptomatic thromboembolic events and severe haemorrhage~     during a formal 3-months follow-up after hospital admission in patients hospitalized at least~     48 hours.~   "
179735|NCT01212380|"~     RATIONALE:~      Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~      PURPOSE:~      This phase I trial is studying the side effects and the best dose of carfilzomib in treating~     patients with relapsed or refractory chronic lymphocytic leukemia(CLL),small lymphocytic~     lymphoma(SLL), or prolymphocytic leukemia (PLL).~   "
179736|NCT01212367|"~     This research will study how to activate the immune system by using gene transfer. Gene~     transfer involves inserting a specially designed gene into cancer cells. A gene is a part of~     the genetic code that instructs the cells of our bodies to produce specific compounds~     (proteins) important for the makeup or function of the cell. The study hypothesis is that~     repeated doses of SCH 721015 given over a three day interval would result in gene transfer.~   "
179737|NCT01212354|"~     The major clinical problem and predominant cause of death after radio-oncological treatment~     of H+N cancers are loco-regional relapses. This randomized trial tests the hypothesis that~     dose escalated Intensity Modulated Radiotherapy (IMRT) selectively applied to the macroscopic~     primary tumor and involved neck nodes - which both in 80% - are hypoxic improves~     loco-regional control by at least 15% at 2 years. IMRT is combined with concurrent Cis-Platin~     chemotherapy. Tumor volume which correlates with number of malignant cells as well as tumor~     hypoxia are important biological parameters which increase radio-resistance, failure of local~     control and tumor progression. Basing on data of experimental and clinical radiation oncology~     we consider hypoxia as a useful parameter for pre-therapeutic strati-fication in future~     randomized radio-chemotherapy trials.~      In addition, hypoxia imaging by PET can be used for testing the significance of selective~     dose escalation on hypoxic tumor sub-volumes (Dose Painting).~      As a prerequisite for such innovative studies addressing hypoxia the translational part~     investigates the following key issues: correlation between the size of total tumor volume~     (primary, lymph nodes) and hypoxic sub-volume, the spatial shift of the hypoxic sub-volume~     before start of treatment and the correlation of loco-regional control and hypoxia.~      Before starting the main study a pre-study to assess the occurrence of radiation induced~     toxicities is mandatory to be performed. In a step-wise dose-escalation in a cohort-design~     the safety of dose-escalation should be determined. Step one: 6 patients Step two: 14~     patients. In the pre-study the 1st group (6 patients) should be treated with 2.2 Gy up to~     77.0 Gy for DEVPT and DEVLK. After evaluation of the toxicity the next 14 patients should be~     treated by this scheme.~   "
179738|NCT01212341|"~     Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who~     underwent leukapheresis. These cells were processed based on a novel method for ex vivo~     activation and expansion using an irradiated and activated autologous feeder cell system.~     MG4101 has anti-tumor activities against various tumors including malignant lymphomas in~     vitro as well as in vivo tumor model.~   "
179739|NCT01212328|"~     Background: Cardiovascular diseases (CVD) are currently the leading cause of death globally~     and Asian Indians will account for between 40-60% of the global CVD burden within the next~     10-15 years. Risk factor control and preventive care are effective in reducing CVD events and~     mortality. The greatest gains in CVD prevention have been seen when early and target-driven~     interventions address multiple risk factors together. However, achieving control of even~     individual risk factors (blood glucose, blood pressure, or blood lipid targets) is poor,~     globally. Quality improvement schemes, like the proposed intervention, have shown promise in~     high-income countries, but are untested in South Asia; a region with a population at~     extraordinarily high CVD risk.~      Objective: To test whether a clinic-based case management intervention (consisting of~     guidelines based treatment, care coordinator assistance and decision support software) to~     reduce cardiovascular disease (CVD) risk among Type 2 diabetes patients in South Asia, is~     more effective and sustainable compared to existing care.~      Trial subjects and methods: The study will involve a total of 1120 patients attending 8~     established out-patient clinics in South Asia (140 patients at each clinic). Patients~     enrolled in the trial will be randomly assigned to either the control (existing care) or the~     intervention group and will be followed up for an average of 30 months. The total trial~     duration is about 3.5 years, from mid-August 2010 to December 31, 2013.~   "
179740|NCT01212315|"~     The purpose of this study is to assess if triclosan-coated sutures reduces wound infections~     after saphenous vein harvesting in CABG patients. Secondary objectives are the effect~     triclosan-coated sutures on sternal wound infections and a cost analysis.~   "
179741|NCT01212302|"~     Dual antiplatelet therapy with acetylsalicylic acid (ASA, aspirin) and clopidogrel is of~     great importance for treatment following coronary stenting. Unfortunately the variable~     platelet inhibitory effectiveness compromises the antithrombotic benefit of dual antiplatelet~     therapy. The aim of this prospective single centre study was to reduce the low response~     incidence of dual antiplatelet therapy with ASA and clopidogrel based on a standardized~     therapy algorithm.~   "
179742|NCT01212289|"~     Cardiac surgery requiring use of a heart-lung machine, also known as cardiopulmonary bypass~     (CPB) can induce abnormalities in blood coagulation (clotting) that lead to excessive blood~     loss during and after operation. While of significant concern in adults, this problem takes~     on even greater importance in children due to the simple fact that they have a smaller blood~     volume. It is well known that if a child has previously undergone a heart operation, they are~     at increased risk of bleeding should more cardiac surgery be required (reoperation). The~     processes regulating blood coagulation are extraordinarily complex, and little is known about~     the exact mechanisms that contribute to the increased bleeding associated with cardiac~     reoperation in children. Rotational thromboelastometry (ROTEM®) is a technology that can~     provide, at the bedside, detailed information about coagulation abnormalities. While not~     currently approved for general use in the United States, in Europe ROTEM® has been used to~     guide administration of the blood products in surgery based upon determination of specific~     coagulation abnormalities. Importantly, there is now evidence that guidelines for transfusion~     therapy based on ROTEM® reduce transfusion requirements thus decreasing patient exposure to~     blood products. Whether the use of ROTEM® has potential benefit for pediatric cardiac~     surgical patients has not been studied. Accordingly, the present study was designed to~     provide preliminary data comparing coagulation profiles between children undergoing cardiac~     reoperation to those having primary procedure.~      The investigators hypothesize that ROTEM® analysis will detect a pattern of impaired~     coagulation in children undergoing reoperation. The overall objective of the four assays of~     ROTEM® analysis therefore, is to provide information that can be used to devise a rational~     transfusion protocol for pediatric cardiac surgical subjects.~   "
179743|NCT01212276|"~     The purpose of this study is to evaluate whether therapy with MORAb-028 is safe, effective,~     and to determine the appropriate dose of MORAb-028 in the treatment of metastatic melanoma.~   "
179744|NCT01212263|"~     To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene~     citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation~     rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better~     pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary~     FSH in these cases.~   "
179745|NCT01212250|"~     Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled.~     After baseline evaluation, the participants will be randomized to receive either Placebo or~     Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.~   "
179772|NCT01211899|"~     Data on 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1) gene are limited in~     Asian patients with sepsis. Therefore, the investigators aim to prospectively investigate the~     incidence of 4G/5G polymorphism and its relationship with disseminated intravascluar~     coagulatin in patients with severe sepsis and septic shock.~   "
179746|NCT01212237|"~     Normal tissue response is critical for brain radiotherapy, especially for dose escalation~     which carries with it an increased incidence of radiation-induced brain injury. Although~     radiation toxicity and limiting dose for anatomically critical structures of the brain have~     been well studied and documented, little is known for functionally critical brain regions and~     treatment of cognitive sequelae of cranial radiotherapy is limited. The objective of this~     clinical protocol is to accumulate preliminary data for future studies aiming to quantify~     dose response for functionally critical brain regions for brain radiotherapy. We plan to~     achieve this objective by correlating the radiation-induced complications and radiological~     changes with the radiation dose to the selected functionally critical brain regions for 25~     patients. Each participating patient will receive brain fMRI to identify brain regions for~     processing visual, working memory and language functions. The image co-registration algorithm~     developed previously by our group will be used to co-register these regions on the CT scans~     for radiotherapy treatment planning for radiation dose calculation. Radiation-induced changes~     in cognitive functions will be evaluated using the modified mini mental status exam (3MS) and~     fMRI during the routine follow-up. The knowledge derived from this study might significantly~     improve the quality of life and allow safer dose escalation for patients receiving brain~     radiotherapy.~   "
179747|NCT01212224|"~     This is a confirmation of safety profile for Minirin Melt in clinical practice.~   "
179748|NCT01212211|"~     Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently,~     association between hyponatremia and bone fractures in the ambulatory elderly has been shown.~      Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention~     deficit.~      Symptoms related to hyponatremia can be very subtle and difficult to detect clinically.~     Twenty elderly patients, retirement homes residents, with serum sodium < 135mEq/L will be~     included. They will be randomised. The physician will review the drug treatment of ten~     patients in coordination with the opinion of pharmacologists. Drug treatment for ten other~     patients wil remained unchanged during the three months of inclusion.~      Useful elements of the medical records of patients randomized to the experimental arm will be~     forwarded to the Pharmacovigilance Regional Center for opinion pharmacologist. The notice,~     subject to the attention of physician of retirement homes, give rise to a therapeutic~     approach towards the patient. It will be followed by weekly monitoring of serum sodium for 4~     weeks to evaluate the impact of the intervention. Thus, the effectiveness of medical~     intervention will be evaluated by an objective biological criteria: serum sodium in the~     fourth week. Secondary endpoints will evaluate the duration of normalization of serum sodium~     and check the interest of correcting hyponatremia to improve postural capacities and~     eventually reduce the number of falls in the medium term (three months).~   "
179749|NCT01212198|"~     This is an observational study done by creating a cohort of Korean patients with diabetes and~     those at high risk of developing diabetes. By the creation of this cohort we aim to establish~     efficient preventive, diagnostic, and therapeutic measures based on the characteristics of~     Korean patients with diabetes, and by doing so, we hope to ultimately decrease our country's~     diabetes-related-mortality and increase the quality of life of patients with type 2 diabetes.~   "
179750|NCT01212185|"~     Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective~     in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring~     standard medication treatment (lorazepam) and the amount of lorazepam required to control~     withdrawal bouts in individuals undergoing medical detoxification. Also, determine rates of~     subject recruitment and retention in the inpatient setting.~      Participants: 80 alcohol dependent patients, 18-65 years of age, admitted for medical~     detoxification.~      Procedures (methods): Subjects will be inpatients undergoing medical detoxification from~     alcohol. Oxytocin or placebo will be administered in a nasal spray twice daily in a~     randomized, double blind manner for three days. Withdrawal symptoms will be measured~     routinely at q4 hours and prn for length of hospital stay. Lorazepam will be given whenever~     withdrawal symptoms increase above specific parameters.~   "
179751|NCT01212172|"~     The purpose of this research study is to compare two different 810 diode laser systems~     (Soprano XL (SHR Mode)and Light Sheer Duet) for laser hair removal. The goal is to determine~     if each laser system is effective at reducing the amount of hair on the lower legs or the~     axilla (arm pit). Another goal is determine the subject's perspective on the treatment~     including tolerability and effectiveness.~   "
179752|NCT01212159|"~     The purpose of the study is to demonstrate that systematic self measurement of blood lipids~     reduces LDL cholesterol more effectively than standard care. The hypothesis is that~     cholesterol lowering medication adherence will be improved with self monitoring and reporting~     of frequent blood lipids and the percentage of patients achieving LDL goal will be greater~     than without home monitoring.~   "
179753|NCT01212146|"~     The aim of the present randomized double-blind controlled crossover study is to compare the~     effects of the 15-day consumption of artichokes enriched with the probiotic Lactobacillus~     paracasei LMGP22043 with those of ordinary artichokes on treatment preference, satisfactory~     relief of symptoms, bowel habit and the modulation of SCFA production in a group of patients~     suffering from functional constipation.~   "
179754|NCT01212133|"~     This study is conducted in Asia. The aim of this study is to evaluate the safety and~     effectiveness of liraglutide in subjects with type 2 diabetes mellitus.~   "
179755|NCT01212120|"~     The presence of S aureus in the nasal passages of diabetic patients may be a risk factor for~     diabetic foot lesion infections. Our aim is to compare the genetic profiles of S aureus~     strains found in the noses and on the foot lesions of diabetic patients. The investigators~     are also studying the virulence of these strains, the prevalance of S aureus at either site,~     and whether or not the quantity of S aureus found in the nose affects the risk for infection~     in foot lesions. The investigators also use this study to test the sensitivity and~     specificity of the GeneXpert system.~   "
179756|NCT01212107|"~     The study is to determine the recommended Phase 2 regimen of study drug that may be safely~     administered to patients with advanced and or metastatic cancer. The study consists of two~     parts: a dose escalation and a dose confirmation.~   "
180051|NCT01208246|"~     The purpose of this study is to understand the effect of the pregnancy on the muscles in the~     pelvis. The purpose of this study is to evaluate the pelvic muscle changes related to~     pregnancy; to assess if the ability to squeeze and relax these muscles has any effect on~     delivery mode and if there are any injuries to the pelvic muscles.~   "
179758|NCT01212081|"~     Background:~      - Individuals with schizophrenia or schizoaffective disorders have a high prevalence of~     cannabis use. Understanding some of the environmental factors that maintain cannabis use,~     such as socially triggered cravings, is a critical step in improving treatment for cannabis~     dependence. In recent years, virtual reality has been studied to determine whether it can be~     used to induce craving by using life-like cue settings. Researchers are interested in using~     virtual reality systems to study cannabis cravings in individuals with schizophrenia.~      Objectives:~      - To determine if virtual reality cues will elicit cannabis craving in persons with~     schizophrenia who have a history of cannabis use.~      Eligibility:~      - Individuals between 18 and 50 years of age who have been diagnosed with schizophrenia or~     schizoaffective disorders, are on a stable antipsychotic medication, and who have a lifetime~     history of at least 50 cannabis uses and average cannabis use of once per month.~      Design:~        -  This study involves an initial screening visit, a study visit, and a followup visit.~        -  Participants will be screened with a medical history and physical examination, and will~          complete questionnaires about their history of marijuana and other drug use.~          Participants will also learn how to use the virtual reality equipment at this visit.~        -  During the study visit, participants will respond to marijuana cues using the virtual~          reality system while researchers monitor their heart rate, blood pressure, and sweat~          levels.~        -  At the followup visit, participants will complete questionnaires about their mood and~          any cravings for marijuana.~   "
179759|NCT01212068|"~     Background:~        -  People with epilepsy often have auditory processing disorders that affect their ability~          to hear clearly and may cause problems with understanding speech and other kinds of~          verbal communication. Researchers are interested in developing better ways of studying~          what parts of the brain are affected by hearing disorders and epilepsy, and they need~          better clinical tests to measure how individuals process sound. These tests will allow~          researchers to examine and evaluate the effects of epilepsy and related disorders on~          speech and communication.~        -  A procedure called a magnetoencephalography (MEG) can be used to measure the electrical~          currents involved in brain activity. Researchers are interested in learning whether MEG~          can be used to detect differences in the processing of simple sounds in patients with~          epilepsy, both with and without hearing impairments.~      Objectives:~      - To measure brain activity in hearing impaired persons with epilepsy and compare the results~     with those from people with normal hearing and epilepsy as well as people with normal hearing~     and no epilepsy. This research is performed in collaboration with Johns Hopkins Hospital and~     epilepsy patients must be candidates for surgery at Johns Hopkins.~      Eligibility:~        -  Individuals between 18 to 55 years of age who (1) have epilepsy and have hearing~          impairments, (2) have epilepsy but do not have hearing impairments, or (3) are healthy~          volunteers who have neither epilepsy nor hearing impairments.~        -  Participants with epilepsy must have developed seizures after 10 years of age, and must~          be candidates for grid implantation surgery at Johns Hopkins Hospital..~      Design:~        -  This study will require one visit of approximately 4 to 6 hours.~        -  Participants will be screened with a full physical examination and medical history,~          along with a basic hearing test.~        -  Participants will have a magnetic resonance imaging (MRI) scan of the brain, followed by~          a MEG scan to record magnetic field changes produced by brain activity.~        -  During MEG recording, participants will be asked to listen to various sounds and make~          simple responses (pressing a button, moving your hand or speaking) in response to sounds~          heard through earphones. The MEG procedure should take between 1 and 2 hours.~        -  Treatment at NIH is not provided as part of this protocol.~   "
179760|NCT01212055|"~     Background:~      - Gene therapy is being investigated as a possible treatment for individuals with~     immunodeficiency diseases or other conditions that make it difficult to fight off infection.~     Gene therapy avoids problems with donor identification and possible rejection of bone marrow~     transplant by using the patient s own modified blood cells to help treat the disease.~     Researchers are interested in collecting stem cells from the blood of individuals with~     immunodeficiency diseases in order to use the cells to develop potential gene therapy~     treatments.~      Objectives:~      - To collect blood stem cells from patients with immunodeficiency diseases tto test our~     ability to correct the defects of these cells in the test tube. .~      Eligibility:~        -  Individuals between 18 and 40 years of age with immunodeficiency diseases.~        -  Individuals with human immunodeficiency virus (HIV) will not be able to participate in~          this study.~      Design:~        -  Participants will provide an initial blood sample for disease screening (such as~          hepatitis B and C, syphilis, or viruses like the Epstein-Barr virus, herpes simplex~          virus, or toxoplasmosis) and to check kidney and liver function.~        -  Starting 5 days before blood donation, participants will receive daily injections of a~          drug called G-CSF (granulocyte colony stimulating factor, or filgrastim), which pushes~          stem cells out of the bone marrow and into the bloodstream. Participants will receive~          the injections at the National Institutes of Health Clinical Center.~        -  On day 5, participants will have a single leukapheresis procedure to collect the stem~          cells from the blood.~        -  No additional treatment will be provided as part of this protocol. The cells that are~          collected will be used fore experiments in the lab and will not be used to treat~          individuals with these diseases.~   "
179761|NCT01212042|"~     Respiratory infections have a high associated morbidity and mortality, especially in~     immunocompromised patients. To initiate effective treatment of respiratory infections, it is~     essential that a rapid and thorough laboratory analysis of respiratory specimens be~     performed, given the wide range of pulmonary pathogens that can be detected in this~     population. Conventional microbiology is time-consuming and cumbersome, and the capability of~     local laboratories to assess specimens for rare or unusual pathogens is often limited. This~     study will evaluate if a newer technology can be effectively utilized in the identification~     of a broader range of infectious agents relative to conventional procedures.~      Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased~     operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical~     specimen. The technology has had limited clinical application, but early studies have shown~     its effectiveness in accurately identifying a large number of viral and bacterial organisms.~     In contrast to conventional microbiological procedures based on phenotypic traits (growth~     characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to~     detect and identify the species, serotype/subtype, or strain of the infectious agent.~      Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage,~     BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be~     analyzed using the customized microarray chip. The specimens will be collected as part of the~     patients routine clinical care. The results of the TessArray microarray analysis will not be~     available to the clinician and therefore will not have any effect on the clinical care of the~     patients.~      The results of the microarray analysis from each site will be compared to that site s~     clinical laboratory results, and the data will be analyzed by site.~   "
179762|NCT01212029|"~     Background:~      - Non-invasive functional near infrared (fNIR) imaging techniques use infrared light to~     detect changes in blood volume and oxygen levels during brain activity. fNIR is being studied~     as a possible way to examine the brain activity of individuals who are unable to undergo~     standard brain function imaging techniques (such as functional magnetic resonance imaging, or~     fMRI). For instance, war veterans who have iron shrapnel in the body are not able to have~     fMRI scans, and very young children or children with autism and related disorders are often~     not able or willing to cooperate long enough in the MRI environment to allow full imaging~     studies to take place. Researchers are interested in comparing the results of fNIR and fMRI~     performed on healthy volunteers to determine if fNIR produces similarly accurate results.~      Objectives:~      - To examine the capabilities of non-invasive functional near infrared imaging techniques on~     healthy volunteers and compare the results with the existing outcomes of functional magnetic~     resonance imaging.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will have one study visit. Depending on the complexity of the task, the~          whole exam will take between 5 minutes and 1 hour to perform.~        -  Participants will be asked to sit as still as possible while wearing a headband that~          includes light sources and detectors (the fNIR device).~        -  Participants will be asked to perform a set of tasks (e.g., reading sentences or~          counting numbers in one s head). Data will be collected during these experiments.~   "
179763|NCT01212016|"~     Background:~      - Food allergies are characterized by abnormal immune system responses to certain foods, such~     as peanuts, strawberries, and shellfish. Some individuals with these allergies have immediate~     allergic reactions on contact with the food in question and need immediate treatment to~     prevent severe complications. In contrast, eosinophil-associated gastrointestinal disorders~     are related disorders in which white blood cells in the intestinal tract react to certain~     foods, causing abdominal pain, nausea, and other digestion problems. Researchers are~     interested in studying these conditions to better understand how the immune system responds~     to food allergies.~      Objectives:~        -  To examine how the immune system responds to food allergens.~        -  To examine how certain white blood cells contribute to disease in individuals with food~          allergies and other inflammatory diseases.~      Eligibility:~        -  Individuals between 18 and 65 years of age who have a history of (a) severe allergic~          reaction to peanuts (and have peanut-specific antibodies), (b) allergy or inflammatory~          disease, or (c) eosinophil-associated gastrointestinal disorder (with at least two~          documented food allergies).~        -  Healthy volunteers between 18 and 65 years of age who have no known allergies or asthma.~      Design:~        -  All participants will have a screening visit and a procedure visit. The procedure visit~          will take place within 30 to 60 days of the screening visit, and will take 3 to 4 hours~          depending on the procedure(s) done.~        -  Participants will be screened with a physical examination and medical history, and will~          provide blood samples for testing. Participants with peanut or other allergies will have~          additional tests to determine their levels of sensitivity to certain foods. Participants~          with eosinophil-associated gastrointestinal disorder will provide stool samples for~          testing.~        -  At the procedure visit, participants with peanut allergies and participants with other~          allergies will provide blood samples and have leukapherisis to collect white blood cells~          for examination.~        -  At the procedure visit, healthy volunteers and participants with eosinophil-associated~          gastrointestinal disorder will provide blood samples and have leukapherisis to collect~          white blood cells for examination. In addition, some but not all of these participants~          will have a procedure called esophagogastroduodenoscopy (EGD), which will examine the~          esophagus, stomach, and small intestine. Participants who are scheduled to have EGD will~          be asked to fast for 6 hours before the procedure.~   "
179764|NCT01212003|"~     Background:~      - Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. However,~     most clinical studies of individuals with TB take place at international sites because there~     are many fewer cases of TB in the United States than elsewhere in the world. To provide~     better training for infectious disease staff members at the National Institutes of Health~     Clinical Center in Washington, D.C., researchers are interested in actively recruiting~     individuals with TB for research and treatment studies.~      Objectives:~        -  To provide staff at the National Institutes of Health Clinical Center with increased~          experience in hands-on treatment of individuals with tuberculosis, including~          drug-sensitive or drug-resistant forms of the disease.~        -  To collect blood and other samples to study the natural history of tuberculosis.~      Eligibility:~      - Individuals 2 years of age and older who have either active or latent tuberculosis.~      Design:~        -  Latent TB patients: Participants will have a single study visit with a physical~          examination and medical history, and will provide blood samples for testing.~        -  Active TB patients: Participants will have an initial visit with a physical examination~          and medical history, and will provide blood samples for testing. Participants will also~          provide sputum samples if required, and may have an optional skin punch biopsy to~          collect a sample of skin tissue for study.~        -  Treatment for active TB will be provided as part of this protocol.~        -  Active TB participants will return for study visits every 2 months while receiving~          treatment, and will return every 6 months for 1 year after the end of treatment.~          Participants may be asked to return more often if researchers determine that additional~          care is needed to treat the infection.~   "
179765|NCT01211990|"~     Background:~      - State-of-the art care for children with cancer or rare diseases is not available in all~     countries. Owing to the proximity of Latin America and the growing numbers of Latinos already~     in the United States, many international patients receiving specialized medical care in U.S.~     hospitals are from Spanish-speaking countries. Although there are benefits associated with~     obtaining specialized care in the United States, linguistic barriers and cultural differences~     as well as the general stresses of caring for a child with a serious illness may affect~     families ability to obtain adequate care for their children. Researchers are interested in~     exploring the experiences and needs of international Latino families receiving medical care~     for their child in the United States in order to help health care centers provide more~     appropriate resources and improve the overall quality of culturally sensitive care.~      Objectives:~      - To understand the experiences of international Latino families who are receiving treatment~     for their child or have enrolled their child in a research study in the United States.~      Eligibility:~        -  Caregivers of a child between birth and 25 years of ages who are from Latin America~          (which includes Mexico, all countries in Central America and South America, and~          Spanish-speaking Caribbean countries) and who have traveled to the United States to~          enroll their child in a research protocol and/or seek treatment for their child s~          medical condition.~        -  Caregivers must have a child enrolled on a research protocol at the time of this study.~        -  Caregivers must have been away from their country of origin for a minimum of 3 months.~      Design:~        -  This study requires a single interview that should take approximately 1 hour.~        -  Participants will complete the interview with a member of the research team who is~          bilingual or fluent in Spanish.~        -  Participants will be asked open-ended questions about why they chose to come to the~          United States, how they are adjusting to living and getting medical care for their child~          in the United States, and what hopes they have for treatment outcomes and future medical~          care.~        -  Researchers will record the interviews to be reviewed later. The recordings will be used~          for this study only.~   "
179766|NCT01211977|"~     Background:~        -  Autoinflammatory diseases are illnesses that produce episodes of inflammation such as~          fever, rash, or joint swelling. Some of these diseases can be treated with medications~          that block the body's reaction to a protein called IL-1, which may be part of the cause~          of the inflammation. IL-1 blocking agents are very helpful in treating autoinflammatory~          diseases and have become the standard of care for treatment for some of these diseases.~          However, more research is needed on related diseases that may be treated with new and~          currently used IL-1 blocking agents.~        -  XOMA 052 is an experimental drug that is currently being tested as a possible treatment~          for type 2 diabetes. Initial studies have shown that XOMA 052 neutralizes a specific~          kind of IL-1, and is also active against certain indicators of inflammation. Researchers~          are interested in determining whether XOMA 052 can be used to treat autoinflammatory and~          related diseases.~      Objectives:~      - To determine the effectiveness of XOMA 052 as a treatment for inflammation in adults with~     the autoinflammatory diseases Familial Cold Autoinflammatory Syndrome (FCAS)/Muckle-Wells~     Syndrome (MWS) and Behcet's Disease.~      Eligibility:~        -  FCAS/ MWS: Individuals at least 18 years of age who have a known history of the typical~          disease.~        -  Behcet's Disease: Individuals at least 18 years of age who have evidence of active~          disease, such as oral or genital ulcers or eye disease.~      Design:~      FCAS/MWS Participants~        -  Participants will have an overnight evaluation of their disease, including optional~          tests (e.g., eye or skin exams). Participants who currently take medications to treat~          their symptoms will stop taking the medication and will be monitored by study~          researchers. At the first flare of symptoms, participants will begin to receive XOMA~          052.~        -  Participants will have further tests on days 3, 7, and 10 after the initial dose of XOMA~          052. If the disease remains under good control, participants will have a clinical exam~          every 5 days for up to 10 weeks until another disease flare occurs (determined either by~          symptoms or by inflammation observed in laboratory studies). If the disease is not well~          controlled with the initial dose of XOMA 052, participants will have additional doses~          starting at day 7 until either the disease is controlled or researchers determine that~          the medication is not effective.~        -  Participants will have the option to continue XOMA 052 treatments for up to 1 year. XOMA~          052 wil...~   "
179767|NCT01211964|"~     The purpose of this phase 1 study is to determine the relative bioavailability and~     pharmacokinetics following single oral dose administration of LEO 22811 solution compared to~     LEO 22811 tablet in healthy male subjects as well as to determine the effect of food on the~     single oral dose pharmacokinetics of LEO 22811 tablet in healthy male subjects.~   "
179768|NCT01211951|"~     The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to~     placebo in patients with dry eye syndromes.~   "
179769|NCT01211938|"~     Patients will be randomised after surgery, provided surgery is macroscopically adequate, that~     there is a flap of tissue protecting the vascular axis and that wound healing allows~     reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two~     arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour~     bed + a safety margin of < 2 cm with immediate protection of bone marrow. This volume should~     be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be~     delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the~     investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation~     and at 6 months from randomization (first follow-up consultation)~   "
179770|NCT01211925|"~     Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible~     peripheral arterial occlusive disease.~   "
179771|NCT01211912|"~     This study has two aims:~        1. to evaluate placental transfer of acetaminophen from mother to baby transplacentally~          given from 30 minutes to 24 hours prior to cesarean delivery (34 patients)~        2. to understand the impact of maternal acetaminophen use on fetal movement and breathing~          (20 patients)~   "
179773|NCT01211886|"~     Admission BNP was a useful marker for diagnosing and predicting type IV cardio-renal syndrome~     type IV in patients with chronic kidney disease admitted to the ICU for acute heart failure~     in a retrospective study. Therefore, we aim to prospectively investigate the utility of serum~     BNP in evaluating the treatment adequacy and predicting future cardiac events in patients~     with type IV CRS.~   "
179774|NCT01211873|"~     The purpose of this study is to look at the safety (what are the side effects)and efficacy~     (how well does it work) of Dotarem® when used in taking images of the brain / spine. The~     results will be compared to the results of MRI taken without Dotarem.~   "
179775|NCT01211860|"~     Once a day oral administration with DCCR is the optimal dosing regimen~   "
179776|NCT01211847|"~     Once a day oral administration with DCCR helps lower triglycerides~   "
179777|NCT01211834|"~     The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in~     combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in~     patients with moderate to severe active RA and inadequate response to current DMARD treatment~   "
179778|NCT01211821|"~     The purpose of the study is to assess the effects of BMS-914392 administration on the~     pharmacokinetics of a single-dose of metoprolol in healthy subjects.~   "
179779|NCT01211808|"~     The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of~     single-dose BMS-914392 in healthy subjects.~   "
179780|NCT01211795|"~     Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been~     shown to prevent migraines when used once daily for 3 months in open label studies. This is a~     randomized, double-blind, placebo controlled phase III prevention trial to determine safety~     and efficacy.~   "
179781|NCT01211782|"~     The study will evaluate the safety & efficacy of AC-1204, a ketogenic compound, administered~     orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study,~     subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be~     evaluated by standard tests of memory and cognition, along with other measurements of~     activities of daily living and quality of life. Safety will be assessed by frequency of~     adverse events and changes in laboratory test results. Subjects will be stratified and~     outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).~   "
179782|NCT01211769|"~     Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some~     studies have shown that alcohol alters the environment of the membranes, mainly by modifying~     their permeability through the lipid fraction. These lipids are known as essential fatty~     acids (EFA) because they are obtained only through the diet, as the human body is unable to~     synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3,~     are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and~     metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.~      Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol~     dependent patients.~   "
179783|NCT01211756|"~     The objective of the study is to compare the efficacy of intranasal oxytocin versus~     intranasal placebo to improve depression symptoms in patients with Major Depressive Disorder~     (MDD) or Dysthymia Disorder.~   "
179784|NCT01211743|"~     Study of Oxidative Stress Markers in order to assess whether there are differences between~     standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated~     cholelithiasis~   "
179785|NCT01211730|"~     Many but not all studies have shown improvement in morbidity and mortality with intensive~     glycemic management postoperatively. In this study, the investigators propose to determine~     whether improved glycemic control using intensive insulin treatment immediately~     postoperatively will improve outcomes in patients undergoing liver transplant using a~     prospective, controlled, randomized, parallel-group study design targeting two different~     glucose levels, 140 and 180 mg/dL.~   "
179786|NCT01211717|"~     The purpose of this study is to determine the effectiveness of the 3 Branched Chained Amino~     Acids (isoleucine, leucine, and valine) on treating Delayed Onset Muscle Soreness, a type of~     muscle pain which usually develops after exercising.~   "
179787|NCT01211704|"~     The primary specific aim is to examine the efficacy of Paliperidone extended release~     Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) compared to placebo in decreasing manic~     symptoms in patients with comorbid DSM-IV bipolar disorder and alcohol dependence. The~     investigators hypothesize that the Paliperidone Palmitate Injection (INVEGA® SUSTENNA™)~     treated group will have a statistically significant advantage on improvement in manic~     symptoms. They will also have higher rate of treatment response and remission.~   "
179788|NCT01211691|"~     This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose~     Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004 will~     be administered by IV infusion once weekly as part of a 21-day dosing cycle.~   "
179789|NCT01211678|"~     The primary objective of this study was to validate the ability of an 8-gene biomarker set to~     differentiate between participants who met or did not meet European League Against Rheumatism~     (EULAR) Disease Activity Score (DAS)-28 Good Response criteria after treatment with~     anti-Tumor Necrosis Factor (TNF) therapy for 14 weeks in approximately 200 anti-TNF-naïve~     participants. The secondary objectives of this study was (i) to compare the behavior of the~     8-gene marker set in participants who were anti-TNF naïve versus those who began their second~     anti-TNF treatment , (ii) to develop, maintain, and utilize a biorepository of serum, plasma,~     RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses and~     (iii) to discover novel genetic (DNA) predictors of response to anti-TNF therapy.~   "
179802|NCT01211509|"~     Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality~     and morbidity after lung transplantation. Because montelukast has been shown to be of some~     efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow transplantation),~     the investigators would like to test if montelukast can indeed slow down the progression of~     chronic rejection after lung transplantation.~   "
179834|NCT01211093|"~     Whole body vibration has been found to be useful in promoting bone health, balance, and~     muscle performance in older adults. The overall aim of the proposed study is to determine~     whether whole body vibration (WBV) has immediate beneficial effect in neuromotor performance~     in patients with stroke. It is hypothesized that a single session of WBV will induce~     significant improvement in leg muscle strength in people with chronic stroke.~   "
179790|NCT01211665|"~     The objectives of this study are to explore the effects of administering high-dose~     corticosteroids to participants who developed progressive multifocal leukoencephalopathy~     (PML) while on natalizumab as measured by time-course change in functional status based on~     Karnofsky Performance Status Index through 6 months following the completion of plasma~     exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or~     equivalent), and incidence and severity of adverse events (AEs) and serious adverse events~     (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS)~     as measured by time course changes in Global Clinical Impression of Improvement (GCI-I),~     Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI),~     magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John~     Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize~     the time course elimination of serum natalizumab concentrations in the study population~     following the last PLEX (or equivalent) procedure.~   "
179791|NCT01211652|"~     The purpose of this study is to assess in general population NSAID and gastroprotective agent~     utilization and compliance in elderly people.~   "
179792|NCT01211639|"~     The purpose of this study is to explore host genetic mutations which may render individual~     subjects more susceptible (or resistant) to developing Progressive Multifocal~     Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid~     (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide~     information about viral genotypes that may be associated with higher pathogenicity, and help~     to identify individuals who may be at higher risk of developing Progressive Multifocal~     Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus~     (JCV).~   "
179793|NCT01211626|"~     The overall study design includes two parts, Part A and Part B.~      Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40~     evaluable healthy volunteers were enrolled in Part A of the study.~      Part B evaluated ANA773 following oral administration to patients with chronic HCV infection.~     A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.~   "
179794|NCT01211613|"~     The investigators will be comparing the effectiveness of two types of chiropractic~     manipulation and standard medical care for patients with a recent onset of low back pain. The~     two types of chiropractic treatments being compared will be hands-on (manual) manipulation~     and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a~     medical examination and prescription for over-the-counter anti-inflammatory medication.~   "
179795|NCT01211600|"~     To determine whether the rate of wound complications differs based on method of closure of~     skin incision (staples vs. suture) after cesarean delivery.~   "
179796|NCT01211587|"~     The purpose of this research trial is to determine if safinamide (experimental drug) can~     improve cognition in cognitively impaired but non-demented Parkinson's disease patients. The~     word experimental means the trial drug is not approved by Health Authorities (government~     authorities) and is still being tested for safety and effectiveness.~      Approximately one hundred (100) patients will participate in this research trial. The~     research trial will be conducted in approximately thirty (30) medical centers in the~     following countries: Argentina, Canada, Italy, Peru, South Africa, Spain and USA. The~     research trial will last until June 2012.~   "
179797|NCT01211574|"~     Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or~     Professionals. The aim of this study is to examine the feasibility and preliminary efficacy~     of health coaching for weight loss.~   "
179798|NCT01211561|"~     Selenium's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years,~     but has never been directly studied in humans. The investigators will directly assess~     selenium's ability to prevent CRC by measuring alterations in aberrant crypt foci (ACF), an~     accepted surrogate marker for CRC.~      ACF's are very small (i.e., microscopic) collections of abnormally shaped cells that are a~     commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that~     allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like~     polyps or cancers, but can disappear as a person's risk for developing CRC decreases.~      The investigators propose giving patient's with 6 or more ACF's 200 mcg selenized yeast or~     placebo, and determining if there is a drug-dependant decrease in ACF number. The primary~     objective is to determine whether selenized yeast supplementation, compared to placebo,~     causes significant reduction of ACF number from baseline levels. The primary endpoint will be~     change in ACF number~   "
179799|NCT01211548|"~     This proposal is for the pilot study that will inform the conduct of a larger prospective~     randomized controlled trial to guide perioperative work up and the cost/utility of CTCA (high~     definition CT coronary angiography.)~   "
179800|NCT01211535|"~     The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact~     lens wearers.~   "
179801|NCT01211522|"~     The long-term objective of the MIND-USA (Modifying the Impact of ICU-Induced Neurological~     Dysfunction-USA) Study is to define the role of antipsychotics in the management of delirium~     in vulnerable critically ill patients. We and others have shown that delirium is an~     independent predictor of more death, longer stay, higher cost, and long-term cognitive~     impairment often commensurate with moderate dementia. The rapidly expanding aging ICU~     population is especially vulnerable to develop delirium, with 7 of 10 medical and surgical~     ICU patients developing this organ dysfunction. Antipsychotics are the first-line~     pharmacological agents recommended to treat delirium, and over the past 30 years they gained~     widespread use in hospitalized patients globally prior to adequate testing of efficacy and~     safety for this indication. Haloperidol, the most commonly chosen antipsychotic, is used by~     over 80% of ICU doctors for delirium, while atypical antipsychotics are prescribed by 40%.~     Antipsychotics safety concerns include lethal cardiac arrhythmias, extrapyramidal symptoms,~     and the highly publicized increased mortality associated with their use in non-ICU geriatric~     populations. The overarching hypothesis is that administration of typical and atypical~     antipsychotics—haloperidol and ziprasidone, in this case—to critically ill patients with~     delirium will improve short- and long-term clinical outcomes, including days alive without~     acute brain dysfunction (referred to as delirium/coma-free days or DCFDs) over a 14-day~     period; 30-day, 90-day, and 1-year survival; ICU length of stay; incidence, severity, and/or~     duration of long-term neuropsychological dysfunction; and quality of life at 90-day and~     1-year. To test these hypotheses, the MIND-USA Study will be a multi-center, double-blind,~     randomized, placebo-controlled investigation in 561 critically ill, delirious~     medical/surgical ICU patients who are (a) on mechanical ventilation or non-invasive positive~     pressure ventilation or (b) in shock on vasopressors. In each group (haloperidol,~     ziprasidone, and placebo), 187 patients will be enrolled and treated until delirium has~     resolved for 48 hours or to 14 days (whichever occurs first) and followed for 1 year.~   "
180118|NCT01207362|"~     The purpose of this study is to compare current standing balance assessment methods to a new~     method that measures weight shift during small movements of a sliding platform. It will also~     be used to determine if balance improves with repeated exposure as part of a 4-week training~     program.~   "
179803|NCT01211496|"~     We are exploring a unique weight-training program for men and women 65 years or older that~     emphasizes high speed training. We believe that the speed at which muscles move may be more~     important to the performance of functional tasks than how strong the muscles are. We are~     comparing velocity training with traditional strength training to determine which method has~     the greatest effects on muscle strength, speed of movement, functional performance and~     physical disability. We believe that higher speed training will improve these measures to a~     greater extent than simply training for increased muscle strength.~      Aging also results in loss of bone mass, which increases the risk for falls and fractures.~     Strength training also has been shown to maintain bone mass in the elderly, but no studies~     have examined high velocity resistance training and maintenance of bone mass. We believe it~     is important to examine this aspect of velocity training before recommendations can be made.~   "
179804|NCT01211483|"~     This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving.~     Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding~     U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who~     fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they~     are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287.~      The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve~     survival in subjects with advanced non-small cell lung cancer who failed the first treatment.~   "
179805|NCT01211470|"~     The study investigates the safety and efficacy of PMX-30063 in patients treated for acute~     bacterial skin and skin-structure infection (ABSSSI).~   "
179806|NCT01211457|"~     This is an open label, phase I/II study to evaluate the safety and efficacy of sapacitabine~     administered in alternating cycles with decitabine in elderly patients with newly diagnosed~     Acute Myeloid Leukemia (AML).~   "
179807|NCT01211444|"~     The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the~     Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help~     maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).~   "
179808|NCT01211431|"~     The goal is to compare the quality of post-cesarean analgesia, the side effects and the~     incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or~     with a continuous intra-wound solution including both ropivacain and diclofenac (experimental~     treatment).~   "
179809|NCT01211418|"~     Cocaine addiction continues to be a major problem in the U.S. with no FDA-approved~     pharmaceutical therapy. Finding effective treatment for cocaine addiction has long been a~     challenge to scientists and clinicians. Psychosocial interventions known as behavior~     therapies are the cornerstone of cocaine addiction treatment. However, there is an urgent~     need to further improve treatment outcomes, especially during early recovery and the~     protracted withdrawal phase of the treatment since many patients drop out or relapse during~     this phase. Our clinical experience and studies suggest that integrative Meditation (IM)~     helps reduce cravings and withdrawal symptoms and increases treatment retention. The benefit~     of IM is well supported by tension-reduction theory and attention-networks framework in~     addiction treatment. The proposed study will implement a therapy development study to add IM~     as a self-care component to the current outpatient treatment of cocaine addiction to improve~     treatment outcomes.~      The specific aims of the proposed study include: 1) to conduct a 12-week controlled trial~     with outpatient cocaine users to assess feasibility of recruiting and retaining cocaine~     addicts and to determine effect size of IM-augmented treatment in comparison with~     Nondirective Therapy (NT) control, with both groups receiving standard outpatient treatment~     as usual (TAU), thereby facilitating future larger scale therapy development study; and 2) to~     examine the changes in attention networks and negative mood as possible mediators of~     treatment outcomes between the two groups.~   "
179810|NCT01211405|"~     This study is designed to provide information on whether psychotherapy (talk therapy)~     combined with the drug MDMA is safe and helpful for subjects with posttraumatic stress~     disorder (PTSD). The study will compare the effects of a low, a medium and a full dose of~     MDMA on symptoms of PTSD in 24 veterans, firefighters or police officers. MDMA dose will be~     assigned at random, and the investigators and the subject will not know the dose given. The~     researchers will also investigate depression symptoms. The researchers believe that the full~     dose of MDMA will produce a greater reduction in PTSD symptoms than the two lower doses.~   "
179811|NCT01211392|"~     Prospective study where magnetic resonance imaging is compared to dual-energy computed~     tomography for the detection of bone marrow changes.~   "
179812|NCT01211379|"~     The investigators overall goals are to adapt, implement, evaluate, and disseminate the~     FLU-FOBT Program as an integrated nurse-run, primary care-based intervention that can reduce~     colorectal cancer screening disparities in resource-poor clinical settings. In this program,~     fecal occult blood tests (FOBT) are provided with influenza vaccinations (FLU) to eligible~     patients between the ages of 50 and 75 during FLU season. The investigators hypothesis is~     that the FLU-FOBT Program can be adapted for primary care settings and lead to higher rates~     of colorectal cancer screening (CRCS).~   "
179813|NCT01211366|"~     Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be~     performed safely without increased risk of bleeding or release of inflammatory mediators.~     This will reduce the need for allogeneic blood products as well as crystalloid and colloid~     infusions and thus decrease the length of ventilation and intensive care duration for these~     infants.~   "
179814|NCT01211353|"~     The objective of this research is to better understand how to reduce hazardous drinking among~     OEF/OIF veterans by assessing the effectiveness of a low-cost, computer-delivered~     preventative program.~   "
179815|NCT01211340|"~     The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this~     project is to implement and test this promising intervention in three hospice programs. The~     mixed methods evaluation of this randomized controlled trial (RCT) will provide~     evidence-based data for a tested intervention manual that hospice staff members can use to~     integrate the intervention into their practices.~   "
179902|NCT01210209|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer and their~     relatives may help doctors learn more about changes that occur in DNA and identify biomarkers~     related to cancer.~      PURPOSE: This research study is looking at blood samples collected from patients with Ewing~     sarcoma and their relatives.~   "
179816|NCT01211327|"~     Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory~     disease of unknown cause. It is a fairly common disease in hot, dry environments,~     representing as much as 3% of severe ophthalmic diseases and up to 33% of all eye pathology~     seen among young patients in eye clinics in Central Africa. Symptoms and signs can persist~     for years with an important visual morbidity and social impact. Corneal changes (e.g. corneal~     ulcers) can be sight threatening, occurring in up to 10% of VKC children. Topical steroid~     therapy remains the current standard treatment, but in developing countries its use often is~     chronic and not medically supervised, potentially leading to bacterial infections,~     steroid-induced glaucoma and cataract. Chromoglycate drops have less side effects but lack~     the power to control a flare-up. Topical cyclosporine has the potential to offer an efficient~     but safer alternative to steroid drops in the management of VKC in an African setting. Its~     safety and efficiency in the management of vernal keratoconjunctivitis have been described in~     several uncontrolled studies and double-blind, placebo-controlled trials, but those studies~     were relatively small and involved populations outside Africa with predominantly palpebral~     and mixed forms of VKC. Controversy still remains on the efficiency of cyclosporine in severe~     forms of allergic conjunctivitis like VKC. We therefore undertake a larger prospective~     randomized double-masked, standard treatment controlled clinical trial in Central Africa to~     compare the short-term efficiency of cyclosporine A (CsA) 2% eye drops, solved in olive oil~     vehicle, with that of steroid drops in predominantly limbal forms of VKC. During 4 weeks the~     participants will be randomised to either cyclosporine or dexamethasone as attack treatment~     for VKC. The 4 weeks thereafter all participants will receive chromoglycate drops as~     maintenance treatment. Additional objectives are to document any difference in rebound~     phenomenon while on chromoglycate during the maintenance phase between the 2 treatment groups~     and to evaluate safety and tolerance of the test medication.~   "
179817|NCT01211314|"~     Treatment and control of hypertension is still insufficient. About 50% of the patients remain~     uncontrolled. Lack of compliance with discontinuation of drug treatment is an important~     reason for not achieving blood pressure. Several studies have shown that use of fixed~     combinations improve compliance significantly, by reducing the number of pill's intake.~      This study will assess the antihypertensive efficacy of Vasodip-Combo 20® [enalapril 20 mg +~     lercanidipine 10 mg] as a fixed combination drug in uncontrolled antihypertensive patients.~   "
179818|NCT01211301|"~     The purpose of this study is to compare the effectiveness of the Medifast 5 & 1 Plan to a~     food-based, reduced-energy diet plan. The study will be conducted over 52 weeks, including a~     26-week weight-loss phase and a 26-week weight-maintenance phase. 120 participants will be~     enrolled, with 60 randomized to the Medifast 5 & 1 Plan and 60 randomized to food-based,~     reduced-energy diet plan. Multiple measures will be performed at baseline, 26 weeks, and 52~     weeks, including anthropometry, body composition, blood pressure, blood assays, and appetite~     sensations.~   "
179819|NCT01211288|"~     The purpose is to place implants in HIV positive and HIV negative patients, follow patients~     over 3 years period of time, to evaluate how well dental implants perform in HIV-positive~     patients versus HIV-negative patients.~   "
179820|NCT01211275|"~     The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis~     inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients~     with mesothelioma~   "
179821|NCT01211262|"~     IMCgp100 is a new biological therapy designed for the treatment of melanoma skin cancer. The~     drug is designed to target melanoma cells and stimulate immune cells to kill them. This trial~     is designed to establish the level of drug that can be given to a patient that is tolerable.~     It also designed to establish the best dosing schedule for the drug and to look for signals~     that the drug is working as intended.~   "
179822|NCT01211249|"~     Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment~     with methotrexate will receive once daily two capsules containing either GLPG0259 (25~     mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will~     be examined for severity of disease, as well as for any adverse effects that may occur. If~     needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg.~      Part B: If results of Part A suggest test medication to have a therapeutic advantage over~     placebo and to be well-tolerated, more patients will be recruited for Part B, where various~     dosages will be assessed. These dosages will be established based on results from Part A.~   "
179823|NCT01211236|"~     The main objective of the trial was to study the efficacy of bagged larvae on wound~     debridement in comparison to classical treatments. The secondary outcome was to assess wound~     healing, treatment related pain, microbiological modifications, adverse events, comfort of~     the dressing and duration of wound care. We performed a randomized, double-blind,~     multicenter, controlled, prospective phase III trial in three referral institutional centers~     of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a~     non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index~     (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´~     hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged~     larvae twice a week) or classical treatments (mechanical debridement and classical dressings~     performed three times a week). At discharge, classical dressings were applied and a follow-up~     visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin~     percentage on wounds treated with MDT and classical treatments at D15. The percentages of~     fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems,~     British Columbia, Canada), which enables the quantification of color surface variations in a~     wound after manual delimitation (using a mouse) on a series of photographic images.~   "
179824|NCT01211223|"~     • Background: Peridontitis is a group of diseases with complex bacterial etiology that~     affects a large proportion of the Chilean and worldwide population. Its treatment, based on~     an anti-infective mechanical therapy including scaling and root planning procedures, has been~     highly effective in numerous short and long term clinical trials. The use of adjunctive~     systemic antibiotics has shown significant improvements in the initial therapy results of~     specific periodontal disease types or patient profiles.~      The synergic combination of Metronidazole plus amoxicillin has been widely and successfully~     used for the treatment of aggressive and severe chronic periodontitis, demonstrating~     additional benefits in clinical and microbiological parameters over scaling and root planning~     alone. However, and despite its proven efficacy, there is a lack of evidence that evaluates~     the impact of antimicrobials intake at different times of the mechanical treatment,~     emphasizing the necessity of a study that compares, simultaneously, the variation of the~     adjunctive antibiotic effects when they are administered in different moments through the~     periodontal therapy course.~   "
179903|NCT01210196|"~     To detect early signs of cardiac and metabolic alterations as well as to evaluate the~     progression of cardiac and metabolic impairments in mildly affected patients with Fabry~     Disease using high sensitive diagnostic methods.~   "
179825|NCT01211210|"~     RATIONALE: Preoperative 5-Fu based chemoradiation has become standard treatment for stage 2/3~     rectal cancer. However whether these patients, especially T3N0-1M0 patients, really need~     radiation for local control after total mesentery excision being applied in routine practice~     is still unknown. And whether new drugs adding in can achieve better local and distant~     control is worth investigating.~      PURPOSE: This randomized phase II trial is studying 5Fu based radiation therapy or FOLFOX~     based radiation or FOLFOX alone, comparing them to see how well they work when given before~     surgery in treating patients with intermediate risk resectable rectal cancer. It is not yet~     known whether 5-Fu based or FOLFOX based radiation therapy or even FOLFOX alone is more~     effective in treating rectal cancer.~   "
179826|NCT01211197|"~     The objective of the current study is to determine the relative bioavailability of a BI 10773~     / metformin fixed dose combination tablet compared to single tablets of BI 10773 and~     metformin when administered together and to assess the effect of food on the bioavailability~     the fixed dose combination tablet~   "
179827|NCT01211184|"~     The purpose of this study is to determine whether fluid or glucose administration before hip~     replacement surgery minimizes postoperative muscle breakdown (catabolism), fatigue and~     disturbances in carbohydrate metabolism.~   "
179828|NCT01211171|"~     In the light of ONTARGET and TRANSCEND studies results, it would be interesting to~     investigate the real-life telmisartan treatment tolerability. It is well known and accepted~     that the Real-life setting is much more adequate to reflect the antihypertensive and safety~     properties of the drug in comparison to the organized and scheduled setting of the clinical~     trial. Because there are not much data on the cough in relation to telmisartan, therefore it~     would we worth to observe the cough frequency and general treatment tolerance in patients~     treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.~   "
179829|NCT01211158|"~     When patients come to the Emergency Department with injuries and infections they often need~     to have painful procedures performed that are essential to allowing them to recover. To~     accomplish this, doctors often use procedural sedation. This involves giving medications~     through an intravenous line in order to relieve the patient's pain and to make them drowsy~     while the painful procedure is being performed. This allows the medical staff to perform~     necessary procedures to patients without causing pain and anguish.~      There are several types of medications and combinations of medications that are used for~     procedural sedation. Each medication has its advantages and its disadvantages. Consequently,~     research is necessary to determine which medication or combination of medications is the most~     effective and the safest. This study will compare the use of one drug (Propofol) versus the~     use of a combination of Propofol with another drug (Ketamine). Both of these drugs are~     already used for procedural sedations in the emergency department but it is not known which~     of them is the best or the safest.~      The investigators believe that the combination of ketamine and propofol together will work as~     good or better than propofol alone and be a safer option as well. Propofol is a well known~     sedative that is used in many emergency departments and the clinical experience with it has~     been very good because it acts quickly and wears off quickly. However, propofol is not a good~     pain-killer and it can also cause patients to stop breathing. This is why monitoring a~     patient's breathing and vital signs is essential for any procedural sedation. It is known~     that ketamine is a good pain-killer and helps patients to maintain their breathing. Doctors~     sometimes use ketamine alone for procedural sedation but patients take a very long time to~     wake up when ketamine only is used.~      Thus, the investigators think that by combining ketamine with propofol the investigators can~     perform painful procedures using procedural sedation without causing patients to stop~     breathing as often as with propofol alone. Also, the ketamine the investigators use will help~     treat their pain and make them more comfortable.~      The investigators plan to enroll 284 patients over the course of about one year. The primary~     outcome of adverse respiratory events, as well as the secondary outcomes will be assessed~     during the course of the sedation and recovery period, approximately one hour. Quality of~     life score and pain will be assessed by telephone interview 3 days after the procedure.~   "
179830|NCT01211145|"~     The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age~     12-17 years) with migraine headaches feel better. This will be done by comparing 3 different~     doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).~   "
179831|NCT01211132|"~     This simple technique of attaching a transparent cap to the tip of the colonoscope has been~     evaluated in Japan for improving the detection of polyps and cecal intubation but has not~     been formally evaluated in the US and other western countries. In one study (19), the polyp~     detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04).~     Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a~     recently published study, a variation of the cap called the transparent retractable extension~     device was used (21). Overall, the number of adenomas detected were significantly higher with~     the device compared to without it (205 vs. 150, p=0.04). In an earlier study by Tada et al~     (22), use of a transparent cap improved the detection rate of lesions per patient (0.86 vs.~     0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used cap~     assisted colonoscopy in patients with difficult colonoscopy procedure (defined as failure to~     pass through sigmoid colon after 20 minutes or failure to reach cecum). Using the cap, cecal~     intubation was achieved in 94% of patients and this proved to be an effective rescue method~     for failed or difficult colonoscopy. The major appeal of this technique is that it is~     inexpensive, very practical, and easy to use. Furthermore it is safe and there are no~     reported complications from this. If found to be effective in increasing the polyp yield it~     has the potential to being incorporated by busy gastroenterologists in their day to day~     clinical practice. These features and the preliminary data from Japan merit the evaluation of~     this promising technique in the US.~   "
179832|NCT01211119|"~     Currently, most knee meniscal tears are treated by partial or complete meniscectomy, or by~     suture repair when it is possible. Recently, the investigators have successfully developed~     and implanted a novel biomaterial, platelet-rich fibrin (PRF), to treat articular cartilage~     defect in pigs. The PRF is autogenesis as a natural fibrin-based biomaterial favorable to the~     development of microvascularization and enables local and progressive delivery of growth~     factors providing unique properties for tissue remodeling and wound healing. The advantages~     of using PRF implantation include no transplant rejection and no need to perform second~     operation. Knee meniscal repair using PRF has not been reported before. The aim of this study~     is to investigate whether PRF implantation can facilitate regeneration process of~     meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal~     tears.~      A total of 18 adult patients with torn menisci (outer 1/3, posterior horn, medial meniscus)~     will be recruited and randomly divided into three groups: A (n=6), implantation of PRF after~     partial menisectomy; B (n=6), implantation of PRF after partial menisectomy and suture; C~     (n=6), partial menisectomy only. All studied knee will be scanned on a 1.5-T MRI with surface~     coil at baseline before surgery, 3 months and 6 months and 12 months after surgery.~      The investigators believe that PRF enables to facilitate regeneration of meniscectomized~     knee, and T2-map MRI enables monitoring healing process of meniscal tears.~   "
179833|NCT01211106|"~     The investigators are examining different treatment strategies of helping patients with PTSD~     and addiction.~   "
179835|NCT01211080|"~     Propranolol use for infancy hemangiomas is of world wide interest due to low cost and~     presumed efficacy. The investigators hypothesized that the drug ist highly active against~     growing hemangiomas in problematic sites and that there are little side effects.~      This observational study was undertaken in an uncontrolled fashion to determine sample size,~     design and and tools for a later randomized controlled trial on propranolol versus physical~     therapy (i.e.cryotherapy) which is the most prevalent treatment for the condition. During~     this initial series side effects and relevant design aspects became evident which warrant~     expedited reporting.~   "
179836|NCT01211067|"~     The histology of the internal inguinal ring in patients with indirect hernia submitted to~     elective surgery was studied. In contrast with recently published studies, the investigators~     believe that histological findings of the internal inguinal ring would reflect those~     associated and expected with normal aging.~   "
179837|NCT01211054|"~     Aim: To evaluate the spirometric data and the prevalence of chronic airway disease in old~     population (> 60 yrs) in Korea.~      List to do~        1. History taking~        2. physical examination~        3. Routine blood test~        4. All spirometric data~        5. In subgroup: further evaluation of allergic airway disease~   "
179838|NCT01211041|"~     Candida albicans is the most common and important clinical fungal pathogen. Our previous~     surveillance disclosed that fluconazole could induce different morphological changes in~     clinical strains. Our current study on C. albicans causing candiuria disclosed that renal~     insufficiency , diabetes mellitus, respiratory failure and uremia were risk factors of~     treatment failure. However, we also found results of E-test drug susceptible test could not~     predict outcome. Hence, retrospective analysis of 31 months period, cases that had C.~     albicans inducing candidemia were reviewed and 60 cases were enrolled for morphological study~     and potential virulent gene analysis.~      This study is designed to clarity the clinical meaning of morphological form and virulent~     genes on candidemia. To do this study is probably helpful for treatment of candidiasis.~   "
179839|NCT01211028|"~     The main purpose of this study is to evaluate the safety and feasibility of regenerative~     therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in~     patients with critical leg ischemia.~   "
179840|NCT01211015|"~     Aim: To investigate whether ER stress is implicated in the pathogenesis of various pulmonary~     disorders~      Measurement:~        1. Unfolded protein responses (UPRs) in blood (PBMCs)of patients~             1. CHOP~             2. GRP 78 and so on~        2. Unfolded protein responses (UPRs) in blood (PBMCs)of healthy controls~             1. CHOP~             2. GRP 78 and so on~   "
179841|NCT01211002|"~     It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with~     recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B)~     non-small cell lung cancer.~   "
179842|NCT01210989|"~     Nonalcoholic fatty liver disease is one of the most common chronic liver diseases worldwide.~     Nonalcoholic steatohepatitis (NASH) is the active form of the disease which runs a~     progressive course and may result in liver cirrhosis and liver cancer. However, there is yet~     proven treatment for this disorder. In cell line and animal studies, we have shown that~     Phyllanthus urinaria can ameliorate NASH by reducing oxidative stress and lipid accumulation.~     Phyllanthus (Hepaguard) has been used widely by patients with chronic liver diseases, but the~     efficacy in NASH has not been confirmed in humans.~      This study is divided into two parts. In part 1, 60 patients with histology-confirmed NASH~     will be randomized to receive Hepaguard or placebo for 24 weeks to test the efficacy.~     Endpoints will be assessed at week 24. The aim of part 2 is to test the durability of~     Hepaguard. Forty patients originally on Hepaguard will be randomized again to continue~     Hepaguard for another 24 weeks or stop the treatment. The endpoints at week 48 will be~     further analyzed.~   "
179843|NCT01210976|"~     Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass~     grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to~     describe the haemodynamic effects of levosimendan in comparison to placebo in patients~     undergoing elective aortic valve replacement (AVR) together with coronary artery bypass~     grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will~     be carried out in Heart Center.~      Twenty four patients will be randomized into two groups of 12. The treatment group will~     receive 24 hour infusion of levosimendan preoperatively where as the placebo group will~     receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be~     measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn,~     Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate,~     cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and~     extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be~     carried out as in standard care. Echo cardiography will be done pre- and postoperatively.~     Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24~     hours.~   "
179844|NCT01210963|"~     Investigation of the occurrence of possible corneal swelling after continuous Intraocular~     pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.~   "
179845|NCT01210950|"~     Limb-length discrepancy can be due to many causes. These are divided into three groups:~     congenital (from birth), developmental (from a childhood disease or injury that slows or~     damages the growth plates), and posttraumatic (from a fracture that leads to shortening of~     the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe~     lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift~     greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in),~     shortening of the long leg can be considered, especially for tall persons. For growing~     children, this can be easily accomplished with a small, minimally invasive, uncomplicated~     procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow~     derived mesenchymal stem cells can shorten the treatment period by acceleration of bone~     regeneration during distraction osteogenesis.~   "
179846|NCT01210937|"~     Carotid endarterectomy has been proven effective in prevention of cerebral vascular events in~     patients with severe carotid artery stenosis (symptomatic,>50%;asymptomatic,60%). But during~     the surgery, when the carotid artery is clipping, the patient will have the chance to have~     hypoperfusion or stroke. Our study is designed to determine how to use TCD to reduce the risk~     of death and nonfatal stroke in patients .~   "
179847|NCT01210924|"~     This is an observational cohort in pediatric HIV patients in China. Children who receive~     antiretroviral drugs will be recruited in this study. The main objectives are as follows: 1.~     To establish simpler and smarter pediatric antiretroviral therapy in China including both~     first-line and second-line regimens. 2. To study the nature, characteristics and mechanisms~     of immunoreconstitution in HIV-infected children using the data and samples from the~     pediatric antiretroviral therapy cohort. 3. To establish a basic science and clinical~     research network based on the pediatric antiretroviral cohort.~   "
179848|NCT01210911|"~     Pancreatic cancer patients have one of the worst prognoses among all cancer types with a 5~     year survival rate of less than 5%. Despite significant changes during the last decade in our~     molecular knowledge on this disease, the prognosis and management of pancreatic cancer have~     remained unchanged. With the advances in molecular biology, newer biologic agents such as~     erlotinib, are adding some benefit to the conventional cytotoxic agents. There is a growing~     body of literature suggesting that type 2 diabetes mellitus (DM) may be associated with the~     development of pancreatic cancer, but this association is complex. Because various DM~     medications can affect directly the key factors mediating the association between DM and~     pancreatic cancer, understanding the effect of anti-diabetic therapies on pancreatic cancer~     is a critical step in fully characterizing the role of type 2 DM in the development of~     pancreatic cancer. Indeed, two epidemiologic studies have found that diabetic patients~     treated with metformin were less likely to develop cancer, but those treated with insulin~     were more likely to die of various kinds cancer. Not only does metformin ameliorate~     hyperglycemia and hyperinsulinemia, both of which are associated with the adverse impact of~     DM on cancer, metformin also has direct metabolic effects through activation of adenosine~     monophosphate-activated protein kinase (AMPK). AMPK regulates many metabolic enzymes and also~     inhibits the mammalian target of rapamycin (mTOR) pathway via phosphorylation and~     stabilization of the tumor suppressor gene TSC2. But there is an intensive cross-talk between~     various pathways. Inhibition of the phosphoinositide 3-kinase (PI3K)/Akt pathway, of which~     mTOR is one of the effector proteins, for instance may result in escape via the~     mitogen-activated protein kinase (MAPK) pathway and vice verse. Indeed, epidermal growth~     factor receptor (EGFR) activation leads to activation of the MAPK pathway and the PI3K~     pathway. Thus, since it is clear that blocking one pathway will not always be sufficient to~     produce a response in the presence of other activated pathways, the best change of success~     will be realized when using a combination of agents that inhibit separate pathways known to~     be critical to the survival of the tumour. In line with these observations, combining a small~     molecule against the EGFR and inhibition of the PI3K pathway by metformin might account for~     potential candidates of the above combinatorial approach. Therefore, in this study, the~     investigators want to determine the activity and safety of concurrent interruption of the~     MAPK and PI3K pathways by the EGFR tyrosine kinase inhibitor erlotinib and metformin,~     combined with gemcitabine in patients with metastatic pancreatic cancer.~   "
179849|NCT01210898|"~     This study will evaluate the safety and immunogenicity of children previously primed in the~     V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.~   "
179850|NCT01210885|"~     The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity~     of two doses of 4 different investigational MenABCWY combination vaccine when administered to~     healthy adolescents aged 11-18 years.~   "
179851|NCT01210872|"~     RATIONALE: Gathering information over time about patients' quality-of-life and satisfaction~     with care may help doctors plan the best treatment and help patients live more comfortably.~      PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients~     with head and neck cancer treated with radiation therapy.~   "
179852|NCT01210859|"~     The purpose of this study is to check whether antimuscarinics that usually broadly used in~     the treatment of overactive bladder symptoms are effective in the treatment of those symptoms~     after insertion of ureteral stents. In order to study the efficacy of the treatment of OAB~     symptoms in stented patients the investigator will use a suitable questionnary.~   "
179853|NCT01210846|"~     The purpose of this study is to obtain QTc data, to assess the effects of tivozanib on ECG~     morphology, and to determine the pharmacokinetic pharmacodynamic (PK-PD) relationship between~     any observed changes in cardiac repolarization (defined by QTcF duration) and the serum~     concentration of tivozanib.~   "
179854|NCT01210833|"~     HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It is~     composed of a glove with optic sensors detecting the movements of the wrist and the fingers~     with a biofeedback software designed to evaluate and then to exercise the hand movements~     through supplying a variety of computer graphic patterns.~      The HandTutor has been used and tested with a stroke population, and it seems potential to be~     used with hand injuried population. As a first step, it is important to investigate the~     characteristics of the system and how it is matching the hand injuried population.~      The purpose if this study is to characterize the HandTuror system and the focused objectives~     are:~        1. To examine the test-retest reliability of the system when measuring the range of motion~          (ROM) of the the fingers among healthy people (control group).~        2. To examine the correlation between the ROM measured by the HandTutor and the ROM~          measured by conventional assessment tools (goniometer).~        3. To examine the ability of the system to distinguish between healthy people and hand~          injured people.~        4. To examine the correlation between the performance in the HandTutor (in the games part),~          and the performance in functional activities.~        5. To examine the participants feedback for using the HandTutor (degree of enjoyment).~   "
179855|NCT01210820|"~     The results of this trial will demonstrate that ISAK performed with the iFS™ femtosecond~     laser is a safe procedure.~   "
179856|NCT01210807|"~     The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens~     (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general~     postoperative outcomes of the One-Piece Tecnis Multifocal lens.~   "
179857|NCT01210794|"~     The influence of different food componente on zinc absorption in young adults consuming zinc~     fortified porridge's prepared from maize, beans and sorghum: a series of six similar~     randomized, single-blind studies.~   "
179858|NCT01210781|"~     Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's~     disease and other indications. A common target for stimulation is the subthalamic nucleus~     (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical~     improvement.~      The project aims to describe the variability of target coordinates in the patient group and~     to relate it to clinical outcome as documented in standardized questionaires.~        -  Trial with surgical intervention~   "
179859|NCT01210768|"~     Primary objective:~        -  To evaluate the disease-free survival (DFS) in the two randomized arms after therapy~          with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer~      Secondary objectives:~        -  To assess the overall survival (OS)~        -  To establish the safety profile by assessing the toxicities and tolerability~        -  To assess the quality of life (QoL)~        -  To evaluate survival correlation with biomarkers expression.~   "
181803|NCT01185184|"~     This study will explore the drug behavior and safety following single dose of two 20~     milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a~     10 milligram immediate release tablet, using a 3 way crossover design.~   "
179860|NCT01210755|"~     The purpose of this study is to evaluate whether the effect of the two new anticoagulants,~     Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For~     Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex~     concentrate (PCC), recombinant activated coagulation factor VII, and activated~     prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific~     Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from~     healthy male volunteers.~   "
179861|NCT01210742|"~     Treatment for early osteoarthritis (OA) of the knee is an increasing problem yet much of the~     research into OA, to date, concentrates on predisposition, genetic and cellular aspects and~     the treatment of late stage disease (arthroplasty). Clinicians reviewing patients with early~     OA have great difficulty in recommending an appropriate and efficacious intervention.~      The first line of treatment for patients with early OA is exercise, self-management and~     weight loss. These tools are suggested to minimize the need for higher risk treatments such~     as non-steroidal antiinflammatory drugs (NSAIDs) and surgery. Viscosupplementation using~     intra-articular injections of hyaluronan (Synvisc One) is a relatively new treatment. To~     date, the ideal patient for viscosupplementation has yet to be defined. It is not known~     whether incorporation of viscosupplementation into the overall clinical management will have~     beneficial influence for patients with early OA of the knee.~      This study will generate rigorous pilot data to assess the need and inform a larger~     randomized controlled trial (RCT) assessing the efficacy of viscosupplementation. The study~     will be a single blind randomised RCT. 60 patients with documented early OA will be~     randomised into one of two groups; Group V will undergo one shot viscosupplementation using~     Synvisc One in addition to routine physiotherapy management for knee OA. Group No V (control)~     will have no viscosupplementation but will undergo similar routine management including~     physiotherapy management for knee OA. Outcome measures will include walking pain (The Western~     Ontario and McMaster Universities Arthritis Index-WOMAC), the overall WOMAC score, Oxford~     Knee Score (OKS), American Knee Society score (AKS), complications, activity level and~     patient satisfaction. Health economics will also be evaluated. Measurements will be recorded~     pre-intervention and at six months following treatment.~      The risks associated with viscosupplementation are minimal. Considering the limited resources~     currently available in health care, if the latter is shown to have higher effectiveness than~     physiotherapy alone, in addition to patient benefit, there will be important health economic~     implications.~   "
179862|NCT01210729|"~     The objective of this study is to collect data on the use of the SOLITAIR FR device for~     treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether~     the application of SOLITAIR is a safe and feasible method for interventional recanalization~     of large vessels with favorable patient outcome in acute stroke therapy.~   "
179863|NCT01210716|"~     This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma~     Exchange (TPE) is prescribed by their physicians.~   "
179864|NCT01210703|"~     Acoustic Pharyngometry (AP) is a method of measurement of Transversal Sectional Areas (TSA)~     and Volumes of oral cavity and pharynx, based on acoustic waves. The aim of this study is to~     describe changes on oropharynx dimensions caused by CPAP (Continuous Positive Air Pressure)~     in patients with severe Obstructive Sleep Apnea Syndrome when compared with patients with~     Primary Snore, using AP. The exam will be made during the use of CPAP, at various pressures.~     The investigators also intend to determine if pressure determined by Polysomnography in OSAS~     patients cause some type of different change in AP graphic.~   "
179865|NCT01210690|"~     The purpose of this observational study is to broaden the knowledge of the known safety and~     efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than~     12 months when treated according to routine clinical practice. Their data will be collected~     until they reach the age of 13 months.~   "
179866|NCT01210677|"~     There are no published clinical consensus guidelines on the treatment of cardiac sarcoidosis.~     Corticosteroid therapy is advocated by some experts, but is based on small observational~     studies, with varied clinical response.~      Objectives of this trial:~        -  to systemically assess the response of patients with cardiac sarcoidosis, to treatment~          with corticosteroids~        -  to identify the clinical predictors of response to treatment with corticosteroids~        -  to assess the utility of imaging with PET and MRI to predict response to treatment with~          corticosteroids~        -  to determine the prevalence of cardiac sarcoidosis in young patients with unexplained~          heart block and in patients with unexplained dilated cardiomyopathy associated with~          ventricular tachycardia~        -  to use the data from this pilot study to assess the need, feasibility, and sample size~          for a larger multicentre trial~   "
179867|NCT01210664|"~     The investigational therapy under study in this trial, regulatory T cells (Tregs), offers the~     hope of stabilizing further destruction of insulin producing beta cells in type 1 diabetes.~     Tregs are a specialized subset of T cells that function to control the immune response.~     Pre-clinical studies in non-obese diabetic mice have demonstrated that adoptive transfer of~     Tregs can slow diabetes progression and, in some cases, reverse new onset diabetes. The~     primary purpose of this Phase 1 study is to assess the safety and feasibility of intravenous~     infusion of ex vivo selected and expanded autologous polyclonal Tregs in patients with type 1~     diabetes (T1DM) to support dose selection for a future efficacy trial. The study also aims to~     assess the effect of Tregs on beta cell function as well as on other measures of diabetes~     severity and the autoimmune response underlying T1DM.~   "
179868|NCT01210651|"~     This was a randomized controlled pilot trial to evaluate clinical efficacy and feasibility of~     hatha yoga as a mono-therapy for major depression. Investigators recruited 38 adults in San~     Francisco meeting criteria for major depression of mild-to-moderate severity, per structured~     psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At~     screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy,~     herbal/nutraceutical mood therapies, or mind-body practices were excluded. Twenty~     participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8~     weeks. Eighteen participants were randomized to 90-minute attention control education groups~     twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a~     university clinic. Primary outcome was depression severity, measured by BDI scores every 2~     weeks from intervention start at 0 weeks until finish at 8 weeks. Secondary outcomes were~     self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES)~     and Rosenberg Self-Esteem Scale (RSES) at 0 weeks and 8 weeks. Blinded assessors analyzed~     whether change in outcome measures would be statistically comparable between the two~     intervention groups.~   "
179869|NCT01210638|"~     The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10~     mg Tablets under fasting conditions~   "
179904|NCT01210183|"~     Dextrose injection in end-stage knee arthritis will cause growth of cartilage cells in a~     particular area of complete cartilage loss. Dextrose concentration will be 12.5%. Cartilage~     status will be monitored by pre and post treatment arthroscopy views with specialized~     (methylene blue) staining for cartilage.~   "
179870|NCT01210625|"~     The investigators hypothesize that daily oral intake of starch-entrapped alginate~     microspheres (called Nutrabiotix fiber) is well tolerated, exhibits no or minimal typical~     side effects of fiber (e.g. bloating, loose stool, flatulence), can be used as an ideal~     vehicle to deliver anti-oxidants/anti-inflammatory natural and synthetic substances/agents;~     and promote gut health by improving bowel habit, by changing the gut microbiota and~     increasing production of short chain fatty acids, especially butyrate, in the colon and~     decreasing production of protein putrification (prebiotic effects).~   "
179871|NCT01210612|"~     Lateral ankle sprain (LAS) is one of the most common injuries in sports. There is a unique~     style of socks that have become popular in Japan among athletes that could also improve~     postural control. The purpose of the study is to determine the effectiveness of five-toed~     socks on dynamic postural control in individuals with and without chronic ankle instability.~   "
179872|NCT01210599|"~     INTRODUCTION Pamidronate and other bisphosphonates (bisph) have an anti-nociceptive effect in~     animals. In humans, IV pamidronate is analgesic in patients affected by numerous painful~     conditions, including cancer bone pain, complex regional pain syndrome (CRPS), ankylosing~     spondylitis, and rheumatoid arthritis. The investigators have explored the effect of IV~     pamidronate in the management of chronic low back pain (CLBP), a worldwide public health~     problem in terms of lost workdays, treatment costs, and suffering.~      The study was a randomized, double blind, dose-escalation trial of IV pamidronate. Study~     participants were divided among four study phases. Each group received IV placebo or~     escalating doses of IV pamidronate.~      STUDY DESIGN A phase I-II, randomized, double-blind, placebo controlled, dose finding study~     for the treatment of patients with CLBP with IV pamidronate. The study was first conducted at~     Beth Israel Medical Center, NY for the first two groups, and was completed at Mount Sinai~     Medical Center , NY for the remaining groups.~      PRIMARY OBJECTIVES The intent of this pilot study was to determine the optimal IV pamidronate~     treatment protocol for CLBP in a Phase III trial. Primary study aims were safety and average~     daily pain. Subjects used an electronic diary (LOGPAD) to record their daily adverse events~     (AEs) and their baseline and post-treatment average pain on the 0-10 numerical rating scale~     (NRS).~      STATISTICAL ANALYSES All the analysis were performed on an intention-to-treat basis. Primary~     outcomes are LOGPAD change in pain severity and whether a patient was a responder (pain score~     dropped ≥2 points or ≥30%). Because there was no statistical difference in these two outcomes~     among the 4 placebo groups, all placebo patients were combined (Comb PL) in the subsequent~     analyses. Primary analytic tool was mixed model for repeated measures (MMRM), assuming~     autoregressive covariance structure (LOGPAD pain and Brief Pain Inventory - BPI~     interferences), and Generalized Estimating Equation (GEE) model for categorical outcomes~     (Response rates and Patient Global Impression of Change - PGIC). The main objective was to~     assess whether the changes in outcome from baseline or the response rates were the same~     across the study phases, while adjusting for baseline values and time effect. Least square~     means were contrasted. Interaction between time and study phases were also tested to see if~     the treatment effect is a function of time. Fisher's exact tests or ANOVA (Kruskal-Wallis)~     tests were performed for cross-sectional group comparison, including baseline.~   "
179873|NCT01210586|"~     This study investigated whether being on transdermal hormone replacement therapy (HRT)~     influenced smoking cessation variables in postmenopausal women undergoing short-term~     abstinence from cigarettes. Women were recruited into two groups according to their~     pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT~     group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system~     and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants~     continued smoking as usual for one week, at which time baseline measurements were taken. For~     the remaining two weeks, participants were instructed to quit smoking. They were provided~     with smoking cessation counseling and monitored for abstinence. Data were collected during~     five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck~     Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction~     Time Test.~      Part II is identical to Part I, except it randomizes participants to use nicotine patch or~     not.~   "
179874|NCT01210573|"~     To observe and document ventilation parameters in the advanced heart failure population,~     through the course of illness, which often includes cardiac resynchronization therapy (CRT),~     left ventricular assist device (LVAD), and transplant. Findings from this cohort are~     anticipated to be of sufficient interest to the scientific community to merit publication and~     are likely to provide preliminary data for future hypothesis generation and subsequent~     prospective, randomized controlled trials.~      A compact, inexpensive apparatus has recently become commercially available for performing~     sub-maximal exercise testing (SHAPE Medical, St Paul, MN), including gas exchange analysis~     and will be used in this study. This apparatus is not investigational.~   "
179875|NCT01210560|"~     To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of~     tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals~     of this trial are two-fold:~        1. To directly compare the immediate release (IR) and MR formulations~        2. To determine the dose range and dose regimen for MR (dose finding)~   "
179876|NCT01210547|"~     The goal of this project is to reduce the radiation exposure in orthodontic patients by the~     use of a new imaging protocols based on non-ionizing orthodontic records (e.g. digital dental~     models, three-dimensional photograph) The first step in this process is to develop and~     validate an orthodontic analysis able to assess craniofacial proportions, dental, skeletal,~     and facial soft tissue. The investigators working hypothesis is that data from~     three-dimensional facial photographs and from digital dental casts can be registered~     accurately and consistently, and the diagnostic information about tooth position and facial~     soft-tissue derived from them are comparable to x-ray derived data~   "
179877|NCT01210534|"~     Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.~   "
179878|NCT01210521|"~     The purpose of this study is to determine the effects of vitamin D3 on severe asthmatic~     patients. Vitamin D3 may alter the response of these patients to conventional steroid~     therapy, making them more responsive to the latter form of treatment. Patients will be~     treated daily with an oral dose (2,000 IU) of vitamin D3 for one month and their clinical and~     serological parameters, and immune function, will be evaluated. Results from pre- and~     post-vitaminD3 treatment will be compared.~   "
179916|NCT01210027|"~     Researchers at the the University of Michigan are conducting a research project to assess how~     a course of radiation therapy changes the way blood flows through the liver. To be able to do~     this, the researchers will be using MRI (magnetic resonance imaging) scans completed before,~     during, and after radiation therapy. MRI's will be done on 4 or 5 occasions. On each~     occasion, you will be injected with a fluid called gadolinium (a contrast agent) before~     getting an MRI. This contrast agent makes it easier for the Researchers to see your organs in~     the scans, and causes any abnormal areas to become very bright on the MRI. This agent will be~     injected into a vein in your arm or leg. Each MRI scan will last approximately 45 minutes.~   "
179879|NCT01210508|"~     70% of all cancer patients develop some form of visceral (internal organs) or skeletal~     metastases (spread of disease). Approximately one third of cancer patients develop metastases~     to the spinal column. The prognosis once spinal metastases have been diagnosed and the most~     appropriate treatment still remains controversial. To date there is no one good diagnostic~     tool to predict survival and/or outcome after radiotherapy or surgical intervention.~      Tokuhashi, et al, formulated and presented a preoperative scoring system to evaluate~     indications for surgery and predict outcome in patients with metastases to the spinal column.~     Six variables are measured to calculate this score: general medical condition, number of~     extraspinal metastases, number of vertebral metastases, status of metastases to the major~     internal organs, primary tumor type, and presence of a neurologic deficit. This scoring~     system has been gaining acceptance in literature. In 1998, Tokuhashi, et al, modified this~     scoring system by diversifying the tumor types into six categories. After a retrospective~     analysis Tokuhashi reported that patients with scores less than or equal to 8 will die of~     their disease within 6 months and those with scores of 12 or greater will survive an average~     of 12 months or more.~      The purpose of this study is to determine 1) the Tokuhashi score's validity in predicting~     survival after developing spinal metastases, 2) the relationship of treatment on survival~     after detecting spinal metastases in relation to the Tokuhashi score. Patients will be~     enrolled into the study and followed prospectively for as long as possible regardless of~     intervention.~      There will be three groups based on their Tokuhashi score, each group will require~     approximately 163 subjects statistically.~   "
179880|NCT01210495|"~     The study is designed to demonstrate that axitinib plus best supportive care is superior to~     placebo plus best supportive care in prolonging survival in patients with advanced~     hepatocellular carcinoma.~   "
179881|NCT01210482|"~     The objective of this investigation is to determine the following items in all patients~     receiving Torisel for a certain period after marketing:~        1. Confirmation of efficacy and safety for medical practice use.~        2. Investigation of factors that may influence the incidence of adverse events~          (Particularly priority investigation items).~        3. Investigation of the incidence status and the risk factors for interstitial lung~          diseases.~   "
179882|NCT01210469|"~     The purpose of this study was compare the efficacy of two exercise programs - the first~     consisting of balance training and muscle strength and the second consisting of balance~     training and muscle stretching exercises - to improve postural control in elderly women with~     osteoporosis.~   "
179883|NCT01210456|"~     Contrast-Induced Acute Kidney Injury(CIAKI) was defined as an absolute increase in serum~     creatinine of more than or equal to 0.3mg/dl (≥ 26.4 μmol/l), a percentage increase in serum~     creatinine of more than or equal to 50% (1.5-fold from baseline) within 48 hours of~     intravascular contrast administration in the absence of any alternative causes, or a~     reduction in urine output documented oliguria of less than 0.5 ml/kg per hour for more than~     six hours.~      It is the common cause of new hospital-acquired renal insufficiency. The occurrence of CIAKI~     may be influenced by pre-existing renal insufficiency, diabetic nephropathy, dehydration,~     congestive heart failure, concurrent administration of nephrotoxic drugs, or the dose and~     type of contrast media used. Previous studies have shown the independent effectiveness of~     several agents in preventing CIAKI.~      Even now, hydration is crucial for preventing CIAKI. Since CIAKI is presumed to be caused by~     free radical generation, N-Acetylcysteine, which is a potent free radical scavenger, is shown~     to be effective in preventing nephropathy. At the same time, because free radical formation~     is promoted by an acidic environment, bicarbonate, which alkalinizes renal tubular fluid, has~     been shown to reduce renal involvement.~      These days, some studies have shown that hydration with sodium bicarbonate plus~     N-Acetylcysteine was effective and safe in the prevention of CIAKI. In these studies,~     bicarbonate was used for both alkalinizing renal tubular fluid and hydration. However, if we~     want to do hydration, we can use saline and if we want to alkalinize renal tubular fluid, we~     might use bicarbonate by bolus injection.~      Actually, bicarbonate for hydration is prepared at sterile preparation room in a hospital,~     which is very cumbersome procedure and increase in cost. This is one of the reasons that~     bicarbonate for hydration use does not become common with wide clinical application.~      In past issues, though it differs depending on the level of the renal dysfunction, the~     probability of CIAKI was 8-33% when hydration was administered, 5-15% when hydration and~     N-Acetylcysteine were administered, and 1.8-1.9% when bicarbonate and N-Acetylcysteine were~     administered.~      Thus, we can hypothesize the combination of N-Acetylcysteine and bicarbonate will play a~     complementary role in preventing contrast-induced nephropathy.~      This is the rational for this study.~   "
179884|NCT01210443|"~     The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were~     demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU,~     Canada and Australia. In this study, the long-term safety and efficacy after administrations~     of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will~     be investigated in Japanese PAH patients.~   "
179885|NCT01210430|"~     The investigators study will determine how often blood flow regulation abnormalities and~     abnormalities of sympathetic regulation produced by nitric oxide, angiotensin-II, and~     oxidative stress occur in POTS and the mechanism(s) of POTS in individual patients. Specific~     causes for POTS may vary from patient to patient. Patients will be compared to healthy~     control subjects. There is a treatment arm with a medication (losartan) that reduces the~     binding of angiotensin and increases NO. If the investigators know the specific biochemical~     mechanism the investigators may be able to offer further specific treatments to specific~     patients.~   "
179886|NCT01210417|"~     In the prehospital setting it would be helpful to assess primary changes in central blood~     volume or preload (venous return, stroke volume, diastolic ventricular volume) that occur~     during the stability phase following injury when regulatory mechanisms are still functioning.~      Obviously in this setting a non invasive bedside beat-to-beat index would be helpful.~      Pulse Transit Time (PTT) is the sum of Pre-Ejection Period (PEP), the time interval between~     the onset of ventricular depolarization and the ventricular ejection, and Vascular Transit~     Time (VTT), the time it takes for the pulse wave to travel from the aortic valve to the~     peripheral arteries (Obrist et al. 1979). PEP variations are known to correlate with~     reductions in central blood volume induced by head-up tilt (Chan et al., 2007b, 2008). The~     same authors also demonstrated that PTT variations follow closely PEP variations and~     therefore central blood volume variations (Chan et al., 2007b). Following central blood~     volume reductions induced by head-up tilting ventricular diastolic filling time increases~     involving an increase in PEP and PTT. Chan et al. (Chan et al., 2007b) concluded that PTT~     could have been used to assess early central hypovolemia and suggested that joint analysis of~     PTT and RR intervals could help in predicting the extent of blood volume loss. The~     investigators hypothesized that sympathetic drive associated with trauma would act on cardiac~     contractility through beta activity thus shortening PTT without reducing RR interval to the~     same extent in healthy hearts. We also hypothesized that progressive hypovolemia would lead~     to a rising of PTT (augmented diastolic filling time) and a RR interval shortening (relative~     tachycardia). In this study the investigators propose and index based on the beat-to-beat~     PTT/RR ratio to assess central hypovolemia in traumatic patients enrolled by our Helicopter~     Emergency Medical System (HEMS) in a prehospital setting.~   "
179887|NCT01210404|"~     Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C~     infection. Given the likelihood of co administration of filibuvir and methadone, this study~     will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.~   "
179888|NCT01210391|"~     The primary objective of the clinical trial is to compare growth in infants (expressed as~     weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants~     consuming a commercially available EHF.~   "
179889|NCT01210378|"~     Nitroglycerin is a nitric oxide donor which is mainly known as a vasodilating agent used in~     ischemic heart disease. It has also been shown to increase tumor blood flow in animal and~     human tumors.~      The addition of nitroglycerin to chemotherapy in non small cell lung cancer has been shown to~     generate very favorable response rates with respect to standard treatment schedules[5].~     Theoretically nitroglycerin might reduce resistance to chemotherapy via a plethora of~     different effects: better tumor perfusion, direct effects of NO on cancer cells, increase in~     activated p53 protein and via an increased blood flow in the tumour with as consequence a~     higher drug concentration in the tumor [6] .~      In mice, nitric oxide donors such as isosorbide dinitrate have been shown to decrease tumor~     hypoxia by better tumor perfusion, which could enhance radiotherapy responses [7].~      To date these combined effects have not been tested in humans. In this trial we would like to~     demonstrate the effect of nitroglycerin on tumor perfusion and hypoxia in non small cell lung~     cancer (using DCE and HX4 scanning), providing a rationale for further study and to test the~     effect of combining nitroglycerine to standard treatment of NSCLC~     (radiotherapy/chemotherapy).~   "
179890|NCT01210365|"~     The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg~     + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)~   "
179891|NCT01210352|"~     The purpose of this study is to evaluate the effectiveness, tolerability, and safety of~     oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain~     in pediatric subjects.~   "
179892|NCT01210339|"~     The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic~     Acid (ASA) 81 mg affect the metabolism of clopidogrel.~   "
179893|NCT01210326|"~     Azoospermia , as the name suggests , refers to the condition in which there are no sperm in~     the semen. This diagnosis can come as a rude shock, because most men with a zero sperm count~     have normal libido; normal sexual function; and their semen looks completely normal too. The~     diagnosis can only be made by examining the semen under a microscope in the laboratory.Men~     with non-obstructive azoospermia have a normal passageway, but abnormal testicular function,~     and their testes do not produce sperm normally. Some of these men may have small testes on~     clinical examination. The testicular failure may be partial, which means that only a few~     areas of the testes produce sperm, but this sperm production is not enough for it to be~     ejaculated. Other men may have complete testicular failure, which means there is no sperm~     production at all in the entire testes. The only way to differentiate between complete and~     partial testicular failure is by doing multiple testicular micro-biopsies to sample different~     areas of the testes and send them for pathological examination. This technique is called~     TESA, or testicular sperm aspiration ( also known as TESE, or testicular sperm extraction) or~     mTESE ( micro-testicular sperm extraction).~   "
179894|NCT01210313|"~     -  feasibility of physical activity~        -  increase of physical conversation~        -  Quality of Life (optional)~        -  vascular and metabolic effects~   "
179895|NCT01210300|"~     The incidence of caesarean section (CS) has increased globally. Taiwan's statistics report a~     higher incidence of repeat CS compared to vaginal birth after caesarean (VBAC). This is~     concerning, as repeat CS are associated with increased maternal morbidity and mortality, and~     neonatal respiratory problems. VBAC is an approach which reduces the likelihood of such birth~     complications. However, there is limited information about Taiwanese women's decision~     regarding VBAC and their participation in decision-making. There is also a gap in literature~     about information for women about CS and VBAC.~   "
179896|NCT01210287|"~     The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in~     Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis~     B undergoing RCHOP immuno-chemotherapy.~   "
179897|NCT01210274|"~     Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71~     years). IPSS classification defines low risk (Low and Intermediate 1), and high risk~     (Intermediate 2 and High) MDS. High-risk MDS (MDS-HR) have a high risk of transformation into~     acute leukemia with multilineage dysplasia (AML-DML). The success of Azacitidine has been~     mainly achieved through a rigorous empirical and clinical research, but the molecular~     mechanisms by which this molecule exerts its effects remain poorly characterized. The primary~     mode of action of Azacytidine is through DNA demethylation, and integration in to mRNA that~     favor traduction inhibition. The impact of this molecule on various cell death programs~     involved in the elimination of leukemic cells : apoptosis and autophagy is currently poorly~     known.~      The research program and clinical studies we proposed focus on two major aspects:~      - Main objective: Molecular mechanism of action and resistance to Azacitidine: Role of~     apoptosis versus autophagy.~      - Secondary Objective: Reversion of Azacytidine resistance using different drugs targeting~     apoptosis and/or autophagy. Our laboratory has identified new molecules to selectively induce~     different types of cell death (apoptosis or autophagy).~   "
179898|NCT01210261|"~     Obstructive sleep apnea (OSA) is a condition of disordered breathing characterised by~     intermittent partial and/or complete upper airway obstruction during sleep. The participants,~     naive to nasal continuous positive airway pressure (CPAP), recently diagnosed with OSA, will~     undergo two automatic CPAP titration studies with collection of polysomnographic (PSG) data.~     The data will be analysed to assess effectiveness of Compumedics auto-CPAP device in the~     normalisation of sleep disordered breathing in OSA patients, with respect to another~     auto-CPAP device.~   "
179899|NCT01210248|"~     The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel~     metabolite in plasma and platelet inhibition status.~   "
179900|NCT01210235|"~     The investigators overall goal is to develop, implement, test, and disseminate an~     intervention to increase colorectal cancer screening rates at Kaiser Permanente (KP) by~     providing home fecal immunochemical test kits (FIT) to eligible patients aged 50 and older~     who participate in annual influenza vaccination campaigns. The investigators hypothesis is~     that the FLU-FIT Program will be an effective method to increase colorectal cancer screening~     rates at Kaiser Permanente.~   "
179901|NCT01210222|"~     This phase II trial studies the side effects and how well trebananib works in treating~     patients with persistent or recurrent endometrial cancer. Trebananib may stop the growth of~     endometrial cancer by blocking blood flow to the tumor.~   "
179953|NCT01209546|"~     The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.~   "
179905|NCT01210170|"~     Glucocorticosteroids inhibit the disposal of organic cations by blocking organic cation~     transporters expressed by non-neuronal cells, thereby interfering with the inactivation of~     the organic cations by intracellular enzymes. Beta2-adrenergic agonists are organic cations,~     and the concentration of inhaled beta2-adrenergic agonists at beta2-adrenergic receptor sites~     on smooth muscle is likely to be increased by inhaled glucocorticosteroids (ICS) by the ICS'~     effect on the glucocorticosteroid-sensitive organic cation transporters. The investigators~     have shown in human airway vascular smooth muscle cells that the glucocorticosteroid action~     on organic cation uptake occurs within minutes, does not involve gene transcription or~     protein synthesis, is not mediated through classical steroid receptors, and is cell~     membrane-linked.~      In the present proposal, the investigators wish to use different single doses of mometasone,~     a clinically effective ICS, administered with or at different times before albuterol~     inhalation in subjects with moderate persistent asthma who are obstructed at the time of~     study.~      With this approach the investigators will test the hypothesis that a single inhalation of~     mometasone causes an acute, transient, dose-dependent potentiation of beta2-adrenergic~     bronchodilation.~      If the hypothesis that a single dose of mometasone acutely potentiates beta2-adrenergic~     bronchodilation is correct, the results would have a significant impact on treatment~     strategies involving ICSs and beta2-adrenergic agonists in patients with asthma.~   "
179906|NCT01210157|"~     The purpose of this study is to determine whether galectin-3 binding protein plasma levels~     can predict adverse cardiovascular events in patients with coronary artery disease and/or~     heart failure.~   "
179907|NCT01210144|"~     This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the~     gene expression profiles and histologic changes of the endometrial tissue before and after~     stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic~     markers in assisted reproductive technologies (ART) in addition to the clinical predictive~     factors already known. Among those predictive factors, the state of the endometrium is~     considered as an important implantation determining factor for which pharmacogenomic research~     is of great interest.~      The direct benefits of this study will be to know whether the endometrial gene expression~     profile is modified in response to stimulation treatment and have an impact or not on the~     endometrial tissue receptivity. The potential benefits of this study could be to assess the~     therapy optimization based on individual treatment response and gene expression profile~     compared to group treatment response in infertile women and prediction of response to therapy~     based on gene expression profiling before and after Gonal-f® stimulation in infertile women.~   "
179908|NCT01210131|"~     Since radiation dose escalation to a large volume of tumour inevitably will induce higher~     toxicity than is currently the case, efforts must be made to limit the volume of tissue~     irradiated. Moreover, the irradiation of larger tumour volumes leads to a lower achievable~     tumour dose when keeping the normal tissue doses constant. Central is thus the question~     whether it would be possible to limit the volume of tumour to be boosted by selectively~     escalating the radiation dose to specific disease sites which are theoretically more prone to~     relapse.~   "
179909|NCT01210118|"~     The aim of this clinical trial is to test whether offering pregnant smokers a high intensity~     intervention for smoking cessation increases the rate of smoking cessation at the third~     trimester of pregnancy, compared to low intensity intervention for smoking cessation that is~     the usual care, control condition.~   "
179910|NCT01210105|"~     To determine whether video laryngioscopes facilitate intubation in ice-pick position in a~     manikin with restricted access to the airway~   "
179911|NCT01210092|"~     To determine whether different video laryngoscopes facilitate intubation in an manikin with~     immobilized cervical spine compared with standard laryngoscopy.~   "
179912|NCT01210079|"~     Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the~     ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced~     hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients.~     Specifically, in a sample of MM patients, gabapentin, which has proven efficacy in treating~     neuropathic pain will be evaluated for its ability to ameliorate or diminish the~     opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and~     tolerance to both cold-pressor and electrical pain, at peak and through methadone blood~     levels. The results of this work will not only provide pharmacologic insight into the~     mechanisms underlying poor pain tolerance in this at-risk population, but also direction for~     the medical management of pain complicated by opioid-induced hyperalgesia.~   "
179913|NCT01210066|"~     Providing pain management to the patient who abuses prescription opioids presents a clinical~     challenge, not only due to concerns about drug-seeking, but because they have increased~     sensitivity to pain, a phenomenon identified as opioid-induced hyperalgesia (OIH). In an~     effort to improve pain treatment, the aims of the proposed work are to evaluate the analgesic~     and hyperalgesic effects of opioids to acute pain in this vulnerable population, and to~     examine the role of opioid-induced proinflammatory changes in these responses.~   "
179914|NCT01210053|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether~     sunitinib is effective in treating non-small cell lung cancer.~      PURPOSE: This phase II trial is studying sunitinib to see how well it works when given as~     maintenance therapy in treating patients with stage III or stage IV non-small cell lung~     cancer which is previously treated with combination chemotherapy.~   "
179915|NCT01210040|"~     A randomized double-blind controlled trial will be carried out in which young, nulliparous~     (having never given birth) women will be randomly assigned to receive weekly supplementation~     with either iron and folic acid or folic acid alone. Women will be followed-up weekly up to~     18 months. Women who become pregnant will be followed-up until delivery. Malaria risk in both~     groups will be compared by assessing the prevalence of peripheral parasitaemia at the first~     antenatal clinic visit for pregnant women and at the end of the first malaria transmission~     season for non-pregnant women. The incidence of clinical malaria will be assessed by active~     and passive case detection throughout the follow-up period.~   "
179954|NCT01209533|"~     The purpose of the study is to determine if inhaled iloprost given four times daily can~     improve symptoms and lung function in adults with mild asthma.~   "
179917|NCT01210014|"~     Recurrent aphthous stomatitis (RAS) is one of the most common of oral mucosa diseases that~     affects approximately 20% of the general population. Despite the fact that clinical,~     pathologic and therapeutic feature of the disease has been comprehensively studied, the~     pathophysiology of aphthous ulcers remains incompletely understood.~      Zinc is a potent catalyst of wound healing and zinc deficiency may be a common cause of~     delayed tissue repair. Use of zinc sulfate in promotion wound healing and preservation of~     epithelial integrity advocated its possible use in the treatment or prevention of recurrent~     oral ulcers.~      The purpose of the present study was to determine of systemic zinc sulphate in the treatment~     of recurrent aphthous stomatitis.~   "
179918|NCT01210001|"~     This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients~     in order to provide these data for approval for BI 10773 by regulatory authorities as an~     antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.~   "
179919|NCT01209988|"~     To date, there is a lack of consensus concerning the optimal timing for removal of the~     urethral catheter, its related complications, the effectiveness in prophylactic drug use to~     reduce complication, and the patient reported outcomes (quality of life) after robot-assisted~     laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of~     tamsulosin on voiding patterns following early urethral catheter removal after RALP for~     prostate cancer.~   "
179920|NCT01209975|"~     The purpose of this study is to assess retinal blood flow and vascular reactivity in patients~     with newly diagnosed primary open angle glaucoma pre- and post-primary Selective Laser~     Trabeculoplasty(SLT). Canon Laser Blood Flowmeter will be used for the assessment of retinal~     blood flow.~   "
179921|NCT01209962|"~     Patients with pancreatic cancer are treated with combinations of surgery, radiation therapy~     and chemotherapy, depending on the location of the cancer and other individual patient health~     factors. The goals of therapy are to reduce or eliminate the cancer cells, but without~     serious damage to normal cells. Investigators at The University of Michigan are conducting a~     research project, to see if treatment effects on an individual patient's cancer cells can be~     detected early by new imaging tests in patients with resectable pancreatic cancer undergoing~     neoadjuvant chemoradiotherapy.~   "
179922|NCT01209949|"~     The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat~     mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and~     video diaries.~   "
179923|NCT01209936|"~     This was a pilot study to validate the BC3 hydration factor which will be important for~     determining how well this value represents hydration status compared to assessment of total~     body water by D20.~   "
179924|NCT01209923|"~     The purpose of this study was to validate the Stayhealthy BC1 bioelectrical impedance~     analyzer to assess percent body fat in children and adults. The BC1 was compared to~     dual-energy x-ray absorptiometry assessment of body fat for adults and to hydrostatic~     weighing assessment of body fat for children. We hypothesized that the BC1 would provide~     similar measures of body fat between devices with acceptable limits of agreement.~   "
179925|NCT01209910|"~     Inpatients in the neurology rehabilitation units at Riverview Health Center― people who are~     brain-injured and or who have had a stroke ― often have dysphagia as a result of their~     condition. They are considered at high risk of aspiration, which can result in pneumonia. To~     limit that risk, these patients are only allowed to consume thickened liquids at the~     beginning of their rehabilitation. They are restricted from consuming thin liquids, which~     means they can't even drink water. Depending on the rate of their rehabilitation, these~     restrictions can last from six months to a year.~      Patients on a diet of thickened liquids sometimes have difficulty consuming the required~     daily intake of fluids and they become dehydrated, which in turn can lead to other health~     complications. As well, thickened liquids do not always satisfy a patient's thirst, says~     Pooyania.~      While Riverview does not allow inpatients with dyspagia to have water at the beginning of~     their rehabilitation, many rehab facilities in Canada and the U.S. follow the Frazier Free~     Water Protocol, which does allow patients unrestricted water intake prior to and 30 minutes~     after meals. The belief that this protocol is safe is based on research done at the Frazier~     Rehabilitation Institute, where a study demonstrated no difference in rates of aspiration~     pneumonia between an experimental group on a free water protocol and a control group.~      The Frazer study was only one randomized controlled trial with a very limited number of~     patients. There have been a few case reports as well, but at Riverview centre, the protocol~     is not accepted because the investigators don't believe there is enough evidence behind it.~     The investigators intend to provide more clinical evidence so that both the risks and~     benefits of a free water protocol can be assessed.~      The investigators will be screening patients admitted to the neurology rehabilitation units~     at RCH, including both the stroke and acquired brain injury programs. The investigators~     expect to find at least 30 suitable candidates.~      Participants will be educated about dysphagia and the free water protocol, and the treatment~     group will be allowed unrestricted water intake prior to and 30 minutes after meals.~     Individualized intervention to minimize aspiration will be provided. Daily and weekly~     monitoring and testing of all patients will take place. The pilot study will continue for 11~     months. A secondary objective of the research is to determine the feasibility of expanding~     into a multi-centre clinical trial~   "
179926|NCT01209897|"~     The topic of this research is cigarette smoking cessation. We designed four smoking cessation~     booklets. These booklets are designed for smokers who differ in their motivation to quit~     smoking. We will compare different ways of matching booklets to smokers who vary in their~     motivation to quit smoking.~   "
179927|NCT01209884|"~     This research is being done to learn more about healthy aging. We hope to learn which bodily~     processes or functions are important for the elderly to maintain good health. Metabolites~     (for example, glucose) are small molecules in our bodies that are used in all bodily~     reactions. Looking at their levels in healthy elderly people may help researchers find out~     which processes lead some people to get to disease and others to not.~      Metabolites are the basic building blocks for people. They are used to construct larger~     complexes(such as proteins), relay signals from one part of the body to another, and as a~     source of energy.~      While most people have essentially the same types of metabolites, the relative levels of~     these metabolites vary from one individual to another. These levels reflect the body's state~     of growth, development, and reproduction. An appropriate balance in metabolites is important~     to maintaining general health. Conditions like cancer and diabetes result in disrupted levels~     of metabolites that are associated with changes in bodily functions. Deviations from normal~     levels of metabolites can be used as a signature for disease. Researchers have discovered~     that a disruption in unique metabolite levels is associated with human aging. In this study~     we hope to learn which, if any, of these disruptions are associated with the onset of~     age-related disease.~   "
179928|NCT01209871|"~     The goal of this clinical research study is to find the highest tolerable dose of a cancer~     vaccine that can be given to patients with asymptomatic lymphoplasmacytic lymphoma (LPL). The~     safety of this vaccine is also being studied.~      This is an investigational study. The vaccine is not FDA approved or commercially available.~     It is currently being used for research purposes only.~      Up to 12 patients will take part in this study. All patients will be enrolled at MD Anderson.~   "
179929|NCT01209858|"~     The purpose of this study is to investigate the effects of perampanel on the pharmacokinetics~     (PK) of a single-dose oral contraceptive (OC)containing ethinylestradiol (EE) and~     levonorgestrel (LN) (Microgynon-30) and to investigate the effects of repeated dosing of OC~     containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.~   "
179930|NCT01209845|"~     The investigators hope to see if a commonly used drug such as ketamine could help depressed~     ER patients feel better and improve their mood quickly.~   "
179931|NCT01209832|"~     The purpose of this study is to evaluate whether tasisulam acts as an inducer of CYP3A using~     midazolam as a sensitive and specific probe substrate of CYP3A.~      The study will also assess the safety and tolerability of tasisulam and midazolam given in~     combination and document any antitumor activity with tasisulam.~   "
179932|NCT01209819|"~     Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the enzyme~     phenylalanine hydroxylase (PAH). Elevated plasma levels of phenylalanine (phe) cause mental~     retardation, microcephaly, delayed speech, seizures, eczema, and behavior problems. Adequate~     control of the plasma levels of phe by a phe-restricted diet can prevent the developmental~     and behavioral problems.~      The foundation of this diet is a phe-free medical product/formula made from free amino acids.~     Based on longitudinal studies, it has been reported that the most benefit is attained by~     individuals who maintain a phe-restricted diet throughout life. Despite the obvious benefits~     of the diet, it has been suggested that the dietary restrictions may be associated with poor~     bone health in these patients. However, data supporting this has been reported in studies~     with small sample sizes and/or inadequate sample populations that include children. There is~     a paucity of data on bone health in adults with HPA.~      The investigators propose an observational study to describe the bone health status among~     adults with a diagnosis of HPA and to compare them to established normative age and~     gender-specific values among healthy individuals. The investigators hypothesize that adults~     with HPA will have lower bone density as measured by a dual x-ray absorptiometry (DXA) scan~     compared to the established normative values.~   "
179933|NCT01209806|"~     The purpose of this study is to determine whether the administration of PEG along with~     simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.~   "
179934|NCT01209793|"~     This study is being conducted to assess the safety and tolerability of a single ascending~     intravenous (IV) dose of REGN846 in healthy volunteers.~   "
179935|NCT01209780|"~     This study will evaluate the safety and immunogenicity in healthy children and adolescents~     after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.~   "
179936|NCT01209767|"~     This study intended to investigate and compare the changes that may occur in response to~     cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The~     cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational~     in the treatment of cellulite. It has previously been used for fat reduction on love handles~     or back fat. During cryolipolysis, the system drew fat tissue into an applicator then exposes~     the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die,~     with the goal to decrease the raised areas of cellulite. Subcision is a process used to treat~     scars left behind by acne or other skin diseases and has been noted to improve moderate to~     severe cellulite. Subcision is a simple surgical procedure that is performed by inserting a~     specially designed needle under the skin after local numbing medication is injected. The~     needle is moved in a repetitive motion parallel to the skin to separate the surface tissue~     from the deeper scar tissue with the goal to improve the dimpling caused by these tissues~     sticking together. This study was a pilot study designed to determine feasibility of these~     procedures.~   "
179937|NCT01209754|"~     The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of~     Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective~     observational cohort investigation of exposures to study agents under investigation for HIV~     prevention. The study population will consist of female participants who are identified as~     becoming pregnant during their participation in a microbicide or PrEP trial, or who have had~     planned exposures in pregnancy safety studies as well as their babies resulting from these~     pregnancies. This study will only enroll babies who have not yet reached their 1 year birth~     date.~   "
179938|NCT01209741|"~     This study will evaluate the comparative bioavailability of three capsule formulations of~     MK-0974.~   "
179939|NCT01209728|"~     This is a double-blind, parallel design study in elderly primary insomnia patients and~     demographically matched controls. The objectives if this study are primarily: 1. To determine~     if functional deficits in simulated driving performance can be demonstrated in primary~     insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily:~     2. To compare simulated driving performance deficits in elderly primary insomnia patients to~     those in healthy elderly volunteers impaired by alcohol, for at least one of the following~     driving endpoints: standard deviation of lane position (SDLP), standard deviation of speed~     (speed deviation), lane excursions, and a driving composite score.~   "
179940|NCT01209715|"~     In the present study, the investigators wish to address the effect of a~     glucocorticoid/long-acting beta-agonist preparation on endothelial function in COPD patients~     who do not currently smoke (ex-smokers) by measuring endothelium-dependent (albuterol~     response) and endothelium-independent (NTG response) vasodilation in the bronchial artery,~     reflecting endothelium-dependent and endothelium-independent vasodilation (drug-induced~     increase in Qaw, ΔQaw). With this approach the investigators will test the hypothesis that in~     stable ICS-naïve COPD patients, endothelium-dependent vasodilation is restored with a~     glucocorticoid/long-acting beta-agonist preparation, presumably resulting from the~     glucocorticoid component.~   "
179941|NCT01209702|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy~     of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have~     failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos~     factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to~     receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12~     weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4~     mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be~     followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week~     208 for all patients. Anticipated time on study treatment is 208 weeks.~   "
179942|NCT01209689|"~     This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of~     tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an~     inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were~     randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv)~     or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by~     open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all~     patients.~      This study and all further clinical development of tocilizumab AS was halted after a review~     of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in~     TNF antagonist naïve AS patients, failed to demonstrate efficacy.~   "
179943|NCT01209676|"~     A phase 0, exploratory study of the pharmacodynamics of a single intratumoral dose of~     IMCgp100, a monoclonal T cell receptor anti-CD3 scFv fusion protein, in subjects with~     advanced unresectable melanoma to assess the safety and pharmacodynamic properties of single~     intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Six patients~     will be enrolled to complete the study over approximately 12-15 months.~   "
179944|NCT01209663|"~     The objective of this trial is to evaluate postoperative intermediate care versus ward care~     in patients who have undergone emergency abdominal surgery with a perioperative Acute~     Physiology and Chronic Health Evaluation (APACHE) II score ≥ 10 (high risk patients).~      Patients will be enrolled in the trial, if they are ready to be discharged from the recovery~     unit or intensive/intermediate care unit to the surgical ward within 24 hours after surgery.~     Discharge criteria will be according to the Danish national recommendation.~      The intermediate care bed in the trial is defined by a certain minimum requirements to~     patient observation and described treatment possibilities which have to be available to the~     intermediate bed. If the treatment exceeds these treatment possibilities, the patient will be~     classified as an intensive care patient. The intermediate care bed will be placed at an~     intensive care unit, recovery unit or a surgical high dependency unit. If there is no~     available intermediate care bed, the patients will not be randomized, but only registered as~     excluded because of no available intermediate care bed.~      Hypothesis: Postoperative intermediate care for 48 hours or more will reduce the 30-day~     mortality in emergency abdominal surgery patients with a high risk of postoperative organ~     failure.~      Interim analysis: An independent Data Monitoring and Safety Committee (DMSC) will conducted~     the interim analysis based on the analysis of the primary outcome blinded for intervention~     allocation. The DMSC will use P<0.001 (Haybittle-Peto) on two subsequent interim analyses as~     the statistical limit to guide its recommendations regarding early termination of the trial~     for benefit or harm. The first interim analysis will be conducted when the 30 days follow-up~     data of about 50% (i.e., about 200 patients) of the trial participants have been obtained~     and/or 75 deaths have been documented during the trial. If P<0,001 in the first interim~     analysis a second interim analysis will be conducted when the 30 days follow-up data of about~     75% (i.e., about 300 patients) of the trial participants have been obtained and/or 25 deaths~     have been documented during the trial.~      Trial terminated on the 30th November 2012. The Data Monitor Committee found a very low~     overall event rate of the primary outcome at the first interim-analysis as compared to the~     pre-trial estimated. This precluding any possibility to detect or reject the anticipated~     relative risk reduction of 34 % as used in the sample size estimation.~   "
179945|NCT01209650|"~     The program will provide early access to the investigational drug BIBW 2992 to treat patients~     with advanced NSCLC who have failed at least 12 weeks on erlotinib or gefitinib.~      The Compassionate Use Programme will also provide additional safety and efficacy information~     on BIBW 2992 use.~      Named Patient Use (NPU)~   "
179946|NCT01209637|"~     Exercise training in patients with coronary artery disease is able to correct several risk~     factors. Furthermore endothelial function can be improved.~      There are some hinds for improved collateral circulation after exercise training,~     nevertheless there is no study showing significant improvement/ increase in coronary~     collaterals. This might be due to technique of collateral measurement. Therefore we conduct a~     study were coronary blod flow before and after 4 weeks of exercise training were measured.~   "
179947|NCT01209624|"~     The purpose of this study is to assess the long-term efficacy and safety of latanoprost~     monotherapy in patients with normal tension glaucoma (NTG) using a prospective, observational~     design. Visits were scheduled at 6-month intervals for 24 months. Intraocular pressure (IOP),~     optic nerve head findings, visual field status, and adverse events were recorded.~   "
179948|NCT01209611|"~     The purpose of this study is to evaluating whether autologous bone marrow mononuclear cells~     transplantation is safe and/or effective to accelerating skin regeneration and soft tissue~     expansion.~   "
179949|NCT01209598|"~     The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance)~     (formerly known as PD0332991) has on the patient and on the liposarcoma.~      Palbociclib is an investigational drug. An investigational drug is a medication that has not~     been approved for marketing by the Food and Drug Administration (FDA). Palbociclib blocks a~     protein called CDK4 which is part of a pathway in liposarcoma cells that is over-active. The~     investigators hope that blocking CDK4 will shut down this pathway in the liposarcoma cells~     and stop tumors from growing. Palbociclib is an oral medication.~   "
179950|NCT01209585|"~     The purpose of this study is to study the evaluation of blood samples and blood types to~     identify functional protein in the joints.~   "
179951|NCT01209572|"~     At this time, 24h energy expenditure is rarely assessed under free-living conditions for~     specific individuals because of the lack of cheap and accurate software/materials to record~     the energy expenditure. Some affordable and convenient tools (Polar heart rate monitor,~     Actiheart, SenseWear Armband) are available on the market but the predictive equations~     comprised into the software provided with these tools generally miscalculate the energy~     expenditure (by about +/-10%). Because of this deficiency, the investigators have a poor~     knowledge of the modification of the energy expended during daily life activities and over~     24h in subjects belonging to groups of various ages and physiological states. The~     investigators hypothesise that it could be possible to improve the energy expenditure~     prediction.~      The project aims at providing a mathematical model (equations) that predicts energy~     expenditure with an error near to 5%. Two groups of 60 sedentary to athletic normal weight~     volunteers aged between 18-60 years participate to this study. The first group stay for 26h~     in calorimetric chambers. During this stay energy expenditure ,heart rate, accelerometry, and~     other parameters are recorded during various activities. These data will serve to construct~     the model. The same type of recordings are performed on second group of volunteers in free~     living conditions. Their energy expenditure is measured overall by doubly labeled water. The~     data of the second group will serve to validate the model. The error percentage of the model~     is defined by the ratio of the value of the difference between prediction and reference~     measure to the reference measure. Concordance between predictions and measures will be~     evaluated by Bland - Altman plots.~   "
179952|NCT01209559|"~     The objective of this study is to determine if the glottic view obtained with the air-Q~     Intubating Laryngeal Airway (air-Q ILA, Cookgas LLC®, Mercury Medical®, Clearwater, FL, USA)~     is better than that obtained with the traditionally used intubating laryngeal mask airway~     (LMA FastrachTM or ILMA, LMA North America Inc., San Diego, CA). The study will also compare~     effectiveness of ventilation.~   "
179955|NCT01209520|"~     The trial investigates the feasibility and efficacy of targeting Non-Small Cell Lung Cancer~     (NSCLC) driven by epigenetic changes. The investigators study the impact of 5-azacitidine~     (Vidaza®, Celgene, Summit, NJ, USA) in combination with conventional cytotoxic chemotherapy~     in a sequential fashion. The study population consists of all NSCLC patients who undergo~     curative lung cancer resection and whose tumors harbor hypermethylation in any of the~     protocol-specific genes (samples will be banked for additional molecular testing including~     other 21 loci which have shown to be important in lung carcinogenesis.~   "
179956|NCT01209507|"~     Gynecologic Oncology patients have several different chemotherapy regimens, and dexamethasone~     is now routinely given to prevent allergic reactions to the chemotherapeutic agents. The most~     common chemotherapeutic agents used are paclitaxel and carboplatin. This combination regimen~     is given every three weeks for a total of 5-6 doses. Each dose is given after administration~     of 20 mg dexamethasone twelve hours prior to and the morning of chemotherapy. Dexamethasone~     is used for its antiemetic effects, but also to minimize the potentially fatal~     hypersensitivity reaction that can occur with paclitaxel. Another commonly used chemotherapy~     regimens is weekly cisplatin given with one dose of dexamethasone for cervical cancer.~     Chronic steroids are known to cause adrenal suppression, but it is not known if the amount of~     dexamethasone given with the gynecologic cancer chemotherapy regimens described above causes~     adrenal insufficiency in these patients. The investigators hypothesis is that some women~     receiving steroids with their chemotherapy may have adrenal insufficiency, and that they will~     have greater than normal chemotherapy-related fatigue.~   "
179957|NCT01209494|"~     The prospective EUTrigTreat multi-center study is an observational, advanced diagnostics and~     genetic risk stratification trial in patients with standard indications for ICD treatment,~     with and without myocardial infarction in their history.~      Its aims are fourfold: 1) To accurately risk stratify a large cohort of implantable~     cardioverter-defibrillator (ICD) patients for ICD shock risk and mortality using traditional~     risk markers as well as genetic markers 2) To find a link between repolarization biomarkers~     and genetic markers of calcium metabolism. 3) To compare invasive and noninvasive~     electrophysiologic (EP) testing systematically 4) To assess temporal changes of typical~     noninvasive risk stratifiers and their prognostic implication.~      In five European academic clinical centers, 700 ICD patients are prospectively enrolled~     (optionally the number of enrolled patients may be expanded to 1000 patients). Comprehensive~     non-invasive risk stratifying ECG diagnostics including beat-to-beat variability of~     repolarization (BVR) are applied, and candidate genes associated with malignant arrhythmias~     are analyzed. Programmed electrical stimulation is performed to test for inducibility of~     malignant ventricular arrhythmias and BVR. In a subset of patients, electrophysiologic~     studies include recording of monophasic action potentials (MAP) from the right ventricle for~     assessment of restitution properties. Non-invasive risk stratifying ECG methods are repeated~     annually. Outcome (mortality, ICD shocks) will be assessed until September 2014.~   "
179958|NCT01209481|"~     The right to food and nutrition is established in the Universal Declaration of Human Rights~     as they are basic requirements for promoting and protecting good health. They can also be~     instruments to evaluate the quality of life of human beings and communities. Awareness of a~     healthy diet is the first step in behavioral change, and nutritional education can be an~     instrument for avoiding diseases resulting from both intake deficit and excess. Educational~     group actions can change food intake. This study will aim at evaluating, planning and~     implementing the impact of a nutritional education group action concerning the consumption of~     fruit and vegetables in adult and elderly individuals attended to by a Primary Health Care~     (PHCU) Unit. It will be a randomized assay involving two groups comprising male and females~     individuals distributed in the following fashion: Intervention Group, in which the~     educational group action (EGA) will be performed in addition to routine activities; and~     Control Group, the individuals from which will only participate in the routine activities in~     the PHCA (Teaching Health Care Unit). The total sample will comprise 80 individuals with 40~     in each group. In order to determine the consumption of fruit and vegetables, a weekday and a~     Sunday 24-hour recalls will be performed 2 (short-term effects) and 6 (medium-term effects)~     months after completing the intervention. The educational group activities will consist of~     two-hour group dynamics and cooking workshops once a week and for five weeks. Serum~     carotenoid dosages will also be performed in the two groups by sub-sampling (n=40) with the~     purpose to validate the estimated intake of fruit and vegetables obtained from the recalls.~   "
179959|NCT01209468|"~     Obstructive sleep apnoea (OSA) is a serious and common disorder affecting one in twenty-five~     men and one in fifty women over the age of 30. This breathing abnormality occurs during sleep~     and is characterised by snoring and episodes of sleep disturbances. The symptoms of untreated~     OSA (e.g. excessive daytime sleepiness), can result in significant reductions in the~     patients' quality of life. The key treatment modalities today include Continuous Positive Air~     Pressure (CPAP), surgery and the use of oral appliances (OAs). Increasingly, OAs have been~     advocated in the treatment of the symptoms of OSA since they offer a non-invasive form of~     treatment and also because patients often prefer this treatment to other treatment~     modalities. There is increasing evidence to support the effectiveness of OAs in the~     management of OSA, at least as a short term measure. What is still unclear is which types of~     OA are most effective and whether OAs are effective in the long term management of OSA. This~     randomized clinical trial aims to evaluate two differently designed OAs in terms of their~     effect on patients' quality of life and on the physiological symptoms of OSA~     (apnoea/hypopnoea index AHI). Around 45 patients with OSA will be recruited from a pool of~     patients referred to the dental hospital for treatment from the medical faculty. The~     treatment with OAs will commence after randomization to two treatment groups; follow-up~     examinations will take place over a period of 12 months. The results of this study will help~     inform practitioners and patients of the feasibility of using OAs in the long term management~     of OSA and help determine the most appropriate type of OAs for the management of OSA and~     improvement in quality of life.~   "
180049|NCT01208272|"~     Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating~     disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but~     its long-term impact and time course on other BED-related symptoms remain largely unknown.~     This study compares the effects of group CBT and group IPT across BED-related symptoms among~     overweight individuals with BED.~   "
179960|NCT01209455|"~     Paracetamol overdose is the leading cause of acute liver failure in the Western World.~     N-acetylcysteine (NAC) has been the antidote of choice for over 30 years but its use is~     associated with adverse effects in 40% of cases. Patients characteristically experience~     nausea, vomiting and an anaphylactoid ('pseudo-allergic') syndrome. This reaction is~     clinically similar to true anaphylaxis (allergic reaction) including flushing, rash,~     constriction of airways, and a fall in blood pressure, but occurs via a different mechanism.~     Although treatable, these reactions lead to patient distress, commonly cause confusion among~     treating physicians, and lead to significant delays in antidote administration. The aetiology~     of these adverse reactions to NAC remains unclear. We hypothesise: i) these reactions result~     from a dose-dependent release of the chemical histamine, causing dilatation of blood vessels~     (vasodilatation) and the anaphylactoid syndrome; ii) paracetamol conversely exerts a~     protective effect on the reaction, with a less severe reaction observed in the presence of~     higher paracetamol concentrations. We will investigate the mechanisms underlying adverse~     reactions to NAC in the human forearm model, examining the role of histamine and other~     markers involved in the inflammatory process. The wider significance is an improved~     understanding of this poorly delineated phenomenon, with implications for other medications~     associated with similar reactions, such as non-steroidal anti-inflammatory drugs and opioids~     such as morphine.~   "
179961|NCT01209442|"~     The purpose of this study is to find out whether Hypofractionated Intensity-Modulated~     Radiation Therapy (Hypo-IMRT) combining with temozolomide chemotherapy can be safely given~     with a targeted agent, bevacizumab, and how effective this study treatment will be in~     controlling your brain tumor.~   "
179962|NCT01209429|"~     This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by~     that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men~     on calorie restriction on 4 study days with fat and skeletal muscle biopsies.~   "
179963|NCT01209416|"~     This study will investigate the non-growth-hormone-dependent metabolic effects of the hormone~     Ghrelin in growth hormone deficient subjects by examining the insulin tolerance as well as~     signal proteins in fat and muscle biopsies.~   "
179964|NCT01209403|"~     The purpose of this study is to investigate whether the anabolic potentials of insulin may be~     used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage~     renal failure.~   "
179965|NCT01209390|"~     The objective of this post-marketing study is to confirm the clinical efficacy and safety~     outcome of treatment with ChondroMimetic in a patient population within the proposed~     indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up~     period.~      The primary objective is to collect post-marketing safety data in a real life setting by~     means of (S)ADR reporting.~      The secondary objectives are:~        -  Clinical outcome as assessed by patient reported EuroQoL-5D~        -  Structural repair as assessed by MRI~        -  The number of treatment failures and the time to treatment failure~        -  The ease of use of ChondroMimetic as reported by the surgeon~   "
179966|NCT01209377|"~     EMDR (Eye Movement Desensitization and Reprocessing) is an exposure-based procedure for the~     treatment of patients with post-traumatic stress disorder (PTSD). Although the efficiency of~     EMDR-treatment is empirically proven, it remains unclear whether the bilateral stimulation~     triggered via eye movements has specific effects on treatment outcome. Hypothesis explaining~     the efficacy of the EMDR treatment are: focussing on the moving hand triggers an orientation~     reaction, and the duality of alertness focus during trauma exposition causes a distraction of~     the traumatic topic.~      Within a randomized controlled study 120 patients will be treated during 8 therapeutical~     sessions with EMDR with bilateral stimulation or one of two control conditions: EMDR without~     bilateral stimulation (eyes on a fixed, unmoving hand) and exposition without any visual~     stimuli to focus attention on. Primary outcome are scores on an interview measure for PTSD~     symptoms (Clinician Administered PTSD Scale (CAPS))as assessed pre-treatment and after~     treatment (max 8 sessions of psychotherapy).~      The following hypothesis are investigated in the study:~        1. EMDR treatment with bilateral stimulation through eye movements will be followed~          significant larger reduction in CAPS compared with EMDR treatment without bilateral~          stimulation (specific treatment effect of eye movements)~        2. EMDR with eyes fixed will be followed by a significant larger reduction in CAPS compared~          with EMDR without external focus (specific treatment effect of distraction)~   "
179967|NCT01209364|"~     The primary objective is to determine whether Durolane is non-inferior to methylprednisolone,~     as assessed by level of pain, when each are given as single intra-articular injections for~     the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.~   "
179968|NCT01209351|"~     The primary objective of this study is to assess the effects of 10 consecutive, daily,~     subcutaneous doses of 4 mg of teduglutide as compared with placebo on gastric emptying as~     assessed by acetaminophen absorption kinetics in healthy subjects.~   "
179969|NCT01209338|"~     The overall program goal is to determine the Acceptability and Feasibility of introducing a~     population based Human Papilloma Virus (HPV) Vaccination programme and understanding the key~     individual and community factors that would determine the potential acceptability of the~     vaccine.~   "
179970|NCT01209325|"~     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective~     immune response to prevent viral infection.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human~     papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.~   "
179986|NCT01209104|"~     GSK1325756 is a potent, competitive, selective and reversible CXCR2 receptor antagonist that~     is being developed as a once-daily oral anti-inflammatory medication for the treatment of~     chronic obstructive pulmonary disease (COPD). Selective antagonism of the interaction between~     CXCR2 and its various chemokine ligands is a potential strategy for reducing the underlying~     inflammation in COPD via the inhibition of neutrophil recruitment and activation. The current~     study explores the effects of age, gender and food (high fat meal) on the pharmacokinetics of~     GSK1325756.~      Because a significant proportion of COPD subjects are prescribed proton pump inhibitors~     (PPI's) such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux disease~     (GERD), it is important to understand the absorption of the current formulation of GSK1325756~     in an environment of raised intra-gastric pH as will be encountered in patients taking PPI's.~     Therefore, this study will also evaluate the impact of the proton pump inhibitor omeprazole~     on the pharmacokinetics of GSK1325756.~   "
179971|NCT01209312|"~     The investigators are hoping to figure out how youth with type 1 diabetes can best control~     their blood glucose levels after meals, by determining whether accurate carbohydrate dosing~     or the timing of the bolus is more important. There is evidence to suggest that each strategy~     is important for blood glucose control. Unfortunately, for some people, prebolusing is~     difficult, because they may not know how much they are going to eat. To give an exact dose of~     insulin 20 minutes before a meal can be difficult. In this study, the investigators would~     like to show that taking even just part of the insulin bolus 20 minutes before the meal is~     preferable to waiting until mealtime and taking the entire bolus. To do this, the~     investigators will have 24 patients in the study, who will each spend 4 mornings at The~     investigators clinic. The order of the visits will be selected randomly. The visits will~     include: taking full bolus at mealtime, taking full bolus 20 minute before mealtime, taking ½~     bolus at mealtime, and taking ½ bolus 20 minutes before mealtime. At each visit, the person~     will eat the same meal, but the timing and amount of the bolus will be different. The~     investigators will measure the blood glucose levels with a blood glucose meter, and also with~     a laboratory test called YSI. The investigators will also be measuring the glucose levels~     under the person's skin with a continuous glucose monitor. The investigators will compare the~     area under the curve for the different visits, as well as the glucose levels at different~     points after the meal.~   "
179972|NCT01209299|"~     RATIONALE: Studying samples of tissue in the laboratory from patients receiving carboplatin~     and paclitaxel with or without sorafenib tosylate may help doctors learn more about the~     effects of this treatment on cells. It may also help doctors understand how well patients~     respond to treatment.~      PURPOSE: This research study is studying biomarkers in predicting response to chemotherapy in~     patients with advanced or metastatic melanoma previously treated with carboplatin and~     paclitaxel with or without sorafenib tosylate.~   "
179973|NCT01209286|"~     The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab~     is effective, safe and tolerable in the treatment of patients with relapsed/refractory~     B-precursor ALL.~   "
179974|NCT01209273|"~     The objective of this study is to compare Quality of Life (QoL) between Automated Peritoneal~     Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD).~   "
179975|NCT01209260|"~     This is a randomized controlled trial examining whether a mechanical needle versus a needle~     that uses radiofrequency energy is better at puncturing through a thin wall in the heart~     (called transseptal puncture) as measured by procedure time, during an electrical~     procedure/study of the heart .~   "
179976|NCT01209247|"~     The emergence of resistance to fluoroquinolone (FQ) is a major problem worldwide. The~     commensal flora is the main reservoir for antibiotic resistance. Understanding the factors~     (environmental, patient-related, dosis-related, drug-related…) involved in the emergence of~     resistance to fluoroquinolones in the commensal flora of patients treated with a FQ, may help~     prevent it and preserve the efficiency of these important antibiotics. Samples of rectal,~     nasal and pharyngeal flora will be collected from hospitalized patients before receiving a~     FQ, at the end of the treatment and 1 month after the end of treatment. Clinical data will be~     collected. The incidence and risk-factors associated with the emergence of resistance to FQ~     will be assessed by comparing groups with and without resistance both at the end of treatment~     and 1 month later.~   "
179977|NCT01209234|"~     This randomized controlled trial will compare strategies to reduce the risk of~     methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA~     carriers. This trial will provide critical answers about the role of decolonization versus~     standard-of-care education in preventing MRSA infections in the large group of high risk~     MRSA-positive patients being discharged from hospitals. Findings could potentially impact~     best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each~     year.~   "
179978|NCT01209221|"~     This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate~     the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses~     of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a~     single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983~     or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks~     for the SAD part and up to 8 weeks for the MAD part.~   "
179979|NCT01209208|"~     The purpose of this study is to determine whether budesonide or mesalazine is more active in~     the treatment of lymphocytic colitis.~   "
179980|NCT01209195|"~     This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in~     combination with paclitaxel using a 3+3 design.~   "
179981|NCT01209169|"~     The purpose of this study is to collect blood and urine samples that may help identify and~     validate biomarkers for the early detection and risk assessment of acute kidney injury (AKI).~   "
179982|NCT01209156|"~     The underlying goal of this study is to assess PBR-111 positron emission tomography (PET)~     imaging as a tool to detect microglial activation in the brain of Alzheimer disease (AD)~     research participants and age- and gender-matched healthy volunteers.~   "
179983|NCT01209143|"~     This is a single-arm, multicenter, Phase Ib study designed to describe the effect of GDC-0449~     on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with advanced~     solid tumors who are refractory to treatment or for whom no standard therapy exists.~   "
179984|NCT01209130|"~     This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S administered~     by intravenous (IV) infusion to patients with relapsed or refractory hematologic~     malignancies. In addition, at selected sites, DCDT2980S will be studied in combination with~     rituximab.~   "
179985|NCT01209117|"~     This is a single-center, randomized, two part, open-label, crossover study in healthy adult~     subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet~     formulations manufactured by three different processes relative to the GSK2248761 WBM capsule~     formulation (Part A) and the effect of a moderate-fat meal on the bioavailability of the~     selected WBM tablet formulation (Part B).~   "
180050|NCT01208259|"~     Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating~     disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but~     its long-term impact and time course on other BED-related symptoms remain largely unknown.~     This study compares the effects of group CBT and group IPT across BED-related symptoms among~     overweight individuals with BED.~   "
179987|NCT01209091|"~     Introduction: Many reimbursement authorities use economic evaluation to help guide decisions~     regarding the adoption of new treatments in reimbursement systems. Survival and quality of~     life are often the main measure of benefit used in an economic evaluation - expressed as a~     quality adjusted life year (QALY). In addition though, some decision makers will also~     consider the impact of a treatment on a patient's ability to continue working (expressed in~     terms of productivity). The aim of the present study is to estimate quality of life weights~     (utilities) and productivity loss for women with metastatic breast cancer (Human Epidermal~     Growth Factor Receptor 2 positive or HER 2+).~      Methods: Separate surveys will be used to assess utilities and productivity in HER2+~     metastatic breast cancer (MBC). To capture utilities health state descriptions or vignettes~     describing progressive disease, stable disease, and seven grade 3/4 adverse events~     (diarrhoea, fatigue, anaemia, leukopenia, anorexia, decreases in left ventricular ejection~     fraction (LVEF), and skin rash) will be developed. The vignettes will be developed based on a~     literature review and in depth interviews with women with MBC in the Netherlands and Sweden.~     Clinical experts in both countries will review the health states for content validity. The~     health states will be translated using forward and back translation. Members of the general~     public will rate the states (100 men and women in NL; 100 women aged 50+ in Sweden) using the~     visual analogue scale and Time Trade Off method to determine utility values. In a separate~     survey women who are currently being treated or have recently completed their treatment for~     MBC will be surveyed regarding the impact of disease on their ability to work using a~     validated work productivity measure (Work Productivity and Activity Impairment) in women in~     the Netherlands and Sweden.~   "
179988|NCT01209078|"~     This study will determine the safety, tolerability and efficacy of GSK1322322 verses~     Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).~   "
179989|NCT01209065|"~     GSK1349572 is an integrase inhibitor being developed for the treatment of human~     immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV~     HealthcareLLC. In HIV-infected patients where combination antiretroviral therapy is the~     standard of care, it is likely that it will be dosed with boosted protease inhibitors (PIs)~     including fosamprenavir/ritonavir (FPV/RTV or FPV/r). As FPV and RTV are modulators~     (induction as well as inhibition) of Uridine diphosphate glucuronosyltransferase (UGT) and~     Cytochrome P450 (CYP)3A which are the primary and secondary metabolic pathways of GKS1349572,~     it is likely that FPV/RTV will affect the pharmacokinetics (PK) of GSK1349572, therefore a~     drug interaction study is warranted and will be evaluated in Part A of this study. Part B~     will evaluate the effect of particle size of tablet variants on the PK of GSK1349572.~      In Part A, approximately 12 subjects will receive GSK1349572 50mg every 24 hours (q24h) for 5~     days (Treatment A). Subjects will then be administered GSK1349572 50mg q24h in combination~     with FPV/RTV 700/100 mg every 12 hours (q12h) (Treatment B) for 10 days. There will be no~     washout between treatments. In Part B 15 subjects will receive a single 50 mg dose (2 x 25mg~     tablet) in 3 different tablet variants of the same formulation, differing only in particle~     sizes of GSK1349572, under fasted conditions in a three-way crossover design. Safety~     evaluations and serial PK samples will be collected during each treatment period. A follow-up~     visit will occur 7-14 days after the last dose of study drug.~   "
179990|NCT01209052|"~     This study aims to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single, oral ascending doses, and repeat oral doses of GSK1325756~     administered to healthy adult male volunteers. This study is the First Time in Human study~     for GSK1325756.~   "
179991|NCT01209039|"~     This study described in the present protocol consists of two parts. Part A is a multiple~     ascending dose study to evaluate the safety, tolerability and pharmacokinetics of ascending~     doses of GSK1144814. Part B is an open label design in healthy male subjects to assess the~     GSK1144814 Neurokinin1 receptor occupancy.~   "
179992|NCT01209026|"~     A randomised, placebo controlled thorough QTc study to evaluate the effect of repeat dose~     FF/GW642444M combination, with moxifloxacin as a positive control, on the QTc interval in~     healthy male and female subjects. Key assessments will include 12- lead electrocardiogram~     (ECG) and pharmacokinetic (PK) parameters, along with safety being assessed by blood~     pressure, heart rate, clinical laboratory safety tests, and collection of adverse events.~   "
179993|NCT01209013|"~     Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a~     non heated laser. The activation of the drug is done by lighting of abnormal areas using a~     fiber optic device. The fiber optic device is a very fine fiber (like a fishing line) that~     permits transmission of light. The fiber optic device is inserted into a diffusing balloon~     device to ensure the good positioning of the fiber optic within the esophagus (food pipe). It~     is thought that the size and the flexibility of a new diffusing balloon device could improve~     the safety profile of the photodynamic treatment by reducing the risk of narrowing or closure~     of the food pipe (esophageal stenosis) sometimes occurring after treatment.~      This research study will evaluate the safety and effectiveness of PDT with porfimer sodium~     using a new diffusing balloon device for light application in the removal of high-grade~     dysplasia (HGD, precancerous change in the food pipe tissue) in Barrett's esophagus (BE).~     This study will provide advanced knowledge about phototoxicity (reaction similar to sunburn)~     and esophageal stenosis, main risks with this therapy. It will involve 75 patients with HGD~     in BE across North America and Europe and will last between 13 and 16 weeks. In addition,~     concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of~     patients.~   "
179994|NCT01209000|"~     Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous~     nephropathy (MN), generate an enormous individual and societal financial burden, accounting~     for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual~     cost in the US of more than $3 billion. However, the clinical classification of these~     diseases is widely believed to be inadequate by the scientific community. Given the poor~     understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies~     are imperfect. The therapies lack a clear biological basis, and as many families have~     experienced, they are often not beneficial, and in fact may be significantly toxic. Given~     these observations, it is essential that research be conducted that address these serious~     obstacles to effectively caring for patients.~      In response to a request for applications by the National Institutes of Health, Office of~     Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a~     number of affiliated universities joined together with The NephCure Foundation the NIDDK, the~     ORDR, and the University of Michigan in collaboration towards the establishment of a~     Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.~      Through this consortium the investigators hope to understand the fundamental biology of these~     rare diseases and aim to bank long-term observational data and corresponding biological~     specimens for researchers to access and further enrich.~   "
179995|NCT01208987|"~     The investigators plan to develop a process to create an Enhanced Medication List. The INPC~     (Indiana Network for Patient Care) already obtains histories of medications dispensed by~     pharmacies from several sources: pharmacy benefit managers, RxHub, insurance companies,~     Medicaid, SureScripts, Wishard Health Services. The investigators will collect all the~     medication data available through the INPC for an individual patient. The investigators will~     enhance this medication list by including medication categories, improving the structure and~     appearance, displaying results of relevant laboratory tests, and adding decision support~     reminders. The investigators will test the value of such an Enhanced Medication List by~     providing it to outpatient physician practices (through the DOCS4DOCS clinical messaging~     service, or as a fax), preferably on the day that the patient has an office visit with the~     physician. The investigators will determine whether this intervention improves patient care:~     whether there are higher rates of recommended laboratory follow-up monitoring as a result;~     whether there are lower rates of harmful drug-drug interactions. The investigators will also~     seek the opinions of physicians regarding the benefit of this intervention.~   "
179996|NCT01208974|"~     Overall rationale: Prophylactic NAC irradiation after nipple-areola sparing mastectomy and~     immediate reconstruction for patient with ductal carcinoma in-situ or invasive breast cancer~     will allow better cosmesis and patient's satisfaction:~        -  The use of NAC-sparing mastectomy followed by postoperative NAC (nipple-areola complex)~          external beam radiotherapy for selected patient with early stage invasive or in-situ~          breast cancers will be technically feasible and with acceptable complication rates.~        -  The cosmetic results after NAC-sparing mastectomy followed by postoperative external~          beam radiotherapy to the NAC will be better comparable with Skin Sparing Mastectomy.~        -  The local control rate in the NAC will be more than expected for a NAC sparing~          mastectomy without postoperative radiotherapy.~        -  The patient's satisfaction after NAC-sparing mastectomy followed by postoperative NAC~          external beam radiotherapy will be better than after Skin Sparing Mastectomy.~   "
179997|NCT01208961|"~     The objectives of this study are to compare the relative bioavailabilities of~     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of~     Epanova or Lovaza during periods of high- and low -fat consumption.~   "
179998|NCT01208948|"~     To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular~     edema.~   "
179999|NCT01208935|"~     The purpose of this study is to test the safety, tolerability, compliance and efficacy of two~     different forms of nicotine replacement therapy (NRT) (the nicotine transdermal patch and the~     nicotine gum) in a nicotine-dependent adolescent population.~   "
180000|NCT01208922|"~     The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus~     Ciprofloxacin for the treatment of adults with traveller's diarrhoea.~   "
180001|NCT01208909|"~     In the treatment of glioblastoma (GBM) neurosurgical resection of the tumor is usually~     considered a a first step of effective therapy. Radical resection of the tumor is highly~     beneficial to the patient as measured in progression-free survival and overall survival. At~     the same time eloquent areas of the brain have to remain intact to preserve quality of life.~      Both 5-ALA fluorescence and intraoperative MRI are used for intraoperative marking of tumor~     tissue and thereby to improve precision of GBM-Resection.~      We now study whether the combination of 5-ALA fluorescence and intraoperative MRI increases~     the number of sites where tumor tissue can be detected.~      - Trial with surgical intervention~   "
180002|NCT01208896|"~     This trial will evaluate the efficacy and the safety of a strategy of allogeneic stem cell~     transplantation including Rituximab in the conditioning regimen for the treatment of relapsed~     follicular lymphoma. The rationale for using Rituximab relies on a better control of the~     disease and a better prophylaxis of the graft versus host disease.~   "
180003|NCT01208883|"~     Treatment adaptation to biological and anatomical changes occurring during treatment can~     increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer~     patients. This trial investigates the feasibility of using repetitive per-treatment~     [18F]FDG-PET acquired during treatment in adaptive [18F]FDG-PET-voxel intensity-based~     intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head~     and neck cancer.~   "
180004|NCT01208870|"~     The purpose of this center grant is to translate basic behavioral science on habituation~     theory into clinical intervention using a vertical hierarchical approach from laboratory~     studies to field studies to the clinical intervention to improve weight loss outcomes in~     pediatric obesity treatment.~   "
180005|NCT01208844|"~     The purpose of this study is to obtain a better understanding of how stress is related to~     health risks.~   "
180006|NCT01208831|"~     The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase~     II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e.,~     Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite~     standard therapy or for which no standard therapy exists.~   "
180007|NCT01208818|"~     MYRE is a phase III multicentric controlled national clinical trial conducted in patients~     with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims~     are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with~     cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not~     requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to~     biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using~     either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional~     high-flux dialyser, while receiving chemotherapy with BD.~   "
180008|NCT01208805|"~     The study first aim is to investigate the relationship between different patterns of~     electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to~     optimize spinal cord stimulation parameters . The second aim of the study is to investigate~     the role of the spinal cord in some aspects of cognitive-sensory-motor processing,~     specifically the presence of top-down attentional effects on the sensory analysis of an~     external stimulus at the spinal cord level.~      The study will be performed on patients that will be implanted with a spinal epidural~     electrode because of chronic intractable pain. From these electrodes, spinal cord evoked~     potentials (SCEPs) will be recorded.~   "
180009|NCT01208792|"~     The investigators have recently evidenced the presence of antibodies to endothelial cells and~     fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also have~     identified several target antigens of anti-fibroblasts antibodies.~      The objective of this study is to further investigate for the presence of antibodies to~     endothelial cells and fibroblasts in patients and characterize the antigen specificity of~     autoantibodies in patients with different types of non idiopathic and non SSc-associated PAH,~     such as PAH associated with HIV infection, porto-pulmonary hypertension, congenital heart~     diseases, systemic lupus erythematosus, mixed connective tissue disease and Sjögren's~     syndrome~   "
180010|NCT01208779|"~     This observational study in estrogen receptor positive early breast cancer patients is aimed~     to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect~     country-specific data in estrogen receptor positive early breast cancer patients including~     data on demography, disease characteristics and disease management.~   "
180011|NCT01208766|"~     Study phase: phase III~      Study objective:~        -  Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed~          autologous stem cell transplantation (ASCT)~        -  Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no~          consolidation~        -  Comparison of single versus tandem high dose Melphalan with ASCT~      Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS~     stages 1-3, age 18-65 years inclusive~      Study design: Prospective, multicenter, intergroup, randomized~      Duration of treatment: Expected duration of induction, stem cell collection and~     intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance~     therapy with Lenalidomide will be given until relapse. All patients will be followed until 10~     years after registration.~   "
180012|NCT01208753|"~     The purpose of the study is to evaluate the safety and tolerability of multiple ascending~     oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and~     to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous~     suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and~     pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.~   "
180013|NCT01208740|"~     Metformin should be administered with caution and could be potentially dangerous in infertile~     patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based~     ovarian stimulation. However, data that address this point are totally lacking.~      On the basis of these considerations, the aim of the current clinical trial was to test the~     hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who~     have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF~     cycles.~   "
180014|NCT01208727|"~     After having shown that postconditioning allowed a significant 36% reduction of infarct size~     as assessed by blood levels of myocardial enzymes in acute myocardial patients, the~     investigators objective is to assess the effect of postconditioning in acute myocardial~     infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.~   "
180015|NCT01208714|"~     Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT).~     Since there are still uncertainties as to whether and in what patients revascularization by~     means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study~     exploiting an optimized patient selection strategy and using hard experimental endpoints to~     unravel these uncertainties.~      Primary objective: to determine if revascularization by means of PTRAS is superior or~     equivalent to optimal medical treatment for preserving glomerular filtration rate in the~     ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan.~      Secondary objectives: to determine if the two treatments are equivalent in lowering blood~     pressure (BP), preserving overall renal function and regressing damage in the target organs~     of hypertension.~      Design: prospective multicenter randomized, unblinded two-arm study.~      Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral~     RAS, defined by stenosis of the proximal portion of the renal artery and its main~     bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could~     bias the assessment of the outcome of revascularization.~      Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT~     either > 70% or, if < 70 with post-stenotic dilatation.~      Renal function will be assessed with 99mTc-DTPA renal scintigraphy.~      Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference~     in means of GFR in the vascularized (or control untreated kidney) of 7.5 ml/min.~      Arms~        1. Revascularization: digital scan angiography and PTA with stenting of the renal artery at~          the ostium or at truncular level, plus optimal medical therapy.~        2. Medical therapy: the drug regimen that had been optimized during the run-in period.~      Experimental endpoints:~      The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as~     quantitative variable and compared between groups at each time point. A categorical~     definition of kidney loss, defined as a GFR in the ischemic kidney of < 5 ml/min, will be~     also used and the rate of achievement of such endpoint will be compared.~      Duration: 5 years.~   "
180016|NCT01208701|"~     It has been documented that statin reduce mortality and morbidity in patients with~     cardiovascular disease. This effect can partly be related to a reduction in cholesterol~     levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as~     nephropathy, diabetes and hypertension. The purpose of this study is to investigate the~     effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular~     variables in patients with type 2 diabetes with nephropathy.~   "
180017|NCT01208688|"~     The main objective of this study is to determine the effectiveness of a new treatment regime~     that uses electrical stimulation for the improvement of hand function in persons with spinal~     cord injuries (SCI). This treatment has been shown to be useful for stroke patients, and our~     preliminary work indicates that this may also be the case with SCI patients. Our approach to~     functional electrical stimulation (FES) represents a departure from the established FES~     approaches, which involve developing assistive devices for permanent, everyday use. Instead,~     we use FES as a therapeutic intervention that will help individuals with quadriplegia recover~     voluntary grasping function. Investigators believe that subjects who undergo FES therapy~     should be able to grasp objects without stimulation once the treatment program is completed.~   "
180045|NCT01208324|"~     The aim of this study is to examine the effects of estrogen and serotonin on cognition,~     emotional processing, and brain activation. The investigators will study the effects of acute~     tryptophan (TRP) depletion on cognition and mood in healthy menopausal women before and after~     estrogen replacement treatment (ERT). Using functional magnetic resonance imaging (fMRI), the~     investigators will identify differences in brain activation during memory tasks with and~     without TRP depletion and before and after estrogen therapy in order to determine which brain~     regions and cognitive functions are affected by each manipulation.~   "
180046|NCT01208311|"~     The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C~     patients with advanced fibrosis, using endoscopic ultrasound.~   "
180047|NCT01208298|"~     The primary objective of this study was to evaluate the safety and performance of a cold sore~     patch for the treatment of herpes labialis.~   "
180018|NCT01208675|"~     The present study aims at combining biochemical methods with various types of imaging~     techniques to identify the pathophysiology of Alzheimer's disease (AD). The main interest is~     to find markers associated with the very early steps in the pathology of this disease. The~     investigators shall thus screen for i) molecules in cerebrospinal fluid (CSF) and plasma~     specific for AD, and ii) brain imaging markers (e.g. MRI and PET) that correlate to detailed~     clinical assessments.~      Biomarkers of interest would then be useful to:~        1. Enable accurate detection of the disease early on. Such biomarkers need to specifically~          reflect the very early pathophysiology of AD and distinguish it from disorders with~          similar symptomatology, such as other types of dementia and major depression. The~          sensitivity and specificity of these biomarkers in combination with clinical assessment~          should be of at least 90%.~        2. Enable prediction of the course of events of the disease, such as the disease rate in~          individual patients. Biomarkers that can predict the pattern of future symptoms will be~          extremely valuable.~        3. Allow monitoring of early effects of new disease-modifying therapies (so-called~          surrogate biomarkers). Currently clinical therapeutic trials for AD require large~          patient groups together with long-term treatment. Both size of the groups and treatment~          time will be reduced with the help of surrogate biomarkers.~        4. Study the pathogenesis of the disease. Biomarkers can be used to investigate in detail~          early alterations in AD patients. For instance, changes in the levels of certain~          molecules in CSF together with genetic predisposition could then be correlated to~          clinical signs and changes detectable by brain imaging. This can lead to identification~          of new therapeutic targets that could easily be monitored in future trials.~   "
180019|NCT01208662|"~     The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the FDA. They have~     not been approved in the combination for multiple myeloma or any other type of cancer.~     Bortezomib is currently approved by the FDA for the treatment of multiple myeloma.~     Lenalidomide is approved for use with dexamethasone for patients with multiple myeloma who~     have received at least one prior therapy and for the treatment of certain types of~     myelodysplastic syndrome (another type of cancer affecting the blood). Dexamethasone is~     commonly used, either alone, or in combination with other drugs, to treat multiple myeloma.~     Please note that Bortezomib and Lenalidomide are provided to patients participating in this~     trial at no charge. Melphalan and cyclophosphamide, the drugs used during stem cell~     collection and transplant, are also approved by the FDA. Melphalan is an FDA-approved~     chemotherapy for multiple myeloma and is used as a high-dose conditioning treatment prior to~     stem cell transplantation. Cyclophosphamide is used, either alone, or in combination with~     other drugs, to treat multiple myeloma. These drugs have been used in other multiple myeloma~     studies and information from those studies suggests that this combination of therapy may help~     to treat newly diagnosed multiple myeloma.~      In this research study, we are looking to explore the drug combination, lenalidomide,~     bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation~     to see what side effects it may have and how well it works for treatment of newly diagnosed~     multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of~     novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple~     myeloma in younger patients. In this study, HDT as compared to conventional dose treatment~     would be considered superior if it significantly prolongs progression-free survival by at~     least 9 months or more, recognizing that particular subgroups may benefit more compared to~     others.~   "
180020|NCT01208649|"~     The primary objective is to test the hypothesis that 24 weeks of treatment with exenatide~     will improve the histological acitvity of NASH (steatosis,necroinflammation, ballooning),~     summarized in the recently introduced NASH-score in patients with normal, impaired or~     diabetic glucose tolerance compared to dietary guidance alone.~   "
180021|NCT01208636|"~     The purpose of this study is to determine the effect of environmental and genetic influences~     on Vitamin D status.~   "
180022|NCT01208623|"~     Patients with chronic lower limb edema commonly suffered from extremities edema, pain,~     varicosities, venous stasis changes, and deep venous thrombosis. A common challenge for~     primary care physicians is to determine the cause and find an effective treatment for leg~     edema of unclear etiology. The aims of this project are to determine the cause of patients~     with chronic lower limb edema with conventional digital venography, the clinical value of~     role of 3D rotational venography or combined multidetector (MD)CT angiography and iliac~     venography using direct iliac venography for contrast administration via bilateral femoral~     catheterization (MDCT angiography/venography) with volume-rendering images supplementary to~     2D digital venography in evaluation of patients with chronic lower limb edema.~      This project is designed as retrospective cross-sectional study. Between April 2008 and Dec~     2009, a total of approximately 300 patients with chronic lower limb edema who had had~     bilateral iliac digital venography and surgery at our institution will be reviewed. All~     patients underwent surgery by one senior vascular surgeon for lower limb conditions within~     one month after the venographic examination. Patients who had incomplete clinical and~     surgical records or incomplete images will be excluded. The surgical findings of the~     presence, anatomical location, and size of the venous narrowing will assessed and described.~     Stenosis was defined as luminal narrowing of 50% or more compared to the prestenotic or~     poststenotic lumen.With use of surgical findings as a the standard, the investigators~     calculated and compared the diagnostic accuracies, sensitivities, specificities, positive~     predict values and negative predict values of 2D digital venography images alone, 3D~     rotational venography, and combined MDCT angiography/venography with volume-rendering images~     supplementary to 2D digital venography.~      With this large series study, the investigators believe that the cause of chronic lower leg~     edema in our patients' population will be clarified. The value of additional 3D rotational~     venography, and combination MDCT angiography/venography with volume-rendering images will~     lead to higher diagnostic performance and may provide a helpful tool for planning surgical~     and endovascular treatment, which has not been reported before.~   "
180023|NCT01208610|"~     The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About~     Pregnant Women's Service Quality and Satisfaction~   "
180024|NCT01208597|"~     Owing to its image resolutions and its convenience in diagnosis, both better than abdominal~     ultrasound, transvaginal ultrasound is nowadays widely applied in diagnosing practice in~     obstetrics and gynecology. As a result, female examinees who undergo these check-up~     procedures have to expose their private parts, instead of their abdomens like the old days.~     According to the literature, women who receive transvaginal ultrasound check-ups normally~     have anxiety reactions, and worry about pain and discomfort. In clinical practice, when~     giving advice to the examinees to go through this check-up, more than often the diagnosis~     itself is its sole purpose, and little psychological assistance is offered. Traditional~     clinical space and disposal process tend to be designed to serve the purposes of conforming~     to the customs of medical staff and to the integrity of human resources and facilities in the~     hospital managers' minds, and less frequently tend to take the needs of patients into~     consideration. Consequently these patients are forced to enter strange medical environments~     and accommodate to the existent medical systems, with physical and psychological discomforts,~     to suffer from even more uncomfortable and anxiety-causing check-ups. Current medical service~     is required to not only provide a clean environment, but also give attention to creating an~     artistic space to increase healthy factors to the environment. The literature points out that~     a comfortable and artistic space can eliminate environmental strangeness, and help patients~     to soothe their pressures caused by their own and by the environment.~   "
180025|NCT01208584|"~     The purpose of this study is to use functional MRI (fMRI) and magnetic resonance (MR)~     diffusion tensor imaging (DTI) to investigate brain activation and white matter changes in~     patients with congenital (birth defect of the spinal column), acute and chronic complete~     spinal cord lesions. The findings of this study may provide a basis to better understand the~     pathomechanisms underlying the dynamic neurofunctional changes following a spinal cord~     lesions in man. This understanding is important for the improvement of existing therapies and~     for the development of new therapeutic approaches.~   "
180026|NCT01208571|"~     The effect of alcohol interventions seems to be related to the intensity of the~     interventions. In this study the investigators will assess the effect of a interdisciplinary~     booster session in primary care, given to patients who were admitted to hospitals with~     alcohol related conditions, and who were given Brief Intervention before discharge. The~     booster session is based on a motivational interview.~   "
180048|NCT01208285|"~     The purpose of this study is to investigate the pharmacokinetics and safety of a single dose~     of VX-770 in subjects with moderate hepatic impairment.~   "
180027|NCT01208558|"~     The main purpose of this 2-year lifestyle experiment for waist loss is twofold:~        1. to compare whole grains and no grains as part of a healthy diet,~        2. to determine if an 8-week exercise program, led by physiotherapists, is more efficient~          than brief counseling and follow-up.~      People with abdominal overweight (≥84 cm in women and ≥98 cm in men) and at least one~     additional cardiovascular risk factor, (typically hypertension, diabetes type 2 or prior~     cardiovascular disease) are randomly assigned to receive Diet A or Diet B, with or without a~     structured exercise program at the department of physiotherapy, or to a control group~     receiving usual care. Diet A and B both include fruit, vegetables, fish, meat, and low-fat~     dairy products, and differ only in that Diet A recommends exchange of cereal grains for more~     potatoes, root vegetables, fruit and other carbohydrate-rich foods, while Diet B recommends~     exchange of regular cereal grains for whole grains. The primary outcome (most important~     follow-up variable) is change in waist circumference during 2 years. Secondary outcome~     measures include blood pressure, blood lipids, level of physical activity and, in subjects~     with diabetes, glycated hemoglobin and fasting blood sugar.~   "
180028|NCT01208545|"~     The study hypothesis is that changes in serially obtained nerve conduction study data~     obtained every 3-4 weeks in cancer patients receiving chemotherapy can be used to predict the~     development of a clinically significant / disabling drug induced neuropathy six and twelve~     months following the start of treatment. Patients with breast cancer, colon cancer,~     gastroesophageal cancer, and non-Hodgkins lymphoma will be enrolled. Six lower extremity~     nerves--three in each leg--will be electrically stimulated and their responses recorded at~     three to four week intervals coinciding with patient's scheduled chemotherapy.~   "
180029|NCT01208532|"~     The aim of this study is to evaluate the reliability and validity of the Korean version of~     the European Organization for Research and Treatment of Cancer High-dose Chemotherapy module~     (EORTC HDC-29).~   "
180030|NCT01208519|"~     The study is the WP4 of the EU-funded (7th FW) project SATURN (Impact of Specific Antibiotic~     Therapies on the prevalence of hUman host ResistaNt bacteria). A total of 6 surgical and 6~     medical wards will participate in the study. Sites of the study are located in 3 countries~     (Italy, Serbia, Romania). This WP will compare nosocomial acquisition rates of~     methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum beta-lactamase~     (ESBL)-producing gram-negative bacteria (E.coli, Klebsiella spp. and Proteus spp.) among~     different treatment groups and define the temporal relationship between the start of~     antibiotic therapy, the acquisition of new colonisation in patients previously not colonised,~     and the development of a bacterial infection caused by the same strain isolated in a~     screening sample. This goal will be achieved by completing the following primary objectives:~        -  To determine the rate of acquisition of target antibiotic-resistant bacteria by 1,000~          antibiotic-days according to different classes of antibiotics, duration of therapy and~          antibiotic combination (monotherapy versus combination therapy);~        -  To determine genotypic relation between colonising and infecting strain in the same~          patient and patients' and hospital staff colonising strains (to be performed in~          collaboration with WP1 of the SATURN project);~        -  To study the virulence and fitness of the isolates (i.e. new colonising strains) causing~          subsequent nosocomial infections (to be performed in collaboration with WP1 of SATURN~          project);~        -  To predict the risk for nosocomial infections due to target bacteria after a single~          treatment therapy adjusted by length of hospitalisation and ward colonisation pressure.~   "
180031|NCT01208506|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability, pharmacokinetic (the effect of the body on the investigated drug),~     pharmacodynamic biomarkers (biomarkers related to anti-IL-21 expected mode of action) and~     signs of clinical efficacy of increasing single doses, at 9 i.v. (into the vein) dose levels~     in Healthy Subjects , at 3 i.v. dose levels in subjects with rheumatoid arthritis (RA) and at~     3 s.c. dose levels in Healthy Subjects.~   "
180032|NCT01208493|"~     In this randomized study The investigators aim to compare the growth of very-low-birth-weight~     (VLBW) infants fed either a high protein or a standard protein preterm infant formula.~      Babies will be fed the assigned formula between the time they achieve full enteral feeds and~     hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and~     compared between groups. Feeding tolerance, protein-energy status and body composition~     between the study groups will also be analysed.~      After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between~     hospital discharge and 3 m corrected age.~   "
180033|NCT01208480|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving bevacizumab together with~     docetaxel and carboplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel~     and carboplatin works in treating women with operable Stage II or stage III breast cancer.~   "
180034|NCT01208467|"~     This research study is studying prognostic biomarkers in tissue samples from patients with~     endometrial cancer. Studying samples of tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~   "
180035|NCT01208454|"~     This phase I trial is studying the side effects and the best dose of vorinostat when given~     together with isotretinoin to see how well it works in treating patients with high-risk~     refractory or recurrent neuroblastoma. Vorinostat may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Isotretinoin may help vorinostat work~     better by making tumor cells more sensitive to the drug. Giving vorinostat together with~     isotretinoin may be an effective treatment for neuroblastoma.~   "
180036|NCT01208441|"~     This phase I trial is studying the side effects and best dose of RO4929097 when given~     together with letrozole in treating post-menopausal women with stage II or stage III breast~     cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving~     RO4929097 together with letrozole may be an effective treatment for breast cancer.~   "
180037|NCT01208428|"~     Duke University Medical Center in collaboration with Glendale Adventist Medical Center~     propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs.~     religious cognitive behavior therapy (RCBT) for major depression in medical patients with~     chronic disabling illness. Therapists will deliver the treatment in real time over the~     Internet and/or by telephone to increase treatment access. This planning grant seeks support~     for a two-site study (North Carolina and California) that consists of two phases. In Phase I~     (Rounsaville 1a) the investigators will conduct an open trial of 30 patients to assess~     subject recruitment, refine RCBT and CCBT manuals and protocol, assess compliance with~     treatment, acceptability of treatment and delivery system (online vs. telephone), and allow~     therapists gain experience with delivery system and RCBT.~      In Phase II (Rounsaville 1b) the investigators will conduct a randomized proof of concept~     comparison of CCBT vs. RCBT that will demonstrate feasibility and confirm the expected~     clinically meaningful difference for a definitive R01 application. In Phase II, 70 religious~     patients ages 18-85 with a new episode of major depression (MINI), scores of 16-35 on the~     Beck Depression Inventory (BDI), and at least one chronic disabling medical illness will be~     randomized to either CCBT or RCBT. The trial will consist of ten 50 min sessions administered~     by master's level therapists and delivered over 12 weeks. The primary endpoint will be BDI~     score at baseline, 4, 8, 12, and 24-week follow-up. Christian, Jewish, Hindu, Buddhist, and~     Muslim versions of the RCBT manual will be developed, and CBT experts in each of these~     traditions will supervise therapists delivering the intervention to patients from these faith~     traditions.~      The purpose of this study is to determine feasibility and effect sizes for a future, fully~     powered treatment study. The importance is that results will be relevant to therapists well~     beyond those who explicitly practice pastoral counseling, extending to many secular~     therapists as well. If 65% of Americans indicate that religion is an important part of daily~     life and the vast majority of chronically ill medical patients wish to include it in their~     therapy, then all therapists (whether they have explicit training in pastoral counseling or~     not) are likely to encounter patients in which this approach would be applicable.~   "
180038|NCT01208415|"~     The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the~     safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in~     combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the~     treatment of aorto-iliac and iliac aneurysms.~   "
180039|NCT01208402|"~     The purpose of this study is to find out if Esmolol is a safe and effective alternative~     treatment compared to standard treatment using a long acting beta blocker drug, in~     controlling abnormal heart rate before, during and immediately after surgery.~   "
180040|NCT01208389|"~     The study is a follow-on to a Phase 1 dose-escalation and safety study.~   "
180041|NCT01208376|"~     Little is known about the clinical significance of chronic alanine aminotransferase (ALT)~     elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first~     to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with~     chronic ALT elevation and no chronic viral hepatitis using non-invasive diagnostic tests and~     second to find associated factors with significant fibrosis and cirrhosis. In a second~     longitudinal part we intend to assess fibrosis progression within 1 and 3 years.~   "
180042|NCT01208363|"~     Rationale: Iron deficiency and zinc deficiency, are of public health significance in~     sub-Saharan Africa. An estimated 50% of children (5-14 years) in developing countries suffer~     from anaemia, half of which is estimated iron deficiency anaemia. Interventions have been~     designed and implemented over the years towards solving hunger and anaemia especially among~     school age children. One of such interventions is School Feeding Programme (SFP) which is~     common in both developing and industrialized countries. SFP has been part of the Ghanaian~     educational system for well over 40 years, albeit on small scale. The main stay of the~     programme that makes it distinguishable from other past and existing school feeding~     programmes is its reliance on locally produced and available foods, such as cowpeas. Legume~     staples like cowpea have been identified to be important sources of protein and non-heme iron~     to rural populations of developing countries like Ghana. The problem however is the low~     bioavailability of these micronutrients from these legumes.~      Objective: To assess the efficacy of iron fortified cowpea based meal (Tubani) in improving~     iron status of primary school children in rural northern Ghana Study design: A randomized~     double blind parallel design will be conducted. One group will receive iron fortified Tubani~     with NaFeEDTA and the other group will receive unfortified Tubani.~      Study population: Two hundred and forty apparently healthy pupils in lower primary school~     will participate. The participating schools have a school feeding programme currently in~     operation.~      Intervention (if applicable): Children will be fed Tubani containing 10mg of fortification~     iron (in the form of NaFeEDTA) three times in a week for six months. Weight, height and blood~     samples will be measured at baseline and after six months of intervention. Participants will~     be treated against intestinal parasites before start of intervention and halfway through the~     intervention.~      Main study parameters/endpoints: The main study endpoint is iron-deficiency anaemia (IDA).~     IDA will be defined as concurrent anaemia and iron deficiency. Whole blood will be collected~     for the analysis of Hb, serum ferritin (SF), serum transferring receptor (sTfR) and~     C-reactive protein (CRP). Anemia will be defined as a hemoglobin concentration <115 g/L, and~     iron deficiency will be defined as an SF concentration <12 µg/L.~      Venipunctures occasionally lead to bruises or small local inflammation which usually~     disappear within one week. To minimize this risk, blood collection will be performed by a~     trained and experienced phlebotomists. Written informed consent will be obtained from all~     subjects.~   "
180043|NCT01208350|"~     This is a 3-arm pilot randomized controlled trial to evaluate the effectiveness of two novel~     ways of structuring financial incentives to motivate and sustain long-term weight loss. The~     study will recruit eligible employees at Children's Hospital of Philadelphia (CHOP) to~     participate in a 6-month weight loss program and an additional 3-month follow-up period. The~     primary outcome measure in this randomized control trial will be pounds of weight lost~     between baseline and 6 months. The goal of this study is to evaluate whether a novel~     financial incentive program delivered through a workplace can effectively encourage sustained~     weight loss among obese employees.~      The study hypotheses are 1) mean weight loss will be greater in all the intervention groups~     compared to the control group by the end of the 24-week intervention period; and 2)~     individuals in the intervention groups will have a lower mean weight at the end of the~     12-week follow-up period than individuals in the control group.~   "
180044|NCT01208337|"~     This open-label clinical trial will evaluate the safety and efficacy of Alemtuzumab (Campath,~     Bayer Corp., Pittsburgh) in children (0-17) and adults (18-25) receiving intestinal~     transplant. Seventy-five subjects receiving primary or repeat intestine transplantation will~     be enrolled. Primary endpoints include the incidence and severity of biopsy-proven acute~     cellular rejection, the incidence of freedom from steroids at 5 years, and the incidence of~     subjects with steroid-free Tacrolimus at whole blood concentrations < 10 ng/ml. Secondary~     endpoints include a) incidence and severity of opportunistic infections (CMV and EBV),~     post-transplant lymphoproliferative disorder (PTLD), and chronic rejection b) use of~     non-immunosuppressive co-medications, c) time to repopulation of all lymphocyte subsets, d)~     longitudinal characterization of donor-specific alloreactivity in mixed lymphocyte responses~     (MLR), to identify the time at which it decreases to a level less than third-party-specific~     alloreactivity e) longitudinal expression (mRNA) of genes, to identify rejection- and~     non-rejection-specific genes and f) characterization of whole genome mutations, which show~     differences in parent-to-child transmission between rejectors and non-rejectors. This will~     identify rejection- and non-rejection-specific genes bearing genetic variants, which might~     impact on gene function, and complement candidate gene identification efforts based on SNP~     transmission.~   "
181871|NCT01184287|"~     The purpose of the trial is to determine the rate of improvement in objective tumor response,~     following the addition of ranpirnase to ongoing pemetrexed—carboplatin chemotherapy, for~     patients with SD or PR following 2 cycles of doublet chemotherapy.~   "
180052|NCT01208233|"~     The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following~     multiple dose administration to subjects with ischemic stroke. The study will also evaluate~     the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following~     90 days of therapy. The study will also explore the relationship between PF-03049423~     concentration and blood pressure.~   "
180053|NCT01208220|"~     Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a~     device which by themselves are effective for the treatment of wounds.~      You are being asked to take part in this study because you have a wound on your body which~     has not responded to standard treatments.~      The researchers will be studying whether the combination of two treatments will make wounds~     heal faster. For those in study, the investigators will treat them with a vacuum device on~     their wound. Also, some of the people in the study will receive a special ointment and~     researchers will use special tests to determine if the two treatments together are working~     better than just one treatment alone.~   "
180054|NCT01208207|"~     The purpose of the study is to evaluate the efficacy and tolerability of two doses of~     etoricoxib compared to naproxen in the treatment of ankylosing spondylitis (AS). The primary~     objectives are to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment~     with etoricoxib 90 mg or 60 mg compared to naproxen; and to evaluate the improvement in~     Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg compared with~     etoricoxib 60 mg. Additionally the added benefit of increasing the dose of etoricoxib from 60~     mg to 90 mg will be assessed in the second part of the study. The primary hypothesis is that~     the improvement in Spinal Pain Intensity visual analog scale (VAS) as measured by the~     time-weighted average (TWA) change from baseline over 6 weeks of treatment in Part I for~     etoricoxib 90 mg or 60 mg once daily is not inferior to naproxen 1000 mg.~   "
180055|NCT01208194|"~     This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy~     and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo~     control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC~     Stage IV) with disease control after first-line standard chemotherapy regimens.~   "
180056|NCT01208181|"~     This is a 2-part (6 weeks duration for each part), randomized, double-blind,~     placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that~     etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to~     placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline~     in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater mean~     improvement in Patient Global Assessment of Pain (PGAP) from baseline over 6 weeks of~     treatment. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to~     90 mg will be assessed in the second part of the study.~   "
180057|NCT01208168|"~     The objectives of this study are to assess the safety of NAB001 for topical treatment of mild~     to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of~     NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.~   "
180058|NCT01208155|"~     Study in healthy males to assess bioavailability of 4 different fostamatinib tablets~   "
180059|NCT01208142|"~     The purpose of this study is to examine the change in ankle plantar flexion while walking,~     following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as~     Toe Walkers.~      For twelve weeks, patients will either receive the standard treatment or the same standard~     treatment and the Dynaslint worn at night.~   "
180060|NCT01208129|"~     The objectives of this study are to assess the safety of NAB001 for topical treatment of mild~     to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of~     NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.~   "
180061|NCT01208116|"~     The purpose of this study is to determine whether non-invasive atherosclerotic measurements~     (baPWV, IMT, FMD, CACS, ABI) are valuable predictors for cardiovascular events in elderly. At~     inception, routine physical examination and non-invasive atherosclerotic measurements will~     conducted on all participants. Then they will be followed prospectively for at least 2 years.~     All cardiovascular and other health events will be recorded.~   "
180062|NCT01208103|"~     The goal of this clinical research study is to learn if the combination of capecitabine,~     oxaliplatin, and bevacizumab can help to control cancer of the small bowel or ampulla of~     Vater. The safety of this drug combination will also be studied.~   "
180063|NCT01208090|"~     This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in~     patients with moderate-to-severe chronic plaque psoriasis.~   "
180064|NCT01208077|"~     This multinational registry (3 USA, 2 European centers) will capture in the ED continuous non~     invasive hemodynamic monitoring (using Nexfin finger cuff technology) of patients presenting~     with acute heart failure, stroke syndromes and systemic infection. Patients will be observed~     after their Emergency Department (ED) disposition to determine clinical outcomes (length of~     stay in the hospital, the development of any organ dysfunction, mortality and need for~     unscheduled medical care within the ensuing 30 days). It is anticipated that specific ED~     hemodynamic profiles will be predictive of better clinical outcomes than others. This~     information will provide the outcome data needed to design future therapeutic trials that~     will evaluate the effect of ED hemodynamic manipulations on overall patient management and~     outcomes.~   "
180065|NCT01208064|"~     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known~     whether pazopanib hydrochloride is more effective than a placebo in treating patients with~     non-small cell lung cancer that has not progressed after first-line chemotherapy.~      PURPOSE: This randomized phase II/III trial is studying how well giving pazopanib~     hydrochloride works and compares it with giving a placebo in treating patients with non-small~     cell lung cancer who have received first-line chemotherapy.~   "
180066|NCT01208051|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     cediranib maleate when given together with or without lenalidomide and to see how well they~     work in treating patients with thyroid cancer. Cediranib maleate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the~     growth of thyroid cancer by blocking blood flow to the tumor. It is not yet known whether~     cediranib maleate is more effective when given together with lenalidomide in treating thyroid~     cancer.~   "
180067|NCT01208038|"~     A woman's ovaries produce the hormone testosterone during her reproductive life but~     testosterone levels decline with age or when the ovaries are removed. Testosterone has been~     associated with sexual desire in both men and women. Low testosterone is also believed to~     cause symptoms of low energy. Thus testosterone is increasingly used in hormone replacement~     regimens to restore libido and energy in postmenopausal women.~      In the past testosterone has been administered orally or via subcutaneous implants. Recently~     testosterone patches have been licensed for treating low libido in postmenopausal women. The~     testosterone patches deliver a dose of testosterone equivalent to the levels produced by the~     ovary during a woman's early reproductive years.~      Oral testosterone can lead to changes to insulin and cholesterol levels which increase the~     risk of heart disease. On the contrary, testosterone patches may reduce or avoid this risk.~     To date, trials have predominantly focused on safety data in terms of side effects and basic~     blood tests. Reviews of the safety of testosterone replacement have emphasised the need for~     improved safety data, especially in terms of cardiovascular risk.~      The purpose of this study is to examine the effect of the testosterone patch, in addition to~     hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.~      The investigators hypothesis that transdermal testosterone, in addition to HRT, will have no~     adverse effects on blood vessel walls and insulin levels and that transdermal testosterone~     significantly improves sexuality and psychological well-being in postmenopausal women.~      Trial design:~      The investigators aim to recruit 20 postmenopausal women to wear the testosterone patch for 3~     months in addition to their usual hormone replacement therapy.~      There will be 3 study visits - a pre study visit, week 6 and week 12. At each visit the~     following procedures will be performed:~        -  Medical history and physical examination~        -  Blood sample - for hormone levels, lipids and insulin levels~        -  Blood vessel stiffness measurements This will be performed using a small ultrasound~          device at the wrist with blood pressure measured every 5 minutes.~        -  Endothelial function (function of your arterial wall) is measured using a blood pressure~          cuff on each arm and finger probes on one finger of each hand. The blood pressure cuff~          is inflated for 5 minutes and is then deflated quickly. The finger probes will record~          the readings throughout this study.~        -  Sexual satisfaction questionnaire~   "
180068|NCT01208025|"~     The possibility of the identification of the risk of rupture of a carotid plaque will have~     tremendous impact in clinical decision making. Firstly, in symptomatic patients with a 30-69%~     stenosis, who are currently not operated upon according to the current guidelines,~     identification of the risk of rupture plaque could identify patients who have a high risk of~     recurrent stroke, and would benefit of carotid intervention, such as endarterectomy or stent~     placement. This could potentially prevent a substantial number of strokes. Secondly, in all~     symptomatic patients with a 70-99% stenosis carotid intervention should be considered,~     according to the guidelines. However, only one out of six patients with a 70-99% stenosis~     benefits from a carotid intervention. Identification of patients with a high risk of a~     recurrent stroke would reduce the number of unnecessary interventions substantially.~      The main objective is to show whether imaging characteristics assessed at baseline can~     predict clinical events in patients with a 30-69 % symptomatic carotid stenosis.~   "
180069|NCT01208012|"~     The trial is a phase IV clinical trial investigating the impact of Liraglutide on endothelial~     function and microvascular blood flow in 44 patients with type 2 diabetes mellitus aged 30-65~     and HbA1c ranging from ≥ 5.5% ≤ 7.0%. The patients will be randomized into two study arms,~     one arm will be treated with Metformin monotherapy, the second arm will be treated with~     Metformin and Liraglutide at an increasing dose (0.6 mg/day to 1.8 mg/day.)~   "
180070|NCT01207999|"~     The aim of the study is to assess the distribution of the most frequent types of human~     papillomavirus in African women diagnosed with invasive cervical cancer.~   "
180071|NCT01207986|"~     Early Lung Cancer diagnosis in a HIV-infected population with an important smoking history~     with low-dose CT: a pilot study: the HIV-CHEST study Objectives The main objective of this~     study is to evaluate the prevalence of lung cancers detected by low-dose computed tomography~     (CT) in a HIV-infected population with an important smoking history. Other objectives are (1)~     the evaluation of the types of lung cancers in this population, as well as (2) the staging of~     non small cell lung cancers, (3) the description of risk factors for all lung cancers, if~     they are numerous enough, and (4) the number of complications of diagnosis procedures during~     the study.~   "
180072|NCT01207973|"~     The objective of the study is to investigate the safety and tolerability of BI 113823 in male~     and female patients with osteoarthritis, following oral administration of BI 113823 with~     repeated rising doses.~   "
180073|NCT01207960|"~     The purpose of this study is to find out whether Eye Movement Desensitization and~     Reprocessing (EMDR) is effective in the treatment of patients with dental phobia.~   "
180074|NCT01207947|"~     Main object is to investigate the safety profile of Levitra in combination use with~     alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.~      In the initial combination date and the first and second observation after initial~     combination date, number of tablets prescribed, dose of tablets and number of tablets taken~     until follow-up visit will be investigated. The efficacy and tolerability will be evaluated~     at 2 months after initial combination date.~   "
180075|NCT01207934|"~     Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not~     known whether it improves insulin action in persons who are not leptin deficient. The purpose~     of the present study was to determine whether leptin therapy has effects on insulin action in~     obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial~     was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to~     treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.~   "
180076|NCT01207921|"~     The purpose of this study to evaluate the feasibility of lenalidomide maintenance therapy in~     patients with relapsed Hodgkin lymphoma after autologous transplant~   "
180077|NCT01207908|"~     The purpose of this study is to determine whether IGF-1 therapy improves or preserves muscle~     function in Duchenne Muscular Dystrophy (DMD).~   "
180078|NCT01207895|"~     The purpose of this study is to determine if positron emission tomography (PET) imaging with~     an imaging agent called 18F-fluorodeoxythymidine([18F]-FLT) will allow investigators to~     measure how well tumor(s) respond to treatment without taking a tissue sample (biopsy).~     Additionally, the investigators want to determine if it is possible to predict how well~     tumor(s) might respond to treatment with [18F]-FLT PET imaging.~   "
180079|NCT01207869|"~     Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth~     arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely~     premature infant with severe BPD to establish whether intratracheal instillation of umbilical~     cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.~   "
180080|NCT01207856|"~     Despite the need for cognitive rehabilitation, there is a paucity of well-designed research~     studies to investigate treatment approaches or their effectiveness in MS. Most of published~     studies suffer from significant methodological flaws including small sample size, short~     follow-up periods, and lack of specific outcome criteria to determine improvement. O'Brien et~     al. (2008) recently reviewed 16 studies of cognitive rehabilitation designed to persons with~     MS and found only 4 class I studies and only one class I study of rehabilitation of attention~     deficits. Methodologically rigorous research is needed to confirm the preliminary results~     reported by these studies and determine the effectiveness and efficacy of cognitive~     rehabilitation interventions in attention deficits in MS. O'Brien et al. listed limitations~     found in previous studies that must be addressed in future studies. The present study was~     designed according to these recommendations. It is a randomized, controlled study, in~     parallel groups, evaluator blinded.~      Number of participants: 25 RRMS patients in the active group, 25 RRMS patients in the control~     group and 25 healthy subjects.~      The protocol will be proposed to RRMS patients AFFILIATED TO FRENCH SOCIAL SECURITY referred~     to the investigators center by practicing neurologists and fulfilling the inclusion criteria~     for screening.~      Patients will be randomised between two groups. The active group (25 patients) will be~     treated by rehabilitation. Individual rehabilitation procedures will be focused on attention,~     executive functions and IPS. The program will be tailored to each patient cognitive status~     depending on the impairments identified during the initial assessment while maintaining a~     systematic work on attention and executive functions. A total of 50 sessions lasting one hour~     at a rate of 3 sessions per week for a total period of 4 months will be proposed. Patients~     randomized in the other group will participate to group session every week without specific~     cognitive rehabilitation. 25 healthy control subjects (group C), matched to patients for~     education, gender and age with patients of groups A/B will have the same evaluation~     procedures than patients.~      Evaluation will be performed at baseline, after 4 months (end of treatment period) and after~     8 months. Evaluation will include clinical testing, cognitive battery (paper/pencil and~     computer tests), cognitive ecological evaluation (Computer test of attention in a virtual~     reality environment and driving test on a driving simulator), questionnaires about daily life~     and MRI (fMRI and MRI). All patients and healthy subjects will undergo the fMRI protocol~     using a paradigm previously published by the investigators group (Bonnet et al., 2009):~     Go/No-go paradigm with increasing difficulty during four successive conditions (the Tonic~     Alertness task, Go/No-go (IG), reversal Go/No-go (RG), and complex Go/No-go (CG). In a~     previous study the investigators observed compensatory activation in MS patients as compared~     to healthy controls for the three first conditions and a saturation of compensatory processes~     for the more complex. In the present study, the investigators hypothesize that a similar~     pattern will occur at baseline and that cognitive rehabilitation will improve brain~     compensation at the fourth level of complexity.~   "
180104|NCT01207544|"~     Children with developmental coordination disorder (DCD) often have poor postural control and~     motor skills that affect their activities of daily living and participation in school~     activities. The aim of this randomized controlled trial is to compare the effects of fitball~     training versus task-oriented motor training for children with DCD.~   "
180081|NCT01207843|"~     Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy~     for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans,~     but there is no standardized CT protocol for the diagnosis and follow-up of hepatic~     candidiasis.~      The investigators compared the size of the fungal lesions in the chest and abdomen CT. The~     current analysis aimed to increase the value of CT for the diagnosis and the follow-up of~     hepatic candidiasis in daily routine.~   "
180082|NCT01207830|"~     The purpose of this study is to provide initial clinical data to support the feasibility of~     use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in~     morbidly obese subjects~   "
180083|NCT01207817|"~     The purpose of this study is to determine the effects of varying luminescent levels on the~     pupillary response.~   "
180084|NCT01207804|"~     The purpose of the study is to provide initial clinical data to support the feasibility of~     use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in~     morbidly obese patients.~   "
180085|NCT01207791|"~     Misuse of drugs and alcohol has a tremendous impact on individual health and on society, in~     terms of both human suffering and economic cost. Most substance abusers never seek specialty~     addiction treatment, but a large percentage of them receives some form of medical care,~     frequently in emergency room settings. There is considerable evidence showing that Screening,~     Brief Intervention, Referral, and Treatment (SBIRT) interventions in medical settings result~     in decreased drinking and alcohol-related problems among those with alcohol abuse or~     dependence. However, there are few studies using these models focusing on drug users.~     Although drug users are seen in large numbers in emergency departments, there have been no~     randomized controlled trials of SBIRT models for drug users presenting in Emergency~     Departments (EDs).~      This study is designed to assess the effects of Assessment, Referral, and a Brief~     Intervention on substance use of individuals screening positive for drug use during a medical~     ED visit. The Southwest Node of the NIDA Clinical Trials Network, located at UNM CASAA, is~     taking the lead on this study. Six sites across the country will participate in this study,~     including the ED of UNM Hospital. A total of 1285 ED patients who screen positive for current~     drug use problems will be randomly assigned to receive 1) minimal screening only, 2)~     assessment of substance use and referral to treatment, or 3) assessment and referral combined~     with a 30-minute counseling session (Brief Intervention) and two follow-up telephone~     counseling sessions. Outcomes will be assessed at 3, 6, and 12 months after the ED visit. We~     hypothesize that those who receive the Brief Intervention will have the least drug use at~     follow-up, that those who receive minimal screening only (the usual current practice) will~     have the most drug use, and that those receiving assessment and referral without the Brief~     intervention will have intermediate outcomes.~   "
180086|NCT01207778|"~     Approximately 60,000 premature infants are born each year who weigh less than 1,500~     grams,many of whom sustain brain damage because of their prematurity. This study is designed~     to evaluate the long-term developmental effects of one promising neuroprotective~     treatment,erythropoietin (Epo), when given in the neonatal period. Using detailed~     neurodevelopmental testing and state-of-the-art brain imaging, we hope to determine whether~     this is an effective treatment to prevent brain injury associated with prematurity, and to~     lay the groundwork for further studies to improve the developmental outcome of infants~     delivered prematurely.~   "
180087|NCT01207765|"~     The study involves the use of a targeted form of radiation, in addition to standard high dose~     chemotherapy and stem cell transplant for multiple myeloma. The use of targeted radiation is~     designed to kill more multiple myeloma cells while avoiding the side effects of standard~     radiation. This type of targeted radiation (also known as radioimmunotherapy) has been~     approved by the Food and Drug Administration (FDA) for the treatment of a related disease,~     lymphoma under the trade name, Zevalin©. Zevalin© has been added to high dose chemotherapy~     and stem cell transplants for patients with lymphoma and is now being studied in this~     clinical trial for patients with multiple myeloma. This trial is only available at Tufts~     Medical Center.~      The proposed clinical trial will test whether CD20-targeted radio-immunotherapy can be safe~     and effective when integrated into a standard regimen of myeloablative chemotherapy and~     autologous stem cell rescue in patients with measurable disease prior to high dose~     chemotherapy and autologous stem cell transplant for multiple myeloma.~   "
180088|NCT01207752|"~     The aim of this study will be to determine the efficacy of this novel, lipid-containing~     artificial tear on the signs and symptoms of meibomian gland disease.~   "
180089|NCT01207739|"~     The purpose of the study is to establish whether prolonged antibiotic treatment of patients~     diagnosed with proven or presumed PLD (as endorsed by the international ILADS guidelines)~     leads to better patient outcome than short-term treatment as endorsed by the Dutch CBO~     guidelines.~   "
180090|NCT01207726|"~     This study combines the deoxyribonucleic acid (DNA) methyltransferase inhibitor,~     5-azacitidine (5-AZA), with an orally bioavailable histone deacetylase inhibitor, entinostat~     (SNDX-275), for the adjuvant treatment of patients with resected stage I non-small cell lung~     cancer (NCSLC).~   "
180091|NCT01207713|"~     To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing~     surgical technique in hydroxyapatite orbital implants~   "
180092|NCT01207700|"~     This is a randomized, open trial comparing post discharge interventions by community health~     workers (CHW) to standard care in acute coronary syndrome (ACS) patients.~      This trial will be conducted in 10 hospitals in India/different parts(both secondary and~     tertiary care). A total of 800 patients will be recruited, with equal allocation to SPREAD~     interventions and control groups (usual care)~   "
180093|NCT01207687|"~     People who have neurofibromatosis type 2 (NF2) can have tumors that grow on the auditory~     nerves and cause hearing loss. These tumors are called vestibular schwannomas (VSs), or~     acoustic neuromas. People with NF2 can also get schwannomas in other parts of their body, as~     well as tumors called meningiomas and ependymomas. Because VSs can cause hearing loss, many~     people with NF2 will have treatment to preserve their hearing. This treatment usually~     involves surgery. Because surgery has risks and is not able to help everyone with VSs, other~     methods of treatment are being explored. One area of exploration is looking to see if there~     is a drug that can be taken that might prevent the VSs from growing larger and causing~     hearing loss or brainstem compression. This study is exploring whether a drug that is~     approved by the FDA and is currently used to treat other tumors might also work to treat VSs.~     Based on people who have taken this drug to treat VSs already, there is some reason to think~     that it might be helpful to certain people with NF2. People enrolled in this study will~     receive the drug one time every three weeks for one year by infusion. This study will follow~     subjects over the course of the year that the person is taking the drug and for six months~     after the drug is stopped. This study is recruiting people who have NF2 and are currently~     having symptoms of tinnitus, dizziness, and/or hearing loss from their VSs. If you have NF2~     and are currently having symptoms caused by your VSs, you may be eligible to participate.~   "
180094|NCT01207674|"~     This study is divided into two stages. The first stage is a transversal study and corresponds~     to the recruitment of participants, which will last about two years. Three groups of gamblers~     will be constituted : Non-problematic gamblers (NPG), Problematic gamblers Not in Care (PGNC)~     and Problematic gamblers in Care (PGC).The second stage is a prospective 5-year follow-up~     study of the cohort (only the initial NPG and PGNC groups are concerned by the follow-up~     study), that consists on an annual follow-up evaluation. The main objective of the first~     stage of the study is to compare the characteristics of the three groups of gamblers on some~     socio-demographic and clinical data. These comparisons will allow us to identify, among all~     data, those that will be most likely to explain the evolution of the practice of gambling~     (appearance or resolution of a gambling problem), and recourse to specific care. These such~     isolated data will be tested in the second stage of the study, in order to determine those~     that are predictive factors of three steps of the gambling course of some gamblers :~     evolution of a controlled gambling practice into a problematic gambling practice, resolution~     of the problematic gambling practice without intervention of care, and first recourse to~     specific care.~   "
180095|NCT01207661|"~     Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in~     terms of social and economic, are palliative and do not contemplate healing by regenerative~     therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in~     vitro and may regenerate several damaged or injured tissues. In addition its has demonstrated~     that MSC are able to modulate immune responses and to control inflammation through its action~     on T lymphocytes. Preliminary studies in animal models, including one carried out in an~     equine by the investigators research group, confirms feasibility, safety and efficacy~     evidence proposed treatment protocol.This study is designed to evaluate therapeutic potential~     and safety of mesenchymal stem cells in improvement of osteoarthritis clinical~     manifestations.This study is designed to evaluate therapeutic potential and safety of~     mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.~   "
180096|NCT01207648|"~     The aim of this retrospective study is to review and describe safety, tolerability and~     efficacy of Rebif® (subcutaneous interferon [IFN]-beta-1a) in children and adolescents, using~     information already recorded in medical records. The study duration is 13 July 2010 (first~     data collected) to 13 July 2011 (last data collected). In this study, Data of the subjects~     evaluated between 1997 and 2009 was observed.~   "
180097|NCT01207635|"~     The goal of this study is to evaluate antiproliferative effects of Arimidex in ductal lavage~     fluids of Breast Cancer patients.~      Breast cancer is the leading cause of cancer incidence and the second leading cause of cancer~     mortality in women. Breast duct fluid provide biomarkers to aid in risk assessment of~     developing breast cancer.~   "
180098|NCT01207622|"~     The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in~     the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD)~     with comorbid Substance Use Disorder (SUD). The secondary objective of the study is to~     determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has~     demonstrated that ATMX has led to significant improvement in ADHD in children and lacks abuse~     liability, the investigators hypothesize that ATMX will be efficacious in treating ADHD in~     adolescents and young adults with SUD, and that ATMX will also be efficacious in preventing~     SUD relapse.~   "
180099|NCT01207609|"~     The purpose of this study is to collect data prospectively on the safety and efficacy of the~     Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.~      The 95% confidence interval for average percentage of weight loss and body mass index will be~     computed at 6 months, one year and then annually. Analysis of comorbid conditions changes,~     quality of life and adverse events will be performed. With 50 subjects in the study, limited~     power is expected and no formal hypothesis testing will be performed.~   "
180100|NCT01207596|"~     The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with~     neuropathic pain.~   "
180101|NCT01207583|"~     This study is planned to monitor the local and/or systemic reactions and compatibility of~     PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with~     the observational nature of this protocol, Prevenar will be administered as standard of care.~      The aim of this study is to estimate the incidence of febrile reactions more than 38.0~     degrees Celsius, specifically (≥38 to < 39 degrees C; > 39 to < 40 degrees C and > 40 degrees~     C, and the frequency of other local or systemic reactions following vaccination with Prevenar~     (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine~     daily use in the Russian Federation.~   "
180102|NCT01207570|"~     Children with developmental disabilities often sustain decreased range of motion in their~     extremities. The decrease in flexibility may be due to neuromuscular disorders such as~     spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint,~     leading to inappropriate habitual posture. Over time, muscle contracture may result for those~     muscle groups that are placed in a shortened position for an extended period of time. The~     most common site of muscle contractures among these children are gastrocnemius/soleus (lower~     limbs), and latissimus dorsi muscles (upper limbs). Muscle contractures can lead to further~     decline in functional abilities. Therefore, it is important to identify effective~     intervention strategies to enhance or maintain muscle flexibility in children with~     developmental dysfunctions.~      Commercially available endermotherapy device has been used to soften scar tissue following~     burn injuries. The mechanical stimulation applied may also have beneficial effects on~     relaxing the muscle tissue. The overall aim of the proposed study is to determine whether~     endermotherapy treatment has immediate effect in improving joint range of motion among~     children with developmental disabilities.~      The research hypothesis is that children in the endermotherapy group will have significantly~     more gain in ankle passive range of motion than those in the control group.~   "
180103|NCT01207557|"~     The purpose of this study is to determine whether, among healthcare personnel who are~     undecided about whether to receive influenza vaccine, does use of the OIDA increase or~     decrease their confidence in their decision to be immunized? Furthermore, does the use of the~     OIDA affect the intent of the healthcare personnel to be immunized or not immunized?~   "
181804|NCT01185171|"~     The purpose of this study is to explore the activity of ZD1839 added to concurrent~     chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck~     cancer. Activity is described in terms of response rate (complete responses only).~   "
180105|NCT01207531|"~     Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and~     treatment directly affect the survival rate. MiRNA is a post-transcriptional small RNA which~     regulate mRNA expression. The present study was designed to screen several miRNA by~     microarray which evaluate the sepsis prognosis in order to be a new target for the treatment~     of sepsis.~   "
180106|NCT01207518|"~     During the 2010-2011 and the 2011-2012 seasonal influenza immunization campaigns, we will~     recruit a minimum of 46 healthcare organizations to either conduct their campaigns as usual~     or to use the Successful Influenza Immunization Campaigns for Healthcare Personnel: A Guide~     for Campaign Planners and a web-based grab-and-go Tool Kit. At the end of the campaign season~     we will evaluate the impact of the Guide and web-based tools and assess whether there were~     changes in immunization rates within each organization and/or if there were significant~     changes in the management of the campaigns across organizations.~      Following completion of the study, we will work with partner organizations to make these~     tools available to all Canadian healthcare organizations.~   "
180107|NCT01207505|"~     Psychoeducation has been the only group treatment developed for bipolar disorder thus far.~     Deficits in emotion regulation, a core impairment among patients with bipolar disorder, are~     not directly addressed in this treatment. The objective of this study is to develop a group~     treatment for bipolar disorder that focuses on emotion regulation strategies (Enhancing~     Emotion Regulation; EER). This study will examine the efficacy of this treatment using an~     open trial design. It is hypothesized that patients who receive EER will show a reduction in~     mood symptoms and improvement in well-being. Reductions in emotion regulation difficulties~     will predict improvements.~   "
180108|NCT01207492|"~     Nilotinib is a drug that is used to treat a form of a blood cancer called leukemia. Nilotinib~     works by blocking the action of a protein that might be important for the growth of pigmented~     villonodular synovitis (PVNS). In this research study the investigators are testing whether~     nilotinib can stop the growth of PVNS or improve the symptoms experienced from PVNS.~   "
180109|NCT01207479|"~     This is a non-randomized, open-label, multi-center clinical study to be conducted at~     approximately 5 investigative sites in the US that have expertise in the healthcare~     management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current~     moldable users while the remaining users can be non-moldable users if moldable users can not~     be enrolled.~   "
180110|NCT01207466|"~     The purpose of this trial is to compare the performance of two contact lenses for contact~     lens wearers with astigmatism.~   "
180111|NCT01207453|"~     The purpose of this study is to determine whether milnacipran reduces widespread, non-joint~     pain in patients with rheumatoid arthritis (RA). The investigators will conduct a~     double-blind randomized crossover trial in subjects with RA to test the hypothesis that~     milnacipran improves widespread, non-joint pain. The investigators will also use data from~     the trial to determine whether response to milnacipran is associated with pain-modulating~     mechanisms from the central nervous system. The investigators hypothesize that response to~     milnacipran will be greater among patients with impaired central pain mechanisms than among~     patients with intact central pain modulating mechanisms.~   "
180112|NCT01207440|"~     The purpose of this study is to determine the efficacy of ponatinib in patients with chronic~     myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or~     with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or~     intolerant to either dasatinib or nilotinib, or have the T315I mutation.~   "
180113|NCT01207427|"~     Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and~     reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI~     tract. The most common symptoms associated with the effects of opioids are constipation and~     nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of~     long-term opioid therapy.~      The primary objective of this study was to compare ADL5945, a MOR antagonist, with placebo in~     the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy~     for chronic noncancer pain.~   "
180114|NCT01207414|"~     Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult~     subjects with schizophrenia who require a change in their current antipsychotic treatment of~     risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or~     safety/tolerability reasons.~   "
180115|NCT01207401|"~     The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine~     administered prior to IUD insertion reduces insertion pain. The hypothesis is that women~     receiving paracervical analgesia will experience less pain during IUD insertion than those~     who do not receive such analgesia.~   "
180116|NCT01207388|"~     The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab~     (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal~     residual disease.~   "
180117|NCT01207375|"~     The current study is a double-blind, placebo-control randomized clinical trial examining the~     efficacy of memory retraining in Traumatic Brain Injury (TBI). Impairment in higher level~     cognitive processing, such as new learning and memory, is one of the most common deficits in~     individuals with TBI and such deficits have been shown to exert significant negative impact~     on multiple aspects of everyday life, including occupational and social functioning. Despite~     these findings, few studies have attempted to treat these cognitive deficits in order to~     improve the everyday functioning of individuals with TBI. The current proposal will evaluate~     (a)the efficacy of this treatment protocol within a TBI population,(b) the impact of the~     treatment on everyday functioning, (c) the long term efficacy of the treatment and (c) the~     utility of booster sessions in facilitating long-term treatment effects. The investigators~     will randomly assign individuals with TBI, with documented impairment in new learning~     abilities, to a memory retraining group or a placebo control group. Both groups will undergo~     baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional~     neuropsychological battery and (2) an assessment of global functioning examining the impact~     of the treatment on daily activities. This design will allow us to evaluate the efficacy of~     this particular memory retraining technique in a TBI population through the assessment of~     cognitive function via a standard evaluation. In addition, the investigators will be able to~     draw conclusions regarding the impact of this particular memory remediation program on~     everyday life from questionnaires completed by the participant and a significant other.~     Optional enrollment in pre/post neuroimaging will also allow us to look at changes in the~     brain.~   "
180119|NCT01207349|"~     Three hundred and ninety height diabetic patients were educated during a week of~     hospitalisation (nutritional and physical-activity advices). After that, they were randomized~     in two groups : frequent follow-up (each three month) by educational nurses and dieteticians,~     versus no follow-up (control group). All patients were evaluated one year after their~     inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors,~     nutritionnal and physical-activity behaviours.~   "
180120|NCT01207336|"~     Recent work showed that application of peripheral nerve and cortical stimulation~     independently can induce 10-15 % improvement in motor performance in patients with chronic~     stroke.~      The purpose of this study was to compare in post-stroke hemiplegic patients the effect on~     motor recovery of one session of anodal transcranial direct current stimulation to the~     ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical~     stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the~     same peripheral nerve stimulation combined with sham tDCS.~      Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for~     the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary~     outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability~     of Ipsilesional M1(TMS) Follow-up: 30 days~   "
180121|NCT01207323|"~     This is a Phase I, multicenter, open-label study of MEHD7945A in participants with incurable,~     locally advanced, or metastatic epithelial malignancies that have progressed despite standard~     therapy or for which no standard therapy exists. The study will be conducted in two stages: a~     dose escalation stage and an expansion stage. The dose-escalation stage is designed to~     evaluate the safety, tolerability, and PK of MEHD7945A administered (at five dose levels from~     1 to 30 milligrams per kilogram [mg/kg]) every 2 week (Q2W). An expansion stage will be~     initiated after establishment of maximum tolerated dose (MTD) in dose escalation stage.~     Participants with refractory or recurrent metastatic colorectal cancer (CRC), non-small cell~     lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and pancreatic cancer~     will be enrolled in an expansion stage to better characterize the safety, tolerability, PK~     and preliminary assessment of the anti-tumor activity of MEHD7945A.~   "
180122|NCT01207310|"~     The proposed study tests the efficacy of using pager-assisted messages combined with nicotine~     patches in facilitating smoking cessation and relapse prevention in a 2-arm randomized~     clinical trial. The hypothesis is that the proportion of biochemically-verified quitters at 3~     and 12 months in the study arm randomized to receive therapeutic messages on alphanumeric~     pagers for 3 months along with individual smoking cessation counseling and nicotine patches~     will be greater that the proportion of biochemically-verified quitters who receive only~     individual smoking cessation counseling and nicotine patches.~   "
180123|NCT01207297|"~     In this comparative open-label cohort study, the investigators compared the efficacy and~     safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse~     proliferative and membranous lupus nephritis with severe renal disease. Treatment of lupus~     nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal~     function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC.~      Methods: Forty patients with diffuse proliferative or membranous were recruited for this~     trial, 45% of them had lower Ccr (<60mL/min/1.73m2), 10% had increased serum creatinine~     (>180µmol/L) and 67.5% had nephritic proteinuria (>3.5g/day). The investigators compared the~     efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC~     group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone~     followed by azathioprine (50mg/day）for 6 months (CYC group).~   "
180124|NCT01207284|"~     The hypothesis is that a physical therapy intervention for foot and ankle of diabetic~     neuropathic individuals would affect positively the way they walk, lowering the harmful~     forces that these segments receive, that are associated mainly with lower range of movement,~     muscle weakness and loss of sensation. The participants will be randomly assigned into~     control group (regular treatment prescribed by their medical group) or into treatment group,~     that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes~     each session. This will aim for increasing foot and ankle range of movement, muscle strength~     and improving sensory inputs.~   "
180125|NCT01207271|"~     The goal of this study is to compare supportive-expressive therapy, a type of psychodynamic~     psychotherapy, with cognitive therapy for the treatment of depression in community mental~     health consumers.~      Hypothesized mediators of treatment will also be examined.~   "
180126|NCT01207258|"~     This study is a randomized controlled trial of a brief intervention for women Emergency~     Department patients with involvement in both Intimate Partner Violence (IPV) and problem~     drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The~     study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief~     motivational intervention, delivered by social workers in the Emergency Department setting,~     in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with~     resources. Social work graduate students and/or staff will be trained to provide brief~     motivational enhancement therapy (MET) intervention for decreasing heavy drinking and~     IPV-related injury in women Emergency Department patients.~   "
180138|NCT01207102|"~     Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane®~     (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and~     tolerability. When combined with a taxane, platinum agents improve response in metastatic~     breast cancer, with carboplatin conferring less toxicity than cisplatin. The investigators~     hypothesize that the combination of weekly Abraxane® and carboplatin will lengthen time to~     progression without producing intolerable toxicity.~   "
180139|NCT01207089|"~     The purpose of the study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of AZD8329 following multiple ascending dose administrations in in~     overweight to obese but otherwise healthy male subjects.~   "
180140|NCT01207076|"~     This study is a single institution phase I study for the treatment of patients with relapsed~     or refractory leukemia aged 12 years and older using 90Y-AHN-12.~   "
180410|NCT01203540|"~     Multicentre, Double blind, Randomized, Comparative Study(comparing N-acetyl-aspartyl-glutamic~     acid(NAAGA) in Abak preservative free device versus SALINE in Abak preservative free device.~      Evaluation of the effects and safety of NAABAK® through inflammation markers and symptoms in~     patients with allergic conjunctivitis and dry eye syndrome after 3 months treatment.~      The patients will attend 4 visits.~   "
180127|NCT01207245|"~     Cystic fibrosis is the most common inherited life limiting condition which affects children.~     Patients with it develop lung infections which become difficult to clear, and damage the~     lungs. These are treated with antibiotics (such as tobramycin) into the vein (termed~     intravenous antibiotics). This has without doubt improved survival. However, all treatments~     have side effects. Tobramycin can cause kidney damage. The investigators have preliminary~     data that suggests that administering tobramycin in the morning may be safer for the kidneys~     than administering it in the evening.~      The investigators plan to approach children and adults with cystic fibrosis whose doctors~     have decided to administer a course of intravenous tobramycin. The investigators will~     randomly allocate them to receive it at either 0800h or 2200h. The investigators will measure~     the rate at which the body eliminates tobramycin from the bloodstream, by measuring the~     amount of tobramycin in the blood stream after administering the antibiotic. For each patient~     the study will last for the duration of the course of antibiotics. This is decided by the~     doctor looking after the patient (rather than the researcher), and would typically be 14~     days. The investigators will also measure substances in the blood and urine (biomarkers)~     which are sensitive indicators of low levels of kidney injury. The investigators will monitor~     lung function and lung bacteria in both the groups to ensure that the patients in both groups~     improve by the same amount.~      If the preliminary data are proved correct, this research will allow investigators to improve~     the safety profile of tobramycin, one of the most widely prescribed drugs in cystic fibrosis.~   "
180128|NCT01207232|"~     The investigators conducted a 3-arm randomized controlled trial to test whether a low-cost~     planning intervention could increase influence vaccination rates.~   "
180129|NCT01207219|"~     The current study aims to evaluate the impacts of yoga and aerobic exercise on~     neuro-cognitive function, symptoms and brain changes in early psychosis. A total of 120~     female subjects who aging from 18-55 years old, and diagnosed with psychotic disorders within~     the past 5 years, will be randomized into 3 groups: 1) yoga therapy, 2) aerobic exercise, and~     3) waitlist group as the control. All groups will try to be kept consistent with their~     medication with no more than 25% change in their entry level dosage for at least six weeks.~     The primary outcomes of the present study will be neuro-cognitive changes; the secondary~     outcomes will be changes of brain structure and function.~   "
180130|NCT01207206|"~     In the current research the investigators would like to examine the effect of a well~     acquainted drug, Ketamine, which is used by anesthesiologists to induce sleep in operations.~     Usually the ketamine is given into the vein and not orally. The investigators want to give it~     orally to cancer patients that sufffer from severe pain to find out whether it can prove~     their quality of life, lower their pain and reduce the amount of opioids they receive.~   "
180131|NCT01207193|"~     There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone,~     but they are most commonly seen in children and young adults while their bones are still~     growing. Living with a bone cyst and determining treatment options depend on the type of~     cyst.~      Non-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals who~     do not experience any symptoms.~      Surgical removal of a unicameral bone cyst is needed if it becomes especially painful, or the~     area of the bone starts to thin out. The investigators aim to assess the clinical efficacy~     and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone cyst.~   "
180132|NCT01207180|"~     The investigators hypothesize that the acquisition and correct utilization of medications as~     well as arranging and attending follow-up appointments will improve as a result of a phone~     call intervention 1-3 days after elderly patients are discharged from the emergency~     department (ED).~   "
180133|NCT01207167|"~     South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high~     rates of cardiovascular disease that is not explained by traditional cardiovascular risk~     factors. Though South Asians represent over one-quarter of the world's population, there are~     no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a~     longitudinal study of South Asians at two United States centers to identify risk factors~     linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of~     this study is to understand the causes of heart disease and stroke in South Asians and~     compare these causes to those in other United States ethnic groups.~   "
180134|NCT01207154|"~     The purpose of this study is to determine whether or not a device which measures depth of~     anaesthesia and sedation can be used to assist in the sedation of patients who must have~     breathing tubes positioned in their airways before general anaesthesia~   "
180135|NCT01207141|"~     This open-label clinical trial will evaluate the pharmacodynamics, pharmacogenomics and early~     efficacy and safety of steroid-free Tacrolimus (TAC) monotherapy and its minimization after~     induction with rabbit, anti-human thymocyte globulin (rATG, Genzyme, Cambridge, MA) in~     children and adults with pediatric liver transplantation. Eighty subjects (0-21 years)~     receiving liver transplantation will be enrolled. Incidence and severity of biopsy-proven~     acute cellular rejection (ACR) is a primary endpoint as well as time to Tacrolimus whole~     blood concentrations <8 ng/ml The expected incidence of ACR is 50% and is derived from a~     non-consecutive subject population (n=40) who received an identical regimen in IND 64555.~     This incidence is acceptable because the long term sequel of rejection reported with other~     allografts have not been observed in liver grafts during IND 64555. These risks are further~     negated by the unique regenerative capacity of the liver allograft. An OBSERVATIONAL arm is~     being included in this trial. Because the numbers of pediatric liver transplants (LTx) are~     small in any single center setting, no information is known about relative outcomes on a~     conventional protocol, in children receiving conventional protocol of steroids+Tacrolimus.~     The PURPOSE of this additional recruitment is OBSERVATIONAL, only. Therefore, these subjects~     will NOT be randomized. Rather, by studying all types of patients, the investigators hope to~     utilize maximally, all available subjects, to understand the relative place of~     monotherapeutic induction. In turn, this will be the basis for a follow-up comparative,~     randomized trial.~   "
180136|NCT01207128|"~     The purpose of this study is to evaluate the therapeutic effectiveness of combination~     antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo~     equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological~     cancer.~   "
180137|NCT01207115|"~     To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to~     placebo in subjects with osteoarthritis (OA) of the knee.~   "
180141|NCT01207063|"~     The investigators group uses an individualised radiation dose approach in which the dose is~     escalated up to pre-defined tissue constraints (see below). The target dose to the tumor is~     69Gy. However, this dose cannot be reached in approximately 30% of the patients, even with an~     IMRT (Intensity Modulated Radiotherapy) technique, because the MLD (Mean Lung Dose)~     constraint of 20Gy is reached at a TTD (Total Treatment Dose) below 69Gy. In this study, the~     investigators will adapt the treatment by performing a new (PET)-CT at day 12 during~     radiotherapy and in case of a decreased Planning Target Volume (PTV), the dose mey be~     increased.~   "
180142|NCT01207050|"~     This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among~     individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both~     objective and subjective measures. It will also show that improvement in sleep/wake patterns~     resulting from Rozerem will impact daytime functioning using objective and subjective~     measures.~   "
180143|NCT01207037|"~     Acute splenic sequestration is a frequent and life threatening complication occurring in~     approximately 10 % of homozygous children. Maximal incidence is between 6 and 18 months.~      The investigators formulate the hypothesis that there are clinical, biological and genetic~     markers predictive of severe complications notably acute splenic sequestration in SCD~     children. The present research project thus aims at analyzing in a forward-looking way the~     profile of severity by analysing clinical, biological and genetic characteristics in a~     multicentric cohort of 60 SCD children~   "
180144|NCT01207024|"~     Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal~     of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious~     sub-chondral bone) before and one year after bariatric surgery.~      Knee MRI is not currently part of the investigations preceding bariatric surgery.~   "
180145|NCT01207011|"~     The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the~     treatment of non-small cell lung cancer (NSCLC).~   "
180146|NCT01206998|"~     The purpose of this study is to compare how well vaginal progesterone works delaying the time~     to delivery in women with preterm labor compared to placebo. The study will also compare the~     effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery,~     cervical length and biomarkers of preterm delivery in women diagnosed with and treated with~     medication to stop preterm labor.~   "
180147|NCT01206985|"~     Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and~     pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous~     and rectal.~      The per-oral mucosal route is not used for the administration of paracetamol. It is a very~     interesting way for the rapid absorption of drugs such as nitrates used in angina pectoris,~     as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows~     very rapid action. In addition, the oral administration-oral mucosa, less restrictive than IV~     administration and faster than oral administration, seek a single medical procedure~     unattended after dosing, will entail no pain or risk for infections the patient (in contrast~     to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of~     paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the~     only dosage form of reference used by the IV route in the protocol Pilot study Pharmacology~     paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by~     half permucosal to assess how changing the pharmacodynamics of the form permucosal to~     125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual~     (under the pillar of the language) and compared with paracetamol in IV.~   "
180148|NCT01206972|"~     The objective of this dose-confirmatory bridging study is to investigate the safety and~     efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous~     thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR)~     and to confirm the extrapolability of global data to Japanese patients by comparing with data~     from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.~   "
180149|NCT01206959|"~     The purpose of this study is to monitor the blood pressure level of the patient using a blood~     pressure monitor which test the blood pressure level in inflating state . The cuff range in~     the study is 22cm-48cm~   "
180150|NCT01206946|"~     The hypothesis of the study is that administration of antenatal steroid to women at high risk~     of preterm birth after 34 weeks of gestation would reduce the risk of respiratory~     complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the~     Newborn (TTN) in late preterm babies.~   "
180151|NCT01206933|"~     Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and~     Molecular Biology of The George Washington University Medical Center are carrying out a~     research study to determine why patients with Human Immunodeficiency Virus (HIV) and~     Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of~     HCV infection, leading to fatty infiltration of the liver and cirrhosis.~   "
180152|NCT01206920|"~     The goal of the DC Cohort is to establish a clinic-based city-wide longitudinal cohort that~     will describe clinical outcomes, and improve the quality of care for outpatients with Human~     Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) in Washington, DC.~   "
180153|NCT01206907|"~     The purpose of this study is to evaluate the effectiveness, tolerability, and safety of~     oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having~     severe to moderate chronic pain.~   "
180179|NCT01206569|"~     Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus~     (SLE). Around one-third of the patients, however, do not respond to conventional~     immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent~     renal failure. Recent studies suggest that immunosuppressive therapy targeted against the~     calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the~     treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm~     study the efficacy and safety of long-acting tacrolimus in the treatment of~     treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis~     will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for~     6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal~     function, clinical and serologic lupus activity will be monitored. This study will explore~     the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor~     prognosis and no effective treatment at the moment.~   "
180154|NCT01206894|"~     Non-Small Cell Lung Cancer (75% of lung cancer) is associated with involvement of the~     parietal pleura and or chest wall (soft tissue and/or bone) in 5-8% of patients. Invasion of~     the chest wall increases the T staging in the Tumor, Node, Mestasis (TNM) classification~     system of lung cancer to a T3 and is associated with decreased survival and more extensive~     operative procedures. The reported 5-year survival for patients with T2 tumors is 58%~     compared to 38% in patients with T3 lesions. The American college of Chest Physician has~     still not identified the best tool to assess chest wall invasion by lung cancer, CT-Scan~     being used by physicians for this assessment. In some studies, CT scan has been shown to have~     a sensitivity ranging from 42 % to 68 % in assessing chest wall invasion, and a specificity~     ranging from 66 % to 100 %.~      Trans-thoracic Ultrasound (US) has the capacity of allowing for dynamic real-time imaging of~     the pulmonary lesion and the chest wall. Therefore, US has the potential to allow for the~     appreciation of subtle findings related to the movement of the lesion and lung over the chest~     wall. Hence, US might be an accurate tool to assess chest wall invasion by lung cancer; thus~     improving pre-operative diagnosis, staging and operative planning of patient with chest wall~     invasion.~      However US is not currently utilized in the pre-operative assessment of patients with lung~     cancer invading the pleura and chest wall, and has not been extensively studied.~      In some rare studies evaluating the accuracy of US, results have shown a sensitivity ranging~     from 89% to 100% and a specificity ranging from 95% to 98% for US detecting chest wall~     invasion by lung cancer. However those studies got criticized. Bandi et al study, got~     criticized by the fact that the operators in the study were experienced interventional~     pulmonologists who perform hundreds of thoracic and endoscopic ultrasound per year. Nobuo et~     al study took place in 1993, since when the device of US has evolved, the investigators can~     not apply with certainty the findings of this study.~      Consequently, there is a need to conduct a study to evaluate the accuracy of US to assess~     chest wall invasion by lung cancer.~      In this prospective study the investigators will assess the accuracy of US, and then compare~     it to the accuracy of the CT-Scan~   "
180155|NCT01206881|"~     The purpose of this study is to determine the efficacy of neoadjuvant treatment with~     pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by~     docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary~     tumor > 5 cm.~   "
180156|NCT01206868|"~     A single centre open randomised parallel-group study to evaluate whether prophylactic~     fenestration of the peritoneum at the time of renal transplantation prevents lymphocele~     formation.~      Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for~     inclusion. From March 2007 to May 2009 130 patients were included. The patients were~     randomized either to peroperative peritoneal fenestration, or to serve as controls.~     Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes~     from each group. Patients who previously had undergone extensive abdominal surgery, or were~     included in other studies were excluded.~   "
180157|NCT01206855|"~     A clinical trial to evaluate the effect of MIST Therapy on outcomes after cosmetic~     procedures(including facelifts, blepharoplasties, breast augmentations and reductions,~     mastopexies, and abdominoplasties) traditionally associated with pain, swelling, bruising,~     and scarring. The study will test the hypothesis that MIST Therapy can decrease the incidence~     and severity of these surgical sequelae throughout the acute and sub-acute phases of healing.~   "
180158|NCT01206842|"~     People with schizophrenia show deficits in social cognition, the ability to process~     information about other people such as identifying their emotional expressions. Social~     cognition is associated with everyday life functioning and could therefore be an important~     treatment target. Several social cognitive training programs have been developed during the~     last years. Results indicate that social cognitive performance can be ameliorated through~     commonly used intervention techniques. However, it is less clear whether this improvement~     generalizes to everyday life. The purpose of this study is to investigate if a social~     cognitive training program (Training in Affect Recognition) improves performance on social~     cognitive and neuropsychological tests and leads to improved everyday life functioning in~     persons with schizophrenia. The study also aims at examining if an improvement is present~     three months after completion of the training intervention.~   "
180159|NCT01206829|"~     A randomized controlled study with hearing impaired workers, who have voluntarily signed up~     for an 8 session cognitive therapy (CBT) course The CBT intervention will be compared to a~     waiting list control group. Participants who are allocated to the intervention group will be~     offered to start on the CBT-course immediately, while the control group that will be offered~     the same course 12 months later. Main outcome measures are assessments of mental distress and~     vocational coping. We will also assess the distress associated with tinnitus, which is a~     potential moderator variable.~   "
180160|NCT01206816|"~     The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD)~     in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992, in patients~     with advanced or metastatic solid tumours. Dosages of both BI 6727 and BIBW 2992 will be~     varied to establish the MTD of the combination. Two combination treatment schedules will be~     tested, the MTD of each combination will be determined.~      Secondary objectives are the exploration of pharmacokinetics, overall safety and preliminary~     efficacy.~   "
180161|NCT01206803|"~     The aim of the study is to explore ovarian response in terms of oocyte numbers after ovarian~     stimulation in a fixed gonadotropin dose GnRH-antagonist protocol by endocrine (AMH, FSH),~     demographic (age), sonographic (antral follicle count) and genetic factors (polymorphisms of~     gonadotropin receptors and secreted gonadotropins).~   "
180162|NCT01206790|"~     Posttraumatic stress disorder (PTSD) is associated with poor health, high health care~     utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune~     diseases. Research, including our own findings, indicates immunological alterations in PTSD~     patients. The aim of this study is to investigate whether alterations in the immune system of~     PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure~     Therapy).~   "
180163|NCT01206777|"~     The purpose of this study is to assess the feasibility of a 60 minute rapid infusion~     rituximab protocol in the institution's outpatient infusion center.~   "
180180|NCT01206556|"~     This study is being done to evaluate how long the immune response from the Human Papilloma~     Virus (HPV) vaccine you / your child received persists. The immune response occurred after~     immunization and is what protects you/your child from HPV disease. You / your child received~     this vaccine as part of an earlier study (P1047). The vaccine is called Human Papillomavirus~     Vaccine (QHPV Vaccine, also known as GARDASIL®). The study will check to see if the~     protective effects (called antibodies) produced by the vaccine have lasted, and for how~     long these effects will continue to last. You will not be given any medications or vaccines~     as part of this follow-up study.~   "
180181|NCT01206543|"~     Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in~     craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.~   "
180411|NCT01203527|"~     The purpose of this study is to determine the pharmacokinetics (PK) of the anti-flu~     medication, Tamiflu during pregnancy and to determine to what extent pregnancy may affect the~     currently recommended dosage of this medication.~   "
180164|NCT01206764|"~     Renal cell carcinoma (RCC) accounts for more than 200,000 new cases of cancer and over~     100,000 cancer deaths annually in the World (Ferlay, et al., 2004). It is estimated that~     there were about 15,000 new cases of RCC in the region that excludes the Americas, European~     Union and Japan. Renal cell carcinomas arise from the proximal tubal epithelium are more~     common in males than in females with an overall lifetime risk of 1 in 75 and a median age of~     diagnosis of 65 years.~      Everolimus (Certican®) has been approved since 2003 in more than 60 countries for the~     prevention of organ rejection in patients with renal and cardiac transplantation. Everolimus~     (RAD001) is a derivative of rapamycin, which acts as a signal transduction inhibitor. It~     targets mTOR, a key protein kinase regulating cell growth, proliferation, and survival. The~     mTOR pathway activity is modulated by the phosphatidylinositol-3-kinase (PI3K)/protein kinase~     B AKT (AKT) pathway, a pathway known to be deregulated in numerous human cancers. RAD001~     (Afinitor®) has been investigated as an anticancer agent based on its potential to act:~        -  directly on the tumor cells by inhibiting tumor cell growth and proliferation;~        -  indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent~          inhibition of tumor cell hypoxia-inducible factor 1 (HIF-1) activity, VEGF production,~          and VEGF-induced proliferation of endothelial cells).~      Primary: To evaluate the PFS rate over time.~      Secondary:~        -  To evaluate the disease control rate (stable disease [SD] + partial response [PR] +~          complete response [CR]);~        -  To evaluate the objective response rate (ORR; where ORR = CR + PR) and duration;~        -  To describe the safety profile of RAD001.~   "
180165|NCT01206751|"~     Multi-detector computer tomography protocol project: Chest imaging technique and case~     presentation.~   "
180166|NCT01206738|"~     1. Do paper-based and web-based intervention modelling experiments (the methodology we are~          developing) identify the same predictors of GP behaviour regarding prescribing of~          antibiotics for upper respiratory tract infections?~        2. Can a web-based IME system provide trialists with richer and more predictive information~          upon which to base the development of behavioural change interventions than paper-based~          IME systems?~   "
180167|NCT01206725|"~     The aim of the study is to compare the effects of aerobic interval training and the IDF~     recommendations on physical activity on cardiac function and CV risk factors in patients with~     diabetes. The hypothesis is that AIT more than MCT, will improve myocardial dysfunction in~     patients with subclinical LV disease, improve both endothelial function and VO2max and thus~     reducing CV risk factors and CV disease. HbA1c will be more stable.~      The aims of this study are to address the exercise prescription recommendations for patients~     with (T2DM) who have subclinical heart disease. The prescription recommendations will be~     assessed by randomising T2DM patients with subclinical heart disease to one of the following~     2 groups for 3 months followed by a 9 month home-based program:~      Moderate Intensity Exercise Group (ME). Home exercise equivalent to the present exercise~     recommendations of the International Diabetes Federation.~      Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved~     through high-intensity interval training.~   "
180168|NCT01206712|"~     The purpose of this phase IV clinical trial is to investigate the effect of Insulin glargine~     + metformin treatment vs. sulfonylurea + metformin treatment vs. DPP-4 + metformin treatment~     vs. healthy volunteers on ß-cell function after the uptake of a standardized meal.~   "
180169|NCT01206699|"~     The specific aim of this study is to determine whether, when treated with corticoid~     infiltration, certain chronic lumbagos could be explained by the presence of a~     neo-articulation.The primary criteria is to determine the difference between the mean pain~     during the latest 24 hours preceding the infiltration and the mean pain preceding the visit~     S4 (visit 4 weeks after the infiltration)~   "
180170|NCT01206686|"~     The goal of this project is to see if encouraging an individual to privately choose in~     advance a narrow time window in which to obtain a flu vaccination shot affects the likelihood~     that he or she will become vaccinated.~   "
180171|NCT01206673|"~     The aim of this study is to evaluate macrophaging activity and immunologic profile of~     patients with Gaucher 's disease. For this, one blood sampling will be performed.~   "
180172|NCT01206660|"~     The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is~     effective for the treatment of patients with moderate to severe plaque psoriasis.~   "
180173|NCT01206647|"~     The purpose of this study is to investigate the success rate of a switch from insulin therapy~     to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus.~   "
180174|NCT01206634|"~     The objective is to assess the effectiveness of regenerative injection therapy (RIT) to~     relieve pain and restore function in patients with knee osteoarthritis.~      The study design is a randomized controlled trial with cross-over. 40 patients with chronic~     knee osteoarthritis will be randomly assigned to receive exercise therapy for 32 weeks in~     combination with RIT on weeks 0, 4, 8, and 12 or exercise therapy for 32 weeks combined to~     RIT on weeks 20, 24, 28 and 32. The primary outcome is the WOMAC score.~   "
180175|NCT01206621|"~     For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF~     causes is essential for proper management. The capacity to triage patients quickly and~     accurately has a beneficial impact upon outcome, disposition, stratification and length of~     stay in the ED and required length of hospital admission.~      The ability to assess pulmonary status rapidly by quantitative regional vibration technology~     offers significant potential advantage for earlier diagnosis. The VRI technique may provide a~     quick and accurate method of differentiating between dyspnea due to HF and dyspnea due to~     pulmonary causes; thereby improving management and outcomes.~   "
180176|NCT01206608|"~     The primary objective of this study was to demonstrate the superiority of SKY0402 over~     conventional, commercially-available bupivacaine HCl with respect to the duration of the~     analgesic effect achieved by a single local administration of the study drug.~   "
180177|NCT01206595|"~     The primary objective of this study was to determine the appropriate dose of SKY0402~     administered as a nerve block for the management of postoperative pain following~     bunionectomy.~   "
180178|NCT01206582|"~     This study is designed to learn if hemin can increase the production of heme oxygenase 1 and~     improve gastric (stomach) emptying and symptoms in diabetic patients with slow gastric~     emptying (gastroparesis).~   "
180193|NCT01206387|"~     efficacy study in patients with moderate to severe plaque psoriasis.~   "
180182|NCT01206530|"~     In this Phase I/II clinical trial, the investigators seek to pilot the addition of~     hydroxychloroquine (HCQ) to the standard front-line therapy of colorectal cancer,~     FOLFOX/bevacizumab. In toxicity terms, the investigators previous studies lead them to~     believe that a full dose (800mg) of HCQ will be well-tolerated in this setting. By starting~     at 600 mg, the investigators will ensure that the full dose is approached with an eye to~     safety, and if needed, the investigators will use the lower dose. Both doses achieve~     autophagy inhibition in our current studies.~   "
180183|NCT01206517|"~     This study is an open label, sequential-group, two site, multiple dose escalating study of~     sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I~     disorder; in one study cohort (3a) participants with other conditions treatable with chronic~     antipsychotic medication can also be enrolled. Participants will receive a single sublingual~     placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily~     (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a~     final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12~     (Cohort 3a).~   "
180184|NCT01206504|"~     This study will test an experimental drug called MGAWN1 for the treatment of West Nile~     infections.~   "
180185|NCT01206491|"~     Department of Chronic Disease and Health Promotion of World Health Organization listed eight~     classes of chronic disease which will be important globally in the future. And the sixth~     class is Chronic Rheumatic Condition, which includes rheumatic arthritis, osteoarthritis,~     osteoporosis, spinal disorders and severe limb trauma. Obviously the osteoporosis is a~     globally important health topic.~      Osteoporosis draws more and more attention, because osteoporosis has various influences, for~     example, (1) psychologically impact which occurs frequently in many chronic diseases, such as~     depression will appear evidently in patients with osteoporosis (2) patients with osteoporosis~     often lose their social role (3) osteoporosis might induce pain and limitation of body~     function (4) osteoporosis increases greatly the possibility of fracture. Osteoporosis will~     induce adverse outcomes, such as the fall of life quality, the increase of morbidity and~     mortality, as well as the increased abuse of medical service. In this project, the~     investigators will set up the intervention model for prevention of osteoporosis as well as~     falls.~      In this project, the investigators will recruit patients form outpatient services at WanFang~     Hospital. Through the collection of baseline data from questionnaire and bone density~     measurement, the investigators can clarify the risk of osteoporosis and falls in studied~     patients. By using double-blind randomized design, the patients will be collected to either~     one of intervention and control group. After eight weeks of intervention programs, the~     investigators will follow on both groups to understand the effect of this program and to~     increase the bone density of intervention group. The hospital or the Health center might take~     the outcome to be the reference of taking care the Osteoporosis.~   "
180186|NCT01206478|"~     Gastrojejunal (G-J) feeding tubes are placed in infants and children who refuse to eat or are~     unable to eat enough to have normal growth. Although often intended as temporary short-term~     solutions to medical complications, feeding tubes can become a permanent method for eating.~      While tube feeding routinely saves the lives of children who have long term food refusal,~     continuation of tube feeding can be hard for patients, caregivers, and families. At the~     current time there are few treatments for helping children move from tube to oral feeding.~     Some patients may be treated with the help of inpatient programs such as a combination of~     medical and behavioral techniques to train children to eat orally. These programs typically~     require hospital stays of 2-4 months.~      By doing the current study the investigators hope to learn if the investigational drug~     amitriptyline is helpful in moving children from tube to oral feeding, and to look at whether~     or not the treatment of pain helps with this transition.~   "
180187|NCT01206465|"~     RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving pralatrexate together with fluorouracil may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of pralatrexate when~     given together with fluorouracil in treating patients with recurrent solid tumors~   "
180188|NCT01206452|"~     The primary purpose of this study is to assess the efficacy of oral prednisone in improving~     the outcomes of pulmonary vein isolation with radiofrequency ablation.~   "
180189|NCT01206439|"~     The purpose of this study is to determine if Nebivolol has any effect on heart function~     determined by changes in echocardiographic data or exercise tolerance.~   "
180190|NCT01206426|"~     This is observational clinical trial to study adult urothelial cancer patients treated with~     cisplatin‐based neoadjuvant chemotherapy.~      Hypothesis: Identification of genetic and molecular cisplatin susceptibility biomarkers~     will allow identification of urothelial cancer patients most likely to benefit from~     cisplatin‐based neoadjuvant chemotherapy.~   "
180191|NCT01206413|"~     The study investigated the effectiveness of home-based exercise combined with a slight~     caloric restriction on weight change during 12 months in non-obese women. In addition the~     investigators evaluate the effects of baseline insulin resistance on modulation of weight~     change.~      A randomized clinical trial with a factorial design was conducted from 2003 to 2005. Two~     hundred three middle-aged women (Rio de Janeiro/Brazil), 25-45 years, were randomly assigned~     to one of two groups: control (CG) and home-based exercise (HB). The HB group received a~     booklet on aerobic exercise that could be practiced at home (3 times/week - 40 min/session),~     in low-moderate intensity, during 12 months. Both groups received dietary counseling aimed at~     a slight energy restriction of 100-300 calories per day.~      The HB experienced a greater weight loss in the first 6 months (-1.4 vs. -0.8 kg; p=0.04),~     but after 12 months there was no differences between groups (-1.1 vs. -1.0; p=0.20). Of the~     serum biochemical markers, HDL-cholesterol showed major change, with an increase at month 12~     of 18.3 mg/dl in the HB compared to 9.5 in the CG (p<0.01). At baseline the non-IR group~     (n=121) compared to IR (n=64) had similar values of BMI (26.7 vs. 26.3 p=0.21), but~     statistically significant lower values of waist, glucose, insulin and HOMA-IR, as expected.~     When the group non-IR and IR were further stratified by GI diet, there were no differences~     according to diet in both groups. Women classified as IR at baseline had greater weight loss~     after 12 months of follow-up (-1.62 kg vs. -1.08 kg; p=0.01), and HB exercise helped to~     reduce weight only among NIR women (-1.51 vs. -0.68; p=0.04); no differences were observed~     between intervention groups for IR women (-1.54 vs. -1.66; p=0.24). There were no differences~     between IR and NIR groups for lipid profile after adjustment for weight changes. During~     follow-up, changes were more pronounced among those women in the high GI diet. These~     differences were statistically significant for weight and BMI and were greater among the IR~     compared to the non-IR. Changes in HOMA-IR after 3 months of follow-up were different~     comparing non-IR with IR at baseline. The IR had a reduction in the HOMA-IR, whereas in the~     non-IR this value increased (-0.73 vs. +0.37; p=<0.001). Also this reduction was greater~     among high compared to low GI diet (p=0.04).~   "
180192|NCT01206400|"~     To study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with~     type 2 diabetes mellitus.~   "
180194|NCT01206374|"~     Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin,~     hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that~     are thought to be required for development of vitiligo, only 5-10% of relatives develop~     disease. The triggers for disease onset have not yet been identified. The intent of this~     study is to research trends in laboratory data, social and medical history that may be~     contributory to vitiligo onset, location of disease, course of illness and response to~     therapy.~   "
180195|NCT01206361|"~     The hypothesis is that there is no difference in persistency between Xalacom and the~     alternative fixed dose combination products (Duotrav and Ganfort) over a 12 month period.~   "
180196|NCT01206348|"~     To determine if a combination of three currently approved acne products are safe and~     effective for the treatment of moderate to severe acne~   "
180197|NCT01206335|"~     The purpose of this study is to determine whether patients with advanced cancers who receive~     OHR/AVR118 solution for injection into the skin can achieve improvement in quality of life.~     Based on a previous study in patients with AIDS, possible benefits may include improved~     appetite and strength; weight gain, improved mood; and decreased fatigue.~   "
180198|NCT01206322|"~     Our goal is to determine the acute effects of intranasal insulin on regional perfusion and~     cognition of older adults. We propose a pilot study to examine the effect of a single dose of~     intranasal insulin on regional vasoreactivity and cognitive functions in 30 subjects with~     T2DM and 30 healthy controls >50 years old using a double blinded, placebo-controlled,~     cross-over design.~      Hypothesis 1: Intranasal insulin improves acutely regional perfusion and vasoreactivity in~     older patients with T2DM as compared with placebo and compared with the control group.~      Hypothesis 2: Intranasal insulin improves cognitive functioning including attention, memory~     and executive function in diabetic patients as compared with placebo and compared with~     control group.~   "
180199|NCT01206309|"~     The purpose of this research study is to better understand the onset and course of graft~     versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.~   "
180200|NCT01206296|"~     This is a phase II study evaluating the use of intraperitoneal gemcitabine given~     intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer.~      The primary objective of this study is to evaluate the overall safety of intraperitoneal~     gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable~     pancreatic adenocarcinoma.~      The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected~     in overall survival at 2-years, to study the patterns of disease recurrence following this~     treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in~     peritoneal cytology with pancreatic cancer resection.~   "
180201|NCT01206283|"~     Secondary brain ischaemia (SBI) usually develops after aneurysmal subarachnoid haemorrhage~     (SAH) and severe traumatic brain injury (TBI). The current management strategies are based on~     intracranial pressure-targeted therapy (ICP-targeted) with cerebral microdialysis monitoring~     (modified Lund concept) or cerebral perfusion pressure-targeted therapy (CPP-targeted). We~     present a randomised controlled study to compare the two management strategies.~      The hypotheses of the study were:~        -  SBI developed after aneurysmal SAH and severe TBI share the same crucial characteristics~          and any treatment applied will essentially treat the same underlying pathophysiology.~        -  ICP-targeted therapy with cerebral microdialysis monitoring according to the modified~          Lund concept is superior to CPP-targeted therapy in managing comatose patients with SBI~          after aneurysmal SAH and severe TBI.~      Sixty comatose operated patients with SBI following aneurysmal SAH and severe TBI were~     randomized into ICP-targeted therapy with cerebral microdialysis monitoring and CPP-targeted~     therapy groups. Mortality rates in both groups were calculated and biochemical signs of~     cerebral ischaemia were analysed using cerebral microdialysis. Outcome for cerebral~     microdialysis was measured as poor outcome (Glasgow Outcome Scale score 1, 2 and 3) or good~     outcome (Glasgow Outcome Scale score 4 and 5).~   "
180202|NCT01206270|"~     Patients with infertility often presents alterations at ultrasonographic examination of the~     testis. These alterations include a much higher incidence of small, multiple, non-palpable~     hypoechoic micro-nodules that can show internal vascularization. This finding often create~     alarm and anxiety, because it has to be placed in a differential diagnosis versus low-stage~     malignant germ cell tumors. Nevertheless, explorative surgery reveal that a consistent number~     of these lesion are benign, due to Leydig cell hyperplasia or Leydig cell tumours. The~     purpose of this study is to evaluate the effects of androgen therapy on the size and number~     of non-palpable hypoechoic micro-nodules in patients with elevated gonadotropin levels.~   "
180203|NCT01206257|"~     This study is to collect the information of Ultravist® in the patients indicated for the~     coronary angiography or PCI, like rate of ADR in patients, the dose for different~     indications, image quality to prove Ultravist the good safety and effectivity~   "
180204|NCT01206244|"~     This study is to determine the diurnal variation of tear meniscus and tear osmolarity in~     normal subjects and dry eye patients.~   "
180205|NCT01206231|"~     This study is aimed to collect the following Serbia-specific epidemiology data on~     hypercholesterolemia: patents characteristics, patients' management/treatment and physicians'~     standard practice. In addition, the aim is to determine the proportion of patients on~     lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C treatment~     goals.~   "
180206|NCT01206218|"~     Evaluation of customized treatment according to BRCA1 assessment in patients with advanced~     gastric cancer~   "
180207|NCT01206205|"~     The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with~     bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This~     study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will~     increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after~     High Dose Therapy (HDT) with ASCT.~   "
180208|NCT01206192|"~     The purpose of this study is to extend the extant work on the typology of intimate partner~     violence (IPV) by employing mixed methods to collect quantitative and qualitative data.~   "
180264|NCT01205464|"~     The aim of this randomised, double-blind crossover study was to determine whether Doxycycline~     has an impact on the persistent symptoms post-neuroborreliosis, through alterations in the~     immune response and whether such an effect could influence the clinical outcome.~   "
180209|NCT01206179|"~     Treatment of nonunion, delayed union and malunion fractures of long bones remains~     problematic. The definition of nonunion is a failure of the fracture to heal in six months in~     a patient in whom progressive repair had not been observed radiographically between the third~     and sixth month after the fracture. First of all good surgical techniques are stable~     immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is~     required. Numerous techniques have been developed ranging from invasive interventions~     (including internal fixation with the use of bone graft or bone graft substitutes) to non~     invasive procedures (ultrasound and pulsed electromagnetic fields).~      Recently, autologous cell therapy was presented as an interesting approach. The concept of~     such therapies is based on the effect of stem cells presented in the bone marrow and able to~     be transformed in osteoblast cells. The purpose of this study is to find if mesenchymal stem~     cells can stimulate bone regeneration in nonunion and delayed union fractures to reduce later~     surgeries required to augment the healing process and to accelerate the time to healing.~   "
180210|NCT01206166|"~     The specific aim of the proposed study is to conduct a pilot study involving 160~     critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of~     America, Belgium and France in order to:~      Specific Aims~        -  Confirm that we can achieve a clinically significant difference in calorie and protein~          intake between the two intervention groups.~        -  Estimate recruitment rate i.e. number of eligible and enrolled patients per month per~          site.~        -  Evaluate the safety, tolerance, and logistics around providing supplemental PN in the~          study population in the context of a multicenter trial, e.g.~             -  To ensure adequate glycemic control in both groups.~             -  To ensure that the other metabolic consequences of the feeding strategies are~               minimized.~             -  To establish adequate compliance with study protocols and completion of case report~               forms~      A secondary aim of this pilot study will be:~      • To explore the effect of differential effects of calorie and protein delivery on muscle and~     mass function.~   "
180211|NCT01206153|"~     Antipsychotics such as risperidone could induce amenorrhea in schizophrenic patients. The~     investigators conducted a randomized, placebo-controlled study to test the efficacy of~     metformin for antipsychotic induced amenorrhea in schizophrenia patients.~   "
180212|NCT01206140|"~     This randomized phase II trial is studying how well giving selumetinib together with or~     without temsirolimus works in treating patients with metastatic, recurrent, or locally~     advanced soft tissue sarcoma that cannot be removed by surgery. Selumetinib and temsirolimus~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It~     is not yet known whether giving selumetinib together with temsirolimus is more effective than~     giving selumetinib alone.~   "
180213|NCT01206127|"~     Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by~     donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part~     (lamellar keratoplasty). One type of lamellar keratoplasty is DSAEK (Descemet's Stripping~     Automated Endothelial Keratoplasty), where only the damaged posterior section of the cornea~     is replaced.~      The purpose of this study is to investigate how immediate postoperative positioning of the~     patient affects the dislocation rate of the corneal graft. Since this is a new surgical~     method, little scientific documentation has been published in this area.~   "
180214|NCT01206114|"~     A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1~     vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the~     first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.~   "
180215|NCT01206101|"~     This trial is conducted in Europe and North America. The aim of this trial is to investigate~     if liraglutide treatment can increase the proportion of insulin-independent subjects one year~     after islet cell transplantation who required only one (single-donor) islet cell transplant.~   "
180216|NCT01206088|"~     The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with~     Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete~     cytogenetic response rate(CCyR) at 12 months after nilotinib administration.~   "
180217|NCT01206075|"~     Thalassemia is considered the most common genetic disorder worldwide, occurring with high~     frequency in Mediterranean areas, the Middle East, Southeast Asia, and the Pacific Islands.~     Currently, the only cure for thalassemia is bone marrow transplantation from a related,~     compatible donor. Gene transfer, achieved by transplantation of the patient's own blood stem~     cells that have been genetically-modified with the corrected gene, could potentially cure~     thalassemia.~      The first step in developing gene transfer for treatment of thalassemia is to develop a safe~     and effective method to obtain blood stem cells from thalassemia patients. Eventually, high~     numbers of genetically modified cells will need to be infused into the patient for clinical~     gene transfer to be effective. The blood stem cells are obtained by giving a mobilization~     agent to the patients. This causes the stem cells to leave the bone marrow and go into the~     blood. The purpose of this study is to test the safety and effectiveness of the new~     mobilization agent, Mozobil, in causing mobilization of blood stem cells for patients with~     beta-thalassemia major.~   "
180218|NCT01206062|"~     Elevated blood pressure (BP) is an important public health concern. It is highly prevalent,~     the prevalence may be increasing, and it is a risk factor for several adverse health~     outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease,~     and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT) is~     a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program~     aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended~     will reduce cardiovascular disease (CVD) risk.~   "
180219|NCT01206049|"~     The purpose of this study is to determine the rate of progression free survival of patients~     with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are~     treated with combination chemotherapy supplemented by biological agents panitumumab or~     bevacizumab.~   "
180220|NCT01206036|"~     In this Phase I study safety of the combination of Docetaxel and Temsirolimus needs to be~     shown before the study can be expanded into a Phase II study to examine the activity of a~     safe combination of Temsirolimus and Docetaxel in a comparison with Docetaxel alone.~   "
180294|NCT01205061|"~     The purpose of the study is to compare the effectiveness and safety of Emervel Deep Lidocaine~     versus Juvederm® Ultra Plus in the treatment of moderate to severe facial wrinkles and folds.~   "
180221|NCT01206023|"~     Multiple Sclerosis (MS) is a complex multi-factorial disease, with underlying both genetic~     and environmental factors. Different populations have different susceptibility. The disease~     is characterized by 2 main phenotypes: relapsing-remitting or progressive course. Clinical~     disability is due to distraction of the CNS myelin.~      Repair processes are mainly noted after the acute attack - and recovery of function can be~     spontaneous. However, in severe attacks sometimes there is need for adding STEROID TREATMENT~     (6 days IV) for the acute attack.~      For the long term prophylactics - following the increased understanding of the disease, in~     the last 10-15 years there are new immunotherapies available (COPAXON / TEVA; Interferon~     -beta). However these can attenuate the disease (reduce the number of relapses per year) but~     are not cure. Also, they are beneficial in only ~40 % of the Relapsing -Remitting patients.~      Currently there are no biomarkers available for MS (other than oligoclonal IgG in the CSF -~     which help confirm diagnosis but require invasive procedure and are not correlated with~     disease activity nor response to therapy) and - monitoring of MS and its treatment is by MRI~     - which is expensive.~      Dr Hossam Haick from the Technion developed an electronic nose based nanomaterials for~     diagnosis of diseases (e.g., cancer, kidney failure, etc.) via breath samples.The research~     hypothesis is that Biomarkers of CNS inflammation and/or neurodegeneration and/or CNS repair~     can be detected by electronic nose.~   "
180222|NCT01206010|"~     Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors. It~     is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of~     cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions~     (primarily nausea) in sensitive clients. The downside of this cautious approach is that a~     substantial proportion of clients may be under-dosed. A blanket dose increase would~     inevitably increase the incidence of side effects, but it is likely that tailoring~     varenicline dosing to clients' needs would be safe and may further increase varenicline's~     efficacy.~      This study will recruit 200 smokers who report little change to their enjoyment of cigarettes~     and no nausea, during the first week of varenicline use. These smokers will be randomised to~     receive the standard dose plus placebo or plus individualised varenicline dose up to 5mg,~     titrated over the next week prior to their target quit day. Urges to smoke, and other~     withdrawal symptoms, experienced during the study period will be compared between groups to~     see if the tailored therapy may be useful.~   "
180223|NCT01205997|"~     Magnesium has been suggested that NMDA (N-methyl D-aspartate)receptor antagonists induce~     preemptive analgesia when administrated before tissue injury , thus decreasing the subsequent~     sensation of pain.~      Following Ethics Committee approval and informed patients consent, Ninety patients 20-60 yr~     old ASA physical status I or II, scheduled for femur surgery under spinal anesthesia, were~     studied in a prospective, double-blinded, randomized way. The patients were randomly~     allocated to one of three groups of 30 each. The magnesium group (groupM) received~     bupivacaine 15mg combined with 0.5ml magnesium 10%,the fentanyl group (group F) received~     bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and the placebo group (group P)~     received bupivacaine 15mg combined with 0.5ml distilled water intrathecally . Time to first~     requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset~     of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension,~     ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90],~     postoperative analgesic requirements and Adverse events, such as sedation, dizziness ,~     Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed~     preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum~     imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a~     supplement analgesic, methadon5 mg intravenously , was to be given for post-operative pain~     relief as needed .~   "
180224|NCT01205984|"~     The place of systemic corticosteroids in the treatment of children with chronic~     rhinosinusitis (CRS) remains unclear. We aimed to assess the effectiveness and tolerability~     of oral methylprednisolone (MP) as an anti-inflammatory adjunct in the treatment of CRS in~     children.Forty-eight children (age 6-17 years) with clinically and radiologically proven CRS~     were included. Patients were randomly assigned to either oral amoxicillin/clavulanate (AMX/C)~     and MP or AMX/C and placebo (P) twice daily for 30 days. Oral MP was administered for the~     first 15 days with a tapering schedule. Primary parameters were mean change in symptom and~     sinus computed tomography (CT) scan scores after treatment. Secondary study parameters were~     mean changes in individual symptom scores after treatment, relapse rate and tolerability.~     Forty-five patients completed the study, 22 received AMX/C and MP, and 23 AMX/C and P. Both~     groups demonstrated significant improvements in symptom and sinus CT scores, comparing~     baseline to end of the treatment (p<0.001). Methylprednisolone as an adjunct was~     significantly more effective than placebo in reducing CT scores (p=0.004), total~     rhinosinusitis symptoms (p=0.001) and individual symptoms of nasal obstruction (p=0.001),~     postnasal discharge (p=0.007), and cough (p=0.009). At the end of the treatment, 48% of the~     children in the P group still had abnormal findings in CT versus 14% in the MP group (p =~     0.013). Therapy-related adverse events were not different between groups. Although~     insignificant, the incidence of clinical relapses was also less in the MP group (25%)~     compared to P group (43%) (p = 0.137). Oral MP is well tolerated and provides added benefit~     to treatment with antibiotics for children with CRS.~   "
180225|NCT01205971|"~     Dental caries is the most common chronic disease of childhood and is increasing in prevalence~     in children 2-5 years old. Racial and ethnic minority groups as well as economically~     disadvantaged individuals are affected the most by this health outcome. This study will test~     if a community-based multimodal intervention will reduce 2-year incidence of early childhood~     caries (ECC) in children aged 0-5 living in public housing developments. The intervention~     combines the components of motivational interviewing (counseling) delivered by dental health~     advocates, fluoride varnish application, oral health assessment and referral. The~     investigators hypothesize that the multimodal intervention with motivational interviewing~     will reduce ECC behavioral risk factors thereby leading to a reduction of ECC incidence when~     compared to fluoride varnish application, written oral health education materials and oral~     health assessment and referral.~   "
180226|NCT01205958|"~     The purpose of this study is to assess the effect of East-West collaborative medicine on~     chronic cervical pain.~   "
180295|NCT01205048|"~     The purpose of this study is to compare the effectiveness and safety of Emervel Classic~     Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and~     folds.~   "
180227|NCT01205945|"~     Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal diameter~     of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third~     eventually rupture if left untreated.~      Several randomized trials showed that ultrasonographic screening for AAA could reduce the~     frequency of acute operations and AAA-related mortality.~      However, all of randomized trials were performed in Western countries. There was no~     randomized trials for AAA screening in Asian countries.~      This randomized, controlled trial is to analyze the benefits of screening old population for~     AAA in Korea.~   "
180228|NCT01205932|"~     The objective of this dose-confirmatory bridging study is to investigate the safety and~     efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous~     thromboembolism (VTE) in Japanese patients undergoing elective total hip replacement (THR)~     and to confirm the extrapolability of global data to Japanese patients by comparing with data~     from overseas phase II study (ODIXa-OD.HIP - Study 11527).~   "
180229|NCT01205919|"~     The purpose of this study is to determine the efficacy of a cognitive behavioral guided~     self-help training provided via the internet on tinnitus distress in a German sample.~   "
180230|NCT01205906|"~     The aim of this study is to compare the efficacy of an internet-based guided self-help~     training for chronic tinnitus with a well-established outpatient group therapy and a~     discussion forum group.~   "
180231|NCT01205893|"~     The purpose of this study is to determine if the Reducer is safe and effective in treating~     the symptoms of refractory angina in patients that suffer from refractory angina who~     demonstrate reversible ischemia.~   "
180232|NCT01205880|"~     This investigator-blinded study is designed to assess whether the order of application~     affects the efficacy of the combination treatment Clobex® Spray (clobetasol propionate) and~     Vecitcal® (calcitriol) Ointment in plaque psoriasis.~   "
180233|NCT01205867|"~     The purpose of this study is to investigate the safety and tolerability of AZD8848 in~     Butyrylcholinesterase deficient subjects in comparison with sex and age matched control~     subjects.~   "
180234|NCT01205854|"~     The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an~     absence of signs and symptoms of the disease. However, the optimal way of reaching this goal~     is not known.~      Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a~     number of advantages over other advanced imaging techniques such as magnetic resonance~     imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a~     short period of time. However, the additional benefit of using this modality in terms of~     patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US~     leads to better care for RA patients.~      This study will assess if the use of a treatment strategy incorporating information from~     ultrasonography assessment will allow for better outcomes of patients with RA, than a~     strategy based on clinical and laboratory assessments alone.~   "
180235|NCT01205841|"~     Comparison of the reliability of different examination techniques to detect fractures in~     patients with ankle trauma.~   "
180236|NCT01205828|"~     This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in~     abbreviation).~      The purpose of this study is to test the efficacy (effectiveness) of a new combination of~     drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging~     deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888~     inhibits an enzyme called PARP which helps to fix damaged DNA. By inhibiting this enzyme,~     ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will~     hopefully increase the killing of cancer cells, and decrease the tumors in the body.~      ABT-888 is an investigational or experimental anti-cancer agent that has not yet been~     approved by the Food and Drug Administration (FDA) for use in liver cancer.~      This study will help find out what effects (good and bad) the combination of drugs,~     temozolomide and ABT-888, has on liver cancer.~      This research is being done because it is not known if ABT-888 will increase the~     effectiveness of temozolomide in liver cancer.~   "
180237|NCT01205815|"~     The purpose of this research is to identify biological characteristics occurring in the~     initiation and progression of melanoma.~   "
180238|NCT01205802|"~     Middle hepatic vein (MHV) reconstruction with an interposition vessel graft has been settled~     as a standard procedure for living donor liver transplantation (LDLT) using a right lobe~     graft. Increasing demand of vessel graft in the situation of limited resources of allograft~     led the investigators to search for new vessel substitutes. Since the use of thin-walled~     expanded polytetrafluoroethylene (PTFE) graft showed poor long-term patency, a prospective~     study is going to be performed to enhance the clinical usability of expanded PTFE graft. A~     clinical study intends to know how to maintain its luminal flow effectively by using ringed~     PTFE graft. During 12 months of study period, ringed PTFE graft will be used for~     reconstruction of MHV reconstruction. The investigators expect that ringed PTFE graft seems~     to be a more useful alternative than usual PTFE graft when adequate autologous or allogenic~     vessel graft is not available.~   "
180239|NCT01205789|"~     The purpose of the Universal Registry is to assess the proportion and reasons for which~     subjects with angiographically significant ULMCA disease requiring revascularization during~     the time course of this study are not randomized; to compare the baseline characteristics of~     subjects; and to assess the variability in randomization eligibility and treatment patterns.~   "
180240|NCT01205776|"~     To establish the safety and efficacy of the commercially approved XIENCE Family Stent System~     (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the~     United States [OUS] only]) in subjects with unprotected left main coronary artery disease by~     comparing to coronary artery bypass graft surgery.~   "
180241|NCT01205763|"~     In this study, the investigators intend to demonstrate that the hook plate may have adverse~     effects on subacromial structures even with a short period of hardware retention. The~     investigators also sought to determine if musculoskeletal sonography could be used as a tool~     to demonstrate shoulder pathology such as subacromial impingement or rotator cuff tear in~     patients receiving hook plate fixation. The clinical results of patients receiving hook plate~     fixation, specifically bony union, pain relief, shoulder function and range of motion (ROM),~     were also evaluated.~   "
181872|NCT01184274|"~     This research is being done because SB939 has been shown to shrink tumours in animals and in~     some people and seems promising, but we are not sure if it can offer better results than~     standard treatment.~   "
180242|NCT01205750|"~     Obesity is associated with dyslipidemia, which is a major risk factor for coronary heart~     disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins,~     and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that~     increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central~     pathophysiological feature of the lipid and lipoprotein abnormalities in dyslipidemia.~      The primary objective of this study is to investigate VLDL-TG kinetics and hepatic insulin~     sensitivity in age-matched obese and lean, healthy men in the postabsorptive state and during~     acute hyperinsulinemia using VLDL-TG and glucose tracers.~   "
180243|NCT01205737|"~     This is a prospective international, multi-center, randomized, double-blind controlled study~     designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of~     MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse~     large B cell lymphoma.~   "
180244|NCT01205724|"~     This trial is conducted globally. The aim of this clinical trial is to investigate the safety~     and pharmacokinetics (the determination of the concentration of the administered medication~     in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe~     haemophilia A.~   "
180245|NCT01205711|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and~     leucovorin calcium, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Zibotentan may be effective in treating~     metastatic colorectal cancer that has not responded to oxaliplatin. It is not yet known~     whether combination chemotherapy is more effective when given with or without zibotentan in~     treating metastatic colorectal cancer.~      PURPOSE: This randomized phase II trial is studying giving irinotecan hydrochloride together~     with fluorouracil and leucovorin calcium to see how well it works when given with or without~     zibotentan in treating patients with metastatic colorectal cancer.~   "
180246|NCT01205698|"~     This clinical trial will determine the effect of varying types of carbohydrates contained in~     milk-based beverages on the glycemic response and GI values.~   "
180247|NCT01205685|"~     Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in human~     beings show that this drug can make a difference in the way anti-estrogens work in~     hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that~     helps them live and grow. Studies done in the laboratory show that OSI-906 can make a~     difference in the way anti-estrogens work in hormone-sensitive breast cancers.~   "
180248|NCT01205672|"~     The goal of this research study is to learn if metformin can affect endometrial cancer cells~     in women who do not have diabetes.~      Objectives:~      Primary Objectives:~      1. To determine the molecular effects of metformin and associated physiologic changes in~     insulin/glucose metabolism on the mTOR (mammalian target of rapamycin) signaling pathway in~     the endometrium of women with endometrial cancer~      Secondary Objectives:~        1. To describe the effects of metformin on the histology and proliferation of the~          endometrium in women with endometrial cancer.~        2. To assess the effect of body mass index on the response to treatment with metformin~        3. To assess the effect of insulin resistance on the response to treatment with metformin~        4. To determine effects of metformin on the serum, urine and DNA biomarkers of women with~          endometrial cancer.~   "
180249|NCT01205659|"~     Allergy and Asthma study of children (3 - 7 Years of age) who participated in randomized~     trials of supplemented infant formula during infancy conducted by The Retina Foundation of~     the Southwest .~   "
180250|NCT01205646|"~     The primary goal for this trial is to assess the change in PET scans with the administration~     of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has~     been established that zoledronate therapy may play a role in delaying and reducing the~     incidence of skeletal events. Researchers propose to evaluate the change in the uptake value~     of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans~     can successfully demonstrate and detect bony metastatic sites in prostate cancer.~      In addition, investigators would like to evaluate the change in the level of the~     prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.~   "
180251|NCT01205633|"~     Patients suspected of CCSVI (chronic cerebrospinal venous insufficiency) may be tested and if~     appropriate treated with catheter venoplasty by an interventional radiologist in their local~     community who has been credentialled either by the local hospital's IRB or a national IRB if~     the procedure is done in an outpatient facility. Catheter angioplasty is a long-established~     and accepted medical procedure, patients' insurance should but may not cover the testing or~     treatment.~   "
180252|NCT01205620|"~     Participants undergoing Off-CABG will be randomized 1:1 to one of the following groups:~        -  treatment with CirQlator TM Intrathoracic Pressure Regulator (ITPR)~        -  no ITPR .Anesthesia will be standardized for both groups. The groups will be compared~          based on the differences in vasopressor use, the number and amount (in milliliters) of~          intravenous fluid boluses required and hemodynamic changes noted, including systemic~          blood pressure, pulmonary arterial pressure, pulse pressure, heart rate (recorded most~          reliably from the arterial line), cardiac output (CO), cardiac index (CI), mixed venous~          oxygen saturation (SVO2), SVR, pulmonary vascular resistance (PVR), and stroke volume~          (SV).~      Specifically, we will compare the groups based on the mean number of intravenous fluid~     boluses, mean amount of norepinephrine and epinephrine infusion required, the number of~     recorded systolic blood pressures < 90 mmHg, and number of CI < 2.0 L/min/m2. We will also~     compare the number of times the surgeon must reposition the heart for treatment of~     hypotension, and ascertain whether the ITPR will help patients tolerate the cardiac~     displacement better, thus decreasing the time required to complete the bypass graft~     anastamosis. ECG will be monitored intraoperatively for signs of ischemia including ST~     changes, greater than 1mm depression or elevation. Postoperatively, we will record the need~     for and amount of diuretic required.~      We hypothesize that in this pilot study, patients undergoing OPCAB who are treated with~     CirQlator TM Intrathoracic Pressure Regulator (ITPR) will achieve higher blood pressures and~     cardiac output and require less intravenous fluids and vasopressor administration than~     patients managed without the ITPR.~   "
180492|NCT01202461|"~     This study is designed to report 3-year result of triple therapy of vitrectomy, intravitreal~     triamcinolone and macular laser photocoagulation for intractable diabetic macular edema.~      Previously author reported 1-year result(Am J Ophthalmol. 2007 Dec;144(6):878-885. Epub 2007~     Oct 15.).~   "
180253|NCT01205607|"~     Patients who have a functioning intracranial pressure-monitoring device (either a~     subarachnoid bolt, or an intraventricular catheter) in place, and are either sedated,~     intubated, and mechanically ventilated (i.e. in the NNICU), or are scheduled to undergo an~     operation or interventional neuroradiological procedure at the University of Virginia.~     Patients with a contraindication to TTE will be excluded.~      For patients in the NNICU, basic hemodynamic variables (systemic blood pressure, central~     venous pressure, etc.) will be collected. In addition, left ventricular performance~     (including estimates of LVEDV, LVESV, EF, FAC, and SV) will be assessed using TTE. Once these~     baseline data are recorded, the ITPR will be inserted in the ventilator circuit and activated~     to provide either -5 mm Hg or -9 mm Hg endotracheal rube pressure (ETP) (based on a~     randomization scheme). After the ITPR has been active for at least five minutes, the same~     intracranial, hemodynamic, and TTE data obtained above will be gathered. The ITPR will then~     be turned off for five minutes, and intracranial, hemodynamic, and TTE data will again be~     recorded. The ITPR will be activated a second time (-9 mm Hg or -5 mm Hg ETP, i.e. whichever~     value was not used previously), and after five minutes of use data will be recorded again.~     The ITPR will then be disconnected, data will be collected after waiting two minutes, and no~     further interventions will be made.~      ABG's will be obtained before and during the use of the device at each setting.~      This is a proof of concept/feasibility study designed to test the primary hypothesis that use~     of the ITPR will result in decreased intracranial pressure and increased cerebral perfusion~     pressure. The effect of the ITPR on secondary indicators of cardiac performance will also be~     examined. These include but are not limited estimates of ventricular end diastolic volume and~     pressure (LVEDV/P), ejection fraction (EF), left ventricular end systolic volume and pressure~     (LVESV/P), fractional area change (FAC), all of which will be assessed by transthoracic~     echocardiography (TTE) or transesophageal echocardiography (TEE).~   "
180254|NCT01205594|"~     Briefly, after the induction of anesthesia and the placement of TEE, hemodynamic variables~     (pulmonary and systemic blood pressure, central and pulmonary venous pressure, cardiac~     output, calculated SVR, etc.) will be collected. In addition, left ventricular performance~     (including estimates of LVEDV, LVESV, EF, FAC, etc.) will be assessed using TEE. Once these~     baseline data are recorded, the ITPR will be inserted in the anesthesia circuit and activated~     to provide -9 mmHg ETP. After the ITPR has been active for at least two minutes, the same~     hemodynamic and TEE data obtained above will be gathered. After the data is recorded, the~     ITPR will be disconnected and no further interventions will be made. In addition to the~     hemodynamic and echocardiographic data described above, an arterial blood gas will be~     obtained from the pre-existing radial artery catheter during the on- and off- states.~      Finally, the TEE examination will be recorded on videotape or DVD. A second~     echocardiographer, blinded to patient and ITPR status will review each echocardiogram and~     assess left ventricular performance. In addition to the data derived at the time of testing,~     the second echocardiographer will assess, if possible, changes in EF using Simpson's method~     of disks is used to calculate the LV volume.~      This is a proof of concept/feasibility study designed to test the primary hypothesis that use~     of the ITPR will result in increased systemic blood pressure and cardiac output in patients~     undergoing CABG surgery. The effect of the ITPR on other secondary indicators of cardiac~     performance will also be examined. These include but are not limited to left ventricular end~     diastolic volume (LVEDV), ejection fraction (EF), left ventricular end systolic volume~     (LVESV), and fractional area change (FAC) as assessed by echocardiography, pulmonary artery~     pressure, and calculated systemic vascular resistance (SVR).~   "
180255|NCT01205581|"~     This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated~     influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or~     HIV will be vaccinated twice with one of the two vaccines and evaluated for development of~     immune responses.~   "
180256|NCT01205568|"~     The primary objective of this study is to evaluate the safety and efficacy of transcatheter~     Cutting Balloon therapy for branch pulmonary artery stenosis resistant to low pressure~     dilation.~   "
180257|NCT01205555|"~     Intra-uterine insemination (IUI), generally in combination with ovarian stimulation, is one~     of the most commonly used treatments for infertility. Accurate timing of insemination, in~     order to coincide with ovulation, has an important impact on the success rate. Optimal timing~     of insemination is achieved either by monitoring follicular growth through serial ultrasound~     measurements followed by the administration of human chorionic gonadotropin (hCG) or by the~     detection of urinary luteinizing hormone (LH). However in cycles where follicular growth is~     monitored there is a possibility of premature LH rise before the administration of hCG, which~     may affect the outcome of the treatment. The goal of the study is to determine if adding the~     testing of urine LH in conjunction with ultrasound monitoring leads to an increase in~     pregnancy rates in IUI cycles when compared to ultrasound monitoring alone.~   "
180258|NCT01205542|"~     Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder~     pain, but it is uncertain whether training should focus directly on the upper trapezius -~     which is most often tender - or on the lower compartments and serratus anterior.~      We hypothesize that strengthening exercise for the lower and middle trapezius as well as the~     serratus anterior will decrease intensity of neck/shoulder pain among office workers~   "
180259|NCT01205529|"~     The purpose of this study is to look for a similarity in people's genes that may help~     understand which people could benefit from certain drugs for the treatment of atrial~     fibrillation (AF).~   "
180260|NCT01205516|"~     INTRODUCTION: There is an important need for inexpensive drugs that treat neuropathic pain.~     Early research suggests that methadone may be a good, inexpensive drug to treat neuropathic~     pain. Methadone is available in a low cost powder that is easily prepared for different~     routes of administration. This study will look at the effect and safety of methadone compared~     to the regular treatment of morphine for the treatment of chronic neuropathic pain.~      OBJECTIVES: First the investigators want to determine if methadone is effective and safe for~     the treatment of neuropathic pain. Since a placebo control group would be unethical, the~     proposed comparator will consist of the gold standard conventional treatment, controlled~     release morphine. The investigators will compare methadone to controlled-release morphine~     with regard to how it affects the level of pain and extent of side effects. Next the~     investigators want to examine safety as well as to determine whether methadone leads to~     improvements in physical and emotional functioning, and participants' satisfaction with the~     treatment.~      METHODS: A double blind, randomized trial comparing methadone and controlled release morphine~     is proposed. After 1-week, participants will be randomly assigned to either methadone or~     controlled release morphine and will gradually build to a dose at which they receive adequate~     pain relief without unacceptable levels of side effects. This 5-week phase will be followed~     by a 6-week dose phase and then a 4-week tapering off phase.~      Study drug: The study drug is methadone supplied in 2.5 mg tablets. The comparator will~     consist of controlled release morphine in 10 mg tablets. The dose of each will range from~     1-12 tablets taken every 12 hours (dose ranges methadone 5-60 mg/day, controlled release~     morphine 20-240 mg/day).~      Setting: This is a 3-site study involving pain clinics in Halifax, Nova Scotia; London,~     Ontario; and Calgary, Alberta.~   "
180261|NCT01205503|"~     The purpose of this study is to determine whether the drug mesna is able to block a series of~     chemical changes that occur in the blood of patients who receive the chemotherapy medicine~     doxorubicin. The researchers believe these blood chemical changes may the cause of cloudy~     thinking or chemobrain that are reported by some patients receiving chemotherapy.~   "
180262|NCT01205490|"~     The investigators are performing a study to determine whether changes in blood flow occur in~     the neck and back of the brain following a series of head positions and a manipulation of the~     upper neck. Each participant will be asked to undergo a series of MRI's to evaluate whether~     there are any changes in blood flow resulting from any of the head positions or manipulation.~     The study will be conducted over a period of 1 day and each participant can anticipate the~     testing to take approximately 120 minutes.~   "
180263|NCT01205477|"~     To investigate the safety and efficacy of methylprednisolone infiltration in anserine~     bursitis treatment~   "
180493|NCT01202448|"~     This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis~     in patients with diffuse large B-cell lymphoma.~   "
180265|NCT01205451|"~     This trial is a multicenter, open-label study to evaluate the safety and efficacy of~     GSK1358820 for treatment in post-stroke subjects with focal wrist, finger and in some cases,~     thumb spasticity. Qualified patients who complete GSK double-blind study 112958 will be~     enrolled. Subjects will receive a single treatment session of intramuscular GSK1358820 200U~     or 240U (if thumb spasticity is present). The subjects will be observed until 12 weeks post~     injection. Outcome measures include changes from baseline at every post injection visit as~     measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global~     Assessment Scale. Safety parameters will be measured including adverse events, vital signs~     (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and~     urinanalysis).~   "
180266|NCT01205438|"~     The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two~     different doses of LY2127399 administered in addition to standard of care therapy in patients~     with active SLE.~   "
180267|NCT01205425|"~     The purpose of the study is to determine whether results of the computed tomography coronary~     angiography may be helpful in planning and performing percutaneous angioplasty in patients~     with stable angina pectoris.~   "
180268|NCT01205412|"~     The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV~     type distribution among women ≥ 20 years of age attending routine cervical screening and~     among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.~   "
180269|NCT01205399|"~     This study will enroll subjects who underwent a ventral hernia repair using the AlloMax~     Surgical Graft at least 9 months in the past.~      All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least~     9 months in the past will be contacted and asked to take part in this clinical study. The~     consented subjects' medical records will be reviewed for evidence of any risk factors of~     hernia recurrence, procedure time, complications and any documented recurrences. The subjects~     will be asked to undergo a physical exam to rule out any recurrences that were not documented~     in the medical records.~   "
180270|NCT01205386|"~     The purpose of this study is to determine if the CROSSER CTO Recanalization System can~     facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the~     Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100%~     narrowing of the artery, with no angiographically detectable antegrade blood flow, and the~     assessment that the lesion has been in existence for a minimum of 30 days. This study will~     enroll up to 100 patients at up to 8 clinical sites. The CROSSER CTO Recanalization System~     was cleared for commercialization by the US Food & Drug Administration. This study also~     involves an imaging device called the IVUS (Intravascular Ultrasound Imaging) catheter. This~     device has been cleared for commercialization by the US Food and Drug Administration and will~     be studied for its cleared intended use. The IVUS catheter is used to generate real-time~     images of the artery, which will allow for evaluation of the artery after the occlusion is~     crossed. This is a post-market registry.~   "
180271|NCT01205373|"~     The main objectives of the present study are to investigate the basic pharmacokinetics of BI~     671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion~     pathways and metabolism following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy~     male volunteers. Secondary objectives are to evaluate the safety and tolerability following a~     single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers.~   "
180272|NCT01205360|"~     The purpose of this study is to determine how manipulation of the programmed intermittent~     time interval and volume influences total drug use, quality of analgesia, and patient~     satisfaction during maintenance of labor analgesia.~   "
180273|NCT01205347|"~     Stress hyperglycemia during myocardial infarction (MI) is related to mortality at short and~     long term. Recent studies, however, revealed that chronic statin treatment may decrease both~     insulin sensitivity and secretion immediately after statin therapy initiation. This study aim~     was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in~     the acute phase of MI.~   "
180274|NCT01205334|"~     Patients have a type of brain cancer called glioblastoma multiforme. Because most GBMs come~     back after standard therapy, patients are being asked to volunteer to take part in a research~     study using special immune cells. They may have already thought about being in this study.~      Some patients with GBM show evidence of infection with a virus called Cytomegalovirus before~     the time of their diagnosis. CMV is found in the cancer cells of some patients with GBM,~     suggesting that it may play a role in causing the disease. The cancer cells infected by CMV~     are able to hide from the body's immune system and escape destruction. We want to see if~     special white blood cells, called T cells, that have been trained to recognize and kill~     special parts of CMV infected cells can survive in the blood and affect the tumor.~      We have used this sort of therapy to treat different types of cancer that are positive for~     other viruses and have had variable results. Some patients have had responses others did not.~     It is not possible for us to predict if this treatment will work for GBM.~      The purpose of this study is to find the largest safe dose of CMV-T cells, to learn what the~     side effects are, and to see whether this therapy might help patients with GBM.~   "
180275|NCT01205321|"~     Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)~     images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.~   "
180276|NCT01205308|"~     In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and~     mortality. Although serum cholesterol concentrations are not always elevated in T1D,~     cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is~     enhanced. The aim of this study is to investigate the effects of plant stanol esters on serum~     lipid and lipoprotein lipid concentrations, plant sterol and cholestanol concentrations as~     well as cholesterol metabolism in T1 diabetics on statin use. The study will give new~     information about how addition of plant stanol esters on statin use improve hypolipidemic~     effects in type 1 diabetes.~   "
180296|NCT01205035|"~     Idiopathic Parafoveal Telangiectasia (IPT) [also known as Idiopathic Perifoveal~     Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia~     (MacTel)] is a disorder of unknown etiology. IPT is classified as Group 2A in the Gass~     classification of macular telangiectasias (Reference 1,5) - a bilateral, but not always~     symmetric disorder. It is characterized in its early stages by dilation and loss of~     parafoveal capillaries accompanied by angiographic leakage, right angle venules, central~     and parafoveal intraretinal cysts.~   "
180277|NCT01205295|"~     Background: Previous studies have shown that anxiety and dissatisfaction with patient~     progress are predictors for increased postoperative pain and reduced impact and efficacy of~     pain treatment. However, it remains to be shown whether patient anxiety and concern are~     predictors for the perceived quality of patient progress and the perceived efficacy of~     treatment.~      The aim of this study is to investigate whether there is a correlation between preoperative~     anxiety and concern, and the perceived quality and efficacy of postoperative treatment. The~     hypothesis is that anxious and concerned patients are less satisfied with treatment and have~     a poorer response of their treatment.~      Methods/design: This PhD-project consists of four coherent studies. 1) A methodological study~     evaluating the CMD-SQ (Common Mental Disorder - Screening Questionnaire) questionnaire by a~     test-retest study. 2) The main study, a prospective follow-up study, has the aim of~     investigating the correlation between patient anxiety and concern, their perceived quality of~     patient progress and the perceived efficacy of treatment. This correlation will be detected~     by means of five questionnaires: CMD-SQ, EQ-5D, SF-12, HVOK, OHS or OSS. 3) A study~     consisting of an explicit internal medical audit with the aim to investigate whether the~     medical assessment of patient efficacy of treatment is consistent with their own~     self-reported efficacy of treatment. 4) An intervention study designed as a randomized~     clinical trial. The aim is to investigate whether a targeted effort towards patients with a~     high score of CMD-SQ, i.e. patients with anxiety and concern, can increase their~     self-reported efficacies of treatment and their perceived quality of progress. A total of 800~     hip- and shoulder-patients will be included.~      Discussion: If a correlation between patient anxiety and concern, their perceived quality of~     progress and the perceived efficacy of treatment is found, it will be relevant to screen all~     hip- and shoulder-patients for anxiety and concern preoperatively and deal with this before~     their operation. This study will provide a proposition of how these patients can be taken~     care of through cognitive behavioural therapy as a targeted effort towards their anxiety and~     concern.~      Aim and hypothesis: The aim of this study is to investigate whether there is a correlation~     between patient anxiety and concern, and their perceived quality and efficacy of treatment.~     The overall hypothesis is that patients who are anxious and concerned are less satisfied with~     their treatment and have a poorer overall efficacy of their treatment.~   "
180278|NCT01205282|"~     The investigators propose a pilot, single blind, placebo run-in, dose finding study of~     pioglitazone in children with autism with the ultimate goal of identifying appropriate dosing~     and outcome measures for a larger follow-up randomized placebo controlled clinical trial. The~     specific aims of this study are: 1) To examine the safety of pioglitazone in children with~     autism spectrum disorders (ASD) ages 5-12 years; 2) To identify appropriate outcome measures~     to be used in a follow-up multisite randomized control trial of pioglitazone in children with~     ASD; 3) To determine the maximum tolerated dose to be used in the follow-up multisite~     randomized controlled trial; 4) To examine the effect of pioglitazone on markers of~     inflammation (cytokine levels) and oxidative stress (superoxide dismutase, malonyl~     aldehydes); 5) To explore the relationship between different doses and response to treatment.~   "
180279|NCT01205269|"~     The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in~     COPD patients.~   "
180280|NCT01205256|"~     This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A~     total of approximately 15 patients will be required. The purpose is to determine the levels~     of R, S methadone at various time intervals after drug administration. Patients will receive~     methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and~     propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients~     will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be~     utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to~     VAS scores, patient and parental satisfaction with analgesia, and a functional pain~     assessment.~   "
180281|NCT01205243|"~     An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor~     the safety and efficacy of ZIAGEN® administered in Korean patients according to the~     prescribing information.~   "
180282|NCT01205230|"~     The purpose of this study is to determine how dosing with ketoconazole (Nizoral) or~     esomeprazole (Nexium) affects the pharmacokinetics of oral pazopanib. The study will also~     test for safety of pazopanib when administered with ketoconazole or esomeprazole.~   "
180283|NCT01205217|"~     This study will test the safety of a drug called lapatinib and how well it works. Lapatinib~     (also called Tyverb or Tykerb) will be compared with another drug trastuzumab (also called~     Herceptin).~      Trastuzumab is an antibody against the HER2 protein. It binds to part of the HER2 protein to~     stop it working. Clinical trials have found that adding trastuzumab to chemotherapy lowers~     the rate of cancer recurrence and improves survival in women with HER2 positive breast~     cancer.~      Lapatinib also stops the HER2 protein working and may slow or stop cancer cells from growing~     and may prevent cancer from returning. Lapatinib has been approved in some countries to treat~     patients with certain types of breast cancer. However lapatinib has not been approved to~     treat early breast cancer. This study is one of many being carried out involving lapatinib in~     early breast cancer and these studies are showing that it is a promising treatment.~      This study will compare lapatinib and trastuzumab. One group of people will take lapatinib~     and another group will take trastuzumab. The effects of the drugs, both good and bad, will be~     compared. This study will compare two different durations of HER2 treatment to see if earlier~     introduction of HER2 treatment is beneficial. The lapatinib group will receive HER2 treatment~     from the very beginning for 24 weeks prior to surgery and the trastuzumab group will only~     receive HER2 therapy for 12 weeks prior to surgery.~   "
180284|NCT01205204|"~     The purpose of this study is to evaluate the safety, quality and duration of block with the~     addition of Clonidine in different doses to 0.5% heavy bupivacaine, and to compare it with~     addition of Fentanyl to 0.5% heavy bupivacaine in sub- arachnoid block.~   "
180285|NCT01205191|"~     Definitions~      CBT-ubiquitous - Cognitive behavioural therapy (CBT) provided with all-time (ubiquitous)~     support by cell phone applications CBT-TAU - Cognitive behavioural Therapy provided 'As~     Usual' CBT-placebo - Cognitive behavioural therapy provided with access to a digital audio~     player with self-administered materials for stress management and relaxation.~      Study objectives~        1. to compare the relative effectiveness of a computerized ubiquitous CBT (CBT-ubiquitous)~          against anxiety disorders with CBT-treatment as usual (CBT-TAU);~        2. to assess the safety and tolerability of the CBT-ubiquitous as compared with CBT-TAU and~          CBT provided with access to a placebo technical device (CBT-placebo)..~      Study implementation~      The investigators hypothesize that all active treatments are superior to placebo given~     evidence that face-to-face CBT is effective in the treatment of both anxiety and depression.~     The investigators also predict that patients receiving CBT-ubiquitous will show greater~     improvement than those given CBT-TAU, and assume that CBT-ubiquitous leads to improved~     adherence with treatment compared to CBT-TAU and CBT-placebo.~      The investigators will use an intention to treat (ITT) approach to fulfill the study aims, by~     which the investigators mean that clients are analysed as randomized rather than by treatment~     actually received. The study will be implemented in the central district of Östergötland~     County Council (pop 145.000). The research group has in two previous projects (VINNOVA~     2005-2007, VINNOVA 2008-2009) established cooperation with the 'Unga Vuxna' (Young Adults)~     service provided in this district. The service supplies CBT to the subpopulation experiencing~     early stages of mental disorders in the age group 16-25 years (n=20,000) in order to prevent~     development of significant psychiatric disease and disability. The service employs six~     therapists with at least one year specific CBT training and is co-located with Primary~     Healthcare Centres (PHCs) in downtown Linköping, Åtvidaberg and Kisa. Clients staying outside~     the urban areas can make appointments with therapists at their closest PHC on a weekly basis.~   "
180354|NCT01204268|"~     The current study is designed to clarify the neuroprotective effect of sevoflurane~     preconditioning on the patients underwent intracranial aneurysm surgery.~   "
180355|NCT01204255|"~     RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into~     the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial~     studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.~   "
180286|NCT01205178|"~     SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed~     by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and~     Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of~     acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3~     days.~      The current gold standard for radical cure of P. vivax malaria in many areas of the world is~     chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine~     (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class of~     drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase (G6PD)~     deficiency. The current study will identify a dose of TQ within the target efficacious dose~     range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14 days (i.e. ≤~     25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).~   "
180287|NCT01205165|"~     Objective(s) The primary study objective is to assess the antiviral effect of 12 weeks of~     adefovir dipivoxil treatment in Korean patients with chronic hepatitis B and compensated~     liver disease. The secondary study objectives are to assess the antiviral effect, clinical~     benefit and safety of 52 weeks of adefovir dipivoxil treatment.~      Endpoint(s) The primary efficacy endpoint is Mean log10 reduction in serum HBV DNA level~     from baseline to Week 12.~      The secondary efficacy endpoints include (a) the proportion of patients achieving serum ALT~     normalization at Week 52, (b) other assessments of antiviral effects (the proportion of~     patients achieving HBV DNA no less than 300 copies per mL at Week 52), (c)HBeAg loss, HBeAg~     seroconversion, HBsAg loss and HBsAg seroconversion, (d)the proportion of patients achieving~     serum ALT normalization at Week 12.~      Study Design This is an open label, multi centre phase IV study for Korean patients with~     chronic hepatitis B and compensated liver disease, assessing the antiviral effect of 12 weeks~     treatment of Adefovir dipivoxil as a primary objective and antiviral effect, clinical benefit~     and safety of 52 weeks treatment as secondary objectives.~      Patients will be screened for eligibility criteria and the baseline visit for the treatment~     initiation should occur no more than 4 weeks after screening. Total treatment period will be~     52 weeks and patients will return to the clinic for assessments as scheduled during treatment~     period. After the 52 week study period, it is likely that the patient will benefit from~     continued treatment with commercial adefovir. If in the investigator's clinical judgement~     this is the case, the investigator should ensure that a routine prescription is available in~     a timely manner, and that no unnecessary interruption in treatment occurs.~      Study Population A minimum of 100 male or female Korean patients more than 18 years of age~     with HBeAg positive chronic hepatitis B and compensated liver disease who meet the~     eligibility criteria will be enrolled.~      Study Assessments and Procedures~      Potential patients will be screened prior to study entry and eligible patients who have given~     their consent will have further baseline assessments. Following the screening, the first~     doses of study medications will be given at baseline and patients will return to the clinic~     for assessment as scheduled during treatment period. Patients who discontinue treatment~     prematurely will be followed up every 4 weeks for 12 weeks following the withdrawal visit.~     The following key assessment and or measurement will be made at one or more visits during the~     study. (See section 14.1 Appendix 1. Time and event schedule):~        -  Pregnancy test (females of child-bearing potential only)~        -  Haematology and serum chemistry profile including prothrombin time(PT) and AFP~        -  HBV DNA (Roche COBAS AMPLICOR HBV MONITOR Test, LLOD 300 copies per ml)~        -  Hepatitis B markers: HBeAg(Anti HBe will be tested if HBeAg is negative), HBsAg(Anti HBs~          will be tested if HBsAg is negative) Investigational Product(s) Adefovir dipivoxil 10mg~          tablets will be supplied by GlaxoSmithKline and presented as a white to off white, round~          tablets, packaged in the bottle containing 30 tablets~   "
180288|NCT01205152|"~     This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and~     young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042).~      Partial funding for this study was provided by the Office of Orphan Product Development~     (OOPD).~   "
180289|NCT01205139|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 on the steady-state pharmacokinetics of TMC278 or Tenofovir , and vice versa. Steady~     state is a term which means that the drug has been given long enough so that the plasma~     concentrations will remain the same with each subsequent dose. TMC435 is being investigated~     for the treatment of chronic hepatitis C virus (HCV) infection. TMC278 and Tenofovir are two~     antiretroviral drugs for treatment of human deficiency virus (HIV) infection.~     Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the~     body and eliminated from the body.~   "
180290|NCT01205126|"~     The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic~     System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in~     participants with cancer-related pain.~   "
180291|NCT01205100|"~     Background: Abdominal bloating is a frequent and bothersome complaint in patients with~     functional gut disorders without satisfactory treatment to date. Recent data from our~     laboratory indicate that abdominal distention in these patients is produced by~     abdomino-phrenic dyssynergia: diaphragmatic contraction associated with abdominal wall~     relaxation (particularly the internal oblique). In analogy to other clinical situations (e.g.~     functional outlet obstruction, rumination or aerophagia) behavioral treatment by means of~     biofeedback might be equally effective in these patients. The investigators hypothesized that~     abdomino-phrenic coordination and abdominal distention can be controlled by biofeedback~     techniques.~      Aim: to prove the efficacy of behavioural treatment using biofeedback techniques for~     abdominal distension.~      Randomization: Patients will be randomized into biofeedback and placebo groups.~      Intervention. Biofeedback: patients will be taught to control abdominothoracic muscular~     activity by bio-feedback using online electromyography information. Placebo: patients will be~     given a pill containing placebo medication. Interventions will be delivered in 3 sessions (20~     min each) over 10-day period~      . Measurements: Sensation of abdominal distension will be assessed by means of graphic rating~     scales graded from 0 (no perception) to 6 (very intense sensation). The activity of the~     abdomino-thoracic muscles will be recorded. Abdominal distension will be measured by a metric~     tape fixed to a non-stretch belt placed over the umbilicus.~      Outcomes: Primary outcome: Change in sensation of abdominal sensation. Secondary outcomes: a)~     changes in thoraco-abdominal activity of the muscular walls; activity of thoraco-abdominal~     muscles (intercostals, diaphragm, external oblique, internal oblique, upper rectus, lower~     rectus) will be measured by electromyography; b) changes in girth; abdominal girth will be~     measured using a nonstretch belt (48mm wide) that is placed over the umbilicus. The~     overlapping ends of the belt will be adjusted carefully with two elastic bands to adapt~     constantly to the abdominal wall.~   "
180292|NCT01205087|"~     This clinical study is designed to evaluate the safety and immune modulatory effects of oral~     administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the~     metabolic syndrome.~   "
180293|NCT01205074|"~     Several factors will be tested to see if they have an influence on the methacetin breath test~     results. Each one of the factors has been raised as a possible source of distortion of the~     MBT result.~      I. Variability between same tests on same subject MBT. Repeatability will be tested in both~     healthy individuals and patients with chronic liver disease.~      II. COPD - Chronic obstructive pulmonary disease is a leading cause of death worldwide, and~     can potentially have an effect on the MBT since the breath test is based on CO2 production~     and these subjects may have abnormal CO2 production.~      III. Smoking- 13C Methacetin is metabolized by healthy hepatocytes reflecting hepatic~     microsomal function of CYP1A2, and smoking may cause induction of CYP1A2. Furthermore,~     internal preliminary data has shown signs that there is an influence of smoking on the MBT~     ranges.~      IV. Age- Empirical data on several hundred subjects with chronic liver disease has shown that~     age is a significant factor in determining the probability of disease severity and~     preliminary data in normal subjects have shown changes in MBT with age.. Therefore, the~     effect of age has to be elucidated in an orderly fashion.~      V. CYP450 1A2 Inhibitors- Several drugs and food items inhibit CYP450 1A2 and may affect the~     MBT.~      VI. Alcohol - Alcohol ingestion leads to induction of hepatic CYP and at a later stage to~     inhibition due to liver damage. Acute alcohol ingestion may therefore effect MBT results.~      VII. Beta-blockers - beta blocker are affecting portal hypertension and may affect hepatic~     blood flow and thereby the outcome of the methacetin breath test.~   "
180521|NCT01202084|"~     The primary objective will be to compare the impact of the study formulations on pulmonary~     function in persistent asthma carriers.~   "
180297|NCT01205022|"~     RATIONALE: Radiolabeled monoclonal antibodies can find tumor cells and either kill them or~     carry tumor-killing substances to them without harming normal cells. Giving radioactive~     substances together with antibodies may be effective treatment for some advanced cancers.~     Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and leucovorin~     calcium (FOLFIRI), work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood~     flow to the tumor. Giving radiolabeled monoclonal antibodies together with combination~     chemotherapy and bevacizumab may be an effective treatment for colorectal cancer.~      PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of~     yttrium Y 90 DOTA anti-CEA (Carcinoembryonic antigen) monoclonal antibody M5A when given~     together with combination chemotherapy and bevacizumab in treating patients with metastatic~     colorectal cancer.~   "
180298|NCT01205009|"~     In an era of delayed fertility plans, there is increasing need for fertility treatment in~     older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to~     treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.~   "
180299|NCT01204996|"~     The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when~     administered to patients with solid tumors in combination with 4 standard of care~     chemotherapy regimens.~   "
180300|NCT01204983|"~     Human milk is associated with substantial benefits to infants' health and development,~     especially in premature infants. Some mothers are unable or unwilling to provide breast milk~     to their infant. The use of donor human milk as an alternative to cow milk in these infants~     has risen dramatically in the past year. However, there have been recent reports of~     hyperphosphatemia and hyponatremia associated with the consumption of donor human milk~     products. These electrolyte imbalances can lead to concerning symptoms, including headache,~     nausea, vomiting, altered mental status, coma, seizures, or heart failure. It is important to~     recognize and appropriately treat these electrolyte disturbances associated with donor human~     milk to avoid potential nutritional problems.~   "
180301|NCT01204970|"~     Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive~     pulmonary disease (COPD) and lung transplant recipients is described and will be correlated~     with clinical findings in order to described small airway remodelling in these patients.~   "
180302|NCT01204957|"~     Japanese postmenopausal women in Japan have about one ninth the rate of American~     postmenopausal women. Rates of breast cancer double even after just ten years among Japanese~     women who migrate to the US. Diet is thought to be an important factor, and the investigators~     were interested in whether dietary seaweed, with and without soy supplements, could influence~     known biomarkers of breast cancer risk in American women.~   "
180303|NCT01204944|"~     The Swiss Transplant Cohort Study is an observational prospective cohort study enrolling all~     patients after solid organ and stem cell transplantation since 5/2008 in Switzerland.~     Predefined variables are collected at defined time points. Individual samples (PBMC, plasma,~     DNA) will be stored for future projects. Data relevant to transplantation outcome with~     emphasis on immunological and infectious complications as well as psychosocial variables will~     be gathered.~   "
180304|NCT01204931|"~     Gastroesophageal reflux disease (GERD) is currently defined as a condition which develops~     when the reflux of stomach contents causes troublesome symptoms and/or complications.~     Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In~     recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has~     increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory~     pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group~     pH monitoring has emerged as an important physiologic test to determine the degree of~     esophageal acid exposure and to assess the association between patients' persistent symptoms~     and acid reflux events. The aims of this study are to assess the sensitivity and specificity~     of symptom associated indices and determine the best parameter for predicting GERD from a~     list of conventional pH measurement findings.~   "
180305|NCT01204918|"~     This study aims to examine the antidepressant efficacy of riluzole, employing a randomized,~     double-blind, placebo-controlled, adjunctive trial in treatment-resistant major depressive~     disorder (TRD).~   "
180306|NCT01204905|"~     This is a pilot, open-label study of raltegravir and maraviroc in combination for the~     treatment of antiretroviral naïve patients. The study will enroll 10 antiretroviral naïve~     patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48~     weeks. The combination of these two agents has the potential to be a potent regimen with~     minimal metabolic complications. However, they have not been studied in combination~     previously.~      This pilot study proposes to evaluate this combination in antiretroviral naïve patients to~     document the safety and efficacy of this combination in order to provide clinicians with a~     treatment regimen that minimizes the risk of metabolic complications.~   "
180307|NCT01204892|"~     The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis~     Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of~     trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.~      Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce~     postoperative pain scores when compared to conventional postoperative pain control with local~     infiltration of trochar insertion sites.~   "
180308|NCT01204879|"~     This study will evaluate the efficacy of an exercise-based contingency management (CM)~     intervention. A total of 120 substance abusing patients in intensive outpatient treatment~     will be randomly assigned to one of two conditions: (a) standard care plus CM for completing~     goal-related activities not related to exercising (e.g., improving work, family, or~     transportation issues), or (b) standard care plus CM for completing exercise-related~     activities. Compared to those receiving goal-related CM activity contracting, it is expected~     that those in the exercise CM condition will participate in more physical activities and~     develop greater strength and flexibility, decrease drug use, reduce HIV risk behaviors,~     lessen depressive symptoms, and improve health indices.~   "
180309|NCT01204866|"~     The purpose of this study is to determine if Valortim, or one or more of its selected~     formulation components, induces a wheal reaction when introduced percutaneously.~      Two of 4 subjects dosed in a previous study with a modified formulation of Valortim~     experienced treatment related adverse events which were suggestive of allergic or~     allergic-like reactions. In order to better characterize these reactions and determine if~     they represent allergic or allergic-like reactions to Valortim or one or more of its~     components, skin testing of Valortim and selected components on naïve and Valortim-exposed~     subjects will be performed in this study~   "
180310|NCT01204853|"~     The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were~     demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU,~     Canada and Australia. In this study, the safety and efficacy after administrations of~     sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be~     investigated in Japanese PAH patients.~   "
180311|NCT01204840|"~     The purpose of this study is to determine if growth hormone given 4 weeks before as well as~     during a cycle of in vitro fertilization will improve outcomes in women who have had previous~     failure with IVF treatment cycles using high doses of follicle stimulating medications and~     had a poor response (less than 6 follicles).~   "
180312|NCT01204827|"~     Patients with HBeAg negative chronic HBV and evidence of hepatic disease (elevated liver~     enzymes or evidence of cirrhosis) who have significant viremia are treated with anti HBV~     therapy. Currently the key goals of anti HBV therapy are profound and prolonged viral~     suppression and treatment efficacy is assessed by monitoring viral load and liver enzymes.~     However these do not always reflect the degree of liver impairment or the degree of~     improvement in response to therapy. Sebivo has been accepted in Israel as a first line~     therapy for HBeAg negative and HBeAg positive chronic HBV with evidence of liver damage.~     Viral load should decrease by 1 log every 3 months, otherwise patients should be offered~     add-on or alternative therapy. As the majority of patients in Israel are HBeAg negative~     chronic HBV and in order to have homogenous population we will select for our study only~     patients with HBeAg negative chronic HBV. The 13C Methacetin breath test, assess liver~     function and specifically the function of the microsomal CYP4501A2. It has been shown to~     correlate with the degree of liver impairment and with clinical outcomes in both acute and~     chronic liver disease. The aim of this study is to determine the utility of the 13C~     Methacetin Breath Test to follow up patients with HBeAg negative chronic HBV receiving anti~     viral therapy.~   "
180313|NCT01204814|"~     MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the~     prevalence of ARV resistance in the population of women who present to study sites to be~     pre-screened or screened for participation in an HIV prevention trial. To date, a~     comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive~     age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV~     drug resistance mutations among women who test HIV-positive when presenting to screen for~     participation in HIV prevention trials.~   "
180314|NCT01204801|"~     The purpose of this randomized Phase III study is to determine whether preoperative focused~     microwave heat treatment and chemotherapy combined are more effective than preoperative~     chemotherapy alone in the treatment of large breast cancer tumors in the intact breast.~     Combining heat with chemotherapy before surgery might shrink the tumor so that it can be~     removed in a breast conserving surgery (lumpectomy) instead of a mastectomy.~   "
180315|NCT01204788|"~     Patients with leukemia often have low white blood cell counts after chemotherapy, which puts~     them at greater risk for infection. The standard of care for preventing infections is to give~     these patients antibiotic, antifungal, and antiviral drugs during the time that white blood~     cell counts are low. However, many patients still develop infections during chemotherapy.~     Radiated white blood cell transfusions are a standard treatment once a patient develops a~     severe infection.~      The goal of this clinical research study is to learn if giving unirradiated white blood cell~     transfusions early in chemotherapy might delay or prevent infections in patients with~     leukemia. Researchers also want to learn more about the type and severity of any infections~     that do occur.~   "
180316|NCT01204775|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin~     in pediatric patients with type 2 diabetes.~   "
180317|NCT01204762|"~     At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious~     for the treatment of chronic hepatitis B virus infection (CHB)~      Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary~     data on the safety of pegylated interferon Lambda (Lambda) when administered in combination~     with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic~     hepatitis B(CHB) infection employing a sequential therapy approach~   "
180318|NCT01204749|"~     The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is~     superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or~     resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.~      AMG 386 is a man-made medication that is designed to stop the development of blood vessels in~     cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called~     angiogenesis, to obtain a supply of oxygen and nutrients to grow.~   "
180319|NCT01204736|"~     Active elbow extension has significant functional benefits for individuals with tetraplegia.~     The proposed work will provide information to assess how effectively people are using their~     elbow extension tendon transfers, and whether one surgery works more effectively than the~     other. This study will provide recommendations to clinicians about the possibility of~     improving function after surgery using rehab techniques.~   "
180320|NCT01204723|"~     The primary objective of this application is to test the neurobehavioral mechanisms and~     effects of aprepitant as a new cessation agent for cannabis, tobacco or both.~   "
180321|NCT01204710|"~     This is a study evaluating the safety and efficacy of the monoclonal antibody IMC-3G3 plus~     mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic~     castration-refractory prostate cancer following disease progression or intolerance on~     docetaxel-based chemotherapy.~   "
180522|NCT01202071|"~     The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg,~     20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5~     days to healthy adult male Japanese participants. This was a single-center, open-label,~     randomized, four-treatment, four-way crossover study.~   "
180322|NCT01204697|"~     This randomized parallel group study will assess the efficacy and safety of erlotinib~     [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in~     former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer.~     Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4~     cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally,~     days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is~     until disease progression.~   "
180323|NCT01204684|"~     The main purpose of this study is to evaluate the most effective immunotherapy vaccine~     components in patients with malignant glioma. Teh investigators previous phase I study (IRB~     #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant~     brain tumors, and with an indication of extended survival in several patients. However, the~     previous trial design did not allow us to test which formulation of the vaccine was the most~     effective. This phase II study will attempt to dissect out which components are most~     effective together. Dendritic cells (DC) (cells which present or show cell identifiers to~     the immune system) isolated from the subject's own blood will be treated with tumor-cell~     lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing~     (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the~     immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed~     DCs will then be injected back into the patient intradermally as a vaccine. The investigators~     will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like cell) in some~     treatment cohorts. It is thought that the host immune system might be taught to recognize~     the malignant brain tumor cells as foreign to the body by effectively presenting unique~     tumor antigens to the host immune cells (T-cells) in vivo.~   "
180324|NCT01204671|"~     This study is designed to assess the safety and immunogenicity of a GSK Biologicals'~     investigational vaccine GSK2321138A in adults 18 years old and older. This study is also~     designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be~     double blind for all groups except for the GSK2604409A Group which will be open.~   "
180325|NCT01204658|"~     This study will assess the safety, reactogenicity and immunogenicity of two formulations of~     GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course~     during the first 6 months of life followed by a booster dose at 12-15 months of age and~     co-administered with DTPa-HBV-IPV/Hib vaccine.~   "
180326|NCT01204645|"~     Chronic kidney disease (CKD) affects 10-18% of the adult population and is becoming~     recognized as one of the most serious disorders causing increased risk for cardiovascular~     disease and death. In patients with ischemic heart disease 26% have increased creatinine,~     which rises to 40% if patients also have diabetes mellitus. Risk increases as renal function~     diminishes, and just slowing the rate of decline in renal function would have a tremendous~     impact on health and morbidity. This association is commonly termed the Cardiorenal Syndrome,~     though it is caused by a much more complex interplay between major pathogenetic pathways such~     as glucose metabolism and diabetes, systemic and tissue inflammation, tissue metabolism,~     coagulation, mineral metabolism, sympathetic activation, renin-angiotensin-aldosterone system~     activation, endothelial dysfunction, lipid metabolism, fetal programming etc.~      Karolinska Institutet recently merged basic and clinical researchers in all these fields,~     creating a Karolinska Kardiorenal Theme Centre; ultimately aiming to explore the syndrome and~     provide improved care for the individual patient.~      The investigators road to success:~        -  Creating a Biobank (blood, DNA, plasma) from the majority of all hosptalized patients~          with ACS in Stockholm county - Stockholmheartbank.~        -  This Theme Center include all teaching hospitals associated with Karolinska Institutet;~          Danderyd University Hospital, Karolinska University Hospital and Södersjukhuset~          University Hospital. Together theses hospitals serve as emergency hospitals for 1.9~          million people. The investigators are aiming at creating a biobank from all patients~          admitted for an acute coronary event (about 2.300/yr), which is a unique asset for~          molecular and genetic research as well as observational and intervention studies.~        -  The investigators have access to the National registry with 100% coverage, that contains~          data on all patients admitted to Stockholms coronary care units since 1995.~        -  To ensure translation in to clinical practice, most of the researchers are also MD:s,~          and several are clinically active.~        -  The clinical network facilitates the development of novel therapies and translational~          research.~        -  Steering groups for Education and a Clinical Practice implementation program.~   "
180327|NCT01204632|"~     The purpose of this study is to develop and field-test new tools for diagnosis and hazard~     assessment of cardiometabolic risk (CMR) in people with chronic spinal cord injury (SCI) and~     to advance the evidence base with much needed information on CMR and cardiovascular disease~     (CVD) burden in people with SCI. These data can be used to develop screening guidelines for~     early identification and prevention of CMR in SCI, as well as targeted approaches to primary~     disease management.~   "
180328|NCT01204619|"~     Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis~     for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients~     on PD has continued to decrease each year. There have been a growing concern and research on~     patient and technique survival of peritoneal dialysis versus hemodialysis to find influential~     factors for better clinical outcomes. Meanwhile, technique failure rates were significantly~     higher in small centers treating less than twenty five PD patients. And there was a result~     for better technique survival after the second year, among the patients trained at the~     BREC(Baxter Renal Education Center). Better technique survival in large centers can be~     assumed with not only their more experience with patient management but also their~     educational infrastructure compared to small-sized centers.~      Throughout our experiences in the last 30 years, we have recognized that a major element of~     PD program is patient training, however few data are available in terms of the relationship~     between PD training and treatment outcome and mostly are retrospective and non-randomized.~     Moreover, the technique survival and patient survival were analyzed with no significant~     difference.~      From the insight, we decided to study prospectively to evaluate the efficacy of~     well-structured education program in terms of various patient outcomes in incident patients~     on PD.~   "
180329|NCT01204606|"~     -  The purpose of this study is to compare the efficacy of periarticular injections~          consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with~          the efficacy of periarticular injections consisting of the same amount of~          placebo(isotonic saline) during arthroscopic rotator cuff repair.~        -  Adding of multimodal analgesia(MMA) to conventional rotator cuff repair, it was expected~          that could reduce postoperative pain and narcotic consumption.~   "
180356|NCT01204242|"~     The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given~     during anesthesia intravenously (IV) through a needle in your vein,), can:~        1. Help decrease pain after surgery.~        2. Have you need less pain medication.~        3. Have less side effects like nausea and vomiting following your surgery.~        4. Help to prevent chronic pain.~        5. Affect recurrence of cancer after surgery.~   "
180330|NCT01204593|"~     Primary Objective:~      To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day,~     tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type~     1 Diabetes Mellitus (T1DM).~      Secondary Objectives:~      To evaluate:~        -  The change of hemoglobin A1c (HbA1c) from baseline to week 12~        -  The percentage of patients with HbA1c < 7% at week 12 and week 24~        -  The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and~          week 24~        -  The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week~          24~        -  The incidence of symptomatic hypoglycemias~        -  Adverse events~   "
180331|NCT01204580|"~     Primary Objective:~      To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA)~     in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M~      Secondary Objectives:~        1. To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in~          type 2 diabetes patients after 8 weeks of therapy~        2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks~          of therapy with Amaryl-M~        3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level~          (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))~        4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of~          therapy with Amaryl-M~        5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change~          after 12 weeks of therapy with Amaryl-M~        6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M~        7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level~   "
180332|NCT01204567|"~     The aim of this study is to evaluate the effect of aerobic fitness training on mental health~     (health-related quality of life),cognitive and physical capacity in older people discharge~     from hospital and to assess if further aerobic training at home enhances the effect.~      Design: Randomized controlled trial conducted at Oslo University Hospital, department of~     Medicine in conjunction with Oslo University College. The subjects will be randomized into~     one intervention group (training group) or one control group.~      Outcome measure:~      Health-related quality of life Physical function Cognitive capacity Physical activity Body~     composition Physical activity level~   "
180333|NCT01204554|"~     The aim of the present study is to assess the microcirculatory changes in the distal part of~     the perforator flap using ICG fluorescence angiography.~   "
180334|NCT01204541|"~     This study seeks to evaluate a novel endpoint for future dry AMD clinical trials.~   "
180335|NCT01204528|"~     To investigate whether treatment with a vitamin-D receptor activator is able to improve~     important markers of cardiovascular risk.~   "
180336|NCT01204515|"~     Children and adults commonly suffer from recurrent abdominal (stomach) pain. One type is~     called irritable bowel syndrome (IBS). IBS in adults and children is one of the most common~     and costly health care problems in the US. Some children have pain frequently (recurrent~     pain) while others rarely have pain. The investigators are conducting this study to help us~     answer questions about the causes and treatments, and management of IBS in children.~      The purpose of this study is to find out if there is more than one type of IBS in children.~     If there is, this will be important in deciding the best treatments. The investigators also~     want to learn how children with IBS differ from those who do not have recurrent abdominal~     (stomach) pain.~   "
180337|NCT01204502|"~     Bone marrow or blood stem cell transplantation is used to treat a wide range of~     life-threatening conditions. T lymphocytes carried in the graft have powerful beneficial~     effects and play a vital role in the eradication of leukaemia and in fighting infection, but~     can also damage healthy tissues and cause graft-versus-host disease (GVHD).~      To safeguard against GVHD, the investigators propose modifying T cells to encode a 'switch'~     so that they can be eliminated if problems arise.~      Children receiving half-matched (haploidentical) transplants from a parent are most likely to~     benefit from this strategy. At present these patients receive blood stem cells from a parent,~     but the T cells are removed because the risk of serious GVHD is unacceptable. This means that~     they are much more likely to suffer from life threatening infections or experience a relapse~     of leukaemia. The investigators want to use gene therapy to produce safe T cells which can~     be used to strengthen the transplant and prevent these serious complications.~   "
180338|NCT01204489|"~     Study aims to pilot a family-centred tailored nutrition intervention at child welfare~     clinics, targeting the previously observed dietary defaults of Finnish children.~   "
180339|NCT01204476|"~     This phase I trial studies the side effects and best dose of cixutumumab when given together~     with everolimus and octreotide acetate in treating patients with advanced low- or~     intermediate-grade neuroendocrine cancer. Monoclonal antibodies, such as cixutumumab, may~     find tumor cells and help carry tumor-killing substances to them. Everolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide~     acetate may interfere with the growth of tumor cells and slow the growth of neuroendocrine~     cancer. Giving cixutumumab together with everolimus and octreotide acetate may be a better~     treatment for neuroendocrine cancer.~   "
180340|NCT01204450|"~     RATIONALE: Drugs such as temsirolimus and valproic acid may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Valproic acid may also stop the growth~     of solid tumors by blocking blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and the best dose of temsirolimus~     when given together with valproic acid in treating young patients with relapsed~     neuroblastoma, bone sarcoma, or soft tissue sarcoma.~   "
180341|NCT01204437|"~     Although approximately 50% of new diagnosis breast cancers are in patients above the age of~     65, elderly people remain substantially under-represented in clinical trials, and therefore~     are under-treated. A recent trial of the CALBG in patient's ≥ 65 years with medium risk of~     breast cancer demonstrated an improved disease-free and overall survival for those treated~     with AC or CMF compared to those treated with capecitabine alone.~      The primary aim of the ICE II trial is to determine the compliance and toxicity of epirubicin~     plus cyclophosphamide (EC) or CMF versus nab-paclitaxel plus capecitabine as adjuvant therapy~     in non frail elderly patients.~   "
180342|NCT01204424|"~     The success of dental implants is based on a variety of factors including; surgical~     technique, health of the patient, operator skill and, to a significant part, sufficient bone~     for the placement and integration of dental implants. To that end, the replacement of the~     maxillary posterior teeth have presented a considerable challenge because, after the loss of~     maxillary posterior teeth the quality and quantity of the remaining supporting bone may be~     insufficient to support implants properly or reliably. To overcome the deficiency of~     insufficient vertical bone mass of the maxilla, several surgical techniques have been~     developed to increase available bone mass for the replacement of dental implants by bone~     augmentation.~      The conventional procedure for a sinus lift (Caldwell-Luc procedure) requires preparation of~     a mucoperiosteal flap in the buccal molar region and to cut an oval window in the thus~     exposed bone, without damage to the subjacent maxillary sinus membrane. The procedure is very~     invasive and subjects the patient to great stress as a result of substantial swelling and~     discoloration of up to 10 days, and possibly of pain. This surgical procedure is oftentimes~     referred to as open or classic sinus lift. This technique is fraught with many risks and~     complications because of the limitations of healing potential in the maxillary sinus. In~     spite of these risks many patients undergo this procedure because of the strong desire to~     replace missing maxillary teeth with dental implants.~      An alternative approach to the maxillary sinus from the inferior approach of the alveolar~     ridge utilizing solid cylindrical osteotomes was described by Dr. Summers (crestal sinus~     lift). It is a more conservative approach and is less invasive. It was developed to eliminate~     the risks described above.While this technique is safer, an overzealous use of an osteotome~     during the placement of the regenerative material can result in the perforation of the~     subantral membrane with disadvantages discussed above.~      Dr. Eder has developed an innovative way - the JEDER System - of carrying out a crestal sinus~     lift that substantially reduces the risk of perforating the subantral membrane. This minimal-~     invasive way uses 2 newly developed and successfully patented instruments, the~     Druckkammerknochenfräse DKK and the Sinusvibrationspumpe SVP. Following JEDER Syst. the~     mucous membrane of the mouth is opened from the toothless part of the maxillary crest up to~     the bone and the bone is scraped by a cylindrical cutter in the shape of a tunnel up to~     slightly underneath the maxillary sinus membrane.~      The aim of the study is to assess the efficacy and safety of the JEDER Syst., which was~     already demonstrated in 50 treatment attempts. The results of this study will be used for the~     certification process to enable the declaration of conformity for the market approval.~      The main outcome parameter is the perforation rate of the subantral membrane intraoperatively~     and within 6 weeks after the operation.~      Risk benefit assessment:~      In the present study there will be no additional examinations undertaken compared to patients~     which undergo the conventional procedure. The conventional procedure is associated with a~     risk of membrane perforation and consecutive diseases like infection, swelling and pain. All~     these inconveniences should be avoided by using the JEDER Syst. If the worst case scenario -~     the perforation of the subantral membrane - happens, the conventional method will be used.~     Therefore, the risk-benefit assessment~   "
180357|NCT01204229|"~     In the proposed project the investigators will develop and test a novel brief intervention~     targeting college students who drink heavily to cope with anxiety and depression, a behavior~     that increases risk for the development of alcohol dependence.~   "
180343|NCT01204411|"~     The purpose of the study is to determine whether the artesunate-amodiaquine combination is~     effective in treating uncomplicated Plasmodium falciparum malaria in children with severe~     acute malnutrition.~      Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and~     mortality in malnourished children. Malnutrition is known to have a modulating effect on the~     incidence of malaria infections, its severity and effectiveness of treatments. However,~     little data exists on antimalarial drug efficacy in malnourished children.~     Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans~     Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine~     is based on non malnourished children. The aim of this study is to measure the clinical and~     parasitological efficacy in severely malnourished children.~      The study is consistent with the standard WHO protocol for monitoring antimalarial drug~     efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except~     for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of~     being an exclusion criteria. The study will encompass a pharmacokinetic part that will~     provide important information on the absorption of the drug.~   "
180344|NCT01204398|"~     The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in~     the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic~     blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan~     80mg/Amlodipine 5mg in patients with moderate to severe hypertension~   "
180345|NCT01204385|"~     The purpose of the study is to identify the bacterial aetiology of acute otitis media~     episodes in young children aged ≥ 3 months to < 5 years in Saudi Arabia.~   "
180346|NCT01204372|"~     GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and~     tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line~     chemotherapy in metastatic pancreatic cancer patients.~      The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30~     min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks~     followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for~     three weeks followed by one week of rest.~      Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then~     at 2 mg/kg over 30 min. for the subsequent infusions.~      Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.~      The patients will be subjected to research for the EGFR, HER2 and KRAS status.~   "
180347|NCT01204359|"~     Iodine 131 (131I） treatment on Graves disease and Graves ophthalmopathy relationship has~     always been the focus of debate. Majority view is that the current treatment does not~     increase 131I Graves ophthalmopathy, therefore,Graves disease associated with exophthalmos is~     not a contraindication of 131I treatment. While treatment with corticosteroids, a timely~     corrective measures to be effective in preventing Graves ophthalmopathy adverse effects. But~     the merger with severe proptosis in patients with Graves , especially infiltrative~     exophthalmos , the application of 131I treatment will induce or aggravate not yet reached~     consensus, so, the 131I treatment is still very careful , mainly due to plaque prospective~     study and visual assessment is not lack of uniform standards, and a variety of factors~     (including smoking, work status, and 131I treatment of thyroid doses, etc.) may also~     interfere or influence the ultimate effect of 131I on the Graves ophthalmopathy. In the view~     of this situation Graves disease patients with Graves ophthalmopathy could be 131I treatment~     or not, how to dose adjustments, and the use of which required treatment with systemic issues~     such as research, explore treatment exophthalmos reduction and mitigation of increased~     proptosis reasonable treatment of symptoms. To further promote the standardization of 131I~     treatment of Graves disease on basis.~   "
180348|NCT01204346|"~     Mentalisation based treatment (MBT) for young people with co-morbid depression and emerging~     personality disorder will be more effective in a day/inpatient setting than treatment as~     usual.~   "
180349|NCT01204333|"~     Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be~     beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a~     poor prognosis despite treatment with heparin. Published experience with ET is promising, but~     only based on case series and not on controlled trials.~      Objective: The main objective of the TO-ACT trial is to determine if ET improves the~     functional outcome of patients with a severe form of CVT~      Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized,~     open-label, blinded endpoint (PROBE) trial.~      Study population: Patients are eligible if they have a radiologically proven CVT, a high~     probability of poor outcome (defined by presence of one or more of the following risk~     factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the~     deep cerebral venous system) and the responsible physician is uncertain if ET or standard~     anti-coagulant treatment is better.~      Intervention: Patients will be randomized to receive either ET or standard therapy~     (therapeutic doses of heparin). ET consists of local application of alteplase or urokinase~     within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke~     scale and relevant laboratory parameters will be assessed at baseline.~      Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most~     important secondary outcomes are the mRS, mortality and recanalization rate at 6 months.~     Major intra- and extracranial hemorrhagic complications within one week following the~     intervention are the principal safety outcome. Results will be analyzed according to the~     intention-to-treat principle. Assessment of study endpoints will be carried out according~     to standardized questionnaires by a blinded neurologist or research nurse who is not involved~     in the treatment of the patient.~      Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82 in~     each treatment arm) have to be included (two-sided alpha, 80% power).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Included patients may benefit directly from ET. Complications of ET, most~     notably intracranial hemorrhages, constitute the most important risk of the study.~   "
180350|NCT01204320|"~     This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or~     paclitaxel-eluting stent implantation in patients with stable or unstable angina with the~     evaluation of restenosis by Quantitative Coronary Analysis.~   "
180351|NCT01204307|"~     To compare the differential influence of 1st line doublet chemotherapy containing Docetaxel~     versus Pemetrexed on clinical efficacy of Erlotinib as a second line therapy in patients with~     relapsed or progressed non-squamous NSCLC.~   "
180352|NCT01204294|"~     The objective of the current study is to investigate the safety and efficacy of linagliptin~     (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes~     mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one~     approved antidiabetic drug.~   "
180353|NCT01204281|"~     To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+)~     (objective 80% gain) as main ventilatory support in early stage of critically ill patients in~     comparison with standard volume-assist control ventilation (ACV).~   "
180358|NCT01204216|"~     Prevention of complications in veterans with diabetes depends heavily on assessment of blood~     glucose and HbA1c. The HbA1c is a blood test that measures the exposure of hemoglobin (Hb) to~     a person's average blood glucose over the lifespan of a red blood cell (RBC). The test is~     heavily relied upon as a measure of blood glucose control. It is normally assumed that all~     people (those with and without diabetes) have a narrow range of red blood cell survival. It~     has been recently shown that this is not a valid assumption.~      A more precise test of red blood cell survival, using a biotin label method, demonstrated a~     substantial difference of red blood cell survival among otherwise normal people. There is~     sufficient difference in red blood cell survival to alter the estimate of glycemic control~     from the HbA1c test by as much as 30 per cent. This introduces concern that HbA1c values do~     not mean the same thing in a significant number of people.~      Although the evidence is clear that there is variation in RBC survival among people,~     attributing this variation to differences between individuals depends on answering several~     simple questions which surprisingly remain unanswered: whether RBC survival is stable over~     time within an individual and whether blood glucose control affects its stability. Therefore,~     the goal of the proposed studies is to define these characteristics.~   "
180359|NCT01204203|"~     The primary objective of this trial is to determine the response rate of single agent~     zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria~     and the EORTC tumor response criteria for 18F-FDG PET scans.~   "
180360|NCT01204190|"~     The primary objective of this trial is to examine whether ovulation is suppressed after use~     of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD)~     for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones~     produced by your body) will be measured and transvaginal ultrasound examinations will be~     conducted at regular intervals. In addition, the concentrations of the administered hormones~     EE and GSD in blood will be determined in regular intervals.~      With regard to the tolerability of the hormone patches subjects will be asked regularly how~     they feel and blood pressure, pulse and body weight will be determined. In addition, blood~     and urine safety examinations will be conducted at defined timepoints.~   "
180361|NCT01204177|"~     This study investigates the safety and efficacy of the combination therapy with BAY86-9766~     and sorafenib in patients with liver cancer. Safety will be determined by laboratory and~     other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by~     disease control rate, overall survival, time to progression, response rate and duration of~     response.~   "
180362|NCT01204164|"~     This is a multicenter, open-label, dose escalation Phase 1 study.~   "
180363|NCT01204151|"~     Children with FXS are predisposed to manifesting a particular profile of intellectual~     strengths and weaknesses, including specific deficits in math, visual-spatial skills,~     executive functioning, and social skills. Until now, intensive behavioral interventions have~     not been targeted to syndrome-specific weaknesses. In the present study we will develop and~     evaluate behavioral strategies to aid skill acquisition in children with FXS.~   "
180364|NCT01204138|"~     A Phase II, single institution, double blind, randomized, placebo controlled, cross-over~     study exploring the safety and efficacy apremilast in patients with active RA with~     concomitant use of TNF inhibition. Following a screening period, patients with active disease~     on stable TNF inhibition will be randomized to receive either apremilast or placebo for a~     period of 12 weeks. At the end of 12 weeks patients will be assessed for efficacy using the~     ACR responder index looking for a 20% improvement, then all patients initially randomized and~     treated in a blinded fashion with apremilast will be crossed over to placebo while those~     patients initially randomized and treated with placebo will be crossed over to apremilast.~     Patients will be followed for an additional 12 weeks on treatment to assess both safety and~     efficacy of this combination treatment. Following 24 weeks of active treatment or early~     termination, patients will undergo a 28 day safety visit.~   "
180365|NCT01204125|"~     Primary Objective:~      - to assess the pathological Complete Response (pCR) rate in the breast of patients treated~     in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+~     weekly paclitaxel, and weekly paclitaxel single agent as calibrator.~      Secondary objectives are:~        -  pCR rate in the breast and axilla,~        -  Radiological/clinical objective response rate (ORR), breast conservation rate, disease~          free survival (DFS), and overall survival (OS), in each treatment arm,~        -  Safety profiles of study combinations and of the single agent reference treatment,~        -  Molecular characteristics of the tumor tissue and peripheral blood mononuclear cells~          (PBMC) and any correlation between the biological activity of the study treatment and~          the disease outcome.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
180366|NCT01204112|"~     The current study is designed to estimate the effect of rifampin (600 mg orally every 24~     hours for 7 days) on pharmacokinetics of single 30 mg dose (CP-690,550) in normal healthy~     volunteers~   "
180367|NCT01204099|"~     Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any~     potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors.~      Phase 2: To determine the antitumor activity and safety of PX-866 in combination with~     docetaxel versus docetaxel alone in patients with NSCLC or SCCHN.~   "
180368|NCT01204086|"~     The purpose of this study is to establish the clinical effectiveness of antidepressants by~     pharmacogenomic approach, and to determine the levels of inflammatory factors between the~     baseline and the end point of the study in Taiwanese major depressive disorder (MDD)~     patients.~   "
180369|NCT01204073|"~     This is the first study in which TAK-441 is administered to humans. The patient population~     will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for~     whom standard treatment is no longer effective or does not offer curative or life-prolonging~     potential. Following completion of the dose escalation study, patients will be enrolled as~     part of 2 expansion cohorts.~   "
180370|NCT01204060|"~     Asthma is one of the most common diseases affecting about 2.5 million Canadians, and can~     result in reduced quality of life and difficulties with work and school. Once the disease has~     become established with irreversible changes in the lungs it can be very difficult to treat.~     Severe asthma although less common than mild asthma uses more healthcare resources.~      The objective of this project is to find out how the changes in the lung develop in severe~     asthma. Once this is known then new treatments can be developed to prevent irreversible~     damage to the lungs.~      Volunteers will have substances sprayed up their nose and then samples collected from their~     nose. Levels of proteins and cells can be measured in these samples. This will give an~     indication of the type of inflammation that occurs.~      The usual method of investigating the changes that occur in asthma is to challenge the lungs.~     Samples have to then be collected from the lungs. This can be in the form of sputum which~     must be treated to break it down to a liquid or washed out during a camera test. These~     methods cause problems with measuring proteins and they are broken down or diluted. Because~     the nose is easily accessible samples can be obtained at many time points. Because the~     samples can be collected directly from the nose the problems with obtaining samples from the~     lung are avoided.~   "
180371|NCT01204047|"~     The specific aims of this study are: 1) to assess the test-retest reliability of a~     modification of an existing wheelchair propulsion assessment and 2) validate the modification~     against traditional measures of physical strength, power, and endurance in a group of persons~     with spinal cord injury (SCI).~   "
180372|NCT01204034|"~     The objective of this study is to evaluate the effect of the combination of formoterol and~     beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using~     Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on~     lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT)~     and Borg CR10 scale will be assessed and the safety will be evaluated.~   "
180373|NCT01204021|"~     There has been a dramatic rise from 46% to 59% in the percentage of households with only 1-2~     people from 1970 to 2000. A 40% increase in the number of people living alone is projected~     for 2010. Social isolation is consistently one of the strongest predictors mortality in older~     adults. Recent research is demonstrating that stress plays an important role linking social~     isolation with poor health. Socially isolated older adults are more likely to feel~     chronically stressed and overwhelmed with everyday life demands. Furthermore, isolated adults~     respond to stress differently, both psychologically and physiologically. Socially isolated~     and lonely older adults show long-term elevations in inflammatory cytokines, which are~     signaling molecules related by immune cells. These Inflammatory cytokines play a role in a~     number of age-related diseases including cardiovascular disease, type-2 diabetes and~     arthritis. Novel, readily useable interventions aimed at decreasing isolation and~     re-calibrating stress responses might be helpful to older adults.~      Tai Chi is an ancient Chinese form of calisthenics that promotes relaxation and decreases~     feelings of stress and as such, it may be a useful intervention for socially isolated,~     stressed older adults. However, its effects on stress responses are unknown. Tai Chi Chih~     (TCC) is a simplified, manualized, readily exportable form of Tai Chi particularly~     well-suited for older adults. This proposed study will test the effects of a TCC intervention~     with socially isolated older adults on loneliness, stress and health outcomes, including~     inflammatory assessment. Tai Chi-naïve participants who perceive themselves as socially~     isolated, as measured by the UCLA Loneliness Scale will be randomized to receive either Tai~     Chi or education control for a 12-week period. Subjects will undergo pre- and~     post-intervention stress assessment, including exposure to a psychological stress task, to~     assess whether Tai Chi affects how subjects physiologically and psychologically respond to~     stress.~   "
180374|NCT01204008|"~     Summary: This is a prospective randomize study to compare conservative and aggressive~     discectomy for treatment of disc herniation with radiculopathy.~      Study hypothesis: The investigators believe that conservative discectomy could preserve a~     higher disc space and has a better long-term outcomes.~   "
180375|NCT01203995|"~     The purpose of this study is to provide testing methods of delivering nutrition and physical~     activity services for weight loss.~   "
180376|NCT01203982|"~     The aim of this study was to measure the effect of moderate and intensive lipid-lowering~     treatment with rosuvastatin on the carotid intima-media thickness (CIMT) as a surrogate~     marker of cardiovascular risk.~   "
180377|NCT01203969|"~     This randomized trial is designed to identify the safety and efficacy of single port~     laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.~   "
180378|NCT01203956|"~     There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when~     using the DeVilbiss AutoAdjust device.~   "
180379|NCT01203943|"~     The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in~     idiopathic pulmonary fibrosis patients.~   "
180380|NCT01203930|"~     This study is to evaluate the safety and clinical activity of idelalisib alone and in~     combination with rituximab in patients with CLL or SLL.~      This Phase 2 study will be the first time that idelalisib is administered to previously~     untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical~     activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity,~     which supports its evaluation in previously untreated patients. The study population is~     limited to patients over 65 years of age because younger patients are generally appropriate~     for standard immunochemotherapy regimens that are highly active. Since the mechanism of~     action of idelalisib is distinct from rituximab, it is hypothesized that the combination will~     be more active than either agent alone. This study will establish initial safety and clinical~     activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of~     this study will establish safety and clinical activity of idelalisib alone in subjects with~     untreated CLL or SLL.~   "
180381|NCT01203917|"~     This study is carried out to see how Caucasian patients with lung cancer which has EGFR~     mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also~     be collected and analysed to confirm that treatment with gefitinib is safe and well~     tolerated.~   "
180382|NCT01203904|"~     The purpose of this study is to confirm the safety profile for long term treatment in~     children aged 5 years and <15 years on bronchial asthma in daily clinical usage/Effect on~     growth rate. Effect on adrenal function. Development of infection diseases by diseases type.~   "
180383|NCT01203891|"~     The objective of the study is to acquire a database of Single Photon Emission Computed~     Tomographic (SPECT) studies of the brains of normal human subjects in resting and~     concentrating states. The database will provide a basis for subsequent investigation of~     meaningful brain differences between clinical and normal subject groups~   "
180384|NCT01203878|"~     The purpose of this study is to explore the effect of treating actinic keratoses of the face~     with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with~     imiquimod alone~   "
180385|NCT01203865|"~     The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro~     planning resource allocation of medical expenditure as well as for identifying demographic~     and ethnic differences of this unique population compared with other western samples. In the~     current study the investigators aim at estimating the prevalence of fibromyalgia in this~     population. For this purpose a two - stage process will be used. First, a population survey~     will be conducted by telephone, screening for widespread pain and fatigue in the general~     population. This survey will use the London Fibromyalgia Epidemiology Study Screening~     Questionnaire. Second, a sample of patients attending the rheumatology clinic will be~     surveyed with this tool and will be examined in order to determine the actual proportion of~     patients fulfilling ACR criteria for fibromyalgia. This will enable us to calculate the~     positive predictive value of the London Fibromyalgia Epidemiology Study Screening~     Questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the~     population.~   "
180386|NCT01203852|"~     There are many medications available for the treatment of high blood pressure (hypertension),~     but finding the right one for a specific patient can be challenging. In fact, it is estimated~     that less than 50% of people with hypertension have their blood pressure under control. The~     hypothesis is that genetic differences between individuals influence their response to~     antihypertensive medications. This study is aimed at determining the genetic factors that may~     influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is~     that through this research, the investigators may someday be able to use an individual's~     genetic information to guide the selection of their blood pressure medicine, leading to~     better control of blood pressure, and less need for the current trial and error process.~   "
180387|NCT01203839|"~     Currently the standard of care is to treat early stage invasive breast cancer or ductal~     carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as~     breast-conserving therapy (BCT). The traditional method of giving radiation therapy after a~     lumpectomy is to the whole breast.~      However the investigators do not know if the whole breast needs to be receive radiation to~     better control your cancer or only a more limited area of the breast surrounding the tumor.~     The purpose of this study is to see the side effects of delivering partial breast irradiation~     (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the~     area of the breast where the cancer was removed. Another purpose of this study is to look~     long term at the rate at which cancer comes back in the same breast after PBI.~      WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial~     breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The~     investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a~     day, five days a week, for 2 weeks.~      In this study the investigators will learn about the good and bad effects of PBI radiation~     therapy. In this study, the investigators will also learn about how the breast looks after~     surgery and radiation therapy.~   "
180388|NCT01203826|"~     This clinical trial studies the long term safety and efficacy of asfotase alfa in children~     with HPP who completed Study ENB-006-09 (NCT00952484).~   "
180389|NCT01203813|"~     Aim 1: To assess whether quality of care for stage 3 chronic kidney disease can be~     substantially improved over 18 months by:~        -  Point of care electronic alerts to primary care physicians recommending risk-appropriate~          care, and~        -  Quarterly mailings to patients providing self management support materials, including~          tailored recommendations based on personalized data from an electronic disease registry~      Aim 2: To assess the relationship between utilization of the intervention components and~     primary care physician attitudes towards both chronic kidney disease management and~     electronic reminder systems.~   "
180390|NCT01203800|"~     In this study the investigators intend to explore the long term significance of BBB~     disruption on the clinical course and the rate of significant recurrent ischemic events in~     patients with a chronic stroke.~   "
180391|NCT01203787|"~     Open-label study to evaluate the safety and tolerability of Sorafenib dose ramp-up (starting~     at a lower dose and then gradually increasing the dose) versus standard Sorafenib dosing in~     subjects with unresectable and/or metastatic hepatocellular carcinoma.~   "
180392|NCT01203774|"~     In this study the investigators would like to test the hypothesis that in diabetic patients~     discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected~     Glargine in terms of diabetes control, compliance, and patient satisfaction and preference.~     The investigators will test this hypothesis in a randomized, crossover trial.~   "
180393|NCT01203761|"~     The experience of illness and hospitalization exerts a great deal of psychological distress,~     one of the most distressful events people might experience throughout their life times.~     Surgery and anesthesia with their accompanying loss of control, fear of being unconscious and~     invaded, and expectation of postoperative pain adds appreciably to that stress and anxiety.~      Current psycho-physiological research has provided evidence on the alarming possibility of~     the aversive affects of hospitalization stress on the patients' already deteriorated physical~     health and marked interference with their recovery.~      As an additional stressor, which may partly be related to the hospital staff, and partly to~     the person's illness and expected surgery is loneliness.~      Loneliness is a painful experience that is, commonly, not embraced and which has consequences~     that are detrimental to one's emotional, physical and spiritual well being.~      The present study explores the qualitative aspects of loneliness (via questionnaires) in two~     patient populations: (1) patients facing surgery, and (2) patients who have already undergone~     surgery. In addition, family members [i.e. those waiting outside of the operating room] will~     be given a questionnaire, and these three groups will be compared to the general population.~   "
180394|NCT01203748|"~     This investigation is designed with the hypothesis that combined PV Antral Isolation and~     Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success~     rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and~     to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.~   "
180409|NCT01203553|"~     Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes~     are mainly implanted via open or laparoscopic approach. The differential impact of these two~     types of surgical technique on recurrence rate will be investigated with this study.~      With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia~     repair will be investigated prospectively. Hernia recurrence is the main outcome measure.~   "
180395|NCT01203735|"~     This is non-randomized phase 2 study to evaluate toxicity and efficacy of VA with concurrent~     chemoradiotherapy (CCRT) containing weekly vinorelbine and cisplatin in patients with locally~     advanced inoperable non-small-cell lung cancer (NSCLC).All patients will be planned for~     three-dimensional conformal RT (3-DCRT). Concurrent weekly vinorelbine and cisplatin and oral~     valproic acid (VA)will be started at the first day of RT. Follow up will be conducted every 3~     months after completion of the study treatment. Toxicity will be assessed using CTCAE, based~     on clinical examination and laboratory tests during the study treatment and at follow up~     visits. Response to treatment will be evaluated using RECIST criteria. Overall and~     progression free survival (OS and PFS) will be estimated using the Kaplan-Meier method.~   "
180396|NCT01203722|"~     If transplantation using mismatched unrelated donors or non-first-degree relatives could be~     performed with an acceptable toxicity profile, an important unmet need would be served.~     Towards this goal, the current study extends our platform of nonmyeloablative, partially~     HLA-mismatched BMT to the use of such donors, investigating up to several postgrafting~     immunosuppression regimens that incorporate high-dose Cy. Of central interest is the~     incorporation of sirolimus into this postgrafting immunosuppression regimen. The primary goal~     is to identify a transplant regimen associated with acceptable rates of severe acute GVHD and~     NRM by Day 100.~   "
180397|NCT01203709|"~     A trial of combination of two drugs for the treatment of refractory lupus nephritis.~   "
180398|NCT01203696|"~     Clopidogrel can reduce risk of cardiovascular disease by inhibiting platelet aggregation. It~     is metabolized to an active drug by a liver enzyme. Its efficacy may be measured by blood~     sampling for platelet activity, analyzed by VerifyNow device. Calcium Channel blocker (CCB)~     is also commonly used for blood pressure and anginal control in these patients.~     Dihydropyridine group of calcium channel blocker (e.g. amlodipine) inhibits this enzyme.~     There are observational studies reporting dihydropyridine CCB reducing clopidogrel effect,~     but the clinical implication is unclear.~      This study test the hypothesis that there is no significant effect of dihydropyridines CCB on~     clopidogrel response compared with control. After giving consent, patients with suboptimal~     blood pressure or anginal control will be randomized to receive either dihydropyridine CCB or~     non-CCB as placebo. These patient will be follow-up in 1 month.~   "
180399|NCT01203683|"~     The purpose of this study is to determine whether completing a computer-based program alters~     changes how the brain processes emotional information and improves symptoms of depression.~   "
180400|NCT01203670|"~     The aim of the study is to evaluate renal and digestive tolerance of a food supplement,~     phytalgic, on elderly volunteers.~   "
180401|NCT01203657|"~     Although a number of studies have examined the effects of Tai Chi in older adult populations,~     few have methodically assessed its effects on vitality, fatigue and physical activity. Some~     studies have shown that fatigue relates to negative mood and poor health-related quality of~     life in older persons.~      Tai Chi is an ancient Chinese form of calisthenics that utilizes the body's internal energy~     (chi), mind, and breathing; which may be a useful exercise for older adults in increasing~     their activity level. A twenty-four of Yang style of Tai Chi is a simple form of Tai Chi that~     is particularly well-suited for older adults. This proposed study to investigate the effects~     of a Tai Chi intervention on decreasing fatigue level, and increasing level of activity in~     healthy older adults.~      The investigators research group has focused on the Tai Chi as a strategy to reduce stress~     and improve sleep, and their preliminary evidence suggest it strongly affects energy level~     and vitality. The investigators are focused on taking this intervention into the community~     testing its efficacy. The investigators preliminary data shows that Tai Chi is of benefit to~     older adults; however, this study will test whether their research findings are generalizable~     to community settings.~      Tai Chi-naïve participants from Culver City Senior Center will receive a 10-week Tai Chi. The~     investigators will compare this group to a wait-list control group. All subjects will receive~     a packet of questionnaires of pre- and post-intervention vitality, fatigue and health-related~     quality of life. Subjects will also be given an activity monitor to wear for 2 days before~     they start the Tai Chi class and for 2 days after they complete the class, to determine if~     there is a change in general physical activity level.~   "
180402|NCT01203644|"~     The primary objective of this study was to determine the appropriate dose of SKY0402 for the~     management of postoperative pain following inguinal hernia repair. This study evaluated the~     safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine~     HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair.~     Study drug was administered by surgical wound infiltration at the end of the hernia repair~     procedure.~   "
180403|NCT01203631|"~     This trial is conducted in Europe and North America. The aim of the trial is to assess~     disease activity and safety in subjects with moderately to severely active Crohn's disease~     (CD) when treated with NNC 0142-0000-0002.~   "
180404|NCT01203618|"~     The purpose of this study is to evaluate whether therapy with farletuzumab is effective and~     safe in the treatment of resectable, non-functioning pituitary adenomas.~   "
180405|NCT01203605|"~     The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study of~     peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery.~      Participating centres throughout Europe will contribute routine clinical data describing all~     eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will~     then be followed until hospital discharge (or for a maximum of 60 days) for duration of~     hospital stay and hospital mortality. Routine clinical data will also be collected for those~     patients admitted to critical care at any stage after surgery but during the same hospital~     admission. Specific objectives are to describe clinical outcomes and standards of~     peri-operative care for patients undergoing non-cardiac surgery in Europe.~   "
180406|NCT01203592|"~     The study tests the notion that patients suffering from certain types of congenital~     myasthenic syndromes are benefitted by the use of Albuterol at doses used in clinical~     practice.~   "
180407|NCT01203579|"~     The purpose of this study is to assess the value of EarlyCDT-Lung test and CT scan both in~     lung cancer detection and potential health economic outcomes.~   "
180408|NCT01203566|"~     LESS laparoscopic appendectomy is associated with less pain than conventional 3-port~     laparoscopic appendectomy.~   "
180412|NCT01203514|"~     This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in~     infants of <1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early~     erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For~     infants 1,001-1,250g birth weight, we tested whether early erythropoietin (Epo) and iron~     therapy would decrease the percentage of infants who received any transfusions.~   "
180413|NCT01203501|"~     This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in~     extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal~     Research Network Generic Database whose mothers were given prenatal MgSO4, data were~     prospectively collected on maternal/infant conditions and magnesium exposure (including~     indications, timing and duration of exposure).~   "
180414|NCT01203488|"~     This multi-site, randomized trial was conducted to determine the safety and effectiveness of~     a higher dose of vitamin A and determine if this would increase the rate of survival without~     bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights~     from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours~     of age were enrolled. Subjects were randomized to either the Vitamin A or a control group.~     Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on~     Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure~     rather than placebo injections.~   "
180415|NCT01203475|"~     This study was a multicenter, prospective cohort study to define postnatal longitudinal~     growth for very low birth weight (VLBW) infants. The objectives were: 1) to develop postnatal~     growth curves for VLBW preterm infants that would permit an assessment of growth velocity; 2)~     to relate growth velocity and nutritional practices (duration of parenteral nutrition, age at~     first enteral feeding, and age at full enteral feeding); 3) to compare growth velocity in~     infants who are small-for-gestational age (SGA) with infants who are~     appropriate-for-gestational age (AGA); and 4) to relate growth velocity to several common,~     major morbidities, including chronic lung disease (CLD), nosocomial infection (or late-onset~     infection) and necrotizing enterocolitis (NEC). These growth data may be useful in~     identifying preterm infants who are growing slowly despite current nutritional support and in~     designing and performing clinical trials of nutritional interventions.~   "
180416|NCT01203462|"~     The purpose of this study is to determine the effect of probiotic supplemented yogurt in~     reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two~     yogurts will be administered, one containing a specific strain of probiotic in the~     Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized that~     subjects receiving the probiotic supplemented yogurt will experience reduced CTT and improved~     gastrointestinal comfort and quality of life compared to those receiving the non-probiotic~     supplemented yogurt.~   "
180417|NCT01203449|"~     The primary purpose of this study was to evaluate the accuracy of gestational age (GA)~     estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate~     obstetric estimates of GA. Secondary purposes were: (1) to compare the accuracy of GA~     estimates derived from the NBS, the original Ballard score, and the physical items of the~     original Ballard score and (2) to compare these measures of GA and best obstetric estimates~     of GA as predictors of survival, morbidity, and hospital stay among infants <28 weeks'~     gestation and among very low birth weight infants in general.~   "
180418|NCT01203436|"~     The purpose of this trial was to determine the efficacy and safety of supplemental~     therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce~     the probability of progression to threshold ROP and the need for peripheral retinal ablation.~   "
180419|NCT01203423|"~     This study was an observational study to estimate the prevalence of Persistent pulmonary~     hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory~     disease.~   "
180420|NCT01203410|"~     The objective of this study was to describe total bilirubin production in healthy term~     infants as a means of understanding the differences in jaundice pigment production associated~     with various common clinical circumstances.~   "
180421|NCT01203397|"~     Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate in the~     treatment of superficial varicose veins~   "
180422|NCT01203384|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.~   "
180423|NCT01203371|"~     The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and~     Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of~     patients with benign prostatic hyperplasia.~   "
180424|NCT01203358|"~     The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal~     (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal~     respiratory distress syndrome.~   "
180425|NCT01203345|"~     A controlled clinical trial was conducted at eight participating centers between January 1,~     1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin~     group or a control group. There were two phases to the study (see below). During phase 1 the~     control infants received infusions of placebo. During phase 2 the control infants received no~     infusion therapy.~   "
180439|NCT01203163|"~     Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn),~     oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated area~     (a tear or puncture of the tissue), have been identified in research studies evaluating~     photodynamic therapy (PDT) with porfimer sodium. Because of the low incidence of the disease~     or the variation in the occurrence of these adverse reactions among different indications, it~     is difficult to determine the occurrence and frequency of these safety issues in routine~     clinical practice.~      This post-marketing safety surveillance registry is set-up to evaluate the safety of PDT~     using porfimer sodium. A registry allows the collection of data to evaluate real-world~     results in the practice of medicine. The registry will monitor the patient's health and any~     events, with a main focus on photosensitivity, oesophageal stenosis, and perforation of the~     treated area. This registry will involve 500 patients, across 20 to 36 hospitals in the US~     and Europe, scheduled to receive an injection of porfimer sodium with PDT for the treatment~     of lung cancer, esophageal [food pipe] cancer, or high-grade dysplasia (HGD) (precancerous~     change in the food pipe tissue) in Barrett's esophagus.~   "
180426|NCT01203332|"~     The proposed research will include adolescent and young adult Hispanic/Latino men who have~     sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13~     ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial~     services to the target group. In 10 of the 13 sites, comparisons will be made between~     alternative venue-based testing (AVT) and social and sexual network-based interviewing and~     HIV testing (SSNIT) strategies to assess which, among these approaches, is the most effective~     means for identifying undiagnosed human immunodeficiency virus (HIV) in young, at-risk~     Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for identifying~     undiagnosed HIV in our target group of adolescents and young adults. All study participants~     will complete an audio computer-assisted self-interview (ACASI) and undergo HIV screening.~     Participants with presumptive HIV positive screening results will be referred to the local~     AMTU for confirmatory testing, post-test counseling and referrals for linkage to HIV medical~     care. Linkage to care for ATN 096 study participants will be conducted in accordance with the~     Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of~     Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Program (ATN 093), a~     collaboration of the CDC and NICHD/ATN, to ensure that youth who test positive for HIV as~     part of this protocol are linked with treatment and care.~   "
180427|NCT01203319|"~     This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained~     from the phase 1 clinical trial. The purpose of this study is to further evaluate the~     immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16~     and older who failed to respond to routine administration of 10mcg recombinant hepatitis B~     vaccines and to explore the optimizing immunizing dose and immune procedure.~   "
180428|NCT01203306|"~     Well differentiated neuroendocrine (NE) carcinomas have low proliferative activity and~     conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent~     administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties.~     Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing~     metronomic chemotherapy and antiangiogenetic drugs. This is a national, multicenter, phase II~     study.~   "
180429|NCT01203293|"~     The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy~     (CBT) based interventions in general health settings that are delivered to reduce Generalized~     Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve health-related~     quality of life.~   "
180430|NCT01203280|"~     Most boxing injuries occurs over head and neck which leads to potentially acute or chronic~     head and neck injuries. Patients with whiplash injury has been reported, reflected by~     increased body sway and reduced ability to overcome challenging balance tasks. The purpose of~     this research is to evaluate the fitness and balance outcomes between the boxers and the~     control group, and boxers undergoing posterior-neck icing effects.~   "
180431|NCT01203267|"~     The purpose of this study is to evaluate the pathological complete response (pCR) rate in~     breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.~   "
180432|NCT01203254|"~     The purpose of this study is to assess the efficacy of cholestagel to reduce the frequency of~     soft and liquid stools per day in patients with CD in clinical remission with symptoms of BAM~     and to assess the improvement in stool consistency and quality of life in these patients and~     to assess the safety of cholestagel.~   "
180433|NCT01203241|"~     The aim of the present study is to assess whether left atrial roof ablation adds any benefit~     in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.~   "
180434|NCT01203228|"~     In this trial dose reduced conditioning is compared to standard conditioning followed by~     allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or~     secondary AML.~      Conditioning is the very high dose chemotherapy treatment that is given in the days before~     the stem cell transplant.~      The hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality from~     40% to 20% at one year after allogeneic stem cell transplantation.~   "
180435|NCT01203215|"~     Print-based interventions, specifically interventions that are theoretically-based have been~     shown to be effective for individuals. These types of interventions are of particular~     importance for those individuals who, due to transportation, work, family, social, or~     financial demands have difficulty participating in face-to-face programs. Therefore, we~     decided to test 2 such print based programs for women.~   "
180436|NCT01203202|"~     The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable~     and effective in the treatment of premature ejaculation.~   "
180437|NCT01203189|"~     The aims of this study are to compare the effectiveness of antifungal foam versus antifungal~     shampoo and determine patient compliance and satisfaction with both vehicles among African~     American females with dandruff practicing less than once weekly hair washing.~   "
180438|NCT01203176|"~     The prevalence of endometrial polyp is 24% in the general population but is much higher in~     postmenopausal women. The incidence of malignant or pre-malignant findings in endometrial~     polyps ranges from 2 to 10% in menopausal women.~      Removal of endometrial polyps in postmenopausal symptomatic women is the standard of care,~     same goes for asymptomatic women with risk factors for endometrial malignancy, however~     treatment of asymptomatic postmenopausal women with endometrial polyp but no risk factors is~     disputable.~      In light of ambiguity in literature regarding the rate of malignant and pre-malignant~     findings in polyps in asymptomatic post-menopausal women, the investigators are asking to~     conduct a prospective study in order to evaluate and compare the incidence of malignant and~     pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial~     polyp~   "
180440|NCT01203150|"~     This hypothesis-driven study will investigate effects of physical activity with or without a~     nutrient supplement known to increase body lean mass in adults with chronic paraplegia who~     have clusters of obesity and obesity-related secondary complications.~   "
180441|NCT01203137|"~     Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested~     as independent prognosticator for predicting long-term prognosis in patients with isolated~     severe TR undergoing corrective surgery We attempted to explore whether early postoperative~     echocardiography provides additional prognostic information on top of preoperative clinical~     and echocardiographic variables.~   "
180443|NCT01203111|"~     Primary Objective:~      To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin~     glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week~     24 (visit 10).~      Secondary Objectives:~        1. Percentage of patients with HbA1c < 7% at week 24.~        2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event~          at week 24.~        3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week~          0, week 12 and week 24.~        4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose /~          kg (U/kg) will be calculated at week 24.~        5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at~          week 0, week 12 and week 24.~        6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal~          symptomatic, severe and nocturnal severe) will be evaluated during the treatment period.~          7-Adverse events.~   "
180444|NCT01203098|"~     The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b~     15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after~     elective total hip arthroplasty.~   "
180445|NCT01203085|"~     The primary goal of this project is to develop and test a Charcot Marie Tooth disease (CMT)~     Pediatric Scale for use in evaluation in natural history CMT study.~   "
180446|NCT01203072|"~     The objective of this study is to assess the efficacy, safety and dose-response relationship~     of DU-176b compared with placebo for the prevention of venous thromboembolism in patients~     after elective total knee arthroplasty.~   "
180447|NCT01203046|"~     Abdominal penetrating trauma represents a frequent cause of consult into emergency rooms in~     Venezuela. Accidents and violence at Hospital Miguel Perez Carreño along april 2009 were~     represented by gunshots and stabbing wounds which 8th. and 18th cause for medical attention~     respectively within a total of 76 cases. Likewise gunshot wounds reach the first cause of~     morbility into general surgery services with 21 cases and the stabbing wounds the 12th cause~     with 12 cases within the same period.~      Early therapy is defined as the antibiotic dose administrated within the first 12 hours after~     the trauma. Abdominal cavity contamination by micro-organism is not synonymous of stablished~     infection, the extension of contamination and intensity of reaction should be enough in order~     to allow the inflammatory focus developing.~      Abdominal cavity needs at least 12 - 24 hours of exposure to the infectious material to allow~     the stablishment of such infection. Origin and amount of contaminant material influence the~     size of inoculated bacteria and the speed that infection develops.~      There is not an absolute criteria to determine when intrabdominal contamination progress to~     an established infection. Surgeons decides the must adequated therapy according to clinical~     history, radiology tests and findings during surgery.~      Selected patients for early antibiotic therapy in penetrating abdominal trauma includes those~     with traumatic intestinal wounds with less than 12 hours of evolution and those with~     gastroduodenal wounds lesser than 24 hours as well.~      There are different antibiotics indicated for intrabdominal infections. Ertapenem is a low~     resistance carbapenem with a broad spectrum into microbial flora presenting in penetrating~     abdominal trauma. Its media life and blood therapeutic levels allows the use of an unique~     dose within the first 24 hours of trauma.~      This research protocol has been designed according to established patterns for clinical~     investigation and our goal is to achieve criteria in decision making about antibiotic~     administration in patients with penetrating abdominal trauma and evaluate the security of an~     Early short term antibiotic therapy with Ertapenem 3 days vs 7 days, decreasing hospital~     costs related to indiscriminate use of antibiotics.~   "
180448|NCT01203033|"~     Treatment options and clinical outcomes for acute myeloid leukemia (AML) have not improved~     for more than 40 years. AML patients are still suffering from receiving costly, ineffective~     chemotherapy treatments with very high chances of bad side effects. The purpose of this study~     is to take a look at leukemia cells to see if the investigators can learn what makes them up~     and makes them aggressive and hard to treat. We want to use this information to create new~     treatments that the investigators hope are more effective and less harmful for AML patients.~      Newly diagnosed, relapsed or refractory (post induction therapy) AML patients that are 18~     years of age or older will have bone marrow and blood samples taken for their regular AML~     treatment. When these tests are done during their treatment the investigators will need to~     get some extra blood and bone marrow to do this research. The patients will not be asked to~     have an extra needle stick or bone marrow biopsy to get these samples. The patients will have~     the same number of blood and bone marrow tests whether they participate in this study or not.~     We will only need to get about two teaspoons of blood and two teaspoons of bone marrow each~     time the patient has these tests during their regular AML treatment. The research the~     investigators do with these sample will not decide or change the care the patients get for~     their AML.~   "
180449|NCT01203020|"~     This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT)~     followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine~     in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.~   "
180450|NCT01203007|"~     The purpose of this study is to assess whether a tailored diet, eliminating antigens to which~     IgA nephropathy patients have demonstrated sensitivity, will have an effect on proteinuria,~     renal function and other immunological variables.~   "
180451|NCT01202994|"~     Alzheimer's disease (AD) is the most common cause of progressive cognitive decline in the~     United States. AD is characterized by severe impairments in learning, memory and other~     cognitive abilities that significantly interfere with daily functioning. The neuropathologic~     hallmarks of AD consist of neuritic plaques, neurofibrillary tangles, and selective neuronal~     cell loss. Amyloid plaques, which contain Abeta protein, are believed to play an integral~     role in the development of AD. Elevated levels of Abeta in the brain are also correlated with~     cognitive decline.~      Alzheimer's (AD) develops insidiously, making it difficult to identify early, yet treatment~     is most effective when begun during the early stages of the disease. Thus, it has become~     important for researchers to identify markers of early AD. This project will examine the~     relationship between four potential markers that may indicate the early development of AD:~        1. Mild cognitive impairment (MCI)or normal cognition~        2. Practice effects~        3. Amyloid plaque binding on 18F-PIB PET~        4. Glucose hypometabolism on FDG PET~      This project will recruit 25 subjects from an ongoing community-based study of memory and~     practice effects in cognitively normal, community-dwelling individuals who are age 65 and~     over (NIA #5K23AG028417-05). Each subject will undergo positron emission tomography (PET)~     with both 18F-Flutemetamol and FDG.~      The overall objective of this companion project is to study the biodistribution and binding~     of 18F-Flutemetamol in these subjects using PET imaging, which will provide biological~     evidence to support the overall hypothesis that failure to benefit from practice on a~     learning paradigm is an early marker of AD.~   "
180523|NCT01202058|"~     As a result of the implementation of Protocol Am3.0, the design and objective of the NEVO II~     trial were changed to focus on the safety follow-up of the 103 NEVO™ subjects. Although this~     trial started interventional, the remainder of the study will be observational.~      The objective of this prospective, observational study is to ensure the safety and the~     wellbeing of subjects treated with the NEVO™ SES.~   "
180452|NCT01202981|"~     This study will assess the impact of IOL glistenings on visual quality and function in~     patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits~     glistening formations. The primary objective is to determine if random light scattering~     (measured by C-Quant)correlates with severity of glistenings, other objective measures of~     visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with~     glare), and subjective measures of patients' perceptions of their visual quality after~     cataract surgery (quality of life survey, reports of symptomology and satisfaction).~   "
180453|NCT01202968|"~     It was well known that long term intubation caused a various kind of abnormal presentations~     of dysphagia such as the increased aspiration risk, the decreased gag reflex, mucosal~     pathology, the airway stenosis and so on. It was thought that the freezing and impaired~     proprioception to be developed as a result of dis-use around the pharynx and the larynx while~     intubation was one of the reason.~      Preemptive swallowing manual stimulation applied on the oral cavity to avoid the vicious~     cycle of dis-use was reported to improve dysphagia after extubation.~      Neuromuscular electrical stimulation have been utilized for a wide variety of dysphagia of~     multiple causes of neuro-muscular disorder.~      Supposing that preemptive transcutaneous neuromuscular electrical stimulation to be delivered~     to the muscles of being involved in swallowing could decrease the degree of dis-use during~     intubation so that it could reduce the occurence and severity of dysphagia developed after~     extubation, the investigators plan to perform randomized prospective double blind placebo~     controlled clinical interventional study.~   "
180454|NCT01202955|"~     The goals of this within-subject pilot study are: (1) assess the feasibility and safety of~     administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and~     (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms~     that promote relapse. A secondary exploratory goal is to assess whether these effects may be~     more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT~     val/val.~   "
180455|NCT01202942|"~     The proposed research extends previous research on Quest® cigarette smoking behavior by~     testing whether compensatory smoking occurs as cigarette nicotine level decreases, and~     whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in~     210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at~     least five years and are not currently interested in quitting, but interested in trying a new~     cigarette product. Participants will be randomized to one of three conditions: 1) smoke their~     own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing~     cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where~     they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages~     beginning with a 5-day preferred own brand cigarette smoking phase for all participants,~     followed by one of the three cigarette conditions. For those smoking Quest® cigarettes,~     cigarette nicotine level will change every 10 days, either in a step-down or random fashion.~     The primary behavioral outcome is smoking topography, a quantitative measurement of smoke~     exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine~     samples to assess carcinogen exposure, specifically NNAL~     (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled~     breath condensate will also be collected at the laboratory visits. At the initiation of the~     study, participants will view the Quest® print advertisement and complete a survey related to~     product expectations in order to determine the impact marketing and advertisement has on~     beliefs, attitudes and behaviors related to Quest® cigarettes.~   "
180456|NCT01202929|"~     High Resolution Manometry is a new technology that utilizes 36 solid state sensors on a thin~     catheter spaced at 1-cm intervals. One can more effectively measure the pressure of the~     esophagus. It includes a sophisticated software to display the pressures data as color~     topography plot using time, length of the esophagus and pressure within the entire esophagus.~     It is unclear if this technology improvement actually correlates with patient's symptoms.~   "
180457|NCT01202916|"~     Congenital heart diseases (CHD) are the first cause of congenital malformations with an~     incidence of 8 for 1000 births. Within the two past decades prenatal diagnosis has had a~     great impact on CHD prevalence. France was the first country to show the impact of prenatal~     diagnosis on the lowering prevalence of the most severe CHD, the hypoplastic left heart~     syndrome. Since the 90's, great advances in pediatric cardiac surgery, intensive care and~     cardiac catheterization have led to lower mortality and morbidity in this population.~     Prevalence of  GUCH , grown-ups with congenital heart disease has thus been significantly~     increasing. For all these reasons and as the investigators can also see in other many chronic~     diseases, new questions about the quality of life of these patients arise among patients,~     parents/future parents, doctors, patients associations, and public health organizations. In~     2007 French government promoted a national public health plan for improvement of the quality~     of life among patients suffering from chronic illnesses. First step of such a program is to~     correctly evaluate this quality of life. Indeed the concept of quality of life (QoL)~     remains subjective and difficult to appreciate and measure. Its analysis requires the use of~     validated questionnaires. Few questionnaires are available in Europe, especially in~     pediatrics. Few studies in this population have been led and no comparative study to a~     control randomized group has been published. The investigators study aims to analyze in the~     investigators tertiary care center in pediatric cardiology the QoL among 8 to 18 year old~     French patients with CHD using a validated questionnaire (Kidscreen™) and to compare it to~     same aged healthy children. The investigators secondarily intend to :- validate the French~     version of one reference pediatric QoL questionnaire used in most publications in the USA~     (PedsQL™). - compare the QoL to the severity of the CHD using a published semi-quantitative~     score.- compare the QoL to the severity of the CHD using the results of routine exercise~     tests (VO2 max) performed routinely in the investigators center. The investigators hypothesis~     are that :- Quality of life of most common and not severe CHD is close to that of healthy~     children. - QoL of severe CHD is not so well correlated to severity of CHD.- PedsQL™ is a~     simple questionnaire which can be used in France in routine follow-up of children with CHD.~   "
180458|NCT01202903|"~     This study will assess the efficacy, safety and tolerability of omalizumab, compared to~     placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic~     asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4~     therapy.~   "
180459|NCT01202890|"~     This study will test the feasibility of combining 3 drugs, Revlimid with Doxil and~     Bevacizumab,and gather preliminary data on the potential activity of the combination in~     patients with platinum resistant/refractory ovarian cancer.~   "
180460|NCT01202877|"~     The goal of this clinical research study is to learn if the combination of PKC412 (also~     called Midostaurin) and 5-azacytidine can help to control refractory or relapsed acute~     leukemia and MDS. The safety and best dose of the combination of the drugs will also be~     studied.~   "
180461|NCT01202864|"~     The purpose of this study is to find risk factors for hemorrhagic stroke, specifically~     intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics.~   "
180462|NCT01202851|"~     The goal of this behavioral research study is to compare two different forms of relaxation~     programs that will include stretching and relaxation techniques, in order to learn if and how~     well they may help to improve physical and emotional well-being. This will be tested in~     patients with breast cancer who are receiving radiation therapy. For comparison purposes,~     there will also be a group of participants that does not take part in the relaxation~     programs.~      This is an investigational study. The relaxation programs are being compared for research~     purposes only.~      An assessment is any time you complete a set of scheduled activities for this study, such~     as tests and questionnaires.~      Up to 700 patients will take part in this study. All will be enrolled at MD Anderson.~   "
180463|NCT01202838|"~     The purpose of this study is to study composites of bioactive glass and methylmetacrylate~     with glass fibre reinforcement in cranial bone defect reconstruction.~   "
180464|NCT01202825|"~     The purpose of this study is to assess the safety and tolerability of TMC647055 both after~     increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after~     multiple oral doses in fed conditions at increasing dose levels administered for 6 days, as~     well as to assess the pharmacokinetics of TMC647055 after increasing single oral doses from~     100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed~     conditions at increasing dose levels administered for 6 days and to assess the effect of food~     on a single oral dose of TMC647055 at one dose level, all in healthy participants. In~     addition, the safety, tolerability, pharmacokinetics and the antiviral activity of TMC647055~     will be determined after 6 days of consecutive dosing and of TMC647055 and TMC435 after 10~     days of co-administration in chronic hepatitis C virus infected patients. Pharmacokinetics~     means how the drug is absorbed into the bloodstream, distributed in the body and eliminated~     from the body. TMC647055 is being investigated for the treatment of chronic hepatitis C~     infection.~   "
180465|NCT01202812|"~     The purpose of the study is to determine the effectiveness of LOVAZA (fish oil capsules) to~     decrease inflammation in children and adolescents with Sickle Cell Disease (SCD). It has been~     found that besides the damage caused by sickle red blood cells themselves, the inflammatory~     response that occurs in SCD patients could potentially play a significant role in the~     occurrence of painful episodes or pain crises. The investigators will also study whether the~     subject/caregiver feels that there is an improvement in the child's quality of life by taking~     the medication. Besides the effect of LOVAZA on inflammation,the investigators are also~     testing whether the drug will have a beneficial effect on blood clotting ability (which is~     known to be increased in SCD) and on the anemia (low red blood cells) that is part of the~     disease entity.~   "
180466|NCT01202799|"~     It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac~     administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject~     convenience and compliance with a comparable bioavailability, safety and tolerability profile~     to that of the approved PENNSAID solution administered four times a day (QID).~   "
180467|NCT01202786|"~     The aim of the study is in cancer of unknown primary (CUP) patients, to compare the~     cost-effectiveness of miRview™ mets test with conventional work-up in identifying the primary~     tumor site.~   "
180468|NCT01202773|"~     The primary purpose of this study is to help answer if LY2127399 is safe and effective in the~     treatment of rheumatoid arthritis in participants with an inadequate response to one or more~     tumor necrosis factor-alpha (TNF-α) inhibitors.~      This study is comprised of 2 periods:~      Period 1: 24-week blinded treatment~      Period 2: 48-week post-treatment follow-up~   "
180469|NCT01202760|"~     The primary purpose of this study is to help answer if LY2127399 is safe and effective in the~     treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic~     drug (DMARD) therapy.~      This study is comprised of 2 periods:~      Period 1 - 24-week blinded treatment~      Period 2 - 48-week post-treatment follow-up~   "
180470|NCT01202747|"~     The objective is to evaluate the feasibility of using additional screening methods to~     optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure~     therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian~     gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and~     chalazia. The screening methods include diagnostic expression of the meibomian glands and~     interferometry assessment of the tear film.~   "
180471|NCT01202734|"~     The purpose of the study is to evaluate the pharmacokinetics and safety of 3 single doses of~     Methylphenidate HCl in healthy Japanese adult male volunteers.~   "
180472|NCT01202721|"~     The purpose of this study is to determine whether long-term treatment with a beta-blocker~     (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan, given~     to adult patients with bicuspid aortic valve (BAV) disease (aortopathy) reduces the widening~     (dilatation) of the aorta from its baseline size.~   "
180473|NCT01202708|"~     This study is designed to assess the safety, efficacy and dialytic capabilities of~     hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in~     comparison to conventional hemodialysis.~   "
180474|NCT01202695|"~     Primary:~      • To compare the safety profile of a single intravenous administration of AVP-21D9 as~     compared with Placebo~      Secondary:~        -  To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9~        -  To evaluate the immunogenicity of AVP-21D9~   "
180475|NCT01202682|"~     The purpose of this study is to gather ECG data during normal activity, exercise, and sleep~     from normal subjects with or without well-controlled epilepsy. This normal subject data will~     serve as true negative (i.e., no seizure occurring) challenge data for testing cardiac~     based seizure detection algorithms.~   "
180476|NCT01202669|"~     The purpose of this study is to collect continuous observational data during a clinical~     Epilepsy Monitoring Unit evaluation.~   "
180477|NCT01202656|"~     This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen)~     can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary~     data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine~     infusion of G-CSF can improve endometrial development and can increase implantation rates of~     embryos.~   "
181993|NCT01182662|"~     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells~     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for~     the therapy of severe aplastic anemia (SAA).~   "
180478|NCT01202643|"~     The purpose of this study is to investigate the effect of G-CSF on endometrial thickness in~     women who have failed reaching minimal endometrial thickness by standard treatments, to~     assess how many reach embryo transfer and what implantation and pregnancy rates are in~     comparison to control patients. The study will be conducted in women undergoing transfer of~     previously cryopreserved embryos or undergoing transfer of embryos from donor eggs.~   "
180479|NCT01202630|"~     The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for~     prevention of recurrent Clostridium difficile infection.~   "
180480|NCT01202617|"~     The purpose of the study is to determine whether the Seroquel XR treatment for 6 months~     improves the relapse prevention in schizophrenic outpatients~   "
180481|NCT01202604|"~     The primary objective of the study is to evaluate the efficacy of administered maintenance~     treatments in bipolar disorder I and II, defined as the percentage of patients who experience~     a relapse episode during the first 9 months after a mood event (manic or depressive).~   "
180482|NCT01202591|"~     The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination~     with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy~     (FISH4/5) or gene amplification (FISH 6)~   "
180483|NCT01202578|"~     The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube~     Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.~   "
180484|NCT01202565|"~     There is clearly a need for further data on the efficacy of biologic agents in the treatment~     of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports~     can be found, but no published data exists from non-interventional studies, such as~     post-marketing observational studies (PMOS) that reflect routine clinical practice.~      The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the~     treatment of nail and scalp psoriatic lesions in routine dermatologic practice.~   "
180485|NCT01202552|"~     One-site dose sparing intradermal influenza vaccination in elderly had been studied but~     resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity~     of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms~     of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram~     HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza~     vaccine administered intramuscularly at the standard dose is used as the reference vaccine.~   "
180486|NCT01202539|"~     The purpose of this study is to assess the ability of a modified thermoplastic mask system in~     keeping an individual head stationary for a predefined amount of time. The investigators hope~     to know if the modified mask is study enough, and also if the modification on the mask will~     allow the investigator see and track the individual's movement underneath the mask by means~     of a camera that can detect light reflected from the individual. Participants will lay down~     on their backs and their heads will be held in place with the mask system for approximately 1~     hour.~   "
180487|NCT01202526|"~     Gastric bypass surgery induces remission of diabetes within days after surgery, before~     significant weight loss. The aim of the study is to examine whether improved insulin~     sensitivity of muscle and liver contributes to the immediate diabetes resolution.~   "
180488|NCT01202513|"~     Vitiligo is an acquired depigmentation disorder of great cosmetic importance, affecting 1-4%~     of the world's population. Phototherapy and topical agents such as corticosteroids,~     calcineurin inhibitors, and vitamin-D derivatives are basic treatment modalities have been~     used in vitiligo but there is still no effective and safe treatment for this disease.~     Resistance to therapy, treatment complications and recurrence after treatment are the major~     problems of the current treatments.~      There are no clinical studies of use of Bimatoprost in treatment of vitiligo, as it is~     supposed to cause more hyperpigmentation and hypertrichosis as compared to other topical~     prostaglandin analogues; hence, the investigators decided to use it in treatment of localized~     vitiligo.~   "
180489|NCT01202500|"~     Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of~     contamination during pregnancy: the parasite can pass through the placental barrier and~     infect the foetus. The severity of congenital infection varies, but in France, where maternal~     seroconversions during pregnancy are treated, the manifestations of the disease are often~     infraclinical at birth and only appear during the first years of life in the form of~     retinochoroiditis. In order to prevent long-term sequellae, children with confirmed~     congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either~     sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has~     not yet been evaluated. Moreover, there is no consensus about the duration of the treatment,~     which varies, in France, from 12 to 24 months depending on the centre. Compared with the~     duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these~     treatments are very long. They are also far longer than the 3 months of treatment, which is~     in accordance with the World Health Organization (WHO) recommendations, given in Denmark to~     infants identified as being infected with the parasite during neonatal screening. A one-year~     treatment was developed in the United States, but it mainly concerns only symptomatic~     children, given the absence of generalised screening in the United States of America (USA).~     We have no arguments to justify the use of treatments lasting one year or more in children~     with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which~     may be severe, notably with regard to haematological or skin conditions, they have to be~     supervised closely with biological tests, which adds further constraints for both the~     children and their parents and increases the cost to health care systems.~   "
180490|NCT01202487|"~     Minor lacerations are a commonly treated injury in the paediatric emergency department . Over~     the past decade, standard closure of these lacerations has evolved from suture repair to~     closure with tissue adhesive (also referred to as skin glue). Local anaesthetic is not~     routinely used during application of skin glue as it was with sutures. There are, however,~     several potential advantages to pre-treating wounds with topical LET~     (Lidocaine-Epinephrine-Tetracaine), a liquid gel with anaesthetic and vasoconstrictive~     properties. Some believe LET can improve patient comfort, increase the ease of glue~     application, and lead to better healing when used on lacerations being repaired with tissue~     adhesive. This study aims to address the question of whether or not pre-treatment with LET~     improves outcomes in minor lacerations repaired with skin glue. The primary hypothesis is~     that pre-treatment of minor lacerations with LET will decrease pain (as measured on a Visual~     Analog Scale) during repair with tissue adhesive.~   "
180491|NCT01202474|"~     Primary Objective:~      Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level < 8% (in~     patients of 6-12 years old) and HbA1c level < 7.5% (in patients of 13-17 year old) at 6 and~     12 months of treatment~      Secondary Objectives:~      Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per~     patient from the baseline to the end of the study Change in daily dose of glargine and~     glulisine at 6 and 12 months of treatment.~   "
180494|NCT01202435|"~     The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a~     pregabalin controlled release tablet as compared to multiple doses of the pregabalin~     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin~     controlled release tablet as compared to multiple doses of pregabalin immediate release~     capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin~     controlled release tablet as compared to multiple doses of the pregabalin immediate release~     capsule.~   "
180495|NCT01202422|"~     The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate~     release capsule and 3) evaluate the safety and tolerability of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule.~   "
180496|NCT01202409|"~     The goal of this clinical research study is to learn if panitumumab can help to control~     advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be~     studied.~   "
180497|NCT01202396|"~     Pouchitis is a common complication following proctocolectomy with ileal pouch anal~     anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life~     and can become a chronic problem. The aetiology of pouchitis is not completely understood. A~     crucial role of the intestinal microbiota has been suggested, but no causative agent has been~     identified so far. Furthermore, the defensin expression and the epithelial integrity are~     altered in inflammatory bowel diseases and may play an important role in the development of~     intestinal inflammation. Therefore, it has been hypothesized that the interaction between an~     altered microbiota composition, a defective epithelial integrity and changes in innate~     defense parameters such as defensins has a pivotal role in the development of pouchitis in UC~     patients.~   "
180498|NCT01202383|"~     The proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to~     determine if the impact of treating water with chlorine at the household level is effective~     in preventing diarrhea among young children. For more than a century, chlorine has be used to~     treat water in municipal systems in developed countries. Lack of infrastructure has prevented~     its use in lower-income settings. NaDCC is a tablet form of chlorine that has been used for~     more than 30 years in emergencies and has recently been approved for routine treatment of~     drinking water by the WHO and US Environmental Protection Agency. The placebo will consist of~     the food-grade ingredients in the effective tablet, without the chlorine. Study participants~     will be supplied with tablets (intervention or placebo) and instructed to use the same to~     treat their water daily. Monthly follow-up visits will assess diarrhoea morbidity and~     weight-for-age Z scores in <5s. Chlorine residual and bacteriological quality of water stored~     in the home will be measured each month. The study will also assess the impact of the~     intervention on absenteeism from school and work and on health care expenditure for~     diarrhoea.~   "
180499|NCT01202370|"~     Camptothecins are a potent class of anticancer drugs that inhibit DNA Topoisomerase I. While~     seen strictly as cytotoxic compounds, camptothecins are actually also targeted agents,~     inhibiting DNA-Topoisomerase I (Topo I) cleavable complex. First and second generation~     cogeners are hampered by a labile α-hydroxy-δ-lactone pharmacophore, which hydrolyzes to~     yield the inactive carboxylate form of the drug. AR-67~     (7-t-butyldimethylsilyl-10-hydroxycamptothecin) is a third generation analog engineered to be~     stable in blood and highly potent. Its enhanced stability results from two factors: (1) AR-67~     is highly lipophilic, partitioning into lipid bilayers, thus protecting it from hydrolysis in~     the aqueous milieu of the bloodstream, and (2) the 10-hydroxy functionality of the drug~     effectively ablates the high affinity interactions of the carboxylate drug form with albumin,~     which has been previously shown to diminish the levels of the active lactone species in the~     circulation. In a recently completed phase I trial, AR-67 showed over 85% lactone stability~     at all time points studied, and was well-tolerated with grade 4 thrombocytopenia, neutropenic~     fever and grade 3 fatigue as dose limiting toxicities. The MTD was established at 7.5~     mg/m2/day in a daily times five of a 21 day cycle. Preclinical data indicates that AR-67 may~     concentrate in tumors for a prolonged period of time, compared to plasma clearance of the~     drug, a phenomenon which has the potential to improve efficacy and decrease toxicity of this~     compound. What is not known is the optimal dose and schedule of AR-67 needed to produce high~     tumor penetration, and modest systemic exposure. This pilot proposal seeks to study AR-67 in~     a novel dosing schedule and to evaluate the feasibility of performing tumor biopsies to~     determine the tumor half-life of AR-67 in humans. By using multiple tumor biopsies, as a~     means to document penetration of tumor tissue by AR-67, and compare that to plasma clearance~     of the drug, the investigators will establish direct pharmacokinetic evidence that AR-67~     hits the target. The investigators propose that a rigorous evaluation of drug penetration~     into the tumor should be considered, in addition to the MTD, when determining dose of new~     experimental compounds. Dose-tumor concentration relationships should be established early in~     the course of clinical development to provide data for rational selection of the phase-II~     dose. This pilot study will provide important preliminary data to establish the feasibility~     of this approach for future study. If successful, tumor half life will be used to develop an~     optimal biologic dose in a phase I trial using this schedule of AR-67. Optimal biologic~     dosing could become a new standard for dose escalation studies with this compound and other~     cytotoxic drugs that have specific biologic targets in the future.~   "
180500|NCT01202357|"~     A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case~     management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an~     additional year of case management, or (2) terminating case management for the next 12~     months. The current study aims to investigate whether an additional year of case management~     in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms,~     quality of life and health economics.~   "
180501|NCT01202344|"~     The purpose of this study is to develop a computer program that might be able to accurately~     assess the risk of artery re-narrowing following angioplasty or stenting based on computer~     images. After angioplasty (a procedure to re-open narrowed or blocked blood vessels) the~     patients will have extra images taken in order to assess the results of the procedure; which~     will then be used to see whether or not these images can help predict outcomes such as the~     patient having to come back to the hospital to have the procedure done again.~   "
180502|NCT01202331|"~     Mass antimicrobial administrations have been remarkably successful in reducing the prevalence~     of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively~     lower the prevalence of infection, and in some cases may even result in local elimination.~     Mass treatments cannot be continued forever, due to concerns about cost and antibiotic~     resistance. The hope has been that other measures such as latrine construction and hygiene~     programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has~     yet demonstrated an effect on infection.~        1. We hypothesize that Chlamydial infection will return to communities when treatment ends.~        2. We hypothesize that infection will be completely eliminated in all communities treated~          for seven years.~        3. We hypothesize that identifying and treating clinically active cases among preschool~          aged children will delay or even prevent reemergence at a far lower cost than mass~          treatment of all individuals.~   "
180503|NCT01202318|"~     This study will compare the diagnostic accuracy of Card 28 stroke protocol to Card 28 and~     Cincinnati Stroke Scale, when used by emergency medical dispatchers to interrogate a 911 call~     suggestive of stroke.~      The authors hypothesize that a combination of Card 28 plus the Cincinnati Stroke Scale (CSS)~     will improve the diagnostic accuracy of emergency medical dispatchers for stroke.~   "
180504|NCT01202305|"~     HIV medicines have led to dramatic improvements in health. However, there remains a concern~     for potential drug toxicities, cost of drugs, and need for life-long treatment. In addition,~     research has found that health is not completely restored in HIV-infected patients, even if~     they have been taking effective HIV medicines for a long time. This may be due to direct~     drug-toxicity, continued replication of the virus, and/or inflammation of the body in~     response to the virus. Therefore, a more complete understanding of how HIV stays in the body~     is necessary.~      Recent research has shown that one of the places that HIV can stay in the body is in~     lymphatic tissues such as lymph nodes (even in patients who have been taking HIV medicines~     for a long time). In addition, the amount of damage to the lymphatic tissues can predict how~     the immune system (CD4+ T cell count) will respond to therapy.~      The investigators therefore propose a study in which lymph nodes from the groin area will be~     removed, with the goals of: 1) seeing how much HIV is in lymph nodes and 2) seeing how much~     damage has happened to the lymph node architecture.~   "
180505|NCT01202292|"~     The overall goal of IMOAP study is to assess whether the efficacy of the healthcare~     professionals' usual practices, together with a motivational group intervention (delivered by~     a nurse trained by an expert psychologist), is more effective than an isolated traditional~     intervention on weight loss and its maintenance in overweight and obese patients.~     Furthermore, the study will evaluate whether this result has a positive impact on quality of~     life, changes in eating habits, and a reduction in the associated cardiovascular risk factors~     and overall cardiovascular risk.~   "
180506|NCT01202279|"~     The purpose of this study is to determine if treatment with Mucinex D lowers the use of~     antibiotics in the treatment of upper respiratory infection when compared to placebo~   "
180507|NCT01202266|"~     The primary purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers~   "
180508|NCT01202253|"~     The purpose of this study is to describe the real world effectiveness of anidulafungin in~     clinical practice in a large Liver Unit in the United Kingdom.~   "
180509|NCT01202240|"~     Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on~     the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and~     eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy~     volunteers.~   "
180510|NCT01202227|"~     The purpose of this study is to assess the safety of the long-term use of pregabalin at doses~     up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain,~     post stroke pain, and multiple sclerosis pain).~   "
180511|NCT01202214|"~     The purpose of this study is to describe the safety and tolerability of single and repeat~     oral doses of GSK1440115 in healthy volunteers.~   "
180512|NCT01202201|"~     The purpose of this study is to evaluate the epidemiology and baseline disease burden of~     rotavirus gastroenteritis in children < 6 years of age, in Japan.~   "
180513|NCT01202188|"~     The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in~     patients with moderate to severe COPD.~   "
180514|NCT01202175|"~     The investigators aim to evaluate subjects at high risk of future development of~     hypertension, those with a family history of hypertension and/or that already have high~     normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. The investigators plan to~     investigate whether these subjects have the same markers (such as microscopic protein in the~     urine or C-reactive protein in the blood) in the blood and urine that people with high blood~     pressure have, and whether they are improved before and after taking the beta-blocker~     nebivolol.~   "
180515|NCT01202162|"~     Goals for ambulatory surgery include providing optimal surgical conditions while ensuring a~     rapid early recovery without side effect. Dexter et al1 concluded in a meta-analysis that~     Desflurane can reduce the extubation time when compared to Sevoflurane. This potential~     benefit of Desflurane can be especially attractive in short ambulatory cases performed with~     general anesthesia with a laryngeal mask airway.~      Although some studies have not shown a difference on perioperative cough and laryngospasm~     between Desflurane and Sevoflurane at clinically relevant doses.It has been reported in the~     literature that Desflurane causes cough4 and many providers avoid using Desflurane with a LMA~     (laryngeal mask airway) in the ambulatory setting. In this study we will also evaluate, as a~     secondary outcome, the presence and severity of perioperative cough and laryngospasm.~      Previous investigators have demonstrated a more rapid resumption of normal daily activities~     after ambulatory surgery in patients anesthetized with Desflurane when compared with~     Sevoflurane.these investigators suggested a better quality of recovery when Desflurane is~     used probably due to a lower lipid solubility of Desflurane. We will also evaluate quality of~     recovery as a secondary outcome using a validated instrument.~      Significance:~        1. A more rapid awakening, especially, in a fast and high turnover cases that are performed~          with LMA can lead to a more cost effective utilization of operating room time~        2. It has been reported that Desflurane causes more cough than Sevoflurane and~          Anesthesiologists avoid using Desflurane with LMA cases, this study will reinforce that~          there is no difference.~   "
180516|NCT01202149|"~     This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic~     dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream~     1% and Hylatopic™ Plus Emollient Foam™ in subjects with atopic dermatitis. Subjects will~     apply Elidel® (pimecrolimus) cream 1% twice daily for four weeks on a chosen target~     eczematous area located on one side of the body and then apply Hylatopic™ Plus Emollient~     Foam™ three times daily on a symmetrical target eczematous area on the opposite side of the~     body. A randomized list will be created to determine which side the subject applies each~     medication.~      Subjects will be consented prior to any study evaluations or procedures. After signing the~     consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will~     apply study medication (Elidel® and Hylatopic™ Plus Emollient Foam™) to chosen affected areas~     for four weeks. Photography will be used to record the location of target lesions at the~     baseline, week two and week four/final visits. Subject's disease status will be assessed by~     two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom Score (TLSS)~     (see sections V.B.2 and V.B.3). PGA as well as TLSS will be made at baseline (Day 0), week~     two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for each of the~     target lesions. Half scales (i.e. 0.5, 1.5) will not be used. The presence or absence of skin~     atrophy and telangiectasias will be noted at each study visit as well.~      Additionally, subjects' self-assessments of their perception of degree of disease and itching~     severity control will be collected at each visit for each target lesion. This assessment will~     be made using a four point scale and Itch Severity Scale (visual analogue score) respectively~     (see section V.B.4). Lastly, subjects will take a Product Preference Survey at week 4/final~     visit (Day 28 +/- 2days). Parents (or guardians) will moderate Product Preference Surveys for~     subjects that are younger than 12 years of age.~   "
180517|NCT01202136|"~     The aim is to propose and prospectively validate a diagnostic approach and model for~     prediction of mucinous versus non-mucinous, and malignant versus non-malignant pancreatic~     cysts using a combination of clinical, radiologic, and biomarker characteristics.~   "
180518|NCT01202123|"~     The purpose of this study is to evaluate the safety and efficacy of highly purified (HP)~     menotrophine to Korean women.~   "
180519|NCT01202110|"~     The primary objective of this study is to determine in patients with traumatic brain injury~     (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia~     (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or~     decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive~     to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the~     number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to~     treatment that occur without propranolol.~   "
180520|NCT01202097|"~     The primary objective will be to compare the formulations regarding their impact on the~     pulmonary function of persistent asthma patients and the secondary objective will be the~     clinical control of the disease's symptoms.~   "
180524|NCT01202045|"~     The purpose of this study is to assess the value in terms of sensitivity, specificity and~     likelihood ratio of the stress echocardiography in the screening of pulmonary arterial~     hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial~     hypertension.~   "
180525|NCT01202032|"~     This is an open-label, multicenter dose-escalation phase I study using a 3+3+3 design (i.e.,~     3 to 9 patients per dose level) in patients with mRCC or others advanced refractory solid~     tumors. Enrolment will be performed to include approximately ½ of patients with mRCC.~      The primary endpoint is the occurrence of limiting toxicities leading to definitive~     discontinuation of the study drugs during the first 24 weeks in absence of progression of the~     disease.~      Secondary endpoints included the occurrence of Dose Limiting Toxicities (DLTs) evaluated~     during the first two cycles; overall response rate, 6-months progression-free survival rate~     and Pharmacokinetic assessments.~   "
180526|NCT01202019|"~     This study is designed to assess the impact of exercise and supplementation on measures of~     fitness, function, and cardiovascular disease risk factors/modifiers in individuals with~     spinal cord injury (SCI). The primary purpose of this study is to improve fitness and~     function, reduce cardiovascular disease risks, and enhance oxidation of dietary and body fats~     in persons with chronic tetraplegia through acute exercise, exercise conditioning, and~     dietary supplementation. This study will test the hypothesis that timing of supplementation~     with regards to exercise bout ('intervention/placebo') affects fitness, function, lipid~     profiles, lipid oxidation, and inflammatory markers after acute exercise and chronic~     conditioning.~   "
180527|NCT01202006|"~     The purpose of this study is to determine whether a structured diagnostic-therapeutic~     strategy to detect and treat previously unrecognized (or unestablished) heart failure in~     primary care will improve the functional capacity, quality of care, the quality of life, and~     eventually the prognosis of these patients.~   "
180528|NCT01201993|"~     The investigators hypothesis is that a significant number of patients may remain without~     specific cause and have recurrent syncope with its associated physical and mental morbidity.~   "
180529|NCT01201980|"~     This study is aimed to evaluate response rate of the antihypertensive treatment with a~     calcium antagonist in real life practice, to evaluate patients' quality of life and to~     collect the following Serbia-specific epidemiology data on hypertension: demographic data,~     patents characteristics, and patients' management/treatment.~   "
180530|NCT01201967|"~     For this trial, the investigators propose a prospective trial of a collaborative care program~     to identify and treat depression, generalized anxiety disorder, and panic disorder among~     patients admitted to the hospital for an acute cardiac illness (acute coronary syndrome,~     congestive heart failure, or arrhythmia). Such assessment and treatment for~     depression/generalized anxiety disorder/panic disorder will begin in the hospital, and~     ongoing management will continue for six months following discharge.~      The investigators hypothesize that this model will lead to increased treatment rates,~     improved mood, reduced anxiety, and improved medical outcomes in this vulnerable population.~     If this model is effective, it could be implemented clinically to provide better and more~     complete care to patients hospitalized with acute cardiac illness, for whom depression and~     anxiety may be a risk factor for complications and death.~      This will be a two-arm, single-blind randomized controlled trial, with one-half of patients~     randomized to collaborative care and one-half randomized to the control condition (usual~     care). Psychiatric treatment in the intervention arm will be provided in concert with~     patients' primary care physicians—with primary care physicians prescribing all~     medications—within a framework supervised by a psychiatrist.~      The investigators will enroll patients who have any (or all) of the three included~     psychiatric diagnoses to improve the utility of the intervention. The investigators have~     chosen to enroll patients with several different cardiac diagnoses. This will allow the~     researchers to include patients with heterogeneous diagnoses and illness severity to~     determine if our intervention is effective in a broad population of patients with heart~     disease. The investigators will study an intervention targeting depression, generalized~     anxiety disorder, and panic disorder: all three disorders are disabling and associated with~     adverse cardiovascular outcomes, treatments for the conditions are highly similar, the~     investigators can treat patients who have more than one disorder, and a prior outpatient~     program successfully simultaneously addressed more than one mental health condition.~      The project will involve: (1) screening patients for depression, generalized anxiety~     disorder, and panic disorder as part of usual clinical care, (2) evaluation of~     positive-screen patients by a study social work care manager, (3) a multicomponent~     in-hospital intervention (for collaborative care patients) that involves patient education,~     specialist-provided treatment recommendations, and a goal of in-hospital treatment~     initiation, and (4), after discharge, continued phone-based evaluation and care coordination~     with primary care physicians to provide stepwise treatment in the collaborative care arm. The~     intervention has been designed to be low-cost, low-burden, and easily generalizable to other~     settings.~   "
180531|NCT01201954|"~     Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of~     preterm infants during endotracheal suctioning.~   "
180532|NCT01201941|"~     The objective of this study is to compare the effects of a web-based laboratory information~     system (e-Chasqui) between a network of health establishments with access to e-Chasqui~     (intervention group) and a network of health establishments without access to e-Chasqui~     (control group).~      The specific aims are:~        1. To compare the laboratory turn-around-time (from the date a culture or drug~          susceptibility test (DST) result is obtained to the date the result is obtained at the~          health center) of samples pertaining to health establishments in the intervention versus~          the control group.~        2. To compare the clinical turn-around-time (from the date the DST result is obtained to~          the date the patient is evaluated by a physician in possession of that result) among~          multi-drug-resistant tuberculosis (MDR-TB) patients pertaining to health establishments~          in the intervention versus control group.~        3. To compare the laboratory reporting errors (defined as incorrect smear, culture, or DST~          results) between health establishments in the intervention versus control group.~        4. To qualitatively assess the acceptability and usability of e-Chasqui among users in~          health establishments with access to the system.~      The investigators aim to test the following hypotheses:~        1. The laboratory turn-around-time for health establishments with e-Chasqui access will be~          smaller than that for establishments without e-Chasqui access.~        2. The clinical turn-around-time for patients pertaining to health establishments with~          e-Chasqui access will be smaller than that for patients in establishments without~          e-Chasqui access.~        3. Health establishments with e-Chasqui access will have fewer errors compared to those~          without e-Chasqui access.~        4. Factors associated with acceptability and usability of e-Chasqui by systems users can be~          identified.~   "
180533|NCT01201928|"~     The purpose of this study is to evaluate pulmonary function test (PFT) sub-study in~     interested subjects from studies MKC-TI-161, MKC-TI-162 and MKC-TI-166. 100 Type I and 100~     Type II diabetics will be enrolled. Each subject will undergo 6 PFT assessments over the~     course of the parent study.~   "
180534|NCT01201915|"~     This was a 3-cohort, open-label study of vismodegib (GDC-0449) in new (non-recurrent)~     operable basal cell carcinoma of the nodular subtype.~   "
180535|NCT01201902|"~     The purpose of this study is to assess the safety and the body's immune response to an~     experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will~     enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or~     vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than~     or equal to 65 years of age.~   "
180536|NCT01201876|"~     The purpose of this study was to document the reasons for replacement or repair of defective~     restorations (fillings) and to record the restorative material of the failed restoration~     and the material used in the replacement restoration on permanent (adult) teeth.~   "
180567|NCT01201473|"~     The purpose of this study was to study the use of a Core Questionnaire that included several~     questions from each PBRN (DPBRN, PEARL, PRECEDENT - collectively know as CONDOR) that had~     been extracted from questionnaires previously administered as part of their initial research~     program activities. This protocol was the first administration of this core questionnaire~     with the purpose of assessing dental practice changes that may have occured since the earlier~     administration of the individual questions with the separate networks.It also collected~     baseline data for others.~   "
180537|NCT01201863|"~     The purpose of this study is to: Address 3 short term objectives; (1) Determine the effects~     of physiologic testosterone (T) therapy on neurological function and functional independence~     following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation;~     (2) Document the natural history of neuroendocrine dysfunction and recovery in men during~     inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel~     assessment of neurological function for use in the TBI population; and two long-term~     objectives: (1) Utilize study findings to design a multicenter trial to further assess the~     impact of T therapy in hypogonadal men following TBI and (2) Impact TBI practice management~     with new information about neuroendocrine dysfunction after TBI and hormone treatments to~     improve outcomes.~   "
180538|NCT01201850|"~     This study is being done to learn about the safety of the study drug bevacizumab(Avastin®),~     when used to treat radiation necrosis.~      The primary objective of this study is to test the feasibility of treating Central Nervous~     System (CNS) tumor patients suffering from radiation necrosis with bevacizumab every 2 weeks.~      The secondary objectives of this study are:~        -  To evaluate improvement in neurologic symptoms associated with bevacizumab as assessed~          by clinical evaluation;~        -  To investigate the neuro-imaging changes in radiation necrosis associated edema,~          including Mass Resonance (MR) spectroscopy;~        -  To evaluate changes in corticosteroid use in patients with radiation necrosis following~          treatment with bevacizumab;~        -  To evaluate changes in quality of life.~   "
180539|NCT01201837|"~     Cardiovascular disease remains the most pressing healthcare issue for developed countries and~     is becoming so for developing countries. There are a number of chronic therapies available~     for long-term management of risk. Short term therapies for subjects with an acute event, such~     as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing~     thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a~     different site. There are no approved therapies that can rapidly reduce the burden of~     unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that~     could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities~     of cholesterol from the vasculature, improvement in endothelial function, protection against~     oxidative damage and reduction in inflammation. This study will assess the effects of~     CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and~     regression as assessed by intravascular ultrasound (IVUS) measurements in patients with~     (ACS).~   "
180540|NCT01201824|"~     Pulmonary nodules are one of the most common thoracic radiographic abnormalities. They are~     usually found accidentally as discrete well emarginated pulmonary lesions found within the~     lung parenchyma during a routine chest x-ray. Pulmonary nodules are usually asymptomatic.~     Most solitary lung nodules are benign; however these nodules can represent early stage lung~     cancer. The identification of malignant pulmonary nodules is important because they represent~     a potential form of curable lung malignancy. Every lung nodule should therefore be~     investigated for the possibility of malignancy.~      Ultrasound has been beneficial in almost all medical and surgical specialities. The idea of~     using ultrasound during VATS has emerged from its use in laparoscopic procedures. Few studies~     have investigated the use intracavitary ultrasound for localizing pulmonary nodules. The~     sensitivity of ultrasound detecting pulmonary nodules is high (92%). In some studies,~     ultrasound could detect all pulmonary nodules detected by high resolution CT. It has also~     been shown to be able to locate nodules not visualized on spiral CT.~      The use of intracavitary ultrasound has been suggested by many authors as a safe and~     effective method for localizing hard to find nodules. It is a real time technique with no~     associated complications, low cost, and has the potential to save operative time. Most~     importantly, it may be able to prevent conversion of VATS to open operations in cases where~     nodules are not visualizable or locatable using VATS techniques.~      The use of intracavitary US as a localization method by surgeons intra-operatively could lead~     to better identification of nodules. Also, this technique could avoid performing multiple~     procedures on patients (CT guided targeting followed by surgery) and therefore is more~     cost-efficient. If proven accurate, surgeon-performed intracavitary ultrasound could be used~     routinely during VATS procedures, increasing the chances of finding and localizing pulmonary~     nodules using minimally invasive techniques.~   "
180541|NCT01201811|"~     The primary purpose of this study is to determine the effectiveness and safety of azacitidine~     in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).~   "
180542|NCT01201798|"~     The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times~     daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of~     endogenous anterior uveitis.~   "
180543|NCT01201785|"~     Since diabetic platelets are characterized by an enhanced turnover rate, it may be~     hypothesized that an increase in the frequency, rather than the dose, of drug administration~     may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this~     may enable COX-1 blockade of newly generated platelets. However, how different dosing~     regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has~     been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate~     how increasing the frequency of aspirin administration, remaining within the daily~     recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with~     coronary artery disease.~   "
180544|NCT01201772|"~     A higher degree of platelet inhibition remains the goal of peri-interventional and long-term~     anti-thrombotic therapy in patients with coronary artery disease. In clinical practice,~     patients undergoing percutaneous coronary intervention with stent implantation who are~     already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior~     observations showing that higher inhibition of platelet aggregation may be achieved by giving~     a loading dose of clopidogrel in patients with coronary artery disease while on chronic~     clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet~     aggregation can be achieved by adding a prasugrel loading dose in patients on chronic~     prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel~     re-load strategy in patients on already on chronic prasugrel therapy will be useful.~   "
180545|NCT01201759|"~     The overall study objectives are to examine whether:~        1. Persons with spinal cord injury (SCI) having elevated body mass are at greater~          cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and~          vascular inflammation than persons with SCI having 'normal' body mass, and~        2. An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks~          associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.~   "
180568|NCT01201460|"~     The principal goal of this study was to assess the feasibility of plasma glucose testing in~     private dental practice. A second aim was was to assess prevalence of plasma glucose~     abnormalities in dental patients seen by (DPBRN) practitioner-investigators.~   "
181994|NCT01182649|"~     Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in~     all comers PCI eligible patients~   "
180546|NCT01201746|"~     Currently the research issue in establishing the role of periodontal disease (PD) in coronary~     heart disease (CHD) risk is to define the pathways that lead to cause-effect relationship~     between PD and CHD. There is no consensus on definition of a periodontal disease case or the~     threshold level that may give clear indication for this relationship. Periodontal therapy has~     been used in different studies with the hope that a change in periodontal disease status may~     modify the factors associated with CHD risk. Many of these studies, on role of periodontal~     therapy in the reduction of CHD associated risk-factors, were based on small study samples,~     and very few studies were randomized controlled trials. So a need for large prospective~     studies is warranted in literature.----------- A single-blind parallel-arm randomized~     controlled clinical trial was designed to observe the influence of periodontal treatment on~     serum inflammatory mediators of hsC-reactive protein, white blood cells and fibrinogen in CHD~     patients.~      Hypothesis: Periodontal therapy in CHD patients, by reducing periodontal inflammation, may~     decrease the host systemic inflammatory burden associated with atherogenic processes.~   "
180547|NCT01201733|"~     The purpose of this study is to evaluate the immediate effect of traditional Thai massage on~     brain electrical activity in the patients with scapulocostal syndrome~   "
180548|NCT01201720|"~     The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on~     albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic~     patients with acute-on-chronic liver failure.~   "
180549|NCT01201707|"~     The study is being done to determine if venous angioplasty is an effective treatment for~     chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or~     blockages are present in the internal jugular or azygos veins (veins which drain blood from~     the central nervous system) and these blockages may be associated with symptoms classically~     attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with~     CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the~     effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two~     groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty~     and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in~     this study, and the neurologist evaluating patients after the procedure, will not know~     whether or not they were treated with angioplasty.~   "
180550|NCT01201694|"~     The goal of this clinical research study is to find the highest tolerable doses of~     surface-controlled water dispersible curcumin (curcumin) that can be given to patients with~     advanced cancer. The safety of this drug will also be studied.~   "
180551|NCT01201681|"~     The purpose of this study is to identify pre-operative factors that put patients at greater~     risk of developing severe tooth pain following root canal therapy, thereby providing evidence~     that will allow dentists to act preventively to lessen this risk, improve pain control,~     increase their patients' quality of life, and decrease the number of dental emergency~     interactions.~      A parallel goal of this study is to assess the feasibility of recruiting dentists that~     provide root canal therapy and patients using the DPBRN.~   "
180552|NCT01201668|"~     The purpose of this study is to document by survey the occurence of tooth pain present 3~     months and 6 months after root canal therapy in the patients recruited for the DPBRN~     Peri-operative tooth pain study. This study will access the feasibility of obtaining 3~     month and 6 month follow-up data on the patient enrolled in the DPBRN Peri-operative tooth~     pain study.~   "
180553|NCT01201655|"~     The purpose of this study is to investigate the impact of splenectomy coupled with~     portal-azygous disconnection on hepatocarcinogenesis in patients with post-hepatitic~     cirrhosis after hepatitis B or C virus infection by retrospective case-control study,We hope~     to find a new idear and method to prevent or cure HCC.~   "
180554|NCT01201642|"~     The aim of this study is to compare the effects of prednisolone and staging acupuncture in~     the recovery of the affected facial nerve, and to verify that whether in combination with~     staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large~     number of patients.~   "
180555|NCT01201629|"~     Overall goal of this study is to determine if transcranial direct current stimulation (tDCS)~     plus conventional occupational therapy improves functional motor recovery in the affected~     arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional~     occupational therapy, and to obtain information to plan a large randomized controlled trial.~   "
180556|NCT01201616|"~     A previous study has found that the consumption of a high fat, low carbohydrate meal results~     in increased feelings of calmness, friendliness and an increase in subjective energy levels~     in comparison to a low fat, high carbohydrate meal. The purpose of this study is to~     investigate whether a high fat, low carbohydrate diet for a longer duration (of 2 weeks) can~     enhance or sustain these changes in comparison to a low fat, high carbohydrate meal.~   "
180557|NCT01201603|"~     The aim of this study is primarily to investigate the ability of antioxidants found in orange~     juice (OJ) to increase the body's sensitivity to the hormone insulin. Overweight or mildly~     obese women, who are otherwise healthy, will be recruited. The time commitment for subjects~     is ~14wks. Subjects will attend the laboratory on 5 occasions after fasting from midnight.~     The 1st is a medical screening. Laboratory visits 2 & 5 will take ~5hrs and will be separated~     by 3 months, during which time subjects will consume 250ml of an orange drink (either OJ or~     an orange flavoured control drink) once a day. During visits 2 & 5, subjects will have a scan~     to assess their %body fat using a low-dose x-ray machine, and have their insulin sensitivity~     measured using a technique called a 'Glucose Clamp'. During the 3hr glucose clamp, subjects~     receive an infusion of the hormone insulin and a glucose solution directly into their blood~     stream, with insulin sensitivity determined from the amount of glucose required to maintain~     blood glucose at normal levels. In addition, a small sample of fat tissue (about the size of~     a haricot bean) will be taken from underneath the skin of the belly. Subjects will record~     their food intake for 3-days in weeks 3, 7 and 11 of consuming the drink, and come to the lab~     for visits 3&4 during weeks 4&8. Laboratory visits 3&4 repeat measurements taken in the 1st~     (screening) visit.~   "
180569|NCT01201447|"~     The purpose of this study was to investigate the process involved when making decisions about~     the diagnosis and treatment of questionable lesions, as well as determine if there is any~     association between lesions progression (or depth, if opened) and clinical characteristics~     and baseline risk assessment.~   "
180558|NCT01201590|"~     The aim of the current study is to investigate the ability of antioxidants found in cocoa~     ('flavanols') to increase the body's sensitivity to the hormone insulin. 32 overweight or~     mildly obese women, who are otherwise healthy, will be recruited. Subjects will attend the~     laboratory on 3 occasions after fasting from midnight. The 1st visit is a medical screening,~     with laboratory visits 2 and 3 separated by 4 weeks, during which time subjects will consume~     a cocoa drink (containing either high or low amounts of flavanols) twice a day. Subjects will~     record their food intake for 3-days before visit 2 and in week 3 of consuming the cocoa. They~     will also eat a diet of standard macronutrient composition for 3 days before visits 2 and 3.~     During the 5 hour laboratory visits, subjects will have a scan to assess their body~     composition using a low-dose x-ray machine (Dual Energy X-ray Absorptiometry; DEXA), and have~     their insulin sensitivity measured using a 3 hour hyperinsulinemic, euglycaemic Clamp.~   "
180559|NCT01201577|"~     It has recently been discovered that bacteria are able to communicate using specialised~     molecules known as Quorum Sensing Signalling Molecules (QSSMs). An accumulation of QSSMs in~     their surrounding environment allow for the bacteria to quantify the size of colonies. At~     specific colony sizes the concentration of QSSMs reaches a critical threshold leading to the~     activation of genes that cause an infection. It is by this mechanism that bacteria within a~     colony coordinate behaviour to activate infectivity when colony sizes are large enough to~     withstand defensive measures from the host's immune system. A disruption of quorum sensing~     may reduce the severity of infection and this has led to the development of inhibitors of~     quorum sensing as a new strategy in antibacterial therapy.~      QSSMs are also thought to facilitate infection by other mechanisms and are able to influence~     the number and function of a specific type of immune cell known as an 'antigen presenting~     cell'. These cells are pivotal in allowing the immune system to recognise components of~     bacteria as foreign and thereby mount the appropriate response. It was found that large~     numbers of these types of cells underwent programmed cell death (cell suicide) in the~     presence of QSSMs compared to when QSSMs were absent. This mirrors the situation in blood~     sampled from patients with severe infections where there is a greater proportion of cell~     deaths among antigen presenting cells than other types of immune cell.~      This study aims to establish in healthy volunteers, the mechanisms by which QSSMs affect~     immune cells and facilitate the spread of infection. Antibiotic administration in humans can~     alter the environment of the intestine and can lead to an overgrowth of harmful bacteria to~     potentially cause an infection. Probiotics supplements can prevent bacterial overgrowth and~     potentially reduce infective complications. The mechanism, which we aim to clarify, may~     involve changes in both the production of QSSMs and the function of immune cells.~      Hypothesis~        1. Antibiotic use alters gut flora, leading to the appearance in the systemic circulation~          of bacterial QSSMs and changes in immune function of the host.~        2. Probiotics and/or prebiotics have beneficial effects by preserving the normal resident~          gut flora, thereby, modulating bacterial QSSMs and preserving the immune function of the~          host.~      Aims~      The aims of our study are 2 fold:~        1. Firstly, to study the effect of orally administered antibiotic on QSSMs (in faeces and~          blood) and on innate and adaptive immunity in healthy humans.~        2. Secondly, to study the effect of orally administered combinations of prebiotic,~          probiotic and antibiotic on QSSMs (in faeces and blood) and on innate and adaptive~          immunity in healthy humans.~   "
180560|NCT01201564|"~     This study is designed to compare two techniques for operative care of umbilical hernia in~     adults regarding wound complications, wound side fluid collections, recurrence rate,~     postoperative pain, duration of hospitalization and quality of life. The IPOM technique~     provides mesh positioning directly into the abdominal cavity onto the defect under~     laparoscopic control while in sublay position the mesh is placed directly behind the rectus~     muscle after small incision close to the belly button.~   "
180561|NCT01201551|"~     It is already known that the local treatment with Alphagan eye drops (a drug commonly used by~     glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the~     vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a~     prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this~     effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD).~     To test for the effect of these drugs on PVD and non-PVD subjects the investigators will take~     measurements of corneal temperature as surrogate for ocular blood flow.~   "
180562|NCT01201538|"~     Acoustic Neuromas (otherwise known as Vestibular Schwannoma -VS) are benign tumors which grow~     on the hearing nerve and can cause progressive hearing loss and compression of vital brain~     structures and even death if it continues. The primary objective of this study is to evaluate~     the efficacy of Nilotinib in the treatment of patients with progressing VS. Secondary~     objectives of this study is to evaluate the toxicity profile, quality of life and symptom~     management of Nilotinib in the treatment of patients with progressing VS.~   "
180563|NCT01201525|"~     Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser~     treatments.~      Study design: Prospective single blinded within patient controlled randomised trial. Recent~     surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be~     treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will~     serve as a within patient control. 1 and 6 months after the intervention both parts of the~     scar will be evaluated.~   "
180564|NCT01201512|"~     The purpose of study was to characterize using an online questionnaire the feasibility of~     recruiting dentists in primary care dental practices in the practice-based research network~     and documenting their current initial care for their TMJD pain patients.~   "
180565|NCT01201499|"~     Inadequate pain control after abdominal procedures may lead to adverse postoperative outcome.~     Epidural analgesia is currently an accepted technique in abdominal surgery, but its use has~     been limited in liver resections by postoperative coagulation disturbances and the possible~     increased risk of bleeding complications, including spinal hematoma. A range of alternative~     analgesic techniques can be used for major liver or pancreatic resections, including~     intrathecal morphine (single shot) administered immediately before surgery, and continuous~     administration of intravenous (IV) short-acting opioids, such as remifentanil, plus a single~     bolus of IV morphine. Postoperatively analgesia may be obtained by patient-controlled~     morphine analgesia (IV PCA). Both protocols have been demonstrated to provide satisfactory~     postoperative pain relief, and each has its unique advantages. However, to this end there is~     no data in the literature to show benefit from one regimen over the other. We therefore wish~     to determine whether there is a difference in analgesic efficacy between the two techniques,~     as optimizing perioperative pain relief in this rapidly expanding surgical field is of utmost~     importance. Our hypothesis is that continuous intraoperative IV analgesia with remifentanil~     followed by IV PCA morphine is not inferior to intrathecal morphine with respect to analgesia~     and ambulation outcome, and may provide an alternative, non-invasive intraoperative analgesic~     technique.~   "
180566|NCT01201486|"~     To evaluate the percentage of severe heart defect diagnosed with the use of color Doppler at~     a routine fetal scan in the second trimester of pregnancy~   "
180583|NCT01201265|"~     This multicenter study will assess the efficacy and safety of bevacizumab in combination with~     gemcitabine and cisplatin as first line treatment in participants with triple negative~     metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg~     intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an~     area under curve [AUC]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study~     treatment is until disease progression.~   "
180570|NCT01201434|"~     Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic~     treatment. These factors taken together with high sputum viscosity and slow motility of the~     gastrointestinal tract-may change the pathogenicity and consistency of the intestinal~     pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A~     pilot study performed by the researchers using probiotics in CF patients showed a decrease in~     the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled~     trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum~     inflammatory markers in CF patients.~   "
180571|NCT01201421|"~     The purpose of this study was to administer two questionnaires. The first, a Dental~     Satisfaction Questionnaire to assess patient satisfaction with a restoration visit using~     patients recruited from practices participating in the Dental PBRN Reasons for replacement~     or repair of dental restorations study. The second questionnaire (completed by the~     practitioner) was a brief single page questionnaire to evaluate the patient visit.~   "
180572|NCT01201408|"~     The purpose of this study is to assess the quality and expected lifespan of fillings recorded~     in the DPBRN Reasons for placing the first restoration on permanent tooth surfaces study,~     and the factors affecting how long the fillings last.~   "
180573|NCT01201395|"~     The purpose of this study is to assess the quality and expected lifespan of fillings recorded~     in the DPBRN Reasons for replacement and repair of dental restorations study, and the~     factors affecting how long the fillings last.~   "
180574|NCT01201382|"~     This study is a randomized controlled trial comparing Interpersonal Psychotherapy-Adolescent~     Skills Training (IPT-AST) to group counseling (GC) for the prevention of depression in~     adolescents. The project will: (1) identify adolescents with elevated depressive symptoms but~     who do not meet criteria for a current mood disorder diagnosis; (2) randomize eligible~     adolescents to either IPT-AST (N = 100) or GC (N = 100); (3) assess depressive symptoms,~     depressive disorders, global functioning, interpersonal functioning, comorbid conditions and~     school related indices at baseline, mid-intervention, post-intervention, and at 6-, 12-, 18-,~     and 24-month follow-up; (4) examine the effects of IPT-AST on depression and various domains~     of functioning at each time point; and (5) conduct analyses to examine potential mediators~     and moderators of the association between IPT-AST and depression outcomes. This study will~     yield data on the efficacy of IPT-AST relative to GC for the prevention of depressive~     symptoms and depressive disorders. It will also provide information about the mechanisms of~     action of IPT-AST and determine for whom IPT-AST is most effective.~   "
180575|NCT01201369|"~     Despite recent advances in stent technology and clot reducing drug therapy, acute stent~     occlusion or thrombosis (ST), still occurs and can be life threatening. It has been shown~     that certain features of how the stent relates to the artery wall may predict ST. One such~     feature, so-called stent strut malapposition (SSM), can be assessed after implantation but~     current imaging techniques are relatively unreliable. Optical Coherence Tomography (OCT) is a~     newer technology that can be performed safely and easily after angioplasty and may allow the~     stent struts to be assessed more accurately and reliably.~      This study will use OCT to examine how two different types of commonly used drug-eluting~     stents relate to the artery wall. The Xience V (Abbott Vascular, USA) stent has thinner~     struts and a more open frame than the Cypher (Cordis, USA) stent. We hypothesise therefore~     that the potentially more pliable structure of the Xience V stent will be associated with~     greater contact with the vessel wall. This may have a bearing on the relative rate of SSM,~     although large studies have shown the rate to be low in both the Cypher and the Xience V~     stent. We believe that OCT imaging of SSM and symmetry of the stent immediately after~     angioplasty will compliment conventional visual assessment and may identify those patients in~     whom further improvement of stent with a balloon is necessary.~      This study will involve the random allocation of forty patients requiring coronary~     angioplasty to one of the Cypher or Xience V stent. The procedure will be performed in the~     usual manner as indicated clinically and will include imaging of the stented artery segment~     with OCT once the operator is satisfied with the visual result by angiography.~   "
180576|NCT01201356|"~     The purpose of this study is to collect long-term safety and tolerability, long-term~     efficacy, and health outcome data in all patients currently ongoing in the fingolimod~     multiple sclerosis clinical development program. This study will combine all currently~     ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned~     studies into one single long-term extension protocol that will provide patients with~     continuous treatment and will continue until fingolimod is registered, commercially~     available, and reimbursed in the respective countries.~   "
180577|NCT01201343|"~     This study is planned to evaluate emotional disorders during treatment by interferon (IFN)~     beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label~     exploratory study with no change of therapeutic behavior but with standardized~     neuropsychologic follow-up.~   "
180578|NCT01201330|"~     The purpose of this study was to determine the prevalence of ONJ in the patient population of~     2 large HMOs and study the risk factors associated with the development of this condition.~   "
180579|NCT01201317|"~     A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days~     treatment in patients with painful diabetic polyneuropathy.~   "
180580|NCT01201304|"~     This study compares the relative efficacy of three methods of delivering interoceptive~     exposure for the reduction of elevated anxiety sensitivity. The interventions vary according~     to their intensity and use of coping strategies during exposure. An expressive writing~     intervention serves as an expectancy control.~   "
180581|NCT01201291|"~     Aim of the study is to investigate the impact of two different fractions of inspired oxygen~     (FiO2) on outcome in patients with severe traumatic brain injury (TBI).~   "
180582|NCT01201278|"~     This study is designed to compare the safety and tolerability of two different doses of~     intranasally administered regular human insulin with those of a single dose of the~     rapid-acting insulin analog lispro Humalog® after subcutaneous injection. In addition to~     safety and tolerability, various pharmacokinetic (PK) and pharmacodynamic (PD) parameters~     will be evaluated by means of the euglycemic glucose clamp technique.~   "
180650|NCT01200394|"~     PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791~     will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure,~     improving renal function.~   "
180584|NCT01201252|"~     The purpose of this study is to estimate the disease burden and epidemiology of rotavirus~     gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute~     gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book~     and stool samples will be collected from all suspected and confirmed acute gastroenteritis~     cases.~   "
180585|NCT01201239|"~     To assess the safety, tolerability and efficacy of Raltegravir (RAL) when combined with other~     antiretroviral drugs in treatment-experienced Chinese HIV-infected patients, including those~     with multi-drug resistant HIV-1 infection or drug intolerance.~   "
180586|NCT01201226|"~     The purpose of this study to obtain ovarian cortical fragments from perimenopausal patients,~     who undergo pelvic organ surgery and test whether treatment with PTEN inhibitor and PI3K~     activating peptide would induce these fragments to produce FSH responsive follicles in the~     nude mouse model.~   "
180587|NCT01201213|"~     A need exists to define the best local anesthetic and technique for pain relief in early~     labour. We suggest that calculating the molar Median Effective Dose for bupivacaine,~     levobupivacaine and ropivacaine given both by the intrathecal (as a combined spinal epidural~     and epidural routes) would provide a valid comparison between the pain relieving properties~     of all three drugs, from which a reasoned assessment of side effects can be made.~   "
180588|NCT01201200|"~     The purpose of this study is to determine whether patients with obstructive sleep apnea have~     any changes in right ventricular function evaluated by three dimensional echocardiography.~   "
180589|NCT01201187|"~     This study will evaluate clinical efficacy and safety of treatment with YY-162 in children~     with ADHD~   "
180590|NCT01201174|"~     In the present study the investigators are going to explore the oxidative status of HS-RBC~     and its contribution to hemolysis~   "
180591|NCT01201161|"~     The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative~     vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving~     its anatomical and functional results in patients with advanced proliferative diabetic~     retinopathy and traction retinal detachment.~   "
180592|NCT01201148|"~     This study will investigate whether using oscillating TES (random noise stimulation) or~     intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to~     standard tDCS.~   "
180593|NCT01201135|"~     Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and~     sideroblastic anemia were found to express very high levels of serum GDF15, and this~     contributed to the inappropriate suppression of hepcidin with subsequent secondary iron~     overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in~     patients with Sickle cell disease and hereditary spherocytosis~   "
180594|NCT01201122|"~     The purpose of this study is to evaluate effectiveness of once daily dosing of Pentasa~     compared with twice daily in children with mild to moderate active ulcerative colitis.~   "
180595|NCT01201109|"~     The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel~     release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after~     surgery.~   "
180596|NCT01201096|"~     The purpose of this study is to show the tumor free long term survival of patients with~     isolated non-resectable liver metastases of neuroendocrine tumors after neo-adjuvant radio~     receptor treatment and following liver transplantation.~   "
180597|NCT01201083|"~     Specific Aim 1: Identify drug use patterns and partnership dynamics that mediate risk~     behaviors over time in a cohort of recently HIV infected men and their partners.~      Specific Aim 2: Determine predictors of transmission risk within partnerships of recently HIV~     infected men and their partners, using the partnership as the unit of analysis.~      Specific Aim 3: Quantify the long-term population-level impacts of voluntary behavior change~     by men with recent HIV infection, through the use of dynamic mathematical modeling that~     integrates our data on behavior change with current estimates of temporal infectiousness~     patterns. The investigators will also determine whether more frequent testing and/or~     development of tests with earlier sensitivity may have a significant impact on the epidemic.~     Finally, the magnitude of this effect to that obtained by decreasing drug use or risky sexual~     behavior prior to or following seroconversion will be compared. This will be conducted as a~     statistical analysis by co-investigators at the University of Washington.~   "
180598|NCT01201070|"~     General and specific objectives of the search: evaluate the effects of the administration of~     Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis,~     platelet function, inflammatory response and markers of organ damage in patients undergoing~     cardiac surgery by cardiopulmonary bypass (CPB) with low plasma levels of post-operative~     Antithrombin (AT).~   "
180599|NCT01201057|"~     The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of~     bacterial vaginosis.~   "
180600|NCT01201044|"~     The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced~     NSCLC.~   "
180601|NCT01201031|"~     Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial~     pathogen of health-care associated infection since 1988. Although the new antimicrobial~     agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the~     treatment of VRE, but there was not appropriate drugs for eradicating the colonization of~     VRE. So the active surveillance and strict contact precaution are the best methods for VRE~     colonization and transmission.~      This is a one year study program, we select a unit as the study site. First month (January)~     is the prepare period. Therefore , we collect 3 months (from February to April) baseline~     data, then interrupted one month(May) for the health care worker's infection control~     education.~      Then the intervention period are three months (from June to August), and the last four~     months(from September to December) are the analysis and evaluation period. In the baseline~     period, we only do the patient's active surveillance and environmental culture. In the~     intervention period, beside the patient's active surveillance and environmental culture, we~     add contact precaution as the infection control method. If patient has VRE infection, we~     prescribe appropriate antibiotic therapy until the culture result proved no growth of VRE.~      The aim of this study is to compare and analyze these two period (baseline period and~     intervention period) for understanding the transmission, risk factors and carriage rate of~     VRE, as the important guidelines for the VRE infection control in the future.~   "
180602|NCT01201018|"~     The study will be non randomized, open label, dose rising study in cancer patients. Cancer~     treatment is consisting of 2 different drugs: Oshadi D and Oshadi R that will be administered~     orally.~      The study will include two sessions:~        -  A single dose period to evaluate acute toxicity of each drug~        -  Consecutive multiple increment dose escalation period of both drugs to determine the~          long-term safety, and the anticancer activity.~   "
180603|NCT01201005|"~     Premature birth and low birth weight implies insufficient intrauterine growth and fetal~     malnutrition. During the first months of life where the infant is breastfed, the low stores~     aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants~     with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months~     infants with biochemical signs of impaired cobalamin status (i.e.: tHcy > 97.5 percentile for~     cobalamin treated infants, i.e.: tHcy>6.5 µM/L) will be randomised to cobalamin treatment or~     placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo~     treatment according to infant biochemical status and neurodevelopment.~      Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency~     will normalize biochemical status and cause improved motor neurodevelopment.~   "
180604|NCT01200992|"~     This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be~     conducted in approximately 120 investigational sites worldwide. Subjects with either~     recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for~     participation in this study.~      Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1,~     and/or CIS) at least 6 months from the start of a full induction course of BCG with or~     without maintenance/re-treatment at 3 months.~      Recurrent disease is defined as reappearance of disease after achieving a tumor-free status~     by 6 months following a full induction course of BCG with or without maintenance/re-treatment~     at 3 months. Subjects with recurrent disease must have recurred within 18 months following~     the last dose of BCG.~      Approximately 450 subjects will be randomized. The primary objective of this study is to~     evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment of~     subjects with recurrent or refractory NMIBC. The secondary objective is to evaluate the~     safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent~     or refractory NMIBC. This study will consist of 4 phases: Screening, Induction, Maintenance~     and Follow-Up and will be conducted over 3 years.~   "
180605|NCT01200979|"~     Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that~     would facilitate fetal tolerance and result in an increased susceptibility to infection.~     Although the suppression has been characterized as a global T-cell defect, the observation~     that the increase in susceptibility is restricted only to specific intracellular bacteria and~     viruses is consistent with a down regulation of only certain components of the innate immune~     system. Progress in the treatment and management of infections during pregnancy will require~     further understanding of the changes to the immune system that occur during pregnancy. It is~     hypothesized that there is a fundamental down-regulation in the innate immune system that~     occurs during pregnancy and remains until delivery and that changes in serum cytokines~     influence na(SqrRoot) ve CD4 differentiation to different subpopulations. To that end, this~     study will evaluate blood samples drawn from pregnant women during early, mid, and late~     pregnancy and post-partum for changes in the innate immune system and compare them to those~     of healthy, non-pregnant women. Changes in the cytokine profile and in the lymphocyte and~     natural killer (NK) cell populations will be identified. A comparison of any observed changes~     will be made with those previously reported for in vitro and in vivo studies.~   "
180606|NCT01200966|"~     Background:~      - Essential tremor (ET) is a neurological disorder involving uncontrollable shaking, which~     over time can interfere with mobility and affect routine aspects of daily living. Several~     medications are used to treat ET, but these medications are often only partially effective~     and can have side effects. About two-thirds (66%) of people with ET have some relief from~     drinking alcohol, which suggests that alcohol affects the part of the brain causing the~     tremor. However, more research is needed to better understand the effects of alcohol or what~     areas of the brain might be important in the response.~      Objectives:~        -  To study to what extent alcohol is reducing tremor in a group of patients with essential~          tremor.~        -  To use transcranial magnetic stimulation to study the effects of alcohol on essential~          tremor.~      Eligibility:~      - Individuals who are at least 21 years of age, have been diagnosed with essential tremor and~     have tremor in both hands, and can tolerate being off all medications for essential tremor~     for up to 4 weeks.~      Design:~        -  This study has one screening visit (1 to 2 hours), followed by one study visit (3 to 5~          hours). Participants might be asked to also take part in one additional study visit (3~          to 5 hours). The maximum period between the study visits is 3 months.~        -  Participants will be screened with a medical history, physical examination, and blood~          tests. At this visit, participants will receive information about how to safely taper~          off their current ET medications before the start of the study.~        -  Participants must be willing to abstain from drinking any alcohol or caffeine (or~          consuming foods with caffeine such as chocolate) for at least 2 days before the study~          visits. Participants must also fast overnight (for at least 8 hours) before the study~          visits.~        -  At the first study visit, participants will receive a single drink of alcohol (mixed~          with a noncaffeinated drink) and will complete movement tests to determine whether the~          alcohol improves the tremor. Alcohol levels will be monitored throughout the visit.~        -  At the second study visit, participants will have an electrocardiogram to measure heart~          electrical activity and determine if they are able to safely have transcranial magnetic~          stimulation. Participants will then receive an intravenous infusion of alcohol and~          complete questionnaires during the infusion to provide information about its effects.~          Then, transcranial magnetic stimulation will be used to study brain electrical activity,~          as well as muscle movements and tremor activity, while under the influence of the~          alcohol infusion.~        -  After each study visit, participants will remain at the clinical center until the~          effects of the alcohol have worn off. Participants will be able to resume taking their~          ET medications after the end of the study.~   "
180607|NCT01200953|"~     Background:~      - Increased clinical attention has been paid to the evaluation and management of~     bioterrorism-related illness (such as anthrax infection) and emerging infectious diseases~     (such as Severe Acute Respiratory Syndrome [SARS] and new strains of influenza). However,~     evaluation and treatment data for these illnesses are often limited because human infections~     to date have been relatively limited. Further knowledge about diseases of bioterrorism~     concern and emerging infectious diseases may lead to more effective forms of therapy to~     prevent disease-related illnesses and deaths.~      Objectives:~      - To apply standardized, documented, and carefully monitored evaluation and treatment methods~     for bioterrorism- and biodefense-related illnesses and emerging infectious diseases at the~     National Institutes of Health Clinical Center.~      Eligibility:~        -  Individuals at least 2 years of age who have confirmed or suspected infection by a~          biodefense or bioterrorism agent, or an emerging infectious disease agent.~        -  Individuals at least 2 years of age who have confirmed or suspected exposure to a~          biodefense or bioterrorism agent, an emerging infectious disease agent, or who have~          close exposure to an individual who is suspected of being infected with one of these~          agents.~        -  Health care workers who are involved in medical treatment of the abovementioned infected~          or exposed individuals.~      Design:~        -  All eligible persons will have an initial screening evaluation to determine the~          circumstances of possible infectious exposure (e.g., where, when, and how exposed),~          current medical condition and medical care given, and any aspects of medical history~          that might be relevant to the exposure.~        -  Participants may be seen in an outpatient clinic or in the Special Clinical Studies Unit~          (SCSU) at the National Institutes of Health (NIH). The NIH SCSU is a hospital ward~          specially designed to minimize the risk of spreading infection to others.~        -  Upon admission, participants will provide blood and urine samples, have an~          electrocardiogram to measure heart activity, and have specific tests or procedures~          associated with the particular infectious agent.~        -  Participants who develop illnesses will be treated with the standard of care for known~          diseases or with experimental measures, depending on the nature of the illness. Separate~          consent may be required for these treatments.~        -  Participants will remain on this study for at least 1 year following the period of~          active evaluation and treatment. Participants may be asked to come to the NIH outpatient~          clinic on a periodic basis for medical evaluations and blood tests, and may be asked to~          keep a diary card to record any unusual signs or symptoms of possible infection.~   "
180608|NCT01200940|"~     Background:~      - Artificial sweeteners, such as sucralose (brand name Splenda), are very commonly found in~     products such as diet soft drinks. Recently, researchers learned that these sweeteners may~     affect hormones in the body, especially when they are consumed in combination with real~     sugar. Changes in hormone levels may, in turn, result in changes in blood sugar, appetite,~     and weight. Researchers are interested in studying the effects of artificial sweeteners on~     the metabolism and hormonal levels of healthy volunteers.~      Objectives:~        -  To study the effects that artificial sweeteners have on hormone levels, blood sugar, and~          appetite.~        -  To evaluate whether artificial sweeteners change the rate at which food passes out of~          the stomach into the gut, or the rate at which the body absorbs sugar from the gut.~        -  To evaluate the effects that different amounts of artificial sweeteners have on hormone~          levels.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age.~      Design:~        -  This study will require one screening visit and four testing visits, scheduled on~          different days.~        -  At the screening visit, eligible participants will be screened with a physical~          examination, medical history, blood samples, and body measurements (including height,~          weight, body circumferences, and skin folds). Participants will also be asked about how~          much artificial sweetener they typically consume and will have taste tests, in which a~          small amount of flavored liquid is placed on the tongue and participants will name the~          flavor and rate its intensity.~        -  Participants will have four glucose tolerance tests on four different days. In~          preparation for the test, participants will not eat or drink anything but water for 12~          hours prior to the test. Blood will be drawn before the test, and participants will~          drink one of the following study liquids, selected at random:~        -  Plain water~        -  Water mixed with sucralose (the amount found in one 12 oz diet soft drink)~        -  Water mixed with sucralose (the amount found in 2.5 12 oz diet soft drinks)~        -  Water mixed with sucralose (the amount found in 3.7 12 oz diet soft drinks)~        -  Ten minutes after drinking the study liquid, participants will have a sugary drink that~          will allow researchers to measure sugar absorption and the speed with which food leaves~          the stomach.~        -  In addition, participants will complete questionnaires about hunger levels before~          drinking the sugar solution and at regular intervals for 2 hours afterward. Blood~          samples will be taken at regular intervals as well.~   "
180609|NCT01200927|"~     The overall goal of this research is to understand the mechanisms underlying the development~     of postural control in sitting using new methodology, in order to provide a scientific basis~     for evaluation and treatment of posture and movement disorders in infants with cerebral~     palsy. The development of early posture control remains poorly understood despite~     considerable therapeutic effort. Infants with cerebral palsy show their first delays in the~     acquisition of sitting, with subsequent problems developing adequate posture and movement~     control. Identifying the delay, determining the nature of the problem, and evaluating the~     effectiveness of treatment quickly, are vital in the early part of an infant's life, since~     this is the time of greatest plasticity. Tools from nonlinear dynamics, which are~     increasingly being used to examine other biological rhythms, are used in this study to~     analyze postural sway from center of pressure data during the development of sitting postural~     control.~   "
180610|NCT01200914|"~     Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two~     areas of particular problems are the terminal portion of the cephalic vein near the shoulder~     and the central veins in the chest. Although angioplasty is standard of care the treated~     narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your~     dialysis access functional. Recently there has been introduction of a new technology called a~     covered stent graft. Initial studies suggest that placing this device across the area of~     narrowing leads to dialysis access staying open longer and needing less angioplasty~     treatments.~      This study is designed to compare angioplasty (standard of care) versus using a covered stent~     graft. The investigators will then look at the dialysis records and future fistulograms to~     see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial~     procedure.~   "
180611|NCT01200901|"~     In summary, the investigators propose to integrate fMRI assessments within a clinical trial~     of quetiapine XR in patients with melancholic depression in order to test the predictions~     that:~        1. quetiapine XR treatment will be effective and safe for patients with major depression~          with melancholic features~        2. successful treatment with quetiapine XR will be associated with normalization of limbic~          areas associated with increased salivary cortisol response to a stressful task as well~          as normalization on the emotional faces task differences in the melancholic group~          compared with healthy volunteers.~        3. successful treatment with quetiapine XR will be associated with normalization of the~          salivary cortisol response to the stressful math task (i.e. there will be a diminished~          post-treatment mean AUC for cortisol secretion after the stress task compared to the~          pre-treatment AUC values in the patient group)~   "
180612|NCT01200888|"~     The objective of the study is to implement a new method of performing chest CT imaging in~     young children with cystic fibrosis at Packard Children's Hospital. This technique will be~     used to evaluate early lung disease comparing quantitative chest CT air trapping and airway~     measurements with lung function measurements in infants, toddlers, and young children with~     chronic lung disease.~   "
180613|NCT01200875|"~     Platelet-Rich Plasma (PRP) has been banned in competitive athletes because some people think~     it may enhance athletic performance. However, there is very little published research to~     support or undermine this point of view. The purposes of this study are: (1) To assess the~     effects of local platelet-rich plasma (PRP) therapy on systemic levels of growth factors with~     suspected or known performance-enhancing effects; and (2) To understand whether the effect of~     PRP therapy on these growth factors differs between intramuscular and intratendinous PRP~     injections.~      This research study is looking for 40 people who are receiving platelet-rich plasma therapy~     for a tendon or muscle injury. The study involves collecting seven blood samples (2 teaspoons~     each) from each patient, before and after the PRP treatment. Blood samples may be donated at~     any location of the patient's choosing, and participants will be paid for their time.~   "
180614|NCT01200862|"~     This study is designed as a 2-part study, with Part 1 being open-label to best determine the~     appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo~     controlled design. The study aims to assess the safety and tolerability of BGS649, and~     determine whether or not BGS649 is able to normalize testosterone levels and improve insulin~     sensitivity in obese, hypogonadotropic hypogonadal (OHH) men~   "
180615|NCT01200849|"~     The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx~     container label design to improve Spanish speaking patients' understanding of instructions~     for use.~   "
180651|NCT01200381|"~     It's the aim of this study to analyze the benefit of personal patient / physician contacts in~     heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or~     ICD with cardiac resynchronization therapy (CRT-D).~      The personal follow up (in clinic or phone calls) will be compared to completely automatic~     remote follow ups.~      All patients will receive remote monitoring for automatic daily alarm checks and will undergo~     in clinic follow ups in 12 months intervals~   "
180735|NCT01199276|"~     The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD),~     diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip~     fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four~     days post-surgery.~   "
180616|NCT01200836|"~     Background:~      - The drug rosuvastatin (also called Crestor) is used to lower cholesterol levels in people~     with elevated cholesterol levels. Recent studies have suggested that rosuvastatin may affect~     the immune system and reduce inflammation, but the reason for this effect is unclear.~     Researchers are interested in testing the effect of rosuvastatin on the immune systems of~     healthy volunteers with good cholesterol levels.~      Objectives:~      - To evaluate the effect of rosuvastatin on the immune systems of healthy volunteers.~      Eligibility:~      - Healthy individuals at least 18 years of age who have an acceptable blood level of LDL~     cholesterol (below 160).~      Design:~        -  Participants will be screened with a medical history and physical examination, as well~          as blood tests to check general health, cholesterol levels, liver function, and the~          C-reactive protein (which responds to inflammation).~        -  Participants will not be permitted to take most prescription and over-the-counter~          medications that affect the immune system, including antihistamines and certain pain~          relievers. For 1 week before the study, participants will have a wash-out period without~          any of these medications.~        -  Participants will take rosuvastatin daily for 4 weeks, always in the evening (to ensure~          consistent blood sample results).~        -  Participants will provide blood samples at the following time points: (1) immediately~          before the start of the rosuvastatin treatment, (2) after 2 weeks of treatment, (3)~          after 4 weeks of treatment, and (4) 2 weeks after the end of treatment.~   "
180617|NCT01200823|"~     Background:~      - The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) is~     conducting a variety of laboratory research experiments that require blood, bone marrow,~     urine, stool, and/or tissue samples from patients with a diagnosis of an immunologic,~     autoimmune, or inflammatory disorder, as well as from their healthy relatives. Donated~     samples will be sent to the CHI laboratory at the National Institutes of Health to be used in~     research that may provide more information on the changes in the immune system caused by~     these specific disorders.~      Objectives:~      - To collect blood, leukapheresis cells, bone marrow, urine, stool, cheek swab, and tissue~     samples from patients with immune-mediated and inflammatory diseases, as well as from family~     members, for ongoing exploratory research studies.~      Eligibility:~        -  Individuals at least 2 years of age who have been diagnosed with an immune-mediated or~          inflammatory disease, or have signs or symptoms of an immune or inflammatory disease~          without a formal diagnosis.~        -  Immediate family members (parent, child, sibling, grandchild) of the above mentioned~          individuals.~      Design:~        -  Participants will be screened with a complete medical history, physical examination, and~          blood and urine samples.~        -  Participants will provide blood, urine, stool, cheek swab, and tissue samples as~          required by the study researchers.~        -  Participants who have immune or inflammatory diseases will also provide blood and bone~          marrow samples collected through biopsies and leukapheresis (to collect specific blood~          cells).~        -  Adult relatives will provide additional samples through more invasive procedures such as~          leukapheresis and bone marrow biopsies. Child relatives (between 2 and 18 years of age)~          will not undergo these invasive procedures.~        -  No treatment will be provided as part of this protocol.~   "
180618|NCT01200810|"~     This partially randomized phase II trial is studying how well giving bicalutamide together~     with RO4929097 works in treating patients with previously treated prostate cancer. Androgens~     can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may~     lessen the amount of androgens made by the body. RO4929097 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Giving bicalutamide together with~     RO4929097 may be an effective treatment for prostate cancer~   "
180619|NCT01200797|"~     This phase II trial is studying how well SJG-126 works in treating patients with epithelial~     ovarian, primary peritoneal, or fallopian tube cancer that did not respond to previous~     treatment with cisplatin or carboplatin. Drugs used in chemotherapy, such as SJG-136, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing.~   "
180620|NCT01200784|"~     Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum~     phosphate levels of dialysis patients in a dose dependent manner.~   "
180621|NCT01200771|"~     Fever of unknown origin (FUO) and chronic inflammatory syndrome could be seen in many~     affections. The diagnostic process is still a challenge and could not be specified yet after~     several clinical studies performed by trained teams using two levels diagnostic procedures.~     For this reason, the diagnosis involves many additional and expensive tests such as computed~     tomography (CT scan), scintigraphic imaging, endoscopy, biopsy. There is no evidence-based~     recommendation for the diagnostic work-up of FUO or chronic inflammatory syndrome. Positron~     emission tomography with 2-[18F] fluoro-2-deoxy-D-glucose combined with CT scan (FDG-PET/CT)~     is widely used in malignant diseases and seems to be promising for the diagnosis of~     inflammatory disorders. Its role has not been yet clearly defined in the investigation of FUO~     and chronic inflammatory syndrome.~   "
180622|NCT01200758|"~     This two-stage, multi-center, randomized, controlled, open-label study will investigate the~     pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants~     with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized~     to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400~     milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy.~     Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will~     receive maintenance treatment for a further maximum number of 12 cycles. Maintenance~     treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was~     designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum~     Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3~     weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1.~     Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with~     rituximab IV. The anticipated time on study treatment is 96 weeks.~   "
180623|NCT01200745|"~     The purpose of this study is to determine whether topical capsaicin patch can effectively~     reduce chronic neck pain.~   "
180624|NCT01200732|"~     A preliminary observational study by the investigators has shown that tadalafil, a selective~     phosphodiesterase-5 inhibitor (PDE-5) decreases pulmonary vascular resistance(PVR) in~     patients of eisenmenger syndrome (ES) resulting in increase in pulmonary blood flow (Qp),~     systemic oxygen saturation (SaO2), functional class and exercise capacity. The aim of this~     placebo controlled trial was to assess the effect of the drug on exercise capacity and~     functional class compared to placebo.~   "
180625|NCT01200719|"~     To investigate the efficacy of using transcranial alternating current stimulation (tACS) to~     enhance the regaining of neurological function among post-stroke patients.~   "
180626|NCT01200706|"~     The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or~     three times a day to children with non-severe community-acquired pneumonia.~   "
182450|NCT01176695|"~     The purpose of the study is to compare a fish oil containing lipid emulsion against a~     medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and~     safety during postoperative parenteral nutrition.~   "
180627|NCT01200693|"~     BACKGROUND:~      Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The~     selection of the type of drug-eluting stents (DES) and the technique for stent implantation~     have not been clarified. The side-branch (SB) is emerging as critical point, accounting for~     more than a third of the significant restenosis in the DES era. A series of data supports the~     adoption of a conservative strategy: stenting the main vessel (MV) only and reserving a~     conservative approach on the SB. Yet, the clinical relevance in terms of inducible ischemia~     of sub-optimal angiographic result has not been clarified.~      AIMS OF THE STUDY:~      The aims of the present study are:~        1. to compare in a prospective study the acute 3D angiographic results and the late~          clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting (EES) vs Zotarolimus~          eluting stent (ZES) obtained using a provisional TAP-stenting technique.~        2. to prospectively assess the clinical relevance (inducible ischemia) of suboptimal~          angiographic result in the SB after stenting.~      METHODS TO BE APPLIED:~      75 consecutive patients with bifurcated lesions undergoing PCI with the provisional~     T-and-small-protruding (TAP) technique with ZES implantation will be enrolled. Procedural and~     post-PCI details will be prospectively recorded. The subgroup of patients in which complete~     revascularization has been achieved will enter a systematic assessment of inducible ischemia~     by early and late exercise tests.~      Off line 3D quantitative coronary angiography (QCA) assessment will be performed and used to~     divide the study population in 2 groups according to the SB residual stenosis:~        -  Group O (optimal SB angiographic result): post-PCI SB area stenosis<50%~        -  Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis>50%.~      For the comparison among SES and EES, data will be obtained from the randomized trial~     SEA-SIDE (NCT00697372).~      PRIMARY STUDY END-POINTS.~        1. COMPARISON BETWEEN ZES, SES AND EES:~           SB acute angiographic result; SB trouble; target bifurcation failure.~        2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization:~          inducible ischemia at the early exercise test or occurrence of early spontaneous~          ischemia related to the SB.~   "
180628|NCT01200680|"~     Background:~      Chordoma is a rare, slow growing, often fatal bone cancer derived from remnants of the~     embryonic notochord. It occurs mostly in the axial skeleton (skull base, vertebrae, sacrum~     and coccyx), is more frequent in males than females, and has a median age at diagnosis of~     58.5 years, with a wide age range. This typically sporadic tumor is often advanced at~     presentation, and mortality is high due to local recurrence or distant metastases. The usual~     treatment is surgery, followed by adjuvant radiation therapy. Chemotherapy has not had a~     significant treatment role. Reports of a small number of families worldwide with two or more~     relatives with chordoma support a role for susceptibility genes in chordoma etiology.~     Recently we determined that duplications of the T gene co-segregated with disease in four~     multiplex chordoma families. The T gene encodes brachyury, a tissue-specific transcription~     factor that is expressed in notochord cells and is essential for formation and maintenance of~     the notochord. Some of the other chordoma families that we studied did not have T-gene~     duplications; the aggregation of chordomas in these families may result from changes in other~     susceptibility genes or other types of mutations targeting the T gene. We are continuing gene~     identification studies of multiplex chordoma families at the NIH Clinical Center under~     protocol 78-C-0039. We also want to determine whether alterations in any identified chordoma~     susceptibility genes are associated with sporadic chordoma in the general population.~      Objectives:~      The major goal of this protocol is to identify sporadic chordoma patients willing to provide~     germline and tumor DNA for studies to determine the frequency of alterations in chordoma~     susceptibility genes. Our previous protocols with SEER and Massachusetts General Hospital to~     identify chordoma patients were limited to residents of specific geographic regions in the~     U.S. (2 states and 2 metropolitan areas) or to patients with pediatric skull base tumors.~     This protocol will enroll patients who more broadly represent the age, site and gender~     distributions of sporadic chordoma in the general U.S. population.~      Eligibility:~      Eligible patients are males and females in the U.S. with chordoma diagnosed at any age and at~     any primary site. Because we want to obtain saliva from all participants, eligibility is~     limited to patients who will be greater than or equal to age 6 years at the time of~     enrollment.~      Design:~      The study description and contacting information including an e-mail link to the study~     contact person will be posted on web sites of two chordoma support groups. We will mail study~     information to be given to patients to colleagues at major medical centers that treat~     chordoma.~      The components of the study will be carried out in subjects' homes using materials mailed to~     them. Up to 100 participants will: 1) complete a self-administered Personal and Family~     Medical History Questionnaire, 2) collect saliva using a saliva collection kit, and 3)~     provide permission to obtain medical/pathology records, and paraffin blocks or slides on each~     primary chordoma. Parents will serve as proxies for minor children.~      We will recontact patients who report chordoma in at least one blood relative. If we confirm~     the relative's chordoma diagnosis, we will invite the study subject and selected family~     members to participate in clinical and gene mapping studies under protocol 78-C-0039. We may~     also recontact study participants to tell them about any new studies on chordoma etiology.~     They can decide at that time whether they want to participate in them.~   "
180629|NCT01200667|"~     The application scenario is shown in the figure below: the user utilizes an ECG-based~     wireless sensor (WiBoC Chipset), and transmit those signals to a mobile-phone device that has~     an embedded expert system integrated. With the aid of 3G system, a remote healthcare~     monitoring center receives those uploaded signals and stores into the application server.~     According to the events from this server, the people on service responses to the emergency~     and takes the corresponding process.~   "
180630|NCT01200654|"~     Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones. It has a~     specific inhibitory activity against Gram positive bacteria, including methicillin-resistant~     Staphylococcus aureus (MRSA).~      Dosage of 600 mg discontinuous administration twice a day was about studies in safety~     volunteers. The intensive care units patients, with mechanical ventilation, and with severe~     sepsis, represent highly heterogeneous population responsible of hight variability in~     pharmacokinetics parameters (augmentation in total volume of distribution, modification in~     glomerular filtration) wich can lead to antibiotic inefficacy.~      In a first time, this study describe the pharmacokinetics of Linezolid in intensive care~     units patients with severe MRSA infection. The aim of this study is to define and validate a~     population pharmacokinetic model including the influence of patients' characteristic on the~     pharmacokinetics of Linezolid.~   "
180631|NCT01200641|"~     Principle goals of sedation for eye surgery are to provide patient comfort and to allow the~     patient to stay calm during both retrobulbar injection and surgery. Insufficient sedation may~     not prevent the patient from moving during retrobulbar injection, whereas very deep sedation~     may result in respiratory complications during surgery .The investigators compared the effect~     of melatonin and gabapentin on the hemodynamic parameters, sedation ,anxiety, and pain and~     satisfaction profile in cataract surgery. After approval by the Hospital Evaluation Committee~     of Scientific Studies for ethical purpose and written informed consent, ninety patients~     scheduled for cataract surgery by phacoemulsification were randomly allocated to three study~     groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or~     placebo(GroupP, n=30) 90 minutes before retrobulbar injection. . Hemodynamic parameters~     ,anxiety, sedation score , and pain during block and surgery, satisfaction of surgeon were~     assessed. . At the preoperative visit verbal pain score (VPS) of 10 (0 = no pain and 10 =~     worst pain imaginable) and verbal anxiety score (VAS) ranging from 0 to 10 (0= completely~     calm, 10 = the worst possible anxiety) were explained to patients. Then a 20 gauge cannula~     was inserted into one of the two hands. Patients were monitored with electrocardiogram,~     noninvasive measurement of blood pressure, and pulse oximetry (SPO2). Retrobulbar nerve block~     was performed by the same ophthalmic surgeon who was unaware of group allocation with 1.5 ml~     of solution that prepared by nurse( lidocaine 2%and 0.5 ml bupivacaine) via the percutaneous~     route with a 25 G, 38 mm Atkinson needle (John Weiss & Son Limited, Milton Keynes,England),~     at inferotemporal site. No patient received an additional facial nerve block. The~     investigators assessed the pain immediately after block and surgery. Anxiety score and pain~     score was recorded in each patient before premedication (T1), ninety minutes after~     premedication, on arrival in the operating room (T2), one minute after retrobulbar block~     placement (T3)during the operation period) (T4) and postoperatively before discharging the~     patient from the recovery room (T5) .At the end of surgery, the patients were asked about~     average level of their anxiety and pain during the operation period according to the VAS and~     VPS explained to them before premedication.`. The surgeon was also asked to verbally rate~     their level of satisfaction according to three degree scale as very bad, , moderate, good~     after the operation. The sedation level of patients during performance of block was assessed~     as Sedation scores were obtained on a 3 point scale with 0 =movements of the head, arms and~     trunk ,1 =slightly movement of arms,2=slightly change in face,3=complete calm. If sedation~     was inadequate, fentanyl could be given 0.5microgram/kg as needed.~   "
180632|NCT01200628|"~     Posttraumatic stress disorder (PTSD) is a serious and often chronic response to~     overwhelmingly stressful events as Road Traffic Accident. Moreover PTSD is associated with~     increased rates of medical morbidity, poor health-related quality of life, and functional~     impairment. PTSD is prevalent in primary care settings after road traffic accident, where~     approximately 25% of patients meet diagnostic criteria for the disorder. Despite the~     development of a number of efficacious behavioral and pharmacological treatments, only a~     minority of patients with PTSD receive mental health services. PTSD is frequently~     underrecognized and untreated in Emergency Department and Surgical Unit.~      Then, early diagnosis and prevention of PTSD might help to identify patients with PTSD high~     risk and lead them to benefit of personalized cares. Nevertheless it is not possible (neither~     useful) to provide psychological cares for each road traffic accident victim.~      This is the reason why we think that nurses can help to screen patients who need treatment~     for PTSD Hypothesis : Recognition of specific clinical or biological signs occurring during~     road traffic accident victim hospitalization in surgical unit could allow beginning specific~     treatment using consultation liaison psychiatry.~      Early treatment could allow decreasing incidence of psychotraumatic disorders, increasing~     surgical functional efficacy and improve convalescence programs. The use of a specific~     questionnaire could help to screen this disorder.~      We have created the DEPITAC scale : a short screening questionnaire with 10 items.~      This study will be evaluated DEPITAC's 10-item screen for posttraumatic stress disorder~     (PTSD) for use in surgical or emergency department.~   "
180633|NCT01200615|"~     In this study we invetigate the influence of the nocebo effect (as part of obtaining informed~     consent) on the prevalence of side-effects. The study is prospective, focusing on the~     connection between what the physicians says to the patient about side-effects to the~     frequency of these side effects during treatment period. We also inquire whether informing~     the patient about the existence of the nocebo effect influences the extent of phenomena.~   "
180634|NCT01200602|"~     RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by~     cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or~     anorexia in young patients with malignancies who are undergoing radiation therapy and/or~     chemotherapy.~   "
180635|NCT01200589|"~     This was a multi-center, parallel, active comparator controlled, open-label, randomized (1:1)~     phase III study of single agent ofatumumab compared to single agent rituximab in subjects~     with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6~     months after completing treatment with single agent rituximab or a rituximab-containing~     regimen. Subjects must have attained a Complete Response or Partial Response to their last~     prior rituximab containing therapy lasting at least six months beyond the end of rituximab~     therapy. Subjects were to receive four weekly doses of single agent ofatumumab (1000 mg) or~     rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2~     months for four additional doses. Therefore, subjects were to receive a total of eight doses~     of anti-CD20 antibody over 9 months. Subjects were evaluated for response after completion of~     the first four doses of therapy, after six doses of therapy, and after completion of study~     therapy. Subjects were to be followed until the end of the designated follow-up period (total~     study duration of 200 weeks) or until they meet the withdrawal criteria.~      The primary objective of the study OMB157D 2303 was to demonstrate the efficacy of Arzerra~     based on the primary endpoint (Progression-free survival (PFS) as assessed by the IRC) in~     patients with Indolent B-cell Non-Hodgkin's Lymphoma Relapsed After Rituximab-Containing~     Regimen.~      The Independent Data Monitoring Committee (IDMC) met on November 22, 2015 and recommended the~     termination of the study due to futility (cut-off date = 12Jun2015). The IDMC reviewed~     analyses results for progression free survival (PFS), overall response rate (ORR), and~     overall survival (OS). Novartis accepted this recommendation and the study was closed.~      Final analysis was performed (cut-off date =19 Dec 2016). As the study was stopped for~     futility, the primary objective was not met and some secondary endpoints, supportive of~     primary objective (Duration of Response (DOR), time to next therapy, and pharmacokinetics)~     were removed as secondary end points.~   "
180636|NCT01200576|"~     This one-year observational study will monitor the contraceptive effectiveness, safety and~     acceptability of Zarin during the first year of use after the method has been approved for~     public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical~     support from Marie Stopes International and FHI. 300 women of reproductive age who selected~     Zarin as their primary method of contraception will be enrolled in the study at the MSM~     outreach sites and static clinics.~   "
180637|NCT01200563|"~     The purpose of this study is to evaluate the clinical and economic effectiveness of MIST~     Therapy vs NPWT vs MIST Therapy in conjunction with NPWT in the treatment of full thickness~     wounds presenting in the LTACH and SNF settings.~   "
180638|NCT01200550|"~     The purpose of this study is to evaluate symptoms control and impact on daily life from~     patients perspective using specific GERD Impact Scale(GIS) questionnaire. The another~     objective is to obtain local epidemiological data for Bosnia and Herzegovina regarding GERD~     treatment in primary care.~   "
180639|NCT01200537|"~     The purpose of this randomized controlled trial is to compare the efficacy and effect of~     luteal estradiol and combined oral contraceptive pills (COPC) on follicle recruitment and~     synchrony in a poor responder population. The randomized groups consist of: 1. patients~     receiving luteal estradiol prior to ovulation induction; and 2. patients receiving COCPs for~     1 month prior to ovulation induction. Follicle characteristics and serum biomarkers will be~     followed and compared in each group. Coefficient of variation will be used to evaluate~     follicle size discrepancy. Chi square analysis will be used to compare categorical variables~     between treatment groups. Both estradiol and COPCs are used clinically in assisted~     reproduction, so this study affords no additional risks to the participants.~   "
180640|NCT01200524|"~     A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days~     treatment in patients with posttraumatic neuralgia.~   "
180641|NCT01200511|"~     The purpose of this study is to describe visual outcomes, in particular spherical equivalent~     by manifest refraction and visual acuity across a range of distances, 6 months post~     implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with~     corneal astigmatism. Additionally, patient reported outcomes will be assessed.~   "
180642|NCT01200498|"~     The goal of this clinical research study is to learn if SB939 can help to control~     myelofibrosis. The safety of this drug will also be studied.~   "
180643|NCT01200485|"~     The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2~     cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of~     allopurinol. The safety of this treatment will also be studied.~   "
180644|NCT01200472|"~     STUDY DESIGN:~      This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group,~     efficacy and safety study in 30 patients with erosive osteoarthritis of interphalangeal~     joints. The study is composed of 4 phases: a pre-randomization phase for up to 35 days~     followed by a 91-day randomized, double-blind two arm treatment phase, followed by a 77-day~     open label treatment phase for all study participants and a 28-day observational follow-up~     phase. Efficacy of the double blind and open label phase will be assessed at study day 84 and~     168 after treatment start respectively.~      STUDY DURATION:~      The study length will be approximately 231 days for individual patients. With approximately a~     12 month recruitment period the study is planned to last from January 2010 until July 2011~     (19 months).~      STUDY OBJECTIVES:~      The primary objective is to evaluate the 84-day efficacy of apremilast 20 mg twice per day~     [BID], subsequent to a 7-day dose titration, compared with placebo, for the treatment of the~     symptoms of erosive hand osteoarthritis. Further objectives are to evaluate the effects on~     pain, disease activity, structural damage, quality of life, safety and tolerability.~   "
180645|NCT01200459|"~     The Social/Mobile Approach to Reduce Weight (SMART) study is a 24-month randomized control~     trial designed to evaluate the hypothesis that weight status at 24 months will be~     significantly better for the SMART intervention recipients than for those who receive the~     comparison condition.~   "
180646|NCT01200446|"~     Docosahexaenoic acid (DHA) is a component of fish oil that is known to support a healthy~     cardiovascular system, maintain brain function, reduce depression, and improve inflammatory~     diseases. The study hypothesis is that DHA supplementation will diminish exercise-induced~     bronchoconstriction and airway inflammation as compared to placebo.~   "
180647|NCT01200433|"~     The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood~     flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the~     investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for~     cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by~     near-infrared spectroscopy.~   "
180648|NCT01200420|"~     The main purpose of this study is to determine the safety and tolerability of multiple dosing~     of miravirsen in subjects infected with chronic hepatitis C.~      Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of~     miravirsen's effect on HCV viral titer.~   "
180649|NCT01200407|"~     The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine~     and Olmesartan medoxomil among Hypertensive Filipino patients.~   "
180652|NCT01200368|"~     Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group~     1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular~     pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP,~     Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar~     (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be~     open-label. The main purpose of the study is to determine if the immune responses to 13vPnC~     are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given~     with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to~     evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given~     with DTaP in healthy Japanese infants.~   "
180653|NCT01200355|"~     The purpose of this study is to compare the effects, good and/or bad, of posaconazole and~     micafungin in preventing fungal infections after chemotherapy for acute leukemia or~     myelodysplastic syndrome. When people take chemotherapy, they are more likely to get~     infections. Posaconazole has been approved for the prevention of fungal infections in~     patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome.~     Posaconazole is available only as an oral suspension and has to be given with food. After~     chemotherapy, many patients are not able to tolerate food or oral medication because of~     severe mucositis. Patients unable to tolerate food and oral medications cannot take~     posaconazole.~      Micafungin is an antifungal medication that is given only intravenously. Micafungin is~     approved for the treatment of certain fungal infections and for preventing fungal infections~     in patients who receive bone marrow transplant. The investigators know that micafungin is~     safe. Micafungin has not been tested for the prevention of fungal infections in patients~     receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is~     given by vein, it can be given even in patients who cannot take food or medications by mouth~     after chemotherapy. In this study the investigators want to compare micafungin to~     posaconazole when given for the prevention of fungal infections in leukemia and~     myelodysplastic syndrome patients.~   "
180654|NCT01200342|"~     The goal of this clinical research is to learn if the combination of Genasense (oblimersen),~     carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety~     of this combination will also be studied.~   "
180655|NCT01200329|"~     The goal of this clinical research study is to learn if the combination of gemcitabine,~     busulfan, and melphalan, when given before a stem cell transplant, can help to control~     refractory Hodgkin's disease. The safety of this study treatment will also be studied.~   "
180656|NCT01200316|"~     After having abdominal surgery, patients often experience a lack of bowel function that can~     cause nausea, vomiting, abdominal swelling, pain, and/or discomfort. This is known as~     post-operative ileus. Patients are usually not allowed to leave the hospital until their~     doctor is sure that their bowel function has returned.~      The goal of this clinical research study is to compare using a rocking chair to the standard~     of care in improving post-operative ileus after abdominal surgery.~   "
180657|NCT01200303|"~     The purpose of this study is to evaluate the performance of a non-cathartic,~     computer-assisted form of CT Colonography (Virtual Colonoscopy) for detection of~     pre-cancerous colon polyps in a group of asymptomatic screening patients.~   "
180658|NCT01200290|"~     The purpose of this trial is to explore the effect of LY2127399 on those antibodies that are~     a barrier to kidney transplant. Transplantation is currently the definitive treatment for~     End-Stage Renal Disease (ESRD), providing prolonged survival and improved quality of life.~   "
180659|NCT01200277|"~     The standard care in patients with a painful osteoporotic vertebral compression fracture~     (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive~     technique for pain treatment in which bone cement is injected in the fractured vertebra.~     Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV~     while an unmasked but controlled RCT found significantly better pain relief after PV at~     acceptable costs.~   "
180660|NCT01200264|"~     This is a Phase II, open label, investigator-initiated study to be done at Duke University~     Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have~     failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment,~     the patient must have received biologic therapy without achieving a response of almost~     clear or clear according to PGA or has not responded with a 75% reduction of PASI score.~     Once deemed eligible, subjects will return for a baseline visit and receive Apremilast~     therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects~     will be evaluated 28 days after last dose of Apremilast for safety and efficacy.~   "
180661|NCT01200251|"~     A internally controlled, single-blinded, randomized controlled trial to investigate the use~     of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who~     suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and~     IRB approval have been obtained.~   "
180662|NCT01200238|"~     STA-9090 is drug which inactivates or blocks the work of a protein called Heat Shock Protein~     90 or HSP90. HSP90 is a protein that helps some molecules inside the cells have the right~     shape. By stopping it's activity, these molecules never get to have the right structure to be~     functional and they are destroyed. We believe that if we stop the activity of HSP90, the~     rapidly dividing cells in the tumor(s) will slow down since their proteins will not be~     functional without the help of HSP90.~   "
180663|NCT01200225|"~     This prospective observational study will assess the insulin resistance and its impact on~     sustained virological response in patients with hepatitis C treated with Pegasys and Copegus.~     Data will be collected from each patient during the up to 72 weeks of treatment and for 24~     weeks of treatment-free follow-up.~   "
180683|NCT01199965|"~     Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation~     (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.~      Identify whether there are clinically significant differences in the tolerability of MAP0004~     between smokers and non-smokers.~   "
180802|NCT01198379|"~     The study is prospectively initiated to: (1) evaluate the alterations in platelet function to~     aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney~     disease undergoing hemodialysis, and (2) compare the incidence of vascular events (myocardial~     infarction, cardiac death, stroke, vascular access thrombosis, or revascularization~     procedure) and the safety profile among placebo-treated, aspirin-resistant and~     aspirin-sensitive patients.~   "
180664|NCT01200212|"~     The purpose of this study is to determine whether~        -  Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent~          results of the AVADO study report a similar result for the combination of docetaxel and~          bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of~          bevacizumab.~        -  As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens~          with bevacizumab and at least 2 cytotoxic agents should be investigated.~        -  Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is~          therefore a reasonable choice.~        -  Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to~          improve tolerability without compromising efficacy.~        -  Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months.~        -  Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2~          much more accepted in daily practice. Better comparability with DBX, if both arms have~          75mg/m2 docetaxel as assumed.~   "
180665|NCT01200199|"~     The purpose of this study is to contribute to the validation of an electronic daily diary to~     assess symptoms in patients with varicose veins.~   "
180666|NCT01200186|"~     Prospective, non-interventional, multi-center study. Each subject will be followed for up to~     twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin~     Only Pill). For each subject demographic data and medical history will be documented at Visit~     1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and~     wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2~     (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.~   "
180667|NCT01200173|"~     This multicentric, randomized, double-blind and controlled study aims to examine the effect~     of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001~     (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common~     infectious diseases (cumulated number of infections during the intervention period: primary~     criteria) in children aged 3-6 years, attending day care centers.Volunteers received either~     200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a~     1-month follow-up.~   "
180668|NCT01200160|"~     Post-Marketing Observational study of Niaspan® tablet in accordance with each country~     regulations. This study will be conducted in a prospective, single-arm, multi-center format.~     As this study is observational in nature, the follow-up of subject's is not prescriptive in~     nature and is according to the judgment of the physician (investigator in the course of~     treatment for each patient), within the period of observation of 12 months. This includes an~     enrollment period of 6 months in which each subject will be observed for approximately 6~     months. Examinations, diagnostic measures, findings and observations performed as per usual~     medical practice during the observation period will be recorded on Case Report Forms (CRFs)~     by the investigator or site staffs according to the protocol.~   "
180669|NCT01200147|"~     Dysphagia is a common reason for referal to the investigators Gastoenterology service. As~     many as 14% of patients undergoing radiological studies for dysphagia are found to have~     schatzki rings. Current recommendations for treatment of patients with symptomatic Schatzki~     rings are based on ancedotal experience and uncontrolled studies. The only randomized study~     on comparison of techniques the investigators were able to locate was published in 2000 and~     included only 26 patients. This study demonstrated that the biopsy techinque was as effective~     as and better tolerated than the standard dilation technique. Considering that the cost and~     time required for dilatation is greater than the basic biopsy technique, significant cost~     savings could be achieved using the biopsy technique. As well, patient satisfaction is an~     important factor considering that Schatzki rings can recur and repeated endoscopy is often~     required. Therefore, a study that shows a technique to be as or better than the current~     standard in effectiveness, cost, time, and patient comfort could lead to shift in current~     practice.~   "
180670|NCT01200134|"~     Background :~      In malignant gliomas, hypoxia is associated with tumour angiogenesis and tumour progression.~     This multidisciplinary preclinical and clinical project aims to validate the use of 18F-FMISO~     as a hypoxic marker for diagnosis, treatment and follow-up of malignant gliomas. Indeed,~     non-invasive methods of imagery such as Positron Emission Tomography (PET) and biological~     methods (after surgical resection) to detect the endogenous expression of factors induced by~     the hypoxia would allow to identify hypoxic areas. Identifying, with accuracy, the hypoxic~     areas could allow the clinicians to evaluate the response to the anti-angiogenic agents~     (preliminary validation in the preclinical project) and to optimize the combination of the~     anti-VEGF treatments with other conventional therapeutic approaches (radiotherapy,~     chemotherapy or other molecules).~      Research project :~      This research project includes 3 steps : first the investigators will establish the 18F-FMISO~     production technique for clinical application at CYCERON PET center. The second step consists~     in the preclinical validation of 18F-FMISO as a hypoxic marker and as a powerful tool for~     evaluating the therapeutical efficiency of anti-angiogenic treatment (sutent) in experimental~     rat gliomas. The third step is the clinical trial HypOnco. This research proposal aims to~     develop and use non invasive imaging methods (18F-FMISO with PET) and biological methods~     (after surgical resection) to detect hypoxic (HIF1 and HIF2) and angiogenic (VEGF and EPO)~     regions in different malignant gliomas with different degrees of vascularization (15 patients~     with grade III gliomas and 15 patients with grade IV glioblastomas). Within the same patient~     18F-FMISO as a hypoxic index will be performed. A magnetic resonance imaging examination~     (MRI) including perfusion sequences and MR spectroscopy will also be assessed for each~     patient. Following this imaging protocol, surgical resection will be performed allowing us to~     study expression of endogenous factors induced by hypoxia and angiogenic factors by real time~     RT-PCR and in immunohistochemistry.~      The data obtained will enable us to establish :~        -  a hypoxic index (18F-FMISO with PET).~        -  an index of hypoxic factor expression (HIFs)~        -  an angiogenic index (VEGF, EPO, vascular markers)~      The investigators will characterize the links between these data and also with the following~     parameters:~        -  clinical (age, Karnofsky performance status, survival)~        -  MR parameters included perfusion and spectroscopy~        -  histological (necrosis, cellular proliferation, atypical cell abnormalities,~          vascularization).~      Expected results and clinical advantages~        -  To establish the 18F-FMISO production technique~        -  To propose the 18F-FMISO as a non-invasive marker for efficacy of antiangiogenic~          treatment in a preclinical study.~        -  To define the relationship between the 18F-FMISO uptake and tumour grade, patient~          survival, tumour recurrence, expression of hypoxic and angiogenic factors and tumour~          vascularisation.~        -  To provide a hypoxic index in cerebral tumours from 18F-FMISO PET, allowing diagnosis~          and prognosis improvement for optimal treatment orientation and strategy.~      In the field of the clinical applications, this tool will allow to :~        -  Optimize radiotherapy treatment by identifying with accuracy, using 18F-FMISO PET, the~          most hypoxic areas which are also the most radio resistant.~        -  Evaluate antiangiogenic therapy efficacy~   "
180671|NCT01200121|"~     Malignant ascites represents a severe clinical problem for physicians and patients being~     confronted with this common symptom of advanced-stage gastrointestinal cancer. Unfortunately,~     there is no standardized and evidence-based treatment for malignant ascites and therapies~     which are commonly being used are only temporarily effective. Newer modes of therapy, such as~     the application of the tri-functional antibody catumaxomab, are associated with significant~     side effects and are limited to patients in stages of good overall performance. Therefore,~     there is still an urgent need for more effective, longer-lasting, and less toxic modes of~     treatment for peritoneal effusions caused by gastrointestinal cancers.~      Preclinical data strongly suggest that bevacizumab might be a very effective agent for the~     treatment of malignant ascites, which is in large part caused by the~     hyperpermeability-promoting factor VEGF. Emerging clinical results from cancer patients with~     malignant ascites treated with bevacizumab add further support to this idea. Bevacizumab has~     been tested in a variety of large clinical trials, has a good toxicity profile, and is~     effective in a number of human cancers underlying malignant ascites.~      In the present study, Bevacizumab will be administered as an intraperitoneal infusion at an~     absolute standardized dosage of 400 mg. This dosage was chosen because it is comparable to~     the approved standard dosage for intravenous administration which was also used in both~     studies reporting the successful and safe intraperitoneal administration of Bevacizumab to~     patients with malignant ascites. Finally, a standardized dosage seems more practical in the~     particular patient population treated in this study.~   "
180672|NCT01200108|"~     The goal of treatment with AICS is weaning from oral corticosteroids, i.e. a reduction of the~     oral corticosteroid dose. An anticipated treatment benefit of AICS is a reduction of oral~     corticosteroid dose and stability/improvement of clinical parameters related to asthma in the~     targeted subject population. Ultimately, the goal is to free subjects with severe asthma from~     the burden of chronic oral steroid therapy.~   "
180673|NCT01200095|"~     This study presents an arthroscopic-assisted PCL reconstruction using femoral knot/press-fit~     technique with a periosteum-enveloping graft in tibial tunnel. The investigators evaluated~     the results of patients with PCL ruptures, who undergoing PCL reconstruction using this~     unique technique.~   "
180717|NCT01199510|"~     The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA®~     Lubricating Drops) plus standard of care to standard of care alone, in subjects with a~     history of intermittent eye irritation or dryness related to environmental factors and~     scheduled for routine cataract surgery.~   "
180674|NCT01200082|"~     The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary~     elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary~     diseases. The investigators rationale in this project is that the discovery of biomarkers~     specific to liver injury would provide the foundation for a specific and non-invasive tool to~     evaluate disease prognosis, determine patients with higher risk of developing end-stage liver~     diseases, and determine patients with higher risk of recurrence of hepatobiliary~     complications after liver transplant.~      Patients on the liver transplant list are continuously monitored during their hospitalization~     and are scheduled for follow-up visits for 12 months after their release post-surgery.~     Disease progression will be evaluated by monitoring MELD scores, survival, incidence of liver~     transplant, and incidence of complications related to hepatobiliary conditions such as fluid~     retention, GI bleeding, encephalopathy, and biliary stricture complications.~   "
180675|NCT01200069|"~     Post-procedure myalgia (muscle ache) is a well-known and common complication of~     Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in~     approximately 50% of these cases. The pain is usually described as muscle soreness, similar~     to that resulting from strenuous exercise. The myalgias typically begin shortly after the~     procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of~     patients considered prevention significant and would be willing to pay a median of $33 out of~     pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a~     further financial burden if these patients are unable to return to work or resume previous~     daily activities in the days following the procedure. An agent that could treat and possibly~     even prevent these myalgias has the potential to be very beneficial to these patients. IV~     ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and~     Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an~     adjunct to opioid analgesics, and for the reduction of fever.~   "
180676|NCT01200056|"~     While statin treatment may induce plaque regression, the effect of statin on plaque~     composition with varying doses is unknown. This study assessed such effects by volumetric~     virtual histology intravascular ultrasound (VH-IVUS).~      In this prospective, randomized, double-blinded pilot study, statin-naïve patients with~     stable angina requiring percutaneous coronary intervention (PCI) were randomized to receive 6~     months of either atorvastatin 10mg or 40 mg daily. VH-IVUS was performed in all non-PCI~     lesions at baseline and 6 months; all analyses were performed by core laboratory.~   "
180677|NCT01200043|"~     The sugar fructose has been implicated not just as a cause of obesity, but as a cause of the~     metabolic diseases that go along with obesity, termed metabolic syndrome. Obese children~     with metabolic disease will be studied before and after 10 days of a fructose restricted~     diet. The question is whether their co-morbidities will improve, even if weight remains~     constant.~   "
180678|NCT01200030|"~     The investigators hypothesize that application of electrical stimulation would augment the~     effects of exercises in patients with stroke. Combined electrical stimulation with exercises~     for 6 weeks would lead to earlier and greater improvement in motor functions when compared~     with placebo-stimulation with exercises.~   "
180679|NCT01200017|"~     This protocol provides expanded access to bone marrow transplants for children who lack a~     histocompatible (tissue matched) stem cell or bone marrow donor when an alternative donor~     (unrelated donor or half-matched related donor) is available to donate. In this procedure,~     some of the blood forming cells (the stem cells) are collected from the blood of a partially~     human leukocyte antigen (HLA) matched (haploidentical) donor and are transplanted into the~     patient (the recipient) after administration of a conditioning regimen. A conditioning~     regimen consists of chemotherapy and sometimes radiation to the entire body (total body~     irradiation, or TBI), which is meant to destroy the cancer cells and suppress the recipient's~     immune system to allow the transplanted cells to take (grow). A major problem after a~     transplant from an alternative donor is increased risk of Graft-versus-Host Disease (GVHD),~     which occurs when donor T cells (white blood cells that are involved with the body's immune~     response) attack other tissues or organs like the skin, liver and intestines of the~     transplant recipient. In this study, stem cells that are obtained from a partially-matched~     donor will be highly purified using the investigational CliniMACS® stem cell selection device~     in an effort to achieve specific T cell target values. The primary aim of the study is to~     help improve overall survival with haploidentical stem cell transplant in a high risk patient~     population by limiting the complication of GVHD.~   "
180680|NCT01200004|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Grifola frondosa extract, azacitidine, and lenalidomide that can be given to~     patients with advanced cancer. The safety of this drug combination will also be studied.~   "
180681|NCT01199991|"~     Dual-energy x-ray absorptiometry (DXA) is currently the most widely used tool for determining~     bone density. However, most experts consider DXA an imperfect and intermediate technology.~     DXA is subject to artifact from arthritis and body composition, and also cannot account for~     geometric or material properties of bone which are also important components of bone~     strength.~      Xtreme CT (high-resolution peripheral quantitative computed tomography, HR-pQCT) is a new~     technology with dramatically improved spatial resolution. It is able to define bones'~     cortical and trabecular surfaces in a three-dimensional manner, and therefore provides~     information on bone microarchitecture as well as bone density. As such, it may provide new~     information about characteristics of bone strength.~      The purpose of this study is to compare Xtreme CT to DXA measurements of bone density, and~     also to generate a normative database of healthy young adults. This cross-sectional study~     involves a single visit where both Xtreme CT and DXA measurements will be obtained for a~     single time-point. This normative database will allow us to generate clinically relevant~     comparisons between the two imaging technologies.~   "
180682|NCT01199978|"~     In this research study we are looking at another type of radiation called proton radiation~     which is known to spare surrounding normal tissues from radiation. The proton radiation will~     be delivered using fractionated stereotactic radiotherapy (FSRT) to improve localization of~     the small tumor target. Proton radiation delivers minimal radiation beyond the area of the~     tumor. This may reduce side effects that patients would normally experience with conventional~     radiation therapy. In this research study, we are looking to determine the effects of~     fractionated proton radiotherapy on long-term hearing preservation and controlling tumor~     growth.~   "
180684|NCT01199952|"~     Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the~     treatment group than in the control group.~      Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion~     in women who choose combined hormonal contraception (CHC) and who receive a three-week~     educational phone call as compared to women who do not receive the intervention.~      Secondary Aims~        -  To describe the most common concerns and logistical problems women experience with~          initiating and adhering to CHC after abortion.~        -  To describe the concerns that lead to discontinuation or method change. *To assess~          feasibility of conducting a follow-up telephone call in this population This is a~          randomized, controlled trial to assess the effect of a three-week follow-up phone call~          in women who choose combined hormonal contraception on the day of their abortion at the~          San Francisco General Hospital Women's Options Center. Subjects randomized to the~          treatment group will receive an interventional phone call three weeks after their~          abortion; participants randomized to the control group will not receive the call. All~          subjects will receive a follow-up call six weeks after their abortion to assess and~          compare method use between the two groups. Calls will be made at three- and six-weeks~          post abortion in order to give subjects enough time to initiate CHC and to assess~          continuation into the second month of the method. Data will be collected at baseline,~          during the intervention for the treatment group and during the final follow-up call for~          both groups. The primary outcome is use of an effective contraceptive six weeks after~          abortion.~   "
180685|NCT01199939|"~     This study is a Phase II single arm, open-label, multicenter, study of 50 human~     immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine~     (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to~     evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of~     patients with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected~     patients. In addition to general safety parameter measurements, this trial will also assess~     changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will~     occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the~     treatment period is 48 weeks. The end of study endpoint will be met by either completing the~     Week 48 visit, or by early termination from the study for any reason.~   "
180686|NCT01199926|"~     The study was designed to assess the effects of vitamin D supplementation during exercise~     training on body composition, muscle function, and glucose tolerance. The investigators~     hypothesis for these studies is that vitamin D supplementation enhances exercise-induced~     increases in strength and lean mass, potentially through enhancing insulin sensitivity and~     reducing inflammation.~   "
180687|NCT01199913|"~     The use of desflurane in elderly subjects (>65 years old) undergoing general anesthesia with~     endotracheal intubation will result in decreased POCD compared to sevoflurane if the~     patient's MAP is within 20% of the patient's baseline and the cerebral suppression state~     index stays within the moderately anesthetized range during general anesthesia.~   "
180688|NCT01199900|"~     This study will investigate the effect of a single dose of PF-04171327 or prednisone on~     calculated measures of glucose tolerance and insulin resistance by using a modified oral~     glucose tolerance test~   "
180689|NCT01199887|"~     This is an open label, Phase One, multicenter study, designed to evaluate the safety,~     tolerability, to explore the biologic effects, and to explore the clinical effects of the~     following doses of IW001: 0.1mg/day, 0.5 mg/day, and 1.0 mg/day, when administered once a day~     orally for 24 weeks in patients with IPF.~   "
180690|NCT01199874|"~     Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all~     diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and~     Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy~     data in low income countries had prevented WHO from making a universal recommendation of~     their use until recently. This study will be conducted in Pakistan and will look at two~     objectives:~        1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of~          life and at 6, 10 and 14 weeks of life.~        2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of~          vaccine administration with infants whose breast feeding is withheld for one hour before~          and after vaccine administration.~   "
180691|NCT01199861|"~     This study will evaluate the effect of treatment with fingolimod on the immune response~     following seasonal influenza vaccination and tetanus booster injection in patients with~     relapsing MS.~   "
180692|NCT01199848|"~     The purpose of this study is to test whether compounds found in strawberries (polyphenolics~     which are typically found in berry products, tea, coffee, red wine, and chocolate) will help~     reduce insulin resistance and inflammation, known factors in your blood associated with~     disease risk, when eaten with a standard high fat/carbohydrate meal.~   "
180693|NCT01199835|"~     The aim of the study is to investigate the long time effects of high and low intake of dairy~     products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation~     and appetite regulation in moderately overweight men and women over 24 weeks.~   "
180694|NCT01199822|"~     Participants in this single-center, open-label, dose-escalation, Phase 1 study will initially~     receive intravenous (IV) olaratumab once every 2 weeks or on Days 1 and 8 every 3 weeks for 6~     weeks (one cycle). After the first cycle, participants experiencing an overall response of~     complete response (CR), partial response (PR), or stable disease (SD) will continue to~     receive olaratumab at their cohort dose and schedule until there is evidence of progressive~     disease (PD), or until other withdrawal criteria are met.~   "
180695|NCT01199809|"~     This randomized, double-blind. placebo-controlled study will assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics of multiple doses of RO5310074 in patients with~     psoriatic arthritis who have or have had an inadequate response to oral disease-modifying~     antirheumatic drugs (DMARDs) or non-steroidal anti-rheumatic drugs (NSAIDs). Patients will be~     randomized in cohorts to receive either 6 intravenous doses of RO5310074 or placebo.~     Anticipated time on study treatment is 12 weeks.~   "
180734|NCT01199289|"~     The purpose of this study is to determine if AMG 827 is effective compared to placebo as~     measured by change in Asthma Control Questionnaire (ACQ) composite scores.~   "
180803|NCT01198366|"~     AERAS-402 will be given to infants of at least 16 weeks of age who have already been~     vaccinated with BCG to determine if AERAS-402 will increase protection of infants to~     tuberculosis.~   "
180696|NCT01199783|"~     Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in~     treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment~     with Vancomycin (effective blood-plasma concentration of 15 mg/l). In case of~     microbiologically confirmed gram-negative co-infection effective antibiotic treatment~     according to microbiologic analysis will be administered upon medical decision in both~     therapy groups. The study will be carried out as a randomized, open label study.~   "
180697|NCT01199770|"~     Investigators are interested in learning how appetite responds to pasta containing different~     amounts of protein and fiber when provided in two different portion sizes.~      In this research study, subjects will be asked to eat an entire pasta serving containing~     different amounts of protein and fiber mixtures. Subjects will be asked to do this on six~     separate occasions. One time subjects will not receive pasta, only water.~      After the pasta serving, there will be a buffet of deli style lunch items and subjects may~     eat as much they desire. Thereafter subjects will describe their feelings of hunger, fullness~     and desire to eat for 3 hours. In addition, blood will be taken throughout the study period~     to determine how eating pasta servings in different portion sizes impacts certain hormones~     released from the intestine, and therefore how they influence appetite. All study visits will~     take approximately 4 ½ - 5 hours.~   "
180698|NCT01199757|"~     Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both~     ocular and nasal symptoms have a greater burden of illness and lower quality of life than~     patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both~     nasal and ocular symptoms. The purpose of this study was to evaluate the differences in~     symptom control (both perceptually and objectively) and resource use for patients with~     current seasonal AR.~   "
180699|NCT01199744|"~     To collect background information of patients receiving a prescription for Relenza® and study~     risk factors etc. for adverse drug reactions collected through spontaneous reporting. In~     particular, to characterize the types and incidences of adverse events, serious adverse~     events, and adverse drug reactions and to investigate risk factors for them in patient~     populations that are regarded to be at high risk for novel influenza A (H1N1)and in which the~     use experience of Relenza® has not been enough (such as pregnant women, infants, elderly~     persons, and those with decreased physical function) in accordance with the PFSB/SD~     Notification 0904, No.2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW,~     dated 4th September 2009.~      To compare the data with the safety data collected in overseas sentinel site monitoring~     programs.~   "
180700|NCT01199731|"~     This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced adult~     subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and~     200 mg once daily with a control arm of open-label etravirine (ETV) 200 mg twice daily. The~     background ART for all three arms will be darunavir/ritonavir (DRV/r) 600 mg/100 mg twice~     daily plus raltegravir (RAL) 400 mg twice daily. Antiviral activity, safety, PK, and~     development of viral resistance will be evaluated.~   "
180701|NCT01199718|"~     This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest~     safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple~     myeloma.~   "
180702|NCT01199705|"~     The objective of this study is to assess the efficacy, safety, tolerability, and~     pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary~     immunodeficiency (PID). In addition, the study will assess the health-related quality of life~     and pharmacoeconomic aspects related to treatment with IgPro20.~   "
180703|NCT01199692|"~     Traditional dietary, lifestyle, behavioral and pharmacologic treatment strategies have proven~     relatively ineffective for treating obesity, and once metabolic abnormalities such as Type 2~     Diabetes (T2D) develop, definitive strategies to prevent major cardiovascular events remain~     elusive. More positively, the identification of a scientific resolution for obesity and T2D~     in the short-term is not outside the bounds of reality. Because the complexity of metabolic~     regulation is likely to include already characterized biomarkers, as well as other~     unidentified factors, it is logical to sample subjects of various ages, gender, ethnicity,~     body mass distribution, dietary habits, exercise habits, medication requirements, and disease~     states to discover associations and pathways related to the restoration of normal metabolism.~   "
180704|NCT01199679|"~     The purpose of this study is to determine the safety and effectiveness of two separate~     procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two~     therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band~     Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the~     Cook® Duette™ Multi-Band Mucosectomy device.~   "
180705|NCT01199666|"~     Although the investigators have reached the Healthy People 2010 goal of 80% coverage among~     U.S. children 19-35 months of age for the primary immunization series, 20% of children still~     remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of~     vaccine preventable disease persist. Immunization reminder-recalls have been shown to be~     successful, but have been limited by the ability to identify and reach large target~     populations in a real-time, automated fashion. Reminder-recalls via text message may offer an~     innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a~     cell phone. Prior research by our team suggests that text messages reminder recalls may be an~     effective tool to remind parents about their children's vaccines. In this study, the~     investigators will demonstrate the effectiveness of tailored text message appointment and~     immunization reminders linked to a well-established and functional immunization registry to~     increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The~     investigators will target parents of young children from an underserved population that is~     primarily Latino, with low socioeconomic status.~   "
180706|NCT01199653|"~     The purpose of this study is to find whether to operate or treat conservatively dislocated~     midshaft clavicle fractures.~   "
180707|NCT01199640|"~     This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy~     in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose~     cohorts enrolling a total of 50 patients. Efficacy was assessed by comparing the numbers of~     new gadolinium-enhancing brain lesions during the screening and treatment periods.~   "
180804|NCT01198353|"~     This study is designed with the aim to evaluate the clinical effect of the overlapped~     switching to ziprasidone as well as the efficacy and safe metabolic profile of ziprasidone.~   "
180708|NCT01199627|"~     The bleeding caused by hip replacement surgery (CRT) is an important source of demand for~     blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing~     bleeding associated with other surgeries and CRT results have been positive, but the variety~     of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in~     reducing bleeding caused by surgery of total hip replacement.~      PATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform~     hip replacement surgery and cementless unilateral total that have signed the informed~     consent.~      Group A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional~     anesthesia, and before the start of surgery.~      2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after~     the first administration.~      Group B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional~     anesthesia, and before the start of surgery.~      2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at~     three hours after the first administration.~      Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the~     completion of regional anesthesia, and before the start of surgery.~      2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after~     the first administration.~      STATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events~   "
180709|NCT01199614|"~     This is an open-label study of PTH(1-84) treatment that seeks:~        1. To determine the actions of PTH(1-84) to provide long term control of serum calcium and~          urinary calcium excretion with use of standard amounts of calcium and vitamin D~          supplementation.~        2. To determine the extent to which PTH(1-84) improves quality-of-life on long-term basis.~        3. To establish the safety of PTH(1-84) when administered for up to 12 years.~        4. To attempt to quantify improvements in the typical signs/symptoms of hypoparathyroidism~          post PTH administration.~      There will be one visit conducted every six months in the study offices of the principal~     investigator, Dr. John Bilezikian. In addition to these visits, there will be, for new~     patients who have not used PTH (1-84) before, a Screening Visit four weeks prior to the~     baseline visit for the purpose of performing screening labs as well as a Pre-Baseline Local~     Quest Lab performed to ensure stability prior to Baseline.~   "
180710|NCT01199601|"~     Baseline information indicates there are measurable levels of hepatitis B SAg and low~     utilization of postpartum contraception, correct breastfeeding practices, or adherence to~     infant vaccination schedules in Kabul, Afghanistan. This intervention will randomize~     hospitals to assess the following aims:~      Aim 1: To determine whether the re-training and assignment of health care providers dedicated~     to intrapartum rapid testing and post-partum counseling will positively impact maternal and~     neonatal health indicators as compared to utilization of existing health providers for these~     services among women delivering in publish health maternity hospitals in Kabul, Afghanistan.~      Aim 2: To assess whether patients randomized to the intervention and their spouses perceive~     value in concentrated post-partum counseling.~      Aim 3: To investigate whether an intervention providing immediate post-partum provision of a~     long-acting family planning method would be feasible and acceptable to both men and women in~     Kabul, Afghanistan.~   "
180711|NCT01199588|"~     This study is for subjects with a venous leg ulcer. The study is being done to determine if~     NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.~   "
180712|NCT01199575|"~     The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC) is conducting a two-arm,~     multi-center phase II trial of Revlimid® and rituximab for Relapsed or Refractory CLL for~     patients under the age of 65 and patients 65 years and older.~      Lenalidomide (Revlimid) is an immunomodulatory agent with promising clinical activity in CLL~     and is FDA approved for treatment of relapsed multiple myeloma and 5q-myelodysplastic~     syndrome. Rituximab (Rituxan) is a monoclonal antibody to CD20 that is approved for the~     treatment of CLL.~      The primary objective of this study is to determine the overall response rate of the~     combination of Revlimid® and rituximab in previously treated CLL patients. All patients will~     receive treatment with Revlimid® starting at a low dose that will be dose escalated based on~     individual patient tolerability. The combination of Revlimid and Rituximab will be~     administered for a maximum of 7 cycles. Patients with residual leukemia following seven~     cycles of treatment with the combination may elect to continue on protocol for an additional~     6 cycles of single agent Revlimid® consolidation.~   "
180713|NCT01199562|"~     RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV)~     infection caused by a stem cell transplant.~      PURPOSE:This clinical trial studies infection prophylaxis and management in treating~     cytomegalovirus infection in patients with hematologic malignancies previously treated with~     donor stem cell transplant.~   "
180714|NCT01199549|"~     Cardiovascular disease (CVD) continues to rank high among the leading causes of morbidity and~     mortality in adults worldwide. While diet and increased physical activity constitute the~     primary preventive health approach, the role of plant-based bioactive compounds has attracted~     much attention due to their unique cardio-protective benefits. Several epidemiological~     studies suggest that dietary patterns characterized by relatively high intake of fruits and~     vegetables are significantly associated with reduced risks of coronary heart disease and~     stroke.~      Dietary bioactive compounds are potent anti-oxidants and anti-inflammatory agents, thereby~     counteracting oxidative damage and inflammation, which underlie the pathogenesis of CVD.~      However, this area is really lacking of a good set of chemistry, bioavailability and efficacy~     data that is vital for nutrition researchers and doctors to emphasize their role in the~     prevention and treatment of clinical outcomes at different stage of CVD, and dissemination of~     this information to the general public.~      Cambridge Theranostics has focused its efforts on developing products that can prevent the~     damaging oxidation of lipoproteins that leads to heart attacks and stroke, and on~     understanding the cause of that damage.~      Extensive literature shows that Lycopene, Resveratrol and Soy Isoflavones are key ingredients~     in diets that long been known to reduce the risk of heart attack and stroke. However, they~     are normally poorly absorbed (not 'bioavailable'). The investigators unique production~     process presents Lycopene, Soy Isoflavones and Resveratrol to the body in a form that it can~     easily absorb and use.~      The aim of the current study is to perform and compare bioavailability and absorption of~     those three different dietary antioxidants and their combinations. The study is funded by~     Cambridge Theranostics and will be done on healthy volunteers of various ages with 30 people~     in each product group. It will be conducted on the primacies of Cambridge Theranostics in~     Babraham Research Campus. And managed by the team of experienced professionals employed by~     Cambridge Theranostics. The study will last about 12 months including recruitment process,~     screening process, periodical blood samples collection and examination and statistical~     analyses at the end.~   "
180715|NCT01199536|"~     The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to~     estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the~     end of treatment and 52 weeks from the therapy start~   "
180716|NCT01199523|"~     The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on~     ECG (electrocardiogram) measurements.~   "
180718|NCT01199497|"~     Multicenter clinical trial, phase III, controlled by active medicine, double-blind,~     randomized, enroll 208 subjects, above 12 years old, that suffer acute inflammation upper~     airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3~     and no more than 5 consecutive days (without systemic/topic use of medication during this~     period) followed by nasal congestion, with or without associate other nasal symptoms~     (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated~     in 2 parallel groups, and will receive the medicines of study, according of the~     randomization.~   "
180719|NCT01199484|"~     Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a~     potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that~     SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization~     from evolving towards persistent allergy. The aim of this study was to evaluate the safety~     and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment~     alternative to elimination diet.~      Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs~     were included in this multicenter study and were randomly divided into two different groups.~     Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30~     (group B: control group) were kept on a milk-free diet and followed-up on for one year.~   "
180720|NCT01199471|"~     This registry is primarily aiming to demonstrate the correlation between good practices of~     anesthesiologists and patient related outcomes including decreased overall anesthesia cost.~     The investigators would also like to demonstrate how the training background, and experience~     in inhalational anesthesia of the anesthesiologist influence their daily practice. At the end~     of the registry, the investigators would be able to demonstrate the influence of different~     practice pattern on patient related outcomes between the sites at which anesthesiologists~     follow modern anesthesiology practice based on their training/experience background and at~     which anesthesiologists do not follow same type of practice due to lack of their inhalational~     anesthesia training/experience.~   "
180721|NCT01199458|"~     This study evaluates the effects of adding an opioid (alfentanil) during anesthesia induction~     with respect to the barrierpressure in the esophagogastric junction.~      The secondary aim was to investigate whether the effect of cricoid pressure influences the~     barrierpressure.~   "
180722|NCT01199445|"~     The project aims to evaluate the potential impact triple fortified rice grains, mixed into~     natural rice grains, can have on vitamin A status if fed to school children in Southern~     Thailand. Within a 60 day intervention study, changes in vitamin A status in young children~     fed the fortified rice compared to children consuming non-fortified rice will be assessed.~   "
180723|NCT01199432|"~     This is a phase IV, prospective, single-center, open-label, randomized, controlled study.~     Eligible patients are randomly assigned into three groups. The investigators propose to~     evaluate and compare the efficacy and safety of different neoadjuvant chemotherapies in women~     with primary breast cancer.~   "
180724|NCT01199419|"~     The objective of the present study is to analyze the cost-effectiveness of percutaneous~     coronary intervention (PCI) using TAXUS stents compared to the costs of coronary artery~     bypass surgery (CABG) in patients with multivessel coronary artery disease (CAD) in the first~     5 years and then 10 years after intervention. Multivessel PCI or CABG was performed in 114 or~     93 patients, respectively. Clinical outcomes, in terms of incidence of acute myocardial~     infarction (AMI), all-cause death, target vessel revascularization (TVR) and stroke, resource~     use and costs are analyzed prospectively over a 5 and 10-year follow-up (FUP) period. Overall~     costs consist of the baseline costs of the index procedure (PCI or CABG), clinical and~     angiographic procedure-related treatments during the entire FUP. The primary endpoint is~     cost-effectiveness and clinical effectiveness, defined as the reduction of the composite of~     major adverse cardiac and cerebrovascular events (MACCE).~   "
180725|NCT01199406|"~     To determine the effect of combined intracutaneous infiltration and intraperitoneal~     instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic~     cholecystectomy on abdominal pain up to 24 hours after surgery.~   "
180726|NCT01199393|"~     The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes~     can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.~   "
180727|NCT01199380|"~     Depression related vulnerabilities are highly comorbid with smoking behavior and dramatically~     reduce cessation rates among both community and clinical samples. Previous research has~     examined the efficacy of cognitive-behavioral treatment for individuals with a history of~     major depressive disorder (MDD) in standard cessation treatment. A broader health impact can~     be achieved by targeting individuals with current elevated depressive symptoms to address~     their association with cessation failure. Thus the objective of the present proposal is to~     conduct a Stage II randomized controlled trial (RCT) comparing the behavioral activation~     intervention to standard treatment among a similar community sample of 200 adult smokers with~     elevated depressive symptoms. Participants will be followed over 52 weeks post-quit date and~     the larger sample size will allow for more complex analysis of cessation outcomes.~   "
180728|NCT01199367|"~     This study will determine the highest dose of KW-2450 in combination with lapatinib and~     letrozole that can be administered safely to subjects with advanced or metastatic breast~     cancer and to evaluate its effectiveness.~      This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.~   "
180729|NCT01199354|"~     The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy~     and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy~     and radiotherapy in invasive breast carcinoma.~   "
180730|NCT01199341|"~     The primary purpose of this study is to determine whether the treatment with AZD1981 affect~     the exposure of Warfarin.~   "
180731|NCT01199328|"~     The purpose of this study is to assess the interaction between aspirin and Nexium in healthy~     volunteers.~   "
180732|NCT01199315|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446~     in young and elderly healthy Japanese volunteers.~   "
180733|NCT01199302|"~     This study is an open label extension of study 20090072 with subjects with Crohn's disease.~     Subjects will receive 350 mg AMG 827 intraveneously every 4 weeks for approximately 2 and a~     half years. The study will be evaluated for safety and efficacy of AMG 827.~   "
180736|NCT01199263|"~     This randomized phase II trial studies the side effects and how well giving paclitaxel with~     or without viral therapy works in treating patients with ovarian epithelial, fallopian tube,~     or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them spreading. Viral therapy may be~     able to kill tumor cells without damaging normal cells. Giving paclitaxel together with viral~     therapy may kill more tumor cells.~   "
180737|NCT01199250|"~     This research study is studying biomarkers in samples from patients with endometrial cancer.~     Studying samples from patients with cancer in the laboratory may help doctors learn more~     about changes that occur in DNA and identify biomarkers related to cancer.~   "
180738|NCT01199237|"~     Protective airway reflexes may be impaired in the postoperative period, creating the~     potential for aspiration of gastric contents, even after a patient exhibits appropriate~     response to command. Because assessment of airway reflex recovery is not possible in an~     intubated patient, the clinician must make an empiric decision as to when a patient is safe~     to extubate, and choose a combination of techniques least likely to result in pharyngeal~     impairment. Adequacy of reversal of neuromuscular block by cholinesterase inhibitors (e.g.,~     neostigmine) is unpredictable, especially in the presence of profound paralysis, and tactile~     assessment of train-of four and sustained tetanus has shown poor correlation with objective~     assessments. Protective airway reflexes may also be impaired during early recovery by the~     anesthetics themselves, even when muscle relaxant has been avoided. In the absence of muscle~     relaxant the investigators previously demonstrated that patients receiving an anesthetic with~     higher tissue solubility, sevoflurane showed significantly greater impairment of swallowing~     up to 14 minutes after response to command compared to patients receiving an anesthetic with~     lower tissue solubility, desflurane. Therefore, we ask whether the combination of the more~     soluble anesthetic and the presence of neuromuscular block antagonized by neostigmine may~     create a multiplicative effect that might further prolong pharyngeal recovery. We plan to~     randomly assign 100 patients scheduled to undergo surgery with general anesthesia to a~     standardized anesthetic that includes 1) sevoflurane, rocuronium with 70 µg/kg neostigmine +~     14 µg/kg glycopyrrolate antagonism (group S); or 2) desflurane, rocuronium with 70 µg/kg~     neostigmine + 14 µg/kg glycopyrrolate antagonism (group D). Airway reflex recovery will be~     judged as adequate by the patient's ability to swallow 20 mL of water without coughing or~     drooling 5, 10, 15, 20, 30 and 60 minutes after response to command. Anesthetic (sevoflurane~     or desflurane) will be discontinued after administration of reversal agent and recovery to~     TOF (train-of-four) ratio of 0.7.~   "
180739|NCT01199224|"~     Compare the bioavailability of three veliparib formulations in subjects with solid tumors.~   "
180740|NCT01199211|"~     Prospective study on the structural and functional changes in the heart of adult women~     assessed by echocardiogram and in lipid metabolism that occur in response to physical~     training. Using echocardiogram we will characterize the early determinants of athletic~     remodeling. We will also assess the effect of intense physical training on lipid metabolism,~     focus on HDL subspecies and function.~   "
180741|NCT01199198|"~     The goal of this clinical research study is to learn if tolvaptan can help raise salt~     (sodium) levels in the cancer patients' blood by removing extra body water as urine.~   "
180742|NCT01199185|"~     Obesity represents a chronic disease associated with significant cardiovascular disease (CVD)~     morbidity and mortality. Weight gain in young adults adversely impacts the development of CVD~     risk factors. Further, there is a clear relationship between weight loss in obese persons and~     reduction in these CVD risk factors. Unfortunately, young adults are at high risk for weight~     gain. Although the scientific literature contains a number of reports regarding successful~     weight loss efficacy studies, young adults are typically underrepresented.~      Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting~     smoking frequently results in significant weight gain. Proactive tobacco quit lines using~     behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT)~     have been shown to help persons quit smoking. However, concerns about post-cessation weight~     gain have been reported as a significant barrier to quitting for many smokers particularly~     young adults.~      If an efficacious behavioral weight loss program could be combined with an efficacious~     behavioral smoking cessation program that prevented or significantly attenuated~     post-cessation weight gain, then a large public health benefit may result. Such a combined~     weight loss/ weight gain prevention / smoking cessation program that used targeted~     intervention strategies to young adults, removed barriers to participation, and utilize~     interactive technology should be appealing to this age group. To date such a combined program~     has not been tested in young adult cigarette smokers. Therefore, the objective of this~     clinical trial is to develop and test a behavioral weight loss / weight gain prevention~     intervention delivered through interactive technology that can be used in conjunction with an~     efficacious tobacco quit line. A total of 330 participants will be necessary to adequately~     address the following specific aims.~   "
180743|NCT01199172|"~     The proposed series addresses the prevention and treatment of voice problems in teachers.~     Data in the literature clearly identify voice disorders as teachers' primary occupational~     risk not only in the U.S. but also internationally. Moreover, voice problems constitute a~     global women's health concern. Until recently, few reports have been available around the~     treatment of these problems in teachers, and even fewer have addressed the equally important~     question of prevention. The present studies are conducted within the context of a long-range~     goal to identify effective intervention methodologies for both the prevention and treatment~     of voice problems in teachers taking into consideration multicultural and linguistic factors.~     The present studies will report pragmatic data around the effectiveness of two~     theoretically-driven approaches to the prevention and treatment of voice problems in~     teachers, (a) voice hygiene education (VH) and (b) voice hygiene education + voice production~     training in resonant voice (VH+VP, essentially the Lessac-Madsen Resonant Voice Therapy~     program). Participants will be student teachers in Pittsburgh and Hong Kong, who will be~     followed from student teaching across their second full year of employment as a professional~     teacher. The central aims are: [1] to evaluate the effectiveness of VH and VH+VP for the~     prevention of future voice problems in student teachers who are vocally healthy at the outset~     of the protocol, versus the treatment of voice problems in student teachers who already have~     them at some level; [2] to evaluate the generality of the findings across teachers in the~     U.S. and China, using appropriate linguistic and cultural adaptations of the interventions;~     and [3] to evaluate the feasibility of an internet-based voice exercise and reporting program~     as a supplement to face-to-face interventions. Ergonomic and personal factors will also be~     evaluated for their differential ability to predict the risk for future voice problems in~     teachers. The results should be useful at a practical level, and should also lay the~     groundwork for future studies assessing similar issues around the prevention of voice~     problems in teachers, in particular as influenced by multicultural factors within the U.S.~     The results should also be useful for future studies investigating causal pathways in~     interventions around these problems.~   "
180744|NCT01199159|"~     Total abdominal hysterectomy is known to be associated with operative blood loss, which can~     lead to patients' morbidity. Misoprostol, a prostaglandin, has been shown to be effective in~     reducing operative blood loss during myomectomy. It is the first study to investigate if~     preoperative misoprostol is effective in reducing operative blood loss during total abdominal~     hysterectomy.~   "
180745|NCT01199146|"~     This is a phase II, open label, single center study to evaluate the efficacy of abiraterone~     acetate (CB7630) administered to patients with castrate resistant prostate cancer who have~     experienced disease progression on ketoconazole.~      It is hypothesized that abiraterone will be active in patients who have experienced disease~     progression on ketoconazole~   "
180746|NCT01199133|"~     The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy~     (SLIT) administered to children and adolescents as allergen-based tablets once daily over a~     period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis~     symptoms and rescue medication use.~   "
180747|NCT01199120|"~     Adequate nutrition is one of the critical biological processes to learning and cognitive~     development of children. And is understandable that malnourishment affect these processes.~     Moreover, in recent decades it has been investigated the beneficial effects of Omega-3 in~     cognitive development and academic performance. However, studies have been limited. Therefore~     is of interest to know the effects that has supplement with Omega-3 for children 8-12 years~     with malnutrition in a randomized, blind, placebo-controlled.~   "
180748|NCT01199107|"~     The purpose of this study is to examine the efficacy of exercise in comparison to wellness~     education to determine if they can improve the effects of prolonged exposure therapy (PE) in~     reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In~     addition, the two strategies (i.e., exercise and wellness education) will be compared in~     terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF).~     BDNF is a protein that helps to support the survival of existing neurons and stimulate the~     growth new neurons and synapses. BDNF is important to learning and memory in general and~     therefore may be associated with the learning and memory as it relates to PE and~     corresponding symptom PTSD improvement.~   "
180749|NCT01199094|"~     The aim of the study is to describe patients with a high bone mass phenotype due to a~     mutation in the low density lipoprotein l receptor 5 gene (LRP5) and compare them with age~     and sex matched controls. Moreover, bone density and microarchitecture as well as markers of~     bone metabolism are evaluated~   "
180750|NCT01199081|"~     Primary Objective:~      - Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to~     different timings of Dronedarone initiation.~      Secondary Objective:~        -  Explore potential PK interaction between Dronedarone and Amiodarone~        -  Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from~          randomization up to 60 days after)~        -  To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety~   "
180751|NCT01199068|"~     The primary objectives of this study are to evaluate the safety and tolerability of CS-7017~     administered orally twice a day in combination with erlotinib, and to assess the~     pharmacokinetics of CS-7017 in combination with erlotinib.~   "
180752|NCT01199055|"~     The primary objectives of this study are to evaluate the safety and tolerability of CS-7017~     administered orally twice a day in combination with carboplatin and paclitaxel, and to assess~     the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.~   "
180753|NCT01199042|"~     Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab~     polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter~     Cheyne Stokes Respiration, or Complex Sleep Apnea.~   "
180754|NCT01199029|"~     This study will investigate the effect of a single dose of PF-04308515 or prednisone on~     calculated measures of glucose tolerance and insulin resistance by using a modified oral~     glucose tolerance test.~   "
180755|NCT01199016|"~     Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective~     against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.~     It is expected that the effectiveness of Prevnar 13 against ear infections in children will~     be similar to that observed following Prevnar. Pfizer has committed to conduct a~     postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.~   "
180756|NCT01198990|"~     The goal of this study is to translate basic behavioral and social science discoveries into~     effective behavioral interventions that reduce obesity and obesity related morbidity in Black~     and Latino communities. This intervention will focus on promoting small changes in eating~     behavior and increasing physical activity among Black and Latino participants in Harlem and~     the South Bronx. The desired result from these activities is individual weight loss that will~     be sustained years after participation in the study.~   "
180757|NCT01198977|"~     This is a clinical trial examining a brief motivational intervention to improve adherence to~     exercise among individuals with MS to improve fatigue.~   "
180758|NCT01198964|"~     We will observe epileptic patients who already have electrodes implanted on the brain and are~     receiving high-level brain stimulation for clinical purposes while testing their motor and~     language function. We propose to do a limited, low-level brain stimulation to show that the~     signatures of local activity in the target area change as an effect of brain stimulation. The~     goal of this study is to understand the feasibility of a novel recurrent brain-computer~     interface that could eventually promote targeted functional recovery in subjects who have had~     a brain injury.~   "
180759|NCT01198938|"~     The investigators plan to evaluate the effect of postoperative melatonin administration on~     postoperative delirium in patients undergoing vascular and cardiac surgery. A total of 302~     patients older than 60, undergoing elective vascular surgery will be randomly divided into 2~     groups: treatment and control. During the first 5 postoperative days patients will receive~     sublingually either melatonin 5 mg or placebo at 9:00 pm. The patients will be assessed for~     the signs of delirium, quality of sleep and severity of pain daily for the first~     postoperative week. Screening of delirium will be performed by the specially trained research~     assistant and based on the Confusion Assessment Method and the validated chart review.~     Diagnosis of delirium will be confirmed by the psychiatrist. Incidence of delirium will be~     compared between the groups.~   "
180760|NCT01198925|"~     Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and~     is frequently used in the empirical treatment of hospital-acquired infections because of its~     antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam~     exhibits time-dependent killing and the T > MIC appears to be the best outcome predictor.~     Because a majority of infections are treated empirically, it is necessary to achieve a T >~     MIC equal to 50% of the dosing interval (50% T > MIC) against the most likely pathogens,~     including those with only moderate susceptibility The aim of this study is to compare the~     same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous~     infusion. A pharmacokinetic study will be performed in patients treated by extended (loading~     dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min~     followed by 16G /24h).~      A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine~     95% probability of target attainment (PTA95) versus MIC~   "
180761|NCT01198912|"~     This is a randomized, double blind, placebo controlled, parallel group, study in patients~     with chronic rhinosinusitis with or without nasal polyps. The objective is to test the~     clinical efficacy of long-term low dose oral doxycycline on wound healing quality after~     endoscopic sinus surgery.~   "
180762|NCT01198899|"~     The purpose of this study is to determine the prevalence of Fabry mutations in patients with~     left ventricular hypertrophy (moderate to severe), as measured by echocardiography.This study~     is a screening study~   "
180805|NCT01198340|"~     To evaluate an analgesic effect without basal administration of local anesthetics for~     patient-controlled femoral nerve block (with sciatic nerve block) after total knee~     arthroplasty.~   "
180763|NCT01198886|"~     The primary objective of this study is to evaluate changes in functional status that result~     from an Exercise-Nutrition Program (ENP) targeted toward older adults residing at senior~     housing facilities.~      - The primary hypothesis is that over the 6-month intervention period subjects in the~     intervention group will realize significant improvements in lower extremity function compared~     to a control group.~      Secondary objectives~      To evaluate changes in nutritional status that result from the ENP.~      - The secondary hypothesis is that subjects in the intervention group will realize~     significant increases in circulating insulin-like growth factor-1 (IGF-1) and 25-hydroxy~     vitamin D (25(OH)D) and demonstrate improvements in nutritional status compared to a control~     group.~      To evaluate changes in inflammatory status that result from the ENP.~      - Subjects in the ENP group will exhibit reduced concentrations of circulating interleukin-6~     (IL-6) compared with the control group.~      To evaluate changes in psychosocial factors that result from the ENP~        -  The related hypothesis is that over the 6-month intervention period subjects in the~          intervention group will increase exercise self-efficacy, intrinsic motivation to~          exercise, and satisfaction of psychological needs compared to a control group.~        -  Additionally it is hypothesized that subjects in the intervention group will realize~          improvements in mood and quality of life compared to a control group.~      To assess the feasibility of conducting the Exercise-Nutrition Program in a senior housing~     facility setting.~   "
180764|NCT01198873|"~     Primary Objective:~      - Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the~     progression of adverse left atrial remodeling in patients with atrial fibrillation (AF)~     following 12 months of treatment.~      Secondary Objectives:~        -  Evaluate the effects of dronedarone versus placebo on left atrial function;~        -  Evaluate the effects of dronedarone versus placebo on left atrial dimension;~        -  Evaluate the effects of dronedarone versus placebo on left ventricular function (LVEF,~          E, E', A, E/E')~        -  Evaluate the safety and tolerability of dronedarone.~   "
180765|NCT01198860|"~     Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid combination~     plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs~     derived from natural and artificial medicaments.~      Has stronger effect on immune system, effective good against HBV replication. This is a~     substantial new insight into the pathogenesis of disease, with a clear path toward clinical~     application, or which would lead to a substantial advance and perfect in management or public~     health policy.~   "
180766|NCT01198847|"~     To study whether a targeted intervention can prevent the development of overweight and~     obesity among pre-school children in families with either one obese or two overweight~     parents.~   "
180767|NCT01198834|"~     A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase~     III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine~     Topical Patch in the Treatment of Ankle Sprains~   "
180768|NCT01198821|"~     The purpose of this study is to:~      Find out the largest dose of sodium bicarbonate that can be given with gemcitabine.~      Determine if the combination of sodium bicarbonate and gemcitabine produces better control of~     pancreatic cancer than gemcitabine alone.~   "
180769|NCT01198808|"~     Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators will~     characterize 40 patients with muscle-invasive bladder cancer regarding the existence and~     frequency of tumorspecific T-cells and regulatory T cells. The found data will be correlated~     to clinical data such as the cancer-specific survival and the response to chemotherapy.~      It is hypothesized that those patients with a high number of Tregs and no tumor-specific~     T-cells have a worse prognosis.~   "
180770|NCT01198795|"~     This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in~     children 7 to 11 years of age with major depressive disorder (MDD).~   "
180771|NCT01198782|"~     The purpose of this study is to evaluate the safety and efficacy of FID 112903 given as an~     immediate treatment replacement in dry eye subjects that discontinue at least 6 months use of~     RESTASIS.~   "
180772|NCT01198769|"~     The purpose of this study is to assess immunogenicity and safety of Rotarix TM when~     administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first~     vaccination) who received Hepatitis B immunoglobulin after birth.~   "
180773|NCT01198756|"~     This study is designed to test the immunogenicity and safety of an investigational influenza~     vaccine, in children compared to two other influenza vaccines.~   "
180774|NCT01198743|"~     Cancer is a DNA disease characterized by the presence of genetics alterations in cancer~     cells.~      The recent studies underline that these recurring alterations must be considered as a good~     molecular marker. In fact, they could use for tumor DNA detection in different biological~     fluids.~      So, the main purpose is to define the presence of circulating tumor DNA in the patients~     plasma with colorectal cancer, by the presence of mutation (KRAS, NRAS, BRAF, APC, TP53 and~     MIRCOSATELLIE instability).~      These molecular analysis will be done both in tumor and plasma samples,~      This trial allows to characterize the prognostic value of circulating tumoral DNA presence in~     colorectal cancer.~   "
180775|NCT01198730|"~     To determine the glucose regulation status of patients who were suspected to have CAD in~     central Taiwan.~   "
180776|NCT01198717|"~     The aim of this study is to evaluate the progression of ET in children (aged 6-17years~     inclusive) over a period of 5 years maximum. The study will also assess how children are~     diagnosed, treatment options for those children with symptoms and events related to their ET~     and the outcomes of those treatments.~   "
180777|NCT01198704|"~     Results of liver transplantation, the best theoretical treatment for HCC, are limited by~     tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However,~     these criteria are to restrictive and approximately 40% of patients denied by Milan criteria~     may be cured by liver transplantation.~      The purpose of this study was thus to prospectively evaluate factors predicting tumor~     recurrence after liver transplantation for HCC and then to reassess criteria for liver~     transplantation.~   "
180778|NCT01198691|"~     The purpose of the study is to compare post operative pain, cost effectiveness, speed of~     closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples~     versus absorbable staples (Insorb) after Cesarean Delivery.~   "
180779|NCT01198678|"~     Currently marketed CGM sensors have an approved functional lifetime of up to 1 week.~     Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to~     accurately monitor glucose levels for 30 days. The purpose of this study is to assess the~     safety and functionality of the device in human patients for consecutive 15 days.~      GluSense-LTone 2e3 as long term CGM, will require less sensor replacements and calibration,~     meaning less patient interventions, and is therefore will be much more user friendly.~     Moreover, GluSense-LTone 2e3 shows potentially increased accuracy, especially in the~     critically important hypoglycemic range, meaning that better management of patient's~     condition may be attained.~   "
180780|NCT01198665|"~     The urgent need for new effective therapy for T-cell lymphoma patients and promising results~     observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the~     investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell~     lymphoma patients.~      Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy~     for newly diagnosed peripheral T-cell lymphoma patients.~      Phase I~        1. Primary objective~           : To define the maximum tolerable dose~        2. Secondary objective~             -  To evaluate the dose-limiting toxicity~             -  To evaluate the pharmacokinetics of RAD001~             -  Pharmacogenomic profiling~      Phase II~        1. Primary objective~           : To evaluate the overall response rate~        2. Secondary objective~             -  To estimate the time to progression~             -  To estimate overall survival~             -  Pharmacogenomic profiling~   "
180781|NCT01198652|"~     This is an open, post-marketing surveillance study obtaining data retrospectively on 300~     women, of any age, treated with the BD-OTS for postpartum uterine bleeding.~   "
180782|NCT01198639|"~     A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than~     45) and death within 1 yr after surgery has previously been reported. In order to confirm or~     refute these findings, the investigators have designed a study which compares two methods of~     administration for total intravenous anesthesia (propofol and remifentanil):~        -  manual administration: the anesthesiologists are instructed to maintain the BIS value~          between 40 and 60.~        -  closed loop administration: an algorithm is used to maintain the BIS value between 40~          and 60.~      Based on previous studies, the amount of time that BIS is maintained above 40 is greater when~     anesthetics agents are administered using closed loop compared with manual administration.~   "
180783|NCT01198626|"~     The purpose of this study is to determine the efficacy, safety and tolerability of~     JNJ-32729463 compared to moxifloxacin for the treatment of subjects requiring hospitalization~     for Community-Acquired Bacterial Pneumonia (CABP).~   "
180784|NCT01198613|"~     It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with~     ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic,~     allergen-derived peptide desensitising vaccine, currently being developed for the treatment~     of ragweed allergy.~      This study will look at the efficacy, safety and tolerability of two doses of ToleroMune~     Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.~   "
180785|NCT01198600|"~     The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear~     and how those factors affect contact lens replacement frequency.~   "
180786|NCT01198587|"~     Diarrheal diseases are the third leading cause of mortality in the world, with nearly 2~     million deaths annually among children under age 5 years. Several clinical trials of oral~     zinc supplementation performed in developing country populations have confirmed this~     nutrient's efficacy in reducing the severity and frequency of diarrhea. The World Health~     Organization (WHO) has recommended global use of zinc supplementation in all children with~     diarrhea despite little or no data from trials in industrialized/developed settings. In the~     United States over 4 million children suffer annually from diarrheal illness. Although~     mortality is not a significant factor in U.S. cases, 75% of all cases present to medical care~     resulting in over 200,000 hospitalizations annually for diarrhea. This has significant impact~     on U.S. healthcare costs, with an average of $391 per outpatient treatment and $2,549 per~     inpatient treatment spent on each episode of acute diarrheal illness. The goal of this study~     is to evaluate the effectiveness of oral zinc in decreasing the duration of diarrhea in~     children treated as outpatients and in decreasing the duration of hospitalization in children~     treated as inpatients in an industrialized country. The results of this study promise to have~     a substantial impact on the management of a common pediatric health problem, and could~     conceivably affect direct and indirect healthcare costs to society.~   "
180787|NCT01198574|"~     Anemia and vitamin A deficiency (VAD) are major nutritional problems in the world and also in~     Myanmar. Both nutrient deficiencies result from interaction of several causal factors, and a~     better understanding of the etiology to interpret the prevalence and to formulate appropriate~     measures to reduce these deficiencies is necessary. There is a growing concern on the role of~     sub-clinical inflammation on the nutritional status indicators during the nutritional status~     assessment. However, there is lack of information on the role of inflammation on the iron~     supplementation. The adolescent period is a window of opportunity to improve the~     preconceptional iron status of the girls and recently gained much attention. The purpose of~     the study is to understand the role of inflammation on iron and vitamin A status during iron~     and vitamin A supplementation. The findings will show the extent to which iron~     supplementation has been hampered by inflammation and to formulate the necessary measures to~     overcome the interference.~   "
180788|NCT01198561|"~     The objective of this study is to investigate the antidepressant efficacy of rTMS, and to~     assess cortical metabolism before and after rTMS sessions in patients with major depression.~     We also aimed to investigate differences between the responders and nonresponders to rTMS and~     what would predict clinical response to rTMS.~   "
180799|NCT01198418|"~     This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more~     information about the methods that are used on the internet to provide information on how to~     reduce the risk of giving or getting infections that are often or usually passed from one~     person to another during sexual or intimate contact (sexually transmitted infection (STI)).~     STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop~     methods that will allow someone who is living with HIV an easy way that they can get~     information and learn of ways on their own that can decrease their chances of getting~     sexually transmitted infections and ways that they can reduce the chance that they may~     transmit HIV to others.~   "
180789|NCT01198548|"~     This phase II trial is studying how well giving high-dose cholecalciferol works in treating~     patients receiving combination chemotherapy and bevacizumab as first-line therapy for~     metastatic colorectal cancer. Cholecalciferol during treatment may delay the development of~     colorectal cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Giving cholecalciferol together with combination chemotherapy and monoclonal antibody therapy~     may be an effective treatment for colorectal cancer~   "
180790|NCT01198535|"~     The purpose of this study is to determine if a new drug, RO4929097, can work with cetuximab,~     a drug already approved for colorectal cancer, to help fight the patient's cancer. Cancers~     arise as a result of abnormal control of gene expression. One of the pathways that gets~     abnormally regulated in some cancers is the Notch pathway. RO4929097 is an investigational~     drug that blocks the activation of the Notch pathway. It is hoped that by blocking this~     abnormal activation, this drug may be helpful in patients with cancer but the investigators~     do not yet know if that is true. Cetuximab is an antibody against epidermal growth factor~     receptor and is known to have activity in metastatic colorectal cancer. Recent studies have~     shown that people with colorectal cancers that contain a mutation in a gene called K-ras do~     not benefit from receiving cetuximab. It is unknown if adding RO4929097 to cetuximab would~     benefit patients who have tumors with this mutation.~   "
180791|NCT01198522|"~     Systemic treatment for advanced, non-resectable pancreatic cancer still having minimal impact~     on the survival of patients. Even with the application of more potent gemcitabine-based~     regimens, survival of more than 1 year is uncommon for advanced disease. Accordingly, there~     is substantial unmet needs for the improvement of treatment options. The combination and~     simultaneous application of tumor-targeted L19IL2 with gemcitabine could result in improved~     anti-cancer efficacy, based on preliminary clinical and strong preclinical data.~      The primary purpose of this Phase I study is to define a safe and potentially more active~     treatment regimen of L19IL2 (escalating doses) combined with gemcitabine for advanced~     pancreatic cancer patients. Also, early signs of anticancer responses of the~     L19IL2/gemcitabine regimen will be assessed and compared to historical controls (gemcitabine~     monotherapy).~   "
180792|NCT01198509|"~     Rheumatoid arthritis (RA) is an inflammatory form of arthritis that causes joint pain and~     damage. RA attacks the lining of the joints (synovium), causing swelling that can result in~     aching and throbbing, and eventually deformity. Even though there have been many advances in~     the treatment of RA, psoriatic arthritis (PsA), and other inflammatory arthritis, doctors~     still do not know what causes this inflammation in joints. It is likely that RA occurs as a~     result of a complex combination of factors, including a person's genes; lifestyle choices,~     such as smoking and diet; and things in a person's environment, including bacteria or~     viruses. This study investigates the hypothesis that bacteria living in a person's mouth~     and/or intestinal tract are responsible, at least in part, for the development of Rheumatoid~     Arthritis. The investigators believe that by killing those bacteria with antibiotics, they~     might be able to understand how the immune system works and, maybe, what causes RA.~   "
180793|NCT01198496|"~     1. Objectives and Hypothesis~             1. Objectives:~                This study evaluates whether strict BP management is useful for the prevention of~               recurrent stroke.~                Hypertensive patients with history of stroke are treated with stepwise multi-drug~               therapy to achieve stricter BP target <120/80 mmHg in the strict BP control group~               and less stricter BP target <140/90 mmHg or <130/80 mmHg for patients with current~               DM/CKD/MI in the standard BP control group. The participants under the BP treatment~               achieving their respective BP target will be followed for recurrence of stroke. The~               study continues until the number of patients with the first recurrent stroke~               reaches a total of 330 between the two groups. The occurrence rates of recurrent~               stroke will be compared between the two groups.~             2. Hypotheses The incidence of recurrent stroke will be lower in a strict BP control~               group having lower BP target: <120/80 mmHg* than in a standard BP control group~               having BP target <140/90 mmHg or <130/80 mmHg for current DM/CKD/MI in patients~               with hypertension.~        2. Study design This will be a multicenter, randomized, open-label study. The study~          consists of a screening period, a titration period and a follow-up period. The screening~          period is a period between the date of consent and the enrollment date. Hypertensive~          patients with history of stroke are randomly assigned to either the strict BP control~          group having the target of <120/80 mmHg or the standard BP control group having the~          target of <140/90 mmHg without current DM, CKD or MI and <130/80 mmHg with current DM,~          CKD or MI. The titration period is the period finding a treatment which achieves target~          BP, and 24 weeks at maximum. Patients will be treated with stepwise multi-drug therapy~          using an angiotensin-receptor antagonist, diuretic, calcium channel blocker and~          aldosterone antagonist. The participants will be observed under the BP management for~          their respective BP target. The study will be continued until the number of patients~          with the first recurrent stroke reaches a total of 330 between two groups. The follow-up~          period will be 3 years.~      The recurrent rates of stroke in both groups will be compared from various aspects, and~     strict BP management will be investigated on the usefulness in prevention of recurrent~     stroke.~   "
180794|NCT01198483|"~     The purpose of this study is to compare refractive outcomes after two different types of~     combined cataract surgery, namely microinscision cataract surgery and smallincision cataract~     surgery, and sutureless 23-gauge vitrectomy in patients presenting with vitreoretinal~     disorders and coexisting cataracts.~   "
180795|NCT01198470|"~     The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH®~     Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc~     Disease (DDD) at one level from L1 to S1.~   "
180796|NCT01198457|"~     Adherence (or compliance with) a medication regimen is generally defined as the extent to~     which patients take medication as prescribed by their health care providers. The adherence to~     medications has close relation to effectiveness of the therapy. The primary objective of this~     study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days~     covered, number of days in which clodronate is taken according to treating physician~     recommendation) in patients with malignancy. The secondary hypothesis generating objective~     is to describe the relation between adherence to treatment with oral clodronate and efficacy~     of the therapy (skeletal events, pain).~   "
180797|NCT01198444|"~     Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives~     efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral~     treatment. The aim of the study is to evaluate in everyday practice the relation between~     dosage errors and indicated factors, potentially influencing the compliance with the dosing~     scheme.~   "
180798|NCT01198431|"~     The main aim of this study is to examine the effects of restricted sleep on energy and~     substrate metabolism as well as relevant hormonal systems that might be involved in the~     underlying mechanisms.~      The investigators hypothesize that short-term sleep curtailment in adolescents is accompanied~     by 1) increased hunger and desire to eat; 2) increased spontaneous energy intake; 3) reduced~     spontaneous physical activity; and 4) increased fluctuation in hormones in a way that could~     favour a positive energy balance and potentially weight gain on the long run.~   "
180807|NCT01198314|"~     Long-term immunosuppression carries potential adverse effects such as risk of infection,~     malignancy, renal insufficiency, diabetes and hypertension. In clinical liver~     transplantation, some liver transplant recipients maintain allograft function without~     immunosuppressive drugs. This is called as operational tolerance. Many attempts have been~     made to identify immunological biomarkers predicting operational tolerant patients.~     Therefore, the investigators aimed to identify patients who have the potential to be~     operationally tolerant using biomarkers, withdraw immunosuppressant gradually and stop~     ultimately with monitoring of biomarkers.~   "
180808|NCT01198301|"~     The investigators want to develop a gene expression profile the for prediction the~     chemotherapeutic response of patients with metastatic breast cancer.~   "
180809|NCT01198288|"~     This study will investigate if adding a domiciliary respiratory physiotherapy treatment to~     standard care in patients with chronic obstructive pulmonary disease (COPD) can improve~     physical function (walking test) and quality of life.~   "
180810|NCT01198275|"~     The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone~     and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm~     after electrical conversion in patients with persistent Atrial fibrillation (AF).~   "
180811|NCT01198262|"~     The purpose of this study is to determine whether the Cepheid GeneXpert system accurately~     detects Methicillin-Resistant and -Susceptible Staphylococcus aureus in blood cultures and~     wound swabs.~   "
180812|NCT01198249|"~     This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among~     anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study~     provides useful information to develop a new fixed dose combination drug.~   "
180813|NCT01198236|"~     Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients~     receiving chemotherapy for leukemia, or submitted to stem cell transplantation. Patients with~     a history of invasive fungal infection (IFI) are at high risk of developing relapse and fatal~     complications.~      Prompt intensive antifungal therapy, have improved responses and survival, allowing an~     increase of antifungal treatments, including secondary antifungal prophylaxis.~      Few studies have addressed the role of previous IFI in the feasibility of stem cell~     transplant, or the secondary prophylaxis with antifungal drugs in preventing recurrence of~     infection after transplantation. However, given the lack of prospective studies, the role of~     secondary antifungal prophylaxis remains unclear.~      Itraconazole is a wide-spectrum triazole antifungal agent active against Candida albicans,~     non-albicans, Aspergillus spp., Blastomyces dermatitidis, Blastomyces coccidioides,~     Cryptococcus neoformans, Sporothrix schenkii, Paracoccidioides brasiliensis, Histoplasma spp.~     and various kinds of yeast fungi and mycetes.~      The role of itraconazole IFI prophylaxis treatment has been proved by many interventional~     studies. In this prospective, multicentric study of secondary prophylaxis, itraconazole will~     be given at standard dose to patients undergoing allogeneic stem cell transplantation or~     chemotherapy with prior invasive fungal infection, to assess the efficacy and safety of~     itraconazole secondary prophylaxis.~   "
180814|NCT01198223|"~     The aim of the present study was to compare the effect of aqueous extract of garlic with~     nystatin mouthwash in denture stomatitis.~   "
180815|NCT01198210|"~     The immediate postoperative period after tonsillectomy, , is often difficult. These children~     frequently have severe pain but postoperative airway edema along with increased sensitivity~     to the respiratory-depressant effects of opioids may result in obstructive symptoms and~     hypoxemia. Opioid consumption may be reduced by non-steroidal anti-inflammatory drugs, but~     these drugs may be associated with increased bleeding after this operation.~      Methods: One hundred sixty ASA I-II children 3-12 were randomized four groups of 40 each.~     Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2~     mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg~     dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil~     3 min prior to tonsillectomy. Study drugs were marked only with a coded number label. A~     computer-generated table of numbers guided randomization. Modified Hannallah pain scale~     [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation and~     Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients were~     interviewed on the day after surgery to assess the postoperative pain, nightmares,~     hallucinations, vomiting and bleeding. All the children were premedicated with midazolam~     hydrochloride 0.3 mg/kg) and fentanyl 1micro g/kg intavenously. Anesthesia was induced with~     thiopental 5mg/kg and atracurium0.3mg/kg. Anesthesia was maintained with isoflurane 1.5% and~     nitrous oxide 30% in oxygen. The two surgeon used the same dissection and snare technique for~     all cases and hemostasis done with bipolar cutter. At the end of the surgery neuromuscular~     blockade was reversed by neostigmine 0.03 mg/kg) and atropine 0.01 mg/kg intravenously),~     anesthesia was discontinued and the tracheal tube removed in the operating room when patients~     were deep. After extubation the patients were taken to the postanesthesia care unit (PACU)~     where an nurse who were unaware of the study drug observed the patients. The pain scoring~     observer nurse in PACU was consistent. Time to awaken (from the end of anesthesia until the~     patients opened their eyes on command) and time to the first administration of postoperative~     analgesia were recorded. Pethidine in a titrated dose (total 1 mg/kg) was administered~     intravenously for rapid pain relief to patients with a OPS score > 4 or who were crying~     during two consecutive five minute observation periods until the child was comfortable.~     Postoperative pain during the first 24 h was assessed using a four-point scale: 0 no pain, 1~     mild pain, 2 moderate pain, 3 severe pain by questioning their parents. In the ward the~     standardized postoperative analgesic technique was with acetaminophen supp (40 mg/kg followed~     by three doses of 20 mg/kg at 6-hour intervals to be given as needed for pain. Pethidine in a~     titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to~     patients who had pain scale >3.Any supplementary analgesia , nausea and vomiting, bleeding,~     sleep disturbance and nightmares that the child might have had as surgery were assessed~     during a telephone follow up 24 h later.~   "
180816|NCT01198197|"~     Background:~      - A small brain protein called nociceptin/orphanin FQ peptide (NOP) receptor may be involved~     in several brain diseases such as anxiety, depression, drug abuse, and seizures. Researchers~     are interested in testing a new radioactive chemical that will help locate NOP receptors in~     the brain during imaging studies such as positron emission tomography (PET) scans. Because~     this chemical has not yet been approved by the Food and Drug Administration, it is considered~     to be an experimental drug.~      Objectives:~      - To investigate the effectiveness of the experimental chemical [11C]NOP-1A in imaging~     studies of the nociceptin/orphanin FQ peptide (NOP) receptor.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age who are able to have imaging studies.~      Design:~        -  This study will involve three or four outpatient visits to the National Institutes of~          Health Clinical Center. All participants will be screened with a full physical~          examination, medical history, blood and urine tests, and electrocardiogram.~        -  Participants will be involved in one or more parts of this three-part study as directed~          by study researchers. Part 1 consists of brain imaging to study how the brain responds~          to the chemical. Part 2 is a whole body imaging study to evaluate how the chemical is~          distributed throughout the body after being administered. Part 3 is a set of testing and~          retesting scans to determine how precise the drug is in locating the NOP receptors in~          the brain.~        -  Part 1: Participants will have a brain magnetic resonance imaging (MRI) scan. Then the~          study drug will be administered and participants will have a brain PET scan. Blood~          samples will be taken during the PET scan, and urine samples will be taken after the~          scan. These tests will take up to 3 hours to perform.~        -  Part 2: Participants will have a whole body PET scan that will last a maximum of 3~          hours.~        -  Part 3: Participants will receive the study drug and have two additional PET scans.~          Blood samples will also be taken during this part.~   "
180817|NCT01198184|"~     This phase I trial is studying the side effects and best dose of giving gamma-secretase/Notch~     signalling pathway inhibitor RO4929097 and temsirolimus together in treating patients with~     advanced solid tumors. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 and~     temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
180818|NCT01198171|"~     This research study is studying racial and genetic biomarkers of response in tissue samples~     from patients with endometrial cancer. Studying samples of tissue from patients with cancer~     in the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. DNA analysis of tumor tissue may also help doctors predict how~     well patients will respond to treatment.~   "
180819|NCT01198158|"~     This randomized phase III trial studies giving everolimus together with bevacizumab to see~     how well it works compared to everolimus alone in treating patients with advanced kidney~     cancer that progressed after first-line therapy. Everolimus may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     bevacizumab, can interfere with tumor growth by blocking the ability of tumor cells to grow~     and spread. Everolimus and bevacizumab may also stop the growth of kidney cancer by blocking~     blood flow to the tumor. It is not yet known whether giving everolimus together with~     bevacizumab is better than everolimus alone in treating patients with advanced kidney cancer~     that has progressed after first-line therapy.~   "
180820|NCT01198145|"~     RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing~     pelvic radiation therapy.~      PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works~     in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation~     therapy.~   "
180848|NCT01197755|"~     The purpose of the study is to evaluate the effectiveness of two dosing regimens of~     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking~     methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study~     will last for approximately six months.~   "
180821|NCT01198132|"~     The aim of this multicentre, randomised, double-blind, placebo-controlled study is to~     evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin D3)~     in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.)~     interferon beta-1a 44 microgram (mcg) [Rebif] 3 times weekly. The subjects will be divided~     into 2 groups, one receiving cholecalciferol 100,000 IU twice monthly along with Rebif~     treatment and the other group will be on placebo along with Rebif treatment. A total of 200~     subjects will be recruited in 20-30 centres in France.~   "
180822|NCT01198119|"~     This study evaluates the feasibility of the NBI technique in the detection of early cancer~     lesions.~   "
180823|NCT01198106|"~     BACKGROUND:flight simulator have become an important component in pilot training. However,~     they are known to be associated with motion sickness like symptoms defined as Simulator~     Sickness (SS). Prevention countermeasures against motion sickness have been studied~     extensively focusing on cholinergic blockers and antihistamines. Most comparataive studies~     emphasized the effectiveness of scopolamine over outher agents. Evidence, though, on~     prophylaxis against SS is sparse.~      OBJECTIVE: to assess the effectiveness of oral scopolamine versus oral cinnarizine or placebo~     for SS prevention in helicopter pilots.~      DESIGN: a prospective, placebo controlled double-blind.~      SETTING: Israel Air Forse (IAF) Helicopter Aircaft vWeapon System Trainer.~      PARTICIPANTS: IAF experienced helicopter pilots.~      INTERVENTION: 0.6 mg oral scopolamine or 50 mg oral cinnarizine or placebo 1 hour before~     beginning of a 3 sortie simulator training~   "
180824|NCT01198093|"~     The objective of this study is to present evidence-based medicine for development of clinical~     practice guideline through prospective study of Alzheimer's disease(AD) and mild cognitive~     impairment(MCI) in korea~   "
180825|NCT01198080|"~     Avascular necrosis is a disease where there is cellular death (necrosis) of bone components~     due to interruption of the blood supply. Without blood, the bone tissue dies and the bone~     collapses. If avascular necrosis involves the bones of a joint, it often leads to destruction~     of the joint articular surfaces. Avascular necrosis is especially common in the hip joint. A~     variety of methods are now used to treat avascular necrosis the most common being the total~     hip replacement, or THR.A new, more promising treatment is hip resurfacing or metal on metal~     (MOM) resurfacing.Another treatment is utilization of bone marrow derived stem cells.these~     stem cells can provide angiogenic factors and osteogenic cytokine to improve angiogenesis and~     bone formation.~   "
180826|NCT01198067|"~     The goal of this clinical research study is to find the highest tolerable dose of~     pomalidomide that can be given to patients with relapsed or refractory WM. The safety of this~     drug will also be studied.~      This is an investigational study. Pomalidomide is FDA approved and commercially available for~     the treatment of certain types of MM. Its use in this study is investigational.~      Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.~   "
180827|NCT01198054|"~     The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in~     patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5~     (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for~     those who no obtained response treatment (total resistance) or partial remission.~      At the same time, the study evaluate the security of lenalidomide.~   "
180828|NCT01198028|"~     The goal of this clinical research study is to learn if erlotinib can help to control~     squamous cell carcinoma that has either come back or has spread. The safety of this drug will~     also be studied.~   "
180829|NCT01198015|"~     Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good~     appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The~     pathological mechanism is barely understood. Although feeding difficulties may play a role in~     this, other constitutional factors as altered metabolic processes are suspected. Preliminary~     research showed elevated plasma creatine concentrations and increased urinary~     creatine/creatinine ratios in half of the RTT girls.~      The aim of this study is to confirm previous findings and examine the functionality of the~     creatine transporter in RTT girls.~      The investigators assume that previous findings will be confirmed, and are due to an altered~     functionality of the creatine transporter.~   "
180830|NCT01198002|"~     The primary purpose of this study is to help answer if LY2127399 is safe and effective in the~     treatment of rheumatoid arthritis while on a background treatment of methotrexate.~      This study is comprised of 3 periods:~      Period 1: 52-week blinded treatment~      Period 2: additional 48-week unblinded treatment~      Period 3: 48-week post-treatment follow-up~   "
180831|NCT01197989|"~     The purpose of this study is to evaluate the efficacy of a special sock, manufactured using~     TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar~     pustulosis present for at least one year.~   "
180832|NCT01197976|"~     The purpose of this study is to evaluate the efficacy of a special sock, manufactured using~     TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar~     psoriasis present for at least one year.~   "
180833|NCT01197963|"~     The purpose of the study is to determine if by performing surgery we can cure Type II~     Diabetes.~      The surgical procedures:~        1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction~          of caloric intake and rapid gastric emptying.~        2. ileal transposition which involves repositioning a 150cm segment of the ileum into the~          jejunum causing improved glucose homeostasis.~   "
180834|NCT01197950|"~     The purpose of this study is to evaluate the effect of manual acupuncture and~     electro-acupuncture on labour pain.~   "
180847|NCT01197768|"~     The purpose of this study is to evaluate the efficacy and feasibility of a multi-level~     self-management intervention to improve nutritional intake in a group of homebound older~     adults (HOAs) who are at especially high risk for undernutrition. The study will be guided by~     the theoretical approaches of the Ecological Model and Social Cognitive Theory and will use a~     prospective randomized controlled design to estimate whether individually tailored counseling~     focusing on social and behavioral aspects of eating results in increased caloric intake and~     improved nutrition-related health outcomes in a sample of 104 HOAs. The investigators~     hypothesize that intervention at these levels will improve caloric intake and indirectly~     improve health outcomes.~   "
184189|NCT01153906|"~     The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases~     (AIDs) following females who have received at the least the first dose of Cervarix® as part~     of their routine health care.~   "
180835|NCT01197937|"~     The goal of this observational study is to assess the efficacy of Realize My Success (RMS),a~     website that allows patients and providers to maintain contact via the website. We will~     compare RMS users on a number of different variables with the goal of identifying which~     variables are associated with optimal outcomes (larger weight losses) at one year (and~     potentially beyond). The study has two primary objectives. The first is to assess changes in~     body weight at postoperative year 1 in frequent v. infrequent RMS users. We predict that~     frequent users will achieve significantly greater reductions in weight at 6 and 12 months~     (and beyond) than infrequent users. The second objective is to assess changes in body weight~     at postoperative year 1 in persons who use different features of the RMS site. We hypothesize~     that persons who, on a regular basis, record their food intake, track their physical activity~     and make specific behavioral goals will experience significantly greater reductions in weight~     beginning 6 months after surgery as compared to those who do not use these features of the~     RMS site.~   "
180836|NCT01197924|"~     The medulloblastome is a tumour of the child relatively frequent usually sitting in the~     cerebellum and treated by surgery, radiotherapy and chemotherapy. After the treatment, these~     children present cognitive disorders and in particular disorders of the working memory~     associated with a fall with the school performances. By studying a troop of 32 children, we~     could show that the disorders of the working memory prevail during the handling of~     information presented visually and with verbal contents. However, the specific engagement of~     the cerebellum in the tasks of working memory according to the sensory method of presentation~     (visual or auditive) and the nature (verbal or not verbal) of information to treat vague~     remainder. Moreover, the anatomical attacks associated with these disorders remain ignored in~     these children. The best comprehension of the bases anatomo-functional calculuses which~     underlie their cognitive deficits is essential to develop new strategies of treatment and~     rehabilitation.~      Objectives:~        -  To describe in IRMf of the common and specific networks engaged during the execution of~          the tasks of working memory according to the sensory type and the nature of information~          to be memorized.~        -  To describe in IRMf the cortical reorganizations necessary to the execution of the~          mnemic tasks among patients.~        -  To describe in anatomical IRM and of the tensor of diffusion lesions cérébelleuses and~          cerebral, cortical and subcortical associated with these disorders.~        -  To study the correlations radio-private clinics between data IRM and the data~          neurological and neuropsychological of the children explored according to protocol~          ONCORAP~   "
180837|NCT01197911|"~     This open-label study will assess the effects of hepatic impairment on the pharmacokinetics~     of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment~     (Child-Pugh class A or B) and in matched control subjects with normal hepatic function.~     Subjects will receive a single oral dose of aleglitazar, with assessment of the~     pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled~     subject is approximately 6 weeks.~   "
180838|NCT01197898|"~     The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds~     following 14 days of treatment with Santyl or its vehicle base.~   "
180839|NCT01197885|"~     IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma.~     Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect~     (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct~     mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to~     establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients~     suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower~     esophagus.~   "
180840|NCT01197872|"~     Gene Security Network has developed a novel technology called Parental Support (PS) which is~     used for Preimplantation Genetic Screening/Diagnosis (PGS/D) during in vitro fertilization~     (IVF). This technology allows IVF physicians to identify embryos, prior to transfer to the~     uterus, which have the best chance of developing into healthy children.~   "
180841|NCT01197846|"~     Pilot multicentric, prospective, placebo controlled, randomized double blinded, study of 12~     weeks follow-up Adult patients diagnosed of bipolar disorder I or II, in previous treatment~     with no more than two concomitant mood stabilizers at stable doses and current subsyndromal~     symptoms, defined as YMRS ≤14 and/ or MADRS≥8 and ≤14 would be included Sub-acute phases~     would be excluded (at least 8 weeks from last exacerbation would be required for inclusion).~   "
180842|NCT01197833|"~     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and~     may cause discomfort. In this study, patients with varicose veins in the legs will be~     participating. The purpose of this research study is to evaluate the safety and effectiveness~     of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM)~     compared to vehicle (inactive solution) when used following an approved heat treatment in~     subjects with varicose veins.~   "
180843|NCT01197820|"~     Several technological challenges exist to apply Magnetic Resonance guided High Intensity~     Focused Ultrasound (MRgHIFU) for treatment of liver or kidney in particular challenges~     related to the motion of these organs. This study tests a new software to improve thermometry~     accuracy in mobile organs in patients with liver or kidney tumors. In the same time, the~     trajectory of the target in 3D is analyzed.~   "
180844|NCT01197807|"~     Until recently, bulb or catheter oronasopharyngeal suctioning (ONPS) of all the infants,~     including vigorous infants in the delivery room, has been featured as a standard of newborn~     care. The 5th edition of the Newborn Resuscitation Program (NRP) has minimized the~     recommendation for routine suctioning of infants following delivery, provided they are not~     depressed or in need of immediate resuscitation. However, this new alternative recommendation~     was based on a small randomized trial and other lower level evidence rather than evidence~     from larger trials. The NRP Textbook cautions against vigorous suctioning because of the~     resultant apnea or bradycardia. Furthermore, suctioning may delay other more important steps~     of resuscitation. Thus, it is necessary to compare the alternative recommended practice, i.e.~     simple wiping of the mouth, to determine if it has equivalent efficacy and a favorable side~     effect profile compared to suctioning.~   "
180845|NCT01197794|"~     The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active~     compound in asthmatic patients.~   "
180846|NCT01197781|"~     This Study evaluates the possible drug interaction between FosD and verapamil when taken~     together.~   "
180849|NCT01197742|"~     The Sweetheart register (Risk management of Diabetics with acute myocardial infarction)~     documents both the prevalence of pathologic glucose metabolism in consecutive high-risk~     patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute~     and long-term therapy. Furthermore the register will provide data about the implementation of~     new guidelines for the interventional and adjuvant medical therapy of STEMI and NSTEMI.~   "
180850|NCT01197729|"~     OPTAMI documents the characteristics of consecutive patients with acute STEMI and NSTEMI in~     hospital everyday-life in Germany, their acute and adjuvant medication treatment, events~     until discharge (e.g. mortality, stroke, re-MI), and their medication for secondary~     prevention at discharge.~      In the follow up-period of one year, information is collected concerning events as mortality,~     stroke, re-MI, coronary interventions (PCI, CABG) and re-hospitalisation.~      The implementation of guideline-adjusted therapy in hospital everyday-life is reviewed. The~     usefulness of the European standard for data acquisition in cardiology (CARDS = Cardiology~     Audit and Registration Standards) is evaluated.~   "
180851|NCT01197716|"~     The Chest Pain Unit (CPU) register is a nationwide scientific investigation, in which data~     concerning the hospital-stay within the Chest Pain Unit are documented. Furthermore, a~     Follow-up via telephone is conducted after 3 months.~   "
180852|NCT01197703|"~     The European Cardiac CT Registry has the unique potential to provide important data that will~     help to clarify the clinical role of cardiac computed tomography (CT), to create guidelines~     and recommendations for its use, and to identify the most important areas that require~     specific further research.~   "
180853|NCT01197690|"~     The purpose of this study is to determine mean or median of fractional exhaled nitric oxide~     (FeNO) in Thai atopic asthmatic patients that divided into subgroups due to level of asthma~     control according to the global initiative for asthma guideline.~   "
180854|NCT01197677|"~     1. The main aim of the first specific protocol initiated by the European CMR registry,~          suspected CAD, is to demonstrate that patients presenting for work up of suspected~          coronary artery disease, which have a completely normal CMR scan will have a low risk~          for cardiovascular events.~        2. The main aim of the second specific protocol initiated by the European CMR registry,~          HCM-SCD, will be to evaluate CMR for risk stratification in hypertrophic~          cardiomyopathy(HCM).~        3. This registry is sought to collect data on the general use of CMR in the European~          clinical practice, its safety and its therapeutic implications in a high number of cases~          to 1) substantiate the clinical yield of CMR and 2) to define additional clinical~          questions worth to be investigated in detail as additional specific protocols in the~          future.~   "
180855|NCT01197664|"~     This randomized pilot clinical trial studies the side effects of giving paricalcitol together~     with fluorouracil and radiation therapy in treating patients with rectal cancer that can be~     removed in surgery. Paricalcitol may help rectal cancer cells become more like normal cells,~     and to grow and spread more slowly. Drugs used in chemotherapy, such as fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. It not yet~     known if chemotherapy and radiation therapy are more effective with or without paricalcitol~     in treating rectal cancer~   "
180856|NCT01197651|"~     The aims of the aorta-stent-Registry are:~      • participating hospitals (with audit) document all consecutive patients diagnosed with a~     disease of the distal thoracal aorta that receive one of the following therapies:~   "
180857|NCT01197638|"~     The goal of this register is the documentation of the success as well as of the complications~     regarding interventional therapy of cardiac arrhythmia by catheter ablation. This is the~     necessary basis for quality management and development of possible improvements of catheter~     ablation.~   "
180858|NCT01197625|"~     In this study the investigators will include patients with high risk of PSA relapse scheduled~     to receive curative surgical treatment. This include patients with high Gleason score (9-10)~     or micrometastatic disease (tumor cells detected in specimens obtained from bone marrow).~     They are scheduled for regular follow-ups with PSA measurements. We have previously published~     that some patients with metastatic prostate cancer may respond to DC-vaccination with tumor~     mRNA, with a decrease in PSA. PSA response is related to immunological response. Patients~     receiving DC-vaccination may have a reduced risk of PSA relapse or increased time to PSA~     relapse. Previous experience with different DC-vaccine protocols in our hospital has resulted~     in only minor side-effects (grade 1-2 fever, rubor, fatigue, local swelling or pain).~   "
180859|NCT01197612|"~     That high-dose steroid applied to the nasal cavity immediately post-operatively will improve~     olfaction and healing following endoscopic sinus surgery.~   "
180860|NCT01197599|"~     The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit~     training on the upper extremity of persons with spinal cord injury and able-bodied controls.~   "
180861|NCT01197586|"~     Establishing new biochemical markers in the differential diagnostics and risk stratification~     in heterogeneous patient collectives is becoming more and more important. The markers should~     be objective, reliable, reproducible, quick and cost effective as well as specific and~     sensitive. Concerning the differential diagnostics of dyspnea, NT-pro-BNP plays the most~     important role for the evaluation of a cardiac origin. However, a corresponding biochemical~     marker for pulmonary stress is lacking. The aim of the study at hand therefore was the~     evaluation of surfactant protein B in the differential diagnostics of pulmonary and cardiac~     diseases.~   "
180862|NCT01197573|"~     We hypothesize that delayed graft function and ITBS events may be related to small blood~     clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of~     the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant~     morbidity and mortality, and may ultimately result in a greater number of transplantable~     livers and kidneys.~   "
180863|NCT01197560|"~     The purpose of this study is to compare lenalidomide to a control drug and see which one~     delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.~   "
180906|NCT01197001|"~     Study Design :~        -  A single center, open, randomized, single dose, two-period, two-treatment, two-sequence,~          crossover study~      Primary Objective:~        -  To assess the bioequivalence of combination oral formulation of amlodipine/losartan~          versus two co-administered products containing amlodipine and losartan~   "
180864|NCT01197547|"~     This is a clinical registry of an FDA approved device system called the Genesys Hydro~     ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be~     inserted, by a trained physician, into the uterus, where it will fill and circulate fluid~     that is warm enough to change the characteristics of the uterine lining. This is done with~     the anticipated result of improving menstrual bleeding symptoms.~      The purpose of this FDA-mandated registry is to obtain clinical experience on the use the~     Genesys HTA™ system, under normal clinical conditions, and document its safety and technical~     reliability.~   "
180865|NCT01197534|"~     The purpose of the study is to evaluate the effectiveness of two dosing regimens of~     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking~     disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1~     year.~   "
180866|NCT01197521|"~     The purpose of the study is to evaluate the effectiveness of two dosing regimens of~     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking~     methotrexate but not responding. The study will last for 1 year.~   "
180867|NCT01197508|"~     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a~     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken~     together with another antidepressant.~   "
180868|NCT01197495|"~     The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra~     XC Injectable Gel for lip augmentation~   "
180869|NCT01197482|"~     Investigational device: AKITA 2 device versus conventional metered-dose inhaler (MDI)~      Objectives: To explore if inhalative fluticasone application by means of the AKITA technology~     would result in a better symptom control in patients with severe persistent asthma as~     compared to inhalative application of fluticasone by a conventional MDI.~      Study design: open label, cross-over (one AKITA, one MDI arm)~      Patients: 20 Patients with severe persistent asthma~   "
180870|NCT01197469|"~     The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise~     capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary~     hypertension.~   "
180871|NCT01197456|"~     More than two million American women are breast cancer survivors. Approximately one-third of~     these women are premenopausal at diagnosis and face issues related to reproduction as they~     undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on~     breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire~     for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian~     function in breast cancer survivors could significantly impact physicians and patients in~     counseling, medical and surgical treatment choices, and consideration of fertility~     preservation options.~      The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian~     imaging markers that can predict ovarian failure and characterize the course of ovarian~     function after chemotherapy. The investigators plan to follow a group of young women from~     breast cancer diagnosis to five years after chemotherapy. The investigators will study the~     following risk factors: blood hormone levels that reflect ovarian function, genetic mutations~     that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI~     and ultrasound. The investigators hypothesize that these biomarkers are related to risk of~     ovarian insufficiency singly. After examining these individual risk factors for ovarian~     failure, the investigators will put them together into an Ovarian Failure Clinical Predictive~     Index. This index will be a tool similar to the Gail Model that can be used to determine~     individual risk for ovarian failure. This tool would assist young breast cancer patients and~     their physicians in making treatment decisions that would impact cancer survival and~     reproduction.~   "
180872|NCT01197443|"~     The overall intent of this study is to explore a promising mode for delivering treatment for~     childhood obesity via parent education only, and to evaluate the cost effectiveness compared~     to the current gold standard treatment of parent-and-child dual education.~   "
180873|NCT01197430|"~     Purpose: Optimal eye-hand coordination is important for volleyball players. Neck disorder may~     affect neck function and subsequently eye-hand coordination. The purpose of this study is to~     explore the vertical stability training effects on coordination of the upper extremities of~     female volleyball players.~      Methods: This study surveyed 25 players of a volleyball team, randomly assigned into the~     group A (training 1st) and group B (training 2nd). The group A includes 13 volleyball players~     and the group B includes 12. Eye-hand coordination was tested by a self-developed~     hand-stroking table device and stay time and motion time of upper extremities were~     determined. There are two testing modes, regular and random. Motion time for the electric~     probe moving between target sensor and stay time for the electric probe staying on a target~     sensors were collected for each mode, before each session of training and after the end of~     the 2nd session. In the 1st session of training, group A started vertical stability training~     and group B did control training for six weeks. In the 2nd session of training, the training~     programs were shifted between group A and B for another six weeks.~   "
180874|NCT01197417|"~     The purpose of this study is to determine the safety and efficacy of intravenous magnesium in~     shortening the duration of a pain crisis and to determine the health-related quality of life~     and short term outcomes of children treated with intravenous magnesium during an acute pain~     crisis.~   "
180875|NCT01197404|"~     Adolescents are at risk for HIV because of sexual and drug use behavior initiated during~     early adolescence, and those with mental health problems appear to be particularly~     susceptible. Problems with managing emotions may make it difficult for early adolescents to~     make good decisions about sexual and substance use behaviors. This project will develop and~     evaluate interventions for early adolescents with mental health issues. An intervention~     focused on teaching affect management skills will be compared to an intervention addressing a~     variety of health topics to determine which intervention best reduces risk behavior among~     this at-risk population.~   "
180876|NCT01197391|"~     This study will test the safety and tolerability (how the body reacts to the drug) of REGN728~     compared with placebo (an inactive substance that contains no medicine) in healthy subjects.~     The study drug and placebo will be administered by subcutaneous injection (under the skin) at~     the clinic visit. There will be 14 clinic visits, which will include 4 overnight stays.~     Subjects will be monitored by the study staff for side effects and the body's response to the~     study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be~     checked, blood and urine samples will be collected at some or all visits.~   "
180877|NCT01197378|"~     Cystinosis is an inherited disease that if untreated, results in kidney failure as early as~     the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate)~     which must be taken every six hours for the rest of the patient's life to prevent~     complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being~     studied to see if it may be able to be given less frequently, once every 12 hours, and have~     similar results to four times a day Cystagon®.~   "
180878|NCT01197365|"~     The purpose of this study is to determine the safety and efficacy of an infant formula~     supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in~     improving the gastrointestinal health and immune response in healthy term infants.~   "
180879|NCT01197352|"~     Young adults are in a critical period where they can be influenced to avoid a trajectory of~     high-risk drinking and harmful outcomes in the later adult years. The Emergency Department~     might offer a unique opportunity to reach young adults, if an easy to implement screening,~     brief intervention and referral to treatment was available. The investigators are~     investigating the feasibility and accuracy of ED-initiated and outpatient-continued~     assessment of drinking behavior in young adults using a computer-driven text messaging~     platform. Based on the subject's response to weekly assessments, the computer platform will~     send personalized motivational messages in real-time.~   "
180880|NCT01197339|"~     The purpose of this study is to generate a technology that will allow clinicians to prescribe~     behavioral treatment that should optimize tissue healing for both acute and chronic~     phonotrauma. In this study, we propose to (1): establish a non-invasive methodology for~     estimating overall mechanical dose during phonation, and component metrics of phonatory~     mechanical dose (e.g., distance dose, energy dissipation dose and time dose) from high speed~     imaging data and aeromechanical modeling, for a range of vocal fold configurations~     (Experiment 1); (2): identify mathematical relations between treatment dose parameters,~     inflammatory state of the tissue and time-varying biological consequences in the tissue, up~     to 2 wk following acute phonotrauma (Experiment 2); (3): develop a hybrid physical-biological~     model of vocal fold inflammation and treatment to identify treatment modalities that should~     optimize post-traumatic wound healing at 2 wk, for a range of acute phonotraumatic conditions~     (Experiment 3—no human subject involved), and (4): provide a preliminary test of the hybrid~     treatment models' ability to predict idealized treatment outcome in human subjects, and~     calibrate the model as needed iteratively to achieve a match between predicted and obtained~     outcomes (Experiment 4).~   "
180881|NCT01197326|"~     The purpose of this study is to assess if, compared with standard paper-based systems, an~     automated Early Warning System (EWS) resident in a spot check patient monitor, can help to~     identify deteriorating patients.~   "
180882|NCT01197313|"~     Anxiety and depression are often present in patients with chronic heart failure (CHF). This~     study aimed to evaluate the influence of anxiety and depression on the physical function,~     disability, and quality of life (QOL) in CHF. This study examined the effects of 8-week~     home-based exercise on these parameters, and investigated the correlations between these~     outcome changes.~   "
180883|NCT01197300|"~     This 1-year open-label extension to CZOL446H2337 is designed to evaluate the safety and~     efficacy of zoledronic acid twice yearly in osteoporotic children treated with~     glucocorticoids.~   "
180884|NCT01197287|"~     There are three elements to this study:~        -  Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned~          in healthy volunteers.~        -  Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of~          QAK423 are planned in COPD patients.~        -  Part C: Titrated repeat dosing for a maximum of 14 days in mild/moderate COPD patients.~      Repeat dosing is planned in COPD patients.~   "
180885|NCT01197274|"~     The purpose of this study is to compare the results skin prick tests using simple blood~     lancet (Vitrex®) with DuoTips among mite-sensitized subjects.~   "
180886|NCT01197261|"~     The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects~     suffering from severe pain due to Bladder Pain Syndrome.~   "
180887|NCT01197248|"~     Up to 50% of patients undergoing pelvic floor repair experience short-term postoperative~     voiding dysfunction, increasing the length of hospitalization, cost and anxiety among~     patients.~      The mechanism behind this problem is the sutures placed in the pubocervical fascia during the~     cystocele repair. The cited benefit of bladder plication is greater cure of cystocele. The~     existence of pubocervical fascia and the need for placement of plicating sutures over the~     bladder have been questioned.~      The objective of this study is to determine if avoiding cystocele plication in women~     undergoing surgery for cystocele decreases the need of catheterization beyond post operative~     day #2.~      We will conduct a RCT of patients undergoing transvaginal repair of midline cystocele at the~     Mount Sinai Hospital. Patients will be randomized to receiving plicating sutures versus no~     plication. This procedure may be conducted with or without concomitant correction of other~     sites of prolapse. However, they will not have any procedures for correction of stress~     incontinence.~      This study will be powered to detect a reduction in voiding dysfunction from 50% to 25% of~     patients. Using a χ2 distribution, and an alpha error of 0.05, the required sample size is 58~     patients per group.~   "
180888|NCT01197235|"~     The purpose of this study is to determine whether the drug that produce red blood cells is~     effective in the prevention of kidney dysfunction after coronary angiography in patients with~     chronic kidney disease.~   "
180889|NCT01197222|"~     Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to~     the internal abdominal wall at the beginning of a surgical case and remains in position until~     completion of the surgery, enabling the surgeon to clean the camera lens without removing it~     from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety~     of using the EndoClear device as a laparoscopic lens cleaning device.~   "
180903|NCT01197040|"~     A multicenter, randomized, study will be performed to evaluate the efficacy of low dose~     steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in inducing~     remission in adults with minimal change nephrotic syndrome (MCNS). One hundred and fourteen~     patients (CPP decision 2009-04-02-a5) will be included in this study. They will be randomly~     assigned to an open label treatment with either prednisone~      1 mg/kg/day (arm A) or 0,5 mg/kg/day plus myforticR 1440 mg/day (arm B) for four weeks. The~     outcome will be compared during one-year follow up~   "
180890|NCT01197209|"~     This is a phase I neoadjuvant gene therapy followed by prostatectomy, open-label,~     dose-escalation trial for prostate cancer patients with high risk of local recurrence after~     radical prostatectomy. Patients entered into this trial will have Prostate Cancer of Clinical~     stage T1c, T2 or T3 with a Gleason Score of between 7 (4+3) and 10 at the time of enrollment.~     Patients will receive three 1 mL injections (3 mL total volume) of Ad-REIC/Dkk-3 into the~     prostate prior to undergoing a radical prostatectomy. Three patients will be treated at each~     dose level unless a dose-limiting toxicity (DLT) is observed or MFD (defined as 1 x 10e12~     vp/treatment) is achieved with expansion for up to 6 more patients at the MTD or MFD.~   "
180891|NCT01197196|"~     This study involves a randomized controlled trial to test the efficacy of behavioral weight~     loss as a treatment for migraine in obese females aged 18 to 50 years. The primary aim is to~     examine whether participants assigned to a behavioral weight loss treatment condition report~     greater pre- to post-treatment reductions in migraine headache frequency than participants~     assigned to a migraine education condition.~   "
180892|NCT01197183|"~     This observational survey with prospective and/or retrospective follow-up is designed to~     study practices for the initial treatment of hypothyroidism in France without modifying~     subject treatment.~   "
180893|NCT01197170|"~     The goal of this clinical research study to find the highest tolerated dose of anastrozole~     alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib~     (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients~     with advanced cancer. The safety of these drug combinations will also be studied.~   "
180894|NCT01197157|"~     The main objective of antiviral therapy of patients with chronic hepatitis C (CHC) is the~     sustained elimination of the hepatitis C virus (HCV). The standard of care (SOC) is~     peginterferon alfa-2a/-2b with ribavirin for 48 weeks or 24 weeks according to HCV genotype.~      However, this approach is not sufficient to substantially improve the sustained virologic~     response (SVR) rates. Therefore, new therapies are needed to treat patients with hepatitis C~     virus (HCV) infection. Nitazoxanide (NTZ), originally used to treat cryptosporidium parvum~     infection, recently was shown to have an unexpected antiviral activity in the HCV replicon~     system and in chronically infected patients.~      The aim of this work is to study impact of nitazoxanide therapy in addition to~     peginterferon/ribavirin combination on virologic responses in patients with chronic hepatitis~     C genotype 4.~      Patients will be enrolled in this study and will be randomly assigned in a 1:1 ratio into 2~     groups:~      Group A: comprises 100 CHC patients who will receive the standard of care treatment,~     peginterferon-alf 2a plus weight-based ribavirin for 48 weeks.~      Group B: comprises 100 CHC patients who will receive nitazoxanide monotherapy at a dose of~     500 mg twice daily for 12 weeks as a lead-in phase followed by triple therapy, nitazoxanide~     500 mg twice daily plus peginterferon alfa-2a, and weight-based ribavirin for 48 weeks.~      Data will be collected and statistical analysis will be done comparing the groups regarding~     response to antiviral therapy. Final results will be discussed and compared to similar~     studies published in peer reviewed journals and international conferences.~   "
180895|NCT01197144|"~     The purpose of this study is to obtain increased knowledge concerning central pain and~     fatigue processing in rheumatoid arthritis, and how these conditions are influenced by~     treatment with Tumor Necrosis Factor (TNF) blockade with adalimumab.~   "
180896|NCT01197131|"~     Deviation of hormone formation within nerve cells and nerve system provides autism spectrum~     disorder and neurodevelopment retardation through interaction of steroids with~     neurotransmitter-receptors, calcium-channel receptors and genomic interaction via nuclear~     steroid receptors.~      Urinary steroid metabolites will be compared between children with autism spectrum disorder~     and healthy controls.~   "
180897|NCT01197118|"~     Gastric cancer is one of the most prevalent malignancies in China; the survival rate remains~     poor despite potentially curative resections. Complete surgical resection is the only~     potentially curative therapy available to patients with gastric cancer. However, even after a~     complete resection with negative margins, many patients will experience recurrence. In recent~     years, the radiation therapy in the carcinoma of the stomach represents a new issue that~     should be addressed accompanying the development of radial physics and radial biology, the~     clinical application of computed tomographic (CT) simulation and digital reconstitution~     technique, especially the application of 3-dimensional conformal and intensity modulated~     radiation therapy. Radiation therapy plus concurrent chemotherapy has been demonstrated to~     cause a significant improvement in overall and disease-free survival according to Intergroup~     Trial 0116/SWOG 9008. So the investigators designed the trial to see whether a postoperative~     sequence chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve~     survival for advanced gastric cancer.~   "
180898|NCT01197105|"~     The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a~     natural product (Schinus terebinthifolius) used by children with gingivitis.~   "
180899|NCT01197092|"~     A treatment with the concept of mitochondrial medication developed by Dr Heinrich Kremer can~     demonstrably improve and successfully treat actual parameters of Diabetes Mellitus II as well~     as its risk factors.~   "
180900|NCT01197079|"~     The objectives of this study are:~        1. to determine the degree of understanding and perceived risks for human papillomavirus~          (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and~          identify potential barriers to HPV vaccine access and utilization in a population of~          young men who have sex with men (MSM) (under 26 years of age)and in parents of boys aged~          9 to 18 years~        2. to determine HPV vaccine acceptance and predictors of acceptance in a population of~          young MSM and in patients of boys ages 9 to 18 years~        3. to develop strategies to overcome potential barriers to vaccination and improve vaccine~          access and utilization via development of targeted educational initiatives.~   "
180901|NCT01197066|"~     This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy~     of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with~     active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.~   "
180902|NCT01197053|"~     This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and~     efficacious for desensitizing children with peanut allergy.~   "
186702|NCT01120795|"~     The purpose of this study is to see if treatment of chronic hepatitis C in people who are on~     opiate replacement therapy such as methadone or buprenorphine (including patient who still~     inject drugs) is safe and effective.~   "
180907|NCT01196988|"~     This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK)~     Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to~     describe safety and immunogenicity of the GSK Biologicals' investigational vaccine~     GSK2321138A in children aged 6 to 35 months.~   "
180908|NCT01196975|"~     This study is designed to test the immunogenicity and safety of an investigational influenza~     vaccine, in adults compared to two other influenza vaccines.~      This study will also evaluate the lot-to-lot consistency of three vaccine lots.~   "
180909|NCT01196962|"~     There is no randomized controlled trial to compare the rates of complications associated with~     internal jugular and subclavian venous catheterization. The aim of this study is to compare~     mechanical, infectious, and thrombotic complications of internal jugular and subclavian~     venous catheterization. An improved understanding of CVC-related risks might help clinicians~     to choose one approach over the other in specific clinical settings.~   "
180910|NCT01196949|"~     It is hypothesized that a combination approach would produce increased clinically and~     statistically significant outcomes as opposed to standard single intervention, inclusive of~     comparatively greater reduction in pain, improvement in range of motion, proprioception and~     function with an associated quicker recovery time.~      Chronic ankle instability (CAI) is a frequently encountered condition of the musculoskeletal~     system. Various individual treatment options have previously been compared to one another in~     clinical trials, however there is paucity of literature with regards to combined treatment~     choices versus individual therapy. The purpose of this study is to investigate the relative~     effectiveness of combined manipulation and rehabilitation versus rehabilitation only, in the~     management of CAI.~      The study will be conducted as a single blinded randomised and comparative clinical trial at~     Cleveland Chiropractic College and Durban University of Technology.~   "
180911|NCT01196936|"~     Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate~     may fight breast cancer by blocking the use of estrogen by the tumor cells~      This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast~     cancer risk in radiation-induced cancer survivors.~   "
180912|NCT01196923|"~     The purpose of this study is to confirm the safety and effectiveness of the CardioFocus~     Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.~   "
180913|NCT01196910|"~     The aim of the study is to assess the effect of left or right high-frequency DTMS on ADHD~     symptoms, cognitive performance and decision-making ability of ADHD adults, and to compare~     this to the effect of sham DTMS on ADHD adults~   "
180914|NCT01196897|"~     This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure~     Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2~     stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study~     to evaluate the initial use of the next generation WATCHMAN Device.~   "
180915|NCT01196884|"~     Primary ITP has wide heterogenous biology, presentation and response to therapy.~      The immune-genetic assessment of ITP may help to identify differences among patients with ITP~     and optimize the therapeutic choice.~   "
180916|NCT01196871|"~     The purpose of this study is to determine the effects of AT1001 on the safety of agalsidase,~     and the effects of agalsidase on the safety of AT1001.~   "
180917|NCT01196858|"~     During the 1990s, evidence began to emerge of the long duration of untreated illness prior to~     receiving treatment for patients with psychotic disorders. Studies across the world on first~     episode psychosis have consistently found an average of 1 - 2 years between the onset of~     psychotic symptoms and the start of treatment. Lengthy treatment delay has immediate~     implications such as unnecessary distress for patients and families, and may also compromise~     potential recovery when treatment is initiated.By understanding how and why substantial~     delays occur the investigators may be able to better design interventions to facilitate~     better earlier treatment. The components of DUP can be conceptualised as comprising 3~     distinct intervals: help-seeking delay, referral delay and delay in mental health services.~     In this study the primary aim is to establish the level of DUP in nordland, and explore the~     components of this variable. Help-seeking delay will be investigated by interviewing patients~     presenting at the central mental health hospital in Nordland about their psychosis onset and~     pathways to care. Referral delay will be investigated by a questionnaire about the referral~     pratices among GPs in Nordland. Delays in mental health services will be investigated by~     focus group interviews with leaders and professionals at the 7 community mental health~     centers in Nordland. This knowledge is believed to be crucial for developing services that~     can reduce DUP and give this patient population earlier access to adequate treatment.~   "
180918|NCT01196845|"~     The main objective of this study is to evaluate the decrease of inflammation of adipose~     tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by~     continuous positive airway pressure (cPAP).~      An interim analysis will be performed when 40 patients will be included.~   "
180919|NCT01196832|"~     Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by~     both bronchial inflammation and remodelling.~      Bronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition, the~     number of eosinophils can be also increased during exacerbation.~      Airway remodelling is an abnormal tissue repair following bronchial inflammation, which~     contributes to none reversible pathological features, such as bronchial and peri-bronchial~     fibrosis. It also influences the prognosis of COPD and its mechanisms remain largely unknown.~     The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis~     or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement~     in COPD airway remodelling remain unknown.~   "
180920|NCT01196819|"~     The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort~     of its safety, efficacy and delivery system in treating CAD.~   "
180921|NCT01196806|"~     The purpose of this study is to compare Measurements of Arterial Blood Pressure by L&T NIBP~     Module With Invasive Arterial Blood Pressure in Neonates.~   "
181007|NCT01195662|"~     The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can~     improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled~     hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin~     Receptor Blocker (ARB).The safety of this treatment will also be studied~   "
180922|NCT01196793|"~     A significant number of children 0 to 5 years of age are seen in paediatric Accident &~     Emergency departments (A&E) with feverish illness. Most of these patients could safely be~     managed in a primary care setting, particularly with guidelines in place on how to optimally~     assess these children. Some patients, however, will require admission, either because of a~     potentially serious underlying disease or because of other factors, for example parental~     concern or difficulties in communication because of language barriers. An increase in the~     number of children attending A&E departments with feverish illness as well as a rise in the~     volume of admissions has been noted over time. To enable an appropriate adaptation of acute~     medical services for children an in depth understanding of the assessment and admission~     processes is crucial.~      This study primarily aims to describe factors associated with hospitalisation of children~     aged 3 months to 5 years presenting with fever to an urban paediatric A&E departments by~     describing and analysing characteristics both of those patients admitted to hospital and~     those managed in the community. To complement this, information on the short-term healthcare~     utilization by families attending the emergency department because of feverish illness will~     be collected. The study will be carried out in one participating centre in Switzerland and~     the United Kingdom, respectively, to enable a head to head comparison of the assessment and~     admission practices in two European countries. The resulting data will be used as the basis~     for further research in this area and will provide information on how to optimally structure~     service provision in acute febrile childhood illness.~   "
180923|NCT01196780|"~     This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab)~     in patients with active rheumatoid arthritis who have had an inadequate response or are~     intolerant to anti-TNF therapy. Data will be collected from patients initiated on~     MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each~     patient data will be collected for 92 weeks.~   "
180924|NCT01196767|"~     This is a prospective double-blinded and randomised study involving patients undergoing~     cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr~     continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters~     inserted at the lateral edges of the sternum will be studied, versus a control group in which~     normal saline will be infused in the same conditions.~   "
180925|NCT01196754|"~     This is a prospective clinical monocentric study in ICU with sedated ventilated patients with~     sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of~     sevoflurane.~   "
180926|NCT01196741|"~     The purpose of this study is to investigate whether the addition of the Src inhibitor~     saracatinib (AZD0530) to weekly paclitaxel improves efficacy, compared with paclitaxel plus~     placebo, in patients with relapsed platinum-resistant ovarian cancer. The trial will also~     determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib~     should proceed to a phase III trial.~   "
180927|NCT01196728|"~     The primary objective of this study is to assess the safety and tolerability of the~     Glucagon-like peptide-1 (GLP-1) peptide analogue CM3.1-AC100 after single subcutaneous (sc)~     doses in patients with T2DM.~   "
180928|NCT01196715|"~     REGIME is comparing two treatments, with Darbepoetin Alpha (DA) and Filgrastim (Granulocyte~     Colony Stimulating Factor, G-CSF), to the standard treatment for Myelodysplastic Syndrome~     (MDS).~      After giving Informed Consent patients will undergo a number of tests to confirm eligibility.~     Once eligibility is confirmed patients will be randomly assigned to one of the three~     treatments group: A: Darbepoetin Alpha (DA), B: Darbepoetin Alpha and Filgrastim (DA+G-CSF),~     C: Blood transfusion only. Patients will be required to attend the clinic once a month for 24~     weeks. After 24 weeks if a patient has reacted favorably to the treatment they may continue~     on the treatment regime up to 52 weeks. After week 24 all patients will be required to attend~     the clinic twice more, at week 36 and 52.~      Patients will be followed for a further 5 years to record loss of response, transformation to~     Acute Myeloid Leukaemia and/or Refractory Anemia with Excess Blasts and death.~   "
180929|NCT01196702|"~     The purpose of this study is to discover if differences in the surface markers of B-cells~     (antibody producing cells of the immune system) in Common Variable Immune Deficiency (CVID)~     are related to CVID or its complications/treatment (e.g. bronchiectasis, granulomatous~     disease, immunoglobulin treatment).~      The study hypothesis is that the altered B-cell surface markers are related to CVID, and not~     to the complications or treatment of CVID.~   "
180930|NCT01196689|"~     The purpose of this study is to study pharmacokinetics in adolescents.~   "
180931|NCT01196676|"~     This is a single ascending dose study to assess the safety, tolerability and pharmacokinetics~     of AZD4451.~   "
180932|NCT01196663|"~     This Clinical study is preformed in order to estimate the performance of the TMS thermometer~     and to make a final tuning of the thermometer mathematical algorithm.~      Body temperature of men, women and children will be measured using the TMS thermometer.~      Each Patient will be measured both with the TMS thermometer and with an esophageal or urinal~     thermometer as a reference.~   "
180933|NCT01196650|"~     This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients~     with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will~     compare 2 formulations of the IN 10 003 to placebo~   "
180934|NCT01196637|"~     Thoracic outlet syndrome is caused by compression of the brachial plexus, in most cases under~     the pectoralis minor muscle in the infraclavicular region of the shoulder. The hypothesis is~     that ultrasound imaging can be used to visualize brachial plexus compression and distortion~     of the pectoralis muscle during arm activity, such as abduction, and that normal subjects~     will not demonstrate any plexus compression or muscle distortion.~   "
180946|NCT01196481|"~     Patients of cirrhosis will be enrolled who have large esophageal varices, which have never~     bled. After successful screening baseline hepatic venous pressure gradient (HVPG) will be~     measured. Tablet carvedilol 3.125 mg BD for 1 week will be started. It will be increased to~     6.25 mg BD and continued for next 7 weeks. After completion of 8 weeks the hepatic venous~     pressure gradient (HVPG) will again be measured to find out responders (hepatic venous~     pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure~     gradient <12 mm Hg) and non responders (hepatic venous pressure gradient <20% reduction).The~     responders will be excluded from the study while the non responders will be randomize into~     carvedilol+VSL#3 versus Endoscopic Variceal Ligation.~   "
180935|NCT01196624|"~     Subjects~      Forty consecutive patients fulfilling the DSM-IV diagnostic criteria for PTSD will be~     recruited from the inpatient and outpatient treatment programs at the Beer Sheva Mental~     Health Center. Patients will complet a course of 10 daily rTMS sessions.~      After receiving a full explanation of the procedures, all subjects will sign a written~     informed consent statement approved by the Helsinki Ethics Committee of Ben-Gurion~     University.~      Study Design~      The study suggested here will recruit 40 patients with DSM-IV PTSD also demonstrating at~     least moderately severe flashbacks. Each of the subjects will be recruited randomly to one of~     4 groups:~        1. Right DLPF Rtms (10Hz) co-administered with neutral visual and/or auditori stimuli;~        2. Right DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli~          mimicking experiences appearing during the patients flashbacks;~        3. Left DLPF Rtms (10Hz) co-administered with neutral visual and or auditori stimuli;~        4. Left DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli~          mimicking experiences appearing during the patients flashbacks;~      Treatment Characteristics~      rTMS will be performed with a Magstim stimulator (Magstim Company, Whitland, U.K.) The motor~     threshold was determined in each subject once, before treatment. This was defined as the~     lowest stimulation intensity capable of inducing a visible movement at least five times out~     of 10 stimulations.~      The position of the right dorsolateral prefrontal cortex will be defined as 5 cm anterior (in~     a parasagittal line) to the motor cortex. The stimulus intensity will be 80% of the patient's~     motor threshold intensity.~      Treatments will be given for 20 minutes per day over 10 working days. Both subjects received~     high-frequency rTMS) received 10 Hz for 2 seconds per train; the intertrain interval was 58~     seconds. For each participant the stimulus was administered over the right dorsolateral~     prefrontal cortex.~      Rating Scales~      The ratings of PTSD symptoms, anxiety, and depression willm be carried out by an expert~     investigator who will be blind to the stimulation condition. The patients will be assessed at~     four time points—before TMS (baseline), at day 5, at day 10, and at day 24 (14 days after the~     intervention). The instruments used will be as follows:~      The PTSD Checklist The Treatment Outcome PTSD Scale The Hamilton Anxiety Rating Scale The~     Hamilton Rating Scale for Depression PTSD symptoms were assessed by using the Hebrew version~     of the Clinician-Administered PTSD Scale.~   "
180936|NCT01196611|"~     The study compares two different approaches of voice therapy. Vocal Functional Exercises~     (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II -~     Tecnisystem do Brasil TSI 1210).~   "
180937|NCT01196598|"~     To verify if pelvic floor muscle training program and/or a hypopressive exercise program~     could improve women with stage II of pelvic organ prolapse, their symptoms or pelvic floor~     muscle strength.~   "
180938|NCT01196585|"~     This study aims to compare the diagnostic efficiency and reliability of Abrams' needle~     pleural biopsy under computerized tomography guidance with that of cutting-needle pleural~     biopsy under ultrasonography guidance in patients with pleural effusion.~   "
180939|NCT01196572|"~     The purpose of this study is to determine whether laser internal urethrotomy (IU) is as~     efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures~     regarding post operative urination outflow, stricture recurrence rate and possible post-~     operative complications~   "
180940|NCT01196559|"~     The purpose of this study is to evaluate the objective response rate and safety in~     platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients~     treated with vinorelbine and gemcitabine combination chemotherapy.~   "
180941|NCT01196546|"~     This study will assess the efficacy and safety of combination therapy of~     vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000~     mg/day.~   "
180942|NCT01196533|"~     1. Aim:~           The aim of the clinical trial is to study the accuracy of the TensorTip device compared~          with registered (FDA-approved) invasive and non-invasive devices.~        2. Hypothesis:~      Human physiological biomarkers may be measured from the color distribution of the internal or~     external (skin) tissue. The technology of the TensorTip finger-mounted device is based on the~     color distribution of the peripheral blood tissue, which enables the measurement of certain~     biomarkers and vital signs under consideration.~   "
180943|NCT01196520|"~     Burkitt lymphoma (BL) is an aggressive monoclonal B-cell malignancy that is rare (sporadic)~     worldwide, but is 100-fold more common (endemic) in equatorial Africa, particularly among~     children. Epstein-Barr virus (EBV) and malaria are epidemiologically linked to endemic BL in~     epidemiologic studies, but questions remain about role of EBV variants and the evidence for~     association with malaria is weak. EBV is ubiquitous, yet only few children develop BL,~     possibly because only a few EBV variants are pathogenically relevant. The association of BL~     with malaria is based on ecologic and non-comparative clinical studies. Two case-control~     studies have reported significant association of high anti-malarial antibodies with BL (OR=5_~     among children in Uganda and in Malawi, but selection bias (cases and controls came from~     dissimilar geographical areas) and reverse causality bias were limitations. Three studies~     were conducted in the 1960s and 70s to test association of carriage of malaria-resistance~     gene with BL, two of which reported a significant or marginal inverse association. These~     pioneering studies were small (240 cases all together) and looked at one polymorphism in one~     gene (sickle cell gene). Improvements in technologies to characterize genetic variation allow~     the EBV and malaria hypotheses to be examined with greater power by looking at genetic~     variation across multiple genes.~      Epidemiology of Burkitt lymphoma in East African children and minors (EMBLEM) is a~     case-control study of 1500 BL cases and 3000 age-, sex- and residence-frequency matched~     controls we are proposing to conduct in East Africa. The study will enroll cases at four~     hospitals in four regions in East Africa, where malaria transmission is holoendemic and year~     round. The controls will be enrolled from general population attendees at Health Center II~     (HC-II) units where the cases originated. The primary study objectives are: 1) to test the~     hypothesis that genetic resistance to malaria is associated with a lower risk of BL, and 2)~     to use genome-wide association methods to discover genetic variation that may be associated~     with decreased or increased risk of BL. Because genetic variation conveys no information on~     actual exposure to malaria or EBV, in secondary analyses, we will use empiric epidemiological~     questionnaire and laboratory methods: a) to measure exposure to malaria and its association~     with BL, and b) to measure EBV variants and their association with BL. To examine issues~     related to bias and to obtain data to correct for deviations, we will also enroll 2250~     population controls from 5% of the villages to obtain population distribution of key~     exposures variables. This data will be used to reweight the distribution in HC-II controls~     back to the general population.~   "
180944|NCT01196507|"~     Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal~     varices with or without red color signs and have not bled previously will be enrolled. After~     baseline evaluation, the participants will be randomized to receive either Placebo or~     Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary~     endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or~     Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change~     in CTP and MELD score& adverse events.~   "
180945|NCT01196494|"~     INTRODUCTION: There are several alternatives for one-stage emergency treatment of obstructive~     left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon lavage (IOCL) with~     primary anastomosis, and the placement of a stent as a temporary measure prior to scheduled~     surgery. At present, it is not clear whether emergency perioperative lavage or the placement~     of a stent is the better technique. The hypothesis is that IOCL and primary anastomosis is~     equal safe or even safer than placement of a stent as a temporary measure prior to scheduled~     surgery, less length of stay and less cost.~      OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the~     point of view of morbimortality, economic cost, and long-term survival.~      MATERIAL AND METHODS:~      Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were~     divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A~     simple randomization system was used. The estimated sample size required per group was 21~     patients. Demographic variables, risk prediction models, postoperative morbimortality,~     staging, complications due to the placement of stent, surgical time, clinical follow-up,~     health costs and follow-up of survival were recorded.~   "
180947|NCT01196468|"~     In Europe many patients infected with HIV remain undiagnosed, although this percentage varies~     between 15-80% across the continent. In the UK it is estimated to be 27%. Undiagnosed HIV~     results in increased morbidity and mortality and reduced treatment response, as appropriate~     health interventions are delayed. It also has adverse public health implications, with those~     individuals unaware of their HIV status being more likely to transmit the virus.~      An important public health issue is how to diagnose more individuals with HIV earlier in the~     course of their infection. In the US, the Centre for Disease Control and Prevention (CDC) has~     introduced testing guidelines whereby all individuals are tested, unless they object, at any~     point of contact with the healthcare system - the opt-out testing guidelines.~      At the HIV in Europe Conference held in November 2007, the consensus, which included~     patient and public involvement, was that such an approach would not be suitable for Europe.~     The Conference recommended further development of focused HIV testing in patients presenting~     with certain clinical conditions and diseases - the indicator disease'' testing guidelines.~      Cost effectiveness analyses suggests cost savings if a screened population has an HIV~     prevalence of at least 1%, although this rate may be as low as 0.1%. However, there is very~     little - if any - evidence regarding HIV prevalence for certain conditions and diseases in~     specific and easy to identify sections of society. The focus of attention is on those~     conditions and diseases which occur more frequently in individuals known to be infected with~     HIV.~      The aim of this study is to assess HIV prevalence for several diseases and conditions, within~     a specific segment of the population not yet diagnosed with HIV, who present for care with~     that specific disease or condition. These conditions have been selected as they occur~     frequently in individuals already diagnosed with HIV infection. This is a pilot study to~     inform phase two, which will involve more diseases and conditions with a wider participation~     of centres across Europe.~   "
180948|NCT01196455|"~     This is an open-label, non-comparative efficacy and safety study of Capecitabine and~     Mitomycin C as first-line treatment in patients with previously untreated metastatic breast~     cancer.~   "
180949|NCT01196442|"~     RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and numbness~     caused by chemotherapy. PURPOSE: This pilot trial studies electrical stimulation pain therapy~     in treating chronic pain and numbness caused by chemotherapy in patients with cancer.~   "
180950|NCT01196429|"~     This phase II trial studies how well temsirolimus, carboplatin, and paclitaxel as first-line~     therapy works in treating patients with newly diagnosed stage III-IV clear cell ovarian~     cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving temsirolimus with combination chemotherapy may be an~     effective treatment for ovarian cancer.~   "
180951|NCT01196416|"~     This phase Ib/II trial studies the side effects and best dose of gamma-secretase/Notch~     signalling pathway inhibitor RO4929097 when given together with cisplatin, vinblastine, and~     temozolomide and to see how well they work in treating patients with recurrent or metastatic~     melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cisplatin, vinblastine, and temozolomide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving gamma-secretase/Notch signalling pathway inhibitor RO4929097 together with~     combination chemotherapy may kill more tumor cells.~   "
180952|NCT01196403|"~     RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than~     is used in standard surgery. It is not yet known whether minimal-access surgery to remove the~     bladder is more effective than standard surgery to remove the bladder in treating patients~     with bladder cancer.~      PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works~     compared with minimal-access surgery in treating patients with bladder cancer.~   "
180953|NCT01196390|"~     This randomized phase III trial studies how well radiation therapy, paclitaxel, and~     carboplatin with or without trastuzumab work in treating patients with esophageal cancer.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,~     such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of~     tumor cells to grow and spread. It is not yet known whether giving radiation therapy and~     combination chemotherapy together with or without trastuzumab is more effective in treating~     esophageal cancer.~   "
180954|NCT01196377|"~     Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for~     personalized medicine by identification of treatment-response phenotypes that are important~     determinants of outcome. The Specific Aim of this study is to determine the feasibility of~     this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different~     albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr.~     Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.~   "
180955|NCT01196364|"~     The investigators hypothesize exercise increases short term appetite and food intake, and~     interferes with satiety and satiations to a preload in normal weight, boys.~   "
180956|NCT01196351|"~     The investigators hypothesize exercise increases short term appetite and food intake, and~     interferes with satiety and satiations to a preload in normal weight, overweight and obese~     boys.~   "
180957|NCT01196338|"~     The primary objective of the investigators randomized controlled trial is to determine if~     early protected weightbearing and ankle range of motion after surgical treatment (open~     reduction internal fixation - ORIF) for ankle fractures improves the rate of return to work~     and functional outcome compared to postoperative ankle immobilization in a non-weightbearing~     cast.~   "
180969|NCT01196182|"~     Congenital heart defects (CHD) are the most common major human birth malformation, affecting~     ~8 per 1,000 live births. CHD are associated with significant morbidity and mortality, and~     are second only to infectious diseases in contributing to the infant mortality rate. Current~     understanding of the etiology of pediatric cardiovascular disorders is limited.~      The Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) is a multi-center, prospective~     observational cohort study. Participants will be recruited from the Pediatric Cardiac~     Genomics Consortium's (PCGC) centers of the NHLBI-sponsored Bench to Bassinet (B2B) Program.~     Biological specimens will be obtained for genetic analyses, and phenotype data will be~     collected by interview and from medical records. State-of-the-art genomic technologies will~     be used to identify common genetic causes of CHD and genetic modifiers of clinical outcome.~      To accomplish this, the PCGC will develop and maintain a biorepository of specimens (DNA) and~     genetic data, along with detailed, phenotypic and clinical outcomes data in order to~     investigate relationships between genetic factors and phenotypic and clinical outcomes in~     congenital heart disease.~   "
180958|NCT01196325|"~     The study will investigate changes in the structure and function of blood vessels in the~     front and back of the eye following laser and anti-VEGF treatments for sight-threatening~     diabetic eye disease. Sixty four volunteers will be recruited, including age-matched control~     subjects and diabetic patients who require conventional or contemporary treatment for~     pre-existing diabetic eye disease. Volunteers will be assessed before and after treatment~     using state-of-the-art techniques to measure vision, the rate of blood flow and structure at~     the front and back of the eye and the effectiveness of blood flow delivery. Changes following~     treatment in these novel, non-invasive techniques will be quantified and described. We~     anticipate that conventional and new / developing treatments will lead to narrowing of the~     vessels and consequent reduction of blood flow at the back and front of the eye. There will~     be a strong relationship between structural changes of the eye and functional changes of~     blood vessels at the front and back of the eye. The results of this study will improve our~     understanding of the impact of the various treatments on the entire eye. The research will~     also ensure an improved understanding of the mechanisms of action of the various treatments~     and will provide insight of reasons for good or poor outcomes, based upon specific changes in~     structure and blood flow.~   "
180959|NCT01196312|"~     Anxiety Sensitivity Treatment for Heroin Users is a development project targeting mild and~     above levels of anxiety sensitivity that will involve the testing of a specialized protocol~     for improving treatment retention and outcomes for heroin dependent individuals in a~     residential substance use treatment. ASTH-HR will integrate established treatment modules~     such as Healthy Relationships, along with interoceptive exposure, affect management, and~     psycho-education exercises developed for anxiety prevention and treatment programs with~     standard substance use treatment.~   "
180960|NCT01196299|"~     This project aims to study the prognostic ability of various MRI imaging markers in the~     evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at~     each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison~     to the TBI patients.~      It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional~     connectivity, and tissue microstructure will be related to the clinical status of the~     patient, as well as their social and occupational outcomes.~   "
180961|NCT01196286|"~     The goal of this study is to determine whether pairing multifamily group psychoeducation with~     cognitive remediation may facilitate improved outcomes among individuals with recent-onset~     psychosis.~   "
180962|NCT01196273|"~     HIV-infection is associated not only with a reduced function of the immune system, but also~     linked with diseases of other organ systems, in particular with the heart.~      Heart conditions that have been described with HIV include~        -  Pericarditis,~        -  Pleural effusion~        -  Pulmonary hypertension (Venedic classification typ II)~        -  Dilated cardiomyopathy~        -  Heart failure~        -  Myocarditis~        -  Bacterial endocarditis~        -  Heart valve disorders In addition to previously stated disorders of the heart, the~          premature atherosclerosis of coronary arteries, a further even more important disease of~          the heart in this patient population, went into the focus of most HIV-researchers and~          physicians.~      Premature atherosclerosis of coronary arteries results in coronary calcification, angina~     pectoris, myocardial infarction and sudden death. HIV-positive patients are at greater risk~     for a variety of heart-related conditions, including coronary artery disease. It is assumed,~     that HIV infection doubles the risk of a heart attack, according to recent research.~      The reason for this link between HIV and heart-related conditions is unknown, but secondary~     infections that affect the heart muscle and coronary arteries have a greater chance of~     occurring in people with compromised immune systems. In addition, the HI-virus itself had~     been detected in the myocardium and might have an impact on the premature of cardiovascular~     diseases.~      Furthermore, some of the medications used to treat HIV patients (antiretroviral therapy, ART)~     are assumed to have heart-related side effects.~      Therefore, current treatment regimens for HIV infection have to be balanced against the~     marked benefits of antiretroviral treatment. Nevertheless, prevention of coronary heart~     disease should be integrated into current treatment procedures of HIV-infected patients.~      The link between the heart and HIV is well established but not well understood. Therefore,~     further results are needed for efficient guidelines for the prevention, diagnostic and~     therapy of HIV-associated cardiovascular diseases.~   "
180963|NCT01196260|"~     This study will examine a new combination of drugs: Capecitabine and Oxaliplatin for the~     treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by~     the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs~     is experimental (not approved by the FDA as standard treatment), but is a widely used~     treatment option and preliminary studies have shown that treatment with the combination has a~     positive effect on metastatic colorectal cancer.~   "
180964|NCT01196247|"~     The purpose of the study is selecting second line therapy for patients with pancreatic cancer~     using molecular profiling will improve 1 year survival.~   "
180965|NCT01196234|"~     This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for~     2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor~     receptor (EGFR) mutations.~      Expanded acronym : [P]aclitaxel/Ca[r]boplatin (PC) followed by Gef[i]tinib in A[d]vanc[e]d~     Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.~   "
180966|NCT01196221|"~     The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify~     the plaque composition and lipid content of plaques and will have the potential for repeated~     in vivo measurements. Simultaneously this study aims to develop US plaque imaging as a~     screening tool to select plaque phenotypes of interest for clinical trials (a large LRNC).~     For plaque composition imaging by MRI the researchers aim to increase scan resolution and~     decrease scan time. For quantifying plaque lipid content the researchers aim to develop an~     MRS protocol. Subsequently, the researchers intend to study the reproducibility of plaque~     composition and lipid content measurements by MRI, MRS and Ultrasound in subjects that have~     carotid artery plaques.~   "
180967|NCT01196208|"~     The purpose of this study is to provide the option of brentuximab vedotin treatment to~     eligible patients in studies SGN35-005 and C25001~   "
180968|NCT01196195|"~     The trial will evaluate the pharmacokinetics, safety, efficacy and acceptability of twice-~     and once-daily dosing of lopinavir/ritonavir tablets (Kaletra) dosed by weight in HIV-1~     infected children who are currently taking lopinavir/ritonavir as part of their combination~     antiretroviral therapy and who are currently achieving virological suppression (<50~     copies/ml). Specifically:~        -  To confirm weight-based dosing recommendations by evaluating the pharmacokinetics of~          twice-daily lopinavir/ritonavir half strength formulation tablets dosed on body weight~          and comparing to historical adult and paediatric data of pharmacokinetics of~          lopinavir/ritonavir soft gel capsules and oral solution respectively (1, 2).~        -  To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with~          once-daily dosing in the same children.~        -  To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to~          twice-daily dosing in terms of virological suppression at 48 weeks. Adherence and~          acceptability will also be compared.~   "
180970|NCT01196169|"~     This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared~     to another one which is vancomycin when given around the time of joint replacement surgery.~     Vancomycin is recommended for perioperative prophylaxis in methicillin resistant~     Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty.~     Daptomycin has not been recommended for this indication but it is FDA approved for treatment~     of MRSA blood stream and skin and soft tissue infections. Data collected during this study~     may support the use of daptomycin for this indication and may also be used for other research~     purposes that have not yet been specified.~   "
180971|NCT01196156|"~     This non-interventional study for prospective follow up of a cohort of 220 subjects born~     small for gestational age (SGA) is planned for the purpose of finding out if normalisation of~     adult height is associated or not with metabolic alterations and if true, their magnitude and~     relevance as well as to detect warnings throughout the treatment period that may be useful~     for prevention or therapy. This study would help in answering the question if the SGA and~     growth hormone (GH) association results in insulin resistance and if affirmative, who~     develops it as well as its impact on other metabolic parameters that precedes type 2~     diabetes.~   "
180972|NCT01196143|"~     This is a phase IV non-interventional, multicentric observational study to evaluate the~     baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count~     (AFC) and age as prognostic factors of the outcome of the in-vitro~     fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving~     Gonal-f for controlled ovarian hyperstimulation (COH).~   "
180973|NCT01196130|"~     The goal of this clinical research study is to test for biomarkers in patients with~     metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical~     markers in the tumor tissue and/or blood that may be related to your reaction to cancer~     drugs.~      This is an investigational study. This study's biomarker testing is for research purposes~     only.~      Up to 1280 patients will be enrolled in this study. All will be enrolled at MD Anderson.~   "
180974|NCT01196117|"~     Patients with Obstructive Sleep Apnea Syndrome (OSAS) will evidence higher levels of salivary~     cortisol and alpha-amylase levels prior to use of placebo and continuous positive airway~     pressure (CPAP) and will evidence a decrease in these levels after consistent use of~     continuous positive airway pressure (CPAP) therapy as compared to placebo. Their level of~     sleepiness will also decrease with the use of CPAP therapy and will correlate with the levels~     of salivary cortisol and alpha-amylase in relation to their subjective sleepiness scale,~     Psychomotor Vigilance Test (PVT), and pupillometry.~   "
180975|NCT01196104|"~     This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy~     and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin~     glargine versus insulin aspart in combination with insulin glargine in subjects with type 2~     diabetes.~   "
180976|NCT01196091|"~     The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two~     different doses of LY2127399 administered in addition to standard of care therapy in patients~     with active SLE.~   "
180977|NCT01196078|"~     This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in~     chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be~     randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and~     8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study~     treatment is until disease progression.~   "
180978|NCT01196065|"~     This open-label, fixed sequence, two-period study will assess the effect of memantine on the~     pharmacokinetics, safety and tolerability of a single oral dose of RO5313534 and the effect~     of RO5313534 on safety and tolerability of steady-state memantine. Healthy volunteers will~     receive a single oral dose of RO5313534 on Day 1 of Treatment Period 1 (3 days). After a~     washout period of 5-21 days, oral memantine will be administered on Days 1-21 of Treatment~     Period 2 and a single dose of RO5313534 on Day 19. There will be a follow-up of 3-4 weeks~     after the last dose. Anticipated time on study for each volunteer is up to 14 weeks.~   "
180979|NCT01196052|"~     This single-arm open-label study assessed the safety, feasibility, and efficacy of~     trastuzumab emtansine (T-DM1) after the completion of anthracycline-based~     adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer.~     Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17~     cycles.~   "
180980|NCT01196039|"~     This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed~     to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to patients~     by intravenous (IV) infusion for the treatment of allergen-induced asthma.~   "
180981|NCT01196026|"~     This study is designed to assess the immunogenicity, reactogenicity and safety following~     vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been~     vaccinated with two doses of Pandemrix at the age of 6 months-9 years.~   "
180982|NCT01196013|"~     The purpose of this study is primarily to assess the safety, tolerability and~     pharmacokinetics (PK) of clofarabine intravenously administered to pediatric patients with~     relapsed or refractory acute lymphoblastic leukemia (ALL) or for whom no other therapy with~     greater potential clinical benefit exists. The dosing regimen for the intravenous (IV)~     clofarabine is 30 or 52 mg/m2/day for 5 consecutive days. The secondary objectives are to~     document the activity of clofarabine and to explore the impact of deoxycytidine kinase (dCK)~     promoter polymorphism on PK and treatment outcome.~   "
180983|NCT01196000|"~     RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for~     rectal cancer and may have fewer side effects and improve recovery. It is not yet known~     whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in~     treating patients with rectal cancer.~      PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see~     how well it works compared to laparoscopic surgery in treating patients with rectal cancer~     that can be removed by surgery.~   "
180984|NCT01195987|"~     The purpose of this study is to study the role of the Immune System in causing arthritis in~     patients with Hepatitis C.~   "
181002|NCT01195727|"~     CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in~     pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban~     in pediatric subjects with a central venous catheter.~   "
180985|NCT01195974|"~     This study is a two-period, double-blind study in healthy adult female subjects. Each subject~     will participate in an oral contraceptive Run-in period prior to the treatment periods. The~     length of the Run-in Period will be 28 days or longer, depending on the timing of the~     subject's menstrual cycle and on whether the subject is taking an OC. Each subject will~     participate in this run-in period (if needed), followed by two treatment periods. Treatment~     Periods 1 and 2 must be conducted successively. Subjects will be randomized in a cross-over~     fashion to either YASMIN with GSK2248761 or Placebo for 10 days and switch GSK2248761 or~     placebo for another 10 days. Subjects will return to the study center for final follow up~     evaluations 7 - 14 days after the final dose of study medication.~   "
180986|NCT01195961|"~     Background:~      - Developmental dyscalculia is a learning disability in which individuals have difficulty~     learning or comprehending mathematics or other number concepts (such as keeping score during~     games, measuring time, or estimating distance). Developmental dyscalculia affects certain~     parts of the brain that are required for processing numbers. Research has shown that a form~     of brain stimulation called transcranial direct current stimulation (tDCS), applied when~     healthy individuals are being trained to carry out tasks with numbers, improved the ability~     to process numbers and solve math problems. More research is needed about whether tDCS can~     improve number processing in people with developmental dyscalculia.~      Objectives:~      - To examine whether the effects of transcranial direct current stimulation can help~     individuals with developmental dyscalculia perform mathematical calculations.~      Eligibility:~      - Individuals between 18 and 50 years of age who have been diagnosed with developmental~     dyscalculia, or are healthy volunteers without dyscalculia.~      Design:~        -  Participants will have a screening visit and seven study visits. The screening visit and~          six of the study visits will take place consecutively over the course of 6 days, and the~          final visit will take place 3 months after the initial participation.~        -  Participants will be screened with a medical history, physical and neurological~          examination, and a brief examination to test for dyscalculia and determine the~          participant's dominant hand.~        -  Participants will be randomly assigned to one of two groups for the study. One group~          will receive tDCS during training to perform a task with numbers, and the other group~          will receive the same training with sham stimulation. Participants will not know which~          group they are in.~        -  During the study visits, participants will be trained on number tasks on 6 consecutive~          days. Before the tDCS or sham stimulation is applied at the beginning of the experiment~          and at the end of each training day, participants will perform other tasks with numbers.~          Participants will be evaluated based on the accuracy and speed with which they respond~          to the questions.~        -  At the followup visit, participants will perform the same number tasks they completed~          during the study visits. No tDCS will be performed at this visit.~   "
180987|NCT01195948|"~     Background:~      Uveitis is a serious inflammatory condition in which the body's immune system attacks parts~     of the eye, often causing vision loss. Uveitis treatments involve various drugs that suppress~     the immune system, but these medicines sometimes do not work or may cause serious side~     effects. Researchers are interested in developing new treatments for uveitis that are more~     effective and have fewer side effects.~      Optiquel® is an experimental medication being tested for its effectiveness against uveitis.~     It contains B27PD, a small protein fragment, which is similar to proteins in the parts of the~     eye being attacked by the immune system. Taking Optiquel® (B27PD) by mouth may induce oral~     tolerance, in which the immune system is taught to recognize and not attack normal parts of~     the human body.~      Objectives:~      To evaluate the safety and effectiveness of B27PD (Optiquel®) as a treatment for uveitis.~      Eligibility:~      Individuals at least 18 years of age who have had noninfectious uveitis in one or both eyes~     for at least 3 months, have vision of 20/200 or better in at least one eye, and are taking~     daily prednisone or an equivalent medication.~      Design:~      Participants will be screened with a physical examination, medical history, blood and urine~     tests, and an eye exam.~      This study will last a maximum of 52 weeks. During the first 12 weeks of the study,~     participants will have a study visit every 2 weeks. For the remainder of the study,~     participants will have a study visit every 4 weeks.~      Participants will have frequent blood and urine tests, and will also have eye examinations~     and special procedures (fluorescein angiography and indocyanine green angiography) to~     evaluate the effectiveness of the treatment.~      Participants will be randomly assigned into one of three groups and will receive either one~     of two different doses of B27PD or a placebo. During the study, participants will also have~     their dose of prednisone or other steroid medication reduced.~      Participants will take one capsule three times per week on Monday, Wednesday, and Friday, for~     a total of 24 weeks. Participants may take the capsule with water, but should not consume any~     other drinks or any kind of food until at least 30 minutes have passed to prevent stomach~     upset. The capsules should be stored in the refrigerator.~   "
180988|NCT01195922|"~     Background:~      - Advanced-stage head and neck cancer (head and neck squamous cell carcinoma [HNSCC]) has~     moderately successful treatment outcomes, usually involving surgery as part of the standard~     treatment. Researchers are investigating the use of the drug rapamycin to prevent tumor~     growth in HNSCC, and are interested in using it to treat individuals with HNSCC that has not~     been treated previously with other drugs, radiation, or surgery.~      Objectives:~      - To evaluate the usefulness of rapamycin in decreasing tumor size prior to surgery for head~     and neck squamous cell carcinoma.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with advanced head and neck~     squamous cell carcinoma that has not yet been treated.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          and imaging studies.~        -  Approximately 1 month before scheduled surgery, participants will begin to receive~          rapamycin. Participants will take rapamycin once daily for 21 days, followed by a 7-day~          period without the drug.~        -  During the 21-day rapamycin treatment, participants will have weekly study visits to~          provide blood and urine samples and have possible tumor biopsies and imaging studies~          such as x-rays or tumor photographs. Participants will have additional study visits for~          tests 1 day and 1 week after the end of rapamycin treatment, followed by HNSCC surgery.~        -  Participants will have a final visit to provide blood samples 30 days after surgery.~        -  Participants medical records will be reviewed 1 year after surgery; however,~          participants will not need to have further study visits at this time.~   "
180989|NCT01195896|"~     The investigation is designed as a prospective, open, non-controlled clinical investigation.~   "
180990|NCT01195883|"~     A trial in which patients having open abdominal surgery are randomized to receive either~     crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators~     test the primary hypothesis that goal-directed colloid administration during elective~     abdominal surgery decreases a composite of postoperative complications within 30 days of~     surgery.~   "
181003|NCT01195714|"~     This study is a multicentric, phase II, open-label, non-randomized trial evaluating the~     efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+~     diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a~     performance status ECOG from 0 to 4.~      The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort~     of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in~     Portugal).~      Patients will be recruited over 30 months and followed at least one year after the last~     patient has been included.~      The duration of the treatment period is approximately 20 weeks.~   "
181004|NCT01195701|"~     Women who are unable to achieve orgasm compared to women who have normal orgasmic function~     may have different clitoral anatomy and different hormone levels. The investigators~     hypothesis is that women who have difficulty with orgasm may have a clitoris that is closer~     to the vagina and may have higher testosterone levels. Pelvic MRI will be used to observe~     whether clitoral measurements differ between women with normal orgasmic function vs. those~     with anorgasmia.~   "
181005|NCT01195688|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 638683 in healthy male volunteers following oral administration of single rising doses~   "
180991|NCT01195870|"~     Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the~     nerves in within the brain and the spinal cord. This disease is one of the most common causes~     of disability in young adults. A ''relapse'' is a phenomenon that occurs when there is an~     acute attack of disability as a result of an acute attack on the nervous system. There is~     usually some degree of recovery after a relapse.~      Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3~     times a week by injections under the skin. The RebiSmart device is a new injection device~     which has been developed to help patients with injecting their Rebif treatment.~      Currently, all treatments for MS are injectable and require long term patient commitment.~     Patient compliance to treatment is important for the therapy to work effectively and decrease~     the risk of relapse episodes. Using a device that makes it easy for patients to inject may~     potentially improve compliance to treatment and therefore potentially have an impact on the~     number of relapses patients experience. The RebiSmart device has been developed for patients~     to inject conveniently and in comfort. The device allows the patient to control certain~     parameters such as needle depth, needle speed, injection time etc, and also has extra~     features designed to ease the injection process, such as a dose history calendar and an~     on−screen injection guide. The aim of this study is to determine what percentage of patients~     liked using the RebiSmart device and found it ''easy'' or ''very easy'' to use. The study~     will also determine which of the device features were most useful to the patients.~   "
180992|NCT01195857|"~     Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central~     nervous system (CNS) and is one of the most common causes of neurological disability in young~     adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is~     given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector~     which allows patients easier administration of their Rebif injections.~      Prior to treatment, patients receive training on the use of the device and its maintenance.~     Currently, all treatments for MS are injectable and require long term patient commitment.~     Rebiject has been developed to improve patient convenience and comfort but does require~     multiple steps to be carried out in order for the injection to be delivered correctly.~     Reports from our local call centre and nurse advisors suggest that inaccuracies of use with~     the Rebiject device are common. By raising awareness of the level of inaccuracy and~     determining which steps patients are most likely not to complete correctly, modified training~     programs or modifications to current subject training may be put into place to address these~     issues. It is also important to demonstrate the link between poor use of the medication~     device and increased relapse rates or increased injection site reactions.~   "
180993|NCT01195844|"~     This is a 1-year study evaluating hospitalizations and the medical care for the treatment of~     diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals~     located in four Brazilian regions. A stool sample from each eligible child passing 3 or more~     loose stools or watery stools within a period of 24 hours and requiring hospitalization or~     rehydration therapy (oral or IV rehydration) will be tested for the presence of rotavirus,~     using standard laboratory procedures (ie, Enzyme Linked Ligand Sorbent Assay, or ELlSA) by~     all participating hospitals.~   "
180994|NCT01195831|"~     The purpose of this study is to compare the clinical efficacy of once daily treatment for 4~     weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4~     weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.~   "
180995|NCT01195818|"~     The prevalence of Sickle Cell Associated Nephropathy (SCAN) is increasing and is a growing~     concern. Microalbuminuria is detected in the early onset of SCAN. Noteworthy, as in diabetic~     nephropathy, hyperfiltration seems to be a frequent finding, with, in our series, an overall~     incidence of 57 % and suggests a pathological links between glomerular hyperpressure and~     glomerulosclerosis which occurs several years after. Nitric oxide (NO) deficiency and the~     renin angiotensin system (RAS) are likely to be involved in the glomerular hyperpressure~     leading to hyperfiltration. Renin angiotensin antagonists are currently given for~     NEPHROPROTECTION in numerous nephropathy including SCAN despite few available reports. The~     percentage of decrease of albuminuria or the percentage of responders (ie patient normalizing~     albuminuria) has never been reported to our knowledge in SCAN patients at the time of~     hyperfiltration. The focus of our study is therefore to 1) Quantify albuminuria reduction~     after 6 months RAS treatment (primary end point); 2) Quantify glomerular filtration rate~     (GFR) reduction after 6 months of RAS treatment, and to test the hypothesis of a beneficial~     effect of RAS inhibitors on several biomarkers assessing hemolysis, NO inhibition and the~     endothelial damages (secondary end points). The ultimate aim of our study is to identify~     relevant (new) biomarkers associated to hyperfiltration and/or albuminuria decrease~     (/normalization).~   "
180996|NCT01195805|"~     The investigators wish to study the effect of retaining potassium. The participants have~     essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The~     participants will ingest tablets for 28 days before being examined. We will perform a 24~     hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we~     also examine the patient using a SphygmoCor.~   "
180997|NCT01195792|"~     The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese~     but otherwise healthy subjects with over-eating behaviours.~   "
180998|NCT01195779|"~     The purpose of this observer-blind study is to evaluate the safety and immunogenicity of~     GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months~     of age.~   "
180999|NCT01195766|"~     The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome~     patients that have a first line chemotherapy treatment failure due to refractoriness, partial~     response or relapsed.~      In the same way, mortality, global survival and free-progression survival after O-ESHAP~     treatment and TAPH will also analyzed.~   "
181000|NCT01195753|"~     Treatment with liver cell infusion for children with urea cycle disorders (UCD).~   "
181001|NCT01195740|"~     Few empirically-based treatment models exist for adolescent suicide attempters post~     psychiatric hospitalization, despite the fact that managed care has limited the role of~     hospitalization to stabilization, rather than remission. This study will test the efficacy~     and initial outcomes of Attachment Based Family Therapy (ABFT) as an aftercare model to~     further gains made in inpatient treatment and reduce risk factors for future suicide~     attempts.~   "
181008|NCT01195649|"~     The primary objective of this prospective, observational, post-marketing study is to evaluate~     the patient characteristics, pre-treatment and treatment duration in Renal Cell Carcinoma~     (RCC) patients who are candidates for systematic therapy and in whom a decision to treat with~     Nexavar® has been made under real-life practice settings and approved reimbursement~     restriction in Taiwan. Therefore, the main objective of the study is to collect data on:~      Prescription pattern: to determine the factors affecting compliance and duration of treatment~     with special attention given to education status, demography, disease details, pre-treatment,~     concomitant medication and other baseline data~      Nexavar® treatment and efficacy data~      Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0~   "
181009|NCT01195636|"~     The purpose of this trial is to determine if XPF-002 is safe and effective for the treatment~     of pain in subjects with Postherpetic Neuralgia~   "
181010|NCT01195623|"~     Duplex imaging is costly and time-consuming, but is used increasingly for preoperative~     evaluation of varicose veins. Its value in terms of the long-term results of surgery is not~     clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with~     or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were~     compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led~     to an improvement in results. However two years is a short time, and with a longer follow-up~     other mechanisms for recurrence may become more important, e.g. neovascularization (new~     vessel formation) or progression of disease, hence the value of a detailed preoperative~     diagnosis may be diminished. The aim of this phase of the investigation is to study the~     results after 8 years, in particular what mechanisms for recurrences were most important.~   "
181011|NCT01195610|"~     The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet~     (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can~     improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and~     cardiovascular diseases.~   "
181012|NCT01195597|"~     The study's major aim is to investigate the ability of a commercial Electronic Nicotine~     Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling~     to quit. Secondary aims are to monitor adverse events and measure participants' perception~     and acceptance of the product.~      This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and~     adverse events of a currently marketed device in Italy (Categoria electronic cigarette -~     ORIGINAL 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a~     safe device that allows smoking reduction or abstinence in smokers.~   "
181013|NCT01195584|"~     The study concerns a retrospective analysis of all subjects operated as of 1st Jan 2008 using~     Minimal Access Surgical Technique (MAST). The study is descriptive in nature and will present~     the observation of all cumulated patients operated with MAST.~      The study data will include the general health information of the subjects prior to surgery,~     information on the surgery such as OP time, blood loss, and the postoperative wound healing~     process (until discharge), which is on average the 10th postoperative day.~   "
181014|NCT01195571|"~     The purpose of this research study is to test the safety and tolerability of four new~     investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male~     volunteers who are CMV negative. CMV is a common virus, infecting 50-80% of adults in the~     United States by the age of twenty-one. CMV does not usually cause illness in adults or~     children. However, CMV can be a cause of deafness and mental retardation in a child if a~     mother is infected during pregnancy. It also can be a serious illness in patients with~     impaired immunity (decreased ability to fight infection).~   "
181015|NCT01195558|"~     Non-24-hour sleep-wake disorder (Non-24) is a condition experienced primarily by totally~     blind individuals that results in abnormal night sleep patterns and chronic daytime~     sleepiness. This is a research protocol to develop a patient registry of subjects who may~     suffer from Non-24 and who are blind. Subjects participate in the study through a phone~     survey. This registry will be used to better understand, sleep related problems in blind~     individuals, including the investigation of a potential treatment, recruitment for future~     clinical studies, and to provide a forum for raising awareness about Non-24. The survey~     consists of questions regarding the degree of vision impairment and sleep problems that the~     subjects may be experiencing.~   "
181016|NCT01195545|"~     This is an investigator initiated pilot study to observe the short-term outcomes (a follow-up~     period of up to six months) of patients who undergo a laparoscopic paraesophageal Hiatal~     hernia (PEH) repair using the Veritas® Collagen Matrix brand biological mesh. This is a~     preliminary study at the University of Washington.~      A PEH occurs when the stomach protrudes through the diaphragm next to the esophagus. The~     chance of recurrence of a Hiatal hernia after laparoscopic PEH repair is between 20-40%~     within 6 months.During laparoscopic PEH repair, a mesh-type product is used as a scaffold.~     The mesh serves as a reinforcing material during the surgical repair. It is cut to the~     appropriate size needed for the hernia and sutured to the surrounding diaphragmatic tissue.~     There are many different types of meshes available on the market, and vary in the degree of~     manageability, strength, and adherence.~      Although surgical meshes work on the same principal, the variance between materials may~     affect patient outcomes. There is evidence that a biologic mesh, specifically one derived~     from Small Intestinal Submucosa (SIS), decreases the short-term (6-month) recurrence rates~     compared to a synthetic mesh or another type of biologic mesh. A biologic mesh, serving as a~     scaffold, will be replaced by the patient's own tissue after about 6 months. Theoretically,~     this would prevent the possible complications associated with synthetic mesh including mesh~     erosion into the esophagus or stricture of the esophagus.~      There are some case series showing similar short-term results between the different biologic~     meshes, but there is no direct comparative data.~   "
181017|NCT01195532|"~     The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different MR~     tablets of gliclazide after single oral administration at the same doses to healthy subjects.~   "
181018|NCT01195519|"~     Currently, lots of researches aimed at quality of life of patients with peritoneal dialysis~     and hemodialysis related issues. There is no study related to establish the predictive model~     of quality of life. This study will investigate the predictive model of quality of life in~     terms of peritoneal dialysis (PD) or hemodialysis (HD) patients. These results will offer the~     further evidence to the government to develop the effective interventions for dialysis~     patients. The optimal goal is to promote the quality care.~   "
181019|NCT01195506|"~     Vascular endothelial growth factor (VEGF)-C is recognized as a tumor lymphangiogenic factor~     based on the effects of activated VEGFR3 on lymphatic endothelial cells. VEGFR3 has been~     proposed as a specific marker for lymphatic endothelial cells. Recent studies indicated that~     VEGFR3 also expressed in a variety of human malignancies, including lung, colon rectal, or~     head and neck cancer. Moreover, VEGF-C/VEGFR3 axis was demonstrated in regulating~     angiogenesis, cell invasion, and metastasis in several solid tumors. The promotion of cell~     mobility in response to VEGF-C was required the involvement of adhesion molecule contactin-1.~     In addition to solid tumors, it has been reported that the VEGF-C/VEGFR3 axis is activated in~     subsets of leukemia patients. Until now, it has been demonstrated that higher endogenous~     VEGFC levels of acute myelogenous leukemia (AML) cells are related to decreased in vitro and~     in vivo responsiveness to chemotherapy; an effect that may result from inhibition of~     apoptosis by increasing Bcl-2/Bax ratios by the VEGF-C/VEGFR3 pathway. Thus, a functional~     VEGF-C/VEGFR3 system may exist in leukemia. However, the detail information concerning the~     role of VEGF-C/VEGFR3 in non-solid tumors is still lacking. Bone marrow neoangiogenesis plays~     a crucial pathogenic and possible prognostic role in AML. The VEGF-C/VEGFR3 axis has been~     proven in the regulation of solid tumors angiogenesis. In the investigators preliminary~     study, the investigators found VEGF-C may play a critical role in angiogenesis regulation of~     leukemic cells by upregulating cyclooxygenase-2 (COX-2). Furthermore, the investigators found~     that the upregulation of COX-2 also correlate with the VEGF-C-induced proliferation in~     leukemic cells and this phenomenon might further regulate the chemoresistance of VEGF-C. In~     this study, the investigators will investigate the extent of angiogenesis and chemoresistance~     induced by VEGF-C in leukemic cells. This study will provide evidences on the subject of the~     novel role of VEGF-C in leukemia. With progress in molecular biology of VEGF-C, its value as~     a therapeutic target is highly promising.~   "
181020|NCT01195493|"~     Chronic periodontitis is a common infectious disease characterized by progressive attachment~     loss and alveolar bone resorption eventually resulting in tooth loss. The ultimate goal of~     periodontal therapy is to prevent this endpoint. At least when a strict supportive care~     program is implemented following active therapy, subsequent tooth loss is limited to a mean~     of about 0.1 per patient per year. In contrast, three to six times as many teeth may be lost~     if the disease is left untreated.~      The objective of supportive care is to prevent disease recurrence, which is accomplished by~     strict home care and professional plaque control at regular intervals depending on the~     patient's needs. Evidently, not all patients are optimally compliant in terms of plaque~     control. Therefore, chemical aids could be administered to supplement mechanical plaque~     removal.~      Essential oils solutions containing menthol, thymol, methyl salicylate and eucalyptol as~     active agents may be more appropriate to supplement daily home care. Clinical studies have~     shown an additional anti-plaque and anti-gingivitis effect over mechanical plaque control~     without relevant side effects in healthy subjects and gingivitis patients.~      Recently, significant reductions of periodontopathogens in the subgingival biofilm have been~     shown in periodontitis patients following subgingival irrigation using an essential oils~     solution. In addition, mouthrinsing on a daily basis seemed to substantially alter the~     subgingival microflora towards a less pathogenic one in gingivitis and periodontitis~     patients. Even though these are interesting findings, they should be considered exploratory~     since they relate to a small number of patients observed for only two weeks.~      The goal of the present study was to thoroughly document the clinical and microbiological~     effects of an essential oils solution used on a daily basis for 3 months as an adjunct to~     mechanical plaque control measures in a large number of chronic periodontitis patients in~     supportive care.~   "
181021|NCT01195480|"~     The aim of this clinical trial is to evaluate the feasibility, safety and biological effect~     of adoptive transfer of CD19ζ chimaeric receptor transduced donor-derived EBV-specific~     cytotoxic T-lymphocytes (EBV-CTL) in patients with high-risk or relapsed B cell precursor ALL~     after allogeneic Haematopoietic Stem Cell Transplantation (HSCT).~   "
181022|NCT01195467|"~     The purpose of the study is to investigate the benefits of switching away from efavirenz~     (part of the combination pill, Atripla®) in patients with central nervous system side effects~     (such as insomnia {difficulty with sleeping}, bad dreams etc). The investigators will~     investigate the effect of switching to Truvada (a combination pill of tenofovir and~     emtricitabine, the other two components of Atripla) plus raltegravir.~      Raltegravir is a licensed drug for HIV treatment which showed side effects were fewer in~     number when compared to efavirenz in 2 other clinical studies, where patients were starting~     HIV treatment for the first time.~      This study will also investigate the safety (in terms of other side effects and the routine~     blood tests which the investigators ordinarily use to monitor your treatment) and monitor~     effectiveness, your viral load and CD4 counts, when you switch treatment from Atripla® to~     Truvada/raltegravir.~   "
181023|NCT01195454|"~     Primary Objective:~      - To assess the total metabolic effect ratios of a new insulin glargine formulation versus~     Lantus®~      Secondary Objectives:~        -  To assess the exposure ratios of a new insulin glargine formulation versus Lantus®~        -  To compare the duration of action of a new insulin glargine formulation versus Lantus®~        -  To explore the dose response and dose exposure relationship of a new insulin glargine~          formulation~        -  To assess the safety and tolerability of a new insulin glargine formulation~   "
181024|NCT01195441|"~     The purpose of this study is to determine whether the Fetal Medicine Foundation algorithm for~     individual risk calculation for preeclampsia (PE) and pregnancy induced hypertension (PIH) is~     suitable to identify women in high risk of developing these diseases in a Norwegian~     population.~   "
181025|NCT01195428|"~     Acute Lung Injury/Acute respiratory distress syndrome (ALI/ARDS) is a serious and frequently~     encountered entity in modern ICUs. Sepsis remains the most common cause of ALI/ARDS and~     carries the worst prognosis. The disease is characterized by an intense inflammatory process.~     This inflammation plays a major role in the development of gas exchange abnormalities seen in~     the course of the disease. Statins, primarily used as lipid-lowering agents, are now known to~     possess anti-inflammatory, antioxidant, antithrombogenic and vascular function-restoring~     actions. Therefore the investigators propose to determine if Simvastatin may be useful in~     decreasing the incidence of this deadly syndrome in critically ill patients.~   "
181026|NCT01195415|"~     This pilot clinical trial studies vismodegib and gemcitabine hydrochloride in treating~     patients with advanced pancreatic cancer. Vismodegib may stop the growth of pancreatic cancer~     by blocking blow flow to the tumor. Gemcitabine hydrochloride may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving vismodegib and~     gemcitabine hydrochloride may kill more tumor cells.~   "
181027|NCT01195402|"~     This randomised-controlled study is undertaken to investigate the effects of a long term low~     intensity outpatient training program on physical fitness and quality of life in moderate to~     severe COPD patients.~   "
181028|NCT01195389|"~     The purpose of this study is to determine if low level magnetic fields can help to improve~     memory in patients diagnosed with Alzheimer's dementia.~   "
181029|NCT01195376|"~     In this study, BEZ235 will be administered to adult patients with advanced solid tumors whose~     disease has progressed despite standard therapy or for whom no standard therapy exists. The~     trial will confirmed the safety and tolerability and determine the MTD of BEZ235 in Japanese~     patients.~   "
181030|NCT01195363|"~     To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment~     with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three~     thereof, in a group of patients with an index episode of a mixed state in BD.~   "
181031|NCT01195350|"~     Stroke is the leading cause of mortality in Brazil. Strict blood pressure control in chronic~     phase is the major measure to primary and secondary prevention, but in acute phase is not~     clear the best blood pressure level. Few studies demonstrate a U relationship between blood~     pressure and lethality; nevertheless any Brazilian study has addressed this issue.~      This is a prospective observational study on the relationship between BP and mortality in the~     acute phase of stroke. The study will be conducted in the Adult ICU of HC-UNESP. Will be~     analyzed 266 patients aged 18 years and of both sexes admitted to the ICU with a diagnosis of~     hemorrhagic and ischemic stroke. Participants will be divided into three groups according to~     the initial PA present:~      Group A: Patients with systolic BP of entry below 140 mmHg; Group B: Patients with systolic~     BP of entry between 140 and 180 mmHg; Group C: patients with systolic BP greater than 180~     mmHg entry. Multiple logistic regression analysis will be done to verify the association of~     blood pressure and lethality adjusted to confounding variables.~   "
181032|NCT01195337|"~     The goal of this study is to learn why some black and Latino men and women choose not to~     exercise very often. Researchers also want to learn more about any social and environmental~     factors that may affect the way an exercise program is followed.~   "
181033|NCT01195324|"~     The purpose of the study is to assess the effect of multiple oral doses of canagliflozin on a~     single oral dose of warfarin.~   "
181034|NCT01195311|"~     This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360~     (study drug) is safe, well-tolerated and effective in patients with advanced malignancies.~     Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28~     days before the next group is enrolled and may begin to receive study drug. For subject~     safety, the first subject in each cohort will be administered drug for one week before the~     next two subjects in the cohort can begin drug administration. Doses will be escalated unless~     a dose-limiting toxicity (DLT) is observed in one of three subjects.~      An expanded cohort of up to 15 patients may be recruited to further explore safety at the~     'maximum tolerated dose' or at a lower, pharmacologically active, dose.~   "
181035|NCT01195298|"~     This is an open-label, single-arm, multicenter study of capecitabine and bevacizumab~     administered as first-line treatment of previously untreated elderly patients, older than 70~     years, with metastatic or locally recurrent breast cancer.~   "
181036|NCT01195285|"~     This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to~     traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and~     cost.~   "
181037|NCT01195272|"~     This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab)~     on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients~     with active rheumatoid arthritis who have an inadequate response to current biologic or~     non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive~     RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or~     in combination with their current non-biologic DMARD. Anticipated time on study treatment is~     52 weeks.~   "
181038|NCT01195259|"~     Observational analyses of data from population registeries have suggested that metformin may~     be associated with a decreased prevalence of malignancy. The ADOPT and RECORD studies both~     contain groups of subjects randomly allocated to metformin and rosiglitazone. This~     meta-analysis combines malignancy serious adverse events from ADOPT and RECORD in order to~     compare their incidence on metformin with that on rosiglitazone.~   "
181039|NCT01195246|"~     The purpose of this study is to compare the immune response to HEPLISAV™ booster injection~     with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with~     end stage renal disease (ESRD) on hemodialysis.~   "
181040|NCT01195233|"~     The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of~     radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam~     Khomeini Hospital.~   "
181041|NCT01195220|"~     Project Aware introduces a sexually transmitted infection (STI) screening model for sexually~     experienced adolescents aged 14 to 21 in a large, inner-city Emergency Department (ED) in the~     Bronx, N.Y. Project Aware will scaffold routine, rapid testing and counseling for Chlamydia~     trachomatis (CT) and Neisseria gonorrhoeae (GC) onto an existing, successful, ED-based HIV~     testing and counseling program, Project BRIEF. Project Aware will educate and motivate youth~     to use condoms with the aid of a theory-based, youth-friendly multimedia behavioral~     intervention proven to be effective during the investigator's K23 training. Through Project~     Aware, the investigators propose to change the paradigm of STI testing. Whereas a view of~     HIV exceptionalism has persisted in U.S. health policies on STI testing, the investigators~     propose a comprehensive approach, in which efforts to identify, treat, and prevent multiple~     STIs coalesce in one program. The research study has two phases. In the production phase, new~     STI material will be added to the multimedia intervention currently used for HIV education.~     In the evaluation phase, a randomized controlled trial (RCT) will be conducted to assess the~     effectiveness of Project Aware in identifying, treating, and preventing new STI infections~     among high-risk adolescents. The RCT is designed to test the incremental effectiveness of~     three STI prevention methods: (1) HIV testing and counseling (T&C), (2) HIV T&C and STI~     testing, and (3) HIV/STI Testing plus a point-of-service risk reduction video that~     incorporates both HIV and STI counseling and education. The study is powered to examine three~     STI prevention outcomes: (1) the number of STI infections identified and treated successfully~     at baseline; (2) the number of new STI infections over the 12 months following study entry,~     identified by (a) performing STI testing at each follow-up assessment; and (b) obtaining~     anonymized rate data on STIs reported to the New York City Department of Health; (3) condom~     use behavior. 600 youth aged 14-21 will be enrolled in the RCT. Youth will be approached in~     the ED waiting room and recruited by Public Health Advocates. All will complete a survey to~     screen for eligibility; eligible youth will complete the baseline measures and be randomized.~     The follow-up data points and measures will be followed at 4, 8 and 12 months (4 time points)~     and STI testing will be included.~   "
181042|NCT01195207|"~     This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.~   "
181043|NCT01195194|"~     The objective is to assess if low pre-transplantation donor specific T-cell reactive patients~     measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with~     Calcineurin inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.~   "
181067|NCT01194869|"~     The purpose of this study is to identify new treatment regimens with better response rates~     and to find out if the combination of cisplatin and sorafenib followed by paclitaxel and~     sorafenib can shrink the size of your breast tumor and allow you to preserve your breast.~     Sorafenib is a newer drug that targets blood vessel formation and may help the chemotherapy~     work better. Additionally, by receiving chemotherapy before surgery, we will be able to~     determine if your cancer is responsive to chemotherapy.~   "
181196|NCT01193127|"~     The purpose of this study is to determine whether the use of OMS302 (the study drug) in~     individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and~     effective at maintaining an adequately dilated pupil during surgery and reducing~     post-operative symptoms of discomfort (such as eye pain and irritation).~   "
181044|NCT01195181|"~     Hepatitis C virus (HCV) infection provokes thousands of deaths every year all over the world,~     being the major cause of progressive liver disease, primary hepatic cancer and liver~     transplantation. Today, a curative therapy is available, that can eradicate the viral~     infection and determine the regression of liver fibrosis, also in cirrhotic subjects.~      The current standard-of-care for HCV chronic infection is combination therapy with~     peginterferon (P-IFN) and ribavirin (RBV). However, this treatment is not only expensive but~     determines several side effects, that can reduce drug tolerance and hence, patient adherence~     to therapy. There are two types of available P-IFN on the market: P-IFN alfa-2a (Pegasys®,~     F.Hoffmann-La Roche) administered at a flat-dose of 180 mcg/week and P-IFN alfa-2b~     (PegIntron®, Schering-Plough) given at a weight-based dose of 50 to 150 mcg/week. Since only~     a single amino acid differentiates these types of IFN, administration strategies depend on~     their pegilation with molecules of 40 or 12kDa, respectively, that accounts for differences~     in the pharmacokinetic and pharmacodynamic drug-profile and influences probably also~     bioactivity. No comparative data are available on the benefits and costs of the licensed~     Peg-IFN plus RBV for the treatment of HCV infection in the real clinical practice, even if,~     the benefit and favourable cost-efficacy of this antiviral therapy is well established and of~     large consensus. Recently, the first randomized controlled mega-trial to compare antiviral~     therapeutic efficacy in naïve patients with HCV-genotype 1 infection during different~     regimens of P-IFN alfa-2b (at low and standard-dose) and P-IFN alfa-2a plus RBV, has been~     published, confirming a similar efficacy, of around 40%, obtained with the three schedules~     evaluated.~      In Italy, a regional program on the Surveillance and Control of HCV Infection, set up by the~     Regional Health Councillorship, has led to the development of a clinical and epidemiological~     observatory, constituted by a network of liver tertiary centres (Hepatological Cooperative~     Network of Veneto, HepCoVe). This collaborative group is connected on-line by a common~     database that, since 2003, has prospectively collected data on a cohort of more than 3000~     patients with chronic HCV infection and, among them, of 506 naïve subjects that consecutively~     underwent combination therapy with P-IFN alfa-2a or alfa-2b plus RBV.~      The aim of this study was to rationalize and improve the social regional health program on~     antiviral treatment of chronic hepatitis C by assessing the different schedules utilization~     of P-IFN plus RBV as well as the respective therapeutic effectiveness, safety and costs in~     the real clinical practice (Project A).~   "
181045|NCT01195168|"~     Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more~     insulin resistant than women without the condition and may be at greater risk of developing~     cardiovascular disease. It is not know whether it is the overweight and insulin resistant~     component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The~     aim of this study was to examine cardiovascular risk markers in women with PCOS versus a~     control population matched for body mass index (BMI), and or, insulin resistance~   "
181046|NCT01195155|"~     Adipose tissue is a central organ involved in mediating metabolic health, and so the~     investigation of treatments which improve adipose tissue function is warranted. LC n-3~     polyunsaturated fatty acid (PUFA) have been shown to exert positive effects on adipose tissue~     gene expression in previous studies. However this has not been investigated in women with~     polycystic ovary syndrome (PCOS), a population shown to display a degree of adipose tissue~     dysfunction. The aim of this study was to determine the impact of LC n-3 PUFA supplementation~     on gene expression profiles of women with PCOS.~   "
181047|NCT01195142|"~     Adipose tissue is a central organ in mediating metabolic health. There is some evidence that~     women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which~     may negatively affect their metabolic health. The aim of this study was to assess~     transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with~     a control population matched on the basis of age and body mass index (BMI). A secondary aim~     was to then relate these gene expression profiles to the biochemical environment.~   "
181048|NCT01195129|"~     The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil~     aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.~   "
181049|NCT01195116|"~     The purpose of this study is to assess the effects of dexmedetomidine while patients undergo~     treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in~     patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a~     supplemental anesthetic agent will result in better postoperative pain management.~   "
181050|NCT01195103|"~     How does Lusedra compare with current standard of care (midazolam) for minimal to moderate~     sedation for regional anesthesia blocks prior to orthopedic surgery?~   "
181051|NCT01195090|"~     This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with~     pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite~     dual therapy with metformin and a sulfonylurea.~   "
181052|NCT01195077|"~     Drawing inferences from epidemiologic studies of HIV/AIDS as well well as cell culture and~     animal studies of HIV inhibition by algae, we propose algal consumption as one unifying~     characteristic of countries with anomalously low rates. HIV/AIDS incidence and prevalence in~     Eastern Asia (<1/10,000 adults in Japan and Korea), compared to Africa (≈1/10 adults)~     strongly suggest that differences in IV drug use and sexual behavior are insufficient to~     explain the 1000-fold variation. Even in Africa, AIDS/HIV rates vary. Spirulina is part of~     the daily diet for many people living in Chad, where prevalence of HIV has remained at less~     than 4% for more than 20 years. Average daily algae consumption in Asia and Africa ranges~     between 1 to 2 tablespoons (3 - 13 grams).~      HIV viral load is the main indicator of infection, however CD4 helper cell counts are most~     predictive of morbidity and mortality.We hypothesized that the consumption of algae could be~     important in diminishing the risk of HIV infection, and subsequent progression, possibly by~     enhancing the immune response.~   "
181053|NCT01195064|"~     The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary~     disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function,~     before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a~     cardiovascular surgery, by an observational physiological study.~      An interim analysis will be performed when 100 patients will be included.~   "
181054|NCT01195051|"~     This study addresses the problem of inadequate medication reconciliation as patients cross~     boundaries between inpatient and outpatient care (ambulatory care). The purpose of this study~     is to determine whether a new, computer-based application, integrated with electronic~     prescribing, improves erroneous discrepancies between pre-hospital medications and~     medications upon patients' return to ambulatory care.~   "
181055|NCT01195038|"~     The study is designed to assess the immunogenicity and safety of one booster vaccination with~     45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young~     adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1~     influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).~   "
181079|NCT01194674|"~     The objective of this study is to investigate the safety and efficacy of microplasmin as a~     treatment for uveitic macular edema.~   "
181056|NCT01195025|"~     Volume kinetics is a method mostly used, so far, to study the distribution and elimination of~     crystalloid solutions. Voluven (in Sweden the most commonly used colloid for replacement of~     bleeding during surgery) is poorly studied, though. Also, a recent study showed unexpected~     volume kinetics for a crystalloid solution when it was given after a colloid solution. The~     investigators aim to study the volume kinetics of crystalloids and colloids and also the~     combination of the two in more detail. The investigators will also compare the invasive~     hemoglobin measurements with measurements from a new non-invasive tool (Radical 7, from~     Masimo Inc.) which could help to make volume kinetics more practical for everyday use.~     Finally the investigators will also study the concentrations of a few coagulation factors to~     see if they can explain the variations in coagulability that has been described in earlier~     studies of infusion solutions.~   "
181057|NCT01195012|"~     This is a feasibility study to evaluate a 6-month obesity treatment intervention (Helping~     HAND: Health Activity and Nutrition Directions) for pediatric primary care clinics. The~     program targets 5-8 year old children and their parents to change the child's lifestyle~     behaviors and the associated parenting practices to improve the child's weight status. Four~     community clinics participated. Families were recruited from clinics and after informed~     consent and baseline data have been obtained, the families were randomized into one of two~     groups: (1) the treatment group who immediately participated in Helping HAND or (2) the wait~     list control group, who started the program 7 months later. Data were gathered on all the~     participating children and their parents at three time points: baseline, post the~     intervention (month 7) and post the wait list control group completing the intervention~     (month 14).~      This was a pilot study to test the feasibility of an obesity prevention plus program~     delivered in the child's primary care clinic. The primary outcome was family attendance to~     the 3 data-collection meetings with research staff and the 6 prevention plus intervention~     sessions with a trained Health Advisor.~   "
181058|NCT01194999|"~     Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by~     strenuous events such as child birth. A common purported side effect of PVS is urgency, the~     feeling of a compelling need to void with little warning. Other overactive bladder (OAB)~     adverse effects that some claim to develop post-op include further leakage (incontinence),~     frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however,~     suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be~     alleviated by said procedure. It is our aim to investigate this relationship in our clinic.~      As a prospective member of this study, you will be asked to complete five surveys. The first~     survey will be administered prior to your pubovaginal sling. This will be used to establish~     your baseline experience of OAB. Over the course of the next year, you will be asked to~     complete the four remaining surveys at regularly scheduled check-ups.~   "
181059|NCT01194986|"~     The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how~     much AZD5213 displaces radioligand from histamine receptors when given together.~   "
181060|NCT01194973|"~     The record Primary purpose is to assess the efficacy of eculizumab in adult patients with~     Atypical Hemolytic- Uremic Syndrome (aHUS) to control Thrombotic Microangiopathy (TMA) as~     characterized by thrombocytopenia, hemolysis and renal impairment.~   "
181061|NCT01194960|"~     Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer~     vaccine before chemotherapy to enhance immune responses, thus leading to a more effective~     therapeutic approach for subjects with metastatic HRPC. This clinical study will evaluate the~     role of combination therapy of TroVax® plus Docetaxel vs. Docetaxel alone on the progression~     free survival (PFS) of subjects with HRPC.~   "
181062|NCT01194947|"~     Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct~     subsets of melanocytic nevi that retain their distinctive pattern over time.~   "
181063|NCT01194934|"~     This is the second clinical study of NOX-A12. This study intends to provide information on~     the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated~     intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of~     hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination~     with filgrastim in healthy subjects. A single center, open-label, repeated dose study design~     is selected to best address the study objectives.The results from this study will establish~     the basis for further development of NOX-A12 in lymphoma patients undergoing autologous~     hematopoietic stem cell transplantation~   "
181064|NCT01194908|"~     Patients are being asked to take part in this study because they have metastatic breast~     cancer that is triple negative (does not express estrogen receptor (ER), progesterone~     receptor (PR) or HER2). This means that agents such as trastuzumab (Herceptin®) and tamoxifen~     are not currently treatment options for their cancer. Another option for treating the~     patient's cancer at this point is with chemotherapy. The patient should discuss this and~     other options with their doctor prior to entering this study.~      Laboratory studies have demonstrated that ER is actually present in some triple negative~     breast cancers but is silenced (does not function properly) because methyl and histone~     groups are attached to it and inactivate it. Special drugs called demethylating inhibitors~     (such as decitabine) and histone deacetylase inhibitors (such as LBH589) can remove these~     methyl and histone groups and reactivate ER. This reactivated ER can then be targeted with~     agents like tamoxifen.~      The patient is being asked to join this clinical research study to find out if ER can be~     reactivated in their cancer using decitabine in combination with LBH589. If ER is reactivated~     in their cancer, we will then determine if tamoxifen can decrease the growth of the cancer.~   "
181065|NCT01194895|"~     The purpose of this trial is to determine whether low tidal volume during intraoperative~     one-lung ventilation could decrease the incidence rate of postoperative acute lung injury~     compared to normal tidal volume.~   "
181066|NCT01194882|"~     Primary Objective:~      To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump~     refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess~     efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml~     group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative~     phase).~      Secondary Objective:~      To assess efficacy, safety, refill accuracy evolution and device interventions during the~     open-label treatment period with Insuman To evaluate daily insulin doses To assess~     Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases~   "
181068|NCT01194856|"~     The purposes of this study are to evaluate if switching an antiretroviral medication from~     efavirenz (EFV) to atazanavir/ ritonavir (ARV/r) will, in a 96-week period, change:~        1. the amount of fat in HIV patients with lipoatrophy,~        2. metabolic lab values such as your lipid (fat) profile, glucose (blood sugar), and~          insulin (a hormone that regulates glucose) in HIV patients with lipoatrophy.~   "
181069|NCT01194843|"~     The purpose of the study is to evaluate the efficacy and impact on morphine consumption of~     ropivacaine administered by local per and post hepatic surgery infiltration.~      Patients will be randomized to either ropivacaine or physiological serum, with equivalent~     administration modalities in both arms.~      Patients will be followed during 4 days after the surgery. They will also come back for a~     follow-up visit one month later.~      It is necessary to enrol 100 patients. The estimated period of inclusion is 24 months.~      This is a prospective, comparative, monocentric, double-blind randomized study.~   "
181070|NCT01194830|"~     Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT~     sub-study~   "
181071|NCT01194817|"~     The purpose of this study is to compare the the Nexgen knee replacement system using~     cementless fixation with the same system using cemented fixation. At minimum 2-year~     follow-up, the hypothesis is that NexGen total knee arthroplasties using cementless and~     cemented fixation will demonstrate no differences in clinical outcome based on Oxford and~     Knee Society scores, patient-assessed visual analog pain, clinical complications,~     radiographic fixation and implant survivorship.~   "
181072|NCT01194804|"~     The objective of this study is to assess the long term safety of Eculizumab in hemolytic PNH~     patients who completed the 4 weeks screening and 12 weeks treatment period of C07-001 study.~     In addition, pharmacokinetic and pharmacodynamic assessments of Eculizumab will be conducted.~   "
181073|NCT01194791|"~     Primary outcome measure:~      - Hematologic response rate to the association of Lenalidomide, Cyclophosphamide and~     Dexamethasone.~      Secondary outcome measures:~        -  Organ response rate.~        -  Predictors of response (cardiac biomarkers, serum free light chains).~        -  Toxicity~        -  Safety (type, frequency, severity and relationship of adverse events to the study drug).~        -  Duration of response.~        -  Time to progression.~        -  Overall survival~   "
181074|NCT01194778|"~     Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green~     vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher~     menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Nothing is known yet~     about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of~     essential proteins). Therefore, this study was undertaken to study effects of different~     dosages of bacterial vitamin K2 on carboxylation of extrahepatic proteins.~   "
181075|NCT01194765|"~     Anxiety disorders are common pervasive conditions with serious psychosocial implications.~     Anxiety sensitivity (AS) is one individual characteristic that has been implicated in the~     onset and maintenance of anxiety disorders (Schmidt et al., 1999). AS is an enduring fear of~     anxiety-related arousal sensations (i.e., increased heart rate) that arises from the tendency~     to interpret these sensations catastrophically, believing that they will have serious~     physical, psychological, or social consequences (Reiss, 1991).~      Research has shown the efficacy of CBT in decreasing AS among women with high AS (Watt et~     al., 2006). Unfortunately, access to effective psychological treatments is limited by a~     number of barriers such as a lack of treatment availability or qualified clinicians in an~     area. As such, we are conducting a randomized controlled trial (RCT) of the effectiveness of~     a distance-based CBT program on decreasing AS among those with high AS. A distance delivery~     approach (e.g., via telephone) is one way to minimize treatment barriers and increase access~     to care while still delivering empirically supported treatment. Recent research suggests~     distance delivery is promising (Lovell et al., 2006).~      The RCT will consist of an eight-week structured CBT program based on Watt and Stewart's~     (2008) brief CBT for AS. The program will include weekly modules on psychoeducation,~     cognitive restructuring, interoceptive exposure, and relapse prevention. Participants with~     high AS will be recruited and randomly assigned to the treatment condition or wait-list~     control (after twelve weeks the wait-list group will receive treatment). In the treatment~     condition, participants will be assigned weekly reading and homework from the treatment~     manual. In addition, a therapist will guide them through the treatment by providing~     individualized support and feedback through weekly half-hour telephone sessions. Treatment~     outcomes will be assessed through changes in AS levels and anxiety symptoms pre- to~     post-treatment. Also, participants' satisfaction with the mode of treatment delivery will be~     assessed. We hypothesize that this treatment program will be effective in reducing high AS~     and anxiety symptom frequency and severity. We also expect this project to yield information~     about the utility of distance treatment delivery for mental health care.~   "
181076|NCT01194713|"~     Introduction: Alzheimer's disease (AD) is characterized by neurodegeneration of the brain in~     the form of neurofibrillary tangles and plaques containing the amyloid-beta protein (Abeta).~     Recent animal studies have shown that extended wakefulness is associated with increased~     production of these Abeta proteins and that sleep leads to a marked fall in their production.~      Aim: The investigators aim to distinguish a similar effect of sleep disturbance on~     cerebrospinal fluid (CSF) Abeta levels in humans, which may point out sleep disturbance as an~     important factor in AD development.~      Methods: a study in 26 healthy male volunteers, measuring CSF Abeta levels during a sleep~     deprivation night and before and after a control night with unrestricted sleep.~      Expected results: The investigators expect sleep deprivation to lead to an increase in CSF~     Abeta levels, as compared to the levels in the control night.~   "
181077|NCT01194700|"~     The purpose of this study is to determine the effect of plastic spacers and breath actuated~     spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and~     whether electrostatic charge within plastic spacers has a clinically relevant impact on the~     inhaled steroid delivery.~   "
181078|NCT01194687|"~     Background:~      - Bacteria and other micro-organisms in the intestines play important roles in immunity and~     other health conditions. As a result, these micro-organisms are likely to affect many health~     conditions, including several types of cancer. Because cancer and other diseases may affect~     the digestive system and the bacteria within it, fecal samples that are taken both before and~     after the onset of a disease may show important changes in the body and provide information~     about possible treatments. However, unlike repositories of blood and tissue samples,~     researchers do not have a repository of fecal specimens. Researchers are interested in~     determining whether standard collection procedures used for fecal occult blood testing can~     provide accurate information on micro-organisms in the intestine.~      Objectives:~      - To determine whether standard fecal occult blood testing procedures can provide accurate~     collections of fecal micro-organisms for research purposes.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  At the clinical center, participants will be provided with written and illustrated~          instructions for the collection procedures and a self-administered risk questionnaire.~          The questionnaire will assess the challenges of collecting fecal specimens and will~          collect data on major dietary restrictions (e.g., vegan, vegetarian, food allergies),~          medication use and major illnesses, knowledge of and past experience with fecal occult~          blood testing, colonoscopy and colon cancer, and the fecal collection devices.~        -  Participants will be provided with a collection bag for the sample, 16 sample collection~          tubes, and a box with frozen gel packs.~        -  On the morning of collection, participants will collect the fecal sample in the bag and~          use the collection tubes to obtain material from different parts of the stool.~        -  The tubes will be sealed and placed in the box with the gel packs, and the participant~          will hand deliver the entire box to the clinical center.~        -  Characteristics of the bacteria in the material will be measured by laboratories at the~          University of Maryland.~        -  Statistical comparisons will determine how well the procedures worked.~   "
181080|NCT01194661|"~     Background:~      - Previous research has shown that certain parts of the brain are involved in voluntarily~     stopping an ongoing motor response (movement); however, it is not known whether this same~     network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can~     significantly impair the brain's ability to voluntarily stop or inhibit certain actions.~     Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation~     (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that~     involve moving and suppressing movements, researchers hope to better understand how these~     brain areas might be affected in people who have had TBI.~      Objectives:~        -  To determine the parts of the brain involved in suppressing an urge to act.~        -  To determine the extent to which traumatic brain injury affecting certain parts of the~          brain is involved in problems with suppressing an urge to move and stopping movement.~      Eligibility:~      - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy~     volunteers.~      Design:~        -  This research study includes a screening visit and two study visits, each of which will~          last at least 2 hours.~        -  Participants will be screened with a physical examination and medical history. Women who~          can become pregnant will have a urine pregnancy test before being allowed to participate~          in the study.~        -  At the first study visit, participants will complete one of the following experiment~          tests in an MRI scanner.~        -  Experiment 1: Participants will be shown arrows or images on a computer screen, and will~          press a button or not press a button depending on the image shown. Participants will~          practice the experiment tasks before performing them during MRI scans.~        -  Experiment 2: Participants will be shown arrows or images on a computer screen, and will~          press a button or not press a button depending on the image shown. Participants will~          also have TMS while at rest, and will perform the experiment tasks during the MRI scan.~        -  At the second study visit, participants will have an fMRI scan where they will be asked~          to do simple response tasks with a computer outside the MRI scanner.~      Background:~      - Previous research has shown that certain parts of the brain are involved in voluntarily~     stopping an ongoing motor response (movement); however, it is not known whether this same~     network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can~     significantly impair the brain's ability to voluntarily stop or inhibit certain actions.~     Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation~     (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that~     involve moving and suppressing movements, researchers hope to better understand how these~     brain areas might be affected in people who have had TBI.~      Objectives:~        -  To determine the parts of the brain involved in suppressing an urge to act.~        -  To determine the extent to which traumatic brain injury affecting certain parts of the~          brain is involved in problems with suppressing an urge to move and stopping movement.~      Eligibility:~      - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy~     volunteers.~      Design:~        -  This research study includes a screening visit and two study visits, each of which will~          last at least 2 hours.~        -  Participants will be screened with a physical examination and medical history. Women who~          can become pregnant will have a urine pregnancy test before being allowed to participate~          in the study.~        -  At the first study visit, participants will complete one of the following experiment~          tests in an MRI scanner.~        -  Experiment 1: Participants will be shown arrows or images on a computer screen, and will~          press a button or not press a button depending on the image shown. Participants will~          practice the experiment tasks before performing them during MRI scans.~        -  Experiment 2: Participants will be shown arrows or images on a computer screen, and will~          press a button or not press a button depending on the image shown. Participants will~          also have TMS while at rest, and will perform the experiment tasks during the MRI scan.~        -  At the second study visit, participants will have an fMRI scan where they will be asked~          to do simple response tasks with a computer outside the MRI scanner.~   "
181081|NCT01194648|"~     RATIONALE: Prospective trials using hemi-ablation with high intensity focused ultrasound~     (HIFU) (Sonablate 500) have demonstrated feasibility, safety, and encouraging functional~     outcomes and early cancer control with 90% of men achieving trifecta status (no erectile~     dysfunction, leak-free pad-free continence, cancer control). However, these trials have~     involved small numbers of patients with men selected for good baseline function. A~     multi-centre prospective trial within a larger cohort of men that better represents the~     patient population with prostate cancer (external validity) is required.~   "
181082|NCT01194635|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors understand how patients respond to~     treatment.~      PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue~     samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck~     previously treated with cetuximab, cisplatin, and radiation therapy.~   "
181083|NCT01194622|"~     The primary objective is to assess the effect of azelastine hydrochloride (AZE) on the~     relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed~     AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE~     (i.e. FLU alone in the MP29-02 vehicle; REF).~      The secondary objectives are to compare the relative bioavailability (AUC0-∞) of FLU when~     administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product,~     Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP); To compare the effects of AZE~     on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½); To assess~     adverse events.~   "
181084|NCT01194609|"~     Among the immune cell therapy, autologous adoptive immune cell therapy is a method to~     transfer the immune cells derived from peripheral white blood cells and expanded and~     stimulated with various cytokines and tumor specific antigens in cancer patients. Recently,~     the low-dose radiation is known to increase the immune response in many human cancer~     patients. In a clinical trial, 70% response rate with combination of low-dose radiation and~     adoptive immune cell therapy was reported in recurrent melanoma patients. This study is to~     investigate the feasibility of combination of low-dose radiation and autologous immune cell~     therapy in recurrent cervical cancer which is resistant to conventional palliative treatment.~   "
181085|NCT01194596|"~     The purpose of this study is to evaluate the effectiveness of the spirometric results~     information advice about the smoking habit the investigators designed an intervention trial~     in primary care.~      Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the~     spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction~     and abandonment than just smoking cessation advice.~      Expected results: In adult smokers, a detailed discussion of the results yielded by~     spirometry tests together with brief smoking cessation advice on the part of the primary care~     practitioner can facilitate tobacco reduction and abandonment.~   "
181086|NCT01194583|"~     The study's major aim is to investigate the ability of a commercial Electronic Nicotine~     Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers~     unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and~     cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe. The~     study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and~     adverse events of a currently marketed device in Italy (Categoria electronic cigarette -~     NO nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device~     that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal~     symptoms and cravings independently from nicotine delivery.~   "
181087|NCT01194570|"~     This randomized, parallel group, double-blind, placebo controlled study will evaluate the~     efficacy and safety of ocrelizumab in participants with primary progressive multiple~     sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or~     placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label~     Extension (OLE) treatment for participants in both groups who in the opinion of the~     investigator could benefit from further or newly initiated ocrelizumab treatment. Unless~     terminated early, all participants will continue their treatment with open-label ocrelizumab~     until the last participant who entered the OLE phase reaches 4 years of open-label~     ocrelizumab treatment.~   "
181119|NCT01194154|"~     This randomized, single-blind, proof-of-concept study will investigate the protective effects~     of early treatment with Mircera in participants with chronic kidney disease on renal disease~     progression. Participants will be randomly assigned to receive 30 microgram (mcg) Mircera as~     subcutaneous injection once monthly or matching placebo. Depending on change of hemoglobin~     values, the dose of Mircera can be adjusted to 50 mcg or 75 mcg once monthly. The anticipated~     time on study treatment is 24 months.~   "
181135|NCT01193946|"~     The purpose of this study is to evaluate dietary protein requirements in elderly women aged~     80 years and older using the indicator amino acid oxidation technique.~      Hypothesis to be tested: Protein requirement for elderly women is higher than the estimated~     average requirement of 0.66 g∙kg-1∙d-1 protein. The recommended protein intake for elderly~     women is higher than the recommended dietary allowance of 0.80 g∙kg-1∙d-1 protein.~   "
181088|NCT01194557|"~     Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor~     access to health facilities, home management of malaria (HMM) can improve the timeliness of~     treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and~     impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as~     well as in formal health facilities. Up to 80% of malaria cases are treated outside the~     formal health sector and shops are frequently visited as the first (and in some cases only)~     source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role~     of shops in home management and to ensure that drugs sold are appropriate. The current~     practice of presumptive treatment of any febrile illness as malaria (both at health~     facilities and in the context of HMM) based solely on clinical symptoms without routine~     laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT~     being a more costly regimen, it is important to be more restrictive in its administration and~     rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in~     remote locations lacking electricity and qualified health staff.~      This study therefore proposes to evaluate the feasibility, acceptability, and~     cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug~     shops in an area with high malaria transmission.~   "
181089|NCT01194544|"~     Gastroesophageal reflux disease (GERD) is commonly seen in Western countries; however, it is~     gaining prevalence in Asia countries recently. In addition to the lower esophageal sphincter~     and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is~     also responsible for maintaining an antireflux barrier. Hill et al developed a grading system~     of gastroesophageal flap valve (GEFV) and concluded that this flap valve system is simple,~     reproducible, and offers diagnostic aid in the evaluation of patients with suspicious reflux~     disease undergoing esophagogastroduodenoscopy (EGD). It is a common belief that large meals~     provoke considerable postprandial reflux and it results from an increase in the rate of~     transient lower esophageal sphincter relaxations. One study also revealed that rapid food~     intake produces more gastroesophageal reflux in healthy volunteers. So this study attempted~     to evaluate the relationship between dietary habit and GEFV abnormality. The investigators~     used a questionnaire regarding the dietary habit to the population undergoing EGD in a~     self-paid health examination.~   "
181090|NCT01194531|"~     Natera is recruiting patients for a research study evaluating pregnancy and implantation~     rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening~     (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy.~      Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited~     to participate in a randomized study.~      The purpose of this study is to determine whether PGS- testing of embryos created during IVF~     for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and~     implantation rates in patients when compared to patients whose embryos are not tested. PGS~     will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera.~      All subjects who qualify and enroll will receive discounted IVF medications (both TEST and~     CONTROL arms). If you become pregnant during the study, you will receive a small payment for~     providing information about your pregnancy and birth. If you are assigned to the TEST arm of~     the study you will receive free PGS.~   "
181091|NCT01194518|"~     The lifestyle consulting program through one year follow-up could effective increase the~     scores of health responsibility and nutrition according to the past three-year study.~     Behavior change is a dynamic and complex process. Using a long-term follow up approach will~     be able to understand the trajectory of behavior change. The purpose of this study is to~     explore life experience and lifestyle intervention program for patients with chronic kidney~     disease using mixed methods with a longitudinal approach. The first year of this study will~     include a qualitative study with in depth interview of the subjects who attend previous study~     in the research team and have the scores of health promoting lifestyle among the highest 27%~     and lowest 27%. The life experience will be explored. The quantitative study will be an~     experimental design. Qualified subjects will be randomly assigned to intervention or control~     group. The intervention protocol is based on trans-theoretical model. Each subject will be~     followed every six months. The second and third year of studies will continue to use the~     qualitative and quantitative approach to understand the life experience and meaning among~     patients with chronic kidney diseases. The trajectory of life experience and life style~     changes will be explored. The method may strengthen the effectiveness of lifestyle program~     and may provide comprehensive understanding of the trajectory of behavior changes among~     patient with chronic kidney disease.~   "
181092|NCT01194505|"~     Anterior Cruciate Ligament ACL reconstruction can be performed under the combination of~     posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same~     outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks.~     More specifically under the combination of sciatic nerve block plus femoral nerve block plus~     obturator nerve block.~   "
181093|NCT01194492|"~     The purpose of this study is to determine whether the kinetics of endogenous albumin is~     altered by the generalized inflammation caused by major abdominal surgery.~   "
181094|NCT01194479|"~     Insulin treatment often causes the blood glucose levels to fall too low. The body usually~     responds to low blood glucose levels by releasing hormones which act against the insulin to~     help correct the low blood glucose levels. However, this hormone response can be altered in~     people with diabetes. Currently there are no therapeutic agents that can be used to improve~     the recovery from hypoglycemia (low blood sugar). The aim of this study is to determine~     whether a formoterol inhaler can be used to improve and accelerate the recovery from~     hypoglycemia in patients with type 1 diabetes.~   "
181120|NCT01194141|"~     Barth syndrome (BTHS) is a genetic disease that results in heart failure, muscle weakness and~     exercise intolerance. Several studies in non-BTHS heart failure suggest that endurance~     exercise training is beneficial in improving exercise intolerance, heart function and quality~     of life in young men with BTHS. This study will examine the effects of Endurance (i.e.~     aerobic) exercise training on exercise tolerance, heart function, and quality of life in~     adolescents and young adults with BTHS. We hypothesize that 3 months of endurance training~     will improve exercise tolerance, heart function and quality of life in adolescents and young~     men with BTHS.~   "
181167|NCT01193530|"~     The goal of this research study is to learn if a type of light therapy can be used to help~     patients with advanced cancer who are having difficulty sleeping to sleep better.~   "
181095|NCT01194466|"~     The overall goal of this study is to examine the effect of a single dose of TENS on mucositis~     pain and function secondary to head and neck radiation therapies. Oral mucositis is an~     extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth,~     nose, and throat) that causes significant pain, functional impairment, and diminished quality~     of life. Head and neck cancers pose specific challenges to effective pain management and past~     studies suggest the use of effective non-pharmacologic strategies such as TENS may be~     particularly beneficial for avoiding sources of acute and chronic pain, thereby improving~     quality of life. The investigators hypothesize that a single dose of TENS will decrease pain~     and improve function and quality of life in head and neck cancer patients. This project is~     particularly innovative because it is the first known study to examine the efficacy of TENS,~     an established safe, inexpensive and easy-to-use non-pharmacologic pain management~     intervention, for treating acute oral mucositis pain. The investigators research translates~     bench (animal model) science to human subjects using an interdisciplinary approach to pain~     management. Establishing whether TENS is effective for reducing mucositis pain is a critical~     first step toward establishing an effective, non-pharmacologic pain relief intervention for~     mucositis.~   "
181096|NCT01194453|"~     A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC)~     cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient~     administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences~     based on histologic type. The investigators want to research some biomarkers that can predict~     clinical outcomes.~   "
181097|NCT01194440|"~     RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal~     symptoms in women receiving hormone therapy for breast cancer.~      PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing~     musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast~     cancer receiving letrozole.~   "
181098|NCT01194427|"~     This research study is designed to look at the effects of the combination of vorinostat~     (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The~     investigators will do this by comparing tissues from the original breast biopsy to tissues~     obtained after taking vorinostat and tamoxifen for 2 weeks.~   "
181099|NCT01194414|"~     This randomized, double-blind, parallel group study compares the efficacy and safety of~     subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with~     moderate to severe active rheumatoid arthritis. Participants were randomized to receive~     either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv~     every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24.~     The double-blind period was followed by a 72-week open-label treatment with some switching of~     sc and iv administration. No placebo was administered in the open-label phase. Participants~     continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout~     the study. Anticipated time on study treatment was 2 years.~   "
181100|NCT01194401|"~     This prospective, multi-center observational study will assess the long-term efficacy and~     safety of RoActemra/Actemra in daily practice in patients with active moderate to severe~     rheumatoid arthritis who have an inadequate response or are intolerant to one or more~     disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.~     Data will be collected from patients initiated on RoActemra/Actemra treatment according to~     label by decision of the treating physician. Anticipated time for data collection from each~     patient will be 2 years.~   "
181101|NCT01194388|"~     The current observational evaluation is designed to evaluate the performance of the Axium™~     MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life~     practice.~   "
181102|NCT01194375|"~     The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in~     treating patients with acne vulgaris.~   "
181103|NCT01194362|"~     For this study, blood and tissue samples will be collected in order to perform genetic~     testing to help researchers gather information about this disease and how and why it affects~     some patients more than others.~   "
181104|NCT01194349|"~     Thrombocytosis, mostly reactive in nature, is common in pediatric hospitalized patients with~     infections. Streptococcus pneumoniae (S. Pneumoniae) is the most common pathogen. In this~     study, the investigators investigated the associations of clinical profiles and~     thrombocytosis and evaluated platelet counts, leukocyte counts and CRP levels as predictors~     of hospitalization days in patients with S. pneumoniae infection.~   "
181105|NCT01194336|"~     The primary objective of this study is to determine whether huperzine A, donepezil, and~     galantamine impact militarily relevant aspects of neurocognitive performance in humans,~     compared to placebo.~   "
181106|NCT01194323|"~     GERD is a common condition in the western world. In most cases, the diagnostic is established~     by good response to empiric proton pump inhibitor (PPI) therapy. When the patient symptoms~     are refractory to therapy, multiple invasive tests are available. The results of those tests~     (EGD, manometry, Ph monitoring and impedance) are clues that the physician use together to~     establish the diagnostic. No test however can be use alone because of their poor specificity~     and sensitivity. Recently, microscopy has been used to detect dilated intercellular space in~     between distal esophageal cells tissue; unfortunately this marker again failed to diagnose~     GERD.~      In search of more sensitive and specific markers of GERD, we propose to assess if acid~     exposure affects: 1) gene and proteins expression in the esophageal/post-cricoid area tissue;~     and 2) local impedance of the mucosa. The secondary aim of this proposal is to determine if~     correlation exists between the two approaches.~   "
181107|NCT01194310|"~     This study compares efficacy (i.e. IOP and hypotensive medications) of phaco alone vs.~     combined phaco plus excimer laser trabeculotomy vs. combined phaco plus trabectome.~   "
181121|NCT01194128|"~     This study will assess the effects of an intervention targeting family caregivers who~     recently placed a relative in a long-term care facility because of cognitive and/or physical~     disability. In a two group randomized clinical trial we predict that caregivers assigned to~     active treatment will have lower levels of depressive symptoms, anxiety symptoms, and greater~     satisfaction with the long-term care facility when compared to individuals assigned to the~     control condition.~   "
186703|NCT01120782|"~     The purpose of this study is to determine whether the prescription determined for a new daily~     disposable toric contact lens will be a good match to a prescription determined for an~     existing brand of lens.~   "
181108|NCT01194297|"~     Severe influenza respiratory disease is increasingly recognized in children. Influenza~     hospitalization rates in high-risk infants, such as premature infants, are increased some~     five-fold over rates in other children. The recently-licensed live attenuated influenza~     vaccine (LAIV) promotes better immune responses than the trivalent inactivated vaccine, but~     can cause wheezing. The balance of risks and benefits for LAIV in extremely premature~     infants, who may be at increased risk for both influenza disease and vaccine side effects, is~     unknown.~      The specific aim of this project is to compare the immune response and reactions of~     trivalent, inactivated influenza vaccine (TIV) and live, attenuated, intranasal influenza~     vaccine (LAIV) in groups of former premature (PT), very (V) LBW and former full-term (FT)~     infants aged 24-35 months.~      The investigators hypothesize that the immune response in FT infants will be greater with~     LAIV than TIV, and that wheezing episodes will be no more than twice as frequent in LAIV as~     in TIV recipients.~      The study will enroll 14 former premature, VLBW infants and 14 former full-term infants.~     Children will be randomized to receive one dose either TIV or LAIV. Vaccine reactions will be~     measured. One to two teaspoons mL of blood will be drawn at 0 and 7-14 days from~     immunization, and less than one teaspoon of blood will be drawn at 28-42 days.~   "
181109|NCT01194284|"~     This study is an observational safety surveillance study designed to prospectively assess~     patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide~     within the context of prevailing standard oncology practice~   "
181110|NCT01194271|"~     The goal of this clinical research study is to learn how ipilimumab in combination with~     Lupron (leuprolide acetate) affects the body's own defense (immune) system before having~     surgery to remove prostate cancer. The safety of the drug combination will also be studied.~   "
181111|NCT01194258|"~     The purpose of the study was to compare Humalog (insulin lispro)-recombinant human~     hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the~     treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.~   "
181112|NCT01194245|"~     The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human~     hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for~     the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.~   "
181113|NCT01194232|"~     Cystic Fibrosis (CF), the most common inherited disease in Caucasians, is characterized by~     chronic pulmonary inflammation and progressive loss of gas exchange units that eventually~     results in respiratory failure. There is strong evidence that, in CF, abnormally low~     perfusion carries a high risk of death independent from the presence of pulmonary~     hypertension. However, the evolution of pulmonary vascular disease in CF and how it might~     contribute to the rate of decline in lung function is not known. Our knowledge remains~     limited to the results of old observational studies which concluded that the major causes of~     pulmonary vascular remodeling and hypertension in CF are hypoxic respiratory failure and~     destruction of lung tissue. Our recent data obtained by state-of-the-art Magnetic Resonance~     Imaging (MRI) of the pulmonary circulation, challenges the existing paradigm. We demonstrate~     that in the absence of hypoxia, significant changes in pulmonary perfusion and in surrogate~     measures of vascular resistance as well as in collateral blood flow begin early in the course~     of CF. Newly developed therapeutics have altered dramatically the course of patients~     suffering from pulmonary vascular disease. Through this 8 week trial, we will examine by~     Magnetic Resonance Imaging the effect of Sildenafil on pulmonary perfusion and systemic~     vascularization of the lungs in subjects with mild to moderate disease.~   "
181114|NCT01194219|"~     This study evaluated the effects of an called apremilast. Apremilast works by lowering some~     of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The~     purpose of this study was to test apremilast and compare its effects to placebo (an inactive~     substance which contains no medicine but is in the same form as the drug). This study was~     able to test for efficacy (improvement of signs and symptoms) and safety of apremilast in~     patients with moderate to severe psoriasis.~   "
181115|NCT01194206|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Stereotactic body~     radiation therapy may be able to send x-rays directly to the tumor and cause less damage to~     normal tissue in patients with liver cancer. Giving stereotactic body radiation therapy may~     also increase patient eligibility for liver transplant.PURPOSE: This phase II trial is~     studying how well stereotactic body radiation therapy works in treating patients with liver~     cancer that cannot be removed by surgery or transplant.~   "
181116|NCT01194193|"~     To investigate the safety and tolerability of AZD8055 intermittent dosing schedules when~     given orally to patients with advanced solid malignancies and lymphomas. Two intermittent~     dosing schedules will be explored with increasing doses until a maximum tolerated dose is~     determined for each schedule.~   "
181117|NCT01194180|"~     The purpose of this study is to evaluate the BCG 'challenge' model a four-arm study design~     has been chosen. Twelve subjects will be recruited into each arm of the study. Allocation of~     BCG-naïve volunteers to either group A or B, and BCG-vaccinated volunteers to either group C~     or D, will be performed on a one-to-one alternating basis. Subjects in each group will be~     challenged by BCG administered intradermally. Prior to challenge, pre-existing immunity to TB~     will be induced by vaccination with BCG, MVA85A, and both in combination (when compared to~     BCG- & MVA85A-naïve individuals). BCG quantification will be assessed by analysing the tissue~     obtained in a punch biopsy of volunteers' skin over the site of BCG 'challenge' vaccination.~     Any reduction in BCG quantification between groups will then be correlated to existing (and~     future) laboratory assays of vaccine-induced immune responses in order to identify potential~     immunological correlates of protection.~   "
181118|NCT01194167|"~     This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia~     (low platelet count). Eltrombopag is approved by the FDA for the treatment of~     thrombocytopenia (low platelet count) in adults who have had an insufficient response to~     medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the~     FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to~     platelet transfusion and so for this study is considered investigational.~   "
181180|NCT01193361|"~     At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and~     efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the~     treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1~     subjects~   "
181122|NCT01194115|"~     The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour~     course of broad spectrum antibiotics prevents wound infection complications in patients that~     are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women~     undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a~     prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of~     normal vaginal flora will decrease the rate of surgical site infection in obese patients that~     are at a greatly increased risk of postoperative infections complications.~   "
181123|NCT01194102|"~     The purpose of this study is to evaluate whether persons with stroke participating in a~     12-week community based wellness program for persons who have had a stroke, experience~     improved mobility (6 Minute Walk Test), balance, (The Short Portable Performance Test and~     Timed Up and Go), strength (JAMAR hand grip dynamometry), level of physical activity (Rapid~     Assessment of Physical Activity), reintegration in community (Reintegration into Normal~     Living Index), self efficacy (Patient Activation Measure) and Quality of Life (Stroke~     Specific Quality of Life Scale) compared to persons who do not participate in the program.~   "
181124|NCT01194089|"~     This prospective, randomized, double-blind study will enroll nonsmoking female subjects~     undergoing laparoscopic bariatric surgery under general anesthesia. The hypothesis of this~     study is that female nonsmokers who receive nicotine via nasal spray immediately before~     waking up from anesthesia will need less pain medications 24 hours after the surgery compared~     to the subjects who receive placebo spray.~   "
181125|NCT01194076|"~     The purpose of this study is to examine how well intensive cognitive-behavioral therapy (CBT)~     delivered over 5 days works in reducing Obsessive-Compulsive Disorder (OCD) symptoms in~     children and adolescents. Treatment will consist of exposure and response prevention with an~     added focus on teaching parents to be exposure coaches.~   "
181126|NCT01194063|"~     Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.~   "
181127|NCT01194050|"~     This observational study will investigate the tolerability and efficacy of Tarceva~     (erlotinib) in daily clinical practice under routine conditions in patients with locally~     advanced or metastatic non small cell lung cancer. Data will be collected for approximately~     12 months.~   "
181128|NCT01194037|"~     The primary objective of this study is to evaluate the safety and tolerability of ascending~     doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study~     is to define the PK and PD of ascending doses of Hanferon™ in combination with RBV. The~     exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy~     in combination with RBV.~   "
181129|NCT01194024|"~     The goal of this multicenter study is to develop a standardized scoring system for inhalation~     injury that can be used both to quantify and predict injury severity inhalation injury in~     adults over 18 years of age. A model will be developed based on clinical, radiographic,~     bronchoscopic, and biochemical parameters that will predict the severity of inhalation injury~     with greater than 80% predictive accuracy~   "
181130|NCT01194011|"~     Research objectives To provide people with sufficient information regarding health care and~     to improve its quality, this research endeavors to discuss the establishment of a health care~     information openness and transparency mechanism within the framework of the National Health~     Insurance system. This research also evaluates whether the transparency of health care~     quality information makes care givers provide better quality. Meanwhile, when appropriate~     information and quality index are presented to patients, patients shall have more knowledge~     about what they are dealing with, hence less misunderstanding between hospitals and patients~     would occur.~      Research Methods~        1. To revise indicators based on international trends, related literature and the need of~          people.~        2. To present 50 sets of quality indicator statistically on the website, and provide~          updated information about the first 10 sets.~        3. To analyze and explain the outcome and purposes of the indicator to the public.~        4. To estimate the possible trend for the coming year, and provide adaptive strategy.~        5. To promote the website, and hold workshops in all six regions of Taiwan.~        6. To make the website linked to the top 5 most populated official and unofficial websites.~        7. To respond to questions on the forum of the website daily, and maintain the system,~          update the website regularly.~        8. To complete the acceptability survey on health care institutions and people.~   "
181131|NCT01193998|"~     The purpose of this study is to evaluate a validated diagnostic prediction model in the~     appropriate diagnosis of Acute Heart Failure (AHF) in patients presenting at the emergency~     department with undifferentiated dyspnea.~   "
181132|NCT01193985|"~     This an open, uncontrolled multicenter clinical study to assess the safety and performance of~     the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.~      The primary objective is to determine the safety of the WK-6 surgical mesh. Data will be~     compared retrospectively with published studies on inguinal hernia mesh.~      The secondary objectives are to explore the performance of the surgical mesh by measuring the~     pain pre and post surgery as well as a number of relevant variables for establishing the~     performance of the mesh. Data will be compared retrospectively with previous studies on~     inguinal hernia mesh with a follow-up of at least one year.~   "
181133|NCT01193972|"~     A decision aid tool will be developed using participatory research approach. The decision aid~     will be targeted to cigarette smokers scheduled for elective surgery.~   "
181134|NCT01193959|"~     Present study is aimed at investigating potential molecular predictors of sensitivity or~     resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of~     advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be~     investigated with either immunohistochemistry, fluorescence in situ hybridization or~     genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide~     ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide~     formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat~     sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC)~     and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).~   "
181181|NCT01193348|"~     The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients~     with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal~     impairment.~   "
181136|NCT01193933|"~     1. evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the~          efficacy of its substitution by dexamethasone if blast count is 25% and more~        2. feasibility for adults of no interruptions protocol with 8 weeks induction and 14~          weeks consolidation followed by 2-years maintenance.~        3. tolerability and efficacy in adults of the prolonged L-asparaginase application (total~          proposed dose 560.000 IU)~        4. feasibility and efficacy of autologous stem cell transplantation for T-cell ALL~   "
181137|NCT01193920|"~     This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at~     one dose in healthy non pregnant women and then in three different doses in healthy pregnant~     women.~   "
181138|NCT01193907|"~     This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations~     of Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with~     the currently licensed Vi polysaccharide vaccine~   "
181139|NCT01193894|"~     This study aim to investigate the effect of Profermin versus Fresubin in the dietetic~     treatment of active ulcerative colitis.~   "
181140|NCT01193881|"~     This phase I trial studies the side effects and best dose of gamma-secretase/Notch signalling~     pathway inhibitor RO4929097 (RO4929097) and erlotinib hydrochloride when given together in~     treating patients with non-small cell lung cancer that is stage IV or has come back.~     RO4929097 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
181141|NCT01193868|"~     This phase II trial is studying how well RO4929097 works in treating patients with advanced~     non-small cell lung cancer who have recently completed treatment with front-line~     chemotherapy. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
181142|NCT01193855|"~     RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This randomized phase II trial is studying how well giving dutasteride works in~     treating patients with prostate cancer.~   "
181143|NCT01193842|"~     This partially randomized phase I/II trial studies the side effects and the best dose of~     vorinostat when given together with combination chemotherapy and rituximab to see how well it~     works compared to combination chemotherapy alone in treating patients with human~     immunodeficiency virus-related diffuse large B-cell non-Hodgkin lymphoma or other aggressive~     B-cell lymphomas. Vorinostat may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with~     the ability of cancer cells to grow and spread. Giving vorinostat together with combination~     chemotherapy and rituximab may kill more cancer cells.~   "
181144|NCT01193829|"~     1. To compare EGFR mutations between primary non-small cell lung cancer (NSCLC) tumours and~          corresponding CTCs isolated by a label-free microfluidic device-based system~        2. To characterize the association between clinical response in NSCLC patients treated with~          gefitinib and serial changes in CTC EGFR mutations detected by a label-free microfluidic~          device-based system~      The investigators recently developed a label-free, microfluidic device for capturing~     circulating tumour cells (CTCs) and acquired a Fluidigm Biomark digital PCR instrument for~     reliable low-level DNA quantification. The overall aim of this study is to test the~     feasibility of using these state-of-the-art devices to reliably detect clinically relevant~     EGFR mutations in CTCs.~   "
181145|NCT01193816|"~     This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming~     patients down in a situation of restlessness during mechanical ventilation weaning. This drug~     is used for several years to quieten restless patients. Its purpose is to restore spontaneous~     breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation.~   "
181146|NCT01193803|"~     Osteoarticular infections are painful and disabling diseases that require antimicrobial~     treatment adapted to the microorganisms implicated. Microbiological cultures are currently~     regarded as the reference for identification of pathogenic bacteria. However, the sensitivity~     of these cultures is very variable and depends both on the context in which clinical samples~     are taken, and on the pathogen involved. The rate of detection varies according to infection~     type: from 50 to 70% for infectious spondylodiscitis, 65 to 95% for prosthetic joint~     infections, 50% for gonococcal arthritis and 90% for non-gonococcal arthritis. The aim of the~     study is to evaluate the diagnostic performances of microbiological cultures and molecular~     methods in case of osteoarticular infections. The gold standard will be established by an~     expert group of osteoarticular infection (composed by a bacteriologist, a radiologist, a~     surgeon, an anatomy-pathologist and a rheumatologist), which established the final diagnosis~     of infected or not infected patients.~   "
181147|NCT01193790|"~     The investigators wish to evaluate coblation channeling in the treatment of chronic~     tonsillitis.~   "
181148|NCT01193777|"~     Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000~     patients in the United States develop sepsis every year. As sepsis becomes progressively more~     severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen~     to the rest of the body, which is necessary for normal cell function. This is called septic~     shock. When someone develops septic shock, it is very common for the smallest blood vessels~     in the body called the microcirculation to clog, like a highway during rush hour. Even with~     the best medical care, more than one in three patients with septic shock will die.~      The major goal of this study is to test if intravenous replacement of a naturally occurring~     nutrient that is lost by the body during sepsis called L-carnitine can reduce how sick a~     patient with sepsis becomes. In our study, some patients will receive L-carnitine and others~     will receive saline. We will measure markers determining severity of illness in both groups~     and compare them to see if L-carnitine helps patients get better faster. Based on research~     already conducted, we believe L-carnitine will improve blood flow in the microcirculation,~     delivering more oxygen to cells, and help the body get better. To test if this is true, we~     will directly look at the microcirculation under the tongue with a special magnifying camera~     that looks at red blood cells, and compare both groups.~   "
181194|NCT01193153|"~     This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the~     delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the~     safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.~   "
181149|NCT01193764|"~     The investigators conducted a recent pilot study and found a strong positive correlation~     between the consumption of 100% chocolate and acne exacerbation. However, this study had~     limitations including the lack of placebo and the small sample size. Although studies have~     been conducted assessing chocolate's effect on acne, no study has been done evaluating this~     effect using chocolate with 100% cocoa content in a double blind placebo controlled fashion.~     This study will analyze the difference in the number and type of acneiform lesions per~     subject at the different time points (Day 4 and Day 7) compared to baseline in order to~     increase the validity of the investigators results. In addition, the investigators will use~     unsweetened cocoa powder,12 rather than chocolate candy, which contains higher quantities of~     additive ingredients such as sugar and milk to avoid interference with the results and the~     possibility to establish or not an association between the unsweetened cocoa and an effect on~     acne.~   "
181150|NCT01193751|"~     The specified Apgar-Score in combination with the AAP-Score predicts the morbidity and~     mortality of asphyxiated newborns.~   "
181151|NCT01193738|"~     The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep~     obstructive apnea syndrome (OSA).~   "
181152|NCT01193725|"~     This study is evaluating the efficacy of virtual realty exposure therapy (VRET)by comparing~     it to prolonged exposure therapy (PE) and a waitlist (WL) group for the treatment of post~     traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The~     investigators will test the general hypotheses that 10 sessions of VRET or PE will~     successfully treat PTSD, therapeutically affect levels of physiological arousal, and~     significantly reduce perceptions of stigma toward seeking behavioral health services.~   "
181153|NCT01193712|"~     The purpose of this study is to determine whether left ventricular endocardial pacing~     exhibits a greater acute hemodynamic response during biventricular pacing in patients who do~     not show this response to standard cardiac resynchronization therapy.~   "
181154|NCT01193699|"~     The purpose of this study is the identification of the maximum tolerated dose (MTD) of the~     investigational medicinal product. Moreover the safety and tolerability will be assessed and~     an exploratory analysis of efficacy and biomarker modulation will be performed.~   "
181155|NCT01193686|"~     The goal of this study was to train OIF/OIF Veterans with multiple injuries to be Peer~     Visitors, i.e., Volunteers who visit more recently OIF/OEF Veterans and provide support. We~     evaluated the effectiveness of the training, and any benefits that Volunteer Peer Visitors~     and the Recipients of Peer Visitors experienced as a result of participating in Peer~     Visitation.~   "
181156|NCT01193673|"~     The primary objective of the study is to find the gene(s) responsible for causing DDH. The~     secondary objective of the study is to determine the mode of genetic transmission of DDH.~   "
181157|NCT01193660|"~     This randomized control study is aimed to determine efficacy of umbilical cord blood and~     erythropoietin combination therapy for children with cerebral palsy.~   "
181158|NCT01193647|"~     This study will begin to evaluate the heritability of rotator cuff disease, and begin~     creation of a powerful resource for future genetic studies of rotator cuff disease.~   "
181159|NCT01193634|"~     The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features:~      The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding~     potential lost of capture.~      Then, the ICD devices have also the capability to be remotely interrogated through the remote~     monitoring system whose performances will be reported during the study.~      Finally the study will report the electrical and handling performances of the new left~     ventricular lead.~   "
181160|NCT01193621|"~     In the present study, the investigators will establish the clinical trial technology for~     early evaluation of drug characteristics in terms of pharmacokinetics and pharmacodynamics~     for haloperidol as a model drug, using positron emission tomography.~   "
181161|NCT01193608|"~     This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients~     with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812)~     or placebo. Each patient's participation will last approximately 41 weeks.~   "
181162|NCT01193595|"~     Primary Objective:~      - To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of~     ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of~     related Dose Limiting Toxicities (DLTs).~      Secondary Objectives:~        -  To assess the overall safety profile of the combination~        -  To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab when~          given in combination~        -  To evaluate preliminary evidence of anti-tumor activity~        -  To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound)~          DCE-US, measuring biomarkers~   "
181163|NCT01193582|"~     A vaccine called Prevenar is already approved for use in China for vaccination of children~     younger than 6 years old against infections caused by Streptococcus pneumoniae.~      This study is to measure the amount of antibodies (antibodies help people fight off diseases)~     Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar.~     The study will also provide more data on how safe and well tolerated Prevenar is in Chinese~     children.~   "
181164|NCT01193569|"~     The objective of this study is to determine the natural history of acute ischemic stroke from~     large vessel thromboembolism in the brain. The target population is a stroke cohort with a~     known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke Scale~     (NIHSS) score >10 who are eligible for mechanical thrombectomy but without receiving the~     treatment. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled~     patients will be followed for 90 days after the index event.~   "
181165|NCT01193556|"~     The objective of this clinical study is to evaluate the operative performance of the PEAK~     PlasmaBlade® TnA during subcapsular tonsillectomy; to monitor and record post-operative~     clinical outcome variables; and to compare these endpoints to the Standard of Care (SOC).~   "
181166|NCT01193543|"~     Preliminary studies in rats and mice indicate that calanus oil reduce accumulation of~     intra-abdominal fat. Pilot studies in humans have shown no adverse effects. In the present~     study 120 subjects, males and females, 20-65 years old, BMI 25-30 kg/m2 will be included and~     given calanus oli 1 g twice daily versus placebo for 1 year. The hypothesis is that calanus~     oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.~   "
181168|NCT01193517|"~     The goal of the Phase I portion of this study is to find the highest tolerable dose of~     azacitidine combined with capecitabine and oxaliplatin (CAPOX) that can be given to patients~     with metastatic colorectal cancer.~      The goal of the Phase II portion of this study is to learn if azacitidine, given in~     combination with CAPOX, can help to control metastatic colorectal cancer. The safety of this~     drug combination will also be studied.~   "
181169|NCT01193504|"~     The purpose of this study is to determine if Lotemax eye drops are at least as effective as~     Pred Forte eye drops, which are the standard of care after cataract surgery.~   "
181170|NCT01193491|"~     The purpose of this study is to evaluate the safety, determine the maximum tolerated dose~     (MTD) and schedule of IPI-493 in patients with hematologic malignancies.~   "
181171|NCT01193478|"~     The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics~     and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype~     1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the~     clinic for the initial 5 days of the study.~   "
181172|NCT01193465|"~     The effects of preserving humidity and temperature by low flow anesthesia are different in~     each other anesthesia workstation.~   "
181173|NCT01193452|"~     This phase II trial on the assumption that S-1 combined with Leucovorin may have better~     efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with~     advanced colorectal cancer.~   "
181174|NCT01193439|"~     Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes.~     Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural~     neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The~     indication of thoracoscopy in patients with pleural effusion has been optimized. In some~     studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate~     of complications. However the investigators do not know its safety on high risk patients.~     Because many patients having suspected malignancy have bed conditions due to other health~     problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the~     investigators aimed to test the safety of medical thoracoscopy in the patients with high risk~     for complications.~   "
181175|NCT01193426|"~     Spontaneous bacterial peritonitis (SBP), an infection of ascitic fluid in the absence of~     localized intra-abdominal infection, is one of the main potentially fatal complications of~     cirrhosis. In the case of SBP, early diagnosis and rapid therapeutic care can improve patient~     survival (Garcia-Tsao, 2001).~      The diagnosis of SBP is based on the detection of a polymorphonuclear neutrophils count equal~     to or greater than 250 /mm3 in the ascitic fluid (method of reference). However, obtaining an~     ascitic cell count is sometimes difficult because it can not always be performed in emergency~     especially outside the opening hours of the laboratory of Bacteriology. This raises the~     necessity of developing quick and easy alternative approaches of diagnosis.~      Few groups have proposed the use of urinary reagent strip for rapid diagnosis of SBP.~     Nevertheless, the investigators clinical teams have shown that the sensitivity of this test~     was low in a large national multicenter prospective study involving more than a thousand~     patients (Nousbaum et al., 2007). The use of Multistix strips test is thus not recommended~     for the routine application of diagnosis of SBP due to its lack of sensitivity.~      Although performed on small groups of patients, several studies have reported that IL-8 or~     IL-6 might be used as markers of ascitic fluid infections. Based on these data and confirmed~     by the investigators preliminary results the investigators propose to study on a broad~     recruitment of patients estimated to about 500 inclusions (about 45 infected patients) the~     interest of using IL-8 and IL-6 as predictive markers of SBP. The investigators propose to~     use an ELISA method, standardized, rapid and automated, applicable in the context of~     emergency (7 days a week and 24 hours a day) as previously described in the work conducted to~     exclude the urinary tract infection (Oregioni et al., 2005).~      During the preliminary experiments conducted for this project, the investigators also found~     systematic variation of another marker, leptin. This is a protein hormone involved in the~     inflammatory and immune responses (Otero et al., 2005). It appears necessary to include the~     study of this marker in the analysis of differential protein response between patients~     suffering or not suffering from SBP.~      The investigators therefore propose a diagnostic study, non-interventional, prospective,~     multicenter trial conducted over 2 years.~        -  The main objective is to establish the diagnostic performance (sensitivity, specificity,~          positive predictive value and negative) of IL-8 and IL-6, assayed in the ascites fluid~          by an automated ELISA in the early diagnosis of SBP.~        -  The secondary objectives are to confirm the interest of the measurement of leptin in the~          SBP and to establish the diagnostic performance of IL-8 and IL-6 or leptin according to~          different clinical features in patients (score Child-Pugh classification and history of~          SBP, ascitic fluid infection with positive bacterial culture).~   "
181176|NCT01193413|"~     Early diagnosis of secondary infection of necrotic tissue in severe acute pancreatitis is~     extremely important. The investigators evaluated whether the level of soluble TREM-1~     (sTREM-1) in fine needle aspiration (FNA) fluid from patients who suspected infection is a~     good marker of secondary infection of necrotic tissue and an indicator of the proper~     treatment between drainage and necrosectomy.~   "
181177|NCT01193400|"~     Primary outcome measure:~      Evaluate the efficacy in terms of complete responses of induction therapy and first-line~     consolidation of Clofarabine and low-dose Cytarabine with AML patients aged 60 years or more.~     The first efficacy objective is evaluate the overall remission rate (TRG), where general~     reference (RG) is defined as a patient who achieved complete remission (CR) or complete~     remission with inadequate platelet recovery (CPR).~      Secondary outcome measures:~        -  To evaluate disease-free survival (DFS)~        -  Evaluate the overall survival (OS)~        -  To evaluate the safety and tolerability of clofarabine and duration, severity and~          relationship of adverse events (AEs) occurring during treatment~        -  To assess the rate of mortality at 30 days (ie, the incidence of deaths occurring~          between Day 1 and Day 30 of induction cycle)~        -  The incidence, intensity (according to the latest version of the CTCAE classification),~          duration, causality, severity and type of AA~   "
181178|NCT01193387|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate if two~     identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug~     exposure to the body.~   "
181179|NCT01193374|"~     A primary care approach to obesity prevention will be developed and tested in a randomized~     trial in 4 pediatric primary care practices. Enhanced screening for obesity risks and prompts~     for effective counseling at well visits of 4 to 10 year olds will be developed utilizing hand~     held technology( PDAs). The impact on the content and quality of clinician counseling will be~     assessed in exit survey prior to and after implementation. Among families interested in~     making a change to address nutrition or activity risk reported on the screener a cohort with~     children > BMI 85% will be recruited. They will be randomized to mailed tailored supports to~     level of readiness to change versus a single generic informational mailing. The hypotheses~     are that 1)families that receive the enhanced office visit with screening will be more likely~     to plan to make changes compared to usual care; and 2) families receiving the tailored post~     visit supports will be less likely to gain weight than controls after 6 months.~   "
181195|NCT01193140|"~     To evaluate the safety and tolerability of the veliparib/TMZ combination in subjects with~     solid tumors.~   "
181182|NCT01193335|"~     The purpose of this study is to describe the safety, tolerability, and immunogenicity of a~     2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to~     preterm infants with concomitant vaccines, compared to infants born at term.There will be a~     follow-up phase to assess the persistence of the antibody response at 24 and 36 months of~     age.~   "
181183|NCT01193296|"~     The study will assess glycemic variability and optimized glycemic control in T2DM patients~     treated with a DPP-4 inhibitor as add-on therapy to metformin.~   "
181184|NCT01193283|"~     Background:~        -  Severe aplastic anemia (SAA) can lead to problems with bone marrow health and result in~          low blood cell counts, which require frequent transfusions. Standard treatment for SAA~          involves injections of antithymocyte globulin (ATG) plus cyclosporine (CsA). This~          regimen has been shown to improve the blood counts in about two-thirds of patients.~          However, the ATG/CsA regimen has the following limitations: (a) the disease can come~          back (relapse) in about one-third of patients who improve initially; and (b) in about~          10% to 15% of cases, certain types of bone marrow cancer (such as myelodysplasia and~          leukemia) can develop (called evolution). Experience with other drugs in SAA such as~          cyclophosphamide suggests that similar response rates to ATG/CsA can be achieved with a~          lower risk of relapse and clonal evolution. However, cyclophosphamide was found to have~          significant side effects in SAA when investigated over 10 years ago due to increase risk~          of fungal infections.~        -  Better antibiotic drugs against fungus have been developed and are widely used to treat~          patients who have low white blood cell counts and are at risk of developing infections.~          In SAA patients in particular, these newer antibiotics have had a large impact in~          preventing and treating fungus infections. Researchers are revisiting the use of~          cyclophosphamide in SAA treatment, and plan to give a lower dose of CsA in combination~          with the immune-suppressing drug cyclophosphamide, as well as antibiotics to protect~          against infections, as a possible treatment for the disease.~      Objectives:~      - To determine the safety and effectiveness of the combination of cyclophosphamide and~     cyclosporine in treating severe aplastic anemia that has not been treated with~     immunosuppressive therapy.~   "
181185|NCT01193270|"~     The purpose of this pilot trial is to test the safety and efficacy of administering one dose~     of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks~     gestation and less than 1000 grams birth weight). This pilot will examine whether a single~     dose of vitamin E will be absorbed into the infants' bloodstreams with resulting serum~     α-tocopherol level in the target range of 1-3 mg/dl.~   "
181186|NCT01193257|"~     This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus~     prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant~     prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy~   "
181187|NCT01193244|"~     This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700)~     plus prednisone compared with placebo plus prednisone in the treatment of men with~     progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)~   "
181188|NCT01193231|"~     STUDY OBJECTIVE: To evaluate the safety and efficacy of Acuvail 0.45% administered BID for~     increasing corneal re-epithelialization, decreasing the time to zero pain in~     post-photorefractive keratectomy (PRK) surgery, and PRK enhancement assessment at 6 months~     post op~      CLINICAL HYPOTHESES: Acuvail 0.45% administered twice daily is superior to Systane Ultra~     lubricant in treating post PRK pain~      OVERAL STUDY DESIGN:~      Structure: Single-center, randomized, open label, contralateral (one eye receives Acuvail,~     one eye Systane Ultra)~      Treatment Group: Patients will be randomized to the eye that will receive Acuvail 0.45%~     Assignment: Acuvail 0.45% in one eye, Systane Ultra in contralateral eye~      Duration: 6.5 months~      Controls: Systane Ultra preservative-free lubricant~      Dosage/Dose Regimen: Study medication will be administered to the randomized eye through post~     op days 1-2 BID~      Visit Schedule: Screening (baseline), Day 2-30 (Surgery), post surgery Day 1 and each day~     through corneal re-epithelialization, post surgery months 1, 3, and 6.~      Number of Patients: 10 (20 eyes)~      Condition/Disease: patients undergoing bilateral PRK surgery~   "
181189|NCT01193218|"~     This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in~     Japanese patients with T2DM at first treatment period. The second treatment period is~     required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese~     patients with T2DM according to the ICH E1 guideline.~   "
181190|NCT01193205|"~     The aim of this study is to evaluate the effectiveness of a 20-week Dialectical Behaviour~     Therapy (DBT) skills training group for the treatment of chronic suicidal and non-suicidal~     self-injurious (NSSI) behaviours in individuals diagnosed with borderline personality~     disorder (BPD). Previous research has established the effectiveness of a one year~     comprehensive, combined individual and group DBT treatment. However, in practice, DBT is~     often offered in a skills only group format. This study will consist of a randomized,~     controlled trial designed to evaluate the effectiveness of DBT compared to a wait list~     control. 84 participants will be randomized to the 20-week DBT group or the wait-list and the~     following outcomes will be assessed:~        1. frequency of suicidal and NSSI behaviours~        2. symptom distress~        3. impulsivity~        4. treatment retention~        5. skill acquisition and~        6. social functioning~      Assessments will occur at pre-treatment, 10 weeks, 20 weeks and 3 months post treatment. The~     following main hypotheses will be examined: (1) Patients in the DBT skills group condition~     will have superior outcomes to patients on the treatment as usual wait list control in areas~     targeted by the treatment: frequency of suicidal and NSSI behaviours, emergency room visits,~     psychiatric hospital admissions, impulsivity, and knowledge and use of behavioral skills,~     general symptoms. The group receiving DBT will have superior outcomes at post treatment and~     these outcomes will be maintained during the three month post-treatment follow-up.~   "
181191|NCT01193192|"~     This study is a multi-site, retrospective chart review to determine the effect of Neevo® or~     NeevoDHA® (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb)~     levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription medical~     food indicated for the dietary management of women under a doctor's care who face high risk~     pregnancies, older overactive bladder (OB) patients and patients unable to fully metabolize~     folic acid. Data will be collected from existing patient charts of subjects administered~     Neevo® or NeevoDHA® daily compared to subjects administered a prenatal vitamin daily.~   "
181192|NCT01193179|"~     The purpose of this study is to investigate the safety of OPC-262 administered orally in~     combination with another oral antihyperglycemic agent~   "
181193|NCT01193166|"~     The study will assess the use of paliperidone palmitate compared with oral antipsychotic~     treatment in delaying time to a protocol-defined treatment failure over 12 months, in~     patients diagnosed with schizophrenia who were recently released from an inpatient~     psychiatric hospital.~   "
181197|NCT01193114|"~     Aim 1. Identify specific targets and processes of intervention among homeless substance~     abusing mothers with children between the ages of 2 and 6 years from information collected in~     focus groups and assessment interviews. Translate that information for the refinement of the~     ecologically based treatment manual.~      Aim 2. Test the efficacy of the treatment in a nonrandomized pilot study and revise the~     manual based upon those findings.~      Aim 3. Test the efficacy of the experimental intervention compared to treatment as usual~     (TAU) in a randomized pilot, with the goal to improve maternal substance abuse problems,~     social stability, and mental health. It is expected that the experimental intervention will~     be associated with lower substance use and related problem behaviors than TAU.~      Aim 4. Test whether intended change processes (mediators) associated with the intervention~     produce the desired change in mother's substance use, social stability, and mental health. It~     is expected that self-efficacy will mediate substance use outcomes.~      Aim 5. Explore how length of homelessness, age and ethnicity of the mother predict treatment~     response (moderators).~      Aim 6. Explore the impact of the experimental intervention (Ecologically-Based Therapy)on~     interpersonal stress and child's mental health.~   "
181198|NCT01193101|"~     This study is a phase 2 study in patients with essential hypertension.~   "
181199|NCT01193088|"~     This project includes two projects. One is looking for new genes that cause Charcot Marie~     Tooth disease (CMT). The other is looking for genes that do not cause CMT, but may modify the~     symptoms a person has.~   "
181200|NCT01193075|"~     This is an observational longitudinal study to determine the natural history and~     genotype-phenotype correlations of disease causing mutations in Charcot Marie Tooth disease~     (CMT) type 1B (CMT1B), 2A (CMT2A), 4A (CMT4A), and 4C (CMT4C).~      The investigators will also be determine the capability of the newly developed CMT Pediatric~     Scale (CMT Peds scale) and the Minimal Dataset to measure impairment and perform longitudinal~     measurements in patients with multiple forms of CMT over a five year window~   "
181201|NCT01193062|"~     The primary purpose of the study is to evaluate the effect of PF-04995274 on cerebrospinal~     fluid levels of soluble Amyloid precursor protein fragments and Amyloid beta fragments~     following single oral dose in healthy volunteers. Safety and tolerability of PF-04995274~     single dose administration in healthy volunteers will also be assessed as part of the~     objectives.~   "
181202|NCT01193049|"~     The purpose of this study is to evaluate the relationship between upper and lower airway~     allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the~     following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2)~     cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive correlation~     between effects of prednisone versus placebo on Th2 cytokines in sputum and nasal exudates.~   "
181203|NCT01193036|"~     Objectives:~      The objective of this study is to develop a valid and reliable measure of the symptom burden~     experienced by patients with cancer experiencing disease-related skin problems and to~     delineate this burden over time.~      The Primary Aim is to develop and validate an M.D. Anderson Symptom Inventory (MDASI) module~     (the MDASI-Derm), compliant with FDA standards for patient-reported outcomes (PROs), to~     measure the severity of multiple symptoms and the impact of these symptoms on daily~     functioning in patients with cancer-related skin problems. We hypothesize that the MDASI-Derm~     will be valid and reliable for measuring the severity of multiple symptoms and the impact of~     these symptoms on daily functioning in patients with cancer-related skin problems.~      The Secondary Aims are:~        1. to develop a detailed description of the severity and interference with daily activities~          of symptoms experienced by patients with cancer-related skin problems;~        2. to assess the impact of symptom severity on standard function and quality of life (QOL)~          measures including both quantitative (Eastern Cooperative Oncology Group [ECOG]~          Performance Status, single-item QOL, and Skindex-16 scales) and qualitative measures~          (patient interviews);~        3. to evaluate the MDASI-Derm as an estimate of functional status and QOL in patients with~          cancer-related skin problems;~        4. to identify common clusters of symptoms and symptom patterns occurring over multiple~          measurement time points in patients with cancer-related skin problems;~        5. to define the qualitative symptom experience of patients with cancer-related skin~          problems;~        6. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring~          symptom severity and interference with daily activities over time in patients with~          cancer-related skin problems.~   "
181204|NCT01193023|"~     The purpose of this study is to document the prevalence and type of asynchronies incidence~     during invasive mechanical ventilation in pediatric patients breathing under pressure~     support.~      And to observe the impact of adjusting the expiratory trigger setting on asynchronies, and~     compare these incidences with asynchronies measured in pediatric patient breathing under NAVA~     system (Neurally Adjusted Ventilatory Assist).~   "
181205|NCT01193010|"~     This study is designed as a multi-center randomized controlled trial, comparing two groups of~     patients with symptomatic extra-articular malunited distal radius fractures. One group of~     patients will undergo corrective surgery of the distal radius, with preoperative~     computer-assisted planning and virtual osteotomy, and the other group will undergo corrective~     surgery, with conventional (non-computer-assisted) preoperative planning. The investigators~     hypothesize that computer-assisted surgical planning will result in a better functional~     outcome.~   "
181206|NCT01192997|"~     There is evidence of waning immunity in individuals vaccinated against meningitis C as part~     of the UK infant immunisation schedule. The intention of this study is to contact~     participants of a previous NVEC (National Vaccine Evalutaion Consortium) clinical trial (a~     PreSchool Men C trial, in which participants were randomised to receive Meningitec, Menjugate~     or Neisvac-C). They will be invited to enrol and will be randomised to receive one of two~     quadrivalent meningococcal ACWY vaccines, to look at the boosting effect they may confer.~   "
181207|NCT01192984|"~     The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered~     eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell~     lymphoma. The primary objective is to assess the antitumor effect in terms of best overall~     response, while the secondary objectives are to assess the antitumor effect in terms of best~     response by disease lesion, to assess the progression-free survival and to assess the overall~     survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.~   "
181208|NCT01192971|"~     This phase II trial will be studying how well Apatinib working in patients with liver cancer.~   "
181209|NCT01192958|"~     At present influenza immunity can only be reliably confirmed by a blood test. This test is~     invasive for the patient. This study is intended to validate an oral fluid/saliva antibody~     test for the variant Swine Influenza H1N1. If such a test were available, this painless and~     non invasive test will improve direct clinical care to an individual as well as significantly~     help guide future public health management of the pandemic.~   "
181210|NCT01192945|"~     The purpose of this non-interventional study is to collect data on the efficiency and safety~     of Azacitidin in the routine application.~   "
181248|NCT01192451|"~     The Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter~     prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing~     domiciliary noninvasive positive pressure ventilation.~   "
181211|NCT01192932|"~     Computed tomography (CT) studies considering bronchial dimensions in chronic obstructive~     pulmonary disease (COPD) have never considered nycthemeral variations. Airway calibre, in~     COPD patients, exhibits a nycthemeral variations with maximal values around noon and minimal~     values in the early morning, that persists under long-acting bronchodilator. Furthermore, no~     study has assessed the possible nycthemeral variations of CT scans parameters reflecting~     airway remodelling and emphysema extent in COPD patients.~      This is a prospective study whose purpose is to assess these variations and their~     relationships with pulmonary function testing (PFT) in COPD patients.~   "
181212|NCT01192919|"~     Overview of treatment reality in patients with bronchial carcinoma requiring systemic~     treatment and being treated by office-based oncologists in Germany.~   "
181213|NCT01192906|"~     This multi-center, randomized, double blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent,~     predominant negative symptoms of schizophrenia. Patients, on stable treatment with~     antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching~     placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.~   "
181214|NCT01192893|"~     Oxytocin is a neurohypophysial hormone involved in several central and peripheral functions~     including parturition, milk let-down reflex and social behaviour. In vitro and animals~     studies have shown growing evidence that oxytocin plays a role in bone remodeling and~     osteoporosis. The investigators have previously show in a small sample of post-menopausal~     women with severe osteoporosis (n=20) compare to healthy control (n=16) that oxytocin serum~     level is significantly decreased, independently of leptin and estradiol, that are known to~     modulate oxytocin secretion. Thus, oxytocin appears as a new interesting factor in the~     osteoporosis pathophysiology. The aim of the present study is to confirm the relationships~     between bone status, evaluated by bone mineral density and prevalent fragility fractures,~     body composition and oxytocin serum levels on a large population. The investigators will also~     determine if the relationship between bone mineral density and oxytocin is independent of~     estradiol and leptin in this population and evaluate the relationships between oxytocin serum~     level and co-morbidities such as cardiovascular diseases, depression and dementia. Theses~     analysis will be done on the serum already available of 1000 women of the international OPUS~     cohort. Bone mineral density, body composition analysis by Dual energy X-ray Absorptiometry~     (DXA), estradiol and clinical data are already available. The investigators will select~     women, aged from 55 to 79 y at the time of inclusion.~   "
181215|NCT01192880|"~     This Phase 3, multi-center, randomized, double blind, parallel-group, placebo-controlled~     study will evaluate the efficacy and safety of RO4917838 (bitopertin) in participants with~     persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment~     with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching~     placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.~   "
181216|NCT01192867|"~     This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant~     negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics,~     will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks~     (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional~     treatment extension for up to 3 years. After 52 weeks, participants who were originally~     randomized to an active treatment will be randomly assigned to receive either placebo or~     continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to~     Week 56) for the assessment of potential withdrawal effects in a blinded manner using~     participants staying on active treatment as a control. Participants initially randomized to~     placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in~     the washout period will return to their blinded, active treatment arm.~   "
181217|NCT01192854|"~     Randomized, double blind parallel group, positive control, multi-center trial. Patients will~     be randomized at 1:1 ratio in group A or group B~   "
181218|NCT01192841|"~     Governmental agencies in the United Kingdom and Scotland have recently instituted guidelines~     banning physicians' white coats and wearing of long-sleeved garments to decrease hospital~     transmission of bacteria. The purpose of this study is to compare the bacterial contamination~     of physicians' white coats with that of newly laundered, standardized short-sleeved uniforms~     after an eight-hour workday and to determine the rate at which bacterial contamination of the~     uniform ensues. Our hypothesis was that the physician white coat would have more bacterial~     contamination at the end of the work day.~   "
181219|NCT01192828|"~     Cystathionine beta-synthase deficiency is an inherited disease that results in elevation of a~     substance called homocysteine (Hcy) in blood and urine. Individuals with this disorder have a~     very high risk for developing blood clots and are at risk for developing eye and bone~     abnormalities. Current treatments are generally difficult to follow and can fail. Development~     of additional therapies has been limited by lack of understanding of how the disease works.~      The purpose of this study is to see if oxidative stress and inflammation are involved in the~     disease process and if short-term supplementation with taurine is an effective treatment.~      Funding source: FDA-OOPD~   "
181220|NCT01192815|"~     RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Erlotinib hydrochloride may also make tumor cells more~     sensitive to radiation therapy. Radiation therapy uses high-energy x- rays and other types of~     radiation to kill tumor cells. Giving erlotinib hydrochloride together with radiation therapy~     may be an effective treatment for patients with head and neck cancer.PURPOSE: This phase II~     trial is studying how well giving erlotinib hydrochloride together with radiation therapy~     works in treating patients with stage III-IV squamous cell cancer of the head and neck.~   "
181221|NCT01192802|"~     Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy~     in the school children population. The aim of this study is to evaluate the efficacy of the~     albendazole one versus two and three doses, in school children infected with intestinal~     helminth.~   "
181249|NCT01192438|"~     The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal~     therapy of biopsy confirmed low-risk prostate cancer.~   "
181250|NCT01192425|"~     Examine red and white blood cells of PNH patients with bone marrow failure syndromes.~   "
181222|NCT01192789|"~     Two-arm cluster randomized controlled trial located in Hala district, Pakistan to determine~     the impact of using Lady Health Workers (LHW) of National Program for Family Planning and~     Primary Health Care to diagnose and manage severe pneumonia with oral amoxicillin on~     treatment failure rates at day 6 among 2-59 month old children. LHWs in the control arm~     receive a refresher in standard pneumonia case management. LHWs in the intervention arm~     receive standard training that is enhanced to include training in the recognition of severe~     pneumonia and its home management with oral amoxicillin. Clusters are by Union Council (UC),~     administrator units consisting of 7 to 25 LHWs; each UC is randomized to either enhanced~     pneumonia case management with oral amoxicillin therapy (intervention) for severe pneumonia~     or standard case management and referral to the nearest health facility for treatment~     (control). Process indicators reflecting the LHW's ability to assess, classify and treat~     pneumonia in the intervention group and cost-effectiveness data is also being collected.~      Primary Hypothesis:~      Enhanced pneumonia case management and oral amoxicillin therapy for severe pneumonia~     delivered by LHWs in the community will result in a reduction in treatment failure among~     children 2 - 59 months of age with severe pneumonia who are treated by the LHW compared with~     those referred for care by the LHW.~      Secondary Hypotheses:~        1. The proportion of treatment failure, [persistence of lower chest indrawing (LCI) or need~          for second line treatment between day 3 and day 14], will be less in the intervention~          arm compared with the control arm.~        2. LHWs can adequately assess, classify, and treat severe pneumonia in 2 - 59 month old~          children, and adequately recognize and refer children who present with danger signs~          during initial antimicrobial therapy.~   "
181223|NCT01192776|"~     The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born~     at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72~     hours to 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to 32.0°C; and~     (4) cooling for 120 hours to 32.0°C. The objective of this study is to evaluate whether~     whole-body cooling initiated at less than 6 hours of age and continued for 120 hours and/or a~     depth at 32.0°C in will reduce death and disability at 18-22 months corrected age.~   "
181224|NCT01192763|"~     This phase I trial is studying the side effects of RO4929097 before surgery in treating~     patients with pancreatic cancer. RO4929097 may stop the growth of tumor cells by blocking~     some enzymes needed for cell growth. Giving RO4929097 before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed.~   "
181225|NCT01192750|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     recurrent and/or metastatic squamous cell cancer of the head and neck previously treated with~     cisplatin with or without cetuximab.~   "
181226|NCT01192737|"~     The purpose of this study is to measure the incidence of A/H1N1 Influenza infection in the~     mother and her child and to identify the determinants in pregnant women during pandemic~     period in three public maternities in Paris, France.~   "
181227|NCT01192724|"~     Because there is limited data about long-term efficacy and safety about short-term use of~     cilostazol adding to dual antiplatelet therapy in patients with long or multivessel coronary~     artery disease after 2nd generation DES implantation, especially in biodegradable polymer~     stent, the investigators will evaluate whether a 3-month use of cilostazol in addition to~     dual antiplatelet therapy effectively reduces clinical adverse outcome at 1 year in subject~     with long or multivessel coronary artery disease after biolimus-eluting stent implantation.~   "
181228|NCT01192711|"~     The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus calculator,~     an information technology and a telemedicine system based on the communication between health~     care professional and patient by SMS messages.~      Aim of the study is to compare an insulin regimen of insulin glargine + prandial insulin~     glulisine associated with a telemedicine system to teach CHO counting (DID) with the same~     insulin regimen administered according to usual practice.~   "
181229|NCT01192698|"~     The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in~     hepatitis C positive patients undergoing liver transplantation. The hypothesis is that~     patients who receive ribavirin immediately before transplant and intravenous interferon alfa~     2b during the anhepatic phase(while the liver is removed)will have sustained virologic~     response post liver transplant.~   "
181230|NCT01192685|"~     This a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient~     open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery~     Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this~     trial, up to fifty subjects will be consented. The primary purpose of the current study is to~     determine: 1) if changes in electrical activity of the brain measured by EEG in specific~     areas is associated with changes in the blood flow of the brain 2) Which areas of the brain~     show changes in electrical activity and treatment response.~   "
181231|NCT01192672|"~     The purpose of this study is to test whether disease-related expressive writing is effective~     in the treatment of Irritable Bowel Syndrome (IBS).~   "
181232|NCT01192659|"~     The purpose of this study is to identify risk factors for low lymphocyte count among patients~     with type 2 diabetes who are treated with oral antidiabetic drugs.~   "
181233|NCT01192646|"~     Background~      The maternal mortality ratio in Tanzania has been persistently high for ten years with no~     signs of the ratio going down.The Tanzania Demographic and Health Survey (TDHS) of 1999 and~     2005 estimate the maternal mortality ratio to be 528 and 578 per 100,000 live births~     respectively (TDHS 1999, TDHS 2004/05).The major direct causes include obstetric haemorrhage,~     obstructed labour, pregnancy induced hypertension, sepsis and abortion complications.~      Most deliveries (53%) in Tanzania occur outside the health facilities. Of these 53% of births~     that occur outside the health facilities 31% are attended by relatives, 19% by traditional~     births attendants (TBA) while 3% have no assistance at all. Though, the proportional of~     mothers delivering in health facilities (47%) and receiving skilled attendance at birth (46%)~     is low but more than 94 percent of women attend antenatal care (ANC) in health facilities at~     least once. This indicates that there are factors that impede these women delivering in the~     health facilities.~      Low awareness of obstetric danger signs may be one of the contributing factors for delay to~     decide to seek care when a complication occur thus contributing the first phase of delay.~     Studies in Tanzania show that most women are not aware of danger signs of obstetric~     complications during pregnancy, delivery and after delivery. A study conducted in Mtwara~     rural to assess the use and determinants of skilled attendants at delivery showed that~     proportional of women delivered with skilled care increases with increasing knowledge of~     pregnancy danger signs, but it also showed that few women have knowledge of pregnancy danger~     signs~      An increasing body of evidence supports the importance of community participation in maternal~     and infant health programs for establishing ownership, identifying problems effectively,~     achieving equity and helping to institutionalize health programs. To mount an effective~     maternal health effort aimed at reducing maternal and infant mortality, multiple levels of~     program and policies need to be in place and functioning. In addition, linkages, from the~     communities, local dispensaries and health centres to first referral hospitals that are~     adequately equipped, need to be developed and sustained~      A home based life saving skills (HBLSS) is a strategy that intends to educate pregnant women~     and their primary family caregivers and home birth attendants on critical knowledge and~     skills to keep a pregnant woman healthy, to recognize life-threatening maternal and newborn~     complications and promote the adoption of health care and health-seeking behaviours at the~     individual and community levels. The aim of this strategy is to prevent maternal and neonatal~     morbidity and mortality through creating awareness on women's birth preparedness and access~     to emergency obstetric care services~      RESEARCH QUESTIONS~        1. Can HBLSS increase women empowerment and male involvement in the decisions relating to~          access of emergency obstetric and newborn cares?~        2. Can the HBLSS increase hospital deliveries, increase awareness of obstetric and neonatal~          danger signs, birth preparedness and emergency readiness in a rural community?~      Objectives~      Broad Objectives:~        1. To investigate social-cultural, community and traditional practices that impact on~          women's birth preparedness and access and utilization of emergency obstetric care~          services in rural district.~        2. To assess the impact of home based life saving skills (HBLSS) on hospital delivery~          awareness of obstetric and neonatal danger signs, birth preparedness~      Specific Objectives~        1. To explore customs, taboos and practices including herbal remedies during pregnancy and~          labour that influence birth preparedness and utilization of emergency obstetric care~          services.~        2. To assess perception, attitude and health seeking behaviour when a complication occur.~        3. To determine the effect of HBLSS educational programme on hospital delivery, birth~          preparedness, emergency readiness and utilization of emergency obstetric care services~          among women in Rufiji district.~        4. To assess the impact of HBLSS educational programme on male awareness and involvement in~          assisting women on birth preparedness and access to emergency obstetric care services.~        5. To determine the cost-effectiveness of HBLSS educational programme~      Methodology~      A Cluster Randomized Trial~      28 clusters will be randomly selected, 14 clusters will receive HBLSS training and the other~     14 clusters will not receive HBLSS training.~   "
181234|NCT01192633|"~     The primary objective of this study is to evaluate PFS of gemcitabine,vincristine and~     cisplatin as second line therapy in patients with sarcoma. 40 patients will be treated into~     this study.~   "
181235|NCT01192620|"~     The purpose of this study is to test a standardized approach for children being evaluated for~     appendicitis in the emergency department. This means that all doctors would use the same~     approach to diagnose appendicitis in children in the emergency department. This pathway uses~     two scoring systems to identify patients who are at high and low risks of appendicitis. These~     scoring systems are based on the patient's symptoms, signs the doctor finds when examining~     the patient, and their blood tests. The goal of this part of the study is to determine if the~     investigators' pathway accurately identifies patients who have appendicitis.~   "
181236|NCT01192607|"~     The objectives of this Phase I study is to evaluate the safety and effectiveness of the~     endoscopic endodontic equipment device for root canal assistance treatment as well as to~     evaluate the ease of use of this device, by a surgeon experienced in endodontic treatment, in~     a true clinical setting.~   "
181251|NCT01192412|"~     The investigators do not know which approach to treatment of non-severe high blood pressure~     in pregnancy is better for women and babies.~      In the CHIPS Trial, the investigators seek to determine whether 'less tight' control (aiming~     for a diastolic blood pressure [dBP] of 100 mmHg), compared with 'tight' control (aiming for~     a diastolic blood pressure [dBP] of 85 mmHg) can decrease the risks of adverse baby outcomes~     without increasing the risk of problems for the mother.~   "
181252|NCT01192399|"~     A study to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic~     PNH.~   "
181237|NCT01192594|"~     This nested design clinical outcome study of psychiatric case manager education on disease~     state, psychopharmacology of schizophrenia, relapse, motivational interviewing, and the~     process of psychological adjustment post-psychosis (Milestones of Adjustment Post-Psychosis~     Recovery Model-MAPP) will test the following hypotheses:~        1. Medication non-adherence in patients with schizophrenia assigned to case managers who~          receive MAPP training will decrease from their pre-study rate and from the reported~          national average after one year enrollment compared to consumers not enrolled in the~          MAPP arm of the study.~        2. Consumers in the MAPP intervention will have higher Quality of Life Enjoyment and~          Satisfaction Questionnaire (Q-Les-Q (53) scores than consumers not enrolled in the MAPP~          at quarterly measures.~        3. Consumers enrolled in the MAPP intervention arm of the study will successfully complete~          the first two phases of the MAPP Recovery Model in one year.~        4. Consumers in the MAPP intervention arm will have greater symptom reductions at quarterly~          data points compared to consumers not enrolled in the MAPP intervention arm.~   "
181238|NCT01192581|"~     The aim of this study is to evaluate the effectiveness, safety and tolerability of consistent~     dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride injection,~     Vuloven) administrated intravenously for 7 days.~   "
181239|NCT01192568|"~     This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in~     children 3 to less than 17 years old, who have overactive bladder due to a neurogenic~     condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then~     return to the clinic for a potential dose titration. At this time their dose may be adjusted~     up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the~     individual response and tolerability. The total treatment time is 14 weeks and total time on~     the study is 16 weeks.~   "
181240|NCT01192555|"~     Neuroblastoma is the second most common solid tumor seen in children, but causes~     approximately 15% of childhood cancer deaths each year. Patients with high-risk disease~     require treatment with a combination of chemotherapy, surgery, radiation, and stem cell~     transplant; however, many will have their disease come back within 3 years. Due to this high~     rate of relapse, this study is being done to investigate an experimental treatment option for~     children whose disease has returned.~      This clinical trial is for patients with neuroblastoma that has either come back after~     treatment or never went away in the first place. A series of immunizations will be~     administered using a tumor vaccine and add low-dose chemotherapy to be taken by mouth on a~     daily basis. The hope is that the vaccine will cause the immune system to recognize and kill~     more types of neuroblastoma tumors. Additionally, the immunizations will be combined with~     daily low dose chemotherapy. Daily low-dose chemotherapy, also know as metronomic~     chemotherapy, works by attacking the blood vessels that allow tumors to grow. Using~     metronomic doses of a drug called cytoxan can also decrease T regulatory cells, a specific~     type of cell that tumors use to hide from the immune system.~      The purpose of this study is to test the safety and anti-tumor effect of the tumor cell~     vaccination plus low dose, metronomic chemotherapy in treating patients with~     relapsed/refractory neuroblastoma.~   "
181241|NCT01192542|"~     The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the~     new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven~     (7) days.~   "
181242|NCT01192529|"~     The most common symptoms associated to senile dementia disease are confusion about schedules,~     hyperactivity... In this sense, these patients have frequently poor nutrition, resulting in~     malnutrition problems or malnutrition high risk.~   "
181243|NCT01192516|"~     The primary objective of this project is to examine effectiveness of a tailored pacing~     intervention on fatigue, pain, and physical function compared to general pacing intervention~     and usual care groups. A secondary objective is to evaluate the natural history of symptoms~     and physical disability over time among people with knee and hip osteoarthritis.~   "
181244|NCT01192503|"~     The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to~     make sure rasagiline is safe to give people with RLS.~   "
181245|NCT01192490|"~     The hypothesis of this study is that topical cervical and intra-cervical lidocaine will~     decrease pain associated with the insertion of a Mirena® (levonorgestrel intrauterine~     device).~      1. Primary Aim- Determine if topical lidocaine intra-cervically and on the cervix decreases~     the pain associated with insertion of a Mirena® (levonorgestrel intrauterine device).~   "
181246|NCT01192477|"~     Increases in air pollution are associated with increases in deaths from cardiovascular~     disease, but the investigators know little about how ozone air pollution affects the~     cardiovascular system. The investigators proposed study will determine the effects of ozone~     on blood vessel and heart function that could worsen illness in people with underlying heart~     disease. This will be accomplished by studying healthy volunteers who inhale ozone in a~     controlled clinical study, and also by studying their exposure to ozone and other pollutants~     during their normal daily activities. The investigators will study volunteers who may be at~     increased risk for the effects of ozone because of genetic susceptibility. Understanding the~     effects of ozone on the heart and circulation can help establish appropriate air pollution~     standards, and provide strategies to protect the most susceptible people.~   "
181247|NCT01192464|"~     The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. Antibodies are proteins the protect the body from diseases caused by~     germs or toxic substances. They work by binding those germs or substances, which stops them~     from growing and causing bad effects. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including tumor cells or cells that~     are infected with germs. Both antibodies and T cells have been used to treat patients with~     cancers: they both have been shown promise, but have not been strong enough to cure most~     patients. This study combines the two methods.~      We have found from previous research that we can put a new gene into T cells that will make~     them recognize cancer cells and kill them. We now want to see if we can attach a new gene to~     T cells that will help them do a better job at recognizing and killing lymphoma cells.~      The new gene we will put in T cells makes an antibody called anti-CD30. The antibody alone~     has not been strong enough to cure most patients. For this study, the anti-CD30 antibody has~     been changed so that instead of floating free in the blood it is now joined to the T cells.~     When an antibody is joined to a T cell in this way it is called a chimeric receptor. These~     chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long and~     so their chances of fighting the cancer are unknown.~      We have found that T cells that are also trained to recognize the EBV virus (that causes~     infectious mononucleosis) can stay in the blood stream for many years. These are called EBV~     specific Cytotoxic T Lymphocytes.~      By joining the anti-CD30 antibody to the EBV CTLs, we believe that we will also be able to~     make a cell that can last a long time in the body and recognize and kill lymphoma cells. We~     call the final cells CD30 chimeric receptor EBV CTLs. T~      We hope that these new cells may be able to work longer and target and kill lymphoma cells.~     However, we do not know that yet.~   "
181253|NCT01192386|"~     Inflammatory proteins from eosinophil granulocytes in blood from patients with seasonal~     allergic hayfever have been shown to predict development of asthma at a six-year follow-up.~     This study is a 15-year follow-up of the same patients to verify earlier results and study~     disease development.~   "
181254|NCT01192373|"~     The investigators wish to investigate the the short term effect of low circulating free fatty~     acids in congestive heart failure patients with type 2 diabetes.~      Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral~     muscle lipid content, improves cardiac performance and exercise capacity.~   "
181255|NCT01192360|"~     The primary objective of this study is to determine if quantitative Dynamic contrast-enhanced~     magnetic resonance (DCE MR) perfusion imaging accurately quantifies right and left pulmonary~     artery blood flow as compared with phase contrast flow velocity mapping (PC), the current~     gold standard of flow volume measurements.~   "
181256|NCT01192347|"~     This is an observational study to explore how different treatment regimens affect~     continuation with treatment in the first 6 months following initiation of XAGRID into adult~     patients' essential thrombocythemia therapy.~   "
181257|NCT01192334|"~     It was well known that total knee arthroplasty could improve the previously impaired~     proprioception in degenerative osteoarthritis. Most current researches have been focused on~     the change of the proprioception. However, the evaluation of the proprioception is based on~     the surrogated end.~      Double or single limb standing balance is considered functional scale. It is very important~     view for the prevention of slipping down injury in evidence-based approaches for knee~     osteoarthritis.~      Unfortunately, few study have been performed for figuring proprioceptive change after surgery~     out.~      Considering the similarity between the proprioception and the standing balance and reported~     positive result in proprioception after total knee arthroplasty, the investigators supposed~     that total knee arthroplasty might give an influence on the recovery of single limb standing~     balance.~   "
181258|NCT01192321|"~     The objectives of this study are to assess and compare bilateral uncorrected distance visual~     acuity and distance spectacle independence post bilateral implantation of AcrySof Toric~     Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of~     eyeglass purchased and patient vision-related quality of life.~   "
181259|NCT01192308|"~     All women on tamoxifen receive the standard dose of 20mg QD, irrespective of the use of~     potential CYP2D6 inhibitors, and are not tested for CYP2D6 polymorphisms prior to start of~     tamoxifen treatment.However CYP2D6 polymorphisms and/or the use of CYP2D6 inhibitors as~     co-medication may influence the treatment outcome of tamoxifen.~      The investigators propose a prospective study in women taking tamoxifen at a dose of 20mg QD.~     In each woman, information will be collected on endoxifen levels, CYP2D6 status, adherence~     and use of co-medication. In women who are phenotypically poor metabolizers of tamoxifen, a~     dose increase to 40mg QD will be applied and the effect of this intervention on tamoxifen~     pharmacokinetics will be evaluated after 4 weeks.~   "
181260|NCT01192295|"~     The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl)~     controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years,~     inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid~     therapy.~   "
181261|NCT01192282|"~     This is a longitudinal observational study of women presenting to Groote Schuur Hospital with~     genital warts. The study will evaluate the socio-demographic characteristics of the women~     using a structured questionnaire. It will also document the site and extend of the genital~     warts and genotyping will be performed on the warts. HIV status will be determined with~     patient consent, treatment modalities will be documented as will the outcome of treatment~     over a 6 month's period. Risk factors for recurrence or failure of treatment will be analysed~     as will the costs of treating women with genital warts.~   "
181262|NCT01192269|"~     Various biological materials have been investigated to determine dietary fatty acid intakes,~     such as plasma, erythrocytes, and adipose tissue. The applied techniques are invasive~     sampling methods and may have limitations in studies involving infants or young children. In~     1985 the group of McMurchie suggested buccal cheek cells as a marker for dietary fatty acid~     intake; however fatty acid profiling in cheek cells has not been widely used yet.~      In a clinical intervention trial a new method will be tested. The study will consist of two~     consecutive parts: A) a correlation study will investigate the relationship between~     established fatty acid markers (red blood cells (RBC), plasma) and the newly proposed markers~     (cheek cells) before and after intervention B) an intervention study will investigate the~     time depended implementation and steady state of docosahexaenoic acid DHA in plasma, RBC and~     cheek cells.~      The participants will receive 520 mg DHA daily over a period of 30 days. Blood and cheek cell~     samples will be collected once prior to study commencement and regularly during intervention.~      The proposed study aims at verifying cheek cell analysis results as a non-invasive marker for~     fatty acid profiling. This will be shown by correlation analyses of fatty acids in cheek~     cells, erythrocytes and plasma phospholipids. Furthermore, the time kinetics of DHA~     incorporation into cheek cells will clarify if cheek cell fatty acids can be considered as a~     short or long term marker.~      The new non-invasive method is expected to be extremely valuable as a non-invasive approach~     for studying the fatty acid profile in human, including infants and young children.~     Therefore, it is of great interest to validate the new method in a clinical trial.~   "
181263|NCT01192256|"~     A large project consisting of:~      a) an observational trial where smoking status is recorded on 1400 consecutive people newly~     diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon~     monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment~     complications will be recorded and compared in smokers, ex-smokers and never smokers.~   "
181264|NCT01192243|"~     The purpose of this study is to examine the efficacy and safety of gefitinib combinated with~     Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).~   "
181265|NCT01192230|"~     The purpose of this study is to examine the efficacy and safety of endostatin combined with~     Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or~     second-line chemotherapy.~   "
181310|NCT01191645|"~     The purpose of this study is to determine whether a dopamine receptor antagonist~     metoclopramide can counteract opioid induced effects on esophageal motility and lower~     esophageal sphincter. The aim of this study is also to evaluate if the opioid antagonist~     naloxone reduces the opioid induced pharyngeal and esophageal dysfunction.~   "
181266|NCT01192217|"~     The investigators conducted a prospective randomized study to compare axillary~     minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis~     in patients with recurrent spontaneous pneumothorax operated in a single institution.~      The main objective of the study was to investigate possible differences regarding short- and~     long-term clinical outcome between the two different techniques.~   "
181267|NCT01192204|"~     This is a multicenter placebo-controlled clinical trial to assess the effects of a topically~     applied gel on precancerous oral epithelial lesions. A total of 41 participants will be~     enrolled in this trial, and 22 of them will be enrolled at Ohio State. [The remaining 19~     participants will be enrolled at the University of North Carolina (9 participants) and the~     University of Louisville (8 participants)]. At all three institutions, half of the~     participants will randomly be assigned to the 10% FBR gel (0.5 gm four times daily for 3~     months), while half will enter the placebo control arm. All trial participants will have a~     pretreatment (including lesional and perilesional tissue) biopsy taken before and an~     excisional biopsy after 3 months of treatment. As pretreatment indices are compared to post~     treatment effects on each patient, patients serve as their own internal control. Pretreatment~     lesional biopsies are obtained to establish a pretreatment diagnosis and provide a~     pretreatment baseline for the experimental parameters.~   "
181268|NCT01192191|"~     The primary purpose of the study is to evaluate the safety and tolerability of fluticasone~     furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese~     patients with COPD.~   "
181269|NCT01192178|"~     Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel~     group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma~     exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316~     subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments~     using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment~     starting in April 2010. Eligible subjects will be invited to return for randomization into~     the study in August 2010. This exploratory study is being conducted to assess whether~     treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of~     exacerbation and the asthma impairment associated with viral respiratory tract infections~     during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.~   "
181270|NCT01192165|"~     The purpose of this study is to determine what dose of GSK1120212 can be given safely in~     combination with at least one other drug that is already approved to treat cancer. This study~     will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212~     plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed +~     cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future~     trials to test whether the combination treatment is a safe and effective therapy for subjects~     with metastatic lung and/or pancreatic cancers.~   "
181271|NCT01192152|"~     The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg~     metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt~     Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured~     in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in~     Evansville, Indiana) in the fed state in healthy subjects.~   "
181272|NCT01192139|"~     The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg~     metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt~     Vernon, Indiana [IN]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet~     (manufactured in Evansville, IN) in fed healthy subjects.~   "
181273|NCT01192126|"~     The objective of the study is to evaluate the product performance of visual acuity of the~     Bausch + Lomb investigational daily disposable contact lenses compared to the currently~     marketed Johnson & Johnson Acuvue Moist contact lenses.~   "
181274|NCT01192113|"~     This is an open-label, randomized, multi-center clinical trial to evaluate the safety and~     efficacy in peripheral neuropathies patients treated with Mecobalamin Injection~   "
181275|NCT01192100|"~     The purpose of this study is to assess whether the daily addition of a protein-rich breakfast~     leads to beneficial changes in appetite control, food intake regulation,and cognitive~     function in overweight & obese 'breakfast skipping' young women.~   "
181276|NCT01192087|"~     The ACCEPT (A(denoid) c(ystic) c(arcinoma), E(rbitux, and) p(article) t(herapy))-trial is a~     prospective, monocentric phase I/II feasibility trial evaluating toxicity and efficacy in the~     combined treatment of intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost~     with the epidermal growth factor receptor (EGFR) antibody cetuximab. The primary objective of~     the study is to explore the toxicity of the combined modality regimen consisting of heavy ion~     therapy / IMRT and EGFR antibody immunotherapy, by assessing the rate of patients with~     mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4.~     Secondary endpoints include local control, distant control, overall disease-free survival,~     overall survival~   "
181277|NCT01192074|"~     This is a data base building project on the use of pre-procedure ultrasound for the~     performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries. Data~     collection includes ultrasound measured depth, actual needle depth, angle of ultrasound~     probe, actual needle angle, success rates, patient height and weight, number of attempts~     needed to place the epidural needle or spinal needle. Currently we are looking at the~     agreement between ultrasound determined depth of the epidural space or intrathecal space with~     actual needle depth.~   "
181291|NCT01191892|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet~     known whether giving carboplatin and gemcitabine hydrochloride is more effective with or~     without vandetanib as first-line therapy in treating urinary tract cancer.~      PURPOSE: This randomized phase II trial is studying giving carboplatin together with~     gemcitabine hydrochloride and to see how well it works when given with or without vandetanib~     as first-line therapy in treating patients with locally advanced or metastatic urinary tract~     cancer.~   "
181292|NCT01191879|"~     The purpose of this study is to compare p53-induced genes activation as possible markers~     differentiating between patients presenting with acute myocardial infarction and controls.~   "
181278|NCT01192061|"~     Evidence has accumulated that systemic and ocular mechanisms, responsible for regulating~     blood flow in the area of the optic disc, such as reduced ocular perfusion pressure, abnormal~     autoregulation and vascular dysregulation may be involved in the pathogenesis of normal~     tension glaucoma (NTG). Defective cardiovascular neuroregulation has been advocated as a~     possible one of the main systemic contributing factors in the etiology of NTG. Based on the~     results of previous studies, the hypothesis has been posed that patients with NTG have an~     impaired diurnal heart rate variability (HRV) or high activity of the sympathetic component~     of autonomic nervous system (ANS) and endothelial dysfunction. Impaired balance of ANS,~     resulting in increased demand for oxygen in the tissues and subsequent low threshold of~     hypoxia in all organs (including the eye) can be an important link in the pathogenetic~     pathway of NTG, making the optic nerve more sensitive to small and short-term changes in~     perfusion pressure and prone to damage even under a statistically normal intraocular~     pressure (IOP).~      The aim of this study is to evaluate the activity and characteristics of the following~     systems: the central ANS (through a 24-hour analysis of heart rate variability and blood~     pressure), peripheral vascular system (through the analysis of the post-occlusive hyperemia~     reaction within the distal part of left upper limb) and the local retrobulbar circulation as~     measured by color Doppler imaging (CDI) in patients with NTG and healthy volunteers. The~     correlations between all above systems, as well as between them and the structural and~     functional parameters of the optic nerve, and the retina in both groups will be also~     analyzed.~   "
181279|NCT01192048|"~     Congenital heart disease (CHD) is the most common type of birth defect but the cause for the~     majority of cardiac birth defects remains unknown. Numerous epidemiologic studies have~     demonstrated evidence that genetic factors likely play a contributory, if not causative, role~     in CHD. A few genes have been identified by us and other investigators using traditional~     genetic approaches, but these genes only account for a small portion of the non-syndromic~     CHDs. Therefore, we are now utilizing whole exome sequencing (WES), with the addition of more~     traditional genetic techniques such as chromosomal microarray or traditional linkage~     analysis, to identify genetic causes of familial and isolated CHD. With WES we are able to~     sequence all of the genes of an individual and apply different data analysis techniques based~     on whether we are analyzing a multiplex family or a cohort of trios (mother, father and child~     with CHD) with a specific isolated CHD. Therefore, WES is a robust method for identification~     of novel genetic causes of CHD which will have important diagnostic and therapeutic~     consequences for these children.~   "
181280|NCT01192035|"~     BACKGROUND: Since 1996 the combination of three or more drugs has been the mainstay of human~     immunodeficiency virus (HIV) treatment. The most important types of drugs are called~     nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleotide reverse transcriptase~     inhibitors (NNRTIs) and protease inhibitors (PIs) Response to treatment is measured as~     increasing CD4+ cell count and decreasing HIV viral load. A major problem is the development~     of resistance. NNRTIs are recommended as part of first-line treatment of HIV in Africa but~     many Africans have a slower NNRTI clearance than Caucasians making them more susceptible for~     development of resistance in case of treatment interruptions. PIs might therefore be a better~     option in an African setting with low adherence.~      AIM: To evaluate two different treatment regimens in HIV-1 infected patients:~      A) A NNRTI (efavirenz/nevirapine) based regimen and B) A PI (ritonavir-boosted lopinavir)~     based regimen with regard to treatment outcomes. HYPOTHESIS: Treatment with a PI will be~     superior to treatment with a NNRTI due to less development of resistance.~      METHODS: Treatment-naïve adult HIV-1 patients enrolled in an existing cohort The West African~     Retrovirus and Acquired Immune Deficiency (WARAID) cohort in Guinea Bissau with CD4+ cell~     count ≤ 350 cells/µL and/or clinical signs of immune suppression (World Health Organization~     (WHO) clinical stage 3 or 4) will be randomised 1:1 to: Treatment A: 2 NRTIs (lamivudine and~     either zidovudine or stavudine) and 1 NNRTI (efavirenz or nevirapine) or Treatment B: 2 NRTIs~     (same as in treatment A) and 1 PI (ritonavir-boosted lopinavir). Primary outcome: Viral load~     suppression <400 copies/ml 12 months after enrolment.~      PERSPECTIVES: Guidelines for treatment of HIV in Africa are more or less a copy of the~     guidelines used in Europe and North America. Genetic differences in pharmacokinetics, more~     women infected in Africa and difficulties ensuring good adherence mean that results obtained~     from Caucasian patients are not directly transferrable to African patients. The results of~     this study will hopefully help guiding the treatment of HIV in Africa in the future. The~     investigators believe the HIV infected people in West Africa deserve the same evidence-based~     medicine as in developed countries.~   "
181281|NCT01192022|"~     The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection~     surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.~     Hemostatic efficacy will be evaluated intraoperatively after application of randomized~     treatment.~   "
181282|NCT01192009|"~     Leucine supplementation is widely known for promoting strong influence on skeletal muscle~     remodeling. This study aims to evaluate the effect of leucine supplementation on~     disuse-induced skeletal muscle atrophy.~   "
181283|NCT01191996|"~     The purpose of the study is to determine the safety and tolerability, dose-limiting~     toxicities, maximum tolerated dose, and recommended therapeutic dose of intravenously~     administered MIS416 weekly in patients with chronic progressive multiple sclerosis.~   "
181284|NCT01191983|"~     This single arm, open label study will assess the efficacy, safety and tolerability of~     methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in~     participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are~     not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will~     receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The~     starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta~     will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28~     weeks.~   "
181293|NCT01191866|"~     Primary Objective is to evaluate the influence of psychosocial interventions in the treatment~     of children and adolescents with type 1 diabetes mellitus by measuring the connection between~     these interventions to quality of life and to metabolic control. Secondary Objective is to~     provide an opportunity, through quality of life (QOL) questionnaires, for enhanced~     communication between the patient, family and diabetes care team and also an opportunity to~     resolve negative issues.~   "
181311|NCT01191632|"~     The efficiency of T cell based immunotherapies is affected by the insufficient migration and~     activity of tumor specific effector T cells in the tumor. Aim of this phase I/II clinical~     trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve T cell~     connected anti tumor immune response in colorectal liver metastases.~      The primary endpoint is the number of tumor infiltrating T cells. Furthermore the T cell~     activity in situ, the number of regulatory T cells and the frequency of tumor reactive T~     cells in the blood and bone marrow will be examined.~   "
182069|NCT01181674|"~     The purpose of this pilot trial is to determine whether an intensive treatment with insulin~     glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients~     with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.~   "
181285|NCT01191970|"~     Presently, the literature addressing the relationship between epidural analgesia and~     likelihood of breast-feeding is inconclusive. Numerous studies have found that epidurals,~     administered prior to vaginal delivery of a full-term, healthy neonate, significantly~     decrease lactation success at follow-up times ranging from 24 hours to 6 months postpartum.~     One proposed mechanism is that analgesics, by decreasing maternal pain during labor, decrease~     maternal endorphin production and result in the transmission of lower endorphin levels to the~     neonate during breast-feeding. Lower endorphin levels, in turn, may render the neonate less~     likely to suckle optimally. Other studies have found that epidural analgesia does not~     significantly decrease lactation success when used during the vaginal delivery of a~     full-term, healthy neonate.~      Although most studies to date have compared the breast-feeding success of epidural recipients~     and non-recipients at various points postpartum, they do not specifically note whether~     deficient feeding behaviors on the part of the infant contribute to failed breast-feeding.~     The present study uses the LATCH assessment tool to score the infant's ability to latch onto~     the breast and the presence of audible swallowing, as well as the mother's level of physical~     comfort with breast feeding, whether she can successfully position the infant for feeding on~     her own, and whether her nipples are inverted, everted, or flat. Thus, the LATCH assessment~     enables the separation of multiple factors that may contribute to breast-feeding failure. A~     multivariate regression analysis will determine how strongly the probability of~     breast-feeding at hospital discharge correlates with epidural duration, LATCH scores, and~     beta-endorphin concentrations in colostrum.~   "
181286|NCT01191957|"~     The purpose of this prospective phase III, open-label, randomized multicenter study is to~     evaluate whether Acute Myeloid Leukemia (AML) elderly patients in Complete Remission (CR)~     undergoing allogeneic hematopoietic stem cell transplantation after a reduce toxicity~     conditioning regimen (I.V. BuFlu) as compared to the conventional I.V.~      BuCy2 program will experience:~        1. A lower transplant-related mortality (TRM) at 1 year after Hematopoietic Stem Cells~          Transplant (HSCT)~        2. A similar anti-leukemic activity and a similar or better safety profile, in terms of:~             -  Early and/or late graft rejection~             -  Hematopoietic and immunologic recovery~             -  Chimerism~             -  Toxicity and incidence of Veno-occlusive Disease (VOD)~             -  Acute (aGvHD) and chronic graft-versus-host disease (cGvHD)~             -  Cumulative incidence of TRM at +100 days and 2 years after transplant~             -  Cumulative incidence of relapse by 1 and 2 years after transplant~             -  Event-free (EFS) and overall survival (OS) by 1 and 2 years after transplant~   "
181287|NCT01191944|"~     The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to~     Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease~     Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .~   "
181288|NCT01191931|"~     Study design:~      -The study will be a phase I like study to assess the extent to which prostate HistoScanning~     (PHS, the index test) can identify and characterize foci of prostate cancer when compared to~     histological samples harvested during radical prostatectomy (the reference test). The study~     will comprise 3 steps: first, defining the most suitable method for matching the TRUS~     (TransRectalUltrasonography) to histology (step 1); second, refining the algorithms (training~     set); third, verification of the PHS performances (test set).~      Study objectives:~        -  Primary Objective:~             -  To evaluate the extent to which PHS can discriminate between malignant lesions of~               the prostate versus non-malignant tissue in 3D RF TRUS data using radical~               prostatectomy histological step sectioning as the reference test.~        -  Secondary Objectives:~             -  To adapt and refine PHS tissue characterisation algorithms using RF data that were~               previously developed using grey-level data as input.~             -  To assess the accuracy of PHS in predicting the volume of prostate cancers~               determined by histology.~             -  To assess the ability of PHS to rule in or rule out the presence of cancer > or =~               0.5 cc and of > or = 0.2 cc as determined by histology.~             -  To evaluate the ability to discriminate primary Gleason pattern 4 and 5 versus 3 or~               less in tumours > or = 0.5 cc and > or = 0.2 cc.~             -  To assess the ability of PHS to correctly risk stratify patients.~   "
181289|NCT01191918|"~     There is a high rate of partial response to standard thymoleptic medication. In this study~     the investigators want to evaluate the safety and efficacy of donepezil as adjunctive~     treatment to mood stabilizers in bipolar disorder with acute mania. The investigators~     hypotheses were that there would be greater mean reduction in manic symptoms with donepezil~     augmentation of lithium compared with placebo.~   "
181290|NCT01191905|"~     Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is~     known to be an independent risk factor for mortality. Among the various etiologies of AKI,~     sepsis or septic shock is the most frequent contributing factor especially in an intensive~     care unit setting. Also, the mortality of septic AKI in these patients still remains~     extremely high despite recent marked therapeutic advance.~      Given the physiologic superiority of continuous renal replacement therapy (CRRT) on uremia~     and volume control, it has become the modality of choice in critically ill patients with AKI.~     In addition, CRRT can theoretically provide immunohomeostasis through the convective and~     adsorptive removal of various immune mediators. Although the pathophysiology of septic AKI~     remains elusive, it has become increasingly recognized that many pro- and anti-inflammatory~     mediators, such as TNF, IL-6, IL-8 and IL-10, play an important role in this process.~     Therefore, it has been speculated that the reduction of cytokines by increasing CRRT dose in~     patients with septic AKI may reduce mortality risk. Even though recent two large scale~     randomized controlled trials, ATN and RENAL study, have failed to show the difference in~     survival rate between the clearance of 20~25 ml/kg/hr and 35~40 ml/kg/hr, none of these~     studies were designed to elucidate the survival benefit of high intensity CRRT in patients~     with septic AKI. Moreover, the optimal target CRRT dose in these patients is not well~     established and may be even higher than 35~40 ml/kg/hr in terms of septic AKI. Indeed, recent~     several uncontrolled trial have shown the survival benefit of high intensity CRRT in these~     patients.~      To further explore the effects of high dose CRRT on survival of critically ill patients with~     septic AKI, the investigators will conduct a multicenter prospective randomized controlled~     open-label trial which compares the difference in survival rate between 1:1 balanced~     pre-dilution CVVHDF at 80 vs. 40 mL/Kg/hr for initial 72hrs after the start of CRRT. The~     primary end-point of this study is the effect of high volume pre-dilution CVVHDF on 28-day~     survival rate. The secondary end-point is 60- and 90-day mortality, ICU and in-hospital~     mortality, duration of CRRT and renal replacement therapy, duration of mechanical~     ventilation, cytokine removal rate at 12h after the initiation of CRRT, and changes in SOFA~     and APACHE II score at 72h after the initiation of CRRT. This is a superiority trial which~     aims to demonstrate a reduction of 20% or more in mortality rate. For this purpose, at least~     109 subjects (a total of 218) would be required for each group if type I error rate is 5% and~     type II error is 20% given 25% of drop-out rate during the study period. Block randomization~     will be used by means of a dedicated website.~      There are still conflicting data on the optimal target dose of CRRT in patients with septic~     AKI. Our study will address this issue to answer the unresolved question on the effect of~     high dose CRRT.~   "
182070|NCT01181661|"~     The purpose of the study is to develop and test an Internet-based group contingency~     management program designed to promote smoking cessation.~   "
181294|NCT01191853|"~     Background:~      - Seasonal influenza is a major health problem whose impact is typically reduced by~     vaccination. The H1N1 (swine flu) influenza virus is an emerging pathogen that has the~     potential to cause devastating illness and even death in the coming months. Currently, there~     are limited data on the cellular and molecular immune responses in adult recipients of either~     the seasonal or the H1N1 influenza vaccines.~      Objectives:~      - To obtain blood and nasal wash samples and perform laboratory studies to characterize the~     immune response in healthy adult volunteers at baseline and after immunization with the~     seasonal or H1N1 influenza vaccines.~      Eligibility:~      - Adult employees at least 18 years of age of the NIH Clinical Center who are deemed healthy~     by a brief medical history and physical examination and routine blood testing.~      Design:~        -  Before the start of the influenza season, volunteers will receive either the seasonal~          influenza vaccine or the H1N1 vaccine when it becomes available. If the H1N1 vaccine is~          available at the start of the season, volunteers will receive both the seasonal vaccine~          and the H1N1 vaccine.~        -  Blood will be drawn over an 8-week period. Volunteers must not eat anything for 8 hours~          prior to the blood draw. The sequence of the blood draws is as follows: 2 weeks before~          vaccination; right before vaccination; and 1, 7, 14, 28, and 60 days after vaccination.~        -  Two to four nasal washings will be collected by a nurse before volunteers receive the~          vaccination(s) and 28 days after the vaccination.~        -  Prevaccine and postvaccine blood and nasal wash samples will be compared to determine~          volunteers immune responses.~        -  Research samples will be stored indefinitely and will be used strictly for laboratory~          experiments.~   "
181295|NCT01191840|"~     The purpose of this study is to accurately determine the length of appropriate drug treatment~     for staphylococcal blood stream infection. The study seeks to address important information~     about the management of staphylococcal blood stream infections.~   "
181296|NCT01191827|"~     This study aims to determine how clozapine treatment improves neuronal measures of sensory~     gating in subjects with schizophrenia.~   "
181297|NCT01191814|"~     Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr~     plastic stents. When compared to plastic stents, randomized trials have shown longer patency~     and fewer stent-related complications for CSEMS. The investigators hypothesize that placement~     of CSEMS would be a better treatment option for preoperative biliary decompression in~     patients with pancreatic cancer.~   "
181298|NCT01191801|"~     This study compared treatment groups of patients treated with vosaroxin and cytarabine versus~     patients treated with placebo and cytarabine.~   "
181299|NCT01191788|"~     The investigators will investigate whether group Cognitive Behavioral Therapy (CBT) for~     depression, with alcohol and other drug (AOD) treatment counselors leading the groups, is~     effective and cost effective in treating depression. If so, it could substantially increase~     access to appropriate mental health care. 360 clients with Beck Depression Inventory-II~     scores > 17 who are being treated in a single public sector AOD treatment organization will~     receive one of two conditions: (1) usual care residential AOD treatment (UC); (2) usual care~     AOD residential treatment plus a 16-session course of group CBT delivered by trained AOD~     counselors (CBT). Data will be analyzed using an intent-to-treat model. The investigators~     will collect data on the service-level costs and health effects associated with UC and CBT,~     and will calculate the incremental cost per unit of depression and AOD improvement, compared~     to UC.~   "
181300|NCT01191775|"~     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. The~     purpose of this research study is to evaluate the safety of the investigational drug PNT2258~     in patients with advance tumors and see how it acts in the body.~   "
181301|NCT01191762|"~     The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium~     reabsorption in the distal nephron and thereby necessitates supranormal [PTH]to maintain~     normocalcemia in chronic kidney disease. This study will examine the hypothesis with measures~     of phosphate homeostasis and calcium reabsorption. A double-blind trial of the intestinal~     phosphate binder sevelamer carbonate will be employed to examine whether reductions in~     phosphate influx alter distal nephron phosphate concentration and the [PTH] required for~     calcium reabsorption in the expected manner.~   "
181302|NCT01191749|"~     The goal of this clinical research study is to determine the effectiveness of alemtuzumab in~     patients with aplastic anemia, MDS, or T-Cell large granular lymphocytic leukemia. The safety~     of alemtuzumab will also be studied.~   "
181303|NCT01191736|"~     Bystander CPR improves survival from Out of Hospital Cardiac Arrest. This study examines the~     efficacy of ultra-brief video training for Hands-Only CPR. Subjects were randomized to one of~     four training conditions, then assessed for CPR skills retention.~   "
181304|NCT01191723|"~     Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered~     by Oral Inhalation) with Moxifloxacin and Placebo.~   "
181305|NCT01191710|"~     The aim is to explore whether the incidence of progesterone rise in the late follicular phase~     differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this has an~     impact on the probability of pregnancy achievement.~   "
181306|NCT01191697|"~     The purpose of this study is to determine the safety and effectiveness of a combination of~     chemotherapy, capecitabine and oxaliplatin, plus the antibodies bevacizumab and trastuzumab.~     Trastuzumab (also called Herceptin) is an antibody that attacks HER2 protein in tumor cells.~     Bevacizumab (also called Avastin) works by slowing or stopping the growth of cells in cancer~     tumors by decreasing the blood supply of the tumors. If blood supply is decreased, oxygen and~     nutrients that are needed for tumor growth are decreased. The chemotherapy used in this trial~     is called CAPOX, which is an abbreviation of capecitabine and oxaliplatin.~   "
181307|NCT01191684|"~     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective~     immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with colorectal, stomach, or pancreatic cancer.~   "
181308|NCT01191671|"~     The first years of life are considered essential to child development, as there is greater~     brain growth and formation of more neural connections. Therefore, the stimulation of children~     in various fields of development becomes relevant to the acquisition of knowledge and skills.~   "
181309|NCT01191658|"~     The circumference of a person's neck is a useful predictor of difficulty of insertion of a~     breathing tube.~   "
181312|NCT01191619|"~     The ProSeal laryngeal mask airway (PLMA) is one of the alternative methods for effective~     airway management. It is an advanced form of laryngeal mask airway(LMA) with a softer and~     larger cuff to improve sealing and a drain tube to permit venting of the stomach. However,~     the larger cuff is more difficult to save space for insertion in the mouth and is more likely~     to fold over. Particularly, a relatively large tongue, a floppy epiglottis, a cephalad and~     more anterior larynx and frequent presence of tonsillar hypertrophy may disturb PLMA~     insertion in pediatric patients. The manufacturer recommends inserting PLMA using digital~     manipulation or with an introducer, but these techniques have lower success rates compared to~     those of LMA insertion.~      McIvor blade is a tongue retractor with a thin and curved blade and a flat handle. It is used~     to secure the operating field by pressing tongue during tonsillectomy. The investigators~     hypothesized that McIvor blade would provide more space in the mouth for PLMA insertion, and~     therefore it could improve the PLMA insertion as well as reducing injuries to the pharyngeal~     wall. The investigators compared the success rate and the incidence of complications of the~     digital technique with those of McIvor blade-guided insertion by unskilled anesthesia~     residents.~   "
181313|NCT01191606|"~     The aim of this study is to determine the effects of pressure controlled ventilation during~     protective one lung ventilation on blood gases, airway pressures and hemodynamic variables~     compared with volume controlled ventilation.~   "
181314|NCT01191593|"~     The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at~     reducing pain and morphine consumption after revision knee arthroplasty.~   "
181315|NCT01191580|"~     The investigators propose a randomized clinical trial to compare the efficacy of~     Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive~     Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality~     of life among patients with breast cancer and major depressive disorder (MDD).~   "
181316|NCT01191567|"~     Wounds have long been a source of suffering for unfortunate victims and in recent years new~     complementary methods have been developed in areas where traditional wound treatment has been~     insufficient. Treating wounds with negative pressure, Vacuum assisted closure® [VAC], is a~     relatively new method of treatment and knowledge about its effect on patients is limited.~      Earlier studies haven't been able to answer the question about which groups of patients that~     are in most favour of the treatment and what impact the treatment has on the patient's~     quality of life.~      It is important with further research since an effective and mild wound treatment can~     decrease suffering and increase quality of life for the patient. Wound treatment that does~     not lead to an achieved treatment goal can lead to a risk for the patient and should be~     avoided.~      The project consists of 4 part studies: Study 1 and 2 are chart review studies of a~     consecutive series of patients treated with VAC at Södersjukhuset during a 3 year period. The~     patients are described on the basis of medical, surgical and demographical factors. Outcome~     is treatment results and risk factors for a treatment failure.~      Study 3 and 4 are clinical randomised studies with the aim of studying whether treatment with~     VAC provides a faster and more effective healing of acute and postoperative wounds, and in~     what way the treatment affect the quality of life and pain of the patients, compared to~     conventional treatment.~   "
181317|NCT01191554|"~     Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic~     acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and~     transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently~     multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown~     that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized~     study focus on TA in primary valve surgery. The aim of this prospective, double-blinded,~     randomized trial is to compare two dosing regimens of TA during primary valve surgery on~     perioperative blood loss and allogeneic blood transfusion.~   "
181318|NCT01191541|"~     Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low~     relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining~     ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding Ara-C~     in the chemotherapy of APL reduced treatment toxicity without increasing relapses. While the~     relapse rate for the children with white blood cell(WBC) counts greater than 10×109/L at~     presentation were higher than those WBC counts less than 10×109/L (31% and 3.5%,respectively)~     in the LPA96 and 99 trials. A recent adult randomized trial show that avoiding Ara-C leads to~     an increased risk of relapse in the APL patients with WBC counts less than 10×109/L. The role~     of the Ara-C remains controversial. And there are very limited data reported on children with~     APL so far.~   "
181319|NCT01191528|"~     To compare two ways to test breathing after surgery in acute care setting. One method tests~     oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is~     breathed out.~   "
181320|NCT01191515|"~     The purpose of this study is to evaluate the near and intermediate visual outcomes of~     patients who have undergone routine cataract surgery (removal of cloudy crystalline lens)~     with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a~     plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at~     least one eye.~   "
181321|NCT01191502|"~     The purpose of this study is to evaluate visual acuity in different lighting conditions~     (daylight and night time) and distances (distance, near and intermediate), and the~     independence of glasses, in patients who have had binocular implantation of the Tecnis~     Multifocal IOL or the Crystalens™ HD Accommodating IOL.~   "
181322|NCT01191489|"~     The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the~     reintubation rate. Post-extubation respiratory failure risk will be stratified (as the~     randomization). In high risk patients high flow conditioned oxygen therapy will be compared~     with with not conditioned non-invasive mechanical ventilation. In low risk patients~     comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.~   "
181323|NCT01191476|"~     This study is being performed to compare the cost of anesthetic techniques with sevoflurane~     (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion [TCI])~     versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing~     elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.~   "
181324|NCT01191463|"~     Iron deficiency is estimated to affect about one fifth of the world's population, and women~     and children are among the most severely affected. Evidence is mounting that iron deficiency~     anemia adversely affects brain development with measurable effects on children's behavior,~     motor development and cognition. In Hisar district of Haryana state, north- India, 58% of~     school age children (6-10 years) are anemic, 49 % are iron deficient whereas 40 % have been~     found to be anemic due to iron deficiency. Iron bioavailability calculated using algorithms~     in regional diets ranged from 3.2 to 4.6 percent. Mungbean (Vigna radiata L.) is the third~     most important legume crop of India. It is a high potential legume crop with 4-8 mg of iron~     and known as a nutritious and healthy legume. Ascorbic acid is a potent enhancer of iron~     absorption in humans which can counteract the inhibitory effect of phytic acid and~     polyphenols. Guava is a popular and easily available fruit for this community having 200- 300~     mg/100g of ascorbic acid. We will conduct a randomised controlled trial in school age~     children (6-10 years) in Haryana state of India, to determine the efficacy of local vitamin-C~     rich fruit guava with mungbean based meal on iron status of rural Indian children.~      Objective: To assess the effect of mungbean based test meal on iron status (as body iron~     stores, defined and calculated by the ratio of serum ferritin and serum transferrin receptor)~     of school age children (6-10 years) with and without the consumption of guava, a vitamin C~     rich fruit, in a school feeding program for seven months.~      Study population: Three hundred school children aged between 6-10 years will be recruited~     from two government school of Mangali village situated in Hisar district of Haryana state.~      Study design: This intervention study will be carried out in a randomized controlled design.~     Main study parameters/endpoints: Primary outcome will be the measurement of body iron stores~     (mg/kg of body weight) based on the ratio of serum transferrin receptor to serum ferritin.~   "
181325|NCT01191450|"~     The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg +~     amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial~     hypertension.~   "
181326|NCT01191424|"~     The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of~     Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the~     NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP,~     Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a~     free combination of BDP DPI plus FF DPI licensed products after a morning dose administration~     of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic~     patients.~   "
181327|NCT01191411|"~     Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can~     prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations~     such as those with limited or no health insurance. This striking public health challenge~     demands urgent implementation of evidence-based strategies to reduce avoidable CRC death.~      Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to~     complete CRC screening may result in increased rates of screening completion. However, this~     approach has not been tested extensively in vulnerable populations, such as the~     under/uninsured, and minority populations often cared for by safety-net health systems.~     Further, it is unclear whether patients are more likely to participate in one CRC screening~     test versus another. Knowing this is important to designing programs for increasing~     screening. For example, the planning and resources required for a screening program with~     colonoscopy--which is a sensitive but invasive and expensive test--are very different from a~     program with that uses stool testing to detect microscopic blood such as an immunochemical~     stool blood test--which is a less sensitive, but non-invasive and cheap test.~      Also, it is possible designing a program with a less sensitive, but more acceptable test~     could prevent more CRC death if participation in screening is test specific. For example, if~     many more patients participate in an immunochemical stool blood test based program than a~     colonoscopy based program, even though the immunochemical stool blood test is less sensitive,~     the program may save more lives because more patients are reached.~      The aims of this trial are to:~      Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders,~     and systematic clinical follow up) to uninsured, unscreened patients cared for by the~     safety-net health system serving Tarrant County, Texas. Patients will be invited to either:~        1. Complete a free home-based, non-invasive immunochemical stool blood test~        2. Complete a free colonoscopy~      Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program~     costs.~      The primary outcome is screening completion.~   "
181328|NCT01191398|"~     The purpose of this study is to determine if the antisialagogues (anti-salivary agents),~     Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients~     with Ketamine for procedural sedation in the emergency department or abscess clinic. The~     investigators will measure salivary flow rate by collecting oral secretions by oral~     suctioning over a 30 minute time period starting with the administration of Ketamine. The~     investigators hypothesize that patients who receive either atropine or glycopyrrolate will~     have fewer oral secretions than patients who receive placebo.~   "
181329|NCT01191385|"~     This study is an international prospective, open-label, multi-center, non-interventional~     study. The protocol will allow enrollment of all patients with diagnosis of HCC in whom a~     decision to treat with sorafenib has not been made at time of study enrollment. All patients~     will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the~     study. Detailed information concerning the past medical/surgical history, performance status,~     methods of diagnosis and staging, etc. of patients with HCC will be collected, and practice~     patterns of the physicians involved in the care of patients with HCC under real-life~     conditions will be evaluated.~   "
181330|NCT01191372|"~     The purpose of this study is to examine the safety, tolerability and the way the body handles~     various single and multiple doses of ARC19499 in patients with hemophilia.~   "
181331|NCT01191359|"~     Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS~     Birch in regard to pharmacodynamic efficacy and tolerability.~   "
181332|NCT01191346|"~     The purpose of this research study is to see if a higher strength MRI procedure provides~     better images to use in planning radiation treatments for patients with brain tumors in the~     future.~   "
181333|NCT01191333|"~     The purpose of this multi-site trial is to determine if repetitive Transcranial Magnetic~     Stimulation (rTMS) helps people with depression who have not been helped by medications or~     who have not been helped enough by medications.~   "
181334|NCT01191320|"~     The purpose of this study is to determine the effect the investigative drug has on glycemic~     control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism~   "
181335|NCT01191307|"~     The ASK CHILDREN study is intended to aid in future development of various neurologic devices~     (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information obtained to~     identify more efficient strategies in the evaluation and review of neuroprostheses regulated~     by the Agency.~   "
181336|NCT01191294|"~     The investigators will design a curriculum for visual screening for melanoma and skin biopsy~     procedure, based on the mastery learning model, using simulators and web-based didactic~     instruction for medical students and internal medicine residents. This requires having a skin~     simulation model that presents a range of lesions from benign nevus to atypical nevus to~     melanoma in a distribution and density that mimics the clinical findings of those with 2 skin~     tones: fair-skin non- Hispanic white and Hispanic.~   "
181353|NCT01191073|"~     In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM)~     fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared~     with a traditional fabricated RPD for 50 consecutive patients.~      During 5 years the patients are in a follow-up program in order to judge long-term stability,~     loss of retention, fractures, … of both groups of dentures.~   "
181337|NCT01191281|"~     The purpose of this three-year study is to develop, implement, and pilot test a culturally~     appropriate, multi-component nutrition intervention for people living with HIV and food~     insecurity in Honduras, which is among the Latin America nations with the highest HIV~     prevalence rates. The investigators specific aims are to:~        1. Explore the relationships between food security, nutrition, and HIV treatment access,~          utilization, and adherence, and examine key mediators and moderators of these~          relationships.~        2. Develop a multi-component nutrition intervention to address food insecurity among~          Honduran HIV+ individuals and their families.~        3. Evaluate the preliminary effectiveness of the intervention on (1) food security and~          nutritional status; (2) HIV care retention (clinic attendance), uptake of ART when~          recommended, and ART adherence; and (3) clinical outcomes (CD4 count, ART side effects,~          and opportunistic infections).~        4. Examine key mediators and moderators of the intervention effects from among~          characteristics of the patient, household, and contextual setting.~   "
181338|NCT01191268|"~     The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to~     Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in~     participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.~   "
181339|NCT01191255|"~     This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD~     dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.~   "
181340|NCT01191242|"~     Methadone has been an effective and inexpensive therapy in the management of chronic pain and~     opioid dependence. However it has been associated with sudden, unexpected deaths. Two~     mechanisms have been suggested, increased drug concentration in the blood, and a change in~     the heart rhythm. This study will look at blood samples for drug levels and genetic~     components and EKG's (a noninvasive test which reveals heart rhythm). There will be no~     intervention.~   "
181341|NCT01191229|"~     The study is being conducted to collect information about visual outcomes and participant~     satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared~     with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S.~     Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual~     correction of aphakia (replacing a removed lens in the eye) in adults.~   "
181342|NCT01191216|"~     This phase I trial is studying the side effects and best dose of giving 1-methyl-d-tryptophan~     and docetaxel together in treating patients with metastatic solid tumors. Biological~     therapies, such as 1-methyl-d-tryptophan, may stop the growth of tumor cells by stimulating~     the immune system and by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving 1-methyl-d-tryptophan~     with chemotherapy may kill more tumor cells.~   "
181343|NCT01191203|"~     The IUD is an extremely effective method of contraception yet few women use it worldwide.~     Considered safe to use in HIV+ women, few studies have evaluated its use among those using~     antiretroviral therapy. The only prior randomized trial looking at the IUD compared to~     hormonal contraception noted a high rate of IUD discontinuations. Understanding IUD~     acceptability and continuation is critical to improve utilization.~        -  Objective 1: Determine WHO medical eligibility and the willingness for IUD placement~        -  Objective 2: Compare method-related side effects and adverse events~        -  Objective 3: Assess the 1-year acceptability and continuation rates~      Methods: To address our objectives the investigators have designed a two Phase Study:~        -  A cross-sectional screening to evaluate contraceptive medical eligibility and~          desirability~        -  A randomized controlled trial that will compare acceptability and adherence to DMPA~          compared to the Copper IUD: enrolling 200 women stable on antiretroviral therapy to~          follow for 1 year~   "
181344|NCT01191190|"~     Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be~     eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4~     week cycles. The primary endpoint is to determine the complete response (CR) to therapy and~     the secondary endpoints will assess the safety and tolerability of the regimen, the impact of~     the treatment on progression free, treatment free, overall survival, and pharmacokinetics of~     ofatumumab. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial~     prophylaxis.~   "
181345|NCT01191177|"~     The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in~     normalizing liver function in patients who have parenteral nutrition associated liver~     disease. The investigators believe that patients who take oral fish oil will normalize liver~     function faster than those who do not~   "
181346|NCT01191164|"~     Background: Recent single arm studies have suggested that partial breast irradiation (PBI),~     delivered in a relatively short overall treatment time of a few days, may be an effective~     alternative to adjuvant whole breast irradiation (WBI) delivered over a number of weeks.~     Several PBI modalities and techniques have been investigated, including interstitial~     brachytherapy and external beam radiation therapy, most often given over the course of one~     week of twice daily outpatient treatments. One randomized study has shown equivalency between~     WBI and PBI using brachytherapy. There are currently three large phase-III randomized studies~     comparing PBI to WBI.~      Permanent Breast Seed Implant (PBSI) is the newest PBI technique which has been piloted at~     the Odette Cancer Centre (OCC) in Toronto. The main advantage of this technique is that it~     requires only one out-patient procedure. The treatment is administered by implanting~     radioactive Palladium (103Pd) seeds into the tumor bed region in a 1 to ½ hour outpatient~     procedure, after which the patient is discharged home to resume her normal living activities.~     This PBI procedure was shown to be well tolerated with minimal acute toxicity. Estimated~     partner radiation exposure was well within internationally acceptable levels. Subjects with a~     seroma >2cm were, however, excluded.~      Hypothesis: PBSI is a feasible, safe, and acceptable treatment option for the subject and her~     partner in the context of medical practice and resources in BC.~      Objectives: In subjects who have undergone breast conserving surgery for early breast cancer:~        1. To determine the technical feasibility of PBSI in BC~        2. To measure the subject's partner in terms of radiation protection~        3. To evaluate acceptability of PBSI by the subject~        4. To assess resource requirements for PBSI~      Method: This is a single arm feasibility study. Five women who had undergone breast~     conserving surgery for breast cancer with low risk of local recurrence will be accrued. This~     study will adhere to a detailed written protocol for radiation measurements and protection.~      Subjects will undergo PBSI within 4-14 weeks from last breast surgery. The procedure will be~     performed in an outpatient setting, under conscious sedation and local anesthesia, by a team~     with a wide brachytherapy experience. The technique used in this feasibility study will be~     based on the OCC technique. It is intended that two oncologists and one physicist will spend~     2-3 days at the OCC to acquire detailed and firsthand knowledge of the technique as~     implemented at that centre.~      The OCC technique is US-based; in this study, however, an additional CT-assisted planning~     component will be investigated building on the experience of the VIC team which conducted the~     BC Cancer Agency Vancouver Island Centre's pilot study of CT-based multi-catheter~     brachytherapy PBI.~      Systemic therapy will be according to BCCA guidelines; however, subjects requiring adjuvant~     chemotherapy will be excluded from this study. Subjects will be followed prospectively for 5~     years for evaluation of toxicity, QOL and cosmesis. Disease status will be recorded.~      Relevance: Completing adjuvant breast irradiation with a single out-patient treatment could~     significantly improve QOL and convenience for patients choosing breast conserving therapy.~     Confirming the technical feasibility and safety of PBSI is needed before progressing to~     larger prospective evaluation of this novel adjuvant radiation therapy technique as a viable~     treatment option for women in British Columbia.~   "
181347|NCT01191151|"~     The purpose of this study is to establish an international, web based clinical registry to~     collect baseline characteristics of patients undergoing orthopaedic, sports medicine,~     arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness~     associated with the surgical procedures and nonoperative treatments.~   "
181348|NCT01191138|"~     Patients undergoing whipples pancreaticoduodenectomy tend to develop delayed gastric~     emptying.~      The study compares two types of anastamosis of stomach to jejunum (supracolic and infracolic)~     and compares whether it influences the gastric emptying.~      The clinical evidence of delayed gastric emptying is correlated with objective evidence of~     liquid and solid emptying by radionuclide study.~      The study also tries to evaluate whether pancreatic leak correlates with delayed gastric~     emptying~   "
181349|NCT01191125|"~     To evaluate the effect of an experimental oral nutritional supplement containing AN777~     compared to another oral nutritional supplement in a malnourished, elderly population.~   "
181350|NCT01191112|"~     The objective of this study is to determine the safe use and tolerance of a peptide-based~     formula in children with gastrointestinal dysfunction and/or feeding intolerance.~   "
181351|NCT01191099|"~     A single-center cohort study to identify uni- and multivariate associations between marker~     gene expression and clinico-pathological parameters for the detection of robust and novel~     prognostic tools in prostate cancer~   "
181352|NCT01191086|"~     The purpose of this study is to examine the safety of USL255 as adjunctive therapy in~     patients with refractory partial onset-seizures.~   "
181354|NCT01191060|"~     Objective of this study is to determine if, in the era of novel drugs, high dose therapy~     (HDT) is still necessary in the initial management of multiple myeloma in younger patients.~     HDT as compared to conventional dose treatment would be considered superior if it~     significantly prolongs Progression-free survival (by at least 9 months).~   "
181355|NCT01191034|"~     Human cancers express tumor antigens that can be targeted by cytolytic T lymphocytes (CTL).~     These antigens consist of a small peptide, derived from endogenous proteins, that is~     presented at the cancer cell's surface by an HLA class I molecule. Such antigenic peptides,~     including MAGE-3.A1 and NA17.A2, have been tested in experimental therapeutic vaccines to~     elicit CTL responses in cancer patients, mainly with metastatic melanoma. Up to now, only~     rare tumor responses have been observed.~      Tumor resistance to CTL killing is the most likely explanation for the poor effectiveness of~     cancer vaccines. This resistance is probably acquired by the tumor during its development and~     selected by its repetitive challenge with spontaneous anti-tumoral immune responses. The~     precise molecular mechanisms of tumor resistance remain unknown. The observation that~     tumor-infiltrating lymphocytes (TIL) purified from melanoma metastases can recognize and kill~     autologous tumor cells in vitro, whilst they seem unable to control tumor growth in vivo,~     suggests that this resistance is hosted by the tumor environment, rather than being the~     result of a generalized immune suppression.~      The investigators have developed a murine model of cutaneous graft rejection that mimics the~     situation in melanoma. Female CBA mice do not reject syngeneic male skin grafts, even though~     they mount a spontaneous CTL response against H-Y, a male specific minor histocompatibility~     antigen, following grafting. The investigators have tested various experimental procedures~     aimed at inducing effective graft rejection in these mice. This was obtained with a~     combination of IFN-α, IL-2, GM-CSF, each administered separately under the skin graft,~     associated with topical applications of imiquimod. All these agents are available as~     registered drugs. Based on this murine model of cutaneous allograft rejection, the~     investigators postulate that local immunomodulation with this combination can trigger an~     effective tumor rejection process, and induce a more efficient and long-lasting anti-tumoral~     immune response following peptide vaccination.~   "
181356|NCT01191021|"~     This trial investigates the relationship between concentrations of the anesthetic drug~     propofol in exhaled breath, blood and drug effect in volunteers undergoing general~     anesthesia. The main goal of this study is to develop a pharmacokinetic - and dynamic model~     for propofol in exhaled breath.~   "
181357|NCT01191008|"~     The objective of this Investigation is to evaluate the safety and efficacy of long-term~     treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse~     drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey~     period, and whether an additional treatment outcome investigation and/or a post-marketing~     clinical study is required in the future will be determined.~   "
181358|NCT01190995|"~     Procedural pain in neonates is recently acknowledged entity and many studies on the use of~     pharmacological as well as non pharmacological interventions for alleviation of this pain~     have been done. Of these, sucrose with or without non nutritive sucking has been the most~     widely studied and accepted form of pain relief. Its analgesic effect is thought to be~     mediated by endogenous opioid pathways activated by sweet taste (orogustatory effect).~      Although, guidelines based on systematic reviews and meta-analysis for pain management~     recommend the use of sucrose solutions for pain relief during procedures, the use of repeated~     doses of sucrose with preterm neonates requires further investigation.~      Pain may have profound consequences for preterm neonates during a critical time of brain~     development. Data derived from animal models suggests that repeated painful stimuli may~     result in structural and functional reorganization of the nervous system and alteration in~     future pain response. Early pain experience during this critical period in development are~     thought to have immediate and long term consequences that could influence physiological,~     behavioral and developmental outcomes. Early repetitive procedural pain related stress in~     very preterm neonates is associated with poorer neurobehaviour in first 2 years of life.1~     This study aims to assess the effect of repeated painful stimuli on short term neurobehaviour~     of preterm infants and the efficacy of repeated doses of sucrose used for pain relief.~   "
181359|NCT01190982|"~     LEP-ETU is a novel, proprietary delivery system of paclitaxel developed by NeoPharm, Inc.~     Paclitaxel (currently marketed as Taxol) is an anti-microtubular network agent and is active~     in a broad spectrum of malignancies. Paclitaxel has poor solubility. In order to enhance the~     solubility, this drug is formulated with polyoxyethylated castor oil, which leading to~     infusion-related hypersensitivity reactions. The NeoPharm LEP-ETU is formulated with a~     mixture of well characterized, synthetic phospholipids and cholesterol. This design~     eliminates the need for the oil. The LEP-ETU formulation has improved safety profile that is~     necessary for administering higher doses than would commonly be used with Taxol. The clinical~     evidence obtained from the NeoPharm Phase I study shows LEP-ETU is better tolerated than~     Taxol, as indicated by a higher maximum-tolerated dose (MTD). The current Phase II study is~     designed to accomplish the following objectives:~        1. Assess the Overall Response Rate (ORR) of patients with metastatic breast cancer after~          administered over 90 minutes at the dose of 275 mg/m2 LEP-ETU~        2. To evaluate the Progression-Free Survival (PFS)~        3. To evaluate the safety of LEP-ETU at 275 mg/m2 level, in particular peripheral~          neuropathy~        4. To evaluate the Overall Survival (OS)~   "
181360|NCT01190969|"~     The purpose of this study is to determine whether short-term use of oral nutritional~     supplements as part of the diet improves nutritional and functional status of~     post-hospitalization malnourished elderly.~   "
181361|NCT01190943|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers~     related to cancer. DNA analysis of tumor tissue may also help doctors predict how well~     patients will respond to treatment.~      PURPOSE: This research study is studying DNA biomarkers in tissue samples from patients with~     osteosarcoma.~   "
181362|NCT01190930|"~     This partially randomized phase III trial studies different combinations of risk-adapted~     chemotherapy regimens and their side effects and comparing how well they work in treating~     younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage~     lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized).~     Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving more than one drug (combination chemotherapy), giving the drugs in different doses,~     and giving the drugs in different combinations may kill more cancer cells.~   "
181363|NCT01190917|"~     The purpose of this study is to compare two different treatment approaches to social skills~     groups for high-functioning children with Autism Spectrum Disorder (ASD). This project will~     examine changes in both behavior and the brain following treatment.~   "
181364|NCT01190904|"~     The purpose of this study is to find out if androgen deficiency (low levels of testosterone,~     a male hormone produced by the sex glands) and erectile dysfunction (sexual dysfunction) will~     predict over time the development of a heart attack, stroke, or death in men with Diabetes~     Mellitus who have angiographically proven coronary artery disease (CAD) (≥50%) with or~     without percutaneous coronary intervention (PCI). A substudy aims to show the different~     factors and processes that may show a relationship between sexual function and levels of~     androgen in the body to heart disease.~   "
181365|NCT01190891|"~     The purpose of this study is to evaluate and compare the short and long-term effectiveness of~     two common interventions, manual physical therapy versus corticosteroid injection, for the~     treatment of shoulder impingement syndrome.~   "
181366|NCT01190878|"~     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in~     topical administration of differing dosing regimens of ISV-303 compared to vehicle and~     Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.~   "
181367|NCT01190865|"~     The goal for this study is to examine the persistence of growth~     arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product~     HP802-247 to the surface of acute excisional wounds in health female volunteers, as measured~     using Y-STR for detection of Y-chromosome.~   "
181368|NCT01190852|"~     The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative~     bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU~     combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE~     alone; REF).~      The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when~     administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product~     Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic~     parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.~   "
181369|NCT01190839|"~     REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in~     an experiment to see if it may be useful in preventing relapse of Crohn's disease after~     surgical resection. This study will compare the effects (both good and bad) of REMICADE~     (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active~     ingredients.~   "
181370|NCT01190826|"~     The purpose of this study is to evaluate the safety, tolerability and clinical activity of~     ASM-024 in stable moderate asthma.~   "
181371|NCT01190813|"~     The purpose of this study is to evaluate the efficacy and safety of oral levodopa and~     patching versus oral placebo and patching as treatment for residual amblyopia in children 7~     to <13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.~   "
181372|NCT01190800|"~     The purpose of this study is to assess decision-making capacity in persons with Alzheimer's~     disease. First, our goal is to validate four French capacity assessment tools for persons~     with Alzheimer's Disease : a French version of the Competency Assessment Tool for Consent to~     Treatment and of the Competency Assessment Tool for Voting, two questionnaires assessing the~     capacity to appoint a proxy either to consent to treatment or to vote. Second, once~     validated, we plan these questionnaires to study decision-making abilities and their~     determinants in persons with Alzheimer's disease and control subjects.~   "
181373|NCT01190787|"~     This protocol is a single-arm, three-cohort, phase II multicenter study designed to assess~     the safety and the efficacy of three all-oral combinations: Velcade with continuous low-dose~     melphalan and prednisone (VMP) or with continuous low-dose cyclophosphamide and prednisone~     (VCP) or Velcade with low-dose prednisone could be effective and well tolerated (VP).~   "
181374|NCT01190774|"~     Dental anxiety is a significant barrier to the acceptance of regular dental care, and has~     many negative consequences. A study by Dailey et al. (2002) found that providing the dentist~     with information of the high level of a patient's dental anxiety prior to treatment using the~     Modified Dental Anxiety Scale (MDAS, Humphris et al., 1995), lead to a significant reduction~     in state anxiety from pre- to post- dental consultation compared to a control group. The~     current study aimed to replicate the study by Dailey et al. (2002), and to further explore~     whether the reduction in state anxiety associated with the MDAS could be explained by a~     change in dentist behaviour on receiving it, or a change in patient expectancy about the~     treatment session, or both.~      The design was a randomised control trial involving three groups, which aimed to manipulate~     possible changes in dentist behaviour and patient expectancy. In Group 1, the MDAS was left~     at reception, as expected by the patient. In Group 2, the dentist received the MDAS, although~     the patient did not expect this. In Group 3 the dentist received the MDAS and the patient did~     expect this. The sample (N=182) was taken from two dental access centres, and included~     participants obtaining a score of 19 or above, or 5 on any one item of the MDAS. Pre- and~     post-dental consultation measures of state anxiety were taken using the six-item short-form~     of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI-S, Marteau &~     Bekker, 1992).~   "
181375|NCT01190761|"~     The objective of this study was to compare the rate and extent of absorption of Purepac, a~     subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P.,~     U.S.A. (Reminyl),galantamine, administered as a 1 x 4 mg tablet, under fed conditions.~   "
181376|NCT01190748|"~     The objective of this study was to compare the rate and extent of absorption of Purepac, a~     subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P.,~     U.S.A. (Reminyl),galantamine, administered as a 1 x 4 mg tablet, under fasting conditions.~   "
181377|NCT01190735|"~     Numerous epidemiological studies have linked lifelong use of caffeine to a lower risk of~     Parkinson's disease (PD) - prospective studies have estimated that non-coffee drinkers have~     an approximately 1.7-2.5 fold increased risk of developing PD compared to coffee drinkers.~     This is an extremely important finding which deserves further more in depth investigations.~      The exact pathophysiological mechanism remains elusive, but multiple hypotheses do exist:~     Caffeine antagonizes adenosine receptors directly yielding an improvement on motor systems~     and even on Levodopa serum concentrations (when on therapy). An additional explanation is~     that adenosine antagonism has neuroprotective properties by acting locally on basal ganglia~     circuits and the substantia nigra.~      The current study aims to identify the optimal caffeine dose with maximal motor benefit and~     the least amount of undesirable adverse effects.~   "
181378|NCT01190722|"~     The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a~     better patients assessed overall satisfaction when used for pain management after elective~     hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs~     (NSAIDs).~   "
181379|NCT01190709|"~     The purpose of this study is to determine which surgical approach is better for treatment of~     tibial shaft fracture~   "
181380|NCT01190696|"~     The purpose of this study is to determine which method is better for treatment of femoral~     fracture in children in outcomes.~   "
181381|NCT01190683|"~     Vitamin D deficiency is widely prevalent in India. Serum 25(OH)D levels are <20 ng /ml in up~     to 90% of them. Recently, in a randomized control trial, investigators have shown that dual~     cholecalciferol and calcium supplementation lead to significant improvement in hand grip~     strength and distance covered during six minutes walk test. Present study is being taken to~     further understand the functional significance of 25(OH)D in terms of its effect on Skeletal~     muscle strength including surface electromyography (EMG) in a larger cohort involving~     approximately 200 subjects. The impact of calcium and vitamin D supplementation would be~     assessed by supplementing them alone and in combination. Besides, the investigators would~     also assess impact of above supplementation on Th1/Th2 cytokines expression in the peripheral~     mononuclear cells.~   "
181382|NCT01190670|"~     The objective of the study is to characterize the effect of multiple doses of ASP015K on the~     pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.~   "
181383|NCT01190657|"~     This is a self-controlled, open, multiple-center clinical trial.~   "
181384|NCT01190644|"~     What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by~     dosing with Sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has~     determined that all of these goals could be obtained by an intense 10 patient, Sotatercept~     (ACE-011) pharmacodynamic study, completed by two well known experts in the red cell~     production field.~   "
181385|NCT01190631|"~     The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL~     implantation, and to determine if an association exists between TSA, postoperative high order~     aberrations (HOA), and functional vision following IOL implantation in patients grouped by~     pre-operative corneal spherical aberration (CSA).~   "
181386|NCT01190618|"~     The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair~     with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair~     with Prolift. .~   "
181387|NCT01190605|"~     Women with HIV infection in Mississippi who are pregnant or who have had their baby in the~     past year can agree to fill out a questionnaire about what helps or hurts return to care for~     HIV infection after having a baby. The combined results should show the most common things~     that keep women from getting care for HIV infection after having a baby. This will help~     design another study in order to help more women get into care for HIV infection after having~     a baby.~   "
181388|NCT01190592|"~     The investigators primary objective is to evaluate the effect of a 6 month (3 days/wk)~     supervised, progressive RT program with increased daily milk intake in untrained adolescents~     on measures of body composition and cardiovascular risk factors. The investigators~     hypothesize that milk supplementation will produce significantly greater favorable changes in~     all body composition measures compared with RT + carbohydrate and control.~   "
181389|NCT01190579|"~     The trial will investigate the accuracy of Dual Source CT coronary angiography to detect~     coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an~     intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will~     be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT~     will allow the detection of vessels with at least one coronary artery stenosis with a~     sensitivity of more than 90%.~   "
181390|NCT01190566|"~     The purpose of this study is:~      To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging~     in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced~     breast cancer patients.~      To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI,~     dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response~     to neoadjuvant chemotherapy of locally advanced breast cancer patients.~      To compare the performances of dynamic contrast-enhanced MRI using parametric response map~     analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early~     prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer~     patients~   "
181391|NCT01190553|"~     This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with~     PARKINSON'S Disease who are not well balanced with medical treatment.~   "
181392|NCT01190540|"~     This evaluation aim is to investigate a cost-effective way to build capacity for the care and~     prevention of infectious diseases among mid-level practitioners (MLP) in sub-Saharan Africa.~     Classroom based training continues to be the dominant form of training, despite evidence that~     suggests that on-site support (OSS) is more beneficial. Definitive evidence that on-site~     support is the most effective way to deliver the required outputs and related outcomes is~     still lacking. IDCAP will provide two interventions that integrate training in TB, HIV/AIDS~     and malaria as well as other infectious diseases, and the effects will be studied: 1)~     Integrated Management of Infectious Disease (IMID) training program for individual MLP, and~     2) On-site support (OSS) for team of health professionals. This study employs a mixed design~     with pre/post and cluster randomized trial components. Interventions are at the level of the~     individual participant for IMID and at the level of the site (health facility) for OSS. All~     participants attend a 3-week course, followed by two 1-week booster courses over a six month~     period. After the 3-week course, a randomized arm of half the sampled facilities also~     received OSS every month for 9 months and bi-monthly for 6 additional months.~   "
181408|NCT01190332|"~     One of the new methods for management of common bile duct stones is intraoperative endoscopic~     sphincterotomy. It can be performed by many techniques. In the study the investigators~     compare two methods to find out the best technique for intraoperative endoscopic~     sphincterotomy.~   "
181409|NCT01190319|"~     The specific aim of the study is to determine whether a freeze dried powder provided by the~     California Strawberries Commission, can reduce blood pressure in patients with~     pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).~   "
181393|NCT01190527|"~     Successful treatment of non-small cell lung cancer with radiation therapy requires that the~     physicians determine exactly where the tumor is in your body, and protect your normal tissue.~     This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission~     Tomography (FDG-PET) before treatment, and then again during treatment to see if the~     procedure helps predict how well the treatment works for your cancer and how well your lung~     functions during treatment. FDG-PET is a modern technology that uses small amounts of a~     radioactive glucose (FDG) to make images of your whole body and areas of active cancer. A~     Computerized Tomography (CT) will also be performed along with both of these procedures to~     help the researchers see clearly where your cancer or your healthy lung is located. The study~     will help the investigator determine whether an adaptive plan that is applied based on repeat~     PET-CT imaging during the course of radiation therapy (during RT), can show if there is an~     improvement in treatment outcome compared to those treated with standard radiation therapy.~     This adaptive plan may allow your doctor to escalate the dose per treatment and the total~     dose of your treatment based on the risk of damage to your healthy lung tissue. While~     increasing the radiation dose, but limiting the toxicity to normal lung tissue, the~     researchers hope to improve your tumor control.~   "
181394|NCT01190514|"~     To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of~     DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.~      To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after~     administration of 50 mg SR formulation of DVS.~   "
181395|NCT01190501|"~     Our main objective is to assess whether aortic stiffness is a predictor of blood pressure~     response after surgery in patients with an aldosterone producing adenoma or a unilateral~     adrenal hyperplasia.~   "
181396|NCT01190488|"~     The investigators propose an evaluation of an end of life patient decision aid (EOL-PtDA)~     developed by the Foundation for Informed Medical Decision Making using the RE-AIM (Reach~     Effectiveness, Adoption, Implementation, and Maintenance) framework. To evaluate the Reach~     and Effectiveness, the investigators propose a pilot randomized clinical trial of the~     EOL-PtDA among patients on the inpatient palliative care service at University Hospital in~     Colorado. To evaluate barriers and facilitators of Adoption, Implementation, and Maintenance~     of the EOL-PtDA, we propose focus groups of non-palliative care physicians as we perceive~     these physicians to be the largest barrier to ultimate adoption of the EOL-PtDA. Additionally~     we propose a focus group of the palliative care physicians who participated in the~     implementation of this decision guide study to evaluate the feasibility of conducting a~     randomized control trial within a pall. care service and to evaluate the acceptability of~     this decision aid as it was implemented. The investigators also propose to conduct focus~     groups of normal, healthy clinic patients to determine the acceptability among that~     population. The End-of-Life decision aid is different from other decision aids. From the~     vantage point of decision quality, a major difference is that its primary focus is on helping~     patients clarify their values rather than gain knowledge. The results from this study will~     provide critical preliminary data to inform a randomized clinical trial and/or widespread~     implementation of the EOL-PtDA.~      Specific Aims/Research question(s):Aim 1: To determine the Reach and Effectiveness of an~     end-of-life patient decision aid by conducting a pilot randomized clinical trial in an~     inpatient palliative care service. Aim 2: To determine physicians' attitudes towards the~     end-of-life patient decision aid and to gain insights into potential barriers and~     facilitators to Adoption, Implementation, and Maintenance by conducting a qualitative study~     of non-palliative care, and separately, palliative care physicians. Aim 3: To determine~     healthy clinic patients' attitudes towards the end-of-life patient decision aid and to gain~     insight into its Reach and Effectiveness.~   "
181397|NCT01190475|"~     This study will assess the safety and tolerability of BGS649 in women with moderate to severe~     endometriosis.~   "
181398|NCT01190462|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Simvastatin may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Simvastatin may help~     cetuximab work better by making tumor cells more sensitive to cetuximab. Giving cetuximab~     together with simvastatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying giving cetuximab together with simvastatin in~     treating patients with advanced or metastatic colorectal cancer.~   "
181399|NCT01190449|"~     RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them.~      PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in~     treating patients with previously untreated stage II, stage III, or stage IV follicular~     non-Hodgkin lymphoma.~   "
181400|NCT01190436|"~     The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm~     study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day~     bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on~     therapy.~   "
181401|NCT01190423|"~     Temple University is conducting a National Institute of Health funded research study designed~     to develop and refine a family-based treatment manual for young adults with Anorexia Nervosa~     as well as assess the feasibility of this out-patient psychotherapy.~   "
181402|NCT01190410|"~     The purpose of this study is to evaluate the long-term safety and tolerability of~     certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely~     active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK),~     and immunogenicity of CZP treatment in children and adolescents with moderately to severely~     active Crohn's disease.~   "
181403|NCT01190397|"~     The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in~     the eyelids~      Phase I, prospective, comparative study, investigator masked , monocentric~      Objectives are To assess and compare the warming and moisture of Blephasteam® device versus~     the warming and moisture of warm and moist compresses.~      To assess and compare safety on the ocular surface after 10 minutes of Blephasteam®~     application versus after 10 minutes of warm and moist compresses application~   "
181404|NCT01190384|"~     Determine whether eating beans with a high fat meal will reduce the inflammatory response in~     people with the metabolic syndrome and increase feelings of satiety.~   "
181405|NCT01190371|"~     The purpose of this study is to determine whether P. falciparum infections in Kilifi District~     have developed tolerance to the artemisinin class of drugs.~   "
181406|NCT01190358|"~     The purpose of this study is to determine whether taking grape seed extract prior to eating a~     high fat meal will reduce the inflammatory response in people with the metabolic syndrome.~   "
181407|NCT01190345|"~     The purpose of this study is to evaluate anti-cancer stem cell (CSC) activity (measured by~     the amount of Aldehyde dehydrogenase 1/ALDH1+ cells before and after treatment) of~     pre-operative bevacizumab in combination with conventional chemotherapy in breast cancer~     receiving neo-adjuvant treatment, compared to a control arm receiving chemotherapy alone.~   "
181410|NCT01190306|"~     The purpose of this research study is to test the safety, tolerability, and effectiveness of~     corneal collagen cross-linking (CXL), when used to treat keratoconus.~   "
181411|NCT01190293|"~     The purpose of the study aims is to help determine whether it is safe to change directly from~     efavirenz to maraviroc in patients who are stable on an efavirenz-containing regimen. The~     pharmacokinetics (drug levels) of efavirenz and maraviroc when efavirenz is stopped and~     maraviroc is started will be assessed.~      Both the study patients and the study team will know which treatment is being taken at all~     times in the study.~   "
181412|NCT01190280|"~     The aim of the study is to identify patients with gallstone disease that should be operated~     and those that may potentially be observed. This selection was based on symptoms and clinical~     presentation. The consequences that may arise for the patient if observation is chosen~     compared with outcome after cholecystectomy has been markers of outcome.~   "
181413|NCT01190267|"~     This study is designed to evaluate whether asenapine, which is approved by the United States~     Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is~     generally safe and well tolerated in adolescents with schizophrenia. This is an extension of~     base study P05896 (NCT01190254), which means participants must have completed participation~     in the 8-week base study in order to qualify for this extension study P05897. Participants in~     this extension study will receive open-label asenapine for 26 weeks. Throughout the study,~     observations will be made on each participant at various times to assess the long-term~     safety, tolerability and efficacy of the study treatment.~   "
181414|NCT01190254|"~     This study is designed to evaluate whether asenapine, which is approved by the United States~     Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also~     effective in adolescents with schizophrenia. Participants who qualify for the study will be~     randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily~     [BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each~     participant at various times to assess the efficacy and safety of the study treatment. The~     primary objective of the trial is to demonstrate significant superiority of at least one~     asenapine dose to placebo, as measured by the change from baseline of the Positive and~     Negative Syndrome Scale (PANSS) total score at Day 56.~   "
181415|NCT01190241|"~     The purpose of this study is to select targeted treatment based on ex vivo kinase activity~     inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for~     whom no standard treatment is available.~   "
181416|NCT01190228|"~     The aim of the study is to investigate the memory immune response and the yearly persistence~     of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese~     Encephalitis Chimeric Virus Vaccine (JE-CV) in participants previously vaccinated with JE-CV~     vaccine.~      Objectives:~        -  To describe JE immune status before and after JE-CV vaccination in subjects previously~          vaccinated with JE-CV vaccine~        -  To describe the immune status before and after JE-CV vaccination in JE-naïve control~          subjects.~        -  To describe the safety (in terms of solicited and unsolicited adverse events) of a~          single dose of JE-CV vaccine up to 6 months after the last vaccination.~        -  To describe all related serious adverse events (SAEs) and related deaths from 6 months~          to 5 years after vaccination in JE-CV-primed subjects.~   "
181417|NCT01190215|"~     This study is designed to assess the immunogenicity, reactogenicity and safety following~     vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been~     vaccinated with one dose of PandemrixTM at the age of 10-17 years.~   "
181418|NCT01190202|"~     The aim of this epidemiology study is to characterize in a standardized way malaria~     transmission intensity at the clinical trial centers participating in study 110021~     (NCT00866619).~   "
181419|NCT01190189|"~     This extension study is designed to assess the safety of GSK Biological's human~     papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study~     NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV~     vaccine is not indicated for the subject's age group (26 years and older). This study is thus~     conducted to enable all women who received the control placebo in the primary NCT00294047~     study to receive the GSK580299 vaccine.~   "
181420|NCT01190176|"~     This study is intended to provide up to a maximum of four years of annual oncogenic human~     papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study~     subjects who displayed normal cervical cytology but tested positive for oncogenic HPV~     infection at their concluding NCT00294047 study visit.~      Women who were pregnant at their concluding NCT00294047 study visit may also be included in~     this study, as no cervical sample could be collected at that visit.~      The objectives and outcome measures of the primary phase (NCT00294047) are presented in a~     separate protocol posting.~   "
181421|NCT01190163|"~     This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in~     unfavorable cervix pregnant women with 38 or more weeks of gestational age.~   "
181422|NCT01190150|"~     This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic~     acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female~     subjects ages 12-16 years with heavy menstrual bleeding.~   "
181423|NCT01190137|"~     There are two different types of vitamin D - vitamin D3 (animal source) and vitamin D2 (plant~     source). Almost all the usual vitamin D preparations for infants available in Canadian~     pharmacies contain vitamin D3 which may not be suitable for families who avoid animal~     products for social or religious reasons. The purpose of this study is to learn more about~     the two forms of vitamin D and if blood levels of vitamin D are similar in infants after~     taking them. Forty-eight breastfed infants will be randomly assigned to 400 IU of either~     vitamin D2 or D3 supplement for 3 months starting at 1 month of age. The difference in blood~     vitamin D levels, after 3 months of supplementation, between the two groups will help~     determine if the two supplements are equal.~   "
181479|NCT01189396|"~     The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic~     profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active~     control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in~     escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical~     dose.~   "
181480|NCT01189383|"~     The purpose of the study is to gather data on feasibility as well as immune and clinical~     efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or~     stage IV melanoma~   "
181424|NCT01190124|"~     The purpose of this study is to evaluate the efficacy of raltegravir with optimized~     background therapy (OBT) in multiple-experienced HIV infected patients, measured by the~     proportion of patients with undetectable viral load and the mean increase of CD4 cells count~     at week 24 and 48.~      It is also intended to evaluate:~        -  viral load suppression and the mean increase of CD4 cells count at week 24 and 48 in~          patients who needed to change antiretroviral (ARV) therapy due to inacceptable toxicity,~          as determined by the investigator, including patients who needed to replace T20.~        -  efficacy of raltegravir with OBT in HIV-2 infected patients that were included in this~          cohort, measured by the percentage of patients with undetectable viral load and the mean~          change of CD4 cells count at week 24 and 48.~      Study hypotheses:~        -  Raltegravir with OBT is effective in achieving and maintaining a long term virologic~          suppression along with a significant increase on CD4 cells count in both HIV-1 and HIV-2~          infected patients.~        -  Patients who replaced T20 by raltegravir, due to intolerance, are able to maintain long~          term virologic suppression.~   "
181425|NCT01190111|"~     This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7~     (CYT107), the biological activity and safety of repeated cycles of CYT107, for a maximum of 4~     cycles within 21 months and a maximum of 3 cycles within 12 months.~   "
181426|NCT01190098|"~     Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a~     negative impact on quality of life. Though unproven, these problems are often blamed on~     anti-seizure medications. The purpose of this study is to investigate the impact of the~     anti-seizure medication Lacosamide (Vimpat®) on sleep and wakefulness in adults with focal~     (partial onset) seizures.~      Focal epilepsy, also called partial epilepsy, is a disorder characterized by seizures arising~     from a localized network of neurons in the brain. Focal seizures usually begin a sensation or~     involuntary movement of a part of the body, an unusual feeling, or a disturbance in hearing,~     smell, vision, or consciousness. The study is open to adults 18 and older with focal~     seizures.~      Participation involves a physical exam, sleep testing at the Sleep Center, blood tests,~     completion of study questionnaires/diaries, and a random assignment to either take the study~     drug or placebo (often called a look alike or sugar pill) for 5 to 8 weeks. There are 5~     study visits. Participants will receive compensation for time spent in the study.~      If you would like more information on this study please contact the Cleveland Clinic Sleep~     Center:~      Dr. Nancy Foldvary-Schaefer: 216-445-2990 Monica Bruton: 216-444-6718~   "
181427|NCT01190085|"~     Only a few medications are approved for the treatment of alcohol dependence and there exists~     a substantial need for discovering ways to provide more effective treatments. Accordingly,~     identifying new potential neuropharmacological targets in the treatment of alcohol dependence~     represents a high priority in public health. Ghrelin is a 28-amino acid peptide acting as the~     endogenous ligand for the growth hormone secretagogue receptor (GHS-R). Ghrelin was first~     isolated from the stomach, but a central hypothalamic production of ghrelin has also been~     demonstrated. Ghrelin plays a key role in the regulation of appetite. Consistent with the~     common neurobiological substrates for control of food and alcohol consumption, preclinical~     investigations suggest that ghrelin plays a role in the neurobiology of alcohol dependence,~     thus representing a new potential neuropharmacology target. In keeping with the preclinical~     studies, human investigations showed that alcohol consumption affects blood ghrelin levels~     and that blood ghrelin levels significantly and positively correlate with craving~     measurements in alcohol-dependent individuals. The effects of exogenous ghrelin injected~     intravenous (i.v.) in alcohol-dependent individuals, however, have never been investigated.~     The current project proposes a randomized double-blind placebo-controlled 3-group~     between-subject laboratory study aimed at investigating the effects of exogenous ghrelin i.v.~     on non-treatment seeking alcohol-dependent subjects in terms of urges to drink, attention to~     cues and related psychophysiological measures. This project has the goals to: i) conduct an~     alcohol laboratory study testing the role of ghrelin i.v., therefore demonstrating the~     feasibility of such a study and the safety of ghrelin i.v. when administered to~     alcohol-dependent individuals; and ii) explore the effects of ghrelin i.v. on alcohol craving~     assessed under controlled conditions, such as a cue-reactivity (CR) experiment.~      This study will address whether alcohol craving is affected when ghrelin levels are modified~     acutely via a ghrelin i.v. injection. Given the crucial need to expand our understanding of~     the underlying neurobiology of alcoholism, this study potentially will lead to identify new~     targets for the development of pharmacological treatments that may improve interventions for~     alcohol dependent individuals.~   "
181428|NCT01190072|"~     The purpose of the study is to follow the management of blood lipids in patients with planned~     percutaneous coronary intervention (widening of coronary vessels) in a period from 6 to 10~     weeks after the intervention.~   "
181429|NCT01190059|"~     The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for~     donor lungs that fail to meet standard acceptability criteria. This advanced assessment might~     lead to increased utilization rates of donor lungs and improved outcomes after lung~     transplantation.~   "
181430|NCT01190046|"~     The purpose of this study is to define the effects of chronic disuse on skeletal muscle~     structure and function in elderly individuals at the cellular and molecular level by~     examining elderly characterized by chronic muscle disuse (patients with knee osteoarthritis)~     and healthy elderly no evidence of knee osteoarthritis and normal physical activity levels.~   "
181431|NCT01190033|"~     This is a prospective, randomized, double-blind, placebo-controlled study. In an initial~     phase, 100 patients with chronic low back pain will be included in this study. The patients~     will be recruited through magazines and newspapers to take part in a screening for treatment~     of low back pain. This screening will involve the evaluation of data such as history and~     physical examination to classify the patient in the group of nonspecific low back pain,~     excluding patients with neurological alterations and the so-called Red-Flags.~      Procedures After the initial screening the patients will undergo diagnostic blocks of the~     medial branch of lumbar vertebrae L2, L3, L4 , L5 and of the first sacral vertebra (S1) with~     lidocaine and control with distilled water. The patients that present more than 50% of pain~     improvement, evaluated by the Likert scale after 30 minutes will form the study group, while~     the patients that do not present pain improvement with lidocaine or that present pain~     improvement with distilled water will be excluded.~      The medial branch block consists of the insertion of a 90mm, 25-gauge needle through the skin~     with radioscopic control up to the medial branch topography. Infusion of 1ml of 2% lidocaine~     should be performed in each medial branch of the abovementioned vertebrae. Control is~     executed in the same manner yet with infusion of 1ml of distilled water.~      Through the use of the diagnostic block we will have 40 patients selected for the second~     phase of the study. Once defined the study group should be evaluated before the procedure~     through the Oswestry, Roland Morris, SF-36 and VAS questionnaires.~      In the second phase of the study the patients will be randomized. The random division into~     two groups will be performed through a computerized program of random numbers. The~     randomization result will be kept in matt sealed envelopes to guarantee secrecy of the~     allocation. The neurolysis procedure will be carried out in the first group, consisting of 20~     patients, and the placebo or sham procedure with the second group, also with 20 patients.~      The neurolysis procedure will be carried out under sterile conditions, with the patient lying~     prone and with the neurotome insertion sites anesthetized with 2ml of 1% lidocaine. The~     neurotome (Smith & Nephew - RF) will be used for the procedure. The neurotome is a~     radiofrequency apparatus mounted on a 10cm electrode type 22 needle with a 5mm exposure tip.~     The neurotome should be introduced percutaneously in a manner similar to that adopted in the~     medial branch block through radioscopic control. The temperature of the electrode after its~     placement in the correct position is then raised to 80 °C for 90 seconds. Two neurotomies~     should be performed for each facet, one proximally and the other distally, due to double~     innervation of each facet. In the patients of the placebo group the procedure will be the~     same only the temperature of the neurotome will not be raised. This will be performed in a~     blind manner, as before starting the procedure, the surgeon will show the assistant who turns~     the device on or not the envelope containing the patient's group (placebo or neurotomy), yet~     the surgeon will not be informed whether the device has been turned on or not, having to~     perform the procedure in the same manner in both groups.~      The patients will then be reevaluated in the first month, 3 months after, 6 months after and~     12 months after the procedure. The assessors will not be informed of the group to which the~     patient belongs, and the same scales performed in the preoperative period will be used here.~   "
181432|NCT01190020|"~     Lubiprostone, a chloride channel activator, has been shown to improve symptoms of chronic~     constipation, largely by enhancing chloride-rich intestinal fluid secretion. Whether~     Lubiprostone has effects on colonic methanogenesis is not known. The investigators~     hypothesize that the effects of Lubiprostone may in part be due to its effects on altering~     colonic flora, particularly methanogenic flora.~      By altering the colonic stasis of stool and through more efficient clearance of digestive~     residue, the investigators anticipate that Lubiprostone may either inhibit or promote better~     excretion of methanogenic flora, and thereby decrease the gut load of methane producing~     bacteria. In turn, this may lead to enhanced colonic smooth muscle contraction and an~     increased rate of spontaneous bowel movements and reduction of constipation symptoms.~      The aim is to investigate the effects of Lubiprostone on intestinal methane production and~     bowel symptoms in patients with chronic constipation, by performing a randomized, double~     blind, placebo controlled study.~   "
181433|NCT01190007|"~     The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5~     mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in~     Japanese patients with both of hypertension and hypercholesterolemia, or with both angina~     pectoris and hypercholesterolemia.~   "
181481|NCT01189370|"~     The purpose of this study is to determine whether an increase in the dose of sorafenib when~     given over five instead of 7 days/week, will result in an improvement of the response rate~     (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib~     will control your cancer, without causing a significant increase in side effects.~   "
186704|NCT01120769|"~     The purpose of this study is to test the hypothesis that acetaminophen will reduce lipid~     peroxidation and isoprostane formation during reperfusion after percutaneous~     revascularization for acute myocardial infarction.~   "
181434|NCT01189994|"~     Fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep~     disturbances and depression. It affects population at a socioeconomically active age and~     represents a burden for the patients and the health care system due to its personal and~     functional implications. At this moment, there is no completely effective treatment for~     fibromyalgia, and acupuncture has been a promising alternative. This trial aims to evaluate~     if addition of acupuncture to standard care represents an improvement in comparison with~     standard care only. Thus, patients enrolled in this trial will be randomly allocated into one~     of two groups: group A, who besides standard treatment will receive 12 sessions of~     acupuncture; and group B, who will receive standard care with monthly orientation sessions~     for the same period. Patients will be evaluated at baseline, after completion of acupuncture~     treatment or orientation, and after an additional 12-week follow up. Evaluation will be based~     on diaries of pain and medication, and standard scales of pain, quality of life and~     disability.~   "
181435|NCT01189981|"~     All over the world 0.8 % of all live children are born with a Congenital Heart Disease (CHD)~     due to genetic end environmental causes. Advanced treatment and care has enhanced survival~     substantially, and adults with CHD are a growing population requiring continuous monitoring~     and care. Presently 25% of young adults acquire complicating Cardio Vascular Diseases (CVD)~     in young adulthood amongst other co-morbidities.~      It is known that adolescents with CHD are not as physical fit (PF) as their cardiac~     capability allows, most likely for reasons concerning safety, ability plus inactive everyday~     life. However, in 2006 The European Society of Cardiology states, that regular exercise at~     recommended levels can be performed and should be encouraged in all patients with CHD.~     Training programmes in hospitals have an effect on PF and Quality of Life (QoL) for the few,~     as most adolescents' find it impossible to fit into everyday life.~      It is the investigators hypothesis that an eHealth intervention, to facilitate intensive~     exercise in the patients' neighbourhood environs, may improve physical fitness more~     efficiently than standard lifestyle education.~      The purpose of the study is to create evidence to recommend an efficient, fun and safe~     cardiac rehabilitation programme to adolescents with CHD.~      Primary outcome measure~      Cardiopulmonary exercise capacity: Online V02 max bicycle test~      Secondary outcome measure~      Level of physical exercise: Actigraph and Questionnaire~      Tertiary outcome measure~      Quality of Life: PedsQl~      Prevail is a national prospective, randomized clinical trial including 216 adolescents aged~     13-16 years, who have had cardiac surgery in childhood owing to complex CHD. The patients~     included are all recommended to be as physical active as their healthy peers and pursue the~     principle guideline from The National Board of Health: All children and young people must be~     physically active for at least 60 minutes a day, preferably longer. Patients with mental~     retardation and FEV1 at baseline < 80% of predicted are excluded.~      The risk of participating in the purposed trial is not regarded as higher than everyday daily~     living.~      Results will be interpreted according to affiliation to health related fitness clusters.~   "
181436|NCT01189968|"~     The purpose of this study is to test the safety and determine the optimal dose of a new drug,~     demcizumab (OMP-21M18), when given in combination with carboplatin and pemetrexed, a standard~     drug treatment regimen for non-squamous non-small cell lung cancer (NSCLC). Participants must~     not have received prior chemotherapy for their NSCLC. Demcizumab is a humanized monoclonal~     antibody (a protein made in the laboratory) developed to target cancer stem cells. The way~     the body handles demcizumab will also be investigated.~      Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain.~     Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your~     eligibility to take part in this study, and then if enrolled in the study you will receive~     intravenous (in the vein) infusions of the demcizumab, carboplatin, and pemetrexed~     administered on the same day, every 21 days for 4 cycles, or until it has been shown that~     your cancer has progressed. If your physician decides to delay treatment with one of the~     agents due to side effects, the other agents may still be administered as scheduled. After 4~     cycles, if you have stable or improved disease, you will continue to receive pemetrexed once~     every 21 days as maintenance therapy. You will undergo assessments every 8 weeks to determine~     the status of your disease.~   "
181437|NCT01189955|"~     Consecutive patients treated for thyroid enlargement at our institution were evaluated for~     inclusion. Participants were randomly allocated to receive total thyroidectomy using harmonic~     scalpel HS or using ligature conventional thyroidectomy CT Follow-up visits were after 1~     week, 1 month, and 6 months, Study variables included operative time, length of incision,~     operative bleeding, postoperative drainage, hospital stay and complication.~      one hundred and thirty patients with thyroid enlargement were randomized and completed the~     study.~   "
181438|NCT01189942|"~     The purpose of this study is to test the safety and determine the optimal dose of a new drug,~     OMP-21M18, when given in combination with FOLFIRI, a standard drug treatment for advanced~     colorectal cancer. Participants must not have had more than one chemotherapy regimen for~     their metastatic disease. OMP-21M18 is a humanized monoclonal antibody (a protein made in the~     laboratory) developed to target cancer stem cells. The way the body handles OMP-21M18 will~     also be investigated.~      Up to 32 participants, 21 years or older, at up to 6 centres in Australia and New Zealand,~     will receive intravenous infusions of OMP-21M18 followed by FOLFIRI every two weeks, until~     disease progression or limited by drug toxicity. After 8 weeks, participants will undergo~     assessments to determine their disease status. If there is no evidence of disease progression~     participants will continue to receive infusions of OMP-21M18 and FOLFIRI every second week,~     until disease progression.~   "
181439|NCT01189929|"~     The purpose of this study is to test the safety and determine the optimal dose of a new~     experimental drug, demcizumab (OMP-21M18), when given in combination with gemcitabine with or~     without (+/-) Abraxane®. Historically, single agent gemcitabine has been the standard~     treatment for pancreatic cancer. However, recent data suggests that gemcitabine plus~     Abraxane® may be superior to gemcitabine alone, thus this combination is emerging as the new~     standard therapy for pancreatic cancer. However, Abraxane® has not been approved for the~     treatment of pancreatic cancer at this time. Demcizumab is a humanized monoclonal antibody~     and was developed to target cancer stem cells. This study is sponsored by OncoMed~     Pharmaceuticals, which is referred to as OncoMed or the Sponsor in this consent form. The~     study is designed to test the safety of demcizumab at different dose levels when given with~     gemcitabine +/- Abraxane® and the effects, both good and bad, that it has on participants.~     Demcizumab may block the growth of cancer stem cells, the remaining tumor cells, and it may~     also prevent the growth of new blood vessels that tumors need to grow and spread. Although~     demcizumab has been administered with gemcitabine to cancer patients, it has not been given~     in combination with gemcitabine and Abraxane®; thus, it is not known if it will provide any~     benefit to participants and may cause harmful side effects.~   "
182089|NCT01181414|"~     The aim of the present study is to compare the response to cardiac resynchronization therapy~     (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF)~     depending on atrio ventricular junction (AVJ) is ablated or not.~   "
181440|NCT01189916|"~     Natural orifice translumenal endoscopic surgery (NOTES) has revolutionized the concept of~     minimally invasive surgery. NOTES is currently performed through transgastric or transvaginal~     approaches. The transvaginal approach is technically easier, but is only available to women.~     A transrectal approach has been proposed as a potential alternative to transvaginal NOTES for~     men. Fortunately, the technology to facilitate transrectal access and closure for NOTES has~     been in use for over twenty years, in the form of transanal endoscopic microsurgery (TEM)~     platforms.~      We hypothesize that transrectal NOTES appendectomy is feasible in humans using a flexible~     endoscope and a TEM platform to assist with transrectal access and closure. After a~     pre-clinical study involving 5 cadavers, we will perform a clinical study of 10 transrectal~     NOTES appendectomies in patients already scheduled to undergo laparoscopic total~     proctocolectomy or total abdominal colectomy. The tissues involved in the NOTES procedure~     will be removed as part of the patient's originally scheduled operation, reducing the risk of~     morbidity as a result of an inadequate transrectal closure or appendiceal stump leak. We will~     measure operative times, complication rates, peritoneal contamination, and assess the~     integrity of the rectotomy closures. We hope to show that transrectal NOTES appendectomy is~     clinically feasible in humans using a TEM platform.~   "
181441|NCT01189903|"~     1. Primary Endpoints~             -  Biomarker data suggestive of regorafenib-mediated inhibition of the RAS-RAF-~               MEK-ERK signal transduction pathway,of various tyrosine kinase receptors and/or of~               angiogenesis.~             -  Evaluation of potential relationships between biomarker data and clinical activity.~             -  Evaluation of a novel biomarker technology (Prometheus COPIA platform)~        2. Secondary Endpoints~             -  Biomarker data suggestive of regorafenib-mediated effects on circulating rare~               cells.~             -  Comparison of tumor genetic profiles obtained using DNA isolated from plasma, tumor~               biopsies and circulating tumor cells.~             -  Patient safety data~             -  Pharmacokinetics of regorafenib~             -  Changes in tumor metabolic activity as measured by PET CT scan (optional)~   "
181442|NCT01189890|"~     The primary objectives of this study are to determine if sitagliptin treatment is not~     inferior to that of glimepiride as measured by the change in baseline hemoglobin A1C (HbA1C)~     after 30 weeks of treatment, and if sitagliptin treatment results in a lower incidence of~     symptomatic hypoglycemia compared to that of glimepiride. The study will also evaluate if~     sitagliptin treatment, compared to glimepiride results in improvements in fasting plasma~     glucose (FPG) levels, and plasma lipid levels after 30 weeks of treatment. Participants will~     be randomized to either sitagliptin or glimepiride treatment after eligibility for study~     participation is determined during screening and washout study phases. Participants and study~     staff will not know to which treatment group they have been randomized (double-blind design).~     The duration of study participation will be up to 40 weeks (with 9 clinic visits). This will~     include a screening phase (Visit 1 to Visit 2) of 2 weeks maximum; a 6-week (Visits 2 to 3)~     oral antihyperglycemic agent (AHA) wash-out phase (for those who have been taking a AHA prior~     to the study); a placebo run-in phase (Visits 3 to 4), followed by up to 30 weeks of~     treatment with study medication.~   "
181443|NCT01189877|"~     The purpose of this study is to see if the cells in rectal cancer are oxygen-starved, or~     hypoxic. We know that as cancers grow bigger, parts of them are cut off from the oxygen~     supply and they become hypoxic, basically, lacking oxygen. Research has shown that cells that~     are oxygen-starved respond differently to treatment such as chemotherapy and radiation when~     compared to cells that are oxygen rich.~   "
181444|NCT01189864|"~     The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced~     cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and~     biochemical stability of the cornea by inducing additional cross-links within or between~     collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study~     is to generate data for presentation at medical meetings and for peer-review publication. The~     data generated by this study will not be submitted to the FDA to support commercialization of~     these riboflavin drops.~   "
181445|NCT01189851|"~     Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision~     (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and~     contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to evaluate the~     extent of disease.~   "
181446|NCT01189838|"~     Cysteine-rich 61 (Cyr61), a member of CCN family, regulates cell migration, proliferation,~     apoptosis, and angiogenesis, cell adhesion, migration, proliferation, survival,~     differentiation, apoptosis, angiogenesis, and extracellular matrix production. Evidences show~     strong correlations of aberrant Cyr61 expression in cancers of numerous organs and tissues.~     However, the expression and effect of Cyr61 in transitional cell carcinoma (TCC), the most~     common urinary tract cancer in Taiwan, remains undiscovered. Based on previous studies of~     Cyr61 in other cancer, the investigators hypothesize that Cyr61 may mediate TCC cell~     proliferation and migration; and associated with disease progression and recurrent. Thus the~     investigators conduct this project to study the role of Cyr61 in the pathogenesis of TCC. The~     investigators will retrospectively review medical history of patients with TCC treated at our~     institutes. Cyr61 immunohistochemical stain of their surgical samples will be performed. The~     correlation of Cyr61 expression of TCC and patients' clinical courses will be investigated.~   "
181447|NCT01189825|"~     The major aim of the this study is to replicate findings of previous research that examined~     the effects of acute exercise on sexual arousal in women in a novel population, namely, women~     taking antidepressants of the selective serotonin reuptake inhibitors (SSRI) or selective~     serotonin and norepinephrine reuptake inhibitors (SNRI) class. In previous studies it has~     been found that acute, moderate-intensity exercise facilitated physiological sexual arousal~     responses in healthy, sexually functional women. However, it is known that antidepressants~     may induce sexual dysfunction, and thus in the present study, the investigators are examining~     whether acute exercise may facilitate sexual responses in women with taking antidepressants,~     including women with antidepressant-related sexual dysfunction.~   "
181448|NCT01189812|"~     The investigators hypothesize that patients receiving citalopram in combination with lithium~     will have a greater reduction in depressive symptoms than patients receiving citalopram in~     combination with placebo.~   "
182114|NCT01181089|"~     This is a prospective, randomized, multicenter, dose escalation study to determine subject~     safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS~   "
181449|NCT01189799|"~     The primary objective of the study is to test the incremental efficacy and outcomes of an~     aftercare program of Cognitive Behavioral Therapy combined with motivational therapy (CBT-MT)~     relative to treatment as usual (TAU) in improving depression, substance use, and healthcare~     outcomes in a population with drug dependence and comorbid major depressive disorder (MDD).~     The investigators expect that among drug-dependent patients with comorbid MDD, CBT-MT will~     yield better clinical outcomes relative to TAU in reducing depressive symptoms and substance~     use and improving healthcare outcomes during treatment.~      Secondary Objectives:~        1. Test efficacy and outcomes of CBT-MT and TAU~        2. Evaluate the differential effect of CBT-MT versus TAU on HIV-risk behavior of~          participants,~        3. To evaluate the impact of cognitive functioning on treatment retention and outcomes, and~        4. To explore additional psychosocial, demographic, and diagnostic factors (e.g., age,~          gender, education level, motivation for change, social support) that may be associated~          with treatment outcome and retention in this high need population.~      This study will include approximately 80 participants randomized to either 12 weeks of~     motivational therapy or treatment as usual. Both treatments will meet once weekly for 60~     minutes. Participants will be recruited from the Adult Partial Hospitalization program at~     UCLA. During the active treatment phase, participants will attend clinic weekly for~     collection of data and urine specimens.~        1. For those randomly assigned to CBT-MT, they will meet with a therapist in a group format~          for 60-minute sessions once weekly.~           a. Each CBT-MT session will begin with 20 minutes of motivational therapy (MT), followed~          by 40 minutes of CBT content.~        2. Those randomly assigned to TAU, they will attend a weekly 60-minute Dual Recovery~          Anonymous self-help group.~   "
181450|NCT01189786|"~     Participants are being asked to take part in this study because treatment of his or her~     disease requires a stem cell transplant. Stem cells or mother cells are the source of~     normal blood cells and lead to recovery of blood counts after bone marrow transplantation.~     Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother)~     for the participant and his or her disease does not permit enough time to identify another~     donor (like someone from a registry list that is not his or her relative) or another suitable~     donor has not been identified. However, a close relative of the patient has been identified~     whose stem cells are not a perfect match, but can be used.~      Alternatively, the patient may have already received a stem cell transplant but have evidence~     of mixed chimerism, which means some of the patient's own bone marrow cells are present,~     rather than all of the donor's cells. This may lead to an increased risk of the disease~     coming back. Or, the patient may have all donor cells but his or her bone marrow is not~     working very well, which may lead to frequent blood or platelet (cells that help in clotting~     blood) transfusions or infection.~      Regardless of the reason, it may be necessary to isolate stem cells from a haploidentical~     (half-match) donor in order to provide bone marrow function. Because the stem cells from the~     donor are only half-matched to the participant, the risk of graft-versus-host disease (GvHD)~     is very high. GvHD is a complication after transplant caused by donor T cells (graft) that~     attack the transplant recipient, and this complication can cause death after transplant.~     Thus, it is important that the donor's blood cells are treated to minimize cells that are~     most likely to attack the host's tissues. This is done by using a special device to capture~     the CD34+ stem cells from the donor's stem cell product prior to giving the cells to the~     host. This method minimizes the donor T cells, which are responsible for causing GvHD.~      Purpose: In an effort to lower the occurrences and severity of graft-versus-host disease in~     patients and to lower the rate of transplant failure, investigators would like to specially~     treat the donor's blood cells to minimize the cells that are most likely to attack the~     patient's tissues.~   "
181451|NCT01189773|"~     Prospective study to evaluate the additive value of codeine on ibuprofen in the management of~     pediatric patient with a trauma of a limb.~   "
181452|NCT01189760|"~     This study will evaluate the safety and efficacy of botulinum toxin Type A compared to~     placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)~   "
181453|NCT01189747|"~     This study will evaluate the safety and efficacy of botulinum toxin Type A compared to~     placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).~   "
181454|NCT01189734|"~     Many options are available for management of common bile duct stones. the most recent~     development in this field is single-session approach by one of two methods; laparoscopic~     common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the~     investigators prospectively compare these two methods for management of patients with~     preoperatively diagnosed common bile duct stones to settle the best option.~   "
181455|NCT01189721|"~     The investigators hypothesize that propofol infusion during surgery can affect the~     remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by~     a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey~     filament.~   "
181456|NCT01189708|"~     The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh~     as prevention of incisional hernia after elective open abdominal aortic aneurysm repair.~     According to the literature these patients have an increased risk for an incisional hernia.~     By the implantation of an artificial mesh into the abdominal wall during the first abdominal~     aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies~     incisional hernia rates as low as 0% have been achieved.~      Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into~     two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.~   "
181457|NCT01189695|"~     The objective of this study is to determine efficacy of ritonavir-boosted lopinavir~     monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed~     Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received~     salvage protease-inhibitor (PI) based regimens.~   "
181458|NCT01189682|"~     Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine~     impregnated sponge has been proven to reduce the rate of major catheter related infections in~     ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of~     cases before planned changes and the rate of unplanned dressing is significantly associated~     with the major catheter related infections.~      Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease~     the rate of major catheter related infection as compared to non impregnated dressings and to~     demonstrate that highly adhesive dressing decrease the rate of detached dressings.~      Secondary objectives:~        -  To demonstrate that the use of high performance dressing decrease the rate of unstuck~          dressing and the rate of catheter infections.~        -  To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).~        -  To calculate the cost saving of each dressings~   "
181459|NCT01189669|"~     This is a dietary intervention study designed to assess the impact of long chain (LC) n-3~     polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS).~     Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the~     adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary~     supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.~   "
181460|NCT01189656|"~     To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA~     vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next~     dosing regimen.~   "
181461|NCT01189643|"~     This study adds irinotecan, temozolomide and bevacizumab to the chemotherapy regimen~     currently used to treat Desmoplastic small round cell tumor (DSRCT). The investigators are~     doing this study to find out what effects, good and/or bad, the combination of irinotecan,~     temozolomide and bevacizumab has on the patient and the DSRCT cancer.~   "
181462|NCT01189630|"~     The Observational Study in the Real World of Implantable Electronic Cardiac Devices will~     enable the construction of an electronic database with local access to clinical information,~     which will collect and disseminate epidemiologic data on demography, cardiovascular mortality~     and morbidity, and potential risk factors for a selected group of patients. These clinical~     variables will be analyzed against the data, as based in the programming of devices and the~     diagnostics. Approved descriptive statistics and analyses will be made available via~     Internet. The study will describe statistical indexes on sub-groups representing more than~     10% of total of datasets.~      The study will be open to include any patient that had a Medtronic electronic device~     implanted, pacemakers, ICD, ICD with CRP. The study will be also adapted for devices~     implanted in the present and for devices to be implanted in patients in the future.~   "
181463|NCT01189617|"~     This is a one-week study designed to test the safety of an all-in-one body and personal~     lubricant product during in-home use.~   "
181464|NCT01189604|"~     Phase IIB study to find the optimal dose rate range of propofol to maintain~     minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal~     polypectomy.~   "
181465|NCT01189591|"~     Sleep deprivation can acutely reverse depressive symptoms in patients with major depression.~     Although underlying mechanisms of the antidepressant action in sleep deprivation are unclear,~     many of these observations can be explained by abnormal slow wave homeostasis. This study~     will test the prediction that selectively reducing slow waves during sleep (slow wave~     deprivation; SWD), without disrupting total sleep time, will yield an antidepressant effect.~   "
181466|NCT01189578|"~     The purpose of this study is to compare individuals with cocaine dependence to recreational~     users of cocaine in terms of their brain reactivity to cocaine cues, in hopes that this~     comparison may help us better understand the transition from recreational to compulsive~     cocaine use.~   "
181467|NCT01189565|"~     The purpose of this study is to evaluate the incidence of low levels of oxygen as determined~     by standard pulse oximetry monitor in patients who have had total hip or knee~     replacement/revision.~   "
181468|NCT01189552|"~     The objective of the current study is to evaluate the effects of a brief, behavioral~     activation treatment (the Life Enhancement Treatment for Substance Use; LET'S ACT) on long~     term outcomes of substance use, HIV risk behaviors and mechanisms of treatment response~     (depressive symptoms, environmental reward, behavioral activation).~   "
181469|NCT01189526|"~     This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison~     with macular laser photocoagulation as treatments for macular edema secondary to branch~     retinal vein occlusion.~      Characteristics of this study is as below~        1. Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs.~          macular laser photocoagulation)~        2. After 48 weeks follow up, functional change(visual acuity)and anatomical change (central~          retinal thickness) would be evaluated~   "
181470|NCT01189513|"~     The goal of this clinical research study is to find the highest tolerable dose of SCH 900105~     that can be given to patients with glioblastoma before surgery. The safety of this drug will~     also be studied.~   "
181471|NCT01189500|"~     The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on~     the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy~     post-menopausal female subjects. This study will also evaluate the safety and tolerability of~     Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female~     subjects.~   "
181472|NCT01189487|"~     Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity~     for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet~     been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and~     safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin~     sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.~   "
181473|NCT01189474|"~     Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands~     dysfunction .~      Its objective is to Collect information from patients and ophthalmologists specialized in~     ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.~      This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.~      Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two~     uses per day) and complete a questionnaire every two days during the first week and then once~     a week the next two weeks.~   "
181474|NCT01189461|"~     This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular~     edema. The hypothesis is that pegaptanib is safe and efficacious in patients with diabetic~     macular edema.~   "
181475|NCT01189448|"~     Background : When a mother contracts toxoplasmosis during pregnancy, the parasite may be~     transmitted from to her unborn child. This results in congenital toxoplasmosis, which may~     cause damage to the eyes and nervous system of the child. To date, no method has been proved~     effective to prevent this transmission. In France, spiramycin is usually prescribed to women~     who have toxoplasma seroconversion in pregnancy, however its efficacy has not been~     determined. The standard treatment for toxoplasmosis is the combination of the antiparasitic~     drugs pyrimethamine and sulfadiazine, but this strategy has not been evaluated for the~     prevention of mother-to-child transmission.~      Purpose : Randomized phase 3 trial to determine whether pyrimethamine + sulfadiazine is more~     effective than spiramycin to prevent congenital toxoplasmosis.~   "
181476|NCT01189435|"~     The purpose of this study is to measure the ability of erlotinib to effectively treat~     recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with~     erlotinib or gefitinib received in the post-surgical or post-radiation setting.~   "
181477|NCT01189422|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and~     pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively~     recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first~     signs and symptoms of disease to a physician prior to randomization.~   "
181478|NCT01189409|"~     This is a study to compare the efficacy and tolerability of two laxatives for treatment of~     opioid-induced constipation in adult outpatients with cancer treated at the British Columbia~     Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will~     be randomly assigned to one of two treatment groups.~   "
181482|NCT01189357|"~     During the period 1989-1999, a number of patients underwent a meniscal transplantation. A few~     transplants were not successful. These patients form the population of this study. They all~     underwent a Total Knee Prosthesis (TKP) or unicompartmental knee prosthesis (UKP) after the~     failure of the transplants The goal of this study is to evaluate their current medical~     condition, to perform a survival analysis, and to determine the clinical outcome.~      The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and~     SF-36)and clinical examination.~   "
181483|NCT01189344|"~     Intestinal absorption of levothyroxine (LT4) tablets depends on its dissolution in gastric~     acid secretion, which is reduced after bariatric interventions. Impaired LT4 absorption due~     to low gastric dissolution has been reported in patients with atrophic or chronic gastritis.~     The objective of this study is to evaluate the absorption of LT4 tablets in morbidly obese~     patients before and after Roux-en-Y bariatric surgery.~   "
181484|NCT01189331|"~     Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical~     information about stenotic lesion,but the invasiveness and measuring difficulty of FFR make~     it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion~     severity and lately developing computational fluid dynamics could provide functional~     information. The investigators build a patient specific model of computational fluid dynamics~     by CT coronary angiography and evaluate the functional significance by measuring fractional~     flow reserve via CT coronary angiography and computational fluid dynamics.~   "
181485|NCT01189318|"~     In this study, patients with major depressive disorder (MDD) who have insomnia symptom are~     treated with Seroquel XR in an open-label manner for a 4-week period with repeated~     measurements of insomnia symptoms and sleep parameters using polysomnography.~   "
181486|NCT01189305|"~     In treating drug addiction, many studies of male patients show Behavioral Couples Therapy~     (BCT) helps the whole family (the drug abuser, the relationship partner, and their children)~     and is more effective than typical individual and group counseling. Only one study of BCT has~     been done with female drug-abusing patients, and results were promising but not definitive.~     The proposed study will test with married or cohabiting female drug-abusing patients whether~     BCT will produce more positive outcomes for the women, their male partners, and their~     children than standard individual counseling for the patient alone.~   "
181487|NCT01189292|"~     The study is to compare the postoperative recovery, as determined by postoperative nausea and~     vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in~     patients undergoing partial or total thyroidectomy.~   "
181488|NCT01189279|"~     This study will investigate the safety, tolerability, and pharmacokinetics of new formulation~     of bimatoprost following topical application in patients with alopecia. Two formulations of~     bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be~     investigated in Part 2. Part 2 will begin after Part 1 has completed.~   "
181489|NCT01189266|"~     This phase I/II trial studies the side effects and best dose of vorinostat and to see how~     well it works when given together with radiation therapy followed by maintenance therapy with~     vorinostat in treating younger patients with newly diagnosed diffuse intrinsic pontine glioma~     (a brainstem tumor). Vorinostat may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor~     cells. Giving vorinostat together with radiation therapy may kill more tumor cells.~   "
181490|NCT01189253|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. It is not yet known whether trabectedin is more effective than~     doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue~     sarcoma.~      PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared~     with doxorubicin hydrochloride and to see how well they work in treating patients with~     advanced or metastatic soft tissue sarcoma.~   "
181491|NCT01189240|"~     This phase I/II trial is studying the side effects and the best dose of RO4929097 to see how~     well it works when given together with bevacizumab compared to bevacizumab alone in treating~     patients with progressive or recurrent malignant glioma. RO4929097 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as bevacizumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Giving RO4929097 together with bevacizumab may kill more~     tumor cells.~   "
181492|NCT01189227|"~     RATIONALE: Drugs used in chemotherapy work in different ways to kill tumor cells or stop them~     from growing. Giving combination chemotherapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy~     after surgery may kill any remaining tumor cells. It is not yet known whether giving~     combination chemotherapy before and after surgery is more effective than giving combination~     chemotherapy after surgery.~      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before~     and after surgery to see how well it works compared to giving combination chemotherapy after~     surgery in treating patients with colorectal cancer with liver metastases that could be~     removed by surgery.~   "
181493|NCT01189214|"~     Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12~     weeks after adjusted methadone dose. During the study, the investigators will evaluate~     treatment response and adverse effect from multiple dimensions to elucidate the therapeutic~     effect of add-on memantine on addictive behaviors. It will also explore the possible~     advantage of this treatment on social re-adaptation and psychopathogenesis of opioid~     dependence.~   "
181516|NCT01188915|"~     After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by~     treatment, are the first cause of death.~      The investigators will estimate the risk to develop breast cancer in this population of women~     treated for hodgkin disease, and will propose women at high rish to participate in an~     intensive screening program based on an annual detection based on mammography, echography,~     and RMI.~   "
181517|NCT01188902|"~     The objectives of the proposed study are to assess the effect of walnut consumption on~     parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial~     function and blood pressure in healthy men and healthy postmenopausal women~   "
181494|NCT01189201|"~     The primary objective of the current study is to investigate the relative bioavailability of~     BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test)~     compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference),~     both in the fasting state. All 42 subjects entered are planned to be included in this~     comparison.~      The secondary objective is to investigate the relative bioavailability of BI 10773 /~     linagliptin fixed dose combination tablet after administration of a standardised high fat,~     high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin~     fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the~     42 subjects entered 18 subjects are planned to be included in this comparison.~      An additional objective is to investigate the relative bioavailability of a second~     formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation~     A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet~     (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned~     to be included in this comparison.~   "
181495|NCT01189188|"~     The investigators aim to determine if ultrasound guidance results in improved technique when~     drawing blood via a radial artery puncture.~   "
181496|NCT01189175|"~     The objective of the study is to investigate whether ketoconazole affects plasma exposure of~     BI 113823~   "
181497|NCT01189162|"~     The investigators hypothesize that while the extremely low birthweight (ELBW) infants (<1000~     g) may need NIMV for the treatment of RDS, larger infants or the smaller ones post extubation~     may enjoy the comfort benefits associated with HFNC while getting coparable respiratory~     support to NIMV.~   "
181498|NCT01189149|"~     Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV)~     fluids in hospitalized infants with acute viral bronchiolitis.~   "
181499|NCT01189136|"~     If patients are unable to have their foley catheter removed because their bladder is not~     emptying well, they may be eligible for study participation. This study is designed to~     evaluate whether Posterior Tibial Nerve Stimulation is effective in improving bladdder~     function after surgery. Study participation is limited to one day.~   "
181500|NCT01189123|"~     This study is to study the immune response to the flu vaccine in people 65 years old and~     older. Only adults 65 years old and older and who are getting their flu vaccine are being~     asked to join in this study. The investigators plan to enroll approximately 100 people in~     this study in the 2010-2011 flu season. Vanderbilt is working with the Centers for Disease~     Control and Prevention on this study.~      There will be 5 study visits. Up to 4 tablespoons of blood from a vein will be obtained prior~     to the flu shot. Return visits will be 1, 2, and 4 weeks later,with up to 4 tablespoons of~     blood drawn again. Patients will be randomized to receive either the standard dose or the~     high dose flu vaccine. Both flu vaccines are FDA-approved.~   "
181501|NCT01189110|"~     Thirty three percent of our veterans currently smoke. Encouraging smoking cessation continues~     to be a top priority for the Veteran's Administration as smoking is the single most important~     preventable risk factor for mortality and morbidity. This study attempts to determine whether~     auriculotherapy may be used as an effective alternative to usual pharmacological~     interventions currently offered. Identifying an efficacious alternative method to nicotine~     patch or bupropion would be highly beneficial to veterans who want to quit smoking. This~     clinical trial took place at the Veterans Administration Medical Center, in conjunction with~     the smoking cessation clinic. One hundred twenty five veterans, male and female, age 19 or~     older, who smoked a minimum of 10 cigarettes per day, were evaluated for enrollment and~     randomized to two groups- true auriculotherapy and sham auriculotherapy in this 6 week trial.~   "
181502|NCT01189097|"~     The purpose of this study is to determine the pharmacological effects and outcomes of DM~     therapy with this add-on study.~      And to determine the immunological changes between the baseline and the end point of the~     study.~   "
181503|NCT01189084|"~     The purpose of this observational study is to determine whether the vaccine (UB 311),~     targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term~     immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's~     disease (AD) who previously received UB 311-treatment. Amyloid beta was selected as the~     target antigen based on supporting evidence of the hypothesis that places the accumulation of~     amyloid beta at the initiating step of AD.~   "
181504|NCT01189071|"~     This will be a randomized two arm prospective study to evaluate postoperative ureteral stent~     pain. One arm will be given 3 days of preoperative darifenacin and the control group will~     have the standard of care which is no preoperative anticholinergic medication. The primary~     endpoints will be decreased pain scores and less ER visits and hospital admissions for stent~     difficulty. These will be assessed by a pain diary completed by the participant as well as a~     questionnaire when the participant returns to clinic for stent removal. Also included in~     evaluation of the primary end point will be patient phone calls, ER visits and admissions for~     stent difficulty. Secondary endpoints will be narcotic and postoperative anticholinergic use.~     This will also be assessed with the pain diary completed by the participant. Participants~     will be included in the study if they are undergoing a procedure that a stent will likely be~     required. This will include participants who will have ureteroscopy or extracorporeal shock~     wave lithotripsy and a stone 1 cm or larger. Also participants with stones smaller than 1 cm~     who due to anatomy of the ureter or kidney will likely need a stent on preoperative~     evaluation will also be included in the study. Included as well in the study are participants~     who will undergo renal or ureteral surgery that a ureteral stent will be utilized.~     Participants will be randomized after consent is obtained into two groups. One group will~     receive standard of care which is no preoperative anticholinergic medications. The second~     group will receive the three day treatment with darifenacin pre procedure. Participants in~     the second group will be instructed on side effects of darifenacin and given appropriate~     contact information prior to initiation of the medication. Both groups will be followed~     postoperatively with a pain diary. Postoperative follow up will continue until the stent is~     removed 1-2 weeks after the procedure. The exact time of stent removal will depend on the~     success and nature of the surgery and will be at the discretion of the surgeon. Participants~     will be able to voluntarily stop the medication for any reason as well as if they have~     serious side effects from the medication. Data to be collected from each group includes age,~     gender, race, prior ureteral stents, prior renal or ureteral surgery, past medical history,~     allergies, current medications and urinary complaints.~   "
181518|NCT01188889|"~     Patients participating in this study will have a diagnosis of Chronic Myeloid Leukemia. This~     study will evaluate whether the addition of an investigational drug called RAD001 given~     together with Imatinib will better target leukemia stem cells, causing them to die. Stem~     cells are a small population of cells, existing primarily within the bone marrow, and are~     believed to be responsible for the ongoing risk of disease relapse.~   "
181587|NCT01187992|"~     This study was designed to test the hypothesis that the addition of full-dose atorvastatin~     (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after~     non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse~     coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.~   "
181588|NCT01187979|"~     The purpose of this study is to assess the impact of a cash-incentivised prevention~     intervention on reducing HIV incidence rates in high-school learners in rural KwaZulu-Natal.~   "
181505|NCT01189058|"~     Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects~     thousands of Canadian children and families. Treatments for CP are generally ineffective, and~     have traditionally focused on the weak body rather than the injured brain. Understanding how~     the newborn brain responds to injuries like stroke (plasticity) carries the greatest~     potential for better treatments. We propose to study the ability of two interventions to~     modulate brain plasticity toward better function in children with stroke-induced CP. One is a~     rehabilitation method called constraint-induced movement therapy (CIMT), the other is a type~     of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is safe~     and comfortable for children and we recently showed it could improve motor function in~     children with stroke.~      We will perform a special study to test both treatments simultaneously. Children 7-18 years~     with stroke-induced CP will be recruited into the study from across Alberta. Each child will~     randomly receive either TMS, CIMT, both, or neither each day for two weeks while attending~     our new HemiKids Power Camp for motor learning. Improvements will be measured by trained~     therapists over 1 year. TMS will also measure brain plasticity, both initially and following~     treatment. Our lead investigator is an expert in both newborn stroke and TMS and has~     assembled an experienced team of accomplished collaborators to ensure the completion of this~     important work. This will be the largest study of children with CP examined in this manner.~     This will be the first clinical trial of non-invasive brain stimulation (TMS) in CP, the~     largest trial of CIMT (and the first exclusive to newborn stroke), and the first study~     allowing the direct comparison of two different therapies. In establishing the first~     dedicated pediatric TMS laboratory in Canada, we will be the first to measure plasticity~     changes in newborn stroke, advancing new treatments of this previously untreatable and~     disabling disease.~      Patient recruitment is currently underway at Alberta Children's Hospital. Application is~     currently underway to expand recruitment to Northern Alberta through the Glenrose~     Rehabilitation Hospital and Stollery Children's Hospital, to enable patients from Northern~     Alberta greater opportunity to participate as subjects in this study.~   "
181506|NCT01189045|"~     Little is known about how exercise can affect heart function in stroke survivors.~      This study will look at changes in cardiovascular fitness and function after 6 months of~     exercise. Volunteers will be tested before and after the program and again 2 months later to~     measure the effects on stroke risk factors, fitness level and flexibility of the arteries.~     Blood tests will measure cholesterol levels and other signs of inflammation.~      This study will help us better understand how exercise after stroke can improve heart~     function and heart health, and ultimately help in lowering future stroke risk.~   "
181507|NCT01189032|"~     Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in~     patients with dry eye, using a multicenter, randomized, double-blind, parallel group~     comparison study, and the optimal concentration is determined.~   "
181508|NCT01189019|"~     In this fifth year of anti-VEGF therapy for neovascular AMD, retinal physicians are~     collecting groups of patients who either do not or only partially respond to anti-VEGF~     therapy. This study will evaluate the efficacy and safety of 2mg ranibizumab specifically for~     patients with fibrovascular PEDs that have not resolved following at least 6 consecutive~     injections of ranibizumab or bevacizumab over the previous 12 months. The investigators~     hypothesize that the 2mg dose will be able to completely eliminate the persistent PEDS in~     these patients.~   "
181509|NCT01189006|"~     These results suggest that the DA neuroprotection provided by DM in the inflammation-related~     neurodegenerative models is not mediated through the NMDA receptor.~   "
181510|NCT01188993|"~     The purpose of this study is to assess the concordance of therapeutic changes proposed after~     an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly~     the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).~   "
181511|NCT01188980|"~     The purpose of this study is to determine if early Barrett's specialized intestinal~     metaplasia can be detected by measuring early increased blood supply of the esophageal~     tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in~     real time.~   "
181512|NCT01188967|"~     The purpose of this research study is to find out if an investigational drug, GSK598809 can~     help people who have very recently quit smoking; the investigators want to find out if~     continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To~     relapse means you fall back into smoking again after quitting. The investigators also want~     to find out if GSK598809 is safe to take without causing too many side effects.~   "
181513|NCT01188954|"~     A seroma is a collection of fluid other than pus or blood which forms through the division of~     numerous lymphatic channels, which normally drain the interstitial space under the skin.~     These channels become disrupted during surgical procedure and lead to seroma formation. This~     collection of fluid causes pressure in the local area, patient discomfort, and provides~     unfortunately an excellent culture medium for bacteria. Seroma development has been~     previously described in femoral vessel groin cannulation dissections after surgery.~     Conventional therapy is limited to draining the fluid, sometimes more than once, until there~     is full resolution of the seroma. If fluid collection recurs at the surgical site, sclerosant~     therapy with agents such as doxycycline. Doxycycline has been found to be a cost effective~     agent used as a sclerosant, which belongs to tetracycline class of antibiotics. The~     investigators hypothesize that prophylactic use of doxycycline at the site of femoral~     cannulation will prevent or minimize the area of seroma formation as compared to standard~     care of patients. The aim is driven towards limiting patient discomfort and visits to the~     clinic and to improve clinical care.~   "
181514|NCT01188941|"~     The purpose of this study is to test the effects of a health system navigator intervention on~     rates of linkage to human immunodeficiency virus (HIV) and tuberculosis (TB) care among newly~     diagnosed HIV-infected outpatients in Durban, South Africa. Subjects will be approached in~     the outpatient department and enrolled prior to an HIV test. Subjects will then be randomized~     to the navigator arm or the standard of care arm. Subjects in the navigator arm will receive~     scheduled phone and short message service (SMS) contacts throughout the follow-up period to~     help guide them through the HIV and TB care pathways. The navigator will provide personalized~     support to help subjects overcome barriers they may face along the way.~   "
181515|NCT01188928|"~     The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus~     Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when~     used individually as monotherapy in the topical suspension vehicle (betamethasone~     dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension~     vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris~     on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This~     comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol~     50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also~     establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of~     the body (trunk and/or limbs).~   "
181519|NCT01188876|"~     Pralatrexate is a type of antifolate drug which means is restrains the production of folic~     acid in the body. Folic acids are used by tumors to increase tumor cell growth and division.~     It is believed that reducing folic acid will hinder the rapid division of tumor cells, their~     growth and production. Carboplatin is an FDA approved chemotherapy drug for ovarian,~     fallopian tube and primary peritoneal cancer. Some antifolate drugs are used with other~     chemotherapy drugs to enhance cancer-fighting characteristics. It is believed that the study~     drug pralatrexate may improve the anti-tumor effect of carboplatin. In this research study we~     are looking for the highest dose of pralatrexate that can be given safely in combination with~     carboplatin.~   "
181520|NCT01188863|"~     This protocol is intended to compare the effects of both a solid (tablet) and liquid oral~     dosage form of LX4211 in subjects with type 2 diabetes mellitus.~   "
181521|NCT01188850|"~     DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages~     over traditional vaccines such as live attenuated virus and recombinant protein-based~     vaccines. DNA vaccines appear to be well tolerated in humans. Therefore, the investigators~     have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of~     both HPV subtypes 16 and 18. The investigators have chosen to deliver our candidate vaccines~     via electroporation (EP) using the CELLECTRA constant current device to deliver a small~     electric charge following intramuscular (IM) injection, since animal studies have shown that~     this delivery method increases the immune response to our DNA vaccine leading to a decrease~     in the size of tumors caused by HPV 16 and 18. In study HPV-001, the vaccine was given to~     subjects with a history of CIN 2 and 3 who had been previously treated by surgery. This study~     is proposed to vaccinate the same subjects with a fourth dose of the VGX-3100 to determine~     the safety and immune response.~   "
181522|NCT01188837|"~     Common medical therapies for knee osteoarthritis are patient education, drug and physical~     therapy, exercise and surgery. These modalities may offer improvement but drugs and surgery~     carry significant risk. Manipulative therapy for KOA gives pain relief and increased~     function. However, research suggests addition of manipulative and soft tissue therapy (to the~     entire kinetic chain: lumbosacral, sacroiliac, hip, knee, ankle and foot joints), may give a~     better outcome. Exercise therapy is considered an effective and standard care for KOA.~   "
181523|NCT01188824|"~     The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing~     down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with~     PAD in Taiwan.~   "
181524|NCT01188811|"~     The purpose of the study is to determine if lipoic acid can protect the brain and slow~     disability in secondary progressive multiple sclerosis.~   "
181525|NCT01188798|"~     The purpose of the study is to determine if participants who receive the GVHD prophylaxis~     medication pentostatin will have less severe hepatic toxicities than those receiving MTX. The~     study is estimated to have sufficient statistical power to ascertain at least a 20%~     improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin~     recipients.~   "
181526|NCT01188785|"~     Phase 0 - Open label, Single dose study of siG12D LODER in Patients with operable~     adenocarcinoma of the pancreas.~      The primary endpoint:~      To assess efficacy and local distribution of siRNA out of eight high dose siG12D LODERs in~     patients diagnosed with operable adenocarcinoma of the pancreas.~      The Secondary endpoint:~      Short term tolerability and safety assessment~      Phase I - This study is designed to investigate the safety of siG12D LODER (Local Drug~     EluteR) in patients diagnosed with adenocarcinoma of the pancreas.~      The primary endpoint:~      To asses efficacy of siG12D LODER and local distribution in non-operable patients by~     histopathology measurements, local distribution by RNA analysis.~      To define the dose-limiting toxicities (DLT)~      The Secondary endpoint~        1. To determine the recommended Phase II dose (RP2D)~        2. To define and maximum tolerated dose (MTD)~        3. In the event of surgery, assessment of siG12D LODER local distribution and efficacy will~          be based on histopathology measurements and RNA analysis.~        4. Progression free survival - only by long term follow-up~   "
181527|NCT01188772|"~     Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to~     receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated~     interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to~     an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA~     level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a~     2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower~     limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of~     PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.~      Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400~     mg plus PEG+RBV for 12 weeks.~   "
181528|NCT01188759|"~     This study aims to compare the safety, tolerability, and efficacy of voriconazole and~     anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17~     years with invasive aspergillosis.~   "
181529|NCT01188746|"~     The purpose of this study is look at how treatments for ascites affect quality of life. Your~     quality of life is the ability for you to enjoy the normal things you do. Ascites (pronounced~     as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is caused by~     cancer, also called malignancy.~      All people who participate in this study have ascites associated with cancer. Ascites can~     cause symptoms that make it difficult for the patient to do simple things. Patients with~     ascites often report:~      Abdominal swelling Difficulty walking. Difficulty breathing. Feeling full when eating.~     Clothes not fitting due to a swollen abdomen. Swelling in the legs. It is hoped that this~     catheter will relieve the symptoms of the ascites. The goal of the investigators study is to~     understand the quality of life before the procedure and after the procedure. Since the~     patient is having this procedure to make their symptoms better, the investigators want to~     hear from the patient of how the procedure has affected their quality of life.~   "
181530|NCT01188733|"~     Octreotide is used to control variceal bleeding. However, octreotide has to be given through~     the vein and is effective for less than two hours.~      In this study the investigators determined whether a long-acting preparation of octreotide~     (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal~     pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.~   "
181531|NCT01188720|"~     Preliminary findings from a trial in the investigators laboratory suggest that acute exercise~     may ameliorate deficits in sexual arousal associated with use of antidepressants. The goal of~     this project is to evaluate the real-world effectiveness of an exercise-based intervention~     for these side effects in a community-based sample. The investigators hypothesize that~     general exercise will help improve sexual functioning in women taking antidepressants, and~     that exercise immediately before sexual activity - that is, acute exercise - will have an~     additional beneficial effect above and beyond that of general exercise.~   "
181532|NCT01188707|"~     The Belinostat-Erlotinib trial is designed as an open, non randomized phase I / II trial to~     assess the efficacy and safety of Belinostat in combination with Erlotinib in patients with~     non-small cell lung cancer who are eligible for treatment with erlotinib.~   "
181533|NCT01188694|"~     Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a~     traumatic event and intense, persistent feelings of anxiety. There are several effective~     therapies for PTSD, but they are often time consuming. The investigators want to see if the~     investigators can shorten treatment time while keeping therapy effective by adding a~     medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific~     aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than~     placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those~     receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To~     examine whether medication plus psychotherapy helps with depression, trauma-related~     cognitions, and functioning.~   "
181534|NCT01188681|"~     The objective of the first part of the study is to determine a safe dose of TRU-016 that can~     be used in combination with bendamustine in patients with relapsed CLL. The objectives of the~     second part of the study are to compare the safety and efficacy of TRU-016 in combination~     with bendamustine to bendamustine alone in patients with relapsed CLL.~   "
181535|NCT01188668|"~     The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine~     Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy~     adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine~     SR and Aripiprazole when coadministered to healthy adult subjects.~   "
181536|NCT01188655|"~     This observational study will be a documentation of the prescribing and administration~     practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real~     life setting.~   "
181537|NCT01188642|"~     Obesity is now becoming significantly prevalent of an environment characterized by easily~     available calorics foods combined with sedentary lifestyles. Moreover, it has been~     demonstrated that obesity is associated with metabolic complications such as disturbed~     adipocytokines, hormones secreted by adipose tissue. Given these observations, the purpose of~     this study is to assess the effects of a lifestyle intervention focused on various physical~     activities and nutrition education on adipocytokines hormones, in severely obese teenagers.~   "
181538|NCT01188629|"~     Interactive telephony technologies offer a potentially highly effective, patient-centered~     communication modality by guiding parents at home through interactive discussions that can~     gather information and actively reinforce recommendations and treatments. Interactive~     telephony systems are particularly well suited for use in vulnerable populations since access~     to the telephone is nearly universal, and the system does not rely on reading printed text.~     The investigators propose to develop and evaluate an integrated patient-centered health~     information system, the Personal Health Partner (PHP). The PHP will use fully automated,~     interactive, conversations to gather personal health data and counsel parents before~     scheduled visits, exchange that data with the child's primary care clinician via the~     electronic health record (EHR), and offer personalized follow-up assessment and counseling~     after visits. The information technology-based approach to be evaluated in this project will~     link parents and children outside the clinical setting with their primary care center and~     will offer comprehensive assessments AND counseling to reinforce and support parental~     behavior change.~   "
181539|NCT01188616|"~     The goal of this exploratory/ developmental study is to develop and evaluate an integrated~     information system, Healthy Eating and Activity Today (HEAT), for promoting self-care in~     overweight children. HEAT is comprised of two components: 1)Telephone Linked Care-HEAT~     (TLC-HEAT), a self-care intervention delivered at home through totally automated telephone~     conversations; and 2) Primary Care-HEAT (PC-HEAT), a primary care intervention linked with~     TLC-HEAT and delivered through an electronic health record (EHR). The HEAT system will guide~     children in the early stages of overweight, i.e., children with Body Mass Index (BMI) 0-3 BMI~     points above the 95th percentile for age and gender, toward healthy weight management and~     assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.~   "
181540|NCT01188603|"~     This trial examines the way flibanserin is metabolized in postmenopausal women with~     Hypoactive Sexual Desire Disorder.~   "
181541|NCT01188590|"~     The purpose for the investigators study is to investigate the severity and incidence of~     respiratory insufficiency using transcutaneous carbon dioxide (TcPCO2) monitoring as an~     adjunct to the current standard of care for early detection of inadequate ventilation in~     post-operative surgical in-patients undergoing cardiac surgery after discharge from intensive~     care unit (ICU) or post anesthesia recovery unit (PACU).~   "
181542|NCT01188577|"~     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine~     Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled~     epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous~     epinephrine, in healthy male and female adult volunteers. The current study is designed for a~     more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated,~     under augmented dose conditions.~   "
181543|NCT01188564|"~     This study is being conducted to confirm the efficacy, safety, and immunogenicity of~     recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of~     acute angioedema attacks in Hereditary Angioedema (HAE) patients.~   "
181544|NCT01188551|"~     This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following~     anesthesia induction in patients undergoing myringotomy and placement of pressure~     equalization (PE) tubes in providing analgesia and smoothing emergence from general~     anesthesia.~   "
181545|NCT01188538|"~     The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene~     0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.~   "
181547|NCT01188512|"~     The purpose of this study is to evaluate the safety and immunogenicity of a new live~     attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating,~     placebo-controlled study on a genetically modified B. pertussis strain given as a single~     intranasal dose to healthy adult male volunteers.~      Effective vaccines are needed to protect young infants (from 0 to 6 months, today the most~     vulnerable age group), preferably after a single administration very early in life. The~     successful outcome of this project would constitute an important milestone towards nasal~     vaccination of infants, possibly at birth with a novel, single-dose pertussis vaccine. Our~     ultimate aim is to protect infants in the most vulnerable age group, before the regular~     vaccination schedule using already available vaccines is applied. The ultimate aim is thus~     not to replace current vaccination schedules with available vaccines, but to add a first~     nasal vaccination to protect very early in life.~   "
181548|NCT01188499|"~     This is a dose escalation safety study of birinapant (TL32711) in combination with~     chemotherapy in subjects with advanced or metastatic solid tumors.~   "
181549|NCT01188486|"~     The stereotactic body radiation therapy (SBRT) procedure is an emerging alternative to the~     standard treatment for early stage non-small cell lung cancer (NSCLC), typically lobectomy~     with lymphadenectomy. This procedure (lobectomy) does not fulfill the medical need as many~     patients are poor operative candidates or decline surgery.~      This study assesses the feasibility of stereotactic body radiation therapy (SBRT) as a tool~     to produce therapeutically useful computed tomography (CT) scans, using standard~     water-soluble iodinated compounds as the contrast agents.~   "
181550|NCT01188473|"~     Status asthmaticus is recognized as a common cause of morbidity in children in the United~     States. In recent years, hospitalization rates have reached an all time high. This study will~     evaluate the safety, tolerability and clinical benefit of adding Noninvasive Positive~     Pressure Ventilation (NPPV)to regular care in children with moderate to moderately severe~     status asthmaticus.~   "
181551|NCT01188460|"~     This study will test the impact of a cognitive-behavioural self-management approach for the~     management of insomnia among patients with chronic pain. This self-management approach~     consists of a manual describing cognitive behavioural techniques for the management of~     insomnia. In terms of primary outcomes, it is anticipated that there would be improvements in~     sleep-related dimensions such as sleep quality, sleep efficiency, and night-time awakenings~     in the sample group receiving a copy of the self-help manual intervention to be implemented~     by participants in their home (intervention group), relative to the group receiving treatment~     as usual (control group). In terms of secondary outcomes, it is anticipated that the~     intervention group will show improvements in mood, fatigue, pain severity, and pain-related~     disability relative to the control group. The tertiary outcome variable of pre-sleep arousal~     is anticipated to have a moderating or mediating relationship with the sleep variables~     investigated.~   "
181552|NCT01188447|"~     The goal of this cohort study is to evaluate the safety and potential impact of an active~     strategy that allows paramedics to assess very low-risk trauma patients with the Canadian~     C-Spine Rule (CCR) and transport them to the Emergency Department without immobilization. The~     specific objectives of the study are to determine safety, determine the clinical impact and~     evaluate performance.~   "
181553|NCT01188434|"~     This Research Plan proposes Stage 1 Research integrating evidence based practices to address~     the needs of mothers referred to child welfare for substance abuse. Mothers with a history of~     methamphetamine abuse and child neglect will be recruited. Using an intensive community based~     treatment, mothers will receive substance abuse treatment combined with parenting skills~     training and psychosocial support for basic needs (e.g., housing, employment). This project~     will include a feasibility study (n = 5), followed by a small randomized pilot (n = 24) to~     examine the efficacy of the Integrated Treatment for Substance Abuse and Neglect compared to~     treatment as usual, with a population of substance abusing neglectful mothers referred~     through the Department of Child Welfare.~   "
181554|NCT01188421|"~     This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A~     randomized, double blind clinical trial comparing the efficacy and safety of tramadol to~     clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be~     conducted. Opioid dependent participants will be treated on a residential unit. The primary~     outcome measure is opioid withdrawal symptoms.~   "
181555|NCT01188408|"~     LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc.~     Docetaxel (currently marketed as Taxotere) is an anti-microtubular network agent and is one~     of the most active agents in the treatment of metastatic castrate resistant prostate cancer~     (CRPC) and other variety of cancers. Taxotere has poor solubility and is designed to be~     administered with Tween 80 in ethanol. This vehicle causes acute hypersensitivity reaction.~     By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and~     comparable therapeutic efficacy in pre-clinical study. The clinical evidence obtained from~     the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose~     to induce greater effectiveness of LE-DT. The current Phase II study is designed to~     accomplish the following objectives:~        1. Assess the antitumor effect indicator serum prostate specific antigen (PSA) following~          the intravenous (IV) administration of 110 mg/m2 LE-DT every three weeks in patients~          with metastatic castrate resistant prostate cancer~        2. To evaluate the measurable soft tissue disease response using the response evaluation~          criteria in solid tumor (RECIST) methodology~        3. To evaluate the progression-free survival (PFS) and overall survival (OS)~        4. To correlate PSA expression with tumor response~        5. To evaluate the safety of LE-DT at 110 mg/m2 level, in particular peripheral neuropathy,~          water retention as well as myelotoxicity~        6. To evaluate the quality of life (QOL)~   "
181556|NCT01188395|"~     The aim of this study is to explore relation between the comorbidity of different bipolar~     disorders with alcoholism and neuropsychiatric function and candidate genes. The~     investigators plan to establish genetic validity for this subtype of alcoholism. In addition,~     by comparing this subtyped alcoholism to normal control, the investigators plan to examine~     the genetic validity of such comorbidity. The investigators plan to find specific clinical~     characteristic from neuropsychiatric aspects of such subtype for future early diagnosis,~     prediction and prevention.~   "
182624|NCT01174420|"~     The aim of this prospective randomized study is to investigate the efficacy and safety of~     trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in~     patients with medically uncontrolled open angle glaucoma.~   "
181557|NCT01188382|"~     Objective. The intracranial pressure and cerebrospinal outflow resistance are essential~     parameters to describe the cerebrospinal fluid dynamic system. Outflow resistance effects~     intracranial pressure, pulse amplitudes, cerebrospinal fluid absorption as well as the~     compliance of the system. The objective of this study was to determine the reference values~     in the elderly.~      Methods. Elderly people (60-82 years), considering themselves healthy, were recruited through~     an ad in the local paper. All were evaluated with a 3 Tesla magnetic resonance imaging~     apparatus. Subjects were eligible if they did not have any psychiatric or neurological~     disorder or signs of advanced atherosclerotic disease. Intracranial pressure and outflow~     resistance were determined by a constant pressure infusion method with the patient in the~     supine position. The study population consisted of 40 subjects (mean age 70 years; 23 women).~   "
181558|NCT01188369|"~     This is a clinical, randomised, double-blinded study in which patients eligible for aortic~     valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4~     hours prior to surgery and until the end of surgery.~   "
181559|NCT01188356|"~     The purpose of this study is to evaluate the incidence and evolution over-time of~     co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2~     years follow-up.~   "
181560|NCT01188343|"~     This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus~     vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at~     separate visits 6 weeks apart in toddlers aged 12 to 18 months.~      Primary objective:~        -  To demonstrate the non-inferiority of the antibody responses in terms of seroconversion~          of the concomitant administration of JE-CV and MMR compared to the antibody responses~          after the single administration of JE-CV and MMR vaccine.~      Secondary objectives:~        -  To describe the immune response to JE CV and MMR before and after one dose of JE CV and~          MMR vaccine, respectively.~        -  To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a~          6-week interval and the safety of the concomitant administration of JE-CV and MMR~          vaccine in all subjects up to 6 months after last vaccination.~   "
181561|NCT01188330|"~     Acute myeloid leukaemia (AML) is a disease of the elderly, with a median age at diagnosis of~     65. A poor outcome in this population has been well established, with very short overall~     survival (OS) and disease free survival (DFS).There are numerous bad prognostic factors~     related to the disease itself or to the patient's medical condition.~      This study will evaluate the impact of a Comprehensive Geriatric assessment (CGA) performed~     at diagnosis with planned interventions according to disabilities and monthly follow-up by a~     nurse practitioner during 6 months on functional status of older cancer patients treated for~     Acute myeloid leukaemia. Functional status will be assessed with the Lawson Instrumental~     Activities of Daily Living (IADL) scale at diagnosis and 6 months after randomisation.~   "
181562|NCT01188317|"~     This randomized, double-blind, placebo-controlled, parallel group study will investigate the~     safety and tolerability, and the effect of aleglitazar in combination with ibuprofen on renal~     function, renin-angiotensin system and pharmacokinetics in healthy volunteers. Volunteers~     will be randomized to receive daily doses of aleglitazar or placebo in combination with~     ibuprofen. The anticipated time on study drug is 5 weeks.~   "
181563|NCT01188304|"~     This randomized, double-blind, placebo-controlled, parallel group study will investigate the~     safety and tolerability, and the effect of aleglitazar in combination with aspirin on renal~     function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers~     will be randomized to receive daily doses of aleglitazar or placebo in combination with~     aspirin. The anticipated time on study drug is 5 weeks.~   "
181564|NCT01188291|"~     The purpose of this study was to measure the retinal nerve fiber layer (RNFL) thickness in~     eyes of Obstructive Sleep Apnea/hypopnea syndrome (OSAHS) using optical coherence tomography~     (OCT), and assess whether it is decreased. The investigators then compared the results with~     healthy subjects database of RNFL thickness from another retrospective study.~   "
181565|NCT01188278|"~     The purpose of this study is to determine predictive value of Hammersmith score on Complete~     Cytogenetic Response (CCyR).~   "
181566|NCT01188265|"~     Dextromethorphan has been reported affording neuroprotection on dopaminergic neurons and~     having protective effect against inflammation-related neuron damage. These anti-inflammatory~     and neuroprotective effects of dextromethorphan would suggest potential clinical benefits of~     dextromethorphan add-on therapy to valproate for bipolar disorder patients. This hypothesis~     was based on the findings that the mood stabilizers have been reported to be neuroprotective~     through the release of neurotrophic factors such as GDNF from astroglia. Thus, the~     combination treatment of mood stabilizers and dextromethorphan might improve the therapeutic~     efficacy for bipolar disorder patients.~   "
181567|NCT01188252|"~     Clinical study to determine safety, tolerability, to measure how the drug is metabolized by~     the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent 3~     days on / 4 days off schedule to patients with advanced malignancies~   "
181568|NCT01188239|"~     The study's major aim is to investigate the ability of a commercial Electronic Nicotine~     Delivery Device (E-Cigarette) loaded with low dose nicotine to induce long-term smoking~     reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes~     in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette~     and smoking is safe. The study will monitor smoking reduction/abstinence effects, changes in~     withdrawal symptoms, and adverse events of a currently marketed device in Italy (Categoria~     electronic cigarette) using initially for 6 weeks ORIGINAL 7.4 mg nicotine cartridges~     followed by a further 6 weeks of CATEGORIA 5.2 mg nicotine cartridges. The primary~     hypothesis is that the E-Cigarette used in a structured protocol is a safe device that allows~     smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and~     cravings.~   "
181589|NCT01187966|"~     The purpose of this study is to evaluate the efficacy and safety of two doses of safinamide~     (50 and 100 mg/day, p.o.), compared to placebo, as add-on therapy in patients with idiopathic~     Parkinson's disease with motor fluctuations who are currently receiving a stable dose of~     levodopa.~   "
181622|NCT01187537|"~     The purpose of this study is to compare the effectiveness of three analgesia techniques on~     pain relief and functional recovery after knee replacement: continuous femoral nerve block vs~     single-injection femoral nerve block with intravenous patient controlled analgesia vs~     intravenous patient controlled analgesia.~   "
181569|NCT01188226|"~     The majority of teeth utilized in the fabrication of conventional complete dentures are made~     of acrylic resins. These acrylic teeth provide increased bond strength to the denture base~     and are much easier to adjust for correct denture occlusion compared to teeth made of harder~     materials, such as porcelain. However, the acrylic teeth will wear faster than the porcelain~     teeth, leading to alterations in how the teeth contact each other if the denture is not~     replaced periodically (typically every 5-8 years). With the increase in biting and chewing~     forces that can be achieved during function with dentures supported by dental implants, the~     rate of tooth wear may be increased, leading to more frequent need for replacement of the~     prosthesis. Acrylic teeth made of nano hybrid composite material (NHC) potentially offer~     greater wear resistance and aesthetic characteristics. The NHC teeth employ a wide range of~     fillers, including highly cross-linked organic macrofillers, high-density inorganic~     microfillers and silanized silica based nanofillers. The macrofillers are, to a large part,~     responsible for the adequate strength and color-stability of the teeth, whereas the~     microfillers improve the wear resistance. The nanofillers offer fundamentally different~     optical behaviour from those of larger fillers, improving light reflection without lowering~     the translucency. This offers additional opportunities in the development of composite teeth,~     which have to exhibit lifelike aesthetics and translucency. These teeth made of~     nano-particles and hybrid composites can be made with two different techniques, one where the~     materials are pressed together and another using an injection technique. The injection method~     has been found to have better aesthetic results, but resistance to wear in clinical use has~     not been established.~      The purpose of this study is to evaluate the wear characteristics of new resin denture teeth~     (nano particles - hybrid composite) made by an injection technique. Twenty-four edentulous~     subjects will be enrolled who have completed implant placement for mandibular implant~     overdentures opposing a maxillary complete denture or implant overdenture, or patients that~     have previously received these dentures and are interested in having new dentures. Both~     maxillary and mandibular dentures will be fabricated using injection molded nano-hybrid~     composite denture teeth. The wear of denture teeth will be evaluated using stereophotographic~     recordings at baseline, 6, 12, 18 and 24 months after denture treatment.~   "
181570|NCT01188213|"~     The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in~     treating patients with knee OA.~   "
181571|NCT01188200|"~     The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients~     with type 2 diabetes.~   "
181572|NCT01188187|"~     This Phase 3 study has been designed to confirm that adding custirsen to standard first-line~     docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes~     compared to standard first-line docetaxel/prednisone treatment alone. This will be a~     randomized, open-label, multicenter, international trial. Treatment will consist of~     docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients~     will be randomized. Patients will be randomly assigned with equal probability to the two~     arms.~   "
181573|NCT01188174|"~     The present trial will establish a prospective sequential Allogeneic Stem Cell~     Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced~     Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to~     which future innovative strategies can be compared.~   "
181574|NCT01188161|"~     Subjects will be secured and rotated in a whole body gyroscope, similar to a flight trainer~     for astronauts. The rotations will be in many directions and the speed will be at 90 deg/sec.~     The effects of this rotation on the ability to stand upright will be measured.~   "
181575|NCT01188148|"~     All participants should fulfill the following criteria: aged between 18 and 65 years old, and~     of domestic Han descendants. Participants will be randomly assigned to either the (1)~     pharmacotherapy (valproate add-on memantine) group; (2) pharmacotherapy (valproate add-on~     memantine) plus Cognitive Behavior Group Therapy (CBGT) group; (3) valproate add-on placebo~     plus CBGT group, or (4) valproate add-on placebo only group. A total of 240-320 individuals~     (60-80 participants per group) will be recruited for this study. For each CBGT group,~     12-weekly sessions are scheduled according to patients' preference. The investigators will~     attempt to understand the effects of pharmaceutical drugs for mood stabilizers add-on~     neuro-protective drugs, pharmacotherapy with CBGT, mood stabilizer with CBGT, and the use of~     only traditional mood stabilizers in the treatment of BP II. Comparisons will be made for~     each type of treatment and possible mechanisms will be examined regarding the pharmacotherapy~     and CBGT for bipolar disorder patients.~   "
181576|NCT01188135|"~     Antidepressants are the most frequently prescribed class of psycho¬tropic medications and the~     most common treatment for depression and anxiety disorders—yet patient adherence is poor and~     is widely viewed as contributing to reduced effectiveness. However, traditionally-delivered~     adherence promotion programs are complex, staff-intensive, and costly—barriers to wider~     adoption, implementation, and maintenance of these programs in real-world settings. Our aim~     is to carry out a trial of a low-cost, IT-enabled Antidepressants adherence program,~     specifically a direct-to-patient, automated telephone interactive voice recognition (IVR)~     intervention to boost patient Antidepressants persistence. We will conduct a randomized~     clinical trial enrolling at least 6,000 Kaiser Permanente NW Region health plan members ages~     21 to 75, who had recently started on Antidepressants medications for depression and/or~     anxiety diagnoses. Participants will be randomized one of four arms;1. a no contact control~     arm, 2. a treatment as usual (TAU) control condition 3. to TAU plus the IVR automated~     telephone program and 4. a TAU plus the IVR automated telephone program plus receipt of~     psycho-education materials about antidepression medication use. Recruitment will continue for~     up to 18 months, with periodic participant-level follow-up assessment for the intervention~     participants for 40 weeks. The IVR intervention portion of the program will deliver reminder~     and/or tardy calls timed to projected Antidepressants refill dates. The intervention also~     optionally offers brief psycho-education, or transfer to a live pharmacist or the Kaiser mail~     refill pharmacy. The primary outcome will be the Estimated Level of Persistence with Therapy~     (continued us of Antidepressants medications). This will be based on prescription refill data~     abstracted from the Kaiser's electronic medical record (EMR). We hypothesize that~     participants in the IVR + psycho-education materials study arm will have a significantly~     higher rate of Antidepressants persistence than those in the TAU control condition ons only~     IRV call arms. We will also conduct cost-effectiveness analyses to assess the value-for-money~     (cost per depression free day gained, and cost per quality adjusted life year gained) of the~     IVR technology compared to TAU. Costs will include IVR development and implementation as well~     as EMR-derived healthcare utilization data (visits, medications, etc.), augmented with~     participant report of out-of-plan services.~   "
181577|NCT01188122|"~     Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended~     to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2)~     in upper airways of mechanically ventilated patients. Optimal ETT cuff inflation will lead to~     a reduction of complication rate related to mechanical ventilation procedure.~      This study was design in order to evaluate the feasibility of using the AnapnoGuard system.~   "
181578|NCT01188109|"~     The purpose of this study is to investigate if the investigators can use a specific marker in~     the pancreatic tumor itself to determine which patients will benefit from receiving~     combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a~     pancreatic cancer.~      The investigators will also investigate if there is any benefit to receiving both~     chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the~     tumor.~   "
181590|NCT01187953|"~     This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets~     administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as~     immunosuppression for the prevention of organ rejection in newly transplanted adult kidney~     transplant recipients. Patients will be treated for a 12 month study period followed by a 12~     month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically~     similar to Prograf Capsules in the prevention of acute rejection.~   "
181579|NCT01188096|"~     This study is for patients up to 21 years of age who have a tumor called a low grade glioma~     of the central nervous system (brain and spinal cord). The tumor has grown despite attempts~     to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that~     tend to grow slowly and could be cured if every bit of the tumor were surgically removed.~     These tumors are called Grade I or II astrocytomas.~      These tumors often grow in parts of the brain that prevent total removal without devastating~     neurologic complications or death. Although some low grade gliomas never grow, most will and~     are treated with either chemotherapy or radiation. There is good data showing that the growth~     of most low grade gliomas can be controlled with chemotherapy or radiation. However, some low~     grade gliomas in children and young adults grow despite these treatments. Poly-ICLC is a new~     drug that has been used safely in children and adults with different types of brain tumors.~     Earlier studies showed that this drug worked better for children and young adults with low~     grade gliomas than for children with more aggressive brain tumors. The main purpose of this~     study is to use Poly-ICLC treatment in a larger number of patients to see how well it works~     and how many side effects occur.~      As Poly-ICLC is not FDA approved, this study is authorized to use it under IND# 43984, held~     by Oncovir.~      Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments~     will be given in the clinic so allergic or other severe reactions, if any, can be monitored.~     If subjects tolerate the injections and don't have a severe reaction, then the rest of the~     injections will be given at home. Subjects/caregivers will be trained to give injections.~      Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2 years~     if their tumor shrinks in response to the injections, if study doctors think it is safe, if~     subjects want to remain on treatment, and if Poly-ICLC is available.~      Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study,~     and at higher doses. Frequently seen side effects include irritation of the skin at the~     injection site and mild flu-like symptoms. These are usually relieved or avoided by use of~     over-the-counter medicines like acetaminophen (Tylenol).~      Funding Source: FDA OOPD~   "
181580|NCT01188083|"~     Primary Objectives:~        1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic~          steatosis in overweight children who have a baseline high fructose consumption and~          hepatic steatosis.~        2. To determine if a 4 week reduction of dietary fructose improves fasting plasma~          triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as~          well as post-prandial levels in response to a high fructose meal.~        3. To determine if a 4 week reduction of dietary fructose improves markers of oxidative~          stress.~      Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose~     beverages administered over 4 weeks.~   "
181581|NCT01188070|"~     More and more family members are providing care to their loved ones with prolonged and~     progressive illnesses. Chronic intense caregiving represents a situation of chronic stress,~     which takes a toll on one's mental and physical health including an increased risk for the~     development or worsening of heart disease. Identification of effective self-care~     interventions for family caregivers is warranted to improve their emotional wellbeing and~     minimize the harmful effects of chronic stress on the heart. This Program Project Grant aims~     to promote health and reduce cardiovascular risk in family caregivers (FCG) of persons with~     chronic illness. In two studies the investigators will test two interventions,~     psycho-education(ED) and physical exercise(EX), individually and in combination. The first~     study will target FCG of African American dementia patients; the second will focus on FCG of~     heart failure patients. Parallel designs, interventions and measures will create synergy as~     will integration of all data management and analyses within a Bio-behavioral Science and~     Measures Core. This Core will also provide high level guidance and interpretation of model~     testing resulting from analysis of the common data set. The combined de-identified data set~     will allow for elucidating the biological mechanisms of stress-induced cardiovascular risk,~     further developing the model, and stimulating future research, while the shared core support~     will provide substantial efficiency; neither could be achieved outside of a Program Project~     approach. These collective efforts will generate important data whereby future care can~     significantly enhance the lives of FCG and minimize their risk of cardiovascular disease, the~     number one cause of disability and death in the United States.~      We hypothesize that FCGs who receive the combined PSYCHED+EX intervention will have better~     psychological functioning (lower levels of depressive symptoms, anxiety, and caregiver burden~     and higher levels of flourishing), behavioral outcomes (improved sleep quality and greater~     physical function), cardiovascular risk measures (improved resting heart rate, blood~     pressure, heart rate recovery, oxygen consumption, lipids, glucose, and inflammatory~     markers), neuroendocrine function (salivary cortisol) and overall health outcomes (improved~     function, muscle strength, and endurance) compared to psycho-education and usual~     care-attention control from baseline to six months later mediated by improvements in process~     outcomes (lower perceived stress and higher self-efficacy).~   "
181582|NCT01188057|"~     This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam~     Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2~     mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs~     Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult~     volunteers administered under non-fasting conditions.~   "
181583|NCT01188044|"~     One way to assess impacts of nutrition supplements to health is to measure physical activity.~     Physical activity can be measured with small devices called accelerometers. Before they can~     be used, the devices need to be validated in the population in question. Objectives of this~     study are to test accelerometers in field conditions and validate their use in 16-18 months~     old Malawian toddlers. This study does not have a pre-set hypothesis.~   "
181584|NCT01188031|"~     This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam~     Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2~     mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs~     Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult~     volunteers administered under fasting conditions.~   "
181585|NCT01188018|"~     The purpose of this study is to determine, among a sample of general adult smokers, the~     effectiveness of three different counseling interventions for motivating quit attempts among~     smokers not yet ready to quit.~   "
181586|NCT01188005|"~     Obstructive Sleep Apnea Syndrome (OSAS) is associated with elevated plasma levels of IL-6 and~     TNF-α, which cannot be accounted for by obesity (Vgontzas et al Sleep Med Rev 2005;9:211-24,~     Ciftci et al Cytokine 2004;28:87-91].~      Obstructive apneas-hypopneas are accompanied by strenuous diaphragmatic contractions before~     the ensuing arousals and re-establishment of airway patency. We have shown that strenuous~     diaphragmatic contractions induced by resistive loading lead to elevated plasma levels of~     IL-6, TNF-α, and IL-1β (Vassi-lakopoulos et al AJRCCM 2002;166:1572-8) with concomitant~     up-regulation of the cytokines within the diaphragmatic myofibers (Vassilakopoulos et al~     AJRCCM 2004;170:154-61).~      OSAS patients exhibit frequent episodes of hypoxemia during the night. Loaded breathing is a~     form exercise for the respiratory muscles, and both acute and chronic hypoxia lead to an~     augmented plasma IL-6 response to exercise compared to normoxia (Lundby et al Eur J Appl~     Physiol 2004;91:88-93).~      In OSAS, monocytes have oxidative stress (Dyugovskaya et al AJRCCM 2002;165:934-9) and~     produce more cytokines (TNF-α) in vitro (Minoguchi et al Chest 204;126:1473-9).~      Hypothesis #1: plasma levels of IL-6 and TNF-α are increased during the night in OSAS~     patients secondary to the intermittent strenuous diaphragmatic contractions and the episodes~     of hypoxia-reoxygenation associated with the obstructive apneas-hypopneas.~      Hypothesis #2: monocytes from sleep apnea patients, exhibit augmented intracellular~     expression of IL-6 and TNF-α during the night.~      Hypothesis #3: Oxidative stress is a stimulus for cytokine upregulation in OSAS.~   "
181591|NCT01187940|"~     When a clinician gives an autism spectrum disorder (ASD) diagnosis they hope this will be~     helpful to the person receiving it and their family. In reality children with an ASD describe~     few benefits to receiving this diagnosis - they often report feeling confused and stigmatised~     by it. Parents can also struggle to understand their child's diagnosis and report needing~     greater support from professionals in this respect (Midence & O'neill, 1999; Osborne & Reed,~     2008).~      Little is known about how to help children and families integrate their ASC 'label' in a~     positive way. Whilst there is anecdotal evidence that psychoeducation after diagnosis can~     help, there has been no formal evaluation of this approach and no evidence-based programmes~     of this type are available. In the current study the investigators aim to test empirically a~     psychoeducational programme for children with an ASD ('PEGASUS'), using a randomised~     controlled design. The investigators aim to evaluate whether this psychological and~     educational intervention impacts positively upon understanding of ASC, self-esteem,~     functional adaption, well-being and family functioning.~   "
181592|NCT01187927|"~     This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in~     Japanese female subjects under conditions of actual use.~   "
181593|NCT01187914|"~     The purpose of this study is to evaluate the impact of pre-ablation fibrosis on scar~     formation in the left atrium of the heart. This will be assessed by delayed enhancement~     magnetic resonance imaging and will be looked at in patients who have undergone successful~     open irrigated cooled-tipped radio-frequency ablation of paroxysmal atrial fibrillation.~     Follow-up after ablation will be for 12 months.~   "
181594|NCT01187901|"~     The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial~     if the combination of sulindac and erlotinib causes a significant regression of duodenal and~     colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP)~     patients.~   "
181595|NCT01187888|"~     The purpose of this study is to determine whether rasagiline is effective in the treatment of~     Progressive Supranuclear Palsy (PSP), a rapidly progressing disease with a symptomatology~     similar to Parkinson's Disease. The major aim of this study is the limitation or halting of~     the process of neurodegeneration and influence postural instability.~   "
181596|NCT01187875|"~     Dietary fiber consumption may contribute to weight regulation by improving satiety. In an~     earlier study the investigators found that a muffin containing resistant starch was more~     effective than other fibers in altering satiety. The objective of this study is to determine~     if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant~     starches is more effective than either alone in enhancing satiety.~   "
181597|NCT01187862|"~     The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called~     Basel cocktail) can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9,~     CYP2C19, CYP2D6, CYP2E1 and CYP3A4.~   "
181598|NCT01187849|"~     The purpose of this study is to evaluate if a treatment with metformin compared to placebo~     reduces metabolic side-effects in patients with glucocorticoid treatment over three months~     time.~   "
181599|NCT01187836|"~     In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with~     heart failure to learn about the effects of TRV120027. The results of this study will help~     choose the proper range of TRV120027 doses to use in future research studies involving~     patients with acute decompensated heart failure.~   "
181600|NCT01187823|"~     The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV~     Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep~     apnea.~   "
181601|NCT01187810|"~     The purposee of this study is to determine the safety and dosing of Fenretinide when given~     continuously for 5 days, every 3 weeks, in pediatric patients with recurrent and/or resistant~     acute lymphoblastic leukemia (ALL), acute myelogenous leukemia (AML), and non-Hodgkin's~     lymphoma (NHL).~   "
181602|NCT01187797|"~     The purpose of this study is to evaluate the effects of a short-term emotional stimulation on~     the mood of healthy persons.~   "
181603|NCT01187784|"~     Many children and adolescents with autism spectrum disorder (ASD) experience high levels of~     anxiety which can further inhibit their ability to master developmental tasks such as~     succeeding in school and developing and maintaining friendships. Despite the need for~     effective treatments for children with ASD and anxiety, there have been few studies that have~     addressed this issue. Recently, preliminary evidence has supported the use of~     cognitive-behavioral therapy (CBT) to treat anxiety disorders in children with ASD.~      This study will utilize a CBT treatment program called Coping Cat. Coping Cat has been found~     to be one of the most effective treatments for typically developing children with anxiety and~     has also been shown to be effective for treating anxiety in children with other disorders~     such as physical impairments, selective mutism, and Attention Deficit Hyperactivity Disorder.~     The investigators goal is to demonstrate that Coping Cat is an effective treatment for~     children with ASD and anxiety. Finding effective treatments for children with ASD and anxiety~     could increase adaptive social relationships, decrease stress among families, and prevent the~     maintenance of anxiety into adulthood.~   "
181604|NCT01187771|"~     The purpose of this study is to assess the feasibility of conducting a comparative~     effectiveness study comparing a medical versus surgical approach to the initial management of~     obstructive sleep apnea (OSA) in the setting of obesity.~   "
181605|NCT01187758|"~     This study aims to implement judicious antibiotic prescription habits to primary care~     pediatricians using a multifacet educational intervention and assess two main outcomes: 1)~     Direct outcome - prescription rates of the physicians. 2)Indirect outcome - carriage of~     antibiotic resistant bacteria by the treated population, specifically nasopharyngeal S.~     pneumoniae, nasal S. aureus and rectal E.coli.~   "
181606|NCT01187745|"~     Patients suspected of having a kidney stone are usually evaluated by computed tomography (CT)~     scan. The investigators hypothesize that ultrasound (U/S) should be sufficient to evaluate~     kidneys for suspected renal stones.~   "
181607|NCT01187732|"~     The purpose of this study is to compare the traditional bed bath with 'washing without water'~     on~        -  1) effects on skin integrity~        -  2) patient and nurse satisfaction and 3) costs. In a cluster randomized trial we will~          randomize 50 nursing home wards (576 patients) to 'washing without water' or traditional~          bed baths. Bathing regimens are continued for six weeks.~      Whereas effects on skin damage are not likely to be specific for setting, these results can~     be generalized to other patient groups.~   "
181608|NCT01187719|"~     The primary objective of this two-phase trial is as follows:~        -  To determine the elimination half-life of NVP in HIV positive pregnant women receiving~          it as a single dose in labour in addition to the ZDV and 3TC with or without seven days~          phenytoin (pilot PK phase)~        -  To determine NVP resistance in HIV positive pregnant women receiving it as a single dose~          in labour in addition to ZDV and 3TC with or without seven days phenytoin (main trial~          phase)~      The secondary objectives of this two-phase trial are as follows:~        -  To determine the safety of single dose nevirapine with seven days phenytoin as a part of~          ARV prophylaxis for PMTCT vs. single dose of nevirapine without phenytoin as a part of~          ARV prophylaxis for PMTCT~        -  To determine the HIV status of the infant~        -  To determine the safety of the ARV prophylaxis for PMTCT with seven days of phenytoin on~          the newborn~      Hypothesis: phenytoin reduces the elimination half life of SD NVP and thereby decreases~     development of resistance to NVP in HIV positive pregnant Tanzanian and Zambian women.~   "
181609|NCT01187706|"~     To compare quality of life and it's related factors between gynecological cancer survivor and~     healthy controls.~   "
181610|NCT01187693|"~     People with anatomical leg length discrepancy (LLD) commonly presented excessive subtalar~     pronation of the long leg compared to their short leg in order to equalize leg length.~     Although such compensation may decrease the stress in the pelvis and/or low back region, the~     pronated foot may lead to excessive stress loading onto the ankle or foot, resulting in~     musculoskeletal injuries. Clinically, the pronated foot has been effectively controlled using~     functional orthoses with proper posting by adjusting the subtalar joint in the neutral~     position. But for people with compensatory pronated foot resulted from anatomical LLD, to~     control excessive pronation of the long leg would exaggerate their asymmetry in leg length.~     Instead, the pronated foot can be controlled simply by adjusting the length of the short leg.~     However, there is limited evidence of such intervention in previous literature. The purpose~     of this research project is going to determine the effect of leg length adjustment on~     pronation control in people with anatomical LLD. According to this purpose, 5 study~     objectives will be developed: 1) to examine the validity and reliability of LLD measurement~     using a hand-held laser distance meter, 2) to compare the foot types before and after leg~     length adjustment, 3) to compare the kinetic variables before and after leg length adjustment~     during quiet stance, 4) to compare the kinetic variables before and after leg length~     adjustment during level walking, and 5) to compare symptoms and functional levels related to~     low back pain (LBP) before and after leg length adjustment.~      The present research project will be designed as a convenience sampling, prospective,~     quasi-experimental, and pretest/posttest design. There will be 2 parts in this research: 1)~     validity and reliability test of laser measure for leg length and 2) foot morphology and~     kinetic analysis before and after leg length adjustment. For the first part of this research,~     10 male adults and 20 adults will be recruited for the validity and reliability tests~     respectively. Anthropometric measurements, including body height, body weight, foot length,~     foot width, and heel-ball distance, will be measured after a consent form is signed.~     Participants of the validity test will receive standing pelvic radiography and laser measure~     to measure their leg length. Each participant of the reliability test will receive 2 sessions~     of laser measure using a hand-held laser-distance meter. For the first session, all laser~     measurements will be employed twice by 2 raters with a rest interval of more than 5 min. One~     week later, another session of laser measure will be given again by one of these 2 raters.~     Intraclass correlation coefficient (ICC) will be used to test the interrater reliability,~     intrarater reliability, and validity of the laser measure method. Standard error of~     measurement (SEM), and small real difference (SRD) will be calculated to represented~     intrarater reliability also. For the second part of the research, another thirty adults with~     compensatory pronated foot resulted from LLD will be included in the research project but the~     sample size will be adjusted to the appropriate number according to power analysis. Each~     participant will be asked to fill out the visual analog scale (VAS) and the Oswestry~     Disability Index (ODI) and receive tests containing foot type examination, quiet stance with~     eye opening, quiet stance with eye closed, and level walking. All tests will be performed~     before and after leg length adjustment. The experiment will be completed after collecting 3~     successful trials for each test. All procedures will be done one month later. ANOVA with~     repeated measures will be calculated to compare the differences in these variables among~     before, immediately after, and 1 month following leg length adjustment when the data fit the~     assumptions of normal distribution. Discrete variables or variables with non-normal~     distribution were tested using the Friedman test. All statistical analyses will be calculated~     using SAS 9.1.3. The significant level was set at α = 0.05 while the power was at 0.8.~      Five possible results may be expected from conducting this research project: 1) there will be~     good validity and reliability of the laser distance meter to measure LLD, 2) there will be~     significant differences in measurements of foot type before and after leg length adjustment,~     3) there will be significant differences in kinetic data during quiet stance before and after~     leg length adjustment, 4) there will be significant differences in kinetic data during level~     walking before and after leg length adjustment, and 5) symptom and functional level related~     to LBP will improve after leg length adjustment. Completion of this research project will be~     projected to provide solid and objective evidences for leg length adjustment through views of~     morphology and kinetics in people with pronated foot due to anatomical LLD.~   "
181611|NCT01187680|"~     The purpose of the study is to investigate whether sprayable PEG barrier is effective in~     reducing adhesions in laparoscopic gynecologic surgery.~   "
181612|NCT01187667|"~     Haloperidol is prescribed in high risk ICU patients concerning delirium (50% or more chance~     to develop delirium detected with the delirium prediction model PRE-DELIRIC, or patients with~     history of dementia or alcohol abuse)since the delirium protocol is changed and haloperidol~     is added as a prevention treatment we are gathering information what the effect is on several~     aspects of delirium~   "
181613|NCT01187654|"~     Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery~     and restore blood flow to the heart muscle after myocardial infarction, there may be a~     significant amount of heart tissue that has been irreversibly damaged. Recent studies have~     shown that adult stem cells from bone marrow may be able to improve heart function and~     prevent from heart remodeling due to heart failure.~      This study will evaluate the safety and effectiveness of using adult bone marrow derived stem~     cells for improving heart function in MI patients with Left Anterior Descending (LAD)~     involvement.~   "
181614|NCT01187641|"~     The purpose of this study is to determine whether MRI is more accurate than CT in determining~     the T stage, N stage, depth of tumour invasion and extra mural venous invasion (EMVI)~     preoperatively in colon cancer.~   "
181615|NCT01187628|"~     The objective of this study is to investigate the safety and the effect on reduction of serum~     phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in~     patients with hyperphosphatemia who completed the 8 week double-blind treatment period of~     Study 14817 and are judged to be eligible for the long-term extension study.~   "
181616|NCT01187615|"~     This is a multi-center, open-label, non-randomized Phase I study to define the safety~     profile, maximum tolerated dose (MTD) and potential pharmacokinetic interaction of~     regorafenib in combination with pemetrexed and cisplatin in patients with Stage IIIB or Stage~     IV nonsquamous Non-Small Cell Lung Cancer (NSCLC) and to determine the impact of the combined~     administration on the pharmacokinetics of regorafenib, pemetrexed, and cisplatin.~      In Part A of this trial, regorafenib will be administered in a sequential dosing with a seven~     day wash out period before the next infusion of pemetrexed and cisplatin. Regorafenib will be~     administered at a dose of 160 mg qd from Day 2 to Day 14 followed by a 7 days break.~      In Part B of this trial, regorafenib will be administered continuously from Day 1 to Day 21.~     Only in Cycle 1, regorafenib dosing will start on Day 2 in order to assess the~     pharmacokinetics of pemetrexed and cisplatin without concomitant regorafenib dosing.~   "
181617|NCT01187602|"~     The purpose of this study is to create new tests to identify biomarkers for ovarian cancer so~     that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer,~     researchers will use blood samples before and after treatment to see if disease status can be~     determined by measuring the amount of biomarker.~   "
181618|NCT01187589|"~     This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of~     Aerosol and on Pulmonary Functions in COPD Patients~   "
181619|NCT01187576|"~     Background The present study protocol describes the trial design of a primary care~     intervention cohort study, which examines whether an extended, multi-professional physical~     activity referral (PAR) intervention is more effective in enhancing and maintaining~     self-reported physical activity than ordinary physical activity recommendations. The study~     targets patients with newly diagnosed hypertension and/or type 2 diabetes.~      Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose;~     physical fitness and anthropometric variables; mental health; health related quality of life;~     and cost-effectiveness. Methods/Design The study is designed as a long-term intervention.~     Three primary care centres are involved in the study, each constituting one of three~     treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR,~     lifestyle brochure; 2) Control group A (CA): ordinary recommendations on health behaviours,~     lifestyle brochure; and 3) Control group B: treatment as usual (retrospective data~     collection).~      The intervention is based on self-determination theory and follows the principles of~     motivational interviewing. Physical activity is measured with the International Physical~     Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per~     week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as~     health behaviours; health-related quality of life; motivation to change; mental health;~     demographics and socioeconomic characteristics are assessed with an electronic study~     questionnaire that submits all data to a patient database, which automatically provides~     instant feed-back on the patients' health status.~      Cost-effectiveness of the intervention is evaluated continuously and the intermediate~      - 3 - outcomes of the intervention are extrapolated by economic modelling. The first~     statistical analyses and compilation of results will be performed one year after inclusion of~     the first patient or when the IG and CA have included 60 and 30 eligible patients~     respectively. Discussion By helping patients to overcome practical, social and cultural~     obstacles and increase their internal motivation for physical activity we aim to improve~     their physical health in a long-term perspective. The targeted patients belong to a patient~     category that is supposed to benefit from increased physical activity in terms of improved~     physiological values, mental status and quality of life, decreased risk of complications and~     maybe a decreased need of medication.~   "
181620|NCT01187563|"~     This is an open-label, uncontrolled, observational study in patients with rheumatoid~     arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their~     standard of care.~   "
181621|NCT01187550|"~     This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV~     interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD)~     were treated for 4 weeks with Saizen to compare the response between GHD children born~     appropriate for gestational age (AGA) and those born small for gestation age (SGA) after 4~     weeks of Saizen therapy.~   "
181623|NCT01187524|"~     Background:~        -  In human DNA, the Fragile X (FMR1) gene helps to regulate the nervous and reproductive~          systems. If the gene is abnormal, it can cause different kinds of problems, such as~          abnormal menstrual periods, decreased fertility, muscle tremors, and mental retardation.~          An abnormal FMR1 gene can also make a person more susceptible to other medical~          conditions, such as thyroid problems, high blood pressure, seizures, and depression.~          More research is needed on how abnormalities in the FMR1 gene can lead to these~          problems, and how often these problems appear in individuals with an abnormal FMR1 gene.~        -  Researchers are interested in developing a patient registry of women who have an~          abnormality in the FMR1 gene. This registry will allow researchers to follow~          participants over time and study possible effects of this abnormality on their general~          and reproductive health.~      Objectives:~      - To develop a patient registry of women with an abnormal FMR1 gene and monitor their general~     and reproductive health.~      Eligibility:~      - Women at least 18 years of age who have an abnormal FMR1 gene on the X chromosome.~      Design:~        -  The following groups of women will be eligible for screening for this study:~        -  Those who have a family member with Fragile X Syndrome or mental retardation~        -  Those who have (or have a family member who has) primary ovarian insufficiency, also~          known as premature menopause~        -  Those who have (or have a family member who has) certain neurological problems such as~          tremors or Parkinson's disease.~        -  Eligible participants will be scheduled for an initial study visit at the National~          Institutes of Health Clinical Center. Participants who have regular menstrual periods~          should schedule the visit between days 3 and 8 of the menstrual cycle; those who do not~          have regular periods may have the visit at any time of the month. In addition, all~          estrogen-based treatments (such as birth control pills) must be stopped for 2 weeks~          prior to the study visit.~        -  Participants will have a full physical examination, provide a medical history, and~          provide blood samples for immediate and future testing. Participants will return for~          yearly visits for the same tests for as long as the study continues.~        -  Participants who have or develop primary ovarian insufficiency related to the FMR1 gene~          will also have tests to measure bone thickness and will have a vaginal ultrasound to~          examine the ovaries. These tests will be scheduled for a separate visit, and will be~          repeated every 5 years for the duration of the study.~   "
181624|NCT01187511|"~     Objective:~      To evaluate GSK561679, an orally available, brain penetrant selective CRH1 antagonist for its~     ability to reduce alcohol craving in recently detoxified alcohol dependent women in response~     to stress or alcohol-associated stimuli.~      Study population:~      Up to 60 anxious, alcohol dependent women, aged 21-65 years will be enrolled to complete the~     study in 50 patients.~      Background:~        -  Anxiety, irritability, anger, and depression can all cause stress that may lead to~          continued drinking in heavy drinkers. One way the brain responds to stress is through a~          protein on brain cells called a CRH receptor. Previous research has shown that the CRH~          receptor is involved in negative emotional states and that chronic alcohol consumption~          increases the activity of CRH receptors in the brain. Medications that block CRH~          receptors can decrease stress-triggered alcohol consumption.~        -  GSK561679, an experimental drug that blocks the CRH receptors, can reduce negative~          emotions such as anxiety and a person s desire for alcohol. By looking at the brain s~          response to stress and the study drug using functional magnetic resonance imaging (fMRI)~          scans, researchers hope to learn whether GSK561679 can be an effective treatment for~          stress-related alcohol abuse.~      Objectives:~      - To evaluate the usefulness of GSK561679 in reducing stress-related alcohol craving in~     alcohol-dependent women.~      Design:~        -  Participants in the study will be enrolled in the standard NIH treatment program for~          alcohol dependence, and will be required to stay at the NIH inpatient treatment unit for~          an additional 31 days.~        -  Participants will receive either the study medication or a placebo to be taken once a~          day in the evening for 4 weeks.~        -  Participants will have the following procedures while on the study medication:~        -  Questionnaires about alcohol craving, depression, and anxiety.~        -  Recordings and responses to personal emotional reactions to stressful, nonstressful, and~          alcohol-related situations, with blood samples taken during the responses.~        -  Regular blood tests to measure stress hormones in the blood.~        -  Speech preparation and presentation (Trier test), along with blood samples, to measure~          stress hormones in the blood.~        -  Sessions to measure responses to alcohol-related cues.~        -  Functional magnetic resonance imaging (fMRI) scans.~        -  Participants will return for follow-up visits 1 week and 1 month after stopping the~          study drug and being discharged from the study.~   "
181625|NCT01187498|"~     The primary purpose of this project is to evaluate the effectiveness of behavioral treatment~     compared to standard drug therapy for symptoms of OAB in male veterans.~   "
181626|NCT01187485|"~     The purpose of this study is to see how safe Androderm® (the study drug) is at three~     different doses in subjects with early hormone refractory prostate cancer. In addition,~     information about hormonal levels and the effects of testosterone on quality of life~     including sexual functioning and muscle strength will be collected.~   "
181627|NCT01187472|"~     This protocol was opened to collect long term survival information on subjects enrolled in a~     previous study which evaluated the impact of neoadjuvant chemotherapy and concomitant~     chemoradiotherapy with organ preserving optional surgery on overall survival, time to~     progression, pattern of disease recurrence in patient with locally advanced head and neck~     cancer. The last surviving subject was last treated in 1989, and was lost to follow up in~     2010.~   "
181628|NCT01187459|"~     Background: Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), is a chronic~     relapsing inflammatory disorder of the digestive system. CD affects ~112,000 individuals in~     Canada, of whom 20-25% are diagnosed in childhood or adolescence. The specific cause of CD~     remains unknown; however, it is hypothesized that CD involves a complex interaction of~     several factors, including a genetically susceptible host, the intestinal mucosal immune~     system and microbe population. Several dietary factors have been explored for their potential~     role in the etiology of CD. However, no consensus on the role of diet has emerged. Recent~     evidence suggests a plausible link between a lack of Vitamin D and CD.~      Purpose & Hypothesis: The investigators primary hypothesis is that a greater proportion of~     pediatric CD patients will achieve optimal 25OHD concentration (> 75 nmol/L) on 2000 IU/d~     than 400 IU/d Vitamin D.~      Methods: Pediatric Crohn's Disease patients between 8-18 years of age, and have been in~     remission for at least 4 weeks as indicated by a Pediatric Crohn's Disease Activity Index~     (PCDAI) <10 will be recruited for a double-blind, randomized, controlled trial where they~     will receive one of two dosages of vitamin D (10 or 50 ug/day) and will be asked to continue~     the supplementation for 6 months. Vitamin D levels will be measured in blood at baseline, 3~     months, and 6 months. Dietary vitamin D intake will be estimated using a food frequency and~     lifestyle questionnaire. Data will be analyzed using multiple regression analysis controlling~     for baseline values.~      Expected Results and Conclusions: It is expected that a greater proportion of children~     receiving the 50 ug/day vitamin D supplement will achieve a blood vitamin level >75 nmol/L~     compared to children receiving 10 ug/day. This data will aid policy makers, parents/children~     and healthcare workers in recommending an appropriate vitamin D dosage for the pediatric~     crohn's population.~   "
181629|NCT01187446|"~     The purpose of this study is to determine if vorinostat combined with low-dose total skin~     electron beam therapy (TSEBT) offers superior clinical benefit (efficacy & safety) over~     low-dose TSEBT alone in participants with mycosis fungoides (MF)~      Treatment in this study is TSEBT +/- vorinostat, with participants stratified by MF stage.~   "
181630|NCT01187433|"~     The purpose of this study is to generate immunogenicity and safety data in preparation for~     efficacy studies in Latin America.~      Primary Objectives:~        -  To describe the immune response to dengue viruses before and after each vaccination with~          CYD dengue vaccine.~        -  To evaluate the safety of each vaccination with CYD dengue vaccine.~   "
181631|NCT01187420|"~     The purpose of this study is to assess real time changes in raw and processed EEG in relation~     to the clinical and radiological evidence of cerebral vasospasm.~   "
181632|NCT01187407|"~     The purpose of this study is to assess if LY2216684 (flexible dose of 12 to 18 milligrams~     [mg] or fixed dose of 6 mg once daily) is superior to placebo once daily in the adjunctive~     treatment of participants with Major Depressive Disorder (MDD) who were identified as partial~     responders to an adequate course of treatment with a selective serotonin reuptake inhibitor~     (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.~   "
181805|NCT01185158|"~     The purpose of this study is to find out what effects (good and bad) ZD1839 has on one's~     squamous cell head and neck cancer. The research is being done because currently no effective~     treatment exists for metastatic (spread of cancer cells from one area of the body to another)~     or recurrent squamous cell cancer of the head and neck. The purpose of this study is to find~     out if ZD1839 can shrink tumors or cause tumors to stop growing for a period of time.~   "
181633|NCT01187394|"~     In Canada, 218,000 units of fresh frozen plasma and frozen plasma were transfused in~     2005.Cardiac surgery patients are the largest recipient group for FP transfusions. Despite~     this, no studies have characterized the use of FP in relation to coagulation test~     abnormalities or bleeding, or how these and other clinical determinants influence the~     decision to transfuse FP. Furthermore, no studies have evaluated the effectiveness of FP~     transfusions in correcting laboratory abnormalities or treating bleeding in cardiac surgery.~      Given the varied use of FP transfusions in cardiac surgery, further studies are essential.In~     order to improve current utilization of FP, current use must be understood, and the~     relationship between FP transfusions and the clinical factors that affect the decision to~     transfuse FP.~   "
181634|NCT01187381|"~     This single arm observational study will assess the duration and safety of treatment with~     trastuzumab in routine clinical practice in participants with early or metastatic~     HER2-positive breast cancer. Data will be collected from female participants treated with~     trastuzumab according to the Summary of Product Characteristics and local protocols. Duration~     of observation for each participant is from therapy initiation until permanent~     discontinuation for any cause.~   "
181635|NCT01187368|"~     The objective of this pivotal study is to assess the safety and efficacy of the EVAHEART LVAS~     as a bridge-to-transplant for subjects with end stage heart failure. Subjects will be~     followed for 180 days after the EVAHEART LVAS implant or until cardiac transplant or explant~     for recovery (+ 60 days or discharge). If after 180 days post-implant the subject has not~     received a cardiac transplant or the device has not been explanted, the subject will continue~     to be followed monthly.~   "
181636|NCT01187355|"~     The purpose of this study is to compare two contact lens care solutions in symptomatic~     wearers of silicone hydrogel contact lenses.~   "
181637|NCT01187342|"~     Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute~     and chronic poststroke conditions.~   "
181638|NCT01187329|"~     The overall research plan is to test the hypothesis that intraoperative treatment of~     hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial~     function and short-term outcomes compared with standard glucose management.~   "
181639|NCT01187316|"~     The aim of the present study was to carry out a pilot project comparing the effectiveness of~     two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female~     individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were~     randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and 2)~     transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten~     sessions were held for each patient and two measurements (baseline and 10th session) were~     performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum~     opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be~     carefully selected.~   "
181640|NCT01187303|"~     The purpose of this trial is to determine the efficacy of ofatumumab in patients with~     relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).~   "
181641|NCT01187290|"~     The main objective of this trial is to compare feasibility and efficacy of sequential~     neoadjuvant chemoradiotherapy with 44Gy concomitant boost to neoadjuvant chemotherapy alone.~     Secondary objectives are to assess the value of position emission tomography (PET）in~     predicting pathological response and event-free survival（EFS）in stage IIIA non-small cell~     lung cancer (NSCLC). Further to compare the amount of serum DNA in patients with stage IIIa~     NSCLC before, during and after chemotherapy, before and after radiotherapy (in arm A) and~     during follow-up in patients randomized into the trial and to correlate the Deoxyribonucleic~     acid (DNA) variation with tumor response, remission duration and overall survival.~   "
181642|NCT01187277|"~     The incidence of stroke in the industrial world is still high. Most of the patients are~     suffering from paresis of the affected side, speech and cognition problems. Modern concepts~     of motor learning after stroke favouring a task-specific repetitive high-intensity therapy~     approach to promote motor outcome. In the last couple of years robot-assisted therapy became~     an important part of modern rehabilitation after stroke. But so far there is no clear~     evidence that robot assisted therapy in combination with conventional therapy is more~     effective than conventional therapy alone to promote motor functions after stroke.~   "
181643|NCT01187264|"~     In this study the investigators intend to compare the efficacy and safety of two fixed doses~     of once weekly oral methotrexate in a prospective randomized double blind manner in patients~     with severe plaque type psoriasis.~   "
181644|NCT01187251|"~     The aim of this study is to compare the incidence of tinnitus between mp3 users and~     non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença~     secondary schools. High frequency audiometry and otoacoustic emissions will be~     performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.~   "
181645|NCT01187238|"~     The purpose of this study is to verify the role of adding cisplatin chemotherapy to the~     intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.~   "
181646|NCT01187225|"~     The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces~     blood losses, transfusion requirements and occurrence of clinical complications compared to~     cryoprecipitate in children after cardiac surgery with pump.~   "
181647|NCT01187212|"~     This study investigates the efficacy and safety profiles of sorafenib in combination of~     capecitabine and cisplatin, one of standard chemotherapy regimens in patients with advanced~     gastric cancer.~   "
181648|NCT01187199|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of 3~     other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar). The~     safety of these drug combinations will also be studied.~   "
181649|NCT01187186|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral~     administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with~     normal hepatic function based on the Child-Pugh Classification (CPC).~   "
181806|NCT01185145|"~     Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is~     safe and effective in patients with early stage breast cancer resected by lumpectomy.~   "
181650|NCT01187173|"~     Goal:~      The primary goal of this study is to longitudinally investigate, in head and neck cancer~     (HNC) patients, the potential fibrosis-lymphedema continuum. Specifically, we will examine~     the development, patterns, progression, and prevalence of late-effect fibrosis and/or~     lymphedema, explore potential biological correlatives including pro-inflammatory cytokines~     and genetic polymorphisms, and evaluate the relationship among late-effect fibrosis and/or~     lymphedema and select psychosocial stressors that potentially interact with cytokine~     pathways.~      H: A minimum of 20 percent of HNC patients will experience late-effect fibrosis and/or~     lymphedema.~      H: We will be able to differentiate characteristics patterns of the development of~     late-effect fibrosis and/or lymphedema.~      H: We will be able to differentiate patterns of symptoms associated with late-effect fibrosis~     and/or lymphedema.~      H: We will be able to differentiate patterns of inflammatory response and the development of~     late-effect fibrosis and/or lymphedema.~      H: Select polymorphisms will increase the likelihood of development of late-effect fibrosis~     and/or lymphedema.~      H: Incidence and severity of late-effect fibrosis and/or lymphedema will correlate with total~     dose of radiation to involved anatomical site.~      H: HNC patients with fibrosis and/or lymphedema experience greater levels of depression and~     social withdrawal than those without these conditions.~   "
181651|NCT01187160|"~     The purpose of this study is to assess if the da Vinci® Robotic Surgical System (Intuitive~     Surgical, Inc., Sunnyvale, CA) allows for adequate exposure for transoral resection of~     hypertrophic lingual tonsils in patients with obstructive sleep apnea.~   "
181652|NCT01187147|"~     Asthma is a disease characterized by chronic inflammation in the airways. Recent research has~     demonstrated that one of the reasons for the chronic inflammatory state is an imbalance~     between oxidative stress and antioxidative defenses in patients with asthma.~      Green tea is a common beverage consumed by Chinese patients from all walks of life. Green tea~     contains chemical components that are thought to have immunomodulatory actions in chronic~     inflammation.~      The investigators propose to recruit 35 patients with stable asthma. Recruited subject will~     be given oral tablets containing Green tea extract (GTE) to be taken daily for three months.~     Clinical follow up and assessment will be done at baseline, on completion of GTE intake at~     three months, and at three months after GTE intake has been stopped. A questionnaire on their~     health status and the frequency of symptoms and use of bronchodilators and inhaled steroids~     will be completed, spirometry will be done and a venous blood sample will be taken during~     recruitment and during each reassessment at 3 and 6 months. Measurement of~     oxidants/antioxidants (GSH, GSSG, SOD, CAT and GPx) will be carried out on the blood samples.~     Oxidants/antioxidants will be compared and correlated with lung function results.~      This study would provide us with pilot data as to whether GTE, a strong antioxidant with~     immunomodulatory actions, has any effect on reducing the oxidative stress and improving the~     antioxidant status in patients with asthma and whether these changes are accompanied~     improvement in clinical status.~      Hypothesis Green tea extract (GTE) reduces oxidative stress and improves antioxidant defenses~     in Chinese patients with asthma~   "
181653|NCT01187134|"~     Patients with severe sepsis or septic shock suffer from life-threatening infections. Fast and~     adequate therapy with antibiotics is crucial for survival. Current guidelines recommend the~     application of broad-spectrum antibiotics within 1 hour after diagnosis. However, recent~     studies showed that such treatment is delayed for several hours.~      In this study, medical staff of participating hospitals is trained to achieve a duration~     until antimicrobial therapy of less than 1 hour. Tools of change management are used. The~     data are compared to a control group (hospitals without intervention).~      It is hypothesized that a multifaceted educational program decreases duration until~     antimicrobial therapy and improves survival.~   "
181654|NCT01187121|"~     The objective of this three year project funded by the National Institute of Justice is to~     conduct a program evaluation of the Decide Your Time program at the Hares Corner Office of~     the Delaware Department of Probation and Parole. The program is intended to provide an~     alternative to incarceration by monitoring chronic drug offenders through increased,~     regularly scheduled, known urinalysis testing, coupled with increasing sanctions and referral~     to treatment for positive tests. The program was designed and is being implemented by the~     Delaware Department of Probation and Parole. Offenders will become eligible for the program~     when they test positive for drugs at their initial probation intake at the Hare's Corner~     Probation Office in New Castle, Delaware or are moved from standard probation to intensive~     supervision due to failed urine tests. Due to budgetary constraints, the office lacks~     sufficient resources to place all eligible offenders into the program. The Department of~     Probation thus intends to randomly assign eligible offenders to either intensive supervision~     probation (ISP)(n=400) or the Decide Your Time program(n=400). Those in ISP will receive the~     normal intensive supervision requirements, including weekly visits and random urinalysis.~     Those in the enhanced condition will receive regularly scheduled urinalysis coupled with~     referral to treatment, if required, and a program of graduated sanctions. The Center for Drug~     and Alcohol Studies is conducting an evaluation of the program that involves examining data~     on effectiveness, and collecting and examining data on program implementation, and probation~     officer and client perspectives of how the program worked. It is hypothesized that those~     randomized to the Decide Your Time program will have fewer arrests, violations and positive~     urine screens upon program completion than those randomized to the control condition.~   "
181655|NCT01187108|"~     Chronic mountain sickness is characterized by excessive red blood cell production which~     causes sludging of the vascular system. This high viscosity blood causes heart failure,~     cognitive dysfunction, and strokes. The investigators hypothesize that cobalt which has been~     previously been shown to be an environmental pollutant worsens the overproduction of red~     blood cells. The investigators plan to conduct a 6 week trial in which acetazolamide (already~     shown to improve chronic mountain sickness) and N-acetylcysteine (a drug that removes cobalt~     from the blood) are evaluated in their potential to improve chronic mountain sickness.~   "
181656|NCT01187095|"~     Many couples experience involuntary childlessness and seek treatment at fertility clinics.~     Going through treatment procedures can be very challenging, time consuming and emotionally~     demanding.~      Psychosocial intervention might have a soothing and healing effect on both behavior as well~     on physical matters. Hence, the investigators would like to investigate whether Expressive~     Writing Intervention (EWI) has an effect on stress management as well as on the pregnancy~     rate for couples who are going through fertility treatment.~   "
181657|NCT01187082|"~     Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder~     syndrome) equals the effect of bladdertraining individually for patients with overactive~     bladder.~      The effect of the training is measured in a 3 dimensional scope by the means of 3 primary~     outcome measures used in the statistical evaluation. Symptoms of OAB (either~     (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (VAS score).~   "
182455|NCT01176630|"~     The study is a survey to answer the specific question, What is the prevalence of metabolic~     syndrome in maintenance hemodialysis patients? Metabolic syndrome is a cluster of conditions~     that increase an individual's risk for developing cardiovascular disease and diabetes.~   "
181658|NCT01187069|"~     A huge challenge in type 2-diabetes care is how to motivate patients towards health behaviour~     changes. In Denmark, the tendency is that nurses in general practice provide a large part of~     type 2 diabetes care.~      Observational studies support Self-determination Theory by finding autonomous motivation and~     perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes.~     Hence, research is needed to develop and test interventions that are autonomy supportive.~      Aim To develop a training course for practice-nurses in autonomy support in patients with~     type 2 diabetes, and to evaluate the effect on patient outcomes.~      Methods The development of the intervention was based on literature research and expert~     meetings. The intervention is evaluated in a cluster randomised controlled trial with 40~     Danish general practices,~        -  where nurses, before enrolment in the study, provided consultations to patients with~          type 2 diabetes,~        -  and about 2500 patients with type 2 diabetes, identified in a Diabetes Database.~      The patients will be followed 15 months from nurse-participation in the course. Data will be~     obtained from registers and patient-questionnaires. The hypothesis is that patients with type~     2 diabetes regardless of education level, age, and gender will benefit from the intervention.~   "
181659|NCT01187056|"~     General practitioners (GPs) and patients find it difficult to talk about risk of future~     disease, especially when patients have asymptomatic conditions, and treatment options are~     unlikely to cause immediate perceptible improvements in well-being. Further studies in risk~     communication for disease prevention are needed, as are studies about risk communication~     training for GPs. Aim: 1) to systematically develop, describe and evaluate a complex~     intervention comprising a training programme for GPs in risk communication and shared~     decision-making, 2) to evaluate the effect of the training programme on real-life~     consultations between GPs and patients with high cholesterol levels, and 3) to evaluate~     patients' reactions during and after the consultations. Hypothesis: 1) patients have better~     adherence to chosen treatment.~      The effect of the complex intervention, based around a training programme, will be evaluated~     in a cluster-randomised controlled trial with an intervention group and an active control~     group with 40 GPs and 280 patients in each group.~      The GPs receive a questionnaire at baseline and after 6 months about their attitudes towards~     risk communication and cholesterol-reducing medication. After each consultation with a~     participating high cholesterol-patient, the GPs will complete a questionnaire about decision~     satisfaction.~      The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes~     questions about adherence to chosen treatment, self-rated health, patient enablement, and~     risk communication and decision-making effectiveness. Prescriptions, contacts to the health~     services, and cholesterol level will be drawn from the register of the National Health~     Service of Denmark at baseline and at 6 months.~      In both intervention group and active control group, 12 consultations will be observed and~     tape-recorded. The consultations will be divided between 4 GPs with each 3 patients. The~     patients from these 24 consultations will be interviewed immediately after the consultation~     and re-interviewed after 6 months.Eight purposefully selected GPs from the intervention group~     will be interviewed in a focus group 6 months after participation in the training programme.~     The process and context of the RISAP-study will be investigated in detail using an action~     research approach, in order to describe and analyse research choices, adaptation of~     intervention model to the specific context, and GPs' and patients' reactions to trial~     participation.~   "
181660|NCT01187043|"~     The purpose of this study is to determine the effects of five different doses of Proellex on~     menses, ovulation, liver function, and steady state exposure in women of reproductive age.~   "
181661|NCT01187030|"~     There is little evidence to guide the current use of Frozen Plasma. Despite this, over~     260,000 units of frozen plasma are transfused in Canada annually. Based on the limited~     published data available, the pattern of practice for Frozen Plasma transfusions is highly~     variable and an important number of Frozen Plasma transfusions appear to be inappropriate.~     Given inappropriate use, it is inevitable that a percentage of patients experience~     unnecessary and potentially life-threatening adverse transfusion reactions. Current~     guidelines for Frozen Plasma offer little help in guiding specific clinical decisions as~     their recommendations lack sufficient clinical details. This lack of detail also hinders the~     utility of these guidelines to help monitor and improve clinical practice. Further research~     examining Frozen Plasma transfusions including an understanding our current use is critical~     to improve the utilization of this valuable and limited resource.~   "
181662|NCT01187017|"~     Background:~        -  Severe aplastic anemia (SAA) can lead to problems with bone marrow health and result in~          low blood cell counts, which require frequent transfusions. Standard initial treatment~          for SAA involves injections of antithymocyte globulin (ATG) plus cyclosporine (CsA).~          Patients with SAA who do not respond to initial treatment with ATG (refractory) have a~          high risk of dying without additional treatment. In these cases, for those who do not~          have a matched bone marrow transplant donor there is no well-defined standard therapy.~          In our experience with patients who do not respond to horse ATG + CsA, only about~          one-third of patients who are re-treated with rabbit ATG + CsA improve. Experience with~          cyclophosphamide in the treatment of refractory severe aplastic anemia suggests that~          this drug is able to improve blood counts in about 50% of cases. However, the~          cyclophosphamide regimen has been associated with a significant infection risk (mostly~          caused by fungus) in studies conducted over 10 years ago due to the lowering of the~          white blood cell levels.~        -  Better antibiotic drugs against fungus have been developed and are widely used to treat~          patients who have low white blood cell counts and are at risk of developing infections.~          In SAA patients in particular, these newer antibiotics have had a large impact in~          preventing and treating fungus infections. Researchers are revisiting the use of~          cyclophosphamide at lower doses to minimize its side effects given in combination with~          another immune suppressant, fludarabine.~      Objectives:~      - To determine the safety and effectiveness of the combination of fludarabine plus~     cyclophosphamide in treating severe aplastic anemia that has not responded to initial~     treatments.~   "
181663|NCT01187004|"~     Hypothesis of the study is that patients undergoing major cardiac surgery can develop~     extracardiac complications correlated to cardiopulmonary by pass.~   "
181664|NCT01186991|"~     This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed~     to preliminarily estimate the efficacy and evaluate the safety and tolerability of~     onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus~     placebo + bevacizumab + paclitaxel in participants with metastatic or locally recurrent,~     triple-negative breast cancer who either have not received treatment (first-line) or have~     progressed after one conventional cytotoxic chemotherapy regimen (second-line).~   "
181665|NCT01186978|"~     This study will evaluate whether a reduction in the radiation dose and field size will~     maintain a high rate of local control while minimizing the risk of acute and late toxicity.~      Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy~     while maintaining high rates of local control in patients who had a negative PET scan~     following rituximab-containing chemotherapy.~   "
181666|NCT01186965|"~     The purpose of this study is to to develop and evaluate the feasibility, usability, and~     effect of participation in SLIDES (a virtual diabetes community in Second Life) for providing~     interactive diabetes education, support, and resources.~   "
181667|NCT01186952|"~     Inactivity and excess energy consumption are leading causes of obesity and type 2 diabetes~     which are associated with increased cardio-metabolic risk. In order to reduce the~     cardiovascular risk associated with type 2 diabetes, the Canadian Diabetes Association~     guidelines (2008) recommends weight loss through caloric restriction and structured physical~     activity. However, the comparative effects of different methods to obtain caloric deficit for~     weight loss remains to be elucidated. The main objective of this study is to assess the~     impact of two strategies of caloric deficit: diet alone or diet and exercise on total fat~     mass, epicardial fat and cardiovascular risk factors in overweight and obese adults with type~     2 diabetes and at high risk of cardiovascular disease.~   "
181668|NCT01186939|"~     At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could~     be enrolled in an optional extension phase in order to continue treatment with azacitidine~     until it became commercially available; the continued treatment was for ethical and safety~     reasons only and not to provide additional efficacy data.~   "
181669|NCT01186926|"~     The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the~     HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects~     with obstructive sleep apnea (OSA).~   "
181670|NCT01186913|"~     Individuals with Primary Immune Deficiency (PID) may develop severe, life-threatening~     infections as a result of inherited defects in the genes that normally instruct blood-forming~     cells to develop and to fight infections. PID diseases include Severe Combined Immune~     Deficiency (SCID), leaky SCID, Omenn syndrome (OS), and Reticular Dysgenesis (RD). PIDs may~     be treated by transplantation of bone marrow stem cells from a healthy person or, in some~     cases, by enzyme replacement or by gene therapy. Patients with SCID were among the first to~     receive bone marrow stem cell (also called hematopoietic cells) transplantation (HCT) more~     than 40 years ago, and HCT is the standard treatment today for this group of diseases. Since~     PID diseases are rare, there are not enough patients at any single center to determine the~     full range of causes, natural history, or best methods of treatment. For this research study~     many PID centers across North America have organized into the Primary Immune Deficiency~     Treatment Consortium (PIDTC) to pool their experience and study PIDs together. The overall~     goal of this study is the prospective evaluation of children with SCID and related disorders~     who are treated under a variety of protocols at participating institutions. The study aims to~     identify variables contributing to the best outcomes for HCT.~   "
181671|NCT01186900|"~     The investigators propose to conduct a, two armed, randomized, controlled pilot study to~     assess the clinical effects of a) open incision, drainage with daily packing changes,~     compared to b) Ultrasound guided needle aspiration, in drainage of uncomplicated cutaneous~     abscesses below the skin surface of adult emergency department patients using concealed~     allocation in evaluating patient satisfaction.~   "
181672|NCT01186887|"~     The aim of this study is to directly compare the clinical outcomes of both the celecoxib and~     placebo groups following anterior cruciate ligament (ACL) reconstruction. The study will have~     short and long term goals. Validated outcome measures will aim to quantify pain control at 2~     weeks after surgery, as well as knee function at 2 year follow-up. Groups will be compared~     using pain control scales, and functional knee outcome scores. The first null hypothesis~     tested by this study is that the celecoxib group experiences equal pain control compared with~     the placebo group. The second null hypothesis is that no knee function difference will be~     found between the celecoxib and placebo groups.~   "
181673|NCT01186874|"~     To survey the prevalence and the mortality of the Acute Lung Injury/ Acute Respiratory~     Distress Syndrome (ALI/ARDS) in 12 university hospital ICUs in Shanghai.~   "
181674|NCT01186861|"~     A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1~     randomization scheme.~   "
181675|NCT01186848|"~     This was a prospective randomized controlled study comparing the efficacy of micro-focused~     ultrasound when used in conjunction with 1550-nm erbium-doped fractionated laser versus~     1550-nm erbium-doped fractionated laser alone for treatment of striae distensae(stretch~     marks).~      Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment~     every 2 weeks for a total of 4 treatments on one side and the contralateral side received~     micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks~     for a total of 4 treatments with site-match control area of baseline striae on each side.~      The primary outcome measure by two dermatologists blindly compared the two areas of striae~     distensae on each side from live subjects using a questionnaire and quartile rating scale on~     the final follow-up visit.~      This study was a pilot study designed to determine the feasibility of these procedures.~   "
181676|NCT01186835|"~     The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in~     conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of~     wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin~     alone. These two products have been FDA approved to improve the appearance of facial~     wrinkles.~   "
181677|NCT01186822|"~     This is a 26 week randomized controlled study. The study consists of, in order, an enrollment~     visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will also be~     telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve comprehensive~     assessments of the patients lung condition, including post-bronchodilator spirometry, Shuttle~     walk distance, BODE index, health status (SGRQ) and symptoms (CCQ). Sputum and serum samples~     will also be collected at these visits for microbiological and inflammation analysis. Sputum~     will be obtained with the Lung Flute as an induction device and Pulse Oximetry will be~     assessed prior to and after use of the Lung Flute. Clinic and telephonic visits will collect~     information regarding compliance with the use of the Lung Flute, adverse events and~     exacerbation history.~   "
181678|NCT01186809|"~     The purpose of the Phase IIA study are to:~        1. define the safety profile~        2. evaluate the efficacy of a sequential infusion of unmanipulated Donor Lymphocyte~          Infusions (DLI) and Cytokine Induced Killer (CIK) cells for the treatment of molecular,~          cytogenetic or hematologic relapse after hematopoietic stem cell transplantation and The~          progression free survival and the overall survival after the sequential infusion of~          Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer(CIK) cells.~   "
187500|NCT01110317|"~     The purpose of this study is to evaluate the concentration of paliperidone in the blood after~     intramuscular injection in upper arm (deltoid muscle) or in the buttock (gluteal muscle) in~     patients with schizophrenia.~   "
181679|NCT01186796|"~     Participants are being asked to take part in this research study to learn why growth~     hormone(GH) levels decline when estrogen production falls at the time of menopause. GH is a~     hormone released from the pituitary gland that affects bone, muscle, and fat. Estrogen is a~     female hormone. Doctors believe that lower estrogen is one of the reasons that GH diminishes~     in postmenopausal women. However, estrogen does not fall completely. This raises the question~     whether the little bit of estrogen that is left is doing anything. Lack of GH makes bones~     thinner, muscles weaker, and fat stores larger. To learn whether the low amount of the body's~     own estrogen maintains GH secretion after menopause, the investigators need to stop any~     estrogen you might be taking and then partially block the effect, if any, of your own~     estrogen. The investigators will use a new estrogen-blocking drug (fulvestrant).~     Fulvestrant(which also goes by the tradename, Faslodex) was recently approved by the Food and~     Drug Administration (FDA) to treat breast cancer. Fulvestrant is being used in a non-FDA~     approved manner in this study (not to treat breast cancer, but to study the effect on Growth~     Hormone secretion). The drug interferes with how estrogen works in the body, except in the~     brain. The study that you are considering now tests whether your own estrogen works outside~     the brain to maintain GH secretion in postmenopausal women. This concept is important,~     because the brain controls how the pituitary gland secretes GH.~   "
181680|NCT01186783|"~     MODIfY is a prospective, single center, open label, randomized, controlled two arms, Phase~     II-trial to evaluate the ability of ivabradine to reduce an elevated heart rate in Multiple~     Organ Dysfunction Syndrome (MODS) patients. The primary end point is the proportion of~     patients with a reduction of heart rate by at least 10 beats per minute (bpm) within 4 days.~     This trial will randomize 70 patients (men and women, aged ≥ 18 years) with newly diagnosed~     MODS (Acute Physiology and Chronic Health Evaluation (APACHE) II-score ≥ 20, diagnosis within~     ≤ 24 hours), with an elevated heart rate (sinus rhythm with HR ≥ 90 bpm) and~     contraindications to beta-blockers (BBs). Treatment period will last 4 days. All patients~     will be followed for up to six months.~   "
181681|NCT01186770|"~     MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind,~     placebo-controlled, parallel-group study in order to evaluate the safety and efficacy of oral~     MNTX for the treatment of opioid induced constipation in subjects with chronic, non-malignant~     pain.~   "
181682|NCT01186757|"~     Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers~   "
181683|NCT01186744|"~     The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5~     mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and~     subsequent withdrawal of active treatment at various timepoints during the 16 week double~     blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP~     690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and~     subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID~     and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are~     candidates for systemic therapy or phototherapy.~   "
181684|NCT01186731|"~     LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc.~     Docetaxel (currently marketed as Taxotere) is an anti-microtubule agent that prevents cell~     division. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced~     toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence~     obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered~     at higher dose to induce greater effectiveness of LE-DT. In addition, docetaxel has shown~     positive activity of protein bound taxane therapy in treating patients with pancreatic~     cancer. The current Phase II study is designed to accomplish the following objectives:~        1. Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every three~          weeks in pancreatic cancer patients with locally advanced or metastatic disease~        2. To evaluate the progression-free survival and overall survival~        3. To correlate secreted protein acid rich in cysteine expression with tumor response~        4. To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention as~          well as myelotoxicity~        5. To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic~          endpoints, including toxicities.~   "
181685|NCT01186718|"~     The purpose of this project is to quantify 3-dimensional (3-D) cervical motion pattern~     changes that result from osteopathic manipulation treatment (OMT) in an experimental subject~     group diagnosed with somatic dysfunction. The kinematic data will include the entire 3-D~     motion trajectories of the head, resulting in range of motion (ROM) and angular data for the~     primary and secondary motions.~   "
181686|NCT01186705|"~     The purpose of this study is to test a new drug called MK-2206 for metastatic colorectal~     cancer. This drug is being tested in a subgroup of patients with colorectal cancer whose~     tumors have changes in certain genes that may make them more likely to respond to this new~     medication. As tumors develop, the cells within the tumor acquire mutations within genes,~     allowing them to grow more effectively. We will be testing your tumor for mutations involving~     two genes - KRAS and PIK3CA. Patients whose tumors have a normal copy of the KRAS gene and a~     mutation within the PIK3CA gene will be eligible to participate in this study.~      This study is a phase 2 study. The goal of a phase 2 study is to find out what effects, good~     and/or bad, a new treatment has against a certain type of cancer.~   "
181687|NCT01186692|"~     The purpose of this study is to confirm the short-term hemodynamic effectiveness results~     achieved by real-world providers are equivalent to the historical control established in the~     IDE study.~   "
181698|NCT01186549|"~     Objectives: Injection pain and hypotension are two main adverse effects of propofol which~     distresses patient. The aim of this prospective double blind study was to compare the effect~     of ephedrine -lidocaine combination with lidocaine and ephedrine on injection pain and~     hemodynamic changes due to propofol induction.~      Methods: 165 adult patients, aged 20 to 60 yr, Patients were randomly allocated to one of 5~     groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30microgram/kg (E30),~     ephedrine 70 microgram/kg(E70), lidocaine 0.5mg/kg -ephedrine 30 microgram/kg(LE) or 2ml~     saline (S) intravenously. After one minute propofol 2 mg/kg into a dorsal hand vein was~     injected. Face pain scale and verbal rating scale, arterial blood pressure and heart rate~     were recorded before induction, just before intubation, and one minute after intubation~   "
187534|NCT01109875|"~     The purpose of this study is to determine the incidence of Fabry Disease in young stroke~     patients in an Israeli stroke clinic.~   "
181688|NCT01186679|"~     The projected data related to the burden of spinal cord injuries induced limb paralysis in~     India is quite alarming. This is attributed to the rapid industrialization and economical~     development in the country. Increase in vehicular traffic has caused numerous road traffic~     accidents. Rapid increase in populations, development in the computer technology and real~     estate business lead to construction of huge buildings which indirectly adds to the injuries~     due to fall. Spinal cord injuries could not be treated adequately with the prevailing~     treatment modalities. In view of this, there is definitely an urgent need for finding~     different methods of treatment for these patients who cannot undergo established modalities~     of treatment or these have been tried unsuccessfully. Since a large number of these patients~     will loose their productive life and at the prime of their lives, one such alternate therapy,~     which seems to offer some promise, is stem cell therapy, which has been well studied and~     published in prestigious journals.~      In our present study, we want to evaluate the safety and efficacy of autologous bone marrow~     derived stem cells surgically transplanted directly into the lesion site with glial scar~     resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for~     4 indian patients of acute and subacute injury.~   "
181689|NCT01186666|"~     In this study, multimodal imaging of atherosclerosis and dosage of new circulating biomarkers~     will be used to compare patients with stable or unstable coronary artery disease~   "
181690|NCT01186653|"~     National Institute for Clinical Excellence (NICE) guidelines recommend high dose inhaled~     steroids for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD, a~     common chronic disease related to smoking) who are having two or more exacerbations requiring~     treatment with antibiotics or oral steroids in a 12 month period. The preparations licensed~     for this indication commercially available are Symbicort® and Seretide®. High dose inhaled~     steroids (contained in both) can cause suppression of the adrenal glands. The investigators~     want to assess adrenal suppression caused by the two preparations and compare. The results~     could guide investigators in prescribing these preparations.~   "
181691|NCT01186640|"~     Study hypothesis: Simultaneous FMC-Alemtuzumab administration followed by Alemtuzumab~     maintenance therapy in patients with T-PLL is feasible, safe and efficient.~   "
181692|NCT01186627|"~     A specified version of the Apgar-Score, that can be used in newborns under resuscitation, was~     developed and its value to predict chronic damage in preterm infants will be tested.~   "
181693|NCT01186614|"~     Sudden out-of-hospital cardiac arrest (OHCA) is a leading cause of death in Australia. The~     most common cause of OHCA is a heart attack. The current treatment of OHCA is resuscitation~     by ambulance paramedics involving CPR, electrical shocks to the heart, and injections of~     adrenaline. In more than 50% of cases, paramedics are unable to start the heart and the~     patient is declared dead at the scene. Patients with OHCA who do not respond to paramedic~     resuscitation are not routinely transported to hospital because it is hazardous for~     paramedics to undertake rapid transport whilst administering chest compressions and there is~     currently no additional therapy available at the hospital that would assist in starting the~     heart.~      However, a number of recent developments suggest that there may be a new approach to the~     resuscitation of this group of patients who would otherwise die.~      Firstly, Ambulance Victoria have recently introduced portable battery powered machines that~     allow chest compressions to be safely and effectively delivered during emergency ambulance~     transport.~      Second, The Alfred ICU will shortly be implementing a new protocol whereby the patient in~     cardiac arrest can immediately be placed on a heart-lung machine. This is known as~     extra-corporeal membrane oxygenation (ECMO).~      Third, the brain can now be much better protected against damage due to lack of blood flow~     using therapeutic hypothermia which is the controlled lowering of body temperature from 37°C~     to 33°C. Clinical trials have demonstrated that this significantly decreases brain damage~     after OHCA.~      Finally, The Alfred Cardiology service has an emergency service for reopening the blocked~     artery of the heart in patients who present with a sudden blockage of the heart arteries.~     This is currently not used in patients without a heart beat because of the technical~     difficulty of undertaking this procedure with chest compressions being undertaken.~      This study proposes for the first time to implement all the above interventions when patients~     have failed standard resuscitation after OHCA. When standard resuscitation has proved futile,~     the patient will be transported to The Alfred with the mechanical chest compression device,~     cooled to 33°C, placed on ECMO, and then transported to the interventional cardiac catheter~     laboratory. The patient will then receive therapeutic hypothermia for 24 hours. Subsequent~     management will follow the standard treatment guidelines of The Alfred Intensive Care Unit.~   "
181694|NCT01186601|"~     The study will be conducted as an open label, single-dose, explorative study with patients~     with histologically proven cancer and, preferably, tumor positive lesions in previously~     performed nuclear medicine imaging examinations.~      The investigational drug will be given as a single administration in a dose of </= 0.1 mg~     BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be~     approximately 8 days.~   "
181695|NCT01186588|"~     The purpose of the study is to determine the concentration of canagliflozin in blood and~     urine samples after the administration of canagliflozin to study participants with mild or~     moderate hepatic (liver) impairment compared with study participants with normal hepatic~     function.~   "
181696|NCT01186575|"~     Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and~     UNAIDS recommend that male circumcision should be recognized as an efficacious intervention~     for HIV prevention especially in countries and regions with heterosexual HIV epidemics and~     low male circumcision prevalence. As a result, programs have been introduced and scaled up~     for voluntary medical male circumcision. Kenya leads with the largest expansion of services.~      Early resumption of sexual intercourse after MC may have deleterious effects, including~     higher rates of post-operative surgical complications, and higher HIV acquisition among~     females in couples that resume sexual activity before certified wound healing. In the context~     of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to~     assess wound healing and to deliver risk reduction counseling. Abstinence from sexual~     intercourse before complete wound healing would reduce the rate of post-operative adverse~     events and minimize the risk of HIV transmission from HIV-infected men to their uninfected~     female partners.~      To the investigators knowledge, the effect of reminders delivered via text messaging to~     promote adherence to clinic visits and abstinence after MC has not been investigated. The~     investigators propose a randomized controlled trial in which men who will have undergone~     voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive~     either the intervention (context-sensitive text messages after circumcision) or the control~     condition (usual care). This study seeks to determine (a) the effect of regular text messages~     sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic~     visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days~     post-procedure after receiving regular text messages versus usual care within the 42 days~     post-circumcision; and (c) to identify potential predictors of failure to attend the~     scheduled 7-day post-operative visit and early resumption of sexual intercourse.~   "
181697|NCT01186562|"~     The purpose of the study is to test the effects of sitagliptin on the need for insulin (the~     hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet~     autotransplant for chronic pancreatitis.~   "
181699|NCT01186536|"~     The objective of this project is to determine the effect of 9 months of progressive~     resistance training with daily whey protein supplements on the body composition (changes in~     muscle and fat) in young adults. The investigators hypothesize that those individuals who~     receive whey protein supplements will have larger gains in muscle and larger losses of fat~     tissue in response to resistance training compared to those who receive supplements of soy or~     carbohydrate.~   "
181700|NCT01186523|"~     In order to examine potential gender differences in the weight loss response to exercise, the~     investigators propose to compare equal energy expenditure of exercise for overweight men and~     women using levels of exercise energy expenditure that the investigators have previously~     shown to prevent weight gain or promote weight loss. The investigators will randomize men and~     women to an exercise group, 5 days/week, for 9 months, with an energy expenditure of 400~     kcal/exercise session, a group with 600 kcal/ exercise session, or a control group. 1)The~     investigators hypothesize that men and women randomized to sedentary control will gain~     weight, those randomized to 400 kcal/exercise session will maintain weight (will not gain),~     and those randomized to 600 kcal/exercise session will lose ~5% of body weight. 2) The~     investigators hypothesize there will be no differences for weight loss between genders at~     either 400 or 600 kcal of energy expenditure of exercise since men and women will have equal~     amounts of energy expenditure of exercise. 3) The investigators hypothesize that men and~     women randomized to 400 kcal/exercise session will completely compensate for the energy~     expended during exercise by altering energy intake and/or spontaneous activity and that men~     and women participants randomized to 600 kcal/exercise session will not completely~     compensate. The investigators believe the findings from this study could have important~     implications for exercise guidelines for weight loss.~   "
181701|NCT01186510|"~     Pulmonary dysfunction presumably linked to an inflammatory response is frequent after cardiac~     operations using cardiopulmonary bypass (CPB) and pulmonary hypoperfusion.~      Aim of the study: To evaluate the protective effect of continuous pulmonary perfusion with~     oxygenated blood during aortic crossclamping on the inflammatory response.~   "
181702|NCT01186497|"~     The purpose of the study is to investigate the bioavailability (rate and extent of~     absorption) of rabeprazole sodium when a sprinkle capsule granule formulation of rabeprazole~     sodium is mixed with different dosing vehicles (food, others) and is administered to healthy~     adult volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esophageal~     Reflux Disease (GERD). GERD is a condition in which the esophagus (tube from throat to~     stomach) becomes irritated or inflamed because of acid backing up from the stomach.~   "
181703|NCT01186484|"~     The purpose of this study is to assess pharmacodynamics and safety of JNJ-212082 in order to~     select the recommended dose of JNJ-212082 for patients with castration resistant prostate~     cancer.~   "
181704|NCT01186471|"~     This study in patients with stable schizophrenia will investigate the effect of nicotine on~     arousal, cognitive task and social cognition after acute dose administration.~   "
181705|NCT01186458|"~     The purpose of this study is to determine the effectiveness of fludarabine, Velcade, and~     rituximab treatment regimen in patients with relapsed or refractory follicular non-Hodgkin~     lymphoma.~   "
181706|NCT01186445|"~     The purpose of this study is to determine whether intracoronary injection of morphine~     chlorhydrate is effective to limit ischemia-reperfusion lesion during percutaneous coronary~     angioplasty in patients with acute myocardial infarction (AMI).~   "
181707|NCT01186432|"~     This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with~     neovascular AMD.~   "
181708|NCT01186419|"~     The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new~     oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a~     medication taken by mouth that causes the body to get rid of iron. Iron chelators are used in~     patients with β-thalassemia and other forms of anemia who experience iron overload - iron~     increases in the body as a result of regularly required blood transfusions. Patients who~     qualify will be randomized to receive one of two doses of FBS0701 for up to 24 weeks (6~     months) with a total study duration of up to 33 weeks. These patients will be eligible to~     participate in a dosing extension for up to 72 weeks. The maximum duration of dosing will be~     up to 96 weeks. The safety of patients will be monitored frequently during the study by~     physical exams, ECGs, and blood tests. To assess the amount of iron in the liver and heart,~     each patient must undergo 6 MRI scans during the study. Patients will not need to stay in the~     hospital for this study but will need to visit the outpatient clinic up to 28 times over the~     96 week period. Patients currently taking an iron chelator will be required to stop for a~     total of up to 26 weeks. The results of this study will help to determine if FBS0701 may be~     effective as an iron chelator.~   "
181709|NCT01186406|"~     The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at~     the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and then~     the combination of Avastin and Temodar, after radiation is complete, on malignant brain~     tumors.~      About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose~     of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation.~     Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed~     dose of Avastin intravenously (through the vein) every 14 days. They will also be given a~     higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.~   "
181710|NCT01186393|"~     The purpose of this study is to test whether diets that contain potatoes and differ in~     glycemic index/load will be useful in weight loss, blood sugar control and maintaining~     current body weight.~   "
181711|NCT01186380|"~     The objective of this Study is to demonstrate the safety of the PET-512MC TEE transducer as~     it is inserted and transitioned into the esophagus through the mouth.~   "
181712|NCT01186367|"~     The purpose of this study is to compare the effects of 3 different approaches to exercise~     training in women with early stage breast cancer who have completed all primary treatments~     (except hormone therapy, if appropriate). Prior research in women with early stage breast~     cancer has shown that some treatments may have an adverse impact on physical fitness levels~     leading to feelings of fatigue and poor quality of life. Supervised exercise training has~     been shown to reduce some of these side-effects. However, all the exercise programs have~     followed essentially the same approach. This study is designed to see if a different approach~     to exercise training is more effective than the conventional approach currently in use.~   "
181807|NCT01185132|"~     In the setting of radiotherapy as part of breast-conservation therapy for patients with early~     stage breast cancer, the novel planning and delivery method of intensity modulated~     radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal~     external beam radiotherapy, spares more normal breast and lung tissue, and may lead to~     improved clinical outcomes.~   "
181713|NCT01186354|"~     This research study is being conducted to learn about how health and genetic literacy (i.e.,~     how well a person understands health and genetic information) affects a person's ability to~     understand genetic risk information for Type 2 diabetes and whether that person chooses to~     change their lifestyle and health behaviors to reduce their risk. The investigators also want~     to learn if the manner in which the genetic risk information is communicated affects the~     level of understanding and potential behavior changes. Participants will be tested for~     genetic risk of developing Type 2 diabetes and will received results either via a web-based~     computer program, or in-person from a genetic counselor.~   "
181714|NCT01186341|"~     Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient~     Clinics indicate that pain was the leading reason for patient visits. As a precursor to a~     large multi-site clinical trial, this study aims to determine the feasibility of collecting~     outcomes data on integrative treatment for pain. These preliminary data will also provide an~     estimation of effect size for powering the multi-site clinical trial.~   "
181715|NCT01186328|"~     An experimental drug called EZN-3042 targets survivin, a protein expressed in leukemia cells~     at relapse that promotes the leukemia cells to grow. The main goal of this phase I study is~     to find out the dose of EZN-3042 that can be safely given without serious side effects both~     alone and in combination with standard chemotherapy drugs during re-induction.~   "
181716|NCT01186315|"~     Eligible veterans, National Guardsmen & Reservists with post-traumatic stress disorder (PTSD)~     and problems with addiction will be randomly assigned to one of two treatment conditions. All~     participants will undergo exposure therapy, a gold standard behavioral treatment for PTSD for~     10 weeks. In addition to exposure therapy, some participants will be randomly assigned to~     receive (1) virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin,~     cigarette, and/or alcohol use, and (2) cellular phone-based reminders of learning (extinction~     reminders, or, ERs) to VR exposure (available 24 hours per day/7 days per week) to high-risk~     contexts for drug use. The main hypothesis is that those participants who receive exposure~     therapy + VR/ERs will demonstrate less substance use and lower PTSD symptoms during~     treatment, at post-treatment, and at follow-up than those participants who only receive~     exposure therapy. At study completion, a total of 123 subjects signed consent.~   "
181717|NCT01186302|"~     The purpose of the study is to compare the safety, effectiveness, and acceptability of~     medical abortion provided by doctors and midlevel providers in a developing country where~     doctors are scarce, such as Nepal. This study is the first to evaluate the independent~     provision of medical abortion by trained nurses and auxiliary nurse midwives compared to~     doctors by assessing differences in safety, clinical outcomes, case management~     decision-making, and acceptability. This study provides scientifically valid data on the~     administration of medical abortion by midlevel providers working independently in a~     low-resource, developing country setting. The evidence generated by the study will assist~     policy makers in developing countries interested in expanding safe abortion services by~     eliminating the legal requirement limiting prescription of medical abortion to doctors where~     medical abortion is not restricted by law.~   "
181718|NCT01186289|"~     The primary aim of our prospective, randomized, double-blind interventional clinical trial is~     to determine the effectiveness of high dose atorvastatin therapy to reduce post operative~     cognitive dysfunction (POCD) in patients undergoing cardiac valve surgery. We hypothesize~     that therapy with high dose atorvastatin will significantly reduce the incidence and/or~     severity of POCD.~   "
181719|NCT01186276|"~     This study will assess whether dietary fiber supplements can reduce the production of~     chemicals which are produced by colon bacteria and normally excreted from the body by the~     kidney, but build up in the body in patients on hemodialysis.~   "
181720|NCT01186263|"~     The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled~     albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic~     artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres~     (SIR- spheres).~   "
181721|NCT01186250|"~     The purpose of this study is to determine the benefit of using the FDA-approved~     insulin-sensitizing agent, Pioglitazone, on human heart transplant recipients. The objectives~     of this project are to (1) determine if pioglitazone effectively treats insulin resistance in~     heart transplant recipients, and (2) to determine whether pioglitazone therapy after heart~     transplantation impacts the development or progression of cardiac allograft vasculopathy~     (CAV), a form of chronic rejection after heart transplantation.~   "
181722|NCT01186237|"~     Recent national surgical quality guidelines (Surgical Care Improvement Project, National~     Hospital Inpatient Quality Measures)state that removal of urinary catheters should occur by~     post-operative day two for all surgical patients. These guidelines exclude neither patients~     who have undergone rectal surgery nor those with epidural analgesic catheters. The common~     practice among most colorectal surgeons is to leave urinary catheters in for three to five~     days for patients who have undergone rectal operations, due to concern for urinary retention.~     This study aims to explore the outcomes of following the national surgical guidelines for~     early urinary catheter removal, especially with regards to urinary retention and urinary~     tract infection.~   "
181723|NCT01186224|"~     To assess the efficacy and toxicity of plerixafor (AMD 3100) together with granulocyte-colony~     stimulating factor (G-CSF) for stem cell mobilisation, in patients with myeloma or lymphoma~     requiring high dose chemotherapy with stem cell rescue.~   "
181724|NCT01186211|"~     This proposal outlines the investigators plan to develop, evaluate and implement an~     accelerated in hospital and community rehabilitation following total knee arthroplasty (TKA)~     leading to outpatient TKA. The benefits of applying current concepts of improved~     postoperative analgesia and less invasive surgical technique are expected to improve~     objective parameters of knee function, increase patients satisfaction, while reducing health~     care resources requirements as compared with standard rehabilitation. The innovation of~     combining best practices from orthopaedic sports medicine, Anesthesia, Physiotherapy and Knee~     reconstruction are expected to realize this goal.~   "
181725|NCT01186198|"~     This is a prospective, single-arm, open-label, multi-center, observational study to assess~     the acute safety and efficacy of MINI TREK RX 1.20 mm, for descriptive purposes only.~   "
188105|NCT01102400|"~     The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese~     patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma~     (expansion part).~   "
181726|NCT01186185|"~     The standard of care treatment of sudden hearing loss uses a type of steroid called~     glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and~     dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone~     is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work~     by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In~     animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving~     hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The~     purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.~   "
181727|NCT01186172|"~     Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes~     it is very difficult to treat the infection and it is necessary to remove the device. The~     purpose of this study is to determine the efficacy of instilled ethanol (ethanol lock~     therapy) versus instilled antibiotics (antibiotic lock therapy) to save long-term venous~     device when infected, preventing their removal.~   "
181728|NCT01186159|"~     To investigate the dose-effect relations among the expression of COX-2 in polymorphonuclear~     leukocytes (PMNL) and macrophages, systemic and local inflammatory response and postoperative~     pain~   "
181729|NCT01186146|"~     This is randomized-controlled trial to evaluate the difference of composite of cardiac death,~     myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin~     monotherapy group after 1-year of drug-eluting stents implantation.~   "
181730|NCT01186133|"~     The objective of this study is to evaluate effectiveness and safety of the new drug-eluting~     stent (DES), as compared with the first-,second-,third-, and fourth-generation DES, in the~     real world daily practice.~   "
181731|NCT01186120|"~     This randomized study is a multi-center, randomized, study to compare the efficacy of~     biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long~     coronary lesions.~   "
181732|NCT01186107|"~     The purpose of this study is to establish the safety and effectiveness of coronary stenting~     with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment~     of de novo coronary stenosis in patients with diabetic patients.~   "
181733|NCT01186094|"~     This randomized study is a multi-center, randomized, study to compare the efficacy of~     sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation for long~     coronary lesions.~   "
181734|NCT01186081|"~     Based on the potential advantaged of preoperative chemoradiotherapy and oral~     fluoropyrimidine, the investigators planned a prospective randomized phase III trial which~     compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional~     radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy~     regimen in locally advanced rectal cancer.~   "
181735|NCT01186068|"~     The purpose of this study is to evaluate the dose-response relationship (effect) of four~     concentrations of V-101 Cream in patients with erythematous(redness) rosacea.~   "
181736|NCT01186055|"~     In the current study, the investigators propose to test: (1) whether brain activation and~     connectivity in a resting state, assessed by ASL perfusion MRI, BOLD fMRI, and diffusion~     tensor imaging (DTI) predicts smoking relapse, and (2) whether brain activation, assessed by~     BOLD fMRI during performance of neurobehavioral probes for executive cognitive function,~     stress and cue reactivity, predicts smoking relapse.~   "
181737|NCT01186042|"~     The purpose of this study is to find the best tests to use to investigate the differences~     between older and younger people with HIV disease. Test to be included will measures of~     memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.~   "
181738|NCT01186029|"~     This study is looking at whether the addition of a fairly new drug for the treatment of~     post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting(PDNV)will~     provide added efficacy if added to 2 drugs that are already used as a standard of care for~     PONV and PDNV.~      The patients that will be looked at will be deemed at higher risk for PONV and PDNV based on~     the procedure they are having done and/or on patient risk factors.~   "
181739|NCT01186016|"~     This study will test the effects of an educational program about genetics and smoking on~     smokers' thoughts, feelings, and behaviors before and after participating in smoking~     cessation treatment. This includes describing participants' knowledge about genetics and~     smoking, their use of strategies to stop smoking, and experiences when quitting smoking. This~     study will determine how smokers respond to information about genetics and smoking in~     anticipation of using genetic information to individualize pharmacological therapy for~     smoking cessation.~      Two groups will participate in this study. The experimental group will participate in two~     educational sessions about genetics and smoking. The control group will participate in two~     educational sessions about nutrition. Both the experimental and control groups will~     participate in a standard, group smoking cessation program with 6 weeks of OTC transdermal~     nicotine replacement therapy. Assignment to either of the two groups is random.~      The primary specific aim is to compare the effects of the experimental group to the attention~     control group on smoking-related mental representations, appraisals, behaviors, and affective~     responses over time. The secondary aim is to explore whether personality characteristics~     (trait negative affectivity and curiosity) and educational level moderate the effects of the~     genetic educational program on smoking-related mental representations, appraisals, behaviors,~     and affective responses. The hypotheses of the study are as follows:~        1. When compared to the attention control group, the experimental group will demonstrate:~             -  Smoking-Related Mental Representations:~             -  Greater knowledge of genetic contributions to smoking~             -  Greater endorsement of genetic contributions to smoking~             -  More positive attitudes towards NRT~             -  Increased abstainer and decreased smoker self-schemas~             -  Smoking-Related Appraisal: greater perceived risk for genetic predispositions to~               smoking~             -  Smoking-Related Behaviors: greater interest in genotyping.~        2. When compared to the attention control group, the experimental group will differ in:~             -  Smoking-Related Appraisals: self-efficacy for cessation and abstinence~             -  Smoking-Related Behaviors: number of quit attempts, abstinence, nicotine dependence~             -  Affective Responses: negative affect and intrusive/avoidant thoughts~   "
181740|NCT01186003|"~     The investigators anticipate that the use of Detemir will decrease the duration of an insulin~     drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit)~     length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin~     drip is discontinued.~   "
181749|NCT01185886|"~     RATIONALE: Collecting and storing samples of tumor tissue, blood, bone marrow, and other body~     fluids from patients to test in the laboratory and collecting information about the patient's~     health and treatment may help doctors learn more about cancer and help the study of cancer in~     the future. Studying these samples in the laboratory may help doctors learn more about~     changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors~     predict how patients will respond to treatment.~      PURPOSE: This research study is collecting and looking at blood and tissue samples in~     children with newly diagnosed acute lymphoblastic leukemia.~   "
181750|NCT01185873|"~     This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and~     the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and~     patients with mild, moderate or severe hepatic impairment. Participants will be administered~     repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is~     10 days.~   "
181741|NCT01185990|"~     The study is designed to identify specific patterns of brain functional activity associated~     with chronic, moderate to severe tinnitus through the use of resting-state MEG scans. Robust~     patterns identified in this study will be used as a biomarker for subsequent clinical~     evaluation of experimental drug treatments for tinnitus. This study will conduct MEG scans on~     approximately 30 to 75 subjects with tinnitus and approximately 15 healthy control subjects.~     MEG scans will be obtained for each subject following screening, clinical and tinnitus~     evaluations. A subset of 6 subjects from the tinnitus cohort will be invited to undergo~     evoked auditory assessment during an extended MEG scan session to identify cortical regions~     that respond to the auditory stimulus. These six subjects also will be evaluated with a~     single structural MRI scan to support high-resolution mapping of the localized cortical~     regions. MEG data will be analyzed to identify patterns of brain activity that are~     specifically associated with the presence of tinnitus using both standard approaches and the~     Orasi Synchronous Neural Interaction™ (SNI) test. MEG scan results also will be evaluated to~     identify specific patterns of functional activity that correlate with other measures of~     tinnitus severity such as the Iowa Tinnitus Handicap Scale. This study will test the~     hypothesis that moderate to severe tinnitus is associated with altered patterns of brain~     functional activity measured by a brief, resting-state MEG scan. This hypothesis will be~     tested by comparing resting-state MEG scans of tinnitus patients with those the of healthy~     control subjects collected during this study and available in Orasi's existing MEG scan~     database.~   "
181742|NCT01185977|"~     This study will aim to evaluate the use of Electroencephalography (EEG) biomarkers in~     adolescent depression. Two specific hypotheses will be tested:~      H1: Early decreases in prefrontal cordance values will be greater in responders to~     antidepressant therapy than in medication non-responders.~      H2: Subjects with high Antidepressant Treatment Response(ATR) Index values [i.e., predicted~     to show symptomatic improvement with fluoxetine (FLX)] will achieve greater improvement in~     symptoms and in functional status than those with low ATR values.~      Exploratory analyses will be undertaken to compare and contrast the cordance changes and ATR~     values in medication and placebo-treated responders and non-responders.~   "
181743|NCT01185964|"~     The main purpose of this study is to gather information about the use of an investigational~     drug called olaratumab with a drug for soft tissue sarcoma called doxorubicin.~   "
181744|NCT01185951|"~     Athletic tendinopathies of the upper and lower extremity are often therapeutically~     challenging. Colour and Power-Doppler-ultrasound visualizes pathological neovessels in~     painful tendons, which are associated with pain-mediating nerve fibres in such~     tendinopathies. These neovessels are represented by an increased capillary blood flow at the~     point of pain. Painful eccentric training reduces pain and improves function in Achilles~     tendinopathy substantially (evidence level Ib). Shock wave therapy in combination with~     eccentric training is superior to eccentric training alone (evidence level Ib). Long-term~     results suggest a collagen induction and reduced pain following topical glyceryl trinitrate~     (NO) (evidence level Ib). Colour- and Power-Doppler-guided sclerosing therapy using~     polidocanol reduces pain, improves function and may lead to tendon remodelling (evidence~     level Ib). Pain-restricted sport beyond pain level 5/10 during therapy is recommended~     (evidence level Ib). 3x10min of cryotherapy reduce pain and capillary blood flow (evidence~     level Ib). The role of proprioceptive training in tendinopathy has to be determined in future~     randomized-controlled trials (evidence level II).~      The investigators thought to evaluate the combination of the aforementioned individually~     successfully therapeutic options in athletes to shorten the recovery period and return to~     play interval.~   "
181745|NCT01185938|"~     This open-label study, prospective, randomized trial evaluating the acute (in-hospital)~     pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with~     acute coronary syndrome~   "
181746|NCT01185925|"~     Exercise oscillatory breathing (EOB) is a ventilatory abnormality that occurs in~     approximately 20% of heart failure (HF) patients and carries a very unfavourable prognosis.~      Pathophysiology seems quite complex and putative mechanisms include increased pulmonary~     capillary pressure and pulmonary vasoconstriction, circulatory blood-flow fluctuations in the~     pulmonary arterial system and instability of ventilatory control.~      Inhibition of the phosphodiesterase 5 (PDE5) isoenzyme favourably regulates pulmonary~     vascular tone and permeability through over signaling of the endothelial nitric oxide~     pathway. The investigators tested the hypothesis that sildenafil would reverse the EOB~     pattern in patients with HF and pulmonary hypertension.~   "
181747|NCT01185912|"~     Retrograde cardioplegia during heart surgery is associated with inadequate myocardial~     protection. In experimental animal study retrograde cardioplegia induces more cardiomyocyte~     apoptosis when compared to antegrade cardioplegia. 20 volunteer patients under going elective~     aortic valve surgery will be divided in to two groups: 10 patients receiving only antegrade~     cardioplegia and 10 patients receiving only retrograde cardioplegia. Pre- and~     post-operatively cardiac MRI and cardiac ultrasound will be performed. During the surgery~     ventricular muscle samples will be taken in order to assess cardiomyocyte apoptosis. Aims of~     the study: 1. whether the cardiomyocyte apoptosis is significantly more induced after~     retrograde cardioplegia than antegrade cardioplegia, 2. whether the amount of apoptotic~     cardiomyocytes correlates to conventional markers of myocardial injury after cardiac surgery,~     3. whether the extent of irreversible myocardial damage by apoptosis correlates to~     post-ischemic contractile dysfunction after cardiac surgery, as measured with~     echocardiography, 4. whether the amount of cardiomyocyte apoptosis correlates to long term~     outcome and cardiac function as measured with MRI.~   "
181748|NCT01185899|"~     Accurate detection of a heart attack (an acute myocardial infarction) is one of the most~     pressing needs in medicine. Recordings of the electrocardiogram (ECG) (electrical activity of~     the heart) are one of the first tools used to diagnose a heart attack, but the ECG is not~     very accurate, especially at the beginning of a heart attack. A new technique for analysing a~     special part of the ECG may provide more accurate detection of a heart attack. The study~     hypothesis is that this new technique, the HFQRS analysis, will provide important additional~     information to that available from the regular ECG.~   "
181873|NCT01184261|"~     RATIONALE: Nicotine patches and behavioral therapy may help reduce cigarette smoking and~     binge drinking in young adults. PURPOSE: This randomized clinical trial studies nicotine~     patches with or without behavioral therapy in reducing cigarette smoking and binge drinking~     in young adults.~   "
181751|NCT01185860|"~     This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus~     ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic~     hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in~     cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus~     ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once~     weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after~     completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.~   "
181752|NCT01185847|"~     This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in~     combination with standard chemotherapy in patients with advanced or recurrent non-small cell~     lung cancer who have not received prior chemotherapy. In Part 1 patients will receive~     RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or~     pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In~     Part 2 patients will be randomized to receive either RO5083945 in combination with standard~     chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression,~     patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.~   "
181753|NCT01185834|"~     The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact~     lens.~   "
181754|NCT01185821|"~     This study consisted of a two year dose blinded phase during which patients received one of~     five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched~     to open label treatment with siponimod 2mg for approximately a further 3 years. It will~     provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient~     population~   "
181755|NCT01185808|"~     The purpose of this study is to determine if Vitamin D supplementation improves clinical and~     immunologic parameters in chronic rhinosinusitis with nasal polyps.~   "
181756|NCT01185795|"~     Background: Several studies have reported limited or no reduction in serum lipid~     concentrations in response to probiotic formulations. More recently, probiotics have shown~     promise in treating metabolic disease, due to improved strain selection and delivery~     technologies.~      Objective: To evaluate the lipid lowering efficacy of a yogurt formulation containing~     microencapsulated Bile Salt Hydrolase (BSH)-active Lactobacillus reuteri cardioviva, taken~     twice per day over 6 weeks, in subjects with hypercholesterolemia.~      Design: This is a double-blinded, multi-centric, placebo-controlled, randomized, parallel-arm~     study. The study will last a total of 10 weeks including 2-week wash-out, 2-week run-in, and~     6- week treatment period.~   "
181757|NCT01185782|"~     Efficacy and safety studies in the past have suggested that a starting dose of 75~     International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are~     safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic~     or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including~     oligomenorrhea and polymenorrhea).~      This was a phase III, multicentre, single-blind, parallel-group comparative study conducted~     to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin,~     a comparator drug, for induction of follicle development and ovulation in infertile Japanese~     women and to provide further information on the safety and tolerability of SJ-0021.~   "
181758|NCT01185769|"~     Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans~     remains unclear especially with different fat diets.This study aimed at evaluating the~     absorption and distribution of tocotrienols in plasma and lipoproteins in associations with~     high and low fat diets. Different fat level will affect the absorption and distribution of~     tocotrienols~   "
181759|NCT01185756|"~     The aim of the study is to assess the cardiac innervation in patients with heart failure to~     better select candidates for an implantable cardioverter defibrillator. Cardiac innervation~     will be assessed using an imaging agent administered intravenously.~   "
181760|NCT01185743|"~     Schizophrenia is a severe chronic and disabling mental disorder and is associated with a~     significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be~     jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid~     metabolism.~      Aim: to gain data on drug related effects on gene expression and regulation with special~     regard to glucose metabolism.~   "
181761|NCT01185730|"~     The objective of this clinical research is to analyze the survival of a cohort of patients~     newly diagnosed (incident cases) with idiopathic PAH, familial or associated with the use of~     anorectics (isolated pulmonary vascular disease without comorbidity) and identify prognostic~     factors using a dynamic model for predicting survival, including prognostic factors evaluated~     repeatedly at pre-specified periods during follow-up. In a second step, the investigators~     define using this model combinations of parameters to better define the therapeutic goals in~     PAH (functional class, exercise testing, hemodynamic, echocardiographic variables, biological~     parameters).~   "
181762|NCT01185717|"~     The objective of the study is to estimate the prevalence of anti-JCV antibodies in multiple~     sclerosis (MS) participants.~   "
181763|NCT01185704|"~     This is a randomized open-label study to compare between in-vitro~     fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of~     Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the~     menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted~     reproductive technology (ART).~   "
181764|NCT01185691|"~     The primary objective of this study is to assess safety and feasibility of IMPELLA 2.5 in~     Acute Decompensated Heart Failure patients.~   "
181765|NCT01185678|"~     Adherence to the dosing scheme is the principal element of COC efficiency. On the other hand~     noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study~     is to evaluate in everyday practice the relation between dosage errors and indicated factors,~     potentially influencing the compliance with the dosing scheme.~   "
181766|NCT01185665|"~     The study investigates the feasibility and efficacy of Transcutaneous Electrical Nerve~     Stimulator (TENS) in a subgroup of patients with neuropathic pain. Those patients are~     suffering of neuropathic pain at the lower back and leg after spinal surgery with a~     predominance of pain in the leg.~   "
181899|NCT01183910|"~     A randomized, double-blind, placebo controlled study to assess the safety and effectiveness~     of a novel oral natural extract to improve the appearance of the skin of patients with senile~     purpura.~   "
181767|NCT01185652|"~     Tobacco-smoking causes lung function decline with airflow obstruction, which may be~     accelerated in persistent smokers.This would eventually lead to chronic obstructive pulmonary~     disease (COPD), a leading cause of morbidity and mortality in Hong Kong and globally. Lung~     function decline is gradual and not appreciated by the smoker until damage is advanced, and~     often under-recognised in the early stages of disease by healthcare providers. Spirometry is~     an established lung function measurement tool, and the most simple objective method to detect~     lung function decline. There is literature suggesting that newer spirometric parameters, FEV3~     and FEV6, which are easier to achieve in the measurement process than conventional~     parameters, are comparable alternatives in detecting lung function decline.~      The aims of this study are:~        1. to evaluate and compare lung function decline in persistent smokers and non-smokers~        2. to study the usefulness of FEV3/FVC and FEV1/FEV6 in detecting lung function decline~        3. to correlate symptom scores with lung function parameters~        4. To correlate serum biomarker levels with respiratory symptoms and lung function~          parameters in smokers and non-smokers~      This is a follow-up study on a territory wide cohort including smokers and non-smokers, who~     have undergone lung function testing in 2001-03. Subjects will be invited to have repeat lung~     function assessment.~      The hypotheses of this study are:~        1. smokers have significantly greater decline in lung function compared to non-smokers in~          Hong Kong Chinese;~        2. newer lung function parameters are useful alternatives in detecting lung function~          decline~        3. serum inflammatory biomarker (IL-8, TGF-β, MMP9, TIMP-1, CRP) levels correlate with~          respiratory symptoms and lung function parameters in smokers when compared with~          non-smokers~   "
181768|NCT01185639|"~     This protocol is a single arm phase II multi-center trial evaluating the efficacy of~     Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell~     lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line~     chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line~     chemotherapy is feasible, safe, provides durable local control of treated lesions and~     improves time to progression compared to historical controls. Patients are eligible for~     enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.~   "
181769|NCT01185626|"~     Earlier diagnoses and improved treatments have contributed to the growing cohort of cancer~     survivors. Nevertheless, these patients remain at risk for adverse long-term or late physical~     or psychosocial effects of cancer and its treatment. There is increasing recognition to~     improve information disclosure and cancer survivorship care. The American Institute of~     Medicine (IOM) and Health Council of the Netherlands both recommend that cancer survivors~     receive a summary of their course of treatment as a formal document, that also includes~     recommendations for subsequent cancer surveillance, management of late effects, and~     strategies for health promotion, the Survivorship Care Plan (SCP). However, no evidence~     exists concerning the positive and negative effects of the implementation of the SCP in daily~     clinical practice. The purpose of this study is to assess the impact of SCP care in routine~     clinical practice on cancer survivors' satisfaction with information disclosure and care,~     quality of life, illness perception, and health care use.~   "
181770|NCT01185613|"~     The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by~     documenting the procedural parameters, major complications and recurrence of AF after~     ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial~     fibrillation.~      This study is an observational clinical study which is not based on any specific endpoints.~   "
181771|NCT01185600|"~     INTRODUCTION. Cell-derived microparticles (MP) are released in cell activation, apoptosis and~     other processes. MP derived from red cells (RMP) are known to be released from stored packed~     red blood cells (PRBC), and their number increases with storage time. This constitutes one~     aspect of the storage lesion. Adverse transfusion events are known to increase with time of~     PRBC storage. The explanation for this is not known.~      HYPOTHESIS. Based on their findings and those of others, the investigators propose to test~     the hypothesis that MP in stored PRBC contribute to adverse effects of transfusion.~     Specifically, MP in stored blood: (1) increase procoagulant activity, expression of~     pro-inflammatory mediators, immune suppression, and endothelial disturbance; and (2) increase~     the risk of transfusion and post-operative complications in patients undergoing coronary~     artery bypass grafting (CABG).~      AIMS & PROCEDURES. The aim of this study is to assess the clinical significance of MPs in~     PRBC-related transfusion complications utilizing washed PRBC. Packed red blood cells (PRBC)~     will be washed at the blood bank to obtain MP depleted PRBC (PRBC-MP). A total of 500~     patients undergoing CABG will be initially randomized to 2 groups: one to receive PRBC-MP,~     and the other conventional PRBC (PRBC+MP). Using a panel of lab tests/biomarkers selected for~     high sensitivity the investigators will compare the 2 groups with respect to subclinical~     physiologic host responses including (i) endothelial disturbances, (ii) inflammatory, and~     (iii) procoagulant responses. In addition, clinically evident transfusion complications and~     short term (<=30 days) surgical complications will be assessed and compared. Patients who are~     randomized but end up not requiring transfusion at surgery will serve as controls. Laboratory~     and clinical results will also be evaluated to elucidate which tests are significantly~     associated with clinically adverse effects.~      SIGNIFICANCE. This study will shed new light on the biochemical and clinical effects of~     transfusion of MP. The findings of this investigation could significantly improve transfusion~     practice and safety.~   "
181772|NCT01185587|"~     The purpose of this research is to see if investigators can detect truncated mRNA splice~     variants of the cardiac voltage-gated sodium (Na+) channel gene, SCN5A, in patients with a~     weak heart (Heart Failure) with or without an implantable cardioverter-defibrillator (ICD)~     and compare them to patients with a normal heart.~      Hypothesis:~        1. Patients with reduced left ventricular ejection fraction have increased abundances~          truncated mRNA splice variants of the SCN5A gene, which portends to sodium channel~          dysfunction and an increased risk for sudden cardiac death.~        2. Patients with implantable cardioverter-defibrillator devices (ICDs) who have experienced~          shock therapy have increased abundances of truncated mRNA splice variants of the SCN5A~          gene compared to similar congestive heart failure patients who have not experienced~          shock therapy.~   "
181773|NCT01185574|"~     This study will examine whether weekly vitamin D supplementation in women with significant~     depressive symptoms and diabetes will exhibit improved mood and metabolic control. If~     supplementation with Vitamin D is beneficial, it will be a simple and cost-effective method~     for treatment. Women will be targeted since they have greater depression and worse metabolic~     control than men with diabetes.~   "
181774|NCT01185561|"~     This proposal describes a small randomized study to determine whether usual medical care~     (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for~     diabetes alone. This program differs from other diabetes programs by focusing on the~     management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes~     self-care behaviors will be discussed and measured, but they are not the primary focus of the~     intervention. The psychoeducational program will address: 1) education about how dysphoric~     symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of~     dysphoric symptoms using Cognitive Behavioral Therapy (CBT). Subjects will be randomized to~     receive the group psychoeducational intervention or no additional treatment. All subjects~     will receive UMC for diabetes.~   "
181775|NCT01185548|"~     The purpose of this study is to assess the effect of tasisulam as an inhibitor of CYP2C9,~     using tolbutamide as a probe substrate. This study is comprised of three treatment periods,~     and continued access in an extension period. Period 1 is 4 days in length. Periods 2 and 3~     are approximately 28 days in length.~   "
181900|NCT01183897|"~     The purpose of this study is to see find out what effects, good and/or bad, the combination~     of 3F8 and GM-CSF has on the patient and the cancer.~   "
181776|NCT01185535|"~     As reported, about 0.43% patients can not be intubated unevenly because of difficult airway~     and 30% of the total death of anesthesia due to failed intubation. The difficult airway will~     disturb the clinical treatment and even threaten the patients' life. But the present methods~     for tracheal intubation during awake intubation can not provided ideal intubation condition.~     In this study, the investigators will perform topical anesthesia with the nebulized 2%~     lidocaine at 10L/min oxygen flow rate, and the observer's assessment of alert and sedation~     (OAA/S) scale was controlled to 3-4 points by intravenous midazolam,propofol, and~     remifentanil. Tracheal intubation was performed after topical anesthesia. The arterial~     pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood~     samples were taken to measure stress factor during intubation period.Intubation condition~     score was assessed and the complications like local anesthetic toxicity, mucosa injury,~     respiration depress were also recorded. Patients were asked whether they could recall the~     events during intubation 24 hr after operation. The investigators aim is to evaluate the~     effect of topical anesthesia with lidocaine nebulized by 10L/min oxygen flow rate during~     awake tracheal intubation.~   "
181777|NCT01185522|"~     This prospective, observational study will assess the effect of RoActemra/Actemra~     (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthritis who have an~     inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti tumor necrosis~     factor (anti-TNF) drugs. Eligible patients receiving RoActemra/Actemra according to the~     standard of care will be followed for 4 months.~   "
181778|NCT01185509|"~     The purpose of this research study is to see what effects trastuzumab in combination with~     vinorelbine has on breast cancer when the participant has circulating tumor cells that are~     positive for the protein called HER2. Trastuzumab is an FDA approved drug that targets HER2.~     The drug combination of trastuzumab and vinorelbine is an effective treatment for patients~     with breast cancers that are positive for HER2. This trial seeks to determine if the~     combination can also benefit participants whose original breast cancer was HER2 negative but~     whose circulating tumor cells are HER2 positive.~   "
181779|NCT01185496|"~     The purpose of this study is to evaluate the safety and effectiveness of the G4 System when~     worn for up to 7-days by children and adolescent subjects (6 to <18 years-old) with type 1~     diabetes mellitus.~   "
181780|NCT01185483|"~     Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of~     superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of~     submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a~     high degree of endoscopic skills to be performed safely, it is time consuming, and less safe~     than endoscopic mucosa resection.~      New endoscopic instruments have been developed to increase the efficacy and safety of ESD,~     and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with~     promising results in animal studies. This HybridKnife allows high-pressure water-jet~     (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without~     changing instrument.~      The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for~     ESD in humans.~   "
181781|NCT01185470|"~     • The objectives of this study are to confirm the medication delivery accuracy of the~     Infusion System, LLC Implantable Drug Delivery System (IDDS) with Patient Controlled~     Analgesia for intrathecal delivery of morphine sulfate for pain control, and to determine the~     safety profile of the system with PCA for intrathecal delivery of morphine sulfate for pain~     control.~   "
181782|NCT01185457|"~     The Left interscalene block has a different effect on heart's autonomic nervous system, as~     measured with Heart Rate Variability, compared to Right interscalene block~   "
181783|NCT01185444|"~     Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide rapid~     pain relief as early as 1 and 2 weeks after the first injection, and improve function in~     patients with knee osteoarthritis. The treatment effects can last for 6 months.~   "
181784|NCT01185431|"~     This trial is being conducted to look for following changes when fig paste is taken by female~     subjects with functional constipation:~      To evaluate the improvement of the bowel~      To assess the quality of life and impact on female reproductive function~      To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol~   "
181785|NCT01185418|"~     The aim of the study is to investigate the negative symptoms and cognitive function after~     administration of antipsychotics in healthy volunteer.~   "
181786|NCT01185405|"~     Voriconazole, a newer triazole-derivative, has become the drug of choice for many invasive~     fungal infections, including invasive Aspergillosis. Recently, therapeutic drug monitoring of~     voriconazole has been issued because of wide variations and unpredictability of voriconazole~     blood concentration. The objective of this study is 1) to characterize the pharmacokinetics~     of voriconazole in ICU patients on voriconazole prophylaxis or treatment, and 2) to develop~     and evaluate the prediction and adjustment models for voriconazole plasma levels.~   "
181787|NCT01185392|"~     The European CRT survey represents a joint initiative between two ESC associations; the Heart~     Failure Association and the European Heart Rhythm Association. The survey will be performed~     in collaboration with The Institute für Herzinfarktforschung in Ludwigshafen which will~     handle the data collection and data analysis.~   "
181801|NCT01185210|"~     Background:~      Over the past few decades, fructose is increasingly being used as a sweetener/ additive in a~     variety of foods. Incomplete absorption of fructose has been implicated as a cause of~     gastrointestinal symptoms. In tertiary care centers, the prevalence of fructose malabsorption~     in subjects with unexplained GI symptoms is thought to be between 11-50%, when assessed with~     breath tests following administration of 25 grams of fructose in a 10% solution. Restriction~     of dietary fructose has been shown to improve symptoms in these patients to an extent.~     Currently, there are no therapeutic agents that improve intestinal fructose absorption and~     thereby decrease symptoms. Studies in the pediatric population have shown that fructose~     absorption in the small intestine is increased in the presence of glucose or amino acids,~     especially alanine.~      Objective:~      The investigators' objective is to assess whether co-administration of an oral solution of~     L-alanine facilitates fructose absorption and decreases gastrointestinal (GI) symptoms~     associated with fructose malabsorption in subjects undergoing standard fructose breath test~     when compared to placebo.~      Methods and analysis:~      The investigators propose a randomized, double-blind study in 40 subjects with known fructose~     intolerance. After an overnight fast, each subject will receive an oral solution of 12.5~     grams of alanine in 125cc of water or placebo. Next, the subject will receive an oral~     solution of 25 grams of fructose in a 10% solution. Serum, urine and breath samples will be~     collected at baseline and at 30-minute intervals for 4 hours. GI symptoms will also be~     assessed and recorded at 30 minute intervals using a standard questionnaire. Repeated~     measures ANOVA will be used to compare the data obtained during the study protocol with the~     baseline (pre-study) data.~      Expected outcomes:~      Co-administration of alanine with fructose may improve fructose absorption and decrease~     symptoms in subjects with fructose intolerance.~      Hypothesis: Ingestion of alanine along with fructose, will facilitate intestinal absorption~     of fructose in subjects with fructose malabsorption.~      Aim: To investigate the effects of co-administration of equi-molar doses of alanine on a) the~     absorption of fructose and b) the occurrence of GI symptoms in subjects with fructose~     malabsorption.~   "
181788|NCT01185379|"~     Dietary intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs) is inversely associated~     with cognitive decline and dementia (e.g. Kalmijn et al. 2004, Heude et al. 2003, Morris et~     al. 2005, Dullemeijer et al. 2009). Recently, the effects of supplemental docosahexaenoic~     acid (DHA) on behavioural outcomes in older adults has been explored, however two trials~     addressing this issue have published conflicting results regarding the efficacy of DHA~     supplementation, with one reporting a benefit of treatment on cognitive performance~     (Yurko-Mauro et al. 2010), while the other did not (Dangour et al. 2010).~      One area of research that has yet to be explored in this cohort is the effects of n-3 PUFAs~     on brain function in physiological terms. It is also possible that n-3 PUFAs, in combination~     with other compounds, may be more beneficial than treatment with n-3 PUFAs in isolation. The~     current study will explore several separate hypotheses within the same cohort. These are that~     Efalex Active 50+ may have a beneficial effect on:~        -  Cognitive performance~        -  Mental fatigue in response to cognitively demanding tasks~        -  Self-reported mood/well-being~        -  Task-related cerebral blood flow response~      The proposed study therefore has two aims; the primary aim is to evaluate the cognitive and~     mood/well-being effects of Efalex Active 50+, a dietary supplement containing a number of~     potentially cognition enhancing components including DHA, phosphatidylserine, vitamin B12,~     folic acid and Ginkgo biloba, compared with placebo in a sample of older adults aged 50-70~     years (Cognitive Study). The second is to evaluate the cerebral haemodynamic effects of the~     same treatment formulation in a sample drawn from the same population, with the addition of a~     third DHA-only arm (Hemodynamics Study). The intervention period will be 6 months.~   "
181789|NCT01185366|"~     The goal of this clinical research study is to compare the effectiveness of Afinitor~     (everolimus) and Sutent (sunitinib) for the treatment of advanced renal cell carcinoma~     (kidney cancer). The safety of each treatment will also be studied.~   "
181790|NCT01185353|"~     The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants~     with Rheumatoid Arthritis (RA).~   "
181791|NCT01185340|"~     The primary objective of this study is to assess whether LY2216684 12 milligrams (mg) or 18~     mg flexible dose once daily is superior to placebo once daily in the adjunctive treatment of~     participants with major depressive disorder (MDD) who are partial responders to their~     selective serotonin reuptake inhibitor (SSRI) treatment.~   "
181792|NCT01185327|"~     Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have~     noticed that infant of Ethiopian-origin mothers regurgitate more than other infants.~     Probably, these infants are breastfeed much more than other infants.~      Some Ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of~     pregnancy and after birth, in order to expand milk production.~      Study goal is to find out if infants of Ethiopian-origin mother do regurgitate more than~     others, and if they weight gain is similar to other infants. Another goal is to find out if~     breastfeeding mothers of Ethiopian origin do eat that porridge, and if there is any~     difference between those who do eat that porridge and those who do not.~   "
181793|NCT01185314|"~     The purpose of this study is to study the changes in protein in lung cells of Asian patients~     with advanced non small cell lung cancer.~   "
181794|NCT01185301|"~     The purpose of this study is to determine the effects of different doses of methotrexate~     (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).~   "
181795|NCT01185288|"~     This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in~     combination with open-label adalimumab (ADA) in patients who have had an inadequate response~     to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two~     regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).~   "
181796|NCT01185275|"~     Clinical response, as defined by improvement in asthma quality of life, to bronchial~     thermoplasty in patients with severe refractory asthma can be predicted through the use of~     clinical, physiologic, biologic and imaging markers.~   "
181797|NCT01185262|"~     The rationale for combining lenalidomide with rituximab derives from preclinical observations~     suggesting that lenalidomide may enhance the ADCC (antigen-dependent cellular cytotoxicity)~     triggered by monoclonal antibodies such as rituximab. Lenalidomide augments NK cytotoxicity~     by increasing CD56dimCD3 subset, in addition to inducing IL-2 in T cells. These results~     provide the cellular and molecular basis for the use of lenalidomide as an adjuvant in~     immunotherapeutic strategies of monoclonal antibodies (mAb)-based therapies. The combination~     lenalidomide-rituximab was tested in lymphoma cell lines but not specifically on CLL cell~     lines. However the observed synergism was attributed to NK cells expansion, thus lending~     support to the notion that this synergism may operate in other B-cell lymphoproliferative~     malignancies.~      The objective was to develop a non-cytotoxic and effective treatment for CLL that would~     fulfill an unmet medical need, as a significant proportion of CLL patients are elderly and~     frail. These patients experience an excess in chemotherapy induced toxicity, often preventing~     the completion of the planned treatment.~   "
181798|NCT01185249|"~     Early morning weights to monitor CHF patient's fluid status is common practice but there is a~     lack of evidence that this is the best practice. The purpose of this study is to determine if~     there is a difference in net weight gain or loss for hospitalized patients with CHF who are~     weighed in the evening instead of early morning.~   "
181799|NCT01185236|"~     A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin~     10/20mg vs atorvastatin 20mg treatment.~      DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be~     randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout~     or TLC period. Primary and secondary endpoints will be assessed at week 12.~      Primary endpoint:~      1) change of ApoB/ApoA ratio at week 12.~      Secondary endpoint:~        1. Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.~        2. Change of HbA1C at week 12.~        3. Change of HOMA index at week 12~           - HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5~        4. Change of hsCRP at week 12~        5. Safety assessment~      Hypotheses:~        -  Three months treatment of Vytorin 10/20mg will be superior to atorvastatin 20mg in~          ApoB/ApoA ratio.~        -  In DM patients, Ezetimibe/Simvastatin Combination will be well-tolerated.~   "
181800|NCT01185223|"~     The objective of this study is to assess the efficacy and safety of oral valganciclovir~     versus intravenous ganciclovir in patients following allogenic stem cell transplantation.~   "
181808|NCT01185119|"~     10 healthy men will be PET-scanned (CNS) twice in random order with infusions of placebo or~     Native GLP-1 during hyperglycemic clamp to uncover the metabolic effects of GLP-1 in~     perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI.~     Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite~     fluctuations in blood sugar when infusing native GLP-1.~   "
181809|NCT01185093|"~     The main objectives of the study is to~        -  Evaluate the knowledge acquisition and retention of 4th-grade students who participate~          in the St. Jude Cancer Education for Children Program~        -  To examine the relationship between outcome measures (knowledge acquisition and~          knowledge retention) with covariates of interest such as self-reported age and gender~        -  To compare the knowledge scores among schools and identify the schools that may show~          better improvement than others and factors associated with improvement~   "
181810|NCT01185080|"~     The primary purpose of this study is to investigate effect, tolerability and safety of~     different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis~     patients out of season in an allergen challenge model.~   "
181811|NCT01185067|"~     Diastolic heart failure (also known as heart failure with normal ejection fraction or~     heart failure with preserved ejection fraction) occurs even though the heart muscle's~     pumping function is normal. In many cases diastolic heart failure is related to stiffening of~     the heart and blood vessels in people who have high blood pressure. Current guidelines~     suggest that patients should limit the salt content of their diet, as too much salty food can~     cause fluid retention and other problems in diastolic heart failure. Studies in animals with~     diastolic heart failure suggest that antioxidant chemicals found in grapes can block some of~     the harmful effects of salty diets. Because it is often difficult for patients with diastolic~     heart failure to maintain a low salt diet, the investigators are researching the effects of~     the antioxidant properties of grape seed extract, a natural supplement made from grape seeds.~     The investigators hypothesize that supplementing the diet with grape seed extract (GSE) can~     decrease the levels of harmful chemicals and improve heart and blood vessel function in~     patients with diastolic heart failure and a history of high blood pressure.~      The University of Michigan research group plans to enroll 25 patients with a history of high~     blood pressure and diastolic heart failure in a research study. The study will assess the~     effects of GSE on hormones and other chemicals that can cause heart and blood vessel damage.~     The investigators will also study the effects of GSE on the ability of the blood vessels and~     heart muscles to relax at the proper time and speed. Finally, the investigators will observe~     how GSE affects participants' overall ability to exercise, quality of life, and blood~     pressure control. Study participants will be randomly assigned to take either GSE or placebo~     (looks like but does not contain GSE) capsules twice a day for six weeks. After a two-week~     break, all subjects will cross over to the opposite group of capsules for an additional~     six-week period. At the start of the study and at the end of each six-week time period study~     participants will have non-invasive heart and blood vessel testing, blood work and urine~     tests, and blood pressure monitoring.~   "
181812|NCT01185054|"~     The objective of this study is to clarify the current standard of care by determining if~     Electrolyte Maintenance Solution (EMS) is truly the optimal fluid to be used in low-risk~     children who present to an Emergency Department (ED) with < 72 hours of vomiting or diarrhea.~   "
181813|NCT01185041|"~     Increased abdominal obesity (waist circumference) and systolic blood pressure (BP) are main~     risk factors for the metabolic syndrome. Approximately 60% of adults in the United States are~     prehypertensive or hypertensive. Hypertension has been associated with abnormal endothelial~     and autonomic function, the two main mechanisms of BP regulation. Endothelial dysfunction, as~     a result of reduced NO (a vasodilator), and increased sympathetic nervous system activity~     contribute to arterial stiffness by enhancing the vasomotor tone. Because BP variations are~     sensed by baroreceptors in the wall of large arteries, increased stiffness of arteries may~     attenuate the control of BP by the autonomic nervous system leading to hypertension. High~     production of proinflammatory cytokines and low adiponectin (vascular protective molecule),~     are considered the underlying mechanisms leading to endothelial dysfunction and arterial~     stiffness. The recommended intervention for controlling BP in overweight/obese individuals~     with pre- and stage 1- hypertension is lifestyle modifications and not drug therapy. Among~     the dietary regimens that are reported to reduce BP is L-arginine, the substrate for~     endothelial NO production. Recently, oral L-citrulline has been shown to be more effective~     than L-arginine in improving circulating NO levels because is not affected by enzymatic~     degradation. Watermelon, the leading US melon crop, is one of the few natural foods rich in~     L-citrulline which is efficiently transformed to arginine in humans. The investigators~     long-term goal is to provide feasible and effective dietary ways to reduce cardiovascular~     risk factors in individuals with high abdominal fat and BP. The overall objective of this~     study is to bring forth evidence that watermelon supplementation will reduce BP and~     cardiovascular risk factors such as arterial stiffness, autonomic dysfunction and endothelial~     dysfunction. The investigators postulate that watermelon supplementation will reduce BP and~     arterial stiffness by enhancing endothelial function and reducing vascular inflammation. The~     findings of this study will provide a foundation for disseminating feasible, safe approaches~     for preventing and combating obesity-related hypertension at its early stage which does not~     require drug therapy.~   "
181814|NCT01185028|"~     Background:~        -  Chronic hepatitis C (CHC) is a major health problem that particularly affects~          individuals with human immunodeficiency virus (HIV) infection, and can lead to cirrhosis~          and liver failure. Standard treatment for people with HIV and CHC is a 48-week course of~          pegylated-interferon alfa 2a (peg-IFN) and ribavirin (RBV), but better treatments are~          needed for those who either do not respond to the drugs or who relapse after treatment.~        -  Nitazoxanide has been approved by the Food and Drug Administration primarily to treat~          diarrhea caused by parasites, and it has been studied in the treatment of CHC infection.~          However, it has not been tested in persons infected with HIV and CHC co-infection.~          Researchers are interested in determining whether nitazoxanide is a safe and tolerable~          treatment for CHC in individuals with HIV.~      Objectives:~      - To assess the safety and tolerability of using nitazoxanide to treat chronic hepatitis C~     infection in individuals with HIV who have not responded to standard treatment for hepatitis~     C.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with both HIV and chronic~     hepatitis C, and who have either not responded to or relapsed after previous hepatitis C~     treatment.~      Design:~        -  Participants will be screened with a physical examination and medical history; blood and~          urine tests; imaging studies; possible heart, lung, and psychological tests; and a liver~          biopsy if one has not been done in the past 3 years.~        -  Participants will receive nitazoxanide, the medication being studied, to take by mouth~          for 4 weeks, and will provide blood samples during this time.~        -  After 4 weeks, participants will receive the first dose of peg-IFN and RBV. Participants~          will have weekly injections of peg-IFN and continue to take nitazoxanide and RBV by~          mouth for 48 weeks. Individuals who are slow to respond to this combined CHC treatment~          (nitazoxanide, peg-IFN, and RBV) by week 12 will continue to have the combined treatment~          for an extended period, a total of 72 weeks.~        -  Participants will have study visits to provide blood samples and have other tests two~          times in the first month of combined treatment, and then at months 2, 3, 4, 7, 10, 13,~          19; and month 25 only in participants slow to respond to combined treatment.~        -  Some participants who are on specific HIV treatment regimens may enroll in a substudy~          that will require three separate 12-hour visits for repeated blood samples and other~          tests during the initial 4-week nitazoxanide treatment.~   "
181815|NCT01185015|"~     The multi-centric, open label, single arm and self controlled study is planned to assess the~     efficacy of orally administered Sigmart in subjects with recurrent angina after coronary~     revascularization. The primary objective of this study is to demonstrate that orally~     administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent~     angina subjects.~   "
181816|NCT01185002|"~     The purpose of the study is to test the effect of a bowel preparation and boosts regimen on~     PillCam® procedure, colon cleanliness and capsule excretion time.~   "
181817|NCT01184989|"~     To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on~     coagulation parameters, including a calibrated thrombin time test, in patients with moderate~     renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study~     will be conducted.~   "
181818|NCT01184976|"~     Research Hypothesis: VGX-3400 (DNA plasmids encoding the hemagglutinin (HA), neuraminidase~     (NA), and M2e-NP antigen of the H5N1 avian influenza virus) administered to healthy adult~     males by IM injection followed by EP will be generally well tolerated and immunogenic.~   "
181901|NCT01183884|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     3F8 and GM-CSF has on the patient and the cancer.~   "
181819|NCT01184963|"~     The objective of this study is to assess the effects of a high protein (HP) and a normal~     protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index~     (BMI)-matched controls in a sample of southern Brazilian women.~      Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30%~     lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.~      The investigators hypothesis is that a different diet composition may have influences in~     changes of the main characteristics of PCOS, like hyperandrogenism and metabolic syndrome.~   "
181820|NCT01184950|"~     The use of virtual reality simulation training in obstetrics and gynecology has not been~     widely studied. The investigators hypothesized that residents randomized to the trainer would~     not perform differently when compared with those who are not randomized. Residents in~     Obstetrics and gynecology are randomized to a 4 month training course on our simulator. They~     are objectively evaluated performing various laparoscopy tasks prior to and after the course.~   "
181821|NCT01184937|"~     For patients with end-stage kidney disease, transplantation is the treatment of choice,~     offering improved quality of life by restored metabolism and freedom from dialysis. However,~     demands regarding the acquirement of knowledge in life post transplantation are high. In~     order to reduce rejection episodes, graft loss and the negative consequences of life-long~     immunosuppressive medication, it is essential for kidney recipients to possess knowledge~     about important aspects regarding immunosuppressive medication, graft surveillance and the~     benefit of specific lifestyle behavior. Consequently, patient education is required for this~     patient group. This randomized controlled trial is investigating the effect of a structured~     patient education program on kidney recipients' knowledge, coping and quality of life~   "
181822|NCT01184924|"~     The primary goal of this study is to assess the effectiveness and feasibility of the~     arthritis foundation (AF) Tai Chi Program for People with Arthritis. Arthritis, the most~     prevalent chronic condition in the US and a leading cause of disability, is characterized by~     chronic pain and progressive impairment of joints and soft tissues. Promoting physical~     activity is a key public health strategy to addressing arthritis management, but more~     scientific data regarding effectiveness and feasibility are need to support the promotion of~     the AF Tai Chi Program as an exercise intervention for people with arthritis.~   "
181823|NCT01184911|"~     The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in~     pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by~     increased SP resistance. This study will evaluate the efficacy of SP by giving SP to~     asymptomatic parasitemic pregnant women and following them to determine the rates of parasite~     clearance.~   "
181824|NCT01184898|"~     The purpose of this study is to evaluate the addition of Sirolimus (rapamycin) to standard~     chemotherapy for the treatment of patients with high risk acute myelogenous leukemia (AML).~     Cancer cells taken from the patients will be studied in the laboratory to see if rapamycin is~     affecting the mTOR pathway in the cells and if this effect is correlated with how well~     patients respond to the therapy.~   "
181825|NCT01184885|"~     This is a pilot study, assessing the feasibility, safety and toxicity of an mTOR (mammalian~     target of Rapamycin) inhibitor (MTI), rapamycin, when administered with HyperCVAD~     (Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicine and Dexamethasone), with an~     ultimate goal to perform a phase II study to evaluate response rates and survival in adults~     with Acute Lymphoblastic Leukemia (ALL) and aggressive lymphoid malignancies.~   "
181826|NCT01184872|"~     The purpose of this study is to provide data documenting the efficacy of daptomycin in~     elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.~   "
181827|NCT01184859|"~     This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group~     comparative trial to be conducted in nocturia patients. The trial is designed to characterize~     the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct~     dose recommendations in the target patient population. In particular, the trial is designed~     to link the duration of action to the clinical endpoint. Furthermore, the trial is designed~     to describe the safety of four different dose levels of desmopressin.~   "
181828|NCT01184846|"~     The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects~     with CIDP.~   "
181829|NCT01184833|"~     Non-adherence to the treatment regimen is a common problem associated with injectable drugs~     (e.g. Betaferon) that are used in multiple sclerosis patients.~      Certain patients omit single injections or even totally discontinue therapy that normally~     should be long-term. It is therefore crucial to identify the factors which have the most~     significant effect on regularity of administration of Betaferon and the risk of premature~     discontinuation of treatment in order to undertake appropriate preventive measures.~      This study is conducted in routine practice setting and aims to identify those risks.~     Pre-defined risk factors associated with technical aspects of the treatment, support provided~     to the patient, stage of the disease and possible adverse effects of the medication are~     checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the~     prescribed medication (Betaferon) is carried out by the study nurse.~   "
181830|NCT01184820|"~     The purpose of this study is to describe the pharmacokinetics (PK) of BAY94-9027(the test~     drug). Pharmacokinetics means that we will measure how well the study drug corrects the~     factor VIII levels in your blood and how long it takes for the levels to fall back to your~     baseline level. The study is also designed to determine if the pharmacokinetics of BAY94-9027~     change following repeat dosing over 8 weeks, determine if BAY94-9027 is safe, tolerable, and~     effective for the treatment of severe hemophilia A and define the appropriate dose of~     BAY94-9027. Two doses of BAY94-9027 will be studied.~      The first 8 subjects enrolled in the study (cohort 1) will receive a low dose (25 IU/kg) and~     will be treated 2 days a week for 8 weeks (total of 16 doses). The second 8 subjects (cohort~     2) will receive a higher dose and will be treated 1 day a week for 8 weeks (total 8 doses).~     All subjects will receive a single dose of rFVIII (Bayer Kogenate FS) to determine the PK by~     measuring blood levels for 2 days before they start the study drug BAY94-9027. Factor VIII~     blood levels for BAY94-9027 will be measured for 7 days after the first and last dose to see~     describe the PK. Safety & tolerability assessment include vital signs, coagulation and~     hematological parameter, clinical chemistry, measurement of FVIII inhibitor and polyethylene~     glycol (PEG) antibodies will be done during the course of the study.~   "
181831|NCT01184807|"~     This is an open-label, non-randomized, dose-escalation trial in patients with advanced solid~     tumors. The trial comprises 2 stages: a dose escalation stage at 8 dose levels of 2, 5, 10,~     20, 40, 60, 80, and 100 mg/day,and possibly additional intermediate doses, to determine the~     MTD and recommended dose, and a subsequent 2 parts of expansion stage to investigate the~     safety profile and antitumor effect of OPB-51602 at the recommended dose.~   "
181832|NCT01184794|"~     This study is a blinded randomised study of slow release levobupivacaine vs saline for women~     undergoing day case operative pelvic laparoscopy. Participants will be randomly given either~     saline or levobupivacaine and efficacy will be measured using ranked ordinal pain scales and~     rescue oral analgesia use.~   "
181833|NCT01184781|"~     The aim of the study is to perform a prospective, multicenter research comparing capsule~     endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer~     specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic~     accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and~     a high resolution colonoscope (with high definition). Both procedures will be perform in the~     same day with an adapted bowel preparation.~   "
181834|NCT01184768|"~     Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with~     lower hba1c values will be invited to an oral glucose tolerance test to see the predictive~     value of HBA1c in the diagnosis of type 2 diabetes.~   "
181835|NCT01184755|"~     Our aim is to conduct a randomized controlled trial (RCT) to test the efficacy of a guided~     breathing intervention on ambulatory blood pressure (ABP), both systolic and diastolic BP.~     There are 3 groups: 1) Intervention group instructed to use the RESPeRate device that guides~     the breath into the 6 breaths/minute range daily for 8 weeks. 2) Relaxation control condition~     (using a modified device to guide breathing at 13 breaths/minute rate); and 3) Usual Care~     (UC). After the initial 8 week trial, the main outcome, the intervention group will be~     randomly assigned to stop using the RESPeRate device or to continue using it for 8 more~     weeks.~   "
181836|NCT01184742|"~     The purpose of this study is to assess the relationship between physical fitness and~     wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers;~     and 3) self-reported avoidance of environmental features.~   "
181837|NCT01184729|"~     The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test~     (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap,~     wheelchair satisfaction, depression, and self-reported avoidance of environmental features.~   "
181838|NCT01184716|"~     Approximately 200 families corresponding to 800 persons are included in the study. The study~     investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in~     serum. Participants receive milk and bread twice a week. Half of the participants receive~     vitamin D fortified products and the other half similar non-fortified products. The study~     starts in September and runs for 6 months during winter, the period where it is not possible~     to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual~     fall in vitamin D status can be prevented by vitamin D fortified food.~   "
181839|NCT01184703|"~     The purpose of this study is to investigate if a low glycemic index diet in comparison with a~     medium/high glycemic index diet improves the metabolic control in patients with type 1~     diabetes.~   "
181840|NCT01184690|"~     Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout~     the entire small intestine. Although the originally described method requires two operators,~     the investigators have recently developed a method to perform DBE by a single operator. The~     investigators here assessed the clinical usefulness of this one-person method in comparison~     to the conventional two-person DBE.~   "
181841|NCT01184677|"~     The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would~     reduce the incidence of mucosal injury.~   "
181842|NCT01184664|"~     Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation~     treatments. Anecdotally smokers who are finding their quit attempt difficult have reported~     benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled~     double-blind study will examine whether combining NRT and varenicline provides better~     withdrawal and craving relief than varenicline alone. A total of 120 smokers would be~     randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All~     participants will receive standard NHS Stop Smoking Service support. The primary outcome~     would be ratings of craving and withdrawal discomfort 24 hours and one week after the target~     quit date.~   "
181843|NCT01184651|"~     The goal of this study is to help investigators to understand more about the development of~     characteristics related to being male or female (what is called gender development). The~     investigators will study girls with congenital adrenal hyperplasia (CAH) aged 10 to 13 to~     learn more about the girls' interests and activities, thoughts and feeling about being~     female, and family relationships. This will help investigators to understand the ways in~     which gender development is shaped by hormones and family relationships.~   "
181844|NCT01184638|"~     Cognitive disorders in patients underwent general anesthesia are discussed for decades, but~     whether there were precise relationship between general anesthesia and dysgnosia is yet to be~     guaranteed. Although controversial data reported from experimental studies in animals, the~     investigators still proposed that general anesthetics could impair the normally organized~     system of the central nervous system, which finally displayed a dysfunction of cognition~     after general anesthesia in a short- or long-term period. Therefore, different types of~     general anesthetics such as inhalational anesthetics and intravenous anesthetics, the~     investigators hypothesized, had a long-term influence on patients' cognitive ability.~   "
181845|NCT01184625|"~     The objectives of this study are to test if hypoxia in muscle tissue is an important factor~     contributing to clinical symptoms in chronic rheumatic muscle inflammation and to evaluate if~     a 12 week endurance exercise program will improve muscle tissue hypoxia and disability in~     patients with chronic rheumatic muscle inflammation.~   "
181857|NCT01184469|"~     The purpose of this study is to prospectively define a set of data suitable for developing~     models of pregnancy viability. Those models will be based on serum hCG concentration measured~     during the peri-implantation period in patients that received fresh embryo transfer and those~     that received transfer of frozen-thawed embryos, and to compare and contrast these models.~     This may reveal insights into differences between these types of IVF cycles.~   "
181846|NCT01184612|"~     Motivational Interviewing (MI) is a communication style demonstrated to decrease drug and~     alcohol use. A five session MI intervention (BSF) was implemented in the Swedish correctional~     system. The intervention was delivered by counsellors with workshop only MI training (BSF) or~     by counsellors with workshop MI training followed by peer group supervision based on audio~     taped feedback (BSF+).~      Aim was to examine whether BSF in prisons reduces drug and alcohol use more effectively than~     interviews conducted according to the usual planning interview routine (UPI).~   "
181847|NCT01184599|"~     The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin~     inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA~     nephropathy.~   "
181848|NCT01184586|"~     Dupuytren's disease is a progressive disease due to unknown causal agents or genetics.~      Dupuytren's disease contains nodules and cords in the fascia as the epicenter of disease~     progression. Nodules contain whorls of collagen bundles and are densely packed with~     contractile fibroblasts and myofibroblasts. These highly contractile cells are linked to the~     fascia matrix through transmembrane integrin receptors. The cytoplasmic tail domains of the~     alpha beta integrin receptors provide a structural link between extracellular matrix and the~     actomyosin cytoskeleton.~      Complications of surgical partial or total aponeurectomy in Dupuytren's disease are reported~     in up to 10% of cases . Often, surgical complications lead to compromised flexion limiting~     grasping function of the involved hand . A recent 20-year-review of the literature included~     41 clinical trials with complication rates reported from 3.6%to 39.1% . 16% major~     complications occurred with 3% digital nerve injuries, digital artery injuries in 2%,~     infections in 2%, and complex regional pain syndrome in 6%. Besides selective or total~     aponeurectomy, soft-tissue distraction has been suggested using either pneumatic devices or~     external fixateur .~      Non-invasive options include percutaneous fasciotomy or collagenase injection. The latter has~     been tested in a randomized-controlled trial published in the New England Journal of Medicine~     with 308 patients enrolled (NCT00528606) . Collagenase clostridium histolyticum significantly~     reduced contractures and improved the range of motion in joints affected by advanced~     Dupuytren's disease. In the long-term the cords at the level of the proximal interphalangeal~     joint appear to more recurrent than at the metacarpophalangeal joint after collagenase~     injection with an eight year follow-up .~      In early stage Dupuytren's contracture, radiotherapy has been suggested to limit disease~     progression. A cohort study of 135 patients with 208 hands involved received orthovoltage~     radiotherapy with a total dose of 30Gray separated by a six to eight week interval . After a~     follow-up of 13 years nodules and cords remained stable in 59%, improved in 10% and~     progressed in 31%.~      Beside Dupuytren's disease, there are a number of further less common fibromatosis, such as~     knuckle pads, M. Ledderhose , of the plantar fascia and peyronie disease at the penis. The~     latter has been treated by extracorporeal shockwave therapy. A randomized-controlled trial~     using 2000 focused shock waves reduced pain significantly and improved erectile function and~     quality of life . About half of the patients in one series of 44 patients had a significant~     reduction in angulation following shockwave therapy .~   "
181849|NCT01184573|"~     The goal of this study is to evaluate the feasibility of using a non-invasive,~     non-radioactive Pancreatic Breath Test (PBT) as a diagnostic tool to detect early stages of~     chronic pancreatitis (CP). If successful, this method could have important advantages over~     existing diagnostic tests for detecting early stage CP. This diagnostic breath test may have~     a clinical impact if it leads to early detection of CP and intervention to mitigate disease~     progression.~   "
181850|NCT01184560|"~     The purpose of this study, conducted academic Pilot research purposes, this is not clear as~     to permit. when orlistat to sibutramine merge if there are additional effects of BMI and~     group, which has an attribute that is greater for the combined effect is to analyze.~        -  Study phase: Investigator-initiated clinical study (Pilot study)~        -  Method of blinding: Double-blind~        -  Control: Placebo-controlled~        -  Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and~          Sibutramine combination group = 1 : 1)~        -  Studied disease: Obesity~        -  Study population: Subjects eligible for inclusion/exclusion criteria~        -  Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and~          post-dosing observation period (4 weeks)~   "
181851|NCT01184547|"~     The purpose of this proposal is to assess the efficacy of implementing a 12-week structured~     and supervised community-based exercise program (COMBEX) at hospital discharge. The~     investigators will assess the effect of exercise on mental health and physical function,~     along with its effects on the amelioration of the burn-induced catabolic response.~      The central hypothesis of this proposal is that exercise-induced physical and psychosocial~     benefits obtained during a supervised and structured COMBEX program in severely burned adults~     will improve physical function, and quality of life relative to Standard of Care (SOC).~   "
181852|NCT01184534|"~     Objective:~      To compare changes in patient anxiety levels between groups of patients who either were or~     were not exposed to an informative multimedia patient education tool, in order to determine~     how the addition of such a multimedia tool will affect this parameter. Specifically, the~     study will focus on subjective anxiety as measured on pre procedure and post procedure~     patient surveys as detailed under study components.~   "
181853|NCT01184521|"~     This is a study to evaluate the accuracy of the Masimo Rainbow SET Pulse CO-Oximeter in~     monitoring the hemoglobin levels of patients undergoing isovolemic hemodilution.~   "
181854|NCT01184508|"~     The primary objective of this study is to measure the change in frequency of migraine attacks~     per 28 days in migraine patients being treated orally with LY2300559 for 12 weeks.~   "
181855|NCT01184495|"~     A double-blind, randomized trial aimed to compare the efficacy of two formulations of~     erythropoietin in patients with chronic renal failure on hemodialysis~   "
181856|NCT01184482|"~     This trial is for patients with colon cancer, head and neck cancer and lung cancer that has~     not responded to standard therapy.~      Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or~     EGFR. It is thought that this receptor is turned on in some cancers, enabling cancer cells~     to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this~     receptor from the outside of cancer cells. It is thought that cancer cells can turn this~     signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks~     both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been~     found that combining drugs that target both EGFR and ErbB2 might work better in turning this~     signal back off. The purpose of this study is to determine the maximum dosages that patients~     can tolerate when these two medicines are given at the same time.~      In addition, in order to be on this trial, patients must agree to have a tumor biopsy before~     starting treatment on this study and 21 days after starting treatment. These biopsies are a~     required part of the study. Patients must also agree to have blood drawn for research testing~     to see whether genetic differences between patients explain different reactions to and side~     effects from, these medicines.~   "
181858|NCT01184456|"~     Improvement in the rate of bacterial translocation may lead to a decrease in a chronic~     inflammatory response thereby decreasing CD4 destruction and HIV proliferation.~      By the addition of probiotics we hope to show a reduction in LPS leading to a decrease in~     chronic inflammation and therefore an improvement in immune markers.~   "
181859|NCT01184443|"~     The purpose of this trial is to evaluate the safety and efficacy of the atypical~     antipsychotic, olanzapine, for the treatment of youth suffering from Anorexia Nervosa (AN).~      Adolescent males and females between the ages of 11 and 17 years who are being treated by a~     physician on the Eating Disorder team at the Children's Hospital of Eastern Ontario will be~     invited to join the study if they have been diagnosed with AN or Eating Disorder Not~     Otherwise Specified (EDNOS), and if they weigh less than or equal to 85% of their ideal body~     weight. Those who meet inclusion and not exclusion criteria, and consent to participating in~     the trial will be offered adjunctive treatment with olanzapine. Those who agree to take~     olanzapine will belong to the olanzapine group, and those who decline will belong to the~     comparison group. Olanzapine doses will be in keeping with the investigators current clinical~     practice, with flex doses ranging from 1.25 mg to 10.0 mg daily (the majority of patients are~     treated with 2.5 mg or 5.0 mg at bedtime); dose adjustments made based on individual need and~     tolerability. Participants will remain in the study for 12 weeks. Those who initially decline~     olanzapine treatment may change their minds and take olanzapine up until week 9 of the trial.~      It is hypothesized that those children and adolescents who choose to take olanzapine at entry~     into the trial will be more motivated to recover and more compliant with treatment. Compared~     to those who do not receive medication, it is expected that these adolescents will~     demonstrate reduced disordered eating attitudes and behaviours, as well as an increased rate~     of weight gain.~      Finally, it is predicted that the rates of discontinuation and the adverse effects of~     olanzapine will be minor given the relatively low dose (as compared to treatment for patients~     with schizophrenia), slow titration, and short-term use of olanzapine the investigators will~     be using.~      By comparing the well-being and outcome of patients in the two groups, the investigators hope~     to begin to answer the question of whether olanzapine does or does not lead to improved~     clinical outcome for patients with severe eating disorders such as AN or EDNOS, and the~     question of whether the benefits of using the medication outweigh the risks.~   "
181860|NCT01184430|"~     Cardiac surgery patients have a high risk to suffer from postoperative infections. Some~     studies have shown, that humoral and cellular factors are associated with perioperative~     immunodysfunction and can increase the risk of postoperative infections. Monocytes in the~     blood and, especially alveolar macrophages are important for an adequate host defence. In~     studies the investigators have shown that hemodynamic parameters have a significant influence~     on the probability to develop postoperative infections. The aim of the study is to~     investigate, whether cardiac surgery patients have an altered immune function after surgery~     that is predictive for the latter development of subsequent infections and whether they~     benefit from a goal-directed volume and hemodynamic therapy.~   "
181861|NCT01184417|"~     Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based~     alcohol withdrawal protocol will be associated with decreased need for ICU admission,~     continuous lorazepam infusion and will not be associated with increased adverse events.~   "
181862|NCT01184404|"~     Cardiac surgery relieves symptoms and increases life expectancy in cardiac patients, with and~     without congenital heart disease (CHD). However, cardiac surgery involves many risks of~     complications, such as bleeding, arrhythmias, and death.Right ventricular failure is another~     complication, contributing to poor clinical outcome. Right ventricular failure is a clinical~     syndrome, often difficult to treat, characterized by edema, elevated jugular venous pressure,~     oliguria, hypotension, and in severe cases shock, multi organ failure and death. Patients~     with CHD and patients with mitral valve lesions are suspected to be at increased risk for~     developing right ventricular failure post-operatively. In addition, other clinical factors~     contributing to right ventricular failure are mechanical pulmonary ventilation, pulmonary~     hypertension and cardiac surgery. Right ventricular failure during cardiac surgery is caused~     by the cardiopulmonary bypass by reperfusion with high partial pressures of oxygen, air~     embolism, and the release of cytokines. The endothelin-1 cytokine induces vasoconstriction of~     the pulmonary arterioles resulting in right ventricular afterload elevation. Treating~     patients with an endothelin-1 receptor antagonist might improve clinical outcome post~     operatively by decreasing right ventricular afterload~   "
181863|NCT01184391|"~     The objective of this study was to investigate the bioequivalence of Mylan's divalproex~     sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following~     a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.~   "
181864|NCT01184378|"~     The great majority of infants formula contain fats exclusively from vegetable oil.~     Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an~     infant formula closer to the nutritional composition of maternal milk.~   "
181865|NCT01184365|"~     Fatigue is a common complaint of persons with spinal cord injury (SCI) that negatively~     affects physical function, participation in daily activities, employment, and community~     involvement. No behavioural intervention for fatigue has been reported for SCI, though the~     benefits of such programs have been proven in persons with neurological conditions like~     multiple sclerosis and arthritis. Based on a study with people with SCI, an energy management~     program (EnMP-1) was developed. The focus of this study is to test EnMP-1. Adults with SCI~     living in the community and reporting fatigue as a problem will participate in the program.~      Hypothesis: Participants in the EnMP-1 group will show significantly lower fatigue impact~     scores and higher self-efficacy scores immediately after, 3 months, and 6 months~     post-intervention than EnMP-2 participants.~   "
181866|NCT01184352|"~     The objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon~     Catheter for crossing during the treatment of coronary artery disease.~   "
181867|NCT01184339|"~     Direct in-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and~     methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's~     bacteriophage-based diagnostic platform, two gold-standard reference methods, and two~     predicate devices with similar indications for use.~   "
181868|NCT01184326|"~     This research study is evaluating the combination of pazopanib and everolimus in patients~     that have a malignancy that is metastatic or unresectable and for which standard curative or~     palliative measures do not exist or are no longer effective, or metastatic or locally~     advanced unresectable kidney cancer. In this research study the investigators are testing the~     safety of the combination of pazopanib and everolimus as well as to find the appropriate dose~     to use for further studies.~   "
181869|NCT01184313|"~     The purpose of this prospective, randomized clinical trial is to understand and measure lung~     injuries caused by CPB in aortic valve surgery.~      Study questions:~        -  Is there any correlation between the release of pro-inflammatory biomarkers and lung~          injury degree?~        -  Is there any correlation between oxyhaemodynamic parameters and lung injury degree?~        -  Is there any correlation between oxyhaemodynamic parameters and the release of~          pro-inflammatory biomarkers?~        -  Are budesonide, erdostein and acetylcystein effective in the prevention of lung~          injuries?~   "
181870|NCT01184300|"~     The objective of the RAPID GENE study is to evaluate the feasibility, efficacy and safety of~     a pharmacogenomic approach to anti-platelet therapy following coronary artery stenting using~     a CYP2C19*2 point-of-care genetic test.~   "
181874|NCT01184248|"~     The purpose of this study is to investigate if sound stimulation could improve pure-tone~     hearing threshold.~      In the late 1990s, researchers discovered that acoustic stimuli slow progressive~     sensorineural hearing loss and exposure to a moderately augmented acoustic environment can~     delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic~     environment could improve age-related auditory changes. These ameliorative effects were shown~     in several types of mouse strains, as long as the acoustic environment was provided prior to~     the occurrence of severe hearing loss.~      In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing~     ability against damage by traumatic noise. In particular, a method called forward sound~     conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce~     noise-induced hearing impairment in a number of mammalian species, including humans.~      Interestingly, recent report has suggested that low-level sound conditioning also reduces~     free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces~     Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased~     cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and~     compound action potentials (CAPs) were measured.~      In addition to forward sound conditioning, backward sound conditioning (i.e., the use of~     acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing~     ability against acoustic trauma and to prevent the cortical map reorganization induced by~     traumatic noise.~      Based on the results of animal studies, the investigators conducted a human study in 2007 and~     observed that sound stimulation could improve hearing ability. On average, the pure-tone~     hearing threshold decreased by 8.91 dB after sound stimulation for 2 weeks. In that study,~     however, the investigators observed only the hearing threshold changes by sound stimulation.~      To verify the previous ameliorative effect of sound stimulation, the investigators included a~     control period in this study.~   "
181875|NCT01184235|"~     The study examines actigraphic, observational, psychometric and associated repeated~     measurements obtained prior to and during psychopharmacological treatment.~   "
181876|NCT01184222|"~     SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of~     great occipital nerve stimulation (GONS) associated with medication withdrawal in the~     treatment of medication overuse headache occurring in migraine patients.~   "
181877|NCT01184209|"~     Prospective study to evaluate incidence, causes and potential risk factors for adrenal crisis~     in patients with chronic adrenal insufficiency.~   "
181878|NCT01184196|"~     This study will enroll patients who will be receiving primary total knee replacements.~     Subjects will be randomized into two groups: Betadine surgical scrub preparation and~     ChloraPrep preparation prior to total knee replacements.~      Study hypothesis: When used as a surgical scrub preparation prior to primary total knee~     arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior~     to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.~   "
181879|NCT01184183|"~     Carotid Endarterectomy (CEA), surgical removal of the blockage in the neck artery, is the~     accepted management of choice for significant blockage of the carotid artery. Previous~     studies showed improved perioperative outcomes and prevention of recurrent blockage by the~     use of the patch to close the surgical incision in the artery. The ideal patch reduces~     bleeding and prevents recurrent blockage.This is looking at long-term results toward~     improvement with the use Accuseal patch than Bovine Patch.~   "
181880|NCT01184170|"~     The purpose of this study is to learn more about why some obese persons are resistant to~     developing obesity-related metabolic diseases (such as diabetes and cardiovascular disease),~     while others are prone to developing these conditions. We will do this by studying obese~     persons before and after a 5% body weight gain.~      Subjects will be asked to increase their current diet for a period of 8-12 weeks in order to~     increase their current body weight by 5%. Each will then be asked to maintain this weight~     increase for 3 weeks. We will monitor subjects throughout this time period with weekly~     medical evaluations. At the completion of the study, we will provide each subject with a~     6-month weight loss program.~   "
181881|NCT01184157|"~     This study randomizes women using long-acting reversible methods of contraception to~     home-based STD screening through the mail compared to screening available in a clinical~     setting. We hypothesize that women randomized to home-based screening will be more likely to~     complete screening.~   "
181882|NCT01184144|"~     The purpose of this study is to compare the effect of pioglitazone versus no drug on soluble~     profinflammatory markers in peritoneal fluid of women with endometriosis.~   "
181883|NCT01184131|"~     The research proposed in this collaborative application Implementation and Evaluation of~     Formal Training for Mentors of K-Series Mentored Career Development Awards will uniquely~     study mentor training in the biomedical academic community. The randomized controlled trial~     will be conducted at 15 Clinical and Translational Science Award sites over a 21-month period~     with six months for baseline data collection, nine months for the intervention, three months~     for follow-up, and three months for analysis. The multi-site trial will be conducted to~     determine whether the resultant skills-focused, case-based, mentor training program can~     improve the mentoring skills of K series mentors.~   "
181884|NCT01184118|"~     This study is being conducted to find out if the use of inhaled corticosteroids has an affect~     on upper airway (UAW) collapsibility and sleep apnea risk. An inhaled corticosteroid is a~     common asthma controller medication like Flovent. Sleep apnea or sleep deprived breathing~     (SDB) is when someone stops breathing for a short period of time during sleep. For some~     reason, people with asthma have more sleep apnea and upper airway (UAW) collapsibility~     (weakness) than the general population. There are many possible reasons for this and one~     might be related to the use of inhaled corticosteroids.~      The overall hypothesis of this study is to determine whether inhaled fluticasone propionate~     (FP) increases UAW collapsibility and to assess tongue (genioglossus muscle) dysfunction as a~     potential underlying mechanism.~   "
181885|NCT01184105|"~     A phase I, single-center, double-blind, randomized, placebo-controlled, safety and~     pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and~     prilocaine and the metabolites, 2,6-dimethylaniline (2,6-DMA) and o-toluidine, in female~     healthy volunteer subjects following daily application of 60 mg PSD502 or placebo to the~     vagina and cervix for seven days~   "
181886|NCT01184092|"~     In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on~     three separate occasions using one of three different tablet formulations (tablet versions)~     each time. The amount of tasocitinib (CP-690,550) available in the blood following~     administration of each tablet formulation will be measured and compared. The overall aim of~     the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into~     the blood following administration of the same dose of each different tablet formulation.~   "
181902|NCT01183871|"~     The investigators hypothesize that the lung resection would be associated with lower jugular~     bulb oxygen saturation in patients with severe pulmonary dysfunction than in patients with~     healthy lung functions.~   "
188620|NCT01095588|"~     This study is designed to look into the effect of avanafil on blood levels of warfarin and to~     investigate its effect on prothrombin time/international normalized ratio (INR) in healthy~     men.~   "
181887|NCT01184079|"~     The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine~     among males 18-24 years old, comparing an on-time administration of the third dose with~     delayed administration of the third dose. All participants would receive the first and second~     doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3~     at 12 months.~      Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the~     usual timing control group (C):~      H0: δ ≤ −δ0 versus H1: δ > −δ0 where δ = log (GMTT )− log (GMTC) and δ0 is the pre-specified~     non-inferiority margin~   "
181888|NCT01184066|"~     The 5-year survival after a first diagnosis of breast cancer is 13% lower in black than in~     white American women, an alarming disparity that cannot be explained by stage of disease at~     presentation. Nonadherence to breast cancer treatment and treatment delays from diagnosis to~     initiation of treatment may be among the reasons for worse breast cancer outcomes in black~     women. This recognition is critical because it suggests that breast cancer survival disparity~     can be decreased through clinical interventions that increase adherence to chemotherapy. The~     ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime, intensive~     psycho-educational intervention using a race-matched breast cancer survivor interventionist~     to: address Attitudes, including perceptions and stressors, that may impact adherence to~     clinical visits and treatment; encourage and model patient Communication with health care~     providers regarding physical and emotional needs, with attention to race-discordant~     situations; and provide tailored, understandable information about Treatment and its~     rationale. The Support component is threaded throughout the intervention via the presence of~     a race-matched breast cancer survivor and supportive video messages from the black community.~     This study is a randomized controlled trial that will test the efficacy of the ACTS~     Intervention vs. Usual Care on the primary outcomes of adherence to recommended breast cancer~     chemotherapy.~   "
181889|NCT01184053|"~     The primary purpose of this study is to see whether women who have already received~     chemotherapy for their endometrial cancer, or who have disease that has spread outside of the~     uterus, will respond to the drug arsenic trioxide (Trisenox®) as judged by shrinkage of their~     tumor.~   "
181890|NCT01184040|"~     Contingency Management (CM) is highly effective in promoting recovery from substance use~     disorders, but benefits tend to attenuate over time when CM is discontinued. Identifying~     modifications of CM delivery that can extend its benefits is an important goal. The goal of~     this study is to evaluate the use of reinforcements to increase physical activity,~     specifically walking. The study provides a standard CM intervention to promote walking for~     three weeks. After three weeks, a progressively increasing variable interval schedule of~     reinforcement will be evaluated for increasing the durability of effects of the initial CM~     intervention. We hypothesize that Variable Interval Prize Contingency Management will result~     in greater adherence to a walking goal of 10,000 steps per day at Week 15 and Week 24~     compared to the Control Condition.~   "
181891|NCT01184027|"~     Weight loss resulting from poor food intake is common in head and neck cancer patients.~     Currently, feeding tubes are placed before starting treatment to provide nutrition and~     prevent weight loss. However, studies have not always shown that feeding tubes prevent weight~     loss. Also, limiting food intake by mouth may lead to swallowing problems. The aim of this~     study is to compare the effect of diet and swallowing therapy with feeding tube placement. In~     this study, your weight, food intake, swallowing ability, and side-effects of treatment will~     be monitored before, during, and 3 and 6 months after treatment to see if there is any~     difference between the therapy groups. The investigators hope that with the addition of diet~     and swallowing therapy during treatment that we can improve food intake and swallowing~     ability while still maintaining weight.~   "
181892|NCT01184014|"~     The objective of this study is to determine the best insulin regimen for hospitalized~     patients who receive high doses of steroids who have high blood glucose.~   "
181893|NCT01184001|"~     In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy~     subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550)~     tablet will be administered in a fasting condition; On the other occasion the tasocitinib~     (CP-690,550) tablet will be administered in a fed condition following a standard breakfast~     meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times~     over 24 hours following each dosing occasion and compared to evaluate for any differences.~   "
181894|NCT01183975|"~     Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample~     of centers representative of this activity in France.~      Verification by means of a screening log (exhaustive list of all bariatric procedures~     performed by participating surgeons between the beginning and end of the cohort inclusion~     period) requested from all centers.~      No comparator group. No randomization or blinding techniques~   "
181895|NCT01183962|"~     The purpose of this study is to evaluate the effect of Vitamin D supplementation on~     cardiovascular disease and certain cells (T-regulatory cells) in the body that play a role in~     plaque formation in arteries. This study will determine the levels of Vitamin D and~     T-regulatory cells in subjects with coronary artery disease and if Vitamin D supplementation~     will affect future events such as heart attach and stroke.~   "
181896|NCT01183949|"~     The purpose of this study is to determine whether AT7519M alone or AT7519M plus bortezomib~     are effective treatments in patients with previously treated multiple myeloma.~   "
181897|NCT01183936|"~     Objectives: The purpose of this study was to assess the effects of an excision margin of 2 cm~     versus 4 cm for patients with primary cutaneous malignant melanoma (CMM).~      Study hypothesis: The hypothesis is that there is no difference between the two treatment~     arms measured as overall survival and recurrence free survival.~   "
181898|NCT01183923|"~     Sulforaphane (SFN) is a naturally occurring isothiocyanate that is a potent inducer of Phase~     II enzymes which play a critical role in preventing oxidative stress (via activation of~     Nrf2). Broccoli sprouts (BS) contain the richest source of SFN.~      The main objectives of this study are to test the effect of broccoli sprouts (BS) on~     biomarkers of oxidative stress (OS), inflammation, basophil activation, and clinical outcomes~     in mouse allergen-induced asthma by (1) determining if BS improves lung function and airways~     symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse~     allergen challenge (EMAC), (2) examining the effect of BS on OS, inflammation, and basophil~     activation, and (3) examining the effect of BS on changes in OS, inflammation, and basophil~     activation after EMAC.~   "
181903|NCT01183858|"~     This prospective, double-blind, randomized study will evaluate the safety and efficacy of two~     dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control~     rates and overall survival in patients with advanced or metastatic non-small cell lung cancer~     (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current~     smokers and not intending to stop smoking during the study. Patients will be randomized to~     receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will~     continue until disease progression.~   "
181904|NCT01183845|"~     The Crohn's Disease Endoscopic Index of Severity is a validated index to assess the severity~     of ileocolonic lesions. Depth of ulcerations are evaluated in each segment of ileocolon and~     the surface of lesions and ulcerations are reported on a 10-cm analogic scale. The Crohn's~     Disease Endoscopic Index of Severity is the main score used in controlled trials to assess~     the endoscopic severity of lesions in Crohn's Disease.~      The investigators aim to conduct a prospective pilot study primarily to evaluate the~     applicability of the Crohn's Disease Endoscopic Index of Severity to data obtained by the~     colonic capsule endoscopy procedure, provided that conventional ileo-colonoscopy and capsule~     endoscopy lead to comparable overall severity evaluations.~      Secondary objectives are to assess reproducibility of the reading of data obtained by CCE and~     to compare these data with those obtained by conventional ileocolonoscopy. If overall~     severity evaluations derived from the two examinations are not comparable, the secondary~     objectives will be used in an attempt to understand the reasons of this discrepancy.~   "
181905|NCT01183832|"~     This study is a description of the radiation effects on the healthy tissues in patients~     receiving Anastrozole, sequential or in association with radiotherapy.~   "
181906|NCT01183819|"~     The purpose of this study is to test the hypothesis that aerobic exercise and a~     computer-based cognitive intervention leads to improved cognitive function accompanied by~     increases in gray matter density and changes in functional magnetic resonance imaging (fMRI)~     patterns of task-related activation.~   "
181907|NCT01183806|"~     The purpose of this study is to determine whether a exercise program when combined with~     rivastigmine (Exelon patch) drug treatment compared with rivastigmine drug treatment alone~     would improve quality of life, ability to perform activities of daily living (ADL) and~     cognition in patients with Alzheimer's disease.~      Hypothesis:~      Ho: Rivastigmine drug treatment combined with exercise is not superior to rivastigmine drug~     treatment to improve quality of life of Alzheimer's disease patients.~      H1: Rivastigmine drug treatment combined with exercise is superior to rivastigmine drug~     treatment to improve quality of life of Alzheimer's disease patients, with an expectative of~     15% of improvement in the quality of life scale measurement~   "
181908|NCT01183793|"~     It is essential to know intestinal length and anastomotic type in post-operative short bowel~     syndrome patients. These parameters can help predict long-term intestinal failure with~     long-term parenteral nutrition usually needed for smallest lengths. Sometimes these~     parameters are unfortunately missing for lack of intraoperative measurement. Thus, it is~     necessary to develop non-invasive and reproducible techniques to assess small bowel length.~     This is the reason why the investigators will evaluate magnetic resonance (MR)-enterography~     and barium follow-through in this indication. There are at this time only two small studies~     evaluating barium follow-through for intestinal length measurement, and none evaluating~     MR-enterography. However, a major advantage of the latter is the lack of radiation exposure~     and possibility to perform 3D.~      This will be an open labelled single center crossover study. Short bowel syndrome patients of~     the investigators center will be included after consent. The sequence of exams (MR~     enterography followed by barium follow-through or vice-versa) will be randomly assigned.~     Peroperative short bowel length measurement will be available for all patients. There will be~     one month between the two exams.~      The main objective of this study is to assess the performance of MR-enterography in short~     bowel measurement in short bowel syndrome patients, the gold standard being peroperative~     length. Secondary objectives are to assess the performance of barium follow-through in short~     bowel measurement in these patients, and to show that barium follow-through does not perform~     better than MR-enterography. For that purpose the investigators will include 50 patients over~     2 years.~   "
181909|NCT01183780|"~     The purpose of this study is to compare overall survival in participants with metastatic~     colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.~   "
181910|NCT01183767|"~     The aim of this multicentre, prospective, double blind, placebo controlled, randomized pilot~     study is to investigate safety and tolerance of Epigallocatechin-Gallate (EGCG, the major~     polyphenol in green tea) in patients with muscular dystrophy of the Duchenne type.~      In a second step the investigators want to investigate the effect of EGCG on the course of~     the Duchenne condition.~   "
181911|NCT01183754|"~     1. To evaluate the role of VerifyNow test as prognostic marker in routine clinical practice~          using drug-eluting stents.~        2. To determine the add-on-effect of VerifyNow test beyond on conventional risk factors~          (clinical, lesions, or procedural factors).~        3. To compare the prognostic utility of VerifyNow test with several biomarkers.~   "
181912|NCT01183741|"~     The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational~     device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood~     pressure (BP) in adult subjects.~   "
181913|NCT01183728|"~     In this prospective study we aim to evaluate the feasibility and safety of the implantation~     of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The~     working hypothesis proposes that MSV antiinflammatory effect will help healing of articular~     cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging~     procedures. The study of quantitative changes in structure and composition of cartilage~     determined by MRI T2-mapping (Cartigram ) will be performed at 6, 12 and 24 months. Pain and~     disability will be assessed by visual analogue scale (VAS), WOMAC, Lequesne Index and~     evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3, 6,12~     and 24 months.~   "
181914|NCT01183715|"~     The primary purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.~   "
181915|NCT01183702|"~     The research will utilize LASIK and non-LASIK populations to analyze the biomechanical~     differences between these corneas.~   "
181916|NCT01183689|"~     The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test~     whether behavioral interventions based on self-regulation can prevent weight gain in young~     adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation~     interventions for weight gain prevention will be compared in this trial; one intervention~     will focus on making small, consistent, changes in eating and exercise behavior to prevent~     weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger~     changes in eating and exercise that occur periodically, with a goal of producing weight loss~     and thereby providing a buffer against anticipated weight gains. The primary aim of the trial~     is to test whether the magnitude of weight gain from baseline across an average three-year~     follow-up differs across the three groups, with the hypotheses that weight gain will be~     greater in the Control group than in either intervention and greater in the Small Changes~     than Large Changes group.~      SNAP-E (Extension) will determine whether the effects of the intervention can be maintained~     over an additional 3 years (i.e. through a total of 6 years).~   "
181917|NCT01183676|"~     The objective of this study was to investigate the bioequivalence of Mylan's divalproex~     sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following~     a single, oral 500 mg (1 x 500 mg) dose administration under fed conditions.~   "
181918|NCT01183663|"~     The goal of this clinical research study is to find the highest tolerable doses of the~     combinations of lenalidomide and other drugs that can be given to patients with advanced~     cancer. The safety of the drug combinations will also be studied.~   "
181919|NCT01183650|"~     The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and~     non-Japanese men with Benign Prostatic Hyperplasia (BPH).~      The safety of tadalafil will also be studied.~   "
181920|NCT01183637|"~     The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to promote~     repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage meeting~     eligibility criteria will be randomly assigned to receive treatment with the Cartilage Repair~     Device or a standard surgical technique called microfracture. The purpose of the study is to~     evaluate the initial safety and effectiveness of the Cartilage Repair Device compared to~     microfracture.~   "
181921|NCT01183624|"~     An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain~     of the right or left knee.~   "
181922|NCT01183611|"~     The primary safety objective of this study is to assess the safety of 10 mcg recombinant~     hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is~     to assess the antibody response following 3 doses immunization of the 10 mcg experimental~     dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates.~     This is a randomized, double-blinded, Phase III study. This study is designed to investigate~     the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine~     (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg,~     positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg and~     HBeAb and HBcAb.~        -  Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and~          HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects~          will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control~          vaccine respectively.~        -  Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but~          negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240~          subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10~          mcg control vaccine respectively.~        -  Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and~          HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the~          10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the~          other 300 subjects will receive 5mcg control vaccine.~      The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each~     immunization, safety will be measured by assessment of adverse events through 30 days~     following each vaccination, serious adverse events and new-onset chronic medical conditions~     through 6 months post the final vaccination (Day 180 after last vaccination). For the~     immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the~     day 0, 210 and 360 after born.~   "
181923|NCT01183598|"~     This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a~     maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit~     from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or~     significant adverse events. Patients will receive their most effective maintenance dose until~     disease progression or significant toxicity occurs.~   "
181924|NCT01183585|"~     This single centre, open-label study will investigate the effect of RO4917838 on the~     pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers.~     Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of~     Rosuvastatin.~   "
181925|NCT01183572|"~     The purpose of this study is to determine whether daily oral supplements of multivitamins~     (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant~     women results in lower prevalence of anemia in preparation for pregnancy when compared to~     daily iron and folic acid supplements or folic acid alone.~   "
181926|NCT01183559|"~     The purpose of the study is to determine the most tolerable and safe dose of ZD6474 (Zactima)~     when given with standard chemotherapy, radiation therapy and surgery in patients with cancer~     of the esophagus~   "
181927|NCT01183546|"~     The purpose of this research study is to further develop and refine the Transfer Assessment~     Instrument (TAI). The TAI is a clinical tool to be used by therapists to evaluate transfer~     techniques and performance.~   "
181928|NCT01183533|"~     The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV~     t-PA) in ischemic stroke patients who present to the emergency department (ED) after~     awakening with the symptoms of suspected ischemic stroke.~   "
181929|NCT01183520|"~     The overall goal of this project is to identify an appropriate level of high omega-3 fish~     (salmon) consumption that will promote optimal omega 3 nutritional status without increasing~     the level of lipid oxidation in the body.~   "
181930|NCT01183507|"~     The purpose of this research study is to evaluate the effect of two different exercise~     programs on physical function in men and women 60 years of age and older.~   "
181931|NCT01183494|"~     This study is being done to determine the maximum dose of a certain chemotherapy drug~     (irinotecan) that can be tolerated as part of a combination of drugs. There is a combination~     of chemotherapy drugs typically used to treat cancer of the colon and rectum: 5-Flurouracil~     (5-FU), leucovorin, and irinotecan; the combination is known as FOLFIRI. At the present time,~     the Food and Drug Administration (FDA) has approved this drug combination for the treatment~     of cancers of the colon and rectum. The FDA has also approved the use of a drug called~     bevacizumab (or Avastin) in combination with FOLFIRI, and this is considered one of the~     standards of care for all patients with colon and rectal cancer which has spread.~      The best dose of irinotecan to use in the combination of FOLFIRI and bevacizumab is not~     known. Earlier studies have shown that higher doses of irinotecan can be used safely as part~     of the FOLFIRI combination, but it is unclear whether these same doses will be safe when~     bevacizumab is added to this combination.~   "
181932|NCT01183481|"~     The primary objective of this pilot study is to examine the efficacy of Aprepitant given in~     combination with Granisetron for the prevention of delayed-phase RINV in 84 patients~     receiving a single 8Gy of moderately emetogenic palliative RT in the RRRP at Sunnybrook~     Odette Cancer Centre for painful bony metastases from any primary solid tumor. Patients will~     be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least~     one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings~     on Days 1 and 2 following the radiation treatment.. Secondary objectives include determining~     the complete RINV prophylaxis rate (acute and delayed phases), the partial emesis control~     rate, the safety of the combined regime, QOL issues, the time to the first emetic event and~     the time to the first use of rescue medication .~   "
181933|NCT01183468|"~     The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an~     anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's~     normal ability to fight infection and respond to injuries) that affects the cells thought to~     be involved in the development of type 1 diabetes mellitus (T1DM, T1D).~      All subjects enrolled in this study have new-onset T1DM (diagnosis of T1DM within 100 days of~     Visit 0; T1DM diagnosis fulfilling American Diabetes Association standard T1DM criteria). The~     focus of Part I of this trial (NCT01183468) is pharmacokinetics (PK), pharmacodynamics (PD)~     and safety. Upon completion of Part I, including a satisfactory safety review, enrollment in~     Part II (NCT01183455, Phase II Clinical Trial) will begin.~   "
181934|NCT01183455|"~     Aralast NP (alpha-1 antitrypsin, AAT), an alpha-1 proteinase inhibitor (human), was the drug~     to be tested in this clinical trial. Aralast NP is an anti-inflammatory drug that affects the~     cells that are thought to be involved in the development of type 1 diabetes mellitus (T1DM,~     T1D). This study, known as RETAIN, was planned as a two-part trial to investigate the effect~     of Aralast NP on preserving beta cell function and to determine if the intervention would~     slow the progression of type 1 diabetes.~      Part I of this trial (NCT 01183468) was an open-label, safety and dose level study consisting~     of two groups. After completion of Part I, including a satisfactory safety review, enrollment~     in Part II was to begin. Part II was designed as a two-arm, double-blind, placebo-controlled~     clinical trial, and participants were to be randomly assigned to either the Aralast NP~     treatment or placebo group.~   "
181935|NCT01183442|"~     The main aim of the investigation is to clarify, whether vitamin D supplementation in~     coronary artery disease patients with vitamin D deficiency and postchallenge hyperglycemia~     has an impact on endothelial dysfunction and parameters of insulin sensitivity and beta-cell~     function.~   "
181936|NCT01183429|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     3F8 and GM-CSF has on the patient and the cancer.~      Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of~     one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has~     been used safely in many patients, and it has killed cancer cells in some patients. One way~     it can kill cancer cells is by causing the patient's own white blood cells to attack the~     cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of~     granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.~   "
181937|NCT01183416|"~     The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than~     standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what~     effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the~     antibody works against a very small amount of neuroblastoma (minimal residual disease) that~     is left in the bone marrow.~   "
181938|NCT01183403|"~     The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has~     not been clearly demonstrated. The results reported by some teams suggest no beneficial~     effect or even an increased risk of bowel obstruction in the case of stricture, while other~     publications indicate a favourable action of anti-TNF in this setting. The efficacy of~     anti-TNF in patients with intestinal stricture related to Crohn's disease could depend on the~     lesions responsible for the stricture, as anti-TNF agents are probably effective in~     inflammatory forms and useless or even potentially harmful in fibrotic forms. In practice,~     the decision is currently empirical and a trial of anti-TNF therapy is often proposed.~      In view of the high incidence of intestinal strictures in CD and the need for a treatment as~     effective as anti-TNF in this setting, it is important to more clearly define the indications~     of these treatments guided by the information provided by modern imaging.~      The aim of this prospective study is to determine whether certain signs detected by MR~     enterography and contrast-enhanced ultrasonography can help to predict failure of anti-TNF~     therapy in patients with CD presenting a symptomatic stricture of the small bowel and~     scheduled to receive this treatment.~   "
181939|NCT01183390|"~     The objective of this study is to evaluate the comparative bioavailability between~     Anastrozole 1 mg Tablets (Teva Pharmaceuticals, USA) and Arimidex® 1 mg Tablets (AstraZeneca~     Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fed conditions.~   "
181940|NCT01183377|"~     Women's evermore presence in professional and athletic sports has revealed sound evidence on~     the existence of female athlete triad among the world's elite female athletes. This triad~     consists of eating disorders, amenorrhea and osteoporosis. It has been stated that all female~     athletes are potentially at risk, but it is not clear to what extent those exercising at~     different levels are at risk of this syndrome/triad. Since the manifestation of this triad is~     often denied, or under-reported, appropriate screening methods are required to identify the~     symptoms. There is still no clear-cut information available on the incidence of this triad in~     Iran. And there are religious and cultural differences between Iran's elite female athletes~     and those in other countries. Therefore, in order to meet Iranian female athletes' needs, the~     investigators decided to determine the frequency of the female athlete triad in Iran.~   "
181941|NCT01183364|"~     This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of~     STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor~     malignancies. The safety and tolerability of the treatment will also be evaluated.~   "
181995|NCT01182636|"~     The objective of this study was to evaluate the efficacy and safety of the test formulation~     of adapalene gel 0.1% (PLIVA Research & Development Ltd.) as compared to the already marketed~     formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with~     acne vulgaris.~   "
181942|NCT01183351|"~     The increasing prevalence of dementia is a major challenge to the health authorities in most~     countries. Nearly all the persons suffering from dementia experience behavioural and~     psychological symptoms (BPSD). The prevalence of BPSD is particularly high in nursing homes.~     BPSD are often treated with psychotropic drugs even though the evidence for effect is minimal~     and the risk of serious adverse events is considerable. All the major treatment~     recommendations advise that non-pharmacological measures should be applied first when~     treating BPSD even though the evidence for such treatment is limited. The investigators will~     conduct a pilot study of a non-pharmacological treatment for BPSD. The method has been~     developed in Norway and has already been implemented in a number of nursing homes in the~     county of Nordland.~   "
181943|NCT01183338|"~     The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational~     device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human~     subjects.~   "
181944|NCT01183325|"~     For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or~     the use of mesh continues.~      About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh~     with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of~     using this patch, recent experience showed several drawbacks both in design and efficacy (3).~      With the recent development of the Proceed Ventral Patch (PVP), new elements have been~     introduced to overcome some of these issues.~      The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the~     intra-abdominal position in the treatment of small ventral hernias.~   "
181945|NCT01183312|"~     The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness~     and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is~     caused by a problem with the quality of sleep occurring at night, for instance when nighttime~     sleep is disrupted by frequent breathing pauses. In other cases, however, hypersomnia occurs~     even when nighttime sleep is of good quality. These cases of hypersomnia are presumed to be a~     symptom of brain dysfunction, and so are referred to as hypersomnias of central (i.e., brain)~     origin, or primary hypersomnias.~      The causes of most of these primary hypersomnias are not known. However, our group has~     recently identified a problem with the major brain chemical responsible for sedation, known~     as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance~     that causes the GABA receptor to be hyperactive. In essence, it is as though these patients~     are chronically medicated with Valium (or Xanax or alcohol, all substances that act through~     the GABA system), even though they do not take these medications.~      Current treatment of central hypersomnias is limited. For the fraction of cases with~     narcolepsy, there are FDA-approved, available treatments. However, for the remainder of~     patients, there are no treatments approved by the FDA. They are usually treated with~     medications approved for narcolepsy, but sleep experts agree that these medications are often~     not effective for this group of patients.~      Based on our understanding of the GABA abnormality in these patients, we evaluated whether~     flumazenil (an medication approved by the FDA for the treatment of overdose of GABA~     medications or the reversal of GABA-based anesthesia) would reverse the GABA abnormality in~     our patients. In a test tube model of this disease, flumazenil does in fact return the~     function of the GABA system to normal. The investigators have treated a few patients with~     flumazenil and most have felt that their hypersomnia symptoms improved with this treatment.~      To determine whether flumazenil is truly beneficial for primary hypersomnia, this study will~     compare flumazenil to an inactive pill (the placebo). All subjects will receive both~     flumazenil and the placebo at different times, and their reaction times and symptoms will be~     compared on these two treatments to determine if one is superior. Currently, flumazenil can~     only be given through an injection into a vein (i.e., intravenously). This study will~     evaluate this intravenous dosing as well as a new form of flumazenil, which is taken as a~     lozenge to be dissolved under the tongue. If this study shows that flumazenil is more~     effective than placebo in the treatment of hypersomnia, it will identify a potential new~     therapy for this difficult-to-treat disorder.~   "
181946|NCT01183299|"~     The Salty Life 7 study aimed to examine the effect of a high salt (sodium chloride, NaCl)~     intake on different forms of sodium retention, acid-base balance and bone metabolism and~     other influenced physiological systems. Because of the fact that astronauts are a vulnerable~     group in this context, they were of special interest. Astronauts have a high salt intake,~     probably because of a reduced sense of taste, as well as an increased bone resorption~     resulting from the lowered mechanical load in space. In which forms sodium could be retained~     even without fluid retention (osmotically inactive)- contrary to the argumentation of~     physiological text books - and if the acid-base balance is connected to sodium chloride~     induced bone loss is examined in a stationary bed rest study with 8 healthy, young, male test~     subjects. The study consisting of 2 x 21 days is carried out at the German Aerospace Center~     (DLR). After an adaptation period of 4 days, test subjects are immobilised in 6° head-down~     tilt bed rest (simulation model for some physiological changes in space) for 14 days during~     which they received a high (7.7 mmol NaCl/kgBW/d) and a low salt (0.7 mmol NaCl/kgBW/d)~     intake in cross-over design. The form of sodium retention is investigated by the calculation~     of daily metabolic sodium-, water- and potassium balances and by changes in body weight. The~     measurements of bone formation (bAP, PINP, Osteocalcin) markers as well as bone resorption~     markers (CTX, NTX) supply insight into the influences of a high salt intake on bone~     metabolism. Blood gas analysis and ph values of 24-h urine are used to gather information~     about accompanying changes in the acid-base balance. Further physiological systems like~     energy metabolism and circulation system are also under investigation.~   "
181947|NCT01183286|"~     Adolescents with cystic fibrosis are particularly vulnerable to poor adherence, which~     negatively impacts their health status, quality of life and long term survival. CFFONE: A~     Cell Phone Support Program for Adolescents with Cystic Fibrosis, will make use of~     cutting-edge technology- a broadband capable, cellular telephone keyed into a~     highly-interactive informational web site. This web site will provide engaging online~     learning activities and resources specific to adolescents with cystic fibrosis. We believe~     the information and activities contained in CFFONE will improve adolescents knowledge,~     attitudes, and practices around cystic fibrosis and that adolescents exposed to the CFFONE~     program will demonstrate an increase in adherence to their treatment regimens and related~     improvements in their health status and quality of life.~   "
181960|NCT01183104|"~     The purpose of this study is to compare the efficacy and the safety of sitagliptin and~     glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change~     from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as~     safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy~     as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride~     in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In~     addition, comparison of efficacy is extended to 104 W.~   "
181961|NCT01183091|"~     The atrial fibrillation is the most frequent confusions of the heart rhythm: his preValencia~     increases with the age, and the investigators consider that beyond 65 years, 5 % of the~     population is affected by this arrhythmia. It entails a greater risk of morbidity~     (thromboembolic accident and cardiac insufficiency) and of cardiovascular mortality~     (mortality increased by a factor 1,7 - 2) independents of the causal pathology or the~     associated risk factors. For all these reasons, it raises a real problem of public health.~   "
181948|NCT01183273|"~     Background Laparoscopy is the preferred surgical approach for a number of different diseases~     as it allows for diagnosis and treatment in the setting of a safe and feasible method~     offering enhanced cosmesis. The natural evolution of laparoscopy is micro-laparoscopy which~     utilizes smaller instruments and optics. Technological advancements have enabled~     miniaturization of the surgical equipment without compromising diagnostic or operative~     capabilities.~      Dr. Keith Zuccala is currently performing micro-laparoscopic gastric bypass with an identical~     safety profile as traditional laparoscopy (NSQIP data comparison between Dr. Laura Choi and~     Dr. Keith Zuccala). The current trend in laparoscopy is to minimize incisions and their size~     to decrease trauma to the abdominal wall.~      Study Design Both methods have never been compared in a prospective randomized trial to~     address the following questions.~        1. Is there a difference in outcome?~        2. Is there a decrease in postoperative pain?~        3. Does it decrease time off from work?~        4. Does micro-laparoscopy increase OR time?~        5. What is the effect on cost of micro-laparoscopy? Patients will be randomized to one or~          the other method, disclosing that to the investigators best knowledge both methods are~          equally safe and that Dr. Zuccala has performed several hundred cases using both~          methods.~      Patient Population Projected sample size would be 50 patients in each group. Accrual should~     be feasible over the course of 9-12 months.~      Data collection (patients will be followed for a total of 30 days for the purpose of this~     study)~        1. NSQIP data to assess outcome~        2. Postoperative usage of pain medication while in the hospital~        3. Time off from work~        4. OR time~        5. Direct cost of procedure as it relates to material used~   "
181949|NCT01183260|"~     In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology,~     Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was~     developed to address the limitations of other implant materials, with the potential to~     improve implant fixation.~      Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft~     incorporation, believed to be restricted by the low porosity of other commonly used implants~     (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum~     provides more normal physiological loading conditions which theoretically reduce stress~     shielding and resultant bone loss surrounding the implant. These properties are much desired~     advantages for implants used in cementless THA.~      Various porous tantalum implants have shown favorable clinical results. Unger et al. reported~     excellent bone graft incorporation of the acetabular component based on serial radiograph~     data at a minimum 1-year follow-up.~      Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting~     periprosthetic bone mass changes around the femoral and acetabular THA components.~      The primary objective of this study is to quantify and compare periprosthetic bone mineral~     density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed~     acetabular components, measured using DEXA scanning techniques. Additionally, this study will~     analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.~   "
181950|NCT01183247|"~     An open, single center, randomised study to investigate three different immunosuppressive~     regimens for de novo renal transplant recipients:~        1. st sirolimus / EC-MPS / tacrolimus regimen~           - After 3 months a protocol biopsy is performed. If no rejection is detected the~          calcineurin inhibitor (tacrolimus) is withdrawn.~        2. nd everolimus / EC-MPS / tacrolimus regimen~           - After 3 months a protocol biopsy is performed. If no rejection is detected the~          calcineurin inhibitor (tacrolimus) is withdrawn.~        3. rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is~          performed. If no rejection is detected prednisone is withdrawn.~   "
181951|NCT01183234|"~     The purpose of this study is to assess bioequivalence of 2 capsule strengths.~   "
181952|NCT01183221|"~     This study examines the effects of oxytocin on complex social cognition in adults with autism~     spectrum disorders. Participants receive a one-time administration of intranasal oxytocin (or~     placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of~     complex social cognition, in conjunction with functional magnetic resonance imaging (fMRI).~     We will investigate the effects of oxytocin (versus placebo) on the behavioral and neural~     correlates of empathic accuracy.~   "
181953|NCT01183208|"~     A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group,~     Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to~     Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine;~     and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following~     Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of~     PSD502 or Placebo~   "
181954|NCT01183182|"~     This study is designed to provide clinical data regarding safety and clinical effectiveness~     of the ActiSight Needle Guidance System in assisting radiologically guided percutaneous~     needle biopsy or aspiration of pulmonary lesions, which is a common procedure.~   "
181955|NCT01183169|"~     The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who~     have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may~     benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus~     placebo with PEG and RBV.~   "
181956|NCT01183156|"~     The aim of this study is to compare the effect of reminding letter and educational~     intervention on attendance to screening colonoscopy in nonresponders to initial invitation to~     screening colonoscopy.~   "
181957|NCT01183143|"~     This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the~     convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating~     hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also~     in in-vitro fertilization (IVF).~   "
181958|NCT01183130|"~     The aim of the study is to examine whether electronic compliance monitoring in real time~     could offer some advantages compared to normal electronic monitoring in opioid substitution~     treatment. The investigators would also like know whether this method could enable the quick~     detection of possible problems in medication intakes and/or prevent the abuse or diversion of~     substitution medications.~   "
181959|NCT01183117|"~     The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis~     S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA~     (balloon angioplasty). If SM-01 is used in a PTA-bailout patient, the case will be assessed~     separately.~   "
181962|NCT01183078|"~     Hypothesis: Utilization of the wand method will enhance improvements in drill placement,~     locking nail placement during tibia and femur fracture repairs, and offer less radiation~     exposure and less operative time. The purpose of this research study is to compare the~     efficacy of distal locking of intramedullary nails using a standard free-hand technique with~     the guided wand technique. Distal locking is the placement of screws through the~     intramedullary rod to hold it in place and prevent rotation. Currently, the free-hand~     technique is most often utilized. With this technique, the surgeon uses intraoperative x-rays~     in order to find the holes in the intramedullary rod to place the screws. The wand technique~     uses electromagnetic fields rather than x-rays to find these screw holes. The utilization of~     the wand technique could result in improvements in drill placement and locking nail placement~     as well as decrease operative time and radiation exposure.~   "
181963|NCT01183065|"~     The purpose of this study is to find out if the experimental drug pralatrexate with the~     vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer.~     The reason we are doing this study is because another drug called methotrexate has been used~     for a long time to treat head and neck cancer patients. Pralatrexate was designed by~     scientists to be a new drug that works better than methotrexate. Laboratory studies have~     shown that pralatrexate works better than methotrexate at killing cancer cells.~      Pralatrexate has already been studied in patients with other types of cancers, such as~     lymphoma and lung cancer. The results from those studies were promising. Pralatrexate was~     recently approved by the Food and Drug Administration (FDA) as a new treatment for a cancer~     called peripheral T cell lymphoma.~   "
181964|NCT01183052|"~     The purpose of this study is to understand the underlying mechanisms of improved exercise~     tolerance in COPD patients after training program.~   "
181965|NCT01183039|"~     The purpose of this study is to understand underlying mechanisms of improved exercise~     tolerance in Healthy Sedentary Subjects after training program.~   "
181966|NCT01183026|"~     The objective of the study was to assess diagnostic performance of V/Q SPECT for the~     diagnosis of pulmonary embolism by comparing V/Q SPECT results to a validated diagnostic~     strategy.~   "
181967|NCT01183013|"~     The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30~     weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual~     monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and~     linagliptin (5 mg, administered orally once daily). In addition, durability of treatment~     effect and safety under chronic treatment conditions will be investigated.~   "
181968|NCT01183000|"~     Objective: To determine the effect of non-closure of the visceral and parietal peritoneum~     during Cesarean section on the formation of adhesions.~      Study design: A prospective randomized trial of 533 women undergoing primary Cesarean~     section; 256 were randomized to non closure and 277 to closure of the peritoneum. At a~     subsequent cesarean,he presence of adhesions and their severity was evaluated at several~     sites: between the layers of the abdominal wall, between the bladder and the abdominal wall,~     between bladder and uterus, between the uterus and the abdominal wall, and between the bowels~     and the pelvic organs. A cumulative adhesion score was calculated.~   "
181969|NCT01182987|"~     The SCAN Memory Program Evaluation study is an evaluation of a randomized controlled trial~     intervention consisting of a care management program for cognitively-impaired health plan~     members and for their informal/family caregivers. The program includes collaboration between~     the health plan, partnering medical groups, and community organizations.~      Program activities include: 1) telephonic-structured assessments with informal caregivers~     conducted by SCAN Memory Program care managers; 2) problem identification as a result of~     these assessments; and 3) pre-established protocols and procedures for problem resolution.~     ACCESS, the prototype for the SCAN Memory Program, was developed and tested in San Diego~     County and was very successful in helping affected patients and their caregivers.~   "
181970|NCT01182974|"~     The investigators will examine the toxicity of therapeutic doses of paracetamol in patients~     in severe sepsis. Patients with fever and severe sepsis will be randomized to receive~     paracetamol or dypirone. The investigators will monitor blood glutathione and liver enzymes~     to look for potential toxicity.~   "
181971|NCT01182961|"~     The study aims to investigate the efficacy of gait training using virtual reality to decrease~     the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training~     with virtual reality would increase the ability to perform in the real world environment~     and decrease the risk of falls in elderly adults.~   "
181972|NCT01182948|"~     The purposes of this study are: a) to compare the effects of supervised programs of aerobic~     training or resistance training on the metabolic control of type 2 diabetes; b) to~     investigate some potential pathophysiologic and molecular mechanisms underlying these~     effects; c) to assess whether some changes may persist over time after termination of the~     supervised programs.~   "
181973|NCT01182935|"~     Subjects with elevated serum triglycerides in the 4th Tromso study in 1994/1995 were~     re-examined with an oral glucose tolerance test to see predictive value of triglycerides~     regarding development of type 2 diabetes~   "
181974|NCT01182922|"~     The purpose of the study is to investigate whether the information about a doctor or~     possibility to choose doctor's gender included in invitation letter is associated with~     attendance rate to screening colonoscopy.~   "
181982|NCT01182805|"~     The purpose of this study is to evaluate a novel ultrasound system's ability to assess the~     relaxing properties of the heart compared to current techniques.~   "
181996|NCT01182623|"~     It is current practice to remove any polyps found during colonoscopy. This is because~     adenomatous polyps have the potential to turn into cancer. However, a proportion of polyps~     <10mm in size are hyperplastic, which cannot turn into cancer. Current practice requires~     these to be removed, as it is traditionally felt that they cannot be separated clinically~     from adenomas. This increases the risk of perforation and results in a significant cost in~     processing the samples. However, it has been suggested that it is possible to differentiate~     neoplastic from non neoplastic lesions using skills in polyp surface pattern recognition. If~     this is the case the investigators may be able to reduce the need for polypectomy The~     investigators believe that it is possible to tell the difference between polyps with~     cancerous potential and those that are harmless by assessment of surface patterns. This may~     enable us to improve the investigators clinical decisions when assessing polyps during~     colonoscopy, and reduce the number of unnecessary polypectomys being performed.~   "
181975|NCT01182909|"~     Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in southern China~     and Southeast Asia. While infection with Epstein-Barr Virus (EBV) is believed to be necessary~     for the development of NPC, non-viral environmental factors have also been implicated to~     increase the risk of NPC including consumption of salted fish and other nitrosamine~     containing preserved foods, formaldehyde and wood dust exposure, and cigarette smoking. In~     addition to environmental factors, it is widely accepted that genetic susceptibility also~     plays an important role in the pathogenesis of NPC. Polymorphisms in genes involved in~     nitrosamine metabolism and DNA repair have been suggested to be associated with NPC risk, and~     various chromosomal regions linked to NPC development have been reported. These associations~     highlight the role of both environmental and genomic components in the etiology of NPC.~      There is a longstanding history of international collaborative studies to elucidate the role~     of environmental and genetic factors associated with NPC between investigators in Taiwan and~     the USA. A case-control study (375 cases; 327 controls) was conducted in the early 1990s, and~     a large multiplex family study that was completed in 2006 (358 families; 3,216 individuals).~     Results from these studies have provided some of the most comprehensive epidemiological~     evidence regarding factors linked to NPC development to date.~      As a next logical step, the opportunity now exists to undertake a genome-wide association~     study of NPC in Taiwan with carefully collected environmental exposure data to systematically~     examine environmental and genetic factors associated with NPC, and to evaluate gene-gene and~     gene-environment interactions. The investigators propose a case-control study of 2000 NPC~     cases (both retrospective [n=800] and prospective [n=1,200]) and 2,000 age-gender-matched~     hospital controls in northern Taiwan. The study objectives are to: 1) evaluate putative~     environmental exposures and NPC; 2) assess the effect of genetic factors, including both~     single nucleotide polymorphism and copy number variation through analysis of both main effect~     and gene-gene interaction; 3) investigate gene-environment interactions by testing for~     interactions between significant genome-wide genetic variations and EBV and other identified~     environmental risk factors; and 4) examine the natural history of EBV infection.~   "
181976|NCT01182883|"~     Background:~      - IMC-A12 is an experimental substance designed to inhibit a protein called Type I~     Insulin-Like Growth Factor Receptor (IGF-1R), which can be found on cancer cells and can~     promote cancer growth. Temsirolimus is a drug that the U.S. Food and Drug Administration has~     approved to treat advanced renal cell carcinoma in adults. Researchers do not know if the~     combination of IMC-A12 and temsirolimus will work in children, but want to determine whether~     these two drugs may be an effective treatment for recurrent tumors.~      Objectives:~        -  To determine the safety and effectiveness of IMC-A12 and temsirolimus in treating~          children and adolescents with solid tumors.~        -  To determine possible side effects of the combination of IMC-A12 and temsirolimus.~      Eligibility:~      - Children and adolescents between 12 months and 21 years of age who have solid tumors that~     have not responded to or have relapsed after standard treatment.~      Design:~        -  Participants will be screened with a medical history, physical examination, and imaging~          studies.~        -  Participants will receive IMC-A12 and temsirolimus in 28-day cycles of treatment.~          IMC-A12 will be given as an infusion over 1 hour, once a week, for 4 weeks. Temsirolimus~          will also be given after IMC-A12 over 30 minutes, once a week, for 4 weeks.~        -  Participants may continue to receive IMC-A12 and temsirolimus for up to 2 years unless~          serious side effects develop or the treatment stops being effective.~        -  Participants will have additional physical exams, blood and urine tests, and imaging~          studies regularly during each treatment cycle.~        -  Participants will be followed at regular intervals after the end of the study to collect~          tumor response and progression data....~   "
181977|NCT01182870|"~     Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if~     they were ill with influenza during the winter season 2009/2010 to see if vitamin d~     supplementation prevented flu like disease.~   "
181978|NCT01182857|"~     Background:~        -  Severe combined immunodeficiency (SCID) is a rare inherited disorder in which certain~          white blood cells have impaired function and are unable to properly fight infections.~          SCID typically appears within the first year of life and is characterized by multiple,~          recurrent severe infections. More than 10 percent of all cases of SCID involve a~          deficiency of an enzyme called adenosine deaminase (ADA), and these SCID patients also~          tend to have impaired brain function or psychiatric disorders. Researchers are~          attempting to treat ADA-SCID patients with an experimental gene therapy, and a research~          protocol has been established for those who are participating in this therapy.~        -  Little is known about quality of life in individuals with ADA-SCID, but researchers~          believe that the effects of the disease and the treatments may cause a decreased quality~          of life in both patients and their parents. Another potential cause of decreased quality~          of life in ADA-SCID is the associated psychiatric and neurological problems caused by~          the disease. Researchers are interested in studying quality of life in individuals with~          ADA-SCID and their parents to provide more information about the disease.~      Objectives:~        -  To evaluate whether gene therapy alters the quality of life or neuropsychiatric status~          of children with ADA-SCID.~        -  To monitor for intellectual, attention, memory, or specific learning disorders in~          children with ADA-SCID.~        -  To evaluate whether undergoing gene therapy has an effect on parenting stress of parents~          whose children have ADA-SCID.~      Eligibility:~        -  Children who are participating in the ADA-SCID gene therapy research protocol~          (01-HG-0189).~        -  Parents of children who are participating in the ADA-SCID gene therapy research protocol~          (01-HG-0189).~      Design:~        -  All of the testing and questionnaires will be done in the pediatric or adult clinic.~        -  Participating children will have tests of intelligence, manual dexterity, reaction time,~          basic reading and arithmetic skills, speech, and memory. These tests will be given~          before the start of the therapy, and then once a year for 5 years.~        -  Participating children will also complete questionnaires on quality of life. These~          questionnaires will be given before the start of the therapy, 3 months and 6 months~          after the therapy, and then every 6 months for a total of 5 years.~        -  Additional psychological tests may be given at the discretion of the study researchers.~        -  Parents will complete questionnaires to provide background medical information and~          report on quality of life and parental stress. The background information questionnaires~          will be given at the start of the therapy and then once a year for 5 years, the parental~          stress questionnaires will be given at the start of the therapy and then every 6 months~          for 5 years, and the quality of life questionnaires will be given at the same time as~          the child quality of life questionnaires.~        -  This protocol is separate from the gene therapy treatment protocol....~   "
181979|NCT01182844|"~     Obesity and metabolic syndrome are linked by inflammation. Gut flora seems to play an~     important role in the development of inflammation and metabolic syndrome in obesity.~     Modulation of gut flora by probiotics has been shown in animal studies to positively~     influence inflammation and metabolic disturbances.~      Lactobacillus casei Shirota is able to decrease metabolic endotoxemia by altering gut flora~     composition and gut permeability which leads to an improvement in neutrophil function and~     insulin resistance in obesity.~      The aim of the current study is to investigate the effect of Lactobacillus casei Shirota~     supplementation over 12 weeks on neutrophil function (phagocytosis, oxidative burst and TLR~     expression) in patients with metabolic syndrome.~      Furthermore the investigators aim to investigate the effect of Lactobacillus casei Shirota~     supplementation over 12 weeks on glucose tolerance, insulin resistance, inflammation, gut~     flora composition, gut permeability, and endotoxemia in metabolic syndrome~   "
181980|NCT01182831|"~     Coeliac plexus neurolysis (CPN) is a management option for pain control in carcinoma~     pancreas.CPN is conventionally performed by percutaneous technique with fluoroscopic~     guidance. Endoscopic ultrasound (EUS) is increasingly used for CPN as it offers a better~     visualization of the plexus. There are limited data comparing the two modalities.The patients~     are on follow-up for 6 months post neurolysis.~   "
181981|NCT01182818|"~     More than one million people in Europe suffer from a stroke every day. Normally older people~     have a stroke, but also a significant number of younger people between 18 and 55 years.~     Usually, these can only be explained for a minority by the classical risk factors such as~     diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of~     the younger stroke patients the etiology can be an undiagnosed genetic disease, e.g. Fabry~     disease. Fabry disease is a lysosomal storage disorder known to cause vasculopathy. The~     purpose of this study is to determine in a large number of young stroke patients, how many~     strokes were caused by Fabry disease and what risk factors might be able to predict this~     disease.~   "
181983|NCT01182792|"~     Diseases associated with chronic hypoxemia like chronic obstructive pulmonary disease (COPD)~     or emphysema, represent major medical and socio-economical problems and one of the leading~     cause of morbidity and mortality in the western countries. Recently, is has been shown that~     cardiovascular (CV) diseases contribute highly to the morbidity and mortality of these~     patients. Furthermore, increasing evidence suggest that systemic vascular dysfunction play a~     central role in the mediation of the increased CV risk in patients with COPD. However the~     underlying mechanisms of vascular dysfunction in these patients are incompletely understood.~     Chronic mountain sickness (CMS) is characterized by chronic hypoxemia related at least in~     part to hypoventilation; it affects relatively young adults, and may therefore allow to study~     the effects of chronic hypoxemia. The investigators therefore will assess systemic vascular~     function and test the hypothesis that increased oxidative stress is responsible for this~     dysfunction. Since polyglobulia is a hallmark of chronic hypoxemia and has been suggested to~     affect vascular function, the investigators will test the effects of hemodilution on vascular~     function. Then, the investigators will test the effects of acute oxygen application and 1~     month antioxidative dietary supplement on vascular function.~      Preliminary data suggest that offspring of CMS patients may display pulmonary and systemic~     vascular dysfunction. Antioxidant administration is know to improve vascular function. We~     will test the acute effect of Vitamin C in this setting.~      Finally, since there is considerable inter-individual variability of pulmonary artery~     pressure among CMS patients and the presence of a patent foramen ovale (PFO)is increased in~     clinical conditions associated with pulmonary hypertension and hypoxemia, we will assess the~     prevalence of PFO in healthy high altitude dwellers and in CMS patients and its effects on~     pulmonary artery pressure at rest and during mild exercise.~   "
181984|NCT01182779|"~     This study is a prospective randomised clinical phase III trial. The primary objective of~     this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas is~     superior to the standard proton treatment with respect to the local-progression free survival~     (LPFS).~   "
181985|NCT01182766|"~     This research study aims to test whether topiramate (a drug that is being used for seizure)~     will help individuals who have problems with both alcohol and nicotine. The investigators~     believe that individuals taking topiramate will be more successful at abstaining from both~     alcohol and nicotine than individuals taking placebo.~   "
181986|NCT01182753|"~     The study is a prospective randomised clinical phase III trial. Proton therapy is the gold~     standard in the treatment of low and intermediate grad chondrosarcomas of the skull base.~     However, high-LET beams such as carbon ions theoretically offer biologic advantages by~     enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to~     compare two different particle therapies, i.e. proton and carbon ion therapy directly with~     each other. The aim of this study is to find out, whether the biological advantages of carbon~     ion therapy mentioned above can also be clinically confirmed.~   "
181987|NCT01182740|"~     The investigators will compare the success rates of endotracheal intubation in a simulated~     entrapped car accident victim (manikin) using different video laryngoscopes by experienced~     emergency physicians.~      The investigators hypothesized that video laryngoscopes may improve success rates.~   "
181988|NCT01182727|"~     Being obese is a common problem for people with schizophrenia. People with schizophrenia are~     more likely to be overweight compared to the general population. Being overweight is a major~     risk factor for developing type II diabetes. Approximately 15% of people with schizophrenia~     have type II diabetes. People with type II diabetes have problems with their body's insulin.~     Insulin is a hormone produced by the body to control blood sugar level. Obesity and type II~     diabetes are strong risk factors for heart disease. In type II diabetes the body does not~     respond to insulin correctly. Obesity, type II diabetes, and insulin resistance are all~     common states of inflammation. Inflammation is a reaction by the body to irritation, injury,~     or infection.~      Salicylates are non-steroidal anti-inflammatory drugs. Aspirin is an example of a salicylate.~     These drugs work by decreasing the level of inflammation in the body. Salicylates have been~     shown to decrease inflammation and improve the body's response to insulin. Improving the~     body's response to insulin and decreasing inflammation could possibly reduce the risk of~     developing type II diabetes. Salicylates have been known for years to be effective for the~     treatment of diabetes. Salicylates increase the body's response to insulin causing blood~     sugar levels to decrease. Many salicylate drugs have side effects including stomach~     irritation and increased risk of bleeding. The drug for this study is called salsalate and is~     different from other salicylates. Salsalate has a lower bleeding risk than aspirin. Salsalate~     has been used to treat arthritis and has been shown to be safe.~      There have been no studies using salsalate in people with schizophrenia. The purpose of this~     study is to gain experience in the use of salsalate in people with schizophrenia. The study~     would be a pilot study to obtain preliminary data. The study would be a 6-week study where~     everyone in the study would receive the drug salsalate. The participants in the study will~     have tests of baseline symptoms of schizophrenia, a physical exam, EKG (to check heart~     function), and a side effect checklist for possible side effects from salsalate. The study~     will also have some blood drawn to measure blood sugar levels, insulin levels, and~     inflammatory markers.~   "
181989|NCT01182714|"~     Total abdominal hysterectomy is a common gynaecological operation performed worldwide. In~     Hong Kong, it was the most common gynaecological open procedure done and the number of~     hysterectomies performed increased by almost 50% in 2004 when compared to 1999. In-dwelling~     catheter use after uncomplicated abdominal hysterectomy has been the standard method for~     bladder treatment after the operation. It is traditionally advocated to assess urinary output~     and to prevent post-operative urinary retention as patients with abdominal wound are unable~     to increase the intra-abdominal pressure to aid voiding. However, in-dwelling catheters have~     been associated with increased white cell counts and higher rates of positive urine cultures,~     and subsequently urinary tract infection can lead to increased morbidity, duration of~     hospital stay, and overall healthcare cost.~      Duration of catheter use post-operatively is generally based on custom rather than~     evidence-based knowledge and therefore varies considerably. The current practice of the~     investigators hospital is to leave an in-dwelling catheter in-situ for 24 hours after an~     uncomplicated open gynaecological surgery. Schiotz et al showed that twenty-four-hour~     catheterization after common gynaecological procedures was associated with a low rate of~     voiding problems after catheter removal. Post-operative urinary retention leading to bladder~     atony may increase the long-term morbidity through increased risk of infection, detrusor~     instability and voiding difficulties. In-dwelling catheter in the immediate post-operative~     period will help to combat this problem. However, this has to be balanced against the~     potential risk of catheter-associated urinary tract infection which varies from 5% to 43% in~     the published trials.~      A prospective randomized study comparing immediate versus delayed catheter removal following~     hysterectomy showed that delayed removal after operation was not associated with an increased~     rate of febrile events or urinary tract infections, but a significantly higher subjective~     pain assessment. The size of the catheter used was 16F which was not the standard 12F that~     the investigators used in the investigators hospital setting. It is postulated that if a~     smaller caliber in-dwelling catheter is used, it will not result in an increased subjective~     pain assessment, and the catheter can be left in-situ for 24 hours without causing increased~     adverse outcomes but possibly reducing recatheterisation rate post-operatively.~   "
181990|NCT01182701|"~     The proposed study is a two arm randomized controlled trial with longitudinal follow-up that~     compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The~     experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs.~     Control) by Time (Pre, Post, Follow Up).~   "
181991|NCT01182688|"~     This study is designed to demonstrate the value of Procalcitonin (PCT) in assisting the rapid~     diagnosis of post- operative infection that includes elevation of Procalcitonin above and~     beyond the changes seen with the acute and inflammatory response induced by cardio-pulmonary~     bypass.~      Procalcitonin is an innovative and highly specific biomarker for clinically relevant severe~     bacterial infections and sepsis. PCT supports early diagnosis and clinical decision~     making.This is a prospective single center study designed to assess the normal change in PCT~     levels following major surgery and the utilization of PCT regarding the diagnosis of~     infection and the response to treatment, following major cardiac surgery~   "
181992|NCT01182675|"~     The goal of this study is to develop a novel approach to hematopoietic stem cell~     transplantation for children with Severe Combined Immunodeficiency Disease (SCID) that~     eliminates the use of toxic chemotherapy conditioning and maximizes the likelihood of T and B~     cell immune reconstitution. Rather than classic chemotherapeutic agents, the investigators~     will utilize a targeted stem cell mobilizer, plerixafor, in combination with alemtuzumab, a~     monoclonal antibody. Correlative scientific questions will include: 1) efficacy and~     characteristics of host stem cell mobilization; and 2) alemtuzumab pharmacokinetics in very~     young children.~   "
181997|NCT01182610|"~     This is an open-label, Phase II, single-stage study evaluating the use of panitumumab,~     paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal~     adenocarcinoma. The expectation is that this combination will both increase potential overall~     survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease~     potential surgical mortality by eliminating pre-operative radiation therapy.~   "
181998|NCT01182597|"~     Endoscopic hemostasis has been documented by a number of clinical studies to be effective in~     decreasing rebleeding, need for emergency surgery, and hospitalization days. Studies showed~     adjuvant treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis~     reduced recurrent ulcer bleeding. However, the optimal dose and route of adjuvant PPI therapy~     remains controversial. A recent study demonstrated frequent oral PPI offered similar acid~     control as currently recommended intravenous infusion PPI did in patients with bleeding~     ulcers. The investigators hypothesize that an frequent oral PPI treatment has similar benefit~     as proton pump inhibitor infusion in patient with bleeding ulcers after combined endoscopic~     hemostasis.~   "
181999|NCT01182584|"~     Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy.~     Pathogenesis involves autoimmune process. The investigators think temperatures of the area~     involved in the inflammation may change. Thus the investigators plan to take temperature~     pictures of Graves' patients using digital infrared thermal imaging system and observe the~     change.~   "
182000|NCT01182571|"~     The purpose of this study is to explore the fatigue, uncertainty, depression and quality of~     life in heart transplant recipients, and associated factors of quality of life .~   "
182001|NCT01182558|"~     The purpose of this investigator-initiated study is to determine the effect of prior muscle~     activation on the response obtained by nerve conduction studies (the compound muscle action~     potential [CMAP]) looking at the amplitude, area, and duration of the CMAP and evaluating the~     length of time the CMAP is larger than at baseline. On the opposite side, the corresponding~     CMAP will be tested periodically, but there will be no muscle activation on that side.~      Null Hypothesis: While controlling all possible technical and other known physiological~     variables, prior activation of a muscle has no effect on the amplitude and area of the~     compound muscle action potential (CMAP); and the CMAP does not change over time in the~     relaxed muscle (on the opposite side).~      The investigators suspect that there is an effect of prior activation of the muscle on the~     subsequent CMAP recorded from that muscle.~   "
182002|NCT01182545|"~     The investigators postulated that the use of hyperventilation after induction of anesthesia~     before CO2 insufflation for laparoscopic surgery in Trendelenburg position would maintain~     normocapnia and reduce the hemodynamic percussion response of CO2 insufflation.~   "
182003|NCT01182532|"~     The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine~     (TCM) for treatment of hand, foot, and mouth disease (HFMD).~   "
182004|NCT01182519|"~     The purpose of this study is to find out if there is a link between cigarette smoking,~     inflammation and the spread of breast cancer to the lung. We think that women who are current~     or former smokers may be at increased risk for breast cancer spreading to the lung compared~     to women who have never smoked. Smoking causes inflammation in the lung in some women.~     Researchers at Memorial Sloan-Kettering (MSKCC) think that smoking-related lung inflammation~     may increase the chance of breast cancer spreading to the lung. In order to find out whether~     inflammation plays a role in breast cancer spreading to the lung, we will measure a urinary~     marker of lung inflammation. This will allow us to determine if this marker is more commonly~     elevated in women with breast cancer that has spread to the lung compared to those without~     breast cancer in the lung. We will also collect DNA from blood to have the opportunity to~     determine if there are differences in DNA in women with or without breast cancer that has~     spread to the other sites including the lung. We will also collect blood to determine if we~     can identify risk factors for the spread of breast cancer to the lungs.~   "
182005|NCT01182506|"~     The purpose of this study is to test a memory training program for breast cancer survivors~     who have problems with memory after receiving chemotherapy. Since breast cancer survivors~     have been reported to have trouble with their memory, a program to help these problems is~     important. Studies have shown that a 5-week software training program improved memory in~     pediatric cancer survivors and other disorders like stroke, but it has not been tested for~     breast cancer survivors. This study will see if breast cancer survivors can improve their~     memory and attention problems by using either one of two software versions of the program.~     One version is called Cogmed Working Memory Training, and the other is a comparison version~     of the software that has the same exercises but is less difficult. People who decide to~     participate in the study will be randomly given one of the two versions.~   "
182006|NCT01182493|"~     The purpose of this study is to evaluate the comparative effectiveness of insulin pump~     therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are~     sub optimally controlled with multiple daily injections (MDI).~   "
182007|NCT01182480|"~     This proof of concept study proposes to evaluate the feasibility of a~     communications-technology-based chronic care and patient relationship management program to~     improve diabetes self management among adult diabetic patients in an urban safety net~     population by providing between-visit reminders and chronic disease support through cell~     phone text messaging.~      The investigators hypothesize that diabetic patients enrolled in the program will be less~     likely to miss scheduled appointments and will have greater perceived self-efficacy and~     improved patient satisfaction concerning chronic disease management. No-show rates among~     patients enrolled in the program are expected to be lower than among patients receiving~     standard care.~   "
182008|NCT01182467|"~     Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S.~     The disease can vary in severity and multiple drug classes are available to the disease~     depending on disease severity and complications. Our purpose will be to study how PET-CT~     scans can be used to better manage Crohn's Disease.~   "
182009|NCT01182454|"~     Blood pressure meter model CH-658 was to be assessed against the standard mercury~     sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.~   "
182132|NCT01180855|"~     The specific aims of the proposed study are to compare the sleep, daytime functioning, and~     circadian phase effects of ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin~     receptor agonist in humans alone and in combination with multi-component behavior therapy~     (MCBT) in patients with chronic insomnia.~   "
182010|NCT01182441|"~     This is a prospective, randomized, multicenter study to provide additional information on the~     safety and efficacy of the WATCHMAN LAA Closure Technology.~      The PREVAIL study was amended to initiate a prospective, non-randomized continued access~     study titled Continued Access to PREVAIL (CAP2) to collect additional information on the~     safety and efficacy of the WATCHMAN LAA closure technology. The study is estimated to enroll~     an initial cohort of 300 subjects with a maximum of 1500 subjects, at 60 investigational~     sites in the U.S.~   "
182011|NCT01182428|"~     The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus~     Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on~     clinical outcomes in the treatment of female patients with de novo coronary artery lesions,~     and the characterization of the female population undergoing stent implantation with a XIENCE~     stent.~   "
182012|NCT01182415|"~     Current standard treatments for lymphoma involving the central nervous system include~     chemotherapy or whole brain radiation therapy (WBRT). However, many patients do not respond~     to this treatment, and some of the patients who do respond relapse after treatment.~      Previous research has shown that a stem cell transplant of a patient's own cells (autologous~     stem cell transplant) may be more effective for some patients with lymphoma involving the~     CNS. In previous research using autologous stem cell transplants for lymphoma involving the~     CNS, a conditioning regimen consisting of the drugs thiotepa, busulfan and cyclophosphamide~     (TCE) was used. These drugs have been shown to enter the nervous system.~      In this research study, the investigators are adding the drug rituximab (Rituxan) to the drug~     cytarabine for the stem cell mobilization process. Cytarabine is a standard drug for~     mobilization. In addition, rituximab will be added to the conditioning regimen of thiotepa,~     busulfan and cyclophosphamide. Rituximab is approved by the FDA for the treatment of some~     types of lymphomas, but is not approved for use in lymphomas that involve the CNS. Rituximab~     is known to be able to enter the CNS. Previous research has suggested that it may help treat~     lymphoma that involves the CNS.~      The goal of this research study is to see if adding rituximab to the stem cell mobilization~     and conditioning regimens helps treat lymphoma that involves the central nervous system.~   "
182013|NCT01182402|"~     The purpose of this study is to improve unsupervised dosing of opioid substitution~     medications. The aim of the study is to examine whether electronic compliance monitoring~     provides some advantages to patients`treatment and what kind of patients especially benefit~     from monitoring. We would also like to know if electronic compliance monitoring can prevent~     the abuse/diversion of medications and how implementing this method to wider treatment~     facilities succeeds.~   "
182014|NCT01182389|"~     Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack~     and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an~     implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's~     rhythm back to normal by electrically stimulating the heart but in doing so gives the patient~     painful and debilitating shocks. The first ICD shock after implantation appears to be a~     powerful predictor of subsequent shock therapy as well as being a predictor of of increased~     mortality in patients with primary prevention ICDs. In patients who receive repeated shocks~     VT ablation is performed to 'burn' the abnormal area of the heart that causes the problem.~     However, it is often only performed as a last resort as it is technically challenging. We~     believe that performing VT ablation using the robotic system early after the first episode of~     VT after ICD implantation, may reduce the number of painful shocks received by the patient~     and possibly increase life expectancy and quality of life.~      200 patients from 5 european countries will be recruited in a prospective, open, randomised~     trial. Eligible, consenting patients who have experienced their first episode of VT since ICD~     implantation, will be randomised in a 1:1 manner into treatment arms of either VT ablation or~     standard 'conventional' therapy and followed-up every 4 months over two years to assess the~     number of subsequent ICD shocks, hospitalisation, mortality and quality of life.~   "
182015|NCT01182376|"~     The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in~     the slowing of progression of left atrial and ventricular fibrosis in patients with atrial~     fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.~   "
182016|NCT01182363|"~     This application to the Boston University Medical Center Institutional Review Board outlines~     a research plan devoted to identifying and managing maternal depression in Early Intervention~     (EI). The target population is women who's children are enrolled in early intervention who~     have experienced an adverse pregnancy outcome, defined as the birth of a child who was born~     prematurely, low birth weight, or with birth defects. Early intervention provides~     developmental services to the state's birth to three population under the Part C of the~     Individuals with Disabilities Act (IDEA). Our intervention strategy involves the~     identification of mothers whose children receive early intervention services and who,~     themselves, are at risk for depression. Eligible mothers will be offered a preventative~     intervention that involves the principles of Problem Solving Treatment (PST). Problem Solving~     Treatment is a brief skills-building psychotherapeutic intervention that focuses on specific~     daily problems, and applies to these problems a structured approach to finding and evaluating~     solutions.~      This study will be a parallel group randomized control trial (RCT) of 188 mother-child dyads.~     Mothers in the intervention group will receive 6 sessions of Problem Solving Treatment, which~     will be referred to as Problem Solving Education (PSE) in this application. The women in the~     control site will receive usual care. Problem Solving Education interventionists (Problem~     Solving Educators or PS Educators) will conduct Problem Solving Education with mothers of~     children who receive early intervention services through Thom Child and Family Services, Bay~     Cove Early Intervention program, South Shore Mental Health (Step One Early Intervention), and~     Meeting Street Early Intervention with an enrollment goal of 188 mothers. In addition to~     engaging in Problem Solving Education sessions, mothers who agree to participate in the study~     will meet with research staff to complete 1)baseline assessment measures at study enrollment~     and 2) outcome assessment measures 3 months after baseline assessment and 3) outcome~     assessment measures 6 months after baseline assessment.~   "
182036|NCT01182103|"~     The investigators will (1) detect the associations between brain-derived neurotrophic factor~     (BDNF) DNA methylation, histone modification, depressive symptoms, suicidal behavior and~     antidepressant responses in major depressive disorder (MDD) patients, (2) check the~     correlation between blood BDNF protein and RNA and BDNF rs6265 gene, and (3) discuss the~     possible mechanisms of epigenetic regulation of BDNF in Taiwanese major depressive patients.~   "
182037|NCT01182090|"~     Objective:~      This prospective randomized trial evaluated outcomes of colposacropexy performed either by~     open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical~     techniques, efficacy and overall results are compared.~      Methods:~      In this prospective study 40 consecutive patients with uro-genital prolapse are randomized to~     sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. Anchorage is~     achieved in both groups by two polypropylene meshes.~      Check-ups were scheduled at 3, 6, 12 months and then yearly. Pre-operative patient~     characteristics, operative and post-operative events and follow-up results are recorded.~   "
182017|NCT01182350|"~     The primary objective of this study is to estimate the overall survival of children and young~     adults with diffuse intrinsic pontine glioma treated (DIPG) with a molecularly based~     treatment strategy, compared to historical controls.~      Four Biopsies of tumor tissue will be obtained by surgical biopsy prior to treatment~     stratification if tolerated. An MRI-guided frameless or frame-based stereotactic biopsy will~     be performed approaching the pontine termentum through a trans-cerebellar or trans-frontal~     route. The exact biopsy location will be determined by the treating neurosurgeon at the~     designated participating site with the goal of minimizing procedural risk.~      Following biopsy,all patients will receive local radiotherapy to consist of 59.4Gy delivered~     using conventional conformal or other standard treatment planning with adjuvant bevacizumab.~     Radiation planning can begin with the pre-operative images. Based upon molecular parameters~     after biopsy, patients will potentially receive erlotinib and/or temozolomide at the start of~     radiotherapy. Bevacizumab will be given concurrently with radiotherapy beginning at least~     three weeks from the biopsy and at least two weeks after the start of radiation therapy to~     ensure that primary wound healing has occurred. Once irradiation is complete, patients will~     have a four week interim period before beginning the maintenance phase. Adjuvant chemotherapy~     will be continued during the interim period.~      The maintenance phase (approxmiately 40 weeks) will last for 10 cycles(28 days +/- 3 days).~     Based upon molecular parameters as determined at the time of diagnostic biopsy, patients will~     continue to receive erlotinib and/or temozolomide along with bevacizumab during the~     maintenance phase.~      Stratification will be based on O6-methylguanine-DNA methyltransferase (MGMT) promoter~     methylation status and epidermal growth factor receptor (EGFR) expression in tumor biopsy~     samples. If MGMT status and/or EFGR status are not determinable, patients may be treated as~     per cohort #1(bevacizumab and irradiation) but will be analyzed separately.~   "
182018|NCT01182337|"~     Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5~     in subjects with early lumbar disc degeneration~   "
182019|NCT01182324|"~     The purpose of this study is to describe the experiences of parents, clinician researchers,~     and industry professionals who were involved in phase II clinical trials of Ataluren for~     Duchenne muscular dystrophy. We are especially interested in learning about motivations for~     being involved in the clinical trial, expectations of the trial, the experience of the trial,~     and relationships between the parents of children involved in the trial, the clinician~     researchers, and PTC Therapeutics. In addition, we would like to learn more about whether and~     how families and advocacy organizations experiences in following the progress of the drug,~     encouraging the clinical trial, and supporting the phase II trials may have affected~     participants thoughts and feelings about the study.~   "
182020|NCT01182311|"~     Background:~        -  The hepatitis B vaccine has been shown to be safe and effective in preventing~          transmission of the hepatitis B virus. Response rates to the initial three doses of the~          vaccine are high, with significant or even complete immune response. However, this level~          has been reported to decline rapidly within the first year and more slowly thereafter.~          There is little data on the durability and long-term protection provided by the~          hepatitis B vaccine administered to adults in the United States.~        -  Vaccinated individuals are believed to be protected against hepatitis B virus infection~          because of a memory immune response. Even if antibody levels are low, the immune system~          will still be able to produce enough antibody to neutralize the hepatitis B virus.~          Therefore, booster doses of the vaccine are not recommended, except for some high-risk~          individuals such as patients on dialysis. Researchers are interested in determining the~          durability of the immune response of the hepatitis B vaccine in adults with low or~          intermediate risk for hepatitis B virus infection.~      Objectives:~      - To examine the long-term immune status of human immunodeficiency virus (HIV) positive and~     negative individuals who received the hepatitis B vaccine during adulthood, compared with the~     immune status of individuals who acquired natural immunity by recovering from acute hepatitis~     B during adulthood.~      Eligibility:~        -  Individuals at least 18 years of age who were vaccinated against hepatitis B at least 10~          years ago.~        -  Individuals at least 18 years of age who contracted and recovered from acute hepatitis B~          at least 10 years ago.~        -  Individuals at least 18 years of age who have well-controlled HIV and were vaccinated~          against hepatitis B at least 10 years ago.~      Design:~        -  Participants will have a single outpatient study visit and potential follow-up visits as~          part of this protocol.~        -  Participants will complete a questionnaire assessing possible risk factors for hepatitis~          B infection, and will provide blood samples to test for hepatitis B antibodies and other~          immune system studies.~        -  Participants will receive a letter or phone call with the results of the blood tests:~        -  Those who no longer have protective levels of antibody against the hepatitis B virus~          will be offered a booster dose of the hepatitis B vaccine. To monitor immune response to~          the booster vaccine, additional study visits will be scheduled at 1 and 3 weeks~          following the booster.~        -  Those who have chronic infection with the hepatitis B virus will be advised to follow up~          with their primary care physician, and may be eligible to participate in ongoing~          treatment trials for chronic hepatitis B.~        -  Those who have abnormal blood tests will be referred back to their primary care~          physician for investigation of the abnormal tests results, and may also be referred to~          other National Institutes of Health protocols.~        -  Additional tests will evaluate immune response to the measles, mumps, and rubella~          (German measles) viruses. Some participants may be advised to have an additional MMR~          vaccine through their primary care physician.~   "
182021|NCT01182298|"~     -  Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA)~          to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who~          have not been previously treated with interferon-alpha drugs (which improve immune~          system response to infection). Ribavirin has been approved by the FDA and is usually~          given in combination with interferon drugs such as peginterferon alfa-2a for treatment~          of chronic HCV.~        -  Recent research shows that Latino whites do not respond as well to treatment with~          peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as~          excessive weight, gender, and insulin resistance were evaluated to explain this~          difference, but research suggests that underlying factors related to Latino or~          non-Latino background, possibly genetic and immune differences, may be affecting the~          response to HCV infection and treatment. However, more research is needed on the~          effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with~          combined and human immunodeficiency virus (HIV) co-infection.~      Objectives:~      - To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and~     ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV~     co-infection.~      This is an observational study. The observed treatment is received and managed through their~     primary care.~   "
182022|NCT01182285|"~     Background:~        -  Patients who have advanced thyroid cancer have a low long-term survival rate. These~          types of thyroid cancer do not respond well to conventional surgery or radiation, or to~          specific thyroid cancer treatments such as radioactive iodine treatment and thyroid~          hormone for thyroid stimulating hormone (TSH) suppression.~        -  Valproic acid has long been approved as an anticonvulsant to treat seizures in patients~          with epilepsy. It has also been used to treat bipolar disorder. Recent studies have~          shown that valproic acid has promising effects in thyroid cancer treatment because it~          may help destroy cancer cells and help conventional treatments be more effective.~          However, valproic acid is not approved for thyroid cancer and is therefore an~          investigational drug.~      Objectives:~        -  To determine whether valproic acid can inhibit tumor growth or induce tumor cell death.~        -  To determine whether valproic acid can make tumor cells increase their uptake of~          radioiodine.~      Eligibility:~      - Individuals at least 18 years of age who have advanced-stage thyroid cancer that is either~     unresponsive to conventional treatments or fails to absorb radioiodine.~      Design:~        -  Eligible participants will continue on the standard thyroid hormone suppression therapy~          and begin receiving valproic acid for a total of 10 weeks. Participants will keep a~          study diary to record doses and side effects, and will have regular clinic visits to~          provide blood samples and receive additional valproic acid.~        -  After 10 weeks, participants will have a Thyrogen scan to measure radioiodine uptake~          after valproic acid therapy. Tumor biopsies and blood samples will be taken at this~          time.~        -  If there is increased radioiodine uptake on the scan, participants will have additional~          radioiodine therapy.~        -  If there is no increased uptake on the scan, participants will continue on valproic acid~          for 7 more weeks. After 16 total weeks of treatment, additional blood samples and scans~          will be taken. Participants may continue to take valproic acid if the thyroid cancer~          appears to be responding to the treatment.~        -  Follow-up visits will be scheduled at 3, 6, 9 (for patients continuing on valproic acid~          only), and 12 months.~   "
182023|NCT01182272|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating~     patients with liver cancer that can be removed by surgery.~   "
182038|NCT01182077|"~     The objective of the study is to characterize the effect of multiple doses of ASP015K on the~     pharmacokinetics of a single dose of midazolam.~   "
182024|NCT01182259|"~     Tuberculosis remains one of the largest health problems in the world today. Multidrug therapy~     is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant~     mutants, however, which may increase the incidence of side effects during the course of~     treatment. These side effects may be mild as well as fatal. A severe side effect against one~     of the anti-TB drugs, which influences drug compliance, may lead to the discontinuation of~     that drug. At the same time, the risk of treatment failure and relapse are higher. Therefore~     monitoring the rate of anti-TB drugs induced adverse effects and the related risk factors is~     crucial. Awareness of the risk groups may decrease the incidence of serious drug-related side~     effects and medical cost.~      The fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended~     by WHO, which simplify the prescription of drugs and prevent the development of drug~     resistance. However, the FDC regimen is not consistent with the dosages that are usually~     given, the higher risk of drug toxicity and adverse reactions should be considered. To our~     knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan.~     The aim of the present study is to investigate the current incidence of side effects and the~     risk factors related to FDC drugs for side effects during the initial phase of therapy.~   "
182025|NCT01182246|"~     The purpose of this study is to assess the effect and safety of AXP107-11 alone, and in~     combination with gemcitabine standard therapy, in patients with advanced or metastatic cancer~     of the pancreas. The safety, pharmacokinetics and efficacy of AXP107-11 in these patients~     will also be studied.~   "
182026|NCT01182233|"~     The purpose of this study is to improve the efficacy of the HDC regimen by adding a novel,~     targeted means administering a variation of total body irradiation (TBI) radiation i.e.,~     total skeletal irradiation (TSI) administered by helical tomotherapy (HT) before, and in~     addition to the current standard of HDC, at a dose of 200 mg/m2 (HDMel200). The underlying~     postulate of this endeavor is that TSI-HT will provide additional cytoreduction to HDMel~     alone, without producing additional (serious) toxicity. We will utilize a classical Phase I~     study design (i.e., dose escalation) in myeloma patients undergoing AHSCT2 to define a~     maximum tolerated dose (MTD) and dose limiting toxicity (DLT). Finally, although comparisons~     to other therapies are not typical (and/or feasible) for a Phase I study, we will compare,~     whenever possible, both the toxicity and the antimyeloma activity of the AHSCT2 to AHSCT1.~      This protocol will standardize, as much as possible the use of AHSCT2 both as a tandem and~     salvage procedure. Since sufficient AHSC (CD34+ cells) are routinely collected in adequate~     numbers for multiple AHSCTs, but recently used infrequently, it is important to work towards~     defining the optimal utilization of this resource.~   "
182027|NCT01182220|"~     1. labor epidural quite often require bolus supplementation for better pain control~          control. Quite often this is due to sparing of sacral nerves.~        2. If epidural is placed low in the L5/S1 interspace using ultrasound, this may minimize~          bolus requirement and improve patient labor experience.~   "
182028|NCT01182207|"~     This study was designed to compare the relative bioavailability (rate and extent of~     absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets~     (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablets) in healthy, adult~     subjects under non-fasting conditions.~   "
182029|NCT01182194|"~     This study was designed to compare the relative bioavailability (rate and extent of~     absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets~     (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult~     subjects administered under fasting conditions.~   "
182030|NCT01182181|"~     The objective of this study is to evaluate the comparative bioavailability between~     Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca~     Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.~   "
182031|NCT01182168|"~     The purpose of this study is to test the safety of gemcitabine and cisplatin plus Everolimus~     (also called RAD001) at different dose levels. We want to find out what effects, good and/or~     bad, this treatment has on you and your cancer.~      Gemcitabine and cisplatin are standard chemotherapy drugs that are commonly used to treat~     advanced urothelial cancer. Everolimus is a pill that works by shutting down some of the~     pathways in cancer cells that make tumors grow. Laboratory studies have shown that Everolimus~     appears to improve the activity of cisplatin against cancer cells.~   "
182032|NCT01182155|"~     Patients treated with radiation therapy for lung tumors can experience inflammation after~     treatment. This study hopes to evaluate the use of breath analysis to evaluate changes in the~     composition of exhaled breath in patients undergoing radiotherapy. If changes can be~     detected, this may ultimately serve as biomarkers for identifying patients at highest risk~     for radiation-induced lung injury (radiation pneumonitis).~   "
182033|NCT01182142|"~     Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of~     metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic~     renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine~     in metastatic renal cell carcinoma patients.~   "
182034|NCT01182129|"~     Fifteen healthy smokers are given single doses of General Onyx 1 g portion snus and General~     White 1g portion snus, respectively, and one piece of Nicorette 4 mg chewing gum. Serial~     blood samples are drawn before (0), 2, 4, 8, 16, 24, 30, 45, 60 minutes, 1.5, 2, 4, 6 and 8~     hours after administration for determination of nicotine. Mean + SD extracted dose of~     nicotine from each preparation will be estimated. The percentage extracted of the nicotine~     content will be calculated. Cmax and Tmax will be estimated. A comparison to Nicorette 4 mg~     chewing gum will be made. The dose absorbed into the systemic blood circulation (AUC) in~     relation to the dose following the 4 mg Nicorette chewing gum will be calculated.~     Self-reports of subjective effects will be obtained up to 30 minutes after the test product~     is administered using a 100 mm visual analogue scale (VAS) anchored with not at all to~     extremely. Study hypothesis is that Cmax and AUC of Nicorette 4 mg chewing gum and Swedish~     snus are similar.~   "
182035|NCT01182116|"~     The investigators hypothesis is that the patients who receive a side to end anastomosis have~     bowel outcome and quality of life that is equivalent to those who receive a J pouch.~   "
182068|NCT01181687|"~     The purpose of this study is to establish reliability and validity of the Norwegian version~     of the Comfort behavioral scale.~   "
182039|NCT01182064|"~     Patients with a cardiac stab wound could be complicated by a posttraumatic acute myocardial~     infarction (PAMI). Traditionally, the investigators can explain it by the occlusion of a~     coronary artery; but the PAMI isn´t constantly related with coronary artery injuries or their~     damage in the cardiac injury repair. The investigators objectives are to know the PAMI~     incidence, make an approximation to PAMI pathophysiology, and propose management strategies.~   "
182040|NCT01182051|"~     The primary aim of this proposal is to refine the intervention under investigation (i.e.,~     family-based CBT) and evaluate the feasibility and acceptability of the intervention and~     methods (e.g., recruitment, assessments).~      The secondary aim of this proposal is to compare the relative efficacy of an 8 session~     family-based cognitive-behavioral therapy (CBT) to Relaxation Training (RT) for reducing~     anxiety and chronic headaches in youth (N = 30) ages 7-17 years. It is hypothesized that CBT~     will result in greater reductions in both anxiety and headache frequency and severity~     compared to RT.~   "
182041|NCT01182038|"~     The purpose of this study is to determine whether birth on a birthing seat will effect~     numbers of instrumentally assisted vaginal births, vaginal traumas, blood loss,use of~     artificial oxytocin for labour augmentation and fetal outcomes.~   "
182042|NCT01182025|"~     The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for~     mild type of hand, foot, and mouth disease.~   "
182043|NCT01182012|"~     Background:~      Patients with severe mental illness (SMI) have a higher prevalence of cardiovascular risk~     factors (CVRF) than the general population and a control of these risk factors poorer.~     Serious mental illness often causes health teams to focus interventions in mental illness and~     put aside the CVRF.~      Objectives:~      This project aims to assess the CVRF, stratify the cardiovascular risk, adequate drug~     treatment to reduce this risk and evaluate the effectiveness of an intervention by~     professional community nurses in patients with SMI.~      Materials and Methods:~      Prospective study of a cohort of patients over 18 years with a diagnosis of SMI with two~     cross sections to evaluate the cardiovascular risk and adequacy of drug treatment. The~     investigators calculate the risk to the cardiovascular risk tables with the SCORE (Systematic~     Coronary Risk Evaluation) for countries of low cardiovascular risk and the of Framingham~     REGICOR (Heart registry of Girona, Spain). The adequacy of pharmacotherapy will be assessed~     contrasting it with the recommendations of the Program of Preventive Activities and Health~     Promotion of Family medical association. The intervention will be conducted by professional~     nurses and consist of an initial psycho-educational intervention, and two more reinforcement~     throughout twelve months, of duration less than 30 minutes that will be addressed in an~     integrated manner the clinical situation with regard to cardiovascular risk. If necessary,~     pharmacological treatment will be prescribed. Twelve months after the first intervention, a~     second evaluation on cardiovascular risk and the effectiveness of the intervention will be~     performed.~   "
182044|NCT01181999|"~     Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)~     combination is considered as the new gold standard for the first-line treatment of elderly~     patients with diffuse large B-cell lymphoma (DLBCL).~      The study is aimed to evaluate the overall response rate and the safety of four cycles of~     R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in~     newly diagnosed DLBCL patients with aged more than 70 years.~   "
182045|NCT01181986|"~     The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes~     medication, will improve the function of the innermost part of the arterial wall called the~     endothelium after a fat-enriched meal and to determine how this occurs. The results of this~     study will help to determine and understand a novel action of this group of diabetes~     medications based on the action of naturally occuring gut substances called incretins. This~     may have a significant impact on cardiovascular health in patients with early and~     longstanding diabetes.~   "
182046|NCT01181973|"~     The hypothesis to be tested is that the bioavailability of the new 30-mg vial is similar to~     that of the current approved 15 -mg vials. In addition, the SC injection using the new 30-mg~     vial is safe and well-tolerated.~   "
182047|NCT01181960|"~     The purpose of this study is to build a data repository that can be used to understand~     pharmaceutical utilization patterns among patients being treated in community behavioral~     health organizations (CBHOs) for schizophrenia or bipolar I disorder.~   "
182048|NCT01181947|"~     The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System~     (Captivia). This new delivery system was CE marked on September 14th, 2009 and was~     commercially released in the European Union on October 1st, 2009.~      The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is~     designed to treat diseases of the descending thoracic aorta including but not limited to~     aneurysms and dissections.~      The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical~     performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market~     approval.~   "
182049|NCT01181934|"~     This study in young and elderly healthy subjects will investigate the effect of nicotine on~     arousal, cognitive task and social cognition after acute dose administration.~   "
182050|NCT01181921|"~     The purpose of this study is to assess the modulating effect of galantamine on circadian~     rhythm in patients with moderate Alzheimer's disease.~   "
182051|NCT01181908|"~     The purpose of this study is understand the effects of GSK114814 and alcohol in healthy~     volunteers when taken together.~   "
182052|NCT01181895|"~     The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation~     powder administered once daily in the evening in adolescent and adult subjects 12 years of~     age and older with persistent asthma over a 12-week treatment period.~   "
182053|NCT01181882|"~     The purpose of this study is to understand if omega-3 fatty acids in fish oil enhance the~     ability of aspirin to reduce the risk of cardiovascular diseases such as heart attack and~     stroke in those who have diabetes mellitus.~   "
182054|NCT01181869|"~     An observatory of patients registered in 22 local homecare associations in France, for~     respiratory diseases, with annual data update. Demographic and clinical data are registered~     rendering possible extraction of clinical and prognostic data.~   "
182055|NCT01181856|"~     This is a phase I study that will compare the safety and immunogenicity of candidate~     tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal~     route in healthy adult individuals who have been previously vaccinated with Bacillus~     Calmette-Guerin (BCG).~   "
182056|NCT01181843|"~     This study is designed to determine the incidence and severity of respiratory depression in~     elective cesarean section patients who have received a spinal or epidural narcotic called~     duramorph for management of postoperative pain. A monitoring device called a capnograph as~     well as a device called a pulse oximeter is placed on the patient once in the recovery room~     after delivery. The capnograph monitors the carbon dioxide level that the patient breathes~     out as well as their respiratory rate. The pulse oximeter is a device that is taped on the~     patient's finger and measures their oxygen saturation level. The monitoring is maintained for~     18-24 hours after surgery.~   "
182057|NCT01181830|"~     Magnesium is the second most abundant ion in human cells and plays fundamental roles in~     several enzymatic reactions: it is involved in ATP production, in the phosphorylation of~     proteins, in glucose metabolism and in the contraction of cytoskeleton.~      Several epidemiological studies demonstrated that low dietary magnesium intake is inversely~     associated with diabetes mellitus, hypertension and metabolic syndrome.~      Magnesium could be related to important haemodynamic and metabolic anomalies: at vascular~     level it acts as an antagonist of calcium, especially in vascular smooth muscle cells, thus~     its deficit could enhance vascular contraction; with regard to glucose metabolism, magnesium~     is involved in the physiopathological mechanism of insulin resistance, through a reduction in~     cellular uptake of glucose. This condition and the subsequent compensatory hyperinsulinemia~     can ultimately lead to increased synthesis of proinflammatory cytokines and to endothelial~     dysfunction. Thus, magnesium depletion and subsequent alterations can increase the risk of~     developing vascular disease such as atherosclerosis and has been associated with~     cardiovascular events.~      Several clinical trials have explored the possible beneficial effect of magnesium~     supplementation on blood pressure, plasma lipids and insulin resistance but the results are~     often contradictory. One of the possibilities for these unclear results could be that in some~     of them the interventions started too late when haemodynamic and metabolic changes are more~     difficult to revert.~      The investigators hypothesis is that magnesium supplementation in a population at increased~     genetic risk of developing metabolic syndrome but without it could improve blood pressure and~     the other metabolic syndrome related components.~      Thus, the aim of the present study is to evaluate the effect of oral supplementation of~     magnesium (16.2 mmol/day of magnesium pidolate) on metabolic syndrome's components in a~     sample of 15 subjects who are at increased risk of developing metabolic syndrome since have a~     positive familiar history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI~     criteria).~   "
182058|NCT01181817|"~     Functional Magnetic Resonance Imaging (fMRI)and MR Spectroscopy of the brain are perfect~     tools to investigate the changes in the brainstem and brain evoked by the orthodromically~     impulses of a SCS.~   "
182059|NCT01181804|"~     This is a single-dose, randomized, cross-sectional comparison study examining the relative~     safety and resulting blood level profiles after administration of a new boceprevir tablet~     formulation versus its current capsule formulation for treatment of chronic hepatitis C. In~     Part 1 of the study participants will receive boceprevir tablets and capsules under fed~     conditions. In Part 2 of the study a new group of participants will receive boceprevir~     tablets and capsules under fasted conditions.~   "
182060|NCT01181791|"~     This application a phase II clinical trial to address the possible active mechanisms of~     probiotics and to obtain preliminary efficacy and safety data after the administration of a~     probiotic, Lactobacillus reuteri a population of premature infants.~      The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature~     infants will lead to clinical beneficial effects by modifying their intestinal microbiota and~     enhancing their intestinal immunological response.~   "
182061|NCT01181778|"~     Physicians counsel women participants who are candidates for hormonal contraception about~     available combined hormonal contraceptive methods (the combined pill, the contraceptive~     vaginal ring [i.e., the etonogestrel + ethinylestradiol vaginal ring] and the contraceptive~     transdermal patch). Effects of this counseling on women's contraceptive use decisions are to~     be evaluated by 1) recording which method is chosen after information is provided about all~     three available combined hormonal methods, 2) comparing the final chosen contraceptive method~     used by a participant after counseling with the method originally intended to be used by that~     participant before the counseling, and 3) evaluating the criteria used by women participants~     to choose their contraceptive method after the counseling, including evaluation of social and~     demographic predictors of contraceptive choice. The differences among participants in the~     number of contacts made by the participants to physician offices for purposes of obtaining~     information regarding the use of their final chosen hormonal contraceptive (e.g., requests~     for clarification, questions, expressing doubt or reservations for using the method, or~     requests for other help/advisement by the physician) will also be evaluated over four months~     following the physician counseling.~   "
182062|NCT01181765|"~     This is a pilot study to estimate the efficacy of infliximab in inducing and maintaining~     healing of lesions in the mucosa of subjects with Crohn's disease involving their small~     bowel.~   "
182063|NCT01181752|"~     Eye drops must be proficiently instilled to prevent infections following cataract surgery.~     Proficiency is defined as placing a drop on the ocular surface without touching the~     applicator's tip. Researchers will investigate whether patients can proficiently administer~     eye drops on the first attempt on the first day after surgeries. If successful, researchers~     will determine how proficient they are 29 days later. If not, they will be provided with~     additional educational sessions and tested again 29 days later. Researchers will also~     determine if the proficiency of instillation correlates to whether patients experience~     irritation or pain after surgery.~      Summary Brief Summary Eye drops must be proficiently instilled to prevent infections~     following cataract surgery. Proficiency is defined as placing a drop on the ocular surface~     without touching the applicator's tip. Researchers will investigate whether patients can~     proficiently administer eye drops on the first attempt on the first day after surgeries. If~     successful, researchers will determine how proficient they are 29 days later. If not, they~     will be provided with additional educational sessions and tested again 29 days later.~     Researchers will also determine if the proficiency of instillation correlates to whether~     patients experience irritation or pain after surgery.~      Hypotheses:~      On postoperative day 30, there will be a higher rate of successful eye drop instillation in~     the group of subjects who receive the educational session compared to the baseline group~     subjects (subjects only tested on postoperative day 30 rather than both the first day after~     surgery and postoperative day 30) who will not receive it.~      In comparing the postoperative day 30 proficiency levels of baseline subjects and subjects~     who were able to proficiently instill a single eye drop on postoperative day 1, the subjects~     who were able to proficiently instill a single eye drop on postoperative day 1 will have a~     higher success rate than the baseline group.~      The number of subjects who are unable to correctly instill the medication on postoperative~     day 30 and experienced pain or irritation before or during postoperative day 30 will be~     higher than the number of subjects who are able to correctly instill the medication on~     postoperative day 30 and experienced pain or irritation before or during postoperative day~     30.~   "
182064|NCT01181739|"~     This study is designed to compare traditional Colonoscopy with CT Colonography, commonly~     known as virtual colonoscopy. The study will compare the ability of both procedures as~     screening tests to identify polyps in the colon in patients at average risk for developing~     polyps. The patient preferences for each procedure will be assessed by means of a~     standardized questionnaire. As well the ability observers with differing levels of experience~     to read the CT scans and detect polyps will be compared. All patients will receive both CT~     scans and traditional colonoscopy on the same day.~   "
182065|NCT01181726|"~     The objective of this study was to determine and compare the rate and extent of absorption of~     norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone~     Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg~     norethindrone acetate) Tablets under fed conditions.~   "
182066|NCT01181713|"~     The purpose of this study is to determine if antibiotic resistance of the ocular surface~     flora to the 4th generation fluoroquinolones will increase after repeated use of topical~     antibiotics for three days post intravitreal injection.~   "
182067|NCT01181700|"~     The purpose of this study is to investigate the time course of PF-00241939 concentrations in~     the blood following dosing by oral inhalation using dry powder inhalers.~   "
182071|NCT01181648|"~     The investigators are doing this study to learn about the quality of life patients have at~     the end of treatment. Some patients' cancers are related to human papilloma virus or HPV;~     others are not. HPV is a virus that can be sexually transmitted and is known to cause some~     types of cancers. If your throat cancer was related to HPV, your doctor can discuss this with~     you in detail. The investigators want to see if there are differences in quality of life~     between patients whose cancers are caused by HPV and those who cancers are not caused by HPV.~     Throat cancers caused by HPV behave differently than throat cancers not caused by HPV. The~     investigators believe that patients with these two different types of throat cancer will also~     have different experiences after completing therapy. The investigators would like to~     understand what those differences are. The long-term goal of this study is to see what~     symptoms most patients have. The investigators can then try to treat them earlier, and~     hopefully, improve the symptoms. The investigators will also be able to plan more research to~     improve treatment for symptoms following treatment for cancer of the mouth and throat.~   "
182072|NCT01181635|"~     The purpose of this study is to examine if psychotherapy can reduce sickness absence.~   "
182073|NCT01181622|"~     The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID~     in pediatric CF patients 2 to 4 years of age~   "
182074|NCT01181609|"~     This study will assess the efficacy and safety of intravenous Avastin in combination with~     chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum.~     The anticipated time of study treatment is until disease progression.~   "
182075|NCT01181596|"~     Use of a new ultrasound device designed for babies to look at the catheters in veins and~     arteries as well as the blood vessel itself. An observational study to assess the the~     clinicians perception of the ultrasound image quality as a tool to detect catheters in~     vessels.~   "
182076|NCT01181583|"~     The overall aim of this study is to develop and test a tailored Internet-delivered~     psychological treatment for patients with mild to moderate major depression and comorbid~     anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active~     control group.~   "
182077|NCT01181570|"~     This study will evaluate the effect and safety of adalimumab in approximately 20 subjects~     with mild to moderate psoriasis and sleep apnea and will be conducted in one treatment center~     located in Montreal.~      Patients with psoriasis often have additional disorders such as obesity. Obese patients are~     more at risk of developing obstructive sleep apnea. This is believed to be caused by both the~     collapse of upper airways and inflammation (swelling). Adalimumab, a drug currently approved~     by Health Canada for the treatment of psoriasis, blocks tumor necrosis factor-alpha~     (TNF-alpha). This chemical is present at higher levels in patients with sleep apnea. It is~     believed that adalimumab could improve obstructive sleep apnea by lowering the levels of~     TNF-alpha.~   "
182078|NCT01181557|"~     The aim of the present prospective study was to evaluate the prediction accuracy of EORTC~     QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to~     investigate how the quality of life (QoL) of patients with rectal cancer changes with time~     after cancer or after stomia.~      Eligible subjects were consecutively enrolled in the investigators' Institute and subjected~     to EORTC QLQ-C30/C38 questionnaire.~   "
182079|NCT01181544|"~     During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose of~     this pilot study is to determine if the amount of heparin administered during a patient's~     hemodialysis can be individualized using an equation for heparin dose adjustment.~   "
182080|NCT01181531|"~     The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage~     plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally~     or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the~     doses are adjusted appropriately to maintain serum calcium and phosphorous levels with~     currently recommended ranges.~   "
182081|NCT01181518|"~     The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by~     the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.~   "
182082|NCT01181505|"~     This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in~     healthy subject in relation to the presence of HNF-4A G60D variant.~   "
182083|NCT01181492|"~     Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on~     metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176~     patients receiving elective lower abdominal surgery under general anesthesia were recruited~     into this study. Genotyping of CYP3A4*1G was carried out by direct sequencing. The plasma~     fentanyl concentration was detected 30 min after anesthesia induction by high performance~     liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for~     pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24~     h after operation. PCA fentanyl consumption and adverse effects were recorded during the~     first 24 h after surgery.~   "
182084|NCT01181479|"~     The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal~     contraceptive delivery system containing ethinyl estradiol and levonorgestrel.~   "
182085|NCT01181466|"~     The purpose of this study is to assess the procedural and post-procedural safety and efficacy~     of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with~     GOLD Stage III/IV homogeneous or heterogeneous emphysema.~   "
182086|NCT01181453|"~     This study randomly assigns patients with diabetic foot ulcers to receive standard therapy~     (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus~     Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an~     absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment~     period is complete.~   "
182087|NCT01181440|"~     This study randomly assigns patients with plantar diabetic foot ulcers to receive~     conventional therapy (debridement, infection control, saline-moistened gauze dressings, and~     standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a~     device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh.~     Patients are evaluated weekly until Week 12, then every four weeks until Week 32.~   "
182088|NCT01181427|"~     Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected~     subjects.~   "
182090|NCT01181401|"~     This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF~     induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by~     radio-antibody-therapy, in patients with unresectable LA-SCC of the HN region~     (oro-hypopharynx carcinoma, cancer of the oral cavity).~      The primary objective of the study is to assess the feasibility of an experimental~     'fractionated' TPF regimen compared to a current standard TPF regimen.~      Composite endpoint of compliance and feasibility in terms of~        -  response (RECIST1.1) and~        -  hematological acute toxicity (CTCAE v.4.02)~        -  on time application of RAT following an experimental or standard TPF IC.~      Secondary endpoints are~        -  Treatment intensity achieved~        -  Toxicity (according to CTCAE v.4.02)~        -  Response rates after completion of induction chemotherapy and after completion of entire~          protocol treatment (RECIST1.1)~        -  Survival (progression-free, metastasis-free, recurrence-free, overall) 1 year after~          randomisation~        -  Quality of life according to EORTC QoL C30 & HN35~      The study will be conducted at 5-6 investigational sites in Germany recruiting 90 patients in~     total. Eligible patients will have a diagnosis of histologically confirmed SSC of the HN.~     Patients will receive one of 2 different regimens of TPF IC followed by cetuximab together~     with radiotherapy (RAT) or a standard radiochemotherapy(RCT) regimen.~   "
182091|NCT01181388|"~     Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce~     bleeding complications in AMI patients.~   "
182092|NCT01181375|"~     The experiments outlined in this proposal will compare a number of currently available~     techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix~     cancer. The aim of these experiments is to establish the relationship of the clinically~     relevant outcome measures of tumour control and survival following radiation therapy with~     these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia. These~     characteristics will be assessed in patients undergoing treatment using techniques which have~     reached an appropriate level of development for clinical evaluation and aim to determine the~     best technique for determining these parameters of the tumour microenvironment. A number of~     novel strategies directed at the microenvironment are undergoing or soon will be undergoing~     clinical evaluation and selection of appropriate patients for these trials is of great~     importance.~   "
182093|NCT01181362|"~     Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes~     defined on this volumetric information data set. However, target delineation also depends on~     disease seen endoscopically which may not be visible on CT. We are developing imaging and~     tracking technology to improve target delineation in Radiation Therapy (RT) planning for head~     & neck cancer using quantitative registration of 2D endoscopic information with CT data.~     Diagnostic endoscopy is performed in the upright position. CT images and radiation delivery~     are obtained with the patient in the supine position. The accuracy of the registration will~     be improved if performed in the same position to prevent mobile soft tissue structures~     shifting between the upright and supine positions. Since therapy must be performed in the~     supine position, we intend to check the feasibility of performing endoscopy in the supine~     treatment position. We will compare and assess patient comfort and endoscopic sightlines~     during an endoscopy procedure in both the upright and supine positions.~   "
182094|NCT01181349|"~     This is a multicenter, observational study in adult participants undergoing different types~     of elective surgical procedures requiring general anesthesia. During the first study period,~     there will be a cross-sectional evaluation of neuromuscular blockade level upon participant~     arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital~     discharge data from the participants will be collected. The purpose of this study is to~     determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at~     PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.~   "
182095|NCT01181336|"~     The purpose of this study is to see whether a single vaccination (injection) with the~     investigational influenza vaccine is safe in healthy subjects. The study is also designed to~     evaluate four different dose formulations of the vaccine to see which gives the best immune~     response.~   "
182096|NCT01181323|"~     The purpose of this research study is to learn more about the safety of 2 licensed flu~     vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women~     who are breastfeeding and to compare the immune response (body's defense against foreign~     substances) of breastfeeding mothers, who receive intranasal flu vaccine, with breastfeeding~     mothers receiving the flu vaccine shot. Healthy women (240 volunteers, 28-120 days post~     delivery) who plan to breastfeed through 28 days post vaccination and who have not received~     influenza vaccine for the influenza season for which they are being enrolled, will be~     assigned by chance to 1 of the 2 vaccines in the following manner: flu vaccine nasal spray~     and a placebo (inactive substance) shot or a flu vaccine shot and a placebo nasal spray.~     Study procedures include: nasal swabs, blood samples, and completion of memory aids.~     Participants will be involved in this United States based study for about 6 months.~   "
182097|NCT01181310|"~     The drug, scopolamine, can result in short-term impairments of cognitive function, attention,~     and memory that resemble those seen in aging and Alzheimer's disease. This study tested the~     capability of both individual and combined doses of MK-3134 and the current standard~     treatment: donepezil (Aricept), to reverse such impairments, following a single dose of~     scopolamine. Participants were evaluated after each of 5 different treatment periods (in a~     cross-over, double-dummy design): A: placebo to match both donepezil (oral [PO]) and MK-3134~     (PO) followed by placebo scopolamine (subcutaneous [SQ]); B: placebo to match both donepezil~     (PO) and MK-3134 (PO), followed by scopolamine SQ; C: MK-3134 (PO) followed by scopolamine~     SQ; D: donepezil (PO) followed by scopolamine SQ; E: MK-3134 (PO) and donepezil (PO) followed~     by scopolamine SQ. The doses of MK3134, donepezil, and scopolamine were the same over all~     treatment arms in which the specified drug was administered. There were 8 total visits for~     each treatment period, including 5 Treatment Visits requiring 14-day intervals between visits~     for study-drug washout. Participants were assessed for cognitive function before and after~     each treatment period during the Treatment Visits.~   "
182098|NCT01181297|"~     The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed~     formula with an added probiotic in children with documented milk allergy.~   "
189321|NCT01086423|"~     The purpose of the study is to evaluate the immunogenicity and reactogenicity of~     Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4~     and 5 months of age.~   "
182099|NCT01181284|"~     Patients with pulmonary arterial hypertension(PAH) suffer from chronic shortness of breath,~     and have impaired survival related to progressive right ventricular failure. Abnormal~     vasoreactivity to nitric oxide(NO) plays a role in the pathophysiology of PAH.~     Phosphodiesterase Type 5 Inhibitor (PDE5 inhibitors) sildenafil have been shown to be~     beneficial in PAH, but extent of benefit is variable.~   "
182100|NCT01181271|"~     Relapse remains a principle cause of treatment failure for patients with aggressive lymphoma~     after autologous transplantation. Non-myeloablative allogeneic transplantation allows~     patients to receive an infusion of donor cells in an attempt to induce a graft versus~     lymphoma effect. This study will assess the feasibility, safety and efficacy of the~     combination of autologous stem cell transplantation followed by non-myeloablative~     transplantation for patients with poor-risk aggressive lymphoma.~   "
182101|NCT01181258|"~     In this study the investigators investigate a cell therapy strategy that could harness~     allogeneic effectors that can potentially mediate anti-lymphoma effect. The investigators~     have designed a novel lymphodepleting conditioning regimen followed by infusion of~     donor-derived natural killer (NK) cells and interleukin-2 (IL-2) for patients with refractory~     lymphoid malignancies.~   "
182102|NCT01181245|"~     Objectives~        -  Primary: To evaluate the safety and tolerability of FG-3019 in combination with~          gemcitabine and erlotinib~        -  Secondary: To evaluate the efficacy and pharmacokinetics of FG-3019 in combination with~          gemcitabine and erlotinib~   "
182103|NCT01181232|"~     The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified~     release) compared to zolpidem IR (immediate release) in patients with primary insomnia.~   "
182104|NCT01181219|"~     Transepithelial CXL (performed without epithelial removal) seem to have similar clinical~     effect on keratoconic eyes compared to the standard CXL (which includes epithelial removal).~     The current study attempts to prove that hypothesis.~      A prospective, controlled, randomized, contralateral trial, will involve one eye of the~     patient to be treated with transepithelial CXL, while the control eye will be treated with~     the standard CXL. Totally 20 patients (age >18 and <40 years) referred by an ophthalmologist~     to the eye department of the University Hospital North Norway for CXL treatment of bilateral~     progressive keratoconus, will be recruited.~   "
182105|NCT01181206|"~     BaFo is a prospective, double-blinded randomized controlled clinical trial that assesses the~     numbers of surgical site infections in two different techniques of covering the abdominal~     wall in laparotomies. Standard covering with woven swabs is compared to a novel, approved 3M™~     Steri-Drape™ Wound Edge Protector.~   "
182106|NCT01181193|"~     This is non-randomized phase 2 study to assess efficacy and toxicity of long term high dose~     vitamin D3 given concurrently with chemo-radiotherapy (CCRT) containing temozolomide followed~     by adjuvant chemotherapy (ACT) with temozolomide in patients with newly diagnosed~     glioblastoma multiforme GBM). Preoperative diagnosis of GBM will be based on magnetic~     resonance imaging (MRI) brain scan. All patient will underwent craniotomy with partial or~     total resection of a visible tumour mass. All patients will be planned for postoperative~     three-dimensional conformal RT (3-DCRT) or intensity-modulated RT (IMRT) to residual tumour~     and/or resection bed. A total RT dose of 54-60 Gy will be delivered using 2 Gy daily~     fractions given over 5 days a week. Daily chemotherapy with temozolomide in the dose of 75~     mg/m2/day will be started at the first day of RT, and will be continued for entire period of~     RT inclusive week-end breaks. ACT will contain 6 cycles of oral temozolomide 150-200~     mg/m2/day given for 5 days every 4 weeks. Oral vitamin D3 will be administered in daily dose~     of 4000 IU. Vitamin D3 therapy will be started 1 week prior to commencing CCRT, and will be~     terminated immediately after completing last cycle of ACT. MRI scan of the brain will be~     performed at 4 months after completing CCRT, and than will be repeated every 4 months for~     first 2 years, and every 6 months for subsequent years. The study participants will be~     followed until disease progression or death. The study is expected to complete within 4~     years.~   "
182107|NCT01181180|"~     Experimental design overview The proposed project is a prospective experimental RCT study~     design. Independent old adults(age 65 years old and older) who do not suffer from balance~     problems willing to participate in the study will be tested before and after water~     consumption to explore whether there are differences in balance control as a result of~     dehydration.~   "
182108|NCT01181167|"~     The objective of this study is to assess the efficacy and safety of DU-176b compared with~     enoxaparin sodium for the prevention of venous thromboembolism in patients after elective~     total hip arthroplasty.~   "
182109|NCT01181154|"~     The hypothesis based on retrospective data is that, the rate of overall response-rate (PR +~     CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm~     (20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over~     a 3 year period (amendment n°3 - 11/12/2012).~   "
182110|NCT01181141|"~     The objective of this study is to evaluate the safety and efficacy of DU-176b compared with~     enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip~     fracture surgery.~   "
182111|NCT01181128|"~     The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc~     administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical~     treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm~     1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical~     treatment regimen. The secondary objectives of this study are: to characterize the PK profile~     of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to~     characterize the range of dose and schedules required to adequately prevent bleeding in a~     prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes~     in an on-demand, weekly treatment, or prophylaxis setting.~   "
182112|NCT01181115|"~     The study is designed to determine the effect of weekly intramuscular (IM) administration of~     30 mcg Avonex (interferon beta 1a) on safety parameters and gadolinium (Gd) enhanced and~     T2-weighted cranial magnetic resonance imaging (MRI) lesions in Chinese patients with~     clinically diagnosed (using revised McDonald criteria) relapsing multiple sclerosis (MS).~   "
182113|NCT01181102|"~     The objective of this study is to assess the efficacy and safety of DU-176b compared with~     enoxaparin sodium for the prevention of venous thromboembolism in patients after elective~     total knee arthroplasty.~   "
182115|NCT01181076|"~     Aim~      Allogeneic stem cell transplantation (allo-SCT) combined with several cycles of intensive~     chemotherapy is the only curative treatment for several malignant blood diseases. Most~     allo-SCT patients who are treated with intensive chemotherapy often have reduced nutritional~     status. Several studies have evaluated the effect of different nutrition intervention for~     allo-SCT patients, but there have not been found evidence-based recommendations for energy~     requirements, use of enteral nutrition (EN) and/or parenteral nutrition (PN). We are not~     aware of studies using QoL as end-point among allo-SCT patients allocated to specific~     nutrition intervention.~      Main hypothesis:~      Patients who receive individualized nutrition have better global QoL assessed with the~     European Organisation for Research and Treatment in Cancer (EORTC) QLQ-HDC29 tool three~     months after SCT~      Sub-hypotheses:~      Patients who receive individualized nutrition have:~      i) less often oral mucositis grade 3-4. ii) better nutrition status iii) decreased length of~     hospital stay, less episodes with fever, earlier engraftment and less often acute graft~     versus host disease (GVHD) grade 3-4, and iv) better main QoL scores on the scale for~     physical and social functions, fatigue, loss of appetite, nausea/vomiting and diarrhoea three~     months after allogeneic SCT, compared to the control group.~      Patients and methods A minimum sample of 100 patients will be included in the study. The~     patients enrolled in the study will be randomly assigned to the intervention- or control~     group. The patients in the intervention group will receive a therapeutic diet in combination~     with tube feeding with an additional PN if the estimated requirements by the enteral route is~     lower than reference values. The patients in the control group will receive nutrition support~     after established routine, first by the oral route, later by the PN route.~   "
182116|NCT01181063|"~     Due to the complexity of orally inhaled products (combination of a formulation and a~     device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo~     correlation(IVIVC) for inhaled dosage forms is not generally known.~      The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH~     product variants under development and compare pulmonary deposition (administration with~     charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.~   "
182117|NCT01181050|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy~     of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis~     (RA).~   "
182118|NCT01181037|"~     A retrospective study to compare clinical results of patients that were treated by Bipolar~     H.A. vs. closed reduction and internal fixation with Trochanteric Antegrade Nail for~     displaced femoral subcapital fracture.~   "
182119|NCT01181024|"~     This randomized, double-blind, placebo controlled, 3 part study will assess the safety,~     tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with~     chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized~     to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will~     receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period~     of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with~     chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.~   "
182120|NCT01181011|"~     To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose~     combination after single dose in healthy Chinese subjects.~      To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine,~     following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and~     in combination, in healthy Chinese subjects.~      To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy~     Chinese subjects.~   "
182121|NCT01180998|"~     The purpose of this study is to evaluate the clinical performance, defined as successful fit,~     of two toric contact lenses (one daily disposable and the other daily wear reusable contact~     lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens~     drop-outs, and non-users of toric contact lenses (neophytes).~   "
182122|NCT01180985|"~     The purpose of this study is to compare visual acuity and redness of eyes between a prototype~     contact lens and an already marketed contact lens.~   "
182123|NCT01180972|"~     This is a pilot community-based research study to examine the effects of specific~     environmental and social factors on physical activity, fitness, and health of middle school~     Hispanic children living in an inner-city community.~   "
182124|NCT01180959|"~     The goal of this clinical research study is to learn if the combination of AvastinTM~     (bevacizumab) and Tarceva (erlotinib hydrochloride) can help to control advanced liver~     cancer. The safety of this drug combination will also be studied.~   "
182125|NCT01180946|"~     Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate~     and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are in~     adolescent girls and how these levels vary with other hormonal measurements. We will also be~     looking at whether vitamin D supplementation in adolescents who are deficient in vitamin D~     alters the levels of FGF23 and other factors including insulin resistance.~   "
182126|NCT01180933|"~     Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid,~     both or a placebo during the second half of pregnancy. Biochemical measures are determined in~     maternal blood during pregnancy and in cord blood.~      Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years~     focus on long term effects of supplementation anthropometric development, neurological~     development and allergy risk.~   "
182127|NCT01180920|"~     The goal of this study is to determine the clinical importance of Periostin in oral health~     and disease. The long-term goal will be to develop practical applications for the diagnosis,~     treatment, prevention and cure of human periodontal diseases.~   "
182128|NCT01180907|"~     The purpose of the study is to determine whether positron emission tomography using the new~     imaging agent 18F-FAC can be used for imaging cancer and/or inflammation.~   "
182129|NCT01180894|"~     The purpose of this clinical trial is to determine whether intravenous iron supplementation~     of anemic, critically ill trauma patients improves anemia and reduces the need for a red~     blood cell transfusion.~   "
182130|NCT01180881|"~     The aim of this study is to follow up with all of the pediatric brain tumor patients who~     received proton beam radiation therapy at Massachusetts General Hospital (MGH) for which~     there is baseline neuropsychological testing in order to measure changes, if any, in~     neurobehavioral functioning (executive skills, emotional/behavioral functioning, and adaptive~     abilities) and their use of special education services at one year or more post-treatment.~     The investigators will also correlate neurobehavioral data with pertinent clinical~     information. Participation will be maximized through the use of mail-in, parental- and~     self-report questionnaires.~   "
182131|NCT01180868|"~     The purpose of this study is to determine the biodistribution of a new agent 1-L-(2~     deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate~     whether it can be used to image cancer, autoimmune disease, and inflammation~   "
182133|NCT01180842|"~     The investigators research question is whether or not yoga effectively alleviates symptoms of~     pain, sleep disturbance, anxiety and depression in children with cystic fibrosis. If yoga~     does prove to be effective, the investigators will educate our CF population about the~     benefits they may experience if they choose to incorporate yoga into their CF therapy. The~     investigators will also go on to do further research of other complementary alternative~     medicine therapies.~      This is a pre/post-test study with 20 subjects. The subjects will serve as their own~     controls. Each subject will participate in six yoga sessions over a ten week period.~     Subjects' symptoms will be evaluated with the use of questionnaires. The investigators will~     also test cortisol levels on weeks -2, -1, 1, 6, 7, 8. Cortisol is a hormone that is affected~     by stress. Testing of cortisol throughout the study will help us determine the subjects'~     stress level throughout the study.~   "
182134|NCT01180829|"~     This study will provide a pilot test of two different text message interventions for problem~     drinkers. Participants will be recruited using a general population telephone survey.~     Participants in a control group (who will not receive text messages) will be compared to~     participants who receive one of two different types of text message packages (12 text~     messages sent once per week in each) - a series of personalized feedback text messages or a~     series of consciousness raising test messages (i.e., messages that keep the thought of~     cutting down on their drinking in the participants' mind). Participants in the three~     different conditions will be followed-up in three months time to assess changes in drinking.~     It is predicted that participants who receive either of the text message packages will report~     reduced drinking as compared to those participants in the control condition who do not~     receive any text messages.~   "
182135|NCT01180816|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic~     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of~     tumors also exhibits the most aggressive behavior, resulting in median overall survival~     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy has consisted of~     surgical resection, external beam radiation or both. More recently, a Phase 3 clinical~     published by Stupp et al in 2005 showed a benefit for using radiotherapy plus concomitant and~     adjuvant Temozolomide. Still, all patients experience a recurrence after first-line therapy,~     so improvements in both first-line and salvage therapy are critical to enhancing~     quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV)~     therapies even cross the blood brain barrier (BBB). Superselective Intra-arterial Cerebral~     Infusion (SIACI) is a technique that can effectively increase the concentration of drug~     delivered to the brain while sparing the body of systemic side effects. One currently used~     drug called Temozolomide (Temodar) has been shown to be active in human brain tumors but its~     actual CNS penetration is unknown. This phase I clinical research trial will test the~     hypothesis that following the standard 42 day Temozolomide/radiotherapy regimen, Temozolomide~     can be safely used by direct intracranial superselective intra-arterial cerebral infusion~     (SIACI) up to a dose of 250mg/m2, followed by the standard maintenance cycle of temozolomide~     to ultimately enhance survival of patients with newly diagnosed GBM/AA. The investigators~     will determine the toxicity profile and maximum tolerated dose (MTD) of SIACI Temozolomide.~     The investigators expect that this project will provide important information regarding the~     utility of SIACI Temozolomide therapy for malignant gliomas, and may alter the way these~     drugs are delivered to our patients in the near future.~   "
182136|NCT01180803|"~     The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems~     using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using~     oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing~     exercise-induced hypoxemia in patients with COPD.~   "
182137|NCT01180790|"~     Evaluate safety, tolerability and antiviral response of ACH-0141625 compared to Standard of~     Care in HCV positive subjects.~   "
182138|NCT01180777|"~     The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of~     the printed etafilcon A with polyvinylpyrrolidone (PVP).~   "
182139|NCT01180764|"~     Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the good~     cholesterol) work better.~      Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and~     other lipoproteins, in patients with high triglyceride levels.~      Study funding: This study is being funded by an investigator-initiated research grant from~     Glaxo Smith Kline.~   "
182140|NCT01180751|"~     This clinical trial is being conducted to study the use of a radioactive glucose tracer as an~     imaging test [Positron Emission Tomography (PET)scan] in adults who have or are suspected of~     having cancer and in another group of adults to assess for neurologic conditions.~   "
182141|NCT01180738|"~     The purpose of this study is to compare two different walking training programs for persons~     with chronic stroke.~   "
182142|NCT01180725|"~     Background: Constipation is a common problem that affects nearly 60 million Americans. The~     treatment of constipation remains challenging with one half of patients dissatisfied with~     current therapy. There is a need for a food-based, natural, convenient and tasty alternative~     to the currently available OTC laxatives and fiber supplements, particularly for patients~     with occasional and mild constipation. Dried plums and prune juice have been traditionally~     used for the treatment of constipation but has not been systematically assessed in patients~     with well defined constipation. Also, the efficacy, palatability and tolerability of dried~     plums in the treatment of chronic constipation have not been examined.~      Aim: To investigate and compare the effects of dried plums and psyllium on the overall relief~     of constipation symptoms, taste and quality of life in adults with functional constipation in~     a randomized crossover controlled trial.~      Methods: We propose to study 40 subjects with functional constipation in a single blinded,~     randomized, cross-over study comparing 3 weeks of dried plums with 3 weeks of treatment with~     Psyllium~      Data analysis: The primary outcome measure will be the global relief of constipation symptoms~     as rated by the subject at the end of each phase of the study. Additionally, we will assess~     several secondary outcome measures that will include the number of Complete Spontaneous Bowel~     Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste~     on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient~     rating of constipation-related symptoms.~      Expected Results: We anticipate that treatment with dried plums will improve symptoms of~     constipation compared to the baseline. This improvement will be comparable to that achieved~     with psyllium (Metamucil) treatment. Additionally, dried plums will offer a natural, food~     based, convenient and more tasty alternative to over-the-counter laxatives and fiber~     supplements.~   "
182164|NCT01180439|"~     Non-invasive ventilation (NIV) in severe hypercapnic Chronic Obstructive Pulmonary Diseases~     (COPD) may be associated - during sleep - with recurrent episodes of patient ventilatory~     asynchrony, which in turn may affect quality of sleep, efficacy of ventilation and comfort of~     nocturnal NIV.Polysomnography (PSG) under NIV is necessary to detect these events.~      Adjusting ventilator settings according to respiratory events detected by PSG with NIV may~     improve quality of sleep, efficacy of ventilation and comfort of nocturnal NIV.~   "
182165|NCT01180426|"~     The purpose of this study is to evaluate the long-term efficacy and safety profile of~     tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.~   "
182166|NCT01180413|"~     The purpose of this study is to determine whether add-on of intensive vasodilator therapy can~     improve the coronary perfusion and reduce the total peripheral resistance in patients with~     ongoing treatment for essential hypertension.~   "
182143|NCT01180712|"~     Dietary strategies for alleviating the metabolic complications such as diabetes associated~     with obesity are actively being pursued as alternatives to pharmaceutical interventions The~     genus Vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a~     source of folk remedies for established diabetic symptoms, primarily as leaf or stem~     infusions or decoctions. Berries from this family such as blaeberry (BL) and blueberry (BB)~     are enriched in anthocyanins, polyphenolics recognized for their ability to provide and~     activate cellular antioxidant protection, inhibit inflammatory gene expression, and~     consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity.~     The association of obesity with adipose tissue stress, macrophage recruitment, and~     inflammatory gene expression suggests that eating edible berries from this genus might~     provide an effective alternative or supplementary intervention to attenuate obesity-~     associated inflammation and the associated insulin resistance.~      The aim of this study is to determine the effects of anthocyanin supplementation in the form~     of a concentrated blaeberry extract on insulin resistance and inflammation particularly in~     the adipose tissue following a three week supplementation period.~   "
182144|NCT01180699|"~     Influenza virus is an important cause of morbidity in the transplant population and can lead~     to viral and bacterial pneumonia and contribute to the development of rejection. Although the~     annual influenza vaccine is recommended for transplant patients, studies have shown that a~     single intramuscular dose has poor immunogenicity. There are no studies that define the~     effect of intradermal doses in this population. We plan to study the immunogenicity of two~     different administration routes of the influenza vaccine in 200 solid organ transplant~     patients during the 2010-2011 season. Patients will be randomized to receive influenza~     vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive~     the intradermal influenza vaccine will significantly reach a higher response to the vaccine.~     This study advances research on the prevention of serious viral infections in transplant~     recipients. Results from this study have the potential to directly improve patient care. If~     the use of the intradermal influenza vaccine is successful, this strategy may lead to a~     significant reduction in burden of disease, hospitalizations, and long-term morbidity.~   "
182145|NCT01180686|"~     The purposes of this study are to determine if there is a difference between two treatment~     methods of spine joints that are not moving as they should as determined by tenderness over~     the spine and activity of the muscles along side the spine with movement.~      The hypothesis is that there will be no difference between the two types of treatment.~   "
182146|NCT01180673|"~     This study will evaluate the effect of a senior center-based comprehensive therapeutic~     lifestyle intervention delivered through group-based counseling and motivational interviewing~     (MINT-TLC) among 250 hypertensive African American or Latino seniors age 60 and older in a~     randomized control trial.~   "
182147|NCT01180660|"~     Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve~     quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of~     intraoperative systemic lidocaine decrease postoperative opioid consumption and improve~     quality of recovery after laparoscopic gastric bypass surgery.~      This study has the potential to confirm an opioid sparing strategy for morbid obese patients~     undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea~     and the increased risk of postoperative hypoxemia make the development of opioid sparing~     techniques in this patient population warranted.~   "
182148|NCT01180647|"~     This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as~     self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release~     from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.~   "
182149|NCT01180634|"~     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory~     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which~     has been particularly problematic to eradicate and been implicated as the major cause of~     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung~     increases the local concentrations of antibiotic at the site of infection resulting in~     improved antimicrobial effects compared to systemic administration. Decreased efficacy,~     intolerance and high treatment burden with currently available therapies indicate a need for~     additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone~     levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies~     conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an~     antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal~     antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active~     against CF pathogens including those with high minimum inhibitory concentration (MIC) levels~     to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled~     MP-376 can be delivered rapidly and efficiently using a customized PARI investigational~     configuration of the eFlow® nebulizer system.~   "
182150|NCT01180621|"~     The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1~     pandemic of 2009. Many children either had the H1N1 infection or the adjuvanted H1N1 vaccine.~     Both H1N1 infection and adjuvanted vaccine produced strong immune responses which could last~     for some time.~      The seasonal influenza vaccine for this fall will be a trivalent inactivated product (regular~     seasonal influenza vaccine)once again, without adjuvant. It will contain 3 strains of killed,~     split-apart viruses that might circulate this winter, including the H1N1 pandemic strain. It~     is theoretically possible that giving the H1N1-containing seasonal vaccine to people who~     still have some immunity to H1N1 virus could result in more frequent side-effects. However,~     there is no good evidence that pre-existing immunity to a strain in the vaccine does increase~     side-effects. In short, there could be nothing out of the ordinary this fall but it would be~     prudent to check this before public flu vaccination programs begin.~   "
182151|NCT01180608|"~     Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain~     in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS):~      The aim of our study is to investigate the effect of Pregabalin as a treatment for~     neuropathic pain in a homogeneous study population, using proton MRS (1H MRS) focusing on~     four regions of interest (bilateral thalami, rostral anterior cingulated cortex (rACC) and~     dominant dorsolateral prefrontal cortex (DLPC).~   "
182152|NCT01180595|"~     Total knee replacement is an effective option for treating chronic knee conditions that cause~     pain and functional impairment. Significant improvements in quality of life, as measured by~     both disease specific and generic quality of life measures have been well documented.~     Carefully monitored introduction of new implant designs through small, randomized trials~     using radiostereometric analysis (RSA) is gaining support. RSA is a radiographic technique~     that uses small tantalum balls implanted into the patient's bone to measure micromotion (<1~     mm) at the bone - implant interface, something which is not possible to do reliably using~     regular x-ray techniques. The amount of micromotion that occurs within 2 years of surgery can~     be used to predict the long term survival of knee replacements. This provides a method for~     detecting inferior implant designs using only a small number of patients before release of~     these products into large clinical trials.~      The study purpose is to utilize RSA to compare the migration patterns of the Trabecular~     Metal(TM) Monoblock and the TM Modular Total Knee Arthroplasties during the first two postop~     years and to determine what proportion of cases achieve adequate fixation. Secondary outcome~     measures will be recorded to quantify changes in functional status of subjects after surgery~     and bone mineral density will be monitored to quantify any changes around the implant.~     Migration patterns will be compared to results obtained from previous studies of uncemented~     and cemented total knee arthroplasty components conducted at this centre.~      Null Hypothesis: There is no significant difference in micromotion patterns of the TM~     arthroplasty components of the monoblock design and the modular design.~      Alternative Hypothesis: There are significant differences in micromotion patterns between the~     tibial components of the monoblock design and the modular design.~      This is a consecutive sample randomized control trial of patients undergoing total knee~     arthroplasty with the TM Monoblock and TM Modular Knee Arthroplasty systems utilizing RSA to~     identify the migration patterns of the tibial components of the implant. DEXA scanning will~     also be conducted to determine changes in the bone mineral density adjacent to the implant.~     Health status and functional outcome measures will be recorded to quantify functional status~     of subjects before surgery and at each follow-up interval. Gait will be monitored and~     analyzed preoperatively and postoperatively throughout the duration of the trial.~   "
182153|NCT01180582|"~     The purpose of this study is twofold: 1) to use RSA to determine the migration patterns of~     the PA coated Triathlon Total Knee Arthroplasty components during the first 2 years~     postoperatively and thus determine the proportion of cases where adequate fixation is~     achieved, and 2) to use DEXA scanning to document peri-prosthetic bone mineral density~     changes in response to the PA coated Triathlon Total Knee arthroplasty over the first two~     postoperative years.~      In addition, gait assessment and validated outcome questionnaires will be utilized to~     quantify changes in functional status of subjects after surgery and migration patterns will~     be compared to results obtained from previous studies of uncemented total knee arthroplasty~     components conducted at this centre. Questions to be asked are: 1. Do the components achieve~     adequate fixation to the underlying bone? 2. What are the migration patterns (translations~     and rotations) of the PA coated arthroplasty components during the first two years~     postoperatively and are they different from that seen for other implants that have been~     studied with RSA at this institution? 3. For what proportion of implants does migration~     continue to increase during the two year follow-up? 4. Are inducible displacements, measured~     at weight-bearing follow-ups, consistent over time and do they indicate that adequate~     fixation has been achieved? 5. Are there changes over time in bone mineral density of~     peri-prosthetic bone in the PA coated Triathlon total knee arthroplasty? 6: Where do changes~     in bone mineral density occur? 7: Is there a significant difference in health status and~     functional outcome before and after total knee arthroplasty using PA coated Triathlon total~     knee arthroplasty components? 8: Are there changes in gait symmetry and centre of mass (COM)~     displacements as assessed with the Walkabout Portable Gait Monitor pre- and post-operatively~     and how does study gait data compare to asymptomatic gait? and finally, Question 9: Are there~     differences in the micromotion patterns between the when compared to other samples of knee~     implants in our RSA database?~   "
182154|NCT01180569|"~     The purpose of this study is to see if a treatment with Lenalidomide, which is a pill given~     by mouth for 7.5 months (30 weeks total), can delay the growth of lymphoma or shrink the~     lymphoma. Lenalidomide is a pill that has been approved by the Food and Drug Administration~     (FDA). It is used to treat some forms of cancer-like illnesses (myelodysplastic syndrome~     (MDS)and in combination with dexamethasone for patients with multiple myeloma (MM) who have~     received at least 1 prior therapy. MDS and MM are cancers of the blood). This drug works by~     stimulating the body's immune system and by reducing the blood supply to cancer cells. Cancer~     cells need blood to live and grow. In this study, the drug is considered a new or~     experimental drug because we are learning how it works against your form of lymphoma.~   "
182155|NCT01180556|"~     The purpose of this study is to assess the effect of probiotics in childhood recurrent~     abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4~     weeks with a follow up phase of additional 4 weeks.~   "
182156|NCT01180543|"~     The purpose of this study was to demonstrate the effect of short treatment with active OPLON~     patches on Acne.~   "
182157|NCT01180530|"~     This study is conducted in Asia, Europe and North America. The aim of this observational~     study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence~     of technical complaints related to adverse reactions). Study duration: 12-18 weeks.~   "
182158|NCT01180517|"~     The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon~     (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention~     (PCI) of Medina 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment~     with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.~   "
182159|NCT01180504|"~     The primary objective of this phase-II study is to assess the toxicity of consolidation~     intensity-modulated whole-abdominal radiotherapy using tomotherapy in patients with advanced~     optimally debulked stage International Federation of Gynecology and Obstetrics (FIGO) III~     ovarian cancer with a complete remission after adjuvant chemotherapy.~      36 patients will be treated to a total dose of 30 Gy in 1.5 Gy fractions. The planning~     target-volume includes the entire peritoneal cavity and the pelvic and para-aortal node~     regions. Intensity-modulated whole-abdominal radiotherapy allows an effective sparing of~     liver, kidneys and bone-marrow (vertebral bodies and pelvic bones).~   "
182160|NCT01180491|"~     The purpose of this study is to further evaluate and document early visible effects on nail~     appearance of topical K101.~   "
182161|NCT01180478|"~     The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band~     Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients~     with non-muscle invasive bladder cancer.~   "
182162|NCT01180465|"~     LIPO-102 is under evaluation for treatment of abdominal adiposity~   "
182163|NCT01180452|"~     Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma~     (SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with SBA~     in 20% of cases, always described in diseased sites. The progression to neoplasia and natural~     history remains unknown but progression of inflammation to dysplasia and then to~     adenocarcinoma is suspected.~      As for surveillance recommendations for colorectal carcinoma in long standing inflammatory~     colonic disease, endoscopic screening of SB could be proposed in CD patients with risk~     factors of SBA. No study can be found in literature.~      The investigators propose a multicenter exploratory open study on prospective cohort of CD~     patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia~     and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population~   "
182167|NCT01180400|"~     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like~     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken~     together with another antidepressant.~   "
189322|NCT01086410|"~     The purpose of this study is to assess the effect of six weeks' treatment with two once-daily~     strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system~   "
182168|NCT01180387|"~     The Reproductive Medicine Network (RMN) is a nationwide cooperative network of 7 clinical~     sites and a data coordination center, and is sponsored in 5 year increments by The Eunice~     Kennedy Shriver National Institute for Child Health and Human Development (NICHD). The RMN is~     charged with designing, implementing and publishing high quality clinical research in~     reproductive medicine. It has been in existence for over 15 years and has performed several~     seminal clinical trials that have fundamentally changed clinical practice in this field. In~     addition, many worthy ancillary protocols have been generated and published.~      It is this latter fact, as well as the continued interest by investigators both inside and~     outside the RMN for access to DNA or serum samples from the previously performed trials, that~     has motivated the present investigators to proactively begin a biologic samples repository~     from the ongoing and pending RMN clinical trials. Ideally, this repository would allow~     investigators to seamlessly access trial samples for many years into the future, and thus~     greatly amplify the use of resources and the impact of the RMN.~   "
182169|NCT01180374|"~     Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists~     of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the~     interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.~   "
182170|NCT01180361|"~     Hypothesis: SLE and RA increase risk of myocardial infarction (MI, heart attack). Immune~     reactants in the circulation of SLE patients downregulate cholesterol efflux proteins~     27-hydroxylase and ABCA1 and upregulate scavenger receptor CD36, thus encouraging cholesterol~     accumulation. Adenosine A2A receptor agonist or statin treatment of cells exposed to SLE~     plasma (or immune complexes or cytokine-enriched plasma fractions from SLE patients) may~     ameliorate inflammatory properties of their plasma, lessening its atherogenic potency.~      Rationale: SLE and RA plasma contain components not present in significant levels in normal~     plasma that could, individually or acting together, affect 27-hydroxylase, ABCA1 and CD36~     expression. Candidate components include autoantibodies, immune complexes, and various~     cytokines. Statins reduce major cardiovascular events and death. Modulation of adenosine~     signaling participates in regulation of 27-hydroxylase and ABCA1. As a potential preventative~     and therapeutic approach to atherosclerotic cardiovascular disease, the investigators~     evaluate the effect of A2A receptor agonists and statins on atherogenic parameters in SLE and~     RA plasma.~      Experimental Plan: Quantitate 27-hydroxylase and several other proteins involved in cellular~     cholesterol uptake and excretion in THP-1 monocytes/macrophages and HAEC after exposure to~     plasma and plasma components from SLE patients (and controls) ± lipid loading with acetylated~     LDL with/without addition of A2AR agonist, statin, or both. Determine relative impact of~     immune complexes and cytokines on expression of proteins involved in cholesterol flux.~     Determine levels of proteins involved in cellular cholesterol influx/efflux in peripheral~     blood mononuclear cells isolated from RA, SLE and psoriatic arthritis patients and normal~     controls at baseline, then following incubation in culture media alone or with statin,~     adenosine A2A agonist or both statin + A2AR agonist.~   "
182171|NCT01180348|"~     The dermatological treatment for reducing facial wrinkles with injectable drug Botulift~     (botulinum toxin type A - Laboratório Químico Farmacêutico BergamoLtd.) has a not inferior~     activity when compared with Botox ® (botulinum toxin - Allergan Inc.) in clinical trials.~   "
182172|NCT01180335|"~     This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven~     chemotherapy in patients with breast cancer.~   "
182173|NCT01180322|"~     This is a randomized phase II, four-arm, open-label, multi-center study in adult patients~     with acute myeloid leukemia (AML) as defined in inclusion/exclusion criteria.~      The primary efficacy objective is to evaluate the impact of sequential or concurrent addition~     of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on the~     complete remission (CR) rate~      Sample size: 336 patients~      The treatment duration of an individual patient randomized into one of the three experimental~     arms (Arm B, C, D) (in case of application of induction, consolidation and maintenance~     therapy with Azacitidine) is about 30 months.~      The treatment duration for patients randomized into the standard arm of the study (Arm A) is~     about 7 months (in case of application of induction, consolidation and 2-yrs observation as~     maintenance (without treatment with Azacitidine)).~      In case of induction followed by consolidation with allogeneic Stem cell transplantation~     (SCT) the treatment duration per patient is about 6 months.~      Every patient will be followed until month 54 after inclusion into the study. Duration of the~     study for an individual patient including treatment (induction, consolidation [chemotherapy~     or allogeneic SCT], maintenance [experimental arm with Azacitidine or observation]) and~     follow-up period: 54 months~   "
182174|NCT01180309|"~     Purpose To investigate the relationship between lingual frenum and possible alterations in~     the articulation of phonemes.~      Methods This is a quantitative observational study, the individual operative kind with~     transversal time reference. The population sample consisted of 16 individuals, each one with~     their phonological system complete. The data were captured through an application form that~     contained relevant aspects as to the qualitative-classification of the lingual frenum,~     quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue~     mobility and ERT - 78 phonologically balanced words.~   "
182175|NCT01180296|"~     To evaluate whether daily oral micronized progesterone is effective in preventing recurrent~     spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal~     serum progesterone levels.~   "
182176|NCT01180283|"~     Sixty diabetes men with erectile dysfunction from mild to severe who agree to participate is~     going to have medical care approximately for 16 weeks.~      During the first 4 weeks, patients will not receive any inhibitor of phosphodiesterase 5. In~     the following eight weeks, patients will receive oral lodenafil carbonate. They will complete~     the International Index of Erectile Dysfunction (IIEF) questionnaire in the site and answer~     the Sexual Encounter Profile (SEP) questions 2 and 3 and the Erection Hadness Score (EHS)~     after each intercourse or attempt without or using oral lodenafil cardonate 80mg.~      Questionnaire of adverse event is included in patient diary.~   "
182177|NCT01180270|"~     The purpose of this experimental pilot study is to test the effect of normalization of the~     head position on the sense of balance at patients with cervical dystonia under routine~     botulinum toxin treatment.~   "
182178|NCT01180244|"~     The purpose of this study is to determine whether persons treated with a low-intensity,~     noninvasive form of cortical electrical stimulation experience a reduction in symptoms of~     fibromyalgia different than persons receiving a sham treatment. Outcome measures include~     reduction in patient pain levels and improvement in sleep measures.~   "
182190|NCT01180088|"~     The aim of this study was to evaluated the advantages of routine application of the anterior~     approach in patients scheduled to right hepatectomy or extended right hepatectomy, without~     infiltration of segment 1, inferior vena cava or main bile duct.~   "
189727|NCT01081106|"~     The purpose of this study is to see whether low level laser therapy can help maintain normal~     hair growth on the scalp in people receiving chemotherapy, which is generally associated with~     hair loss.~   "
182179|NCT01180231|"~     The prevalence of obesity is increasing rapidly among adults and has more than doubled in the~     past 10 years. The metabolic syndrome (MS) is often associated with obesity. It is~     characterized by abdominal obesity, high blood pressure, unfavorable blood cholesterol~     profile, elevated blood sugar and impaired insulin action. Persons with the MS have an~     increased risk of developing type 2 diabetes as well as heart and kidney disease.~      The prevalence of obesity and MS is also very high in children and young adults. While there~     are increasing numbers of studies assessing risk factors for cardiovascular and kidney~     disease in middle aged to older obese subjects, few studies have addressed the issue of the~     presence of obesity in young adults and its association with MS on early damage to the organs~     such as the kidneys, the heart and the blood vessels. The investigators' laboratory has a~     particular interest on the sympathetic nervous system, which is an important regulatory~     mechanism of both metabolic and cardiovascular function, as altered sympathetic activity may~     play a role in the complications of obesity.~      Moxonidine is a medication that is approved in Australia by the Therapeutic Goods~     Administration to treat high blood pressure. It works by decreasing the activity of the~     sympathetic nervous system. With the elevation of the sympathetic activity in obesity, the~     investigators believe moxonidine may have a favourable role in rescuing early organ damage~     associated with obesity. This study will assess whether treating obese subjects with~     moxonidine have positive effects on blood vessels, cardiac and kidney function and anxiety~     disorder. The investigators will also examine the influence of the sympathetic nervous system~     activity in these possible altered cardiac, kidney and vessel functions.~   "
182180|NCT01180218|"~     To investigate the clinical outcomes of acute myocardial infarction (AMI) patients with~     multivessel disease undergoing percutaneous coronary intervention (PCI) either in~     infarct-related artery only or in multivessel in Drug eluting stents (DES) era, using the~     everolimus-eluting stent (Promus™ Element™ Stent, Boston Scientific) in real-world clinical~     practice.~   "
182181|NCT01180205|"~     To show superior effects of the combination Telmisartan and Amlodipine (T and A) vs~     Olmesartan and Hydrochlorothiazide (O and HCTZ) on endothelial dysfunction as measured by~     flow mediated dilation (FMD) in hypertensive at risk patients beyond bloodpressure BP (equal~     BP in both arms; target BP <140/90 mmHg (<130/80 mmHg for renally impaired and/ or diabetic~     patients). To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness~     and carotid atherosclerotic plaques.~   "
182182|NCT01180192|"~     In the aetiology of postpartum uterine atony, hypoxia is considered an important factor~     although some suggest that peripheral oxygen saturation is not influenced by oxygen~     inhalation in women during the first and second stages of labor. Enhancing oxygen delivery to~     myometrium through additional inhaled oxygen may improve uterine contractions. Therefore, it~     is reasonable to consider that oxygen inhalation may promote myometrial contraction and~     prevent postpartum haemorrhage (PPH) due to uterine atony. The tendency for the uterus to~     relax in women encountering respiratory problems immediately after cesarean section under~     general anaesthesia further strengthened this theory.~      The aim of this study was to evaluate the effectiveness of oxygen inhalation immediately~     after vaginal delivery on blood loss. The investigators hypothesized that inhaled oxygen~     helps to maintain uterine retraction during immediate postpartum period and hence reduces~     vaginal blood loss.~   "
182183|NCT01180179|"~     The aim of this study is to compare the efficacy of a proton pump inhibitor (lansoprazole)~     and a histamine-2 receptor antagonist (famotidine) in preventing recurrent ulcer bleeding in~     patients with a history of H. pylori-negative idiopathic peptic ulcers.~   "
182184|NCT01180166|"~     The prognosis of patients with inoperable locally advanced or residual/relapsed gastric~     cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended.~     Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown~     its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of~     these treatment need to be further analyzed.~   "
182185|NCT01180153|"~     To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with~     unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma.~   "
182186|NCT01180140|"~     The purpose of this study is to determinate the utility of staple-line reinforcement on~     lineal gastrointestinal anastomoses.~      Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive~     lineal stapled anastomoses.~   "
182187|NCT01180127|"~     This is a randomized controlled trial to test the impact of a flavonol containing food~     product and aerobic exercise on cognitive function and brain structure.~   "
182188|NCT01180114|"~     The overall goal of SUUBI-MAKA is to further develop and preliminarily examine a family~     economic empowerment intervention that creates economic opportunities (specifically Children~     Development Accounts) for families in Uganda who are caring for children orphaned due to the~     AIDS pandemic, and to lay groundwork for a bigger study with practice and policy implications~     for Sub-Saharan Africa.~   "
182189|NCT01180101|"~     Obesity is an established risk factor for development and progression of kidney disease.~     Intentional weight loss in people without kidney disease results in an improvement in~     diabetes, blood pressure, cholesterol, cardiovascular disease and overall death rates. The~     investigators do not know whether this holds true in patients with chronic kidney disease. In~     the proposed pilot study, the investigators will analyze if kidney function stabilizes after~     weight loss interventions in obese kidney disease patients and the mechanisms that might~     mediate this beneficial effect. If weight loss in kidney disease patients results in~     stabilization of kidney function, this would provide an opportunity to conduct a long-term~     prospective study to analyze the sustained benefits of weight loss in kidney disease~     patients.~      Specific aim 1:~      To ascertain the effects of lifestyle modification or bariatric surgery on urinary protein~     excretion and renal function among obese CKD patients.~      Hypothesis: Weight loss attained through either lifestyle modification or surgical~     intervention will result in lowering of urinary protein excretion and stabilization of renal~     function among obese CKD patients.~      Specific aim 2:~      To identify the mechanism that mediates the change in urinary protein excretion and renal~     function among obese CKD patients undergoing lifestyle modification or bariatric surgery.~      Hypothesis: Weight loss attained through either lifestyle modification or surgical~     intervention will result in amelioration of endothelial dysfunction, inflammation, insulin~     resistance and an increase in High Molecular Weight (HMW) adiponectin levels that then~     mediate the improvement in urinary protein excretion and renal function among obese CKD~     patients.~   "
182191|NCT01180075|"~     Purpose: To see how growing older changes the amount of HIV drugs in the blood of~     HIV-infected men and women. Many changes happen in the body as it ages that may affect the~     way drugs are carried in the blood, broken down or removed from the body. This study will~     look at the amount of drug in the blood and cells of the immune system for patients taking~     efavirenz, tenofovir and emtricitabine or atazanavir boosted with ritonavir, tenofovir and~     emtricitabine.~      Participants: The population will comprise of 56 (6 for intensive PK and 50 for sparse~     sampling) HIV-infected adults currently adhering to an antiretroviral regimen containing~     efavirenz with tenofovir and emtricitabine and the same number and distribution of~     HIV-infected adults currently adhering to an antiretroviral regimen containing atazanavir~     boosted with ritonavir with tenofovir and emtricitabine.~      Procedures (methods): This study will be completed at the University of North Carolina at~     Chapel Hill. There will be four groups of subjects: Efavirenz/tenofovir/emtricitabine Group~     A, Efavirenz/tenofovir/emtricitabine Group B, Atazanavir/ritonavir/tenofovir/emtricitabine~     Group A, and Atazanavir/ritonavir/tenofovir/emtricitabine Group B.~      The initial six subjects (Group A) for intensive PK analysis for each regimen will be~     recruited from the the UNC ID Clinic or the Moses Cone Health System Infectious Diseases~     Clinic, and will be comprised of non-frail subjects not currently receiving interacting~     drugs. If subjects provide informed consent, timed blood samples will be obtained to~     determine pharmacokinetic parameters around an observed dose of one of the two study~     regimens. A whole blood sample will also be collected and stored for potential drug~     metabolizing enzymes and transporters genotyping in the future. Group A subjects will~     complete a follow-up visit after their sampling visit.~      50 subsequent subjects (Group B) for each regimen will be screened simultaneously, with no~     more than 10 subjects enrolled for each regimen in Group B prior to the completion and~     analysis of Group A. These subjects will also be recruited from either site. Group B subjects~     will have one or two sampling visits with 1 to 4 blood samples obtained at each visit, with a~     stored sample for future genotyping obtained on one of the visits. Samples will be collected~     just prior to a dose, at 2 hours, between 4 and 6 hrs, and between 10 and 14 hours after a~     medication dose. These visits may coincide with the subjects' regularly scheduled visit to~     the clinic, or be scheduled separately, depending on the preference and availability of the~     subject.~   "
182192|NCT01180062|"~     This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which~     will be conducted at one study site. This study will include 3 cohorts. Each cohort will have~     approximately 5 subjects. Subjects will not be randomized into the study. The first cohort~     will receive low dose drug insert, second cohort will receive 2 low dose drug inserts thus~     achieving twice the drug levels compared to cohort I and third cohort will receive high dose~     drug insert.~   "
182193|NCT01180049|"~     This study will compare the effectiveness and safety of two different doses of temsirolimus~     (Torisel).~   "
182194|NCT01180036|"~     The primary outcome of this study is to determine whether or not the B cell targeting with~     Rituximab is more effective than Cyclosporine in inducing long term remission of proteinuria.~   "
182195|NCT01180023|"~     Sweeping or stripping of the membranes (in this paper referred to as membrane sweeping) is~     a widely utilized technique to hasten delivery for women at 37+ weeks gestation. The process~     of membrane sweeping probably causes release of prostaglandins from the decidua and the~     cervix. The efficacy of membrane sweeping is well studied, and has been shown to increase the~     number of patients in labor within 72 hours, reduce the frequency of pregnancy continuing~     beyond 41 or 42 weeks, and reduce the frequency of formal induction of labor. Thus, it is a~     safe and practical option for women who wish to avoid inductions of labor or postterm~     pregnancies.~      Group B streptococcus (GBS; streptococcus agalactiae) is a gram positive coccus that~     frequently colonizes the human genital tract. In pregnant women, GBS can cause urinary tract~     infections, chorioamnionitis, and postpartum endometritis. Newborn infants can also acquire~     GBS infection during passage through the vagina. Early onset GBS disease in the newborn can~     lead to pneumonia, meningitis, and sepsis, all of which can be life-threatening. Early onset~     GBS disease has become rare since the widespread use of GBS screening and prophylactic~     treatment of pregnant women.~      The relationship between early onset GBS disease and sweeping of the membranes is not known.~     Based on the theoretical increased risk of bacterial seeding after membrane sweeping, as well~     as concern for fast labors and inadequate treatment after membrane sweeping, some~     practitioners choose not to sweep membranes in GBS positive patients. A meta-analysis did not~     show a difference in neonatal or maternal infection rates between women who underwent~     membrane sweeping and those who did not. ACOG guidelines state the risks of membrane~     stripping in GBS positive patients has not been investigated in well-designed, prospective~     studies. Therefore, data are insufficient to encourage or discourage this practice.~      Specific Aims:~      In order to help elucidate the effect of membrane sweeping in GBS positive patients, the~     investigators propose this prospective randomized trial. The investigators primary objective~     is to determine whether membrane sweeping in GBS positive women is associated with inadequate~     antibiotic treatment in labor (defined as less than four hours of antibiotic therapy prior to~     delivery). The investigators secondary objectives are to measure the effect of membrane~     sweeping on pregnancy duration, length of labor and adverse events potentially related to~     membrane sweeping such as maternal chorioamnionitis and neonatal morbidity. Randomization is~     the real research portion of this study, since offering membrane sweeping is already the~     standard of care. Patients are followed until the time of delivery, which is within 6 weeks~     of enrollment for most women.~   "
182196|NCT01180010|"~     This research study is being done because patients with a history of chest radiation~     treatment for Hodgkin's disease have been shown to be at increased risk for developing lung~     cancer a number of years out from treatment. The risk appears to be further increased among~     patients with a smoking history. In this study, the CT scans will be read and interpreted by~     the study radiologist, and the results recorded in a consistent manner. Depending on the~     findings of the initial CT scan, we will then either repeat the scan in 1 year, or if~     indicated, send you for further scans or a biopsy. The information collected in this study~     will help researchers and clinicians in providing more concrete recommendations and screening~     guidelines for future survivors of Hodgkin's disease who have had similar exposures to~     radiation and/or chemotherapy and smoking.~   "
182197|NCT01179997|"~     The aim of this study was to compare the response to cardiac resynchronization therapy when~     the interventricular pacing interval was optimized by Tissue Doppler Imaging (TDI) to~     response when it was optimized following QRS width criteria.~   "
182198|NCT01179984|"~     The purpose of this study is to evaluate the effectiveness and safety of a new delivery~     system for the Bard® LifeStent® Vascular Stent System.~   "
182199|NCT01179971|"~     Purpose: To investigate into the differential effects of polyunsaturated fatty acids as~     compared to standard control therapy (olive oil) on disease activity and biochemical~     parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA).~   "
182200|NCT01179958|"~     The purpose of this study is to test the hypothesis that aerobic exercise leads improved~     cognitive function accompanied by increases in gray matter density and changes in functional~     magnetic resonance imaging (fMRI) patterns of task-related activation.~   "
182201|NCT01179945|"~     The investigators propose to examine the effects of the common food preservative sodium~     benzoate on blood glucose and related hormones and metabolites. If an effect is demonstrated,~     patients with increased diabetes risk could be counseled to avoid this preservative.~   "
182202|NCT01179932|"~     Primary Objective: Conduct a prospective, observational pilot study that assesses the~     frequency and severity of anesthesia charting fidelity weaknesses in three separate clinical~     environments (Cardiac surgical operating room, cardiac surgical intensive care unit, and~     electrophysiology laboratory) as assessed by a customized error scoring system that focuses~     on the magnitude of errors among multiple continuous, categorical and dichotomous variables.~     The errors are being assessed in order to identify the most common charting inaccuracies so~     that target areas appropriate for testing of improvement strategies may be isolated.~   "
182203|NCT01179919|"~     One in three Americans are obese. Obese subjects may or may not need higher doses of the~     anti-flu drug known as Tamiflu (oseltamivir). The current study is being done to see if the~     FDA approved dose of oseltamivir will achieve similar concentrations in obese healthy~     volunteers compared to that previously shown in non-obese volunteers.~   "
182204|NCT01179906|"~     Aerobic training has been shown to favorably alter several of the known risk factors for~     coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It~     seems logical that if these risk factors were aggressively controlled in patients with~     chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise~     training) to support the pharmacologic interventions that are necessary for the control of~     the disease, then the rate of progression of the disease may be altered. However, to date,~     there is no clear research evidence to support this hypothesis. Therefore the aims of the~     proposed study are:~        1. To test the hypothesis that lifestyle interventions (i.e., dietary modification and~          regular, long-term aerobic exercise training) will favorably alter the natural~          progression of CKD in a sample of patients compared to a control group who will receive~          the current standard care.~        2. To explore possible mechanisms that could contribute to the observed changes.~   "
182205|NCT01179893|"~     Immunomodulation is effective in treating patients with myasthenia gravis (MG), but prior~     studies have not adequately defined if plasma exchange (PLEX) in superior to intravenous~     immunoglobulin (IVIG) in the treatment of myasthenia gravis. This study aimed to determine if~     PLEX was superior to IVIG in the treatment of patients with myasthenia gravis.~      Patients with MG requiring immunomodulation are randomized to IVIG or PLEX and treated with a~     full course of immunomodulation. The quantitative myasthenia gravis score (QMGS) will be~     evaluated as the primary efficacy parameter at day 14 to determine if PLEX is superior to~     IVIG.~   "
182206|NCT01179880|"~     The safety and pharmacokinetics of topical application with E6005 ointment compared to~     vehicle will be evaluated in Japanese male patients with atopic dermatitis. Additionally, the~     efficacy of topical application with E6005 ointment will be explored in Japanese male~     patients with atopic dermatitis.~   "
182207|NCT01179867|"~     The purpose of this study is to determine if a physician's use of electronic medication~     reconciliation software when writing a patient's discharge prescription will prevent adverse~     drug events and readmissions to the hospital. This electronic medication software will~     provide the physician with the most up-to-date list of medications the patient was taking~     before being admitted to the hospital, through a real-time link to the provincial drug~     insurance agency's administrative databases. It will also provide the list of medications the~     patient has taken while admitted to the hospital. With these two pieces of information, the~     physician will write the discharge prescription using the medication management software,~     print the discharge prescription for the patient, and the software will fax a copy of any~     prescriptions that should be stopped to the patient's community pharmacist.~   "
182208|NCT01179854|"~     The purpose of this study is to determine weather different doses of Remegal are~     effective,safety and tolerant in Additional Therapy for Patients With Refractory Partial~     Seizures and pharmacokinetics definition~   "
182209|NCT01179841|"~     This research is being done to test the effectiveness of an early intervention model for very~     young children at high risk for autism spectrum disorders (ASD) and their families. If~     children show improvement in this intervention, the investigators hope that the availability~     of public services of this type will be increased. Children between 11 months and 21 months~     old with Autism Spectrum Disorders, or with social and communication delays that indicate~     high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must~     start prior to the second birthday.~   "
182210|NCT01179828|"~     Drug therapy in patients with chronic low back pain is a major challenge for physicians. One~     of the problems is the lacking knowledge in prediction of drug efficacy in a chosen patient.~     Usually one of the classes of pain medication is given to patients with a similar clinical~     picture, although different pain mechanisms may be responsible for this clinical picture.~      Another reason for variable drug efficacy are genetic polymorphisms, this may be the reason~     why an unique drug produces different responses (from a lacking analgesic effect up to~     excessive effect or side-effects.~      Quantitative sensory testing is a method that documents alterations in the pain perception~     system. Linking genetic polymorphisms to quantitative sensory testing may give us a tool for~     anticipation of drug efficacy.~   "
182211|NCT01179815|"~     Currently, the estimated number of people with diabetes mellitus is approximately 387 million~     people worldwide. Due to population growth, urbanization, ageing and the rising prevalence of~     obesity the numbers of individuals with diabetes is increasing likewise. It has been shown~     that improving glycemic control is associated with a reduction in late complications of~     diabetes, such as cardiovascular and microvascular diseases. Therefore, treatment guidelines~     were established internationally by large and renowned associations and adopted by many~     countries.~      For Switzerland only sparse data exist on the actual implementation of such recommendations~     and on patient's well-being. The Swiss Diabetes Registry - SwissDiab Study is a prospective~     cohort study aiming at including and collecting data of virtually all patients regularly seen~     and treated at the study centers (≈ 500 patients each), irrespective of type, duration of~     diabetes or treatment . This allows the evaluation of diabetes treatment strategies at these~     centers. Furthermore, risk indicators for micro- and macrovascular complications, mortality~     as well as costs and quality of life will be assessed. Data will be recorded through an~     internet-based, electronic database specifically designed for this study. At a later~     perspective it is planned to extend data collection to general practitioner/family doctor~     networks in order to include a larger and more representative sample of patients with~     diabetes in Switzerland.~   "
182212|NCT01179802|"~     Until now it has been assumed that regular endurance training has a positive influence on~     cardiac function and that the positive effect increases with increasing intensity. However,~     little is known about the effects of intense endurance stress on the heart. According to~     current knowledge repeated exposure to strenuous endurance activity may lead to minor but~     possibly irreversible damage to the heart with resultant scarring of the heart's muscle.~      Within this study we attempt to find out by different analytical methods - in particular~     magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the heart~     muscle is affected by an intense endurance exercise, i.e. the Jungfrau-Marathon, and which~     changes can possibly be found. Due to repeated measurements we will obtain further~     information on the short-term course of possible changes.~      Hypotheses: A single bout of prolonged strenuous exercise (PSE) leads to transient alteration~     in cardiac function accompanied by the appearance of biomarkers for myocardial damage.~   "
182213|NCT01179789|"~     Ageing of the population is a major event in the world. Gerontological/geriatric literature~     unanimously indicate that physical exercise and diet are at present the two available~     fundamental approaches to contrast/prevent most of the age associated alterations. In the~     elderly the inflammageing, the oxidative stress and the alteration of the intestinal~     microbiota can be influenced by nutritional status and possibly corrected by an appropriate~     dietetic intervention:~      Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve~     the quality of individual diet for specific needs~   "
182214|NCT01179776|"~     Acute myocardial infarct patients with STEMI (ST-elevation on ECG) whom undergo a primary~     percutaneous cardiac intervention will following the standard treatment , received low dose~     of Ilomedin and to low dose of standard treatment for another 24 hours.~   "
182215|NCT01179763|"~     The purpose of this study is to examine retinal layer thickness in amblyopia.~   "
182216|NCT01179750|"~     Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once~     during operation. It was proved that a laparoscopic gastric resection showed significantly~     shorter operative time and less work load distribution, and more stability of bleeding than~     before an introduction of ultrasonic coagulating shears .~      In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for~     lymph node dissection or cutting of small vessels in some hospitals in Korea. However its~     usefulness or effectiveness has not been fully proved. There was only one report about using~     ultrasonic coagulating shears in open gastrectomy. The report contained small number of~     subjects and surgical procedures were different from the investigators.~      The investigators expect to reduce operative time and blood loss with ultrasonic coagulating~     shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure~     of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and~     shorten the removal time of a drain, which will also shorten the hospital stay.~      The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating~     shears in open gastrectomy including usefulness and effectiveness by a randomized controlled,~     prospective study.~   "
182217|NCT01179737|"~     The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in~     this population and to test the hypothesis that 6 months treatment with nilotinib will~     significantly reduce pulmonary artery resistance.~   "
182218|NCT01179724|"~     after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton~     pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing~     bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger~     acid suppression (high dose PPI) more effectively prevents bleeding after ESD~   "
182219|NCT01179711|"~     In most clinics, physicians reduce diopter of hyperopic glasses in older patients with~     accommodative esotropia. However, there are risks of decompensation in that practice. The~     authors are going to try measure the change of stability of eye alignment after reducing~     diopter of hyperopic glasses.~   "
182220|NCT01179698|"~     Bone tumor near the articular cartilage is hard to remove sufficiently without damaging~     adjacent joint. The purpose of this study was to evaluate the feasibility of~     navigation-assisted surgery for saving joint in bone tumor resection or curettage. In this~     study, the investigators hypothesized that computer-assisted surgery is feasible method to~     get both enough margin and joint salvage. Each of them is important intermediate factor for~     either oncologic outcome or functional outcome respectively. The investigators designed this~     study to find what proportion of patients who underwent computer-assisted resection could get~     enough margins using some criteria obtained by overlapping preoperative and postoperative~     images. The investigators also evaluated whether computer-assisted surgery can be feasible~     for joint saving using some criteria including functional outcome.~   "
182221|NCT01179685|"~     Melanoma antigen (MAGE) gene is known to be expressed in tumor cells, testis and placenta.~     The purpose of this prospective study was to investigate the sensitivity, specificity and~     accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of~     malignant pleural effusion.~   "
182222|NCT01179672|"~     The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once~     daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as~     measured by the weekly mean of the daily pain scores recorded in the participant's diary in~     participants with diabetic peripheral neuropathic pain.~   "
182223|NCT01179659|"~     The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth~     Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed~     conditions.~   "
182224|NCT01179646|"~     The objective of this study was to determine the single-dose bioequivalence of the test~     product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared~     with the reference product, a pantoprazole 40 mg delayed-release tablet formulation~     (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.~   "
182225|NCT01179633|"~     The purpose of this study was to demonstrate the effect of short treatment with active OPLON~     patches on Acne.~   "
182226|NCT01179620|"~     This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to~     prevent clotting during hemodialysis.~   "
182227|NCT01179607|"~     M0002, an orally active, selective non-peptidergic antagonist of the vasopressin V2 receptor~     inhibits vasopressin-induced water reabsorption from the kidney. Therefore the aquaretic~     effect of M0002 has a potential clinical benefit in the treatment of ascites and~     hyponatreamia in cirrhotic patients.~   "
182228|NCT01179594|"~     This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety~     of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in~     patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to~     receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or~     entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously~     weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36.~     Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target~     sample size is <500 patients.~   "
182265|NCT01179113|"~     The purpose of this study is to evaluate the effects of esmolol, a drug which is commonly~     administered during surgery to help control blood pressure and heart rate, on postoperative~     pain levels and requirements for pain medication.~   "
182229|NCT01179581|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)~     and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).~      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple~     oral administration will be evaluated, and, if applicable, the maximum tolerated dose~     determined.~   "
182230|NCT01179568|"~     The major goal of this 4-site, double blind, placebo-controlled intervention trial is to~     assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated Grief~     Therapy) to treat the symptoms of complicated grief.~   "
182231|NCT01179555|"~     Pt. 1 Diabetic retinopathy is a common eye condition among diabetic adults and can lead to~     severe vision impairment and even blindness. African Americans are more likely to have vision~     loss from diabetic retinopathy due to a variety of factors, including cultural barriers to~     care. The investigators aim to increase the rates of eye exams in diabetic African American~     adults by providing culturally relevant home-based interventions. These interventions will~     increase the knowledge about diabetes and the eyes and the awareness of ocular risks due to~     diabetes.~      206 African American adults, over the age of 65, with diabetes will be recruited from primary~     care clinics at Thomas Jefferson and Temple University. Eligible patients who consent to~     participate will have baseline information taken about medical and ocular history,~     understanding of diabetes and a hemoglobin A1C level obtained. The subjects will then be~     randomized to one of two treatment conditions: Behavioral Activation or Supportive Therapy,~     each of which will be delivered over 4 sessions. Behavioral Activation will consist of~     educational materials, referral assistance for eye clinics, and addressing patient specific~     barriers to care. Supportive Therapy will consist of supportive but non-directional~     interaction with the patient exploring the impact of aging and diabetes on the patient's~     life. The investigators hypothesize that more patients who receive Behavioral Activation will~     have a dilated fundus exam (the primary outcome variable), understand the risks of diabetic~     complications and feel less depression then subjects who receive Supportive Therapy.~   "
182232|NCT01179542|"~     The involvement of eukaryotic translation initiation factor 4E (eIF4E) in human placental~     implantation and in the pathological pregnancies: preeclampsia and IUGR.~   "
182233|NCT01179529|"~     This study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis,~     and to work out biomarkers predictive of treatment response.~   "
182234|NCT01179516|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     vortioxetine, once daily (QD), compared with placebo in adults with major depressive~     disorder.~   "
182235|NCT01179503|"~     A growing body of evidence suggests that vitamin D status is important in biologic processes~     involved in the maintenance of physical function. To advance the investigators understanding~     of the role of vitamin D in physical function, the investigators will conduct a feasibility~     pilot study to collect key information to help design a full-scale randomized trial to~     determine whether vitamin D supplementation will delay declines in physical function. The~     primary goals of the pilot study are to determine cost-effective strategies for identifying~     persons at high risk for functional decline with insufficient vitamin D levels, determine the~     serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient~     vitamin D levels, and provide preliminary data of key functional measures (balance, physical~     performance and muscle power) for the future larger study design. A secondary goal is to~     begin to examine potential mechanisms by which vitamin D supplementation may enhance physical~     performance by exploring the effects of vitamin D supplementation on changes in skeletal~     muscle gene expression.~   "
182236|NCT01179490|"~     The study objectives of this study are to determine the effects, safety, and pharmacokinetics~     of bendamustine for multiple myeloma to a regimen of bendamustine and prednisolone.~   "
182237|NCT01179477|"~     The purpose of this multicenter post-approval study is to evaluate the acute and chronic~     performance of the QuickFlex® μ 1258T left ventricular lead.~   "
182238|NCT01179464|"~     The purpose of this study is to investigate the effects of aminobiphosphonate treatment on~     the phenotype and function of circulating Vgamma9Vdelta2-T cells and to determine whether~     these effects are inhibited by simultaneous treatment with statins.~   "
182239|NCT01179451|"~     The purpose of this study is to determine whether there is late cardial involvement in~     children diagnosed with post streptococcal reactive arthritis after discontinuation of~     prophylactic antibiotic therapy.~   "
182240|NCT01179438|"~     Dexmedetomidine administration for minor procedure, such as extracorporeal shock wave~     lithotripsy, provides good quality of sedation and analgesia. Dexmedetomidine is a highly~     selective α2-adrenergic receptor agonist which causes sedative effects and reduces opioid~     requirements in the perioperative period. Extracorporeal shock wave lithotripsy may cause~     pain and result in tachycardia and vasoconstriction-related hypertension. Surgical or~     procedural stress may induce inflammation and it may cause further microthrombosis. Both~     vasoconstriction and microthrombosis will alter the microcirculatory status. Dysfunction of~     microcirculation may impair tissue perfusion and result in organ dysfunction. Dexmedetomidine~     may induce vasodilation by slow intravenous infusion for sedation. Dexmedetomidine may also~     reduce inflammation. After reviewing the literature, the investigators found that the effect~     of dexmedetomidine on microcirculation was not well investigated. By application of the~     non-invasive technique of sidestream dark field imaging, the investigators can investigate~     the vessel density, percentage of perfused vessels, and microvascular flow index on~     sublingual vessels.~      The goal of this study is to identify the effect of dexmedetomidine on sublingual~     microcirculation in patient undergoing extracorporeal shock wave lithotripsy.~   "
182241|NCT01179425|"~     The purpose of this study is to explore sex differences in cognitive functioning and~     responses to marijuana-related items, and to determine whether stress impacts these measures.~      Hypothesis 1: Attentional bias will be greater for marijuana cues in male marijuana-dependent~     subjects relative to female marijuana-dependent or non-dependent male controls.~      Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in~     attentional bias and cognitive functioning than marijuana-dependent males.~   "
182242|NCT01179412|"~     The purpose of this study is to determine the outcomes of treating epidemic~     keratoconjunctivitis with 2% povidone-iodine.~   "
189741|NCT01080924|"~     This study is aiming at evaluating whether low frequency ultrasound spectroscopy is a~     sensitive tool to detect broncholytic effects in patients with obstructive airway diseases.~   "
182243|NCT01179399|"~     Overview of Study Design: This is a phase 1, multicenter, open-label, multiple-dose,~     dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK),~     and antitumor activity of TAK-960 in patients with advanced nonhematologic malignancies. This~     study will be the first to administer TAK-960 to humans. The patient population will consist~     of adults with a nonhematologic malignancy for which standard treatment is no longer~     effective or does not offer curative or life-prolonging potential, or for which no standard~     treatment is available.~   "
182244|NCT01179386|"~     Adolescents suffering of ADHD may have impaired driving performance. The investigators would~     like to check the differences in driving performance in young adults(aged: 15-18 years) with~     ADHD by driving simulator and seat pressure mapping with and without methylphenidate~     medication.~   "
182245|NCT01179373|"~     The primary objective of this trial is to assess the ability of Transcranial Magnetic~     Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training,~     to improve cognitive performance in patients with Alzheimer's disease which received drug~     treatment. This study is a single-center, double-blind 4 months duration trial.~   "
182246|NCT01179360|"~     To determine if combined [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission~     tomography/computed tomography (PET/CT) is performant enough with respect to detecting~     residual lymph node involvement after chemoradiation in order to omit planned neck~     dissections in patients with locally advanced potentially operable, N2 and N3 head and neck~     squamous cell carcinoma (HNSCC).~      Primary study hypothesis: The lower bound of the 95% confidence interval (CI) of the negative~     predictive value (NPV) of FDG PET/CT to detect residual malignant lymph node involvement at~     12 weeks after completing chemoradiation will exceed 85%.~   "
182247|NCT01179347|"~     To date, there have been no formal clinical studies completed using tiotropium in CF~     patients. While there is a large body of evidence demonstrating the efficacy and safety of~     tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little~     is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis.~     Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic~     tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric~     and adult CF. The phase III trial (205.438) is a part of the approved Paediatric~     Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.~   "
182248|NCT01179334|"~     Pulmonary Arterial Hypertension (PAH) is a severe progressive disease with a high mortality.~     Although several drugs are available for the treatment of PAH none offer a cure, therefore~     there is still a high medical need for new treatments.~      Soluble guanylate cyclase (sGC) is one of the chemicals involved in the pathways controlling~     vascular tone, which is impaired in patients with PAH. This causes constriction and~     thickening of the blood vessels wall in the lungs and increase of blood pressure in the~     lungs. This can lead to the very debilitating symptoms of PAH such as tiredness, shortness of~     breath on exertion, collapse and often the inability of the patient to perform their daily~     life activities.~      Inhalation of Nitric Oxide, which activates sGC is used to treat PAH, but its effect wears~     off as soon as inhalation stops. Direct stimulation of sGC using this new compound Riociguat~     may be a new approach for the treatment of PAH.~      The phosphodiesterase 5 (PDE5)-inhibitor Sildenafil is one of licensed treatments for PAH.~     The Patent Plus is a double-blind, placebo-controlled safety study, designed to investigate~     the effect of Riociguat on blood pressure in patients with PAH when given in combination with~     Sildenafil.~   "
182249|NCT01179321|"~     The purpose of this study is to determine the impact of malnutrition screening and nutrition~     intervention on acute aged care patient outcomes.~   "
182250|NCT01179308|"~     Test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to~     general anesthesia alone.~   "
182251|NCT01179295|"~     This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral~     BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles~     in Japanese patients with advanced solid tumors~   "
182252|NCT01179282|"~     Subjects who have a clinical history of perennial rhinitis symptoms associated with dust~     exposure or not associated with other perennial allergens, will have a positive challenge~     with Dermatophagoides pteronyssinus. Subjects will be ppt negative and intradermal skin test~     positive to Dust p Challenges will be performed with placebo or Dp extract three times daily~     each for 2 weeks.~      Primary endpoint after nasal challenge with Dust p Mean Symptom score increase by greater~     than or equal to 2 from baseline. Secondary Outcomes Mean decrease in PNIF by greater than~     15percent from baseline. Mean increase in nasal lavage PGD2 and ECP by greater than 15percent~     from baseline levels.~      Correlation between the orthogonol diameter of the wheal and flare of the intradermal skin~     test and the degree of symptom worsening during the nasal challenge.~      These results will provide evidence for the continued use of the intradermal skin test in~     evaluating allergic rhinitis.~   "
182253|NCT01179269|"~     Lung cancer is the leading cause of cancer worldwide with approximately 1.2 million new cases~     each year. Non-small cell lung cancer (NSCLC) accounts for greater than 80% of all lung~     carcinomas in Western countries. Surgical resection is the treatment of choice for patients~     with early stage disease (Stage I and II), but at least 50% of these patients will relapse~     locally and/or develop distant metastases. Furthermore, 70% of patients with NSCLC are~     non-resectable at the time of their diagnosis due to either locally advanced or metastatic~     disease. The long-term prognosis for patients with NSCLC remains poor with the overall 5-year~     survival rate less than 15%. The low survival rate may be attributed to the high incidence of~     unresectable disease at presentation and the inability of systemic therapy to cure metastatic~     disease. There is a clear need for improvement in the treatment of NSCLC.~   "
182254|NCT01179256|"~     Curcumin has antioxidant properties and in animal models has numerous molecular targets, many~     of which are intracellular, such as transcription factors AP-1 and NF. As such, it inhibits~     the secretion of both pro-inflammatory (TNF-, IL-6) and anti-inflammatory (IL-10) cytokines,~     possibly by inhibiting transcription factors such as nuclear factor-B (NF-B) and activator~     protein-1 (AP-1) (Wong et al).~   "
182406|NCT01177267|"~     Using a retrospective database analysis, OA patients taking at least one CYP450-metabolized~     opioid (codeine, fentanyl, hydrocodone, methadone, oxycodone, or tramadol) and at least one~     other prescription drug metabolized via the CYP450 system were evaluated for an incident~     drug-drug exposure (DDE), which places them at risk for experiencing a pharmacokinetic~     drug-drug interaction (DDI).~   "
182255|NCT01179243|"~     Recent research has focused on the investigation of sublingual microcirculatory alterations~     in different patient categories, like cardiac surgery and sepsis. The microcirculation plays~     a pivotal role in tissue oxygenation and can be non invasively visualized by sidestream dark~     field (SDF) imaging.~      The objective is to carry out a international multi center study to investigate the~     prevalence of microcirculatory alterations in intensive care patients. Up to the present~     time, a comprehensive prevalence study like this has not been carried out.~   "
182256|NCT01179230|"~     Many stress tests being done today have two parts, the stress test and the pictures of your~     heart. The investigators are comparing a newer technique to obtain the pictures (PET imaging)~     to the standard method (SPECT imaging). However, it is not known if the new test is better~     than the old test. It is important to have a standard to compare these tests to, and that is~     why people who will be getting a cardiac catheterization are being asked to participate. The~     information about your arteries from the cardiac catheterization will be used to judge which~     stress test is better. The investigators hypothesize that the newer method (PET imaging) will~     be more accurate than the old method (SPECT) in detecting heart disease.~   "
182257|NCT01179217|"~     The purpose of this research is to evaluate the effects of L-glutamine as a therapy for~     Sickle Cell Anemia or Sickle ß0 Thalassemia as evaluated by the number of occurrences of~     sickle cell crises.~   "
182258|NCT01179204|"~     In this consecutive, prospective cohort study trial the investigators evaluate if~     preoperative pain response upon heat stimulation is predictive for acute and subacute~     postoperative pain after total knee arthroplasty.~   "
182259|NCT01179191|"~     The purpose of the research study is to find out if opioid dependent chronic pain patients~     who are judged by their physician to be eligible to change their current opioid medicine and~     to participate in this study can be successfully adjusted to a stable dose of EMBEDA~     (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's~     risk for prescription opioid abuse, misuse and diversion.~   "
182260|NCT01179178|"~     The investigators have taken part in the development of simple muscle function tests and~     studied physical training and energy turnover in patients with chronic obstructive pulmonary~     disease, COPD. The investigators have found that muscle wasting in COPD is related to poor~     prognosis and that physical training might lead to improved, less energy-demanding muscle~     function. Elderly subjects also suffer from muscle wasting that leads to frailty, poor~     autonomy and, secondarily, fractures. In the planned study the investigators will validate~     simple muscle function tests (hand grip strength, heel rise test, voluntary quadriceps muscle~     strength, 30 m walking test and balance tests) in both groups by relating them to an~     involuntary, magnet stimulated, test of quadriceps force, HRQL, tests of body composition~     (impedance, DXA) and recordings of physical activity. The relation between food intake,~     systemic inflammation, muscle mass and function will be analysed.~      The study has been ethically approved and started in COPD patients and will be expanded to a~     representative sample of elderly.~      Simple, evaluated muscle function tests applied in primary care may be used for early~     detection of muscle dysfunction in COPD patients and elderly so that early intervention~     against impaired muscle function can be started. Analyses of food intake and of inflammatory~     markers might identify factors of special importance for muscle dysfunction, which eventually~     might lead to improved dietary therapy and pharmacological interventions.~   "
182261|NCT01179165|"~     The purpose of this study is to investigate the prevalence of cardiac disease/coronary artery~     disease and diagnostic yield of different non-invasive methods in patients with type 2~     diabetes 40-75 years of age at examination. Exercise tests, Doppler echocardiographic~     examination with Tissue Velocity Imaging, stress Echocardiography, transthoracic Doppler of~     coronary arteries with coronary flow reserve, and cardiac MRI with late enhancement at rest,~     and perfusion after vasodilatation stress will be used in the study. A subpopulation will in~     addition measure forearm vasodilation(FMD) and CFR before and after 4 months of exercise~     training.~   "
182262|NCT01179152|"~     During the second week of September( week 38 of the year)there are recorded data of~     exacerbation of asthma all over the world, including Israel. A short preventive treatment of~     6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and~     hospitalization.~   "
182263|NCT01179139|"~     The purpose of the study is to better understand the causes of chronic rhinosinusitis~     (CRS)and to determine if being around secondhand cigarette smoke causes swelling in the~     sinuses. To answer this question, we are inviting healthy volunteers, volunteers with chronic~     sinusitis, and volunteers with chronic sinusitis with nasal polyposis to complete a~     questionnaire and undergo a series of tests. These tests will measure their allergies, their~     exposure to cigarette smoke and the swelling in their sinuses. We are asking you to take part~     because you are in one of these groups. About 166 people will take part in this research~     study. All subjects will be enrolled at Massachusetts General Hospital (MGH). The Flight~     Attendants Medical Research Institute (FAMRI) and the Harvard Clinical and Translational~     Science Center Harvard Catalyst) are paying for this study.~   "
182264|NCT01179126|"~     Multivessel disease has been reported to occur between 40 and 60% of patients with ST-segment~     elevation myocardial infarction (STEMI) and has been associated to a worse prognosis.~     Multivessel revascularization offers a myriad of potential advantages as enhance of the~     collateral blood flow, greater myocardial salvage, the stabilization of other lesions that~     can be potentially vulnerable, and the achievement of a complete revascularization, factor~     that is associated with a better prognosis. On the other hand, the prolongation of procedural~     duration, the hazard of contrast induced nephropathy and the peri-procedural complications~     can limit the widespread of this practice.~      To date, very few observational studies have focused in the multivessel revascularization~     with disparity of results. Whereas ones have observed an increase of adverse cardiovascular~     events and thus not recommend it, others have shown neutral results.~      Stress echocardiography has been shown to be an adequate technique for the diagnosis of~     coronary artery disease and could be an appropriate tool for selecting the lesions that need~     to be revascularized because they induce large areas of ischemia. However, this technique has~     also limitations like the high operator-dependence.~      Therefore, the investigators sought to study if the complete multivessel revascularization of~     patients with STEMI treated by means of primary percutaneous coronary intervention (PCI) has~     an impact on prognosis compared to a strategy of treating only those non-culprit lesions that~     produce large areas of ischemia in a stress test.~   "
182266|NCT01179100|"~     This study will evaluate the effect of intraoperative lidocaine infusion on postoperative~     orientation and concentration in elderly patients having general anesthesia for orthopedic~     surgeries requiring a minimum 2 days hospitalization.~      This study will also aim to determine whether intraoperative lidocaine infusion during~     general anesthesia improves recovery and patient outcome, as well as to determine whether~     lidocaine infusion decreases postoperative opioid (pain medication) usage.~   "
182267|NCT01179087|"~     The purpose of the study is to investigate the prevalence, clinical predictors and~     consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung~     transplant recipients.~   "
182268|NCT01179074|"~     To assess the benefits of oesophageal stenting and external beam radiotherapy over~     oesophageal stenting alone in patients with inoperable oesophageal cancer~   "
182269|NCT01179061|"~     The apelin-APJ system is a recently discover hormone system that has several important~     actions in the cardiovascular system. Apelin causes the heart pump with more force and also~     causes blood vessels to relax. Studies to date show that people with reduced pumping function~     of the heart have lower levels of apelin in the bloodstream compared to people with normal~     heart function. We have previously given apelin to healthy volunteers and people with reduced~     pumping function and this increases the heart's contraction. However, this has only been~     assessed over a short time period, around fifteen minutes, and we now want to know if this~     effect is seen over a longer period.~   "
182270|NCT01179048|"~     This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this~     trial is to determine the long term effect of liraglutide on cardiovascular events in~     subjects with type 2 diabetes.~   "
182271|NCT01179035|"~     The purpose of this study is to study the effectiveness of the Transitions Clinic, a~     post-release clinic for parolees with chronic medical conditions, in achieving increased~     primary care engagement, lower rates of inappropriate hospitalizations, psychiatric emergency~     service and emergency department use, and decreased recidivism.~      We hypothesize that subjects receiving parolee-targeted care in the Transitions Clinic will~     have increased rates of non-emergency department ambulatory care and outpatient mental health~     care, lower rates of hospitalization, psychiatric emergency service (PES) utilization,~     emergency department (ED) utilization, decreased total hospital length of stay, and decreased~     recidivism compared to patients receiving primary care from other safety-net providers.~   "
182272|NCT01179022|"~     Incidence of Bacteremia Following Argon Plasma Coagulation in Patients with Endobronchial~     Lesions~   "
182273|NCT01179009|"~     Treatment resistant depression (TRD) is a major public health problem. Current therapeutic~     options for this patient population remain limited. With all available treatments, only a~     sub-set of those patients who achieve an antidepressant response are likely to achieve~     treatment-induced remission. The need for antidepressant medication that can provide both~     rapid and long lasting relief of TRD symptoms is widely recognized. There is new evidence~     that drugs that block NMDA glutamate receptors (NMDA antagonists) are promising candidates~     for meeting this need. Existing studies in TRD have used only a low-dose, brief infusion of~     ketamine that would not be expected to re-sensitize the NMDA receptor; in agreement with this~     theory, these prior studies have found only temporary improvements of depression. Our key~     hypothesis is that a higher-dose, longer-term ketamine infusion, such as that used in chronic~     pain studies, would provide a more robust and lasting improvement from depression.~      Accordingly, we will be test whether a 100-hour ketamine infusion would be more effective~     than the standard 40-minute ketamine infusion currently used in other TRD studies. We will~     randomize subjects to one of 2 arms: (1) 100-hour (+/- 4 hours) ketamine infusion plus~     clonidine for the entire infusion (2) 40-minute ketamine infusion (plus clonidine) following~     a 100+/- hour saline infusion. All subjects will receive clonidine, an alpha-2 agonist, to~     minimize side effects of ketamine (namely, brief/mild psychotic and cognitive symptoms).~      A subset of 20 patients with TRD will receive a 100-hour (+/- 4-hours)ketamine infusion with~     head MRIs pre (2) and post (1) infusion. Little research has been done on the mechanism of~     ketamine's putative antidepressant action. There is now a consensus that, in early stages of~     the novel treatment development for depression, clinical studies should be paired with~     mechanistic studies (neuroimaging) to understand the underlying mechanism and validate this~     as a treatment target. Ketamine is thought to have an antidepressant effect by increasing~     synaptic connections and therefore increasing connectivity in critical cognitive/emotional~     circuits.~   "
182274|NCT01178996|"~     The purpose of the study was to determine safety and efficacy of 48 weeks treatment with~     Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and~     ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and~     not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in~     comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and~     placebo.~   "
182275|NCT01178983|"~     In the recent decades, with technology development, computer workstation has become~     fundamental both at work and at home environments, and is now used routinely for many~     purposes. Musculoskeletal disorders (MSD) are most often characterized by backaches, neck and~     upper extremities pain, discomfort and pain in joints, muscles and soft tissues. Since it has~     been found that many musculoskeletal disorders are connected, among others, to biomechanical~     and psychosocial factors relating to a person's work environment, the literature refers to~     them as Work Related MSD (WRMSD). Risk factors correlated with WRMSD include repetitive~     motions, awkward positions or static muscle loading over prolonged periods of time, use of~     high keystroke force, direct mechanical pressure, vibration and extreme temperatures.~     Computer operators found to be sitting statically for a long time in front of the computer~     and keyboard, with limited options of changing body position. Psychosocial factors have also~     been implicated in the workstation musculoskeletal disorders with computer operators. Workers~     with WRMSD may suffer from persistent pain, loss of function and work disability. Therefore,~     it may include changes in the employment and earnings for injured workers. The complex nature~     of these injuries suggests that workplace rehabilitation interventions are a crucial aspect~     of treatment management.~      The main objective of this study is to explore the use of biofeedback intervention, based on~     tele-rehabilitation principle, with computer operators suffer from WRMSD. Treatment efficacy~     will be tested by use of RULA (Rapid Upper Limb Assessment) method. Data analysis will be~     done by ANOVA Repeated Measures.~      Hypothesis: Biofeedback intervention, based on tele-rehabilitation principle, will be found~     effective with computer operators suffer from WRMSD.~   "
182276|NCT01178970|"~     The aim of the study is to prevent falls related to poor lower body strength adn balance in~     the elderly.~   "
182277|NCT01178957|"~     The purpose of this study is to estimate the acute effect of hyperglycemia on~     Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion.~   "
182407|NCT01177254|"~     Using a retrospective analysis of a large commercial claims database and a Medicare database,~     the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back~     pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450~     enzyme system, concomitant with other CYP450-metabolized drug(s).~   "
182278|NCT01178944|"~     This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients~     with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by~     surgery or has spread from the primary site (place where it started) to other places in the~     body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving pralatrexate with oxaliplatin may be an effective~     treatment for esophageal, stomach, or gastroesophageal junction cancer.~   "
182279|NCT01178931|"~     The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and~     the vaginal progesterone, used for luteal phase support.~      (Initial start date was January 2009 but not for patients' recruitment only for paper work,~     documents, team organization, statistical pre-work actions and to gain the official approval~     of Institutional Review Board. The recruitment started in October 2010 and continued until~     October 2013.)~   "
182280|NCT01178918|"~     This is a prospective observational study with recruitment of healthy volunteers from~     consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and~     Allergic Diseases, Golnik, Slovenia.~      The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1~     vaccines.~   "
182281|NCT01178905|"~     To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the~     prevention of Cytomegalovirus (CMV) transmission in preterm infants (<32 weeks gestational~     age or <1500 g birth weight) under clinical conditions. Inactivation will be done only during~     the period of infectivity of breast milk, characterized by viral excretion strongly~     associated with subsequent infection, monitored by periodic virologic examinations of BM and~     urine of the infant. Thus the investigators hypothesis is that no CMV transmission through~     breast milk will occur using a gentle ultrashort heat inactivation procedure applied to~     infective breast milk.~      The protocol has been approved by the ethics committee of Tuebingen University Hospital.~   "
182282|NCT01178892|"~     This study is the second clinical trial to be conducted by the Menopause Strategies - Finding~     Lasting Answers for Symptoms and Health (MsFLASH) research network, a group of investigators~     conducting clinical trials designed to find new ways to alleviate the most common, bothersome~     symptoms of the menopausal transition.~      In this twelve-week clinical trial, 374 women aged 40-62 who are in the late menopausal~     transition or postmenopausal and experiencing bothersome hot flashes will be randomized to~     one of three behavioral intervention groups: yoga, exercise, or usual activity. All women~     will simultaneously be randomized to receive omega-3 supplementation or a matching placebo.~      The primary aims of this trial are to compare the magnitude of changes in perceived,~     self-reported frequency and bother of vasomotor symptoms (VMS) before and after the~     intervention between yoga and the usual activity comparison group, between exercise and the~     usual activity comparison group, and between omega-3 fatty acid supplementation or placebo.~     The hypotheses to be tested are:~        1. Women assigned to yoga will report lower frequency and less VMS bother than women~          assigned to the usual activity group at the end of a 12-week study period.~        2. Women assigned to aerobic exercise at moderate-vigorous intensity will report lower~          frequency and less VMS bother than women assigned to the usual activity group at the end~          of a 12-week study period.~        3. Women assigned to omega-3 fatty acid supplementation will report lower frequency and~          less VMS bother than women assigned to the placebo group at the end of a 12-week study~          period.~      The omega-3 component of the study is double-blinded. For yoga, exercise, and usual activity,~     the outcomes assessors are blinded to the randomization assignments.~   "
182283|NCT01178879|"~     The purpose of this study is to determine whether telehealth nursing consultations of chronic~     obstructive pulmonary disease (COPD) patients are superior to hospital readmissions.~   "
182284|NCT01178866|"~     Evaluate less employed markers of tissue hypoperfusion as venoarterial carbon dioxide partial~     pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) combined to other~     classically studied markers as predictive factors of complicated clinical course after~     cardiac surgery in patients with left ventricular dysfunction.~   "
182285|NCT01178853|"~     This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug~     interaction study.~   "
182286|NCT01178840|"~     This is a comparative, open-label two-period crossover study of up to 505 couples comparing~     the PATH Woman's Condom to the FC2 female condom. California Family Health Council will~     enroll up to 505 couples to have 375 complete both periods. The study will provide data on~     functional performance, vaginal semen exposure, safety, and acceptability of the two female~     condoms.~      Both partners will be required to come to the clinic to be consented for the study. If both~     members of the couple meet all eligibility requirements, they will each sign an informed~     consent form and will be enrolled as a couple. The couples will be randomized to one of two~     female condom use sequences for the two periods (WC then FC2 or FC2 then WC). For the first~     period of 2-4 weeks, the couple will be asked to have sex once without a condom and 4 times~     using the first assigned female condom. For the second period of 2-4 weeks, the couple will~     be asked to have sex 4 times using the second assigned female condom. In the first period,~     the couple will have one act of unprotected sex for which they will collect pre- and~     post-coital vaginal swabs. The couple will also use 4 female condoms of the assigned type.~     They will be asked to collect pre- and post-coital vaginal swabs and a post-coital swab from~     the condom interior. The couple will complete a detailed Condom Use Questionnaire together~     after each condom use. An Acceptability Questionnaire will be completed separately by males~     and females at the end of each study period. Couples may have additional acts of sex during~     each period as they desire but will not have sex at least 48 hours prior to each study sex~     act. After a follow-up visit, the procedures will be repeated with 4 of the second assigned~     condom type but without the collection of vaginal swabs at unprotected intercourse. Each~     couple will be enrolled for about 2-3 months, depending on the intervals between sex acts.~     Clinicians evaluating product-relatedness of AEs will be blinded to the condom type used.~     Male partners will be requested to attend the final visit, and, if they experience adverse~     events, the followup and/or unscheduled visits.~   "
182287|NCT01178827|"~     This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®)~     and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with~     overactive bladder and age associated memory impairment.~   "
182288|NCT01178814|"~     This is a prospective trial of Revlimid for subjects who have a blood cell cancer called~     myelodysplastic syndrome (MDS). Cells in their marrow make proteins through messages that are~     carried from the genes. The amount of the message tells researchers if the protein it is~     going to make is high or low. This is known as expression of genes. The purpose of this study~     is to conduct a prospective trial testing the idea that expression of specific genes can help~     to predict which patients will respond to study drug administration with Revlimid~     (lenalidomide).~   "
182530|NCT01175655|"~     The primary aim of this study is to establish the safety of infusions of Mesenchymal Stromal~     Cells (MSC) from related or unrelated Human Leukocyte Antigen (HLA) identical or HLA~     mismatched donors in the management of bronchiolitis obliterans syndrome after lung~     transplantation.~   "
182289|NCT01178801|"~     As a result of increasing adoption of health information systems in hospitals, more and more~     health records can be gathered and accumulated in the healthcare data repository. For this~     reason, the opportunity of analyzing and mining the healthcare data for quality improvement~     is increasing and becoming more and more important.~      The purpose of the project is to gather the clinical data relevant to liver cancer, and adopt~     the knowledge discovery and mining modules in information technology (IT) for analyzing and~     discovering the knowledge from the gathered clinical data.~      We can analyze the gathered clinical data for comparing the outcomes of different treatment~     strategies, finding out new diagnosis and staging criteria and factors, and other hidden~     knowledge included in the clinical data.~      Afterwards, the discovered results and the mining algorithms can be shared though the~     sharable knowledge mining platform provided by our project.~   "
182290|NCT01178788|"~     Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and~     17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of~     cervical shortening, in the present pregnancy.~      Main outcome: Delivery before 37 weeks.~      Secondary outcomes: Gestational age at delivery, Delivery <32, <35 wks, hospital admissions~     before delivery, birth-weight centile, NICU admission, days of NICU admission, days of oxygen~     supply, composite neonatal complications, congenital neonatal malformations and anomalies.~      Allocated treatments will be:~      Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per~     vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical~     observation~      Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg~     repeated once 24 hours apart) will be permitted. Is not allowed the treatment with tocolytics~     per os. Any treatment will be recorded.~      Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit will~     be competitively assigned later. Results are expected 20-24 months from starting.~      Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50%~     (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160~     patients/arm, with a total of 480 patients.~      Data analysis: Methodological Unit will assign randomized treatment through a web site and it~     will collect data through the same way.~   "
182291|NCT01178775|"~     The aims of this three-year study are to:~        1. develop and validate a perceived meaning of fatigue scale~        2. examine the effect of individualized patient education and walking programs on~          alleviating fatigue in patients with gastric or colorectal cancer,and further explore~          the relationship between the perceived meaning of fatigue and intervention outcome.~   "
182292|NCT01178762|"~     Chlamydia trachomatis is one of the major causes of sexually transmitted disease and also the~     leading infectious cause of blindness in the world.Treatment of C. trachomatis eye infection~     has involved for a long time. The efficacy of single dose azithromycin has already been~     demonstrated as effective in the treatment of both trachoma and adult inclusion~     conjunctivitis.However, in our clinical experience, some patients of chlamydial~     conjunctivitis may require augmented single dose azithromycin treatments before C.~     trachomatis is eradicated. In this way, we would like to known the efficacy of single dose~     and augmented single dose azithromycin in the treatment of chlamydial conjunctivitis.~   "
182293|NCT01178749|"~     The aims of this three-year study are to explore symptom experience and its related factors~     for the patients with chronic hepatitis C Infection receiving interferon-α with ribavirin for~     24 weeks and further to predict the relative risk of failure or occurence of severe side~     effects which interrupt the treatment.~   "
182294|NCT01178736|"~     The purpose of this study is to implement a community-based combined program for early~     detection of breast, cervical, ovarian and endometrial cancer in low-resource countries~     delivered through a free standing or a mobile Well Woman Clinic. The goals of this program~     are to downstage cancers and improve mortality rates using low-cost early detection methods.~     These programs will be implemented in regions where early cancer detection strategies are not~     in place and cancers present at advanced stages with resultant high mortality. Currently,~     there are three target project sites: Cambodia (June 2011), India (June 2011), and Brazil~     (March 2011). Memorandums of Understanding have been secured with local health organizations~     in each region to establish clinic operations. Each clinic would serve an approximate target~     population of 100,000 amongst whom about 12,000 eligible women (4-5,000 annually) will be~     invited to be screened for breast and cervical cancer over a three-year time span.~   "
182295|NCT01178723|"~     Studies has found a connection between breakfast consumption and obesity and obesity-related~     complications, but only few studies examined the effect of breakfast size.~      The purpose of this study is to examine the effect of breakfast size on several parameters in~     adults with Type 2 diabetes mellitus.~   "
182296|NCT01178710|"~     It is well know that statins have been used to low cholesterol to prevent and treat coronary~     artery disease for many years. It was also reported that statins could protect endothelial~     function and cardiac function during coronary artery bypass graft. However, some results were~     controversial. Also, there is no clinical data available on statin cardiac protection during~     surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are~     trying to see whether statins can protect heart injury during cardiac surgery in Chinese.~     Part of patients will receive statin treatment and part of will not before surgery in the~     study. Both patients' heart function will be measured and compared after surgery to determine~     whether statins can protect heart injury during heart surgery.~   "
182297|NCT01178697|"~     This randomized clinical trial is conducted to evaluate the effect of three intravitreal~     injections of bevasizumab versus two intravitreal injections of triamcinolone in acute~     central retinal vein occlusion. The outcomes are visual acuity and central macular thickness.~     The follow-up time is 6 months.~   "
182326|NCT01178320|"~     Heart attacks and strokes caused by the unstable atherosclerotic plaques remain the leading~     cause of death in the United States. Unstable plaques often have more fat than stable~     plaques. This study will investigate if a treatment with LDL-lowering plus HDL-raising~     compared with LDL-lowering alone would more effectively reduce the plaque fat content~     assessed by magnetic resonance imaging (MRI), therefore, further reducing heart attacks and~     strokes.~   "
182451|NCT01176682|"~     The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis~     and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in~     usual clinical practice, how patients comply with their treatment and how satisfied they are~     with their treatment.~   "
182298|NCT01178684|"~     This study will provide the range of Epidermal Nerve Fiber Density (ENFD) typically seen in~     Thai individuals. ENFD values from Thai HIV-negative subjects without neuropathy will be used~     as appropriate reference norm for Thai HIV-positive subjects. In particular, comparison of~     ENFD values from Thai HIV-negative subjects with baseline ENFD values in Thai HIV-positive~     subjects prior to highly active antiretroviral therapy (HAART) will allow examination of the~     effect of HIV per se on ENFD. ENFD from Thai HIV-positive subjects on long-term d4T~     (stavudine) with and without neuropathy will also provide reference ENFD values at the~     extremes of the disease process i.e. extent of ENFD decrease in subjects with d4T-induced~     symptomatic neuropathy and in subjects completely free of disease despite d4T treatment for~     comparison with Thai HIV-positive subjects on short-term d4T in SEARCH 003 study.~   "
182299|NCT01178671|"~     The overall goal of this study is to examine the efficacy of the combination of mirtazapine~     and sertraline in the treatment of posttraumatic stress disorder (PTSD). Sertraline is~     FDA-approved for PTSD, but it is often not fully effective. The combination of mirtazapine~     and serotonin reuptake inhibitors like sertraline has appeared highly effective in a related~     disorder -- depression.~      In this study, sixty patients with chronic PTSD will be randomized to treatment with either~     sertraline + mirtazapine or sertraline + placebo for 12 weeks. Patients who show at least a~     minimal response after 12 weeks will continue for another 12 weeks on the same treatment.~   "
182300|NCT01178658|"~     The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide,~     cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation~     in patients with non-Hodgkin lymphoma.~   "
182301|NCT01178645|"~     The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide,~     cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation~     in patients with non-Hodgkin lymphoma.~   "
182302|NCT01178632|"~     Phase III, double blind, randomized study, controlled by Valeriana officinalis L for~     evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and~     Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and~     be followed by a post treatment visit.~   "
182303|NCT01178619|"~     Intrauterine growth restriction is being suspected in cases where the fetal estimated weight~     is less then the 10 th percentile for its gestational age. Abdominal circumference is the~     most influenced measurement in this cases. Head circumference on the other hand can be or not~     be influenced. Previous studies have shown that transverse cerebellar diameter (TCD) is~     constant to gestational age and is not influenced by IUGR.Other showed lower TCD in IUGR~     fetuses. We would like to study the differences in cerebellar, vermian and corpus callosum~     growth between normal to IUGR fetuses and between symmetrical and asymmetrical IUGR. In this~     observational study we will include pregnant women between 28-37 gestational week with a~     singleton otherwise normal pregnancies. We will measure the fetal TCD, vermian distances and~     the CC, abdominal circumference, head circumference and femur length. we will compeer these~     measurements according to the following groups:normal fetuses, symmetrical and asymmetrical~     IUGR.~   "
182304|NCT01178606|"~     Sonographic coronal section in the lateral fetal ventricles shows echogenic area in the~     ventricles borders creating an halo around the ventricles. Histologically this area~     correlates to the Stratified transitional field. In this study we would like to measure this~     area for the purpose of creating a nomogram.~   "
182305|NCT01178593|"~     This randomised controlled trial (RCT) aimed at assessing the efficacy of hypnotherapy in~     group sessions (GHT) with a 12-months follow-up.~   "
182306|NCT01178580|"~     Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in~     adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these~     patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response~     as seen in sepsis.~      The aim is to study the fibrinolytic activity in patients with CAP alone versus CAP with~     parapneumonic effusions with and without empyema.~   "
182307|NCT01178567|"~     Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and~     laparoscopic adjustable gastric banding.~   "
182308|NCT01178554|"~     The Clinic Treatment Project tested two alternative methods of delivering evidence-based~     practices within public community-based mental health clinics, using training and supervision~     procedures designed for the settings and users.~   "
182309|NCT01178541|"~     Study designed to measure simultaneously the width of both lateral ventricles of the fetal~     brain. Thus, will enable to evaluate the normal asymmetry that may exist between the right~     and the left ventricles during the pregnancy.~   "
182310|NCT01178528|"~     Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological~     interventions have been proven effective in improving exercise capacity. At the presence~     there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity.~     Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left~     ventricular dysfunction and heart rate > 70 bpm. The association of ivabradine and atenolol~     has been proven effective in increasing exercise tolerance in patients with ischemic heart~     disease. Aim of the present study is to evaluate the effect of heart rate reduction with~     ivabradine, carvedilol or their combination in patients with heart failure of ischemic~     origin.~   "
182311|NCT01178515|"~     Substituting whole milk intake for defatted milk will improve indicators of cardiovascular~     risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density~     Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican~     children 6-13 years of age.~   "
182312|NCT01178502|"~     To develop and validate the predictive warfarin dosing algorithm.~   "
182313|NCT01178489|"~     To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately~     after fast-track hip and knee arthroplasty.~   "
182327|NCT01178307|"~     The goal of this research study is to better understand the symptoms experienced by patients~     with GIST.~      There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews~     and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to~     patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In Part~     3, participants will complete questionnaires about GIST symptoms over 1 year.~      You are being asked to take part in Part 3 of the study.~   "
182314|NCT01178476|"~     Hypoglycaemia is the most common acute complication in insulin-treated diabetes. The fear of~     hypoglycaemia discourages diabetic subjects from the attempt to maintain tight glycemic~     control, which in turn leads to increased diabetes related morbidity and mortality.~      Neuroglycopenic hypoglycaemia in insulin-treated diabetic patients is associated with~     characteristic changes in EEG with a decrease in alpha activity and an increase in delta and~     theta activity. We have recently demonstrated that hypoglycaemia-associated EEG-changes can~     be recorded from subcutaneously placed electrodes using an automated mathematical algorithm~     based on non-linear spectral analysis. Experimental findings hold promises that an alarm,~     given at the time of EEG-changes, can help the patients to avoid severe hypoglycaemia by~     ingestion of carbohydrate.~      This is the first larger scale trial testing the clinical applicability of a~     hypoglycaemia-alarm based on real-time analysis of EEG-signals.~   "
182315|NCT01178463|"~     The researchers hypothesized that nonobstructive azoospermia might be associated with a~     reduction OF SSCs in seminiferous tubules as compared with obstructive azoospermia.~     Testicular sperm specimens that had been previously extracted from azoospermic patients will~     be paraffin embedded and stained with anti GPR-125. After antigen retrieval, the sections~     will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary~     antibodies. Those found to be SSCs will be counted using light microscopy, and compared~     between patients with obstructive (n=11) and non-obstructive azoospermia (n=9).~   "
182316|NCT01178450|"~     The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive~     surgery is superior to cinacalcet for the treatment of persistent secondary~     hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly~     reduces the cost of treatment post transplant.~   "
182317|NCT01178437|"~     The aim of the study is to prove the feasibility and safety of transcutaneous, electrical~     stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.~   "
182318|NCT01178424|"~     Major depressive disorder (MDD) continues to have a profound impact on individuals, families,~     and the health care system. Despite marked success in treating active individual episodes of~     unipolar depression, our understanding of the neural and cognitive mechanisms involved in the~     return of symptoms remains extremely limited, and few interventions exist that specifically~     target factors involved in prophylaxis. The research being proposed is among the first that~     is designed to examine neurocognitive markers for depressive relapse vulnerability and link~     them directly to clinical prognosis.~      Hypothesis 1: Cortical midline structures (CMS) network recruitment will be associated with~     behavioural and neural indices of a reflexive attentional bias towards dysphoric stimuli in a~     divided attention task.~      Hypothesis 2: Behavioural and neural indices of dysphoric attentional bias following mood~     challenge will predict depression relapse in prospective 18-month follow up.~      Hypothesis 3: Relative to CBT, Mindfulness Based Cognitive Therapy (MBCT) will normalize CMS~     and right insular/fronto-opercular cortices (INS-FO) network imbalance.~      Hypothesis 4: Relative to CBT, MBCT will normalize to healthy control levels, behavioural and~     neural indices of dysphoric attentional bias, which will be predictive of reduced relapse~     risk across a 24 month follow up.~   "
182319|NCT01178411|"~     This is an extension study that will allow patients to continue to receive study treatment~     when the original studies into which they were enrolled have reached their designated~     end-dates.~   "
182320|NCT01178398|"~     Many pregnant women in the US do not consume enough docosahexaenoic acid (DHA), an essential~     nutrient found in fish. Apparently conflicting findings that fish consumption is beneficial~     for the developing fetus, yet potentially toxic because of mercury contamination, have~     created uncertainty about the appropriate fish consumption advice to provide pregnant women.~     The investigators objective was to determine knowledge, behaviors, and received advice~     regarding fish consumption among pregnant women who are infrequent consumers of fish.~   "
182321|NCT01178385|"~     Autism spectrum disorders affect as many as 1 out of 150 children and are related to~     significant impairment in social, adaptive, and school functioning. Co-occurring conditions,~     such as anxiety, are common and may cause substantial distress and impairment beyond that~     caused by the autism diagnosis. Although effective interventions have been developed for~     typically developing youth with anxiety disorders, this approach needs to be adapted for~     children with autism. Accordingly, we are proposing a randomized controlled trial to examine~     the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with~     autism spectrum disorders and comorbid anxiety disorder(s).~   "
182322|NCT01178372|"~     Hepatic encephalopathy (HE), a challenging complication of advanced liver disease, occurs in~     approximately 30-45% of patients with cirrhosis. The treatment of choice is non-absorbable~     disaccharides, such as lactulose and lactitol.Probiotics are effective in the treatment of~     minimal hepatic encephalopathy which precipitates hepatic encephalopathy. The investigators~     will assess the effects of lactulose and probiotics for the prevention of recurrence of HE~     (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic~     encephalopathy.~   "
182323|NCT01178359|"~     Despite advances in cardiac arrest resuscitation survival from cardiac arrest is less than~     20-30% and new therapies are urgently needed. Sodium nitrite infused during resuscitation~     from cardiac arrest has recently been shown to improve survival in a mouse model of cardiac~     arrest and our group is eager to test this hypothesis in a clinical trial. Our overall~     hypothesis is that an infusion of 2 μmole/kg sodium nitrite during resuscitation will~     increase the proportion of patients who will survive cardiac arrest. In preparation for a~     clinical trial, preliminary safety and efficacy data (phase 1) is needed which is the primary~     goal of this study.~   "
182324|NCT01178346|"~     The purpose of this study is to look at pharmacoeconomic data for subjects that have received~     either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies.~   "
182325|NCT01178333|"~     HIT-RADIO is a study of patients who had a positive heparin PF-4 antibody test between~     1/21/2008 and 9/25/2008 at selected hospitals. The study will collect and analyse information~     that is already in the patients' medical records. Information about laboratory values (such~     as platelet counts), treatments (such as medications), and outcomes (such as blood clots,~     amputation, and death) will be included.~   "
182328|NCT01178294|"~     This study is to test whether the study drug (OBI-1) is safe and effective for the treatment~     of serious bleeding episodes in people with acquired hemophilia A.~   "
182329|NCT01178281|"~     The objective of this study is to determine whether pomalidomide is safe and effective in~     reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative~     neoplasm (MPN)-associated myelofibrosis. (Global Study) and to describe the frequency of~     anemia response to pomalidomide in Chinese participants with MPN-associated myelofibrosis and~     severe anemia not receiving REC-transfusions (China Extension Study only)~   "
182330|NCT01178268|"~     This is a prospective, randomized, active-controlled, open label, parallel two-arm,~     multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER~     SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) (CYPHER SELECT PLUS) during~     commercial use in China.~   "
182331|NCT01178255|"~     To assess the two components of individualized homeopathic treatment for acute depression,~     i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to~     investigate the effect of different approaches to the homeopathic case history taking(defined~     in this study as case history taking type I and II).~   "
182332|NCT01178242|"~     The purpose of this study is to evaluate salivary gland and labial mucous membrane~     transplantation in patients with severe symblepharon and dry eye secondary to Stevens-Johnson~     Syndrome (SJS).~   "
182333|NCT01178229|"~     Objective: to evaluate the effects of physiotherapy on the anteroposterior airway size in a~     group of bruxist children~      Question: Is a physiotherapeutic technique aiming at changing the head posture, effective to~     increase the anteroposterior dimensions of the upper airway in bruxist children?~      Hypothesis: The bruxist children treated with physiotherapy will present higher airway~     dimensions~      Design: randomized clinical trial with allocation and blinding of the examiners.~      Participants: 3 to 6 year old children with complete primary dentition, dental and skeletal~     class I occlusion. The participants were classified as bruxist according to the minimal~     criteria of the ICSD for bruxism. The children were randomized in an experimental (n=13) and~     a control (n=13) group.~      Intervention: A physiotherapeutic intervention using the Awareness through movement technique~     was applied to the children of the experimental group once a week, until 10 sessions were~     completed.~      Outcome measures: anteroposterior measurements of the nasopharynx, oropharynx and hypopharynx~     taken in a lateral cephalogram with standardized techniques.~   "
182334|NCT01178216|"~     This single center, Phase I/II, exploratory study has been modified to a safety/efficacy~     study providing all patients with IVIG and Rituximab. The trial will examine the safety and~     efficacy of human polyclonal IVIG 10%, when given at [2.0 gm/kgx2], + Rituximab 1gm to reduce~     donor-specific antibodies (DSA) to a level that is permissive for transplantation in 75~     subjects (adults only ages >18 yrs) who are highly-HLA sensitized and are awaiting deceased~     donor kidney transplant. Once transplant offers are entertained, a donor-specific crossmatch~     will be performed. If acceptable crossmatches and DSA levels are seen, the patients will~     proceed to DD transplantation. Patients receiving transplants will receive an additional dose~     of IVIG at transplantation (within 10 days) and will receive additional doses of Rituximab 1g~     at 3M post transplant if DSA levels remain or become positive at 6M if de novo DSA occur.~     Patients who are desensitized and not transplanted at 9M after desensitization will have~     completed the study and can be treated as best judged by their physician.~   "
182335|NCT01178203|"~     Aim: eliminating or reducing pain following endodontic treatment is of great importance. The~     aim of this study is to compare the effects of Tramadol, Novafen and Naproxen on~     post-operative pain following instrumentation of root canals in teeth with irreversible~     pulpitis. Sample size: one hundred patients considering the inclusion and exclusion criteria~     were selected. Intervention and outcome: The effect of Tramadol, Novafen and Naproxen on~     post-operative pain following instrumentation of root canals in teeth with irreversible~     pulpitis was evaluated.~   "
182336|NCT01178190|"~     Narrow band imaging (NBI) videobronchoscopy is an optical technique in which filtered light~     enhances superficial neoplasm based on their neoangiogenic pattern. The objectives of this~     study investigate its better diagnostic yield in the assessment of lung cancer than~     conventional flexible bronchoscopy.~   "
182337|NCT01178177|"~     Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects~     recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced~     neutropenia.Although both of these populations are at high risk for IPA, they differ with~     regards to the specific defects in host defense mechanisms that increase their risk for IPA.~     Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic~     malignancies, whereas transplant recipients tend to have dysfunctional T cells and~     phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related~     infection and inflammation may differ according to the type of underlying immune defect.~     Although the clinical and radiological features of IPA in patients with neutropenia have been~     extensively studied, little is known about the characteristics of IPA in SOT recipients. The~     investigators therefore compared the IPA- related clinical and radiological findings in SOT~     recipients with those of neutropenic patients.~   "
182338|NCT01178164|"~     Fabry disease (FD) is a rare X-linked multisytemic lysosomal disorder caused by~     alpha-galactosidase deficiency. Globotriaosylcéramide (Gb3) deposits are observed in almost~     all tissues examined. Signs of the disease appear earlier and are more severe in affected~     males than in females. Myocardiopathy, renal failure and neurological signs including chronic~     pain and peripheral neuropathies are the most frequent signs. The availability of two~     enzymatic replacement therapies now provides a specific and effective treatment for patients.~     The prevalence of FD is estimated between 1/40,000 and 1/117,000. The frequency of Fabry~     disease has previously been estimated in several series of patients presenting one single~     sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. However, no data~     are available about the prevalence of FD in populations of patients suffering from chronic~     pains of unknown origin.~      The diagnosis of FD will be performed by standard procedures following international~     recommendations. These require the search for a deficiency of alphagalactosidase A activity~     on leucocytes in males and genetic analysis of the GLA gene in females (Lidove et al. 2007).~      The patients in whom the diagnosis of FD is established during this study, will be call in~     for an additional visit in the Investigating Centre in order to confirm the diagnosis and~     propose suitable assessment and care.~   "
182452|NCT01176669|"~     The hypothesis of this clinical research study is to discover if the study drug apatinib can~     shrink or slow the growth of pretreated metastatic triple-negative breast cancer.~   "
182339|NCT01178151|"~     In this pilot study the investigators will treat all patients known with Peutz-Jeghers~     syndrome (PJS) who are diagnosed with advanced malignancies with everolimus 10mg daily until~     disease progression. Most patients with PJS have an inherited LKB1 mutation leading to~     aberrant m-TOR activity. Their risk to develop malignancies or intestinal polyps is probably~     related to this constitutive mTOR signaling. The hypothesis is that mTOR inhibition is an~     effective anticancer treatment in PJS patients with advanced malignancies.~   "
182340|NCT01178138|"~     This protocol will test the safety, effectiveness and the metabolism and action of prazosin~     as a potential therapy for methamphetamine abuse. This will be accomplished by performing a~     series of human laboratory studies. In each of these studies, the safety and effectiveness of~     the test medication (prazosin) in the treatment of methamphetamine effects will be~     determined. The study hypothesis is that prazosin will block the methamphetamine receptor~     function, reducing the reinforcing effects of central nervous system effects in humans.~   "
182341|NCT01178125|"~     This is an open-label, single treatment study. All subjects will receive 12 months of oral~     contraceptive therapy with DR-102. Study participants will receive physical and gynecological~     exams, including Pap smear. During the study, all participants will be required to complete a~     daily diary.~   "
182342|NCT01178112|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of trientine and carboplatin that can be given to patients with advanced cancer.~     The safety of this drug combination will also be studied.~   "
182343|NCT01178099|"~     The purpose of this study is to measure the exposure to prasugrel's active metabolite and the~     pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).~   "
182344|NCT01178086|"~     This observational study will assess the therapeutic efficiency, the treatment schedules and~     handling procedures, and the safety profile of MabThera/Rituxan (rituximab) in routine care~     in patients with chronic lymphocytic leukemia. Data from patients will be collected for a~     total of 24 months.~   "
182345|NCT01178073|"~     The purpose of this study is to compare the two treatment strategies; first-line combination~     therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil)~     in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first~     clinical failure event.~   "
182346|NCT01178060|"~     The goal of this research is to improve communication to Veterans. The investigators want to~     improve how doctors and nurses talk to patients about the risk of heart attack and stroke.~     The investigators will give everyone in the study information about the risk for heart attack~     or stroke. The investigators will also provide information on how to reduce this risk. This~     information will be given in one of two ways. The investigators want to see which way of~     giving information works better for veterans. The investigators also want to assess the~     impact of personalized stroke risk communication to patients at risk for stroke on patient~     knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the impact of~     personalized risk communication on medication adherence and blood pressure. The investigators~     plan to enroll approximately 100 veterans for this study. All veterans will be from the~     Durham VA Primary Care Clinics. The investigators will ask everyone to be in the study for 3~     months.~   "
182347|NCT01178047|"~     Sleep-wake disturbances (SWD) are frequent in Parkinson's disease (PD) and affect the quality~     of life of affected patients.~      Rasagiline is a potent, highly selective, irreversible, second-generation, monoamine oxidase~     type-B (MAO-B) inhibitor with a 24h dopaminergic effect.~      It is well known that dopaminergic treatment closely interacts with SWD. This study aims to~     assess the effect of Rasagiline on SWD in PD patients. In this randomized, double-blind,~     placebo controlled study in clinical phase IV, 60 subjects will be treated with rasagiline~     1mg po once daily or placebo over 8 weeks. The study is planned to be conducted in 6-9 Swiss~     centers. Questionaires will be used to assess SWDs: sleep disturbances (Parkinson's Disease~     Sleep Scale, PDSS), daytime sleepiness (Epworth Sleepiness Scale, ESS), fatigue (Fatigue~     Severity Scale, FSS), apathy (Apathy Evaluation Scale Self, AES-S), disability (Sheehan~     scale) and QoL in PD patients.~        -  Trial with medicinal product~   "
182348|NCT01178034|"~     Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a~     new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR value~     at day five after four days of 5 mg/day warfarin. To this end patients with atrial~     fibrillation starting warfarin are randomized in two arms.~   "
182349|NCT01178021|"~     This is an open label two-arm randomized prospective study of two treatments for P. vivax~     malaria. Patients meeting study inclusion criteria will be enrolled and allocated either~     chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will~     be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients~     with recurrent P. vivax infection will be treated with the same medication as initially~     randomized unless contraindicated. Recurrences in the two arms will be compared to estimate~     the risk of and mean duration to relapse, classify the relapse pattern as early or late~     relapse and to estimate the efficacy and safety of the study drugs.~      Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish~     between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be~     collected on day 7 from each study subject as well as on the day of recurrence if within 8~     weeks of chloroquine~   "
182350|NCT01178008|"~     The proposed study is a randomized controlled trial to examine the efficacy and safety of~     active acupuncture versus placebo acupuncture for the treatment of postpartum depression. The~     investigators hypothesis is that active acupuncture would be superior to placebo acupuncture~     in the short-term treatment of postpartum depression.~   "
182367|NCT01177774|"~     The purpose of this research is to study why most children who have tics never develop~     Tourette syndrome but some do. In other words, we aim to find features that may predict whose~     tics will go away and whose tics will continue or worsen, in children ages 5 through 10 years~     whose first tic occurred within the past 6 months.~   "
182408|NCT01177241|"~     Using a retrospective analysis of a large commercial claims database and a Medicare database,~     the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back~     pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450~     enzyme system, concomitant with other CYP450-metabolized drug(s)~   "
182351|NCT01177995|"~     This study is a randomized outcome trial of a social network HIV prevention intervention for~     at-risk labor migrants who have arrived in St. Petersburg, Russia, to seek work. Most come to~     St. Petersburg from Moldova, Tajikistan, Uzbekistan, Ukraine, and other poor post-Soviet~     republics. While living in Russia, labor migrants are also living in a city and country with~     high HIV prevalence. Many labor migrants have limited awareness of AIDS, and most are living~     in a location far from their spouses, family members, and others. For that reason, labor~     migrants are vulnerable to risk behavior for contracting HIV.~      This study hypothesizes that members of labor migrant social networks whose network leaders~     are trained to deliver HIV prevention messages will exhibit greater reductions in sexual risk~     behavior (unprotected intercourse with nonspousal partners) from baseline to 3- and 12-month~     followup assessments than will members of social networks whose members receive standard,~     individual HIV risk reduction counseling alone.~   "
182352|NCT01177982|"~     Objectives: This project is a Stage II behavioral development study designed to answer~     remaining critical questions necessary before disseminating Reinforcement Based Treatment~     (RBT) to the larger treatment community. These questions focus on the levels of intensity of~     RBT most efficacious for substance-using pregnant patients. Design: The proposed study~     utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple~     assignment randomized trial (SMART) design. Participants (N=220) will first be randomized at~     treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All~     participants will receive a subsequent randomization based upon an assessment of their~     initial two weeks of treatment compliance. Early-non-compliant participants will be~     randomized to receive either the same or an increased level of RBT treatment intensity while~     early-compliant participants will be randomized to receive either the same or decreased level~     of treatment intensity and scope. Primary outcome measures include treatment completion, and~     maternal heroin, cocaine, and other illicit substance use. Secondary outcome measures include~     maternal measures of HIV risk behavior, and psychosocial functioning and neonatal measures of~     length of hospitalization, and birth outcomes. Significance: The proposed project's~     innovation includes: the novelty RBT, use of a cutting-edge SMART model, application of~     advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed~     project's significance is exceedingly high, as it will lay the foundation for later Stage III~     studies focused on dissemination of stepped care treatment programs for drug-addicted~     pregnant women that can be implemented not only in comprehensive care clinics but in diverse~     community settings that provide services to such women.~   "
182353|NCT01177969|"~     Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders,~     causing substantial distress and impairment over and above the autism spectrum diagnosis~     alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically~     developing youth with an anxiety disorder and when adapted, shows promise in children with~     ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to~     meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid~     anxiety. Given this, the present study seeks to develop and test a new CBT therapy in~     adolescents with autism and comorbid anxiety.~   "
182354|NCT01177956|"~     The primary objective of this trial is to assess the antitumor activity and safety profile of~     cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line~     treatment of recurrent and/or metastatic Squamous Cell Carcinoma in Head and Neck (SCCHN) in~     Asian subjects.~   "
182355|NCT01177943|"~     To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4~     milligrams per milliliter [mg/mL]) compared with 2 capsules of atomoxetine (25 mg per~     capsule) in healthy adult male Japanese subjects.~   "
182356|NCT01177930|"~     The purpose of this study is to evaluate the influence of the type of feeding in the first~     year of life on the behavior and health-related quality of life at 6-8 years of age.~   "
182357|NCT01177917|"~     This clinical trial will help determine if prebiotics can increase mineral absorption in~     babies~   "
182358|NCT01177904|"~     There seems to be a general consensus on the supplementation of progesterone (P4) for luteal~     phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there~     is no agreement about the precise duration of LPS.~   "
182359|NCT01177891|"~     The Premature ovarian failure (POF) is a rare syndrome observed in women under 40 who induced~     estrogen deficiency and often leads to infertility final. The etiologies of POF remain~     unknown in more than 85% of cases. There are 5-10 % of familial cases.The main objective of~     this study is to recruit, phenotype and genotype 20 families with at least two subjects with~     nonsyndromic POF in order to identify new loci using a single technical standard nucleotide~     polymorphisms (SNPs). This study will also include related population and population control.~   "
182360|NCT01177865|"~     RATIONALE: Gathering information about patients with prostate cancer may help doctors learn~     more about how patients choose treatment options.~      PURPOSE: This study is looking at treatment choice in patients with localized prostate~     cancer.~   "
182361|NCT01177852|"~     Multicenter clinical trial, phase III, controlled by active medicine, open, randomized,~     enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway~     characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no~     more than 5 consecutive days (without systemic/topic use of medication during this period)~     followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny~     nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel~     groups, and will receive the medicines of study, according of the randomization.~   "
182362|NCT01177839|"~     This prospective study aims to estimate the incidence of intussusception among children < 2~     years old through hospital-based surveillance in Singapore.~   "
182363|NCT01177826|"~     The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing~     rotavirus severe gastroenteritis among hospitalized infants, in Belgium.~   "
182364|NCT01177813|"~     The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773~     compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM~     with insufficient glycaemic control. For the open-label part of the study the objective is to~     estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM~     with very poor glycaemic control.~   "
182365|NCT01177800|"~     The purpose of this study is to determine the superiority and efficacy of infliximab~     induction therapy in chinese participants with moderate to severe plaque-type psoriasis~     (scaly skin rash) compared with placebo (an inactive substance that is compared with a drug~     to test whether the drug has a real effect in a clinical trial).~   "
182366|NCT01177787|"~     The aim of this study is to evaluate the clinical efficacy of reduction of local fat on~     ipsilateral thigh through cryolipolysis (zeltiq) and controlateral thigh using by amplitude~     modulated frequency (conventional) method.~   "
182368|NCT01177761|"~     The study determines the long-term effect of exercise on osteoporotic fracture risk. Since~     actually no controlled supervised exercise study exceeds the time frame of 4 years, knowledge~     concerning the long-term effect of exercise on fractures and fracture-risk factors is scarce.~     Within the Erlanger Fitness and Osteoporosis Study (EFOPS, an ongoing controlled exercise~     study with currently 16 years of supervised exercise with 45-50 osteopenic,~     early-postmenopausal women in exercise and sedentary control group each, the investigators~     therefore focus on overall-fractures, Bone Mineral Density and falls.~   "
182369|NCT01177748|"~     Cardiac arrhythmia are frequently observed after stroke. They may on one hand be causative~     for the stroke mainly in case of atrial fibrillation but on the other hand present severe~     complications of the stroke. In addition, cardiac comorbidity as well as acute myocardial~     infarction are frequently found in acute stroke patients. Diagnostics to identify cardiac~     arrhythmia in the acute phase of stroke care thus have an important role not only for~     adjusting the correct secondary prevention but also to prevent cardiac complications~     potentially reducing morbidity and mortality.~      The aim of the SAMBA-Study is to systematically assess the prevalence of higher grade~     arrhythmias after stroke using a standardized reading of 72h telemetric monitoring in the~     first days after stroke onset. In addition, it evaluates different strategies to identify~     paroxysmal atrial fibrillation.~   "
182370|NCT01177735|"~     This is a phase II study, open-label, single institution trial of pomalidomide in~     GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have~     included lenalidomide. Patient accrual is 30 over a 2 year period.~      Primary objective:~        -  To determine progression-free survival (PFS) after initiation of pomalidomide therapy~      Secondary objective:~        -  To determine the response rate (CR, n-CR, VGPR) and duration of response after~          pomalidomide therapy.~        -  To determine gene expression profiling (GEP) changes exerted within 48 hours of~          initiation of daily pomalidomide dosing.~        -  To determine gene expression profiling (GEP) changes exerted within 48 hours of~          initiation 3 concurrent days of exposure to lenalidomide.~        -  To determine MRI- and PET-CT-defined CR in studies obtained at baseline and every 6~          month examinations.~   "
182371|NCT01177722|"~     The purpose of this study is to generate immunogenicity and safety data of an investigational~     hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when~     given along with Prevenar™ and Rotarix™ vaccines.~      Primary Objectives:~        -  To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T~          vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with~          Prevenar™ and Rotarix™, in terms of immunoresponses.~        -  To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the~          licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.~      Secondary Objectives:~        -  To describe in each group the immunogenicity parameters for all antigens for each~          vaccine~        -  To assess the safety profile in terms of solicited and unsolicited adverse events and~          serious adverse events in each group for each vaccine.~   "
182372|NCT01177709|"~     Study hypothesis is that patients on antipsychotics medication treated with metformin will~     show loss in weight and improved measures of glucose metabolism.~   "
182373|NCT01177696|"~     Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of~     sanitary problems in adults with chronic diseases, they usually have a lack of experience in~     development of psychotherapeutic interventions. However, these interventions are the ones~     that achieve better results to reduce symptomatology and improve emotional state of~     caregivers.~      The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving~     the mental health and quality of life of caregivers. This intervention is based on~     theoretical approaches to care adjusted to cognitive theory, in order to be applied in~     primary health care centres.~      To assess a cognitive-behavioural intervention to modify dysfunctional thoughts to properly~     face the care.~   "
182374|NCT01177683|"~     This is an open label phase I/II trial to determine the safety and the biologic activity of~     the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.~   "
182375|NCT01177670|"~     The Adiana Post-Approval Clinical Study (APACS) has been designed to compile information on~     the efficacy and safety of the Adiana Permanent Contraception System in the post market~     setting. Specifically, data will be collected that is relevant to the evaluation of the~     safety and efficacy of the Adiana System for women who desire permanent birth control by~     occlusion of the fallopian tubes. This study is an observational study that is not intended~     to test specific hypotheses.~   "
182376|NCT01177657|"~     The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination~     in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area,~     Brazil.~   "
182377|NCT01177644|"~     This study will evaluate the safety and preliminary effectiveness of PDS 1.0 in patients with~     neovascular AMD.~   "
182378|NCT01177631|"~     This is a pilot study to evaluate the difference between the protein expression between~     hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular~     carcinoma.~   "
182379|NCT01177618|"~     Chronic obstructive pulmonary disease (COPD) is often caused by cigarette smoking, but~     genetic predisposition also influences COPD susceptibility. The purpose of this study is to~     identify genetic factors that predispose some individuals to develop COPD.~   "
182380|NCT01177605|"~     This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness,~     stool patterns and growth of two cow's milk-based beverages for children.~   "
182388|NCT01177501|"~     The early relapse of ovarian cancer occurring within 6 months of chemotherapy including~     platinum regimen are called relapses 'platinum resistant' consecutively patients die quickly~     of their disease. For relapses occurring between 6 and 12 months, no recommendation occur and~     few studies are conducted. Therefore it seems interesting to develop a research on intensive~     chemotherapy using a combination of carboplatin (a drug widely used in most ovarian cancer)~     with Topotecan , use in a high dose protocol. Topotecan has demonstrated its efficacy in~     relapse ovarian cancer and its possible use in high doses, a recent study (ITOV01) have~     demonstrated the feasibility of dose escalation of topotecan monotherapy (MTD set at 9 mg /~     m² / dx 5 days). This project is a feasibility research of the combination of topotecan and~     carboplatin in a high dose escalation protocol for early ovarian cancer relapse occurring 6~     to 12 months after conventional chemotherapy-based platinum salts.~   "
182381|NCT01177592|"~     This is a prospective, single-center, randomized trial including 1500 subjects requiring PCI.~     Subjects with ischemic heart disease due to stenotic lesions in either native coronary~     arteries or coronary artery bypass undergoing PCI with stent placement and no~     contraindication to prolonged dual antiplatelet therapy (≥1 year) are eligible to be in the~     study. Subjects will be randomized to either guided antiplatelet therapy arm (n=750) or~     standard therapy arm (n=750) and undergo laboratory testing, antiplatelet adjustment, and~     clinical follow-up for 1 year.~      Patients (non-emergent) presenting for PCI will receive standard pre-procedural PCI care as~     outlined by the current ACC/AHA guidelines. Subjects will be consented peri- PCI (prior to or~     within 24 hours of PCI) and then randomized (1:1 ratio) to guide or standard non-guided~     (control) antiplatelet therapy. Physicians will be blinded to genotyping and platelet~     function results for subjects randomized to the standard therapy group for the duration of~     the study or if endpoint is met. Subjects on chronic clopidogrel or prasugrel therapy (≥ 2~     weeks) will be guided by VerifyNow P2Y12 assay, whereas clopidogrel naïve subjects will be~     guided by Verigene CYP2C19 genotyping assay. Patients on clopidogrel maintenance and/or in~     the control group will also be genotyped; conversely, clopidogrel naïve subjects will have~     VerifyNow testing prior to discharge for additional study analysis. Patients in the guided~     therapy group that have a measurement of ≥ 230 PRU will be reloaded with 60mg prasugrel and~     receive standard maintenance dosing. Similarly, clopidogrel naïve subjects that are~     considered CYP2C19*2 carriers will also be reloaded with 60mg prasugrel and receive standard~     maintenance dosing (see flow schematic). Patients randomized to the control arm will remain~     on 75mg clopidogrel arm throughout the study. All patients will remain on 325mg ASA for one~     month and 81-162 mg daily ASA thereafter.~      Clinical follow-up (office visit) and post-PCI VerifyNow maintenance testing will occur at 2~     weeks, 3 months, and 6 months for patients in the guided therapy group. VerifyNow testing,~     adverse event occurrence and drug compliance will be performed as part of follow-up. Patients~     having a measurement of ≥ 230 PRU at 2 weeks or the 3 month visit will be reloaded with 60 mg~     prasugrel and receive standard maintenance dosing thereafter until the 6-month visit.~     Patients in guided and control study arms will return at 6 months for clinical follow-up and~     VerifyNow testing. After completing 6 months of the study treatment period, further~     antiplatelet therapy will be at the physician's discretion. At 1 year, study subjects will be~     contacted via phone for clinical assessment and antiplatelet compliance. Physicians~     adjudicating events will be blinded to the therapy assignment.~   "
182382|NCT01177579|"~     Copper is an essential nutrient for humans and is cofactor in enzymes that participate in~     critical body functions. Insufficient copper can lead to hematological and neurological~     abnormalities that may be irreversible if left untreated. Copper deficiency is believed to be~     rare in the U.S. population because typical dietary intake is usually sufficient to meet~     requirements. More recent evidence suggests that specific populations may be susceptible to~     copper deficiency in cases where copper absorption in the gut is impaired following gastric~     surgery or in individuals with high intakes of zinc. Preliminary studies by us and others~     have identified significant levels of moderate and severe symptomatic copper deficiency in~     patients who have undergone weight loss (bariatric) gastric bypass surgery. Copper deficiency~     in humans is difficult to recognize and treat because current diagnostic tools rely on~     measures of plasma concentrations of copper and ceruloplasmin, which are neither sensitive~     nor specific for copper deficiency, and early warning blood markers (biomarkers) have not~     been identified. Recent developments indicate that copper chaperone molecules and~     cuproenzymes such as cytochrome C oxidase and superoxide dismutase may be more sensitive to~     changes in copper status, but there has been very little work done in humans. The studies~     outlined here are aimed at assessing copper status using these biomarkers in gastric bypass~     surgery patients who are at risk for symptomatic copper deficiency. In addition, patients~     identified to be deficient will be supplemented with copper and this treatment will be~     evaluated using biomarker concentrations. The findings of these studies should provide~     insight into the effectiveness of novel biomarkers to identify those at risk and to guide~     appropriate treatment to prevent serious and permanent morbidity due to copper deficiency.~   "
182383|NCT01177566|"~     The purpose of this study is to assess a bilateral comparison between pimecrolimus cream 1%~     (Elidel®) and a medical device cream (EletoneTM) in the treatment and management of atopic~     dermatitis. Study subjects will apply pimecrolimus twice daily for four weeks on a target~     area located on one side of the body, and apply the medical device cream three times daily~     for four weeks on the opposite side of the body at a target lesion symmetric to the other.~   "
182384|NCT01177553|"~     Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton~     pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic~     twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous demise~     of the SIUGR twin can occur, and may result in concomitant demise (up to 40% risk) or severe~     neurologic handicap (up to 30% risk) of the other twin. These complications result from~     exsanguination of the appropriately grown (AGA) twin into the demised SIUGR twin through~     placental vascular communications.~      Because the adverse effects to the AGA twin of the spontaneous demise of the SIUGR twin are~     mediated through placental vascular anastomoses, we have proposed obliterating such~     anastomoses via endoscopic fetal surgery. We have developed a technique that allows us to~     identify the vascular anastomoses present in monochorionic placentas. Briefly, deep AV~     communications are identified on the surface of the placenta by noting that the terminal end~     of the artery of one of the fetuses does not have a corresponding returning vein to the same~     fetus. We have speculated that the separation of the circulations may be of benefit in~     monochorionic twins affected by SIUGR by preventing the adverse effects that may result from~     the spontaneous demise of the IUGR twin. Our goal is to evaluate with a randomized clinical~     trial the outcome of SIUGR managed either expectantly or with SLPCV.~      Study procedures will begin with confirmation of the diagnosis and screening criteria at the~     Qualified Clinical Center. The patient will sign the appropriate consents and then be~     randomized to her treatment group. Enrollment data will be submitted to the research~     coordinator in Coordinating Center in Tampa. Expectant management patients will be treated by~     the referring physicians. Laser patients will be treated at Coordinating Center in Tampa~     General Hospital or qualified laser center. They may return to the referring center for~     follow-up. After delivery, outcome data will be sent to the research coordinator in~     Coordinating Center in Tampa.~   "
182385|NCT01177540|"~     The purpose of this study is to provide data on the activity of a standard daunorubicin,~     cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed~     by standard measures of complete remission (CR), leukemia free survival (LFS) and overall~     survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary~     data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is~     currently unavailable.~   "
182386|NCT01177527|"~     The purpose of this study is to obtain bone marrow and peripheral blood samples, along with~     clinical data from patients with Multiple Myeloma (MM), Waldenstrom's Macroglobulinemia (WM),~     Smoldering MM, and other lymphoplasmacytic lymphomas (LPL) including but not limited to MGUS~     and IgG or IgA LPL. These samples will become part of a tissue bank and will be used in~     ongoing studies to find out more about the causes and biology of MM, WM and LPL; to identify~     what factors result in normal cells becoming cancer; to determine how to improve treatment~     options; to study how the immune system identifies abnormal cells; and to evaluate the immune~     function in these diseases. The investigators will also study the tumor cells at the level of~     the participant's genes to develop treatment strategies as well as to better understand how~     biologic differences affect patient outcomes.~   "
182387|NCT01177514|"~     The primary aims of this study are to determine if treatment with Gabapentin taken~     systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical~     treatments reduces post surgical neuropathic pain and discomfort. The investigators main~     Hypothesis is that gabapentin given prior to and after refractive surgery prevents central~     sensitization and local allodynia.~   "
182389|NCT01177488|"~     The purpose of this study is to determine whether therapy for Operation Iraqi~     Freedom/Operation Enduring Freedom (OIF/OEF) veterans with Post-traumatic Stress Disorder~     (PTSD) symptoms can be delivered effectively using videoconferencing technology~     (telepsychology), which allows a therapist and patient who are not in the same room as one~     another to communicate.~   "
182390|NCT01177475|"~     It seems important to correlate real consumption in bioactives molecules of natural milk~     versus pasteurized with gut maturation in very preterm infants during small enteral feeding~     protocol. This objective will be reached through a clinical trial.~   "
182409|NCT01177228|"~     The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics~     (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative~     colitis (UC).~   "
182391|NCT01177462|"~     Manipulation of object is a multisensory experience that includes tactile motion between the~     object and the fingerpad, visual motion elicited by the motion the object and the movement of~     the hand, and the active motor commend to control upper limb and hand conformation. It~     remains to be determined how such a complex interaction between touch and vision could be~     achieved effortlessly. In the present study, we will investigate how the motion information~     is transformed between touch and vision using the most novel approaches in human~     psychophysics, neuropsychology and monkey neurophysiology. Specifically, we will present~     tactile motion on primate fingerpads using a recently developed ball stimulator with a design~     in which we vary the direction of motion with respect to the skin surface and also vary the~     hand conformation and position. This setup allows us to systematically sample the possible~     scenarios involving coordinate transformation between the somatosensory and visual systems in~     conditions that could occur in hand exploration and object manipulation in daily life. We~     will present these tactile stimuli on normal human subject as well as stroke patients such as~     patients with spatial hemineglect. Finally, we will record from macaque monkeys in cortical~     areas that are thought to underlie the transformation of coordinates, such as the primary~     somatosensory cortex and posterior parietal cortex. The results of the present study will~     contribute to the understanding of multisensory integration and the rehabilitation for~     patients with impaired use of spatial information.~   "
182392|NCT01177449|"~     The purpose of this study is to investigate the effect of prolotherapy on balance and lumbar~     flexibility in the patients with a sacralized L5 vertebra. Evaluations for ability on balance~     include sensory organization test (SOT,) rhythmic weight shifting (RWS) and limits of~     stability (LOS.)~   "
182393|NCT01177436|"~     Nowadays, prostate cancer screening is largely widespread although it is not recommended yet.~     This screening includes primarily digital rectal examination and PSA.~      Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3~     gene.~      The main objective is to evaluate prospectively this new marker in patients treated for~     prostatic pathology (benign or malign) in the department.~   "
182394|NCT01177423|"~     Management of dental pain emergencies is a challenge for the clinician, particularly when~     pain is due to endodontic infection.~      Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior~     alveolar nerve block for mandibular molars anesthesia.~      The aim of the study is the evaluation of Quicksleeper efficiency used in first intention~     versus inferior alveolar nerve block used in most current dental treatment.~   "
182395|NCT01177410|"~     The purpose of this study is to determine the daily dose of mesalamine granules that will~     provide adequate relief from symptoms of IBS with diarrhea.~   "
182396|NCT01177397|"~     The main purpose of this first human study with CC-223 is to assess the safety and action of~     a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors~     unresponsive to standard therapies and to determine the appropriate dose and tumor type for~     later-stage clinical trials.~   "
182397|NCT01177384|"~     This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C)~     more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a~     steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg~     once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM~     with inadequate glycemic control on acarbose monotherapy.~   "
182398|NCT01177371|"~     RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide,~     before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop~     the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted~     cells from a donor can make an immune response against the body's normal cells. Giving~     cyclosporine, methylprednisolone, and methotrexate after transplant may stop this from~     happening.~      PURPOSE: This clinical trial studies high-dose busulfan and high-dose cyclophosphamide~     followed by donor bone marrow transplant in treating patients with leukemia, myelodysplastic~     syndrome, multiple myeloma, or recurrent Hodgkin or Non-Hodgkin lymphoma.~   "
182399|NCT01177358|"~     The investigators hypothesize that Botox A will reduce scarring and improve healing of~     surgical neck wounds.~   "
182400|NCT01177345|"~     Cervical cancer screening is a worldwide problem especially in the developing world of which~     Tanzania belongs. It is diagnosed late in the third world because there are no diagnostic~     facilities and resource people. It occurs in the age groups between 40 and above and~     therefore affects the productive age of the community. It is well known that women generally~     are the backbone of every community and specifically in the developing countries.~      The objective of this research is to analyze and quantify the burden of cervical cancer~     disease in the community. It will research the interpersonal and socioeconomic issues~     associated with cervical cancer disease in the family.~   "
182401|NCT01177332|"~     There is increasing evidence that hepatic lipid content (IntraHepatic Lipid, IHL) markedly~     increases the risk of metabolic complications, including insulin resistance and~     cardiovascular events. The investigators hypothesize that the liver is passively taking up~     free fatty acids (FFA) when the availability is high, thereby leading to an increased~     storage. To test this hypothesis, the investigators want to manipulate FFA levels, by means~     of a fasted exercise and recovery protocol, and monitor IHL content and hepatic Adenosine~     triphosphate (ATP) and inorganic phosphate (Pi) concentrations.~   "
182402|NCT01177319|"~     This is an investigator initiated pilot study to examine the effects of GSH in PD. The goal~     of this study is to acquire some basic data regarding side effects and efficacy of this~     compound to determine if this is a possible treatment option that could be recommended to~     interested PD patients.~   "
182403|NCT01177306|"~     Minimum 24 subjects aged 8-12 with a diagnosis of ADHD will be prescribed extended release~     guanfacine (Intuniv) to assess impact, if any, on working memory. Pre and post testing using~     a standardized battery of tests for effect on symptoms of ADHD and working memory will be~     administered and assessed.~   "
182404|NCT01177293|"~     This study is being performed to determine the bioavailability, or extent of absorption into~     the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to~     the bioavailability of a 10 mg amlodipine besylate capsule.~   "
182413|NCT01177176|"~     Cigarette smoking is the leading preventable cause of death in the U.S. Nearly 4 million U.S.~     smokers are hospitalized each year, many of them at high risk for tobacco-related disease or~     death. A hospital admission provides an opportunity for a smoker to quit. Smoking cessation~     counseling provided in the hospital is effective, but only if it continues for >1 month after~     discharge. Smoking cessation medications add benefit to counseling but are not often used.~     The challenge is to translate this efficacy research into routine clinical practice. The~     major barrier is to make the transition from inpatient to outpatient care. An evidence-based,~     cost-effective intervention model that can be adopted by U.S. hospitals is needed to realize~     the potential impact of hospital smoking interventions.~      The Specific Aim of this project is to conduct a randomized controlled comparative~     effectiveness trial of two strategies to promote smoking cessation in hospitalized patients:~     (1) a hospital-only intervention that meets the current standard of the National Hospital~     Quality Measures(Standard Care), and (2) an Extended Care Management model with 2~     components that aims to encourage and facilitate the sustained use of smoking cessation~     treatment (counseling and medication use) after discharge in order to achieve long-term~     abstinence. It adds to Standard Care 3 months of telephone-based contact after discharge and~     feature 2 innovations: (1) to increase medication use, smokers willing to make a quit attempt~     receive a free, refillable 30-day sample of their choice of FDA-approved smoking cessation~     medication at hospital discharge; (2) to increase counseling cost-effectiveness, interactive~     voice recognition (IVR) technology is used to make automated telephone calls to identify the~     smokers interested in or most likely to benefit from continued counseling after discharge.~     The trial will enroll 330 adult smokers admitted to Massachusetts General Hospital, a 900-bed~     teaching hospital. Outcomes will be measured 1,3 and 6 months after hospital discharge. Study~     hypotheses are that the enhanced care arm, compared to usual care, is feasible and will~     increase (1) the use of smoking cessation treatment after discharge, (2) the duration of~     post-discharge tobacco abstinence, and (3) validated tobacco abstinence 6 months after~     hospital discharge (primary outcome). The principal secondary outcome measure is~     self-reported 7-day point prevalence tobacco abstinence after hospital discharge. Other~     secondary endpoints include self-reported point prevalence abstinence at 1 and 3 months,~     prolonged abstinence (self-reported tobacco abstinence at 1, 3, and 6 months). The~     cost-effectiveness (cost per quit) of the interventions will be also be compared.~   "
182414|NCT01177163|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacodynamic effects~     and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with~     Type 2 Diabetes Mellitus who are on a stable dose of insulin.~   "
182415|NCT01177150|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and~     or the pharmacodynamics (PD) of single oral doses of JNJ-28431754 in healthy male volunteers.~     The study will evaluate the PK and PD effects of study drug in volunteers who fasted compared~     to those who did not fast before study drug administration.~   "
182416|NCT01177137|"~     The primary purpose of the Tinnitus Retraining Therapy Trial (TRTT) is to assess the efficacy~     of tinnitus retraining therapy (TRT) as a treatment for severe debilitating tinnitus. TRT is~     a non-medical intervention that uses directive counseling (DC) and sound therapy (ST)to~     habituate the patient's associated negative emotional reactions to tinnitus, its perception,~     and ultimately, its impact on the patient's life.~   "
182417|NCT01177124|"~     The purpose of this study among breast cancer survivors is three-fold: (i) to evaluate the~     efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of~     life and measures of immune function and a stress hormone (cortisol); (ii) to test whether~     positive effects achieved from the MBSR(BC) program are mediated through changes in~     mindfulness and fear of recurrence of breast cancer; and (iii) to evaluate whether positive~     effects achieved from the MBSR(BC) program are modified by specific patient characteristics~     measured at baseline.~   "
182418|NCT01177111|"~     Each year four million babies die during the neonatal period, with the majority occurring in~     developing countries. Overall, infections account for one-third of all neonatal deaths, with~     proportions approaching 50% in settings where neonatal mortality rates are high. Infections~     are predominately due to sepsis, respiratory infections, tetanus, and diarrhea. The~     investigators long term goal is to identify simple, affordable, and effective interventions~     that can be delivered at the community level in low-resource settings to reduce neonatal~     mortality risk due to these infections. The investigators team has conducted research in this~     area for the past 10 years, with specific focus on newborn vitamin A dosing and topical~     chlorhexidine antisepsis interventions. Previous community-based research by the~     investigators group of investigators and others demonstrated that newborn vitamin A dosing~     can reduce early infant mortality by approximately 20%, and that topical applications of~     chlorhexidine to the umbilical cord can prevent omphalitis and reduce neonatal mortality risk~     by 24%. Evidence is growing that neonatal skin plays an important role in protecting the~     newborn infant from invasive pathogens. Barrier function of the neonatal skin, however, is~     incomplete in newborn infants, especially those that are pre-term or of low birth weight.~     Full-body massage of newborns with mustard oil, practiced almost universally (~95%) in~     communities of south Asia, may further compromise skin barrier function through decreased~     structural integrity leading to increased trans-epidermal water loss and increased risk of~     percutaneous penetration by invasive pathogens. Loss of structural integrity is not seen~     after massage of neonatal skin with alternative topical emollients, including sunflower seed~     oil. Furthermore, sunflower seed oil has been shown to accelerate recovery of the skin~     barrier function, improve skin condition, and reduce the risk of both nosocomial infections~     and neonatal mortality among hospitalized newborns in low-resource settings. The specific~     hypothesis of this study is that substituting mustard oil with sunflower seed oil for topical~     applications during full body massage of newborns in the community will reduce neonatal~     mortality and morbidity by improving overall skin barrier function and reducing exposure to~     invasive pathogens.~   "
182419|NCT01177098|"~     This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A~     ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once~     daily for 12 weeks in patients with glaucoma or ocular hypertension.~   "
182420|NCT01177085|"~     This is a one-year clinical trial to assess weight-loss, weight-maintenance, and biochemical~     parameters following a weight-control diet using either standard food guide pyramid alone, or~     standard food guide pyramid with substitution of mushrooms for meat.~   "
182421|NCT01177072|"~     1. That the psychotherapeutic intervention - Components-Base Interventions (CBI) - is~          effective in reducing the severity of mental health symptoms experienced by torture~          survivors in Southern Iraq.~        2. That the psychotherapeutic intervention - Cognitive Processing Therapy (CPT) - is~          effective in reducing the severity of mental health symptoms experienced by torture~          survivors in Southern Iraq.~   "
182422|NCT01177059|"~     The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency~     Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1~     Ribozyme [OZ1]) as part of an earlier phase 2 trial. Patients are seen twice yearly until 5~     years from initial infusion of study drug has elapsed and then yearly until withdrawal or~     study completion. The study will monitor for and record any ill effects from the gene therapy~     product to provide long term safety information.~   "
182423|NCT01177046|"~     The findings of this research will be used to develop a scale for measuring the quality of~     epidural pain relief achieved during labour and vaginal delivery.~   "
182453|NCT01176656|"~     The purpose of this study is to assess the burden of hypoglycemia and identify unmet need~     related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on~     OADs and/or insulin. This is an observational study which will identify patients with T2DM in~     an administrative claims database and will link claims data with results of patient and~     physician surveys concerning hypoglycemia.~   "
182454|NCT01176643|"~     The purpose of this study is to test the effects of a modified yoga program in persons with~     SLE.~   "
182424|NCT01177033|"~     CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS~      Phase: IV~      TITLE OF STUDY~      Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised~     controlled trial for patients with complex lesions of the superficial femoral artery~      CONDITION~      Peripheral arterial occlusive disease (PAOD)~      OBJECTIVE(S)~      The objective of this study is to evaluate the safety and efficacy of two therapeutic~     strategies (operative versus endovascular) in the treatment of patients with complex~     atherosclerotic lesions of the superficial femoral artery.~      INTERVENTIONS~      Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention~     type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein~     (1° choice) or a prosthetic graft (if vein is not available).~      Duration of intervention per patient: Dependent on the method of treatment~      Follow-up per patient: 24 months~      OUTCOMES~      Primary efficacy endpoint:~      Two primary efficacy endpoints will be considered simultaneously in this trial:~      (A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of~     surviving patients who show a continuing clinical improvement of >= 1 class (Rutherford~     classification) without the need for repeated target lesion revascularization (TLR).~      (B) Proportion of surviving patients with clinical improvement of >= 1 class (Rutherford~     classification) at 24 months after primary intervention (regardless any performed~     re-intervention).~   "
182425|NCT01177020|"~     Identification of the presence of proangiogenic immune cells in normal human placentas may~     enable predication of some pregnancy disorders.~   "
182426|NCT01177007|"~     This study is an open label prospective trial of TheraSphere treatment for patients who have~     liver metastases who have failed or are intolerant to other systemic or liver directed~     therapies. Patients will be treated with TheraSphere at doses of 120 ± 10% Gy, and then~     followed for time to progression (TTP), safety, and overall survival.~   "
182427|NCT01176994|"~     Existing methods of diagnosing and treating skin lesions are either surgical, which enables~     an histological diagnosis or destructive (electrodesiccation, liquid nitrogen, laser,~     caustics) with no possibility of obtaining histology. The ingredients of current formulations~     for in-vivo skin fixation (Mohs, Solcoderm) are unstable, inconvenient for application and~     painful - therefore their use was abandoned. The investigators will examine the safety of~     stable formalin-free formulations for in-vivo fixation of human skin lesions .These~     formulations were safe and had a rapid onset of fixation effect in in-vivo animal studies.~   "
182428|NCT01176981|"~     The primary purpose of this study is to determine the safety and feasibility of delivering~     HDMTX in an outpatient setting.~   "
182429|NCT01176968|"~     Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction,~     in patients without heart failure, reduces cardiovascular mortality / morbidity.~   "
182430|NCT01176955|"~     This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with~     mild to moderate acne. Study subjects will be randomized to an internet survey group, in~     which an email link for a survey ascertaining the status of the subject's acne is sent~     weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and~     adherence and clinical improvement will be monitored over 12 weeks. The investigators~     hypothesis is that subjects in the internet survey group will have improved adherence to the~     study medication and clinical outcomes, because the weekly survey will remind subjects to use~     their medication.~   "
182431|NCT01176942|"~     The purpose of this study is to determine whether probiotic treatment of overweight~     volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide concentration.~   "
182432|NCT01176929|"~     The prevention of recurrent suicidal about people who have made a suicide attempt is a major~     strand in the prevention of suicide. It is estimated that 10-15 % of people who made a~     suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the~     subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at~     one year. Most people who made a suicide attempt receive ambulatory monitoring. On this~     population, there is a low adherence to care.~      The main objective of the study is to test the effectiveness of a prevention program of~     recurrent suicidal acts for people who made a suicide attempt.~      The secondary objectives of this study are the assessment of adherence to care; the~     identification of sub - populations benefiting most from this program; the evaluation of the~     possible generalization level of the program (eligibles persons rate) and its feasibility~     level.~   "
182433|NCT01176916|"~     Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women~     with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years~     of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of~     adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial~     waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since~     then, there is currently lack of systematic collection and analysis for the efficacy and~     safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin®~     Non-Interventional Study is being proposed to collect data systematically and to assess the~     efficacy and safety of Aromasin® adjuvant setting in Chinese population.~   "
182434|NCT01176903|"~     The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as~     pMDI after single and repeated administration.~   "
182435|NCT01176890|"~     The aim of this study is to investigate the role of transmission via the vagal nerve for the~     effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food~     intake.~      The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous~     system and for this reason the researchers will investigate individuals with and without~     intact nervous supply.~   "
182436|NCT01176877|"~     The purpose of this study is:~        -  to identify how knowledge about keloid scars and self-treatments differs between~          patients who use the Internet as a source of information and patients who do not~        -  to determine if patients who are at a high risk of developing additional keloid scars~          are more or less likely to change their behavior based on an educational information~          talk about keloid scar prevention~   "
182437|NCT01176864|"~     Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic~     small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the~     technique. A prospective randomized study was carried out to compare the two methods in~     obscure small bowel bleeding~   "
182439|NCT01176838|"~     The purpose of this study is to provide the physicians with quality long term follow up data~     on subjects from the Breast Cancer Clinic and the Plastic Surgery Clinic who have been newly~     diagnosed with breast cancer and will receive treatment for the cancer at this facility. Over~     the last two decades many studies have been done concerning the quality of life after a~     mastectomy and/or reconstruction process. The majority of these studies only run for one year~     post reconstruction, some however, do include a two year follow up. The investigators are~     proposing a 5 year long term follow up study on subjects who will be diagnosed and treated~     here at the Breast Cancer Clinic and the Plastic Surgery Clinic. The investigators first~     questionnaire will be given prior to any treatment for breast cancer, giving us a baseline~     for the subject's current quality of life. At each successive year, the subject will be given~     another questionnaire with regards to their progression through the reconstructive process.~     At the end of 5 years, the subject will complete a final questionnaire. These questionnaires~     will deal with many areas of daily life functions; activities of daily living, anxiety,~     depression, social interactions, personal and sexual relationships.~   "
182440|NCT01176825|"~     The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention~     for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on~     improving management of bipolar disorder, reducing involvement in high-risk behaviors, and~     enhancing psychosocial functioning. The intervention also focuses on issues specific to~     transition-age youth. The study includes two phases: In phase 1, the intervention will be~     developed, refined, and openly piloted with several participants. In phase 2,the~     investigators will conduct a randomized clinical trial, in which 40 participants will be~     randomized either to receive the intervention right away, or to a 14-week waitlist condition.~     Participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period,~     as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors,~     drug and alcohol use, and psychosocial functioning.~   "
182441|NCT01176812|"~     The face is arguably the most critical aesthetic unit of the body. As humans begin to age,~     numerous changes occur to the face. Changes include the formation of wrinkles, soft-tissue~     atrophy, gravitational descent resulting in sagging skin, loss of skin and muscle tone, and~     changes in bony architecture. These changes are potentiated in our population secondary to~     sun exposure and smoking. To combat the effects of aging on the face, a multitude of products~     and procedures exist to attempt to reverse the effects of sun damage and aging to achieve a~     youthful and rejuvenated appearance. There has been a shift from invasive procedures such as~     a facelift to noninvasive means using filling agents to restore lost contour deformities.~      The investigators hypothesis is that the use of dermal filling agents effectively delays the~     need for invasive procedures such as facelifts, and that patient satisfaction has increased~     with the evolution of recent dermal filling agents.~   "
182442|NCT01176799|"~     This is a single-centre, phase II randomized study of doxorubicin and cyclophosphamide (AC)~     with or without intermittent sunitinib in patients with measurable primary breast cancer who~     are receiving pre-operative chemotherapy.~      A lead-in phase I study was built into this protocol to determine the dose and duration of~     sunitinib that may achieve the desired effects of normalizing tumor vasculature prior to~     chemotherapy administration.~      A total of 64 patients with measurable primary tumor will be enrolled for the Phase II part~     of the study. Eligible patients will be randomized 1:1 to either arm A or arm B. Patients~     will be stratified according to metastatic status (metastatic vs non-metastatic) and presence~     or absence of clinical T4 disease.~      Arm A (Control arm):~      Doxorubicin 60mg/m2 day 1 Cyclophosphamide 600mg/m2 day1, every 3 weeks x 4 cycles~      Arm B (Experimental arm):~      Days -13 (or -7) to day 0 (total 7 or 14 days) - oral sunitinib daily (duration and dose as~     determined from the lead-in phase I study) Cycle 1: day 1 - Cycle 1 AC (60/600mg/m2); days~     15-21 - oral sunitinib daily Cycle 2: day 1 - Cycle 2 AC (60/600mg/m2); days 15-21 - oral~     sunitinib daily Cycle 3: day 1 - Cycle 3 AC (60/600mg/m2); days 15-21 - oral sunitinib daily~     Cycle 4: day 1 - Cycle 4 AC (60/600mg/m2)~      DCE-MRI scan will be performed serially to determine tumor response and change in tumor~     vascular parameters for each enrolled subject:~      Patient will be evaluated weekly for toxicity assessments and full blood count during cycle~     1, and on days 1 and 15 of each subsequent cycle. In addition, patients in Arm B will be~     evaluated weekly during the first two weeks of sunitinib administration prior to cycle 1 AC.~   "
182443|NCT01176786|"~     This study will look at the rate of infections developed by subjects comparing the use of~     disposable draping systems versus reusable draping systems in the operating room.~   "
182444|NCT01176773|"~     The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra~     Lip Injectable Gel for lip enhancement.~   "
182445|NCT01176760|"~     The aim of this study is to investigate the role of transmission via the vagal nerve for the~     effect of glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.~      The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous~     system and for this reason the investigators will research individuals with and without~     intact nervous supply.~   "
182446|NCT01176747|"~     The purpose of this study is to investigate the lung deposition and distribution pattern of~     Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a~     single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT~     DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic exposures~     to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.~   "
182447|NCT01176734|"~     The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the~     afferent branches of the nervus vagus around the human ear. The clinical trial is designed as~     a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve~     stimulation.~   "
182448|NCT01176721|"~     Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy~     and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in~     schizophrenia.~      Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive~     impairment,and aggressive behavior of treated schizophrenia patients.~   "
182449|NCT01176708|"~     The aim of the study is to investigate the significance of intact nerve supply to the liver~     for the glucagon-like peptide-1 (GLP-1) induced insulin secretion.~      The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and~     that these effects involve sensory afferent neurons, probably primarily parasympathetic.~   "
182456|NCT01176617|"~     The purpose of this study is to determine if continuous monitoring using an implantable loop~     recorder (ie. a device that is placed just underneath the skin of the chest and monitors the~     heart rate and rhythm) for a year long period after atrial fibrillation ablation may be~     superior to the current conventional monitoring strategy used by us for determination of~     atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia~     burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). Some data~     suggests that continuous monitoring over longer periods may be better in identifying~     recurrence of atrial fibrillation after ablation and thus assist in its overall management.~     The device being used for this study is the Reveal XT, which, is currently FDA approved for~     monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.~   "
182457|NCT01176604|"~     This is a Humanitarian Use Device study. A Humanitarian Use Device is a medical device~     intended to benefit patients in treatment or diagnosis of a disease or condition that affects~     or is manifested in fewer than 4,000 individuals per year in the United States. This consent~     and authorization form explains why this HUD study is being done and what your role will be~     if you choose to take part. This form also describes the possible risks connected with being~     in this study. After reviewing this information with the person responsible for your~     enrollment, you should know enough to be able to make an informed decision on whether you~     want to take part in the study. You may choose not to take part in this study~      You are being asked to take part in this study because you have liver cancer and are not~     eligible for surgery. You are being asked to receive humanitarian use device (HUD -- a device~     used only in patients with rare diseases) treatment at The University of Texas MD Anderson~     Cancer Center (MD Anderson).~      The goal of this study is to learn more about the patient experience, including any reported~     side effects and possible benefit related to the use of the TheraSphere device for treatment~     of liver cancer. Because treatment using the TheraSphere device must be designed specifically~     for each patient, the treatment process will also be monitored.~      The Humanitarian Use Device Program is for FDA approved device that is safe and provides~     probable benefit.~      TheraSphere is a humanitarian use device that is approved by the FDA for the treatment of~     rare disorders affecting less than 4,000 people in the U.S. each year.~      Up to 200 patients will receive the treatment. All will be enrolled at M.D. Anderson.~   "
182458|NCT01176591|"~     The proposed research will focus on investigating the determinants and consequences of CAD~     via measurement of physiological, behavioral and subjective effects of physiologic and~     psychologic stress cues in CAD volunteers in the laboratory, and through examination of the~     effects of the effects of Aprepitant, an NK1 antagonist, on the above effects. This study~     will examine the effects of the above stress cues on cocaine and alcohol craving under acute~     Aprepitant dosing, and under placebo conditions. The study is a within-subjects crossover~     design using 24 subjects.~   "
182459|NCT01176578|"~     The discovery of the role of endothelial progenitor cells (EPCs) and their involvement in the~     cardiovascular complications of type 2 diabetes (T2DM) would quickly have a significant~     impact on the millions of Americans who have T2DM. This project is designed to 1) determine~     the mechanisms underlying EPC dysfunction in older, sedentary adults with T2DM compared those~     with normal glucose metabolism and impaired glucose metabolism, and 2) determine if aerobic~     exercise training is an efficacious therapy for EPC dysfunction in T2DM, and whether~     improvement in EPC number and function translates to improved endothelial function, increased~     capillarization, and improved glucose metabolism in T2DM.~   "
182460|NCT01176565|"~     The specific aims of this study are to:~        1. Definitively determine the therapeutic benefit of the intensive treatment relative to~          the standard treatment in the proportion of patients with death and disability (mRS 4-6)~          at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.~        2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard~          treatment in the subjects' quality of life as measured by EuroQol at 3 months.~        3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard~          treatment in the proportion of hematoma expansion (defined as increase from baseline~          hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at~          24 hours on the serial computed tomographic (CT) scans.~        4. Assess the safety of the intensive treatment relative to the standard treatment in the~          proportion of subjects with treatment-related serious adverse events (SAEs) within 72~          hours.~   "
182461|NCT01176552|"~     This prospective study assesses toxicity and potential efficacy of granulocyte-macrophage~     colony-stimulating factor (GM-CSF), interferon (IFN) alpha and interleukin-2 (IL-2)~     postoperatively in patients with high-risk renal cell carcinoma (RCC).~   "
182462|NCT01176539|"~     The purpose of this study is to determine whether the respiratory rate provided by Kai~     Medical Non-Contact Respiratory Rate Monitors are as accurate as that provided by the~     currently used methods, including respiratory chest bands.~   "
182463|NCT01176526|"~     Social comparisons may function as a coping strategy, but their role in coping and quality of~     life has not been well characterized. The purpose of the current study is to investigate the~     relationships between cognitive appraisals; coping strategies; social comparisons; and~     quality of life among men with prostate cancer. The conceptual framework for this study is~     drawn from Festinger s Social Comparison Theory, Lazarus and Folkman s Transactional Model of~     Stress and Coping, and Mishel s Uncertainty in Illness Theory. A cancer diagnosis is~     accompanied by uncertainty about how cancer will affect one s life. Theory and empirical data~     suggest that in conditions of uncertainty, coping affects adjustment to a condition. Social~     comparisons have been postulated to be more prevalent in uncertain situations. Because little~     is known about how social comparisons operate, participants in this study will be recruited~     exclusively from prostate cancer support groups. Support groups provide a context in which~     individuals are likely to make social comparisons and to be cognizant of these comparisons.~     Prostate cancer provides a model of a common, chronic condition with complex etiology.~     Prostate cancer treatment may cause sexual, urinary, and bowel side effects, which may affect~     patients quality of life and elicit attempts to cope. One way of managing the prostate cancer~     experience may be to compare oneself to others who are doing better or worse than oneself on~     relevant dimensions. The interpretation of social comparisons may positively or negatively~     affect one s perceived quality of life. There have been no studies among prostate cancer~     patients that have quantitatively measured the use of social comparisons. There is also a~     paucity of research in this population regarding the predictors of coping strategies and the~     predictors of quality of life across multiple domains. This study will use a cross-sectional,~     mixed methods survey to investigate relationships between cognitive appraisals, coping, and~     quality of life and to qualitatively explore social comparisons among men with prostate~     cancer. Participants may complete the survey on paper or online. The primary outcomes are the~     use of coping strategies, including social comparisons, and quality of life. Individuals with~     a personal or family history of prostate cancer are currently seen by genetic counselors as~     part of research studies investigating the genetic basis of prostate cancer. If relationships~     are demonstrated between the social comparisons and quality of life, genetic counselors may~     want to assess patients social comparisons to evaluate how patients are coping with their~     condition.~   "
182531|NCT01175642|"~     This randomized trial is examining whether a treatment called cognitive remediation is more~     effective when it is paired with a social and functional skills training component.~   "
182464|NCT01176513|"~     Background:~      - GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers~     are interested in combining the drug with a small amount of radioactive material to allow~     prostate cancer lesions to appear more clearly on imaging scans. Researchers are also~     interested in determining whether the combination can help make cancer cells in pelvic lymph~     nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine~     individuals who are scheduled to have surgery on their prostate cancer.~      Objectives:~      - To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer cells~     in pelvic lymph nodes using positron emission tomography and magnetic resonance imaging~     scanning.~      Eligibility:~      - Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled~     to have prostate removal surgery.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood tests,~          and imaging studies.~        -  Participants will have magnetic resonance imaging (MRI) and positron emission tomography~          (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and PET scans~          may be performed on the same day or on different days, depending on the schedule set by~          the study researchers.~        -  Tissue samples taken during prostate removal surgery, including prostate tissue and~          pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148~          (18F).~   "
182465|NCT01176500|"~     Background:~        -  Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which~          preferentially binds with high affinity to alpha(v)beta(3) integrins, which are~          up-regulated in and may regulate angiogenesis.~        -  [18F]Fluciclatide is a new radiopharmaceutical developed for PET imaging~        -  Changes in [18F]fluciclatide uptake will be evaluated before and after treatment of~          patients with targeted antiangiogenic drugs~      Objectives:~      Primary~        -  To determine tumor uptake and retention of [18F]fluciclatide before and after 1 cycle of~          treatment with targeted anti-angiogenic therapy~        -  Secondary~        -  To assess the safety of multiple intravenous (IV) administrations of Fluciclatide [18F]~          Injection in subjects with solid tumors~        -  To obtain preliminary data on the relationships between [18F]fluciclatide as a~          pharmacodynamic marker and standard of care imaging markers of clinical response (e.g.~          contrast-enhanced (CE) static computed tomography (CT), bone scintigraphy, FDG-PET),~          obtained as part of routine clinical follow-up as specified in the referring protocols,~          as well as any optional imaging performed~      Eligibility:~        -  Patients greater than or equal to 18 years, with documented malignancy, and solid tumor~          greater than or equal to 1 cm outside of the liver, who are scheduled to enroll in an~          NCI therapy protocol using one of the anti-angiogenic agents described in the full~          protocol~        -  Platelet count greater than 75,000 x 10(6)/L, hemoglobin greater than 9g/dL, prothrombin~          time (PT) and aPTT less than 2 times normal limits.~        -  The subject has not received any targeted anti-angiogenic agents within 60 days prior to~          pre-treatment (baseline) [18F]fluciclatide administration~      Design:~      This study is intended to obtain preliminary data on the uptake and retention of~     [18F]fluciclatide before and after anti-angiogenic therapy. This will enable optimization of~     the imaging protocol, identification of the most relevant imaging parameters, and allow for~     calculation of the number patients required to power a larger study to assess the utility of~     PET imaging with [18F]fluciclatide as a pharmacodynamic biomarker in the context of targeted~     anti-angiogenic therapies. We expect to enroll 30 evaluable patients in this single center~     study. Subjects will undergo at least two [18F]fluciclatide PET/CT imaging studies, one~     pre-therapy and one following completion of 1 cycle of chemotherapy. An optional early~     post-therapy (2-7 days post therapy commencement) [18F]fluciclatide PET/CT may be performed.~     The magnitude of [18F]fluciclatide uptake on the pre- and post- treatment PET/CT studies will~     be evaluated to determine if there is a measureable difference in uptake. Data from the~     subject's referring therapy protocol will be reviewed for up to one year. An optional DCE-MRI~     scans of the target lesion may also be performed.~   "
182466|NCT01176487|"~     RATIONALE: 3-dimensional conformal radiation therapy may lessen side effects caused by~     palliative radiation therapy and improve the quality of life of patients with lung cancer.~      PURPOSE: This clinical trial is studying how well 3-dimensional conformal radiation therapy~     works in reducing the side effects of palliative radiation in patients with lung cancer.~   "
182467|NCT01176474|"~     The purpose of this study is to test the side effects of an investigational vaccine with an~     immune booster, or 2 different boosters together. Investigators also want to find out its~     effects on the immune system and whether it will decrease the chance that melanoma will~     return.~   "
182468|NCT01176461|"~     This is a pilot phase 1, open-label, single center, multi-dose, dose-escalation study of~     BMS-936558 in combination with or without a peptide vaccine.~      The purpose of this study is to test the side effects of an investigational vaccine with an~     immune booster. Investigators also wish to find out its effects on the patient's immune~     system and whether it will shrink their melanoma.~   "
182469|NCT01176448|"~     Dermabrasion has been the historical standard used for resurfacing scars on the skin.~     Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study~     intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.~   "
182470|NCT01176435|"~     This project will evaluate the effect of two doses of levodopa (L-DOPA) in a randomized,~     placebo-controlled, double-masked clinical trial to see if vision can be improved in~     individuals with albinism. The hypothesis is that providing L-DOPA to the retinas of these~     individuals may increase melanin pigment production. Increased melanin has previously been~     shown to be associated with improved vision.~   "
182471|NCT01176422|"~     Researchers hope to determine if the DNA is shortened in your body and determine if there is~     an increase in the protein that shortens DNA called telomerase.~   "
182472|NCT01176409|"~     The purpose of this study is to compare the levels of immune and inflammatory markers among~     HIV-1, HSV-2 co-infected adults achieving plasma HIV RNA suppression to <50 copies/mL,~     between those randomized to valacyclovir and placebo, over a twelve-week intervention period.~   "
182473|NCT01176396|"~     The goal of this project is to create a Practice Based Research Network with 30 researcher~     dentists calibrated on the administration of a caries risk assessment and the treatment~     modalities recommended based on the caries risk assessment results (Caries Management by Risk~     Assessment - CAMBRA), and to conduct a 2-year CAMBRA study in those dental offices.~     Participating dentists will be a mix of general practitioners and pediatric dentists selected~     from private practice, part time university faculty, large group practices, or community~     clinics. Participating practices will collect baseline data and patient progress and report~     on patient acceptance and compliance, and the effectiveness of treatment.~      The program's duration is anticipated to be approximately four years. Year one will be~     dedicated to program, protocol and evaluation design, and recruitment, selection and~     calibration of researcher dentists. Years two and three will be the research and data~     collection time period, and year four will be dedicated to evaluation.~   "
182483|NCT01176266|"~     This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by~     gene mutations or changes. These gene mutations cause low levels of an enzyme needed to~     harden bone. The purpose of this study was to test the safety and efficacy of a study drug~     called asfotase alfa (human recombinant tissue non-specific alkaline phosphate fusion~     protein) to see what effects it has on patients 5 years of age or less with HPP.~   "
189742|NCT01080911|"~     This study aims to compare the effect of spinal morphine between the dose 0.05 mg and 0.1 mg~     on the amount of morphine during the first 24 hours postoperative.~   "
182474|NCT01176383|"~     Professor RP Young (Associate Professor of Medicine and Molecular Medicine, School of~     Biological Sciences, University of Auckland) and his team have developed a reliable genetic~     test Respiragene based on 20 single nucleotide polymorphisms that can be used (together~     with details of personal and family history) to calculate a smoker's lifetime risk of~     developing lung cancer. The expectation is that whatever the score (estimated lifetime risk~     will vary from 5% to 50%) the result will counter optimism bias of the smoker and encourage~     smoking cessation and this assumption is supported by previous research on similar tests and~     smoking cessation. The investigators plan to recruit two groups of subjects for smoking~     cessation but only one group will have the Respiragene test. Eight weekly smoking cessation~     sessions will be carried out at a Surrey primary care medical centre and will follow the~     usual format for National Health Service smoking cessation clinics using Champix~     (varenicline), counselling and the carbon monoxide breath meter but with added: evaluation~     questionnaires, fagerstrom nicotine addiction score, salivary cotinine (metabolite of~     nicotine) test. The main outcome measures will be estimation of smoking cessation at 4 weeks~     and six months after the completion of the seven smoking cessation sessions. Successful~     smoking cessation has to be confirmed by negative salivary cotinine at 4 weeks and six months~     and questionnaires will be used to estimate the influence of the Respiragene test compared~     with standard procedures such as counselling and the carbon monoxide breath readings.~   "
182475|NCT01176370|"~     The C-Pulse Study is evaluating the safety and performance of a new product for the treatment~     of heart failure. The product is designed to help reduce the symptoms of heart failure and~     help patients function better with daily activities. The study evaluates multiple measures of~     heart function and whether the patient's quality of life has been improved since the device~     implant. The patient will have several visits after the device implant to assess how well~     they are doing and to monitor any safety concerns.~   "
182476|NCT01176357|"~     Coronary artery disease (CAD), the most common type of heart disease, is caused by hardening~     of the arteries, or atherosclerosis that is an inflammatory process in which immune~     mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions~     in the arterial trees. Epidemiological studies have found that increased cardiovascular risks~     are associated with increased levels of inflammatory cytokines (eg, interleukin-6 [IL-6] and~     tumor necrosis factor-alpha[TNF-alpha]) or their hepatic product, C-reactive protein (CRP).~     Higher expression of interleukin-Ibeta(IL-1beta),IL-6, monocyte chemotactic protein-1~     (MCP-1), and TNF-alpha were observed in epicardial adipose tissues in patients with CAD.~     These findings suggested that the pericoronary tissues could be a source of inflammatory~     mediators or act as paracrine that lead to vascular inflammation on CAD pathogenesis.~     However, adiponectin, a kind of adipocytokine, produced and secreted exclusively by adipose~     tissue, has been reported to have a variety of anti-inflammatory functions against~     atherosclerosis, resulting in risk reduction for incidence of CAD events. It remains unclear~     whether adiponectin and inflammatory mediators in mediastinal adipose tissue contribute to~     CAD. We therefore aim to analyze the expression of adiponectin and inflammatory mediators in~     mediastinal adipose tissue between patients with CAD and with valve diseases, and to~     correlate these parameters with clinical atherosclerotic risks, medications (statins or~     antiplatelet), and blood sugar.~   "
182477|NCT01176344|"~     Observational evidence suggests that vitamin D deficiency may have a role in the causes of~     osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There~     is, however, no evidence which shows that intervening with vitamin D supplementation can slow~     the progression of OA. This study is to determine if vitamin D supplementation can reduce~     knee pain and slow knee cartilage loss in OA patients comparing with a placebo. Use of MRI~     will provide sensitive measures of knee OA changes.~   "
182478|NCT01176331|"~     In a retrospective study, a combined 20 and 23-gauge pars plana vitrectomy procedure was~     performed in 21 eyes for various indications and proposed as a transition procedure to~     23-gauge transconjunctival vitrectomy. Through use of combination of procedures postoperative~     complications, surgical trauma and healing time was decreased; operating time was reduced;~     costs were decreased.~   "
182479|NCT01176318|"~     This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.~      60 patients to be included who are adult patients admitted to hospital with a clinical~     diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute~     exacerbation of COPD will be defined as sustained worsening of the patient's condition with~     an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence,~     necessitating a change in regular medication.~      The primary objective of this study is to evaluate the effectiveness of standard care plus~     erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder)~     measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus~     placebo.~   "
182480|NCT01176305|"~     The purpose of this study is to describe the incidence of thromboembolic events in relation~     to pregnancy and when in pregnancy and the puerperal period.~   "
182481|NCT01176292|"~     The goal of this study is to determine if the rotating platform high flex design provides~     improved flexion compared to the standard rotating platform TKA.~   "
182482|NCT01176279|"~     The technique of blood samples extraction from the radial artery through an arterial catheter~     with a 3-way stopcock and automated washing with valve of fast flow is better than the one~     carried out through a fixed reusable arterial blood sample syringe and its manual washing~     because it shows a minor incidence of the complications originated from technical~     manipulation as infection, pseudo-aneurysm, ischemia or thrombosis of radial artery or~     obstruction of the catheter.~      The purpose of this study is to evaluate the efficacy, in terms of adverse effects, of blood~     samples obtention using an arterial catheter with needless connector closed system or an~     arterial catheter with an arterial blood sample syringe.~      Also a second purpose is to compare once a day (at the same time) the values of glycose blood~     levels between bedside glucometer determination of arterial catheter extraction and capillar~     puncture, and lab determination of glycose from venous puncture, in order to determinate~     fluctuation in glycose levels due to peripherical hypoperfusion or to vasoactive drugs~     received by these in-intensive care unit patients.~   "
182484|NCT01176253|"~     To investigate the use of methylation-specific PCR (MSP) assays to detect human beta~     cell-specific gene methylation patterns in serial blood samples drawn from newly diagnosed~     Type 1 diabetics.~   "
182485|NCT01176240|"~     This is a study to evaluate the effects of an investigational drug, Droxidopa, in~     participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's~     disease. Droxidopa is being studied to determine the effects on blood pressure changes upon~     standing up (orthostatic challenge). Symptoms and activity measurements, including patient~     reported falls, will be evaluated to determine the effectiveness of the study drug.~      Symptoms of NOH may include any of the following:~        -  Dizziness, light-headedness, feeling faint or feeling like you may blackout~        -  Problems with vision (blurring, seeing spots, tunnel vision, etc.)~        -  Weakness~        -  Fatigue~        -  Trouble concentrating~        -  Head & neck discomfort (the coat hanger syndrome)~        -  Difficulty standing for a short time or a long time~        -  Trouble walking for a short time or a long time~      The study duration is a maximum of approximately 14 weeks including up to 2 weeks for~     screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and~     a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow~     approximately 211 randomized patients. An extension study is also available to continue~     treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored~     by Chelsea Therapeutics and is enrolling by invitation only.~   "
182486|NCT01176227|"~     The Canadian College of Naturopathic Medicine is conducting a research study on Irritable~     Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring~     gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is~     characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and~     bloating.~      The medicines that are currently used to help people with IBS are not as effective as we~     would like them to be. These medicines are usually only prescribed to reduce the pain of IBS~     and not actually treat the disorder itself. Recently, scientists have found that probiotics~     (beneficial bacteria that live inside humans) may help reduce the painful symptoms and~     diarrhea that are part of IBS.~      This research is being conducted to determine whether this particular combination of three~     probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium~     longum) will reduce the symptoms of IBS.~   "
182487|NCT01176214|"~     Background:~      One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all~     ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy).~     As shown previously, predisposing factors for tracheostomy are hematoma volume, hemorrhage~     location, presence of intraventricular hemorrhage (IVH), and occlusive hydrocephalus as well~     as presence of COPD (Huttner HB et al 2006 CVD).~      Sustained restricted vigilance and impaired consciousness after ICH is likely to result in~     failure of extubation, raise in incidence of ventilator-associated pneumonia, increased~     amount of sedative drugs and prolonged duration of neurocritical care.~      Hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical~     ventilation.~      Basic hypothesis:~      Compared to patients with conventional (late) tracheostomy between day 12 - 14, patients~     with early tracheostomy within 72h after admission will have:~        -  shorter cumulative time of mechanical ventilation~        -  less incidence of ventilator-associated pneumonia~        -  less consumption of sedative drugs~        -  shorter duration of stay in neurocritical care unit~      Randomization:~      Consecutive eligible patients are randomly assigned to Either early tracheostomy within 72h~     after hospital admission Or late tracheostomy (= control group; undergoing conventional~     tracheostomy between day 12 - 14 if extubation fails) Both groups receive plastic~     tracheostomy~   "
182488|NCT01176201|"~     This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and~     Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.~   "
182489|NCT01176188|"~     Children who become critically ill and require Pediatric Intensive Care Unit~     (PICU)hospitalization may develop negative psychological outcomes following discharge. This~     pilot study will test a nursing intervention that seeks to promote child comfort, sleep and~     psychological well-being during and following PICU hospitalization.~      Study objectives are to:~        1. test the feasibility and acceptability of a PICU comfort care intervention that can be~          administered by nursing staff~        2. examine the feasibility and acceptability of data collection procedures~        3. pilot test outcome measures~        4. determine effect sizes to inform sample size calculation for a future multi-centred~          randomized controlled trial (RCT).~      The intervention will take place in the PICU, and consists of a parental soothing activity~     followed by a quiet period in which earmuffs are placed over the child's ears to block noise.~     Children's sleep time and comfort level will be monitored in the PICU, and the investigators~     will follow them for 3 months post-discharge to examine the effects of the intervention on~     psychological well-being.~   "
182490|NCT01176175|"~     Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the~     minimum effective dose of progesterone microspheres suspension, which administered by weekly~     intramuscular injection, will be able to induce transformation from a proliferative~     endometrium to a secretory endometrium.~      Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial.~      Sites: 1 Subjects: 48 postmenopausal women.~   "
182491|NCT01176162|"~     In the neonatal period, the human kidney is characterized by a functional immaturity~     responsible for an impaired ability to regulate water and sodium homeostasis, which is~     exacerbated by prematurity. This altered sodium handling could be related to a partial renal~     aldosterone resistance. Renal sodium reabsorption and potassium excretion are mainly~     controlled by aldosterone, after binding to the mineralocorticoid receptor (MR). The~     investigators have analyzed MR expression throughout human and mouse renal development, and~     the investigators found a weak MR expression at birth. The investigators have conducted a~     pilot study in full-term newborns, which confirmed a partial neonatal aldosterone resistance.~     This study also highlighted that urinary aldosterone is the best index to accurately assess~     aldosterone sensitivity at birth.~   "
182492|NCT01176149|"~     The aim of this pilot study is to evaluate the validity and feasibility of an educational~     approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely~     changes in therapy, when needed.~   "
182493|NCT01176136|"~     Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed~     childhood disorders, with prevalence rates estimated at 8% (Froehlich et al. 2007). Several~     of the primary symptoms of ADHD relate to problems with temporal and materials organization~     (i.e. often has difficulty organizing tasks and activities, often loses things, is often~     forgetful, and often fails to finish school-work, chores, or duties; APA, 2000). In the~     school setting, problems with organization manifest as forgetting to complete or losing~     homework assignments, difficulties planning for the completion of long-term projects and~     studying for tests, and problems keeping class materials organized. These organizational~     difficulties become particularly problematic in middle school and can result in considerable~     academic impairment (Evans, Serpell, & White, 2005). Children with ADHD underachieve~     academically and are more likely than their peers to receive failing grades, be retained and~     to drop out of school (Barkley, Fischer, Edelbrock, & Smallish, 1990).~      Given the relationship between temporal and materials organization and poor school~     performance, it is clear there is a need for interventions to address these difficulties. We~     recently sought to address this need by completing a small randomized trial of an~     organizational skills intervention for children with ADHD (Langberg, Epstein, Urbanowicz,~     Simon, & Graham, (2008). The intervention was highly effective in improving materials~     organization and homework management and resulted in significant improvements in homework~     problems and grade point average. These results demonstrate the considerable promise of~     organizational skills interventions for children with ADHD. However, the Langberg et al.~     intervention was implemented as an after-school program operated by research staff with~     minimal involvement from school personnel. In order to promote the widespread adoption of~     interventions that address the organizational skills deficits of children with ADHD, the~     intervention must be feasible for school counselors and psychologists to implement within the~     time constraints of a typical school day. Accordingly, the primary goal of this study is to~     adapt and refine the existing intervention protocol (Langberg et al., 2008) to create a~     product that is highly acceptable to parents, children, teachers, school counselors and~     school psychologists and is feasible for school personnel to implement during the school day.~      In Phase I of the proposed research, middle school counselors, psychologists, teachers,~     middle school students with ADHD and their parents will consult with the intervention~     developers to modify the after-school treatment protocol for in-school implementation. An~     intervention protocol will be developed. The intervention will be piloted with ten children~     in order to identify barriers to implementation. Measures of treatment fidelity, skills~     acquisition, and satisfaction will be completed. These data will inform additional~     modifications of the protocol and further improve feasibility/acceptability of the~     intervention procedures.~      In Phase II of the study, school counselors/psychologists from at least four separate school~     districts will implement the protocol developed in Phase I. Using a waitlist control design,~     sixty children with ADHD in grades 6, 7, and 8 will receive the intervention. Organizational~     skills, grade point average, and academic impairment will be evaluated at baseline, post~     intervention and at 8-week follow-up. After implementing the intervention, all participants~     (i.e., teachers, counselors, psychologists, children and parents) will participate in a~     series of focus groups and will complete intervention satisfaction questionnaires. These data~     will inform final revisions to the intervention protocol. The resulting product will be an~     intervention that targets organizational skills in children with ADHD that has potential for~     widespread school-based dissemination. The final intervention protocol and effect size~     estimates from the proposed research will lay the foundation for an IES Goal III test of~     efficacy.~      The specific aims of the project are as follows:~        1. Utilize the existing organizational skills intervention protocol (Langberg et al. in~          press), focus group and case study data to develop an empirically and clinically~          informed manualized temporal and materials organization intervention for middle school~          children with ADHD aimed at reducing academic impairment (Phase I).~        2. Refine and finalize the intervention protocol through a waitlist control trial (N=60) in~          a minimum of four diverse school districts, collection of clinical outcomes and~          completion of follow-up focus groups to assess satisfaction, feasibility, and~          acceptability (Phase II).~   "
182625|NCT01174407|"~     The purpose of this study is to determine a possible implication of CD21, CD35 and CD55 in~     the pathogenesis of age-related macular degeneration. The aim is to asses a difference in~     expression rates of these factors on AMD-patients and a healthy control group.~   "
182494|NCT01176123|"~     Understanding the effectiveness of Cognitive Behavioral Therapy for trauma-related insomnia~     (CBT-I) is important because sleep difficulties often persist after traditional post-trauma~     treatments are completed and other trauma-related symptoms have resolved. The objective of~     this study is to examine whether CBT-I will equivocally reduce problems falling and staying~     asleep (insomnia) related to military-related PTSD when administered in person versus through~     telephone therapy to veterans living in rural areas.~      Rural populations are at a disadvantage in receiving treatment because of lack of access to~     healthcare services. Telemedicine uses technology (e.g., telephones) to provide distance~     counseling to the populations who lack access to health care. Thus, telephone-counseling~     strategies could provide broad access to interventions for management of trauma-related~     insomnia.~      Veterans who live more than 30 miles from Veterans Affairs (VA) PTSD specialty services will~     be offered participation in this study. All veterans receive 6 weeks of individual CBT-I for~     trauma-related insomnia. Participants will be randomized to one of two treatment conditions:~     (1) CBT-I in person or (2) CBT-I via telemedicine (defined as receiving treatment by~     telephone). No changes will be made to the CBT-I, other than mode of delivery, for the~     telemedicine group.~      Through this study the investigators hope to demonstrate the effectiveness of CBT-I for~     trauma-related insomnia can be delivered effectively to rural veterans in person and via~     telemedicine.~   "
182495|NCT01176110|"~     It is known that perioperative hypothermia can influence the postoperative outcome~     negatively.~      The most important complications are cardiac, increased blood loss with need for transfusion~     and a significantly increased wound infection rate.~      The thermal redistribution after the induction of anesthesia is on of the reasons for~     perioperative hypothermia. Another reason is negative heat balance during surgery.~      Further negative side effects of hypothermia are an increase of blood viscosity and thus a~     higher risk for thrombosis, coagulopathy and thus an increased risk of bleeding.~      The aim of the study is to evaluate if patients with a perioperative active thermal~     management during an interventional minimal invasive valve replacement have a significantly~     higher body temperature at the end of the operation than patients without an active thermal~     management. Secondary outcome variables are complication rates, length of mechanical~     ventilation and length of ICU treatment.~   "
182496|NCT01176097|"~     The purpose of this study is to investigate the safety and tolerability of AZD5658 following~     ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated~     dose.~   "
182497|NCT01176084|"~     The purposes of this study are:~      To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of~     heart health including blood fats, blood clotting factors, inflammatory markers and levels of~     body fat.~      To investigate the added effect on heart health that regular moderate exercise may have when~     combined with a low carbohydrate diet in obese men.~   "
182498|NCT01176071|"~     The investigators hypothesize that early galactomannan and beta-D-glucan features, namely the~     height of the initial value at the time of diagnosis and the subsequent rate of marker decay~     within the first week(s) following therapy (day 7, day 14) are important factors in~     predicting clinical outcome.~   "
182499|NCT01176058|"~     In the treatment of patients with candidemia and/or other forms of invasive candidiasis ,~     Anidulafungin is at least as effective and safe as Fluconazole.~   "
182500|NCT01176045|"~     The primary objective of this study is to determine how pre & post-operative tear osmolarity~     levels relate to rates of dry eye symptoms related to refractive surgery and if differences~     exist in patients who are pre-treated with ocular lubricants vs. those treated only~     post-operatively.~   "
182501|NCT01176032|"~     The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels~     of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in~     hypertensive patients.~   "
182502|NCT01176019|"~     The purpose of this study is to determine whether an interactive education program for~     prenatal testing is effective in improving pregnant women's understanding of and expectations~     towards prenatal screening and diagnosis.~   "
182503|NCT01176006|"~     Background:~      -DOCK8 deficiency is a genetic disorder that affects the immune system and can lead to severe~     recurrent infections and possible death from infections or certain types of cancers,~     including blood cancers. A stem cell transplant is a life-saving treatment for this~     condition. In this study we are evaluating the efficacy and safety of transplant from~     different donor sources for DOCK8 deficiency. The donors that we are using are matched~     siblings, matched unrelated donors, and half-matched donors, so called haploidentical related~     donors, such as as mothers or fathers or half-matched siblings.~      Objectives:~      -To determine whether transplant of bone marrow cells from different types of donors corrects~     DOCK8 deficiency.~      Eligibility:~        -  Donors: Healthy individuals between 4 and 60 years of age who are matched with a~          recipient.~        -  Recipient: Individuals between 5 and 40 years of age who have DOCK8 deficiency, have~          suffered one or more life-threatening infections, or have had certain viral related~          cancers of cancer and have a stem cell donor.~      Design:~        -  All participants will be screened with a physical examination and medical history.~        -  DONORS:~             -  Donors will donate bone marrow cells or blood stem cells. If donating blood stem~               cells, donors will receive injections of filgrastim to release stem cells into the~               blood. After 5 days of filgrastim injections, donors will have apheresis to donate~               stem cells and white blood cells that are present in the blood.~             -  Donors who provide the stem cells through bone marrow donation will have their bone~               marrow cells harvested in the operating room.~        -  RECIPIENTS:~             -  Recipients receiving matched related or unrelated donors will receive 4 days of~               chemotherapy with busulfan and fludarabine to suppress their immune system and~               prepare them for the transplant. Donors receiving haploidentical related donors~               will receive two doses of chemotherapy with cyclophosphamide, 5 days of~               fludarabine, 3 days of busulfan, and one dose of radiation to suppress their immune~               system and prepare them for the transplant.~             -  After the initial chemotherapy and radiation, recipients will receive the donated~               stem cells as a single infusion. Recipients may also receive white blood cells from~               their stem cell donor to encourage acceptance of the stem cells.~             -  After the stem cell transplant, recipients will receive two days of a chemotherapy~               called cyclophosphamide on day's + 3 and + 4 followed by two drugs tacrolimus and~               mycophenolate to prevent graft versus host disease where the donor cells attack the~               patient's body. All patients will remain in the hospital for approximately 1 month,~               and will be followed with regular visits for up to 3 years with periodic visits~               thereafter to evaluate the success of the transplant and any side effects.~   "
182519|NCT01175798|"~     Dialysis patients often suffer from defects in their immune system (that part of the body~     which fights infection). Evidence suggests that Vitamin D deficiency may have a negative~     effect on immunity, and many dialysis patients are deficient in Vitamin D. We believe that by~     giving Vitamin D to dialysis patients who are deficient, we may help improve their immune~     system. This study will test that idea.~   "
182577|NCT01175044|"~     The purpose of this study is to examine the efficacy of a dilute betadine solution in~     reducing infectious complications in revision total knee arthroplasty. The investigators will~     enroll patients who are scheduled to undergo a revision total knee arthroplasty. Patients~     will be randomized into two groups. The treatment group will receive a dilute betadine lavage~     prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation and~     the control group will receive the 2000ml sterile saline lavage alone.~   "
182504|NCT01175993|"~     Background:~        -  Traumatic brain injury may have a range of effects, from severe and permanent disability~          to more subtle functional and cognitive deficits that often go undetected during initial~          treatment. To improve treatments and therapies and to provide a uniform quality of care,~          more research is needed into different treatments for traumatic brain injury.~        -  Exercise has been shown to improve movement and balance in people with strokes, cerebral~          palsy, and other conditions that affect the brain, and can improve symptoms of memory~          problems or depression. Bright light therapy has also been shown to improve mood in~          people with depression. Researchers are interested in studying problems with movement,~          balance, thinking, and mood in people with traumatic brain injury. By comparing the~          effects of exercise and bright light exposure on brain function, new treatments may be~          developed for acute traumatic brain injury.~      Objectives:~      - To compare the effects of exercise and bright light therapy on the brain function of~     individuals with traumatic brain injury.~      Eligibility:~      - Individuals between 18 and 44 years of age who either have been diagnosed with traumatic~     brain injury or are healthy volunteers.~      Design:~        -  Individuals with traumatic brain injury will have four outpatient evaluation visits at~          the clinical center, a 3-month home exercise program, and a 3-month bright light~          exposure program at home. Healthy volunteers will have one evaluation visit at the~          clinical center.~        -  At the first study visit, all participants will have a full physical examination and~          medical history. Individuals with traumatic brain injury will also have an eye exam to~          determine if it is safe for them to receive light therapy.~        -  All participants will have the following initial tests:~        -  Tests of walking and movement, including monitoring by a physical therapist; tests to~          record joint movement and evaluate muscle function; tests that combine movement,~          thinking, and speaking; and balance and reaction time tests.~        -  Magnetic resonance imaging scans~        -  Tests of thinking and mood, including questionnaires, computerized tests, and simple~          action tests.~        -  Participants with traumatic brain injury will have separate 3-month sessions of exercise~          and bright light therapy, with additional evaluation visits between each 3-month session~          and at the end of the study. Between the 3-month sessions, participants will have 1~          month with no intervention.~        -  Exercise sessions will involve regular workouts on an elliptical machine for 30 minutes~          for 5 days a week, and bright light therapy sessions will involve sitting in front of a~          light box for 30 minutes for 5 days a week. Participants will keep a journal to monitor~          the effects of the therapy.~   "
182505|NCT01175980|"~     This phase II trial studies how well vorinostat works in treating patients with adenoid~     cystic carcinoma that has come back (recurrent) or that has spread from where it started to~     nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body~     (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
182506|NCT01175967|"~     RATIONALE: Measuring changes in performance status and symptoms distress in patients with~     cancer may help doctors predict how patients will respond to treatment, and may help the~     study of cancer in the future.~      PURPOSE: This clinical trial is studying changes in performance status and symptoms distress~     in older patients with advanced ovarian epithelial cancer undergoing surgery and/or~     chemotherapy.~   "
182507|NCT01175954|"~     Primary Objective:~      Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in~     cognitive, mood or quality of life measures.~      To determine the cognitive and behavioral side effects of lacosamide in patients with partial~     epilepsy and follow them for a period of 24 weeks using a neuropsychological test battery~     drawing on tests commonly used and designed to maximize sensitivity to drug effects.~      Secondary Objectives:~      To determine if any significant changes in cognitive, mood or quality of life measures are~     dependent upon changes in seizure severity, neurotoxicity, adverse events, or Lacosamide~     dosage.~   "
182508|NCT01175941|"~     This is a study to examine the effect of alpha adrenergic stimulation of the anal canal and~     rectum on parameters affecting the control of defecation in subjects with faecal~     incontinence. The study will investigate the effects of rectal suppositories containing 10 mg~     NRL001 given for seven days, once daily. Rectal compliance and median anal resting pressure~     will be considered the primary objective of the study. A pharmacokinetic evaluation plus~     safety and tolerability assessment including monitoring of electrocardiograms (ECGs), blood~     pressure and heart rate will also be evaluated as secondary objectives.~   "
182509|NCT01175928|"~     The purpose of this study is to evaluate the efficacy of the NormaTec PCD, a non-invasive~     pneumatic compression device with the patented peristaltic pulse pneumatic waveform, in the~     treatment of Diabetic Peripheral Neuropathy (DPN).~      The study will compare treatment with a NormaTec PCD and a sham device to assess whether the~     NormaTec PCD improves the signs and symptoms of DPN.~   "
182510|NCT01175915|"~     The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for~     mild type of hand-foot-mouth disease.~   "
182511|NCT01175902|"~     To prove the non-inferiority of the fixed timolol-dorzolamide combination (Cosopt) compared~     to 0.005% latanoprost (Xalatan) in the aspects of intraocular pressure (IOP) and ocular~     perfusion pressure (OPP) in subjects with normal tension glaucoma (NTG)~      Clinical hypotheses. Primary hypothesis~        -  Cosopt group is non-inferior to Xalatan group in diurnal IOP reduction.~      Secondary hypothesis~        -  Cosopt group is non-inferior to Xalatan group in diurnal diastolic and systolic OPP.~   "
182512|NCT01175889|"~     The Megadyne Ace™ Incision/ Dissection study is a post market, prospective assessment of the~     E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted~     procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts,~     bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination~     thereof.~   "
182513|NCT01175876|"~     Remote limb ischemic preconditioning is neuro-protective and anti-inflammatory for ischemia-~     reperfusion injury. As the extent of its effect is unknown, the investigators will use~     clinical outcome, serum biochemical markers and diffusion-weighted magnetic resonance imaging~     (DW-MRI)to determine the extent of its neuro-protective and anti-inflammatory effect.~   "
182514|NCT01175863|"~     This study is a prospective, randomized, multi-center, open label trial to compare the~     clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow~     Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary~     artery lesion.~   "
182515|NCT01175850|"~     The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral®~     drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery,~     as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides~     the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel)~     from the balloon surface into the vessel walls. This drug absorption is intended to limit the~     chances and the entity of artery re-narrowing over time.~   "
182516|NCT01175837|"~     This clinical trial studies short-term fasting before chemotherapy in treating patients with~     cancer. Fasting before chemotherapy may protect normal cells from the side effects of~     chemotherapy.~   "
182517|NCT01175824|"~     The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal~     insulin glargine and once-daily prandial insulin lispro, in participants with Type 2~     Diabetes.~   "
182518|NCT01175811|"~     The purpose of the study is to compare the effects on overall glycaemic control of two~     insulin intensification therapies.~   "
182520|NCT01175785|"~     This phase II trial is studying the safety and potential efficacy of infusing non-human~     leukocyte antigen matched ex vivo expanded cord blood progenitors with one or two~     unmanipulated umbilical cord blood units for transplantation following conditioning with~     fludarabine phosphate, cyclophosphamide and total body irradiation, and immunosuppression~     with cyclosporine and mycophenolate mofetil for patients with hematologic malignancies.~     Chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation~     given before an umbilical cord blood transplant stops the growth of leukemia cells and works~     to prevent the patient's immune system from rejecting the donor's stem cells. The healthy~     stem cells from the donor's umbilical cord blood help the patient's bone marrow make new red~     blood cells, white blood cells, and platelets. It may take several weeks for these new blood~     cells to grow. During that period of time, patients are at increased risk for bleeding and~     infection. Faster recovery of white blood cells may decrease the number and severity of~     infections. Studies have shown that counts recover more quickly when more cord blood cells~     are given with the transplant. We have developed a way of growing or expanding the number~     of cord blood cells in the lab so that there are more cells available for transplant. We are~     doing this study to find out whether or not giving these expanded cells along with one or two~     unexpanded cord blood units is safe and if use of expanded cells can decrease the time it~     takes for white blood cells to recover after transplant. We will study the time it takes for~     blood counts to recover, which of the two or three cord blood units makes up the patient's~     new blood system, and how quickly immune system cells return.~   "
182521|NCT01175772|"~     Preclinical studies showed that metronomic chemotherapy can induce tumor regression secondary~     to apoptosis of the tumor blood vessels. This effect was increased by combining metronomic~     chemotherapy with anti-angiogenic drugs. Metronomic chemotherapy has already proved clinical~     effects too, especially on patients with breast or prostate carcinoma. This study is aimed to~     test the efficacy of an experimental metronomic chemotherapy regimen in a cohort of patients~     with ovarian cancer. Patients will receive the proposed regimen as maintenance treatment~     following response induction by the conventional maximal tolerated dose (MTD) regimen of~     Carboplatin and Paclitaxel. Our regimen will include Cytophosphan combined with two agents~     which are expected to act as indirect angiogenic inhibitors: (a) celecoxib, as a selective~     COX-2 inhibitor and (b) low-dose Methotrexate, as successfully practiced for suppressing the~     inflammatory manifestations of rheumatoid arthritis. All components of our regimen will be~     administered orally and continuously for one year based on the hypothesis that its~     anti-angiogenic properties will be able to suppress the recovery of residual disease, thus~     extending the time to progression (TTP), and possibly the overall survival as well.~   "
182522|NCT01175759|"~     The EVE- technology is intended for determination of intolerance or sensitivity to female sex~     hormones among women with hormone-related conditions and for further treatment by~     desensitization procedure inducing a tolerance to the hormones the women are sensitive to.~      This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to~     detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy~     Loss (URPL) and in Control parous, healthy women.~      The Skin Test Panel includes four female hormones and three control solutions.~      Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the~     subject's menstrual cycle. The skin reactions are examined by physician for erythema and~     wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following~     month.~      Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy~     loss (UPRL) and healthy groups.~      Following achievement of the significant differences between both groups the immune profile~     of the healthy and UPRL subjects will be investigated.~   "
182523|NCT01175746|"~     Since nicardipine is known to protect kidney function, nicardipine infusion will result in~     better renal parameters measured in this study.~   "
182524|NCT01175733|"~     The purpose of this study is to investigate whether the addition of panitumumab to~     radiotherapy plus gemcitabine will increase the number of patients who are alive and~     progression free at 7 months.~   "
182525|NCT01175720|"~     The aim of this study is to test a surgical technique for the treatment of gingival~     recessions. The hypothesis of the study is to promote greater root coverage and better~     healing.~   "
182526|NCT01175707|"~     This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous~     (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment~     of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in~     participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive~     vancomycin in a home-infusion setting.~   "
182527|NCT01175694|"~     Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with~     lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a~     highly selected subgroup of patients with low risk invasive carcinoma and low risk duct~     carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of~     pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial~     Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal~     carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular~     regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II~     study. According to study protocol altogether 200 female patients will be treated.~   "
182528|NCT01175681|"~     Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery~     including coronary artery bypass graft surgery, congenital heart disease and aneurysm.~     However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one~     of the major heart diseases requiring surgery in China. Thus, the investigators chose heart~     valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac~     protective effect during heart valve surgery.~   "
182529|NCT01175668|"~     The study plans to compare the use of Clonidine versus Phenobarbital as an additional~     medication to neonatal morphine sulfate for treatment of newborn infants undergoing drug~     withdrawal symptoms due to mother's use of opioid drug use. The investigators hypothesis is~     that use of Clonidine will lead to shorter duration of treatment, hospital stay and thereby~     early discharge home.~   "
182668|NCT01173848|"~     The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in~     raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney~     disease who are not on dialysis.~   "
182532|NCT01175629|"~     The purpose of The Veteran Health Study (CSP #569) is to better understand the mental and~     physical health of veterans as they get older. We are inviting approximately 10,000 members~     of the Vietnam Era Twin (VET) Registry to participate. As veterans approach their~     mid-sixties, it is important to understand the impact of wartime deployment on health and~     mental health outcomes nearly 40 years later.~      The investigators will assess the prevalence of post-traumatic stress disorder (PTSD) and~     other mental and physical health conditions for Vietnam era veterans, and explore the~     relationship between PTSD and other conditions.~      CSP #569 involves 3 phases of data collection. In Phase I, VET Registry members are invited~     to complete a paper and pencil questionnaire including items on physical and mental health,~     disability, health behaviors, demographic information and use of health care services. After~     completing Phase I, VET Registry members are invited to Phase II which involves a telephone~     interview about mental health. In Phase III, some of those who participated in Phase I will~     be invited to a sub-study confirming self-reported heart disease and diabetes using a~     provider survey.~      Data collected for CSP #569 will be combined with existing VET Registry data. This will~     provide a rich picture of the health of Vietnam era veterans and the influence of PTSD on the~     lives of veterans.~   "
182533|NCT01175616|"~     The purpose of this study is to determine whether creatine will be helpful as an adjunctive~     treatment for treatment-resistant major depressive disorder (MDD) in female and male~     Veterans. We hypothesize that Veterans receiving creatine will show decreased depressive~     symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). We will also~     use 31-Phosphorus Magnetic Resonance Spectroscopy (31-P MRS) brain scans to compare levels of~     neurochemicals related to energy metabolism in the brain, before-and-after treatment with~     creatine, and between healthy controls and MDD participants.~   "
182534|NCT01175603|"~     The goal of this study is to determine whether a 6 week intervention is effective in~     preventing the worsening of depressive symptoms and development of clinical depression in~     low-income African American pregnant and recently delivered women who are enrolled in home~     visiting programs.~   "
182535|NCT01175590|"~     The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic~     suspension, 0.6%) compared to vehicle.~   "
182536|NCT01175577|"~     The primary purpose of this study is to compare the change in blood carotene concentration~     between a food-based versus nutritional supplement-based intervention. This study will~     randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural,~     mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood~     carotene levels will be measured before and after 28 days of supplementation. Preliminary~     data will also be collected on several biomarkers associated with vascular inflammation and~     endothelial dysfunction. These biomarkers will be measured before and during a fast food~     control meal at the beginning and end of the intervention period.~   "
182537|NCT01175564|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics after a~     single and repeated oral doses of TC-5214 (S-mecamylamine) in healthy male Japanese subjects.~   "
182538|NCT01175551|"~     Racism and health care system distrust are potent stressors and may be associated with~     preterm birth (PTB). Additionally, cervical shortening is a common pathway leading to PTB.~     This study is enrolling a prospective cohort of pregnant women. The study assesses racial~     discrimination, health care system distrust, and cervical change using 2 questionnaires,~     exam, and protein levels in cervical vaginal fluid and maternal serum.~   "
182539|NCT01175538|"~     To assess the effects of lactulose for the prevention of first episode of altered sensorium~     (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.~   "
182540|NCT01175525|"~     Mastocytes were proven to have a central rule in their development of the lipoid plaque of~     the vascular system. Mastocytes also has an important role in the stabilisation of the plaque~     in the building of the brain barrier. Different animal studies show that the inhibition of~     the mastocyte activity decreases significantly the risk of secondary bleeding post ischaemic~     stroke.It was also shown that post stroke inflammation process was also blocked by the~     inhibition of mastocytes.Other studies showed up to 100% decrease in the brain barrier~     disruption and post stroke oedema, after treatment with mastocyte inhibitors.~      Cromolyn is a synthetic drug which has an anti-allergic effect by inhibition of the~     mastocytes. This drug is a well known,safe drug and is the main sub-substance that was used~     in the previously mentioned studies.~   "
182541|NCT01175512|"~     The investigators will develop a measure of endogenous opioid tone that might serve as a~     biological marker for drive for palatable food. Using a 'naltrexone probe,' the investigators~     will assess whether individual response to one dose of an opioid receptor antagonist,~     naltrexone, is related to non-homeostatic eating in non-pregnant women.~      Hypothesis 1: Naltrexone Response will be related to non-homeostatic eating.~      Hypothesis 2: Response profiles to the 25 mg dose will be slightly less in magnitude than the~     50 mg dose. However, responses will be similarly related to non-homeostatic eating measures.~      Hypothesis 3: Response to naltrexone will be highly stable within individuals across time, in~     the absence of an intervention.~   "
182542|NCT01175499|"~     This study will compare TNFE-NBI and biopsy, with DRE and biopsy for the diagnostic~     evaluation and staging of patients with suspicious UADT lesions. All patients enrolled in the~     study will undergo TNFE-NBI with biopsy of suspicious lesions prior to planned regular~     clinical care (DRE). Biopsies will be evaluated by standard clinical methods for patient~     diagnoses and care. As the current standard of care, if all biopsies for a given patient are~     non-malignant, a 3 month office visit will be arranged to evaluate and determine the need for~     further intervention. At the end of study enrollment both sets of biopsies will be~     re-evaluated in a blinded fashion by the surgical pathologist. Study assessment of malignant~     vs. non-malignant (benign) pathology will be used to see whether both tests tended to agree~     on diagnoses.~   "
182578|NCT01175031|"~     The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy~     of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended~     clinical polysomnography (PSG) in identifying breathing events in participants previously~     diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes~     respiration (CSR), or obstructive sleep apnea (OSA).~   "
189831|NCT01079754|"~     This study aims to compare the efficacy of 0.05 mg and 0.1 mg spinal morphine in reducing~     postoperative morphine requirement in patients undergoing vaginal hysterectomy with/without~     anterior and posterior vaginoplasty.~   "
182543|NCT01175486|"~     Objectives:~      Thiazolidinediones (TZDs) are insulin sensitizers that decrease plasma glucose in type 2~     diabetic patients. Thiazolidinediones can cause fluid retention and peripheral edema in~     diabetic patients, and the systematic fluid retention can be manifested as diabetic macular~     edema (DME). The overall goal of this study is to examine the effects of thiazolidinediones~     on the diabetic retinopathy and nephropathy.~      Study design:~      This is a prospective, randomized, open-labeled, controlled design to assess the effects~     thiozolidinediones on the diabetic retinopathy and nephropathy. The investigators will~     recruit 300 type 2 diabetic patients without significant retinopathy, nephropathy and~     cardiovascular disease. Inclusion criteria are type 2 diabetes, age between 30-80 years old,~     with microabluminuria, no significant retinopathy, on submaximal dose of sulphonylureas and~     metformin treatment, and A1C between 7-9%. Exclusion criteria are on insulin treatment,~     significant retinopathy and significant nephropathy. Patients with cardiovascular diseases,~     malignancy, pregnancy, in acute intercurrent illness, congestive heart failure, myocardial~     infarction, received PCI or CABG. All subjects will receive EKG and CXR before randomization.~      These subjects will be randomized equally to 3 groups: acarbose, rosiglitazone and~     pioglitazone. The investigators will follow up for 6 months to investigate the short-term~     effects and 5 years to evaluate the long-term outcomes. The primary study end point of~     short-term study will be the macular thickness changes measured by optical coherence~     tomography, the changes in the level of urinary albumin-to-creatinine ratio, circulating~     metabolic parameters and adipocytokines during thiozolidinediones treatment. Secondary end~     point will be fasting blood glucose, A1C levels, development of clinically significant~     macular edema, serum creatinine change in patients with no history of diabetic retinopathy~     and nephropathy at baseline.~      The primary study end point of long-term study will be the development of clinically~     significant macular edema and the time from the base-line visit to the first detection of~     overt nephropathy. Secondary end points include the development of greater than moderate~     NPDR, the time to the first event of the time from the base-line visit to a doubling of the~     serum creatinine concentration, end-stage renal disease, or death.~   "
182544|NCT01175473|"~     The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010),~     in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks~     of treatment.~      The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide,~     in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose~     concentration curve (AUC) after a standardized breakfast at Week 4.~      The secondary objectives are to assess the effects of lixisenatide on the maximum PPG~     excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma~     concentrations following a standardized breakfast, 24-hour profile of plasma glucose,~     glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY [PYY3-36] and~     oxyntomodulin); and to assess the clinical and laboratory safety profile.~   "
182545|NCT01175460|"~     Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30~     fractions,and concurrent with s-1 and nedaplatin.~   "
182546|NCT01175447|"~     Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30~     fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70,~     and 80 mg/m(2)/day.~   "
182547|NCT01175434|"~     The goal of this new translational project is to test the feasibility and effectiveness of~     implementing school-based directly observed therapy of preventive asthma medications in a~     real-world setting, using state-of-the-art web-based technology for systematic screening,~     electronic report generation, and communication between nurses, caregivers, and primary care~     providers. With the use of a novel method to improve adherence and subsequently reduce~     morbidity, the investigators hypothesize that this novel adaptation of school-based asthma~     care will; 1) be feasible and acceptable among this population and among school and community~     stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and~     emergency room / urgent care use for asthma care). The investigators anticipate that~     enhancing preventive healthcare for young urban children with asthma through partnerships~     with the schools using a novel technology will yield improved health, prevention of~     suffering, decreased absenteeism from school, and reduced healthcare costs.~   "
182548|NCT01175421|"~     Purpose:~      In a retrospective cohort the investigators will validate, the goodness of a multidimensional~     index to classified the severity of patients with sleep disordered breathing that has been~     previously developed in a prospective longitudinal cohort.~   "
182549|NCT01175408|"~     Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In~     order to prevent complications, patients need to monitor and control their blood sugar~     levels. In addition, they may need to have an ongoing communication with their doctor in~     order to modify treatment. In this study the investigators wish to compare the benefits of~     continuous glucose monitoring system (CGMS) to an internet-based glucose monitoring system~     (IBGMS). The investigators also want to determine whether the frequency of blood glucose~     testing affects blood glucose control and to see whether the benefits of CGMS and IBGMS are~     independent of testing frequency.~   "
182550|NCT01175395|"~     The primary purpose of this study is to assess the safety & tolerability of an~     investigational drug 20089 TA (6.9 mg or 13.8 mg) when used adjunctively with Lucentis 0.5 mg~     in subjects with sub-foveal neovascular AMD.~   "
182551|NCT01175382|"~     The primary aim of this project is to evaluate the effectiveness of combined behavioral +~     drug therapy compared to behavioral treatment alone and drug therapy alone as a way to~     improve outcomes in the treatment of OAB symptoms in men. We hypothesize that combined~     therapy will result in better outcomes than either behavioral or drug therapy alone. The~     second aim is to compare two methods of implementing combined therapy: simultaneously as~     initial therapy vs. stepped therapy, in which therapies are combined following initial~     behavioral or drug therapy alone. The third aim is to examine the costs and~     cost-effectiveness of combined behavioral + drug therapy compared to behavioral or drug~     therapy alone.~   "
182552|NCT01175369|"~     Asthma is the most common chronic illness of childhood, and hospitalization rates are~     increasing. In the US, impoverished children and children from minority ethnic and racial~     backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood~     Institute (NHLBI) guidelines recommend daily preventive medications for all children with~     mild persistent to severe persistent asthma, studies indicate that many children in the US~     who should receive preventive medications are not receiving them. The overall goal of this~     project is to target an ethnically diverse population of inner-city schoolchildren with~     asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that~     children receiving a comprehensive school-based intervention will experience less~     asthma-related morbidity compared to children receiving usual care. Our comprehensive~     school-based intervention consists of both administration of recommended preventive asthma~     medications in school (with dose adjustments according to NHLBI guidelines) and an~     environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children.~     Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who~     receive the school-based intervention with ETS reduction will experience less asthma~     morbidity than those who receive usual care.~   "
182553|NCT01175356|"~     This clinical trial is studying induction therapy followed by meta-iodobenzylguanidine (MIBG)~     labeled with iodine-131 and chemotherapy in treating patients with newly diagnosed high-risk~     neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy~     with isotretinoin. Radioisotope therapy, such as MIBG labeled with iodine-131, releases~     radiation that kills tumor cells. Drugs used in chemotherapy, such as cisplatin, etoposide,~     busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. A peripheral stem cell transplant can~     replace blood-forming cells that are damaged by MIBG labeled with iodine-131 and~     chemotherapy.~   "
182554|NCT01175343|"~     This phase II trial is studying the side effects and how well RO4929097 works in treating~     patients with recurrent and/or metastatic epithelial ovarian cancer, fallopian tube cancer,~     or primary peritoneal cancer. RO4929097 may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
182555|NCT01175330|"~     The purpose of this study is to evaluate efficacy of Polyunsaturated Fatty Acid for the~     prevention of Atrial Fibrillation and anti-inflammatory effects in patients after CABG~     surgery~   "
182556|NCT01175317|"~     58 patients undergoing surgery of the large bowel are divided into two groups. The control~     group will receive standard care. The intervention group will receive standard care plus~     optimization of the blood circulation based on in- or decrease of the output of the heart.~     Between group differences are measured primarily by markers of intestinal damage in plasma~     and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the~     gut).~      The investigators hypothesize that the intervention group will have less intestinal damage,~     improved blood supply to the bowel and improved recovery of the operation compared to the~     control group.~   "
182557|NCT01175304|"~     The purpose of this study is the description of sleeping habits in a working population in~     the investigators health care environment, analyzing the prevalence of daytime sleepiness and~     symptoms compatible with the sleep apnea syndrome and finally to analyze predictors of~     daytime sleepiness.~   "
182558|NCT01175291|"~     The purpose is to study the efficacy (effectiveness) of a new drug, MK-0646, in metastatic~     colorectal cancer. MK-0646 is an investigational or experimental anti-cancer agent that has~     not yet been approved by the U.S. Food and Drug Administration (FDA) for use in metastatic~     colorectal cancer or any other disease.~      This study will assess whether adding MK-0646 to an FDA-approved standard of care~     chemotherapy improves participants' duration of progression-free survival. MK-0646 is~     believed to inhibit the receptor of a protein called IGF-1 (Insulin-like Growth Factor) which~     is thought to contribute to cancer development and growth. However, there is no guarantee~     that MK-0646 will slow cancer development and growth.~      Other purposes of this study include:~        -  looking at the safety and tolerability of MK-0646~        -  comparing MK-0646 + standard of care chemotherapy with placebo + standard of care~          chemotherapy (placebo is a substance that looks like an active drug but has no active~          ingredient) The standard of care chemotherapy in this study is called FOLFOX 7. FOLFOX 7~          includes the drugs oxaliplatin with leucovorin, 5-Fluorouracil (5-FU), and bevacizumab.~   "
182559|NCT01175278|"~     The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the~     patient's fracture using balloons and bone cement) compares to non-surgical treatment in~     reducing vertebral compression fractures while providing pain relief and improved function~     and quality of life.~   "
182560|NCT01175265|"~     Conventional pulmonary rehabilitation programs improve exercise tolerance, peripheral muscle~     strength, and health related quality of live but not pulmonary function in patients with~     chronic obstructive pulmonary disease (COPD). The role of breathing retraining techniques in~     the rehabilitation of patients with COPD remains unclear. The hypothesis to be tested in this~     study is that pulmonary function, cardio-pulmonary exercise capacity, health related quality~     of life and cardiac autonomic modulation of patients with COPD who undergo pulmonary~     rehabilitation plus breathing retraining will be better than that of patients undergoing a~     conventional pulmonary rehabilitation.~   "
182561|NCT01175252|"~     This study aims at collecting data to obtain baseline incidence and monitor trends over time~     in hospitalizations and deaths from all cause gastroenteritis in children <5 years of age,~     before and after implementation of Rotarix™ universal mass vaccination in Brazil.~   "
182562|NCT01175239|"~     X-linked severe combined immunodeficiency (SCID-X1) is an inherited disorder that results in~     failure of development of the immune system in boys. This trial aims to treat SCID-X1~     patients using gene therapy to replace the defective gene.~   "
182563|NCT01175226|"~     This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on~        -  shortening the length and reducing the symptoms of human rhinovirus infection (also~          known as the common cold),~        -  controlling asthma symptoms, and~        -  lowering the risk of asthma symptoms worsening in subjects with asthma.~   "
182564|NCT01175213|"~     The original purpose of the study was to assess the long-term safety, tolerability, and~     practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution~     (IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with~     Primary Immunodeficiency Diseases (PID) who had completed Baxalta (formerly Baxter) Clinical~     Study Protocol No. 160603.~      Following a discussion with the FDA at the end of July 2012, all participants still active in~     the study stopped treatment with rHuPH20 to assure safety of the participants participating~     in the study and went into a safety follow-up.~      During this safety follow-up period, participants underwent either SC treatment with IGSC,~     10% or intravenous (IV) treatment with Immune Globulin Intravenous (Human) (IGIV), 10%. The~     IV or SC administration route was at the discretion of the participant and the investigator.~   "
182565|NCT01175200|"~     This study will establish the optimal therapeutic strategy for patients with a coronary~     artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring~     co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for~     treatment/prevention of GI ulceration.~   "
182566|NCT01175187|"~     Intrapartum fever associated with epidural anesthesia is caused by non infectious causes~     therefore without histological findings~   "
182608|NCT01174628|"~     The purpose of this study is to evaluate the long-term impact of Pulmonary Embolism (PE) on~     heart and lung function, quality of life, ability to work, symptoms of breathlessness and~     functional status of patients one year after their initial diagnosis and treatment for PE~   "
182567|NCT01175174|"~     Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute asthmatic~     attack presenting to the ED.~      Background:~      Children under the age of 5 years have the highest hospitalization rate of asthma. The most~     common causes of acute exacerbations of asthma requiring urgent medical care are viral~     respiratory infections. Most of these children < 6 y old are not atopic.~      The inflammatory response to these mostly viral-induced asthmatic attacks is not well~     characterized in the literature. Moreover it is not known whether different kind of~     inflammatory responses exist in this population and how this correlate to clinical outcomes~     and clinical phenotypes in preschool children presenting ti the ED with acute asthmatic~     attack.~      Therefore, the purpose of the present study is to:~      Investigate the characterization of induced sputum cytology in preschool children with acute~     asthmatic attack and whether there is correlation between specific sputum cytology and~     response to therapy and to investigate airways hyper-responsiveness to adenosine~     5'-monophosphate and to metacholine in pre school children 2-6 y old at 2 weeks and at 3~     month following acute asthmatic exacerbation and look for correlation with response to~     treatment and sputum cytology. Clinical phenotypes of this patient population will also be~     investigated.~   "
182568|NCT01175161|"~     The purpose of this non-blinded randomized clinical trial is to pilot the design of a~     randomized clinical trial to be conducted in Malawi to investigate immediate postpartum~     insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to~     placement at the 6-week postpartum visit.~      The investigators hypothesize that it will be feasible to enroll 140 women into this study,~     and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.~   "
182569|NCT01175148|"~     Atorvastatin for prevention of acute GVHD~   "
182570|NCT01175135|"~     This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of~     acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study~     will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for~     PF-02545920 compared to risperidone and placebo treatment.~   "
182571|NCT01175122|"~     In recent years, influenza viruses that have traditionally infected animals have infected~     humans as well. The H2N3 influenza virus, which first appeared in pigs in the Midwest United~     States in 2006, may pose a potential health concern to humans. This study will evaluate the~     safety of and immune response to a vaccine designed to protect people from the H2N3 influenza~     virus.~   "
182572|NCT01175109|"~     This is a multi-center study to assess the safety and to determine the maximum tolerated dose~     of the combination of imatinib and LBH589 in patients with newly diagnosed and recurrent~     chordoma. For the recurrent population, those patients that do not require immediate surgical~     resection will be eligible. Patients will be treated with 4 cycles, followed by surgical~     resection if possible. If indicated, surgery may take place prior to the completion of 4~     cycles.~   "
182573|NCT01175096|"~     RAD001 continues to be investigated as an anticancer agent on new indications such as~     neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and~     lymphoma based on its potential to act:~        -  directly on the tumor cells by inhibiting tumor cell growth and proliferation~        -  indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent~          inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced~          proliferation of endothelial cells)~      A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced~     carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and~     protein translation and the finding that somatostatin-induced growth arrest is mediated in~     part by inhibition of the PI3K pathway (Charland, et al. 2001).~      The present study is designed to collect safety/tolerability data and evidences for efficacy~     of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor~     in Chinese patients.~   "
182574|NCT01175083|"~     The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK~     Biologicals' pneumococcal conjugate vaccine GSK1024850A.~      Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib~     and OPV vaccines.~   "
182575|NCT01175070|"~     Diabetic macular oedema (DME) is one of the leading causes of blindness in the United~     Kingdom's working population. It affects the macula, which lies at the centre of the retina,~     at the back of the eye. Damage to the macula can occur either because the blood supply is~     reduced (ischaemic DME), or because the blood vessels are leaking excessively (exudative~     DME).~      A chemical called vascular endothelial growth factor (VEGF) may underlie some of the~     abnormalities seen in DME. Studies have shown that VEGF encourages leakage of fluid from~     blood vessels and increases the stickiness of white blood cells. When white blood cells are~     sticky they can attach to blood vessel walls. This may cause small blood vessels to block,~     and lead to ischaemia.~      Laser treatment often helps to stabilise exudative DME, but there is currently no recognised~     treatment for ischaemic DME. Macugen (pegaptanib), a drug that inactivates VEGF, has been~     tried and found to be of benefit in treating exudative DME. Since VEGF promotes ischaemia, it~     is possible that Macugen will also prove to be beneficial for ischaemic DME. This has not~     been tested before.~      A healthy macula is essential for good vision. The innermost area of the macula, the foveal~     avascular zone (FAZ), is the most important part. The FAZ is enlarged when it is ischaemic.~     This is a pilot study to assess whether Macugen can reduce the size of the FAZ in ischaemic~     DME. The investigators will also assess whether it can reduce retinal thickness and improve~     vision in ischaemic DME. Thirty patients will be involved in the study for thirty weeks each.~     They will have their eyes examined and receive an injection of Macugen into the eye every 6~     weeks. The study is taking place in the Oxford Eye Hospital and is being funded by Pfizer,~     the company that makes Macugen.~   "
182576|NCT01175057|"~     In this study feasibility of the MeDiNa concept is looked at, which means telemedical~     services for homely rehabilitation. With the help of microsystems technology, the relevant~     vital signs are measured at the patient`s home, then transmitted to the MeDiNa- Homebox-~     Tablet PC (by bluetooth) and then transferred into a central database, the MeDiNa eHealth-~     portal (by HSDPA, UMTS). These parameters can be continuously monitored by authorized network~     participants such as the family doctor or the patients themselves. In future, beyond cost~     advantages this will help to supervise risk patients or inspire patients to take more care of~     their health during homely rehab.~   "
182579|NCT01175018|"~     Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many~     patients die early during the course, and those who survive are at risk for dying late from~     adverse cardiac remodeling and heart failure.~      The initial ischemic damage to the myocardium initiates an intense inflammatory response in~     promoting further cardiac dysfunction and heart failure. The investigators propose that an~     antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory~     response and lead to a more favorable cardiac remodeling process.~   "
182580|NCT01175005|"~     Procalcitonin (PCT) is one of many inflammatory markers which rises in response to infection.~     Many studies have shown this marker to be more indicative of a patient's clinical course in~     comparison to other inflammatory markers, such as Erythrocyte Sedimentation Rate (ESR) and C~     reactive protein (CRP), when assessing a patient's risk for serious infection. A particular~     population with potential for serious infection is that of the patient with fever and a~     central line, most often secondary to an oncologic disease. These patients are often~     neutropenic and unable to fight off infection, thereby rendering them extremely vulnerable to~     rapid declines in clinical status. By identifying a level of procalcitonin which is~     significant as a threshold for serious bacterial infection, the investigators can very early~     on identify the sickest patients and those who could potentially have a worse clinical course~     and/or outcome.~      The primary study goal is to identify whether a level of procalcitonin exists above which~     rates of bacteremia or serious bacterial infections in patients with fever and a central line~     exist. The investigators will try to determine if levels of PCT correlate with bacterial~     infection in line sepsis in the specific population of patients who most often have a central~     line secondary to an oncologic process. The investigators proposed this theory since peak~     values of PCT have been shown to be elevated in acute settings making it a useful tool in~     this particular population.~   "
182581|NCT01174992|"~     The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an~     adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight~     closure.~   "
182582|NCT01174979|"~     This trial is a randomized, double blind, placebo controlled study on patients suffering from~     inner ear diseases with tinnitus as a principal symptom.~      The study will investigate the transtympanic treatment with a 1,5 % caroverine solution.~      Each patient will undergo treatment for 2 cycles of 48 hours each.~   "
182583|NCT01174966|"~     The lack of subcutaneous partial pressure of oxygen (PO2) rise in response to high fraction~     of inspired oxygen (FiO2), called the oxygen challenge test (OCT), was associated with~     higher morbidity and mortality in human subjects. Patients had negative O2 challenge test~     results, indicating that flow-dependent O2 consumption might have been present. Recent~     reports using the noninvasive transcutaneous PO2 (PtO2) and transcutaneous partial pressure~     of carbon dioxide probes have observed a relationship between low oxygen challenge test~     values to mortality and organ failure. The OCT values provides an accessible noninvasive~     method of detecting early shock.~      To date,these studies of OCT in the ICU patients are rarely. No one has quantified OCT to CI,~     DO2I、ScvO2.~      This study explored:~        1. relationship between patient factors, hemodynamic variables, PtO2, and OCT to mortality;~        2. relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI, DO2,~          ScvO2.~   "
182584|NCT01174953|"~     The purpose of this study is to study the molecular effects of the chemopreventative agent,~     finasteride, in combination with dietary soy supplementation in patients at high risk for the~     development of prostate cancer. Also, the investigators intend to create a large database~     with health information from men who are at high risk of developing prostate cancer, along~     with serum and tissue samples from those patients who are willing to provide tissue and serum~     samples.~   "
182585|NCT01174940|"~     To study the effect of ECP with Uvadex® in conjunction with a standard myeloablative~     conditioning regimen on the incidence of acute and chronic GvHD in patients undergoing an~     allogeneic related or unrelated BMT or PBSC transplant, for treatment of hematologic or~     lymphoproliferative malignancies.~   "
182586|NCT01174927|"~     The aims of the study are to investigate the effects of diacetylmorphin (heroin) on brain~     using functional magnetic resonance imaging (fMRI), coupled with measurements of cortisol~     concentrations and neurophysiological stress parameters during the presentation of emotional~     and cognitive stimuli in patients with heroin dependence.~   "
182587|NCT01174914|"~     In the vast majority of those infected with HIV virus who are untreated, there is~     deterioration in immune health over a period of months or years inevitably leading to~     full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if~     started before a certain degree of progression occurs and has saved millions of lives. The~     investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved~     medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably to~     ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.~   "
182588|NCT01174901|"~     Headache is a common symptom, and patients often seek medical attention at emergency~     departments due to headaches.~      The aim of the CoHead Study is to find out if it is possible by measuring copeptin, a marker~     of stress in the blood, to find out which patients have simple headaches and which patients~     have dangerous headaches that are the symptom of an underlying disease and need further~     investigation and treatment.~      Copeptin is a marker for physical stress and has been tested in patients with stroke, heart~     attack and pneumonia. In all these illnesses, the patients with the most serious forms had~     the highest levels of copeptin, while the ones with only mild presentation or no affection at~     all had the lowest levels of copeptin.~      The investigators expect to show the same in patients with headaches.~   "
182589|NCT01174888|"~     RATIONALE: Bortezomib and midostaurin may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone~     hydrochloride, etoposide, and cytarabine, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and~     midostaurin together with combination chemotherapy may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with midostaurin with or without combination chemotherapy in treating patients~     with relapsed or refractory acute myeloid leukemia.~   "
182590|NCT01174875|"~     This study aims to test the following two hypotheses in women recruited in early pregnancy~     and whose children will be followed up till at least 9 years of age.~        -  Epigenetic changes in conceptual tissues obtained at birth reflect the environment that~          the fetus was exposed to during development.~        -  The pattern of epigenetic marks in gene promoters obtained from DNA in birth tissues,~          together with genotype, phenotype, and environmental exposures, can be utilized to~          assess how the perinatal environment affects subsequent metabolic, neurodevelopmental~          and other phenotypes.~   "
182591|NCT01174862|"~     In patients undergoing coronary artery bypass graft (CAGB) surgery, aspirin is commonly~     prescribed to prevent graft thrombosis and myocardial ischemia. However, there are still a~     significant number of grafts occluding in the postoperative period. This is partly attributed~     to reduced aspirin responsiveness, also called aspirin resistance. At the moment, no~     standardized definition or laboratory test is available to quantify aspirin resistance, and~     strong platelet reactivity in laboratory tests is not necessarily associated with increased~     thrombotic events. However, there is increasing evidence that reduced aspirin responsiveness~     in platelet function analyzers is associated with adverse long-term outcome and higher~     incidence of major adverse events in patients with stable coronary artery disease and in~     patients undergoing percutaneous coronary intervention. In patients undergoing coronary~     artery bypass graft surgery, the predictive value of a laboratory finding of reduced aspirin~     responsiveness remains unclear.~      Therefore, the aim of this study is to prospectively evaluate whether the pre- and/or~     postoperative laboratory finding of reduced aspirin responsiveness defined by MultiplateTM~     platelet function analyzer is associated with higher incidences of adverse outcome after 30~     days and 12 months in patients undergoing CABG surgery.~   "
182592|NCT01174849|"~     The purpose of this study is to determine whether an early schedule of a combination of three~     doses of PHiD-CV and one dose of PCV13, is superior to three doses of either PCV13 or~     PHiD-CV.~   "
182593|NCT01174836|"~     Hypothesis: The majority of Emergency physicians and patients do not feel that specific~     informed consent should be obtained for ED CT scans.~      Secondary Hypothesis: Emergency attending physicians and residents will have similar~     attitudes about CT scan consent issues. Physician attitudes toward obtaining consent for CT~     scans will change after an educational program about the associated risks.~   "
182594|NCT01174823|"~     The purpose of this study is to study the safety and efficacy of bepotastine besilate~     ophthalmic solution in allergic conjunctivitis patients.~   "
182595|NCT01174810|"~     Exenatide is a licensed, safe and effective treatment for patients with Diabetes mellitus.~     Laboratory work has shown strong, reproducible evidence that this drug has beneficial~     disease modifying effects when given to animals with a range of experimental models of~     Parkinson's disease (PD). This project aims to make an initial evaluation of possible~     benefits of Exenatide among patients with moderate symptoms of PD. The drug will be given as~     a twice daily 10microgram injection under the skin in a similar way to one of the~     conventional symptomatic treatments for PD (Apomorphine).~      Forty patients with moderate symptoms of PD will be recruited and randomised to receive~     Exenatide injections twice daily, or to act as controls in this open label trial. Detailed~     assessments will be made of all patients at baseline and periodically for a total of 14~     months. The primary outcome measure will be the change between baseline and follow up, in the~     severity of a validated PD assessment scale (the UPDRS part 3 motor score) after an overnight~     period free of conventional PD medication. Secondary measures will include adverse event~     reports, self completed questionnaires, and blood test results. Aside from these assessments,~     all patients will continue their regular PD medications throughout the trial with adjustments~     made only according to clinical need.~      In a subgroup of patients (n=10), brain scans that assess the severity of PD, will be~     performed at both baseline and follow up to help understand possible mechanisms of action of~     Exenatide.~   "
182596|NCT01174797|"~     MTWA-CAD is a feasibility study designed to evaluate Microvolt T-Wave Alternans (MTWA)~     testing for the purpose of detecting active ischemia in patients with known or suspected~     coronary artery disease (CAD). MTWA is a subtle, alternating pattern in the T wave portion of~     the surface electrocardiogram (ECG) that is associated with increased risk of ventricular~     tachyarrhythmias and sudden cardiac arrest (SCA).~   "
182597|NCT01174784|"~     This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a~     single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated~     during the index procedure through 30-day follow-up.~   "
182598|NCT01174771|"~     Drug therapy of atypical parkinsonism is generally considered either ineffective or minimal~     1. Therefore, there is an urgent need to find alternative therapies to treat atypical~     parkinsonian disorders. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive~     tool that modulates cortical excitability with minimal discomfort and holds therapeutic~     promise in treating neurological and psychiatric disorders.~      The basal ganglia-thalamocortical circuits that are affected in Progressive Supranuclear~     Palsy (PSP) and Corticocbasal Ganglionic Degeneration (CBGD) are likely structurally and~     functionally segregated. The 'motor' circuit is implicated in parkinsonian akinesia and~     hypokinesia; a 'prefrontal' circuit is implicated in working memory and mood regulation, and~     linked with non-motor symptoms such as depression and apathy. In this proposal, we~     characterize motor and prefrontal network dysfunction in PSP and CBGD patients, and propose~     that high-frequency and low-frequency rTMS directed over separate motor and prefrontal~     cortical targets of each network may show specific and selective beneficial effects on motor~     vs. cognitive function in PSP and CBGD patients, respectively. Quantitative motor outcome~     measures include timed finger tapping tasks. Quantitative cognitive outcome measures comprise~     a visual analogue scale (VAS).~      If successful, this pilot study will provide proof of principle data to suggest potential~     benefits for rTMS in PSP/CBGD patients, and provide sufficient data and experience to support~     future PSP/CBGD studies that include the use of rTMS to investigate the pathophysiology of~     motor and non-motor features of PSP and CBGD patients.~   "
182622|NCT01174446|"~     The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK)~     parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in~     previously treated patients (PTPs) with severe and moderately severe hemophilia B.~   "
182623|NCT01174433|"~     To assess the safety and feasibility of the use of the Tryton bifurcation coronary stent~     system for the treatment of single de novo bifurcation lesions in native coronary arteries.~   "
182599|NCT01174758|"~     Developing technology to increase efficiency and decrease cost of clinical trials. The~     longterm objective of this project is to use new technologies to sensitively measure,~     automatically analyze and efficiently manage clinical trial data for Parkinson's disease (PD)~     and other neurological disorders. This project will focus on developing objective measures of~     balance and gait because mobility disability and falls are so critical for quality of life in~     PD. Clinical movement disorders experts will team up with a local start-up business to~     develop, produce, and test a novel clinical balance and gait assessment tool, the~     instrumented Timed Up and Go Test (iTUG) for patients with Parkinson's disease. Balance and~     gait will be measured with wireless sensors worn on the wrists, ankles and trunk while~     patients stand up from a chair, walk, turn and return to sit on the chair. Accelerations and~     angular velocities from the sensors will be automatically transmitted, stored, analyzed, and~     displayed as Mobility Scores on a remote, centralized computer, along with other patient~     information important for clinical trials. Specifically, this proposal will 1) create a~     commercially-available, clinical trial system that includes completely wireless sensor~     technology, a custom-made, user-friendly, computer interface and efficient data management~     server; 2) develop a mobility score from many potential balance and gait measures and 3)~     compare the sensitivity of the iTUG compared to traditional clinical tests of balance to~     changes in PD due to antiparkinson medication. By providing a more sensitive, accurate, and~     comprehensive method to quickly test and analyze balance and gait, clinical trials to improve~     mobility in patients with Parkinson's disease and other neurological disorders will be~     significantly more effective and efficient. This will permit clinical trials in Parkinson's~     disease to be completed with fewer subjects, shorter duration, and less cost.The current~     project will accelerate the development of new therapies for Parkinson's disease.~   "
182600|NCT01174732|"~     This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover~     and dose-ranging design. This study aims to evaluate the efficacy and initial safety~     profiles, and to identify the optimum dose of A006, from a select dose-range for future~     clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy,~     adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to~     Screening.~   "
182601|NCT01174719|"~     The aim of the study is to compare three different regimens for volume replacement during~     cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL).~      Main Outcome parameters: chest tube drainage and coagulation parameters. The investigators~     hypothesis is that HES is as safe as Albumin, however less expensive. Whether RL is an even~     less expensive and as safe alternative has to be shown.~   "
182602|NCT01174706|"~     The main objectives of this research are:~        1. To identify factors that influence medication adherence rates in Emergency Department~          (ED) patients.~        2. To measure the effects of alternative information prescriptions on medication adherence~          rates of ED patients.~        3. To measure the effects of alternative information prescriptions (IRxs) on health and~          service utilization.~   "
182603|NCT01174693|"~     The purpose of this study is to compare the preventive effect of stroke between triflusal and~     clopidogrel in ischemic stroke patient based on the cytochrome P450 2C19 (CYP2C19)~     polymorphism.~   "
182604|NCT01174680|"~     The register study CGM@CAD will examine whether cardiogoniometry can provide additional~     information concerning the indication for a diagnostic coronary angiography and if so, which~     additional value it has. Therefore, an additional cardiogoniometry will be carried out in~     consecutive patients who have been diagnosed with myocardial ischemia by means of established~     methods (exercise ECG, stress echocardiography, myocardial scintigraphy, or stress-MRT) and~     for whom an intracardiac catheter examination is regarded as indicated. The results of the~     different methods - particularly the results of the exercise ECG and the cardiogoniometry -~     will be checked against the results of the invasive examination as gold standard and the~     discharge diagnosis with regards to any correlation.~   "
182605|NCT01174667|"~     The aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues~     in the low back in a group of patients with chronic low back pain treated with massage to a~     control group of non-treated patients.~      It is hypothesized that on average, soft tissue thickness in the lumbar region will change in~     the group receiving massage compared to the control group.~   "
182606|NCT01174654|"~     Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk~     sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and~     some authorities have advocated methamphetamine treatment as an HIV prevention strategy.~     However, methamphetamine interventions have not been evaluated in controlled trials, nor have~     they been implemented and assessed outside of substance abuse treatment programs. This~     application proposes preliminary investigations to adapt a methamphetamine treatment~     intervention previously associated with decreased sexual-risk taking among MSM for use as an~     early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be~     enrolled in a randomized controlled trial of contingency management (CM) versus no~     intervention. CM participants will have their urine tested for methamphetamine 3 times weekly~     for 12 weeks, and will receive vouchers of escalating value when their urines test negative;~     vouchers will be withheld when participants' urines test positive for methamphetamine or~     participants miss urine testing visits. All participants will undergo urine methamphetamine~     testing and audio-computer assisted self-interviews on sexual behavior and substance use at~     baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis,~     rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and~     6 month follow-up. The study will determine how often MSM will initiate and complete the~     early intervention, and will longitudinally measure unsafe sexual behaviors among~     intervention and control participants. Study results will determine the feasibility of~     instituting and studying CM as an early intervention; define whether the intervention is~     sufficiently promising to justify a larger, definitive randomized controlled trial; and will~     provide estimates for defining the number of participants such a trial would require.~   "
182607|NCT01174641|"~     Problems in attention can affect around 40% of stroke survivors and are associated with poor~     recovery of function. This project will provide the largest scale and most detailed~     examination to date of whether problems in attention after stroke can be remediated through~     direct brain stimulation. In Part 1 of the project the investigators will use two forms of~     direct brain stimulation (neural inhibition) to try and balance activity across the two sides~     of the brain following a stroke to one side. The investigators will assess whether each form~     of stimulation leads to an improvement in attentional functions, as well as to wider~     improvements in other cognitive abilities and to activities of everyday living. Performance~     will be tested immediately post remediation and on longer-term follow-up, and performance of~     the two intervention groups will be assessed against data the investigators have collected~     from a large-scale screen of cognitive impairments and recovery of function under standard~     treatment conditions. In Part 2 of the project the investigators will take the most promising~     intervention from Part 1 and the investigators will use magnetic resonance imaging (MRI) to~     determine the brain changes that are linked to the recovery of attentional functions. The~     investigators will test whether recovery is linked to a change in the balance of activation~     within the two hemispheres of the brain, and whether there are associated structural changes~     in cortical tissue and fibre tracts. The project will evaluate whether neural inhibition can~     improve attentional functions in particular, and cognitive abilities and everyday activities~     more generally, in stroke survivors. It will also provide novel information on how recovery~     of function comes about within the brain.~   "
182609|NCT01174615|"~     The collection of Blood and/or Bone Marrow from patients with blood disorders, blood cell~     malignancies and associated conditions will serve as a convenient and comprehensive source of~     tissue to give us further information about the differences between normal blood cells and~     blood cells of affected individuals. This will be an invaluable asset for understanding the~     biology of blood disorders. The collected samples will be used by investigators for studies~     including immunology, molecular biology and genetics to name a few.~   "
182610|NCT01174602|"~     Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa~     improve their eating behavior.~   "
182611|NCT01174589|"~     The primary purpose of this study is to illustrate whether there is a difference in the 6~     minutes walking test in patients with hip fractures who have received 6 vs. 12 weeks of~     physical training after discharge from hospital.~   "
182612|NCT01174576|"~     The purpose of the study is to investigate whether caffeinated and decaffeinated coffee~     consumption has acute effects on subjective appetite feelings, energy intake and biochemical~     markers related to appetite, inflammation and glucose metabolism compared to water~     consumption.~   "
182613|NCT01174563|"~     This open-label, single arm study will assess the correlation between Tarceva~     (erlotinib)-induced rash and efficacy in patients with inoperable, locally advanced,~     recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for~     advanced disease. Patients will receive Tarceva at a dose of 150 mg daily orally, with dose~     adjustments according to protocol depending on toxicity. Anticipated time on study treatment~     is until disease progression occurs.~   "
182614|NCT01174550|"~     A prospective multicenter imaging study for evaluation of chest pain. Objective is to~     determine whether an initial non-invasive anatomic imaging strategy with coronary CT~     angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for~     coronary artery disease relative to an initial functional testing strategy (usual care).~     Study hypothesis: initial anatomic testing strategy will provide information that will result~     in superior long-term health outcomes as compared to an initial functional testing strategy.~   "
182615|NCT01174537|"~     Patients with specific metastatic cancers who failed prior therapeutic regimes will be~     treated with NDV for at least a year or until disease progression. The study will measure~     progression-free disease and posits that it will be extended.~   "
182616|NCT01174524|"~     The purpose of this study is to determine whether low-dose contraceptive pills are effective~     in the improvement of quality of life in patients in the different phases of menacme.~   "
182617|NCT01174511|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 20% of all babies~     and children around the world. Diagnosis of atopic dermatitis is clinical and depends on the~     existence of at least two out of the four following criteria: itching, a chronic disease~     course with exacerbations and remission ,rash with characteristic distribution and shape ,~     atopia of the patient or family by history.~      Initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and~     allergens. The research product A-1 COOL is a skin cream approved by the Israeli Ministry of~     Health for cooling down of skin irritation. A-1 COOL is rich in herbal medicine ingredients~     and does not contain steroids.A-1 COOL can be beneficial in Atopic Dermatitis patients due to~     its following action mechanisms: sealing of the inflamed skin and retention of water,~     prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the~     herbal ingredients.~   "
182618|NCT01174498|"~     The increased incidence of pain syndromes requires the investigation of pathophysiological~     coherences as well as searching for new therapies. In the recent years neurostimulating~     techniques have been a promising approach regarding their analgesic effect. Combined with~     therapeutic standard procedures they can increase these effects and can have a positive~     impact on co-morbid diseases. The stimulation of the vagus nerve was proved as an efficient~     analgesic method in animal experiments and open clinical pilot studies amongst humans.~     Despite the lack of controlled approaches applying the method against defined pain syndromes,~     the stimulation of the vagus nerve has shown up as an effective method treating other~     psychiatric diseases like depression. The processing of stress, which is involved directly~     and indirectly in the pathogenesis of pain, seems to be susceptible for vagal stimulation.~     Compared with invasive methods the transcutaneous stimulation offers obvious advantages~     concerning appliance and occurrence of side effects. There are no studies so far dealing with~     the neuromodulatory effect on the handling of pain or the clinical therapy of defined~     (chronic) pain related diseases using the t-VNS system. The study hypothesis implies a change~     of experiencing pain when applying the t-VNS in healthy subjects.~   "
182619|NCT01174485|"~     Liposuction is the most popular aesthetic surgery in Brasil and worldwide. Evidence showing~     that adipose tissue is a metabolically active tissue led to the suggestion that liposuction~     could be a viable method for the improvement of metabolic profile through the immediate loss~     of adipose tissue. Studies about the effects of liposuction on metabolic profile are~     conflicting. A few studies report the improvement of insulin sensitivity, inflammatory~     markers and lipid profile, others observe no changes and a few report the worsening of~     metabolic profile. In addition, animal studies show a compensatory growth of intact adipose~     tissue in response to lipectomy. Physical exercise improves insulin sensitivity, lipid~     profile, inflammatory balance, adipose tissue distribution and increases or preserves free~     fat mass. Therefore, liposuction and physical exercise seem to act on similar tissues of the~     body. To the investigators knowledge, there are no studies about the associated effects of~     liposuction and exercise in humans. However, one can suggest that exercise training~     associated with liposuction could: [1] attenuate or block the possible fat recovery or~     compensatory growth; [2] block or reverse the possible harmful effects of liposuction; or [3]~     exert an additive or synergistic effect to the possible beneficial effects induced by~     liposuction on metabolic and hormonal profile and inflammatory balance.~   "
182620|NCT01174472|"~     The aim of the study is to compare the feasibility and the effectiveness, by means of~     immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon~     angioplasty for the treatment of failing dialysis access.~   "
182621|NCT01174459|"~     The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol~     Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine~     medical practice.~   "
182626|NCT01174394|"~     This is a randomized, assessor-blind, placebo controlled study in post stroke depression~     patients. Subjects receiving antidepressant drug would be assigned to either active or~     placebo scalp electro-acupuncture treatment, on the hypothesis that acupuncture intervention~     combined with antidepressants could produce greater therapeutic effects than antidepressants~     alone.~   "
182627|NCT01174381|"~     This study attempts to implement a lifestyle intervention programme aimed at changing the~     dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old~     adults in the MOH area, Ragama and measure the effectiveness of the programme.~   "
182628|NCT01174368|"~     This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of~     subjects with castration-resistant prostate cancer resistant to Taxanes (docetaxel,~     cabazitaxel) and evidence of disease progression on androgen-axis inhibition and/or~     immunotherapy in the form of sipuleucel-T.~      The treatment is being evaluated for its effect on tumor growth. It consists of the placement~     (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA~     macrobeads). The cells in the macrobeads produce substances that have been shown to slow or~     stop the growth of tumors in experimental animals and veterinary patients. It has been tested~     in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II~     studies in patients with colorectal, pancreatic or prostate cancers are in progress.~   "
182629|NCT01174355|"~     A multicenter, open label, escalating dose study to assess the tolerability and the safety~     and to explore the efficacy and the pharmacokinetics of ND0801 in adult patients with~     attention deficit/hyperactivity disorder (ADHD).~   "
182630|NCT01174342|"~     The purpose of this study is to evaluate the effect of child delivery on the intraocular~     pressure in healthy women.~   "
182631|NCT01174329|"~     The objective of the study is to evaluate with clinical parameters the performance of~     Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary~     glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with~     symptoms of xerostomia.~   "
182632|NCT01174316|"~     The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive~     ventilation (NIV) versus standard NIV in patients admitted to hospital with acute~     exacerbation of chronic respiratory failure.~      The investigators hypothesise that autotitrating NIV will ventilate patients with acute~     exacerbations of chronic respiratory failure as effectively as standard NIV.~   "
182633|NCT01174303|"~     This trial is conducted in Europe. The aim of this trial is to investigate the exposure of~     NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1~     diabetes mellitus.~   "
182634|NCT01174290|"~     About one-third of the patients who develop mild, acute confusion (i.e., subsyndromal~     delirium) will go on to develop a severe acute confusional state (i.e. delirium). Delirium~     refers to a temporary change in the way a person thinks about things. Delirium occurs in~     patients admitted to the hospital particularly those patients that are very sick, who are~     given a number of medications, and who are not able to sleep normally. It affects their~     behavior, their understanding of the people and things around them, and their ability to make~     decisions. While ICU doctors do everything possible to eliminate the factors that may cause~     delirium, delirium may cause a person to become very agitated which if not controlled is~     dangerous to their safety as well as the safety of those around them. As well, if delirium~     develops in patients in the ICU, it may increase the risk for death, keep patients in both~     the ICU and hospital for longer and send patients to a long term care facility rather than~     home after they are discharged from the hospital. A recent medical report found that patients~     in the ICU who develop subsyndromal delirium have a mortality rate, a length of stay in both~     the ICU and the hospital, and a transfer rate to a long term care facility that is nearly as~     great as patients with delirium and greater than patients who develop neither subsyndromal~     delirium or delirium. Recent studies in non-ICU patients suggest that if a patient who is at~     high risk for developing delirium receives a medication called an antipsychotic (e.g.~     haloperidol) they may not be as likely to develop delirium or if they do develop delirium it~     will not last as long. No studies have evaluated the effect of administering an antipsychotic~     in patients in the ICU who have subsyndromal delirium. Another study completed in the ICUs at~     Tufts Medical Center found that there may be an association between the development of~     delirium in patients with subsyndromal delirium and the use of haloperidol. However, this~     small study had many limitations and thus it is not currently known whether using haloperidol~     in patients with subsyndromal delirium will actually cause fewer of these patients to develop~     delirium. Haloperidol makes a person sleepy and helps control behavior like agitation.~     Haloperidol is the drug that is used most often to help control delirium in the ICU. This~     prospective, double-blind, randomized controlled study will determine if haloperidol~     administered through the vein four times daily (1mg IV q6h) to patients who have subsyndromal~     delirium, and who are on a breathing machine and being cared for by the Medical ICU service~     at Tufts Medical Center, will help prevent patients from developing delirium. A total of 68~     participants will be enrolled. Exclusion criteria are extensive and include conditions that~     could affect the ability to determine if delirium is present or increase the risk for side~     effects related to the administration of haloperidol. Patients older than 80 will be excluded~     from the study. Study medication (i.e. haloperidol) will be administered until one the~     following occurs: 1) delirium develops (that is confirmed by a staff psychiatrist or his~     designate, 2) the patient is discharged from the ICU at Tufts Medical Center, 3) the patient~     has received haloperidol or placebo for 10 days or 4) an adverse event potentially~     attributable to the study drug is experienced by a patient that is deemed, in the opinion of~     a pulmonologist member of the investigative team to warrant discontinuation of therapy.~     Haloperidol may cause unwanted side effects such as low blood pressure, twitching, and an~     unsafe abnormal heart rhythm. Patients with chronic confusion (e.g., a dementia such as~     Alzheimer's Disease) should not receive haloperidol and will not be included in this study.~     Patients will be carefully monitored for side effects that are potentially related to~     haloperidol. Patients who become confusion-free in the ICU before they leave the ICU (i.e.,~     have no subsyndromal delirium) will be asked to provide consent for all research activities~     that occured in the ICU. If patients where cognition is regained (ie. no subsyndromal~     delirium or delirium) are not willing to provide consent then any study data collected from~     them while they were in the ICU will be destroyed and they will not be approached to~     participate in the post-ICU component of the study. This study also seeks to understand how~     the use of haloperidol in the ICU in patients with subsyndromal delirium may have affect~     memory, emotional status, happiness, ability to function, and quality of sleep in patients~     after they leave the ICU. Patients (that do not have delirium based on CAM screening at the~     time the 3-10 day and 6 month assessments are attempted) will be approached to participate in~     this post-ICU component of the study.~   "
182635|NCT01174277|"~     By doing this study, researchers hope to understand the many changes that occur in the blood~     of people who have chronic GvHD. This may also help the researcher understand how ECP works~     and help guide therapy for patients who have chronic GvHD in the future.~   "
182636|NCT01174264|"~     This randomized clinical trial studies the effect of food on the pharmacokinetics of~     vismodegib. Studying the effects of meals on the absorption of vismodegib may help doctors~     prescribe correct doses and label the drug accurately.~   "
182637|NCT01174251|"~     Polymorphic ventricular tachycardia, known as Torsades de Pointes (TdP), is a specific form~     of ventricular arrhythmia with a characteristic twist of the QRS complex around the~     isoelectric baseline. TdP can degenerate into ventricular defibrillation followed by sudden~     cardiac death. A predictor for the development of TdP is the length of the QT interval~     measured on an EKG recording. The QT interval is known to be prolonged by many medications~     used in a perioperative setting as well as by other conditions such as hypothermia and~     electrolyte imbalance. General anesthesia exposes most of the investigators patients to a~     combination of several of those medications and conditions and therefore might increase the~     risk for the development of QT prolongation. Moreover, patient related risk factors are well~     known and aggravate the individual risk for potential life threatening TdP events when~     exposed to QT prolonging medications perioperatively.~      Previous research suggests that more than 20% of the patients might develop QT prolongations~     perioperatively and are consequently on an increased risk for TdP; yet, no study has~     systematically investigated the magnitude of the problem and associated risk factors.~      The proposed pilot study is designed as a prospective observational cohort study to~     investigate the QT interval before, during and after general anesthesia. It aims to determine~     the incidence of perioperative QT prolongations. A customary long term EKG recording device~     will be connected to a random sample of patients undergoing general anesthesia. Using these~     continuous EKG tracings, the lengths of the QT interval will be analyzed during the~     perioperative period.~   "
182638|NCT01174238|"~     This is a two arm prospective Phase II pilot trial designed to determine the optimal duration~     of break between axitinib and chemotherapy with carboplatin/paclitaxel in melanoma. In this~     study, 6 patients will be enrolled to Arm A, the FLT PET scan (3'deoxy-3'-18F-Fluorothymidine~     positron emission tomography scans)cohort. 30 patients will be enrolled to Arm B, the~     treatment-only cohort. 36 total patients will be enrolled. The treatment schedule will be the~     same in either cohort, with the exception of the FLT PET scans.~   "
182639|NCT01174225|"~     The goal of this study is to provide better information about contraception to women having~     an abortion so that they are less likely to have another unintended unwanted pregnancy.~      Participating subjects will receive their choice of contraception following their abortion~     and if this choice is an IUD they will be randomly assigned to one of two types of copper~     intrauterine devices.~      All participating women will fill out a survey about their contraceptive choices at the time~     of their abortion as well as at 3, 6, and 12 months afterwards. The investigators will also~     follow pregnancy rates at 1 through 5 years after the abortion to see which form of~     contraception was most effective.~      The investigators expect to find that IUDs are the most effective form of contraception but~     that the types of copper IUDs currently available in Canada are not known to be as effective~     as those available in other countries, for which high quality evidence is available. The~     investigators hope to use this data to determine the effectiveness of copper IUDs available~     in Canada.~   "
182640|NCT01174212|"~     Subjects will be consented and then determined randomly whether they will receive antibiotics~     prior to their surgery or during their surgery. Each patient will have cultures taken before~     and during their surgery from the infected hip or knee. Results will be compared after~     completion of the study.~   "
182641|NCT01174199|"~     RATIONALE: Temsirolimus and vorinostat may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Giving temsirolimus together with vorinostat may kill~     more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of~     temsirolimus and vorinostat in treating patients with metastatic prostate cancer.~   "
182642|NCT01174186|"~     Studies with intestinally asymptomatic patients with spondyloarthritis showed that~     approximately 1/3 had visible ulcers in the colon by scopic examinations and 2/3 had changes~     detectable by microscopy. Only those patients who improved in arthritis symptoms showed~     improvement in colonic changes. In these studies only colon and the terminal ileum was~     examined. Inflammation of the small intestine was not examined. Newer studies have shown an~     immunological link between Crohns disease and spondyloarthritis but not ulcerative colitis.~     The investigators wish to examine the small intestine in these patients before and after~     treatment, since they expect to find ulcers there linking spondyloarthritis to Crohns disease~     and healing after treatment.~   "
182643|NCT01174173|"~     The purpose of the study is to determine if the medication, ranolazine (study drug), can help~     improve blood flow to your heart, increase your exercise capacity and improve your quality of~     life (QOL). For this study, you will be asked to perform several tests in order to determine~     if your heart function, exercise capacity, chest pain and QOL have improved after 3 months of~     treatment with ranolazine. Ranolazine is approved by the U.S. Food and Drug Administration~     (FDA) for the treatment of angina.~   "
182644|NCT01174160|"~     This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in~     a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to~     sinus rhythm compared to placebo.~   "
182645|NCT01174147|"~     This study will evaluate the incidence rate of Candida blood stream infection (candidemia)~     among people hospitalized in participating medical centers in Brazil, and will assess the~     antifungal drug susceptibility patterns of Candida clinical isolates. No hypotheses will be~     tested in the study. Candida blood stream isolates collected from people hospitalized for any~     reason during the study period will be sent to a core mycology laboratory for antifungal drug~     susceptibility testing. All people who develop candidemia while hospitalized will be~     considered participants in the study.~   "
182646|NCT01174134|"~     The clinical trial will provide a milk-based drink with constant amounts of nutrients but~     differing amount of Docosahexaenoic Acid (DHA).~   "
182647|NCT01174121|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy that involves taking white blood~     cells from patients' tumors, growing them in the laboratory in large numbers, and then giving~     the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL~     and we have given this type of treatment to over 200 patients with melanoma. Researchers want~     to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or~     ovarian/endometrial cancers. In this study, we are selecting a specific subset of white blood~     cells from the tumor that we think are the most effective in fighting tumors and will use~     only these cells in making the tumor fighting cells.~      Objective:~      The purpose of this study is to see if these specifically selected tumor fighting cells can~     cause digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to see~     if this treatment is safe.~      Eligibility:~      - Adults age 18-70 with metastatic digestive tract, urothelial, breast, or~     ovarian/endometrial cancer who have a tumor that can be safely removed.~      Design:~      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo~     a history and physical examination, scans, x-rays, lab tests, and other tests as needed.~      Surgery: If the patients meet all of the requirements for the study they will undergo surgery~     to remove a tumor that can be used to grow the TIL product.~      Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells.~     {Leukapheresis is a common procedure, which removes only the white blood cells from the~     patient.}~      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the~     conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for~     about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.~   "
182648|NCT01174108|"~     Background:~        -  Stem cell transplants from related donors (allogenic stem cell transplants) can be used~          to treat individuals with certain kinds of severe blood diseases or cancers, such as~          severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow~          to replace that of the recipient. Because stem cell transplants can have serious~          complications, researchers are interested in developing new approaches to stem cell~          transplants that will reduce the likelihood of these complications.~        -  By reducing the number of white blood cells included in the blood taken during the stem~          cell collection process, and replacing them with a smaller amount of white blood cells~          collected prior to stem cell donation, the stem cell transplant may be less likely to~          cause severe complications for the recipient. Researchers are investigating whether~          altering the stem cell transplant donation procedure in this manner will improve the~          likelihood of a successful stem cell transplant with fewer complications.~      Objectives:~      - To evaluate a new method of stem cell transplantation that may reduce the possibly of~     severe side effects or transplant rejection in the recipient.~      Eligibility:~        -  Recipient: Individuals between 4 and 80 years of age who have been diagnosed with a~          blood disease that can be treated with allogenic stem cell transplants, and who have a~          related donor to provide the stem cells.~        -  Donor: Individuals between 4 and 80 years of age who are related to the recipient and~          are eligible to donate blood.~      Design:~        -  All participants will be screened with a physical examination and medical history.~        -  DONORS:~        -  Donors will undergo an initial apheresis procedure to donate white blood cells.~        -  After the initial donation, donors will receive injections of filgrastim to release bone~          marrow cells into the blood.~        -  After 5 days of filgrastim injections, donors will have apheresis again to donate stem~          cells that are present in the blood.~        -  RECIPIENTS:~        -  Recipients will provide an initial donation of white blood cells to be used for research~          purposes only.~        -  From 7 days before the stem cell transplant, participants will be admitted to the~          inpatient unit of the National Institutes of Health Clinical Center and will receive~          regular doses of cyclophosphamide, fludarabine, and anti-thymocyte globulin to suppress~          their immune system and prepare for the transplant.~        -  After the initial chemotherapy, participants will receive the donated white blood cells~          and stem cells as a single infusion.~        -  After the stem cell and white blood cell transplant, participants will have regular~          doses of cyclosporine and methotrexate to prevent rejection of the donor cells.~          Participants will have three doses of methotrexate within the week after the transplant,~          but will continue to take cyclosporine for up to 4 months after the transplant.~        -  Participants will remain in inpatient care for up to 1 month after the transplant, and~          will be followed with regular visits for up to 3 years with periodic visits thereafter~          to evaluate the success of the transplant and any side effects.~   "
182649|NCT01174095|"~     The primary aim of the study is to assess and follow-up subjects that received~     AdGVVEGF121cDNA in IRB protocol #0794-894 entitled Phase I Study of Direct Administration of~     a Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to the~     Ischemic Myocardium of Individuals with Diffuse Coronary Artery Disease and IRB protocol~     #0297-693 entitled Phase I Study of Direct Administration of a Replication Deficient~     Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to the Ischemic Myocardium of~     Individuals with Diffuse Coronary Artery Disease Via Minimally Invasive Surgery.~   "
182650|NCT01174082|"~     The goal of this clinical research study is to learn if vaccinating a donor with your~     purified myeloma protein and then injecting it back into you will help your immune system~     control the multiple myeloma.~   "
182651|NCT01174069|"~     Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be~     feasible and have comparable complication rates as standard lap cholecystectomy. Patient~     benefits will include less pain and scaring.~   "
182704|NCT01173380|"~     The investigators hope to learn about the effects of soy nuts on markers of health. When some~     people eat soy foods, their gut bacteria make equol. Equol is a soy metabolite (small~     molecule made during metabolism). The investigators will be testing blood samples to~     determine if markers of health are different for people who make equol versus people who do~     not make equol.~   "
182652|NCT01174056|"~     The purpose of this research study is to gain understanding of the basic responses of the~     lung to inflammation and specifically if a certain medication can reduce the inflammation~     alone or in combination with another. Inflammation is the way our bodies react to irritation~     or injury, and involves red, warm, and often painful swelling of the affected tissue. Acute~     lung injury involves inflammation that is not specific to one area of the lung and is caused~     by any one of several conditions: infection, trauma, breathing toxic substances, etc. When~     lung injury is severe, not enough oxygen can get into the body; this can lead to the need for~     mechanical support of breathing (mechanical ventilation), problems with brain, heart or other~     organ function, and in some cases, death.~   "
182653|NCT01174043|"~     This research study is looking for patients with newly diagnosed acute myeloid leukemia~     (AML), AML that has returned (relapsed), or it has not responded adequately to previous~     treatments. Treating certain patients with chemotherapy may not be to their benefit or may~     cause more harm than benefit. The purpose of this study is to find out what effects (good and~     bad) erlotinib has on patients and their AML.~   "
182654|NCT01174030|"~     The purpose of this vehicle controlled study is to evaluate the efficacy and safety of~     CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18%~     applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate~     to severe facial erythema associated with rosacea.~   "
182655|NCT01174017|"~     This study compares the ability of a new design of brachytherapy seed for prostate seed~     implants for treatment of prostate cancer to maintain their intended position in the prostate~     after being deposited. Standard seeds, especially in apical locations, have a tendency to~     migrate distally in response to muscular forces. AnchorSeeds have a textured coating which is~     designed to prevent migration. 40 patients who are eligible and suitable for prostate~     brachytherapy will be randomly assigned to receive either standard seeds or AnchorSeeds.~   "
182656|NCT01174004|"~     The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin~     compared to placebo in patients with Parkinson's disease psychosis (PDP).~   "
182657|NCT01173991|"~     The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1~     diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may~     improve glycemic control, glycemic variability and quality of life.~   "
182658|NCT01173978|"~     The incretin effect in patients with type two diabetes is reduced. The investigators have~     previously shown that it is possible to induce a defect in the incretin effect in healthy~     individuals. The purpose of this study is to evaluate the insulinotropic affect of the~     incretin hormones in healthy individuals before and after a deterioration of the glucose~     homeostasis.~   "
182659|NCT01173965|"~     Endometrial ablation in women with dysfunctional uterine bleeding using second generation~     ablation devices is a common widespread therapeutic approach. This study aims to prove that~     amenorrhoea rates using Novasure are higher than those observed in microwave endometrial~     ablation, one year following intervention.~   "
182660|NCT01173952|"~     This study is prospective evaluation of quality of life in men undergoing robotic assisted~     laparoscopic radical prostatectomy versus radical retropubic prostatectomy.~   "
182661|NCT01173939|"~     The study is being conducted to compare the effect of standard treatment (target LDL-C level:~     <120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: <70 mg/dL)~     in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients~     with concomitant type 2 diabetes and hypertension.~   "
182662|NCT01173926|"~     This trial is conducted in Europe. The aim of this trial is to compare the blood~     glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250~     (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.~   "
182663|NCT01173913|"~     Oral administration has many advantages above intravenously administrated drugs for patients.~     Up to now, oral administration of docetaxel as single agent has not been feasible due to low~     and variable bioavailability. This low systematic exposure to docetaxel can effectively be~     increased after co-administration of ritonavir. The department of pharmacy of the Slotervaart~     Hospital and Netherlands Cancer Institute developed a solid oral dosage form for docetaxel,~     ModraDoc001 10 mg capsules.~      Two other novel dosage forms of docetaxel with improved pharmaceutical characteristics, have~     been developed: ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets. The systemic~     exposure after administration of those forms is now being investigated.~   "
182664|NCT01173900|"~     The aims of this study are:~        1. To determine feasibility of a school-based human papillomavirus (HPV) vaccination~          programme in Tanzania.~        2. To measure the uptake and acceptability of two different vaccination strategies in rural~          and urban schools.~        3. To examine the characteristics of accepters/refusers of vaccination and to identify~          reasons for acceptance, refusal or non-completion.~        4. To measure the cost of implementing a school-based HPV vaccination programme in~          Tanzania.~   "
182665|NCT01173887|"~     This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 +~     KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated~     primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy to~     mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall response~     assessment for antitumor effect. The secondary variables include response rate (CR/CRu/PR) in~     the best overall response assessment for antitumor effect, complete or response rates by~     lesion site in the best overall response assessment for antitumor effect, progression-free~     survival and overall survival. The safety and pharmacokinetic profiles of KW-0761 will be~     also determined.~   "
182666|NCT01173874|"~     The investigators hypothesize that cognitive remediation will be superior to the active~     control group on the change from baseline to study end point of cognitive remediation phase~     on both co-primary outcome measures (standardized composite MATRICS score and Cognitive~     Assessment Interview).~   "
182667|NCT01173861|"~     Purpose: Examine the effectiveness of cancer center-based physical activity counseling on~     physical activity rates and quality of life in breast cancer survivors.~      Hypothesis: Participants in the intervention group will indicate greater step counts and~     quality of life at the end of the intervention compared to the control group~   "
182669|NCT01173835|"~     The purpose of this study is to design an incentive-based intervention to motivate a~     tobacco-free lifestyle among high school students and to pilot the intervention in the first~     academic year in two schools (CT and NY) and examine feasibility and acceptability.~     Preliminary efficacy of the intervention will be assessed by implementing it in two new~     schools (CT and NY) in the second academic year and determine an effect size estimate for a~     larger trial.~      The study is intended to assess the number of students joining the program and pledging to be~     smoke-free and to examine changes in tobacco use rates and attitudes following intervention~     exposure. We hypothesize that the schools will have lower rates of tobacco use and~     improvement in attitudes, norms and behavioral control over tobacco use after participating~     in the program.~   "
182670|NCT01173822|"~     The study is an randomized controlled trial (RCT) of 198 coronary artery bypass graft (CABG)~     patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass~     circuit reduces transfusion and bleeding.~   "
182671|NCT01173809|"~     This prospective randomized study aims to investigate the effect of continuous versus~     interrupted use of Amiodarone on the procedure outcome in long-standing persistent (LSP)~     atrial fibrillation patients undergoing pulmonary vein antral isolation (PVAI).~   "
182672|NCT01173796|"~     This prospective, randomized study aims to compare the impact of ablation of perimitral~     flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of~     additional triggers, on procedure outcome.~   "
182673|NCT01173783|"~     It is the aim of this register to document the development of therapies by implantation of~     Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.~   "
182674|NCT01173770|"~     This is a First-In-Man study designed to examine the safety, tolerability, pharmacokinetics~     and functional activity of ADC3680B after single and multiple doses in healthy male~     volunteers.~   "
182675|NCT01173757|"~     The purpose of this study is to evaluate the relationship between plasma drug levels and~     receptor binding in brain using PET; and to evaluate safety and tolerability after a single~     administration of PF-04995274 in healthy volunteers.~   "
182676|NCT01173744|"~     The objective of the study is to examine the treatment of unstable Intertrochanteric~     fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).~      This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be~     randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12~     months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and~     Postelhip score.~   "
182677|NCT01173731|"~     The purpose of this study is to generate long-term safety, tolerability and efficacy data for~     AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID~     (Parkinson's disease, L-dopa induced dyskinesias).~   "
182678|NCT01173718|"~     This study is a prospective, non-randomized, multi-center evaluation of the performance of~     the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease~     (ESRD), who are either currently receiving or expected to require hemodialysis through a~     prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month~     cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other~     arteriovenous grafts (AVGs).~      >~      >~      >~      >~      >~      > A total of 138 Subjects will be enrolled. Once the study procedure has been successfully~     completed, cannulation may occur at any time at the Investigator's discretion.~      >~      >~      >~      >~      >~      > Subjects will be selected from up to 20 Investigational Sites.~   "
182679|NCT01173705|"~     In this project, we propose to recruit lean and obese subjects with different ethnic~     background (African Americans and Caucasians) to study the alterations of lipid and~     carbohydrate metabolism and determine whether these disturbances are linked to genetic,~     inflammatory, oxidative stress, and/or nutritional factors. Because systemic inflammation and~     insulin resistance are frequent features of obesity, we postulate that an unbalanced diet~     with high saturated- and low omega 3-fatty acids is linked to obesity-related inflammation~     and insulin resistance. We propose to investigate fatty acid metabolism and determine the~     links between fatty acid composition and oxidative stress in tissues of lean and obese~     subjects. We propose the following aims:~      Specific Aim 1: Evaluate nutrient intake in lean and obese subjects using the standard NHANES~     Food Questionnaire.~      Specific Aim 2: Evaluate the fatty acid composition, including omega-3, in adipose tissue~     depots, blood monocytes and skeletal muscle, and examine the relationship between omega-3~     content and inflammatory and oxidative stress markers.~      Specific Aim 3: Compare the effects of omega-3 and saturated FA supplementation on~     inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes~     and monocyte culture.~   "
182680|NCT01173692|"~     The goal of this clinical research study is to learn if minocycline can reduce the symptoms~     reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of~     head and neck, who receive treatment with radiation therapy.~   "
182681|NCT01173679|"~     Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) are similar diseases~     of the white blood cells and are typically treated the same way. Recent research shows that a~     key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase.~     Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death of~     CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some~     effect on CLL cells. The purpose of this study is to see of the study drug dasatinib, in~     combination with fludarabine and rituximab, is safe and effective to use for people with~     relapsed or refractory CLL/SLL.~   "
182682|NCT01173666|"~     The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study is a~     randomized controlled trial designed to evaluate the effect of renal artery stenting+medical~     therapy versus medical therapy alone on left ventricular mass progression and cardiovascular~     morbidity and mortality in patients affected by coronary artery disease and renal artery~     stenosis.~   "
182705|NCT01173367|"~     The impact of fever and its management in different medical and surgical populations of~     critically ill patients has not been explained to date. The current study aims to assess the~     safety and efficacy of treatment of critically ill patients with a permissive versus~     aggressive fever treatment strategy.~   "
182683|NCT01173653|"~     The emergency department (ED) serves a vital and growing role in the US health care system,~     responsible for both the delivery of emergent medical care and for safety-net care for~     populations without traditional access to health services. Uninsured populations rely~     significantly on the safety-net services of the ED. Between 2000-2005 the number of uninsured~     Americans increased from 39.6 million to 46.1 million, and this growth is expected to~     continue. Many health policy analysts consider the ED to be an effective place to provide~     preventative care. Prophylactic tetanus immunization, for example, has been a successful~     preventive health intervention that has become a standard of care in the ED setting. Brief~     smoking cessation interventions have been introduced in the ED but have not had great success~     based on lack of follow-up and continuity.~      Our study is novel in that it introduces a brief smoking intervention through use of an~     established, federally-funded and federally-sponsored cessation counseling resource, the~     National Smoking Cessation Quit Line, also available at smokefree.gov. This is a joint~     initiative between the Tobacco Control Research Branch of the National Cancer Institute and~     the Centers for Disease Control and Prevention. Since ED patients who smoke often lack the~     ability to use self-help cessation resources, we hypothesize that by introducing this~     population to the counselors on the National Smoking Cessation Quit Line (also called the~     1-800-QUIT-NOW line) during the ED visit via phone, that this new brief intervention would~     have a realizable and significant effect on smoking cessation among the this population.~   "
182684|NCT01173640|"~     Adverse events due to drug-drug and/or herb-drug interactions are of serious concern and a~     major cause of morbidity and mortality. Resveratrol is a polyphenol antioxidant that has been~     identified in over 70 species and is suggested to be the constituent in red wine responsible~     for cardioprotective effects. The potential health benefits of resveratrol supplements are~     highly extolled in the alternative medicine industry and daily doses are up to 5 grams are~     being studied. While there are potential health benefits of high doses of resveratrol, for~     patients taking other drugs metabolized by CYP3A4, such as transplant medications,~     chemotherapies and HMG-CoA reductase inhibitors, there may be a clinically significant~     herb-drug interaction.~      We, the investigators, have shown in vitro that resveratrol is a mechanism-based inhibitor of~     cytochrome P450 3A4 (CYP3A4). Based on our in vitro evidence and literature reports of the~     pharmacokinetics of resveratrol, we hypothesize that resveratrol will be a potent in vivo~     mechanism-based inhibitor of intestinal CYP3A4 enzymes. To date, there are no clinical~     studies that address the potential for a resveratrol-drug interaction. We propose to test~     whether single and multiple doses of resveratrol alter the pharmacokinetics of midazolam, a~     prototypic CYP3A4 probe drug.~   "
182685|NCT01173627|"~     The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test~     fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.)~     under fasting conditions.~   "
182686|NCT01173614|"~     The purpose of this study is to determine the average values of human ocular biometry and to~     correlate these values with visual function.~   "
182687|NCT01173601|"~     The primary purpose of this study is to assess whether at least 1 dose of LY2216684 (12~     milligrams [mg] or 18 mg once daily) is superior to placebo once daily in the adjunctive~     treatment of participants with major depressive disorder (MDD) who were identified as partial~     responders to an adequate course of treatment with a selective serotonin reuptake inhibitor~     (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.~   "
182688|NCT01173588|"~     The aim of this study was to evaluate the effect of the consumption of yogurt added with~     bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as~     herein described is expected to improve gastrointestinal function and maintain the intestinal~     microflora balance of healthy subjects and perhaps of patients with altered bowel functions.~   "
182689|NCT01173575|"~     This project aims to assess the clinical and microbiological efficacy of fosfomycin(FOM) in~     patients with bacterial infection.~      Primary objective:~      • To assess clinical and microbiological efficacy of FOM in patients with bacterial~     infection.~      Secondary objectives:~        -  To determine the rate and severity of unexpected adverse events.~        -  To determine the mean duration of therapy with FOM in patients with bacterial infection.~      Study design:~      Multi-center, non-interventional study~   "
182690|NCT01173562|"~     The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg~     chewable tablet formulation in a pediatric population. Mebendazole is a drug used for the~     treatment of soil-transmitted parasitic helminth (STH) (ie, parasitic worm) infections such~     as pinworm, whipworm, common roundworm, common hookworm, and American hookworm.~   "
182691|NCT01173549|"~     The purpose of this study is to evaluate the effect of canagliflozin on gastrointestinal~     glucose absorption in healthy volunteers.~   "
182692|NCT01173536|"~     This is a Phase I, single-center, three-arm, randomized, double-blind, active- and~     placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in~     healthy female subjects of non-childbearing potential.~   "
182706|NCT01173354|"~     Weight loss commonly occurs in patients with chronic obstructive pulmonary disease (COPD),~     negatively influencing their quality of life, treatment response and survival. Loss of muscle~     protein is generally a central component of weight loss in COPD patients. Attempts to reverse~     muscle loss in COPD by supplying large amounts of protein or calories to these patients have~     been unsuccessful. Gains in muscle mass are difficult to achieve in COPD unless specific~     metabolic abnormalities are targeted. The investigators recently observed that alterations in~     protein metabolism are present in normal weight COPD patients. Elevated levels of protein~     synthesis and breakdown rates were found in this COPD group indicating that alterations are~     already present before muscle wasting occurs. Furthermore, reduced plasma essential amino~     acid (EAA) levels were observed in COPD patients. These reduced EAA plasma levels were~     significantly related with the presence of muscle wasting in COPD. Until now, limited~     research has been done examining protein metabolism and the response to feeding in patients~     with COPD. Previous studies support the concept of essential amino acids (EAA) as an anabolic~     stimulus in the young and elderly and in insulin resistant states. Until yet no information~     is present on the anabolic effects of EAA in elderly COPD patients.~      It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically~     designed to stimulate protein anabolism will target the metabolic alterations of COPD~     patients. In the present study, the acute effects of an EAA nutritional supplement on whole~     body, muscle and liver protein metabolism will be examined in COPD patients and compared to a~     supplement consisting of a balanced mixture of total amino acids. The principal endpoints~     will be the extent of stimulation of whole body protein synthesis as this is the principal~     mechanism by which either amino acid or protein intake causes muscle anabolism, and the~     reduction in endogenous protein breakdown. Both endpoints will be assessed by isotope~     methodology which is thought to be the reference method.~   "
182707|NCT01173341|"~     The objective of this study is to define the clinical significance of the Neuregulin/ErbB~     signaling pathway and novel echocardiographic measures of cardiac function in predicting~     incident risk of chemotherapy cardiotoxicity.~   "
182693|NCT01173523|"~     Small cell lung cancer (SCLC) is a chemotherapy and radiotherapy sensitive tumor, but with~     very high rates of relapse and metastasis, resulting in a very poor outcome. Among~     limited-stage patients, the relapse rate is at least 80% and among extensive-stage patients,~     the relapse rate is 95-98%. The impetus to develop more effective therapies against novel~     targets in SCLC is therefore high.~      Hsp-90 inhibitors are a new class of drugs with important anti-malignant potential in a~     variety of tumor types because of the reliance of multiple oncoproteins on Hsp90 function.~     Although small cell neuroendocrine tumors generally carry many mutated oncoproteins, without~     clearly defined clients for Hsp90 mediating inhibitor effects in these cells, a recent study~     demonstrated that Hsp90 inhibition causes massive apoptosis by activating the intrinsic~     apoptotic pathway in a number of SCLC cell lines. SCLC is a particularly attractive target~     for apoptosis inducing drugs because of high growth rates and evidence of molecular~     alterations affecting apoptotic mechanisms.~      STA-9090 is a novel, small-molecule inhibitor of Hsp90. Unlike earlier generations of Hsp90~     inhibitors, STA-9090 has been shown to be a potent inducer of apoptosis in a variety of cell~     lines and has anti-tumor activity in multiple types of human xenografts. As was seen with~     other Hsp90 inhibitors, STA-9090 also induces apoptosis in a number of SCLC cell lines.~      Based on the anti-tumor potential seen pre-clinically with Hsp90 inhibition, the potent~     effects of STA-9090 seen pre-clinically as compared with other inhibitors in the same class,~     as well as early data suggesting safety and tolerability of this drug in the Phase I setting,~     we propose to study the single-agent activity of STA-9090 in a Phase II trial of patients~     with relapsed or refractory small cell lung cancer.~   "
182694|NCT01173510|"~     Human Immunodeficiency Virus (HIV) infection is permanently established by integrating a~     deoxyribonucleic acid (DNA) copy into the human chromosome, a step also necessary to complete~     the Human Immunodeficiency Virus (HIV)replication cycle. Standard treatment of HIV infection~     suppresses Human Immunodeficiency Virus (HIV)replication and has not been able to eliminate~     Human Immunodeficiency Virus (HIV)from an infected person because of the integrated Human~     Immunodeficiency Virus (HIV). Raltegravir (RAL), the first approved antiretroviral (ARV) in a~     new class called integrase inhibitors, works by preventing integration of Human~     Immunodeficiency Virus (HIV). For participants with Human Immunodeficiency Virus (HIV)who~     have never taken antiretroviral medications, this research study will test whether~     Raltegravir (RAL), a recommended first-line ARV, can eliminate Human Immunodeficiency Virus~     (HIV)from key immune system cells.~   "
182695|NCT01173497|"~     The purpose of the study is to investigate the response rate for triple negative breast~     cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
182696|NCT01173484|"~     The diagnosis of gastroparesis suggests that delayed gastric emptying is the underlying~     cause of symptoms, but this description fails to explain the variable presentation. There are~     fundamental differences in causes, symptoms, and prognosis among patients with idiopathic~     gastroparesis. Understanding these differences is necessary in order to provide effective~     treatment in these patients. We believe our classification for gastroparesis is a useful tool~     in the management of patients with idiopathic gastroparesis to predict clinical severity,~     treatment response, and future prognosis.~   "
182697|NCT01173471|"~     The purpose of this study is to evaluate the efficacy of systemically administered AZD4017,~     compared with placebo, over a 28-day period in patients with raised intra-ocular pressure~     (IOP).~   "
182698|NCT01173458|"~     The purpose of this study is to determine whether or not CTCs can be detected in blood~     samples taken from patients diagnosed with small cell lung cancer. The purpose is to compare~     CTC analysis to tumor samples to look for differences.~   "
182699|NCT01173445|"~     The purpose of this study is to see if researchers can detect circulating tumor cells (CTC)~     and circulating endothelial cells (CEC) in the blood.~   "
182700|NCT01173432|"~     Adipocyte fatty acid binding protein (A-FABP) is a member of the FABP super family, is~     abundant in adipocytes and macrophages. Regulatory functions of A-FABP in lipid and glucose~     metabolism have been described, and it is suggested to play an important role in the~     pathogenesis of metabolic syndrome.We hypothesize that obstructive sleep apnea (OSA) may~     upregulate A-FABP production and thus causally contribute to metabolic dysfunction. Our group~     has recently demonstrated that A-FABP, expressed and secreted from adipocytes, is present in~     the blood stream .The levels of A-FABP correlated with various metabolic variates in the~     metabolic syndrome. Furthermore, we have obtained novel data in men with a range of sleep~     disordered breathing showed that the duration of oxygen desaturation correlated with~     circulating levels of A-FABP, independent of age and waist/body mass index. The current~     proposal aims to pursue this finding and further explore the role of A-FABP in the~     association of OSA and metabolic dysfunction.~   "
182701|NCT01173419|"~     This is a multi center, randomized, comparison study using two already cleared methods of~     treatment of the great saphenous vein (GSV). The hypothesis to be tested is that the use of~     the Venacure EVLT NeverTouch procedure is no worse than the RF ClosureFAST procedure for~     treatment of the GSV. Evaluation of post operative pain and bruising, quality of life~     assessments, adverse event assessments, confirmation of long term GSV closure, use of~     medications are criteria that will be evaluated during the course of this study.~   "
182702|NCT01173406|"~     The purpose of this study is to examine whether an education programme would enhance~     continuous positive airway pressure (CPAP) adherence.~   "
182703|NCT01173393|"~     That paramedic core cooling during CPR using a rapid infusion of ice-cold (4 degrees C)~     large-volume (30mL/kg) normal saline improves outcome at hospital discharge compared with~     standard care in patients with out-of-hospital cardiac arrest.~   "
183286|NCT01165736|"~     The purpose of this study is to calculate the pharmacokinetics (concentration of compound in~     and rate of excretion from the blood) following a very low dose of compound which will not~     have any pharmacological activity and to monitor for the safety and tolerability of each of~     the compounds in the study.~   "
182708|NCT01173328|"~     Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen~     saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although~     PLB is a strategy that potentially reduces expiratory flow limitation, there are only few~     studies addressing its effects on exercise.~      This study aimed to assess the ability of PLB to change the breathing pattern, degree of~     dynamic hyperinflation (DH) and arterial oxygenation in COPD patients during exercise.~     Exercise tolerance was evaluated by endurance time and respiratory mechanics was evaluated by~     forced oscillation technique.~   "
182709|NCT01173315|"~     The combination of vitamin and mineral supplementation may improve:~        -  glycemic control~        -  lipid profile~        -  oxidative stress~        -  blood pressure~        -  nephropathy indices~        -  neuropathy indices~   "
182710|NCT01173302|"~     This study is to investigate the persistence of rabies Chinese manufactured antibody 1-5~     years after the post-exposure prophylaxis with vero cell antirabies vaccine and antibody~     response to a single booster dose. A total of 160 subjects would be enrolled. These subjects~     were all administered ChengDa antirabies vaccine from 2005 to 2009. After informed consent is~     obtained, these subjects would be tested for their antirabies antibody titer and given a~     single booster dose. Seven and 14 days later, the investigators would re-evaluate the~     antibody titer.~   "
182711|NCT01173289|"~     The primary objective of this study is to estimate the 5 year locoregional control rate after~     External Beam Radiotherapy (EBRT) in the patient with locally advanced differentiated thyroid~     cancer. In a prior retrospective trial for this same group of patients, the 5 year~     locoregional control rate was 85% in EBRT group and 70% in no EBRT group. For the total~     number of patients to detect a minimum of 20% improvement in 5 year locoregional control rate~     with 80% of statistical power and the 5% significance level, the table for sample size~     planning given by Makuch and Simon was chosen. Forty-three patients are required for this~     regimen to regard as worthy of further investigation. Considering 15% follow up loss, 50~     eligible patients will be enrolled.~   "
182712|NCT01173276|"~     This study aims to assess the feasibility of a novel standard of care technique for~     intrauterine insemination (IUI) in HIV-discordant couples in the United States. This study~     will involve couples in which the male partner is HIV positive, but the female partner is~     negative. The investigators will institute a protocol similar to those used presently~     throughout Europe with good success. To date, no HIV seroconversions have occurred in over~     4000 inseminations performed in HIV serodiscordant couples. All male subjects will be on~     stable HAART, and have undetectable serum viral loads prior to insemination. Semen samples~     will be subjected to a stringent sperm wash procedure and screened for HIV RNA. Female~     subjects will be followed post-insemination for seroconversion and pregnancy. Infants will be~     followed for seroconversion at birth through 4 months of age.~   "
182713|NCT01173263|"~     Eligible patients will be allocated to receive propofol sedation titrated to 3 different~     Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol~     sedation — as determined by BIS — lowers esophageal pressure in critical care patients.~   "
182714|NCT01173250|"~     Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical~     operation for management of ulcerative colitis and familial adenomatous polyposis. The~     addition of diverting ileostomy may reduce septic complications. In this randomized study the~     investigators compare two groups of patients with stapled ileoanal pouch one of them had~     diverting ileostomy and in the other this step is omitted.~   "
182715|NCT01173237|"~     With the development of the Intubation Surfactant Extubation technic, in which surfactant is~     administered during a brief intubation followed by immediate extubation, surfactant therapy~     can be given during nasal continuous positive airway pressure treatment further reducing need~     for mechanical ventilation. Preterm newborn babies until eight hours of life, with~     respiratory distress syndrome, will be randomized to standard delivery of surfactant via~     endotracheal tube airway inserted after premedication for pain with midazolam and~     remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent~     is to is to compare efficacy and safety of surfactant administration via two different~     airways and ventilatory approaches.~   "
182716|NCT01173224|"~     Influenza (flu) is a common respiratory infection and often causes severe illness. Few drugs~     are currently approved to treat influenza. This research will test the safety of an~     experimental anti-influenza drug called DAS181 that is given through an inhaler. The purpose~     of this study is to evaluate the safety of this new medication and how the body reacts to it.~     Any side effects will be measured by symptoms, physical examination or laboratory studies.~     About 27 healthy men and women age 18-45, who meet screening requirements, will participate.~     Three separate groups will be enrolled, with approximately 9 subjects in each group. Cohort~     1:20 mg DAS181 or placebo for 1 day (total dose of 20 mg). Cohort 2: 20 mg DAS181 or placebo~     for 10 consecutive days (total dose of 200 mg). Cohort 3: 30 mg DAS 181 or placebo for 1 day~     (total dose of 30 mg.) Procedures include blood samples, electrocardiograms (measures heart~     activity) and breathing tests.~   "
182717|NCT01173211|"~     The purpose of this study is to see how much antibody (proteins produced by the immune system~     that help fight infections) the body makes after getting a flu vaccine. Researchers will also~     look at how the body reacts to the flu vaccine and how it affects the babies of pregnant~     women. The study will enroll approximately 240 women ages 18-39 years, including 180 pregnant~     women in their second or third trimester of pregnancy (at least 14 weeks pregnant) and 60~     non-pregnant women. Participants will be randomly (by chance) assigned to 1 of 3 vaccine~     groups. Each participant will receive one shot of a 2010-2011 flu season licensed vaccine.~     The vaccine will be given as an intramuscular injection (shot in the muscle) in the upper~     arm. Study procedures include pregnancy testing, blood draws, and memory aids. Patient~     participation may be up to 8 months. The information from this study will help guide~     researchers in developing flu vaccines for pregnant women.~   "
182718|NCT01173198|"~     To compare post-surgical outcomes in patients who have undergone Wavefront Guided LASIK~     (iLASIK platform) compared with patients who have undergone Wavefront Optimized LASIK~     (Wavelight Allegretto 400 Hz platform).~   "
182783|NCT01172327|"~     The purpose of this study is to examine the effectiveness and safety of a self-directed~     physical activity program relative to a self-directed dietary program in adults with~     arthritis. A process evaluation will also be conducted to examine program reach,~     participation/dose, fidelity, and participant compatibility/satisfaction.~   "
182719|NCT01173172|"~     This is a boron neutron capture (BNCT) therapy for patients with previously irradiated and~     locally recurrent head and neck cancer. The primary end points are treatment toxicities and~     response rate. The secondary endpoints are time to tumor progression, progression-free~     survival, overall survival and change quality of life.~      Head and neck carcinomas that recur locally after conventional irradiation pose a therapeutic~     challenge. Boron neutron capture therapy (BNCT) is based on the nuclear capture reaction that~     occurs when non-radioactive boron is irradiated with neutrons of thermal energy to yield high~     energy alpha particles and recoiling lithium nuclei. The effect of alpha and 7Li is primarily~     limited to boron- containing cells. Preferential uptake of boron into cancerous tissue is~     achieved using boron carriers such as a derivative of phenylalanine, boronophenylalanine~     (BPA). After administration of BPA by an intra-arterial or intravenous infusion, the tumor~     site is irradiated with neutrons, the source of which is currently a nuclear reactor. A few~     uncontrolled clinical trials have evaluated BNCT in the treatment of glioblastoma after brain~     surgery. In these studies, the median survival times have been 13-15 months after BNCT.~     However, efficacy and tolerability of BNCT in the treatment of limited number of head and~     neck cancer patients showed promising results. Though many basic researches about BNCT has~     been done using Tsing Hua Open-pool Reactor (THOR) at National Tsing Hua University, no~     clinical trial utilizing BNCT is performed in our country. This study will be the first BNCT~     trial to treat head and neck cancer in Taiwan.~   "
182720|NCT01173159|"~     The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion~     containing fish oil) instead of the current lipid emulsion, which contains fat derived from~     soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better.~     It may reduce the harmful effects to the liver, may stop any further liver damage and may~     reverse damage already done to the liver because of the prolonged use of nutrition through~     your child's IV.~   "
182721|NCT01173146|"~     Prostate Cancer is the most common cancer in men, affecting about as many men as women~     diagnosed with breast cancer, and killing about as many men per year as breast cancer kills~     women.~      The most common surgical treatment is prostatectomy, the removal of the prostate. During~     prostate surgery, tumor remains at the edge of the surgery, called residual tumor, in 30% of~     all prostatectomies. Such patients have a significantly higher risk of local recurrence of~     the cancer, and higher rates of death. In contrast, even patients with cancer outside of the~     prostate, but still nearby the prostate, do better when the margins are made clean of tumor~     during surgery.~      The investigators propose to reduce the number of patients with residual tumor after surgery.~     The investigators will test in patients a fluorescent molecule that allows cancer to be~     detected during surgery. If this trial works as designed, the investigators will reduce the~     number of patients who have to receive additional treatment, such as high doses of radiation~     to the lower abdomen, because the amount of residual tumor left behind has been minimized.~     This may also lead to higher rates of survival.~      This type of detection of cancer the investigators employ is called Molecular imaging. The~     investigators believe that molecular imaging will be the key to improved diagnosis,~     individualized treatment selection, and treatment monitoring.~      If successful, a large human trial will be conducted after this study with a corporate~     imaging partner.~   "
182722|NCT01173133|"~     The purpose of the study is to understand the relevance of tissue oximetry measures of tissue~     flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early~     method of detecting compromised flaps.~   "
182723|NCT01173120|"~     The purpose of this study is to determine the safety and acceptability of a device used in~     place of traditional syringes for abatacept self-injection.~   "
182724|NCT01173107|"~     A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.~   "
182725|NCT01173094|"~     The purpose of this trial is to find out the appropriate way to treat DM patients with~     critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of~     femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.~   "
182726|NCT01173081|"~     This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive~     use of teriparatide for the healing of Jones fractures.~   "
182727|NCT01173068|"~     The aim of this study is to determine the outcomes when using ertapenem for complicated~     urinary tract infections in the OPAt setting.~      The study hypothesis: Ertapenem is an efficacious and safe therapeutic option for complicated~     urinary tract infections in the OPAt setting.~   "
182728|NCT01173055|"~     Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue.~     Researchers want to find out if a drug called milnacipran can help people with~     fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of~     fibromyalgia. In this study, milnacipran will be given to find out more about how it affects~     pain and thinking in people with fibromyalgia.~   "
182729|NCT01173042|"~     This pilot study will investigate the effects of acute peanut consumption on markers of~     inflammation, triglycerides and glucose. The hypothesis is that a high glucose/SFA meal will~     increase postprandial production of the inflammatory marker, C-reactive protein (CRP), and~     that the addition of peanuts to the control meal will reduce the production of CRP, as well~     as triglycerides and glucose.~   "
182741|NCT01172886|"~     Healthy women and women with breast cancer have been enrolled in our nested case-control~     study between 2008 and 2009 in order to evaluate the association between metabolic syndrome~     and breast cancer, analyzing anthropometric parameters blood pressure, assessing serum HDL-C,~     triglyceride, fasting plasma glucose, insulin, testosterone and uric acid levels and~     administering a questionnaire about physical activity, food intake, tobacco use, alcohol~     abuse, personal and familial history of disease. Our data support the hypothesis that~     metabolic syndrome may be an indicator of breast cancer risk in postmenopausal women. The~     change of the hormonal arrangement in postmenopausal, along with an increase in visceral~     adiposity, probably favour the hormone dependent cell proliferation, which drives~     tumorigenesis. Adjustments in lifestyle with physical activity intensification and healthy~     diet may represent modifiable factors on which sporadic breast cancer primary prevention may~     work on.~   "
182742|NCT01172873|"~     This is a single site, open-label, feasibility study of cognitive behavioral therapy with~     exposure and response prevention (CBT/ERP) adding the augmentation of D-cycloserine (DCS) for~     adolescents ages 12-17 with Obsessive Compulsive Disorder (OCD) who are partial or~     non-responders to first line treatments of CBT or pharmacotherapy.~   "
182730|NCT01173029|"~     Renin-angiotensin-aldosterone system (RAAS) polymorphisms influence 24h arterial pressure~     fluctuation. Resistant systemic arterial hypertension (RSAH) has an increased risk of end~     organ damage and unfavourable prognosis, whereas pseudo-RSAH usually respond favourably to~     drug therapy.~      To prospectively investigate, in subjects with RSAH in a tropical South American city: 1)~     Adverse cardiovascular events defined as fatal and non-fatal stroke or acute myocardial~     infarction (AMI); and 2) the association of RAAS polymorphisms and adverse cardiovascular~     events in this population.~      Study population: 212 hypertensives recruited from primary care assistance (time since first~     diagnosis of hypertension: 16.5±8.1 years) and without appropriate pressure control, between~     2001 and 2006, corresponding to 0.48% of all hypertensives under care (18 new cases/year),~     57±10 years old, 66% females. Under drug treatment schedule: three or more drugs including a~     diuretic. Ninety two randomly selected hypertensives basis had renin-angiotensin-aldosterone~     system genetic profile determined. Genetic assessment was carried out using a polymerase~     chain reaction assay amplification technique. The following single nucleotide polymorphisms~     were analyzed: renin (G1051A), angiotensinogen (M235T), angiotensin converting enzyme-ACE~     (I/D), angiotensin II type 1 receptor (A1166C), aldosterone synthase (C344T) and~     mineralocorticoid receptor (G3514C).~   "
182731|NCT01173016|"~     This is a single center pilot study in which Laronidase will be given weekly for two years in~     patients with Hurler syndrome, also known as mucopolysaccharide IH (MPS I, Hurler syndrome),~     that have previously been treated with an allogeneic transplant.~   "
182732|NCT01173003|"~     This open-label study is being conducted to determine whether national expansion of a 400 mcg~     of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of~     mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.~      The goal of this study is to provide answers to the following four questions:~        1. What is the effectiveness of this regimen of medical abortion with mifepristone followed~          by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?~        2. Are the side effects with sublingual use tolerable for women?~        3. Is sublingual administration of misoprostol acceptable to women?~        4. Are women satisfied with counseling and services received in new centers offering~          medical abortion?~   "
182733|NCT01172990|"~     This is a pilot feasibility study to evaluate if patients with ST depression Acute Coronary~     Syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/-~     stents will fare better that patients who are taken to the ward area and managed with drug~     therapy and stabilised for 24 hours before being taken to the catheter laboratory.~   "
182734|NCT01172977|"~     It is to be investigated if a correlation exist between the development of the HbA1c value~     and the complication rate is following a stroke.~   "
182735|NCT01172964|"~     RATIONALE: Genetically-modified neural stem cells (NSCs) that convert 5-fluorocytosine (5-FC)~     into the chemotherapy agent 5-FU (fluorouracil) at sites of tumor in the brain may be an~     effective treatment for glioma.~      PURPOSE: This clinical trial studies genetically-modified NSCs and 5-FC in patients~     undergoing surgery for recurrent high-grade gliomas.~   "
182736|NCT01172951|"~     The purpose of this study is to investigate the biological response to a metabolic stress,~     given in the form of a high carbohydrate or fat meal in normal weight, overweight and obese~     individuals and to further explore these responses using novel metabolomic, proteomic,~     transcriptomic and genotyping techniques.~   "
182737|NCT01172938|"~     The purpose of this study is to determine whether apremilast is safe and effective in the~     treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms~     of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated~     patients.~   "
182738|NCT01172925|"~     The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for~     patients and upsetting for their family. Although drugs like morphine and oxygen can help~     some patients feel better, they don't help everybody, and they are not used in patients with~     early symptoms. More relief is needed for these patients. The investigators are studying a~     drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways~     to allow easier breathing. Every patient will get the drug but also a placebo, in a random~     (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they~     feel better with the drug.~   "
182739|NCT01172912|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. An autologous stem cell~     transplant may be able to replace blood-forming cells that were destroyed by chemotherapy.~      PURPOSE: This phase II trial is studying the side effects of giving high-dose chemotherapy~     together with stem cell transplant and to see how well it works in treating patients with~     metastatic germ cell tumors that have not responded to first-line therapy.~   "
182740|NCT01172899|"~     Rationale:~      In the Western world overweight and obesity is an increasing problem both in adults and in~     children. In youth, it is associated with early death and a number of co-morbidities~     including metabolic and endocrine changes, increased inflammatory status, cardiovascular~     abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.~      The standard treatment for morbid obesity in children is by combined life style~     interventions. However, the medium and long term effects of dietetic interventions, behaviour~     therapy and medication is relatively poor. In adults bariatric surgery shows good results~     with up to 30% weight reduction in 3 years. The preliminary results in youth are similar, but~     surgery in this age group is relatively uncommon. In the Netherlands surgery in this age~     group is only allowed in clinical trials, until the benefits and risks have been established.~     (National Health Authorities)~      Objective:~      To determine if surgery gives a superior weight and body mass index (BMI) reduction than~     combined life style interventions in adolescents with morbid obesity and to assess its effect~     on obesity associated co-morbidity.~      Study design:~      Prospective randomised interventional study.~      Study population:~      Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI >40 kg/m2 or >35~     kg/m2 with co-morbidity.~      Intervention:~      Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style~     interventions~      Main study parameters/endpoints:~      Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary~     endpoints: Body composition, pubertal development, metabolic and endocrine changes,~     inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain~     development, quality of life, and behaviour changes. The potential complications of surgery~     are monitored.~   "
182754|NCT01172717|"~     The primary hypothesis of this study is that panitumumab, an inhibitor of the epidermal~     growth factor receptor (EGFR), is an effective treatment for carcinoid syndrome in people who~     fail or do not adequately respond to octreotide or other supportive therapies.~   "
182812|NCT01171950|"~     The purpose of the study is to evaluate the safety and effectiveness of the CentriMag~     ventricular assist system to help pediatric patients who have experienced heart failure~     during surgery and cannot be removed from cardiac bypass.~   "
182743|NCT01172860|"~     A new approach to treating solid tumours (both operable and inoperable) has been carried out~     by the Cork Cancer Research Centre (CCRC) at the Mercy University Hospital, Cork, Ireland~     since 2002.~      The approach simply allows a greater concentration of chemotherapy drugs to enter the tumour~     cells rather than healthy cells. The uptake of the chemotherapeutic drug directly by the~     tumour is aided through applying short electric pulses to the tumor mass (referred to as -~     Electrochemotherapy or ECT). The pulses make the tumour more porous which allows the drug~     easier access into the cancer cells, whereas other tissues and organs in the body remain~     relatively poor at absorbing the drug, thereby reducing the potential side effects on healthy~     tissues. This approach to date has been limited to skin based tumours due to the requirement~     for the electrodes to be placed directly in contact with the tumour. Procedures with~     electrochemotherapy have been applied to human patients in other countries of the EU, the US~     and Japan.~      The drug concentration used is significantly reduced due to the more targeted absorption by~     the tumor and this significantly reduces side effects normally associated with chemotherapy.~      A large number of preclinical and clinical Phase I and I/II studies have demonstrated the~     efficiency and safety of ECT. These studies have included patients with melanoma, head and~     neck squamous cell carcinoma, merkel cell carcinomas, basal cell carcinoma and adenocarcinoma~     nodules. Case reports concerning other primary tumours have also been reported.~      The investigators have developed an endoscopic approach (EndoVe system) for delivering the~     electric pulses to internal cancers and are currently seeking to evaluate its efficacy in the~     treatment of inoperable colorectal cancer. The treatment procedure is similar to standard~     endoscopic colorectal examination (colonoscopy) with the added element of an intravenous~     injection of bleomycin followed after eight minutes by the delivery of electric pulses (each~     one less than 1msec in duration). The pulses are endoscopically delivered directly to the~     tumour mass. The entire procedure is minimally invasive and does not require intensive care~     follow up or stitches. If the treatment is successful the tumour will shrink in size in the~     weeks following the procedure.~      The objective of this study is to investigate the efficacy and safety of this approach in~     reducing the size of the tumour.~   "
182744|NCT01172847|"~     This open label, randomized, three-period crossover study will evaluate the effect of~     co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu~     and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine~     or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between~     treatments. Anticipated time on study is up to 11 weeks.~   "
182745|NCT01172834|"~     Strong evidence shows that physical activity (PA) has favorable psychological and health~     related outcomes. However, most employees do not perform enough PA to achieve health and well~     being benefits. Worksite interventions aimed at improving PA often yield modest effect sizes,~     and their theoretical ground is not profound. The Health Action Process Approach (HAPA), is a~     novel comprehensive theoretical model for health behavior change, that hasn't been studied as~     a whole in a worksite intervention study.~      The objectives of the proposed study are:~        1. To develop a coaching-based group intervention that will be both grounded in theory~          (HAPA) as well as applicable.~        2. To evaluate the feasibility of conducting this intervention among employed hospital~          nurses, using a randomized controlled design, interviews and other evaluation~          procedures.~      The proposed study will offer the most comprehensive empirical test to date of the full HAPA~     model.~   "
182746|NCT01172821|"~     The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over~     a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily).~     Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of~     maintenance treatment with inhaled corticosteroid controller medication in patients with~     moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung~     function, effects on asthma exacerbations, effects on quality of life, effects on asthma~     control, effects on health care resource utilisation, and number of adverse events.~   "
182747|NCT01172808|"~     The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over~     a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily).~     Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of~     maintenance treatment with inhaled corticosteroid controller medication in patients with~     moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung~     function, effects on asthma exacerbations, effects on quality of life, effects on asthma~     control, effects on health care resource utilisation, and number of adverse events.~   "
182748|NCT01172795|"~     Diffuse noxious inhibitory control In order to quantify central sensitization in chronic pain~     patients, the Diffuse Noxious Inhibitory Control (DNIC) model has been used frequently. DNIC~     relies on painful conditioning stimulation of one part of the body to inhibit pain in another~     part, to remove the noise and to focus on relevant stimuli.~      Earlier studies provided evidence for malfunctioning of DNIC in Fibromyalgia (FM) patients.~     However, the cause of this impairment is not yet elucidated, and further study is required to~     unravel the pathophysiology of DNIC in FM.~      Hypothalamus-Pituitary-Adrenal (HPA) axis Besides neural mechanisms, also hormonal~     abnormalities could cause altered pain processing. Cortisol is released in answer to pain to~     suppress the pain. Given the evidence for hypofunction of the hypothalamic-pituitary-adrenal~     axis and the lower cortisol release in response to stressors in a proportion of FM patients~     and in chronic whiplash associated disorders (WAD) patients, the relation between pain and~     cortisol in these patients may be an interesting topic to consider.~      Neurocognitive performance Besides chronic pain, people with chronic WAD and FM suffer from~     severe concentration difficulties and decreased neurocognitive capabilities (reduced reaction~     time, short term memory deficits etc. The decreased neurocognitive performance is known to be~     related to pain severity in various chronic pain populations. It is hypothesized that~     malfunctioning of descending inhibitory pathways and subsequent chronic pain experience~     precludes optimal neurocognitive performance.~      Objectives The present investigation addresses the (patho)physiological mechanisms of DNIC in~     chronic pain populations.~        1. Firstly, patients with FM, chronic WAD and healthy controls are compared regarding~          functioning of DNIC, cortisol levels and response and neurocognitive performance~          (case-control).~        2. Secondly, the possible interaction between the functioning of DNIC, cortisol and~          neurocognitive performance is studied in patients with FM, WAD and healthy control~          subjects (cross-sectional).~        3. Thirdly, to examine whether a fatiguing neurocognitive stressor changes DNIC and~          cortisol levels in patients with FM, chronic WAD or healthy sedentary control subjects.~   "
182749|NCT01172782|"~     The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone~     injection for postoperative pain relief after knee arthroscopic surgery.~   "
182750|NCT01172769|"~     The purpose of this study is to determine whether temsirolimus is effective in the treatment~     of relapsed/recurrent squamous cell cancer of the head and neck (HNSCC)~   "
182751|NCT01172756|"~     The aim of this study is to assess whether single oral doses of Riociguat safely improve the~     cardiovascular function in patients with pulmonary hypertension associated with left~     ventricular diastolic dysfunction~   "
182752|NCT01172743|"~     This protocol is designed to gather a small amount of blood for extraction of DNA for the~     study of the genetic basis of diabetes. The study population will include individuals with~     known diabetes, and controls without diabetes. Investigators aim to understand the genetics~     of diabetes, and will use the cells and serum from this blood to perform genotyping and gene~     expression studies of individuals with diabetes and relevant controls.~   "
182753|NCT01172730|"~     The purpose of the study is to evaluate the use of ultrasound scanning of the thoracic spine~     to define the point of insertion and the depth of the epidural space compared to the blind~     technique.~      The study hypothesis is the use of Ultrasound will improve the success rate of epidural~     placement and may also decrease the rate of complications.~   "
182755|NCT01172704|"~     This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults~     (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and~     secondary prevention intervention [Skills building and Motivational Interviewing (SB-MI) to~     Care as Usual (CAU)]. The study setting is a large urban safety net Medical Center and~     outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions +~     booster) was initially developed as the experimental condition in an R34 pilot project which~     demonstrated its feasibility and promise. For the proposed project, the investigators will~     recruit a larger sample which includes men and women with and without HIV, from various~     ethnic and racial groups, sexual orientations and housing arrangements, as well as a range of~     psychiatric disorders and functional capacities. In this way the investigators can more~     rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a~     sub-study after the 6 month follow-up to examine the impact at 12 months of an additional~     booster session for SB-MI participants. The investigators specific aims are:~        1. To examine the effectiveness of a brief, tailored primary and secondary risk reduction~          strategy to CAU for people with serious mental illness. The desired outcomes include:~             -  Decreased frequency of risk behaviors (number of partners, number of encounters)~             -  Increased use of barrier precautions and IV needle cleaning~             -  Positive changes in information and motivation, as well as risk behaviors~             -  Increased HIV Counseling and Testing for those who do not know their HIV status~        2. To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½~          of participants randomized to SB-MI. The primary outcome will be:~             -  Decreased frequency of risk behaviors and increased use of barrier precautions at~               the 12 month follow-up~   "
182756|NCT01172691|"~     This study is being done to determine if patients receiving (iNO) will have increased liver~     function and less damage from IR than patients who do not receive (iNO).~   "
182757|NCT01172665|"~     The focus of this study is to create a database containing information about patients with~     celiac disease. This database will allow us to examine clinical and epidemiologic features of~     the University of Chicago Medical Center patient population. We have the largest population~     of patients with celiac disease in the mid-West and as such this study using information~     gathered from our database can greatly contribute to our current understanding of this~     disease.~   "
182758|NCT01172652|"~     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of~     ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar~     disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current~     at least moderately severe anxiety.~   "
182759|NCT01172639|"~     The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the~     development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study~     introduced the principle of fast remission induction by means of a combination of standard~     Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose~     glucocorticoids in early Rheumatoid Arthritis.~      The purpose of the present study is to compare different combinations of traditional DMARDs~     and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid~     Arthritis.~      Besides the efficacy and effectiveness of these strategies, patient centered outcomes and~     potential implementation problems of such treatment strategies are evaluated.~   "
182760|NCT01172626|"~     The purpose of this study is to investigate the relationship between the side effects of~     valproate sodium in the treatment of epilepsy in Han Chinese and the genetic polymorphisms of~     drug metabolizing enzymes and pharmacokinetics of valproate sodium.~   "
182761|NCT01172613|"~     The purpose of this study is to determine the appropriate concentration of diagnostic reagent~     of house dust mite (Dp) to be used in diagnostic allergy skin prick test among Thai~     population with allergic rhinitis.~   "
182762|NCT01172600|"~     Epidural injection will be completed under fluoroscopy and all patients will receive 1-4 mg~     of Midazolam for relaxation before procedure and, if needed, 50-100 mcg of Fentanyl~     intravenous (IV). Radiopaque contrast (Omnipaque 300), for confirming the epidural position~     of the needle, steroids and local anesthetic agents will be used according to the physician~     performing the block and will not be controlled by the study. Patients will be randomly~     assigned to receive either inhaled Entonox along with the interventional block they are~     scheduled for or oxygen. They will be blinded about the treatment they are receiving. Those~     randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and~     also continue to receive it for a total of 4 hours in the recovery. Those randomized to the~     oxygen group will receive oxygen through a similar mouthpiece for the entire duration of the~     procedure and recovery for 4 hours. Following completion of procedure the patient will be~     transferred to recovery and monitored for 3-5 hours then discharged home with instructions.~     Possible side effects will be monitored and recorded, pain score of patient will be recorded~     before discharge. All the patients will receive standard instructions regarding physical back~     exercises. This will be repeated for every procedure up to maximum of three blocks.~      The patients will be followed during each block and over a period of 1, 3, 6 and 12 months~     and on each follow-up visit will complete computerized set of questionnaires as they did~     before the procedure. The patients charts will be then reviewed for one year after the~     initial procedure to determine if further epidural steroid injections or surgery for the~     presenting problem were required. It is anticipated that the appropriate number of patients~     will be enrolled within six months of study initiation.~   "
182763|NCT01172587|"~     As they move from preadolescence to adolescence and adulthood, children need nurturing and~     supportive environments to realize their potential. Unfortunately, many children reside in~     destructive families that often result in negative short and long-term outcomes. As~     well-chronicled in the scientific and lay press, an all-too-common example involves parental~     substance abuse. Indeed, children living with a parent who abuses substances often have~     significant emotional, behavioral, and social problems. It has long been recognized that~     interventions are needed to address the clinical needs of these youth and to help prevent the~     development of problems that may emerge in early adulthood. To date, the majority of~     treatments have focused on either treating the children individually, or in the context of~     family therapy. Although directly involving these youth in treatment may be ideal, the~     majority of custodial parents who enter treatment for substance abuse are very reluctant to~     allow their children to engage in individual or family therapy. Thus, interventions for~     substance-abusing parents that do not directly involve children, but serve to improve the~     family environment as a whole, may have the greatest potential for reaching the most children~     and thereby positively influencing their overall adjustment and well-being.~      From this vantage, a promising approach is Behavioral Couples Therapy [BCT] for alcoholism~     and drug abuse, a comprehensive psychosocial intervention for substance abuse that focuses~     both on reducing addiction severity, improving couple adjustment, reducing interparental~     conflict and intimate partner violence (IPV), and improving the family environment and~     psychological functioning. In a series of preliminary studies, the PI found that children~     whose substance-abusing fathers and nonsubstance-abusing mothers participated in BCT~     displayed higher psychosocial adjustment at posttreatment and during an extended follow-up~     than youth whose substance-abusing fathers participated in individual-based treatment (IBT)~     or whose parents participated in a couples-based attention control treatment. These findings~     indicate that BCT may extend beyond the couple to their children and may provide an entry~     point into the family system from which to improve the adjustment of these youth.~      The present study is the next important step for this line of research. First, the present~     study is a far more developed examination of the potential effects of BCT on multiple~     dimensions of youth functioning, taken from multiple perspectives. Second, we do not know~     how BCT works. The positive effects of BCT on parents (reduced addition severity, improved~     dyadic adjustment, reduced partner violence, improved parenting, and improved parental~     psychological adjustment) may have positive trickle down effects on youth; however, we have~     not undertaken an empirical examination of these potential mechanisms of action. If we can~     understand how it works, we will be able to use that information to refine BCT to enhance the~     mechanisms that benefit youth. Thus, the present study will examine possible curative~     mechanisms. Third, we have a very limited understanding for whom it works. Thus, we will~     examine whether BCT may operate differently for children of different stages of development.~     If we can understand this moderating effect, we may be able to develop and refine BCT to meet~     the needs of families with children of different ages.~      To address these issues, the present study will examine how BCT is associated with changes in~     the emotional and behavioral adjustment, beliefs, and behaviors, including serious problem~     behaviors, of youth ages 5 to 18 (as rated by mothers, fathers, and the children themselves).~     We will also focus on potential mechanisms of action that are positively influenced by BCT.~   "
182764|NCT01172574|"~     The objective of this study was to explore the effectiveness of Motor Control Exercise on~     pain, postural alignment and spinal curvatures in women with osteoporotic vertebral~     fractures.~   "
182765|NCT01172561|"~     To increase early detection of cervical cancer by increasing the proportion of Appalachian~     women, age 18 and older, who receive Pap smears at appropriate intervals and return for~     follow-up care when necessary.~   "
182766|NCT01172548|"~     GISTs are the most common mesenchymal tumors of the gastrointestinal tract. Approximately 95%~     of GISTs are positive for KIT (CD117)-the receptor for stem cell factor (SCF). GISTs are not~     responsive to conventional cytotoxic chemotherapy and disease often recurs even after~     complete resection with wide margins.~      Imatinib mesylate (trade names: Glivec® and Gleevec®, imatinib, formerly STI571) is a signal~     transduction inhibitor targeting several protein-tyrosine kinases that are believed to play a~     role in the proliferation of tumor cells. In the Phase II study of imatinib [CSTI571B 2222]~     in 147 patients with recurrent or metastatic GIST, the partial response rates were 67% and~     66% in patients treated at 400 mg/d and 600 mg/d, respectively. Skin rash and elevated~     transaminases were the most common reason for drug discontinuation. The most frequently~     reported AEs were mild nausea, vomiting, diarrhea, superficial edema (primarily periorbital~     or lower limb), myalgia and muscle cramps. Grade 3/4 events included fluid retention (pleural~     or pericardial effusions, ascites, and pulmonary edema), skin rash, liver toxicity and~     gastrointestinal (GI) hemorrhage. Myelosuppression (neutropenia and thrombocytopenia) was a~     consistent finding. Also, a tumor lysis-like syndrome occurred in some patients leading to~     gastrointestinal (GI) and/or intratumoral hemorrhage.~      In a Phase 3, American College of Surgeons Oncology Group trial (ACOSOG Z9001) of adjuvant~     imatinib, imatinib significantly improved 1-year recurrence-free survival (RFS) compared with~     placebo.~      In summary, clinical trials have shown that imatinib produces clinical benefit in most~     patients with unresectable or metastatic GIST and extends median survival from 19 to 57~     months. Imatinib is the standard of care for advanced GIST and has received regulatory~     approval for the treatment of unresectable or metastatic GIST. Studies suggest that adjuvant~     imatinib for 1 year prolongs RFS in patients at high risk of recurrent disease and metastases~     following complete surgical resection of the primary GIST.~      Imatinib is an appealing adjuvant therapy for resected GIST because:~        1. Patients with primary GIST have a high chance of tumor recurrence~        2. Conventional adjuvant treatment modalities are ineffective~        3. Imatinib specifically inhibits the Kit receptor which is constitutively activated in~          most GISTs~        4. Imatinib inhibits the growth of Kit positive cells in vitro~        5. Imatinib is highly effective in many patients with advanced GIST in a Phase II trial~        6. Imatinib has been associated with minimal toxicity in patients with advanced GIST and in~          patients with chronic myelogenous leukemia (CML)~        7. Imatinib may have its greatest impact on survival when there is minimal disease.~      Primary~        -  To assess Recurrence Free Survival Rate in patients with resected primary GIST who are~          treated with adjuvant imatinib for a duration of 2 years Secondary~        -  To compare Recurrence Free Survival, Overall Survival, and Time to Recurrence of~          patients with resected primary GIST who are treated with adjuvant imatinib for a~          duration of 2 years with historical data To assess the safety of imatinib given as~          adjuvant therapy for 2 years in patients with resected primary GIST~   "
182767|NCT01172535|"~     Treatment of children and infants with HIV requires modification of medication dosing~     according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line~     treatment option that is increasingly necessary due to infant drug resistance, this dosing is~     often complicated and impractical in busy clinical settings. To address this, the World~     Health Organization (WHO) has released a simplified dosing table based on infant weight~     bands. This study will evaluate the absorption, safety, and tolerance of LPV/r in infants~     when dosed according to the new WHO guidelines.~   "
182768|NCT01172522|"~     This study examines topical treatment of under eye circles and swelling.~   "
182779|NCT01172379|"~     The purpose of this study is to investigate the safety, tolerability and efficacy of E2007 in~     Parkinson's Disease patients who have wearing off motor fluctuations and on period~     dyskenisias.~   "
182780|NCT01172366|"~     The hypotheses for this study is that there is no transfer of testosterone from male (donor)~     subjects to female (recipient) subjects when contact is made 2 hours post application of 2%~     Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.~   "
182781|NCT01172353|"~     The purpose of this study is to determine whether hydration with sodium bicarbonate is~     superior to hydration with saline to prevent contrast-induced nephropathy.~   "
182782|NCT01172340|"~     The purpose is to determine if a culturally tailored diet and exercise intervention of 16~     weekly sessions with 8 weeks of followup phone support is effective in reducing waist~     circumference, weight, and related diet and exercise behaviors among women from underserved~     communities.~   "
182769|NCT01172509|"~     Our overall objective is to apply Transcranial Magnetic Stimulation (TMS) to develop measures~     of human synaptic plasticity and of brain excitatory:inhibitory ratio (E:I ratio), which we~     propose as novel biomarkers and outcome measures that will expedite clinical trials of~     treatments for Autism Spectrum Disorder (ASD). One potential therapeutic agent, R-baclofen~     will be investigated under this protocol.~      TMS is a safe, inexpensive and noninvasive means to focally stimulate the human brain.~     Presently, TMS is in extensive use as a means to measure regional brain excitability, which~     is dependent on local synaptic strength. TMS can be used to temporarily alter synaptic~     strength as well as to acutely measure levels of cortical excitability and short and long~     interval inhibition. Since altered synaptic plasticity and an imbalanced~     inhibitory:excitatory ratio are cited as fundamental abnormalities in ASD, we hypothesize~     that both severity of ASD-related learning deficits and their improvement after therapy will~     correlate with TMS measures of synaptic plasticity and E:I ratio. We propose to embed TMS~     measures of synaptic plasticity and E:I ratio in a 'Proof of Principal' trial of R-baclofen~     and to examine:~      Aim 1: Whether R-baclofen (a potential therapeutic agent for ASD) predictably alters TMS~     measures of synaptic plasticity and E:I ratio as a function of plasma concentration in adult~     volunteers. We will test the following hypotheses:~        1. R-baclofen produces a significant change in TMS measures of LTD and E:I ratio; and~        2. R-baclofen plasma levels and TMS measures of LTD and E:I ratio show a predictable~          exposure-response relationship.~      Exploratory Aim 1: Whether the presence of genetic polymorphisms of the BDNF and GABA-B~     receptor genes has a moderating effect on TMS measures and on R-baclofen effects. We will~     test the following hypotheses:~        1. Presence of the BDNF val66met allele will be associated with decreased long-term~          depression (LTD) of cortical excitability~        2. Polymorphisms of GABA-B receptor genes will be associated with altered magnitude of~          response to R-baclofen as measured by TMS~   "
182770|NCT01172496|"~     This single center, open label, randomized, two-period, two-sequence cross-over study is~     designed to evaluate the relative bioavailability of a treprostinil diethanolamine 1 mg~     tablet in reference to treprostinil diethanolamine 1 mg oral solution (administered as four~     0.25 mg doses every 2 hours for a 1 mg total dose) in twenty-four healthy volunteers. Other~     secondary outcomes of interest include assessment of pharmacokinetic parameters of~     treprostinil diethanolamine 1 mg tablets and a treprostinil diethanolamine 1 mg oral solution~     administered as four doses (0.25 mg every 2 hours for a 1 mg total dose) and evaluation of~     the safety and tolerability of each treatment regimen.~   "
182771|NCT01172483|"~     Summary: (Objectives and methodology of the project) AIM: To evaluate the clinical~     effectiveness of Community physiotherapy intervention on chronic diseases (heart disease,~     chronic obstructive pulmonary disease, back pain, mechanical neck pain, fibromyalgia,~     osteoarthritis lower limbs, neurological and cancer survivors) and a group of healthy~     patients cardiovascular risk factors. DESIGN: Randomized, controlled, prospective study.~     SUBJECTS OF STUDY: Patients with chronic disease go to the Local Sports Torremolinos Center~     INTERVENTION: Establishment of a control group that give you some advice education care~     (brief advice) and a group common experimental multimodal program of 12 weeks therapeutic~     exercise with health education (brief advice). It will follow up complete with ratings pre~     and post intervention to both groups and follow up at 6 and 12 months for long-term effect~     through specific questionnaires for each subgroup chronic disease and pain score (visual~     scale analog), quality of life (EuroQol-5D) and state health general (Short-Form 12, SF-12)~     VARIABLES: The intervention physical therapy Community. Result: Specific questionnaires for~     each subgroup, pain (Visual analogue scale), quality of life (EuroQoL) and general health~     status (SF-12). DATA ANALYSIS: descriptive statistics, measuring central tendency and~     dispersion of the variables study. Inferential statistics will be made between intervention~     of key variables and outcome (Chi square, Student t, ANOVA, Mann-Whitney, Wilcoxon, by type~     and normal variables). Likewise, establish measures of effect size in main outcome variables,~     by reduction relative risk, absolute risk and odds ratio with their respective confidence~     intervals.~   "
182772|NCT01172470|"~     The purpose of this study is to determine 1-year survival of previously irradiated Head and~     Neck cancer (HNC) patients with loco-regional recurrent disease treated with induction~     chemotherapy with pemetrexed and gemcitabine followed concomitant pemetrexed, carboplatin and~     daily radiotherapy.~   "
182773|NCT01172457|"~     The aim of this study is to assess the efficacy and safety of ozone therapy (vs. placebo)~     applied into the epidural space through epiduroscopy in Patients with Failed Back Surgery~     Syndrome. It´s a Prospective, double blind, randomized study. The investigators will study 30~     patients of both sexes between 18 and 70 years with chronic back pain after lumbar spine~     surgery for more than six months. The patients will receive the ozone gas or placebo (oxygen)~     in the lumbar epidural space, using a spinal endoscope inserted through the sacral hiatus by~     local anesthesia or sedation. The patients will be evaluated before the procedure, with 30~     days, with 3, 6 and 12 months after intervention. This will be run by a researcher who will~     have no knowledge of the gas (oxygen or ozone) to be injected into the lumbar epidural space~     with the aid of an epiduroscopic. Will be applied before and after the procedure, pain scales~     (VAS, McGill, Neuropathic Pain 4, Neuropathic Pain Symptom Inventory), quality of life scale~     (WHOQOL), functional scales of pain disability (Roland Morris and Oswestry Disabilities~     Scales). Only one researcher will keep the data confidential until the end of the study.~   "
182774|NCT01172444|"~     An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Establish~     Therapeutic Equivalence of 1000 mg Mesalamine Rectal Suppositories and Canasa® Rectal~     Suppositories (1000 mg Mesalamine, USP) in the Treatment of Mild to Moderate Ulcerative~     Proctitis will be conducted in 533 patient with a estimated duration of 18months.~   "
182775|NCT01172431|"~     The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal~     function, endothelial function, blood pressure variability by comparison with~     hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and~     Hypertension.~   "
182776|NCT01172418|"~     The purpose of the present study is to determine which antibody induction regimen will result~     in a safer and more effective method to use with steroid avoidance in renal transplant~     recipients. Patients receiving either first cadaveric or non-HLA identical living donor~     kidney transplants will be preoperatively randomized into 2 groups.~   "
182777|NCT01172405|"~     Based on established therapeutic effect of ibuprofen in the treatment of headache attacks,~     and the action of caffeine in promoting better results when combined with treatments of first~     choice in the treatment of headache, this study is designed to:~        -  evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients compared~          to ibuprofen alone;~        -  evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen~          alone.~      The hypothesis is that the association is superior to treatment with ibuprofen alone in terms~     of efficacy, while maintaining good tolerability.~   "
182778|NCT01172392|"~     The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon~     alpha 2a in patients with chronic hepatitis B (HBeAg negativation)~   "
182784|NCT01172314|"~     Weight loss commonly occurs in lung cancer patients, negatively influencing their quality of~     life, treatment response and survival. Gains in lean body mass are difficult to achieve in~     cancer unless specific metabolic abnormalities are targeted. It is our hypothesis that a~     nutritional supplement containing a high amount of essential amino acids will target the~     metabolic alterations of cancer patients. Preliminary research performed in our laboratory in~     elderly supports this hypothesis. We hypothesize that intake of an essential amino acid~     nutritional supplement will positively influence protein synthesis rate in advanced non-small~     cell lung cancer (NSCLC) patients. Furthermore, insight in the underlying mechanism of the~     higher anabolic response of the essential amino acid supplement will be examined. This~     information will potentially enable us to formulate a supplement that is more effective than~     normal food intake, and that will reduce the need for muscle protein breakdown.~   "
182785|NCT01172301|"~     Malnutrition, including muscle wasting commonly occurs in children with cystic fibrosis (CF),~     negatively influencing their quality of life and survival. At the time of a diagnosis of CF,~     severe protein deficits can already be present. It is important to get CF children fed~     adequately to prevent that their condition becomes worse or that recovery takes longer. Oral~     supplementation trials showed that gains in lean body mass are difficult to achieve in CF~     unless specific metabolic abnormalities are targeted. However, the specific needs for certain~     food components are not clear yet in children that are ill. Therefore, more information is~     necessary on the need for protein and certain amino acids in children with CF. Previous~     studies support the concept of essential amino acids (EAA) as an anabolic stimulus in the~     young and elderly and in insulin resistant states. Until yet no information is present on the~     anabolic effects of EAA in CF.~      It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically~     designed to stimulate protein anabolism will target the metabolic alterations of pediatric~     subjects with CF. In the present proposal, the acute metabolic effects of this high leucine~     essential amino acids mixture will be examined in pediatric subjects with CF and compared to~     that of a regular balanced total mixture of essential and non-essential amino acids. The~     principal endpoints will be the extent of stimulation of whole body protein synthesis as this~     is the principal mechanism by which either amino acid or protein intake causes muscle~     anabolism, and the reduction in endogenous protein breakdown. Both endpoints will be assessed~     by isotope methodology which is thought to be the reference method.~   "
182786|NCT01172288|"~     Tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple~     motor and vocal tics that last for at least a year in duration. Currently, there exist~     several effective pharmacological treatments for childhood tics including alpha-2 agonist~     medications (guanfacine and clonidine) and neuroleptics (antipsychotic) medications. These~     medications, however, have significant side-effects and are only partially efficacy in~     treating tics.~      N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and glutamate~     modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in~     this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with~     NAC is nausea and this side-effect is seldom seen in the doses used in this trial.~      NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled~     trial in adults with trichotillomania (chronic hair pulling). Hairpulling is hypothesized to~     be closely related to tics because these conditions (1) have similar clinical characteristics~     -- both groups typically experience urges before engaging in pulling or tics, (2)~     neuroimaging studies suggest they involve similar brain circuits -- the basal ganglia, (3)~     the same pharmacological treatments (neuroleptics) may be effective for both conditions and~     (4) they tend to be inherited together in families. In other trials NAC has evidence of some~     efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia~     and cocaine dependence.~      The investigators are conducting this trial to determine if NAC is an effective treatment for~     tics.~   "
182787|NCT01172275|"~     Pediatric Obsessive-Compulsive Disorder (OCD) affects 1-3% of children. The investigators~     currently have effective first-line interventions for pediatric OCD such as Cognitive~     Behavioral Therapy (CBT) and pharmacotherapy with serotonin reuptake inhibitors (SRIs).~     However, roughly half of children with OCD still have clinically significant OCD symptoms~     despite treatment with first-line pharmacological treatments and CBT interventions for OCD.~     Furthermore, all pharmacological treatments for OCD in children have an increased side effect~     burden when compared to adults. Novel treatments for children with OCD are needed.~      N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and a glutamate~     modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in~     this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with~     NAC is nausea and this side-effect is seldom seen in the doses used in this trial.~      NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled~     trial in adults with trichotillomania (chronic hair pulling). Trichotillomania is an~     obsessive-compulsive spectrum disorder that is hypothesized to be closely related to OCD. In~     other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions~     such as bipolar depression, schizophrenia and cocaine dependence.~      The investigators are conducting this trial to determine if NAC is effective in treating OCD.~   "
182788|NCT01172262|"~     Tinnitus is a poorly understood symptom that is often described either as ringing, clicking,~     ocean sounds, or nature sounds. There is no cure for tinnitus. Approximately 50 million~     Americans are affected with a small minority being severely affected. This study targets~     patients with tinnitus who are severely bothered. Through MRI the investigators plan to~     evaluate the cortical networks of the brain in hopes to better understand this complex~     process.~   "
182789|NCT01172249|"~     This is an open, prospective, randomized, controlled, parallel, multicenter, non-inferiority~     study in 250 individuals (125 individuals per group), with 204 evaluable patients with~     clinical and radiological diagnosis of osteoarthritis of the knee.~      Individuals will be randomized to receive during 180 days the test drug(glucosamine sulfate~     500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) or the reference medication~     (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex®).~      Efficacy will be evaluated through the clinical picture, pain visual analog scale, swelling,~     stiffness in the joint, consumption of paracetamol and quality of life.~      The safety assessment will be done by monitoring the incidence of adverse events and their~     relation to the treatment.~   "
182790|NCT01172236|"~     The main objective of the study is to evaluate the antioxidant effect of lactoferrin and its~     ability to reduce free radicals related diseases in the newborn. This evaluation will be done~     through the assessment of neuro-developmental follow-up.~      The secondary objective is to identify a panel of markers for assessing oxidative stress and~     for a correlation with the lactoferrin antioxidant effect.~   "
182791|NCT01172223|"~     Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or~     amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with~        -  Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m^2 i.v. day 1 q3 weeks),~        -  Paclitaxel (175 mg/m^2 i.v. day 1 q3 weeks), and~        -  Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive~          surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable~          toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor~          size <25% after 4 courses measured by ultrasound or MR-mammography), or if the patient~          requested to be released.~   "
182792|NCT01172210|"~     A substantial percentage of individuals with bulimia nervosa (BN) also meet criteria for a~     co-occurring substance use disorder, such as alcohol abuse or dependence; however, research~     examining this sub-group of patients with BN is limited. Understanding characteristics common~     to both eating and alcohol use disorders may enhance understanding of the mechanisms that~     could contribute to the co-occurrence and perpetuation of these disorders. Individuals with~     BN and alcohol use disorders appear to share some behavioral traits, and therefore, the~     primary aim of the current study is to compare patients with BN with and without an alcohol~     use disorder and normal controls on measures assessing an individual's mood and ability to~     perform certain tasks. Participants will be asked to complete computer-administered and~     paper-and-pencil assessments and two laboratory test meals on separate days. By probing the~     underpinnings of BN and alcohol use disorders, the investigators can determine whether these~     disorders have a shared diathesis, which will lay an essential foundation for future research~     to examine biological and genetic correlates of these disorders. Finally, as little is known~     about the treatment of patients with BN and a co-occurring alcohol use disorder, an~     exploratory aim of the current study is evaluate the suitability and efficacy of a 20-session~     cognitive-behavioral treatment (CBT) addressing both bulimic symptoms and alcohol use.~   "
182793|NCT01172197|"~     The anaesthetic management of patients undergoing total knee replacement is still not~     standardised. Epidural analgesia is common, but is associated with bilateral lower limb motor~     block and limited mobilisation. Spinal anaesthesia with intrathecal morphine provides good~     pain relief, but only for 12 to 16 hours, and is often associated with nausea and vomiting.~     Combined single injection femoral / sciatic blocks give good pain relief, but for a variable~     length of time (between 12 and 24 hours).~      In contrast, continuous femoral perineural infusion of local anaesthetic provides very good~     pain relief for several days. Pain relief is maintained by a constant infusion of local~     anaesthetic using an elastomeric ball. The investigators overriding aim is to develop a local~     anaesthetic regimen which offers complete pain relief for at least 48 hours, yet allows full~     mobilisation within 24 hours Given that ropivacaine may offer a more advantageous~     pharmacological profile (less lipid solubility) compared to levobupivacaine, the~     investigators feel it is pertinent to investigate the capacity of ropivacaine to prevent pain~     relief after surgery. Thus, the investigators aim in this study is to compare the median~     effective dose of levobupivacaine with the of ropivacaine for preventive pain relief after~     total knee replacement. Further, calculation of the equipotent median effective dose's of~     each local anaesthetic allied to objective measurement of quadriceps motor block using an~     electromyogram will allow us to determine the sensory - motor split of each local~     anaesthetic.~   "
182794|NCT01172184|"~     A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is~     associated with a poor outcome, regardless of systolic function. Thus, the LA volume provides~     a long-term view of whether the patient has diastolic dysfunction, regardless of the loading~     conditions present at the examination, such as hemoglobin A1c in diabetes mellitus. To date,~     the relation between the LA volume and left ventricular (LV) filling pressure has not been~     confirmed directly by simultaneous echocardiographic catheterization. The present study,~     therefore, assessed the correlation between the LA volume and LV filling pressure in patients~     with severe mitral regurgitation (MR). Because the LA pressure increases to maintain adequate~     LV diastolic filling, increased atrial wall tension tends to dilate the chamber and stretch~     the atrial myocardium. Therefore, the lower the ability of the left atrium to stretch, the~     greater the pressure in the left atrium. The study is designed to assess 1) the relationship~     between LV filling pressure and LA distensibility, and 2) the power of left atrial~     distensibility to predict the prognosis, including operation mortality, the rate of~     post-operation atrial fibrillation, and late heart failure event in patients with severe~     mitral regurgitation.~   "
182795|NCT01172171|"~     In Denmark, 12.000 people a year, is struck by acute myocardial infarction. A third of these~     cannot be saved before treatment is possible.~      Despite quick and effective reperfusion of the coronary arteries using PCI (Percutaneous~     Coronary Intervention) after an acute ST-elevation myocardial infarction, substantial~     morbidity and mortality remain. Infarct size is an important determinant of the short-and~     long-term outcome after acute myocardial infarction. The most widely used and most effective~     proven therapy to limit infarct size is the early reperfusion induced by or PCI.~      Although beneficial in terms of myocardial salvage, reperfusion itself may contribute to~     additional damage of the myocardium; the damage due to the combined processes is known as~     ischemia-reperfusion injury. The pathogenesis of myocardial ischemia-reperfusion injury is~     a multifactorial process involving the interaction of multiple mechanisms. Numerous studies~     indicate that there are three pivotal factors in the pathogenesis of ischemia-reperfusion~     injury: elevated oxidative damage, depressed energy metabolism, and altered calcium~     homeostasis.~      Partially reduced species of oxygen, including the superoxide anion radical, hydroxyl~     radical, and hydrogen peroxide, are generated intracellularly as by-product of oxygen~     metabolism. These reactive oxygen species cause peroxidation af membrane lipids, denaturation~     of proteins, and modification of DNA, all of which ultimately can lead to cell death. In~     mammals, cell damage induced by partially reduced oxygen species can also initiate local~     inflammatory responses, which then lead to further oxidant-mediated tissue injury.~      Melatonin is mainly known for its role as an endogenously produced circadian hormone.~      For the last twenty years, increasing evidence has proven melatonin to be a very potent~     direct and indirect antioxidant.~      Recent experimental studies have documented the beneficial effects of melatonin in reducing~     tissue damage and limiting cardiac pathophysiology in models of experimental~     ischemia-reperfusion.~      Primary hypothesis: Melatonin given to patients undergoing PCI can reduce the myocardial~     damage sustained by ischemia-reperfusion.~   "
183287|NCT01165723|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.~   "
182796|NCT01172158|"~     Ureteral stents has become an indispensable instrument for urology practice as a result of~     widespread use of endourological interventions. Removal of stents could be sometimes~     neglected by patients or physicians. This omission may lead to legal and medical problems for~     urologists, health institutions and also for patients. In this study, the investigators offer~     a computer program providing two sided recall to prevent this nasty complication with sending~     automatic message by short message service (SMS) to both the patient and the urologist.~   "
182797|NCT01172145|"~     This study examined the effects of modafinil on apathetic symptomatology, performance of~     activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's~     disease (AD).~   "
182798|NCT01172132|"~     The purpose of this study is to determine:~        -  Condition of intensive care unit (ICU) admission in patients with haematological~          malignancies.~        -  ICU hospital and up to one year mortality.~        -  Assessment of post ICU burden and health related quality at 90-d and 1 year.~   "
182799|NCT01172119|"~     Prospective, multi center, randomized, single blinded study designed to demonstrate the~     safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery~     System at multiple time points compared to the Taxus Liberte DES in the treatment of single~     de novo native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.0 mm and ≤ 14~     mm in length.~   "
182800|NCT01172106|"~     There is currently no clear involvement of families/caregivers in the care for postpartum~     mothers that develop postpartum psychosis. The lack of knowledge on causes of postpartum~     psychosis may influence the nature of perceived social support that mothers receive from~     caregivers. It is hoped that the provision of a culturally adapted version of family~     psychoeducation will bridge the knowledge gap and provide the much needed information. We~     therefore hypothesized that the involvement of a family member of a postpartum mother with a~     psychotic illness in a weekly session of family psychoeducation.~   "
182801|NCT01172093|"~     OSA is prevalent among patients with type II DM~   "
182802|NCT01172080|"~     Although systems are in place to ensure results of tests are communicated to patients, there~     is currently no generalized accepted strategy to ensure that patients undergo recommended~     follow-up testing. When follow-up tests are recommended months to years into the future,~     there is a high likelihood that the test will either be delayed or not performed resulting in~     the potential for poor outcomes and litigation. For this reason, there is a clear need for~     systems to be developed which automatically trigger patient communication when the date of a~     recommended follow-up test is approaching. The investigators propose to design a protocol for~     ensuring that patients are reminded to schedule follow-up tests and that this communication~     is documented in the online medical record. This work will provide the foundation for the~     creation of systems that significantly improve patient care, and can be easily adapted for~     use in many clinical departments and institutions.~      Aim 1. To use patient focus groups to help design a system for improving adherence to~     endoscopy follow up recommendations~      Aim 2. To develop a prototype endoscopy follow up system and test the effectiveness of the~     system on a cohort of patients due for a surveillance colonoscopy.~   "
182803|NCT01172067|"~     The purpose of this study is to demonstrate that QuickOpt optimization can be as an~     alternative method for CRTP/D patients' optimization in clinical practice through the~     comparison of the improvement differences between the CRTP/D patients with different~     optimization at 12 months after implantation.The hypothesis is that the Heart Remolding~     parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after~     implant is not inferior (10%) to the patients by Echo optimization。~   "
182804|NCT01172054|"~     This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and~     immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a~     single dose vaccination on day 0.~   "
182805|NCT01172041|"~     This study will investigate whether audiovisual biofeedback, in which visual and audio cues~     are used to regulate the patient's breathing, can increase the image quality of 4D CT and 4D~     PET scans.~   "
182806|NCT01172028|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells of by stopping them from dividing.~     Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of giving pemetrexed~     disodium and docetaxel together in treating patients with advanced solid tumors.~   "
182807|NCT01172015|"~     Immunologic thrombcytopenic purpura (ITP) affects both children and adults. The incidence is~     estimated in adults about 1,6/100 000/per year. Chronic and relapsing forms of the disease~     that represent 70% of adult cases are associated with impairment of quality of life related~     to treatments side effects and bleeding. ITP is secondary to the destruction of circulating~     platelets through an auto-immune process and to a decrease of platelet production in bone~     marrow. Auto antibodies are usually directed against epitopes of the GPIIb/IIIa, expressed by~     platelets. The destruction of the platelets seems to occur mainly in the spleen through~     antibody dependent cytotoxicity. Both macrophages and cytotoxic T lymphocytes subsets~     participate to the platelet destruction through the CD16, the low affinity receptor for the~     Fc of IgG. Thus the CD16 pathway is a target for treatments in ITP as for example~     intravenous immunoglobulins and more recently inhibitors of the syk kinase.~   "
182808|NCT01172002|"~     Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis~   "
182809|NCT01171989|"~     The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A~     vaccine when administered as a booster dose following priming in the first year of life with~     the same vaccine.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00970307).~   "
182810|NCT01171976|"~     The purpose of this study is to demonstrate that two investigational treatment regimens have~     the potential to result in a superior visual acuity improvement as compared to a ranibizumab~     pro re nata (PRN=as needed) treatment regimen.~   "
182811|NCT01171963|"~     The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK~     Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.~   "
182813|NCT01171937|"~     The proposed study attempts to deepen our understanding of repetitive behaviors in autism~     spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits~     associated with risperidone treatment using functional MRI. This study is a substudy of a~     larger center grant (IRB#07-03-066). Other studies also under this center grant, include:~     IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another~     sub-study, should they meet criteria. The proposed study will address this aim by mounting a~     controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment,~     children will enter a three-part study. Phase 1 will be an 8-week, double-blind,~     placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week~     open-label maintenance phase for responders to risperidone or placebo. Non-responders to~     placebo will be invited to enroll in the eight-week open-label study. 48 of the participants~     will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The~     medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to~     4.0mg.~   "
182814|NCT01171924|"~     This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and~     neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a~     multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human~     epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is~     designed to compare the safety and tolerability of CUDC-101 when administered at the maximum~     tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.~   "
182815|NCT01171911|"~     Both calcium channel antagonist and beta-blocker have cardioprotective effect. Endothelial~     shear stress is predictive factor of clinical outcomes in patients with obstructive stenosis.~      The present study aims at comparing the re-distribution of shear stress and blood velocity~     during whole cardiac cycle after trans-coronary injection of Nicardipine and esmolol.~   "
182816|NCT01171898|"~     The purpose of this study is to assess the safety and activity of ARN-509 in men with~     advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1~     of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase~     2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of~     ARN-509.~   "
182817|NCT01171885|"~     The objective of this study is to compare the postoperative analgesia afforded by bilateral~     superficial cervical block using different concentrations of local anesthetic (ropivacaine)~     in patients undergoing total thyroidectomy for the mini-incision technique, performed by the~     same surgical team.~   "
182818|NCT01171872|"~     Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC),~     is a idiopathic, chronic and frequently disabling inflammatory disorder of the intestines~     characterized by a dysregulated mucosal immune response that affect more than a million~     Americans. This protocol is aimed at obtaining tissue samples to test for expression of genes~     associated with IBD and to better understand the pathogenesis of IBD with the study of~     genetics, proteomics, physiologic processes and microbiomes (microbiology).~   "
182819|NCT01171859|"~     This study is being conducted to explore the potential benefits of a twelve-month doxycycline~     (at the best tolerated dose of 200 mg/day) and tauroursodeoxycholic acid (750 mg/day)~     treatment on disease progression in patients affected by transthyretin amyloidosis,~     including: 1) patients not eligible for liver transplantation; 2) patients eligible for liver~     transplantation, as a bridge therapy between the time of diagnosis and surgery, with the~     aim of stabilizing the disease; 3) patients showing disease progression after liver~     transplantation performed since at least 1 year.~      It is a phase II, therapeutic exploratory, two-part, 18-month, single centre, prospective~     study.~      Part I is a 12-month, open label treatment period in which doxycycline (200 mg/day,~     continuously) and tauroursodeoxycholic acid (750 mg/day continuously) are administered to 40~     consenting subjects with transthyretin amyloidosis. Part II is a withdrawal period in which~     subjects will be monitored for disease progression. During part I, subjects will be evaluated~     at baseline (study Day 0), and then after 3, 6, 9 and 12 months of doxycycline plus~     tauroursodeoxycholic acid treatment or at premature treatment discontinuation; during part~     II, they will be assessed at months 15 and 18. Monthly phone contacts and blood tests will be~     performed to monitor potential adverse events.~   "
182820|NCT01171846|"~     Pelvic organ prolapse is a problem experienced by women where a bulge comes down in the~     vagina, and may even drop down outside the vagina. The bulge in the vagina is caused by other~     organs moving down from their normal position in the pelvis and pushing into the vagina. This~     is a very common problem and many women who have given birth will have a very mild bulge~     which does not cause them symptoms. Women can however experience a variety of pelvic,~     bladder, bowel and sexual symptoms which impact on daily life. No research studies have~     properly examined whether or not exercises can prevent prolapse. This study aims to explore~     whether exercises taught by a physiotherapist can prevent women developing a prolapse which~     requires them to have treatment.~   "
182821|NCT01171833|"~     Three groups of patients are going to have minor surgery under general anesthesia with~     inhaled anesthetics and different ventilatory setting (Tidal volume: 8, 10, 12 ml/kg,~     respiratory rate: 10/min each). Group A (Sevoflurane) will use sevoflurane, group B~     (Desflurane) will use desflurane, and group C (Isoflurane) will use isoflurane. It will be~     observed differences among the groups for ventilatory effects on speed of induction.~      Duration of this randomised controlled trial will be about 3 months. Estimated sample size~     will be 36 patients(12 in each group).~   "
182822|NCT01171820|"~     The purpose of this Clinical Evaluation is a continuation in the assessment of the~     performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in~     the treatment of patients with de novo coronary artery lesions in patients (Diabetic~     sub-study).~   "
182823|NCT01171807|"~     The purpose of this study is to investigate the efficacy and safety of erythrocyte-mediated~     delivery of dexamethasone in steroid-dependent ulcerative colitis patients~   "
182839|NCT01171599|"~     The purpose of this National Cancer Institute (NCI) funded study is to develop and test the~     acceptability and usability of a web & text message based weight loss intervention for~     childhood acute lymphoblastic leukemia (ALL) survivors. Childhood cancer survivors ages 7 -~     18 will provide feedback during focus groups on a web and text message based program that was~     developed.~   "
182824|NCT01171794|"~     This is a research study on Altitude Illness. From the information collected and studied in~     this project we hope to learn more about Altitude Illness, including factors that may affect~     and prevent the development and progression of this condition. We hope to learn if the~     commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude~     illness. Possible participants in this study are healthy adults who indicated they would like~     to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford~     University researchers hope to enroll about 100 participants.~   "
182825|NCT01171781|"~     The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe~     based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal~     carcinoma~   "
182826|NCT01171768|"~     Vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) are major mediators of~     angiogenesis and are induced by tissue inflammation and hypoxia. While elevated serum VEGF~     levels have been reported in inflammatory lung diseases, especially with hemoptysis, there~     was no study to evaluate the Ang-2 levels in lung inflammatory diseases according to the~     presence of hemoptysis, inflammatory biomarker and hypoxia.~   "
182827|NCT01171755|"~     In current study, we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy~     in advanced BTC.~   "
182828|NCT01171742|"~     Intermittent hepatic inflow occlusion (IHIO), also called Pringle maneuver, is a safe and~     effective procedure for major hepatectomy in patients with liver disease. In addition,~     ischemic preconditioning with IHIO has been reported to have protective effects in patients~     undergoing liver resection. The role of IHIO, however, has not been fully elucidated in~     donors and recipients during living donor liver transplantation.~   "
182829|NCT01171729|"~     This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men~     with hormone-Refractory Metastatic Prostate Cancer.~   "
182830|NCT01171716|"~     the purpose of this study is to identify how the body responds to increased dietary protein~     (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes~     in blood glucose, hormones, appetite, and energy expenditure will be examined.~   "
182831|NCT01171703|"~     The purpose of this trial is to find out the appropriate way to treat DM patients with~     critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of~     femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.~   "
182832|NCT01171690|"~     This study evaluated the effects of teriparatide (Forteo) on low calcium levels in the~     setting of thyroid surgery associated with low parathyroid hormone. The hypothesis was that~     teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in~     patients with symptomatic hypoparathyroidism.~   "
182833|NCT01171677|"~     Addiction to illicit and prescribed drugs, alcohol and tobacco is associated with a panoply~     of brain changes that contribute to structural and micro-structural deficits, altered~     metabolism and neurotransmission, and related cognitive deficits affecting executive~     function, decision-making, reward salience and motivation. Many of these deficits may act as~     barriers to recovery, compromising the same spectrum of cognitive processes that established~     interventions (motivational enhancement, cognitive behavioral therapy, therapeutic~     communities, etc.) depend on for successful outcomes. Even where there are medications that~     target a specific addiction (e.g., methadone for opiates), meaningful, sustained recovery~     relies on the acquisition of adaptive skills and strategies. As such, there is a need to~     develop interventions for substance use disorders that have the potential to improve health~     and cognitive and psychosocial functioning, and to be embraced by the treatment community. A~     growing body of basic and clinical research suggests that physical exercise may reduce drug~     use and improve cognitive-executive function, mood, and motivation. There is also a growing~     literature on the effectiveness of positive affirmation as a cognitive-behavioral~     intervention for depression and PTSD both of which frequently co-occur with addiction.~     Building on this, we hypothesize that a combined exercise and affirmation intervention~     (IntenSati) will lead to improved cognitive and psychosocial function. To test this, we~     propose to conduct a two-arm randomized clinical trial - in adult volunteers with a history~     of longstanding substance use and who are in treatment in a residential therapeutic community~     setting (Odyssey House) - to examine cognitive and psychosocial function before, during, and~     after randomization to either a twelve-week IntenSati intervention condition or to a~     twelve-week no-exercise/no-affirmations control condition. This is a pilot study intended to~     collect data on feasibility and effect size. The population and sample size were selected on~     the basis of likelihood to benefit from the intervention, likelihood for good adherence, and~     the realities of completing a low-cost pilot study within a one-year timeframe. Overall there~     were no substantial differences between IntenSati and TAU on measures of cognition, mood, and~     psychosocial functioning. Limitations include the small sample size, limited exercise~     intensity and capacity, missed exercise classes, dropout because of placement, work schedules~     and non-study-related medical conditions.~   "
182834|NCT01171664|"~     To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom~     scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on~     placebo.~   "
182835|NCT01171651|"~     The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594~     (Pexa-Vec) administered intravenously and intratumorally prior to standard sorafenib therapy.~   "
182836|NCT01171638|"~     This is a prospective observational study to determine the reliability and accuracy of Near~     Infrared Spectroscopy (NIRS) to detect oxygen flow in the extremities of injured and~     non-injured soldiers over time. This technology may be useful in the detection of acute~     compartment syndrome. We hypothesize that:~        -  NIRS values will be well-correlated with intracompartmental pressure measurements~        -  NIRS values will be significantly different between non-injured and injured extremities,~          and injured extremities treated with fasciotomy for acute compartment syndrome.~        -  NIRS values of the upper extremity and feet will correlate to values from normal legs in~          critical control patients and patients with unilateral sever lower extremity injuries.~   "
182837|NCT01171625|"~     The purpose of the study is to demonstrate the long term safety and effectiveness of the~     Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve~     replacement with or without concomitant procedures requiring cardiopulmonary bypass.~   "
182838|NCT01171612|"~     The purpose of this study is to evaluate and monitor perioperative management of patients~     with coronary stents undergoing noncardiac surgery.~      Objectives:~        -  To describe the incidence and severity of adverse cardiovascular events in patients with~          coronary stents undergoing noncardiac surgery with admission.~        -  To assess the following-up of the guidelines about the perioperative management of~          antiplatelet therapy in these patients.~        -  To assess the relationship between the incidence of cardiac or neurovascular events, as~          well as bleeding complications with the perioperative management of antiplatelet~          therapy.~        -  Number of Participants with Adverse Events as a Measure of Safety~   "
182883|NCT01171014|"~     The purpose of this study was to investigate the dose response effect of Bifidobacterium~     lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.~   "
182840|NCT01171586|"~     The purpose of the National Cancer Institute (NCI) funded randomized controlled study is to~     develop and evaluate a text message (SMS) based weight loss intervention to 309 overweight or~     moderately obese English and Spanish speaking adults ages 21 - 60. The investigators propose~     that participants randomized to the intervention arms will lose significantly more weight~     than those participants randomized to the control group.~   "
182841|NCT01171573|"~     Polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM)belong to a group of~     inflammatory muscle disorders, of unknown cause, that are characterised by skeletal muscle~     inflammation and progressive muscular weakness, which can be debilitating and chronic in~     nature (occasionally fatal).~      The current treatment options for these conditions are steroids and various other~     immunosuppressive drugs. However, these are usually only partially effective at reducing~     symptoms, and their toxic side effects also limit their usefulness. In order to develop more~     specific treatments for myositis in the future (and therefore more effective), it is~     important to understand the exact mechanisms that cause the disease in the first instance. In~     other similar inflammatory diseases such as rheumatoid arthritis (RA) and systemic lupus~     (SLE), it is known that changes to the Human Leukocyte Antigen(HLA), as well as certain~     inflammatory cytokines, are involved in both the development and expression of the disease.~      As many of the inflammatory mechanisms that cause damage in PM, DM and IBM are similar to~     those in RA and SLE, it seems likely that similar genetic factors will also be involved in~     the development and expression of PM, DM and IBM.~      In order to understand the genetic aspects / causes of myositis, and ultimately develop more~     effective treatment therapies in the future, patients with PM, DM or IBM, will be asked to~     give 20 mls of blood. These blood samples, along with the patient's clinical details, will~     then be sent to the Centre for Integrated Genomic Medical Research (CIGMR), at The University~     of Manchester, where all of the genetic analyses will take place. By understanding the~     genetic cause of the disease, it should be possible to design specific drugs for treating the~     condition in the future.~   "
182842|NCT01171560|"~     In anesthetized patients the airway needs to be secured due to lack of protective reflexes.~     Golden standard is the endotracheal intubation. In patients undergoing lung surgery single~     lung ventilation is essential. In these cases a double lume tube is commonly used. The double~     lume tube has a proximal tracheal and a distal bronchial end reaching into the left or the~     right side of the lung dependant of the model of the tube. Thus it is possible to operate on~     one collapsed side of the lung while ventilating the other side.~      Due to length and stiffness resulting of the construction of the device more side effects~     than after intubation with a conventional single lumen tube is expected. Possible side~     effects may be bleeding, swelling, sore throat or croakiness.~      The EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a~     device placing a balloon into one bronchus to be able to provide single lung ventilation like~     the double lume tube. However, the EZ-Blocker is a catheter pushed through a conventional~     single lume tube after intubation with a hook on one and a balloon on the other distal end.~     The hook prevents the device from being pushed too far to be able to harm the lung. Inside~     the EZ-Blocker is a small lumen able to deflate the lung which is blocked with the balloon.~     The device is easily positioned using a bronchoscope and when the anaesthesiologists~     confirmed the correct position of the device, the balloon can be inflated and deflated as~     needed.~      Due to the easier approach the investigators expect less side effects as mentioned earlier~     using the EZ-Blocker compared to the double lume tube. As well the stress caused by~     intubation may be reduced.~   "
182843|NCT01171547|"~     The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with~     suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous~     hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation~     for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.~   "
182844|NCT01171534|"~     Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often~     require multiple returns to surgery for closure, and occasionally require skin grafting (i.e.~     they are never completely closed). We are interested in seeing whether this device, which~     provides constant and gradual tension on the wound, may allow for rapid wound closure in a~     safe fashion, perhaps even precluding a return trip to surgery.~      Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc,~     Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than~     standard vessel loop techniques.~      Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of~     return trips to the operating room for surgical procedures related to closure or skin~     grafting of fasciotomy wounds.~   "
182845|NCT01171521|"~     Complex wounds that cannot be closed primarily are at great risk for complications. A new~     technique utilizing external tissue expansion holds promise in rapidly decreasing wound area.~     Facilitation of rapid wound closure is critical in preventing wound complications.~      Hypothesis:~      Using the Dermaclose Wound Management System (Woundcare Technologies, Inc., Chanhassen, MN)~     in complex wounds not able to be primarily closed will decrease the time to secondary closure~     and decrease the need for secondary soft tissue coverage procedures, or if secondary soft~     tissue procedures are required, its use will decrease the size and complexity of the~     secondary soft tissue procedures.~      Null Hypothesis:~      The Dermaclose system will not decrease the need, dimensions, or complexity of secondary soft~     tissue coverage procedures in complex wounds not able to be primarily closed.~   "
182846|NCT01171508|"~     The purpose of this study is to investigate circadian disturbances after breast cancer~     surgery by means of monitoring sleep and heart-rate variability, by measuring a metabolite of~     melatonin in urine and by questionnaires and a sleep-diary.~   "
182847|NCT01171495|"~     Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve,~     asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.~   "
182848|NCT01171482|"~     The aim of this study is to compare the efficacy of sorafenib to 5-fluorouracil/mitomycin in~     HCC patients with pulmonary metastasis whose intrahepatic tumors has been controlled with~     locoregional therapies.~   "
182884|NCT01170988|"~     Is the surgical treatment of patients with coronary heart disease using the T-graft technique~     an adequate solution that provides a sufficient myocardial flow reserve? A magnetic resonance~     examination (MRI) is required.~   "
182885|NCT01170975|"~     This study explores the effects of food (a high-fat meal) on the pharmacokinetics of~     tesetaxel.~   "
182849|NCT01171469|"~     This is a single center Phase I study to determine the safety and maximum tolerated dose~     (MTD) of autologous dendritic cells (DCs) loaded with allogeneic brain tumor stem cells~     administered as a vaccination in children and adults with recurrent brain tumors. Once the~     MTD has been determined, we will conduct a phase II study to determine efficacy.~      Clinical trials that utilize DCs for immunotherapy have demonstrated significant survival~     benefit for patients who exhibit robust immune responses against tumor cells. Unfortunately,~     at the present time the majority of tumor patients are unable to mount an adequate immune~     response and thus succumb to their tumors. We postulate that the inability to generate an~     appropriate immune response in these patients is due to a lack of sufficient numbers of~     appropriate T cells due to an inadequate source of tumor antigens.~   "
182850|NCT01171456|"~     Gestational diabetes (GDM) represents a significant and growing source nationwide of~     morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are~     complicated by GDM. Infants exposed in utero to hyperglycemia from GDM have an increased risk~     of neonatal complications as well as an increased prevalence of a number of chronic diseases,~     including type 2 diabetes and schizophrenia. Recent research shows that treatment with~     metformin begun as soon as hyperglycemia is detected in pregnancy is safe and effective.~     Additional studies demonstrated that metformin is able to decrease the incidence of type 2~     diabetes among individuals at risk for this disease. Based upon these findings, the~     investigators propose to test the hypothesis that metformin therapy for women at risk for~     gestational diabetes, started prior to conception and before the onset of hyperglycemia, both~     decreases the incidence of and improves the maternal and neonatal outcomes from GDM.~      The investigators intend to conduct a prospective, randomized, double-blind placebo~     controlled range-finding study to measure the effects of early metabolic intervention with~     metformin in women at risk for GDM before the commencement of pregnancy or prior to~     completion of the first trimester. The target sample size for this pilot study is 100 women.~     The effect size observed will provide preliminary data for a subsequent study which will be~     sufficiently powered to detect small or moderate effects from early metabolic intervention in~     women at risk for GDM.~      The specific aims of the proposed research consist of the following:~        1. Determine whether treating women at risk for GDM with metformin prior to conception~          and/or completion of the 1st trimester decreases the incidence of GDM at 26 weeks'~          gestation.~        2. Evaluate the effects on maternal and fetal pregnancy outcomes of pre-conception~          metabolic intervention with metformin in women at risk for GDM.~        3. Use these pilot study results to:~             1. identify specific demographic characteristics associated with an intervention~               effect~             2. calculate effect size for specific outcomes~             3. provide range-finding data for a subsequent study design~      Metformin therapy for women at risk for gestational diabetes, started prior to conception and~     before the onset of hyperglycemia, both decreases the incidence of and improves the maternal~     and neonatal outcomes from GDM.~   "
182851|NCT01171443|"~     Since the pathophysiology of BIPN still remains unclear, in the present study we are going to~     assess the development of BIPN in newly diagnosed myeloma patients, based on clinical~     neurological examination and electrophysiological study (EMG) and trying to find out if there~     is any relationship between oxidative stress generation measured by serum malonyldialdehyde -~     (MDA) and urinary isoprostane, and the development of BIPN, which can explain important part~     of the BIPN pathophysiology and can suggest new ideas of treatment and prophylactic~     strategies of peripheral neuropathy.~   "
182852|NCT01171430|"~     The main objective of this study is to examine if absence of a satisfactory response on~     DCE-WB-MRI (see MR criteria of responders section) after completion of HDT followed by~     autologous stem-cell transplantation (ASCT) is an independent prognostic factor for EFS in~     patients with MM, compared with established ones including beta2-microglobulin and~     cytogenetic abnormalities. Secondary objectives are to examine if the microcirculation~     parameters obtained from baseline DCE-WB-MRI have prognostic significance and to examine if~     early DCE-WB-MRI performed after the induction HDT and before ASCT might also provide~     independent prognostic information for patient outcome, which might help in patient~     stratification and be integrated into the response criteria in the future.~   "
182853|NCT01171417|"~     For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to~     Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). For~     all patients, to collect and explore real-life data on the epidemiology and management of~     Pseudomyxoma Peritonea (PMP) patients with HR+ advanced breast cancer (ABC) treated with~     Faslodex 500 mg or exemestane.~   "
182854|NCT01171404|"~     The aim of this international study is to describe the short- and long-term (i.e. up to 2~     years following the index event) antithrombotic management patterns (AMPs) in patients~     hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction~     (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the~     impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life'~     setting and to compare these between sites, countries and regions.~   "
182855|NCT01171391|"~     The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of~     VA106483 in female subjects.~   "
182856|NCT01171378|"~     The purpose of this study is to evaluate Ofatumumab in combination with CHOP~     (cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and~     prednisone/prednisolone, the standard chemotherapy treatment) in induction and maintenance~     treatment of Richter's Syndrome. This study aims to evaluate the overall response rate to~     CHOP-O (CHOP in combination with Ofatumumab) according to the Revised Response Criteria for~     Malignant Lymphoma. The hypothesis would be that treatment with CHOP-O for Richter's Syndrome~     (RS), shows a difference in overall survival (more people living longer), when compared with~     the standard treatment of CHOP-R (CHOP chemotherapy plus Rituximab).~   "
182857|NCT01171365|"~     The purpose of this study is to determine whether an inhaled steroid with a small particle~     size can be an additional treatment option in patients with refractory eosinophilic asthma.~   "
182858|NCT01171352|"~     Currently, decisions regarding volume management for dialysis sessions in the ICU are made in~     large part on the nephrologists'/intensivists' overall gestalt. This gestalt is based upon a~     combination of commonly used measures of circulatory function, the physical exam, fluid~     balance, estimates of dialysis dry weight, and monitoring changes in relative blood volume~     status using devices such as the Crit-Line™ III, and central venous pressures. However, these~     tools perform poorly in predicting the circulatory system's overall response to dialysis.~     Consequently, episodes of dangerously low blood pressure are still frequently encountered.~     Better techniques to predict the circulatory system's response to dialysis are much needed.~     The intent of this study is to test newer metrics of circulatory system function for their~     ability to predict low blood pressure episodes during dialysis. This is important because it~     may enable the design of newer treatment strategies created to prevent low blood pressure~     episodes during dialysis and improve patient outcomes. The investigators overall hypothesis~     is that newer measures of vascular volume and dynamic indices of fluid responsiveness,~     previously found to better reflect cardiac preload state than currently used parameters, will~     better predict low blood pressure episodes during dialysis than current methods.~   "
190103|NCT01076140|"~     The purpose of this study is to directly compare the blood pressure (hypertension) reduction~     effects of lisinopril and nebivolol in patients who develop new onset or worsening~     hypertension while treated with bevacizumab.~   "
182859|NCT01171339|"~     Objective: To investigate whether the complex intervention will improve the appropriateness~     of prescriptions in elderly multi-morbid patients with multi-medication in general practices.~      Study hypothesis: The primary objective of the study is to determine whether the complex~     intervention will improve the appropriateness of prescriptions compared to usual care. The~     primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score~     from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.~   "
182860|NCT01171326|"~     Impetigo is a common, highly infectious skin disease caused by bacterial infection and~     characterized by crusting skin lesions. It is most common in children, particularly children~     in unhealthy living conditions. In adults, it may follow other skin disorders. Impetigo is~     caused primarily by the bacteria Streptococcus pyogenes and/or Staphylococcus aureus, which~     can also be isolated from impetigo lesions.~      This is a pilot phase II study to evaluate the tolerability and safety and to monitor the~     clinical efficacy of Topical Minocycline Foam FXFM244 in impetigo patients.~   "
182861|NCT01171313|"~     The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in~     comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after~     administration of XP21279/Carbidopa and Sinemet and to explore exposure-response~     relationships in a subset of subjects.~   "
182862|NCT01171300|"~     Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard~     in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by~     extensive surgery regardless of tumor response. The main question is whether extensive~     surgery can be avoided holding in mind that already a significant amount of patients reach a~     pathological complete response after radiochemotherapy. The goal of this study is dual. First~     of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the~     assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select~     those patients eligible for less invasive surgery. In the same patient group, the~     investigators will examine the biomarker potential of molecular characteristics of the tumor~     in blood and tissue. Using both molecular and radiological findings, the investigators want~     to predict pathological response after chemoradiotherapy and to select patients who may~     benefit from treatment adjustments during chemoradiotherapy.~   "
182863|NCT01171287|"~     Research on the implications of orthopedic injury and surgery on automobile driving ability~     has been limited. Only a handful of orthopedic issues have been studied to date, especially~     the safe postoperative resumption of driving. However, effects of orthopedic immobilizations~     of the lower right limb on fitness to drive are largely unknown, and the physician is left~     with little guidance. Only one study (Tremblay et al. 2009) have looked at the impact of~     wearing such devices on braking performances. The results have shown a statistically~     significant increase of braking times while wearing a removable Aircast walker and a walking~     cast in healthy subjects under simulated driving conditions. Despite this, the study have not~     demonstrated that driving with orthopedic immobilization is dangerous since the increase in~     braking times were minimal. Limitations of this study include the important fact that driving~     simulation is not real-time driving. In order to assess the validity of the driving simulator~     used in this study, a similar experimental study during real-time driving was thus devised.~   "
182864|NCT01171274|"~     Hatha Yoga is a traditional system of exercises, used in India for the relief of painful~     condition since centuries and gaining more and more interest in Europe and the US. While~     studies have demonstrated benefits of Hatha Yoga for patients with chronic low back pain, no~     studies regarding chronic neck pain are available until now. The purpose of this study is to~     determine if Hatha Yoga can ameliorate chronic neck pain and related restrictions.~   "
182865|NCT01171261|"~     This is a RWJF funded study that will apply behavioral choice theory and learning theory~     principles to 'map' exergames to determine how behavior change principles influence sustained~     use of health games by adolescents.~   "
182866|NCT01171248|"~     The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP)~     in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation~     between central and peripheral 24 hour BP and a possible association to late complications in~     diabetes.~   "
182867|NCT01171235|"~     The aim of the study is to find for one or more serum or tissue markers of molecular biology~     in head and neck cancer patients used for early diagnosis, predicting prognosis and being~     sensitive to chemotherapy and radiotherapy~   "
182868|NCT01171222|"~     This study shall provide missing descriptive data on health status of veteran players and~     potential preventive effects of soccer at an age of 40 to 60 years. The investigation~     represents a cross-sectional examination of cardiovascular parameters and metabolic stress~     induced by training and competition. Additionally, orthopedic and other medical risks are to~     be revealed, and options should be developed to minimize these risks, e.g. by preventive~     measures included in training or rule modifications.~   "
182869|NCT01171209|"~     The purpose of the study is to determine if Interferon-alfa is effective and safe in multiple~     sclerosis patients who developed neutralizing antibodies for Interferon-beta.~   "
182870|NCT01171196|"~     The purpose of this study is to validate the Berlin questionnaire and STOP-BANG (snore,~     tired, obstruction, pressure, body mass index (BMI), age, neck, gender) as effective~     screening tools for Chinese subjects who are suspected to have obstructive sleep apnea (OSA).~   "
182871|NCT01171183|"~     This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine~     dependent participants.~   "
182886|NCT01170962|"~     The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a~     and ribavirin can result in higher cure rates in patients who previously failed therapy and~     may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.~   "
182914|NCT01170598|"~     Fatigue, reduced quality of life and declines in physical function are common in patients~     undergoing chemotherapy for acute myeloid leukaemia (AML). Studies in other cancer patients~     undergoing treatment have shown that exercise improves these symptoms, but there are limited~     studies in AML. This study of a hospital-based exercise program will help determine if~     exercise is both feasible and helpful in improving symptoms among for AML patients undergoing~     chemotherapy.~   "
190552|NCT01070251|"~     This study investigates whether a preschool-based physical activity intervention involving~     parents as active agents of behavioral change affects objectively measured physical activity~     in preschool children.~   "
182872|NCT01171170|"~     This study is designed to assess the effects of adding nitroglycerin (NTG) patches, delivery~     25 mg NTG per 24 h, to the standard first line treatment of metastatic non-squamous non-small~     cell lung cancer (NSCLC), i.e. 4 cycles of carboplatin-paclitaxel-bevacizumab, followed by~     bevacizumab alone until disease progression. Tumor hypoxia is a common phenomenon in lung~     cancer; it is a known poor prognostic marker, related to treatment resistance. Pre-clinical~     studies have shown that nitric oxide (NO) donating drugs may decrease hypoxia related drug~     resistance. NTG is a NO donating drug. NTG increases tumor blood flow and thereby augments~     antitumor drug delivery to the tumor.~      A randomized phase II has shown an increase in the response rate from 42% to 72%, when NTG~     patches (25 mg/day, day -2 to +3) were added to vinorelbine/cisplatin in patients with~     advanced NSCLC. In addition, the time to progression increased from 185 to 327 days.~      The hypothesis of the present study is that adding NTG transdermal patches to bevacizumab~     containing chemotherapy improves progression free survival, response rate and overall~     survival in patients with metastatic non-squamous NSCLC.~   "
182873|NCT01171157|"~     The purpose of this research study is to estimate how many elderly people who have symptoms~     that look like influenza (i.e. an influenza-like illness) actually have the disease and how~     effective influenza vaccines are in preventing influenza in elderly people. The study will~     also examine the severity of the disease (e.g. how long are people ill, were there any~     complications) and how it affects everyday life (e.g. cost, medications, care by family~     members).~   "
182874|NCT01171144|"~     This study aims at collecting data from secondary sources to obtain baseline incidence and~     monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis~     related hospital discharges and gastroenteritis related deaths in children < 5 years of age~     in Panama before and after implementation of Rotarix™ universal mass vaccination.~   "
182875|NCT01171131|"~     The aim of this research is to determine if the biological fluids (blood/saliva) from chronic~     brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein~     markers. To accomplish this two populations of chronic TBI patients who are receiving~     treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and~     non-penetrating TBI will be studied. Using multiple proteomic approaches including mass~     spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the~     investigators aim to identify biomarkers in the blood/saliva of patients suffering from~     chronic TBI and to determine the similarities/differences between the blast and~     non-penetrating injury groups. Identification of these biochemical changes will give insight~     into the long-lasting changes associated with head injury, and may identify new targets for~     treating the associated pathologies.~   "
182876|NCT01171118|"~     The investigators are attempting to demonstrate a decrease in the frequency and severity of~     sedation-induced respiratory arrhythmias(central and obstructive apneas) with pharmacological~     pre-treatment in this pilot project and then eventually to understand the mechanisms behind~     this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep~     in Obstructed Sleep Apnea (OSA) patients, have not been systematically studied during~     sedation in either normal subjects or OSA patients. The agent to be assessed in this study in~     physostigmine versus placebo.~   "
182877|NCT01171105|"~     1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after~          multiple oral doses.~        2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how~          the study drug enters and leaves your body and how your body acts on the study drug) of~          AZD5213 in your blood and urine.~   "
182878|NCT01171092|"~     The purpose of this study is to determine if the combination of G-CSF and bortezomib is safe~     and effective in blood cell mobilization.~   "
182879|NCT01171079|"~     The purpose of this study is to evaluate the effects and safety of oxidized, regenerated~     cellulose as an absorbable adhesion barrier after thyroidectomy.~   "
182880|NCT01171053|"~     The aim of this study is to investigate the efficacy of a 10 week Internet-delivered CBT~     treatment for patients diagnosed with IBS. The patients' work with the treatment and is~     supported through online contact with a therapist.~      Approximately 86 patients will be included in the study and randomized to either condition.~      All included patients are assessed one week before the treatment starts. After 10 weeks (post~     treatment). Follow-up assessments are conducted at 3 and 12 months follow-up after treatment.~      Patients in treatment condition are hypothesized to experience significant reduction IBS~     symptoms, societal costs and quality of life compared to patients on waiting list.~   "
182881|NCT01171040|"~     Left ventricular filling pressure (LVFP) has prognostic significance in patients with heart~     failure. Traditionally, it should be assessed by invasive method, as cardiac catheterization~     and Swan-Gung catheter. In advance of new techniques and modality, echocardiography provides~     some useful parameters for assessing LVFP, such myocardial tissue Doppler imaging. Many~     articles had documented that peak velocity of early-diastolic trans-mitral inflow velocity~     divided by early-diastolic velocity over mitral annulus correlated closely to LVFP. However,~     myocardial tissue Doppler only provides the information of regional myocardium, so patients~     with regional wall motion abnormality, as coronary artery disease, can't be assessed by this~     method without handicap. In addition, conduction disturbance, like bundle branch block, also~     influences the result of myocardial tissue Doppler. For resolving those problems, the~     investigators had designed a new global parameter to assess LVFP. In the investigators prior~     study, left atrial distensibility correlated logarithmically to LVFP in patients with severe~     mitral regurgitation and also in patients with acute myocardial infarction. Left atrial~     distensibility provided a new viewpoint to assess left ventricular diastolic function and to~     predict prognosis. This time, to extend left atrial distensibility to general population~     received echocardiographic examination for predicting prognosis is attempted.~   "
182882|NCT01171027|"~     This study is designed to be a United States multicenter prospective randomized controlled~     non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal~     Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in~     elective surgery patients. Up to 200 patients will be enrolled to obtain 70 NOTES~     cholecystectomies (35 transgastric and 35 transvaginal) and 70 laparoscopic cholecystectomies~     on a randomized basis. In order to evaluate the hypothesis that NOTES cholecystectomy has~     equivalent safety and efficacy to laparoscopic cholecystectomy, clinical and administrative~     outcomes will be measured.~   "
182887|NCT01170949|"~     Randomised, double-blind, placebo-controlled study evaluating the effects of miltefosine on~     skin lesions in patients with treatment resistant chronic urticaria. Treatment resistance is~     defined by insufficient treatment response after a minimum of 1 week therapy with the maximum~     labelled dose of a non-sedating antihistamine. Eligible subjects will be enrolled at baseline~     8 (+/- 1) days after screening. 75 Patients will be randomised in a 2:1 ratio to one of the~     following treatment groups as add-on to the ongoing therapy with a non-sedating antihistamine~     for treatment period of 4 weeks: 25 placebo and 50 active drug Efficacy and safety~     evaluations are done at baseline day 7, 14, 21 safety, only) and 28 (or end of treatment) and~     at day 56 (28 days after end of treatment).~   "
182888|NCT01170936|"~     This is a single-center open label study to assess the efficacy and safety of single doses of~     canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes IL-1β,~     in patients with active urticarial vasculitis. Efficacy is primarily assessed by a combined~     symptom score, the urticarial vasculitis activity score (UVAS). Following a baseline period~     of 2 weeks, patients will be dosed with two single s.c. injections of 150 mg (consistent with~     a total dose of 300 mg canakinumab). Visits for investigator's assessments will be scheduled~     at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks post dose. Patient's~     self-assessment will be performed on a daily basis throughout the study. Overall a max. of 10~     subjects with urticarial vasculitis will be enrolled.~   "
182889|NCT01170923|"~     The usual response to chemotherapy is decided through the image change by computed tomography~     (CT), which is taken at least 6-9 weeks.~      In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at~     the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET~     scan.~   "
182890|NCT01170910|"~     Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to~     improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow,~     pressure, resistance index, venous effluent pH) are correlated with better recovery of renal~     function (without dialysis during the first week after transplant).~      Observation or Investigation Method Used :~      The study is multicenter, prospective, open, controlled and randomized:grafts are divided~     into two parallel groups:~        -  group 1 corresponds to a conservation of grafts in static incubation~        -  group 2 corresponds to conservation using a pulsatile perfusion machine~      Duration and Organizational Arrangements for Research :~      The total duration of the study is planned for 36 months. This duration includes:~        -  an inclusion period that will last 24 months,~        -  the follow-up of recipient patients from the day of transplantation until twelve months~          after the operation~   "
182891|NCT01170897|"~     This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic~     and pharmacodynamic study in patients with advanced solid tumors.~   "
182892|NCT01170884|"~     Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or~     Ocular Hypertension Subjects Treated with Xalatan®.~   "
182893|NCT01170871|"~     The purpose of the study is to determine the maximal tolerated dose (MTD) of Ixabepilone and~     Pemetrexed in advanced solid tumors and to obtain preliminary information regarding the~     activity of this combination.~      This research study is for research participants who have confirmed metastatic or~     unresectable solid tumors (lung, breast, ovary, cervix, uterus, mesothelioma, and prostate)~     for which standard curative or palliative measures do not exist or no longer effective.~   "
182894|NCT01170858|"~     Peritoneal dialysis (PD) is an established dialysis modality in patients with end stage renal~     disease (ESRD). However, there is growing awareness of the deleterious effect of high glucose~     content in PD solutions on the peritoneal membrane over time (1). Accordingly, development of~     new solutions to minimize glucose-induced toxicity and/or containing an alternative osmotic~     agent to glucose such as icodextrin and amino-acid were developed. Icodextrin is a mixture of~     high molecular weight, water soluble glucose polymers isolated by fractionation of hydrolyzed~     cornstarch (2). Unlike glucose which is absorbed from the peritoneal cavity primarily by~     diffusion across the peritoneal capillary endothelium, its absorption occurs mainly due to~     convective fluid movement out of the peritoneal cavity via the lymphatics (2). As a result,~     relatively constant osmotic pressure is created by icodextrin, thus it can provide sustained~     ultrafiltration during the long dwell.~      A number of studies have reported that icodextrin-based solution provides various clinical~     benefits compared with conventional glucose-based solutions (3-7). In particular, icodextrin~     has been successfully used in the fluid management of PD patients (4-5, 7). However,~     excessive ultrafiltration may induce underhydration, resulting in faster decline in residual~     renal function. This concern was first raised by Konings et al (8). In this study, a greater~     fall in residual glomerular filtration rate (GFR) was observed in patients using icodextrin~     compared to those using 1.36% glucose solution. In contrast, contradictory findings were also~     reported from the two studies indicating that residual renal function can be preserved by~     icodextrin solution (4, 9). Although the mechanisms are not clear, possible explanation~     includes the presence of high-molecular-weight icodextrin metabolites in plasma, which in~     turn may increase plasma oncotic pressure and hence preserve plasma volume and renal~     perfusion as suggested by Davies et al (10). Such discrepant findings may be explained by~     differences in study design, baseline fluid status, and other factors affecting residual~     renal function during the study. In the study by Konings et al (8), the comparative solution~     was 1.36% glucose, whereas 2.27% glucose was used in the study by Davies et al (4).~     Therefore, it can be speculated that volume status might differ depending on different~     concentration of glucose solution, thus leading to conflicting results. Also, these two prior~     studies are limited by residual renal function as secondary outcome, a short follow-up~     duration (4 mo vs. 6 mo), and small number of patients (32 vs. 50).~      To further explore the effects of icodextrin solution on residual renal function, the~     investigators will conduct a multicenter prospective randomized controlled open-label trial.~     Briefly, incident or prevalent adult CAPD patients with residual urine volume > 750 ml will~     be included. Patients on APD will be excluded. After a 4-week screening period, patients will~     be randomly assigned to icodextrin or 2.5% glucose solution for the long dwell. Residual GFR~     and fluid status will be assessed at baseline, 6, and 12 months. Residual GFR will be~     calculated as an average of urea and creatinine clearance from a 24-hour urine collection. To~     assess fluid status, the investigators will use three different assessment tools; 1)~     echocardiography for measuring intra vena cava (IVC) diameter and left ventricular end~     diastolic diameter, 2) measurement of plasma atrial natriuretic peptide, 3) bioimpedence~     analysis. Primary outcome is residual GFR change at 1-year and secondary outcome is change of~     fluid status during the study period. Also, biochemical laboratory data such as hemoglobin,~     hsCRP, plasma osmolality, and lipid profile, peritoneal equilibration test, dialysis~     adequacy, and daily peritoneal glucose exposure will be monitored. At least 50 subjects (a~     total of 100) would be required for each group to detect 50% difference of residual GFR~     between the two groups if type I error rate is 5% and type II error is 20% given 30% of~     drop-out rate during the study period.~      Preservation of residual renal function is of paramount importance because it is an~     independent risk factor of mortality in PD patients. In addition, achievement of adequate~     ultrafiltration is another crucial therapeutic goal to improve clinical outcomes in these~     patients. In this regard, if these two goals can be accomplished by icodextrin, it would be~     an ideal dialysis solution in PD practice. The investigators study will address this issue to~     answer the unresolved question on the effect of icodextrin on residual renal function.~   "
182895|NCT01170845|"~     A neutrophil elastase inhibitor may have effect on suppression of the lung injury after~     thoransthoracic esophagectomy. The investigators hypothesized that postoperative~     complication, particularly respiratory complication may be reduced by neutrophil elastase~     inhibitor after esophagectomy.~   "
182896|NCT01170832|"~     This proposal will test if, in patients with type 1 diabetes, wide blood glucose fluctuations~     lead to the injury to heart nerves , called cardiac autonomic neuropathy (CAN), and to~     impaired heart contractile (pumping) function and heart failure. It will also evaluate the~     natural history of heart failure and enhanced cardiac risk in patients with type 1 diabetes~     in the current standard of diabetes care.~   "
182897|NCT01170819|"~     To compare the efficacy of transcervical double balloon catheters versus controlled release~     dinoprostone vaginal inserts for pre-induction cervical ripening in term women with~     unfavourable cervices.~   "
182898|NCT01170806|"~     Obesity is a chronic condition with fat-rich diets playing a major role in its etiology.~     Pharmacological therapy has been proposed for weight loss and maintenance. This study aims to~     study the intestinal lipase blockade by partial inhibition of fat absorption after treatment~     with two commercials formulations of Orlistat.~   "
182899|NCT01170793|"~     In patients with MOH, we will evaluate the impact of educative telephone coaching on the~     number of days with headache over the month preceding the appointment. The educative coaching~     will be administered by a nurse, during a single phone call and prior to the medical visit~   "
182900|NCT01170780|"~     Does corticosteroid (dexamethasone) have an effect on the postoperative period after~     laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and~     convalescence. This randomized, double-blinded study compares dexamethasone versus placebo.~     The patients are recommended one day of convalescence. The medicine or placebo is given~     before operation. The patients fill out questionnaire before operation and three hours after~     operation and in the following three days. The patients also register when they return to~     normal activities and work.~   "
182901|NCT01170767|"~     Age Related Macular Degeneration (AMD) is the first cause of visual impairment in elderly~     patients in industrialized countries. Neovascular or wet AMD, characterized by the presence~     of choroïdal neovessels, represents the most aggressive form of the disease. Its prevalence~     is 3.3% among patients older than 65 years in Europe, and increases with age.~      Intraocular injections of anti-angiogenic monoclonal antibodies (ranibizumab) to treat AMD~     have appeared recently. It is derived from a larger sized molecule, bevacizumab, which do not~     have the market authorization for this indication. However, numerous publications of case~     series seem to show the effectiveness and a satisfactory safety profile of bevacizumab.~      These conclusions have to be confirmed with a high level of evidence study. The aim of the~     GEFAL study is to demonstrate non-inferiority of effectiveness in clinical terms after 12~     months of treatment with bevacizumab compared to ranibizumab on the visual acuity of patients~     affected by neovascular AMD.~   "
182902|NCT01170754|"~     A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for~     colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets~     Phosphosoda) are now used on a limited basis because of their known association with renal~     injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely)~     has been used for over two decades for colon cleansing. The mixture is not very palatable due~     to the electrolyte additives which include sodium sulfate.~      To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons~     worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not~     mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of Gatorade.~     Conservatively, we estimate that 25% of colonoscopies in the US are being done with this~     prep. Anecdotally there have been reports (case series) that it is far more palatable and the~     prep is equally efficacious. The active ingredient, PEG, is not changed and therefore this is~     not surprising. The issue at present is that there has never been a blinded study to confirm~     these claims.~      This study will compare the efficacy of the two preps. There is no funding. The investigators~     will charge insurance companies for the prep - this is our current practice. The procedures~     will be done on healthy individuals referred for colon cancer screening and the exam will be~     billed to their insurance. There will be no patient honorarium. The investigators will check~     electrolytes to be sure patients do not develop hypokalemia with the Gatorade prep.~   "
182903|NCT01170741|"~     This study will draw from proven interventions to refine and pilot test a cue card driven~     computer-assisted intervention, along with HIV/STI testing, that will be tailored to each~     participant's demographic characteristics, risk behaviors, and biological test results. The~     specific aims of the proposed study are:~        1. To refine a cue card driven computer-assisted risk reduction intervention that will be~          tailored to each participant's demographic characteristics (e.g., gender, ethnicity),~          risk behaviors, and biological test results (HIV, hepatitis B and C, syphilis and~          herpes).~        2. To pilot test the tailored intervention's effects on sexual risk behaviors (e.g.,~          frequency of unprotected sex, condom use), drug use during sex and injection risk~          behaviors (e.g., direct syringe sharing, indirect sharing practices) using a two-group~          randomized design that compares the tailored intervention with a delayed treatment~          control condition.~        3. To assess the feasibility and acceptability of the tailored intervention in a rural~          setting.~   "
182904|NCT01170728|"~     This study is a multi-center study that will assess the efficacy and safety of suture~     fixation of the Virtue® Male Sling.~   "
182905|NCT01170715|"~     Psoriasis is a chronic relapsing prevalent inflammatory disease affecting 2-4% of the world's~     population. Severe psoriasis is a disabling disease affecting the physical and emotional well~     being of patients, and its effect on quality of life is similar to that seen with other major~     medical diseases such as diabetes, rheumatoid arthritis, and cancer. Lately, it is~     increasingly being recognized that psoriasis is not merely a skin disease but is probably~     associated with other co-morbidities such as psoriatic arthritis, Crohn's disease, the~     metabolic syndrome and cardio-vascular diseases (CVD). The metabolic syndrome is a~     combination of diabetes mellitus type II (or insulin resistance), hypertension, central~     obesity, and combined hyperlipidemia (elevated LDL; decreased HDL; elevated triglycerides).~     As the literature linking psoriasis and the metabolic syndrome expands, also reports of an~     increased rate of CVD mortality in psoriasis patients accumulates. These data emphasize that~     metabolic dysregulations are the leading risk factors for occlusive vascular events and early~     death in patients with severe psoriasis. Progress in understanding the pathogenesis of these~     apparently diverse diseases has discovered that low-grade systemic inflammation might be the~     common physiological pathway that may provide the biological plausibility of the associations~     discovered in the epidemiological studies. Since some of these co-morbidities often become~     clinically apparent years after the onset of psoriasis we assume that controlling systemic~     inflammation might prevent or reverse some of these co-morbidities.~      Presently there is no study in psoriasis that shows that a systemic co-morbidity can be~     prevented or treated by reversing skin inflammation.~   "
182906|NCT01170702|"~     Since there have been no published dose-response studies investigating the effective~     analgesic dose of ropivacaine for use in a TAP block for post-Cesarean delivery analgesia,~     the investigators propose a study primarily examining the effect on 24 hour post-Cesarean~     delivery opioid consumption of using either a placebo, 0.25% ropivacaine, 0.5% ropivacaine,~     or 0.75% ropivacaine for TAP blocks.~   "
182907|NCT01170689|"~     This study is the first hospital-based, cross-sectional study to discuss the prevalence of~     obesity among 710 inpatients with schizophrenia.~   "
182908|NCT01170676|"~     This is a research study that compares the effectiveness of a web-based program (known as~     Puff City) and another web-based program (of internet sites such as the American Lung~     Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key~     asthma management issues among rural youth:~        1. Improving adherence to asthma controller medication use;~        2. Improving compliance of carrying a rescue inhaler at all times for use at the first sign~          of asthma symptoms;~        3. Improving inhaler technique;~        4. Smoking reduction or cessation in those who are smokers; and~        5. Avoidance of second-hand smoke exposure.~   "
182909|NCT01170663|"~     This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating~     the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared~     to paclitaxel plus placebo.~   "
182910|NCT01170650|"~     The purpose of this study is to compare progression-free survival (PFS) (based upon~     investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian~     cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin~     (EC145+PLD) with that in participants who receive PLD and placebo.~   "
182911|NCT01170637|"~     The objective of the current study is to demonstrate bioequivalence of a fixed dose~     combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg (Test) and~     RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg and~     pseudoephedrine-HCl 30 mg following orally administration.~   "
182912|NCT01170624|"~     The purpose of this study is to evaluate the performance of advanced features, that have been~     implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual~     Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities~     (PARADYM CRT System, model 8750) in a general ICD population.~   "
182915|NCT01170585|"~     Systemic Lupus Erythematosus (SLE) is a condition that affects the whole body. It can cause~     inflammation of the blood vessels resulting in an earlier thickening and hardening of the~     arteries resulting in strokes. It has been reported that SLE can worsen the function~     resulting in heart failure.~      The aim of the study is to examine what effects Rosuvastatin, a cholesterol lowering drug,~     given to patients has on the degree of thickening of the arteries over the course of two~     years. We also want to see how it affects the function of the blood vessels and also of the~     heart.~      Individuals who agree to participate will be randomly assigned into two groups. One group~     will be given the active drug whereas the other will have a placebo. Subjects in the study~     will all have a cardiac magnetic resonance (CMR) scan before treatment, at 1 year and then 2~     years at the end of the treatment. Each scan will involve imaging the carotid arteries in the~     neck, the arteries in the arm and also the heart. Individuals will continue to have regular~     out-patient reviews by their own team of doctors, regular blood tests will be taken to~     monitor the disease and also to ensure the safety and well being of the individual.~      At the end of the 2 year study we hope that we will be able to slow down the rate of arterial~     thickening and retard any plaque build up in the arteries. We also want to see what effect~     rosuvastatin has on heart function. Ultimately, we hope to prove that people with SLE should~     be treated with a cholesterol lowering drug as part of their routine treatment.~   "
182916|NCT01170572|"~     Studies in chickens show that blood levels of a particular form of vitamin D (called~     24,25-dihydroxvitamin D) increase after bone fracture. Laboratory studies show that this form~     of vitamin D helps the bone healing process in chickens. The investigators want to find out~     whether blood levels of this form of vitamin D increase after bone fracture in humans.~     Previous research studies have not addressed this question. The results of this research~     could eventually lead to the development of new treatments to help bone healing after~     fracture.~      Patients will be asked to take part in this study if they are aged 16 years or older and come~     to the Royal London Hospital with a broken bone in the arm or leg or collar bone (clavicle).~     They will be asked to give a 20ml (about 4 teaspoons) blood sample on three occasions: at the~     start of the study, at 5-14 days after the fracture; and at 4-10 weeks after the fracture.~     The rest of their normal care would not be affected. Follow-up blood samples will be timed to~     coincide with routine clinic visits which are scheduled as part of normal clinical care.~     Patients' vitamin D level will be measured as part of the study, and those who have a low~     vitamin D level will be informed about this, and advised about appropriate vitamin D~     supplementation. The investigators will let the patient or their GP know if any blood tests~     are abnormal~   "
182917|NCT01170559|"~     Heart rhythm abnormalities underlie one of the common presenting complaints to the A&E and~     out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG~     (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having~     symptoms, it is very difficult to determine the cause of the palpitations. The conventional~     approach is to refer these patients from the emergency departments to the Cardiology~     outpatients where they undergo repeated short term rhythm monitoring hoping to record the~     rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus~     delaying definitive treatment and incurring extra costs of repeated investigations and A&E~     presentations. This study aims to compare the ability of the conventional approach to~     establish a definite diagnosis compared to that of an early invasive monitoring approach with~     a small implantable device that records the heart rhythm at all time for up to 18 months.~   "
182918|NCT01170546|"~     Question: To investigate how different modes of thigh muscles strengthening exercises~     emphasizing the knee internal rotators can be as effective as possible in improving the~     static stability and agility of the knees with anterior drawer laxity.~      Design: Randomized controlled clinical trial.~      Participants and Interventions:~      Young men with anterior drawer laxity of the knee were randomly assigned to three~     experimental groups in different strengthening modes: plate-loaded squat press (SP),~     plate-loaded kneeling leg curl with internal rotation (KLCIR), and kneeling leg curl (KLC).~     The control group with stable knees received no training.~      Outcome measures: static and dynamic knee stability, isokinetic strength. The purpose of this~     paper was to find out an optimal solution to the enhancement of the static and dynamic knee~     stability to a great extent.~      Key words: anterior cruciate ligament; agility; knee stability; hamstring; knee internal~     rotator~   "
182919|NCT01170533|"~     Clopidogrel, in combination with aspirin, is currently the recommended treatment for~     secondary prevention of ischemic events in high-risk patients and for prevention of coronary~     artery stent thrombosis. Patients receiving aspirin and clopidogrel are frequently treated~     with proton pump inhibitors, such as omeprazole or pantoprazole, in order to prevent the risk~     of gastrointestinal bleeding, accorded to guidelines. An interaction between proton pump~     inhibitors and clopidogrel has been suggested, which may lead to a decrease of clopidogrel~     effects. It remains unclear whether this interaction between PPIs and clopidogrel might be a~     class effect or if this may be affected by timing regimen.~      The objectives of this two-phase investigation are:~        1. to compare clopidogrel platelet inhibitory effects when taken at the same time versus~          separated at least 8 hours from omeprazole administration.~        2. to compare clopidogrel-induced inhibitory effects when taken at the same time versus~          staggered at least 8 hours from pantoprazole administration.~   "
182920|NCT01170520|"~     The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and~     effective add-on therapy for resistent depression in adolescent patients.~      A group of adolescents suffering from non psychotic major depression that was resistant to at~     least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent~     procedure for both parents and patients, patients will go through a clinical and cognitive~     evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure~     of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30~     sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.~   "
182979|NCT01169740|"~     Prospective comparison of measurement of bilirubin in jaundiced newborns by a transcutaneous~     device (bilirubinometer) and laboratory analysis of blood samples.~      We hypothesise that correlation of the two measurements depend on bilirubin level,~     gestational age as well as postnatal age.~   "
182980|NCT01169727|"~     The purpose of this study is to evaluate health status of uncontrolled Chronic Obstructive~     Pulmonary Disease (COPD) patients in response to treatments in clinical practice.~   "
182921|NCT01170507|"~     Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of~     vitamin D status. The determination of the appropriate dose of vitamin D supplement is~     essential for management of vitamin D deficiency as well as for designing vitamin D~     fortification programs. The increments in 25 OH vitamin D levels following various doses of~     vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level~     have not been well defined. The time course of depletion of repleted vitamin D stores is also~     not known.~      The investigators plan to conduct a double blind randomized study on 9 cohorts to determine~     levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5~     months and their withdrawal for 3 months.~   "
182922|NCT01170494|"~     Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of~     vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or~     large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2~     compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining~     total 25 OH vitamin D level.~      The investigators plan to conduct a controlled trial to compare the effect of various vitamin~     D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level~     between 20 to 50 nmol/L.~   "
182923|NCT01170481|"~     Assessment of optic disc morphology can be difficult in patients with uveitis and~     papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning~     techniques may help to detect damage to the retinal nerve fibre layer.~   "
182924|NCT01170468|"~     Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status~     has been negatively associated with the presence of type II DM and glycemic control. A~     cause-effect relationship between vitamin D deficiency and the development of type II DM has~     not been established.~      The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled~     trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk~     individuals.~   "
182925|NCT01170455|"~     The purpose of this study is to determine whether nasal tracheal intubation using Blind~     Intubation Device is safe and effective in anesthetized patients with Mallampati class 3~   "
182926|NCT01170442|"~     Vitamin D status has been negatively associated with the presence of type II DM and glycemic~     control. However, a cause-effect relationship between vitamin D deficiency and glycemic~     control has not been established. The investigators plan to conduct a double blind,~     randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic~     control in Type II DM.~   "
182927|NCT01170429|"~     The purpose of this study is to investigate the efficacy and safety of procaterol~     hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma~     (CVA).~   "
182928|NCT01170416|"~     Patients sometimes suffer from life-threatening abnormal heart racing that originates from~     the lower chamber of the heart. These patients will often need an implantable defibrillator~     which has the ability to shock the heart back to a normal heart rhythm, but this does not~     prevent them from getting frequent recurrences of the bad heart rhythm needing shocks from~     the device. This can be painful and potentially harmful. Medicines to prevent recurrences of~     shocks are not very effective and have many side effects. An alternative to medicines for~     this is a procedure called a catheter ablation in which a wire is passed up through the blood~     vessels of the leg into the heart and used to find the short circuits which cause the~     dangerous heart rhythm. When the spot causing the trouble is found, the investigators can~     burn it (ablate it). This procedure is challenging and methods are needed to make it more~     effective and easier to do. One of the main ways for finding the short circuits involves~     using the electrocardiogram (the ECG). The regular ECG is simplistic and only makes use of~     recordings from 10 sites (6 precordial sites and 4 sites on both upper and lower limbs) on~     the body surface. The investigators are testing whether making recordings from 120 sites on~     the chest and back and using special computerized analysis of the recordings can help make~     catheter ablation for dangerous heart rhythms more effective.~   "
182929|NCT01170403|"~     64 channel multidetector-row Computed Tomography (CT) has been introduced for use in the~     diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery~     disease in type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures~     depending on different status of metabolic diseases. The investigators also aimed to analyze~     the risk factors associated with number and severity of stenosis as well as plaque~     characteristics using logistic regression models.~   "
182930|NCT01170390|"~     The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral~     contraceptive metabolism in a manner which results in decreased effectiveness in obese women.~   "
182931|NCT01170377|"~     The aim of this study is to evaluate the effect of valproate on the required dose of propofol~     for sedation in patients with mental retardation.~   "
182932|NCT01170364|"~     Obesity is a major public health concern, and the search for useful pharmacologic~     interventions is ongoing. This study aims to develop a comprehensive series of assessments to~     directly assess eating behavior, cognitive functioning, and psychological functioning under~     sibutramine and placebo conditions.~   "
182933|NCT01170351|"~     Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are~     corticosteroids (CS). In addition to being ineffective a substantial minority of cases,~     corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options~     for induction of remission are limited. There are reports of successful salvage therapy with~     Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have~     shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies~     comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy~     and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH~     patients.~   "
182934|NCT01170338|"~     Assess the role of a nicotine antagonist in helping patients presenting to hospital with~     acute coronary syndrome to stop smoking.~   "
182981|NCT01169714|"~     This study is designed to observe the safety and blood concentrations of PF-04995274 during~     and following the administration of multiple doses of PF-04995274 for a duration of 14 days,~     in healthy adult and healthy elderly.~   "
182982|NCT01169701|"~     The objective of the study is to compare the cardiovascular profile of an everolimus and~     mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic~     acid regimen in maintenance renal transplant patients~   "
182935|NCT01170325|"~     Background:~        -  Electroencephalography (EEG) records electric patterns produced by the brain, and can~          detect conditions such as epilepsy or other l abnormalities that may affect brain~          function. In EEG studies, electric patterns that resemble epileptic seizures are known~          as epileptiform pattern. These patterns are associated with an increased risk of~          seizures, even in people who have not been diagnosed with epilepsy. Epileptiform~          patterns also appear on the EEGs of some children who have autism spectrum disorders but~          do not have epilepsy. It is unclear if these discharges are related in any way to the~          symptoms of autism (behavior, language or intellectual abilities).~        -  Divalproex sodium (Depakote) is a drug that has been used for many years to treat~          epilepsy and other brain disorders in children and adults. Researchers are interested~          determining whether treatment with divalproex sodium can reduce epileptiform patterns in~          children with autism spectrum disorders, and in doing so study whether this treatment~          can improve behavior, language or cognition in children with autism spectrum disorders.~      Objectives:~      - To study the effectiveness of using divalproex sodium to reduce epileptiform EEG discharges~     in children with autism spectrum disorders.~      Eligibility:~      - Children between 3 and 10 years of age who have an autism spectrum disorder and show~     frequent epileptiform discharges on an overnight EEG.~      Design:~        -  This study will last for a total of 9 months, with 6 months of treatment with either~          divalproex sodium or a placebo followed by 3 months of treatment with divalproex sodium~          only.~        -  Potential participants will be screened with a physical examination and medical history,~          blood samples, and psychological tests, and will spend the night in the NIH Clinical~          Center to have an overnight EEG. Children with frequent epileptiform abnormalities on~          the EEG will continue with the study; all others will be considered ineligible.~        -  Eligible participants will receive either divalproex sodium or a placebo to be taken~          twice daily for 24 weeks. Neither the investigators nor the participants will know which~          they are taking.~        -  Participants will have regular visits (every 2-4 weeks) to monitor for adverse effects~          and to test for possible behavioral improvement, and will also have overnight EEG~          testing at 12 and 24 weeks.~        -  At the end of the 24-week study period, participants will have the option to have an~          additional 12 weeks of treatment with divalproex sodium.~        -  A final evaluation (including EEG) will be conducted at the end of the final treatment~          period.~   "
182936|NCT01170312|"~     Rotator cuff tears are a common injury that lead to pain and loss of function for those who~     suffer from it. Treatment includes the use of arthroscopic surgery to return function to the~     patient and reduce their pain. This study is interested in a technique that has the potential~     to improve patient outcomes in terms of less pain and better function after their surgery.~     Autologous Conditioned Plasma (ACP) or Platelet Rich Plasma (PRP) is the intervention of~     interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a~     high concentration of cells called platelets. Platelets release growth factors important for~     healing, as well as fibrin, which acts like a biological glue. The PRP is then re-injected~     into the shoulder at the time of surgery and again at 4 weeks. It has been shown to~     accelerate healing in other studies for injuries such as chronic elbow tendinopathy, but~     there is no randomized controlled trial that evaluates the effect of PRP in rotator cuff~     tears. It is on this basis that the study is being performed. Participating patients will~     receive either a PRP injection or a placebo (normal saline) and the effects will be compared~     at 2 weeks, 4 weeks, and 6 weeks based on a pain score and return to function questionnaires.~     The primary hypothesis for this study is that ACP compared with placebo is effective in~     reducing pain at the site of a rotator cuff injury that has undergone arthroscopic repair. It~     is expected that ACP administered during surgery and 4 weeks post-surgery will reduce 6-week~     pain scores compared to the placebo group.~   "
182937|NCT01170299|"~     RATIONALE: Fiber may lessen bowel side effects caused by radiation therapy. It is not yet~     known whether a high-fiber diet is more effective than a low-fiber diet in preventing bowel~     side effects caused by radiation therapy.~      PURPOSE: This randomized clinical trial is studying a high-fiber diet to see how well it~     works compared with a low-fiber diet in preventing bowel side effects in patients undergoing~     radiation therapy for gynecological cancer, bladder cancer, colorectal cancer, or anal~     cancer.~   "
182938|NCT01170286|"~     The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated~     epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device)~     in peanut allergic subjects.~   "
182939|NCT01170273|"~     Vitamin D insufficiency is a problem of growing concern, given its prevalence in older~     persons and the association of low vitamin D with multiple major health problems, including~     mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain~     cancers. Sedentary persons are particularly vulnerable for these health problems and~     generally not adherent to prescribed physical activity. This study will investigate if~     treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.~   "
182940|NCT01170260|"~     This research is studying behaviors that young people engage in that may place them at risk~     for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational~     program works best to reduce these risky behaviors.~   "
182941|NCT01170247|"~     The purpose of this study is to determine if intranasal ketamine is equally as effective and~     safe as intramuscular ketamine for procedural sedation in pediatric patients.~   "
182942|NCT01170234|"~     There is currently no reliable, noninvasive biomarker for eosinophilic esophagitis (EoE), a~     chronic allergic diseases characterized by significant infiltration of eosinophils in the~     esophagus. Because eosinophils release nitric oxide, levels of exhaled nitric oxide (FeNO)~     are used routinely for guiding treatment in subsets of patients with asthma. FeNO levels are~     also elevated in immunological diseases that do not involve the airways. The investigators~     hypothesize that patients with EoE have elevated nitric oxide concentration in their exhaled~     breath and that changes in FeNO levels could be used to measure disease activity. The~     objective of this study is to determine the feasibility of using FeNO as a noninvasive~     surrogate marker for EoE disease activity. The investigators propose to measure serial~     exhaled nitric oxide (FeNO) levels on a group of patients with confirmed EoE, before, during~     and after the course of topical corticosteroid therapy to determine whether the level~     declines from pre-treatment level in individual patients.~   "
182943|NCT01170221|"~     This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA~     200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days~     for the treatment of ABSSSI in adults.~      Approximately 75 to 100 sites globally will participate in this study. Patients with an~     ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be~     randomized 1:1 to study treatment~   "
182983|NCT01169688|"~     This study was done to compare efficacy, safety and efficiencies of various methods of pupil~     dilation prior to cataract surgery.~   "
182985|NCT01169662|"~     Nitrate provides the body with an alternative source of Nitric Oxide which plays a large role~     in promoting blood flow and reducing blood pressure. Nitrate supplementation with~     vegetable/fruit juice has recently been shown to reduce blood pressure and reduce energy~     expenditure during low intensity exercise. Such findings combined with the previously known~     biological effects of nitric oxide would suggest that nitrate supplementation would also~     impact on blood flow. The aim of this study is to examine the effects of dietary nitrate~     supplementation via vegetable/fruit juice drink on cerebral (brain) blood flow (using Near~     Infrared Spectroscopy).~   "
182944|NCT01170208|"~     The purpose of the study is to determine the effectiveness and safety of the computer~     software program in providing insulin dosage recommendations. Participation in the study for~     60 research subjects will last for 16-weeks and includes 3-4 clinic visits and a series of~     weekly telephone calls from the study team (minimum of 12 calls). Participants will be~     provided with weekly Study Log Sheets to record their daily blood glucose readings, insulin~     doses, grams of carbohydrate eaten at each meal (if they have type-1 diabetes) and any~     changes in their health (e.g., hypoglycemic episodes, illnesses). Participants will fax or~     drop off a copy of the Study Log Sheet. This information will be entered by the IDC study~     team into the computer software program. The IDC study team will review the information from~     the software and, based on the IDC's study team approval, any insulin dose changes will be~     communicated back to the patient by phone or fax.~   "
182945|NCT01170195|"~     The purpose of the proposed study is to test the effect of Licorice Root Extract- Licogen on~     postmenopausal symptoms in postmenopausal women. Specifically, the study will also test the~     effect of the licorice extract on vaginal dryness.~   "
182946|NCT01170182|"~     This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules~     under fed condition.~   "
182947|NCT01170169|"~     This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules~     under fasting condition.~   "
182948|NCT01170156|"~     The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs~     is usually considered as a major risk factor for bacterial tracheal colonization and~     subsequent development of ventilator-associated pneumonia. The rate of leakage around the~     cuff is related to the pressure differential across the cuff, namely the difference between~     the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff.~     Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff~     towards fluid leakage. However, this preventive effect of PEEP is compromised during~     prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid~     leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning~     manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a~     high-volume low-pressure tracheal tube cuff when performed with a high level of suction~     pressure (- 400 mbar) and a large size of suction catheter size (16 French).~   "
182949|NCT01170143|"~     To compare the efficacy in terms of the pathological complete response rate (pCR) to~     preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH)~   "
182950|NCT01170130|"~     The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine~     1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving effective~     mydriasis during phacoemulsification surgery.~   "
182951|NCT01170117|"~     Anorexia Nervosa (AN) is a serious illness associated with substantial morbidity and~     mortality. Weight restoration is a treatment priority, and better treatments are needed.~   "
182952|NCT01170104|"~     To evaluate the time to progression of the combination therapy of Transcatheter Arterial~     Chemoembolization (TACE) and sorafenib in patients with previously untreated advanced or~     metastatic hepatocellular carcinoma.~   "
182953|NCT01170091|"~     Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome~     Patients: An Open-Label, Postmarketing Surveillance Study~   "
182954|NCT01170078|"~     This study assessed the comparability of the pharmacokinetics (PK) of epoetin following~     intravenous administration of Hospira Epoetin and Epogen/Epoetin Alfa (Amgen) in patients~     with chronic renal failure receiving hemodialysis treatment.~   "
182955|NCT01170065|"~     The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with~     Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.~      The primary objective will be to establish the long term tolerability and safety profile of~     BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).~      As a secondary objective the effects of long term treatment with BIBF 1120 on survival as~     well as safety and efficacy parameters will be investigated in an open-label, not randomized,~     un-controlled design.~   "
182956|NCT01170052|"~     The purpose of this study is to assess the safety, tolerability and activity of the~     combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell~     lymphoma who are not eligible for high dose chemotherapy and autologous/allogeneic stem cell~     transplantation.~   "
182957|NCT01170039|"~     The investigators will recruit a total of 136 diabetic men and women with constipation into~     this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The~     investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours~     after initiation of study drug (SBMs) in all patients two weeks before treatment with~     lubiprostone as well as measure baseline colonic transit using the Smartpill pH capsule.~     Colon transit reflects that rate of colonic peristalsis and movement of stool through the~     large bowel.~      Patients will receive either lubiprostone 24 micrograms (mcg) orally twice a day for 8 weeks~     or placebo. Primary and secondary endpoints will be the number of SBMs/week and colonic~     transit time as measured by the Smartpill capsule, respectively. The number of SBMs/week will~     be evaluated at 0, 2, 4 and 8 weeks after initiation of therapy. The investigators will~     over-sample African American patients to achieve approximately 50% enrollment of this group.~     In a subanalysis, the investigators will assess response to treatment between the general~     population and African Americans.~      We hypothesize that lubiprostone will significantly increase the number of SBMs as well as~     decrease colonic transit time and improve quality of life in constipated diabetic patients~     compared with placebo.~   "
182984|NCT01169675|"~     This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose~     pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW~     2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on days 1~     to 6 of a 21 day cycle.~      The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including~     BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer~     (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single~     agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from~     this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in~     advanced cancer patients in combination therapy with pemetrexed.~   "
182958|NCT01170026|"~     This application will provide a test of one potential model for adding substance use~     assessment and brief intervention into a truancy court program. The primary goal of this~     study is to determine whether a motivational intervention will reduce substance use among~     adolescents referred to truancy court for school attendance problems. In this treatment~     development application, an open trial with 20 families referred by truancy court will first~     be conducted. This trial will be used to adapt an existing motivational intervention to~     include material relevant to school attendance and performance. Then 100 families~     participating in the Rhode Island Truancy Court Program with adolescents between the ages of~     13-16 years who report using substances will be randomly assigned to receive the experimental~     intervention plus standard truancy court procedures or psychoeducation plus standard truancy~     court procedures. The 2-session intervention protocol consists of an individual motivational~     interview plus the Family Check-Up (Dishion & Kavanagh, 2003), a family based motivational~     interview. The experimental protocol provides a thorough assessment of both individual and~     family strengths and weaknesses with respect to substance use prevention and school~     attendance/performance. Follow-up interviews will be conducted at 3 and 6 months.~   "
182959|NCT01170013|"~     The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of~     long-range problems. This association persists despite changes in national substance use~     rates over time, indicating its stability and viability as a target for prevention. At the~     same time, parent monitoring of youth behavior tends to decrease during the adolescent years,~     creating a source of risk for not only the early onset of AOD use but also escalation. Thus,~     programs are needed in parenting behaviors and family relationships that are protective in~     helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly~     true of children with psychiatric disorders who are at higher risk for developing AOD~     disorders than nonpsychiatrically disturbed children. The primary goal of this study is to~     test the effectiveness of a family-centered intervention to reduce the risk of AOD use among~     pre-adolescent children with a history of emotional/behavioral problems. In this application,~     the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been~     referred for mental health care due to psychiatric symptomatology, will be randomly assigned~     to receive either an individually tailored family program or standard care. The experimental~     intervention, which is based on the Family Check-Up model (Dishion & Kavanagh, 2003),~     provides a thorough assessment of family strengths and weaknesses as they relate to future~     risk for AOD use as well as emotional/behavioral problems, and utilizes principles of~     motivational interviewing to encourage families to change. Follow-up interviews will be~     conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and~     other risky behaviors.~   "
182960|NCT01170000|"~     A national priority for health care providers is to initiate early communication about~     palliative and end-of-life care (PC/EOL) for children with a poor prognosis. Communication~     about prognosis and advanced care planning is critical to empowering parents to make~     decisions about PC/EOL for their children. A single-group study to refine and pilot test a~     PC/EOL communication intervention is entitled, Communication Plan: Early through End of Life~     (COMPLETE). COMPLETE is designed to be delivered during parent meetings and features: (a) a~     physician-nurse (MD/RN) team approach to PC/EOL communication; (b) printed visual aids and~     parent resource forms; and (c) hope and non-abandonment messages tailored by a MD/RN team to~     their communication style and parental preferences for information. During Phase I, an~     interdisciplinary approach involving nurses, physicians, PC/EOL expert consultants, and~     bereaved-parent consultants met to develop a standardized protocol and training procedures.~     During Phase II, this protocol will be evaluated with 24 parents and MD/RN teams. The~     investigators will evaluate parental outcomes regarding the COMPLETE's influence on: (a)~     information needs, emotional needs/resources, appraisal of MD/RN information and of symptom~     management; and (b) parental distress, uncertainty, decision regret, hope, satisfaction with~     MD/RN communication, and advance care planning over time. Findings from this study address~     NIH priorities related to: 1) an underserved population (i.e., parents of children with brain~     tumors); 2) an under-examined ethical concern about early integration of PC/EOL communication~     for parents of children with poor prognosis; 3) improved communication about PC/EOL among~     physicians, nurses, and parents; and 4) the potential for changing health care practice.~   "
182961|NCT01169987|"~     This observational study will document to what extent in daily clinical practice Humira~     (adalimumab) therapy is continued, interrupted or permanently discontinued during a follow-up~     period of 2 years. Reasons for interrupting or permanently discontinuing Humira therapy and~     reasons for restarting Humira therapy will be noted. An evaluation will be performed of the~     effect of the disease on quality of life and work productivity.~   "
182962|NCT01169974|"~     The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for~     the measurement of cutaneous blood flow following various durations of tourniquet ischemia.~   "
182963|NCT01169961|"~     The purpose of the present study is to evaluate in hemodialysis patients, who have elevated~     serum ferritin ( >2000ng/ml) and transferrin saturation (TSAT) >30%, iron deposition in the~     heart, pancreas, liver and spleen using the T2* MRI technique.~      In addition, we will also measure the free iron forms in the plasma and LPI, LCI in red blood~     cells, platelets and PMN, in addition to serum hepcidin, TSAT, serum ferritin, CRP and~     oxidative stress parameters (ROS,GSH, and malonyldialdehyde (MDA).~   "
182964|NCT01169948|"~     Recent advances in technology have resulted in the development of scanners that can n image~     the heart arteries within 10 to 20 minutes but without the need for admission to hospital or~     insertion of catheters. This means that coronary heart disease may be more readily identified~     (or ruled out) and allow better diagnosis and treatment of patients with symptoms suggesting~     coronary heart disease. Here, we propose to assess the latest and most powerful scanners to~     see if it can accurately diagnose the extent of coronary artery disease and facilitate the~     planning of heart surgery.~   "
182986|NCT01169649|"~     The purpose of this study is to test a new drug called MK-2206. This study is a phase II~     study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a~     new treatment has against a certain type of cancer.~      MK-2206 is an oral medication known as a targeted therapy. By attaching to the target, we~     hope that MK-2206 may stop the cancer cells from further growth and dividing. This study will~     help find out if MK-2206 is a helpful drug when taken in patients with neuroendocrine tumor.~   "
182965|NCT01169935|"~     Treatment of a wide range of diseases using stem cells and other types of cell appears~     promising. Following administration of cells it is often not clear where exactly the cells~     have gone and how many of them have reached the target site. This has been one of the~     challenges of developing these treatment options further. We have developed a method of~     labelling human cells with a magnetic resonance imaging (MRI) contrast agent which contains~     tiny iron filings. Following intravenous administration it is possible to see where the~     iron-labelled cells have gone using MRI scanning. We would like to do is to demonstrate that~     these cells behave normally and migrate to a site of inflammation. We plan to induce an area~     of inflammation in the forearm of healthy volunteers using the Mantoux test (a test of~     immunity against tuberculosis) before giving the labelled cells intravenously. After the~     Mantoux test we will give these volunteers iron-labelled cells and do MRI scans of their~     forearm to determine whether these cells can be seen accumulating in the target site.~   "
182966|NCT01169922|"~     This research is examining how genetic and brain factors play a role in adolescents' health~     risk behavior as well as studying behaviors that young people engage in that may place them~     at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of~     educational program works best to reduce these risky behaviors.~   "
182967|NCT01169909|"~     Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in~     pterygium, a neovascular disorder of the ocular surface.~   "
182968|NCT01169896|"~     Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF)~     thérapies as a function of ventricular pacing~   "
182969|NCT01169883|"~     Inner-city African American and Hispanic adolescents suffer from disproportionately high~     rates of emergency room visits and hospitalizations for acute exacerbations of asthma. This~     study proposes the use of a coping peer support intervention, enhanced by a technology-based~     platform that infuses peer support throughout adolescents' daily routines, to increase~     adherence to daily controller medications and ultimately reduce asthma exacerbation risk in~     this important population subgroup.~   "
182970|NCT01169870|"~     The purpose of this study is to evaluate the overall response rate of Genexol-PM compared~     with paclitaxel (cremophor-based paclitaxel) as palliative chemotherapy in~     anthracycline-pretreated patients with metastatic breast cancer.~   "
182971|NCT01169857|"~     The primary objective is to test the safety and efficacy of Velcade to induce remission in~     WHO class III/IV/V lupus nephritis that are refractory to standard medications.~   "
182972|NCT01169844|"~     This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in~     patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for~     patients in the core trial, to obtain safety and tolerability information. The study will~     address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks over~     a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in~     psoriatic arthritis a decision will be made as to whether or not to continue dosing for~     another 6 month period (Part 2).~   "
182973|NCT01169831|"~     Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which are~     important for maintaining cardiovascular health. The prevalence of cardiovascular disease in~     older adults is associated with reduced circulating EPC numbers. Studies have shown reduced~     EPC number and function in old vs. young individuals, and endurance exercise training~     increases EPC number and function in young adults. Oxidative stress adversely affects~     endothelial cells and preliminary evidence indicates that oxidative stress negatively affects~     EPC function. Conversely, regular exercise reduces markers of oxidative stress and may~     enhance EPC function in older adults. The investigators hypothesize that older~     endurance-trained athletes and matched sedentary individuals will have markedly divergent EPC~     function and that altering the physical activity levels of both groups will move them to~     intermediate points between these two extremes. The investigators also propose that the~     investigators can mimic the effect of exercise training on EPC function in cell culture by~     altering intracellular levels of a key enzyme and a signaling molecule which the~     investigators have shown to regulate EPC function with respect to exercise training in young~     individuals.~   "
182974|NCT01169818|"~     Primary Objective:~      To compare patient-led titration (intervention group) versus physician-led titration (usual~     standard of care) in optimizing the clinical use of insulin glargine in an Asian population~     of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs~     (OADs).~      Secondary Objectives:~      To determine the difference in glycemic control, safety, quality of life and treatment~     satisfaction between patient-led titration and usual care.~   "
182975|NCT01169805|"~     The aim of this prospective randomized controlled study was to compare the prophylactic~     effects of intravenous single dose of ondansetron, ramosetron, and palonosetron on~     PCA-related nausea and vomiting after urologic laparoscopic surgery.~   "
182976|NCT01169792|"~     The genetic polymorphisms of the cytochrome P450 may influence on the metabolism of~     tamoxifen.~      The investigators want to~        -  evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450~          subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and~        -  analyze the association between the genetic polymorphisms of cytochrome P450 subfamilies~          and clinical outcomes in breast cancer patients treated by adjuvant tamoxifen therapy.~   "
182977|NCT01169779|"~     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010) in~     comparison to placebo, as an add-on treatment to metformin with or without sulfonylurea, over~     a period of 24 weeks of treatment.~      The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010)~     in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in~     terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.~      The secondary objectives are to assess the effects of lixisenatide over 24 weeks on~     percentage of patients reaching HbA1c less than (< ) 7 percent (%) or HbA1c less than or~     equal to (<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG)~     and glucose excursion during standardized meal test, body weight; to evaluate safety,~     tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.~   "
182978|NCT01169753|"~     The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to~     control fatigue in patients with CML. The safety of this drug will also be studied.~   "
182987|NCT01169636|"~     Objectives:~      Primary objective:~        -  Phase-I: To determine the maximal tolerated dose (MTD) of panobinostat (LBH589) +~          Ifosfamide + Mesna, Carboplatin and Etoposide (ICE) combination~        -  Randomized Phase-II: To estimate the complete response (CR) rate in patients with~          relapsed and refractory classical Hodgkins Lymphoma (HL) receiving ICE versus~          PANOBINOSTAT plus ICE therapy~      Secondary Objectives:~        -  To assess the safety and tolerability of the novel combination of PANOBINOSTAT (LBH589)~          plus ICE versus ICE in patients with relapsed and refractory HL~        -  To estimate the overall response rate (CR + partial response PR)~        -  To estimate the success rate of stem cell collection in patients eligible for stem cell~          transplant~        -  To estimate the percentage of patients who subsequently undergo autologous stem cell~          transplantation (ASCT)~        -  To estimate the event free survival (EFS) at 1 year after randomization~        -  To determine pretreatment expression level of histone deacetylases (HDAC1), HDAC2, and~          pSTAT3 and Signal transducer and activator of transcription protein (pSTAT6) by~          Immunohistochemistry (IHC) and correlate the results with treatment response~   "
182988|NCT01169623|"~     Hypothesis Applying Educational Intervention Based On Supportive behaviour Leadership Model~     has positive effect on Head Nurses' performance in TUMS Hospitals.~      Specific objectives~        1. Assessing the impact of supportive leadership behaviour on individual head nurse~        2. Assessing the impact of supportive leadership behaviour on nursing team~        3. Assessing the impact of supportive leadership behaviour on TUMS organizational success,~          especially in cross-functional environments~        4. Develop a specific plan for effectively supportive leadership behaviour the efforts of~          others to sustain and encourage productive performance and employee satisfaction~   "
182989|NCT01169610|"~     The overall hypothesis of this line of research is that varenicline will decrease alcohol~     consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order~     to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open~     label pilot study investigating the effect of varenicline on reduction of and abstinence from~     alcohol and tobacco; and 2) an optional MR spectroscopy to investigate whether glutamate and~     other brain metabolites correlate to measures of alcohol craving severity and/or subsequent~     varenicline treatment response.~   "
182990|NCT01169597|"~     Polymyalgia rheumatica (PMR) is a common inflammatory condition affecting elderly people and~     involving the girdles. The mainstay of treatment is oral glucocorticoids (GC), with the~     recent BSR-BHPR guidelines suggesting an initial prednisone dose comprised between 15 and 20~     mg as appropriate. However, probably because of the dramatic response of PMR to GC,~     randomized controlled trials of treatment are lacking. As a result, there is no evidence from~     controlled studies on the efficacy of different initial doses or drug tapering. Objective of~     the study: to test if 12.5 mg prednisone/day is an adequate starting dose in polymyalgia~     rheumatica (PMR) and to evaluate clinical predictors of drug response.~      Methods: 60 consecutive PMR patients will be treated with a starting dose of 12,5 mg/day~     prednisone. Clinical, laboratory, and ultrasonographic features will be recorded as possible~     predictors of response to prednisone. Remission is defined as disappearance of at least 75%~     of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, a~     scenario allowing steroid tapering.~   "
182991|NCT01169584|"~     This is a Phase I, open-label, dose-escalation trial of JX-594 (Pexa-Vec) in pediatric~     patients with advanced/metastatic, unresectable solid tumors refractory to standard therapy~     and/or the patient does not tolerate standard therapies. Tumors are likely to include~     neuroblastoma, lymphoma, Wilms' tumor, rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma,~     non-rhabdomyosarcoma soft tissue sarcomas, and malignant peripheral nerve sheath tumors.~     Benign tumors are excluded. These tumor types were selected because evidence of biological~     activity was observed in cancer cells lines and ex vivo infected primary human tissue~     samples, specifically pediatric cancer types such as sarcomas and neuroblastomas.~   "
182992|NCT01169571|"~     The objective of this study is to characterize the hemodynamic effects of Precedex~     (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated~     post-surgical subjects in an intensive care setting.~   "
182993|NCT01169558|"~     This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5~     mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based~     chemotherapy as first line treatment in participants with metastatic cancer of the colon or~     rectum. The anticipated time on study treatment is 3-12 months.~   "
182994|NCT01169545|"~     The primary purpose of this study is to examine how vulnerabilities in psychological and~     social situations affect financial quality of life.~   "
182995|NCT01169532|"~     This phase I trial is studying the side effects and best dose of giving ridaforolimus and~     vorinostat together in treating patients with advanced solid tumors or lymphoma. Giving~     ridaforolimus in combination with vorinostat may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~   "
182996|NCT01169519|"~     Patients with single ventricle anatomy undergo staged surgical palliation. The result is an~     in series circulation with pulmonary blood flow and cardiac output directly related to~     pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the~     single ventricle palliation results in continued long term attrition. Elevated pulmonary~     vascular resistance and impaired systemic ventricular function are important risk factors for~     failure of single ventricle palliation.~      Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in~     the pressure overloaded right ventricle.~      The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of~     sildenafil in single ventricle patients following stage II and III surgical palliation.~   "
182997|NCT01169506|"~     Sublingual positioning of a silicon capillary system is applied. After 15 min, while the~     individual is in resting position with closed mouth and normal tidal breathing through the~     nose is performed, the silicon capillary system is connected to a capnometer and CO2 tension~     is measured.~      The investigators hypothesis is that this setup offers a non-invasive assessment of~     ventilatory efficiency with similar accuracy as arterial PCO2.~   "
183008|NCT01169363|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the~     laboratory may help doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from~     older patients with acute myeloid leukemia treated with cytarabine-based therapy.~   "
182998|NCT01169493|"~     Heart failure (HF) affects 5 million Americans and is responsible for more health-care~     expenditure than any other medical diagnosis. Approximately half of all HF patients have~     electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a~     perturbation of the normal pattern of ventricular contraction that reduces the efficiency of~     ventricular work. Ventricular dyssynchrony is directly responsible for worsening HF~     symptomatology in this subset of patients. Resynchronization of ventricular contraction is~     usually achieved through simultaneous pacing of the left and right ventricles using a~     biventricular (BiV) pacemaker or implantable cardioverter-defibrillator. Clinical trial~     evidence supporting the use of BiV pacing in patients with prolonged QRS duration was~     obtained almost exclusively in patients with a left bundle-branch block (LBBB)~     electrocardiographic pattern. Recent evidence suggests that resynchronization of ventricular~     contraction in patients with LBBB can be obtained by univentricular left ventricular pacing~     with equal or superior clinical benefits compared to BiV pacing. Animal studies suggest that~     ventricular resynchronization can be obtained in subjects with right bundle-branch block~     (RBBB) through univentricular right ventricular pacing. No clinical trial evidence exists to~     support the use of BiV pacing in patients with RBBB. Thousands of patients with symptomatic~     HF and RBBB currently have univentricular ICDs in place for the prevention of sudden cardiac~     death. Most of these devices are currently programmed to avoid RV pacing. We aim to determine~     if ventricular resynchronization delivered through univentricular RV pacing improves symptoms~     in patients with RBBB and moderate to severe HF who have previously undergone BiV ICD~     implantation for symptomatic heart failure. We further aim to determine if ventricular~     resynchronization improves myocardial performance and ventricular geometry as detected by~     echocardiographic measures and quality of life for patients with HF and RBBB. We hypothesize~     that RV univentricular pacing delivered with an atrio-ventricular interval that maximizes~     ventricular synchrony is equivalent to BiV pacing for improvement in cardiac performance, HF~     symptoms, and positive ventricular remodeling in patients with HF and RBBB.~   "
182999|NCT01169480|"~     The aim of this study is to investigate if giving a massage impacts the mental state of a~     massage therapist, including depression, anxiety, and stress . It is speculated that feelings~     of depression, anxiety and stress will reduce following the giving of a massage.~   "
183000|NCT01169467|"~     The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in~     addition to the current standard-of-care for sedation.~   "
183001|NCT01169454|"~     The purpose of this study is to explore two currently accepted methods of intracranial~     pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed~     with subarachnoid hemorrhage (SAH). This is a randomized observational study of two~     physician-prescribed approaches to managing ICP monitoring and CSF drainage for SAH patients.~     The study will enroll only those patients who have ICP monitoring. Because this is an~     observational study, there are no physical risks to the patient, the only risk is loss of~     confidentiality.~   "
183002|NCT01169441|"~     The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has~     changed the population of patients being implanted. Younger and healthier patients are now~     being implanted for primary prevention of sudden cardiac death. Due to the younger~     population, the likelihood of the lead failing during the lifetime of the patient is higher~     and also more likely to need extraction. To reduce the risk of the lead extraction procedure~     and therefore reduce the number of abandon leads, ICD lead manufacturers are designing leads~     to offer improved chronic extractability to reduce the morbidity and mortality during these~     procedures.~   "
183003|NCT01169428|"~     The purpose of this study is to determine whether a 12 week Mindfulness-Based Weight Loss~     Maintenance (MBWLM) intervention is effective in maintaining recent loss of 10% or more of~     initial body weight.~   "
183004|NCT01169415|"~     Purpose and Objective:~        1. To compare the effects of either an abbreviated or protracted taper of dexamethasone on~          functional capacity in newly diagnosed glioblastoma multiforme (GBM) patients.~        2. To compare neurocognitive function in newly diagnosed GBM patients receiving either an~          abbreviated or protracted taper of dexamethasone.~        3. To compare skeletal muscle strength in newly diagnosed GBM patients receiving either an~          abbreviated or protracted taper of dexamethasone.~        4. To examine the association between functional capacity and neurocognitive function and~          patient-reported measures (i.e. quality of life, fatigue, etc.) in newly diagnosed GBM~          patient on either an abbreviated or protracted taper of dexamethasone.~        5. To examine the association between functional capacity and neurocognitive function and~          body composition measures (body-mass index, etc.) in newly diagnosed GBM patient on~          either an abbreviated or protracted taper of dexamethasone.~        6. To examine the association between functional capacity and neurocognitive function and~          biochemical metabolic measurements in newly diagnosed GBM patient on either an~          abbreviated or protracted taper of dexamethasone.~      All study endpoints will be assessed at three timepoints as follows: (1) initial assessment~     after surgery in the hospital, (2) second assessment at initial clinical visit at the Preston~     Robert Tisch Brain Tumor Center (PRT-BTC) at Duke, approximately 1 week post-operatively, and~     (3) third assessment at second clinical visit in the PRT-BTC at Duke, approximately 10 weeks~     post-operatively and after completion of radiotherapy. An additional fourth assessment will~     be obtained at 4 weeks post-operatively if the subject is undergoing radiotherapy here at~     Duke.~   "
183005|NCT01169402|"~     Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support~     children who suffer heart or lung failure until whatever illness caused that failure can be~     treated and reversed. While on ECMO, children are at increased risk of infection, including~     fungal infection. Treatment for fungal infection includes not only antifungal medications but~     also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper~     treatment of fungal infections would be difficult if not impossible. The investigators~     believe that giving prophylactic antifungal medication to all children on ECMO may prevent~     fungal infections from developing in the first place.~      Fluconazole is an antifungal medication that works well against the most common fungal~     infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the~     potential to significantly alter the drug levels of medications so the investigators do not~     know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole~     is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data~     and modeling from other studies, the investigators think 25mg per kilogram given once weekly~     will achieve proper drug levels to prevent fungal infections. The investigators have obtained~     FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the~     study. Blood samples will be collected at specific times around the first and second~     fluconazole doses to describe the PK and drug extraction by the ECMO circuit.~   "
183006|NCT01169389|"~     This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a~     hyaluronic acid supplement) administered immediately following the completion of knee~     arthroscopy.~   "
183007|NCT01169376|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in young patients with neuroblastoma.~   "
183009|NCT01169350|"~     This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans~     to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue~     sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic~     procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to~     find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors~     predict how well a patient will respond to treatment.~   "
183010|NCT01169337|"~     This randomized phase II/III trial studies how well lenalidomide works and compares it to~     observation in treating patients with asymptomatic high-risk asymptomatic (smoldering)~     multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system~     in different ways and stop cancer cells from growing. Sometimes the cancer may not need~     treatment until it progresses. In this case, observation may be sufficient. It is not yet~     known whether lenalidomide is effective in treating patients with high-risk smoldering~     multiple myeloma than observation alone.~   "
183011|NCT01169324|"~     The purpose of this prospective, participant-blinded trial is to determine the changes in~     sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS)~     surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease~     (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral~     subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after~     the procedure. The cause of this improvement in sleep quality is unknown, and this study~     proposes the use of polysomnography (PSG) to test whether the improvement in sleep is~     independent of improvement in night-time mobility associated with DBS treatment of the motor~     symptoms of PD, tremor, or dystonia.~   "
183012|NCT01169311|"~     Trial Objectives~      The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid~     and Prolapse Stapling Set:~      overall performance defined by the successful creation of a normal staple line safety as~     measured by the 30 day incidence of adverse events.~   "
183013|NCT01169298|"~     To determine the maximum tolerated dose of lenalidomide in patients with adult T-cell~     leukemia-lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) who have previously received~     therapy for ATL and PTCL~   "
183014|NCT01169285|"~     The purpose of the study is to test the efficiency and efficacy of the Distress Thermometer~     of patients admitted to the tertiary Burn and Wound Center. The American Cancer Society and~     the National Comprehensive Cancer Network published treatment guidelines in 2005 adopting the~     use of the Distress Thermometer as the preferred adjunct assessment tool of a patient's~     emotional well-being. A literature search provided extension of the tool to a Cardiac~     Follow-up Clinic. The Distress Thermometer is currently used with oncology patients at Saint~     Elizabeth.~      The emotional well being of patients and their significant others is a hallmark of wholistic~     care. The simple Likert scale of 0-10 has a trigger for further assessment and/ or~     intervention at four. The validity testing of the tool was done against the Hospital Anxiety~     and Depression Scale (HADS) and the Brief Symptom Inventory (BSI-18).~      The purpose of this study is to measure the efficiency and efficacy of the documentation of~     the Distress Thermometer to patients admitted to a tertiary Burn and Wound Care Center. The~     frequency of the documentation will be counted and type of documentation will be categorized.~   "
183015|NCT01169272|"~     Sorin Group has developed a new atrial lead which is under evaluation during this study. The~     SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature;~     interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization.~      The new RV autothreshold algorithm has been implemented in the CRT-ICD and will help the~     physician in his diagnosis avoiding potential lost of capture.~      The ICD device has also the capability to be remotely interrogated through the remote~     monitoring system whose performances will be reported during the study.~      Finally, the study will report the electrical and handling performances of the new left~     ventricular lead.~   "
183016|NCT01169259|"~     The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial in 25,871~     U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000~     IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer,~     heart disease, and stroke in people who do not have a prior history of these illnesses.~   "
183017|NCT01169246|"~     Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple,~     dual or triple chamber ICD.~   "
183018|NCT01169233|"~     The success of human expedition missions critically depend on the ability of the crew to be~     alert and maintain high levels of cognitive function while operating complex, technical~     equipment. Optimal human health, performance and safety during space flight requires~     sufficient sleep and synchrony between the circadian pacemaker—which regulates the timing of~     sleep, endocrine function, alertness and performance—and the timing of the imposed sleep-wake~     schedule.~      Crewmembers of the 105-day simulation study will be required to work one night shift every~     sixth night. This schedule will likely result in sleep loss and circadian misalignment,~     especially when lighting conditions are similar to those that crewmembers experience during~     spaceflight. External mission controllers will work 24-hour shifts, also resulting in both~     sleep loss and circadian misalignment.~      It has been well documented in laboratory and field studies that both working the night shift~     and working extended duration shifts result in decrement alertness, performance and mood. In~     addition to the negative effects that night shift work has on alertness, performance and~     mood, shift work causes significant short and long-term health problems. Shift workers,~     particularly night shift workers who invert their normal sleep/wake schedule, suffer for~     several reasons. First, their endogenous circadian rhythms and the imposed sleep/work~     schedule are typically out of phase. This is similar to the experience of jet lag. However,~     while environment cues (e.g., sunrise, sunset, the timing of meals and sleep) enable~     travelers to adapt quickly to a new time zone, crewmembers in the 105-day simulation will be~     unable to do so because they will only spend one night of every five working. When working~     the night shift, the timing of meals, work, and sleep will therefore be out of phase with the~     normal entrained phase of the circadian timing system. Ingestion of meals at an inappropriate~     circadian phase results in impaired metabolism, likely underlying the gastrointestinal and~     metabolic problems experienced by shift workers. Second, this circadian misalignment leads to~     a substantial loss of sleep efficiency during the (daytime) sleep period, independent of, and~     in addition to, environmental obstacles to sleep (e.g., noise, light, other crewmembers).~     Third, misalignment of circadian phase coupled with sleep loss will each result in~     deterioration of alertness and impairment of performance during the night. Since these~     adverse effects are particularly acute on the first night of work, the plan for crewmembers~     on the Mars 105 mission to work the midnight shift every sixth night will subject them~     repeatedly to the performance impairments associated with acute circadian misalignment and~     acute sleep deprivation.~      Lighting Countermeasure. Our group at the Harvard Medical School has successfully developed~     and tested effective photic countermeasures to alleviate circadian misalignment and improve~     alertness, performance and mood in night shift workers. The most effective countermeasure to~     circadian alignment is appropriately-timed and sufficiently intense light. Light also acutely~     improves alertness, performance and mood. Most recently it has been reported that short~     wavelength light has been shown to be most effective for both resetting circadian rhythms and~     acutely improving performance during night work via antecedent suppression of the soporific~     hormone melatonin.~      These photic countermeasures have been tested in individual subjects living in laboratory~     simulations (Countermeasures readiness level/Technology readiness level 7; Evaluation with~     human subjects in controlled laboratory simulating operational spaceflight environment). The~     next critical step is to evaluate our countermeasures in an operational simulation of space~     flight that includes study of the interaction among crew members in a high fidelity~     simulation (Countermeasures readiness level/Technology readiness level 8; Validation with~     human subjects in actual operational spaceflight to demonstrate efficacy and operational~     feasibility).~      Adequate sleep and circadian alignment are critical to maintaining the health and performance~     of expedition mission crewmembers. Testing of the developed lighting countermeasure in a high~     fidelity operational environment imitating the conditions of a future expedition mission~     (e.g., to Mars) is critical to ensure countermeasure readiness and to reduce the risk of~     human performance errors due to factors related to circadian disruption, sleep loss and~     fatigue. Development and testing of this photic countermeasure for mission controllers~     working 24-hour shifts will further ensure the success of the future long duration expedition~     missions.~   "
183019|NCT01169220|"~     This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy:~     the entire preparation taken the night before the procedure versus half the preparation taken~     the night before the procedure, and the other half taken the morning of the procedure.~   "
183020|NCT01169207|"~     Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC),~     is a idiopathic, chronic and frequently disabling inflammatory disorder of the intestines~     characterized by a dysregulated mucosal immune response that affect more than a million~     Americans. This current protocol was established in 1996 with the goal of identifying the~     genetic and environmental components that contribute to the development of IBD, especially in~     families.~   "
183021|NCT01169194|"~     The investigators are doing the research to discover genes that cause Inflammatory Bowel~     Disease (IBD) specifically in the African American population. African Americans with or~     without Crohn's disease or ulcerative colitis are eligible to join. If you agree to join the~     study, the investigators will ask for information about your health. The investigators will~     also ask you to give us a blood sample so that they may discover the genes that cause IBD.~     The blood sample may be collected at Johns Hopkins or any local facility convenient to you.~   "
183022|NCT01169181|"~     The procedure involves: (1) assisted hand movement by a mechanical device, (2) mechanical~     vibration applied to the surface of the forearm, and (3) stimulation of the brain with either~     transcranial magnetic stimulation (TMS) or transcortical direct current stimulation (DCS).~     These 3 components of the procedure are carried out simultaneously. Each subject will be~     evaluated pre- and post-treatment with several clinical tests of functional movement. The~     hypotheses of this project are that the AMES+rTMS and AMES+tDCS procedures are safe and will~     enable most of the stroke patients to recover finger extension.~   "
183067|NCT01168596|"~     The purpose of the research study is to determine if rasagiline is an effective treatment for~     fatigue in patients with Parkinson's disease (PD).~   "
183023|NCT01169168|"~     In this study patients with~        1. chronicle liver diseases~             -  primary biliary cirrhosis~             -  primary sclerosing cholangitis~             -  alcoholic liver cirrhosis~             -  hepatitis b or C~             -  Wilson's disease~             -  cryptogenic cirrhosis~        2. Septic Inflammatory Response Syndrome (SIRS)~             -  sepsis~             -  septic shock~        3. patients after lysis~      should be included~      Blood samples will be gathered from the patients to measure fibrinogen with 5 different~     methods.~      The methods are:~        -  Clauss fibrinogen~        -  PT-Derived fibrinogen~        -  immunoturbidimetric method~        -  heat-precipitated fibrinogen~        -  Schulz fibrinogen~      The result of these tests will be correlated with laboratory values which are gathered in~     routine and the clinical outcomes.~   "
183024|NCT01169155|"~     Specific Aim 1 is to test the hypothesis that there are specific characteristics of a voice~     smoke alarm (i.e., use of child's first name, behavior commands in the message content, use~     of mother's voice, and stimulus frequency) that will awaken children 5-12 years old in stage~     4 sleep. The successful children's alarm will be tested among adult subjects to evaluate~     effectiveness across the age spectrum.~      Specific Aim 2 is to test the hypothesis that there are specific characteristics of a voice~     smoke alarm (i.e., use of mother's voice and behavior commands in the message content) that~     will result in successful completion of simulated escape behaviors by children 5-12 years old~     after awakening from stage 4 sleep. The successful children's alarm will be tested among~     adult subjects to evaluate effectiveness across the age spectrum.~   "
183025|NCT01169142|"~     Supplementation of Vitamin D in those with low levels will increase the level and result in~     some improvement in health and psychopathology measures.~   "
183026|NCT01169129|"~     Patients in good general condition with resectable brain metastases, looks better with more~     intense treatment of metastases. This local treatment has been accomplished with surgery or~     radiosurgery. However, there are no randomized studies comparing these two types of~     treatment. The purpose of this study is to make this.~   "
183027|NCT01169116|"~     Patients with single brain metastasis without other metastatic site have a better prognosis,~     and they need a better brain metastasis control. For non-resectable and non-radiosurgical~     brain metastasis, the gold standard treatment is whole-brain irradiation with 30 Gy in 10~     fractions, but the local control is not achieved in most of the cases. This study investigate~     the possibility to increase radiation dose in this metastasis with exclusive hypofractionated~     stereotactic radiotherapy.~   "
183028|NCT01169103|"~     Teenagers and adults who are overweight or obese have an increase in fat in the abdomen,~     which increases their risk for diabetes and heart disease. Reducing abdominal fat is~     important to reduce risk for diabetes and for heart disease. Overweight teenagers also have~     low levels of growth hormone compared to normal weight teenagers, and teenagers with the~     lowest growth hormone levels also have the greatest abdominal fat. In children who are unable~     to make growth hormone for other reasons, giving back growth hormone leads to a decrease in~     abdominal fat. We are studying whether giving growth hormone in small doses to overweight~     teenagers can change body composition. We hypothesize that growth hormone will cause~     abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.~   "
183029|NCT01169090|"~     The purpose of this study is to evaluate the safety and efficacy of a range of doses of~     SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin~     alone.~   "
183030|NCT01169077|"~     Malaria, a disease responsible for over one million deaths per year, is caused by a germ~     spread by mosquito bites. The purpose of this study is to evaluate a vaccine designed for the~     prevention of malaria caused by the parasite, Plasmodium falciparum, and to evaluate the~     device used to give the vaccine. This study will provide information on how safe, effective,~     and tolerable the vaccine is in healthy adults. The participants will be assigned, by chance,~     to receive 3 doses/shots of the vaccine or a placebo (substance that contains no medication)~     by injection in the upper arm. Study participants will include 39 healthy adults aged 18-40~     years who have not been exposed to malaria and who will enroll at the Emory Vaccine and~     Treatment Evaluation Unit in Atlanta, Georgia. Study procedures include physical exams and~     several blood samples. Participants will be involved in the study for approximately seven and~     one half months.~   "
183031|NCT01169064|"~     A common concern in any surgical procedure is the occurrence of infection. Silver-containing~     treatments are popular and used in wound treatment; however, there is presently little~     evidence of the effectiveness of silver-containing treatment for the prevention of~     obstetrical wound infection. We plan to investigate the rate of infection in women~     experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing~     the infection rate based on a randomized choice of silver-containing wound dressings to soft~     cloth adhesive wound dressings.~   "
183032|NCT01169051|"~     There is data to support an association between impaired preoperative endothelial function~     and adverse postoperative outcome. This study will investigate the potential association~     between perioperative statin use and improved perioperative and long-term cancer outcome~     amongst thoracic surgery patients undergoing lung or esophageal resection.~   "
183033|NCT01169038|"~     Sarcoidosis is a granulomatous disease for which the molecular and immunologic association~     with mycobacteria continues to strengthen. The investigators are interested in conducting a~     proof-of-concept investigation of the effects of antibiotics on sarcoidosis resolution. The~     investigators hypothesize that pulmonary sarcoidosis will improve faster if patients are~     given antimycobacterial therapy, in addition to their standard therapy.~   "
183034|NCT01169025|"~     Often, patients transported by aeromedical systems do not receive enough medication to~     control and relieve their pain. The purpose of this study is to determine if pain treatment~     with intravenous (IV) ketamine is a better way to treat aeromedical patients' pain than the~     current treatment practices.~   "
183035|NCT01169012|"~     This is a non-blinded, non-randomized pharmacokinetic study to determine the oral~     bioavailability of clofarabine, and the effect of cimetidine on clofarabine pharmacokinetics~     in patients with poor-risk acute leukemias and myelodysplastic syndrome (MDS).~   "
183315|NCT01165359|"~     Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is~     being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine~     different doses of the medication to evaluate which dose is the most effective at lowering~     the amount of HCV in the blood.~   "
183036|NCT01168999|"~     The purpose of this study is to determine whether a novel placebo for comparison to spinal~     manipulation is believable and creates similar expectation for treatment effectiveness as the~     studied spinal manipulation technique. Additionally, we wish to compare outcomes related to~     low back pain, function, and pain sensitivity between people receiving the placebo, spinal~     manipulation, and no therapy.~   "
183037|NCT01168986|"~     This study is comparing the effectiveness of a mechanical manual therapy device to a specific~     exercise to no treatment in individuals experiencing neck pain. We are interested in the~     effects of the interventions on neck pain, disability related to neck pain, and pain~     sensitivity.~   "
183038|NCT01168973|"~     The purpose of the study is to compare the survival of participants who receive chemotherapy~     and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior~     first line platinum-based chemotherapy.~   "
183039|NCT01168960|"~     Cognitive-behavioral therapy (CBT) is an effective treatment for alcohol dependence, but~     little is known about how CBT works to achieve these effects. Although several possible~     mechanisms have been proposed to explain the effects of CBT, it is rare that more than one~     mechanism is studied. However, it may be the case that similar outcomes (e.g., abstinence)~     may be reached through multiple paths. Therefore, essential to conducting work on behavioral~     change mechanisms is distinguishing different courses or paths and moderating influences~     (Kazdin, 2007). In the present study, we will focus on 2 key mechanisms posited to underlie~     the effectiveness of CBT specifically, increasing self-efficacy and self-confidence and~     reducing positive outcome expectancies for alcohol use, and 2 key mechanisms posited to~     underlie the effectiveness of a wide range of therapeutic interventions, increasing the~     therapeutic alliance and reducing/regulating negative emotional states. For the present~     study, participants will be 72 alcohol dependent men and women who agree to participate in a~     12-week trial of CBT for alcohol dependence. In addition, comprehensive research assessments~     will be conducted with patients at baseline, end of treatment, and 3-months posttreatment.~      Specific Aim 1. To examine the within-treatment week-to-week relationship between ratings of~     4 key therapeutic mechanisms and alcohol involvement (operationalized as percent days~     abstinent {PDA} and drinks per drinking day {DDD}) during treatment. It is hypothesized that~     self-efficacy, outcome expectancies, therapeutic alliance (as rated by the patient and~     therapist), and negative affect assessed after any given treatment session will each predict~     alcohol involvement during the following week. Exploratory analyses also will investigate the~     relationship of a given week's alcohol involvement on each of the four key variables as~     assessed the following week.~      Specific Aim 2. To examine profiles of the four key mechanisms over the course of treatment~     in relation to alcohol involvement during treatment and during the 3-month follow-up period.~     These analyses will be descriptive/exploratory. It is expected that profiles will emerge with~     the key mechanisms that are associated with decreased alcohol involvement (for example, when~     the alliance is relatively strong throughout treatment or when the alliance grows stronger~     over the course of treatment, or when positive outcome expectancies grow weaker over the~     course of treatment, etc.). Similarly, it is hypothesized that profiles will emerge that are~     associated with little improvement in alcohol involvement (for example, when negative affect~     is relatively high throughout treatment or when self-efficacy weakens over the course of~     treatment).~   "
183040|NCT01168947|"~     Sodium loading during hemodialysis treatment is common and may contribute to increased~     interdialytic weight gain and hypertension. Excessive use of isotonic saline (containing 0.9%~     sodium chloride) is one of the factors that may cause sodium loading. During each~     hemodialysis session, approximately 400 mL of isotonic saline fluid, representing 1.4 grams~     of sodium, is used to prime and rinse the extracorporeal circuit, and is often administered~     to the patient. Switching to a non sodium-containing priming and rinsing fluid could allow~     for removal of the equivalent amount of sodium.~      Switching to a non sodium-containing solution for the priming and rinsing of the~     extracorporeal circuit can contribute to increased sodium removal during the dialysis~     treatment and allow for reduced interdialytic weight gain, reduced thirst, and improved blood~     pressure control.~   "
183041|NCT01168934|"~     This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over~     single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV~     formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain at~     least 12 evaluable subjects who complete the study. Each subject will receive two treatments~     (A and B) with a washout period of at least 14 days between each treatment.~   "
183042|NCT01168921|"~     The goal of this clinical research study is to learn if eltrombopag can help to increase the~     number of platelets in patients with CLL. The safety of this drug will also be studied.~   "
183043|NCT01168908|"~     This study, supported by Charley's Fund, Inc., is being done to determine if the drug~     Revatio®(also known as Sildenafil), as compared to placebo (an inactive substance that looks~     like the study drug, but contains no medication), improves heart function in people with~     Duchenne Muscular Dystrophy and Becker Muscular Dystrophy (DBMD).~      In people with DBMD, dystrophin is not present or lacking in heart and muscle. This is~     associated with abnormalities in an enzyme called neuronal nitric oxide synthase or nNOS,~     and leads to decreases in cyclic GMP, which is necessary for proper function of those~     muscles. Revatio blocks an enzyme called phosphodiesterase 5 (PDE5), and helps to restore the~     normal amounts of cyclic GMP. The purpose of this research is to determine if Revatio is safe~     for people with DBMD and if it can improve heart function.~      Hypothesis : PDE5 inhibition, with the use of Revatio, will improve cardiac function in~     patients with DBMD.~   "
183044|NCT01168895|"~     The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin~     after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75~     mg dose will be administered for the first time using a new high dose strength (i.e. one~     capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations~     will focus on local tolerability in the lung and evaluate whether the patient can inhale the~     higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how~     the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this~     study will be used to decide whether the new dose strength is suitable for larger clinical~     trials planned for the COPD patients population.~   "
183045|NCT01168882|"~     The purpose of the study is to determine the safety and tolerability of RGB-286638, a novel,~     multi-targeted kinase inhibitor, administered to patients with selected, relapsed or~     refractory hematological malignancies.~   "
183046|NCT01168869|"~     Some myocardial infarctions (MI) occur as the first manifestation of coronary artery disease.~     These are termed 'unheralded' events as they have not been preceded by other forms of~     coronary artery disease. Unheralded MIs are important because of the high likelihood of~     missed opportunities for prevention. The proportion of MIs that are 'unheralded' is unknown.~      This study aims to quantify the proportion of MIs that occur 'unheralded' and also give an~     estimate of the incidence of 'unheralded' MI in the UK, compared to 'heralded' MI and those~     with angina of recent onset (MIs with premonitory symptoms).~   "
183047|NCT01168856|"~     This observational long-term follow-up study will assess the persistence of direct acting~     antiviral (DAA) resistant mutations and the durability of sustained virological response in~     patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up~     to 5 scheduled monitoring visits for blood sampling during an observational period of up to~     36 months.~   "
183048|NCT01168843|"~     Computer Program for Evaluation of the Symmetry between the Primary Sulci of the Two Fetal~     Brain Hemispheres Using 3-dimensional Ultrasound Planes~      This retrospective study is based on the computerized analysis of the orthogonal fetal brain~     planes.~      The images are obtained from the digital archive of the fetal sonographic examinations done~     in Bnai Zion Medical Center.~      In addition, midsagittal measurements of fetal head will be obtained from this archive of~     3-dimensional images.~      Study measurements will provide the quantitative parameters of normal fetal brain sulcation.~     Normal fetal head growth in midsagittal plane will be studied also.~   "
183049|NCT01168830|"~     First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety~   "
183050|NCT01168817|"~     This study examines the efficacy and safety of the combination treatment BAY60-4552 plus~     vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy~     with PDE5 (Phosphodiesterase 5) inhibitors.~      Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of~     the study to assess the effect of PDE5 inhibitor therapy given alone.~      Patients with an insufficient therapeutic response to vardenafil alone will enter the next~     part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3~     chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone,~     or placebo. Neither patient nor the treating physician will know which treatment is given~     (double-blinded design).This part of the study will last four weeks Patients will have to go~     to the clinic/hospital for 7 visits during the 8 weeks.~   "
183051|NCT01168804|"~     The purpose of this study is to evaluate efficacy and safety of the combination regimen of~     bortezomib-bendamustine-dexamethasone in patients with relapsed or refractory multiple~     myeloma~   "
183052|NCT01168791|"~     This is an international, randomized, double-blind, placebo-controlled trial to evaluate the~     clinical efficacy of palifosfamide-tris administered with doxorubicin in combination,~     compared with doxorubicin administered with placebo in front-line patients diagnosed with~     metastatic soft tissue sarcoma (STS).~   "
183053|NCT01168778|"~     The excessive use of outpatient antibiotics in the pediatric population has contributed to~     the rapid development of resistance in many strains of Streptococcus pneumoniae. Research has~     shown that community-based interventions may have a modest impact on reducing the injudicious~     use of antibiotics in children. However, since the actual prescribing of antibiotics is done~     by physicians and research has shown that physician-parent communication patterns during~     pediatric visits for acute respiratory tract infections (ARTI) strongly influence antibiotic~     prescription rate, it is crucial to develop effective interventions aimed specifically at~     them.~      The overall goal of this study is to improve physician-parent communication patterns during~     visits for pediatric ARTI and, ultimately, to decrease rates of antibiotic prescribing for~     these illnesses in children.~   "
183054|NCT01168765|"~     Building from existing intervention strategies designed for the Mexican American population~     entitled Tu Salud Si Cuenta(TSSC) or Your Health Matters. This intervention highlights in the~     media successful role models who have changed their food choices and physical activity~     levels. In addition, the intervention designs environmental changes to help community members~     carry out recommended behavior change strategies. The purpose of this study is to test the~     efficacy of the outreach elements of the Tu Salud Si Cuenta (TSSC) media campaign, a physical~     activity and healthful food choice intervention among Mexican Americans in the Lower Rio~     Grande Valley to achieve behavioral and clinical outcomes.~   "
183055|NCT01168752|"~     The purpose of this study is to determine the maximum tolerated dose of Debio 0932 when~     administered orally, every-other-day or daily during the first 30 days, in patients with~     solid tumours or lymphoma.~   "
183056|NCT01168739|"~     The purpose of this study is to determine whether dietary quercetin supplementation effects~     thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress.~      Specific Aim I. To determine if quercetin in combination with repeated bouts of thermally~     stressful exercise will impact intestinal barrier function. The investigators will examine~     urinary lactulose excretion, plasma endotoxin,plasma quercetin, inflammatory cytokines (TNF-a~     & Il-6), anti-inflammatory cytokines (Il-10), and HSP70 and HSF-1 content of peripheral blood~     mononuclear cells.~      Specific Aim II. To determine whether quercetin's suppresses the ability of human subjects to~     acclimate to exercise/heat stress. The investigators will examine body temperatures, heart~     rates, physiological strain, sweat and plasma volume responses to standardized heat tolerance~     tests.~   "
183057|NCT01168726|"~     Excessive college student drinking represents an important public health problem for both the~     students themselves and those with whom they interact. The objective of this research is to~     better understand how to reduce such high-risk drinking by improving prevention and treatment~     programs, which will provide an overall public health benefit. Subjects in the study will be~     randomized to one of two brief intervention conditions or an education-only control~     condition. It is hypothesized that those in the intervention conditions will report greater~     reductions in alcohol use and alcohol-related problems than those in the control condition.~   "
183058|NCT01168713|"~     Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in~     the treatment of adults with moderate to moderately severe community-acquired bacterial~     pneumonia.~   "
183068|NCT01168583|"~     This study is about investigating the relationship of postoperative fluid balance,~     inflammation and acute kidney injury. This is a non-interventional study (no drug~     administration). The investigators will collect baseline demographic data, postoperative~     fluid balance status by Intake-output data, follow routine labs and collect 1 blood sample~     (0.5ml) with morning lab draws on day 1 and 5ml urine samples on day 1 and 2.~   "
183069|NCT01168570|"~     Purpose of this study is to determine whether keeping SAA on normal or near normal level will~     delay progression of renal failure in patients with amyloidosis secondary to FMF.~   "
183070|NCT01168557|"~     Electric Impedance Tomography (EIT) is a technique based on the injection of small currents~     and voltage measurements using electrodes on the skin surface generating cross-sectional~     images representing impedance change in a slice of the thorax.It is a radiation free, non-~     invasive and portable lung imaging technique. Impedance changes in lung ventilation as well~     as in lung perfusion can be shown. To investigate lung perfusion by EIT measurements, cardiac~     output measured by routinely undergone stress echocardiography at rest and stress are~     compared to parameters measured by EIT.~   "
183059|NCT01168700|"~     Many studies have addressed the relationship between metabolic syndrome and cardiovascular~     disease. Risk factors include abdominal obesity, insulin resistance, abnormal lipid profile~     and hypertension. It is proposed that this condition leads to an increase in the production~     of inflammatory substances and endothelial dysfunction.~      New therapies have been studied to improve control of metabolic disorders and reduce the~     endothelium damage. Aged garlic extract (Kyolic®) is a promising intervention that has~     antithrombotic and antioxidant properties. At the moment there is not data about the effects~     of supplementation with AGE in the endothelial function of patients with metabolic syndrome.~     Thus, the purpose of this study is to investigate if the supplementation with Kyolic® can~     alter the plasma levels of inflammatory markers, insulin and the endothelial function of~     patients with metabolic syndrome.~      Methods and design: A randomized, cross over, double-blind, placebo-controlled trial will be~     performed to assess the effects of 1.2 g of Kyolic in insulin resistance and endothelial~     function of 46 patients with diagnosis of metabolic syndrome. The participants will be~     recruited from the primary care centers from E.S.E ISABU Bucaramanga. All subjects who meet~     the inclusion criteria will be randomly assigned to two periods of 12 weeks (Kyolic and~     placebo). Control visits will be programmed monthly to verify compliance and the presence of~     adverse events. Outcome variables (endothelial function assessed by flow mediated~     vasodilation, inflammatory markers, insulin plasma levels) will be evaluated at the initial~     visit and after 12 and 24 weeks of treatment.~   "
183060|NCT01168687|"~     The overall goals of this study are to (1) expand knowledge about interactions of~     levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in~     moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to~     measure postural control (which has been used as a marker of intoxication) and the effects of~     levetiracetam on postural control.~   "
183061|NCT01168674|"~     The primary outcome of this study is to determine if predictors of response can select a~     population of patients with MDD that is effectively treatable by augmentation with~     ziprasidone.~      Major depressive disorder (MDD) is a broad category, including many forms of depressive~     illness, including those with only a single major depressive episode, those with episodic~     recurrence with intervening well states, those with chronic depressive/anxious states without~     intervening euthymia, and those with manic symptoms that do not meet threshold definitions of~     full mania/hypomania.~      In this heterogenous, large diagnostic definition, important groups of patients do not appear~     to respond well to antidepressants, and, conversely, based on observational studies, may~     respond well to neuroleptics. These predictors of response have begun to be identified and~     may serve to better design studies of neuroleptics in depressive illnesses.~      Among these predictors of response in MDD are clinical features that are more similar to~     bipolar illness than unipolar depression. These include a family history of bipolar disorder,~     antidepressant-induced mania, highly recurrent depressive episodes (>5), atypical depression,~     early age of onset of depression (< age 20), failure to respond to antidepressants, and~     antidepressant tolerance (initial response followed by later loss of response).~      The investigators propose to use these predictors to pick out patients that are more likely~     to respond to Geodon for MDD. This will be the first RCT of these predictors of depressive~     response applied to neuroleptics.~   "
183062|NCT01168661|"~     The purpose of this study is to investigate if treatment with yoga or mindfulness has a more~     profound and longstanding effect on stress and burnout than treatment with cognitive~     psychotherapy alone.~   "
183063|NCT01168648|"~     The purpose of this study is to investigate if yoga can be an effective stress management~     technique for health care personnel.~   "
183064|NCT01168635|"~     Spirometry is a recommended component of asthma diagnosis and treatment in the primary care~     setting, yet few providers report its routine use for children with asthma. Misclassification~     of asthma severity occurs when assessment is based on symptoms alone. This misclassification~     can lead to inadequate treatment, increased morbidity, and increased healthcare~     utilization/cost.~      The goal of this study is to test the effectiveness of a distance learning quality~     improvement program called Spirometry 360 developed by the interactive Medical Training~     Resources (iMTR) group at the University of Washington Child Health Institute. The Spirometry~     360 program aims to improve care for children with asthma by enhancing provider knowledge and~     self-efficacy related to the use and interpretation of office-based spirometry.~   "
183065|NCT01168622|"~     The effects of race/ethnicity on platelet function and response to antiplatelet agents will~     be assessed using 125 healthy subjects, 250 coronary heart disease patients treated with~     aspirin, and 250 coronary heart disease patients treated with aspirin and a P2Y12 receptor~     antagonist, clopidogrel or prasugrel. A minimum of 25 healthy people, 50 people taking only~     aspirin, and 50 people taking aspirin and clopidogrel/prasugrel will be recruited for at~     least 5 racial/ethnic groups.~   "
183066|NCT01168609|"~     Left atrial volume (LAV) provides the significant prognostic information in the general~     population and patients with heart disease, including acute myocardial infarction, left~     ventricular dysfunction, mitral regurgitation, cardiomyopathy and atrial fibrillation. Large~     left atrial volume, which represents chronic diastolic dysfunction, is associated with poor~     outcome, regardless of systolic function. Thereby, LAV provides a long-term view of whether~     or not the patient has the disease of diastolic dysfunction, regardless of whatever loading~     conditions are present at the time of the examination, as the hemoglobin A1C in diabetes.~     However, whether left atrial (LA) parameters could correlate with LVFP and reflect short-term~     change in left ventricular filling pressure(LVFP) remains unknown. Only one article of our~     team confirmed the relationship between LAV and LVFP in patients with severe mitral~     regurgitation by simultaneous echocardiography-catheterization. The prior report proposed a~     new parameter, LA distensibility, and disclosed its logarithmic relationship with LVFP. The~     LA distensibility precisely indicated rapid change in LVFP of patients with acute severe~     mitral regurgitation, and was even superior to mitral E/Em (early-diastolic mitral inflow~     velocity divided by early-diastolic mitral annular velocity). As left atrial pressure rises~     to maintain adequate left ventricular diastolic filling, increased atrial wall tension tends~     to dilate the chamber and stretch the atrial myocardium. Therefore, the smaller left atrial~     stretchability, the more pressure left atrium (LA) faces to. The first objective of this~     study was to test the value of LA distensibility for assessing LVFP, particularly in patients~     with acute myocardial infarction. The second objective was to assess the prognostic value of~     LA distensibility.~   "
183071|NCT01168544|"~     Vitamin D deficiency is common in older persons, in particular in residents of nursing homes.~     This is mainly explained by the fact that older persons do not often go outside in the~     sunshine. On top of that the capacity of the skin to synthesize provitamin D is decreased and~     dietary vitamin D intake is low. Vitamin D deficiency leads to osteoporosis, falls and~     fractures. To prevent morbidity and mortality due to falls and fractures it seems logical to~     supplement vit D in order to correct the deficiency. The advised daily dose of vit D~     supplementation is 800 IU. Several studies showed that with this dose the required serum~     25(OH)D levels will not be reached.~      primary objective of this study is:~        -  to investigate whether with a loading dose based on body weight and baseline serum~          25(OH)D level more patients reach adequate serum 25(OH)D levels compared to 800 IU a~          day.~        -  to determine the best consolidation treatment.~      Secondary objective~        -  is a loading dose based on body weight and baseline serum 25(OH)D level safe to use in~          residents of nursing homes.~        -  is there a relation between the increase in serum 25(OH)D level and muscle strength~          (handgrip strength).~        -  is there a relation between the increase in serum 25(OH)D level and mobility (2 minute~          walk test).~      Study design:~      Randomised trial with 3 study groups:~        -  Group 1a. loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU~          vit D3/month consolidation therapy.~        -  Group 1b. loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU~          vit D3/month consolidation therapy.~        -  Group 2. 800 IU vit D3/ dag.~      Study population:~      Vitamine D deficient residents of nursing homes, 65 years or older.~   "
183072|NCT01168531|"~     Multimodal analgesia may be important for optimal postoperative pain treatment and~     facilitation of early mobilization and recovery. This study investigated the analgesic effect~     of pregabalin and dexamethasone in patients undergoing lumbar spinal surgery.~   "
183073|NCT01168518|"~     This observational study is a non-interventional multi-centre, prospective study.~      The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing~     leads. We plan to assess the acute and short term lead dislodgment rate (within the first~     three months following implantation) correlated with the type of lead (active- or passive-~     fixation). Further, we are collecting data related to leads handling and leads electrical~     performances~   "
183074|NCT01168505|"~     Study to evaluate the efficacy of intravenous iron supplementation in the prevention of~     anemia in patients receiving (neo)adjuvant breast cancer regimens.~   "
183075|NCT01168492|"~     The purpose of this study is to determine whether ketamine, midazolam, and meperidine are~     more effective than midazolam and meperidine alone for procedural sedation and analgesia in~     pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side~     effects and the necessity of rescue doses.~   "
183076|NCT01168479|"~     Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in~     local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy~     fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35%~     in the high-dose arm. Therefore further dose escalation seems to be required. A feasibility~     study up to appr. 85 Gy on the entire prostate has already been performed and showed~     acceptable toxicity when combined with adequate position verification. Higher doses to the~     entire prostate are expected to increase severe toxicity. As local recurrences only occur at~     the site of the primary macroscopic tumour area the next step in increasing the dose should~     be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest~     of the prostate to the current gold standard dose. Feasibility of this approach has been~     shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate.~   "
183077|NCT01168466|"~     This study measures whether the symptoms of frontotemporal dementia (FTD) can be successfully~     treated by (a) biofeedback training to increase brain blood flow, (b) biofeedback to increase~     the frequency of the brain's dominant brainwave rhythm, and (c) rhythmic stimulation to~     increase the brain's dominant brainwave frequency.~   "
183078|NCT01168453|"~     This study was performed to ultrasonographically demonstrate the changes in relationship~     between the right internal jugular vein (IJV) and an anatomical landmark in two different~     head positions: neutral and rotational.~   "
183079|NCT01168440|"~     VHL patients may benefit from sunitinib. This study will investigate the following objectives~     :~      PRIMARY OBJECTIVE~        -  To determine the objective response rate according to RECIST criteria, in VHL patients~          with advanced tumors or tumors untreatable by other means, and treated with sunitinib.~      SECONDARY OBJECTIVES~        -  To evaluate the safety and tolerability of sunitinib in VHL patients according to the~          NCI-CTC criteria Version 3.0.~        -  To determine the following time-to-event endpoints: overall survival, time to disease~          progression, progression free survival, time to response and duration of response.~        -  To evaluate quality of life in VHL patients receiving sunitinib.~   "
183080|NCT01168427|"~     The purpose of this study is to gather evidence about the safety and feasibility of~     performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office~     or clinic setting rather than the traditional hospital operating room, cardiac~     catheterization or electrophysiology (EP) laboratory setting.~   "
183081|NCT01168414|"~     This is a single-center, cross-over comparison parallel group randomized trial designed to~     evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8~     weeks each.~   "
183082|NCT01168401|"~     Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage~     levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with monophosphoryl~     lipid A (MPL) and aluminum hydroxide (AlOH) compared to controls. Subjects will receive two~     doses, by intramuscular (IM) injection, 28 days apart.~      The hypotheses for this study are:~        -  The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine~          will be similar to the incidence of adverse events after other IM vaccines including~          CERVARIX® which contains MPL and AlOH.~        -  Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose.~        -  The post-vaccination serum antibody responses, the number of antibody secreting cells~          (ASC), including homing markers, and memory B-cell responses directed against norovirus~          antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.~   "
183316|NCT01165346|"~     Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.~   "
183083|NCT01168388|"~     Movement disorder involve recurring or constant muscle contractions causing squeezing or~     twisting movement, such as hemifacial spasm, blepharospasm, cervical dystonias etc. The most~     common focal dystonia was cervical dystonia in western countries according to previous~     studies, which is different from China in Chinese neurologists' opinion. And there is no such~     survey. So the investigators are conducting a movement disorder survey in east China to~     confirm it.~   "
183084|NCT01168375|"~     80 diabetic patients underwent vitrectomy and had no history of Eye herpes infection,~     Refractive surgery, Autoimmune disease, Immune deficiency will be randomized into two groups~     (double blind)to evaluate the role of umbilical cord serum therapy on improvement of corneal~     epithelial defect following diabetic vitrectomy. Both groups will take the conventional~     medication including Chloramphenicol, Betamethasone, Cycloplegic eye drops besides the case~     group will take umbilical cord serum eye drop in the eye operated. After surgery the corneal~     epithelial defect will be measured by slit lamp.~   "
183085|NCT01168362|"~     Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of~     coronary heart disease. The investigators aimed to characterize coronary artery disease in~     subjects with cardiovascular risk or not, and in particular plaque natures depending on~     different status of cardiovascular risk. Especially,the investigators will evaluate the~     relationships between the pericardial fat and severity of stenosis as well as plaque~     characteristics using logistic regression models.~   "
183086|NCT01168349|"~     This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in~     daily routine practice in cancer patients with anemia. Data will be collected from patients~     who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will~     be followed for 28 weeks.~   "
183087|NCT01168336|"~     The study aims to evaluate the safety and pharmacokinetics of extended release and standard~     formulations of betahistine when administered as monotherapy and as compared to their safety~     and pharmacokinetics when co-administered with olanzapine and to determine potential dose~     limiting toxicities and/or drug-drug interactions affecting the pharmacokinetics or safety of~     either medication, with particular emphasis on somnolence and weight gain secondary to~     olanzapine treatment~   "
183088|NCT01168323|"~     Two memory research findings (the spacing and testing effects) can dramatically improve~     retention of learning, but they have largely have been ignored by educators. The researchers~     have developed a novel form of online education (termed 'spaced education') based on these~     two effects which has been shown in randomized trials to improve knowledge acquisition and~     boost learning retention. Using prostate cancer screening as an experimental system, the~     researchers investigated whether spaced education could durably improve clinicians'~     behaviors, not just their knowledge.~   "
183089|NCT01168310|"~     This is a randomized, double-blind, multi-dose, parallel group trial which will assess the~     pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with~     COPD.~   "
183090|NCT01168297|"~     In 1995 we conducted a cross-sectional study to identify the effects of traditional and~     western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima~     Indians in Mexico and the United States. The Mexican Pimas live in a remote mountainous~     region and at that time had experienced little change from their traditional lifestyle.~     Nothing was known about their T2DM prevalence. A similar number of non-Pima Mexicans live in~     the same village. In contrast to the Mexican Pimas, the U.S. Pimas live in more westernized~     society and have a high prevalence of diabetes. We found that although T2DM and obesity were~     more prevalent in Mexican Pimas than non-Pimas, both Mexican groups had a significantly lower~     prevalence of these disorders than U.S. Pimas. The lifestyle of the Mexican population~     studied included a dramatically higher level of physical activity and a diet higher in fiber~     and lower in calories derived from fat compared with the U.S. Pimas. Since the U.S. and~     Mexican Pimas share a similar gene pool we concluded that even in populations genetically~     prone to T2DM and obesity, their development is determined largely by environmental~     circumstances.~      Since 1995 the environmental circumstances of the Mexican Pimas and non-Pimas have changed.~     The electrical supply to the region has increased, cars have become more prevalent and~     grocery stores have appeared. The impact of these changes on T2DM and obesity has not been~     examined. In light of these events, we propose to: 1) compare the current prevalence of T2DM~     and obesity in Mexican Pimas and non-Pima Mexicans to that present in 1995 with the same~     measures used previously, including height, weight, waist circumference, body composition by~     bioelectrical impedance, oral glucose tolerance and HbA1c; 2) compare current diet, physical~     activity and total energy expenditure in both Mexican Pimas and. non-Pima Mexicans using the~     same methods as the 1995 study to the previous results and 3) document the frequencies of~     T2DM and obesity-associated genetic variants in Mexican Pimas compared with U.S. Pimas and~     non-Pima Mexicans.~   "
183091|NCT01168284|"~     In recent years, there have been a growing number of individuals diagnosed with Autism~     Spectrum Disorders (ASD). As such, this increase has expanded the number of caregivers of~     children with ASD. Research has shown that having a child with an ASD is stressful for~     caregivers and their families. More specifically, prior research suggests that caregivers of~     children with ASD may find it difficult to maintain feelings of control and to cope with the~     overall physical and emotional demands of caring for their child. A previous study of~     caregivers of children with ASD found that caregivers felt a lack of personal control over~     aspects of their child s condition and also found it difficult to cope with various demands~     of caregiving. Furthermore, this study found that greater levels of perceived personal~     control and the use of problem-focused coping strategies were associated with caregivers~     adaptation to their child s condition. As such, the goal of our research is to conduct a~     feasibility study using a coping effectiveness training (CET) intervention designed to~     enhance perceived personal control (PPC) and coping efficacy in caregivers of children with~     ASD. There has been a growing interest in developing interventions targeted at constructs~     involved in the adaptation process. However, there have been few studies of interventions~     targeting predictors of adaptation such as PPC and coping efficacy. Research has shown that~     the CET intervention can enhance coping efficacy in several other populations. This~     intervention also incorporates appraisals of one s ability to change a particular situation.~     The conceptual framework for our study was adapted from Lazarus and Folkman s Transactional~     Model of Stress and Coping. A cross-sectional randomized treatment-control design is proposed~     to evaluate the use of a CET intervention intended to enhance PPC and coping efficacy.~     Caregivers of children with ASD will be recruited from support groups, autism resource~     centers, and four clinics. Participants randomized to the treatment group will be asked to~     complete baseline and follow-up surveys and two 1.5-hour individualized in-person sessions.~     Participants randomized to the control group will be asked to complete baseline and follow-up~     surveys and two 1.5-hour individualized in-person client-centered discussion sessions. The~     main outcome measures will be participation, reasons for withdrawal, participants experiences~     within the intervention setting and their experiences in applying the intervention, PPC,~     coping efficacy, and coping effectiveness.~   "
183092|NCT01168271|"~     Malaria caused by Plasmodium falciparum continues to be a global problem with devastating~     consequences. A greater understanding of the immunologic and parasitologic factors associated~     with infection and disease is badly needed, and will accelerate the development of highly~     protective vaccines for both mothers and children. Pregnancy malaria is associated with low~     birth weight, maternal anemia, and gestational hypertension, and both inflammation and the~     fetal response to infection may contribute to these poor outcomes. Childhood malaria is a~     major cause of mortality, and we have found that risk of childhood malaria is related to in~     utero exposure to pregnancy malaria, as well as other host factors like iron status and~     constitutive cytokine levels. Pregnancy malaria is caused by a distinct parasite binding~     phenotype, and as our primary hypothesis in this study we speculate that severe childhood~     malaria parasites may also have distinct features. A longitudinal cohort study will be~     conducted in Ouelessebougou, Mali an area of intense seasonal transmission. Up to 2000~     pregnant women and their infants and 2000 children ages 0 - 3 will be enrolled and followed~     to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples~     obtained. In addition, 2000 febrile children up to age 10 years will be enrolled at the~     Ouelessebougou district health centers or the Gabriel Tour(SqrRoot)(Copyright) Pediatric~     Hospital in Bamako, Mali, with acute and convalescent samples being obtained and 500 pregnant~     women enrolled at the health centers and hospital in Ouelessebougou district or the Gabriel~     Tour(SqrRoot)(Copyright) Hospital in Bamako for a case-control study on pregnancy malaria and~     preeclampsia. Clinical, parasitologic and host response (including immunologic) endpoints~     will be analyzed using appropriate statistical methods, including possible confounders, to~     determine factors associated with infection and disease in pregnant woman and young children.~   "
183093|NCT01168258|"~     Background:~      - Diabetic macular edema (DME) is a common condition in people with diabetes. DME occurs when~     blood vessels in the eye leak fluid, resulting in swelling inside the back of the eye and~     progressive vision loss. Research has shown that good blood sugar control can reduce the risk~     and severity of DME. However, not all diabetic patients with poor blood sugar control develop~     DME, and some patients develop DME despite excellent blood sugar control. This suggests that~     other factors, such as genes or inherited traits, may predispose or protect a diabetic~     patient from developing DME.~      Objectives:~      - To investigate genetic factors that may influence the development of diabetic macular~     edema.~      Eligibility:~      - Individuals at least 18 years of age who have type 2 diabetes, with or without diabetic~     macular edema.~      Design:~        -  The study will require one visit to the National Institutes of Health eye clinic.~        -  Participants will be screened with a medical history and basic eye examination.~          Individuals who have certain eye diseases other than DME may not be allowed to enroll in~          the study.~        -  Participants will provide a blood sample, and will receive fluorescein angiography (an~          injection of fluorescein dye, after which a camera will take pictures of the dye as it~          flows through the blood vessels in the eye).~        -  No treatment will be provided as part of this protocol.~   "
183094|NCT01168245|"~     The aim of this study is to examine if combined treatment with TMS and cognitive training~     (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral~     symptomatology of mild to moderate Alzheimer's disease (AD) patients.~   "
183095|NCT01168232|"~     This phase II trial is studying the side effects and how well ixabepilone works in treating~     patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as~     ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the~     cells of by stopping them from dividing.~   "
183096|NCT01168219|"~     This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate, and~     anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in~     treating patients with high-risk myelodysplastic syndrome and older patients with acute~     myeloid leukemia. Giving low doses of chemotherapy, such as busulfan and fludarabine~     phosphate, before a donor stem cell transplant helps stop the growth of cancer cells. It also~     stops the patient's immune system from rejecting the donor's stem cells. The donated stem~     cells may replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-vs-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving anti-thymocyte globulin before~     transplant and giving azacitidine, tacrolimus, and methotrexate after the transplant may stop~     this from happening.~   "
183097|NCT01168206|"~     The association of nutritional supplement TK3 to conventional treatment of cancer patients~     reduces the intensity and frequency of toxic effects and side effects caused by adjuvant or~     palliative treatments for the protection of healthy tissues, resulting in a better quality of~     life.~   "
183098|NCT01168193|"~     Surgical complications may be very serious and are often under-reported. The aim of this~     study it to document and study all the postoperative complications at our department during~     one year using a novel grading system.~   "
183099|NCT01168180|"~     The purpose of this study is to evaluate the efficacy of traditional Thai massage on pain~     intensity, pressure pain threshold, muscle tension, anxiety, cervical range of motion,~     patient satisfaction and side effects in the treatment of scapulocostal syndrome.~   "
183100|NCT01168167|"~     Recent clinical trials of combination antiretroviral therapy (cART) containing the first~     approved integrase inhibitor (i.e. raltegravir) have demonstrated a more rapid decay of HIV-1~     RNA in plasma, compared to conventional potent antiretroviral combinations. This was observed~     especially during the early phase (up to week 12) following initiation of cART.~      To explain this, two mechanistic hypotheses have been developed:~        1. - Macrophage reservoir death hypothesis. A major source of virus production during the~          second phase decay are believed to be long-lived infected cells with continuous virus~          production - e.g. macrophages. An accumulation of unintegrated, episomal HIV-1 cDNAs can~          promote apoptosis (Li et al. Embo J. 2001;20: 3272). In case of HIV superinfection of~          such a productively infected cell, an INI-based cART may induce apoptosis and thus~          contribute to a decrease in HIV RNA load during second phase decay. However, no study~          has thus far addressed the consequences of INI treatment on HIV-1 cDNA species on any~          cell population in vivo.~        2. - Resting CD4 T-cell reservoir integration block hypothesis. Resting CD4 T-cells may~          represent a substantial reservoir for HIV replication during the second phase decay as~          well. A special characteristic of these cells is that HIV-1 cDNA is typically localized~          to the nucleus in a not-integrated form (Chun et al., PNAS 1997;94:13193). These resting~          cells likely integrate HIV-DNA upon activation and then contribute to HIV viremia and~          viral spread. Conceptually, integration could be prevented by RGV, but not by RTI or PI.~          An accumulation of circular episomal HIV-1 cDNA species may also be a consequence of RGV~          treatment in this cell type.~      Patient disposition:~      To explore raltegravir-induced shifts in HIV-1 cDNA species in vivo, this non-interventional~     clinical observation investigates the dynamics of the three major HIV-1 cDNA species (total~     HIV-1 cDNA, HIV-1 integrants in the host cell genome, episomal HIV-1 2-LTR circles) over a~     period of 4 months in two groups of patients starting off cART from a single study center.~     Patients who begin cART in regular clinical routine with 2N(t)RTI plus either (n=10 patients)~     raltegravir or (n=10 patients) a boosted protease inhibitor/ alternatively an NNRTI will be~     offered to participate in this observation. Only patients are offered to participate in this~     trial if no other antiretroviral drugs than the above mentioned and no concomitant drugs with~     relevant impact on antiretroviral's pharmacokinetics are administered. At time of study~     inclusion, patients should be characterised by a HIV-1 RNA load of >5,000 copies/mL and~     CD4-cell count of >200/µL within 12 weeks before cART initiation.~      Preliminary analyses of PBMCs from HIV-infected patients indicate that all three major HIV-1~     cDNA species can be quantified by real-time PCR under these baseline conditions.~   "
183101|NCT01168154|"~     The aim of this study is to evaluate the effectiveness and the tolerability of the~     Lactobacillus reuteri in the control of the diverticular disease symptoms and in the~     prevention of acute diverticulitis episodes.~   "
183102|NCT01168141|"~     This is a prospective study in which patients with castrate-resistant prostate cancer and~     bone metastases will undergo imaging, donate blood, bone marrow and urine samples, and where~     possible primary tumour and bone metastatic tissue, before and during treatment with ZD4054,~     an orally active specific endothelin-A antagonist. The samples will be used primarily for~     biomarker studies, and it is hypothesized that these will inform on the mechanism of action~     of this drug. Magnetic Resonance Imaging (MRI) will be performed to evaluate emerging~     functional imaging endpoints as markers of early response in bone metastatic prostate cancer.~   "
183103|NCT01168128|"~     Canadian Critical Care Nutrition Guidelines assist health practitioners in identifying best~     practices for feeding critically ill patients. However, guidelines have resulted in little~     change in Intensive Care Unit (ICU) practices, possibly because barriers to change differ~     between ICUs. Change may be facilitated if strategies specifically address identified~     barriers. The investigators hypothesize that barriers are inversely related to nutrition~     performance. Tailoring change strategies to overcome barriers to change will reduce the~     presence of these barriers and lead to improvements in nutrition practice.~   "
183104|NCT01168115|"~     The purpose of this study is to evaluate the performance of a near-infrared transmission~     measurement in blood samples collected from healthy volunteers. We propose that NIR~     spectroscopic blood glucose measurements in healthy patients are as accurate as handheld~     glucometers and a Yellow Springs Instrument (YSI). We will also evaluate in vitro blood~     samples spiked with pharmacological interferents to test if the spectroscopic glucose~     measurement is affected by common medications.~   "
183105|NCT01168102|"~     The objective of this study is to assess the performance of a noninvasive device for the~     detection of blood alcohol levels.~   "
183106|NCT01168089|"~     Luminous Medical, the Sponsor is developing a glucose monitor for the critical care setting.~     The Sponsor's ultimate goal is to provide a near-continuous blood glucose monitor that~     automatically measures glucose. In this study, Luminous will evaluate the performance of the~     near-infrared measurement in blood samples collected from patients in the intensive care unit~     setting.~   "
183107|NCT01168076|"~     The objective of this study is to assist in the development of a noninvasive device for the~     accurate measurement of blood glucose levels.~   "
183108|NCT01168063|"~     H pylori eradication failure with recommended triple therapy is mainly related to antibiotic~     resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine~     practice. A molecular test of antibiotic resistance easy to perform is now available. The aim~     of the study was to compare eradication rates obtained with the standard treatment and with a~     treatment guided by the results of the molecular detection of antibiotic resistance.~   "
183109|NCT01168050|"~     NILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of~     Nilotinib in first or second line treatment of primary melanomas , stage III unresectable~     melanomas, or Stage IV melanomas with c-KIT mutation or amplification. The primary objective~     is overall response rate (partial and complete response) according to RECIST 1.1 criteria,~     assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months~     therapy with Nilotinib 800 mg/d. Secondary objectives include:~        -  Disease control rate (complete, partial response and stable disease)~        -  Metabolic response~        -  Tolerance NCI CTCAE Version 3.0~        -  Biomarkers associated to response and disease control.~   "
183110|NCT01168037|"~     The aim of this study is to prospectively compare the perioperative mortality severe~     morbidity and the costs of endovascular versus conventional surgical repair of pararenal,~     supra-renal and type 4 THORACO-abdominal aortic aneurysms.~      The primary goal of the study is to demonstrate a significant drop in 30-day mortality and~     life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from~     the literature, that the average 30-days mortality is 3% after endovascular repair and 10%~     after open surgery justifies the design of a prospective study between endovascular therapy~     (250 patients (amendment) treated in 8 University hospitals with significant experience of~     the technique) and open repair (660 similar patients analyzed form the national database of~     the MOH).~   "
183111|NCT01168024|"~     The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey~     Medical CINCOR™ Contrast Removal System.~   "
183112|NCT01168011|"~     This is a phase 1 study in which 2 to 72 patients with advanced cancer will receive oral~     doses of rigosertib, a new investigational (unapproved) anti-cancer drug. The objective of~     the study is to determine the highest dose of drug that can be given safely. The study will~     start by testing a low dose. If this dose is safe, then, higher and higher doses will be~     tested as long as the previous lower dose was safe. Safety will be determined by looking for~     any side effects or unusual laboratory values. It is important to know the highest safe dose~     so that additional studies can be done. The drug will be given in the form of capsules twice~     or three times a day for 21 consecutive days of 21-day cycles.~   "
183113|NCT01167998|"~     Malignant Melanoma is a deadly skin cancer that can be cured if diagnosed early. To date~     atypical pigmented skin lesions are diagnosed by appearance alone and many moles and lesions~     are excised unnecessarily and on the other hand malignant lesions are missed and diagnosed~     too late. In this study a protein conjugated to a florescent dye is spread on a suspicious~     pigmented lesion, the hypothesis is that this protein binds to malignant cells only and thus~     with a special camera that picks up the dye we can find pigmented lesions with early~     malignant transformation.~   "
183114|NCT01167985|"~     The effect of Antibacterial Nanoparticles, Incorporated in root canal sealer material and in~     provisional restoration is going to be examined. Two different tests are planned: (1)~     clinical and radiological evaluation of root canal sealer.(2) An evaluation in the laboratory~     the efficacy of provisional restoration during root canal treatment.We assume, based on our~     previous laboratory studies that show antibacterial properties, that the incorporation of the~     nanoparticels will improve the treatment outcome.~   "
183115|NCT01167972|"~     The main objective of the study is to determine the proportion of patients with M + mutation~     status among patients with Non Small Cell Lung Cancer adenocarcinoma.~   "
183116|NCT01167959|"~     The purpose of this study is to determine the effect of gastric banding or gastric bypass on~     hypothalamic morphology and function, gut hormones and systems biology in obese subjects with~     and without type 2 diabetes.~   "
183117|NCT01167946|"~     Systemic Pulse Glucocorticoids have been shown to be effective in widespread Alopecia areata~     but not the totalis, universalis or ophiasic type. Whether the failure is due to inadequate~     dosing, inadequate frequency or other factors is a matter of debate. The investigators~     decided to conduct this study using the oral pulse steroid, however with higher doses and~     more frequent pulses to patients with severe forms of Alopecia areata.~   "
183118|NCT01167933|"~     The purpose of this study is to~        -  compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg~          tablets of MercK & Co. Inc, USA in healthy subjects under fed conditions~        -  monitor adverse events and to ensure the safety of subjects.~   "
183159|NCT01167400|"~     Exercise has been linked to cognitive health, but few older adults exercise at recommended~     levels. Cybercycling may provide additional cognitive benefits due to increased motivation to~     ride the interactive 3D tours. Participants will be randomly assigned to three months of~     either cybercycling or traditional stationary biking; and they will complete comprehensive~     evaluations before and after exercise. Older adults are expected to show significant~     neuropsychological, physiological and behavioral gains.~   "
183317|NCT01165333|"~     The aim of the study is to determine the safety of Cilengitide in combination with radiation~     therapy.~   "
183119|NCT01167920|"~     This is a prospective, randomized controlled trial designed to determine whether blue tooth~     and telephone technology can be utilized to successfully relaying home blood pressure~     information electronically to healthcare providers so that timely and more frequent treatment~     interventions can be instituted to optimize and reach goal blood pressure level for an~     individual as compared to usual care. The primary study outcomes are improvement in systolic,~     diastolic, and blood pressure control and time to control blood pressure. Secondary outcomes~     are proportion of patients controlled to blood pressure goal at the end of the study,~     adherence to blood pressure monitoring and utilization of VHC model.~      If this is successful and cost-effective such technology and interventions could be utilized~     on large scale to improve the care and proportion of hypertensive patients achieving goal~     blood pressure in the United States.~   "
183120|NCT01167907|"~     A nerve block catheter is a small tube placed next to a nerve through a needle, and the~     needle is then removed. Numbing medicine is dripped through the tube to reduce pain sensation~     from the nerve.~      The purpose of this research study is to test whether the placement of a second nerve block~     catheter, rather than a single injection for the saphenous nerve block will improve pain~     relief and/or reduce pain medication needed after surgery enough to justify two nerve block~     catheters.~      There are two nerves that carry pain sensations from the ankle, the large (sciatic) nerve and~     the smaller (saphenous) nerve. Patients undergoing ankle fusion or fracture surgery at Wake~     Forest University typically have a nerve block catheter placed next to the sciatic nerve to~     give local anesthetic (numbing medicine) for 24-72 hours. In addition, a single injection of~     local anesthetic is usually performed to block the saphenous nerve for 12-16 hours~     postoperatively.~   "
183121|NCT01167894|"~     The purpose of this study is to~        -  compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg~          tablets of MercK & Co. Inc, USA in healthy subjects under fasting conditions~        -  monitor adverse events and to ensure the safety of subjects.~   "
183122|NCT01167881|"~     This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for~     BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2~     diabetes mellitus and insufficient glycaemic control.~   "
183123|NCT01167868|"~     This is a single and multiple ascending dose study in healthy male and female (of non-child~     bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and~     blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid~     arthritis.~   "
183124|NCT01167855|"~     The overall goal of this proposal is to examine the efficacy of a school-based asthma~     telemedicine intervention in a predominately minority, low-income rural pediatric population.~   "
183125|NCT01167842|"~     This study will analyze tumor tissue from patients with known genetic mutations (BRCA1,~     BRCA2, CHK2, etc) who have tumor tissue available from two surgeries, either~     primary/recurrent, or two different anatomical sites.~   "
183126|NCT01167829|"~     The purpose of this study is to test how the body absorbs a new form of oral testosterone~     (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at~     the University of Washington to monitor blood testosterone levels over a 24-hour period.~   "
183127|NCT01167816|"~     The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and~     gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to~     determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.~   "
183128|NCT01167803|"~     Obesity is increasing in France, resulting in an increased demand for bariatric surgery.~     However obesity also alters physiopathological pathways and the pharmacokinetics of~     anesthestic agents. The investigators objective is to compare, among morbidly obese patients,~     the immediate and intermediary emergence kinetics after balanced anesthesia using~     remifentanil associated either with desflurane (reference arm) or with xenon (experimental~     arm).~   "
183129|NCT01167790|"~     Diagnosis of oral squamous cell carcinoma is always too late. Due to this delay for~     diagnosis, prognosis is very bad. It has been demonstrate that systematic oral examination~     decrease mortality in tobacco and alcohol consumers population (Sankaranarayanan and al.~     Lancet 2005, 4, 1927-1933 ). An other study has demonstrate that autofluorescence is a useful~     technic for detection of dysplasia and squamous cell carcinoma that cannot be seen with~     conventional oral examination((Poh CF Wink Cancer Res on 2006 ( 22 ): 6616-22; Poh CF Head~     Neck 2007 ( 1 ) 7 71-6).However autofluorescence has never been evaluated has a screening~     tool for systematic oral examination and the reproductibility has never been studied.~   "
183130|NCT01167777|"~     Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification~     assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia~     trachomatis (CT) and Neisseria gonorrhoeae (GC).~   "
183131|NCT01167764|"~     Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is~     no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a~     randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of~     hemoptysis.~   "
183132|NCT01167751|"~     One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason~     is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis~     which due to congestive heart failure.~      One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the~     cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method~     to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies~     have shown that stem cell trans plantation to myocardial infarcted zone can improve heart~     contractile function.~      The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation~     in patients with myocardial infarction.~   "
183205|NCT01166802|"~     The aim of this study is to develop and validate a questionnaire (non-invasive technique) to~     identify patients who are hypervigilant for noxious visceral sensations and who show a lower~     threshold to report pain. This questionnaire would be useful in studies investigating the~     role of visceral pain hypervigilance and pain sensitivity in the comorbidity of IBS with~     other somatic disorders.~   "
183318|NCT01165320|"~     The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in~     Japanese children and adolescents with documented Candida or Aspergillus infections.~   "
183133|NCT01167738|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Metformin hydrochloride may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not~     yet known if combination chemotherapy is more effective with or without metformin~     hydrochloride in treating patients with metastatic pancreatic cancer.~      PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin~     hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin~     hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride,~     capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic~     pancreatic cancer.~   "
183134|NCT01167725|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to~     several degrees above normal body temperature and infusing it into the area around the tumor~     may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor~     cells. It is not yet known whether standard therapy is more effective with or without surgery~     followed by mitomycin C.~      PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery~     and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon~     cancer~   "
183135|NCT01167712|"~     This phase III clinical trial studies two different dose schedules of paclitaxel to see how~     well they work in combination with carboplatin with or without bevacizumab in treating~     patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or~     fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called~     a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that~     tumors need to grow. It is not yet known whether giving paclitaxel with combination~     chemotherapy once every three weeks is more effective than giving paclitaxel once a week in~     treating patients with ovarian, primary peritoneal, or fallopian tube cancer.~   "
183136|NCT01167699|"~     The main objective of the study is to evaluate the patient preference for pain treatment with~     respect to quality of life in patients with moderate to severe non malignant pain. Patients~     who have insufficient pain relief and/or unacceptable side effects with the previous~     analgesic treatment WHO step 1 or 2 and require around-the-clock opioid therapy can be~     included in the study. The WHO step I or II analgesics will be compared with the new study~     medication OXN (oxycodone/naloxone).~   "
183137|NCT01167686|"~     General:Prospective, randomized, double blind controlled trial of the food supplement~     GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with~     upper respiratory infection.~      Hypothesis: The food supplement GOLDTRAIN PLUS will be superior to placebo in shortening the~     time to recovery from the disease symptoms.~      Study design and outcome measures:Study population of 182 generally healthy subjects with~     acute respiratory infection randomized in 1:1 ratio to active supplement versus placebo~     treatment, with randomization stratified by site. The study supplement administration will be~     continued for 7 days, and patient global assessment (PGA) will be the main primary~     measurement tool, based on a self-reporting questionnaire filled and monitored every 12 hours~     for 7 consecutive days. Throat and nasal swabs determining type of viral infection, will be~     taken at inclusion of patient and a number of blood tests at the end of treatment to look for~     any adverse effects of the medication.~      Analysis and conclusion: All data-from the filled questionnaires, clinical follow up and~     laboratory studies will be analyzed by multivariate analysis to determine the efficacy of the~     supplement and its correlation to the clinical and laboratory parameters.~   "
183138|NCT01167673|"~     Irritable bowel syndrome (IBS) causes many symptoms, including abdominal pain, irregular~     bowel movements and bloating. It may be caused by loe degree inflammation of the intestine.~     The ingredients of coltect which contains green tea, selenium, and curcumin have been proven~     very safe and have anti inflammatory and anti oxidant activity. The aim of the study is to~     see whether the use of Coltect can improve symptoms in IBS patients.~   "
183139|NCT01167660|"~     The purpose of this study is to assess the reliability of a new non-invasive device to assess~     the blood coagulation status among term and preterm babies.~   "
183140|NCT01167647|"~     Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when~     infections including tuberculosis (TB) are not strongly suspected. However, the value of this~     practice has been poorly defined.~   "
183141|NCT01167634|"~     This is a 4-arm, randomized controlled trial to evaluate the effectiveness of financial~     incentives to motivate and sustain long-term weight loss. The study will recruit eligible~     employees at a large health management company to participate in a 6-month weight loss~     program and have weight measurements for an additional 3-month follow-up period. The primary~     outcome measure in this randomized controlled trial will be pounds of weight lost. The~     experimental groups will include variations of deposit contracts (participants put their own~     money at risk, and lose that money if they fail to achieve their weight loss goal) and fixed~     payments. The use of deposit contracts is a powerful mechanism for inducing behavior change~     that is based on loss aversion, a psychological concept first described by Nobel Prize winner~     Daniel Kahneman and Amos Tversky in 1979. A deposit contract takes advantage of the fact that~     people typically feel the pain of a loss more than the pleasure of a gain, increasing ones~     motivation to reach a goal.~      The study hypotheses are 1) mean weight loss will be greater in all intervention groups~     compared to the control group by the end of 24 weeks; and 2) individuals in the intervention~     groups will have a lower mean weight at the end of the 3-month follow-up period than~     individuals in the control group.~   "
183206|NCT01166789|"~     The purpose of this research study is to determine how Lubiprostone, a medication used to~     treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to~     reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the~     secretion of chloride, water and sodium. The increased fluid causes food residue to move~     through the bowel more quickly and makes the stools softer. First, we want to test the idea~     that Lubiprostone works by making a person less sensitive to pain. Second, we want to confirm~     that Lubiprostone decreases the time it takes fecal matter to travel through your GI tract,~     referred to as transit time.~   "
183142|NCT01167621|"~     The study is intended to evaluate the hemodynamic and the indexed extrapulmonary lung water~     (ELWI) changes in patients treated by high frequency oscillation-ventilation (HFO-V) for~     refractory acute respiratory distress syndrome (ARDS). HFO-V may be used as rescue treatment~     in refractory ARDS but its hemodynamic impact is discussed. Moreover, as Extra Vascular Lung~     Water (a transpulmonary thermodilution parameter) was proven to be an independent mortality~     factor in ICU-patients, the investigators decided to monitor it in all ARDS patients who~     ended up needing HFO-V, from HFO-V plugging under 72 hours of this type of ventilation. All~     ARDS patients underwent high Positive End Expiratory Pressure (PEEP) with protective~     ventilation and those who remained below a PaO2/FiO2 ratio of 120 after 24h will be~     considered as refractory ARDS patients and, therefore eligible. They will be monitored by~     the transpulmonary thermodilution PiCCO technique (Pulsion Medical System. Munich, Germany)~     and placed under HFO-V. Both transpulmonary thermodilution measurements (ELWI , Cardiac~     Output, Global End-diastolic Volume) and standard transthoracic echocardiographic~     measurements (Ejection Fraction, End-diastolic Right and Left Ventricular Area, preload~     indexes) were be performed from HFO-V plugging to Day 3. The investigators suggest that ELWI~     will be correlated to HFO-V responsiveness and that cardiac output will not change at the~     HFO-V plugging, regardless of preload indexes variation. Inclusion will be proceeded over a 2~     year period and, according to the population, the investigators expect about 50 eligible~     patients.~   "
183143|NCT01167608|"~     Parkinson's disease (PD) is the second most common neurodegenerative disorder in the elderly.~     In most people, the illness is complicated by co-occurring psychiatric problems such as~     depression and anxiety. These non-motor concerns negatively affect the course and management~     of the disease, often leading to poor outcomes for both patients and their families. Despite~     these deleterious consequences, psychiatric symptoms in PD are both underreported by patients~     as well as under-recognized and under-treated by health care providers.~      The primary purpose of this study is to identify and describe barriers to mental healthcare~     utilization for people with Parkinson's disease. Secondary objectives include the assessment~     of attitudes and preferences regarding the need for mental health services in the PD~     community and the acceptability of telehealth interventions as a method for improving access~     and quality of care. In order to accomplish these aims, participants will be asked to fill~     out an anonymous survey which will take about 15-30 minutes to complete. To best accommodate~     PD patients with varying levels of disability, participants will have the option to complete~     the survey online, on paper, or over the phone. The information obtained from this study will~     be used to support future treatment development efforts (i.e., phone and internet based~     interventions, community based trainings with local providers) intended to improve access and~     quality of mental health care for people with PD. To the best of the investigators knowledge,~     this is the first study to systematically examine barriers to mental healthcare utilization~     in PD in a national sample.~   "
183144|NCT01167595|"~     Critically ill patients are consistently underfed. Feeding protocols are standardized system~     tools used to guide nutrition practices, but to date have failed to improve delivery of~     nutrition. The PEP uP Protocol is a new enhanced feeding protocol. Twenty North American~     Intensive Care Units (ICUs) will assess baseline nutrition practices. Ten ICUs will be~     randomized to implement the PEP uP Protocol and educational intervention, and ten will be~     randomized to continue usual care. Nutrition practices will be reevaluated 6 months after~     baseline. The investigators hypothesize that the PEP uP Protocol will increase delivery of~     nutrition, and may ultimately lead to improved survival of critical illness.~   "
183145|NCT01167582|"~     The purpose of this study is to evaluate two approaches to red blood cell transfusion in~     anemic patients with acute coronary syndrome.~   "
183146|NCT01167569|"~     It has been shown that the stress that occurs during cardiac surgery leads to early decrease~     of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to~     complications after surgery.~      This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the~     outcome and complications after cardiac surgery.~   "
183147|NCT01167556|"~     Cannabis use by people with schizophrenia is associated with family distress and poor~     clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to help~     parents to motivate their child with a diagnoses of recent-onset schizophrenia to reduce~     cannabis use.~      In a single-blind randomised clinical trail with 75 patients with the diagnosis of~     schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will be~     conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that FMI~     will be more effective than routine care in reducing (a) cannabis use in patients and (b)~     distress and sense of burden in parents.~   "
183148|NCT01167543|"~     This study investigates the prevalence and pathophysiology of dental and periodontal~     involvement in pediatric patients with symptomatic or asymptomatic gastroesophageal reflux~     (GER) or gastroesophageal reflux disease (GERD). Primary objectives are to compare the~     prevalence of oral disease in children with and without a diagnosis or symptoms/signs of GERD~     in a cross-sectional study. Secondary objectives are to examine factors that might lead to~     the pathogenesis of the dental and periodontal lesions observed in this group of subjects.~      The primary hypothesis is to prove that children aged 10-18 years diagnosed with or having~     symptoms or signs of GERD have a significantly higher amount of dental erosions in comparison~     to a matched control group.~      Secondary hypotheses are that children aged 10 - 18 years diagnosed with or having signs of~     GER have higher DMFS (Decayed, Missing, Filled permanent tooth Surfaces) rates, higher SBI~     (Sulcus Bleeding Index) rates, worse Periodontal status, and lower saliva buffering capacity.~   "
183160|NCT01167387|"~     Postoperative infectious morbidity remain the most frequent, threatening and costly event~     after major surgery. Maintenance of postoperative euglycemia might be a key factor to prevent~     such complications and given the preliminary data on the positive effect of carbohydrate load~     on glucose metabolism it might also be valuable in improving outcome. If this treatment will~     be proved effective on relevant outcome measure such as rate of infections, it might be used~     routinely and extensively because preoperative carbohydrates administration is cheap, simple~     and applicable by everyone in any surgical ward.~      The aim of the trial is to evaluate if the normalization of blood glucose by means of~     preoperative oral administration of maltodextrine, in patients candidate to elective major~     surgery, may be effective in improve surgical morbidity.~   "
183149|NCT01167530|"~     The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung~     cancer.~      First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one~     week before then during the radiotherapy and will be continued for 3.5 weeks after the end of~     the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three~     patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of~     the study:RAD001 (everolimus) will be administered per os every day one week before then~     during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy.~     Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are~     planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be~     conducted independently and in parallel.Radiotherapy: 66 Grays over 6.5 weeks. (5 weekly~     fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100 mg/m2 D1, Navelbine 25 mg/m2 D1,~     D8, every 21 days.~   "
183150|NCT01167517|"~     This study will test the effectiveness of breast milk expression discharge instructions in~     digital video disc (DVD) format for home use by mothers of very low birth weight infants on~     the dose and duration of mother's breast milk feeding in their infants compared to breast~     milk expression discharge instructions in printed format. The investigators hypothesize that~     infants whose mothers receive breast milk expression discharge instructions via DVD will~     receive a larger dose of maternal breast milk and for longer duration during the initial~     neonatal intensive care unit hospitalization than infants whose mothers receive discharge~     instructions in printed format.~   "
183151|NCT01167504|"~     The aim of this study is to determine how different ingredients which are found in food and~     other consumer products affect the ability of saliva to form surface films.~      Saliva forms a protective film on the surfaces inside the mouth. This film affects the way we~     consume and digest food and protects our teeth and other surfaces inside the mouth from~     disease and decay. It is not well known how this film forms, or which components in everyday~     life affect formation of the film, and therefore its protective properties.~      Samples of saliva will be collected from apparently healthy volunteers. The properties of the~     film (thickness, density, strength, protein composition) will be studied in the laboratory~     under controlled conditions. The effects of common ingredients in foods and other products~     such as proteins, emulsifiers, preservatives and surfactants on the formation and properties~     of the film will be determined.~      The results of this study will help us to understand how different ingredients can change the~     properties of saliva that may affect the way that we sense and digest food, and the ability~     of saliva to protect against decay and infection. This could, in the future lead to new ideas~     for developing:healthy foods (e.g. lower fat) that taste better, or more effective dental~     care products.~   "
183152|NCT01167491|"~     The investigators recently showed an abnormal expansion of NK-like CD4+ T cells in Wegener's~     granulomatosis (WG), mainly in the diffuse vasculitis presentation. These cells expressed an~     assortment of activating NK cell receptors and their signaling partners, in particular DAP12.~     The investigators hypothesize that DAP12, or a downstream signaling target of DAP12, is the~     missing link between the different cell components involved in WG (neutrophils, macrophages,~     CD4 T cells).~   "
183153|NCT01167478|"~     The objective of this study is to verify if there is a neurophysiologic reserve when caffeine~     and placebo perceived as caffeine are manipulated in closed- and opened-loop exercises.~     Parameters of excitability level of skeletal muscle and Central Nervous System (CNS), and~     peripheral metabolism will be measured~   "
183154|NCT01167465|"~     The purpose of this clinical observation is to evaluate the safety and consumers'~     satisfaction of Moussik vs Desitin Creamy ointment as a diaper rash protection product.~   "
183155|NCT01167452|"~     This study will find how weight affects the dosing of a drug called sulfamethoxazole and~     trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives~     is the same regardless of the patient's weight. The entire cohort was analyzed for the study~     outcomes. BMI groups were for recruitment purposes only and were not used for ordinal data~     analysis.~      All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you~     will receive in this study will be referred to as study medication within this informed~     consent form. This drug is a combination of two antibiotics, sulfamethoxazole and~     trimethoprim, which belongs to a class of medication known as sulfones and is approved by~     the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial~     infections such as ear infections, urinary tract infections, bronchitis, traveler's diarrhea,~     and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given orally.~   "
183156|NCT01167439|"~     The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in~     order to identify the best candidates and the proper timing to perform dysphagia alleviating~     procedures in both heterozygote and homozygote patients from the large pool of cases with~     this disease in Israel.~   "
183157|NCT01167426|"~     This is an open-label, multicenter study conducted at approximately 20 sites. Each patient~     will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall~     injection satisfaction.~   "
183158|NCT01167413|"~     Fibromyalgia Syndrome (FMS) is a non - inflammatory condition characterized by the presence~     of chronic, widespread musculoskeletal pain and tenderness; FMS is considered to be the~     result of increased processing of pain by the central nervous system.~      Axial spondyloarthropathy is the hallmark of Ankylosing Spondylitis (AS), an inflammatory~     joint disease involving the axial spine, the sacroiliac joints as well as peripheral joints.~      Although FMS and AS differ vastly in their pathogenesis, a considerable clinical overlap may~     exist between these conditions. Both disorders typically cause chronic nocturnal back pain~     and disturbed sleep may accompany either condition. In addition,the investigators have~     previously described an increased prevalence of (secondary) FMS among female AS patients.~      This overlap may have important clinical implications since the presence of comorbid FMS may~     lead to increased severity results on commonly used instruments in the evaluation of disease~     activity in AS, such as the BASDAI and BASFI .~      Recently, the Assessment of Spondyloarthritis international Society (ASAS) has published~     updated classification criteria for axial spondyloarthropathy. These criteria, which are~     summarized in table 1, are based on the evaluation of patients suffering from chronic back~     pain with an age of onset of less than 45.~      Objective:~      The objective of the current study is to evaluate the prevalence of axial~     spondyloarthropathies among FMS patients, utilizing the new ASAS criteria.~   "
183161|NCT01167374|"~     Treatment options for patients with advanced hepatocellular carcinoma (HCC) are often~     limited. In most cases, they are not amenable to local therapies including surgery or~     radiofrequency ablation. The multi-kinase inhibitor sorafenib has shown to increase overall~     survival in this patient group for about 3 months.~      Radiation therapy is a treatment alternative, however, high local doses are required for~     long-term local control. However, due to the relatively low radiation tolerance of liver~     normal tissue, even using stereotactic techniques, delivery of sufficient doses for~     successful local tumor control has not be achieved to date.~      Carbon ions offer physical and biological characteristics. Due to their inverted dose profile~     and the high local dose deposition within the Bragg peak precise dose application and sparing~     of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an~     increased relative biological effectiveness (RBE), which can be calculated between 2 and 3~     depending on the HCC cell line as well as the endpoint analyzed.~      Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for~     patients with HCC.~      In the current Phase I-PROMETHEUS-01-Study, carbon ion radiotherapy will be evaluated for~     patients with advanced HCC. The study will be performed as a dose-escalation study evaluating~     the optimal carbon ion dose with respect to toxicity and tumor control.~      Primary endpoint is toxicity, secondary endpoint is progression-free survival and response.~   "
183162|NCT01167361|"~     This study aims to prospectively estimate the incidence of Respiratory virus (RV) infections~     in children with symptoms of an upper respiratory tract infection (URTI) or lower respiratory~     tract infection (LRTI) at St. Jude Children's Research Hospital (SJCRH) using the FilmArrayTM~     System, a novel highly sensitive and rapid assay for RV detection. An aliquot from the~     leftover sample remaining after clinical diagnostic testing will be used for FilmArrayTM~     analysis. Patients will be accrued on the study over a one year period.~   "
183163|NCT01167348|"~     The purpose of this study is to examine whether auricular acupressure is effective in~     reducing body weight, waist circumference, or lipid profile.~   "
183164|NCT01167335|"~     This study will assess the efficacy of BGG492 as adjunctive treatment in patients with~     refractory partial onset seizures~   "
183165|NCT01167322|"~     The aim of the present Phase III study is to assess the positive predictive value of NPC-07~     (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and~     pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight,~     3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent~     malignant glioma (WHO grades III/IV).~      Positive predictive value will be confirmed by percentage of patients showing positive tumor~     cell identification in all biopsies taken from areas of strong and weak fluorescence. This~     study will be divided into two stages. After reviewing of the result of safety and~     pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring~     committee, more subjects will receive NPC-07 in Step II.~   "
183166|NCT01167309|"~     The purpose of this trial is to determine the safety and tolerability of ascending single and~     multiple oral doses of LEO 27847 in secondary hyperparathyroidism patients.~   "
183167|NCT01167296|"~     To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if~     leaving it in the uterus will cause uterine infection.~   "
183168|NCT01167283|"~     This study was designed to test the following hypothesis:~      To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type~     distribution.~   "
183169|NCT01167270|"~     This study will test an intervention program designed to provide developmentally appropriate~     guidance to parents of infants on responsive parenting and healthy lifestyle to see if that~     intervention will prevent rapid weight gain in infancy and overweight at age 3 years.~     Further, compared with control infants, intervention infants will have lower body mass index~     (BMI) percentiles at age 3. The investigators also hypothesize that control infants will gain~     weight more rapidly over time.~   "
183170|NCT01167257|"~     Overactive bladder (OAB) is a bothered symptom syndrome. Traditional medication for OAB is~     antimuscarinic agent. However, adverse events such as dry mouth, constipation, blurred~     vision, and dizziness may prohibit patient to take this drug for OAB. Intravesical botulinum~     toxin A (BoNT-A) is a novel treatment however, BoNT-A can cause acute urinary retention and~     large postvoid residual. In this grant we will evaluate liquid liposome delivery of BoNT-A~     (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided~     needle injection for refractory OAB.~   "
183171|NCT01167244|"~     The purpose of this study is to observe an improvement in overall response rate in NSCLC~     subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR~     mutation positive or who have had a prior a response.~   "
183172|NCT01167231|"~     The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been~     associated with a significant reduction of cardiovascular events. Additionally, acarbose has~     been shown to have a beneficial influence on some of the other cardiovascular risk factors~     (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose~     may be a promising therapeutic strategy for reducing the increased risk for cardiovascular~     disease. Further studies are needed to confirm the influence of acarbose on cardiovascular~     risk factors in the real life setting.~   "
183173|NCT01167218|"~     The purpose of this study is to conduct a Verify now assay to detect platelet aggregation~     defects in patients with Myelodysplastic syndrome(MDS), immune thrombocytopenia purpura (ITP)~     and myeloproliferative disorders (MPD).~   "
183174|NCT01167205|"~     The purpose of this study is to determine whether astaxanthin (ASX) supplementation will~     reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese~     adults.~   "
183175|NCT01167192|"~     The purpose of this study is to determine whether platinum-based chemotherapy (either~     cisplatin or carboplatin), when given with radiation therapy prior to surgery, is effective~     in improving response to treatment in triple negative breast cancer patients. This treatment~     is being studied in this type of breast cancer because it does not respond well to commonly~     used treatments such as tamoxifen or herceptin.~   "
183176|NCT01167179|"~     The purpose of this study is to conduct an early evaluation of a nurse-led follow up~     intervention added to the usual medically oriented follow up care. Besides evaluating the~     feasibility and acceptability to patients, the effect on psychosocial adjustment and quality~     of life of patients is determined.~   "
183177|NCT01167166|"~     For patients with leukemia who have not responded to or have progressed after an initial~     response to standard therapy, therapeutic options are limited. Although responses to standard~     regimens do occur, durable remissions are achieved infrequently and current regimens are not~     curative in the majority of patients. Identification of active agents in patients with~     relapsed Acute Myeloid Leukemia (AML) ultimately affords the potential for use upfront as a~     component of induction regimens that may translate to improved outcome. Therefore,~     development of new agents is of critical importance. This study will look at a new,~     investigational agent, ON 01910.Na, to determine if it has the potential to help Patients~     with AML and Acute Lymphocytic Leukemia (ALL) and transformed Myeloproliferative Neoplasms.~   "
183178|NCT01167153|"~     The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine~     (EXforge®) with nifedipine, as well as vascular function index.~   "
183179|NCT01167140|"~     This is a prospective, non-randomized study to evaluate the performance of the MyoScience~     Cryo-Touch II device for the treatment of wrinkles.~   "
183180|NCT01167127|"~     The main objective of the study is to observe the OXN treatment of patients with moderate to~     severe non-malignant pain in daily clinical practise with respect to pain relief and bowel~     function. Patients who have insufficient pain relief and/or unacceptable side effects with~     the previous analgesic treatment WHO step 1 or 2 and require around-the-clock opioid therapy~     can be included in the study.~   "
183181|NCT01167114|"~     In this research study, the investigators are looking to see how effective STA-9090 is in~     treating esophagogastric cancer. The investigators will also evaluate the side effects of~     STA-9090, and examine the relationship between the presence of HSP-90 and how well study~     participants respond to STA-9090. STA-9090 works by blocking a protein in tumor cells called~     HSP90, which is thought to play a role in tumor growth. By interfering with this protein's~     function, STA-9090 may help kill tumor cells. This drug has been used in other research~     studies and information from those other research studies suggests that this agent may help~     to slow tumor growth in esophagogastric cancer.~   "
183182|NCT01167101|"~     Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet~     conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good~     effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized~     controlled study to assess the effect of a combination therapy of rebamipide and proton pump~     inhibitor (PPI) on post ESD ulcer healing.~   "
183183|NCT01167088|"~     The purpose of this study is to investigate whether a new medicine, called mitoquinone, will~     reduce raised liver enzymes due to NAFLD and to see if it is safe.~   "
183184|NCT01167075|"~     The aim of the study is to assess the efficacy and tolerability of the low-volume supplement.~     The investigators randomized critically ill patients to receive Intestamin plus Fresubin or~     Fresubin alone.~   "
183185|NCT01167062|"~     This is a randomized double blind placebo-controlled study that will assess the efficacy of~     Tamsulosin oral-controlled absorption system (OCAS) 0.4 mg in the conjunctive medical~     treatment of distal ureteral stones with a size of 4-10 mm compared to placebo in control~     group.~   "
183186|NCT01167049|"~     To investigate the efficacy of capecitabine combined with paclitaxel as neoadjuvant~     chemotherapy for gastric cancer with liver metastasis only~   "
183187|NCT01167036|"~     The purpose of this study was to determine if using a specialized massage tool was more~     effective than a placebo treatment in relieving pain in the upper trapezius muscle along the~     top of the shoulder.~   "
183188|NCT01167023|"~     The purpose of this trial is to assess the safety of Prasugrel in adult patients with sickle~     cell disease (SCD) by monitoring the rate and severity of hemorrhagic events requiring~     medical intervention compared to placebo for 30 days.~   "
183189|NCT01167010|"~     The primary objective will be to compare the Eurofarma and Alenia formulations regarding~     their impact on the pulmonary function of mild to moderate persistent asthma patients and the~     secondary objective will be to compare the three study formulations regarding the clinical~     control of the symptoms and the patients' compliance to the treatment.~   "
183190|NCT01166997|"~     The ULTIMA study is intended to prove that in patients with pulmonary embolism and a right~     ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1 (RV/LV~     ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-PA) as~     compared to unfractionated heparin anticoagulation. Specifically, at 24 hours the RV/LV ratio~     will be significantly reduced in the treatment arm compared to the control arm.~   "
183191|NCT01166984|"~     The primary objective of this study is to establish the safety profile and maximum tolerated~     dose of AB103 given as a single intravenous infusion or by repeated (5 days) IV infusions in~     healthy volunteers.~   "
183192|NCT01166971|"~     The purpose of this study is to prospectively evaluate postoperative visual and refractive~     parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3~     versus those bilaterally implanted with the Tecnis Multifocal 1-piece.~   "
183193|NCT01166958|"~     Current osteoporosis therapies produce a prompt increase in bone mass, followed by only~     modest or no further subsequent gains. This limitation, known as the remodeling transient,~     reflects the coupling of bone resorption with formation such that interventions impacting~     either of these processes lead to compensatory changes of the other. For example, medications~     which increase bone formation promptly also stimulate bone resorption. Thus, given the need~     to dramatically increase bone mass in patients with osteoporosis, it is necessary to~     uncouple formation and resorption. The investigators believe this to be possible using~     currently existing FDA-approved therapeutic agents, by using a novel, sequential approach.~      This pilot project will obtain preliminary data essential to support future work. In this~     study, the investigators will begin to explore the use of sequential anabolic treatment with~     teriparatide followed by antiresorptive therapy with raloxifene. The investigators propose~     that such sequential treatment will allow opening of the anabolic window, the brief period~     of time following initiation of teriparatide therapy in which bone formation exceeds~     resorption.~   "
183194|NCT01166945|"~     The investigators objective is to compare short course (5 days) to long course (14~     days)antibiotics for the treatment of acute bacterial sinusitis in children. The~     investigators hypothesize that short course therapy will lead to more frequent relapses of~     sinusitis and will not reduce resistant organisms.~   "
183195|NCT01166932|"~     Objective: To compare the clinical effectiveness and hospital costs, the initial empirical~     treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community~     Acquired Pneumonia (CAP) severe.~      Methods: Clinical prospective randomized study in children aged two months to five years of~     age with a diagnosis of severe CAP, according to criteria of World Health Organization (WHO),~     admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu- UNESP. We~     excluded children with comorbid disorders (primary and secondary immunodeficiency) with acute~     or chronic kidney disease, referred patients receiving antibiotics proposal and history of~     allergy to antibiotics proposed. We included 104 children who were randomized into two groups~     to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin / Clavulanate IV (GAA, n~     = 56). Patients of the GAA, after clinical improvement, has been receiving the same oral~     antibiotic, and maintaining clinical stability, were discharged from hospital, the GOC~     received any IV treatment. The outcomes analyzed were time to clinical improvement (fever and~     tachypnea), duration of oxygen therapy, hospitalization time, need to expand the~     antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and hospital costs.~     Treatment failure was determined by the need to expand the antimicrobial spectrum after 48~     hours of hospitalization.~   "
183196|NCT01166919|"~     Port wine stain, also called nevus flammeus, is a congenital, cutaneous vascular malformation~     involving post-capillary venules which produces a light pink to red to dark-red-violet~     discoloration of the skin. It is estimated that Port wine stain occurs in 3 children per~     1,000 live births. Approximately 900,000 individuals in the United States and twenty million~     people worldwide have Port wine stain birthmarks .~   "
183197|NCT01166906|"~     There is a gating mechanism in the dorsal horn of the spinal cord that acts to facilitate or~     inhibit transmission of pain signals to the brain. The gate can be closed by mechanical~     stimuli such as touch and vibration.~   "
183198|NCT01166893|"~     According to the National Burn Repository 2007, the most common type of burn injury is a~     partial thickness burns. The current standard of care for partial thickness burns is two~     weeks of topical therapy and wound care. Burns that do not heal within two weeks undergo~     surgical excision and skin grafting.~   "
183199|NCT01166880|"~     The researcher want to know whether reflections of light can be used to provide real-time~     pictures of blood vessel formation around infants' heads. This approach is called laser~     speckle imaging~   "
183200|NCT01166867|"~     The researcher want to use video signals to monitor heart rate, respiration rate and oxygen~     saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method:~     periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured using~     light.~   "
183201|NCT01166854|"~     The researcher wants to explore the genetic causes of muscle disease. The researcher is~     particularly interested in muscle disorders that occur in combination with diseases of bone~     that appear to be passed on from generation to generation.~      Diffuse Optical Spectroscopy will measure the concentrations of blood, water, and lipids~     (fats, for example) in your tissues. This device essentially measures the color of tissues in~     order to determine tissue physiology (its physical and chemical processes).~   "
183202|NCT01166841|"~     The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to~     allow access to the heart through a small incision in the right chest. This avoids the use of~     a sternotomy incision through the bone in the front of the chest. The benefits of such an~     approach are cosmetic (smaller incision not easily visible) and faster recovery. The~     minimally invasive approach also eliminates the risk of sternal wound infection. Minimally~     invasive cardiac surgery however poses additional challenges; one of the biggest is access to~     the large blood vessels which need to be cannulated to allow the heart lung machine to~     function. In conventional surgery, these vessels are easily accessed as they are entering or~     leaving the heart. In minimally invasive surgery, the cannula are placed into easily~     accessible arteries and veins, traditionally the femoral vessels. These vessels are smaller~     than those by the heart and so require smaller cannula, which provide challenges to the heart~     lung machine. One way around this is to use more cannulae and so cannulation of a vein in the~     neck is also performed. This cannula however, has been associated with neck hematoma, tearing~     of the vein and blood loss. While placement of the cannula in the neck is routine at LHSC~     now, when this surgery was first performed here 10 years ago, it was done so without the neck~     cannula and with no injury to patients. The purpose of this study therefore, is to more~     rigorously study the effect of the neck cannula on heart lung bypass, and more specifically~     to see if oxygen delivery to the organs, and the brain in particular is sufficient to avoid~     hypoxia.~   "
183203|NCT01166828|"~     NRI research focuses on nursing interventions that are patient-centered, culturally~     congruent, cost-effective and outcome-driven. High priority populations of interest are~     veterans with Spinal Cord Injuries (SCI). The development of innovative tele home techniques~     for preventing pressure ulcers in veterans with SCI is of high importance in the VA. Our~     findings may provide clinicians with improved methods for skin and wound assessment and more~     effective and efficient PUP strategies for Hispanic and non Hispanic veterans. The new model~     for primary care, the patient-centered Medical Home provides an exciting change in the VA~     that can benefit from the proposed project.~   "
183204|NCT01166815|"~     Zinc deficiency is prevalent in children in developing countries. Zinc-supplementation is~     proven to reduce the duration and severity of childhood diarrhea in randomized controlled~     trials. However, despite this evidence, its efficacy to reduce diarrhea morbidity in adults~     remains unknown. The main objective of this study is to determine the efficacy of~     Zn-supplementation on diarrhea incidences in a vulnerable adult population. The study will be~     carried out in Kombewa division, Kisumu District and will involve 500 adults aged 18-55~     years. They will be randomly assigned to receive Zn supplement (or placebo) on a daily basis~     over a 3 month period. Morbidity information will be collected daily for 4 months, while~     anthropometric measures and laboratory data will be obtained at study onset, end of~     supplementation and study conclusion. In addition, HIV and malaria tests will be carried out~     during the study as they are important confounders. The significant differences in diarrhea~     incidence between the Zn-group and the placebo-group will be determined using SPSS. The~     results are expected to provide the scientific basis and common pathway for development of an~     anti-diarrheal supplement for vulnerable populations such as environmental refugees, deprived~     and displaced persons, and troops prior to deployment.~   "
183208|NCT01166763|"~     The overall goal of this project is to determine if high dose vitamin D3 given to~     premenopausal women at high risk for development of breast cancer, who initially have~     insufficient levels of 25-hydroxy vitamin D (<30 ng/ml), will raise 25(OH)D levels above 50~     ng/ml. If so, will certain risk biomarkers for development of breast cancer be reliably and~     favorably modulated?~   "
183209|NCT01166750|"~     This study is a randomized wait-list controlled trial with repeated measures. There will be~     two groups: (1) standard medical care (wait-list control), and (2) standard medical care plus~     the adjunctive Jointstrong pain coping skills CD-ROM program (treatment). The study will have~     four phases: Pre-intervention Baseline (2 weeks); Intervention (4 weeks); immediate~     post-intervention follow up (2 weeks); and 12-week post-intervention follow up (2 weeks). The~     purpose of this study is to determine if using a CD-ROM program for juvenile arthritis can~     help children learn how to improve their symptoms on their own and reduce the frequency of~     symptoms.~   "
183210|NCT01166737|"~     It is still not clear whether a positive AGO-score just selects patients with less aggressive~     biologic tumor behavior who as well would have had a positive outcome by chemotherapy only,~     or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the~     AGO-score was confirmed to select patients with a less than 30% risk of ending with residual~     tumor after surgery for recurrent disease. This could avoid including patients into the~     present surgical protocol who could not benefit from an operationThe goal of this third~     DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether~     maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy~     can improve overall survival as compared to platinum based combination chemotherapy alone in~     AGO-score positive patients.~   "
183211|NCT01166724|"~     The investigators hypothesize that Tacrolimus (Tac) withdrawal from a Tac, MMF and steroid~     based triple therapy regimen leads to long term improved/stabilized graft function~     (glomerular filtration rate, GFR) primarily as a consequence of halting CNI-induced~     fibrogenetic processes that mediate loss of functioning renal tissue. The investigators~     further hypothesize that the underlying fibrotic mechanism is mediated by pathophysiologic~     processes that promote epithelial to mesenchymal transition (EMT) (mediated by TGF- ƒÒ) and~     that early therapeutic intervention may reverse this process (mediated by BMP-7)4.~      To address these hypotheses the investigators propose the following clinical and mechanistic~     aims:~      The investigators will test the hypothesis that switching from Tac to SRL in a Tac based~     triple therapy regimen with MMF and steroids in living and or deceased donor renal transplant~     recipients leads to improvement in allograft structure and function at 2 years~     post-transplantation.~      The investigators will test this hypothesis in an open label controlled trial where stable~     renal allograft recipients on Tac, MMF, prednisone maintenance immunosuppression will undergo~     renal biopsy at 3-4 months post-transplantation and will be randomized to either a) Remain on~     Tac, MMF and prednisone (CNI-maintenance) or b) switch the Tac to SRL and continue MMF and~     prednisone. The investigators will then compare biopsy derived measures of allograft fibrosis~     (CADI, Sirius Red, Banff Chronicity Index) and GFR in the two groups~   "
183212|NCT01166711|"~     The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent~     Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium~     Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please~     (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.~   "
183213|NCT01166698|"~     The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled~     administration of single and multiple increasing doses, and to estimate the maximum dose that~     is tolerated in healthy people.~   "
183214|NCT01166685|"~     Background:~      Retrospective analyses of long-term BASKET findings identified patients with large~     drug-eluting stents (DES) (>2.5mm Stents) as patients at risk for late cardiac death/nonfatal~     myocardial infarction. In view of new DES with absorbable polymers and new bare metal stents~     BMS) with thin struts and biocompatible polymers, BP-II will be launched to test their~     comparative clinical safety up to 12 years if treated with an aspirin/prasugrel combination,~     since prasugrel halved stent thrombosis rates compared to clopidogrel in a large ACS trial.~      The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to~     the Xience Prime DES stent on safety and e cacy in patients requiring stents >=3.0mm in~     diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel~     and aspirin~      Set-up:~      Multicenter open-label randomized trial.~      Patient inclusion:~      Unselected series of patients in need of large (>3mm) stents only in native vessels~     irrespective of clinical indication.~      Patient exclusion:~      In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery <12months,~     increased bleeding risk, no compliance expected, History of stroke or transient ischemic~     attack (TIA).~      Randomization:~      By centre using sealed envelopes 1:1:1: Nobori:Xience Prime:Prokinetik-stent.~   "
183215|NCT01166672|"~     The purpose of this study is to establish feasiblity of recruiting obese breast cancer~     survivors at the end of treatment, getting those survivors to lose weight and attend~     follow-up visits for 6 months.~   "
183216|NCT01166659|"~     The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation~     as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary~     open angle glaucoma (POAG) who have failed at least one class of topical medical therapy~   "
183217|NCT01166646|"~     The purpose of this study is to determine whether the investigational lotion is an effective~     treatment of moderate to severe plaque psoriasis in comparison to an approved cream.~   "
183218|NCT01166633|"~     Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely~     leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive~     monitoring is required.~   "
183219|NCT01166620|"~     To quantify the incremental cost of infections in patients treated with etanercept,~     adalimumab or infliximab versus abatacept.~   "
183329|NCT01165177|"~     The purpose of this observer-blind study is to evaluate the efficacy, safety and~     immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50~     years.~      Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted~     concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both~     studies combined will be conducted contingent on each study achieving its objectives. The~     protocol posting of study ZOSTER-022 also deals with the outcome measures related to the~     pooled analysis.~   "
183220|NCT01166594|"~     When a patient with glaucoma who has a pressure that is too high and causing damage to their~     vision, despite receiving the maximum amount of medication that can be tolerated, the~     decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma~     surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in~     the eye and partially covered with a flap of tissue. This new opening allows fluid to drain~     out of the eye bypassing the clogged drainage channels that are malfunctioning in patients~     with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and~     lowers eye pressure.~      However, many people need another trabeculectomy or other glaucoma surgery because the~     surgery may fail either early or much later because the body closes the drain created by the~     surgeon. The surgery is also less likely to work in patients with darker pigmentation,~     children who have congenital glaucoma, people with difficult to control glaucoma with new~     blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result,~     the investigators need to find ways to improve the longterm survival of trabeculectomy~     surgery in all patients.~   "
183221|NCT01166581|"~     The primary goal of this study is to determine if preoperative breast MRI findings resulted~     in more extensive surgery, i.e., mastectomy than breast conserving surgery, i.e., lumpectomy~     in early stage breast cancers at Summa Akron City Hospital. Early stage breast cancer is~     defined as breast tumor size less than 5 cm.~      The objectives are to:~        -  Review early stage breast cancer patient cases treated at Summa Akron City Hospital~          between 2006 and 2009 to evaluate clinical and pathological staging~        -  Determine the results of preoperative breast MRI and the impact on type of surgery~          performed~        -  Evaluate the decision to have mastectomy rather than lumpectomy, i.e., physician or~          patient decision and if this decision was based on breast MRI findings~   "
183222|NCT01166568|"~     Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision~     in patients who require reading glasses.~   "
183223|NCT01166555|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921~     administered as a single subcutaneous dose in healthy volunteers.~   "
183224|NCT01166542|"~     The purpose of this Phase 3 study is to evaluate overall survival and progression free~     survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in~     combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients~     with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.~   "
183225|NCT01166529|"~     Celiac plexus neurolysis (CPN) has been performed for nearly 100 years to alleviate the~     abdominal pain associated with pancreatic malignancy and other conditions, and is usually~     undertaken at a late stage in the disease process, when analgesic options have been largely~     exhausted or have led to significant and often unacceptable side effects. Until recently, CPN~     was most commonly performed under radiographic guidance; however, in the last 10 years, CPN~     has been routinely performed under endoscopic ultrasound (EUS) guidance. Several case series~     have demonstrated the efficacy and safety of this technique when used to treat the pain~     associated with pancreatic malignancy and/or chronic pancreatitis. However, the efficacy of~     EUS-guided CPN in the treatment of pain related to non-pancreatic malignancies has yet to be~     described. The goal of this study is to assess the efficacy of EUS-guided CPN in the~     management of pain in patients with abdominal non-pancreatic malignancies. Our hypothesis is~     that EUS-guided CPN will provide adequate pain relief in these patients.~   "
183226|NCT01166516|"~     Study to collect post-market safety data for HUD IBV Valve System, a device to control~     prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged~     air leaks following lobectomy, segmentectomy, or LVRS. An air leak present on post-operative~     day 7 is considered prolonged unless present only during forced exhalation or cough. An air~     leak present on day 5 should be considered for treatment if it is: 1)continuous, 2) present~     during normal inhalation phase of inspiration, or 3) present upon normal expiration and~     accompanied by subcutaneous emphysema or respiratory compromise.~   "
183227|NCT01166503|"~     The goal of this study is to determine whether corrective surgery done earlier than the~     current standard can better improve the visual and eye movement deficits in children with~     infantile esotropia (crossed eyes in infancy).~   "
183228|NCT01166490|"~     This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and~     tolerability of ASG-5ME and identify the maximum tolerated dose in patients with~     pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and~     tolerability in patients with relapsed or refractory gastric adenocarcinoma.~   "
183229|NCT01166477|"~     The Study will help to compare the Quality of Life for those HIV patients that are on~     monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitor~   "
183230|NCT01166464|"~     The primary goal of this study is to use qualitative interviews and focus groups to aid us in~     adapting a face-to-face smoking cessation intervention for delivery through text messaging.~     After design is completed, the intervention will be pilot tested with a sample of young~     adults (ages 18-35) who smoke. Final assessments will be conducted at 7 weeks (end of~     treatment) and both 3 and 6 month follow up.~   "
183231|NCT01166451|"~     The purpose of this clinical trial was to determine if high-iron or low-iron formula,~     containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron~     status in infancy and on development longitudinally.~   "
183243|NCT01166295|"~     Post herpetic neuralgia (PHN) is an undertreated condition. It is a type of neuropathic pain~     (NP), or pain caused by abnormal activity of sensory nerves. Its mechanisms are not fully~     understood, and medication trials for PHN pain and other types of NP are frequently~     unsuccessful.~      There has been extensive investigation aimed at identifying and understanding the specific~     mechanisms of NP. While some of these tests are inexpensive and easy to perform at the~     bedside, many require expensive tools and highly equipped laboratory facilities. Further,~     there is no standard method for assessment of pain in NP patients.~      The investigators aim to test a Bedside Sensory Testing Kit (assessment for Neuropathic Pain)~     on a small number of patients with PHN.~      The purpose of the Kit is to identify mechanisms of pain. The goal of this research is to~     design a way to classify patients with PHN based on what mechanisms are causing their pain,~     since this may help predict the best medications for individual patients.~   "
183330|NCT01165164|"~     The purpose of this study is to describe the night-time use of an investigational lubricant~     eye drop.~   "
183232|NCT01166438|"~     Urinary incontinence is a prevalent condition that markedly impacts quality of life and~     disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of~     urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence~     (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB~     symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the~     use of anticholinergic medications. These treatment modalities may not result in total~     continence and often drug therapy is discontinued because of lack of efficacy, side effects~     and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle~     exercises require consistent, active intervention by the patient which is often not~     sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to~     determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more~     effective than a standardized regimen of oral anticholinergics in reducing urge urinary~     incontinence. The null hypothesis is that there is no difference in the change from baseline~     in average number of urge urinary incontinence episodes over 6 months between groups.~   "
183233|NCT01166425|"~     Study Design This is the second study of a multiphase, multicenter trial that will~     comprehensively examine lithium in the treatment of pediatric participants with bipolar I~     disorder. In order to examine the treatment of bipolar disorder with lithium, this study will~     include four phases of treatment. The first phase, the Efficacy Phase, will include~     participants being randomized to either lithium or placebo for 8 weeks to determine the~     efficacy of lithium in the treatment of children and adolescents with bipolar I disorder.~     Once participants complete the Efficacy Phase, participants may be eligible to continue in~     the Long- Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment.~     Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase~     will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase,~     participants will be randomized to either placebo or lithium treatment for up to 28 weeks.~     Finally, those participants who experience a mood relapse during the Discontinuation Phase~     will be enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8~     weeks.~   "
183234|NCT01166412|"~     WHAT IS THE STUDY PRODUCT? The study product is a contraceptive patch, which has the study~     drug on the patch. The patch is applied directly to the skin and it contains Levonorgestrel~     (LNG) in a time-release form. LNG is a hormone that has been tested and been approved by the~     Food & Drug Administration (FDA) in other forms, for example: contraceptive pills,~     intrauterine devices (IUDs, which are put in the uterus (womb)) and implants (drug in silicon~     tubing placed under the skin). The use of LNG in the form of a contraceptive patch makes this~     an experimental drug because the way the drug will be absorbed in the body is a new~     technique. This study drug does not contain estrogen and it does not protect against HIV,~     AIDS, or any other sexually transmitted diseases (STDs).~      LNG is a progestin (a type of drug that is like a hormone. Progestins can cause changes at~     the opening of the uterus (womb), such as thickening of the cervical mucus (fluid). This~     thickened cervical mucus makes it difficult for the male's sperm to reach and fertilize the~     woman's egg. Since LNG is being absorbed through your skin from the patch, it is~     experimental, and it is unknown if this study product will really prevent pregnancy like~     other progestins.~      WHY IS THIS STUDY BEING DONE?~      The purpose of this study is to find out:~        -  How well the patch prevents pregnancy~        -  How safe the patch is to use every day~        -  How much study drug needs to be in the patch to make sure that it prevents pregnancy~        -  How the study drug in the patch affects cervical mucus (fluids)~        -  How the study drug in the patch affects your rate of ovulation (how often you release an~          egg)~        -  How well the patch sticks to your skin, without falling off, for a week at a time~        -  Whether the patch causes any skin irritation or rash (redness or itchiness)~        -  Whether the study drug in the patch affects your everyday life and if it causes any side~          effects.~      WHAT DOES THE STUDY INVOLVE? We expect that there will be approximately twenty (20) women at~     each of the six (6) participating clinics in the study. In total, there will be about 120~     women from all over the United States who will be in this study. This study is comparing the~     effectiveness of two different doses of the study drug (40ug and 75 ug) in the patches. This~     study is an open-label randomized trial, meaning that you and your study doctor will be aware~     of the dosage of study drug that you will be given. Randomization means that you will be~     selected by chance, like tossing a coin or rolling a dice. You have a 50% chance of being in~     the group that receives the 40ug dose patch or the group that receives 75ug dose patch.~   "
183235|NCT01166399|"~     The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12~     and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks~     postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Symptoms~     of FI will be defined by at least monthly symptoms of leakage of liquid, solid stool, and~     mucus. Flatal incontinence will be assessed at 24 weeks, based on the Fecal Incontinence~     Severity Index, and fecal urgency will be assessed at 24 weeks based on the one question from~     the Modified Manchester questionnaire. A sample size of approximately 400-450 subjects will~     be enrolled.~   "
183236|NCT01166386|"~     More than 1.4 million people a year in the United States begin confronting life with the~     medical, cognitive, and psychosocial challenges resulting from traumatic brain injury (TBI).~     A range of cognitive impairments commonly observed following injury increase caregiver burden~     as well as per-person lifetime costs for care and support of survivors of TBI, estimated at~     $600,000 to $1,875,000. Our long-term goal is to lessen these burdens through improving the~     functional status of patients with TBI by providing an evidence-based, comprehensive, brief,~     acute-care intervention, First Steps Acute Neurobehavioral and Cognitive Intervention~     (FANCI). The 10-sesson, manualized FANCI Program will be tested in a controlled, randomized~     study. Therapeutic components of the FANCI include didactics, cognitive remediation,~     demonstration, guided self-reflection, rehearsal, and supported practice of skills and~     strategies. Specific hypotheses are that 1) FANCI will result in more improvement in~     functional status compared to standard interdisciplinary rehabilitation treatment and 2)~     FANCI will result in more improvement on measures of neurobehavioral functioning compared to~     standard rehabilitation care for patients with moderate to severe TBI. We base these~     hypotheses on the observations that 1) providing information about symptoms, treatment, and~     coping results in reduced symptom intensity and duration for patients with TBI, and 2)~     inpatient participants in recent FANCI pilot studies learned >80% of the FANCI Program~     curriculum, and 3) the most recent pilot study participants had significantly better~     functional outcomes at discharge than matched controls. The specific aims of the proposed~     study are to 1) evaluate the efficacy of FANCI for improving functional status following~     treatment using the FIM, 2) examine the impact of FANCI on broader outcome measures of~     general emotional and behavioral functioning and productive activity in the community as~     measured post-treatment and at 6-month follow-up, 3) examine contributions of participant~     injury severity and cognitive status at time of treatment to treatment outcome and treatment~     response, 4) examine contributions of treatment variables of session topic and mastery,~     caregiver presence, and concurrent therapies on treatment outcome and treatment response for~     inpatients with TBI. Primary outcome measure is the (FIM). We will secondarily compare scores~     on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE), Rehabilitation~     Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale (FRsBe). Our design is~     a parallel groups, single-blind, randomized, controlled trial. We will enroll 150 (75~     treatment, 75 control) participants. Inclusion Criteria: Mod to Sev TBI based on time to~     commands, English speaker, Length of stay ≥ 5 days in acute BI rehabilitation Unit, 18 years~     of age or older, ≥ 79 on GOAT.~   "
183244|NCT01166282|"~     The purpose of this study is to evaluate the efficacy and safety of adalimumab given~     subcutaneously every other week (eow) as compared to placebo in pediatric subjects with~     Enthesitis Related Arthritis (ERA).~   "
183331|NCT01165151|"~     The present study will assess whether the size of treatment groups (groups of 10 vs. 30~     participants) affects short- and long-term weight loss. It is hypothesized that participants~     assigned to a small group will exhibit similar short-term and long-term weight losses (i.e.,~     weight loss at months 6 and 12) as compared to those assigned to a large group.~   "
183237|NCT01166373|"~     Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for~     OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study~     and no new study treatment interventions will be given. Rather an enrollment intervention~     will be investigated with potential E-OPTIMAL participants randomly assigned to watch a~     standardized video prior to consent or undergo the standard informed consent process. The~     standardized video will review the rationale for women's health research, the importance of~     long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has~     undergone review by potential subjects, coordinators and physician researchers to ensure that~     the relevance and importance of issues potentially impacting on long-term participation in~     studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three~     additional years. Women will be strongly encouraged to participate in annual examinations and~     annual telephone surveys but may participate in only one of these study parts if needed.~      We propose to test the following null hypotheses:~        1. There will be no difference in time to surgical failure between uterosacral vaginal~          vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years~          after surgery.~        2. The addition of a standardized video detailing the importance of long-term follow-up~          studies for POP to the informed consent process will not improve enrollment or retention~          in E-OPTIMAL.~   "
183238|NCT01166360|"~     Growth determination factor 15 (GDF-15) and high sensitive troponin-t (hsTnT) are emerging~     humoral markers for risk stratification in clinically stable heart failure patients and in~     patients with stable coronary artery disease. No data are available about the prognostic~     value of these peptides in relation to mortality and morbidity in patients undergoing cardiac~     surgery.~      Primary objective of the present study is to test the hypothesis, that GDF-15 is superior to~     a standard preoperative risk score, the additive Euroscore for the prediction of 30 day~     mortality and postoperative morbidity in patients scheduled for cardiac surgery.~      Secondary objectives are to test the predictive value of hsTNT, either alone, or in~     combination with GDF-15 and if GDF-15 adds additional information to NTproBNP levels and~     preoperative cerebral oxygen saturation (ScO2) levels.~   "
183239|NCT01166347|"~     The purpose of this study is to determine the safety and effectiveness of the HeartWare~     Ventricular Assist System in patients with chronic Stage D/ New York Heart Association (NYHA)~     Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy,~     and who are ineligible for cardiac transplantation.~   "
183240|NCT01166334|"~     Would you like to quit smoking?~      Seattle's Fred Hutchinson Cancer Research Center is launching a new study that may be able to~     help. Participants who enroll in this study will be randomly assigned by computer (like~     flipping a coin) to one of two online programs. The goal of this study is to learn which of~     these programs is the most effective at helping people stop smoking. Findings from this study~     will be used to help build more effective online smoking cessation programs in the future.~      Participants in both of the smoking cessation programs used in this study will receive:~        -  Interactive tools for dealing more effectively with urges to smoke~        -  Step-by-step guides for quitting smoking~        -  Personalized plans for quitting and remaining smoke-free~        -  Electronic links for reaching one-on-one expert help for quitting~      Participants will be asked to complete online questionnaires, including a brief three-month~     follow-up survey.~      There is no cost for participating in this study.~      To enroll in this study or for more information, please visit www.webquit.com.~      This study is being conducted by Seattle's Fred Hutchinson Cancer Research Center~     (www.fhcrc.org), a world leader in advancing the prevention, diagnosis and treatment of~     cancer. The principal investigator for the WebQuit smoking cessation study is Dr. Jonathan~     Bricker, a faculty member at both the Hutchinson Center and at the University of Washington~     in Seattle.~   "
183241|NCT01166321|"~     Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical~     resection. With this approach, local control ranges between 50 and 70%, depending on~     resection status. A series or smaller studies has shown that postoperative radiotherapy in~     this patient population can increase progression-free survival, which translates into~     increased overall survival. However, meningiomas are known to be radioresistant tumors, and~     radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.~      Carbon ions offer physical and biological characteristics. Due to their inverted dose profile~     and the high local dose deposition within the Bragg peak precise dose application and sparing~     of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an~     increased relative biological effectiveness (RBE), which can be calculated between 2 and 5~     depending on the cell line as well as the endpoint analyzed.~      First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion~     radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results~     are promising.~      Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the~     macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the~     clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection~     or biopsy.~      Primary endpoint is progression-free survival rate, secondary endpoints are overall survival,~     safety and toxicity.~   "
183242|NCT01166308|"~     Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy,~     or radiation therapy. In most cases, a full course of radiotherapy has been applied after~     primary diagnosis, therefore application of re-irradiation has to be applied cautiously. With~     modern precision photon techniques such as fractionated stereotactic radiotherapy (FSRT), a~     second course of radiotherapy is safe and effective and leads to survival times of 22, 16 and~     8 months for recurrent WHO grade II, III and IV tumors.~      Carbon ions offer physical and biological characteristics. Due to their inverted dose profile~     and the high local dose deposition within the Bragg peak precise dose application and sparing~     of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an~     increase relative biological effectiveness (RBE), which can be calculated between 2 and 5~     depending on the Glioblastoma (GBM) cell line as well as the endpoint analyzed. Protons,~     however, offer an RBE which is comparable to photons.~      First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of~     primary high-grade gliomas showed promising results in a small and heterogeneous patient~     collective.~      In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared~     to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in~     patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose~     (RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the~     subsequent randomized Phase II part, the RD will be evaluated in the experimental arm,~     compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy.~      Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II~     is survival after re-irradiation at 12 months, secondary endpoint is progression-free~     survival.~   "
183258|NCT01166100|"~     The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride~     Delayed-Release Capsules, 90 mg and Prozac ® weekly under fasting conditions.~   "
183245|NCT01166269|"~     The purpose of the study is to try a new route for specific immunotherapy (SIT). The current~     treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50~     injections subcutaneously in the upper arm.~      The investigators believe that there is additional effect if the allergen is injected~     directly into the lymph node, since it is here, the allergen presentation is happening. The~     trial has been performed in Switzerland with significant effect of only three injections of~     grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).~      The investigators would like to see what happens if the the dose is doubled, so the patients~     will receive 6 injections all in all, with the same amount of allergen as the earlier study~     (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note~     their symptoms in a diary.~      The patients will be divided into three groups using allocation:~      1 group with 6 injections of allergen~      1 group with 3 injections of allergen and 3 injections of placebo~      1 group with 6 injections of placebo. The trial will be double blinded.~   "
183246|NCT01166256|"~     Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However,~     invasive mechanical ventilation is associated with a variety of complications. Non-invasive~     ventilation has been presented as an alternative treatment but controversy remains. The~     investigators hypothesize that high-flow nasal cannula system is effective enough to prevent~     intubation in acute hypoxemic respiratory failure and not inferior to non-invasive~     ventilation.~   "
183247|NCT01166243|"~     The objective of this study is to evaluate the safety and and hemostatic effectiveness of the~     Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding~     during hepatic surgery.~   "
183248|NCT01166230|"~     The study is intended to investigate whether the improved initial detection and resection of~     bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix~     (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences~     compared to standard white light cystoscopy/TURB.~   "
183249|NCT01166217|"~     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The~     primary purpose of this trial is to evaluate the relative bioavailability of three different~     oral dose formulations of PF-04620110.~   "
183250|NCT01166204|"~     Our group has shown that increasing the radiation dose to pre-specified normal tissue dose~     constraints could lead to increased TCP with the same NTCP in patients with non-concurrent~     and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a~     prospective study in patients with stage I-III NSCLC, who are selected for high-dose~     radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has~     become standard, but the patterns of recurrence and the possibility for dose-escalation in an~     individualised setting have never been investigated properly.~   "
183251|NCT01166191|"~     The investigators' group was the first to perform a phase II trial in patients with limited~     disease (stage I-III) small-cell lung carcinoma (SCLC) in which only the~     fluorodeoxyglucose-positron emission tomography (FDG-PET) positive lymph nodes were~     irradiated. In this trial, only 3% of isolated nodal failures were observed. However, all~     patients in that study were treated with 3D conformal radiotherapy (3DCRT). At present, IMRT~     techniques have become more standard in lung cancer. Because of the lower radiation dose to~     the lymph nodes outside of the planning target volume (PTV) with IMRT, higher incidences of~     isolated nodal failures may occur. In this trial, the investigators will investigate the~     patterns of local relapse after IMRT with concurrent chemotherapy in patients with stage~     I-III SCLC.~   "
183252|NCT01166178|"~     This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg~     intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis~     and to support the optimal use of zoledronic acid for this indication. Primary objective is~     the change of Bone Mineral Density (BMD) at lumbar spine (L1-L4) and total hip region~     assessed by T-Score at month 12 relative to screening as measured by Dual X-ray~     Absorptiometry (DXA). This double-blind period will be followed by a 52-week open-label~     treatment phase to assess long-term efficacy and safety of zoledronic acid in these patients.~   "
183253|NCT01166165|"~     High blood pressure is related to increased risk of cardiovascular disease and death, and~     accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a~     seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is~     more common during months where UVB radiation from the sun is absent, and vitamin D has been~     associated with high blood pressure. This study will evaluate the effect of vitamin D~     replacement during winter months on blood pressure and vasoactive hormones in patients with~     high blood pressure.~   "
183254|NCT01166152|"~     The purpose of this study is to develop a new diagnostic method for developmental disorders~     based on behavior recording during the interview of the subjects by medical staff as well~     anonymous persons. The behavior recording by video camera will be accompanied by non-invasive~     physiological recordings, including electroencephalogram (EEG), electrocardiogram (ECG),~     electromyogram (EMG), and body temperature using infrared (IR) thermograph. Thus, the~     physiologically relevant and the disorder correlated behavior parameters could be extracted~     and used as new diagnostic markers. If necessary, the medical staff may take blood sample~     from the subject before and after the interview. For the longitudinal study, the similar~     interview and the recording of the same subject will be planned to evaluate the effect of the~     medical and educational intervention. The investigators also examine the synergistic effect~     of the intervention and the administration of the supplement (e.g., vitamin D, arachidonic~     acid, coenzyme Q10 (CoQ-10)). The clinician may use Risperidone.~   "
183255|NCT01166139|"~     A phase IIa open-label single center pilot study to assess the safety and efficacy of~     Nilotinib in patients with Scleroderma.~   "
183256|NCT01166126|"~     The purpose of this study is to find out how often two investigational drugs that are given~     together will shrink the patient's tumor and how well they will prolong the time it takes~     their tumor to grow. The investigators also wish to find out how they affect certain~     substances in the patient's tumor and in their blood important for tumor growth. The~     combination of these drugs is experimental, and has not been proven to help treat melanoma~   "
183257|NCT01166113|"~     This study will evaluate if the combination of Pomalidomide, Cyclophosphamide and Prednisone~     is safe and provides benefits in patients with multiple myeloma relapsed and/or refractory to~     lenalidomide.~   "
183261|NCT01166061|"~     Grass pollen allergens are universally recognised as a major cause of allergic diseases in~     humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis.~     Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and~     between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen.~      ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine,~     currently being developed for the treatment of grass allergy.~      The purpose of the present study is to evaluate the safety and tolerability of multiple~     ascending doses of ToleroMune Grass in subjects allergic to grass.~   "
183262|NCT01166048|"~     Objective:~      The objective of this study is to compare the efficacy of duloxetine in the treatment of~     patients with chronic low back pain with a radicular component to placebo.~      Study hypothesis:~      Duloxetine is a new substance now in use for the treatment of neuropathic pain. It has proven~     its efficacy in diabetic peripheral neuropathy and fibromyalgia in several trials. The~     investigators therefore hypothesize that duloxetine will be efficacious in patients with~     chronic low back pain and a radicular component.~      Study Rationale:~      Chronic low back pain is an extremely common diagnosis. However, therapeutic options for the~     condition are limited and therapy remains difficult. Duloxetine has proven its efficacy in~     patients with neuropathic pain and may also be useful in chronic low back pain. If the~     investigators are able to show a benefit for patients in the duloxetine arm, the substance~     may constitute a further treatment alternative in chronic low back pain.~      Study Design:~      Prospective, randomized, double-blind placebo-controlled cross over study. Patients will be~     administered duloxetine for 4 weeks followed by a 2 week wash-out phase after which they will~     be medicated with placebo for 4 weeks. A second group of patients will receive the medication~     in reversed order. The primary study endpoint is constituted the weekly mean of VAS-Score in~     the last week of each treatment period. Secondary endpoints are defined as use of rescue~     medication, Beck Depression Inventory score, Health related Quality of Life SF-36 score and~     side effects/adverse events.~   "
183263|NCT01166035|"~     This is a Phase 1/2, open-label, monocentric, dose-escalation study of lenalidomide in~     combination with cetuximab in subjects with solid tumors. The primary objective is to~     establish the maximum tolerated dose (MTD) of lenalidomide in combination with cetuximab in~     patients with solid tumors including colorectal cancer (CRC), squamous cell carcinoma of the~     head and neck (SCCHN) and non-small cell lung cancer (NSCLC).~   "
183264|NCT01166022|"~     This study is being conducted to test whether exercise can be effectively used as an~     intervention to treat Spinal Muscular Atrophy (SMA). In order to answer this question, the~     investigators will enroll 14 subjects with SMA between ages 8 and 50 and ask them to complete~     an 18 month training schedule. At some points subjects will be asked to closely follow a~     specific training regimen and at other points they may be asked to exercise in the same~     manner they do normally. The exercises they will be asked to perform include biking on a~     stationary cycle and lifting hand weights. Subjects will be asked to come in to the clinic~     seven times over the course of the study to perform tests. These tests include motor function~     measures, a physical exam, questionnaires, a exercise capacity test which involves riding a~     stationary bicycle, and test where the subject is asked to walk as far as they can in six~     minutes. The main goal of the study is to see if the subjects who participate in the exercise~     protocol have larger increases in the distance they can walk in six minutes than those who do~     not.~   "
183265|NCT01166009|"~     The primary purpose of the Research Database is to have a comprehensive source of~     observational data that can be used to study HSC transplantation and cellular therapies.~      A secondary purpose of the Research Database is to have a comprehensive source of data to~     study marrow toxic injuries.~      Objectives:~      To learn more about what makes stem cell transplants and cellular therapies work well such~     as:~        -  Determine how well recipients recover from their transplants or cellular therapy;~        -  Determine how recovery after a transplant or cellular therapy can be improved;~        -  Determine how access to transplant or cellular therapy for different groups of patients~          can be improved;~        -  Determine how well donors recover from the collection procedures.~   "
183266|NCT01165996|"~     RATIONALE: Decitabine may help myelodysplastic cells become more like normal stem cells.~     PURPOSE: This clinical trial studies differentiation therapy with decitabine in treating~     patients with myelodysplastic syndrome.~   "
183267|NCT01165983|"~     The purpose of this research is to study and determine the effects of Aliskiren on blood~     vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial~     function by 30% or more in comparison to the placebo group.~   "
183268|NCT01165970|"~     Symptomatic hyposalivation is associated not only with Sjögren`s syndrome or salivary gland~     hypofunction in elderly patients, but also with medications containing antimuscarinic drugs,~     chemo radiotherapy for head and neck carcinomas, and psychiatric disorders (Atkinson & Ava,~     1994, Kielbassa et al., 2006).~      Human saliva possesses important physiological functions in protecting and moistening the~     oral hard and soft tissues (Piotrowski et al., 1992, ). Consequently, decreasing salivation~     causes oral dysfunction and promotes severe oral side effects (reduced antibacterial~     function, lack of remineralisation, reduced buffer capacity) (Tschoppe et al., 2010a). These~     have been identified as being responsible for the rapid destruction of the dentition (Willich~     et al., 1988). Saliva substitutes are frequently applied for relieving the symptoms in~     patients suffering from hyposalivation (Hahnel et al., 2009, Nieuw Amerongen & Veerman, 2003,~     Vissink et al., 2004). Besides the moistening and lubrication of the oral mucosa, these~     products should also protect dental hard tissues. However, in vitro studies revealed that~     some marketed products have only a neutral or even a demineralising potential on enamel as~     well as on dentin (Kielbassa et al., 2001, Meyer-Lueckel et al., 2002, Smith et al., 2001,~     Tschoppe et al., 2009). Inorganic ions such as calcium, phosphates, and fluorides have been~     added to saliva substitutes in order to enhance their remineralising property or minimize~     their demineralising potential (Tschoppe et al., 2009). Furthermore, as most patients~     suffering from hyposalivation are elderly people, recessions and subsequently exposed dentin~     surfaces are very common. Since dentin is not as acid resistant as enamel, an earlier and~     more severe demineralisation can be expected (Saunders & Meyerowitz, 2005).~      Therefore, the current in situ study was performed to assess the effects of a demineralising~     and a remineralising saliva substitutes on the mineralisation of dental hard tissues. It was~     hypothesized that storage in Glandosane(cell pharm, Hannover, Germany) would not result in~     pronounced mineral loss of dentin specimens, and that storage in Saliva natura would not~     result in enhanced remineralisation when combined with a remineralising artificial saliva~     (Saliva natura supersaturated with respect to relevant calcium phosphates; medac, Hamburg,~     Germany) (H0). These null hypotheses were tested against the alternative hypothesis of a~     difference.~   "
183332|NCT01165138|"~     The purpose of the study is to compare the efficacy and safety of fluticasone~     furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder~     both administered once daily in adolescent and adult subjects 12 years of age and older with~     persistent bronchial asthma over a 12 week treatment period.~   "
183269|NCT01165957|"~     The purpose of this study is to determine the amount of polyethylene wear associated with~     knee replacement designs that incorporate either a fixed or mobile bearing. Tibial~     polyethylene inserts retrieved from modular total knee replacements during revision~     operations will be analyzed by obtaining micro-CT images of the retrieved inserts. The~     components of total volumetric polyethylene loss, including wear associated with the medial~     articular, lateral articular and backside regions of the insert be quantified by comparing~     the worn insert with an unworn control. The investigators hypothesize that the fixed bearing~     inserts where the polyethylene is locked to the metal baseplate will demonstrate more~     volumetric wear than the mobile bearing inserts that are designed to slide or rotate on the~     metal baseplate.~   "
183270|NCT01165944|"~     Post-transplant diabetes mellitus (PTDM) develops in up to 30% of patients undergoing solid~     organ transplantation. This disease is difficult to treat as the levels of glycemia fluctuate~     in response to variations in doses of steroid and other immunosuppressive agents. At the same~     time, poorly controlled hyperglycemia affects negatively graft function and survival as well~     as on the ability of the immunocompromised host to fight infections. The investigators~     hypothesize that the addition of Pramlintide (Symlin) to the management of patients with PTDM~     would help patients with post-transplant diabetes attain better control at the critical time~     of titration of immunosuppressive regimens. The primary objective of this proposal is to~     improve glycemic control of diabetes with Pramlintide in patients with post-transplant~     diabetes at 3 and 6 months of therapy.~   "
183271|NCT01165931|"~     The aim of the study is to assess the effects of intracoronary Riociguat on coronary blood~     flow in subjects with coronary artery disease and to compare this effect with the~     intracoronary nitroglycerin, a coronary vasodilator widly used to treat patients with~     coronary artery disease.~   "
183272|NCT01165918|"~     The purpose of this study is~        1. To generate human embryonic stem cells lines (hESC) lines~        2. Study of the factors that contribute to differentiation towards germ cell.~   "
183273|NCT01165905|"~     Treatment of cancer is often more effective when two or more drugs are used together. For~     example, when gemcitabine, an approved drug, and ON 01910.Na, a new investigational~     anti-cancer drug, are used together to treat cancer cells in laboratory animals, there is~     more inhibition of the growth of the cancer cells compared to either drug used by itself.~     These results offer promise that gemcitabine and ON 01910.Na could be used to treat cancer in~     patients. However, before studies that seek to find out if gemcitabine and ON 01910.Na is an~     effective combination in patients can be done, doctors must first know what is largest, safe~     dose of ON 01910.Na that can be used in combination with gemcitabine and what is the best~     regimen to use. This study is designed to answer that question.~   "
183274|NCT01165892|"~     The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in~     magnetic resonance imaging (MRI).~   "
183275|NCT01165879|"~     The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures~     uterine contractions based on the electrical activity of the uterine muscle.The study will~     compare the EUM100pro measurements to the already existing uterine contractions monitors~     (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of~     uterine contractions.~   "
183276|NCT01165866|"~     Is intravenous metoclopramid as effective as intravenous ondansetron in the treatment of~     persistent vomiting in patients with acute gastroenteritis.~   "
183277|NCT01165853|"~     The purpose of this study is compare the effects of consuming glucose- and fructose-sweetened~     beverages on appetite, body weight, body fat, and the amount of energy the body burns as well~     as effects on blood pressure, hormones, blood triglycerides and cholesterol, and the body's~     sensitivity to the insulin.~   "
183278|NCT01165840|"~     This study will find how weight affects the dosing of a drug called dapsone. Currently, the~     amount of dapsone a patient receives is the same regardless of the patient's weight.~   "
183279|NCT01165827|"~     1. Research aims~           The increasing prevalence of severe aortic valve defects is a corollary to increases in~          life expectancy. For many years, surgical valve replacement with extracorporeal~          circulation has been the gold standard in the treatment of severe aortic valve diseases.~          Every year, about 12,000 patients in Germany receive isolated aortic valve surgery.~          Several alternatives to established procedures have recently emerged:~             -  V-TAVI, vascular transcatheter aortic valve implantation and~             -  A-TAVI, apical transcatheter aortic valve implantation. For some time, percutaneous~               balloon valvuloplasty has been used as a palliative measure for specific patients.~           New developments have triggered assumptions that there will over the coming years be a~          certain reorientation to the treatment of patients with aortic valve defects. In a~          positioning paper published jointly by the German Cardiac Society (DGK) and the German~          Society for Thoracic and Cardiovascular Surgery (DGTHG), there is a consensus that these~          new techniques can be used on patients who have either contraindications against~          conventional surgery or who are at high risk of preoperative mortality, e.g. due to~          severe comorbidities.~           As there is as yet only limited experience in this field and neither randomised trials~          nor long-term-results are available, the use of new implantation techniques is therefore~          not recommended for younger patients or patients without comorbidities. There is~          accordingly an urgent need for any introduction of this innovative medical procedure to~          be stringently monitored according to scientific principles. The goal of the planned~          Germany Aortic Valve Register is to evaluate the new treatments from the point of view~          of benefits und risks with respect to the gold standard of conventional surgery, with a~          view to compiling evidence-based indication criteria. The register will furthermore~          allow for the first time a comparison of various operative procedures, such as Ross~          procedure, David procedure and various mechanical or biological aortic valve implants.~        2. Rationale of the study design Randomised trials in controlled environments are~          considered best scientific practice for verifying the efficacy of a new method. The~          disadvantage is that only a small part of potential patients can be included in the~          trial, and results therefore reflect only a small section of the real world.~          Furthermore, a randomised study design is for ethical reasons not an acceptable approach~          to all questions, especially when contraindications exist for a certain branch of~          treatments and the spectrum of treatments is to be expanded. Nevertheless, new~          procedures have to be critically and scientifically analysed if the risk-benefit ratio~          is to be accurately determined. National heath authorities therefore request register~          data in addition to controlled trials in order to verify the safety and efficacy of new~          procedures across larger patient populations.~        3. Objectives~             1. Description of structure, process and outcome quality for the various techniques of~               aortic valve therapies~             2. Definition of indication criteria (e.g. through scoring systems)~             3. Collection of information on quality and safety for special medical devices~             4. Evaluation of quality of care on the level of participating centres with a view to~               increasing quality~             5. Health economic evaluation of the applied treatments~        4. Study design Prospective, controlled, multicenter register study~   "
183280|NCT01165814|"~     Oral naproxen might be more efficacious for post-cesarean pain-control and have better~     side-effects profile than oral tramadol.~   "
183281|NCT01165801|"~     The purpose of this study was to find out if in patients with non-exudative age-related~     macular degeneration (AMD), randomly assigned to cataract surgery, any AMD size progression~     or progression to exudative AMD could be detected 6 months after surgery.~   "
183282|NCT01165788|"~     1. To explore specific aspects of social adaptation such as social connectedness,~          occupational outcomes and family relationships in lymphoma patients after autologous~          blood or marrow transplantation (BMT).~        2. To investigate how social adaptation varies with time lapsed since BMT and with the life~          stage as determined by patient?s age. Understanding both the positive and negative~          aspects of cancer and cancer therapy leads to opportunities to promote adaptive~          strategies.~   "
183283|NCT01165775|"~     We hope to clarify how betamethasone affects glucose levels in the mother in the days after~     receiving the drug. This understanding will hopefully allow us to better anticipate the risk~     of maternal hyperglycemia and therefore establish more appropriate monitoring of maternal~     glucose to prevent maternal and neonatal complications of hyperglycemia.~   "
183284|NCT01165762|"~     The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone~     marrow Transplantation are enrolling patients into a research study to determine if donor~     stem cells given after a living related one Haplotype match kidney transplantation will~     change the immune system such that immunosuppressive drugs can be completely withdrawn.~   "
183285|NCT01165749|"~     The long term health and cardiovascular benefits of a regular exercise program have been~     well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e.~     walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy~     (HCM). However, data on potential benefits of recreational exercise, useful parameters for~     risk stratification, and methods of devising individual exercise prescriptions are completely~     lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise~     training program in patients with HCM, and 2) to determine whether exercise training improves~     ability to perform activities and tasks, heart size and function, and quality of life in~     patients with HCM.~   "
190871|NCT01066026|"~     The purpose of this study was to assess the safety and efficacy of a new metallic cannula to~     inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard~     needle.~   "
183288|NCT01165710|"~     The ORBIT-AF registry will be a multicenter, prospective outpatient disease registry to~     identify real world treatment patterns of atrial fibrillation. The registry will describe~     this patient population with regards to demographics, clinical factors, risk stratification,~     and geographic regions. In particular, attention will be focused on the utilization,~     effectiveness, and safety of antithrombotic therapies in the prevention of stroke. The~     registry is designed to identify reasons and risk factors for non-receipt of anticoagulation~     (AC) therapy, as well as reasons why AF patients who are prescribed AC therapy do not take~     them.~   "
183289|NCT01165697|"~     Fabry disease, an x-linked recessive lysosomal storage disease (LSD) is commonly recognized~     as a cause of renal failure in involved men and more recently recognized in women too. Women~     are involved in significant numbers and with complications, as are men, of vascular disease.~     This manifests as unexpected strokes in young adults. We have morphologic evidence that~     storage-endotheliopathy induced microvascular disease is the cause of cardiopathy and of~     cryptogenic strokes, and that storage endotheliopathy starts in early life, probably before~     birth. Based on our earlier work with other endotheliopathies such as diabetes mellitus,~     Susac syndrome, and hypertension, we will find and study patients using unique methods,~     neuro-retinal fluorescein angiography (NRFA), that we have developed for this purpose. These~     methods include NRFA to demonstrate capillary perfusion in the optic nerve head and retinal~     quadrants. We anticipate, based on our earlier experience with other endotheliopathies, that~     we will show more vascular pathology earlier than previously reported. Using epidemiologic~     and genetic tools we will find more patients than previously known or expected. It will offer~     opportunity for earlier diagnosis, prognosis, and response to enzyme replacement therapy.~      We hypothesize that Fabry disease is a poorly recognized and poorly characterized cause of~     microvascular disease and cryptogenic strokes in young women and men. Neuroretinal capillary~     perfusion abnormalities in Fabry disease will be predictive of equivalent vascular disease in~     kidney, heart, brain and other organs, and further that it will be responsive to change~     induced by enzyme replacement therapy treatment.~   "
183290|NCT01165684|"~     This trial is conducted in Europe, and North and South America. The aim of this clinical~     trial is to investigate if the two treatments are equally effective.~   "
183291|NCT01165671|"~     Treatment standard for patients with primary glioblastoma (GBM) is combined radiochemotherapy~     with temozolomide (TMZ). Radiation is delivered up to a total dose of 60 Gy using photons.~     Using this treatment regimen, overall survival could be extended significantly however,~     median overall survival is still only about 15 months.~      Carbon ions offer physical and biological advantages. Due to their inverted dose profile and~     the high local dose deposition within the Bragg peak precise dose application and sparing of~     normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase~     relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on~     the GBM cell line as well as the endpoint analyzed. Protons, however, offer an RBE which is~     comparable to photons.~      First Japanese Data on the evaluation of carbon ion radiation therapy showed promising~     results in a small and heterogeneous patient collective.~      In the current Phase II-CLEOPATRA-Study a carbon ion boost will be compared to a proton boost~     applied to the macroscopic tumor after surgery at primary diagnosis in patients with GBM~     applied after standard radiochemotherapy with TMZ up to 50 Gy. In the experimental arm, a~     carbon ion boost will be applied to the macroscopic tumor up to a total dose of 18 Gy E in 6~     fractions at a single dose of 3 Gy E. In the standard arm, a proton boost will be applied up~     to a total dose 10 Gy E in 5 single fractions of 2 Gy E.~      Primary endpoint is overall survival, secondary objectives are progression-free survival,~     toxicity and safety.~   "
183292|NCT01165658|"~     The goal of this clinical research study is to study the safety of giving larger daily doses~     of proton radiation therapy than the standard dose levels given to treat lung cancer.~     Researchers want to find the highest daily dose of proton radiation that can be given without~     having to stop therapy due to side effects.~   "
183293|NCT01165645|"~     RATIONALE: HIV protease inhibitors, including Lopinavir/Ritonavir have intrinsic~     anti-apoptotic properties in addition to their anti-viral effect on HIV. This anti-apoptotic~     effect may boost the immune system to help the body create a better immune response to~     vaccines. PURPOSE: This randomized clinical trial studies giving lopinavir and ritonavir~     together in improving immune response to vaccines in patients with complete remission~     following a bone marrow transplant for Hodgkin lymphoma.~   "
183294|NCT01165632|"~     RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may~     help in guiding surgery and radiation therapy and allow doctors to plan better treatment.~      PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning~     surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade~     malignant glioma~   "
183295|NCT01165619|"~     In this study, we will measure levels of reproductive hormones and metabolic markers in~     subjects with isolated GnRH deficiency disorders and compare them to healthy control~     populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in~     healthy subjects and those with reproductive disorders and (2) to correlate reproductive and~     metabolic phenotypes with genetic changes within patients with reproductive disorders and~     healthy controls.~   "
183296|NCT01165606|"~     This study aimed to determine the impact of providing chest physiotherapy on the duration of~     mechanical ventilation, intensive care length of stay, intensive care and hospital mortality~     in mechanically ventilated patients.~   "
183297|NCT01165593|"~     The purpose of this study is to gather information about the size and shape of patients'~     hearts in order to design a device.~   "
183298|NCT01165580|"~     This open label study will assess the pharmacokinetics and the safety and tolerability of~     Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant~     patients < 4 months of age.~   "
183333|NCT01165125|"~     A randomized two-way crossover study to determine whether concomitant administration of CYP~     P450 3A4 inhibitor ketoconazole and fluticasone furoate/GW642444M combination significantly~     increases the systemic effects and exposure to repeat dose fluticasone furoate and/or~     GW642444 in healthy subjects. Key assessments will include blood potassium, heart rate, blood~     pressure, QTc, serum cortisol and pharmacokinetic parameters, and safety including vital~     signs, ECGs, adverse event monitoring and laboratory safety tests, including blood glucose.~   "
183299|NCT01165567|"~     Background:~      Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased~     morbidity and mortality, particularly in patients with chronic renal insufficiency. Although~     some agents including hydration with saline are being prescribed to prevent renal~     deterioration in these high risk patients, their efficacy is not clear defined and debatable.~     Therefore additional prophylactic pretreatments are needed.~      Methods/Design:~      Present study aims to investigate differences in occurrence of CIN after sarpogrelate~     premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85~     years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to~     one of two conditions: (i) a routine treatment without sarpogrelate group (ii) routine~     treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the~     occurrence of CIN during 4 weeks after receiving contrast agent.~      Discussion:~      As of May 2010, there were no registered trials evaluating the therapeutic potentials of~     sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function~     and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.~   "
183300|NCT01165554|"~     To determine the level of association between quantitative regional estimates of brain uptake~     of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels~     of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.~   "
183301|NCT01165541|"~     The purpose of the study is to test whether taking two medicines (quetiapine and mirtazapine)~     is better for helping people to decrease drinking than taking one medicine alone~     (quetiapine).~   "
183302|NCT01165528|"~     Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care~     Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh.~     The study is approved by the Institute Ethics committee. In view of lack of previous outcome~     data in such patients, all patients requiring RICU admission for acute respiratory distress~     syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study.~      The patients meeting the aforementioned criteria will randomly assigned to ventilation with~     assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support~     ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized~     on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence~     will be computer generated. The assignments will placed in sealed opaque envelopes and each~     patient's assignment was made on admission to the RICU by the attending physician. Blinding~     of treatment is not possible.~      All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems,~     Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to~     low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a~     saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30~     cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory~     rate to 35/ min to achieve the above said goals11.These patients will be weaned as per~     standard protocol of spontaneous breathing trial of 30 minutes once they are recognized~     eligible as per statement of the sixth International consensus conference on weaning.~   "
183303|NCT01165515|"~     Endostatin, a 20-kDa cleavage product of collagen XVIII, is a component of the extracellular~     matrix expressed in the basement membrane. As a potent inhibitor of angiogenesis, endostatin~     induces endothelial cell apoptosis and diminishes cell migration, adhesion and proliferation.~      Endostatin may stop the progression of atherosclerosis. Atherosclerotic heart disease~     involves unwanted tissue growth. By cutting off the blood supply from a plaque the likelihood~     of plaque rupture may eventually be reduced. Recent data indicates that the loss of collagen~     XVIII/endostatin is related to the enhancement of neo-vascularization and vascular~     permeability in atherosclerosis. Plaque neo-vascularization strongly correlates with the~     regional content of inflammatory cells. Furthermore, increased vascular permeability enhances~     lipid accumulation in the vessel walls, hence increasing foam cells.~      Therapeutic angiogenesis is a most promising strategy for the treatment of myocardial~     infarction. However, it remains unknown if and how endogenous angiogenesis inhibitors, such~     as endostatin, regulate angiogenesis in myocardial infarction. Rat models showed that after~     myocardial infarction endostatin neutralization displayed adverse left ventricular remodeling~     and severe heart failure compared with controls. Although angiogenesis was increased, tissue~     remodeling and interstitial fibrosis were further exaggerated in post-myocardial infarction~     hearts by endostatin neutralization.~      However, several studies suggest that endostatin may locally modulate coronary collateral~     formation by inhibiting collateral vessel formation in patients with ischemic heart disease.~      During treadmill exercise tests in healthy volunteers a significant increase in circulating~     endostatin levels can be observed. Exercise induces angiogenesis in cardiac and skeletal~     muscles by decreasing endostatin in the muscle tissues to increase blood flow to these~     metabolically active tissues. Thereby endostatin is released into the general circulation.~      In summary, endostatin might be a new weapon to fight against atherosclerotic progression by~     inhibiting neo-vascularization of atherosclerotic plaques.~   "
183304|NCT01165502|"~     The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue~     CM3.1-AC100 after repeated subcutaneous (sc) doses.~   "
183305|NCT01165489|"~     Laryngomalacia is the most common congenital malformation of the larynx. It results from~     abnormal prolapse of supraglottic structures during inspiration. Symptoms usually appear~     within the first 2 weeks of life. Its severity increases in up to 6 months. 15-60% of infants~     with laryngeomalacia have synchronous airway anomalies.~   "
183306|NCT01165476|"~     The purpose of this study is to compare the bioavailability of a single 1mg dose of~     treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent~     facilities.~   "
183307|NCT01165463|"~     This is second-generation study based on results from ACTIVE (Advanced Cognitive Training for~     Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy and~     Active Minds Study). The investigators will formally test from an intent-to-treat perspective~     for differences on the primary and secondary outcomes based on whether participants were~     randomized to the basic on-site speed of processing training (SOPT) group (G1), to the~     on-site basic SOPT plus subsequent booster-training group (G2), to the basic at-home SOPT~     group (G3), or to the basic attention-control group (G4). Basic training involves 10 hours of~     either the SOPT or attention-control training during the first 6 weeks of participation.~     Booster-training involves 4 additional hours of SOPT training at 11 months of participation.~   "
183308|NCT01165450|"~     The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with~     persistent corneal epithelial defects (PED) resulting from corneal epithelial debridement~     during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns, post-PRK, or~     post-corneal transplant surgery.~   "
183344|NCT01164982|"~     The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds~     in home care.~      Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at~     removal, transparency of dressing and adverse events.~   "
183309|NCT01165437|"~     Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD~     are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is~     the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms~     and legs using a Doppler device. The need for dedicated equipment and trained personnel,~     along with the time required to perform the test, have been identified as barriers to~     widespread implementation of ankle-brachial index screening. The use of automated~     oscillometric devices for blood pressure measurement has been applied to leg pressure~     measurement and determination of the ankle-brachial index with variable success. It will be~     beneficial to investigate a reliable oscillometric-based procedure that can accurately~     measure leg pressures for the ankle-brachial index across the entire spectrum of PAD~     severity.~      In a previous pilot study completed in 2009 (IRB 08-823), the investigators gathered data~     from N=60 subjects which allowed for mathematical analysis of oscillometric waveforms derived~     from the lower extremities as compared to Doppler-based measurements of blood pressure. We~     used signal processing analysis and regression techniques to develop a two-step algorithm~     which will allow for accurate interpretation of oscillometric waveforms in normal/mild vs.~     moderate/severely diseased limb and accurate calculation of ankle pressure across the~     spectrum of peripheral artery disease severity.~      This proposed project will validate this novel oscillometric ABI algorithm in a population of~     patients who have been identified as at risk for PAD and for whom screening ABI has been~     recommended by multiple professional organizations (AHA/ACC and American Diabetes~     Association). Arm, ankle, and toe pressure measurements will be made in the supine position~     using Doppler, oscillometric methods, and a photoplethysmographic sensor. The ankle-brachial~     index and toe-brachial index will be calculated.~   "
183310|NCT01165424|"~     Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center,~     open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be~     administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a~     dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal~     representatives) provided consent to continue treatment beyond 12 weeks will receive~     treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal~     symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse~     events and trial procedure-related AEs will be reviewed 30 days after the end of the~     follow-up.~   "
183311|NCT01165411|"~     It has been estimated that 90% of bloodstream infections associated with catheters, are due~     to CVCs, and that 500 to 4,000 patients in the United States die annually due to these~     bloodstream infections. The risk of central line associated bloodstream infections is~     typically expressed as the number of line infections per 1000 catheter days. This study's~     goal is to develop a uniform CL protocol, updated practice guidelines based on current~     evidence, and a standard procedural checklist based on CL care bundles recommended by the~     Institute for Healthcare Improvement. A secondary goal is to create a CL registry to capture~     and store data relevant to each CL placed throughout the institution. This registry will~     provide a wealth of data on CL insertions and complications that may be used as a valuable~     source of information for quality assurance, performance improvement, and research. With the~     knowledge and information obtained through this registry, educational offerings can be~     created, and a standardized institutional process for CL insertion can be developed.~   "
183312|NCT01165398|"~     An estimated 250,000 cases of central line-associated bloodstream infections occur in US~     hospitals annually, and an estimated 30,000 to 62,000 patients die as a result, the marginal~     cost of which to the health-care system is approximately $25,000 per episode. Inconsistent~     and outdated clinical practices have been identified as key causative factors. In order to~     improve overall healthcare delivery and outcomes, current and future healthcare professionals~     need to complement their clinical skills with systems-based skills. Specific to the problems~     of central lines, during a 2005 chart review of institutional patient safety issues, a LVHN~     internal quality committee found multiple cases involving the insertion of central lines,~     including cases involving arterial placement and malposition. The internal quality committee~     review revealed that newer residents were primarily involved in these cases. As a result of~     the committee's findings and review of the literature, a standardized Central Line Access and~     Placement course was designed as part of the incoming residents'orientation process. This~     study's goal was to contribute to the knowledge-base of health professional education and to~     build a sustainable model for one set of learning and development interventions, with the~     expectation that findings will have broad relevance for patient safety initiatives, health~     professional training and development programs, and healthcare delivery improvement.~   "
183313|NCT01165385|"~     The aim of this research is to evaluate the potential interest of an association of~     Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin.~      As cisplatin has marketing approval for several cancers (ovarian, testicle, bladder,~     esophagus, endometrium, lung, stomach, head and neck cancer (HNC)), and in order to have a~     rapid evaluation of this combination, we will evaluate the combination in any patient whose~     tumors is known to be sensible to cisplatin (except tumors at risk of bleeding).~      This study is a classical phase 1 trial of pazopanib and 3-weekly cisplatin association. It~     will allow for optimal dose selection and pharmacokinetic analysis. It is planed to include~     around 38 patients, enriching the optimal tolerated regimen (OTR) level only with a cohort of~     triple negative breast cancer patients. If the association is proven to be feasible, we will~     then move to a specific phase II study in triple negative breast cancer patients.~   "
183314|NCT01165372|"~     Background: There are worrying signs from Western Cambodia that parasitological responses to~     artesunate containing treatment regimens for uncomplicated falciparum malaria are slower than~     elsewhere in the world. Delayed parasite clearance and unusually high failure rates with~     artesunate-mefloquine have been reported. These antimalarials are central to current~     treatment strategies and spread of significant resistance outside this area would be a global~     disaster. Radical containment measures are needed. In this context there is an urgent need to~     proceed quickly to investigate whether there is any evidence of resistance to artemisinin~     derivatives in Vietnam.~      Objective: The primary objective is to assess the slope of the decline in the log~     parasitemia-time curve in patients treated with artesunate 2mg/kg/day, artesunate 4mg/kg/day~     or dihydroartemisinin-piperaquine once daily, and to compare the results of this study to the~     pharmacokinetic results and to the recent data from patients in Cambodia and Thailand treated~     with equivalent therapies.~      Methods: The trial will be conducted in Phuoc Long Hospital, Binh Phuoc Province, Vietnam.~     The participants will be febrile patients (aged > 10 years) with slide confirmed~     uncomplicated P. falciparum infection. Patients will be treated with either artesunate~     2mg/kg/day, artesunate 4mg/kg/day or dihydroartemisinin-piperaquine once daily for 3 days.~     Patients on artesunate therapy arms will then receive 3 days of treatment with~     dihydroartemisinin-piperaquine with dosages according to the national guidelines. Clinical~     and parasitological parameters will be monitored over a 42-day follow-up period. The~     pharmacokinetic characteristics of artesunate and dihydroartemisinin will be assessed by~     using a population pharmacokinetic modeling.~   "
183319|NCT01165307|"~     Excessive menstrual loss (menorrhagia) is a common condition that affects women of~     reproductive age, and can result in anemia, chronic fatigue and lost wages from work. The~     traditional first line management involves treatment with oral contraceptives or~     non-steroidal anti-inflammatory agents. Many women ultimately undergo hysterectomy, a major~     operative procedure associated with increased costs, loss of feeling of womanhood,~     debilitating complications and on rare occasions, death.~      The newer global endometrial ablation (GEA) devices allow the destruction of the endometrial~     lining, without the removal of the uterus, in an ambulatory surgery setting. GEA offers a~     safe and effective alternative to hysterectomy with minimal risks and without unpleasant~     side-effects.~      Presently, global endometrial ablation is offered as an alternative to hysterectomy, after~     medical intervention has failed. This study will determine the role of global endometrial~     ablation in the initial management of menorrhagia. Women seeking treatment for menorrhagia~     will be randomized to either the medical treatment arm or the global endometrial ablation~     arm.~      This study will be the first to compare clinical efficacy and costs between oral~     contraceptive pills and global endometrial ablation in the initial management of menorrhagia~     and could potentially change the management of menorrhagia and impact millions of women who~     suffer from this condition.~   "
183320|NCT01165294|"~     The objective of this study is to develop an exploratory design for future Proof-of-Concept~     trials which reliably and accurately measure the central nervous system (CNS) effects of~     potentially new drugs that oppose the effects of ketamine at a subanesthetic dose level given~     to healthy volunteers. A functional magnetic resonance imaging (fMRI) and~     electroencephalogram (EEG) performed simultaneously during a ketamine challenge will register~     the effects triggered by Ketamine.~   "
183321|NCT01165281|"~     The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as~     JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone~     Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant,~     tumor-related cancer pain.~   "
183322|NCT01165268|"~     It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the~     renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.~   "
183323|NCT01165255|"~     The study is an extension of earlier work based on a retrospective epidemiologic study of~     infants born to women who were exposed to bupropion in their estimated first trimester of~     pregnancy using data from a large US health plan affiliated with i3 Drug Safety (Clinical~     study ID WWE113694) (Cole JA, Oh KS, Chiang CC, Walker AM, Haight BR, Modell JG. Bupropion in~     pregnancy and the prevalence of congenital malformations Pharmacoepidemiology and Drug~     Safety, 2007; 16: 474-484). The cohorts developed for the earlier work consisted of all~     infants born to women exposed to bupropion during the estimated first trimester and outside~     the first trimester, and a random sample of infants born to women exposed to other~     antidepressants during the first trimester between 01 January 1995 and 30 September 2004. The~     objectives for this study include refining of both the original first trimester bupropion~     cohort and the original bupropion outside the first trimester cohort into mono-therapy and~     mono- or poly-therapy. Exposure to other antidepressants during the first trimester will also~     be refined into mono-therapy and mono- or poly-therapy. With input from pediatric cardiology~     expert, lists of specific cardiovascular malformations and malformation groupings will be~     created. The groupings will be created among the refined first trimester bupropion cohort as~     well as in two comparison cohorts of bupropion outside the first trimester and first~     trimester antidepressant use (mono-therapy and mono-or poly-therapy). The prevalence in each~     cohort will be calculated as the number of infants with a specific cardiovascular~     malformation divided by the number of live born infants. Prevalence will be reported per~     1,000 infants. Confidence intervals will be calculated using Wilson's approximation to exact~     binomial intervals when the number of cases is five or greater and exact binomial intervals~     when the number of cases is fewer than five. The appropriateness of further calculations will~     be evaluated. Where numbers permit, adjusted odds ratios for specific cardiovascular~     groups/malformations will be calculated and if appropriate, stratified according to maternal~     dispensing of medications suspected to be teratogenic. The following comparisons, if numbers~     permit, will be performed: 1) bupropion first trimester mono-therapy cohort versus other~     antidepressant first trimester mono-therapy cohort; 2) bupropion first trimester mono- or~     poly-therapy cohort versus other antidepressant first trimester mono- or poly-therapy cohort;~     3) bupropion first trimester mono-therapy cohort versus bupropion outside of first trimester~     mono-therapy cohort, and 4) bupropion first trimester mono- or poly-therapy cohort versus~     bupropion outside of first trimester mono- or poly-therapy cohort. Adjusted odds ratios will~     be calculated through a generalized estimated equations form of multivariate logistic~     regression to account for births associated with multiple infants. The same covariates~     identified in the original study will be included in this re-analysis. Covariates included:~     diagnoses of bipolar disorder and eclampsia within one year before delivery; dispensings of~     lithium, phenytoin, and fluconazole within one year before delivery through the end of the~     first trimester; and the number of physician visits within 10 to 12 months before delivery,~     maternal age, geographic region of the health plan, and infant gender. If generalized~     estimating equation form of the logistic regression model does not converge, adjusted odds~     ratios will be presented from a conventional multivariate logistic model. If the conventional~     multivariate logistic model does not converge, only the crude odds ratio will be presented.~   "
183324|NCT01165242|"~     The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK~     Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through~     25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK~     134612 vaccine.~   "
183325|NCT01165229|"~     The purpose of this observer-blind study is to evaluate the efficacy, safety and~     immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70~     years.~      Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be conducted~     concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both~     studies combined will be conducted contingent on each study achieving its objectives. This~     protocol posting also deals with the outcome measures related to the pooled analysis.~   "
183326|NCT01165216|"~     The primary purpose of this study was to establish the recommended dose of ipilimumab~     administered in combination with paclitaxel and carboplatin in Japanese patients with~     nonsmall-cell lung cancer.~   "
183327|NCT01165203|"~     This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline~     (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human~     Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with~     antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated~     subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts.~      This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010.~     The impacted sections is exclusion criteria.~   "
183328|NCT01165190|"~     Mitochondrial dysfunction in skeletal muscle results in decreased muscle fatty acid~     oxidation, leading to conversion of fatty acids into triglycerides and its accumulation~     inside the muscle tissue. Moreover, in adipose tissue mitochondrial dysfunction results in~     decreased fatty acid oxidation and triglyceride synthesis, leading to increased circulating~     fatty acid concentrations, which in turn also leads to lipid accumulation inside muscle~     tissue. Lipid accumulation inside muscle tissue interferes with the insulin signaling pathway~     and causes insulin resistance. Mitochondrial dysfunction in both tissues has therefore been~     proposed to play an important role in insulin resistance in humans.~      Pioglitazone, a thiazolidinedione, is an FDA approved medication for the treatment of type 2~     diabetes. It improves muscle insulin sensitivity at least in part by lowering intramuscular~     lipid concentrations but the mechanism by which this occurs is unclear. In the present study,~     we shall therefore test the hypothesis that pioglitazone improves mitochondrial function in~     muscle and adipose tissue in humans who are insulin resistant.~   "
183334|NCT01165112|"~     This phase I/II trial is studying the side effects and best dose of bendamustine~     hydrochloride when given together with carboplatin, etoposide, and rituximab in treating~     patients with diffuse large B cell lymphoma or Hodgkin lymphoma that has come back after a~     period of improvement or has not responded to previous treatment. Drugs used in chemotherapy,~     such as bendamustine hydrochloride, etoposide, and carboplatin, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting~     certain cells. Giving bendamustine hydrochloride together with carboplatin, etoposide, and~     rituximab may kill more cancer cells.~   "
183335|NCT01165099|"~     The study was primarily designed to assess the role of acupuncture in reducing the need for~     epidural analgesia for pain relief during induced labour. The other outcomes of labour were~     to be observed in addition.~   "
183336|NCT01165086|"~     This study will test the hypothesis that incorporating vegetables into meals as a method of~     reducing the energy density will result in increased vegetable intake and decreased energy~     intake.~   "
183337|NCT01165073|"~     The benefits of short-term naso-gastric feeding in patients with advanced cirrhosis remain~     uncertain. This was a randomised study comparing naso-gastric feeding and oral feeding in~     Asian patients with cirrhosis who were admitted to hospital for decompensation.~   "
183338|NCT01165060|"~     X-linked adrenoleukodystrophy (X-ALD) is an inherited metabolic disorder characterised by~     accumulation of very long chain fatty acids (VLCFA) in plasma and tissue. Presumably this~     accumulation is responsible for tissue damage. The disease can cause severe demyelinisation~     of the central nervous system usually causing death in childhood or progressive ambulatory~     problems in adults caused by a progressive myelopathy. For the latter category of patients no~     curative treatment is currently available. Recent investigations in human fibroblasts and~     mice identified bezafibrate as an agent that might reduce VLCFA in patients with X-ALD.~      Objective of the study:~      The trial is designed as an open-label pilot study. The main goal is to investigate if~     bezafibrate can reduce VLCFA in vivo in patient with X-ALD. If there is indeed a biochemical~     effect, a large follow-up study will be initiated with clinical outcome parameters.~      Study design:~      10 men with X-ALD will use bezafibrate during a period of 6 months (in combination with a low~     fat diet). On 6 different time points the participants will undergo a venipuncture for~     detecting possible side effects and to determine the biochemical outcome parameters.~      Study population:~      Adult men with X-linked adrenoleukodystrophy.~      Intervention (if applicable):~      Bezafibrate.~      Primary study parameters/outcome of the study:~      The primary outcome parameters are cholesterol levels (total-, LDL, and HDL) and levels of~     triglycerides in plasma, VLCFA levels in plasma, leukocytes and erythrocytes and also~     C26:0-lyso-PC in bloodspots.~      Secondary study parameters/outcome of the study (if applicable):~      Secondary outcome parameters are side-effects (subjective and abnormalities in the safety~     lab).~   "
183339|NCT01165047|"~     The primary aim of the study is to evaluate the safety, tolerability and device performance~     of the GeNO nitrosyl delivery system during RHC. Secondary considerations are to confirm that~     inhaled NO generated by the GeNO nitrosyl delivery system, reduces PVR in patients with~     reversible PH, contains levels of NO2 well below the upper level of acceptable exposure.~     Further, the study aims to demonstrate that patient response to inhaled NO can be used as a~     diagnostic tool with which to determine the proper course of medical action in patients with~     chronic heart failure.~      Patients with chronic heart failure accompanied by pulmonary hypertension and increased~     pulmonary vascular resistance have a number of possible medical therapies available to them.~     The least invasive, and therefore most appealing, option is standard management with~     medication and observation. Alternatively, implantation of a left ventricular assist device~     (LVAD) may be considered, either as a permanent solution or as a bridging strategy to the~     final option, orthotopic heart transplantation (OHT). It is often unclear which route is the~     best medical choice, and a tool to help physicians and patients choose between these~     alternatives would be greatly beneficial.~      It has been shown that chronic heart failure patients that demonstrate irreversible pulmonary~     hypertension, even in the presence of vasodilators, exhibit adverse outcomes after OHT (Tsai~     et al., 2002; Ericson et al., 1990; Murali et al., 1996). It follows that patient response to~     pulmonary vasodilators can, and should be used to classify patients as potential candidates~     for OHT. In particular, patient response to inhaled NO, a known pulmonary vasodilator, can be~     used as a diagnostic tool to assist in deciding which medical route to take.~      With this in mind, the current study aims to demonstrate whether or not NO generated by the~     GeNO nitrosyl delivery system effects a reduction in pulmonary hypertension due to increased~     pulmonary vascular resistance in patients with chronic heart failure. Any demonstrated~     ability of inhaled NO to decrease PVR in patients with reversible PH will support the use of~     patient response to inhaled NO as a diagnostic tool to assist in choosing the most~     appropriate medical therapy for patients with chronic heart failure.~   "
183340|NCT01165034|"~     Breathlessness is a common, distressing symptom in advanced malignant and non malignant~     disease, and impacts significantly on quality of life. Breathlessness in end stage disease is~     also responsible for significant healthcare resource usage. Escalante [1] reported hospital~     admission rates of 60% in patients presenting to a cancer treatment centre with~     breathlessness. Preliminary trials of breathlessness clinics with selected groups of patients~     have been promising, but lack data on their cost effectiveness.~      The principal aim of the research is to develop and evaluate the effectiveness and cost~     effectiveness of a multidisciplinary outpatient breathlessness support service (BSS) for the~     palliation of breathlessness, in advanced malignant and non malignant disease. This is a~     phase II study that aims to test the hypothesis that a BSS will improve patient mastery over~     breathlessness and reduce the use of healthcare resources (including GP~     consultations,accident and emergency attendances, and length of hospital stay) compared with~     usual best medical care alone (UC),at an acceptable level of cost effectiveness.The outcomes~     of this study will also help to determine sample size,develop and test methods for a phase~     III trial that will follow on from this project.~      This study will run over 2 years. Breathless patients with advanced malignant and non~     malignant disease who have already been optimally medically managed will be eligible.~      The service will be run in the outpatient department of King's College Hospital, and patients~     will also be assessed in their own home and by telephone interviews. At baseline we will~     assess respiratory function and breathlessness mastery and severity using validated scales,~     and health service usage. Individuals will be randomised to the intervention group [IG]~     (n=55) or UC (n=55). The IG will attend the new outpatient clinical service with~     multiprofessional input. Assessments will be repeated at 4, 10 & 24 weeks.~      1.Escalante, C.P., Martin, C.G., Elting, L.S. et al., Dyspnea in cancer patients. Etiology,~     resource utilization, and survival implications in a managed care world. Cancer, 1996. 78(6):~     p. 13149.~   "
183341|NCT01165021|"~     The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin~     can reduce tumor size.~   "
183342|NCT01165008|"~     To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients~     with treatment-resistant inflammatory myopathies.~      Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis~     (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per~     day during 12 months. Outcome measures included myositis disease activity score with~     improvement defined according to The International Myositis Assessment and Clinical Studies~     Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition~     repeat muscle biopsies were performed~   "
183343|NCT01164995|"~     The purpose of this study is to determine if patients with p53 mutated epithelial ovarian~     cancer that have been treated with first line treatment (paclitaxel - carboplatin combination~     therapy) and that have shown early relapse (within 3 months) or progression during treatment~     will benefit from treatment with Wee-1 inhibitor MK-1775 and carboplatin.~   "
183345|NCT01164969|"~     The purpose of this study is to determine whether mixed H. pylori strain infection is the~     reason for eradication failure during treatment of H. pylori infection. The investigators~     present the results got from extensive sampling of biopsy samples taken from individuals~     diagnosed with H. pylori connected disease. The investigators were looking for individuals~     that were not able to eradicate H. pylori although they had susceptibility testing tailored~     antibiotic therapy. On their control visit after 2 months they presented again with H. pylori~     although at their first visit they had H. pylori isolated from biopsy sample sensitive to all~     antibiotics prescribed. Multi Locus Sequence Typing (MLST) was used to prove the sequence~     type of H. pylori and E test was used to determine susceptibility of H. pylori to~     antibiotics.~   "
183346|NCT01164956|"~     The overall aim of this pilot study is to conduct a combined N-of-1 trial (N-1-T) of MPH~     (methylphenidate) for amelioration of fatigue in children with cancer, and to evaluate the~     N-1-T design both for individual clinical decision making and for clinical trials in symptom~     management in pediatric oncology patients.~   "
183347|NCT01164943|"~     Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of~     egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone~     on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these~     stimulation protocols, there will be a negative effect on the successful rates in the egg~     donation cycles. The aim of this study is to observe if there is a different in aneuploidy~     rate and morphological oocyte parameters between different stimulation protocols.~   "
183348|NCT01164930|"~     The purpose of this randomized controlled trial is to evaluate the effectiveness of an~     empirically supported psychosocial treatment, Acceptance and Commitment Therapy, in~     facilitating improved quality of life, benefit-finding, and cortisol rhythm in breast cancer~     patients in an outpatient clinical oncology setting.~   "
183349|NCT01164917|"~     This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover~     study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to~     receive AMG 811 and placebo in one of two sequences (ie, AMG 811 followed by placebo or~     placebo followed by AMG 811).~   "
183350|NCT01164904|"~     To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses~     of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate~     ulcerative colitis (UC)~   "
183351|NCT01164891|"~     This open-label, non-randomized study will assess the mass balance, metabolism, routes and~     rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032)~     in previously treated or untreated patients with metastatic melanoma. Patients will receive~     continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be~     administered. Anticipated time on study treatment is until disease progression occurs.~   "
183352|NCT01164878|"~     Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by~     early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis~     (PNAC).~      Extreme low birth weight infants (ELBW, birth weight < 1000 g) are at increased risk for~     development of PNAC.~      Important factors implicated in the aetiology of PNAC are high caloric parenteral nutrition~     using amino acids or dextrose, but also intravenous lipids and infections in particular~     necrotizing enterocolitis (NEC).~      Due to a change of paradigm a more aggressive nutrition with early use of parenteral amino~     acids/lipids and early fortification of mothers milk or alternatively high caloric preterm~     formula is warranted. Accordingly - in line with the existing expert opinion and evidence -~     the feeding policy at the neonatal care units of our hospital was adapted.~      Evidence exists that PNAC might be caused by the use of high concentrations of amino acids~     and lipids in parenteral nutrition. Furthermore NEC is associated with high osmotic feeds.~     Therefore the incidence of PNAC might be increased directly and indirectly after introducing~     the new feeding policy.~      The investigators therefore aim at retrospectively investigating the incidence of PNAC before~     and after introduction of a feeding policy of aggressive nutrition for ELBW infants.~   "
183353|NCT01164865|"~     The purpose of this study was to assess comfort in soft contact lens wearers.~   "
183354|NCT01164852|"~     How best to manage preeclampsia remote from term is controversial because of conflicting~     maternal and neonatal risks. Gestational age is the most important determinant of neonatal~     outcome. There are two basic approaches when delivery is not clear indicated by assessment of~     maternal and fetal well-being. The interventionist care when the delivery is planned within~     48 hours and the expectant care which refers to pregnancy prolongation during which time~     women and fetuses are carefully monitored for indications for delivery.~      The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs~     interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of~     gestation.~   "
183355|NCT01164839|"~     The multicenter study evaluates the diagnostic performance of coronary Computed Tomography~     Angiogram (CTA) with multi-slice computed tomography (MSCT) in comparison with X-ray coronary~     angiography and the factors affecting the accuracy of coronary CTA in diagnosing stenosis of~     coronary arteries. Furthermore, the study tends to establish the standard of image quality~     and associated factors that may ensure accurate diagnosis of coronary stenosis with coronary~     CTA.~   "
183356|NCT01164826|"~     The purpose of this study is:~        -  To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg~          tablets in healthy, adult, human subjects under fed conditions with a washout period of~          16 days.~        -  To monitor adverse events and ensure the safety of subjects.~   "
183357|NCT01164813|"~     The purpose of this study is:~        -  To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg~          tablets in healthy, adult, human subjects under fasting conditions with a washout period~          of 14 days.~        -  To monitor adverse events and ensure the safety of subjects.~   "
183358|NCT01164800|"~     The purpose of this study is~        -  To compare the single oral dose bioavailability of test product, Trandolapril 4 mg~          Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult,~          human subjects, under fed conditions to assess bioequivalence.~        -  To monitor adverse events and ensure safety of subjects.~   "
183380|NCT01164501|"~     This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic~     patients with renal impairment in order to provide these data for approval for BI 10773 as an~     antidiabetic agent by regulatory authorities.~   "
183359|NCT01164787|"~     The purpose of this study is~        -  To compare the single oral dose bioavailability of test product, Trandolapril 4 mg~          Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult,~          human subjects, under fed conditions to assess bioequivalence.~        -  To monitor adverse events and ensure safety of subjects.~   "
183360|NCT01164774|"~     The purpose of this study is~        -  To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to~          that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under non-fasting~          conditions and to assess the bioequivalence.~        -  To monitor the safety of the subjects.~   "
183361|NCT01164761|"~     The purpose of this study is~        -  To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to~          that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under fasting~          conditions and to assess the bioequivalence.~        -  To monitor the safety of the subjects.~   "
183362|NCT01164748|"~     Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated~     with regional lymph node status. Therefore, axillary staging may be warranted in patients~     with recurrent disease and intact axillary nodes, although this has not been described in~     guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been~     changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be~     detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate~     staging.~      Objective: To assess the technical feasibility of lymphoscintigraphy after prior breast~     surgery. A second goal is to investigate whether or not previous breast surgery (with or~     without radiotherapy) significantly changes the lymphatic drainage pathways of the breast.~   "
183363|NCT01164735|"~     This research study is studying biomarkers in tissue samples from patients with stage III,~     stage IV, or recurrent endometrial cancer. Studying samples of tumor tissue from patients~     with cancer in the laboratory may help doctors learn more about changes that occur in~     deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.~   "
183364|NCT01164722|"~     RATIONALE: Infrared coagulator ablation may be effective in preventing the development of~     anal cancer in patients with anal neoplasia~      PURPOSE: This randomized phase III trial is studying infrared coagulator ablation to see how~     well it works compared to observation in preventing anal cancer in HIV-positive patients with~     anal neoplasia.~   "
183365|NCT01164709|"~     RATIONALE: Nelfinavir mesylate and bortezomib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Bortezomib may also stop the growth of~     hematologic cancer by blocking blood flow to the cancer. Giving nelfinavir mesylate together~     with bortezomib may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate~     when given together with bortezomib in treating patients with relapsed or progressive~     advanced hematologic cancer.~   "
183366|NCT01164696|"~     The objective of this study is to compare hematological toxicity, costs, health-related~     quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin~     Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement~     on the basis of a clinical trial in heavily pre-treated NHL.~   "
183367|NCT01164683|"~     Obstructive sleep apnea (OSA) is a highly prevalent condition in veterans with some estimates~     as high as 47%. Poor adherence to the primary treatment of OSA -- continuous positive airway~     pressure (CPAP) therapy - is associated with increased risk for heart attacks, strokes and~     even death. The investigators plan to improve CPAP adherence in veterans through their~     interactions with peers who have successfully adopted CPAP therapy.~      Such peer-buddies may promote the well-being of veterans while remaining highly~     cost-effective when compared to healthcare providers. Our strategy is grounded on the~     rationale that veterans as a group are ecoculturally more homogenous than expected for the~     given level of differences in age, gender, ethnicity, or socioeconomic strata. Our long-term~     objectives are to initiate a larger, multi-site, research study for enhancing CPAP adherence~     in veterans with OSA. The ultimate goal of this research is to develop a cheap, effective and~     exportable system of care to promote CPAP adherence in patients with OSA.~   "
183368|NCT01164670|"~     Sarcopenia, the age-related decline in muscle mass and function (widely recognized as~     frailty), is increasingly being appreciated, primarily in the research environment.~     Interventions to prevent or treat sarcopenia can be anticipated to reduce falls, fractures~     and thereby to facilitate independence and improve quality of life for older adults.~     Unfortunately, there is no current consensus definition of sarcopenia, thereby impeding~     clinical recognition and treatment. It has been advocated that low appendicular (arm and leg)~     lean mass, as measured by DXA, be utilized as a clinical diagnostic tool to define~     sarcopenia. While such an approach is possible, however, muscle strength loss is more rapid~     than mass loss, indicating deterioration of muscle quality. Muscle quality may be affected~     by changes at the neuromuscular, cellular or subcellular levels; parameters not detected by~     measuring mass alone. Clearly, tools evaluating muscle performance, not simply mass, are~     needed to optimally identify, and subsequently monitor, treatment of older adults with~     sarcopenia. While current tests of muscle power/function (e.g., chair-rising, self-selected~     gait velocity, etc.) do correlate with functional limitation in older adults, these existing~     tests have limitations in that they cannot be performed in all people, may have yes/no~     results rather than a continuous scale and may not be highly precise. Thus, improved muscle~     function assessment tools are needed, both clinically and in research venues. Jumping~     mechanography is very likely one such methodology.~   "
183381|NCT01164488|"~     This non-randomized, open-label study will evaluate the interaction of~     RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability~     in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole~     alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time~     on study treatment is 25 days.~   "
183382|NCT01164475|"~     The purpose of this study was to compare the responses of 2 different doses of plerixafor in~     patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.~   "
183383|NCT01164462|"~     Objective: This research agreement brings together French and Canadian teams of scientists,~     HIV testing centers and community based partners. The aim is to explore the feasibility and~     limitations of offering community based rapid HIV testing to men who have sex with men (MSM).~   "
183369|NCT01164657|"~     Background:~      The World Health Organization (WHO) advises against recumbent or supine position for longer~     periods during labour and birth and states that caregivers should encourage and support the~     woman to take the position she finds most comfortable. It has been suggested that upright~     positions may improve childbirth outcomes and reduce the risk for instrumental delivery.~      Objective:~      The primary objective was to test the hypothesis that birthing on the BirthRite ® seat will~     result in a reduction in the number of primiparous women delivered instrumentally.~      Method:~      A power calculation showed (α = 0.05 β = 0.2) a requirement of 460 participants in each of~     the two arms of the trial in order to test for a 40% reduction (from 15% to 9%) of~     instrumental deliveries in primiparous women at a maternity unit in southern Sweden. It was~     decided to subject the study to a feasibility test by conducting a pilot-study in which 68~     women were randomised to give birth on the birthing seat or to give birth in any other~     position but on the BirthRite ® seat. Randomization to birth on the birthing seat or in any~     other position took place when the participant's cervix was fully dilated. The primary~     outcome measurement was the number of instrumental deliveries. Secondary outcome measurements~     included oxytocin augmentation, perineal trauma, and blood loss administration of oxytocin~     for augmentation of labour, length of the second stage of labour, perineal trauma, perineal~     oedema, maternal blood loss and haemoglobin, apgar scores, cord pH and transfers to the~     Neonatal Intensive Care Unit(NICU).~   "
183370|NCT01164644|"~     Arnica montana is a homeopathic drug that is made in accordance with the official methods of~     the Homeopathic Pharmacopoeia of the United States (HPUS) and is commonly used by cosmetic~     surgeons throughout the world, although there is no study proving its benefit after~     rhinoplasty surgery. The purpose of the research is to see if Arnica montana will reduce the~     amount of bruising and the intensity of the bruising after surgery. Photographs of the~     subject's face will be taken and used to analyze bruising after rhinoplasty surgery in~     subjects who receive Arnica montana and compare them to photographs of subjects who take a~     placebo (sugar pill).~   "
183371|NCT01164631|"~     Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The~     consequences of these features can include deviation of normal craniofacial growth such that~     this may result in a facial morphology more suitable to the development of sleep apnea later~     in life. The aim of this study was to compare the growth redirection, the evolution of~     respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils~     from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new~     protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and~     proper tongue positioning on swallowing , that together may be helpful on remodeling the~     upper airways.~   "
183372|NCT01164618|"~     The purpose of this study is to assess the effects of repeated RIPC and exercise, on exercise~     performance, skeletal muscle responses and circulating cellular and humoral biology in humans~   "
183373|NCT01164605|"~     The substitution of raltegravir for the NRTIs will result in some reversal of the long term~     adverse effect of lipodystrophy (specifically peripheral lipoatrophy) that is associated with~     the chronic use of NRTIs. Changing the HAART regimen in patients with a sustained virological~     response from a PI plus NRTI to a regimen of the PI plus raltegravir will likely result in~     continued virologic efficacy.~   "
183374|NCT01164592|"~     The purpose of this study is to assess changes in left ventricular performance using~     echocardiography as well as ventricular remodelling, changes in sleep and changes in mood,~     anxiety and cognitive functions occurring as a result of treatment of predominant central~     sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to~     optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF~     study.~   "
183375|NCT01164579|"~     Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early~     rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate~     naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by~     magnetic resonance imaging, x-rays and by standard clinical assessment.~   "
183376|NCT01164566|"~     Brief Summary:~      RATIONALE: Comparing results of diagnostic procedures, such as esophagoscopy, done before and~     after radiation therapy and/or chemotherapy may help doctors predict a patient's response to~     treatment and help plan the best treatment.~      PURPOSE: This clinical trial is studying esophagoscopy in evaluating treatment in patients~     with stage I-IV head and neck cancer who are undergoing radiation therapy and/or~     chemotherapy.~   "
183377|NCT01164553|"~     The purpose of this study is to evaluate the possibility that giving an increased dose of flu~     vaccine to children 6 through 35 months of age will improve protection against influenza~     without increasing side effects. Investigators will evaluate the body's response to the~     vaccine. Male and female participants' ages 6-35 months, who have never received flu vaccine,~     and those ages 12-35 months, who have been previously vaccinated, will participate in the~     study for about 7 months. Vaccine naïve study participants will receive two doses of flu~     vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Previously vaccinated~     subjects will receive one dose of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL~     dose (Group 2). Study procedures include physical examination, memory aids, blood sampling~     and a follow-up phone call about 6 months after the last vaccine dose.~   "
183378|NCT01164540|"~     This study evaluates whether treatment with rosuvastatin on top of standard anti-coagulant~     treatment will decrease the risk of recurrent venous thromboembolism and arterial~     thromboembolic events in patients with previous deep vein thrombosis or pulmonary embolism.~   "
183379|NCT01164514|"~     The purpose of this study is to test the safety of an experimental vaccine against sepsis~     (infection of the blood) alone and with an experimental adjuvant (a substance that may~     improve vaccine effectiveness). This study will also find out how well antibodies are made~     after receiving vaccine alone or vaccine combined with adjuvant. Participants will include up~     to 34 healthy volunteers between the ages 18-50 years. Participants will be randomly assigned~     to 1 of 4 groups to receive vaccine alone, vaccine with adjuvant (2 different dosages) or~     placebo (inactive substance). Participants will receive 3 vaccinations at different times~     during the study (Day 0, Day 29 and Day 59). Study procedures will include blood samples,~     urine samples, electrocardiogram (measures heart activity) and a completion of a memory aid~     to document side effects. Participation will involve 16 clinic visits and 3 follow-up~     telephone calls over 12 months.~   "
183384|NCT01164449|"~     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.~     Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of~     the intensive care unit staff difficulties were experienced in achieving efficient and safe~     glucose control. A fully automated algorithm may help to overcome some of these limitations~     by excluding intuitive interventions and integrating relevant clinical data in the~     decision-making process. Space GlucoseControl (TGC system) is a decision support system which~     helps to achieve safe and reliable blood glucose control in the desired ranges. Information~     on parenteral and enteral nutrition is automatically integrated into the calculations. The~     primary objective of the current study is to investigate the performance and usability of the~     Space TGC system for glucose control in medical ICU patients.~   "
183385|NCT01164436|"~     The incidence of lymphomas is increased among HIV infected patients. In 70 % of cases, those~     are Non Hodgkin's lymphomas (NHL) and Hodgkin lymphomas (HL) in 30% of cases. In France,~     their incidence is estimated to 100 cases per year (data from the Base de données~     Hospitalière Française sur l'Infection à VIH (FHDH)). The main mechanisms involved in~     lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (Epstein-Barr (EBV)~     and HHV8) and molecular oncogenic events. A better understanding of these different pathways,~     give the possibility to design specific treatments. The treatment of these lymphomas is not~     standardized. A prospective study of patients with HIV associated lymphoid malignancies is an~     innovating tool to answer epidemiological, physiopathological and therapeutic questions. We~     propose a prospective multicentric study of these patients.~      The main objectives of this prospective study are to:~        -  evaluate the incidence, characterise clinically and histologically NHL and HL cases~          associated to HIV~        -  perform an observational study of the treatment and outcome of these patients out of the~          context of clinical trials,~        -  study the differentiation and activation of B-cell populations,~        -  better understand the role of specific T cell responses in the control of EBV infection,~        -  allow other biological studies from the ANRS group  Lymphome et VIH .~      The recruitment of 40 cases per year is expected. The length of inclusions is 7 years. The~     follow-up will be of 2 years. Clinical, pathological and biological data at diagnosis and~     during follow-up will be collected. This will allow characterizing the lymphoma, the HIV~     infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be~     centralized to collect cell, DNA, RNA, plasma, serum and tumour collections (Y.Taoufik, S~     Prevot* ). To better understand the EBV infection and lymphomagenesis in HIV infection, we~     propose to follow the viral load and the molecular characteristics of EBV in PBMC, plasma and~     tumour (P.Morand* , V.Boyer* ), to investigate the EBV-T cell responses (G.Carcelain) and the~     presence and reactivation of EBV in peripheral B cells (C.Amiel* , JC Nicolas) and in tumoral~     samples (M.Raphael* , I.Joab* ). The other mechanisms of lymphomagenesis in HIV infection~     will be studied by the analysis of the sub-populations of B-cells in terms of activation and~     differentiation (Y.Taoufik) and by the characterization of MSI tumours (A.Duval).~   "
183386|NCT01164423|"~     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.~     Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of~     the intensive care unit staff difficulties were experienced in achieving efficient and safe~     glucose control. A fully automated algorithm may help to overcome some of these limitations~     by excluding intuitive interventions and integrating relevant clinical data in the~     decision-making process. Space GlucoseControl (TGC system) is a decision support system which~     helps to achieve safe and reliable blood glucose control in the desired ranges. Information~     on parenteral and enteral nutrition is automatically integrated into the calculations. The~     primary objective of the current study is to investigate the performance and usability of the~     Space TGC system for glucose control in medical ICU patients.~   "
183387|NCT01164410|"~     Bowel preparation solutions containing Polyethylene Glycol is a commonly used preparation of~     the colon for colonoscopy in children. However young children and adolescents often subject~     to the volume and taste of liquid that must be consumed for an adequate preparation.~     Currently almost all of our patients experience some difficulty with completing the colyte~     preparation and approximately 10-20% is unable to achieve adequate cleansing due to inability~     to drink the solution. The standard colyte solution is salty and often impedes children from~     drinking the required amount of colyte preparation for adequate colon cleansing. Miralax has~     been used at a dose of 1.5gm/kg/day to a maximum of 102 gms /day as four day prep Four day~     bowel prep can be extremely frustrating for the parents and the patients. This may result in~     low patient acceptance, limiting compliance leading to inadequate colonoscopy. Decreasing the~     duration of the prep may increase the compliance and provide better colon visualization.~      Hence a Cross sectional study looking at the safety,efficacy,tolerability of PEG 3350 mixed~     in Gatorade G(TM) as a bowel prep in children needs to be conducted. Consent will be obtained~     from parents and assent will be obtained from patients. Previous laboratory tests for each~     patient will be reviewed. All patients in the study will be required to consume~     MiralaxTM/Gatorade GTM the day prior to their procedure. The patients will be given written~     instructions as to how to much solution to take and how to prepare and consume the solution.~     The patient shall be maintained on a clear liquid diet the day prior to the procedure. Once~     patients arrive for the colonoscopy they will be asked to complete a questionnaire regarding~     their bowel preparation. Prior to the administration of IV fluids, 1ml of blood will be~     obtained a basic metabolic panel. The patient will then undergo a colonoscopy by routine~     procedure and technique. The endoscopist will complete a questionnaire when done with the~     colonoscopy to rate the cleanliness of the colon.~      We propose that MiralaxTM combined with Gatorade GTM given the day prior to colonoscopy is a~     safe, tolerable and efficacious cleansing regimen for colonoscopy in children.~   "
183388|NCT01164397|"~     The aim of this study is to evaluate the effectiveness of Rosuvastatin versus~     Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.~   "
183389|NCT01164384|"~     Erstes Safety Trial mit Baminercept in chronischen HCV Patienten. Untersuchung des potentiell~     antiviralen, antiinflammatorischen Effekts sowie Modulation der hepatischen Gen-Expression.~      10 Patienten, open label, 10 Wochen Therapie. Sequentielles Enrollement der ersten 4~     Patienten.~        -  Trial with medicinal product~   "
183390|NCT01164371|"~     The initial manifestation of symptomatic coronary disease can range from angina (or symptoms~     of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better~     understanding of gender differences in initial presentation of coronary disease and the rate~     and predictors of progression to subsequent stages in coronary disease could help to identify~     which gender- specific factors might reduce or slow transition to more serious disease states~     and improve outcomes. The investigators' research focuses on the role primary care management~     of cardiovascular risk factors plays in gender differences in the progression to subsequent~     disease states and to mortality.~   "
183391|NCT01164358|"~     This study is a prospective, open, not randomized, unilateral multicenter eye study~     consisting of two study arms to observe the long term satisfaction of patients after an~     INTRACOR treatment. The satisfaction is determined with the help of the patient perception~     and the subjective / objective diagnostic data.~      The hypothesis of the study is that patients after an INTRACOR treatment are satisfied in the~     long term.~   "
183392|NCT01164345|"~     The aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF~     (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL)~     patients for autologous transplantation.~   "
183427|NCT01163890|"~     The Work and Health Initiative (WHI) trial is testing an innovative, community-based program~     that provides mental health and vocational services to workers 50 years or older to improve~     functioning and reduce productivity loss. The purpose of this study is to test the hypothesis~     that relative to usual care, the WHI improves the work outcomes of depression and reduces~     depression-related productivity loss.~   "
183428|NCT01163877|"~     The aim of this study is to investigate the change in iron metabolism in relation to malaria~     and helminth infections using a stable isotope technique.~   "
183393|NCT01164332|"~     The disposition of NRL972 after a 15-second intravenous injection of 2 mg NRL972 is~     distinctly slower in patients with hepatic cirrhosis and acute hepatitis than in healthy~     control subjects. NRL972 appears to be a suitable investigational marker of hepatic~     transporter clearance dysfunction.~      Although the pharmacokinetics of NRL972 provide a reliable differentiation between subject~     groups, this approach relies on precisely timed sampling of venous blood, cautious~     preparation, handling and on-site storage of plasma samples, the transfer of samples to a~     central laboratory for analysis, and the availability of a validated assay procedure.~      For these reasons, there is interest in developing and validating alternative methods for~     determining the concentration of NRL972 in venous blood. Two such methods have been developed~     to date, but their utility in determining NRL972 pharmacokinetics has yet to be established.~   "
183394|NCT01164319|"~     The aim of this study is to identify the most appropriate method for managing patients with~     AF recurrences after the first ablation procedure, through the diagnostic data stored by a~     subcutaneous AF monitor.~   "
183395|NCT01164306|"~     The purpose of this randomized control trial is to evaluate the effects of a multi-component~     intervention aimed at:~        1. preventing tobacco initiation in youth~        2. promoting anti-tobacco socialization in the home~        3. decreasing environmental tobacco smoke exposure in children~        4. promoting successful cessation in parent/guardian smokers.~      Control arm participants receive general health education. This family-based approach is~     implemented with school systems as the primary point of entry.~   "
183396|NCT01164293|"~     Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal~     symptoms~   "
183397|NCT01164280|"~     Objectives: To evaluate the effect of pulse rate changes on the clinical response and~     stimulation related pain symptoms in sacral neuromodulation (SNM) treatment.~      Materials and Methods: This pilot study evaluated the effect of 4 different pulse rates~     (5.2Hz-10Hz-21Hz-40Hz) in patients with suboptimal response to SNM. The effect of each~     frequency was evaluated over test period of 6 days. To avoid carry over effect, stimulation~     was kept off for 24 hours between consecutive test periods. The last 3 days of every test~     period, a voiding diary (VD) and questionnaire was filled in. The changes on clinical~     response and pain symptoms were compared between the four pulse-rates using multivariate~     analysis.~      Results: Fifty patients were included of which 40 (80%) were female. Mean age was 55.5yr (SD~     12.3). Forty-one patients (82%) had overactive bladder symptoms and 9 (18%) had chronic~     non-obstructive urinary retention. No significant difference was found regarding clinical~     outcome (VD and questionnaire) between the different pulse rates. Furthermore, none of the~     four pulse rates was significantly related to the occurrence of SNM-related pain. However, on~     individual basis, patients appear to benefit from changing the pulse rate concerning both~     treatment efficacy and stimulation related pain.~      Conclusions: On group level, none of the four pulse rates in this study appears to have a~     significantly different effect on clinical outcome or SNM-related pain. However, a~     tailor-made approach for optimizing treatment efficacy by changing the pulse rate might be~     useful.~   "
183398|NCT01164267|"~     This is a multicenter open-label uncontrolled phase II study. There are no previous clinical~     data to estimate the expected response rate of everolimus in MALT lymphomas and in the other~     less common MZLs (i.e. nodal and splenic) refractory or relapsing after at least 1 prior~     systemic treatment (chemotherapy or immunotherapy).~      The primary objective of this study is to define the antitumor activity, in term of overall~     response rate (ORR), as sum of complete remissions (CR) and partial remissions (PR) of~     everolimus in relapsed or refractory marginal zone B-cell lymphomas.~      The secondary objectives of this study are to assess safety, as acute or long-term toxicity,~     response duration (RD) (time to relapse or progression) in responders and progression-free~     survival (PFS) (time to disease progression or death from any cause) in all patients.~   "
183399|NCT01164254|"~     In spite of long-standing hypothesis relating diet and physical activity to several cancers,~     diet and physical activity-cancer associations have been modest at best and often~     inconsistent in epidemiologic studies. Investigators around the world have become~     increasingly concerned that error in the measurement of both diet and physical activity is~     compromising our ability to detect these important but modest associations. Most commonly~     used diet and physical activity assessment methods have been based on a relatively small set~     of questions (e.g. 124 food items consumed or 5-10 physical activities in the past 12~     months). Recent developments in computer technology provide an opportunity to use~     internet-based instruments to assess an individual s diet and physical activity more~     accurately and cost effectively.~   "
183400|NCT01164241|"~     Background:~      - Allergic inflammation is central to allergy-related diseases and disorders, such as asthma,~     food allergies, and atopic dermatitis. Atopic dermatitis, commonly called eczema is a~     chronic, noncontagious skin condition, usually starting in the first years of life, which~     causes itching and scaling of an individual s skin. Because atopic dermatitis is a common~     condition in children who have allergy-related diseases, including asthma, researchers are~     interested in studying both individuals with atopic dermatitis and their close relatives~     (parents and children) to better understand how allergy-related diseases develop and~     progress. In addition, some patients with inherited disorders with features including atopic~     dermatitis or other aspects of allergy such as food allergy, asthma, hay fever, hives, and~     others, will also be seen.~      Objectives:~      - To study the natural history of diseases of allergic inflammation, such as atopic~     dermatitis or genetic disorders associated with allergic inflammation.~      Eligibility:~        -  Children and adolescents between 1 month and 21 years of age who have a documented~          history of moderate to severe atopic dermatitis.~        -  Individuals between 1 month and 80 years of age who have a suspected genetic or~          inherited allergy disorder related to atopic dermatitis or allergic pathways.~        -  Child and adult relatives of eligible participants will also be studied on this~          protocol.~      Design:~        -  The study will require one initial visit to the National Institutes of Health Clinical~          Center (lasting 1-5 days), as well as any required follow-up visits for treatment and~          research studies. Participants will receive treatment for atopic dermatitis and other~          allergic diseases as part of the study for up to 1 year.~        -  Participants will have some or all of the following tests as part of this study:~        -  A detailed physical examination and medical history~        -  Allergy skin prick testing to examine participants' responses to different allergens.~        -  Blood samples for additional allergen testing, testing the immune system, and other~          research purposes~        -  Skin punch biopsy to take a skin sample~        -  Lung function tests to measure airflow from the lungs and inflammation~        -  Food-related tests to diagnose potential food allergies~        -  Leukapheresis to collect white blood cells only~        -  Research samples, including stool specimens, saliva samples, buccal swabs (to collect~          cells from the inside of the cheek), and skin cell samples~        -  Clinical digital photography to provide images of affected and healthy skin.~        -  Participants will be asked to return for follow-up visits and tests for up to 1 year~          after the initial visit(s).~   "
183438|NCT01163747|"~     This randomized, parallel-group, open-label study will evaluate the effect of Actemra~     (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an~     inadequate response to methotrexate and who have had an inadequate clinical response or were~     intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.~   "
191558|NCT01056991|"~     This study will determine if modern under-patient warming mattresses are as effective as~     forced air warming blankets in preventing cold and shivering in patients scheduled for non~     emergency surgery.~   "
183401|NCT01164228|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or~     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet~     known whether giving sunitinib malate and gemcitabine hydrochloride together is more~     effective than sunitinib malate alone in treating patients with kidney cancer.~      PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together~     with or without gemcitabine hydrochloride to see how well they work in treating patients with~     advanced kidney cancer that cannot be removed by surgery.~   "
183402|NCT01164215|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin~     calcium, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy,~     may kill more tumor cells. Studying samples of blood in the laboratory from patients with~     cancer receiving fluorouracil in combination with oxaliplatin and leucovorin calcium may help~     doctors learn how fluorouracil works in the body and how patients will respond to treatment.~      PURPOSE: This phase I trial is studying biomarker-guided fluorouracil in treating patients~     with colorectal cancer receiving combination chemotherapy.~   "
183403|NCT01164202|"~     RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and~     keeping anticancer drugs near the tumor. Sunitinib malate may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the~     tumor. It is not yet known whether chemoembolization is more effective with or without~     sunitinib malate in treating patients with liver cancer.~      PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization~     of the liver and to see how well in works when given together with or without sunitinib~     malate in treating patients with liver cancer.~   "
183404|NCT01164189|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. It is not yet known whether temozolomide is~     more effective when given with or without bevacizumab in treating patients with recurrent~     glioma.~      PURPOSE: This randomized clinical trial is studying how well temozolomide works with or~     without bevacizumab in treating patients with recurrent glioma.~   "
183405|NCT01164176|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with~     locally advanced or metastatic thyroid cancer.~   "
183406|NCT01164163|"~     RATIONALE: INCB18424 (Ruxolitinib) may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~      PURPOSE: This phase 1 clinical trial is studying the side effects and best dose of INCB18424~     in treating young patients with relapsed or refractory solid tumor, leukemia, or~     myeloproliferative disease.~   "
183407|NCT01164150|"~     Post-operative radiotherapy is internationally accepted as standard practice in the~     management of high-risk endometrial cancer1. Whilst it has no proven impact on overall~     survival it significantly increases local control.~      Conventional radiotherapy techniques (3-dimensional) utilise a 3 or 4 field beam arrangement~     to target the pelvis in order to treat those areas at risk of recurrence: the vagina, the~     parametrium and the pelvic lymph nodes. However, when using such a technique it is not~     possible to avoid irradiating sensitive normal tissues such as the bowel and bladder.~      Toxicity data from international randomised control trials in endometrial cancer report~     significantly more haematological, gastrointestinal, genitourinary and cutaneous toxicites~     (all grades) in those who received pelvic irradiation compared to those who did not2,3. These~     trials delivered radiotherapy using 2 or 3-dimensional techniques.~      Intensity Modulated Radiation Therapy (IMRT) is a newer but established radiotherapy~     technique in many tumour sites that allows us to much more tightly conform the radiation. It~     uses computer-generated beams to produce radiotherapy volumes that can avoid irradiation of~     normal tissues in the pelvis.~      There are no randomised studies reported in the literature that compare 3-dimensional pelvic~     irradiation with IMRT in patients who have had surgery for endometrial cancer. However there~     are several small studies that report considerable sparing of normal tissues using IMRT and~     when compared retrospectively with conventionally treated patients demonstrate marked~     reductions in acute gastrointestinal and genitourinary toxicity4.~      By delivering post-operative radiotherapy to the pelvis using IMRT (as opposed to the~     standard 3-dimensional technique) it is anticipated that whilst local control and survival~     will be unaffected acute and late toxicity will be reduced.~   "
183408|NCT01164137|"~     This initiative aims to decrease the risk of medication errors at the hospital-community~     interface as well as health system utilization following hospital discharge by implementing a~     pharmacist-led medication reconciliation in the patients' home within 72 hours of hospital~     discharge.~   "
183409|NCT01164124|"~     The overall purpose of this research is to test whether adding a supplement to the feeding of~     extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will~     help him/her achieve full feeding faster and achieve better weight gain.~   "
183410|NCT01164111|"~     Purpose:~      The purpose of this study is to determine the effect of pre operative resistance training on~     subjects scheduled for total hip arthroplasty due to primary osteoarthritis.~      Background:~      Decreasing performance with age due to age related muscle loss is well known. Resistance~     training in elderly has shown significant effect in regaining both muscle force and function.~      It has been shown that a chronic condition with limitations in function as seen in~     osteoarthritis of the hip decreases both muscle performance and size.~      Studies of resistance training of the hip related muscle groups in the early postoperative~     period after total hip arthroplasty have shown significant effect on muscle force and~     function.~      Few studies have investigated preoperative intervention, all with lighter types of training~     such as water pool training.~      The effect of preoperative resistance training on subjects with primal osteoarthritis of the~     hip is yet to be described.~      Study hypothesis:~      Preoperative resistance training will significant improve outcomes on both primal and~     secondary effect parameters pre surgery and at 1 year followup.~   "
183439|NCT01163734|"~     Patients with CAD and clinical symptoms of heart failure or patients with suspected heart~     failure with preserved ejection fraction (HFpEF) will be enrolled. Study drug will be given~     as continuous IV infusion followed by oral treatment for 13 days. LV pressures and~     hemodynamic data will be measured prior to and after administration of study drug. In~     addition, Doppler ECHO, cardiopulmonary exercise testing (CPET), and NT-pro-BNP determination~     will be performed. Adverse events and safety labs will be collected and monitored.~   "
183411|NCT01164098|"~     The investigators propose to study novel targets of rituximab in podocytes, with a particular~     focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong~     clinical implications, since it may extend the approved indications for rituximab treatment~     to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new~     insights into the role of sphyngomyelin related enzymes in podocyte function in health and~     disease, thus allowing the identification of novel targets for antiproteinuric drug~     development. Finally, the proposed study offers the opportunity to identify a correlation~     between the patient's specific clinical outcome and the experimental results obtained after~     exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may~     lead to the development of an assay for the pre-transplant identification of patients at~     high-risk for recurrent disease and, among them, may allow the identification of those~     patients that will respond to rituximab.~   "
183412|NCT01164085|"~     Intraocular delivery of ketorolac will be an effective means to treat inflammation and~     macular edema and prevent structural complications and vision loss in patients with uveitis~     who are unable to tolerate corticosteroids due to their side effects.~   "
183413|NCT01164072|"~     The study's major aim is to investigate the ability of a commercial Electronic Nicotine~     Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers~     unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and~     cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.~      The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms,~     and adverse events of a currently marketed device in Italy (Categoria electronic cigarette~     - ORIGINAL 7.2 mg nicotine cartridges).~      The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction~     or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.~   "
183414|NCT01164059|"~     This study is designed to compare the efficacy and drug tolerability of two strategies for~     the treatment of schizophrenia. The two strategies consist of utilizing, on the one hand, a~     conventional antipsychotic like haloperidol or flupentixol and, on the other hand, a newer~     antipsychotic compound like olanzapine, quetiapine or aripiprazole in patients with~     schizophrenia.~   "
183415|NCT01164046|"~     Background~      Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism~     (venous thromboembolism, VTE) are generally treated with low molecular weight heparin~     (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of~     recurrent VTE compared to vitamin K antagonists (VKA). It is recommended that patients with~     active malignancy (metastatic cancer and/or ongoing cancer treatment)continue anticoagulant~     treatment. However, it is unknown whether LMWH is still superior compared to VKA for the~     long-term anticoagulant treatment.~      Aim~      The aim of this study is to evaluate whether low-molecular-weight heparin more effectively~     reduces recurrent VTE compared to vitamin K antagonists in patients with cancer who have~     already completed 6 to 12 months of anticoagulant treatment because of deep venous thrombosis~     of the leg or pulmonary embolism.~      Hypothesis~      The investigators hypothesize that LMWH is more effective compared to VKA in the long-term~     treatment of VTE in cancer patients who have already been treated for 6-12 months with~     anticoagulants.~      Design~      This is a multicenter, multinational, randomized, open label trial.~      Patients~      Patients with a malignancy (all types, solid and hematological) who have received 6-12 months~     of anticoagulation for VTE and have an indication for continuing anticoagulation, will be~     randomly assigned to six additional months of LMWH or VKA. LMWH will be administered in a~     weight-adjusted scheme, with 65-75% of therapeutic doses. All types of LMWH and VKA are~     allowed, as long as weight adjusted dosing is possible for LMWH. The target INR will be~     2.0-3.0. The primary efficacy outcome is symptomatic recurrent VTE, i.e. deep vein thrombosis~     and pulmonary embolism. The primary safety outcome is major bleeding.~      Sample size~      A total of 65 to 87 recurrent VTE events are needed to show a 50% reduction with LMWH as~     compared to VKA (type I error 0.05, two-sided, power respectively 80 and 90%). To observe 75~     events, with a 10% event rate per half year in the VKA arm and 5% in the LMWH arm a total of~     1000 patients will need to be included.~      Organisation~      Outcomes will be adjudicated by a central adjudication committee. A steering committee will~     be formed, preferably consisting of one member of every participating center. An electronic~     case report form will be used for data collection. Also, an electronic trial master file will~     be used.~   "
183416|NCT01164033|"~     This open-label, randomized, cross-over study will evaluate the effect of food on the~     pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The~     anticipated time on study treatment is 3 weeks.~   "
183417|NCT01164020|"~     Resistance training as well as creatine supplementation may be beneficial for cognitive~     function, such as memory and attention. Therefore, the investigators speculate that~     resistance training combined with creatine supplementation would promote additive benefits on~     cognitive function in elderly women.~   "
183418|NCT01164007|"~     This study will assess the preliminary anti-tumor activity and safety profile of a~     combination of bevacizumab and dacarbazine in participants with unresectable/metastatic~     melanoma not previously treated with chemotherapy for metastatic disease.~   "
183419|NCT01163994|"~     The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus~     15-day doxycycline treatment in patients with multiple erythema migrans.~   "
183420|NCT01163981|"~     The investigators suspect that using ultrasound to guide insertion of needles for dialysis~     patients will make this process quicker and more accurate, thus reducing complications and~     reducing discomfort for patients.~   "
183421|NCT01163968|"~     The purpose of this study is to examine the use of a home-based program to improve weight~     reduction after percutaneous coronary intervention (PCI) (either a cardiac stent or~     angioplasty procedure).~   "
183422|NCT01163955|"~     To determine if sitting in a chair or sitting on the floor lends itself to better posture~     while playing video games.~   "
183423|NCT01163942|"~     The purpose of this study is to examine the effect of G-CSF on disease free survival and~     overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.~   "
183424|NCT01163929|"~     The primary objective of this study is to assess whether a combination of chemotherapy,~     Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of~     surgery in 50% of enrolled patients.~   "
183425|NCT01163916|"~     The primary objective of this post-marketing observational study was to obtain data on the~     characteristics (patient age/gender; disease type, severity and duration; disease specific~     treatment history; current concomitant medications; other relevant medical history) of~     patients prescribed adalimumab (Humira®) for rheumatoid arthritis (RA), ankylosing~     spondylitis (AS) and psoriatic arthritis (PsA) as part of routine clinical care in Russia.~   "
183426|NCT01163903|"~     This is a single-centre, open label, dose finding, phase I study to determine the recommended~     phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in patients with~     advanced tumours and no standard treatment options. A minimum of 3 patients will be enrolled~     per dose level and intra-patient dose escalation is not permitted. Once the RP2D has been~     identified, six additional patients with metastatic solid tumours will be treated at the RP2D~     to confirm its tolerability.~   "
183429|NCT01163864|"~     Recent data indicate that approximately one-third of women of childbearing age smoke~     cigarettes, and 25-50% of women smoke during pregnancy. Cigarette smoking during pregnancy is~     a significant public health issue that can have profound effects on women's health and the~     health of their developing fetus. Smoking among pregnant women is associated with high levels~     of negative affect, which play a key role in the maintenance of smoking behavior and in~     difficulty quitting smoking during pregnancy. Despite the clear role of negative affect in~     the maintenance of smoking among pregnant women, and while this issue has received increased~     attention by clinicians and researchers, the investigators know of no smoking cessation~     intervention that combines coping skills and emotion regulation approaches to address the~     role of negative affect in smoking cessation. Smoking cessation treatment strategies that~     have demonstrated effectiveness in regular smokers have not translated into effective~     treatment strategies for pregnant women, particularly low-income pregnant women. The goal of~     this project is to develop and test an affect regulation smoking cessation intervention for~     low-income pregnant smokers.~      The major aims of this project will be addressed in two sequential phases. In Phase 1, the~     investigators will develop two 8-session smoking cessation treatment manuals including: (a)~     Affect Regulation Training plus Cognitive-Behavioral Treatment (ART+CBT) and (b) a Health and~     Lifestyle plus Cognitive-Behavioral Treatment (HLS+CBT) control intervention. In Phase 2, the~     investigators will conduct a randomized clinical trial pilot study (Total N = 60) to compare~     the ART+CBT and HLS+CBT conditions on: a) the feasibility and acceptability of the~     interventions, (b) the impact of these interventions (ART+CBT and HLS+CBT) on smoking~     cessation rates at the end of the 8 treatment sessions (these occur approximately 2 months~     after treatment initiation) and at the 6-month post-quit date assessment (Session 2 is the~     quit date), (c) affect regulation skills, and (d) negative affect among pregnant smokers. The~     long-term goal of this proposed research is to increase smoking cessation rates among~     pregnant smokers, which would provide significant long-term health benefits for both mothers~     and their infants. This Stage 1 application will be used to generate feasibility and~     preliminary efficacy data, setting the stage for a Stage II efficacy trial.~   "
183430|NCT01163851|"~     The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics~     of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin.~     PF-04950615 (RN316) is an investigational drug that is currently being studies as a~     cholesterol lowering therapy.~   "
183431|NCT01163838|"~     The primary objective of this study is to evaluate the safety and tolerability of repeated~     doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is~     currently being studied as a cholesterol lowering therapy.~   "
183432|NCT01163825|"~     Cholinergic neurons in the basal forebrain project widely to the cerebral cortex and~     hippocampus. These neurons depend on nerve growth factor (NGF) from their target areas for~     survival. Impaired NGF supply is part of the Alzheimer's disease (AD) pathology, and the~     degeneration of these neurons correlates with the cognitive decline in these patients. The~     objective of encapsulated cell biodelivery (ECB) is to maintain normal levels of NGF to~     support cholinergic function. NsGene's NGF secreting ECB device (NsG0202) combines the~     potential benefits of targeted gene therapy with the safety of a retrievable implantable~     device.~      The study is an open label, single centre, 12-month, dose-escalation phase Ib study in~     patients with mild to moderate AD. The primary objective is safety and tolerability, while~     secondary outcomes measure include cognition, behaviour, neuropsychology, activities of daily~     living (ADL), positron emission tomography (PET) imaging and electroencephalography (EEG).~   "
183433|NCT01163812|"~     Objectives of this study was to determine whether laparoscopy-assisted distal gastrectomy~     (LADG) with complete D2 lymph node dissection for gastric cancer is a safe and effective~     surgical option.~      Methods: total 64 patients, who are diagnosed preoperatively as having T1-2, N0-1 or M0~     gastric cancer, will be prospectively enrolled to undergo LADG with D2 lymph node dissection;~     two surgeons with experience of over 50 cases of laparoscopic gastrectomy performed the~     procedures. The compliance rate, defined as cases with no more than one missing lymph node~     station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node~     grouping, for the open gastrectomy with D2 lymph node dissection was 66.0% in a pilot study~     and was used for calculations of sample size. Compliance rate and other surgical outcomes,~     including the number of retrieved lymph nodes from each lymph node station, morbidities,~     mortalities and conversion rate will be analyzed.~   "
183434|NCT01163799|"~     The purpose of this study is to assess Alefacept in combination with alemtuzumab induction~     and calcineurin inhibitor and corticosteroid withdrawal.~   "
183435|NCT01163786|"~     Approximately 10,000 allogeneic hematopoietic stem cell transplants (HSCT) are performed~     annually in the US for various indications. Bronchiolitis obliterans (BO) is the most common~     late noninfectious complication following allogeneic hematopoietic stem cell transplant.~     Prognosis of BO in the allogeneic HSCT setting is dismal and there are no therapies proven to~     be consistently effective. The exact incidence is not clear but may be as high as 30%2 . Risk~     factors include new or ongoing chronic graft versus host disease (cGVHD), age, antecedent~     obstructive airways disease and viral infections1. BO is characterized physiologically by~     progressive irreversible airflow obstruction and pathologically by luminal occlusion of the~     distal airways due to progressive scarring3. The pathogenesis is not completely understood~     but the cytokine transforming growth factor-beta 1 (TGF-b1), important for both tissue repair~     and fibrosis, is thought to play a pivotal role. Bortezomib, an FDA approved proteasomal~     inhibitor inhibits TGF-b1 signaling in vitro and protects against lung injury/fibrosis in~     bleomycin mouse model as well as in a mouse model for skin fibrosis. This is consistent with~     other data in the literature that proteasomal inhibition can prevent the development of~     fibrosis. Thus the investigators propose to test the safety, tolerability and efficacy of~     bortezomib in chronic pulmonary GVHD (BO).~   "
183436|NCT01163773|"~     Cardiovascular disease (CVD) represents the first cause of mortality in industrialized~     countries such as Canada and the United States. In that regard, it is being increasingly~     recognized that a significant proportion of CVD events may be attributable to the presence of~     a cluster of metabolic and physiological perturbations defined as the metabolic syndrome~     (MetS). The National Cholesterol Education Program- Adult Treatment Panel III (NCEP-ATP III)~     has recently proposed a clinical definition to identify individuals with the MetS. This~     definition is based on the presence of at least three of the following five characteristics:~     1- abdominal obesity, 2- hypertriglyceridemia, 3- reduced plasma HDL-C levels, 4- high blood~     pressure, 5- high fasting blood glucose levels. Recent data have suggested that the MetS~     based on this definition was associated with a 2 to 5 fold increase in the risk of CVD in men~     as well as in women. These are alarming figures since it has been suggested that as much as~     35 to 45% of female aged > 65 years in the US may have the MetS. It is therefore imperative~     to develop new preventive strategies that will be efficacious in attenuating the impact of~     the MetS on the progressing rates of CVD in women. In that context, there is accumulating~     evidence to suggest that milk and dairy products may beneficially modify several components~     of the MetS. However, most of the available data to date are based on observational studies~     or interventional studies with minimal nutritional control. Thus, metabolically controlled~     studies that document the impact of milk consumption on cardiovascular risk factors~     associated with the MetS in women defined a priori as having the MetS are utterly lacking.~      The purpose of this study was to investigate the impact of milk consumption on features of~     the MetS in menopausal women presenting one or more features of the MetS.~   "
183437|NCT01163760|"~     This study seeks to evaluate the clinical performance of two daily disposable contact lenses.~   "
183946|NCT01157065|"~     The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as~     measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a~     single intravitreal injection, as compared to LUCENTIS.~   "
183440|NCT01163721|"~     This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM)~     despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have~     benefited from additional control of blood glucose levels. The study assessed the metabolic~     effects of ranolazine, including its effect in lowering glycosylated hemoglobin A1c (HbA1c),~     and lowering glucose while fasting, and following a meal (postprandial).~      Participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were~     stratified by HbA1c ≤ 7.5% or > 7.5%. Enrollment was to include no more than two-thirds of~     participants with baseline HbA1c ≤ 7.5%. Other than glucose values, efficacy endpoint results~     remained blinded during the study; for safety purposes, the investigator was to be alerted of~     severe hyperglycemia or hypoglycemia.~      Participants were instructed to maintain logs of their physical activity/exercise (Subject~     Activity Assessment) and study drug dosing (Dosing Log).~   "
183441|NCT01163708|"~     This project aims to assess two different techniques used to position the knee replacement~     implant during surgery. The patients will be randomised to receive either the following:~        1. The established Navigation System (gold standard)~        2. The new Prophecy Technique (validated by the Navigation System)~      The study hypothesis is there will be no difference between the gold standard Navigation~     system and the Prophecy technique in relation to the placement of the knee implant.~   "
183442|NCT01163695|"~     This study examines an economic empowerment model of care and support for orphaned~     adolescents in rural Uganda. The Suubi intervention focuses on economic empowerment of~     families caring for orphaned youths. It attempts to address the health risks and poor~     educational achievements resulting from poverty and limited options.~   "
183443|NCT01163682|"~     This is a two arm randomized pilot study. This study seeks to determine if 12 weeks of weekly~     electroacupuncture will prevent or decrease neuropathic pain in breast cancer patients~     receiving 12 weekly treatments of taxane treatment.~   "
183444|NCT01163669|"~     The purpose of this study is to see if Hyperparathyroidism (HPT) is common in people who~     receive a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH)~     levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone~     disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor~     formation of red blood cells. Other problems from HPT may include increases in blood levels~     of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high~     calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause~     arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft~     tissue), heart and lung problems, or kidney transplant dysfunction (worsening of kidney~     transplant function). The purpose of this research study is to better understand the~     evolution of Hpt in people during the first 12 months after receiving a kidney transplant.~   "
183445|NCT01163656|"~     The investigators seek to prospectively compare intubation with the Glidescope Cobalt to~     Direct Laryngoscopy (DL) in infants.~   "
183446|NCT01163643|"~     The objective of this study is to identify the concentration and daily dosing frequency of~     BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.~   "
183447|NCT01163630|"~     The purpose of the study is to investigate the effects of food, in comparison to fasting~     conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and~     esomeprazole.~   "
183448|NCT01163617|"~     This was an open-label, Phase 2 study designed to obtain user experience data (Phase A) and~     injection time data (Phase B) in experienced adalimumab patients injected with the Physiolis~     pre-filled syringe and autoinjector used to administer adalimumab.~   "
183449|NCT01163604|"~     Argatroban is a selective thrombin inhibitor, and previous study had suggested that~     argatroban use post PCI could potentially prevent reocclusion. But there has no study on~     large sample of argatroban treated restenosis post cranial stenting. This study will test the~     safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with~     intracranial and extracranial artery stenting.~   "
183450|NCT01163591|"~     Diabetes mellitus (DM) is a metabolic disorder commonly encountered by the healthcare~     professionals. Diabetic nephropathy is one of its complications, which is becoming the most~     common cause of end-stage renal failure in Hong Kong. As of March 31, 2000, a total of 1026~     patients with diabetes were on renal replacement therapy and the number is steadily~     increasing. According to ADA guidelines, screening for diabetic nephropathy should be~     performed on an annual basis to assess urine albumin excretion rate. Serum creatinine should~     also be measured in all diabetic patients regardless of the degree of urine albumin excretion~     rate. Timed urinary collection can be a cumbersome procedure for patients and a simpler and~     fast test that maintains reasonable sensitivity is called for. A tool that is non-invasive~     and able to identify patients with early nephropathy changes would be valuable.~      The skin has been found to have the potential to provide an important non-invasive route for~     diagnostic monitoring of human subjects for a wide range of applications. eZscan® technology~     is a patented active electrophysiological technology which uses low level DC-inducing reverse~     iontophoresis, together with chronoamperometry, to evaluate the behaviour of the tissues in~     specific locations of the body. This non invasive test is a potential tool for the screening~     for diabetic nephropathy.~      The aim of this study is to compare eZscan with the standard methods of screening for~     diabetic nephropathy in patients with type 2 diabetes mellitus.~   "
183451|NCT01163578|"~     The objective of this study is to evaluate whether certain proteins, expressed in biological~     tissues can indict a better understanding of the effect of drugs that are used to treat~     rejection, and of processes leading to rejection and rejection-free outcomes.~   "
183462|NCT01163435|"~     Up to now, to our knowledge, there is few randomized, large scale study prospectively and~     simultaneously comparing the efficacy, adverse effects and patient adherence of these current~     recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our~     country.~      The aims of this study are:~        1. to compare the efficacy of high dose dual therapy, sequential therapy and~          clarithromycin-based triple therapy as 1st-line regimen in H. pylori eradication;~        2. to compare the efficacy of high dose dual therapy, sequential therapy and~          levofloxacin-based triple therapy as rescue regimen in H. pylori eradication;~        3. to compare the patient adherence and adverse effects of these treatment regimens;~        4. to investigate factors that may influence H. pylori eradication by these treatment~          regimens;~        5. to investigate and analyze the prevalence and trend of antibiotic resistance.~   "
183452|NCT01163565|"~     This is a randomized, prospective equivalence trial on the safety of the Ligasure Vessel~     Sealing System as used in thyroid surgery. The Ligasure system is a hand held surgical device~     that uses heat to seal blood vessels during surgery. It has been a tested and accepted~     technology in abdominal surgery and it is now being applied to surgery of the thyroid gland~     because it is faster than the traditional method of tying blood vessels that a surgeon must~     do manually. To remove the thyroid gland safely the surgeon must dissect the gland away from~     the recurrent laryngeal nerve which controls the vocal cords and patient's voice. Protecting~     this nerve is the key step in all thyroid surgery as its damage can permanently alter a~     patient's voice and even obstruct the airway. At this time the worldwide accepted rate of~     nerve injury is 2 in 100 patients. The hypothesis of this study is that the nerve injury~     rates for surgery using the Ligasure device are similar to that seen when surgeons manually~     tie blood vessels. The investigators protocol will evaluate the function of the recurrent~     laryngeal nerve after removing the thyroid gland using the Ligasure device in comparison to~     the traditional method where the surgeon manually ties blood vessels. In this study, for~     patients undergoing total thyroidectomy for a benign condition, each patient will be~     randomized to have one lobe of thyroid (left or right) removed using manual tying of blood~     vessels and the other side will have the surgeon use the Ligasure device to seal blood~     vessels. Every patient has a pre− and post−operative independent assessment of vocal cord~     function using nasopharyngoscopy to ensure that the vocal cords are working normally prior to~     surgery and also to document vocal cord dysfunction if there is an injury to the recurrent~     laryngeal nerve. The investigators intent is to show that the Ligasure system is a safe~     method to sealing vessels in thyroid surgery and that the thermal dispersion of this device~     does not pose a significant increase in risk to the recurrent laryngeal nerve~   "
183453|NCT01163552|"~     Cancers that have spread to the inner lining of the chest are classified as Stage IV and bear~     a poor prognosis. Surgery is rarely an option, with palliative chemotherapy and/or radiation~     therapy the only treatment options. This study intends to evaluate whether surgical removal~     of all visible tumor on the chest wall followed by bathing the chest cavity in heated~     chemotherapy solution will improve outcomes for these advanced cancers.~   "
183454|NCT01163539|"~     The purpose of this study is to look at pain control and QOL improvement after treatment with~     CK Radiosurgery for spinal metastases.~   "
183455|NCT01163526|"~     A research study of liver perfusion (how blood flows to the liver over time). We hope to~     learn whether perfusion characteristics of liver masses may be predictive of response to~     treatment and whether liver perfusion characteristics can be used to follow response to~     treatment.~   "
183456|NCT01163513|"~     The purpose of this study is to determine the extent to which South Asian ethnicity is both~     an etiologic and prognostic factor for coronary disease, and investigate factors influencing~     outcomes.~   "
183457|NCT01163500|"~     Coenzyme Q10 (Ubiquinone) is recognized as an endogenous fat-soluble antioxidant in the~     mitochondrial membrane and considered as a preventive factor for coronary artery disease~     (CAD). However, the relationships between coenzyme Q10 and the prevention of the risk of CAD~     are still inconsistent. The purposes of this study are to investigate the relation of~     coenzyme Q10 concentration with the blood lipid levels, plasma homocysteine, the markers of~     lipid peroxidation (TBARS, ox-LDL),antioxidant enzymes activities (catalase, glutathione~     peroxidase, superoxide dismutase)and to examine the association with the risk of CAD.The CAD~     patients is identified by cardiac catheterization as having at least 50% stenosis of one~     major coronary artery (n = 100). The second year is a double-blind, placebo-controlled~     intervention study. CAD subjects (n = 60) are randomly assign to one of the three groups~     (coenzyme Q10 supplements 60 mg/d, 150 mg/d, and placebo groups, n = 20/group). Intervention~     is going to administration for three months. The third year is a case-control study. The~     control group （n = 100） is comprised of healthy individuals with normal blood biochemical~     values, and match by age and gender with the first year CAD subjects (case group). Fasting~     blood samples will be obtain to determine the concentration of coenzyme Q10, homocysteine,~     the markers of lipid peroxidation,antioxidant enzymes activities. The differences between~     case and control groups will be compared by using Student's t-test. Conditional logistical~     regression model will be performed to calculate the odds ratio for CAD based on coenzyme Q10~     level. Hopefully, the results of this study could provide the information to what has been~     know in CAD subjects. We expect coenzyme Q10 could be a preventive supplement to reduce the~     risk of CAD.~   "
183458|NCT01163487|"~     The purpose of this study is to study the effect of the drug DCA (dichloroacetate) on~     recurrent head and neck cancers. Part of this study will also use EF5 PET scan to study tumor~     hypoxia.~   "
183459|NCT01163474|"~     Telemedicine has been widely used in managing patients with neurologic disorders or mental~     illness. Telemedicine is defined as the use of medical information exchanged from one site to~     another via electronic communications for the health and education of the patient or~     healthcare provider and for the purpose of improving patient care. According to our~     knowledge, it has not been used to manage cardiac patients who need postoperative care after~     discharge from hospitals.~      The use of telemedicine has the potential to reduce the cost of unnecessary travel by~     assessing the patient's postoperative status prior to making decisions as to whether or not a~     face-to-face consultation is necessary.~      In this pilot study we will compare the accuracy of surgeons' decisions during follow-up~     visits via video-teleconference (V-Visit) to surgeons' decisions during traditional~     face-to-face follow-up visits (FTF-Visits). Both the V-Visit and the FTF-Visit will take~     place at the Houston Michael E DeBakey VA Medical Center on the same day. We will also ask~     both patients and providers to complete short questionnaires after each V-Visit regarding~     their acceptability of using telemedicine for these post-operative follow-up visits.~      Information collected as part of this pilot study will be used to design a future full~     randomized controlled trial (RCT) on the use of telemedicine in evaluating post-operative~     cardiac surgical patients.~   "
183460|NCT01163461|"~     This is a behavioral speech therapy trial for individuals who have suffered a stroke on the~     left side of the brain and have difficulty speaking. The name of this disorder is called~     'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for~     free (2 hours/day, 5 days/week, 6 weeks).~   "
183461|NCT01163448|"~     This study is being done to test the safety of a single high-dose of radiation therapy before~     radical prostatectomy (removal of the prostate). The investigators want to find out what~     effects, good and/or bad, the radiation will have on men undergoing prostatectomy. The~     investigators are especially interested in men who are at risk for having cancer cells that~     have spread outside the prostate.~   "
183463|NCT01163422|"~     The purpose of this study is to determine whether cardiac resynchronization therapy with the~     use of an implanted electronic pacemaker reduces morbidity associated with chronic~     thromboembolic pulmonary hypertension~   "
183593|NCT01161732|"~     The optimal timing of surgical intervention remains controversial in asymptomatic patients~     with very severe aortic stenosis. The investigators therefore try to compare long-term~     clinical outcomes of early surgery with those of conventional treatment strategy in a~     prospective randomized trial.~   "
183464|NCT01163409|"~     Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in~     pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised~     aerobic exercise, as well as treatment versus combination with aerobic exercise and~     resistance exercise the major muscle groups, both supervised versus group control, who just~     get guidance for physical activity.~   "
183465|NCT01163396|"~     This is a single-arm, open-label, multicentre phase II study evaluating the safety and~     efficacy of the combination of the G.O.N.O. FOLFOXIRI regimen with bevacizumab as first-line~     treatment of metastatic colorectal cancer.~   "
183466|NCT01163383|"~     Metaiodobenzylguanidine (MIBG) is a substance that is taken up by neuroblastoma or~     pheochromocytoma/paraganglioma tumor cells. MIBG is combined with radioactive iodine (131 I)~     in the laboratory to form a radioactive compound 131 I-MIBG. This radioactive compound~     delivers radiation specifically to the cancer cells and causes them to die.~      The purpose of this research protocol is to provides a mechanism to deliver MIBG therapy when~     clinically indicated, but also to provide a mechanism to continue to collect efficacy and~     toxicity data that will be provided.~   "
183467|NCT01163370|"~     Resistance training as well as creatine supplementation may increase bone mass. Therefore,~     the investigators speculate that resistance training combined with creatine supplementation~     would promote additive benefits on bone mass in elderly women with osteopenia and~     osteoporosis.~   "
183468|NCT01163357|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving chemotherapy drugs, such as fludarabine phosphate and~     melphalan, and total marrow irradiation before a donor peripheral blood stem cell transplant~     helps stop the growth of cancer cells and helps stop the patient's immune system from~     rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into~     the patient they may help the patient's bone marrow make stem cells, red blood cells, white~     blood cells, and platelets.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with fludarabine phosphate and melphalan with or without total marrow~     irradiation in treating patients undergoing donor peripheral blood stem cell transplant for~     high-risk stage I or II multiple myeloma.~   "
183469|NCT01163344|"~     The purpose of this study is to gather data to see if so-called enriched forms of exercise~     programs such as dance is more effective in improving balance and quality of life in patients~     with idiopathic Parkinson's disease than regular exercise programs that are currently~     provided by physical therapists.~   "
183470|NCT01163331|"~     This study will compare group singing to group speech therapy without singing. You may be~     eligible for this study if you have been diagnosed with PD for one year or more and you have~     a quiet voice or difficulty being understood.~   "
183471|NCT01163318|"~     The purpose of this study was to collect data on the incidence of adverse drug reactions,~     infections and malignant tumors, as well as factors that might affect the safety and~     effectiveness of Humira® (adalimumab; 40mg/0.8 mL) in Japanese participants who received the~     drug for the treatment of rheumatoid arthritis.~   "
183472|NCT01163305|"~     The purpose of this study is to identify an early indicator of drug efficacy in patients with~     advanced colorectal cancer - a prospective evaluation of circulating tumor cells,~     positron-emission tomography scan and RECIST criteria.~   "
183473|NCT01163292|"~     The present survey was conducted to evaluate the effectiveness and safety of treatment with~     adalimumab during the 52-week period following completion of the treatment period in Study~     NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.~   "
183474|NCT01163279|"~     Healthy older adults with self-reported cognitive difficulties who receive strategy training~     will demonstrate greater performance benefits on measures of real-world activities, relative~     to those receiving a control intervention, immediately post treatment and at follow-up.~   "
183475|NCT01163266|"~     The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD),~     compared with placebo in adults with major depressive disorder.~   "
183476|NCT01163253|"~     The main objective of this study is to evaluate the long-term safety of CP-690,550 in~     patients being treated for moderate to severe chronic plaque psoriasis. This is an open label~     extension study available to patients who participated in one of the qualifying studies with~     CP-690,550 providing entry criteria is met.~   "
183477|NCT01163240|"~     The purpose of this study is to collect epidemiological data in children and adolescents with~     chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with~     associated ALT levels , active HBeAg negative disease and decompensated CHB in the pediatric~     population. Family history and history of HBV transmission is essential to assess the course~     of the disease and can be used to determine the best mode of treatment This information will~     be used to assist with the feasibility and design of studies for the Novartis clinical~     pediatric development program, as the current epidemiology of ediatric CHB is not accurately~     known in Western countries or the rest of the world making pediatric studies difficult to~     plan and conduct. This study forms part of the Novartis Pediatric Investigational Plan, a~     post marketing approval commitment to the EMEA Pediatric Committee.~   "
183478|NCT01163227|"~     This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients~     with chronic stable schizophrenia.~   "
183479|NCT01163214|"~     The purpose of this study is to compare two methods of postoperative pain management in~     patients undergoing total knee replacement.~   "
183480|NCT01163201|"~     This is a unique dose-escalation trial that will titrate doses of umbilical cord blood (UCB)~     Treg and CD3+ Teff cells with the goal of infusing as many CD3+ Teff cells as possible~     without conferring grade II-IV acute graft-versus-host disease (GVHD).~      In this study, the investigators propose to add UCB Treg and UCB CD3+ Teff cells to the two~     TCD UCB donor units with the goal of transplanting as many CD3+ Teff cells as possible~     without reintroducing risk of acute GVHD. The investigators hypothesize that Treg will permit~     the reintroduction of CD3+ Teff cells that will provide a bridge while awaiting HSC T cell~     recovery long term. The co-infusion of Treg will prevent GVHD without the need for prolonged~     pharmacologic immunosuppression.~   "
183505|NCT01162876|"~     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of~     saxagliptin administered before breakfast for 14 consecutive days in patients with type 2~     diabetes mellitus.~   "
183481|NCT01163188|"~     The major aim is the follow-up of the highest risk group (< 32 weeks gestation/ < 1500~     birthweight) and their controls of the Bavarian Longitudinal Study (BLS) at the age of 24-27~     years. The focus will be the identification of risk, protective and resiliency factors for~     cognitive and behavioural development and quality of life.~      MRIs of the central nervous system will be conducted to examine aberrant activation patterns~     during the attention network task in stratified subgroups. Data driven MRI methods will be~     evaluated in relation to clinical, behavioural and developmental parameters.~   "
183482|NCT01163175|"~     The majority of trans fatty acids consumed by the general population is derived from products~     that have been formulated using significant amount of hydrogenated vegetable oil (the~     so-called industrial trans fat). Fat from ruminants also contains small amounts of trans~     fatty acid, which contribute, although to a smaller extent, to the total dietary intake of~     trans fatty acids in the general population. The negative impact of consuming industrial~     trans fat on health, particularly on cardiovascular disease, is being increasingly~     recognized. Based on data available to date, it is currently not possible to conclude if~     effects of ruminants and industrial trans fatty acid on cardiovascular risk are different.~     There is therefore an urgent need for a study that compares the impact of naturally occurring~     trans fatty acids such as those from dairy products and of trans fatty acids form industrial~     sources on cardiovascular risk factors as well as their mechanisms of action.~      The general objective of the study is to investigate the impact of naturally occurring trans~     fatty acids from dairy products (mainly vaccenic acid) on plasma cholesterol levels and other~     risk factors for cardiovascular disease.~   "
183483|NCT01163162|"~     The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney~     functioning. The investigators hypothesize that the increase in serum creatinine observed in~     recent paricalcitol trials is a function of reduced creatinine secretion and not an actual~     reduction in kidney function. 16 patients will have kidney function measured via iothalamate~     clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being~     washed off the paricalcitol.~   "
183484|NCT01163149|"~     This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by~     gene mutations or changes. These gene mutations cause low levels of an enzyme needed to~     harden bone. The purpose of this study was to test the safety and efficacy of two doses of~     the study drug called asfotase alfa as compared to a control group to see effects on~     adolescents and adults with HPP.~   "
183485|NCT01163136|"~     This study will look at a cohort of parents whose children are confronting life-threatening~     illnesses in intensive care, palliative care, and complex care settings, to test whether~     parents with higher levels of hopeful patterns of thinking are subsequently more likely a) to~     change the level of care order status of their child (as an important and demonstrable~     example of adapting goals); b) to reprioritize goals for the child when they are reassessed~     regarding goals ; and c) to report a higher degree of achieving self-defined 'good parent'~     attributes.~   "
183486|NCT01163123|"~     Japanese encephalitis (JE) is one of important zoonotic infectious diseases in Taiwan. JE~     caused by Japanese encephalitis virus (JEV) which transmitted by Culex tritaeniorhynchus and~     used swine as amplifying host. Infections leading to overt encephalitis are estimated to be 1~     in 1000 cases. Among JE confirmed cases, approximately 25 percent of cases die and 50 percent~     of the survivals develop permanent neurologic and/or psychiatric sequelae. JEV circulated in~     Taiwan are belonged to genotype III and the vaccine strain selected from same genotype.~     Genotype I JEV was first detected in northern Taiwan in 2008 by CDC, and the same genotype~     JEV were detected in mosquito collected in central Taiwan by our group. In order to study the~     genotypic shift of JEV in Taiwan areas, and the effects of the replacement of genotype on~     vaccine, we will conduct the JEV seroepidemiology in Hualien county which was the highest~     incidence of JEV in Taiwan. The aims of this study were: (1) study the circulating of~     genotype I JEV in Hualien county; (2) determine the virulence of genotype I JEV in human; (3)~     differential diagnosis of JEV genotype I or III infection among confirmed cases; (4) measure~     the cross neutralizing activity, after immunized with genotype III JEV vaccine, against~     genotype I JEV; (5) determine the age-specific seroprevalence of JEV antibody; (6) estimate~     the annual risk of infection for JEV.~   "
183487|NCT01163110|"~     The purpose of this study is to measure the therapeutic potential of Escherichia coli (E.~     coli) and yeast ribosomal Ribonucleic acid (RNA) fragments to maintain the production of~     platelets in patients undergoing cytotoxic therapy for cancer.~   "
183488|NCT01163097|"~     The purpose of this study is to evaluate the effect of a continuous intravenous infusion of~     unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult~     subjects.~   "
183489|NCT01163084|"~     This randomized phase I/II trial studies giving leuprolide acetate or goserelin acetate~     together with or without vismodegib followed by surgery to see how well they work in treating~     patients with prostate cancer that has spread from where it started to nearby tissue or lymph~     nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as~     leuprolide acetate or goserelin acetate, may lessen the amount of androgens made by the body.~     Vismodegib may slow the growth of tumor cells. Giving antihormone therapy together with~     vismodegib may be an effective treatment for prostate cancer.~   "
183490|NCT01163071|"~     The purpose of this study is to determine the MTD and/or RP2D of ABI-011 when administered by~     IV on Day 1, Day 8 and Day 15 with one week of rest for patients with advanced solid tumor~     malignancies and lymphomas.~   "
183491|NCT01163058|"~     Aim of the present retrospective study is to evaluate molecular factors of primary resistance~     to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The~     investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and~     Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor~     (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and,~     secondly, the investigators correlate molecular markers with clinical features and outcome in~     terms of response rate, progression free survival and overall survival.~   "
183492|NCT01163045|"~     The purpose of this study is to evaluate if intraoperative neuromonitoring associated to~     neurostimulation of recurrent laryngeal nerve reduce the rate of recurrent laryngeal palsy~     respect to neurostimulation alone.~   "
183493|NCT01163032|"~     The purpose of this study is to evaluate the efficacy and safety of a six month double-mask~     treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake~     Disorder~   "
183494|NCT01163019|"~     Background: Chest pain (CP) and suspected heart attack is the second most frequent complaint~     among patients presenting to the emergency department (ED). Present workup involves~     in-hospital observation for 6 - 48 hours and requires significant resources including imaging~     tests, some of which are invasive and involve radiation and radio-contrast agents, which can~     be toxic to the kidney.~      CP can result from impaired blood supply to the heart muscle, which may result in impaired~     contraction of the heart that persists for several days. Bedside echocardiography with~     semi-automated speckle tracking strain analysis (2D strain) is a novel promising noninvasive~     tool for the evaluation of heart muscle contraction. 2D strain can be useful for evaluating~     patients with CP, since it can accurately detect minor impairment in heart muscle contraction~     that can identify patients with coronary artery disease (CAD) and impending heart attack~     (coronary arteries are the arteries supplying blood to the heart muscle).~      Working hypothesis and aims: The investigators hypothesize that a bedside echo study with~     normal 2D strain may allow quick and safe ruling out of a heart attack and significant CAD~     disease as the cause of CP.~      The main aim of the study is to validate the investigators preliminary findings in a large~     number of patients in order to establish whether a normal 2D strain can safely rule out a~     heart attack or life threatening CAD.~      Methods: In a large multi-center study 1200 patients presenting to the ED with acute CP of an~     unclear cause will undergo echocardiography as close as possible to presentation and not more~     than 24 hours from cessation of pain. Patients will undergo standard workup by the ED~     physicians. Standard echocardiographic findings, but not the 2D strain analysis, will be made~     available to the attending physician. Data from discharge letters, ECGs, blood tests, stress~     tests, nuclear imaging, heart CT and heart catheterization will be collected. A 6-month~     follow-up telephone interview will be performed to collect data on survival, heart attacks,~     re-hospitalization and revascularization (opening heart vessels blockages). 2D strain~     analysis will be performed off-line in a central laboratory to evaluate the ability of 2D~     strain to distinguish between patients with CP from heart disease and patients without life~     threatening heart disease that can be early released home safely.~      Expected results: The investigators expect, based on the investigators previous experience,~     that patients with normal 2D strain will have a very low probability of a heart attack and~     significant CAD. The investigators further expect these patients to have an excellent 6-month~     prognosis. This will allow their early and cost-effective discharge.~      Importance and Probable implications to Medicine: Reduction in ED patient load and a decrease~     in unnecessary hospitalizations for CP. Cost and resource savings and elimination of~     unnecessary imaging studies, some of which are invasive or involve radiation and contrast~     agents.~   "
183495|NCT01163006|"~     Controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by~     using soluble dietary fibres) may reduce the glycemic or insulinemic response. This may in~     turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma~     triacylglycerol concentration A higher postprandial fat oxidation may result in less lipid~     accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic~     profile in the longer term.~   "
183496|NCT01162993|"~     Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitus~     (DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering~     form DM. The burden of disease of painful diabetic polyneuropathy (PDP) is high for both the~     patient and society, due to significant pain levels, frequent co-morbidity, polypharmacy and~     significant health resource use. Spinal cord stimulation (SCS) has been used for over 30~     years to treat neuropathic pain. Several small clinical studies have shown a beneficial~     effect of SCS on pain in PDP.~      Objective: The primary objective of this study is to investigate whether SCS leads to~     clinically relevant (≥50%) pain relief in patients with moderate-to-severe PDP in the lower~     limbs after 6 months of treatment.~      Secondary objectives to investigate 1) the effect of SCS on health related quality of life in~     PDP; 2) the effect of SCS on the quality of sleep in PDP; 3) the effect of SCS on mood in~     PDP; 4) the effect of SCS on blood glucose control in PDP; 5) the effect of SCS on large and~     small nerve fibre functions in PDP; 6) identifying predictive factors for success of SCS~     treatment of PDP; after 6 months 7) the effect of SCS on small fibre loss and regeneration in~     PDP; and 8) costs, cost-utility and cost-effectiveness after 12 months of treatment.~      Study design: the study is a multi centre randomized controlled trial. Study population:~     Patients suffering from moderate-to-severe PDP in the lower limbs due to diabetes mellitus~     type 1 or type 2 as diagnosed by clinical symptoms (glove and stocking distribution).~      Intervention: patients assigned to group 1 will receive spinal cord stimulation (SCS) and/or~     best (drug) treatment as possible, patients assigned to group 2 will receive best (drug)~     treatment as possible.~      Main study parameters/endpoints: The main study parameter will be the mean pain intensity~     and/or maximal pain intensity during daytime and/or during night time as measured on a~     weighted NRS and/or a PGIC for pain and sleep measured on a 7-point Likert scale, after 6~     months of treatment.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: SCS related risks include: lead migration (14%), lead breakage (7%), implanted~     pulse generator migration (1%), loss of therapeutic effect, lost or unpleasant paresthesias~     (12%), infection or wound breakdown (10%), Pain at IPG incision site (12%), IPG pocket fluid~     collection (5%). Treatment-as-usual related risks are related to the medication used and do~     not increase due to participation in this study.~   "
183497|NCT01162980|"~     ACE inhibitors have been studied extensively in the treatment of heart failure and have been~     shown to be beneficial in all its stages. Studies with the use of angiotensin receptor~     blockers (ARBs) in chronic heart failure have not shown equivalent results. Many patients are~     on an ARB for a variety of reasons. Some of these may have had cough as a symptom of heart~     failure and not due to medication side effect. According to guidelines, angiotensin~     converting enzyme inhibitors (ACEi) are still first-line therapy in the treatment of heart~     failure. As ACEi have been extensively studied showing improvement in morbidity and mortality~     all patients should be on this treatment unless absolutely contraindicated.~   "
183498|NCT01162967|"~     The investigators propose the evaluation of posaconazole and benznidazole in humans for the~     treatment of Chagas disease chronical infection. Exploratory trial of posaconazole~     antiparasitic activity against Trypanosoma cruzi.~   "
183499|NCT01162954|"~     This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial.~     The study is designed to evaluate the safety and local tolerability of DA-6034 upon single~     and repeated-dose topical application to the both eyes in healthy volunteers.~   "
183500|NCT01162941|"~     Proportion who would avoid splenectomy at 6 months of follow up~   "
183501|NCT01162928|"~     The primary objective is to assess the effect of fish oil-enriched enteral and parenteral~     nutrition on blood oxygenation in critically ill patients.~   "
183502|NCT01162915|"~     This study is based on preclinical (animal) studies showing that infusing bone marrow-derived~     mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function~     in animal models with spinal cord injuries. Bone marrow (BM) contains several types of stem~     cells that can produce functional cells. This includes cells that could help the healing~     process of damaged neurologic tissue.~      The primary objective of this study is to see if the injection of these cells, obtained from~     your own bone marrow, is safe. A secondary objective is to evaluate if the treatment can~     provide functional improvements (neuromuscular control and sensation) in the affected areas.~   "
183503|NCT01162902|"~     Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta~     blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery~     disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more~     important than relieving angina symptom. Dysfunction of microvessel is one of the most~     important factor in patients with coronary artery disease. Recently, we developed the new~     non-invasive method of evaluating the microvessel in fundus. With this methods, we will~     compare the effect of each drug (beta blocker, CCB, ARB).~   "
183504|NCT01162889|"~     This is a first in human study to determine the safety and tolerability of the drug after~     single doses. Nine doses of increasing strength will be injected or infused (given into a~     vein) to 9 different groups of people. One third of the participants will be given an~     injection or infusion of placebo (sugar water). All participants will be healthy people.~   "
183506|NCT01162863|"~     Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or~     discomfort in association with altered bowel habit. IBS is further subcategorized as three~     types according to the predominant bowel movement pattern: IBS with constipation (IBS-C), IBS~     with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain incompletely~     understood, but proposed mechanisms include abnormal motility, visceral hypersensitivity,~     abnormal brain-gut interactions, psychological distress, and altered GI tract motility.~      Lubiprostone, a novel drug that works by activating the colonic Chloride channel type~     2(ClC-2), has been approved for use in patients with chronic idiopathic constipation and~     recently approved for the treatment of IBS-C in women aged 18 and older. By activating the~     ClC-2 chloride channel in the colon, lubiprostone allows more fluid secretion into the~     intestinal lumen which leads to softer stool consistency. In phase III clinical trials,~     patients with IBS-C receiving lubiprostone have reported improvements in many symptoms such~     as abdominal pain and constipation. However, there is limited physiologic data to explain how~     exactly lubiprostone improves IBS-C symptoms.~      The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal pH,~     pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown to~     accurately measure whole gut as well as regional (i.e. stomach, small bowel, colon) transit~     time.~      The primary aim of this study is to determine the effects of lubiprostone on whole GI tract~     transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through~     evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone~     vs. placebo on these parameters, and secondarily to evaluate changes in these parameters with~     differing doses of lubiprostone.~      The investigators hypothesize that lubiprostone will increase whole GI and colonic transit~     compared to placebo in patient with IBS. the investigators do not expect a change in~     intraluminal pH with lubiprostone compared to placebo.~   "
183507|NCT01162850|"~     Primary Objective: To determine whether there is improvement in the melasma of participants~     taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium~     Leucotomos is well tolerated in study subjects with melasma.~      To determine whether treatment with Polypodium Leucotomos improves the health-related quality~     of life.~   "
183508|NCT01162837|"~     This study will determine if the use of the BEAM device reduces the signs and symptoms of~     mild-to-moderate acne.~   "
183509|NCT01162824|"~     The investigators are hoping to discover the cause of chest pain in patients with a normal~     coronary arteriogram. For patients with chest pain coronary angiography is the standard~     method by which the blood vessels of the heart can be visualized and any narrowing can be~     assessed. In some cases the investigators find totally normal coronary blood vessels or only~     minor disease. Such a finding is associated with an excellent long term prognosis. However,~     as a large proportion of patients with normal coronary arteries or mild coronary narrowings~     often continue to experience recurrent chest pains the investigators are interested in~     understanding the mechanisms responsible for this. The investigators hypothesise that in many~     cases, coronary artery spasms are responsible for the recurrent chest pains. These spasms~     usually respond to treatment with drugs known as vasodilators. The acetylcholine test~     (ACH-test) has been recommended by the European Society of Cardiology and the American~     College of Cardiology as a diagnostic test. This test can reveal whether the coronary blood~     vessels have a tendency to go into spasm. The investigators plan in this study to carry out~     the test in patients who have chest pains suggestive of coronary narrowings but are found to~     have normal or only mildly narrowed coronary arteries on angiography. A positive test~     -indicating a tendency for spasm- may help guiding therapy with vasodilators, which are often~     very effective to prevent coronary spasms. The investigators would also like to take blood~     samples during the test (before and after) from every patient to measure blood markers and~     see if there is a relation between these markers and the result of the ACH-test.~   "
183510|NCT01162811|"~     The purpose of this study is to test the efficacy of visualization and relaxation exercises~     together with a structured behavioural attention from nurses during ablation of atrial~     fibrillation.~      The study will test the following hypothesis which is also aim for intervention:~      Relaxation and visualization performed in patients during ablation of atrial fibrillation~     combined with structured attention behaviour from the nurse reduces the patient's experience~     of pain and anxiety - and secondary reduces the consumption of painkillers and the number of~     episodes of adverse outcome that requires extra attention from staff.~      The survey is conducted as a controlled trial with a control group and an intervention group.~   "
183511|NCT01162798|"~     The purpose of this study is to assess growth of preterm infants fed a test formula compared~     to a standard formula up to the first 4 months of corrected gestational age.~   "
183512|NCT01162785|"~     The goal of this part (Part 1) of this clinical research study is to learn about the safety~     of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients~     with bladder cancer that has come back. The goal of Part 2 of this study is to learn about~     the safety of giving 2 more doses of SCH 72105 directly into the bladder of Part 1~     participants who had no sign of bladder cancer after Week 12. The level of effectiveness of~     SCH 72105 will also be studied by measuring the interferon (IFN) levels in the urine.~   "
183513|NCT01162772|"~     Cardiovascular events are the most common cause for death in type 2 diabetes mellitus (T2DM)~     patients. Male diabetics have a 2 to 3 fold risk for cardiovascular disease (CVD) whereas~     female diabetes patients have a 3 to 7 fold risk for suffering from a CVD.~      Endothelial dysfunction (ED) plays a central role in the development of atherosclerotic~     lesions. Moreover, ED represents an important diagnostic and prognostic parameter to estimate~     the cardiovascular risk in an early state. Experimental and clinical studies indicate that~     T2DM is closely associated with ED, which may be the consequence of a reduced bioactivity of~     nitric oxide (NO).~      The success of diabetes therapy is monitored by the long-term parameter HbA1c. However, only~     two thirds of all patients with T2DM in the USA and Europe find themselves in the recommended~     HbA1c span (6.5-7.0 %). Consequently, oral anti-diabetic medication needs permanent~     adjustment and intensification in order to delaying the progress of T2DM.~      Recently, two peptide hormones with insulinotropic effects were identified. These hormones,~     glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are~     secreted by the gastrointestinal tract after exposure to glucose in nutrition. Physiological~     effects are increased insulin secretion, inhibition of glucagon secretion and reduction of~     body weight. Furthermore, these incretins are reduced in patients with impaired glucose~     tolerance. Thus, the therapeutic approach lies within the elevation of GLP-1 and GIP by~     preventing their degradation through the enzyme DPP-4 (dipeptidylpeptidase 4).~      Thereby, the so-called gliptins inhibit the DPP-4 enzymes. Best results in HbA1c reduction~     were achieved when gliptins were combined with metformin, glimepiride or pioglitazone.~      In this study, patients with T2DM, who are taking metformin as first line medication but do~     not achieve a HbA1c below 7.0 %, will routinely get an add-on therapy with gliptins~     (Vildagliptin or Sitagliptin) as second line therapy according to the guidelines of the~     Österreichische Diabetes Gesellschaft (ÖDG) prescribed by a medical doctor not involved in~     this study. This medication is a ÖDG standard therapy in T2DM, which patients receive anyway~     despite this study. Therefore, the therapy with gliptins is not a study medication and is not~     influenced by the study either. Only patients, who will meet the inclusion criteria of the~     study and voluntarily participate in the study, will be investigated.~   "
183535|NCT01162486|"~     The aim of this study is to evaluate (1) the safety and tolerability of escalating doses of~     rifapentine (RPT) administered daily by oral; (2) the effect of increasing doses of RPT on~     cytochrome P450 isoform 3A (CYP3A) enzyme metabolizing activity, using single-dose midazolam~     (MDZ); and (3) the effect of increasing doses of RPT on autoinduction of RPT metabolism.~   "
183514|NCT01162759|"~     The goal of this project is to improve hypertension control at Kaiser Permanente Colorado~     (KPCO) by implementing a population-based multi-factorial intervention that uses home BP~     monitors that can download BP readings to KPCO's health records via internet, interactive~     voice response (IVR) technology, and multidisciplinary care team. Participants will be~     randomized to either the home blood pressure monitoring group receiving the multi-factorial~     intervention or the usual care group who will be receiving Kaiser standard of care. We will~     determine the proportion of patients in each group who achieve their target BP goals at 6~     months, according to national clinical practice guidelines. The study hypothesis is that a~     higher proportion of patients with uncontrolled hypertension in the home blood pressure~     monitoring (HBPM) group will achieve their target blood pressure compared to those in the~     usual care (UC) group.~   "
183515|NCT01162746|"~     Age-related macular degeneration (AMD) is by far the most common disorder in the group of~     irreversible causes of visual disability. AMD leads to dysfunction and loss of photoreceptors~     in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease~     process and severely compromises the highly developed functions of the macula, such as~     perception of details, central fixation, color vision, and reading ability. AMD-related~     visual impairment is associated with a loss of autonomy and quality of life. Current~     therapeutic approaches target vascular endothelial growth factor (VEGF), which has been~     identified as a main cytokine in the pathogenesis of nAMD. Ranibizumab, the fab-fragment of~     an antibody targeting VEGF is approved for the treatment of nAMD applied intravitreally in~     monthly intervals until the disease activity is stopped. However, a significant proportion of~     patients with nAMD suffer from persistent or recurring disease with the need of continuous~     anti-VEGF therapy over months and years, often leading to irreversible changes in the~     photoreceptor layer and the pigment epithelium.~      Recent studies regarding the treatment of nAMD utilized different forms of therapies,~     combining photodynamic therapy with verteporfin (PDT) and ranibizumab, as well as therapeutic~     regimen containing steroids. Even though these studies did not provide evidence that~     combination therapies are superior to ranibizumab monotherapy, studies were only conducted~     with patients with previously untreated nAMD. Therefore, currently there is no alternative~     therapeutic approach for patients with recurrent or persistent form of nAMD after multiple~     treatments with ranibizumab monotherapy.~      The purpose of this study is to assess the treatment effect of reduced fluence PDT and~     intravitreal ranibizumab versus intravitreal dexamethasone and ranibizumab versus~     intravitreal ranibizumab monotherapy in patients with persistent or recurrent choroidal~     neovascularization (CNV) due to AMD.~      The investigators hypothesis is that these findings will offer new insights in the management~     of persistent or recurrent CNV secondary to AMD.~   "
183516|NCT01162733|"~     In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there~     is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put~     forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more~     rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then~     patients will in turn have better clinical outcomes and that the development of resistant~     organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged~     as one of the most deadly pathogens that are currently plaguing our patient population.~     Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is~     imperative that the ED physicians consistently and correctly dose vancomycin in order to give~     the patients the best chance to fight infection while helping to prevent further resistance~     in this already highly resistant organism. It is believed this study will reveal that the new~     dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more~     rapidly. This information will in turn help to convince ED physicians that a change in~     current clinical practice is warranted and ultimately lead to better clinically outcomes for~     the patients.~   "
183517|NCT01162720|"~     To establish whether a short duration of tourniquet application (from cement fixation to~     cement setting)is associated with better patient functional outcomes compared to a long~     duration of tourniquet application (from surgical incision to cement setting).~      It is hypothesised that tourniquet application during cement fixation only (approximately of~     20-30 min duration) will be associated with less pain and impairment than a longer tourniquet~     application (> 45 minutes).~   "
183518|NCT01162707|"~     The purpose of the trial is to evaluate the wireless monitoring of pulmonary artery pressure~     using the CardioMEMS HF Pressure Measurement System in adult subjects with NYHA Class III~     Heart Failure.~   "
183519|NCT01162694|"~     Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In~     order to prevent short and long term complications, patients need to monitor and control~     their blood sugar levels. In addition, they may need to have an ongoing communication with~     their doctor in order to modify treatment. In this study the investigators wish to compare~     two systems of monitoring and communication of blood sugar levels. The first is the use of~     continuous glucose monitoring system and the second is the use of an Internet-based glucose~     monitoring system. The investigators want to compare their effect and/or benefits.~   "
183520|NCT01162681|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of three~     different doses of A-623 administered in addition to standard therapy in subjects with active~     SLE disease~   "
183521|NCT01162668|"~     Objective: to assess the health and economic outcomes (weight lost, change in control of~     chronic diseases such as diabetes, quality of life, work productivity, health care cost, etc)~     associated with bariatric (weight-loss) surgery for 200 severely obese patients who undergo~     bariatric surgery as part of the Mississippi State Employees' Life and Health Insurance~     Plan's Obesity Treatment Program (OTP).~      2. Patient Characteristics: Inclusion criteria: Eligible bariatric surgical candidates who~     are enrolled in the OTP (100 patients per year for 2 years). The Plan's criteria includes,~     but is not limited to 1) enrollment in the plan for at least 12 consecutive months prior to~     September 1, 2009; 2) completion of the HealthQuotient health risk assessment through the~     Plan's wellness and health promotion program; 3) a Body Mass Index (BMI) of >40 kg/m2, or a~     BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or~     asthma; 4) two or more physician-supervised weight loss attempts within the last 24 months;~     5) age 18 years or older; and 6) consent to provide personal and medical information to the~     Plan. Prior to surgery, each site administers a psychiatric evaluation to ensure the patient~     is psychologically stable for surgery. Exclusion criteria: any patient who does not meet~     criteria above or who declines to participate. Surgeries will take place only at Certified~     Bariatric Surgery Centers of Excellence (COE), of which, there are currently 3 in the state.~     The 3 COEs exist with 4 outpatient medical offices (1 COE is composed of 2 independent~     surgeon practices) Patients will be recruited at each site once they are approved by the OTP.~      3. Design: prospective, observational, multi-center, longitudinal study of outcomes and~     resource utilization associated with OTP. Estimates of obesity and comorbidities' impact will~     be obtained from the outpatient medical office for the COEs. Medical charts, databases and~     medical/pharmacy claims will be the source of information. Surveys on quality of life,~     productivity, and patient satisfaction will be administered directly to patients. Database~     claim information will be obtained in future and is not a part of current IRB application.~      4: Procedures: After obtaining informed consent, patients will be administered surveys at~     baseline, as well as at follow-up visits. Additional data will be obtained via patient~     charts, databases, and medical/pharmacy claims.~   "
183575|NCT01161966|"~     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's~     Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule~     dose in fasted subjects.~   "
183947|NCT01157052|"~     The investigators hypothesize that Ca2+/MG2+ infusions will not have a significant effect on~     oxaliplatin pharmacokinetics.~   "
183522|NCT01162655|"~     Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is~     a prevalent and costly problem. This pilot study will compare the effectiveness of two brief~     (6 week) psychological interventions delivered to residents of rural Manitoba using~     Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants~     in the Telehealth condition will report significantly greater improvements in sleep~     parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity,~     and daytime fatigue than those in the Internet condition and that b)participants in the~     Telehealth condition will show better adherence to treatment and greater satisfaction with~     treatment than those in the Internet condition.~   "
183523|NCT01162642|"~     The purpose of this study is to determine whether green tea may lower the risk of certain~     cancers.~   "
183524|NCT01162629|"~     Dental implants are a valid and reliable method to replace missing teeth. The major~     requirement for their success is an adequate volume of bone into which they can be placed.~     One widely used method to augment bone at the time of placing the implant is to use a bone~     substitute rather than taking a block bone graft from the patient. Successful augmentation in~     the vertical direction has often proved difficult, however, the investigators have developed~     a technique to achieve this in the investigators patients using a synthetic bone substitute,~     Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another~     unnecessary surgical procedure.~   "
183525|NCT01162616|"~     Iron deficiency and iron deficiency anemia are two major public health problems in developing~     countries. In these countries, the use of monotonous plant-based diets, low in animal source~     food but high in iron absorption inhibitors such as phytic acid or polyphenol, lead to poor~     iron status or aggravate poor iron status caused by infections. In many West African~     countries sorghum is a major source of energy, protein, vitamins and minerals especially for~     the most poverty-stricken people. Some sorghum varieties are known to contain high levels of~     polyphenols which have an inhibitory effect on iron absorption in humans. Polyphenols are a~     huge group of plant metabolites with varying chemical structures. Depending on their~     structure, the level of complex formation with iron in the intestine and thus the negative~     effect on iron absorption is different.~      Micronutrient deficiency can be combated by fortification of plant-based staples.~     Fortification is a promising food-based approach which can be applied when other strategies~     fail to provide adequate levels of the respective micronutrient in the diet. To fortify foods~     with iron, a wide variety of different iron compounds have been used. The iron compound~     sodium iron ethylenediaminetetraacetic (NaFeEDTA) overcomes the inhibitory effect of phytate~     on human iron absorption. No information about the potential enhancing effect of NaFeEDTA in~     presence of polyphenol is available.~      The aims of the study are to investigate the effect of different sorghum polyphenol~     concentrations on human iron absorption and to investigate if the negative impact of the~     polyphenols can be overcome by using NaFeEDTA as iron compound. The study will include 32~     apparently healthy young women which will consume sorghum porridges with different polyphenol~     levels and sorghum porridges fortified with ferrous sulfate as compared to NaFeEDTA.~     Furthermore test meals with added vitamin C or added laccase will be compared to a control~     meal. Iron absorption will be determined by stable isotope technique.~   "
183526|NCT01162603|"~     -  Main objective is to compare the ability of Latanoprost 0.005% preservative-added~          ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution,~          both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in~          patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at~          first diagnosis. First efficacy variable will be the difference between mean nocturnal~          IOP values after three months of treatment: nocturnal IOP is defined as the mean value~          between 2AM and 6AM measurements.~        -  Secondary objectives will be the comparison between Latanoprost 0.005% and Tafluprost~          0.0015% ophthalmic solution about:~             -  Mean 24-hour IOP values after three months of treatment~             -  IOP values at these time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour),~               10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment~   "
183527|NCT01162590|"~     The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy~     adults aged 18 to 45 years in China.~   "
183528|NCT01162577|"~     The purpose of the Weigh2Quit study was to test in a randomized trial, a weight concerns~     intervention designed to reduce weight concerns that might impact cessation, increase~     physical activity and adherence to tobacco treatment, increase confidence in quitting,~     improve tobacco quit rates and decrease weight gain post-quit.~   "
183529|NCT01162564|"~     This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM~     laparoscopically. The study is not randomized and has a single treatment design assessing~     NG-TSM intra-operatively, its ease of use and handling characteristics.~   "
183530|NCT01162551|"~     This is a phase 2 study looking at efficacy and toxicity of oral sirolimus in combination~     with oral methotrexate in children with refractory/relapsed ALL or NHL.~      Secondary objectives include characterizing the trough levels produced by administration of~     oral sirolimus in children with refractory/relapsed ALL/NHL and to evaluate the effect of~     sirolimus on intracellular targets related to mTOR inhibition.~   "
183531|NCT01162538|"~     Pilot open label multicentric study~   "
183532|NCT01162525|"~     Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal~     urge continence at the Cantonal Hospital St. Gallen. During this introduction phase~     efficiency und adverse events will be monitored in this observational study.~   "
183533|NCT01162512|"~     The purpose of this study is to examine the effectiveness of a telephone-based physical~     activity (PA) intervention in obese adolescents attending a Health Weight Comprehensive~     Clinic. Secondary aims focus on increasing the amount of change in obesity markers, namely~     waist circumference and BMI z-scores. The investigators hypothesize the following: 1.The~     telephone-based PA intervention will increase PA levels above the mail group; and 2. The~     telephone-based PA intervention will provide changes in waist circumference and BMI z-scores~     above the mail group.~   "
183534|NCT01162499|"~     It has been proposed that the rapid gastric emptying of carbohydrate containing fluids into~     the intestine causes hyperglycemia followed by reactive hypoglycemia. The investigators have~     shown that glucagon-like peptide-1 (GLP-1) secretion in response to a glucose load is~     increased in children with Post-prandial hypoglycemia (PPH). This is a proof of concept study~     to investigate the causative role of GLP-1 in the pathophysiology of PPH after fundoplication~     by evaluating the effects of GLP-1 receptor antagonism on metabolic variables after a mixed~     meal.~      Hypothesis: In children with post-prandial hypoglycemia after fundoplication, antagonism of~     the GLP-1 receptor by exendin-(9-39) will elevate nadir blood glucose levels after a meal~     challenge and prevent post-prandial hypoglycemia.~   "
183594|NCT01161719|"~     The purpose of this study is to evaluate the effectiveness of group parent training taught~     through videoconferencing on ADHD treatment via a comparison between participants using~     traditional face-to-face parent training sessions and a group using teleconferencing.~   "
183536|NCT01162473|"~     Background and Rationale~      For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management~     includes identification of the causative food and avoidance. Specifically, among young~     children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%.~     Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators~     aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy.~      Main Objective~      The primary objective is to study the efficacy of milk oral immunotherapy.~      Target Population~      Children aged six to 17 years with a history of cow's milk allergy will be recruited from The~     Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.~   "
183537|NCT01162460|"~     The purpose of this study is to investigate the efficacy and safety of eslicarbazepine~     acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures.~   "
183538|NCT01162447|"~     The investigators aim to compare the levels of bone morphogenetic protein-4 and -7 (BMP-4 and~     7) in blood, follicular fluid and ovarian organ culture supernatant obtained from healthy~     subjects and polycystic ovarian syndrome (PCOS) patients.~   "
183539|NCT01162434|"~     Treatment resistant depression (TRD) is a major health concern, with 10% of patients with~     major depressive disorder not responding to conventional treatments. The investigators~     propose to compare the MRI (magnetic resonance imaging) brain scans of patients with TRD,~     which were collected during surgical planning for deep brain stimulation, with age, sex,~     handedness and education-matched healthy volunteer controls, to investigate anatomical~     differences, specifically the volume of certain brain structures.~   "
183540|NCT01162421|"~     A Canadian study to evaluate early use of adalimumab after methotrexate failure in early~     rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces~     joint damage in more participants when introduced earlier than in current practice.~   "
183541|NCT01162408|"~     Objective: To evaluate and compare the outcome predictive power of Acute Physiologic and~     Chronic Health Evaluation (APACHE) Ⅳ、Ⅲ、Ⅱ scoring systems for intensive ill patients in an~     independent medical intensive care unit (MICU), and explore the best time point when they can~     most accurately predict outcome.~      Design: Retrospective analysis of medical records. Methods and Materials: Collect data of~     patients admitted between July 2010 and July 2013 to the medical intensive care unit of the~     First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China. Patients with an ICU~     stay less than 4 hours and age less than 16 years were excluded. Calculate the APACHE Ⅳ、Ⅲ、Ⅱ~     scores and corresponding predictive mortality risks in the first 24 hours of ICU admission~     and the 3th, 5th, 7th, 14th, 21 th, 28th day or the day of transferred out of ICU or death.~     The predictive power of each model was assessed through the ratio of observed death rates and~     predictive death rates (Standardized mortality ratios, SMR), the calibration of observed and~     predictive death rates and the discriminative ability between survivors and non-survivors.~     Hosmer-Lemeshow test was employed for assessing the calibration and the discriminative~     ability was assessed by the area under the receiver operating curve. Compare the predictive~     power of the three models at different time points and explore the the best time point when~     they can most accurately predict outcome.~   "
183542|NCT01162395|"~     The main purpose of the study is to investigate the safety and tolerability of AZD3514 when~     given orally to patients with castration-resistant prostate cancer (CRPC)~   "
183543|NCT01162382|"~     This protocol, Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of~     Major Depressive Disorder (MDD): A Functional Connectivity Magnetic Resonance Imaging (fcMRI)~     Study, is an open-label pilot treatment study. The purpose of the present protocol is to~     treat participants with a diagnosis of Major Depressive Disorder with 4 weeks of rTMS,~     performing fcMRI and EEG studies prior to and following treatment to determine if treatment~     response is related to changes in fcMRI and/or EEG results. The investigators hypothesize~     that patients who respond to treatment will display changes in functional connectivity~     patterns thought to be related to the occurrence of depressive symptoms.~   "
183544|NCT01162369|"~     Delirium is an acute confusional state characterized by fluctuating mental status,~     inattention, and either disorganized thinking or an altered level of consciousness. This form~     of organ dysfunction occurs in up to 50% of hospitalized patients and is associated with~     worsening mortality, prolonged hospital length of stay, higher health care costs, and~     accelerated functional and cognitive decline. Despite the negative consequences of delirium,~     the majority of cases are unrecognized by hospital physicians because it is not routinely~     screened for. In an effort to facilitate delirium screening, we sought to validate two brief~     delirium assessments (<2 minutes) in the hospital setting.~   "
183545|NCT01162356|"~     Since the introduction of vitrectomy in 1971, this procedure has become the third most~     frequently performed ophthalmic surgery. Approximately 225,000 vitrectomies are performed~     annually in the United States and indications continue to expand. Known long-term~     complications of vitrectomy are relatively few and include retinal detachment and cataract~     formation. Although much has been written in the literature concerning acute rises in~     intraocular pressure (IOP) in the immediate postoperative period, there is surprisingly~     little information on long term IOP outcomes after vitrectomy. A recent report by Chang given~     at the LXII (62) Edward Jackson Memorial Lecture hypothesized a causal relationship between~     vitrectomy and open-angle glaucoma (OAG) via oxidative stress exacerbated by removal of the~     crystalline lens. A second report by Luk and colleagues reported similar conclusions in a~     modified cohort. Both studies, were retrospective in nature and did not perform baseline~     evaluations to exclude pre-existing glaucoma. Furthermore neither study accounted for natural~     history. Finally, our analysis has not reproduced similar results.~      The primary purpose of this study is to analyze the full spectrum of optic nerve and macular~     changes between vitrectomized study eyes and their non-vitrectomized fellow eyes to control~     for natural history. Baseline evaluations will include examination by fellowship trained~     retina and glaucoma specialists, fundus photography, autofluorescence, optical coherence~     tomography (macula and optic nerve) and automated visual field testing. At 3 month then~     annually for 5 years after vitrectomy surgery, the cohort will undergo similar evaluation.~   "
183790|NCT01159145|"~     The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated~     oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who~     are classified by the genotype of CYP2C19 by the assessment of percentage of time with~     intragastric pH>4 during 24 hours after dose on day 5.~   "
183546|NCT01162343|"~     Delirium is an acute confusional state characterized by altered or fluctuating mental status,~     inattention, and either disorganized thinking or an altered level of consciousness. This form~     of organ dysfunction occurs in up to 10% of older emergency department (ED) patients and is~     associated with worsening mortality, prolonged hospital length of stay, higher health care~     costs, and accelerated functional and cognitive decline. Despite the negative consequences of~     delirium, the majority of cases are unrecognized by emergency physicians because it is not~     routinely screened for. In an effort to facilitate delirium screening, the investigators~     sought to validate three brief delirium assessments in the ED setting.~   "
183547|NCT01162330|"~     This study will look at the feasibility and acceptability of testing newborn babies who are~     referred after their newborn hearing screen for an infection called congenital~     Cytomegalovirus (cCMV). Around 1 in every 100 to 200 babies is born with this virus, and~     although most remain well it causes 1 in 5 cases of childhood deafness. Knowing that a baby~     is infected shortly after birth could have significant benefit since a treatment is now~     available, but screening programs need to be feasible and acceptable. This study aims to~     evaluate targeted screening for cCMV by taking samples (saliva and urine) from babies who do~     not pass their newborn hearing screening. The investigators want to see if we can find a~     quick, reliable and parentally acceptable way to screen babies who fail their hearing test~     for this virus.~   "
183548|NCT01162317|"~     Objective: To evaluate real acupuncture, as compare to sham acupuncture, in improving~     persistent sleep difficulties in veterans with mild traumatic brain injury (mTBI) Design:~     Randomized, blinded, sham-controlled clinical trial Setting: Outpatient clinic at a major VA~     medical center in Southeast USA Participants: Sixty veterans aged 24-55 (mean 40) with~     history of mTBI at least 3-month and beyond, suffering from sleep difficulties refractory to~     regular care and sleep education, as indicated by a global Pittsburgh Sleep Quality Index~     (PSQI) score of 14.25 + 3.23 pre-intervention (baseline). They were randomized into 2 groups,~     real acupuncture versus sham acupuncture, and stratified by Post-traumatic stress disorder~     (PTSD) diagnosed by PTSD CheckList - Military Version (PCL-M).~      Intervention: Real or sham acupuncture with both standardized and individualized acupoints~     selection. All subjects were informed that the treatments, if effective, may improve symptoms~     such as pain, anxiety or depression other than sleep; real acupuncture may not be effective~     in some individuals, and sham acupuncture may as well be effective by mind-body interactions.~      Outcome Measures: Primary outcome measure was global PSQI score change after intervention as~     compared to baseline. Secondary outcome measure was wrist-actigraphy sleep latency, sleep~     efficiency, wake after sleep onset (WASO), and sleep duration. PTSD was analyzed as a~     co-variant.~   "
183549|NCT01162304|"~     The investigators hypothesize that subjects will have greater pain relief when taking~     IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying~     amount of medication at six different points over the course of a day will allow patients to~     take as much (or as little) medication as they need to control their pain. In addition, the~     ability to vary the medication doses in this way will give them a greater sense of control,~     which will also contribute to greater pain relief. Similarly, the investigators predict that~     patients will show greater benefits with IR-oxycodone on the measures of physical and~     emotional functioning. Because there is relatively little data on sleep apnea in chronic pain~     patients (Webster et al., 2008), these assessments are exploratory and not hypothesis-based.~     Finally, although it is typically thought that the abuse liability of IR-opioid medications~     is greater than for ER-medications, the data on which this belief are based have not involved~     systematic studies of patients with chronic pain; the assessments of abuse liability will~     therefore also be exploratory.~   "
183550|NCT01162291|"~     The purpose of this experimental pilot study is to assess a positive effect of higher~     injection volumes of fluid (physiological sodium) in the elbow-flection-muscle (M. biceps~     brachii) and elbow flexion and extension movements on fluid distribution in the muscle~     tissue.~   "
183551|NCT01162278|"~     Patients that have had staging studies identifying them as AJCC stage IV with up to five~     liver metastases will be considered for the study. About 60 patients will take part in this~     study at UT southwestern, Parkland Health & Hospital System, and Methodist Richardson Cancer~     Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7~     to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last~     for approximately 1 day and the follow-up portion of the study will last 5 years.~   "
183552|NCT01162265|"~     The objective of this study is to assess the efficacy of the two current TB (tuberculosis)~     blood tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test~     (Mantoux Tuberculin Skin Test (TST)), for predicting active tuberculosis among those at~     increased risk of TB. Those at increased risk are defined as either newly arrived immigrants~     or people who have been in contact with TB cases. The study will also provide information on~     the cost effectiveness of different testing strategies, such as the two step testing approach~     recommended by NICE. The study is to be funded by the NIHR Health Technology Assessment~     programme.~      10,000 participants will be recruited from 12 hospitals and a network of GP surgeries in~     London. All participants will have the skin test and blood taken for both assays. Disease~     status of participants will then be followed up for an average of 24 months using the~     national register of clinical reports, a phone call and the national microbiological~     database. The risk of developing active disease is highest in the first two years after~     exposure. During followup there will be no additional diagnostic procedures unless symptoms~     occur, i.e. in line with current NICE policy. A sub group of patients, selected as a random~     25% of participants, will have a repeat IGRA test shortly after the first test to investigate~     whether the skin test affects the result of the blood test.~   "
183553|NCT01162252|"~     The purpose of the study is to examine and compare the effects of the Mindfulness-Based~     Stress Reduction (MBSR) program and the Living Well (LW) program on adults with psoriasis in~     terms of how these programs may affect their psoriasis, immune function, physical and~     emotional health, and well-being.~   "
183595|NCT01161706|"~     The purpose of the investigators study is to investigate the impact of a commercial vegetable~     juice on dietary vegetable intake and select cardiovascular risk factors in a generally~     healthy population. The study was a 12 week study with 3 groups who received 0, 8 or 16 fluid~     ounces daily of vegetable juice, along with education on the DASH (Dietary Approaches to Stop~     Hypertension) diet. All participants came in for 3 study visits at 0, 6 and 12 weeks into the~     study.~   "
183554|NCT01162239|"~     The research is based on a chronic disorder model of cigarette smoking which suggests that~     long-term treatment targeted to prevent relapse may be useful. Based on this model, the~     investigators have developed a relapse prevention treatment to intervene on five areas~     important in relapse prevention, including fluctuating motivation, depression, withdrawal,~     weight gain, and social support. This treatment protocol has produced high long-term~     abstinence rates when implemented in a clinical research setting. The current study will~     evaluate the treatment model when implemented in a medical outpatient setting. This study~     will test a series of hypotheses comparing the efficacy of the relapse prevention treatment~     to other extended treatments. All participants will be assessed at baseline on demographics,~     smoking behaviors, nicotine dependence, depression, alcohol and other drug history and~     problems, mood disturbance, treatment support, stress, health status, and motivation for~     change. Participants will be randomly assigned to one of four treatment conditions. All~     participants will receive 12 weeks of combined pharmacological treatment (varenicline) and~     behavioral treatment (five individual counseling sessions). Following this brief treatment,~     participants will be randomly assigned to one of four treatment protocols~        1. Monthly Brief Contact or~        2. Extended Non-Specific Behavioral Treatment or~        3. Extended Relapse Prevention Treatment or~        4. Extended Relapse Prevention Treatment + availability of varenicline treatment. Each~          extended treatment protocol is 40 weeks in duration. All participants will be assessed~          at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.~   "
183555|NCT01162226|"~     This study will be carried out to determine the effectiveness of in-home computer games~     played by a person with Parkinson's disease for 50 minutes 3 times a week on measures of~     standing and walking balance.~   "
183556|NCT01162213|"~     The investigators hypothesize that acute and short term consumption of a lychee fruit~     extract, particularly rich in low molecular weight dietary flavanols, will improve vascular~     function and reduce platelet reactivity.~   "
183557|NCT01162200|"~     By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®,~     the current protocol attempts to mimic or improve the excellent local control rates seen in~     treatment of early stage breast cancer while attempting to increase convenience, limit~     invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation~     treatment.~   "
183558|NCT01162187|"~     All contemporary guidelines for secondary prevention in acute coronary syndromes recommend a~     combination of aspirin, beta-blockers, ACE-inhibitors and statins. Yet underutilisation of~     these drugs is common. We do not know in detail what drives underutilisation, nor what its~     long term consequences are for survival after discharge from hospital. Also unknown is~     whether potential adverse effects of underutilisation are the same for individual secondary~     prevention drugs.~      This study will assess the impact of secondary prevention underutilisation on survival.~   "
183559|NCT01162174|"~     The investigators hypothesize that acute consumption of Oligonol, a patented lychee fruit~     extract (Amino Up Chemical Co.) particularly rich in low molecular weight flavanols, will~     improve endothelial function, reduce platelet reactivity and increase circulating levels of~     flavonoids after a single intake.~   "
183560|NCT01162161|"~     In this mono-center prospective study, the impact of changes in the sphingolipid metabolism~     in patients with pulmonary edema will be investigated.~   "
183561|NCT01162148|"~     Lung transplantation (LT) is now an established treatment option for patients with a wide~     variety of end-stage lung diseases- aims to improve quality of life and survival. Pulmonary~     rehabilitation (PR) is widely recognized as an important component of care of patients with~     chronic obstructive pulmonary disease (COPD), it improves dyspnea, exercise tolerance,~     quality of life, and reduces healthcare resource utilization.~      The goal of pulmonary rehabilitation following lung transplantation is to enhance the~     physiological and functional benefits resulting from surgery. Inspiratory muscle Training~     (IMT) is defined as any intervention with the goal of training the inspiratory muscles. IMT~     can improve inspiratory muscles strength, endurance and exercise capacity in adults with~     COPD. IMT provides additional benefits to patients undergoing PR program and is worthwhile~     even in patients who have already undergone a general exercise reconditioning (GER) program.~     IMT will provide additional benefits (together or without) PR to patients following lung~     transplantation. No formal guidelines exist regarding the optimal methods of exercise~     training component of pulmonary rehabilitation for patients recovering from lung~     transplantation. This study will evaluate the unique influence of IMT in Patients Following~     Lung Transplantation.~   "
183562|NCT01162135|"~     The purpose of this study is to assess the effectiveness of dioxin on prohibiting prostate~     cancer progression as measured by PSADT (prostate-specific antigen doubling time).~   "
183563|NCT01162122|"~     The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted~     subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing~     process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with~     respect to immunogenicity in subjects aged 65 years and older. The active comparator~     non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United~     States and will be used to provide a comparative assessment for immunogenicity and safety.~   "
183564|NCT01162109|"~     Sepsis is a clinical syndrome often caused by a bloodstream infection that results in a~     common set of symptoms termed systemic inflammatory response syndrome (SIRS). Severe sepsis~     (sepsis with organ failure) is the leading cause of death in critically ill patients in the~     US. Most patients with severe sepsis need to be treated in the intensive care unit with~     mechanical ventilation and intravenous antibiotics. Between 30 to 50% of all severe sepsis~     patients die and quality of life in survivors is substantially reduced. New therapies are~     needed to improve clinical outcomes in patients with sepsis.~      A new area of interest in the treatment of critical illness is pharmaconutrition, in which~     micronutrients (like zinc) are studied and administered to determine if they affect the~     inflammatory response or immunologic processes in critical illness. The FDA does not regulate~     micronutrients and does not require rigorous pharmacokinetic (the study of how a drug or~     nutrient is metabolized in the body) testing so it is not clear how to dose micronutrients in~     critically ill patients. It is also not clear if critically ill patients would metabolize~     these micronutrients differently than healthy people and would need different dosing levels.~     This is true of zinc, the focus of this research study.~      Zinc is essential for normal immune function, oxidative stress response, and wound healing,~     and its homeostasis is tightly regulated. Zinc deficiency occurs in >10% of Americans and~     leads to loss of innate and adaptive immunity and increased susceptibility to infections. The~     symptoms of zinc deficiency are similar to many of the symptoms of SIRS and there is strong~     biologic rationale to suggest that the zinc deficiency seen in nearly all sepsis patients may~     contribute to the development of sepsis syndrome and to the immunoparalysis common in~     sepsis patients~      This study has three specific aims, 1) to perform a phase I dose-finding study of intravenous~     zinc in mechanically ventilated patients with severe sepsis; 2) to define the pharmacokinetic~     of intravenous zinc in mechanically ventilated patients with severe sepsis compared to~     healthy controls; and 3) to investigate the impact of zinc on inflammation, immunity, and~     oxidant defense in patients with severe sepsis.~      A total of 40 critically ill patients from the FAHC intensive care units and 15 healthy~     controls will be enrolled in the study. The critically ill patient population will be divided~     into 4 dosing groups of 10 subjects (7 randomized to zinc and 3 to saline placebo). Group 1~     will receive 500mcg/kg IBW/day elemental zinc in divided doses every 8 hours. If the 50th~     percentile of the normal plasma zinc range (110mcg/dL) has not been achieved in all patients~     by 7 days and there are no safety concerns, sequential groups of patients will receive~     increasing doses in 250mcg increments to the ceiling dose. Groups 2 through 4 will receive~     750, 1000, and 1250mcg/kgIBW/day elemental zinc, respectively. Each participant will receive~     the intravenous zinc or placebo for a total of 7 days unless they die or leave the ICU~     earlier. Pharmacokinetic testing will be obtained from 40 of the critically ill subjects and~     in 15 healthy controls. Additional blood will be drawn during the infusion protocol to~     investigate the impact of zinc on inflammation, immunity, and oxidant defense.~   "
183565|NCT01162096|"~     Many patients with hematological malignancies (leukemia, lymphoma, multiple myeloma) cannot~     undergo hematopoietic stem cell transplantation (HSCT) because they do not have a well~     matched donor. HSCT from partially matched family donors (haploidentical HSCT) is an option~     for most patients but has been associated with poor outcomes. This study was designed to test~     whether using an exact amount of a donor's lymphocytes (white cells) and dividing the~     transplant process into 2 steps, would increase overall survival by decreasing complications.~     The therapy is reduced intensity so it is targeted, but not limited to, patients over the age~     of 65 or those who have had previous transplants.~   "
183576|NCT01161953|"~     Primary Biliary Cirrhosis (PBC) is a progressive liver disorder of unknown cause. Current~     evidence suggests that genes, the genetic material we inherit from our parents, in~     combination with environmental factors, likely play an important role in the development of~     PBC.~      This study is being done to investigate whether genes make people more likely to develop PBC.~     Discovery of these proposed genes will help us better understand how PBC developes, and~     subsequently, to apply new approaches for its prevention, diagnosis and treatment.~   "
183566|NCT01162083|"~     Cardiopulmonary exercise testing (CPET) is a safe, noninvasive investigation where a patient~     walks on a treadmill or cycles whilst attached to an ECG and with a mask that measures the~     air breathed in and out. It has numerous clinical uses, such as diagnosing the main cause in~     patients with breathlessness, deciding on timing for heart transplantation and assessing~     whether patients are safe for a general anaesthetic.~      A patient's peak oxygen consumption, the maximum amount of oxygen taken up by the blood from~     the lungs when breathing increases during exercise, is the main measurement taken from CPET.~     It is low in heart disease and has been used to predict the risk of death and therefore plan~     treatments for patients. However this is also low in numerous other diseases including lung~     disease; reduced oxygen consumption in patients with two conditions may be wrongly thought to~     be because of the heart leading to inappropriate action and distress to the patient.~      Newer measurements of exercise capacity from the same exercise test are better at predicting~     death in heart failure.~      We propose that they are more specific for heart failure over other diseases, for example~     lung disease, when compared with peak oxygen consumption, and are superior when a single best~     test for heart failure is required.~      This research aims to identify which measurement of exercise capacity is most specific for~     heart failure. We will perform the test on many patients with different diseases, and before~     and after procedures such as the implantation of special pacemakers, and heart valve~     operations. This should lead to a more accepted use of this investigation and the more~     appropriate identification of which patient should have which procedure.~   "
183567|NCT01162070|"~     The Uveitis, the inflammation of the uvea, is a rare disease with an incidence of 52/100,000~     inhabitants per year and a prevalence of 115 / 100,000 inhabitants per year.~      The causes of uveitis are numerous and include infectious diseases, systemic and neurological~     diseases, ophthalmic entities, neoplasia, and drug-related reactions. The etiological~     diagnosis is important both for prognosis and therapeutics.~      However, clinical evaluations to establish etiological diagnosis are not standardized. Some~     authors suggest a minimalist examination, common to all kinds of uveitis. On the other hand,~     others propose an evaluation guided by the anatomo-clinical type of uveitis.~      We conducted a retrospective study to assess the contribution of complementary examinations~     to etiological determination. In this study, we found that most patients benefited from a~     wide paraclinical evaluation compared to what is usually described in the literature.~     Complementary examinations were mostly systematic, without any clinical or ophthalmological~     elements of orientation. This study highlighted the lack of contribution of some~     examinations.~      Using these results, and the literature analysis, we designed a diagnostic algorithm adapted~     to the anatomo-clinical type of uveitis.~      Moreover, we found that the average cost per patient was estimated at €290.51 with the~     algorithm compared to €560.83 without it.~      We would like to carry out a new study to estimate the efficiency as well as the~     medico-economic impact of the use of a standardized strategy for the etiological diagnosis of~     uveitis, compared with a free strategy.~      Hypothesis:~        -  The standardized strategy for the diagnostic of uveitis is at least as efficient as the~          free one, and costs half as much.~        -  The examinations prescribed, except for those from the standardized strategy, do not~          contribute to etiological determination.~   "
183568|NCT01162057|"~     The inner ear contains transporters that are responsible for maintaining a strict homeostatic~     environment, necessary for transmission and transduction of sound waves. Hemodialysis affects~     the body's composition including the aspects regulated by these transporters (pH, osmolarity,~     Na, K). We wish to observe if hemodialysis affects hearing, and if so, by which parameters.~   "
183569|NCT01162044|"~     PTSD is a common and distressing possible outcome following exposure to a traumatic event.~     Recent studies show that memory processes may be central to the development of the disorder,~     and interrupting the consolidation of traumatic memories may prevent the disorder from~     developing. Specifically the use of a visual spatial task has been shown to reduce a key~     characteristic of PTSD, intrusions, in non-clinical populations. This study aims to~     administer a visual spatial task to recent trauma survivors in the Emergency Room, and~     compare PTSD and symptoms development in these patients as compared to a control group who~     did not carry out the task. The study hypothesizes that the task will result in less PTSD,~     lower levels of intrusions, dissociation and pain.~   "
183570|NCT01162031|"~     We hope to learn more about the clinical efficacy of bortezomib in T-cell prolymphocytic~     leukemia. Patients will be selected as a possible participant in this study because they have~     a bone marrow disorder known as T-cell prolymphocytic leukemia (T-cell PLL) which does not~     tend to respond well to conventional treatment with chemotherapy.~   "
183571|NCT01162018|"~     The proposed study will recruit 60 women with breast cancer who finished undergoing treatment~     who complain of persistent insomnia problems that began with onset of their cancer diagnosis.~     The eligible women would be randomized and stratified by sleep problems to two arms:~     (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study~     (we anticipate about 20% attrition rate). The study interventions will begin after patients~     completed their treatment. The placebo control for acupuncture will be a validated sham~     acupuncture control Assessments will be made with daily diaries and with weekly~     questionnaires. PSG data will be collected on the subsample of the population. Data will be~     gathered via pencil-and-paper measures before, during, immediately following, one month~     following the completion of treatment and six months after the conclusion of treatment. In~     addition, actigraphy data (objective sleep continuity data) will be acquired prior to and~     following treatment~   "
183572|NCT01162005|"~     To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the~     investigators designed this prospective study. The investigators will enroll 100 children~     with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated~     with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level~     between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies~     will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs,~     multivitamins and lipid-lowering agents.~      Follow-up is every second week for the first 4 weeks, then monthly. After initiation of~     tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.~   "
183573|NCT01161992|"~     Primary Sclerosing Cholangitis (PSC) is a progressive liver disorder of unknown cause.~     Current evidence suggests that genes, the genetic material we inherit from our parents, in~     combination with environmental factors, likely play an important role in the development of~     PSC.~      This study is being done to investigate whether genes make people more likely to develop PSC.~     Discovery of these genes will help us to better understand how PSC developes and~     subsequently, to apply new approaches for its prevention, diagnosis and treatment.~   "
183574|NCT01161979|"~     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's~     Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule~     dose in subjects fed a high standard fat meal.~   "
183577|NCT01161940|"~     This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories~     Limited under fasting conditions~   "
183580|NCT01161901|"~     The ARDS has a clinical definition with criteria of the American-European Consensus~     Conference (1994). This definition inconveniently applies to a lot of patients with acute~     respiratory failure.~      We know that there are 2 forms of ARDS morphology on CT scan : lobar attenuation (loss of~     aeration with no concomitant excess in lung tissue) predominating in the lower lobes and non~     lobar attenuation with diffuse and massive loss of aeration with excess lung tissue in all~     the pulmonary parenchyma.~      Today, plasmatic biomarkers are used as prognostic and diagnostic markers of ARDS. Some of~     them are characteristics of the different damages in the ARDS (alveolar epithelium and~     vascular endothelium lesions) : sRAGE, SP-D, PAI 1 and sICAM 1.~      This study's hypothesis is that patients with ARDS criteria and lobar morphology on CT scan~     present loss of aeration but no inflammatory pulmonary oedema, whereas patients with non~     lobar morphology on CT scan present both characteristics.~      The primary purpose of our protocol is to show that the patients who respond to ARDS criteria~     and have a lobar morphology on CT scan do not have an elevation of the biomarkers specific to~     the pulmonary aggression of ARDS.~   "
183581|NCT01161888|"~     The purpose of this study is to determine if topical imiquimod is effective in the~     pathological complete regression of lentigo maligna.~   "
183582|NCT01161875|"~     Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction~     following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of~     the facial mask used to perform non invasive ventilation and induces air leaks. The use of a~     helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface.~     However, the high dead space related to helmet volume is responsible for asynchrony between~     patient demand and ventilatory support delivery. The investigators hypothesized driving the~     ventilator based on a neural signal (diaphragm electrical activity) would reduce~     patient-ventilator asynchronies.~   "
183583|NCT01161862|"~     The investigators hypothesize that our closed-loop glucose-control system can provide BG~     control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the~     input signal to the controller.~   "
183584|NCT01161849|"~     Laparotomy performed for both emergency of elective surgery may by complicated by~     intrabdominal collection, anastomotic leakage, infarction and others. This conditions are~     able to induce peritoneal inflammation. Inflamed peritoneum are able to produce excess of~     lactate that the investigators can measure by collecting fluid from peritoneal drainage.~      Drainage were left in abdomen for monitoring intrabdominal condition until the passage of~     stool or flatus. Minimum drainage of serum is present daily also in uncomplicated post~     operative period.~      Serum lactate relates with increased systemic anaerobic metabolism such as SIRS, sepsis and~     systemic hypoperfusion and it is easy to measure with a blood gas analysis.~      The investigators hypothesized that the increases of peritoneal/ serum lactate ratio could be~     an earlier, sensible, non-invasive, and economical marker of post surgical complications. The~     decision whether and when to perform a relaparotomy in secondary peritonitis is largely~     subjective and based on professional experience. Actually no existing scoring system aids in~     this decision.~      The aim of this study is to demonstrate that this ratio could be and useful tool for the~     surgeon in this decisional process.~   "
183585|NCT01161836|"~     This is a Phase 1, multi-center, open-label study.~      During Segment 1, patients are administered a single IV administration of [14C]-iniparib.~      During Segment 2, patients are administered iniparib with or without additional chemotherapy.~     Acceptable chemotherapy regimens is limited to those for which previous experience with~     iniparib exists.~   "
183586|NCT01161823|"~     After menopause the coronary artery disease (CAD) risk increases rapidly to an equivalent~     risk of men with the same age. The rising incidence of CAD could be a subsequent decline of~     endogenous estrogen blood levels after the menopause. Estrogen leads to vasodilation and~     vasoprotection through an increase of Nitric Oxide (NO). NO deficiency results in endothelial~     stiffness and dysfunction with a subsequent initiation of atherosclerosis. Menopausal status~     is associated with an increase of the sympathetic nerve activity leading to hypertension,~     increased heart rate and palpitations. Recent studies show an importance of vasoactive~     substances (e.g. NO) in the physiology of hot flashes. Thus, hot flashes may be associated~     with a decreased NO production and release. Additionally, it is well known that during and~     after menopause women experience a change in sexual function (declined libido and increased~     dyspareunia) due to decreasing estrogen blood levels. Recently, a new angiostatic parameter -~     Endostatin (ENST) - has been shown to be involved in EC function. There is also evidence that~     ENST levels increase during NO stimulation. Nebivolol, a ß-blocker of the third generation,~     has been shown to release NO to a significant amount in the EC. It is safe and effective in~     reducing blood pressure to the target level. However, there is no data of the effect of~     Nebivolol on sexual function, on clinical symptoms (palpitations, increased heart rate and~     hot flashes) and ENST in postmenopausal women. The present study investigates the effect of a~     NO-releasing ß-blocker compared to a phytoestrogen therapy considering clinical signs of~     menopause such as palpitations, hot flashes and sexual functioning in postmenopausal women.~     Therefore, the use of a ß-blocker treatment is warranted. Further, this study tries to~     elucidate the role of NO release in postmenopausal symptoms and may gain new insights in the~     pathophysiology of hot flashes and increased sympathetic nerve activity. Thus, this trial~     should explore an advantage of Nebivolol therapy in contrast to a phytoestrogen therapy.~      Null hypothesis: Climacteric disorders as measured by the MRS-II in patients with a Nebivolol~     therapy is not lower than in patients with phytoestrogen therapy. Alternative hypothesis:~     Climacteric disorders in patients as measured by the MRS-II with a Nebivolol therapy is lower~     than in patients with phytoestrogen therapy.~   "
183587|NCT01161810|"~     This project will develop a descriptive database of patient information and patient outcomes.~     This database will be used to determine the association of time spent in rehabilitation and~     patient outcomes, to relate patient acuity to burn scar contracture development and to~     establish minimal time requirement guidelines for various rehabilitation patient outcomes.~   "
183588|NCT01161797|"~     The aim of this study was to evaluate the correlation between 1,5-Anhydroglucitol in patients~     with HbA1C <7%, and glycemic excursions as assessed by the continuous glucose monitoring~     system compared to fructosamine.~   "
183589|NCT01161784|"~     The purpose of this study is to determine the effects of daily consumption for 4 weeks of a~     fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain~     Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.~   "
183590|NCT01161771|"~     This is a multicenter evaluation of the effects of the cataract extraction and limbal~     relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.~   "
183591|NCT01161758|"~     Passive accessory cervical mobilization is widely used as a clinical approach to the~     management of musculoskeletal pain of spinal origin. The purpose of the study is to determine~     if passive cervical mobilization can improve motor function in situations where motor~     performance is not impaired by the presence of pain.~   "
183592|NCT01161745|"~     The investigators want to identify that whether PD-1/PD-L1 pathway will change in human~     sepsis, and whether PD-1/PD-L1 pathway play an important role in sepsis induced~     immunosuppression.~   "
183596|NCT01161693|"~     This study will randomly allocate 180 women undergoing elective C-sections under combined~     spinal epidural (CSE) Anesthesia at BC Women's Hospital to one of three groups: Standard~     Pillow under Head (Control), Head Elevated in Ramped Position immediately after regional~     anesthesia (HERP), or Head Elevated Ramped Position horizontally- Horizontal until~     establishment of anesthesia and then head elevated for the surgical procedure (HERP-H). The~     subjects will be monitored for blood pressure changes (hypotension), comfort levels and time~     to adequate level of the anesthetic block obtained with the CSE. The study will determine if~     positioning a parturient in the ramped position using an elevation pillow will significantly~     increase the time for anesthesia to reach the dermatome level of T4 as well as whether it~     increases maternal comfort and provides a better airway position for the parturient.~   "
183597|NCT01161680|"~     This project will examine the current diagnosis and treatment of bone health in patients with~     obstructive airway disease. Patients will be referred to The Osteoporosis Centre of BC (OCBC)~     by their respirologist to be assessed for osteoporosis including Dual Energy Xray~     Absorptiometry (DXA) scan. Previous chest xrays and will be accessed and examined for~     vertebral fractures, diagnostic of osteoporosis. The lung and bone data will be entered into~     a database. This will allow us to explore the relationship of lung disease parameters to~     osteoporosis predictors, eventually determining a respirology patient population who are at~     high risk of fracture. Longitudinal evaluation of bone health and its relationship to~     respiratory parameters over time will be explored by follow-up evaluations at 12 and 24~     months.~   "
183598|NCT01161667|"~     The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride~     Tablet under fasted conditions.~   "
183599|NCT01161654|"~     The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride~     Tablet under fed conditions.~   "
183600|NCT01161641|"~     Protein Losing Enteropathy (PLE) is a serious medical condition that may develop in children~     and adults with congenital heart disease for which a palliative procedure known as the~     Fontan procedure has been performed. The loss of serum proteins into the gastrointestinal~     tract that is associated with PLE can cause serious symptoms and life-threatening~     complications. A number of clinical studies have suggested that heparin administration can~     have clinical benefit in children with PLE, however the risk of bleeding associated with the~     administration of heparin is an important concern and commonly limits its administration.~     ODSH is a desulfated heparin with minimal anticoagulation properties but which, in~     pre-clinical studies, appears to have the potential to replace heparin and greatly reduce the~     risk of bleeding. This open label study is to assess the safety and evidence of therapeutic~     effect of the administration of ODSH as a 4-day continuous intravenous infusion in patients~     with an exacerbation of their PLE.~   "
183601|NCT01161628|"~     Rituximab is an attractive agent to bring to the upfront treatment of chronic~     graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy~     in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing~     agent in other autoimmune diseases. The investigators hope to demonstrate that Rituximab has~     significant activity in cGVHD when utilized early in the course of the process. In addition,~     the investigators hope to show that the early use of Rituximab may allow for the earlier~     discontinuation of immunosuppression while obviating the need for long courses of systemic~     corticosteroids, which should translate into reduced treatment-related morbidity and~     mortality associated with cGVHD.~   "
183602|NCT01161615|"~     A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the~     Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the~     Treatment of Tendonitis and Bursitis of the Shoulder.~   "
183603|NCT01161602|"~     The purpose of this study is to determine if pumosetrag is effective in treating~     Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD~     symptoms and are currently taking an acid suppression therapy, such as a Proton Pump~     Inhibitor (PPI).~   "
183604|NCT01161589|"~     The purpose of this clinical study is to collect simultaneous, multiple view cardiac signals~     representing both transvenous ICDs (T-ICD) and sensing vectors from the subcutaneous~     implantable defibrillator system (S-ICD). Upon completion, this data will represent the first~     true database capable of comparing detection characteristics of transvenous and subcutaneous~     ICDs. Future protocols will be created to dictate the specific methods of such comparisons.~   "
183605|NCT01161576|"~     This is a proposed follow up study on the investigators previous gene transfer human clinical~     trial entitled Administration of a Replication Deficient Adeno-associated Virus Gene~     Transfer Vector Expressing the Human CLN2 cDNA to the Brain of Children with Late Infantile~     Neuronal Ceroid Lipofuscinosis (Weill Cornell IRB# 0401007010). As in the previous study,~     the investigators propose to administer a biologic by direct gene transfer into the brain and~     assess its safety on children with a fatal genetic disease of the central nervous system~     (CNS). The disease is Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL, a form of Batten~     disease). This will be accomplished by using delivery of a gene (method called gene transfer)~     to administer to the brain an experimental drug called AAVRh.10CUhCLN2, a gene transfer~     vector.~   "
183606|NCT01161563|"~     The purpose of this study is to compare how subjects feel after receiving injections of two~     different types of GnRH six months apart. One injection is given under the skin of the~     abdomen, and the other one into the muscle of the buttock or thigh.~   "
183607|NCT01161550|"~     This study will evaluate the investigational drug Midostaurin in various doses given with~     ATRA and CLAG chemotherapy. Midostaurin is a FLT3 inhibitor that is activated or~     overexpressed in a significant proportion of AML patients. Research has shown that~     midostaurin and drugs like midostaurin may work better in combination with chemotherapy, like~     CLAG. CLAG is a combination of cladribine, cytarabine, and G-CSF which is approved by the FDA~     and used to treat AML.~   "
183636|NCT01161173|"~     This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in~     routine clinical practice as second-line treatment in patients with recurrent or metastatic~     non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1~     course of standard systemic chemotherapy, experienced disease progression, and who are~     receiveingTarceva in a second-line setting. Patients will also be followed through third-line~     treatment if there is disease progression on Tarceva therapy.~   "
183608|NCT01161537|"~     Cystic Fibrosis (CF) is caused by mutations in the cystic fibrosis transmembrane conductance~     regulator (CFTR) gene. The encoded protein, CFTR, is an epithelial chloride ion channel~     responsible for aiding in the regulation of salt and water absorption and secretion in~     various tissues. Although the disease affects multiple organs, the leading cause of mortality~     is the progressive loss of lung function. Obstruction of airways with thick mucus, chronic~     bacterial infection of the airways, and inflammatory response are all thought to play a role~     in causing lung damage. Through its function as a chloride channel, CFTR is believed to be~     integral in epithelial ion and water transport and hence, maintaining the normal hydration of~     lung secretions.~      VX-770 (ivacaftor) is a potent and selective potentiator of wild-type, G551D, F508del, and~     R117H forms of human CFTR. Based on in vitro studies and pharmacologic, pharmacokinetic (PK),~     and safety profiles, VX-770 has been selected for clinical development as a possible~     treatment for patients with CF.~      Hyperpolarized noble gas magnetic resonance imaging (HG-MRI) is a promising new means of~     assessing lung function by direct imaging of certain non-radioactive isotopes of an inert~     noble gas, such as helium or xenon. Through this technique, high-resolution 3-dimensional~     images of lung ventilation can be obtained in both pediatric and adult patients during a~     single short breath-hold following inhalation of the gas.~      This is a 2-part study to evaluate the effect of VX-770 on hyperpolarized helium-3 magnetic~     resonance imaging (3He-MRI), and to evaluate the safety and efficacy of VX-770 in subjects~     aged 12 years and older with CF who have the G551D-CFTR mutation. Part A is a single-blind,~     placebo-controlled study that includes 4 weeks of VX-770 treatment and 4 weeks of placebo~     treatment. Part B is an open-label, 48 week study of long-term effect of VX 770 on~     hyperpolarized 3He-MRI.~   "
183609|NCT01161524|"~     This study is designed to investigate the short- and long-term effects of perampanel on~     cognition, growth, and development in adolescents.~   "
183610|NCT01161511|"~     This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574.~     The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended~     dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK,~     PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients~     with relapsed or refractory CLL/SLL.~   "
183611|NCT01161498|"~     This study is being conducted to learn about the safety and risks of using talimogene~     laherparepvec to treat patients with head and neck cancer and to see if talimogene~     laherparepvec and chemoradiation together can destroy the tumours versus the use of~     chemoradiation alone. This study may provide information on the usefulness of talimogene~     laherparepvec combined with chemoradiation as a future treatment for head and neck cancer.~   "
183612|NCT01161485|"~     There is a need to identify and test effective strategies to reduce meth use and human~     immunodeficiency virus (HIV) risk behaviors in heterosexuals. This project will compare the~     efficacy of a manually-driven HIV testing and counseling (HIV T/C) intervention, with HIV T/C~     plus a manualized Contingency Management (CM), with HIV T/C plus CM plus a manualized~     Strengths-Based Case Management (CM/SBCM) model. As HIV T/C is the standard of care, the~     investigators are testing to determine if the investigators can enhance this standard. The~     specific aims and hypotheses of this protocol are:~        1. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing drug use,~          specifically meth use. Hypothesis 1: CM/SBCM will reduce drug use more than those in CM~          (which will have more reduction than HIV T/C), potentially mediated through increased~          service utilization.~        2. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing HIV and STI~          risk behaviors, specifically sex risk behaviors but also needle risk for injection drug~          users (IDUs). Hypothesis 2: CM/SBCM will have greater decreases in HIV risk behaviors~          than those in CM (which will have greater decreases than HIV T/C), potentially mediated~          through reduced drug use.~        3. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on improving mental~          health status. Hypothesis 3: CM/SBCM will have greater improvements in mental health~          status than those in CM (which will have greater improvements than HIV T/C), potentially~          mediated through increased service utilization and reduction of drug use, and~          potentially moderated by baseline meth use.~   "
183613|NCT01161472|"~     The study is designed to evaluate elements of cognitive function in subjects receiving either~     fesoterodine or alprazolam.~   "
183614|NCT01161459|"~     The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus~     steroid in the treatment of membranous nephropathy.~      To investigate the safety and tolerability of Tripterygium wilfordii plus steroid~   "
183615|NCT01161446|"~     The purpose of this study is to determine whether the availability of home self-testing for~     HIV will increase HIV testing frequency among men who have sex with men without negatively~     impacting their risk for HIV acquisition.~   "
183616|NCT01161433|"~     Spirometry is a recommended component of asthma diagnosis and treatment in the primary care~     setting, however, few primary care providers report routine use of spirometry in the~     provision of care for their asthma patients. Even when spirometry is used to aid in asthma~     severity classification, primary care providers have a high rate of failing to meet the~     quality goals for testing established by the American Thoracic Society.~      The goal of this study is to evaluate the effectiveness of a virtually delivered quality~     improvement (QI) program. The program is designed to train primary care providers and their~     medical staff in the use of spirometry to improve pediatric primary care management for~     children with asthma.~   "
183617|NCT01161420|"~     The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the~     Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat~     moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of~     the hypoglossal nerve. Study objectives include demonstrating that the Inspire system~     improves key indices of sleep apnea in a pre-specified percentage of patients.~   "
183618|NCT01161407|"~     The purpose of this study is to gain a better understanding of calcium absorption and~     metabolism in patients with Chronic Kidney Disease (CKD) using calcium balance and kinetic~     methods.~   "
183619|NCT01161394|"~     Pioglitazone decreases oxidative load, inflammatory end points and improves vascular~     reactivity in obese patients in a dose dependent manner and that this effect is independent~     of its glucose lowering effects.~   "
183637|NCT01161160|"~     This study is designed to characterize the safety and immunogenicity of pandemic influenza~     (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.~   "
183638|NCT01161147|"~     The objective of this study is to determine the relative bioavailability of one 15 mg~     Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam)~     Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fed conditions.~   "
183791|NCT01159132|"~     The purpose of this study is to study and compare the pharmacokinetics profile of low dose~     raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected~     patients.~   "
183620|NCT01161381|"~     Objective: Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a common sleep disorder~     requiring the time and money consuming full polysomnography to be diagnosed. Alternative~     methods for initial evaluation are sought. The investigators aim was the prediction of~     Apnea-Hypopnea Index (AHI) in patients suspected to suffer from OSAHS using two models based~     on nonlinear analysis of three biosignals during sleep.~      Methods: One hundred patients referred to a Sleep Unit underwent full polysomnography. Three~     nonlinear indices (Largest Lyapunov Exponent, Detrended Fluctuation Analysis and Approximate~     Entropy) were extracted from three biosignals (airflow from a nasal cannula, thoracic~     movement and Oxygen saturation) providing input to a data mining application for the creation~     of predictive models for AHI.~   "
183621|NCT01161368|"~     The objective of this phase II study is to gain first information on the efficacy (PFS, ORR~     and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive metastatic~     breast cancer pretreated with a combination therapy (chemotherapy and/or hormonal therapy)~     including lapatinib and presenting with tumor progression.~      Primary objective is to assess the efficacy with respect to the percentage of patients~     surviving without disease progression as assessed by RECIST criteria.~      Secondary objectives are to assess the efficacy of the study treatment with respect to the~     objective response rates as assessed by RECIST criteria version 1.1, the overall survival and~     to evaluate the safety profile of the combination by recording the adverse events and~     abnormal laboratory values associated with the study treatments.~      The main efficacy endpoints will be investigated both for the intent-to-treat (ITT)~     population and the per-protocol (PP) population.~   "
183622|NCT01161355|"~     The primary objective of this study is to assess the absolute bioavailability and to evaluate~     pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of~     [14C]AZD9668 in healthy male subjects.~   "
183623|NCT01161342|"~     The aim of the study is to estimate the prevalence of malnutrition among older adults~     admitted to hospital and to analyse predictive factors for malnutrition. Further, the aim was~     to analyse the association between nutritional status and all-cause and cause-specific~     mortality.~      The hypothesis is that malnourished patients have a higher mortality then well-nourished~     patients after three years.~   "
183624|NCT01161329|"~     Chronic conditions such as stroke are associated with physical disability and an economic~     burden for the family and the society. A medical approach is often not sufficient to address~     the bio-psychological process of chronic disease. Behavioural medicine approaches are often~     needed to improve the treatment outcomes. Those approaches have often successfully been used~     together with physical activity to change health behaviour in inactive individuals and in~     pain management. In this project the combined approach of behavioural medicine principles and~     physical training will be tried on patients who have had a stroke one year ago where it has~     yet only been used scarcely. As the study focus on the individuals' ability to function and~     be active the primary outcome measure is disability. The aim of the study are in a randomized~     controlled study evaluate if a high intense functional exercise program as an group~     intervention under three months can influence functional, psychosocial, anthropometric and~     biochemical factors 3, 6 months and 1 year after the start of the study. Following outcome~     variables will be analyzed:~        1. level of physical activity, motor function and balance~        2. depression and health-related quality of life~        3. body mass index (BMI), metabolic risk profile, inflammation status~        4. number of falls, fall-related self-efficacy and outcome expectations~   "
183625|NCT01161316|"~     The purpose of the study is to evaluate the efficacy and safety of the combination of~     mFOLFOX-6 plus cetuximab for 8 cycles followed by mFOLFOX-6 plus cetuximab or single agent~     (s/a) cetuximab as maintenance therapy in patients (pts) with metastatic colorectal cancer~     (mCRC).~   "
183626|NCT01161303|"~     We have developed in vitro systems including primary epithelial cell cultures and explant~     cultures of bronchial tissues to study the interaction between the bronchial mucosa and~     allergens. This approach involves culturing bronchial biopsies under optimal conditions and~     stimulate them with allergens thus enabling us to perform a dynamic study without the need of~     performing several bronchoscopies and will allow the testing of unapproved substances, which~     could, otherwise, not be delivered, in vivo.~      We wish to apply these ex vivo bronchial culture systems to assess cytokine release in~     moderately severe asthmatics and evaluate the effects of blocking TNF-alpha signalling using~     anti TNF-alpha monoclonal antibodies.~   "
183627|NCT01161290|"~     HYPOTHESIS:The study purpose is to evaluate the effectiveness of a structured pursed-lips~     breathing (PLB) protocol taught via real-time interactive telecommunication with a home~     computer using the lnternet and Skype software in veterans with chronic obstructive pulmonary~     disease (COPD. The primary hypothesis is veterans with COPD and dyspnea on exertion who~     receive a PLB educational intervention taught via weekly interactive telecommunication over a~     4-week period will have greater reduction of exertional dyspnea compared to those who receive~     the PLB educational intervention with no weekly interactive sessions.~      RESEARCH PLAN: An experimental two- group design is used. All subjects receive a brief 5 - 10~     minute one-on-one PLB educational session. Subjects are then randomized to either the~     intervention group or the control group. The intervention group receives 4 weekly interactive~     group sessions with the health educator (principal investigator)via computer. A free software~     program known as Skype allows synchronous video and audio interaction. The comparison group~     receives only the brief PLB educational session with no weekly follow-up.~      RESULTS: At end of 4 weeks, the intervention group had significantly lower dyspnea intensity~     scores (group X time interaction F = 6.69, p = 0.02) and significantly higher social support~     scores (group x time interaction F = 4.34, p = 0.058).~      CLINICAL SIGNIFICANCE: Skype is a viable means for providing patient education. A structured~     PLB protocol provides significant differences in exertional dyspnea over time. A structured~     PLB protocol plus Skype showed significant reduction in patients' sense of dyspnea intensity~     and increased social support scores.~   "
183628|NCT01161277|"~     The main objective is to investigate if the brain activation signature of a typical~     antipsychotic agent is dissociable from a newer drug with a pharmacological profile that~     differs from both typical and atypical antipsychotics since it is a potent partial D2~     agonist. The method used to study this will be functional magnetic resonance imaging (fMRI).~   "
183792|NCT01159119|"~     The purpose of this study is to evaluate two different treatments in subjects with chronic~     pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.~   "
183629|NCT01161264|"~     Influenza poses a significant threat to individual and public health, and influenza~     vaccination with a trivalent inactivated influenza vaccine is widely recommended to children,~     adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains~     used in interpandemic influenza vaccines are adjusted every year according to WHO (World~     Health Organization) and CHMP (Committee for Medicinal Products for Human Use)~     recommendations. Following a change in the vaccine antigen composition recommendation from~     the previous season, immunogenicity and tolerability of the newly composed vaccines are~     subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects~     according to the guidelines set by EMEA (CPMP/BWP/214/96).~   "
183630|NCT01161251|"~     Atrial fibrillation (AF) is the most common sustained dysrhythmia encountered in clinical~     practice in North America and Europe, accounting for approximately one-third of all~     hospitalizations for a cardiac rhythm abnormality. The presence of AF markedly increases the~     patient's risk for developing arterial embolism and stroke, depending on the presence of~     other clinical conditions, such as hypertension and diabetes. AF is associated with a~     fivefold increased risk for stroke, and is estimated to cause 15% of all strokes.~      Patients with AF frequently have several risk factors for atherosclerosis, including~     hypertension, diabetes, and dyslipidemia. Accordingly, systemic signs of atherosclerosis can~     be detected in AF patients, and these likely accounts for an enhanced risk of coronary heart~     disease. In addition to cerebrovascular disease, patients with AF may suffer from coronary~     events including myocardial infarction (MI), but the rate of MI in AF patients seems to be~     variable, but often underestimated.~      Moreover, coexistence of peripheral arterial disease (PAD) is a relevant clinical sign of~     systemic atherosclerosis.~      Ankle-brachial index (ABI) is a simple, inexpensive, and non-invasive PAD measurement, even~     at the pre-symptomatic phase when intervention can improve prognosis and prevent or delay~     severe complications ABI is calculated by measuring the systolic blood pressure in the~     posterior tibial and/or the dorsalis pedis arteries either in both legs or 1 leg chosen at~     random (using a Doppler probe or alternative pulse sensor), with the lowest ankle pressure~     then divided by the brachial systolic blood pressure. In addition to peripheral artery~     disease, the ABI also is an indicator of generalized atherosclerosis because lower levels~     have been associated with higher rates of concomitant coronary and cerebrovascular disease,~     and with the presence of cardiovascular risk factors.~      Two large studies in patients with AF document the existence of PAD in about 3-5% of~     patients. It is possible, however, that such an incidence has been underestimated as only~     symptomatic patients were considered as affected by PAD. As PAD is an important marker of~     systemic atherosclerosis, its association with AF reinforces the concept that patients with~     AF have systemic atherosclerosis that potentially account for coronary complications.~      To date, a national registry of AF patients is not available to verify the real impact of~     cardiovascular events in this clinical setting.~   "
183631|NCT01161238|"~     The goal of this project is a useful clinical instrument for diagnosis and treatment of~     residual limb volume fluctuation in individuals who use prosthetic limbs. One hypothesis to~     be tested is that the instrument effectively measures short and long term volume fluctuations~     in individuals with trans-tibial amputation. Another hypothesis to be tested is that when~     subjects add a sock or insert to the prosthesis residual limb volume decreases, and when they~     remove the sock or insert residual limb volume increases.~   "
183632|NCT01161225|"~     Aims of this study are:~        1. To determine the feasibility of implementing the intervention using a peer-assisted~          asthma day camp for adolescents with asthma.~        2. To determine patterns of change in knowledge, attitudes toward asthma, self-efficacy,~          perception of barriers, and self-management behaviors, asthma control and quality of~          life over time among peer leaders.~        3. To test the following hypothesis:~             -  Adolescents participating in a peer-assisted asthma camp program will report~               improved knowledge, attitudes toward asthma, self-efficacy, and self-management~               behaviors, decreased perception of barriers, and increased asthma control and~               quality of life at 3-, 6- and 9-months post-intervention compared with the~               adult-led camp group.~        4. To examine the moderating effect of personal factors (e.g., age, sex, socioeconomic~          status, race, illness status, family support) on intervention outcomes such as~          self-management behaviors, asthma control and quality of life in adolescents with~          asthma.~        5. To examine the effect of the peer-assisted camp program on self-reported health care~          utilization including emergency department visits, days of hospitalization, outpatient~          visits by comparing between baseline and 9-months post-camp data and between the~          peer-led camp and the adult-camp programs.~   "
183633|NCT01161212|"~     In French primary schools, children participate in 3 compulsory hours of physical education~     (PE) each week unless they have a medical contra-indication. But, there is no scientific~     evidence (randomized trial) that a weekly physical activity splitting up of these 3 hours of~     PE brings or not the same effects, particularly to prevent overweight or obesity.~      Regul'aps is a cluster randomized controlled trial which wants to evaluate whether splitting~     up the 3 hours into 3 or 4 sessions (vs. 1-2 sessions) of PE per week has an effect on speed~     of a BMI increase and on health-related quality of life (HRQoL) over the school year.~      Study hypothesis: reduction of speed of increase of BMI and an increase of HRQoL~   "
183634|NCT01161199|"~     Despite the dramatic improvements that have resulted from combination antiretroviral~     treatment, long-term efficacy, toxicity, cost, and the requirements for life-long adherence~     remain as formidable challenges. Also, there is emerging consensus that persistent~     HIV-associated disease occurs during long-term highly active antiretroviral therapy (HAART).~     This disease may be due to either direct drug-toxicity and/or persistent viral~     replication/production and/or persistent HIV-associated inflammation. Hence, strategies aimed~     at achieving complete viral eradication may be needed in order to fully restore health among~     HIV infected individuals. Even if complete eradication proves impossible—as most believe to~     be the case—a less rigorous but still desirable outcome might be achieving durable control of~     virus in the absence of therapy. That a functional cure is possible is well illustrated by~     those rare individuals who are able to durably control replication competent virus in the~     absence of therapy (elite controllers).~      A more complete understanding of the relationship between inflammation and viral persistence~     is necessary before more rationale studies of HIV eradication can be designed. Also, a well~     validated high through-put virologic assay needs to be developed that can estimate the size~     of the latent reservoir. Since the level of replication competent virus in long-term treated~     patients (and in elite controllers) is very small (< 1% of CD4 cells harbor HIV), large~     numbers of CD4+ T cells most be obtained from study participants in order to routinely~     isolate and quantify virus persistence.~   "
183635|NCT01161186|"~     The purpose of this study is to evaluate optimal dose and safety of the combination of~     Abraxane, gemcitabine, and Xeloda (capecitabine) (AGX) as first-line therapy in patients with~     metastatic pancreatic cancer.~   "
183639|NCT01161134|"~     The objective of this study is to determine the relative bioavailability of one 15 mg~     Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam)~     Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fasting conditions.~   "
183640|NCT01161121|"~     The purpose of this study is to determine if regadenoson is as safe and effective as~     adenosine when used in the cardiac catheterization lab during measurement of coronary flow~     reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional~     Flow Reserve (FFR) in the catheterization lab can be performed with equivalent accuracy when~     hyperemia is induced with IV Regadenoson compared with IV Adenosine without compromising~     patient safety.~   "
183641|NCT01161108|"~     The purpose of the study is to evaluate the safety and efficacy of oral melatonin in~     improving sleep continuity in children with epilepsy and neurodevelopmental delay who have~     chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release~     Melatonin (TR MLT) with placebo in a randomized cross-over design trial.~   "
183642|NCT01161095|"~     The primary objective of the investigators study is to determine if there is a difference in~     continuation rates at six months in women who are randomized to have the Levonorgestrel~     Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as~     after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks~     postpartum).~   "
183643|NCT01161082|"~     This study will test the safety, tolerability, and bioeffects (how the body reacts to the~     drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in~     hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will~     be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3~     study drug injections over 16 clinic visits, which will include 3 overnight stays(study~     duration 148 days, not including the screening period). Patients on atorvastatin will take~     their daily dose in the morning for the duration of the study. Patients will be monitored by~     the study staff for side effects and the body's response to the study drug. Vital signs(blood~     pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples~     will be collected at some or all visits.~   "
183644|NCT01161069|"~     The purpose this study is to evaluate the safety and toleration of PF-03049423 following~     multiple dose administration as an oral solution to healthy young adult volunteers and~     healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423~     after multiple dose administration to healthy young adult volunteers and healthy elderly~     volunteers. The study will also explore the relationship between blood pressure (supine and~     standing) and PF-03049423 concentration.~   "
183645|NCT01161056|"~     The purpose of this study is to enrol generally healthy adults, who are asked to provide a~     blood sample, to study how the immune system works.~   "
183646|NCT01161043|"~     The purpose of this study is to assess performance of a new subcutaneous glucose sensor over~     a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In~     addition performance of the new sensor will be calculated for use of the new sensor with~     proposed new devices using new calibration algorithms.~   "
183647|NCT01161030|"~     This trial examined the impact of acute and chronic almond ingestion on indicators of glucose~     control (postprandial glycemia and hemoglobin A1c). Hypotheses:~        1. Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D~          The investigators were not able to demonstrate a relationship between GLP-1 secretion~          and almond consumption. Individuals with T2D were characterized with significantly~          greater GLP-1 secretion than the non-diabetic control subjects.~        2. Acute ingestion of almonds will decrease the postprandial glycemia and insulinemic~          responses in healthy controls and in individuals with T2D The investigators data support~          the hypothesis: almond consumption by individuals with T2D did attenuate postprandial~          glycemia; however, almond consumption did not alter glycemia in non-diabetic control~          subjects~        3. Chronic almond ingestion for 12 weeks will reduce fasting glucose (FG) and A1c~          concentrations in individuals with T2D The investigators data demonstrated modest~          beneficial effect of almond consumption on A1c in individuals with T2D. Almond~          consumption was also associated with modest weight loss as compared to the control~          treatment (low fat cheese sticks).~   "
183648|NCT01161017|"~     Mechanism-based choice of therapy for pain:~      Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?~   "
183649|NCT01161004|"~     It has been demonstrated that antagonism of neuromuscular blockade (neostigmine 0.04 mg kg-1)~     affects depth of anaesthesia with an increase in bispectral index (mean maximal change of~     7.1) and middle-latency auditory evoked potentials (mean maximal change of 9.7).~      Sugammadex has a quicker and more complete effect than neostigmine. This study aims to~     demonstrate if sugammadex administration increases bispectral and neurosense indices of the~     depth of anesthesia while patients still receive propofol-remifentanil iv anesthesia.~   "
183650|NCT01160991|"~     Patients suffering from schizophrenia have a high risk to become obese and develop diabetes.~     Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine~     or olanzapine. These drugs are called atypical drugs and exert their action in part by~     occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may~     also interfere with glucose metabolism and insulin action. The purpose of this study is to~     compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A~     receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine~     pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of~     placebo on separate days. Then, a combined glucose clamp study will be performed in order to~     test the effects of these drugs on insulin sensitivity and insulin secretion.~   "
183651|NCT01160978|"~     The aim of the study is to investigate the effects of donor simvastatin treatment on~     ischemia-reperfusion injury after heart transplantation.~   "
183652|NCT01160965|"~     The aim of this trial is to compare the local anaesthetic ropivacaine to local anaesthetic~     levobupivacaine in converting the standard patient controlled labour epidural to provide~     anaesthesia for an emergency Caesarean section. This is a technique commonly known as an~     epidural top-up. The investigators set out to disprove the hypothesis that there is no~     difference between the 2 local anaesthetics in the time of onset and number of times epidural~     top-up needs supplementing during surgery.~   "
183664|NCT01160809|"~     The combined use of a mosquito repellent and long lasting insecticidal nets (LLINs) by~     household members would result in a 40% reduction in malaria prevalence compared with~     households that only use LLINs.~   "
183653|NCT01160952|"~     -  The primary objective of this study is to evaluate the efficacy and safety profile of~          itraconazole as in primary prophylaxis~        -  The second objective of this study is to find the difference between long-term versus~          short-term sequential therapy of Itraconazole (intravenous followed by oral~          itraconazole) as primary prophylaxis of invasive fungal infections (IFI) in patients~          undergoing allogeneic stem cell transplantation (allo-SCT)~        -  also to explore the relationship between the incidence of IFI with plasma concentrations~          of itraconazole and hydroxy-itraconazole~   "
183654|NCT01160939|"~     Objectives: To study the behavior and cardiovascular safety protocol to the front~     low-intensity exercise in patients with heart failure (HF) severe, awaiting heart~     transplantation. Methods: The investigators studied 21 patients with severe HF on the list~     for a heart transplant at the University Hospital of UNIFESP. After evaluation, patients~     underwent exercise protocol with six stages of exercise (1. upper limbs, 2. inferiors, 3.~     walk 35 m, 4. ½ flight of stairs, 5. walk 200 m 6. a flight of stairs) with intensity between~     2-6 metabolic equivalents. These also were followed for an average period of 17 months as the~     clinical complications and death. Results: From the patients studied, three were not able to~     perform the full protocol, and the variables body mass index, maximal inspiratory and~     expiratory pressure measurement (Pimáx and Pemáx, cmH2O) and number of previous admissions,~     showed the most divergent behavior of the sample studied. A greater increase in heart rate,~     double product and scale of perceived exertion during step 5 was observed during the~     protocol. Blood pressure levels showed little change between stages, and there was no~     arrhythmias incidence increase (kappa = 0.552) compared to effort. A positive correlation~     scale was perceived in exertion walking distance of 200m, with systolic blood pressure (r =~     0.4, p = 0.02). Overall observed lower values of maximal inspiratory pressure and increased~     blood pressure and elevated heart rate in patients with death outcome. Conclusion:~     Cardiovascular behavior against exercise protocol was well tolerated and safe, but suggests~     need for monitoring. Information collected at initial clinical evaluation associated with~     decompensation and death, and may help stratify these patients.~   "
183655|NCT01160926|"~     To determine the maximum tolerated dose (MTD) of AZD6244 or AZD2171 when combined with~     pre-operative capecitabine and radiotherapy in patients with locally advanced rectal cancer.~   "
183656|NCT01160913|"~     The purpose of this randomized double-blind study is to evaluate in which anatomical layer~     (AF versus BF) continuous wound infusion of local anesthetics combined with NSAIDs through a~     multiorifice catheter has the best effectiveness during the first 48 hours on postoperative~     pain intensity after elective cesarean delivery.~   "
183657|NCT01160900|"~     Few reports described outcomes of complete compared with infarct related artery (IRA) only~     revascularization in patients with ST elevation myocardial infarction (STEMI) and multivessel~     coronary disease (CAD).~      The purpose of this study is to determine outcome (death, myocardial infarction, target~     vessel failure) of 180 consecutive patients with STEMI and multivessel CAD undergoing primary~     angioplasty.~      Before the first angioplasty patients are randomized to 2 different strategies: 1) culprit~     vessel angioplasty only, 2) staged revascularization.~   "
183658|NCT01160887|"~     The purpose of this study is to investigate whether patients with diabetes-related peripheral~     neuropathic pain also have non-recognized damage to the intestine caused by autonomic~     neuropathy. The model will shed light on aspects of peripheral nerve injuries on both somatic~     and as well as visceral sensory nerves. Classical autonomic parameters from~     electrocardiography (ECG) and Holter (24-h ECG and blood pressure) are compared with~     peripheral nerve injuries. The damage of autonomic nerves often recognized late in the course~     when patients develop gastroparesis, however an earlier recognition of this nerve damage may~     help clarifying the fundamental pathomechanisms and thereby optimize treatment for this~     patient group in the future.~   "
183659|NCT01160874|"~     The Attention Deficit/ Hyperactivity Disorder (ADHD) is a developmental disorder which~     affects 3 to 5 % of school age children. This disorder persists in the adulthood for 60 % of~     subjects. Children with ADHD are sleepier during the day than normal children. However, there~     is no information concerning the diurnal sleepiness of adults with ADHD and the impact of~     this sleepiness on their driving capacity. The investigators postulate that the negative~     impact of ADHD is due to an awakening disorder which adds to the attentional disorder. The~     aim of this study is to estimate both the sleepiness by a Maintenance Wakefulness Test (MWT)~     and the capacity to drive in adults with ADHD.~   "
183660|NCT01160861|"~     This is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in~     patients with seasonal or perennial allergic rhinitis to investigate the safety,~     tolerability, and pharmacokinetics (PK) of MEMP1972A.~   "
183661|NCT01160848|"~     Open, prospective, randomized, single-centre study in patients with moderate to severe facial~     acne vulgaris. Three circular areas with a diameter of 4 cm, each circle including at least 4~     inflammatory lesions, will be selected in acne-affected areas in the face. One area should be~     identified on each cheek and one area should be identified on the forehead. The minimum~     distance between the three areas should be at least 4 cm. For each patient the three areas~     will be randomized to either a pre-treatment cleaning using a wipe containing an ethyl~     alcohol solution(one area) or a cleansing wipe containing saline water (two areas), before~     application of the Visonac cream. One of the areas cleaned with saline wipe will also be~     occluded with a transparent dressing (Tegaderm) during the incubation time. In vivo~     fluorescence spectroscopy will be performed in the three areas before cream application, and~     at 1h, 1.5h, 2h, 2.5h and 3 h after cream application. After the last fluorescence~     spectroscopy reading, the cream should be wiped off and the patient should protect the three~     areas from sunlight, prolonged, or intense light for 2 days.~      The study was extended with additionally 8 patients to explore the photoactive porphyrin~     levels over a 24 hour period:~      The patients will clean their face with Cetaphil Gentle Skin Cleanser before cream~     application. For each patient the three areas will be randomized to Visonac 80mg left on the~     skin for 24 hours and Visonac (MAL8%) to be wiped of after 1 hour.~      In vivo fluorescence spectroscopy will be performed at all three areas before cream~     application, and at 2h, 3 h, 4h, 5h, 8h, 10h, 11h, 12h, 13h, 15 and 24h after cream~     application. The exact time points may be adjusted based on the result from the previously~     included patients. All patients will be instructed to protect the three areas from sunlight,~     prolonged, or intense light for 2 days.~   "
183662|NCT01160835|"~     Quadriceps-sparing minimally invasive total knee arthroplasty (TKA) with side-cutting~     instruments has been proposed to limit surgical dissection without compromising the surgical~     outcome. We conducted a prospective, randomized study to compare the outcomes of~     quadriceps-sparing TKA with conventional medial parapatellar TKA, with two-year follow-up.~      We hypothesize that the quadriceps-sparing arthrotomy would not outperform the conventional~     medial parapatellar arthrotomy in TKA, in terms of postoperative recovery of quadriceps~     muscle strength, alignment of the prosthetic knee, and clinical outcome.~   "
183663|NCT01160822|"~     The purpose of this study was to determine whether, in patients with mild to moderate knee~     osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.~   "
183665|NCT01160796|"~     This is a national, multi-centre, randomized, double-blind placebo-controlled, phase III~     superiority trial.~      The main objective of the trial is to assess the efficacy of Lcr35® by comparing the mean~     time before the onset of the first clinical recurrence confirmed by laboratory tests in~     patients with bacterial vaginosis treated with Lcr35® versus placebo.~      Patients with bacterial vaginosis will be enroll by private gynecologists. Each patient will~     receive a treatment for the initial episode(Metronidazole)and a treatment to prevent the~     recurrence of bacterial vaginosis (Lcr35®).~   "
183666|NCT01160783|"~     This study is working towards gaining a better understanding of the genetic and environmental~     factors involved in autism spectrum disorders (ASD), which includes autism, pervasive~     developmental disorder (PDD), and Asperger's syndrome. The investigators hope that~     information gained from this study will lead to new ways of diagnosing and treating ASDs.~   "
183667|NCT01160770|"~     The objective of this study is to evaluate the long-term safety and effectiveness of~     open-label clobazam in the treatment of drop seizures in subjects with LGS.~   "
183668|NCT01160757|"~     The purpose of this study is to find out how effective and safe an experimental ultrasound~     device is for treating Acute Acne lesions.~   "
183669|NCT01160744|"~     The purpose of this study is to determine if participants with Stage IV NSCLC have a better~     outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or~     gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin~     or gemcitabine + carboplatin/cisplatin alone.~   "
183670|NCT01160731|"~     RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving panobinostat together~     with etoposide and cisplatin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when~     given together with etoposide and cisplatin as first-line therapy in treating patients with~     extensive-stage small cell lung cancer.~   "
183671|NCT01160718|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells.~     AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It is not yet known whether fulvestrant is more effective with or without AZD6244 in~     treating patients with advanced breast cancer.~      PURPOSE: This randomized phase II trial is studying how well fulvestrant works with or~     without AZD6244 in treating patients with advanced breast cancer that progressed after~     aromatase inhibitor therapy.~   "
183672|NCT01160705|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This clinical trial is studying blood samples in predicting how patients with~     prostate cancer will respond to treatment with docetaxel.~   "
183673|NCT01160692|"~     A Study to evaluate the cognitive effects and tolerance of a Multi-Vitamin/Mineral~     Preperation containing Gingko in elderly subjects with age associated memory impairment.~   "
183674|NCT01160679|"~     This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25~     hospitals in naturalistic treatment setting. There will be no experimental component~     associated with this study and all observational activities have to be part of routine care~     visit: baseline (week 0), week 4 and week 12.~   "
183675|NCT01160666|"~     Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF~     (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis~     of SS in both systemic and glandular features, and B cell downregulation may lead to a~     decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic~     lupus erythematosus, where Belimumab has been proven to be effective.~   "
183676|NCT01160653|"~     The purpose of this study is to test a unique, combined cognitive and motor intervention~     designed to restore safe, more normal coordinated gait components into the real world~     environment for individuals with stroke.~   "
183677|NCT01160640|"~     This study is a randomized placebo-controlled trial comparing two antibiotic treatment~     regimens for acute PID. Women with acute PID will be randomized to one of two treatment~     regimens: 1) a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally~     twice a day for 14 days, along with placebo tablets orally twice a day for 14 days or 2) same~     doses of ceftriaxone and doxycycline, and metronidazole 500 mg orally twice a day for 14~     days. The primary objective is to compare the eradication of anaerobic organisms from the~     upper genital tract between women who receive standard outpatient antibiotic treatment to~     those who receive standard outpatient treatment along with a two-week course of~     metronidazole.~   "
183678|NCT01160627|"~     OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients~     with ST segment elevation myocardial infarction treated with primary percutaneous coronary~     intervention.~      DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a~     rise in creatinine >25% from baseline Serum creatinine will be measured at baseline and each~     day for the following 3 days and at 30 days.~      Patients will be randomised to:~        1. Standard treatment~        2. Standard treatment + acetylcystein for 2 days~        3. Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours~        4. Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by~          100 ml/h for 5 hours~   "
183679|NCT01160614|"~     The purpose of this study is to characterize the pharmacokinetics (PK) of single-dose ORF~     tablets in pediatric patients aged 6 to 16 years, inclusive.~   "
183680|NCT01160601|"~     This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin~     with or without bavituximab in patients that have previously untreated locally advanced or~     metastatic non-small cell lung cancer (NSCLC).~   "
183681|NCT01160588|"~     This study will attempt to identify gene and brain activity markers that predict whether~     children and adolescents with anxiety disorders will respond to selective serotonin reuptake~     inhibitor medications or Cognitive Behavioral Therapy (CBT).~   "
183682|NCT01160575|"~     With an estimated 2.5 million HIV-infected persons, India is home to one of the largest~     populations of HIV-infected persons in the world. Yet, it is estimated that less than 20% of~     the people living with HIV in India are aware of their status. Andhra Pradesh (AP), situated~     in south India, is the state with the highest HIV burden in India. Reports from AP suggest~     usage of voluntary counseling and testing (VCT) is low, especially among high-risk groups.~     VCT has been shown to have many benefits in addition to diagnosis of HIV infection such as~     reduction in risk behavior, partner referral, and serving as an entry point to the health~     care system. Community mobilization and VCT vans have been shown in the past to play a role~     in increasing utilization of VCT services in various developing countries similar to India.~     The primary objective of this protocol is to arrive at an effect size of community~     mobilization alone, and both community mobilization and VCT vans, on the adoption of VCT~     services in Andhra Pradesh, India. Secondary objectives include identifying barriers to VCT,~     assessing stigma in the community, and establishing a specimen repository at the YRGCARE~     infectious disease laboratory in Chennai, India. We will achieve these objectives by~     conducting a cluster randomized clinical trial with 3 arms: ARM 1: standard of care with~     pre-existing VCT centers (SVCT); ARM 2: community mobilization in the setting of pre-existing~     VCT centers (CVCT); ARM 3: community mobilization plus VCT van in addition to the~     pre-existing VCT centers (MCVCT). The overall study duration will be 6 months from~     randomization. To our knowledge, this is the first study to examine the role of community~     mobilization and VCT vans on the adoption of VCT in the Indian context. It will provide us~     with vital data that will be used to plan a larger powered study to evaluate the~     effectiveness of these interventions including sites from other parts of India. Additionally,~     this study will also provide us with important information on barriers to VCT in these~     communities....~   "
183683|NCT01160562|"~     Plasmodium falciparum malaria remains a global public health threat. Leading malaria vaccine~     candidates confer only partial short-lived protection at best. An understanding of the~     mechanisms by which humans acquire malaria immunity through repeated P. falciparum infections~     may aid the development of a malaria vaccine. This pilor study is designed to initiate the~     epidemiological groundwork for a future prospective cohort study of acquired malaria immunity~     in Kalifabougou, Mali, a rural village of approximately 5 000 individuals who are exposed to~     seasonal P. falciparum transmission each year from July through December. This study will~     estimate the age-stratified point prevalence of P. falciparum infection before the malaria~     season and at the peak of the 6-month malaria season, and it will estimate the age-stratified~     incidence of symptomatic p. falciparum infection during the 6-month malaria season. The~     spatial distribution of asymptomatic P. falciparum infections and incident malaria cases~     within the village of Kalifabougou will be determined by merging the prevalence and incidence~     data with census and Global Positioning System (GPS) data.~   "
183684|NCT01160549|"~     International variation in breast cancer rates and data from migrant and animal studies~     support the possibility that exposures early in development, including the in utero period,~     play a role in breast carcinogenesis. One of the most striking prenatal influences on breast~     cancer risk is whether the woman was born in a country with a low or high breast cancer~     incidence. This observation has led to interest in the degree to which in utero exposures~     vary by the maternal environment, and to the hypothesis that alterations in prenatal~     concentrations of steroid hormones, particularly estrogens, and other biologic parameters to~     which the fetus is exposed mediate differences in subsequent breast cancer risk.~      There are striking differences in breast cancer incidence rates between Asian and North~     American and Western European populations, but variation within Asia is also wide. Incidence~     in Mongolia is one of the lowest in the world (6.6/100,000) while China, its neighbor to the~     south, has about three times this rate (18.7/100,000). Furthermore, rates appear higher in~     urban than in rural areas. Over the last decade and a half Mongolia has experienced profound~     economic changes resulting in mass migration from a nomadic or semi-nomadic existence to a~     more western lifestyle in the capital city of Ulaanbaatar. Together with the contrast in~     exposures between traditional and urban settings, migration presents the opportunity to study~     women as they acculturate to a more western lifestyle.~      We propose collecting maternal and cord blood samples from pregnant Mongolian women and their~     offspring living in rural and urban areas to describe concentrations of several steroid~     hormones and growth factors. The purpose of the study is to assess whether the in utero~     environment differs in women living a traditional lifestyle compared with a more urban~     lifestyle, and by degree of western acculturation among those who have recently migrated to~     the capital. Maternal and cord blood samples from an ongoing cohort study being conducted at~     the University of Pittsburgh will provide a comparison group of US women.~   "
183685|NCT01160536|"~     This study proposes to describe how children s hypertrophic cardiomyopathy (HCM) risk status~     affects family functioning, behaviors, and relationships. HCM is the most common inherited~     cardiovascular single-gene disorder. Individuals with HCM may experience shortness of breath,~     chest pain, palpitations, dizziness, syncope, heart failure, and arrhythmias predisposing to~     sudden cardiac death at any age. Notably, HCM is the most common cause of sudden cardiac~     death in people under 30 years of age. Genetic testing can identify at-risk individuals;~     however, the impact of potentially life-altering genetic information on families remains~     largely unexplored. Increasingly, health care providers are providing the testing in children~     for conditions like HCM that are life-threatening and medically manageable without the~     benefit of understanding the psychological consequences. The few studies that have been~     conducted suggest that genetic testing in children may result in changes to family~     relationships, parental emotional wellbeing, parenting behaviors, and child functioning in a~     subset of children. One synthesis of these studies suggests that children as a group show~     little evidence for maladjustment to risk information, but that parents are affected by the~     carrier status of their children. The proposed study intends to further this body of~     knowledge by exploring the impact of children s risk status on families with HCM. Health care~     providers and researchers can inform their work with HCM families by better understanding the~     potential impact of genetic risk as an important component of families adaptation to the~     life-threatening information about their children. The families targeted for this exploratory~     study will be purposively sampled from those that have been aware of the children s risk~     status or not at-risk status for HCM for at least 3 months. The cross-sectional design is~     composed of semi-structured interviews with a parent and, separately, with his/her 13 to 23~     year-old child who is either a carrier for HCM, a non-carrier, or at 50% risk for being a~     carrier. The interview will target issues related to the perceived impact of the child s risk~     status on family functioning, parenting behaviors and relationships. Data from the~     parent-child dyads will be analyzed for concordance/discordance along parallel themes. The~     results of this study may facilitate the understanding of the perceived impact of learning~     children s HCM risk status, which will inform both clinical care and future research.~     Importantly, since predictive testing in children for adult-onset diseases is generally~     discouraged, very little is actually known about its impact on families. Therefore, the study~     of this unique subgroup of an HCM population that uses clinically indicated predictive~     testing in childhood offers a preliminary opportunity to learn about predictive testing of~     minors.~   "
183686|NCT01160523|"~     Background: Podoconiosis is a debilitating condition affecting one million people in~     Ethiopia. Podoconiosis is preventable if those at genetically high risk consistently~     protected their feet from exposure to silica nanoparticles present in clay soil. Despite the~     efforts of a local Non-Government Organization (NGO) the Mossy Foot Prevention & Treatment~     Association (MFTPA) to distribute shoes to podoconiosis patients and their children, use of~     footwear is intermittent. This protocol proposes a collaboration among faculty from NHGRI,~     Addis Ababa University, and the MFTPA to develop and test intervention approaches that have~     the potential to be sustained by the community, to motivate children from families affected~     by podoconiosis to consistently wear shoes.~      Objective: The three primary aims are to: (1) use qualitative assessment strategies to~     explore factors influencing shoe use among high-risk children; (2) use these findings to~     develop culturally-tailored intervention modules; and (3) evaluate in a randomized trial the~     individual and joint effects of the intervention modules in encouraging high-risk children to~     consistently wear shoes.~      Population: Children (ages 9 -15) from families affected by podoconiosis who are~     participating in shoe distributions in one of 13 communities in the Wolaita zone of Ethiopia~     served by MFTPA.~      Methods: Guided by the PRECEDE-PROCEED approach to planning, implementing and evaluating~     public health programs, a two-phase study is proposed.~      Phase 1 will employ qualitative methods including participant observation, extended case~     studies, key-informant interviews and focus group discussions in a sample of 4 communities to~     gain understanding of the factors that influence shoe wear among high-risk children. Informed~     by these results, content for two modules (an enhanced education module and a role model~     support module) will be developed with the aim to motivate consistent use of footwear.~      Phase 2 will evaluate the individual and joint effectiveness of the two intervention modules~     in a randomized 2 x 2 factorial design with communities assigned randomly to one of 4~     intervention conditions: (GP1) no enhanced health education and no role model support (usual~     care), (GP2) enhanced health education without role model support, (GP3) no enhanced health~     education with role model support, and (GP4) enhanced health education and role model~     support. All children receive shoes. Children will be surveyed at baseline, 3-5 days after~     shoe distribution, and again, 3- and 6- months post baseline.~      Outcomes: The primary outcome is a composite of direct observation of shoe use, self-reported~     shoe use, and baseline-to-follow-up changes in the children s foot appearance based on a~     visual foot exam.~   "
183687|NCT01160510|"~     High mammographic density (HMD) is the strongest risk factor for non-familial breast cancer~     apart from age and gender. Studies of sisters and twins suggest that approximately 67% of the~     variation in density is attributable to common genetic factors. However, to date, efforts to~     identify genetic determinants of HMD have achieved limited success. We and others (Boyd et al~     Lancet Oncol 2009) postulate that this lack of progress in identifying genetic determinants~     of density is related to a failure to study younger women and misclassification of density.~     As women age, their breast tissues undergo atrophy, which is manifested radiologically as a~     decrease in mammographic density, resulting in a convergence of density values and a masking~     of inter-person variation. This protocol is intended to demonstrate the feasibility of~     methods that we plan to use in a full-scale analysis of mammographic density among women~     under age 50 years who receive care at the University of Vermont, Fletcher Allen Health Care~     (FAHC) and have been followed through the Vermont Breast Cancer Surveillance System (VBCSS).~      The Hormonal and Reproductive Epidemiology Branch (HREB) is currently conducting a~     cross-sectional study entitled, Breast Radiology Evaluation and Study of Tissues (BREAST)~     Stamp Project which aims to understand why mammographically dense tissues are related to~     elevated breast cancer risk. This project is being conducted within the VBCSS using breast~     cancer awareness Stamp Act funds. The BREAST Stamp project has focused on women between the~     ages of 40-65 years who were referred for radiologically-guided biopsy to evaluate an~     abnormality identified on a screening mammogram. The study has successfully enrolled over 400~     women with collection of questionnaires, buccal and blood samples, and tissues. The study~     will continue recruiting through May 2010, with a targeted enrollment of 450-500 women.~     Through the infrastructure developed for the BREAST Stamp Project, mammographic volumetric~     density data, assessed using a novel method with density phantoms developed at UCSF, has been~     collected on approximately 25,000 screened women of all ages from February 2008-present.~      The current protocol describes a study in which we propose to capitalize on infrastructure~     that has been established through the BREAST Stamp Project. We propose to perform this study~     in two phases: Phase one will be a feasibility study: specifically, we propose to demonstrate~     that we can use a mailing to collect Oragene tube format saliva collection kits as a source~     of germline DNA and a short self-administered questionnaire. This collection of specimens and~     data will be used to inform the launch of phase two, the full-scale study to identify~     determinants of mammographic volumetric density among approximately 10,000 women less than 50~     years of age for whom raw images and density data are already collected. During the first~     phase we hope to demonstrate feasibility by achieving at least 60% participation with~     unbiased representation of subjects with regard to demographics and volumetric density~     measurements. Once feasibility of this approach is established, we propose to launch the~     full-scale study by contacting the remaining (approximately 10,000) women with existing~     volumetric density data to collect questionnaires and DNA samples necessary to delineate the~     genetic determinants of mammographic density, as well as to investigate hypothesized risk~     factors for mammographic density and breast cancer risk, such as alcohol intake, cigarette~     smoking, and breastfeeding history.~   "
183688|NCT01160484|"~     This is a phase II, multicenter, open label, nonrandomized study to evaluate the efficacy and~     safety of lenalidomide at a dose of 10 mg/dose in combination with bortezomib at 1.0~     mg/m2/dose, pegylated liposomal doxorubicin (PLD) at 4.0 mg/m2/dose, and intravenous (IV)~     dexamethasone at 40 mg/dose in adult patients with relapsed/refractory multiple myeloma (MM).~     The study consists of a screening period, followed by up to eight 28 day open label treatment~     cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a~     follow-up period.~   "
183689|NCT01160471|"~     Background:~      - Heart failure is a common cardiovascular disorder whose incidence increases with age,~     affecting up to 10% of people older than 65 years of age. As the population ages, the~     prevalence and cost of heart failure will continue to rise. Researchers are interested in~     using noninvasive imaging methods to better understand the symptoms and effects of heart~     failure.~      Objectives:~      - To conduct a noninvasive comparative imaging study of individuals with heart failure.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with heart failure (with at~     least mild symptoms and slight limitations on physical activity).~      Design:~        -  This study will last approximately 2 years and will require four visits to the National~          Institutes of Health Clinical Center, with one screening visit and three study visits.~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine samples.~        -  Participants will have the following tests during each study visit:~        -  Physical examination~        -  Blood and urine samples~        -  Cardiac magnetic resonance imaging~        -  Cardiac computerized tomography to study the blood vessels in and leading to the heart~        -  Echocardiogram to evaluate heart function~        -  Electrocardiogram to measure heart electrical activity~        -  The three study visits will take place 1 year apart. Participants will also receive~          follow-up phone calls 6 months after the first and second visits.~        -  No treatment will be provided as part of this protocol.~   "
183690|NCT01160458|"~     Background:~      Background:~      - IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug~     Administration, is an antibody that is designed to block the effects of a protein called Type~     I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to~     IGF-1R, which are thought to play an important role in helping cancer cells to grow and~     divide. Researchers are interested in determining whether IMC-A12 is an effective treatment~     for individuals who have mesothelioma that has not responded to standard chemotherapy.~      Objectives:~      - To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with~     mesothelioma who have previously had chemotherapy.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not~     responded to chemotherapy.~      Design:~        -  Eligible participants will be screened with a full physical examination and medical~          history, blood and urine samples, and imaging studies.~        -  Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be~          evaluated before the start of each new cycle with blood tests and imaging studies if~          needed.~        -  Treatment cycles will continue for as long as needed, unless severe side effects develop~          or the disease progresses.~   "
183691|NCT01160445|"~     Background:~        -  Aldesleukin (IL-2) is a drug that can help to shrink tumors in some patients with~          metastatic renal cancer and metastatic melanoma. It is possible that removing certain~          white blood cells (known as CD4 cells) before IL-2 treatment may improve the treatment~          effects.~        -  Zanolimumab is an antibody that works by destroying CD4 cells in the blood. Researchers~          are interested in determining whether zanolimumab can improve the results of IL-2~          treatment if it is given before, during, and after IL-2 treatment. In addition, further~          research with zanolimumab may provide more information on how IL-2 treatment causes~          tumors to stop growing or shrink.~      Objectives:~      - To evaluate the effectiveness of IL-2 treatment in conjunction with zanolimumab in~     individuals with metastatic cancer.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma or~     metastatic kidney cancer.~      Design:~        -  Eligible participants will be screened with a full physical examination and medical~          history, imaging studies, and blood samples, including leukapheresis, to remove a sample~          of white blood cells for testing purposes. Participants may also have a colonoscopy and~          biopsies if they have received previous treatments that have been known to cause colon~          damage.~        -  Participants will be treated with zanolimumab and IL-2 treatment for 9 weeks.~        -  Zanolimumab will be given on an outpatient basis during weeks 1 through 4, 6, 8, and 9.~          In weeks 5 and 7, participants will receive zanolimumab as an inpatient in addition to~          IL-2 therapy.~        -  Inpatient IL-2 treatment will be given during weeks 5 and 7. Up to 15 doses of IL-2~          treatment will be given over a maximum of 5 days, followed by inpatient recovery time.~        -  During week 5, participants will have tumor imaging studies prior to receiving~          zanolimumab and IL-2 treatment.~        -  About 2 weeks after the treatment period, participants will return to the clinical~          center for a 2-day evaluation with a physical examination, imaging studies, and blood~          samples.~        -  Participants whose tumors have responded to treatment will be offered up to two~          additional courses of treatment, starting 6 to 8 weeks after the last IL-2 dose.~          Subsequent courses will be given exactly as described above in the initial course of~          treatment. Participants whose tumors do not respond to treatment will have follow-up~          evaluations as required by the study researchers.~   "
183692|NCT01160432|"~     The aim of the study is to examine the tolerability and abuse potential of the diluted~     methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution~     treatment.~      Study hypothesis: Treatment with this diluted combination product is safer than with~     methadone alone (5 mg/ml) and combination product does not precipitate withdrawal symptoms in~     opioid dependent patients.~   "
183693|NCT01160419|"~     The rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant~     treatment.~      This strategy is based upon the clear advantage of perioperative treatment and the fact, that~     in former trials adjuvant treatment could only be given in half of the patients (Cunningham~     2006, Boige 2007).~      In this study neoadjuvant chemotherapy is applied during a period of 12 weeks with an interim~     staging after 6 weeks.Due to the favourable efficacy and toxicity data the FLOT-regimen was~     chosen for the neoadjuvant treatment consisting of oxaliplatin, docetaxel, folinic acid and~     5-Fluorouracil (Al-Batran 2008).~      Postoperative treatment according to the results of the MAGIC trail is not part of the trail~     and is given at the responsibility of the participating centres.~   "
183702|NCT01160302|"~     There is considerable evidence that turmeric consumption may have a protective effect against~     cancer progression. The purpose of this study is to examine the short-term effects of~     supplementation with a turmeric extract, Curcumin C3 Complex®, on biomarkers of head and neck~     squamous cell carcinoma (HNSCC).~   "
183703|NCT01160289|"~     The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to~     tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED)~     who incompletely respond to tadalafil alone.~   "
183704|NCT01160276|"~     Ciclosporin inhibits P-glycoprotein should increase colchicine bioavailability whereas~     tacrolimus should not influence colchicine disposition.~      This is a prospective, controlled, open labeled study performed in renal graft recipients~     comparing colchicine single dose (1mg) pharmacokinetics in 14 patients treated with~     tacrolimus and 14 patients treated with cyclosporin.~   "
183694|NCT01160406|"~     The aim of the study is to assess the incidence of patients suffering from ischemic stroke or~     transient ischemic attacks who have underlying asymptomatic paroxysmal atrial fibrillation.~      Patients who have suffered an ischemic stroke or transient ischemic attack, without a history~     of atrial fibrillation, are planned to be included. Starting within 14 days of the ischemic~     stroke, participating patients are asked to perform 10 second ECG recordings using a handheld~     ECG device twice daily (mornings and evenings) during 30 days. These recordings are~     transmitted via telephone to a secure encrypted Internet site. Within these 30 days the~     participants also perform an ambulatory 24 hour Holter recording. Handheld ECG recordings are~     evaluated continuously. In case of atrial fibrillation the patient is informed and offered~     treatment with anti coagulant medication (Warfarin). The investigation is a comparison~     between 24 hour continuous ECG recordings and short intermittent ECG recordings twice daily~     over a longer time period to determine which method is the best to detect atrial fibrillation~     in this patient group.~      Hypothesis: Short Intermittent ECG recordings over a longer time period is more efficient,~     compared with continuous 24 hour ECG recordings, in detecting silent paroxysmal AF in~     patients with an ischemic stroke and without a history of atrial fibrillation.~   "
183695|NCT01160393|"~     Atrial fibrillation (AF) is the most common arrhythmia after cardiac surgery. The incidence~     of AF varies between 20 - 45 % after (coronary artery bypass grafting) CABG. It may lead to~     hemodynamic compromise, thromboembolic events, increased length of stay in the hospital and~     increased morbidity. The underlying cause of AF has been related to a variety of factors.~     Those most commonly related to the intraoperative management are the use of cardiopulmonary~     bypass (CPB), the influence of systemic inflammation, myocardial damage, intraoperative fluid~     management and the need of red blood cell transfusion.~      The purpose of the study is to find out the difference in the incidence of atrial~     fibrillation after CABG when using the conventional (CECC) or mini bypass system (MECC).~      The treatment protocol is similar in both groups except the CPB method (CECC vs. MECC). In~     both methods the investigators use MAQUET tubing and oxygenator. The investigators also~     collect special blood samples for determining most relevant factors found affecting in the~     incidence of AF.~   "
183696|NCT01160380|"~     The purpose of this study is to evaluate the efficacy of armodafinil for the treatment of~     cancer-related fatigue in adult patients with multiple myeloma. The study consists of a~     screening period, followed by a 56-day treatment phase, and a final assessment to occur 28~     days after the end of the last treatment.~   "
183697|NCT01160367|"~     Specific Aims and Hypotheses:~      Aim 1: To test the effect of the Trial of Ascertaining Individual preferences for Loved~     Ones' Role in End-of-life Decisions (TAILORED) Intervention on family decision-making~     self-efficacy at 8 weeks both with respect to the patient's present situation and in a~     hypothetical situation in which the patient lacks decision-making capacity.~      Hypotheses 1a: Family decision-making self-efficacy will be greater at 8 weeks in pairs that~     have undergone the TAILORED Intervention than in pairs receiving the standard information on~     advance directives in the patient's present situation.~      Hypotheses 1b: Family decision-making self-efficacy will be greater at 8 weeks in pairs that~     have undergone the TAILORED Intervention than in pairs receiving the standard information on~     advance directives in the hypothetical situation in which the patient lacks decision making~     capacity.~      Aim 2: To test the effect of the TAILORED Intervention on family psychological outcomes~     (depression, caregiver burden, decision making distress).~      Hypotheses 2a: Depression will be less at 8 weeks in family members who have undergone the~     TAILORED Intervention than in family members who have received the standard information on~     advance directives.~      Hypotheses 2b: Caregiver burden will be less at 8 weeks in family members who have undergone~     the TAILORED Intervention than in family members who have received the standard information~     on advance directives.~      Hypotheses 2c: Decision-making distress will be less at 8 weeks in family members who have~     undergone the TAILORED Intervention than in family members who have received the standard~     information on advance directives.~      Aim 3: To test the effect of the TAILORED Intervention on patient and family satisfaction~     with family decision-making involvement.~      Hypothesis 3a: Patient satisfaction with family decision involvement will be greater at 8~     weeks in patients who have undergone the TAILORED Intervention than in patients receiving the~     standard information on advance directives.~      Hypothesis 3b: Family member satisfaction with decision involvement will be greater at 8~     weeks in family members who have undergone the TAILORED Intervention than in family members~     receiving the standard information on advance directives.~      Aim 4: To explore family decision-making self-efficacy and perceptions of the TAILORED~     Intervention.~   "
183698|NCT01160354|"~     The goal of Part 1 of this clinical research study is to learn about the safety of the~     combination of plerixafor and clofarabine when given to patients with previously untreated~     AML who are at least 60 years old.~      The goal of Part 2 of this study is to learn if the combination of plerixafor and clofarabine~     can help to control previously untreated AML in patients who are at least 60 years old.~   "
183699|NCT01160341|"~     The study is designed to answer the following questions:~        1. Is hypogonadism a cause for the metabolic syndrome ?~        2. What is the effect of testosterone replacement on the metabolic parameters ?~   "
183700|NCT01160328|"~     The male sex hormone, testosterone, plays an important role in determining body fat~     distribution in men. This is especially evident in the dramatic shift in body composition as~     boys and girls reach sexual maturity. Normal weight women have twice the body fat of a normal~     weight man (30% vs. 15% on average) and men will have twice the stomach fat as women (10% vs.~     5% of fat as intra-abdominal, men vs. women). These are likely sex-steroid linked events.~     Short and long term changes in regional fat distribution accompany testosterone deficiency~     and can be reversed by testosterone replacement. Testosterone deficient men have increased~     stomach fat that can be reversed with testosterone replacement therapy. Interestingly, the~     mechanism by which testosterone affects where we store fat is unknown. It is important to~     understand how testosterone influences where we store fat as it is well established that~     increased stomach fat results in elevated disease risk.~      The proposed study aims to examine the effect of short term, temporary testosterone decreases~     on how and where men store fat. The investigators will compare fat storage between men given~     Lupron to temporarily decrease testosterone levels those that receive Lupron plus~     testosterone replacement vs. a no treatment control group. Comparing these three groups will~     allow us to understand the effects of testosterone on short-term changes in fat tissue~     function that lead to the long-term changes in where we store body fat.~   "
183701|NCT01160315|"~     Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to~     treat neoplastic and benign diseases. These drugs are definitely associated with premature~     ovarian failure (POF), resulting in an important decrease of the long-term quality of life~     and an increase of morbidity. A recent study showed that the patients treated by alkylating~     agents had a 4.52 fold higher risk to lose their ovarian function compared with those who~     were treated by other agents. The rate of POF after treatment ranged from 40 to 80%,~     according to the age of the patients and the total doses administered.~      Young women who experience POF have to face with the prospects of infertility and to consider~     years of hormonal replacement therapy. The possibility of minimizing gonadal damage by~     administering of protective therapy during chemotherapy represents an attractive option for~     these patients.~      The aim of this study is to evaluate the protective effect on the ovarian function of the~     gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating~     agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data~     in human are, however, highly controversial.~   "
183761|NCT01159522|"~     The goal of this study with SCB01A is to determine the Maximum Tolerated Dose of SCB01A in~     patients with advanced solid tumors that have failed previous therapy.~   "
183705|NCT01160263|"~     The purpose of this study is to study the transporters of serotonin and dopamine in ALS~     patients in relation with the clinical phenotype, i.e., patients without stiffness, patients~     with pyramidal stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness.~      For such a goal the investigators will use SPECT to compare the binding of two specific~     tracers in ALS patients and in matched healthy controls.~   "
183706|NCT01160250|"~     This is an open-label, non-comparative, multicenter, expanded access study of Vismodegib~     (GDC-0449) in patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC~     (mBCC) who are otherwise without satisfactory treatment options.~   "
183707|NCT01160237|"~     The aim of this study is to evaluate the immune response and the safety of one injection of~     FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single~     Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with~     any H1N1 pandemic vaccine will be enrolled as control.~      This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The~     impacted section is entry criteria.~   "
183708|NCT01160224|"~     GW766994 is a selective, competitive antagonist of the human CC chemokine receptor-3 (CCR3).~     It is proposed that the inhibition of the CCR3 receptor may provide a treatment for airway~     inflammation such as in asthma. This will be a double-blind, placebo controlled, parallel~     group study being conducted to evaluate the effects of GW766994 in subjects with~     mild-moderate asthma who have high sputum eosinophilia. The primary objective is to compare~     the effects of GW766994 to placebo on sputum eosinophils.~   "
183709|NCT01160211|"~     A study to compare the safety and efficacy of an aromatase inhibitor in combination with~     lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+~     metastatic breast cancer (MBC).~   "
183710|NCT01160198|"~     Iron deficiency anaemia (Haemoglobin, Hb < 12gm/dl) is one of India's major public health~     problems particularly in women. Effective control of iron deficiency anaemia decreases the~     incidence of fatigue, bodyache, headache, lack of concentration and menstrual complications.~     Iron bisglycine chelate has been used successfully to treat iron deficiency anaemia and is~     also a well tolerated therapy. Use of ferrous bisglycinate chelate one tablet daily as a~     nutritional supplement is well established in India. For treatment of iron deficiency~     anaemia, some women may need 1 tablet/day, while some may need 2 tablets/day. In India,~     ferrous ascorbate, 1 tablet daily is a widely accepted form of treatment for iron deficiency~     anaemia. The primary purpose of this study is to demonstrate the efficacy and tolerability~     profile of ferrous bisglycinate chelate to support the registration of this product as a~     'drug' in India. Comparative data between ferrous bisglycinate chelate and ferrous ascorbate~     will also augment our existing knowledge, which will further support appropriate use of~     ferrous bisglycinate chelate for the treatment of iron deficiency anaemia. Study design and~     patient population: This will be a multicentre, randomized, laboratory-blinded, parallel-~     group study. It is projected that the study will randomize 270 women (90 subjects in each~     treatment arm) with iron deficiency anaemia (Hb 6-9 gm/dl + serum Ferritin <15 μg/l) to~     either ferrous bisglycinate chelate 1 or 2 tablets/day, or ferrous ascorbate 1 tablet/day for~     8 weeks. At fortnightly visits, blood will be collected for Hb (to evaluate efficacy),~     adverse events will be documented (to evaluate tolerability), the investigational drugs will~     be dispensed and reasons for non compliance will be recorded. Study endpoints: The primary~     endpoint is defined as the rise of Hb from baseline after 8 weeks of treatment in each~     ferrous bisglycinate chelate group (1 tablet/day and 2 tablets/day). The secondary endpoints~     include the difference in the average change in Hb, difference in the rate of rise of Hb,~     difference in the proportion of patients who achieve a target Hb ≥12gm/dl and difference in~     the % incidence of gastrointestinal side effects during 8 week therapy with 2 dosing regimens~     of ferrous bisglycinate chelate (1 tablet/day and 2 tablets/day) and ferrous ascorbate 1~     tablet/day.~   "
183711|NCT01160185|"~     This meta-analysis was conducted to investigate the efficacy of Topotecan and other~     treatments for recurrent and stage IVB carcinoma of the cervix~   "
183712|NCT01160172|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of~     several formulations of an investigational Staphylococcal vaccine.~   "
183713|NCT01160159|"~     Rationale: To analyse the arterial state of women with thrombophilia by techniques studying~     micro and arterial macrocirculation because of a reported and still discussed increase risk~     in cardio-vascular events in these women.~      Primary objective: To measure endothelium dependent vasodilatation (VDE) in controls and in~     women with thrombophilia.~   "
183714|NCT01160146|"~     Overweight and obesity has become an epidemic which warrants more aggressive treatment.~     However, few primary care physicians (PCPs) address this issue or do not possess adequate~     education regarding treatment modalities such as nutrition counseling or bariatric surgery.~     The primary goal of this study will be to determine whether the referrals for weight~     management can be influenced through obesity education.~   "
183715|NCT01160133|"~     This is a multi-site, randomized, investigator-masked study to evaluate the physical effects~     of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a~     6-week, perspective, randomized, active-controlled, investigator-masked, parallel group~     study.~   "
183716|NCT01160120|"~     The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and~     efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of~     tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.~   "
183717|NCT01160107|"~     This study will determine whether the association of Revlimid and Prednisone (RP) as~     induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation~     treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM~     patients.~   "
183718|NCT01160094|"~     It will be conducted as an international multicenter prospective observational cohort study~     in a population of ErbB2 positive metastatic breast cancer patients, whose disease has~     progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1:~     patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression~     (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or~     more lines of treatment after 1st trastuzumab progression (third line or greater).~   "
183719|NCT01160081|"~     The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV),~     Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella~     pertussis (BP)infections in Mexico.~   "
183720|NCT01160068|"~     To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr.~     Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg~     tablets (Bristol-Myers Squibb, USA) in 48 + (2 standby) healthy, adult, human subjects under~     fed conditions.~      To monitor adverse events and to ensure the safety of subjects.~   "
183721|NCT01160055|"~     The purpose of this epidemiological study is to identify and characterize the bacteria~     causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.~   "
183793|NCT01159106|"~     The aim of the current study is to compare the application neurally adjusted ventilatory~     assist (NAVA) to optimize pressure support ventilation in 12 pediatric patients.~   "
183722|NCT01160042|"~     The objectives of this study are:~      To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr.~     Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg~     tablets (Bristol-Myers Squibb, USA) in 52 + (2 standby) healthy, adult, human subjects under~     fasting conditions.~      To monitor adverse events and to ensure the safety of subjects.~   "
183723|NCT01160029|"~     The objective of this study is to compare the rate and extent of absorption of nateglinide~     120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under~     fed conditions.~   "
183724|NCT01160003|"~     This study is a randomised, double-blind, placebo-controlled, dose ascending, 3-way crossover~     study in healthy adult male volunteers. The primary objective of the study is to assess the~     pharmacokinetics of 14 days dosing of GW870086X administered via nebules formulation. The~     secondary objective is to assess the safety and tolerability of repeat doses of nebulised~     GW870086X.~   "
183725|NCT01159990|"~     HIV vaccines are designed to create an immune response to certain components of the HIV virus~     called peptides. Previous research indicates that one peptide, called Gag, may be~     particularly important for stimulating an immune response to HIV. Many vaccines being studied~     combine multiple peptides, but including other peptides may weaken the body's response to~     Gag. This study will test whether a vaccine that targets Gag and another peptide called Env~     is better than a vaccine without Env at causing an immune response to Gag.~   "
183726|NCT01159977|"~     The study purpose is to evaluate the effect of a small group discussion based intervention on~     physician well-being, job satisfaction, and professionalism. Participants will be put in one~     of 3 groups by chance (as in the flip of a coin). A computerized selection process will be~     used to assign participants to the study groups. There is a 1 in 3 chance of being assigned~     at random to either of the 3 groups.~      The first study group will meet once every two weeks for 9 months (from September 2010~     through June 2011) from 12:30 pm until 2:00 pm. These meetings will be small group discussion~     sessions with groups of no more than 15 participants. Lunch will be provided for the first 30~     minutes, and group discussion during the next 1 hour will be guided by the session~     facilitator around such topics as work-life balance, meaning in work, medical mistakes,~     spirituality, and unmet patient needs. However, the discussions will be open forums, and the~     groups themselves will help decide on topics relevant to the group. The 1 hour of protected~     non-clinical time every other week required for this group will be funded by the study.~      The second study group will also have 1 hour of protected non-clinical time provided every~     other week for the same 9 months. This study group will not participate in small group~     discussions, but may use the protected time for professional tasks as they wish.~      Participants in the third study group will continue with their current work practices, but~     will be provided with protected time to complete study surveys. If group sizes are too small~     after recruitment to allow a complete study of all three groups, the third study group will~     be removed and participants will be randomly assigned to one of the first two study groups~     only.~      Participants in all groups will be asked to complete a quarterly survey on well-being, job~     satisfaction, and professionalism. Follow-up surveys will also be administered 3 months and 1~     year after the conclusion of the small group sessions. Each survey is expected to take~     approximately 20-30 minutes to complete.~   "
183727|NCT01159964|"~     The purpose of this clinical study is to assess the safety and immunogenicity of the~     immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC)~     patients, after tumor removal by surgery.~   "
183728|NCT01159951|"~     The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes~     (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of~     the same outcome after introduction of Havrix™ in Panama.~   "
183729|NCT01159938|"~     This Study is looking at whether high blood glucose levels after a meal affect arterial~     stiffness more or less than low blood glucose levels, and whether certain cardiovascular~     markers influence the outcome of this.~   "
183730|NCT01159925|"~     The purpose of this study is to collect epidemiological and clinical data to assess the~     vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals~     after the introduction of Havrix™ into the Expanded Program of Immunization.~   "
183731|NCT01159912|"~     A randomised, double-blind, double-dummy, placebo controlled (with rescue medication),~     multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation~     powder in the treatment of persistent asthma in adults and adolescents.~   "
183732|NCT01159899|"~     The purpose of this pilot study is to investigate the efficacy and safety of autologous~     transplantation, under arthroscopy, of Bone Marrow Mesenchymal stem cells, using, with a cell~     separator, a fresh non-culture expanded Autologous Bone Marrow derived Mesenchymal Stem,~     mixed and activated with proteins scaffold in patient with Knee cartilage defects and~     osteoarthritis. Based on extensive preclinical investigations, the technology of using~     freshly isolated bone marrow mononuclear cells mixed with proteins seems safe and most~     effective for a one-step correction of cartilage defect and restoration of the osteochondral~     complex, because the same mixture can generate cartilage in the vasculature-free knee joint,~     and bone in the environment of bone defects.~   "
183733|NCT01159886|"~     During colonoscopy, the colonoscopist employs various maneuvers, including changing the~     patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic~     examination. Posture change has also been reported to increase the success rate of ileal~     intubation. However, there has been no randomized trial which has shown that a particular~     posture of the patient increases the success rate of ileoscopy. The present study will be~     carried out to determine the impact of the patient's posture (left lateral vs supine~     position) on success rate of ileal intubation.~   "
183734|NCT01159873|"~     Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in~     Healthy Postmenopausal Women.~   "
183735|NCT01159860|"~     Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear~     during adult life. Patients with seborrheic keratoses frequently desire treatment due to~     symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be~     easily removed and have been treated in a number of different ways. Two of the simplest and~     most successful ways to remove seborrheic keratoses are cryosurgery and curettage.~      The investigators are conducting this study to see which of these two treatments has the best~     result.~      Approximately 24-30 people will take part in this research study at the Hershey Medical~     Center.~   "
183736|NCT01159847|"~     The aim of this study is to investigate the protective effects of sitagliptin on β cell~     function in patients with adult-onset latent autoimmune diabetes (LADA) and its mechanisms.~   "
183762|NCT01159509|"~     The loss of sodium during infancy causes long term changes in sodium intake. Human research~     shows that the loss of maternal sodium during pregnancy and neonatal after birth causes an~     increase sodium intake during childhood. A study that examined sodium intake among infants~     that were treated with diuretics during the post-natal period found changes in sodium intake~     compared to controls. In this study we will test sodium intake in young children who have~     suffered from vomiting due to Hypertrophic Pyloric stenosis during early infancy.~   "
183737|NCT01159834|"~     PROJECT JUSTIFICATION: Cervical cancer is a serious public health problem in Brazil, and is~     the cause of significant morbidity and mortality among Brazilian women. In spite of~     government efforts to improve the coverage rates of Pap tests, the disease-related incidence~     and mortality rates remain high and the diagnosis is still too late.Considering that the~     chronic human papillomavirus (HPV) related genital infection leads to cervical cancer~     development, cervical cancer should be the target of primary prevention through vaccination.~      PROJECT OBJECTIVES: This project aims to evaluate de following vaccination indicators: 1)~     Program acceptance rate; 2) Vaccine coverage rate; 3) Three-dose completion rate; 4) Rescue~     vaccination demand; 5) Adverse event rate;~      TARGET POPULATION: Schoolgirls attending the 6th and 7th grades of elementary school (mean~     age = 11.9 yo).~      VACCINATION PROGRAM: The program adopted the quadrivalent vaccine because it is considered~     superior to the bivalent vaccine in preventing HPV-induced lesions. In addition to preventing~     the development of pre-cancer lesions and cervical cancer, the quadrivalent vaccine has also~     proved to be effective in preventing condyloma, and vaginal and vulvar cancer. The girls~     received the vaccines doses at their schools (school-based program) and also at the Barretos~     Cancer Hospital.~      RESULTS:~      Program acceptance rate = 91.8% (95%CI: 87.0%-96.8%);~      Vaccine coverage for 1st, 2nd and 3rd doses = 87.5% (95%CI: 82.9%-92.2%), 86.3% (95%CI:~     81.8%-91.1%) and 85.0% (95%CI: 80.5%-89.7%).~      Three dose completion rate = 97.2% (95%CI: 92.0%-100.0%). Reasons for dropping out of the~     vaccination program included: moving out of town (17), lost during follow up (16), guardians'~     decision but without a reasonable justification (3), girl refused to continue in the program~     (1) and pregnancy (2). Two girls interrupted the vaccination because of adverse events~     reported by the parents.~      Rescue vaccination demand = 279 girls on the first dose (20.3%; 95%CI: 17.9%-22.8%), 357 on~     the second dose (26.3%; 95%CI=23.6%-29.1%) and 291 on the third dose (21.7%;~     95%CI=19.3%-24.4%).~      Thirty adverse events were recorded or observed in 4,074 doses, providing an adverse event~     rate of 0.7% (95%CI: 0.5%-1.1%). There was no severe adverse event.~   "
183738|NCT01159821|"~     The purpose of this study is to determine the concentration of 31001074 in blood samples from~     healthy volunteers who have been administered 31001074 and paroxetine.~   "
183739|NCT01159808|"~     The purpose of this study is to test the safety of different dose strengths of INX-08189 in~     healthy adults. The study will also look at how rapidly the drug breaks down in the body~     (pharmacokinetics or PK). The study objectives include:~        -  To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects~        -  To characterize the pharmacokinetic (PK) profile of single ascending oral doses of~          INX-08189 in healthy subjects~        -  To assess the food effect on the PK of a single oral dose of INX-08189~   "
183740|NCT01159795|"~     This study aims to establish whether impaired innate immune responses are associated with~     severity of Respiratory syncytial virus (RSV) infection.~   "
183741|NCT01159782|"~     We, the investigators, hypothesise that there are distinct gene profiles in~     rhinovirus-induced acute exacerbations of asthma. We further hypothesise that these changes~     in gene expression involve both known mediators of the asthma phenotype as well as other~     molecules not previously associated with asthma.~      The primary objective of this study is to use gene array analysis to determine differentially~     expressed genes in bronchial epithelial cells and alveolar macrophages from normal and~     asthmatic subjects before and during rhinovirus infection in vivo. A secondary objective is~     to determine whether any altered expressions are related to symptom severity, virus load,~     lung function or airway inflammation in vivo.~      We plan to recruit 45 subjects: 15 healthy volunteers, 15 asthmatics naïve to inhaled~     corticosteroid therapy, and 15 asthmatics on inhaled corticosteroids who will undergo two~     bronchoscopies, one prior to infection with rhinovirus and the second 4 days post~     inoculation. Bronchial brushings, biopsies and bronchoalveolar lavage (BAL) will be~     performed. RNA will be extracted with TRIzol reagent (Invitrogen, Carlsbad, CA) and purified~     by passage through RNeasy columns (Qiagen, Valencia, CA). Exon 1.0ST array chips (Affymetrix,~     Santa Clara, CA) will be used to analyse changes in gene expression. These are the most~     powerful genome expression tools available with 1.4 million probe sets and over 5.5 million~     features per array. Genes found to be significantly upregulated will be confirmed by~     quantitative RT-PCR.~      Using a novel method of collecting undiluted bronchial epithelial lining fluid~     (bronchosorption) large numbers of proteins will be measured with a MesoScale Discovery~     multiplexed array system (MesoScale Discovery, Gaithersburg, Md) allowing further~     confirmation of the gene array results as well as providing in vivo evidence of dysregulated~     protein production in asthmatics. Gene expression and protein levels will be correlated with~     viral load, symptom scores, lung function and airway inflammation in vivo.~      This study represents the first comprehensive evaluation of changes in bronchial epithelial~     gene expression during rhinovirus infection in vivo and therefore has the potential to~     provide significant insights into the host response in asthma and identify potential novel~     targets for further evaluation.~   "
183742|NCT01159769|"~     The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once~     daily in patients previously treated with twice-daily, topical, ocular, anti-allergy~     medications.~   "
183743|NCT01159756|"~     This study is a multi-site, unmasked phase IV study. Travacom(R) is a combination topical~     ocular agent, containing travoprost and timolol, which lower intraocular pressure (IOP) by~     complementary mechanisms of action. The safety and efficacy of both travoprost and timolol~     have been established as single and adjunctive therapy in well-controlled clinical studies in~     thousands of patients diagnosed with open angle glaucoma (OAG) or ocular hypertension. The~     objective of this study is to assess the safety and efficacy of changing to Travacom from~     prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular~     hypertension across India.~   "
183744|NCT01159743|"~     The purpose of this study is to compare the body fat distribution in Human Immunodeficiency~     Virus-1 (HIV-1) infected patients receiving, since the beginning and for at least two years,~     an antiretroviral therapy based on efavirenz or lopinavir/ritonavir and a combination of~     tenofovir plus emtricitabine (or lamivudine).~   "
183745|NCT01159730|"~     The purpose of this study is to assess the safety and tolerability of multiple doses of~     VB-201 administered for 4 weeks and its efficacy on biomarkers.~   "
183746|NCT01159717|"~     Retrospective comparison of complex cystic renal lesions which are found with computed~     tomography (CT) and were controlled with contrast enhanced ultrasound (CEUS).~   "
183747|NCT01159704|"~     Using a randomized clinical trial (RCT), this study is designed to assess the effectiveness~     of HIV (human immunodeficiency virus) risk-reduction interventions targeting injection drug~     users (IDUs) in three Ukraine oblasts (regions). The investigators propose to compare the~     effectiveness of a revised and updated manually-driven HIV testing and counseling~     intervention, the Counseling and Education (C & E) model developed by NIDA, with the C & E~     plus a manualized network intervention. At each site, Odessa, Donetsk and Nikolayev, 250~     index members and 500 of their network members will be recruited through street outreach~     over a 32-month period and randomly assigned to C & E alone or C & E plus the network~     intervention. Participants will be tested for drug metabolites, interviewed using ACASI~     (Audio Computer-Assisted Self-Interviewing), and given a rapid test for HIV at baseline, 6~     and 12-months. At six-months, network members will be asked to recruit two others they inject~     with but who are not in the study. Primary outcomes include knowledge, self-efficacy,~     injection and sex-related risk behavior reduction and partner disclosure among indexes and~     primary and secondary network members and intervention diffusion to secondary network~     members. The investigators hypothesize more positive and significant change, including~     injection and sex risk reduction, intervention diffusion, and partner disclosure, among~     indexes as well as first and second network members in the network plus C & E arm compared to~     C & E alone. Specific aims include:~        1. To compare the effectiveness of the C & E alone with the additive effect of a network~          intervention plus C & E in increasing knowledge about HIV and increasing self-efficacy~          to practice safer injection and sex-related behaviors among indexes, primary and~          secondary network members.~        2. To assess the effectiveness of the C & E alone with the additive effect of a network~          intervention plus C & E in reducing drug and sex risk behaviors among indexes, primary~          and secondary network members.~        3. To compare the extent of intervention diffusion to second wave network members in the~          two arms.~        4. To evaluate the extent of disclosure by HIV positive indexes and network members in the~          two arms~   "
183863|NCT01158157|"~     The purpose of this study is to vaccinate plasma donors with ACAM2000(TM) smallpox vaccine~     for collection of plasma to be used in the manufacture of Vaccinia Immune Globulin~     Intravenous (VIGIV).~   "
183748|NCT01159691|"~     The study intends to collect data on gastrointestinal symptoms (swallowing disorders,~     heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient~     satisfaction under everyday practice conditions after changing treatment to Neupro®~     transdermal patch in patients suffering from idiopathic Parkinson´s Disease with~     gastrointestinal symptoms while being treated with oral antiparkinson drugs. The objective of~     the study is to ascertain whether switching therapy to Neupro® transdermal patch can provide~     any relief in gastrointestinal symptoms.~   "
183749|NCT01159678|"~     The purpose of this study is to test an online psychoeducational intervention for men and~     women with sexual difficulties after surgery for colorectal (men and women) or gynecological~     (women only) cancer. A psychoeducational intervention is a brief, educational treatment that~     encourages participants to also pay attention to, and modify, their thoughts, feelings, and~     behaviour.~   "
183750|NCT01159665|"~     To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when~     administered at different time-points prior to planned primary pars plana vitrectomy (PPV)~   "
183751|NCT01159652|"~     The purpose of this study is to determine the effect of two hypnotic medications, zolpidem~     extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug~     duration will allow greater memory consolidation than a hypnotic with longer drug duration.~   "
183752|NCT01159639|"~     Reactive platelet hyperactivity following coronary artery bypass grafting (CABG) might lead~     to thrombotic complications and major ischemic cardiac events. The aim of this study is to~     evaluate the changes in platelet reactivity following CABG and to clarify a potentially~     beneficial effect of dual antiplatelet therapy in the group of patients with documented~     aspirin resistance following CABG. Platelet function will be assessed by multiple electrode~     aggregometry. Aortocoronary vein graft disease is comprised of three distinct but~     interrelated pathological processes: thrombosis, intimal hyperplasia and atherosclerosis.~     Early vein thrombosis is a major cause of vein graft attrition during the first month after~     CABG.~      Bypass patency can be improved with antiplatelet therapy which is the mainstay of treatment~     for patients after CABG. A beneficial effect of acetylsalicylic acid (ASA) on vein graft~     patency has been previously shown. Some patients experience thrombotic events despite~     continuous aspirin administration after CABG. The investigators hypothesized that low~     responsiveness to aspirin might be a precipitating factor for adverse thrombotic events~     following CABG.~      Low responsiveness to ASA, as assessed by platelet function tests, varies widely among~     patients. The etiology of postoperative platelet hyperactivity remains to be elucidated.~      In this study a new point-of-care assay named multiple electrode aggregometry (MEA) using a~     device called Multiplate analyzer (Dynabyte, Munich, Germany) has been utilized. It allows~     for rapid and standardized assessment of platelet function parameters.~      This is a prospective randomized trial. The aim of the study is to document whether~     introduction of dual antiplatelet therapy in patients with ASA resistance will lead to a~     lower incidence of major adverse cardiac events (MACE) at a six month follow up. The~     composite endpoint will include death, non-fatal myocardial infarction, stroke and cardiac~     rehospitalization. All patients will receive 300 mg of ASA starting 6 hours after surgery,~     provided that the chest tube output is minimal. On postoperative day 4 their platelet~     function will be assessed using the above mentioned MEA. The patients found to be aspirin~     resistant will then undergo the process of randomization. The first arm will include patients~     with ASA resistance in whom no additional antiaggregation will be administered. In the second~     arm the investigators will include patients who were randomized to receive 75 mg of~     clopidogrel in addition to the standard antiplatelet regimen of 300 mg of ASA.~      Platelet function monitoring allows for individual tailoring of the antiplatelet therapy. The~     goal of this study is to define whether this strategy will lead to improved patient outcomes.~     Both major and minor bleeding complications will be strictly monitored and reported.~   "
183753|NCT01159626|"~     This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to~     evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of~     PF-03463275 oral controlled release formulation in Japanese and Western male subjects.~   "
183754|NCT01159613|"~     The working hypothesis is that the low HDL serum level predict favorable response to anti~     viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve~     the rate of sustained virologic response.~   "
183755|NCT01159600|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin~     or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient~     glycaemic control.~   "
183756|NCT01159587|"~     The project is a controlled observational, multicenter, prospective data collection on~     secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A~     (FVIII < 1%).~      The observational period will cover at least 5 years per patient.~      The long-term secondary prophylaxis group will be compared versus on-demand treatment group~     by the assessment of orthopedic status progression and pharmacoeconomics evaluation.~   "
183757|NCT01159574|"~     This study is intended to investigate the combination of the combination of dexamethasone~     (Decadron®), Clarithromycin (Biaxin®), and pomalidomide (CC-4047®) [ClaPd] in multiple~     myeloma patients who have relapsed or refractory disease who have failed prior treatment with~     lenalidomide when used alone or in combination with corticosteroids. Primary endpoint will be~     response rate to treatment. Secondary endpoints will include toxicity of the combination,~     time to maximum response, and time to disease progression~   "
183758|NCT01159561|"~     This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number~     3-1-92.~   "
183759|NCT01159548|"~     There has been an increase in ambulatory surgical procedures performed across Canada;~     ambulatory procedures account for almost 70% of all surgeries. Postoperative nausea and~     vomiting (PONV) and pain are the most frequently reported adverse events by patients prior to~     discharge after ambulatory surgery. The incidence can be as high as 70 to 80% in high-risk~     patients.~      PONV is a cause of morbidity particularly in gynecological procedures and the incidence of~     patients experiencing PONV is as high as 58-75%. Apart from delayed recovery, the occurrence~     of PONV has been linked to gastric aspiration, psychological distress and wound dehiscence.~     The occurrence of PONV delays patient discharge and further more is a leading cause of~     unexpected admission after ambulatory anesthesia~      Promethazine, is an antiemetic medication that has been widely used over the last 50 years,~     and although effective at reducing PONV, it tends to cause sedation. In this study, we are~     trying to determine if a smaller dose of promethazine, in addition to the standard treatment~     for post-surgical nausea and vomiting, will be more beneficial than the standard treatment on~     its own.~      It is hypothesized that the use of low dose promethazine (3 mg) as part of a multimodal~     antiemetic regimen will be efficacious in preventing PONV without the sedative effects of~     promethazine.~   "
183760|NCT01159535|"~     The broad, long-term objective of the proposed randomized clinical trial is to evaluate the~     efficacy, moderators and mechanisms of change of two cognitive-behavioral aftercare~     treatments for alcohol and other drug (AOD) use disorders in preventing AOD relapse compared~     to treatment as usual (TAU) offered in the community. The two cognitive-behavioral aftercare~     treatments are relapse prevention (RP) and Mindfulness-Based Relapse Prevention (MBRP), which~     integrates mindfulness meditation and RP aftercare components.~   "
183763|NCT01159496|"~     This is a multiple ascending dose study to assess the safety, tolerability and~     pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to~     healthy young adults and healthy elderly subjects. The study will be conducted under~     double-blind conditions (neither the investigator nor the subject will know if he/she has~     received PF-05212377 or a placebo). The Sponsor will know if the subject has received active~     treatment or a placebo.~   "
183764|NCT01159483|"~     PF-04958242 in single doses will be safe and well tolerated by healthy volunteers.~   "
183765|NCT01159470|"~     Fever is one of the most common problems in pediatrics. Differentiating between bacterial~     infections, that require antibiotic therapy, and viral infections that resolve on their own~     is an important challenge for physicians.~      C-reactive protein (CRP) is a protein that increases in response to inflammation and its~     level is generally higher in bacterial infections compared to viral infections. it can be~     measured by a simple blood test, however its utility as a sole marker for bacterial infection~     is limited.~      The hypothesis of the study is that measuring CRP velocity, e.g the value of CRP divided by~     the hours since the fever started will improve the utility of CRP for the diagnosis of~     bacterial infections in children.~   "
183766|NCT01159457|"~     Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and~     carry a high morbidity rate. It has been recently shown that patients with celiac disease~     very often fail to develop immunity after standard vaccination for HBV during infancy. In~     this study, we will evaluate whether a second vaccination series with a different vaccine,~     Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients~     will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac~     vaccines.. Rate of responders and level of immunity will be compared. This study will~     facilitate better protection of celiac patients to this potentially deadly virus.~   "
183767|NCT01159444|"~     Home bi-level positive pressure ventilators are equipped with built-in softwares which~     measure and record specific items such as tidal volume, total ventilation, leaks, respiratory~     rate, cycles triggered by the patient. These items have not to date been described in a large~     group of patients under home mechanical ventilation.~   "
183768|NCT01159431|"~     This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS).~     TNS involves external electrical stimulation of sensory nerve located above the eyes and over~     the forehead. The purpose of this study is to determine if TNS is safe and effective using a~     rigorous randomized active-control clinical trial design in 50 people with epilepsy.~   "
183769|NCT01159418|"~     The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of Panobinostat~     (LBH589) when administered in combination with Carboplatin and Paclitaxel in patients with~     advanced solid malignancies and to identify the Recommended Dose (RD) for a subsequent Phase~     II study.~   "
183770|NCT01159405|"~     The purpose of this study is to evaluate the biodistribution and dosimetry of single dose of~     99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in~     patients with breast cancer at pre-chemotherapy.~   "
183771|NCT01159392|"~     Development of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in~     patients with severe brain injury has been associated with poor outcome. The application of~     lung recruitment maneuvers (RM) for a short period of time to open collapsed alveoli and~     reverse hypoxemia in early ARDS has been recommended. However, little is known about the~     cerebral and vascular effects of RM in brain injury patients with ALI/ARDS. The aim of this~     study is to assess the effects of a single standardized RM on oxygenation and on systemic and~     cerebral hemodynamics in severe brain injury patients with ALI/ARDS.~   "
183772|NCT01159379|"~     The purpose of this study is to assess cross-reactivity and tolerability of ertapenem in~     patients with IgE-mediated allergy to at least one beta-lactam molecule.~   "
183773|NCT01159366|"~     It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an~     infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography~     frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary~     collaterals may have beneficial effects in patients with OCA.~   "
183774|NCT01159353|"~     Primary Objective:~        -  To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion~          during the first hour after a standard meal in comparison to insulin aspart in obese~          subjects with type 2 diabetes.~      Secondary Objectives:~      Pharmacodynamic objectives:~        -  To assess the effect of insulin glulisine on the postprandial plasma glucose excursion~          during 6 hours after a standard meal in comparison to insulin aspart.~      Pharmacokinetic objective:~        -  To assess post-prandial plasma insulin excursion after a standard meal, in each~          treatment groups~      Safety objective:~        -  To assess the safety of insulin glulisine in comparison to insulin aspart~   "
183775|NCT01159340|"~     The clinical performance of Icare ONE Tonometer TA02 was compared to a Goldmann type~     applanation tonometer (Haag-Streit). Data was collected according to ANSI Z80.10-2003 (ISO~     8612.2) standard. Subjects were eligible for the study if they had no exclusion criteria~     specified in the ANSI/ISO standard. One eye from 260 subjects was selected for the study. The~     minimum sample size according to the standard is 150. One eye of each subject was selected~     for the study by an investigator, based on the history of the patient, results of an external~     examination of the eye with slit lamp, keratometry readings, and prior knowledge of the~     intraocular pressure (IOP) range. The Icare ONE Tonometer TA02 in comparison to the reference~     tonometer (Goldmann type tonometer).~   "
183776|NCT01159327|"~     A Phase I trial of weekly topotecan in combination with sorafenib in treatment of relapsed~     Small cell lung cancer (SCLC) has been commenced. In the present randomized phase 2 study,~     the investigators will research whether Sorafenib maintenance prolongs progression free~     survival (PFS) and overall survival (OS) in patients with ED-SCLC who achieved CR or PR after~     platinum-based induction chemotherapy.~   "
183788|NCT01159171|"~     This study will assess the efficacy and safety of treatment with the combination Avastin~     (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14~     of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally~     advanced or metastatic colorectal cancer. The anticipated time on study treatment is until~     disease progression.~   "
183789|NCT01159158|"~     The objective of this study is to compare the rate and extent of absorption of nateglinide~     120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under~     fasting conditions.~   "
183777|NCT01159314|"~     This research is being done to compare the safety and effectiveness of two sizes of the~     Baerveldt glaucoma implant.~      A Baerveldt glaucoma implant is one of the most common types of glaucoma operations~     performed. This procedure works by providing a route by which fluid can drain out of the eye~     to decrease the intraocular pressure. The Baerveldt implant does this by placing a tube into~     the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white~     portion of the eye). It is this plate that comes in two different sizes (250 square~     millimeters and 350 square millimeters).~      Earlier studies have shown that larger plate sizes produce lower eye pressures but that they~     may also result in more complications. While both Baerveldt devices are currently in use and~     have been shown to be safe and effective, it is unclear if one is superior to the other. The~     purpose of this study is to see if one size of device works better with fewer complications.~   "
183778|NCT01159301|"~     This phase I trial is studying the side effects and the best dose of entinostat when given~     together with sorafenib tosylate in treating patients with advanced or metastatic solid~     tumors or refractory or relapsed acute myeloid leukemia. Entinostat and sorafenib tosylate~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
183779|NCT01159288|"~     Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases~     per year, lung cancer is the 4th in terms of incidence but remains the leading cause of~     cancer death. The 5-year survival of lung cancer, all stages and all types, is very low,~     estimated at 12% among men and 16% among women in France. In advanced unresectable non small~     cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The~     median progression-free survival (PFS) in patients responding or stabilized after 4~     chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have~     developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by~     vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits~     Treg functions restoring T and NK cell effector functions and Dex are able to activate the~     innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex~     vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated~     a new process for isolation of second generation Dex with improved immune stimulatory~     capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients~     responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS~     rate at 4 months in these patients.~   "
183780|NCT01159275|"~     The purpose of this study is to study the pharmacokinetics profiles of generic~     lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability~     and efficacy.~   "
183781|NCT01159262|"~     The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of~     dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks~     gestational age, administered as a loading dose followed by a continuous infusion for a~     minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac~     intensive care unit (CICU), or pediatric intensive care unit (PICU).~   "
183782|NCT01159249|"~     This study is designed to demonstrate the long-term safety of vildagliptin in patients with~     type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin,~     thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the~     treatment of type 2 diabetes in Japan.~   "
183783|NCT01159236|"~     The goal of this clinical research study is to learn if using gene signatures can be an~     effective way to decide the best treatment for breast cancer patients. Gene signatures may be~     able to help researchers predict who will respond to chemotherapy given before surgery.~   "
183784|NCT01159223|"~     This study will compare the efficacy and safety of ATV/r at either 200/100 mg or 300/100mg~     given daily in Thai patients in combination with 2NRTIs.~   "
183785|NCT01159210|"~     The purpose of the study is to assess the efficacy and safety of Prothromplex Total as a~     treatment for the immediate reversal of oral anticoagulant therapy with vitamin K antagonists~     in patients with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX,~     X). Upon enrolment, subjects will receive Prothromplex Total for the treatment of acute~     bleeding due to oral anticoagulants or for the prevention of excessive bleeding during the~     interventional procedure (Day 1). Additional doses of Prothromplex Total may be administered~     at the discretion of the investigator. Efficacy and safety assessments will be performed~     during a period of 72 (± 4) hours after administration of the last dose of Prothromplex Total~     or until discharge from hospital, whichever occurs first.~   "
183786|NCT01159197|"~     Background~      More than 50% of dialysis patients experience sleep disturbances that significantly affect~     quality of life, overall morbidity, and mortality. There is no effective therapy except~     hypnotics, which have notable side effects. Cognitive-behavioral therapy (CBT) is effective~     for treating peritoneal dialysis (PD) patients, the elderly and cancer patients with chronic~     insomnia, but its effectiveness has never been reported in hemodialysis (HD) patients and its~     impacts on the inflammatory cytokines, oxidative stress and autonomic dysfunction in this~     population are unknown. The investigators investigated the effectiveness of CBT in HD~     patients by assessing changes in sleep quality, inflammatory cytokines, oxidative stress and~     autonomic dysfunction.~      Objects~      This study is designed to assess the effectiveness of CBT on sleep disturbance in insomnias~     HD patients. The investigators also evaluate the impacts of CBT on the inflammatory~     cytokines, oxidative stress and autonomic dysfunction in these insomnias HD patients.~      Methods~      The investigators expected to recruit 80 insomnias HD patients undergoing maintenance HD for~     more than 3 months for the investigation. Besides, 40 HD patients without sleep disturbance~     will be recruited for comparison. Patients with sleep disturbance (N=80) was randomized to~     either intervention (CBT) group (N=40) or control group (N=40). Participants in CBT group~     will receive 6-week CBT while in control group and patients without sleep disturbance only~     receive sleep hygiene education. The subjects were assessed at baseline and after the~     intervention with the Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS),~     Beck depression index (BDI) and the International Index of Erectile Function (IIEF) for men~     and the Index of Female Sexual Function (IFSF) for women; and inflammatory cytokines (serum~     IL-1β, IL-18, and TNF-α levels), oxidative stress (TBARS, Total antioxidant status and serum~     8-OHdG) and autonomic dysfunction (Baroreflex sensitivity, BRS) were measured.~      Expected results~      The investigators expect that CBT can improve the sleep disturbance in HD patients and may~     change the inflammatory cytokines, oxidative stress and autonomic dysfunction after the~     intervention in insomnias HD patients.~   "
183787|NCT01159184|"~     The increasing prevalence of diabetes brought great burden to health status of the~     investigators population. It is meaningful to investigate the stressor, stress perceived,~     social support and coping methods in diabetic population in order to provide appropriate~     assistance to these patients. This study will recruit diabetes patients from~     out-patient-department and they are invited to complete a questionnaire. The contents of the~     questionnaire including stress experienced, stress perceived, social support and coping~     methods. The investigators purpose is to find out the impact of these factors on glycemic~     controlled and their life quality. The results will be useful to diabetes care team when~     health education is delivered to patient.~   "
183794|NCT01159093|"~     This study will test the effectiveness of clinician-focused health IT-based decision support,~     family-focused health IT-based decision support, and a combination of both efforts, in~     increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that~     a combination of clinician-focused clinical decision support and family-focused decision~     support will be most effective.~   "
183795|NCT01159080|"~     To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with~     mycophenolate sodium dose increment will preserve renal allograft function without rising~     adverse effects~      Primary endpoints:~        1. estimated GFR (MDRD equation) 12 months after randomization~        2. estimated GFR change from randomization to end of the study (calculated by MDRD equation~          and Nankivell equation)~   "
183796|NCT01159067|"~     RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have~     undergone hematopoietic stem cell transplant and have iron overload.~      PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in~     hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose~     deferasirox on labile plasma iron is also examined.~   "
183797|NCT01159054|"~     Patients with kidney failure on hemodialysis have an extremely high rate of cardiovascular~     disease including atherosclerotic cardiovascular disease. This, at least in part, is due to~     the chronic inflammatory status usually seen in these patients. Here we try to see if~     treatment with extended release nicotinic acid (Niaspan) can reduce their overall~     inflammatory burden (in general) and the atherosclerotic plaque inflammation (in particular).~   "
183798|NCT01159041|"~     This study is designed to compare two treatments for depression in pre-adolescent (7-13 year~     old) children. A family-focused treatment will be compared to an individual child-focused~     treatment in this 14-week intervention.~   "
183799|NCT01159028|"~     The first goal of this clinical research study is to find the highest safe dose of BP1001, a~     liposomal Growth Factor Receptor Bound Protein-2 antisense oligodeoxynucleotide (L-Grb2 AS),~     for patients with Philadelphia Chromosome positive CML, AML, ALL and MDS. The response of the~     leukemia to this treatment will also be studied. The second goal of this clinical research~     study is to evaluate the safety and toxicity of the combination of BP1001 and concurrent~     low-dose ara-C (LDAC) in patients with AML.~   "
183800|NCT01159015|"~     This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in~     healthy adult subjects and in pediatric subjects with a history or family history of ocular~     allergy.~   "
183801|NCT01159002|"~     The purpose of this study is to evaluate the clinical usefulness of a capsule (SmartPill~)~     measuring pH, pressure and temperature from within the entire GI tract to determine gastric~     emptying time, combined small and large bowel transit time and total transit time. In~     addition, the Capsule will characterize pressure patterns and provide motility indices for~     the antrum and duodenum. It is believed that the condition of your digestive system can have~     a large impact on your overall physical health. Therefore,the investigators would like to~     assess whether using the pill device helps to determine any functional problems in patients~     in the ICU. The investigators are studying ICU patients because any change in their condition~     can have a large impact on their recovery.~   "
183802|NCT01158989|"~     The purpose of this study is to evaluate the clinical usefulness of a video camera pill~     (PillCam) in assessing intestinal function in the small intestines of patients. It is~     believed that the condition of the subjects digestive system can have a large impact on their~     overall physical health. Therefore, the investigators would like to assess whether using the~     pill device helps to determine any functional problems in patients in the ICU. The~     investigators are studying ICU patients because any change in their condition can have a~     large impact on their recovery. The same device will be used in healthy subjects scheduled~     for elective ambulatory surgery.~   "
183803|NCT01158976|"~     This will be the first study of the effect of essential fatty acid supplementation in~     pregnant women living in inner-city poverty on the stress response system during pregnancy.~     The investigators proposed that essential fatty acid supplementation will be associated with~     reductions in the experience of stress, more modulated hormonal response to stress, and more~     optimal regulation of emotion and attention in the infant, even within the context inner-city~     poverty.~   "
183804|NCT01158950|"~     In this study, we seek to understand the effects of tolcapone and entacapone, FDA-approved~     COMT inhibitors, on reward choice and response inhibition, two measures we have previously~     shown to be altered in subjects with alcoholism. We now plan to test the hypothesis that COMT~     regulation of cortical dopamine levels is critical for regulation financial choices.~     Specifically, we propose that the lower levels of cortical dopamine present in individuals~     with the val158val COMT genotype reduces the inhibitory effect of frontal cortical areas on~     impulsive choice; an idea that extends previous hypotheses about the negative consequences of~     decreased prefrontal dopamine levels on inhibitory control. Moreover, this hypothesis~     suggests that inhibiting COMT may slow the degradation of dopamine and thereby decrease~     impulsivity.~   "
183805|NCT01158937|"~     Meropenem is an intravenous antibiotic commonly used to treat acute exacerbation of~     respiratory infections in cystic fibrosis. The research study aims to determine if a~     different method of infusing the drug over 3 hours or longer, instead of the traditional~     half-hour will improve target attainment of drug concentrations and bactericidal activity. A~     secondary aim is to assess if the pharmacokinetics of meropenem is different during active~     infection compared to non-infective stage. Twelve patients admitted with acute respiratory~     infection and who requires meropenem will be enrolled into the study. Meropenem blood~     concentrations collected over 8 hours will be measured after half-hour and 3-hour infusions~     on different days. A pharmacokinetic modelling and Monte Carlo simulation program will use~     the data to assess and predict the optimal method of dosing. When patients return for a~     follow-up clinic visit, a single dose of meropenem will be administered and blood~     concentrations will be measured to determine the pharmacokinetics during non-infective stage.~   "
183806|NCT01158924|"~     Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5~     in subjects with early lumbar disc degeneration.~   "
183948|NCT01157039|"~     The investigators hypothesize that glutamine significantly reduces the incidence and severity~     of peripheral neuropathy in patients receiving oxaliplatin for metastatic colorectal cancer,~     decreases the need for dose reduction of oxaliplatin, and it does not impair oxaliplatin~     efficacy or pharmacokinetics.~   "
183807|NCT01158911|"~     Patients in the earlier stages of Chronic kidney disease (CKD) are at risk both for the~     development of end-stage renal disease (ESRD) (define by the requirement for dialysis or~     kidney transplantation) and development of cardiovascular disease (CVD). Although~     controversial, there is literature to suggest that uric acid may play a role in the~     progression of kidney disease and development of cardiovascular disease (CVD). The~     Modification of Diet in Renal Disease (MDRD) Study was a randomized controlled trial in~     patients with CKD, which examined the effects of dietary protein restriction and strict blood~     pressure control on progression of non-diabetic CKD. Extensive data on risk factors for~     progression of kidney disease and development of CVD are available, as is long term follow~     up. 838 of the 840 patients who were randomized have uric acid levels measured at baseline.~     The aims of the present study are to examine the determinants of uric acid in cross sectional~     analysis at baseline, to determine the association between uric acid and development of ESRD,~     and the association of uric acid with all-cause and CVD mortality.~      Level of kidney function will be a major determinant of uric acid levels independent of other~     risk factors.~      Level of uric acid will be associated with development of ESRD independent of level of kidney~     function and other risk factors.~      Uric Acid levels will be associated with both all-cause and CVD mortality independent of~     kidney function and other risk factors.~   "
183808|NCT01158898|"~     This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the~     efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days~     for the treatment of allergic asthma and allergen-induced asthma.~   "
183809|NCT01158885|"~     This study will test the ability of clofarabine + cytarabine to eliminate minimal residual~     disease (MRD) in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL)~     patients whose bone marrows exhibit complete remission by morphology. The toxicity profile of~     this regimen will be evaluated in addition to toxicity experienced by patients who proceed to~     stem cell transplant. Overall length of remission will also be collected.~   "
183810|NCT01158859|"~     The primary issue is to determine whether preoperatively administered pregabalin decreases~     the necessary dose of propofol during induction of general anesthesia. The investigators~     secondary issue is to test if preoperatively administered pregabalin decreases anxiety.~   "
183811|NCT01158846|"~     In the setting of ST elevation myocardial infarction newer therapies has been recently~     studied and, following encouraging results, introduced into the clinical practice. Prasugrel~     showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a~     better ischemic protection. On the other hand, bivalirudin is at least as beneficial as~     heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The~     primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be~     associated with a better risk/benefit profile.~   "
183812|NCT01158833|"~     In recent years Ferrari et al. proposed a new classification of gait in diplegic children~     with spastic diplegia that describes four different patterns of gait by analyzing the~     strategies that each children adopts to need his/her needs to walk. The investigators believe~     that this classification provides the clinician with clinically meaningful information in~     terms of coping strategies adopted to maximize the ability to walk.~      The aim of this study is to determine the criterion validity of the new classification of the~     pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait~     with the score of the Functional performance measure.~   "
183813|NCT01158820|"~     This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the~     use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in~     less respiratory depression while providing better compliance with the procedure.~   "
183814|NCT01158807|"~     This study is one of the three projects of an NIH Rare Disease Clinical Research Consortium.~     A consortium is a group of centres sharing information and resources to perform research.~     The consortium research focuses on brain blood vessel malformations in three different rare~     diseases.~      The focus of this specific study is on Hemorrhagic Telangiectasia (HHT).~      HHT is a condition characterized by blood vessel malformations, called telangiectasia and~     arteriovenous malformations (AVMs), occurring in the brain, nose, lungs, stomach, bowels and~     liver. Brain AVMs (BAVMs) in HHT are difficult to study because they are rare, affecting~     approximately 10% of people with HHT. While other types of BAVMs have been studied in depth,~     studies in the HHT population have been very small. Here, we propose the first large-scale~     collaboration by joining with 12 HHT Centers of Excellence in North America to perform a~     large study of risk factors for bleeding from BAVMs, called intracranial hemorrhage (ICH) in~     HHT patients.~      The current standard of clinical practice across North America, is to screen all HHT patients~     for BAVMs with magnetic resonance imaging (MRI). If BAVMs are detected, patients are referred~     to a multidisciplinary neurovascular team for consideration for treatment. Treatment~     decisions are made on a case by case basis, balancing risks of complications from the BAVM~     with risks of therapy, but are limited by the few studies available in HHT. We hope that the~     knowledge we obtain about the risk factors for intracranial bleeding in these patients from~     this larger study will help us to improve the care of HHT patients.~      We plan to study risk factors for rupture of BAVMs, including primarily genetics and imaging~     characteristics of the BAVMs. Knowledge about risk factors will help in the care and~     management of HHT patients. This will be achieved through the collection of health~     information to construct a HHT database, blood sampling and banking (through the National~     Institute of Neurological Disorders and Stroke [NINDS]), and through genetic analysis at the~     University of California San Francisco.~   "
183815|NCT01158794|"~     Iron overload, which can be defined operationally as too much iron in the body, develops as a~     consequence of too many blood transfusions given, or due to genetic defects hereditary~     hemochromatosis). Iron accumulates in several organs in the body, such as the heart, liver,~     endocrine glands (pancreas, thyroid, etc.), and spleen. Excessive iron can damage organs and~     may even cause death. Iron overload needs to be appropriately monitored and treated to avoid~     unnecessary morbidity and mortality.~      The present study, GENIOS, proposes to test prospectively the hypothesis that genetic~     modifiers influence the iron overload status of patients receiving transfusions. To test this~     hypothesis, the study will perform genetic studies to investigate possible genetic influences~     for iron accumulation in the body and will study iron accumulation not only in the liver, but~     also in the heart, pancreas, kidneys, and spleen. In addition: the study will investigate if~     these same genes have any role during treatment of iron overload, in other words, if certain~     genetic mutations will influence how iron exits the body. This study will also investigate~     how substances that are known to control the trafficking of iron in and out of the body and~     its damaging effects to the tissues (hepcidin and non transferrin-bound iron) are linked to~     the accumulation of iron in the heart and liver. Iron in the body will be measured by R2*MRI~     and no liver biopsies will be required. Genetic studies will be done by specialized tests~     using peripheral blood DNA.~      Iron accumulates differently in different people and in different organs of the body. Some~     people accumulate iron faster than others, even when receiving the same number of blood~     transfusions~   "
183816|NCT01158781|"~     The purpose of this study is to restore life role participation for those with TBI by~     customizing, applying, and testing integrated cognitive and motor training protocols that~     were successful in populations with impairments similar to TBI. The treatment protocols are~     based on principles of brain plasticity and re-learning, required to restore cognitive and~     motor function. The intervention targets an array of impairments that are obstacles to life~     role participation. These include cognitive attention and executive control; motor control~     for upper limb function; balance and gait; and cognitive executive control of simultaneous~     cognitive and motor tasks required by everyday tasks. The intervention utilizes training~     specificity, framing the intervention within functional task and life role activity component~     practice.~   "
183817|NCT01158768|"~     Objectives - To construct and validate a questionnaire evaluating violence suffered by women~     during any phase of their lives and health repercussions during climactery.~      Method: A controlled study with the application of a questionnaire at the Outpatient Clinics~     for Endocrine Gynecology and Climactery of the University Hospital (Hospital das Clínicas) of~     the Medicine College of the University of São Paulo (FMUSP), Brazil, performed during 2009~     for 124 women aged between 40 and 65 years, who were victims of domestic and/or sexual~     violence, distributed in three groups regarding the phase in which their experience with~     violence occurred: 1. Violence exclusively during childhood/adolescence; 2. During adulthood;~     3. Throughout all phases. The instrument encompasses 13 key questions and 21 sub items~     evaluating: 1. Place of residence and who the woman lives with; 2. Start, frequency and type~     of violence; 3. Search for health assistance and report of the violence; 4. Violence and~     number of affections; 5. Violence and Menopausal Kupermann Index (IMK).~      Results: The instrument presented Cronbach Alpha=0.82, reliability among examiners (+0,80),~     and good possibility to be reproduced. Average age of the women was 55,8 years (±6,6),~     menopause at -45,4 years in average, in the control Group (GC) it was 48,1 years; first~     sexual intercourse 19,5 years (GC = 21,0); menarche 13,1 years, and average BMI (Body Mass~     Index) 28,5 (±2,8), similar to the GC, but frequent violence during adulthood showed a BMI of~     30,0 (±2,8). Women who were submitted to violence exclusively: during childhood 14,5%;~     adolescence 1,6%; adulthood 41,9%, during all phases of their lives 42,0%. Women subjected to~     violence during childhood/adolescence (58,1%) presented an average of 5,1 affections; during~     adulthood, 4,6 and 4,4 for both phases. Sexual violence (43,5%) and other types of violence~     both present average affections (4,60) but represent a significative impairment of sexual~     life. There were significative associations between suffering any type of violence during all~     phases of their lives, sexual violence during any phase of their lives and a serious IMK.~     Among those women, 80,6% did not search health services due to the violence suffered.~      Conclusion: The questionnaire presents good internal consistency and a validated~     construction, can be easily reproduced and is indicated to evaluate the consequences of~     domestic and/or sexual violence on women´s health during climactery.~   "
183818|NCT01158755|"~     Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is~     diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased~     considerably during the last decade, partly due to the HIV epidemic. Without treatment,~     virtually all patients with TB meningitis will die. With the current treatment regimens, TBM~     is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar~     proportion of survivors.~      Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000~     new patients / year. Representative data are lacking, but it is clear that TBM is a growing~     problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java~     Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the~     late 90's compared to approximately 100 in recent years.~      There is very little evidence for the current treatment regimen for TBM, which dates back to~     the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM in~     randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly also at~     high dose), or both will improve outcome of TBM. To determine the experimental regimen(s)~     which should be compared with current regimen in phase 3 trials, we want to evaluate~     pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60~     patients with TBM in Indonesia.~   "
183819|NCT01158742|"~     Kidney transplantation from living donors has been shown to carry many benefits over deceased~     donor transplantation. Because of benefits such as shorter waiting times and improved outcome~     for transplant recipients, living kidney donation accounts for an increasing number of kidney~     transplants nationwide. Most published studies about living kidney donation demonstrate that~     the procedure is safe, but they also emphasize concerns that long-term data on live donor~     outcomes are insufficient. In particular, data concerning the extent of renal function~     decline after donation are inadequate. This study will measure glomerular filtration rate~     (GFR) in previous living donors and aims to more accurately describe renal function after~     kidney donation.~   "
183820|NCT01158729|"~     A prospective, randomized, placebo-controlled, double-blinded pilot study is planned.~     Neonates undergoing surgeries requiring cardiopulmonary bypass will receive antithrombin III~     (ATIII) supplementation or placebo in addition to standard anticoagulation with heparin as~     currently practiced at Children's Hospital of Wisconsin. We plan to enroll the first 60~     sequential patients meeting criteria who consent to inclusion. The primary outcomes will be~     rates of adverse events to monitor safety. Secondary outcomes include volume of postoperative~     blood loss and packed red blood cell transfusion during the first 24 postoperative hours, and~     ATIII levels during and after bypass to determine pharmacokinetics.~   "
183821|NCT01158716|"~     Elective percutaneous coronary intervention (PCI) is associated with troponin release in~     approximately one third of cases. Myocardial necrosis may result from downstream embolization~     of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion~     injury. The investigators hypothesized that a single remote ischemic preconditioning cycle~     would reduce peri-procedural troponin release.~   "
183822|NCT01158703|"~     The design of the study will be randomized, double blind trial, which will examine the~     effects of addition of clopidogrel to current guideline recommended background therapy on~     lowering the incidence of graft stenosis after coronary artery bypass grafting compared to~     placebo.~   "
183823|NCT01158690|"~     The study composes of two large parts, in particular a large scale prevalence/incidence study~     and a single-blind randomised controlled trial (RCT). The prevalence/incidence study aims to~     determine the prevalence/incidence of physical, psychological and sexual violence in a~     pregnant population. The study population is recruited through the prenatal consultation of~     more or less 15 hospitals in Belgium. The respondents fill out a questionnaire on the spot~     minimum one time during pregnancy. Based on this questionnaire, the investigators aim to~     recruit 150 victims of intimate partner violence (IPV) to participate in the second part of~     the study. The RCT aims to evaluate if there is a safe and effective way to reduce IPV within~     the perinatal care setting. The investigators hypothesise that screening pregnant women for~     violence in combination with handing out a resource card, has the potential of interrupting~     the IPV and increase help-seeking behaviour.~   "
183824|NCT01158677|"~     Short term outcome after meniscectomy: a meniscectomy is a very frequent performed~     orthopedically procedure. The short term outcome is favourable, but some patients keep having~     residual lesions after surgery.~      This prospective study examens the clinical outcome after meniscectomy using questionnaires~     (KOOS, VAS, SF-36, Tegner) (before the surgery, 3, 6 & 12 months postoperative.) The~     investigators will also record the further treatment options for the people at risk.~   "
183825|NCT01158664|"~     Patients who need more than 2 dental implants will be treated by the same implant type~     (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en~     1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is~     registered around these implants. The role of the thread pitch design will be investigated.~   "
183826|NCT01158651|"~     The purpose of this research study is to learn if the study drug RAD001 can shrink or slow~     the growth of low-grade gliomas in children with NF1. Additionally, the safety of RAD001 will~     be studied.~      The study drug, RAD001, is a drug that may act directly on tumor cells by preventing tumor~     cell growth and development. RAD001 has been studied in participants with various types of~     cancer as a single agent (a drug that is used alone to treat the cancer) or in combination~     with a number of well known anticancer therapies. Information from these research studies~     suggests that RAD001 may help to shrink or slow the growth of low-grade gliomas.~      In this research study, the investigators are looking to see the response of RAD001 in~     children with low-grade gliomas and NF1 that have either not responded to treatment or have~     come back after treatment. We are also looking for the highest dose of RAD001 that can be~     given safely in this patient population.~   "
183827|NCT01158638|"~     Individually tailored, mediated pedometer feedback will provide an effective method to~     promote physical activity adoption in the elderly~   "
183828|NCT01158625|"~     The purpose of this study is to investigate if it is possible to lower the nighttime blood~     pressure in patients with type 2 diabetes mellitus by shifting the administration of~     antihypertensive drugs from morning to nighttime.~   "
183829|NCT01158612|"~     Tendon and ligament injuries are a frequent problem among athletes but also in the general~     population. The healing process is a prolonged process, and complete recovery of tissue~     strength is nearly never reached. The purpose of this study is to examine the effect of local~     injection of human Growth Hormone on tendon collagen synthesis.~   "
183830|NCT01158599|"~     This is an open-label, uncontrolled phase 4 study to assess the safety and immunogenicity of~     the Japanese encephalitis (JE) vaccine Ixiaro® (IC51) in an elderly population.~   "
183831|NCT01158586|"~     Postoperative epidural analgesia (EA) is an effective and well-accepted modality of pain~     relief technique after having total knee replacement operation(1,4). Patient controlled~     epidural analgesia (PCEA) has been shown to be safe and effective in standard ward setting(2)~     and results in reduced epidural analgesic requirements(3). Besides, it also bear the~     advantage of avoidance of overdose, reduction of waiting times and involvement of patients in~     their analgesic regimen(3). Both ropivacaine and levobupivacaine are the local anaesthetic~     using in epidural analgesia which has been proven to be safe and effective(4). 0.2%~     Ropivacaine with 2ug/ml fentanyl has been used in our locality for more than 8 years. Another~     local anaesthetics, levobupivacaine, a S-enantiomer of bupivacaine has come up in Hong Kong,~     which has been proved to be safe, effective and may be better value for money. These two~     drugs has been proven to have similar analgesic potency in using as EA for postoperative pain~     relief for other operation(5,6,7) and for orthropaedics operation but in different~     concentration(4). Concerns have been raised about the introduction of the levobupivacaine in~     the departmental protocol. Objectives of this study are A)to determine the equivalence of two~     local anaesthetics regimen ; 0.2% ropivacaine with 2ug/ml fentanyl and 0.2% levobupivacaine~     with 2ug/ml fentanyl and B) to assess the cost-effectiveness of using these two regimens.~      The null hypothesis is that the difference of analgesic effect, presented with visual~     analogue score, of two patient controlled epidural analgesia regimen, the 0.2% ropivacaine~     with 2 ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl is higher than the~     threshold of 9 mm VAS. (8,9,10)~   "
183832|NCT01158573|"~     The purpose of this study is to examine whether there are higher levels of cysteinyl~     leukotrienes in obese subjects than in non-obese subjects. Cysteinyl leukotrienes are~     pro-inflammatory substances that cause asthma by narrowing the airways of the lung. The~     investigators want to see if subjects with increased fat stores and therefore increased~     leptin, which is a fat-related protein that regulates leukotrienes, have increased levels of~     leukotrienes in the blood, lung and urine. The investigators would also like to determine the~     relationship between cysteinyl leukotrienes and exhaled nitric oxide levels in asthmatics~     with and without obesity. Nitric oxide is anti-inflammatory and suppresses leukotriene~     synthesis.~   "
183833|NCT01158560|"~     The specific objectives of this investigation are to assess the effectiveness of daily~     gargling and vitamin D supplementation as preventative measures against incident upper~     respiratory tract infection (URTI) in students attending McMaster University. Investigators~     hypothesize that~        1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory~          tract infections in university students~        2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections~          in university students.~   "
183834|NCT01158547|"~     The purpose of this study is to assess the ability of CLR3001 to reverse depressive symptoms~     relatively quickly in adult patients with major depressive disorder (MDD).~   "
183835|NCT01158534|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Recombinant interferon alfa-2b may interfere with the growth of~     cancer cells and slow the growth of kidney cancer. Giving celecoxib together with recombinant~     interferon alpha-2b may kill more tumor cells and be an effective treatment for metastatic~     kidney cancer.~      PURPOSE: This phase II trial is studying how well giving celecoxib together with recombinant~     interferon alfa-2b works in treating patients with metastatic kidney cancer who have~     undergone surgery.~   "
183836|NCT01158521|"~     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving pazopanib hydrochloride before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works when given~     before surgery in treating patients with kidney cancer.~   "
183837|NCT01158508|"~     Rupture of brain aneurysms is a common cause of death and disability, accounting for as many~     as 10% of stroke cases in the United States. While much of the resulting injury to the~     nervous system is caused by the initial bleeding from the aneurysm, many of these patients~     develop cerebral vasospasm, pathological constriction of the blood vessels supplying the~     brain, several days following hemorrhage. As many as a third of patients can suffer a~     resulting neurological deficit and stroke, presumably caused by the decreased blood flow to~     the brain (ischemia). This delayed brain injury accounts for a significant percentage of poor~     outcomes following aneurysm rupture. Studies have shown that remote ischemia to many organs~     can precondition other tissues (including the brain) to be more tolerant to decreases in~     blood flow. This remote ischemic preconditioning has the promise of protecting the brain~     from ischemic injury. Whereas in other forms of stroke the onset of ischemia cannot be~     predicted in the general population, following aneurysm rupture the investigators know which~     patients are likely to develop vasospasm and when. Therefore, ischemic preconditioning~     following aneurysm rupture may help prevent some of the ischemic injury caused by vasospasm.~     Remote ischemic preconditioning by transient limb ischemia (produced by inflation of a blood~     pressure cuff on the arm or leg) has been shown to minimize injury to other organs, most~     notably the heart. Remote ischemic preconditioning of the brain following aneurysm rupture~     has not yet been investigated.~   "
183838|NCT01158495|"~     To implement a new method of performing chest CT imaging in young children at Packard~     Children's Hospital entitled controlled ventilation infant/young child chest CT scanning.~     This technique will be used to evaluate early lung disease comparing quantitative chest CT~     air trapping and airway measurements with lung function measurements in infants, toddlers,~     and young children with chronic lung disease.~   "
183839|NCT01158482|"~     A data registry for all patients who undergo IVC (Inferior Vena Cava) filter placement or~     retrieval at Stanford. Potential enrollees will already be undergoing the procedure. If~     patients are willing, they will be prospectively enrolled prior to the procedure. As part of~     the study, chart and clinical data reviews will be used to track patient progress and~     response to the treatment.~   "
183840|NCT01158456|"~     Metabolism and DNA adduct formation are critical in cancer induction by NNK. The~     investigators goal is to understand whether the observed ethnic/racial differences in lung~     cancer incidence are due to variations in NNK metabolism. The investigators overall~     hypothesis is that cancer susceptibility relates to carcinogen dose and to the balance~     between carcinogen metabolic activation and detoxification. The investigators propose to test~     this hypothesis via investigation of potential differences in NNK metabolic activation and~     detoxification in African American and European American smokers.~   "
183841|NCT01158443|"~     This is an integrated medication/behavioral intervention program to increase energy, activity~     level and goal attainment in a sample of HIV+ adults whose presenting problems include both~     clinically significant fatigue and unmet vocational goals. Based on previous studies, the~     investigators found that many patients fail to achieve desired goals even though energy is~     restored by medication. To address this failure of goal attainment, the investigators will~     evaluate a behavioral intervention, originally based on Behavioral Activation Treatment for~     Depression, and modified as Behavioral Activation Program for Energy and Productivity or~     BA-PEP. The intervention will be conducted with patients who experience clinically~     significant fatigue and who want to work or receive work-related training (paid or volunteer,~     part time or full time) or education once energy improves with medication (armodafinil).~   "
183842|NCT01158430|"~     The purpose of this study is to determine the effect of Acceptance and Commitment Therapy~     (ACT) in groups on functional level, emotional problems, and use of health care in patients~     with severe health anxiety in a randomized, controlled design.~   "
183843|NCT01158417|"~     The main objective of this study is to investigate the effect of resveratrol on inflammatory~     mediators and insulin resistance at the cellular and molecular level in obese non diabetic~     and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that~     resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in~     reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor~     nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that~     resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and~     oxidative response, will also be investigated. This research will also investigate the~     hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the~     Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance~     and, that resveratrol intake will cause an increase in incretins.~   "
183844|NCT01158404|"~     The objective of this phase 1 study is to evaluate the safety and tolerability of Notch~     Inhibitor in patients with advanced cancer. This study includes dose escalation and dose~     confirmation components.~   "
183845|NCT01158391|"~     The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age)~     who undergo the NTrainer System® training will transition to full oral feeds faster than the~     control group (i.e. the study group will be superior to the control).~      The secondary hypothesis is that the infants in the NTrainer System® experimental group will~     have shorter lengths of stay.~   "
183846|NCT01158378|"~     The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural~     Sealant System when used as a dural sealant in conjunction with standard methods of dural~     repair in cranial procedures.~   "
183847|NCT01158365|"~     Primary Objective:~      - To prove the efficacy superiority in reducing the genital odor and increase hydration in~     mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal~     Soap Granado Traditional~      Secondary Objective:~      - To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.~   "
183848|NCT01158352|"~     Study design:~      Double blind, randomized, placebo controlled study.The proposed study will consist of two~     main segments:~        1. Segment 1 is aimed to assess the effect of 6-12 months treatment with nutritional~          supplementation standardized formula, in short and lean prepubertal children on weight~          SDS, height SDS, BMI SDS and growth velocity~        2. Segment 2 is aimed to explore the eating behavior of idiopathic short stature and lean~          prepubertal children against their sibling who have a normal height and body weight and~          to find out whether there is a difference in eating patterns and quality of life between~          idiopathic short stature and lean prepubertal children and children with normal height~          and body weight~      Segment 1~      Population:~      200 subjects and controls will be recruited to segment 1 of the proposed study, 100 at each~     group.~      Participants will be recruited from healthy children who will be referred to either the~     institute for endocrinology or the gastroenterology unit, at Schneider Children's Medical~     Center for growth assessment, due to low height and weight, in whom, no gastrointestinal~     morbidity or other underlying cause was found.~      Methods:~      Randomization & Blinding:~      Participants will be randomly assigned either to the intervention group or the placebo~     control group. Randomization for the two study groups will be made in a ratio of 1:1. Both~     participants and study team will be blinded to the type of treatment that each patient will~     receive during the first 6 months of the study.~      Treatment:~      Participants in the intervention group will be treated with a nutritional supplementation~     standardized formula.Participants in the control group will be instructed to consume the same~     volume of formula as was calculated if they were in the intervention group.~      Treatment duration:~      The study will be divided into two treatment periods: 6 months of intervention versus active~     placebo followed with additional 6 months (an extension period), in which participants at the~     intervention group will be offered to extend the intervention period and participants at the~     control arm will be offered to switch to the intervention group.~      Study Schedule:~      Follow up visits will take place at 0, 3, 6, 9 and 12 months and will include:~        1. Demographic data, medical history and growth data (month 0):~           Demographic parameters, including birth date, gender, birth weight and length for~          gestational age, medical history and growth data, including height velocity, parent's~          and sibling's weight and height will be documented from patient's file.~        2. Nutritional assessment~        3. Anthropometric assessment (months 0, 3, 6, 9 12):~             1. Height without shoes~             2. Length~             3. Weight with light cloths and without shoes~             4. MAC~             5. Body mass index (BMI) will be calculated from children's weight and height and age~               and gender specific BMI SDS will be calculated~             6. Body composition assessment using the method of bioelectrical impedance~        4. Laboratory parameters (months 0, 6 and 12):~        5. Sleeping Questionaire~      Segment 2:~      86 subjects and controls will be recruited to segment 2 of the proposed study~      Population:~      Short and lean prepubertal children participating at segment 1 of the study and who are at~     study entry under 10th percentile in height, when the weight percentile is equal or smaller~     to the height percentile. Only participants from segment 1 who have siblings with normal~     height and body weight for age and gender, will be able to participate in segment 2 of the~     study~      Control group 1:~      Sibling of participants in segment 1 of the study, who have a normal height- above 25th~     percentile and normal BMI for age and gender- above 5th percentile and under 85th percentile.~      Control group 2:~      Healthy children from the community who have a normal height above 25th percentile and normal~     BMI for age and gender above 5th percentile and under 85th percentile~      Segment 2 of the study will be designed as a case- control study and will focus on the eating~     patterns, sleeping patterns and quality of life of participants at segment 1 at time 0 month~     of the study, before the beginning of the nutrition intervention. These findings will be~     compared to data of a control group, which will be comprised of siblings of participants in~     segment 1, with normal height and body weight which are matched in age.~   "
183864|NCT01158144|"~     Concomitant chemoradiotherapy is the standard treatment of locally advanced, non-resectable,~     non-small cell lung cancer (NSCLC). However, the optimal chemotherapy regimen is still~     controversial. The purpose of this study was to evaluate the efficacy and toxicity of a~     concomitant treatment using Endostar (Recombinant Human Endostatin), Paclitaxel/Carboplatin~     and radiotherapy for LA-NSCLC, and also assess its impact on patient Quality of Life (QoL)~     and progression-free survival (PFS).~   "
183849|NCT01158339|"~     Unspecific low back pain (LBP) is a major world wide health problem. The purpose of this~     study is to improve the care of LBP.~      Our hypothesis is that Cognitive Behavioural Therapy (CBT) with physical intervention during~     group sessions focusing on fear and avoidance behaviour will be more effective than physical~     therapy alone.~      The study has two arms. Both will receive education related to LBP and appropriate advice~     regarding how to react and behave towards their LBP.~      The main focus in the intervention group will be:~        -  Identifying their fear of movements and perform the frightened movements during the~          group sessions.~        -  Reassuring that gradually normalizing daily activities will not be harmful but rather~          reduce their pain.~   "
183850|NCT01158326|"~     This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol,~     chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the~     common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be~     included 216 subjects, male or female, aged greater than 12 and less than or equal to 60~     years, irrespective of color and / or race with symptoms of recent onset, for more than 6~     hours and less than 48 hours length, characterizing Common Cold and / or Influenza.~      After clinical evaluation and laboratory research subjects will be randomized to receive~     active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits~     will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first~     intervention).~      The outcomes to assess the effectiveness so far consist of the scores of symptoms and to~     assess the safety of the drug will be accompanied by the emergence of adverse events.~   "
183851|NCT01158313|"~     Previous studies have shown that most patients with functional oropharyngeal dysphagia could~     be quickly, safely and accurately recognized by using a clinical bedside method developed by~     the investigative team as the volume-viscosity swallow test (V-VST) that systematically~     evaluates the main clinical signs and symptoms of safety and efficacy of swallowing and~     monitors pulse oximetry to improve the detection of patients with silent aspirations.The aim~     of this study is to validate this test for persons suspected of having swallowing impairment,~     using a new thickener, with respect to the Videofluoroscopy (VFS) method (treated as the gold~     standard).~   "
183852|NCT01158300|"~     RATIONALE: PTC299 may stop the growth of tumor cells by blocking blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and the best dose of PTC299 in~     treating young patients with recurrent or refractory primary central nervous system tumors.~   "
183853|NCT01158287|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating~     patients with relapsed esophageal cancer and/or stomach cancer.~   "
183854|NCT01158274|"~     This phase I clinical trial is studying the side effects and best dose of RO4929097 when~     given together with capecitabine in treating patients with refractory solid tumors. RO4929097~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving RO4929097 together with~     chemotherapy may kill more tumor cells.~   "
183855|NCT01158261|"~     The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study~     is to observe the clinical safety performance of EVICEL when used as suture support for~     haemostasis in vascular surgery.~   "
183856|NCT01158248|"~     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving panitumumab and cisplatin together with pelvic radiation therapy may be~     effective in treating patients with cervical cancer.~      PURPOSE: This phase II trial is studying the side effects of giving panitumumab and cisplatin~     together with pelvic radiation therapy in treating patients with stage IB, stage II, or stage~     III cervical cancer.~   "
183857|NCT01158235|"~     This is a pilot study conducted to evaluate the safety, local tolerability and efficacy of~     LTX-109(Lytixar™), a lytic peptide designed to kill bacterias quickly and efficient. LTX-109~     (Lytixar™)will be applied in the anterior nares in subjects who are carriers of nasal~     colonies of MRSA/MSSA.~      The extent of systemic absorption of LTX -109 when applied to the anterior nares will be~     evaluated and the effect of Lytixar™ as to clear colonies of MRSA/MSSA during the the~     observation period and Week 2 to Week 9 after treatment.~   "
183858|NCT01158222|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth or by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating~     patients with previously untreated metastatic kidney cancer.~   "
183859|NCT01158209|"~     The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV~     type distribution among women aged >= 18 years, attending out-patient health services for~     gynaecological examination and who agree to HPV testing in Egypt .~   "
183860|NCT01158196|"~     A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a~     randomization of laser treated portions, and other with keloid excision scar with a complete~     laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid~     recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit,~     and the scar prevention in plastic surgery will be evaluated comparing laser treated portion~     and non-treated portion.~   "
183861|NCT01158183|"~     A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS)~     population capturing outcomes reported by patients and by the physicians during 12 months~     after initiating or resuming Betaseron.~   "
183862|NCT01158170|"~     RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in~     patients with advanced non-small cell lung cancer. It is not yet known whether radiation~     therapy is more effective than observation in patients with advanced non-small cell lung~     cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see~     how well it works compared with observation in preventing brain metastases in patients with~     advanced non-small cell lung cancer~   "
183865|NCT01158131|"~     Many studies have shown that women with a history of gestational diabetes mellitus (GDM) have~     an increased risk of developing diabetes later in life. The purpose of the study is to test~     whether a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes~     Prevention Program (DPP), modified specifically for women with a recent history of GDM,~     incorporating advice about diet and physical activity, delivered in the first 12 months after~     delivery will help women lose weight, improve overall health, and decrease their risk factors~     for type 2 diabetes.~   "
183866|NCT01158118|"~     This study will gather information about the combination the drugs plerixafor with~     sargramostim in donors of blood-forming cells (stem cells). These stem cells will be~     collected from the donor and transplanted into their sibling. The investigators believe that~     the two drugs together will provide enough stem cells for transplantation and may also reduce~     the risk of graft versus host disease.~   "
183867|NCT01158105|"~     The purpose of this study is to see if bortezomib (Velcade) is effective in the treatment of~     refractory cGVHD.~   "
183868|NCT01158092|"~     The purpose of this study is to evaluate the effectiveness of cooled radiofrequency~     denervation of the sacroiliac region using the SInergy System compared to conservative~     treatment in the treatment of sacroiliac joint pain.~   "
183869|NCT01158079|"~     This study provides a mechanism for continued administration of ALN-VSP02 therapy to patients~     with cancer who completed participation in another ALN-VSP02 clinical study. The primary~     objective of this study is to collect long term safety data.~   "
183870|NCT01158066|"~     Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general~     population and are being considered the most common cause of death. Cardiac CT is a reliable~     non invasive method in demonstrating Coronary Plaques. However the association between~     coronary artery calcium score (CAC) and NAFLD remains controversial~   "
183871|NCT01158053|"~     The present prospective, multicenter study will therefore be performed with the primary~     objective of establishing the correlation between fractional flow reserve (FFR) and~     intravascular ultrasound with virtual histology (VH-IVUS)-derived parameters in~     angiographically intermediate coronary lesions. The current study will also examine the~     relative prognostic utility of FFR and VH-IVUS as a tool to defer percutaneous coronary~     intervention (PCI), by assessing the long-term rate (up to 3 years) of lesion-related~     clinical events if deferred by FFR vs. VH-IVUS versus not deferred PCI.~   "
183872|NCT01158040|"~     The purpose of this study is to compare intrapartum glycemic control using insulin pump~     versus intravenous (IV) insulin administration.~   "
183873|NCT01158027|"~     The goal of the present study is to look at the effect of changing walking parameters on the~     dynamic walking characteristics among children post severe traumatic brain injury, and~     typically developed controls.~   "
183874|NCT01158014|"~     The use of Fibrin glue to place conjunctival graft will be as effective as suturing the~     graft, but will require much less operative time and will be better tolerated by the~     patients.~   "
183875|NCT01158001|"~     The objective of the proposed study is to conduct a systematic comparison of post traumatic~     stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine~     versus in-person care. The primary aim is to determine feasibility: whether telemedicine can~     be used as a tool to extend effective, specialized mental health services, such as Prolonged~     Exposure therapy (PE; a therapy designed to help clients face fears related to a traumatic~     event), to veterans with limited access to care. A secondary aim is to determine if therapy~     delivered by telemedicine affects the quality of care in terms of clinical outcomes and the~     quality of patient-therapist interaction. A tertiary aim is to examine whether results from~     neuropsychological testing predict treatment outcomes.~   "
183876|NCT01157988|"~     This phase II study is aimed at the clinical efficacy and toxicity of 6th R-CHOP chemotherapy~     followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage,~     bulky diffuse large B cell lymphoma (DLBCL).~   "
183877|NCT01157975|"~     Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2~     are refractory to medical treatment. Also, HCV replication seems to be affected when modeling~     insulin resistance in replicon cell culture systems.~      PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese~     subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity.~     Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect~     HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase~     HCV viral kinetics. .~   "
183878|NCT01157962|"~     Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women~     with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic~     dissection of lymph node and at the same time is accompanied with a considerably reduction of~     associated intra and post operative complications of lymph node dissection.~      For this purpose were randomized about 1200 patients with histological assured cervix~     carcinoma in stages FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0= 2 cm~     randomization. In the branch A takes place exclusively dissection sentinel lymph node, in the~     branch B takes place entire pelvic lymph node dissection. Afterwards takes place in tumor~     free lymph nodes the removal of uterus by a radical hysterectomy or, in presence of the wish~     of children, radical trachelectomy. In affected tumoural lymph nodes takes place systematic~     pelvic and peri aortic lymph node dissection followed by primary Radiochemotherapy.~      Primary end point is overall survival; this for both groups must be equal. Secondary end~     point is peri- and postoperative morbidity inclusive quality of life, the benefits for women~     must be evident with sentinel- lymph node dissection, don't have to show for both groups any~     significant difference.~   "
183899|NCT01157689|"~     The routine treatment of children with antimalarials will be monitored. Children with a~     positive malaria film and/or a positive rapid diagnostic test (RDT) will be included in a~     follow-up study. The genetic basis of the parasites for developing resistance will be~     examined. In case of reappearance of parasites the child will be re-treated following the~     guidelines of the national malaria programme.~   "
183949|NCT01157026|"~     Tocotrienol Rich Fraction (TRF) in combination with Tamoxifen will improve breast cancer~     specific survival and recurrence free survival, in women with early breast cancer and~     estrogen receptor positive tumors.~   "
183879|NCT01157949|"~     The purpose of this study is to test the hypothesis that administering Thymoglobulin®~     induction therapy early after transplant prevents the development of cardiac allograft~     vasculopathy (CAV). CAV accounts for a significant number of deaths in cardiac recipients~     after the first year of transplant. At 5 years post-transplant 30% of the deaths are due to~     CAV. With the exception of re-transplantation the available treatments for CAV are only~     effective at inhibiting its progression.~      CAV involves only the allograft and spares the native arteries, suggesting an immunologic~     basis for the disease. However, both immunological and non-immunological factors contribute~     to the development of CAV. The established immunological risk factors are recurrent rejection~     and humoral/antibody-mediated rejection (AMR). Non-immunological risk factors identified~     include preservation injury, the cause of donor death, donor graft ischemic time, and~     cytomegalovirus infection1. It is hypothesized that these factors increase the risk of~     developing CAV by causing early endothelial damage to the graft, which then could promote~     increased lymphocyte-endothelial interactions and the production of anti-endothelial~     antibodies2. The investigators hypothesized that Thymoglobulin induction therapy would~     prevent the development of CAV because its polyclonal nature allows Thymoglobulin to target~     all the potential mechanisms that contribute to the development of CAV—T-cell activation,~     B-cell activation, antibody formation, induction of tolerance, and modulation of~     lymphocyte-endothelium interactions3. Because the mechanism by which Thymoglobulin affects~     the immune system are still poorly understood, the investigators will also study how~     Thymoglobulin changes the immune system over time in the heart transplant recipient as a~     secondary objective.~   "
183880|NCT01157936|"~     The purpose of this study is to evaluate the influence of hyperuricemia treatment compared~     with placebo on participants with high risk of hypertension and metabolic syndrome.~   "
183881|NCT01157923|"~     Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to~     the standard of care of patients with type 1 diabetes.~      The objective of this feasibility study is to evaluate the efficacy and safety of automated~     determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration~     and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1~     diabetes.The study will be consisted from two segments:(I)pilot study, 30-78 days trial~     evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing~     MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to~     enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment,~     the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for~     dropouts.~      The randomized controled study segment will be initiated after the pilot segment.Each segment~     of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of~     30-78 days study duration for each segment. Before each clinic visit, subjects will wear~     continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations~     (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period~     according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin~     pump settings will not be changed during the study period (patient's usual standard of care).~   "
183882|NCT01157910|"~     Children with chronic otitis media have more resistant bacteria that require surgical~     intervention to eradicate the infections. The study will evaluate the dominant bacteria and~     their sensitivities to antibiotics. The information will assist in better treatment plans for~     children with chronic infections.~      The data will also assess the changing patterns in the bacteria colonizing middle ear fluid.~   "
183883|NCT01157897|"~     This is a first-in-humans safety, immunogenicity and efficacy study with recombinant~     proteinVMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open~     label study will be performed in malaria-naïve adults in the United States. Three doses of~     VMP001 formulated in AS01B will be given intramuscularly at different intervals followed by a~     challenge with P. vivax infected mosquitoes. Safety, immunogenicity and efficacy parameters~     will be studied.~   "
183884|NCT01157884|"~     The graft survival in kidney transplantation has been improving after the introduction of new~     immunosuppressive agents. Therefore, other complications after transplantation are concerned;~     one of those is obesity. Several factors are attributable to obesity in kidney transplant~     recipients.~      The body composition such as fat mass and lean mass is important concept in overweight~     patients. Some studies have been conducted on the change of body composition in kidney~     transplants. However, all of them are studied among Caucasians or using dual energy X-ray~     absorptiometry (DEXA).~      In this study, the investigators plan to study the body composition among Asian kidney~     transplant recipients using the bioelectrical impedance analysis (BIA).~   "
183885|NCT01157871|"~     The primary objective is to assess safety and efficacy of two different doses of NV1FGF as~     compared to placebo.~      The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.~   "
183886|NCT01157858|"~     The aim of this study is to reduce polycystic liver volume by treating with octreotide,~     whether or not combined with everolimus; to assess whether combination therapy of everolimus~     and octreotide gives a bigger reduction of polycystic liver volume than octreotide~     monotherapy.~   "
183887|NCT01157845|"~     The methacetin breath test (MBT) is a non-invasive liver function test which measures the~     ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is~     exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of~     a decline in liver function in patients with cirrhosis who are awaiting liver~     transplantation.~   "
183912|NCT01157507|"~     Previous clinical observations showed that Botulinum A toxin (BoNT/A) has also an~     antinociceptive effect and can control the neuropathic pain.~      In the urologic field, recent in in vitro and in in vivo studies demonstrated that the~     neurotoxin is able to inhibit the release of several neurotransmitters from the bladder~     afferent fibers and urothelium. These neurotrasmitters as SP, CGRP, ATP, NGF and~     Prostaglandins are involved in neurogenic inflammation. Thus, it is reasonable to hypothesize~     that patients with affected by painful bladder syndrome (PBS) could benefit from BoNT/A~     intravesically administered.~      The aim of the study is to investigate the clinical and urodynamic effects of an intravesical~     treatment with BoNT/A in patients affected by PBS associated with increased urinary~     frequency, who are refractory to conventional treatments. This treatment will be compared to~     bladder over distention, which is considered a conventional therapy.~   "
183888|NCT01157832|"~     Title: The acute effect of water pipe smoking on exhaled nitric oxide (eNO) and exhaled~     breath condensate (EBC) pulmonary function tests in healthy volunteers~      Objectives: To evaluate the acute effect of one cession of water pipe smoking on airway~     inflammation as assessed by exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) in~     healthy volunteers.~      Design: Prospective study evaluating these parameters before and after 30 minutes of water~     pipe smoking . The changes in inflammatory parameters pre and post smoking will be evaluated~     blindly.~      Sample size: 100 participants Participant selection: Adults subjects who regularly smoke~     water pipe . Intervention: Each subject will undergo evaluation including a respiratory~     questionnaire , pulmonary function tests , exhaled nitric oxide (eNO) and exhaled breath~     condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before~     and after one cession of 30 minutes water pipe smoking~      Primary outcome parameter: Change in carboxy- hemoglobin Secondary outcome parameter:Change~     in peripheral eosinophils count, pulmonary function tests, change in FeNO, and in~     inflammatory parameters in EBC before and after water pipe smoking~   "
183889|NCT01157819|"~     The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro (0.3%~     Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse~     Otitis Externa, compared to commercial ear drops used twice daily for 7 days.~   "
183890|NCT01157806|"~     Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal~     tumours and with unresectable metastases may prevent palliative surgery with a good~     palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of~     irradiation.~   "
183891|NCT01157793|"~     This was a 48-week, open-label, prospective, multicentric, randomised, comparative with~     parallel control, Phase 4 study to evaluate the effects of Saizen on cardiac function in GHD~     subjects during the transition phase from childhood to adulthood.~      The study was designed to evaluate whether recombinant-human growth hormone (r-hGH) treatment~     also benefits young subjects with GHD. Some trials have already been published on this~     subject, but they were mainly focused on the bone density.~   "
183892|NCT01157780|"~     Cholestatic liver disease is a common complication associated with long term parenteral~     nutrition (PN). PN associated liver disease (PNALD) is much more common in premature infants~     and the incidence increases with duration of PN. The use of intravenous omega-3 long chain~     polyunsaturated fatty acids (ω3PUFA) or fish oil has recently shown promise in the treatment~     of PNALD. We hypothesize that there are early markers for PNALD that precede the increase in~     total and direct bilirubin. We further hypothesize that patients with PNALD who receive~     enteral ω3PUFA supplementation will have an improvement in PNALD or reversal of PNALD. These~     hypotheses will be tested by a two part study that includes an initial observation period~     when markers for PNALD are evaluated, followed by a randomized, controlled trial of enteral~     ω3PUFA supplementation for treatment of PNALD. Infants expected to be on PN for 4 weeks or~     longer will be eligible for enrollment in this study. The observational part of the study~     will entail periodic assessment of potential markers for PNALD. Markers will be evaluated for~     inflammatory cytokines (IL-1, IL-6, TNF-alpha), oxidative stress (8-isoprostane,~     8-hydroxydeoxyguanosine, glutathione peroxidase), liver fibrosis (TIMP-1), endogenous steroid~     production (glucagon and ACTH), total serum bile acids, essential fatty acid profiles, and~     calprotectin, a novel marker of gut inflammation. Patients will be observed for 6 months~     duration. Patients enrolled in the study who develop PNALD will be randomized to either the~     current standard of care (control group) or enteral ω3PUFA supplementation (treatment group).~     Once able to take oral medications, treatment group patients will receive enteral ω3PUFA 1~     g/kg/day for 12 weeks. At the end of the 12 weeks, the protocol will be open label in which~     any patients who continue to have PNALD in either group will receive enteral ω3PUFA. All~     patients enrolled in the study (whether or not they develop PNALD or receive ω3PUFA~     supplementation) will be followed for a total of 6 months. The results of this study will~     increase our knowledge of the pathogenesis of PNALD, as well as potentially confirm the~     effectiveness of a novel therapy for this costly and debilitating disease.~   "
183893|NCT01157767|"~     The purpose of this study is to study if a patients follows an exercise program specifically~     designed for them during the time of their treatment after surgery. Their ability to follow~     the program and its influence on their weight maintenance and early post-operative lymphedema~     rates will also be studied. Lymphedema is a condition in which excess fluid collects in~     tissue and causes swelling of the arm(s).~   "
183894|NCT01157754|"~     Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH~     antagonist IVF cycles. The investigators performed this study to compare such a protocol with~     the gold-standard still today, which is the long-agonist protocol with no previous use of the~     pill.~   "
183895|NCT01157741|"~     Improved methods of community/home management and follow-up of severely undernourished~     children need to be developed in low-income countries like Bangladesh. The proposed study~     will be conducted at ICDDR,B Hospital and in different urban primary health care centres~     within Dhaka city. The efficacy of four different interventions will be evaluated/compared~     with control with respect to the rate of completion of clinical follow-up and growth,~     morbidity, and changes in psychomotor development in 500 children aged 6-24 months presenting~     to ICDDR,B with initial weight-for-age (WA) <-3 Z score. The interventions are:~        1. Usual follow-up (fortnightly for 1st 3 months) service at the hospital nutrition~          follow-up unit (HNFU) including growth monitoring and promotion + health education +~          micronutrient supplementation and treatment of intercurrent illness (current standard~          practice; control group).~        2. All management like control group, but follow up at community-based nutrition follow-up~          unit (CNFU) (fortnightly for 1st 3 months) (intervention A).~        3. All management like intervention A at CNFU + supplementary food (SF) for the first 3~          months (intervention B).~        4. All management like intervention A at CNFU + psychosocial stimulation (PS) for the first~          3 months (intervention C).~        5. All management like intervention A at CNFU + SF + PS for the first 3 months~          (intervention D).~      After the initial three months intervention period, children in all groups will be followed~     on fortnightly basis for next three months in their respective follow up unit.~      Follow-up rate, nutritional status, mental and psychomotor development, behavior, morbidities~     (including intestinal permeability in a sub-sample) of the children, and child rearing~     practices, depression and self esteem of mothers will be assessed in different groups.~      By ascertaining the most cost-effective/best management package, and by extending the package~     to other systems in the country, it will be possible to rehabilitate a greater number of~     severely malnourished children in their communities.~   "
183896|NCT01157728|"~     Cognitive impairment is one of the symptoms of Multiple Sclerosis (MS), and it may occur~     during the first years of the disease. It usually affects attention, information processing~     speed and short term memory. To date, the mechanisms of this specific symptom remain unclear~     (local or global inflammation, neurodegenerative processes).~      Magnetic Resonance Imaging (MRI) can be useful to understand the pathophysiology of cognitive~     impairment in MS. The investigators will combine conventional and non conventional MRI~     sequences to determine the respective role of white matter and grey matter injury and the~     cortical reorganization of neuronal networks.~   "
183897|NCT01157715|"~     This study is designed to access the safety and efficacy of multiple injections of KH902 at~     variable dosing regimens in patients with CNV due to neovascular AMD.~   "
183898|NCT01157702|"~     The purpose of the study is to verify the immunogenicity and tolerance of a trivalent~     seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the~     2010/2011 season for yearly licensing application.~   "
183950|NCT01157013|"~     Positron emission tomography (PET) with [18F]fluorodeoxyglucose (FDG-PET) evaluates cancer~     cell glycolysis(Warburg effect) as a surrogate for tumor response.The hypothesis of this~     study is that early changes in FDG-PET signal can predict sorafenib response in~     hepatocellular carcinoma (HCC).~   "
183900|NCT01157676|"~     This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and~     functional outcomes following two standard care procedures for radical cystectomy. The~     participants will have one of the standard care procedures as part of their care. The two~     procedures that will be followed are open radical cystectomy and robotic assisted radical~     cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While~     newer, RARC is considered to be equivalent to open surgery when it is performed by a trained~     robotics surgeon. The reported complication rates of RARC appear comparable to open surgery.~     This means there is no significant difference in the risk between the two standard~     procedures. However, despite these potential advantages, true comparison between the open and~     robotic technique with regards to long term cancer related and functional outcomes has not~     been accomplished because previous studies did not compare patients of equal health status.~     The researchers hope to learn whether or not patients undergoing RARC recover more quickly~     than or at the same rate as patients undergoing an open radical cystectomy while having non~     inferior cancer related outcomes. This study is funded by the National Institutes of Health~     (NIH).~   "
183901|NCT01157663|"~     Ankle sprain is the most occurring sport related injury. In addition, 40% of the people who~     sustain such an injury display residual symptoms under the general denominator functional~     ankle instability (FAI). In literature, there is already given a lot of attention to~     extrinsic and intrinsic risk factors of FAI. Furthermore, there is a major focus on the~     possible interventions which may be able to reduce the chance of developing chronic~     instability. At this moment there is a lack of unequivocality.~      In this study the investigators address the question of what is the effect of a balance~     training programme on the movement strategy. Therefore kinematics, kinetics, plantar pressure~     measurements and muscle activity are taken in consideration The purpose of this study is a~     better insight in the effect of treatment on the residual symptoms related to FAI.~   "
183902|NCT01157650|"~     Primary outcome measure:~      Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells~     implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse~     events occurred during the study.~      Secondary outcome measures:~        1. Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular:~             -  Fistulas healing efficiency~             -  Changes in quality of life in patients treated~             -  Changes of systemic Crohn's disease after implant~             -  Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem~               Cells treatment success.~        2. Achieving the biological characterization of the cell product used and its correlation~          with the therapeutic effect measured with:~             -  Phenotype study~             -  Suppressor capacity study.~             -  Citoquines production analysis~   "
183903|NCT01157624|"~     The investigators hypothesize that this new nasal cannula will prevent lack of oxygen as well~     as reduce rebreathing of carbon dioxide under ophthalmic drapes during eye surgery.~   "
183904|NCT01157611|"~     Purpose:~      To evaluate the effects of online based mentoring program on the blood glucose and~     satisfaction score in type 1 diabetes patients. Peer group mentoring will be as effective as~     guidance by the doctors.~      Methods:~      80 type 1 patients will be randomly divided into two groups (e.g. mentoring program group and~     control group). All patients will receive routine check up and blood test for ordinary type 1~     patients. In addition, program group patients should register their SMBG, exercise, food~     intake and insulin dose on the website designed for this study and receive advices of mentors~     from peer group. Every patient will submit questionnaire on the first day of the study and~     the last day(after 12 weeks) of the study.~   "
183905|NCT01157598|"~     Background: Endoscopic submucosal dissection (ESD) usually requires adequate level of~     sedation due to lengthy and uncomfortable procedure. Propofol induced sedation with~     bispectral index (BIS) monitoring has been reported to lead to higher satisfaction of~     patients and endoscopists during ESD. However, there is no data about efficacy of midazolam~     and meperidine induced sedation with BIS monitoring during ESD. This study was to evaluate~     whether midazolam and meperidine induced sedation with BIS monitoring could improve the~     satisfaction and reduce the dose of midazolam and meperidine during ESD.~   "
183906|NCT01157585|"~     The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients~     with first episode psychosis.~   "
183907|NCT01157572|"~     The primary objective of this study is to evaluate the effect of beta-blocker on left~     ventricular (LV) remodeling in asymptomatic patients with moderate to severe aortic~     regurgitation.~   "
183908|NCT01157559|"~     The aim of the study is to investigate the efficacy and safety of ziprasidone in patients~     with first episode psychosis.~   "
183909|NCT01157546|"~     This is a prospective, double blind, randomized study is proposed in patients undergoing open~     radical prostatectomy: its objective is to establish whether continuous bilateral TAP blocks~     would provide adequate perioperative analgesia, decrease opioid consumption, reduce the~     incidence of opioid-related side effects, and facilitate surgical recovery (in terms of PACU~     and hospital discharge).~   "
183910|NCT01157533|"~     The goal of this clinical research study is to learn if giving a larger than normal loading~     dose of the antibiotic vancomycin before starting standard vancomycin dosing can help~     patients reach and maintain the needed blood-level of the antibiotic during treatment.~   "
183911|NCT01157520|"~     Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under~     five minutes after local anesthetics administration. These changes are poorly depicted by~     oscillometric measurements. The investigators hypothesized, that a continuous noninvasive~     device detects more hypotensive periods with lower blood pressures.~   "
183913|NCT01157494|"~     In recent years Ferrari et al. proposed a new classification of manipulation in children with~     spastic hemiplegia which describes five different classes by analyzing and integrating the~     kinematic patterns of the hand and its functional use.~      The investigators believe that this classification provides the clinician with clinically~     meaningful information, by identifying the useful strategies spontaneously adopted by the~     children during manipulation tasks.~      The aim of this study is to determine the criterion validity of the new classification of the~     pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation~     classes with both the scores of the Assisting Hand Assessment and the scores of the Melbourne~     Assessment of Unilateral Upper Limb Function.~   "
183914|NCT01157481|"~     Patients with heart failure with preserved ejection fraction have a equally high risk for~     mortality and re-hospitalization as those with reduced ejection fraction. Effective~     management strategies are critically needed to be established for this type of heart failure.~     These patients have more hypertensive and ischemic etiology than those with reduced ejection~     fraction. The investigators hypothesis is that Ca channel blocker nifedipine can improve the~     heart failure clinical composite response endpoint compared with the conventional treatment~     in patients with heart failure with hypertension and/or coronary artery disease and preserved~     ejection fraction (>=50%) by echocardiography. This study is multi-center, prospective,~     randomized, open-label, and blinded-endpoint design.~   "
183915|NCT01157468|"~     -  The Martinique island (French West-Indies) is an area of high prevalence and incidence~          for Systemic Lupus Erythematosus (SLE), respectively 64,2/ 100000 and 4,7/ 100000. In~          many cases, this disease concerns Afro Caribbean women, whose auto-antibodies are~          excessively high; also, organic damages are frequent. The disease can be fatal.~        -  Studies have shown that some cytotoxic auto-antibodies may have a responsibility in the~          hydrolysing of DNA. This study will focus on the DNA activity and also on the overwhelm~          hydrolase activity dealing with the Lupus disease in order to measure the link between~          the disease activity and the catalytic activity. Patients concerned by this study will~          be Martinique people.~   "
183916|NCT01157455|"~     This is a prospective, multi-center registry to evaluate safety and effectiveness of the~     Everolimus Drug Eluting Stent for treatment coronary revascularization in Chinese patients~     with long lesion, small vessel or multi-vessel diseases.~   "
183917|NCT01157442|"~     Optimal development of sustainable health systems must use locally relevant infrastructure.~     Mobile phone technology, driven primarily by local market forces rather than foreign~     assistance, is spreading rapidly through African communities to improve people's personal and~     business communications. Here, the investigators propose using a structured mobile phone~     communications system for prevention of mother to child transmission of HIV (PMTCT). The~     system is designed to improve antenatal linkage to care, provide reminders to take PMTCT~     medications, and improve post-natal support and follow-up, even when mothers deliver at home.~     In addition to benefits in PMTCT related outcomes, this model allows evaluation of the~     intervention in a public health setting with the ultimate goal of advancing regional health~     systems development. The overall goal of of the study is to assess if mobile phones and SMS~     text messages can be used to help improve prevention of maternal to child transmission~     (PMTCT) of HIV services by strengthening health systems.~      Specific objectives are:~      1. To determine if mobile phone SMS text messages can demonstrate an improvement in~     compliance with a known intervention ( use of nevirapine) for PMTCT, demonstrated by:~      1a) improved antenatal care attendance (greater than 4 visits)~      1b) increased usage of nevirapine in labour (from 60% to at least 70%)~      1c) earlier identification and treatment of HIV positive infants~      1d) increased postpartum care for HIV positive mothers~      1e) acceptability of cell phone SMS text messages transmission of information among HIV~     positive women~      2. To demonstrate that mobile phone technology can be used as an effective tool to strengthen~     PMTCT health information systems at the facility level by: 2a) determining factors that~     constrain or promote the use of cell phone technology to strengthen PMTCT health information~     systems from the perspective of patients, health care providers and policy makers 2b)~     determining how cell phones can be used as a tool to generate equity statistics for PMTCT~     programs and formulate equity orientated PMTCT policies 2c) determine if early involvement of~     policy makers in the study improves knowledge translation~   "
183918|NCT01157429|"~     The purpose of this study is to show whether D-cycloserine in combination with cognitive~     behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of~     posttraumatic stress disorder (PTSD) in 13-18 year-old children.~   "
183919|NCT01157416|"~     The purpose of this study is to show whether D-cycloserine in combination with cognitive~     behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of~     posttraumatic stress disorder (PTSD) in 7-12 year old children.~   "
183920|NCT01157403|"~     Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the~     pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to~     control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been~     shown in many animal studies their potential cure for T1DM,which could not only address the~     need for β-cell replacement but also control of the autoimmune response to cells which~     express insulin. Therefore it is need to study the safety and efficacy of autologous bone~     marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.~   "
183921|NCT01157390|"~     Objective: To demonstrate the well-being of Chinese term infants fed with Wondersun formula~     with high proportion of palmitic acid in the sn-2 position.~      Design & setting: A single-center, open label study. A breast fed group will serve as~     reference. The study will be conducted in Guangzhou from 2010.1~2010.12.~      Participants: 0-14 d whole formula-fed infants and whole breast-fed infants, 30 infants in~     each group. They are required to be healthy, term-infant, and with normal birth weight, and~     have no medications known to affect their growth and development.~      Intervention: The formula-fed infants will be fed Wondersun formula with high proportion of~     palmitic acid in the sn-2 position; and breast-fed groups will be fed using breast milk for~     at least 3 month.~      Outcome measures: Tolerance and efficacy will be assessed by body measurement, stool~     characteristics questionnaire, general health examination, and behavior and habit~     questionnaire at baseline (0-14d), 6 weeks and 12 weeks. Safety will also be evaluated.~      Statistical analysis: t-test, rank test and chi-square test will be used to examine the~     significance of change from baseline to follow-up visit between the formula-fed and~     breast-fed groups for effectiveness measures~   "
183922|NCT01157377|"~     This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic~     overactive bladder (IOAB) and urinary incontinence.~   "
183923|NCT01157364|"~     This study will evaluate the safety and efficacy of new ophthalmic formulations of~     bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3~     formulations will be evaluated based on internal data review of each cohort. The study will~     be conducted in 2 stages. Stage 1 is open-label and Stage 2 is masked.~   "
183924|NCT01157351|"~     The study will assess the use of paliperidone palmitate compared with oral antipsychotic~     treatment in delaying time to a protocol-defined treatment failure over 15 months, in~     patients diagnosed with schizophrenia who have been incarcerated.~   "
183925|NCT01157338|"~     Retinal emboli is a common phenomenon in cardiac catheterization. In this study the~     investigators evaluate the incidence of retinal emboli post diagnostic and therapeutic~     cardiac catheterization over 300 patients. The incidence was 6.3% and had no clinical sequel~     on visual acuity and visual field.~   "
183944|NCT01157091|"~     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating~     patients with stage IV kidney cancer.~   "
183926|NCT01157325|"~     Currently, it is certain that neuraxial analgesia in early stage of labor and delivery dose~     not increase the risk of Cesarean section. However, given ethical reasons, whether such a~     medical procedure could increase the Cesarean rate compared with those who did not received~     neuraxial analgesia or not is yet to be known. It is difficult to perform such a study in~     occidental countries because they have a higher rate of labor analgesia. On the contrary, the~     rate of labor analgesia in China is up to date only 1%, so it can be done easily. The~     investigators hypothesized that no neuraxial analgesia itself were a risk factor to Cesarean~     section. Therefore, the investigators design this study to compared the effect of neuraxial~     analgesia on the rate of Cesarean delivery with those who did not received neuraxial~     analgesia.~   "
183927|NCT01157312|"~     The purpose of this study is to compare and determine the the efficacy of minimal stimulation~     and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic~     Ovary Syndrome(PCOS).~   "
183928|NCT01157299|"~     The purpose of this study is~        -  To assess the value of dynamics (SVV, PPV) and static indices (GEDVI, ITBVI, CVP) of~          preload and its combination with contractility (CI,SV, ventricular power, dP/dtmax, CFI,~          GEF) and lung water indices (ELWI), as predictors of fluid responsiveness in both~          spontaneously breathing and mechanically ventilated pediatric patients.~        -  To assess the value of stroke volume and pulse pressure changes from femoral pulse~          contour analysis (PiCCO2) during passive leg raising as predictor of fluid~          responsiveness in pediatric patients.~        -  To establish normal and cutoff values of transpulmonary thermodilution (PiCCO2)~          hemodynamic variables in hemodynamically stables and hemodynamically normal patients.~   "
183929|NCT01157286|"~     The investigators intend to study the prevalence of obstructive apnea in patients submitted~     to partial laryngectomy by larynx cancer. Volunteers will be evaluated using polissonografy.~     We will try to correlate the residual glotic area with the number of apneas per hour.~   "
183930|NCT01157273|"~     Objective: To assess whether the anxiety caused by a task considered anxiogenic, Simulated~     Public Speaking (SPS) test, would change the responses of healthy individuals regarding~     physiological and vocal parameters. Method: The sample comprised 30 participants of both~     genders, 19-42 years old, with no history of psychiatric disorders. The score in the~     STAI-Trait enabled investigators to assign participants to two groups: LOW ANXIETY (LA) and~     HIGH ANXIETY (HA). The investigators evaluated physiological parameters (heart rate, skin~     conductance, temperature in the extremities, electromyogram of the frontal muscle and~     salivary cortisol) and vocal parameters (vocal self-evaluation, quality of life in voice and~     vocal symptoms and signs) BEFORE, DURING and AFTER the SPS.~   "
183931|NCT01157260|"~     Indoxyl sulfate (IS) is a uremic toxin that accelerates the progression of chronic kidney~     disease (CKD). AST-120 (Kremezin®; Kureha Corporation, Tokyo, Japan) removes indole, which is~     the precursor of IS, in the intestine, and reduces the accumulation of IS. This drug has been~     shown to retard the deterioration of renal function in CKD patients through reducing the~     levels of IS.~      IS was reported to promote aortic calcification and stimulate the proliferation of vascular~     smooth muscle cells (VSMC). IS also inhibits endothelial proliferation and wound repair. With~     this background, the investigators will performed the study whether AST-120 improve the~     endothelial dysfunction in CKD patients.~   "
183932|NCT01157247|"~     Background and Objectives: Spinal puncture is painful procedure which may cause patient~     refusal of spinal anesthesia in future surgery. It could be minimized with topical and~     infiltration local anesthetic or intravenous opioid application before procedure. Objective~     was efficacy of intravenous fentanyl in alleviating pain during spinal needle insertion.~      Methods: Prospective, randomized study included 88 adults (33-55 ages, ASA I/II), scheduled~     for lower leg surgery. Patients were divided in four equal study groups: spinal needle~     (Quincke, 26G) with introducer (20G) was inserted alone, three minutes after local anesthetic~     infiltration (2 ml of 2% lidocaine, 25Gx11/4 needle) or intravenous fentanyl application~     (0.001 mg kg-1) and without local anesthetic, fentanyl and introducer. Pain was assessed~     immediately after procedure by VAS score. MAP, HR and SaO2 were recorded. Sedation was~     assessed by Ramsay score. Statistical analysis was performed by SPSS 11.0.~   "
183933|NCT01157234|"~     This study will investigate the blood pressure lowering efficacy of nebivolol among renal~     transplant recipients who are on calcineurin inhibitors which are believed to contribute to~     hypertension by sympathetic nervous system (SNS) activation and decreased prostaglandin and~     nitric oxide production. Hypotheses:~        1. There is a significant difference in the effect of 12 months of Nebivolol versus~          Metoprolol treatment on the plasma nitric oxide level of hypertensive renal transplant~          patients.~        2. There is a significant difference in the effect of 12 months of Nebivolol versus~          Metoprolol treatment on the estimated glomerular filtration rate of hypertensive renal~          transplant patients.~        3. There is a significant difference in the effect of 12 months of Nebivolol versus~          Metoprolol treatment on the systolic, diastolic and mean arterial blood pressures of~          hypertensive renal transplant patients.~   "
183934|NCT01157221|"~     Background: Few studies have examined the predictors of the clinical course of subjects with~     frozen shoulder syndrome or explained the persistence of symptoms after appropriate therapy.~     Altered shoulder kinematics may predispose subjects to subacromial impingement, rotator cuff~     tendonitis, altered shoulder joint forces, and possible degenerative changes. Subsequently, a~     more difficult and chronic course of frozen shoulder syndrome may develop.~      Objective: The purposes of this study are: (1) to develop a prediction method for determining~     altered shoulder kinematics and associated muscular activities which are associated with the~     chronicity of frozen shoulder dysfunction, and (2) to validate this prediction method and~     analyze the impact of the method on clinical behavior.~      Design: For the first year, a prospective study will be conducted to develop a prediction~     method that will identify impaired shoulder kinematics associated with the degree of~     symptom-related functional disability in patients with frozen shoulder syndrome. For the~     second and third years, validation of the proposed prediction method will determine whether~     altered shoulder kinematics and associated muscular activities subject to intervention meet~     the prediction criteria and demonstrate improvement in their follow-up, which will be shown~     to improve decision making in clinical practice.~   "
183945|NCT01157078|"~     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like~     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken~     together with another antidepressant.~   "
183935|NCT01157208|"~     The purpose of this study is: 1) To assess the feasibility of implementing a clinical trial~     comparing two potentially analgesic dietary interventions in patients with chronic daily~     headache (CDH) and 2)To assess the preliminary efficacy of the dietary interventions on~     headache frequency and severity and 3) to assess the impact of the diet on the percentage of~     omega-6 highly unsaturated fatty acids (HUFA) in total HUFA in whole blood.~      During a 6-week baseline phase, eligible individuals with CDH will complete web-based daily~     diaries, self-report questionnaires, and nutrient intake assessments. Before randomization to~     one of the two intervention groups, blood will be collected to measure baseline nutritional~     biomarkers. Targeted dietary advice will be administered and foods will be provided~     throughout the 12-week intervention phase. Samples for biomarkers will be collected every 4~     weeks during the intervention. Participants will continue recording headache characteristics~     with a daily headache diary. At the conclusion of the intervention, participants will provide~     complete follow-up assessments and blood for nutritional biomarker measurement.~   "
183936|NCT01157195|"~     Constraint-Induced Movement therapy, also known as CI therapy, is an approach to physical~     rehabilitation derived from basic behavioral and neuroscience research. It has been shown to~     be efficacious for rehabilitating use of the more-affected arm in individuals more than one~     year after stroke with mild to moderate motor impairment. The first component of the therapy~     is intensive training in use of the more-affected arm on functional tasks for 3 hours daily~     for 10 consecutive weekdays. The second is wearing a protective safety mitt on the~     less-affected hand for all waking hours of the approximately 2-week treatment period that it~     is safe to do so. The purpose of the mitt is to discourage use of the less-affected arm. The~     third is a group of behavioral techniques designed to transfer gains from the treatment~     setting to the real world, which takes a therapist, on average, 30 minutes to implement on~     each treatment day.~      The purpose of this project is to develop and test a method for automating the delivery of~     this efficacious treatment in a way that the therapy can be provided in stroke patients'~     homes. After developing an automated CI therapy workstation that has tele-health~     capabilities, the investigators will conduct a randomized controlled trial to evaluate~     whether CI therapy delivered in the home using this workstation with remote supervision by a~     therapist via an Internet-based audiovisual link provides outcomes that are just as good as~     CI therapy delivered by a live therapist.~   "
183937|NCT01157182|"~     The objective of this study was to determine and compare the rate and extent of absorption of~     norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone~     Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg~     norethindrone acetate) Tablets under fasting conditions.~   "
183938|NCT01157169|"~     The object of this study is to compare the rate and extent of absorption of an~     investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr~     Laboratories, Inc. to an equivalent oral dose of the commercially available reference~     product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least~     10 hours.~   "
183939|NCT01157156|"~     The primary objective is to evaluate safety and tolerability of single and repeated~     administrations of escalating doses of NV1FGF administered intramuscularly in patients with~     severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or~     Grade III, category 5 and 6).~      Secondary objectives are:~        -  To determine the biological activity of NV1FGF on collateral artery development.~        -  To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.~   "
183940|NCT01157143|"~     The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in~     injected tissue, at injection site, after Intra Muscular (IM) administration of increasing~     single doses of NV1FGF.~      Secondary objectives :~        -  To evaluate the safety and tolerability of IM administration of increasing single doses~          of NV1FGF~        -  To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site~          and remote site)~        -  To evaluate the presence of FGF-1 receptors in injected tissues (injection site and~          remote site)~        -  To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote~          site), in multiple organs/tissues when appropriate, and plasma~        -  To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at~          remote site~        -  To collect data from plasma NV1FGF pharmacokinetics~        -  To evaluate healing of the amputation site~   "
183941|NCT01157130|"~     The proposed study compares the outcomes of a physical activity intervention begun at~     diagnosis, continuing through active cancer treatment and into six months of survivorship~     compared to the outcomes of a control group receiving limited information on activity.~   "
183942|NCT01157117|"~     Food allergy affects up to 4% of the U.S. population and is most common in young children.~     Milk allergy is the most common cause of food allergy in infants and young children, and~     usually develops in the first year of life. There is no treatment for food allergy and the~     current standard of care for milk-allergic individuals is the avoidance of milk-containing~     products. Research is underway to identify potential therapeutic strategies to reduce or~     eliminate the adverse effects experienced by milk-allergic individuals when they consume~     milk-containing products.~      Several studies have suggested that milk-allergic children who receive milk protein oral~     immunotherapy (OIT) may become desensitized to milk, resulting in short term protection~     against accidental ingestion of milk products. However, these children did not develop~     tolerance, which is long term protection even after milk immunotherapy is stopped. A~     potential strategy to induce tolerance to milk uses milk in combination with Xolair®~     (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody~     involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in~     combination with milk protein OIT is safer and more effective than OIT alone in inducing~     tolerance to milk and milk products. Participants will be administered a double blind,~     placebo controlled milk challenge at various time points in the study. If desensitization is~     achieved participants will be tested for tolerance at a certain time point after stopping~     treatment.~   "
183943|NCT01157104|"~     This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug~     interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two~     drugs are administered in combination in healthy participants.~   "
183952|NCT01156987|"~     Today's medical imaging methods have insufficient specificity for reliable differentiation~     between benign and malignant breast lesions in patients. Pathologic evaluation is currently~     the only way to obtain a definitive diagnosis. This research will use a novel method of~     magnetic resonance imaging (MRI), Sweep Imaging with Fourier Transform (SWIFT), at a very~     high magnetic field (4 Tesla) to distinguish malignant from benign breast lesions. This~     research will reveal whether the SWIFT sequence bears new capabilities in medical imaging for~     breast cancer diagnosis.~   "
183953|NCT01156974|"~     Trained lay persons (care guides) working with chronic disease patients and their providers~     can help outpatients with diabetes, hypertension, and congestive heart failure achieve~     standard clinical care goals~   "
183954|NCT01156961|"~     This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in~     combination with paclitaxel as first-line treatment in patients with locally recurrent or~     metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg~     intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel~     will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175~     mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease~     progression or unacceptable toxicity occurs.~   "
183955|NCT01156948|"~     To compare the impact of 400-microgram self-administered vaginal versus self-administered~     oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to~     outpatient hysteroscopy.~   "
183956|NCT01156935|"~     Previous studies report low levels of mood and of quality of life among cancer patients.~     Laugh has been proved to improve mood and immune system function. The investigators propose~     to assess in a prospective randomised case-control study the affects of laugh-yoga~     intervention on mood levels and quality of life among cancer patients in a cancer clinic. The~     main hypothesis is that patients in laugh-yoga group will report higher mood and quality o~     life levels after intervention in comparison with no-intervention group. The second~     hypothesis is that immune system is the mediator of the effects of laugh-yoga intervention on~     mood and quality of life.~   "
183957|NCT01156922|"~     Based on pilot patient observations, and experience from the prior study KTS-1-2008, the~     investigators anticipate that severely affected chronic fatigue syndrome patients may benefit~     from B-cell depletion therapy using Rituximab induction with maintenance treatment.~      The hypothesis is that at least a subset of chronic fatigue syndrome (CFS) patients have an~     activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may~     alleviate symptoms.~      An approved amendment (April 15th 2011): the study will be extended with up to 5 patients.~     For up to 5 patients in the study, standard plasma exchange may be performed 2-3 weeks prior~     to start of B-lymphocyte depletion using Rituximab (as in the protocol).~      Approved amendment (December 2011): for patients with gradual improvement in CFS/ME symptoms~     after 12 months follow-up, but not having reached a clear response, up to 6 additional~     Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months~     period.~   "
183958|NCT01156909|"~     Based on pilot patient observations, and experience from the prior study KTS-1-2008, the~     investigators anticipate that chronic fatigue syndrome patients may benefit from B-cell~     depletion therapy using Rituximab induction with maintenance treatment.~      The hypothesis is that at least a subset of CFS patients have an activated immune system~     involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.~   "
183959|NCT01156896|"~     The primary study hypothesis of the investigators is that administration of an iron~     supplement between meals at a dose like that used in the Pemba trial (~1 mg Fe/kg) during P.~     falciparum parasitemia will increase plasma non-transferrin-bound iron. A key subsidiary~     hypothesis is that iron administered with meals in amounts used in food fortification (~0.1~     mg Fe/kg) will not produce plasma non-transferrin-bound iron.~      This research will be carried out at the Hospital for Tropical Diseases, Mahidol University,~     Bangkok, Thailand. The studies are intended to help understand how giving iron and folic acid~     to preschool children in Pemba, Zanzibar, Tanzania, (the Pemba trial) in the doses~     recommended by the World Health Organization, could have resulted in an increase in~     hospitalizations and deaths. The investigators will examine the most likely explanation, that~     the dose of iron supplements used in the Pemba trial produced iron in the blood not bound to~     the usual carrier for iron (a protein called transferrin), that is called~     non-transferrin-bound iron, abbreviated as NTBI. In children with malaria, this NTBI might~     favor the growth of malarial parasites or other causes of infection. At present, no studies~     have been carried out to see if NTBI is present after giving iron to patients with malaria.~     Using non-radioactive forms of iron (called stable isotopes), the investigators will study~     iron absorption and NTBI after giving a single dose of iron (like that used in the Pemba~     trial) one day after treatment for malaria has been started, while patients still have~     malaria parasites in the blood, and then again two weeks later, after the malaria has been~     cured. The investigators will study adults admitted to the Hospital for Tropical Diseases in~     Bangkok, Thailand, with malaria. For reasons of safety, the investigators have chosen to~     study adults in the hospital rather than children living in an area like Pemba but the~     results should also apply to children. The outcome of this research will help us design ways~     of safely giving iron in malarious areas to adults and children to prevent or treat iron~     deficiency.~   "
183960|NCT01156883|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) together with steroid therapy may kill more cancer cells.~      PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in~     treating young adult patients with acute lymphoblastic leukemia.~   "
183961|NCT01156870|"~     Primary Objective:~      To determine the maximum tolerated dose (MTD) of SAR566658~      Secondary Objectives:~        -  To characterize the safety profile of SAR566658~        -  To evaluate the pharmacokinetic profile of SAR566658~        -  To assess the potential immunogenicity of SAR566658~        -  To assess preliminary antitumor activity~        -  To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using~          midazolam~        -  To assess safety in the alternative schedules of SAR566658 administration~   "
183962|NCT01156857|"~     This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once~     daily for 3 months, blinded towards the administration of progestin or placebo after end of~     PGL4001 treatment.~   "
183963|NCT01156844|"~     This study assessed the bronchodilator efficacy of three different regimens of indacaterol in~     patients with asthma~   "
183964|NCT01156831|"~     The purpose of this study is to determine the locoregional control in PET/CT based~     radiotherapy treatment planning in the treatment of esophageal cancer patients.~   "
183975|NCT01156688|"~     The primary objective of this study is to compare the incidence of side effects of buccal and~     sublingual misoprostol when combined with mifepristone for medical abortions of less than 9~     weeks gestation. The secondary outcome is to compare the complete abortion rate and~     induction-abortion interval between the two methods of administration of misoprostol.~   "
183965|NCT01156818|"~     Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer~     that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence~     of wheezing. When used to monitor conditions such as asthma, this device should be used under~     the direction of a physician or licensed healthcare professional. The device is intended for~     use with pediatric and adult patients in both home and clinical settings.~      The purpose of the study is to determine whether Wz% and change in Wz% correlate with~     symptoms and change in symptoms at least as well as FEV1 and change in FEV1.0. Additional~     information to be obtained from the study will be to determine whether there is a symptom~     threshold at which a patient seeks rescue medications and if so, to determine the value of~     Wz% and FEV1.0 at this point (Wz%, FEV1.0 thresholds). The study will also provide~     information on the within patient and whole group correlations between Wz% and FEV.~   "
183966|NCT01156805|"~     ABSTRACT Objective: to evaluate the efficacy of an intervention on food habits and physical~     activity in school-age children.~      Methods: a two-year cluster-randomised prospective study with two parallel arms was used to~     evaluate an intervention programme in children in their first year of primary schooling (5-6~     years of age) in schools in the city of Granollers. The intervention consisted of the~     promotion of healthy eating habits and physical activity by means of the educational~     methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end~     of the study (2006 and 2008) the weight and height of each child was measured in situ, while~     the families were given a self-report physical activity questionnaire and the Krece Plus~     quick test.~      Results: two years after the beginning of the study, the BMI of the children in the control~     group was 0.89 Kg/ m2 higher than that of the intervention schools. The intervention reduced~     by 62% the prevalence of overweight children. Similarly, the proportion of children that ate~     a second piece of fruit and took part in an after-school physical activity increased in the~     intervention group. In the control group, the weekly consumption of fish was reduced.~      Conclusion: the educational intervention in healthy eating habits and physical activity in~     the school environment together with the involvement of the family could contribute to lessen~     the current increase in child obesity in our setting.~   "
183967|NCT01156792|"~     The primary objective of this study is to evaluate the efficacy and safety of adding~     GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone~     propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects > or~     = 12 years of age over the course of 6 weeks treatment.~      The secondary objectives are to undertake an exploratory analysis of the efficacy and safety~     of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice~     daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate~     the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects >~     or = 12 years of age over the course of 6 weeks treatment.~   "
183968|NCT01156779|"~     This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to~     characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects~   "
183969|NCT01156766|"~     The number of osteoporotic fractures, among which the fractures of the lower extremity of the~     radius (16 % of fractures seen in emergencies) is going to increase. Several surgical~     techniques are described in particular locking plates and intrafocal pinning techniques.~      The aim of the study is to compare (X-ray assessments and functional outcome) these two types~     of treatment by using a prospective, randomised multicentric analysis.~   "
183970|NCT01156753|"~     The main purpose of this study is to see whether CDX-011 is effective in treating patients~     who have advanced breast cancer that makes a protein called glycoprotein NMB (GPNMB), and who~     have already received (or were not candidates for) all available approved therapies for their~     breast cancer. This study will also further characterize the safety of CDX-011 treatment in~     this patient population.~   "
183971|NCT01156740|"~     The purpose of this study was to compare the microbiological effects of two different~     treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day~     daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource~     settings. This study was a prospective multi-center randomized active control treatment~     trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin~     treatment is at least as effective as the currently given IM BPG treatment.~   "
183972|NCT01156727|"~     This project added an evaluation/research component to an existing peer outreach program,~     implemented for over 1100 soldiers in the Michigan Army National Guard. The study aims were~     to: 1) evaluate the implementation of the B2B program to inform ongoing program modifications~     and facilitate future dissemination efforts, 2) assess whether the B2B program increases~     mental health and substance use treatment initiation and treatment retention among returning~     National Guard soldiers, and 3) explore whether the B2B program improves mental health~     symptoms, deceases hazardous alcohol use, and improves soldier well-being.~   "
183973|NCT01156714|"~     This study compares the effects treadmill exercise, computerized cognitive training, or the~     combination of the two on executive function, dual-task performance, and performance on~     several Instrumental Activities of Daily Living (IADLs).~   "
183974|NCT01156701|"~     In response to the European regulatory authorities, GSK is conducting a post-marketing~     observational study to assess the efficacy of Relenza when used as prophylaxis against~     influenza.~      SPECIFIC AIMS~        1. Determine the frequency of patients who received Relenza from October 2006 through April~          2009, and among them the number who have no concurrent diagnosis of influenza, i.e.,~          those receiving Relenza for prophylaxis, and among these the number who have a family~          member with a medical visit for influenza within three days preceding the above~          indentified patient's dispensing of Relenza. This is to determine the feasibility of~          conducting detailed analysis.~        2. If analysis is feasible then tabulate the frequency of influenza-like-illness and~          respiratory outcomes in users of prophylactic Relenza and their family members and in~          family members of persons using Relenza for the treatment of influenza (i.e., index~          cases).~        3. If analysis is feasible then estimate the direct effect of prophylactic Relenza on the~          occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of~          Relenza treatment of influenza on susceptible family members, and the total effect of~          Relenza (treatment plus prophylaxis).~      METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like~     illness and respiratory outcomes in persons for whom some household members (index cases)~     have had a medical visit associated with a diagnosis of influenza. The exposed individuals to~     the index case will be categorized into one of four cohorts according to whether the exposed~     person received prophylactic Relenza or no antiviral treatment and by whether the index~     family member with a diagnosis of influenza received antiviral treatment.~      Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing~     disease in susceptible family members, and the total effect of disease reduction when both~     index cases and susceptible family members are treated will be obtained from different~     comparisons between cohorts, as outlined below.~      The research will cover the first three influenza seasons during which Relenza has been~     indicated for prophylactic use in the United States. These will be from October through April~     of 2006-2009.~   "
184042|NCT01155817|"~     PRIMARY OBJECTIVES:~      Determine the safety and tolerability of nilotinib in steroid dependent / refractory cGVHD.~      SECONDARY OBJECTIVES:~      Determine the clinical efficacy of nilotinib in steroid dependent / refractory cGVHD.~   "
183976|NCT01156675|"~     The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™~     Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are~     suffering from lumbar spinal stenosis at one or two contiguous levels.~   "
183977|NCT01156662|"~     The present study was designed to investigate whether the thrombus aspiration using Export~     Aspiration Catheter (Medtronic Corporation, California, USA) during primary percutaneous~     coronary intervention (PCI) in acute myocardial infarction improve clinical outcomes.~   "
183978|NCT01156649|"~     Obstructive sleep apnea is a problem for a large number of children and can result in~     problems with thinking patterns, behaviors and sleep if left untreated. Little is known about~     how positive airway pressure (PAP) therapy might help children who need treatment for~     obstructive sleep apnea. We will investigate how PAP therapy might be able to improve~     thinking patterns, behavior and sleep problems in children with obstructive sleep apnea.~   "
183979|NCT01156636|"~     Prevalence of heart failure (HF) with left ventricular (LV) diastolic dysfunction and~     preserved ejection fraction (EF) (HFpEF) is increasing. Prognosis worsens with development of~     pulmonary vasoconstriction and hypertension (PH) and right ventricular (RV) failure. The~     investigators aimed at modulating pulmonary vascular tone and RV burden in HFpEF due to high~     blood pressure (HBP), by using the phosphodiesterase-5 (PDE5) inhibitor sildenafil.~   "
183980|NCT01156623|"~     In lung cancer with enlarged or non-enlarged mediastinal lymph nodes, contrast-enhanced~     computed tomography (CT) and Positron emission tomography (PET) scan frequently show~     discrepancy in tuberculosis-endemic area. Endobronchial ultrasound guided transbronchial~     aspiration (EBUS-TBNA) with ability of real-time nodal sampling possibly improves the nodal~     diagnosis.~      The purpose of this study is to compare the accuracy of nodal diagnosis of contrast-enhanced~     CT and PET scan with and without EBUS-TBNA, this study will be performed.~   "
183981|NCT01156610|"~     The objectives of this project are to develop and evaluate a multi-level approach to tobacco~     treatment for low-SES and minority patients. The components of this intervention would~     include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco~     treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and~     integration of this program with both an individual's primary care physician through an~     electronic health record (EHR), as well as referral to community resources to address the~     socio-contextual barriers to tobacco cessation. To achieve these objectives, this~     intervention will test an innovative model of systematic outreach to low-SES and minority~     smokers using systematic phone outreach (including cell phones which are particularly~     prevalent among minority and low-SES groups), coordinated with the PCP, using both a~     cost-effective technology and a dedicated tobacco treatment specialist to increase smoking~     cessation in these populations. The proposed intervention will have multiple levels of~     influence (patient, PCP) and provide linkages to community resources. If successful, this~     model could be generalized to other health systems with an EHR, which are increasingly being~     promoted to improve the safety and quality of health care.~      Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment~     program for low-SES and minority smokers can reach these patients to increase quit rates and~     use of tobacco treatment effectively.~      Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized~     treatment program for low-SES and minority smokers can be adopted across a variety of~     practice settings and be consistently implemented across diverse patient populations.~   "
183982|NCT01156597|"~     Metabolic defects contributing to the development of type 2 diabetes (T2D) are relative~     insulin insufficiency and insulin resistance that are associated with a cluster of~     abnormalities that increase the risk for cardiovascular disease including dyslipidemia,~     inflammation, hemodynamic changes and endothelial dysfunction. The dyslipidemia associated~     with T2D is characterized by elevated triglycerides and decreased high-density~     lipoprotein-cholesterol (HDL). The ability of the insulin sensitizing agent pioglitazone~     (ACTOS®) , to improve hyperglycemia in subjects with T2D is now well established.~     Pioglitazone functions as a PPAR-γ (peroxisome proliferator-activated receptor gamma)~     agonists and this class of drugs have demonstrated several other potential benefits, beyond~     glucose homeostasis. Specifically pioglitazone can improve diabetic dyslipidemia by~     increasing HDL cholesterol and lowing triglycerides. A potential beneficial effect on reverse~     cholesterol transport may be mediated by the increased HDL levels. This proposal aims to~     examine the effect of PPAR-γ activation by PIO on various aspects of reverse cholesterol~     transport by testing the hypothesis that PIO treatment affects key steps in the reverse~     cholesterol transport pathway either directly, through induction of protein expression, or~     indirectly, by altering HDL structure and composition leading to increase cholesterol flux~     through this pathway.~   "
183983|NCT01156584|"~     This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of~     increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to patients~     with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant~     radiation therapy and chemotherapy. Patients will receive Toca 511 either via stereotactic,~     transcranial injection into their tumor or as an intravenous injection given daily for 3 & 5~     days, depending on cohort. Approximately 3-4 weeks following injection of the RRV, treatment~     with Toca FC, an antifungal agent, will commence and will be repeated approximately every 6~     weeks until study completion. After completion of this study, all patients will be eligible~     for enrollment and encouraged to enter a long-term continuation protocol that enables~     additional Toca FC treatment cycles to be given, as well as permits the collection of~     long-term safety and survival data.~   "
183984|NCT01156571|"~     The study is designed to compare the efficacy and safety profile of cangrelor to standard of~     care in patients require percutaneous coronary intervention (PCI).~   "
183985|NCT01156558|"~     Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of~     severe bone loss by allowing rigid internal fixation and proper alignment of the extremity~     and components.~   "
183986|NCT01156545|"~     The investigators hypothesized that simvastatin may enhance sensitivity to BIBW 2992 in~     non-adenocarcinoma that is relatively resistant to TKIs. Based on these data, the~     investigators will research the effectiveness comparing BIBW2992, an irreversible EGFR-TKI,~     plus simvastatin with BIBW2992 alone in the setting of a randomized phase II study in~     previously treated patients with advanced non-adenocarcinomatous non-small cell lung cancer~     (NSCLC).~   "
183987|NCT01156532|"~     Adalimumab has recently been authorized for active psoriasis in Peru and local experience is~     very low. The aim of this study is to obtain Peruvian data of clinical effectiveness and~     impact on health-related quality of life with the use of adalimumab in participants with~     chronic plaque psoriasis complying with the dosing and monitoring recommendations of the~     local approved label.~   "
183988|NCT01156519|"~     The main objective of the study is to assess the sensitivity of the salivary cortisol dosage~     at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone~     suppression test (Suppression of serum cortisol <1.8 μg/dL ) as the reference method for the~     detection of ACIC in obese subjects~   "
183989|NCT01156506|"~     The study seeks to gain knowledge about new and of alternative ways of organizing ostomy~     training based on informants' own experiences of life with a stoma.~      The study is designed and conducted as qualitative focus group interviews with three~     different groups of patients with enterostomas (5-8 in each group): a) people with permanent~     enterostoma due to cancer, 2) people with permanent enterostoma due to non-cancer and 3)~     people with a temporary ileostomy.~   "
183990|NCT01156493|"~     Premature infants fed with a protein hydrolyzed formula will have better tolerance needing~     shorter time to achieve full feeds when compared to those fed with an intact protein formula.~   "
183991|NCT01156480|"~     Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant~     problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an~     inflammatory necrosis of the bowels, to date no study has examined the effect of~     anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators~     propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine~     the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The~     investigators will follow C-reactive protein (CRP) levels as a marker of systemic~     inflammation for the primary outcome in this study.~   "
183992|NCT01156467|"~     The purpose of this study is to find out, whether it is possible to improve the ventilatory~     care of premature infants by using Neurally adjusted ventilatory assist (NAVA).~      The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the~     electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature~     infants more individually.~   "
183993|NCT01156454|"~     X-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in~     their ability to identify the number and location of lymph nodes as well as more accurately~     section lymph nodes contained in surgical specimens.~   "
183994|NCT01156441|"~     The pilot prospective randomized trial is designed to determine the safety and feasibility of~     enrolling patients to surgically correct residual Mitral Regurgitation (MR) following~     Percutaneous Coronary Intervention (PCI) for Myocardial Infarction (MI) verses ongoing~     medical management of MR. The investigators hypothesize that if moderate MR is corrected in~     this patient subset, the patients will have improved outcomes as measured by decreased number~     of major adverse cardiac events, including death, congestive heart failure requiring~     hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA)~     functional status and improved quality of life.~   "
183995|NCT01156428|"~     This study will evaluate in patients with kidney disease, the role that certain inflammatory~     and immune mediators play in promoting kidney damage. The investigators hypothesize that~     certain mediators, (identified in the serum, urine and renal biopsy tissue), of patients with~     a variety of different renal disease states will provide information regarding their clinical~     course and that inflammatory and immune patterns in the serum and urine of patients with~     kidney disease may yield predictive diagnostic information in place of a renal biopsy. The~     ability to detect and quantify these mediators may lead to earlier detection and treatment of~     kidney disease in order to prevent kidney failure and the requirement for renal replacement.~      The study will evaluate serum, blood and urine collected over a one year period post kidney~     biopsy for the presence of inflammatory or immune mediators, which will be correlated with~     kidney pathology findings (gene signatures). These gene signatures will be compared to~     normal control specimens obtained from donor transplant kidneys or from normal kidney~     tissue obtained from patients who require their entire kidney removed for a tumor.~   "
183996|NCT01156415|"~     The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under~     the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder~     over a 52-week open-label phase.~      Cohort I is restricted to include patients who have completed a previous Novartis agomelatine~     (178C) Double-blind study.~      Cohort II will include de-novo patients (those who did not participate in a previous~     agomelatine 178C study) and will only be open for a limited time span ranging from~     approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.~   "
183997|NCT01156402|"~     The purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood~     obesity intervention with Hispanic families. The program aims at preventing childhood obesity~     by targeting parents to address nutrition, physical activity, and sedentary behaviors in~     their children.~   "
183998|NCT01156389|"~     Pyronaridine/ artesunate (Pyramax) is an antimalarial therapy which has been demonstrated to~     be a safe and effective treatment in patients with Plasmodium falciparum and vivax malaria.~      This drug interaction study is intended to investigate if there is any interaction between~     Pyramax and the protease inhibitor ritonavir in healthy subjects using ritonavir as a probe~     substrate.~   "
183999|NCT01156376|"~     This study is 25 days long. People participating in this study will be asked to brush their~     teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day~     at the site for five days. A dentist or dental hygienist will look at the mouth, teeth,~     tongue and gums to make sure the mouthwash does not irritate the mouth. After Day 5 of the~     study, people will continue to brush two times a day and will return on Day 24 to have their~     mouth looked at again. People without irritation in their mouth will rinse 4 times a day at~     the clinical site. People will return to the clinical site the next day and have a final oral~     exam in which the dentist or dental hygienist will look at the mouth for irritation.~   "
184073|NCT01155414|"~     The primary objective of this study is to assess the comparative gastrointestinal (GI)~     tolerance of normal term infants to two experimental powdered formulas compared with a~     commercially available powdered formula.~   "
184000|NCT01156363|"~     This open label, single arm study will assess the efficacy for long-term maintenance of~     haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin~     beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term~     haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera~     for 6 months. Target sample size is <200 patients.~   "
184001|NCT01156350|"~     To date, no curative option exists for patients with relapsed or refractory stage IV~     neuroblastoma after previous autologous stem cell transplantation. Our preliminary results of~     RIC allo-HSCT (protocol RICE) indicate the feasability and low toxicity of allograft in~     heavily pre-treated children. Furthermore RIC SCT and immunomagnetic CD3/CD19 graft depletion~     may allow HHCT with lower toxicity and faster engraftment. CD3/CD19 depleted grafts not only~     contain CD34+ stem cells but also graft-facilitating cells, CD34- progenitors, dendritic and~     natural killer cells which may allow stable engraftment and participate to GvT effect.~      After haploidentical stem cell transplantation anti tumour activity exerted by donor derived~     NK cells could be stimulated by NK cells injections. Those effects may help to reduce the~     relapse rate and to impove the outcome of those patients. The investigators prospectively~     evaluated engraftment and immune reconstitution.~   "
184002|NCT01156337|"~     The study was aimed to verify the effects of Hypertonic saline solution (HSS) and a moderate~     sodium (Na) restriction plus high furosemide dose in the short term (hospitalization time)~     and a moderate Na restriction in the long term on readmissions and mortality in patients in~     III NYHA class.~   "
184003|NCT01156324|"~     The goal of this study is to determine the impact of an online stress management program,~     which combines stress reduction and prevention strategies with personal care products/rituals~     which have relaxation properties, on pregnancy rates and psychological distress in women~     undergoing IVF for the first time.~   "
184004|NCT01156311|"~     The primary objective of the study is to evaluate the safety and tolerability of BG00012~     (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer~     acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).~   "
184005|NCT01156298|"~     Phase IV, multi-center, non-treatment, observational, registry study to determine long term~     effects of AVONEX® therapy on EDSS, MRI, QoL, and cognition.~   "
184006|NCT01156285|"~     Acute anterior uveitis (AU) is a common reason for attendance at ophthalmic outpatient~     clinics. The painfulness and the fear of a transient or even persistent loss of vision may~     markedly reduce the individual's subjective well-being and pose a psychological burden.~      This study will test the hypothesis that during an attack of AU the patient experiences a~     marked reduction in psychological and physical well-being.~      Prospective, hospital-based epidemiologic study using a patient questionnaire with~     standardized psychological tests and a pain scale.~   "
184007|NCT01156272|"~     The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic~     Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population~     undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement~     of a failed prosthesis.~   "
184008|NCT01156259|"~     The purpose of this study is to determine whether 30Gy Involved-field Radiotherapy (IFRT) is~     as effective as 40Gy in the treatment of localized Diffused Large B cell Lymphoma (DLBCL)~     when completing CR after chemotherapy.~   "
184009|NCT01156246|"~     The purpose of this study is to determine whether treatment with a fixed dose combination~     dapagliflozin/metformin tablet is affected by food.~   "
184010|NCT01156233|"~     In pediatric anesthesia it is very important to place the endotracheal tube into the right~     position. This study compares two clinical location methods. The hypothesis means that the~     two techniques have the same precision of the location of the tip position of a cuffed~     MICROCUFF (Kimberly-Clark)endotracheal tube.~   "
184011|NCT01156220|"~     In this study the gender specificity of the effects of furosemide in female and male~     volunteers will be investigated. The healthy volunteers receive 1. furosemide and 2.~     aminohippurate sodium PAH as single dose. The main objective is gender-specific comparison~     of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide~     (urinary excretion). Secondary objectives are the gender-specific comparison of renal and~     systemic PAH clearance with the clearance of furosemide and the influence of various genetic~     polymorphisms on the variability of furosemide pharmacokinetics.~   "
184012|NCT01156207|"~     Heart failure is a major health problem worldwide. Optimal treatment of this disabling and~     fatal condition may require functional characterization of the failed left ventricle (LV) and~     its interaction with the arterial system. Part of the physiological significance of the~     ventriculo-arterial coupling has been studied experimentally and clinically using the~     framework of the ratio of effective arterial elastance (Ea) to end-systolic elastance (Ees),~     with limited clinical applications.~      From central ascending aorta to terminal arterioles, every segment of the arterial tree~     contributes to the arterial loads that interact and impact LV performance in both systole and~     diastole, leads to atrial and ventricular remodeling and hypertrophy, and results in the~     development of heart failure. On the other hand, the ventricular systole is a complex~     coordination of multi-directional myocardial fibers involving longitudinal contraction,~     circumferential shortening, radial thickening, twist, and torsion, the so-called LV~     deformations.~      The purposes of the present study are to investigate the relationship between different~     components of hemodynamic load or arterial abnormalities and different components of LV~     myocardial deformations or regional LV function, the modulating effects of endothelial~     progenitor cells (EPCs) on the ventriculo-arterial coupling, and the therapeutic effects of~     aliskiren on the components of hemodynamic load and LV myocardial deformations and their~     couplings. The investigators will also investigate whether the ventriculo-arterial coupling,~     EPCs, and add-on therapy of aliskiren predict cardiovascular outcomes.~   "
184013|NCT01156194|"~     The homeopathic remedy consisting of Arnica and Bellis perennis have been shown in a previous~     pilot study (n=33) to reduce blood loss during the third stage of delivery, when compared~     with placebo treatment. The purpose of this study is to repeat the previous methodology, this~     time on a larger population.~      210 parturients will be randomized to one of three groups: Arnica montana C6 and Bellis~     perennis C6 (n=70), Arnica montana C30 and Bellis perennis C30 (n=70), or double placebo~     (n=70).~   "
184014|NCT01156181|"~     Pregnancy rate may be affected by multiple factors such as embryo transfer techniques. Even~     small differences in embryo transfer methods may affect pregnancy rates. There is an~     inconsistency about the effect of the removal of cervical discharge on embryo transfer~     outcomes. Some studies showed that cervical mucus removal before embryo transfer can increase~     pregnancy rate, however the others could not find any significant effect about the removal of~     cervical mucus on pregnancy or live birth rates. Given to the conflicting evidences, our~     study aimed to determine whether the cervical discharge removal has positive effect on~     pregnancy rate.~   "
184015|NCT01156168|"~     RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will~     respond to treatment.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     breast cancer treated with bevacizumab.~   "
184016|NCT01156155|"~     Periodontitis (PD) has been postulated to be a risk factor for the onset and progression of~     rheumatoid arthritis (RA). Recent reports suggest that infection with Porphyromonas~     gingivalis (P. gingivalis), a major oral pathogen in PD, could play a pivotal role in the~     development RA. The objective of this study is to examine the relationship of PD and P.~     gingivalis infection with the risk and severity of RA.~   "
184017|NCT01156142|"~     RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in~     patients undergoing radiation therapy with or without chemotherapy.~      PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it~     works compared to placebo in treating oral mucositis pain in patients with head and neck~     cancer undergoing radiation therapy with or without chemotherapy.~   "
184018|NCT01156129|"~     This is a randomized controlled trial to assess ways to address post-operative ileus (POI) in~     adult patients on the liver transplant service undergoing either liver transplant or~     resection surgery. Patient who speak and understand English will be randomized into one of~     three groups including a.)control group receiving standard therapy for post-operative ileus,~     b.)group receiving standard therapy and acupressure bracelets, and c.)group receiving~     standard therapy and sugar free gum four times daily.~   "
184019|NCT01156116|"~     Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and~     diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure~     (CPAP) has metabolic benefits. The objective of this study is to determine the effect of~     8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.~   "
184020|NCT01156103|"~     This study will assess the impact of a national, community-based after-school program~     promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular~     risk factors among minority children. The investigators central hypothesis is that~     established community-based programs, such as America SCORES, can reduce obesity and~     cardiovascular risk among participants. The 1-year study followed 158 children from 6 public~     schools, 3 of which were randomized to have SCORES and 3 to usual care after-school~     program. Primary outcomes are change in body mass index (BMI), physical activity (measured by~     accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test).~     Cardiovascular outcomes include blood pressure, body composition (assessed using~     bioelectrical impedance) and waist circumference. The investigators will also measure~     academic outcomes.~   "
184021|NCT01156090|"~     The purpose of this study is to identify approximately 100 - 150 patients who have received~     Vectibix (Panitumumab) in offices and clinics located in Tennessee, North Carolina, South~     Carolina, and North Georgia from February 2004 - April 2009. Information regarding the~     incidence and severity of hypersensitivity infusion reactions to Vectibix (Panitumumab)will~     be captured. In patients who experienced hypersensitivity reactions, the following~     information will also be collected: premedication, treatment cycle symptoms that were~     experienced during chemotherapy, changes required in subsequent Vectibix (Panitumumab) or~     chemotherapy treatment, and outcome of the hypersensitivity reaction.~   "
184022|NCT01156077|"~     This is an open-label, multi-center, two-part, parallel-design study to assess the PK,~     safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single~     oral dose (Part A) or IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent patients.~   "
184023|NCT01156064|"~     Confocal laser endomicroscopy (CLE) is a newly endoscopic device that enables microscopic~     view of the digestive tract. The purpose of this study is to determine if confocal laser~     endomicroscopy can improve detection of digestive disease include inflammation, dysplasia,~     and early cancer, and if confocal laser endomicroscopy has competitive advantage, compared~     with other device such as Narrow Band Imaging and Autofluoresecence Imaging.~   "
184024|NCT01156051|"~     This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if~     guanfacine extended release is able to improve nighttime sleep in children with ADHD -~     associated insomnia while improving daytime ADHD symptoms. Male and female children with~     diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty~     staying asleep, or less than expected hours of sleep) will be recruited. After obtaining~     informed consent and assent (when appropriate) and after discontinuation of excluded~     medications, children will have evaluations of his or her sleep and evaluations confirming~     the ADHD diagnosis. Children who successfully pass screening will be enrolled into the~     double-blind, placebo-controlled, randomized investigation with 50% of participants receiving~     guanfacine extended release and 50% of participants receiving matching placebo. Using a~     flexible-dose optimization design based on ADHD symptom improvement and medication~     tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At~     the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires,~     and sleep tests will be repeated and analyzed. The medication will be weaned over the course~     of the following 3-10 days.~   "
184025|NCT01156038|"~     Atopy patch test in normal population~   "
184026|NCT01156025|"~     The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to~     placebo in patients with acute adenoviral keratoconjuncivitis.~   "
184027|NCT01156012|"~     The purpose of this study is to assess the efficacy and safety of T2345 versus active~     comparator.~   "
184028|NCT01155999|"~     Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent~     bacterial conjunctivitis of children.~   "
184029|NCT01155986|"~     The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated~     plaster in localized chronic post-operative neuropathic pain in comparison to placebo~     plaster.~   "
184030|NCT01155973|"~     Background: High blood pressure (HBP) is a major risk factor for cardiovascular disease~     (CVD). European hypertension and cardiology societies as well as expert committees on CVD~     prevention recommend stratifying cardiovascular risk (CVR) using the SCORE method, the~     modification of lifestyles to prevent CVD, and achieving good control over risk factors. The~     EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of~     a CVR visual learning method - the EDUCORE method - is more effective than normal clinical~     practice in improving the control of blood pressure within one year in patients with poorly~     controlled hypertension but no background of CVD.~      Design & Method: Cluster randomized controlled clinical trial. Location: 22 primary health~     care centres in Madrid. Participants: patients diagnosed as hypertensive (systolic >140 mmHg~     and/or diastolic >90 mmHg) at least a year before, uncontrolled. Age: 40-65 year-old patients~     who consent to take part. Sampling: randomized cluster assignment. Random allocation unit:~     health care centre. Analysis unit: patient who match criteria. Size: 736 patients (368 each~     arm. Measurements: Outcome variables: systolic and diastolic blood pressure (mmHg).~     Cardiovascular risk level: SCORE. Measure of Adherence to treatment (Morisky-Green~     questionnaire. Health related quality of life questionnaire MINICHAL. Smoking habits. Total~     Cholesterol. Other variables: Gender. Age. Educational level. Physical activity in metabolic~     equivalent (MET). Body mass index. Drug consume (cardiovascular line). Treatment changes and~     nature of the change. Intervention: EDUCORE group (direct exhibition of their cardiovascular~     risk with SCORE, visual images and documentation to the patients); Control Group: standard~     practice care.~   "
184031|NCT01155960|"~     The purpose of this study is to compare bioavailability in healthy, post menopausal women~     subjects under fed conditions.~   "
184032|NCT01155947|"~     The purpose of this study is to compare bioavailability in healthy, post menopausal women~     subjects under fasting conditions.~   "
184033|NCT01155934|"~     The purpose of this study was to assess the single-dose relative bioavailability study of 1~     mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fed conditions.~   "
184034|NCT01155921|"~     The purpose of this study was to assess the single-dose relative bioavailability study of 1~     mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fasting conditions.~   "
184035|NCT01155908|"~     The objective of this study was to compare the single-dose relative bioavailability of Dr.~     Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril~     hydrochloride capsules, under non-fasting (fed) conditions.~   "
184036|NCT01155895|"~     The objective of this study was to compare the single-dose relative bioavailability of Dr.~     Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril~     hydrochloride capsules, under fasting conditions.~   "
184037|NCT01155882|"~     The purpose of this study is to determine how effective Whipple at the Splenic Artery~     (WATSA).~   "
184038|NCT01155869|"~     Almost 200,000 veterans are homeless each night, about one-quarter to one-third of homeless~     adults in the U.S. Half need treatment for a substance use disorder, usually alcohol~     dependence, but sobriety is often required to access alcohol treatment and housing services.~     A monthly injection of depot naltrexone is efficacious in reducing alcohol use, but it is~     expensive and restricted in many VA Medical Centers. Oral naltrexone is more available but~     seldom used because of adherence problems that limit effectiveness. This open-label pilot~     study would compare the effect of depot versus oral naltrexone to help twenty homeless,~     alcohol-dependent veterans decrease their drinking, achieve sobriety and qualify for housing~     services. This study's findings could expand access to effective medication-assisted alcohol~     treatment in the VA, and thus help homeless veterans with alcohol problems improve their~     drinking, housing status, and appropriate use of health services.~   "
184039|NCT01155856|"~     Introduction:~      With the rapid development in technology telemedicine has become a tool with the potential to~     improve and optimize the treatment of different diseases and to make diagnostics, treatment~     and counseling possible over shorter or longer distances.~      Home based telemedicine is a new method that leads to a series of important questions that~     needs to be answered. This study is designed to answer questions concerning patient safety in~     telehomecare, the patients´ quality of life, efficiency and a cost benefit analysis of~     implementing this technology.~      This study is about patients with chronic obstructive pulmonary disease (COPD) who are~     admitted to the hospital with an acute exacerbation. Approximately 24 hours after admission~     half of the patients are randomized to be admitted to their own home supported by telemedical~     equipment while the other half remain admitted at the hospital (typically between 5-7 days).~      Primary Aim:~      To investigate if telemedical surveillance and treatment in the recovery period of an acute~     exacerbation is just as safe as conventional admission of patients with COPD measured on~     treatment failure.~      Secondary Aims:~      To evaluate if telemedical surveillance and treatment in the recovery period of an acute~     exacerbation compared to conventional treatment of COPD:~        1. Is comparable in reestablishing Forced Expiratory Volume in 1 second (FEV1).~        2. Demands the same number of treatment days/time before discharge/cessation of telemedical~          surveillance.~        3. Is comparable in quality of life in the two groups of treated patients.~        4. Have comparable adverse event profiles.~        5. leads to a lower total cost in health services (health economical analysis)~        6. Is possible to do for the patients (drop-outs because of the technical equipment or the~          patient does not know how to use the equipment.)~      7 Is better seen from the physician's perspective when it comes to:~        1. The virtual patient contact / communication~        2. Technology~        3. The work process compared to the conventional work process~        4. Time spent with the patient~        5. Usability~        6. Improvement potentials (the doctors view)~           8. The equipment is satisfactory for the patient to use~           Method~           For this study a telemedical platform has been developed on which it is possible to~          treat patients in their own homes. The platform consists of a videoconference part that~          allows the patients to make contact to qualified medical staff and a technology part~          that can transfer vital indicators of the patients´ health condition (lung function,~          oxygen saturation, pulse etc.) 175 patients will be included with an expected drop-out~          of 20 % or 35 patients. The patients will be equally recruited from two hospitals~          (Frederiksberg and Herlev Hospital). All patients must have an exacerbation in their~          COPD that requires hospitalization to be included in this study. Each patient~          participates in the study for 6 months after discharge with follow-up at 1, 3 and 6~          months.~   "
184040|NCT01155843|"~     Asthma is a chronic disease that affects nearly 13% of adults in the U.S., causing~     substantial impairment that is reflected in the tens of millions of missed days of work, and~     doctors' and emergency room visits it leads to annually. Those who have asthma are twice as~     likely to develop depression and anxiety, which are associated with more frequent and severe~     asthma symptoms, especially in those under chronic stress. The project proposed here seeks to~     understand the role of the brain in these associations and to evaluate the neural mechanisms~     through which a safe, low-cost intervention, that influences the function of body via the~     mind, may diminish the expression of asthma symptoms.~   "
184041|NCT01155830|"~     This study proposes to quantify inflammatory cytokine profiles in three neonatal disease~     states, namely, neonatal sepsis, infants with a congenital diaphragmatic hernia defect, and~     infants suffering cardiopulmonary failure significant enough to require heart/lung bypass~     treatment with extracorporeal membrane oxygenation (ECMO).~   "
184043|NCT01155804|"~     Introduction: randomized studies on programs implemented during pre-natal care that offer~     information and physical activities preparing pregnant women for delivery are scarce in the~     scientific literature. Objective: to evaluate the effectively of the Program for Preparation~     of Pregnant Women for Delivery on the prevention of physical and psychological difficulties~     and problems during pregnancy and delivery in nulliparous women participating in the program.~     Subjects and methods: a randomized clinical single blind trial will be conducted with 192~     pregnant nulliparous women allocated to participate or not of the program activities. The~     women allocated to the study group will participate of physical and educational activities at~     each pre-natal consultation and will receive orientation on the exercises they will perform~     at their home. Participants of the non-interventional group will follow the habitual routine~     care at the service. Participants will be selected among nulliparous low risk pregnant women~     aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be~     performing by intention to treat. For the continues variables the t-Student or Wilcoxon test~     will be performing; for the categorical variables the tests x² or Fisher, and the risk~     estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures~     between the groups and along time, and correlation tests for anxiety and physical activity~     with gestational and perinatal variables.~   "
184044|NCT01155791|"~     Selenium, in the form of inorganic Sodium Selenite, may be useful for treating existing~     prostate cancer. This idea is based on data from our laboratory showing that 1) prostate~     cancer cells are more sensitive to Selenium (Sodium Selenite)-induced apoptosis than normal~     prostate epithelial cells, 2) Selenite induces significant growth inhibition of well~     established prostate cancer tumors in mice at doses that have no detectable toxicity, and 3)~     Selenite disrupts AR signaling, and that the inhibition of AR expression and activity by~     Selenite occurs via a redox mechanism involving GSH, superoxide, and Sp1. Altogether, these~     findings suggest that Selenium may be useful in a variety of potential indications in the~     natural history of prostate cancer, including both hormone sensitive and castrate resistant~     prostate cancer, as a single agent, or in combination with radiation, chemotherapy or~     conventional hormone therapy. Selenite is a potential novel inhibitor of AR expression and~     function in prostate cancer.~   "
184045|NCT01155778|"~     Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease~     (LSD) caused by loss in activity of 1 of 4 enzymes necessary for degradation of the~     glycosaminoglycan (GAG) heparan sulfate (HS) in lysosomes. The central nervous system (CNS)~     is the most severely affected organ system in patients with MPS IIIA. In these patients~     abnormal behaviors include, but are not limited to, aggression and excess motor~     activity/hyperactivity that contribute to disturbances in sleep.Overall, individuals with MPS~     IIIA have a marked developmental delay and significantly reduced lifespan of 15 years of age~     on average.~      The purpose of this study is to determine the safety and tolerability of rhHNS via ascending~     doses administered via an a surgically implanted intrathecal drug delivery device (IDDD)~     intrathecal (IT) route once monthly for 6 months in patients with MPS IIIA.~   "
184046|NCT01155765|"~     Clopidogrel administration is essential in patients undergoing percutaneous coronary~     intervention, in patients with previous stroke, in patients under chronic hemodialysis via~     fistulae and in patients with chronic atrial fibrillation if coumarin administration is not a~     viable option. Patients with chronic renal failure present lower clopidogrel response~     compared to those with normal renal function. Additionally, hemodialysis via the dialysis~     filter causes a decrease in glycoprotein platelet receptors, potentially associated with~     thienopyridine hyporesponsiveness. Clopidogrel resistant patients as assessed by VerifyNow~     P2Y12(Accumetrics)will be randomized in 1:1 fashion to prasugrel 10mg/day or clopidogrel~     150mg/day. On day 15±2 days a crossover directly to the alternate treatment group will be~     carried out, without an interventing washout period. All patients will undergo platelet~     reactivity assessment, documentation of major adverse cardiac events and documentation of any~     serious adverse events(stroke, bleeding)at day 15 and day 30.~   "
184047|NCT01155752|"~     The hypothesis is that the intranasal use of Pulmozyme will decrease the severity of~     sinusitis in Cystic Fibrosis and lead to an improved quality of life.~   "
184048|NCT01155739|"~     Procalcitonin level used for determining length of antibiotic treatment in peritonitis and~     intra-abdominal infections. Hypothesis is that length of antibiotic use can be shortened by~     this method.~   "
184049|NCT01155726|"~     The purpose of this study is to explore the effect of masking on subjective ratings for two~     daily disposable contact lenses.~   "
184050|NCT01155713|"~     This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and~     the effect of food on the bioavailability of TKI258, in adult patients with advanced solid~     tumor.~   "
184051|NCT01155700|"~     The primary purpose of this study is to examine whether the geometric mean of serum free IgE~     level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of~     age) reaches under 25 ng/mL (target level). The investigators will also assess how well PK/PD~     data of Japanese children fit the global PK-PD modeling built from those of Caucasian adults~     and children, and assess efficacy and safety data in Japanese pediatric patients which will~     fulfill the Japanese health authority requirement for approval. Data obtained from the study~     is intended to be used to support the registration of pediatric indication of omalizumab in~     Japan.~   "
184052|NCT01155687|"~     The assessment intends to investigate the efficacy of psychosocial counseling for the~     treatment of help seeking individuals with psychosocial problems in Mazar-e-Sharif,~     Afghanistan. Treatment was administered by local counselors who had received specific~     education and training~   "
184074|NCT01155401|"~     The purpose of this study is to determine and analyse the incidence, severity, risk factors~     and routine management of acute drug-induced upper gastrointestinal bleeding (UGIB) in the~     population of Russian patients~   "
184075|NCT01155388|"~     Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral~     iron for the treatment of pediatric participants with chronic kidney disease (CKD).~   "
184076|NCT01155375|"~     Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral~     iron for the treatment of pediatric participants with chronic kidney disease (CKD).~   "
191655|NCT01055717|"~     This is a placebo-controlled, crossover study investigating the pharmacokinetic~     bioavailability of avenanthramides from avenanthramide-enriched oats and their in vivo~     metabolites in a cohort of healthy, older adults.~   "
184053|NCT01155674|"~     Polymorphonuclear neutrophils, or granulocytes, are essential effector cells of the innate~     immune system against bacterial infections. Their role in sepsis has been long established as~     the primary phagocyte to clear the infectious process. In the early phase of sepsis, one~     observes a massive recruitment of immature neutrophils from the bone marrow into peripheral~     blood, the so-called band forms or left shift cells. Despite the daily clinical use of~     neutrophil band forms count in the care of septic patients and their abundance in septic~     blood, no information exists on the fate of these cells, nor on their capacity to mount an~     efficient innate immune response. It is the goal of this proposal to study the fate and the~     innate immune functions of immature neutrophils obtained in patients with early septic shock.~     Immature neutrophils will be separated from mature neutrophils. The following functions will~     be studied ex vivo in mature vs. immature neutrophils from a series of patients with severe~     sepsis and septic shock: (1) surface expression of receptors of the innate immunity; (2)~     production of inflammatory mediators and reactive oxygen species in response to bacterial~     agonists; (3) chemotaxis; (4) phagocytosis of Gram-positive and Gram-negative bacteria; and~     (5) ex vivo viability (life span) and resistance to apoptosis. Importantly, the investigators~     have developed and mastered all in vitro assays and cell separation techniques necessary to~     address and answer these important questions. This project will undoubtedly shed light on the~     fate and function of a prominent leukocyte population circulating in patients with severe~     bacterial infections and sepsis.~   "
184054|NCT01155661|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin~     reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major~     depressive disorder (MDD) who are partial responders to their SSRI treatment.~   "
184055|NCT01155648|"~     The purpose of this study is to compare two physiotherapy techniques: chest wall compression~     versus chest wall compression plus increase of 10 cmH2O in inspiratory pressure.~   "
184056|NCT01155635|"~     The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year~     clinical outcomes in patients with ST-segment elevation acute myocardial infarction and~     preserved left ventricular ejection fraction after primary percutaneous coronary~     intervention.~   "
184057|NCT01155622|"~     Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in~     patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is~     suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose~     of this study is to determine whether different temperature targets (32º vs 34º) may have~     different efficacy in the treatment of post-cardiac arrest patients. If successful, this~     pilot study will eventually form the basis for a larger, multicentric randomized clinical~     trial.~   "
184058|NCT01155609|"~     This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing~     radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen~     the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with~     or without chemotherapy for head and neck cancer~   "
184059|NCT01155596|"~     This is a Quasi-experimental research design. The subjects are limited in intensive care unit~     within north medical center hospital. All subjects depend on ventilator and receive weaning~     plans. Experimental group is weaning with the support of negative pressure ventilator .The~     investigators collect basic personal variables in the questionnaire, APACHE Ⅱ scale, Dyspnea~     scale and arterial blood gas analysis and ventilator weaning index. Compare experimental~     group and control group data. Data will be Statistical analyzed by: descriptive statistics~     (such as: mean, standard deviation, median, frequency, percentage) and inferential statistics~     (such as: Independent T-test, Pair T-test, Mann-Whitney U test), P-value <0.05 will consider~     to be statistically significant.~   "
184060|NCT01155583|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine and dexamethasone, work in~     different ways to stop the growth of cancer cells either by killing the cells or by stopping~     them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune~     system in different ways and stop cancer cells from growing. Giving azacitidine together with~     lenalidomide and dexamethasone may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of azacitidine when~     given together with lenalidomide and low-dose dexamethasone in treating patients with~     relapsed or refractory multiple myeloma.~   "
184061|NCT01155570|"~     The survey will be conducted with regard to the following aspects of treatment with Humira~     (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug:~        -  unknown adverse drug reactions, especially clinically significant adverse reactions~        -  incidence and conditions of occurrence of adverse reactions in the clinical setting~        -  factors that may affect the safety and effectiveness of Humira.~   "
184062|NCT01155557|"~     This study aims at examining muscle strength capacity in neck and shoulder muscles in~     children and adolescents with and without tension-type headache, and furthermore examining~     the effect of a 10 week specific strength training programme for neck and shoulder muscles~     compared to a multi-disciplinary approach in 10 weeks.~   "
184063|NCT01155544|"~     This project focuses on the under-researched group of individuals who develop psychotic~     episodes of short duration (less than four weeks) while using substances. This includes~     individuals diagnosed with psychotic disorder not otherwise specified (PNOS) or~     substance-induced psychotic disorder (SIP) AND substance abuse or dependence. Very little is~     known about the most appropriate maintenance/relapse prevention management of these subjects.~     These individuals are not diagnosed with a primary psychosis because psychotic symptoms are~     too short-lived or non-specific, the onset of substance use precedes the onset of psychotic~     symptoms and the subject has not experienced sufficient psychotic symptoms in the absence of~     substance use. However, previous studies have shown that they are at high risk of recurrence~     of psychotic symptoms. Thus, this project will assess the efficacy of the second-generation~     antipsychotic aripiprazole for maintenance treatment of subjects who had a recent psychotic~     episode of short duration associated with substance use. The investigators will compare~     aripiprazole and placebo for preventing the recurrence of psychotic symptoms and decreasing~     substance use during a 6-month maintenance phase.~   "
184098|NCT01155089|"~     The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fed~     conditions~   "
184064|NCT01155531|"~     The hypothesis of this study is that up to 150 mg of sertraline and up to 3 mg of telenzepine~     will be safe, tolerable, and have the effect of suppressing appetite, when taken in~     combination daily by mouth by healthy, overweight, adult men and women.~      In this study, up to 12 people will be assigned to one of 4 groups: A, B, C, and D, and will~     receive 0, 50, 100, or 150 mg of sertraline per day. People in Groups B, C, or D will receive~     an initial dose of 50 mg sertraline. People in Groups C and D will receive an additional 50~     mg of sertraline per week.~      Up to 10 people from each group who were able to tolerate their sertraline dose for at least~     5 days will begin taking 50 mg of sertraline plus doses of telenzepine that will increase~     from 1 mg to 2 mg to 3 mg over a 7-day period (they will receive each combination). On the~     day before they begin taking this combination of drugs, their appetite will be evaluated (on~     a visual scale of 0 to 100) before and after 3 meals.~      The appetites of each person, assessed by the visual scale, will be evaluated on the last day~     of the period (Day 7) before and after 3 meals of each combination treatment, while they are~     staying in the research unit. The amount of food they eat will be determined.~      Based on safety and tolerability assessments of individuals, and of the previous groups who~     received lower doses of the combination of drug, a decision will be made whether to further~     increase the dose of these drugs.~      Since the appetites of each person will be evaluated on the last day of the period (Day 7)~     before and after 3 meals of each combination treatment, people in this study will stay in the~     research unit for approximately 2½ days, starting on Day 6 of their previous treatment, so~     appetite evaluations can be made on Day 7 after a fixed meal in the evening of Day 6. These~     people will continue the stay in the research unit when they begin each telenzepine dose~     increase, so a 24 hour safety observation may be made immediately after the increase.~      After the final doses of telenzepine have been received, people in Groups C and D will~     continue to receive sertraline 50 mg per day for an additional 7 days or until the study~     physician decides when sertraline should be discontinued. People will return to the study~     unit for final visit, 2 weeks after they have received their last sertraline dose.~   "
184065|NCT01155518|"~     Low testosterone production, known clinically as hypogonadism, appears to be common~     complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known~     to be associated with decreased muscle mass, increased fat mass, increased inflammation and~     decreased fertility. In this grant, the investigators propose to study the effects of having~     low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat~     and muscle mass at specific areas of the body 3) expression of mediators of inflammation in~     the blood 4) semen quality. This study will compare diabetic men (with or without~     hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug~     that increases testosterone and sperm production) or testosterone in men with diabetes and~     hypogonadism. The investigators hope that this project will help us understand the state of~     hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us~     insights into treatment of this condition. With the rising prevalence of type 2 diabetes in~     the young, this project may have implications for public health.~   "
184066|NCT01155505|"~     This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the~     maximum Tolerated Dose (MTD) of the combination of CC-5013 (Lenalidomide)and paclitaxel in~     patients with advanced solid tumors.~      Other purposes of the study are:~        1. Define the safety profile of the CC-5013 and paclitaxel given in combination~        2. Define the pharmacokinetics of CC-5013 and paclitaxel given in combination~        3. Define the pharmacodynamic effects of the combination by monitoring potential biomarkers~          of the different biological activities of each component of the regimen~        4. Define the optimal biological dose (OBD) and the dose recommended (RD) for phase II~          studies in selected tumor types (breast, ovary, prostate, NSCLC)~        5. Collect evidence of antitumor activity in selected tumor types~   "
184067|NCT01155492|"~     The gut may be a portal of entry for agents that cause or contribute to the causes of~     Parkinson's disease (PD). The investigators are studying changes in the normal population of~     gut flora and in intestinal permeability and their associations with early PD.~   "
184068|NCT01155479|"~     This is a one year, 2-part study to determine the efficacy and safety of preladenant, an~     adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to~     determine if preladenant is effective in the treatment of early Parkinson's Disease. The~     purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well~     tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of~     preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the~     sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).~   "
184069|NCT01155466|"~     When a patient with Parkinson's disease (PD) is initially treated with L-dopa or dopamine~     agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or~     dopamine agonists, patients notice that their PD medications wear off sooner than when they~     first started taking them. This wearing off is characterized by the return of symptoms~     (i.e., tremor, slowness, and rigidity) and may occur over the course of a few minutes to an~     hour. When a patient's PD symptoms have returned, the patient is said to be in the off~     state. When the patient takes another dose of medication, and his/her PD symptoms improve or~     resolve, the patient is said to be in the on state. Antagonism of adenosine Type 2a~     receptors (A2a) may provide relief of PD symptoms. This trial will test the hypothesis that~     A2a receptor antagonism can lead to improvement in the function of PD participants taking a~     stable dose of L-dopa, as measured by a reduction in off time.~   "
184070|NCT01155453|"~     This is an open label, dose finding, phase Ib clinical trial to determine the maximum~     tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K~     (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given in combination with the MEK inhibitor~     GSK1120212 in patients with selected, advanced solid tumors. The focus will be on tumors with~     RAS/RAF mutations and on triple negative breast cancer.~      Both study drugs will be administered once daily orally on a continuous schedule, a treatment~     cycle is defined as 28 days.~      Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set~     will be enrolled per dose combination below the MTD. The MTD is defined as the highest drug~     dosage not causing in the first cycle of treatment medically unacceptable, dose-limiting~     toxicity (DLT) in more than 33% of the treated patients.. At least 12 patients will be~     required at MTD and 6 patients at RP2D level to allow the evaluation of the combination's~     safety and pharmacokinetics or pharmacodynamics.~      Upon declaration of MTD and/or RP2D, patients will be enrolled to an expansion part of the~     study, to further assess safety, as well as to learn more about the efficacy of the study~     drug combination.~        -  Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant~          advanced NSCLC~        -  Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant~          ovarian cancer~        -  Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant~          pancreatic cancer~   "
184071|NCT01155440|"~     Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel~     movement will be faster and decrease pain intensity, opioid consumption and side effects,~     length of hospital stay; probably as a result of a significant opioid sparing and attenuated~     inflammatory response.~   "
184072|NCT01155427|"~     The purpose of this study is to support the clinical value of entecavir by assessing the~     relationship between viral load and histological improvement.~   "
184077|NCT01155362|"~     The primary objective of the study is to estimate the treatment effect of 3 different doses~     of PDA001 versus placebo in subjects with moderate-to-severe Crohn's Disease. The secondary~     objective of the study is to assess the safety and tolerability of PDA001 versus placebo in~     the above-mentioned patient population.~   "
184078|NCT01155349|"~     The purpose of this study is to examine the feasibility and potential effectiveness of a~     cognitive training program among persons with Parkinson's disease. It is hypothesized that~     individuals with PD will be able to complete and benefit from the intervention.~   "
184079|NCT01155336|"~     This study will explore the safety and effectiveness of adding Lovaza® to the therapeutic~     program utilized internationally for the treatment of individuals with acute coronary~     syndromes.~   "
184080|NCT01155323|"~     This study seeks to evaluate and compare the clinical performance of two daily disposable~     soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.~   "
184081|NCT01155310|"~     The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2)~     78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate~     and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive~     Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.~   "
184082|NCT01155297|"~     Introduction: Chronic Kidney Disease (CKD) is considered an important public health problem,~     with prevalence of 9.6% in our population. The CKD has as main symptoms fatigue, muscle~     weakness and poor exercise tolerance, which directly contribute to physical inactivity and~     low mobility, increasing the risk of morbidity and mortality in CKD patients with significant~     impact on quality of life of these patients. Thus, patients with CKD have poor quality of~     life, high incidence of cardiovascular diseases, high prevalence of endothelial dysfunction,~     the consequent increase in arterial stiffness and serum concentration of asymmetric~     dimethylarginine (ADMA). It is believed that the conditioning of these patients may reduce~     cardiovascular risks and improve the quality of life. Aim of the study: Evaluate the impact~     of exercise training in relation to functional capacity, quality of life, pulse wave velocity~     and ADMA in patients with CKD on dialysis. Materials and methods: Is a randomized controlled~     study, with 34 CKD patients on conservative treatment, divided into control group (with~     stretching exercises and metabolic exercises) and training group, those undergoing physical~     training, aerobic and resistance during six months. Before and after exercise training,~     patients will be assessed using the SF-36 and IPAQ. Also be held assessment of pulse wave~     velocity, measurement of serum ADMA and spirometry testing. Statistical analysis consisted of~     t test for independent data or chi-square when appropriate.~   "
184083|NCT01155284|"~     Sanford Research/USD proposes to study the combination therapy of oral administration of~     sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells~     still present in patients with recent-onset diabetes and possibly regenerating their beta~     cells, while safely down-regulating the autoimmune response directed against the beta cells.~   "
184084|NCT01155271|"~     The study was designed to test the following hypotheses:~      In obese patients with OSAS, the benefit of the combination of exercise training + continuous~     positive airway pressure (CPAP) will be higher than CPAP alone in term of functional~     capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life.~      In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV)~     during cycloergometer [cycloergometer with NIV] or respiratory muscles training (spirotiger)~     in addition to cycloergometer [cycloergometer + spirotiger] will be higher than~     cycloergometer training alone [cycloergometer] in term of functional and exercise capacities.~      Dyspnea during walking test and respiratory muscle strength at baseline could influence the~     response to combined exercise training such as [cycloergometer + NIV] or [cycloergometer +~     spirotiger]~   "
184085|NCT01155258|"~     RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as vinorelbine ditartrate, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving temsirolimus together with vinorelbine ditartrate may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of giving temsirolimus~     and vinorelbine ditartrate together in treating patients with unresectable or metastatic~     solid tumors.~   "
184086|NCT01155245|"~     This study will investigate the effects on bone quality of a medication (Teriparatide) used~     to treat people with severe osteoporosis. Teriparatide is the only bone formation therapy~     that has been approved for the treatment of postmenopausal osteoporosis in Canada.~     Osteoporosis is currently diagnosed using a bone mineral density (BMD) scan, which measures~     the amount of mineral (calcium etc) in bones (the higher the amount of mineral, the lower the~     fracture risk). Although BMD is linked to bone strength and is used to measure fracture risk,~     it does not give information on bone structure (called bone geometry) which can also tell us~     a great deal about fracture risks. Clinical trials have shown that teriparatide increases BMD~     at the lumbar spine and total hip, while BMD at the forearm decreases after 20 months of~     therapy. Whether this decrease of BMD at the forearm suggests a higher risk of wrist fracture~     or a change in bone structure is unclear. Bone biopsies of the pelvis done on people taking~     teriparatide shows improvement of bone geometry (ie bone thickness and increased trabeculae~     (small interconnecting rods of bone), suggesting that a change in bone geometry at the wrist~     may be occurring as well. Currently, there is a new technology, high resolution pQCT~     (HR-pQCT) that can assess bone geometry without a biopsy. Since bone strength is affected~     both by BMD and bone structure (as well as other material properties), our group is~     interested in examining changes in bone geometry at the forearm (a non-weight bearing site)~     and ankle (a weight bearing site) in postmenopausal women with osteoporosis who receive 24~     months of teriparatide therapy. The investigators believe that this new approach of measuring~     bone strength will help us better understand whether teriparatide has different effects at~     different bone sites.~   "
184099|NCT01155076|"~     The purpose of the study is to determine the effects of 8 weeks Vitality Product~     supplementation on physical and mental function in middle-aged adults~   "
184100|NCT01155063|"~     Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical~     practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons~     for early discontinuation.~   "
184087|NCT01155232|"~     Teriparatide (PTH) is the only bone formation therapy that has been approved for the~     treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using~     a bone mineral density (BMD) scan, which measures the amount of mineral (calcium etc) in~     bones (the higher the amount of mineral, the lower the fracture risk). Although BMD is linked~     to bone strength and is used to measure fracture risk, it does not give information on bone~     structure (called bone geometry) which can also tell us a great deal about fracture risks.~     Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip,~     while BMD at the forearm may decrease after 20 months of therapy. However, bone biopsies of~     the pelvis done on people taking teriparatide show improvement of bone geometry (ie bone~     thickness and increased trabeculae (small interconnecting rods of bone), suggesting that a~     change in bone geometry at the wrist may be occurring as well. Currently, there is a new~     technology, high resolution pQCT (HR-pQCT) that can assess bone geometry without a biopsy.~     Since bone strength is affected both by BMD and bone structure (as well as other material~     properties), our group is interested in examining changes in bone geometry at the radius and~     tibia in men and women with osteoporosis who receives 24 months of teriparatide therapy.~      The investigators believe that this new approach of measuring bone strength will help us~     better understand the mechanisms of therapeutic efficacy of teriparatide. In addition,~     measuring indices of bone strength such as the material composition (bone mineral content or~     BMD) and structural properties of bone (size and shape, and microarchitecture) may provide~     more data about the mechanisms of how teriparatide treatment can decrease fracture risk. In~     the end, this data will benefit and improve patient care by allowing us to show patients and~     their providers that whether BMD increases, decreases or stay the same, there are changes in~     their bone geometric structure with teriparatide therapy that increases bone strength.~   "
184088|NCT01155219|"~     This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of~     Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially~     treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance~     to prostaglandin eye drops.~   "
184089|NCT01155206|"~     Insulin resistant states are characterized by hepatic lipoprotein (VLDL) particle~     overproduction. Numerous hormonal and nutritional factors are known to influence hepatic~     lipoprotein particle production, including insulin and free fatty acids (FFA). In contrast to~     the liver, the intestine has traditionally been viewed as a 'passive' organ with respect to~     lipoprotein production, with intestinal lipoprotein particle production determined mainly by~     the amount of fat ingested and absorbed. Glucagon plays a key role in the regulation of~     carbohydrate and fatty acid metabolism and has recently been shown for the first time to~     regulate hepatic lipoprotein production in mice. Ours will be the first study to investigate~     the effect of glucagon on hepatic and intestinal lipoprotein production in humans.~   "
184090|NCT01155193|"~     Evaluation of Respiratory Syncytial Virus (RSV) Hospitalization and the impact of risk~     factors on preterm infants, infants with congenital heart disease and infants with~     bronchopulmonary abnormality of development immunized with Synagis.~   "
184091|NCT01155180|"~     You are invited to take part in a research study about the role of leptin (a fat cell hormone~     that normally circulates in the blood) on maintaining a reduced body weight. This study will~     also evaluate how leptin impacts hormone levels, metabolic rate (how many calories are used~     at rest), autonomic nervous function (the part of your brain that controls your heart rate~     and breathing), changes in body composition and your sense of appetite. Under normal~     conditions, leptin is secreted by fat cells and signals to the brain to decrease appetite and~     regulate energy usage and hormone levels. When obese individuals lose weight, their leptin~     levels go down, which may cause them to later regain the weight. This study will provide~     leptin as an investigational medication (not yet approved by the Food and Drug~     Administration) to increase the levels of the leptin hormone that normally circulates in your~     blood back to a normal range. We will see if this can help you to maintain your reduced body~     weight and improve your hormonal and metabolic function.~   "
184092|NCT01155167|"~     The aim of the study is to facilitate radial artery access for cardiac catheterization. The~     investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery~     spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized~     to topical nitroglycerin + lidocaine versus placebo.~   "
184093|NCT01155154|"~     Research Question: In emergency department patients with simple hand cuts, do prophylactic~     antibiotics reduce the risk of wound infections?~   "
184094|NCT01155141|"~     FSGS is an immunologic disorder wherein circulating immune proteins cause damage to the~     kidneys and progressive injury and scarring. Corticosteroid therapy is occasionally, but not~     nearly universally, successful in reducing proteinuria, and when patients respond, they have~     a favorable prognosis. The investigators believe that ACTH therapy (H.P. Acthar Gel) can~     provide a more rapid, well tolerated reduction in glomerular injury.~   "
184095|NCT01155128|"~     Introduction: Chronic kidney disease (CKD) is now an important public health issue. While~     0.1% of the population is on dialysis, approximately 4.5% of subjects have renal dysfunction~     (glomerular filtration rate <60 ml/min/1.73 m2). These patients have a high mortality of~     cardiovascular disease (CVD) with low quality of life and survival, despite high expenditure~     on their treatment. Hypertension (SAH) is both a cause and a complication of CKD. In~     addition, CKD and hypertension are risk factors for CVD. The nephropathy that are not on~     dialysis are less studied than those on dialysis. Strategies are needed to maintain renal~     function in these patients and mitigate the risk factors for CVD. A sedentary lifestyle can~     be an important determinant of morbidity of mortality. This study aims to determine the~     effect of exercise in patients with CKD not yet on dialysis.~      Methodology: A randomized clinical trial in hypertensive patients with CRF. After recruitment~     of participants and completed baseline surveys, those eligible for inclusion and consented to~     participate in the study will be randomly assigned. We use the technique of randomization in~     blocks of fixed size of six persons.~      Variables to be collected: demographic, socioeconomic, behavioral, anthropometric, blood~     pressure, laboratory tests (anemia, the lipid profile, blood glucose, inflammatory markers~     and number of peripheral endothelial progenitor cells) and quality of life. These patients~     will be re-interviewed in the middle period of the study (10 weeks) at the end of the~     intervention (20 weeks) and 10 weeks after the end of the intervention. The intervention~     group will participate in two weekly sessions of exercise.~      Therefore, facing the epidemic of CKD, this study intends to fill the data gaps about the~     impact of physical activity in patients with CKD on dialysis.~   "
184096|NCT01155115|"~     The objective of this study is to compare the lower airways inflammatory response to~     infection/pulmonary exacerbation among children known to have Primary Ciliary Dyskinesia~     (PCD) with children known to have Cystic Fibrosis (CF) as measured by the presence of~     inflammatory mediators in expectorated/induced sputum.~   "
184097|NCT01155102|"~     The objective of this study was to prove the bioequivalence of Anastrozole Tablet under~     fasted conditions.~   "
184102|NCT01155037|"~     This is a randomized, open label, phase II trial to evaluate the safety and immunogenicity of~     two different schedules of vaccination against influenza A H1N1 in HIV-infected individuals,~     in which each of the randomized groups will be compared with HIV-negative volunteers~     vaccinated with the regimen indicated by the Brazilian National Immunization Program. Will be~     included in the study HIV-infected patients, stratified by CD4 count (< 200 cells/mm3 or >~     200 cells/mm3) at the time of screening for the study, not receiving antiretroviral therapy~     treatment or receiving stable treatment for at least 8 weeks, with no plans to change over~     the next 6 months, eligible to receive vaccine against influenza A H1N1. The control group~     will be formed by HIV-negative individuals, confirmed by serology performed at screening,~     eligible to receive vaccine against influenza A H1N1. Patients infected with HIV will receive~     one of two possible vaccination regimens: 1) 3.75 µg in two applications 21 days apart, 2)~     7.5 µg in two applications 21 days apart. The volunteers in the control group will receive a~     single application of 3.75 µg dose of the vaccine. The study's hypotheses are: 1) The vaccine~     against the H1N1 virus promotes antibody titers above the level specified for protection~     (seroconversion), being as safe and well tolerated in patients HIV-1 infected as in non~     HIV-infected volunteers; 2) The proportion of seroconversion for H1N1 virus vaccine at a dose~     of 3.75 µg in HIV-1-infected patients is similar to the proportion of seroconversion induced~     by the same vaccine at a dose of 7.5 µg; 3)The proportion of seroconversion with one dose of~     the vaccine against H1N1 virus is similar to the proportion after the second dose.~   "
184103|NCT01155024|"~     The purpose of this study is to evaluate a new prosthetic socket construction technique in~     order to improve the quality of care to lower extremity amputees.~   "
184104|NCT01155011|"~     The purpose of this study was to assess whether a 6-month multilevel physical activity~     intervention can significantly increase physical activity levels in sedentary adults, 65 and~     older, living in Continuing Care Retirement Communities (CCRCs).~      Sedentary residents (N=307) in 11 CCRCs received the multilevel MIPARC intervention or a~     control health education program for 6 months. A group randomized control design was employed~     with site as the unit of randomization. The intervention was delivered through group~     sessions, phone calls, printed materials, tailored signage and mapping and targeted peer led~     advocacy efforts.~   "
184105|NCT01154998|"~     There is a rare condition causing scarring of the lungs termed interstitial lung disease.~     This comprises a group of conditions which can be divided into separate diseases. The aim of~     this study is compare a group of patients (the cases) with 2 types of this disease (fibrotic~     non-specific interstitial pneumonia (NSIP) and idiopathic pulmonary fibrosis (IPF)) with~     patients without the disease. The study will look at the 2 groups and their exposures to~     factors such as medications, smoking, previous jobs, previous medical problems and~     specifically heart disease and any operations or procedures involving the heart. There have~     been previous studies showing a link between heart disease and scarring of the lungs. This~     study will look at whether this association is stronger in one or the other type of lung~     scarring diseases.~   "
184106|NCT01154985|"~     This is a controlled study to determine the effectiveness and safety of ethyl icosapentate~     (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).~   "
184107|NCT01154972|"~     When a person has breast cancer it is necessary to find out whether the cancer has spread to~     the lymph nodes in the armpit because if it has, further treatment is likely to be needed.~     There are many of these nodes but when the breast cancer spreads, it does so in a~     step-by-step fashion, starting with the so-called Sentinel Lymph Node (SLN). At present, the~     only way to be sure whether there is cancer in the lymph nodes or not is to perform an~     operation to remove at least the SLN. If the pathologist finds cancer in the SLN, a second~     operation is usually required to remove further nodes in case they contain cancer too.~     Surgical removal of the lymph nodes in the armpit can cause difficulties for the patient~     afterwards, such as pain and swelling in the arm. If there is no cancer in the SLN, no~     further operations on the armpit are needed. The investigators wish to find out whether in~     some patients, operations on the armpit can be avoided completely. The first step in doing~     this is to test whether the investigators can find out which is the SLN before the operation,~     using a combination of an injection and ultrasound scanning. The injection - into the skin of~     the breast - would be a radioactive substance, which is the usual way the surgeon finds the~     SLN. The radioactive substance collects in the SLN and the investigators would use a gamma~     probe over the surface of the armpit to detect the radiation. In this initial study, the~     investigators would aim to find the SLN before the operation and place a marker wire in it so~     that the surgeon could check whether the investigators had found the correct node.~   "
184108|NCT01154959|"~     The immune responses in latent tuberculosis are poorly understood. While it is difficult to~     define the onset of latency during natural infection, patients undergoing treatment for~     tuberculosis are driven into a state of latency or cure. The present study on the effect of 3~     and 4 month regimens containing moxifloxacin in sputum smear and culture positive pulmonary~     tuberculosis (TRC Study number 24) offers us the opportunity to study definitive immune~     responses pre and post treatment. We will evaluate a variety of innate and adaptive immune~     responses in patients before and after treatment and our study will compare the differences~     in immuno-phenotype (eg. Markers of T, B and NK cell activation, proliferation and regulatory~     phenotype) and function (eg. Production of cytokines, proliferative responses to TB antigens)~     at different time points following treatment. In addition, since a small percentage of~     patients will undergo relapse following treatment, the kinetics of immune responses in these~     patients will used to assess immunological predictors of relapse in tuberculosis.~   "
184109|NCT01154946|"~     The aims of this study are~        -  to confirm whether detrusor after-contraction (DAC) is a true contraction or not with a~          new approach~        -  and to understand clinical implication of DAC~   "
184110|NCT01154933|"~     Exenatide has been shown to result in better glycemic control in type II diabetes patients.~     Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to~     decreased inflammation by virtue of better glycemic control and weight loss.~      The purpose of this study is to determine if the addition of Exenatide to diabetic patients~     will reduce the requirements of insulin particularly the short acting insulin. Exenatide may~     also lead to decreased inflammation by virtue of better glycemic control and weight loss, or~     an independent effect.~   "
184111|NCT01154920|"~     The goal of this clinical research study is to learn which chemotherapy combination is more~     effective in treating locally advanced head and neck squamous cell carcinoma. The side~     effects of these combinations will also be studied.~   "
184112|NCT01154907|"~     Schistosomiasis is a poverty-related water-transmitted parasitic disease affecting more that~     200 million people world wide. Infection with Schistosoma haematobium may cause Female~     Genital Schistosomiasis (FGS) with pathological lesions in the female genital tract,~     especially the cervix. Findings indicate that FGS is a hitherto under-diagnosed illness of~     young women in endemic poor tropical countries, deserving further attention. A~     cross-sectional study from Zimbabwe indicated that the pathologic genital lesions were~     unchanged two years after praziquantel treatment in adult women whereas in those who had been~     treated with praziquantel in childhood the prevalence of genital lesions was significantly~     lower. Furthermore, a higher prevalence of HIV was detected in women with FGS compared to~     those without. The proposed project aims at achieving a better understanding of how annual~     distribution of praziquantel to pre- and post-pubertal schoolgirls may prevent FGS. This~     information can be of use in current schistosomiasis control programs in the near term~     resulting in improved strategies for treatment. Preventing or reducing the risk of FGS and~     genital lesions will lead to improved reproductive health among in women living in~     schistosomiasis endemic areas.~      Project Goal: Contribute to a reduction of the global burden of female genital~     schistosomiasis (FGS) through improved knowledge about the prevention of gynecological~     lesions and through improved diagnosis of FGS.~   "
184113|NCT01154894|"~     In a double-blind, placebo-controlled 16-week trial investigators administered daily doses of~     either youths with autism spectrum disorders.ARA and DHA supplementation significantly~     improved communication as well as social withdrawal symptoms. This pilot study provides the~     first evidence that supplementation with larger ARA doses added to DHA improve impaired~     social interaction in youths with Autism Spectrum Disorders (ASD).~   "
184114|NCT01154881|"~     This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood~     glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2~     diabetes.~   "
184115|NCT01154868|"~     The purpose of this study is to document and evaluate how a bone graft material (Healos®) can~     help rebuild bone width. Dental implants can only be placed when enough bone is found and~     this bone graft may help to rebuild bone width for dental implant placement. The ultimate~     goal of this study is to evaluate how this graft material can help bone healing.~   "
184116|NCT01154855|"~     The goal of this project is to study the immune activity of certain proteins present in the~     blood of patients with severe periodontal disease. Periodontal disease (gum disease) is the~     major cause of tooth loss among adults. Moderate to severe periodontal disease is reported to~     affect 5-15% of American adults. It begins with an infection of the tissues surrounding the~     teeth, and leads to a worsening inflammatory response. This study will aid in clarifying the~     way in which gum disease might affect certain systemic diseases.~   "
184117|NCT01154842|"~     Serum FGF-23 levels will be measured in patients with a history of coronary artery disease~     and aortic valve calcifications.It will be searched whether patients with MPI>0.47 had higher~     or lower serum FGF-23 levels than those with MPI<0.47. Correlations will be examined between~     log FGF-23 levels and LVMI and MPI. Uni and Multivariable-adjusted regression analyses~     regarding whether increased log FGF-23 concentrations are independently associated with~     increased left ventricular mass index and increased MPI, will be performed.~   "
184118|NCT01154829|"~     The investigators want to relate disturbances in first-episode schizophrenic patients in~     (dopaminergic) D2 receptors, brain structure, brain function, and information processing to~     each other and to psychopathology. Additionally, the investigators want to examine the~     influence of D2 receptor blockade on these disturbances. The investigators expect~     disturbances in the dopaminergic system at baseline to correlate with specific structural and~     functional changes and with disruption in information processing as measured with~     psychophysiological and neurocognitive methods - and investigators expect D2 receptor~     blockade to reverse some of the functional and cognitive impairments.~   "
184119|NCT01154816|"~     This phase II trial is studying the side effects of and how well alisertib works in treating~     young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
184120|NCT01154803|"~     The purpose of this study is to determine whether 14 days nutritional supplementation with~     Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection~     will prevent malnutrition and reduce the frequency of morbidity.~   "
184121|NCT01154790|"~     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of~     3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7~     total days in healthy volunteers.~   "
184122|NCT01154777|"~     Neurofeedback, a neuro-cognitive training method based on operant conditioning, will be~     employed with 90 children with the Autistic Spectrum Disorders (ASD) over a 60 session~     training period to improve the limiting behavioral and sensory symptoms Autism presents (with~     each collaborative site working with 45 of the 90 participants). This study seeks to~     demonstrate that Neurofeedback training, a non-invasive approach based on Learning Theory,~     will mitigate presenting symptoms of Autism, and ultimately render the person with Autism~     significantly more able to interact with his/her environment successfully, independently~     function on a day-to-day basis, and improve overall mental health.~   "
184123|NCT01154764|"~     This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the~     pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.~   "
184124|NCT01154751|"~     Long-term, observational, prospective, multicenter registry following patients who have been~     implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in~     the superficial femoral and/or femoropopliteal arteries.~   "
184125|NCT01154738|"~     The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and~     remifentanil.~   "
184285|NCT01152632|"~     Selecting acupoints along meridians is the predominant principle in acupuncture treatment,~     and it is also considered to ensure acupuncture efficacy. This experiment is to investigate~     whether specific brain networks gradually come in formation in accordance with this kind of~     acupoint selection methods.~   "
184126|NCT01154725|"~     The purpose of the experiment is to study the effect it has on patients' quality of life if~     they go through a structured process marked by intensified and specialized effort by ostomy~     nurse. This includes close monitoring during hospitalization, telephone contact and guidance~     following discharge and participation in a group based patient school up to 4 months after~     discharge .~      At the same time the study also examines what the economic effect of following the~     intervention will have.~   "
184127|NCT01154712|"~     Pathological gambling (PG) is characterized by a persistent pattern of continued gambling~     behavior despite its adverse consequences. PG is a chronic, progressive, male-dominated~     disorder, which has a prevalence of 1% to 3.4% among US adults. Deep transcranial magnetic~     stimulation (TMS) is a novel neuro-stimulation method capable of inhibiting neuronal activity~     when given in low frequency. The hypothesis of this study is that , Pathological gambling~     will be ameliorated if low frequency magnetic field using Brainsway H1 coil will be applied~     to the left dorso-lateral prefrontal cortex of these patients.~   "
184128|NCT01154699|"~     Asthma is an extremely common disorder, which is becoming more prevalent. The purpose of this~     study is to examine how nocturnal lung volumes contribute to asthma severity, which may~     explain part of the link between asthma and obesity. The investigators seek to test the~     hypothesis that raising lung volumes during the night will improve asthma symptoms. The~     investigators work may lead to new targets for therapy.~   "
184129|NCT01154686|"~     The overall objective of the current study is to determine whether computerized Working~     Memory (WM) training will enhance WM capacity in college students with Attention Deficit~     Hyperactivity Disorder (ADHD)/Learning Disabilities (LD). There are also three additional~     objectives. The first is to determine whether improvements in WM will generalize to secondary~     outcome tasks, such as inhibitory control and planning. The second objective is to examine~     whether WM training will also ameliorate ADHD symptoms of inattention and hyperactivity. The~     last objective is to investigate whether improvements will be maintained at a two month~     follow-up period.~      It is expected that the computerized WM training program will enhance WM capacity in college~     students with ADHD. In addition, it is believed that these increases in WM capacity will also~     lead to improvements in other executive functions. It is also hypothesized that WM training~     will lead to a reduction in ADHD symptomology. Lastly, these improvements should be~     maintained at three month follow-up.~   "
184130|NCT01154673|"~     This trial will investigate the efficacy and safety of intensified antiretroviral treatment~     that includes raltegravir and maraviroc during the early stages of HIV infection. With the~     proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to~     investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART~     backbone to further decrease the viral load in acutely infected treated HIV infected~     individuals.~   "
184131|NCT01154660|"~     As increasing tidal volume, the cross sectional area and circumference of Internal Jugular~     Vein (IJV) could increase. And In the previous study, Trendelenburg position can increase~     size of IJV. So investigators would compare the cross sectional area, circumference of IJV~     and peak airway pressure in neutral and Trendelenburg position~   "
184132|NCT01154647|"~     Both patients with peripheral structural pathologies, like rheumatoid arthritis~     (RA)-patients, or patients with central sensitivity syndromes (CSS) suffer chronic pain. CSS~     are characterized by an increased responsiveness of central pain neurons. An impaired~     endogenous pain inhibition is already demonstrated in CSS. In the present study the~     investigators want to evaluate the efficacy of pain inhibition in response to physical~     stressors and whether the efficacy is opioid-mediated in two chronic pain populations (RA &~     CCS) compared to controls.~      Therefore a triple-blinded randomized controlled trial (RCT) with cross-over design will be~     performed. The efficacy of wind-up of pain and spatial summation of pain is evaluated before~     and after a submaximal exercise, while the experimental group receives a selective serotonin~     reuptake inhibitor. Participants are 20 RA-patients and 20 CSS-patients, more specific~     patients with fibromyalgia and chronic fatigue syndrome, and 30 healthy controls. This way,~     the investigators analyze how pain inhibition reacts on different types of physical stressors~     in different pain patients and if pain inhibition is opioid-mediated.~   "
184133|NCT01154634|"~     The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy~     male subjects.~   "
184134|NCT01154621|"~     The aim of this study is to examine the safety and tolerability of a single dose of AZD9742~     in elderly individuals.~   "
184135|NCT01154608|"~     Pancreatic exocrine insufficiency is known to impair nutrient absorption, especially fat, but~     few data exist about protein absorption. We aimed to investigate this question and assess the~     enzyme substitution efficiency using a sensitive method.~   "
184136|NCT01154595|"~     The overall objective of this project is to assess the effectiveness and cost-effectiveness~     of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children~     aged 6-36 months if embedded in a program of conditional household food assistance.~   "
184137|NCT01154582|"~     The project aims to precisely quantify the postprandial amino acid utilization of egg~     proteins in vivo in humans, and also to assess their satiating power, in relation with~     nutrient postprandial waves and incretin secretions. For that purpose, 2 independent studies~     are conducted. The first one is realized using stable isotopes on 8 volunteers ingesting an~     egg test meal. The second one is a cross over design performed on 30 volunteers to compare~     the satiating effect of 2 equivalent snacks: whole eggs or cottage cheese.~   "
184149|NCT01154426|"~     This phase I trial is studying the side effects and best dose of giving ABT-888 together with~     gemcitabine hydrochloride in treating patients with advanced solid tumors. ABT-888 may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888~     together with gemcitabine hydrochloride may kill more tumor cells.~   "
184150|NCT01154413|"~     To asses the effectiveness of implementing a diabetes management protocol (early~     insulinization, avoiding use of SSI) in a hearth hospital's non-intensive care unit.~   "
184286|NCT01152619|"~     This multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the~     safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis~     who are otherwise healthy. The anticipated time on study treatment is 2 weeks.~   "
184138|NCT01154569|"~     Bariatric (obesity) surgery has become the preferred treatment option for patients with~     severe obesity and is increasing in popularity. It is commonly performed, with nearly 350 000~     operations in the world every year. The most common type of bariatric surgery is gastric~     bypass, in which stomach size is reduced by 95% and the upper intestine is bypassed. Bypass~     of the upper intestine may lead to medication malabsorption, although this potential adverse~     effect has received little study.~      The objective of this study is to determine whether gastric bypass reduces the absorption of~     a azithromycin, a medication commonly prescribed first-line for infections, especially~     pneumonia. Patients and non-surgical controls will receive a single dose of azithromycin~     under highly standardized study conditions. The absorption of azithromycin will be calculated~     and compared between surgical and non-surgical study groups.~      The investigators hypothesis is that there will be a significant reduction in the absorption~     of azithromycin in gastric bypass patients compared to non-surgical controls. This raises the~     possibility that post-gastric bypass patients treated with azithromycin may fail to respond~     to treatment, become worse and even die. This study will have important implications for the~     large number of past and future gastric bypass recipients.~   "
184139|NCT01154556|"~     An observational retrospective study of NNRTI experienced patients who have virologically~     failed. The study aims to assess resistance profiling and subsequent prescription patterns of~     patients on NNRTIs~   "
184140|NCT01154543|"~     To determine the efficacy of Famvir 500mg bd as suppressive antiviral therapy for acute~     genital Herpes simplex virus (HSV) outbreaks in HIV subjects.~   "
184141|NCT01154530|"~     Background:~      Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a surgical technique that has been~     rapidly evolving over the last five years. The technique probably has a great potential in~     surgical gastroenterology, urology and gynaecology.~      The technique is based on the idea of minimally invasive surgery. The human organism is~     affected by a stress response when exposed to surgery. This stress response can be minimized~     by reducing the size of the openings whereby the surgeon gains access to the organs. This~     affects how quickly a patient recovers after surgery and can be discharged and resumes daily~     life and work. The same principal have been responsible for the surgical evolution in the~     last 15-20 years where many procedures have gone from traditional open operations with large~     incisions in the abdominal wall to laparoscopic surgery with cameras through small holes in~     the abdominal wall.~      The latest addition to minimal invasive surgery is NOTES. Here the surgeon gains access to~     the abdominal organs with flexible endoscopes through the body's natural openings i.e. the~     mouth and stomach. With this technique the surgeon avoids cutting through skin and muscle of~     the abdominal wall, thus minimizing the surgical stress response. This minimizes~     postoperative pain, the incidence of incisional hernias, eliminates wound infection, and~     properly prevents scar tissue formation inside the abdominal cavity which way lead to ileus.~     The end result is a quicker discharge and a better cosmetic result.~      It has been shown in numerous animal studies that NOTES is feasible and in recent years a~     rapidly increasing number of published patient series.~      However, there is a risk of infection associated with accessing the abdominal cavity through~     a natural body opening, which initially is unclean and can not be disinfected in the same way~     as the skin of the abdominal wall.~      Numerous microbiological pig studies have shown that there is transfer of bacteria from the~     body opening (i.e. mouth) to the abdominal cavity when performing NOTES, but this~     contamination have no correlation to infection after surgery, neither in terms of healing or~     survival.~      It is unclear from the literature whether patients should be offered proton pump inhibitor~     (PPI) therapy to reduce the acidity of the stomach before NOTES interventions. The rationale~     has been that such a treatment can make the gastric juices less acidic and thereby reduce the~     incidence of chemical peritonitis, which can occur when acidic juices flows from the stomach~     and into the abdominal cavity. It is known however that the acidic environment of the stomach~     provides a natural barrier for bacteria. Making the gastric juices less acidic could~     potentially increase the risk of bacterial peritonitis.~      It is known that the bacterial content of the stomach is low due the acidic environment but~     bacteria passed down from the mouth and throat with the endoscope could potentially result in~     bacterial peritonitis.~      That bacteria from the throat can lead to infections due to instrumentation is known from~     intensive care units. Ventilated patients may risk getting pneumonia with bacteria from the~     throat. Several studies have shown that using mouthwash with a chlorhexidine solution can~     reduce the risk of ventilator associated pneumonia.~      Hypothesis:~      Mouthwash with 2 cl 0,2% chlorhexidine solution before a gastroscopy reduces the bacterial~     content in cultures taken from the stomach and the endoscope after a gastroscopy.~      Simultaneous PPI treatment gives higher bacterial counts in the cultures.~   "
184142|NCT01154517|"~     The study is trying to prove that the history and physical exam (H&P) in the emergency~     department is the most important tool in exam of patients. The investigator is attempting to~     correlate the time of the H&P of residents and attendings to the accuracy of diagnosis.~   "
184143|NCT01154504|"~     1. Study Hypothesis:~             -  The decrease of plasma adrenomedullin (ADM) concentration by ultrafiltration and~               isovolumetric hemofiltration in patients with acute III and IV Class New York Heart~               Association Functional(NYHA) heart failure is more pronounced than a standard~               diuretic treatment and is related with clinical improvement.~        2. Outcome Measurements:~      To correlate the adrenomedullin plasma levels with clinical treatment, ultrafiltration and~     hemofiltration related to:~        -  Brain natriuretic peptide (BNP) level~        -  angiotensin II level~        -  sympathetic nervous activity~        -  oxydative stress~        -  clinical outcome at the beginning, at discharge and 90 days after randomization.~   "
184144|NCT01154491|"~     In order to evaluate the efficacy of ferric carboxymaltose + erythropoietin versus ferric~     carboxymaltose versus placebo in reducing the percentage of patients who receive red-cell~     transfusion in the perioperative period of hip fracture, a multicenter, randomized, parallel~     groups, double-blind clinical trial in adult patients admitted for osteoporotic hip fracture~     is designed. Required sample size is of 87 patients per arm (87x3 = 261). Primary efficacy~     variable is the percentage of patients who receive red-cell transfusion during~     hospitalization; secondary end-points: average red-cell packs per patient,haemoglobin at 24 h~     and 72h after the intervention, at the time of hospital discharge and 60 days after hospital~     discharge, hospital stay and mortality during hospital-stay and 60 days afterwards. Adverse~     clinical events and side effects are assessed as safety variables. In addition health related~     quality of life will be measured at inclusion and after 60 days. A cost-efficacy analysis (by~     means of incremental cost-efficacy method using as a primary endpoint each patient not~     requiring transfusion, and as secondary end-point every patient who survived the index~     admission is performed). The investigators would like to demonstrate a double benefits:~     optimizing precious resource such as blood products and reducing complications arising from~     their use.~   "
184145|NCT01154478|"~     The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and~     omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism~     and other cardiovascular risk factors in people at high cardiovascular risk.~   "
184146|NCT01154465|"~     Central venous catheterization (CVC) in ICU is very common. It is associated with many~     complications. These complications are now well identified in the literature. They are~     primarily mechanical, infectious and thrombotic events. Many measures are taken to reduce~     them as the choice of insertion site, strict aseptic technique during insertion and type of~     catheter used. However, despite these measures, it appears that the incidence of these~     complications is still high. The technique of ultra-sound guided (USG) catheter insertion has~     shown its effectiveness in reducing complications in the general ICU population. The increase~     in obesity in the general population is accompanied by an increase in the obese population in~     the ICU (BMI > 30 kg.m-2). Many studies have investigated the effect of obesity on morbidity~     and mortality in ICU. Some studies found a higher rate of catheter infections in obese~     patient. Moreover, insertion of central venous catheter is technically more difficult in~     obese patients.~      To the investigators knowledge there are no studies on the impact of USG central venous~     catheterization in obese patients in ICU.~      The objective of this prospective randomized controlled study is to demonstrate the~     superiority of USG central venous catheterization (jugular or femoral) on complications in a~     population of obese patients. 450 patients will be included and dispatched in two groups~     (jugular or femoral) according to the chosen site of catheter insertion. In both groups,~     patients will be randomized in the USG technique or the usual anatomical technique.~      The rate of complications (mechanical, thrombotic or infectious) will be the primary~     endpoint. Secondary endpoints will be the following: rate of catheter colonization, rate of~     catheter-related bacteremia, rate of failure during insertion, number of punctures, procedure~     timing and mortality The investigators hope to establish a benefit in the use of USG central~     venous catheterization in obese ICU patients and thus contribute to improve the quality of~     care.~   "
184147|NCT01154452|"~     This randomized phase I/II clinical trial is studying the side effects and best dose of~     gamma-secretase/notch signalling pathway inhibitor RO4929097 when given together with~     vismodegib and to see how well they work in treating patients with advanced or metastatic~     sarcoma. Vismodegib may slow the growth of tumor cells. Gamma-secretase/notch signalling~     pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving vismodegib together with gamma-secretase/notch~     signalling pathway inhibitor RO4929097 may be an effective treatment for sarcoma.~   "
184148|NCT01154439|"~     RATIONALE: Drugs used in chemotherapy, such as mitoxantrone hydrochloride, cytarabine,~     etoposide, and idarubicin, work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. Everolimus may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the cancer. Giving everolimus together with combination chemotherapy may kill more~     cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with mitoxantrone hydrochloride, cytarabine, etoposide, and idarubicin in~     treating older patients with newly diagnosed acute myeloid leukemia.~   "
184151|NCT01154400|"~     The aim of this study is the first aim of a NIH project that consists of 3 aims. The first~     aim examines the acute effects of two high-quality milk proteins (casein vs. whey) on~     whole-body and muscle protein metabolism in COPD patients with severe loss of muscle mass and~     the effects of adding leucine. The principal endpoints will be the extent of stimulation of~     net whole body protein synthesis as this is the principal mechanism by which either amino~     acid or protein intake causes muscle anabolism. After determining the optimal nutritional~     formulation based on the first aim we will continue to work on the second and third aim where~     fish oil supplementation will be part of the nutritional intervention as well.~   "
184152|NCT01154387|"~     Induction therapy with antibodies is administered during transplant surgery and for a short~     period of time following transplant surgery in an effort to render the immune system less~     able to mount an initial rejection response. In general, induction therapy is associated with~     better outcomes compared to the absence of induction therapy. However, currently used~     induction agents, some of which are not labeled or indicated for induction therapy in~     transplantation, have drawbacks related to long-term immune system suppression increasing~     susceptibility to opportunistic infections or malignancies, and other immune-mediated side~     effects.~      An unmet medical need exists for a more specific approach to prevent acute organ rejection,~     without unnecessarily exposing the patient to non-specific or open-ended immune suppression,~     which may exacerbate the risks of infections and malignancies. TOL101 is a novel antibody~     that targets a very specific immune cell type that is critical in the acute organ rejection~     response. In this two-part study, TOL101 will be evaluated for the prophylaxis of acute organ~     rejection when used as part of an immunosuppressive regimen that includes steroids, MMF, and~     tacrolimus in first time kidney transplant recipients.~      This study will test the hypothesis that a more specific approach (with TOL101) to prevention~     of acute organ rejection may provide similar or better efficacy than the currently used~     induction antibodies (such as Anti-Thymocyte Globulin or Thymoglobulin) while carrying fewer~     risks in terms of opportunistic infections, malignancies and adverse effects.~   "
184153|NCT01154374|"~     The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment~     of subjects with diabetic foot ulcers (DFUs).~   "
184154|NCT01154361|"~     This is a multicenter study recruiting patients with angioedema induced by ACEI.~      Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients~     with ACE inhibitor induced angioedema which the investigators have been previously treated in~     the investigators centers with current standard therapy (250 mg methylprednisolon and 2 mg~     clemastine).~      In cases with fast progression of edema after application the study-drug, a second~     application with icatibant could be necessary. Rescue medication and intervention.~   "
184155|NCT01154348|"~     The purpose of this study is to determine the safety and pharmacokinetics of double-blind~     S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes~     mellitus~   "
184156|NCT01154335|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of the combination~     of OSI-906 and everolimus for the treatment of patients with refractory metastatic colorectal~     cancer.~   "
184157|NCT01154322|"~     The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating~     obstructive sleep apnea (OSA) in a pediatric population.~   "
184158|NCT01154309|"~     The investigators will adapt and test an existing treatment (group CBT for depression) for~     use in outpatient substance use treatment settings as delivered by trained substance use~     counselors. The investigators expect that treatment will lead to improved depression and~     substance use outcomes.~   "
184159|NCT01154296|"~     Project Aware is a randomized controlled clinical trial in which individuals seeking medical~     or health services at sexually transmitted disease (STD) clinics are recruited to participate~     in a multi-center HIV testing and counseling study. The investigators will assess the~     relative effectiveness and cost-effectiveness of (1) on-site HIV rapid testing with brief,~     participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information~     only. The investigators will evaluate the effect of counseling on one primary outcome: STI~     incidence. Secondary outcomes will be reduction of sexual risk behaviors, substance use~     during sex (i.e., being under the influence during sex) and cost and cost effectiveness of~     counseling and testing. Participants will be assessed for sexually transmitted infections,~     HIV testing history and sexual and drug use risk behaviors at baseline and at 6-months~     follow-up. Approximately 5,000 individuals seeking medical or health services from~     approximately 9 STD clinics throughout the United States will be randomized. These~     individuals will be 18 years of age or older and efforts will be made to recruit a sample of~     study participants that reflects the proportion of minorities and gender in the STD clinic~     performance sites from which the investigators are recruiting.~   "
184160|NCT01154283|"~     The purpose of the study is to test whether noninvasive positive pressure ventilation (NIPPV)~     without expiratory positive airway pressure (EPAP) (inspiratory positive airway pressure~     (IPAP)-only) will result in an increase in patient usage of NIPPV compared with standard,~     Bi-level NIPPV. Secondarily, the investigators will assess measures of dyspnea, quality of~     life, patient satisfaction, and side effects.~   "
184161|NCT01154270|"~     The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity and~     efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and~     carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local~     control, disease-free survival, and toxicity. Planned accrual of the trial includes 54~     patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland~     malignancies. Treatment consists of 24 GyE carbon ions (8 fractions) and 50 Gy IMRT (2.0 Gy/~     fraction).~   "
184162|NCT01154257|"~     Cleaning the mouth is difficult in critically ill patients who require support from a~     breathing machine (ventilator). This is because the plastic (endotracheal) tube which is a~     necessary interface between patient and ventilator impedes cleaning. New evidence suggests~     that poor oral health may be linked to ventilator associated pneumonia. Throughout the world~     both toothbrushes and foam swabs are used to clean the teeth and remove dental plaque,~     however it is unknown if one method is more effective than the other. The purpose of this~     study is to establish which (if any) method is most effective at removing plaque in this~     population of patients.~   "
184164|NCT01154231|"~     The survey is intended to investigate the following matters, etc. under the actual use status~     after marketing in all patients who are administered this drug for a certain period of time~     after the launch.~        1. Occurrence status of adverse events~        2. Factors that may influence the safety~        3. Efficacy In addition, the following occurrence statuses will be investigated as priority~          items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic~          reaction, and Thrombosis.~   "
184165|NCT01154218|"~     The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule~     (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC~     relative to Powder in Capsule (PIC) of crizotinib, and lack of an effect of high fat meal on~     the pharmacokinetics (PK) of crizotinib when administered as CIC Formulation in healthy~     volunteers.~   "
184166|NCT01154205|"~     The purpose of the registry is to assess workload of a Home Monitoring based follow up for~     Biotronik ICD and CRTD patients.~   "
184167|NCT01154192|"~     In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is~     excessive ovarian androgen production marked by increased serum testosterone (T) and~     androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis~     that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene~     expression with accentuated 17-hydroxylase activity leading to exaggerated~     17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast,~     T and A responses did not distinguish between PCOS and normal women, although these androgens~     were clearly greater in the former compared to the latter group. As a result, 17P~     responsiveness has been employed to determine the functional capacity of the ovary to produce~     androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a~     dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU. The investigators propose~     to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG~     after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls.~     This will allow for a comparison of these adolescents' ovarian functional capacity to produce~     androgens.~   "
184168|NCT01154179|"~     During patients' stay in the hospital, some of the patients may require artificial feeding~     for various reasons either through a vein or through a tube going directly to the gut.~     However, the amount of feeding that can be considered 'adequate' is unclear due to lack of~     research data. The current evidence the investigators have suggests that doctors might be~     giving patients more than they require, which might carry some risks. This hasn't been proven~     until now and there is no evidence as yet to show investigators exactly how much the doctors~     should feed patients.~      The aim of the study is to see whether feeding patients less than what they are currently~     been feed is associated with better outcome.~      The patients will be randomly (like tossing a coin) allocated into 2 groups. One group will~     get 100% of the current amount; the second group will get 60%. The investigators will then~     compare the groups to decide if feeding patients less than the current practice is associated~     with better outcomes.~   "
184169|NCT01154166|"~     This is a phase III, multicenter, randomized, double-blind, parallel group,~     placebo-controlled study to compare the efficacy of 6-months therapy of ropinirole Prolonged~     Release (PR) with that of placebo as adjunctive therapy to L-dopa in Parkinson's disease~     patients not optimally controlled on L-dopa. This study will be conducted in China. Subjects~     will have total 14 visits over the 26 week duration of the study.~      Following screening, eligible subjects will receive study medication during the fourteen day~     placebo run-in period which they will be instructed to take in addition to their background~     L-dopa. If subjects are still eligible at the end of the placebo run-in period they will be~     randomized (1:1) to receive once daily doses of ropinirole PR or identical appearing placebo~     tablets. Dosing will start at 2 mg ropinirole PR, or placebo equivalent. During the 24 week~     treatment phase, the subjects dose will be adjusted according to the recommended schedule to~     achieve symptomatic control. All subjects must be titrated to a minimum dose of 6 mg/day. If~     sufficient symptomatic control is not achieved or maintained at a dose of 6mg/day of~     ropinirole PR, the daily dose should be increased by 2mg at weekly or longer intervals up to~     a dose of 8mg/day.If sufficient symptomatic control is still not achieved or maintained at a~     dose of 8mg/day of ropinirole PR, the daily dose should be increased by 4mg at two weekly or~     longer intervals. Further dose titration should not be conducted within the final 8 weeks of~     the treatment phase. The maximum recommended daily dose is 24mg.~      The planned reduction in L-dopa dose will begin once subjects are titrated to Dose Level 4 or~     Dose Level 5 of study medication. For each increase in study medication, there will be a~     corresponding decrease in L-dopa. If loss of symptom control occurs with the reduction in the~     background L-dopa dose, the dose of study medication should be increased to the next higher~     dose level with no adjustment in the dose of L-dopa. If loss of symptom control persists,~     subjects should be titrated up an additional dose level. Subjects who do not experience an~     improvement in symptoms following upward titration by 2 dose levels of study medication,~     should be rescued with L-dopa.~      Subjects will be dispensed down-titration medication at the study completion/early withdrawal~     visit if the patient did not enter extension study and should be scheduled to return for a~     follow up visit 4 to 14 days after the last dose of study medication. The extension study aim~     to evaluate the safety profile of ReQuip PR during long-term treatment in subjects with~     advanced parkinson's disease.~   "
184170|NCT01154153|"~     The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg)~     and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA)~     axis function as measured by serum cortisol AUC(0-24 hr) in children (>=2 to <12 years old)~     with allergic rhinitis (AR).~   "
184171|NCT01154140|"~     This study will evaluate the anti-cancer effects of crizotinib when compared with standard~     chemotherapy in patients with ALK positive lung cancer.~   "
184172|NCT01154127|"~     The ability for patients with COPD to exercise is limited due to the deterioration of their~     lung function. NVA237 is being developed to treat COPD. This study is designed to look at how~     well NVA237 improves the ability to exercise in patients with moderate to severe COPD.~   "
184173|NCT01154114|"~     The purpose of this study is to determine any differences in pharmacokinetic parameters of~     darapladib when dosed to people with moderate liver disease as compared to when dosed in~     normal healthy volunteers.~   "
184186|NCT01153945|"~     Much experimental data has suggested that thyroid hormones (T3 and T4) may modulate~     neoplastic cells and that T3/T4 deprivation may remove this stimulus. It is now well~     established that T3/T4 affects cell division/angiogenesis through binding to integrin avb3,~     commonly over-expressed on many cancer cells. In the experimental settings, mimicking~     hypothyroidism in the cells is a difficult task. Currently, the use of charcoal stripped~     serum is used. Using this method, the serum is stripped not only from T3 and T4, as intended,~     but also from central and important cytokines and growth factor. This leads to a reduced rate~     of cancer cell proliferation and thus, does not reflect the natural environment in which~     cancer cells residue under hypothyroid conditions.~      The investigators aim to characterize and establish the effects of serum from hypothyroid~     patients on the proliferation/viability of a variety of cancer cell models.~   "
184187|NCT01153932|"~     The purpose of this study is to determine whether GSK2402968 given as a continuous dose and~     as an intermittent dose is effective and safe in the treatment of Duchenne muscular~     dystrophy.~   "
184174|NCT01154101|"~     This double-blind, placebo-controlled study will be conducted at 5 study centers in the~     United States. Approximately 30 subjects with moderate to severe plaque-type psoriasis will~     take part. The study will consist of a screening period of up to 21 days, a 12-week treatment~     period with 7 on-treatment clinic visits (approximately one every 2 weeks) and a post-dosing~     follow-up clinic visit approximately 30 days after the last dose of study drug is taken.~      Subjects will be randomized to receive either 250mg, 500mg or 1000mg of study drug or~     placebo. Study drug will be taken by mouth on a full stomach, every day for 84 days.~      Vital signs, clinical laboratory results (hematology, chemistry, and urinalysis), ECGs and~     physical examinations will be assessed at periodic intervals from Day 1 through Day 84.~      A skin biopsy will be taken at the beginning and the end of the dosing period to evaluate any~     effects of the study drug on psoriasis. Investigators will perform other psoriasis~     evaluations (including the Psoriasis Area and Severity Index [PASI] and the Physician's~     Global Assessment [PGA] at 5 different times throughout the study to quantify the effects of~     SRT2104 on psoriasis activity.~      Subjects will complete questionnaires throughout the study, to document their sense of~     well-being and mood at 4 different times during the study.~      Five blood samples will be obtained at different timepoints during the study, to measure the~     amount of SRT2104 in the body.~   "
184175|NCT01154088|"~     The purpose of the observer-blinded study is to determine the immunogenicity and safety of~     one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to~     one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study~     will compare the immunogenicity of two lots of GSK's 134612 vaccine.~   "
184176|NCT01154075|"~     The purpose of this study is to evaluate the use of a novel method to measure adherence to~     immunosuppressant medications in predicting rejection episodes in children who had a liver~     transplant.~   "
184177|NCT01154062|"~     A study to evaluate pazopanib tablets in male and female adults of non-child bearing~     potential with subfoveal CNV due to neovascular AMD. The goal is to assess safety and how~     well the subjects tolerate the drug. The study will also look at how the body breaks down and~     metabolizes the drug. All subjects will start the study up to 8 days prior to receiving drug.~     Once started subjects will take one tablet each day for 28 days. A follow up visit will occur~     approximately 2 weeks after drug is stopped.~   "
184178|NCT01154049|"~     This is a phase I, open-label, single arm trial, which aims to assess the safety of the~     vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by~     conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by~     the method ELI-SPOT. Each participant will remain in the study for approximately 4 months.~     The total study duration is 10 months, considering a period of 6 months for inclusion. Will~     be included in the study subjects male and female, between 18 and 49 years, that manifest~     their will to participate in the research by signing an Informed Consent Form. Eligible~     population for the study are subjects who do not present at screening significant changes in~     renal, cardiac and liver functions, complete blood count, clotting, present no acute or~     chronic illnesses, are not in the chronic use of any medication, do not have HIV infection or~     other immunodeficiency. Pregnant or breastfeeding women will not be included. Volunteers will~     receive three doses of vaccine prepared sm14, in doses containing 50 mcg of the antigen,~     associated with adjuvant GLA-SE at a dose of 10 mcg, with an interval of 30 days between each~     application. Twenty volunteers will be included in the study. This is a convenience sample,~     established for the first test of the product in humans, for the initial safety assessment.~   "
184179|NCT01154036|"~     This study will compare the lipid-altering efficacy and safety of switching to~     co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or~     rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not~     achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis~     is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to~     both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in~     low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.~   "
184180|NCT01154023|"~     The purpose of the study was to evaluate and compare the efficacy of single interventions~     (stimulus control instructions, sleep restriction therapy) and multi-component intervention~     (stimulus control instructions and sleep restriction therapy) for chronic insomnia in~     community dwelling older adults. The subjects were randomly assigned to one of four~     conditions: stimulus control instructions, sleep restriction therapy, multi-component~     treatment (stimulus control instructions and sleep restriction therapy), or measurement~     control.~   "
184181|NCT01154010|"~     The purpose of this study is to determine if a medical device (ActiPatch) that emits a low~     frequency pulsed electromagnetic field (PEMF) will benefit patients with anterior uveitis.~     Anterior uveitis (aka iritis) is an inflammatory disease involving the front segment of the~     eye. This is a common cause of a painful red eye, and ActiPatch has been shown to be~     effective in treating tissue inflammation. The conventional treatment of iritis typically~     involves frequent administration of topical steroids which have their own inherent risks~     (development of cataracts and/or glaucoma). The purpose of this study is to determine if~     ActiPatch therapy can be used to shorten the length of time and/or quantity of steroids~     administered.~   "
184182|NCT01153997|"~     This trial is conducted in Japan. The aim of this trial is to investigate the safety profile~     of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy~     Japanese subjects. In addition pharmacokinetic parameters will be investigated.~   "
184183|NCT01153984|"~     This open-label, single-arm, multi-center study will evaluate the progression-free survival~     in participants with histologically documented, advanced and/or metastatic chemotherapy~     naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)~     positive mutations and receiving erlotinib treatment. The anticipated time on study treatment~     is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.~   "
184184|NCT01153971|"~     This study will evaluate the efficacy and safety of MabThera in combination chemotherapy,~     followed by maintenance treatment with MabThera. The anticipated time on study treatment is~     1-2 years, and the target sample size is <100 individuals.~   "
184185|NCT01153958|"~     This is a prospective, randomized, controlled and multi-center trial to assess the use of~     colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were~     planned to be enrolled in various centers in China.~   "
184190|NCT01153893|"~     The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK~     Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster~     dose or as a two dose catch-up vaccination in the second year of life to the Nigerian~     subjects previously enrolled in the primary vaccination study NCT00678301.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00678301).~   "
184191|NCT01153880|"~     Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical~     antibiotics approved for human use. In the United States (US), retapamulin is approved for~     the treatment of impetigo in persons nine or more months of age and was launched on 12 April~     2007. This five-year study is designed to examine use of retapamulin in the pediatric~     population less than nine months of age. We will conduct an annual assessment of prescription~     sales claims for retapamulin using the Integrated Health Care Information Services (IHCIS)~     National Managed Care Benchmarked Database. For each year of reporting, the observed~     frequencies of the exposure, with or without same-day, co-prescribed sales claim of~     mupirocin, will be identified. The study objectives are to determine the frequency of~     retapamulin sales in a representative US population stratified by the designated age group~     and to determine the frequency of same-day sale of the topical agent, mupirocin.~   "
184192|NCT01153867|"~     Schema focused therapy (SFT) is an innovative treatment approach to chronic, lifelong~     problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and~     techniques. This study will determine whether SFT is a suitable and effective treatment for~     chronic depression in terms of acute effects and the prevention of relapse/recurrence. The~     secondary aim of this study is to identify the underlying mechanisms of change in SFT that~     lead to recovery from depression and the prevention of future relapse/recurrence.~   "
184193|NCT01153854|"~     Rationale: Acute diarrhea (AD) is still a significant morbidity-mortality problem worldwide.~     Although oral rehydration therapy is the cornerstone, its anti-diarrheal effect is a~     controversial subject. Since ten years ago, Racecadotrilo´s safety and efficacy had been~     proved. However, a pharmacoeconomics analysis on this therapeutics has not been published~     yet.~      Objective: Evaluate the efficacy, safety, tolerability and costs associated with Racecadotril~     administration in comparison to a placebo in infants up to 24 months of age with AD in a~     hospital (mildly or moderately dehydrated) and ambulatory (no dehydrated) settings at the~     National Institute of Pediatrics in Mexico.~      Material and Methods: Randomized, double-blind, placebo controlled, clinical trial (RDBCCT)~     with pharmacoeconomics analysis (cost minimization) to realize in 454 infants with AD (270~     hospitalized and 184 outpatients), 1 to 24 months of age who concomitantly will receive ORT~     and Racecadotril (1.5mg./Kg./t.i.d. doe 5 days) (ORT-Rac Group) or placebo (ORT-Placebo~     Group). The clinical outcomes in the hospitalized infants to measure will be a) Stool output~     rate at 48hs. and at the end of the study; b) duration of diarrhea; c) percentage of~     intravenous (IV) needs and d) percentage of adverse events. The outcome variables in~     outpatient infants to measure will be a) total liquid and semi-liquid bowel movements during~     the study; b) duration of diarrhea and c) percentage of adverse events. The pharmacoeconomics~     analysis will involve a cost minimization analysis (CMA). Results will be analyzed through bi~     and multivariate analysis using STATA 11.0 for Mac, considering a p value < 0.05 as~     significant. The pharmacoeconomics model will made through decisions trees using TreAge Pro~     Healthcare v 1.2.0, 2009.~   "
184194|NCT01153841|"~     The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK~     1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix~     hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.~   "
184195|NCT01153828|"~     Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical~     antibiotics approved for human use. In the European Union (EU), retapamulin is approved for~     the treatment of impetigo and secondarily-infected traumatic lesions in persons nine or more~     months of age. This study is designed to examine retapamulin use in the pediatric population~     less than nine months of age. We will conduct a five-year assessment of prescriptions for~     retapamulin using the General Practice Research Database. For each year of reporting, the~     observed frequencies of prescriptions of retapamulin, with or without same-day~     co-prescriptions of topical mupirocin or fusidic acid, will be identified. The five-year~     reporting period will include five years of distinct, non-overlapping, non-cumulative~     prescription use of first exposure to retapamulin, with or without same-day co-prescription~     of topical mupirocin or fusidic acid.~   "
184196|NCT01153815|"~     This trial is a multicenter, double-blind, randomized, placebo-controlled study to compare~     GSK1358820 (Botulinum Toxin Type A, also known as OnabotulinumtoxinA or Botox) with~     placebo on the efficacy and safety of treatment in poststroke subjects with focal wrist,~     finger and in some cases, thumb spasticity. Approximately 168 subjects will be enrolled.~     Subjects will receive a single treatment session of intramuscular GSK1358820 (Botulinum Toxin~     Type A, also known as OnabotulinumtoxinA or Botox) '200U or 240U (if thumb spasticity is~     present)' or placebo in a randomization ratio of 1:1. The subjects will be observed until 12~     weeks post injection. Outcome measures include changes from baseline at every post injection~     visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and~     Global Assessment Scale. The primary efficacy endpoint is the change from baseline at week 6~     for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters~     will also be measured including adverse events, vital signs (pulse and blood pressure) and~     clinical laboratory tests (haematology, serum chemistry and urinanalysis).~   "
184216|NCT01153555|"~     This is a multi-center, prospective registry of patients with intermediate coronary lesions~     defined as a stenosis of 40-80% by angiography. Approximately 300 patients will be enrolled~     into the study at sites in the United States and Europe. There will be no follow up beyond~     hospital discharge in this study. A sub-group of 30 patients will undergo Adenosine MRI. The~     investigators hypothesize that Intravascular Ultrasound Radiofrequency (IVUS RF) anatomical~     criteria, such as minimal luminal area, plaque burden and virtual histology plaque type, can~     predict physiological ischemia by Fractional Flow Reserve (FFR).~   "
184217|NCT01153542|"~     The objective of this study is to evaluate the effects of VX-770 on Desipramine~   "
191697|NCT01055158|"~     The purpose of this study is to evaluate the effectiveness of a telephone-based, cognitive~     behavioral therapy intervention in the treatment of depression in adults diagnosed with HIV.~   "
184197|NCT01153802|"~     GSK1360707 is a potent re-uptake inhibitor of the neurotransmitters dopamine, norepinephrine~     and serotonin. This is a single dose PET study in healthy subjects.A final analyses of safety~     data following exposure to single oral doses, from the first time in human study, with~     GSK1360707 has demonstrated that the compound is well tolerated up to a dose of 150mg. This~     imaging study will be an open label, non-randomised PET occupancy study using healthy male~     volunteers. The degree and time course of DAT and SERT occupancy by GSK1360707 will be~     determined. The PK/PD relationship between plasma concentrations of GSK1360707 and DAT and~     SERT occupancy will be described.This protocol amendment includes the flexibility to split~     the total dose into two doses e.g. 120mg per day could be split into two doses of 60mg.~     Splitting the total dose is most likely required to maintain therapeutic occupancy on the~     transporters over the course of the day; in addition it is expected that splitting the dose~     may reduce effects on vital signs. Therefore collecting data following split dosing will~     enable best predictions of therapeutic doses to be progressed in subsequent clinical studies.~   "
184198|NCT01153789|"~     The eye movements of vergence allow binocular vision whatever the viewing distance or the~     body movements are and the perception of depth. Vergence dysfunction can lead to erroneous~     visual sensation of movements. In our daily life using screens (computer, game boys..) is~     increasing and this approach heavily the ocular vergence and can lead to symptoms if~     oculomotor and accommodative systems are dysfunctioning (Ped. Neurology 2000). Not knowing~     this pathology lead to inappropriate and expensive prescription CT scan or NMR. To evaluate~     the vergence performances just evaluation in static condition is currently available in~     ophthalmology departments. The CNRS laboratory (IRIS, FRE 3154) adapted a technic of eye~     movement recording to study ocular vergence in dynamic condition.~   "
184199|NCT01153776|"~     The purpose of this study is to find a non-invasive alternative (with using ECG gated~     64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in~     patients who had undergone arterial switch operation for transposition of the great arteries~   "
184200|NCT01153763|"~     BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and~     tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF~     mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and~     continue on treatment until disease progression, death, or unacceptable adverse event.~   "
184201|NCT01153750|"~     To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or~     metastatic cholangiocellular carcinoma.~   "
184202|NCT01153737|"~     This study investigated effectiveness of manual therapy (MT) with Electric Nerve Stimulation~     (TENS) to reduce pain intensity in patients with mechanical neck disorder (MND). A randomized~     multi-centered controlled clinical trial was performed in 12 Primary Care Physiotherapy Units~     in Madrid Region.~   "
184203|NCT01153724|"~     This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor~     fluconazole on the bioavailability of olodaterol~   "
184204|NCT01153711|"~     This clinical trial is intended to investigate a possible effect of the p-gp inhibitor~     ketoconazole on the bioavailability of olodaterol~   "
184205|NCT01153698|"~     an open, prospective, observational study to collect data on safety (major bleeding events)~     and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to~     dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement~     (THR)~   "
184206|NCT01153685|"~     This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011~     Season) in adults aged 18 to 60 years and over 60 years.~   "
184207|NCT01153672|"~     This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer~     receiving aromatase inhibitor (AI) therapy. Vorinostat may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Vorinostat may also help AI therapy work~     better by making tumor cells more sensitive to the drug~   "
184208|NCT01153659|"~     This will be a randomized, open-label, single-center, 3-way crossover study in healthy~     subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will~     consist of 3 study periods separated by a washout period of at least 7 days. Subjects will~     receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be~     discharged from the study on Day 6 of Period 3 after completion of discharge procedures.~   "
184209|NCT01153646|"~     This is a pilot study to determine the safety and feasibility of lentivirus-transduced T-cell~     immunotherapy in patients who have failed highly active anti-retrovirus therapy (HAART).~   "
184210|NCT01153633|"~     The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation~     Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared~     to control saline irrigation solution and inactive gel by showing a reduction in size over a~     12 week period.~   "
184211|NCT01153620|"~     The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04%~     when used as an antiseptic agent and to compare these with Ringers' solution in patients with~     acute traumatic wounds.~   "
184212|NCT01153607|"~     PET (positron emission tomography) imaging with BAY1006578 for investigation of diagnostic~     potential in probable Alzheimer Disease patients versus healthy volunteers and radiation~     dosimetry in healthy volunteers.~   "
184213|NCT01153594|"~     The objective of this study was to evaluate the relative effectiveness of quarterly Recovery~     Management Checkups (RMC) on long-term outcomes of adult chronic substance users over 4~     years.~   "
184214|NCT01153581|"~     This study is designed to determine the causes of orthostatic intolerance which occurs more~     commonly in women than in men. Orthostatic tolerance is the ability to remain standing up~     right for long periods of time, or to avoid dizziness when moving to standing from a seated~     or lying position.~   "
184215|NCT01153568|"~     Vitamin D is a hormone that is produced when sunlight is absorbed by the skin. Vitamin D~     insufficiency has been recognized as a problem in areas where sun exposure is limited,~     especially in the wintertime. In addition, the more pigmented the skin is, the less capable~     it is of utilizing sunlight to make vitamin D. Vitamin D plays an important role in helping~     the body absorb calcium and in building strong bones. It has also been shown to improve~     muscle function in the elderly. As we get older, our vitamin D levels in the blood go down~     and this may increase the risk for falls and fractures. If we can improve vitamin D status as~     we age, we may be able to improve muscle strength and decrease the risk of falls and~     fractures.~   "
184218|NCT01153529|"~     The long-term goal of this research project is to identify genes that contribute to or guard~     against developing posttraumatic stress disorder (PTSD) and to better understand how genes~     and life experiences work together to impact PTSD. Inherited traits are passed down from one~     generation to the next in genes. Genes contain molecules called DNA, which contain the~     information that determines our characteristics and carries instructions for constructing and~     operating our body. Most human diseases have an inherited element. In addition, we, the~     investigators, hope to learn about how genes and the other materials we find in participants'~     blood relate to other illnesses and behaviors.~      The goal of the feasibility project covered by this application is to test the possibility of~     conducting research on a large number of veterans in order to look at the association between~     genes and PTSD. We are inviting 1,000 OEF/OIF veterans to participate, of these, we are~     anticipating approximately 250 veterans who have served in Afghanistan and/or Iraq to~     participate in this study. Although 250 participants is our target enrollment, we plan to~     enroll all veterans included in our initial mailings who desire to participate. We do not~     anticipate this to exceed 500 individuals. This phase of the study is expected to last about~     one year. Specific aims are: 1. evaluation of sampling methods and participation rates; 2.~     field testing of assessment batteries including reliability and validity; and 3. evaluation~     of the proposed DNA collection and storage procedures.~   "
184219|NCT01153516|"~     The purpose of this study is to evaluate the mechanisms leading to rapid postoperative~     improvement in diabetes following Gastric By-Pass surgery for obesity.We will evaluate and~     compare the changes in glucose level, beta-cell function, and insulin resistance induced by a~     week of very low calorie liquid diet and those induced by a week of matched very -low calorie~     liquid diet occuring in the context of routine postoperative care following RYGB.~   "
184220|NCT01153503|"~     In this randomized, controlled, observer-blinded study we plan to evaluate ultrasound-guided~     transversus abdominis plane (TAP) block for postoperative pain management in patients~     undergoing abdominal hysterectomy.~   "
184221|NCT01153490|"~     Cannabis is the most used illicit substance in the United States. Previous studies suggest~     that atypical antipsychotics decrease the frequency and the amount of substance use in~     subjects with and without psychotic illness. So far, there are no controlled studies~     assessing the effectiveness of atypical antipsychotics for decreasing cannabis and other~     substance use in individuals with cannabis use disorders. The investigators postulate that~     the atypical antipsychotic quetiapine ER is an effective agent for improving substance use~     outcomes in subjects with cannabis use disorders. In this pilot study, the investigators will~     test this hypothesis in heavy cannabis users (i.e., individuals who are cannabis dependent~     and smoke three times or more per week). Because 50% of these heavy cannabis users report~     histories of psychotic experiences (i.e., attenuated positive symptoms) while smoking and are~     at risk for recurring psychotic symptoms, the investigators will focus this pilot clinical~     trial on this subgroup of cannabis users in order to increase the risk/benefit ratio of this~     study and target a population that may also benefit from the antipsychotic effect of~     quetiapine ER. Considering the lack of controlled studies assessing the efficacy of atypical~     antipsychotics in heavy cannabis users, assessing the effectiveness of an atypical~     antipsychotic medication on substance use and clinical outcomes in this population is~     critical for improving the prognosis of these individuals.~      Thus, the aims of this randomized, double-blind, placebo-controlled study are to assess the~     efficacy of an atypical antipsychotic (quetiapine ER) in 120 subjects with cannabis~     dependence, a recent history (within a year) of attenuated psychotic symptoms, and using~     cannabis 3 times or more per week for: (1) decreasing the use of cannabis and other~     substances; and (2) preventing the recurrence of psychotic experiences. The investigators~     will also assess the effects of quetiapine ER on craving and mood, and its tolerability. This~     project will be a 12-week, randomized, double-blind, placebo-controlled study with quetiapine~     ER and it will include a comprehensive assessment of symptoms, substance use, and side~     effects.~      This study will benefit the field by providing unique data on the relative efficacy and~     tolerability of treatment with atypical antipsychotics in heavy cannabis users with a~     vulnerability to psychosis. This study will be the basis for future studies assessing the~     long-term efficacy and tolerability of atypical antipsychotics in individuals with cannabis~     use disorders.~   "
184222|NCT01153477|"~     The purpose of this challenge grant is to conduct an initial test of a new, enhanced version~     of this protocol (telephone monitoring and counseling - enhanced, or TMAC-E), which has been~     modified to include the elements of our existing continuing care intervention plus~     patient-centered changes to boost patient involvement and community linkages. The~     investigators will recruit 150 cocaine dependent patients in publicly funded, community-based~     programs and randomize them to treatment as usual or the TMAC-E and follow them for 12~     months.~   "
184223|NCT01153464|"~     This protocol (a supplement to 805466) is to test whether our telephone continuing care model~     can be implemented successfully by real world publicly funded programs. Participants will~     be recruited from Philadelphia's Department of Behavioral Health - run drug programs. The~     investigators will train city telephone care managers to deliver our telephone continuing~     care intervention to patients in this program. The investigators will randomize 200 to~     receive this intervention or usual care and follow them for 12 months.~   "
184224|NCT01153451|"~     Specific Aims: (Study #1, funded by AHRQ, completed May 2011)~        1. To create an automatic notification system to prompt physicians of test results~          finalized after discharge.~        2. To evaluate the impact of this system on physician awareness of test results finalized~          after discharge.~      Hypothesis: Automatic email notification will improve physician awareness of test results~     finalized after discharge compared to usual care.~      Specific Aims: (Study #2, funded by CRICO, completed July 2012)~        1. To identify a cohort of discharged patients with potentially actionable results of tests~          pending at discharge (TPAD).~        2. To determine if automated email notification of the finalized results of potentially~          actionable TPADs affects the rate of post-discharge actions taken as documented in the~          electronic medical record (EMR).~      Hypothesis: Automated email notification of the finalized results of potentially actionable~     TPADs increases the rate of actions taken post-discharge.~   "
184225|NCT01153438|"~     The purpose of this study is to see how hormones that control blood sugar change in response~     to two different weight loss surgeries (gastric bypass and gastric banding). We believe that~     changes in a hormone called glucagon-like peptide-1 (GLP-1) may account for the greater~     improvement in blood sugar after certain types of surgeries. GLP-1 makes the pancreas release~     insulin, a hormone that lowers blood sugar. The study will consist of one screening visit and~     three study visits in which the glucose response will be measured after drinking a liquid~     meal: 1) Visit 1 (2-3 weeks before surgery); 2) Visit 2 (after 10% of body weight is lost);~     and 3) Visit 3 (5-10 days after Visit 2). Hormone levels will be measured during the three~     study visits. To see if the improvement in blood sugar after surgery is due to changes in~     GLP-1, we will block its effect on insulin release by giving either salt water or a~     medication that blocks the activity of GLP-1 during the two visits that take place after~     surgery (Visits 2 and 3).~   "
184226|NCT01153425|"~     The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology~     to evaluate the response to drug intervention involving two treatment arms of postmenopausal~     participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic~     acid (Reclast™) group.~   "
184227|NCT01153412|"~     Postural stability and balance are defined as the body's ability to return the body back to~     its equilibrium point when exposed to a perturbation. This exploratory project is based on~     the hypotheses that decreased balance (increased sway as measured by the center of pressure~     of the body during quiet standing) causes an increased risk of falls and osteopathic~     manipulative treatment can improve postural balance. To test these hypotheses, the~     investigators will investigate the kinematics (study of the way the body moves) of postural~     balance in two cohorts of healthy elders, those receiving manipulation and those not~     receiving manipulation. We hypothesize that OMT is effective to increase postural stability,~     balance.~   "
184228|NCT01153399|"~     The primary objective of the study is to collect epidemiological data on EGFR mutation status~     [M+(mutation positive), M-(mutation negative)] in a population of predominantly Caucasian~     ethnicity, and to correlate EGFR mutation status with clinico-pathological characteristics~     (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine~     the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics~     that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and~     non-adenocarcinoma).~   "
184229|NCT01153386|"~     This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5~     mg treprostinil diethanolamine tablet strengths in healthy volunteers.~   "
184230|NCT01153373|"~     The investigators study will use a randomized controlled design. Eligible and consenting~     participants will be randomly assigned to one of two conditions: (1) DARSSA Intervention~     condition, or (2) Minimal Intervention Control condition. All enrolled participants will~     undergo the DARSSA baseline assessment and will be interviewed immediately following their ED~     discharge to assess relevant outcomes, such as whether they were asked about substance use~     and given a referral during their visit. This is referred to as the post-visit interview. All~     risky substance users enrolled during all phases will be interviewed again at 1- and 3-months~     post-visit to assess substance use, treatment engagement, and other outcomes. The primary~     difference between the two conditions is that, for the DARSSA Intervention condition, the~     subjects will have their reports printed and will be given the option of receiving the~     dynamic referral, while for the Minimal Intervention Control condition the subjects will~     undergo the assessment and will receive the standard substance abuse treatment referral list~     currently in use clinically at each site. The number of assessments and interactions with~     research staff will remain equal between the two conditions, with the only difference being~     the active intervention of the DARSSA reports and referrals, and any counseling by healthcare~     providers this engenders. The remainder of this section describes each phase of the study and~     enrollment procedures.~   "
184231|NCT01153360|"~     This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to~     have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the~     effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone~     concentrations, hemodynamic variables and outcomes in patients undergoing OPCAB in a~     randomized, controlled trial.~   "
184232|NCT01153347|"~     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like~     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken~     together with another antidepressant.~   "
184233|NCT01153334|"~     Objectives: An investigator-initiated, double-blind, randomized, placebo-controlled,~     multi-center study to evaluate the efficacy of early intensive rosuvastatin therapy~     (rosuvastatin 40 mg for pre-PCI loading and 7 days post PCI and 10 mg daily thereafter)~     versus low dose conventional statin therapy (placebo for pre-PCI loading and rosuvastatin 10~     mg daily after primary PCI) on infarct size measured by cardiac MRI and clinical outcomes in~     STEMI patients undergoing primary percutaneous coronary intervention (PCI). Hypothesis: The~     infarct size in the early high dose rosuvastatin group is smaller than that of the control~     patients treated with low does conventional statin therapy.~   "
184234|NCT01153321|"~     The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of~     patients with mild COPD.~   "
184235|NCT01153308|"~     The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of~     bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric~     bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity~     and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular~     disease.~   "
184236|NCT01153295|"~     The study aims to investigate how to give the diagnosis of Irritable Bowel Syndrome.~      The investigators compare two parallel groups of primary care patients, in the age of 18-50~     years with gastrointestinal complaints where the GP suspects IBS. All included patients~     fulfil international diagnostic criteria (ROME III) and have no danger signals.~      Group 1: The diagnosis is based on the diagnostic criteria and few blod tests Group 2: The~     diagnosis is a diagnosis of exclusion after investigations with extended blod tests,~     examination for milk- and gluten intolerance, stoll for ova and parasites and scopy of the~     intestine.~      After receiving the diagnosis of Irritable bowel syndrome all patients are informed about the~     condition.~      The investigators follow the patients for 1 year. The investigators hypothesis is that the~     two investigation programmes (group 1 and 2)are equal with respect to the patients´ quality~     of life, symptoms and satisfaction and also with respect to finding of organic diseases.~   "
184237|NCT01153282|"~     Determine the characteristics of symptoms and functional impairment associated with~     chemotherapy induced peripheral neuropathy.~   "
184238|NCT01153269|"~     The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human~     Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus~     co-infected patients.~   "
184251|NCT01153074|"~     The purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas~     with devices originally developed for correction of cardiac septal defects deployed through~     bronchoscopic procedures.~   "
184252|NCT01153061|"~     Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac~     septal defects.~   "
184287|NCT01152606|"~     This is a single cohort observational safety study. All patients will be treated and~     monitored according to the local clinical practice. No additional procedures/patient visits~     in comparison with the usual clinical practice are planned for the study. Data will be~     collected from centre's medical records for up to 5 years or death.~   "
184239|NCT01153256|"~     Magnesium had an inhibitory effect on neuromuscular transmission and caused a decrease in~     muscle fiber membrane excitability. It reduces the amount of acetylcholine that is released~     at the motor nerve terminal by decreasing the calcium conductance of presynaptic~     voltage-dependent calcium channels. After pre-treatment with magnesium, an increased speed of~     onset and a prolongation of the recovery period of neuromuscular blockade have been observed~     with other non-depolarizing neuromuscular blocking agent (NMBA) such as atracurium,~     vecuronium and rocuronium. Rocuronium is the currently preferred NMBA used as an alternative~     to succinylcholine for rapid tracheal intubation. As an alternative to succinylcholine, high~     doses of NMBA have been tested for rapid sequence intubation. This excessively high dose of~     rocuronium, however, prolongs the duration of the neuromuscular block and this may not be~     warranted in every surgical setting.~      The reduction of onset time of rocuronium by magnesium pre-treatment can make intubation~     condition more rapid and much better clinically. It will thus be interesting to compare~     intubation conditions of a standard intubation dose of rocuronium after magnesium~     pre-treatment with high dose of rocuronium or standard dose of rocuronium.~   "
184240|NCT01153243|"~     Recent clinical trials in non diabetics showed that vitamin D supplementation markedly~     reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix~     metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in~     African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of~     inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.~   "
184241|NCT01153230|"~     The purpose of this study is to determine frequencies of histo-pathological findings in dead~     poisoned patients and evaluate their relationships with age, gender, dosage of poisoning,~     time of admission and time of death.~   "
184242|NCT01153217|"~     Most of studies have not found any consistent drug-specific association with bone loss and~     controversial data with respect the effect of protease inhibitors (PIs) have been published.~     The more evident finding with respect to this issue is the more pronounced decrease of bone~     mineral density (BMD) in patients during the first weeks of receiving a tenofovir~     (TDF)-containing regimen, probably by the effect of TDF on phosphorus balance and vitamin D~     metabolism.~   "
184243|NCT01153204|"~     Context and Objectives: Erectile dysfunction severely compromises not only sexual~     satisfaction, which is well known to be closely linked to overall life satisfaction but is~     also associated with a lower quality of life, lower self-esteem, depression, anxiety and~     adverse effects on interpersonal relationships. The objective was to assess the efficacy of~     psychotherapy and/or sildenafil for psychogenic erectile dysfunction.~      Design and Settings: randomized controlled single-blind trial performed at Institute of~     Psychiatry of the Medical School of at Universidade de São Paulo, São Paulo, Brazil Methods:~     Thirty patients with mild and moderate psychogenic erectile dysfunction (ED) were randomized~     to receive for six months: group psychotherapy (GP) plus 50mg sildenafil on demand, or 50mg~     sildenafil exclusively, on demand, or GP exclusively. Changes in score from baseline for~     three questions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were~     evaluated at end-point and after 3-months follow-up.~      Results: satisfaction with the treatment, confidence and naturalness increased in GP plus~     sildenafil and GP exclusively groups (p=0.001) from baseline to endpoint. The~     treatment-by-time comparison was not significant at end point versus 3-month follow-ups, in~     the three groups. No difference was observed in the sildenafil group in the three study~     periods (P >0.05) Conclusions: Patients with mild and moderate psychogenic ED had higher~     treatment satisfaction, confidence and naturalness in engaging in sexual activity when~     receiving GP plus sildenafil or GP exclusively, when compared with sildenafil exclusively, as~     assessed by these three EDITS questions after 6-months treatment~   "
184244|NCT01153191|"~     The purpose of this study is to evaluate two different simple and inexpensive extra~     treatments during colorectal surgeries to see if this will reduce the rate of post operative~     infections~   "
184245|NCT01153165|"~     Purpose and design: The relationship between psychological morbidity and asthma has been~     previously recognised, however there is little evidence regarding the link between poor~     mental health and asthma control in people with severe asthma. If evidence was available~     showing that identifying and treating depression, resulted in meaningful improvements in~     people's asthma symptoms, this would be helpful in changing doctors' approach to people with~     severe asthma, ensuring that both physical and mental wellbeing were considered.~      This study will be a double blind randomised placebo controlled pilot study which aims to~     identify; if treating depression in patients with well characterised refractory asthma~     improves depression and asthma control. Forty patients who meet the inclusion criteria will~     be randomised to either a placebo or anti-depressant medication group, neither the~     participant nor the researcher will be aware of which medication they are given. Patients~     recruited will have severe asthma; will be identified as having depression using two~     validated questionnaires and will agree to take part and to take anti-depressant medication.~     Patients with poor adherence to medication, other respiratory conditions and who have had~     anti-depressant medication in previous the 6 months will be excluded. Outcome measures such~     as depression questionnaires, quality of life questionnaire, lung function, measures of~     airways inflammation and reduction in dose of oral steroids will be used to determine the~     effect of anti-depressant medication on depression and asthma control. The treatment period~     will be 12 weeks with outcomes assessed in the first and final week of treatment. The~     investigators hope to find out if the study protocol we have devised is feasible for a larger~     multi-Centre clinical trial and demonstrate some evidence that treating depression in~     subjects with well characterised refractory asthma will improve depression and asthma symptom~     control (this will be used to estimate the size of a larger clinical trial).~      Recruitment: Participants will be identified and approached by a member of their usual~     healthcare team and invited to participate. Participants will be given time to consider~     whether they wish to take part and will assured that their care will be unaffected should~     they choose not to participate or to withdraw during the study period.~      Inclusion/exclusion: All patients will be assessed using our well established systematic~     evaluation protocol. Refractory asthma will be based on the definition of the American~     Thoracic Society Consensus Workshop. Patients recruited will have refractory asthma, will be~     identified as having depression using two validated questionnaires and will agree to take~     part and to take anti-depressant medication. Patients with poor adherence to medication,~     other respiratory conditions and who have had anti-depressant medication in previous the 6~     months will be excluded.~      Consent: People who are unable to give informed consent will be excluded from the study as~     they may be particularly vulnerable. Capacity to give informed consent will be assessed by~     the participant's usual healthcare professionals.~      Risks, burdens and benefits~      There is a small risk of agitation and suicidal ideation associated with commencement of~     selective serotonin reuptake inhibition (SSRI) anti-depressants. The investigators will~     attempt to minimise this risk by:~        1. Contacting participants 1 week after commencing treatment and 1 week after any~          subsequent dose increase to ensure there is no suggestion of agitation or suicidal~          ideation. This is in accordance with the guidelines for initiation of SSRI therapy in~          adults.~        2. Participants will also be contacted weekly for 2 weeks after discontinuation of study~          treatment. If depressive symptoms worsen patients will be advised to liaise with their~          GP to consider institution of treatment on clinical grounds.~   "
184246|NCT01153152|"~     The purpose of this study is to determine whether pulp chamber opening and drainage on wisdom~     teeth with acute pulpitis before the extraction could reduce postoperative pain so beneficial~     to patient.~   "
184247|NCT01153139|"~     Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the~     treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may~     exert larger effects.~      This sham-controlled study examines the effectivity of daily bilateral TBS to the~     dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the~     local standard of a combined pharmacological/psychotherapeutical treatment.~   "
184248|NCT01153126|"~     This project evaluates the impact of CHESS-Mammo by assessing participants' health~     information competence, psychological distress, and satisfaction with their doctor as~     measured by previously validated survey questionnaires.~   "
184249|NCT01153113|"~     The purpose of this research is to develop a new and powerful type of immune therapy for~     prostate cancer patients. This therapy involves vaccinations with special stimulator cells~     found in the human body called dendritic cells. These dendritic cells can take up proteins~     released from cancer cells and present pieces of these proteins to immune cells called T~     lymphocytes to create a strong stimulatory signal to fight the cancer.~      One of these proteins is called telomerase, which is found on prostate cancers and is~     critically important for prostate cancer cells to grow. However, in most cancer patients, the~     immune system does not adequately destroy the tumor because the T cells are not stimulated~     sufficiently. T cells require strong stimulation before they grow and become active against~     cancer cells.~      We have discovered that substances called ribonucleic acids (RNA), which carry the genetic~     instructions for the production of telomerase, can be used to overcome this problem and~     stimulate a strong immune response in cancer patients.~      In order to test this hypothesis we have designed a clinical study and will enroll patients~     with metastatic prostate cancer expressing telomerase in order to determine whether or not~     this vaccine will stimulate T cells, which can recognize and kill prostate tumor cells.~      The main objectives of this study are to find out whether injections with dendritic cells~     grown from blood cells and pulsed (mixed together for a short period of time) with RNA~     derived from the patient's own tumor are:~        1. Safe without inducing any major side effects.~        2. And effective in boosting the patient body's immunity against telomerase expressing~          prostate cancer cells.~        3. Finally, we will test whether or not tumor shrinkage based on serum PSA levels or on~          X-ray studies will occur.~      We hope that this new form of immune therapy, although in its infancy, will ultimately slow~     down tumor growth and prolong survival of prostate cancer patients.~   "
184250|NCT01153100|"~     The investigators anticipate that the use of Glargine will decrease the duration of an~     insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care~     unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the~     insulin drip is discontinued.~   "
184288|NCT01152593|"~     The investigators believe that irradication of nose colonization of staphyloccocus aureus~     will reduce the incidence of surgical site infections after cesarean section.~   "
184253|NCT01153048|"~     The main objective is to assess impact of the establishment of involved patients (peer~     educators) network in Mali. It will be conducted by a multidisciplinary team that brings~     together high level skills in research projects and in peer education projects. It will be~     conducted in one country Mali. In the country, it will be completed in one site : the region~     of Sikasso. This site was chosen because It meet a functional care, access to medicines and a~     dynamic association of diabetic patients. Peer educators and persons targeted by the project~     will be recruited through Post-Test Club on diabetes (PTC). PTC will be a social support club~     that provides on going prevention counseling, education and support services to people who~     have diabetes. PTC represents an important link between patients, educators and general~     medical services. PTC will be defined as clubs, which are facilitated by well-trained peer~     educators, and will have 3 objectives: to provide social and emotional support to diabetic~     patients, to provide assistance in daily management and living with diabetes and to provide~     linkage to clinical care. To lead the sessions, in clubs, we will use a very innovative~     methodology for peer education: the learning nests method. To evaluate, we propose a~     classical randomized controlled experimental (RCT) design, with randomization at the~     person-level. For outcome measures, we propose change in HbA1c, increase of social and~     emotional support and increase of linkage to clinical care. In addition to HbA1c, we propose~     measuring changes systolic and diastolic blood pressure and weight.~   "
184254|NCT01153035|"~     The purpose of this study will be to evaluate, in a multi-center setting, the ability of~     radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the final~     negative margin and consequently decrease the rates of re-operation. During the initial~     breast conservation procedure (lumpectomy), immediately following routine surgical resection~     of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh~     lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the~     resected specimen.~   "
184255|NCT01153022|"~     Objective: To determine the effect of ankle joint mobilization on the alpha motoneuron reflex~     excitability of the soleus muscle in people with spasticity.~      Subjects and Methods: A controlled clinical trial with crossover design and simple masking~     was conducted in 24 randomized subjects to initiate the control or experimental group.~     Traction and rhythmic oscillation were applied for five minutes to the ankle joint. Alpha~     motoneuron reflex excitability was assessed by measuring H wave amplitude (Hoffmann reflex -~     H reflex), stimulating the tibial nerve at the level of the popliteal fossa and recording in~     the soleus muscle. In each subject 12 measurements were taken: basal rate, during and after~     mobilization. Changes in alpha motoneuron reflex excitability were calculated in relation to~     basal measurement. For each measurement a hypothesis test was performed (Student t test).~      Results: In groups of patients with brain injury (BI) and incomplete spinal cord injury~     (ISCI), a significant difference was found between measurements of both studies, concerning~     variation in alpha motoneuron reflex excitability during the application of joint~     mobilization techniques, with a decrease in the experimental group and an increase in the~     control group. In contrast, no significant differences were found after mobilization therapy.~     Patients with complete spinal cord injury (CSCI) showed no significant differences in any~     measurements.~      Conclusion: We demonstrate the effectiveness of passive movement in the decrease of muscle~     tone during the mobilization maneuver in patients with BI or ISCI, but no residual effect~     after completion of the trial. This research project showed no evidence regarding spasticity~     reduction in complete spinal cord injuries. This suggests that therapeutic interventions to~     decrease muscle tone, based on the passive exercise and stimulation of proprioceptors should~     be reconsidered.~   "
184256|NCT01153009|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     vortioxetine, once daily (QD), compared with placebo in adults with major depressive~     disorder.~   "
184257|NCT01152996|"~     The purpose of this study is to determine the long-term safety and tolerability of~     vortioxetine, once daily (QD), in participants with major depressive disorder.~   "
184258|NCT01152983|"~     The purpose of this study is to demonstrate the safety, performance and initial efficacy of~     the RapiDx device.~   "
184259|NCT01152970|"~     The provision of medical services in an inner city Emergency Department (ED) provides a~     critical opportunity to identify and characterize future timing and pattern of service use~     among youth with drug use, who may be missed in school-based samples, and who may not yet be~     in the criminal justice system. Currently, there is a paucity of data on the timing, pattern,~     barriers, and trajectory of youth with multiple risks (illicit drug use and ED visit for~     acute violence related injury) in terms of their intersection with health services (substance~     use treatment, mental health, medical) and criminal justice system, which limits the~     development of optimal timing and setting for interventions. Youth treated in the ED may have~     exacerbated rates of illicit drug use, and other risk behaviors (i.e. delinquency, HIV risk~     behaviors, weapon carriage) and different trajectories of outcomes and interactions with~     service use sectors based on presentation for intentional injury as compared to other~     complaints (medical, unintentional injuries). Understanding the outcomes and service~     utilization among inner-city youth with drug use with and without acute violent injury is~     critically important in developing prevention and treatment services to address these~     multiple risk factors. The investigators propose a prospective observational study over a~     two-year period to identify a high risk group of youth with past year illicit drug use~     (N=650) seeking care in an inner city ED. The specific aims of the study, chosen to obtain~     data necessary to determine the location and content of subsequent interventions, are: (1) To~     describe characteristics of youth (ages 14-24; n=650) who report illicit drug use presenting~     to an urban ED for an acute violent injury (n=350), compared to youth with drug use who seek~     non-violence related ED care (n=300), including demographic characteristics, problem severity~     (e.g., substance use, violence, HIV risk behaviors, etc.), enabling factors, and service~     utilization (i.e., substance use treatment, mental health, and medical); (2) To identify the~     trajectories of participants' interactions with health services during the two years~     following their ED visit and the key characteristics (i.e., predisposing, enabling, and need~     factors) associated with types of service use (substance abuse treatment, mental health, and~     medical/ ED) and barriers to these services; and, (3) To measure two-year outcomes for this~     cohort and to identify key demographic and clinical characteristics of youth with drug use,~     who have poor outcomes in the two years after ED visit for intentional injury and other~     medical care.~   "
184260|NCT01152957|"~     A study to examine the effectiveness of a multilevel Community Health Workers intervention as~     an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos in~     Miami.~   "
184261|NCT01152944|"~     The objective of this SAMMPRIS-affiliated study is to understand the mechanisms the~     mechanisms that underlie ischemic stroke recurrence in high-grade intracranial~     atherosclerotic disease in order to determine predictors of recurrent stroke. MoSIS will~     evaluate 6 specific mechanisms of stroke in the medically-treated SAMMPRIS cohort: decreased~     antegrade flow, progression of stenosis, decreased proximal collateral flow, decreased distal~     collateral flow, impaired cerebrovascular reserve, and artery-to-artery embolism.~   "
184262|NCT01152931|"~     In the last decade, the prevalence of malaria has been escalating at an alarming rate,~     especially in Africa. An estimated 300 to 500 million cases each year cause 1.5 to 2.7~     million deaths, more than 90% occur in children under 5 years of age in Africa (WHO 1995).~     Malaria is Africa's leading cause of under-five mortality (20%) and constitutes 10% of the~     continent's overall disease burden. It accounts for 40% of public health expenditure, 30-50%~     of inpatient admissions, and up to 50% of outpatient visits in areas with high malaria~     transmission. Antioxidant micronutrients have immunomodulatory role and may have suppressive~     activity.~   "
184263|NCT01152918|"~     This is a five-part study that will take place in the Bronx, NY, and Washington, D.C. The~     different components of the study will focus on increasing the number of people being tested~     for HIV, evaluating ways to link HIV-infected people to HIV care sites, evaluating methods to~     reinforce antiretroviral therapy (ART) adherence, and evaluating a counseling program that~     focuses on HIV prevention.~   "
184264|NCT01152905|"~     Background: Recent studies have questioned our previous understanding on the effect of~     nitrous oxide on muscle relaxants, since nitrous oxide has been shown to potentiate the~     action of bolus doses of mivacurium, rocuronium and vecuronium. This study was aimed to~     investigate the possible effect of nitrous oxide on the infusion requirements of~     cisatracurium.~      Methods: 70 ASA physical status I-III patients aged 18-75 years were enrolled in this~     randomized trial. The patients were undergoing elective surgery requiring general anesthesia~     with a duration of at least 90 minutes. Patients were randomized to receive propofol and~     remifentanil by target controlled infusion in combination with either a mixture of oxygen and~     nitrous oxide (Nitrous oxide/TIVA group) or oxygen in air (Air/TIVA group). A 0.1 mg/kg~     initial bolus of cisatracurium was administered before tracheal intubation, followed by a~     closed-loop computer controlled infusion of cisatracurium to produce and maintain a 90%~     neuromuscular block. Cumulative dose requirements of cisatracurium during the 90-min study~     period after bolus administration were measured and the asymptotic steady state rate of~     infusion to produce a constant 90% block was determined by applying nonlinear curve fitting~     to the data on the cumulative dose requirement during the study period.~      Results: Controller performance, i.e. the ability of the controller to maintain neuromuscular~     block constant at the setpoint and patient characteristics were similar in both groups. The~     administration of nitrous oxide did not affect cisatracurium infusion requirements. The mean~     steady-state rates of infusion were 0.072 +/- 0.018 and 0.066 +/- 0.017 mg * kg-1 * h-1 in~     Air/TIVA and Nitrous oxide/TIVA groups, respectively.~      Conclusions: Nitrous oxide does not affect the infusion requirements of cisatracurium.~   "
184265|NCT01152892|"~     The purpose of this study is to evaluate the use of non-invasive markers of the autonomic~     function and micro- and macrocirculation to predict mortality and cardiovascular end points~     in end-stage renal disease patients. Furthermore we aim at getting new insight into the~     insufficiently understood pathophysiology leading to excessively high cardiovascular and~     non-cardiovascular mortality in dialysis patients.~   "
184266|NCT01152879|"~     This study is being done to examine the effect of Parenteral (intravenous) nutrition support~     in the home setting on quality of life in cancer patients. In addition, this study is being~     done to examine the effect of home parenteral nutrition on the use of pain and anti-nausea~     medication.~   "
184267|NCT01152866|"~     With the development of the recombinant gonadotrophins, the use of human source proteins for~     the production of hormones has become unnecessary. These proteins, which are found in urinary~     preparations, have been thought to cause the local, post-injection adverse events (AEs) in~     some subjects.~      There has been a demand by physicians for an alternative to urinary products for treatment.~     Due to allergies to urinary products, or other personal reasons, subjects were not able or~     willing to be treated with proteins of human origin. This study allowed subjects to be~     treated with the recombinant human chorionic gonadotropin (r hCG) (free of urinary proteins),~     which otherwise would not be possible. The study sponsor used this opportunity to collect~     additional safety data on the new recombinant product, (Ovidrel, r-hCG).~   "
184268|NCT01152853|"~     In case of gastric cancer, the incidence of HER-2 positivity (2+, 3+ on IHC and/or FISH (+))~     is reported as similar as that of breast cancer, that is 22% of all cases. A recent ToGA~     Trial, phase III trial comparing trastuzumab combined with chemotherapy~     (fluoropyrimidine+cisplatin) versus chemotherapy alone in chemotherapy-naïve HER-2 (+)~     gastric cancer shows the significant benefit of using trastuzumab in terms of overall~     survival and progression-free survival. It provides the clinical evidence of HER-2 as a~     reasonable and potential therapeutic target in gastric cancer.~      Nowadays, lapatinib, HER-1 and HER-2 dual inhibitor, is also testing under the clinical trial~     in gastric cancer.~      In preclinical study, PF-00299804 is highly active in HER-2 amplified gastric cancer cell~     lines.(SNU preclinical data) So, we plan this phase II trial of PF-00299804 monotherapy in~     patients with HER-2 positive advance gastric cancer after failure of at least one~     chemotherapy regimen.~   "
184269|NCT01152840|"~     -  Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on~          mTOR inhibition by RAD001 has been systematically conducted in adenoid cystic carcinoma.~        -  In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response~          to RAD001 (unpublished data).~        -  So the investigators design this phase II study of RAD001 in adenoid cystic carcinoma to~          evaluate the efficacy of RAD001 in this orphan disease.~   "
184270|NCT01152827|"~     -  According to Martin F et al, AKT is highly phosphorylated in phenochromocytoma but not~          in benign adrenocortical tumors.~        -  In nonfunctioning carcinoid, the PI3K/AKT/mTOR pathway is activated.~        -  Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on~          mTOR inhibition by RAD001 have been conducted in pheochromocytoma or extra-adrenal~          paraganglioma or non-functioning carcinoid.~        -  So we design this phase II study of RAD001 in pheochromocytoma or extra-adrenal~          paraganglioma or non-functioning carcinoid to evaluate the efficacy of RAD001 in this~          orphan disease.~   "
184271|NCT01152814|"~     This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza~     vaccine administered to elderly subjects~   "
184281|NCT01152684|"~     The goal of The investigators community-based participatory research study is to identify the~     nature and extent of complementary and alternative medicine (CAM) use among HIV-positive~     Latinos on the San Diego/Tijuana border. CAM use among US Latinos living with HIV is~     associated with delayed utilization of and poor adherence to antiretroviral therapies (ARVs)~     that may exacerbate health disparities in HIV care access and health outcomes. This study~     will lead to development of culturally-effective interventions to improve access and~     adherence to HIV care in Latinos who face health disparities. The investigators hypothesis is~     that greater use of CAM will be observed among HIV-positive Latinos who report a) crossing~     the U.S. border more frequently, and b) having migrated to Tijuana or San Diego (e.g. from~     southern Mexico). The investigators also hypothesize that compared to HIV-positive Latinos~     who report using herbal CAM, those who do not use herbal CAM are more likely to be receiving~     ARVs and report higher levels of adherence to ARVs; Compared to HIV-positive Latinos who do~     not attend religious services regularly, those who attend religious services regularly are~     more likely to be receiving ARV; Compared to HIV- positive Latinos who report experiencing~     HIV related stigma, those who do not report experiencing HIV-related stigma are significantly~     more likely to be receiving ARVs.~   "
184272|NCT01152801|"~     This is an open-label, multi-center study to evaluate the safety of RAD001 in Chinese~     patients with metastatic renal cell cancer who are intolerant of or have progressed despite~     treatment with vascular endothelial growth factor (VEGF)-targeted therapies. All patients~     will be treated with RAD001 10 mg daily until tumor progression (determined according to the~     Response Evaluation Criteria In Solid Tumors (RECIST) Criteria), unacceptable toxicity, death~     or discontinuation from the study for any other reason. At least 60 patients will be enrolled~     in the study. Screening and baseline evaluations will be performed within 28 days of the date~     when the patient signs the informed consent form. Baseline evaluations will be performed~     within two weeks of the first dose of RAD001. Screening and baseline evaluations will be~     performed to determine if patient meets all inclusion and exclusion criteria. All eligible~     patients should be enrolled in the study and will receive the first dose of RAD001 (10 mg~     daily) on Day 1, Cycle 1. Subsequently, patients will be asked to come to the clinic every~     month to complete the protocol-specified evaluations. A treatment Cycle consists of 28 days.~     After discontinuation of treatment with RAD001, patients will have a safety follow-up~     performed 28 days after the last dose of RAD001. Patients must continue with survival~     assessments which will be performed every 3 months from the last dose of RAD001 until up to 2~     years after the last patient's first visit date.~      An interim analysis focusing on safety data and a final analysis of all data are planned. All~     patients still receiving the study drug at the time of the final analysis will be given the~     option to continue treatment with RAD001 until the occurrence of unacceptable toxicity or~     disease progression.~   "
184273|NCT01152788|"~     The purpose of this study is to find out what effects an experimental drug, called~     interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look~     promising compared to dacarbazine. In addition, this study will look at the side effects of~     rIL-21, and some special blood tests will be done to check the level of rIL-21 in the blood.~     This study will also look at previously removed melanoma tissue to determine which patients~     might benefit most from this treatment.~      This research is being done because currently there is no effective treatment for this type~     of cancer.~   "
184274|NCT01152775|"~     This study will investigate the potential impact of arts-informed, technology-based patient~     education material, and specifically, the role of multimedia imagery on patient~     comprehension, perceived satisfaction, anxiety levels, and informed decision-making.~   "
184275|NCT01152762|"~     Chronic Obstructive Pulmonary Disease (COPD) is a very important public health problem and~     one of the most common lung diseases in the world, with repercussions on mortality and high~     economic costs. The World Health Organization estimates that COPD is the fifth most common~     disease in the world and the fourth leading cause of death. It is expected to grow in~     prevalence and mortality over the coming decades; it is estimated that in 2020, it will be~     the third most common cause of death worldwide.~      Primary care is the main ambit in the management of these patients, in fact, it is where most~     patients with COPD are visited. However, a high proportion of these patients only receive~     chest physiotherapy treatment in hospitals, and the implementation of this kind of treatment~     in primary care is still very uncommon.~      Hypothesis: There is effectiveness on the quality of life and various predictive factors of~     mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index) and the~     economic impact of a Standardized Respiratory Physiotherapy program conducted in Primary Care~     (FREAP) in patients with moderate COPD at 6 months after its implementation.~   "
184276|NCT01152749|"~     This study examines the bioequivalence between an oral nicotine replacement product and~     Nicorette® gum.~   "
184277|NCT01152736|"~     Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.~   "
184278|NCT01152723|"~     Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette®~     gum.~   "
184279|NCT01152710|"~     A Phase II study aimed to evaluate the efficacy and toxicity of preoperative~     chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.~   "
184280|NCT01152697|"~     Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia~     and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%.~     Inadequate adherence is associated with poor outcomes such as relapse, homelessness,~     hospitalization, and increased health care costs. Studies have shown a direct correlation~     between non-adherence and rates of relapse in schizophrenia; on average, non-adherent~     patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A~     major obstacle to good outcomes in the maintenance treatment of patients with severe mental~     illness is difficulty with medication routines on an on-going basis. For this reason,~     long-acting injectable antipsychotic medication is a particularly attractive treatment option~     for populations with schizophrenia and schizoaffective disorder, although it is unlikely that~     medication treatment alone is likely to modify long-term attitudes and behaviors.~      This prospective study is a pilot analysis of a combined approach which merges a psychosocial~     intervention to optimize treatment attitudes towards psychotropic medication (CAE) and~     long-acting injectable antipsychotic medication (L) in recently homeless individuals with~     schizophrenia or schizoaffective disorder who are known to have on-going difficulties with~     treatment non-adherence. It is expected that this combined approach (CAE-L) will improve~     illness outcomes among the most vulnerable of populations with schizophrenia or~     schizoaffective disorder.~   "
184282|NCT01152671|"~     This randomized, double-blind, placebo-controlled study will assess the safety, tolerability~     and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be~     randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10~     days.~   "
184283|NCT01152658|"~     The objective of this clinical trial is to evaluate the impact and symptomatic efficacy of~     platelets rich plasma (PRP \ PRGF) in the treatment of partial tears of supraspinatus tendon~     of rotator cuff.~      Speed of tendon healing of partial thickness tear of the supraspinatus tendon influenced by~     local injection of platelets rich plasma~   "
184284|NCT01152645|"~     A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy~     in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint~     is disease control and the secondary efficacy endpoints include antitumor effect (tumor~     response), progression-free survival and overall survival. The pharmacokinetic profile and~     the safety profile are also evaluated.~   "
184289|NCT01152580|"~     Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10~     million individuals have osteoporosis and 34 million more have low bone mass or osteopenia,~     which places them at an increased risk of some day developing osteoporosis. Of the people~     affected by this problem, 68% are women.The current thinking on the development of~     osteoporosis is that the changes in bone turnover that occur with aging play a major factor.~     Many modalities of treatment are used to prevent the bone loss and increased fracture risk~     associated with osteoporosis and osteopenia. Melatonin supplementation may be another~     treatment modality that lowers risk of hip fracture in perimenopausal women. Melatonin can~     remodel bone in animal models and in culture. Melatonin works through melatonin receptors to~     form osteoblasts from human mesenchymal stem cells and has been shown to inhibit osteoclast~     activity in rodents. Melatonin levels have been correlated with modulating bone markers; low~     nocturnal levels of melatonin correlate with in an increase in bone marker metabolism and~     osteoporosis. It is been shown that women who have worked night-shifts for greater than 20~     years have increased risk for wrist and hip fractures. Night-shift workers have lower~     nocturnal melatonin levels than people who do not work the night-shift. The addition of~     exogenous melatonin suppresses bone marker metabolism. In human stem cells taken from bone~     marrow, melatonin increases the activity of bone-forming cells called osteoblasts. It is~     hypothesized that melatonin will improve bone health, menopausal quality of life and sleep~     compared to placebo in perimenopausal women. In particular, the investigators expect~     perimenopausal women taking melatonin to show an improvement in overall bone health as~     revealed by a reduction in bone marker turnover since bone resorption increases more so than~     bone absorption in this population compared to those women taking placebo. We also expect~     that perimenopausal women taking melatonin to have better control over their menopausal~     symptoms, better quality of life and less sleep disturbances when compared to their placebo~     controls since melatonin is known to modulate estrogen levels in the body and regulate sleep.~     The data from these studies may provide novel and alternative uses for melatonin; in~     particular its use for the prevention and/or treatment of osteoporosis.~   "
184290|NCT01152567|"~     The planned Study will be a retrospective study on the effect of ACE's vs. candesartan on~     cardiovascular events and on health economic effects in a real life setting in Sweden.~   "
184291|NCT01152554|"~     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like~     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken~     for 52 weeks with another antidepressant medicine.~   "
184292|NCT01152541|"~     Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing~     progression of both keratoconus and corneal ectasia after surgery, as well as possibly~     decreasing the steepness of the cornea in these pathologies. During the CXL procedure, the~     central corneal thickness has been shown to significantly change. The investigator's believe~     that better maintenance of corneal thickness potentially could have benefits of better~     reproducibility of the crosslinking effect with improved predictability of results.~   "
184293|NCT01152528|"~     The purpose of this study is to determine whether screening of pregnant women with history of~     previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment~     of positive women will reduce the risk of spontaneous preterm birth. We will compare between~     the effectiveness of once a week screening and once during pregnancy screening.~   "
184294|NCT01152515|"~     Tracheal extubation can be associated with hyperdynamic circulatory response. The~     investigators examined the effect of maintaining a remifentanil infusion on the~     cardiovascular response during extubation in propofol-remifentanil sedated patients after~     surgery.~   "
184295|NCT01152502|"~     Follow-up of urinary concentration from paracetamol metabolites by patients with aortic~     surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)~   "
184296|NCT01152489|"~     The hypothesis of this study is that distraction cards used by the caretaker along with a~     vibrating cold pack placed proximal to the site of immunization will decrease the pain of~     routine pediatric immunizations when compared to a placebo device or standard care.~   "
184297|NCT01152476|"~     Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused~     more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%.~     Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is~     used with remifentanil in pediatric general anesthesia.~   "
184298|NCT01152463|"~     Lung cancer remains the leading cause of mortality from malignant diseases in both men and~     women worldwide. Following thoracic surgery and pulmonary resection, patients have a~     surgically induced pneumothorax / hydro-hemothorax and hence tube thoracostomy is necessary~     to drain the air and effusion. Due to this, patients must undergo post-operative chest x-ray~     (CXR) evaluations in order to evaluate the chest and make decisions regarding removal of~     chest tubes (CT) as well as for decisions regarding patient discharge. Thoracic Ultrasound~     (US) has been shown to be accurate at diagnosing pneumothorax and has been well-studied in~     the trauma population. To the investigators knowledge, there are currently no centers using~     thoracic US routinely in the post-operative setting following thoracic surgery.~   "
184299|NCT01152450|"~     Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety~     of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for~     the compliance and convenience of the patient in comparison to placebo. Further the rationale~     is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by~     the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily~     (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent~     asthma.~      Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to~     tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once~     daily (in the evening) or 2.5 µg tiotropium twice daily.~   "
184300|NCT01152437|"~     This Phase II study is open to patients with metastatic colorectal cancer who have tried but~     failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have~     received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab,~     panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral~     oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or~     cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all~     receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW~     2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the~     effectiveness of BIBW 2992 in patients with KRAS mutated cancer.~   "
184301|NCT01152424|"~     Acute eosinophilic pneumonia (AEP) is diagnosed by cell count analysis of bronchoalveolar~     lavage fluid. However, the performance of bronchoscopy is not easy for patients with AEP,~     because they usually have hypoxia. Exhaled nitric oxide (FeNO) is usually elevated in the~     patients with eosinophilic inflammation such as asthma, but there is no previous studies FeNO~     in the patients with AEP. Investigators hypothesized that FeNO elevated significantly in~     patients with AEP, and FeNO can be used as non-invasive diagnostic method in patients who are~     clinically suspected with AEP, especially when the performance of bronchoscopy is difficult.~   "
184302|NCT01152411|"~     Chronic renal failure (CRF, or chronic kidney failure, CKF, or chronic kidney disease,~     CKD) is a slowly progressive loss of renal function over a period of months or years and~     defined as an abnormally low glomerular filtration rate, which is usually determined~     indirectly by the creatinine level in blood serum.~      CRF that leads to severe illness and requires some form of renal replacement therapy(such as~     dialysis) is called end-stage renal disease (ESRD). While renal replacement therapies can~     maintain patients indefinitely and prolong life, the quality of life is severely affected.~     Renal transplantation increases the survival of patients with stage 5 CKD significantly when~     compared to other therapeutic options; however, it is associated with an increased short-term~     mortality (due to complications of the surgery).~      In view of the above, there is definitely an urgent need for finding different methods of~     treatment for these patients who cannot undergo established modalities of treatment or these~     have been tried unsuccessfully hence the inadequacy of current treatment modalities and~     insufficiency of donor organs for transplantation have driven a search for improved methods~     of dealing with renal failure. The rising concept of cell-based therapeutics has provided a~     framework around which new approaches are being generated, and its combination with advances~     in stem cell research stands to bring both fields to clinical fruition. Since CRF affects a~     large number of these patients who will lose their productive life, stem cell implantation~     can offer some promise of improved health.~      In our present study, we want to evaluate the safety and efficacy (to know / observe for~     Proof of concept in five indian patients) if any, of autologous bone marrow derived stem~     cells injected into the Renal Artery in five (initially five patients, can be increased to~     ten patients after observing the initial results) patients with Chronic Renal Failure.~   "
184303|NCT01152398|"~     The current trial, BNIT-BR-003, will evaluate the safety and biological activity of a fixed~     dose of MVA-BN®-HER2 following adjuvant chemotherapy in patients with HER-2-positive breast~     cancer.~      The intent of vaccination is to induce a combined antibody and T-cell anti-HER-2 immune~     response, which is intended to target HER-2-expressing tumor cells, and may induce tumor~     regression or slow progression of disease.~   "
184304|NCT01152385|"~     The purpose of this study is to compare the effect on glucose control of 3 different AZD1656~     dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as~     evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.~   "
184305|NCT01152372|"~     Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects~     and those with type 2 diabetes mellitus~   "
184306|NCT01152359|"~     Obesity is increasingly common and can lead to decreased quality of life, increased medical~     and psychiatric illness, high health care costs, and early mortality. The problem of obesity~     is as great in veterans as it is in the general public. Adherence to dietary therapy for~     obesity is often inadequate, possibly because patients' food preferences are not considered~     during dietary counseling. Allowing patients to choose a diet based on their food preferences~     may increase their motivation to adhere to diet counseling. This, in turn, could enhance~     their weight loss success and, ultimately, reduce the many health complications and costs of~     obesity. The proposed study will examine whether assessing a person's food preferences, and~     then allowing the person to choose from two commonly prescribed diets, results in greater~     weight loss success.~   "
184307|NCT01152346|"~     The purpose of the study is to determine the bioavailability of Azacitidine for Injection~     relative to Vidaza® in MDS patients under fasting conditions. The data will be evaluated~     statistically to determine if the products meet bioequivalence criteria.~   "
184308|NCT01152333|"~     Scientists have discovered a number of hormones that control our feelings of hunger and~     fullness. One particular hormone, called GLP-1, has been associated with feelings of hunger~     and fullness. The overall purpose of this study is to look more closely at how GLP-1 changes~     these feelings and to observe how these hormones affect the brain's function. To do this,~     volunteers will be asked to come to the clinic for a screening visit, and 2 study visits.~     This is an outpatient study with a screening visit which will last about an hour and the two~     subsequent study visits for about 3 hours each. During the study, patients will receive a~     drug that blocks the effect of a hormone made in the gut. We will take a series of blood~     samples to measure hormones and use functional magnetic resonance imaging (MRI) to take~     pictures of the brain. Understanding the action of these hormones in the brain may eventually~     lead to new ways to help people avoid obesity or lose weight.~   "
184309|NCT01152320|"~     Spirometry is a recommended component of asthma diagnosis and treatment in the primary care~     setting, yet few primary care providers report routine use of spirometry in the provision of~     care for their asthma patients. Misclassification of asthma severity has been reported when~     assessment is based on symptoms alone. This misclassification can lead to inadequate~     treatment that may result in increased morbidity and increased healthcare utilization/cost.~     However, even when spirometry is utilized to aid in asthma severity classification, primary~     care providers have a high rate of failing to meet the quality goals for testing established~     by the American Thoracic Society.~      The goal of this study is to evaluate the effectiveness of the Spirometry Fundamentals™ tool~     in training primary care providers and their staff in producing high-quality flow-volume~     curves as compared to existing training modalities and to gather information in a~     'real-world' setting that can be used to improve Spirometry Fundamentals™.~   "
184310|NCT01152307|"~     The purpose of this randomized controlled trial is to examine the impact of a patient~     decision aid on the quality of decisions about managing symptoms of depression. In~     particular, we will examine whether the decision aid increases knowledge about~     depression/managing depression symptoms and concordance between goals and treatment choices.~   "
184311|NCT01152294|"~     The purpose of this randomized controlled trial is to examine the impact of a patient~     decision aid on the quality of decisions about managing symptoms of menopause. In particular,~     we will examine whether the decision aid increases knowledge about menopause/managing~     menopause symptoms and concordance between goals and treatment choices.~   "
184342|NCT01151891|"~     There are no evidence (research) based guidelines for treatment of early, closed puncture~     wounds of the feet in diabetics. Surgeons usually see only the limb- and life-threatening~     consequences of puncture wounds of the feet in diabetics, and are therefore tempted to~     advocate more aggressive, preemptive, invasive primary treatment for all such wounds,~     assuming, from this blinkered perspective that all such wounds progress to serious infection.~     This study is designed to determine the natural history of puncture wounds of the feet in~     diabetics, specifically, whether all become infected or whether some do heal without any~     surgical intervention. It requires administration of a questionnaire to 188 known diabetics~     attending 11 selected outpatient health care centers in the parish of St. James, Jamaica.~   "
184343|NCT01151878|"~     The purpose of this study is to determine whether administration of glucomannan (dietary~     fiber) is effective in treating functional constipation in children.~   "
184312|NCT01152281|"~     Unfortunately, people most at risk for HIV are the least likely to enroll and remain in~     prevention programs. In our past work, we have learned how to increase enrollment in such~     programs among this group. We have identified and addressed previously ignored~     gender-specific and client self-validation issues that conventional interventions often leave~     not only uncontrolled, but often biased against participation. The present work will extend~     these methods from enrollment to retention.~      We intend to recruit a sample of 656 at-risk participants through our collaboration with the~     Duval County, FL Health Department for our randomized, double-blind trial. Our study will~     investigate if a meta-intervention video designed for empowering participants as agents of~     their own change can increase the number of attended sessions relative to a control condition~     without such a video. This trial will also determine if a meta-intervention video addressing~     various emotional/social and instrumental benefits of an HIV-prevention-counseling~     intervention can also increase the number of attended sessions. These two factors will be~     crossed, and their effects on retention will be estimated for different genders and~     ethnicities. Effects on clients' attention to the return sessions as reported by the~     counselor will also be explored among participants who return.~      We will also conduct mediator analyses for investigating if the meta-intervention has~     mediating influences on corresponding expectations about the return counseling session. As~     the inclusion of meta-cognitive measures can alter the efficacy of the intervention, half of~     the sample will receive measures immediately (0-10 minutes) after exposure to the~     meta-intervention, before attendance to the next session is registered. The other half will~     not complete these measures.~   "
184313|NCT01152268|"~     Despite the known adverse effects of specific cancer treatments on fertility, only 18-26% of~     at-risk adolescents and young men cryopreserve sperm prior to cancer treatment in the US:~     These already less than optimal rates of sperm banking are even lower among adolescents who~     have increased anxiety at cancer diagnosis, are lower in age and socioeconomic status, of~     Evangelical religious orientation, or are diagnosed with leukemia/lymphoma: It is not clear~     why sperm banking is underutilized, particularly in light of the high priority that survivors~     of childhood cancer place on fertility and the high psychological distress associated with~     fertility loss. Studies addressing sperm banking among adults with cancer suggest that~     factors such as poor physician communication and the resulting lack of fertility-risk~     knowledge by patients contributes to the low frequency of sperm cryopreservation. No~     well-designed studies have examined risk factors associated with failure to bank sperm among~     adolescents with cancer, a developmentally distinct population ripe for intervention.~      This study plans to enroll 206 adolescent males and 412 parents/guardians.~   "
184314|NCT01152255|"~     This study will evaluate the safety and tolerability of MK6186 and the change from baseline~     in plasma HIV-1 RNA after seven consecutive days of dosing.~   "
184315|NCT01152242|"~     The purpose of this study is to evaluate whether the within-subject variation in duration of~     action and time-action profile of glargine measured by isoglycemic clamp will be below~     prespecified levels.~   "
184316|NCT01152229|"~     The objective is to describe and quantify levels of platelet reactivity in three different~     cohorts of patients taking thienopyridine: patients who report nuisance bleeding, patients~     who report alarming bleeding, and patients who report no nuisance or alarming bleeding. The~     investigators hypothesize that patients with nuisance or alarming bleeding events on~     maintenance thienopyridine therapy will have lower levels of platelet reactivity than~     patients without nuisance or alarming bleeding on thienopyridine therapy.~   "
184317|NCT01152216|"~     An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of~     dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on~     Donepezil.~   "
184318|NCT01152203|"~     The goal of this clinical research study is to find the highest tolerable combination dose of~     bendamustine and bevacizumab that can be given to patients with advanced cancer. The safety~     of the drug combination will also be studied.~   "
184319|NCT01152190|"~     The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for~     8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of~     Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate~     transition zone.~   "
184320|NCT01152177|"~     The aim of this project is to evaluate the efficacy of electronic reminder letters versus~     none on general practices adherence to clinical quality guidelines regarding Point Of Care~     Testing (POCT). The investigators hypothesize, that electronic reminder letters may increase~     adherence.~   "
184321|NCT01152164|"~     The goal of this study is gathering informations about patients' quality of life after~     combined modality treatment of rectal cancer to evaluate how combined modality treatment for~     rectal cancer affects patients' quality of life. The findings of this study may provide us~     important information that can be used in treatment decision and to develop programs to~     improve quality of life of patients with rectal cancer.~   "
184322|NCT01152151|"~     The aim of this project is to evaluate the efficacy of electronic reminder letters versus~     postal reminder letters on general practices adherence to clinical quality guidelines~     regarding Point Of Care Testing (POCT).~   "
184323|NCT01152138|"~     The aim of this study is to determine whether a closed cell stent design may reduce distal~     embolization and no reflow during primary percutaneous coronary intervention (PPCI) for acute~     ST-elevation acute myocardial infarction (STEMI) compared to an open cell stent design. The~     study population will include all consecutive patients admitted for acute STEMI and treated~     with PPCI within 12 hours from symptom onset.~   "
184344|NCT01151865|"~     The primary aim of the DahLIA trial is to determine, in patients with ICU-associated delirium~     and agitation who are otherwise pathophysiologically stable (as defined), the number of~     ventilator-free hours in the incident ICU admission in the 7 days following commencement of~     trial medication, in patients randomised to receive dexmedetomidine or placebo while~     receiving all other aspects of standard care.~      The null hypothesis assumes no difference in the median number of ventilator-free hours in~     this ICU admission in the following 7 days, between patients receiving dexmedetomidine and~     placebo for ICU-associated agitation and delirium.~   "
184345|NCT01151852|"~     The objective of this study is to compare the clinical outcomes following resumption of~     dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best~     supportive care in patients with advanced/incurable Gastrointestinal Stromal Tumors following~     failure of prior imatinib and sunitinib therapies.~   "
184324|NCT01152125|"~     Osteoarthritis is a leading cause of chronic disability in elderly and the risk of disability~     attributed to osteoarthritis is as great as or greater than due to any other medical~     condition in that age group. Several cross sectional studies have demonstrated an age related~     increase in the prevalence of osteoarthritis of knee(5). Results of survey are similar with~     most surgeons reporting 50+ years age group being commonest at initial presentation and that~     the incidence increases with advancing age. Interestingly some surgeons have noticed earlier~     occurrence of osteoarthritis in 40+ years age group and one has to be careful to screen for~     secondary causes in this younger age group patients.~      While pain relief is the primary treatment goal of osteoarthritis medications, localized~     inflammation may also be relieved by using certain drugs. Managing osteoarthritis pain can~     involve medications, natural remedies, exercise, weight loss, joint protection, mobility~     aids, assisted devices and more.~      Stem cell therapy, using cells extracted from the same patient or suitable alternative human~     sources, targets diseases which are either incurable or with no complete or effective~     treatment available in the traditional healthcare system. Since this therapy is based on the~     concept of regenerating damaged cells in the injured or disease-affected areas of the body,~     it is called regenerative medicine~      Autologous stem cells provide an attractive option for osteoarthritis patients and their~     clinicians.~      In our present study we want to evaluate the safety and efficacy of autologous bone marrow~     derived stem cells in treatment of Osteoarthritis for therapeutic chondrogenesis through~     delivery of stem cells into the knee joint space in ten Indian patients.~   "
184325|NCT01152112|"~     The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue~     Removal System when used by community gynecologists in an office setting for the treatment of~     patients with symptomatic intrauterine polyps and submucosal fibroids.~   "
184326|NCT01152099|"~     Hypothesis:~      To know the utility of manual lymph drainage (MLD) as part of the Physical Complex Therapy~     has turn out relevant because of the exclusive dedication that it supposes to the therapist.~     To date, the evidence-base for MLD is very limited and only two studies analyze its~     relevance. The first study measured the effect of compression bandage with or without MLD.~     The group receiving compression and MLD had a significant reduction in limb volume and~     decreased pain, despite the fact the MLD was given only for one week (Johansson et al.,~     1999). A further study investigated the effect of eight sessions of MLD over two weeks in 42~     women with breast cancer-related lymphoedema, and the findings suggested that MLD do not~     contribute significantly to oedema reduction, although the MLD course was relatively short~     and the study group was limited to those with mild to moderate swelling (20-30 % of~     difference). Information about the quality of life, using the questionnaire EORT QLQ-C30 was~     gathered but the results were not considered in the final assessment (Andersen and Cabbage~     2000).~      Similar studies would provide comparative and enlightening information with regard to the~     previous results. The investigators could determine if the MLD, in spite of not obtaining an~     improvement in the volume of the lymphoedema, provides a benefit in the reduction of the~     symptoms related to it.~      The investigators hypothesized that MLD does not contribute significantly in volume limb~     reduction but it provides a clinical improvement regarding the quality of life according to~     the questionnaire EORT QLQ-C30.~      For the calculation of the sample size the investigators depart from the following~     assumptions:~      The effect of the standard treatment on the control group control will produce an average~     volume limb reduction of 5 %.~      The effect of the treatment in the experimental group will be an average of the 25 % (a minor~     difference of effects would indicate a discreet effect of the tested treatment). The~     investigators also assume that, the standard deviation will be similar in both groups and~     near to 25 %. With this information and for an alpha risk of 0.05 and a power of 0.80 the~     calculation of the sample size is 20 patients in every group. Considering a rate of~     withdrawal of 30 % in every group, the appropriate sample size is 58 patients assigned in two~     groups of 29 patients.~      Main aim:~      To analyze the effectiveness of Manual Lymph Drainage (MLD) in the treatment of~     postmastectomy lymphoedema in order to reduce the volume of lymphoedema~      Secondary aims:~      To analyze the duration of the reduction of the lymphoedema in the time. To analyze the~     improvement in the concomitant symptomatology of the lymphoedema using the results of two~     quality of life tests validated in Spanish: EORTC QLQ-C30 version 2.0, for the cancer in~     general and EORTC QLQ-BR23 specifically for the breast cancer. In particular, the items~     refering to the upper extremity (47, 48, 49) and to the corporal image (39, 40, 41, 42) and~     in which the higher the score the worse the result.~      Methodology:~      Researching Project with methodology of randomized, controlled clinical trial. Group A or~     Control: patients with standard treatment (care the skin, exercise and measures of~     compression -bandage for one month and later a sleeve of compression).~      Group B or Experimental: patients with standard treatment (care of the skin, exercise and~     measures of compression (bandage for one month and later a sleeve for lymphoedema) and in~     addition they receive Manual Lymph Drainage Main variable: Volume reduction of the affected~     arm after the treatment expressed in percentage.~      Number of patients: 58 women.~   "
184327|NCT01152086|"~     Suicide is a major public health issue with estimated 1 million deaths worldwide within the~     last year. Physical activity and nature recreation might be protective factors against~     suicidal behaviour, suicidal ideation and contributing factors like depression and~     hopelessness.~      In this randomized controlled cross-over intervention study the investigators aim to~     investigate the physical and psychological effects of a 9 weeks hiking program in chronically~     suicidal patients. The investigators aim to enroll 24 patients suffering from chronic~     suicidality, defined as at least one attempted suicide and a hopelessness greater than 26 in~     Beck's Hopelessness Scale summary score. At baseline patients will undergo pre-tests~     including questionnaires to assess suicide ideation, hopelessness, depression, anxiety,~     quality of life and health-related physical activity, physiological investigations to assess~     exercise capacity and blood investigations. Randomly assigned 12 patients start with the 9~     weeks supervised mountain hiking program followed by a 9-week-period without supervised~     exercise program. The other 12 patients start with 9 weeks without supervised exercise~     program followed by a 9-week-period of supervised mountain hiking program. The mountain~     hiking program includes 2 training sessions per week with a duration of 3 hours per session.~     The hiking intervention will be performed within 70-85% of heart rate reserve and gymnastics~     for body and nature perception, mobilisation and stretching will enrich the training program.~     Further investigations including questionnaire-assessments, assessment of exercise capacity~     and blood investigations will be scheduled 9 and 18 weeks after the study start. In addition~     a daily assessment of several suicide risk-factors based on a web-based questionnaire will be~     done over the full study period. Within this mountain hiking program the investigators hope~     to reduce hopelessness in chronically suicidal patients.~   "
184328|NCT01152073|"~     Great controversy exists about the feasibility and safety of a product that can be employed~     for self-directed cholesterol reduction. The position that self-directed cholesterol lowering~     could lead those that do not need lower cholesterol to take the product is likely unfounded.~     This is because there is no convincing evidence to suggest that there are cholesterol levels~     so low that a lower one would not be beneficial or conversely be dangerous. Ample evidence~     exists that cholesterol causes cardiovascular disease and that lower cholesterol places~     individuals and populations at lower risk. Because of the high cost, insurance concerns and~     suboptimal access to physician care, a self-directed, effective and safe approach to~     cholesterol maintenance or reduction would be very desirable. Drug therapy also has been~     associated with suboptimal results. Though a new concept that addresses cholesterol by~     several mechanisms simultaneously has been shown to be more consistently effective and with~     better tolerability, there is still a need for a self-directed cholesterol optimizing~     alternative. It is, therefore, our intent in this study to evaluate certain foods,~     specifically nutraceutical containing fruit flavored drinks in the hopes that they can be~     proven a safe and effective alternative approach for cholesterol management.~   "
184329|NCT01152060|"~     Lamivudine treatment for HBV-DNA negative HBV-GN patients.~   "
184330|NCT01152047|"~     The investigators have seen that oxytocin lowers satiety in healthy subjects. Patients with~     dyspepsia suffers from decreased accommodation and increased satiety postprandially. The~     investigators now want to examine whether oxytocin may diminish symptoms in these patients.~   "
184331|NCT01152034|"~     This study aims to develop the MAPS(M,Monitoring;A,Assessing;P,Preventing or Reducing~     Relapse;S,Smart goal setting) group therapy model for bipolar disorder patients as other~     adjuvant clinical treatment and develop the instruments for evaluating the severity of~     bipolar symptoms. The investigators insist to provide the psychosocial intervention for~     bipolar patients in the general hospital and offer appropriative adjuvant intervention except~     current psychiatric biological treatment.~      This study is a one-year project. First, the investigators like to translate the Depression,~     Anxiety and Stress Scale (DASS) and the Altman Self-Rating Scale for Mania (ASRM) to Chinese~     and finish the reliability and validity study. Second, the investigators would like to~     develop the MAPS group therapy to enhance bipolar patients' insight, increased life quality~     and decrease suicidal ideation. This study is a case control study. All cases recruit from~     the psychiatric outpatient department of one medical center. The inclusion criteria are~     diagnosed as bipolar disorder, age from 18 to 65 and agree to sign the inform consent. The~     excluded criteria are hard to communicate, with acute psychiatric feature and severe physical~     illness. The investigators plan to hold the MAPS group three times and predetermine to~     recruit totally 30 patients as the case group. As to the control group, the investigators~     also recruit from the psychiatric outpatient department and those who treat as usual by~     control their gender, age and the same diagnosis as bipolar disorder. The only one different~     factor between the case group and the control group was attending the MAPS group therapy or~     not. In MAPS group therapy, two facilitators work with ten clients with twelve weekly~     sessions and three monthly booster sessions. Self-report rating scales (DASS and ASRM) are~     completed at the beginning of each session. The investigators use DASS and ASRM to evaluate~     the severity of bipolar symptoms; BSS for suicidal ideation; SF-36 for life quality. The~     hypothesis is patients attended to MAPS group therapy have better symptoms control, lower~     suicidal ideation, better life quality and less use emergency department or admissions than~     those who didn't attend the group therapy.~   "
184332|NCT01152021|"~     This is a prospective, open label randomized study. The purpose of this study is to compare~     propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically~     identifying important patient demographics and looking at important outcomes including~     adverse events.~   "
184333|NCT01152008|"~     We aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement~     of cutaneous blood flow during exercise.~   "
184359|NCT01151670|"~     RATIONALE: Pioglitazone hydrochloride may be effective treatment for cognitive dysfunction~     caused by radiation therapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of pioglitazone~     hydrochloride in preventing radiation-induced cognitive dysfunction in treating patients with~     brain tumors.~   "
184334|NCT01151995|"~     This pilot project will evaluate Internet-based remote access to electronic clinical systems~     to support study monitoring tasks. The project engages two NIH-sponsored clinical trial~     networks (adult: ARDS network; pediatrics: ChiLDREN network) at five trial locations and two~     coordinating centers located across four states, which engages three collaborating~     NCRR-funded CTSA institutions. Each study location uses different electronic clinical systems~     and remote access methods, replicating the diversity of clinical applications and access~     methods found across large research networks. The results of this pilot project will inform a~     broader project that will engage all trial sites with electronic clinical systems in both~     national networks.~      This proposal extends Specific Aim 1.2 of the Research Informatics Integrated Core (RIIC) in~     the parent grant (UL1 RR025780) for the Colorado Clinical and Translational Sciences~     Institute (CCTSI): The RIIC will develop and implement tools and services that will….(2)~     support the efficient execution of the CCTSI translational research projects. (CCTSI grant~     page 1053). Specific Aim 1.2 proposes to develop new informatics methods that increase the~     translational research capacity by improving the efficiency of executing clinical studies.~     Reducing barriers to study monitoring via remote access will enable new innovative approaches~     to protecting study subjects, ensuring study data quality and documenting regulatory~     compliance. An example of a completely new model for study monitoring could be continuous~     study monitoring from any coordinating center to any study location in the Internet-connected~     world.~      We hypothesize that remote monitoring will demonstrate substantial improvements in study~     monitoring efficiency, effectiveness, and possibly overall costs when compared to present~     monitoring plans that require a prolonged on-site visit by a study monitor from the~     coordinating center. We do not claim that remote study monitoring will replace all monitoring~     tasks . But, for monitoring tasks that require access to electronic clinical data, we seek to~     demonstrate that remote access can enable more frequent SDV and regulatory documentation~     compliance, which in turn could facilitate new models of continuous study monitoring. The~     results of these studies would support improvements in study monitoring that would both~     significantly reduce the cost of conducting large multi-center clinical while improving the~     safety of those patients who are enrolled into these trials~   "
184335|NCT01151982|"~     The main objective is to measure the effectiveness of a new intervention for primary~     prevention of major depression based on the level and profile of risk of primary care~     attendees. Among the secondary objectives is to evaluate the cost-effectiveness and~     cost-utility of the intervention versus usual care. METHODS: This is a cluster, randomised~     controlled trial of a community intervention with cluster at the level of practice. It will~     be undertaken in primary medical care in 7 Spanish cities and 5 autonomous communities.The~     aim is to evaluate a new intervention for primary prevention of major depression based on~     patients' level and profile of risk. Family doctors in the intervention practices will~     provide the intervention for patients at risk. Patients at risk who are recruited in control~     practices will receive usual primary care. The main outcome is the accumulated incidence of~     major depression (measured by CIDI) during the follow-up. The investigators will assess main~     outcomes and other covariables at baseline, 6, 12, and 18 months. A random sample of 3,381~     primary care attendees (1,690 for each arm), aged 18-75 and without major depression will be~     recruited in 70 health centres (140 family doctors) in 7 cities. The investigators shall~     undertake a logistic regression multilevel model with 4 levels (time, patient, doctor and~     health centre). The investigators shall also undertake multivariate gamma and quantile~     regression to assess respectively the cost-effectiveness and cost-utility of the new~     intervention versus usual care, estimating their standard errors by bootstrap.~   "
184336|NCT01151969|"~     The main objective is to measure the effectiveness of a new intervention to decrease use of~     services of primary care frequent attenders (FA).Among the secondary objectives are to~     evaluate the cost-effectiveness and cost utility of the new intervention compared with usual~     care.~      METHODS: There will be a randomized controlled trial with cluster assignment. It will take~     place in the field of primary care in the city of Malaga.It will be evaluated a new~     multicomponent intervention called 7H (7 Hypothesis). This intervention will be applied on~     the FA by their family doctors in the intervention group. In the control group will be~     developed usual cares.~      The main outcome is the total of visits of FA at 12 months of the follow-up. The secondary~     outcomes include changes happened in biopsychosocial health, satisfaction, and quality of~     life measurements. The investigators will assess the dependent and independents (from FA,~     general practitioner [GP] and health centres) variables at baseline, and 12 months. At~     baseline it will be include a random sample of 450 FA (225 for each arm), belonging to 30~     family doctors of 10 health centres. It will be performed linear regression multilevel models~     with 4 levels (time, patient, doctor and health centre) to evaluate the effectiveness of the~     intervention. . Moreover will be undertaken multivariate gamma and quantile regressions to~     assess the cost-effectiveness and cost-utility respectively of the new intervention versus~     usual cares, estimating their standard errors by bootstrap calculations.~   "
184337|NCT01151956|"~     Objective: To show how dermatologists treat actinic keratoses with imiquimod 5% cream in~     their daily clinical routine.~      Design: Prospective, non-interventional, observational, multicenter clinical study.~      Setting: Offices of 93 non hospital based Austrian dermatologists. Participants: Inclusion of~     the 463 patients into the study was solely based on the treatment decision of the~     dermatologist and the patients will.~      Interventions: No specific interventions except suggested time points of visits with~     pre-defined documentation forms. The therapy of actinic keratoses followed the imiquimod~     label (3x/week for 4 weeks, 4 therapy free weeks, another 3x/week for 4 weeks, when needed)~     Main outcome measure: Information about the typical imiquimod patient, therapeutic course,~     treatment decisions, safety and satisfaction of patients/dermatologists.~   "
184338|NCT01151943|"~     Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia,~     will be randomized to undergo either TAP block or incisional infiltration with local~     anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen,~     nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in~     case of severe pain.~   "
184339|NCT01151930|"~     The primary objective is to characterize the safety profile of long-term exposure to SCB01A~     when administered to cancer subjects with advanced solid tumors. Furthermore, the efficacy~     profile will also be explored in this study.~   "
184340|NCT01151917|"~     Glycemic control is rapidly restored in patients with insulin resistance after bariatric~     surgery, in particular after the mal-absorptive one (i.e. Bilio-pancreatic diversion, BPD).~     To evaluate the mechanisms allowing restoration of insulin sensitivity after BPD the~     investigators aimed at identifying by using a proteomic approach plasma proteins or peptides~     that may be involved in the remarkably fast and explicit restoration of insulin sensitivity.~     In addition to the unbiased proteomics approach, a selection of recognized markers for~     metabolic control will be measured. These efforts all aim at an increased understanding of~     how insulin sensitivity is regulated and may provide novel ideas of how to treat insulin~     resistance and type 2-diabetes.~   "
184341|NCT01151904|"~     This study will evaluate the safety and efficacy of patients switched from latanoprost~     monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol~     0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.~   "
184346|NCT01151839|"~     Carcinoma of the esophagus is the among the most common cancers in Indian population. While~     adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the~     more frequent form. Surgery is the standard treatment in resectable lesions, but survival is~     poor. Adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results.~     Though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the~     methodology was inhomogeneous and the populations studied were different. The investigators~     will be conducting a randomized controlled trial in patients with squamous cell carcinoma of~     the esophagus. Preoperative chemoradiation followed by surgery will be compared with surgery~     alone.~   "
184347|NCT01151826|"~     Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung~     transplantations and leads to severe early and late postoperative complications. Its~     pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased~     vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas~     exchange and blood oxygenation.Its substrate, namely extravascular lung water (EVLW), can now~     be clinically measured with minimally invasive Intensive Care Unit monitors (PiCCO2®, Pulsion~     Medical Systems) that also provides a physical estimate of pulmonary vascular permeability~     (PVPI). Similarly, biochemical correlates of vascular permeability (ICAM-1) and pneumocyte~     dysfunction (RAGE) can now be measured in plasma samples. Our study aims at quantifying~     physical and biochemical markers of PGD and assess their diagnosis and prognosis values.~   "
184348|NCT01151813|"~     This is a Phase II within-subjects double-blind placebo-controlled human laboratory study.~     The purpose of the study is to determine the efficacy of varenicline (Chantix) for reducing~     cue-induced cocaine and alcohol craving.~   "
184349|NCT01151800|"~     The purpose of this study is to determine whether interactive voice response (IVR) technology~     can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best~     practice guidelines (BPGs).~      The study hypothesis is that ACS patients who are contacted by IVR technology will be more~     likely to receive care as recommended in the BPGs than those followed by usual care.~   "
184350|NCT01151787|"~     The primary objective of the study is to evaluate the effectiveness and safety of~     cyclobenzaprine hydrochloride extended release (Amrix 15mg/day) for the prophylaxis of~     chronic migraine compared to a placebo medication. A second objective, is to find out whether~     there is an improvement in quality of sleep and self-reported depression in patients taking~     Amrix 15mg daily. The hypothesis is that the number of migraine days per month of patients~     treated with Amrix 15mg daily will be significantly lower than those patients treated with~     placebo.~   "
184351|NCT01151774|"~     The study doctors are trying to determine if the TEE measurements from your stomach are~     helpful in measuring the blood flow to the kidneys.~   "
184352|NCT01151761|"~     The purpose of this study is to determine progression-free survival at 12 months for~     stereotactic body radiotherapy (SBRT) and chemotherapy for unresectable hilar~     cholangiocarcinoma (CCA).~   "
184353|NCT01151748|"~     Phase II study of selective intra-arterial infusion of chemotherapy for intraocular~     retinoblastoma~   "
184354|NCT01151735|"~     The study hypothesis is that treatment of Hereditary Angioedema at the time of prodromal~     symptoms will decrease morbidity associated with the disease~   "
184355|NCT01151722|"~     Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative~     diabetic retinopathy. There have been efforts to lower the incidence of postoperative~     vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a~     potent inhibitor of angiogenesis and has been shown to decrease retinal and iris~     neovascularization in proliferative diabetic retinopathy. Recently there have been reports~     showing that preoperative bevacizumab injection could reduce intraoperative bleeding from~     abnormal vessels and could make surgery easier and more successful. Our hypothesis is that~     intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by~     inhibiting the vessel formation after surgery.~      We started the prospective randomized comparative study to determine the effect of pre and~     intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic~     vitrectomy in comparison to vitrectomy without any adjuvant drug.~   "
184356|NCT01151709|"~     This is a questionnaire study aimed at learning about physicians' views on the treatment of~     Gout.~   "
184357|NCT01151696|"~     Unexpected acute pain in an emergency setting causes anxiety, insecurity, and stress that can~     diminish perceptions of control over pain and diminish ability to decrease pain. This may~     interfere with the opioid treatment and poses the question of whether an anxiolytic drug~     added to the morphine titration could relief pain and/or anxiety. This randomized~     double-blind group clinical trial is designed to determine the efficacy and safety of~     hydroxyzine in addition to a conventional intravenous morphine titration protocol.~   "
184358|NCT01151683|"~     Introduction: Magnesium has been the target for many experimental and clinical studies due to~     the negative correlation between its serum and intracellular levels and the prevalence of~     hypertension and other cardiovascular diseases.~      Objective: To evaluate the effects of magnesium supplementation in hypertensive patients who~     are under diuretic treatment, including correlation of clinical and nutritional parameters~     with structural and functional aspects of the macrocirculation.~      Methods: A prospective, randomized, double blind, placebo controlled study will be performed~     in hypertensive patients, aged between 40 and 65 years-old, in regular use of thiazidic~     diuretic as antihypertensive monotherapy,. The patients will be divided in two main groups~     according to supplementation with placebo or magnesium chelate 300mg twice a day (total of~     600mg magnesium element per day). Before and after 3 and 6 months of supplementation, the~     patients will be submitted to clinical and nutritional evaluation, biochemical analysis,~     including intracellular magnesium measurement, and study of the macrocirculation with~     ambulatory blood pressure monitoring, analysis of flow-mediated dilation of brachial artery,~     measurement of carotid intima-media thickness, and carotid-femoral and carotid-radial pulse~     wave velocity to estimate central and peripheral arterial stiffness.~      Analysis: Data will be expressed as mean±epm. Statistical analysis will be performed using~     software Prism® (GraphPad, version 5.0). Continuous variables in each group will be compared~     using t test, and P<0.05 will be considered statistically significant.~   "
184409|NCT01151072|"~     This trial was conducted in Europe. The aim of this clinical trial was to compare the~     exposure and effect of NN1250 (insulin degludec) after different routes of injection in~     healthy subjects.~   "
184360|NCT01151657|"~     The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to~     placebo, when given for 6 months.~      By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either~     probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients~     are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of~     monthly letters.~      The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei~     F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109~     CFU/capsule.~      The hypothesis is, that there is a clinical difference between the group receiving probiotics~     and the group receiving placebo.~   "
184361|NCT01151644|"~     The prognosis of rheumatic diseases has improved considerably with development of therapy.~     However, infections are considered the most important cause of morbidity and mortality in~     this group of patients. One of the ways to prevent such complications is vaccination. In~     2009, a new pandemic strain of influenza virus (A/H1N1/2009) has emerged raising major~     concerns for public health. Patients under immunosuppressive therapy have indication for~     immunization against influenza virus H1N1. There are, however, concerns about possibility of~     reactivation of autoimmune diseases, determine adverse events and insufficient immunogenicity~     in these patients. The lack of studies evaluating the efficacy and safety of the vaccine~     against influenza A(H1N1)/2009 in these rheumatic patients led to the development of this~     research. The objectives of this study are to evaluate the humoral response and safety of the~     vaccine virus A(H1N1)/2009 in immunosuppressed patients with rheumatic diseases compared to~     healthy controls. We have recruited 400 patients with rheumatoid arthritis, 350 with~     spondyloarthritis, 1000 with systemic lupus erythematosus (SLE), 150 with dermatomyositis~     (DM), 100 with mixed connective tissue disease, 150 with systemic vasculitis, 250 with~     systemic sclerosis (SSc) , 100 with Sjögren's syndrome, 100 with antiphospholipid syndrome,~     100 patients with juvenile idiopathic arthritis, 80 with juvenile SLE, and 80 with juvenile~     DM, followed at our Rheumatology Outpatient Division and Unit Pediatric Rheumatology~     Children's Institute, HC-FMUSP. The control group was recruited were 200 healthy employees of~     ICHC-FMUSP. Informed consent was obtained from all participants and the study was approved by~     the Local Ethical Committee. All subjects were vaccinated against influenza virus~     A/(H1N1)/2009 (vaccine approved and supplied by Instituto Butantan-São Paulo). Blood samples~     was collected to measure levels of antibodies inhibiting hemagglutination by influenza virus~     A (H1N1)/2009 immediately prior to vaccination and 21 to 28 days after vaccination.,~     Participants fulfilled a questionnaire on the immediate side effects of the vaccine. All~     patients with rheumatoid arthritis, spondyloarthritis, SLE, DM, systemic vasculitis, juvenile~     idiopathic arthritis, juvenile SLE, and DM were assessed before and 21 days after vaccination~     for clinical, laboratory parameters of disease activity as well as treatment. Continuous~     variables will be compared by t-test to evaluate differences between patients with rheumatic~     diseases versus healthy controls. Differences between categorical variables will be evaluated~     using the chi-square or Fisher exact test. Statistical significance was set at p<0.05.~   "
184362|NCT01151631|"~     Cluster headache (CH) is a primary headache disorder characterized by recurrent short-lasting~     attacks (15 to 180 minutes) of excruciating unilateral periorbital pain accompanied by~     ipsilateral cranial autonomic signs. The 1-year prevalence of CH is about 0.1 %, the male:~     female ratio is 3:1. The majority of patients have cluster periods of weeks to months with~     frequent attacks which are alternated with symptom-free periods of months to several years;~     the episodic from of CH. In about 10% of patients the CH is chronic (CCH) in which either no~     remission occurs within 1 year or the remissions last less than 1 month. At least 10 % of CCH~     patients are refractory to medical treatment or cannot tolerate the treatments.~      Recent pilot studies suggest that occipital nerve stimulation (ONS) in medically intractable~     CCH (MICCH) might offer an effective alternative to medical treatment. There are no~     randomised clinical trials and a placebo effect cannot be excluded. Long term tolerability is~     known from other indications.~      Here the investigators propose a prospective, randomised, double blind, parallel group~     multi-centre international clinical study to compare the reduction in attack frequency from~     baseline of occipital nerve stimulation (ONS) in patients with MICCH between two different~     stimulation conditions: high (100%) and low (30%) stimulation.~      Following implantation there will first be a run-in phase of 10 days of 10% stimulation~     intensity, followed by a stepwise monthly increase up to either 30% or 100%. Patients will be~     assessed monthly by a blinded assessor. The primary outcome measure is the mean number of~     attacks over the last 4 weeks of the double blind 6 month treatment period in the 100% versus~     the 30% treatment group. Hereafter, in an open extension phase of 6 months, all patients will~     receive 100% stimulation or the stimulation considered optimal by the patient.~      Secondary outcome measures include the rate of responders (≥ 50% reduction in attack~     frequency during the last 4 weeks of each treatment period), patient's satisfaction,~     medication use, quality of life, mean pain intensity, economic evaluation and whether~     patients would recommend the treatment to another patient. The investigators will also~     investigate whether predictive factors can be identified for efficacy.~   "
184363|NCT01151605|"~     This study will help us understand the possible beneficial effects of insulin in~     inflammation. Inflamamtion is considered to be the cause of atherosclerosis and heart~     disease.~   "
184364|NCT01151592|"~     The objective of this study is to assess the safety and tolerability of Venofer in patients~     with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron~     containing a dextran (INFed or Dexferrum).~   "
184365|NCT01151579|"~     The purpose of the study is to determine adverse events rates of nebulized albuterol versus~     levalbuterol among adult critically ill patients and determine if a differential exists in~     adverse events between the two drugs.~   "
184366|NCT01151566|"~     Computed tomography (CT) scan, performed with contrast enhancement, is one of the most~     commonly requested examinations in diagnostic imaging. In a patient with an elevated~     creatinine or an allergy to contrast agents, the scan may be performed without the benefit of~     contrast enhancement. Ultrasound (US), performed with contrast agent enhancement does not~     have any nephrotoxicity and may be performed on patients with CT contrast allergy. The~     investigators propose that US with Contrast enhanced ultrasound (CEUS) is superior to~     unenhanced CT scan in this population.~   "
184367|NCT01151553|"~     This is a research study that is evaluating blood markers which may predict which patients~     who receive CRT will improve. Congestive heart failure (CHF) is associated with increased~     oxidative stress, a condition where abnormal oxygen forms are produced. These forms harm the~     cells of the heart and cause damage to the heart muscle. We would like to see if blood levels~     of these forms improve after CRT, and if they can be measured early after surgery to predict~     who will and who will not benefit from surgery.~   "
184368|NCT01151540|"~     To investigate the safety of long term administration of E2080 in the patients with~     Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.~   "
184369|NCT01151527|"~     We hypothesize that a peripheral blood biomarker or biological signature (gene or protein~     expression pattern) of idiopathic interstitial pneumonias (IIPs) will simplify and improve~     the accuracy of diagnosis of IIP and diagnose individuals at an earlier, more treatable,~     stage of their disease.~   "
184370|NCT01151514|"~     Few studies analyzed the referral time to nephrologists and its impact on the patient outcome~     in a large cohort. The investigators described the incidence and determined the outcome with~     respect to renal function recovery, renal replacement therapy (RRT) requirement and~     in-hospital mortality of Hospital Acquired Acute Kidney Injury (HA-AKI) without nephrology~     referral (nrHA-AKI) and late referred HA-AKI patients to nephrologists (lrHA-AKI) compared~     with early referral patients (erHA-AKI). The patients included were admitted to the tertiary~     care academic center of Lausanne (Switzerland) between 2004 and 2008, in the medical and~     surgical services and in the intensive care unit (ICU).~   "
184410|NCT01151059|"~     The present study will evaluate the safety and immunogenicity in healthy people (non-elderly~     adult and elderly subjects) after one intramuscular (IM) dose of trivalent subunit~     inactivated flu vaccine.~   "
184371|NCT01151501|"~     Acute hypoxaemic respiratory failure (AHRF) refers to pathological states in which arterial~     blood oxygenation is severely impaired，and which need invasive positive pressure ventilation~     (IPPV) as respiratory support technique in most cases.However，IPPV carries well-known risks~     of complications such as ventilator induced lung injury (VILI) or ventilator associated~     pneumonia (VAP)，and the incidence of which is increased as the prolongation of IPPV so as to~     lead to higher mortality rate. Consequently，early extubation is extraordinarily necessary.~      More recently, NPPV has shown to shorten the duration of IPPV，reduce the mortality and~     morbidity rates in patients with chronic obstructive pulmonary disease (COPD). Despite this~     evidence, the efficacy of NPPV in patients with AHRF has not been evidenced. However，NPPV has~     been shown to provide adequate ventilation and oxygenation，and reduce inspiratory muscle~     effort，neuromuscular drive，and dyspnea scores. Moreover，to some patints，NPPV is similar with~     IPPV in providing oxygenation.~      The duration of weaning is from the first day a patient met standard criteria for weaning~     readiness to the time of successful extubation (lasting at least 48 h)，which represents~     40-50% of the total duration of IPPV.As a result，duration of IPPV would be shortened if that~     of weaning was shortened.~      The investigators hypothesized that in mechanical ventilated patients with AHRF who met~     standard criteria for weaning readiness and suffer failure of spontaneous breathing trial,~     use of NPPV for early extubation, providing adequate ventilation and oxygenation, would~     shorten the duration of IPPV as the primary end-point variable, thereby reduce the incidence~     of complication and mortality rates. Accordingly, the investigators conducted a~     prospective，randomized clinical trial to assess the efficacy of this strategy compared with~     the conventional-weaning approach.~   "
184372|NCT01151488|"~     The purpose of the study is to examine the effects of resistance training on the reasons~     (mechanisms) underlying the development of fatigue, muscle weakness and wasting (sarcopenia),~     and impaired physical functioning (poor balance and walking) associated with breast cancer~     survivorship.~   "
184373|NCT01151475|"~     We wish to study patients with liver cirrhosis during and 2 weeks after an acute episode of~     liver coma (hepatic encephalopathy). By means of Positron Emission Tomography we investigate;~     brain blood flow, brain ammonia uptake and brain oxygen consumption. We hypothesize that~     blood flow an oxygen consumption is diminished and ammonia uptake increased during an acute~     episode of hepatic encephalopathy.~   "
184374|NCT01151462|"~     The aim of this study is to investigate short and long term consequences from early postnatal~     HCMV infection transmitted via human milk in very preterm infants (birth weight < 1500 g or~     gestational age < 32 weeks). These infants are at high risk of early death or survival with~     chronic disease and neurodevelopmental impairment if infected with HCMV. Infection is a~     common complication in this group of patients and reported to be the most frequent cause of~     death after the second week of life. Systemic infection in the newborn period is reported as~     representing an independent risk factor for survival with neurodevelopmental impairment among~     very preterm infants.~   "
184375|NCT01151449|"~     This phase II clinical trial studies how well gamma-secretase/Notch signalling pathway~     inhibitor RO4929097 works in treating patients with advanced, metastatic, or recurrent triple~     negative invasive breast cancer. Gamma-secretase/Notch signalling pathway inhibitor RO4929097~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
184376|NCT01151436|"~     The aim of this study is to assess performance and tolerance as well as investigator and~     subject satisfaction linked to the global management of facial rejuvenation with a new range~     of hyaluronic acid dermal fillers.~   "
184377|NCT01151423|"~     The purpose of this study is to determine whether anti-von Willebrand factor Nanobody is safe~     and effective as adjunctive treatment in patients with acquired thrombotic thrombocytopenic~     purpura (TTP). Patients will receive either placebo or anti-von Willebrand factor Nanobody as~     adjunctive therapy to plasma exchange.~   "
184378|NCT01151410|"~     The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term~     safety, tolerability and efficacy profile of aliskiren compared to the active comparator~     enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age,~     gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive~     either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be~     administered once daily and children will receive study medication in a double-blind manner.~     This study is being conducted to support monotherapy registration of aliskiren for the~     treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study~     CSPP100A2365).~   "
184379|NCT01151397|"~     Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy~     obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3.~     Studies rarely address the issues of improving host factors. The current study examines~        1. Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and~          shorten treatment duration (from 24 weeks to 12 weeks)~        2. whether Vitamin D levels predicts negative treatment outcome.~   "
184380|NCT01151384|"~     Liposome Encapsulated Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel~     developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum~     tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. It was~     also evaluated for pharmacokinetic and anti-tumor effects.~   "
184381|NCT01151371|"~     The objective of the study is to compare the clinical performance of silicone hydrogel daily~     disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone~     hydrogel monthly replacement contact lenses.~   "
184382|NCT01151358|"~     MERIT-NHL as an addendum to the International Registry of Radioimmunotherapy (RIT registry)~     pooling clinical data of patients who suffered from a non-Hodgkin´s lymphoma also includes~     the documentation of the respective FDG-PET and CT-image files in an online archive.~      Based on these documented clinical and imaging data, the MERIT study group centrally performs~     an intra- as well as interindividual evaluation of follicular CD20+ lymphoma lesions before~     and after radioimmunotherapy. According to this, the aim of the MERIT-NHL study is to~     prospectively identify yet unknown patient- and lesion specific prognostic factors predicting~     patient´s outcome in line with the therapeutic modality radioimmunotherapy.~   "
184383|NCT01151345|"~     This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg~     Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by~     Amstrong Laboratorios De Mexico, S.A. DE C.V.~   "
184384|NCT01151319|"~     This is a randomised, placebo-controlled, single-blind study designed to evaluate the safety~     and immunogenicity of three novel HIV vaccines.~   "
184411|NCT01151046|"~     To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer~     patients is more effective than Exemestane alone~   "
184412|NCT01151033|"~     The objective of this study is the assessment of the performance, safety and efficacy of the~     ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo~     native coronary artery lesions.~   "
184385|NCT01151306|"~     Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in~     breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current~     treatments have focused on opening up the narrowed airways but, in addition, we know there is~     increased inflammation in the blood and these patients are at increased risk of heart~     disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the~     blood but may also reduce inflammation and lower the risk of heart disease. This study will~     explore whether simvastatin reduces one of the risk factors in patients with COPD in a short~     term proof of principle study. The key purpose is to determine whether simvastatin improves~     the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of~     aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or~     blood inflammation and change in breathing ability~   "
184386|NCT01151293|"~     Diabetes is one of the most common causes of death in Taiwan. With the raising prevalence of~     diabetes, it became the fourth most common cause of death since 2002. Up to one-tenth of the~     national health insurance expenditure was used directly in diabetic care. Besides, more~     expenditure was used in the management of the complications of diabetes, like vascular~     diseases, renal disease, blindness and neuropathy. Diabetes is a chronic disease, the target~     treatment is to control HbA1c below 7%, by intensive life style modification, diet control,~     exercise and medications. Diabetic patient should have a good medical compliance, in order to~     prevent the tragedy of the complication. A good medical compliance is depended on the~     individual personality. Personality is the major cause of chronic stress, which is one of the~     most important cause of psychological stress and the risk factors of the vascular disease and~     hypertension. Recently, Type D personality had shown the close relationship with patients'~     prognosis, morbidity, mortality and life quality in different vascular diseases. These~     vascular diseases are the result of the atherosclerotic process, and diabetes is one of the~     most important risk factors of the atherosclerotic changes. The investigators believed that~     type D personality may also affect the medical compliance, the severity (in terms of HbA1c),~     and the prognosis of diabetic patients. The first part of this study is a cross sectional~     study, the investigators will try to figure out the relationship of the type D personality~     toward diabetic medical compliance, and their comorbidity. The second part of this study is a~     cohort study, base on the population in first part of the study, the investigators will like~     to construct the correlation of type D personality and diabetic patients' 5-years~     complication and mortality. The investigators want to establish a more complete vascular care~     system, improve the medical compliance, lower the complication rates, and improved the~     quality of life.~   "
184387|NCT01151280|"~     The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary~     RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant~     (OLT) patients.~   "
184388|NCT01151267|"~     The rate of elimination of inhalation agent is directly proportional to the degree of~     alveolar ventilation. Using Isocapnic Hyperpnoea (IH) device, it is possible to maintain~     constant end-tidal CO2 with increased minute ventilation. This is achieved by passively~     adding a flow of CO2 to the inspirate in proportion to increases in ventilation above the~     baseline. In animal and human studies IH shortens the time of awakening from isoflurane and~     sevoflurane anesthesia when manual positive pressure ventilation is applied. IH device could~     be used for spontaneous hyperpnoea as well. The investigators want to compare recovery times~     from sevoflurane anesthesia in patients with application of hypercapnic spontaneous~     hyperpnoea (HSH) versus the standard anesthesia protocol (controls). 44 patients ill be~     randomized to either HSH facilitated recovery, or conventional recovery (controls).The time~     intervals from the end of anesthesia (turning off the vaporizer) until recovery milestones~     will be recorded.~   "
184389|NCT01151254|"~     All patients undergoing cardiac surgery require intraoperative anesthesia and short-term~     postoperative sedation with anesthetic agents after the procedure when patient is in the~     intensive care unit (ICU). The clinical data obtained so far are concentrating on~     intraoperative use volatile agents (preconditioning) resulting in better postoperative~     cardiac function and less release of biochemical markers of myocardial damage. There are no~     studies investigating whether postoperative use of volatile agents (post conditioning) in~     cardiac surgical population is improving outcomes. The aim of the present study is to compare~     total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and~     postoperative sedation in cardiac surgical population.~   "
184390|NCT01151241|"~     Patients undergoing elbow arthroscopy surgery will receive standard anesthesia and analgesia~     (infraclavicular nerve block combined with general anesthesia for surgery; continuous~     infusion via infraclavicular catheter to day 3 post op). Patients in the experimental group~     will be discharged home after one day, with infraclavicular catheter in place; patients in~     the comparator group will stay in hospital for 3 or 4 days, per standard practice. The study~     will compare range of motion as the primary endpoint, in a non-inferiority design, to see if~     early discharge is feasible while providing similar recovery.~   "
184391|NCT01151228|"~     Patients undergoing gastroscopy will undergo two pre-procedure ultrasound scans of the~     stomach, once on arrival in the unit and on an empty stomach and a second time after~     consumption of a randomized amount of apple juice (0, 50, 100, 200, 300 or 400 mL).~     Immediately after ingestion and the second ultrasound scan, subjects will have their~     gastroscopy which will start by suctioning out the apple juice. Measurements of stomach fluid~     volume conducted by ultrasound will be compared to the actual volume removed during the~     gastroscopy procedure.~   "
184392|NCT01151215|"~     The main purpose of this study is to compare progression free survival in patients treated~     with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary~     objective is to investigate the safety and tolerability of AZD8931 given in combination with~     anastrozole.~   "
184393|NCT01151202|"~     The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to~     evaluate the safety and efficacy in patients with acute upper respiratory tract infection and~     chronic inflammatory bronchitis.~   "
184394|NCT01151189|"~     This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to~     evaluate the protective efficacy against TB disease, safety, and immunogenicity of~     MVA85A/AERAS-485 in healthy, HIV-infected adults.~      This study consists of 650 adults subjects (ages 18-50 years of age inclusive) who will~     receive study vaccine or placebo at Study Day 0 and again 6-9 months later. Samples for~     real-time evaluation of immunogenicity were to be collected from 70 subjects (immunogenicity~     analysis set).~   "
184395|NCT01151176|"~     The study aims to demonstrate that a simple intravenous insulin algorithm can be implemented~     in Latin America and will result in safe and better glucose control in patients with Acute~     Coronary Syndrome (ACS) compared with SC insulin.~   "
184413|NCT01151020|"~     The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US~     FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular~     Graft indicated for the treatment of patients with aneurysms/ulcers of the descending~     thoracic aorta having vessel structure suitable for repair.~   "
184396|NCT01150916|"~     The serum albumin ascites gradient (SAAG) is a recommended tool for ascites diagnosis since~     values ≥1.1 g/dl are found in nearly 97% of patients with portal hypertension. However, it~     mislabels chronic liver disease and heart failure as the cause of ascites. Because type-B~     Natriuretic Peptide (BNP) is increased in several body fluids of patients with both systolic~     and diastolic dysfunction, it was found to be a useful marker for diagnosing heart failure~     and pleural effusion due to heart failure. Nevertheless, to date, the performance of BNP~     testing for assessing the etiology of ascites has not been examined. The current prospective~     study is aimed at comparing the following strategies for diagnosing heart failure as the~     cause of ascites: 1) SAAG plus total protein concentration in ascitic fluid (gold standard);~     2) SAAG plus BNP concentration in ascitic fluid; 3) SAAG plus BNP concentration in serum; 4)~     serum BNP concentrations.~      SAAG, ascitic fluid protein concentration, serum and ascites type-B Natriuretic Peptide and~     echocardiography will be performed in all patients. The final diagnosis of the cause of~     ascites will be adjudicated by independent physicians, blinded for the results of ascitic~     fluid biochemistry and BNP. Patients will be divided into four groups: Heart failure, Liver~     cirrhosis, concurrent heart failure and liver cirrhosis (mixed) and other causes of ascites.~   "
184397|NCT01150851|"~     The central aim of this study is to improve understanding of how metabolic pathways that~     contribute to adiposity also amplify risks of kidney disease progression and cardiovascular~     disease in subjects with moderate to severe CKD. In order to achieve this goal, we propose~     the following aims through a randomized 2x2 factorial design trial in subjects with moderate~     to severe CKD: (a) To assess the feasibility of implementing aerobic exercise and caloric~     restriction interventions, and (b) To examine the effects of aerobic exercise and caloric~     restriction on a metabolic risk profile, including systemic measures of oxidative stress,~     inflammation, insulin resistance, and endothelial dysfunction.~      Hypothesis: We hypothesize that implementation of caloric restriction and aerobic exercise is~     feasible and can improve the metabolic milieu (as assessed by measures of oxidative stress,~     inflammation, insulin resistance, and endothelial dysfunction) in subjects with moderate to~     severe CKD.~      Interim analysis may be performed (no specific plan at this time).~   "
184398|NCT01150838|"~     The purpose of this study is to determine the least amount of propofol that is needed to~     place a breathing tube in children 1-12 years old.~   "
184399|NCT01150747|"~     The primary objective is to prospectively follow 200 women with or at risk of cervicitis to~     determine the chlamydia-specific cellular responses that correlate with protection against~     incident infection. The hypothesis is that a positive IFN-y response by peripheral CD4+ T~     cells responding to stimulation with HSP60 will be significantly associated with protection~     from incident C. trachomatis infection.~   "
184400|NCT01149239|"~     This study is to evaluate the level of anxiety, and to check the correlation of induction~     dose and the amount of sevoflurane to keep anesthetic depth in in female patients undergoing~     thyroidectomy.~   "
184401|NCT01149226|"~     Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia~     in Day-case Pediatric Surgery~   "
184402|NCT01151163|"~     Fibromyalgia syndrome (FMS) is characterized by the presence of widespread pain, chronic~     fatigue and typical sleep disturbances. The purpose of the current study is to investigate~     the nature of sleep disturbance in FMS, using a novel technology. Peripheral arterial~     tonometry is a method by which peripheral arterial tone is measured non - invasively using in~     an ambulatory setup during sleep. The information collected reflects autonomic nervous system~     function and respiratory changes during sleep. We intend to utilize this technique in order~     to improve our understanding of the interrupted patterns of sleep in FMS and as a possible~     biomarker which may be used in the future to follow up FMS patients and their response to~     treatment.~   "
184403|NCT01151150|"~     The current study is set up to chart clinically and laboratory findings in Norwegian patients~     with symptoms attributed by themselves or their doctor to ongoing chronic Bb infection.~     Objectives is to assess laboratory findings in relation to established diagnostic criteria~     and to form a picture of the burden of symptoms and illness perception in this group of~     patients. The study is essentially exploratory, and is supposed to raise rather than to test~     hypotheses.~   "
184404|NCT01151137|"~     Primary Objective:~        -  Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events~          (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or~          unplanned cardiovascular hospitalization or death from any cause in patients with~          permanent Atrial Fibrillation [AF] and additional risk factors~      Secondary Objective:~        -  Demonstrate the efficacy of Dronedarone in preventing cardiovascular death~      This was an event-driven study where a common study end date [CSED] was to be determined by~     Steering Committee based on the number of events (stroke, systemic arterial embolism,~     myocardial infarction or cardiovascular death).~   "
184405|NCT01151124|"~     The study is designed to test the safety of a manufactured neural stem cell line (CTX cells)~     delivered by injection into the damaged brains of male patients 60 years of age or over who~     remain moderately to severely disabled 6 months to 5 years following an ischemic stroke. In~     addition the trial will evaluate a range of potential efficacy measures for future trials.~     Treatment will involve a single injection of one of four doses of CTX cells into the~     patient's brain in a carefully controlled neurosurgical operation performed under general~     anesthetic. The trial is designed to treat 12 patients and measure outcomes over 24 months.~     Patients will be invited to participate in a long-term follow-up trial for a further 8 years.~   "
184406|NCT01151111|"~     Parkinson's disease patients may have pronounced ON-OFF motor fluctuations. These motor~     fluctuations are currently treated with medication and surgery, which are limited by their~     efficacy and side effects. Our study aims to determine whether relaxation guided imagery can~     alleviate the OFF state of PD patients and therefore can be used as an adjunct to~     conventional medication.~   "
184407|NCT01151098|"~     The objective of this study was to evaluate the long-term safety and tolerability of 7-day~     BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain~     syndromes whose pain had been previously controlled by oral opioid combination therapy.~   "
184408|NCT01151085|"~     To collect the efficacy and safety informations of voriconazole related to their appropriate~     use in daily practice.~   "
184414|NCT01151007|"~     -  There is no data at present concerning the KRAS mutation in patients from Martinique~          with colorectal cancer. Despite the fact that the incidence of this disease continues to~          increase there is no recent data to confirm it. This study has a descriptive purpose,~          allowing a comparison of the population from Martinique to other populations.~        -  A study of incidence of colorectal cancer, overseen by the Association from Martinique~          for the Epidemiological Search on Cancer (AMREC), also leads to a better knowledge of~          the local characteristics of the colorectal cancer.~        -  These two descriptive characteristics of colorectal cancer in Martinique will be useful~          data for the health professionals to provide their patients better care.~   "
184415|NCT01150994|"~     The NIMH s RFA-Suicide Prevention in Emergency Medicine Departments recognizes the emergency~     department (ED) as an important setting to increase suicide detection and prevention efforts~     but observes that evidence-based practice guidelines do not exist. In response, we have~     designed the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) trial.~     The ED-SAFE study will be conducted using a quasi-experimental design appropriate for~     studying systems-based change. The study consists of two components (Screening Outcome &~     Intervention Evaluation) and three phases of data collection: Treatment as Usual, Screening~     Alone, and Intervention. During each phase, 480 suicidal patients (1,440 total) will be~     enrolled and followed using multiple methods for 12 months.~      The Screening Outcome Component~      The Screening Outcome component will use data collected during the Treatment as Usual and~     Screening Alone phases. Consistent with systems-change principles, when universal screening~     is incorporated during the Screening Alone phase, it will be completed by the primary nurse~     as part of routine care. Primarily, it will focus on testing a practical approach to screen~     ED patients for suicidal ideation and behavior and will assess its impact on suicide~     detection, process outcomes, and suicide behaviors.~      Intervention Evaluation Component~      The Intervention Evaluation component will use data from the Treatment as Usual, Screening~     Alone, and Intervention Phases. During the Intervention phase, each ED will implement a~     multi-component, systems-based Intervention called the Safety Assessment and Follow-up~     Telephone Intervention (SAFTI). The SAFTI will combine elements of: (a) safety planning~     administered by nursing staff in the ED, and (b) Coping Long Term with Active Suicide Program~     (CLASP)-ED, a series of up to 7 semi-structured telephone advising calls to the patient and 4~     to the significant other over the 12 months after the ED visit. Safety planning will be~     implemented universally to all suicidal patients, regardless of whether they are ultimately~     enrolled into the trial, as part of a comprehensive suicide management protocol (e.g., it is~     a systems-based change). However, for practical and budgetary considerations, the CLASP-ED~     telephone advising calls will be administered only to participants enrolled into the study.~      Our overarching hypotheses will be tested using a combination of the Screening Outcome~     component and the Intervention Evaluation Component. We predict that screening will improve~     detection of suicidal ideation, and the intervention will enhance the quality of care and~     reduce suicide outcomes.~   "
184416|NCT01150981|"~     Insulin resistance is a common condition that can lead to type 2 diabetes. One of the~     commonly prescribed diabetes medications, called rosiglitazone, works by decreasing insulin~     resistance. Rosiglitazone appears to work on fat cells. Animal studies suggest that~     rosiglitazone may work by increasing blood vessel growth in fat cells. The purpose of this~     research is to see if rosiglitazone also increases blood vessel growth in human fat cells.~     The investigators will compare results from before and after being on rosiglitazone for 6~     weeks.~   "
184417|NCT01150968|"~     The purpose of this study is to investigate whether the addition of teaching on communication~     at the end of life to the pre-existing resident curriculum will positively impact residents'~     knowledge and attitudes regarding communication at the end of life.~   "
184418|NCT01150955|"~     We want to investigate whether the food supplement resveratrol is able to counteract the~     detrimental effects of obesity.~   "
184419|NCT01150942|"~     To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in~     Korean healthy children aged 12~23 months~   "
184420|NCT01150929|"~     The purpose of this study is to determine whether patient rehabilitation is equal for~     patients operated with two different knee implant designs.~      The patients are randomized to treatment with either a simple hinge design implant (fixed~     bearing) or an implant with a mobile bearing polyethylene. This design difference might in~     principle enable the patients in the latter group to rehabilitate towards a more normal gait~     pattern.~   "
184421|NCT01150903|"~     Erectile dysfunction (ED) has been identified as an independent risk factor for existing~     cardiovascular disease, preceding a major cardiovascular event by an average of about 5~     years. Are men prescribed a PDE5 inhibitor for ED more likely to have a new diagnosis of~     underlying medical conditions compared to men of a similar age not receiving PDE5 inhibitor~     treatment?~   "
184422|NCT01150890|"~     The study will examine the safety and effectiveness of AMG 827 for the treatment of moderate~     to severe Crohn's disease. Patients will randomly receive either AMG 827 or placebo (a~     lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient~     will know what treatment is being given.~   "
184423|NCT01150877|"~     The purpose of this study is to investigate the therapeutic effect and the safety of~     high-dose vitamin D supplementation in metastatic colorectal cancer patients. We propose to~     supplement metastatic (stage 4) colorectal cancer patients with oral doses of vitamin D to~     raise serum 25-hydroxy-vitamin D [25(OH)D] levels to the high normal range of 200-250 nmol/L.~     The primary objective of this study is to evaluate the metabolic consequences, including~     tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with~     colorectal cancer. The secondary objective is to evaluate patient survival with regards to~     high-dose vitamin D supplementation.~      Hypothesis:~      Whereas low doses of vitamin D reportedly play a significant role in prevention of colorectal~     cancers, do much larger (pharmacological) doses of vitamin D have a significant therapeutic~     effect against the same kind of cancer?~   "
184424|NCT01150864|"~     The main hypothesis are:~        1. Passive and Active-Passive airway conditioning devices reduce the incidence of~          ventilator associated pneumonia~        2. Active-Passive airway conditioning devices reduce the incidence of endotracheal tube~          obstruction~        3. Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices~   "
184425|NCT01150825|"~     The primary objective of this study is to characterize the morphological patterns of high~     frequency QRS components (HFQRS) in patients with acute myocardial infarction (AMI),~     including STEMI and NSTEMI, compared to patients without AMI.~   "
184426|NCT01150812|"~     The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the~     pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after~     escalating single oral low doses.~   "
184427|NCT01150786|"~     The aim of this study is to determine the effect of selenium supplementation as an~     antioxidant on serum adiponectin, HSCRP , ferritin , transferrin, albumin and homocysteine~     level.~   "
184451|NCT01150448|"~     The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg~     equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to~     document the pharmacokinetics of paliperidone following fixed multiple intramuscular~     injections of paliperidone palmitate 150 mg eq.~   "
184428|NCT01150760|"~     Alvimopan is the first and currently the only FDA-approved therapy for acceleration of the~     time to upper and lower gastrointestinal (GI) recovery following partial large or small bowel~     resection surgery with primary anastomosis.~      The primary objective of this retrospective observational trial is to assess postoperative~     morbidity and mortality as reported during the index hospitalization for bowel resection and~     15/30-day readmissions of alvimopan vs. non-alvimopan matched patients in the combined~     Premier/Care Science database(a large medical claims database).~   "
184429|NCT01150734|"~     Muscle evoked potentials (MEP) are supposed to different in schizophrenic and depressed~     patients, compared to a sample of healthy volunteers. Transcranial Magnetic Stimulation~     (TMS)-evoked MEP are measured in all three groups at baseline and after tDCS (2 mA, 20~     minutes). MEP amplitudes are supposed to normalize quickly in healthy volunteers, to stay~     diminished in depressed patients and to stay elevated in schizophrenic patients. These~     differences should disappear after regular pharmacological treatment. Outcome measures will~     be done in week 2 and week 4.~   "
184430|NCT01150721|"~     Background:~      - Pulmonary nontuberculous mycobacterial infection is a respiratory infection that is~     sometimes difficult to diagnose. Proper diagnosis depends on accurate collection of~     respiratory secretions, but these secretions may be contaminated by bacteria present in the~     mouth at the time of collection. In addition, some individuals may have difficulty providing~     respiratory secretions, because the infection affects lung function and sputum production. By~     collecting new samples from individuals who have already been diagnosed with this infection,~     and comparing the methods of collection, researchers hope to better understand and improve~     the ability to accurately diagnose and treat the infection at an early stage.~      Objectives:~      - To compare throat cultures and coughed-up and induced phlegm or sputum in individuals with~     pulmonary nontuberculous mycobacterial infection and inflammation.~      Eligibility:~      - Individuals between 18 and 79 years of age who have been diagnosed with pulmonary~     nontuberculous mycobacterial infection and are currently participating in selected NIH~     protocols on this infection.~      Design:~        -  The study will require a single 90-minute visit to provide research specimens.~        -  Participants must not eat or drink for 2 hours prior to the collection of the early~          morning respiratory specimens. Blood pressure, temperature, pulse, breathing rate, and~          oxygen saturation level readings will be taken on the day of collection to ensure that~          participants may safely provide the specimens.~        -  Participants will provide the following samples:~        -  Blood sample: Participants will provide a blood sample to measure indicators of~          inflammation in the blood.~        -  Throat swab: Participants will brush their teeth thoroughly before allowing researchers~          to swab the inside of their throat with a sterile swab.~        -  Sputum collection (regular and induced): Participants will brush their teeth thoroughly~          and then provide both a regular sputum sample (produced normally) and an induced sputum~          sample (produced after using a nebulizer to stimulate sputum production).~        -  No treatment will be provided as part of this protocol.~   "
184431|NCT01150708|"~     Background:~        -  Syringomyelia is a disorder in which a cyst (syrinx) forms within the spinal cord and~          causes spinal cord injury, with symptoms worsening over many years, including paralysis,~          loss of sensation, and chronic pain. Researchers are interested in obtaining more~          knowledge about how a syrinx forms in order to develop safer and more effective~          treatments for syringomyelia and related conditions.~        -  The goal of surgical treatment of syringomyelia is to eliminate the syrinx and prevent~          further spinal cord injury. In most patients, surgery results in the syrinx becoming~          smaller, but the effect of surgery on a patient s muscle strength, pain level, and~          overall function has not been studied over time. In addition, some individuals with~          syringomyelia or related conditions are not considered to be good candidates for~          surgery, and more information is needed about potential alternative treatments for these~          individuals.~        -  By recording more than 5 years of symptoms, muscle strength, general level of~          functioning, and magnetic resonance imaging (MRI) scan findings from individuals who~          receive standard treatment for syringomyelia, researchers can obtain more information~          about factors that influence its development, progression, and relief of symptoms.~      Objectives:~      - To conduct a 5-year natural history study of individuals with syringomyelia and related~     conditions.~      Eligibility:~      - Individuals at least 18 years of age who have syringomyelia or related conditions~     (including pre-syringomyelia or Chiari I malformation without syringomyelia).~      Design:~        -  This study requires 7 outpatient visits to the National Institutes of Health Clinical~          Center: an initial visit; a visit 3 months later; and visits 1, 2, 3, 4, and 5 years~          after the initial visit. An additional 10 days of inpatient treatment and testing will~          be required if surgery is needed during the study.~        -  The following tests will be performed during this study:~        -  Medical history and physical examination, which may also determine eligibility for~          surgery~        -  Detailed neurological history and examination~        -  Blood and urine samples~        -  MRI scans: Participants will have 2 scans at the initial evaluation, 2 scans at the~          3-month visit, and 1 scan every year for the following 5 years.~        -  Additional neurological and imaging tests if needed, including a lumbar puncture to~          collect spinal fluid, a myelogram (imaging study) of the spinal fluid, and a computed~          tomography scan of the skull and spine.~        -  Participants who are surgical candidates will have additional tests along with the~          surgery, including diagnostic studies (electrocardiogram and chest X-ray) before surgery~          and an MRI scan 1 week after surgery.~   "
184432|NCT01150695|"~     The purpose of this study is to compare 2 experimental vaccines that could provide protection~     from the disease, tularemia. This research will compare the ability of the vaccines to cause~     the body to develop an immune (protective) response and obtain more information on side~     effects of the vaccines. About 220 male and non-pregnant female volunteers 18 to 45 years~     will participate. Volunteers will be assigned to 1 of 2 vaccine groups by chance. About half~     of the volunteers will be placed in the DVC-LVS vaccine group and half of volunteers will be~     placed in the USAMRIID-LVS vaccine group. Additionally, both groups will receive an injection~     of placebo (inactive salt water). Study procedures include physical exam and blood and urine~     samples. Evaluation of the vaccination sites will be performed as well as blood samples to~     measure the body's response to the vaccine. Participants will be involved in the study for~     about 6 months.~   "
184433|NCT01150682|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying the role of biomarkers in endometrial cancer~     recurrence in samples from patients with stage II, stage III, or stage IV endometrial cancer.~   "
184434|NCT01150669|"~     This research study is studying lestaurtinib with or with chemotherapy in samples from young~     patients with leukemia. Studying the effects of lestaurtinib with or without chemotherapy in~     cell samples from patients with cancer in the laboratory may help doctors learn more about~     the effects of this treatment on cancer cells. It may also help doctors identify biomarkers~     related to cancer.~   "
184435|NCT01150656|"~     RATIONALE: Studying the effects of obatoclax mesylate in cell samples from patients with~     cancer in the laboratory may help doctors learn more about the effects of obatoclax mesylate~     on cancer cells. It may also help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is studying obatoclax mesylate in samples from young patients~     with acute myeloid leukemia.~   "
184436|NCT01150643|"~     RATIONALE: Studying the effects of rituximab in blood and tumor tissue samples from patients~     with cancer in the laboratory may help doctors learn more about the effects of rituximab on~     cancer cells. It may also help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in samples from patients with follicular~     lymphoma treated with rituximab.~   "
184470|NCT01150188|"~     Elevated fat level in blood is a risk factor for coronary heart disease, a major cause of~     death in America. The overall goal of this project is to test a novel treatment using~     nutrient (amino acid) supplementation against this condition in men and women, and to~     understand how this treatment works.~   "
184471|NCT01150175|"~     The purpose of this study is to determine whether direct endomyocardial injection of~     autologous bone marrow cells is effective for enhancement of neovascularisation in patients~     with ischaemic heart failure.~   "
184437|NCT01150630|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin,~     epirubicin hydrochloride, and capecitabine, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving~     gemcitabine hydrochloride, with or without cisplatin, epirubicin hydrochloride, and~     capecitabine before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed. Giving these drugs after surgery may kill any tumor cells that~     remain after surgery.~      PURPOSE: This randomized phase II/III trial is studying how well gemcitabine hydrochloride,~     with or without cisplatin, epirubicin hydrochloride, and capecitabine, works when given~     before and/or after surgery in treating patients with stage I or stage II pancreatic cancer~     that can be removed by surgery.~   "
184438|NCT01150617|"~     Primary objective of the study is to test whether an intensified insulin therapy~     incorporating the target of normal fasting glucose (<5.5 mmol/L) and glycated hemoglobin~     <6.5% is able to halve the incidence of angiographic restenosis at 6 months (expected rate~     45%, to be reduced at 15%) after peripheral angioplasty compared with standard care to~     achieve a glycated hemoglobin <7.0% in patients with type 2 diabetes and limb ischemia.~      Secondary objectives include the identification of markers associated with, and predictive~     of, restenosis and the investigation of the underlying pathophysiological background, with~     specific focus on the role of nitric oxide (NO), mechanisms of endothelial~     activation/apoptosis, inflammation and matrix remodeling risk profiles, candidate gene~     polymorphisms and endothelial progenitor cells evaluation.~      Methodology: This is a randomized, open-label, clinical trial comparing two regimens of~     insulin therapy having as an outcome measure the incidence of angiographic restenosis at 6~     months after peripheral angioplasty. Seventy consecutive patients with type 2 diabetes and~     peripheral arterial disease undergoing peripheral angiography and subsequent angioplastic~     procedure will be studied. Patients will be treated by intensive insulin therapy, based on~     three pre-prandial administrations of regular insulin or short acting insulin analogues~     combined with the long-acting insulin analogue glargine or standard care based on once-daily~     insulin and oral antidiabetics agents. Patients randomized to the intensive insulin therapy~     arm will be educated and followed up with daily measurements of fasting glucose and weekly~     phone contacts with the target of fasting glucose <5.5 mmol/L (99 mg/dl) to obtain glycated~     hemoglobin <6.5%. The control arm will be followed to achieve a target of glycated hemoglobin~     <7.0%. Life style recommendations, including diet and physical activity program, will be the~     same for the two arms. All patients will undergo three visits with physical examination and~     blood sampling, at baseline and at 2, 4 and 6 months after angioplasty. Moreover, patients on~     normal fasting glucose arm will be monitored by phone on weekly basis in order to test their~     adherence to therapeutic target.~   "
184439|NCT01150604|"~     The purpose of this study is to determine whether an eight-lesson self-help intervention~     delivered online will result in a reduction of depressive symptoms.~   "
184440|NCT01150591|"~     Hypothesis 1: Microaspiration, as diagnosed by bronchoalveolar lavage (BAL) pepsin, is common~     in patients with IPF.~      Hypothesis 2a: Baseline clinical variables and co-morbid conditions are risk factors for~     microaspiration in patients with IPF.~      Hypothesis 2b: Baseline biological variables reflecting alveolar epithelial injury and~     inflammation are markers of microaspiration in IPF.~      Hypothesis 3a: Microaspiration will lead to a more rapid rate of decline in pulmonary~     function.~      Hypothesis 3b: Microaspiration will lead to higher rates of urgent medical care use (i.e.~     unscheduled clinic visit, emergency room visit, or hospitalization).~   "
184441|NCT01150578|"~     This study is for people who have a SPECT scan (nuclear imaging of the blood flow to the~     heart muscle) ordered by their medical doctors. As part of the SPECT scan, they will have~     been given a drug called regadenoson to widen and expand the blood vessels bringing blood to~     the heart muscle. The SPECT pictures of the heart are taken about an hour after the~     regadenoson is put into an arm vein through an IV. In this study, additional echo pictures~     will be taken and compared to the SPECT pictures.~      The aim of the study is to see if the echo pictures work as well as SPECT to measure the~     blood flow to the heart muscle.~   "
184442|NCT01150565|"~     The purpose of this study is primarily to evaluate the safety and tolerability of two dose~     levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to~     severe symptoms of interstitial cystitis.~   "
184443|NCT01150552|"~     The main focus of the study is:~        -  To estimate seroprevalence of AI in poultry-exposed and non-exposed human populations.~        -  To estimate the incidence of AI in poultry-exposed and non-exposed human populations.~        -  To investigate risk factors associated with AI infections in occupationally-exposed~          poultry workers.~      The secondary objectives of the study:~        -  To investigate patterns in transmission of AI to household contacts of AI clinical cases~        -  To isolate AI viruses from acute cases~        -  To monitor the pathogenicity and disease severity of AI viruses causing human infections~   "
184444|NCT01150539|"~     The effects of a 16-week exercise training program on insulin resistance and adiposity in~     overweight/obese women with Polycystic ovary syndrome (PCOS).~   "
184445|NCT01150526|"~     The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage,~     diminish inflammatory response, and improve muscle strength recovery following an acute~     exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as~     either a single dose before a bout of acute exercise or in multiple doses (one before and~     three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in~     free acid gel will result in less muscle damage, diminished inflammatory response, and~     improved muscle strength recovery than either a placebo or CaHMB treatment following a bout~     of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for~     muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and~     IL-18); and (3) muscle strength recovery and soreness.~   "
184446|NCT01150513|"~     Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no~     standard regimen. Some data showed that platins could improve the efficacy of advance TNBC.~     In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better~     efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).~   "
184447|NCT01150500|"~     The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting~     Coronary Stent in the treatment of de novo lesions in native coronary arteries with a~     reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.~   "
184448|NCT01150487|"~     The aim of this study is to determine the validity of two tests on bone marrow of sensitized~     kidney transplant recipients in order to better understand why these patients with antibodies~     against their donors are at a greater risk of rejection of their transplanted organs.~   "
184449|NCT01150474|"~     Our primary aim is to determine whether the routine use of belladonna and morphine~     suppositories will improve pain control following vaginal surgery. Treatment will begin~     immediately following surgery and every 8 hours for 16 hours.~   "
184450|NCT01150461|"~     The purpose of this study is to determine whether taking losartan helps people with~     hypertrophic nonobstructive cardiomyopathy feel better by decreasing the amount of heart~     muscle thickening and/or the amount of heart muscle scarring.~   "
184452|NCT01150435|"~     Mobility is a contributing factor in today's society. Drug dependence displays not only a~     medical but also an economic problem: Especially for an intended reintegration of a drug~     dependant patient in maintenance therapy the possession of a driving licence could be~     decisive for a job allocation and therefore the intended reintegration to society.~      Subject of this study was to verify if patients under substitution therapy with R, S-~     Methadone, S- Methadone, Buprenorphine and Buprenorphine plus Naloxone are just as fit to~     drive a car as a non drug dependent person.~      For this investigation we compared 121 drug dependent patients in stable maintenance therapy~     for a minimum of two years without consumption of any other psychotropic substances than~     their maintenance drug (including THC) with non- drug dependant subjects of the same gender,~     age and level of education.~      This is the largest study on this topic worldwide. The neuro- cognitive working order was~     tested by means of the Vienna Test System an objective, reliable and valid test quantifying~     reaction time, attention efficiency, concentration, maximum resilience and orientation.~     Current use of any other psychotropic substance or alcohol just as any serious illness~     (including psychiatric diseases, except for an effectively treated depression) lead to~     exclusion from this study.~   "
184453|NCT01150422|"~     This trial will compare the efficacy and acceptability of post-medical abortion follow-up by~     assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy~     test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine~     follow-up visit including a bimanual exam and vaginal ultrasound.~      The goal of the study is to provide answers to the following questions:~        1. Is a follow-up protocol that employs a self-administered questionnaire and at home use~          of a semi-quantitative pregnancy test effective at identifying women with ongoing~          pregnancies?~        2. Is an innovative follow-up protocol more acceptable to women and providers than the~          current standard of care?~        3. Is an innovative follow-up protocol feasible to implement in abortion services in~          Vietnam?~   "
184454|NCT01150409|"~     The proposed study will evaluate the potential benefit of a tapered course of hydrocortisone~     compared to abrupt cessation in patients initiated on hydrocortisone for septic shock. The~     study will include adult patients in the medical intensive care unit (MICU) who meet criteria~     for corticosteroid therapy for septic shock according to the current MICU protocol.All~     patients will receive 7 days of hydrocortisone (50mg/Q6hrs) as part of the routine management~     of septic shock, before being randomly assigned to receive hydrocortisone taper versus no~     taper. The primary study endpoint is the incidence of hypotension within 7 days after~     randomization. Secondary endpoints will include incidence of adrenal insufficiency, and~     changes in the inflammatory status (assessed by cytokine measurements) before, during, and~     after corticosteroid discontinuation. The cytokines to be measured include IL-1, IL-6, IL-9,~     IL-10, and TNF. Since there has not been a randomized clinical trial to investigate the~     potential benefit of weaning septic patients off low-dose hydrocortisone as opposed to~     stopping abruptly, this study has potential to change clinical practice by leading to a~     consistent approach of corticosteroid discontinuation and to a better understanding of their~     impact on the inflammatory modulation in septic shock.~   "
184455|NCT01150396|"~     Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled.~     Fetal circulation will be studied and blood for inflammatory parameters will be collected. If~     birth occurs before 28 weeks, detailed information on clinical course of the newborn until~     discharge from the neonatal intensive care unit will be recorded,and specimens of amniotic~     fluid, placenta, blood and urine will be collection for inflammatory parameters. After~     discharge the children will be followed according to a specific protocol until 5 years of~     age.~   "
184456|NCT01150383|"~     Chronic obstructive pulmonary disease (COPD) is number four of the leading causes of death in~     the USA and Europe. Moreover, among the top five causes of death, this disease is the only~     one with increasing mortality rates. Physical training has become an evidence based~     therapeutic intervention in these patients.~      In this study the investigators aim to establish if supplemental oxygen during strength and~     endurance training improves exercise tolerance. Furthermore, the investigators want to~     research, if supplemental oxygen has the ability to increase training intensity, which would~     lead to a greater training effect with respect to respiratory, vascular, inflammatory and~     anthropometric parameters, as well as quality of life.~      SCOPE is a prospective, randomized, double-blinded, controlled, cross-over trial. The~     investigators aim to enroll 40 patients suffering from COPD aged >30 years. Inclusion~     criteria are FEV1 30-60%, and PO2 at rest >55 mmHg. At baseline, patients will undergo~     pre-tests including pulmonary, exercise physiological and medical investigations. Prior to~     the exercise training, an intervention-free control period with usual care is planned. This~     will be followed by 2 x 6 weeks with physical training (ergometer based endurance training~     and strength training, using weight lifting machines) with either supplemental oxygen or~     usual room air (e.g.: first 6 weeks of exercise with oxygen supplementation followed by 6~     weeks of room air). After the initial control period and between these two exercise periods,~     patients will be tested as described in pre-tests, and at the end of the second exercise~     training period. In addition, the investigators will assess changes in lung function and~     symptomatic dyspnoea, as well as in quality of life (St. George's Respiratory Questionnaire).~      Within this study, the investigators hope to improve rehabilitation programs for COPD~     patients.~   "
184457|NCT01150370|"~     The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the~     safety and efficacy of the circumcision device for applying it to the national scale up of~     adult male circumcision in Rwanda~   "
184458|NCT01150357|"~     This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering~     effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid~     and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid~     dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600~     mg of aliskiren. This study is being conducted to support monotherapy registration of~     aliskiren for the treatment of hypertension in children 6-17 years of age.~   "
184459|NCT01150344|"~     Riamet® or Malarone® are both recommended as the first line treatment for uncomplicated~     malaria in France, according to the French consensus Conference revised in 2007 on the~     treatment of imported malaria.~      The aim of the study is to compare both tolerance and efficacy of Malarone® and Riamet® in~     the treatment of uncomplicated imported malaria and to determine clinical and parasitological~     predictive factors associated with a less effectiveness. It's a multicentric, randomised~     study in adults with uncomplicated malaria. Treatment will be administered for 3 days, and~     patients will be followed for 28 days, to evaluate the therapeutic evolution. 640 patients~     will be included among 15 centres.~   "
184460|NCT01150331|"~     Compare the efficiency of the association, first line, the intravenous levetiracetam and the~     intravenous clonazepam, in that of a monotherapy of clonazepam intravenous in the~     pre-hospital treatment of tonicoclonic generalised status epilepticus.~   "
184461|NCT01150318|"~     Papillary cancer may affect patients of any age,with a good prognosis. Most of young patients~     may hence procreate as often as the general population.131iodine is an essential tool during~     treatment of thyroid cancer. According literature data, 131iodine given patients may~     experience exocrine testicular dysfunction with transient azoospermia, as a significant~     growing number of Desoxyribonucleic acid (DNA) damage may concern the patient or his~     offspring. The primary purpose will be to study a genomic instability within the germinal~     line, based on a significant mutation rate analysis in their minisatellites regions after 100~     mCi 131 iodine irradiation compared to the baseline spermogram of each patient, thus being~     his own control case in a cross-over study.The inclusion of 50 patients treated by surgery~     prior to131iodine would result in statistically significant results.This multicentric~     cross-over study with a multidisciplinary approach will act for a direct benefit on testis~     function in patients aged 18-45 treated by 131iodine for thyroid cancer. Samples measurements~     timing will be: after surgery, 2 and 12 months after 131iodine administration.~   "
184462|NCT01150305|"~     Hearing impairment is a common disorder that affects at least 7% of individuals in our~     countries. Even the causes of hearing impairment are numerous, genetic causes represent the~     main factor of sensorineural deafness. Among hereditary non-syndromic deafness~     autosomal-dominant inheritance is observed in about 10-20% of the cases. These forms of~     deafness are usually post-lingual and progressive. To date more than 41 chromosomal~     localisation and 21 genes associated to non syndromic dominant deafness have been described.~     It represents an extreme genetic heterogeneity making difficult the studies of these forms of~     hearing impairment. But, genetic diagnostic testing is crucial in these cases. Indeed,~     therapeutic research are in the way to prevent the progression of the disorder. The aim of~     this work is to establish the prevalence of the different genes involved in these forms of~     deafness.~   "
184463|NCT01150292|"~     Aim: to determine the effects of DHA supplementation:~        -  on the platelet function through their aggregation and the pathway of arachidonic acid~          metabolism~        -  on redox status on cells and plasma~        -  on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400~          mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out~          period of 6 to 9 weeks.~   "
184464|NCT01150279|"~     This study will examine the feasibility, acceptability and usability of a semi-quantitative~     urine pregnancy test (dBest One Step hCG Panel Test Kit) for at-home follow-up after early~     medical abortion using mifepristone+misoprostol. The study seeks to:~        1. Assess the feasibility of using this test in lieu of standard one-week clinic-based~          follow up for determination of complete abortion status as part of normal service~          delivery. In Mexico, follow up will be in two weeks, as is standard care in that .~        2. To determine if women using this test at home understand how to use it and can correctly~          interpret the results; is it practical.~        3. Assess women's and provider's acceptability of using at-home pregnancy tests in lieu of~          clinic-based follow up for confirmation of complete medical abortion in the future.~   "
184465|NCT01150266|"~     This is a pilot study of thrombolytic therapy in patients with ischemic stroke who present~     with stroke symptoms upon awakening.~   "
184466|NCT01150253|"~     Various studies in animals and humans have shown a potential beneficial effect of probiotics~     consumption on allergy. However, few studies exist that document their efficacy for upper~     airways allergies such as allergic rhinitis. The objective of this study is to investigate~     the effect of short-term oral administration of a Lactobacillus paracasei on a nasal~     provocation test (NPT) with grass pollen, performed out of pollen season. Adult volunteers~     with allergic rhinitis are enrolled in a randomized, double-blind, placebo-controlled study,~     based on two 4-weeks cross-over periods of product consumption (probiotic-fermented milk~     versus placebo), separated by a washout period of 6-8 weeks. Objective and subjective~     clinical parameters of NPT as well as systemic and nasal immunological parameters are~     compared between the two treatment periods.~   "
184467|NCT01150240|"~     A Swiss national, multi-centre, online patient and research database will be created, using~     the existing ESID database server system. This database contains disease-specific data from~     patients with primary (inborn) immunodeficiency diseases (PID).~   "
184468|NCT01150214|"~     This is a multi-center, observational, 1-year prospective cohort study (1 year follow-up, at~     3, 6 and 12 month) with approximately 675 participants. We will conduct a thorough outcomes~     assessment utilizing data from Magnetic Resonance Imaging (MRI) scans, as well as~     pre-procedure and follow-up data. Scans will be blinded to location of participating site.~     MRI scans will be sequenced and analyzed as they arrive from the database.~      Imaging Protocol: All patients will undergo a Delayed-Enhancement MRI (DE-MRI) within 30 days~     prior to the atrial fibrillation (AF) ablation procedure. The purpose of the initial MRI is~     to quantify the degree of atrial structural remodeling or fibrosis pre-ablation. Following~     ablation, DE-MRI will be obtained at 3, 6, and 12 months follow-up to detect and quantify~     ablation-related scar formation.~      Clinical Follow-up: The institution where the ablation was performed will continue~     post-procedural care following standard of care procedures.~      Atrial arrhythmia recurrences will be catalogued up to one year post-ablation and predictors~     of recurrences of AF will be determined by statistical analysis. The specific mechanism and~     electrophysiological characteristics of atrial arrhythmia recurrence will also be analyzed.~      Our hypotheses are (1) DE-MRI will reproducibly stage the progression left atrium fibrosis in~     AF; (2) DE-MRI will reproducibly aid in quantifying and identifying the distribution of~     catheter ablation-related scarring in the left atrium; and (3) the stage of left atrium~     fibrosis pre-ablation and the amount and location of scarring will predict success of~     catheter ablation therapy for AF.~   "
184469|NCT01150201|"~     Study objective: To investigate the potential anti-proteinuric and renoprotective efficacy of~     aliskiren in addition to losartan in patients at risk of developing end-stage renal disease~     (ESRD)~      Methods: This will be a randomized, double-blind study in which proteinuric, non-diabetic~     patients with chronic kidney disease (CKD) will be assigned in a 1:1 ratio to one of the~     following treatment groups for 3 years:~        -  Group A: Losartan (Control arm: conventional treatment)*~        -  Group B: Aliskiren plus Losartan (Intervention arm)*~             -  With optional addition of other anti-hypertensive agents to achieve an optimal~               target blood pressure of <130/80 mmHg.~   "
184472|NCT01150162|"~     A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta~     (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.~   "
184473|NCT01150149|"~     Most countries of the world, including the USA are making preparations for a possible~     influenza pandemic. Such an event will constitute a global public health emergency, but it is~     impossible to predict when this will happen. Up to 80 million people could die worldwide, so~     as much as possible needs to be done in advance to find ways of how the impact can be~     reduced. Although the investigators know that medical interventions such as anti-influenza~     drugs and antibiotics will be important, even in well resourced countries these might be in~     short supply. Vaccines will also be important but these will not be available until at least~     4-5 months after the pandemic has started. This means that other non-pharmaceutical measures~     could well be important such as social distancing, school closures and the use of face masks.~     Guidance also needs to be developed so that families can care for each other whilst~     minimizing the spread of infection. To do these things, the investigators need to know how~     influenza is transmitted from person-to person. This is poorly understood at present. The~     investigators also need to know if face masks work before recommendations for public use can~     be made. The best way to study influenza transmission and the effectiveness of masks is to~     perform a study using healthy adult volunteers. The investigators will do this by giving some~     volunteers normal influenza via nasal drops. When they get symptoms the investigators will~     create an 'experimental household' by getting them to live with other non-infected volunteers~     for 48 hours, in a specially designed quarantine isolation unit. Some of the non-infected~     volunteers will be unprotected; others will be selected randomly to wear either face masks or~     a special plastic 'cloak' so that they do not touch their faces; another group will wear~     both. The investigators will then measure the rate at which the different groups get 'flu'.~     From these data the investigators can work out whether it is touching the face or coughing~     and sneezing that spreads flu most or whether both are important; the investigators can also~     deduce how well face masks work to prevent spread. The investigators need almost 2000~     volunteers for this study, it will take at least 2 years to complete and it will be very~     costly, however, the results will be of global importance. If the study is successful, the~     investigators can tell governments around the world whether face masks work to prevent~     influenza and be clearer about the guidance that should be given to families.~   "
184474|NCT01150136|"~     Cystic fibrosis (CF) is the most common lethal, inherited disorder among Caucasians. Choline~     is an essential vitamin and as a methyl donor is critically needed to support the normal~     metabolism. Our previous studies have demonstrated that children with CF have depleted levels~     of choline. The purpose of this study is to gather data on the status of choline and related~     metabolites in children with Cystic Fibrosis by age and gender. The hypothesis for this study~     is that in children with CF, deficiency of choline and related metabolites will increase with~     increasing age.~   "
184475|NCT01150123|"~     This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.~   "
184476|NCT01150110|"~     The purpose of this study was to compare the effectiveness of soft occlusal splint therapy on~     the electromyographic activity of masticatory muscles (ateriors temporalis and masseter)~     before and after the application of a muscle relaxation splint. Electromyography recordings~     from the masseter and anterior temporalis muscles were analyzed quantitatively during maximal~     clench, rest and mastication usual, before and after the treatment without a splint. Ten~     patients whose chief complaint was Temporomandibular Disorders (TMD) were selected for the~     study. After the initial evaluations soft occlusal splints (muscle relaxation splints) were~     applied, and the patients were instructed to use the splints for four weeks. Surface~     electromyographic recordings were taken from each patient, as clinical evaluations of TMD~     (Index of Helkimo), both evaluations before the beginning of clinical therapy and after four~     weeks of wearing splints. The data obtained were analyzed by Wilcoxon´s and Friedman´s tests.~   "
184477|NCT01150097|"~     The reason for this extension is to evaluate the long-term safety and efficacy of two~     concentration-controlled everolimus regimen in de novo liver transplant recipients. The most~     important long-term safety assessments include evaluation of renal function, progression of~     HCV related allograft fibrosis, and other treatment related effects at Month 36~     post-transplantation compared to extension baseline (Months 24 post-transplantation).~   "
184478|NCT01150084|"~     Increasing rates of sedentary living, often complemented by obesity, among large segments of~     the adult population are associated with costs to individual health and well-being and~     thereby to society as a whole. Although some workplaces offer physical activity~     opportunities, those employees who tend to need it the most (i.e., the health needy) are~     often not attracted. In this project, the investigators propose to develop and evaluate a~     programme that is targeted to the sedentary health needy employees. The investigators will~     work with the corporate partner (a large university) to attract such employees through an~     extensive social marketing driven campaign. A 16-week lunchtime walking programme is proposed~     in which walking groups are offered followed by support and motivational strategies for~     longer term independent walking. The investigators will examine the effects of the programme~     on total amount of walking (including a follow-up assessment 4 months later) and will use~     innovative technology (Smartphones) to also examine the effect of lunchtime walks on~     well-being and work performance within and between participants.~   "
184479|NCT01150071|"~     Background: In a national Norwegian cohort of children born before 28 weeks gestation or with~     a birth weight less than 1000 g born in 1999 and 2000, 372 survived. Compared with earlier~     studies survival increased for the most immature infants, but at the cost of more early~     complications and a high rate of impairments, while the less immature children had fewer~     early complications and less impairments detectable within 5 years. These changes show the~     importance of monitoring outcome as treatment modalities change. Large brain haemorrhages~     were highly predictive of severe disabilities, but we have not found good predictive factors~     for milder impairments such as cognitive, behavioural and motor difficulties. However, at 5~     years later function may be difficult to predict, and the children's potentials are better~     understood after completing several years in school. Objectives: The children will be~     re-examined at age 11 in order to assess their physical and mental health, and cognitive,~     motor and social function, and to determine if early life events and development at 2 and 5~     years are predictive of long term health and functioning. MRI-studies, including functional~     MRI will be performed to examine if different outcomes related to brain function can be~     explained by differences in brain development. Methods: For all, data will be collected from~     the compulsory national test in 5th grade and questionnaires to the child, parents and~     teacher. For children in Western Norway (n=87) extensive examinations of lung and brain~     function, including clinical diagnostic tests and MRI, will be added. For all aspects of the~     study the investigators have appropriate current and historic reference populations for~     comparison. Implications: Knowledge on causes and of early predictions of outcome is needed~     to give appropriate advice to families, professionals and society, and to develop preventive~     programs.~   "
184480|NCT01150058|"~     RATIONALE: Studying cell samples from patients with cancer in the laboratory may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to cancer~      PURPOSE: This research study is studying drug biomarkers in cell samples from patients with~     acute myeloid leukemia.~   "
184497|NCT01149837|"~     The InnoLIA HTLV I/II Score is an in vitro diagnostic test for confirmation of antibodies to~     human T-cell lymphotropic virus (HTLV) type I and type II in human blood samples. It is~     intended as a supplemental test for blood donor samples that are reactive in routine~     anti-HTLV screening tests. This study will determine if the test is useful for donor~     counseling purposes.~   "
184568|NCT01148888|"~     The primary objective of this study is to determine whether magnesium sulfate has a~     clinically important effect on the amplitude and latency of somatosensory and motor evoked~     potentials in patients undergoing surgical correction of idiopathic scoliosis.~   "
184481|NCT01150045|"~     PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium,~     and fluorouracil together to compare how well they work when given together with or without~     celecoxib in treating patients with stage III colon cancer previously treated with surgery.~      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. It is not yet known whether giving~     oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib~     in treating colon cancer.~   "
184482|NCT01150032|"~     QUALYOR is a prospective study on the predictive value for fragility fracture of various new~     techniques assessing bone quality, among postmenopausal women with low bone mass.~   "
184483|NCT01150019|"~     Vascular inflammation is a key factor in both the pathogenesis and outcome of~     atherosclerosis.Resistin was shown to induce vascular endothelial dysfunction and vascular~     smooth muscle cell proliferation.~      18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for~     identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore,~     the purpose of the study is to demonstrate the correlation between circulating resistin and~     vascular inflammation detected by 18FDG-PET in obese persons.~   "
184484|NCT01150006|"~     The inflammatory state and composition of atherosclerotic plaques are considered the main~     contributing factors responsible for acute cardiovascular events, rather than the degree of~     stenosis. Recently, positron emission tomography (PET) with 18F-fluoro-deoxyglucose (FDG) has~     been suggested as a promising novel imaging technique to identify the inflammatory state of~     atherosclerotic plaque. Recently, a few clinical studies showed that circulating A-FABP level~     had a close relation with the development of atherosclerosis in human. Therefore, in the~     present study, the investigators examined the relationship between circulating A-FABP and~     vascular inflammation of carotid arteries measured using FDG-PET in healthy male subjects.~   "
184485|NCT01149993|"~     Patients undergoing living donor renal transplant will be asked to participate to determine~     whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving~     an additional dose of antibody induction therapy helps to alleviate potential damage to the~     transplanted organ post-transplant. A number of lab tests will be done post-transplant to~     determine how well the kidney is functioning.~   "
184486|NCT01149980|"~     This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's~     Laboratories Limited under fed conditions.~   "
184487|NCT01149967|"~     This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's~     Laboratories Limited under fasting conditions.~   "
184488|NCT01149954|"~     The purpose of this study is to compare the rate and extent of absorption of ibuprofen 200 mg~     gelcaps (test) versus Advil liquigels (reference) administered as 1 x 200 mg gelcap under fed~     conditions.~   "
184489|NCT01149941|"~     The purpose of this study is to compare the rate and extent of absorption of ibuprofen 200 mg~     gelcaps (test) versus Advil liquigels (reference) administered as 1 x 200 mg gelcap under~     fasting conditions.~   "
184490|NCT01149928|"~     In this prospective, cross-sectional study, the aim was to investigate the possible role of~     cord stress hormones; adrenocorticotropic hormone (ACTH), cortisol, epinephrine, sT3, sT4,~     and thyroid-stimulating hormone (TSH) in the development of Transient Tachypnea of the~     Newborn (TTN), via their modulatory effect on epithelial sodium channels and Na-K-ATPase.~   "
184491|NCT01149915|"~     The primary objective of this study is to determine the maximum tolerated dose, dose limiting~     toxicity, safety and tolerability of TH-302 in patients with acute leukemias, advanced phase~     chronic myelogenous leukemia (CML), high risk myelodysplastic syndromes, advanced~     myelofibrosis or relapsed/refractory chronic lymphocytic leukemia (CLL).~   "
184492|NCT01149902|"~     The purpose of this study is to determine safety and feasibility of Chemo-Immunotherapy using~     cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients~     with relapsed and refractory head and neck squamous cell carcinoma.~   "
184493|NCT01149889|"~     The investigators purpose is to offer active Transcranial Direct Current Stimulation (tDCS)~     in patients of the investigators previous study who received either placebo or sertraline and~     have not responded.~   "
184494|NCT01149876|"~     The purpose of this study is to determine whether a topical Nu Skin product with or without a~     galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to~     an over the counter moisturizer and tretinoin cream.~   "
184495|NCT01149863|"~     Typically, the collection of blood cells for autologous stem cell transplant is done after~     the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to~     activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+~     cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis~     (removal of blood) begins the following morning. The purpose of this study is to test whether~     plerixafor can instead be given 17 hours before apheresis. This timing would be more~     convenient since plerixafor would be given during normal clinic hours, and so patients would~     be within a clinic environment if any side effects develop.~      The study will look for the activation of CD34+ cells in patients who receive plerixafor 17~     hours before apheresis. We will follow the number of patients that achieve the target numbers~     of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the~     numbers in previous studies giving plerixafor 11 hours before apheresis.~      We will also assess the safety of giving plerixafor 17 hours before apheresis.~   "
184496|NCT01149850|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     temozolomide, also work in different ways to kill tumor cells or stop them from growing.~     Giving bevacizumab together with temozolomide may be a better way to block tumor growth.~      PURPOSE: This phase II trial is studying how well giving bevacizumab and temozolomide~     together works in treating older patients with newly diagnosed glioblastoma multiforme or~     gliosarcoma.~   "
185259|NCT01139762|"~     The purpose of this study is to investigate the efficacy and safety of once daily tadalafil~     when taken with finasteride as a treatment for men with signs and symptoms of Benign~     Prostatic Hyperplasia and demonstrable prostate enlargement.~   "
184498|NCT01149824|"~     In this study, our aim is to determine an active but tolerable sublingual dose (range 100 to~     4000 µg) of Salvinorin A (SA) in experienced subjects. This study is an ascending-dose,~     placebo-controlled, single-site design in 8 Salvia-experienced subjects. Subjects will~     receive SA doses from 0-4000 µg. Doses will be separated by at least one day. The first two~     doses (0 and 100µg) will be double-blinded while the last four (250, 500, 1000, 2000 and~     4000µg) will be single-blind.~   "
184499|NCT01149811|"~     The purpose of this clinical trial is to compare the safety and tolerability of two dose~     regimens of fipamezole in adult patients with Parkinson's Disease who are receiving levodopa.~   "
184500|NCT01149798|"~     This phase II trial on the assumption that abraxane and cisplatin combination therapy is~     efficacy in metastatic breast cancer.~   "
184501|NCT01149785|"~     The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the~     single dose pharmacokinetics of crizotinib in healthy volunteers.~   "
184502|NCT01149772|"~     The current study seeks to test the effectiveness of a talk-therapy intervention designed to~     better meet the needs of chronically ill Veterans. This project looks to recruit 450 Veterans~     with either chronic obstructive pulmonary disease (COPD) or heart failure (HF) who also have~     symptoms of worry, stress, anxiety, or sadness. Participants will be randomly put into either~     the talk-therapy intervention or enhanced usual care.~      The talk therapy intervention will be provided by VA clinicians in the primary care setting~     and will consist of 6 core meetings (30-45 minutes in duration) and 2 follow-up telephone~     meetings. Enhanced usual care participants will receive feedback regarding the assessment~     findings and educational materials on COPD and/or HF, depression and anxiety.~   "
184503|NCT01149759|"~     Atopic Dermatitis (AD) or eczema is a chronic relapsing inflammatory disease that affects~     1-3% of the adults and up to 25% of the children in the United States. Patients with severe~     AD will be studied during a 24-week study with systemic cyclosporine (Neoral, capsule form)~     to evaluate the immune suppression and pathological correlation of cyclosporine A in these~     patients in order to determine the extent to which immune activation drives the pathological~     epidermal phenotype.~   "
184504|NCT01149746|"~     The objective of this study is to evaluate the comparative bioavailability between Tamsulosin~     Hydrochloride 0.4 mg Capsules (Teva Pharmaceuticals USA) and Flomax® 0.4 mg Capsules~     (Boehringer Ingelheim Pharmaceuticals, Inc. USA), after a single-dose in healthy subjects~     under fasting conditions.~   "
184505|NCT01149733|"~     The objective of this study is to evaluate the comparative bioavailability between tamsulosin~     hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.;~     distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg~     capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer~     Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed~     conditions.~   "
184506|NCT01149720|"~     This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with~     an extension phase design in which the steady state PK of ARQ 197 will be investigated using~     the tablet administered in fed state (test treatment) and capsule administered at least 1~     hour before or 2 hours after a meal (reference treatment) in subjects with advanced solid~     tumors.~   "
184507|NCT01149707|"~     PUR 0110 is a 100% natural novel investigational medicinal product that has been demonstrated~     in several in vitro and in vivo pharmacology studies to have potent anti-inflammatory,~     anti-oxidative and immunomodulatory effects. This exploratory Phase 2a study is a~     first-in-patient study to evaluate the safety, tolerability, biomarker effect and efficacy of~     PUR 0110 rectal enema in patients with active mild-to-moderate distal ulcerative colitis~     (UC).~      The study is a multicenter, randomized, double-blind, parallel-group, dose-ranging,~     placebo-controlled study. To be eligible for inclusion into the study, patients must either~     be newly diagnosed or have on-going active mild-to-moderate distal ulcerative colitis of at~     least 3 months duration confirmed in either case by flexible sigmoidoscopy and biopsy at the~     Screening Visit. In addition, patients must have a modified Mayo score of ≥5 to ≤10 including~     a sigmoidoscopy inflammation grade and rectal bleeding scores of ≥2 each. Eligible patients~     will be randomly assigned to receive either PUR 0110 250 mg, 500 mg or 1000 mg or placebo~     rectal enema in a 1:1:1:1 ratio. Patients will self-administer the assigned study medication~     intrarectally once-daily at bedtime (10:00 p.m +/- 1 hour) for 2 weeks.~      Patients will be evaluated for safety by adverse events, clinical laboratory tests, vital~     signs, physical examination, electrocardiogram (ECG), and concomitant medications. Efficacy~     evaluations will include the modified Mayo score, patient-defined response and remission,~     Investigator Assessment of Ulcerative Colitis Symptom Score, Inflammatory Bowel Disease~     Questionnaire (IBDQ), and biomarkers of inflammation, apoptosis and total cell death, lipid~     peroxidation and in vivo oxidative stress, and antioxidant defense mechanisms in plasma,~     serum, urine, feces and biopsy tissue. Patients will have a flexible sigmoidoscopy and biopsy~     12 hours after the last dose of study medication.~   "
184508|NCT01149694|"~     This is a first-in-man study of a novel investigational botanical drug complex, PUR 0110~     rectal enema, that has been shown to have potent anti-inflammatory, antioxidant and~     immunomodulatory effects following in vitro and in vivo pharmacology studies, to assess the~     safety and tolerability of sequential single-ascending doses in normal healthy volunteers and~     to determine the maximum tolerated dose (MTD). As a tertiary objective, the study will also~     investigate the presence of specific pharmacokinetic markers following the administration of~     single-dose PUR 0110 at each dose level.~      The study is designed as a single-center, randomized, double-blind, parallel-group,~     sequential single-ascending dose, placebo-controlled safety, tolerability and pharmacokinetic~     study of PUR 0110 rectal enema in 24 normal healthy male volunteers. Eligible subjects will~     be randomly assigned to 4 Cohorts of 6 subjects each to receive active drug (PUR 0110 Enema)~     or placebo enema as follows: 187.5 mg/60 g - Cohort 1, 375 mg/60 g - Cohort 2, 750 mg/60 g -~     Cohort 3 or 1500 mg/60 g - Cohort 4. Within each Cohort, subjects will be randomized in a 2:1~     ratio to receive either active treatment (PUR 0110 enema; n = 4) or placebo enema (n = 2).~     Each subject will receive only 1 dose of assigned study medication and dosing of subjects~     within each cohort will also be by sequential inclusion.~   "
184509|NCT01149681|"~     This is an open-label, Phase II Clinical Trial of Aplidin® (plitidepsin) in Patients with~     Primary Myelofibrosis and post polycythemia vera/essential thrombocythemia (Post-PV/ET)~     Myelofibrosis.~   "
184510|NCT01149668|"~     The purpose of this study is to determine the long-term (> 6 months) safety of PCI 24781 PO~     in subjects with lymphoma.~   "
184569|NCT01148875|"~     RATIONALE: Mammography reminders may encourage women to undergo regular mammography~     screenings for breast cancer.~      PURPOSE: This randomized clinical trial is studying three different mammography reminder~     interventions to compare how well they work in encouraging women to undergo regular~     mammography screenings for breast cancer.~   "
184511|NCT01149655|"~     This will be a randomized, double-blind, placebo-controlled study consisting of a screening~     period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind~     maintenance treatment phase (Phase 3), and a follow up period.~      Subjects may be either outpatients or inpatients between screening and through the time they~     reach stabilization at the end of Phase 2; hospitalization is not a study requirement.~     However, eligible subjects must be outpatients at the beginning of Phase 3.~      Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and~     3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be~     encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any~     tolerability issues. The investigator will also have the option to phone the subjects and~     their guardian(s) at any time to ensure clinical stability.~      A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing~     the interim analysis. One interim analysis is planned after 75% of the total expected number~     of impending relapse events (28 events) are achieved and will be conducted by an independent~     data analysis center. The DMC will make a recommendation about stopping or continuing the~     study based on safety and efficacy reviews. The results of the interim analysis and~     individual subject data will remain blinded to the sponsor during the course of the study~     until the DMC determines that the study will conclude based on the results of the interim~     analysis, or the study is completed after 37 endpoint events.~   "
184512|NCT01149642|"~     This randomised, double-blind study will compare an oral immunomodulatory solution to a~     placebo for the prevention of acute severe mucositis in head and neck cancer patients treated~     surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of~     25% of severe acute mucositis in experimental arm.~   "
184513|NCT01149629|"~     One purpose of this study is to determine if taking droxidopa after eating will have an~     effect on how the body processes (absorbs and eliminates) the drug in healthy elderly~     subjects. Another purpose of this study is to see how the body processes (absorbs and~     eliminates) one 300mg capsule compared to three 100mg capsules. This study will also evaluate~     how well the body processes (absorbs and eliminates) and tolerates droxidopa when a 300 mg~     capsule is given 3 times a day for a total dose of 900 mg over the course of one day.~      Droxidopa is used to treat low blood pressure upon standing in patients with diseases of the~     nervous system, to prevent low blood pressure in patients with kidney disease during~     hemodialysis (removal of waste products of the blood), and to treat frozen gait (walking,~     stepping or running) and dizziness upon standing in patients with Parkinson's disease.~   "
184514|NCT01149616|"~     The purpose of the study is to determine the opiate sparing effects of intravenously~     administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with~     well known antiemetic effects. However, the analgesic effects of dexamethasone have not been~     adequately researched. Following surgery, patients are typically discharged home with PO~     opiates to manage post-operative pain. The investigators believe that by using VAS (Visual~     Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can~     reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1)~     when compared to placebo.~   "
184515|NCT01149603|"~     Purpose: The purpose of the Destination Therapy Evaluation for Failing Fontan Study (DEFINe~     Study) is to perform a single center physician-investigator led feasibility study to initiate~     examination of the safety and efficacy of implanting continuous flow circulatory support~     devices in 20 patients with failing Fontan physiology, not amenable to other surgical or~     medical therapy and who are not candidates for heart transplantation. Based upon the results~     of the DEFINe study, consideration would be given to a larger multicenter study. The primary~     endpoint is survival without a disabling stroke at two years. Safety, functional status,~     total days alive following hospital discharge and quality of life assessments will be~     evaluated as secondary endpoints.~      Background: Patients born with the congenital anomaly of a single ventricle often undergo~     Fontan procedures to improve oxygenation and circulation. As the patient matures, the~     benefits of the Fontan procedures become exhausted. These patients present as young adults~     with heart failure, and should be considered for heart transplantation. Failed Fontan~     physiology patients are now more commonly surviving into their 30s and 40s due to the~     advancement in surgical Fontan procedures over the last several decades. Yet, many patients~     are not appropriate transplant candidates due to progression of pulmonary failure that~     surpasses the pulmonary vascular resistance limits, end organ failure effects to the liver,~     and cardiac failure that does not present with left ventricular ejection fractions of less~     than 25%. Congenital heart disease is considered a higher risk indication for~     transplantation. Such patients present a complex anatomy, scar tissue from prior procedures,~     unique pathological states and limited ability to assess hemodynamics.~      Methods: Patients with failing Fontan physiology will be evaluated for surgical intervention,~     heart transplantation or participation in the study for long-term support, known as~     Destination Therapy (DT). Patients who do not meet the study criteria will be asked to~     participate in a sub-study to collect patient information. Consenting patients who meet the~     study criteria will be implanted with a HeartMate II Ventricular Assist Device (VAD) to~     improve cardiac output. Following VAD implantation, the patient will recover in the hospital,~     and then discharge to home or an approved facility. Study data will be collected as long as~     the patient receives VAD support. Placement of the VAD and continuing patient care should~     improve cardiac output and quality of life for this population of patients born with the~     congenital anomaly of a single ventricle.~      Outcomes: The primary endpoint of the study is to examine survival without a disabling stroke~     at two years (defined as a score of four or greater on the Modified Rankin Scale). Safety,~     functional status, total-days-alive following hospital discharge, and quality of life~     assessments will be evaluated as secondary endpoints.~   "
184516|NCT01149590|"~     The primary objective of the study is to see if coronary artery calcium score and computed~     tomography coronary angiogram alters the proportion of patients diagnosed with angina due to~     coronary heart disease.~   "
184517|NCT01149577|"~     Acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep~     disturbances in previously medicated schizophrenia patients with predominantly negative~     symptoms. The present study will be carried out to clarify the effect of olanzapine on~     polysomnographic profiles of schizophrenia patients in an acute phase of illness after~     controlling for the drug effects.~   "
184528|NCT01149434|"~     The study consists of two parts: Drug Interaction (Pharmacokinetic) Phase and Pharmacodynamic~     Phase~      The primary study objective for the Drug Interaction Study is to determine the~     pharmacokinetic interactions between RAD001 and JI-101.~      The primary study objective for the Pharmacodynamic Study is progression-free survival at 2~     moths, evaluated separately in each of the three cohorts.~      These will include a determination of tumor response using Response Evaluation Criteria in~     Solid Tumors (RECIST) Criteria and an assessment of ephrinB4 expression in blood samples.~      Secondary objectives are to determine safety and tolerability of JI-101. The investigational~     products are everolimus (42-O-(2-hydroxyethyl) rapamycin) and JI-101~     (1-[1-(2-amino-pyridin-4-ylmethyl)-1H-indol-4-yl]-3-(5-bromo-2 methoxy-phenyl)-urea)~      Eligible patients meeting all study entry criteria will be enrolled in the study. For the~     Drug Interaction study, patients with solid tumors will receive a single dose (10 mg) of~     Everolimus by mouth on Day 1 and Day 8 and JI-101 capsules (200 mg) by mouth on Day 8 and Day~     15. For the Pharmacodynamic Study, all patients will receive JI-101 capsules by mouth (200 mg~     BID) for 28 day treatment cycles.~   "
184518|NCT01149564|"~     Background:~      Patent ductus arteriosus (PDA) continues to be one of the most common problems in premature~     infants. Pharmacological closure of PDA with intravenous (IV) indomethacin was first reported~     in 1976, however, concern remains regarding the safety of indomethacin, which affects renal,~     GI and cerebral perfusion and may lead to complications such as transient or permanent renal~     dysfunction, NEC, GI hemorrhage, and reduced cerebral oxygenation. Recently, IV ibuprofen has~     been shown to be effective for the closure of patent ductus arteriosus in premature infants,~     without reducing mesenteric, renal, or cerebral blood flow. We have developed the~     echocardiographic PDA flow pattern as a guide for PDA treatment, fewer doses of drugs were~     needed to achieve acceptable closing rates. We have also reported that IV ibuprofen is as~     effective as IV indometacin for the PDA treatment in extremely premature infants, without~     increasing the incidence of complications in a randomised controlled trial. Several studies~     reported that oral ibuprofen may be effective for PDA treatment. To date there is no firm~     conclusion as to the efficacy and safety of oral ibuprofen compared with IV ibuprofen for PDA~     closure in extremely premature infants.~      Objective:~      Since the efficacy of pharmacological closure of PDA is related to gestational age, and~     extremely premature infants carry the highest rate of mortality and morbidity. We intend to~     conduct a randomized controlled trial to compare oral and intravenous ibuprofen for treatment~     of PDA in this high-risk population of extremely premature infants.~      Methods:~      Extremely premature infants (gestational age < 28 weeks) admit to the NICU will be eligible~     for enrollment. Informed parental consent will be obtained according to the Institutional~     Review Board's instructions. Extremely premature infants with respiratory distress syndrome~     (RDS) and PDA confirmed by echocardiography will be randomly assigned to receive either oral~     or IV ibuprofen. The subsequent doses of ibuprofen are also determined according to our~     specific echocardiographic PDA flow patterns at intervals of once every 24 hours from the~     last dose. The dosage of oral or ibuprofen is 10 mg/kg (1 ml) and then 5 mg/kg at 24-hour~     intervals as indicated by echocardiographic PDA flow pattern.~      Sample Size Calculation and Length of the Study Period:~      About 50-60 extremely premature infants will be admitted to our NICU each year. To prove with~     McNemar's Test at a one-sided significance level of 5% and a power of 90% that using oral~     ibuprofen instead of IV ibuprofen results in comparable PDA closure rates, only 31 extremely~     premature infants with RDS and PDA have to be enrolled. Allowing for attrition and exclusion~     from the final study groups, the length of the study period will be safe to set to 2 years.~      Expected Results:~      We expect to determine whether oral ibuprofen is effective and safe in inducing PDA closure~     in extremely premature infants and to compare the complications between infants treated with~     oral ibuprofen and those with IV ibuprofen.~   "
184519|NCT01149551|"~     The purpose of this study is to detect genetic associations for the development of~     schizophrenia (SZ) and bipolar illness (BP) by comparing Veterans with these diseases to~     psychiatrically healthy Veterans from Veterans Health Administration medical centers. In~     addition, the genetic basis for functional capacity and disability in Veterans affected with~     SZ and BP will be assessed, as will genetic predictors of suicidality and tardive dyskinesia.~     Finally, we will also establish a repository which allows for future genomic studies related~     to SZ, BP, and related disorders or sequelae.~   "
184520|NCT01149538|"~     The purpose of this study is to determine if choline bitartrate can be administered daily to~     children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain~     development and cognitive functioning.~   "
184521|NCT01149525|"~     The objective of this study is to evaluate the efficacy of L-carnitine versus placebo in the~     treatment of fatigue in multiple sclerosis patients. This study will randomize 60 patients in~     a cross-over design. This study is sponsored by academic French health institutions.~   "
184522|NCT01149512|"~     The majority of data documenting the outcomes for the adjustable gastric band (LAGB)~     originate from non-publicly funded surgical centres. The investigators aim to investigate the~     clinical outcomes of LAGB from a publicly funded Canadian obesity management program. This~     program recognized obesity as a chronic disease, providing extensive pre-operative~     multidisciplinary assessment and long term patient follow-up. Patients are selected for~     surgical management carefully by a multidisciplinary team and the LAGB is presented as one~     option to surgical management. Further, the investigators will investigate the operational~     impacts, including direct and indirect costs related the LAGB, to determine long term impacts~     on publicly funded hospitals within Canada.~   "
184523|NCT01149499|"~     The objective of this study is to compare the rate and extent of absorption of valacyclovir~     1000 mg tablet (test) versus Valtrex (reference), administered as 1 x 1000 mg tablet under~     fasting conditions.~   "
184524|NCT01149486|"~     The object of this study was to compare the relative bioavailability (rate and extent of~     absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva~     Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of~     Hyzaar® 100/25 mg Tablets distributed by Merck & Co., Inc. following a single oral dose (1 x~     100/25 mg tablet) in healthy adult subjects administered under fasting conditions.~   "
184525|NCT01149473|"~     The objective of this study is to compare the relative bioavailability of Losartan~     potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical~     Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg~     tablets (Merck) in healthy, adult, non-smoking subjects under non-fasting conditions.~   "
184526|NCT01149460|"~     The objective of this study was to compare the rate and extent of absorption of Teva~     Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir,~     administered as 1 x 1000 mg tablet under fed conditions.~   "
184527|NCT01149447|"~     Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous~     closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is~     secondary to a paradoxical embolism. After the PFO closure procedure a dual antiplatelet~     regimen is often prescribed for 3-6 months and several cardiologic and neurologic follow-up~     exams are scheduled in the first 12 months of follow-up. Usually a transthoracic +/-~     transoesophageal echocardiography (TTE +/- TEE) are performed at 6 months, however this kind~     of control is not systematically performed. In order to improve the clinical outcomes in this~     young patients' population, the investigators prospectively perform a complete cardiologic~     and neurologic follow-up program to all patients undergoing a successful percutaneous closure~     of a PFO.~      The aim of these controls is to confirm the good position of the PFO-device, to confirm the~     absence of any residual right to left shunt or any significant atrial arrhythmias Furthermore~     this prospective follow-up will analyze the possible mechanisms leading to a cerebral stroke~     recurrence (e.g. size of the PFO, presence of an atrial septal aneurysm, presence of a~     residual shunt, size of the utilized closure device, ....).~   "
184529|NCT01149421|"~     The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure~     and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants~     with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs).~   "
184530|NCT01149408|"~     The study aims at determining the feasibility of using maintenance Decitabine therapy~     following remission induction and consolidation in elderly Acute Myeloid Leukemia patients~     who are fit for aggressive therapy.~      Primary: Safety and tolerability of the decitabine regimen in the post remission state.~      Secondary:~        1. Disease-free survival - To determine the one-year disease-free survival in elderly~          patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine~          as post-consolidation maintenance therapy.~        2. Overall survival~   "
184531|NCT01149395|"~     The purpose of this research study is to determine in heartburn patients with nonerosive~     disease if detecting the presence of a fragment of the protein e-cadherin in esophageal~     epithelium or the amount of fragments of e-cadherin in blood can be used to monitor healing~     of esophagitis treated with a proton pump inhibitor (PPI). The hypothesis is that the~     presence of fragments of e-cadherin in esophageal epithelium or the amount of fragments of~     e-cadherin in blood can you useful as a biomarker for the healing of esophagitis in patients~     successfully treated with a PPI.~   "
184532|NCT01149382|"~     Influenza virus is an important cause of morbidity in the transplant population and can lead~     to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for~     organ transplant patients, studies have shown that the standard inactivated influenza vaccine~     has poor immunogenicity in this population. The investigators plan to test the humoral~     response to vaccination and look at HLA upregulation~   "
184533|NCT01149369|"~     The principal objective of this multicenter, randomized, placebo-controlled trial is to~     evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with~     placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.~   "
184534|NCT01149356|"~     This partially randomized phase I trial is studying the side effects and the best dose of~     RO4929097 when given together with exemestane and to see how well it works compared to~     exemestane alone in treating premenopausal and postmenopausal patients with advanced or~     metastatic breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone~     therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body~     makes. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving exemestane together with RO4929097 may kill more breast cancer cells.~   "
184535|NCT01149343|"~     The purpose of this clinical study is to examine the safety, immunogenicity and clinical~     activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15~     Antigen-Specific Cancer Immunotherapeutic [ASCI]) administered as a first line treatment in~     patients with unresectable and progressive metastatic cutaneous melanoma.~   "
184536|NCT01149330|"~     The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%/Benzoyl Peroxide~     2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.~   "
184537|NCT01149317|"~     Chronic pain is a significant public health problem, associated with impairments of physical~     and psychological functioning. While a third or more of the general population may suffer~     from chronic pain, it is often under recognized and under treated in health care settings.~     Low income and minority samples experience disparities in the prevalence of chronic pain, in~     perceived access to effective pain treatment, and in consultations for pain. A great deal of~     literature suggests that acupuncture offers potential benefit in the management of chronic~     pain, but it is rarely available to low income patients. The Acupuncture to Decrease~     Disparities in Outcomes of Pain Treatment (ADDOPT) project will introduce and evaluate the~     addition of acupuncture to the management of chronic pain for ethnically diverse, low-income~     primary care patients. The project represents a collaboration between the New York City~     Research and Improvement Networking Group (NYC RING), a practice-based research network~     dedicated to decreasing health disparities through primary care research, the Continuum~     Center for Health and Healing,The Swedish Institute School of Acupuncture, and Pacific~     College of Oriental Medicine. Our intervention will involve addition of weekly acupuncture~     sessions at 3 urban primary care practices. During training sessions at each practice,~     primary care providers will become familiar with acupuncture and indications for referral.~     Patients will be eligible if they experience chronic pain due to neck pain, back pain, or~     osteoarthritis. Our process evaluation, guided by Glasgow's REAIM framework, will assess~     barriers to implementation and adoption of the intervention in busy urban practices and~     acceptability to patients and providers. The investigators will employ a quasiexperimental~     design to assess primary outcomes (pain and quality of life) and obtain preliminary estimates~     of secondary outcomes (health care utilization and costs) of the intervention at each health~     center. This design will permit comparison across sites to discern practice level differences~     in uptake and outcomes.~   "
184538|NCT01149304|"~     To evaluate whether a combination regimen of pentoxifylline, ursodeoxycholic acid and~     enoxaparin provides a protective effect on the liver parenchyma after high dose rate (HDR)~     brachytherapy.~   "
184539|NCT01149291|"~     The aim of this post-marketing observational study is to obtain further data on the long term~     use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in~     the normal clinical setting and according to the approved Summary of Product Characteristics~     for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The~     relation of the safety data to PTH (Parathyroid hormone) suppression over time will be~     evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be~     recorded.~   "
184540|NCT01149278|"~     The ideal mean arterial pressure in patients with septic shock is unknown. The expert's~     recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis~     are weak. Indead there are only few prospective studies which addressed this question without~     clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two~     levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)~   "
184541|NCT01149265|"~     The purpose of this study is to determine the effectiveness of online support groups for~     anxiety and depression.~   "
184542|NCT01149252|"~     The purpose of this study is to determine the safety and efficacy of a new product,~     Psoralait, as compared to a placebo in the treatment of psoriasis.~   "
184543|NCT01149213|"~     The investigators purpose is to follow remitted patients from their previous study using~     transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents~     relapse.~   "
184544|NCT01149200|"~     Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant~     IBS patients over a 28-day period.~   "
184545|NCT01149187|"~     Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis~     was noted on 15 to 60 percents in various studies.~      Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle~     biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but~     still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many~     cases.~      The aim of this study is to evaluate the usefulness of interferon-gamma release assay in~     addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules.~   "
184567|NCT01148901|"~     This trial is designed to measure improvement of hip involvement in patients with ankylosing~     spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab~     5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14,~     consistent with the approved dosing regimen described in the label. Participants will be~     evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses)~     of treatment. Further treatment after 4 doses is based on standard clinical practice as~     determined by the trial site.~   "
184546|NCT01149174|"~     Early single instillation of chemotherapy after TUR is recommended in the European~     Association of Urology Guidelines. Nevertheless, the procedure is suboptimal for patients~     with multiple tumors, sometimes is not tolerated and it can results in severe complications.~     In both laboratory and clinical studies, intravesical electromotive drug administration~     (EMDA) increases mitomycin-C (MMC) bladder uptake, resulting in an improved clinical efficacy~     in non-muscle invasive bladder cancer (NMIBC). The investigators will compare the effects of~     one immediate pre-TUR intravesical EMDA/MMC instillation with one immediate post-TUR~     intravesical passive diffusion MMC (PD/MMC) instillation and TUR alone in patients with~     NMIBC.~      All eligible patients with primary NMIBC will be randomized into 3 groups who will undergo~     transurethral resection alone (TUR/alone); TUR plus single immediate postoperative~     instillation (immediately after TUR) of 40 mg PD/MMC with a dwell time of 60 minutes; or~     single immediate preoperative instillation (immediately before TUR) of 40 mg EMDA/MMC with 20~     mA electric current for 30 minutes. Patients with intermediate and high risk NMIBC will~     undergo adjuvant intravesical therapy. The primary end points will be the recurrence rate and~     disease-free interval. All clinical analyses will be performed on an intent to treat basis.~   "
184547|NCT01149161|"~     Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role~     of lymph node dissection in the treatment of microPTC remains controversial. The~     investigators want to investigate the usefulness routine central dissection and sentinel~     lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study.~     The investigators started this study from May of 2009 and this study will be continued until~     Dec. 2011.~   "
184548|NCT01149148|"~     The investigators hypothesize that early intervention to optimize regional cerebral~     oxygenation detected by cerebral oximetry monitoring during deep hypothermic circulatory~     arrest (DHCA) for patients undergoing aortic surgery will decrease the incidence of transient~     and permanent neurological dysfunction and improve neurocognitive impairment.~   "
184549|NCT01149135|"~     One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal~     Affective Disorder(SAD) or so called winter depression is a disturbance of circadian rhythms.~     Since the circadian system is especially sensitive for the blue portion of the light~     spectrum, a new light therapy device with more blue light (blue enriched polychromatic light)~     was tested for its efficacy to treat SAD. In chronobiological terms this light is~     hypothesized to be more potent in inducing non-visual effects. In the present study~     fluorescent tubes that emit a high portion of short wavelength light on top of the normal~     wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour~     temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients.,In~     a earlier study it was shown that the therapeutic effect of blue enriched light were equal to~     standard light treatment using light in both conditions with an intensity of 10 000 lux. In~     the present study, blue enriched light with an intensity of 750 lux was used, because of the~     possible saturation effect in the former study. The investigators hypothesise that blue-~     enriched light with a low intensity improve the therapeutic effects of light treatment~     leading to a higher response or the same response in a shorter time schedule compared to~     standard light treatment.~   "
184550|NCT01149122|"~     The purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or~     without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic biliary~     tract carcinoma.~   "
184551|NCT01149109|"~     The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent~     therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60~     Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a~     previous non-randomized bicentric phase II trial, primary combination chemotherapy with~     lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et~     al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of~     CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the~     projected phase III trial confirms the phase II data, CCNU/TMZ combination would be~     significantly better than TMZ monotherapy and would thus be the new standard treatment for~     newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the~     potential to profoundly change the standard therapy of this most aggressive brain tumor.~     Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a~     benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months;~     Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the~     trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly~     diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6~     courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6~     weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming~     that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ)~     to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients~     have to be accrued. Patients will be accrued over 24 months and each patient will be followed~     for at least 24 months adding up to a total minimal duration of the time from first patient~     in until the end of the follow-up time of 48 months. The primary endpoint is overall~     survival; secondary endpoints include progression-free survival, response rate, acute and~     late toxicity, and quality of life.~   "
184552|NCT01149096|"~     This randomized clinical trial is studying the side effects of collection of bone marrow from~     donors treated with or without filgrastim. Giving colony-stimulating factors, such as~     filgrastim (G-CSF), to donors helps the stem cells move from the bone marrow to the blood so~     they can be collected and stored.~   "
184553|NCT01149083|"~     This phase II trial studies how well veliparib with or without carboplatin works in treating~     patients with stage III-IV breast cancer. Veliparib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known whether veliparib is more effective with or without carboplatin in treating breast~     cancer.~   "
184554|NCT01149070|"~     Human gonadotrophins have been successfully used for the treatment of infertility for more~     than 30 years. This observational study is being conducted to evaluate the efficacy and~     safety of the gonadotropins used for controlled ovarian stimulation (COS) in assisted~     reproductive technologies (ART).~   "
184555|NCT01149057|"~     This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra~     (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an~     inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs~     (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4~     weeks. Anticipated time on study treatment is 96 weeks.~   "
184556|NCT01149044|"~     This is an international, randomized, controlled, parallel group study in which patients with~     ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following:~     Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.~   "
184557|NCT01149031|"~     Provoked vestibulodynia, previously called vulvar vestibulitis syndrome, is clinically~     defined as chronic, unexplained, vulvar pain or discomfort confined to the vulvar vestibule~     in response to contact or pressure. In addition, many patients also have pain in response to~     non-sexual activities such as tampon insertion, gynecological examinations or physical~     pursuits such as bicycle riding; the severity of other vulvo-vaginal symptoms such as~     itching, burning and irritation varies. Once women with provoked vestibulodynia develop the~     syndrome, symptoms may last for months or years; as a result, provoked vestibulodynia has a~     profound effect on women's sexuality and psychological well-being. The diagnosis of provoked~     vestibulodynia is usually made by ascertaining if the patient fulfills modified Friedrich's~     criteria, consisting of 1) a history of vulvar pain, dyspareunia or pain with tampon~     insertion, 2) tenderness of the vestibule when being touched with a cotton-tip applicator and~     3) no identifiable cause for the pain.~      The etiology of this condition remains unknown. Proposed causes include chronic inflammation,~     peripheral neuropathy, genetic, immunologic and hormonal factors, infectious, psychological~     disorders, sexual dysfunction or disturbance in the central nervous system. Because the cause~     of provoked vestibulodynia remains unknown, many different treatments have been described for~     this condition, including topical and intra-lesional corticosteroids, topical anesthetics~     such as lidocaine, topical estrogen, topical or oral antidepressants or anti-convulsants,~     biofeedback or physical therapy, surgical resection of the involved tissue (vestibulectomy)~     and a variety of complementary and alternative therapies.~      Low level laser therapy (LLLT) is an emerging medical technique in which exposure to~     low-level laser light or light emitting diodes might stimulate or inhibit cellular function,~     possibly leading to beneficial clinical effects. Clinical applications that show some~     potential of effectiveness include treating soft tissue injury, chronic pain, and wound~     healing. The usage of low level laser therapy was found effective in various pain syndromes,~     and has no side effects.~      Since inflammatory mechanisms have been proposed in the pathogenesis of provoked~     vestibulodynia, and as there is no effective therapy for this syndrome, the investigators~     intend to study whether low level laser therapy might be an effective therapy for provoked~     vestibulodynia.~   "
184558|NCT01149018|"~     The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in~     patients suffering from Fibromyalgia~   "
184559|NCT01149005|"~     The purpose of the study is to evaluate whether insulin treatment during pulmonary~     exacerbation (PE) in patients with Cystic Fibrosis (CF)and normoglycemia improves their short~     term outcome by normalizing the glycemic profile and enhancing recovery. the investigators~     would like to evaluate whether insulin treatment during exacerbation improves both the~     general clinical condition of these patients and also has a protecting effect on ß-cells by~     preventing the deleterious effect of chronic hyperglycemia.~   "
184560|NCT01148992|"~     The purpose of this study is to assess potential interactions between intravenous (IV)~     cocaine and treatment with lofexidine.~   "
184561|NCT01148979|"~     This study aims to test the effect of a newly-approved stimulant medication, lisdexamfetamine~     dimesylate (Vyvanse), on specific residual symptoms of depression found in some patients who~     are undergoing treatment with, but have only partially responded to, a selective-serotonin~     reuptake inhibitor (SSRI) or selective-norepinephrine reuptake inhibitor (SNRI)~     antidepressant. Specifically, the investigators hypothesize that symptoms potentially related~     to deficient dopaminergic activity, such as lassitude, apathy, reduced positive affect and~     impaired executive function, in particular, will improve. This protocol is designed to test~     the hypothesis that this cluster of co-occurring residual symptoms sometimes found in treated~     depression will respond as a group to adjunctive psychostimulant therapy. The investigators~     propose to demonstrate this cluster of residual depressive symptoms and to measure the effect~     of stimulant therapy on it. The investigators hope to better understand the specific symptoms~     in this clinical population that are likely to improve with stimulant therapy.~   "
184562|NCT01148966|"~     This phase I trial is studying the side effects and best dose of aminolevulinic acid during~     surgery in treating patients with malignant brain tumors. Aminolevulinic acid becomes active~     when it is exposed to a certain kind of light and may help doctors find and remove tumor~     cells during surgery~   "
184563|NCT01148953|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of a single dose of ALN-TTR01 in patients with transthyretin (TTR) mediated~     amyloidosis (ATTR).~   "
184564|NCT01148940|"~     The purpose of this trial is to investigate D-Dimer levels, a surrogate marker of venous~     thromboembolism, in pregnant/postpartum white women as compared to pregnant/postpartum black~     women, and pregnant/postpartum women with sickle cell trait. The investigators will determine~     whether increased D-Dimer levels are reflected in a greater incidence of thrombosis in the~     postpartum patient, as well as the prevalence of symptomatic venous thrombosis in black~     patients as compared to pregnant white patients and women with sickle cell trait. The~     investigators will also investigate the effect of blood group on these parameters. If there~     is evidence that there is an increased risk of thrombosis in sickle cell trait, the~     investigators will plan a trial of prophylactic anticoagulation during the last trimester and~     the four weeks post partum for patients with sickle cell trait and compare this population to~     patients who do not receive prophylactic anticoagulation.~   "
184565|NCT01148927|"~     Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment~     results in adult ALL have lagged behind the improvements achieved in the pediatric~     population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used~     to treat adult patients with ALL. The results seem to be superior to those reported with~     other adult protocols. However, there is limited data on the impact of such intensified~     approaches and resulting toxicities on the quality of life (QOL) of these survivors.~     Identifying important factors affecting the QOL may permit attempts at early interventions~     and may help to further modify the regimen and mitigate these adverse effects on QOL.~      This study is evaluating the quality of life of long term survivors of adult ALL. It involves~     the patients filling out several questionnaires that are well-validated measures assessing~     various QOL issues of concern to these patients. The following questionnaires are used in~     this study:~        -  EORTC QLQ C30 to assess global health and major health domains~        -  Brief Pain Inventory (BPI)~        -  Personal Health Questionnaire (PHQ9) to assess psychosocial distress~        -  Functional Assessment of Cancer Therapy (FACT) Fatigue Questionnaire~        -  Peripheral Neuropathy Questionnaire~      The data obtained from the questionnaires will be analyzed and the various domains of health~     will be quantified.~   "
184566|NCT01148914|"~     This prospective study aims;~        1. To assess if pre-ablation levels of inflammatory biomarkers serve as independent~          predictors of procedure outcome~        2. To evaluate the inflammatory activation following catheter ablation by measuring~          serum-biomarker levels 24-hours after the procedure and examine the predictive role in~          procedure success~        3. To determine if a change in the baseline level of certain inflammatory biomarkers at~          3-months post-ablation period has any correlation with the long-term outcome in patients~          with atrial fibrillation~        4. To study the association of certain biomarkers with specific types of AF (paroxysmal or~          persistent or long standing persistent)~   "
184570|NCT01148862|"~     The purpose of this study is to assess the efficacy of the Low Glucose Suspend (LGS) feature~     in reducing hypoglycemia with the MiniMed Paradigm® X54 System with hypoglycemic induction~     from exercise.~      The study will consist of a total of 50 subjects, age 16 through 60 years with Type 1~     Diabetes Mellitus.~   "
184571|NCT01148849|"~     The purpose of this study is to determine if MGAH22 is safe when given by intravenous (IV)~     infusion to patients with HER2-positive cancer. The study will also evaluate how long MGAH22~     stays in the blood and how long it takes for it to leave the body, what is the highest dose~     that can safely be given, and whether it has an effect on tumors.~   "
184572|NCT01148836|"~     The purpose of this study is to evaluate the effects of Coenzyme Q-10, an antioxidant, in the~     treatment of pulmonary hypertension.~   "
184573|NCT01148823|"~     This randomized clinical trial was designed to assess the influence of time of dressing after~     breast reconstruction procedures on surgical site infections rates and skin colonization.~   "
184574|NCT01148810|"~     This study will determine the efficacy, safety, tolerability and the PK profile of BAF312, a~     novel immunomodulator, in polymyositis and dermatomyositis patients that are not responsive~     to traditional immunosuppressive and/or corticosteroid therapy. The study will consist of a~     12 week, randomized, placebo controlled period, followed by another 12 weeks where all~     subjects will receive BAF312 treatment.~   "
184575|NCT01148797|"~     A study designed to evaluate the role of treatment with a biological agent - Canakinumab in~     pediatric (age 4-20) Familial Mediterranean Fever (FMF) patients that are intolerant or~     resistant for colchicine treatment.~      The study hypothesis is that Canakinumab will reduce attack frequency and severity.~   "
184576|NCT01148784|"~     The purpose of this study is to compare two different soft tissue allografts, double bundle~     tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn~     anterior cruciate ligament (ACL) of the knee.~   "
184577|NCT01148771|"~     The purpose of this study is to characterize and compare the concentration-time profiles and~     multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily~     versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and~     pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and~     compared.~   "
184578|NCT01148758|"~     This exploratory, open label study will assess the the dose-effect relationship, efficacy and~     safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian~     cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg~     to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance~     imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable~     toxicity, patients may continue to receive their maximum dose of RO5323441 for a core~     treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the~     investigator's discretion until disease progression or unacceptable toxicity occurs. Target~     sample size is <100.~   "
184579|NCT01148745|"~     The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and~     ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as~     well as to determine the point at which serum ferritin and TSAT concentrations can be checked~     in iron deficiency anemia (IDA) hemodialysis patients.~   "
184580|NCT01148732|"~     Reliable endotracheal tube (ETT) insertion confirmation is essential for critically ill~     patients. Incorrect placement causes a high rate of mortality and morbidity. Therefore, early~     detection of accidental esophageal intubation must be a primary focus of emergency airway~     efforts in emergency department (ED). Although many techniques have been suggested to verify~     the ETT placement, there is currently no entirely reliable method. Ultrasonography (US) is an~     indispensable and easily accessible tool in ED. Several studies of ultrasonographic~     confirmation of ETT position provided promising results in cadaver model or patient in a~     controlled operating room setting.In this study, the investigators have proposed a protocol~     called T.R.U.E, an acronym for tracheal rapid ultrasound exam, to confirm the ETT position in~     emergency intubation. This method provided a fast, real-time examination to prevent~     esophageal or endotracheal intubation.~   "
184581|NCT01148719|"~     Background of the study:~      Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath~     (dyspnoea) which causes decreased mobility and restrictions in physical, psychological and~     social functioning. Patients commonly attribute this symptom to their age, and simply adjust~     their life style to it. Reduced exercise tolerance/dyspnoea is very common with prevalence~     rate of 20-60% of those aged 65 years and over. The main causus in the elderly are heart~     failure and chronic obstructive pulmonary disease (COPD). Both diseases have a high negative~     impact on the quality of life and are associated with frequent hospital admissions.~     Over-diagnosis, but more often under-diagnosis of heart failure and COPD is rather common in~     primary care. Establishing a diagnosis early in the course of the disease is useful because~     both diseases can be adequately and evidence-based treated. Therefore, an easy diagnostic~     triage-strategy followed bij direct treatment would be of great importance to asses and treat~     heart failure and COPD in elderly patient with shortness of breath.~      Objective of the study:~      Quantify how many frail elderly aged over 65 years with reduced exercise tolerance and/or~     exercise induced dyspnoea have previously unrecognised COPD and heart failure. Quantify the~     difference in prevalence of unrecognised COPD and heart failure between those who underwent~     the diagnostic triage compared to those who received care as usual. Quantify the effect of~     the diagnostic triage plus the additionally treatment changes on functionality and quality of~     life after 6 months compared to those who received care as usual. Quantify the~     cost-effectiveness of the diagnostic triage strategy compared to care as usual~      Study design:~      A clustered randomized diagnostic (follow-up) study~      Study population:~      First, pre-selection of patients aged over 65 years from 50 general practices is based on~     frailty. Frailty is based on the next criteria: use 5 or more different types of medical~     drugs chronically in the last year and/or have 3 or more chronic or vitality treating~     diseases (such as diabetes mellitus, COPD, heart failure, impaired vision). This will be done~     from the electronic medical files of the general practices. These elderly will receive the~     MRC questionnaire of dyspnoea and three additional questions related tot exercise~     intolerance. Those with any dyspnoea and/or reduced exercise tolerance will be invited to~     participate, except those with established heart failure and COPD.~      Study parameters/outcome of the study:~      Prevalence of latent heart failure and COPD. Difference in prevalence of latent heart failure~     and COPD between both groups.~      Differences in functionality and quality of life after 6 months between both groups.~     Cost-effectiveness and experienced patient burden of the diagnostic triage strategy.~   "
184582|NCT01148706|"~     To assist in guiding a rigid interventional instrument percutaneously, to a designated point~     within the body by means of CT visualization.~   "
184583|NCT01148693|"~     Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary~     strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding~     antibiotics to contrast media has proposed in some studies for prevention of cholangitis but~     remains controversial. In this study we compare effect of adding gentamicin versus placebo in~     preventing cholangitis in patients who undergone endoscopic stenting for non-calculus~     strictures and stenosis.~   "
184584|NCT01148680|"~     Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin~     therapy for 2 categories of patients: patients with unstable diabetes and patients who~     underwent kidney transplantation.~   "
184585|NCT01148667|"~     Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic~     dermatitis. In addition to balancing the gut microecology and promoting host immune defences,~     specific probiotics might further aid in controlling the microbial colonization of the skin,~     thereby reducing proneness to secondary infections which typically cause sustained symptoms.~      Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a~     double-blind design to receive extensively hydrolysed casein formula (NutramigenR,~     Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG~     (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu.~      Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of~     the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at~     each study visit (at entry and one month and three months thereafter).~   "
184586|NCT01148654|"~     Preterm birth (PTB) is a leading contributor to perinatal morbidity and mortality. While~     patients with preterm labor (PTL) are at an increased risk for PTB, not all PTL patients will~     deliver preterm. In patients with PTB, there is a high prevalence of 'intrauterine~     inflammation' as demonstrated by a large body of evidence. The presence of inflammation is~     noted by infiltration of inflammatory cells in the placenta and/or maternal fever in labor~     and/or elevation of cytokines in the amniotic fluid.~      Despite this significant association of inflammation with PTB, identification of women~     destined to deliver preterm by inflammatory markers in maternal blood has not been~     successful. To date, it has been difficult to determine which patients with PTL will~     experience PTB. Identification of biomarkers, such as high sensitivity C-Reactive Protein~     (hsCRP) as well as others such as sICAM, Pentraxin, sE-Selectin, and CxCL-10 in maternal~     serum and in placental cord blood, may help to serve three very important clinical aims. 1)~     Identification of novel biomarkers in maternal serum could help to distinguish those women~     with PTL who are most likely to deliver PTB. 2) These biomarkers may have a high negative~     predictive value and thus identify those women who are not likely to deliver preterm,~     avoiding undue hospital admission and medical therapies. 3) Select biomarkers in the mother~     and/or in cord blood may serve to identify those preterm neonates at greatest risk for~     adverse outcome. Through improved identification of these infants, studies with targeted~     therapies to reduce adverse neonatal outcomes in preterm neonates become feasible.~      This study involves a cohort assessment of women at risk for Preterm birth secondary to~     preterm labor, preterm premature rupture of membranes (PPROM), and cervical insufficiency~     (CI), between 22-0/7 and 33-6/7 weeks gestational age. We will obtain information regarding~     patients' pertinent past medical and obstetric history as well as small samples of maternal~     blood at up to four occasions, small samples of placental cord blood, a maternal saliva~     sample, and an infant buccal swab. We will follow each of these patient's pregnancy outcomes,~     and determine if there are any correlations between levels of certain biomarkers and latency~     to delivery as well as composite adverse neonatal outcomes. In women with PTB < 37 weeks,~     cord blood will be collected (as well as maternal saliva and an infant buccal swab) and~     biomarkers compared between those infants with and without specific adverse neonatal~     outcomes. Maternal saliva and buccal will be collected on all women and infants enrolled.~   "
184587|NCT01148641|"~     This study aims to assess the acceptability of lipid-based nutrient supplements (LNS) for use~     as nutritional supplements for infants and young children in Guatemala.~      The study was conducted in three phases. Phase 1 was a test-feeding to compare the~     acceptability of two different flavors of LNS (peanut and cinnamon) in infants and young~     children and their mothers or caregivers in terms of taste, smell and texture, as well as~     amount of the test-dose consumed. In Phase 2, children in the Phase 1 trial received a 2-week~     supply of one of the LNS products, which they consumed daily in their homes for 14 days under~     real-life conditions. Direct observation of supplement use and in-depth interviews with~     mothers, caregivers and health staff providing services in communities will be part of this~     phase too. In Phase 3, focus group discussions (FGD) were held with participants (mothers and~     caregivers) as well as with health staff providing services in communities to discuss~     different aspects of infant and child feeding and best ways for the LNS product to be used in~     the context of Guatemala.~      We hypothesized that both flavors of LNS would be accepted by Guatemalan infants and young~     children children and their mothers or caregivers.~   "
184588|NCT01148628|"~     This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the~     Maximum Tolerated Dose (MTD) and the Recommended Dose (RD) of the combination RAD001~     (escalating daily dose) and CaelyxTM (fixed dose) to patients with advanced solid tumors.~      Other purposes of the study are:~        1. define the safety profile of the combination after repeated administrations~        2. define hints of antitumor activity, to be confirmed in subsequent disease-oriented~          expansion phases at the RD.~        3. define the pharmacokinetic profile of the combination~   "
184589|NCT01148615|"~     Primary Objective:~        -  To confirm the dose of aflibercept in western studies by assessing the dose-limiting~          toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with~          docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors.~      Secondary Objectives:~        -  To assess the safety profile of intravenous (IV) aflibercept when administered in~          combination with docetaxel~        -  To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in~          combination~        -  To make a preliminary assessment of antitumor effects of the combination of docetaxel~          plus aflibercept in patients with evaluable disease~        -  To evaluate the immunogenicity of IV aflibercept~        -  To measure endogenous free Vascular Endothelial Growth Factor (VEGF)~   "
184590|NCT01148602|"~     To reduce door-to-needle times in acute stroke treatment. Using an organizational behaviour~     intervention (a large stopwatch), we will post a visual cue to remind all parties that time~     is brain. We hypothesize that this simple visual cue will improve door-to-CT scan times and~     door-to-needle treatment times, and thus improve treatment response, and reduce adverse~     events.~   "
184591|NCT01148576|"~     To investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in~     chronic hepatitis B patients.~   "
184592|NCT01148563|"~     The purpose of this research study is to see whether a tele-health intervention can improve~     health, functioning status, emotional status, quality of life, and patient satisfaction for~     patients with Congestive Heart Failure (CHF) and to examine the cost benefits of this~     intervention.~   "
184593|NCT01148550|"~     The specific aims of this study are (1) to determine the clinical phenotypes and natural~     history of hepatic RC and FAO disorders, (2) to determine the correlation between genotype~     and phenotype, (3) to determine if circulating biomarkers reflect diagnosis and predict liver~     disease progression and survival with the native liver, (4) to determine the clinical outcome~     of these disorders following liver transplantation, and (5) to develop a repository of serum,~     plasma, urine, tissue and DNA specimens that will be used in ancillary studies. To accomplish~     these aims, the ChiLDREN investigators at clinical sites (currently 15 sites) will~     prospectively collect defined data and specimens in a uniform fashion at fixed intervals in a~     relatively large number of subjects. Clinical information and DNA samples to be collected~     from subjects and their parents will enhance the potential for meaningful research in these~     disorders. A biobank of subject specimens and DNA samples will be established for use in~     ancillary studies to be performed in addition to this study.~   "
184595|NCT01148524|"~     This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence~     at 18 months after the vaccination course in study V72P10 (NCT00661713).~      Subjects who participated in study V72P10, and who meet all other enrollment criteria for~     this extension study, and a group of naïve subjects (defined as subjects who had never~     received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who~     were eligible to participate in this extension study, performed one study visit in which a~     single blood sample was drawn for MenB serological analyses.~   "
184596|NCT01148511|"~     The purpose of the study was to compare 2 treatment regimens for patients suffering from~     choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first~     treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and~     than re-treatment of patients who have a visual loss of more than 5 letters with monthly~     control (Treat and Observe). The second treatment regimen was 1 injection each month for 3~     months and than extending the control period if the macula is dry during the monthly control~     (Treat and Extend). If the Treat and Extend regimen is found effective and safe, the number~     of ranibizumab injections, the number of patient visits, the risk of adverse events due to~     the intravitreal injections, and policlinic occupation number could all be reduced.~   "
184597|NCT01148498|"~     The purpose of this trial is to compare the average change in the amount of amyloid beta~     species in blood after an infusion of solanezumab.~   "
184598|NCT01148485|"~     There are only very few data about the prevalence of CA-MRSA in France and no in athletes. In~     USA, the clone USA300 is widely disseminated and in Europe the clone ST80 predominates. The~     aim of the study was to study the carriage of S. aureus in athletes in a French county~     (Limousin) and to evaluate the proportion of CA-MRSA. The athletes will be met during their~     training, each one will fill-in a clinical information questionnaire. Nasal, throat, inguinal~     and skin lesions swab samples will be performed. The antibiotic susceptibility profile of the~     Staphyloccocus aureus strains isolated will be performed as well as the detection of the PVL~     gene. Strains will also be typed by different molecular methods (PGFE (Pulsed Gel Field~     Electrophoresis), SCCmec type (Staphylococcal Chromosome Cassette mec), and MLST (MultiLocus~     Sequence Typing)). The CIC (Clinical Investigation Center) of the Limoges University Hospital~     will be in charge of the inclusions of the athletes. The sample analysis will be centralized~     and performed at the Laboratory of Bacteriology of the Limoges University Hospital. A~     Clinical Research Officer of the Limoges University Hospital will be in charge of the survey~     of the study and will organize monthly meetings with all the participants of the study.~   "
184599|NCT01148472|"~     The primary objective of this study was to compare the efficacy of escitalopram with that of~     duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment.~     The study hypothesis was that there were clinically important differences between the two~     drugs in terms of efficacy and adverse event profiles.~   "
184600|NCT01148459|"~     The purpose of this study is to assess the safety and immunogenicity of the candidate malaria~     vaccine in HIV-infected infants and children~   "
184601|NCT01148446|"~     The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (>65~     years) with Diffuse Large B Cell Lymphoma (DLBCL).~   "
184602|NCT01148433|"~     The present non-interventional study is to document the testosterone levels in patients with~     clinical symptoms such as loss of sexual desire indicating hypogonadism (testosterone~     deficiency syndrome). During testosterone replacement therapy with TESTIM®, the changes in~     the quality of life - especially with respect to motivation, activity and fatigue - of~     hypogonadal patients will be documented and correlated with the testosterone levels during~     the course of therapy.~   "
184603|NCT01148420|"~     The purpose of this study is to investigate the effectiveness and acceptability of high dose~     MPA (20mg oral 3 times a day) for 3 days combined with an injection of DMPA 150 mg~     intramuscularly in the treatment of acute heavy, prolonged uterine bleeding who have been~     identified as being eligible for outpatient management~   "
184604|NCT01148407|"~     Blood samples on persons with cancer will be sampled for angiogenic, metastatic and~     coagulation proteins.~   "
184605|NCT01148394|"~     Introduction: Multimodal rehabilitation (MMR), combines various elements in the management of~     the surgical patient which lead to a decrease in surgical stress and a more comfortable and~     faster postoperative recovery.~      Objective: To assess the introduction of MMR in a specialized Colorectal Unit and compare the~     results with the traditional model assessing its´ efficacy as to recovery, and reduction of~     hospital stay and costs.~   "
184606|NCT01148381|"~     The influence of genes on addictive and neuropsychiatric disorders is complex, especially~     given that multiple genes likely influence certain behaviors that are correlated with~     addiction. Researchers are interested in looking at the genetic information of individuals~     who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic~     variants that may be related to substance abuse. Researchers will study the effects of genes~     on several aspects of thinking such as attention, memory, decision making, problem solving,~     learning, and emotional feelings, and investigate the ways in which genetic information~     affects addictive behaviors and substance abuse. In addition, researchers will study how~     genes may explain differences in imaging data in substance users.~      Objectives:~      - To collect genetic information for research on genetic aspects of addiction and substance~     abuse.~      Eligibility:~        -  Adults age 18 or older~             -  (1) healthy, non-drug-using nonsmokers,~             -  (2) healthy smokers,~             -  (3) healthy individuals dependent on other commonly abused drugs, and~             -  (4) individuals with other psychiatric disorders.~        -  Participants must be right-handed, and must be enrolled in another National Institute on~          Drug Abuse, Intramural Research Program imaging protocol.~      Design:~        -  This study involves one to two visits to National Institute on Drug Abuse, Intramural~          Research Program that may be separate from the participant s current research protocol~          study visits or on the same day as those visits. .~        -  Participants will provide a blood sample and complete questionnaires about mood, memory,~          and learning.~        -  Participants may also be asked to do a few tasks, such as playing computer games~          involving coin tosses and money management, or responding to questions on a computer~          screen.~   "
184607|NCT01148368|"~     The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and~     the safety of fimasartan in renal impairment patients and healthy volunteers.~   "
184616|NCT01148238|"~     Autoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent~     Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of~     T-reg cells is an important cause of autoimmunity. The study hypothesis are:~        1. Patients with newly found diabetes type 1 have less T-reg than healthy.~        2. Patients with newly found diabetes type 1 have less T-reg than patients with long~          duration of the illness.~        3. The number of T-reg is negative associated with HLA-risk-haplotype.~        4. The number of T-reg is negative associated with LADA.~        5. Differences relating to inflammatory cytokines will be seen among patients with newly~          found diabetes type 1, but not among others.~   "
184608|NCT01148355|"~     Background:~        -  Multiple social, psychological, and environmental factors contribute to adolescents' use~          of cigarettes. Environmental smoking cues have been shown to play an important role in~          the maintenance of nicotine addiction and in relapse to smoking. However, few studies~          have examined craving and cue-reactivity in adolescent smokers, even though craving~          appears to contribute to ongoing smoking and relapse in this age group.~        -  Another factor central to addiction is the rewarding effect of drugs, or the interaction~          between the person, the drug, and the environmental setting. However, more research is~          needed on whether environmental cues lead to increased smoking in adolescents.~      Objectives:~      - To determine the effects of smoking versus neutral cues in adolescents who smoke on (1)~     craving, mood, and autonomic responsivity and (2) the relative reinforcing efficacy of~     tobacco cigarettes.~      Eligibility:~      - Adolescents 12 to 17 years of age who are current smokers (at least five cigarettes per day~     for the past 6 months).~      Design:~        -  This study will involve three study visits. Participants will be allowed to smoke before~          all study sessions and will give a breath carbon monoxide (CO) sample before all~          sessions. Participants must not use any illicit drugs or alcohol 24 hours before~          sessions.~        -  Visit 1 (baseline session): Participants will provide a urine sample and will be~          familiarized with the study room and session design.~        -  Visits 2 and 3: Participants will be connected to physiological recording devices to~          measure heart rate, perspiration, and other physical responses. After baseline readings,~          participants will be exposed to smoking cues at one experimental session and to neutral~          cues at the other experimental session.~        -  Before, during, and after cue presentation, participants will complete self-report~          measures of mood and craving and have physiological measures taken. They will then be~          re-exposed to smoking or neutral cues and engage in a self-administration procedure to~          examine the effect of cues on the reinforcing efficacy of cigarettes.~   "
184609|NCT01148342|"~     Background:~        -  3,4-Methylenedioxymethamphetamine (MDMA), commonly known as ecstasy, is a synthetic~          psychoactive drug that has shown a steep increase in recreational use and abuse by young~          people in recent years. Research studies have reported that chronic MDMA users who also~          consume other legal and illegal substance show memory deficits; however, because of the~          combination of drugs often involved, it is difficult to determine MDMA s contribution to~          these effects.~        -  Only a few studies have examined the immediate physical and behavioral effects of MDMA~          given at dose levels commonly used in young adults. Researchers are interested in using~          functional magnetic resonance imaging (fMRI) to examine changes in brain activity and~          function in MDMA users compared with users of other drugs and non-drug-using~          individuals.~      Objectives:~      - To evaluate the effects of MDMA on thinking and brain function.~      Eligibility:~      - Individuals between 18 and 30 years of age who are (1) current users of MDMA (2), current~     drug users who do not use MDMA, or (3) healthy non-drug-using volunteers.~      Design:~        -  Participants will complete one training session and three scanning sessions.~        -  Before the start of the study, participants will complete questionnaires about medical~          and psychological history, and provide information about past or current drug use.~          Researchers will introduce the tasks to be performed during the scanning session(s), and~          will allow participants to practice the tests.~        -  Participants will provide urine, saliva, and hair samples for testing before the start~          of the study, and multiple times during each scanning session.~        -  Participants who use MDMA and participants who use other drugs will stay overnight at~          the clinical center prior to each scanning session. Participants who do not use drugs~          can spend the night prior to scanning or arrive at the clinical center on the morning of~          the scanning session.~        -  Participants who use MDMA will receive either MDMA or a placebo during the scanning~          sessions, and will not be told which one they have received. Because of the nature of~          MDMA, participants will be required to stay at the clinical center until the effects of~          the drug have worn off, and will be required to return to the clinical center on the~          following day for a follow-up examination.~        -  During the study, participants will be asked to do one or more tasks selected by the~          researchers. The tasks will be performed on a computer in an MRI machine, and may~          involve receiving monetary rewards for actions, memory and reaction-time tests, or other~          tests that involve responding to instructions on the screen.~   "
184610|NCT01148329|"~     The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-~     Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™~     Element™ Coronary Stent System in unselected patients in routine clinical practice.~   "
184611|NCT01148316|"~     Obsessive-compulsive disorder affects approximately 2% of the population, frequently has its~     onset during childhood or adolescence and is potentially incapacitating. If not properly~     treated, this disorder tends to follow a chronic course. Pharmacotherapy with clomipramine~     and selective serotonin reuptake inhibitors (SSRIs), such as fluvoxamine, fluoxetine and~     sertraline, has been approved for pediatric OCD. However, up to 30% of patients may not~     benefit from these treatments, and the presence of residual symptoms is frequent among~     treatment responders. Cognitive-behavioral therapy (CBT) is also recognized as first line~     treatment for pediatric OCD, either administered in individual or group format. There is~     evidence suggesting equivalent efficacy for SSRIs and CBT in pediatric OCD, but there is no~     data on adaptive treatment strategies regarding such treatments on the long term outcome of~     OCD patients. The aim of this study is to verify, in a randomized design, if there is an~     optimal sequential treatment strategy for pediatric OCD, adopting the two most studied~     treatments for this disorder: an SSRI and group CBT (GCBT). The investigators hypotheses are:~     (1) both types of treatment will present similar efficacy in the short term (14 weeks); (2)~     for non-responders to the first type of treatment (fluoxetine up to 80mg/day or GCBT for 14~     weeks), combined treatment (fluoxetine + GCBT for another 14 weeks) will be more effective~     than switching treatment modality (from fluoxetine to GCBT or from GCBT to fluoxetine for~     additional 14 weeks) after additional 14 weeks.~   "
184612|NCT01148303|"~     The investigators intend to study whether the use of the pain medication etoricoxib (Arcoxia)~     taken just before the Ramadan fast will prevent or lessen headache that some people get while~     fasting. The investigators hypothesize that etoricoxib will reduce the number of people~     getting headache, more than placebo. The investigators will do this by giving participants in~     the study either real medication or placebo (sugar pill) and comparing the results. The~     investigators will study this over two weeks. The first week one group will get the medicine~     and the other the placebo. The second the groups will switch. Neither the subjects nor the~     investigators will know who is in which group.~   "
184613|NCT01148290|"~     The surgical treatment of vulvar cancer is characterized by a radical approach as standard,~     often associated to an important rate of functional complications. This surgery often~     includes the partial excision of urethra, resulting in a reduction of urethral closure~     pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral~     mobility. As consequence women treated for vulvar cancer may develop urinary incontinence.~     The incidence of this complication has been differently reported, but seems to reach the~     100%. Poor data are available regarding the treatment of post vulvectomy urinary incontinence~     and no clear indication may be given at regards.~      Based on these considerations the aim of this trial will be to compare tension free vaginal~     tape and bulking agent injection in women with urinary stress incontinence developed after~     radical surgery for vulvar cancer.~   "
184614|NCT01148277|"~     This is a prospective, randomized-controlled trial (RCT) comparing the use of Propofol and~     Remifentanyl and traditional sedation (Midazolam and Fentanyl) for diagnostic colonoscopies~     in patients with compensated cirrhosis child A-B. The working hypothesis is that the use of~     propofol will be translated in a shorter recovery and discharge times with a higher patient~     satisfaction and a decrease in general complications (Hepatic Encephalopathy) in the context~     of patients with advanced liver disease.~   "
184615|NCT01148264|"~     This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment~     of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and~     aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified~     MASCC questionaire with a visual analog scale.~   "
184617|NCT01148225|"~     There is an unmet medical need in non-infectious intermediate-, posterior- and pan uveitis.~     These types of uveitis are at a higher risk for vision loss compared to anterior uveitis.~     Patients with these types of uveitis are often treated with chronic corticosteroids. The use~     of chronic corticosteroids is linked with predictable long-term side effects. The objective~     of this study is to evaluate the long term efficacy and safety of adalimumab subjects with~     non-infectious intermediate-, posterior- or pan-uveitis.~   "
184618|NCT01148212|"~     Testing safety and tolerability of transcranial direct current stimulation (2 mA, 20 minutes)~     in four different protocols:~      saline-soaked sponges electrode with electrode gel tap-water-soaked sponges~     tap-water-soaked-sponges + sham stimulation~      Outcome measures are tolerability (comfort rating questionnaire), impedances, skin elasticity~   "
184619|NCT01148199|"~     Biliary complications are one of the most common problems after orthotopic liver~     transplantation (OLT),occurring in up to 24% of patients.~      Anastomotic strictures have been endoscopically managed with plastic stents placement.~     Recently, partially and fully covered metal stents have been alternatively used to treat~     refractory benign biliary stenosis. The investigators purpose is to compare efficacy and~     safety of metallic stents versus multiple plastic stents in the endoscopic management of post~     transplant biliary complications.~   "
184620|NCT01148186|"~     An educational intervention targeting community-dwelling older adults will lead to a~     reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin).~      Cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will~     lead to improved cognitive outcomes in older adults.~   "
184621|NCT01148173|"~     Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating~     complication. There is no therapy standard, conventional approaches are palliative. This~     study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose~     chemotherapy and autologous stem cell transplantation as a potentially curative approach.~   "
184622|NCT01148160|"~     Multiple factors are associated with a large variability in voriconazole exposure following~     standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug~     interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes.~      Voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by~     CYP2C19. The polymorphisms account for a relatively large portion of inter-individual~     variance observed in voriconazole plasma concentrations.~      However, there are limited data on the relationships between voriconazole blood levels and~     clinical outcomes or safety in Asian populations.~      The purpose of this study is to investigate the relationships of voriconazole blood levels~     with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with~     invasive pulmonary aspergillosis.~   "
184623|NCT01148147|"~     Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of~     adenosin in elective patients undergoing coronary angioplasty.~   "
184624|NCT01148134|"~     This study is characterizing the pharmacokinetics of vincristine using two different cohorts~     of patients. The first cohort includes patients with acute lymphoblastic leukemia (ALL) that~     are Bcr-Abl positive. This cohort of patients will receive vincristine along with imatinib in~     the induction chemotherapy regimen. The second cohort includes patients with ALL that are~     Bcr-Abl negative. This cohort of patients will receive vincristine without imatinib in the~     induction chemotherapy regimen. This study involves blood draws beginning on day 7 of the~     treatment protocol and these samples will be analyzed for pharmacokinetic parameters.~      Imatinib and vincristine are both metabolized by the hepatic CYP 450 enzyme system. Imatinib~     is an inhibitor of the system and co-administration of imatinib and vincristine has the~     potential to increase the blood level of vincristine. This could explain the increased level~     of neurotoxicity that is currently being seen with the co-administration of these two agents~     in the treatment of Bcr-Abl positive ALL.~   "
184625|NCT01148121|"~     This study may provide information that may serve as the foundation for a larger research~     study to address issues regarding the causes, diagnosis, and treatment of osteoporosis in the~     Down syndrome patient population.~   "
184626|NCT01148108|"~     This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in~     relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple~     myeloma. The study will be conducted in two stages with 5-6 patients in each indication in~     Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.~   "
184627|NCT01148095|"~     AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is~     split in to two parts. Part A will measure the effect of food and a new formulation of the~     drug in the blood and see how well it is tolerated. Part B will commence after the completion~     of Part A and will investigate the safety and tolerability of daily dosing with AZD2516.~   "
184628|NCT01148082|"~     The purpose of this research is to investigate school response to families who have children~     with cancer. It is anticipated that the results of this study will enhance the support that~     schools can give to the population of families who have a child with cancer. The study will~     involve the parents in these families, the principal and an educator in the school of the~     child with cancer. Measurement tools will include surveys, interviews, and other relevant~     educational and medical documents.~   "
184629|NCT01148069|"~     Standard treatment of locally-advanced prostate cancers consists in the association of~     radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years.~     This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension~     to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph~     node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of~     bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In~     the aim of lowering the toxicity, the treatment in this study will associate:~        -  pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the~          radiation target volume to the prostate only (and not to irradiate the SV);~        -  a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy~          (IMRT) and Image-Guided Radiation Therapy (IGRT).~   "
184658|NCT01147692|"~     This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with~     albiglutide in healthy adult subjects. The primary objective is to assess the effect of~     albiglutide doses on the pharmacokinetics of simvastatin.~   "
184630|NCT01148056|"~     This study will investigate short course radiation therapy using IMRT as an alternative to~     standard chemo radiation because prior studies have shown that this method of treatment will~     potentially reduce some fo the side effects of standard treatment, improve quality of life,~     and help to control the growth of rectal cancer cells. IMRT is a type of radiation that uses~     computer-generated images to match radiation to the size and shape of the tumor. Since the~     intensity of each radiation beam can be controlled, the radiation dose can wrap around normal~     tissue which allows the study doctor to deliver a higher dose of radiation to the tumor with~     less damage to nearby healthy tissue. The purpose of this research study is to see what~     impact this treatment will have on quality of life, as well as to see if there are any late~     side effects that come about after the participant has completed the treatment.~   "
184631|NCT01148043|"~     The purpose of this study is to determine the efficacy of hydroxychloroquine in hand~     osteoarthritis.~   "
184632|NCT01148030|"~     Patients presenting in the Emergency Department or admitted to the hospital with displaced~     hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal~     instability/fractures in need of urgent surgical intervention will receive treatment to~     reduce the number of microorganisms in their nose prior to surgery. After surgery, the~     subjects will be observed for any surgical site infections.~   "
184633|NCT01148017|"~     The primary objective was to evaluate the persistence of bactericidal antibodies in children~     40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received~     Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have~     never received any meningococcal vaccine (naïve subjects) to serve as a control group. In~     addition, the response of a booster dose at 60 months was evaluated.~   "
184634|NCT01148004|"~     Background:~      - Patients infected with the human immunodeficiency virus (HIV) are often treated with~     protease inhibitors that help fight HIV infection. However, these medications often increase~     blood cholesterol levels, particularly triglycerides and low-density lipoproteins, and can~     lead to heart disease and other problems. Patients may take drugs known as fibrates (such as~     gemfibrozil (Lopid )) to lower triglyceride levels, but even with maximum approved doses~     patients often cannot reach goal triglyceride levels. Research suggests that fibrates and~     certain HIV medications, such as ritonavir and lopinavir/ritonavir, may interact and decrease~     the effectiveness of the fibrate treatment. More research is needed to determine the best~     drug to lower triglyceride levels in HIV patients who are receiving protease inhibitor~     therapy.~      Objectives:~      - To evaluate the drug-drug interaction between fenofibrate and protease inhibitors~     lopinavir/ritonavir and ritonavir.~      Eligibility:~      - Healthy individuals between 18 and 60 years of age.~      Design:~        -  This study will require a screening visit and 18 study visits. The screening visit will~          take 3 to 4 hours, and can occur 7 to 30 days before starting the study. The rest of the~          study, not including the screening visit, is 48 days. Three of the visits will take~          about 12 hours, and the remaining 15 visits will take about 1 hour.~        -  For study days 1 to 7, participants will take fenofibrate alone. Participants will keep~          a daily record of medication doses and any side effects.~        -  For study days 8 to 27, participants will take fenofibrate and ritonavir. Participants~          will keep a daily record of medication doses and any side effects.~        -  For study days 29 to 48, participants will take fenofibrate and lopinavir/ritonavir.~          Participants will keep a daily record of medication doses and any side effects.~        -  Participants will have regular study visits to provide blood samples for research and~          monitoring....~   "
184635|NCT01147991|"~     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective~     immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with Epstein-Barr virus and cancer.~   "
184636|NCT01147978|"~     The investigators propose an interventional multicentric (23 ICUs) study measuring the impact~     of a consultation at the end of ICU stay for the patients and his/her families on the~     prevalence of symptoms of PTSD and anxiety or depression 3 months and one year after~     discharge. Patients will be randomly assigned to a intervention or control group. In the~     intervention group, the patient and his/her family will benefit from an conference by the~     intensivist at the end of the ICU stay, regarding information about the progress of his stay~     in ICU, his orientation after discharge, the possibility of consulting a GP, etc. Patients~     and proxies will be interviewed by phone three months and one year after discharge from ICU.~     Main instruments are Hospital Anxiety and Depression Scale, and Impact of Events Scale~     Revised.~   "
184637|NCT01147965|"~     The purpose of this study is to find out what effects (good and bad) that a cancer vaccine~     has on you and your cancer. The cancer vaccine is called Ad5 [E1-, E2b-]-CEA(6D)or ETBX-011~     and is made by Etubics. This vaccine is based on a virus called an adenovirus but it has been~     changed to express the protein CEA that is found on some cancer cells. Therefore, the vaccine~     can tell the immune system to attack cancer cells which make CEA. The investigators are~     trying to determine whether giving this virus is safe and whether this causes a strong immune~     system attack on the cancer. ETBX-011 is an investigational drug.~   "
184638|NCT01147952|"~     Regular exercise is known to produce significant health benefits and to reduce the risk of~     heart diseases, although how this benefit occurs is not well understood. White blood cells~     are known to be involved in triggering heart attacks, and which genes are switched on or off~     in white blood cells determines whether they have beneficial or harmful effects. Previous~     studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood~     gene expression (which reflects white blood cell gene expression) is able to distinguish~     between patients with and without coronary artery disease, or patients who are able to~     develop good compared with poor coronary collateral arteries. Therefore, the gene expression~     signature in peripheral blood may provide novel diagnostic or prognostic information, and~     insight into the pathogenesis of heart disease.~      We therefore hypothesise that exercise alters peripheral blood gene expression in patients~     with coronary artery disease and angina. This will identify possible ways that exercise~     improves angina and reduces the risk of heart disease.~   "
184639|NCT01147939|"~     The purpose of the study is to assess the efficacy and safety of elacytarabine versus~     investigator's choice treatment in patients with relapsed or refractory acute myeloid~     leukemia (AML).~   "
184640|NCT01147926|"~     This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase~     III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment~     in male subjects with chronic constipation.~      Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of~     prucalopride will be assessed.~   "
184641|NCT01147913|"~     This study will examine how well a novel four-session computerized program, designed to help~     adolescents learn to interpret ambiguous situations less negatively, reduces symptoms of~     depression and decreases negative information-processing biases.~   "
184674|NCT01147484|"~     The purpose of this study is to find out what effects this new drug foretinib has on this~     type of breast cancer, called triple negative breast cancer because the cancer tissue is~     estrogen, progesterone and HER2 receptor negative.~   "
184642|NCT01147900|"~     The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a~     dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa~     in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to~     participate in this study.This protocol posting deals with objectives & outcome measures of~     the booster phase. The objectives & outcome measures of the primary phase are presented in a~     separate study (see reference).~   "
184643|NCT01147887|"~     The purpose of this study is to evaluate the effect of 26489112 on the pharmacokinetics~     (blood levels) of a combination of 3 drugs administered to healthy volunteers.~   "
184644|NCT01147874|"~     This is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects~     with psoriasis looking for the prevalence of psoriatic arthritis. Subjects will be seen and~     evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. A subset of~     subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).~   "
184645|NCT01147861|"~     The aim of this study is to verify whether a significant decrease in glucose levels can be~     achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels~     and a placebo will be evaluated in a three period crossover study with two active doses and~     one placebo dose per subject, in order to determine whether there is a dose that produces~     glucose lowering in the target population. In addition, this study will investigate the~     optimal dosing regimen for full manifestation of any metabolic effect of GSK256073 by~     comparing once a day versus twice a day regimens.~   "
184646|NCT01147848|"~     The purpose of the study is to compare the efficacy and safety of fluticasone~     furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone~     propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of~     age and older with persistent bronchial asthma over a 24-week period.~   "
184647|NCT01147835|"~     Young children with asthma who use drugs for their asthma are at higher risk for tooth decay.~     These drugs can cause (1) dry mouth from less saliva secretion and (2) acid mouth that causes~     teeth to become soft and bacteria to multiply. Herbal lollipops may reduce the risks of tooth~     decay in young children. The purpose of this research is to determine how well herbal~     lollipops can improve the negative effects of asthma drugs over a 6-month period. Herbal~     lollipops contain Chinese licorice root.~   "
184648|NCT01147822|"~     This study is being conducted to provide a direct comparison of the efficacy, safety, and~     tolerabilityfor pazopanib and sunitinib (SUTENT) in the Asian population.~   "
184649|NCT01147809|"~     The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort,~     dose finding study to assess the safety and efficacy of eltrombopag in patients with solid~     tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin~     or cisplatin. Phase I of the study will examine safety and tolerability of various doses of~     eltrombopag to identify a dose and schedule of eltrombopag. Phase II will confirm that the~     chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful~     benefit(s) to thrombocytopenic patients by improving platelet numbers.~   "
184650|NCT01147796|"~     Transoesophageal echocardiography (TEE) is considered as the gold standard method for~     detection of left atrial appendage (LAA) thrombus but is a semi-invasive investigation. The~     primary aim of the study is to evaluate the accuracy of the 64 slices CT using prospective~     gating for the diagnosis LAA thrombus. The secondary objective is to defined the optimal~     acquisition time offering the best diagnostic performance (early, late or both).~   "
184651|NCT01147783|"~     The aim of the present study is to compare radiographic upper airway measurements of the~     SimBabyTM pediatric patient high-fidelity simulator with actual human airway anatomy to~     assess the grade of realism of the simulator.~   "
184652|NCT01147770|"~     The objective of this study is to evaluate the effect of the prolongation of luteal support~     on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist~     cycles.~   "
184653|NCT01147757|"~     Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic~     consumption in pediatric laparoscopic ureteroneocystostomy.~   "
184654|NCT01147744|"~     To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form~     (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in~     adolescent and adult subjects (12 years of age and older) with persistent asthma. These data~     will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried~     forward in Phase III asthma studies. The study also includes Fluticasone Propionate~     Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an~     exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid~     and a leukotriene receptor antagonist.~   "
184655|NCT01147731|"~     This open-label study evaluates the pharmacokinetics of warfarin when coadministered with~     albiglutide in healthy adult subjects. The primary objective is to assess the effect of~     albiglutide doses on the pharmacokinetics of warfarin.~   "
184656|NCT01147718|"~     This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of~     digoxin when coadministered with albiglutide in healthy adult subjects.~   "
184657|NCT01147705|"~     Peripheral arterial disease (PAD) is a common condition that arises due to the build up of~     atheroma in the arteries supplying blood to the peripheral muscles and other tissues. This~     imbalance between oxygen supply and demand becomes particularly apparent when patients with~     the condition are walking. The pain and weakness they experience (mainly in the calf but less~     commonly in the thigh) is known as intermittent claudication and resolves upon cessation of~     exercise.~      It is an important disease to study as it is (i) common (est. prevalence of symptomatic~     intermittent claudication in Scotland of 4.5%) and (ii) those with it have a 1.6 times higher~     relative risk of ischaemic heart disease. These patients also have a significantly higher~     mortality than age-matched controls at around 12% per year.~      There are two main aims of therapy - (i) to reduce the risk of cardiovascular events by way~     of standard secondary prevention measures (smoking cessation, anti-platelet,~     anti-hypertensive and cholesterol-lowering therapy, diabetic control) and (ii) to treat~     symptoms.~      Supervised exercise therapy has been shown to be beneficial in improving walking time and~     distance in selected patients with leg pain from intermittent claudication with an overall~     increase in walking distance of approximately 150 metres at three months.~      There are numerous drug treatments available for consideration in PAD patients (mainly~     cilostazol in the UK), but many of these have either undesirable side effects or no clear~     evidence of benefit. The range of increase in walking distance on cilostazol was reported to~     be a 50-76% increase over three months compared to 20% with placebo with some significant~     improvements in Quality of Life (QOL) indicators, although with a significant number of~     adverse effects (16% vs 8% on placebo) limiting therapy. The current cost (March 2010) is~     £35.31/month.~      Other options for therapy include angioplasty and bypass surgery. At present these are only~     recommended for patients who fail to respond to medical therapy and have severely disabling~     symptoms (in the absence of significant exercise-limiting comorbidities).~   "
184659|NCT01147679|"~     This study is designed to document the loss of sociomoral emotions (like empathy, guilt, and~     embarrassment) in patients with behavioral variant frontotemporal dementia. The loss of these~     emotions, which function as the motivators for social behavior, will manifest in specific~     interpersonal behaviors. These behaviors will correlate with regional changes in regional~     changes in medial frontal and anterior temporal lobes. These social and emotional changes~     will be compared with a young-onset Alzheimer's disease comparison group.~   "
184660|NCT01147666|"~     The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining~     and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease(ESRD)on~     maintenance hemodialysis~   "
184661|NCT01147653|"~     The purpose of this study is to determine the efficacy of a single intravenous infusion of~     autologous umbilical cord blood (UCB) for the treatment of pediatric patients with spastic~     cerebral palsy.~   "
184662|NCT01147640|"~     A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam~     (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000~     mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose~     adjustments for subjects with mild renal impairment are not necessary and subjects with more~     severe degrees of renal failure are excluded.~   "
184663|NCT01147627|"~     The purpose of this study is to investigate and evaluate the effects of different~     interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell~     function in newly diagnosed drug-naïve type 2 diabetic patients.~   "
184664|NCT01147614|"~     The purpose of this study is to determine whether a brief (12 week) psychological treatment~     program, based in primary care, can help youths struggling with anxiety and/or depression.~     This brief cognitive behavioral therapy program will be compared to enhanced referral to~     specialty mental health care.~   "
184665|NCT01147601|"~     The purpose of this study is to learn about a new potential use for topical timolol 0.5%~     aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study~     would examine whether topical timolol could be a potential therapy.~   "
184666|NCT01147588|"~     The aim of this study is to determine if there is a pharmacological interaction between~     clopidogrel and different types of proton pump inhibitors (PPIs), and if the extent of this~     possible interaction would change over time.~   "
184667|NCT01147575|"~     Creatine supplementation in RTT: a randomized controlled trial~      Rett Syndrome (RTT) is a neurodevelopmental disorder characterised by apparently normal early~     development (stage 1 of RTT) followed by loss of purposeful hand use, distinctive hand~     stereotypes, slow brain growth, loss of language, respiratory irregularities,~     gastrointestinal disturbances, gait abnormalities, seizures, and mental retardation. These~     symptoms typically appear between 6 and 18 months of age (stage 2). Subsequently, there is~     gradual stabilisation of severe mental retardation and motor compromise (stage 3). The~     majority (70% to 80%) of patients show mutations in the methyl-CpG-binding-protein-2 (MeCP2)~     gene, located on chromosome Xq28. MeCP2 encodes a transcription repressor protein that is~     ubiquitously expressed in all tissues.~      As RTT primarily affects females, only very few males with mutations in MeCP2 have been~     identified. Mutations in MeCP2 have also been identified in children with X-linked mental~     retardation, autism and a clinical phenotype that resembles Angelman Syndrome.~      The aim of this study is to investigate the effects of a dietary supplement on the~     biochemical and clinical parameter of RTT. About 80 % of labile methyl groups generated~     through the re-methylation cycle are used for the synthesis of creatine within the human~     organism. Supplementation of creatine will therefore increase the availability of labile~     methyl groups for different methylation reactions including methylation of DNA.~      The study will be double blind and cross-over. The patients will get creatine monophosphate~     (200 mg/kg/d in three dosages per day) or placebo. After 6 months and a wash-out period of 4~     weeks the groups are changed for the next 6 months.~      All participants with RTT and mutations in MeCP2 will undergo physical and neurological exam,~     quantitative EEG, behavioral assessment, laboratory testing, and neuropsychological~     evaluations. Participants will have a follow-up after 3, 6, 10, 13 and 16 months (3 months~     after finishing the study), which will include similar assessments.~   "
184668|NCT01147562|"~     Lung cancer is responsible for the most deaths due to cancer each year in both men and women~     worldwide and once diagnosed, the 10 year survival rate is poor (<15%). This poor prognosis~     is based in large part on the absence of an effective diagnostic test for the disease. The~     chief objective of this study is to develop a molecular-based diagnostic test specific for~     lung cancer. Subjects suspected or diagnosed with lung cancers, who are either undergoing~     thoracentesis, biopsy of a suspicious lesion or surgical resection of their tumor will be~     asked to participate in this study. Those subjects, who will undergo surgical resection, will~     donate both lung tumor tissue and adjacent normal lung tissue (potentially including lymph~     nodes), while non-surgical candidates will donate a portion of their excess biopsy sample, if~     available, after diagnosis has been confirmed. Subjects undergoing thoracentesis for pleural~     effusion will donate a portion of their fluid sample, if the fluid volume collected is in~     excess of that needed for clinical care purposes. Blood samples and optionally saliva will~     also be collected from all subjects, whether undergoing surgery or not. In addition to~     biosample collection, detailed annotated demographic and clinical information will be~     collected from subjects. Subjects will be followed for outcome analysis, specifically for~     tumor recurrence, every 6 months, during 5 years. In case of change in chemotherapy~     treatment, biosamples and clinical information will also be collected. Collected biosamples~     will be analyzed using a series of molecular and proteomic technologies for developing~     biomarkers of the disease.~   "
184669|NCT01147549|"~     The purpose of the study is to characterise the absorption, distribution, metabolism and~     excretion (ADME) of a single oral dose of [14C]AZD9668.~   "
184670|NCT01147536|"~     Renal cell carcinoma patients' blood will be monitored over a period of 15 weeks to evaluate~     their level of immune response to multiple administration of HSPPC-96.~   "
184671|NCT01147523|"~     The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E~     on serum levels of adipokines 52 weeks post-treatment.~   "
184672|NCT01147510|"~     To compare the efficacy of combination therapy of montelukast plus low dose inhaled~     budesonide and single therapy of medium dose inhaled budesonide on asthma control such as~     inflammatory markers and clinical indicators and to compare treatment response according to~     leukotriene related genotypes in elderly patients with asthma~   "
184673|NCT01147497|"~     Because of misoprostol's known ability to cause cervical dilation, some family planning~     providers give their patients a dose of this drug prior to insertion. The goal of this study~     is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases~     insertion and decreases pain.~   "
184675|NCT01147471|"~     The purpose of this study is to determine whether operative fixation of unilateral flail~     chest provides greater benefit than non-operative treatment.~   "
184676|NCT01147458|"~     PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which~     is involved in the pathway that causes inflammation and pain. The purpose of this study is to~     test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the~     knee by itself or with naproxen, particularly to test if patients have less pain.~   "
184677|NCT01147445|"~     The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli~     infection) is safe. This vaccine will be tested to see what effects it has on the body and~     the ability of the vaccine to help the body resist disease. Researchers want to find the~     highest dose of dmLT vaccine that can be given without causing severe side effects. Most E.~     coli bacteria are harmless to humans and can even be beneficial. However, some are harmful,~     and can cause diarrhea. About 32 healthy adults, ages 18-45, will participate in this study.~     This study will require volunteers to stay in the research facility for several nights.~     Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures~     include: stool samples, blood samples, and documenting side effects. Participants will be~     involved in study related procedures for about 8 months.~   "
184678|NCT01147432|"~     Prior to administering PF-04427429 to patients we wish to increase the understanding of~     functional effects associated with calcitonin gene related peptide (CGRP) pathways. This~     study will examine whether it is possible for a single dose of PF-04427429 to acutely~     attenuate a capsaicin induced flare response.~   "
184679|NCT01147419|"~     Different strategies exist in the treatment of chronic long occlusion of the superficial~     femoral artery. Traditionally, these patients should be treated with bypass. If the great~     saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the~     skill of endovascular treatment is developing rapidly, and lots of doctors think most of such~     patients could be treated with stent. The purpose of this trial is to compare stent and~     artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral~     artery. The study hypothesis is that patency rates are comparable and therefore the minimal~     invasive treatment of stent can be considered in such patients.~   "
184680|NCT01147406|"~     The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy~     subjects.~   "
184681|NCT01147393|"~     A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab~     (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability~     to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose~     to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also~     found active in Phase I/II trials.~      The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used~     in combination with veltuzumab. The primary objective is to determine the response rate of~     this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and~     targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also~     be monitored at various times.~   "
184682|NCT01147380|"~     The objective of this study is to evaluate feasibility and safety of the adoptive transfer of~     activated natural killer (NK) cells extracted from cadaveric donor liver graft perfusate for~     liver transplant recipients with hepatocellular carcinoma (HCC)~   "
184683|NCT01147367|"~     The purpose of the study is to examine the benefits of physical activity for breast cancer~     survivors related to muscle strength, tiredness, and sleep quality. Also, the study will~     determine the potential role of inflammation in these benefits.~   "
184684|NCT01147354|"~     The aim of this study is to evaluate the effect of selenium supplementation on oxidative,~     inflammatory and nutritional markers in hemodialysis patients.~   "
184685|NCT01147341|"~     Purpose of the study is to determine if Cimzia is safe and effective in subjects who have~     received previous treatment with a TNF-alpha inhibitor other than Cimzia.~   "
184686|NCT01147328|"~     The purpose of this study is to assess usage of the virtual health record (VHR), and~     determine the effects of this technology on healthcare utilization.~   "
184687|NCT01147315|"~     The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.~   "
184688|NCT01147302|"~     The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1~     Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated~     Rejection (AMR).~   "
184689|NCT01147289|"~     A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and~     safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in~     lumbar sciatic pain. The study will enroll 140 patients in each arm (280 total).~   "
184690|NCT01147276|"~     The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon~     counterregulatory response to hypoglycemia in type 1 diabetes.~   "
184691|NCT01147263|"~     Clinically Characterized by the presence of chronic widespread pan and tenderness,~     Fibromyalgia (FM) is one of the most common functional syndromes. FM is currently conceived~     of as representing a prototype of central pain, i.e. a condition in which sensitization of~     the central nervous system results in a overall increase in the processing of painful~     stimuli, as well as an impairment of pain inhibition. This condition is responsible for~     significant a social and economic burden and is estimated to affect up to 5% of all women.~     The 1990 American College of Rheumatology (ACR) classification criteria for FM are the~     current standard for studying FM, and require the presence of widespread pain lasting over 3~     months, as well as documentation of tenderness in at least 11 of 18 pre-defined tender~     points. Multiple additional symptoms, which are not part of the classification criteria,~     include among others sleep disturbances, mood disturbances, cognitive dysfunction,~     vulvodynia, dysmenorrhea, sexual dysfunction and weight fluctuations. In addition, FM is well~     known to overlap both clinically and epidemiologically with an ever increasing number of~     other functional disorders, including irritable bowel syndrome (IBS), Temporomandibular~     joint disorder (TMJD), functional dyspepsia etc. In addition to the central symptom of pain,~     FM patients frequently complain of non- specific symptoms which are potentially autonomically~     - mediated. Thus, palpitations, fatigue and inability to stand for long periods of time are~     all common complaints. About 80-90 percent of FM patients have one or more symptoms~     associated with autonomic dysfunction. The most common of them is presyncope (62.5%),~     followed by syncope (12.5%), palpitations on standing (12.5%) and dizziness (12.5%) (14).~     Some of these symptoms overlap with those of the postural tachycardia syndrome (POTS). POTS~     is a common dysautonomia, characterized by remarkable increased heart rate during the~     assumption of the upright posture (>30 bpm). According to our experience, FM is found, at~     least, in 15% of POTS patients. But, no data exists about the incidence of POTS in patients~     with FM.The role of the autonomic nervous system (ANS) in initiating and maintaining the~     syndrome of FM has been studies (and debated) over the last decade. The ANS is an extremely~     complex system, regulating involuntary body functions, including heart rate, intestinal~     motility, urination, and sexual activity, among many other variables. Notably, the vagus has~     an inhibitory effect on pain. Deterioration in the vagal control is associated with~     increased pain sensation. Previous studies have indicated that FM patients may have an~     increase in sympathetic control over the cardiovascular system with a reciprocal decrease in~     parasympathetic control. High sympathetic tone is usually associated with a lower threshold~     to pain. But, the contribution of the ANS to the pathogenesis of FM syndrome remains unclear.~     Evidently, the ANS interacts with other components of the CNS in the pathogenesis of FM,~     including pain processing centers in the thalamus and amygdala, as well as with the~     hypothalamic-pituitary-adrenal (HPA) axis.~   "
184692|NCT01147250|"~     Primary Objective:~      - To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality~     (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke,~     hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who~     recently experienced an acute coronary syndrome (ACS) event.~      Secondary Objectives:~      To demonstrate that when compared to placebo, lixisenatide can reduce:~        -  composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for~          unstable angina, or hospitalization for heart failure.~        -  composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for~          unstable angina, hospitalization for heart failure, or coronary revascularization~          procedure.~        -  urinary albumin excretion (based on the urinary albumin/creatinine ratio).~      To assess the safety and tolerability of lixisenatide.~   "
184693|NCT01147237|"~     The utilization of everolimus-eluting coronary stents in a coronary artery diseases is~     effective in reducing both repeat revascularization and major adverse cardiac events within~     two year follow-up. To evaluate the procedural, short and long term clinical outcomes of~     multiple everolimus-eluting coronary stent implantation in long (>30mm) coronary lesions.~   "
184694|NCT01147224|"~     The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent~     asthma including or excluding allergic components over 3 months, especially in the spring~     season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further~     data on safety and tolerability of Alvesco .~   "
184695|NCT01147211|"~     This is a phase I study of MK2206 (an AKT inhibitor)and gefitinib in nonsmall cell lung~     cancer patients who failed prior chemotherapy and epidermal growth factor receptor-tyrosine~     kinase inhibitor (EGFR-TKI). The patient population is enriched for EGFR mutations.~      The purpose of this study is to determine whether it is safe to administered MK-2206 in~     combination with gefitinib in adult patients with locally advanced or metastatic non-small~     cell lung cancer. The second purpose of this study is to define the MTD (Maximum Tolerated~     Dose) of MK-2206 when combined with gefitinib.~      A standard 3-3 dose escalation scheme of MK-2206 with fix dose gefitinib is used in this~     study.~   "
184696|NCT01147198|"~     Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe~     malnutrition. Their efficacy and effectiveness were proven in community therapeutic care~     programs. Recently, the question rose if RUTF would be more effective than enriched flours to~     treat moderate malnutrition.~      The purpose of this study is to compare the effectiveness of Ready to Use Food~     Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain,~     duration of treatment, morbidity and mortality in the treatment of moderate acute~     malnutrition.~      Compare the longer term effect on nutritional status and morbidity (relapse?).~   "
184697|NCT01147185|"~     The purpose of this study is to determine whether longer locomotor training results in a mor~     favorable outcome in patients with incomplete spinal cord injury.~   "
184698|NCT01147172|"~     Elevess is intended for all skin types. However, further study of all soft tissue fillers is~     needed in people of color because of the increasing use of cosmetic dermal filler products.~      This study is designed to evaluate the safety of an injectable hyaluronic acid based dermal~     filler Elevess (Anika Therapeutics, Inc., Bedford, MA). Safety will be evaluated by incidence~     and severity of keloid formation and pigmentation changes, and other potential adverse events~     in people with Fitzpatrick skin types IV, V and VI who have elected to undergo nasolabial~     fold (NLF) treatment with Elevess.~      1. Fitzpatrick Classification of Skin Type as: IV - Burns minimally, always tans well~     (moderate/light brown skin; Mediterranean, Asian, Hispanic. V - Rarely burns, tans profusely~     (dark brown/brown skin: Middle eastern, Latin, light skinned Black, Indian) VI - Never burns,~     (deeply pigmented dark brown to black skin;Black)~   "
184699|NCT01147159|"~     Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic~     and non-allergenic components. Many factors such as the biovariability, differences in~     extraction process and subsequent handling of allergens can affect the final composition,~     potency, and stability of allergen preparations. Genetic diversity of affected people adds~     another level of complexity. In order to control variability and to achieve consistency and~     reproducibility for optimal safety and sensitivity/specificity, it is essential to~     standardize the amount of allergen used in prick tests. Therefore, the system for biological~     standardization mainly used in Europe still is the biological calibration of in-House~     Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines~     as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT)~     value. The aim of this procedure is to estimate the biological activity of allergen extracts.~     The activity of an allergen extract is defined as 10,000 Diagnostic Biological Units (DBU)~     per ml (1 SPT per ml), when the extract provokes a specific skin reaction with a wheal of the~     same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when~     both solutions are administrated using the same technique (prick testing) on at least 20~     individuals who are clinically allergic and cutaneously reactive to the allergen concerned.~      The present study aims to standardize the allergen extracts of Betula pendula, Phleum~     pratense and Dermatophagoides pteronyssinus by using this method.~        -  Trial with medicinal product~   "
184700|NCT01147146|"~     The effects of anesthetic method on cerebral oxygen saturation in geriatric patients~     undergoing transurethral surgery.~   "
184701|NCT01147133|"~     Clopidogrel is essential for the prevention of vascular events in patients after percutaneous~     coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from~     the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the~     original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has~     expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the~     market. Some of the generics are using the original bisulphate formulation, while others are~     with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the~     different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each~     drug. As the consequences of the impaired antiplatelet potency might be devastating,~     including stent thrombosis, the investigators sought to compare generic clopidogrel to the~     original blister by different assays of platelet aggregation.~   "
184702|NCT01147120|"~     Kentucky ranks 2nd in disability among states, with chronic low back pain (CLBP) as a major~     disability, especially in the investigators rural areas. Kentucky and U.S. health care~     providers need alternative and effective treatments. Following NCCAM strategic research~     recommendations, this study will investigate health services outcomes of complementary and~     alternative medicine (CAM) therapies in an existing primary care practice-based research~     network (PBRN). The Patients with CLBP are often willing to try therapeutic options outside~     the conventional medical spectrum. Massage and relaxation therapies have demonstrated fairly~     good efficacy in controlled trials but their effectiveness in the real world of primary~     care is only beginning to be evaluated. The long-term goal of the proposed project builds on~     the foundation of these two established therapies to improve treatment of chronic low back~     pain (CLBP) in primary care practices. Two alternative (CAM) therapies, progressive muscle~     relaxation (PMR) and clinical massage therapy (CMT), will be studied. The short-term~     objectives of the proposed project are to: (1) examine outcomes of CAM for patients with CLBP~     referred from primary care practices, and (2) better understand physician decision-making to~     recommend CAM therapy for CLBP. Specific Aim 1 will evaluate improvement in health-related~     outcomes for patients with CLBP when referred to PMR or CMT from primary care. Specific Aim 2~     will explore selected factors in primary care physicians' decisions to recommend CAM therapy~     to these patients. The proposed study is unique in that it addresses real life clinical~     situations and decision-making in both urban and rural clinical practices within an existing~     PBRN. Should such CAM referral prove successful for ameliorating CLBP, it would provide~     relatively low cost, non-addictive treatment options for inclusion in the repertoire of~     primary care physicians.~   "
184703|NCT01147107|"~     The main objective is to evaluate the hepatic safety of raltegravir when compared to~     efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment~     in patients with HIV and hepatitis C coinfection.~   "
184704|NCT01147081|"~     Annual trial for registration influenza vaccine Begrivac with strain composition for season~     2010/2011.~   "
184705|NCT01147068|"~     The purpose of this study is to investigate the safety and immunogenicity of a recombinant~     hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at~     4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA~     formulations.~   "
184707|NCT01147042|"~     Background:~      - Chronic granulomatous disease (CGD) is an immunodeficiency disease in which white blood~     cells are unable to kill certain bacteria and fungi. People with CGD are more likely to~     develop recurrent life-threatening infections. Certain changes or mutations in genes~     contribute to the severity of CGD, and also appear to affect the success of treatment with~     interferon-gamma, a substance that is used to improve the immune system s ability to fight~     infection. Researchers are interested in studying changes in the immune system caused by~     interferon-gamma treatment of CGD in individuals with different mutations that cause CGD.~      Objectives:~      - To compare changes in the immune system caused by interferon-gamma treatment for CGD in~     individuals with different mutations that cause CGD.~      Eligibility:~      - Individuals of any age who have been diagnosed with CGD and have specific types of~     mutations that cause CGD (to be determined after testing).~      Design:~        -  Participants will be screened with a medical history, physical examination, and blood~          and urine tests. Participants must weigh more than 11 kilograms (~24 pounds) to~          participate in the study.~        -  Participants will receive injections of interferon-gamma once weekly for 4 weeks, twice~          weekly for 4 weeks, and then three times weekly for 4 weeks (a total of 24 injections).~        -  Blood will be drawn periodically during treatment and for 8 weeks after the treatment,~          for a total of 21 weeks on the study. Participants will regularly provide information on~          their symptoms and responses to treatment to the study researchers.~   "
184708|NCT01147029|"~     RATIONALE: GSAO may stop the growth of solid tumors by blocking blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of GSAO in treating~     patients with advanced solid tumors that have not responded to therapy.~   "
184709|NCT01147016|"~     RATIONALE: Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer~     followed by Her2Bi armed activated T cells (ATCs) may significantly improve the pathologic~     complete response (pCR) rate at the time of surgery. Arming ex vivo expanded T cells in the~     laboratory may help the T cells kill more tumor cells when they are put back in the body.~     Giving combination neoadjuvant chemotherapy followed by laboratory-treated T cells before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This phase II clinical trial is studying how well giving laboratory-treated T cells~     after neoadjuvant chemotherapy works in treating women with stage II or stage III breast~     cancer undergoing surgery.~   "
184710|NCT01147003|"~     This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients~     with partial onset seizures.~   "
184711|NCT01146990|"~     In the continuing efforts to understand the benefits and risks of in utero exposure to 17P~     this study is designed to evaluate differences in developmental outcomes of children, aged 23~     to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic~     (Protocol number 17P-ES-003).~   "
184712|NCT01146977|"~     Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with~     core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1).~   "
184713|NCT01146964|"~     The purpose of this study is to compare the safety and efficacy of manual super small~     incision cataract surgery (MSSICS) and Phacoemulsification.~   "
184714|NCT01146951|"~     To confirm that the combination therapy of rufinamide has superior efficacy compared to~     placebo in patients with Lennox-Gastaut syndrome.~   "
184715|NCT01146938|"~     To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in~     hepatic impairment patients and healthy volunteers~   "
184716|NCT01146925|"~     The primary objective of this trial is to assess the impact of CRMD-001 on markers of~     contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease~     (CKD) undergoing coronary angiography and PCI.~   "
184717|NCT01146912|"~     The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be~     administered annually to all children aged 6 months to 18 years as well as women who are~     pregnant during the influenza season. Nevertheless, targeting and mobilizing these~     populations has been difficult and influenza immunization rates nationwide remain low.~     Immunization reminder-recalls have been shown to be effective, but have had limited ability~     to rapidly identify and reach large target populations in a cost-effective manner. Evidence~     on how to optimally design these systems is not yet available and thus text message~     immunization alerts have not been widely implemented. The investigators propose to implement~     and evaluate tailored, targeted influenza text message reminders in urban pediatric and~     pregnant populations.~   "
184718|NCT01146899|"~     Childhood influenza coverage rates are far below rates for the other childhood vaccinations.~     Increasing influenza vaccine coverage rates is important not only for the health of the~     child, but for that of the child's household and community. Yet,influenza vaccine delivery~     rates at pediatric clinics are low, even when the vaccine is available. The proposed project~     will take advantage of existing health information technology to tailor, implement and~     evaluate influenza vaccine alerts in the electronic health record (EHR) for pediatric~     providers to help improve health care decision making.~   "
184719|NCT01146886|"~     The purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl.~     dose proportionality, and pharmacodynamics of BI 135585 XX (Part 1), as well as the relative~     bioavailability of two different immediate release tablet formulations versus oral solution~     (Part 2)~   "
184731|NCT01146730|"~     Mental disorders, mainly various anxiety and depressive disorders, are an increasing reason~     for sick leave and disability pension. Cognitive behaviour therapy (CBT) has been shown to~     have an effect on anxiety and depression, but the investigators know little about this in~     relation to employment. Close follow-up in ordinary employment increase employment~     participation for serious mental illness, but this is not yet investigated to the same degree~     for lighter mental disorders.~      Center for Work-Coping (No: Senter for Jobbmestring - SJM) combines Cognitive behaviour~     therapy (CBT) and individual placement and support (IPS) and facilitation of work for people~     with anxiety and depression who are in danger of falling out of work.~      The purpose of this project is to evaluate the effectiveness of the model in SJM. The effect~     will be evaluated through a randomized controlled trial (RCT) in which participants will be~     randomized to SJM or regular follow-up by The Norwegian Labour and Welfare Administration~     (NAV) or by their regular general practitioners (GP) and self-help resources. The main~     outcome measures are work participation with changes in mental health as a secondary outcome.~   "
184720|NCT01146873|"~     The investigators hypothesize that switching to a regimen based on efavirenz will be as~     effective and safe as remaining on a regimen based on Lopinavir/ritonavir for HIV-infected~     children.~      The investigators propose an unblinded randomized clinical trial to evaluate a~     simplification, protease-inhibitor (PI)-sparing treatment strategy among nevirapine~     (NVP)-exposed HIV-infected children treated initially with lopinavir/ritonavir (LPV/r).~     HIV-infected children aged 3-5 years, who have a history of exposure to NVP as part of~     prevention of mother-to-child HIV transmission (PMTCT), initiated LPV/r-based therapy in the~     first 36 months of life or who were enrolled on the control arm of Neverest 2 and who are~     virally suppressed with a viral load < 50 copies/ml will be included. These children will be~     randomized to either substitute efavirenz (EFV) for LPV/r or to continue on their LPV/r-based~     regimen. Eight weeks prior to the primary randomization, eligible children will also be~     randomized to either remain on stavudine (D4T) or switch to abacavir (ABC). Children will be~     followed with regular viral load and other clinical tests for 48 weeks after the primary~     randomization. Children in the experimental arm who have breakthrough viremia (-defined as~     two subsequent viral loads > 1000 copies/ml) on the EFV-based regimen will reinitiate the~     LPV/r regimen. The primary objective is to test whether the durability of viral suppression~     is equivalent when children are switched to EFV-based therapy. The primary study endpoint is~     failure to have HIV RNA < 50 copies/ml and/or confirmed viremia >1000 copies/ml. Secondary~     aims include comparison of immune preservation, toxicities, selection of resistance~     mutations, and adherence across the two arms. Antiretroviral drug concentrations and~     adherence will be investigated as possible explanations for the success and/or failure of~     this simplification regimen. The overall goal of the study is to contribute to the evidence~     base to allow expansion of treatment options for HIV-infected children in low resource~     settings.~   "
184721|NCT01146860|"~     The purpose of this study is to determine whether the dry extract BNO 1016 is effective and~     safe in the treatment of acute rhinosinusitis in adults.~   "
184722|NCT01146847|"~     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.~     Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of~     the intensive care unit staff difficulties were experienced in achieving efficient and safe~     glucose control. A fully automated algorithm may help to overcome some of these limitations~     by excluding intuitive interventions and integrating relevant clinical data in the~     decision-making process. Space GlucoseControl (TGC system) is a decision support system which~     helps to achieve safe and reliable blood glucose control in the desired ranges. Information~     on parenteral and enteral nutrition is automatically integrated into the calculations. The~     primary objective of the current study is to investigate the performance and usability of the~     Space TGC system for glucose control over an tight glucose control range (4.4 to 6.1 mmol/L)~     in surgical intensive care patients.~   "
184723|NCT01146834|"~     This phase III randomized trial compares three different peripheral stem cell mobilization~     regimens for patients with multiple myeloma who have received primary induction therapy or~     other therapies. Up to 180 patients will be enrolled. Patients eligible for treatment will be~     randomized to one of the three following mobilization regimens:~      Arm A = VELCADE, CYCLOPHOSPHAMIDE, G-CSF Arm B = VELCADE & G-CSF Arm C = CYCLOPHOSPHAMIDE &~     G-CSF~   "
184724|NCT01146821|"~     The primary objective of this trial is to determine the safety and efficacy of IV fish oil~     doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients~     with severe sepsis by examining organ function, blood safety and biochemical parameters,~     markers of systemic inflammation and innate immunological parameters~   "
184725|NCT01146808|"~     The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing~     de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts~     but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B~     naive patients). The second objective is to evaluate the efficacy of accelerated vaccination~     with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long~     antiviral therapy.~   "
184726|NCT01146795|"~     This study is to determine the feasibility of administering neoadjuvant carboplatin,~     paclitaxel, and bevacizumab without excessive dose modification or cycle delay in patients~     with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.~   "
184727|NCT01146782|"~     This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive~     sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the~     Attune Sleep Apnea System to support FDA marketing clearance of the device.~   "
184728|NCT01146769|"~     The aim of study is to investigate the difference in Maximum Squeeze Pressure in patients~     with and without pelvic floor muscle training in low anterior resection in peri-operative~     period~   "
184729|NCT01146756|"~     Two thirds of non small cell lung cancer patients present with locally advanced tumours~     (stage III) or metastatic disease (stage IV) and radiotherapy plays a major role in their~     treatment. Treatment (radiotherapy and chemotherapy) can be given with curative intent to~     selected patients with locally advanced, stage III disease. Patients with stage III tumours~     associated with a pleural effusion, and patients who present with advanced, metastatic~     disease (stage IV) are treated palliatively with no prospect of cure. In the latter,~     radiotherapy (RT) is offered with the aim of improving symptoms, achieving tumour control and~     optimising quality of life. It is generally believed that a plateau has been reached for~     combination of chemotherapy with radiotherapy lung cancer. There is a strong rationale for~     combining molecular targeted agents with irradiation. AZD6244 is a potent, selective,~     uncompetitive inhibitor of MEK that has been tested in early phase clinical trials either~     alone or in combination with chemotherapy in a variety of cancers including lung cancer.~     Preclinical studies have shown that AZD6244 enhances the effect of radiation. AZD6244 has not~     yet been combined with radiotherapy in clinical trials. In this study, a maximum of 18~     patients will be allocated to one of 3 doses of AZD6244 in combination with a standard dose~     of RT in a Phase 1 dose escalation/ de-escalation design to determine the recommended dose~     for Phase 2 trials (RP2D). An expanded cohort of 15 patients will be treated at the RP2D to~     obtain additional safety and preliminary response data. Patients will undergo 3 FLT positron~     emission tomogram (PET) scans, the first scan before treatment, second scan during AZD6244~     treatment and third scan during RT. All patients will also have tissue/blood samples~     collected for biomarkers. Biomarkers and FLTPET imaging will be examined to obtain~     information that may predict for response, resistance or toxicity to radiation and AZD6244.~   "
184730|NCT01146743|"~     The investigators would like to conduct a prospective, randomized non-inferiority study to~     compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and~     percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis~     patients.~   "
184732|NCT01146717|"~     This study is being done to find out whether regulation of brain blood flow is altered in~     patents with mild cognitive impairment (those who have memory problems but otherwise healthy)~     when compared with healthy elderly individuals. In addition, this study will determine~     whether exercise training improves brain blood flow, brain structure, and brain function in~     patients with mild cognitive impairment (MCI).~      This is a research study because at present the investigators know little about brain blood~     flow regulation in patients with mild cognitive impairment. The investigators also know~     little about whether exercise training improves brain blood flow, brain structure, and brain~     function in patients with mild cognitive impairment.~   "
185025|NCT01142830|"~     The primary objective is to assess the incidence and severity of pain after major craniotomy~     in paediatric patients (from 1 month to 10 years of age).~      The secondary objective is to determine factors associated with significant pain following~     paediatric neurosurgery .~   "
184733|NCT01146704|"~     The objective of this study is to test and determine whether a high protein diet is~     efficacious, safe and beneficial to curtail food intake and body weight in obese adult human~     patients and to establish whether neurohormonal mechanisms of a high protein diet induce an~     early signal of fullness or satiety in a relevant experimental model, focusing on activation~     of gastric vagal afferents.~   "
184734|NCT01146691|"~     Intensive Care Units (ICU) are an important, but troubled, part of modern health care~     systems. While it seems likely that both the technical and structural elements of ICU care~     are important determinants of relevant ICU outcomes, little is known about how the structure~     of ICU care affects outcomes. One element of potential importance is the way that ICU~     physicians (intensivists) organize themselves to provide ICU care, particularly at night. The~     dominant, historical (standard) model of intensivist staffing involves an intensivist who~     is present during daytime hours, but then takes call at night from home. But, in recent~     years there has been widespread concern about whether patients experience adverse events or~     worse outcomes related to a lesser level of expertise and care readily available at night in~     hospitals. Only two studies, both from single ICUs, and both using simple before vs. after~     study designs, have conducted interventional studies directly comparing a standard~     intensivist staffing model with a 24-7 model of nighttime intensivist coverage via shift~     work, i.e. with the daytime intensivist giving way at the late afternoon to a nightshift~     intensivist who remained in the hospital and covered the ICU until morning. Those two studies~     found contradictory effects of the intervention. But despite the absence of clear data~     indicating a benefit to ICU patients associated with having intensivists remain in the~     hospital overnight, there has been a major movement around the world towards ICU staffing~     models utilizing shift work to ensure such coverage. The potential impact of such a change in~     staffing paradigm is large, with possible effects on all the other major stakeholders~     involved in ICU care: families, nurses, and house officers. Both benefits and detriments are~     possible.~      On the one hand, moving to a shift work model from a model in which a single intensivist~     becomes overworked and sleep-deprived as a result of being responsible for care both day and~     night, has the potential to reduce the sleep deprivation, job distress, and burnout prevalent~     among intensivists with standard staffing models. But, it would also require more~     intensivists, a serious challenge given the worsening intensivist manpower shortage. Also,~     there are many detrimental effects of shift work on humans, including negative effects on~     motor function, cognition, sleep, job satisfaction, mood, errors, and cardiovascular health.~     Shift work is the most common reason that Emergency Medicine physicians give for leaving that~     field. The physical availability of an intensivist around-the-clock might also influence the~     problems mentioned of family dissatisfaction with communication in ICUs, and poor~     communication/ teamwork with physicians often perceived by ICU nurses. In ICUs of teaching~     hospitals, where relatively inexperienced house officers typically remain in the ICU~     overnight, the nighttime presence of an attending physician might influence residents'~     perceptions of domains such as teaching, and clinical autonomy.~      This purpose of this study is to rigorously compare the effects of two different intensivist~     staffing models, specifically the current standard model, and a 24-7 staffing model enabled~     via shift work. This study will be conducted in two ICUs, one academic with house officers~     who remain in ICU overnight (the Medical ICU at Health Sciences Center), and one in a~     community hospital which currently lacks overnight, in-ICU physicians (the Victoria General~     Hospital).~      This study is designed to improve upon both prior studies. To obviate the problems with using~     historical controls inherent in those before-vs-after study designs, our study will alternate~     the two staffing models (e.g. A-B-A-B). Also, the investigators will rigorously assess the~     effect of 24 hour intensivist presence on all major stakeholders, i.e. patients, families,~     intensivists, nurses, and house officers.~   "
184735|NCT01146678|"~     Primary Objective:~        -  to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and~          lixisenatide given subcutaneously as on-site mix versus separate and simultaneous~          injections of each drug~      Secondary Objectives:~        -  to compare the activity of a single dose of insulin glargine and lixisenatide given~          subcutaneously as on-site mix versus separate and simultaneous injections of each drug~        -  to assess the safety and tolerability of insulin glargine and lixisenatide given~          subcutaneously as on-site mix~   "
184736|NCT01146665|"~     Alcohol misuse amongst youth is a significant clinical and public health problem. The~     Emergency Department (ED) is an important setting for the treatment of alcohol-related~     problems as it is often the first point of contact between youth, their families, and the~     healthcare system. This pilot study will assess the feasibility and acceptability of a~     computer-based intervention in the ED for youth with alcohol-related presentations. The~     investigators research team will: (1) evaluate the methodological and operational processes~     involved in study recruitment and intervention implementation, (2) determine recruitment and~     retention rates, and (3) obtain preliminary data on the difference in alcohol consumption at~     different time points. The clinical and health service implications of this research will be~     used to plan further investigations designed to improve the standard of ED care among youth~     aged 12 to 16 with alcohol-related presentations. This research will also help optimize the~     planning and development of a full-scale randomized controlled clinical trial of a~     computer-based intervention designed to reduce higher-risk alcohol consumption and~     alcohol-related health and social problems in this target population.~   "
184737|NCT01146652|"~     Primary Objective:~      Assess the long term safety of sarilumab in patients with rheumatoid arthritis.~      Secondary Objective:~      Assess the long term efficacy of sarilumab in patients with rheumatoid arthritis.~   "
184738|NCT01146639|"~     Endovascular therapy of Aortic Aneurysms depends on good imaging facilities. A relatively new~     kind of x-ray equipment makes it possible to create computer tomography (CT) - like slice~     images in the operating room. The purpose of this study is to verify the clinical usefulness~     of DynaCT in a preoperative setting. To do so we compare aortic measurements in DynaCT to the~     same measurements in ordinary CT-images which are regarded the gold standard.~   "
184739|NCT01146626|"~     Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy~     obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3.~     Studies rarely address the issues of improving host factors. The current study examines~        1. whether adding vitamin D, a potent immunomodulator, could improve viral response and~          shorten treatment duration (from 24 weeks to 12 weeks)~        2. whether Vitamin D levels predictes negative treatment outcome.~   "
184740|NCT01146613|"~     The primary objective of this study is to assess the efficacy of varenicline in reducing the~     proportion of heavy drinking days during the last 8 weeks of treatment in subjects with~     alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text~     Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day~     for men and 8 or more drinks for women (designated as very heavy drinkers).~   "
184741|NCT01146600|"~     The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness~     and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is~     caused by a problem with the quality of sleep occurring at night, for instance when nighttime~     sleep is disrupted by frequent breathing pauses. In other cases, however, hypersomnia occurs~     even when nighttime sleep is of good quality. These cases of hypersomnia are presumed to be a~     symptom of brain dysfunction, and so are referred to as hypersomnias of central (i.e., brain)~     origin.~      The causes of most of these central hypersomnias are not known. However, our group has~     recently identified a problem with the major brain chemical responsible for sedation, known~     as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance~     that causes the GABA receptor to be hyperactive. In essence, it is as though these patients~     are chronically medicated with Valium (or Xanax or alcohol, all substances that act through~     the GABA system), even though they do not take these medications.~      Current treatment of central hypersomnias is limited. For the fraction of cases with~     narcolepsy, there are FDA-approved, available treatments. However, for the remainder of~     patients, there are no treatments approved by the FDA. They are usually treated with~     medications approved for narcolepsy, but sleep experts agree that these medications are often~     not effective for this group of patients.~      Based on our understanding of the GABA abnormality in these patients, we evaluated whether~     clarithromycin (an antibiotic approved by the FDA for the treatment of infections) would~     reverse the GABA abnormality. In a test tube model of this disease, clarithromycin does in~     fact return the function of the GABA system to normal. The investigators have treated a few~     patients with clarithromycin and most have felt that their hypersomnia symptoms improved with~     this treatment.~      To determine whether clarithromycin is truly beneficial for central hypersomnia, this study~     will compare clarithromycin to an inactive pill (the placebo). All subjects will receive both~     clarithromycin and the placebo at different times, and their reaction times and symptoms will~     be compared on these two treatments to determine if one is superior. If this study shows that~     clarithromycin is more effective than placebo in the treatment of hypersomnia, it will~     identify a potential new therapy for this difficult-to-treat disorder.~   "
184742|NCT01146587|"~     The GangTrainer GT I and the Lokomat have proven their effectiveness on stroke Patients, but~     a comparison on the same controlled study population has not been made so far. Aim of the~     study will not only be to establish which device will work better on acute, non ambulatory~     stroke Patients in terms of regain of gait ability and motor function, but also clinical~     matters, like the efficacy of the treatment period. As a result of the trial it should be~     highlighted which kind of therapy has to be suggested for Patients comparable to the study~     population. A significant better outcome of one device in regard to the other will suggest to~     use one device more than the other for future treatments.~   "
184743|NCT01146574|"~     This is the first study in hemodialysis subjects with anemia to evaluate the~     pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept~     (ACE-011)~   "
184744|NCT01146561|"~     Tanezumab is effective in reducing the pain associated with chronic pancreatitis.~   "
184769|NCT01146236|"~     The trial is a randomized, controlled trial. Adult patients undergoing orthopaedic surgical~     procedures would be randomized to one of two groups for surgical wound closure, skin sutures~     or skin staples. The primary outcome measures would be surgical site infection indicated by~     the use of oral or intravenous antibiotics for suspected wound infection and/or re-operation~     at the same site. Patients would be followed up as per their usual post-operative course for~     a total of three months in the trauma and spine population and six months in the total joint~     arthroplasty population. It is hypothesized that wounds closed with sutures and staples will~     have similar infection rates as defined by the use of antibiotics or reoperation.~   "
184745|NCT01146548|"~     This is a French national trial, conducted using a double-blind, placebo-controlled,~     randomised design involving 15 centers and 88 patients of both sexes.~      The primary objective of the trial is to evaluate the effect of a selective inhibitor of~     serotonin reuptake, the Fluoxétine, at a higher dose (40 mg/day) than usually recommended for~     depressed patients, after three months in patients suffering from an atypical Parkinson's~     disease called Multiple System Atrophy, compared to the placebo effect.~      Secondary objectives of the trial are the evaluation of the effects of Fluoxétine after six~     weeks at the dose of 20 mg/day, after six months at the dose of 40mg/day, and assess the~     effects on mortality, quality of life, autonomic disorders, particularly orthostatic~     hypotension, mood and others symptoms such as sleep, apathy, pain and fatigue.~   "
184746|NCT01146535|"~     This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in~     combination with oseltamivir (Tamiflu) to treat influenza.~   "
184747|NCT01146522|"~     This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients~     with severe hypertriglyceridemia.~   "
184748|NCT01146509|"~     The purpose of this extension study was to evaluate the safety and efficacy of donepezil~     hydrochloride after extended use in migraine prophylaxis. Efficacy will continue to be~     evaluated.~   "
184749|NCT01146496|"~     A major global public health priority is to identify effective methods for preventing deaths~     from pesticide self-poisoning. The aim of this work is to determine whether the provision of~     lockable storage containers to poor households in rural Asia can reduce the incidence of~     intentional pesticide self-poisoning. Secondary questions include the effect of these~     containers on unintentional pesticide poisoning in children and overall self-harm.~   "
184750|NCT01146483|"~     This is a single-center, randomized, 2-period, 2-sequence, cross-over study.~   "
184751|NCT01146470|"~     The study hypothesis is that 3 Months Daily Supplementation of RGC will effect blood pressure~     and vascular function.~      This will be a single-center, double-blind, random, parallel controlled Study. Study~     population will include 60 subjects, who will be divided randomly into three groups. The~     first group will get RGC 200mg, the second group will get RGC 400mg, and the third group will~     get 200mg placebo.~   "
184752|NCT01146457|"~     The purpose of this study is to determine the ideal dosage of intrathecal morphine for intra~     and post partum analgesia, while minimizing the side effect profile.~   "
184753|NCT01146444|"~     Part I: to investigate the efficacy of different sunscreens in the prevention of skin lesions~     following standardized photoprovocation with Ultraviolet A/Ultraviolet B (UVA/UVB) light in~     patients with CLE.~      Part II: to evaluate the influence of different sunscreens on the expression of biomarkers in~     the skin of patients with CLE and of Healthy Controls following UV irradiation.~   "
184754|NCT01146431|"~     The purpose of this study is 1) to investigate whether the use of BIS as a guide to the~     administration of inhaled anesthetic (sevoflurane or desflurane) compared with the use of~     hemodynamic parameters (blood pressure and heart rate) would affect the occurrence of~     implicit memory and /or dreams recall and 2) to check whether the occurrence of implicit~     memory and/or dreams recall is related with MAC (Minimal Alveolar Concentration) of~     inhalational anesthetics and/or preoperative anxiety levels.~   "
184755|NCT01146418|"~     The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after~     the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single~     injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle~     stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled~     ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm~     injection (ICSI).~   "
184756|NCT01146405|"~     1. To investigate whether the auditory stimulation causes changes in hormones levels~          (cortisol+prolactin) during general anesthesia.~        2. To determine if there is a correlation between hormones levels (cortisol+prolactin) and~          dreams recall.~        3. To investigate whether, in patients receiving auditory stimulation, there is a~          correlation between hormones levels (cortisol+prolactin), serum remifentanil~          concentration and detection of implicit memory.~        4. To investigate the presence of primary auditory cortex activation (temporal lobe) in~          patients with implicit memory and in those with dreams recall using the EEG-ERP 128~          channels GES300 EGI system.~   "
184757|NCT01146392|"~     The aim of this study is to describe COPD health care and to assess demographics, concurrent~     diseases and mortality and the use of pharmaceuticals for a chronic obstructive pulmonary~     disease (COPD) population in real life in primary care during the last ten years.~   "
184758|NCT01146379|"~     Arm weakness happens a lot after a stroke. People often get physical or occupational therapy~     after their stroke to learn how to use their arm again. This study will help figure out how~     much therapy should be given to restore as much arm function as possible.~   "
184759|NCT01146366|"~     To prospectively look at the utility of routine cervical mediastinoscopy (lymph node biopsy)~     in patients with clinically staged T2N0M0 NSCLC, as well as patients with clinically staged~     T1N0M0 NSCLC with a high maxSUV of the primary tumor on PET imaging.~      Hypothesis #1: The prevalence of mediastinal lymph node metastases detectable by cervical~     mediastinoscopy is sufficiently low (<10%) to not support the routine use of this test in the~     study population.~      Hypothesis #2: The preoperative detection of occult(hidden) N2 lymph node metastases by~     cervical mediastinoscopy in patients with clinically staged T2N0M0 NSCLC or T1N0M0 NSCLC with~     maxSUV >10 on PET does not provide a survival benefit when compared to detection of occult N2~     lymph node metastases at the time of thoracotomy using nodal dissection or systematic~     sampling.~   "
184770|NCT01146223|"~     This research study is studying biomarkers in patients with acute promyelocytic leukemia.~     Studying samples of bone marrow from patients with cancer in the laboratory may help doctors~     learn more about changes that occur in DNA and about biomarkers related to cancer.~   "
184771|NCT01146210|"~     This research study is studying identification of de novo Fanconi anemia in younger patients~     with newly diagnosed acute myeloid leukemia. Studying samples of tissue from patients with~     cancer in the laboratory may help doctors identify and learn more about biomarkers related to~     Fanconi anemia in patients with acute myeloid leukemia.~   "
191735|NCT01054651|"~     The purpose of this study is to determine the comparative efficacy of artesunate plus~     sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children~     infected with S.mansoni in western Kenya.~   "
184760|NCT01146353|"~     Pharmacokinetics for peramivir have not been well characterized in patients undergoing~     continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration~     (CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients~     with acute kidney injury for metabolic correction, slow continuous fluid removal, and to~     maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and~     dosing regimens often need alteration in patients receiving CRRT. Doses required to generate~     predictable serum concentrations can be calculated from known patient parameters such as~     replacement fluid and dialysate flow rate, sieving coefficients, and desired serum~     concentrations. However, pharmacokinetic studies must be performed in CRRT patients to~     generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by~     conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to~     differences in ultrafiltration rates and dialysis membranes. The investigators propose an~     open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.~   "
184761|NCT01146340|"~     The purpose of this study is to determine the safety and efficacy of a short course of~     radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk~     prostate cancer.~   "
184762|NCT01146327|"~     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The~     primary purpose of this trial is to evaluate the safety and tolerability, and~     pharmacodynamics, of multiple oral doses of PF-04620110.~   "
184763|NCT01146314|"~     The purpose of this study was to determine if a family-focused lifestyle intervention helps~     to improve the health status, behaviors, and adjustment of overweight children.~   "
184764|NCT01146301|"~     As with coronary artery stenting, activation and embolisation of platelets occurs with~     carotid artery stenting (CAS). Based on promising data on the use of clopidogrel plus aspirin~     in coronary stenting this dual antiplatelet regimen has been introduced as adjunctive~     treatment during CAS. There is as yet, however, no randomized controlled trial which compared~     different loading doses of clopidogrel during CAS. Taking into account that a wide~     interindividual variability in the response to a loading of clopidogrel exists, this study is~     intended to establish the optimal loading dose of clopidogrel. Therefore platelet function~     testing and a 1-hour of postprocedural TCD (transcranial doppler) monitoring will be~     performed.~      Objective: Firstly, to investigate whether the absolute magnitude of Platelet Inhibition~     inversely correlates with the number of TCD-detected microemboli during and after CAS in~     patients who are being pre-treated with either a 300 mg or a 600 mg loading dose of~     clopidogrel. Secondly, if there is any impact on early neurological outcome determined by the~     loading dose of clopidogrel.~   "
184765|NCT01146288|"~     Background:~      Obesity is associated with a high prevalence of chronic kidney disease.The glomerular~     hyperfiltration associated with obesity may play a role in the pathogenesis of obesity~     associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological means~     may slow down the development and progression of chronic renal failure. The investigators~     have previously shown that acetazolamide, a proximally acting diuretic that activates~     tubuloglomerular feedback(TGF) by increasing solute delivery to the Macula DENSA, abates~     glomerular hyperfiltration. The present study was designed to test the hypothesis that this~     decrease in hyperfiltration is specific to acetazolamide and not due to a non specific~     diuretic effect. The aim of the present study is to compare the effects of furosemide and~     acetazolamide on glomerular hemodynamics in subjects with severe obesity.~      Methods:~      A randomized double-blind crossover controlled design will be used. Fifteen obese subjects~     and ten subjects with normal body weight will participate in the study. Obese subjects will~     undergo measurement of glomerular filtration rate (GFR)(inulin clearance), renal plasma flow~     (RPF) (p-aminohippuric acid clearance), filtration fraction, fractional excretion of lithium~     (FE LI) and blood pressure, before and after intravenous administration of furosemide 2 mg.~     and acetazolamide 5 mg/kg BW. Ten subjects with normal body weight will undergo measurement~     of renal function without administration of diuretics.~   "
184766|NCT01146275|"~     Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had~     Macrolane deposits in the breast when the last study visit was performed. An additional~     follow up visit is planned to follow duration and safety of the former formulation of~     Macrolane that was used in the Pilot study (CTN 31GB0106).~   "
184767|NCT01146262|"~     Dendritic cells vaccinations are increasingly used in order to develop antitumoral immune~     response. This will be a Phase 2 trial using autologous dendritic cells pulsed with leukemic~     apoptotic corpse in acute myelogenous leukemia (AML) patients in first or second Complete~     remission (CR).~   "
184768|NCT01146249|"~     Among the components of postural control, sensorial integration is of crucial importance. The~     most important sensorial inputs for postural maintenance are the vestibular system which~     provides information regarding accelerations of the head in space (HORAK 1994), the~     somatosensory system which provides proprioceptive information that are used to determine~     changes in body position (INGLIS 1994) and the visual system which provides information for~     self motion in the environment. The receptors and the integration channel of each sensorial~     system have inner characteristics which lead to different performance of the different input~     in regards to the task and the environmental context (FITZGERALD 1994). Most of time,~     sensorial information are congruent but sometimes they are conflicted. This is the case when~     being in a stationary train, the train beside going on, giving the illusory sensation of~     movement even if the vestibular system is not activated. A sensory weighting process is then~     necessary for subjects to control balance. The Central Nervous System (CNS) is thought to~     adjust the relative contribution of sensory input to control stance depending on~     environmental conditions (CENCIANNI 2006) and the reliability of the sensory input (OIE 2002,~     KESHNER 2004) in order to maintain or achieve the desired orientation in space and to provide~     postural stability. Nevertheless the interconnection of the multiple sensorial feedback~     involved in the postural control is not yet completely understood (CHIARI 2000).~      Today, there is no tool available to evaluate the individual use of the sensorial information~     to postural control. It seems interesting to have such a tool to better understand the~     sensorial preference of subjects. It would be of particular importance for patients with~     various pathologies in the aim to design individualized balance rehabilitation programs.~      The aim of the study was to test a tool built to evaluate the sensorial preference of~     subjects by studying their postural reaction related to the 3 main sensorial perturbations.~     Normal subjects will be first tested to assess the repeatability of the protocol and to~     collect normal values. Then, patients with post stroke hemiplegia, vestibular disease,~     neuropathy and fallers will be studied in order to test the feasibility of the protocol and~     to have preliminary data of sensorial preference among these populations.~   "
184772|NCT01146197|"~     Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain~     some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts~     are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to~     cardiac and muscles symptoms.~   "
184773|NCT01146184|"~     The aim of this study is to improve the technique of laparoscopic cholecystectomy by using a~     flexible endoscope passed through a single umbilical skin incision, as previously reported,~     now with the use of Manually Articulating Devices (Ethicon Endo-Surgery, Inc.) through the~     endoscope.~   "
184775|NCT01146158|"~     Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM),~     involves retrieving all breast related nodes while leaving intact the main lymphatic drainage~     chain of the upper limb. This represents a new surgical technique that is the focus of recent~     surgical interest.~   "
184776|NCT01146145|"~     This is a randomised, controlled, double blinded study comparing in the postoperative setting~     the analgesic efficacy, the safety and the cost in two groups of patients receiving in the~     postanesthesia care unit either intravenous morphine titration alone or intravenous morphine~     titration combined to ketamine.~   "
184777|NCT01146132|"~     The study will provide evidence of eating habits and physical activity in cerebrovascular~     patients in Luxembourg and of the degree to which these habits may be changed acutely (after~     one month) and in the long run (after 4 months) by intensive counselling. Furthermore the~     influence of intensive counselling and of the consumption of red wine on cerebrovascular risk~     factors, cognition, and on surrogate parameters for stroke will be assessed.~   "
184778|NCT01146119|"~     This is a multi-center, randomized, two stage, double-blind, placebo-controlled~     administration study comprising 200 healthy participants.~   "
184779|NCT01146106|"~     This is a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg~     Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in~     Healthy Volunteers.~   "
184780|NCT01146093|"~     This is a single Dose Two-Way Crossover Fed Bioequivalence Study of Pravastatin 80 mg Tablets~     of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy~     Volunteers.~   "
184781|NCT01146080|"~     Compared with bare metal stents (BMS), both paclitaxel-eluting stents (PES) and~     sirolimus-eluting stents (SES) significantly reduce angiographic restenosis and the need for~     repeat revascularization in coronary arteries across a broad range of patient and lesion~     types. However the increased risk of very late stent thrombosis represents a major concern~     for patients treated with both PES and SES. Optical coherence tomography (OCT), a new imaging~     technique based on the back reflection of near infrared light, enables real-time, full~     tomographic, in-vivo visualization of coronary vessel microstructure. Struts coverage and~     vessel response of drug eluting stent (DES) compared to BMS are the most immediate clinical~     applications of OCT. Thickness of coverage and strut apposition can be quantified at~     micron-scale level with a resolution 10-30 times higher than conventional intravascular~     ultrasound (IVUS). The objective of this study OCTEVEREST (Optical Coherence Tomography for~     EVERolimus Eluting STent) is to evaluate the long term struts coverage and vessel wall~     response (abnormal intraluminal defects, strut malapposition, vessel expansions) to the~     PROMUS™ Everolimus Eluting Stent compared to PROMUS ELEMENT™ Everolimus Eluting Stent~     implanted for the treatment of stenosis in native coronaries. To investigate the completeness~     of struts coverage as well as the proportion of malapposed struts and the neointima~     characteristics, high resolution (~ 10 µ axial) intracoronary Optical Coherence Tomography~     (OCT) and intravascular coronary ultrasound (IVUS) will be used.~   "
184782|NCT01146067|"~     This is a bioequivalence study of Rivastigmine 1.5 mg capsules and Exelon Administered as 1.5~     mg capsule in Healthy subjects under fasting conditions.~   "
184783|NCT01146054|"~     This multi-institutional trial aims to evaluate the potential benefit and side effects of~     adding fractionated stereotactic body radiotherapy/surgery (SBRT) before and after~     chemotherapy with gemcitabine for locally advanced pancreatic cancer.~   "
184784|NCT01146041|"~     The purpose of this bioequivalence study is to compare the test of Rivastigmine 1.5 mg~     Capsules of Dr.Reddy's Laboratories Limited with reference to Exelon 1.5 mg of Novartis in~     Healthy Subjects Under Fed Conditions.~   "
184785|NCT01146028|"~     The purpose of this bioequivalence study is to compare the test Tizanidine Hydrochloride 4mg~     tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in~     healthy adult subjects under fasting conditions.~   "
184786|NCT01146015|"~     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in~     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of~     these vaccines are required to be involved in ongoing clinical trials and to present the~     results to the competent authorities each year. The current study is a phase IIIa clinical~     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It~     is part of the ongoing clinical trial program for Influvac® and will be done to assess the~     immunogenicity and safety and tolerability of next season's trivalent influenza subunit~     vaccine in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and~     subjects >= 61 years of age (elderly)~   "
184787|NCT01146002|"~     This study is investigating the effect of sustained-release guanfacine (Intuniv) on~     language-based learning skills in children age 6-12 who are diagnosed with attention deficit~     hyperactivity disorder (ADHD).~   "
184788|NCT01145989|"~     The purpose of this study is to find out whether the new drug AT9283 will slow the growth of~     multiple myeloma. Side effects of AT9283 will also be closely monitored.~   "
184789|NCT01145976|"~     The purpose of this study is to reduce the regimen related toxicities and transplantation~     related mortality after allogeneic stem cell transplantation in adult acquired aplastic~     anemia (AA), the trials of reduced dose of Cy along with fludarabine and ATG were~     performed.11-21 The investigators preliminary data of randomized comparison of~     cyclophosphamide plus fludarabine versus cyclophosphamide alone in addition to anti-thymocyte~     globulin for the conditioning therapy in allogeneic hematopoietic cell transplantation for~     bone marrow failure syndrome supports reduced dose of Cy along with fludarabine and ATG.~      Conditioning regimen without Cy may reduce RRT because Cy-containing conditioning remains~     several RRT such as hemorrhagic cystitis, SOS and graft versus host disease (GvHD). Recently~     there were small trials of fludarabine and ATG (Flu-ATG) for the conditioning regimen of~     alloHSCT.22-24 These data raised the feasibility of fludarabine and ATG without Cy for~     patients with AA.~      This new conditioning regimen of Flu-ATG will be compared to standard regimen of Cy- ATG in a~     randomized controlled trial.~   "
184790|NCT01145963|"~     Investigators are interested in learning how appetite responds to pasta containing different~     amounts of protein and fiber. In this research study, subjects will be asked to eat as much~     as they want of pasta containing different amounts of protein and fiber mixtures, thereafter~     subjects will describe their feelings of hunger, fullness and desire to eat for 3 hours~     afterwards. Subjects will be asked to do this on three separate occasions.~   "
184792|NCT01145937|"~     Rationale:~      Keratoconus is a progressive, non-inflammatory corneal disease in which irregular refractive~     properties of the cornea result in loss of visual acuity. Treatment is aimed at improving~     vision, principally using (rigid) contact lenses. With progression of the disease~     non-correctable refractive abnormalities and/or corneal scars arise. For these advanced~     stages of keratoconus, a corneal transplant is the only treatment modality.~      New surgical grafting modalities have been developed to create partial thickness grafts,~     according to the location of corneal pathology. For keratoconus, transplanting only the~     anterior corneal lamellae lowers long-term graft rejection rates. We utilize a method to~     enhance the safety of the grafting procedure while better visual outcomes are expected.~      Objective:~      To investigate the additional value of partial endothelial trepanation (PET) in an anterior~     lamellar keratoplasty (ALKP) procedure in terms of efficacy and safety in patients with~     keratoconus.~      Study design:~      A randomized controlled interventional trial~      Study population:~      Patients over 18 years old with keratoconus in whom contact lens correction is unsuccessful~     and who are not suitable for corneal crosslinking.~      Intervention:~      Patients will be randomly assigned to corneal grafting techniques; partial endothelial~     trepanation in addition to an anterior lamellar keratoplasty (i.e. the PET group) or a~     regular ALKP procedure.~      Study outcomes:~      Risk of per-operative perforation. Secondary, factors contributing to treatment safety and~     efficacy.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      There is no extra burden or risk associated with participation in this study. All~     measurements are part of normal clinical practice. Adequate experience is available with both~     surgical techniques. Study participation has no effect on donor selection. If partial~     endothelial trepanation (PET) is associated with lower complication rates and better visual~     outcomes, this might be beneficial in terms of morbidity.~   "
184793|NCT01145924|"~     Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes~   "
184794|NCT01145911|"~     To determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy~     progression.~   "
184795|NCT01145898|"~     To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive~     ocular blood flow and in relation to visual field progression and optic nerve structural~     changes in an ongoing 3 year prospective study involving 120 patients with open angle~     glaucoma.~   "
184796|NCT01145885|"~     Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of~     safety, tolerability and preliminary therapeutic effects of [14C]volasertib in patients with~     advanced solid tumours.~   "
184797|NCT01145872|"~     This research proposal is intended to elucidate the efficacy and mechanisms underlying~     Mindfulness Based Cognitive Therapy (MBCT) in a population in remission from recurrent Major~     Depressive Disorder (MDD). The first objective of the study is to replicate previous studies'~     findings of MBCT's effects on decreasing depressive symptoms and depression relapse rates.~     However, this proposal aims to make a novel contribution to the literature by using a~     randomized, controlled design, and comparing the effects of MBCT to an active control~     condition (ACC). The use of a well-designed ACC will enable us to control for confounding~     variables such as social support and expected outcomes, thus allowing us to determine whether~     elements specific to MBCT lead to its salutary effects (Aim 1). Previous MBCT studies have~     largely relied on self-report measurement methodologies, limiting valid conclusions about the~     nature of MBCT. Further, few studies have examined the mechanisms underlying effects of MBCT~     on depressive symptoms and relapse. Theoretical considerations and preliminary empirical~     evidence suggest emotional, physiological, and cognitive functioning to be promising~     mechanisms of MBCT. Therefore, the investigators propose to assess each of these potential~     mechanisms of MBCT using self-report, autonomic physiological, and reaction time tasks (Aim~     2). Collectively, these aims are expected to strengthen the evidence base for MBCT while~     cultivating a scientific model for its effects and mechanisms on decreasing depressive~     symptoms and depression relapse rates.~   "
184798|NCT01145859|"~     The first study with rivaroxaban in pediatric subjects is a Phase I study, where the~     pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to~     confirm that the exposure is comparable to adults. This study is a single dose study with~     multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism~     (VTE) treatment.~   "
184799|NCT01145846|"~     The purpose of this non-inferiority study is to compare the effectiveness of two induction~     chemotherapy regimens (cytarabine plus idarubicin [AI] versus cytarabine plus high-dose~     daunorubicin [AD]) in AML. The effectiveness will be evaluated in terms of complete remission~     (CR) rate.~   "
184800|NCT01145833|"~     The purpose of this study is to evaluate whether a home based program can teach parents and~     moderately overweight kids who are of 8-12 years old with a BMI% between 85-97%, how to~     manage their child's weight. The study uses manuals and involves a short visit to the clinic~     every other week.~   "
184801|NCT01145820|"~     The proposed study will test the following hypotheses:~        1. Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11~          weeks will result in reduced post-operative morbidity in terms of quality of life, pain~          and trismus after 1 week following surgical removal of lower third molars, when compared~          to placebo.~        2. Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11~          weeks will reduce serum markers of oxidative stress, following surgical removal of lower~          third molars, when compared with placebo.~   "
184802|NCT01145807|"~     The aim of this study is to establish the efficacy, clinical benefits, and safety of~     treatment with TDT 067 for clinically diagnosed distal subungual onychomycosis of the~     toenails caused by dermatophytes confirmed by positive mycology.~   "
184803|NCT01145794|"~     The high prevalence of smoking in adults in many developing countries (e.g. in China, 61%~     among men and 7% among women) results in many children being exposed to secondhand smoke~     (SHS). Although in 2001 the American Academy of Pediatrics recommended the promotion of~     proper smoking hygiene, (i.e. smoking away from the immediate environment of infants and~     children), similar recommendations in many developing countries are either scarce or~     non-existent. We hypothesize that implementation of a package of smoking hygiene intervention~     measures delivered by community health workers (CHWs) will reduce Chinese children's exposure~     to SHS and improve their respiratory health.~   "
184804|NCT01145781|"~     To evaluate whether single- and double-freeze cryotherapy techniques have similar efficacy in~     controlling different grades of cervical intraepithelial neoplasia (CIN), and have similar~     side effects and complications.~   "
184805|NCT01145768|"~     To investigate the safety and tolerability of TC-5214 following oral administration of single~     and multiple ascending doses compared to placebo.~   "
184806|NCT01145755|"~     This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in~     patients with major depressive disorder.~   "
185608|NCT01135147|"~     The goal of this research is to study the prevalence of sleep disordered breathing and~     associated morbidity in obese children and to examine the role of diet and physical activity~     in the treatment of sleep-disordered breathing in obese children.~   "
184807|NCT01145742|"~     Many primary care patients, especially in inner-city settings, do not achieve targets for~     blood pressure and glycemic control. There is an urgent need to enhance treatment for those~     who do not reach goals within the usual clinical care system. We propose to develop a~     multi-component intervention grounded in the Chronic Care Model, and sustainable in~     resource-challenged settings. Through collaboration with home health nursing and with the use~     of home telemetry for feedback and intensification of therapy, we will augment usual clinical~     services to improve health outcomes for diabetes patients who have not been able to reach~     therapeutic goals. There are three specific aims. First, we will establish a feasible,~     practical and sustainable collaborative model between the primary care sites of our~     practice-based research network (NYC RING), clinical researchers at the Diabetes Research and~     Training Center, and The Montefiore Home Health Organization, integrating the unique~     expertise of each of the partners and defining the roles and responsibilities of each.~     Second, we will develop and refine the components of the intervention, to include training~     primary care providers and home health nurses to integrate the technical, psychosocial and~     communication processes for implementation of the intervention. Third, we will assess the~     feasibility of the collaborative intervention by implementing the intervention for 25 primary~     care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25~     patients receiving usual care. Our proposal includes plans to develop feasible procedures for~     data collection, with qualitative and quantitative methods of assessing process and outcome~     measures. We will use these preliminary data to revise the intervention and prepare an R18~     application to further develop and test the intervention in multiple inner-city primary care~     sites serving low-income diabetes patients. This proposal is for secondary prevention of~     diabetes complications, targeting a population known for health disparities and a high burden~     from this chronic disease.~   "
184808|NCT01145729|"~     1. To do formative work with healthcare providers, clinic staff and parents to develop a~          protocol for a clinic system to routinely collect blood from children at risk of SHS~          exposure conduct laboratory testing for tobacco toxicants, document exposure in the~          electronic medical record (EMR) and incorporate the biomarker feedback into a parental~          smoking treatment plan.~        2. To pilot test effects of a clinic system to screen children at risk of SHS exposure with~          laboratory testing for tobacco toxicants on provider delivery of tobacco treatment~          services (primary outcome).~        3. To pilot test effects of a clinic system to screen children at risk of SHS exposure with~          laboratory testing for tobacco toxicants on parent smoking behavior (participation in~          smoking cessation treatment, smoking cessation and implementation of smoking~          restrictions).~   "
184809|NCT01145716|"~     The purpose of this study is to describe and stage lesions of the triangular fibrocartilage~     complex (TFCC) in association with distal radius fractures. 20 patients with dorsally~     dislocated AO type A fractures of the distal radius with sufficient displacement (based of~     cadaveric data) will be included. After stability testing and wrist arthroscopy. The TFCC is~     explored through a volar incision and injuries were documented and repaired from this~     approach.~   "
184810|NCT01145703|"~     The purpose of this study is to examine the effects of Vitamin D supplementation on the~     reasons (mechanisms) underlying the development of type 2 diabetes, metabolic syndrome (high~     blood pressure, cholesterol, diabetes, body weight/obesity), muscle weakness and wasting~     (sarcopenia), and impaired physical function (poor balance and walking) associated with~     vitamin D deficiency and osteopenia/osteoporosis (bone loss). The investigators obtain~     vitamin D through our diet and sunlight, and its conversion to active vitamins in the liver~     and kidneys promotes the intestinal absorption of calcium and regulation of bone growth.~     Therefore, vitamin D deficiency has been known for years to lead to weakened bones~     (osteopenia and osteoporosis). However, more recently, studies show vitamin D deficiency is~     associated with a number of other diseases, including type 2 diabetes, muscle weakness,~     frailty, and the metabolic syndrome. It has also been associated with cognitive impairment.~     Diabetes affects multiple organ systems including the heart, kidneys, musculoskeletal and~     nervous system. The possibility that vitamin D deficiency is linked to the development of~     type 2 diabetes, metabolic syndrome, muscle weakness and wasting (sarcopenia) and~     osteopenia/osteoporosis, and that vitamin D supplementation decreases the risk for these~     diseases, provides a relatively easy/accessible and inexpensive model of preventive therapy~     to decrease the incidence of these diseases. In addition, it is likely that genetic~     (inherited) factors play a role, but the relationship of these genes to these metabolic~     abnormalities have not been elucidated. Understanding the role of Vitamin D in health will~     allow us to translate these findings into therapy.~   "
184811|NCT01145690|"~     Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western~     world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the~     largest empirical support. However, the availability to CBT is very limited in Sweden due to~     lack of therapists with proper training. Therefore it is important to evaluate alternative~     forms of treatment that are more time efficient. One of these methods is Internet based~     self-help therapy, which has proven to be an effective treatment for social anxiety disorder.~      In this study, the investigators aim to conduct a follow-up assessment five years after~     completed Internet-based CBT. Participants received treatment within the context of a~     randomised controlled trial conducted in 2005. Thus, in the present study there will be no~     treatment interventions, only assessment.~   "
184812|NCT01145677|"~     This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with~     alcoholism~   "
184813|NCT01145664|"~     The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines~     for severe hand-foot-mouth disease.~   "
184814|NCT01145638|"~     The purpose of this study is to compare the efficacy and safety of intravenous iron therapy~     with oral iron therapy in patients with cancer and chemotherapy induced anaemia.~   "
184815|NCT01145625|"~     This is a year-long clinical trial to evaluate the effectiveness and safety in women with~     Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation~     applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.~      This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to~     evaluate if there is a change in the number of hairs in the area being examined after using~     the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).~      This trial will determine if the benefit of using either study product outweighs the risks.~   "
184816|NCT01145612|"~     The purpose of this study is to evaluate the efficacy of Losartan versus Atenolol in the~     progression of aortic dilatation in patients with Marfan syndrome.~   "
184817|NCT01145599|"~     The purpose of this study is to identify eyes that show worsening and disease progression~     (progressor phenotypes).~   "
184818|NCT01145586|"~     The primary objective is to determine the compared clinical efficacy of Lactase Eurofarma~     (test drug), showing non-inferiority to Lactaid® (comparative drug) in the supportive~     treatment of lactose intolerance and to assess the safety and tolerance of Lactase Eurofarma~     (test drug) in the supportive treatment of lactose intolerance.~   "
184819|NCT01145573|"~     Women between the ages of 18 and 45 are needed for a study that looks at the effect of~     calcium supplementation on bone health during pregnancy in black and white women. Study~     subjects will be divided into two groups. Each group will take 2 study supplements each day,~     the supplement will be calcium or placebo (a pill without calcium). The study involves five~     visits to the Children's Hospital of Oakland Research Institute; each visit will be 1-2 hours~     in length. There are 3 study visits during pregnancy and 2 in the first year after delivery.~     At each visit you will have your blood drawn and be asked questions about what you eat and~     what type of activities you do. At visit 16 and 36 weeks and 4 and 12 months postpartum you~     will have your bone density measured. You will be paid $240 for completing the study.~   "
184820|NCT01145560|"~     The primary purpose of this study to evaluate the effect of two different doses of AZD9773~     (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the~     start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are~     already receiving appropriate standard of care treatment for sepsis.~   "
184821|NCT01145547|"~     Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.~      Objective: The aim was to determine the impact of low vs high glycemic index (GI) on~     post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous~     glucose monitoring.~      Design: Seven adult subjects with type 1 diabetes participated in two experiments, each~     consisting of two meals each. In one experiment, both meals had a low GI; in the other, high~     GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat~     content. Each subject received his usual pre-prandial insulin dosage, followed by a~     continuous subcutaneous basal insulin infusion for the remainder of the experiment.~     Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded~     every 5 minutes.~   "
184822|NCT01145534|"~     The purpose of this study was to investigate whether the infusion of a medicinal plant~     (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of~     type 2 Diabetes patients.~   "
184823|NCT01145508|"~     This randomized phase II trial studies how well docetaxel and prednisone with or without~     vaccine therapy works in treating patients with hormone-resistant prostate cancer that has~     spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and~     prednisone, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from~     an antigen may help the body build an effective immune response to kill tumor cells. It is~     not yet known whether docetaxel and prednisone are more effective with or without vaccine~     therapy in treating prostate cancer.~   "
184824|NCT01145495|"~     This phase II trial studies how well lenalidomide and rituximab work in treating patients~     with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.~     Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in~     different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab,~     may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide~     together with rituximab may kill more cancer cells.~   "
184825|NCT01145482|"~     The study described in the present application will test the hypothesis that insulin mediated~     facilitation of memory in Alzheimer's disease (AD) is achieved through enhanced glutamatergic~     neurotransmission due to improvements in cerebral glucose metabolism. The effect of a single~     dose of intranasal insulin on memory and cerebral glutamate concentrations in adults with~     mild AD or amnestic mild cognitive impairment (aMCI), the presumed prodromal phase of AD will~     be studied. Successful completion of this study may set the stage for a larger-scale~     treatment trial of intranasal insulin for adults with memory disorders. However, the use of~     insulin in this manner at this point in time is purely experimental.~   "
184826|NCT01145469|"~     RATIONALE: Studying samples of DNA in the laboratory from patients who received~     fludarabine-based treatment may help doctors learn more about the effects of fludarabine on~     cells. It may also help doctors understand how well patients respond to treatment.~      PURPOSE: This research study is studying DNA samples from patients with chronic lymphocytic~     leukemia previously treated with fludarabine-based therapy.~   "
184827|NCT01145456|"~     This phase I trial is studying the side effects and best dose of gamma-secretase inhibitor~     RO4929097 when given together with gemcitabine hydrochloride in treating patients with~     advanced solid tumors. Gamma-secretase inhibitor RO4929097 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving gamma-secretase inhibitor~     RO4929097 together with gemcitabine hydrochloride may kill more tumor cells.~   "
184828|NCT01145443|"~     The care of critically ill patients in Intensive Care Units (ICUs) is an important part of~     modern health care systems. However, ICU care suffers from similar problems as the rest of~     the health care system. Powerful arguments support the concept that most of problems in~     complex systems, such as ICUs, relates to flaws in institutional systems and processes that~     hinder the ability of individuals to perform their jobs well. To fix these problems, the~     defective systems and processes must be redesigned in ways that make it easy for people to do~     their job well, and hard to make mistakes. Altering the structure of ICU care for the purpose~     of improving ICU performance is an example of Organizational Systems Engineering,~     alternatively called Total Quality Management.~      Another serious problem in ICU care is that after 2007 there will be a increasing shortage of~     physicians specializing in the care of the critically ill (Intensivists), with a 35%~     shortfall by 2030. One contributor to this shortage is that Intensivists retire at a younger~     age than do physicians in general, and often curtail their care of critically ill patients~     even before they retire. It is likely that the emotional and physical demands of this career~     choice leads Intensivists to burn out and leave the field prematurely. For these reasons it~     is important to find ways to make working as an Intensivist more sustainable so that the most~     experienced practitioners will continue in the field up to a normal retirement age.~      The way in which groups of Intensivists organize themselves to provide care in an ICU is~     highly variable. One potentially important way in which Intensivist staffing differs is in~     the degree of continuity of care. The more days in a row that the same physician cares for a~     patient the greater the continuity of care. While it is generally held that a higher~     continuity of care results in better care and better outcomes for patients, in fact there are~     no studies addressing this issue. On the other side of the coin however, it seems likely that~     working many days in a row increases the physical and emotional burdens on the Intensivist,~     increasing job distress and job burnout over time.~      A common pattern of Intensivist staffing, in which continuity of care is reduced, is when the~     Intensivist who is caring for ICU patients during the weekdays has the weekend off, during~     which one of his/her partners provides cross-coverage. While it is reasonable to~     hypothesize that cross-coverage would lead to inefficient patient care, at the same time it~     may reduce the burdens on the Intensivists.~      This purpose of this study is to investigate the effects of weekend cross-coverage on both~     ICU patients and on Intensivists. This will be a multicenter study performed in 4 member~     institutions of the Midwest Critical Care Consortium: The University of Toledo, MetroHealth~     Medical Center, Ohio State University, and Indiana University. Five adult medical ICUs from~     the six institutions will participate in this study, with two ICUs from the Ohio State~     University site.~      To answer the research questions, each participating ICU will alternate between two common~     models of Intensivist staffing. In both models an Intensivist is responsible for ICU care for~     14 days. In the Continuous model, a single Intensivist will be responsible for all 14 days.~     In the Discontinuous model, both weekends during the 14 days will be cross-covered by a~     colleague. Continuity of care is higher in the Continuous model, which has 2 physician~     transitions over a 4 week period, while the Discontinuous model has 8 transitions per 4~     weeks. Each participating ICU will use one model for 12 weeks, then switch to the other model~     for 12 weeks, and finally revert back to the first model for the final 12 weeks of this 36~     week study. To address problems of historical controls, seasonal differences, and to increase~     comparability of groups, the participating ICUs have been randomly assigned to begin the~     study either with the Continuous or Discontinuous model.~      Comparisons will be made between the two scheduling models in: (1) patient outcomes,~     specifically hospital mortality rate, ICU length of stay, and hospital length of stay, and~     (2) Intensivist outcomes, specifically job distress, job burnout, and the balance between~     work and home life.~      Since there is currently nothing known about whether weekend cross-coverage influences~     medical care, both models of care are common in ICUs. Thus the investigators expect that the~     findings of this study will have general relevance. While the patients admitted to the~     participating ICUs during this study would not be expected to benefit from this~     investigation, the results derived are expected to enable policy makers to make~     evidence-based decisions about this important aspect of ICU physician staffing and thus~     improve the performance and/or cost-effectiveness of ICU care, benefiting future ICU~     patients, and society.~   "
184829|NCT01145430|"~     This phase I trial studies the side effects and the best dose of veliparib when given~     together with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian~     cancer, fallopian tube cancer, or primary peritoneal cancer that has come back after a period~     of improvement, or breast cancer that has spread to other parts of the body. Veliparib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as liposomal doxorubicin hydrochloride, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving veliparib together with liposomal doxorubicin~     hydrochloride may kill more tumor cells.~   "
184830|NCT01145417|"~     This study examines the safety of pregabalin over a 6 month period in patients with~     neuropathic pain associated with HIV infection as an extension of another trial that tests~     the efficacy of pregabalin.~   "
184883|NCT01144715|"~     The purpose of this research is to evaluate a therapy delivery system for stroke patients~     that provide accessible, affordable stroke care. User-friendly home therapy robots and a~     telerehabilitation system are combined to monitor and provide therapy that is accessible for~     patients in rural and underserved locations. The robotic-based home therapy intervention will~     produce significantly greater improvement in upper extremity motor function than Usual and~     Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation~     program at the end of 8 weeks of home therapy.~   "
184831|NCT01145404|"~     Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a~     beneficial contribution to current treatment paradigms since preclinical data suggest that~     lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines,~     which may contribute to clinical benefit. The study described in this protocol has been~     designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in~     the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to~     search for molecular correlates that may be associated with response to this compound.~      The majority of patients with metastatic gastric and gastro-esophageal cancer undergo~     first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes~     combined to a taxane), but the role of second-line chemotherapy has not yet been defined.~     Therefore, progression during or shortly after first-line chemotherapy is a medical condition~     no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and~     gastroesophageal cancer make these indications prime candidate for treatment with the dual~     ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.~   "
184832|NCT01145391|"~     The goal of this project is to use health information technology and team-based care in novel~     ways to support the establishment of a Patient-Centered Medical Home model of care aimed at~     improving the diagnosis and management of hypertension. Compared with patients who receive~     usual care, patients who receive intervention will have a lower average systolic blood~     pressure 9 months after randomization.~   "
184833|NCT01145365|"~     This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas~     and abscesses prior to starting medical therapy.~   "
184834|NCT01145352|"~     This surveillance is conducted to survey the followings under the post marketed drug~     utilization on the patients who are administrated ENBREL as a treatment for active~     polyarticular JIA.~        1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious~          adverse events~        2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.~   "
184835|NCT01145339|"~     The study primary objective is to compare the clinical efficacy of two formulations in the~     supportive treatment of lactose intolerance.~   "
184836|NCT01145326|"~     The purpose of this study is to determine whether co-application of a functional microarray~     of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is~     to determine whether the depth of anesthesia is enhanced.~   "
184837|NCT01145313|"~     The primary objective is to examine changes in pre/post-augmentation healthcare costs and~     resource utilization in patients diagnosed with major depressive disorder (MDD) who augment~     their current antidepressant therapy with an atypical antipsychotic.~   "
184838|NCT01145300|"~     Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and~     mortality worldwide and is characterized by fixed airflow obstruction. The cornerstone of the~     disease is chronic inflammation leading to narrowing of the small airways and thus impairment~     of lung function. Compared to spirometry, the single breath N2-washout-test is more sensitive~     to identify the regional heterogeneity of bronchial airflow obstruction in the small airways.~      The aim of this study is to evaluate whether there is a correlation between the sbN2-test,~     markers in exhaled air and the inflammatory cells in the small airways.~   "
184839|NCT01145287|"~     The main purpose of this study is to assess the impact of the diagnosis of celiac disease on~     general health, healthcare resource utilization, quality of life and lifestyle. We~     hypothesize that diagnosis and subsequent dietary treatment may have positive impact on these~     variables.~   "
184840|NCT01145274|"~     To know the blood level of allopurinol in chronic kidney disease (CKD) patient.~   "
184841|NCT01145261|"~     The current study will focus on two phases of anxiety process: Generating Anxiety (reported,~     direct and physiological) and Emotional Regulation Strategies (Reappraisal, Mindfulness,~     Expressive Suppression and Rumination). The claim is that better understanding of these~     phases in relation to CBT treatment will lead to better understanding of remission in anxiety~     and to better treatments in the future. Objectives: To understand the relations between the~     four strategies of emotional regulation to anxiety disorder hence to understand the relation~     between these strategies to treatment effectiveness of children with anxiety disorder.~     Methods: In phase one, clinically anxious adolescence before treatment (N=40) and healthy~     controls (N=40) will be compared. Anxious adolescence are expected to have significantly~     higher levels of physical arousal and will use spontaneously more expressive suppression and~     rumination and less reappraisal and mindfulness then the healthy controls. In phase two,~     clinically anxious adolescence (N=40) before and after 8-12 weeks of CBT treatment will be~     compared. More specifically remitted patients will be compared with partially remitted~     patients. Remitted patients are expected to show better improvement in the physical arousal,~     then partially remitted. More, Decrease in levels of anxiety will be mediated by the four~     emotional regulation strategies, and the efficiency of using the Reappraisal will be higher.~   "
184842|NCT01145248|"~     Cholangiocarcinomas (CCCs) are malignant tumors arising from the biliary epithelium. CCCs are~     characterised by a high mortality and the only curable therapy is complete tumor resection,~     if feasible, or in some cases liver transplantation. Since surgery for CCC is a procedure~     associated with a high mortality itself it needs to be ascertained that an accurate~     preoperative diagnosis has been established. However, it often appears to be difficult to get~     a preoperative pathological diagnosis, since it is difficult to obtain tumor specimens using~     cytologic brushings, biopsy forceps, bile aspiration or endoscopic ultrasonography~     guided-fine needle aspiration. This is reflected by a nearly 100% specificity but low~     sensitivity rates.~      The aim of this study is to compare a new method of biliary biopsy using a double-balloon~     enteroscopy (DBE) forceps to enable a safe and reliable tissue specimen collection within the~     proximal biliary tract with cytology brushings in patients with suspected malignant proximal~     biliary strictures.~   "
184843|NCT01145235|"~     A Registry to monitor long term safety in female subjects after treatment with Macrolane~     VRF20 and/or MacrolaneT VRF30 in the breasts.~   "
184844|NCT01145222|"~     The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056~     compared with midazolam to maintain suitable sedation levels in patients undergoing~     colonoscopy.~   "
191787|NCT01053975|"~     The purpose of this study is to validate the accuracy of the SPIROCOR System in indicating~     the presence of significant coronary artery disease (S-CAD), as defined in ACC/AHA~     Guidelines, in subjects with suspected S-CAD.~   "
184845|NCT01145209|"~     Background:~      - Ofatumumab has been approved by the U.S. Food and Drug Administration to treat patients~     with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not~     responded to standard chemotherapy. Ofatumumab is a substance that recognizes specific types~     of white blood cells called B-lymphocytes, which become cancerous in CLL/SLL. Ofatumumab~     attaches to a molecule called CD20, which is found on the surface of B-cells, and destroys~     them. Previous studies have shown that ofatumumab can decrease the number of B-cells in~     patients with CLL/SLL who have been treated with chemotherapy, but more research is needed to~     determine it if can also be used to treat patients with previously untreated CLL/SLL.~      Objectives:~      - To determine a safe and effective dose of ofatumumab, along with chemotherapy, to treat~     chronic lymphocytic leukemia or small lymphocytic lymphoma.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with CLL or SLL that has not~     been treated with chemotherapy.~      Design:~        -  Eligible participants will be screened with a physical examination, blood samples, lymph~          node and bone marrow biopsies, and imaging studies.~        -  Participants will be separated into two groups: all participants will receive ofatumumab~          and fludarabine, and some participants will be selected to also receive cyclophosphamide~          (based on the results of certain blood tests).~        -  Participants will receive the study drugs (ofatumumab and fludarabine, and optional~          cyclophosphamide) by infusion for a maximum of 6 days, followed by 21 days off the drug.~        -  Participants will have six cycles of treatment according to a schedule set by the study~          doctors, and may have their dose levels adjusted if side effects develop.~        -  Participants who have disease remaining after six cycles will receive additional~          ofatumumab every 2 months, starting 2 months after the end of the sixth cycle and~          continuing for a total of four doses, before entering the follow-up phase of the trial.~          Participants who do not have residual disease after six cycles will not receive~          additional therapy, and will immediately enter the follow-up phase of the trial.~        -  Participants will have a follow-up exam every 2 to 4 months for 2 years after the end of~          treatment, and then as required by the study doctors for as long as the study remains~          open. These visits will involve a full medical examination, blood samples, lymph node~          and bone marrow biopsies, and imaging studies.~   "
184846|NCT01145196|"~     Background:~      - Plaquenil (hydroxychloroquine) is an anti-inflammatory drug that is used to treat some~     autoimmune diseases such as lupus and rheumatoid arthritis. This drug can damage the retina~     by causing a condition called plaquenil-induced retinal toxicity, which may lead to vision~     loss. However, most people taking plaquenil do not develop this problem. Researchers are~     interested in studying whether differences in a person s genes explain why some people~     develop plaquenil-induced retinal toxicity while others do not.~      Objectives:~      - To investigate possible correlations between certain genes or genetic mutations and~     plaquenil-induced retinal toxicity.~      Eligibility:~        -  Individuals at least 18 years of age who have previously used plaquenil.~        -  Both individuals who have and have not developed plaquenil-induced retinal toxicity will~          be eligible for this study.~      Design:~        -  The study requires one or two visits to the National Eye Institute or an outpatient~          study clinic over a maximum 2-year period.~        -  Participants will provide a personal and family medical history, and will have a full~          eye examination.~        -  Participants will also provide blood samples for testing.~        -  No treatment will be provided as part of this protocol.~   "
184847|NCT01145183|"~     Doxazosin, an alpha 1-adrenergic receptor antagonist, may play an important role in cocaine~     addiction in humans. This study will evaluate to what extent the prospective screening for~     catecholamine related polymorphisms for alpha 1 NE receptor/transporter, COMT and DBH as main~     targets predict the treatment efficacy of doxazosin for cocaine-using behavior.~   "
184848|NCT01145170|"~     The study consists in only one treatment group, which will receive the first-line therapy for~     the disease - standard radiotherapy and a 150 mg/m2 dose of the investigational product~     (nimotuzumab)~   "
184849|NCT01145157|"~     This is a prospective, randomised clinical outcomes study comparing the Signature~     Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted~     Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and~     efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and~     Computer Assisted Navigation.~   "
184850|NCT01145144|"~     The aim of this study was to evaluate the effect of dehydroepiandrosterone supplementation on~     in vitro fertilization performance and outcome among poor-responder patient.~   "
184851|NCT01145131|"~     Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is~     to test whether meat structure plays an important role in protein digestion, to maximise the~     amino acid availability and to stimulate the muscle protein growth in elderly people.~   "
184852|NCT01145118|"~     Plantar Fasciitis (PF) is the most common foot condition treated by healthcare providers,~     striking approximately 2 million Americans each year. Nevertheless its causes are still not~     known. The risk factors for PF are known and the diagnosis, which is based on clinical~     assessment, is relatively simple. Still most of the treatments for PF focus on short term~     symptoms relief instead of prevention or reduction of recurrence.~      Physical therapy treatment that focuses on reducing the symptoms for the long run and~     prevention, should include outcome measures, which if found to be reliable, will make the~     diagnosis clearer. Diagnosis based on reliable clinical and functional measures will assist~     the physical therapist to understand the major deficiencies of the patient, and accordingly~     to help him to make the right decision in choosing treatment. Also comprehensive knowledge of~     the characteristics of PF may enable selection of appropriate preventive measures.~   "
184853|NCT01145105|"~     Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the~     population during the course of their life . The majority of LBP is resolved within 3 months;~     however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with~     sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or~     without low back pain.~      It has been shown in the upper limb that by positioning the contra-lateral arm in tension the~     investigators actually reduce tension in the ipsilateral arm. Patients, who present with~     symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that~     reduces tension through the contra-lateral leg.~      Working Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics~     techniques will result in better rehabilitation of individuals with radicular LBP.~   "
184884|NCT01144702|"~     The purpose of this study was to evaluate the effectiveness of the fixed combination of~     artesunate+mefloquine in the treatment of uncomplicated malaria caused by Plasmodium~     falciparum in the municipality of Cruzeiro do Sul, Juruá Valley, Brazil, where it was being~     used as specific first-line drug.~   "
184885|NCT01144689|"~     The purpose of this study is to assess the effects of mindfulness training (MT) compared to~     standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in~     individuals trying to quit smoking.~   "
184886|NCT01144676|"~     The proposed study is a single-center, double-blind, randomised, placebo-controlled trial to~     evaluate the delivery of dapivirine from matrix vaginal rings over a 56 and 57 day period and~     to assess the safety as compared to placebo vaginal rings in 48 healthy, HIV-negative,~     sexually active women.~   "
184854|NCT01145092|"~     Life style intervention including diet and exercise is the recommended strategy for~     prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2~     diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of~     developing type 2 diabetes of 40%- 80%. Poor physical fitness is a strong indicator of an~     increased risk of developing diabetes.~      Long-term endurance exercise training has been shown to increase insulin sensitivity in~     sedentary young and elderly individuals, first degree relatives of patients with Type 2~     diabetes, glucose intolerant obese, or Type 2 diabetic humans. In type 2 diabetic patients,~     non-diabetic individuals with IGT and sedentary adults after exercise training of different~     intensity, different duration and different frequency an increase of insulin sensitivity was~     found.~      However, despite the vast knowledge concerning beneficial effects physical activity for the~     prevention of T2DM (and many other chronic metabolic disorders) to date wide ranging~     strategies have not been realized satisfactory. Regardless of age, ethnicity, sex or health~     status the lack of time is the primary reason for the failure to exercise on a regular basis~     (or is stated as primary reason). Therefore the investigators aimed at investigating whether~     a controlled endurance/resistance training twice a week over 6 month might be beneficial for~     healthy, non obese, first degree relatives with T2DM. Therefore the investigators measure~     parameters associated with the prevention of T2DM like insulin sensitivity, flux through~     fATPase and fCK, intramyocellular and hepatocellular lipids.~   "
184855|NCT01145079|"~     Drug-eluting stents (DES), markedly reducing the neointimal hyperplasia after stent~     implantation compared with bare-metal stents (BMS), have improved angiographic and clinical~     outcomes in the complex lesions and patients with high risks. However, currently, the fatal~     events related with stent thrombosis still occur and are the major limitation of the use of~     DES. Especially, late or very late thrombosis after DES implantation is an uncommon but~     life-threatening fatal complication presented with sudden death or myocardial infarction (MI)~     causing heart failure. The most powerful predictor for stent thrombosis is the~     discontinuation of clopidogrel. In consideration of current data regarding stent thrombosis~     and clinical situation of discontinuation of antiplatelet, zotarolimus-eluting stent (ZES)~     [Endeavor®, Medtronic Vascular, Santa Rosa, CA] might be anticipated to be safer than other~     DES during the long-term follow-up owing to healthy endothelialization. Endeavor® stent was~     consists of zotarolimus, thin-strut, cobalt-chromium alloy stent platform (DriverTM stent;~     Medtronic Vascular, Santa Rosa, CA), and phosphorylcholine coating. The ENDEAVOR II study~     demonstrated clinically and statistically significant improvement in all of study endpoints,~     including a 47 percent reduction in the primary endpoint of target vessel failure (TVF). In~     addition, the ENDEAVOR II trial showed a 0.5 percent rate of stent thrombosis at 30 days -~     with no late thrombosis beyond 30 days and no late stent malapposition. Because~     reendothelialization after ZES implantation may occur within 3 months, 3-month dual~     antiplatelet therapy is recommended in many clinical trials and real world practice. Shorter~     maintenance of dual antiplatelet therapy might minimize the risk for stent thrombosis in~     cases of discontinuation of antiplatelet and prevent waste medications and bleeding~     complications related with dual antiplatelet therapy. However, there have been no~     non-inferior or superior data of ZES considering all these circumstances. Therefore, the~     investigators hypothesize that ZES with 3-month dual antiplatelet therapy may be safe and~     beneficial in patients with coronary artery disease during follow-up than other DES, in spite~     of higher late lumen loss. To test this hypothesis, the investigators will perform a~     multi-center, randomized, prospective trial aimed at demonstrating the efficacy of the ZES~     versus other DES in patients with coronary artery disease in real world practice.~   "
184856|NCT01145066|"~     This study will compare how well a combination of borage and echium oils will reduce~     inflammation compared to fish oils and placebo oil in subjects that are diabetic or have~     metabolic syndrome.~   "
184857|NCT01145053|"~     To investigate safety and effectiveness information on the use of Tiotropium Respimat for~     long time of period in daily practical clinical circumstances, and to obtain proper drug use~     information.~   "
184858|NCT01145040|"~     The NOMOTHETICOS study is a unicentric cross-sectional study for a quantitative analysis of~     feedback-inhibition in the thyrotropic homeostatic control. Structural parameters are~     obtained in vivo from open-loop analysis in patients with disconnected feedback, i.e. with~     overt thyroid dysfunction or full dose substitution therapy with levothyroxine.~   "
184859|NCT01145027|"~     Forty healthy volunteers will undergo two nailfold-videocapillaroscopy exams with a 10-minute~     interval between them, after an 10-h overnight fast in a temperature controlled room. The~     subjects will be randomized in two groups: one will receive a sensorial stimulus during the~     interval (stimulus group - SG) and the other will receive no stimulus (control group - CG).~     The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma,~     composed by favorite food items previously related by the individual for this meal. The meal~     will not be offered for immediate intake, it will be placed in front of the volunteer for~     perception of the smell and taste.~      Baseline microvascular parameters will be compared to the results after the interval. The~     investigators hypothesize that the SG will have greater capillary recruitment due to a~     possible effect of physiologically secreted insulin provoked by the sensorial stimulation~     (cephalic phase of insulin secretion).~   "
184860|NCT01145014|"~     As a transition from preclinical investigations to clinical development in this~     first-in-human trial, safety, tolerability, and pharmacokinetics of BI 660848 will be~     assessed in human male volunteers using single rising oral doses in order to provide the~     basis for a potential ongoing clinical development of BI 660848 in the indication of~     neuropathic pain.~   "
184861|NCT01145001|"~     The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement~     therapy when used in combination with the contingency management (CM) + cognitive behavioral~     therapy intervention. Subjects will be randomly assigned to receive either a nicotine~     transdermal patch or a placebo patch as well as being randomly assigned to receive either CM~     or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that~     subjects receiving both active nicotine patch and CM will have higher rates of abstinence~     from tobacco than subjects in the other groups.~   "
184887|NCT01144663|"~     The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate~     vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2~     months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be~     co-administered.~   "
184888|NCT01144650|"~     The main purpose of the study is to get information about the safety and efficacy of~     treatment with Dapsone to prevent the disability after ischemic Stroke, in patients diagnosed~     with anterior territory brain infarct.~   "
184889|NCT01144637|"~     A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and~     safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in~     healthy, vaccinia-naïve subjects.~   "
184956|NCT01143753|"~     This open-label, multi-center study will evaluate the safety, tolerability, and~     pharmacokinetics of RO5212054 [PLX3603] in participants with BRAF V600-mutated advanced solid~     tumors. Cohorts of participants will receive escalating oral doses of RO5212054. Anticipated~     time on study treatment is until disease progression or unacceptable toxicity occurs.~   "
184862|NCT01144988|"~     Malignant glioma are the most common and aggressive primary brain tumors in adults. Despite~     advances in multimodal treatment including surgery, radiation and chemotherapy, most patients~     have a dismal prognosis of 9-15 months (Stupp et al., NEJM 2005).~      A major reason for the aggressiveness of malignant glioma is a pronounced tumor~     neovascularization, mainly driven by the vascular endothelial growth factor (VEGF) and its~     receptors. The therapeutic monoclonal antibody Bevacizumab (Avastin®) inhibits the VEGF~     pathway by binding the VEGF ligand. In Magnetic Resonance Imaging (MRI) this treatment~     reduces contrast enhancement by restoring both, the blood-brain-barrier and the destabilized~     vessel integrity. Furthermore, it raises the sensitivity of co-administered chemotherapeutics~     such as Irinotecan. In conclusion, anti-angiogenic therapy leads to the problem that the~     routinely used MRI techniques cannot distinguish anti-vascular effects from true anti-tumor~     effects.~      The study hypothesis of the clinical trial part is that in 35% of malignant glioma patients~     Avastin / Irinotecan chemotherapy results in objective tumor responses assessed by standard /~     functional MRI and FET- /FLT-PET neuroimaging. The study hypothesis for the translational~     study part is that the expression of the molecular targets of Avastin and Irinotecan in~     malignant glioma tissue ( = tumor and vascular cells) are predictive for Avastin / Irinotecan~     therapy induced treatment response measured by functional MRI and FET- / FLT-PET imaging.~   "
184863|NCT01144975|"~     The study hypothesis is that XOMA 052 is likely to improve glycemic control in subjects with~     Type 2 Diabetes Mellitus.~      The purpose of this study is to determine whether XOMA 052 improves glycemic control in~     subjects on Metformin monotherapy whose diabetes is still not adequately controlled.~   "
184864|NCT01144962|"~     In a dose escalation study we will determine the safety and preliminary efficacy of~     allogeneic bone marrow mesenchymal stem cells (bmMSCs) in the induction of response for~     active fistulizing Crohn's Disease (CD).~   "
184865|NCT01144949|"~     The purpose of this study is to assess if patients treated with silodosin will have a higher~     spontaneous passage rate of their ureteral stone than those treated with placebo.~   "
184866|NCT01144936|"~     The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV~     subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of~     VX-985.~   "
184867|NCT01144923|"~     The main objective of this study is to determine whether interventional treatment (i.e.~     epidural steroids), conservative therapy, or the combination, is superior for cervical~     radiculopathy. One hundred and sixty eight patients with radicular neck pain will be~     randomized in a 1:1:1 ratio to receive either cervical epidural steroid injections (CESI),~     non-interventional management with physical therapy and medications, or a combination of the~     two. The first follow-up visit will be at 1-month. In patients who obtain some benefit but~     continue to report significant pain, either a 2nd CESI can be done, the patient's medications~     can be adjusted, or both in the combination group. Those patients who fail to obtain any~     benefit will exit the study to receive another treatment or alternative care. The second~     follow-up visit will be at 3-months. Similar to the 1-month follow-up, the doctor may elect~     to change nothing in patients who are satisfied, adjust medications, schedule the patient for~     another CESI, or do both in the combination group. Patients who fail to obtain any benefit~     can exit the study to receive alternative treatment. The final follow-up visit will be at 6~     months.~   "
184868|NCT01144910|"~     The aim of investigator´s clinical trial is to investigate 52 patients aged three to five~     years with viral-induced asthma and 52 patients aged three to five years with allergic~     asthma. Over a time-span of 5 years the investigators will explore lung function and~     bronchial responsiveness. The investigators plan to evaluate long-term clinical history of~     moderate to severe bronchial hyperresponsiveness in preschool children with asthma. Therefore~     factors like atopy in children, parental atopy and bronchial hyperresponsiveness will be~     explored.~   "
184869|NCT01144897|"~     One purpose of this research study is to examine if a special type of imaging test, a~     positron emission tomography (PET) scan using the radioactive material [C-11] acetate, will~     be helpful in detecting prostate cancer lesions in subjects with castrate-resistant prostate~     cancer. This PET scan will be combined with a computed tomography (CT) scan taken during the~     same imaging session. The other purpose of the PET-CT scan using [C-11] acetate (PET Acetate~     Scan) is to assist in identifying who is responding to the treatment (docetaxel~     chemotherapy).~   "
184870|NCT01144884|"~     The annual incidence of neck pain has been reported to be 14.6%. Other studies outline a wide~     disparity in the lifetime incidence of neck pain ranging from 22% to 70%. Numerous treatment~     options exist for the management of neck pain however, there is limited evidence to support~     which interventions are most effective. Exercise based interventions are commonly used in the~     treatment of patients with neck pain however; it is not clear which patients are most likely~     to benefit from this type of treatment. The purpose of this project is to develop a clinical~     prediction rule (CPR) to identify which patients with neck pain have a greater probability of~     benefiting from a standardized program of education and exercise. Ninety (90) patients~     referred to physical therapy will undergo a standardized examination to assess potential~     predictor variables. Upon completion of the examination a standardized treatment program of~     education and exercise will be administered regardless of examination findings. Self report~     measures will be administered on the initial examination and on follow up visits at 2, 4, and~     6 weeks. A questionnaire and outcome measures will be also mailed out 6 months after~     initiation of treatment to assess long-term change. Once the treatment plan is completed,~     patients will be classified as having either a successful or non-successful response.~     Subjects which rated their perceived recovery on the Global Rating of Chance (GROC) as a~     very great deal better, a great deal better, quite a bit better, or moderately better~     (i.e., a score of +4 or greater) will be categorized as having a successful outcome. The~     primary endpoints to determine the outcome will be analyzed at 6 weeks and 6 months. The~     result of this study will assist physical therapists to identify sub-groups of patients~     likely to benefit from a program of education and exercise. The categorization of patients in~     groups based on beneficial treatments may help to provide improved outcomes.~   "
184871|NCT01144871|"~     This study will provide new and important information regarding parental knowledge and~     attitudes of confidential STI and related health care services (prevention, diagnosis and~     treatment) for teens that may be needed to address the STI epidemic. Using both qualitative~     and quantitative methods, this study will gather information necessary to develop effective~     interventions aimed at the often neglected parent component of the teen-parent-health care~     provider partnership by giving parents knowledge and skills to help them facilitate their~     adolescent's access to confidential STI services as needed.~   "
184872|NCT01144858|"~     The purpose of this study was to determine whether left atrial appendage flow velocity, as~     determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter~     ablation of persistent Atrial fibrillation( pAF).~   "
184918|NCT01144260|"~     A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic~     Lymphocytic Leukemia (B-CLL).~   "
184873|NCT01144845|"~     Pain that persists after the healing of a surgical wound has previously been described as an~     important, but often unrecognized clinical problem. Persistent postsurgical (chronic~     postoperative pain) is the consequence of either ongoing inflammation or more common~     neuropathic pain as a result of surgical damage to peripheral nerves.~      Previous studies have shown that chronic pain is a frequent and serious complication~     following thoracic surgery. However, the prevalence of chronic pain following both~     thoracoscopy and anterior thoracotomy in patients with pulmonary malignancies is poorly~     characterized and the impact of this pain on patients' lives remains unclear. Thus, this~     study aims to investigate the prevalence of chronic pain following thoracoscopy or anterior~     thoracotomy, and the severity and impact of persistent post-surgical pain on daily life.~      This study is working with several hypotheses: 1.) persistent postsurgical pain following~     lung cancer surgery is predominantly of neuropathic nature and the presence of neuropathic~     symptoms increases the severity of postsurgical pain and reduces the patient's quality of~     life, 2.) the prevalence of chronic pain is reduced over time, and 3.) less invasive thoracic~     surgical interventions reduces the risk of the development of chronic pain.~   "
184874|NCT01144832|"~     Purpose:~      To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the~     H1-receptor antagonist ebastine.~      Design:~      Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment~     with ebastine 20mg once daily or placebo (1:1 randomization).~      End points:~      End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which~     will be evaluated with a barostat test.~   "
184875|NCT01144819|"~     Background:~      Dual antithrombotic treatment with aspirin and clopidogrel is recommended in patients with ST~     elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention~     (PCI). The European Society of Cardiology (ESC) Guidelines recommend a bolus dose of aspirin~     of 250-500 mg and a 600 mg bolus dose of clopidogrel as soon as STEMI is suspected. Studies~     have shown that more newly produced platelets are present in the acute phase of STEMI, and it~     is likely that these immature platelets are haemostatically more active and might be of~     importance in thrombus formation.~      The enhanced platelet reactivity may reduce the effect of aspirin and clopidogrel in the~     acute phase of STEMI compared to measurements made in the same patients 3 months after~     primary PCI.~      Aim:~      This study aims to compare platelet response to aspirin and clopidogrel in the acute phase of~     STEMI with the platelet response in the same patients 3 months after STEMI .~      Design:~      This study is an observational follow-up study.~      Materials and methods:~      46 patients with STEMI referred to primary PCI at Aarhus University Hospital, Skejby will be~     included in the study. A total of 3 blood samples are obtained in the acute phase of STEMI:~     Prior to primary PCI (Blood sample 1), at 4 hours (Blood sample 2) and at 12 hours (Blood~     sample 3) after administration of loading dose aspirin and clopidogrel. When patients are in~     a stable phase 3 month later, a final blood sample is taken (Blood sample 4). The blood is~     analyzed 30 minutes after withdrawal of blood by the platelet aggregation test Multiplate®~     aggregometry (agonists: Collagen, arachidonic acid and adenosinediphosphate) and VerifyNow®~     arachidonic acid and P2Y12 aggregometry. Platelet count, volume and the immature platelet~     fraction (IPF) will be measured using Sysmex® flowcytometry.~   "
184876|NCT01144806|"~     This project is being conducted with an aim to find out energy expenditure, body composition~     and recovery rates in children with severe acute malnutrition (SAM) receiving community-based~     nutritional rehabilitation therapy~   "
184877|NCT01144793|"~     The purpose of this study is to measure, in pilot/observational study, panels of circulating~     proteins in real time at the onset of neutropenic fever/infection in patients with acute or~     chronic leukemias undergoing chemotherapy or other biologic treatment. And to generate~     preliminary trend results in panels of circulating proteins longitudinally during the period~     of neutropenia and to correlate those values to clinical/laboratory data and patient~     outcomes.~   "
184878|NCT01144780|"~     The objective of this study is to better understand the underlying pathogenetic mechanisms of~     MPDs. We will collect peripheral blood samples from MPD patients and utilize multiparameter~     phospho-specific flow cytometry to investigate dysregulated signaling in blood cells from~     these patients. This will provide deeper insights into the pathogenesis of MPDs and may lead~     to the identification of novel targets for therapeutic intervention.~   "
184879|NCT01144767|"~     Despite the recognized health benefits of a physically active lifestyle, mid-life and older~     low-income and ethnic minority adults, including Hispanic Americans, are among the least~     active and understudied groups in the U.S. This research aims to develop and evaluate a~     bi-lingual physical activity promotion program, applying easy to use state-of-the-art~     computer technology, which is tailored to the preferences and needs of mid-life and older~     Latino adults. Such computer-based programs represent a potentially low-cost means for~     reaching the large proportion of low-income and ethnic minority Americans who are~     under-active.~   "
184880|NCT01144754|"~     This is a multi-center observational study to assess addition of Rituximab in the treatment~     of previously untreated patients with Diffuse Large B-Cell Lymphomas(DLBCL) over an~     enrollment period of 60 months. Patients in this study are enrolling for the collection of~     their data on observations made during normal clinical practice.~   "
184881|NCT01144741|"~     Freeman-Sheldon syndrome (FSS) is a rare muscle disorder present before birth, involving~     primarily problems of the face and skull and the hands and feet.~      This is a study of problems, experiences, helpful treatments, and quality of life focusing on~     patients with FSS but including patients with Sheldon-Hall syndrome (SHS), distal~     arthrogryposis type 1 (DA1), and distal arthrogryposis type 3 (DA3), also called Gorden~     syndrome. These and related disorders are very challenging to treat, partly because the big~     differences in individual patients and lack of information on previous clinical experience~     with treatment options. It is hoped the study will identify areas for further research in~     physiology and therapy.~      This study will cover all types of treatment [medical (non-surgical), including psychiatric,~     and surgical treatments], even unconventional. It also includes questions about effects on~     the patient's thoughts, feelings, quality of life, and relationship with siblings, family,~     and parents' and if any intervention was required or advised. This study will also look for~     similarities and differences in patients who meet the head and face part of the diagnostic~     criteria but do not meet all other parts and patients who met the full diagnostic criteria.~     There will be questions about problems or experiences to investigate if both groups of~     patients may have the same syndrome. Treatment success depends on getting a correct~     diagnosis.~   "
184882|NCT01144728|"~     Primary Objective:~        -  To describe the conditions of initiation and titration of Amaryl M, according to~          previous treatment:~        -  initial dose~        -  titration scheme~        -  efficacy after 4 months assessed by HbA1C~        -  tolerability (number and severity of hypoglycaemia)~      Secondary Objective:~        -  Fasting Plasma Glucose~        -  Weight evolution~   "
184890|NCT01144624|"~     The two co-primary objectives of this study are to assess in Japanese patients with severe~     sepsis and/or septic shock: 1) the safety and tolerability of two different doses of~     intravenous AZD9773 and 2) the PK of AZD9773.~      The secondary objective is to make a preliminary assessment of the pharmacodynamics of two~     different doses of intravenous AZD9773 in Japanese patients with severe sepsis and/or septic~     shock.~   "
184891|NCT01144611|"~     This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed~     to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in~     reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions~     in patients undergoing invasive cardiac surgery: combined aortic valve replacement and~     coronary artery bypass grafting.~   "
184892|NCT01144598|"~     The objective is to measure time delay from onset of symptoms to diagnosis and time to~     disease-modifying anti-rheumatic drug treatments in Turkish patients with rheumatoid~     arthritis. The investigators will also evaluate actual work limitation status of patients and~     impact of demographic and clinical factors on work limitations in rheumatoid arthritis~     patients.~   "
184893|NCT01144585|"~     Remote Ischemic Preconditioning(RIPC) and remote ischemic postconditioning(RIPoC) seems to~     have a protective effect during ischemic period. Using cardiopulmonary bypass(CPB) during~     open heart surgery reduces pulmonary blood flow and may cause ischemic damage to lung tissue.~     The investigators anticipate that RIPC and RIPoC may reduce lung injury after CPB.~   "
184894|NCT01144572|"~     The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC~     patients during adjuvant AIs treatment in terms of: the change of the trial outcome index~     (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit~     approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR~     (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.~   "
184895|NCT01144559|"~     This is a research study to determine if the way local anesthetic- or numbing medication- is~     delivered through a tiny tube next to the nerves that go to the thigh affects the strength~     and sensation in the thigh.~   "
184896|NCT01144546|"~     Hypotension frequently occurs during anesthesia induction. Preload decrease by anesthetics~     was often considered as one of main causes for this hypotension. However, the studies on this~     topic have been lacking. Dynamic preload indices are more suitable than static preload~     indices to predict the effect of preload changes. And, recently, passive leg raising test~     showed successful results to predict fluid responsiveness in patient with spontaneous~     ventilation.~      The investigators hypothesized that hypotension after induction of anesthesia is caused by~     decrease of preload by anesthetics and passive leg raising test could predict this~     hypotension. In this study, the investigators will try to evaluate whether passive leg~     raising induced hemodynamic changes could predict hypotension during anesthesia induction.~   "
184897|NCT01144533|"~     The purpose of this study is to compare the efficacy of intra-articular steroid injection,~     sodium hyaluronate injection, a combination of the two, and placebo in the treatment of~     adhesive capsulitis of the shoulder.~   "
184898|NCT01144520|"~     The purpose of this study is to study impairment of white blood cell function in patients~     with type II diabetes.~   "
184899|NCT01144507|"~     The specific aims for this study are:~        1. To determine if sonographic findings predict the risk of progression of liver disease to~          cirrhosis by comparing cystic fibrosis subjects with heterogeneous echogenicity pattern~          on ultrasound to those with normal echogenicity pattern on ultrasound~        2. To develop a database and biorepository of serum, plasma, urine and DNA to aid the~          investigations in ascertaining the mechanisms, consequences, genetic risk factors and~          biomarkers for the development of cirrhosis~        3. To determine if there are differences in health related quality of life, pulmonary or~          nutritional status in children with cystic fibrosis who have a heterogeneous echo~          pattern on ultrasound compared to those who have a normal echo pattern on ultrasound~        4. To determine if Doppler velocity measurements of hepatic and splenic vessels predict an~          increased risk for the development of cirrhosis.~        5. To determine if cirrhosis on ultrasound progresses to portal hypertension during the~          study period~        6. To determine if homogeneous liver progresses to either cirrhosis or heterogeneous liver.~        7. To determine the frequency of complications of portal hypertension during follow up in~          those identified with cirrhosis by year 6 of the study~   "
184900|NCT01144494|"~     Investigate nocturnal effects on aqueous humor dynamics of a clinically used eye pressure~     -lowering drug, brimonidine, when given for six weeks.~   "
184901|NCT01144481|"~     Bone is the most common site of distant breast cancer recurrence, and 65-75% of women with~     advanced breast cancer will develop bone metastases during the course of their disease. The~     most pressing problem in management of bony metastases today, is the inability to reliably~     identify patients at high risk for skeletal related events (SREs) (such as bone fractures,~     surgery/radiotherapy for pain or prevention of fractures, high calcium levels, and spinal~     cord compression) despite the standard use of bone medication (bisphosphonates). Using the~     latest innovations both in imaging and blood tests, this novel pilot project will develop a~     risk model for predicting bone metastases, which will be able to identify patients who would~     most benefit from novel treatments, such as the multikinase inhibitor Zactima and the Src~     inhibitor, AZD0530. Given that approximately 1/3 of patients with metastatic breast cancer~     and bony disease will sustain an SRE despite use of a bisphosphonate, there is an urgent~     unmet need in this large population to introduce effective bone protective agents.~   "
184919|NCT01144247|"~     The purpose of this research study to determine if treating recurrent malignant gliomas with~     another person's (donor) immune system cells known as aCTL cells, will be safe. This study~     will also try to determine if persons who receive aCTL's are more or less likely to survive~     their brain tumor than persons who had similar tumors in the past. Approximately 15 patients~     will be enrolled at UCLA.~   "
184955|NCT01143766|"~     The standard approach to sedation in endoscopic retrograde cholangiopancreatography (ERCP)~     involves the use of benzodiazepines and opiates to achieve a moderate depth of sedation.~     There is data to suggest supplementing this regimen with gabapentin may lead to reduced pain,~     higher patient satisfaction and lower opiate requirements. The investigators are conducting a~     clinical trial to study this hypothesis.~   "
184902|NCT01144468|"~     The NCIC CTG was conducting an international breast cancer prevention trial (MAP.3) examining~     the effects of a new therapy (exemestane) for breast cancer prevention in postmenopausal~     women at increased risk of developing this disease. Results showed that after a median follow~     up of 35 months, exemestane was superior to placebo in breast cancer prevention. Exemestane~     blocks estrogen production, which may be beneficial for preventing breast cancer, but may~     have negative effects on bone. As postmenopausal women are at risk for developing~     osteoporosis, determining whether exemestane causes bones to weaken is crucial for women~     considering it for long-term use. Dr. Cheung's team followed the bone health of 354 women in~     MAP.3 in detail over 2 years and found that volumetric bone mineral density (by high~     resolution peripheral quantitative computer tomography (HR-pQCT) at the radius and tibia as~     well as areal bone mineral density by dual energy x-ray absorptiometry (DXA) at the hip and~     spine decreased significantly with the use of exemestane. The long term effects of exemestane~     on bone will be examined up to 5 years of therapy and then 2 years post therapy to delineate~     the effects of exemestane on bone strength. This research will inform us on the safety of~     exemestane for breast cancer prevention.~   "
184903|NCT01144455|"~     The purpose of this study is to determine whether Gemcitabine versus Gemcitabine and TH-302~     are effective in the treatment of subjects with first-line metastatic pancreatic~     adenocarcinoma.~   "
184904|NCT01144442|"~     This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian,~     fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive~     surgery following by adjuvant chemotherapy. It is expected that this first surgery was~     optimal - as defined as no residual tumor > or = 1 centimeter. Patient has clinical evidence~     of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate)~     heated and administered into the abdomen, followed by hyperthermic intraperitoneal~     chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after~     surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6~     cycles.~   "
184905|NCT01144429|"~     Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the~     correct dose.~      4 concentrations of a birch pollen allergen extract are applied in this study. Duration of~     therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e.~     comparison between treatment arms of increased amount of quantities of allergen to provoke a~     positive CPT at the end of treatment.~   "
184906|NCT01144416|"~     The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is~     non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during~     the first week of ovarian stimulation in terms of the number of vital pregnancies (ie,~     presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days~     after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation~     (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).~   "
184907|NCT01144403|"~     This multicenter, open-label study will assess the efficacy and safety of MabThera~     (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell~     Lymphoma not eligible for autologous stem cell transplantation. Participants will receive~     MabThera (372 mg/m^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to~     standard chemotherapy for 6 cycles. In participants experiencing complete or partial~     response, MabThera will be continued as consolidation therapy for 2 more cycles.~   "
184908|NCT01144390|"~     The purpose of this study is to explore barriers and determine whether optimizing protocol is~     effective in the treatment of heroin dependence in community-based MMT clinics.~   "
184909|NCT01144377|"~     The primary objectives of this study include evaluating the dose response of LY2541546 using~     bone mineral density (BMD) change from baseline as compared to placebo and evaluating the~     overall safety and tolerability of LY2541546 following multiple subcutaneous administrations~     in postmenopausal (PMP) women with low BMD. Following the last dose of study drug,~     participants will be able to participate in a 12 month extension to collect additional safety~     and efficacy data (no further treatment will be administered during this extension).~   "
184910|NCT01144364|"~     This study will evaluate the efficacy and safety of brief induction therapy with a~     chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with~     MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the~     target sample size is 100-500 individuals.~   "
184911|NCT01144351|"~     The purpose of this study is to determine the safety and tolerability of ELND002 in patients~     with relapsing forms of secondary progressive multiple sclerosis (SPMS) or~     relapsing-remitting multiple sclerosis (RRMS).~   "
184912|NCT01144338|"~     This study will compare the impact of including exenatide once weekly in addition to usual~     care vs. usual care without exenatide on major cardiovascular outcomes as measured by the~     primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction~     (MI), or nonfatal stroke.~   "
184913|NCT01144325|"~     The purpose of this prospective randomized study is to compare clinical outcomes from two~     different patient position(prone vs left decubitus)with thoracoscopic esophageal mobilization~     in the procedure of Minimally Invasive Esophagectomy (MIE).~        -  Comparing morbidities from the two groups~        -  Comparing short-term quality of life from the two groups~        -  Comparing oncological results (3,5 year survival) from the two groups~   "
184914|NCT01144312|"~     The aim of this study was to characterize pharmacokinetics of fentanyl during and after~     Living Donor Liver Transplantation (LDLT), using population pharmacokinetic analysis with non~     linear mixed effects modeling.~   "
184915|NCT01144299|"~     This study is designed to test the immunogenicity and reactogenicity of the~     Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for~     the 2010-2011 season.~   "
184916|NCT01144286|"~     In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal~     candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will~     be conducted to compare the therapeutic efficacy, safety and tolerability of three different~     doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).~   "
184917|NCT01144273|"~     Randomized double blind placebo controlled trial on transversus abdominus plane block~     approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.~   "
184920|NCT01144234|"~     HIV /AIDS is a major public health problem in Uganda. The prevention of mother to child~     transmission of HIV/ AIDS (PMTCT) was launched in Uganda in November 2001 and in Mbale~     Hospital in May 2002. Currently, PMTCT services have been integrated into mainstream~     antenatal care services throughout the country.~      Though engaging men as partners is a critical component in the PMTCT programme, their~     involvement has been low. Measures to increase male partner involvement in the PMTCT~     programmes have not been explored in Uganda.~      Objectives: To determine the effect of a written invitation letter to the spouses of women,~     attending their first antenatal visit on: (a) couple attendance at subsequent antenatal~     clinic visits; and (b) couple acceptance of HIV testing.~      Study site: The study will be carried out at Mbale Regional Referral Hospital in eastern~     Uganda~      Study design: A randomised clinical trial among 1060 (530 intervention and 530 control) new~     antenatal attendees. The intervention will be a written invitation letter to their spouses.~      Outcome measures: The main outcome measure is the proportion of pregnant women who come with~     their partners for ANC at the subsequent antenatal visit.~      Utility: The results of this study will be utilised in re-orienting the ANC services to~     encourage male participation and hopefully improve the uptake of the PMTCT services at Mbale~     Regional Referral Hospital.~   "
184921|NCT01144221|"~     This is an evaluative, monocentric study in patients with chronic ischemic heart disease and~     left bundle branch block who received an ICD-CRT. It is an early investigation on the safety~     and effects of a single administration of bone marrow derived mononuclear cells after~     implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.~   "
184922|NCT01144208|"~     The purpose of this study is to evaluate if poor bone quality increases the risk of specific~     types of treatment complications in patients with distal radius fractures treated with open~     reduction and Locking Compression Plates(LCP).~   "
184923|NCT01144195|"~     First line chemotherapy treatment regimens for metastatic colorectal cancer (mCRC) present~     disease-free survival of more than 10 months, and as much as 12 and 15 months for many~     patients.~      It is evident that there are 2 groups of patients with metastatic colorectal cancer(mCRC):~     those who progress during first line treatment or in the 6 months following the last~     chemotherapy infusion and those who progress after this first 6-month period.~      There are currently no studies evaluating the efficacy of second line chemotherapy regimens~     according to the duration of response to first line treatment. It seems logical that patients~     with less aggressive tumours will benefit more from treatments targeting specific proteins,~     such as panitumumab, due to the shorter duration of these tumours cell cycle, which makes~     them less sensitive to chemotherapy.~      This study is therefore justified to determine an increase in activity and control of the~     disease in patients who progressed after 6 months of the last first line chemotherapy~     infusion for metastatic colorectal cancer(mCRC) in subjects expressing wild-type KRAS.~   "
184924|NCT01144182|"~     Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the~     most common indication for readmission in older adults and the most frequent reason for~     30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy~     to lower HF recurrence. However, adherence to medications and dietary recommendations is low~     in HF patients. Nonadherence is often due to an interaction among the environment, the~     patient and providers. In the VALOR in Heart Failure Study, we will assess a novel quality~     improvement program (QIP) to improve HF care using a pretest-posttest design. This~     interdisciplinary theory-based prospective experimental study will target improving HF~     treatment using patient-based behavioral and checklist intervention, as well as provider and~     system-targeted checklists and treatment defaults (posttest or intervention phase); this will~     be compared to current best practice (CBP) evaluated in the pretest (pretest or~     pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient,~     provider and system levels, will improve QOL and lower HF recurrence compared to CBP.~   "
184925|NCT01144169|"~     The main goal of this research study is to determine whether treating patients with renal~     cell cancer with hydroxychloroquine before surgery can make the cancer easier to kill.~     Another goal is to see how the study drug affects the body's immune cells which fight cancer~     cells.~   "
184926|NCT01144156|"~     The study hypothesis is that adalimumab induces mucosal healing in the small bowel and that~     mucosal healing correlates with disease activity. 30 Patients with isolated active small~     bowel Crohn's disease which are candidates to receive anti-TNF treatment will be included in~     the study. All patients will undergo patency capsule examination and capsule endoscopy~     afterwards. Small bowel endoscopic disease severity will be assessed by the capsule endoscopy~     Crohn's disease activity index (CECDAI). The patients will receive Adalimumab~     (Humira)injections (160mg,80mg and 40mg every 2 weeks ) for 12 weeks. on week 14 a second~     capsule endoscopy will be performed and CECDAI calculated again. The patients clinical~     condition, CDAI,IBDQ and laboratory results including CRP, CBC and fecal calprotectin will be~     assessed on weeks o, 7 and 14 and results will be compared with the endoscopic score.~   "
184927|NCT01144143|"~     The purpose of this study is to determine if an anti-inflammatory drug, called infliximab,~     will reduce inflammation in the synovial lining in patients with an early stage of~     osteoarthritis of the knee. It will also help determine if the study medication decreases the~     accumulation of synovial fluid and prevents cartilage breakdown.~   "
184928|NCT01144130|"~     The purpose of this study is to quantify the degree of sleep disturbances after hip or knee~     replacement surgery.~      Through polysomnographic monitoring the disturbances in sleep stages will be clarified.~   "
184929|NCT01144117|"~     In a double-blind, placebo-controlled, parallel group trial, recombinant human erythropoietin~     (rhEPO) (48000 IU) treatment or placebo will be administered weekly i.v. for 24 weeks: weekly~     for 12 weeks and bi-weekly for 12 weeks. Methylprednisolone (MP) 1 g i.v. will be~     administered before the first and second EPO/placebo administration. The 24-week treatment~     period will be followed by a 24-week observation period.~   "
184936|NCT01144026|"~     This protocol represents the second in human study of TUTI-16, and is being conducted to~     continue to gather safety and human immunogenicity (anti-HIV-1 Tat titers) data of~     subcutaneously administered TUTI-16.~   "
184937|NCT01144000|"~     To determine the outcome and safety of a combined antimicrobial treatment involving~     daptomycin and surgical approach involving retention or short-interval two-stage exchange of~     the implant. Patients with hip, knee and shoulder Prosthetic Joint Infection (PJI) caused by~     methicillin-susceptible and methicillin-resistant staphylococci will be included and followed~     during 2 years.~   "
184930|NCT01144104|"~     This trial consists of two linked substudies.~      Substudy 1: Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness~     Study~      Substudy 2: Activating Messages for Enhancing Primary Care Practice (AMEP2): Toxicity Study~      The purpose of the Effectiveness Study is to assess the comparative effectiveness of three~     multimedia educational interventions (a targeted educational video, a tailored interactive~     multimedia computer program, and an attention control) for increasing the likelihood that~     primary care patients with significant depressive symptoms will seek appropriate care (n =~     510). The primary study outcomes are provision of minimally acceptable initial care,~     reductions in depression-related stigma, and improvement in depression symptoms. (See Process~     of Care and Patient Outcomes in Primary Outcome Measure section.)~      The purpose of the Toxicity Study is to assess the potential benefits (reduced stigma) and~     harms (inappropriate prescribing) associated with three multimedia depression educational~     interventions when administered to patients with few or no depressive symptoms (n = 308). The~     primary outcomes relating to this outcome are reducing depression-related stigma and reducing~     unnecessary prescribing. (See Toxicity in Primary Outcome Measure section.)~      Both studies will look at the secondary outcome measure of patient requests for depression~     treatment.~   "
184931|NCT01144091|"~     The investigators will study 2 separate groups:~        -  Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous~          coronary intervention).~        -  Patients undergoing CT examination with contrast medium. All patients will receive~          intravenous (I.V) hydration for 8-12h before and 36 to 48 h after angiography with 0.45%~          saline 100ml/h.~      All patients will receive oral N-acetyl cysteine 1200 mg twice daily, a day before, on the~     day of the angiography and for another 48 hours.~      In addition, patients will be assigned to receive oral pentoxyphylline (P group) or placebo~     (C - control group) tablets 3 times a day one day before, on the day of the procedure and for~     another 48 hours.~      Baseline Serum Creatinine (S.Cr) levels in will be taken before angiography and two days~     after angiography. Radio-contrast nephropathy is defined, in this study, as increase in serum~     ≥ 25 % of baseline after injection of the radio-contrast agent. Pentoxyfylline is an orally~     active haemorheological agent for the treatment of peripheral vascular disease,~     cerebrovascular disease and a number of other conditions involving a defective regional~     microcirculation. Pentoxyfylline acts primarily by increasing red blood cell deformability,~     by reducing blood viscosity and by decreasing the potential for platelet aggregation and~     thrombus formation (mechanism unclear). Pentoxyfylline has also proven to have a significant~     anti inflammatory effect as well as anti oxidant effect, mechanisms considered to be~     important patho-physiological causes of contrast induced nephropathy.~   "
184932|NCT01144078|"~     Body fat is an important risk factors for type 2 diabetes. However, not all body fat is the~     same. Research suggests that fat stored in the abdomen is most harmful. This is known as~     intra-abdominal fat. The objective of the proposed study is to understand the effect of~     exercise intensity on intra-abdominal fat and glucose control. Twenty participants with type~     2 diabetes will be assigned to traditional or high intensity exercise. The exercise~     interventions will last a total of 14 weeks. Those in the traditional intensity group will~     exercise at an intensity comparable to walking. The high intensity group will alternate~     between 1 minute at high intensity and 3 minutes at low intensity. Both exercise groups will~     burn a similar amount of Calories and will exercise for the same amount of time. The exercise~     duration will start at 30 minutes per day. By the end of the study, it will be 60 minutes per~     day. All exercise sessions will be supervised. Body fat distribution will be estimated by a~     scanning machine called a DXA and anthropometric measures. Glycemic control will be measured~     from a blood sample. This study may not be of sufficient size to detect meaningful changes in~     these variables. However, it will provide information in regards to the preliminary efficacy,~     resource requirements and feasibility. Feasibility will include: recruitment, retention and~     adherence. Such information is essential for planning a more definitive trial. The~     identification of exercises that target greater reductions in abdominal fat will have~     important implications for the health of people with diabetes.~   "
184933|NCT01144065|"~     The purpose of this study is to determine whether hair levels of cortisol and testosterone~     are elevated in patients with acute MI compared to controls.~   "
184934|NCT01144052|"~     Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young~     adults. The management of MS-patients requires treatment with disease-modifying agents,~     monoclonal antibodies such as natalizumab or immunosuppressants. Natalizumab showed good~     efficacy and is approved for treatment of relapsing MS with a number of restrictions due to~     safety issues. Cognitive data related to natalizumab treatment are still scarce.~     Interferon-beta-1b is approved for high-frequency, subcutaneous (sc) administration in the~     treatment of multiple sclerosis. It reduces the relapse rate, severity, hospitalisation and~     the disease activity as seen on MRI.~      This is a pilot study to explore the concept of de-escalating natalizumab treatment to~     interferon-beta-1b e.o.d compared to continuous treatment with natalizumab in patients with~     relapsing-remitting multiple sclerosis previously treated with natalizumab for 12 months. The~     study is designed as prospective, controlled, randomized, rater-blinded, parallel-group, two~     arm, mono-centric including patients of the Ticino Cohort. One arm will be treated with~     Interferon-beta 1b 250mcg given subcutaneously every other day, the other with Natalizumab~     300 mg given intravenously (i.v.), every four weeks. The treatment duration is 12 months, the~     follow-up period 12 months. The time to first on-study relapse will be compared between the~     to treatment arms (primary outcome). Other efficacy parameter include clinical and~     radiological parameters, patient reported outcome on quality of life and fatigue. Safety is~     assessed by reports of adverse events.~   "
184935|NCT01144039|"~     Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and~     overall hemodynamics were studied in patients undergoing elective aortic valve replacement~     with severe aortic stenosis and associated left ventricular hypertrophy .~      Methods: 25 patients will be included in this double-blind randomized placebo-controlled~     study. Glutamate was administered intravenously immediately after aortic cross-clamp release.~     The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1~     h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal~     echocardiography (TEE) is used to measure diastolic and systolic ventricular function before~     sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally~     routine hemodynamic parameters are measured intraoperatively.~   "
184938|NCT01143987|"~     Active parathyroid glands among renal dialysis patients contribute to calcified and hardened~     blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms~     of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular~     calcification. Role of cinacalcet was demonstrated in animal model but human data are~     lacking. The investigators designed an open label pilot study to evaluate the effect of~     cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary~     hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave~     velocity at 26 and 52 months after cinacalcet treatment.~   "
184939|NCT01143974|"~     For patients resistant to enthrycycline and taxanes, there is no standard regimen. Pemetrexed~     alone had certain efficacy in treatment of advance breast cancer. Platin was also a effective~     drug for advanced breast cancer. The combination of these two drug may have a synergy with~     each other in treatment of advanced breast cancer.~   "
184940|NCT01143961|"~     Surveillance of the lungs for bacteria is routinely undertaken in artificially ventilated~     patients as these individuals are at high risk of developing pneumonia. Knowledge of the~     types of bacteria present allows the rapid treatment with the correct antibiotics if a~     pneumonia develops. Surveillance is undertaken using a technique called non-directed~     bronchoalveolar lavage (NBL), which can be performed by the bedside nurse. This involves~     suctioning some of the lung secretions into a sample pot and sending it to the microbiology~     laboratory to identify any bacteria present. When this procedure is performed there is some~     collapse of the lung due to escaping gas. The purpose of this study is:~        1. To use a non-invasive imaging technique known as electrical impedance tomography (EIT)~          to measure the amount of lung collapse during an NBL. Half of the patients in the study~          will have a one-way adapter valve connected to the breathing circuit. This adapter is~          designed to make the insertion of a suction catheter easier and prevent the loss of gas.~        2. Look at which region of the lung the sample is being collected from as the suction tube~          used to take the samples may pass into either the left or right lung.~      EIT is a simple non-invasive technique which has been in use for many years. It uses pairs of~     electrodes around the chest through which imperceptible currents are passed. A computer shows~     an image of which parts of the lungs have the most or least air in them. This has the~     advantage over other imaging techniques in critical care that it does not use radiation and~     gives a real time picture at the bedside of the variations in ventilation throughout the~     lungs.~   "
184941|NCT01143948|"~     Liver disease is an important cause of death in type 2 diabetes. In the population-based~     Verona Diabetes Study cirrhosis was the fourth leading cause of death and accounted for 4.4%~     of diabetes-related deaths. In another prospective cohort study , cirrhosis accounted for~     12.5% of deaths in patients with diabetes. In Egypt hepatitis C virus the commonest of~     cirrhosis here has a prevalence of 9.8% in the population with the greatest burden over~     national health care bills. Patients with cirrhosis & type 2 diabetes mellitus are always~     showing up in all hospital wards without a clear consensus of best management of their~     hyperglycemia.~   "
184942|NCT01143935|"~     Estimation of liver volume is important for live donor liver transplant as well as extended~     liver resections. Computed tomography (CT) volumetry which is currently a gold standard for~     liver volumetry , is a time consuming process. A quicker method to estimate liver volume is~     essential. The aim of the present study is to try and formulate an equation based on patients~     height, weight etc to estimate liver volume.~   "
184943|NCT01143922|"~     Currently available investigating modalities like CT scans, MRI etc although have a high~     accuracy in staging of gastrointestinal(GI) tract malignancies, are not correct in all cases~     . The aim of this study is to assess the role of intraoperative ultrasound as a modality to~     increase the staging accuracy of GI tract malignancies~   "
184944|NCT01143909|"~     With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically~     ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care~     (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness~     and costs of omitting prophylactic FFP transfusion compared to current practice of~     prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.~   "
184945|NCT01143896|"~     Chronic infection with hepatitis C (CHC) is a common and expensive condition, and it~     disproportionately affects Veterans. Treatment with antiviral therapy reduces liver disease~     progression and improves health related quality of life. However, ~70% of Veterans with CHC~     are considered ineligible for antiviral treatment. Most of these patients are excluded due to~     the presence of co-existing depression and substance use. The proposed project will adapt and~     adopt an evidence-based collaborative depression care model in CHC clinics. By removing the~     leading contraindication for antiviral treatment, this project will potentially yield~     benefits that go far beyond the obvious quality of life benefit from antidepressant therapy~     itself.~   "
184946|NCT01143883|"~     This clinical study is a prospective, randomized, controlled trial of patients undergoing~     elective colorectal surgical procedures that receive an abdominal skin incision of at least 6~     cm. Treatment with Silverlon® will be compared to standard postoperative dressings of 4x4~     Gauze and paper tape. Patients will be randomized with a 1:1 treatment allocation ratio to~     receive either 1) Silverlon® or 2) standard postsurgical dressing. Neither the Investigators~     nor the participants will be blinded to the treatment modality after randomization.~      Silver has long been known to have antimicrobial properties. It interacts with structural~     proteins and DNA, inhibiting bacterial replication and causing fatal structural changes~     within the cell wall. It has broad antimicrobial activities and unlike antibiotics, it is~     rarely associated with microbial resistance. Silverlon® is a silver-nylon dressing~     specifically designed for surgical wounds to prevent the development of surgical site~     infections. It is an easy to use product with no known microbial resistance or adverse~     effects. The efficacy of Silverlon® in preventing surgical site infections has been shown in~     several retrospective studies but as of yet has not been tested in a prospective fashion. The~     objective of this study is to perform a prospective, randomized, clinical trial directly~     comparing the incidence of surgical site infections in patients treated with Silverlon® to~     standard postoperative dressing following elective colorectal surgery~   "
185094|NCT01141933|"~     The purpose of this study is to test the efficacy of a cognitive-existential intervention~     (using either an individual or a group format) to improve the existential and global quality~     of life of patients as compared to usual care in a population of adult non-metastatic cancer~     patients.~   "
184947|NCT01143870|"~     The percent of glycosylated hemoglobin, also known as a hemoglobin A1C value, is the standard~     way that clinicians assess a patient's diabetes control. Numerous studies have shown that~     maintaining a hemoglobin A1C value less than 7% is associated with lower rates of~     diabetes-related complications. Clinicians use this value to determine whether a patient with~     diabetes requires changes in their disease management. The main problem with this practice is~     that many patients do not understand what this number means. The goal of this project is to~     examine ways to make feedback about glycemic control easier for patients to understand. The~     hope is that improved patient understanding will result in an improvement in diabetic control~     and thus a reduction in disease-associated complications. Patients with a diagnosis of~     diabetes and a hemoglobin A1C value greater than 8% within the preceding three months will be~     eligible for the study. Pregnant women will be excluded. Given the nature of the intervention~     we will also exclude patients with cognitive deficits. In this study, patients will be~     randomized to three groups. The first group with be told their HgbA1C value only, the second~     group will be told a letter grade interpretation of that value, and the third group will be~     shown a face. The face emotions will range from happy to sad reflecting the level of control.~     The main outcome will be trend in hemoglobin A1C values over time. Secondary outcomes will~     include patient understanding of disease state and the number of hemoglobin A1C values~     checked following the intervention.~   "
184948|NCT01143857|"~     Cocaine use, abuse and dependence is a public health problem that is directly responsible for~     hundreds of billions of dollars in health care expenditures per year. Relapse rates to~     cocaine use are high, creating a pressing need to develop effective therapies for cocaine~     dependence. The proposed research will focus on investigating the determinants and~     consequences of cocaine dependence via measurement of physiological, behavioral and~     subjective effects of acute doses of cocaine in healthy non-drug dependent human volunteers~     in the laboratory, and through examination of the effects of pharmacotherapies on the above~     effects of cocaine. This study will examine cocaine-derived reinforcement under week-long~     sub-chronic varenicline (Chantix) dosing, and under placebo conditions. The study is a~     within-subjects crossover design using 24 subjects. Subjects will be screened and consented~     into the study at the Treatment Research Center (TRC). Study visits where behavioral and~     physiological outcome data will be obtained will be conducted at the Clinical and~     Translational Research Center (CTRC) of the Hospital of the University of Pennsylvania.~     Subjects will be outpatients for this trial, with CTRC sessions scheduled at least one week~     apart.~   "
184949|NCT01143844|"~     Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience~     endocrine changes more similar to women in their late reproductive years than to same-age~     peers. These changes will be more dramatic in women who receive high dose therapy compared to~     women who receive low dose therapy.~      At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual~     diary keeping, pelvic ultrasound and blood hormones tests will be used to measure ovarian~     reserve , that is the number and quality of the eggs that remain in the ovaries. The study~     will also try to learn if those who received higher doses of certain chemotherapies are more~     likely to have changes in these tests sooner than those women who received smaller doses of~     these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look~     for gene variations that may predict susceptibility to ovarian damage from cancer treatments.~     Information learned from this study may help researchers to develop guidelines to identify~     problems with a female cancer survivor's ovaries before irregular menses or other symptoms of~     ovarian failure occur.~   "
184950|NCT01143831|"~     The purpose of this study is to evaluate factor levels of the pro coagulant factors II, VII,~     IX, X, and the anticoagulant factors protein C and S in healthy volunteers during the intake~     of elevated levels of vitamin K in order to investigate whether there is any evidence that~     high dose vitamin K intake increases plasma coagulation factor activity.~   "
184951|NCT01143818|"~     Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men~     in the community over 6 months.~   "
184952|NCT01143805|"~     In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate~     occasions by two different routes of administration: One time by mouth in tablet form and one~     time by vein (intravenous form). The amount of CP-690,550 available in the blood following~     administration by vein will be measured and is expected to reflect the maximum amount~     possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the~     blood following oral tablet administration will also be measured and compared to that~     achieved following administration by vein in order to estimate how much of the maximum amount~     possible is actually absorbed into the blood following administration by mouth as a tablet.~   "
184953|NCT01143792|"~     Youth who leave home for the streets are at significantly more risk for a multitude of~     problems, yet little research is available to guide treatment intervention efforts with this~     population. Studies document high rates of substance use, HIV risk, mental health problems,~     teenage pregnancy and criminality. Research to date examining homeless, street living youth~     has been primarily descriptive; less effort has been directed towards developing and~     evaluating treatment interventions for this group. The majority of homeless youth do not~     receive substance abuse treatment, with one study reporting that only 15% of street living~     youth report ever receiving mental health services. The effectiveness of the Community~     Reinforcement Approach (CRA) with street living youth was studied in our recently completed~     Stage 1 trial. The proposed study is a Stage II clinical trial examining outcome of CRA~     individual therapy as compared to two interventions commonly employed, yet little researched,~     with this group. All clients will be randomized to one of three theoretically distinct~     interventions: (1) CRA therapy, (2) Motivational Enhancement Therapy (MET), or (3) Case~     Management (CM). The relative effectiveness of these interventions will be evaluated at 3, 6,~     and 12 months post-baseline. The Social Ecology Theory of Development (Bronfenbrenner, 1979)~     guides our change hypotheses and intervention. Proposed change mechanisms (mediators) for~     each intervention will be evaluated. Differential treatment response as a function of~     ethnicity, gender, age, sexual orientation and abuse (moderators) will be investigated to~     better understand the interventions. The study will also examine how, if at all, treatment~     engagement, retention and expectations impact youth response to the three treatments.~     Information gained through this project may help address the gap in our understanding of how~     best to effectively intervene with a group at high risk for continuing health and~     psychological problems.~   "
184954|NCT01143779|"~     The goal of this clinical research study is to learn if an imaging solution,~     [F-18]-fluoro-L-thymidine (FLT), when used with a positron emission tomography (PET) scan,~     can help doctors to better see changes in the growth of tumors in the body. Researchers want~     to learn if FLT-PET scans can show an early response to chemotherapy.~   "
185369|NCT01138306|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in samples from young patients with acute~     myeloid leukemia.~   "
184957|NCT01143740|"~     This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in~     patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients~     will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per~     cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection~     may be treated for an additional 3 cycles with RO5045337.~   "
184958|NCT01143727|"~     This study compares two standard methods for cleaning the surface of wounds on the feet of~     patients with diabetes mellitus. The question being asked is whether inflammation of the~     wound affects the ability of one or both of the methods to work.~   "
184959|NCT01143714|"~     The purpose of this study is to assess the effect of four weeks of treatment with Santyl~     Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic~     foot ulcers over four weeks, and on the proportion of subjects achieving complete wound~     closure within 12 weeks from initiation of treatment.~   "
184960|NCT01143701|"~     ADHD is the most prevalent mental health disorder of childhood. The majority of children with~     ADHD receive their care in primary care settings. While the American Academy of Pediatrics~     (AAP) issued evidence-based guidelines and recommendations for pediatricians, most~     pediatricians have difficulty adhering to these guidelines. Given observed deficiencies in~     evidence-based ADHD care and the likely effects on child outcomes, the development and~     testing of interventions aimed at improving ADHD care in primary care settings is necessary.~     Cincinnati Children's Hospital Medical Center has developed a model intervention, termed the~     ADHD Collaborative, to comprehensively address this issue. The ADHD Collaborative~     intervention model includes academic detailing, quality improvement methods, and innovative~     tools (e.g., web portal) designed to promote and support the systematic use of the AAP~     guidelines. This intervention model has been used to train over 200 physicians at 55~     practices in the Greater Cincinnati area. The intervention appears to produce 2- to 4-fold~     increases in the use of evidence-based ADHD-related practice behaviors in participating~     physicians. To date, the intervention has been implemented as a quality improvement project~     with few experimental controls. The primary goal of the proposed study is to conduct an~     experimentally-controlled cluster randomized trial of the ADHD Collaborative intervention.~     Thirty-two pediatric practices will be randomly assigned to receive the ADHD Collaborative~     intervention or to provide usual care. Approximately 96 physicians and 576 of their ADHD~     patients will be included in the study. Chart reviews, parental interviews, and parent and~     teacher rating scales will be collected. Between- and within-group hierarchical linear~     modeling analyses will examine whether the intervention produces significant improvements in~     pediatrician practice behaviors, patient satisfaction with ADHD care, and child outcomes over~     and above typical ADHD care. Also, the relative cost effectiveness of the ADHD Collaborative~     intervention over typical care will be established by computing incremental~     cost-effectiveness ratios using cost and effect size estimates.~   "
184961|NCT01143688|"~     The investigators hypothesize that different placebos will have different effects on~     subjective and objective asthma outcomes compared with actual therapy and natural history. .~      Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture,~     albuterol inhaler, or no treatment in random order, on three different occasions each. At~     each of the 12 visits, spirometry is performed repeatedly over 2 hours. Maximum FEV1 achieved~     and an 11-point, self-reported scale of improvement are examined.~   "
184962|NCT01143675|"~     The purpose of this study is to evaluate if poor bone quality increases the risk of specific~     types of treatment complications in patients with proximal humerus fractures treated with~     open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).~   "
184963|NCT01143662|"~     This study is a multi-center, randomized, open-label and positive controlled Phase II~     Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3~     dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B~     characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed~     to establish a dose response and safety relationship sufficient to allow the subsequent~     design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon~     alfa-2b in hepatitis B patients to satisfy regulatory requirements.~   "
184964|NCT01143649|"~     The purpose of this study is to determine whether noninvasive brain stimulation associated~     with motor learning offers an additional benefit than motor learning alone in patients with~     stroke.~      The investigators hypothesis is that active transcranial direct current stimulation (tDCS)~     combined with constraint induced movement therapy (CIMT) will induce a greater motor function~     improvement as compared with sham tDCS combined with CIMT.~   "
184965|NCT01143636|"~     The purpose of this study is to determine whether transcranial direct current stimulation~     (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is~     that tDCS will decrease pain significantly when compared to sham stimulation.~   "
184966|NCT01143623|"~     The purpose of this study is to determine the dose response effect of probiotic capsules for~     the prevention of antibiotic-associated diarrhea (AAD).~   "
184967|NCT01143610|"~     Different surgical techniques have been proposed for root coverage, showing varying results~     especially in areas of deep recessions. The aim of this study is to evaluate the~     effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller~     class I or II deep recessions, requiring regeneration of lost periodontal tissues. Sample~     should be comprised of patients aged 18-45 years, both genders, presenting at least one site~     with marginal tissue recession >4mm. Patients will be randomly assigned to either one of the~     groups, based on treatment technique: newly forming bone (NFB) or subepithelial connective~     tissue graft (SCTG). Clinical examinations will be performed by a single blinded examiner at~     baseline, 1, 3, 6 and 9 months after surgery. Intra-group analysis will be performed by one~     way analysis of variance for repeated measures. Inter-group analysis will be performed by~     unpaired t-test for each of evaluation periods.~   "
184973|NCT01143532|"~     Background:~      - Genetic variation in a particular chromosome is a major contributor to the increased risk~     for kidney disease that is common in people of African descent, although the specific gene,~     mutations, and other aspects of the variations remain to be determined. By studying the~     outcomes of kidney transplant in donors and recipients of African descent, researchers hope~     to better understand the effects of this genetic variation on the success of kidney~     transplants.~      Objectives:~      - To examine possible connections between genetic variations and kidney transplant outcomes~     for donors and recipients.~      Eligibility:~        -  <TAB>Participants in kidney transplant where both donor and recipient were of black~          African descent.~        -  <TAB>Eligible transplants include both living donor and deceased donor.~      Design:~        -  The study will involve one visit of up to 8 hours.~        -  All participants will provide a detailed personal and family medical history.~        -  All participants will provide blood and urine samples, including a 24-hour urine~          collection, to test kidney function and collect material for genetic testing.~        -  Donor participants will also have a magnetic resonance imaging (MRI) scan of their~          remaining kidney.~   "
184968|NCT01143597|"~     The long-term goal of this project is to develop rehabilitation strategies that facilitate~     optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The~     objective of the studies proposed in this application is to determine whether a protocol of~     massed practice + somatosensory stimulation (MP+SS) is more effective for improving skilled~     hand use compared to a somatosensory stimulation (SS) alone, and to determine whether these~     approaches are each more effective than traditional therapy (consisting of conventional~     resistance training; CRT).~      Specific Aim I: In individuals with chronic incomplete tetraplegia, quantify changes in~     skilled hand use and sensory function associated with either: massed practice training~     combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control~     (conventional resistance training [CRT]), and compare differences among groups. The~     investigators hypothesize that:~      H1.1: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor~     function (Jebsen-Taylor Hand Function Test and Chedoke-McMaster Arm and Hand Activity~     Inventory) and sensory function (quantitative sensory tests; QST) will be greater in~     individuals who are trained using MP+SS compared to the SS and RT groups.~      H1.2: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor~     function and sensory function tests will be greater in individuals who are trained using SS~     compared to CRT.~      H1.3: At 6 months post training, motor and sensory gains will be retained by the MP+SS and SS~     groups.~      Specific Aim 2: In individuals with chronic incomplete tetraplegia, quantify changes in~     cortical and spinal neurophysiology associated with either: massed practice combined with~     somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional~     resistance training [CRT]), and compare differences among groups. The investigators~     hypothesize that, after 4 weeks:~      H2.1: Measures representing cortical neurophysiologic function (i.e., motor-evoked potential~     amplitude and location of cortical map) will show greater change in the direction of more~     normal values in individuals who are trained using MP+SS compared to the SS and the CRT~     groups.~      H2.2: Measures representing spinal neurophysiologic function (i.e., F-wave and H-reflex~     amplitude) will show greater change in the direction of more normal values in individuals who~     are trained using SS compared to the MP+SS and the CRT groups.~      H2.3: There will be a positive relationship between change scores associated with functional~     outcome measures and cortical neurophysiologic outcome measures in the MP+SS group; there~     will be a positive relationship between change scores associated with the functional outcome~     measures and spinal neurophysiologic outcome measures in the SS group.~      Specific Aim 3: In individuals with chronic incomplete tetraplegia, quantify changes in~     self-assessment of quality of life and societal participation associated with massed practice~     combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS) or control~     (conventional resistance training [CRT]), and compare difference among groups. The~     investigators hypothesize that:~      H3.1: Gains in scores on standardized measures of quality of life (Medical Outcomes Study~     Short Form 36 [SF-36]) and societal participation (Impact on Participation and Autonomy~     Questionnaire [IPAQ]) will be greater in individuals who are trained using MP+SS compared to~     both the SS and the CRT groups.~      H3.2: Gains in scores on standardized measures of quality of life and societal participation~     will be greater in individuals who are trained using SS compared to the CRT group.~      H3.3: At 6 months post training, gains in the quality of life and the societal participation~     measures will be retained by the MP+SS and SS groups.~      Risks: This is a low risk study that investigates the effects of standard rehabilitation and~     exercise interventions on hand/arm function in individuals with SCI. All devices are~     considered minimal risk devices by the FDA.~   "
184969|NCT01143584|"~     To study the effects of rapid escalation of Cabergoline in comparison to conventional dosing~     in macroprolactinomas. Rapid escalation of cabergoline may help in earlier normalization of~     prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline~     altogether.~   "
184970|NCT01143571|"~     Background:~        -  Most studies of infectious agents have focused on specific microbes, such as human~          papillomaviruses and cervical cancer, and the hepatitis B and C virus and liver cancer.~          The skin and many internal areas (including the mouth and the gastrointestinal tract)~          also contain large numbers of naturally occurring microbes, but these areas have not~          received as much study.~        -  Some of the infectious agents that naturally reside in the body may have an effect on~          health. The study of naturally occurring microbes in the human body is a new area of~          research, and much remains to be learned regarding the extent and pattern of their~          appearance and appropriate techniques for testing them.~        -  Researchers are interested in collecting human samples from areas known to contain~          naturally occurring microbes. These samples will provide baseline information for~          further studies.~      Objectives:~      - To collect a set of study samples from individuals who have applied to participate in a~     study assessing the relationship among the bacteria H. pylori, peptic ulcer disease, and~     gastric cancer.~      Eligibility:~      - Individuals between the ages of 21 and 65 who are participating in the clinical trial~     entitled A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter~     Pylori.~      Design:~        -  Researchers will collect oral (saliva), colonic, and skin swab samples from study~          participants who tested positive for the presence of the H. pylori bacteria. These~          samples will be collected at the three study visits (enrollment, 6 weeks, and 1 year).~        -  Researchers will also collect samples from people who applied for the clinical trial but~          did not test positive for H. pylori. These samples will be collected at the enrollment~          visit and 1 year later.~        -  Blood samples will be collected at each study visit.~   "
184971|NCT01143558|"~     Background:~      Lyme disease is an infection caused by Borrelia burgdorferi, a bacteria that is transmitted~     to humans by ticks. It can cause many different symptoms including rash, fever, headache,~     meningitis (infection of the central nervous system), and arthritis. While most patients~     improve after taking antibiotics, some patients continue to have symptoms. It is currently~     unknown why some patients continue to have symptoms. One possibility is that the antibiotics~     have not successfully gotten rid of all of the bacteria. Current tests for Lyme disease~     cannot tell whether the bacteria have been successfully eliminated from the body.~      Xenodiagnosis is a way to look for Borrelia bacteria using the animal that usually hosts~     them, Ixodes scapularis (also known as the deer tick). This method takes advantage of the~     evolution of the bacteria and the insect that transmits the infection, which can make the~     insect particularly good at finding the agent. In studies of animals, xenodiagnosis may be~     more sensitive than current tests for detecting the presence of the Lyme disease bacteria.~     Researchers are interested in using xenodiagnosis to determine whether uninfected ticks that~     feed on humans who have been infected with Lyme disease bacteria can detect the continued~     presence of live bacteria.~      Objectives:~      - To determine whether xenodiagnosis can be used to successfully investigate the presence of~     Lyme disease bacteria.~      Eligibility:~        1. Individuals at least 18 years of age who are in one of the following categories:~        2. Have had the erythema migrans rash (a symptom of Lyme infection) and received antibiotic~          therapy less than 4 months ago (but have not had antibiotics in the previous month).~        3. Have the erythema migrans rash and received less than 2 days of antibiotic therapy.~        4. Have been diagnosed with early or late Lyme disease, have received antibiotic therapy,~          but still have high levels of antibodies against the bacteria at least 6 months after~          therapy, and have not received antibiotics in the past 3 months.~        5. Have been diagnosed with early or late Lyme disease, have received antibiotic therapy,~          and have new complaints of fatigue or other symptoms that are persistent for at least 6~          months after completion of antibiotic therapy, and have not received antibiotics in the~          past 3 months.~        6. Have been diagnosed with Lyme arthritis and have not yet received antibiotic therapy.~        7. Healthy volunteers who have not had Lyme disease will also be included in this study.~      Design:~        -  Participants will have an initial visit for a physical examination, medical history, and~          blood sample.~        -  For the first study visit, researchers will place a strip of filter paper or a small~          plastic container with 20 to 30 disease-free ticks on the participant s skin. If~          possible, the ticks will be placed at the site of a Lyme disease rash or another~          suspicious area, or on the nondominant forearm. Participants will be asked to keep the~          ticks in place, and will keep a diary card at home to record any symptoms or problems.~        -  The ticks will be collected 4 to 6 days after placement. At that visit, participants~          will have a skin biopsy taken of the area tested, a blood sample will be collected, and~          participants will receive a new diary card to keep until the next clinic visit.~        -  After 1 month, participants will provide a final blood sample, and will receive a~          follow-up phone call 2 months afterward.~   "
184972|NCT01143545|"~     Background:~      - Certain types of lung, esophageal, or thymic cancers and mesotheliomas have specific~     antigens (protein molecules) on their surfaces. Research studies have shown that giving a~     vaccine that contains antigens similar to these may cause an immune response, which may keep~     tumors from growing. Researchers are also interested in determining whether the chemotherapy~     drug cyclophosphamide and the anti-inflammatory drug celecoxib may help the vaccine work~     better, particularly in patients with lung cancer.~      Objectives:~      - To evaluate the safety and effectiveness of tumor cell vaccines in combination with~     cyclophosphamide and celecoxib in patients with cancers involving the chest.~      Eligibility:~      - Individuals at least 18 years of age who have had surgery for small cell or non-small cell~     lung cancer, esophageal cancer, thymoma or thymic carcinoma, and malignant pleural~     mesothelioma.~      Design:~        -  Following recovery from surgery, chemotherapy, or radiation, participants will have~          leukapheresis to collect lymphocytes (white blood cells) for testing.~        -  Participants will receive celecoxib and cyclophosphamide to take twice a day at home, 7~          days before the vaccine.~        -  Participants will have the vaccine in the clinical center (one or two shots per month~          for 6 months), and will stay in the clinic for about 4 hours after the vaccine.~          Participants will keep a diary at home of any side effects from the vaccine, and will~          continue to take cyclophosphamide and celecoxib.~        -  One month after the sixth vaccine, participants will provide another blood sample for~          testing, and if the tests are satisfactory will return to the clinic every 3 months for~          2 additional vaccines.~        -  Participants will return to clinic for follow-up physical examinations, lab tests, and~          scans every 3 months for 2 years and then every 6 months for up to 3 years.~   "
184974|NCT01143519|"~     Background:~      - Research has shown that certain proteins in cells may be linked to higher risks of~     developing inflammations, tumors, and other medical problems. By examining how the blood~     cells of healthy volunteers respond to environmental exposures, researchers hope to better~     understand the relationship of genes, environmental factors, and human diseases.~      Objectives:~      - To examine how specific genes and proteins in blood cells respond to environmental~     exposures.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age.~      Design:~        -  The study will involve one visit of 45 to 60 minutes.~        -  Participants will be screened with a brief physical examination and finger stick to~          determine if they are eligible to donate blood for the study, and will complete a~          questionnaire about any medications or other drugs (e.g., cigarettes) they may be~          taking.~        -  Participants will provide a blood sample for research purposes.~   "
192328|NCT01046890|"~     The purpose of this clinical trial is to characterize drug interactions between one medicinal~     herb widely used by HIV infected patients: Echinacea sp. and the protease inhibitor~     darunavir/ritonavir.~   "
184975|NCT01143506|"~     Background:~      - The experience of volition that accompanies voluntary movement can be divided into the~     sense of will, or deciding to move, and the sense of agency, or feeling that the movement~     just made was self-generated. Very little is known regarding the neurological origin of this~     sense of volition. Previous research has shown that a particular part of the brain, the~     parietal lobe, is involved in our inner sense that we control the movements we make.~     Researchers are interested in determining if this sense relies on sensory information from~     moving fingers reaching the parietal lobe.~      Objectives:~      - To determine the brain regions responsible for the sense of volition and the associated~     sense of agency.~      Eligibility:~      - Healthy right-handed individuals between 18 and 55 years of age.~      Design:~        -  The study will involve a screening visit and two testing visits. The screening visit~          will last 30 minutes to 1 hour, and the testing visits will each last 3 to 4 hours.~        -  Participants will be screened with a physical examination and medical history.~        -  At each testing visit, participants will have a brain magnetic resonance imaging (MRI)~          scan, electroencephalography (EEG), and electromyography (EMG). The MRI scan and EEG~          will be done during a movement task that involves the thumb, second finger, and fifth~          finger of one hand. EMG will be used to monitor movements and muscle activity.~        -  During the second testing visit, participants will receive a nerve block using~          anesthetic, followed by the MRI, EEG, EMG and movement task. The nerve block will~          temporarily numb and prevent the movement of parts of the hand and fingers.~        -  After the MRI scan and EEG recording, participants will be asked to rate how much~          control they felt they had over choosing whether to move, and how much control they felt~          they had in actually making the movements.~   "
184976|NCT01143493|"~     Background:~      - Glucocorticoids are primary stress response hormones released from the adrenal gland when~     an individual is under stress. Chronic or ongoing elevation of these hormones due to~     prolonged stress or medical treatments can have numerous harmful effects. Researchers are~     interested in learning more about how these hormones affect cell growth, development, and~     death. To study glucocorticoid hormones, researchers plan to use the medication~     dexamethasone, which affects the parts of cells that respond to glucocorticoid hormones.~      Objectives:~      - To study glucocorticoid stress hormones in healthy individuals before and after receiving~     dexamethasone.~      Eligibility:~        -  Healthy individuals at least 18 years of age.~        -  Participants must not be using certain medications that may affect the dexamethasone~          test, including hormonal contraception, steroid-based drugs, and some antidepressants.~      Design:~        -  This study will require an initial screening visit and a second study visit. The visits~          are estimated to require about 1 to 2 hours of participation over a period of up to 14~          days.~        -  Participants will be screened at visit 1 with a full physical examination and medical~          history, and an initial blood sample for testing.~        -  For visit 2, participants will be asked to abstain from all food and drinks except for~          water for 12 hours before the appointment, and will take one tablet of dexamethasone 9~          hours before the appointment.~        -  Participants will have a second blood sample taken during visit 2, and will receive a~          snack after the blood is drawn.~   "
184977|NCT01143480|"~     Background:~      - Innate immunity is the process by which white blood cells and other parts of the immune~     system sense and respond to potential infections by causing an inflammation. Researchers are~     interested in studying how the body responds to certain environmental factors, and whether~     the body s response can contribute to chronic illnesses or diseases such as asthma and~     certain types of cancers.~      Objectives:~      - To examine how specific genes and proteins in blood cells respond to environmental~     exposures.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age.~      Design:~        -  The study will involve one visit of 45 to 60 minutes.~        -  Participants will be screened with a brief physical examination and finger stick to~          determine if they are eligible to donate blood for the study, and will complete a~          questionnaire about any medications or other drugs (e.g., cigarettes) they may be~          taking.~        -  Participants will provide a blood sample for research purposes.~   "
184978|NCT01143467|"~     Background:~      - Fatigue is a very common early and late side effect of cancer treatment, including~     radiation therapy. The cause of fatigue is poorly understood, making it hard to diagnose and~     treat. More research is necessary to understand why patients receiving cancer treatment~     experience fatigue. Changes in mitochondria, parts of body cells that help provide energy to~     the cell, may contribute to fatigue. Researchers are interested in looking at blood chemicals~     and mitochondrial genes of cancer patients to study those associated with fatigue.~      Objectives:~      - To study the relationship between fatigue and the effects of cancer treatment.~      Eligibility:~        -  Men at least 18 years of age who have been diagnosed with localized prostate cancer and~          are scheduled to receive external beam radiation therapy.~        -  Participants on study 09-NR-0088, Molecular-Genetic Correlates of Fatigue in Cancer~          Patients Receiving External Beam Radiation Therapy, are also eligible.~      Design:~        -  This study requires three outpatient visits to the NIH Clinical Center.~        -  Participants will be seen before they start radiation treatment, at the middle of~          treatment, and at the end of treatment. Each visit will take less than 30 minutes to~          complete.~        -  Participants will complete questionnaires that ask about fatigue and depression.~        -  Participants will provide blood samples for research testing and potential HIV testing.~        -  No treatment will be provided as part of this protocol.~   "
184979|NCT01143454|"~     Background:~      - Researchers are interested in studying individuals who have known or suspected metabolic or~     genetic diseases that put them at a high risk for heart diseases or diseases of their blood~     vessels. To improve the results of the study, both affected and nonaffected individuals will~     be asked to provide blood and other samples and will undergo tests to evaluate heart and lung~     function. Nonaffected individuals will include relatives of affected individuals and healthy~     nonrelated volunteers.~      Objectives:~      - To study individuals who have or are at risk for cardiovascular diseases, as well as their~     unaffected relatives and healthy volunteers.~      Eligibility:~      - Individuals between 2 and 100 years of age. Participants may be healthy volunteers,~     individuals with cardiovascular diseases, or unaffected relatives of individuals with~     cardiovascular diseases.~      Design:~        -  Participants will have some or all of the following tests, as directed by the study~          researchers:~        -  Photography of the face and full body~        -  Body measurements~        -  Radiography, including chest or limb x-rays~        -  Metabolic stress testing to study heart and muscle function~        -  Echocardiography to study heart function~        -  Magnetic resonance imaging (MRI) studies, including cardiovascular MRI, angiography, and~          contrast MRI, to study heart function and performance~        -  Computed tomography (CT) angiogram to obtain images of the heart and lungs~        -  Positron emission tomography (PET) imaging to study possible fat infiltration of the~          heart~        -  Six-minute walk test to study heart, lung, and muscle function and performance~        -  Vascular ultrasound to study blood vessel walls~        -  Blood, tissue, and other specimens will be collected for research and testing, and will~          be taken either as part of the clinical study or during surgical procedures.~        -  Follow-up studies may be performed under separate research protocols.~   "
184988|NCT01143324|"~     The aim of the study is to observe and document surgical practice and evaluate patients'~     outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF~     (Posterior Lumbar Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion)~     techniques for the treatment of the degenerative lumbar spine in a real-world patient~     population.~   "
185054|NCT01142453|"~     This was an observational, single arm, multicentric study conducted for the adjustment of~     treatment strategy and its monitoring using high-frequency and high-dosage administration of~     interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and~     safety of existing immunomodulatory basis therapy in MS subjects.~   "
184980|NCT01143441|"~     Objective:~      The primary goal of this study is to investigate the mechanism of action (MOA) of~     CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal~     of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS.~      Study population:~      Two cohorts of patients will be enrolled:~        -  Long-term daclizumab therapy cohort: Up to 15 daclizumab-treated patients with~          relapsing-remitting (RR-MS) or secondary-progressive MS (SP-MS) previously classified as~          HI-MS based on MRI/clinical criteria, who have been treated with IV daclizumab for a~          minimum of 1 year and responded to this therapy with significant (>70%) decrease in~          contrast-enhancing lesions (CEL) or stabilization/improvement of disease activity (>60%~          decrease in MS relapses and stable or improved EDSS disability score).~        -  New treatment cohort: Up to 15 HI-MS patients (RR- or SP-MS) with inadequate therapeutic~          response to first-line, FDA-approved immunomodulatory therapies for MS or who cannot,~          for any reason, be treated with first-line, FDA-approved immunomodulatory therapies for~          MS.~      Design:~      This is an open label, Phase I trial of 150 mg of daclizumab high yield process (DAC HYP)~     administered subcutaneously (SC) every 4 weeks for a total of 3 years.~      Outcome measures:~      Because the main goal of this study is to investigate the MOA of CD25-blocking therapies in~     MS, the primary outcomes are mechanistic immunological studies performed on clinical samples~     (peripheral blood mononuclear cells (PBMC), cerebrospinal fluid (CSF) cells and skin~     biopsies) derived from DAC HYP-treated patients. The secondary outcome measure is long-term~     safety and tolerability of subcutaneous DAC HYP in HI-MS patients.~   "
184981|NCT01143428|"~     Background:~      - Primary lateral sclerosis (PLS) is a disorder in which nerve cells in the brain that~     control movement degenerate. The cause of PLS is not known, but some research has suggested~     that environmental factors that produce oxidative stress trigger PLS in people who carry~     certain genes. Oxidative stress is caused when the body makes chemicals called free~     radicals faster than its natural systems can break them down. Oxidative stress can be~     triggered by exposures to chemicals related to the bodily effects of lead, smoking, alcohol~     consumption, physical activity, and psychological stress. Chemicals produced by the body~     during oxidative stress can be measured in the blood and urine. Researchers are interested in~     studying the physical, neurological, and chemical effects of PLS to better understand the~     effects of oxidative stress on the disorder.~      Objectives:~      - To study the relation of oxidative stress to the diagnosis and progression of motor neuron~     disease.~      Eligibility:~      - Individuals 20 years of age or older who have been diagnosed with PLS, and have had~     symptoms of PLS for at least 5 but not more than 8 years and been previously enrolled in~     01-N-0145 Screening: Neurologic Disorders with Muscle Stiffness~      Design:~        -  Participants will have an initial study visit and three follow-up visits. Each visit~          will require approximately 3 days of testing at the National Institutes of Health~          Clinical Center.~        -  As part of this study, participants will have the following tests and procedures:~        -  Neurological examination to test muscle strength, sensation, coordination, and reflexes,~          as well as clarity of speech~        -  Tests of memory, attention, concentration, and thinking~        -  Surveys on oxidative stress, including questions on life, mood, jobs held, and habit~        -  Electromyography to record the electrical activity of muscles~        -  Transcranial magnetic stimulation to measure electrical activity translated from their~          brain to the muscles~        -  Blood, urine, and skin biopsy samples for testing and sample collection~        -  After the initial visit, participants will have three more visits, once each in the~          following 3 years.~   "
184982|NCT01143402|"~     This randomized phase II trial studies temozolomide to see how well it works compared to~     selumetinib in treating patients with melanoma of the eye that has spread to other places in~     the body. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Selumetinib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. It is not yet known whether temozolomide is more~     effective than selumetinib in treating melanoma of the eye.~   "
184983|NCT01143389|"~     The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light~     to treat progressive keratoconus or post-refractive corneal ectasia.~   "
184984|NCT01143376|"~     The most appropriate and effective exercise interventions for weight loss remain a matter of~     continued discussion and there is a need to identify sustainable exercise programs which~     successfully promote weight loss and benefit health.~      The primary objective of this study is to determine if high-intensity intermittent sprinting~     (HIIS) produces better results in terms of reducing metabolic and cardiovascular risk~     factors, with special emphasis to fat mass loss and insulin sensitivity in healthy obese~     volunteers compared with an iso-caloric program of moderate-intensity continuous cycling~     (MICC) (control condition following the international recommendations). We will also assess~     the impact of short duration sprints (SDS) in the above factors and to understand the~     potential mechanisms behind different outcomes among training programs.~      The overall hypothesis is that HIIS will lead to a greater reduction in metabolic and~     cardiovascular risk factors compared with MICC in healthy obese volunteers and that SDS will~     produce similar improvements in cardiovascular risk factors as the longer duration HIIS~   "
184985|NCT01143363|"~     Several studies have shown that high intensity intermittent sprints (HIIS) are more effective~     than moderate intensity continuous cycling (MICC) in reducing fat mass and improving insulin~     resistance in normal weight individuals. Changes in the appetite-regulatory system in~     response to exercise are likely to explain, at least partially, the better outcome observed~     after HIIS. Unfortunately, there are no studies comparing the impact of different types of~     acute aerobic exercise on the release of appetite-regulating hormones, subjective feelings of~     appetite and subsequent energy intake (EI).~      The primary objective of this study is to investigate the effects of acute isocaloric bouts~     of HIIT and MICC or a short duration sprint, in comparison with a resting control condition,~     on the postprandial release of appetite-regulating hormones, subjective feelings of appetite~     and subsequent EI in obese individuals. The investigators hypothesize that an isocaloric~     session of HIIS will result in a better short-term appetite control compared with MICC, by~     reducing hunger feelings and subsequent food intake more than MICC and by inducing a larger~     increase in the release of satiety gut peptides compared with the MICC.~   "
184986|NCT01143350|"~     The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium~     term effectiveness of staff education as a non-pharmacological intervention to manage apathy~     in older people with a diagnosis of dementia.~        -  Primary efficacy criteria: Apathy Inventory clinician score changes~        -  Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes,~          Observation scale changes, frequency and severity of the other BPSD using the NPI,~          qualitative analysis of the nursing home staff behavioural changes~   "
184987|NCT01143337|"~     The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of~     MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses~     of Methotrexate.~   "
184989|NCT01143311|"~     The aim of this study is to analyze the differential expression of the miR transcriptome in~     the distinctive stages of the development of cutaneous squamous cell carcinoma (C-SCC). In~     this aim the investigators plan to recruit a cohort of 20 patients suffering of C-SCC and to~     collect from each of them, biopsies corresponding to i) non UV-exposed areas ii) UV-exposed~     areas, iii) actinic keratosis and iv) tumoral regions. Total RNAs will be prepared from each~     biopsy and the miRNA profiles will be characterized using a dedicated miR array.~   "
184990|NCT01143298|"~     The purpose of this phase 1 study is to determine the relative bioavailability following~     single oral dose administration of LEO 27847 solution compared to LEO 27847 tablets in~     healthy male subjects as well as to determine the effect of food on the single oral dose~     pharmacokinetics of LEO 27847 tablets in healthy male subjects.~   "
184991|NCT01143285|"~     Description of active nutritional support: Early and active nutritional support is mainly~     concerned with maintaining protein and energy intake levels despite chemotherapy. A part-time~     nutritionist will be assigned to each research centre. She will cover active nutritional~     support during a one-hour consultation and assist the investigating oncologist in filling out~     the e-CRF data. A two-day meeting prior to the beginning of the study will enable the~     standardization of active nutritional support strategy across all research centres:~        -  The nutritionist will explain the consequences of the side effects of chemotherapy on~          appetite levels and nutritional status.~        -  Spontaneous oral intake and eating habits will be assessed based on a qualitative and~          quantitative 3-day food record.~        -  Then the nutritionist will explain to patients how to adapt their diet (fortification,~          portion control etc.) according to personal preferences and dietary habits, appetite~          fluctuation and side effects.~        -  A booklet containing an overview of the nutritional counsel, recipe ideas, an example of~          a daily menu, energy equivalence tables and specific diet and hygiene tips for each~          possible side effects of chemotherapy will be given to all patients.~        -  During each consultation, patients will be weighed, appetite and food intake will be~          evaluated (24-hour record except for prospective 3-day record of V0, V3, V6, V9, V12,~          V13 and V14 consultations), chemotherapy side effects will be recorded and nutritional~          counsel will be adapted to each patient's individual situation. In case of decrease in~          food intake and/or weight loss, a protein- and energy-rich oral supplement will be~          given.~      In both groups, if a patient exhibits signs of malnutrition (weight loss >5% over a one-month~     period or > 10% in total) and/or food intake less than 50% of estimated daily requirements,~     an oral supplement will be given after approval of the oncologist. If this measure is~     insufficient, artificial nutrition (enteral or parenteral) will be considered.~   "
184992|NCT01143272|"~     When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences~     may be grave for the patient. Thus far, no preventive measure is available. The investigators~     hypothesize that the apathogenic yeast Saccharomyces boulardii, administered in addition to~     the antibiotic, may prevent episodes of diarrhoea or may lead to less pronounced diarrhoea.~     To test this hypothesis, the investigators are carrying out a clinical trial in 1520 adult~     patients in several hospitals.~   "
184993|NCT01143259|"~     The purpose of this study is to determine if the addition of alvimopan to our care process~     model for colon resection patients will decrease length of stay. The care process model is a~     combination of optimal IV fluid management, early feeding, early ambulation, patient~     education, and pain management.~   "
184994|NCT01143246|"~     This study is designed to evaluate the efficacy and safety of intravenous Lucassin®~     (terlipressin) versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in~     subjects receiving standard of care albumin therapy.~   "
184995|NCT01143233|"~     The study is conducted to examine the suitability of partially respectively extensively~     hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term~     infants.~      Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with~     modified protein content is non inferior compared to a standard infant formula based on a~     Protein hyrolysate in respect to proper growth of healthy, term infants within the first four~     month of life.~      4-year follow-up (without further Intervention) will focus on body composition and allergic~     predisposition.~   "
184996|NCT01143220|"~     The purpose of this clinical investigation is to assess the programming behavior of the~     physicians in the patient cohort. Furthermore, the acceptance level of specific programming~     recommendations based on the patient's clinical needs and primary indications will be~     evaluated by comparing parameters determined by the feature IBP to daily life programming~     chosen by physicians.~   "
184997|NCT01143207|"~     A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is~     adequate for effective contraception~   "
184998|NCT01143194|"~     The purpose of this study is to investigate the effects of the dietary supplement oréVida™~     (active ingredient on the basis of a culinary herb)administered twice daily in an acute study~     on an improvement in vigilance, attention, concentration, memory and mood in 45 healthy men~     and pre-menopausal women, aged 35-50 years, inclusive.~      oréVida™ is considered a dietary supplement, and therefore it is not an approved drug by the~     Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug~     Administration does not strictly regulate herbs and dietary supplements. We do not claim that~     this supplement is meant to treat any ailment.~   "
184999|NCT01143181|"~     CMX001 is an orally administered lipid conjugate of the synthetic nucleotide analog cidofovir~     (CDV). The conjugate is believed to be absorbed in the small intestine then delivered to~     target organs throughout the body where it crosses cell membranes by facilitated and passive~     diffusion. Inside the cell, CMX001 is cleaved by intracellular phospholipases to release CDV~     which is converted to the active antiviral agent, CDV-diphosphate (CDV-PP), by intracellular~     anabolic kinases. Adults and adolescents, regardless of viral infection/disease, will have a~     maximum weekly dose of 200 mg i.e., 200 mg once weekly OR 100 mg twice weekly; not to exceed~     4mg/kg total weekly dose. Pediatric subjects (< 12 years), regardless of viral~     infection/disease, will have a maximum weekly dose of 4 mg/kg i.e., 4 mg/kg once weekly OR 2~     mg/kg twice weekly.~   "
185000|NCT01143168|"~     The purpose of this study is to evaluate the feasibility, efficacy and safety of~     transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal~     stem cells for patients with type 1 diabetes mellitus~   "
185013|NCT01142986|"~     This research is being done to evaluate the effectiveness of three different treatment~     strategies for helping subjects begin and adjust to methadone maintenance treatment at~     Addiction Treatment Services (ATS). Subjects will be randomly assigned to one of three~     treatment conditions: 1) Voucher-Based Stepped Care (VBSC) induction, 2) Low-threshold~     Stepped Care (LTSC) induction, or 3) Routine Stepped Care (RSC) induction. It is hypothesized~     that subjects in both the VBSC and LTSC condition will remain in treatment longer than~     subjects in the RSC condition. In addition, it is hypothesized that VBSC and LTSC subjects~     will have less drug-positive urine samples and will report less infectious disease risk~     behaviors than RSC subjects.~   "
185001|NCT01143155|"~     Although failure and mortality are the most relevant outcomes in patients with~     Community-acquired Pneumonia (CAP), there is little discussion in the literature on their~     incidence and etiology. A pathophysiological approach has been recently developed and used to~     evaluate clinical failure in CAP patients. Clinical failure has been analyzed as related~     versus unrelated to CAP, considering the role that the pulmonary infection and the~     inflammatory response played in the development of this outcome. Cardiac events were~     identified as triggers of clinical failures in a significant percentage of CAP patients. The~     development of cardiovascular events have been also identified in CAP patients both on~     admission to the hospital and during hospitalization. However, data on this topic belong to~     studies evaluating only selected populations of veteran patients with CAP. Understanding~     clinical failure, as well as cardiovascular events in hospitalized patients with CAP would be~     useful in order to prevent complications during the hospitalization, to develop new treatment~     modalities and, thus, to improve outcomes.~      The objectives of this international, multicenter, observational, prospective cohort study~     will be: 1) To define incidence, timing, etiology and risk factors of clinical failure,~     related vs. unrelated to CAP, in hospitalized patients with CAP; 2) To define incidence,~     timing, and risk factors for cardiovascular events either on hospital admission or during~     hospitalization in hospitalized patients with CAP.Consecutive adult patients hospitalized for~     CAP in acute care hospitals in Europe and US will be enrolled. Daily clinical evaluations.~     Demographics, history, clinical, radiological, and antibiotic therapy data will be recorded,~     as well as serum, urinary and respiratory samples will be collected both on admission and~     during hospitalization from consenting individuals. Patients will be classified as having a~     CAP-related versus CAP-unrelated failure, according to a pathophysiological classification.~     Patients will be also classified as having or not a cardiovascular event either on admission~     or during hospitalization.The following outcomes will be measured:~      1) Incidence, timing, etiology and risk factors of clinical failure related vs. unrelated to~     CAP; 2) Incidence, timing and risk factors of cardiovascular events; 3)time to clinical~     stability, length of hospital stay, mortality at hospital discharge, and mortality at 30 and~     180 days.~   "
185002|NCT01143142|"~     The goal of this study is to determine whether a two-page print brochure that delivers~     individually tailored educational messages about the Human papillomavirus (HPV) vaccine~     increases HPV vaccine-hesitant mothers' intentions to have their adolescent daughters~     vaccinated against HPV.~   "
185003|NCT01143129|"~     The DExamethasone for Cardiac Surgery - Postoperative New-onset Atrial Fibrillation~     (DECS-PNAF) project described in this protocol aims to elucidate how corticosteroids protect~     cardiac surgical patients from Postoperative New-onset Atrial Fibrillation (PNAF). Patients~     will be randomized to receive either a single high dose of dexamethasone or a placebo.~     Continuous ECG-monitoring, echocardiography and biochemical and genomic analyses will be used~     to investigate the mechanisms responsible for the known protective effect of corticosteroids~     in the development of PNAF.~   "
185004|NCT01143103|"~     The present study aims to compare the efficiency of respiratory therapy with cough assist and~     the efficiency of usual respiratory therapy in intensive care patients suffering of~     neurologic disorder and cough ineffectiveness. The investigators hypothesis is that cough~     assist is more efficient than usual respiratory care in this group of patients.~   "
185005|NCT01143090|"~     Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a~     potential new antipsychotic treatment for patients with schizophrenia. Switching between~     antipsychotic medications is common in the treatment of schizophrenia. The purpose of this~     study is to characterize the long-term safety and tolerability of lurasidone in subjects with~     schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects~     completing the core study (D1050289-NCT01143077).~   "
185006|NCT01143077|"~     Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a~     potential new antipsychotic treatment for patients with schizophrenia. Switching between~     antipsychotic medications is common in the treatment of schizophrenia. The current study is~     designed to evaluate the effectiveness, safety, and tolerability of switching clinically~     stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their~     preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.~   "
185007|NCT01143064|"~     The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the~     injury for a total of 120 hours to severe traumatic brain injury patients improves their~     recovery.~   "
185008|NCT01143051|"~     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine~     Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers.~     Safety of E004 will also be evaluated, under augmented dose conditions.~   "
185009|NCT01143038|"~     The purpose of this study is to describe the number of months with a platelet response over a~     12 month treatment period and to describe ITP remission rates in adults with ITP receiving~     romiplostim.~   "
185010|NCT01143025|"~     The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 50 mg,~     100 mg or 150 mg may prevent the use of morphine during the first day after laparoscopic~     cholecystectomy.~   "
185011|NCT01143012|"~     The objective of this study is to determine whether group educational visits improve the~     quality of life of patients referred to the Dermatology Clinic. Secondary outcomes will be to~     determine whether group educational visits influences other key elements of patient care such~     as topical steroid usage, disease exacerbations, emergency visits, and phone calls to the~     office. Lastly, the investigators hope to evaluate which aspects of the educational visit~     were found to be the most helpful to families caring for children with atopic dermatitis~     (AD). Patients will be new atopic dermatitis referrals to OHSU dermatology and pediatric~     dermatology clinics. All consecutive patients with such appointments during a three month~     time period will be screened for participation in the study. Parents will be recruited via~     telephone. In the intervention group, parents will be invited to participate in a group~     education visit prior to their first appointment with a dermatologist. All parents in the~     study will fill out questionnaires. The children involved in the study will be assigned an~     eczema severity score during their routine visits, but this will be incorporated into the~     regular clinic assessment. The Childhood Atopic Dermatitis Impact Scale (CADIS) assesses the~     quality of life in households with children who have atopic dermatitis. The Eczema Area and~     Severity Index (EASI) measures the extent and severity of the patient's atopic dermatitis.~     The change in CADIS scores will be analyzed to determine if there is a more significant~     improvement in quality of life for the group in which parents receive the group eczema~     education visit.~   "
185012|NCT01142999|"~     The purpose of this protocol is to determine the feasibility of doing larger follow-up~     studies examining whether emollients used from birth can prevent eczema in high-risk babies~     and to help investigators find out if emollients (moisturizing skin creams) used from birth~     can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth~     using emollients will prevent or delay the onset of eczema, especially in predisposed~     infants.~   "
185014|NCT01142973|"~     Study Type: Observational Study Design: Observational Model: Defined Population Observational~     Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective~   "
185015|NCT01142960|"~     With the rapid growing aging population, age-related eye diseases including cataract are~     becoming more prevalent. The demand for cataract surgery and post-surgical care posed~     enormous financial burdens to the government.~      Lycium barbarum contains lutein and zeaxanthin which can filter the phototoxic blue light and~     neutralize the reactive oxygen species, thus provide a protective effect against cataract~     formation.~      This study aims to determine the effects of Lycium barbarum Supplements on the progression of~     senile cataract in Hong Kong Chinese elderly.~   "
185016|NCT01142947|"~     Inhaled corticosteroids (ICS) are considered first-line treatment for persistent asthma, yet~     little is known about the genetic factors that influence response to this therapy. This study~     seeks to quantify response to ICS therapy in African American and white patients, as well as~     look for genetic markers that predict treatment response.~   "
185017|NCT01142934|"~     TegaCHG is a multicentric randomized study aimed at evaluating the possibility that the use~     of TegaDerm CHG dressing may reduce the incidence of catheter related blood stream infections~     (CRBSI). It implies the comparison between the incidence of CRBSI in patients with central~     venous catheter dressed with TegaDerm without chlorhexidine gluconate (CHG) and with CHG. The~     primary endpoint is the occurrence of CRBSI and the secondary endpoints are:~      catheter colonization (growth of microbes from the culture of catheter tip, > 15 CFU~     according to semi-quantitative method or > 1000 CFU according to quantitative method);~     incidence of catheter exit site infection; occurrence of catheter related infections/sepsis~     or other severe infection-related complications; safety profile evaluation: occurrence of~     hypersensitivity to the dressing on the basis of local objectivity (erythema, edema, other)~     or on that of patient symptoms (itch, burning sensation); relating to the device performance:~     incidence of high/medium/low dressing edge lift, ability to visualize the catheter insertion~     site, easiness of removal, easiness of dressing application; incidence of unscheduled~     dressing change. The study hypothesis implies that the use of slow release device containing~     chlorhexidine may decrease the incidence of CRBSI. This has already been showed for~     chlorhexidine impregnated sponges. Scope of the study is to verify if this property is also~     true for TegaDerm CHG,which is a new chlorhexidine-releasing dressing in which the medication~     is directly released by an integrated transparent gel pad, so that the catheter exit site~     remains visible and easy to inspect without removing the dressing.~   "
185018|NCT01142921|"~     The aim of this study is to determine the average patency period of the new anti-reflux~     biliary stent on patients with malignant bile duct strictures and to determine if this stent~     remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum~     biliary stent.~   "
185019|NCT01142908|"~     Cardiovascular disease (CVD) is the leading cause of death in the United States; more than~     80% of veterans have > 2 risk factors for CVD. Our study is one of the first to examine the~     implementation of a tailored behavioral/educational self-management intervention in primary~     care clinics designed to improve CVD risk. The proposed study could result in a leap forward~     in CVD risk management among veterans for several reasons: 1) ) This is a novel extension of~     our previous interventions that have demonstrated improved BP, now designed to address~     multiple chronic conditions contributing to CVD risk, particularly hyperlipidemia and~     diabetes. The study focuses on both multiple CVD-related risk factor management and~     medication management 2) The intervention is multi-behavioral; it addresses patients' various~     health behavior (e.g., smoking, diet, and medication adherence). 3) Components of the~     intervention will include specific recommendations and transportability of intervention~     application software and tracking packages that will allow clinic managers to implement the~     intervention if it is effective.~   "
185020|NCT01142895|"~     The purpose of this simulated useability study is to demonstrate the user interface and~     software design mitigate potential safety concerns.~   "
185021|NCT01142882|"~     This study will evaluate the comparative effectiveness and cost-effectiveness of a~     customized, interactive web-based HIV, sexually transmitted infections (STI) and hepatitis~     prevention intervention as compared to a traditional, educator-delivered prevention~     intervention. Both interventions will be offered to youth enrolled in outpatient,~     community-based substance abuse treatment at our collaborating treatment facilities. Outcomes~     to be measured include accurate HIV/disease prevention knowledge, intentions to engage in~     safer sex, actual HIV risk behavior, attitudes toward safer sex and self-reported substance~     use. The web-delivered intervention under evaluation has the potential to deliver~     evidence-based content at low cost without increasing demands on treatment staff time or~     training needs.~   "
185022|NCT01142869|"~     The aim of this prospective, observational, multicenter, post-marketing study is to evaluate~     the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based~     chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of~     head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres~     across India.~   "
185023|NCT01142856|"~     The purpose of this study is to determine the safety of injecting mesenchymal stem cells~     through intraspinal delivery for the treatment of ALS.~   "
185024|NCT01142843|"~     Mouthwash based on medicinal plants and propolis can be easily found in the Brazilian market~     even if it has not been tested in reliable clinical trials on its efficacy or possible~     unpleasant side effects like the ones which alter the hard and soft oral tissues. The aim of~     this study was to obtain preliminary evidence of efficacy of an alcohol-free mouthwash~     containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis. Were chosen~     twenty-five subjects that are UFMG employees and individuals who would begin treatment on an~     extension project called Supportive Periodontal Therapy at the Faculty of Dentistry of~     Federal University of Minas Gerais, Belo Horizonte, from August to December 2009. The~     subjects went through a dental prophylaxis before starting rinse. They were then instructed~     to rinse twice a day for a minute, immediately after brushing (morning and night), using the~     10 ml of the MGP 5%. After 45 and 90 days using the product the individuals returned for a~     clinical evaluation which considered changes in the soft and hard oral tissues and involved~     collecting plaque and gingivitis indexes. On their last appointment the subjects answered a~     questionnaire about their level of appreciation and acceptability of the mouthwash.~     Compliance with the treatment was also evaluated through an attendance form. For the~     statistic analysis we used BioEstat 4.0 and Excel 2007.~   "
185026|NCT01142817|"~     This study will investigate the prevalence and extent of both metabolic and psychosocial~     changes associated with the menopause transition over 1 year among women with HIV compared to~     women without HIV of similar age, weight, menstrual status, and ethnic background. It is~     hypothesized that HIV positive women will demonstrate increased abdominal fat, abnormal~     cholesterol and blood sugar levels, reduced bone density, and greater psychosocial challenges~     than HIV negative women during the menopause transition.~   "
185027|NCT01142804|"~     The investigators propose a randomized controlled trial based on the Social Networks for~     Activity (SNAP) Model to evaluate: (1) the effectiveness of an internet-based fitness walking~     program delivered to patients with risk factors for cardiovascular disease and stroke; and~     (2) the contribution of social support networks to enhancing the effectiveness of the~     internet-based fitness walking program. The investigators will recruit 308 patients who are~     sedentary and have risk factors for cardiovascular disease and randomly assign them to one of~     the following groups: 1. Internet-based fitness walking program (WalkLink); 2. Internet-based~     fitness walking program plus additional social network intervention (WalkLink+); and 3.~     Minimal treatment control.~      The primary specific aims of this study are to:~        1. Evaluate the effects of WalkLink and WalkLink+ relative to a minimal treatment control~          group on change in: physical activity, aerobic fitness, blood pressure, body~          composition, and body mass index (BMI), from baseline to posttest, and at 6-month~          follow-up.~        2. Compare the differential effectiveness of WalkLink+ to WalkLink on change in: physical~          activity, aerobic fitness, blood pressure, body composition and BMI from baseline to~          posttest, and at 6-month follow-up.~        3. Evaluate the mediator and moderator effects of selected individual-level self-management~          skills (goal setting, planning, self-monitoring), social support variables (number of~          activity partners, social cues for walking, social praise/reinforcement), and~          physical-ecological variables (neighborhood walkability, physical cues for walking) on~          WalkLink and WalkLink+ treatment outcomes.~   "
185028|NCT01142791|"~     The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of~     uterine fibroids using the enhanced sonication techniques, based on the current~     commercially-approved treatment guidelines. Treatment may include up to 100% of individual~     fibroid volume, within established serosal and sacral treatment margins.~      The Enhanced sonication is one of the various sonication modes that may lead to increased~     thermal dose volume of each sonication without additional safety risks. This is an additional~     treatment tool available in the ExAblate system for the treatment of uterine fibroids.~      The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE~     study. FDA granted approval of Enhanced Sonication with the requirement to perform a~     post-approval study to collect additional safety data when treating up to 100% of individual~     fibroid volume.~   "
185029|NCT01142778|"~     This randomized study will assess the effect of adding bevacizumab to trastuzumab plus~     docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth~     factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel~     once every 3 weeks, participants with a response (change in standard uptake value [SUV]) of~     less than (<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a~     2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram [mg/kg]) and~     docetaxel (100 milligrams per square meter [mg/m^2]) with or without bevacizumab (15 mg/kg).~     Participants with a response of greater than or equal to (>/=) 70% will receive trastuzumab~     plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7,~     and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6~     weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive~     a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery~     during 4-6 weeks, according to site's standard practice) with or without hormonal therapy~     (mandatory if positive hormone receptors). Participants will be followed for up to 5 years~     from start of neoadjuvant treatment.~   "
185030|NCT01142765|"~     This study aims to test the safety and efficacy of six new malaria vaccines - AdCh63 AMA1,~     MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP & MVA ME-TRAP. These vaccines consist of~     inactivated viruses which have been modified − so they cannot reproduce (replicate) in~     humans, and also to include genetic material (genes) for malaria proteins which are expressed~     by the malaria parasite during both liver and blood stage infection. The vaccines are~     designed to stimulate an immune response to these malaria proteins (immunogenicity describes~     the nature and magnitude of this immune response) and thus provide protection against malaria~     infection. The protective efficacy of vaccines will be evaluated by challenging a small~     number of volunteers who have received the vaccines with malaria infection from the bites of~     infected mosquitos(sporozoite challenge).~   "
185031|NCT01142752|"~     The prevalence of preterm birth is not decreasing in the last decades despite of improving~     health care. Intrauterine infections are important in the etiology of preterm birth but the~     interconnection of systemic inflammation and preterm birth is not clear. Mechanisms of~     preterm birth should be assessed as preterm birth is the major risk factor for morbidity and~     mortality during birth, thus being important for the individual and regarding health costs.~      No interventions will be carried out in this study.~      Hypotheses:~        1. There is a common etiology between oral and vaginal inflammation~        2. Bacterial species are similar in vagina and oral cavity~        3. There are similar oral and systemic immune reactions which provoke preterm birth~        4. Inflammatory markers are found in pregnant women at risk and get back to normal post~          partum In this matched case control study of pregnant women local, systemic and oral~          inflammation markers and bacterial load are assessed to find out interconnections~          between these body compartments to allow for explanation of the etiology of preterm~          birth.~   "
185055|NCT01142440|"~     Our study is designed as an interventional prospective longitudinal study which examines the~     Israeli defense force personnel. The population of our study is composed out of the IDF~     personnel which will be randomly be subdivided into 2 different groups - one will be noted as~     the intervention group and the other will function as a control group. Each participant will~     be monitored for a period of 18 months.~   "
185056|NCT01142427|"~     This research trial studies a risk-based classification system for patients with newly~     diagnosed acute lymphoblastic leukemia. Gathering health information about patients with~     acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best~     treatment.~   "
185032|NCT01142739|"~     Levodopa-induced dyskinesia severely limits the use of levodopa in Parkinson's disease and~     constitutes a debilitating complication of dopaminergic treatment in late stage. Among~     several neurobiological mechanisms identified so far, the investigators have established in~     experimental models the key role of D1 receptor hypersensitivity and aRas-ERK signalling~     pathway. As the very same dopamine receptor machinery and the Ras-ERK pathway are present in~     blood lymphocytes, the investigators wish to test the hypothesis that the level of ERK~     phosphorylation in lymphocytes is a biomarker of levodopa-induced dyskinesia in Parkinson's~     Disease.~      The study will be performed in dyskinetic levodopa-treated patients and non-Parkinson's~     Disease controls. Blood sampling off and on levodopa treatment (1 hour post-dose), as~     well as clinical data collection will be done during a scheduled pre-op work-up (deep brain~     stimulation). Subsequently, suspended lymphocytes from blood samples will be immunolabelled~     using an anti-pERK antibody and mean fluorescence intensity and percent of labelled~     lymphocytes will be assessed by flow cytometry. Additionally, plasma and urine samples will~     be collected on et off for dosage of dopamine. The motor effect of levodopa will be~     assessed through UPRSIII rating scale and eye movement (saccades) speed by non-invasive~     oculometric recordings.~   "
185033|NCT01142726|"~     The primary purpose of the protocol is to demonstrate the ability of abatacept plus~     methotrexate to induce remission in patients with very early rheumatoid arthritis after 12~     months of treatment and to maintain remission following 6 months of drug withdrawal.~   "
185034|NCT01142713|"~     Radiotherapy has a significant impact on local control, disease free survival and overall~     survival in patients with rectal cancer T2, N1, M0 and T3-4, any N, M0. Treatment is~     accompanied by side effects, mainly due to the inclusion of the small bowel and urinary~     bladder in the treatment fields.~      Two major modalities have been pursued to reduce the volume of small intestine and urinary~     bladder in treatment volume. One is a surgical procedure, such as absorbable mesh. These~     procedures have failed implementation in daily clinical practice. The second modality aims to~     save the small intestine and urinary bladder from the toxicity of radiotherapy by modulating~     the radiotherapy planning procedure. Using the belly board and changing the standard position~     from supine to prone could achieve this aim; in part due to gravitational displacement of the~     bowel. Several studies have evaluated the impact of positioning and use of belly board in~     patients receiving pelvis irradiation for rectal cancer. The results are inconclusive, but~     the prone position with belly board appears promising.~      This study carefully evaluates the impact of patient's positioning and belly board on dose~     volume histogram of small bowel and urinary bladder~   "
185035|NCT01142700|"~     Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is~     safe, well tolerated, and has sufficient antiviral activity to progress to late stage~     clinical trials when combined with pegIFNα/RBV for treatment of chronically infected~     hepatitis C virus genotype 1 treatment-naive subjects.~   "
185036|NCT01142687|"~     The study is designed to determine the effects of a non-pungent supplement from sweet chilli~     pepper on resting metabolic rate and diet-induced thermogenesis (DIT) after a period of very~     low calorie intake over 4 weeks.~   "
185037|NCT01142674|"~     The designed study follows up the retrospective previous one by the International T-cell~     Non-Hodgkin's Lymphoma Study Group (International Peripheral T-Cell Lymphoma Project).~      It is designed as a prospective collection of information potentially useful to predict the~     prognosis of newly diagnosed patients with the more frequent subtypes of Peripheral T-cell~     lymphoma (Peripheral T-cell lymphoma unspecified and Angioimmunoblastic T-cell lymphoma) and~     to better define clinical characteristics and outcome of the more uncommon subtypes~   "
185038|NCT01142661|"~     The purpose of this study is to provide eribulin to patients with advanced breast cancer who~     have no other treatment options and therapy is requested by an Investigator.~   "
185039|NCT01142648|"~     According to our experience, electroencephalogram-based indices of anaesthetic state show~     elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade).~     This can be due to altered anaesthetic state, or some kind of artefact. In this study, the~     phenomenon is evaluated in detail.~   "
185040|NCT01142635|"~     Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors~     to show misleadingly high values. The investigators want to investigate whether this EMG~     activity can be visually seen on the anaesthesia monitor.~   "
185041|NCT01142622|"~     The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg~     may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.~   "
185042|NCT01142609|"~     This research is being done to compare the effectiveness of standard on-site, in-person~     counseling with Internet web-based videoconferencing (e-therapy) in drug-dependent patients~     in opioid-agonist treatment programs. The study is looking to see if there are any~     differences in satisfaction or in treatment outcome if counseling sessions are given by~     e-therapy compared to standard, in-person counseling given in the clinic. The e-therapy~     happens in real time- it works very much like standard therapy in the clinic except that the~     patient is in his or her own home (or other convenient location outside the clinic) and talks~     to and sees the therapist through an Internet connection on the computer (the therapist will~     usually be at the clinic).~   "
185043|NCT01142596|"~     This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in~     participants with schizophrenia. The first six weeks of the study will be double-blind and~     the remainder of the study will be open label. Participants in this study consist of~     participants who have completed the preceding short-term study (P06124 [NCT01098110]), who~     meet the inclusion criteria and wish to continue receiving study drug, and whom the~     investigators have deemed eligible for study participation. Participants who were on placebo~     twice daily (BID) in core trial P06124 will get placebo for the first 2 weeks then 5 mg~     asenapine BID for the next 4 weeks of double blind treatment, and will be re-randomized after~     week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 5 mg~     BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or~     asenapine 10 mg BID. Participants who were on asenapine 10 mg BID in core trial P06124 will~     be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. After~     re-randomization, drug will be administered open-label for 46 weeks. During this period dose~     is flexible can be adjusted using dose options of 5 and 10 mg BID for efficacy and~     tolerability.~   "
185044|NCT01142583|"~     The Canadian Multiple Sclerosis Working Group (CMSWG) has developed practical recommendations~     on how neurologists can assess the status of subjects on disease modifying drugs (DMDs) and~     decide when it may be necessary to modify treatment in order to optimize outcomes. These~     recommendations are based on relapses, disease progression as measured by the Expanded~     Disability Status Scale (EDSS) or EDSS progression, and magnetic resonance imaging (MRI)~     outcomes. The CMSWG agreed to compare post-treatment relapse rates and severity to baseline~     rates and severity in each individual subject. The recommended minimum baseline reference~     time frame needed to assess relapse rate was 2 years prior to treatment initiation. The~     objective and prospective relapse data should be ideally collected during this reference~     period. The CMSWG recommended that the following should be taken into consideration when~     assessing relapse severity: the effect of the relapse on activities of daily living (ADL),~     the type and number of systems involved (i.e., relapses that are polysymptomatic or that~     affect the cerebellar/motor systems tend to be more severe), and whether or not a course of~     corticosteroids was required. The CMSWG also recommended that, prior to considering treatment~     modification on the basis of progression in disability, progression should be confirmed at 6~     months.~      The CMSWG's Treatment Optimization Recommendations (TORs) have been retrospectively applied~     to the 4 year data set from the PRISMS study. Applying the model to subjects after their~     first year on therapy allowed for accurate prediction of continued disease activity in the~     form of relapses in the majority of subjects who actually experienced ongoing attacks. The~     model was less effective in predicting disability progression, but this may well have been~     due to the low numbers of subjects on treatment progressing over the study period. This~     observational study used the TOR model to identify subjects as either candidates for therapy~     optimization or as candidates to maintain current therapy. All subjects were then followed~     prospectively until re- assessment will be done with this model.~   "
185045|NCT01142570|"~     This is a single-center, prospective, randomized, comparative, double-blind controlled~     clinical study intended to establish 1) the optimal method of determining calorie~     requirements and 2) the optimal amount of protein supply in chronically ventilated patients.~   "
185046|NCT01142557|"~     The aim of this case series was to document the effectiveness and compatibility of Rebif 44~     or 22 µg in the therapy of the chronic multiple sclerosis (MS) under practical conditions on~     a large collection of subjects. In addition, the side effects possibly occurring in the~     initial phase of therapy and satisfaction of the subject as well as the treating doctor was~     also documented.~   "
185047|NCT01142544|"~     Acute lung injury in children is a syndrome of rapid onset of acute respiratory failure and~     require admission into intensive care units (ICU) for advanced life support. There are almost~     no information on epidemiology of acute lung injury. Published studies do not have~     information for an entire year and none of them have evaluated the degree of oxygenation~     failure under standard ventilator settings. The investigators will perform a 1-year~     prospective audit of all patients admitted with acute lung injury in a network of pediatric~     ICUs in Spain.~   "
185048|NCT01142531|"~     CT studies considering bronchial dimensions in chronic obstructive pulmonary disease (COPD)~     were conducted without control of bronchodilation. Some data however suggest that total lung~     capacity (CT scan is performed after full inspiration) is increased in individuals affected~     by chronic or spontaneous bronchoconstriction and may decrease after bronchodilatation.~     Furthermore, no study has assessed the effect of bronchodilation on CT scans parameters~     reflecting airway remodelling and emphysema extent in COPD patients.~      This is a prospective study whose purpose is to assess the effect of bronchodilation on lung~     CT scan and pulmonary function testing (PFT) in COPD patients.~   "
185049|NCT01142518|"~     This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study to~     investigate whether baseline treatment with high-dose interferon beta 1a (Rebif 44 μg x 3 ),~     administered at a high frequency, leads to maintenance of stabilisation of the course of the~     disease in MS subjects previously treated with mitoxantrone. The previous mitoxantrone~     treatment of the included MS subjects was conducted in the course of a so-called escalation~     according to the immunomodulatory escalation treatment plan. An additional important aspect~     of the problem was the collection of safety and tolerance data during the observation phase.~   "
185050|NCT01142505|"~     The clinical aim of this trial is to assess whether intermittent montelukast is an effective~     treatment strategy in preschool wheeze. The mechanisms aim of the trial is to determine~     whether there is a genetically highly-responsive subgroup of children. In designing this~     trial the investigators have incorporated several novel aspects. First, parents will be able~     to adjust the use of oral montelukast to their child's symptoms. This allows the~     investigators to recruit both episodic and multi trigger patterns of preschool wheeze -~     and control for any change in wheeze pattern during the trial. Second, before the~     investigators issue the trial medication, the investigators will assess children's~     leukotriene genes, focusing primarily on a gene called ALOX5. This ALOX5 stratification~     step will ensure that an equal number of potentially treatment-responsive children receive~     the active drug (montelukast) and the dummy medicine - and the equal numbers will help the~     investigators to assess the role of ALOX5. For the trial, the investigators will first~     recruit 1,300 children with a history of preschool wheeze, then divide them into the group~     with responsive and less responsive genes by their ALOX5 status. The investigators will~     then issue parents with the trial medication; 50% will be given montelukast and 50% will be~     given dummy medication. Parents will start the trial medication whenever their child develops~     a cold, and stop the medication when wheeze resolve. Parents will also be able to give the~     trial medication for wheeze between colds. Over the 12 month trial period, the investigators~     will assess the number of unscheduled attendances to a medical practitioner for wheeze for~     each child. At the end of the trial, the investigators will determine whether montelukast is~     effective then whether there is a difference in response to montelukast between the 2 ALOX5~     gene groups.~      At the same time, the investigators will measure many other genes that may influence response~     to montelukast, as well as the amount of leukotrienes that are excreted in the urine before~     and during attacks. Using these results, the investigators will be able to both inform~     national treatment policy, and develop new concepts on the mechanism of preschool wheeze that~     will inform the development of new therapies. Since children will continue to receive~     normal inhaled therapy, there are no ethical issues in giving a dummy medicine to half of~     the 1300 children to be recruited. The study will be the largest trial in wheezy preschool~     children to date, and may open up genetic testing in preschool wheeze.~   "
185051|NCT01142492|"~     This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study on~     the extent to which subject compliance is influenced by use of a variable titration regimen~     at the start of treatment of relapsing MS with Rebif.~   "
185052|NCT01142479|"~     Many breast cancer patients will taking Chinese herbal medicine during receiving~     radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula~     (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the~     investigators designed this double blind and controlled trial to evaluate whether TPE-1 have~     the effects for leukopenia and cancer-related fatigue in breast cancer patients with~     radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also~     designed to evaluate the safety when patients taking this formula.~   "
185053|NCT01142466|"~     In the course of therapy escalation, the multiple sclerosis (MS) subjects with high activity~     of disease receive mainly mitoxantrone. The duration of therapy is limited because of a~     cumulative dose for life (140 mg/m^2 body surface area). In practice lower doses of~     mitoxantrone (60-120 mg/m^2 body surface area) are being used. The specific reason for this~     limited total dose are potential cardiotoxic side effects of mitoxantrone. Once this~     cumulative dose of mitoxantrone is reached and the subject becomes stable, there is the~     question for subsequent therapy. A possibility at this time, is the so-called~     de-escalation, therefore reducing the subject back to immunomodulating basic treatment.~      The target of this open-label, randomised, multicentric, comparative, parallel-group study~     was to inquire systematically into the use and course of basic therapy with Rebif 44 mcg~     thrice weekly (tiw) for a larger number of subjects.~   "
185057|NCT01142414|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Monoclonal antibodies, such as~     panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. It is not yet known whether chemotherapy given together with radiation~     therapy is more effective with or without panitumumab in treating patients with advanced~     cancer of the hypopharynx, oropharynx, larynx, or oral cavity.~      PURPOSE: This randomized phase III trial is studying chemotherapy given together with~     radiation therapy to see how well it works compared with chemotherapy and radiation therapy~     given together with panitumumab in treating patients who have undergone surgery for advanced~     hypopharyngeal cancer, oropharyngeal cancer, laryngeal cancer, or oral cavity cancer at high~     risk of recurrence.~   "
185058|NCT01142401|"~     This randomized phase II trial studies how well fulvestrant works with or without bortezomib~     in treating patients with estrogen receptor positive breast cancer that has spread to other~     places in the body and cannot be removed by surgery. Estrogen can cause the growth of breast~     cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the~     amount of estrogen the body makes. Bortezomib may stop the growth of breast cancer cells by~     blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.~     It is not yet known whether fulvestrant is more effective with or without bortezomib in~     treating breast cancer.~   "
185059|NCT01142388|"~     This randomized phase II trial studies how well paclitaxel with or without cixutumumab works~     in treating patients with esophageal cancer or gastroesophageal junction cancer that has~     spread to other places in the body (metastatic). Drugs used in chemotherapy, such as~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may~     kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving~     paclitaxel with or without cixutumumab may kill more tumor cells.~   "
185060|NCT01142375|"~     Acute leukemias are commonly seen in elderly and have no effective therapy. In recent years,~     small molecule inhibitors have shown a tremendous promise in cancer treatment such as chronic~     myeloid leukemia and lung cancer. Thus, in this proposal, we intend to use our novel patented~     indole compound to conjugated with hydroxamic acid in histone deacetylases inhibitor,~     suberoylanilide hydroxamic acid and further modify its structure to generate novel~     small-molecule anticancer compounds. By screening acute leukemic cell lines, we will look for~     compounds that have shown potential for future drug development. In our preliminary studies,~     we have identified a novel compound, MPT0E001, to have marked growth inhibitory activity,~     induce apoptosis and downregulate c-Myc protein level. We intend to use MPT0E001 as a basis~     to develop novel compounds and test them in multiple leukemic cell lines and primary leukemia~     samples (Specific aim 1) and identify the mechanisms for downregulation of c-Myc and other~     pathways such as NF-kappaB and Akt (Specific aim 2). Once we have identified the lead~     compounds, we will use murine model to assess the acute toxicity profiles in different dose~     ranges and examine the effects of blood counts and vital organs. After toxicity study, we~     will test the lead compounds using in vivo xenogenic murine model using both cell lines and~     primary leukemia. Using this approach, we hope to develop novel compounds that are able to be~     used in future leukemic therapy.~   "
185061|NCT01142362|"~     DNA vaccines consist of small pieces of DNA also known as plasmids, and have several~     potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well~     tolerated in humans. The investigators have developed a DNA vaccine, VGX-3400X, which~     includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will~     be delivered via electroporation (EP) which uses the CELLECTRA constant current device to~     deliver a small electric charge following injection, since animal studies have shown that~     this delivery method increases the immune response to vaccine. The vaccine will be given to~     30 healthy adult subjects. It is hypothesized that VGX-3400X + EP will be well tolerated and~     immunogenic.~   "
185062|NCT01142349|"~     This study compares the efficacy of three group interventions for people with co-morbid~     osteoarthritis (OA) and insomnia to help them manage their OA symptoms. The investigators~     hypothesize that a combination cognitive-behavioral treatment will produce significantly~     greater initial and long-term improvements in OA symptoms than will the other two treatments.~   "
185063|NCT01142336|"~     A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it~     produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's~     disease.~   "
185064|NCT01142323|"~     The purpose of this study is to determine whether fenofibrate is safe and effective in the~     treatment primary sclerosing cholangitis (PSC).~   "
185065|NCT01142310|"~     Stress and corticosteroid exposure are associated with changes in both the human and animal~     hippocampus. An extensive literature suggests that corticosteroid-induced changes in the~     hippocampus are, in part, mediated through increases in extracellular glutamate. In animals,~     agents that decrease glutamate release prevent dendritic changes in the hippocampus secondary~     to stress or corticosterone. We have developed a research program using patients receiving~     prescription corticosteroids (e.g., prednisone) to explore the effects of corticosteroids on~     the human hippocampus. Our research program is translational in focus, with a goal of~     exploring whether the reported effects of corticosteroids on the animal hippocampus are also~     found in humans. A current focus of our research is examining glutamate release inhibitors in~     patients taking corticosteroids. We have both open-label and placebo-controlled pilot data~     suggesting that the glutamate release inhibitor lamotrigine is associated with significant~     improvement in declarative memory (a measure of hippocampal performance) in this population.~     A definitive study examining declarative memory in corticosteroid-dependent patients~     receiving lamotrigine vs. placebo is proposed. Neuroimaging and mood will also be assessed.~   "
185066|NCT01142297|"~     This study compares the patterns of dental implant stabilization between a standard and~     chemically modified implant surface in patients with type 2 diabetes. It is hypothesized that~     the chemically modified surface will enhance early healing events (first 4 months following~     placement)in diabetes patients with compromises in rate of implant integration.~   "
185067|NCT01142284|"~     Based upon evidence of efficacy and safety of both cilostazol and probucol administration in~     independent randomized controlled trials in PAD and CAD, the present trial seeks to~     investigate the effect of concomitant administration of cilostazol and probucol on FMD~     compared to each drug individually, as well as to evaluate biomarker measures and safety~     indices in this context.~   "
185068|NCT01142271|"~     The purpose of this trial is to compare the degree of reflux, operative outcomes and quality~     of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy~     for gastric cancer~   "
185069|NCT01142258|"~     The purpose of this study is to determine whether trazodone is effective in the treatment of~     sleep disorders in Alzheimer's disease (AD).~   "
185070|NCT01142245|"~     The investigators previously showed that the use of a high-dose intravenous PPI regimen after~     endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding,~     decreased the need for endoscopic and surgical interventions and in general improved~     patients' outcomes. A trend towards reduced mortality associated with the use of high-dose~     intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence~     that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis~     suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce~     rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to~     oral PPI in this patient population.~      The purpose of this clinical study is to compare the efficacy and safety of intravenous and~     oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent~     bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.~   "
185071|NCT01142232|"~     This is a research study for newly diagnosed multiple myeloma or multiple myeloma has~     returned (relapsed). Multiple myeloma is a type of cancer that begins in white blood cells~     called plasma cells. Plasma cells make proteins that help fight infections. Current therapy~     for multiple myeloma includes high dose chemotherapy and autologous (patient's own cells)~     stem cell transplantation.~      There will be two parts (or phases) to this study:~      The purpose of the first part is to find the highest dose of a drug called lenalidomide~     (Revlimid®) that can be given in combination with high dose melphalan without causing severe~     adverse events.~      The purpose of the second part is to find out the effects of this treatment (good and bad) on~     multiple myeloma patients.~   "
185072|NCT01142219|"~     One of the main problems in sickle cell disease is the decreased bioavailability of nitric~     oxide and arginine. This study was designed to assess if treating sickle cell disease~     patients with L-arginine would improve pulmonary arterial pressure and other aspects.~   "
185073|NCT01142206|"~     The purpose of this investigation is to conduct an 8-week pilot study to examine the effects~     of two different leisure-time activity prescriptions on dietary intake, leisure-time~     activities, and weight loss in 30 adults receiving an 8-week behavioral weight loss~     intervention.~   "
185074|NCT01142193|"~     The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive~     therapy in patients with refractory partial onset-seizures.~   "
185075|NCT01142180|"~     The aim of this study is to determine if early angiographic embolization can forestall~     recurrent bleeding in selected high risk ulcers after their initial endoscopic control; to~     validate prospectively the investigators proposed in selecting high risk ulcers for recurrent~     bleeding in spite of maximal endoscopic control and profound acid suppression using high dose~     intravenous infusion of proton pump inhibitor; to characterize the nature of bleeding~     arteries in severely bleeding peptic ulcers and determine the efficacy of angiographic~     embolization in the prevention of recurrent bleeding and to establish safety profile of~     angiographic embolization as an early elective treatment to bleeding peptic ulcers.~   "
185076|NCT01142167|"~     The aim of the study is to study the caecal intubation rate of a prototype ultra-thin~     colonoscope compared to a standard colonoscope and to study usefulness of this new~     colonoscope as a rescue instrument for failed initial colonoscopy with a standard colonoscope~     and to study the patient satisfaction scores using a validated endoscopy GHAA-9 for a new~     prototype colonoscope as compared to a standard colonoscope.~   "
185077|NCT01142154|"~     This study is to compare the exposure of orally administered Prodarsan to the intravenous~     dosed Osmitrol (10% solution) in Cockayne Syndrome (CS) patients. Also the pharmacokinetics~     of single and multiple orally dosed Prodarsan will be evaluated and compared to intravenous~     dose of Osmitrol in CS patients.~   "
185078|NCT01142141|"~     To evaluate the effectiveness of manual therapy (joint mobilization and massage) combined~     with kinesiotherapy in women with impaired range of motion after axillary lymph node~     dissection due to breast cancer regarding the recovery of shoulder range of motion and~     functionality of the upper limb.~   "
185079|NCT01142128|"~     Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic~     abdominal pain in patients with small duct chronic pancreatitis in a superior fashion~     compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an~     increase in quality of life. Our objective is to elucidate the role of Nexium in the control~     of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16.~     Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased~     ER visits and decreased hospital admissions for abdominal pain.~   "
185080|NCT01142115|"~     The purpose of this study is to evaluate the safety of a new developed catheter in comparison~     with an catheter on the market. The study is randomised.~   "
185081|NCT01142102|"~     The principal objective of the trial is to test the hypothesis that Online Adaptive~     Radiotherapy for Muscle Invasive Bladder Cancer is feasible across multiple Radiation~     Oncology departments.~   "
185082|NCT01142089|"~     The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective~     treatment for Traveler's Diarrhea.~   "
185083|NCT01142076|"~     Xinju Xiaogao prescription and 10% of it in the treatment of adiposity (stagnation of QI~     causing phlegm retention)clinical study~   "
185084|NCT01142063|"~     The purpose of the study is to demonstrate the bioequivalence of the proposed commercial~     neratinib tablet formulation (240 mg strength x 1) to the reference Phase 3 tablet~     formulation (40 mg tablet strength x 6) under fed and fasted conditions in healthy subjects.~   "
185085|NCT01142050|"~     The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin~     Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.~   "
185086|NCT01142037|"~     Certain plant foods are high in furanocoumarins. Test tube and animal studies suggest that~     furanocoumarins may help prevent cancer. It is difficult to determine in humans if~     furanocoumarins do prevent cancer because there isn't an objective way to tell who has eaten~     these compounds. This study will develop a urine test to determine if an individual ate foods~     that contain furanocoumarins.~   "
185087|NCT01142024|"~     With the wide use of contrast agents in clinical diagnosis and treatment, contrast induced~     nephropathy(CIN) accounts for 1/3 of hospital acquired acute renal failure.The mortality rate~     of patients with CIN is up to 35%,and about 30% patients with permanent renal~     dysfunction.Prevention and treatment of this iatrogenic complication and reducing morbidity~     has become an urgent task to every medical worker.~      Now the pathogenesis of CIN is not clear,while the toxicity of renal tubular epithelial cell~     and the hypoxia of renal medullary is likely to be the main mechanism of CIN.Iodine contrast~     agent concentrate in the tubular and collecting duct and directly damage cells,leading to~     tubular cell death;also induce the release of renal vasoconstrictors,such as adenosine,~     endothelin, causing acute vasoconstriction.Furthermore,oxidative stress and the inflammatory~     response induced by ischemia may worsen kidney function.~      Thus a large number of studies focus on oxidative stress in the pathogenesis of~     CIN.Recently,some studies have shown that oxidative stress proteins play an important role in~     acute renal injury(AKI),and have reported that these proteins of different genotypes related~     to the incidence and prognosis of AKI.~      Therefore,the investigators speculate whether some patients have genetic potential of~     increased oxidative stress,and are more prone to contrast induced nephropathy? At~     present,there are a great number of researches about preventive measures of CIN.The firstly~     and widely used therapy is hydration.But it just dilutes iodine contrast medium in renal~     tubular and collecting duct,increases urine output to prevent the formation of tubular~     crystals.According to the pathogenesis of CIN,oxidative stress plays an important role in~     CIN,thereby several antioxidants,such as N-acetyl cysteine or Glutathione are also under~     study.But results are inconsistent.~      As a result,the investigators designed this study to evaluate the oxidative stress in~     cardiovascular population on the impact of contrast medium nephropathy,and the relationship~     in antioxidant enzymes with genetic polymorphisms,to find clinical indicators predicting~     renal dysfunction and guiding individual treatment to prevent its occurrence.~   "
185088|NCT01142011|"~     Hypothesis; That inhibition of plasma Blys by the monoclonal antibody Belimumab will reduce~     both the survival of the lymphoplasmacytoid cells of Waldenstrom Macroglobulinaemia (WM), and~     their production of monoclonal IgM, resulting in a reduction of IgM paraprotein.~   "
185089|NCT01141998|"~     Purpose:~      The overall objective of this study is to learn more about the disease chronic pancreatitis~     and thus contribute to better treatments. The investigators will gain this by studying the~     effects of vitamin D in the body immune system and bones. The investigators will also study~     the uptake of vitamin D through the intestine compared with the amount of vitamin D obtained~     through exposure to UVB rays.~      The investigators have set a series of questions which the investigators want to answer with~     this experiment:~      Do patients with chronic pancreatitis have reduced absorption of vitamin D from the gut?~        -  Have the two treatment methods with vitamin D, UV radiation and tablets, the same~          success rate?~        -  Does the distribution of the white blood cells change when the vitamin D level increases~          and does it depend on whether the patient have UVB radiation or tablet with vitamin D?~        -  Will patients require reduced amounts of painkillers when vitamin D level increases?~        -  Does vitamin D have influence on blood sugar and thus the risk of diabetes or worsening~          of this?~        -  Could vitamin D affect the blood content of inflammation markers?~        -  Does the patient feel better when he takes vitamin D?~        -  Does bone strength increase when the patients receive grants of vitamin D?~   "
185090|NCT01141985|"~     The objective of this study is to evaluate the ease of use of a modified, disposable contact~     lens and suction ring assembly.~   "
185091|NCT01141972|"~     Specific Aim 1: To compare effects of Vitamin D supplementation to usual care on symptoms in~     women transitioning to early postmenopause and determine the associated effect size in order~     to conduct a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in~     early postmenopause who are randomized to supplementation, titrated to achieve sufficiency~     for 2 months, will have fewer symptoms including hot flashes, mood, and musculoskeletal~     complaints than women randomized to usual care.~      Specific Aim 2: To compare effects of Vitamin D supplementation to usual care on body~     composition (by dual-energy x-ray absorptiometry [DXA] and by weight, BMI, waist to hip~     ratio) in overweight/obese women transitioning to early postmenopause and determine the~     associated effect size for a power analysis for a future RCT. Hypothesis: Vitamin D~     insufficient women in the menopausal transition randomized to supplementation, titrated to~     achieve sufficiency for 9 months, will improve DXA body composition (less total body and~     abdominal fat), compared to women in usual care, who will have increased body weight,~     including total and abdominal fat.~      Specific Aim 3: To estimate the proportion of overweight/obese middle-aged women who achieve~     sufficiency by 1 month versus 2 or more months and to determine if achieving sufficiency by 1~     month varies by baseline characteristics. Hypothesis: About 80% of participants will achieve~     sufficient Vitamin D level by 1 month. Those who need more than 1 month for sufficiency will~     have lower baseline levels and higher initial BMI.~   "
185092|NCT01141959|"~     The investigators are interested in identifying patient-specific factors related to donor~     chimerism in patients who receive nonmyeloablative hematopoietic stem cell transplants from~     haploidentical donors. We will look how patients' bodies break down and immediately respond~     to cyclophosphamide, fludarabine and mycophenolate mofetil.~   "
185093|NCT01141946|"~     Lung cancer remains the leading cause of mortality from malignant diseases in both men and~     women worldwide. Accurate diagnosis, staging and therapeutic targeting of lung cancer and~     other pulmonary pathology are vital with regards to providing patients with expedient and~     accurate treatment and treatment plans. The pre-operative evaluation and consultation in~     patients who are to undergo operative staging or resection for lung cancer is~     multidimensional and involves detailed history taking, physical examination and review of~     imaging studies. Two important elements of both staging and pre-operative evaluation include~     the evaluation of: (1) the pleural space for malignant pleural effusion and (2) the diaphragm~     for appropriate movement. At this point in time, the pleural space evaluation is being~     performed using CT scan which does not allow the acquisition of real-time cytological~     material from pleural effusions due to the fact that the CT scans are done in a diagnostic~     setting. Diaphragmatic movement/excursion is not currently being assessed pre-operatively and~     its impact on staging and post-operative pulmonary function is unknown.~      Malignant pleural effusion is recognized as a poor prognosticator in non-small cell lung~     cancer patients and has recently been upgraded from a T4 to an M1a status in the new edition~     of the AJCC NSCLC Staging System (7th Edition). The appreciation of the poor prognosis~     related to malignant effusion has upgraded the stage from a Stage IIIb to a stage IV.~     Recognizing the stage early allows for more precise prognostication of disease and can lead~     to precision and streamlining of treatment plans for thoracic surgeons and oncologists.~   "
185095|NCT01141920|"~     New admissions (n = 120) to the Addiction Treatment Services (ATS) will be stabilized on~     methadone and randomly assigned to one of two induction conditions: 1) routine stepped care,~     or 2) low threshold stepped care. All participants will continue with routine stepped care in~     month 4. Treatment retention is the primary outcome measure, while drug use (measured via~     weekly urinalysis testing) is the major secondary outcome.~   "
185096|NCT01141907|"~     Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic~     proportions. Annual rates of new and recurrent HF events including hospitalization and~     mortality are higher among African Americans. In this study, the investigators are testing an~     interdisciplinary model for heart failure care, with focus on enhancing self management and~     use of telehealth, which has significant potential to improve self management and outcomes.~      The main purpose of this study is to learn how to help African Americans with heart failure~     care for themselves at home. We hope to find out if a team including a nurse and community~     health navigator using a computer telehealth device can help people with heart failure stay~     healthier. The team will help people with heart failure to manage their medication, monitor~     their symptoms and weigh themselves every day after they leave the hospital. The team will~     also help people with heart failure learn to solve problems that may keep them from following~     their treatment plan.~   "
185097|NCT01141894|"~     The investigators aimed to compare the costs and consequences of 'routine perioperative fluid~     therapy' and 'GDHT in terms of morbidity, mortality, length of hospital stay, activity of~     daily living, health related quality of life, cognitive functions and need of social services~     and up till 12 months following operations of proximal femoral fracture at elderly. The~     primary hypothesis is that 'GDHT is a better strategy than 'routine fluid therapy' in terms~     of reduced frequency of postoperative complications.~   "
185098|NCT01141881|"~     Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen~     activator(tPA) in treatment of refractory diabetic macular edema(DME).~   "
185099|NCT01141868|"~     This study examines the efficacy of an Internet-delivered intervention to reduce symptoms of~     insomnia in breast cancer survivors. Breast cancer patients with insomnia (N=30) will be~     assigned to either gain access to the 6-week treatment program immediately (experimental~     group) or following study participation (control group).~   "
185100|NCT01141855|"~     The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the~     opportunity that is provided by admission for acute smoking related illness, to assist~     patients through withdrawal by use of a combination of:~        -  the new medication Champix with~        -  best practice counselling~        -  initiated in an inpatient setting~      to achieve:~        -  sustained smoking abstinence~        -  reduced hospital bed and health service utilisation~        -  reduced inpatient smoking and craving prior to discharge~   "
185101|NCT01141842|"~     Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled~     breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer~     dogs are trained to distinguish between the BS of patients with lung cancer and healthy~     individuals (controls). In a prospective, randomized blinded study the dog's ability to~     differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory~     airway disease, but no evidence of cancer and iii) healthy individuals is tested.~   "
185102|NCT01141829|"~     Obstructive Sleep Apnea (OSA) is associated with increased oxidative stress. The major~     sources of Reactive Oxygen Species (ROS) in the vasculature are the NADPH oxidases. Several~     polymorphisms related to NADPH oxidase expression or NADPH oxidase activity has been~     identified. The investigators are going to compare the distribution of the allelic~     frequencies of A-930G and C242T polymorphisms and their possible relationship with the levels~     of 8-isoprostanes as a marker of oxidative stress in patients with OSA and in a control group~     without OSA.~   "
185103|NCT01141816|"~     Radiofrequency ablation (RFA) is an increasingly popular therapy option for treating small~     kidney cancer, especially for patients who are not ideal candidates for traditional surgery.~     Currently, follow-up after this procedure involves the patient having several CT scans (or~     MRI scans in some cases) over time to monitor for possible cancer recurrence. However, there~     are risks associated with the radiation exposure from CT scans and other risks, such as~     adverse events from the contrast media used in these scans. This study will therefore~     investigate whether a different technique, contrast-enhanced ultrasound (CEUS), can be an~     effective tool for follow-up monitoring of kidney cancer patients who have undergone RFA by~     comparing the results of their standard follow-up CT scans (or MRIs if applicable) with the~     results of CEUS. If CEUS is found to be just as effective as CT scans or MRIs in detecting~     kidney cancer recurrence, this technique could potentially become the new standard of care~     for follow-up.~   "
185104|NCT01141803|"~     The investigators will assess the protective and antiinflammatory effects of processed fruit~     and fruit fibre in overweight subjects with signs of metabolic syndrome. A single-blinded~     parallel study is conducted to investigate the protective effects of fruit fibre on colonic~     epithelium. Relevant signalling pathways related to cholesterol metabolism, vascular~     inflammation, oxidative defence, apoptosis and sterol metabolism will be targeted. Volunteers~     are randomly assigned one of three groups. They are instructed to follow a polyphenol and~     pectin restricted diet for six weeks. The last four weeks in this six week period, the~     restricted diet is supplemented with whole apples (550g/day), apple pomace (22g/day) or~     nothing. Blood, urine, faecal samples and colon biopsies are collected before and after the~     four weeks intervention period.~   "
185105|NCT01141790|"~     Objectives: (1) To check music or voice message influence on vital signs, facial expressions~     or muscular tonus of coma, vegetative or sedated patients; (2) To connect the existence of~     patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale; (3)To~     evaluate the relation between the response and the score of Glasgow Outcome Scale.~   "
185106|NCT01141777|"~     Spirulina, a widely used food supplement, improves the lipid profile and glycemic control in~     people living with diabetes, suggesting that it could have some effects on insulin~     sensitivity. Since HIV-infected patients develop metabolic abnormalities due to the virus~     and/or to antiretroviral (ARV) drugs, the investigators therefore proposed to evaluate the~     effect that spirulina can have on HIV/HAART-associated insulin resistance~   "
185107|NCT01141764|"~     The purpose of this research study is to evaluate the brain circuits function and circuits~     involved in the mechanism of thalamic DBS in patients with medically refractory epilepsy.~   "
185108|NCT01141751|"~     Significant data from placebo-controlled clinical trials have demonstrated the efficacy of~     Rebif in relapsing remitting multiple sclerosis (RRMS) with reduction in relapse rate, delay~     in disability progression, and reduction in magnetic resonance imaging (MRI) activity and~     accumulation of lesion burden. Multiple sclerosis (MS), a chronic neurological diseases, can~     have diverse effects on the lives of subjects and their families. In controlled clinical~     trials, clinical measurement in MS has focused on impairments of neurological assessment~     using Expanded Disability Status Score (EDSS). The assessment of the impact of MS on the~     non-physical aspect of dysfunction is not often measured, or reported. Furthermore,~     traditional clinical measures have not been able to assess the effects of neurological~     illness on quality of life (QoL), which is becoming an increasingly important topic to~     neurologists treating subjects with varied neurological conditions.~      This observational, one arm, multicentric study is aimed to assess the usefulness of the~     Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) instrument in~     comparison with the Multiple Sclerosis Quality of Life-54 instrument (MSQOL-54 questionnaire)~     in RMS subjects on Rebif therapy and to assess the effectiveness of Rebif therapy using~     health related quality of life (HRQoL) measures.~   "
185109|NCT01141738|"~     Intervention studies for stroke caregivers (CG's) during early caregiving are few and have~     met with limited success. The Post-Stroke Rehabilitation Clinical Practice Guidelines (1995)~     recommend sensitivity to the adverse effects of caregiving on family functioning and CG~     health. Breakdown of the informal care system can lead to premature introduction of formal~     services, excess disability, and decline in well-being for stroke survivor and CG alike.~     Thus, it is important to attempt to prevent the chronic distress of stroke CGs through an~     early intervention that prevents and remediates distress, coaches problem-solving and other~     coping skills, can affect multiple outcomes, has durable effects, and is non-threatening and~     accessible. The proposed intervention will incorporate these features and will be low cost~     and feasible for use in clinical practice; it will target outcomes important to stroke CGs,~     depression, anxiety, caregiver preparedness, perceptions of life changes, family functioning,~     and survivor functioning. The individual format will make it possible to address life stage~     needs and cultural issues. Given the prevalence of distress in chronic stroke CGs, early~     intervention to prevent and mediate negative outcomes is essential.~   "
185110|NCT01141725|"~     This phase I/II trial is studying the side effects and best dose of bendamustine~     hydrochloride when given together with idarubicin in treating older patients with previously~     untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Drugs used in~     chemotherapy, such as bendamustine hydrochloride or idarubicin, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells~   "
185111|NCT01141712|"~     This study is a Phase II, multicenter trial assessing overall survival after autologous~     hematopoietic stem cell transplantation using a BEAM transplant regimen (carmustine,~     etoposide, cytarabine, melphalan) in lymphoma patients with HIV.~   "
185112|NCT01141699|"~     There were a breast cancer screening activity in Taipei Medical University-Shuang Ho~     Hospital. We did an intervention with woman who joined the activity.The most important part~     in the intervention was to know health behavior about the breast cancer prevention.By doing~     the study, the investigators will know how to promote the health activity in our community.~   "
185113|NCT01141686|"~     Evaluate chemotherapy related tumor markers on non small cell lung cancer by fluorescent in~     situ hybridization and immunohistochemistry, targets to be studied include EGFR, c-MET,~     topoisomerase II, p53, topoisomerase I, thymidylate synthase, ERCC1, tau, c-myc, RRM1, class~     III tubulin. These targets have been chosen because they are targets for chemotherapeutic~     agents that are currently used in clinical management of these diseases. In total 50 specimen~     will be studied, approximately one third have mutations/deletions of the EGFR gene.To attempt~     to establish a correlation between the pre-selected tumor markers and response to~     chemotherapy, and thus to be able to create a clinically useful classification that would~     provide clinical guidance for selection of the most effective chemotherapy for a individual~     patient, and thus be able to logically design more effective clinical trials for the future.~   "
185114|NCT01141673|"~     FLT3 overexpression in acute myeloid leukemia (AML) is often caused by mutations in this~     gene. These mutations cause constitutive phosphorylation of FLT3 proteins leading to~     increased proliferation and survival, decreased apoptosis and resistance to chemotherapeutic~     agents in AML cells. There are two major types of FLT3 mutations- internal tandem duplication~     (ITD) and point mutation at 835th amino residue. AMLs with FLT3 mutations have worse~     prognosis and are often resistant to conventional chemotherapy. Several small molecule~     compounds targeting FLT3 have been in the market or in clinical trials. Therefore,~     identification of these mutations at the time of diagnosis will provide a better prognostic~     prediction, might guide the treatment selection and follow-up strategies. In this study, the~     investigators will develop a sensitive molecular assay to detect FLT3 mutations for future~     clinical application. The investigators will collect 100 AML samples with at least 20 samples~     with known FLT3 mutations. The investigators will compare this assay with commonly used~     methods and standardize the procedure to meet the requirement of clinical pathology~     laboratory with reasonable cost.~   "
185115|NCT01141660|"~     The aim of the current study is to compare the use of laryngeal mask airway (LMA) and~     endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess~     the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also~     sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We~     hypothesized that the LMA would be a safe efficient alternative to the ETT.~   "
185164|NCT01141010|"~     Pregnancy induced psychosis is an essential factor that influencing maternal health~     postpartum. When gravidas, especially nulliparas, facing labor and delivery, they will~     undoubtedly encounter burden from their own and surrounding facts. Maternal psychosis takes a~     large part of women's psychological disorders. No matter which way, either spontaneous or~     surgical, they would choose, many factors influence their psychological state. Cesarean~     section poses higher risks for women than vaginal delivery. Therefore, how to seek effective~     methods to alleviate parturients' psychological stress response possesses pivotal clinical~     implications. Herein the investigators proposed that different linguistic interventions given~     pre-, intra- or post-operatively would produce different effect on maternal psychology and~     internal stress level.~   "
185116|NCT01141647|"~     This study will be an extension of the Spinal Cord Injury Vocational Integration Program~     (SCI-VIP). The study involves research about how to help Veterans with spinal cord injury~     (SCI) gain employment. Vocational rehabilitation is a special field of service aimed at~     putting persons with disabilities in the best possible position to become employed. The~     Veterans Administration has a long history of providing vocational rehabilitation for~     Veterans with mental health issues and has recently started providing similar services to~     persons with physical disabilities, including SCI. Past research has shown that vocational~     rehabilitation is effective in helping some Veterans with spinal cord injury (SCI) gain~     employment. The extension of this work through PrOMOTE study will establish a large national~     database of over 2000 Veterans with SCI, containing extensive employment, medical, functional~     and psychosocial data. The study will analyze both quantitative and qualitative measures to~     maximize its findings.~   "
185117|NCT01141634|"~     Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents~     during childhood, and is characterized by developmentally inappropriate levels of inattention~     and/or hyperactive-impulsive behavior. It is proposed that classical homeopathic treatment~     can reduce the symptoms of ADHD without serious side effects. This is an open label pilot~     feasibility study (36 participants). Participants, age 6-16, will consult with a homeopathic~     practitioner who will select treatments based on classical homeopathy principles. All~     participants will be assessed on a 4-weekly basis for a total of 36 weeks. The purpose of the~     study is to assess feasibility of recruitment and patient retention, to obtain pilot data on~     which to base a sample size calculation for future study, and to identify major safety~     concerns. The study will use single homeopathic medicines approved for over-the-counter use~     in Canada. The primary outcome measure will be the validated Conners 3rd Edition - Parent.~   "
185118|NCT01141621|"~     The purpose of this study is to~        1. better characterize the short term and long term natural history of hereditary~          spherocytosis (HS) including diagnosis, complications, and indications for and response~          to splenectomy~        2. evaluate and describe the health-related quality of life in children with HS.~   "
185119|NCT01141608|"~     The purpose of this study is to investigate if health interventions (intensive exercise or~     health education) can be used to help improve substance abuse treatment. The primary~     objective of this protocol is to compare percent days of abstinence between Vigorous~     Intensity High Dose exercise (VIHD) and Health Education Intervention (HEI) groups based on~     stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding~     caffeine and nicotine) use during a 12-week acute phase.~   "
185120|NCT01141595|"~     The purpose of this study is to develop biomarkers for central nervous system BH4~     concentration in children with autism so they can be easily screened to determine if they may~     benefit from BH4 supplementation. Kuvan is a synthetic form of BH4. BH4 is an enzyme cofactor~     that is essential for several critical metabolic functions.~   "
185121|NCT01141569|"~     The purpose of this study is to evaluate the activity of RO4929097 in renal cell carcinoma~     patients that have failed therapy with VEGF/VEGFR directed agents.~   "
185122|NCT01141556|"~     Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are~     involved in the inflammatory response regulation. The degree of selenium deficiency~     correlates with disease severity and the incidence of mortality in critically ill patients.~     The aim of our study is to evaluate, if high dosis selenium supplementation (loading dose~     4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced~     organ dysfunction and length of ICU-stay in patients after heart surgery.~   "
185123|NCT01141543|"~     The study will be conducted as a single center Phase I/II study to evaluate the safety of~     administering Plerixafor administered as part of a myeloablative preparative regimen~     (Institutional Protocol:Fludarabine 50mg/m2/da x 4 days, Busulfan 3.2mg/kg/day x 4 days, TBI~     400cGy in divided fractions) for stem cell transplant recipients with AML and to determine~     whether or not residual leukemic stem cells can be mobilized. Three patients will be enrolled~     into each of 4 sequential cohorts. Patients in the first cohort will receive 1 dose of~     Plerixafor (240mcg/kg sc) prior to administration of the first dose of Fludarabine and~     Busulfan. If tolerated it is planned to escalate the number of Plerixafor doses in the~     subsequent cohorts to 2. 3. and 4 to be administered before the respective 2nd, 3rd, and 4th~     dose of chemotherapy.~   "
185124|NCT01141530|"~     This project is a pilot study designed to investigate transcriptional regulation in breast~     cancer. Although the main focus of the present study will be triple negative breast cancer~     where all of the clinically relevant receptors - estrogen receptor (ER), progesterone~     receptor (PR) and herceptin (HER2) - are absent, all breast tissue biospecimens, including~     normal and mammary dysplasia, stored in the UAMS Tissue bank, procured from outside~     collaborators or purchased from commercial vendors will eventually be investigated. We will~     use high throughput molecular profiling techniques such as microarrays and next generation~     sequencing to correlate gene expression and gene expression regulation with clinical~     parameters such as tumor size, time to relapse and overall survival.~   "
185125|NCT01141517|"~     The primary objective of this research is to explore relations between impulsive behavior and~     smoking-cessation success among treatment-seeking teens enrolled in a quit-smoking program.~      It is hypothesized that teens who do not successfully stop smoking (or who drop out of the~     treatment program) will be more impulsive (from measures taken just prior to treatment) than~     those who do successfully stop or significantly reduce rate of smoking.~   "
185126|NCT01141504|"~     Adenosine-triphosphate (ATP) serves as the sole energy source for muscle contraction.~     Therefore human performance of brief maximal exercise is limited, in part, by the~     availability of ATP to the contracting muscle. Because muscle ATP storage is small (enough to~     sustain maximal exercise for less than 1 second), factors that enhance either storage or~     resynthesis of ATP may have a positive impact on repeated muscle contractions. The current~     study will test the hypothesis that increasing ATP availability to muscle via oral~     supplementation will improve performance of repeated high intensity exercise as measured by~     a) work performed in each of the three 50 contraction fatigue tests, b) sum of total work~     performed, and c) percentage decrement in total work from the first to third third 50~     contraction test.~   "
185466|NCT01137006|"~     A dose escalation study designed to determine the safety, maximum tolerated dose,~     anti-melanoma activity, antibody blood levels and progression-free survival in patients with~     malignant melanoma receiving IMC-20D7S either every two weeks or every three weeks.~   "
185127|NCT01141491|"~     Sarcoma patients are at high risk for their cancer to recur even when the sarcoma has been~     removed surgically or treated with radiation or chemotherapy. The patients in the study will~     be randomized (like flipping a coin) to receive either a vaccine that is combined with an~     immune system stimulant or the immune system stimulant alone. The immune system stimulant is~     called OPT-821 and is an immunological booster. The trivalent vaccine is being developed to~     teach the patient's immune system to recognize 3 types of sugars called GM2, GD2 and GD3 that~     are found primarily on the surface of sarcoma cells. If the trivalent vaccine can stimulate~     the patient's immune system to develop antibodies which recognize and target the GM2, GD2 and~     GM3 sugars, then the patient's antibodies could attack and kill any remaining sarcoma cells~     potentially preventing the recurrence of sarcoma.~   "
185128|NCT01141478|"~     This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared~     to Sorafenib alone will produce the best results for treating patients with Hepatocellular~     Carcinoma.~   "
185129|NCT01141465|"~     This study will evaluate and compare the effectiveness of asthma management in patients with~     evidence of persistent asthma following a switch in asthma therapy to combination inhaled~     glucocorticosteroid (ICS) / long-acting bronchodilator (LABA) therapy as either:~     fixed-combination fluticasone propionate / salmeterol (FP/SAL; Seretide®) via pressurised~     metered-dose inhaler (pMDI) or dry-powder inhaler (DPI) plus as-needed (prn) reliever therapy~     (salbutamol as DPI, BAI or pMDI), or fixed-combination budesonide / formoterol (BUD/FOR;~     Symbicort®) via DPI plus prn reliever therapy (salbutamol as DPI, BAI or pMDI or bricanyl as~     DPI). The final analysis plan will define exact comparators and age groups to be studied~     after reviewing baseline data.~   "
185130|NCT01141452|"~     The objective of this study is to compare the effectiveness, cost-effectiveness and direct~     healthcare costs of managing chronic obstructive pulmonary disease (COPD) in primary care~     patients with evidence of COPD who either initiate inhaled corticosteroid (ICS) therapy, or~     have an increase in their ICS dose, as hydrofluoroalkane (HFA) beclometasone dipropionate~     (BDP) (hereafter Qvar®), CFC-BDP (hereafter BDP) and fluticasone propionate (FP) via~     pressurised metered-dose inhalers.~   "
185131|NCT01141439|"~     The objective of the study was to compare the effectiveness, cost-effectiveness and direct~     healthcare costs of managing asthma in patients with evidence of persistent asthma, following~     the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP~     (Qvar®) (either as initial therapy or as a step-up therapy) compared with the most commonly~     prescribed alternative ICS in the UK, CFC-beclometasone (BDP) and fluticasone (FP) as metered~     dose inhalers (MDIs). Qvar vs FP analyses were split between adults (12-60yrs) and~     paediatrics (5-11yrs).~   "
185132|NCT01141426|"~     This study will use a randomized parallel group design to examine the effects of Intensive~     Short-term Dynamic Psychotherapy (ISTDP) for depressed patients non-remitting following at~     least one course of antidepressants. The effects of ISTDP will be judged through comparison~     against secondary care treatment as usual. The aim is to establish the clinical and cost~     effectiveness of ISTDP treatment.~   "
185133|NCT01141413|"~     The purpose of this study is to describe infliximab and abatacept dosing patterns (i.e.,~     dosing amount and frequency) and costs among a population of managed care enrollees with RA.~     This study will also identify changes in infliximab and abatacept dosing over time and the~     implication these changes may have on the costs of medication administration.~   "
185134|NCT01141400|"~     The primary objective of this study is to measure the effects of patient cost-sharing on the~     initiation of adjunctive treatment and subsequent healthcare utilization and expenditures~     among a population of commercially insured adults on antidepressant therapy.~   "
185135|NCT01141387|"~     The primary objective for this study is to assess the impact of a measurement based treatment~     program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary~     care provider (PCP) receives monthly patient-reported depression severity reports compared to~     patients whose PCP does not receive monthly reports.~   "
185136|NCT01141374|"~     Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and~     review the auriculotherapy effectiveness through semi-permanent needles and seeds.~   "
185137|NCT01141361|"~     The purpose of this study is to assess the feasibility of home-based measurement of walking~     capacity in peripheral arterial disease (PAD) patients, uing the Global Positioning System~     (GPS). This study should state if the GPS technique could be used in clinical routine in~     order to assess walking capacity in PAD patients. Patients will be assessed a first time~     (test 1) and six months later (test 2).~   "
185138|NCT01141348|"~     The overall goal of the translational research is to evaluate the processes and outcomes of~     implementing, in a range of public health agencies, an intense, evidence-based behavioral~     weight loss intervention with demonstrated effectiveness among midlife low-income women. The~     intervention was originally studied in a single coordinated community health care~     center/church setting and delivered by research staff. The investigators will evaluate the~     intervention's translation and test its effectiveness as implemented by existing staff in six~     public health agencies supported by local community resources.~   "
185139|NCT01141335|"~     To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE~     Mesh, and to compare it with the traditional Lichtenstein procedure performed with~     polypropylene mesh.~   "
185140|NCT01141322|"~     Cholestatic drug-induced liver injury (DILI) is the severe form of DILI with a grave outcome.~     Drug-metabolizing enzymes play an important role in the metabolism of drugs. The genetic~     polymorphism of drug-metabolizing enzymes may influence the activities and expression of~     these enzymes and thereby affect the susceptibility and severity of DILI.~     UDP-glucuronosyltransferase (UGT) is an important phase 2 detoxification enzyme, which is~     related to congenital hyperbilirubinemia. Recently, the genetic polymorphism of UGT1A1 was~     reported to be associated with jaundice induced by some drugs, and UGT1A7 was shown to be~     related to the susceptibility of hepatocellular carcinoma and other cancers. Ursodeoxycholic~     acid (UDCA ) is a hydrophilic bile acid that is increasingly used for the treatment of~     various cholestatic disorders. The aims of this study are (1) to assess the association of~     the genetic polymorphism of UGT1A1 and 1A7, and the susceptibility and severity of~     drug-induced liver injury (DILI), with emphasis on the cholestatic DILI; (2) to evaluate the~     treatment effect of UDCA in the DILI, with special reference to the cholestatic~     hepatotoxicity.~   "
185141|NCT01141309|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     sorafenib and everolimus will have on your thyroid cancer. Treatment guidelines from the~     National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid~     cancer. Sorafenib is pill that is approved by the FDA for the treatment of kidney and liver~     cancers. Sorafenib may work in many different ways. It helps decrease the blood supply to~     tumors. By doing so, it may limit the tumor's source of oxygen and nutrients and prevent the~     tumor from growing. Everolimus is an oral medication that is FDA approved for the treatment~     of kidney cancer. It inhibits a protein kinase called mTOR (mammalian Target of Rapamycin).~     In laboratory studies, the addition of everolimus to sorafenib works better than sorafenib~     alone. These two drugs are being used together to treat other types of cancer in other~     clinical studies. In addition, the cancer will be evaluated to help us find factors that can~     help predict who would benefit most from this combination of drugs.~   "
185142|NCT01141296|"~     The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA)~     and fenofibrate is more effective than UDCA alone in the treatment of primary biliary~     cirrhosis.~   "
185143|NCT01141283|"~     The purpose of the extension phase is to evaluate the long-term safety and tolerability of~     buprenorphine transdermal system (BTDS).~   "
185144|NCT01141270|"~     Comparative pharmacokinetics study after single subcutaneous application of AFOLIA and the~     reference product (Gonal-f®).~      Objective: To demonstrate equivalence within the 80%-125% margin of the reference product for~     the area under the curve (AUC) of AFOLIA compared to (Gonal-f®).~   "
185145|NCT01141257|"~     The purpose of this study is to determine if Angiocal® (PRS-050-PEG40) is safe and well~     tolerated when it is injected into the veins of patients with solid tumors. Other purposes of~     this study are to investigate how the body of the patients reacts to Angiocal®, how the blood~     level of Angiocal® develops after injection and how the tumor responds to the injection of~     Angiocal®.~   "
185146|NCT01141244|"~     This phase I trial studies the side effects and the best dose of temsirolimus when given~     together with irinotecan hydrochloride and temozolomide in treating younger patients with~     recurrent or refractory solid tumors. Temsirolimus may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus~     with combination chemotherapy may kill more tumor cells.~   "
185147|NCT01141231|"~     RATIONALE: Acupuncture may help relieve dry mouth caused by radiation therapy.~      PURPOSE: This randomized phase III trial is studying to see how well one set of acupuncture~     points work in comparison to a different set of acupuncture points or standard therapy in~     treating dry mouth caused by radiation therapy in patients with head and neck cancer.~   "
185148|NCT01141218|"~     RATIONALE: Gathering health information about patients with non-small cell lung cancer who~     never smoked cigarettes may help doctors learn more about the disease. Collecting and storing~     samples of blood from patients with cancer to study in the laboratory may help doctors learn~     more about cancer and identify biomarkers related to cancer.~      PURPOSE: This research study is studying internet-based clinical information and blood sample~     collection from patients with non-small cell lung cancer who never smoked cigarettes.~   "
185149|NCT01141205|"~     Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular~     immunity against HIV-1.~      Target group: Untreated healthy individuals with chronic HIV-1 infection.~      Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine.~      The secondary purpose is to evaluate the clinical effect of the vaccination treatment as~     measured by induction of immunity, lowering of viral load, induction of escape mutations in~     the virus and improvement in the patient CD4 lymphocyte blood counts.~      The third purpose is to evaluate the feasibility of conducting a therapeutic HIV immunization~     study in a poorly-resourced African setting.~      Design: The experiment is designed as a blinded, placebo-controlled phase 1 clinical trial in~     HIV-1 infected individuals in West Africa.~      Numbers of individuals: Phase I: 20 fully evaluable HIV-1-infected patients should enter the~     study (15 vaccine treated and 5 placebo(saline) treated controls).~   "
185150|NCT01141192|"~     Type 2 diabetes is more common among African Americans than Caucasians. African Americans are~     also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The~     investigators don't yet know if there is a connection between not having enough vitamin D and~     type 2 diabetes in African Americans. Researchers have found that the less vitamin D~     Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if~     this is the case for African Americans. The investigators want to better understand how~     vitamin D status and diabetes risk are linked in African Americans. Also, the investigators~     want to see if supplementation with vitamin D will improve your blood pressure, blood sugar,~     & insulin. All of these are in some way related to diabetes. The investigators want to~     measure changes in blood sugar & blood pressure in people who do not have diabetes with the~     hope of learning new information to help treat those that do have diabetes.~      The investigators hypothesize that vitamin D status is related to diabetes risk measured by~     hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in~     non-diabetic African American adults and that body weight status may affect vitamin D status~     in response to vitamin D supplements compared to placebo.~   "
185151|NCT01141179|"~     The study will investigate the impact of reduced renal function on the pharmacokinetic and~     pharmacodynamic profile of LEO 27847. Volunteers with different degrees of renal impairment~     will be administered one dose of the investigational drug and then followed until~     investigational drug is eliminated from the body.~   "
185152|NCT01141166|"~     Objective: To determine the effectiveness of an individual multifactorial intervention on~     falls and undernutrition risk in very older people in the community.~   "
185153|NCT01141153|"~     Objective:~      The main objective is to evaluate the pattern of dual antiplatelet therapy (aspirin, 300 mg /~     day + clopidogrel 75 mg / day) compared to the use of the triple regimen (Acenocoumarol as~     control + acetylsalicylic acid 100 mg / day + Clopidogrel 75 mg / day) in patients with~     atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2) who are undergoing PCI-S.~      Design:~      Randomized, parallel, with two arms, blind evaluation by third parties.~      Patients:~      304 patients undergoing PCI-S with atrial fibrillation, low-moderate risk of stroke (CHADS ≤~     2), which requires prevention of thrombosis~   "
185154|NCT01141140|"~     In the face of an increased prevalence of obesity and chronic diseases in Canada, much effort~     has been invested to educate the population about healthy eating. Although Canadians are now~     aware of the importance of healthier food habits, rates of obesity and chronic diseases are~     still increasing. In addition, even if different labelling strategies are used to identify~     healthier foods in the market, consumers remain confused about what healthy eating should be.~     Might describing foods as healthy have unintended side-effects on food intake? Previous~     literature has shown that perceptions about the healthiness of foods may bias estimations of~     caloric content of foods, leading consumers to underestimate the caloric content of healthy~     food choices. Indeed, the investigators have recently shown that perceiving a food as healthy~     increased intake of that food by 35% in undergraduate female students. The general objective~     of the proposed research is to investigate whether food perceptions influence intake and~     appetite sensations in normal-weight and overweight/obese restrained and unrestrained males~     and females. This laboratory study, in which perceived healthiness and fatteningness of~     oatmeal-raisin cookies will be manipulated during an ad libitum single-meal occasion, will~     increase the investigators knowledge of the effects of external cues (and other psychological~     and physiological factors) on the control of food intake. Because the popularity and demand~     for nutrition information is increasing, such information is needed to improve clinical~     practices aiming at promoting sustainable healthy eating habits to help individuals achieve~     and maintain a healthy weight.~   "
185155|NCT01141127|"~     The purpose of this study is to determine tranexamic acid plasma levels in children~     undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.~   "
185156|NCT01141114|"~     This study will investigate whether patient navigation can increase rates of colorectal~     cancer screening among linguistically and culturally diverse disadvantaged patients served by~     urban community health centers.~   "
185157|NCT01141101|"~     The prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) colonization and~     infections have been increasing in the general population, including the pediatric~     population. It has been reported that MRSA colonization persists for up to four years, and~     therefore the youngest pediatric patients, specifically those who are less than 2 years of~     age, have a high risk of prolonged colonization during a period of time when they are~     susceptible to significant skin and soft tissue infections (SSTIs) attributable to MRSA. Once~     prolonged colonization takes place, recurrent SSTIs are commonplace, resulting in substantial~     morbidity and in some cases mortality, as well as a significant cost to the healthcare~     system. Individuals colonized with MRSA have an increased risk of developing MRSA infections,~     which range from mild disease, such as carbuncles, to severe infections, such as necrotizing~     pneumonia and toxic shock syndrome. The prevalence of severe MRSA infections is also greatest~     in neonates and infants, where increased MRSA colonization has been observed. In the early~     infant period, the most common manifestation of MRSA disease is pustular skin lesions, which~     affect approximately 5% of the general population, with MRSA-colonization being a major risk~     factor for this disease. Moreover, the prevalence of pustular disease is increasing in the~     general population, and there are numerous case reports of invasive, life-threatening MRSA~     disease in the early infant period.~      Corresponding to the increasing prevalence in the community, the carriage of MRSA in pregnant~     women has also escalated, and vaginal carriage is significant in pregnant women. As an~     analogy, maternal vaginal Group B Streptococcal (GBS) colonization is the major risk for~     infant colonization regardless of whether early or late neonatal colonization or disease~     occurs. It is quite feasible that vaginal MRSA carriage predisposes newborns to colonization~     during the birthing process; however, this mechanism has not yet been well studied. There are~     other mechanisms implicated for early infant colonization, including close contact with~     MRSA-colonized mothers through daily care and breastfeeding. MRSA colonization in one~     household member greatly predisposes colonization in others; therefore, early infant~     colonization could result from contact with other MRSA-colonized individuals in a household.~     Currently, it is not clear which factors are the most important in influencing early infant~     MRSA colonization and subsequent infection.~      Not only is the prevalence of MRSA colonization and infection on the rise, but there have~     been few if any measures that have been established to prevent colonization and subsequent~     infection in adults and children. Eradication measures have shown limited long-term benefit.~     If vertical transmission of MRSA can be established as a critical event in the pathogenesis~     of disease, potentially effective strategies could be tested, and possibly the spread of MRSA~     in the community interrupted.~      Hypotheses and Specific Aims:~        1. Identify the proportion, rate and time of MRSA colonization in infants born to mothers~          with and without MRSA colonization;~        2. Compare risk factors for infant MRSA colonization in these two groups;~        3. Determine the prevalence and risk factors for developing MRSA infections in the~          MRSA-colonized infant.~   "
185158|NCT01141088|"~     The overall median survival of nonresectable malignant hilar obstruction in most series has~     been less than 6 months. Most patients with malignant hilar obstruction present with advanced~     disease, making allative endoscopic drainage the principal therapeutic option. However, the~     optimal endoscopic management strategy is contentious. In malignant hilar obstruction,~     exclusively endoscopic placement of bilateral metal stents has been considered very difficult~     and complex, and it may require multiple procedures, with an increased risk of complications~     and mortality. To overcome this difficulty and strategize plan of management, the~     investigators evaluated the technical and clinical efficacy of endoscopic bilateral placement~     of newly designed stents, Y-configuration, followed by side-by-side insertion in failure of~     stent-in-stent method for the management of malignant hilar obstruction.~   "
185159|NCT01141075|"~     Methylmalonic acidemia is a rare genetic disorder caused by mutations in the gene for~     mitochondrial enzyme methylmalonyl-CoA mutase (MCM) or in one of the genes for~     adenosylcobalamin (AdoCbl). Lack of these proteins causes toxic elevations of methylmalonic~     acid (MMacid) in blood, urine, and other tissues. A specific type of mutation, called a~     nonsense (premature stop codon) mutation, is the cause of the disease in approximately 5 to~     20% of patients with mutations in the MCM gene, and approximately 20 to >50% of patients with~     mutations in one of the AdoCbl genes. Ataluren (PTC124) is an orally delivered,~     investigational drug that acts to overcome the effects of the premature stop codon,~     potentially enabling the production of functional MCM/AdoCbl. This study is a Phase 2a trial~     evaluating the safety and activity of ataluren in patients with methylmalonic acidemia due to~     a nonsense mutation. The main purpose of this study is to understand whether ataluren can~     safely decrease MMacid levels.~   "
185160|NCT01141062|"~     This study is to collect supplementary safety and technical effectiveness data of Philips MRI~     guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with~     symptomatic fibroids in a 3T MRI scanner. The importance of this therapy is that it offers a~     non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and~     peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat~     and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and~     monitors heat rise in the fibroid tissue. The goal of the study is to collect supplementary~     3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided~     HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of~     life, and imaging endpoints will be evaluated in all study patients.~   "
185161|NCT01141049|"~     Primary Hypotheses:~        1. Gabapentin will significantly reduce the symptoms of alcohol withdrawal as compared to~          placebo. The primary outcome measure of alcohol withdrawal will be the Clinical~          Institute Withdrawal Alcohol (CIWA-Ar) (Sullivan, Sykora, Schneiderman, Naranjo, &~          Sellers, 1989) score.~        2. Gabapentin will significantly reduce alcohol consumption and promote abstinence as~          compared to placebo. The primary outcome measure will be the number of the heavy~          drinking days (defined as any day where the number of standard drinks was at least 5 for~          men and at least 4 for women) per week as measured by the timeline follow-back method.~      Secondary Hypotheses:~      1. Gabapentin will be superior to placebo in reducing alcohol use as measured by secondary~     outcomes such as amount of drinks per day, amount of drinks per drinking day, percent days~     abstinent and serial measurement of gamma-glutamyl transferase (GGT) serum level.~   "
185162|NCT01141036|"~     Upper GI endoscopy is often performed in patients with chronic liver disease to screen for~     esophageal and gastric varices. The purpose of this study is to compare propofol to midazolam~     for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy.~   "
185163|NCT01141023|"~     This is a observational, multi-center study to assess progression of clinical features,~     imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy~     controls (HC) and in PD patient subtypes.~      The primary objective of this study is to identify clinical, imaging and biologic markers of~     PD progression for use in clinical trials of disease-modifying therapies.~   "
185209|NCT01140412|"~     This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of~     14 healthy male and/or female subjects, to estimate the effect of maraviroc on the~     pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the~     pharmacokinetics of maraviroc.~   "
185165|NCT01140997|"~     This study is a multi-center, randomized, open-label and positive controlled Phase II~     Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin),~     once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients,~     with Pegasys 180mcg/week & Ribavirin as positive control. It is aimed to establish a dose~     response and safety relationship sufficient to allow the subsequent design and conduct of~     Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory~     requirements.~   "
185166|NCT01140984|"~     Post allogeneic hematopoietic stem cell transplantation (HSCT) patients with steroid~     resistant acute GVHD localised to the liver will receive 24 hours continuous intra-arterial~     infusion of methylprednisolone.~   "
185167|NCT01140971|"~     PURPOSE: The purpose of this study is to determine the effectiveness of balloon dilatation~     (Foley) with vaginal misoprostol for cervical ripening and induction of labor.~      METHOD: a randomized clinical assay has been performed with 160 women with indication of~     induction of labor, randomly divided in two groups, 80 for Foley catheter and 80 for~     misoprostol.~   "
185168|NCT01140958|"~     Lung cancer is the No. cause of cancer death in Taiwan. Yet most of lung cancer are diagnosed~     at late stage, not amenable to surgical resection. With the introduction of new targeted~     agents, such as EGFR tyrosine kinase inhibitors and the identification of EGFR mutations,~     lung cancer management has markedly changed in recent years. However, these new agents are~     costly and their payment is restricted in certain situations defined National Insurance~     Agency. Therefore, using databases from National Insurance Agency might not be able to~     reflect the exact impact on pharmacoeconomics. In this study, the investigators will analyze~     the data from a tertiary medical center, where all the costs including insurance~     reimbursement, co-payment, and payment not covered by insurance. The investigators will also~     compare with the investigators results with national database to analyze the cost benefit of~     these new agents on lung cancer.~   "
185169|NCT01140945|"~     The aim of the present study is to examine the association between fertility parameters and~     the periodontal status of men attending fertility and in vitro fertilization clinic.~   "
185170|NCT01140932|"~     The purpose is to investigate the electroretinogram (ERG) in young, healthy men in the~     normoglycaemic and hyperglycaemic state before and after intervention with corticosteroids~     treatment, high calorie diet and exercise restraint.~   "
185171|NCT01140906|"~     The purpose of the study is to evaluate the efficacy, tolerability and the safety of two~     fixed doses of vortioxetine in the treatment of major depressive disorder.~   "
185172|NCT01140893|"~     The purpose of this study is to determine whether exenatide is effective to improve glycemic~     control among type 2 diabetic patients treated by insulin pump therapy.~   "
185173|NCT01140880|"~     This study seeks to evaluate the efficacy of a contingency management (CM) intervention~     compared to a yoked control condition for eliminating illicit stimulant use and for~     decreasing time to initiating post exposure prophylaxis (PEP), for improving adherence to~     PEP, and for completing PEP following a potential HIV-exposure event. Men who have sex with~     men who use cocaine amphetamine or methamphetamine frequently also have high risk sexual~     behaviors during or after their drug use. The objective of this study evaluates whether the~     use of CM that targets stimulant use significantly aids men who have sex with men who use~     stimulants and also engage in high-risk sexual transmission behaviors to be able to initiate,~     adhere to and complete PEP, thereby optimizing the utility of a biomedical HIV prevention~     intervention for reducing HIV incidence in this very high-risk group of MSM.~   "
185174|NCT01140867|"~     The object of this study is to assess the efficacy and safety of zonisamide as adjunctive~     therapy in patients with uncontrolled partial epilepsy.~   "
185175|NCT01140854|"~     While hypotension during general anesthesia has routinely been considered to be a tolerable~     abnormality with little clinical consequence, the proposed study takes the innovative~     approach of defining hypotensive events within the construct of a patient's own hypertensive~     status, fractional mean arterial blood pressure (fMAP). Because the investigators primary~     variable is within the control of anesthesia personnel, the study portends a potentially~     simple and easy to implement treatment. The introduction of neuropsychometric measures as the~     relevant evaluator of post-operative cognitive dysfunction is innovative, and may be more~     relevant to the average elderly patient than simple mortality.~   "
185176|NCT01140841|"~     The purpose of this clinical trial is to determine the maximum tolerated dose of Fipamezole~     in adult patients with Parkinson's disease who are receiving levodopa.~   "
185177|NCT01140828|"~     The aim of this study is to determine whether rabeprazole is superior to placebo in~     preventing dyspepsia and gastroduodenal injury in subjects with osteoarthritis (OA) and/or~     rheumatoid arthritis (RA) and/or bone pain.~   "
185178|NCT01140815|"~     The objectives of this study are to assess the safety and effectiveness of the Journey Deuce~     Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to~     total knee replacement using the Genesis II Total Knee System. The hypothesis is that the~     Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total~     Knee System at the 2-year. The null hypothesis is that there is no difference between the~     groups.~   "
185179|NCT01140802|"~     The aim of this study is to compare the gut microbiota in Chinese patients with Inflammatory~     Bowel Disease (IBD) in Hong Kong with that of healthy controls, compare the gut microbiota in~     IBD patients in a developing country (low but increasing IBD incidence, Hong Kong) with those~     in a developed country (high incidence, Australia), compare the gut microbiota in Chinese~     patients with IBD in Hong Kong with the microbiota of their non-IBD affected parents and~     siblings.~   "
185180|NCT01140789|"~     The aim of this study is to identify new genes in Chinese patients that help investigators to~     understand the biological pathway and functions in a population in whom the incidence of~     Inflammatory Bowel Disease (IBD) is increasing. And to explore the genetic variations in~     Chinese patients with IBD.~   "
185181|NCT01140776|"~     The study will determine the sensitivity, specificity, negative predictive value and positive~     predictive value of the OSNA Breast Cancer System for patients receiving Sentinel Lymph Node~     biopsies after receiving neoadjuvant hormonal/chemotherapy as compared to permanent section~     Hematoxylin and Eosin (H&E) and Immuno-histochemistry (IHC) staining.~   "
185182|NCT01140763|"~     This is a study to evaluate the incidence of sampling bias during pathologic assessment of~     sentinel lymph nodes (SLN) when they are cut at a certain thickness (1 mm) and the tissue~     slices are completely analyzed by histopathology (at 200 µm sections). The sponsor and~     investigators would like to determine how often small cancer deposits are present in one~     slice but not the other. The data will provide an empirical estimate of the incidence of~     tissue sampling bias inherent in using different tissue sections for analysis. The data will~     also show how varying degrees of detail in evaluating the sentinel lymph nodes (SLN) with~     histopathology methods will impact the degree of agreement.~   "
185183|NCT01140750|"~     The purpose of this study is to evaluate if the variability of biological signals, such as~     heart rate and temperature, can predict weaning from mechanical ventilation in patients with~     failure to wean.~   "
185184|NCT01140737|"~     The study objective is to evaluate the therapeutic activity, safety and tolerability of~     axitinib in patients with advanced/metastatic soft tissue sarcoma who are unsuitable for or~     have relapsed after standard chemotherapy. The therapeutic activity will be separately~     assessed in angiosarcoma, synovial sarcoma, leiomyosarcomas and other sarcomas.~   "
185185|NCT01140724|"~     In the United States alone, each year approximately 5 million children undergo painful~     surgery, many of them experience serious side-effects with opioids and inadequate pain~     relief. Safe and effective analgesia is an important unmet critical medical need in children~     and its continued existence is an important perioperative safety and economic problem.~     Inadequate pain relief and serious side effects from perioperative opioids occur frequently~     in up to 50% of children. Morphine, the most commonly used perioperative opioid, has a narrow~     therapeutic index and large inter-patient variations in analgesic response and serious side~     effects. Frequent inter-individual variations in responses to morphine have significant~     clinical and economic impact with inadequate pain relief at one end of the spectrum of~     responses and serious adverse effects such as respiratory depression at the other end. Much~     of the inter-individual variability in response to a dose of morphine following surgical~     procedures can be explained by single nucleotide polymorphisms (SNPs) in a subset of the~     genes that encode proteins involved in pain mechanisms and opioid pathway.~   "
185186|NCT01140711|"~     Aim of study:~      To evaluate changes in feeding-related neural activity after different bariatric procedures~     in morbidly obese patients. Relationship of gut hormone levels will be assessed as well.~   "
185187|NCT01140698|"~     Up-to-date, the preterm newborn nutrition is based on human breast milk or it's imitations.~     However, the growth rate is known to be reduced compared to the fetal growth rate. In order~     to attempt a better growth rate of the preterm newborn infants it is important to evaluate~     the metabolic components of the fetal blood and try to find components that might influence~     its growth.~      Little is known of the metabolic components of the fetal blood, including amino acid profile.~     The aim of the study is to evaluate amino acid profile in the fetus blood in different~     gestational ages and compare it to post natal period.~   "
185188|NCT01140685|"~     This work will focus on the anti-inflammatory and antioxidant pathways in lung diseases by~     measuring HO-1 in induced sputum and CO in exhaled air in cases of four respiratory diseases,~     asthma, chronic obstructive pulmonary disease (COPD), occupational lung diseases (OLD) and~     interstitial lung disease (ILD).~   "
185189|NCT01140672|"~     The goals of this study are to evaluate the safety and tolerability of multiple ascending~     doses of PF-04634817 administered orally to healthy adult subjects. In additional, the plasma~     and urinary pharmacokinetics of multiple ascending doses of PF-04634817 administered orally~     to healthy adult subjects will be evaluated. Finally, the effect of multiple doses of~     PF-04634817 on circulating monocytes will be explored.~   "
185190|NCT01140659|"~     Compare the results obtained with video-assisted sympathectomy performed in two distinct~     levels ganglionic (third versus fourth thoracic ganglion) for the treatment of palmar~     hyperhidrosis, through a blind randomized clinical trial using an objective method to measure~     the sweat before and after the operation.~   "
185191|NCT01140646|"~     RATIONALE: S-adenosyl-L-methionine may help relieve hot flashes in women based upon its~     ability to potentially modulate serotonin.~      PURPOSE: This phase II trial is studying the side effects and how well~     s-adenosyl-L-methionine works in treating hot flashes in women with a history of breast~     cancer or those who do not wish to take estrogen due to a perceived increased risk of breast~     cancer.~   "
185192|NCT01140633|"~     Current measures of adherence detect problems weeks to months after they occur. Because the~     HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral~     therapy, treatment failure may develop before an intervention can be deployed. Real-time~     objective adherence monitoring could redirect efforts from a reactive response to the~     proactive prevention of treatment failure. Because adherence is so closely associated with~     viral suppression, accurate adherence monitoring could also strategically limit viral~     monitoring only to those patients at a defined risk for viral rebound.~      This observational study is assessing a wireless adherence monitoring device and mobile~     phone-based adherence data collection among caregivers of children under the age of ten years~     in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility~     and acceptability of these measures, as well as circumstances of adherence lapses and other~     individual and cultural factors affecting adherence. The qualitative data will be used to~     explore models of adherence behavior, which will likely include the child-caregiver dynamic,~     the child's mental and physical health, and social support mechanism.~   "
185193|NCT01140620|"~     The primary objective of this study is:~      • To determine the effects of ketamine, which blocks the ion-channel gated by the NMDA~     receptor, on performance of cognitive tasks and the extent to which these effects can be~     reversed by the dopamine receptor antagonist, risperidone.~      The secondary objectives of this study are:~        -  To establish whether patients with schizophrenia are able to reliably complete the~          biomarker test battery and to assess whether their responses are similar to healthy~          volunteers treated with ketamine.~        -  To establish a multi-site recruitment and assessment capacity based on shared Standard~          Operating Procedures across three study centres.~   "
185242|NCT01139983|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research study is studying DNA biomarkers in samples from patients with~     osteosarcoma and healthy volunteers.~   "
185194|NCT01140607|"~     Primary Objectives:~        -  To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when~          administered to advanced solid tumor patients with varying degrees of hepatic impairment~        -  To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees~          of hepatic impairment~        -  To correlate PK variables with pharmacodynamic (PD) safety parameters in order to guide~          prescribers with regard to dosing in this patient population~        -  To assess the effect of cabazitaxel at recommended dose of 25mg/m^2 on CYP3A enzyme~          activity using midazolam as probe in an additional cohort of cancer patients with normal~          hepatic function.~   "
185195|NCT01140594|"~     A prospective comparison of eyes undergoing wavefront-guided LASIK in one eye and~     wavefront-guided PRK in their fellow eye for myopia.~   "
185196|NCT01140581|"~     Primary Objective:~      - Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization~     according to different timings of initiation of dronedarone.~      Secondary Objective:~        -  Evaluate the rate of AF recurrences two months after randomization.~        -  Assess the safety of the change from amiodarone to dronedarone~        -  Assess dronedarone safety~        -  Explore dronedarone and its active metabolite plasma level (in a subset of countries)~        -  Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone~          (in a subset of countries)~   "
185197|NCT01140568|"~     The purpose of this study is to determine the survival, disease response, and side effects of~     Tasigna® (nilotinib) in patients who have malignant gliomas and are positive for Platelet~     Derived Growth Factor Receptor (PDGFR) amplification. This study is designed to test the~     hypothesis that patients with malignant gliomas with PDGFR amplification are sensitive to~     PDGFR kinase inhibitors.~   "
185198|NCT01140555|"~     This pilot study has a sequential design involving three groups to ensure appropriate~     development and evaluation of the optimal procedural steps of the D-UAO device and to confirm~     that those steps are reproducible in the hands of multiple surgeons.~   "
185199|NCT01140542|"~     This study is a proof of concept study to confirm in a standardized manner the therapeutic~     efficacy of roflumilast in type 2 diabetes mellitus patients.~   "
185200|NCT01140529|"~     Primary hypothesis: Dexmedetomidine is equal or superior to haloperidol and placebo in the~     treatment of psychomotor confusion in patients who are recovering from heart surgery.~      Study design:~      Multi-centre, prospective, randomised, placebo-controlled double-blind study of~     dexmedetomidine vs. haloperidol for treatment of psychomotor confusion after cardiac surgery.~     Data will be analyzed in two steps: The primary comparison is between placebo and~     dexmedetomidine. If the effect of dexmedetomidine is significant, a secondary comparison~     between dexmedetomidine and haloperidol will follow.~   "
185201|NCT01140516|"~     This study focuses on the relationship between prophylaxis antibiotics and frequency of~     urinary tract infection in children diagnosed with antenatal hydronephrosis. Hydronephrosis~     is the most common fetal abnormality occurring in 1-5% of all pregnancies. Currently, with~     the widespread accessibility of antenatal ultrasound across cities in Ontario, the detection~     of hydronephrosis has become even more common. As a result, thousands of infants with~     hydronephrosis have been seen and managed by pediatricians, pediatric nephrologists,~     pediatric urologists, and family physicians. The investigators need to determine if~     antibiotic prophylaxis is effective in reducing the number of urinary tract infections in~     this population.~   "
185202|NCT01140503|"~     This study is designed to evaluate the safety and efficacy of an oral medicine (called~     apremilast) for treating skin involvement in patients with the disease dermatomyositis.~   "
185203|NCT01140490|"~     The aim of this study was to evaluate whether successful sub-total parathyroidectomy retards~     cardiovascular calcification in patients with hemodialysis and to investigate the mechanism .~   "
185204|NCT01140477|"~     The objective of this clinical trial is to evaluate the safety and effectiveness of the~     Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide~     near, intermediate, and distance vision and a reduction of the effects of preoperative~     corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular~     lens (IOL) placement.~   "
185205|NCT01140464|"~     Major Depression is one of the most common mental health disorders in adolescence and is~     associated with significant impairments in development and functioning. This project will~     rigorously test the Adolescent Collaborative Care Treatment intervention, a health services~     intervention designed to improve management for depressive disorders among adolescents, via a~     randomized controlled trial comparing the intervention to usual care. Key components of the~     trial include enhanced education for youth and parents, youth involvement in choice of~     evidence-based treatments, care management by an allied health professional with regular~     supervision by a mental health specialist and pediatrician, and stepped care to advance~     treatment when youth are not improving. Additional features have been added to engage~     adolescents and parents including a moderated message board for youth to share with and learn~     from one another, formalized involvement of the parent, and availability of the care manager~     during after school hours. Our findings will provide key information on the effectiveness of~     a developmentally-sensitive adapted collaborative care intervention for the treatment of~     adolescent depression.~   "
185206|NCT01140451|"~     Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the~     cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of~     mutation called a nonsense (premature stop codon) mutation is the cause of CF in~     approximately 10% of subjects with the disease. Ataluren (PTC124) is an orally delivered~     investigational drug that has the potential to overcome the effects of the nonsense mutation.~     This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren~     (PTC124) in adult and pediatric patients with nonsense mutation CF, as determined by adverse~     events and laboratory abnormalities. The study will also assess changes in pulmonary~     function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for~     CF-related infections, CF-related disruptions to daily living, body weight, and CF~     pathophysiology. Funding Source - FDA OOPD.~   "
185207|NCT01140438|"~     The purpose of the study is to clarify whether patients classified as Latent autoimmune~     diabetes of the adult (LADA) benefit from early treatment with insulin added to per oral~     treatment and lifestyle measures.~   "
185208|NCT01140425|"~     The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A~     prolonged QT interval is a risk factor for arrhythmias.~   "
185210|NCT01140399|"~     The purpose of this study is to determine whether in patients with acute decompensated~     congestive heart failure and the cardiorenal syndrome, i.e. a state in which therapy directed~     to improve symptoms is limited by further worsening renal function, fluid removal by~     ultrafiltration is superior to different pharmacological approaches in acutely relieving~     congestion and preventing further deterioration in renal function and whether it results in~     longer admission-free survival 90 days after enrolment~   "
185211|NCT01140386|"~     The issue to be studied is the prevalence of venous thromboembolism (VTE) in hospitalized~     pediatric patients, and to identify if there are subgroups of patients who may be at higher~     risk.~      There are two hypotheses that will be looked at in this study. The first hypothesis is that~     individual risk factors for VTE in hospitalized pediatric patients are: age >14, obesity,~     black race, female sex, presence of a central venous line (CVL), traumatic mechanism of~     injury, orthopaedic surgery, and use of oral contraceptives.~      The second hypothesis is that risk factors have an additive effect such that risk~     stratification can be developed to identify those patients with the highest risk.~   "
185212|NCT01140373|"~     This is a phase I study which will test the safety of different doses of the patients own~     immune cells which have been changed to help recognize and destroy the cancer cells. The~     investigators want to find out what effects, good and/or bad, it has on the body and on the~     prostate cancer. The immune cells (T cells) used in this study will be the patients own~     immune cells. They will be removed from the patients blood, changed in the laboratory, and~     then put back into their body. T cells help the body fight infections. These cells may also~     kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer~     cells. For this reason, the physician will change the T cells by putting in a gene so that~     they may be able to better recognize and kill the prostate cancer cells. A gene is a portion~     of information which comes from the DNA and tells the cell what to do. This gene will be put~     into the patients T cells by a weakened virus. It is hoped that this approach will help the T~     cells recognize the prostate cancer tumor cells and possibly kill them. The investigators~     have found that T cells modified in this way were able to cure a cancer similar to Chronic~     Lymphocytic Leukemia in mice. However, this is an entirely new treatment for prostate cancer~     and it is not known if it will have any beneficial or unexpected harmful effects.~   "
185213|NCT01140360|"~     This is a second Pilot Study to determine the efficacy of Gleevec® in neurofibromatosis (NF1)~     patients with plexiform neurofibromas using new response assessment modalities with the~     secondary goals of assessing Gleevec toxicity, and characterizing markers of response. The~     rationale for this study arises from the response of human and murine NF1 cells to Gleevec®~     in vitro, the response of a NF1 patient treated with Gleevec® for airway compression by a~     plexiform neurofibroma with a dramatic response not previously seen in NF1 therapy, and the~     experience in 37 NF1 patients treated with Gleevec® in the initial pilot study. Gleevec will~     be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2~     or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the~     dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum~     dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of~     55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid. Treatment~     will continue for 6 months with an option to continue for 24 months if the patient is~     deriving a clinical benefit.~   "
185214|NCT01140347|"~     This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of~     ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison.~      Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and~     diagnosed with hepatocellular carcinoma will be randomized. Participants must have received~     sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have~     discontinued sorafenib prior to entering the study.~      Hypothesis: This sample size will allow differentiation of the expected increase in median~     overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab~     arm.~      Upon registration and completion of screening procedures, eligible participants with HCC who~     have disease progression during or following first-line therapy with sorafenib, or were~     intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo.~      The treatment regimen will be continued until radiographic or symptomatic progression, the~     development of unacceptable toxicity, noncompliance or withdrawal of consent by the~     participant, or investigator decision.~   "
185215|NCT01140334|"~     The purpose of the study is to evaluate methods to help people in substance abuse treatment~     receive better psychiatric care. Patients enrolled in the study will be offered three months~     of standard psychiatric treatment, which consists of weekly individual counseling and group~     counseling, as well as regular appointments with a psychiatrist. Patients will be randomly~     assigned to standard psychiatric care or standard psychiatric care plus voucher incentives.~     These incentives can be earned by successfully attending all scheduled psychiatric~     appointments each week. The investigators expect that patients in the voucher condition will~     attend more psychiatric sessions, which will lead to greater reductions in psychiatric~     distress.~   "
185216|NCT01140321|"~     An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and~     safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and~     Severe Thalassemia Intermedia.~      Efficacy and safety of the drug will be evaluated measuring at every visit this parameters:~        -  haematological: Haemochrome~        -  blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total~          proteins.~      The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and~     their follow-up will be evaluated at the beginning of the study vs 24 months through physical~     examination, abdominal echography and fundus oculi examination.~      During the trial other known risks factors for osteoporosis will be recorded, including~     prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1.~      At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to~     evaluate of the presence of bone deformities.~      Furthermore data regarding QOL and symptom pain will be evaluated trough administration of~     scale SF-36.~      At 12 months an intratrial analisis will be performed on efficacy and safety parameters in~     order to introduce possible amendments to the study design and to decide the prosecution of~     the trial~      During the trial all adverse events will be recorded~   "
185217|NCT01140308|"~     Statins (such as simvastatin or Zocor) are the most effective and widely prescribed~     medications to lower cholesterol levels and reduce the frequency of heart attacks, cardiac~     deaths and strokes. Unfortunately, statins can cause muscle discomfort or pain called~     myalgia in patients treated with these drugs. These symptoms often cause patients who need~     these medications to stop taking the drug. The cause of statin muscle pain is not known, but~     it is thought that a reduction of a vitamin-like substance called Coenzyme Q10 (CoQ10) during~     statin treatment may play a role. CoQ10 is a vitamin like substance and is not a drug~     approved and regulated by the Food and Drug Administration (FDA). This study will look at the~     effects of CoQ10 supplements on individuals who develop muscle symptoms while on simvastatin.~      The investigators hope to test the hypothesis that CoQ10 supplementation compared to placebo~     in patients with documented statin myalgia reduces the intensity of pain during statin~     treatment.~   "
185218|NCT01140295|"~     The primary objective of this study is to determine whether Miralax results in a more~     efficacious preparation as compared to senna for pediatric colonoscopy.~   "
185219|NCT01140282|"~     Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.~      Purpose: This randomized clinical trial studies exercise therapy and quality of life in~     postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.~   "
185220|NCT01140269|"~     The purpose of this study is to determine if rapid early detection of the bacteria causing~     sepsis in burn patients improves patient outcomes.~   "
185221|NCT01140256|"~     Large-scale zinc supplementation studies have demonstrated highly significant positive~     effects on growth, morbidity and mortality in infants who are born small for gestational age~     (SGA). This suggests these infants may have higher postnatal requirements compared to~     appropriate for gestational age (AGA) infants, possibly due to inadequate zinc intake from~     breast milk due either to lower volume or to differences in milk zinc concentrations from~     mothers of SGA compared to AGA infants. Alternatively, SGA infants may have lower zinc stores~     at birth, which may reflect a greater postnatal requirement for optimal zinc status. It is~     thus possible that the zinc requirements of the SGA infant exceed the zinc intake that can be~     achieved from exclusive breastfeeding, which is recommended for the first 6 mo of life. The~     exchangeable zinc pool (EZP) is defined as the estimate of the total size of the combined~     pools of zinc that exchange with zinc in plasma within approximately 2-3 days and may also~     differ between SGA and AGA infants.~        1. Compare longitudinal zinc intake by measuring milk zinc concentrations and volume of~          intake of breast milk between SGA and AGA infants through first 12 mo.~        2. Compare post-natal growth rates for SGA and AGA infants through the first 12 mo of life~          in relation to zinc intake.~        3. Compare size of exchangeable zinc pool (EZP) at birth and at 6 mo of age between SGA and~          AGA infants.~      Hypotheses:~        1. Zinc concentrations in human milk will not be significantly different at any stage of~          lactation between mothers of SGA infants and mothers of AGA infants.~        2. The volume of breast milk intake relative to body weight will be similar between SGA and~          AGA infants, but the total intake will be lower in SGA infants.~        3. Linear growth rates, rate of weight gain, and rate of growth in head circumference will~          be significantly lower in infants born SGA, and will be positively correlated with total~          daily zinc intake.~        4. The size of the EZP at birth will be significantly smaller in absolute size and relative~          to body weight in infants born SGA compared to AGA~   "
185222|NCT01140243|"~     The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant~     formulas supplemented with different levels of LCPUFA, for premature infants following~     discharge from Hospital.~   "
185223|NCT01140230|"~     Few studies are considering acute traumatic rotator cuff tears in previously asymptomatic~     patients. The purpose of the current study was to investigate if delay of surgery, age at~     repair and the number of cuff tendons involved affected the structural and clinical outcomes.~   "
185224|NCT01140217|"~     The purpose of this study is to determine whether NEA TDS is effective in the prevention of~     pregnancy. The safety of this product will also be evaluated.~   "
185225|NCT01140204|"~     This was a randomized, placebo-controlled, multi-centre study, double-blind within each dose~     level, with four ascending dose levels to test the tolerability and safety of~     iopromide-paclitaxel in patients with de novo lesions in coronary arteries. Thirty-two~     patients were included into the trial, which were divided into four treatment groups. A total~     of four concentration levels of paclitaxel-iopromide concentrations were investigated. In~     each treatment group, six patients received iopromide-paclitaxel and two patients placebo~     (iopromide without paclitaxel). In each patient, the doses were adjusted individually as~     needed.~   "
185226|NCT01140191|"~     The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy~     of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects~     with cutaneous leishmaniasis (CL).~   "
185227|NCT01140178|"~     Recent literature suggests that certain patients with squamous cell cancers of the head and~     neck region may benefit from photodynamic therapy whether or not they may have received prior~     therapy, e.g. radiation therapy~   "
185228|NCT01140165|"~     The aim of this study is to examine if a diet rich in cheese will have a beneficial effect on~     risk markers of cardiovascular disease compared to a diet rich in butter.~      The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and~     triacylglycerol (TAG). The secondary parameters are hsCRP, markers of insulin resistance,~     fasting insulin and glucose (HOMA). Furthermore bloodpressure is measured.~   "
185229|NCT01140152|"~     Many patients with intestinal failure require intestinal transplantation for survival.~     Currently, the gold standard for diagnosing acute cellular rejection (ACR) is histological~     examination of endoscopic biopsies, which are taken invasively and lack sensitivity. A~     non-invasive method of monitoring for ACR is needed.~   "
185230|NCT01140139|"~     In this study, the investigators evaluated a therapeutic HIV-1 DNA vaccine administered with~     a novel topical application method to 12 chronically HIV-infected cART treated patients. The~     HIV DNA plasmids used in this study encode for envelope gp160 of HIV-1 subtypes A, B and C,~     rev B, Gag A and B and reverse transcriptase (RT) B. The patients were randomly assigned to~     three groups; group 1 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids~     topically, group 2 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically~     and treated with 500 mg of hydroxyurea daily until visit 10, group 3 (n=4) four patients~     received placebo. The immunization was performed during three cycles of 7 weeks of cART~     followed by four weeks of therapy interruption. After the last cycle of cART the patients~     were maintained on a definitive treatment interruption until CD4+ T cell counts dropped below~     350/ mm3 at two time points. Cellular and humoral immune responses, viral load and CD4+ T a~     cell count was analysed throughout the study.~   "
185231|NCT01140126|"~     The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting~     the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and~     well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous~     infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The~     neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive~     cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1~     infection.~   "
185232|NCT01140113|"~     The inflammatory response after cardiac surgery increases mortality and morbidity. Modified~     ultrafiltration (MUF) has been shown to decrease the post-cardiac surgery inflammatory~     response, to improve respiratory function, and cardiac performance in pediatric patients;~     however, this approach has not been well established in adults. The investigators therefore~     hypothesized that MUF can decrease the post-cardiac surgery inflammatory response and can~     improve cardiopulmonary function in adults.~   "
185233|NCT01140100|"~     The aim of this study is to determine whether induction of anesthesia with thiopental~     followed by propofol infusion is able to maintain sufficient depth of anesthesia .~   "
185234|NCT01140087|"~     This study aims to:~        1. Perform face transplants on people who have suffered severe facial trauma with tissue~          and functional loss; and~        2. Evaluate the acceptance and function of the transplanted tissue.~   "
185235|NCT01140074|"~     Diarrheal disease is one of the major causes of morbidity and mortality in children under~     five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In~     children with severe zinc deficiency, diarrhea is common and responds quickly to zinc~     supplementation. Zinc supplementation may also helpful in diarrheal children without zinc~     deficiency. Effectiveness of zinc was proven in developing countries but was not in Europe.~     Objective of our study is to assess whether zinc supplementation given with probiotics and~     ORS is effective in acute diarrhea in children in Poland.~   "
185236|NCT01140061|"~     This study will evaluate the incidence of erythema and other local cutaneous irritation after~     administration of MK-0873 by patch or cream formulation in healthy participants and~     participants with mild psoriasis. Part I and Part II in healthy participants will be~     initiated prior to Part III in psoriasis participants. The primary hypotheses of the study~     are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with~     psoriasis and 2) that the maximum plasma concentration of MK-0873 is <20 nM in healthy~     participants and participants with psoriasis.~   "
185237|NCT01140048|"~     This is a prospective, multicenter, observational study in participants who completed the~     24-week, placebo-controlled MK-0476 Protocol 272 (NCT00076973) study of montelukast in the~     treatment of respiratory symptoms subsequent to RSV-induced bronchiolitis. The purpose of~     this study is to better understand the clinical and demographic correlates of asthma and~     atopic disorders in children (through the age of 6 years) with a history of severe~     RSV-induced bronchiolitis.~   "
185238|NCT01140035|"~     Every year in the US, there is a shortage of many thousands of kidneys needed for transplant.~     Furthermore, kidneys that are available and are transplanted often exhibit delayed or slow~     graft function (DGF and SGF, respectively), which lowers quality of life for patients and~     their families and requires significant additional medical care. These needs result in~     significant but preventable human suffering and health care spending. To address these needs,~     the investigators' project will test the use of intensive insulin therapy (IIT) in donors~     after neurological determination of death (DNDDs) as an intervention that will decrease acute~     kidney injury and improve renal function at the time of organ recovery. This should translate~     into a decreased incidence of DGF and SFG in recipients receiving organs from the IIT group.~     The investigators also expect to find a trend toward an increase in the number of organs~     available for transplant due to better organ protection in the DNDD. Taken together, these~     data can provide the requisite justification for a larger study that can be powered to~     evaluate the effect of IIT on increasing the number of kidneys available for transplantation.~      There is evidence that brain death often leads to hyperglycemia that may negatively impacts~     the organs of DNDDs. These observations led us to conduct a retrospective study, in which the~     investigators found that hyperglycemia in DNDDs is indeed associated with decreased terminal~     renal function. Because it has been reported that intensive insulin therapy (ITT) is~     renoprotective in the ICU more than conventional insulin therapy (CIT), the investigators~     propose to evaluate the use of IIT on DNDDs to: (1) improve organ function, (2) reduce DGF in~     recipients, and (3) possibly increase the number of kidney available for transplant.~      Methods: This is a prospective observational study to document the impact of IIT on acute~     kidney injury in DNDDS and on allograft function in recipients. DNDDs will be divided into~     two groups: CIT and IIT. In the first study, the investigators will evaluate the effect of~     ITT on biochemical parameters in blood samples that predict kidney health and function in~     DNDDs. All methods used in this proposal are well documented in the literature and~     established in the applicant's laboratory. In the investigators' second study, they will~     compare the effects of ITT in DNDDs on graft function in allograft recipients in terms of~     number of patients showing either DGF or SGF. Additionally, there is currently no established~     set of advanced biochemical criteria in DNDDs for predicting kidney function in recipients.~     The investigators will correlate the evaluated biochemical markers of kidney function and~     health in order to possibly develop more refined methods of predicting transplant success.~     Such a set of criteria would be useful for designing studies to systematically test~     additional interventions in DNDDs to further improve organ function before recovery and~     further increase the number of available organs.~      Taken together, the results of this study may lead to new therapies that significantly~     improve patient outcomes while significantly reducing disease associated costs. These results~     can also set the stage for a follow on study for increasing the number of kidneys available~     for transplant.~   "
185239|NCT01140022|"~     The purpose of this study is to conduct a quality improvement intervention to improve the~     ability of health care providers to deliver an important preventive health service (CT~     screening) in order to meet the goal of universal CT screening for young women age 25 or~     younger as recommended by the CDC and virtually all major health organizations. This novel~     approach utilizes a bilingual (English-Spanish) computer kiosk module to deliver education~     about CT and allow patients to request a CT screening test. This module should significantly~     increase CT screening among at risk women (18-25yo) attending urgent care clinics and~     emergency departments.~   "
185240|NCT01140009|"~     The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1~     pandemic of 2009. Many Canadians either had the H1N1 infection or the adjuvanted H1N1~     vaccine. Both H1N1 infection and adjuvanted vaccine produced strong immune responses which~     could last for some time.~      The seasonal influenza vaccine for this fall will be a normal product once again, without~     adjuvant. It will contain 3 strains of killed, split-apart viruses that might circulate this~     winter, including the H1N1 pandemic strain. It is theoretically possible that giving the~     H1N1-containing seasonal vaccine to people who still have some immunity to H1N1 virus could~     result in more frequent side-effects. However, there is no good evidence that pre-existing~     immunity to a strain in the vaccine does increase side-effects. In short, there could be~     nothing out of the ordinary this fall but it would be prudent to check this before public flu~     vaccination programs begin.~   "
185241|NCT01139996|"~     This study will attempt to learn how to better treat trauma patients with delirium who are on~     a breathing machine. Delirium, also known as acute, temporary brain dysfunction, is a common~     reason why ventilated patients can not be weaned from the breathing machine even though their~     lungs may be healthy enough to breathe without the machine. The study hopes to show that by~     decreasing the patient's delirium it will lead to quicker weaning from the breathing machine~     and possibly a quicker overall recovery as well. Patients enrolled in this study will be~     treated with Clonidine or placebo. Clonidine is a drug that produces significant calming~     effects, decreases anxiety, and reduces pain, but with a lower incidence of delirium than~     other medications used in the ICU for this purpose. Clonidine is not approved by the Federal~     Food and Drug Administration for treatment of delirium, but is commonly used for this~     purpose.~   "
185243|NCT01139970|"~     This phase I clinical trial is studies the side effects and best dose of giving veliparib~     together with temozolomide in treating patients with acute leukemia. Veliparib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving veliparib~     together with temozolomide may kill more cancer cells.~   "
185244|NCT01139957|"~     This clinical trial is studying the incidence of cancer in women at increased genetic risk of~     ovarian cancer. Gathering information about genetic factors in women with an increased risk~     of ovarian cancer over time may help doctors learn more about the disease and find better~     methods of treatment and on-going care.~   "
185245|NCT01139944|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tissue and blood samples from patients~     with early-stage non-small cell lung cancer.~   "
185246|NCT01139931|"~     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the~     laboratory may help doctors learn about changes that occur in DNA and identify biomarkers~     related to cancer.~      PURPOSE: This research study is studying biomarker changes in samples from young patients~     with acute myeloid leukemia.~   "
185247|NCT01139918|"~     This exploratory study will be used to identify questions that will be part of a new QoL~     questionnaire for patients with psoriasis and psoriatic arthritis and to determine the sample~     size needed for its validation. The new questionnaire will be a global QoL questionnaire~     which will take into account the impact of both psoriasis and psoriatic arthritis on QoL.~      STUDY OBJECTIVES~        -  To evaluate the influence of psoriasis and psoriatic arthritis on patient's answers to~          QoL questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36.~        -  To identify an equal number of questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36~          where answers are mostly influenced either by psoriatic arthritis or by psoriasis.~   "
185248|NCT01139905|"~     To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai~     children.~   "
185249|NCT01139892|"~     Purpose:~      Phase 1: (Pilot Phase)~      To compare the treatment efficacy of surgical clipping and endovascular coiling for~     unruptured intracranial aneurysms.~      To obtain better estimates of morbidity and mortality related to a surgical or endovascular~     treatment strategy at one year within the context of an RCT.~      To show that an RCT comparing the morbidity and mortality of a surgical management strategy~     to an endovascular management strategy is feasible.~      Phase 2:~      To compare the results of surgical and endovascular management strategies, in terms of:~        1. Overall mortality and morbidity at 1 and 5 years.~        2. The clinical efficacy and safety of a surgical or endovascular management strategy at 1~          and 5 years~      Hypotheses: Phase 1 Hypotheses:~        1. Surgical clipping of intradural, saccular, unruptured intracranial aneurysms is superior~          to endovascular management in terms of a lesser number of patients experiencing~          treatment failure.~        2. An RCT comparing the clinical outcomes of a surgical versus endovascular management~          strategy is feasible.~      Phase 1 Primary End-points:~      • Treatment failure, hereby defined as having occurred when either: the intended initial~     modality (surgical or endovascular) fails to occlude the aneurysm, a major (saccular)~     angiographic aneurysm recurrence is found, or an intracranial hemorrhagic event occurs during~     the 1-year follow-up period.~      Phase 1 Secondary End-points:~        1. Overall morbidity and mortality at one year.~        2. Occurrence of morbidity (mRS >2) or mortality following treatment.~        3. Occurrence of failure of aneurysm occlusion using the initial intended treatment~          modality.~        4. Occurrence of a major (saccular) angiographic aneurysm recurrence.~        5. Occurrence of an intracranial hemorrhage following treatment.~        6. Peri-treatment hospitalization lasting more than 5 days~        7. Discharge following treatment to a location other than home~      Treatment:~      Trial feasibility, or the capacity for patient recruitment, would require enrollment of at~     least 8 patients per actively recruiting center per year.~      Phase 2 Hypotheses:~      It may be too early to explicitly define the primary hypothesis of Phase 2, however, the~     intent of Phase 2 can be expressed as:~        1. One management strategy is superior to the other in terms of clinical outcome at five~          years.~        2. One management strategy is superior to the other in terms of clinical efficacy at five~          years.~   "
185250|NCT01139879|"~     To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the~     treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the~     home care and extended care (nursing home) environment.~   "
185251|NCT01139866|"~     This is an extension to a previous research trial testing SABER™-Bupivacaine (an experimental~     pain-relieving medication). The purpose of this extension trial is to assess whether~     treatment with SABER™-Bupivacaine or SABER™-Placebo has had any effect on healing of the~     participant's shoulder, wound, or the skin near their scar. This trial will also assess~     safety (side effects).~   "
185252|NCT01139853|"~     The overall objective of this research study is to determine the effect of a pre-operatively~     placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and~     postoperative length of stay in infants with a primary diagnosis of pyloric stenosis treated~     with pyloromyotomy. This study will also examine the feasibility data of the pilot data to~     develop estimates of treatment effect of a pre-operative nasogastric tube on post-operative~     rate of emesis and length of stay to be used to determine the sample size of the definitive~     trial.~   "
185253|NCT01139840|"~     Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the~     same dose of vitamin D3.~   "
185254|NCT01139827|"~     Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But~     it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron~     emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation~     within atherosclerotic plaques and hsCRP is also arising detection tool of CV risk.~      The investigators are examining this association in normal and impaired glucose tolerance~     patients groups.~   "
185255|NCT01139814|"~     The purpose of this clinical study is to collect safety and performance data to support a~     demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to~     predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).~   "
185256|NCT01139801|"~     The purpose of this study is to specifically investigate the efficacy of an alternative~     pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an~     adjunct to Foley balloon for induction of the unfavorable cervix.~   "
185257|NCT01139788|"~     Study CXBA is a multicenter nonrandomized, dose escalation, open-label, Phase 1 study of~     intravenous LY2624587 in patients with advanced or metastatic cancer for which no treatment~     of higher priority exists.~   "
185258|NCT01139775|"~     LY2603618 is a selective inhibitor of the deoxyribonucleic acid (DNA) damage checkpoint~     kinase 1 (CHK1). It was being developed as a chemotherapeutic-enhancing agent in the~     treatment of cancer. Phase 1 studies have shown the feasibility of combining LY2603618 with~     either gemcitabine or pemetrexed. The objective of this study was to find the dose of~     LY2603618 that can be safely combined with standard doses of pemetrexed and cisplatin and to~     test if this triplet offered a significant improvement in progression-free survival (PFS) in~     participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) in the first-line~     of palliative treatment.~   "
185260|NCT01139749|"~     Oral isotretinoin is the gold standard drug to treat moderate to severe acne. Other~     indications like seborrhea, seborrheic dermatitis have been suggested. There is risk of~     reversible mucocutaneous side effects, as well as alterations in lipid profile and~     transaminases. The major problem is teratogenicity which demands pregnancy control from~     treatment beginning to one month after treatment end. Seborrhea and seborrheic dermatitis are~     chronic conditions characterized by oily skin, hair and scalp, erythema, desquamation and~     negative impact on quality of life. This will be an interventional, therapeutic and quality~     of life randomized, comparative (parallel groups), blinded evaluation clinical trial,~     comprising 50 men and women, aged 18 to 40. Treatment with low-dose oral isotretinoin will be~     compared to topical anti-seborrheic products to evaluate the reduction of sebaceous secretion~     and colonization of affected areas by yeasts of Malassezia gender. Efficacy will be evaluated~     by clinical parameters, as well as by sebum secretion measure and application of quality of~     life questionnaires. Safety will be evaluated by skin hydration measure, side effects report~     and observation. For subjects using oral isotretinoin blood counting, transaminases, lipid~     profile and pregnancy test will be requested as selection criteria, on days 30 and 180. Data~     will be submitted to statistical analysis.~   "
185261|NCT01139736|"~     Irritable bowel syndrome is a common digestive disorder worldwide. However, there is no~     effective treatment of irritable bowel syndrome. Visceral pain thresholds in response to~     stress are lower in patients with IBS compared to healthy volunteers, but the triggers to~     visceral hypersensitivity remain largely unknown. Animal models suggest roles for both host~     immune response and intestinal bacteria in the induction of visceral hypersensitivity. For~     instance colorectal distension increased in association with an alteration in bacterial flora~     induced by antibiotic therapy, which suggest a relationship between bacterial gut content and~     visceral afferent processing. Intestinal bacteria play a significant role in inducing IBS.~     Clinical studies have shown that manipulation of the commensal microbiota with probiotic~     bacteria, in particularly preparations that contain bifidobacteria, can alleviate IBS~     symptoms. Serotonin (5-HT) plays a crucial role in the regulation of gastrointestinal~     physiology and alterations in mucosal serotonin signaling is a possible mechanism of altered~     function and sensation in patients with IBS. Impairment of serotonin reuptake transporter~     (SERT) expression and function may also play a role in IBS. The investigators hypothesise~     that bacteria modulate sensory afferent and serotonin signaling necessary for visceral~     sensation and that these pathways can be targeted for therapy of IBS using probiotic~     bacteria. The first part of this study will be a cross-sectional study comparing the colonic~     microbiota and SERT polymorphisms in IBS patients and healthy controls. The second part will~     be an open-label pilot study to assess the effects of oral probiotic bacteria in visceral~     hypersensitivity and mucosal microbiota in patients with IBS. Clinical response will be~     assessed based on IBS symptom score and rectal sensitivity, and changes in mucosa microbiota~     will be measured using 454 pyrosequencing. This proposal will provide novel data on gut~     microbiota in Asian IBS patients, and explore the mechanisms underlying visceral~     hypersensitivity to direct future targeting of therapy in IBS.~   "
185262|NCT01139723|"~     This is a Phase I, first-in-human, open label, dose-escalation study of MINT1526A~     administered alone and in combination with bevacizumab by IV infusion every 3 weeks to~     patients with advanced solid tumors for whom standard therapy either does not exist or has~     proven to be ineffective or intolerable.~   "
185263|NCT01139710|"~     This prospective study was conducted to explore clinical characteristics and outcomes of~     patients diagnosed with pulmonary sarcoidosis and PH. The investigators also assessed the~     role of D -dimer levels in these population.~   "
185264|NCT01139697|"~     The purpose of this study is to determine whether hair cortisol and testosterone levels~     correlate with heart failure status in patient with chronic congestive heart failure.~   "
185265|NCT01139684|"~     A test of the validity of repeated sprint test (RST) 4x 30 meters, against the Wingate~     Anaerobic Test, which is the gold standard for measuring human anaerobic capacity. The~     following variables will be used: peak power, mean power and fatigue index. In addition, it~     will be tested against a 50 meter and a 200 meter shuttle run.~   "
185266|NCT01139671|"~     Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery.~      The choice of opioid in dental day surgery is based on the need for a rapid and full~     recovery, as well as less morphine administration. Whether remifentanil can achieve these~     goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the~     potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload~     for nurses.~   "
185267|NCT01139658|"~     Observational cohort study on the prevention of venous thromboembolic events after elective~     orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated~     with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions~   "
185268|NCT01139645|"~     This prospective, single-blind, matched controlled study aims to evaluate the effect of~     proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to~     establish additional biological plausibility for the apparent association between proton pump~     inhibitors (PPIs) and osteoporosis-related fractures.~      Young males (age 18-45 years), who are either healthy volunteers, or who complain of daily or~     frequent heartburn but are otherwise healthy, will be recruited and enrolled in the study.~     Patients with heartburn will be assigned to the intervention group and will be assigned to~     take a PPI for three months. Healthy volunteers will be matched by age to patients in the~     intervention group and will act as the control group. 70 patients will be enrolled in total.~     Blood studies for all subjects will be taken at 0, 1 and 3 months to test for various~     biochemical markers of calcium and bone metabolism, which act as surrogate markers of calcium~     absorption and bone remodeling.~      Levels of biochemical markers in the two groups will be compared using two-way analysis of~     variance (ANOVA). Changes in biochemical parameters within a group will be assessed using~     repeated measures ANOVA.~   "
185269|NCT01139632|"~     The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is~     CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population.~     The aim of the investigators study is to diagnose early coronary artery disease in NAFLD~     patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with~     patients with combination of CAD, unstable plaque and NAFLD.~   "
185311|NCT01139073|"~     The B/B Checker, a new portable device for detecting odorous compounds in oral, exhaled, and~     nasal air, is now available. As a single unit, this device is capable of assessing several~     kinds of gases mixed with volatile sulfur compounds (VSCs) in addition to other odorous~     gasses. The purpose of the present study was to evaluate the effectiveness of the B/B Checker~     for detecting the malodor level of oral, exhaled, and nasal air.~   "
185480|NCT01136824|"~     Assessments (survey data) in this study are designed to sample the symptom burden of patients~     undergoing adjuvant and neoadjuvant chemotherapy in the hospital. There will be no change in~     the treatment plan for these patients.~   "
185270|NCT01139619|"~     Lung cancer is one of the most deadly types of cancer and the leading cause of death in~     cancer in Sweden. Five year survival is 10% in men and 15% in women. Approximately 3300~     individuals in Sweden are diagnosed each year and the incidence of adenocarcinoma is~     increasing. Lung cancer patients are to a great extent currently being diagnosed by~     exfoliative cytology. However, new drugs leading to more personalized treatments will demand~     more specific classification of tumour types. Today EGFR mutation status is becoming an~     important factor when deciding treatment strategy for patients with Non-Small Cell Lung~     cancer.~      Sufficient tumour material must be available if EGFR mutation status is to be tested. Core~     needle biopsy is one way to obtain the quantity of material needed when testing mutation~     status. The portion of patients having core needle biopsies is believed to vary greatly~     between hospitals in Sweden, a difference from 20% to 70 % have been assumed, but is not yet~     confirmed in studies. This study will investigate the current situation and procedures when~     patients are diagnosed with lung cancer. The results can be used to describe any possible~     adverse events connected to the procedure and possibly contribute to development of a better~     decision tool to be used when deciding if a core needle biopsy is to be performed or not.~      More and more therapeutical targets having similar problems are likely to be developed in the~     future. An investigation of current quality and procedures when diagnosing lung cancer by~     biopsies will facilitate future diagnosing of lung cancer and ensure that personalized~     treatments can be offered to patients.~   "
185271|NCT01139606|"~     Introduction:~      Vibration has been used to enhance muscle strength development during resistance training.~      Aim:~      To assess the effect of adding vibration to a regular resistance training program, using free~     weights, on muscle strength and everyday functioning of upper limbs in untrained adults~      Methods:~      60 healthy untrained adults, 30-65 yrs, will divide into two groups: experiment and control.~     Training program will include 24 sessions, over a course of 8 weeks. The experiment group~     will use a 1 kg vibrating weights and the control group will use a standard 1 kg free~     weights. Every session will include 10-15 min of 3-5 standard resistant exercises for upper~     limbs. Each subject will perform an Isokinetic evaluation of muscular performance, for upper~     limbs, in 3 occasions: before starting the program, immediately after completing the 8-weeks~     training program and 4 weeks afterwards, to check the chronic effect of each training regime.~     Each subject will complete a DASH (Disabilities of the arm, shoulder and hand) questionnaire~     at 4 occasions- as mentioned above and one more time, when completing the first 4 weeks of~     the training program, to reject any development of negative effects of the training program,~     such as pain or inflammation of the joints .~   "
185272|NCT01139593|"~     This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI~     when taking their gonadotropin dosage in the morning (am) or evening (pm).~   "
185273|NCT01139580|"~     The purpose of this study is to determine the safety and effectiveness in the treatment of~     psoriasis on the scalp and on the body.~   "
185274|NCT01139567|"~     The purpose of this study is to investigate the safety and efficacy of an optical device~     designed and developed to quantitatively monitor blood flow velocity of wound sites. The~     hypothesis is that the blood flow velocity of the wound site will provide critical~     information on the efficacy of hyperbaric oxygen therapy.~   "
185275|NCT01139541|"~     The purpose of the study is to learn more about effective ways to motivate people to increase~     their non-exercise energy expenditure exercise. This is an important research question~     because obesity and weight-related issues are increasingly becoming a problem in America.~     This project will address this research question by testing the effect of group dynamics in~     motivating employees who are predominantly sedentary to use Walkstations at work. The~     Walkstations are treadmills that move at a very slow rate (maximum 2miles / hour) and are~     attached to a work station (i.e. with computer and telephone); they therefore are designed to~     increase energy spent not through heavy exercise, but through small changes in posture and~     movement associated with routines in daily life (called nonexercise activity thermogenesis or~     NEAT). The proposed study is designed to build upon previous research (Levine et al., 2005)~     suggesting the role of NEAT-enhanced behaviors in weight loss.~      In this study, the investigators are interested in the impact of group dynamics on the~     propensity to use the Walkstations. Participants in the active arms will be asked to use the~     Walkstations for at least 3 hours per week. They will do so by signing up for a time slot.~     During their session, they will be asked to log into the scheduling system to indicate that~     they are using the Walkstation. Walkstation usage will be assessed by log-in data: employees~     will log-in to the phone and computer when they use the Walkstation. This log-in data is~     work-station specific; therefore the investigators will be able to tell when a given subject~     used the Walkstation.~      Subjects will be randomly assigned to one of three conditions:~        1. Individual. In the individual condition, participants will not be part of a team. They~          will receive weekly email feedback on their Walkstation performance (e.g. number of time~          slots they signed up for, and number of times they showed up for the time slot.)~          Participants will also receive a wellness tip in each email. (see appendix for a sample~          email)~        2. Pairs. In the pair condition, participants will be randomly assigned to a partner. They~          will receive the same feedback as those in the individual condition, for both themselves~          AND their partner.~        3. Group. In the group condition, participants will be randomly assigned to a group of 5~          people. They will receive the same feedback as those in the individual condition, for~          both themselves AND each member of their group.~   "
185276|NCT01139528|"~     A multi-site randomized controlled trial where patients are allocated to operative treatment~     or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal~     is to identify which degree of angular displacement in the fracture that requires operative~     intervention.~   "
185277|NCT01139515|"~     The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK)~     characteristics to those seen in other populations.~   "
185278|NCT01139502|"~     This study will compare the effects of cognitive behaviour therapy (CBT) and cognitive~     training in work rehabilitation of patients with severe mental illness (psychoses).~      These interventions will be compared with a matched control group ('treatment as usual'). The~     patients will be recruited in nine different counties in Norway. During a two-year period~     around 27-30 patients can be recruited from each county, meaning that each intervention arm~     will contain approximately 80 patients. The evaluation of the patients will include several~     validated diagnostic instruments as described below. The counties has been randomised to the~     two different intervention groups by a neutral institution: 1.group receiving work~     rehabilitation based on cognitive behaviour therapy, and 2.group receiving cognitive~     training. The control group will be matched according to gender and age. With Ntotal=160 for~     the comparison of two groups (80 patients x 2), a 0.05 level of significance and a power of~     0.80, a standardised group difference of 0.44 can be detected. The standardised difference~     detected between supported employment and treatment as usual has been as high as 0.80 in~     comparable American studies, indicating that N is large enough in the present study.~      The participants in each county will be evaluated and followed by a local project coordinator~     and by a local psychiatrist/psychologist in a District Psychiatric Centre. Written evaluation~     protocols will be sent anonymously to the research centre for registration. Data will be~     stored according to current laws of person protection and data security. Pre-post differences~     in each group, differences between the control group and the intervention groups, and~     differences between the intervention groups will be tested using a mixed linear model~     programme.~      Research questions The project will compare the effects of CBT oriented work rehabilitation~     and work rehabilitation with cognitive training with regard to the ability of persons with~     severe mental disorders to cope with and keep a job. The two intervention arms will be~     compared with each other and with a matched treatment as usual control group.~      Main hypotheses~        1. By the end of the project (T2) and by follow up examination (T3) the global psychosocial~          function of patients will be higher in the CBT work rehabilitation group than in the~          control group~        2. The global psychosocial function of patients at T2 and T3 will be higher in the~          cognitive training group than in the control group~   "
185279|NCT01139489|"~     This is a randomized controlled trial comparing standard-of-care therapy of infections in~     critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics~     consumption) and safety (mortality).~   "
185280|NCT01139476|"~     Background:~      - Multiple myeloma (MM), a type of cancer that affects the white blood cells, is often~     preceded by a precancerous disorder known as monoclonal gammopathy of undetermined~     significance (MGUS). Farmers and other agricultural workers have a higher risk of developing~     MGUS and MM, possibly because of their exposure to certain pesticides. Researchers are~     interested in studying biological specimens taken from participants in the Agricultural~     Health Study - specifically, pesticide applicators at least 50 years of age who do not have~     cancer- to better understand the development of MGUS and MM.~      Objectives:~        -  To collect biological specimens from Agricultural Health Study participants for further~          research.~        -  To examine the relationship between pesticide exposure and MGUS/MM.~      Eligibility:~      - Male pesticide applicators who are over 50 years of age, cancer-free, and participating in~     the Agricultural Health Study.~      Design:~        -  Two groups of participants will complete the study: a general group and a smaller group~          of individuals who have been exposed to the pesticide diazinon.~        -  All participants will receive an initial contact letter with information about the~          study, followed by a phone call to administer a screening questionnaire and arrange a~          home visit from a researcher within the next month.~        -  Participants will receive by mail a urine specimen kit that will be collected at the~          home visit.~        -  During the home visit, a study researcher will take blood samples and collect the urine~          sample, and will administer another questionnaire.~        -  Participants in the group exposed to diazinon will have three home visits for the study:~          (1) prior to pesticide exposure, (2) the day after participants stop using diazinon, and~          (3) about 21 days after the second visit. The first visit will take place in the~          off-season from January to March; the second and third visits will be conducted between~          April and August.~        -  No treatment will be provided as part of this study.~   "
185281|NCT01139463|"~     Blood lactate levels in patients receiving typical or atypical antipsychotics have not been~     described in the literature.~      The goal of this study is to assess the dynamics of lactate levels in the blood from typical~     or atypical antipsychotics not confounded by prior antipsychotic treatments, the~     investigators conducted a prospective study of lactate levels in patients receiving~     antipsychotic medication. The investigators hypothesized that 6 months of treatment with~     haloperidol or olanzapine would result in a change in blood lactate levels and extrapyramidal~     side effects.~   "
185282|NCT01139450|"~     The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic~     Dermatitis.~      Treatment medication will be administered as follows: Apply a thin layer of ointment to~     affected skin areas twice daily and rub in gently and completely. Study medication will be~     applied twice a day, approximately 12 hours apart, for approximately 4 weeks.~   "
185283|NCT01139437|"~     Human parainfluenza virus type 2 (HPIV2) can result in severe respiratory illness in infants~     and young children. This study will test the safety of and immune response to an HPIV2~     vaccine aimed at infants and children.~   "
185284|NCT01139424|"~     Patients with suspected leakage at the specified surgical anastomoses undergo an immediate~     diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the~     inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to~     standard surgical care.~   "
185285|NCT01139411|"~     The purpose of the study is to determine whether a novel model of including parents in~     adolescent weight control results in greater decrease in adolescent z-BMI compared to an~     intervention with minimal parent involvement.~   "
185286|NCT01139398|"~     The purpose of this study is to validate the effectiveness of food supplement Limicol on~     reducing LDL-cholesterol in moderate hypercholesterolemic volunteers.~   "
185287|NCT01139385|"~     The aim of this study was to compare between the safety and efficacy of the harmonic shears~     and the commonly used clip technique in achieving safe closure and division of the cystic~     duct in the laparoscopic cholecystectomy in day surgery setting~   "
185288|NCT01139372|"~     The purpose of this study is to describe the subjective assessments of an investigational~     lubricant eye drop.~   "
185289|NCT01139359|"~     This study is a Phase I trial of Darinaparsin in combination with CHOP for the treatment of~     lymphoma. Eligible patients will not have had any previous anti-cancer treatment and will be~     eligible to receive CHOP alone.~   "
185290|NCT01139346|"~     This study is a Phase I, dose escalation study of oral darinaparsin for the treatment of~     advanced solid tumors. Eligible patients could have received any amount of previous therapy.~   "
185291|NCT01139333|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research study is studying blood and tumor tissue samples from young patients~     with acute myeloid leukemia.~   "
185292|NCT01139320|"~     RATIONALE: Studying samples of DNA from patients receiving gemtuzumab ozogamicin may help~     doctors learn more about the effects of gemtuzumab ozogamicin on cells. It may also help~     doctors understand how well patients respond to treatment.~      PURPOSE: This research study is studying biomarkers in DNA samples from younger patients with~     newly diagnosed with acute myeloid leukemia receiving gemtuzumab ozogamicin.~   "
185293|NCT01139307|"~     RATIONALE: Studying samples of blood or tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research study is studying biomarkers in samples from patients with Down~     syndrome and acute megakaryoblastic leukemia.~   "
185294|NCT01139294|"~     The purpose of this study is to non-invasively study the reflective changes in cardiac output~     as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric~     patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and~     electrolytes compared to intravenous methods.~   "
185295|NCT01139281|"~     The proposal of this study was to evaluate in human beings, using distortion product~     otoacoustic emission (DPOAE) test, the action of ginkgo biloba extract (GBE761)as a possible~     ear protective against cisplatin (CDDP) induced hearing loss.~   "
185296|NCT01139268|"~     Infertility affects an increasing number of couples. For many, the choice of treatment is in~     vitro fertilization (IVF) . Currently, there are no markers fully predictive of developmental~     competence of IVF embryos. Present embryo selection is based on morphology assessment, which~     produces implantation rates in the range of 20%-30 %. The overall purpose of the present~     study is to investigate methods for selection of the best embryo. We aim to examine the~     relationship between pregnancy outcome and the transcriptional profile of selected genes,~     cleavage kinetics (time-lapse), and metabolic profile. We hypothesise that the quality of the~     embryo is reflected by the transcription of selected genes, the cleavage kinetics, and the~     metabolic profile. If so, these parameters can predict the success or failure of a pregnancy.~     Furthermore, the interrelationship - if any - between these parameters will be evaluated.~      A secondary aim is to evaluate the effect of blastomere biopsy using time-lapse and metabolic~     analysis~   "
185342|NCT01138657|"~     A study comparing the safety and efficacy of adalimumab compared with placebo in patients~     with active uveitis.~   "
185297|NCT01139255|"~     Overweight and obesity play a role in both cancer incidence and survival rates. Many people~     have found attending weight loss support groups to be time-intensive. Past research has shown~     electronic media, particularly the Web, to be effective in producing weight loss. The Web,~     however, lacks portability, which prevents people from accessing the information when it is~     convenient for them. Providing weight loss information via podcasting (audio files that may~     be listened to on portable audio players) may allow people to receive weight loss tips~     anywhere. A previous research study showed that podcasts emphasizing healthy eating and~     exercise can help people lose weight. This study was short-term and did not include~     additional social support. The purpose of this research project is to assess the~     effectiveness of a weight loss intervention delivered through podcasts as compared to the~     same podcast with added mobile media such as self-monitoring software (such as a pedometer)~     and support delivered via a social networking site. For this research study, the~     investigators will conduct a 6-month study in 104 overweight adults to determine if a podcast~     plus mobile media support leads to greater weight loss than a podcast alone.~   "
185298|NCT01139242|"~     This is an intervention study to increase colorectal cancer screening and physical activity~     in members of African-American churches who are 50 years old and older. The control arm~     receives the Body & Soul program, a program to increase fruit and vegetable intake. The~     investigators hypothesize that those receiving the intervention, which includes four tailored~     newsletters and peer counseling, will be more likely to be screened if not up-to-date, and~     more likely to increase physical activity if screening was up-to-date at baseline, than~     controls.~   "
185299|NCT01139229|"~     The investigators improved the hybrid everted esophagogastrostomy and expected to prevent the~     incidence of anastomotic stricture. The purpose of this study is to determine the clinical~     value of this kind of operation type, and analyzes the clinicopathological factors causing~     the postoperative complications.~   "
185300|NCT01139216|"~     The purpose of this study is to assess the dose-related effects of TU-100, a botanical agent~     that modulates gastrointestinal nerves, on rectal compliance, rectal sensation thresholds and~     small bowel and colonic transit in female patients with functional constipation as compared~     to placebo.~   "
185301|NCT01139203|"~     Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and~     adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune~     globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver~     transplantation patients with Hepatitis B Virus (HBV) related diseases.~   "
185302|NCT01139190|"~     The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of~     PL3100 versus Naproxen in normal healthy volunteers.~   "
185303|NCT01139177|"~     The primary objective of this study is to evaluate the safety and performance of the SAMBA~     Stent and Delivery System in the treatment of femoropopliteal lesions.~   "
185304|NCT01139164|"~     This is study is for patients that have been diagnosed with high-risk hematological~     malignancies. The main purpose of this study is to confirm previously published results of~     stem cell transplantation with reduced intensity pre-transplant conditioning. Patients will~     be assigned to 1 of 3 regimens depending on the patient's diagnosis. Participants will be~     followed by the transplant team for the remainder of the patient's life. Patient's will visit~     MUSC daily, then visits will be reduced to frequent visits for up to 6 months. After 6~     months, the visits will be reduced more depending on the patient's condition.~   "
185305|NCT01139151|"~     The goal of this clinical research study is to find the highest tolerable dose of~     4'-thio-araC (thiarabine) that can be given to patients with advanced blood cancer. The~     safety of this drug will also be studied and 2 different dose schedules will be tested.~   "
185306|NCT01139138|"~     This study will assess the safety of panitumumab, irinotecan and everolimus when given in~     combination to treat advanced colorectal cancer~   "
185307|NCT01139125|"~     The purpose of this study is to determine the tolerability of the medication cysteamine~     bitartrate on schizophrenia patients and to evaluate the effect of the medication on the~     symptoms of schizophrenia.~   "
185308|NCT01139112|"~     This is a retrospective descriptive study on the clinical and microbiological features of~     Klebsiella Pneumoniae Necrotizing Fasciitis.~   "
185309|NCT01139099|"~     Although the patients with schizophrenia can be treated with new generation of antipsychotics~     medication, additional approaches are necessary to improve schizophrenics' cognitive~     functions, interpersonal relationships as well as social adjustment. When some of patients~     return to community, they expose to practical pressure that contribute to worsen and relapse~     of disease. That further damages patient's cognitive functions. Integrated Psychological~     Therapy(IPT) on treating schizophrenia has dramatic improvement in recent years; it has~     formed structured treatment gradually on relieving illusion, hallucination as well as~     negative symptoms. This study aims at conducting 12-week structured IPT group therapy. The~     intended subjects are patients, met with DSM-Ⅳ-TR diagnosis of schizophrenia, from community,~     outpatient and inpatient service. The overall treatments are designed to provide 1-2 hours~     weekly group therapy which focuses on relieving illusions, hallucination, and negative~     symptoms. Patients' cognitive functions, ability of emotional adjustment and interpersonal~     relationship would be evaluated in pre-test and post-test to indicate whether the significant~     difference exists. There is a controlled group, in which patients who still receive treatment~     as usual (TAU). The study also compares the evaluation results between IPT group and TAU~     group, hoping to develop the therapeutic framework for Taiwan people with schizophrenia.~   "
185310|NCT01139086|"~     Shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart~     failure (CHF). Recent studies suggested that peripheral impairment was the major cause of~     clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular~     smooth muscle dysfunction. It results in increased peripheral resistance that may influence~     limb blood flow, muscle fitness and activities of daily.The purposes of this study are~        1. to compare muscular strength, endurance, and perfusion of quadriceps between CHF~          patients and healthy controls by isokinetic test and near-infrared spectroscopy (NIRS)~          and difference in activities of daily living~        2. to compare endothelium function between CHF patients and healthy control subjects~        3. the relationship between endothelium function, muscular strength, endurance, perfusion,~          and metabolism of quadriceps.~   "
185312|NCT01139060|"~     The purpose is to test the effectiveness of an organized care program for chronic or~     recurrent depression. Using a two-arm design, the investigators will randomly assign 300~     participants with chronic or recurrent depression to one of two conditions: continued usual~     care (UC); or an 18-month organized treatment program focused on outreach and engagement,~     including a weekly group self-management training program, monthly visits with a~     psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer~     support specialist. All intervention components are intended as adjuncts to any existing~     depression treatment (usually antidepressant medication) provided by participants' regular~     providers.~   "
185313|NCT01139047|"~     The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in~     subjects with healthy skin applied according to product labeling for three weeks.~   "
185314|NCT01139034|"~     The purpose of this study is to investigate the effects of the self-designed surface~     functional electrical stimulator on shoulder joint subluxation for stroke patients~   "
185315|NCT01139021|"~     One year antibody persistence after the fourth dose boost or two catch-up doses administered~     starting from 12 months of age and to evaluate the response to a a third dose boost or two~     catch-up dose starting at 24 months of age.~   "
185316|NCT01139008|"~     The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1%~     to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product~     labeling for three weeks.~   "
185317|NCT01138995|"~     The objective of this study is to determine the effectiveness of the NESS L300 (L300) in~     improving gait parameters, function, and quality of life among stroke subjects (greater than~     or equal to 3 months post stroke)with drop foot.~   "
185318|NCT01138982|"~     This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary~     preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and~     exclusion of study participants are elaborated in collaboration with the providing NGO, and~     the program is given as customary.~   "
185319|NCT01138969|"~     Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.~   "
185320|NCT01138956|"~     This study is designed to evaluate the immune and therapeutic responses of visceral~     leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent~     antimony.~   "
185321|NCT01138943|"~     The aim of the present study was to compare antiplaque effectiveness of two commercial~     mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine~     non-alcohol base with 0.1% of Formaldehyde (CLX-F).~   "
185322|NCT01138930|"~     Berberine has showed effective in lowering blood sugar levels in db/db mice and~     anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal~     features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this~     study is to examine the effect of Berberine metabolic and hormonal parameters and insulin~     resistance in obese patients with PCOS.~   "
185323|NCT01138904|"~     FOLFOX* followed by FOLFIRI** or reverse sequence treatment regimen have been used as a~     standard treatment modality in metastatic colorectal cancer.Oxaliplatin and Irinotecan were~     used for advanced gastric cancer also. The investigators study was designed to evaluate the~     safety and efficacy of FOLFOX followed by FOLFIRI or reverse sequence treatment regimen as a~     first-line and second line therapy for patients with relapsed or metastatic gastric cancer~     similar with colorectal cancer.~      *FOLFOX: oxaliplatin followed by leucovorin before bolus 5-FU followed by continuous infusion~     5-FU~      **FOLFIRI: irinotecan followed by leucovorin before bolus 5-FU followed by continuous~     infusion 5-FU~   "
185324|NCT01138891|"~     Objective. Capsular contracture is a frequent complication after breast implantation with~     unclear etiology.~      Summary Background Data: Microorganisms may trigger chronic periimplant inflammation with~     subsequent capsular fibrosis.~      Study Hypothesis: The investigators hypothesize that with sonication adherent microorganisms~     can be detected on removed implants .~      Methods: In a prospective multicentre study all breast implants explanted are collected to be~     analyzed by sonication. The resulting culture results are correlated with patient, surgical~     and implant characteristics.~   "
185325|NCT01138878|"~     Surveillance data suggests that approximately one third of the 82 000 HIV infected adults in~     the UK remain undiagnosed - that is, they are living with the infection but do not know this.~     The majority of HIV testing in the UK to date has taken place in sexual health clinics and in~     antenatal care. Published National guidelines advocate routine HIV testing of 16-65 year olds~     in more general healthcare settings in parts of the country with relatively high rates of HIV~     (more than 2 per thousand individuals diagnosed locally). The HINTS Study investigates the~     utility, feasibility and acceptability, to patients and staff, of offering routine HIV~     testing in four general medical settings, all set in areas of high HIV prevalence. The~     settings comprise: Primary Care, Outpatients, an Acute Care Unit and an Emergency Department.~   "
185326|NCT01138865|"~     CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep~     fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of~     cardiovascular, mortality risks in the same patients.~   "
185327|NCT01138852|"~     The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of~     cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been~     assessed.~      Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g~     of ampicillin-sulbactam or 1.5g of cefuroxime intravenously, after umbilical cord clamping.~     An evaluation for development of postoperative infections and risk factor analysis was~     performed.~   "
185328|NCT01138839|"~     The purpose of this study is to determine the efficacy of dexamethasone for treatment of~     HELLP I (hemolysis, elevated liver enzymes and low platelet count) syndrome.~   "
185329|NCT01138826|"~     This study is being performed to determine the bioavailability, or extent of absorption into~     the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to~     the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.~   "
185368|NCT01138319|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in patients with acute myeloid leukemia.~   "
185330|NCT01138813|"~     This study will evaluate the test-retest repeatability of lactate and other metabolites~     measured by single voxel magnetic resonance spectroscopy (MRS) and multi-voxel magnetic~     resonance spectroscopic imaging experiments (MRSI) in tumor tissue in patients~     radiographically diagnosed with glioma.~      These measurements will test whether the concentration of lactate in tumor will be higher~     than the concentration of lactate in normal tissue of the same patient.~   "
185331|NCT01138800|"~     Interstitial cystitis (IC) is a chronic disorder with significant symptoms of urinary~     urgency, frequency and pelvic pain. IC is more prevalent in women than men. Similar to other~     chronic pain syndromes such such as irritable bowel syndrome (IBS) and fibromyalgia, the~     cause of IC is not fully understood. Two subtypes of IC have been identified: classic IC~     (ulcerative IC) where visible ulcers exist in the bladder and non ulcerative IC, where~     bladder abnormalities are not apparent but significant bladder-related symptoms exist. We~     hypothesize that ulcerative IC is a disease of the bladder whereas non ulcerative IC is a~     more generalized and centrally-mediated chronic pain syndrome similar to IBS and~     fibromyalgia. To test this hypothesis, we will compare the presence of pain~     conditions/symptoms in ulcerative vs. non ulcerative IC women vs. community dwelling women~     (controls) without an IC diagnosis.~   "
185332|NCT01138787|"~     Rationale: Consuming Plant Sterols (PS) fortified foods is widely accepted as easy to apply,~     life-style change to combat modestly elevated plasma cholesterol concentrations. PS are~     typically formulated as PS fatty acid ester (PSE) from margarines. In this study, PS will be~     formulated in a new innovative type spread. To confirm that the new spread results in a~     comparable cholesterol absorption inhibition as the reference product a dual isotope~     cholesterol study is planned, prior to any larger efficacy study.~      Primary objective: Cholesterol absorption inhibition (%) calculated from plasma concentration~     vs. time curves from labeled cholesterol, for the PS or PSE containing products, compared to~     a control product without PS or PSE.~      Secondary objectives: PK parameters for cholesterol as derived from the plasma concentration~     vs. time curves.~      Study design: Acute, single dose, double-blind, randomized, cross-over. Study population: 18~     healthy, non-obese men (BMI 20-27 kg∙m-2, age range 20 - 65 yr) Test products: PS (2250 mg)~     formulated in innovatively processed spread (30 g); PSE (2250 mg PS) reference product (30~     g); Control product without PS or PSE (30 g) Intervention: Three study periods during which a~     single dose of either Test, Reference or Control (regular light spread) spreads will be~     consumed together with standard breakfast. At each study period, 50 mg of D7-cholesterol is~     added to the meal and 30 mg of 13C-cholesterol is injected to measure cholesterol absorption.~     Before and four times after consumption of each spread, blood samples will be taken at 24 h~     intervals up to 7 days.~      Key parameters: Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS.~     Fractional absorption is determined by the ratio of the two isotopes in plasma cholesterol~     after 7 days.~   "
185333|NCT01138774|"~     The aim of the study is to analyze the effects of Lipoic acid and/or EPA supplementation on~     weight loss, lipid profile, insulin resistance, oxidative and inflammation parameters,~     metabolomic profile as well as on adipose tissue gene profile in healthy overweight/obese~     subjects following an energy-restricted diet.~   "
185334|NCT01138761|"~     The purpose of this study is to determine the effectiveness of additional nursing instruction~     for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University~     of Missouri Dermatology clinic.~   "
185335|NCT01138748|"~     Surgical resection with mediastinal lymph node sampling is currently the therapy of choice~     for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or~     unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This~     has shown to result in a long term local disease control rate and a high cancer specific~     survival.~      The current trial addresses the issue if progression free survival (PFS) in patients treated~     with radiotherapy can be predicted by a multi-variate model derived from a composite of~     bio-imaging and biomarkers~   "
185336|NCT01138735|"~     The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and~     benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to~     11 years of age with acne vulgaris.~   "
185337|NCT01138722|"~     Surgical resection with mediastinal lymph node sampling is currently the therapy of choice~     for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or~     unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This~     has shown to result in a long term local disease control rate and a high cancer specific~     survival.~      The current trial addresses the relationship between blood and tissue biomarkers, bio-imaging~     and pathology in patients with early stage NSCLC treated with hypofractionated radiation~     therapy and surgery.~   "
185338|NCT01138709|"~     The primary objective of this phase II clinical trial is to assess the safety of the Vitala™~     device during 12 hours of daily wear with convex products.~   "
185339|NCT01138696|"~     About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the~     repairing and replacement of injuries of the anterior cruciate ligament. After less than 10~     years it appeared that a relatively important number of patients showed complications on the~     basis of synovitis. The situation of another group of patients on the other hand evolved~     favourably without complications. The study to focuses on this group of patients and attempts~     to determine how the replacement without problems ab initio, evolved in the time.~      It concerns a group of 57 patients who received an implantation in the UZ Ghent between~     November 85 and October 87 with the Stryker Dacron ligament and a group of 33 patients who~     received the Trevira ligament in the ASZ Aalst. The clinical result will be stipulated by~     means of standardized questionnaires and a clinical examination. The radiological result will~     be determined by the degree of integrity of the ligament that was implanted at the time. In~     this way the study could give an idea about the degree in which the technical success of the~     intervention correlates with the clinical success 20 years later.~   "
185340|NCT01138683|"~     The CRUF trial is a prospective randomized monocentric trial comparing different impact of~     diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic~     filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).~   "
185341|NCT01138670|"~     This study examines possible risk factors with regard to complications following pacemaker or~     implantable defibrillator cardioverter (ICD) implantation.~   "
185343|NCT01138644|"~     It is our hypotheses that 1) readily available Emergency Department data can be utilized in~     an Atrial Fibrillation clinical prediction rule to identify those patients at low or high~     risk for adverse outcomes; 2) Assigned risk can be utilized to drive physician~     decision-making by identifying patients who do not require hospital admission (low risk) and~     patients needing hospitalization (high risk); and 3) a facile version of the AFPR will be~     easily incorporated into standard Emergency Department patient management systems and assist~     physicians with risk stratification of patients presenting with Atrial Fibrillation.~   "
185344|NCT01138631|"~     In order to improve success rate by assisted reproductive techniques new techniques are being~     developed for selection of the embryo with best chance of implantation, establishement of~     pregnancy and subsequent delivery.The present study is based upon the hypothesis that~     time-lapse (frequent imaging) may give information about important steps in embryonic~     development, which could help to optimize selection of embryo(s) for treatment in IVF. The~     present study evaluates the outcome of conventional embryo culture with culture in a~     specially developed incubator equipped with a time-lapse system (Embryoscope).~      Embryos from 50 IVF cycles (400 embryos) will be randomised to either conventional incubation~     or to culture in the Embryoscope. Embryos will be cultured for five days to the blastocyst~     stage. The primary endpoint is fraction of embryos developed to the four cell stage.~   "
185345|NCT01138618|"~     Clozapine remain the drug of choice for treatment resistant schizophrenia and up to 60% of~     patients not responding to other antipsychotics will respond to clozapine. However, the use~     of clozapine is restricted due to the risk of agranulocytosis and consequently the need for~     mandatory hematological monitoring. CHEMPAQ XBC is a point-of-care device that can be used in~     patients home and analyze WBC and granulocytes by a single capillary blood drop. This study~     aims to investigate whether this new procedure increases the acceptability of clozapine~   "
185346|NCT01138605|"~     The primary objective of this study is to continue to provide Darunavir (DRV) to pediatric~     patients who previously received DRV in any of three pediatric clinical studies sponsored by~     Tibotec Pharmaceuticals and continue to benefit from using it, in countries where DRV is not~     yet commercially available for the pediatric patient, is not reimbursed or cannot be accessed~     through another source (like access program or government program).~   "
185347|NCT01138592|"~     Primary Objective: Evaluation of the utility of real-time, scope-to-scope communication~     between commercially-available 3M Littmann Electronic Model 3200 Electronic stethoscopes over~     a dedicated intranet system for the assessment of patients at remote (satellite) clinic~     locations by centrally-located (hub) medical providers.~      Secondary Objective: Comparison of the accuracy of patient assessment between the remotely~     located, mid-level presenter with the centrally-located physician or nurse practitioner~     provider.~   "
185348|NCT01138579|"~     This study is an investigator driven, open-label, non-randomized, uncontrolled, dose~     escalating Phase I/II study evaluating the safety and preliminary efficacy of the~     trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI)~     for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade~     non-Hodgkin´s lymphoma after allogeneic transplantation~   "
185349|NCT01138566|"~     The purposes of this study are:~        1. To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or AmpC among~          Enterobacteriaceae which cause community-onset urinary tract infections (UTIs)~        2. To collect the background, risk factors and clinical outcome of patients with~          community-acquired uropathogenic condition related to Enterobacteriaceae (both ESBL,~          AmpC- and non ESBL and/or AmpC producing) after receive different antibiotic regimens.~        3. To develop a scoring system to early identify patients at risk of being infected with~          ESBL- and/or AmpC-producing Enterobacteriaceae by comparing the risk factors for~          community-onset UTIs caused by ESBL- and/or AmpC-positive against non ESBL -and/or AmpC~          Enterobacteriaceae~        4. To demonstrate the efficacy and safety of ertapenem for the empiric treatment of~          community-onset UTIs in patients at risk for ESBL- and/or AmpC-producing organism.~      The study hypothesis (i) Patients infected with community-acquired uropathogenic ESBL- and/or~     AmpC-producing Enterobacteriaceae who receive regimens other than carbapenems have a worse~     outcome.~      (ii) There are certain risk factors predicting the acquisition of community-onset UTIs caused~     by ESBL- and/or AmpC-producing Enterobacteriaceae.~      (iii) The use of ertapenem is an effective and safe empirical therapy compared with other~     agents for community-onset UTIs caused by ESBL- and/or AmpC-producing Enterobacteriaceae.~   "
185350|NCT01138553|"~     The primary objective of this study is to identify the group of women with early stage breast~     cancer most likely to benefit from treatment with the selective progesterone receptor~     modulator (SPRM) mifepristone. This will be done by treating women briefly prior to planned~     surgery and examining the decrease in growth rate (measured by Ki-67 immunohistochemistry) in~     tumor samples taken before and after exposure to mifepristone.~   "
185351|NCT01138540|"~     This study is planned to compare, in patients sedated, intubated and mechanically ventilated,~     the efficacy and safety of the Lateral Trendelenburg position in comparison to the~     Semirecumbent Position to prevent incidence of ventilator-associated pneumonia (VAP).~   "
185352|NCT01138527|"~     The primary objective of this prospective multi-centre study is to prove the diagnostic~     accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted~     MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate~     tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount~     sections of the resected prostate by a genitourinary histopathologist.~   "
185353|NCT01138514|"~     The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel~     Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical~     Gel (Clindamycin- Benzoyl Peroxide Gel).~   "
185354|NCT01138501|"~     This trial is conducted in Asia, Europe, and North and South America. The aim of this~     clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant~     factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.~   "
185355|NCT01138488|"~     This trial was conducted in Europe. The aim of this study was to investigate the total~     exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult~     subjects with type 1 diabetes.~   "
185356|NCT01138475|"~     Evaluate the efficacy of paricalcitol, cholecalciferol, and placebo in the reduction of~     parathyroid hormone in patients after Roux-en-Y gastric bypass surgery (RYGB). Assess~     changes, if any, in measures of self-assessed well-being attributable to paricalcitol after~     RYGB. Evaluate the rates of hypercalcemia, kidney stones, gastrointestinal side effects, and~     other organ system adverse effects of paricalcitol, cholecalciferol, and placebo in patients~     after RYGB~   "
185357|NCT01138462|"~     The purpose of this study is to determine the better approach between the currently procedure~     (i.e. standards precautions) and a reinforced strategy to control MRSA transmission in the~     institutionalized population of nursing homes in Canton of Vaud, Switzerland.~   "
185358|NCT01138449|"~     The study is a large randomized controlled trial to assess the efficacy and safety of~     neonatal vitamin A supplementation administered to neonates once orally either on the day of~     birth or in the next 2 days in improving infant survival in the first 6 months of life.~   "
185359|NCT01138436|"~     This is a Phase II, randomized, controlled, two-center pilot study designed to assess the~     safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry~     criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either~     MEBO or SOC (7 subjects per treatment arm).~   "
185360|NCT01138423|"~     High blood pressure (hypertension) is an important cause of myocardial infarction and stroke.~     High blood pressure often occurs in people who are overweight. These people frequently also~     have abnormal fat and sugar metabolism. The combination of these problems is called the~     'metabolic syndrome'.~      People with hypertension and obesity currently receive the same drug therapy as people with~     hypertension, but without obesity. Different classes of drugs are thought to be equally~     effective in lowering blood pressure.~      Next to lowering blood pressure, hypertension treatment can have additional effects, like~     changes in blood vessel function (the ability to dilate and constrict) or changes is the~     metabolism of sugar and fat. Particularly in patients with the metabolic syndrome, these~     additional effects are thought to be of great importance, because they can influence the risk~     for cardiovascular diseases.~      The blood pressure lowering mechanism differs between classes of blood pressure lowering~     medication. The purpose of this study is to compare the effects of three types of blood~     pressure lowering medication belonging to different classes. The main outcomes of interest~     will be blood vessel function (the ability to dilate and constrict) and blood pressure.~     Moreover, the effect of treatment on additional outcomes, like metabolism of sugar and fat,~     will be studied.~   "
185361|NCT01138410|"~     The study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma.~     SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human~     cells. The antibody modifications are designed to stimulate the patient's immune T cells to~     have a strong and specific reaction against melanoma cells which should then be eliminated.~     SCIB1 is injected into muscle using a device which simultaneously delivers an electrical~     impulse to enhance the transfer of SCIB1 into muscle cells. The trial will assess the safety~     and tolerability of SCIB1, the safety and performance of the injection device and the~     immunological effects of SCIB1. This is the first study of SCIB1 in humans and the trial has~     two parts, in the first part the dose will be escalated to determine a safe and tolerable~     level up to a maximum of 8 mg per dose. In the second part patients will receive the dose~     determined in the first part. Patients will have stage III or IV melanoma, be HLA type A2 and~     have a life expectancy of at least three months. All patients will receive 5 injections of~     SCIB1 over 5.5 months. At the discretion of the investigator, patients may continue to~     receive SCIB1 at 3-6 month intervals for 5 years. The study will be conducted at major cancer~     centres in the UK only and is expected to last for seven years. Patients will be followed up~     for five years after they have completed the trial.~   "
185362|NCT01138397|"~     The aim of this study is to evaluate the new formulation of the influenza vaccine for the~     2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the~     corresponding population and to check its compliance with the Committee for Proprietary~     Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96~      Objectives:~        -  To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the~          intradermal (ID) influenza vaccine NH 2010-2011 formulation with the requirements of the~          CPMP NfG CPMP/BWP/214/96.~        -  To describe the safety of the corresponding strength of the ID influenza vaccine, NH~          2010-2011 formulation.~   "
185363|NCT01138384|"~     This research is being done because it is not yet known what dose of foretinib in combination~     with lapatinib can be given safely to patients with breast cancer, nor what type and severity~     of side effects will result from the combination of the two treatments. This research is also~     being done because it is not clear if the addition of the new drug foretinib to treatment~     with lapatinib can offer better results and longer survival than treatment with lapatinib~     alone.~   "
185364|NCT01138371|"~     The primary objective of this study is to measure how LDL apheresis affects levels of~     inflammatory and cholesterol markers in human beings. The investigators will address this~     question by drawing pre- and post-LDL apheresis blood from patients who are undergoing this~     procedure. A secondary objective of this study is to learn how specific inflammatory markers~     behave in our blood in terms of time to rebound back to normal levels. The investigators will~     address this question by drawing post-LDL apheresis blood at predetermined time intervals.~   "
185365|NCT01138358|"~     RATIONALE: Gathering information about experiences of episodic breathlessness in patients~     with advanced disease may help doctors learn more about the disease.~      PURPOSE: This clinical trial is studying experiences of episodic breathlessness in patients~     with lung cancer or other advanced disease.~   "
185366|NCT01138345|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     understand how well patients respond to treatment.~      PURPOSE: This research study is studying biomarkers in blood samples from older women with~     stage I, stage II, or stage III breast cancer who have finished primary therapy or breast~     cancer survivors.~   "
185367|NCT01138332|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from young patients~     with acute myeloid leukemia.~   "
185370|NCT01138293|"~     Aims: During the last decades overweight/obesity has increased markedly. They are associated~     with a high risk for diabetes and death. Effective intervention is mandatory. Following~     participation in treatment programmes children/adolescents often fail to reach sufficient~     long-term weight reduction. The present trial aims to integrate telemedical support in~     therapy to improve long term outcome.~      Methods: All children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6~     years, body mass index [BMI] 31.2±5.4kg/m², body mass index standard deviation score~     [BMI-SDS] 2.41±0.6) admitted to our hospital 04-03/2009. To asses physical activity and~     eating habits electronic health technology was used (Fraunhofer-Institute). The system~     consists in a motion sensor integrated in a mobile phone(DiaTrace). The system analyses kind,~     intensity and duration of physical activity and eating habits.~   "
185371|NCT01138280|"~     Hemodialysis (HD) may lead to increase inflammatory response through a number of mechanisms.~     HD-related inflammation is mainly due to underlying kidney disease, coexisting comorbidities,~     uremia per se, dialyzer membrane biocompatibility and contaminated dialysis fluid.~     Accordingly, HD patients are chronically exposed to microinflammation as a result of~     blood-membrane interaction and dialysis fluid contamination. Among these factors, biofilm~     formation and contaminated dialysis fluid are closely related to enhanced immune activation~     in HD patients. Furthermore, only dialysis fluid quality is controllable and preventable.~     Therefore, to reduce the cardiovascular (CV) events and improve the outcome, it prompts us to~     conduct a prospective randomized controlled study to explore whether heat disinfection link~     in HD water treatment system can effectively prevent biofilm formation, to ensure the~     dialysis fluid purity, and subsequently to improve the patient outcome, in terms of CV events~     and mortality.~   "
185372|NCT01138267|"~     Objectives:~        -  To evaluate the impact of genetic polymorphism on ARV drug levels~        -  To evaluate the effect of genetic polymorphism/drug levels on long term immunologic and~          virologic response~        -  To correlate the genetic polymorphism/drug levels on antiretroviral toxicities~      The long-term objective of this research plan is to characterize impact of pharmacogenomics~     to HIV drug concentration, toxicities, and response to antiretroviral therapy among~     HIV-infected adults. A comprehensive understanding of the impact of pharmacogenomics to HIV~     infection and HIV medication will lead to the development of appropriate intervention such as~     dose reduction strategies in patients with particular gene(s) correlated with higher drug~     levels. The dose reduction strategy will decrease long term drug toxicity and cost saving for~     Thais and Asian Ethnicities.~   "
185373|NCT01138254|"~     Vascular access complications are the leading cause of morbidity in hemodialysis (HD)~     patients, and are responsible for a significant percentage of hospitalization, with annual~     costs approaching one billion dollars in the United States. Thrombosis is the most common~     cause of vascular access failure, and usually develops from stenotic lesions in the venous~     outflow tract. It has been reported that far infrared (FIR) therapy can improve access flow~     and unassisted patency of AV fistula, however, the effect of FIR on cardiac function is~     unknown.~      The aims of this study are to evaluate (1) the change of access flow of AV fistula and the~     effect of AV fistula on echocardiographic parameters and (2) the effect of FIR on access flow~     of AVF and echocardiographic parameters and the serum levels of endothelial markers in~     patients with end stage renal disease (ESRD) during the first 6 months after the creation of~     AV fistula.~   "
185374|NCT01138241|"~     To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients~   "
185375|NCT01138228|"~     VueTek has developed a head mounted device that will improve the viewing of superficial,~     subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue.~     Video of the vasculature is displayed to the user in a portable headset. The headset and~     display combination facilitates both visualization in the display and an open field of view~     directly to the subject's anatomy and practitioner's surroundings. The goal is to provide a~     non-diagnostic, enhanced visual aide that is used alongside standard visual and tactile~     methodology. The primary and secondary objectives of this validation are as follows:~        1. Primary Objective:~           To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous~          vascular structures, when compared to the naked eye.~        2. Secondary Objective:~      To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular~     structures over the naked eye.~      Validation Ancillary Endpoints~      1. To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular~     access methods, and provides flexibility, fit and balance during use.~   "
185376|NCT01138215|"~     To study about the immunogenicity, safety and efficacy of varicella-zoster virus vaccine in~     HIV-infected children.~   "
185377|NCT01138202|"~     To assess safety, efficacy and impact of Lopinavir/ritonavir 400/100mg bid or~     Lopinavir/ritonavir 600/150mg bid in combination with rifampicin-containing anti-TB therapy.~   "
185378|NCT01138189|"~     The purpose of the study is to compare the results of LASIK surgery when using~     wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser~     treatment in patients with nearsightedness with and without astigmatism~   "
185379|NCT01138176|"~     A prospective randomized control trial to examine safety and effectiveness of whole body~     cooling to a rectal temperature of 33.5 C using phase changing material in neonatal~     encephalopathy. Effectiveness will be defined by examining the stability of rectal~     temperature during cooling. Monitoring of vital signs, infection screen, blood counts,~     coagulation screen, liver and renal function tests, cranial US and MR imaging will be~     performed on recruited infants to evaluate safety of cooling. EEG will be performed on day 4~     and hearing evaluation at discharge. Neurodevelopmental evaluation will be performed at 1~     year of age.~   "
185380|NCT01138163|"~     The primary purpose of this research study is to see whether adding bavituximab (an~     investigational drug) to the standard chemotherapy drug docetaxel, will improve the results~     of the treatment for non-small-cell lung cancer.~   "
185381|NCT01138150|"~     The purpose of this study is to evaluate blood levels of several proteins that may be altered~     in the inflammation associated with migraine headaches. These blood levels will be evaluated~     in individuals during an acute migraine attack and compared to their levels when pain free.~     The investigators study hypothesis is that the pro inflammatory proteins in the blood will be~     greater than the levels of these proteins when evaluated during a pain free period.~   "
185382|NCT01138137|"~     RATIONAL FOR STUDYING IV NAC AS POTENTIAL CHEMOPROTECTANT:~      Cisplatin has shown efficacy in the treatment of subjects with epithelial ovarian cancer.~     Systemic toxicities associated with cisplatin include nephro, oto, and nerve toxicities. It~     may be possible to reduce the toxicities of cisplatin by administering it in conjunction with~     IV NAC. NAC may reduce cisplatin related nephro, oto, and nerve toxicities without~     compromising the effectiveness of the chemotherapy against the ovarian cancer cells. It is~     possible that this combination of drugs may in the future allow ovarian cancer patients to~     receive the full series of IP cisplatin-paclitaxel chemotherapy, with fewer side effects and~     improved survival.~      It is hypothesized that the proposed treatment of stage III or IV epithelial ovarian cancer~     with IP cisplatin and IV/IP paclitaxel in conjunction with IV NAC will limit the~     neurotoxicity, nephrotoxicity and ototoxicity that is associated with cisplatin~     administration.~   "
185383|NCT01138124|"~     High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there~     has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by~     spontaneous reports in the Adverse Events Reporting System or in the published literature. In~     a published case-control screening study of the association of gabapentin with 55 cancers,~     the only cancer that met the screening criteria for possibly increased cancer risk with~     gabapentin exposure was renal (including renal pelvis) cancer. This association was judged to~     be likely due to or substantially accentuated by confounding by cigarette smoking,~     hypertension, and lifestyle (Cancer Causes Control 2009;20:1821-1835).~      The primary objective of this study is to determine whether exposure to gabapentin is~     associated with an increased risk of developing pancreatic cancer or renal cancer in the~     United Kingdom (UK) General Practice Research Database (GPRD). Almost all members of the UK~     population are registered with a General Practice, which centralizes the medical information~     not only from the general practitioners themselves but also from specialist referrals and~     hospital attendances. Over 487 General Practices contribute data to the GPRD.~      The study cohort from which cases and controls are drawn is all subjects in the GPRD~     1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins~     Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of~     registration if later than Jan 1, 1993. Patients with a first diagnosis of the respective~     cancer 1995-2008 are risk set matched with up to 10 controls within the same General Practice~     for age at cohort entry (within two years), sex, and year of entry into the study cohort~     (within one year). For cases, the index date is the date of first diagnosis of the respective~     cancer. The index date for controls is set as the date at which the follow-up time from~     cohort entry is the same as the case. The index date is chosen so as to give the control~     equal follow-up time to that of the case for ascertainment of use of gabapentin. Cases and~     controls will be required to have at least 2 years of follow-up in the study cohort before~     their index date. Data on gabapentin prescriptions are obtained for cases and controls from~     study cohort entry to the index date.~      Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from~     conditional logistic regression models, with additional analyses evaluating for latency and~     dose-response. For pancreatic cancer, covariates are smoking, body mass index, diabetes,~     epilepsy, neuropathic pain, and chronic pancreatitis. For renal cancer, covariates are~     smoking, body mass index, diabetes, hypertension, diuretic use, epilepsy, and neuropathic~     pain.~   "
185384|NCT01138111|"~     The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission~     tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI)~     progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.~   "
185385|NCT01138098|"~     This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after~     vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune~     response to the challenge dose of Engerix™-B.~   "
185386|NCT01138085|"~     This study is a Phase 1 dose-escalation open-label study to determine the recommended Phase~     II dose (RP2D) and regimen for the combination of the orally administered MEK inhibitor~     GSK1120212 and the orally administered AKT kinase inhibitor GSK2141795. The study consists of~     two parts. Part 1A will identify the maximum tolerated dose (MTD) using a Zone-Based,~     modified 3 plus 3 dose escalation procedure. The starting dose (Zone 1, Cohort 1) will be~     0.5mg GSK1120212 combined with 25mg GSK2141795. Dose escalation will continue based on~     predefined parameters until a MTD is established. The initial regimen for dose escalation in~     Part 1A will be continuous oral daily dosing. Once the continuous daily dosing MTD or RP2D~     has been established in Part 1A, Part 1B will explore alternate dosing schedule(s) in which~     the dosing schedule may be adjusted for either GSK1120212 or GSK2141795. Dose escalation will~     proceed using a 3 plus 3 dose escalation procedure until an MTD or RP2D of that alternate~     schedule is defined. Part 2 will explore further in specific tumor types the safety,~     tolerability, clinical activity, pharmacokinetic (PK) and pharmacodynamic (PD) properties of~     the combination of GSK1120212 and GSK2141795 at the recommended dose(s) and regimen(s)~     identified in Part 1.~   "
185387|NCT01138072|"~     This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the~     effect of repeated doses of GSK2248761 on the pharmacokinetics of simvastatin, atorvastatin,~     and rosuvastatin in healthy adult subjects. In this study, approximately 14 subjects will~     receive single doses of simvastatin, atorvastatin, and rosuvastatin on two occasions, once~     alone and once following administration of repeated doses of GSK2248761. Safety evaluations~     and serial PK samples will be collected during each treatment period. A follow-up visit will~     occur 7-14 days after the last dose of study drug.~   "
185388|NCT01138059|"~     This study will test the hypothesis whether patients with unclear-onset stroke (UnCLOS)~     treated with thrombolysis could achieve a prespecified rate of good clinical outcome. The~     secondary hypothesis is that the efficacy outcomes in UnCLOS group would be superior to those~     in historical UnCLOS group from prospective stroke registries.~   "
185389|NCT01138046|"~     This is an open-label, non-randomized, multi-center study of lapatinib plus paclitaxel to~     evaluate safety, tolerability and efficacy in Japanese patients with ErbB2 over expressing~     advanced or metastatic breast cancer. Lapatinib 1500mg/day will be administered in~     combination with paclitaxel 80mg/m2/week. Lapatinib and paclitaxel will be administered until~     disease progression or withdrawal from the study due to unacceptable toxicity.~      The study will proceed in two phases. The first phase (Phase I part) will lead to evaluate~     safety and tolerability of lapatinib taken together with paclitaxel in the first 6 subjects.~     Pharmacokinetic profile also will be evaluated as the secondary objects.~      Then the study will move to the next treatment phase (Phase II part) to evaluate further~     safety and clinical activity, if no major safety concerns are raised during Phase I part. The~     primary objective of the study is to evaluate overall survival (OS), and the secondary~     objectives are Objective tumour response rate (ORR), Duration of response, Time to response,~     Clinical benefit and Progression-free survival (PFS) in 12 subjects.~   "
185427|NCT01137552|"~     This is a first in human, open-label, sequential dose escalation and expansion study of AMG~     780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is~     aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG~     780. The dose expansion will consist of up to 20 subjects and the dose level of AMG 780 will~     be dependent upon emerging safety and PK data from the dose escalation part of the study.~   "
185390|NCT01138033|"~     This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will~     identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following~     identification of the MTD, enrollment into Parts 2, 3, 4 and 5 may be concurrent. Part 2 will~     explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in~     subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will~     characterize the range of biologically effective doses by assessing pharmacodynamic (PD)~     markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above~     the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further~     the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed~     glioblastoma multiforme (GBM). The primary objective of this study is to determine the~     safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the~     pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to~     explore the anti-tumor activity of GSK2256098, and to explore relationships between~     GSK2256098 PK, PD and clinical endpoints. Part 5 will investigate the time course, the extent~     of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for~     potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098~     at Day 15 and later time points. The primary objective of this study is to determine the~     safety, tolerability, and MTD of GSK2256098.~   "
185391|NCT01138020|"~     The purpose of this study is to investigate the efficacy of a structured rehabilitation~     program on cognitive function and quality of life in individuals with blast-induced traumatic~     brain injury (bTBI).~   "
185392|NCT01138007|"~     This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison~     study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to~     patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for~     8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total~     score, and to evaluate the safety based on adverse events, clinical laboratory tests and~     vital signs.~   "
185393|NCT01137994|"~     This is a Phase II, randomized, open-label, multi-center study evaluating the efficacy and~     safety of lapatinib in combination with chemotherapy versus trastuzumab in combination with~     chemotherapy in women with HER2-positive and p95HER2-positive metastatic breast cancer (MBC).~     Eligible subjects will have newly diagnosed metastatic breast cancer (Stage IV) either as a~     primary diagnosis or as a recurrence following treatment of curative intent; not have~     received systemic or local treatment for MBC and have breast cancer that is positive for HER2~     and p95HER2. The primary objective is to compare progression-free survival (PFS) of lapatinib~     plus chemotherapy versus trastuzumab plus chemotherapy as first-line treatment in subjects~     with MBC exhibiting concurrent HER2 overexpression (and/or gene amplification) and expression~     of carboxy-terminal fragments of HER2 (p95HER2). The secondary objectives are to evaluate~     overall survival, overall response rate, clinical benefit response rate and the safety as~     well as tolerability of lapatinib plus chemotherapy and trastuzumab plus chemotherapy.~   "
185394|NCT01137981|"~     The APR began as the 'Zidovudine in pregnancy Registry' in January 1989 and became the~     'Antiretroviral Pregnancy Registry' in January, 1993. The purpose of the APR is to detect any~     major teratogenic effects involving any of the Registry drugs when administered to pregnant~     HIV positive women. The Registry is intended to provide an early signal of teratogenicity~     associated with prenatal use of the antiretroviral drugs. The Registry collects data on~     prenatal exposures to antiretroviral drugs, potential confounding factors (such as maternal~     age, disease status during pregnancy), and information about the outcome of the pregnancy.~      The Registry is managed by INC Research. The scientific conduct and analysis of the Registry~     data are overseen by an independent Advisory Committee consisting of members from the Centers~     for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National~     Institutes of Health (NIH), and the academic sector. Registry data are obtained from~     participating providers who encompass physicians in private practice as well as hospitals and~     community clinics.~      The registry is co-sponsored and co-funded by 26 pharmaceutical companies that manufacture~     drugs used in ART.~      For an updated version of the registry, please see NCT00404989.~   "
185395|NCT01137968|"~     The purpose of this is to evaluate the efficacy and safety of imetelstat (GRN163L) as~     maintenance therapy for patients with advanced stage NSCLC who have not progressed after 4~     cycles of platinum based therapy.~      Participants will be randomized in a 2:1 ratio to imetelstat + standard of care versus~     standard of care alone. Participants who received bevacizumab with their induction~     chemotherapy will continue to receive bevacizumab on this study.~   "
185396|NCT01137955|"~     Celiac disease is a condition in which the small intestine is damaged by gluten, the storage~     protein of wheat and similar proteins in barley and rye. The disease can cause different~     symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of patients~     respond to a gluten-free diet. However some patients (5-30%) have persistent symptoms and are~     considered to be poor responders to the diet. Bacterial overgrowth in the small intestine~     accounts for some of the refractory patients.~      This study seeks to determine if antibiotic therapy with rifaximin relieves the symptoms of~     patients who are poorly responsive to a gluten-free diet and whether this impacts their~     breath test results.~   "
185397|NCT01137942|"~     The immune response to Helicobacter pylori (Hp) importantly determines the pathogenesis of~     infection as well as the success of antibiotic eradication of the bacteria. The investigators~     want to demonstrate the importance of cathepsin X (CTSX), a cysteine protease, for the Hp~     eradication success. The diversity of the innate immune response to H. pylori antigens~     leading to either successful eradication of the infection or maintenance of chronic~     inflammation is connected to CTSX. The aim of this study is to determine whether H. pylori~     suppresses the CTSX expression and cytokine secretion in macrophage cell line THP-1 in the~     individuals that are not capable of eradicating the infection, opposite to H pylori in~     patients with successful H pylori eradication . The investigators also investigate the~     possibility whether strain-dependent differences in H. pylori lipopolysaccharide (LPS)~     influence the CTSX expression and cytokine secretion.~   "
185509|NCT01136447|"~     The purpose of this study is to determine whether ultrasound guidance or nerve stimulation is~     the best option for placing continuous peripheral nerve block catheters for upper limb~     surgery.~   "
185398|NCT01137929|"~     No single host or pathogen trait identified by previous research can be correlated with all~     cases of childhood acute pyelonephritis or APN (i.e., kidney/upper urinary tract infections)~     and APN-associated renal scarring (the outcome with the highest morbidity), making it~     difficult for physicians to determine which patients will be affected. Our proposal is to~     comprehensively study the relationships between the clinical manifestations of urinary tract~     infections (UTIs), the host risk factors and immune response, and the microbial species that~     cause these conditions. The result of the study will be a clinical severity score to~     personalize diagnostic and treatment strategies for infants with UTI, with the goal of~     decreasing the morbidity of APN/renal scarring and improving patient outcomes.~   "
185399|NCT01137916|"~     The objective of the present study is to evaluate the activity and safety of imatinib in~     patients with aggressive fibromatosis who, after receiving the standard therapy, show an~     inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.~   "
185400|NCT01137903|"~     Hypothesis:Surgical treatment of osteomyelitis in diabetic foot is more effective that~     medical treatment through antibiotherapy and leads wound healing in ulcers complicated with~     bone infection.Material and Methods: Randomized clinical trials which include two groups of~     patients (n=88), one receives medical treatment through antibiotherapy during 90 days and the~     other group receive conservative surgical treatment and antibiotics during 7 days after~     surgery. It will be studied differences between both groups in healing time, recidives,~     present and relationship of adverse events and outflow of quality of life related health .~   "
185401|NCT01137890|"~     This is a residential pilot trial to evaluate the pharmacodynamic interaction between~     zonisamide and cocaine, with the goal of evaluating zonisamide's potential for the treatment~     of cocaine dependence.~   "
185402|NCT01137877|"~     The objective of this study is to evaluate the effect of two experimental milk-based infant~     formulas on the growth and gastrointestinal (GI) tolerance of term infants.~   "
185403|NCT01137864|"~     CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions~     ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve~     the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet~     fully estimated using a randomized trial to compare the quality of care of patients who will~     benefit of the intervention.~      OBJECTIVES: To show using a randomized trial that patients hospitalized in emergency wards~     with IDS advice will receive more appropriate antimicrobial therapy but less exposure to~     antibiotics, as compared to patients who will not receive IDS advice.~      METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of~     prescriptions in two groups of patients admitted in emergency wards:~      Control group: antibiotic prescriptions will be initiated and managed by the attending~     physicians Intervention group: antibiotic prescriptions will be systematically evaluated by~     the IDS and changed if judged necessary by the attending physicians, following IDS' advice.~      STUDY PROCESS: The study will took place in the emergency wards of 4 university hospitals.~     For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12~     months.~   "
185404|NCT01137851|"~     The purpose of this study is to assess the impact of patient cost sharing on treatment~     discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)~   "
185405|NCT01137838|"~     To compare the proportion of rheumatoid arthritis (RA) patients prescribed opioids,~     benzodiazepines, and antidepressants before versus after starting each of the following~     biologics: abatacept, infliximab, etanercept, adalimumab, utilizing an administrative claims~     database.~   "
185406|NCT01137825|"~     RATIONALE: Gathering information about older patients with cancer may help the study of~     cancer in the future.~      PURPOSE: This research study is gathering information from older patients with cancer into a~     registry.~   "
185407|NCT01137812|"~     The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared~     with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with~     metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.~   "
185408|NCT01137799|"~     This study in patients with stable schizophrenia will investigate the effect of JNJ-39393406~     on Event Related Potentials (Auditory Evoked Potential [AEP] P50, AEP P300 and Mismatch~     Negativity [MMN]) after single dose administration.~   "
185409|NCT01137786|"~     This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated~     contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled~     must have normal eGFR. Statistical summaries will be presented to analyse the various~     laboratory tests for the two groups.~   "
185410|NCT01137773|"~     Brain injury patients who meet defined criteria will be assigned to intensive insulin~     treatment (target blood glucose levels of 10-110 mg/dl) or conventional IV insulin treatment~     (target glucose of 150-170 mg/dl). Follow up will occur at 3, 6 and 12 months. The primary~     outcome measure will be neurological outcome at 12 months according to Karnofsky Performance~     Scale (KPS). A general view of outcome will also be presented as favorable (good recovery+~     moderate disability), unfavorable (severely disabled+ vegetative state), and dead.~      Secondary outcome measures will be blood glucose levels and death.The investigators will also~     record systemic complications like pulmonary emboli, pulmonary edema, myocardial infarction,~     ventricular arrhythmias, and pneumonia.~   "
185411|NCT01137760|"~     The purpose of this research study is to determine whether a functional fiber,~     galactooligosaccharide, can help maintain immune strength and digestive health in~     undergraduate students who are undergoing an academic stress (i.e., final exams). Subjects~     will be asked to consume the fiber or placebo each day for eight weeks. Immune and~     gastrointestinal health will be evaluated via daily questionnaires obtained from 420 students~     and from the collection of fecal samples in a subgroup of students.~   "
185412|NCT01137747|"~     This study is to test escalating doses of carfilzomib in patients with relapsed acute myeloid~     and acute lymphoblastic leukemia.~   "
185413|NCT01137734|"~     Annuloplasty device for repair of mitral valve regurgitation with option to adjust device~     post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional~     annuloplasty ring, the Cardinal system offers the clinician the opportunity to make~     adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce~     the number of patients leaving the operating room with residual regurgitation after mitral~     valve repair.~   "
185414|NCT01137721|"~     Sickle cell anemia (SCA) is a serious blood disease with blood vessel changes leading to~     brain injury and stroke. Studies show about 11% of patients with SCA will develop obvious~     stroke before age 20 years, with children less than 10 years of age especially vulnerable.~     The main objective of the SCDMR4[State Of The Art Functional Imaging In Sickle Cell Disease]~     trial is to compare the gray matter cerebral blood flow, measured by MRI,[magnetic resonance~     imaging] ASL [Arterial Spin Labeling] perfusion before treatment begins and after the~     appropriate hydroxyurea dosage is reached (~ one year). Other important objectives of the~     SCDMR4 trial include describing the effect of hydroxyurea therapy and transfusion therapy on~     the functional MRI response, diffusion tensor imaging of white matter, brain function, and~     transcranial Doppler blood velocities.~   "
185415|NCT01137708|"~     This study is designed to assess whether co-administration of CP-690,550 and oral~     contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.~   "
185416|NCT01137695|"~     The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who do~     not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin®) 3 times daily with~     expected glucose control require higher than FDA approved dosage.~      The primary objective of the study is to determine whether higher doses of pramlintide~     (Symlin®) in patients with type 2 diabetes mellitus control glucose better than the FDA~     approved dose of 120 mcg three times daily.~      The secondary objectives include proving whether higher dose pramlintide (Symlin®) is more~     efficacious in causing weight loss and reduction in waist circumference than standard dose~     pramlintide (Symlin®),to determine whether blood levels of certain hormones correlate with~     need for higher dose therapy,and to determine whether or not the rate of common adverse~     effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg three times~     daily.~   "
185417|NCT01137682|"~     This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus~     octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.~   "
185418|NCT01137669|"~     The purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX®~     (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with chronic kidney disease~     (CKD) who are scheduled to receive a living donor kidney transplant. ZOSTAVAX® is not~     licensed for use in immunosuppressed persons and in the United States for individuals less~     than 50 years of age. Subjects will receive either ZOSTAVAX® vaccine or placebo (inactive~     substance) no less than 4 weeks prior to their kidney transplant. Study procedures include:~     physical exam, blood samples and documentation of daily temperatures and/or side effects in a~     diary following vaccination. Participants may be involved in study related procedures for up~     to 18 months.~   "
185419|NCT01137656|"~     The purpose of this study is to explore the impact of aged blood on endothelial function by~     measuring forearm blood flow during intra-arterial acetylcholine infusion in normal healthy~     human volunteers after infusion of autologous blood stored for 5-10 days or 35-42 days.~      Our hypothesis is that 1) the vasodilatory response to the infusion of acetylcholine will be~     reduced in the 35-42 day group compared with the 5-10 day group, because of scavenging of the~     NO released from the endothelium by the hemolytic process in the aged blood, 2) that the~     infusion of aged stored blood will produce vasoconstriction, measured by reduced forearm~     blood flow during infusion of the 35-42 day compared with the 5-10 day old blood, and that 3)~     there will be increases in venous levels of cell free plasma hemoglobin, red cell~     microparticles, red cell membrane damage, arginase levels and activity, decreased arginine~     levels, markers of oxidative stress (carbamylated proteins and nitrated tyrosine residues),~     and increases in plasma in vitro NO consumption during the infusion of 35-42 day old compared~     to 5-10 day old blood.~   "
185420|NCT01137643|"~     RATIONALE: Collecting and storing samples of tissue, blood, and body fluid from patients with~     cancer to study in the laboratory may help the study of cancer in the future.~      PURPOSE: This research study is collecting and storing blood and tissue samples from patients~     being evaluated for hematologic cancer.~   "
185421|NCT01137630|"~     Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales)~     disorder patterned on the sebum-rich areas of the scalp, face, and trunk.~      The current treatment does not cure the disease permanently. Therefore it must be repeated~     when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the~     mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease,~     but are associated with a high frequency of relapse when treatment is stopped. They are~     reserved for acute flare-ups only as they may precipitate recurrences and dependence. In~     addition, chronic use of corticosteroids is associated with side-effects.~      The scientific rationale for the use of K40 for treatment of SD was based on clinical~     evidence that K40 improves erythema and desquamation with mild adverse reactions in a few~     cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b~     combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and~     desquamation scores at Week 4.~   "
185422|NCT01137617|"~     The purpose of this study is to better understand how the Spinal Cord Stimulator works in~     relieving chronic pain.~      The investigators are asking subject to take part in this study because who are chronic pain~     patients who already have a Spinal Cord Stimulator (SCS) in place.~      The investigators hypothesize that chronic pain patients will have higher heat pain threshold~     and heat pain tolerance over the painful areas with the SCS on.~      QST (Quantitative Sensory Testing, a heat/cold simulation test) might be an objective helpful~     tool for prudent patient selection for an expensive and invasive procedure for future SCS~     placement.~   "
185423|NCT01137604|"~     An open-label phase 2, multicenter study in participants with recurrent malignant glioma.~   "
185424|NCT01137591|"~     The purpose of this study is to compare the efficacy of the an N-acetyl-p-aminophenol (APAP,~     also known as acetaminophen) and N-acetylcysteine (NAC) combination versus an APAP-placebo~     combination as an anti-pyretic agent.~   "
185425|NCT01137578|"~     This protocol will serve as a pilot study to determine the validity and feasibility of~     contrast enhanced magnetic resonance imaging (MRI) without and with contrast and/or~     ultrasound (US) for detection of catheter related deep vein thrombosis (DVT) in children~   "
185426|NCT01137565|"~     The purpose of this study is to study the safety and tolerability in adolescent and adult~     subjects with intermittent or mild to moderate persistent asthma.~   "
185428|NCT01137539|"~     This is a pilot study to assess the feasibility and success of performing the TVT-Secur in~     the office setting. Endpoints would be success, complications, and patient and physician~     acceptance of the procedure. Success would be assessed by validated questionnaires.~      This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure~     done in the office under local anesthesia. They will be followed for a period of 3 years.~   "
185429|NCT01137526|"~     The purpose of this study is to test if the investigational medication, ABT-384, is a safe~     and effective treatment for adults with mild-to-moderate Alzheimer's Disease.~   "
185430|NCT01137513|"~     The purpose of this study is to measure T-Wave Alternans (TWA) in patients with acute~     coronary syndrome. Researchers are blinded to clinical TWA measurements. The investigators~     will then try to determine if T-Wave alternans correlates with clinical outcome of patients~     with Acute Coronary Syndrome. During routine care of the patient, the T Wave Alternans is~     measured.~   "
185431|NCT01137500|"~     Various haemodynamic changes are observed during laparoscopic surgery, relating to~     insufflation of CO2 & patient position. Cardiac output calculations using oesophageal doppler~     monitoring are based on the assumption that the aortic diameter is fixed. This study aims to~     measure the aortic diameter at preset times during surgery using ultrasound to discover if~     the diameter remains the same, and hence if the assumptions made by the oesophageal monitor~     are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement~     taken in patients electively having laparoscopic procedures at the Royal Surrey County~     Hospital.~   "
185432|NCT01137487|"~     Early enteral feeding is a key component of the management of critically ill patients~     receiving mechanical ventilation. However, enteral feeding has been associated with serious~     complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many~     critically ill patients experience poor tolerance of early enteral nutrition because of~     impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased~     gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of~     residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is~     assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that~     requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV~     measurement is neither standardized nor validated. The cut-off value that may indicate an~     increased risk of aspiration and therefore a need for discontinuing enteral feeding has not~     been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are~     available to support a correlation between RGV and the rates of adverse events. In~     experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The~     investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to~     inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the~     effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed~     a prospective randomized controlled study.~   "
185433|NCT01137474|"~     The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve~     (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who~     are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The~     safety of this treatment will also be studied.~   "
185434|NCT01137461|"~     The objective of this study is to evaluate the efficacy of embryo transfer procedure guided~     by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as~     the advantages and disadvantages of the new technique.~   "
185435|NCT01137448|"~     The purpose of this study is to evaluate the effect that weight loss has on the severity of~     psoriasis in obese subjects. Fifty obese (BMI equal to or greater than 30) patients with~     moderate to severe plaque psoriasis will be enrolled in a weight loss intervention program.~     The severity of their psoriasis will be reevaluated at month 3 and month 6 of the program to~     determine what effect weight loss has had on their psoriasis. Serum TNF-alpha will be~     measured at month 0 and month 6. The hypothesis that will be tested is that weight loss will~     lead to a significant improvement in the severity of psoriasis and a reduction in TNF-alpha~     levels.~   "
185436|NCT01137435|"~     This safety surveillance study is being conducted in accordance with Korea Food and Drug~     Administration (KFDA) Notification No. 2009-46 Basic standard for reexamination of new~     drug.~      The study objective is to assess within 30 days post-administration, the safety of ADACEL™~     administered under the real clinical practice.~   "
185437|NCT01137409|"~     The aim of this study is to determine if stress first pass imaging in conjunction with a~     nuclear scan will improve the sensitivity for detecting heart disease. This study will also~     test the usefulness of a nuclear medicine camera, CDLCAM One Pass Angiography system.~   "
185438|NCT01137396|"~     The medication modafinil has been shown to reduce cocaine use in some cocaine users. The~     investigators have shown that modafinil taken in the morning improves sleep in chronic~     cocaine users. The investigators hypothesize that the beneficial effects of modafinil in~     reducing cocaine use may be related to specific effects modafinil has on sleep. This study~     will measure sleep and cocaine use in cocaine dependent persons who are trying to stop using~     cocaine, and will test the connection between modafinil's effects on sleep and cocaine use.~   "
185439|NCT01137383|"~     The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD~     pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be~     treated using standard guidelines for hepatitis C. Response to treatment and side effects~     will be recorded.~   "
185440|NCT01137370|"~     Vitamin D has been regarded to be beneficial to tuberculosis (TB) patients. The aim of this~     study is to elucidate the role of vitamin D deficiency in development and treatment outcomes~     among Korean TB patients. Furthermore, the impact of genotypes of vitamin D receptor gene on~     TB development will also be evaluated.~   "
185462|NCT01137058|"~     Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time~     glycemic monitoring and glucose control implemented by clinical decision support system~     (CDSS) using wire and wireless communication and information technology.~      To evaluate the clinical efficacy of this system, researchers plan to compare the improvement~     of glycemic control, self-management, and quality of life among three study groups: control,~     self glucose monitoring, and U-healthcare group.~   "
185441|NCT01137357|"~     In vitro studies reveal immunomodulatory effects of probiotic bacteria that are~     strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated~     directly to in vivo efficacy. Thus, in vitro screening should be followed by comparative~     analysis of the selected immunomodulatory probiotic strains in an in vivo setting. Birch~     pollen allergy is one of the most common forms of respiratory allergy in European countries,~     and recognized by a Th2-skewed immune system. Five Lactobacillus strains will be evaluated~     for their immunomodulatory properties in birch pollen sensitive subjects outside the hay~     fever season. A double-blind placebo-controlled parallel study will be performed in which~     subjects with a proven birch pollen allergy will consume one of 5 different probiotic~     yoghurts containing 4 L. plantarum strains and 1 L. casei strain or a placebo yoghurt. Blood~     samples are collected at the start and after 4 weeks. Immune parameters are determined in~     serum and peripheral blood mononuclear cell cultures (hPBMC) derived from these subjects.~   "
185442|NCT01137331|"~     Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the~     head and trunk where sebaceous glands are most prominent. The severity varies from mild~     dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and~     thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the~     mildest form of the disorder affects up to 15-20% of the population.~      In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE~     patients are treated once daily for 4 weeks. The population for this study is patients with~     mild to moderate SE.~      The primary endpoint for this study is the efficacy of K301 compared to placebo which was~     based on the sum score for erythema and desquamation after 4 weeks of daily application.~     Secondary endpoints are to evaluate safety and tolerability as well as efficacy.~   "
185443|NCT01137318|"~     The objective of this study is to evaluate a novel sequenced combination of a promising,~     computerized cognitive training program targeting working memory (WM) deficits in children~     with attention-deficit/hyperactivity disorder (ADHD) in combination with behavioral parent~     training, a well-established, evidence-based intervention for ADHD.~      The combined active intervention, compared to the combined control intervention will result~     in improvement in primary psychosocial (i.e., parent/teacher reported child impairment;~     parental stress; parenting behavior; and observed child academic achievement) and psychiatric~     (parent/teacher rated ADHD, ODD, and CD symptoms; observed activity level and attention)~     outcomes at post-treatment and follow up assessment, with the combined active intervention~     resulting in greater improvements in these outcomes.~   "
185444|NCT01137305|"~     Background and hypothesis:~      Virtual reality (VR) training in minimal invasive surgery (MIS) is known to be feasible and~     beneficial in surgical residency. Research on stress- coping in surgical trainees indicate an~     additional impact of soft skills on VR- performance. Thus to hypothesize soft skills~     predicting surgical performance in a VR- setting.~      Method:~      A prospective randomized controlled single center educational trial was carried out to~     evaluate the impact of structured VR- training and defined soft skills such as self-~     efficacy, stress- coping and motivation on VR- performance.~   "
185445|NCT01137292|"~     Assessment of safety and efficacy of voriconazole in real-life setting in the treatment of~     high risk patients with invasive fungal infections. The study is conducted in Slovakia only.~   "
185446|NCT01137266|"~     The purpose of this study is to determine the effects of transcutaneous electrical nerve~     stimulation (TENS) on pain and mobility by comparing different stimulation sitesP:~        1. the location with the lowest resistance~        2. the location that causes an irradiation sensation~        3. a random stimulation site (but within a 10x10cm area of the irradiation site). The~          effect is defined as the pain VAS baseline-measurement before treatment minus the pain~          VAS repeat-measurement after the given treatment~   "
185447|NCT01137253|"~     The investigators are interested in the role of the autonomic nervous system in the~     regulation of endothelial function among obese hypertensive subjects. In particular, the~     investigators will study how endothelial function (response to intra-arterial acetylcholine)~     changes during autonomic withdrawal.~   "
185448|NCT01137240|"~     Hypothesis: Many patients with underlying mitochondrial disorders have feeding problems~     because of poor gastrointestinal motility; feeding problems lead to growth impairment and~     many affected children are malnourished.~   "
185449|NCT01137227|"~     Despite the acknowledgment that physical activity is important for health, there are still~     few population-based or school-based studies that uses the current physical activity~     guidelines for adolescents.~      Physical inactivity was defined a less than 300 min/w of moderate to vigorous-intensity~     physical activity practice.~      Previous research has shown very high prevalence rates of physically inactive adolescents and~     a strong association with demographic, socioeconomic and biological factors.~      Based on this information, the investigators are elaborating a systematic review of~     literature to obtain and provide more accurate information in this context.~   "
185450|NCT01137214|"~     The purpose of the project is:~        1. to determine the incidence of complex sleep apnea~        2. to determine what percentage of cases will resolve over time with therapy with~          Continuous Positive Airway Pressure~        3. Determine whether there is any difference in outcome, in those with persistent complex~          sleep apnea on CPAP, between those treated with CPAP or adaptive servo-ventilation.~   "
185451|NCT01137201|"~     To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better~     than leaving them open.~   "
185463|NCT01137045|"~     A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new~     chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically~     purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial~     Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using~     with post-exposure rabies intradermal vaccination with or without equine rabies~     immunoglobulin.~   "
185464|NCT01137032|"~     The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate~     cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult~     subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface~     area.~   "
185465|NCT01137019|"~     The purpose of this study is to use a high-resolution intracoronary imaging modality, called~     optical coherence tomography (OCT) to examine two different types of coronary artery stents~     used to treat patients with coronary artery disease.~   "
185452|NCT01137188|"~     Controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity~     is correlated with the degree of overweight. No controlled interventional studies reporting~     on the effect of weight loss on psoriatic skin manifestations have been published and data~     from case reports are conflicting.~      Patients with psoriasis demonstrate an increased susceptibility to atherosclerotic~     comorbidities such as arterial hypertension, coronary vascular disease, stroke,~     hyperlipidemia and type II diabetes and in severe psoriasis there is an increased risk of~     early death. Lately the role of inflammation in the atherosclerotic process has been~     highlighted and the link between psoriasis and atherosclerosis may be explained by the~     concomitant systemic inflammation in psoriasis. Similarly a state of low level inflammation~     is seen in obesity where macrophages and adipocytes begin to show overlap in function and~     gene expression. This leads to an increased migration of macrophages into the adipose tissue~     and an increased secretion of pro-inflammatory cytokines. In summary, these data and~     theoretical considerations suggest that weight loss in obese patients with psoriasis may~     improve skin manifestations and reduce the risk of atherosclerotic comorbidity.~   "
185453|NCT01137175|"~     The low confirmed rickettsioses cases rate may indicate the presence of rickettsiosis other~     than scrub typhus, murine typhus, and Q fever. The clinical presentation of rickettsiosis is~     variable and atypical that laboratory confirmation is necessary. This project is aimed to set~     up the laboratory to diagnose rickettsial and rickettsial like disease, which could help in~     develop rapid diagnostic kits, epidemiologic surveillance and prognostic factor.~   "
185454|NCT01137162|"~     Cetuximab, erlotinib, and panitumumab are all recently FDA approved epidermal growth factor~     receptor (EGFR) inhibitors that treat a wide variety of tumor types, such as colon, lung, and~     head and neck. Blockade of the EGFR results in inhibition of multiple downstream pathways,~     leading to slowed tumor growth. In addition, these inhibitors may enhance anti-tumor immune~     responses through uncharacterized mechanisms. While producing significant responses in many~     settings, EGFR inhibitors also result in significant skin toxicity (rash) in a high~     percentage of patients. Multiple studies have correlated the presence and severity of rash~     with clinical response. Unfortunately, severe rash can often lead to dose delays, reductions,~     or even discontinuation of EGFR inhibitors, thus limiting their efficacy. The mechanism of~     both the rash and its correlation with tumor response is poorly understood. Skin biopsies~     display a robust leukocyte infiltrate, but a systematic analysis of the type of infiltrating~     leukocytes, activation state, or homing receptor expression has not been performed.~     Chemokines and chemokine receptors control leukocyte trafficking to the skin and other tissue~     sites, and defined receptor profiles for skin-, gut-, and lung-homing leukocytes are well~     established. In this study, the investigators propose to evaluate the homing phenotype of~     leukocytes from peripheral blood and skin biopsies of patients receiving EGFR inhibitors. The~     investigators will use RNA microarrays to evaluate the expression of chemokines and other key~     genes regulated in skin during treatment. The investigators will utilize in vitro methods to~     investigate effects of EGFR inhibitors on imprinting of T cell tissue-specific homing~     receptors. The investigators will examine correlations among the pathologic data, clinical~     findings, and tumor response. If validated, peripheral blood evaluation could potentially be~     used as a predictive indicator for patients receiving EGFR inhibitors. This study may also~     identify novel targets for limiting skin toxicity while receiving EGFR inhibitors, thus~     allowing maximal dosing and clinical response from these agents.~   "
185455|NCT01137149|"~     Twenty percent of adolescents will have at least one episode of clinical depression by age~     18, and 65% will experience transient or less severe depressive symptoms. Depression~     compromises the process of adolescent development by interfering with academic, occupational,~     and social functioning, and increasing risk for substance use and suicide. Although initial~     research provides some support for both pharmacological and psychosocial interventions, many~     depressed teens do not respond to these interventions, and others experience a relapse of~     symptoms within one year. Furthermore, concerns about antidepressant medications increasing~     suicide risk have raised additional caution about use of pharmacotherapy with adolescents. As~     such, the importance of developing innovative treatment options for depressed adolescents is~     critical. Cognitive Behavioral Therapy (CBT) has been demonstrated to be effective in the~     treatment of depressed adults, with more modest efficacy data when used with children and~     adolescents. Interestingly, recent data from the adult literature suggests the positive~     outcomes of CBT can be achieved and surpassed by interventions that are purely behavioral in~     nature. Behavioral interventions may be easier to implement with many adolescents and may~     provide a better developmental fit for depressed adolescents. The present project proposes to~     develop a manualized Behavioral Activation (BA) Therapy for depressed adolescents, test its~     adaptability, acceptability, and feasibility in an open clinical trial with 12 adolescents~     (aged 12-17), and following further treatment refinement, test its efficacy in a randomized~     controlled trial of 50 adolescents (aged 12-17), in which 25 will be randomized to BA Therapy~     and 25 will receive Treatment as Usual (TAU). In this randomized controlled trial,~     depressed adolescents will receive 12-weeks of BA Therapy or TAU. Psychiatric and~     psychosocial functioning will be assessed at the beginning, middle, and end of treatment. A~     naturalistic follow-up will be conducted 4 and 9 months post-treatment. Assuming that BA will~     outperform usual approaches to therapy with depressed youth, the data will provide the~     basis for the development of a larger randomized controlled trial comparing the efficacy of~     BA against other widely studied approaches to the treatment of depression in youth, namely~     pharmacotherapy in the form of Selective Serotonin Reuptake Inhibitors (SSRIs), and CBT.~   "
185456|NCT01137136|"~     Aromatase(CYP19)inhibitor is one of the major antihormonal drug for breast cancer in~     postmenopausal women. The variation of CYP19 may affect the effect of aromatase inhibitor.~     However, the incidence of variation of CYP19 in Korea has not known. Therefore, the~     investigators want to know the incidence of variation of CYP19 and to assess the effect of~     these variations of CYP19 to aromatase inhibitor users.~   "
185457|NCT01137123|"~     The purpose of this study is~        1. To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on~          the staging and prognosis of resectable esophageal cancer, which defined by the~          International Association of esophageal disease(ISDE) - standard mediastinal~          lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to~          find out reasonable range of lymphadenectomy.~        2. To compare the effects of Chemotherapy Group (Docetaxel + Nedaplatin) with Control Group~          on the prognosis of resectable thoracic esophageal cancer,and to explore the indications~          of adjuvant chemotherapy.~   "
185458|NCT01137110|"~     Our primary objective is to compare two treatment options for prevention of seizures~     following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam~     is as efficacious in the prevention of in-hospital seizures when compared to an extended~     course.~   "
185459|NCT01137097|"~     Objective: To investigate the incidence of lateral neck node occult metastasis and to show~     the usefulness of sentinel lymph node biopsy (SLNB) in the detection of lateral neck node~     metastasis in thyroid carcinoma, the investigators used a radioisotope to detect the sentinel~     lymph node.~      Summary Background Data: Although occult lymph node metastasis to the lateral neck~     compartment is common in papillary thyroid carcinoma, the incidence and patterns of lateral~     neck node metastasis in papillary carcinoma are not known.~   "
185460|NCT01137084|"~     The purpose of this study was to evaluate the safety and efficacy of a steroid-free~     immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.~   "
185461|NCT01137071|"~     RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy~     for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube~     cancer.~   "
185467|NCT01136993|"~     Objective is to describe two years experience from The Finnish Telestroke piloting between~     Helsinki University Central Hospital (HUCH), Department of Neurology, The Hub, and five~     hospitals, the spokes. The participating hospitals are from Rovaniemi (Lapland), Kemi~     (North-West of Finland), Lappeenranta, Kuusankoski and Kotka from South-East of Finland. All~     the participating hospitals have a stroke unit and the thrombolysis treatment and the follow~     up of the patients are carried in the treating hospital. The aim of the pilot is to provide~     these hospitals expertise in thrombolysis treatment during off-hours through~     teleconsultations.~      The teleconsultations were begun between the participating hospitals 05/2007 after about 1~     years preparation period. During the preparation period the staff from participating~     hospitals were trained with simulation training and lectures held by the local staff and the~     faculty of the Helsinki University hospital.~      Telestroke consultation: During two way interactive audio-visual consultation the~     thrombolysis decision is based on: 1) the consultant going through a check up list of~     indications and no contraindications to the treatment together with the treating physician~     and 2) Clinical assessment of NIHSS by the treating physician under guidance of the~     consultant through the two way video system besides 3) Evaluation of the head CT scan.~      The data registered is based on documents made at HUCH and the follow up data provided by the~     chief neurologist of the other hospitals. 109 teleconsultations have been documented over 2~     years period. A unique feature of the Finnish pilot is the high percentage of consultations~     leading to thrombolysis treatment. Another special feature is that the consultant does the~     teleconsultation work besides other on call duties.~   "
185468|NCT01136980|"~     The objective of the study is to evaluate the relative merits, safety and effectiveness of~     the EsophyX transoral device in performing an advanced TIF procedure in patients with~     troublesome symptoms as defined by the Montreal consensus definition while on PPIs compared~     with sham and placebo controls.~   "
185469|NCT01136967|"~     The purpose of this study is to assess the objective response rate of lenvatinib in~     previously treated participants with American Joint Committee on Cancer (AJCC) unresectable~     Stage III or Stage IV melanoma and disease progression.~   "
185470|NCT01136954|"~     The purpose of this study is to assess the long-term safety and efficacy of zonisamide used~     as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic~     drugs (AEDs).~   "
185471|NCT01136941|"~     The purpose of this research study is to test the safety of Zileuton and see what effects~     (good and bad) it has on you, other children and adults with Sickle Cell Disease (SCD). The~     investigators also want to see how Zileuton is handled by your body at different doses.~      Zileuton is a drug that is approved by the Food and Drug Administration (FDA) for the~     treatment of asthma for people age 12 and older. The FDA has not approved Zileuton for the~     treatment of SCD, so it is being studied as an investigational drug for SCD through an~     application to the FDA. In asthma patients, Zileuton helps by reducing inflammation. This~     study will see if Zileuton helps to reduce inflammation associated with SCD.~   "
185472|NCT01136928|"~     This is a 4-week sequential drug interaction study to measure the effects of American ginseng~     on efavirenz pharmacokinetics using steady-state 24-hour AUC and Cmax as the primary~     comparison measures in healthy male volunteers. Efavirenz Cmin, T1/2, tmax, and clearance~     will also be assessed as secondary outcome measures. This study is a phase I, prospective,~     within-subject, fixed-order, two-period, multiple dose, open label, drug interaction study,~     to determine the stead-state plasma pharmacokinetic profile of efavirenz before and after~     concurrent treatment with American ginseng. The investigators hypothesis is that concurrent~     oral administration of American ginseng for up to 14 days will not significantly alter the~     steady-state plasma pharmacokinetic of efavirenz.~   "
185473|NCT01136915|"~     This is a pilot study using a randomized, double blinded, comparison of two iodinated~     contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled~     must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. Statistical~     summaries will be presented to analyse the various laboratory tests for the two groups.~   "
185474|NCT01136902|"~     The overall objective is to investigate, whether retinal blood vessel diameter change during~     the energy consuming dark adaptation process and if responses vary between low and high blood~     glucose.~   "
185475|NCT01136889|"~     1. To determine the feasibility of conducting a randomised controlled trial (RCT) of the~          effectiveness of a PFMT intervention in conjunction with vaginal pessary management~          versus vaginal pessary management alone for women with pelvic organ prolapse.~        2. To develop and test the methods for a main trial.~      The ultimate aim of a large multi-centre RCT would be to answer the question:~      Is conservative management of pelvic organ prolapse with an individualised PFMT intervention~     in conjunction with vaginal pessary more effective than vaginal pessary alone in reducing~     prolapse-specific symptoms, prolapse severity and the need for further prolapse treatment?~   "
185476|NCT01136876|"~     This is a pilot study having a randomized, double-blind parallel group comparison of two~     iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients~     enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59~     mL/min. Statistical summaries will be presented to analyze the various lab tests results for~     the two groups.~   "
185477|NCT01136863|"~     FEVER is an investigator-designed, prospective, multicentre,double-bind, randomized,~     placebo-controlled,parallel-group trial. The primary objective is to compare the long-term~     effects on the incidence of fatal and non-fatal stroke (and secondarily of other~     cardiovascular events) of administering a small dose of the calcium antagonist felodipine (5~     mg once a day) or of a placebo, in hypertensive patients whose blood pressure had~     preliminarily been reduced by administering a low-dose diuretic (hydrochlorothiazide,12.5 mg~     once a day) to be continued in association with felodipine or placebo, throughout the trial.~   "
185478|NCT01136850|"~     The purpose of this study is to determine whether repeated courses of~     sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic,~     leads to lower rates of low birth weight deliveries (<2.5 kg) among Papua New Guinean women,~     than the current standard treatment of SP and chloroquine.~   "
185479|NCT01136837|"~     To investigate the prognostic significance of a fragmented QRS (fQRS) complex in a patient~     who had undergone primary percutaneous coronary intervention (PCI).~   "
185481|NCT01136811|"~     The purpose of this study is to evaluate the preliminary safety and efficacy of the daVinci~     surgical system (computer-assisted surgery) for use in vascular surgery procedures. Although~     the daVinci Surgical System is FDA approved and widely used for surgical procedures for~     urology, cardiac, general, and gynecologic procedures, it is not currently approved~     specifically for use in vascular surgery and the FDA has required the PI to conduct a small~     feasibility study under an IDE. The investigators are seeking approval by the FDA to utilize~     the daVinci Surgical System in vascular surgery and to conduct a future clinical trial.~   "
185482|NCT01136798|"~     The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment~     in patients with type 2 diabetes results in improved sleep duration and quality and to~     explore the relationship between improvements in sleep and measures of metabolic and~     circadian function. This project would be the first to probe the relationship between~     incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian~     dysfunction in diabetic patients.~   "
185483|NCT01136785|"~     The overall goal of the proposed protocol is to rigorously test the hypothesis that CPAP~     treatment has beneficial effects on glycemic control in patients with both type 2 diabetes~     (T2DM) and obstructive sleep apnea (OSA). If our hypothesis were to be proven, this would~     imply that CPAP treatment of OSA in patients with T2DM is an essential component of their~     glycemic control. The proposed work is thus expected to provide additional preventive and~     therapeutic approaches in the management of millions of patients with T2DM.~   "
185484|NCT01136772|"~     The purpose of this research study is to compare the real-world effectiveness of two~     FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone~     palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective~     disorder who are expected to benefit from the improved medication compliance associated with~     injectable medications. The goal is to evaluate the effects of the medications on outcomes of~     importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy~     makers (all of the above plus costs).~   "
185485|NCT01136759|"~     Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of~     transmission of HIV. Pregnant women and mothers who have recently given birth often maintain~     sexual activity, and research has shown that they may be at greater risk of HIV infection~     during pregnancy. Microbicides may be able to prevent HIV infection during pregnancy, which~     would also prevent fetal exposure to HIV. This study will test the safety of using tenofovir~     1% gel in healthy, pregnant women and healthy, breastfeeding women.~   "
185486|NCT01136746|"~     The purpose of this study is to compare the use of insulin glargine plus insulin lispro to~     human regular insulin for treatment of hyperglycemia in the hospital setting in patients~     without known prior history of diabetes.~   "
185487|NCT01136733|"~     This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination~     with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma~     following one prior VEGF-targeted treatment.~   "
185488|NCT01136720|"~     18F-FDG produced in the MIRC NS has a similar safety profile to the same compound utilized~     elsewhere in that no significant adverse events will occur during observation of the patients~     for 2 1/2 hours post injection of the tracer. It is also hypothesized that as this FDG~     produced by similar methodology and its quality assurance assessed as in another~     jurisdictions will have similar performance parameters in patients with focal lung pathology~     to that previously determined.~   "
185489|NCT01136707|"~     The purpose of this study is to examine the relationship between loading dose and adherence~     to Orencia.~   "
185490|NCT01136694|"~     The purpose of this study is to explore the differences in productivity loss and costs~     between patients being treated for rheumatoid arthritis (RA) with biologic disease-modifying~     antirheumatic drugs (bDMARDs) compared to patients treated with conventional DMARDs.~   "
185491|NCT01136681|"~     The investigators are developing a research platform capable of improving children's health~     through the generation of knowledge from analysis of routinely collected data from within and~     outside the health service.~      The investigators are using the data that are routinely collected in Wales to answer specific~     questions about child health and well-being, with the aim of informing policy and practice in~     Wales, whilst also being internationally relevant.~      Routinely collected datasets are publicly funded, and have already been incorporated into the~     Secure Anonymised Information Linkage databank. The investigators are combining these~     datasets on children from health and social care to establish an anonymised Wales wide~     Electronic Cohort for Children (WECC). WECC will serve as the platform for future work in~     translating information into child population health policy.~      There are 35,000 births in Wales per year, and data are available for the previous ten years.~     Thus, WECC will be sufficiently powered to answer important social, economic and health~     policy questions. WECC will also act as a demonstration project which would inform the~     development of e-cohorts to support translational research across the life course and disease~     spectrum.~   "
185492|NCT01136668|"~     The primary objective of this study is to determine if the use of Transversus Abdominis Plane~     (TAP) blocks reduce early postoperative opioid requirements.~   "
185493|NCT01136655|"~     This purpose of the study is to investigate the bronchodilating effects of 3 different~     dosages of formoterol given in combination with budesonide as Symbicort pMDI.~   "
185510|NCT01136421|"~     Treatment with short acting β2 agonists for exacerbations of COPD results in clinical~     improvement. It has not been established whether combining short acting β2 agonists to other~     bronchodilators is more effective than β2 agonists alone. The aim of this study is to~     evaluate the efficacy and safety of combination of SABA and MgSO4 in comparison to SABA and~     ipratropium bromide (IB) in patients attending the emergency department for AECOPD.~   "
185511|NCT01136408|"~     The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048)~     administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with~     non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with~     warfarin.~   "
185523|NCT01136252|"~     Adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor~     necrosis factor. This study will assess the safety and efficacy of intravitreal adalimumab~     administered in patients with choroidal neovascularization secondary to age-related macular~     degeneration non-responders to the conventional treatment with intravitreal ranibizumab.~   "
185494|NCT01136642|"~     Background:~        -  Smoking is the leading cause of preventable death in the United States, and researchers~          are interested in gaining a better understanding of the perceived beneficial effects of~          nicotine to help improve treatment strategies for nicotine dependence. Understanding the~          conditions under which nicotine improves attention and cognitive processing may provide~          more useful information for this research.~        -  The ability to pay attention and filter relevant from irrelevant stimuli is central to~          all aspects of information-processing. Top-down and bottom-up attentional processes~          illustrate how the brain combines stimuli and goal-directed behaviors. Bottom-up~          processing is an unconscious response to sensory input; for instance, when the eyes~          automatically focus on a prominent image in a picture. Top-down processing is a~          conscious response to drive attention toward specific stimuli; for instance, when a~          person is asked to focus on a less immediately noticeable image in a picture.~          Researchers are interested in determining whether nicotine improves cognitive~          performance by acting on top-down or bottom-up attentional mechanisms.~      Objectives:~      - To investigate the effect of nicotine on the top-down and bottom-up mechanisms of attention~     in cigarette smokers.~      Eligibility:~      - Current smokers (at least 10 cigarettes per day for at least 1 year) between 18 and 55~     years of age.~      Design:~        -  This study will involve one training session and four experimental sessions.~        -  During the training session, participants will receive a sample dose of the nicotine~          nasal spray used in the study to determine if they can tolerate the effects.~        -  For each experimental session, participants will receive one dose of nicotine nasal~          spray (1 mg, 2 mg, or 3 mg) or placebo spray, followed by blood pressure and heart rate~          monitoring, performance of an attentional test, and questionnaires to rate participants~          perception of nicotine effectiveness. Participants may receive different doses at~          different sessions, and will not be told which dose they will receive at any given~          point.~   "
185495|NCT01136629|"~     Hypothesis -~      The developments of solar lentigine and melasma are due to mutations in keratinocytes that~     drive the production and transfer of pigment from melanocytes to keratinocytes.~   "
185496|NCT01136616|"~     Hypothesis: There are 5 support buttresses in the complex osteocartilaginous architecture of~     the nose.~        1. The membranous septum;~        2. The Right nasal bone;~        3. The Left nasal bone;~        4. The perpendicular plate of the ethmoid;~        5. The vomer, vomerine groove and anterior nasal spine.~   "
185497|NCT01136603|"~     Hypothesis: TIGR mesh as a reconstruction material is a more effective mesh for the repair of~     the abdominal wall post lipectomy, transverse rectus abdominis myocutaneous (TRAM) / deep~     inferior epigastric perforator (DIEP) flap.~   "
185498|NCT01136590|"~     Current evidence regarding the efficacy and safety of perioperative administration of~     tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal~     surgery.~      OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion~     requirements and bleeding in this patient population. To evaluate the safety of this~     antifibrinolytic agent in the intraoperative and mid-term postoperative period.~      METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with~     parallel groups. The main outcome measure is intraoperative and postoperative transfusion~     requirements; blood loss and safety will also be evaluated. Previous results in other types~     of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss.~     Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood~     loss in comparison to a placebo in major spine surgery.~   "
185499|NCT01136577|"~     Phototherapy is almost (beside exchange transfusion) the unique treatment for~     hyperbilirubinemia of the newborn. Its efficacy to decrease bilirubin level (because the~     light interacts with bilirubin at the skin level to transform it in water soluble products~     eliminated in urine and stools without liver metabolism) relies on the irradiance dispensed~     at the skin level by the device (in the 430-490nm range) and on the exposed surface of the~     baby. In the past years, technology of phototherapy devices moved from fluorescent lamps to~     LED, improving the amount of light energy emitted but on a smaller surface. The purpose of~     the study is to compare the efficacy of three ramps of phototherapy, one equipped with~     fluorescent tubes and two with LED (in a different technological settings) in the treatment~     of term (35 GW or more) healthy newborn suffering hyperbilirubinemia after 2days of life.~   "
185500|NCT01136564|"~     Recently it has been documented that vitamin D has important functions in the human body that~     are unrelated to its primary effects in calcium homeostasis and bone mineralization. In~     clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to~     decrease proteinuria, a marker of disease progression and cardiovascular risk in patients~     with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of~     a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.~   "
185501|NCT01136551|"~     The purpose of this study is to develop oral controlled release formulation of Huperzine A~     that will provide optimal pharmacokinetic profile of the drug enhancing safety and~     compliance, as possible cure to neurodegenerative disorders.~   "
185502|NCT01136538|"~     The purpose of this study is to~        1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl~          tablets of Dr. Reddy's and Valtrex (R)(Valacyclovir Hydrochloride)CAPLETS 1 gram of~          GlaxoSmithkline, in healthy, adult human subjects under fed conditions.~        2. monitor the adverse events and ensure the safety of subjects.~   "
185503|NCT01136525|"~     The purpose of this study is to~        1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl~          tablets of Dr. Reddy's and Valtrex (R)(Valacyclovir Hydrochloride)CAPLETS 1 gram of~          GlaxoSmithkline, in healthy, adult human subjects under fasting conditions.~        2. monitor the adverse events and ensure the safety of subjects.~   "
185504|NCT01136512|"~     The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on~     metformin therapy for diabetes.~   "
185505|NCT01136499|"~     The purpose of this study is to assess efficacy and safety of LBH589 - Panobinostat®, a~     potent HDACi, in patients with advanced STS who experiment disease progression after or~     during first-line chemotherapy. The rational is based on the observation of activity of~     deacetylase inhibitor (DACi) in several pre-clinical models of STS including Synovial sarcoma~     and Ewing sarcoma.~   "
185506|NCT01136486|"~     The observation through a chart review of persistent pain on neuro psychological functioning~     and how it applies to the community integration with patients that had suffered traumatic~     brain injury.~   "
185507|NCT01136473|"~     In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to~     aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of~     candidate factors will be performed before and after exposure to lens epithelial.~   "
185508|NCT01136460|"~     Primary congenital glaucoma patients and their immediate relatives will undergo complete~     ophthalmic examination and an interview with a geneticist. A blood sample will be drown from~     all participants for DNA analysis.~      The CYP1B1 gene coding sequences will be screened for all individuals. If no mutation or only~     one heterozygous mutation will be found in the CYP1B1 gene, screening for MYOC gene mutations~     will be performed.~   "
185512|NCT01136395|"~     This project comprises immunological and virological analyses within a prospective clinical~     study of Rituximab (Rtx)-treated blood group incompatible living donor (LD) renal transplant~     recipients compared to blood group compatible LD recipients without Rtx induction, and of~     living donor compared to deceased donor renal transplant recipients treated with tacrolimus~     (Tacr)/mycophenolate sodium (MPS). Aim of this project is to assess short- and long-term~     effects of immunosuppressive therapy (Rtx induction) and of living donation on immunological~     and histological parameters of graft outcome and on viral replication (BK, JC, CMV, EBV) with~     the potential to improve long-term graft outcome and to enable risk estimation of virus~     disease.~   "
185513|NCT01136382|"~     This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6~     weeks is effective and safe in treating asthmatic children aged 6 to <12 years~   "
185514|NCT01136369|"~     The study will determine the sensitivity, specificity, negative predictive value and positive~     predictive value of the OSNA Breast Cancer System by comparing its performance to permanent~     section Hematoxylin and Eosin (H&E) and IHC staining.~   "
185515|NCT01136356|"~     Buprenorphine is an approved medication for the treatment of opioid dependence. It is~     typically administered once daily as a sublingual tablet combined with naloxone (i.e.,~     Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical~     dependence. In addition, some research suggests there is relatively little withdrawal~     following cessation of chronically administered buprenorphine. This study will examine the~     spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine~     in opioid dependent individuals. This study will assess the characteristics and time course~     of withdrawal using subject-rated and observer-rated measures of opioid withdrawal.~     Physiologic measures and psychomotor performance will be collected during chronic opioid~     administration and during placebo administration (i.e., during spontaneous withdrawal).~     Particular attention will be paid to the differences (if any) in sleep disturbances and~     withdrawal associated hyperalgesia.~   "
185516|NCT01136343|"~     In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten~     leading causes of death in female in 2007; half of these deaths is due to coronary artery~     disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment~     and proper management of risk factors may reduce the prevalence rate of CAD. In the past~     decade, despite increased attention to CAD in women, most studies focused on certain~     menopausal status instead of all phases of menopause or on risk factors limited to related~     metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by~     various physiological and lifestyle status in different menopausal statuses, the purpose of~     this study, at the first stage, is to explore respectively the risk factors of CAD among~     middle-aged women in three menopausal statuses. At the second stage, the influence of a~     lifestyle management program on risk factors modification among pre-menopausal women is~     examined in this study.~   "
185517|NCT01136330|"~     Myotonic dystrophy type 1 (DM1) is the most frequent neuromuscular disease in adults. DM1~     patients have an impaired prognosis (mean age of death <60 years) due to cardiac and~     respiratory complications.~      Our primary objective was to identify cardiac and respiratory prognostic factors in DM1.~   "
185518|NCT01136317|"~     This study aims to determine, in obese subjects, the antisecretory effect of a single dose of~     placebo, rabeprazole 20 mg and omeprazole 20 mg using 24h gastric pH monitoring, in a~     prospective, monocentre, randomized manner. Monitorings are separated between 6 and10 days.~     The main outcome criteria of analysis is the percentage of time with gastric pH above 3~     during 24hours.~   "
185519|NCT01136304|"~     With the participation of an international consortium of investigators, the investigators~     will evaluate the validity of a new severity score system called DS3 for adult patients with~     Gaucher disease. The investigators hypothesize that initial DS3 scores will be predictive of~     both disease progression and patterns of response including imiglucerase dose sensitivity and~     completeness and maintenance of response and that sequential DS3 scores will accurately~     portray either clinical progression of disease or improvement in response to treatment. The~     investigators will also collect DNA specimens that in future research will be used in~     conjunction with the DS3 scores to evaluate determinants of the clinical course and the~     response to treatments for Gaucher disease.~   "
185520|NCT01136291|"~     Objective: To evaluate the association between physical exercise for obese or overweight~     women and the maternal, perinatal outcomes and perception of these women about their quality~     of life.~      Methods: A randomized controlled clinical trial with 78 pregnant women. Overweight or obese~     (BMI ≥ 26 kg / m²), gestational age between 14 and 24 weeks and from age 18 years were~     included. They will be divided into two random groups: one which will an exercise program~     under supervision and guidance received from home exercises (study group) and another that~     followed the standard routine prenatal care service (control group). Both groups will receive~     standardized nutritional counseling by the department of nutrition and dietetics and a~     questionnaire measuring quality of life WHOQOL-short at 14 - 24 weeks and at 36 weeks of~     pregnancy. The intervention results will be analyzed by intention to treat. A P value less~     than 0.05 will be used to determine statistical significance.~   "
185521|NCT01136278|"~     The purpose of this study is to determinate the effect of a pre-treatment with centrally~     acting alpha2-receptor agonist clonidine on the pharmacodynamics and pharmacokinetics of~     3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The investigators hypothesize that~     clonidine will attenuate the subjective and cardiovascular response to MDMA.~   "
185522|NCT01136265|"~     In this study, the investigators want to pre-operatively scan patients who do not have any~     clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they~     go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Material from the oral~     cancer and, after permission of each patient, also normal oral tissue will be analyzed~     molecular-biologically. Also a blood sample will be analyzed for molecular tumor markers.~      The investigators want to see if PET/CT is able to detect any signs of sub-clinically~     metastases. Besides, the investigators want to fusion PET/CT with SPECT/CT data from the~     lymphoscintigraphy study and improve our PET/CT scanning with a dual-time PET scan of the~     head-and-neck region.~   "
185524|NCT01136239|"~     This study is to investigate the add-on effect of high dose NAC (600mg tablet twice daily) on~     reduction of airtrapping and airway resistance in stable COPD patients as well as to study~     it's effect in reducing exacerbation, improving exercise capacity and quality of life in~     stable COPD patients.~   "
185526|NCT01136213|"~     Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult~     associated to a poor prognosis. MSA is clinically characterized by the association of~     extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. Histological and biological~     studies have raised the hypothesis that, beside the well known dopamine deficiency, some of~     the symptoms could be related to a dysfunction in serotoninergic neurotransmission. Serotonin~     is involved in the modulation of several functions impaired in MSA, such as mood, motricity~     or sleep. The recent description of an association between loss of brainstem serotonin~     neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role~     played by this neurotransmitter in the pathophysiology of this disease. Autoreceptors called~     5-HT1a are strongly involved in the regulation of serotonin neurotransmission. During the~     last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors,~     such as 18F-MPPF~     (4-(2'-methoxyphenyl)-1-[2'-(N-2''-piridinyl)-p-fluorobenzamide]methylpiperazine), were~     developed. Moreover, the investigators recently demonstrated the ability of this brain~     functional imaging method to investigate, in healthy volunteers, the functional properties of~     5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose~     of fluoxetine.~   "
185527|NCT01136200|"~     CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions~     ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve~     the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet~     fully estimated using a randomized trial to compare the quality of care of patients who will~     benefit of the intervention.~      OBJECTIVES: To show using a randomized trial that patients with IDS advice will receive more~     appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients~     who will not receive IDS advice.~      METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of~     prescriptions in two groups of patients:~        -  Control group: antibiotic prescriptions will be initiated and managed by the attending~          physicians~        -  Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS~          and changed if judged necessary by the attending physicians, following IDS' advice.~      STUDY PROCESS: The study will took place in 4 university hospitals. Two medical or surgical~     wards will participate by hospital. For each ward, the period of the study will be 2 x 4~     weeks.Total duration of the study: 12 months.~   "
185528|NCT01136187|"~     Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding~     complications related to access site in comparison to the radial approach in patients with~     acute coronary syndrome (ACS). Major bleeding and access site complications have an important~     role in results of PCI for ACS and lead to higher morbidity and mortality. Primary PCIs in ST~     elevation myocardial infarction (STEMI) are associated with more aggressive antithrombotic~     treatment than in elective or semi-urgent interventions. Currently, both radial and femoral~     approaches are routinely used for primary PCI in STEMI. However, only non-randomized studies~     and registries or small randomized single center studies comparing both approaches in primary~     PCI have been published until now. The aim of STEMI-RADIAL trial is to evaluate potential~     reduction of bleeding complications in the radial approach primary PCI compared to femoral~     approach in randomized, multicenter study.~   "
185529|NCT01136174|"~     To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis~     (IPF), with and without pirfenidone background treatment.~      To assess pharmacokinetics of BIBF 1120 in Japanese patients, with and without pirfenidone~     background treatment.~      To assess pharmacokinetics of pirfenidone in Japanese patients, alone and in combination with~     BIBF 1120 treatment.~   "
185530|NCT01136161|"~     The aim of the trial is to assess the safety, tolerability and immunogenicity of two doses of~     RUTI® vaccine administered four weeks apart after one month pre-treatment with INH.~      The trial will be double-blinded, randomized and placebo-controlled with 96 subjects (48 HIV-~     and 48 HIV+ subjects).~      Three different RUTI® doses and placebo will be tested, randomizing assigned both in HIV+ and~     HIV- subjects. Each subject will be randomized to receive one of the four treatments~     (placebo, 5, 25, 50 μg), after completion of one month INH pre-treatment (one tablet of~     300mg/day, vp.o.). Each subject will receive two administrations of the same treatment, 28~     days apart. Subjects will be monitored until one month after the second inoculation with~     RUTI®.~   "
185531|NCT01136148|"~     This research is an evaluation of the MMHU compared to standard care. Patients who are over~     65 and 'confused' at admission will be randomly allocated to the MMHU or standard care. The~     MMHU does not have capacity for all confused older patients admitted to NUH, and random~     allocation is similar to what happens in practice currently. For this study, 480 of these~     patients will be recruited, together with a carer (240 from the MMHU, 240 from standard care~     wards). The investigators will collect baseline information about the patient participant's~     physical and mental health and disability.~      The investigators will count the total days spent at home and measure patient participants'~     health status after 3 months, and use of resources over six months. Carer strain and quality~     of life will be measured at baseline and follow up.~   "
185532|NCT01136135|"~     To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial~     biopsies for serial detection (EMB) and follow-up of cellular rejection in heart transplant~     in childhood.~   "
185533|NCT01136122|"~     The purpose of this study is to see if treatment of OSA with the CPAP device makes a~     difference to insulin resistance and heart disease.~   "
185534|NCT01136109|"~     Previous research has shown that the Inferior Vena Cava Collapsibility Index (IVCCI) can be~     used to assess volume status. One limitation of the previous work is that changes in~     intra-thoracic pressure can influence this measurement, and the magnitude of this effect has~     never been described. The investigators aim is to correlate the degree of change in IVCCI~     with the set degree of change in intra-thoracic pressure in a heterogeneous population of~     critically ill patients.~   "
185535|NCT01136096|"~     Investigators hypothesized home-based exercise intervention was beneficial to those who have~     had diabetic risk factor for type 2 diabetes mellitus~   "
185547|NCT01135940|"~     This is a prospective, Phase II (hypothesis generating) randomized pilot study investigating~     the efficacy of using Dermabond as a method of final wound closure as compared to the~     standard staple method in children with Neuromuscular Scoliosis undergoing spinal deformity~     correction surgery.~   "
185536|NCT01136083|"~     Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an~     essential process for tumoral growth and metastasis. This process is dependent on the balance~     between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated~     with myostatin overexpression in cancer. Exercise training can depress tumor growth and~     suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and~     some animal studies. The purpose of this study is mainly to investigate the effects of~     exercise training on~        1. circulating VEGF-A~        2. muscle growth and function~        3. Myostatin~   "
185537|NCT01136070|"~     The present study seeks to examine the course of body image, social avoidance and~     psychosocial aspects of depression and anxiety over time in burn patients. Gaining a better~     understanding of the effects of burn injury on body image in burn patients over time could~     help us to better understand the psychosocial sequelae of burns and to identify potential~     interventions which may serve to improve the quality of life in burn patients.~   "
185538|NCT01136057|"~     Treatment options are limited for the treatment of influenza. This study will collect blood~     from people who have been exposed to the influenza virus or who have received a seasonal~     influenza vaccine. The blood plasma will be used in a future clinical trial to treat people~     hospitalized with influenza.~   "
185539|NCT01136044|"~     The purpose of this study is to evaluate the possible harvest of a tensor fasciae latae flap~     based on septocutaneous perforators.This study should further confirm our data from an~     anatomical study concerning location, distribution, diameter and differentiation of the~     perforators.~   "
185540|NCT01136031|"~     -  Usually the combination of fluoropyrimidine with platinum is used as a first line~          chemotherapy (for example, 5-FU+cisplatin, capecitabine+cisplatin, S-1+ cisplatin,~          5-FU+oxaliplatin) in advanced gastric cancer.~        -  After failure with this combination, taxane-based regimen or irinotecan-based regimen is~          usually used. But, as a second-line regimen, the combination of topoisomerase inhibitor~          with taxane has not been fully evaluated until now.~        -  So we designed this phase I/II study to evaluate the efficacy and toxicity of~          second-line chemotherapy with paclitaxel and irinotecan in fluoropyrimidine and~          platinum-pretreated advanced gastric cancer.~   "
185541|NCT01136018|"~     Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal~     area or lower extremities but for relieving acute or chronic pain of low back and lower~     extremities. Recently, there were some reports that there was a difference of the contrast~     flow pattern during lumbar epidural block according to a location of needle tip in the lumbar~     epidural space. Therefore, the investigators hypothesize that there is a difference of~     contrast flow pattern in caudal epidurography when a needle is inserted with intentionally~     lateral direction.~   "
185542|NCT01136005|"~     Objective:~      To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific ≥ grade~     2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and~     the adherence during the 6-week skin treatment period. The adherence to the study creams will~     also be studied.~   "
185543|NCT01135992|"~     This trial is conducted in the United States of America (USA). The aim of this clinical trial~     is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec~     (IDeg) in subjects with type 2 diabetes mellitus.~   "
185544|NCT01135979|"~     The purpose of this study is to investigate what effect a local anesthetic nerve block of the~     arm in patients with end stage renal failure has upon blood flow in the skin of the arm.~   "
185545|NCT01135966|"~     Pulmonary rehabilitation has been emerged as a recommended standard of care for patients with~     chronic lung disease based on a growing body of scientific evidence. A set of evidence-based~     guidelines were published in American College of Chest Physicians (ACCP) and the American~     Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Since then, the~     published literature in pulmonary rehabilitation has increased substantially, and other~     societies have published important statements about pulmonary rehabilitation (eg, the~     American Thoracic Society and the European Respiratory Society).~      In patients with COPD, there is a strong scientific basis for implementing conventional~     resistance training (CRT) in addition to endurance training. Endurance training, such as~     walking, is a key component of pulmonary rehabilitation and improves in exercise tolerance~     and muscular endurance. However, this type of training may not reverse muscle weakness or~     atrophy. For that reason, strength training seems to be the optimum training modality to~     increase muscle mass and strength.~      Recently, Whole-Body-Vibration (WBV) training has been promoted as an alternative for~     resistance training on multigym equipment. In WBV training, the subject stands on a platform~     that generates vertical sinusoidal vibration, during which static and dynamic exercises can~     be performed.~      The present study is conducted to provide an answer on the following question: will a~     resistance training program, such as the whole body vibration, be even effective than a~     conventional resistance training program in patients with COPD.~   "
185546|NCT01135953|"~     tDCS has been shown to be an effective treatment for depression. However, tDCS is a~     relatively new clinical tool and more needs to be understood about its use. This study hopes~     to further the field of knowledge by examining how tDCS should be optimally used. Application~     of tDCS in clinical trials of depression is typically to the prefrontal cortex, but in this~     project, tDCS application will be to the motor cortex as it provides a more ready measure of~     excitability. Excitability will be measured using Transcranial Magnetic Stimulation (TMS) to~     the motor cortex and electromyography (EMG) recordings from peripheral muscles stimulated.~     Using a cross-over three-arm design this study aims to investigate whether daily tDCS~     administered in increasing intensity across sessions leads to greater and lasting effects on~     brain excitability than keeping the intensity at a same dose across the days and whether the~     excitatory effect could be enhanced with D-cycloserine, a medication known to prolong the~     excitatory effects of a single session of tDCS. This in turn will inform on how to optimize~     tDCS for therapeutic applications, e.g treatment of depression. The study hypothesis is that~     5 sessions of tDCS with a dose of D-cycloserine given on the Monday and Thursday sessions~     will result in more sustained effect on motor cortex excitability than 5 sessions of tDCS~     alone. The second hypothesis is that the gradational increases in tDCS intensity over 5~     sessions will result in greater motor cortex excitability than 5 sessions of tDCS where~     intensity is kept constant across sessions.~   "
185549|NCT01135914|"~     To evaluate, specifically within the Canadian medical environment, the efficacy, safety and~     cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus~     laser photocoagulation), or as monotherapy in comparison with the current standard of care~     (laser photocoagulation monotherapy), in patients with visual impairment due to DME.~   "
185550|NCT01135901|"~     This is a development project involving four different municipalities in Central Norway. The~     aim is to identify adults with overweight and with an increased risk of developing diabetes~     mellitus type 2, then to prevent the disease to develop by the means of a behaviour change~     programme. The programme is group based.~   "
185551|NCT01135888|"~     Because of their lack of sweat glands individuals with hypohidrotic ectodermal dysplasia~     (HED) are at particular risk of life-threatening hyperthermia during exercise in a warm~     environment. In this study, the effects of physical exercise are investigated in boys and~     male adolescents with X-chromosomally inherited HED as well as age-matched controls, who~     undergo standardized exertion on a bicycle ergometer at ambient temperatures of 25°C and~     30°C. Body core temperature during and after ergometry, heart rate, performance, and serum~     lactate as a marker of metabolic stress are measured. Subjects with HED are expected to show~     an endangering rise of body temperature in connection with physical exercise. To clarify,~     whether novel cooling devices may reduce the likelihood of overheating, the effects of such~     devices are evaluated at 30°C.~   "
185552|NCT01135875|"~     The purpose of this study is to determine if tumor cells can be detected in the blood of~     patients diagnosed with a brain tumor.~   "
185553|NCT01135862|"~     Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality.~     Although not fully proved, it is commonly accepted that the morbidity and mortality and~     proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more~     injury than smaller ones).~      Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The~     antiaggregate effect may be neutralized by administration of platelets. Thus, potentially,~     patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an~     intracranial bleed.~      In this prospective study, the investigators randomize patients receiving aspirin that have a~     traumatic intracranial bleed to two groups, one - that will receive platelets, and the other~     that will not receive platelets.~      The primary end point of the study is to evaluate the effect of platelet administration of~     the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome~     differences between the two groups.~   "
185554|NCT01135849|"~     We hope to determine the importance of different genes (including B receptors) in~     anthracycline-induced cardiomyopathy. This has important benefits to patients exposed to~     anthracyclines, as this could help determine whether certain individuals have increased~     susceptibility to cardiac injury.~   "
185555|NCT01135836|"~     Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter~     hospitalizations, and less post-operative pain as compared with traditional laparotomies.~     However, there is marked interindividual variability of post-operative shoulder-tip pain~     following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and~     ranges from mild to severe. In some cases, it has been reported to last more than 72 hours~     after surgery.~      The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic~     nerve irritation causes referred pain to C4. Therefore, the investigators should try to~     reduce carbon dioxide retention in the pelvic cavity.~   "
185556|NCT01135823|"~     The primary purpose of the proposed research is to explore methods of obtaining symptom~     assessments from pediatric oncology patients and/or their caregivers in hopes of improving~     the accuracy and thoroughness of these reports. Additionally the researchers hope to simply~     staff efforts in obtaining detailed medical histories from pediatric oncology patients.~   "
185557|NCT01135810|"~     Hypnotic trance and mindfulness meditation have both been shown to have benefits for physical~     health. The current study seeks to determine if there are distinct patterns of brain activity~     that correlate with hypnotic trance, mindfulness meditation or both, and to relate these~     patterns to measurable markers of physical well-being. Precise neuroimaging of heightened~     attentional states will guide future researchers and practitioners toward more effective~     techniques of mind/body control.~   "
185558|NCT01135797|"~     The objective of this study is to collect retrospectively long term safety data in patients~     who have participated in the previous phase I-II trials conducted with the compound.~   "
185559|NCT01135784|"~     The purpose of this study is to study MIGRA-ZEN RELIEF PLUS, an all-natural herbal dietary~     supplement product, with respect to alleviating and/or stopping migraine headache pain~     compared to a placebo when used prophylactically. This study will involve subjects suffering~     from chronic migraine headaches.~   "
185560|NCT01135771|"~     This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement.~     The accuracy of the test device will be determined using plasma samples collected directly~     from Type 1 and Type 2 Diabetics using the OptiScanner. Blood samples will simultaneously be~     collected and measured on YSI 2300 STAT PLUS (YSI) made by YSI Incorporated. These results~     will be compared to the OptiScanner's glucose measurement.~   "
185561|NCT01135758|"~     Targeting the glutamatergic system to treat depression is a new and promising strategy based~     on studies at the molecular, synaptic, and neuronal level but also on results of studies~     conducted in animal models and first clinical studies involving depressed patients.Ketamine~     has been proposed as a novel approach to induce rapid antidepressant response. In this pilot~     project the investigators aim to introduce this novel and promising approach into clinical~     practice. Besides the assessment of clinical efficacy, the investigators will put a special~     emphasis on the assessment of ketamine-associated effects on brain function using fMRI and~     cognitive testing.~   "
185562|NCT01135745|"~     The purpose of the study is to monitor the safety and performance of Reclaim® Deep Brain~     Stimulation (DBS) Therapy in patients with chronic, severe, treatment-resistant Obsessive~     Compulsive Disorder.~   "
185563|NCT01135732|"~     PROTOCOL~      Introduction: The introduction of endoscopic retrograde cholangio-pancreatography (ERCP) and~     endoscopic sphincterotomy (ES) in 1974 has dramatically changed the treatment of biliary and~     pancreatic diseases. ES permits transection of Oddi's sphincter, allowing the endoscopist to~     remove stones and place stents.~      The main indications for ERCP are: 1. Removal of common bile duct stones 2. Dilation of~     benign biliary ducts strictures 3. Stent placement in patients with malignancy 4. Acute~     biliary pancreatitis 5. Removal of stones and dilation of strictures of the main pancreatic~     duct in patients with chronic pancreatitis and 6. Treatment of biliary fistulae after~     surgical operations .~      Complications of ES can be described as early (within one month after ES) and late. Early~     complications have approximately a 10% incidence and include: 1.acute pancreatitis (5,4%)~     2.bleeding (2%) 3.acute cholangitis (1%) 4.acute cholecystitis (0,5%) 5. Perforation and~     others (1,1%). Late complications are mainly the recurrence of choledocholithiasis (2,5%),~     narrowing of the previous ES and recurrent acute cholangitis. Furthermore, there is a debate~     in the literature about late development of cholangiocarcinoma.~      Carcinogenesis after surgical sphincteroplasty and biliary-enteric anastomosis has been~     described. Previous studies have shown late development of cholangiocarcinoma after~     transduodenal sphincteroplasty and biliary-enteric anastomosis for benign disease. The~     incidence is up to 7% in a twenty-year follow up, while in the general population is~     approximately 1/ 100.000 . In addition, Tocchi et al showed that the rate of~     cholangiocarcinoma after transduodenal sphincteroplasty and choledochoduodenal anastomosis is~     up to 5-7% and after other choledochi-enteric anastomoses approximately 1,9%. It seems that~     the ablation of sphincter function causes prolonged pancreatobiliary and duodenobiliary~     reflux. Proteolytic pancreatic enzymes are activated and bacterial intestinal flora colonizes~     the biliary epithelium, causing recurrent inflammation. Chronic inflammatory irritation may~     lead to hyperplasia, dysplasia and atypia of epithelium, ultimately inducing carcinogenesis.~      Eleftheriadis et al, studied changes of the biliary epithelium in patients who underwent~     choledochi-duodenal anastomosis for benign disease, and hyperplasia of the biliary epithelium~     was demonstrated. The same results and atypia of biliary epithelium were reported by Kurumado~     et al, in mice models with choledochi-duodenal anastomosis. Anomalous pancreatobiliary~     junction and choledochal cysts produce the same histologic alterations of the biliary~     epithelium.~      These facts raise a great amount of concern about late development of cancer after ES.~     Bergman et al in a small trial argues that after ES, the function of the biliary sphincter is~     permanently lost. On the other hand, Sugiyama et al demonstrated the reduction of~     pancreatobiliary reflux 1 year after ES. In addition, large population-based studies have~     shown no causal association between ES and cholangiocarcinoma, but with enough limitations in~     study design. In conclusion, the long term cytologic changes of the biliary epithelium after~     ES for benign disease are not well known.~      During ERCP, brush cytology can be performed to evaluate bile duct strictures. The use of~     endoscopic brushing after ES has no reported complications .~      Objective: To evaluate cytologic alterations of the biliary epithelium after previous~     endoscopic sphincterotomy for benign disease.~   "
185564|NCT01135719|"~     Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye~     with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized~     excimer laser.~   "
193244|NCT01034150|"~     Objective: To investigate effects of home-based somatosensory stimulation associated with~     motor training on improvement in performance of the paretic upper extremity in patients in~     the chronic phase after stroke.~   "
185565|NCT01135706|"~     The investigators propose to confirm that normotensive and hypertensive pulmonary arteries~     are fractal, as well as define if the FD correlates to disease severity when compared to~     available data such as six-minute walk and right heart catheterization measurements.~   "
185566|NCT01135693|"~     Section 136 of the Mental Health Act (MHA) 1983 allows the police to detain someone in a~     public place if there are reasons to believe that they may be suffering from a mental~     disorder and to be in need of care or control. For a significant number of psychiatric~     patients, detention under section 136 and accessing psychiatric services via the police~     remains an important, and sometimes the only pathway to care. Approximately 17400 people were~     detained under section 136 of the MHA 1983 during the year 2005-2006 (Independent Police~     Complaints Commission, 2008).~      Despite the large number of patients accessing mental health services via the police, there~     is no research available to identify the service users' perspective of what led them to come~     into contact with police and to identify the reasons for care not being accessed by~     conventional routes. Royal College Psychiatrists (RCP, 2008) and Independent Police~     Complaints Commission (IPCC, 2008) found that there was lack of research into the service~     users' perspective and recommended research into this area.~      The investigators have devised this research project to help themselves and the wider~     research and clinical community understand the service users' perspective of how they came to~     be detained by the police, whether the community services had failed and explore their views~     to understand what can be done to improve the service provisions.~      Fieldhead hospital, Wakefield provides acute inpatient care for psychiatric patients. Those~     who are detained under section 136 of the MHA in Wakefield area are taken to a place of~     safety and following assessment they may be admitted formally or informally to Fieldhead~     hospital for assessment and treatment. Those who are detained under section 136 of MHA and~     subsequently admitted as inpatients to Fieldhead hospital will be included in this study.~   "
185567|NCT01135680|"~     Arm 1:~      Primary Objective:~      • To determine the safety and tolerability of multiple ascending, supratherapeutic doses of~     HPN-100.~      Arm 2:~      Primary Objective:~      • To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid~     [PBA], phenylacetic acid [PAA], and phenylacetylglutamine [PAGN]) on 12-lead~     electrocardiogram (ECG) parameters in healthy male and female subjects with the primary~     endpoint being the time-matched change from baseline in the QT interval corrected for heart~     rate (HR) based on an individual correction method (QTcI).~   "
185568|NCT01135667|"~     All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for~     clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.~      A cut off value has previously been established. Only low-responders with Multiplate values~     above the cut off value are included in the study. The patients are randomized to either~     clopidogrel 150 mg once daily or Prasugrel 10 mg (age > 75 og bodyweight < 60 kg 5 mg)once~     daily for 30 days after the procedure.~      Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed.~      Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified~     antiplatelet therapy.~      Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major~     adverse cardiac events (MACE) at 30 days will be collected and reported but the study size~     does not allow for formal statistical analysis The study ends by the 30 days follow up visit~     and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study~     related)~   "
185569|NCT01135654|"~     The purpose of this study is to determine whether Alcohol Screening, Brief Intervention, and~     Referral to Specialty Chemical Dependency Treatment (as appropriate) by Non-Physicians versus~     Primary Care Providers (versus control group) is more likely to be implemented and more~     effective at reducing unsafe drinking.~   "
185570|NCT01135641|"~     The main objective of the study is to improve the response rate (complete and partial~     remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD)~     and treatment with the combination of ciclosporine, prednisone and Rituximab as first line~     treatment.~   "
185571|NCT01135628|"~     Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden~     of diseases with therapeutical difficulties for its given morbidity and mortality and the~     high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more,~     minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a~     subclinical entity. As so, the investigators propose an auxiliary treatment for the~     management of such patients with minimal hepatic encephalopathy, using a specific diet~     consisting on hyperproteic and fibre-rich foods along with two independent interventions,~     whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate~     of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic~     encephalopathy itself to none hepatic encephalopathy.~   "
185572|NCT01135615|"~     Vascular calcification and endothelial dysfunction (ED) contribute to the development of~     cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a~     non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification~     in CKD patients while the exact mechanism has not been clarified.~      This study was designed to investigate the effect of short-term sevelamer treatment on both~     serum FGF23 levels concentrations and ED seen in CKD patients.~      The researchers investigated the relationship between plasma FGF23 levels and the forearm~     blood flow response to ischemia in the forearm in a sizable series of incident stage 3-4 CKD~     patients.~   "
185573|NCT01135602|"~     12-week, open-label study of topiramate in hospitalized patients with alcoholism~   "
185574|NCT01135589|"~     This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic~     stem cell transplantation. Micafungin is administered until confirmation of neutrophil~     engraftment or treatment failure.~   "
185575|NCT01135576|"~     -  The objective of the study is to know if consumption of an iron fortified fruit juice~          containing micronized iron pyrophosphate, is useful to increase iron status in women~          predisposed to iron deficiency anemia.~        -  A secondary objective is to know if consumption of this iron fortified fruit juice~          modifies bone remodelling.~   "
185576|NCT01135563|"~     This study is a Phase I study using vinblastine and sirolimus in patients with relapsed solid~     tumors including selected brain tumors and lymphoma. The investigators hypothesis is that the~     combination administration of weekly vinblastine and sirolimus is safe.~   "
185577|NCT01135550|"~     The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus~     high dose dexamethasone in the treatment of radiation induced vomiting.~   "
185578|NCT01135537|"~     This study will describe the pharmacokinetic disposition of biologically active rabbit~     anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of~     the conditioning regimen in children undergoing hematopoeitic stem cell transplantation~     (HSCT).~   "
185579|NCT01135524|"~     The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS.~     Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a~     maximum of BTDS 20 to achieve stable pain control.~   "
185581|NCT01135498|"~     This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox~     (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal~     cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day~     1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1).~     Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every~     3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until~     disease progression, and the target sample size is <100 individuals.~   "
185582|NCT01135485|"~     The purpose of this study is to determine whether children and adolescents 8-18 years of age~     with HLHS and related lesions who have undergone stage I palliation during infancy using an~     allograft patch demonstrate continued evidence of HLA antibody formation.~   "
185583|NCT01135472|"~     This dose response study is proposed to explore the extent to which Nexium increases~     endogenous gastrin concentrations and to assess whether Nexium treatment may be useful in the~     setting of islet cell transplantation for type 1 diabetes to expand islet cells in vivo after~     transplant.~   "
185584|NCT01135459|"~     The primary objective of this study is to evaluate the efficacy of a 200-mcg dose of~     CEP-33457 compared with placebo in patients with active systemic lupus erythematosus (SLE) as~     assessed by the proportion of patients achieving a combined clinical response using the SLE~     responder index (SRI) at week 24.~   "
185585|NCT01135446|"~     The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK),~     safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in~     healthy subjects.~   "
185586|NCT01135433|"~     This study is to evaluate the efficacy and safety after concomitant administration of ASP1941~     and metformin in patients with diabetes mellitus.~   "
185587|NCT01135420|"~     This research program will improve the care and treatment outcomes of dually diagnosed~     veterans who receive inpatient psychiatry care, and decrease their use of VA inpatient mental~     health services. It will increase the use of substance abuse outpatient care and 12-step~     groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.~   "
185588|NCT01135407|"~     Parkinson's disease (PD), which is generally considered to be a motor disorder, is now known~     to be accompanied in many instances by a variety of cognitive defects. This can be explained~     considering that PD is a neurodegenerative and progressive disorder of the basal ganglia~     system, which works modulating not only motor, but also cognitive and emotional behaviours.~      Concerning this, some studies suggest that non-demented PD patients may suffer from a~     voluntary selective visual attention orienting deficit, showing a reduced skill in focusing~     upon one target, and may be easily distracted from irrelevant but salient stimuli, with a~     consequent negative impact on their physical health, social interactions and quality of life.~      Up to now, the evidence of the role of the basal-ganglia system in modulating visual~     attention functions is poor and indirect and the effects of dopaminergic and subthalamic~     nucleus (STN) stimulation (two usual and effective treatments in PD) on attention~     performances are controversial.~      The main objectives of the project are: 1) to assess the visual selective attention as well~     as the distractibility in PD patients; 2) to study the effects of patient's usual~     antiparkinsonian treatments, that is dopaminergic and STN stimulation, on visual attention~     performances.~      Secondly, from a clinical and neurophysiologic point of view, the investigators want to study~     the respective role of the dopaminergic pathways and the sensorimotor and associative/limbic~     cortico-basal ganglia loops passing across the STN in the visual attention performances.~      To precisely answer the objectives of the protocol, the investigators will record the~     performances of participants during the administration of 3 computerized tests, which are~     suitable to study visual attention, decision making and motor performances.~      The investigators will compare the performances on the computerized tests of two groups of PD~     patients, one evaluated in different sets of electrical (without stimulation, or selective~     stimulation of the sensorimotor or associative/limbic part of the STN) stimulation, the other~     in different conditions of medication (with or without dopaminergic treatment) with those of~     a group of healthy subjects.~   "
185589|NCT01135394|"~     The purpose of this study is to determine predictors of response to pioglitazone, an~     anti-diabetic medication. The investigators know from randomized clinical trials that some~     30% of patients do not respond to this type of medication. There is presently no way to~     identify this group of patients leading to unnecessary drug exposure and medication costs.~   "
185590|NCT01135381|"~     For complex medical patients, the transition from hospital to home-based care is a vulnerable~     period, placing the patient at high risk for adverse events. Using a Care Transition~     conceptual model, the investigators propose developing and evaluating, through a randomized~     controlled trial, e-Coach, an Interactive-Voice-Response-supported (IVR) Care Transition~     coaching intervention, focused initially on patients hospitalized with heart failure or~     obstructive lung disease. This trial will test the primary hypothesis that the proportion of~     patients with one or more re-hospitalizations during a 90-day post-discharge follow-up period~     will be less in an IVRsupported care transition intervention (e-Coach) compared to a usual~     care comparison group.~   "
185591|NCT01135368|"~     The purpose of this study is to measure the safety, efficacy and quality of life of~     lansoprazole in patients with reflux disease over a five year period.~   "
185592|NCT01135355|"~     The aim of our study is to determine whether a clinically relevant laboratory measurement (of~     seven specific immunologic biochemicals in the blood) can identify which bone marrow~     transplant recipients are likely to progress to respiratory failure. Our ultimate goal is to~     devise a comprehensive and inclusive laboratory test that is effective at determining who is~     likely to go on to respiratory failure, in order to facilitate early medical intervention.~   "
185593|NCT01135342|"~     The goal is to determine if improved sleep will increase/enhance weight loss among overweight~     adults with insomnia.~   "
185594|NCT01135329|"~     This research is being done to learn more about reduced-intensity bone marrow transplantation~     (BMT), also known as a mini transplant for patients with blood cancers, using bone marrow~     from a relative.~      The main goal of the study is to determine how quickly the donor's bone marrow takes in~     your body. Other goals include describing how many people accept the bone marrow and how~     quickly the blood counts come up; describing Graft-versus-host disease (GVHD) and other~     complications; and describing how many people survive without progressive cancer and survive~     overall~   "
185595|NCT01135316|"~     Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15~     sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and~     followed for up to 24 months.~   "
185698|NCT01133977|"~     Primary:~        -  Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of~          lenvatinib administered in combination with dacarbazine.~        -  Phase II: To evaluate the safety and tolerability of lenvatinib administered in~          combination with dacarbazine, compared with dacarbazine alone.~      Secondary:~      -Phase II: To make a preliminary assessment of the efficacy of lenvatinib administered in~     combination with dacarbazine, compared with dacarbazine alone.~   "
185596|NCT01135303|"~     The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in~     adults is now well documented as well as its cardiovascular repercussions. Previous studies~     showed a conclusive link between SAHS and severe cardiovascular diseases such as~     hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health~     issue in adults.~      In this context, early detection of such a disease is crucial if the management is tailored~     to the patient, the practitioner's choice of therapy moving towards continuous positive~     airway pressure (CPAP) or mandibular advancement device. The detection is based on full~     nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold~     standard but it is a time consuming and costly examination. Polygraphic recording is a test~     that allows simplified the diagnosis of severe patients, but may not be sufficient for mild~     form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation~     of a technique for identifying patients most at risk to either limit the number of~     polysomnographic examination is requested.~   "
185597|NCT01135290|"~     This study tests two different approaches to the resolution of facial skin resurfacing.~   "
185598|NCT01135277|"~     Patients in the ICU are already predisposed to nosocomial infections, which are both costly~     and potentially life threatening, and it appears that the immune paralysis of sepsis may put~     these patients at greater risk for secondary infections, though this has not been proven~     conclusively. One measure of this sepsis-induced immune suppression is monocyte deactivation.~     The investigators hypothesize that, as a cornerstone of the monocytic innate immune response~     to infection, the inflammasome is critical to monocyte function during sepsis.~   "
185599|NCT01135264|"~     In the proposed two-arm randomized controlled trial, 200 patients meeting DSM-IV criteria for~     PG will be randomized to 12 sessions of Cognitive-Motivational Behavior Therapy (CMBT) or to~     Cognitive Behavior Therapy (CBT).~   "
185600|NCT01135251|"~     One hundred consenting AIDS patients suffering from treatment induced painful neuropathy will~     be blindly randomize to Active and Placebo groups (ratio A/P = 3/2 and will receive~     increasing oral doses of dimiracetam starting from 400 mg b.i.d. and doubling the dose every~     two weeks until a maximum of 1600 mg b.i.d. Escalation to the the higher dose is allowed only~     if the previous dose did not cause tolerability problems. The highest reached dose will be~     maintained for a total of 8 week treatment. Patients must have a self evaluated pain of at~     least 4 on a 10 cm visual analog scale (VAS). Primary end point of the study will be the~     number of Adverse Events (AEs) reported in the placebo versus the active group. Preliminary~     evidence of efficacy will be sought by comparing active and placebo group as to the intensity~     of their pain at study onset and at study end. The pain will be evaluated by the VAS the~     Total Symptoms Score and the Clinical Global Impression~   "
185601|NCT01135238|"~     The adrenal glands are one of the most common organs involved in metastatic disease.~     Metastases are the second most common type of adrenal mass, second only to adenomas. It is a~     frequent finding during autopsy with a reported rate as high as 27% in patients with known~     primary malignancy. Although several studies have found an increased survival in patients who~     undergo resection of solitary adrenal metastases the indications for adrenalectomy in cases~     of metastatic adrenal tumor remain controversial. Collinson et al reported an increased~     survival in patients with melanoma. Median survival was 16 months for patients who underwent~     adrenalectomy compared to 5 months for patients with documented adrenal metastases treated~     non surgically.~      The aim of this study is to compare retrospectively in case and control study, performing~     adrenalectomy, open or laparoscopic, versus supportive treatment for patients with solitary~     adrenal gland metastases. The investigators will review charts of patients between January~     1994 and November 2009 who had adrenal gland metastases. The variables the inevstigators will~     compare are mortality, morbidity, primary tumour sites, histological cell type, age, tumour~     size, presence of synchronous metastases, mean time from diagnosis of primary tumor to~     treatment of adrenal metastases, indication for adrenalectomy, partial versus total~     adrenalectomy, suspected versus confirmed metastatic disease.~   "
185602|NCT01135225|"~     The purpose of the EVOLVE Trial is to assess the safety and performance of the~     everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of~     up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety~     and performance of two different drug release rate formulations of the Evolution Stent will~     be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.~   "
185603|NCT01135212|"~     The purpose of this clinical study is to evaluate and compare the efficacy and safety of~     Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate~     hypertension.~   "
185604|NCT01135199|"~     The purpose of this study is to determine the safety and efficacy of pomalidomide over a 12~     week duration in the treatment of chronic cough in patients with IPF as measured by a Cough~     Symptom Diary, Visual Analogue Scale for Cough Severity, Leicester Cough Questionnaire, St.~     George Respiratory Questionnaire, Cough-Specific Quality-of-Life Questionnaire, and adverse~     event reporting. There will be an option open to participants, who respond to treatment by~     meeting pre-determined criteria, to remain in the study for an additional 9 months or for a~     total of 54 weeks.~   "
185605|NCT01135186|"~     Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with~     Diabetic Gastroparesis (KIGA-DG)~   "
185606|NCT01135173|"~     The study is a two-group parallel arm randomized clinical trial, to be conducted at the~     Syrian Center for Tobacco Studies (SCTS) in Aleppo, Syria.~   "
185607|NCT01135160|"~     The regime in the aftercare after total hip and knee arthroplasty(THA/TKA) differs a lot~     between orthopedic surgeons concerning weight bearing. The type of implant and the way of~     implants' anchoring are considered.~      In the literature there is no data so far about the way patient take care of the recommended~     weight bearing during the first 6 weeks after THA and TKA.~      Over a one year period starting August 2010 all patients undergoing TKA or THA at the~     investigators institution will have a technical device in their shoes (sole) to measure the~     load in each step they do in these shoes during the first 6 weeks. Patients are asked to fill~     out a standardised pain protocol every day (VAS) and document need of pain medication. The~     investigators recommend 20kg of weight on the operated leg for 6 weeks and full weight~     bearing at the end of week six.~      The investigators believe that patients will adjust weight bearing to their level of pain and~     not to their surgeons recommendations.~   "
185609|NCT01135134|"~     This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate~     (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of~     age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days~     at minimum and eligibility for inclusion in this study will be assessed. Following the~     observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week~     double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2~     weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse~     events (AEs), will be evaluated. A 30-day follow-up visit will take place after the~     completion (or discontinuation) of the 2-week treatment period, to confirm presence or~     absence of serious adverse events (SAEs) and trial procedure-related AEs.~   "
185610|NCT01135121|"~     The purpose of this study is to determine whether the diaphragm develops contractile fatigue~     during a weaning trial and if this is associated with weaning failure.~   "
185611|NCT01135108|"~     The purpose of this study is to determine whether KAI-1678 is effective in the treatment of~     pain associated with spinal cord injury.~   "
185612|NCT01135095|"~     A prospective single clinical trial to validate the use of a low-dose (~5mSv) Tc-99m protocol~     with a high-efficiency cardiac dedicated camera (Dynamic Single Photon Emission Computed~     Tomgraphy; D-SPECT) to detect myocardial perfusion abnormalities during myocardial perfusion~     imaging.~   "
185613|NCT01135082|"~     The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent~     pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors~     for protective antibody responses after receiving the vaccine.~   "
185614|NCT01135069|"~     The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear~     Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.~   "
185615|NCT01135056|"~     The primary objective of this study is to assess the efficacy of SIRT as compared with~     Sorafenib in patients with locally advanced liver cancer in terms of overall survival (OS).~      The Study null hypothesis is, there is no difference in overall survival between patients~     receiving SIRT and those receiving Sorafenib therapy.~   "
185616|NCT01135043|"~     simple verbal intervention with figure of lung and upper respiratory tract will be helpful to~     adequately collecting sputum.~      and in the acceptable specimen based on Gram stain, positivity for AFB stain and culture rate~     will be higher.~   "
185617|NCT01135030|"~     The purpose of this study is to look at two different referencing systems for total knee~     replacement surgery. In anterior referencing system, referencing cuts are made from the front~     surface of the femur. This allows for a more exact cut. The anterior referencing system is~     more difficult for the surgeon to use. This may increase surgery time. Posterior referencing,~     on the other hand, references cuts from the back of the femur. The posterior referencing~     system is quick and easy for the surgeon to use. Posterior referencing may lead to notching~     of the femur. The risk of notching is very low and may not affect your results. This is a~     study that has never been done before. Dr. Heekin uses both referencing systems in his~     practice. He would like to determine which knee referencing system allows for greater knee~     flexion after surgery. Knee flexion correlates with function and the ability to return to~     everyday activities. For example, getting up from a chair, going up and down stairs,~     stooping, and kneeling.~   "
185618|NCT01135017|"~     Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF)~     burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a~     permanent pacemaker.~      Secondary objectives were to evaluate:~        -  the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during~          AF;~        -  the effects of dronedarone on subject-perceived AF burden and symptom severity as~          reported by subjects using the Atrial Fibrillation Severity Scale (AFSS);~        -  the incidence of electrical cardioversion (or overdrive pacing) during treatment;~        -  the safety of dronedarone.~   "
185619|NCT01135004|"~     Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The~     estimated recurrence rate is 23-50% after the first episode and increases to 60% after the~     second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally,~     rupture of the emphysematous change or blebs in the apex of the lung is considered as the~     cause of pneumothorax. The main purpose of this study is to investigate the molecular~     pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy~     patients.~   "
185620|NCT01134991|"~     Acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. It is a~     syndrome of undetermined etiology characterized by both vascular and papulopustular~     components involving the face and occasionally the neck and upper trunk.~      This is a pilot phase II study to evaluate the tolerability and safety and to monitor the~     clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.~   "
185621|NCT01134978|"~     The overall goal of this study is to gain insight into the neural mechanisms of learning~     multiple tasks. By examination of cognitive and behavioral output during the performance and~     learning of several computer maze tasks, and through a detailed examination of the neural~     activity obtained from functional near-infrared (fNIR) and electroencephalography (EEG), it~     may be possible to gain insight into the impact of the amount of practice and the~     organization of practice has on learning fine motor skills. This insight may provide~     direction as to how to better develop instructional and rehabilitation protocols in addition~     to clinical interventions to facilitate recovery of function, relearning and transfer of~     cognitive and fine motor skills based upon neural responses to physical practice.~   "
185622|NCT01134965|"~     The aim of this trial is to investigate the effect of multiple doses of flibanserin on the~     single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a~     narrow therapeutic index drug for which a large number of relevant drug-drug interactions are~     known. Flibanserin is now under evaluation in postmenopausal women which increases the~     likelihood that flibanserin and digoxin will be administered together in the clinical~     setting.~   "
185699|NCT01133964|"~     The aim of this study is to examine the effect of dairy proteins (whey and casein) on~     postprandial appetite regulation and energy expenditure.~   "
185930|NCT01130935|"~     This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in~     subjects and evaluate with which treatment regimen and on which indications acid suppression~     with isomeric proton pump inhibitor is used in routine clinical practice in Albania.~   "
185623|NCT01134952|"~     Different immunosuppressive drugs used in transplantation may reduce the body's defences~     against infection differently. It is known that patients with Hepatitis C virus, known as~     HCV, who switched from azathioprine to mycophenolate mofetil experienced an increase in viral~     load. Despite this, mycophenolate mofetil is used because it prevents rejection more reliably~     than azathioprine. Sirolimus is an another immunosuppressive agent that reliably prevents~     rejection and may have antiviral activity. This study is designed to see if the viral load of~     HCV and other viruses is reduced by switching from mycophenolate to sirolimus.~   "
185624|NCT01134939|"~     The question that prompted this study is the extent to which results from clinical trials can~     be translated into everyday practice (external validity). First and foremost are questions~     about tolerability and the efficacy of an antiretroviral combination treatment with Viramune~     and other antiretroviral partners. In particular, adverse events will be recorded depending~     on gender and the therapeutic effect will be monitored via the course of viral load and~     improvement of the immune system, based on the CD4 cell count.~   "
185625|NCT01134926|"~     The aim of the study is to find out whether conservative treatment - expectant management or~     medical therapy using misoprostol is beneficial in the case of uterine residua, and which~     treatment is better.~   "
185626|NCT01134913|"~     This is a prospective clinical study designed to procure blood samples from patients who~     present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).~      Subjects enrolled in this study will sign and informed consent and have 4 blood samples drawn~     at different time points during their emergency department visit. In addition, data will be~     collected about the patient's health history, hospital procedures, and final diagnosis. The~     enrolling center will also contact the patients at 30-days, 3 months and 6 months to inquire~     about their condition and survival.~      Blood samples collected in this study will be sent to the sponsor organization for long-term~     storage and analysis in the future for novel blood markers as they become available. No~     genetic testing will be conducted on these samples.~   "
185627|NCT01134900|"~     The utilization of clinical decision support (CDS) is increasing among healthcare facilities~     which have implemented computerized physician order entry or electronic medical records.~     Formal prospective evaluation of CDS implementations occurs rarely, and misuse or flaws in~     system design are often unrecognized. Retrospective review can identify failures but is too~     late to make critical corrections or initiate redesign efforts. A real-time surveillance~     dashboard for high-alert medications integrates externalized CDS interactions with relevant~     medication ordering, administration, and therapeutic monitoring data. The surveillance view~     of the dashboard displays all currently admitted, eligible patients and provides brief~     demographics with triggering order, laboratory, and CDS failure data to allow prioritization~     of high-risk scenarios. The patient detail view displays a detailed timeline of orders, order~     administrations, laboratory values, and CDS interactions for an individual patient and allows~     users to understand provider actions and patient condition changes occurring in conjunction~     with CDS failures. Clinical pharmacists' use of the dashboard for patient monitoring and~     intervention aims to increase the rate and timeliness of intercepted medication errors~     compared to CPOE-based CDS in the setting of acute kidney injury, which affects patients at~     various points across all hospital units and services and has numerous opportunities for~     intervention.~   "
185628|NCT01134887|"~     This randomized control study tested the feasibility of two communication enhancement~     interventions: one with veterans who had a stroke and demonstrated poorly controlled~     hypertension; the other with VA primary care providers who provided routine outpatient~     medical care to these veterans. This study intervened with both members of the~     provider-patient dyad in an attempt to improve the self-management of hypertension by~     improving communication during visits to the VA outpatient clinic, specifically by enabling~     veterans to communicate their questions and concerns about chronic disease self-management to~     their providers more effectively, and to help providers improve their ability to communicate~     more effectively with this population of veterans.~   "
185629|NCT01134874|"~     The primary aim of this study is to compare the changes in body weight between a~     technology-based system, an in-person behavioral weight loss intervention, and a combination~     of both during a 12 month behavioral weight loss intervention in adults. Sedentary, healthy~     overweight and obese adults will be recruited to participate. Assessments will be conducted~     at 0, 6, and 12 months. This is a randomized trial in which participants will be randomized~     to one of three groups: standard behavioral weight loss (SBWL), standard behavioral weight~     loss plus technology (SBWL+TECH), and technology alone alone (TECH).~   "
185630|NCT01134861|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and combining chemotherapy with~     radiation therapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of various schedules of~     radiation therapy and combination chemotherapy using vinblastine and cisplatin or cisplatin~     and etoposide in treating patients with stage II or stage III non-small cell lung cancer that~     cannot be removed surgically.~   "
185631|NCT01134848|"~     The sphincter of Oddi is a circular band of muscle which controls the flow of pancreatic~     juices and bile into the small intestine. Abnormal function of the Sphincter of Oddi, known~     as Sphincter of Oddi dysfunction (SOD), can lead to recurrent episodes of abdominal pain.~     Making a diagnosis of SOD is difficult and is currently achieved using an invasive pressure~     test. This pressure test is associated with some adverse effects including inflammation of~     the pancreas gland. We are investigating an alternative test in which medication is given to~     provoke spasm of the sphincter. Following provocation, blood can be sampled to detect changes~     in blood composition and changes in sphincter anatomy can be evaluated using specialized~     imaging techniques.~      Our aim is to study and compare the effects of two provocation medications~     (morphine-prostigmine and secretin) on biliary and pancreatic ductal anatomy, using dynamic~     serial MRCP in healthy volunteers.~      Our hypothesis is that morphine-neostigmine provocation results in greater changes in biliary~     and pancreatic ductal anatomy when assessed using dynamic serial MRCP.~   "
185632|NCT01134835|"~     To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the~     treatment of asthma.~   "
185633|NCT01134822|"~     The overall aim of this study is to develop a test that predicts the prognosis of IPF~     (Idiopathic Pulmonary Fibrosis) and which could be used to determine whether new treatments~     for IPF are likely to work.~   "
185634|NCT01134809|"~     Background: Skeletal muscle wasting or decrease in muscle mass occurs as a result of~     alteration in the body's mechanisms to make or break muscle protein. In animal models, the~     pathway termed as 'ubiquitin-proteasome pathway' (UPP) is primarily responsible for the~     regulation of skeletal muscle protein loss in wasting conditions and during~     infection(sepsis). Skeletal muscle wasting is noticed in patients having major surgery due to~     the inflammatory reaction triggered by special group of proteins called cytokines~     (inflammatory proteins), resulting in reduced muscle strength, impaired capacity to fight~     infections, change in bowel function, increased clinical complications and prolonged~     recovery. Major surgery also leads to decreased sensitivity to hormone known as insulin,~     resulting in 'diabeteslike'state.~      We hypothesize that susceptibility of patients undergoing major abdominal surgery, to~     skeletal muscle wasting and insulin resistance, is determined by stress response to surgery~     over time, leading to changes in the pathways that make or break muscle protein, namely the~     Akt/Foxo signalling and UPP. Therefore, the aim of this study is to establish the underlying~     mechanisms of skeletal muscle wasting and insulin resistance in patients undergoing major~     abdominal surgery.~   "
185635|NCT01134796|"~     Assessment of a custom made grasp device in the rehabilitation of stroke victims.~   "
185636|NCT01134783|"~     Examine the effectiveness of a weight gain prevention intervention to positively affect body~     mass index in 2-year college students~   "
185637|NCT01134770|"~     The purpose of the study is to understand the biology and behavior of early mother-infant~     attachment, and to investigate how it may be affected by prenatal substance exposures. The~     investigators are interested in how drugs such as cocaine, alcohol, marijuana and cigarette~     smoking affect both mother and baby.~   "
185638|NCT01134757|"~     The present study is aimed to evaluate a bronchial allergen challenge with house dust mite~     and alternaria. Firstly, the years 2005, 2006, 2007, 2008 and 2009 will be retrospectively~     reviewed. Secondly, in 2010-2013, in the prospective part of the study the patients will~     undergo the bronchial allergen challenge to examine safety of the bronchial allergen~     challenge and change of allergen specific bronchial hyperreactivity before and after allergen~     specific immunotherapy.~   "
185639|NCT01134744|"~     The purpose of this study is to identify the clinical criteria for requesting a chest x-ray~     in a patient with blunt trauma and its findings such as clinical signs with a high~     sensitivity could be used in a larger study to codify the final criteria.~   "
185640|NCT01134731|"~     The study aims to use a combined clinical and translational approach to identify an efficient~     pharmacotherapy for the acute management of suicidality and the epigenetic regulation~     associated with the treatment.The primary objective is a clinical trial to compare the~     efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of~     care antidepressants in the acute management of suicidality in depressed subjects.~      Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still~     underway.~   "
185641|NCT01134718|"~     The purpose of this study is to compare in healthy volunteers levels of TMC435 in the blood~     circulation after intake of 2 new capsule formulations with the level of TMC435 in the blood~     circulation after intake of the capsule formulation used in the Phase IIb studies.~   "
185642|NCT01134705|"~     The purpose of the study is to assess the efficacy and safety of an investigational nasal~     aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.~   "
185643|NCT01134692|"~     Chronic peripheral and splanchnic vasodilatation are the hallmark hemodynamic abnormality in~     cirrhosis and contribute to the pathogenesis of portal hypertension.~      Alterations in intestinal motility and bacterial overgrowth in gut may predispose to the~     development of bacteraemia and endotoxaemia in cirrhotic patients which play a role in the~     hyperdynamic circulatory syndrome of cirrhosis. Probiotic therapy is aimed at changing the~     make-up of the indigenous microflora by administering specific strains of non-pathogenic and~     potentially beneficial microflora. In this study, the investigators hypothesize that a~     modification in the composition of the endogenous digestive microflora by oral~     bacteriotherapy with high potency probiotic preparations could be a safe way to regulate the~     portal pressure.~      As there is a relative paucity in effective pharmacological treatment for portal~     hypertension, these novel and innovative therapy might provide important alternative or~     adjunct therapy to beta blockers in the clinical management of patients with portal~     hypertension.~      Aims and objectives~      To study in patients with cirrhosis and large varices whether probiotics and/or norfloxacin~     given for 2 months :~        1. achieve a reduction in HVPG~        2. alter the endotoxin and cytokine levels, and improve systemic inflammatory responses~        3. well tolerated.~      Inclusion criteria:~      Consecutive patients of cirrhosis with portal hypertension who fulfill the following~     criteria:~        1. Diagnosed cases of cirrhosis (by clinical, biochemical and radiological criteria with or~          without liver biopsy)~        2. No history of upper GI bleeding in the past~        3. Endoscopically documented large esophageal varices~      Exclusion criteria~        1. history of gastrointestinal bleeding~        2. patients who have received beta blockers for portal hypertension in the past 6 weeks.~        3. hepatic encephalopathy~        4. ongoing bacterial infection,~        5. Spontaneous bacterial peritonitis~        6. active alcoholism or illicit drug abuse~        7. alcoholic hepatitis~        8. Treatment with antibiotics in the preceding 2 weeks.~        9. presence of hepatocellular carcinoma,~       10. portal vein thrombosis~       11. serum creatinine>1.5 mg/dL,~       12. treatment with vasoactive drugs in the past 6 weeks,~       13. history of arterial hypertension, congestive heart failure or arterial occlusive~          disease, and~       14. Refusal to participate.~       15. Active smokers.~      Study plan:~      Ethical approval will be obtained prior to study initiation. Patients presenting to~     Department of Gastroenterology, GB Pant Hospital will be recruited in the study. Patients~     will be evaluated regarding the eligibility for the study. After being found eligible for the~     study, if the patient agrees to participate in the study, a signed informed consent will be~     obtained. Baseline HVPG will be measured in all patients and then they will be randomized~     into 3 groups:.~        1. Group 1: Beta blockers + placebo~        2. Group 2: Beta blockers + Norfloxacin (400mg BD)~        3. Group 3: Beta blockers + probiotics. (one sachet of VSL#3 BD)~      30 patients will be enrolled into each group. The treatment will be continued for 2 months.~      The study design is a randomized double-blinded placebo controlled trial.~      Once patients have been enrolled, they will undergo baseline investigations. Blood will be~     drawn from both peripheral and hepatic veins and sent for routine parameters,~     pro-inflammatory cytokines (IL-1b, IL-6, IL-10, TNF-α, endotoxins, NO2 and NO3 levels, PRA,~     BNP). Samples will be stored at -70 ºC. Baseline vitals will be recorded.~      Patients will be called at the end of 1 month for assessment of compliance and then at the~     end of the study (2 months) to repeat the HVPG and the same parameters as at the time of~     enrollment~      End Points:~        1. Primary~           a. Change in HVPG levels as compared with baseline, to define responder (≥20% reduction~          in HVPG or ≤ 12 mm Hg).~        2. Secondary~             1. Change in digestive flora~             2. Reduction in serum and hepatic endotoxin and cytokine levels~             3. Assessment of improvement in the renal parameters and Systemic inflammatory~               response syndrome~             4. Improvement in the markers of oxidative injury~             5. Adverse effects~   "
185644|NCT01134679|"~     The purpose of this study is to test the impact of a multidisciplinary approach to improve~     the adhesion and persistence to Clopidogrel therapy. A simple and inexpensive therapy~     management involving a tighter monitoring of patients by nurses and pharmacists will improve~     the persistence and adhesion to Clopidogrel and Aspirin after the implantation of~     drug-eluting stents.~   "
185645|NCT01134666|"~     This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating~     FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type~     metastatic CRC.~   "
185646|NCT01134653|"~     Acute ankle sprain is one of the most common musculoskeletal injuries, accounting for an~     estimated 2 million injuries per year and 20% of all sports injuries in the United States.~     Ankle sprains can lead to prolonged periods of pain, difficulty with mobility, and lost work~     or play time. Current best practice guidelines for treatment of an acute ankle sprain are~     protection, rest, ice, compression and elevation (PRICE). However recent systematic reviews~     for ankle sprains call into question this treatment. Two critical components; immobilization~     and ice, have little or no evidence of efficacy for ankle sprain. Interestingly, mobilization~     appears to be more effective at reducing the pain, swelling and stiffness of musculoskeletal~     injuries including ankle sprains. Historically the limitation to early mobilization has been~     pain. Recently developed stretch bands have been introduced to the therapy market as a tool~     that allows pain-free active and resisted ankle movement after acute ankle sprain.~      The investigators propose a double blind randomized controlled study to compare 2 ankle~     sprain treatments on their ability to speed recovery and reduce morbidities such as pain,~     swelling and weakness.~   "
185647|NCT01134640|"~     A post marketing surveillance, prospective study to collect safety information from 250~     subjects with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type metastatic~     colorectal cancer treated with Erbitux as final evaluable cases.~   "
185648|NCT01134627|"~     This is a multicentric, double-blind, placebo-controlled, randomized, parallel group study to~     estimate the effect of minocycline as add-on to interferon beta-1a (IFN beta-1a) in subjects~     with relapsing-remitting multiple sclerosis (RRMS).~   "
185649|NCT01134614|"~     This randomized phase II trial is studying how well giving ipilimumab with or without~     sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that~     cannot be removed by surgery. Ipilimumab works by activating the patient's immune system to~     fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of~     immune cells found in bone marrow or peripheral blood and may help the immune system recover~     from the side effects of treatment. It is not yet known whether giving ipilimumab together~     with sargramostim is more effective than ipilimumab alone in treating melanoma.~   "
185742|NCT01133405|"~     This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of~     LY2886721 single doses, how the body handles the drug, and the drug's effect on the body.~   "
185650|NCT01134601|"~     Background:~      - The investigational anti-cancer drug AZD6244 prevents a protein found in rectal cancer from~     working properly, which may slow tumor growth and allow radiation and chemotherapy treatments~     to destroy more cancer cells. Researchers are interested in determining whether AZD6244 can~     be used to improve treatment outcomes in individuals who have rectal cancer that has spread~     outside the rectum into the surrounding pelvis.~      Objectives:~      - To determine safe and effective doses of AZD6244, along with radiation and chemotherapy, to~     treat rectal cancer.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with rectal cancer that has~     spread outside the inner wall of the rectum or into lymph nodes in the pelvis.~      Design:~        -  Eligible participants will be screened with a physical examination, blood and tumor~          samples, and imaging studies.~        -  Participants will receive AZD6244 twice a day by mouth for 1 full week (7 days) before~          starting radiation and chemotherapy and every week thereafter until the end of the~          radiation and chemotherapy treatment.~        -  Participants will have radiation therapy daily, 5 days per week, for approximately 6~          weeks.~        -  Participants will receive chemotherapy (capecitabine) twice daily, 5 days per week, for~          approximately 6 weeks.~        -  Approximately 4 to 8 weeks after completing the AZD6244, radiation, and chemotherapy~          treatment, participants may have surgery to remove any tumors and affected lymph nodes.~          This surgery is not part of the treatment delivered on this protocol.~        -  Participants will have a follow-up exam 3 weeks after the end of treatment, every 3~          months for the first year, and then in the second and third year after the end of~          treatment. These visits will involve a full medical examination and imaging studies.~   "
185651|NCT01134588|"~     The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ~     12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize~     that the percentage of completely filled questionnaires will be higher in the touch-screen~     version.~   "
185652|NCT01134575|"~     The goal of this clinical research study is to learn if CMC-544 given alone, and possibly~     given in combination with rituximab, can help to control the disease in patients with ALL.~     The safety of the study drug(s) will also be studied.~   "
185653|NCT01134562|"~     The purpose of this study is to characterize the safety and tolerability of single rising~     doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.~   "
185654|NCT01134549|"~     The purpose of this study is to characterize the safety and tolerability of etelcalcetide in~     healthy young males.~   "
185655|NCT01134536|"~     The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and~     tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and~     adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical~     pain.~   "
185656|NCT01134523|"~     To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast~     cancer patients with positive lymph nodes~   "
185657|NCT01134510|"~     Organ transplantation offers the only hope for a normal life for patients with end-stage~     renal disease on dialysis (ESRD). For the highly-sensitized patient, patients with antibodies~     to human leukocyte antigens (HLA), transplantation is extremely difficult or impossible since~     pre-formed antibodies will cause severe rejection and loss of transplanted organs.~     Approximately 30% of the transplant list in the U.S. is considered sensitized (have~     detectable antibodies to HLA antigens). These anti-HLA (anti-Human Leukocyte Antigen~     antibodies) pose a significant barrier to transplantation that has recently been successfully~     addressed using desensitization therapies with IVIG, rituximab and/or plasmapheresis (PE).~     Despite the success of these therapies, post-transplant antibody mediated rejection (AMR) and~     chronic Antibody Mediated Rejection (CAMR) remain significant problems. Recent data suggests~     that addition of Berinert (C1 Inhibitor) to post-transplant treatment regimen may~     significantly reduce incidence of Antibody Mediation Rejection.~      Twenty highly-sensitized patients who have undergone desensitization treatment and are~     awaiting kidney transplant will be enrolled in the study. Once transplanted these patients~     will be started on the standard of care post-transplant immunosuppressive protocol. In~     addition patients will receive Berinert 20 units/ kg daily x 3 days, then twice weekly x 3~     weeks. At the end of Berinert treatment a kidney biopsy will be performed. Subjects will be~     followed for 6 months to assess safety and efficacy of the study protocol.~   "
185658|NCT01134497|"~     In this randomised Phase II trial all patients will receive carboplatin, with half randomly~     selected to receive ZD4054. The other half to also receive a dummy pill or placebo, this is~     so that we can accurately assess how much extra benefit ZD4054 may give. The trial will~     recruit 132 patients with metastatic breast cancer from across the UK and assess whether~     adding ZD4054 to carboplatin delays progression of their disease. It will also show whether~     the side effects of adding ZD4054 to carboplatin chemotherapy are acceptable.~      Because ZD4054 has not previously been given with carboplatin to this population, in Stage 1~     of the study 6 patients will receive ZD4054 with carboplatin. If there are no untoward side~     effects with carboplatin and ZD4054 then the trial will proceed to Stage 2 and a further 126~     patients will be randomised to receive carboplatin with either ZD4054 or the placebo; neither~     the patient nor their doctor will know whether she is receiving ZD4054 or placebo.~   "
185659|NCT01134484|"~     Thalidomide-Dexamethasone (TD) is a standard induction therapy for Multiple Myeloma (MM). The~     present study is designed to compare TD with VELCADE-Thalidomide-Dexamethasone (VTD) as~     induction therapy in preparation for, and as consolidation after, melphalan-based double~     autologous stem cell transplantation for previously untreated patients aged ≤65 years with~     symptomatic MM. Primary study endpoint is the rate of complete response (CR) plus~     near-complete response (nCR) to induction treatment. Secondary endpoints include the rate of~     CR plus nCR to double transplantation and subsequent consolidation therapy, time to~     progression (TTP), progression-free survival (PFS),overall survival (OS) and toxicity profile~     of both VTD and TD.~   "
185660|NCT01134471|"~     The purpose of this study is to compare 2 different hemostatic agents (Bonewax and Ostene)to~     a control group with regards to bleeding, bone healing, pain and infection in a patient group~     all undergoing median sternotomy.~   "
185661|NCT01134458|"~     The investigators propose an evaluation that will assess three important components of risk~     communication:~        1. provide patients with personalized risk communication using the risk calculator~          developed by FIMDM and health information taken from the Living with Coronary Artery~          Disease program~        2. provide personalized tailored patient feedback to help initiate and maintain specific~          cardiovascular CVD-related behaviors(e.g., medication adherence, exercise, diet, smoking~          cessation) to reduce their risks.~        3. evaluate how this feedback can be incorporated into clinical care by examining 3 month~          patient outcome and provider responses to the risk information.~   "
185662|NCT01134445|"~     The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the~     treatment of patients with hip joint disease requiring a total hip replacement. Patients who~     enter the study will be evaluated at regular intervals following hip surgery using patient,~     clinical and x-ray assessments.~   "
185663|NCT01134432|"~     The conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is~     high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will~     recur after end of treatment or during the gradual reduction in dose of the drug. As a~     result, many patients will finally be splenectomized or be treated with long-term~     glucocorticoids or other immunosuppressive drugs as azathioprine or cyclophosphamide. Recent~     studies have shown however, that some patients will respond to treatment with the chimeric~     anti-CD 20 antibody Rituximab and is some cases, the response is permanent. In most of the~     studies, Rituximab has been used in refractory disease or at least as second line treatment.~     In this study, patients with AIHA are randomized to receive either high-dose prednisolone~     with gradual reduction in dose over 2-3 months alone or in combination with Rituximab 375~     mg/m2 once a week for 4 weeks. The efficacy of Rituximab will be evaluated by a comparison of~     the patients in the two treatment arms. The primary treatment goal is a reduction in the~     number of patients who obtain long-term complete or partial remission. The secondary~     treatment goal is a reduction in patients who will be splenectomised or receive other~     immunosuppressive drugs. Finally a comparison of side effects of the treatments will take~     place.~   "
185664|NCT01134419|"~     The investigators propose to test the hypothesis that implementation of a comprehensive~     handoff program (CHP) - i.e., implementation of a computerized handoff tool along with~     teamwork training for pediatric residents on inpatient units at Children's Hospital Boston -~     will lead to reductions in resident miscommunications / medical errors and improvements in~     workflow and experience on the wards.~   "
185665|NCT01134406|"~     The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy~     (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of~     the knee, in patients who have failed to respond adequately to conservative non-pharmacologic~     therapy and simple analgesics.~   "
185666|NCT01134393|"~     The general aim of this trial to determine the efficacy as measured by the percentage of~     patients reaching blood pressure goal at the end of the treatment period at 12 weeks.~     In-clinic blood pressures, home blood pressures and safety will be carefully monitored.~   "
185667|NCT01134380|"~     The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to~     thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to~     an adjusted thienopyridine treatment on STEMI patients treated by primary PCI within the 24~     hours following the first chest pain.~   "
185668|NCT01134367|"~     The purpose of this study is to examine patient's perspective of symptom control and impact~     of gastroesophageal reflux disease (GERD) on daily life.~   "
185669|NCT01134354|"~     Design:~      Prediction trial, up to 10 sites in Asia and Europe~      Goal:~      To better understand the success or failure after orthopedic trauma surgery by developing~     a model that can be applied clinically as a user-friendly baseline questionnaire - capable~     of predicting success or failure based on a patient's pre-surgical expectations of their~     final outcome and to validate a novel outcomes measure (TOM).~      Primary aim:~      To assess the psychometric properties of predictive validity, internal consistency and~     reproducibility of the trauma expectation factor (TEF) in the Eurasian population.~      Secondary aim:~      To assess the psychometric properties of criterion validity, internal~     consistency,reproducibility, and sensitivity to change of the TOM in the Eurasian population.~      Key questions related to patient and surgeon expectations:~        -  How different, or similar, are patient and surgeon expectations?~        -  Do expectations change over time?~        -  Do patient expectations predict outcomes in validated measures use today?~   "
185670|NCT01134341|"~     This study is designed to determine the recommended dose, safety, pharmacokinetics, and early~     efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or~     refractory CTCL.~   "
185671|NCT01134328|"~     The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its~     components in the prevention of the signs and symptoms of allergic conjunctivitis in~     Enviro-CAC™ Model.~   "
185672|NCT01134315|"~     The objective of this study was to observe the safety of paricalcitol utilization in~     pediatric participants (ages 0 to 16 years old) being treated for secondary~     hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up~     to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in~     blood).~   "
185673|NCT01134302|"~     The purpose of this trial is to determine, at 3 years of life, how the neurologic and~     functional outcomes in infants with single ventricles are different when comparing children~     treated with the Hybrid strategy to the Norwood strategy.~   "
185674|NCT01134289|"~     This study aims to compare the alternative current and the direct current signal changes of~     photoplethysmography between both feet during one side lumbar sympathetic block.~      The hypothesis is that signal changes occur earlier than other indices to decide whether it~     is successful following lumbar sympathetic block on only one-side.~   "
185675|NCT01134276|"~     Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage~     (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage~     (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase~     difficulties in determining a proper resection margin. The purpose of this study is to~     compare the clinicopathological outcomes according to the methods of preoperative biliary~     drainage in periampullary cancers causing obstructive jaundice, and to find out a proper~     biliary drainage method.~   "
185676|NCT01134263|"~     The purpose of this study is to demonstrate that different CYD Dengue vaccine lots~     manufactured using the same method and in the same location but at different times produce an~     equivalent immunological response.~      Primary Objective~        -  To demonstrate that three different Phase III lots of CYD Dengue vaccine induce an~          equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against~          the four parental serotypes.~      Secondary Objectives:~        -  To demonstrate that data from one Phase II lot and pooled data from Phase III lots of~          CYD Dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs~          against the four parental serotypes.~        -  To describe the safety (in terms of solicited injection site and systemic reactions and~          unsolicited adverse events) of the CYD Dengue vaccine in all subjects after each dose.~   "
185743|NCT01133392|"~     This study will compare how the body treats 2 different forms of insulin lispro and how they~     affect blood sugar levels.~   "
185677|NCT01134250|"~     This Phase Ib/II study is an open label, multicenter study.~      The study is divided in two parts:~      Phase I: an open-label, dose escalation study of F16IL2 in combination with paclitaxel for~     patients with solid tumours, bladder cancer, breast cancer, metastatic melanoma,~     mesothelioma, NSCLC, prostate cancer and sarcoma amenable to taxane therapy.~      Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in~     combination with paclitaxel, equivalent to stage 1 of the Simon two-stage phase II design,~     for patients with metastatic melanoma, breast cancer and NSCLC amenable to taxane therapy.~   "
185678|NCT01134237|"~     Intrapleural thrombolytic treatment with urokinase for retained hemothorax is effective and~     safe. However, previous study was limited in prospective observation study without control~     group.~   "
185679|NCT01134224|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the blood~     glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects~     with type 2 diabetes.~   "
185680|NCT01134211|"~     The primary objective of this trial is to evaluate the subjective performance of two~     different daily disposable contact lenses in a population of daily disposable lens wearers.~   "
185681|NCT01134198|"~     This research will evaluate the impact of blocking central and peripheral glucocorticoid~     receptors on stress sensitivity and the risk of relapse to cocaine use in treatment-seeking~     cocaine-dependent individuals. Mifepristone (RU-486) will be the glucocorticoid antagonist~     used.~   "
185682|NCT01134185|"~     This is a single centre, open-label phase I trial to investigate the effects of moderate to~     severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy~     volunteers. Furthermore the short-term safety and tolerability of a single dose of~     prucalopride will be assessed.~   "
185683|NCT01134172|"~     The purpose of this study is to learn more about how being treated for breast cancer affects~     patients' employment, financial situation, and quality of life on a short-term basis and on a~     longterm basis. Most studies of employment after breast cancer have focused on Caucasian~     women.This study will evaluate the impact of breast cancer on the lives of women from~     different ethnic groups.~   "
185684|NCT01134159|"~     Multicenter, retrospective registry to collect 9-12 month follow-up data to evaluate major~     adverse cardiac events in patients whom have undergone percutaneous coronary intervention and~     received either Taxus Liberte or Xience V.~   "
185685|NCT01134146|"~     The goal of this clinical research study is to find the highest tolerable dose of radiation~     that can be given to directly to the pleura (the outer lining of the lungs) using intensity~     modulated radiation therapy (IMRT) in patients with MM who have had a pleurectomy.~   "
185686|NCT01134133|"~     Hospital inpatients who have gurgling sounds heard during speech or breathing have been~     observed to have a higher risk of hospital acquired pneumonia. Patients who gurgle and who~     consent to participation will be randomized to receive routine clinical management or~     management to include measures employed to reduce risks of aspiration, namely, 1. head of bed~     up (30 degrees or higher), 2. swallowing evaluation by speech therapist (and feeding~     predicated on formal evaluation), 3. prompting managing physicians to reduce sedating~     medications to minimal effective dose.~   "
185687|NCT01134120|"~     The purpose of this study is to find out the safe dose range of the study drug in patients~     with myeloproliferative disorders.~   "
185688|NCT01134107|"~     Patients will continue to use their current insulin pump for this study. Patients will~     receive insulin lispro and insulin aspart during this study. One medication will be taken for~     12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor~     will know which medication is being taken at any time. The order in which the two medications~     are taken will be determined by chance.~   "
185689|NCT01134094|"~     This study will determine whether operative management confers improved short and long−term~     outcomes for patients with isolated AO type 44−B1 distal fibula fractures when compared with~     non−operative management.~   "
185690|NCT01134081|"~     The purpose of this observational research study is to understand more about wound healing of~     gum tissue. This study was the biomarker study of a small cohort of study participants~     derived from NCT01547962 (completed). Two surgical sites of each patient were randomly~     selected to receive CelTx™ as a donor material in one site and conventional autograft using~     keratinized tissue from the palate as the donor material at the contralateral (opposite side)~     site. Fluids collected from between a tooth and the gum and directly from wounds contain~     proteins that occur in different levels as the wound healing process proceeds. In this~     research study wound fluid will be collected from the donor palate site (roof of your mouth)~     and the treated sites on your gum before and after placement of CelTx and conventional~     treatment (tissue from the roof of your mouth) to measure which proteins and how much of each~     are present during the first 4 weeks of wound healing.~   "
185691|NCT01134068|"~     Suspected pulmonary embolism (PE) is a frequent clinical problem and remains a diagnostic~     challenge. The diagnostic approach of PE relies on sequential diagnostic tests, such as~     plasma D-dimer measurement, multi-slice computed tomography (MSCT) and pulmonary angiography.~     In addition, the diagnostic workup is usually stratified according to the clinical~     probability of pulmonary embolism. Clinical probability has a fair predictive accuracy either~     evaluated implicitly or by clinical prediction rules1 and is useful for identifying patients~     with a low prevalence of pulmonary embolism who can be usually fully investigated by non~     invasive tests.The D-dimer test has been extensively evaluated in the exclusion of pulmonary~     embolism, particularly in outpatients. ELISA D-dimer and second-generation latex~     agglutination (immuno-turbidimetric tests) have a remarkably high sensitivity and have been~     proved safe first-line tests in association with clinical probability to rule out pulmonary~     embolism in outcome studies. The clinical usefulness of D-dimer is defined by the proportion~     of patients in whom pulmonary embolism may be ruled out by a normal result and it is~     determined by the specificity. However, ELISA and second-generation latex agglutination~     (immuno-turbidimetric tests) tests have a quite limited overall specificity of around 35% to~     40%. Therefore, many investigators tried to increase the D-dimer thresholds in particular in~     elderly patients to increase the rate of patients in whom the diagnosis could be excluded by~     this easy and inexpensive test. Several studies have shown that D-dimer levels increase with~     age and which turns in a decreased specificity of the D-dimer test at the usual threshold in~     the elderly, and thus to a less useful test to exclude PE in older patients. Indeed, ELISA~     D-dimer is able to rule out PE in 60% of patients aged less than 40 years, but in only 5% of~     patients above the age of 80.8 In this study, raising the cut-off value to various points~     between 600 ng/ml and 1000 ng/ml increased specificity, but this came at the cost of safety~     with more false negative test results. In this analysis, however, no stratification was made~     for clinical probability and the sample was small.~      Recently, the investigators retrospectively assessed the value of a progressive cut-off~     adjusted to age in a wide sample of 1712 patients. This new cut-off was defined for D-Dimer~     test positivity in each patient by multiplying patient's age by 10. All patients with a~     D-Dimer level below 500mg/ml, and all patients above 50 years whose D-Dimer levels were~     inferior to their age multiplied by 10 were considered as having a negative D-Dimer test. The~     exact derivation and validation of this new D-dimer cut-off is described hereafter. Using~     the conventional cutoff, the VIDAS® D-Dimer test was negative (below 500 mg/ml) in 512/1712~     patients (29.9%) and none had PE during initial workup or the three-month follow-up period.~      Using the cutoff adjusted to age (cutoff for D-Dimer test positivity equals age multiplied by~     ten, in mg/ml), the figure was as follows. D-Dimer levels were below the adjusted cutoff in~     615/1712 patients (35.9%, number needed to test 2.8). This represented a statistically~     significant 20.1% increase in the number of patients in whom the D-Dimer test was considered~     as negative, p=0.0002. Of these 615 patients, 5 had PE during initial workup (0.8%, 95~     percent confidence interval 0.4 to 1.9%).~      These data suggest that adopting this progressive cut-off in patients above 50 years, could~     increase of about 20% the number of patients in whom PE could be excluded without further~     testing, with an acceptable safety profile as the three-month thromboembolic rate remained~     very low.~      Therefore, the investigators plan a prospective outcome study in which this progressive or~     new cut-off (age X 10 ng/ml) in patients above 50 years will be used. In this multicentre~     study, clinical probability will be assessed by the simplified revised Geneva revised score~     (Table 1) and an ELISA D-dimer test will be performed [Vidas D-Dimer Exclusion® test~     (Biomérieux, Marcy l'Etoile, Paris, France)]. Patients with a non high clinical probability~     with the simplified revised Geneva score and a normal new D-dimer cut-off with the Vidas~     D-dimer Exclusion®, (Biomerieux, Marcy l'Etoile, France) will be considered as not having PE,~     and will be followed for three-months to assess possible VTE recurrences. The main outcome~     will be the rate of thromboembolic events during a formal 3-month follow-up in patients not~     anticoagulated on the basis of this strategy. Patients with positive D-dimers will be~     investigated with MSCT as currently admitted.~   "
185692|NCT01134055|"~     The purpose of this study is to determine the safety and efficacy of different dosage~     regimens of pazopanib eye drops for the treatment of neovascular age-related macular~     degeneration.~   "
185693|NCT01134042|"~     The purpose of the study is to compare the efficacy and safety of fluticasone~     furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with~     fluticasone furoate inhalation powder administered alone once daily each evening in~     adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over~     a 24-week period.~   "
185694|NCT01134029|"~     The researchers propose a randomized controlled trial to evaluate how well an intervention,~     Planned Care for Obesity & Risk Reduction (Planned CORR), supports primary care treatment of~     obesity in adults with at least one cardiovascular risk factor (CVRF).~   "
185695|NCT01134016|"~     A phase I study to determine the maximum tolerable dose (MTD) and to evaluate~     pharmacokinetic, safety/tolerability and efficacy profiles of antroquinonol (Hocena®) in~     non-small cell lung cancer (NSCLC) subjects refractory to conventional treatment modalities~   "
185696|NCT01134003|"~     retrospective and prospective data collection for a database. Patients will have had or are~     going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System~   "
185697|NCT01133990|"~     The purpose of the Phase Ib portion is to find out the highest dose of study drug that can~     safely be given when tested in a small group of subjects.~      The purpose of the Phase II portion is to find out how safe the study drug is when taken at~     the highest dose in a larger group of subjects.~   "
185700|NCT01133951|"~     Gastric cancer is the fourth most common type of cancer and the second leading cause of~     cancer-related death in the world. In China, more than 390,000 new patients are diagnosed~     with gastric cancer and more than 300,000 patients are killed by the terrible disease~     annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is~     highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection~     appears to reduce the risk of gastric cancer. However, several recent controlled~     interventional trials by H. pylori eradication to prevent gastric cancer have yielded~     disappointing results. The exact effect of H.pylori eradication on prevention of gastric~     cancer is unclear up to now. To clarify this problem, the investigators conducted a~     prospective, randomized, double-blind, placebo-controlled, population-based study to~     determine whether H pylori eradication would reduce the incidence of gastric cancer in a~     high-risk population in China.~   "
185701|NCT01133938|"~     Several risk factors for the development of osteonecrosis of the femoral head following~     treatment of developmental dislocated hip have been reported. The need for further research~     with a large-enough sample size including statistical adjustment of confounders was demanded.~     The purpose of the present study was to find reliable predictors of osteonecrosis in patients~     managed for developmental dislocation of the hip and to evaluate if delayed treatment~     increased the risk of residual acetabular dysplasia requiring secondary surgeries.~   "
185702|NCT01133925|"~     Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the~     use of overlapping drug-eluting stents. Whether the substantial impairment of arterial~     healing observed at sites of overlap in preclinical pathologic studies persists in patients~     undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels~     requiring stents in overlap are prospectively assigned to receive multiple zotarolimus~     eluting stents (Resolute Sprint). The completeness of stent struts coverage and/or late~     malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up.Data will~     be compared to the historical arm of ODESSA trial (patients treated with multiple~     sirolimus-,paclitaxel polymer-or zotarolimus eluting stents).~   "
185703|NCT01133912|"~     Primary objectives :~      1. To evaluate the recommended dose of the combination of paclitaxel, gemcitabine, and~     lapatinib (Tykerb®) (PGT) as preoperative chemotherapy in patients with HER2 positive~     operable breast cancer~      Secondary objectives :~        1. To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of PGT~        2. To determine the safety profile~        3. To assess pCR in primary tumor and axillary LN~        4. To evaluate clinical response rate, disease free survival (DFS), and overall survival~          (OS)~        5. To assess breast conserving rate after preoperative PGT~   "
185704|NCT01133899|"~     Glycocyamine (guanidinoacetic acid - GAA) is the biochemical precursor of creatine, which is~     phosphorylated and plays an important role as a high-energy carrier in the muscle. Since GAA~     can be administered in liquid solutions, such as sports drinks, it could be hypothesised that~     GAA could easily enhance creatine biosynthesis with clear physiological effects yet to be~     determined. No single study has examined the influence of GAA on health, human performance or~     body composition indicators in healthy human subjects. Moreover, the most effective dose of~     GAA is yet to be find. Finally, the adverse effects of GAA supplementation in humans are not~     determined. The main aims of the present study will be to identify if the 6-weeks of GAA~     supplementation improves human performance and body composition, to determine most effective~     dose regimens of GAA, and to analyze adverse effects of GAA supplementation. Forty eight~     healthy, trained (> 2 yr training experience) male and female subjects (aged 20 to 25 years)~     will give their informed consent and volunteer to participate in the study, which will obtain~     the approval of the University's Ethical Advisory Commission. The subjects will be allocated~     to four randomly assigned trials: ingesting GAA (1.2, 2.4, 4.8 g of GAA in a single dose) or~     placebo (PLA) for 6 weeks in a double-blind design. All testing including blood and urine~     samples, body composition and muscle strength and exercise performance (both aerobic and~     anaerobic) will be conducted at presupplementation (baseline), at 1 week, at 2 weeks, at 4~     weeks, at 6 weeks of supplementation and at 8 and 10 weeks (2 and 4 weeks after the end of~     supplementation) to analyze wash-out period. According to previous investigations, the~     investigators expect that ingestion of GAA will significantly increase both serum creatine~     and total homocystein. The investigators expect that ingestion of GAA will significantly~     improve muscle strength parameters and exercise performance results as compared to placebo in~     long term. The investigators also expect to find prevalence of side-effects (i.e.~     gastrointestinal distress, retention of fluid).~   "
185705|NCT01133886|"~     The purpose of this study is to assess the response rate at 6 months in Myelodysplastic~     Syndrome (MDS) patients, Chronic Myelomonocytic Leukaemia (CMML-2) patients, and Acute~     Myeloid Leukaemia (AML) patients with up to 30% bone marrow blasts, treated with low-dose~     decitabine who have previously failed therapy with 5-azacitidine.~   "
185706|NCT01133873|"~     The purpose of this study is to determine the daily maximum tolerated dose of propoxyphene~     napsylate in healthy subjects.~   "
185707|NCT01133860|"~     The term MYH9-related disease (MYH9RD) includes four genetic disorders: May-Hegglin anomaly,~     Sebastian syndrome, Fechtner syndrome, and Epstein syndrome. All these disorders derive from~     mutation of a unique gene, named MYH9, and they have been recognized as different clinical~     presentations of a single illness that was named MYH9RD. All patients affected by MYH9RD~     present since birth with thrombocytopenia, which can result in a variable degree of bleeding~     diathesis; some of them subsequently develop additional clinical manifestations, such as~     renal damage, sensorineural hearing loss, and/or presenile cataracts. Eltrombopag is an oral~     thrombopoietin receptor agonist that stimulates proliferation and differentiation of~     megakaryocytes, the bone marrow cells that produce blood platelets. This drug is effective in~     increasing platelet count in healthy volunteers, as well as in patients affected by some~     acquired thrombocytopenias, such as idiopathic thrombocytopenic purpura and HCV related~     thrombocytopenia. The purpose of this study is to determine if eltrombopag, administered~     orally at the dose of 50 or 75 mg/daily for up to 6 weeks, is effective in increasing~     platelet count of patients affected by MYH9RD. Further aims of this study are to test if~     eltrombopag is effective in reducing bleeding tendency of MYH9RD patients; to evaluate safety~     and tolerability of eltrombopag in patients with MYH9RD; to evaluate in vitro function of~     platelets produced during therapy in patients responding to this drug.~   "
185708|NCT01133847|"~     The objective of this randomized clinical trial is to address unanswered questions about the~     relative effectiveness of treatments for children with both Attention Deficit Hyperactivity~     Disorder (ADHD) and significant reading difficulties (RD). The study evaluates attentional~     and word reading outcomes for students with both conditions when provided with either (a)~     ADHD treatment alone, (b) RD treatment alone, or (c) the combination of ADHD and RD~     treatment.~   "
185757|NCT01133210|"~     The purpose of this study is to determine the effect of maraviroc therapy in obese insulin~     resistant subjects on:~        1. Plasma triglyceride concentration~        2. Plasma HDL-cholesterol and LDL-cholesterol concentrations~        3. Plasma markers of cardiometabolic risk and inflammation~   "
185709|NCT01133834|"~     Objectives:~      Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to~     irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During~     meningococcal sepsis and meningitis, a myriad of cells release cytokines within the~     intravascular environment and subarachnoid space. Cytokines are key molecular messengers that~     play key roles in orchestrating and mediating the metabolic, endocrine and coagulation~     responses to meningococcal infection. The aim of the present study is to determine the~     profile of different cytokines in serum and cerebrospinal fluid during MD, as well as relate~     the level of these cytokines to severity of MD.~      Design:~      Prospective, nonrandomized study.~      Setting:~      Tertiary referral intensive care unit.~      Patients:~      Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and~     cerebrospinal fluid will sample from children and adults with MD.~   "
185710|NCT01133821|"~     This proposed study is designed to compare the efficacy of interpersonal and social rhythm~     therapy (IPSRT) alone to IPSRT plus medication as an acute treatment for bipolar II~     depression. The investigators propose to conduct a randomized, controlled, trial comparing~     the effects of IPSRT plus pill placebo to IPSRT plus quetiapine on depressive symptoms in~     individuals suffering from Bipolar II depression. The investigators will also examine the~     impact of treatment on psychosocial function.~   "
185711|NCT01133808|"~     The purpose of the investigators study is to compare the rates of childhood diarrhea at the~     community level before and after the rotavirus vaccination program in León, Nicaragua. From~     preliminary studies, the investigators anticipate about a 28% reduction in diarrhea following~     the vaccination program among children who received the vaccine, and a smaller reduction in~     diarrhea among children who did not receive the vaccine, due to the effects of herd~     immunity. In addition, the investigators will collect stool samples from children who~     develop diarrhea in order determine the etiology of childhood diarrhea in the post-rotavirus~     immunization era.~   "
185712|NCT01133795|"~     The objective of the study was evaluate the effect of administration of midodrine and albumin~     on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.~   "
185713|NCT01133782|"~     Viral respiratory infections are common worldwide. It has been suggested that nucleic acid~     amplification tests, enabling a rapid etiologic diagnosis, may be useful in reducing~     antibiotic prescriptions rates. The objective of this study was to evaluate if access to a~     multiplex real-time PCR method would have an impact on antibiotic prescriptions for acute~     respiratory tract infections (ARTIs), in primary care. Adult patients with respiratory tract~     infections will be prospectively included. Nasopharyngeal and throat swabs will be analyzed~     with a multiplex real-time PCR method, targeting 13 viruses and two bacteria. Samples will be~     collected during the winter season (October-April). Patients will be open-label randomised to~     receive a rapid result (the following day) or a delayed result (after 10+/-2 days). The~     investigators are planning to include approximately 400 patients. Prescription of antibiotics~     will be measured at initial visit as well as at a follow-up visit 10+/-2 days later. Primary~     endpoint is antibiotic prescription in the acute phase (initial visit) and secondary endpoint~     antibiotic treatment (ongoing or initiated) at follow-up visit. The hypohesis is that access~     to a method with the ability of providing a rapid etiologic diagnosis of respiratory~     infections will affect the use of antibiotics in outpatient care of adult patients with ARTI.~   "
185714|NCT01133769|"~     About 90% of chest injuries in America are due to blunt forces, mostly as a result of motor~     vehicle collisions and falls. Severity varies from minor bruising to severe chest injuries.~     For several years, clavicle (collarbone) fractures have been treated without surgery~     (non-operatively), even when the fracture is out of place (displaced). Over the last few~     years, however, treatment has changed more towards surgical fixation (operative), because of~     the sometimes difficult healing in clavicle fractures that are displaced. Several research~     studies have shown that cases in which the clavicle fracture never heals completely~     (non-union) are more frequent after nonoperative treatment, compared to operative fixation.~     In those cases, surgery is still required, only later (secondary surgery). Further, clavicle~     malunion, in which the fracture heals but is still out of place) has been shown to be high~     after nonoperative treatment. Recent published research studies have shown better function,~     higher patient satisfaction, earlier return to activity (use of the arm) and decreased~     nonunion and malunion following surgery, also called open reduction/internal fixation.~     Despite recent published research, there is still a lack of agreement on when surgical~     fixation should be performed for clavicle fractures.~      Patients with chest injuries often have clavicle fractures. Chest injuries can restrict~     patients' ability to breathe, cough, stand, walk and leave the hospital. Although it is~     unusual that chest injuries can be improved with surgery, patients with clavicle fractures~     and chest injuries might recover faster if the clavicle fractures were repaired.~      Patients are being asked to take part in the study they have sustained a clavicle fracture~     associated with a chest injury with or without any other injury to the abdomen, or arms or~     legs. The aim of this study is to determine the difference in the hospital length of stay,~     intensive care unit length of stay, respiratory rehabilitation (recovery of good respiratory~     function), functional outcome, ability to become mobile again, complications and risk of~     dying in trauma patients with chest injury and clavicle fracture treated operatively versus~     non-operatively.~   "
185715|NCT01133756|"~     The purpose of this study was to determine the maximum tolerated dose (MTD)/recommended Phase~     II dose of lenvatinib administered in combination with carboplatin and gemcitabine (Phase IB)~     and to evaluate the safety and tolerability of E7080 administered in combination with~     carboplatin and gemcitabine compared to carboplatin and gemcitabine alone (Phase II) in~     participants with platinum-sensitive recurrent ovarian cancer.~   "
185716|NCT01133743|"~     This is a phase II, non-randomized, single institution study in symptomatic, previously~     untreated CLL patients. All patients will receive the study drug, lenalidomide, given PO~     daily continuously on a 28 day cycle at the starting dose level of either 2.5 mgs or 5 mgs~     with dose escalations to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily~     will be administered on days 1-7, 14 and 21 of each cycle. Patients will be treated with~     lenalidomide and dexamethasone to 2 cycles past CR or to a maximum of 18 cycles, each cycle~     of 28 days duration. Primary endpoint is response.~   "
185717|NCT01133730|"~     Hand or wrist surgery often requires the use of bony material in order to accomplish any~     associated reconstructive aspects required for the surgery. The iliac crest is often used as~     the source of bone for such surgery and harvesting from this site is performed simultaneously~     with the hand/wrist surgery. In terms of anesthesia, patients typically receive a~     supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the~     bone graft, though spinal block may also be performed. This study will look at the use of a~     transversalis fascia plane (TFP) nerve block (ie, to numb the nerves going to the iliac~     crest) in combination with a general anesthetic to see if post-operative pain and opioid~     consumption is reduced using the TFP block.~   "
185758|NCT01133197|"~     This study is designed to define the impact of thumb arthritis on patient's general health.~     As a secondary objective, data will be analyzed to determine the effects of medical and~     musculoskeletal comorbidities on the rating of upper extremity function by the patient.~   "
185718|NCT01133717|"~     Obstructive sleep apnea (OSA) is a prevalent sleep breathing disorder in the general~     population in which recurrent collapse of the upper airway occurs during sleep. OSA is more~     prevalent in subjects with stroke and is associated with a 3 fold increased risk of stroke.~     This makes it a serious public health problem. Approximately 50% of subjects with OSA are~     asymptomatic and are often only detected following investigation for the cause of heart~     disease or a stroke. In subjects who are treated for OSA many are intolerant or poorly~     compliant with treatment. Therefore, the identification of those subjects with OSA most at~     risk of adverse consequences such as stroke is important, so that treatment compliance can be~     improved.~      Therfore, the investigators want to determine if compared to subjects without OSA, subjects~     with OSA have evidence of increased stroke risk by assessment of changes in cerebral blood~     flow (cerebrovascular reactivity) as measured on Doppler ultrasound of the middle cerebral~     artery (TCD) and blood oxygen level-dependent magnetic resonance imaging of patterns of~     cerebral blood flow (BOLD MRI) to two stimuli. These stimuli include increased carbon dioxide~     concentrations (causes increased cerebral blood flow) and reduced oxygen concentrations~     (causing decreased cerebral blood flow). In order to deliver these stimuli the investigators~     will use a special machine (RespiractTM) which allows for the precise control of carbon~     dioxide and oxygen concentrations in the lungs and blood. The precise control of carbon~     dioxide and oxygen in conjunction with BOLD MRI has enabled the production of detailed maps~     of the brain that identify areas of healthy and abnormal blood supply.~   "
185719|NCT01133704|"~     This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous~     antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic,~     hormone-refractory prostate cancer.~   "
185720|NCT01133691|"~     -  Background: Fasting is mandatory for safety of anesthesia in elective surgery and~          imaging but gives rise to discomfort, hunger and thirst especially in children.~          Internationally accepted fasting times are often prolonged because of organisational~          delay in operating theatre.~        -  Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time~          without enlarging the residual gastric contents compared to overnight fast. There is no~          difference between residual gastric contents after 4 hours of fasting after a light meal~          compare to 6 hours in healthy children.~        -  Examination of gastric volume using magnetic resonance imaging after overnight fasting~          and subsequent scans after either clear fluid intake or intake of a standard breakfast~          are performed in children aged 6 - 12 years. Time course after fluid intake is followed~          with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting~          time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours~          after the meal. Volume of gastric contents will be compared with a standardized~          ultrasonographic view of the stomach.~   "
185721|NCT01133678|"~     Primary~      Compare response rates to induction chemotherapy consisting of cisplatin/paclitaxel/cetuximab~     +/- everolimus.~      Secondary~      Determine the maximum administered dose (MAD), maximum tolerated dose (MTD), dose limiting~     toxicity (DLT), and safety of everolimus with cisplatin/paclitaxel/cetuximab induction~     chemotherapy.~   "
185722|NCT01133665|"~     The purpose of this study is to study specific FcRIIIa polymorphisms and their correlation~     with clinical outcome in subjects treated with cetuximab and lenalidomide.~   "
185723|NCT01133652|"~     Children fear having an intravenous (IV) needle placed because of the pain that they will~     experience. The more needle punctures that a child has to endure before the IV is~     successfully placed, the greater the pain experienced and anxiety suffered. In addition,~     false starts increase the demands on medical staff and can increase the length of the~     emergency department stay. Often, veins are difficult to see or feel, particularly in an~     unwell, dehydrated child or in young infants who have more fat below the skin surface. Also,~     the venous pattern below the skin surface naturally varies from person to person and~     therefore success in placing IVs leaves room for improvement. Technology may be able to play~     an important role is improving the rates of success. The investigators wish to investigate~     whether the use of either an Ultrasound machine or a VeinViewer machine can improve the rate~     of success of the initial attempt (skin puncture) at peripheral IV placement in comparison to~     the current standard approach.~   "
185724|NCT01133639|"~     This will be a randomized double-blind placebo-controlled clinical trial that will accept all~     eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be~     randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg~     orally every 8 hours for five days) plus standard of care or placebo plus standard of care.~     The purpose of this study is to evaluate the effects of ketorolac plus standard of care on~     post-operative pain control and radiographic osseous healing. Patients will be assessed for~     pain via a validated pain questionnaire and for delayed unions via a radiographic scoring~     system shown to have both high inter- and intra-observer reliability by a blinded board~     certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated~     including adverse events and time to regular shoe gear and activities.~   "
185725|NCT01133626|"~     The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis~     function.~   "
185726|NCT01133613|"~     The objective of the study is to determine the safety and tolerability of two different~     formulations of BMP-7 for the treatment of osteoarthritis of the knee.~   "
185727|NCT01133600|"~     The purpose of the study is to evaluate the overall burden to the participant (economic,~     quality of life, patients satisfaction and freedom from side effects) when treating Gram~     positive infections of the foot in diabetic adults with daptomycin versus vancomycin.~   "
185744|NCT01133379|"~     This study is for people with sensitive teeth and involves going to the dentist for 6 visits~     over 8 weeks. During the first 2 weeks, everyone will just brush their teeth two times a day~     with the fluoride toothpaste provided.~      Then you will be assigned to a mouthwash group if you qualify to continue in the study. Two~     groups will get mouthwash with a certain amount of an experimental ingredient and one group~     will get a mouthwash with no experimental ingredients. You will have an equal chance of being~     assigned to any one of the three groups.~      For the next 6 weeks, you will rinse with your assigned mouthwash after brushing. A dentist~     will look at your mouth, teeth, tongue and gums and check for sensitive teeth. The~     investigators will see if the mouthwash helps to reduce tooth sensitivity during the study.~   "
185728|NCT01133587|"~     To meet the requirement for increased patient involvement, several Community Mental Health~     Centres (CMHC) have initiated a service called patient-guided admissions. The investigators~     will compare a group with patient guided admission/self-referral to inpatient beds with a~     group having treatment as usual.~      It is expected that patients in the intervention group will experience more increased feeling~     of coping (patient activation) after 4 months and 12 months as a result of participating in~     patient-guided admissions than patients getting treatment as usual. In addition the total~     number of inpatient days either in the CMHC, psychiatric hospital or community rehabilitation~     centre is expected to be clearly lower in the intervention group than in the~     'treatment-as-usual' group during one year after intake. Also the number of involuntary~     admissions either as inpatient or outpatient will be significant lower in the intervention~     group than the 'treatment-as-usual' group.The number of admissions in CMHC and psychiatric~     hospital, as well as the number of outpatient consultations in primary care, CMHC and~     psychiatric hospitals, will be lower in the intervention group than in the~     'treatment-as-usual' group. Patients in the intervention group will experience improved~     mental health, increased feeling of coping (patient activation) and increased experience of~     recovery after 4 months and 12 months as a result of participating in patient-guided~     admissions.~   "
185729|NCT01133574|"~     This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance~     imaging (Part B)~   "
185730|NCT01133561|"~     The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in~     terms of improvement of both skin and systemic manifestations of psoriasis.~      The investigators assume that pioglitazone (one of thiazolidinediones readily available in~     Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in~     addition to improving the insulin resistance in peripheral tissues observed in many psoriatic~     patients and causing metabolic syndrome. This will allow to give a safer therapy than the~     available ones for psoriasis and to treat the patient in a more global perspective.~   "
185731|NCT01133548|"~     To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption~     in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper~     arms/shoulders using an application site rotation or a combination of application sites.~   "
185732|NCT01133535|"~     The purpose of this study is to collect standardized data on the diagnosis and management of~     idiopathic (unknown cause) recurrent acute pancreatitis. The intent is to collect data for at~     least five years to obtain information regarding long-term outcomes and obtain comparative~     effectiveness data.~   "
185733|NCT01133522|"~     The purpose of the study is to evaluate the safety and tolerability of multiple doses of~     evolocumab when given as an add-on to stable statin therapy.~   "
185734|NCT01133509|"~     In this pilot study, we intend to demonstrate that a great portion of women at high risk~     (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV~     testing via ThinPrep®Pap testTM and surveillance. We intend to provide improved access to~     healthcare and monitoring through administration of vaccine to eligible patients and 1 year~     follow up for patients involved in this study.~      Females meeting inclusion/exclusion criteria participating in the study (n=100) that have not~     had a cytology test in 2 or more years will be offered the Thin Prep® cytology test. This~     study will allow surveillance of disease through cytology and HPV DNA testing via collection~     of data using Thin Prep® cytology with reflex HPV DNA testing according to established~     guidelines as described below.~      Provide improved access to healthcare and monitoring through administration of vaccine for~     eligible females as established by guidelines. Patients will receive first vaccine in the ED~     and will have arranged follow up for administration of the 2 month and 6 month series of the~     HPV vaccination. Through data collection, we intend to determine if there is a need for~     vaccination and determine if patients are likely to follow up..~   "
185735|NCT01133496|"~     The purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of~     Dr. Reddy's and Fosamax Tablets 70 mg of Merck & Co.~   "
185736|NCT01133483|"~     The purpose of this study is to~        1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine~          HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets.~        2. Monitor the adverse events and ensure the safety of subjects.~   "
185737|NCT01133470|"~     The purpose of this study is to~        1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine~          HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets.~        2. Monitor the adverse events and ensure the safety of subjects.~   "
185738|NCT01133457|"~     The objective of this study was to compare the single-dose relative bioavailability of Dr.~     Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®)~      1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.~   "
185739|NCT01133444|"~     The objective of this study was to compare the single-dose relative bioavailability of Dr.~     Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®)~      1 mg finasteride tablets under fasting conditions following administration of a 3 mg dose.~   "
185740|NCT01133431|"~     To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in~     healthy male subjects.~   "
185741|NCT01133418|"~     Currently, only two treatment modalities for pediatric attention deficit hyperactivity~     disorder (ADHD) are considered evidence-based: (1) pharmacological and (2) behavioral~     treatment. Recently, several studies have shown promising results suggesting efficacy for~     cognitive training interventions for children with ADHD. These interventions directly train~     cognitive function (i.e., attention, working memory) by having children practice cognitive~     skills using computerized tasks. In these studies, improvements related to the cognitive~     training intervention have been documented on neuropsychological tests, academic tasks, and~     parent ratings of children's ADHD behavior. Given the ubiquitous finding of increased~     reaction time (RT) variability among children with ADHD, the candidate worked with a group of~     developers to modify a cognitive training intervention to target RT variability. That is,~     train the children to be less variable in their responding. Initial clinical data from this~     intervention suggest that intervention exposure improves behavioral outcomes. However, an~     appropriate powered randomized clinical trial is necessary to experimentally demonstrate~     intervention efficacy.Sixty-four (64) children diagnosed with ADHD (either Predominantly~     Inattentive Type or Combined Type) will be randomly assigned to intervention or control~     conditions. Children in the intervention group will receive 8 weeks of the Computerized~     Progressive Attention Training (CPAT) intervention. Children in the control group will~     receive the CPAT intervention but there will be no progression in difficulty based on~     performance as in the intervention group. Children in both groups will be assessed~     pre-intervention and immediately after the 8-week training on neuropsychological, behavioral,~     and academic outcome measures. Hypothesis-driven data analyses will assess intervention~     efficacy.~      Hypothesis #1: Children in the experimental group exposed to the CPAT intervention will show~     greater improvement from pre- to post-intervention on neuropsychological tests compared to~     children in the control group.~      Hypothesis #2: Children in the experimental group exposed to the CPAT intervention will show~     greater improvement from pre- to post-intervention on parent and teacher behavioral ratings~     of ADHD behavior compared to children in the control group.~      Hypothesis #3: Children in the experimental group exposed to the CPAT intervention will show~     greater improvement from pre- to post-intervention on academic outcomes compared to children~     in the control group.~   "
185745|NCT01133366|"~     The purpose of this study is to assess how blood clotting and thinning time is effected when~     a single dose of warfarin is given alone and when a single dose of warfarin is given with~     mipomersen; to assess the blood levels of a single dose of warfarin, a single dose of~     mipomersen, and a single dose of warfarin when given with mipomersen; and to assess the~     safety of mipomersen when given with or without warfarin.~   "
185746|NCT01133353|"~     The purpose of this clinical trial is to study the therapeutic effect of tetrabenazine MR in~     children with Tourette's Syndrome, as measured by the improvement in total tic score of the~     Yale Global Tic Severity Scale (YGTSS).~   "
185747|NCT01133340|"~     This study is looking for a better way to define rectal tumors undergoing pre-operative~     radiation. MRI scanning generally results in more clear definition of the tumor that CT~     scanning. Insertion of radio opaque clips in the tumor site could also help to visualize the~     tumor better for radiotherapy treatment planning. The investigators believe both techniques~     would help the physician to define to cancer better than using CT scan alone. The~     investigators also will compare both techniques to define the better way to define the tumor.~   "
185748|NCT01133327|"~     The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used~     in conjunction with the FilterWire Embolic protection system for treatment of patients that~     suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.~   "
185749|NCT01133314|"~     The routine treatment of children with antimalarials will be monitored. Children with a~     positive malaria film and/or a positive rapid diagnostic test (RDT) will have a capillary~     blood sample taken to verify the diagnosis and to monitor the pattern of resistance.~   "
185750|NCT01133301|"~     Our study aims at contributing to a valid appraisal of the magnitude of naltrexone efficacy~     as an antidissociative agent by using a double-blind randomized controlled trial.~   "
185751|NCT01133288|"~     This study is to evaluate the safety of Yulex gloves when used by individuals who have~     documented allergy to natural rubber latex from Hevea brasiliensis. Yulex is a latex from a~     different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex~     and has not been allergenic in workers exposed to Yulex. The FDA has approved Yulex gloves~     for use in the general population and has recognized and labeled these gloves as Hevea~     Latex-free. The labeling still includes a precaution that Yulex gloves may pose a risk for~     development of allergy because Yulex does contain a small amount of Guayule protein. Yulex~     Corporation has proposed doing further studies to demonstrate safety and lack of~     allergenicity in a population that is prone to latex allergy. In the proposed pilot study,~     the investigators goal is to complete the protocol on 10 adults with spina bifida who are~     allergic to natural rubber latex who will wear Yulex gloves as part of their regular bladder~     and bowel care for approximately 30 minutes daily over a 3 month period. The investigators~     anticipate that the investigators will need to recruit and enroll up to 50 study participants~     to achieve a final sample of 10 adults with complete study data. Individuals with a history~     of anaphylaxis will be excluded from the study. The study participants will be tested for~     Yulex allergy by Glove Puncture Test as well as serology at the beginning and end of the~     study. The FDA Devices group has reviewed the study design and agreed that this is a suitable~     first pilot study.~   "
185752|NCT01133275|"~     The purpose of this research is to evaluate the use of lenalidomide and prednisone in people~     with Myelodysplastic Syndrome (MDS).~      Lenalidomide is a drug that alters the immune system and it may also interfere with the~     development of tiny blood vessels that help support tumor growth. Therefore, in theory, it~     may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food~     and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome~     (MDS) and in combination with dexamethasone for people with multiple myeloma (MM) who have~     received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being~     tested in a variety of cancer conditions. As it is being used in this study it is considered~     an investigational use. An investigational use is a use that is being tested and is not~     approved by the FDA.~      Prednisone is approved by the FDA to treat numerous conditions. In addition, prednisone is~     approved by the FDA to treat Low or Intermediate-1 IPSS Risk, non-del (5q) MDS.~      Study drug refers to the combination of lenalidomide and prednisone.~   "
185753|NCT01133262|"~     We have developed a prototype PET insert device that can be integrated into a clinical~     PET/computed tomography (CT) scanner to improve its image resolution to approximately 2.5 mm~     in all 3 dimensions within a reduced imaging field of view (FOV). This zoom-in imaging~     capability provides 6-fold improvement in volumetric image resolution over the current~     state-of-the-art clinical PET scanner, offering a tremendous opportunity for cancer imaging~     applications, in particular for those cases where a lymph node involvement will drastically~     alter the patient management plan. Accurate diagnosis and staging of head-and-neck cancer is~     known to be challenging because of the complex anatomy and large number of lymph nodes~     involved in this region. As a result, head and neck cancer imaging is an ideal candidate for~     evaluating the clinical usefulness of this novel imaging device.~   "
185754|NCT01133249|"~     Objective~      Describe the clinical and demographic characteristics of patients who undergo hip~     arthroplasty and document post operative outcomes.~      Examine the relationship between processes of care, hospital and surgeon associated outcomes~      Provide expanded data to characterize existing and evolving practice patterns, delivery of~     care, and resource utilization in the management of knee arthroplasty patients.~      Analyze and design ancillary studies to address unanswered questions.~      Disseminate findings through publication in peer-reviewed scientific journals.~   "
185755|NCT01133236|"~     The non-pharmacological measures that are widely practiced and recommended for HF patients,~     such as salt and water restriction, specially at moments of disease decompensation, still~     lack clearer evidence of their therapeutic effect.~   "
185756|NCT01133223|"~     Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be~     achieved with different strategies - varying from intravenous rtPA from mechanical~     thrombectomy. Recently, interventional approaches have been gaining attention and playing an~     increasing role in stroke care. However, no solid scientifical data is available to date. The~     investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can~     improve clinical outcomes in a specific stroke setting.~   "
185759|NCT01133184|"~     Impaired activity of Natural Killer (NK) cells has been proposed as a mechanism contributing~     to viral persistence in Hepatitis C Virus (HCV) infection. NK cells display anti-fibrotic~     activities by killing activated hepatic stellate cells (HSCs) that have lost the~     self-recognition marker; Major Histocompatibility (MHC) class I. Determining the~     down-expressed genes on NK cells necessary for their anti-fibrotic activity was never studied~     previously. This will allow us to study their role fully in phagocytosis process as well as~     their interaction of HSCs and therefore manipulating these genes using molecular techniques.~     Exploring the cellular functions of these genes will highlight their involvement in the~     progression of liver fibrosis and could be used as a therapeutic tool for preventing the~     disease.~   "
185760|NCT01133171|"~     Personalized risk communication methods have been used to educate patients that are at a high~     risk of developing cardiovascular disease. These methods include personalized counseling,~     printed brochures and individualized graphs describing the status of the risk factors. Very~     few studies have provided an interactive tool for patients to self-manage their risk factors~     and observe the changes in risk by making lifestyle changes and modifying other risk factors~     by seeking medical advice.~      This Rapid Response Project (RRP) builds upon these methods of communication by presenting~     the modifiable risk factors in the form of a personalized dashboard that highlights the~     contribution of these risk factors on the risk of developing a cardiovascular event. The~     modifiable risk factors that will be addressed in this study will include medical and~     lifestyle risk factors. The medical risk factors are hypertension, atrial fibrillation,~     diabetes mellitus and hyperlipidemia whereas the lifestyle risk factor is tobacco use.~      Our primary goal is to develop a prototype of the dashboard to educate patients and help them~     make informed decisions in modifying their risk factors to reduce the probability of a~     cardiovascular event or stroke. We will also evaluate the effectiveness of this tool by~     asking these patients to return after 6 months to determine if they have made any lifestyle~     changes or pursued medical intervention to reduce their cardiovascular risk. We will make~     qualitative observations on the knowledge retention of these patients while using the~     interactive dashboard.~   "
185761|NCT01133158|"~     Assess the combination of efficacy of the combination of rituximab, bendamustine,~     mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.~   "
185762|NCT01133145|"~     High energy trauma often results in severe soft tissue, bone and joint injury. Today, many~     methods and techniques exist to treat theses severely injured extremities. Surgical~     techniques include open reduction and internal fixation (ORIF), e.g. with screws and plates,~     soft tissue reconstruction by local or free flaps and joint reconstruction by arthroplasty,~     e.g. total knee arthroplasty. In few, very severe cases, those methods are not sufficient to~     restore function and amputation is the only option left.~      In 1908 the German surgeon Erich Lexer had the idea to transplant a joint. Due to the medical~     situation at his time the attempts failed.~      But the idea survived and was processed over the time. Transplant surgery and medicine~     developed, immunosuppressive drugs were established and animal models proved that bone and~     joint transplantation is technically feasible.~      In 1998 the first successful hand and in 2005 the first partial face transplantation was~     carried out. In 1996 we started our clinical femur and knee joint transplantation project.~   "
185763|NCT01133132|"~     This study will develop and test the benefits of a new ICCS (Interactive Cancer Communication~     System), a mobile Comprehensive Health Enhancement Support System (Survivorship CHESS) in~     colon cancer survivors. Survivorship CHESS will provide information, tools, and a support~     system based on our previous work with FRESH START and CHESS, two highly successful~     interventions that have promoted lifestyle change among cancer patients and survivors.~     Survivorship CHESS will be designed to help subjects develop 1) competence in information~     gathering, decision-making, and behaviors they are trying to change, 2) social support~     systems to help deal with the cancer experience, and 3) autonomy that comes with regaining a~     sense of control over their lives; this in turn, will help them adopt or maintain healthy~     lifestyle behaviors and improve their quality of life.~   "
185764|NCT01133119|"~     In the Cardiac Diagnostic and Interventional Unit (CDIU) at the Hospital for Sick Children~     (SickKids), minimally invasive procedures are performed to diagnose and treat a variety of~     congenital heart defects. Procedures are performed under general anesthetic and involve~     inserting a catheter through the skin and into the femoral vein or artery in the groin. In~     addition, the use of local anesthetic as a pain control regimen just prior to the removal of~     femoral artery or vein sheaths is used by some but not all cardiac interventionalists. Local~     anesthetic is infiltrated near the sheath insertion site, at the end of the procedure while~     the child is under general anesthetic, with the goal of decreasing pain at the insertion site~     and promoting comfort in the post-operative period. The use of local anesthetic depends on~     the choice of the individual practitioner and is not currently a routine practice for all~     patients.~      The investigators proposed research seeks to investigate whether the use of subcutaneous~     bupivacaine reduces pain levels in the post-operative period in children having cardiac~     catheterization procedures.~   "
185765|NCT01133106|"~     The overall goal of this study is to conduct a three-armed randomized controlled trial (RCT)~     in stroke survivors with depression to determine if a brief psychosocial-behavioral therapy~     intervention delivered in-person (arm A) or by telephone (arm B) is better than usual care~     (arm C), in terms of percent reduction in depressive symptoms and % of participants achieving~     remission of symptoms.~   "
185766|NCT01133093|"~     The purpose of this study is to assess the distribution, awareness and control of main~     cardiovascular risk factors in the Spanish population. The main study variables are:~        -  Lifestyles (tobacco, alcohol, nutrition, physical activity)~        -  Biological risk factors either well-established (blood lipids, glucose, insulin and~          blood pressure) or emergent (leptin, C-reactive protein and other markers of~          inflammation)~   "
185767|NCT01133080|"~     Double - Blind, Randomized, single centered study. The purpose of this study is to assess the~     feasibility of minocycline vs. placebo, added to atypical antipsychotic medications, for~     positive symptoms in adults suffering from schizophrenia.~   "
185768|NCT01133067|"~     Does the routine clinical practice of follow up after primary treatment in lung cancer~     patients has any utility.~   "
187700|NCT01107704|"~     The purpose of this study is to test the effectiveness of a multi-faceted communication~     intervention for family members of critically ill patients to reduce the family members'~     long-term symptoms of depression and anxiety.~   "
185769|NCT01133054|"~     The anomalous origin of right coronary artery (RCA) is a rare coronary anomaly. Recently, the~     detection of this anomaly has been more frequent as the use of cardiac multidetector computed~     tomography has become more popular. It can cause myocardial ischemia, syncope and sudden~     cardiac death. Surgical repair is generally recommended for symptomatic patients. However,~     there is controversy concerning the proper evaluation and treatment strategy for patients~     without documented myocardial ischemia.~      The stenotic lesion of anomalous origin of RCA will be assessed by fractional flow reserve~     (FFR).~   "
185770|NCT01133041|"~     Several novel imaging technologies are currently used for detection and differentiation of~     colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan~     (Pentax).~      Several previous studies have indicated that NBI without magnification can be useful for~     real-time differentiation of diminutive colonic neoplasias.~      To date, however, there are no studies comparing NBI with other imaging systems (FICE or~     i-Scan) for differentiation of diminutive colonic polyps.~      The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in~     real-time prediction of diminutive colonic polyps.~      In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will~     be observed with conventional colonoscopy, thereafter will be observed with new imaging~     systems.~      Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by~     reference to histological results obtained by endoscopic biopsy or polypectomy.~   "
185771|NCT01133028|"~     Children with Attention-Deficit/Hyperactivity Disorder (ADHD) comprise about 5-10% of the~     elementary school-age population. One place where children with ADHD have great difficulty is~     in being accepted by peers and in making friends. It has unfortunately been very difficult~     for the field to find good treatments for peer relationship problems for this population.~     Even when children with ADHD do improve their behavior, it is common that peers do not seem~     to like the child with ADHD any better. This may happen because children often have negative~     reputations with their classmates that are hard to change. That is, once a class of children~     get the impression that one child is disliked or the social outcast, even if that child's~     ADHD symptoms get better, the peer group may not notice any of these improvements. It is~     hypothesized that the elementary school teacher may be able to help peers notice positive~     behavior changes in children with ADHD when they do occur. This clinical trial will design~     and pilot-test an intervention that would train teachers in classroom practices to reduce the~     peer rejection of students with ADHD. The pilot test will be conducted in a summer program~     created to be similar to a regular school classroom in structure. If the treatment seems to~     succeed in the summer program, then it will be tried in regular classrooms in a future study.~   "
185772|NCT01133015|"~     This study will evaluate the relationship of Fractional Flow Reserve (FFR) and Minimal Lumen~     Area (MLA) by IntraVascular UltraSound (IVUS) by comparing the results of the both tests~     which is done as a part of the cardiac catheterization.~   "
185773|NCT01133002|"~     Primary Objective:~      - To obtain prospective, clinical practice-based data on how symptomatic VTE is managed with~     low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings.~      Secondary Objective:~        -  To describe the demographic and clinical characteristics of patients with symptomatic~          VTE including characteristics of VTE, VTE risk factors and bleeding risk factors.~        -  To assess the frequency of patient characteristics that would necessitate adjustment in~          the dose or duration of enoxaparin therapy, e.g. high BMI, impaired creatinine~          clearance, advanced age, cancer-associated VTE.~        -  To assess the degree of adherence in clinical practice to Consensus Guidelines~          (ACCP/American College of chest Physician 2008) for the management of acute VTE, vis a~          vis:~        -  Appropriate dosing of enoxaparin~        -  Recommended duration of initial LMWH therapy~        -  Adequate overlap of LMWH with vitamin K antagonists (VKA)~        -  Recommended duration of longterm VKA~        -  Frequency of use of LMWH monotherapy to treat cancer-related VTE~        -  To access safety outcomes (including bleeding and recurrent VTE)~        -  To describe the utilization of resources due to bleeding and recurrent VTE during the~          treatment period.~   "
185774|NCT01132989|"~     Patients with cutaneous T cell lymphoma experience refractory and progressive disease despite~     current treatment, necessitating chronic disease management. In addition, there needs to be~     greater emphasis on combination treatment, which correlates with increased response rate,~     more rapid onset of response, and decreased side effect profile compared to monotherapy. The~     goal for the use of Lenalidomide as an adjuvant treatment in patients with refractory~     cutaneous T cell lymphoma is to increase response rates, maintain a durable long-term~     response, relieve associated symptoms, and minimize toxic side effects.~   "
185775|NCT01132976|"~     Services for people with personality disorders are challenged by how to engage clients in~     therapy. High non-completion rates have major cost-efficiency implications, but more worrying~     is that drop-out may be associated with negative outcomes for clients. The investigators have~     developed a motivational intervention that helps people focus on their valued and attainable~     life goals and consider how therapy could help with goal attainment.One way to improve~     retention in treatment is to deliver pre-therapy motivational preparation interviews. The~     primary aim of our proposed research is to gather information to determine whether a~     randomised controlled trial of a goal-based motivational intervention is feasible in a~     community personality disorder treatment service.~   "
185776|NCT01132963|"~     The study aims to assess whether type of footwear worn changes the balance, mobility and~     confidence of older inpatients and consequently may affect their falls risk whilst in~     hospital. The investigators hope to identify which footwear type is most beneficial to~     patients in the ward environment.~   "
185777|NCT01132950|"~     The purpose of this study is to increase the initiation and continuation of highly effective~     contraceptive use while incarcerated and upon release, as well as decrease unsafe sexual~     activity.~   "
185806|NCT01132573|"~     This phase I trial studies the side effects and best dose of entinostat when given together~     with clofarabine in treating patients with newly diagnosed, relapsed, or refractory poor-risk~     acute lymphoblastic leukemia or bilineage/biphenotypic leukemia. Entinostat may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving entinostat with~     clofarabine may kill more cancer cells.~   "
185778|NCT01132937|"~     Background:~      - Traumatic brain injury may have a range of effects, from severe and permanent disability to~     more subtle functional and cognitive deficits that often go undetected during initial~     treatment. To improve treatments and therapies and to provide a uniform quality of care,~     researchers are interested in developing more standardized criteria for diagnosing and~     classifying different types of traumatic brain injury. By identifying imaging and other~     indicators immediately after the injury and during the initial treatment phrase, researchers~     hope to better understand the nature and effects of acute traumatic brain injury.~      Objectives:~        -  To study the MRI results of individuals who have recently had head injury and suspected~          traumatic brain injury.~        -  To study the natural evolution of traumatic brain injury for up to 3 months after head~          injury.~      Eligibility:~      - Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed~     or suspected traumatic brain injury within the past 48 hours.~      Design:~        -  Participants will have one 3-hour study visits: an initial visit (within 48 hours of~          head injury). Participants may be asked to have an optional 4-day, 30-day, 90-day, and~          1-year follow-up.~        -  Each visit may involve blood samples, an MRI scan (approximately 30 minutes), and a~          series of tests to evaluate brain function.~        -  At the optional follow-up visit, participants may have blood samples, an MRI scan, and a~          general traumatic brain injury assessment.~        -  This study does not provide treatment and does not replace any current therapies.~          However, participants who are eligible for other National Institutes of Health studies~          may be referred to these studies by researchers.~   "
185779|NCT01132924|"~     Background:~      - The purpose of the 1982 1986 North Carolina Early Pregnancy Study was to determine how~     often pregnancy loss occurs before women know they are pregnant. Women planning to become~     pregnant were asked to collect daily urine specimens and fill out daily diaries of their~     intercourse and menstrual bleeding. Researchers are interested in re-contacting this cohort~     to gather new information and to examine how accurately women can recall events that occurred~     earlier in their lives.~      Objectives:~      - To follow-up with and gather additional information from women who were involved in the~     Early Pregnancy Study.~      Eligibility:~      - Women who participated in the 1982 1986 North Carolina Early Pregnancy Study.~      Design:~        -  Participants will receive and complete a questionnaire that includes the following~          topics:~        -  Their pregnancy history.~        -  The infant s birth, including method of delivery and induction of labor.~        -  Early life exposures such as their own birth weight and their parents ages at their~          birth.~        -  Tap water use during their attempt to conceive~        -  General description of their behaviors during their participation in the original study,~          these include: physical activity, caffeine, alcohol, and soy food consumption.~        -  Participants will return the surveys to the researchers in the stamped envelope provided~          with the questionnaire.~   "
185780|NCT01132911|"~     Background:~      - Vorinostat and bortezomib are anti-tumor drugs that have been approved by the Food and Drug~     Administration to treat different kinds of myeloma and lymphoma in adults. The combination of~     these two drugs has been tried in a small number of adults, but it has not been formally~     approved and is experimental, particularly in children. Researchers are interested in~     determining safe and effective treatment doses of vorinostat and bortezomib in children, and~     learning more about how these drugs affect tumor growth and human development.~      Objectives:~        -  To determine safe and effective doses of vorinostat and bortezomib to treat solid tumors~          in children.~        -  To study the effects of vorinostat and bortezomib on blood cells, blood flow, and human~          development.~      Eligibility:~      - Children, adolescents, and young adults between 1 and 21 years of age who have been~     diagnosed with solid tumors that have not responded to treatment.~      Design:~        -  Eligible participants will be screened with a physical examination, blood and tumor~          samples, and imaging studies.~        -  Participants will have 21-day treatment cycles of vorinostat and bortezomib. Vorinostat~          will be given as either tablets or liquid doses on days 1 through 5 and 8 through 12 of~          each cycle. Bortezomib will be given as an intravenous injection on days 1, 4, 8, and 11~          of each cycle. Participants will keep a drug administration diary to record information~          about side effects or other problems with the treatment.~        -  Participants may continue to receive vorinostat and bortezomib for up to 2 years unless~          serious side effects develop or the tumor does not respond to treatment.~        -  Additional blood samples will be taken at regular intervals for the first 3 days after~          the first bortezomib dose and for the first 2 days after the first vorinostat dose of~          the first treatment cycle.~   "
185781|NCT01132898|"~     Background:~      - Traumatic brain injury may have a range of effects, from severe and permanent disability to~     more subtle functional and cognitive deficits that often go undetected during initial~     treatment. To improve treatments and therapies and to provide a uniform quality of care,~     researchers are interested in developing more standardized criteria for diagnosing and~     classifying different types of traumatic brain injury. By identifying imaging and other~     indicators immediately after the injury and during the initial treatment phrase, researchers~     hope to better understand the nature and effects of acute traumatic brain injury.~      Objectives:~      - To study the natural history of traumatic brain injury by examining the changes in brain~     scans, blood samples, and brain function over 5 years after a the injury.~      Eligibility:~      - Individuals between 18 and 70 years of age who have had a traumatic brain injury within the~     past 6 months.~      Design:~        -  This study will include about eight visits to the NIH Clinical Center over 5 years.~          Participants will have four visits in the first year, and one visit each year for the~          following 4 years. Each visit will take between 1 and 4 days, and participants will be~          in the outpatient clinic for about 8 hours each day of the visit.~        -  At each study visit, participants will have some or all of the following tests:~        -  Medical history and physical examination~        -  Blood and urine tests~        -  Questionnaires and assessments of thinking and memory, which may be spoken aloud,~          written down, or entered into a computer~        -  Imaging scans, such as magnetic resonance imaging (MRI) or positron emission~          tomography/computed tomography (PET/CT).~        -  This study does not provide treatment and does not replace any current therapies.~          However, participants who are eligible for other National Institutes of Health studies~          may be referred to these studies by researchers.~   "
185790|NCT01132781|"~     Allergic rhinitis and asthma are common respiratory diseases, which often coexist. The~     prevalence of allergic rhinitis in subjects with asthma is up to 80%, and the prevalence of~     asthma is 3-5 times greater in subjects with rhinitis than healthy controls. The mechanisms~     of the allergen response in both diseases are parallel to each other, with similar mediator~     and cellular responses to similar allergens. These observations have led to the suggestion~     that both diseases are different expressions of one airway disease.We wish to evaluate the~     effect of low dose theophylline in patients with asthma, given its effects as subtherapeutic~     concentrations and the propensity to develop adverse events at higher doses.~   "
185791|NCT01132768|"~     Effect of olmesartan medoxomil (20-40 mg) on plaque regression in hypertensive patients with~     carotid atherosclerosis.~   "
185807|NCT01132560|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     ductal breast carcinoma in situ.~   "
185808|NCT01132547|"~     RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer~     treatment. It is not yet known whether cyproheptadine is more effective than a placebo in~     preventing weight loss in young patients receiving chemotherapy for cancer.~      PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how~     well it works in preventing weight loss in young patients receiving chemotherapy for cancer.~   "
185782|NCT01132885|"~     Background:~      - Little is known about how the brain changes during childhood and adolescence, how genes~     affect this process, or how the brains of people with Williams syndrome change during this~     period. Genetic features of Williams syndrome affect the brain s development, but the details~     of this process have not been studied over time. Researchers are interested in using magnetic~     resonance imaging to study how the brain changes in healthy children and children with~     Williams syndrome and related genetic disorders.~      Objectives:~      - To study developmental changes in the brains of healthy children and children who have been~     diagnosed with Williams syndrome or a related genetic disorder.~      Eligibility:~        -  Healthy children and adolescents between 5 and 17 years of age.~        -  Children and adolescents between 5 and 17 years of age who have been diagnosed with~          Williams syndrome or genetic characteristics that overlap with Williams syndrome.~      Design:~        -  Participants will have a brief physical examination and tests of memory, attention,~          concentration, and thinking. Parents will be asked about their child s personality,~          behavior characteristics, and social interaction and communication skills.~        -  Both participants and their parents may be asked to complete additional questionnaires~          or take various tests as required for the study.~        -  Participants will have approximately 10 hours of magnetic resonance imaging (MRI)~          scanning, usually over 4 to 5 days, within a one month period. Some of these tests will~          require the participants to do specific tasks while inside the MRI scanner.~        -  Participants will be asked to return to the National Institutes of Health clinical~          center to repeat these procedures every 2 years thereafter until age 18.~   "
185783|NCT01132872|"~     Background:~        -  Researchers studying new treatments for major depressive disorder are looking at how~          medications to treat depression act on the brain chemical serotonin, which interacts~          with specific serotonin receptors on brain cells. New methods of studying serotonin~          receptors in the brain may help provide a better understanding of depression and~          treatment options.~        -  A new radioactive chemical called [11C]CUMI may be useful for studying serotonin~          receptors in the brain. By using positron emission tomography (PET) scanning to see how~          [11C]CUMI bonds with serotonin receptors, researchers will investigate whether [11C]CUMI~          can be used to study depression and how antidepressant medications work.~      Objectives:~      - To determine the usefulness of [11C]CUMI as a method of studying serotonin receptors in the~     brain.~      Eligibility:~      - Healthy individuals between 18 and 65 who have no history of psychiatric illness.~      Design:~        -  This study requires 8 outpatient visits to the NIH clinic.~        -  Visit 1: Participants will have a full physical examination and medical history, as well~          as a psychiatric evaluation and questions about alcohol and drug use. Other tests will~          include blood and urine samples and an electrocardiogram (EKG). Testing will take~          approximately 3 hours.~        -  Visit 2: Participants will have a magnetic resonance imaging (MRI) scan to evaluate~          brain function and activity.~        -  Visit 3: Participants will have a PET scan, in which a small amount of the radioactive~          chemical [11C]CUMI will be injected through an intravenous (IV) catheter, and will have~          another IV line put in place to draw regular blood samples during the scan. The scan~          will last approximately 4 hours.~        -  Visits 4-8: Participants will have regular blood tests after the scan between days 1-3~          and at about weeks 1, 2, 3, and 4. The blood tests will check muscle, heart, and liver~          function.~   "
185784|NCT01132859|"~     Background:~      - The Vaccine Research Center (VRC) is dedicated to understanding immune responses associated~     with prevention and treatment of infectious diseases. To study these immune responses,~     researchers need to collect specimens and images from individuals who have recently had a~     vaccination or recovered from an infection. These specimens and images are used to study~     different diseases and immune responses, and can be used to investigate ways to prevent or~     treat different medical conditions.~      Objectives:~      - To evaluate blood and other tissue samples for immune responses to vaccines and natural~     infections.~      Eligibility:~      - Healthy volunteers at least 18 years of age who agree to donate specimens for research~     purposes.~      Design:~        -  Participants will have clinical evaluations and will be asked to provide some of the~          following samples, depending on the research question being addressed. All procedures~          and sample donations are optional and voluntary:~        -  Blood samples through regular blood draws (for whole blood) and apheresis (to collect~          specific parts of the blood such as plasma or white blood cells)~        -  Urine, semen, saliva, or vaginal swab samples~        -  Tissue samples or biopsy specimens~        -  Undergo procedures such as bronchoscopy (lung and respiratory tract), gastrointestinal~          endoscopy (stomach and upper intestinal tract), or colonoscopy (lower intestinal tract)~          to obtain tissue samples~        -  Undergo imaging studies such as positron emission tomography (PET) or computed~          tomography (CT) scans~      Duration of participation is variable depending on the research question but will usually~     last up to 1 year.~      - Participants will be compensated for participation.~   "
185785|NCT01132846|"~     The purpose of this study is to determine the benefits and safety of intravenous~     administration of low dose nesiritide or low dose dopamine in patients with congestive heart~     failure and kidney dysfunction. There is a substudy in a subset of subjects that is being~     used to determine whether the Provocative Dyspnea Severity Score (pDSS) is a more sensitive~     index of variability in clinical status than the dyspnea VAS assessed without standardization~     of conditions at assessments.~   "
185786|NCT01132833|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy~     may help doctors learn more about the effects of chemotherapy on cells. It may also help~     doctors understand how patients respond to treatment.~      PURPOSE: This research study is studying biomarkers related to thrombosis in patients with~     newly diagnosed multiple myeloma receiving chemotherapy.~   "
185787|NCT01132820|"~     This phase II trial studies the side effects and how well cediranib maleate works in treating~     patients with endometrial cancer that has failed to respond to initial chemotherapy or has~     come back after surgery, radiation therapy, or other forms of treatment. Cediranib maleate~     may stop the growth of tumor cells by blocking proteins made by tumors that can stimulate~     growth of tumor cells as well as blood vessels in and around tumors.~   "
185788|NCT01132807|"~     This phase II trial studies how well chemotherapy based on positron emission tomography (PET)~     scan works in treating patients with stage I or stage II Hodgkin lymphoma. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells.~     Giving combination chemotherapy together with radiation therapy may kill more cancer cells~     and allow doctors to save the part of the body where the cancer started. Comparing results of~     diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help~     doctors predict a patient's response to treatment and help plan the best treatment.~   "
185789|NCT01132794|"~     Dental procedures such as wisdom tooth removal evoke very high levels of patients' anxiety~     and it is, therefore, common practice to provide concomitant pharmacologic sedation.~      Sedative agents can be administered by the oral, rectal, intra muscular and intravenous~     routes. The oldest, safest and most convenient route at present is the oral route. However,~     as Uygur-Bayramicli et al. mentioned that administering the drugs orally can result in~     problems like delayed effect. Intranasal administration is a straightforward procedure. It is~     simple and relatively painless. Although it may be objectionable, less patient cooperation is~     required than with oral administration, especially in which the child must swallow the~     medication.~      Many studies on dental sedation have been carried out by anesthesiologists but there is no~     ideal drug that can offer effects of both sedation and analgesia. Some drugs offer only one~     effect and others are not safe enough for clinical use. Midazolam, a benzodiazepine drug, is~     the traditional choice for sedation, but it has properties such as relatively slow onset and~     no analgesia. Propofol is an alkylphenol sedative and hypnotic agent with a rapid onset and~     offset. It has been used in patient controlled sedation before. But it has no analgesic~     properties. It can provide some antegrade amnesia, but it is not as reliable an amnestic as~     the benzodiazepine drugs. Because of these characteristics, propofol often is supplemented~     with narcotics and benzodiazepines. Although not irritant, it can cause pain during~     intravenous infusion.~      A new drug, an alpha agonist with its relatively high ratio of α2/α1-activity (1620:1 as~     compared with 220:1 for clonidine) of theα2 receptor is dexmedetomidine. This property may~     lead to more potent effects of both sedation and analgesia without unwanted cardiovascular~     effects fromα1 receptor activation. Most of the data evaluating the use of dexmedetomidine in~     the intensive care unit (ICU) were obtained in the immediate postoperative period, mainly in~     patients who underwent open-heart surgery. Currently, clinicians are awaiting studies in~     broader patient populations. In the studies that have been completed to date, sedation has~     been attained easily with maintenance of respiratory function. Patients are readily~     arousable. There is a minimal increase in blood pressure initially, followed by a slight~     decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow~     rate of administration tend to decrease these circulatory side effects. So many clinical~     studies have shown that it can be well and safely used intravenously, intramuscularly and~     transdermally. Although not an officially technique, there are also reports of intranasal~     administration resulting in fairly predictable onset in both adults and children.~      The investigators propose that intranasal can help to improve postoperative pain relief with~     better sedation.~   "
185792|NCT01132755|"~     This study is being done to develop a new method that can rapidly stage patients with gastric~     and pancreas cancer. Staging means finding out what is the extent of the cancer in a~     patient's body.~      Currently before patients have the surgery to remove their cancer, a surgical exam is done in~     the operating room to see if their cancer has spread. A thin tube-like instrument with lens~     and a light is placed into the abdomen. This is done by making small cuts into the body. This~     exam is called a diagnostic laparoscopy. If cancer spread is not seen, fluid is put into the~     abdomen and then taken out. This is called lavage or washing. The fluid is then looked at~     in a laboratory. If the fluid contains cancer cells surgery is often delayed.~      The investigators are testing a new method to put the fluid into the abdomen. It is called~     percutaneous lavage. Percutaneous means through the skin. A needle is put through the skin~     into the abdomen. Tubing is then placed over the needle so that fluid can be put into the~     abdomen and then taken out. The fluid is then looked at in a laboratory. The investigators~     want to see if the two methods are equal because if they are equal, in the future, patients~     may be able to have this procedure done outside of the operating room.~   "
185793|NCT01132742|"~     Malnutrition in children has even more severe consequences on disease course and long-term~     health than malnutrition in adults. According to prior studies, malnutrition affects about~     15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and~     Hulst 2008). However, available criteria for defining malnutrition in paediatric patients are~     inconsistent, not based on firm evidence, and not generally agreed upon. Current guidelines~     do not address assessment of and screening for childhood malnutrition. Therefore, a large~     number of affected children are not adequately diagnosed.~      One aim of this study is to assess the prevalence of malnutrition and patients at risk for~     malnutrition among at least 2700 hospitalized children mainly across Europe. In addition~     criteria to link anthropometric measurements and the prediction of outcome, i.e. length of~     hospital stay, shall be established. A further goal then is to establish agreed,~     evidence-based criteria for malnutrition in children with the purpose of leading to an~     agreed, evidence-based screening tool for paediatric malnutrition in developed countries.~     This tool shall include a set of simple questions, based on previously suggested tools.~     Thereby this study will provide a strong basis for implementing evidence-based nutritional~     interventions in paediatric patients by harmonisation of diagnostic criteria for childhood~     malnutrition in developed countries.~   "
185794|NCT01132729|"~     The objective of this study was to prove the bioequivalence of Valacyclovir~     Hydrochlorothiazide Caplet under fasting conditions.~   "
185795|NCT01132716|"~     The objective of this study was to prove the bioequivalence of Valacyclovir~     Hydrochlorothiazide Caplet under fed conditions.~   "
185796|NCT01132703|"~     The primary objective of this study is to evaluate the safety and tolerability of RP-1127~     (glyburide for injection), administered as a bolus dose followed by a 3 day continuous~     infusion. The secondary objectives are to assess the pharmacokinetics of RP-1127 and blood~     glucose and serum insulin PD responses to RP-1127.~   "
185797|NCT01132690|"~     This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase~     alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to~     treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV)~     infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12~     months. At the end of the 12-month treatment period eligible subjects will be offered~     enrollment in an open-label extension study if taliglucerase alfa is not commercially~     available.~   "
185798|NCT01132677|"~     Do differences exist between patients who receive a single intra-articular injection of~     corticosteroid versus patients who receive a single intra-articular injection of hyaluronic~     acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post~     injection?~   "
185799|NCT01132664|"~     This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in~     patients with relapsing HER2 overexpressing breast cancer who have previously failed~     trastuzumab.~      The study will further assess the safety and preliminary efficacy of BKM120 in combination~     with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast~     cancer and brain metastases (BM) who have previously failed trastuzumab.~   "
185800|NCT01132651|"~     The purpose of this study is to see if using a cooling pillow at night will help sleep~     quality in people with atopic dermatitis (AD).~   "
185801|NCT01132638|"~     The aim of this trial is to evaluate the complete remission of erosive gastroesophageal~     reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once~     daily during four-week treatment with an extension treatment for non-responding patients. The~     study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28~     -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux.~     The study will provide further data on safety and tolerability of pantoprazole magnesium.~   "
185802|NCT01132625|"~     This study will characterize the safety, tolerability, efficacy, pharmacokinetics, and~     pharmacodynamics of AUY922 in adult patients with advanced solid malignancies in Japan.~   "
185803|NCT01132612|"~     The purpose of this study was to provide long term clinical data for the compound for the~     treatment of the indication of moderate to severe chronic plaque-type psoriasis.~   "
185804|NCT01132599|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) and computed~     tomography (CT) imaging, may help find and diagnose metastatic prostate cancer.~      PURPOSE: This phase II trial is studying the side effects of C-11 choline and~     18F-fluoromethylcholine and to see how well they work when used in PET and CT imaging in~     patients with metastatic prostate cancer.~   "
185805|NCT01132586|"~     This phase I trial studies the side effects and best dose of lenalidomide when given together~     with cytarabine and idarubicin in treating patients with acute myeloid leukemia. Biological~     therapies, such as lenalidomide, may stimulate the immune system in different ways and stop~     cancer cells from growing. Drugs used in chemotherapy, such as cytarabine and idarubicin,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving lenalidomide together with cytarabine and idarubicin may~     kill more cancer cells.~   "
188196|NCT01101204|"~     The study is planned to show whether combined hypolipemic and antidiabetic therapy with~     various daily dosages influence the fasting plasma glucose, insulin sensitivity and~     proinflammatory cytokines in diabetic and dyslipidemic subjects.~   "
185809|NCT01132534|"~     Videoendoscopy is the standard tool for examination of gastrointestinal tract. However,~     precancerous lesions and early gastric cancer can be easily missed by routine videoendoscopy.~     Autofluorescence Imaging (AFI) and Narrow band imaging (NBI) are 2 new imaging systems used~     in endoscopy which are recently developed. AFI based on the presence of natural tissue~     fluorescence on the gastrointestinal tract. By computation of the difference in the~     reflecting images, the system can reveal early cancers that are not detectable by standard~     endoscopy. NBI is a high resolution imaging using lights with narrowed wavelength range,~     which able to enhance the fine structure of the mucosa. Recent studies suggested combined AFI~     and NBI can improve the detection of early esophageal and gastric cancers.~      The investigators are conducting a prospective randomized cross-over study to compare the~     accuracy between this combined AFI/NBI imaging with standard videoendoscopy in the detection~     of precancerous lesions and gastric cancer in a high risk population inSingapore. The~     investigators hypothesis is that this new combined imaging system improves the investigators~     detection of high risk lesions of stomach.~   "
185810|NCT01132521|"~     This study aims to evaluate the effect of ulinastatin in the treatment and prevention of~     organ failure in severe acute pancreatitis.~   "
185811|NCT01132508|"~     Case series of tibial plateau fractures using Norian Drillable.~   "
185812|NCT01132495|"~     The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and~     cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in~     patients with stable coronary artery disease.~   "
185813|NCT01132482|"~     Dehydrated airway surfaces resulting from sodium hyperabsorption and lack of chloride~     secretion are critical to the pathology that leads to the morbidity and mortality from Cystic~     Fibrosis (CF) lung disease. Previously published work in CF cell lines has demonstrated that~     by increasing cGMP and restoring inhibition of ENaC, sodium hyperabsorption may be reversed~     following administration of a phosphodiesterase inhibitor (PDEi,) such as sildenafil.~     Additionally it has been shown in CF cell lines and animal models, that phosphodiesterase~     inhibitors/analogues can enhance chloride secretion and/or correct surface localization of~     ΔF508 CFTR. The goal of this project is to translate the results of this work from the~     laboratory into a clinical trial in patients with CF using an FDA-approved therapy. The~     Specific Aims of this project are to: 1) Evaluate the effect of systemically administered~     phosphodiesterase inhibitors on ion transport in CF by measurement of Na+ and Cl- conductance~     by NPD and Na+ and Cl- concentration in sweat utilizing pilocarpine iontophoresis 2) To~     establish appropriate dosing of sildenafil in CF by performing a dose-escalation study during~     which patients are carefully monitored for side effects, plasma sildenafil levels are~     obtained and outcome measures are compared based on the dose of sildenafil administered. The~     results of this study in conjunction with those from an ongoing study examining the role of~     sildenafil as an anti-inflammatory in CF will aid in establishing safety, pharmacokinetics~     and mechanism of action of sildenafil in the treatment of CF lung disease.~   "
185814|NCT01132469|"~     The purpose of this study is to evaluate the safety and clinical effectiveness of~     ESD(Endoscopic Submucosal Dissection) for early gastric cancer analyzing short-term and~     long-term results of endoscopic treatment.~   "
185815|NCT01132456|"~     The purpose of this study is to document the safety and overall clinical performance of the~     Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a patient population with long~     lesion(s) and/or dual vessels requiring stent implantation.~   "
185816|NCT01132443|"~     This study was conducted to determine if the bioavailability of clindamycin and its~     metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of~     methylparaben. This study compared the investigational study product and 2 marketed products:~        -  CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free~        -  Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP)~        -  Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)~   "
185817|NCT01132430|"~     The high burden of asthma appears to be related to poor asthma control, which is associated~     with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and~     worse pulmonary function. Despite the availability of effective treatments, more than 58% of~     asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS) regimens is~     considered by experts to be one of the most important behavioral factors linked to achieving~     optimal asthma control. However, there is a paucity of research on interventions specifically~     designed to improve ICS adherence among adult asthmatics. The vast majority of intervention~     studies to date used atheoretical interventions to target behavior change, relying mainly~     upon educational approaches which have been criticised for failing to translate knowledge~     into action. This may be due to the fact that most education-based approaches do not~     specifically address or help patients overcome ambivalence about behavior change, which is~     necessary for ensuring daily adherence. Motivational interviewing (MI) is a client-centred~     intervention that focuses on enhancing intrinsic motivation to change a particular behavior,~     and exploring and resolving ambivalence about behavior change. Brief MI sessions (e.g., 1-5 x~     15-30 minute sessions) have been shown to improve a variety of health behaviors (e.g., reduce~     alcohol consumption, improve dietary habits, increase exercise behaviour, and improve~     medication adherence) and health outcomes (reduce blood pressure, body mass index, and~     cholesterol levels). However, no studies to date have assessed the efficacy of using MI to~     improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MI to~     improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent~     asthmatics. It is hypothesized that patients randomized to the MI condition will exhibit~     significantly improved ICS adherence at 6 and 12-months post-intervention, independent of~     baseline levels and covariates, relative to patients randomized to the usual care control~     condition.~   "
185818|NCT01132417|"~     Observational: studies in human beings in which biomedical and/or health outcomes are~     assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic,~     therapeutic, or other interventions, but the investigator does not assign specific~     interventions to the subjects of the study.~   "
185819|NCT01132404|"~     The phase 1 portion of this study is an open-label, multicenter, dose-escalation study of~     1-month depot TAK-448 in adult males with prostate cancer who are either on gonadotropin~     releasing hormone (GnRH) therapy or who might be eligible for GnRH therapy in the future. The~     phase 2 portion of this study is an open-label, multicenter, randomized study in men with~     prostate cancer that will confirm the testosterone- and prostate specific antigen (PSA)-~     lowering potential of up to 2 dose levels of 1-month depot TAK-448.~   "
185859|NCT01131884|"~     Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in~     acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry~     (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months~     and be required to take oral fosamax versus placebo weekly.~   "
188197|NCT01101191|"~     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80~     mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.~   "
185820|NCT01132391|"~     Perianal topical nitroglycerin has been widely used as a means for avoiding surgery in~     patients with anal fissure. However, nitroglycerin has not been universally accepted for this~     application because of inconsistency of efficacy and side effects. Recent studies (Dis Colon~     Rectum. 2007 Apr;50(4):509-16) have demonstrated that nitroglycerin ointment products~     compounded by pharmacies did not meet the USP specifications for potency and/or content~     uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results~     raise significant issues as to whether the patient is put at undue risk relative to the~     relief of their anal fissure pain. In addition, one study (Dis Colon Rectum. 2006~     Jun;49(6):865-8) has demonstrated that intra-anal dosing of topical nitroglycerin produces a~     significantly greater reduction in sphincteric pressure and lower incidence of headaches than~     with perianal administration of the same dose of ointment.~      Topical glyceryl trinitrate 0.4% ointment has been developed and tested in clinical trials~     and is effective in healing chronic anal fissures. It assures exactly dose and concentration~     of nitroglycerin.~      Hypothesis: The endoanal application of exactly dose and concentration of nitroglycerin must~     reduced headache and the final recurrence.~      The purpose of this study is:~      1. Principal end-point: to compare perianal vs endoanal application of Rectogesic and~     evaluate the different morbidity of the two presentation~   "
185821|NCT01132378|"~     The purpose of this study is to compare two different surgical approaches for total knee~     replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle~     (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the~     knee components. Both will have the same skin incision.~   "
185822|NCT01132365|"~     Objective~      Describe the clinical and demographic characteristics of patients who undergo knee~     arthroplasty and document post operative outcomes.~      Examine the relationship between processes of care, hospital and surgeon associated outcomes.~      Provide expanded data to characterize existing and evolving practice patterns, delivery of~     care, and resource utilization in the management of knee arthroplasty patients.~      Analyze and design ancillary studies to address unanswered questions.~      Disseminate findings through publication in peer-reviewed scientific journals.~   "
185823|NCT01132352|"~     The purpose of this study is to compare the single-dose relative bioavailability study of~     Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under fed conditions.~   "
185824|NCT01132339|"~     Rationale:~      Contrast agents are important tools for MR/CT- examinations, when it comes to diagnosing~     diseases. But despite their frequent use in Denmark, they are not free of serious and~     potentially fatal adverse reactions. Examples of this are contrast-induced nephropathy (CIN)~     and nephrogenic systemic fibrosis (NSF). Therefore, it is extremely important to clarify if~     these adverse reactions are actually directly related to the use of contrast agents or to~     MR/CT- examinations.~      Objective:~      To prospectively assess the incidence of adverse reactions of iodine-containing CT and~     gadolinium- based MR contrast agents in a prospective design. A control group examined~     without the use of contrast agent will be included, so that the study can illuminate reported~     adverse events related to contrast agents and CT/MR- examinations. This project will in the~     long term mean that, any significant and life-threatening delayed adverse reactions will be~     discovered earlier and hence it will be more likely to treat the patients in good time for~     these adverse reactions.~      The following series of hypotheses will be investigated in this study:~        1. Renal as well as non-renal adverse reactions occurring are related to the use of~          contrast agent in MR-/CT-examination.~        2. CIN occurs in patients undergoing a MR-/CT-examination with contrast agent.~      Methods:~      Approvals are obtained from The Copenhagen County Committee on Biomedical Research Ethics and~     Danish Data Protection Agency. A total of 1600 patients will be included from Department of~     Radiology at Herlev Hospital, where all the MR- and CT examinations will be performed.~     Patients will be divided into four groups (a, b, c and d) with 400 patients in each group.~     Group a and c (case group) undergo respectively MR and CT examination with contrast agent~     While group b and d (control group) will undergo respectively MR and CT examination without~     the use of contrast agent. For each patient the following will be recorded: Risk factors,~     renal function (eGFR) before and 72 hours after MR/CT- examination as well as the incidence~     of immediate reactions (within 30 min.). Furthermore, patients have to answer a questionnaire~     72 hours and 1 month after MR/CT- examination about the severity and frequency of adverse~     reactions to contrast media.~   "
185825|NCT01132326|"~     Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of~     norepinephrine depletion leading to a diminished capacity to effect an appropriate~     cardiovascular response to an orthostatic challenge resulting in symptomatic~     cerebral-hypoperfusion. Droxidopa augments norepinephrine levels which should lead to~     improved cerebral perfusion following orthostatic challenge thereby reducing the symptoms of~     NOH. The present study will evaluate the long-term safety of droxidopa.~   "
185826|NCT01132313|"~     The substances BI 201335 and BI 207127 are being developed for the treatment of chronic~     hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from~     replicating.~      The currently available medications pegylated interferon alfa and ribavirin for hepatitis C~     ca have considerable adverse events in patients and in many cases are not sufficiently~     effective. This is particularly the case in treatment of patients infected with genotype 1 of~     HCV.~      A combination therapy of these new substances without pegylated interferon alfa may be~     associated with fewer adverse events that currently available (pegylated~     interferon-alfa-based) medication and may also provide a treatment option to the large number~     of patients with contraindications or intolerance to pegylated interferon alfa.~      This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and~     Part 3.~      Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual~     enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as~     described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated:~     362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83~     patients randomized and treated)~   "
185827|NCT01132300|"~     The purpose of this study is:~        -  Initial evaluation of the clinical effectiveness of Image Guided Transcutaneous~          Electrical Stimulation (TENS) device for treatment of non-specific low back pain.~        -  To assess the tolerability and acceptability of the device by the caregiver (User~          Friendly).~        -  To evaluate patients' tolerance by monitoring side effects and tolerability during~          treatment.~   "
185828|NCT01132287|"~     Study to evaluate subjective comfort associated with the use of a marketed lubricant eye~     drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily~     disposable replacement schedule.~   "
185887|NCT01131520|"~     The purpose of this study is to compare the effectiveness in reducing drug use and its~     associated problems of a brief intervention for drug use delivered by a behavioral health~     counselor as compared to a brief intervention delivered by a computerized intervention.~   "
185888|NCT01131507|"~     A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008)~     3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine~     pancreatic insufficiency (EPI) due to cystic fibrosis (CF).~   "
185829|NCT01132274|"~     Radiofrequency catheter ablation (RFCA) is the mainstay of therapy for supraventricular~     tachyarrhythmias, providing cure in a high percentage of cases. Conventional ablation~     techniques require the use of fluoroscopy to place and navigate catheters in the heart, thus~     exposing patients to ionizing radiations with an additional risk of cancer. The feasibility~     and safety of a non-fluoroscopic RFCA of a wide range of supraventricular arrhythmias using~     the EnSite NavX mapping system have been recently reported. The NO-PARTY is a multicenter,~     randomized-controlled trial designed to test the hypothesis that supraventricular arrhythmias~     RFCA through the non-fluoroscopic EnSite NavX mapping system results in a clinically~     significant reduction of the exposure to ionizing radiations compared with conventional~     ablation techniques.~      NO-PARTY trial will determine whether supraventricular tachyarrhythmia RFCA through a~     non-fluoroscopic EnSite NavX mapping system is a suitable and cost-effective approach to~     achieve a clinically significant reduction of ionizing radiation exposure for both the~     patient and the operator.~   "
185830|NCT01132261|"~     Dementia is a major cause of disabilities in older people. If the onset of dementia can be~     delayed by preventive measures, the burden of the disease to the society can be greatly~     reduced. It is now recognised that dietary factors are related to the incidence of dementia.~     High intake of vegetables, fruit and fish are protective while high intake of saturated fat~     and salt (via its effect on blood pressure) are detrimental to risk of dementia.~      The investigators therefore propose to perform a randomized controlled trial of dietetic~     interventions in old age hostels in Hong Kong. Twelve old age hostels under the Tung Wah~     Group will be randomly assigned to intervention or control groups. The intervention group~     will receive dietetic interventions by 2 weekly small group discussion with the residents,~     modification of menu and publicity. The daily diet to be implemented consists of the~     following principles: 1. fresh fruit 2 portions, 2. vegetables 4 portions, 3. fish, 4. white~     meat, 5. sodium intake < 100 mmol/L, 6. six glasses of water. In the control group. The~     dietician will give two health talks and advice on menu only.~      The primary outcome is the incidence of questionable dementia in those who are normal at~     baseline and the incidence of dementia in those who have questionable dementia at baseline.~     The categorisation will be performed by trained research assistant after administering a~     structured questionnaire. Change in mini-mental examination score and SF36 quality of life~     scores are secondary outcomes. Food records over three days for each subject are recorded~     every three months, to ensure that the brain preservation diet has been adhered to. Half of~     the subjects will be randomly assigned to have blood and urine tests at baseline and at one~     year, in order to examine the health effects of dieting.~   "
185831|NCT01132248|"~     Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are~     frequently suffering from this condition. Mefloquine is currently investigated as preventive~     treatment against malaria in pregnancy and mefloquine is also known to exert activity against~     schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active~     against urinary schistosomiasis when used as preventive treatment against malaria in~     pregnancy.~   "
185832|NCT01132235|"~     The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg~     subcutaneous injections twice weekly for 12 weeks in subjects who have previously been~     treated etanercept and efficacy diminished.~   "
185833|NCT01132222|"~     The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg +~     Pseudoephedrine HCL 30 mg under fed conditions.~   "
185834|NCT01132209|"~     The objective of the study is reduction of the incidence of the most frequent complication of~     abdominal surgery, incisional hernia. In this multi center double-blinded prospective~     randomized controlled trial, in which a new suture technique using small bites is compared~     with the traditionally applied large bites (mass closure) technique for midline incisions.~   "
185835|NCT01132196|"~     The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets~     500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy~     subjects.~   "
185836|NCT01132183|"~     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,~     crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with~     Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.~   "
185837|NCT01132170|"~     The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets~     500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy~     subjects.~   "
185838|NCT01132157|"~     Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute~     renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al.~     described the phenomenon ischemic preconditioning. Also, it was reported that a few~     non-ischemic stimuli could provide cellular tolerance against major ischemia through a~     mechanism similar to ischemic preconditioning. In an animal study, 1 minimal alveolar~     concentration of volatile anesthetics - a clinically relevant concentration - was reported to~     have a protective effect against ischemia/reperfusion injury, the effect being variable~     between types of anesthetics. Also, there were somm reports that intravenous anesthetics such~     as propofol could reduce IR injury by decreasing oxidative stress and apoptosis.~      By reducing the ischemia/reperfusion injury of the grafted kidney, the morbidity and~     mortality related to renal transplantation can be reduced as well. The objective of this~     study is to find out whether, according to the type of anesthetics (Desflurane vs. Propofol),~     there is a difference in the protective effect against ischemia/reperfusion injury of the~     grafted kidney in patients receiving renal transplantation.~   "
185839|NCT01132144|"~     The objective of this study is to evaluate the effect of endometrial injury performed prior~     ovulation induction for assisted reproductive techniques main outcomes.~   "
185840|NCT01132131|"~     The Emergency Ward Center in Oslo has the last two years used a questionnaire to identify~     patients who qualify for treatment of acute cystitis by the use of a delegation form.~      The aim of the study is to evaluate this practice, the primary objective being to evaluate if~     in a selected patient group the treatment outcome after identifying patients with probable~     acute cystitis by delegation form will be as good or better than the treatment received after~     a regular doctor's consultation.~      The planned study will also investigate which symptoms, signs and laboratory findings that~     coincide with significant bacteruria.~      The reference standard will be a microbiological culture of every patients urine.~   "
185841|NCT01132118|"~     The purpose of this study is to determine whether hydroxychloroquine (HCQ) reduces insulin~     resistance in non-diabetic subjects with rheumatoid arthritis (RA). The investigators will~     conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis~     that HCQ improves insulin sensitivity. The investigators will also use data from the trial to~     identify determinants of insulin resistance in RA. The investigators hypothesize that RA will~     be associated with an increased risk of insulin resistance and that independent risk factors~     for increased insulin resistance in RA include higher BMI, elevated acute phase reactants,~     greater fat to muscle ratio, and less physical activity.~   "
185842|NCT01132105|"~     The bioelectrical responses of muscle, evoked by sound, obtained with a device considered the~     gold standard (widely used in clinics and hospitals) are similar to those obtained with a new~     device developed~   "
185843|NCT01132092|"~     There are no differences between the exams made with the new device,that evaluates the~     hearing, and the device gold standard, that is widely used in clinics and hospitals.~   "
185844|NCT01132079|"~     This study seeks to investigate the role of pimecrolimus in restoring disturbed skin barrier~     function and reversing epidermal abnormalities found in atopic dermatitis (AD). The project~     is based on findings the investigators presented at the recent SID meeting in Providence and~     published in the J Invest Dermatol (122: 1423-31, 2004). The investigators research shows~     that AD is characterized by impaired skin barrier function, reduced stratum corneum~     hydration, impaired epidermal lipid composition and epidermal differentiation. In this~     proposed project, the investigators wish to examine the influence of pimecrolimus and~     betamethasone valerate on transepidermal water loss (TEWL) as a marker of the skin barrier~     function, on stratum corneum hydration, on stratum corneum lipid content and on epidermal~     differentiation regarding keratins and cornified envelope proteins in AD patients. The study~     involves biophysical measurements of TEWL and skin hydration, lipid analysis,~     immuno-histochemistry, Western blotting and micro array techniques. This study shall clarify~     whether pimecrolimus restores the epidermal barrier and whether this contributes to the~     beneficial effect of pimecrolimus on AD.~      Objectives:~      To explore the stratum corneum hydration, transepidermal water loss, capacity for barrier~     repair and the integrity of the stratum corneum in patients treated with 1 % pimecrolimus~     cream when applied twice a day to atopic dermatitis of the upper limbs, and to access the~     substance's influences on the epidermis through histological, ultra-structural, and~     biochemical analysis using punch biopsies from day 1 of one arm and day 22 from both treated~     arms. 0.1 % betamethasone valerate cream b.i.d will be used as a control treatment.~   "
185845|NCT01132066|"~     The purpose of the research study is to investigate the effect of a brain stimulation~     technique called Transcranial Direct Current Stimulation (TDCS) in improving swallowing~     functions in subjects who develop dysphagia after a unilateral hemispheric infarction.~   "
185846|NCT01132053|"~     This is a continuation of our previous studies on Progressive Multifocal Leukoencephalopathy~     (PML). We will focus on the role of inflammation in PML, and define prognostic markers of~     disease evolution.~   "
185847|NCT01132040|"~     The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of~     Dr.Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, in~     healthy, adult, human subjects under fasting conditions.~   "
185848|NCT01132027|"~     The purpose of this study is to compare the relative bioavailability study of tacrolimus~     capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under non-fasting~     conditions and to monitor safety of subjects.~   "
185849|NCT01132014|"~     This is a Five cohort sequential clinical trial for subjects with recurrent ovarian,~     fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well~     as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells~     (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered~     intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide or in~     combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24~     months.~   "
185850|NCT01132001|"~     This is a prospective study comparing the three blood pressure monitoring methods on the~     diagnosis of arterial hypertension. Blood pressure of each subject will be evaluated with~     clinic, home and 24h ambulatory blood pressure measurements in three visits~   "
185851|NCT01131988|"~     The purpose of this study is to compare the relative bioavailability study of tacrolimus~     capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under fasting~     conditions and to monitor safety of subjects~   "
185852|NCT01131975|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     Lamotrigine formulations after administration of single doses to non-smoking, healthy males~     and females under fed conditions~   "
185853|NCT01131962|"~     Band ligation and injection sclerotherapy are two modalities of treatment that are applied~     using the endoscope. The purpose of this study is to determine which of two methods is better~     for controlling bleeding from the upper gut.~   "
185854|NCT01131949|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     lamotrigine formulations after administration of single doses to non-smoking, healthy~     volunteers under fasted conditions.~   "
185855|NCT01131936|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     amlodipine besylate formulations under fed conditions.~   "
185856|NCT01131923|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     amlodipine besylate formulations under fasting conditions.~   "
185857|NCT01131910|"~     The investigators intend to check whether the efficacy of a TBE-vaccine is substantially~     deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress~     the immune system. The investigators aim to detect a difference of at least 10 % compared to~     healthy individuals (historical controls) in protection when analysed with serology. If the~     investigators detect a difference, the investigators will continue to explore whether~     protection can be achieved by additional doses~   "
185858|NCT01131897|"~     The purpose of this study is to compare the single-dose relative bioavailability study of~     Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under Fasting conditions.~   "
188198|NCT01101178|"~     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80~     mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.~   "
185860|NCT01131871|"~     The prevalence of obesity in young adults has been increasing, and excessive body weight have~     been linked to numerous chronic conditions including cardiovascular disease, diabetes, many~     forms of cancer, and numerous musculoskeletal problems. This study will focus of the~     development and evaluation of interventions that may be appropriate for young adults (age~     18-35 years) to improve weight loss outcomes following a 24 month intervention. The primary~     aim of this study is to examine whether an enhanced weight loss intervention (EWLI) that~     includes technology components results in improved weight loss in young adults (18-35 years~     of age) compared to a standard behavioral weight loss intervention (SBWP) over a period of 24~     months. Eligible participants will also be assessed for body composition, body fat~     distribution, fitness, physical activity, dietary intake, and behavioral/psychosocial~     measures that may be predictive of behavior change. Assessments will occur at 0, 6, 12, 18,~     and 24 months. Subjects will participate in a 24 month behavioral weight loss program that~     includes a reduction in energy intake and moderate-to-vigorous intensity exercise~     (progressively increasing from 100 to 300 minutes per week). The technologies added to EWLI~     are text messaging, a wearable device that provides feedback on physical activity, and access~     to a website to monitor dietary behaviors.~   "
185861|NCT01131858|"~     Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients~     with primary immunodeficiency.~   "
185862|NCT01131845|"~     This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR~     pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end~     stage renal disease (ESRD; on dialysis).~      Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose~     will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis.~      Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6,~     8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with~     ESRD will have a sample taken at 60 hrs post dose.~   "
185863|NCT01131832|"~     The substantial range of individual responsiveness to plant sterols has important~     ramifications. Marked differences across individuals in particular aspects of the cholesterol~     metabolic pathway must alter the impact of plant sterol consumption. As such, a pronounced~     need exists to understand the genetic and metabolic factors that explain the substantial~     degree of heterogeneity in response of lipid concentrations to plant sterols across~     individuals. The primary focus of this trial is to delineate the impact of differing~     cholesterol synthesis levels on response of LDL-C and other plasma lipids to plant sterol~     consumption. Participants pre-identified as high or low endogenous cholesterol synthesizers,~     according to their screening level of lathosterol to cholesterol ratios, will be given PS or~     a placebo containing margarine to consume under supervision for 4 weeks in a crossover~     design. The trial will characterize the responsiveness of the participants' total, LDL, and~     HDL cholesterol, as well as triacylglycerol (TG) concentrations, to plant sterol consumption.~     This research will determine if cholesterol synthesis phenotype predicts the responsiveness~     of lipids to plant sterol consumption. Variations in candidate genes involved in cholesterol~     metabolism will also be investigated in order to find associations with both cholesterol~     metabolism phenotypes and responsiveness of lipids to plant sterols. The output of this~     research will be to advance the knowledge of which genetic factors influence the degree of~     cardiovascular benefit derived from plant sterols through lipid lowering.~   "
185864|NCT01131819|"~     Purpose: The investigators wish to determine if a rehabilitation program for subjects with~     new, trans-tibial amputations that has the balance portion of the program augmented by the~     use of the Nintendo Wii fit ™ balance board improves their performance.~      Hypothesis: The investigators hypothesize that subjects will benefit from the use of the~     device and that this will manifest as an improvement on outcome measures.~   "
185865|NCT01131806|"~     Chronic obstructive pulmonary disease is characterized as inflammatory airway with not fully~     reversible airflow limitation.Combination treatment with inhaled corticosteroid (ICS) and~     long-acting β2 agonists (LABA)attains an improved control of symptoms and lung function, that~     are superior to those associated with either drug alone. However, the treatment efficacy~     between high and medium dose of inhaled corticosteroid in combination of LABA is still~     unknown. The aim of the current study is to investigate the treatment efficacy with high and~     medium dose of fluticasone in combination with salmeterol in COPD patients.~   "
185866|NCT01131793|"~     A single center Pilot Clinical Registry Study of the Acute Procedural Safety and Efficacy~     of Stereotaxis PowerAssert(TM)RF Coronary Total Occlusion System assisted Angioplasty in the~     Treatment of Refractory Coronary Total Occlusions~   "
185867|NCT01131780|"~     The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg +~     Pseudoephedrine HCL 30 mg under fasting conditions.~   "
185868|NCT01131767|"~     The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg +~     Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in~     healthy adult human subjects, under fed conditions.~   "
185869|NCT01131754|"~     Flushes with saline solution are used for maintaining patency of peripheral intermittent~     intravenous catheters in many institution based on the results of previous studies showing~     that 10 U heparin/mL is not better than saline in this respect. The latest meta-analysis~     investigated also safety and efficacy of heparin concentrations of 100 U/ml used as an~     intermittent flush, but no firm conclusion was reached because of limitations of the few~     available studies.~   "
185870|NCT01131741|"~     The purpose of this study is to determine whether changes in perfusion index can be used for~     detecting intravascular injection of an epinephrine in anesthetized adults and to compare its~     reliability with criteria using changes in heart rate, systolic blood pressure or T-wave~     amplitude.~   "
185871|NCT01131728|"~     The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg +~     Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in~     healthy adult human subjects, under fasting conditions.~   "
186006|NCT01129921|"~     This is a single-center, randomized, prospective, double-blind, clinical study to assess the~     clinical application and outcomes with mild® devices versus sham in patients with symptomatic~     moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to~     cross-over and have the actual decompression procedure after week 6 exam.~   "
185872|NCT01131715|"~     A pharmacist follow-up procedure is under development. Patients with coronary heart disease~     (CHD) is being followed up by a pharmacist for one year with three meetings; at discharge~     from hospital, after three months and after one year. The evaluation is basically based on~     quantitative measures as achievement of therapeutic goals, number of drug related problems~     detected, hospitalisations etc. However, the patients' own experience with the follow-up~     procedure cannot be evaluated using these measures. Thus, a qualitative approach is needed.~     In this study, a total of four patients participating in the follow-up will be included and~     interviewed. A semistructured interview guide will be used. Interviews will be taped,~     transcribed and analyzed with the intention to explore how patients experience the follow-up~     from the pharmacist. A thoruough content analysis will be performed. Patients included must~     have met the pharmacist at least twice. The pharmacist in charge of the follow-up will~     recruit patients and hand out study information. Patients will reply to the principal~     investigator of the study and thus kept anonymous for the pharmacist in charge of the~     follow-up. No pressure will be put on the patients to join, but it will be emphasized that it~     will help evaluating the procedure.~   "
185873|NCT01131702|"~     The purpose of this study is to compare the rate and extent of absorption of ranitidine 300~     mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting~     conditions.~   "
185874|NCT01131689|"~     In preclinical studies, 5-fluorouracil, one of the active metabolites of S-1, showed~     synergistic effect to sorafenib in human colon carcinoma cell lines. Therefore, sorafenib~     combined with S-1 might be more effective treatment for patients with advanced HCC than~     sorafenib monotherapy. The investigators propose to conduct a phase I study to determine~     maximal tolerated dose (MTD) of S-1 in combination with fixed dose of sorafenib in patients~     with advanced HCC~   "
185875|NCT01131676|"~     The aim of the present study is to investigate the safety of BI 10773 treatment in patients~     with Type 2 Diabetes Mellitus and high cardiovascular risk.~   "
185876|NCT01131663|"~     Face masks are used for many respiratory care applications such as anaesthesia,~     resuscitation, and aerosol therapy. None of the currently available face mask for infants and~     young children are specifically designed and developed for infants. The aim of this study is~     to design, develop and test the first infant's oriented face mask.~      To achieve this ultimate goal we will first define appropriate sizes of infants' faces that~     would be used as templates for the design and development of optimally fitted model masks. In~     the next stage we will use these masks and incorporate the infants' own soother (pacifier)~     into a new SootherMask (SM). In the last part of the study we will compare acceptance levels~     between Soothermask (SM) and a conventional commodity masks without a pacifier.~   "
185877|NCT01131650|"~     Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil~      Abstract~      Objective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among~     patients from São José do Rio Preto-SP-Brazil .~      Local: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)~      Methods: Design: population-based cross-sectional study. The study sample, of 710 patients~     was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program)~     of São José do Rio Preto . All patients , known to have diabetes , underwent an eye~     examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through~     dilated pupils. Participants were also interviewed and examined to determine their~     demographic characteristics, medical conditions and the realization of previous fundoscopic~     eye examination. Statistical studies were done with t -Student test , Fisher test or~     chi-square test.~   "
185878|NCT01131637|"~     The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of~     heart failure.~   "
185879|NCT01131624|"~     The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron~     therapy (iron that is infused directly into your body through a vein), compares with ferrous~     sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during~     pregnancy.~   "
185880|NCT01131611|"~     The overall objective of this application is to conduct a two-group randomized controlled~     trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral~     based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine~     surgery for degenerative conditions. Our central hypothesis is that incorporating cognitive~     and behavioral strategies into postoperative standard of care PT will improve surgical~     outcomes, through reductions in fear of movement and pain catastrophizing. We have~     established the feasibility of training therapists in the CBPT intervention, recruiting and~     retaining patients, and the procedures for data collection and study management. The~     long-term goal is to broaden the availability of well-accepted and effective CBT strategies~     by expanding the implementation from traditional providers, psychologists, to a group of~     providers, physical therapists, who routinely interact with musculoskeletal pain populations.~   "
185881|NCT01131598|"~     The investigators propose to perform a one-year prospective audit of all Acute lung injury~     (ALI)and cute respiratory distress syndrome (ARDS) pediatric patients managed in several ICUs~     in Spain. The investigators intend to collect data from all children (from 1 month to 18~     years of age) admitted with or developing ALI/ARDS with the aim to understand the~     epidemiology and natural history of acute lung injury in the pediatric setting. These ICUs~     are scattered through the Spain and are representative of the demographic differences across~     the country.~   "
185882|NCT01131585|"~     This study was designed to confirm the efficacy and safety of laser photocoagulation as~     adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual~     impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic~     Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as~     adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.~   "
185883|NCT01131572|"~     This study tests NAC in the treatment of Bulimia Nervosa.~   "
185884|NCT01131559|"~     The specific aim of this study is to evaluate the efficacy and tolerability of~     lisdexamfetamine in the adjunctive treatment of bipolar disorder.~   "
185885|NCT01131546|"~     This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or~     5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential~     hypertension.~   "
185886|NCT01131533|"~     The investigators investigate intraocular concentrations and pharmacokinetics of~     erythropoietin after a single intravitreal injection in humans.~   "
185889|NCT01131494|"~     Dysphagia in Parkinson's disease(PD) is common and its presence is related to motor and~     sensory abnormalities, and incoordination between swallowing and breathing. Despite harming~     as respiratory infections and increased risk of death, treatment of this condition remains~     uncertain. This study aims to evaluate the effect of oral motor exercises on the swallowing~     dynamics and quality of life of dysphagic Parkinson's disease patients. This study is an open~     trial, self-paired and blinded to the examiner. The participants will perform oropharyngeal~     exercises for five weeks and will be evaluated before and after intervention by swallowing~     videofluoroscopy and questionnaires about quality of life in dysphagia (SWAL-QOL).~   "
185890|NCT01131481|"~     Evaluation of glistenings in intraocular lenses implanted in normal patients following~     routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs~     AcrySof MA50BM made by the Alcon company.~   "
185891|NCT01131468|"~     The purpose of this study is to determine whether N-acetylcysteine is effective in the~     prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced~     ototoxicity in peritoneal dialysis patients.~   "
185892|NCT01131455|"~     To compare the outcomes of patients who undergo three different types of surgeries for ankle~     fusion and reconstruction.~   "
185893|NCT01131442|"~     Currently, the pathophysiology of Irritable bowel syndrome( IBS) remains unclear . The~     purpose of this study is want to investigate the immunological changes in the children with~     IBS.~   "
185894|NCT01131429|"~     Objective: the objective of this study in china is to clarify, whether the overall survival~     is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR~     mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those~     receiving first-line docetaxel/cisplatin plus second-line erlotinib .~   "
185895|NCT01131416|"~     Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have~     traditionally withheld postoperative oral intake until the return of bowel function to~     prevent related complications. Gum chewing can stimulates bowel movement and promotes the~     return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes~     secretion.~      The objectives of this study are to examine effects of adding gum chewing to the conventional~     postoperative feeding regimen on the return of bowel function, its related complications, and~     patients' satisfaction.~   "
185896|NCT01131403|"~     Study design:~      The purpose of the present study is to analyse of the influence of the application of the~     skin care products on the diaper area (Factor A) and the application of a cotton wool cloth,~     moistened with clear water on the diaper area (Faktor B) on the skin barrier function of the~     newborns during the first four weeks. Additionally, the microbiological colonisation of the~     skin will be observed. After four weeks all infants in both groups will obtain wet wipe and~     after 8 weeks a facultative measurement will be performed.~      Primary and secondary end points:~      In the present study, as a primary end point TEWL on the buttock was chosen, because the~     significant difference between the infants who were bathed and washed in the previous study~     was found.~      Secondary end points are the TEWL on the other measuring points, pH-value and SCH.~     Additionally, secondary end points are the D-Squame method and the cytokine measurement with~     Sebutapes.~      Hypotheses:~      The intention of the study is to evaluate, whether the using of wet wipe on the diaper area~     has an influence on the TEWL of the newborns. The following hypotheses are present below:~      H0 (Null hypothesis): The TEWL is indistinguishable between infants who get cleaned with wet~     wipe on the diaper area and infants who get cleaned with a cotton wool cloth, moistened with~     clear water on the diaper area, i.e.~      TEWL clear water is equal TEWL wet wipe against H1 (Alternative hypothesis - bilateral): The~     TEWL is distinguishable between infants who get cleaned with wet wipe on the diaper area and~     infants who get cleaned with a cotton wool cloth, moistened with clear water on the diaper~     area, i.e.~      TEWL clear water is not equal TEWL wet wipe~   "
185897|NCT01131390|"~     No studies have been done to examine whether patients with obstructive lung disease and~     obesity are more comfortable on some ventilator settings than on others. The purpose of the~     current study is to examine this question systematically.~   "
185898|NCT01131377|"~     Metabolic alkalosis(MA) is common metabolic disorder in ICU setting. MA could be cause of~     weaning failure or delay by depression of respiratory center. The purpose of this study is to~     evaluate that correction of MA by administration of acetazolamide facilitates weaning of~     mechanical ventilation.~   "
185899|NCT01131364|"~     This Phase Ib/II study is an openlabel, multicenter study for patients with solid tumors and~     breast cancer amenable to anthracyclin therapy.~      The study is divided in two parts:~      Phase I: an open-label, dose escalation study of F16IL2 in combination with doxorubicin for~     patients with solid tumors.~      Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in~     combination with doxorubicin, equivalent to stage 1 of the Simon two-stage phase II design,~     for patients with breast cancer amenable to anthracyclin therapy.~   "
185900|NCT01131351|"~     The purpose of this study is:~        -  To evaluate the safety and tolerability of orally administered OPC-67683 when~          administered two times daily (BID) to MDR TB patients refractory to treatment with an~          optimized background regimen of anti-TB medications (OBR).~        -  To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.~   "
185901|NCT01131325|"~     This study is to determine the number of European Leukemia Network (ELN)guideline defined~     treatment failure events from time of study entry in CML-CP patients with low imatinib trough~     concentrations treated with nilotinib.~   "
185910|NCT01131195|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     paclitaxel, cyclophosphamide, and capecitabine, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet~     known whether bevacizumab is more effective when given together with paclitaxel or~     cyclophosphamide and capecitabine in treating patients with breast cancer.~      PURPOSE: This randomized phase III trial is studying the side effects of giving bevacizumab~     together with paclitaxel and to see how well it works compared with giving bevacizumab~     together with cyclophosphamide and capecitabine as first-line therapy in treating women with~     locally advanced, recurrent, or metastatic breast cancer.~   "
185902|NCT01131312|"~     Approximately 65 million Pap smears are performed each year in the United States. The vast~     majority of results are negative (no abnormality identified) but about 5 percent to 8 percent~     are reported as abnormal. Most low-grade changes regress spontaneously; only a minority of~     such lesions would progress to a cancer precursor without treatment. However, there is no way~     to determine morphologically which patients are at risk or progression. Therefore, both high-~     and low-grade lesions were often managed with colposcopy and directed biopsy. It was~     anticipated that determining alternative management strategies would yield important~     potential benefits including fewer medical complications from over treatment, reduced patient~     anxiety associated with referral for cytologic abnormalities, as well as cost savings.~      Epidemiologic, virologic and molecular studies have clearly demonstrated that human~     papillomavirus (HPV) is the central cause of cervical cancer. The motivation for the ALTS~     trial was to use the information we have gained about the role of HPV to design better~     treatment and prevention strategies to reduce the burden of cervical cancer and its~     precursors.~      ALTS consisted of three management strategies: (1) immediate colposcopy of all women; (2)~     repeat cytology with colposcopy only if the results show a high grade lesion; and (3) HPV~     testing and repeat cytology in combination, with referral to colposcopy if either the HPV~     test is positive or the cytology shows a high grade lesion. Four Clinical Centers University~     of Alabama, Birmingham AL; Magee-Womens Hospital, Pittsburgh PA; University of Oklahoma,~     Oklahoma City OK; and University of Washington, Seattle WA enrolled approximately 5,000 women~     with recent diagnosis of ASCUS or LSIL. Participants were followed at six month intervals for~     a total of 2 years. The main results from ALTS showed that for women with ASCUS cytology, HPV~     triage was at least as safe as universal immediate colposcopy in the detection of high-grade~     lesion and would allow approximately half of women to return to routine follow up without~     additional procedures (colposcopy). No efficient triage strategy was identified for women~     with LSIL cytology.~      The ALTS database and ALTS specimens continue to be a valuable research resource in studies~     of cervical cancer precursors, screening tests, visual assessment of the cervix and~     investigation of biomarkers.~   "
185903|NCT01131299|"~     Background:~        -  Cardiovascular disease (CVD) is a leading cause of death in developed countries.~          Although statin-type drugs are currently the most effective therapeutic agents for~          reducing CVD risk. One possible complementary approach involves the use of soluble~          dietary fibers that are known to reduce blood cholesterol levels. However, analysis has~          shown that most soluble fibers reduce total cholesterol levels by relatively small~          amounts.~        -  Alpha-Cyclodextrin (Alpha-CD), also sold in commerical form, is a soluble fiber derived~          from corn that is used as an ingredient in many foods, such as bread rolls, crackers,~          juices, and reduced fat spreads. It is added to food primarily as a fiber supplement but~          is also used to stabilize flavors, colors, vitamins, and fatty acids. Studies in animals~          and humans have shown that Alpha-CD may help to improve insulin resistance and lower LDL~          cholesterol levels with no apparent side effects. More research is needed to determine~          the effect of Alpha-CD on total cholesterol levels in healthy volunteers.~      Objectives:~      - To determine the effect of oral Alpha-CD on total cholesterol in a nondiabetic population.~   "
185904|NCT01131273|"~     This study will obtain pilot data on the acceptability of a 12-week course of daily observed~     suboxone and methadone, followed by a dose taper or referral to a local treatment program for~     80 opioid dependent patients (40 group) who have been injecting subutex or other~     buprenorphine preparations 10 or more days in the past 30, and on the impact of each~     medication on HIV risk and on subutex and opioid use during treatment and a followup at week~     20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research~     Center, Union Alternative of Georgia in Tbilisi.~   "
185905|NCT01131260|"~     The purpose of this research is to test a new instrument, called a fetal STAN monitor, that~     may be used during labor to monitor the electrical activity of the baby's heart. This new~     instrument is designed to help the doctor determine how well the baby is doing during labor.~     It will be used along with the existing electronic fetal monitor used to measure the baby's~     heart rate and the mother's contractions during birth. The specific purpose of this research~     study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn~     health.~   "
185906|NCT01131247|"~     Investigational Drugs:~      Ofatumumab (Azerra) + bendamustine (Trenda)~      Route of Administration:~      Intravenous (IV)~      Hypothesis:~      This study is designed to assess the toxicity and overall response rate. Ofatumumab is a~     fully human monoclonal antibody (A type of protein made in the laboratory that can bind to~     substances in the body, including tumor cells) that shows promising activity in the treatment~     of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA~     approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given~     alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL.~      Participation:~      Approximately 37 relapsed/refractory CLL subjects will participate in this study over two~     years.~      Treatment Plan:~      A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV~     300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by~     bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be~     administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only~     patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will~     be given on day 1 only.~      Follow-up:~      Patients will be followed monthly for six months, then every three months for five years then~     annually thereafter.~   "
185907|NCT01131234|"~     This phase I clinical trial is studying the side effects and best dose of giving~     gamma-secretase inhibitor RO4929097 and cediranib maleate together in treating patients with~     advanced solid tumors. Gamma-secretase inhibitor RO4929097 and cediranib maleate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib~     maleate also may stop the growth of tumor cells by blocking blood flow to the tumor.~   "
185908|NCT01131221|"~     RATIONALE: Studying samples of serum from patients with cancer in the laboratory may help~     doctors identify and learn more biomarkers related to cancer. It may also help doctors~     predict how well patients will respond to treatment.~      PURPOSE: This research study is studying vitamin D insufficiency in determining prognosis in~     patients with newly diagnosed follicular lymphoma.~   "
185909|NCT01131208|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how well patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell~     lymphoma treated with combination chemotherapy with or without rituximab.~   "
185911|NCT01131182|"~     This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan~     is lower when treated with sitagliptin as compared to sulfonylurea treatment.~   "
186629|NCT01121744|"~     The primary objective of this study is to evaluate the pharmacokinetic (PK) and safety~     associated with Supralimus-Core™ Sirolimus Eluting Coronary Stent system in the treatment of~     single de novo lesions in native coronary arteries between 2.5 to 3.5 mm in diameter.~   "
185912|NCT01131169|"~     The patients are being offered a stem cell transplant. Stem cells are very early blood cells.~     They have not yet matured to become red or white blood cells or platelets. They have already~     received the standard treatment of chemotherapy and an autologous stem cell transplant. An~     autologous stem cell transplant is when the patient receives their infusion of their own~     cells. Thi will give the patient a better chance of curing the disease, this protocol~     includes an infusion of stem cells from the blood (or the bone marrow) of another person.~     This is called an allogeneic stem cell transplant. The stem cells will begin to grow in the~     bone marrow and produce new blood cells.~      Allogeneic stem cell transplants can cause a condition called graft-versus-host disease or~     GVHD. In GVHD, a kind of white blood cell from the donor (graft) begins to attack the body~     (host). That blood cell is called a T-cell. It is a cell that normally helps to protects~     against things like bacteria and viruses. In this case, the donor's T-cells see the body as~     foreign in the same way they would see bacteria as foreign. GVHD can be fatal. In order to~     lower the chance that the patient will get GVHD this protocol treatment will remove the~     T-cells from the donor's cells. This is called T-cell depletion. The T cells are removed by a~     system called Clinimacs. This method is still being evaluated through clinical trials and~     not been approved by the Federal Drug Administration (FDA) at this time.~      Before the transplant, the physician will treat the bone marrow to get rid of the cancer. The~     physician uses three chemotherapy drugs plus ATG. The chemotherapy drugs (Busulfan, Melphalan~     and Fludarabine) kills the cancer. ATG gets rid of any of the patients T cells that survive~     the chemotherapy. This ensures that the donor stem cells are not rejected. The patient will~     also receive additional white blood cells called lymphocytes from the donor. This is called a~     donor lymphocyte infusion or DLI. These additional infusions will help cause a~     graft-versus-myeloma effect and can help the donor stem cells grow.~   "
185913|NCT01131156|"~     The investigators hypothesized that an enriched focus on mother-infant bonding during a~     newborn's hospitalization in the Neonatal Intensive Care Unit would reduced the rate maternal~     postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had~     quit smoking during or just prior to pregnancy.~   "
185914|NCT01131143|"~     This study will test the effect of provider to patient interactive voice response (IVR) calls~     in local Community Health Centers within a weight management program.~   "
185915|NCT01131130|"~     The objective of this study is to determine the product feasibility of the investigational~     contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens~     (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft~     contact lenses.~   "
185916|NCT01131117|"~     The overall goal of this project is to understand how a mother's health at conception may~     influence her child's growth and development.~   "
185917|NCT01131104|"~     Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective,~     case-crossover study to evaluate the possible association between the use of~     phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior~     ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked~     via a structured questionnaire about their use of PDE5 inhibitors and other risk factors~     prior to the onset of their vision loss.~   "
185918|NCT01131091|"~     This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are~     planned (5 groups of 6 subjects each.)~   "
185919|NCT01131078|"~     A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic~     cancer of the colon or rectum. The anticipated time on study treatment is until disease~     progression.~   "
185920|NCT01131065|"~     The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of~     Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV)~     reinfection in patients submitted to liver transplantation due to HBV-induced liver disease~     by reaching and maintaining certain hepatitis B antibody (HBsAg) levels considered as~     protective during the first six and twelve months post-transplantation.~   "
185921|NCT01131052|"~     Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75~     years and 40% of adults >80years of age. It is expected that the number of elderly people~     suffering from diabetes will increase in the future, as general life expectancy is~     increasing.~      Nursing home residents with diabetes have higher rates of serious comorbidities and have~     greater activity of daily living dependencies than other residents without diabetes. In~     addition, persons with diabetes have higher risk of hypertension, heart disease, stroke~     depression, cognitive impairment, and cardiovascular mortality than individuals without~     diabetes.~      There are a few retrospective studies in elderly patients analyzing quality of diabetes care~     and glycemic control adjusted for medications and presence of co-morbidities in long-term~     care facilities; however, no previous randomized controlled trials have demonstrated benefits~     of glycemic control on clinical outcome, quality of life, and rate of acute metabolic~     complications (hyperglycemia and hypoglycemic events) in long-term care facilities. In~     addition, it is not known whether the use of basal insulin is superior to treatment with~     sliding scale insulin (SSI) in long-term care facility residents with type 2 diabetes.~      Accordingly, the investigators propose to conduct a prospective randomized control trial~     comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale~     regular insulin in the management of nursing home patients with T2DM.~   "
185922|NCT01131039|"~     The purpose of the study is to determine whether the administration of bevacizumab and~     gemcitabine given by IV infusion can prolong survival, delay tumor growth, and/or shrink~     tumors in patients with ovarian cancer, primary peritoneal, or fallopian tube cancer.~   "
185923|NCT01131026|"~     Today, although the triple treatment with clarithromycin accepted as the primary treatment~     for Helicobacter pylori infection eradication is well tolerated, the eradication has been~     decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin~     is expected to be 75 % or higher. If the target results can be reached, it will be concluded~     that TRIOL treatment with levofloxacin will be an alternative to the triple treatment with~     clarithromycin as the primary treatment.~   "
185924|NCT01131013|"~     The primary objective of this early-stage clinical study is to demonstrate an effect of~     single doses of CK-2017357 on measures of skeletal muscle function and fatigability in~     patients with peripheral artery disease and symptomatic claudication.~   "
185925|NCT01131000|"~     The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on~     reducing fever at 4 hours.~   "
185926|NCT01130987|"~     The investigators propose to test the hypothesis that implementation of a comprehensive~     handoff program (CHP) - i.e., implementation of a computerized handoff tool along with~     teamwork training for internal medicine residents on inpatient units at Walter Reed and~     Madigan Army Medical Centers - will lead to reductions in resident miscommunications /~     medical errors and improvements in workflow and experience on the wards.~   "
185927|NCT01130974|"~     The objective of this study is to evaluate the safety and efficacy of the Bausch & Lomb daily~     disposable tint contact lens (Test) compared to a currently marketed daily disposable~     cosmetic tint contact lens (Control).~   "
185931|NCT01130922|"~     Roux-and-Y gastric bypass is one of the most common forms of bariatric surgery; due to a~     reduction in size of the stomach and intestine, the available surface area for the absorption~     of oral drugs is strongly decreased. This may lead to a reduced bioavailability resulting in~     a reduced efficacy of the drug. However, in literature there is no information available~     about the impact of bariatric surgery on the pharmacokinetics of moxifloxacin. This protocol~     evaluates the moxifloxacin plasma levels, the variability between subjects and the absolute~     bioavailability, after oral administration of 400 mg moxifloxacin in healthy volunteers who~     have had a gastric bypass at least 6 months ago and who now have a stable body weight.~   "
185932|NCT01130909|"~     This study will provide data to support preclinical to clinical translation by aligning~     preclinical and clinical efficacy assay with dose dependent changes in EEG.~   "
185933|NCT01130896|"~     Patients with implanted cardiac devices who meet appropriate entrance criteria undergo~     clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety~     protocol.~   "
185934|NCT01130883|"~     This post-marketing observational study (PMOS) will be conducted in a prospective,~     single-arm, single-country, multicenter format. The investigational sites will be consulting~     rooms of GPs (general practitioner), pneumologists and centers with experience in the~     treatment of patients with acute infections of trachea, bronchi, AECB (acute exacerbation of~     chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a~     post-marketing observational study, Klacid SR will be prescribed in usual manner in~     accordance with the terms of the local market authorization with regards to dose, population~     and indication as well as local guidelines. Objective: to describe the effectiveness of the~     treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute~     tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic~     bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment~     6 weeks to 24 months prior to the Klacid SR dose administered within this study.~   "
185935|NCT01130870|"~     The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain~     same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal~     incontinence as stimulation with amplitude at sensory threshold.~   "
185936|NCT01130857|"~     Despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis,~     this potentially crippling disease still requires pathological diagnosis in practically every~     case. It seems likely that a correctly estimated clinical probability could help in~     evaluating imaging results in a way that might safely obviate temporal biopsy in a large~     segment of suspect cases.~      With this aim in view, we intend to identify useful clinical items and integrate them in an~     appropriate diagnostic pathway.~   "
185937|NCT01130844|"~     The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine~     following administration in children and adolescents with ulcerative colitis.~   "
185938|NCT01130831|"~     To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease~     Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in~     patients previously treated with calcium-based phosphate binder therapy.~   "
185939|NCT01130818|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)~     oral dose of GLPG0492 compared to placebo in healthy subjects.~      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral~     administration will be evaluated, and, if applicable, the maximum tolerated dose determined.~     Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy~     elderly subjects.~   "
185940|NCT01130805|"~     In order to improve survival of metastatic gastric cancer patients, we plan to to conduct a~     phase II trial of CapeOx with 800 mg once-daily pazopanib as a first-line chemotherapy in~     metastatic gastric cancer patients.~   "
185941|NCT01130792|"~     The overall goal of this study is to investigate whether the modulatory effects of~     probiotics, which are used as food supplements (Lactobacillus GG marketed as Culturelle or~     yoghurt) in the gastrointestinal tract promote restoration of intestinal function and enhance~     the specific immune response in children with cryptosporidial or rotaviral infections in~     South India. Rotavirus and Cryptosporidium spp. are the most important viral and parasitic~     causes of gastroenteritis in children in south India. Both infections can lead to severe~     dehydrating gastroenteritis in young children and have no specific treatment. Repeated~     episodes of diarrhea can result in long term deleterious effects on nutritional status,~     possibly due to intestinal damage. Most episodes of infectious gastroenteritis resolve~     without specific therapy, the mainstay of treatment being rehydration. However, oral~     rehydration remains under-utilized, in part due to the lack of effect on frequency of bowel~     movements and duration of illness. Due to the interest in simple, safe and effective measures~     to ameliorate the long-term effects of diarrheal illness, there is a growing appreciation for~     the potential of certain microorganisms to offer direct benefits to the health of a host.~     Probiotics are known to beneficially modulate several host functions, the most important of~     which are immune responses and intestinal barrier integrity. The investigators propose to~     build on the investigators previous collaborative efforts to conduct pilot studies to provide~     a mechanistic understanding of the effect of probiotic supplementation in children with~     rotaviral and cryptosporidial diarrhea.~      Based on the established efficacy of LGG for the treatment of a variety of diarrheal diseases~     and the documented modulation of immune responses and strengthening of intestinal epithelial~     barrier function by probiotics, the investigators propose to conduct a Phase I/II~     double-blind randomized placebo controlled clinical trial to assess the preliminary efficacy~     and safety of LGG vs. placebo in the resolution of symptoms and restoration of intestinal~     function in children with either rotaviral or cryptosporidial diarrhea and no other detected~     enteric infection. Promising results in this Phase I/II study will provide preliminary data~     to power a future randomized trial on these critical outcomes following rotaviral or~     cryptosporidial infection.~   "
185942|NCT01130779|"~     Newly developed or progressive brain metastasis during erlotinib treatment is considered~     progressive disease requiring change of treatment regimens despite no progression in~     extracranial lesions. Given that there is a dissociation in terms of response to erlotinib~     between brain and extracranial sites, we intend to conduct this pilot study to determine~     whether the continuation of erlotinib treatment can prolong the progression free interval of~     extracranial lesions as long as cranial lesion is controlled separately by conventional~     treatment modalities such as surgical resection, stereotactic radiosurgery, and whole brain~     radiotherapy.~   "
185943|NCT01130766|"~     The prognosis of NSCLC patients with asymptomatic brain metastasis, who are not treated with~     SRS or WBRT has not been fully investigated yet. This randomized phase III trial is conducted~     to determine the exact role of SRS in NSCLC patients with asymptomatic oligo brain metastases~     whether early treatment with SRS would improve survival even in patients with asymptomatic~     brain metastasis.~   "
185944|NCT01130753|"~     This study propose neoadjuvant chemotherapeutic role by erlotinib.~   "
187921|NCT01104805|"~     The main objective of this study is to evaluate the effectiveness of including an~     interactive, web-based version of the Community Reinforcement Approach (CRA), called the~     Therapeutic Education System (TES), as part of community-based, outpatient substance abuse~     treatment.~   "
185945|NCT01130740|"~     Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of~     disability among veterans. Many veterans with OA have significant pain and functional~     limitations, even though they receive some medical care for their OA. Efforts are needed to~     help veterans to improve OA-related outcomes. This study will examine a comprehensive~     approach to helping veterans manage their OA-related symptoms, in the context of a VA~     clinical setting. The study examines an intervention aimed at helping veterans with behaviors~     that are known to improve OA-related pain and function (such as exercise, weight management,~     and coping with pain), as well as helping providers to implement evidence-based~     recommendations for clinical care. The intervention is relatively low cost and easy to~     disseminate, with the patient component being telephone based. Therefore, if effective, this~     intervention could be implemented widely across the VA healthcare system.~   "
185946|NCT01130727|"~     The purpose of this study is to determine whether green tea or cocoa extracts are effective~     in improve endothelial dysfunction in patients with diabetes mellitus and nephropathy and~     arterial hypertension.~   "
185947|NCT01130714|"~     The purpose of this study is to examine the effectiveness of a resistance training program on~     reducing systemic inflammation and improving chemotherapy completion in lung cancer patients~     being treated with curative intent chemotherapy.~   "
185948|NCT01130701|"~     In this study, a new chemotherapeutic agent, panitumumab, will be tested in combination with~     another chemotherapeutic drug, capecitabine, along with external radiotherapy, to find out~     whether this combination is effective and safe to use before surgery.~   "
185949|NCT01130688|"~     The leukemic stem cells (LSCs) are cells that self- renew and give rise to leukemia.~     Eradication of LSC is required for cure. In chronic myelogenous leukemia (CML) LSCs are not~     eradicated by imatinib (Gleevec) alone. Recent discovery by Dr. Shaoguang Li at University of~     Massachusetts indicates that the LSCs can be targeted by a new drug zileuton (Chen et al.~     Nature Genetics 2009; 41:783-792). Zileuton (approved for asthma) will be tested in a~     combination with Gleevec. This combination has not been used previously to treat leukemia.~      This is a Phase I study. The goal of this research is to evaluate the safety of the standard~     anti-cancer drug imatinib and experimental drug zileuton.~   "
185950|NCT01130675|"~     The purpose of this study is to determine if consuming an 8 ounce cup of coffee with~     breakfast and lunch is effective in preventing or reducing postoperative ileus.~   "
185951|NCT01130662|"~     The purpose of this study is to determine the tolerated dose of the combination of decitabine~     and midostaurin as induction (first cycle of chemotherapy) and consolidation (additional~     chemotherapy once a patient goes into remission) in people greater than 60 years with newly~     diagnosed AML or adult patients with relapsed/refractory disease.~   "
185952|NCT01130649|"~     The investigators propose a novel method for tracking the seizure frequency, side effect~     burden, and medication compliance for patients with epilepsy. The investigators intend to~     utilize a table-top device currently for tracking other chronic disease to collect remote~     data from epilepsy patients. The hypothesis is that the use of this device will lead to~     better longterm treatment outcomes than the standard outpatient mechanism of following~     patients longitudinally.~   "
185953|NCT01130636|"~     The main purpose of this study is to assess the potential exposure of neonates to oseltamivir~     during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast~     milk in breastfeeding women who are treated with oseltamivir, an anti-flu medication.~   "
185954|NCT01130623|"~     Background:~      - Pazopanib, a drug that inhibits the growth of new blood vessels in tumors, was recently~     approved by the Food and Drug Administration to treat advanced kidney cancer in adults.~     Pazopanib has been used in only a small number of adults, and more research is needed on~     whether it is safe and effective to use in children. Researchers are interested in~     determining safe and effective treatment doses of pazopanib in children, and in other studies~     will examine which form of pazopanib treatment (tablet or liquid) is most effective and well~     tolerated.~      Objectives:~        -  To determine a safe and effective dose of pazopanib to treat solid tumors in children.~        -  To study the effects of pazopanib on blood cells, blood flow, and human development.~      Eligibility:~      - Children, adolescents, and young adults between 1 and 21 years of age who have been~     diagnosed with solid tumors that have not responded to treatment.~      Design:~        -  Eligible participants will be screened with a physical examination, blood and tumor~          samples, and imaging studies.~        -  Participants will receive pazopanib tablets for 28-day cycles of treatment. Pazopanib~          should be taken on an empty stomach, at least 1hour before or 2 hours after a meal.~          Participants may receive pazopanib for up to 24 cycles unless the tumor does not respond~          or participants develop serious side effects.~        -  Blood samples will be taken on days 1, 15, 22, and 27 of the first cycle of pazopanib,~          with additional samples taken every 8 weeks during subsequent cycles.~        -  An optional part of the study will collect additional blood samples at regular intervals~          for 24 hours after the first dose of pazopanib and at regular intervals after another~          dose during the second or third week of the first treatment cycle.~   "
185955|NCT01130610|"~     Study conducted in large Brazilian hospital, with the main objective of evaluating the impact~     of pre-anesthetic in reducing costs related to the preoperative preparation of patients~     admitted to undergo surgery or diagnostic procedures under anesthesia.~   "
185956|NCT01130597|"~     The purpose of this study was to evaluate the feasibility of individualized titration of~     patiromer according to serum potassium. This study also assessed the safety and tolerability~     of patiromer and the effects of patiromer on serum potassium in heart failure (HF)~     participants with chronic kidney disease (CKD).~   "
185957|NCT01130584|"~     The purpose of this study is to determine if pyruvate kinase M2 (PKM2) can be used as a~     biomarker in cancer.~      Pyruvate kinase M2 is more elevated in malignant pleural fluid than in plasma, and may be a~     useful biomarker to distinguish between malignant and non-malignant causes of pleural~     effusion. In addition, pyruvate kinase M2 has also been found to be elevated in saliva in~     cancer patients compared to controls. Measuring pyruvate kinase M2 in saliva may be used to~     diagnose cancer or monitor the treatment progress of cancer.~   "
186018|NCT01129765|"~     This study evaluates labeling comprehension, ease of use and effectiveness of a new device~     for nasal and sinus irrigation and/or aspiration. The device is currently cleared for~     professional use and home use with a prescription. This is a usability study to demonstrate~     that this device is appropriate for home use.~   "
185958|NCT01130571|"~     Xenografts and cell cultures provide sufficient material for analyses at the protein, RNA and~     DNA level. Patient derived NSCLC xenografts and cell lines are available but none however are~     Asian in origin. Given the emerging evidence to suggest inter-ethnic differences in NSCLC~     biology, new models of preclinical drug evaluation should be designed and validated using~     Asian tumors. Furthermore, such models will allow studies of biological mechanisms of~     sensitivity and/or resistance and also the study of dynamic regulations under standardized~     conditions in the Asian context.~   "
185959|NCT01130558|"~     The purpose of this study is to determine whether an electronic order template for~     basal-bolus insulin will improve mean blood glucose in hospitalized general medical patients~     with poorly controlled type 2 diabetes.~   "
185960|NCT01130545|"~     Background:~      - Magnetic resonance imaging (MRI) scans must be performed according to specified sets of~     parameters that provide optimal images of each organ and each area of the body. These~     scanning parameters are often specific to the institution or organization at which they are~     employed, and may also depend on the manufacturer of the MRI scanning equipment. Because MRI~     scanning equipment is always being updated and upgraded, researchers are interested in~     developing new and optimized scanning parameters for MRI scans.~      Objectives:~      - To improve current methods and develop new techniques for magnetic resonance imaging.~      Eligibility:~        -  Individuals 18 years of age and older who are either volunteers or current NIH protocol~          participants.~        -  Participants must not have any medical history factors (e.g., extreme claustrophobia,~          history of metal implants) that would prevent them from receiving MRI scans.~      Design:~        -  Participants will have at least one MRI scan that will last from 20 minutes to 2 hours~          (most scans will last between 45 and 90 minutes). The total time commitment for most~          visits will be approximately 4 hours from start to finish.~        -  Some MRI techniques require standard monitoring equipment or specific procedures during~          the scanning, such as an electrocardiogram.~        -  Participants will have blood samples taken at the time of the scan. Some MRI studies~          will require the use of a contrast agent that will be administered during the scan.~        -  Volunteers may be asked to return for additional MRI scans over the course of a few~          years. Follow-up scans may be done on the same part of the body or on different parts of~          the body. No more than one MRI scan will be performed in any 4-week period for this~          protocol.~   "
185961|NCT01130532|"~     The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow~     men to return to normal erectile function in those who did not have normal erectile function~     following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.~   "
185962|NCT01130519|"~     Background:~        -  At the present time, there are no drugs that have been proven to work in patients with~          papillary kidney cancer that has spread (metastasized) beyond the kidneys. Researchers~          are interested in determining whether the combination of the drugs bevacizumab and~          erlotinib can be used to treat metastatic papillary kidney cancer.~        -  Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC) is an inherited type of~          papillary kidney cancer (it runs in families). Papillary kidney cancer can also occur~          sporadically, or without a family connection. More research is needed to determine~          whether treatments for papillary kidney cancer, such as bevacizumab and erlotinib, work~          in inherited or sporadic types of kidney cancer, and if so, whether there are any~          differences.~      Objectives:~      -To determine the effectiveness of the combination of bevacizumab and erlotinib as a~     treatment for patients with (1) metastatic HLRCC kidney cancer and (2) metastatic kidney~     cancer not associated with HLRCC (or sporadic papillary RCC).~      Eligibility:~        -  Individuals 18 years of age or older who have been diagnosed with papillary kidney~          cancer that has spread beyond the kidneys.~        -  Participants may have either HLRCC or sporadic papillary kidney cancer.~      Design:~        -  Participants will be screened with a full medical history, physical examination, blood~          and urine tests, and CT and other scans to evaluate tumor size and treatment options.~        -  Participants will receive 28-day treatment cycles of bevacizumab (given intravenously~          every 2 weeks) and erlotinib (a tablet taken by mouth daily).~        -  Every cycle, participants will return for regular blood and urine tests. Every other~          cycle, participants will have imaging scans to assess tumor size and response to~          treatment. Female participants who have uterine fibroid tumors related to their kidney~          cancer may have additional scans to assess tumor size and response to treatment.~        -  Participants will continue to receive treatment on the study until their tumors grow or~          spread to new areas (disease progression), intolerable side effects develop, a better~          treatment option becomes available, the study closes, it is unsafe to continue~          treatment, or the participant decides not to remain in the study.~   "
185963|NCT01130506|"~     This phase I trial studies the side effects and the best dose of cytarabine when given~     together with decitabine and vorinostat in treating patients with acute myeloid leukemia or~     myelodysplastic syndrome that has returned or has not responded to treatment. Drugs used in~     chemotherapy, such as cytarabine and decitabine, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Vorinostat may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving cytarabine together with decitabine and vorinostat may~     kill more cancer cells.~   "
185964|NCT01130493|"~     This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced~     Parkinson's disease.~   "
185965|NCT01130480|"~     COMPASS is a status and intervention study for the self-monitoring of blood glucose (SMBG) in~     type 2 diabetic patients with insulin treatment. This multi-centre, open-label prospective~     study will assess the use and frequency of SMBG and blood glucose control and its influencing~     factors with the help of Accu-Chek Integra glucometer. Patients with type 2 diabetes mellitus~     who have received more than 3 months of insulin therapy are eligible to participate in this~     study. The anticipated duration of the study is 6 months.~   "
185966|NCT01130467|"~     The investigators try to objectively and scientifically explore various brain function~     impairments in ADHD children by electrophysiologic tests, with and without medication.~   "
185967|NCT01130454|"~     The objective of the study is to determine if one 45-minute treatment with the SCIO~     (Scientific Consciousness Interface Operations System) biofeedback device would show a~     change, and hopefully an improvement, on a person's Body Wellness indicators (Quality of Life~     Questionnaire, Energy Index Factor, Strength, Oxidation, Flexibility, Memory, pH, and VARHOPE~     scores (V=voltage, A=amperage, R=resistance, H=hydration, O=oxygenation, P=proton pressure~     and E=electron pressure), electrical measures within the device. For subjects in the control~     group, it is expected that there will likely be an improvement of approximately 5% in~     measured variables. That is, subjects in the control group will likely report some of the~     positive changes listed above for test group subjects. However, on average, any positive~     change in post-treatment measures for control subjects is expected to occur to a~     significantly lesser degree than for subjects in the test group.~   "
186019|NCT01129752|"~     The purpose of this study is to investigate risk factors associated with depression and how~     such factors might be transmitted cross-generationally. The investigators are conducting an~     integrative assessment of emotion regulation and stress reactivity in a group of mothers with~     and without a history of depression and their daughters.~   "
185968|NCT01130441|"~     Incarcerated adolescents engage in suicide ideation, self-harming behaviors and have poor~     coping abilities, suggesting a need for mental health intervention and treatment. Previous~     research on self-harm among community adolescents revealed that self-harmers were more likely~     than non-self-harmers to report suicidal ideation, and having made a suicide plan.~      This study plans to evaluate the suicidal intent of self-harming and non-self harming~     adolescent admitted at juvenile detention house in Taiwan. Furthermore, this study also plans~     to identify the prevalence and types of self-harming activities of incarcerated youths.~     Another purpose is to investigate the coping abilities of incarcerated youth, with evaluation~     of efficacy of short problem-solving skills therapy intervention by trained psychologists of~     three sessions for adolescents with poor coping adjustment; referral to adolescent~     psychiatrist when severe mental disorder or poor coping abilities were found.~      By analyzing their suicidal ideation, self-harming behaviors, and coping adjustment, the~     investigators will be able to give timely intervention and identify effective means and~     methods for better serving this population. This study hopes to help the incarcerated youth~     to replace their self-destructive behaviors with effective coping adjustment abilities.~   "
185969|NCT01130428|"~     Rationale: Mechanical loading is well-known to have a strong anabolic effect on bone. It has~     therefore been proposed that a mechanical intervention could be an effective~     non-pharmacological approach to treat bone loss associated with conditions such as osteopenia~     and osteoporosis. Data from in vitro experiments indicate that the purine nucleotide~     adenosine 5'-triphosphate (ATP) is released by bone cells and mediates cellular crosstalk via~     P2 purinergic receptors in response to mechanical stimulation. ATP release by bone cells may~     thus be part of a general mechanism by which mechanical loading ultimately results in~     increased bone formation, but this remains to be investigated in humans in vivo. The~     investigators hypothesize that a mechanical intervention in humans leads to a rise in~     systemic ATP concentrations due to ATP release from bone.~      Objective: To investigate in vivo whether a measurable increase in systemic ATP levels occurs~     in response to mechanical stimulation of bone in humans.~      Study design: Intervention study with a non-randomized, non-blinded design. All subjects will~     participate in a single experiment, lasting approximately 3 hours, during which the subjects~     will receive a mechanical intervention at a fixed dose.~      Study population: Maximally 10 healthy human volunteers (18-35 y). Intervention: Subjects~     will receive a gentle and safe mechanical intervention, which will be administered by means~     of a Juvent 1000 Vibration Platform delivering low-magnitude mechanical stimuli (i.e.~     vibrations) to the forearm. The mechanical stimulation will be administered at a frequency of~     90 Hz and amplitude of 10 µm in an intermittent fashion, i.e. three 10-minute periods of~     stimulation with 10-minute rest periods in between.~      Main outcome parameters: As the primary outcome parameter, a change in extracellular ATP~     concentrations as a result of the mechanical intervention will be assessed systemically.~   "
185970|NCT01130415|"~     The purpose of this study was to evaluate whether there is a difference in long-term outcome~     between patients screened with the percutaneous nerve evaluation (PNE) and first stage tined~     lead procedure (TLP).~   "
185971|NCT01130402|"~     The investigaotors want to establish a real-time and computerized score reporting system~     based on the significant predictors of the measured sonographic parameters and demographic~     data.~   "
185972|NCT01130389|"~     The purpose of this study was to examine risk factors for osteonecrosis of the jaw (ONJ),~     including the possible association with bisphosphonates (BPs). This study used the research~     infrastructure from the three NIDCR-funded dental practice-based research networks (DPBRN,~     PEARL, PRECEDENT). De-identified data from the DPBRN were merged with comparable~     de-identified data from PEARL and PRECEDENT to form a single trans-PBRN data set used for~     analysis.~   "
185973|NCT01130376|"~     For several years there has been interest in why some people with HIV-1 progress more slowly~     to disease and have longer survival without Highly Active Antiretroviral Therapy (HAART) than~     others. The investigators and others have identified a few HIV positive individuals who can~     control their viral load for many years without HAART, these rare individuals do not lose~     their HIV-1-specific cellular immune responses, which are very important for controlling~     viral load. This group is referred to as long-term non-progressors (LTNP). Unlike LTNP the~     majority of HIV-1 infected individuals are chronic progressors (CP) who do not make effective~     HIV-1-specific cellular immune responses, even when on HAART. We propose to use a novel DNA~     vaccine boosted with immune based therapy (cytokines and hormones) to try to regenerate the~     missing HIV-1-specific cellular immune responses to make chronically infected HIV-1+ persons~     more like LTNP.~      By injecting this novel DNA vaccine and immune based therapy into the people who are already~     infected with HIV-1, the immune system may be stimulated to mount a greater immune response~     not only to the vaccines but also to real HIV-1 particles and HIV-1-infected cells.~   "
185974|NCT01130363|"~     The class of proton pump inhibitor (PPI) medications such as omeprazole has proven extremely~     effective in the treatment and prevention of gastric and duodenal ulcers. Although the FDA~     approval for PPI therapy is limited to 6-8 weeks, many individuals remain on these agents for~     years, and human studies have suggested that long-term use of a PPI can result in~     enterochromaffin-like (ECL) cell hyperplasia, as well as being associated with the~     development of fundic-gland polyps of the stomach. These findings raise the concern of the~     possibility that long-term use of PPIs may predispose to the development of neuroendocrine~     tumors in patients. The investigators aim to examine clinical parameters, including history~     of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly~     the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during~     endoscopy. The investigators hypothesize that there is a correlation between fundic gland~     polyps of the stomach and the use of proton pump inhibiter medications.~   "
185975|NCT01130337|"~     This study will evaluate the disease free survival rate of a combination of capecitabine~     [Xeloda] and oxaliplatin (XELOX) with trastuzumab [Herceptin] in patients with resectable~     gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and~     Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle)~     will be administered for three cycles prior to surgery to resect the tumor. If complete~     resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three~     cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin~     alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in~     every cycle. The anticipated time on study drug will be 12 months.~   "
185976|NCT01130324|"~     The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to~     VIBATIV at any time during pregnancy. There are no mandated physician visits for the~     registry.~   "
186020|NCT01129739|"~     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells~     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg on the subjects~     for refractory anemia (RA) and refractory anemia with ring sideroblast (RARS) of~     myelodysplastic syndromes (MDS).~   "
185977|NCT01130311|"~     Tuberculosis is a global public health problem. One third of the world's population is~     infected with tuberculosis (TB) with almost 2 million deaths per year globally. According to~     the WHO, Pakistan ranks 8th amongst the 22 high TB burden countries, with an estimated~     prevalence is 263 cases /100,000 populations.~      In spite of effective therapy for drug sensitive TB, treatment failure occurs frequently~     leading to concerns for the emergence of multi-drug resistant (MDR) and extensively drug~     resistant (XDR) mycobacterial strains. Therefore in the recent years, interest has been~     generated regarding the role of adjuvant immunomodulating therapy for the treatment of TB.~      WHO has classified tuberculosis by disease severity into 3 distinct categories; mild,~     moderate and severe according to clinical presentations and host factors. Severity of disease~     has been linked to mycobacterium genotypes and with host factors such as vitamin D deficiency~      Vitamin D is a hormone produced by the body in response to sun exposure. Independent of it's~     effects on bone mineralization, vitamin D is recognized to have numerous immune modulating~     effects; some specific to mycobacterium tuberculosis. Therefore vitamin D may enhance the~     host immune responses against the pathogen. Vitamin D status can be accurately determined by~     measuring the serum levels of 25-(OH) D3. A recent systemic review and meta-analysis explored~     the association between low serum vitamin D and risk of active tuberculosis and concluded~     that patients with tuberculosis have lower serum levels of vitamin D than healthy controls~     when matched for sex, age, ethnicity, diet and geographical location.~      Vitamin D deficiency is not a life threatening condition. It usually is unrecognized or can~     present with generalized 'aches and pains' due to osteomalacia. The recommended dose for~     treatment of vitamin D deficiency is 200,000 IU/ month or 50,000 IU/ week, both given for 2~     months or until the serum vitamin D level is > 30 ng/ml. Bone mineral density changes are~     usually completed by 10 weeks of treatment.~      The investigators hypothesize that by replacing vitamin D in patients with active pulmonary~     tuberculosis, the 'Time to Recovery' can be shortened.Our aims are to determine whether~     replacing patients with insufficient and deficient levels of vitamin D affects the clinical~     outcome of the disease.~   "
185978|NCT01130298|"~     Single-center, single dose, open-label study in healthy male and female volunteers to further~     characterize the transfer potential of Testosterone Gel 1.62% formulation.~   "
185979|NCT01130285|"~     The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test~     (LCRT). In the process, the investigators will establish a bank of NBEC samples and~     corresponding blood samples from individuals demographically at increased risk for lung~     cancer.~   "
185980|NCT01130272|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of different~     doses of JNJ-27018966 compared with placebo in the treatment of patients with irritable bowel~     syndrome with diarrhea (IBS-d).~   "
185981|NCT01130259|"~     The following trial is designed to offer pre-approval drug access to iniparib in combination~     with gemcitabine and carboplatin in order to provide potential clinical benefit to patients~     with ER-, PR-, and HER2-negative metastatic breast cancer. This follows an ongoing Phase 3,~     multi-center, open-label, randomized study of gemcitabine/carboplatin, with or without~     iniparib, in patients with ER-, PR-, and HER2-negative metastatic breast cancer (protocol~     20090301).~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
185982|NCT01130246|"~     The objective of this study is to evaluate the safety and efficacy of short-term A-002~     treatment on morbidity and mortality when added to atorvastatin and standard of care in~     subjects with an acute coronary syndrome (ACS).~   "
185983|NCT01130233|"~     Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic~     assisted rectal surgery~      This is a randomized trial comparing the bladder and sexual function of patients who undergo~     laparoscopic and robotic assisted rectal resection for rectal cancer.~   "
185984|NCT01130220|"~     The purpose of this research is to explore the factors involved in brain cancer health care~     literacy needs.~   "
185985|NCT01130207|"~     The investigators will study people who are obese and will be treated by bariatric surgery.~     The investigators will test the hypothesis that some of the features of obesity are related~     to the bacteria in the gastro-intestinal tract.~   "
185986|NCT01130194|"~     Follicular lymphoma has historically been considered an incurable lymphoma. By combining~     multiple effective treatments, the investigators believe that prolonged disease-free survival~     is achievable in this disease. The investigators goal is to have at least 60-70% of our~     patients in first continuous complete remission 15 years from initiation of treatment.~   "
185987|NCT01130181|"~     Study hypothesis:~      High-dose vitamin D leads to a shorter hospital stay in critically ill patients~      Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol~     or placebo.~   "
185988|NCT01130168|"~     This study will test the relationship between CBP (central blood pressure) and PBP~     (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate~     extended release (ISMN ER) or Amlodipine besylate in participants with hypertension.~   "
185989|NCT01130155|"~     It is generally agreed that artemisinin-based combination therapy (ACT) is the malaria~     therapy of choice but there is much less agreement about the best ACT-deployment strategies.~     Countries are now beginning to adopt policies to enhance ACT deployment that aim to address 2~     key goals: (i) making ACTs more readily and speedily accessible to patients: or (ii)~     targeting ACTs to patients shown to have malaria parasitaemia.~      The Tanzanian Government has secured funding to address both ACT access and targeting on a~     national scale. Access is to be improved through the distribution of subsidised ACTs through~     private facilities and retail drug shops under the Affordable Medicines Facility-malaria~     (AMFm). Targeting is to be addressed through enhancing microscopy and introducing rapid~     diagnostic tests (RDTs) in health facilities at every level of the system.~      This study will evaluate these two interventions in 3 rural regions of Tanzania which are all~     expected to receive both interventions during the study period. The investigators will assess~     the effectiveness of the interventions in terms of coverage, equity, quality, adherence, and~     public health impact using a pre-post plausibility design based on before and after~     household, health facility and outlet surveys. The null hypothesis is that the interventions~     will have no impact on the coverage of prompt effective treatment for fever and malarial. In~     addition, the investigators will estimate the cost and cost-effectiveness of implementation~     from a health system and household perspective. Finally the investigators will explore the~     socio-cultural context and other factors that influence the implementation and outcome of the~     interventions.~   "
187922|NCT01104792|"~     The objective of this study is to evaluate the long-term safety, tolerability and~     pharmacokinetics of cariprazine in patients with schizophrenia.~   "
185990|NCT01130142|"~     Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with~     gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is~     designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in~     combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2~     portion will commence.~      Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled~     study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there~     is no option for patients receiving placebo to cross-over to IPI-926).~   "
185991|NCT01130129|"~     Consumption of a diet rich in fruit and vegetables is associated with a reduced risk of~     cardiovascular disease and the protective effect may be due to polyphenolic compounds~     contained within these foods. The mechanism by which polyphenols exert this effect is not~     clearly understood but research has focused on their potential to affect platelet function.~     The purpose of this study is to quantify the anti-clotting activity of a range of plant food~     extracts and component compounds.~   "
185992|NCT01130103|"~     This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and~     the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of~     the World Trade Center (WTC) attacks.~   "
185993|NCT01130090|"~     In patients under bi-level pressure support ventilation for obesity hypoventilation syndrome,~     this study aims to determine if it is better, in terms of efficacy and patient-ventilator~     synchronisation to use~        -  Spontaneous mode (S)~        -  Spontaneous/Timed mode (ST) with an intermediate back-up rate, slightly below the~          respiratory rate of the patient~        -  Timed mode (T), with a ventilator respiratory rate above that of the patient. This issue~          has to our knowledge only been marginally studied without any consensus.~   "
185994|NCT01130077|"~     The overall objective of this pilot study is to collect immunological and safety data~     following administration of vaccinations with HLA-A2. This data will be used to decide~     whether a larger study of clinical efficacy is warranted.~   "
185995|NCT01130064|"~     The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment~     with QAX576 in patients with persistent asthma not adequately controlled with inhaled~     corticosteroids and long acting beta2-agonists.~   "
185996|NCT01130051|"~     The purpose of this study is to evaluate and compare the relative bioavailability of a single~     0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1~     tablespoon) relative to the same dose given as an intact tablet to healthy subjects following~     an overnight fast. A secondary objective is to evaluate the safety and tolerability of this~     regimen in healthy volunteers. All study subjects will be monitored for adverse events~     throughout the study period.~   "
185997|NCT01130038|"~     There will be found differences in the issue of characteristic of play between Children with~     Development Coordination Disorder and Children with Typical Development.~   "
185998|NCT01130025|"~     The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the~     recurrence of VTE in patients with active cancer who have had an acute VTE episode.~   "
185999|NCT01130012|"~     Gestational diabetes mellitus (GDM)is a major health problem~        -  growing prevalence of obesity~        -  the older age of pregnant women~      A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.~        -  feasibility of an early intervention~        -  glucose tolerance at weeks 26-28~   "
186000|NCT01129999|"~     Intensive cognitive-behaviour interventions (CBT) combined with pharmacotherapy for smoking~     cessation are well established and have been proved to be efficacious. Nevertheless, they~     yield only long-term abstinence rates about 35%. Considering the high interest of smokers in~     alternative medicine, the availability of a broad range of treatment methods, of which~     smokers choose an intervention according to their preferences, might contribute to improve~     treatment outcome. While hypnotherapy (HT) is an already widely promoted alternative method~     for aiding cessation, considerable methodological shortcomings of studies on this topic limit~     the interpretability of the results. In 2006, the German Academic Advisory Committee for~     Psychotherapy released new guidelines that included HT as an acceptable treatment for smoking~     cessation. The committee conceded, however, that conclusions concerning its efficacy are~     restricted due to the heterogeneity of findings. Hence, further well-designed studies are~     required to better test the efficacy of HT in comparison to accepted treatments. This~     randomised, controlled trial aims to compare the efficacy of CBT and HT for smoking~     cessation. Further, the influence of moderating variables will be investigated. It is~     hypothesized that 1) participants receiving CBT will evince higher abstinence rates than~     those receiving HT, 2) levels of nicotine dependence, self-efficacy and motivation to change~     will moderate the intervention effects and 3) participants with high levels of suggestibility~     will evince higher abstinence rates in the HT-intervention compared to participants with low~     levels of suggestibility. 220 adult healthy smokers will be randomized to receive either CBT~     or HT. Both programmes will be conducted in 6, weekly, 90-minute group sessions. Participants~     will be followed up at 1, 3, 6, 9 und 12 month post-treatment. Generalized estimating~     equation models will be conducted to analyse group differences on abstinence rates. The~     models will include the above mentioned moderator variables.~   "
186001|NCT01129986|"~     An open-label, prospective, controlled, two-step approach, post-marketing clinical study,~     applying DermaStream with saline streaming, in conjunction with a sustained multi-compression~     wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower~     extremity.~   "
186002|NCT01129973|"~     the audiology has achieved a great advance, where currently speech pathologists act in~     private clinics and in public services, in addition to schools, colleges and universities. To~     observe the development of the area of Audiology in Brazil, we note that there is a growing~     number of new audiology procedures. In 1980 the practice of audiology was limited in~     hospitals, offices and private clinics, and in 1988 due to a new constitution that devoted~     attention to protection of health of workers, opened-if more than one field of work, the~     audiology occupational, because of the hearing losses induced by noise~   "
186003|NCT01129960|"~     The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate~     (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment~     phase.~   "
186004|NCT01129947|"~     DHEA supplementation has been used in women with infertility and diminished ovarian reserve.~     There is a small report in 5 women with POF that benefited from the use of DHEA over several~     months. The investigators aim to evaluate further the use of DHEA in women with Premature~     ovarian failure (POF).~   "
186005|NCT01129934|"~     Acute low back pain is a common cause for emergency department visits. Controversy remains~     regarding the optimal medication for acute low back pain relief. The investigators~     hypothesized that administration of pharmacological anxiolysis in addition to analgesia will~     improve pain relief and patient management in the emergency department.~   "
186007|NCT01129908|"~     The celiac disease (CD) is a disease with an immune and genetic component that is activated~     by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food.~      In the oral environment the investigators see enamel defects and recurrent ulcers.~      Celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical~     symptoms of the disease (such as diarrhea, stomach ache and weight loss).~      It has been assumed that the patients have less cariogenic diet, and that caries prevalence~     is not as high as in normal population.~      In celiac patients the investigators find enamel defects that are characterized with pits and~     deep fissures and sometimes the complete loss of enamel. These defects are classified by the~     grading of the CD related DED's (dental enamel defects) according to Aine. These defects are~     symmetrical defects in the permanent dentition, in teeth that develops at the same time. The~     cause is thought to be hypocalcaemia or genetic.~      These defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy~     population.~      Recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in~     healthy population.~      After changing the diet to a gluten-free diet, an improvement is seen in the presence of~     these ulcers.~   "
186008|NCT01129895|"~     Promoting Health by Self Experience (PHASE) randomized controlled trial~      Study Hypothesis:~      A personal experience in health promotion will affect the health prevention activities of the~     health providers and thus will impact their prevention activities toward their patients~     compared with a control (no-intervention) group.~   "
186009|NCT01129882|"~     Purpose: To continue to provide aripiprazole intramuscular (IM) Depot treatment (400 mg or~     300 mg) to subjects with schizophrenia completing the 52-week, open-label safety and~     tolerability Study 31-08-248.~   "
186010|NCT01129869|"~     Background:~        -  Understanding participants experiences as research volunteers is critical to improving~          the effectiveness of human participant protection programs and strengthening public~          trust in clinical research. Historically, studies that evaluate participants~          comprehension of the informed consent document or evaluate the informed consent process~          have only indirectly measured the quality of a participant s experience.~        -  Few studies have assessed the nature, quality and efficiency of the entire clinical~          research process from the participant s perspective. To address this need, researchers~          have developed a Clinical Research Participant Perception Survey to evaluate~          participants overall perceptions of clinical research.~      Objectives:~      - To validate the Research Participant Perception Survey questionnaire and revise it~     accordingly to produce a questionnaire that other researchers can use.~      Eligibility:~      - Individuals at least 18 years of age who have participated in at least one research~     protocol within the past 2 years. Participation may be completed or ongoing.~      Design:~        -  Eligible participants will receive a survey by mail and will be asked to complete it and~          return it in the stamped envelope provided.~        -  The survey will ask questions about the research protocol process, including~          participants positive and negative experiences of participating in the research~          protocol....~   "
186011|NCT01129856|"~     The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone~     phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in~     patients with dry eye.~   "
186012|NCT01129843|"~     India continues to be one of the countries with very high prevalence of anemia. In fact,~     National Family Health Survey-3 (NFHS-3,2005-06) revealed increasing prevalence of anemia in~     women and children, since NFHS-2 in 1998-99. In the backdrop of this alarming trend, the aim~     of this trial is to assess the effectiveness of a community based anemia management~     intervention ( curative and holistic) delivered to rural anemia women and girls(aged 13 years~     and above)in remote hilly villages (unit of randomization) in terms of change in anemia~     prevalence (unit of analysis) after 3 months of iron supplementation. This trial with a~     therapeutic component of Directly Observed Home Based daily Iron Therapy (DOHBIT) by local~     village volunteers is conceived as a whole community approach to improve the hemoglobin~     status of affected patients in remote villages.~   "
186013|NCT01129830|"~     This prospective study evaluates the effect of DHEA supplementation on markers of ovarian~     reserve in women with diminished ovarian reserve.~   "
186014|NCT01129817|"~     A randomized controlled trial of the efficacy of classification based cognitive functional~     physiotherapy according to the system proposed by Peter O'Sullivan as compared to manual~     therapy and exercise in patients with non specific chronic low back pain.~      The investigators hypothesis was that treatment targeted at the mechanism behind the problem~     from a multidimensional perspective would be superior to traditional treatment.~   "
186015|NCT01129804|"~     The Network Support project is part of an ongoing effort to improve treatment for alcohol~     dependent patients. The Network Support Project is designed to help patients change their~     social network from one that reinforces drinking behavior to one that reinforces sobriety.~      160 patients will be assigned to one of two treatments. Each of the treatments will last 12~     weeks. The first is a Network Support (NS) treatment designed to help patients develop new~     acquaintances and social networks. It is expected that alcohol dependent patients will~     benefit from increasing their contact with non-drinking people. This NS condition will be~     compared to a packaged CBT program for alcoholics (PCBT) that is designed to teach a number~     of skills to help people stop drinking, but does not address social networks per se.~      In order to better understand what is happening to the investigators patients, the~     investigators will be using daily computerized telephone calls to ask about people's~     experiences. This will be done both before and after treatment. Patients will also be asked~     to participate in follow-up interviews every 3 months for 2 years following the end of~     treatment.~   "
186016|NCT01129791|"~     The purpose of this small, short pilot study is to determine the feasibility (e.g.,~     recruitment, dose acceptance, retention) of a future longer trial comparing the effects of~     different types of milk (raw milk, cow's milk, nondairy-milk) on lactose maldigestion.~   "
186017|NCT01129778|"~     The purpose of this research study is to assess how safe, effective (how well it works), and~     tolerable (to put up with) the drug Zegerid is in reducing reflux episodes in patients who~     have both gastroesophageal reflux disease (GERD) and Barrett's esophagus. Zegerid has been~     approved by the US Food and Drug Administration (FDA) for the treatment of GERD. The~     investigators hope to learn the effectiveness of Zegerid for reducing the amount of acid~     reflux patients are experiencing in the esophagus (swallowing pipe).~   "
186021|NCT01129726|"~     Fiberoptic Intubation is the preferred technique to difficult airway. However, when performed~     by untrained anesthesiologists, bronchoscopic intubation has a high rate of failure. We want~     to know if the Transillumination-guided Fiberoptic Intubation technique can improves the~     success rate and time for tracheal intubation performed by inexperienced anesthesiologists;~     whether this technique improves the success rate and for normal intubations when performed by~     inexperienced anesthesiologists as well is unknown. Therefore, the authors compared the~     success rate and time of Fiberoptic Intubation versus the Transillumination-guided Fiberoptic~     Intubation performed by anesthesiologists inexperienced in Fiberoptic Intubation.~   "
186022|NCT01129713|"~     To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with~     Secretol 80/80 versus Nexium 40 mg daily.~   "
186023|NCT01129700|"~     Concurrent chemoradiotherapy (CRT)~        -  Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)~             -  ↓ ↓ ↓ ↓ ↓~                  -  Radical surgery 6 weeks after completion of chemoradiotherapy~                       -  ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5~        -  5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy~   "
186024|NCT01129687|"~     The investigators study is to investigate safety and efficacy of performing a planned~     incomplete removal of large acoustic neuroma tumors to decrease surgical morbidity and yet~     avoid tumor recurrence by post-operative radiation therapy.~   "
186025|NCT01129674|"~     The primary purpose of the study is to help answer the following research questions:~      How LY 2140023 can be tolerated by patients with Schizophrenia compared to standard of care~     treatment in 52 weeks time period.~      Whether LY 2140023 can help patients with Schizophrenia.~   "
186026|NCT01129661|"~     The purpose of this study is to assess the safety and tolerability of escalating doses of~     CSL112 after single intravenous infusions in healthy volunteers and to measure the~     pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.~   "
186027|NCT01129648|"~     To evaluate safety and efficacy of BCX4208 alone and in combination with allopurinol in~     subjects with gout.~   "
186028|NCT01129635|"~     Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and~     morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond~     to this intervention. There is retrospective evidence that placement of the left ventricular~     (LV) lead at the region of latest mechanical delay markedly improves response to CRT.~     However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT~     implantation. Impedance recordings from pacing lead tips allow for real-time assessment of~     mechanical motion and may represent a useful intraoperative tool to guide optimum placement~     of the LV lead during CRT implantation. This pilot trial will assess the use of~     intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead~     locations during CRT implantation.~   "
186029|NCT01129622|"~     This study is a primary investigation to determine the usefulness and safety of a short~     course of a relatively high dose of letrozole (a medication used to decrease the female~     hormone estrogen which is produced locally inside the breast after menopause) in improving~     the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in~     the breast by letrozole might help better identifying of suspicious areas in the breast and~     could assist radiologists in distinguishing between benign breast areas and cancer tissue.~     This might help reducing the rate of call backs and unnecessary biopsies for patients. We~     expect to enroll 20 healthy postmenopausal women in this study.~   "
186030|NCT01129609|"~     The primary endpoint is successful secondary endovascular treatment with the Talent Converter~     stent graft of subjects having received prior endovascular repair of infrarenal abdominal~     aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated Stent Grafts, in which~     there is inadequate proximal fixation, seal, overlapping of modular components or~     unattainable contralateral limb cannulation.~      Treatment success is defined as a composite of successful vessel access, successful insertion~     of the delivery system, successful deployment of the Converter stent graft at the intended~     treatment site and absence of Type I endoleak at the 1 month follow-up visit.~   "
186031|NCT01129596|"~     The purpose of this study is to investigate the following about donepezil hydrochloride~     administration in patients with mild or moderate Alzheimer's Disease in clinical practice:~     cognitive function, Functional Assessment Staging (FAST) score, adverse events/adverse drug~     reactions, and patient background.~   "
186032|NCT01129583|"~     This is a randomized double blind placebo controlled study to investigate the hypothesis that~     injection of botulinum toxin A into the muscles surrounding the elbow following the surgical~     treatment of an elbow fracture will reduce postoperative stiffness and improve function.~   "
186033|NCT01129570|"~     Milk thistle is an herbal drug that may have some liver protection properties and may reduce~     inflammation in the liver. It may also have anticancer effects. However milk thistle is not~     approved by the Food and Drug Administration for any medical purpose in the United States.~      It has not been used in patients with liver cancer previously, to our knowledge, but there~     have been many studies of its use in patients with hepatitis and cirrhosis. Some of these~     studies have shown that milk thistle may help reduce elevated liver function tests.~      Siliphos is a derivative of milk thistle that can be absorbed better than some other types of~     milk thistle. The investigators would like to perform a study to identify doses of siliphos~     that are safe to take in advanced liver cancer and to identify positive or negative side~     effects this compound may have. The investigators will be using this information in future~     studies to see if siliphos can be used as a therapy in patients with advanced liver cancer to~     reduce elevated liver function tests.~   "
186041|NCT01129466|"~     Purpose: To compare the change in nasal cell HO-1 expression induced by two different~     preparations of sulforaphane (SFN)-containing nutritional supplements Participants: Healthy~     nonsmoking young adults, age 18-35 Procedures (methods): This pilot study will use a~     randomized crossover design. Subjects will be randomized to receive either the equivalent of~     4 ounces/day of fresh broccoli sprouts (FBS) in food and tea, or the equivalent amount as~     broccoli sprout homogenates (BSH), for 3 consecutive days. Nasal lavage and blood samples~     will be obtained before, during and after this 3-day period. After at least a 2-week washout~     interval, the protocol will be repeated with the alternate supplement. The primary analysis~     will test the hypothesis that broccoli sprouts in food will increase HO-1 expression to a~     similar degree as the equivalent amount of sprouts in BSH~   "
186034|NCT01129557|"~     Primary Hypothesis: Aldosterone breakthrough will occur at a far lower frequency during renin~     inhibition (0-10% over 9 months), alone or in combination with an ARB, compared to~     conventional ARB therapy (35-45% over 9 months). The investigators hypothesize that~     aldosterone breakthrough occurs due to accumulation of active precursor substances, most~     notably angiotensin II, produced in response to conventional RAAS blockade with ACEinhibitors~     and ARBs. The investigators believe that direct renin inhibition (DRI) should minimize this~     accumulation and therefore significantly lower or possibly eliminate the breakthrough effect.~      Interruption of the renin-angiotensin-aldosterone system (RAAS) with angiotensin-converting~     enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs), alone and in~     combination, has become a leading therapy to slow the progression of chronic heart and kidney~     disease. Both types of drugs inhibit the formation of aldosterone, a hormone, which has been~     shown to have harmful effects on patients with chronic heart and kidney disorders. This~     treatment is effective but not perfect since, even after an initial improvement, many~     patients become worse over the long term. This may be due to an unexpected increase in~     aldosterone, a phenomenon called aldosterone breakthrough.~      The purpose of this study is to find out whether the use of a direct renin inhibitor (DRI)~     alone, or in combination with an angiotensin receptor blocker (ARB), will lessen the~     occurrence of aldosterone breakthrough since direct renin inhibitors inhibit the formation of~     aldosterone at a very early step. This study will compare the effectiveness of adding Diovan~     (valsartan) or Tekturna (aliskiren) or a combination of Diovan and Tekturna to the usual~     antihypertensive treatment. The investigators will follow blood pressure, aldosterone levels,~     and urinary protein levels over 9 months to evaluate which of these therapies is most~     effective for treating hypertension in patients with proteinuric kidney disease.~   "
186035|NCT01129544|"~     Researchers are working on ways to treat SCID patients who don't have a matched brother or~     sister. One of the goals is to avoid the problems that happen with stem cell transplant from~     parents and unrelated people, such as repeat transplants, incomplete cure of the immune~     system, exposure to chemotherapy, and graft versus host disease.~      The idea behind gene transfer is to replace the broken gene by putting a piece of genetic~     material (DNA) that has the normal gene into the child's cells. Gene transfer can only be~     done if we know which gene is missing or broken in the patient. For SCID-X1, gene transfer~     has been done in the laboratory and in two previous clinical trials by inserting the normal~     gene into stem cells from bone marrow. The bone marrow is the factory inside the bones that~     creates blood and immune cells. So fixing the gene in the bone marrow stem cells should fix~     the immune problem, without giving chemotherapy and without risk of graft versus host~     disease, because the child's own cells are used, rather than another person's. Out of the 20~     subjects enrolled in the two previous trials, 18 are alive with better immune systems after~     gene transfer. Two of the surviving subjects received gene corrected cells over 10 years ago.~      Gene transfer is still research for two reasons. One is that not enough children have been~     studied to tell if the procedure is consistently successful. Of the 20 children enrolled in~     the previous two trials, one child did not have correction of the immune system, and died of~     complications after undergoing stem cell transplant. The second important reason why gene~     transfer is research is that we are still learning about the side effects of gene transfer~     and how to do gene transfer safely. In the last two trials, 5 children have experienced a~     serious side effect. These children developed leukemia related to the gene transfer itself.~     Leukemia is a cancer of the white blood cells, a condition where a few white blood cells grow~     out of control. Of these children, 4 of the 5 have received chemotherapy (medication to treat~     cancer) and are currently in remission (no leukemia can be found by sensitive testing),~     whereas one died of gene transfer-related leukemia.~   "
186036|NCT01129531|"~     This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic~     neuralgia (PHN) - nerve pain.~   "
186037|NCT01129518|"~     This open label randomised controlled study will evaluate the induction of immunity following~     varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C~     (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial.~     Participants will receive either 0, 1, or 2 priming doses of a MenC-CRM197 conjugate vaccine~     or 1 priming dose of a MenC-TT conjugate vaccine in the first year of life, with all groups~     receiving a dose of a combination Hib-MenC-TT vaccine at 12 months, as well as all other~     concurrent routine vaccinations. All groups will also be further divided into 2 groups to~     receive their routine vaccines in either consistent or alternating limbs to assess the immune~     response to the concurrent infant routine immunisations administered in consistent versus~     alternating limbs. Immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24~     months of age.~   "
186038|NCT01129505|"~     Our longitudinal aim is to reduce childhood obesity using our two-pronged intervention~     program, which includes healthy food choices and increased physical activity initiated during~     pregnancy and re-instated in the early period after delivery for overweight and obese women.~     We will accomplish this with our family-based Nutrition and Exercise Lifestyle Intervention~     Program (NELIP) to promote healthy family living. An intervention targeting school-aged~     children on the importance of healthy lifestyles occurs too late to prevent childhood obesity~     and establish lifelong healthy body weights. To break this spiraling cycle of generations of~     unhealthy body weights in Canadian children, and to reduce the risk of future obesity-related~     health problems, it is necessary to prevent excessive pregnancy weight gain, high blood~     sugars in the mother and to promote a healthy lifestyle during pregnancy and early post~     delivery. With our NELIP team as a cornerstone, and our pilot data already collected with~     promising results, we foresee an opportunity over the next 3 years to contribute to changing~     patient care with emphasis on disease prevention and healthy family lifestyle initiation~     early in life to reverse the trend of childhood obesity. With a solid research-based~     initiative from the lab to the community by educating health care providers, future health~     care can be improved by putting prevention-based programs into practice.~      Healthy women = healthy babies = healthy families = healthy futures!!~   "
186039|NCT01129492|"~     The purpose of this study is to evaluate whether low-level Laser therapy is effective in~     ameliorating the thyroid function of patients with hypothyroidism caused by chronic~     autoimmune thyroiditis.~   "
186040|NCT01129479|"~     Cognitive impairment after stroke is common and has a major effect on morbidity and quality~     of life. Acetylcholinesterase inhibitors have demonstrated benefit in vascular dementia, but~     efficacy in treating more circumscribed cognitive deficits following stroke, such as aphasia,~     has not been systematically investigated.~      This study evaluated the efficacy of Galantamine (Reminyl) in subjects with chronic, stable~     non-fluent aphasia secondary to stroke. Subjects enrolled in a double-blind placebo-~     controlled cross-over study that employed a comprehensive battery of language tests and~     measures of general cognitive and behavioral status that will be used to control for factors~     that may influence language functioning. The primary study outcome was a within-subject~     comparison of changes in language function and behavioral scores between placebo and~     active-treatment phases (12 weeks each). Our hypothesis was that by increasing acetylcholine~     levels, and facilitating activity of other neurotransmitters affecting attentional systems,~     Galantamine would produce gains in both language and behavioral scores in patients suffering~     chronic effects in cognitive systems due to injury following stroke.~   "
186042|NCT01129453|"~     The purpose of this study is to determine whether CVD 1902 (a live, attenuated, oral vaccine)~     is safe and effective in the prevention of Salmonella enterica serovar paratyphi A infection.~   "
186043|NCT01129440|"~     The goal of this project is to conduct a community-based randomized clinical trial to compare~     the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride~     varnish applied every six months and fluoride releasing glass ionomer sealants applied~     annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.~   "
186044|NCT01129427|"~     Primary objective:~        -  Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on~          Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with~          pantoprazole 80 mg/day compared to given alone in healthy male subjects~        -  Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel~          is given either alone or concomitantly with pantoprazole~      Secondary Objective:~        -  Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either~          alone or concomitantly with pantoprazole~   "
186045|NCT01129414|"~     Primary objective:~        -  Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 mg/day) on~          Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with~          omeprazole 80 mg/day compared to given alone in healthy male and female subjects~      Secondary Objective:~        -  Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when~          clopidogrel is given either alone or concomitantly with omeprazole~   "
186046|NCT01129401|"~     This treatment outcome evaluation of the Stonewall Project will recruit 150 participants to~     complete a face-to-face assessment visit at baseline, 3-month follow-up, and 6-month~     follow-up to examine treatment outcome with respect to HIV risk and substance use.~   "
186047|NCT01129388|"~     Primary objective:~        -  Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on~          Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the~          morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours~          interval in healthy male and female subjects~      Secondary Objectives:~        -  Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when~          clopidogrel is given either alone alone in the morning, or in association with~          omeprazole in the evening at a 12-hours interval~   "
186048|NCT01129375|"~     Primary objective:~        -  Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on~          Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with~          omeprazole 80 mg/day compared to given alone in healthy male and female subjects~      Secondary Objective:~        -  Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when~          clopidogrel is given either alone or concomitantly with omeprazole~   "
186049|NCT01129362|"~     The purpose of this cohort study is to determine vaccine-specific rates of pertussis disease~     during the period of the study, among Wisconsin residents younger than 60 months of age (the~     Surveillance Population), and to descriptively compare the proportion of such persons~     vaccinated with Pentacel® vaccine who acquire pertussis disease to the proportion of such~     persons vaccinated with any other Diphtheria and Tetanus Toxoids and Acellular Pertussis~     (DTaP) vaccine who acquire pertussis disease.~      Primary Objective:~      To determine the rates and relative risk of pertussis disease among Surveillance Population~     members who have received Pentacel vaccine or another pertussis vaccine.~   "
186050|NCT01129349|"~     To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or~     recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and~     Maximum Tolerated Dose (MTD) To determine the pharmacokinetics (PK) of Oprozomib To explore~     the anti-tumor activity of Oprozomib in this patient population including the overall~     response rate (ORR), the duration of responses (DOR), the progression-free survival (PFS) and~     time to progression (TTP) To define the pharmacodynamics (PDn) of Oprozomib.~   "
186051|NCT01129336|"~     This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell~     (CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone~     metastasis.~   "
186052|NCT01129323|"~     The purpose of this study is to evaluate the effectiveness of allogeneic transplant after a~     reduced-intensity preparative regimen for patient, to evaluate survival, and to evaluate the~     side effects of this treatment. The patient will be in the study for two years for treatment~     and active monitoring. After treatment and active monitoring are over, the patient's medical~     condition will be followed indefinitely.~   "
186053|NCT01129310|"~     The investigators hypothesize IXO chemotherapy will have an improvement in response rate and~     acceptable toxicity for uncurable metastatic gastric cancer compared to historical controls.~   "
186054|NCT01129297|"~     Type 2 diabetes and obesity are both multifactorial diseases resulting from gene-environment~     interactions. However, this interaction, as well as the specific effect of each polymorphism,~     remains poorly understood.~      We now proposed a prospective cohort study to improve our understanding of the influence of~     phenotypic characteristics on gene expression in tissues involved in glucose and/or lipid~     metabolism by collecting different biological samples.~   "
186055|NCT01129284|"~     This study will examine the safety and effectiveness of ACTHAR Gel, when used to treat 15~     patients diagnosed with treatment resistant nephrotic syndrome.~      Nephrotic syndrome is a group of symptoms that includes low levels of protein in the blood,~     swelling of tissue (edema), especially around the eyes, feet and hands; and high plasma~     levels of cholesterol. It is caused by a variety of diseases and underlying disorders that~     damage the kidneys, resulting in excessive excretion of protein in the urine. These diseases~     damage the glomeruli, which are small blood vessels that filter wastes and excess water from~     the blood and pass them into the bladder as urine. As a result of protein loss in the urine,~     the blood is deficient in protein. Normal amounts of blood protein are needed to help~     regulate fluid throughout the body. Protein in the blood normally draws water from the~     tissues and into the bloodstream. When blood protein levels are low, the normal movement of~     water is reversed, and fluid is drawn from the blood and accumulates in the tissues. This~     excess tissue fluid causes the swelling and puffiness (edema) that is a symptom of nephrotic~     syndrome.~      Nephrotic syndrome is described as treatment resistant when a patient fails to achieve a~     sustained partial or complete remission after treatment with at least two first line~     therapies.~      The goal of this study is to determine whether injections of ACTHAR Gel (an FDA approved~     treatment for nephrotic syndrome) over a six month period will lead to a correction of~     treatment resistant nephrotic syndrome in these patients.~   "
186109|NCT01128582|"~     To determine if administration of Rozerem in comparison to a placebo reduces or eliminates~     gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic~     insomnia.~   "
187923|NCT01104779|"~     The objective of this study is to evaluate the efficacy, safety, and tolerability of~     cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.~   "
186056|NCT01129271|"~     Primary objective:~        -  Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet~          aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4~          days 75 mg/day) in healthy subjects~      Secondary objectives are to investigate the potential food effect on:~        -  ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel~        -  Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated~          doses of clopidogrel~   "
186057|NCT01129258|"~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK),~     and pharmacodynamics (PD) of PF-04991532 following multiple (14 days) escalating oral doses~     in patient wtih type 2 diabetes.~   "
186058|NCT01129245|"~     The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and~     non-steroidal anti-inflammatory drug) has on ovulation.~   "
186059|NCT01129232|"~     The purposes of this study are to test whether GAD vaccination can stop the progression of~     newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis)~     in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and~     finally try to detect viruses and virus receptors directly in the insulin producing beta~     cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).~   "
186060|NCT01129219|"~     This is a randomized, controlled; single-blind parallel group trial carried out with hip~     fracture patients, starting at 12 weeks post fracture. Patients were approached during their~     acute stay in hospital, followed without any extra intervention for 12 weeks, and then~     randomized in a 2:1 manner to either intervention or control for the next 12 weeks. After the~     first 12 weeks intervention the intervention group were divided into two groups and~     randomized to an new single-blind parallel group trial for further intervention.~   "
186061|NCT01129206|"~     RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving pralatrexate together with docetaxel may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving pralatrexate together with docetaxel~     works in treating patients with stage IV esophageal or gastroesophageal cancer who have~     failed platinum-based therapy.~   "
186062|NCT01129193|"~     RATIONALE: AR-42 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of AR-42 in treating~     patients with advanced or relapsed multiple myeloma, chronic lymphocytic leukemia, or~     lymphoma.~   "
186063|NCT01129180|"~     RATIONALE: Bortezomib and azacitidine may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with azacitidine in treating patients with relapsed or refractory T-cell~     lymphoma.~   "
186064|NCT01129167|"~     Pancreatic cancer often spreads through local invasion into local structures, including fat,~     blood vessels, nerves, and nearby organs (stomach, duodenum, spleen, bile duct). Local~     microscopic invasion is associated with recurrence of pancreatic cancer after pancreatic~     resection, such that even if the original cancer is surgically removed, microscopic areas of~     cancer often remain. Data on the patterns of local invasion by pancreatic cancer have not~     been published. In this study, The investigators hope to investigate the frequency of the~     various methods of local invasion of pancreatic adenocarcinoma. This would help the~     investigators better understand how pancreatic cancer spreads, and determine what cancers are~     not resectable.~   "
186065|NCT01129154|"~     Squamous Cell Carcinoma (SCC) is one of the most common malignancies in caucasian population.~     The effect of the immune system on the development of skin tumors has been demonstrated in~     transplant patients taking immunosuppressive agents (65 fold risk increase). It has been~     reported that activation of EGFR and RAS signaling pathways play an important role in disease~     progression maybe through downregulation of the immune system.~      The investigators want to treat unresectable SCC patients with an antibody against EGFR~     (Vectibix®, panitumumab). This antibody induces tumor regression in metastatic colorectal~     cancer and has been approved as single agent for this indication.~      The investigators want to measure the response rate but also analyze the modification of~     expression profile of some key proteins involved or supposed to be involved in the signaling~     pathways of EGFR and in the regulation of the immune system. Chemokines such as CCL27 have~     been shown to play a critical role in the skin-associated immune response by regulating T~     cell homing. Pivarcsi et al have reported that downregulation of CCL27 is mediated by~     activation of EGFR/RAS/MAPK signaling pathways.~   "
186066|NCT01129141|"~     This study continues the investigators' efforts to develop tinnitus management protocols for~     Veterans. More specifically, this study developed and evaluated an adaptation of Progressive~     Tinnitus Management (PTM) for use as a telephone-based program for Veterans and military~     personnel who have experienced TBI. This adaptation, called Tele-PTM, is a telephone-based~     program and has the potential of providing needed tinnitus services to Veterans with and~     without TBI for a relatively small cost and with minimal impact on individual VA hospitals.~   "
186067|NCT01129128|"~     The goal of this study is to determine if either of two, commercially available, Echinacea~     purpurea products stimulate the immune system. For the study, 60 healthy adults will be~     randomized to receive one of the two Echinacea purpurea products or placebo for 10 days.~     Blood will be drawn to assess immune markers just before beginning the study medication,~     during the 10 day course of medication and after completing the course of medication. It is~     postulated that adults receiving either of the Echinacea products will have evidence of~     immune stimulation and those receiving placebo will not.~   "
186110|NCT01128569|"~     We propose to use an inhaled allergen challenge model to explore the individual contributions~     of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS)~     combination product on protection from allergic triggers in asthma.~   "
186111|NCT01128556|"~     To evaluate the effect of BEPREVE compared to a REFRESH Tears Lubricant eye drop on the~     measurement of the wheal and flare from histamine skin prick testing. This is an open label,~     two-week, post-marketing study conducted on histamine responsive patients.~   "
187924|NCT01104766|"~     The objective of this study is to evaluate the efficacy, safety, and tolerability of~     cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.~   "
186068|NCT01129115|"~     This is a randomized, 26-week study of supervised exercise assessing three doses of exercise~     in sedentary individuals 65 years of age and over with age-related cognitive changes. A total~     of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control~     group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise~     spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%, 100%, or~     150% of the recommended exercise dose. Participants will be directly supervised during all~     exercise sessions for the first two months after which direct supervision will occur during~     at least one session a week. This is intended to provide increased flexibility while also~     maintaining direct contact with the participant to enhance adherence. Aerobic fitness,~     physical function, and cognition will be assessed at baseline and 26 weeks to examine the~     dose-response relationships.~   "
186069|NCT01129102|"~     The purpose of this study is to determine whether NPC-01 is effective in the treatment of~     dysmenorrhea.~   "
186070|NCT01129089|"~     The study aims to confirm the acceptability of lipid-based nutrient supplements (LNS) for use~     as nutritional supplements for pregnant and lactating women (PLW) or infants and young~     children (IYC) and micronutrient powder (MNP) for use as nutritional supplements for infants~     and young children in Bangladesh.We hypothesized that at least 75 percent of the test dose of~     LNS and MNP offered to PLW and IYC will be consumed by them.~   "
186071|NCT01129076|"~     Background:~        -  Thalassemia major (TM) is a chronic disorder that affects a person s ability to produce~          hemoglobin, resulting in anemia. Hemoglobin is a component of red blood cells that~          carries oxygen and nutrients to cells in the body. As a result, individuals require~          life-long blood transfusions and extensive medical management. Studies have shown that~          because of its demanding nature, TM might negatively affect an individual s quality of~          life, sense of self, and social integration, but little is known about affected~          individuals overall experiences with and perceptions of TM.~        -  TM is caused by a genetic change in the thalassemia gene. The disease is passed to~          children by parents who carry one copy of the altered thalassemia gene. The parents are~          called carriers of the condition and have a 25 percent chance of having a child with TM.~          It is possible to screen for carriers of TM and use this information for pregnancy~          planning and management.~        -  TM is common among people from South and South East Asia and is an important public~          health concern in Singapore. More research is needed to explore the lives of people with~          TM, and the societal perceptions that exist in Singapore about TM.~      Objectives:~        -  To describe the familial, social, and professional experiences of individuals with TM.~        -  To investigate the social messages being given out about TM in Singapore and the sources~          of those messages.~        -  To explore the impact of these experiences, perceptions, and social messages on~          individuals who have TM.~        -  To explore how the experiences and perceptions of individuals who have TM affect their~          life, sense of self, social integration, and compliance with medical treatment.~      Eligibility:~        -  Residents of Singapore who are 14 years of age or older, can speak English, and~          currently have TM.~        -  Parents of individuals with TM who are 14 years of age or older. Parents must be 21~          years of age or older, be able to speak English, and have had caregiving~          responsibilities for their child at some point.~      Design:~        -  All participants will have a one-time semi-structured interview, followed by a~          questionnaire to obtain demographic information.~        -  Interviews will be conducted in Singapore and are expected to last for 30 to 90 minutes.~        -  Individuals with TM will be asked about their own perceptions of TM; familial, social,~          and professional experiences involving TM; and their perceptions of others views and of~          social messages related to TM.~        -  Parents of individuals with TM will be asked about their experiences in caring for a~          child with TM, talking to their child about TM, telling people about their child s TM,~          and interacting with health care providers.~   "
186072|NCT01129063|"~     The objectives of the study are to:~        -  Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel~          and its active metabolite after a replicated single administration of 75 mg of~          clopidogrel in healthy male and female subjects~        -  Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after~          single administration of 75 or 300 mg of clopidogrel~   "
186073|NCT01129050|"~     The major purpose of this study is to examine the effect of two sources of dietary omega-3~     fatty acids, each given at two doses, on potential health benefits related to cardiovascular~     disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and~     flaxseed oil.~   "
186074|NCT01129037|"~     Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR)~     results to a high cancer cure rate and a good functional recovery. However, this long complex~     procedure is accompanied with considerable complications. Excessive fluid administration~     during this type of surgery has been connected with poor results. There is growing evidence~     that goal-directed fluid management (GDFM) might improve the results in high-risk patients.~      Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume~     administered to patients undergoing head and neck reconstructive surgery.~   "
186075|NCT01129024|"~     This is a Phase 2, multicenter, open-label, extension study to evaluate the safety of~     S-888711 in the treatment of subjects with immune thrombocytopenia. Patients who participate~     in this study must have completed the Phase 2 double-blind, randomized, placebo controlled~     study.~   "
186076|NCT01129011|"~     This study uses a randomized, double-blind, controlled design to demonstrate that PN400~     (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal~     ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric~     ulcers compared to naproxen alone.~   "
186077|NCT01128998|"~     Primary Objective:~        1. To define the recommended dose for phase II study of S-1 combined with sorafenib~        2. To evaluate the dose-limiting toxicities of the combination therapy~      Secondary Objectives:~        1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination~          therapy~        2. To investigate the impact of genetic polymorphisms of metabolic genes on the PK of~          sorafenib and S-1, respectively, as well as on the toxicity profile of the combination.~        3. To determine the changes of biomarkers between pre- and post-treatments.~   "
186078|NCT01128985|"~     The purpose of this study is to evaluate the pharmacokinetics (blood levels of the drug) and~     pharmacodynamics (effects of the drug on the body) of canagliflozin after oral administration~     to patients with type 2 diabetes mellitus.~   "
186079|NCT01128972|"~     An in situ model will be used to evaluate and compare enamel remineralization of bovine~     enamel specimens.~   "
186080|NCT01128959|"~     The purpose of this study is to assess the safety and tolerability of intravenous (IV)~     carbamazepine (CBZ) administered as multiple 15 minute infusions and a single 5 minute~     infusion to adult patients with epilepsy on stable higher doses of oral CBZ.~   "
186081|NCT01128946|"~     This study will use an oral in-situ caries model to study remineralization of enamel due to~     the action of different combinations of fluoride salts delivered from dentifrices.~   "
186082|NCT01128933|"~     The purpose of the study is to determine potential utility of renal fractional flow reserve~     in prognosis predicting after renal stent implantation.~   "
186083|NCT01128920|"~     The purpose of this study is to develop and test an intervention to reduce bacterial and~     viral infections among injection drug users.~   "
187925|NCT01104753|"~     Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with~     ulcerative colitis (UC).~   "
186084|NCT01128907|"~     Invasive Aspergillosis (IA) is a very serious fungal infection. Hematological patients are~     the most affected group. IA has a very high morbimortality due to its rapid progression and~     because it is very difficult to be early diagnosed. Diagnosis is used to be done too late or~     even post-mortem. They are two new methods (techniques) trying to make the diagnosis on an~     early stage: detection of Galactomannan antigen of Aspergillus species and real - time~     polymerase chain reaction (PCR) of its DNA in blood. IA in immunocompromised patients is~     mainly located in lungs, so our hypothesis is that in patients where the investigators~     suspect IA the investigators should find earlier Galactomannan antigen or real -time PCR of~     Aspergillus in respiratory samples such as bronchoalveolar lavage (BAL), and its detection~     could be useful for diagnosis.~      Objectives: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in~     bronchoalveolar lavage. To validate the routine utility of these tests in BAL as a diagnostic~     method of IA and investigate if Galactomannan Antigen and Real Time - PCR for Aspergillus DNA~     in bronchoalveolar lavage can optimize blood test sensibility.~      Methods: Prospective study. The investigators will include 200 patients. 100 of them will be~     hematological patients, neutropenic and at high risk to develop an IA. The other 100 will be~     patients without risk or no suspicion at all of IA. The investigators will perform a BAL in~     all patients. And blood detection of Galactomannan Antigen in hematological patients. The~     investigators will perform a standard microbiological culture of BAL and Galactomannan~     Antigen in both samples (bronchoalveolar lavage and blood). The investigators also will carry~     out Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage.~      Expected results: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in~     BAL with more specificity and making earlier diagnosis than in blood. The investigators also~     expect to implant these techniques in BAL in the routine for IA diagnosis in neutropenic~     patients.~   "
186085|NCT01128894|"~     This open-label study examines the efficacy and safety of albiglutide as compared with~     liraglutide in subjects with type 2 diabetes.~   "
186086|NCT01128881|"~     The primary objective of this study is to prospectively document the exposure to IMMUNINE and~     to monitor FIX inhibitors over a period of approximately 20 to 50 exposure days while~     receiving prophylactic treatment in up to 50 previously treated patients (PTPs) aged 12-64~     years and approximately 20 pediatric PTPs up to 11 years of age with severe (FIX level < 1%)~     or moderately severe (FIX level <= 2%) hemophilia B who are planned to enter BAX326 study~     250901, provided all eligibility criteria are met.~      In addition, this study will evaluate the efficacy, safety, immunogenicity, thrombogenicity,~     and health-related quality of life (HR QoL) of these subjects.~   "
186087|NCT01128868|"~     The purpose of this study is to compare the abductor muscle strength measured with a~     dynamometer in patients with reverse oblique inter- or subtrochanteric fractures treated~     either with a proximal femur locking plate or a trochanteric nail.~      Proximal femur locking plates stands for both the PF-LCP (Synthes) and the PeriLoc (Smith &~     Nephew). Trochanteric nails allowed in this study are the Proximal Femoral Nail Antirotation~     (PFNA), the Titanium Trochanteric Fixation Nail (TFN) and the Gamma Nail (GN).~   "
186088|NCT01128855|"~     The purpose of this study is investigate the pharmacokinetics, safety and tolerability of~     single subcutaneous administration of GSK2402968 in non-ambulant boys with Duchenne muscular~     dystrophy~   "
186089|NCT01128842|"~     This is an open-label, phase 1 study of ascending single cohort of neratinib (HKI-272)~     combination with capecitabine.~   "
186090|NCT01128829|"~     Several sugar-replacement sweeteners are currently on the market, including saccharine (ex.~     Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study~     is to examine wether non caloric sweeteners affects how well the body works to control blood~     sugar. The study includes detailed blood sugar testing after drinking liquids that may~     contain sucralose. The investigators hypothesize that drinking liquids with sucralose will~     effect the amounts of specific appetite-affecting substances naturally produced by the body.~   "
186091|NCT01128816|"~     Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the~     heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is~     associated with increased risk of hospitalizations and death. It is not known however whether~     treating SA reduces these risks. This study is looking at whether a respiratory device known~     as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations~     and death in subjects with HF and SA. Study subjects will randomly receive either their~     regular medications OR their regular medications plus ASV. They will be followed for~     approximately 5 years and information relevant to their health will be collected and~     compared.~   "
186092|NCT01128803|"~     The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of~     hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after~     treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The~     aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an~     approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous~     dendritic cells loaded with specific peptides of AFP.~   "
186093|NCT01128790|"~     The purpose of this study is to determine the effect of remote ischemic preconditioning on~     exercise capacity in patients with heart failure.~   "
186094|NCT01128777|"~     The total number of military personnel is over 3.5 million and approximately 43% have~     children. The deployment cycle can be associated with depression, anxiety, and behavior~     problems in children as well as psychological distress in the military spouse. Further, the~     health of family members can affect the physical and psychological functioning of the~     military service member during the deployment and re-integration periods. While research and~     federal funding has been dedicated toward developing treatments for the returning service~     member, intervention protocols for mental health problems in the children of military~     families have not been tested. In collaboration with the Family Readiness Program of the~     Rhode Island National Guard & Reserves, the purpose of this proposal is to develop a~     cognitive behavioral treatment protocol for adolescents experiencing depression, anxiety,~     and/or behavior problems associated with the deployment and re-integration phases of the~     military deployment cycle. This protocol will be created by modifying an NIH funded cognitive~     behavioral protocol for the treatment of adolescent mental health problems with initial~     demonstrated efficacy (PI, C. Esposito-Smythers). There are three primary aims in this~     project: 1) develop the manualized intervention protocol for adolescents experiencing mental~     health problems associated with the deployment cycle; 2) refine and pilot the intervention~     protocol with 12 families; and 3) test the intervention in a randomized pilot trial. To~     accomplish these aims, a two step sequence of treatment development is proposed. Stage Ia~     includes initial manual development, focus groups, therapist training, and an open pilot~     trial. Stage Ib includes a randomized pilot trial. Seventy-two adolescents and their~     caretakers will be enrolled through the Rhode Island Family Readiness program and randomly~     assigned to the experimental intervention or non-directive supportive therapy for their~     outpatient care. The experimental intervention includes 12 adolescent group sessions which~     address depression, anxiety, and behavior problems associated with the deployment cycle and~     12 parent group sessions that address stress management and parenting skills. The~     non-directive supportive therapy condition includes 12 adolescent and 12 parent group~     sessions which involve patient initiated discussions focused on issues surrounding military~     deployment and re-integration. Outcome will be assessed at post-treatment and 3 month~     follow-up. The long term objective of this research is to yield an effective outpatient~     intervention for teens of military service members experiencing mental health problems~     associated with the deployment and re-integration phases of the deployment cycle.~   "
186112|NCT01128543|"~     This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with~     Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is~     metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted~     therapy in the metastatic and relaps setting.~   "
186113|NCT01128530|"~     The purpose of this study is to determine the clinical efficacy, safety, and tolerability of~     a 250 mg BID oral dose of JNJ-32729463 compared with linezolid in subjects with complicated~     skin and skin structure infections (cSSSIs).~   "
188008|NCT01103661|"~     This is a multi-center, prospective open label, feasibility study evaluating the safety and~     efficacy of the combined ablation procedure for the treatment of longstanding persistent~     atrial fibrillation.~   "
186095|NCT01128764|"~     Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al.,~     1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of~     children and adolescents in the United States are obese as defined by a BMI above the 95th~     percentile, with more than 30% falling between the 85th and 95th percentiles (Ogden et al.,~     2008). Overweight children and adolescents are at increased risk for type 2 diabetes~     (Pinhas-Hamiel et al., 1996) and overwhelming risk for adult obesity (Guo et al., 1994).~     There is a substantial percentage of adolescents who are both overweight and depressed with~     estimates from clinical samples averaging 25%. Treatment of teens with comorbid medical and~     psychiatric conditions such as overweight/obesity and depression has received little to no~     attention in the psychosocial treatment research literature. Due to the large number of~     adolescents who are both depressed and overweight, developing a behavioral treatment that~     addresses both problems simultaneously has important public health significance. The purpose~     of this proposal is to combine treatments for depression and overweight to address these~     co-occurring conditions in one intervention. The long-term objectives of this research are to~     develop efficient and effective treatments for co-occurring physical and emotional disorders.~     The research program will be divided into 3 major phases: a development phase (Stage 1a), a~     pilot study phase (Stage 1b), and a revision phase. During the development phase (Stage 1a),~     a treatment for overweight teens and CBT treatment for depressed teens will be adapted into~     one integrated protocol that addresses depression using CBT techniques, an exercise~     component, and advice regarding healthy eating. As part of this phase, we will adapt existing~     intervention manuals and therapist training materials, and gain some initial clinical~     experience with the intervention via an open trial with 6 teens. During the randomized pilot~     study phase (Stage 1b), the integrated intervention will be compared to a control group~     receiving CBT treatment for depression alone (N=40 in total). During the pilot phase, the~     feasibility and acceptability of administering the program will be assessed. In addition, we~     will compare change in depressed mood at end of treatment and 6 month follow-up periods~     across the two groups. During the revision phase, the intervention manual will be further~     developed and refined, based on experiences and observations made during the development and~     pilot study phases.~   "
186096|NCT01128751|"~     In a randomized controlled trial patients undergoing aortic valve replacement are recruited~     into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce~     solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT),~     designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional~     device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3~     months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging~     (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the~     filter groups compared to the controls. Secondary endpoint is the number of acute ischemic~     lesions after CABG.~   "
186097|NCT01128738|"~     The primary objective of this study is to demonstrate superiority of single treatment of~     GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of~     treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal~     injections based on gravimetric assessment (measurement of spontaneous axillary sweat~     production) for axillary hyperhidrosis.~   "
186098|NCT01128725|"~     Beta amyloid immunoreactivity is probably due to a significant number of Ab catabolites~     corresponding to N-terminally truncated and Cterminally truncated or extended forms which~     display distinct propensity to aggregation. Very few things are known concerning the~     mechanisms and proteases by which they are generated. Furthermore, the link between~     truncation and toxicity has not been delineated.~      Finally, little is known concerning Ab fragments in biological fluids and whether they could~     be seen as early biomarkers and thereby, as putative targets for AD diagnostic. The present~     project will allow to examine the human biological samples and to identify various cohorts~     after complete clinical evaluation.~   "
186099|NCT01128712|"~     To prospectively demonstrate the superior anxiolytic effect of high dose pregabalin (PGB)~     therapy (450 mg/day) compared to low dose PGB therapy (150 mg/day) in subjects with medically~     refractory partial epilepsy not fully controlled despite treatment with 1-2 concomitant~     antiepileptic drugs (AEDs).~   "
186100|NCT01128699|"~     The investigators aim to demonstrate the efficacy and safety of subconjunctival injection of~     Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory~     glaucoma.~   "
186101|NCT01128686|"~     This is to evaluate the proportion of subjects who show good responses to LAM treatment in~     Korea.~   "
186102|NCT01128673|"~     Hundreds of babies in the world are being treated with brain cooling to prevent brain injury~     after they lose oxygen at birth. This study will use the newly developed information from the~     magnet resonance image to determine the actual temperature of the brain. This will enable us~     to determine if the brain is being uniformly cooled and if techniques that provide cooling~     need to be changed to improve the injury prevention from cooling.~   "
186103|NCT01128660|"~     The purpose of this study is to twofold. The investigators wish to introduce a new~     patient-descriptive parameter, the 'Fidelity Coefficient', and use it to assess and compare~     the overview of patient's medication possessed by the general practitioners and the~     pharmacies.~   "
186104|NCT01128647|"~     There is evidence that total carbohydrate oxidation during exercise is higher after ingestion~     of fructose:glucose mixture than after ingestion of equimolar amounts of glucose alone. This~     may possible contribute to improve performance, provided that the extra carbohydrate~     oxidation induced by fructose:glucose co-ingestion occurs in skeletal muscle. The present~     study aims at assessing the hypothesis that, during exercise, a substantial portion of oral~     fructose is converted into lactate prior to oxidation To identify the major pathways of~     fructose disposal, 7 healthy endurance trained male volunteers will be studied. For each~     participant the following measurement will be performed~        -  a measurement of maximal oxygen consumption (VO2 max) on an ergometric bicycle~        -  a 2 hour exercise protocol with oral administration of a glucose drink. 6,6-2H2 glucose~          (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate~          glucose and lactate kinetics. Indirect calorimetry will be performed to measure total~          carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body~          lactate oxidation~        -  a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g~          every hour) mixture. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25~          µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect~          calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2~          will be monitored to calculate whole body lactate oxidation~        -  a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g~          every hour) mixture with fructose labelled with 13C6 fructose to evaluate exogenous~          fructose metabolic fate and oxidation. 6,6-2H2 glucose (0.44 µmol/kg/min) will be~          infused to calculate glucose kinetics. Fructose conversion into lactate and glucose will~          be evaluated by monitoring the systemic appearance of plasma 13C-labelled lactate and~          13C-labelled glucose. Total exogenous fructose oxidation will be measured by monitoring~          13CO2 production.~      Based on these measurements, semi-quantitative estimates of total fructose oxidation,~     fructose conversion into glucose, fructose conversion into lactate, and oxidation of~     fructose-derived lactate will be obtained~   "
186105|NCT01128634|"~     The purpose of this study is to see if the Pharmacokinetics and the Safety Profile of~     GSK573719 and GSK573719/GW642444 are effected by concurrent dosing with the PGP inhibitor~     verapamil.~   "
186106|NCT01128621|"~     A study in type 2 diabetic subjects on stable metformin therapy to investigate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of co-administering single and multiple~     oral doses of GSK1292263~   "
186107|NCT01128608|"~     To determine the effect of intraesophageal high PCO2 solution as compared to acidic and~     saline solutions on subjects' heartburn sensation using stiumlus-response functions.~   "
186108|NCT01128595|"~     We propose to use an inhaled allergen challenge model to explore the individual contributions~     of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination~     product and its components on protection from allergic triggers in asthma~   "
186114|NCT01128517|"~     Overall Objective~      • To evaluate impact of maternal educational strategies (teaching sessions by trained lady~     health workers, verbal, pictorial and demonstrative) regarding appropriate complementary~     foods of infants, and assess their impact on nutritional status of after six months of~     educational intervention.~      Specific objective • To determine the impact of maternal educational strategies regarding~     complementary foods by assessing baseline weight, height and mid - upper arm circumference at~     2.5 - 5 month of age and then comparing it at 3, 6 and 9 months after enrollment.~      (Hypothesis; the investigators hypothesize that there will be a gain of 250 gram weight, 0.5~     cm in length and 0.5 cm in MUAC in infants whose mothers received the special education~     module for complementary feeding, as compare to the children whose mothers doesn't receive~     education on complementary food.~      Secondary objective~      • To determine the impact of maternal educational strategies regarding complementary foods by~     assessing morbidity (number of diarrhea and ARI episodes, at 2.5 - 5 month of age and at then~     reporting at 3, 6 and 9 months after enrollment).~      (Hypothesis; the investigators hypothesize that there will be 10% decrease in incidence of~     diarrhea episodes and ARI episodes in infants whose mother received the special education~     module for complementary feeding, as compare to the children whose mothers doesn't receive~     education on complementary food).~      ARI can be define as per IMCI guidelines. Increase breathing rate (age specific) along with~     cough, cold and or wheezing.~   "
186115|NCT01128478|"~     Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute~     pancreatitis. The study hypothesis is that early administered enteral tube feeding might~     reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute~     pancreatitis.~   "
186116|NCT01128465|"~     Certain kind of neurosurgical procedures require intraoperative alertness of the patient, for~     example to perform speech tests during brain tumor resection. With respect to anaesthesia, it~     is therefore required that the patient is asleep during the beginning and the end of the~     procedure, however fully awake in between. To do so, the anaesthetic propofol is used and an~     accurate knowledge of its pharmacokinetic and -dynamic (pk/pd) parameters is required to~     optimally control anaesthesia. However, diverse pk/pd-parameter sets have been described in~     the literature.~      The aim of the study is to investigate whether the pk/pd model proposed by Marsh et al. or by~     Schnider et al. more accurately describe the pk/pd of propofol during awake craniotomy.~   "
186117|NCT01128452|"~     This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled~     monotherapy study in patients with treatment-resistant major depression. After confirmation~     of treatment-resistance in a prospective treatment period with citalopram, each patient will~     be treated with either EVT 101 once daily or placebo for 28 consecutive days.~   "
186118|NCT01128439|"~     This study will estimate the incidence of invasive pneumococcal disease in members of the~     Northern Kaiser Permanente healthcare system during each of the 5 following introduction of~     Prevnar 13.~   "
186119|NCT01128426|"~     The purpose of the study is to expand the understanding of the safety profile of 13vPnC in~     routine use following licensure and introduction of the vaccine.~   "
186120|NCT01128413|"~     The short term goal of this study is to evaluate a non-invasive approach that optimizes~     intravenous (IV) fluid administration according to heart performance and results in surrogate~     improvements in morbidity and mortality via lactate clearance. Additional objectives include~     comparative assessments of methods for determining volume responsiveness and establishing a~     prevalence of volume responsive shock in the Emergency Department (ED).~   "
186121|NCT01128400|"~     There are many substances naturally present in the mouth that may help us taste fat in food.~     Two of these substances (lipases and CD36) will be examined in this study.~      The presence of fat in food increases food tastiness, therefore people often over-eat~     high-fat foods and gain weight. The purpose of this study is to determine if blocking lipases~     and some genetic variations in the CD36 gene will make fatty food less tasty so that people~     eat less. Our hypothesis is that Orlistat and a particular gene will increase one's ability~     to detect fat.~   "
186122|NCT01128387|"~     The overall study objective is to evaluate the dose limiting toxicities and the recommended~     phase II dose of Panitumumab when combined with the standard of care treatment with~     cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer.~     The investigators will also be assessing the ability of PET (Positron Emission Tomography)~     imaging to predict the degree of pathologic response.~      All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive~     radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and~     chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that~     approximately 30 patients enrolled will undergo an esophagectomy which is considered standard~     of care post radiation and chemotherapy. The surgery will allow us to compare this study~     regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with~     radiation therapy).~   "
186123|NCT01128374|"~     Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the~     population in the United States affected. Moreover, up to one-third of these individuals may~     not be aware of the diagnosis and, are not involved in treatment. In the Mexican-American~     population, prevalence rates may be up to 50%. Contributing factors such as poor education,~     low household income, language barriers and restricted access to medical services may~     increase this prevalence. The association between periodontal disease and diabetes has been~     well documented; however, interventional studies have resulted in conflicting conclusions on~     improvements in glycemic control following periodontal therapy.~      Diabetes and periodontal disease share common pathways in pathogenesis, such as their~     polygenic nature and immunoregulatory dysfunction. To answer these questions, we, the~     investigators, propose this randomized controlled trial designed to elucidate how treatment~     of periodontal disease can be used for preventive and therapeutic purposes in a diabetic~     population as well as to study the role of IL-1 gene cluster polymorphisms as a risk factor~     for the presence of periodontitis in a Hispanic T2DM population. Our central hypothesis is~     that the Mexican-American T2DM population in Texas is at risk for an increased presence and~     severity of periodontal disease due to the presence of Il-1 gene cluster polymorphisms;~     furthermore we suggest that providing non-surgical periodontal therapy to this group will~     decrease the bacterial load associated with disease and as a consequence, will improve~     glycemic control as measured by HbA1c values. Our long-term goal is to study risk factors~     associated with the presence of periodontal disease and to understand how the treatment of~     periodontal disease can be used for preventive and therapeutic purposes in a Hispanic type 2~     diabetic population.~   "
186168|NCT01127776|"~     The purpose of this study is to evaluate of functional tests and clinical findings with APOS~     System treatment in patient after bi-trimalleolar fracture of ankle. These functional changes~     will be evaluated AOFS, FAOS, SF36 and WOMAC scores, walking laboratory GAITRite and clinical~     examination.~   "
186169|NCT01127763|"~     This study investigates the effectiveness of combination of carboplatin and investigational~     agent RAD001 in triple-negative breast cancer.~   "
186124|NCT01128361|"~     The current project is a natural extension of a programmatic line of investigation into the~     relationship between exercise, brain aging, and AD that Dr. Burns has developed over the last~     four years. The current study will provide data to estimate expected effect sizes for power~     analyses and sample size calculations. It will also provide an opportunity to optimally~     design a larger trial that can be extended to multiple sites to more definitively examine the~     role of exercise as a therapy in AD. The current project's aims are an important and~     necessary developmental step given the lack of fitness data in AD and the limited knowledge~     of the mechanisms that may form the basis of an association between aerobic fitness and AD.~   "
186125|NCT01128348|"~     Half of US adults have no more than basic reading and numerical skills. A consequence is~     inadequate health literacy, which is associated with unsatisfactory patient-provider~     communication and poor health outcomes in chronic diseases, including asthma. We have adapted~     a patient navigator intervention to address asthma in high risk communities as a practical,~     immediate, and sustainable method of achieving effective health literacy in patients low~     health literacy. This intervention will lead to improved adherence and asthma control,~     attenuating health disparities so marked in asthma. It is compared for efficacy and~     cost-effectiveness with asthma education.~   "
186126|NCT01128335|"~     This study will assess the safety and efficacy of different doses of sotrastaurin when~     combined with tacrolimus for the prevention of acute rejection after de novo liver~     transplantation.~   "
186127|NCT01128322|"~     The aim of this trial is to determine the best dose combination of S-Amlodipine and~     Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a~     once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their~     monotherapy components and placebo, in patients with stage I or II essential hypertension(a~     mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).~   "
186128|NCT01128309|"~     The aim of the study is to test whether Generalized Anxiety Disorder (GAD) patients that~     participate in a Stress Reduction Intervention show a brain activation pattern (assessed by~     MRI) indicative of improved emotion regulation compared to an active control intervention.~   "
186129|NCT01128296|"~     The primary goal of the research study is to determine whether treating pancreatic cancer~     patients with hydroxychloroquine in combination with gemcitabine before surgery is safe. The~     secondary goal is to determine if this new treatment regimen can effectively treat pancreatic~     cancer. This study will test the safety and efficacy of this combination in two parts, or~     phases.~   "
186130|NCT01128283|"~     We will collect blood samples from patients with the diagnosis of sepsis and other ICU~     patients. We will describe the course of different mediator levels and organ injury markers~     and follow their progression throughout the course of the study.~   "
186131|NCT01128270|"~     This is a research study to look at how Dichloroacetate (DCA), and investigational drug and~     chloral hydrate are broken down in the body. The purpose of the study is to better understand~     how humans metabolize these two common chemicals that are widely present in the environment.~     The study focuses on how the drug chloral hydrate is broken down and how it effects DCA~   "
186132|NCT01128257|"~     This observational study will assess the compliance and persistence of patients, real life~     efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva]~     in comparison to oral alendronate generics in female patients with post-menopausal~     osteoporosis. The anticipated time of assessment is 12 months. The target sample size is~     5000-7000 patients.~   "
186133|NCT01128244|"~     Chronically inadequate B6 nutritional status is associated with aberrant one-carbon (1C)~     metabolism and health. Plasma pyridoxal phosphate (PLP) >30 nmol/L often has been considered~     to be the cutoff indicative of nutritional adequacy, with 20-30 nmol/L considered marginal~     deficiency; however, the current Recommended Dietary Allowance (RDA) value was based on a~     more conservative cutoff of 20 nmol/L plasma PLP. As shown by in the investigators~     preliminary data, biochemical perturbations occur when humans have marginal B6 deficiency~     consistent with plasma PLP of 20-30 nmol/L. A prospective study also showed that plasma PLP~     <23.3 nmol/L is associated with 1.8-times higher risk of recurrent venous thromboembolism~     than those with PLP >23.3 nmol/L. The mechanism by which low B6 intake is associated with~     risk of vascular disease is not known. Since B6-deficiency has little tendency to raise~     fasting plasma total homocysteine (tHcy) but yields an elevated tHcy response following a~     methionine load, low B6 nutriture may lead to repeated transient mild hyperhomocysteinemia~     following meal consumption. Several reports of associations between elevated plasma~     C-reactive protein (CRP) and low B6 status have raised the hypothesis that systemic~     inflammation is prone to occur during B6 deficiency or contributes to low B6 status. The~     investigators previously found that healthy humans in low B6 status caused by dietary~     restriction exhibited normal plasma CRP levels. The investigators also postulate that~     oxidative stress associated with low B6 status, coupled with impaired glutathione synthesis,~     contributes to such risk. These questions indicate the need for a more thorough understanding~     of the metabolic changes occurring in low B6 status from marginal B6 intake and from drug~     interactions such as in women using oral contraceptives.~   "
186134|NCT01128218|"~     Extent of resection is a very important prognostic factor affecting survival in individuals~     diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma~     tumor cells produces indistinct borders between normal and malignant tissues, and the lack of~     easily identifiable tumor margins confounds attempts at total resection. The investigators~     propose to identify the borders of malignant gliomas intraoperatively using oral~     5-aminolevulinic Acid (5-ALA) which results in fluorescence of the malignant cells and~     thereby provide an opportunity for more complete tumor resection.~      When exogenous 5-ALA is provided at increased concentration the tumor cells will become~     fluorescent under ultraviolet light. This feature identifies the tumor cells intraoperatively~     and facilitates complete resection.~      Data collection will include measurement of dose-limiting toxicity, tumor fluorescence, and~     tumor density. Data analysis will evaluate toxicity, sensitivity, and specificity of 5-ALA.~     Time-to-progression, one year survival rate and total survival will be measured as a function~     of the extent of resection. (Details below in Detailed Description.)~      Following completion of the phase 1 portion of this trial, an additional 15 subjects will be~     entered at the recommended phase 2 dose level in order to further define the above parameters~     at the recommended phase 2 dose level.~   "
186135|NCT01128205|"~     The objective of this study is to evaluate the level of control of cardiovascular disease~     risk factors, including blood pressure, blood lipid, and blood glucose, in out patients with~     type 2 DM in 6 representative regions in China: Northeast, North, East, South, Southwest and~     Northwest, measured by,~        1. Proportion of patients reaching adequate control of blood glucose~        2. Proportion of patients reaching adequate control of blood glucose and blood pressure, or~          blood glucose and blood lipid~        3. Proportion of patients reaching adequate control of all 3Bs, i.e. blood glucose, blood~          pressure, and blood lipid.~   "
186136|NCT01128192|"~     This clinical study will attempt to find out why in early studies in healthy volunteers,~     injections under the skin of pasireotide were associated with temporary increases in both~     fasting and post-meal glucose levels, along with possible increases in insulin and glucagon~     levels. Glucose refers to the amount of sugar in your blood and insulin and glucagon levels~     are amounts of hormones that lower and raise blood sugar.~      The purpose of the study is to evaluate the effects of pasireotide on insulin resistance and~     secretion. Insulin is a natural hormone made by the pancreas (a gland inside the abdomen)~     that controls the level of sugar in the blood. Insulin permits cells to use sugar for energy.~     Insulin resistance is the condition in which higher than normal amounts of insulin are~     necessary to allow the sugar to enter the cells. Insulin secretion refers to the amount of~     insulin produced by the body and released in the blood. Glucagon is a hormone (chemical~     substance produced by the pancreas gland in the body) which increases blood glucose.~   "
186137|NCT01128179|"~     To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo~     on serum intact Fibroblast Growth Factor 23 (FGF23) levels.~   "
186138|NCT01128166|"~     The goal of the MultiSENSE study is to collect chronic information from multiple sensors in~     an implanted device for evaluation in heart failure patients.~   "
186139|NCT01128153|"~     The purpose of this study is to determine whether the addition of saxagliptin to a patient's~     combination treatment of metformin and sulfonylurea for a 24 week period will provide better~     control of the patient's type 2 diabetes and will be well tolerated.~   "
186140|NCT01128140|"~     This study will develop and test a brief telephone-delivered motivational enhancement~     intervention for substance abusing military personnel who are not currently in treatment. The~     hypotheses being tested are that this intervention will prompt a willingness to participate~     voluntarily in a self-appraisal of substance abuse behavior and consequences, self-initiated~     change or enrollment in a treatment or self-help program, and cessation of abuse of alcohol~     or other drugs.~   "
186141|NCT01128127|"~     Background~      Despite the low prevalence of serious complications associated with non-steroidal~     anti-inflammatory drugs (NSAIDs) use, there is a widespread use of gastroprotective proton~     pump inhibitors (PPIs) in order to prevent adverse effects. Inappropriate prescribing of PPIs~     includes overprescribing for inappropriate indications and the misuse of first choice in~     their class in terms of efficacy, safety and cost. A series of recommendations, based on the~     best available scientific evidence, has been established to justify prophylaxis with PPIs~     associated to NSAIDs. Therefore, there is the need to encourage the incorporation of this~     knowledge to guide decisions of physicians with the objective of improving patient health and~     sustainability of the Public Health Service. Although since long ago there is a great concern~     regarding rational use of drugs, the available evidence for the most appropriate strategies~     to improve prescribing is scarce. Passive dissemination of research findings are generally~     ineffective and at best result in small changes in practice. Multifaceted intervention~     targeting different barriers to change are more likely to be effective than single~     intervention.~      Objectives~      The objective of this study is to evaluate the effectiveness of two educational multifaceted~     strategies aimed at improving PPIs prescription associated to NSAIDs use in primary care. We~     will also compare the cost-effectiveness of such strategies.~      Hypothesis~      It is hypothesized that a quality improvement intervention directed to primary care~     physicians will decrease inappropriate PPIs prescriptions associated to NSAIDs prescription.~      Methodology~      A three-arm prospective quasi-randomized controlled trial will test the effectiveness of two~     strategies for improving PPI prescription associated to NSAID in primary care context. Three~     of the Canary Islands will be selected and randomized to either a experimental multifaceted~     intervention (group education+audit-feedback+CCDSS) group, a experimental multifaceted~     intervention (audit-feedback+CCDSS) group, or a control group (usual intervention). From each~     of these islands, 6-8 primary care centers will be randomly selected to received the~     intervention practices. All family physicians working at each randomly selected primary care~     center were mandatorily included. Primary outcome measure is reduction of inappropriate PPI~     prescription. The efficacy of the intervention will be examined within a 3, 6 and a 12 month~     follow up.~   "
186142|NCT01128114|"~     The primary objective of this study is to evaluate the broad clinical benefit of dosing~     Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial~     response to existing therapy. Clinical benefit will be assessed with the Clinical Global~     Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the~     principles outlined in the CGI efficacy index. Improvement in clinical benefit will be~     defined as a decrease from baseline in CGI-CB.~   "
186143|NCT01128101|"~     Several studies indicate that chronic kidney disease patients give a high cardiovascular risk~     and have an intrinsic relationship with hypertension and cardiomyopathy: characterized by~     left ventricular hypertrophy and interstitial fibrosis. The reversal of left ventricular~     hypertrophy is associated with increased life expectancy in these patients. The renin~     angiotensin aldosterone system plays an important role in blood pressure control. Even~     patients using converting enzyme inhibitors inhibitors or angiotensin II blockers may~     experience the so called aldosterone breakthrough phenomenon (inappropriately called~     aldosterone escape). This phenomenon is documented in patients with heart disease and in~     chronic kidney disease. Spironolactone is a synthetic steroid that acts as an antagonist of~     aldosterone, which has historically avoided in chronic kidney disease patients, given the~     risk of hyperkalemia. However, its active metabolite, canrenone and spironolactone, are able~     to antagonize the binding of ouabain, a Na+/K+ATPase inhibitor, to its receptor. The~     Na+/K+-ATPase inhibition results in changes in sodium gradients, and increases the calcium~     influx through the transporter Na+/Ca+ in specific regions of the membrane. Spironolactone~     and canrenone in previous research were able to reverse left ventricular hypertrophy in~     chronic kidney disease patients on conservative treatment, which turn this drug and its~     metabolite potential tools for reversion of left ventricular hypertrophy in chronic kidney~     disease. The aim of this study is to verify the safety, tolerability and efficacy in the~     reversal of target organ damage from the use of spironolactone added to conventional~     antihypertensive therapy in chronic kidney disease patients on hemodialysis, in addition to~     measuring its ability to reduce left ventricular hypertrophy and arterial stiffness indices.~     Interventional randomized, double-blind, placebo-controlled study comprising two groups: one~     that will take 25mg of spironolactone associated with conventional antihypertensive therapy~     and another that will take spironolactone placebo associated with conventional~     antihypertensive therapy. Each group will consist of 30 patients. Clinical and laboratory~     investigations, as well as home monitoring of blood pressure, echocardiography, determination~     of pulse wave velocity, augmentation index, and central blood pressure measurement of serum~     aldosterone will be are evaluated before and after treatment that will last 12 months.~   "
186170|NCT01127750|"~     This study will assess tolerability and safety and health outcomes in relapsing MS patients~     taking FTY720.~   "
186171|NCT01127737|"~     Using focus group and cognitive interviews with organ transplant recipients, the~     investigators developed interactive workbooks: a) prevention by sun protection b) early~     detection by skin self-examination (SSE). The investigators hypothesis is if the patient~     learns by acquiring skills in a favorable environment, then the patient may reduce their~     anxiety, enhance self-efficacy and perform self-management by SSE and sun protection. The~     investigators also evaluate existing internet sources of primary and secondary prevention of~     skin cancer for organ transplant recipients.~   "
186144|NCT01128088|"~     Keyhole bowel surgery provides the patient with an improved outcome following surgery in~     comparison to more traditional surgery requiring a large cut. In order to further improve~     outcomes there are several variables that must be controlled before, during and after the~     operation. These variables are the correct pain relief, accurate control and measurement of~     the fluid that is given during the operation and the subsequent mobility following surgery.~     Previous research has already identified that an enhanced recovery program (careful control~     and structure to the patients journey) will reduce the length of stay and complications after~     an operation. Currently an integral part of the enhanced recovery program requires the use of~     an epidural (a thin tube in the spine) to provide continuous pain relief for up to 48 hours.~     Through research previously undertaken at the MATTU the investigators have shown that an~     epidural can lead to an increase in the length of stay and a delay in the return to normal~     bowel function. A reason for the use of an epidural is to suppress the stress response.~      The investigators aim to recruit patients from outpatient clinic undergoing keyhole bowel~     surgery in one unit and randomize them to receive one of two different pain relief methods~     after the operation. Patients will follow the same care as standard patients but their pain~     relief will differ between two already well established modalities. They will also receive~     different intravenous fluids. Blood will also be drawn at various intervals immediately after~     the operation for future analysis. The trial will be funded by the MATTU and will run for~     approximately 18 months. This trial will enable us to establish the stress response in the~     four groups and correlate it to the patient's outcome with an aim to refining the enhanced~     recovery program.~   "
186145|NCT01128075|"~     This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to~     evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects~     with relapsing multiple sclerosis (RMS).~      Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the~     eligibility criteria during a screening period of up to 28 days will be provided with an~     electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.~      The main purpose of this study is to evaluate treatment adherence for subjects with RMS over~     24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose~     cartridge.~   "
186146|NCT01128062|"~     Canthaxanthine is a naturally occurring carotenoid that has been a popular over-the-counter~     oral artificial tanning agent in Europe, Canada, and Australia since 1979. It is also used at~     low dosage as a food-colouring agent and as a therapeutic agent for photosensitivity~     disorders such as erythropoietic protoporphyria. Canthaxanthin retinopathy was first~     described in 1982 by Cortin et al. In Germany the office of the federal board of health~     refused the permit for oral tanning agents containing canthaxanthine in 1985. At that time~     the long-term course of the disease was not known. 25 years later the investigators did these~     long-term follow-up examinations.~   "
186147|NCT01128049|"~     Compare the objective tear film dynamic measurements in three different populations (MGD~     [Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry~     eye]) and the subjective experience before and after instilling a single drop of saline in~     each eye.~      Currently available office-based tests for dry eye do not reliably correlate with patients'~     subjective symptoms. This study is interested in assessing how individuals with these two~     different ocular surface diseases compare with the normal population when measured~     objectively using two different instruments.~   "
186148|NCT01128036|"~     The purpose of this study is to determine if the forehand location for sensor placement has~     less episodes of signal dropout than the finger sensor location. In addition, this study will~     evaluate two finger sensors, which utilize different technology to compare signal quality.~   "
186149|NCT01128023|"~     Cardiovascular (CV) disease is the leading cause of death in Canada. Fifty percent of all~     Tc-99m used in nuclear medicine is for the diagnosis of coronary artery disease (CAD) with~     SPECT myocardial perfusion imaging (MPI). The reduced supply of Tc-99m requires other tracers~     to be investigated. Tl-201 SPECT is available but generally accepted to be inferior to~     Tc-99m. Rubidium (Rb-82), a nonreactor produced tracer, is believed to have superior accuracy~     compared to Tc-99m and Tl-201 SPECT, with 5-20 times lower radiation dose. In the U.S. Rb-82~     generators have been FDA-approved since 1989 and are used increasingly for CAD diagnosis, but~     are still considered investigational in Canada.~      Objectives: To demonstrate that Rb-82 PET MPI is i) an accurate, cost-effective alternative~     to Tc-99m; ii) superior to Tl-201; iii) can be implemented in multiple Canadian centres for~     the diagnosis and management of CAD. Short term clinical outcomes of Rb-82 will be evaluated~     and compared to Tc-99m and Tl-201 SPECT MPI across Canadian imaging centres.~      Plan: Rb-ARMI is an innovative multidisciplinary, multi-centre imaging research initiative~     that builds on existing collaborative networks and Canadian industry partnership (DRAXIMAGE).~     Rb PET will be implemented, standardized and validated in 4 overlapping phases over 2 years,~     at 10 Canadian Centres.~      Impact: This project meets the expected goal to lead to clinical trial applications and~     clinical validation studies which compare novel radiolabeled probes with those in current~     practice, and to bring a new radiopharmaceutical to the clinic within a short time frame.~     Increased use of Rb-82 PET MPI has the potential to reduce the demand for Tc-99m by 10-40%,~     effectively increasing the available supply for other procedures, and improving the standard~     of care for many Canadians at risk of heart disease.~   "
186150|NCT01128010|"~     Immune dysregulations, including cytokines and chemokines secretions occurs in alcoholic~     liver disease. Serum levels and liver expression of CCL2 are increased in patients with~     alcoholic hepatitis but the role of this chemokine in the pathogenesis of alcoholic liver~     disease is nevertheless unknown. The aim of the study is to analyze plasma level and liver~     expression of CCL2 and their relation with liver disease severity and inflammatory infiltrate~     in our cohort of alcoholic patients. We studied also the association between -2518 CCL2~     polymorphism and the severity of alcoholic liver disease.~   "
186151|NCT01127997|"~     Second-meal phenomenon denotes the effect of a prior meal in decreasing the rise in blood~     glucose after a subsequent meal. This phenomenon occurs in normal subjects while it is not~     clear whether it is also observed in type 2 diabetic patients. This study aims to define~     whether the second-meal phenomenon occurs in type 2 diabetic patients. We will also seek for~     the mechanism.~   "
186196|NCT01127412|"~     The purpose of this study is to investigate whether stimulating physical activity during the~     first year of life influences growth and body composition, and stimulates motor activity and~     motor development~   "
186209|NCT01127230|"~     This scientific study is meant to establish correlation in Stromal Vascular Fraction (SVF)~     cell counts between our manual method of harvesting and Cytori's Celution automated system.~      Future scientific studies involving Adipocyte Derived Regenerative Cells (ADRCs) will be~     based on SVF cell counts from the more economical manual method of harvesting if this study~     shows good correlation.~   "
186152|NCT01127984|"~     The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in~     preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or~     ICD implantation/replacement which cannot discontinue dual antiplatelet therapy (i.e. ASA and~     clopidogrel, ASA and prasugrel) or anticoagulant therapy (i.e. warfarin, heparin, low~     molecular weight heparin).~      Fibrin-based sealant is available for local haemostasis. A recent study (Milic DJ et al, 2005~     Europace, 7: 374-379) has shown the efficacy of the fibrin sealant in prevention of pacemaker~     pocket haematoma in 40 patients undergoing pacemaker implantation who are receiving~     anticoagulant treatment.~      Patients with dual antiplatelet therapy (DAT) are prone to a high risk of bleeding during~     surgical procedures. Thus, the routine use is the discontinuation of DAT al least 4-7 days~     before the intervention. This practice may result in a high risk of thrombotic events in~     patients with coronary stenting.~      Recently, in our Center we started the use of a fibrin sealant for local haemostasis~     (Tissucol Baxter), and the investigators observed a reduction in the incidence of pocket~     haematoma complication, the need of vacuum drainage system, and the reduction of hospital~     stay.~   "
186153|NCT01127971|"~     This is an Aurora Health Care system registry of patients receiving accelerated partial~     breast irradiation and external beam.~   "
186154|NCT01127958|"~     The main objective of the study is to determine whether PCI for in-stent restenosis with a~     drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6~     month follow up.~   "
186155|NCT01127945|"~     This is a prospective, single-center, randomized, controlled, open-label, pilot study to~     evaluate the effectiveness of high dose statin loading in acute heart failure patients.~   "
186156|NCT01127932|"~     This is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral~     treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance~     Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial~     with 50 patients in treatment for SUDs comparing the CBT intervention to an enhanced control~     condition. Through this pilot randomized controlled trial, the investigators hope to not only~     obtain information about the feasibility of implementing these procedures in residential SUD~     treatment, but to also determine whether this intervention decreases the level of suicidal~     ideation, suicide attempts, hopelessness, and frequency of substance use relative to the~     control condition.~   "
186157|NCT01127919|"~     Obesity established in adolescence strongly predicts obesity for the remainder of adult life,~     and the consequences are potentially devastating, characterized by a lifelong burden of~     co-morbid conditions and depression. This study will provide an exposure to physical activity~     that is designed to teach and empower sedentary college age individuals to become physically~     active. The investigators will evaluate whether such exposure can result in lasting changes~     in exercise behavior and body composition. The study will also provide a better understanding~     of the genetic factors that influence persistence in an exercise program and that influence~     whole body response to exercise training. Altering the course of obesity in adolescence has~     the potential to reduce the adult prevalence of obesity and consequently attenuate the public~     health burden of overweight and obesity in the investigators population.~   "
186158|NCT01127906|"~     PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin~     that has been sensitized to heat by ultraviolet light. This study is designed to see if this~     is also true in man.~   "
186159|NCT01127893|"~     An evaluation of the long term safety of tanezumab when administered by subcutaneous~     injection every 8 weeks for up to 64 weeks~   "
186160|NCT01127880|"~     The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients~     with chest tubes for management of thoracic injuries in the reduction of the incidence of~     empyema as compared to placebo.~   "
186161|NCT01127867|"~     This study aims to determine if a supplement of an omega-3-fatty acid (docosahexaenoic - DHA)~     lowers inflammation in human fat tissue thereby lowering estrogen production and the~     potential risk for breast cancer. The investigators also aim to study how this occurs to~     discover the basis for other potential treatments to lower estrogen production in fat tissue~     and decrease the risk of breast cancer.~   "
186162|NCT01127854|"~     Recent investigations from this group have identified that genetic variants of genes~     associated with monogenic forms of nephrolithiasis are expressed in idiopathic calcium~     oxalate kidney stone patients and could influence stone forming risk. Utilizing patient~     samples from the Mayo Clinic Florida Kidney Stone Registry, we will demonstrate that~     expression of these heterozygous mutations in idiopathic nephrolithiasis act as genetic~     modifiers of disease presentation increasing risk of kidney stone formation. Complimented by~     the analysis of environmental and lifestyle risk factors, these studies will define~     environmental and genetic susceptibility factors involved in kidney stone formation and~     reoccurrence.~   "
186163|NCT01127841|"~     Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and~     response complete not confirmed.~   "
186164|NCT01127828|"~     To determine the effect of cultura probiotic yoghurt on number of responders to treatment~     during 8 weeks of treatment in comparison to placebo. To determine the effect of cultura~     yoghurt on change in total score of (IBS) irritable bowel syndrome severity index during 8~     weeks of treatment in comparison to placebo in IBS out patients.~   "
186165|NCT01127815|"~     Pancreatic cancer is a disease with an extremely poor prognosis. Such poor results are~     largely due to a high incidence of local or peritoneal recurrence even after curative R0~     resection. If occult microscopic metastasis or residual cancer could be predicted correctly~     and identify the high risk of peritoneal recurrence, we may have chance to treat these~     patients by different multimodal locoregional or adjuvant therapy to improve the treatment~     outcome.~   "
186166|NCT01127802|"~     The purpose of this study is to explore the changes of functional status, symptoms distress~     and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery.~   "
186167|NCT01127789|"~     The purpose of this study is to study motor learning and recovery of patients with brain~     damage caused by traumatic brain injury or stroke with transcranial direct current~     stimulation (tDCS). It is hypothesized that anodal tDCS on the lesion side and/or cathodal~     tDCS on the healthy side of motor cortex could improve the recovery of motor function such as~     learning.~   "
186172|NCT01127724|"~     Background: The frequency of recurrent aphthous stomatitis (RAS), the most common oral mucosa~     lesions seen in primary care, is up to 25% in the general population. Sublingual vitamin B12~     treatment, 1000 mcg per day for 6 months was found to be effective for patients suffering~     from RAS, regardless of the serum vitamin B12 level. However, the optimal therapeutic dose of~     vitamin B12 treatment remains unclear.~      Working hypothesis and aims:~      Aim-To assesses the influence of different vitamin B12 treatment doses on the frequency and~     severity of RAS episodes.~      Working hypothesis- The group receiving the higher dose of vitamin B12 treatment will have~     the lower frequency and severity of RAS episodes; the reaction will be faster.~      Methods: randomized, double blind, intervention study.~      Study population: 75 patients in three groups (total of 225 patients):~      Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months Group~     II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months Group I- will~     receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months Study design: Study~     participates will be followed through three study periods: The first period- three months~     prior to receiving active treatment, the second period- six month of active treatment (with~     randomization to study groups), and the third period- three month after finishing active~     treatment. Frequency and severity of RAS episodes will be recorded by the patient with~     aphthous diary that will be filled daily during all study period (12 months).~      Expected results: This study will allow us to identify optimal dose of vitamin B12 treatment~     that will achieve faster and longer remission of RAS episodes.~      Importance: This is a very common problem in the population. Study results will help to~     identify optimal doses of vitamin B12 needed to treat RAS.~      Probable implications to Medicine: study results are supposed to give faster and better~     treatment for RAS episodes~   "
186173|NCT01127711|"~     The Cohort of Swedish Men began in 1997, when all men born between 1918 and 1952 and residing~     in two counties in central Sweden received a questionnaire including about 350 items~     concerning diet and other lifestyle factors. A second questionnaire was sent out in 2008-09.~   "
186174|NCT01127698|"~     The Swedish Mammography Cohort began in 1987-1990, when 66,651 women living in two counties~     in central Sweden completed a mailed questionnaire that included items about their diet,~     parity, age at first child's birth, history of breast cancer in family, weight, height, and~     education. Follow-up questionnaires have been sent out in 1997 and in 2008-09.~   "
186175|NCT01127685|"~     The objective of this clinical trial is to in determining weight-bearing deficits following~     anterior cruciate ligament reconstruction.~   "
186176|NCT01127672|"~     The purpose of this investigator-initiated study is to clinically evaluate the efficacy of a~     new treatment for plantar fasciitis. This treatment consists of a platelet rich plasma~     injection into the origin of the plantar fascia. It is thought that plasma rich plasma~     injection will dramatically improve outcomes for patients suffering from plantar fasciitis.~      Subjects will be randomized by choosing a slip of paper from an envelope. This process will~     randomize 25 patients to the experimental group, and 25 patients to the control. The~     experimental group will undergo a blood draw, allowing for an injection of platelet rich~     plasma into the origin of the plantar fascia. The control group will undergo a corticosteroid~     injection into the plantar fascia as the sole treatment. Patients will be followed for three~     months for pain, and will fill out questionnaires at the initial visit prior to receiving the~     injection, as well as six and twelve weeks post injection.~      These questionnaires will give insight into functionality and pain changes that the plantar~     fascia is experiencing due to treatment.~      Subjects will be outpatients. Subjects may include employees, students, minorities, and~     elderly, although no subsets of these will be formed.~      Subjects will be between 18 and 89 years of age.~      In total, subject participation will last approximately 3 months.~   "
186177|NCT01127659|"~     The purpose of this study is to examine the effect of having testosterone deficiency in men~     with diabetes and with obesity. The study will also evaluate the effect of testosterone~     therapy. This will be done by comparing the changes in several body response indicators~     following treatment with testosterone in diabetic or obese-non diabetic men with low~     testosterone levels and comparing them to diabetic or obese-non diabetic men with low~     testosterone who are not treated with testosterone.~   "
186178|NCT01127646|"~     The main purpose of the study is to help to understand the effect on children and adolescents~     who are stable on treatment with atomoxetine or osmotic-release oral system (OROS)~     methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the~     medication for a maximum of 6 days over a 28-day study treatment period.~   "
186179|NCT01127633|"~     This study is an open-label extension study in Alzheimer's patients who have completed~     participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN~     (NCT00904683).~   "
186180|NCT01127620|"~     Double-blind phase: The objective of the study was to evaluate the efficacy and safety of~     Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of perennial allergic~     rhinitis.~      Open-label Phase: The objective of this extension was to evaluate the long-term safety of~     Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis~   "
186181|NCT01127607|"~     It is now well recognized that Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic~     disorder of childhood that extends into adulthood for many individuals. A number of~     impairments in daily life functioning have been identified in adults with ADHD, including~     marital distress, risky driving, and using less effective parenting practices (e.g., Barkley,~     2006).~      Specifically, some parents with ADHD have been found to use inconsistent discipline, less~     parental involvement, and less positive reinforcement with their children compared to parents~     without ADHD (e.g., Chen & Johnston, 2007; Chronis-Tuscano, Clarke, Rooney, Diaz, & Pian,~     2008). While there is some evidence that stimulant medication improves parental functioning~     for adults with ADHD, only one study has specifically explored the use of stimulant~     medication and parenting(Chronis-Tuscano, Seymour, Stine, Jones, Jiles, Rooney, et al.,~     2008).~      The purpose of this study is to explore whether or not the stimulant medication,~     lisdexamfetamine, improves parent functioning. Measures of parenting behavior, parental~     psychosocial functioning, and child psychosocial functioning will be collected. It is~     hypothesized that lisdexamfetamine will be associated with some improvement in these~     assessments.~   "
186182|NCT01127594|"~     The purpose of this study is to determine the safety profile of intra-arterial temozolomide~     administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities~     associated with this treatment. This study also aims to determine the maximum tolerated dose~     of intra-arterial administration of temozolomide during ILI that will be used in a phase II~     trial.~   "
186183|NCT01127581|"~     The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200~     microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone~     Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and~     induction of labor.~   "
186210|NCT01127217|"~     The purpose of this study is to evaluate the blood pressure lowering effects of an~     amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2~     hypertensive patients.~   "
186184|NCT01127568|"~     Objective: To use propranolol to treat established chronic post traumatic stress disorder~     (PTSD) by reducing reconsolidation of the reactivated trauma memory.~      Hypothesis: A series of treatments with propranolol, in comparison to placebo, will produce a~     significant reduction in PTSD symptom severity in participants with chronic PTSD.~      Study Design: This is a double-blind, placebo-controlled, randomized study. Methodology:~     Twenty-five participants per group with chronic PTSD will be recruited. On their first visit~     psychodiagnostic and psychometric evaluation will take place. In addition, script-preparation~     for the script-driven imagery procedure will occur. Following this, the participants will~     return each week for a period of 6 weeks to participate in the reactivation sessions with~     propranolol or placebo (participants assigned to the propranolol condition will receive~     propranolol throughout, and participants assigned to the placebo condition will receive~     placebo throughout). Two weeks later, the participants will return for a follow-up of the~     psychodiagnostic and psychometric evaluation, as well as psychophysiological assessment using~     script-driven imagery procedure.~      Data Analysis: A two-factor analysis of variance (ANOVA) for repeated measures will be~     performed on study completers. The Drug factor will have two levels: propranolol and placebo.~     The Time factor will have two levels: pre-treatment and post-treatment. We predict a~     significant Drug x Time interaction, more precisely a greater decrease in PTSD severity in~     the propranolol than in the placebo group. The psychophysiological data will be contrasted to~     a normative cutoff score for PTSD.~   "
186185|NCT01127555|"~     The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil,~     leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer~     who had failed gemcitabine.~   "
186186|NCT01127542|"~     The majority of patients with CLL are diagnosed with early stage disease (Binet stage A or~     Rai stage 0/I). Standard management of such patients is observation, and with median age at~     diagnosis of 72 and median time to progression of >5-10 years, many will never require~     treatment. In contrast, a proportion of patients have more aggressive disease, and over the~     last decade, a number of molecular factors have been identified that may be used to identify~     patients with poor prognosis disease . Each is associated with shortened time to treatment~     (typically less than 3 years in patients with 2 of more factors), reduced survival, with in~     the case of p53/ATM inactivation, resistance to treatment. Whether it is possible to improve~     the outcome of patients with CLL and adverse prognostic factors by early intervention with~     treatment is unknown. Several trials in the 1980's demonstrated that treatment of stage A CLL~     with conventional chemotherapy (chlorambucil) did not alter the natural history of the~     disease, although none of these studies stratified patients according to risk. The choice of~     alternative potential therapeutic agents is limited; they should be effective in patients~     with adverse prognostic factors, have acceptable toxicity, be able to overcome the drug~     resistance associated with p53/ATM inactivation and ideally be orally administered. Two~     recent phase II trials have demonstrated that Lenalidomide is effective in the treatment of~     relapsed/refractory disease. Importantly, both studies included a high proportion of patients~     with adverse prognostic factors including p53 inactivation. The principle objective of this~     study is to investigate the efficacy of Lenalidomide in achieving disease response (complete~     remission and clearance of minimal residual disease) in patients with poor risk early stage~     disease, together with assessment of safety and tolerability.~   "
186187|NCT01127529|"~     The overall objective is to collect and assess data on the treatment, safety, and treatment~     outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment~     registry.~   "
186188|NCT01127516|"~     The hypothesis of this investigation is that rate of isolation of resistant nosocomial~     pathogens can be explained by a combination of measures that include, among other things,~     antimicrobial drug use, infection control efforts, patient mix and antimicrobial stewardship~     efforts. The short term goal of this investigation is to improve our understanding of the~     relationships between antimicrobial stewardship program efforts (and actual antimicrobial~     drug use), and infection control efforts to the incidence rates of MSSA, MRSA, h-VISA and~     SA-MICcreep. The long term goal of this investigation is to design interventions that will~     improve antimicrobial drug use and decrease cross-transmission of resistant bacteria,~     resulting in a decrease in the rates of infection caused resistant hospital organisms.~   "
186189|NCT01127503|"~     This is an exploratory clinical investigation. The objectives of this study are to evaluate~     the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the~     treatment of psychosis in patients with velocardiofacial syndrome (VCFS).~   "
186190|NCT01127490|"~     The purpose of this study is to examine the characteristics of the nerves and the small veins~     in the skin of people with fibromyalgia. The investigators will then use this information to~     identify possible processes in the skin that may help explain why some people feel pain~     relief with the study drug (duloxetine) and others do not.~      Duloxetine affects certain chemicals in the brain called neurotransmitters. An abnormality in~     these chemicals is thought to be related to fibromyalgia. Duloxetine is a selective serotonin~     and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of~     depression. Duloxetine is approved for sale in the United States by the Food and Drug~     Administration (FDA) for the treatment of fibromyalgia.~   "
186191|NCT01127477|"~     The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for~     restoration and maintenance of hemodynamics during the investigational period in patients~     undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be~     administered from start of surgery until two hours after end of surgery. The study hypothesis~     is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely~     administered up to the dose limit.~   "
186192|NCT01127464|"~     DCVax-001 is a recombinant protein vaccine designed to prevent and potentially treat human~     immunodeficiency virus (HIV) infection. The vaccine is composed of a fusion protein~     containing a human monoclonal antibody specific for the dendritic cell receptor, DEC-205~     (CD205), and the HIV gag p24 protein. The vaccine is designed to target HIV antigens directly~     to endocytic pathways in dendritic cells (DCs) that allow for efficient processing and~     presentation of multiple HIV peptides on both MHC class I and II products, which will induce~     HIV-specific CD8+ and CD4+ T cells. This vaccine candidate must be combined with appropriate~     immunostimulants (adjuvants) to induce immunity to the antigen. In the proposed clinical~     trial we will use poly ICLC (Hiltonol) from Oncovir, Inc as the adjuvant.~   "
186193|NCT01127451|"~     The purpose of this study is to determine whether Patients with Stage IIIC and Stage IV~     Melanoma experience benefit when treated with Denileukin diftitox in two different dosing~     schedules.~   "
186194|NCT01127438|"~     The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol~     disodium) and to determine whether a dose lower than currently approved can provide effective~     moderate sedation required to complete diagnostic or therapeutic procedures.~   "
186195|NCT01127425|"~     A blinded randomized trial. Length of hospital stay, nursing hours and recovery after~     laparoscopic versus open colonic resection without fast track.~   "
186197|NCT01127399|"~     The prevalence of obesity and asthma has significantly increased over the past two decades.~     The purpose of this study is to try and understand the mechanism by which obesity leads to~     airway hyperresponsiveness (AHR), one of the defining features of asthma. This research is~     being done to determine how weight or body size affects airway size and airway smooth muscle~     (ASM) tone and function. The goal of the study will be to look at if and how, weight might~     affect lung functioning.~      The investigators hypothesize that low lung volumes in obesity lead to AHR by reducing airway~     caliber causing increased ASM tone with impairment in deep inspiration (DI) response similar~     to what is seen in asthma.~   "
186198|NCT01127386|"~     Cancer cachexia syndrome (CCS) is frequent, causing high morbidity and mortality in affected~     ones. The mechanism is catabolism caused by the tumour. CRP is a surrogate marker for~     catabolism. There are no effective treatment options against CCS. Lenalidomide, a derivate of~     thalidomide, is an immunomodulatory drug (IMiD®). One of its' main effect is a decrease in~     inflammatory cytokines. As CCS treatment, thalidomide has shown in a randomized controlled~     trial to stabilize lean body mass. The effect of lenalidomide in solid tumour patients was~     negligible although, there might be a decrease in tumour progression. However, even if~     lenalidomide may be uninteresting as an anticancer treatment it might affect CCS dynamics.~     Respective data are currently lacking. Therefore, a dose level where an anticancer effect~     could be expected was chosen (group A). Relevant anti-inflammatory effect may occur below the~     commonly used doses to achieve tumour control, which is expected to be the main anti-cachexia~     effect. Therefore, a second CRP-response guided treatment arm (group B) was chosen.~      Hypothesis: To test whether the response rate under new standard basic cachexia management~     will be at the estimated 5% and with lenalidomide (either fixed dose or CRP-guided dose) in~     addition to basic cachexia management at least 25%.~      The primary objective of this study is to assess the efficacy of lenalidomide on lean body~     mass and handgrip strength in advanced solid tumour patients with inflammatory CCS.~   "
186199|NCT01127373|"~     This study is being performed to understand the safety of a new radiation treatment called~     Multi-Beam Intensity Modulated Radiation Therapy ( IMRT). Currently, the standard way of~     giving radiation is with simplified IMRT, which uses only 2 beams of radiation.~     Multi-beam IMRT works by using 6-12 small radiation beams to give a more tailored or~     customized radiation dose to the breast, chest wall, and the lymph nodes. At the same time,~     multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered,~     especially when the internal mammary lymph nodes need to be targeted by radiation.~   "
186200|NCT01127360|"~     Age-related macular degeneration (AMD) is the most common cause of blindness in individuals~     over 50 years of age. Bevacizumab and ranibizumab are two agents developed by the American~     pharmaceutical corporation Genentech, both of which inhibit blood vessel growth factors.~     These drugs, when injected intraocularly, reduce the pathological growth of blood vessels in~     the macular area of the eye. Bevacizumab (Avastin) is an antibody developed for intravenous~     treatment of metastasized colon cancer. Ranibizumab (Lucentis) is an antibody fragment~     developed from a similar antibody. It was introduced 2006 as an effective treatment for wet~     AMD. Treatment costs are, however, up to 50 times higher compared to use of bevacizumab.~     Avastin has shown similar effects to ranibizumab, and has been used off-label in many~     countries, both before and after Lucentis received approval. There is thus a recognized need~     for large randomized studies to garner proper scientific proof of Avastin's effectiveness~     regarding exudative AMD.~      LUCAS is a randomized multicenter study, performed in Norway, comparing ranibizumab and~     bevacizumab use for AMD. The goal of the study was to demonstrate if the two agents were~     equivalent regarding both efficacy and safety. A total of 441 patients with objective~     evidence of wet AMD were randomized to a double-blind treatment with ranibizumab or~     bevacizumab over the course of 2 years. The treatment interval was determined by a Treat and~     Extend protocol.~   "
186201|NCT01127334|"~     Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator )~     for cardiac resynchronization therapy there is approximately one-third that do not respond.~     We believe that by using a simple technique that includes routine echocardiography that are~     normally performed in these patients could help us better understand how to program their~     device to reach better optimization.~   "
186202|NCT01127321|"~     The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult~     subjects with moderately to severely active systemic lupus erythematosus (SLE).~   "
186203|NCT01127308|"~     This is single dose study of radiolabeled [14C]-ertugliflozin (PF04971729, MK-8835) in~     healthy male volunteers to study the absorption, distribution, metabolism and elimination of~     ertugliflozin.~   "
186204|NCT01127295|"~     This is a biomedical study of interventional type, multicenter, inter-regional.~      Patients with hormono-depending breast cancer, for which an indication of adjuvant~     hormonotherapy treatment (according to the current treatments) was retained, will be enrolled~     in this study. The main objective is to estimate the correlations between pharmacokinetic and~     pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3~     years.~   "
186205|NCT01127282|"~     Influenza continues to inflict an important burden on health-care systems. The 2009 H1N1~     influenza virus first appeared in Mexico and the United States in March and April 2009 and~     has swept the globe with unprecedented speed.~      The aim of this study is to evaluate effect of supplement vitamin on the clinical course of~     patients with acute respiratory illness suspected novel H1N1 infection.~   "
186206|NCT01127269|"~     Primary Objective:~      Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) < 7% with no severe or~     nocturnal hypoglycemic episodes at 6 months~      Secondary Objectives:~        -  Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months~        -  Insulin glargine dose at 3 and 6 months~        -  Hypoglycemic episodes (all types)~   "
186207|NCT01127256|"~     The purpose of this study is to compare the efficacy and safety of zonisamide with~     carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.~   "
186208|NCT01127243|"~     The purpose of this study is to determine if women subjected to laparoscopic supracervical~     hysterectomy in a day-case setting would be less satisfied with the length of hospital stay~     when compared with women who had an overnight stay following their surgical procedure. The~     null hypothesis was that there was no difference in satisfaction with length of hospital~     stay.~   "
186211|NCT01127204|"~     The MONOD trial aim to evaluate the implementation of early antiretroviral treatment~     strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the~     initial proposed regimen after a successful one year treatment. The initial treatment is~     AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the~     following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once~     daily.~      The perspective of this project is to identify antiretroviral strategies to improve treatment~     access and adherence for children in sub-saharian Africa.~   "
186212|NCT01127191|"~     Land military missions generally combine prolonged walking/moderate-pace-running and other~     physical actions such as creeping, jumping, shooting,… which are associated with the direct~     carrying of high to severe loads of equipment and supplies (20-30 to 50 kg) by soldiers. For~     an infantry section, typical intervention phases last about 20-24 h and combine variable~     intensity grades. Consequently, military mission characteristics are an interesting~     investigation field of human fatigue. Previous studies have investigated human neuromuscular~     alterations after prolonged normal locomotion exercises [Millet et al., 2004, 2009], thus~     the aim of this study is to characterize the neuromuscular determinants of fatigue induced by~     a 24-h Simulated Military Effort (SME) and a 4-h Military Road March (MM), both performed~     with high load carriage. Additionally, the consequences of fatigue on physiological and~     biomechanical parameters of locomotion will be investigated.~   "
186213|NCT01127178|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of poly~     (ADP-Ribose) polymerase inhibitor E7016 when used with temozolomide (TMZ) in patients with~     advanced solid tumors and gliomas.~   "
186214|NCT01127165|"~     The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in~     children with epilepsy.~   "
186215|NCT01127152|"~     Circulatory failures are the main cause of admissions in the intensive care unit. It is~     recommended to prescribe to these patients an intravenous injection of catecholamine to~     correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to~     administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is~     replaced by a full syringe, it is named relay. This change may cause a flow interruption~     and hypotension.~      In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in~     common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4~     years, new devices are also used to make the relays. It is smart pumps allowing to manage~     automated the drug delays. This new method allows to not interrupt the drug flow. It could~     reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will~     show that the use of automatic method is the most sure medical strategy.~      Our study want to compare manual and automatic method watching the variations of medium~     arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP~     before the relay). Noradrenalin is the catecholamine most administrated so we choose to study~     only the relay for this drug.~   "
186216|NCT01127139|"~     The fixed combination of verapamil SR/trandolapril (Tarka®) is an effective, well-tolerated~     therapy for the treatment of essential hypertension in those who require more than one agent~     to achieve optimal blood pressure (BP) control. The endpoint is compliance with Tarka®~     treatment by number/percentage of patients continued on fixed combination Tarka therapy after~     six months. This Post Marketing Observational Study will be conducted in a prospective,~     single-arm, single-country, multicenter format. The investigational sites will be the~     cardiologists, the doctors of internal medicine and general practicians. Since this will be a~     Post Marketing Observational Study, Tarka® will be prescribed in usual manner in accordance~     with the terms of the local market authorization with regards to dose, population and~     indication as well as the local guidelines.~   "
186217|NCT01127126|"~     E: The pharmacological effect of Bryophyllum pinnatum could be shown on uterine smooth muscle~     cells, on spontaneous and oxytocin-stimulated contractions. Smooth muscle relaxation is not~     only required for preventing premature labour but also for symptom's relief of overactive~     bladder (OAB). According to previous preclinical and clinical studies, an inhibiting effect~     of Bryophyllum on OAB is assumed.~      20 women are included in this phase 2 drug study, treated with Bryophyllum pinnatum in form~     of the commercially available Bryophyllum tablets into capsules (verum: 3x2capsules/day) or~     lactose capsules (placebo: 3x2 capsules/day), 10 women in each group. Duration of the drug~     administration is 8 weeks.~      Primary endpoint is the reduction of micturitions per 24 hours (measured by filling in a~     voiding dairy), secondary endpoints are the improvement of quality of life (measured by using~     the King's Health Questionnaire and the ICIQ-OAB, two questionnaires, validated for the~     german language, for women with incontinence), increase of the micturition volumes and~     reduction of urge episodes (measured by the patients and recorded in a voiding dairy) and the~     registration of adverse events during the study phase. Ethics committee approval has been~     given 10th March 2010. - Trial with medicinal product~   "
186227|NCT01126996|"~     Neisseria meningitidis occurs worldwide as endemic disease1 and is a major cause of invasive~     infections such as meningitis and septicaemia. Three protein-polysaccharide conjugate~     serogroup C meningococcal (MenC) vaccines were developed in the late 1990's and an~     accelerated programme of clinical trials in the UK led to licensure of these MenC vaccines in~     1999 and these vaccines were introduced into the routine infant immunisation schedule at 2, 3~     and 4 months. However, children who were aged 1-18 years in 2000 only received a single dose~     of a MenC conjugate vaccine during the mass immunisation campaign.~      Previous studies have demonstrated rapid waning of MenC specific antibody concentrations and~     serum bactericidal antibody (SBA) titres following immunisation in young children. A~     cross-sectional review on rates of sero-protection against MenC disease in the UK has~     demonstrated that the majority of children who were immunised with a single dose of a MenC~     conjugate vaccine between the ages of 1-10 did not have protective titres of MenC SBA 7 years~     after the immunisation campaign. As this cohort of children reaches adolescence there is a~     risk of increased transmission of the organism and a resurgence of meningococcal disease in~     children who do not have protective levels of antibody. There is thus a need to conduct a~     study evaluating the changes in MenC SBA titres over time in children who received a single~     dose of a MenC vaccine in early childhood which is the main objective of this study.~   "
188199|NCT01101165|"~     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40~     mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.~   "
186218|NCT01127113|"~     Myocardial infarction (heart attack) is usually the consequence of rupture of a fatty~     'plaque' in a heart artery. The presence of this fat and debris causes the propagation of a~     blood clot and blockage of the artery. The heart muscle normally supplied by the artery~     becomes deprived of oxygen and, if starved for long enough, this area of muscle dies. Much of~     the heart muscle damage is caused by overactivation of inflammatory cells. Whilst~     inflammation can be beneficial in healing processes, there is accumulating evidence that~     overactivation of inflammatory processes contributes to further muscle damage and cell death~     during myocardial infarction. We have recently developed a means of labelling human blood~     cells with 'nanoparticles' of iron oxide which can then safely be reinjected into the blood~     to allow the cells to be tracked and seen in the body using a conventional magnetic resonance~     scanner.~      In the proposed study we aim to recruit patients with recent heart attacks to perform similar~     cell labelling and reinjection of labelled cells into the same volunteer's blood stream via~     the arm to track the fate of the blood cells over the course of days to months. We think that~     the labelled inflammatory cells will 'home' to the site of the heart attack and will be~     visible using magnetic resonance imaging (MRI) of the heart. We aim not only to highlight the~     role of inflammatory cells in myocardial infarction, but also propose that, if successful,~     this technique could be used in the future to assess the effects of antiinflammatory~     treatments currently being developed for the treatment of patients with heart attacks. The~     technique could also be extended to allow labelling of other cell types, including stem~     cells, to let us further understand how these cells may contribute to repair of damaged~     organs including the heart.~   "
186219|NCT01127100|"~     Gabapentin is a first line medication and fentanyl is second line medication in neuropathic~     pain. But, there is no head to head study on the efficacy of those medication in neuropathic~     pain.~      The hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not~     inferior to the gabapentin in neuropathic pain.~   "
186220|NCT01127087|"~     Hypothesis: Oral administration of the oxalate metabolizing enzyme Oxazyme (OC4) will degrade~     food-borne oxalate and hence prevent its absorption from the gastrointestinal tract. In~     addition, by reducing oxalate concentrations in the gastrointestinal fluid, oxalate secretion~     from blood to the intestinal tract may be increased. Both effects would decrease blood levels~     of oxalate, and hence oxalate excretion in the urine.~   "
186221|NCT01127074|"~     In the last few years there has been a great attempt to develop active immunotherapies for~     breast cancer patients (BCPs) using undefined as well as selected antigens to activate tumor~     specific T-lymphocytes. The purpose of this phase-I study was to determine the safety and~     feasibility of vaccinations with an allogeneic breast cancer cell line, KS24.22, genetically~     modified to express CD80 and Her-2/neu, and to evaluate the efficacy of inducing tumor~     antigen-specific immune responses in human leukocyte antigen(HLA)-A*02-matched patients with~     metastatic breast cancer.~   "
186222|NCT01127061|"~     The investigators propose a pilot randomized controlled trial to determine the safety and~     potential benefits of moderate intensity exercise in patients with hypertrophic~     cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a~     baseline cardiopulmonary exercise test will target an appropriately safe level of exercise~     intensity that will not cause significant arrhythmias or exacerbate symptoms and that~     exercise training for 4 months will result in significant improvements in peak oxygen~     consumption and quality of life, with neutral effects on the clinical characteristics.~   "
186223|NCT01127048|"~     The aims of this study are~        -  Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in~          children suffering from acute bronchitis accompanied by coughing~        -  Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison~          with placebo.~   "
186224|NCT01127035|"~     Respiratory allergy due to Alternaria is a relevant clinical problem, and specific~     immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is~     safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the~     efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double~     blind, placebo controlled fashion.~      Patients with rhinitis with/without intermittent asthma, and ascertained allergy to~     Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10~     months. Symptoms and rescue medication intake are recorded on diary cards from June to~     October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and~     at the end of the study. Alternaria spore count is also performed. Primary outcome is the~     change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue~     medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.~   "
186225|NCT01127022|"~     The purpose of this study is to investigate the effect of varied maternal choline intake on~     maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling.~   "
186226|NCT01127009|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone, etoposide, and~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving bortezomib together with combination~     chemotherapy may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with mitoxantrone, etoposide, and cytarabine in treating patients with~     relapsed or refractory acute myeloid leukemia.~   "
186228|NCT01126983|"~     To assess lead migration rates using different methods of securing leads during Spinal Cord~     Stimulation trial period.~      Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent~     implantation. Trial lasts less than a week, which gives the patient an opportunity to assess~     the effectiveness of the treatment.~   "
186229|NCT01126970|"~     To evaluate the weight loss effect and safety of 400 mg velneperit and 120 mg orlistat~     administered individually or combined three times per day for 24 weeks while on a reduced~     calorie diet (RCD) and also to evaluate the steady-state trough concentrations of velneperit~     (S-2367), velneperit (S-2367) tert-butyl OH, and velneperit (S-2367) tert-butyl OH-O~     glucuronide following 400 mg of velneperit (S-2367) three times per day and 120 mg of~     orlistat, either combined or separate.~   "
188770|NCT01093638|"~     The study will evaluate the effect of oral formulation of insulin on preterm infants, born~     between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and~     exclusion criteria established in this protocol.~   "
186230|NCT01126957|"~     Introduction~      Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA)~     in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics,~     barbiturates, and others, but propofol has gained popularity despite its potential to cause~     cardiac and respiratory depression. Obviously the optimal agent or combination of agents has~     not been identified. There are reasons to believe that a combination of ketamine and propofol~     may have advantages over other agents/combinations. These include better hemodynamic~     stability at equal depth of anesthesia with a combination of ketamine/propofol than with~     propofol alone, less respiratory depression with the combination in comparison to propofol~     alone, and preservation of respiratory drive with the combination. There is one study of~     ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the~     safety and effectiveness of the combination, but did not compare it to any other agents or~     combinations. The investigators designed a randomized, placebo controlled study to compare~     propofol to propofol and ketamine for adequacy of sedation and respiratory depression in~     Emergency Department procedural sedation and analgesia. The investigators hypothesis was that~     the combination of propofol/ketamine would produce better sedation and/or less respiratory~     depression than propofol alone.~      Methods~      Study design~      The investigators conducted a randomized, prospective, double-blinded study of all patients~     receiving procedural sedation. From April 2007 until July 2009 in the ED of a 274 bed~     university teaching hospital. The study was approved by the University of Missouri's~     Institutional Review Board and informed consent was obtained from all participants.~   "
186231|NCT01126944|"~     The prognosis for heart failure patients is bleak for the advanced stages of the disease,~     with a reported 6-month mortality rate of almost 50% in patients treated with chronic~     inotropic therapy. As well as its very severe prognosis, heart failure is a costly disease.~     Heart transplantation remains the reference treatment for the terminal stage of the disease~     but although this is an effective therapy, it does engender ethical, social, economic and~     legal problems. It also requires irreproachable and costly logistics, immuno-suppressor~     treatment and a lifetime of follow-ups. In particular, the number of donors has been going~     down steadily for several years in most countries which offer a heart transplant programme~     and some patients cannot take advantage of being added to a waiting list for a graft (age,~     co-morbidities…).~      It is in this context that, alongside the medical treatments for cardiac insufficiency, other~     therapeutic strategies were developed, including resynchronization and long-term mechanical~     circulatory support. The progress made in resynchronization is at several levels: better~     understanding of the action mechanisms, the development and improvement of equipment~     specifically dedicated to resynchronization and prospective and randomized clinical trials~     which have scientifically validated this technique.~      Simultaneously, many studies were published evaluating long term support with mechanical~     circulatory support (MCS), excluding light devices, as a bridge to transplant or an~     alternative to a transplant. It is also recognized that mechanical circulatory support with a~     new generation of continuous flow assist device improved the quality of life and functional~     capacity, with a reduced risk of device failure and infrequent need for replacement.~      The Achilles heel of cardiac resynchronization remains the 20 to 40% of patients who~     respond barely or not at all. Among this population of patients, some are not candidates for~     a transplantation and long-term mechanical circulatory support by axial pump is an~     alternative to be considered. We elaborated an original randomized pilot study for these~     patients in order to evaluate their survival and their quality of life, to define if they~     should be proposed a left ventricular assist device (LVAD)or not.~   "
186232|NCT01126931|"~     Wormwood is approved herbal medicine for the treatment of reduced appetite in Germany~     (Registration No.: 1339.99.99). Reduced appetite is observed in many chronic health disorders~     such as old age, immune disorders and cancer.~      Trial aims at observing beneficial effects of wormwood supplementation in various chronic~     disorders associated with reduced appetite~   "
186233|NCT01126918|"~     This three-site effectiveness trial will test whether a brief dissonance-based eating~     disorder prevention program produces intervention effects when college counselors,~     psychologists, and nurses are responsible for participant recruitment, screening, and~     intervention delivery under ecologically valid conditions.~   "
186234|NCT01126905|"~     Anaemia is a common complication of Chronic Kidney Disease (CKD) the management of which has~     been aided by the use of synthetic recombinant human erythropoietin therapy (r-HuEPO). This~     red cell stimulating agent creates the further complication of Functional Iron Deficiency~     (FID) where, despite normal iron stores, patients fail to respond to therapy as they do not~     possess enough available iron to meet the demand of increased red cell production. Effective~     response to r-HuEPO therapy depends on an appropriate monitoring of 'available' iron levels.~      Previous research into the clinical utility of testing for reticulated haemoglobin~     concentrations (Ret He) instead of Serum Ferritin and Transferrin Saturation analysis has~     indicated an advantage as an iron deficient prognostic marker however, further knowledge is~     required on the use of this new laboratory test (RetHe) to predict Functional Iron Deficiency~     (FID) level and to study it's relationship with responses to therapy.~      This proposed study aims to estimate a local working Normal (non deficient) and Iron~     Deficient Reticulated Haemoglobin Content (RET He) reference range from surplus anonamous~     samples. Routine monthly blood samples from Pre Dialysis and Haemodialysis patients will be~     used to evaluate the sensitivity and specificity of the RET He test compared to current~     laboratory tests and investigate its predictive ability for Functional Iron Deficiency in~     these patients.~      Studying , measuring and statistically analysing the change in the RET He parameters in~     Haemodialysis and Pre Dialysis patients over 3 months will look for evidence of a direct~     relationship between RET He values and the patients response to therapy. The data will be~     used to provide a predictive picture of what levels of RET He indicate Functional Iron~     Deficiency.~      The introduction of this test (RetHe) may provide clinicians with a one sample/one test~     control over iron therapies and ensure the patient gets the most benefit from erythropoietin~     therapy.~   "
186235|NCT01126892|"~     A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in~     blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and~     efficacy of Nilotinib.~   "
186236|NCT01126879|"~     RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This randomized phase II trial is studying how well genistein works in treating~     patients with prostate cancer.~   "
186244|NCT01126775|"~     Silent strokes are more frequent than clinical apparent strokes and can be detected~     noninvasively by MRI-investigations of the brain. Persons with silent strokes have a~     considerably increased risk for clinical apparent strokes as well as for the development of~     dementia. Intention of the study is the detection of silent strokes and microbleedings by~     standardized cranial MRI in 1000 participants (500 high-risk and 500 low-risk persons for~     cerebrovascular accidents) after a standardized neurological and neuropsychological~     examination. Results will be the base of early detection and early preventive strategies of~     cerebrovascular accidents in high-risk persons.~      In the course of a systematic follow-up examination without MRI the same 1000 patients (500~     high-risk and 500 low-risk persons for cerebrovascular accidents) will be reinvited to the~     sites. In addition to the standardized neurological and neuropsychological examinations a~     surrogate parameter of nephropathy, microalbumin, will be examined as this parameter could be~     helpful in forecasting cerebral microangiopathy. The clinical investigation will be expanded~     by several tests in order to assess symptoms of cerebral microangiopathy.~   "
186237|NCT01126866|"~     The purpose of this clinical trial is to primarily assess the efficacy of an intensified~     chemotherapy consisting of a combination of FOLFOXIRI + bevacizumab. The main focus will be~     laid on the rate of patients who achieve secondary complete (R0)-resectable metastases.~      The FOLFIRI + bevacizumab as well as the FOLFOXIRI regimens have been shown previously to be~     both effective in the treatment of advanced CRC with having manageable toxicities. Therefore,~     an intensified chemotherapy combining these two standard regimens might be a promising~     therapeutic approach improving the treatment of metastatic disease and outcome of CRC.~      Patients with advanced colorectal carcinoma of UICC stage IV, and liver and/or lung~     metasta¬ses only, which are not optimally resectable, will be enrolled in this single-arm~     phase II study.~      A minimum of 4 cycles (=8 weeks) of chemo¬therapy prior to surgery is mandatory for all~     patients. However, patients may withdraw from the study at any time upon their own request.~     Treatment with preoperative chemothera¬py will continue until 2-4 weeks prior to surgery with~     the last application of bevacizumab (only FOLFOXIRI) 4 weeks before surgery, at longest 16~     cycles (= 32 weeks) for candidates not eli¬gible for surgery. Treatment will be discontinued~     prematurely at disease progression or unacceptable toxicity.~      As secondary endpoints the acute and perioperative toxi¬city of preoperative chemotherapy~     according to NCI CTCAE v 3.0 including all peri-and post-surgical complications as well as~     progression free survival and overall survival and quality of life will be assessed.~   "
186238|NCT01126853|"~     Hepatitis B is a vaccine preventable infection which can be transmitted through occupational~     exposure. Approximately 15% of patients will not respond to an initial series of vaccination.~     Of those re-vaccinated approximately fifty percent will respond. On the basis of poor~     response to a third series, repeat vaccination is not recommended and non-responders are~     considered vulnerable to infection. Cardell studied the use of double dose combination~     hepatitis A and B vaccine (Twinrix) in non responders who had received four or more doses~     previously and found a high response rate suggesting this vaccine and dose could be~     effective. The investigators study seeks to duplicate the findings of Cardell, using a more~     strict definition of non-responder (6 or more previous doses).~   "
186239|NCT01126840|"~     Objectives:~      Specific Aims:~        1. Researchers will evaluate and compare predictors of health-related quality of life (QOL)~          among colorectal cancer (CRC) survivors who have Lynch syndrome (LS) with those patients~          who have sporadic CRC using both quantitative and qualitative methodology.~           a. In both CRC groups, researchers will evaluate cancer preventive and health behaviors,~          including lifestyle factors and screening, psychosocial factors, including mood, family~          functioning, coping style, anxiety, depression, and social resources, and health care~          system factors, including interactions with health care providers and service~          utilization.~        2. Researchers will compare the experience of first-degree relatives (FDRs) of patients who~          have LS with that of FDRs of patients who have sporadic CRC using both quantitative and~          qualitative methodology.~           a. Researchers will evaluate all of the domains listed above, as well as anticipatory~          grief, assessment of caregiving responsibilities, and fear of cancer in FDRs of patients~          with LS-related and sporadic CRC.~        3. Researchers will examine CRC patients from both groups and their FDRs using dyadic~          analyses in order to evaluate the similarities and differences in their survivorship~          experience.~        4. Researchers will evaluate the preventive and health behavior of patients who are~          non-conclusive for Lynch syndrome and their family members. They will examine their~          screening behavior and will explore how the interaction between the patients and their~          relatives affects the relatives' screening behavior. They also will examine how these~          non conclusive LS patients and their family members perceive their risk for LS-related~          cancers.~   "
186240|NCT01126827|"~     The purpose of the study is to investigate the efficacy of mindfulness-based~     cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar~     disorder, by comparing MBCT to supportive psychotherapy. Patients who participate in this~     study will be randomly assigned to receive either~        1. state of the art group MBCT, or~        2. supportive group psychotherapy (which is considered part of the standard care available~          to patients at MGH).~   "
186241|NCT01126814|"~     This is a Phase I-II study evaluating the toxicity and efficacy of imatinib combined with~     mitoxantrone, etoposide and high-dose cytarabine reinduction therapy in relapsed and~     refractory AML. Patients will be treated initially at a 200 mg dose of imatinib; if~     tolerated, the imatinib dose will be escalated in subsequent cohorts to 300 mg and 400 mg.~     Once the recommended dose is determined, the remaining patients will be treated at that dose,~     to evaluate the antileukemic activity of the regimen. Patients achieving complete remission~     will receive consolidation therapy with imatinib combined with high-dose cytarabine and~     mitoxantrone, followed by maintenance imatinib.~   "
186242|NCT01126801|"~     This protocol is a controlled study of estradiol therapy in early postmenopausal women with~     and without frequent hot flashes that will be used to determine whether hot flashes are an~     important intermediary in the generation of menopause-associated depression.~   "
186243|NCT01126788|"~     This study is designed to test two hypotheses:~        1. The PADnet+ testing system produces clinically equivalent results as the Parks Flo-Lab~          testing system in a group of patients referred for evaluation of PAD of the limbs when~          performed by a Registered Vascular Technologist (RVT).~        2. The PADnet+ testing system produces clinically equivalent results when the testing is~          repeated on the above patients and performed by staff specifically trained on the use of~          the PADnet+ system but are not vascular technologists nor hold the RVT certification.~   "
186245|NCT01126762|"~     The overall goal of this project is to establish a pilot study to develop and refine an~     intervention to promote consumption of fish low in mercury and high in n-3 PUFA among~     pregnant women. The investigators will demonstrate our ability to recruit pregnant women,~     influence their fish consumption, and measure changes in nutrient and toxicant biomarkers.~   "
186246|NCT01126749|"~     The purpose of this study is to determine whether Patients with Locally Advanced or~     Metastatic Bladder Cancer who receive Eribulin Mesylate Administered in Combination with~     Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy is~     safety and tolerable when administered to patients with locally advanced or metastatic~     bladder cancer and to gain preliminary data on whether patients may benefit from this~     combination.~   "
186247|NCT01126736|"~     The purpose of this study is to determine whether Eribulin Mesylate Administered in~     Combination with Pemetrexed is safe and tolerable and to gain a preliminary indication of~     clinical benefit when administered to Patients with Stage IIIB or IV Nonsquamous Non Small~     Cell Lung Cancer.~   "
186248|NCT01126723|"~     The aim of this study is determine the effects of Tai Chi exercise, as compared to an~     education-based control intervention, on cardiovascular and balance system function in older~     people at risk of developing frailty. We hypothesize that long-term Tai Chi training will~     improve specific nonlinear properties associated of cardiovascular and balance dynamics in~     this population.~   "
186249|NCT01126710|"~     The purpose of this study is to investigate the safety and efficacy of an optical device~     designed and developed for monitoring the intravenous infusion site for infiltration. The~     hypothesis is that the changes in optical signals measured near the infusion site using the~     optical device can be used to monitor intravenous infusion for infiltration.~   "
186250|NCT01126697|"~     The study will include 120 participants aged 8 and up with Duchenne, Becker, or autosomal~     recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies that have no~     clinical cardiac symptoms. Participants will be randomized to one of four arms: Arm 1 CoQ10~     alone, Arm 2 Lisinopril alone, Arm 3 CoQ10 and Lisinopril or Arm 4 No study medication.~     Randomization will be stratified by ambulatory status and corticosteroid use. The primary~     outcome for the study is the myocardial performance index (MPI), measured by standard Doppler~     echocardiography. The study will last 24 months with visits at Months 0.5,1.5, 6, 12, 18 and~     24.~      Following completion of the Clinical Trial of Coenzyme Q10 and Lisinopril, participants will~     be offered participation in a companion protocol: PITT1215 A Natural History Companion Study~     to PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies. The~     objective of this study is to evaluate the longitudinal natural history of DMD, BMD, and~     LGMD2I and to evaluate the effects of Coenzyme Q10 and/or Lisinopril on prevention of cardiac~     dysfunction in these disorders.This will be an 18-month longitudinal natural history study~     designed to accompany the Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular~     Dystrophies.~   "
186251|NCT01126684|"~     To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary~     albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond~     those on lipid profile. Glycemic parameters, novel cardiovascular risk factors and safety~     parameters will be also evaluated.~   "
186252|NCT01126671|"~     This double blind, randomized controlled trial compares two supplemental doses of vitamin D~     in health adolescents.~   "
186253|NCT01126658|"~     The purpose of this study is to discover a mathematic equation to express the intracranial~     pressure-volume (P-V) curve and a single indicator to reflect the status of the curve.~   "
186254|NCT01126645|"~     The purpose of this study is to evaluate Sorafenib and local microtherapy guided by Primovist~     enhanced MRI in patients with inoperable liver cancer (HCC).~      Methodology:~      Patients with a diagnosis of hepatocellular carcinoma will receive either:~        -  local ablation therapy of liver lesions by radiofrequency ablation followed by sorafenib~          or placebo (local ablation group), or~        -  radioembolization (SIRT) + sorafenib or sorafenib alone (palliative treatment group).~      In each study group, patients will be randomized to one of the two treatment arms following a~     pre-defined randomization plan. Randomization will be on a 1:1 basis in the local ablation~     group and on the basis of 10 (sorafenib only) : 11 (SIRT + sorafenib) in the palliative~     treatment group.~      Patients in the local ablation group will be followed at 2 months intervals for recurrence~     and overall survival, patients in the palliative treatment group will be followed for overall~     survival. Follow-up in each study group will end 24 months after inclusion of the last~     patient into the respective study group.~      The assignment of patients to the local ablation or palliative study group will be based on~     the ablative potential of RFA (local ablation if ≤4 tumors, each ≤5 cm in size). Diagnostic~     imaging will be used to guide this decision. The assignment to the local ablation or the~     palliative treatment group will be made by the local investigator.~      As a sub-study, all patients will undergo Primovist®-enhanced MRI in addition to~     contrast-enhanced CT before assignment to one treatment group. The goal of the sub-study is~     to assess the value of Primovist®-enhanced MRI to correctly stratify patients for a local~     ablation or palliative treatment strategy. Primovist®-enhanced MRI will be compared with~     contrast-enhanced multislice CT using a truth panel assessment as the standard of reference.~     In addition, Primovist-enhanced MRI and contrast-enhanced CT will be obtained during~     follow-up of patients in the local ablation group to assess its potential for detection of~     recurrence.~   "
186255|NCT01126632|"~     Observing the effects of an Olympus cap on the visibility and in adenoma detection during~     colonoscopy.~   "
186256|NCT01126619|"~     In recent years, biologics have changed the treatment of psoriasis, giving us additional~     therapeutic options that are potentially less toxic to the liver, kidneys, and bone marrow~     and are not teratogenic. Nevertheless, traditional systemic therapies continue to play an~     important role in the treatment of psoriasis in Turkey, even in patients who are requiring~     biologic treatments according to national recommendations. This study is designated to~     observe the effectiveness and safety of tumor necrosis factor inhibitors in patients with~     moderate to severe psoriasis.~   "
186257|NCT01126606|"~     Primary Objective:~      To evaluate the potential of hydratation and renewal of the mucosa, through corneometry~     measurement and individual questionnaire perception.~      Secondary Objective:~      To evaluate the safety in normal condition of use.~   "
186258|NCT01126593|"~     Subacromial pain catheters have been used with uncertain efficacy for many years after~     rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that~     postoperative subacromial continuous infusion bupivacaine catheters will provide no pain~     control benefits over placebo infusions or no catheter use.~   "
186259|NCT01126580|"~     The purpose of this study is to determine if LY2189265 is safe and effective in reducing~     glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2~     Diabetes.~   "
186260|NCT01126567|"~     The objective of this study is to determine the effects of cerebrospinal fluid sampling rate~     on biomarker levels of young, healthy volunteers.~   "
186261|NCT01126554|"~     Comparison of ICG liver testing with copeptin and SAPS II score as prognostic markers in~     critically ill patients.~   "
186262|NCT01126541|"~     This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera~     (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced~     an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies~     etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg~     intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a~     moderate or good response will be randomized to receive re-treatment with either 1 or 2~     additional infusions of 1000 mg IV MabThera. The anticipated time on study treatment is 2+~     years, and the target sample size is 100-500 individuals.~   "
186789|NCT01119664|"~     The purpose of this study is to find the safety of combination gene therapy and chemotherapy~     in patients with malignant pleural mesothelioma. Pleural catheter will be placed first, then~     pts will receive 2 doses of intrapleural vector followed by front line or second line~     chemotherapy 4-6 cycles every 21 days.~   "
186263|NCT01126528|"~     This study is a randomized placebo-controlled trial of oral weekly vitamin D3~     (cholecalciferol) supplementation during the third trimester of pregnancy among women in~     Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence~     that improving vitamin D status among pregnant women in Bangladesh will enhance the~     resistance of the infant offspring to infection.~      The aims of the study are to assess the effect of supplementation on 1) maternal and infant~     vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of~     neonatal immune function.~   "
186264|NCT01126515|"~     The purpose of this study is to evaluate Brain MRI (Magnetic Resonance Imaging), and Brain CT~     (Computed Tomography) Angiogram data in subjects who participate in the Hyperbaric Oxygen~     for Chronic Stable Brain Injury (HYBOBI) study. Including information from MRI and CT~     studies provide information about whether hyperbaric oxygen improves brain function in~     subjects who have had a brain injury. Subjects will complete MR and CT scans twice during the~     study. The first MR and CT will be performed prior to the first hyperbaric session of the~     HYBOBI study, and the second will be performed within two weeks following the last hyperbaric~     session.~   "
186265|NCT01126502|"~     This phase I trial is studying the side effects and the best dose of alvespimycin~     hydrochloride in treating patients with relapsed chronic lymphocytic leukemia (CLL), small~     lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL). Drugs used in~     chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing.~   "
186266|NCT01126476|"~     The purpose of this study is to determine the feasibility of using proton radiotherapy for~     reirradiation of recurrent malignancies.~   "
186267|NCT01126463|"~     This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol~     activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The~     new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the~     radioprotection constraints and hence the duration of the hospitalisation in a protected room~     from 8 to 1 day.~   "
186268|NCT01126450|"~     RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the~     tumor. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Giving lenalidomide together with~     cetuximab may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when~     given together with cetuximab in treating patients with metastatic colorectal cancer.~   "
186269|NCT01126437|"~     Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations~     have been limited to 4-week crossover studies. Therefore, prospective data from a trial of~     adequate size and duration is required to establish that compared to tiotropium HandiHaler®,~     tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior~     effects on exacerbations.~   "
186270|NCT01126424|"~     The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any~     potential effects on mental ability.~   "
186271|NCT01126411|"~     The purpose of this study is to investigate, if Immunoadsorption of autoantibodies with~     subsequent substitution of immunoglobulins is able to improve haemodynamics in patients with~     pulmonary hypertension.~   "
186272|NCT01126398|"~     This study is designed as a prediction trial. That is, our primary purpose is to develop a~     model that can be applied clinically as a user-friendly baseline questionnaire that is~     capable of predicting success or failure based on a patient's pre-surgical expectations~     of their final outcome. In the process, a secondary goal is to develop an outcomes measure.~   "
186273|NCT01126385|"~     A new mechanical device was developed in order to provide the surgeon with intraoperative~     information about the mechanical strength of the cancellous bone within the vertebral body.~     DensiProbe Spine is intended to be used in patients undergoing transpedicular stabilization~     of the thoracolumbar spine. The objective of the DensiProbe Spine pilot study is to~     investigate the handling and feasibility of the DensiProbe Spine measurement device.~   "
186274|NCT01126372|"~     Prematurely born infants with ductal-dependent congenital heart disease (CHD) are at~     increased risk to develop necrotizing enterocolitis (NEC). Abnormal left to right blood flow~     through a patent ductus arteriosus can cause intestinal ischemia and compromise the~     gastrointestinal tract as a barrier to infection. In some infants, bacterial translocation~     leads to NEC which may result in death, intestinal perforation, cholestasis and, at the very~     least, feeding problems. Predicting which infants with CHD will develop NEC will potentially~     decrease the severity of disease if interventions were started earlier.~      Near-infrared spectroscopy (NIRS) allows determination of regional oxygen saturation levels~     in tissues such as brain, kidney, and as recently reported, intestine. This study will test~     whether or not decreasing intestinal oxygen saturations can predict the development of NEC in~     this at risk population before the symptoms become severe. NIRS probes will be placed on the~     forehead, flank and abdomen of eligible infants and regional oxygen saturations will be~     recorded prospectively and continuously with the clinical care team blinded to the data. The~     development of NEC and significant feeding problems will then be correlated with the regional~     oxygen saturations to determine whether decreased intestinal oxygen saturations predicted~     early signs and symptoms of NEC.~      We anticipate generating pilot data in 30 infants who meet inclusion criteria. Support of~     this research will be provided partially by Somanetics, the manufacturer of the INVOS~     regional oxygen saturation monitors. They will, however, have no control over the data~     generated by this study.~   "
186275|NCT01126359|"~     The purpose of this prospective study is to compare pain levels and pain medication dose~     requirements in patients with topical negative pressure (TNP) dressings removed in a standard~     manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via~     injection retrograde up the suction tube into the foam prior to removal. Our null hypothesis~     is that there will be no difference in overall pain scores or medication requirements when~     patients receive a saline, control injection and pain medications, compared to when their~     dressings are changed with a lidocaine injection into the sponge, with pain medications. Our~     objective is to disprove this null hypothesis with statistical significance.~   "
186276|NCT01126346|"~     RATIONALE: An orientation and patient education program and telephone counseling may help~     improve the quality of life in patients with peritoneal surface malignancies.~      PURPOSE: This clinical trial studies quality of life and survivorship care in patients~     undergoing surgery and chemotherapy for peritoneal surface malignancies.~   "
186277|NCT01126333|"~     Allograft nephropathy is the most common cause of allograft failure following kidney~     transplantation. Among putative etiologies, cumulative exposure to calcineurin inhibitors may~     be one of the important progression factors.~      Spare the Nephron(STN) is a unique study. Patients were randomized to either continue~     center-specific Calcinerium Inhibitor (CNI) therapy or have CNI replaced with sirolimus~     within the first six months after transplantation. Approximately 305 patients were enrolled~     in the study. More than 230 patients finished 2 years of follow-up. There was better patient~     and graft survival in those converted to sirolimus. There was also a 10% improvement in the~     kidney function of those who were converted. In this cohort, we wish to explore the~     durability of this improvement.~   "
186278|NCT01126320|"~     Ventilator Associated Pneumonia (VAP) is a common complication experienced by mechanically~     ventilated patients and within the framework of Respiratory Intensive Care Units. The~     AnapnoGuard system, developed by Hospitech Respiration Ltd. is a ventilation guard system~     that includes a number of unique characteristics. This study was designed to test the~     frequency VAP in mechanically ventilated ICU patients using the AnapnoGuard System.~   "
186279|NCT01126307|"~     Epilepsy is one of the most common chronic neurological diseases, affecting 300,000~     Canadians. One in 3 epilepsy patients have refractory seizures meaning that all antiseizure~     drugs fail to control their seizures. This drug resistance in epilepsy may be related to the~     over expression of multidrug resistance proteins (MDR). Varapamil inhibits MDR. We propose to~     add verapamil/placebo to patients' anti epilepsy medication for 3 months. Patients who~     receive placebo will have verapamil added for 3 months after the completion of the~     double-blind treatment period. Seizure frequency/severity will be tracked. Blood samples for~     DNA will be collected. There will be 9 clinic visits over 32 weeks. ECG and echocardiogram~     will be done at baseline and repeated if necessary~   "
186280|NCT01126294|"~     Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or~     placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety~     will be assessed over the 24 hour period following surgery.~   "
186281|NCT01126281|"~     The aim of this study is to evaluate the effect and safety of Floseal in this preliminary~     prospective trial with patients undergoing acute laparoscopic cholecystectomy for acute~     cholecystitis~   "
186282|NCT01126268|"~     The purpose of this study is to document the clinical and bacteriological efficacy of~     retapamulin in the treatment of subjects with bacterial infections, including impetigo,~     folliculitis, and minor soft tissue infections including secondarily infected eczema presumed~     to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to~     98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound~     cultures will be collected, and then subjects will apply topical retapamulin twice daily for~     five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus~     aureus (MRSA) infection based on clinical presentation and physical exam, as well as~     bacteriological efficacy based on culture results. It is anticipated that approximately 75~     patients will be enrolled, with expectation that approximately 50 of these patients will have~     MRSA infections.~   "
186283|NCT01126255|"~     This is a randomized trial comparing progesterone with conventional clobetasol propionate in~     patients with vulvar lichen sclerosus.~   "
186284|NCT01126242|"~     The objective of this study is to compare tape versus semi rigid support versus lace up brace~     treatment for acute lateral ankle ligament injuries with regard to clinical outcome and cost~     effectiveness.~      There is a difference of 10 in functional outcome (Karlsson Score) between non-elastic~     adhesive taping and semi-rigid and lace-up ankle support, in favour of the last, for the~     treatment of acute lateral ankle ligament injury at 6 months follow-up.~   "
186285|NCT01126229|"~     The investigators aim to conduct a randomized placebo controlled pilot study to determine~     whether resveratrol, a dietary ingredient, supplementation is safe and improves memory and~     physical performance in older adults. Loss in memory and physical performance is a frequent~     complaint in older adults and a growing public health issue. Additionally, later adulthood is~     associated with a normative decline in both working and primary memory as well as domains~     including attention, speed of processing and executive function. Resveratrol is safely~     tolerated in pre-clinical models and in dose-escalation human studies. It also has~     demonstrated beneficial effects on memory and performance in pre-clinical models. Therefore,~     this study will take the next step in understanding the longer-term safety (3 months) and~     efficacy of resveratrol supplementation on age-related health conditions.~   "
186286|NCT01126216|"~     Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis~   "
186287|NCT01126203|"~     Multi-center, prospective, randomized, controlled clinical trial to compare selective laser~     trabeculoplasty (SLT) and Argon laser trabeculoplasty (ALT) in pseudoexfoliation glaucoma and~     ocular hypertension patients. IOP will be recorded, at baseline, 6 weeks, 6 months and 1 year~     after the laser procedure.~   "
186288|NCT01126190|"~     Determination of the effect of Neugranin on the duration and severity of severe neutropenia~     in subjects receiving doxorubicin in combination with docetaxel.~   "
186289|NCT01126177|"~     When people with asthma get respiratory virus such as a cold or flu it often increases asthma~     symptoms. The investigators will test the study medication to find out if it can prevent the~     virus spreading from the nose to the lungs.~      SNG001 contains Interferon-beta that occurs naturally in the body. In this study, SNG001 will~     be given by a nebuliser.~   "
186290|NCT01126164|"~     Parent and peer interventions to reduce student drinking~   "
186291|NCT01126151|"~     Examine the efficacy of parent interventions to prevent college student drinking in first~     year students.~   "
186292|NCT01126138|"~     It is a phase III trial to explore the efficacy and safety of vinorelbine plus capecitabine~     (NX) and docetaxel plus capecitabine (TX) as first line treatment followed by capecitabine~     alone till Progressive Disease(PD). We plan to enroll 200 pts for limited budget and the~     non-inferior trend of the two curves is anticipated.~   "
186293|NCT01126125|"~     In iodine-deficient countries or regions that have inadequate iodized salt distribution, the~     World Health Organization (WHO) recommends choosing one of two methods to improve iodine~     intakes in breastfeeding infants: 1) iodine supplement (400 mg as iodized oil; 1/year) to the~     breastfeeding mother, or 2) iodine supplement (100 mg as iodized oil; 1/year) directly to the~     infant. However, the relative efficacy of these two methods of providing iodine to the~     newborn has never been directly compared. Whether the first method of iodine supplementation~     to the breast feeding mother can significantly improve iodine supply and maintain normal~     thyroid function in her infant remains unclear. This study will directly compare these two~     strategies. The hypothesis is that the two strategies will be equally effective in providing~     iodine to the newborn.~   "
186294|NCT01126112|"~     The purpose of the study is to evaluate the efficacy and safety of first-line single-agent~     panitumumab in frail elderly patients with advanced Wild Type K-RAS colorectal cancer~   "
186295|NCT01126099|"~     A study of outpatient participants with Alzheimer's disease or a related dementia who have~     difficult behaviors that are upsetting for them or their caregivers. Prazosin is a medication~     that is commonly used to treat people with high blood pressure. Research with prazosin has~     shown that it may be effective in treating behavioral problems by reducing excess adrenalin~     effects in the brain.~   "
186296|NCT01126086|"~     Primary Objective:~      - To study effect of mild and moderate hepatic impairment on the pharmacokinetics of~     otamixaban.~      Secondary Objective:~      - To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate~     hepatic impairment and in matched subjects with normal hepatic function.~   "
186297|NCT01126073|"~     Primary objective:~      To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant~     (ERN/LRPT) compared to placebo added to statin therapy on endothelial dependant dilatation of~     the arterial wall assessed by brachial vasoreactivity in stable coronary heart disease (CHD)~     patients.~      Secondary objective:~      To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant~     (ERN/LRPT) compared to placebo added to statin therapy on serum lipids and the parameters of~     inflammation in stable coronary heart disease (CHD) patients.~      CHD-coronary heart disease ER-extended release~   "
186298|NCT01126060|"~     Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well.~     However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel~     is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus~     reducing op time and postoperative drain, which is important to minimize hospital stay. The~     investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted~     procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior~     compartment neck dissection.~   "
186299|NCT01126047|"~     The purpose of this study is to check the accuracy of a procedure called exhaled carbon~     monoxide (eCO) testing. Exhaled carbon monoxide is used by physicians to help assess~     breathing in people with conditions like asthma and emphysema. eCO may be used to correct~     another breathing test (called diffusing capacity, or DLCO). Blood collection is usually~     required to correct the DLCO, so validation of the eCO test may help avoid that blood~     collection.~   "
186300|NCT01126034|"~     The investigators hypothesized that:~      1) an intervention targeted at the prescribing physician would increase the rate of a~     metoclopramide discontinuation among patients prescribed the medication for questionable or~     unclear indications; and 2) the discontinuation would be durable.~   "
186301|NCT01126021|"~     The study plans to test the effectiveness of behavioral economics based incentives to promote~     the daily use of computer programs designed to improve memory and mental acuity. Subjects~     will be recruited from the Pittsburgh metropolitan area. The primary objective is to~     determine the impact of structured financial incentives on the number of computer-based~     cognitive exercises completed during a 3 month intervention period.~   "
186302|NCT01126008|"~     This phase II trial is evaluating the efficacy of concurrent chemoradiation therapy with~     weekly docetaxel and cisplatin combination regimen.~   "
186303|NCT01125995|"~     The purpose of the study is to evaluate the efficacy and toxicity of different timing of~     concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.~   "
186304|NCT01125982|"~     The purpose of this study is to establish validated outcome measures for Postoperative~     Fatigue and Postoperative nausea, and to compare clinical impact of postanaesthetic symptoms~     during first week after Propofol or Desflurane based anaesthesia.~   "
186305|NCT01125969|"~     In recent years, social networks have garnered attention in both academic journals and the~     lay press because of strong associations demonstrated in retrospective studies between social~     networks and incidence of major health problems such as obesity and smoking. Financial~     incentives have also been demonstrated to improve health behaviors in obesity, smoking, and~     medication adherence. We propose to conduct a randomized controlled trial among a~     predominantly African American population with persistently poor diabetes mellitus (DM)~     control to examine whether two novel interventions, lottery based financial incentives and~     telephone based one-on-one peer mentoring (the 'buddy system'), can significantly ameliorate~     disparities in poor DM control.~      The intervention is based on epidemiologic evidence, randomized controlled trials, and pilot~     studies demonstrating: 1) Lottery based financial incentives are a powerful motivator of~     behavior change; 2) One-on-one peer mentoring is a flexible, cost-efficient means of~     increasing DM specific social support and may be particularly salient in minority~     communities; and 3) Matching patients with poorly controlled DM with a similar individual~     from their community who has gained control of their DM draws on existing community assets in~     creating an inherently culturally competent intervention. DM patients with poor DM control~     will be randomized to 1 of 4 arms: usual care; telephone based one-on-one peer mentoring;~     lottery based financial incentives; and peer mentoring plus financial incentives.~      The Specific Aims are to test: 1) The effectiveness of telephone based one-on-one peer~     mentoring in improving glycemic control relative to usual care; 2) The effectiveness of~     lottery based financial incentives in improving glycemic control relative to usual care; 3)~     The effectiveness of combining peer mentoring and financial incentives relative to control;~     and 4) The relative cost effectiveness of all four approaches. In exploratory analyses, we~     will examine whether African American patients enrolled in intervention arms have greater~     improvement in glycemic control than white patients, whether intervention group patients~     experience greater improvements in blood pressure (BP) and lipid control, and whether peer~     mentors experience improvements in their own health. We will pair mentors with mentees based~     on race, gender, age, and disease severity. The active intervention will be run for a 6-month~     time period, with participants followed for an additional 6 months to determine if effects~     persist post intervention.~      The proposed interventions address multiple barriers to effective disease management common~     among patients with DM. If effective, these interventions could provide important models for~     improving glycemic control in general and, in particular, for addressing racial disparities~     in DM outcomes.~   "
186318|NCT01125800|"~     Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and~     pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent~     or refractory medulloblastoma, or other tumors potentially dependent on Hedgehog signaling~     pathway.~      Phase II study is to assess preliminary efficacy in both adult and pediatric patients with~     recurrent or refractory MB.~   "
186306|NCT01125956|"~     The specific aims of this study are to test whether in a cohort of low-income minority~     veterans with poor diabetes mellitus (DM) control:~        1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).~        2. Financial incentives are an effective means of reducing HbA1c. This is a randomized~          controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled~          diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial~          incentives without peers. Ultimately, contingent on the success of this intervention,~          the researchers plan to apply for funding for a large scale intervention employing both~          peer counseling and incentives to improve DM control in low income and minority patients~          who are at high risk for premature morbidity and mortality.~   "
186307|NCT01125943|"~     The introduction of angiogenesis inhibitors has remarkably improved treatment of patients~     with several types of cancer. One of the most reported side effects of angiogenesis~     inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody~     against vascular endothelial growth factor, hypertension had an overall incidence up to 32%.~     The increase in blood pressure occurs early in treatment. The etiology of hypertension caused~     by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this~     side effect is essential for optimal treatment with this class of drugs.~      The primary objective is to explore the effect of bevacizumab infusion on~     endothelium-dependent vasodilation of forearm resistance arteries.~   "
186308|NCT01125930|"~     Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with~     frequent flushing, topical sensitivity and prominent blood vessels. We think that long term~     damage to skin from the sun (photodamage) may play a role in causing this type of rosacea.~     Tretinoin is a topical medication that is known to improve photodamage. We want to find out~     if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve~     erythematotelangiectatic rosacea (ETR).~   "
186309|NCT01125917|"~     The purpose of the extension phase is to evaluate the long-term safety and tolerability of~     buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h~     and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on~     adequate pain relief and tolerability.~   "
186310|NCT01125904|"~     An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being~     tested for its' palatability in adults.~   "
186311|NCT01125891|"~     Treatment of cancer is often more effective when two or more drugs are used together. For~     example, when gemcitabine, an approved drug, and ON 01910.Na, a new investigational~     anti-cancer drug, are used together to treat cancer cells in laboratory animals, there is~     more inhibition of the growth of the cancer cells compared to either drug used by itself.~     These results offer promise that gemcitabine and ON 01910.Na could be used to treat cancer in~     patients. However, before studies that seek to find out if gemcitabine and ON 01910.Na is an~     effective combination in patients can be done, doctors must first know what is largest, safe~     dose of ON 01910.Na that can be used in combination with gemcitabine. This study is designed~     to answer that question.~   "
186312|NCT01125878|"~     Investigators are interested in learning how appetite responds to certain types of starch and~     fiber mixtures. In this research study, subjects will be asked to consume cookie bars~     containing different types of starch and fiber mixtures, then describe their feelings of~     hunger, fullness and desire to eat for the 3 hour study period. Subjects will be asked to do~     this on four separate occasions. Following the 3 hour study period, a deli-style lunch will~     be served. Investigators want to see how appetite responds to these four different starch and~     fiber mixtures.~   "
186313|NCT01125865|"~     The overall median survival of nonresectable malignant hilar obstruction in most series has~     been less than 6 months. Most patients with malignant hilar obstruction present with advanced~     disease, making palliative endoscopic drainage the principal therapeutic option. However, the~     optimal endoscopic management strategy is contentious. Almost all of the published data~     comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common~     bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have~     favored metallic stents when compared with plastic stents in patients with distal malignant~     obstruction expected to live at least 3 to 6 months.~      There are few comparative study as to whether self-expanding metallic or plastic stent,~     especially DLS (double layer plastic stent) are preferable in the technical success, stent~     patency, and cost-effectiveness for palliating malignant hilar obstruction.~      The study was designed to compare the the technical success, stent patency, and~     cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar~     obstruction.~   "
186314|NCT01125852|"~     Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment,~     there is a high risk of rebleeding and high mortality. In this study the investigators~     examine whether combined endoscopic haemostasis and angiographic embolization resolves in a~     better outcome than the traditional use of endoscopic haemostasis alone. The study is a~     randomised controlled trail.~   "
186315|NCT01125839|"~     Vertebral osteomyelitis is a uncommon disease that can lead to neurologic deficits if not~     diagnosed in time. The etiologies of vertebral osteomyelitis include pyogenic bacteria, M.~     tuberculosis, Brucella species, and fungus. The aim of this study is to describe the clinical~     features and microbiological/radiological characteristics of patients with vertebral~     osteomyelitis, and investigate the useful tips for the differential diagnosis of vertebral~     osteomyelitis.~   "
186316|NCT01125826|"~     The purpose of this study is to culture primary human brain tumor cells with the specific~     aims of:~        1. Develop primary cultures from human brain tumor surgical specimens~        2. Determine the genetic and molecular fingerprints of brain tumors that may have~          prognostic significance~        3. Delineate the mechanisms underlying oncogenesis of brain tumors.~        4. Perform in vitro assays with brain tumor derived primary cultures to assess the efficacy~          of novel therapeutic agents.~   "
186317|NCT01125813|"~     This study will determine the efficacy of human-cl rhFVIII in previously treated patients~     with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in~     surgical prophylaxis.~   "
186367|NCT01125163|"~     In preterm infants with birth weights less than 1500 grams, does iron supplementation with~     2mg/kg/day in addition to feeding with routine iron-fortified milk (formula or fortified~     mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks~     adjusted post-menstrual age (or at discharge if sooner)?~   "
186319|NCT01125787|"~     Investigational Drug:~      Ofatumumab (Azerra)~      Route of Administration:~      Intravenous (IV)~      Hypothesis:~      This study is designed to assess the toxicity and overall response rate. Ofatumumab is a~     fully human monoclonal antibody (A type of protein made in the laboratory that can bind to~     substances in the body, including tumor cells) that shows promising activity in the treatment~     of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA~     approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given~     alone.~      Participation:~      Approximately 38 previously untreated CLL subjects will participate in this study over two~     years.~      Treatment Plan:~      A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV~     300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by~     bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be~     administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only~     patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will~     be given on day 1 only.~      Follow-up:~      Patients will be followed monthly for six months, then every three months for five years then~     annually thereafter.~   "
186320|NCT01125774|"~     This is a multicenter study to test the hypothesis that telcagepant is superior to placebo in~     preventing perimenstrual migraines as measured by mean monthly headaches during the entire~     treatment period. This study will also evaluate the safety and tolerability of telcagepant~     for female migraine participants.~   "
186321|NCT01125761|"~     Considering the pathogenesis of several allergic skin diseases to be investigated in this~     study as well as the pharmacodynamic mechanisms of the association of dexamethasone and~     clemastine fumarate, it is believed that the components of topical medication may act~     synergistically in the reduction of signs and symptoms of the diseases in question. Therefore~     it is expected that the association promotes results significantly superior to dexamethasone~     alone.~   "
186322|NCT01125748|"~     This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants~     who completed the EXCELS study (NCT00252135) and had received long-term treatment with~     Xolair. In addition, participants who did not participate in the EXCELS study but received~     long-term (~5 years) treatment with Xolair were allowed to enter the study.~   "
186323|NCT01125735|"~     The purpose of this study is to evaluate the effectiveness of MIST Therapy in combination~     with standard of care (SOC) compared to SOC alone on reducing the bacteria in your wound and~     preparing the wound bed for surgical closure in patients that have chronic, non-healing~     wounds.~      The MIST Therapy System delivers therapeutic ultrasound to the wound bed without direct~     contact. Saline solution is converted into fine particles and released towards the wound by~     sound pressure waves to remove dead or damaged tissue. The MIST Therapy System is currently~     the only FDA cleared non-contact ultrasound device to promote wound healing.~      Standard of care procedures include surgical debridement of the wound in the operating room~     to remove all infected, dead tissue and bone.~      This research is being done because the investigators do not know which of these~     commonly-used treatments is better, and because the investigators would like to evaluate the~     bacteria that is present in the wound.~   "
186324|NCT01125722|"~     The purpose of this study is to determine whether the non-invasive neurostimulation patch is~     effective in the treatment of urgency, frequency and urge (urinary) incontinence.~   "
186325|NCT01125709|"~     The aim of the proposed research is to compare two commonly used pediatric strength testing~     measures: handheld myometry (HHM) and CINRG Quantitative Measurement System (CQMS), with the~     goal of identifying a sensitive and valid tool for measuring muscle strength in children with~     DMD. The data obtained from this study will be used to make recommendations for strength~     measurement endpoints in prospective muscular dystrophy trials and provide more reliable and~     accurate recommendations in the clinic for strength assessment. This study will be performed~     at six participating sites in the Cooperative International Neuromuscular Research Group~     (CINRG).~   "
186326|NCT01125696|"~     The purpose of this study is to compare a regimen of tenofovir/lamivudine/lopinavir-ritonavir~     to the WHO-recommended and locally practiced standard of care regimen consisting of~     zidovudine/lamivudine/lopinavir-ritonavir during the second and third trimesters of pregnancy~     in HIV and HBV co-infected women. This is a phase II study evaluating the safety of the test~     regimen in pregnant women and their newborns. While the study is not powered to examine~     efficacy, preliminary estimates of transmission of HIV and HBV to the infants and of the rate~     of resistance development will be obtained.~   "
186327|NCT01125683|"~     The purpose of this study is to evaluate whether treatment with single and multiple oral~     doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and~     Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9~     weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days~     each.~   "
186328|NCT01125670|"~     This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make~     adult subjects.~   "
186329|NCT01125657|"~     This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2~     crossover method.~   "
186330|NCT01125644|"~     Recruitment of at least 10 adult patients (men and women) among individuals affected and~     admitted to the hospitals identified for the clinical study. All patients shall be between 18~     and 75 years of age, with confirmed diagnosis of cryptococcosis or aspergillosis . During~     therapy (14 days) and examination (28 days), the patients will be subject to 7 doctor's~     visits (day 1,3,7,10,14,21, and 28).~   "
186331|NCT01125631|"~     The purpose of the study is to examine the safety and tolerability of a multiple dose of~     PF-04360365 administered over approximately 10 minutes in Japanese patients with~     mild-to-moderate Alzheimer's disease and to characterize the pharmacokinetics of PF-04360365~     following administration of multiple doses in Japanese patients with mild-to-moderate~     Alzheimer's disease.~   "
186368|NCT01125150|"~     Acanthosis Nigricans is skin disease that associated with hyperinsulinemia. Clinical is~     velvety hyperpigmented plaques on neck, axilla, groin. If hyperinsulinemia is improved by~     treated with oral metformin and/ or diet control, acanthosis nigricans would be improved as~     well. Hyperpigmented plaques will be changed. We assess objective measurement by using~     spectroscopic and colorimetric analysis.~   "
186790|NCT01119651|"~     The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a~     photoallergic reaction when exposed to UV and VIS light on skin of healthy volunteers.~   "
186332|NCT01125618|"~     The Millennium Villages Project involves the coordinated and simultaneous delivery of a~     package of proven interventions in health, agriculture, infrastructure and education. The~     project works in partnership with governments in 10 African countries in areas where progress~     towards achieving the Millennium Development Goals has been insufficient.~      The Project evaluation will test the following hypotheses:~        1. That after 5 years of operation, villages exposed to the MVP intervention will have a~          lower rate of under-5 mortality and parallel gains in MDG-related secondary outcomes~          when compared to similar villages not receiving the intervention.~        2. That the coordinated delivery a multi-sector package of health and development~          interventions implemented through a broad-based local partnership is feasible in a~          diversity of sub-Saharan African contexts, and;~        3. The intervention package can be delivered at a scalable cost of $40 per person per year~          in the health sector and $110 per person per year in total~   "
186333|NCT01125605|"~     The purpose of this observational study is to give an overview of the use of PASCONAL~     NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to~     nervousness.~   "
186334|NCT01125592|"~     Makers of ionic foot baths claim that their machines can eliminate heavy metals from the~     body. Researchers at the Canadian College of Naturopathic Medicine are evaluating the ability~     of an ionic foot bath to help eliminate heavy metals from the body by rigorously testing the~     machine under controlled conditions. The machine will first be tested without feet under~     normal operating conditions and again after operation under normal conditions with foot~     immersion.~   "
186335|NCT01125579|"~     Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of~     nervous restlessness in children aged 6 to 12.~      Each patient is treated with NPB. No placebo group is established. Course and severity of~     symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a~     Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist~     (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's~     discretion. The planned treatment and observation period is 2 - 4 weeks.~   "
186336|NCT01125566|"~     To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v.~     chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who~     failed one prior trastuzumab (Herceptin®) treatment~   "
186337|NCT01125553|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in~     healthy subjects.~   "
186338|NCT01125540|"~     Patients with seasonal allergic conjunctivitis are normally advised to avoid contact lens~     wear when they are having symptoms. However, modern soft contact lenses which are disposed of~     daily offer the potential to protect and lubricate the ocular surface. This study examines~     this possible effect.~   "
186339|NCT01125527|"~     This study will evaluate the safety and immunogenicity of single dose of two commercially~     available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59~     months of age.~   "
186340|NCT01125514|"~     This study assessed the interaction between single and multiple doses of aliskiren (150 mg~     and 300 mg) and furosemide (60 mg) in patients with heart failure.~   "
186341|NCT01125501|"~     Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic~     syndrome and proteomics will identify protein profiles that correlate with markers or/changes~     in oxidative stress.~   "
186342|NCT01125488|"~     The recurrence rates of endometriosis reported in women 5 years after therapy with~     gonadotropin releasing hormone (GnRH) agonist were 74% for severe disease . No strategies to~     prevent the recurrence of endometriosis have been uniformly successful. Local progesterone~     treatment of endometriosis-associated dysmenorrhea with a levonorgestrel-releasing~     intrauterine system (LNG-IUS) for 12 months has resulted in a significant reduction in~     dysmenorrhea, pelvic pain and dyspareunia; a high degree of patient satisfaction; and a~     significant reduction in the volume of rectovaginal endometriotic nodules. LNG-IUS may become~     a more important option if a long-term medical suppression of endometriosis.~      Based on literature review, I hypothesized that maintenance therapy of LNG-IUS in conjunction~     with the GnRH agonist could lower the recurrence rates endometriosis after conservative~     surgery. We try to answer the question whether maintenance therapy of LNG-IUS in conjunction~     with the GnRH agonist could lower the recurrence rates and thus extend the symptom-free~     interval (menorrhagia and dysmenorrhea) as compared to GnRH agonist alone after conservative~     surgery in severe endometriosis cases.~   "
186343|NCT01125475|"~     The primary objective is to determine adherence to Rebif® New Formulation administered by~     RebiSmart during 12 weeks of therapy in patients with RRMS.~   "
186344|NCT01125462|"~     The development of recombinant DNA technology, culminated in the introduction of the first~     recombinant human follicle stimulating hormone (r hFSH), Gonal-f, which further developed to~     become Gonal-f Filled-by-Mass (FbM) pen has been used in the fertility treatment since many~     years. It has been found that subjects using the pen found it less stressful, easier to use~     and more convenient than a conventional syringe and would recommend the prefilled pen to~     another woman considering gonadotropin treatment. However, the use of the Gonal-f (FbM) pen~     between Serbian subjects is on a very low level though the Gonal f vials with the 75 IU of~     follitropin alfa have been present in Serbian market since 2003. On the contrary from the~     clinical practice in European countries, Serbian subjects usually receive daily dose of~     injectable gonadotropins at the IVF clinics or by partner/family member.~      This open-label, multicentric, observational non-interventional study is designed with the~     aim to know the reason of Serbian subjects not injecting themselves with Gonal f and the~     quality of life (QoL) of Serbian women/couples with the infertility problem.~   "
186345|NCT01125449|"~     The study is designed to determine if high doses of intravenous ascorbic acid (vitamin C) can~     be effective in managing solid tumor diseases. Secondary goals are determination of any~     palliative effects and improvement of quality of life of patients.~   "
186346|NCT01125436|"~     The purpose of this study is to determine if vitamin D will improve physical performance in~     older adults with heart failure.~   "
186391|NCT01124851|"~     The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652~     given once daily to people with excessive daytime sleepiness. Subjects will be randomized to~     either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.~   "
186347|NCT01125423|"~     The purpose of this study is to examine the characteristics of the nerves and the small veins~     in the skin of people with fibromyalgia. This information will then be used to identify~     possible processes in the skin that may help explain why some people feel pain relief with~     the study drug (milnacipran) and others do not. The investigators expect to learn more about~     the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients.~     The investigators hypotheses are:~        1. The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical~          and/or morphological pathology among the sensory innervation.~        2. Fibromyalgia patients may have different sites of innervation.~        3. Milnacipran may have a therapeutic effect on some fibromyalgia patients.~        4. Abnormalities in fibromyalgia patients may predict the likelihood of a good response to~          milnacipran.~   "
186348|NCT01125410|"~     The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg~     dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to~     clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.~   "
186349|NCT01125397|"~     Obesity is an ever increasing public health problem in this country. Bariatric surgery is~     currently the most effective treatment for morbid obesity and two hundred thousand surgeries~     are performed in the United States each year. Unfortunately, despite anatomically successful~     surgery, it is estimated that at most surgical centers about 30 percent of patients will not~     achieve significant weight loss following surgery. It has been proposed that participation in~     preoperative behavior therapy can enhance postoperative outcomes, although empirical evidence~     for this premise is lacking. The current study is a pilot project designed to conduct a~     prospective randomized trial to examine the impact of participation in a 12-week standardized~     preoperative behavioral weight management program on percentage of excess weight loss and~     psychosocial and medical outcomes at six months after roux-en-Y gastric bypass surgery. The~     cost of bariatric surgery is not covered by this study and only patients local to the~     Rochester, Minnesota area are eligible to participate.~      It is hypothesized that patients who complete the 12-week behavioral program will experience~     greater weight loss and improved psychosocial and medical outcomes compared to controls.~   "
186350|NCT01125384|"~     Throat swabbing is an important instrument in the diagnosis of strep pharyngitis and~     sometimes the main argument for antibiotic treatment. There is no firm knowledge about an~     appropriate method of the swabbing for receiving maximal sensitivity. We hypothesize that~     accurate swabbing from the pus will increase the sensitivity of the swabbing as compared to~     free swabbing. In order to check this hypothesis we will compare two swabs from the same~     throat. One that will be taken by a physician specifically from the pass and the second will~     be taken by a nurse as she used to do it. An increase of 10% of positive results will be~     accepted as a significant advantage.~   "
186351|NCT01125371|"~     African American (AA) women are disproportionately affected by HIV/AIDs. The major risk~     factor for HIV acquisition among AA women is high-risk heterosexual sex, including~     unprotected vaginal and anal sex, and sex with a high-risk partner. Hazardous alcohol use has~     been associated with high risk sexual behaviors and prevalent gonorrhea among women attending~     an urban STI clinic, both of which increase a woman's vulnerability to HIV acquisition and~     transmission. This application proposes a randomized controlled trial (RCT) of a culturally~     tailored computer-directed brief alcohol intervention (CBI) enhanced with cell-phone booster~     calls using interactive voice response technology (IVR) and text messages among HIV-infected~     and at-risk AA women attending an urban STI Clinic. Hazardous drinking AA women (N=450)~     presenting with STI complaints will be randomized to one of three arms: 1) usual clinical~     care, 2) clinic-based, CBI, or 3) clinic-based, CBI + 3 booster calls using IVR and text~     messages. The CBI, an evidence-based based method for behavior change, will use principles of~     motivational interviewing, to counsel on: 1) alcohol use and 2) associated HIV/STI risk~     behaviors. Primary outcomes, measured at 3, 6, and 12 month intervals, include~     alcohol-related risk behaviors (number of binge drinking episodes, drinking days/week, and~     drinks per occasion), sexual risk behaviors (number of partners, episodes of unprotected~     vaginal/anal sex, episodes of sex while high), and occurrence of HIV/STI biomarkers. Prior to~     implementing the RCT, the CBI and IVR software messages will be revised to: 1) include the~     association between hazardous alcohol use and risky sexual behaviors, and 2) ensure their~     relevance and acceptability using quantitative/qualitative feedback from a sample of AA women~     attending a Baltimore City STI clinic. The proposed research focuses on a particularly~     vulnerable population of urban HIV at-risk and HIV-infected AA women seeking treatment in a~     public STI clinic and examines two novel BI intervention delivery strategies specifically~     tailored to be culturally/socially relevant to this minority population. If the~     intervention(s) prove to be effective, study findings will offer real life specialty care~     clinics a screening and intervention package that is practical, low cost, and easy to~     implement.~   "
186352|NCT01125358|"~     This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as~     assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of~     efficacy, safety, and tolerability.~   "
186353|NCT01125345|"~     The purpose of the study was to compare the postoperative PCO results of the single-piece~     hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in~     patients undergoing bilateral cataract surgery.~   "
186354|NCT01125332|"~     The purpose of this work is to estimate the efficiency in terms of pain of the application of~     a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in~     naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.~   "
186355|NCT01125319|"~     Hemophagocytic lymphohisticytosis (HLH) is a rare and severe disease of genetic origin in~     children (familial-HLH, F-HLH) or affecting adults secondary to infections, hematologic~     malignancies or auto-immune diseases (secondary_HLH, S-HLH). F-HLH are due to genetic~     mutations affecting the genes of perforin or proteins involved in its secretion, resulting in~     the complete loss of lymphocyte cytotoxicity without affecting lymphocyte number. In S-HLH,~     the investigators have observed a severe NK cell lymphopenia and a transient loss of~     cytotoxicity of unknown mechanism. In this study, the investigators will dissect macrophage~     activation mechanisms as well as NK cytotoxicity inability in adults patients suffering of~     S-HLH.~      Macrophage activation could result from the loss of the retro-control normally exerted by NK~     cells, thus the investigators will analyze reciprocal interactions of macrophages and NK~     cells during the acute phase and after recovery of S-HLH.~   "
186356|NCT01125306|"~     Xal-Ease is a novel Pfizer-Pharmacia device aimed to significantly facilitate the~     Xalatan/Xalacom instillation and to avoid loss of Xalatan/Xalacom eye drops due to incorrect~     instillation.~      Patients on Xalatan/Xalacom who have consumed more than one bottle per month within a year~     according to consumption data drawn from the Clalit Health Services database, will use the~     Xal-Ease device for a year. The device is expected to reduce consumption of bottles and~     result in saving money for both patients and medical care providers.~   "
186392|NCT01124838|"~     A study comparing the safety and efficacy of adalimumab compared with. placebo in adults with~     inactive non-infectious intermediate uveitis, posterior uveitis, or panuveitis.~   "
186357|NCT01125293|"~     The purpose of this research study is to test the safety of the combination of everolimus,~     rituximab and bortezomib. Everolimus is a drug that works by preventing cells in your body~     from growing and dividing. Information from basic and other clinical research suggests that~     everolimus may also inhibit tumor growth in people with relapsed or refractory lymphoma. The~     FDA has approved everolimus for the treatment of multiple myeloma, a cancer that is closely~     related to Waldenstrom's Macroglobulinemia. Rituximab is approved by the FDA for the~     treatment of non-Hodgkin's lymphoma, which included Waldenstrom's Macroglobulinemia.~      Funding Source - FDA OOPD~   "
186358|NCT01125280|"~     The purpose of this study is to apply and validate a clinicoradiological score for the~     prediction of severity of strangulated small bowel occlusion (SBO). This score was elaborated~     by analyzing clinical, biological and radiological parameters of patients admitted in an~     emergency center for acute strangulated SBO. Two clinical, two biological and two~     radiological parameters were shown to significantly predict the surgical outcome of SBO~     patients.~      Since any delay in the management of SBO may result in devastating consequences, a score~     predicting the severity of the SBO episode is an essential tool for helping in the management~     of SBO patients. A prospective multicenter validation of the score is mandatory for its~     extended use.~   "
186359|NCT01125267|"~     The project evaluates a culturally adapted, family-based intervention designed to promote~     treatment adherence among Mexican-Americans with schizophrenia using a randomized, controlled~     design in a public mental health setting. Mexican-American patients with schizophrenia and~     their families were randomly assigned to either: 1) one year of multi- family groups that~     emphasize the importance of attitudes towards adherence, subjective norms, and self-perceived~     and actual adherence skills in maintaining adherence, added to ongoing customary outpatient~     care; 2) standard multi-family groups without an emphasis on medication adherence, added to~     customary outpatient care; or 3) customary outpatient care only (monthly pharmacotherapy~     sessions and additional services as clinically needed). The study hypotheses are that~     subjects assigned to the adapted multi-family group would have better medication adherence,~     less psychiatric symptoms and fewer psychiatric hospitalizations throughout the course of the~     study (one year of treatment and one year of follow up) compared to the comparison~     conditions.~   "
186360|NCT01125254|"~     This study aims to investigate the use of amlodipine, a drug that blocks the uptake of~     calcium into cells, in the prevention and treatment of iron overload in patients with~     thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and~     other organs, blocking these channels might help to prevent the accumulation of iron in these~     tissues. The study will follow 10 patients with thalassemia major: 5 will openly receive~     amlodipine and 5 will serve as controls, not receiving any additional drugs. Patients will be~     monitored through one year with an additional year of follow up after the group using~     amlodipine stops its use. Monitoring will occur through the measurement of blood ferritin as~     well as live and heart T2* by MRI.~   "
186361|NCT01125241|"~     The main purpose of this study is to determine the effects of add-on therapy of wuling~     capsule on depressive symptoms in patients with comorbidity of epilepsy and depression, to~     evaluate its influences on the frequency and severity of seizures, and to observe its effects~     on patients' sleeping condition, quality of life.~   "
186362|NCT01125228|"~     This study will compare the effectiveness of zidovudine (AZT) alone vs. zidovudine plus~     interferon (IFN) vs. interferon alone in reducing HIV viral load, lessening immune system~     deterioration, and increasing the time to development of the first opportunistic infection in~     HIV-infected patients.~      HIV-infected persons 18 years of age and older with a T4 lymphocyte count of 500/mm3 or more~     and no current opportunistic infections may be eligible for this study. Candidates will be~     screened with a medical history, physical examination, blood tests, chest X-ray,~     electrocardiogram, urinalysis, and, for patients with Kaposi s sarcoma lesions, measurement,~     photographs, and biopsy of lesions.~      Patients will be assigned to receive treatment with either zidovudine alone, zidovudine plus~     interferon or interferon alone. They will continue treatment until one of the following~     occurs:~        -  Unacceptable side effects, despite dose modifications~        -  Development of an opportunistic infection~        -  Decrease in CD4 count by 20 percent or to an absolute count of less than 200/mm3~        -  Rapid progression of Kaposi s sarcoma lesions, requiring alternative therapy~        -  A decision is made to terminate the study~      Patients will be followed long term for viral load, immune function, development of~     opportunistic infections, disease progression, and survival.~   "
186363|NCT01125215|"~     The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin~     nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.~   "
186364|NCT01125202|"~     The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis~     patients, a behavioral intervention to reduce dietary sodium intake. The investigators will~     assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and~     health-related quality of life. The primary study hypotheses are that participants will gain~     less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced~     consumption of dietary sodium.~   "
186365|NCT01125189|"~     To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated~     interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid~     virologic response rates at least 35% greater than those with placebo.~   "
186366|NCT01125176|"~     Our hypothesis is that treatment of CLL with an alternating daily dosing schedule of~     thalidomide and lenalidomide may result in better tolerability by decreasing each agent's~     individual toxicities, while preserving efficacy, and therefore lead to a longer duration of~     therapy and improved responses. Additionally, the combination of the 2 agents may have~     additive or synergistic effects therapeutically.~      In Cycle -1, odd numbered patients will receive oral thalidomide daily days 1-14 followed by~     no treatment on days 15-28. Even numbered patients will receive oral lenalidomide daily on~     days 1-14 and then no treatment on days 15-28. Starting with cycle 1, patients will alternate~     daily thalidomide (every odd day) with daily lenalidomide (every even day) for days 1-28.~     Rituximab will be given on days 1, 8, 15, and 22 starting with Cycle 1, and then again every~     6th cycle thereafter (cycles 7, 13, 19, etc.)~   "
186393|NCT01124825|"~     The purpose of this study is to determine whether two new airway devices used during~     anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both~     work well in thin patients, but have not been tested in obese patients.~   "
186369|NCT01125137|"~     Purpose:~      To compare the levels of matrix metalloproteinase-1 (MMP-1), MMP-8, MMP-13 and tissue~     inhibitor of metalloproteinases (TIMPs) in keloid skin tissue with normal skin in the same~     patient and with normal discarded skin tissue (control). The investigators aim to correlate~     between levels of MMPs in patients with keloid scarring in comparison with normal and~     discarded tissue.~   "
186370|NCT01125124|"~     The primary purpose of this study is to determinate the degree of chest pain on patients with~     malignant pleural effusion submitted to pleurodesis with silver nitrate in three different~     dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). Our secondary purpose is to~     evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for~     pleurodesis in the aforementioned dosages/concentrations.~   "
186371|NCT01125111|"~     The clinical study of making the evidence with application of Da vinci-Robot assisted low~     anterior resection in rectal cancer~   "
186372|NCT01125098|"~     Exacerbations of chronic obstructive pulmonary disease (COPD) are the first cause of~     admission to Pulmonary Department in Italy and worldwide. Guidelines recommend treating most~     patients hospitalized for exacerbations of COPD with antibiotics, even if the role of~     bacterial infection is often uncertain and the effect of antibiotics poor. The recommendation~     to use antibiotics is guided by clinical signs and symptoms that have an insufficient~     diagnostic accuracy, whereas serum biomarkers as procalcitonin (PRO-CT) may guide the~     selection of COPD patients who need antibiotic treatment. The main aim of the study is to~     investigate whether antibiotics can be safely stopped after 3 days or continued for 10 days~     according to a PRO-CT-guided algorithm in patients hospitalized for exacerbations of COPD for~     whom guidelines recommend 3-10 days antibiotic treatment based on presence of increased~     dyspnoea, sputum and purulence. The study is designed to assess the non inferiority of the~     PRO-CT guided plan as compared to the standard guideline recommended plan. The PRO-CT guided~     withholding of antibiotics is viewed as an experimental intervention associated with less~     antibiotic-associated complications, eg antibiotic resistance and drug-related side-effect~     and lower costs. The proposed study is a prospective, randomised controlled, single-blinded~     intervention trial comparing the standard with a PRO-CT guided antibiotic treatment plan.~     Patients will be recruited from the Pulmonary Department of 18 University or City Hospitals~     in Italy, starting October 2006 and continuing until December 2010. Results expected by end~     of 2011. The 100 patients randomised to the standard non PRO-CT guided antibiotic treatment~     plan will continue antibiotics for 10 days, whereas the 100 patients randomised to the PRO-CT~     guided antibiotic treatment plan will continue for 10 days or stop antibiotics on day 3~     depending on PRO-CT levels measured at admission, day 1 and day 2. Serum PRO-CT will be~     measured in a central laboratory. Patients will be examined at admission, discharge, 10 days,~     1, 3 and 6 months. A telephone interview will be obtained at 2, 4 and 5 months. The primary~     outcome of the study will be the rate of exacerbations. Secondary outcomes will be hospital~     readmission, admission to ICU, change in FEV1, duration of hospitalization, and death. The~     sample size was estimated according to the primary outcome of the study.~   "
186373|NCT01125085|"~     The aim of this Proof of Concept study is to determine the therapeutic potential of the~     L19SIP antibody, labeled with the radionuclide 131I in combination with external beam~     radiation, for the treatment of patients with multiple brain metastases following the~     promising results with this agent in previous clinical studies.~      The L19SIP antibody is a fully human antibody, capable of preferential localization around~     tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a~     rare event in the adult (exception made for the female reproductive cycle), but is a~     pathological feature in most aggressive types of cancer. The presented study follows a Phase~     I and a subsequent Phase I/II dose finding and efficacy study with the same agent in patients~     with a variety of cancers where 131I-L19SIP had shown an excellent tolerability and~     therapeutic benefit for some patients enrolled in the study.~   "
186374|NCT01125072|"~     Chest pain is one of the most common complaints that brings a patient to the emergency~     department (ED). The differential diagnosis of chest pain is broad and includes cardiac as~     well as non-cardiac diseases. One of the initial goals in the ED evaluation of a patient~     presenting with chest pain is to rapidly and accurately diagnose the presence or absence of~     acute coronary syndrome. The diagnostic accuracy of the initial routine evaluation is often~     limited and results in frequent admissions for patients presenting with chest pain for~     further diagnostic testing.~      Echocardiography has a high sensitivity and specificity for the diagnosis of acute myocardial~     infarction. Tissue Doppler imaging with strain and strain rate (SR) measurement is a new~     echocardiographic technique, which enables accurate assessment of regional left ventricular~     systolic and diastolic function. Prior studies have shown that abnormal strain and SR are~     highly sensitive markers of ischemia. Acute ischemia induces early systolic thinning and a~     delay in the onset of systolic thickening, a progressive decrease in the rate and degree of~     maximal systolic thickening, and an abnormal ischemia-related thickening which occurs after~     aortic valve closure. A major obstacle to the routine use of echocardiography in the ED is~     the need for portable studies, using heavy, bulky portable echo machines. There are currently~     available portable hand-held echo machines (GE-Vivid I) that produce high quality images and~     offer an opportunity to incorporate echocardiography into routine practice in the ED.~      This study will use of early, portable echocardiography, with detailed assessment of wall~     motion and left ventricular function by strain and strain rate measurements, for the~     evaluation of chest pain in the ED. It is hypothesized that an early with detailed left~     ventricular function assessment will be highly sensitive and specific for the diagnosis of~     myocardial ischemia, and will enable rapid triage of patients who present to the ED with~     chest pain.~   "
186375|NCT01125059|"~     What is the influence of methadone on postoperative analgesia after lumbar interbody fusion~     in opioid naïve patients or patients who are taking less than equivalent of 15 mg IV morphine~     each day? What is the incidence of opioid related postoperative side effects after the~     administration of methadone in the operating room?~   "
186376|NCT01125046|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with~     recurrent or progression meningiomas.~   "
186377|NCT01125033|"~     The purpose of this study is to determine whether vitamin C, vitamin E and their combination~     are effective in the treatment of RLS in hemodialysis patients.~   "
186378|NCT01125020|"~     The study is designed to investigate the effect of postoperative adjuvant chemotherapy in~     prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver~     transplantation.~   "
186379|NCT01125007|"~     This study compared the removal of dental biofilm between soft and medium toothbrushes. The~     patients refrained from performing mechanical or chemical plaque control for 96 hours to~     allow dental biofilm accumulation on the tooth surfaces. After the period of dental biofilm~     formation, the quadrants were randomized and the participants brushed different quadrants~     with soft and medium toothbrushes, with or without dentifrice. The plaque indices were~     analyzed by a blinded examiner before and after toothbrushing. The 2Tone was used for plaque~     disclosure and analysis was performed by the Quigley-Hein index modified by Turesky et al.~     (1970).~   "
186394|NCT01124812|"~     The aim of this feasibility study is to determine the therapeutic potential of the L19SIP~     antibody, labeled with the radionuclide 131I in combination with radiochemotherapy, for the~     treatment of patients with newly diagnosed, unresectable, locally-advanced NSCLC following~     the promising results with this agent in previous clinical studies.~      The L19SIP antibody is a fully human antibody, capable of preferential localization around~     tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a~     rare event in the adult (with the exception of the female reproductive tract), but it is a~     characteristic pathological feature for most types of aggressive cancer.~   "
186380|NCT01124994|"~     The accurate detection and therapy of adenocarcinoma originating from Barrett's oesophagus is~     challenging as current endoscopic techniques are unreliable for both the detection of high~     grade intraepithelial neoplasia (HGIN) within Barrett's mucosa and the correct measurement of~     the dimension of such neoplastic lesions. Confocal laser endomicroscopy (CLE) is a promising~     technology that could help to close this gap. Relying on first clinical trials of CLE, which~     showed remarkable results for the detection of Barrett's associated neoplasia, the~     investigators want to use CLE as targeting tool for endoscopic mucosal resection of HGIN in~     patients suffering from Barrett's oesophagus. CLE-mapping of neoplastic lesions will be~     documented and compared to the later performed histological evaluation of the resected~     specimen. If CLE is passing our challenge this will be another valuable proof of its high~     potential as reliable new endoscopic technology. Its usage could increase the en-bloc~     resection rate and decrease the amount of repetitive resections, which would remarkably~     improve the patients comfort.~   "
186381|NCT01124981|"~     Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy.~     Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events~     remains unknown.~   "
186382|NCT01124968|"~     eConsulta is a before and after quasi-experimental study without control group and its~     purpose is to asses the impact of virtual visits in primary care on the frequency of~     attendance of the patients to the primary care centre. The use of virtual consultations~     should lower the number of face to face visits to primary care. It also should create~     satisfaction to both users: primary care professionals and patients.~   "
186383|NCT01124955|"~     The aim of the present study is to assess the effectiveness of acupuncture using Yamamoto's~     method for the treatment of ANLBP using the following outcomes:pain,functional~     capacity,quality of life and number of 50 mg sodium diclofenac pills taken per day.~   "
186384|NCT01124942|"~     The Investigators will test the hypothesis that MGuard net protective stent, the~     investigational device, would be superior to conventional revascularization strategy (i.e.~     bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent~     percutaneous coronary interventions.~   "
186385|NCT01124929|"~     Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is~     sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular~     meningitis. Despite these recommendations, most physicians treating abdominal tuberculosis~     use antituberculous therapy for 9 months, sometimes even 12 months without any scientific~     justification. In a randomized controlled trial, Balasubramaniam et al reported no difference~     in success rate of 6mo (99%) vs 12 months (94%) antituberculous drugs (conventional strategy)~     in the treatment of abdominal tuberculosis.~      Although Directly Observed Therapy (DOTs) have been proved to be effective in patients with~     pulmonary tuberculosis, lymph nodal tuberculosis, however, there is a lack of data on~     efficacy of DOTS in other extra-pulmonary disease including abdominal tuberculosis.~     Therefore, there is an urgent need to establish the efficacy of DOTs strategy of~     antituberculous therapy in the treatment of abdominal tuberculosis.~      Therefore, the investigators planned to conduct a multicenter randomized controlled trial to~     determine the difference in the recurrence of disease after only observation for three months~     and three months extension of DOTs in a subset of patients with definite clinical response~     after 6 months of DOTs.~   "
186386|NCT01124916|"~     The purpose of this research is to determine if there is a difference in total costs of care~     and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC)~     compared to those undergoing the same procedure with the assistance of a robot.~      Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to~     result in shorter hospital stays, decreased blood loss and similar surgical outcomes as~     compared to open abdominal surgery. The decision to use robotic assistance is typically based~     on surgeon preference and robot availability. The study will compare the outcomes of cost,~     quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy~     utilizing the robot to those using traditional laparoscopic techniques.~      This research study is designed to compare the total costs and treatment success of these two~     surgical techniques. In addition, the study will compare outcomes of post-operative pain,~     quality of life, sexual function, return to normal activities and satisfaction with treatment~     outcome.~   "
186387|NCT01124903|"~     The sports medicine literature provides a consensus on what threshold values constitute~     euhydration (normal body water) using a variety of hydration assessment markers (e.g., blood,~     urine). The investigators add to this literature by providing decision levels for multiple~     body fluids which can be used as starting points for diagnosing and treating dehydration. At~     present, plasma osmolality (Posm) provides the best potential measure for static dehydration~     assessment (spot measure), while dynamic dehydration assessment (serial monitoring) is best~     accomplished using change values for Posm, urine specific gravity, or body mass (weight).~     These findings should be considered useful for clinical, military, and sports medicine~     communities.~   "
186388|NCT01124890|"~     SIAM III was a multicenter, randomized, prospective, controlled trial in patients with~     ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms.~     All patients received reteplase, aspirin in combination with ticlopidin, and heparin.~     Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI.~     The conservative group received elective PCI two weeks after fibrinolysis. In total 197~     patients were included, 163 were treated by PCI. The primary end point was the composite of~     ischemic events, death, reinfarction, and target lesion revascularization.~   "
186389|NCT01124877|"~     The purpose of this study is to assess the safety and tolerability of ziprasidone during a~     long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder~     (Manic or Mixed).~   "
186390|NCT01124864|"~     This study will assess the efficacy of AUY922, when administered weekly at 70 mg/m2, in adult~     patients with advanced Non-small-cell Lung Cancer (NSCLC), who have received at least two~     prior lines of chemotherapy. Patients will be retrospectively, and prospectively, stratified~     based on their molecular tumor etiology. The following strata was assigned: Patients with~     Epidermal growth factor receptor (EGFR) activating mutations, Patients with Kirstin Raus~     sarcoma virus (KRAS) activating mutations, Patients with EML4-ALK (anaplastic lymphoma~     kinase) translocations and patients that were both EGFR and Kras wild type.~   "
186395|NCT01124799|"~     The purpose of the study is to evaluate the potential effect of TMC435 on the sensitivity of~     the skin towards exposure to sunlight. TMC435 is a drug that is currently under development~     for treatment of chronic hepatitis C virus infection. This study will be conducted in healthy~     volunteers. Ciprofloxacin, a commonly used antibiotic, is used as a positive control as this~     drug is known to mildly increase skin sensitivity to exposure to sunlight. This study also~     evaluates the levels of TMC435 and ciprofloxacin in the blood circulation and the safety and~     tolerability of TMC435.~   "
186396|NCT01124786|"~     The purpose of this study is to determine whether CO-1.01 is safe and effective in the~     treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared~     with gemcitabine.~   "
186397|NCT01124773|"~     WHIMS-Y provides valuable information on the long-term effects on risk of cognitive~     impairment of hormone therapy in a subset of WHI participants in the WHI Hormone Trials.~     Following cessation of study-prescribed HT cognitive function and impairment were assessed.~   "
186398|NCT01124760|"~     The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on~     the pharmacokinetics of AZD9742.~   "
186399|NCT01124747|"~     The objective of this study is to assess the systemic disposition of ASP1585 after oral~     administration of 14C-labeled drug in healthy male subjects.~   "
186400|NCT01124734|"~     The investigators have recently observed that many patients who had received high dose~     Interleukin-2 (IL2) and failed to respond to it but who then go immediately to temozolomide~     seemed to enjoy extremely good responses which seem better quality and longer duration than~     typically observed for temozolomide alone. To date, the investigators have observed 5~     sequentially treated patients with metastatic melanoma who had failed high dose IL-2 but who~     then went on to receive immediate temozolomide. Two of these patients had complete responses~     and 3 had very strong partial response. In a recent phase II study of extended low dose~     temozolomide alone given in the same manner as the post IL-2 patients noted above, the~     response rate was 12.5% and all of these were partial responses only. The responses that the~     investigators observed were at a much higher rate of response as well as much better quality~     than expected for temozolomide. The responses were also better than those observed when~     temozolomide was given first and then followed by high dose IL-2. The investigators concluded~     that perhaps the major benefit the investigators observed was a result of the prior high dose~     IL-2 therapy modulated by the temozolomide and that the sequence of treatment was clearly~     crucial for this response.~   "
186401|NCT01124721|"~     Impaired WM is a central deficit in ADHD. A computerized training program, Cogmed, has been~     shown to increase WM capacity in children with ADHD. It is not known whether the training~     improves behavior associated with classroom learning, such as remaining on-task and~     inhibiting off- task behavior. The aim of this study is to utilize ecologically valid~     measures to investigate training's effect on observable ADHD behavior in conjunction with~     more standard measures. Subjects will be randomly assigned to a Cogmed versus an active~     placebo condition in which the tasks do not increase in difficulty level in a~     double-blinded fashion. The effects of the active Cogmed versus placebo computer training~     will be compared on measures in children with ADHD.~   "
186402|NCT01124708|"~     ADHD has been associated with persistent deficits in the efficient allocation of attention~     and supports the notion that regulation of the cholinergic system may improve these cognitive~     deficits in ADHD. It has been suggested that the effects of nicotine are most pronounced on~     tasks that demand effortful processing (Rusted and Warburton 1994). In addition, a recent~     theory proposes that the cholinergic system allocates additional attentional resources during~     tasks that are demanding (i.e. sustained attention, set shifting, etc; Sarter and Bruno~     1997). Thus it may be that in ADHD, cholinergic systems are under-responsive or~     under-developed and thus stimulation of nicotinic receptors via nicotinic agents may result~     in improved cognitive performance particularly on tests requiring effortful processing.~   "
186403|NCT01124695|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.~      PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with~     metastatic or recurrent breast cancer.~   "
186404|NCT01124682|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of 3-dimensional~     conformal radiation therapy in treating patients with bladder cancer who have undergone~     transurethral resection of the bladder.~   "
186405|NCT01124669|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in blood samples from patients with~     refractory non-small cell lung cancer previously treated with sorafenib tosylate.~   "
186406|NCT01124656|"~     The purpose of this study is to determine the safety and tolerability of~     pioglitazone-azilsartan, once daily (QD), in patients with type 2 diabetes mellitus.~   "
186407|NCT01124643|"~     This study will evaluate safety and clinical outcomes of treatment with Replagal in adult~     participants with Fabry disease who have completed Study TKT028 (NCT00864851).~   "
186408|NCT01124630|"~     Treatment with CS-1008 in combination with FOLFIRI (irinotecan, leucovorin, and~     5-fluorouracil [5-FU]) in subjects with metastatic colorectal cancer (CRC) who have failed~     first-line treatment that was not irinotecan-based.~   "
186409|NCT01124617|"~     The purpose of this study is to investigate the efficacy and safety of tapentadol~     extended-release (ER) tablets in Japanese participants with moderate to severe chronic~     (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the~     extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting~     after condition has healed).~   "
186410|NCT01124604|"~     The purpose of this study is to evaluate the efficacy, safety and to explore the~     pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the~     body and how they are removed from the body over time) of tapentadol hydrochloride extended~     release (ER) tablets in Japanese participants with moderate to severe chronic pain due to~     osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back~     pain.~   "
186411|NCT01124591|"~     Although screening, brief intervention, and referral to treatment (SBIRT) approaches are~     effective in reducing alcohol misuse and its associated risk-taking behaviors and negative~     consequences, there is little research demonstrating the effectiveness of SBIRT for illicit~     and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently~     seek medical care in emergency departments (EDs), particularly for reasons related to their~     misuse. As a result, the ED is well suited as a site to conduct an analysis of the~     effectiveness of SBIRT for this population.~      The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a~     randomized, controlled, trial that will include adult ED patients at a large, academic,~     trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who have~     a subcritical illness or injury and whose screening indicates illicit and/or prescription~     drug misuse. BIDMED participants will be randomized to receive screening only (SO) or brief~     intervention (BI) with appropriate referral to treatment. Participants will complete a~     battery of blinded baseline assessments using standardized instruments as well as adapted~     instruments specific to the aims of this study. All participants will undergo blinded~     follow-up assessments at three, six, and twelve months post-randomization. The primary~     hypotheses addressed in the BIDMED study are that, compared to participants in the SO arm,~     participants in the BI arm will show a significantly greater reduction in: (1) drug misuse~     within the prior 30 days at three months post-randomization, (2) behaviors associated with~     drug misuse at six months post-randomization; and (3) negative physical health, psychosocial~     health, and socioeconomic consequences at twelve months post-randomization. As a secondary~     aim, the impact of BI compared to SO will be assessed on participants contacting, enrolling~     in, and completing a drug treatment program. In addition, the impact of BI compared to SO on~     increasing uptake of HIV and hepatitis B/C screening will be measured. A mechanisms of change~     model that addresses the expected mediators and moderators of change to explain the effects~     of SBIRT in this setting will also be developed and tested. Further, the epidemiology of~     illicit and/or prescription drug misuse will be assessed in a random sample of ED patients.~   "
186412|NCT01124578|"~     PURPOSE OF EVALUATION: This study will verify & validate the acceptability of Egret's~     extended use product as compared to the existing daily change-out product. Based on an~     extensive in-vitro study, Egret's product confirmed significant kill for both positive and~     negative gram bacteria. In addition to meeting all of the current product requirements, total~     aerobic bio-burden on the catheters will be tested at various intervals for up to 10 days of~     use. The current used product will be used as a control group that is to be changed out daily~     as per current policy. The control group will be tested for total aerobic bacteria counts on~     the last day of use.~   "
186413|NCT01124565|"~     This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2)~     sequential applications.~   "
186414|NCT01124552|"~     The purpose of this study is to find out if an investigational drug, called RT001 Topical~     Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called~     lateral canthal lines, also known as crow's feet wrinkles.~   "
186415|NCT01124539|"~     The primary objective of this study is to determine the 6-month Progression free survival~     (PFS) when intravenous (IV) AR-67 is administered in adults with confirmed recurrence of GBM~     who have not recently (> 90 days) recurred after treatment bevacizumab (including patients~     who've received temazolamide, but no bevacizumab). The primary objective in the rapid~     bevacizumab failure group (< 90 days) is to determine the 2-month PFS.~   "
186416|NCT01124526|"~     The purpose of this study is to determine whether the rituximab administration with~     fludarabine and cyclophosphamide results, are better, than the ones obtained with~     conventional therapy such as CHOP (cyclophosphamide, adriamycin, vincristine, prednisone) and~     also to determine whether the rituximab administration as maintenance treatment during two~     years, increase the global clinical responses and the disease free time interval.~   "
186417|NCT01124513|"~     The gold standard method of assessing skin pigmentation is spectrophotometry; however, even~     as early as 1961 the potential for confounding by dilatation of blood vessels was recognized.~     (Monash 1961) Manual compression was used to express the blood from the field being measured.~     The red reflectance captured by reflectance spectrophotometer introduced an uncontrollable~     variable when measuring the tanning /pigmentation response of skin tone/color. Room~     temperature induced increased or decreased blood flow through the skin, which altered the~     findings by spectrophotometer. Other potentially confounding variables that changed blood~     flow were: recent exercise, and the flushing/blushing for emotional reasons. Since these~     conditions were difficult to reliably control on the sun exposed extremities,~     spectrophotometry was not a practical method to assess change in melanin over time as an~     outcome measure for efficacy of sun protection.~      Digital imaging with videodermatoscopy utilizing a portable device that is supported by a~     laptop computer, provides a high resolution digital image for analysis. (EasyScan) As~     described by Yamamoto et al (2008), applying the Image J freeware to quantify the~     pigmentation in the digital image holds promise as a practical objective method to reliably~     assess skin tones based on the melanin content in a non invasive manner. With~     standardization, the software and hardware may quantify the constitutive pigment in the sun~     protected skin as the melanin index.~   "
186418|NCT01124500|"~     The purpose of this study is to compare the effects, good and/or bad, of the Methylphenidate~     patch and a placebo patch (a patch that contains no medicine) on patients and their fatigue~     caused by cancer or by cancer treatment. The Methylphenidate patch contains a medication that~     is known to increase alertness and wakefulness. Oral methylphenidate has been used in the~     past to treat cancer related fatigue and is often used to treat unusual sleepiness. But this~     is the first time that the patch form is offered to try treating cancer fatigue in patients~     who cannot always swallow tablets.~   "
186419|NCT01124487|"~     Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid~     profile, insulin sensitivity and inflammatory markers.~      Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and~     inflammatory markers postprandially.~   "
186420|NCT01124474|"~     This study evaluates whether using information from a special arterial blood pressure monitor~     to guide how much fluid is given during surgery changes how long a patient stays in the~     hospital after the surgery. There is scientific evidence from using similar information from~     different devices that this technique might allow us to do a better job giving fluids during~     surgery and that this may be associated with a shorter hospital stay after surgery.~   "
186421|NCT01124461|"~     The goal of this study is to create a comprehensive database of Magnetic Resonance Imaging~     (MRI) and of pathology for patients with brain tumors. Both standard, advanced, and research~     MRI components may be included, these will be analyzed in comparison with pathology results~     if/when a biopsy is obtained, and also used to predict/evaluate responses to therapy. This~     study will create a database of de-identified MRI images which include these techniques so~     that brain tumors can be studied over time (longitudinally) in an organized manner.~   "
187010|NCT01116726|"~     A program of motivational interviewing plus enhanced community services in prevention of~     early childhood caries vs. enhanced community services alone for American Indian mothers and~     their children will reduce the childrens' decayed, missing, and filled tooth surfaces measure~     over a 3-year period.~   "
186422|NCT01124448|"~     In this study, the investigators will try to confirm if application of probiotic strains~     isolated from breast milk actually have a beneficial effect on women suffering lactational~     mastitis. This project has been design to offer an integrated vision of the effects of~     probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators~     propose a multidisciplinary approach involving the application of microbiological,~     immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The~     hypothesis is that probiotherapy will cause different effects on the host, and the objective~     is the finding of markers that may support the beneficial effect of the strain in such~     condition.~   "
186423|NCT01124435|"~     The aim of this study is to evaluate the antitumor activity and potential adverse effects of~     the combination celecoxib plus carboplatin in patients with recurrent, heavily pre-treated~     Ovarian Cancer (OC). The potential changes induced by the experimental combination on~     angiogenesis-related serum markers and quality of life measures will be also evaluated.The~     main objective is to evaluate the response rate. Secondary objectives are the~     following:toxicity;progression free survival;overall survival;duration of response;quality of~     life;modulation of angiogenesis-related molecules.~   "
186424|NCT01124422|"~     The objective of this study is to demonstrate that, when added to tiotropium (TIO),~     fluticasone propionate/salmeterol combination (FSC) DISKUS 250/50 significantly increases~     exercise endurance time (EET) in the endurance shuttle walk test (ESWT), compared to TIO~     alone. Male and female subjects at least 40 years of age with a diagnosis of Chronic~     Obstructive Pulmonary Disease (COPD) are eligible. Subjects will be screened and consented at~     or during a 6-week (wk) period prior to visit (V)1. The 4-wk run-in period begins immediately~     after V1, when subjects receive open-label TIO plus as-needed relief inhaler (identical~     formulations called albuterol in the US and salbutamol in Canada). At V2, subjects will~     perform an incremental shuttle walk test (ISWT) to establish their maximal walk response. The~     first ESWT will occur at V3. Subjects must demonstrate an EET of ≤20 min that is reproducible~     (EET from V3 and V4 varying by ≤2 min). Eligible subjects are then randomized at V5 to either~     FSC 250/50mcg DISKUS twice daily plus open label TIO 18 mcg daily, or placebo DISKUS twice~     daily plus open label TIO 18 mcg daily for the 4-wk treatment period. The last study visit is~     V6. The primary efficacy measure is the difference between the EET at V6 (wk-8) vs. V4 (wk-3;~     the last ESWT done before randomized study drug is given). Secondary efficacy measures~     include V6 vs. V4 comparisons in exercise dyspnea scale (EDS), exercise inspiratory capacity~     (EIC) and cardio-respiratory measurements (CRM), and V6 vs. V5 comparisons in dyspnea related~     to activities of daily living (baseline dyspnea index and transition dyspnea index~     interviewer-administered [BDI-TDI]) and quality of life (Chronic Respiratory Disease~     Questionnaire Self-administered Standardized [CRQ-SAS]). The safety measure will be an~     assessment of adverse events. We will also attempt to validate prospectively the minimal~     clinically-important difference (MCID) for a change in the EET through correlation with~     dyspnea and quality of life results.~   "
186425|NCT01124409|"~     This study aims to study the impact image guided radiotherapy with Cone beam CT will have on~     the outcomes(toxicities and response) of head and neck cancer when compared to 3D conformal~     radiotherapy without CBCT based setup error verification.Also,the various dosimetric~     variations in Adaptive RT will be studied.~   "
186426|NCT01124396|"~     Investigate safety/tolerability after repeated weekly doses intranasal administration of~     DSP-3025 comparator placebo to healthy male volunteers~   "
186427|NCT01124383|"~     This study aimed to compare two types of anesthesia (general anesthesia and local anesthesia~     with sedation) on the absorption of glycine in operative hysteroscopy.~   "
186428|NCT01124370|"~     The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve~     stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep~     fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly~     ventricular arrhythmias.~      The study is chronic in nature, such that subjects will undergo the implantation of an~     implantable pulse generator and stimulation lead. A sensing lead may also be placed during~     the initial implant procedure. Subjects will be followed for up to six-months on therapy to~     assess respiratory and heart failure outcomes. Following the six-month therapy visit,~     subjects will enter into a long-term follow-up phase until the completion of the study.~      It is anticipated that data obtained in this study will show that the proposed intervention~     can modify respiration with a low incidence of adverse effects. The results of this trial are~     intended to be used to develop a subsequent protocol for pivotal study.~   "
186429|NCT01124357|"~     STUDY HYPOTHESIS: Does outpatient NovaSureTM endometrial ablation alleviate excessive~     menstrual bleeding and improve life quality more effectively than outpatient ThermachoiceTM~     endometrial ablation?~   "
186430|NCT01124344|"~     The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe~     and tolerable~   "
186431|NCT01124331|"~     The primary question to be addressed by this study is: compared with a functional oxygen~     saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants~     from birth or soon after, result in a difference in mortality or major disability in~     survivors by 2 years corrected age (defined as gestational age plus chronological age)?~   "
186432|NCT01124318|"~     The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis.~     Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an~     enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to~     normalize metabolic and immune processes. Additionally, lactulose stimulates Bifidobacterium~     flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.~   "
186433|NCT01124305|"~     The main purpose of this study is to determine whether the surgical time required for primary~     total knee arthroplasty is significantly less when performed with Customized Patient~     Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by~     video camera, in order to time the length of surgery and each surgical step. The number of~     surgical trays required for each case will be recorded. As an additional endpoint, the~     investigators will measure limb and component alignment on x-rays to determine if these two~     methods achieve equivalent alignment results. The thickness of bone cuts will be compared to~     the surgical plan and to each other.~      The primary hypothesis is that the use of customized patient instrumentation will reduce the~     operative time required for total knee arthroplasty.~   "
186434|NCT01124292|"~     This study was intended to evaluate a new assistive neuro-technology, known as the Tongue~     Drive System (TDS), by its potential end-users, i.e. individuals with severe disabilities,~     who are the best experts for indicating the benefits and possible shortcomings of any new~     ANT. Our goal is to assess the acceptability and usability of the TDS for various tasks that~     are important in daily lives of these individuals, such as computer access, wheeled mobility,~     and environmental control.~   "
186435|NCT01124279|"~     To determine the bioavailability and the effect of food on the pharmacokinetics under fasted~     and fed conditions~   "
186436|NCT01124266|"~     Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of~     cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality~     from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent~     retrospective studies have shown that fellow involvement as a second observer may increase~     adenoma detection rate in colonoscopy.~      The aim of this prospective, multicenter, randomized study is to evaluate the impact when~     endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary~     outcome measure is the adenoma detection rate (ADR).~   "
186437|NCT01124253|"~     This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar~     prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with~     completely resected IB-IIIA non-small-cell lung cancer.~   "
186438|NCT01124240|"~     Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without~     interruption.~      Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with~     concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA~     < 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday,~     both TMZ and PCB seven days a week).~      After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in~     subsequent cycles) and PCB (50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given~     daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles.~   "
186439|NCT01124227|"~     Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor~     prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis~     (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA~     stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this~     condition and to find an optimal scheme.~      Objective: To improve symptomatology in severe chronic failure patients. Study design: Open,~     parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin~     (Extraneal®) with standard medical therapy..~      Study population: Patients with chronic refractory left ventricular congestive heart failure~     (LVEF < 30%, older than 18 years).~      Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with~     icodextrin (Extraneal®).~      Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive~     Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure:~     measured by reduction in unfavorable days (noted by patients in diaries and including days of~     hospitalization for CHF-deterioration and death).~   "
186440|NCT01124214|"~     Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early~     esophageal cancers (Intra Epithelial Neoplasia (IEN)). EM provides optical biopsies~     comparable to standard histology. Specifically, EM allows targeted biopsy rather than random~     mucosal biopsy during routine endoscopic surveillance of BE or evaluation EIN, which will~     improve the diagnostic yield of mucosal samples for BE IEN. Furthermore, when combined with~     high resolution endoscopy, EM may improve the overall in vivo detection of IEN in lesions as~     well as flat mucosa.~      EM will provide accurate place and size of IEN which will impact the physician's decision to~     biopsy or perform endoscopic mucosal resection (EMR). This could potentially minimize the~     number of unnecessary biopsies and as well as enable the physician to perform EMR at the time~     of the initial examination, rather than delaying endoscopic treatment after the pathology is~     available. This study is important because it will validate single center studies supporting~     the routine use of EM for screening and surveillance of BE.~   "
186441|NCT01124201|"~     The purpose of this study was to compare the efficacy of three exercise programs in patients~     with chronic low back pain: Segmental stabilization, superficial strengthening and~     stretching. Groups were contrasted regarding pain, functional disability and TrA muscle~     activation capacity. The three groups of exercise improved pain and functional disabilities,~     and the Segmental stabilization group was better in the ability to recruit TrA muscle.~   "
186442|NCT01124188|"~     The primary question addressed by this study is: Using a stepped care approach in primary~     care, what is the value of the combination of an antidepressant medication (Venlafaxine) and~     psychotherapy for seniors living with depression and chronic lower back pain when treatment~     with a low-dose of venlafaxine and supportive management (SM) has led to only a partial or~     non-response?~   "
186443|NCT01124175|"~     The objective of this study is to compare the rate and extent of absorption of losartan 100~     mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fed~     conditions.~   "
186444|NCT01124162|"~     The objective of this study is to compare the rate and extent of absorption of losartan 100~     mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fasting~     conditions.~   "
186445|NCT01124149|"~     This study was designed to evaluate if subjects who achieve complete remission after 8 weeks~     of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term~     outcomes and remain in remission longer compared with subjects who demonstrate only partial~     remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore,~     subjects who achieve either complete or partial remission will enter into a 12-month~     maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given~     QD. Remission status for the 2 groups will be evaluated and compared at the end of this~     12-month maintenance period. The data obtained from this study will provide scientifically~     meaningful information to demonstrate that achieving complete remission (clinical and~     endoscopic remission) is important for a better long-term prognosis, or that the current~     paradigm of symptomatic treatment is appropriate.~   "
186446|NCT01124136|"~     The purpose of this study is to study the use of neurostimulation in chronic advanced~     refractory heart failure.~      The study is determine if it is safe to use neurostimulation in patients with chronic~     advanced refractory heart failure and to also determine initial observations with regards to~     its potential effect on heart function and quality of life. The investigators hypothesis is~     that this study will show both safe and positive effect of neurostimulation on heart failure~     patients.~   "
186447|NCT01124123|"~     The purpose of this study is to assess the absolute bioavailability of an oral bilastine~     formulation (test drug) compared to the endovenous administration of an IV bilastine~     formulation (control drug) in healthy volunteers.~   "
186448|NCT01124110|"~     This is a clustered randomized control trial to test the Tobacco Tactics intervention among~     Operating Engineers (heavy equipment workers). The intervention group will be directed to the~     Tobacco Tactics website, and the control group will be directed to the state supported 1-800~     quit-now telephone hotline during routine annual safety training that all Operating Engineers~     are required to attend. The web-based quitting intervention includes provision of~     over-the-counter nicotine replacement therapy and will be followed by nurse email and/or~     telephone counseling. It is expected that Operating Engineers who are randomized to the~     Tobacco Tactics website intervention will have at least equal or greater decreases in smoking~     at 30-day and 6-month follow-up compared to those randomized to the 1-800-QUIT-NOW quit line.~     In addition, the investigators expect to find that Operating Engineers randomized to the~     Tobacco Tactics website intervention will: a) be able to accomplish tasks; b) be able to~     accomplish goals with skill and speed; c) be able to operate the system; d) be satisfied with~     the website; e) access the site repeatedly; and f) spend time on the site during the~     intervention period.~   "
186449|NCT01124097|"~     The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate~     (ESL) as therapy in subjects with Post-herpetic Neuralgia (PHN) over a 15 week treatment~     phase.~   "
186450|NCT01124084|"~     Application of health information technology be able to solve a lot of problems of medical~     management, and effective actions to achieve the purpose of medical care. The Personal~     Health Record (PHR), so that patients can have, access and update their health records and~     share health information to a new healthcare provider can avoid the duplication of a clinic~     procedures, reduce medical costs and time, and can make an appointment online, tracking~     vaccinations, check drug allergy, master with health-related information such as exercise,~     diet condition, and have no time constraints to the hospital clinic. In the future, PHR is~     expected to reduce medical errors, reduce costs, effective use of medical resources. Purpose~     of this study is to understand the impact to the staff's attitude and intention when they use~     the PHR, and to explore the medical records of personal health awareness and intention to use~     the relevant factors, the research result will be a reference to government authority or~     medical institutions in order to promote personal health record system in Taiwan.~      In this study, there will include the medical staff of three hospitals in Taipei, the~     Technology Acceptance Model (TAM model) based structured questionnaire will be used,~     questionnaire had tested by validity and reliability. The electronic questionnaires will be~     used, and apply the software SPSS and Amos17.0 descriptive and inferential statistical~     analysis.~   "
186451|NCT01124071|"~     To determine:~        1. the acceptability of a Korean diet to an Australian overweight and obese population~        2. which Korean recipes are easily prepared~        3. the effect of a Korean diet on weight, blood pressure, and metabolic complications of~          obesity in this population.~   "
186452|NCT01124058|"~     A prospective, randomized trial to compare the time taken to achieve a therapeutic INR upon~     re-starting warfarin at a loading dose (namely 1.5 times the maintenance dose for 3 days)~     compared to the known maintenance dose.~   "
186453|NCT01124045|"~     The primary objective of this study was to compare the safety and efficacy of Durezol™~     compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a~     pediatric population 0 to 3 years of age.~   "
186454|NCT01124032|"~     The study assesses the effect of Ritalin on working memory,attention,and decision-making~     measures in adults with ADHD and compares it to its effect on healthy adults, in a~     double-blind crossover design.We hypothesize that Ritalin will result in better performance~     in all measures,and that the improvement will be greater in the ADHD group.~   "
186455|NCT01124019|"~     The primary objective is to compare the predicted lifetime risk values produced by SNP panel~     assessment to the risk values produced by the prediction models that are most commonly used.~     A second objective is to examine whether the incorporation of risk assessment panels~     (standard or SNP based) can improve the positive value of breast biopsies in women with~     BIRADS 4 mammograms.~   "
186456|NCT01124006|"~     Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early~     lumbar disc degeneration~   "
186457|NCT01123993|"~     To determine the effect of Thai traditional music on cognitive function, psychological health~     and quality of sleep among Thai older individuals with dementia.~   "
186458|NCT01123980|"~     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood~     sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine~     once daily both in combination with metformin and glimepiride in Chinese and Japanese~     subjects with type 2 diabetes who have never received insulin before.~      The trial is conducted as a phase 4 trial in China and phase 3 in Japan.~   "
186459|NCT01123967|"~     This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy~     (NRT) to increase the population impact of tobacco cessation treatment for diverse, low~     income smokers. Population impact is the product of treatment utilization (i.e., reach or~     exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize~     treatment).~   "
186460|NCT01123954|"~     The present study will evaluate the safety in healthy people aged 1- 45 years (male and~     female) after single intramuscular (IM) dose of trivalent subunit inactivated influenza~     vaccine till the 30-days follow-up period.~   "
186461|NCT01123941|"~     This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197~     conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently~     licensed Vi polysaccharide vaccine.~   "
186462|NCT01123928|"~     The purpose of this study is:~        1. To determine whether an educational intervention designed based on studies in the area~          is effective in increasing acceptance of surgery and presentation to the hospital, when~          adjusting for a number of potential determinants of service uptake;~        2. To assess short-term impact of the educational intervention on knowledge about cataract~          and attitudes toward locally-available surgical services.~   "
186475|NCT01123759|"~     Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some~     fish contains high levels of mercury which is detrimental to fetal brain development. The~     hypothesis is that women who have previously consumed high mercury fish can reduce the~     mercury level in their bodies and improve their omega-3 levels in three months by eating fish~     that is high in omega-3 fatty acids and low in mercury.~   "
186463|NCT01123915|"~     This phase I study is the first step to determine if Opal immunotherapy may have potential~     utility as a treatment for HIV. Although effective treatments for HIV infection exist, they~     are limited by the requirement for life-long daily treatment, cost, side effects, and the~     development of resistance.~      There is a need for therapeutic approaches that induce or enhance T-cell immunity to control~     HIV disease. Overlapping Peptide-pulsed Autologous Cells (Opal) is a technique where~     autologous peripheral blood mononuclear cells (PBMC) or whole blood is pulsed with sets of~     overlapping peptides spanning whole proteins of HIV.~   "
186464|NCT01123902|"~     Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a~     simple device which has shown, when directed to the patients face, to be effective in~     relieving breathlessness.~      This phase II trial aims to determine the potential effectiveness of a hand-held fan to~     relieve breathlessness over time and to evaluate the recruitment into the study and the~     acceptance of the intervention and the control.~      The intervention to be tested is a HHF directed to the area of the face innervated by the~     second and third trigeminal nerve branches. A wristband was chosen as control under the~     assumption that distraction could serve as a placebo.~      The main outcomes for this study are uptake into the trial (proportion of patients from the~     longitudinal study participating in the RCT), adherence to the study, and use and acceptance~     of the intervention and the control. The main outcome for assessing the effect of the~     hand-held fan is change of severity of breathlessness between baseline and one month and two~     months, respectively.~   "
186465|NCT01123889|"~     The purpose of this investigator initiated study is to clinically evaluate the efficacy of a~     new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears.~     This treatment consists of a platelet rich plasma injection into and around the rotator cuff.~     It is thought that this treatment will dramatically improve outcomes for patients suffering~     from these two conditions.~      Subjects will be randomized by choosing a slip of paper from an envelope. This process will~     randomize 25 patients to the experimental group, and 25 patients to the control. The~     experimental group will undergo a blood draw, allowing for an injection of platelet rich~     plasma around the rotator cuff. The control group will undergo a corticosteroid injection~     into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be~     followed for three months for pain, and will fill out questionnaires at six weeks and three~     months post injection, which will give insight into functionality and pain changes that the~     rotator cuff is experiencing due to treatment.~      Subjects will be outpatients. Subjects may include employees, students, minorities, and~     elderly, although no subsets of these will be formed.~      Subjects will be between 18 and 89 years of age.~      In total, subject participation will last approximately 3 months.~   "
186466|NCT01123876|"~     Assess whether the combination of ABT-888 with FOLFIRI has activity in subjects with gastric~     cancer.~   "
186467|NCT01123863|"~     A preliminary study was conducted involving 88 three-year-old children with sickle cell~     disease (SCD) who were followed at the St. Jude Children's Research Hospital Sickle Cell~     Center. They were offered developmental screening with the Brigance Preschool Screen-II test~     during their regular clinic visits from January 2006 to August 2008. Data from this work~     showed that 50% of 3 year old children with SCD had low developmental screening scores. In~     addition, the low scores were found to be associated with less parental education and with~     speech deficits. However they were not associated with sickle cell genotype and hemoglobin~     level.~      The primary goal of this study is to prospectively administer Brigance Preschool Screen -II~     to 3 year old children with SCD and 3 year old children without SCD who come from similar~     socioeconomic backgrounds and compare the results between the two groups.~   "
186468|NCT01123850|"~     To compare radiographic data collection from patients undergoing instrumented PLF with~     CopiOs(R) BVF or instrumented PLF with autologous bone and to assess overall clinical~     outcomes. Patients will serve as self controls.~   "
186469|NCT01123837|"~     The purpose of this investigator-initiated study is to see if giving dextrose fluid in the~     veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic,~     gynecologic and breast outpatient surgery patients and at what blood surgery level. The~     reason for this study is that IV dextrose has been shown to decrease the incidence of PONV~     and the use of medications to treat PONV, while leading to sooner discharge after surgery.~     This can decrease overall healthcare cost and improving patient satisfaction.~   "
186470|NCT01123824|"~     Primary Objective:~        -  Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate~          (ADP)-induced platelet aggregation after administration of a standard dose regimen of~          clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and~          female subjects~      Secondary Objectives:~        -  Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg~          loading dose followed by 150 mg/day for 4 days)~        -  Compare the pharmacokinetic profiles of clopidogrel active metabolite between the~          selected groups of genotyped subjects and the 2 dose regimen~   "
186471|NCT01123811|"~     Based on the current promising results with irinotecan and cetuximab in patients with~     recurrent metastatic colorectal cancer, and the excellent results of Irinotecan and 5-FU in~     gastric cancer , the present clinical study to evaluate the overall response rate, the time~     to progression and the overall survival of the combined treatment of cetuximab and irinotecan~     and 5-FU in patients with esophagogastric cancer is urgently needed.~   "
186472|NCT01123798|"~     The purpose of this study is to define the reliability and accuracy of Near Infrared~     Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and~     noninjured extremities over time. The investigators hypothesize that this technology,~     combined with vital signs, intracompartmental pressures and clinical examinations, will be~     useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS,~     and evaluating the adequacy of fasciotomy in patients treated for ACS.~   "
186473|NCT01123785|"~     The purpose of this study is to evaluate how tolerable, safe, and effective it is to give~     INO-8875 eye drops to adults with glaucoma or ocular hypertension.~   "
186474|NCT01123772|"~     The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye~     drops at different concentrations to normal older healthy adult volunteers for two weeks.~   "
188771|NCT01093625|"~     The purpose of this study is to evaluate the effect of an investigational silicone hydrogel~     soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle~     wearers.~   "
186476|NCT01123746|"~     Objective: To evaluate the predisposing factors associated with abnormal laboratory findings~     in patients who came to the emergency room due to a first seizure.~      Methods: Patients were divided into separate groups based on normal and abnormal laboratory~     results for sodium, potassium, calcium, and glucose. The difference in age, gender, whether~     this was the first attack, whether there was fever, whether there were gastrointestinal~     symptoms, the duration and pattern of the seizure, and whether there was a seizure at the~     emergency department, were evaluated.~   "
186477|NCT01123733|"~     This project aims to analyze and compare the prevalence of breastfeeding at one hour after~     delivery, discharge from hospital, one month, two months, four months, and six months after~     delivery and to examine factors associated with breastfeeding between baby-friendly hospitals~     and non baby-friendly ones. Employing a prospective cohort design, the study population is~     mothers who gave lived births in Taiwan area from August, 2009 to March, 2010. At least 11~     hospitals both in non baby-friendly and baby-friendly hospitals from northern, middle,~     southern and east areas will be asked for permission to join this study (totally 22~     hospitals). The research assistants will contact each eligible participant in the hospitals~     and explained the purposes and procedure of the study. Once permission was obtained, mothers~     will be asked to write a questionnaire and their telephone numbers as well as address for~     future contacts. After the individual case returned home, the collection of data was mainly~     via telephone interviews. However, if the individual case could not be contacted more than~     two times via telephone, she would be surveyed by questionnaire. The collection of data~     showed the state of mother milk feeding one month, two months, four months, or six months~     after delivery. 1, 000 effective questionnaires were expected to be returned (500 ones from~     baby friendly hospitals; 500 ones, from non baby-friendly hospitals.) The survey include~     questions on breastfeeding experiences (one hour after delivery, discharge from hospital, one~     month, two months, four months, and six months), planned duration of breastfeeding,~     socio-demographic information, perceived baby-friendly practices at hospital, social support~     regarding breastfeeding, prior infant feeding method, maternal and infant health conditions,~     mother's working plan, receipt of formula samples and commercial message during perinatal~     period. The researcher hopes that based on the research results we can have a better~     understanding of the influencing factors of promoting mother milk feeding in non~     baby-friendly hospitals, and that we know how to raise the breastfeeding rate in Taiwan area,~     which can serve as references for the governmental policies.~   "
186478|NCT01123720|"~     Recently The Department of Health of Taiwan has launched the Internationalize Medical~     Services Flagship Program, expecting to promote Taiwan's high-quality of medical services to~     the international market, and anticipating customers stroll in, medical services walked~     out.~      In order to avoid expansion of this program might alienate the rights and best interests of~     local people seeking medical services, therefore, this research project is a join effort of~     experts to form an advisory counsel; by collecting most current international medical~     services data; then using both qualitative and quantitative questionnaires to investigate~     whether by implementation of internationalize medical services will cause great impact on~     local people.~      To study the various of insurance income of health care organization after they promote~     international medical services; and to understand the impact of assess to medical care and~     quality of medical services to local people due to internationalize medical services.~      The last through advisory counsel, to make specific recommendations on mechanism of~     management and to set evaluation of indicators to monitor international health care, to avoid~     edge out local people the right of seeking medical care to ever happened, and to aid future~     planning of policy and implementation.~   "
186479|NCT01123707|"~     This will be a multicenter, 52-week, open-label study designed to assess the safety and~     tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with~     major depressive disorder (MDD). Enrollment into the study will be from eligible subjects who~     have completed participation in Protocol 31-08-255, 31-08-256, or 31-08-263 (rollover~     subjects).~   "
186480|NCT01123694|"~     Xeroderma Pigmentosum (XP) is a rare skin condition that causes extreme sensitivity to the~     sun and an increased incidence of skin cancers. The purpose of this study is to find out more~     about XP patient experiences and their quality of life.~   "
186481|NCT01123681|"~     The purpose of this study is to determine how often ventilator associated pneumonia happens~     in the current intensive care units, and how types of endotracheal tube affect its~     occurrence.~   "
186482|NCT01123668|"~     The purpose of this study is to evaluate how nicotine, withdrawal from nicotine, and~     methylphenidate (a drug used for the treatment of ADHD) affect the brain of smokers with and~     without ADHD while doing tasks in an functional Magnetic Resonance Imaging scanner.~      Study Hypotheses:~        1. compared to non-ADHD smokers, smokers with ADHD will exhibit greater abstinence-induced~          decrements in response inhibition performance and reward and greater concomitant~          disruptions of brain activity~        2. administration of MPH to abstinent smokers will ameliorate response inhibition~          performance and reward deficits and task-related brain activation and this effect will~          be greater among ADHD smokers~        3. genetic markers of dopamine neurotransmission will moderate abstinence- and MPH -~          induced changes in task-related brain activation across tasks.~   "
186483|NCT01123655|"~     This is a Phase I clinical trial to determine whether orally administered APL A12 at one or~     more doses is superior to placebo in effecting a 25% reduction in interferon (IFN)~     stimulation index in 1(II)-stimulated culture of peripheral blood mononuclear (PBMC) obtained~     from patients with Rheumatoid Arthritis (RA), which will be the primary outcome variable. In~     an effort to learn more about the mechanism of action of APL A12, the investigators will~     assess Th1/Th2/Th3 cytokine production in supernatants from 48h and 144h cultures of PBMC~     stimulated by 1(II) and by APL A12 above. The investigators will assess function of CD4+~     CD25+ T regs to determine whether APL A12 improves their suppressive function. Flow cytometry~     combined with intracellular cytokine staining will be used in an effort to determine which T~     cell subset(s) is/are experiencing shifts in cytokine expression.~   "
186484|NCT01123642|"~     Functional recovery is of the utmost importance to evaluate in our returning Operation~     Enduring and Iraqi Freedom Veterans so that we can better understand their needs and~     experiences during the readjustment process from warzone to civilian life. Although most~     soldiers are resilient, concerning rates of PTSD (12-20%) and depression (14-15%) have been~     found, and as many as 24-35% report drinking more alcohol than they intended (Hoge et al.,~     2004). The current study proposes to follow returning Veterans for a one-year period to~     evaluate factors that influence the readjustment process and functional impairment. This~     information should guide the development of early intervention and treatment programs to help~     recovery.~   "
186532|NCT01123005|"~     Hypoxia, meaning a lack of oxygen, has been associated strongly with a wide range of human~     cancers. Hypoxia occurs when tumor growth exceeds the ability of blood vessels to supply the~     tumor with oxygenated blood. It is currently understood that hypoxic tumors are more~     aggressive. Current methods for measuring hypoxia include invasive procedures such as tissue~     biopsy, or insertion of an electrode into the tumor. EF5-PET may be a non-invasive way to~     measure tumor hypoxia.~   "
186485|NCT01123616|"~     After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal~     surgeries. The goal of the investigators randomized, prospective, multicentric,~     internet-based study is to compare rate of SSI after surgery of colon and rectum by using~     triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are~     involved in this study. Two arms are separeted by computer randomization at abdomial wall~     closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).~     Triclosan is an antiseptic material which the investigators hope will provide better local~     infection control at the site with reducing the risk of bacterial colonisation.~   "
186486|NCT01123603|"~     To the investigators knowledge there is no research data published to date regarding the~     lower urinary tract symptoms in women with leiomyomas. The primary aims of this study are:~        1. To determine prevalence of lower urinary tract symptoms in patients who present for care~          for symptomatic leiomyomata.~        2. To compare change in lower urinary tract symptoms within treatment groups measured by~          the UDI-6 total before and at six months after three common treatments for symptomatic~          uterine fibroids including: hysterectomy, myomectomy, or uterine artery embolization.~      The study proposed here will hopefully answer the question if one particular therapy is~     appropriate to treat fibroids and relieve lower urinary tract symptoms.~   "
186487|NCT01123590|"~     The purpose of this study is to study characteristics of patients with thymoma in~     Chulalongkorn hospital between 2003-2007.~   "
186488|NCT01123577|"~     Background:~      Hypertension (HTN) is a major risk factor for cardiovascular disease (CVD), the leading cause~     of death in the United States and New York City (NYC). One in 4 NYC adults has hypertension,~     with higher prevalence in both Blacks and Latinos compared to Whites (Angell 2008). In NYC,~     only 65% of all adults with HTN and on treatment are controlled (Angell 2008).~      Self-blood pressure monitoring (SBPM) is associated with reduced blood pressure in patients~     with hypertension (Cappuccio 2004). Studies suggest that SBPM may increase control either by~     inducing clinicians to titrate medication more actively, (Agency for Healthcare Research and~     Quality 2002) by engaging patients to participate in their own health care, (Taylor 2007) or~     a combination of the two.~      However, minimal research has been done to evaluate the effectiveness of SBPM in different~     racial and/or ethnic groups or in low income populations or to discern effective patterns of~     SBPM use by patients. Best practices for integration of self monitoring into HTN into regular~     treatment have also yet to be established.~      Objectives:~      The goal of this study is to assess the impact of SBPM under conditions consistent with~     existing community health clinic resources and infrastructure in NYC's medically underserved~     neighborhoods using commonly available automated home BP monitors. By using a community~     clinic's electronic health record (EHR) and automated BP monitors with the capability to~     transmit readings to a research database, we can facilitate a more rigorous evaluation of a~     pilot SBPM intervention and assess patterns of home monitor use and clinical management and~     their association with outcomes.~      The three specific aims of this intervention are to:~        1. Assess whether use of SBPM reduces elevated BP and increases HTN control to similar~          levels in two historically understudied minority populations, Blacks and Latinos.~        2. Confirm pilot findings by assessing the impact of SBPM on BP and HTN control compared to~          usual care using randomized controlled trial methodology.~        3. Develop standards and refine guidance for the effective use of SBPM that can be easily~          communicated to key stakeholders.~   "
186489|NCT01123564|"~     This study aims to assess if Lucentis injection applied into the eye is superior to~     conventional treatment concerning the prevention of visual loss in patients having clinically~     significant macular edema secondary to retinal vein occlusion~   "
186490|NCT01123551|"~     In the emergency department, 60% of patients have an acute pain. Appropriate management of~     acute pain is a public health priority according to who recommendations. Nebulized morphine~     has been extensively studied in children but less well in adults.~      It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than~     intravenous (IV) method.~   "
186491|NCT01123538|"~     The purpose of this study is to compare combined postmenopausal hormone therapy natural~     progesterone to the one containing synthetic progestagen (i.e. chlormadinone acetate) at the~     blood transcriptome level.~   "
186492|NCT01123525|"~     60 elective patients for CABG will be included to receive either standard hyperkalemic~     cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium~     is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal~     potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead~     of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The~     patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive~     blood samples to measure release of cardiac enzymes.~   "
186493|NCT01123512|"~     The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF~     Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic~     vertebral compression fractures of the thoracic or lumbar spine.~   "
186494|NCT01123499|"~     Background:~        -  Many treatments for immune system disorders involve the use of stem cells that have been~          collected from blood marrow. To obtain these stem cells without surgery, individuals~          receive granulocyte colony-stimulating factor (G-CSF) to encourage the production of~          stem cells that can be collected through blood donations. However, not all patients or~          normal donors respond to G-CSF alone.~        -  Plerixafor, recently approved by the Food and Drug Administration, is different from~          G-CSF but also allows stem cells to be collected from donated blood. However, more~          research is needed on the quality and viability of the stem cells collected after using~          both G-CSF and plerixafor.~      Objectives:~      - To collect and study the blood cells produced after treatment with G-CSF and plerixafor in~     healthy volunteers.~      Eligibility:~      - Healthy volunteers between 18 and 65 years of age who are eligible to donate blood.~      Design:~        -  Participants will be screened with a medical history, physical examination, and initial~          blood tests.~        -  At the start of the study cycle, participants will receive daily morning injections of~          G-CSF for 5 days. These may be given at the clinical center or by the participant after~          teaching, depending on the participant s preference.~        -  On the morning of Day 4, participants will visit the clinical center to provide a blood~          sample after the injection. On the evening of Day 4, participants will receive an~          injection of plerixafor.~        -  Participants will have the final injection of G-CSF on the morning of Day 5, and will~          provide another blood sample.~        -  On Day 5, participants will have apheresis to separate the stem cells from the rest of~          the blood. The apheresis may take up to 5 hours to complete.~        -  The study will end after a follow-up phone call 7 to 14 days after the apheresis~          procedure.~   "
186495|NCT01123486|"~     The primary objective of the proposed work is development of a high resolution~     pharmacokinetic-pharmacodynamic (PK-PD) model of hydromorphone for experimental pain stimuli,~     ventilatory depression, and surrogate biomarkers of opioid effect that will allow the~     fingerprinting of hydromorphone. This fingerprint will serve as the basis for the development~     of dosing strategies that efficiently maximize analgesia while minimizing ventilatory~     depression and sedation. For example, this high-resolution fingerprint will allow precise~     estimation of an initial hydromorphone target effect site concentration (Ce) from those of~     effectively administered synthetic opioids with previously determined high-resolution~     fingerprints (i.e., remifentanil or fentanyl), thereby minimizing underdosing of~     hydromorphone for analgesia and minimizing side effects.~   "
186533|NCT01122992|"~     The main purpose of this study is to evaluate the use of limbal relaxing incision (LRI) for~     astigmatic correction. LRI is a procedure where a pair of incisions is made in the peripheral~     part of the cornea so as to alter its shape and improve the focusing power of the eye.~   "
186496|NCT01123473|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin hydrochloride, cisplatin,~     fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not~     yet known whether giving combination chemotherapy together with or without lapatinib~     ditosylate is more effective in treating patients with cancer of the stomach or~     gastroesophageal junction.~      PURPOSE: This randomized phase II trial is studying how well epirubicin hydrochloride,~     cisplatin, and fluorouracil or capecitabine works when given together with or without~     lapatinib ditosylate as first-line therapy in treating patients with stomach cancer or~     gastroesophageal junction cancer.~   "
186497|NCT01123460|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib~     hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on~     cells. It may also help doctors understand how well patients respond to treatment.~      PURPOSE: This research study is studying biomarkers predicting response in patients with~     non-small cell lung cancer previously treated with erlotinib hydrochloride.~   "
186498|NCT01123447|"~     The purpose of this study is to determine if surgery using a plate and screws to fix a~     forearm fracture (ulnar shaft) will improve functional outcome compared to non-operative~     treatment out to 1 year of follow-up. It is hypothesized that in skeletally mature patients~     with isolated ulnar shaft fractures, the patients treated with surgery will have improved~     functional outcomes compared to non-surgical treatment with below-elbow cast at 1-year~     follow-up. This will be measured by the Disabilities of the Arm, Shoulder and Hand (DASH)~     scores. Secondary outcomes will include SF-36, range of motion, pain, grip strength, return~     to work, and time to union.~   "
186499|NCT01123434|"~     The primary objective is to assess the efficacy of immediate postoperative adjuvant hormonal~     treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced~     Chinese prostate cancer patients.The secondary objective is to assess the quality of~     life（QoL）of the high risk localised or locally advanced Chinese prostate cancer patients with~     immediate postoperative adjuvant hormonal treatment and get the information of immediate~     postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).~   "
186500|NCT01123421|"~     Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of~     osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS~     parameters will be able to discriminate between postmenopausal women with osteoporotic~     fractures when compared to matched controls without history of osteoporotic fracture.~   "
186501|NCT01123408|"~     This was a double-blind randomized study with three treatment arms: clozapine, olanzapine and~     haloperidol. We compared these three medications in the treatment of aggressive behavior over~     a 12 week period.~   "
186502|NCT01123395|"~     The purpose of this study is to evaluate and compare the relative bioavailability of a single~     0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice~     relative to the same dose given as an intact tablet to healthy subjects following an~     overnight fast.~   "
186503|NCT01123382|"~     Post-stroke shoulder pain is a major rehabilitation problem affecting moderate to severely~     impaired stroke survivors. Surface electrical stimulation (ES) of muscles surrounding the~     hemiparetic shoulder has been demonstrated to be beneficial, but despite the evidence for~     therapeutic benefit, the clinical implementation of surface ES for poststroke shoulder pain~     has been difficult. In order to address the limitations of surface ES, the investigative team~     pioneered the development of percutaneous intramuscular (IM) ES for the treatment of~     post-stroke shoulder pain. However, prior to acceptance by the clinical community, additional~     gaps in the scientific and clinical knowledge need to be addressed. This study begins to do~     so. The primary objective is to estimate the relative pain reduction associated with IM ES~     vs. usual care. We hypothesize that the IM ES group will exhibit a larger effect size with~     respect to pain reduction compared to usual care. A secondary objective is to estimate the~     effect on health related QOL of IM ES vs. usual care. Demonstration of improvement in QOL~     will validate the clinical relevance of the intervention. We hypothesize that the IM ES group~     will exhibit greater improvement in health related QOL compared to usual care.~   "
186504|NCT01123369|"~     To determine the retinal and choroidal thickness in patients with sickle cell disease~     compared to age, race matched population without sickle cell disease to allow a better~     understanding of the clinical manifestations of sickle cell retinopathy. The purpose of this~     research study is to evaluate the relationship between sickle cell disease and the eye. The~     research study is recruiting African American population with or without Sickle Cell Disease.~     The investigator in charge of this study is Dr E. Bowie. Approximately 60 subjects of both~     sexes will be enrolled at the Medical University of South Carolina.~   "
186505|NCT01123356|"~     The purpose of this research is to evaluate the safety and effectiveness of the drugs~     lenalidomide and ofatumumab in the treatment of chronic lymphocytic leukemia (CLL).~   "
186506|NCT01123343|"~     To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR~     MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing~     information during cataract or refractive lens exchange surgery. Device images, safety~     results and surgeon questionnaire will demonstrate that the TrueVision system provides clear~     images to assist surgeons during LRI or capsulorhexis procedures.~   "
186534|NCT01122979|"~     Primary Objective:~      >To obtain an estimation for both treatment groups of the proportion of patients that reach~     the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group.~      Secondary Objectives:~        -  Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and~          after each period of treatment.~        -  Incidence of confirmed symptomatic and nocturnal hypoglycemia.~        -  Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover).~          >Weight variation for each period of treatment.~        -  Creatinine clearance at baseline and after each period of treatment.~        -  Overall safety: Incidence of adverse events.~   "
186535|NCT01122966|"~     The investigators plan to evaluate the additive effect of intracameral and subconjunctival~     injections of bevacizumab in trabeculectomies with other antimetabolites.~   "
186536|NCT01122953|"~     To investigate the bioequivalence between two compounds (phenytoin and epamin) by a~     randomized, single dose study under fasting conditions in healthy volunteers.~   "
186507|NCT01123330|"~     The Detroit Dental Health Project (DDHP)aims to promote oral health and reduce disparities~     within the community of low-income African-American children (0-5 years) and their main~     caregivers (14+ years), living in the City of Detroit. The driving theme of the Project is to~     identify determinants and design interventions to answer the following question: why do some~     low-income African-American children and their main caregivers have better oral health than~     others who live in the same community? The Project has 3 support cores, 4 research core~     projects and 1 pilot study. The Project has selected a multistage random sample of~     African-American families living in the poorest 39 Census Tracts in the City of Detroit. A~     total of 1,022 families were recruited and interviewed at a community center in Detroit~     during the year 2 (2002). We have collected data about the social characteristics of parents,~     families, and neighborhoods that are associated with disparities in oral health; lead levels~     in saliva and blood of the caregivers; and dietary intake. All these families will be~     recalled in the year 4 (2004) and year 6 (2006) for longitudinal data collection. We are~     currently developing a tailored multi-media educational intervention (Project #3), based on~     data collected in the first phase (2002). The educational intervention will be administered~     using a randomized controlled design in year 4 (2004). Additionally, the Project is~     evaluating the impact on access to dental care of a state-funded experiment on utilization~     where Medicaid children are managed like privately insured patients (Project #4).~   "
186508|NCT01123317|"~     The purpose of this study is to assess how oxytocin delivered intranasally changes regional~     brain blood flow measured by positron emission tomography (PET) in conjunction with oxygen-15~     labeled water in persons with schizophrenia. The objective is to better our understanding of~     oxytocin's role in the modulation of social judgment in schizophrenia and provide more~     information as to potential uses of oxytocin or a similar drug analog in treating certain~     features of schizophrenia and other neuropsychiatric disorders.~   "
186509|NCT01123304|"~     This research is being done to find out the safety of MORAb-028 in subjects with metastatic~     melanoma.~   "
186510|NCT01123291|"~     The purpose of this study is to evaluate the long term clinical impact of routine follow-up~     coronary angiography after percutaneous coronary intervention (PCI). The primary endpoint is~     a composite of death/myocardial infarction/stroke/emergency hospitalization for acute~     coronary syndrome/hospitalization for congestive heart failure at 3-year after percutaneous~     coronary intervention.~   "
186511|NCT01123278|"~     Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone~     replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to~     address the effects of TRT on insulin resistance, body composition and pro-inflammatory~     status in naïve patients with MetS and HG.~   "
186512|NCT01123265|"~     The purpose of this study is to determine whether DC-STAMP, a protein on the surface of~     osteoclast precursors (OCPs), can be used as a biologic marker in Psoriatic Arthritis (PsA).~     With this marker the investigators hope to learn more about how OCPs develop as well as find~     out if DC-STAMP predicts PsA severity and how well treatment works in PsA.~   "
186513|NCT01123252|"~     The study aims to examine the effect of probiotics on the clinical symptoms of allergic~     rhinitis and to elucidate some of the immunological mechanisms involved.~   "
186514|NCT01123239|"~     In this study, we are testing the effectiveness of an intervention known as Coached Care to~     improve health outcomes and quality of care of patients being treated for type 2 diabetes,~     particularly patients in underserved populations. The intervention involves training members~     of minority communities who have diabetes to be coaches, teaching minority patients the~     skills needed to participate effectively in care during office visits, as they present for~     those visits. Coaches follow patients for 9 routine consecutive visits, reinforcing~     participation skills before and between their routine office visits.~   "
186515|NCT01123226|"~     There will be no difference between trigger point therapy and spinal manipulation in~     correcting a spine joint dysfunction in the back~   "
186516|NCT01123213|"~     Pessaries are mechanical support devices worn vaginally to treat the symptoms of pelvic organ~     prolapse, such as vaginal pressure or a vaginal bulge. Pessaries are one of the options along~     with surgery and expectant management for pelvic organ prolapse. As the aging population~     grows, more patients will need treatment for pelvic organ prolapse. Various studies have been~     conducted previously to identify patient parameters predictive of successful pessary fitting~     and continued use. Our study is a retrospective chart review to identify patient~     characteristics predictive of successful pessary fitting and use, specifically focusing on~     the parameters of POPQ, pelvic organ prolapse quantification exam, and the ratio of the~     genital hiatus, which is the length of the vaginal opening, and total vaginal length.~   "
186517|NCT01123200|"~     The investigators are developing a tool to help people who are severely paralyzed. This tool~     is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic~     devices.~      This study allows a person with ALS to communicate, control their wheelchair tilt and perform~     other tasks using a BCI, thus increasing their independence.~   "
186518|NCT01123187|"~     This single center phase 2 clinical trial, is designed for confirming the efficacy and safety~     of sequential islet allotransplantation with steroid free immunosuppression in patients with~     previous kidney transplantation.~   "
186537|NCT01122940|"~     Mexican healthy volunteers will receive the current form of the drug (under the name of~     Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.~   "
186538|NCT01122927|"~     This is an open-label study consisting of a screening period, a conversion/titration phase~     (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.~      The study will enroll new subjects (hereafter referred as de novo subjects) with~     schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic~     features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as~     Study 266). All de novo subjects must enter the screening period of the study. Subjects who~     are screened and are not required to go through Phase 1 will complete a Phase 2 baseline~     visit prior to their participation in Phase 2.~      Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy~     Study~   "
187591|NCT01109134|"~     The aim of this randomized trial is to compare the efficacy of high dose tirofiban~     administered as either an intracoronary bolus alone or as an intravenous bolus followed by a~     maintenance infusion with respect to microvascular perfusion and long term left ventricular~     infarct size, volumes and function.~   "
186519|NCT01123174|"~     The suicidal behaviors are phenomena eminently multifactorial. It is thus always difficult to~     define univocal strategies of prevention of suicide repetition, during the emergency stay,~     i.e. almost in general population. One find 23 clinical trials in this topic in the past 25~     years, and 18 are negative. The majority of the positive trials have the concern of being~     dissociated from an assumption of responsibility of care strictly speaking, to adopt a~     position méta, nearer to the concept of case management: how to remain in contact with~     the suicide attempter, without forcing it in this every day life, replacing a possible~     proposing, but assumption of responsibility resources reliable and quickly accessible in the~     event of at risk situation? Each one of these studies tests devices which seem more~     appropriate to such or such characteristic of this population, by retaining only simple~     criteria like the sex, the number of former suicide attempts, the proposal or not for an~     assumption of responsibility of care, the observance or not with the plan of care. Thus, it~     would seem interesting to combine these approaches in an algorithm entitled ALGOS.~      Main aim: To test the effectiveness of this algorithm of case management, named ALGOS, in~     reducing the number of death by suicide, in terms of reduction of suicide re-attempts and the~     number of loss of contact patients in the ALGOS group during 6 months period, compared to a~     control group of suicide attempters treated as usual (i.e. primarily transmitted to the~     attending physician).~      Secondary objectives: To evaluate, according to the method validated by Beecham in 1992,~     direct medico-economic impact in the year which follows the introduction of algorithm ALGOS.~     Reduction of the other suicidal behaviors in 6 months (reduction in the full number of~     suicidal repetitions in each group, evolution of the score of suicidal ideation, etc…). To~     evaluate the effect of the algorithm, at the 13th month. To study the possible differences~     within the time in terms of suicidal repetitions in the 2 groups. To propose different~     profiles of answers according to psychopathology, the number of suicide attempts, suicidal~     character, the sex,…~      Methodology: Comparative simple blind prospective multicentric controlled study~   "
186520|NCT01123161|"~     The purpose of this trial is to determine whether the combination of thrombolysis and~     hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.~   "
186521|NCT01123148|"~     The investigators want to develop a brain-computer interface (BCI) that will eventually allow~     people who are completely paralyzed to independently control the tilt feature on their power~     wheelchairs. This study will allow healthy volunteers to test the feasibility and accuracy of~     controlling a BCI using only their brain signals while seated in a tilting wheelchair.~   "
186522|NCT01123135|"~     This is a randomized, double blinded placebo controlled trial over a period of 3 months.~     Study subjects will be randomized into 2 groups: Those receiving drug (1gm of estrogen~     vaginal cream [EVC] at bed time 3 times a week), and those receiving placebo.~   "
186523|NCT01123122|"~     Islet transplants for those with type 1 diabetes have enabled many to initially eliminate~     insulin, however, only a fraction of the transplanted cells typically survive and the~     functioning of these decrease over time. As a result, most patients will eventually require~     some insulin. Currently, the cause of this poor survival and decrease in function is not~     understood; although previous research has demonstrated that even a slightly elevated level~     of blood glucose can impair islet function. This study will determine if strict blood glucose~     control at the time of islet transplantation, when the cells are the most fragile, will~     improve the survival and functioning of transplanted islet cells three months after~     transplantation.~   "
186524|NCT01123109|"~     The purpose of this research study is to measure the muscles that make up your anal sphincter~     (muscles that control bowel movements) by using ultrasound. The most common way for women to~     injure these muscles is through childbirth. Some physicians think about 30% of women~     delivering their first baby develop some anal sphincter damage, which may or may not lead to~     symptoms such as anal urgency or incontinence (involuntary loss of gas or stool). The purpose~     of the study is to measure muscles in normal women who have never given birth or had an~     injury to their anal sphincter.~   "
186525|NCT01123096|"~     The purpose of this research study is to identify if the cough stress test is equal to the~     24hour pad test in assessing stress urinary incontinence.~   "
186526|NCT01123083|"~     DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective~     is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in~     insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed~     meal-stimulated C-peptide.~      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3~     otelixizumab, 1/3 placebo). These study agents will be administered as an addition to~     insulin, diet, and other standard of care treatments.~   "
186527|NCT01123070|"~     The purpose of this study is to determine the safety and pharmacology of TL011 in patients~     with severe rheumatoid arthritis.~   "
186528|NCT01123057|"~     This is a hospital-based interventional prospective study. Patients with clinical keratoconus~     or LASIK keratectasia presenting to the Singapore National Eye Centre who meet the~     eligibility criteria are recruited for this study. The aim of the study is to assess the~     safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia~   "
186529|NCT01123044|"~     The aim of the study is to assess if transplantation of cultivated corneal epithelial stem~     cells could restore vision in patients with severe ocular surface disorder with a favourable~     safety profile that warrants further comparative study.~   "
186530|NCT01123031|"~     A bleeding peptic ulcer remains a serious medical problem with significant morbidity and~     mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality~     in patients with bleeding peptic ulcers and is now recommended as the first hemostatic~     modality for these patients.~      In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after~     endoscopic therapy has been endorsed in some studies. Laine and Javid et al found that oral~     PPI and IV PPI had a similar intragastric pH response in the past two years. Therefore,~     whether oral can replace IV in the management of peptic ulcer bleeding is the objective in~     this study.~      The investigators enrolled 130 patients with active bleeding or nonbleeding visible~     vessels（NBVV） in this study. They are randomly assigned as oral lansoprazole or IV nexium~     group. All patients receive successful endoscopic therapy with heater probe or hemoclip~     placement.~      In the lansoprazole group (N=65), 30 mg four times daily is given orally for three days.~     Thereafter, the patients receive 30 mg lansoprazole orally daily for two months. In the~     nexium group, 160 mg/day continuous infusion is given for three days. Thereafter, the~     patients receive 40 mg nexium orally daily for two months.~      The primary end point is recurrent bleeding before discharge and within 14 days. At day 14,~     volume of blood transfused, number of surgeries performed, and the mortality rates of the two~     groups are compared as well.~   "
186531|NCT01123018|"~     We hope to recruit participants into various clinical trials and research projects.~   "
186554|NCT01122719|"~     To evaluate the safety and efficacy of the Janus OPTIMA Tacrolimus-Eluting Stent (Optima TES,~     CID) for the treatment of de novo coronary lesions when associated with short-term (two~     months) dual antiplatelet (aspirin + clopidogrel) regimen.~   "
186539|NCT01122914|"~     Background:~        -  Severe atopic dermatitis, also known as eczema, is a chronic inflammatory skin condition~          that affects both children and adults and causes severe itching and skin redness.~          Current treatments of atopic dermatitis include topical creams and lotions, light~          therapy, and medications. However, the difficulty with long-term treatment for the~          chronic and severe nature of the disease requires more effective and better-tolerated~          therapeutic options.~        -  Anakinra is a drug that blocks a substance called interleukin-1 (IL-1), which may be~          important in causing the inflammation in atopic dermatitis. Researchers are interested~          in determining whether anakinra can be used to help treat atopic dermatitis. Anakinra~          has been approved by the Food and Drug Administration to treat rheumatoid arthritis in~          adults and children, but it has not been approved for use in adults or children with~          atopic dermatitis and is considered an experimental treatment in this study. In this~          study Anakinra will be administered as an injection under the skin every day for 3~          months~      Objectives:~      - To assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis~     in children.~      Eligibility:~      - Children between 10 and 18 years of age who have been diagnosed with severe atopic~     dermatitis that has not responded to standard treatment.~      Design:~        -  Initial Screening: Participants will have an initial screening visit with a complete~          physical examination and medical history, blood and urine tests, photographs of the skin~          ,skin biopsy, and other tests as required.~        -  Run-in Period: At the screening visit, participants will receive a diary card and will~          be asked to track their atopic dermatitis symptoms on standard treatment for 2 months.~        -  Start of Treatment: At the end of the 2 month Run-in period participants will return for~          an inpatient visit (2 days) to receive the initial dose of anakinra and will be watched~          for any side effects. During the inpatient visit, participants will have additional~          examinations and blood and urine tests, and will be instructed on how to administer the~          anakinra injections at home.~      Treatment Period: - Participants will return once a week for the first 2 weeks of treatment,~     at the end of the first month, and then once a month for the following 2 months, for a~     physical exam and blood tests. Participants will be asked to record symptoms related to their~     atopic dermatitis, anakinra administration and any side effects related to the anakinra on~     the diary card. The diary cards will be reviewed and collected at each visit.-~      End of Treatment Period: At the end of 3 months of treatment with anakinra, participants will~     again be asked to record symptoms related to their atopic dermatitis on the diary card.~     Participants will be seen once a month for 3 months for a physical exam, blood tests and~     review of the diary card. . The final study visit will take place at the end of the 3rd month~     and will include a physical exam, blood tests, photographs and skin biopsy.~   "
186540|NCT01122901|"~     This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor~     RO4929097 works in treating patients with recurrent or progressive glioblastoma.~     Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
186541|NCT01122888|"~     This clinical trial is studying how well giving cilengitide together with sunitinib malate~     works in treating patients with advanced solid tumors or glioblastoma multiforme. Cilengitide~     and sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor.~     Giving cilengitide together with sunitinib malate may kill more tumor cells. Studying samples~     of blood in the laboratory from patients receiving cilengitide and sunitinib malate may help~     doctors understand the effect of these drugs on biomarkers.~   "
186542|NCT01122875|"~     This is a multicenter, open-label, dose-escalation study of MFGR1877S in patients with~     relapsed or refractory t(4;14)-positive multiple myeloma.~   "
186543|NCT01122862|"~     A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth~   "
186544|NCT01122849|"~     The purpose of this exploratory study is to evaluate the subjective measures of congestion~     and sleep quality in subjects who suffer from chronic nasal congestion and report trouble~     with their sleep.~   "
186545|NCT01122836|"~     This study is designed to determine the most effective dose of massage for persons with~     chronic neck pain. This information is necessary before more definitive studies can be~     conducted.~   "
186546|NCT01122823|"~     The purpose of this study is to learn if Group Health members who participate in the online~     chronic disease self-management program will experience improved health outcomes, improved~     health care utilization, and lower costs.~   "
186547|NCT01122810|"~     Coronary vasculopathy remains the leading cause of decreased survival after the first year~     post-transplantation. It is mainly asymptomatic because of the denervation of the heart~     transplant. Currently, annual invasive coronary angiogram is performed to ensure the lack of~     coronary narrowing. But invasive coronary angiography caries risks of serious adverse events~     and some concern rise from its repetition in that population. Recent advance in coronary~     multidetector computed tomography (CT) may allow non invasive visualization of the coronary~     tree. But, it remains unknown if the encouraging data observed in native coronary artery~     analysis can be extrapolated to transplant heart recipients. Indeed, only very small sample~     size studies (20 patients) have been conducted in this particular setting. Thus, the~     investigators decide to assess the diagnostic accuracy of the 64-row CT and 256-row CT~     compared to the gold standard coronary angiogram in a larger sample size study. The practice~     aim of this study is to determine if the conventional invasive coronarography can be switched~     by the 64-row CT or the 256-row CT to assess coronary anatomy especially for the patient~     without any coronary artery disease (CAD) or those with CAD not suitable for percutaneous~     coronary intervention.~   "
186548|NCT01122797|"~     Increasing evidence attests the influence of multiple metabolic genetic risk factors in the~     progression of alcoholic liver disease. Deleterious pathways involved in metabolism such as~     lipid peroxidation and cytokines have been implicated in promoting inflammation leading to~     fibrosis increase and liver injury progression. The aim of this study was to assess the role~     of rs738409 single nucleotide polymorphism in the PNPLA3 gene in alcoholic liver disease~     patients.~   "
186549|NCT01122784|"~     Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at~     a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four~     parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts~     (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or~     Days 0, 56 and 121).~   "
186550|NCT01122771|"~     This protocol will evaluate the efficacy and safety of various combinations of the three~     drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard~     treatment with a total dose of 15mg/kg of AmBisome.~   "
186551|NCT01122758|"~     The research project CHAIN (COPD Assessment History in Spain): A Multidimensional Study on~     the Evolution of Chronic Obstructive Pulmonary Disease (COPD)is a multicentre, observational~     study conducted in several areas of Spain aimed to better define COPD natural history and its~     phenotypes~   "
186552|NCT01122745|"~     1. Rotator cuff have painful post surgery recovery.~        2. Single shot interscalene with oral analgesics may or may not be enough~        3. Continuous nerve block may be too much for the surgery~        4. The idea is to compare two techniques to see if the two techniques can improve patient~          pain control and satisfaction.~   "
186553|NCT01122732|"~     1. Interscalene continuous catheter is a very effective way of controlling pain in total~          shoulder arthroplasty. To ensure proper placement, nerve stimulating catheter is quite~          often used.~        2. Ultrasound can help proper placement of catheter without relying on nerve stimulation.~        3. The plan of the study is to compare two techniques head to head to see if they are~          equally effective or one is better than others.~   "
186555|NCT01122706|"~     Background: Excessive exposure to psychosocial stress can be a potent trigger for somatic~     diseases and psychological disorders, a cause for missing work, and eventually lead to high~     economic loss. Therefore, for health and economic reasons the assessment of effectiveness of~     stress preventive interventions is of high relevance. According to several clinical studies,~     Taiji, a Chinese form of mindful and gentle movements, can significantly reduce symptoms of~     somatic diseases and psychological disorders. Some recently conducted Taiji-studies with~     healthy subjects indicate a stress protective effect. However, the stress protective impact~     of Taiji regarding psychosocial stress has not yet been examined.~      Objective: To investigate the efficacy of a 12 week Taiji training as a stress prevention~     program by measuring psychosocial stress reactivity in a laboratory setting, as well as the~     subjective perception of stress and coping-resources in daily life of 70 healthy volunteers.~      Hypothesis: Healthy subjects attending a 12 week Taiji course (frequency: twice a week for~     1h) will show significantly reduced psychobiological reactivity, decreased stress perception~     and increased coping-resources on a standardized psychosocial stress test compared with~     healthy subject of the waiting list.~   "
186556|NCT01122693|"~     The use of ultrasound imaging techniques in regional anaesthesia is rapidly becoming an area~     of increasing interest. It represents one of the largest changes that the field of regional~     anaesthesia has seen. For the first time, the operator is able to view an image of the target~     nerve directly, guide the needle under real-time observation, navigate away from sensitive~     anatomy, and monitor the spread of local anaesthetic (LA).The key to successful regional~     anaesthesia is deposition of LA accurately around the nerve structures.~      In the past, electrical stimulation which relied on surface landmark identification, was used~     for this. However, landmark techniques have limitations; variations in anatomy and nerve~     physiology , as well as equipment accuracy have had an effect on success rates and~     complications.~      However, alongside the enthusiasm of ultrasound guidance in regional anaesthesia, there~     should be a degree of informed scepticism. The widespread use of the various techniques of~     ultrasound-guided regional blocks without adequate training raises the danger of malpractice~     and subsequent impaired outcome.~      Adequate education in the use of regional block techniques under ultrasound guidance is~     essential. Recent technical developments have achieved higher ultrasound frequencies and~     better image resolution, as well as better post-processing and user-friendliness.~      The purpose of this study is to determine whether new technical features such as reference~     images, higher ultrasound frequencies, better image resolution and smaller size and weight of~     the ultrasound probes may improve outcome (clinical benefits) and may show an increased~     efficacy and safety. And if the new technology of ultrasound images improves the training~     quality of trainees and novices in the art of ultrasound-guided blocks.~   "
186557|NCT01122680|"~     The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25~     mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium~     5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler~     in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top~     of maintenance therapy with an inhaled corticosteroid controller medication. It is a~     randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over~     design. Patients need to be still symptomatic, i. e. not fully controlled with their~     maintenance treatment.~   "
186558|NCT01122667|"~     This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in~     subjects with impaired renal function and healthy matched control subjects.~   "
186559|NCT01122654|"~     This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant~     formulas in healthy, term infants.~   "
186560|NCT01122641|"~     Animal models have demonstrated that incretins have a glucose-independent effect on vascular~     perfusion, and there is limited evidence that incretins may enhance endothelial function in~     healthy subjects. Currently DPP-4 inhibition increases levels of the endogenous incretin~     Glucagon-like Peptide 1 (GLP-1) and is licensed for the treatment of hyperglycaemia in type 2~     diabetes. They are positioned as third or even fourth line therapy after metformin,~     sulphonylureas ± glitazones, however recent analyses of cardiovascular outcomes in glitazones~     and sulphonylureas suggest at best they do not reduce cardiovascular endpoints, and may~     increase some outcomes. If the vascular benefits suggested in animal models are realised in~     humans this should see the DPP-4 inhibitors moved to second line and possibly 1st line.~      In order to realise the potential the investigators would like initially to demonstrate~     increases in vascular perfusion and function in a placebo controlled trial using accurate~     surrogates for vascular function in patients with insulin resistance and obesity.~      The investigators hypothesis is that by increasing incretin activity in insulin resistant~     states the investigators will lower capillary pressure and improve microvascular function,~     which will be accompanied by a reduction in macular thickness (by reducing macular oedema)~     and microalbuminuria, recognised surrogates for early diabetic retinopathy and renal failure~     respectively.~   "
186561|NCT01122628|"~     The surgical treatment of wrist fractures (distal radius bone) has been changed by the~     introduction of a new plate design, the locking plate. This results in improved fixation and~     stabilisation of the fracture fragments allowing early movement.~      This type of plate has been increasingly used throughout the world but questions have been~     raised regarding the potential complications of the surgery, particularly nerve and tendon~     injury. The Norfolk and Norwich Hospital has treated over 250 distal radial fractures with~     this type of plate. The investigators plan to recall these patients to asses their long term~     function, general satisfaction and radiological results.~   "
186562|NCT01122615|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of sunitinib and temsirolimus that can be given to patients with metastatic~     kidney cancer.~   "
186563|NCT01122602|"~     The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of~     fast release aspirin tablets, 650 mg (2 x 325 mg) compared to regular aspirin tablets, 650 mg~     (2 x 325 mg) and placebo in subjects with postsurgical dental pain.~   "
186564|NCT01122589|"~     The purpose of this study is to determine the extent to which an Intentional Behavioral~     Intervention will increase tobacco quit rates post release among incarcerated men and women.~   "
186565|NCT01122576|"~     The objective of this study is to evaluate the efficacy and subject satisfaction with three~     different FDA approved lenses for adults over 40 years of age who desire a reduction in~     spectacle dependence.~   "
186568|NCT01122537|"~     Meningitis is a rare complication following neurosurgical procedures and is associated with~     high morbidity and mortality. The aim of this study is to describe the clinical~     characteristics and microbiological characteristics in patients who develope meningitis~     following neurosurgical operations, and investigate the useful tips for the differential~     diagnosis of postneurosurgical meningitis.~   "
186569|NCT01122524|"~     The primary objective of this study is to determine the performance characteristics~     (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21)~     compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).~      Secondary objectives are to assess performance of the test to detect male gender (XY) and~     other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45,~     X)) compared to clinical fetal karyotype.~   "
186570|NCT01122511|"~     This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive~     therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of~     patients with choroidal neovascularization secondary to age-related macular degeneration~   "
186571|NCT01122498|"~     Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be~     consented, screened, and enrolled in the study if they meet all eligibility criteria. At the~     time of open surgical repair, subjects who are randomized to receive the test article in~     addition to the Standard of Care (SOC) will be hospitalized and have a single dose of~     BMP-655/ACS surgically implanted at the site of tendon attachment to bone. Subjects who are~     randomized to receive SOC alone will receive no test article. Following surgery, subjects~     will be prescribed a rehabilitation plan. Subjects will then complete 9 follow-up visits~     beginning 24 hours after surgery and continuing through 52 weeks.~   "
186572|NCT01122485|"~     The objective of this study was to explore the efficacy, dose-response and safety of PG201~     tablet in Korean patients with osteoarthritis.~   "
186573|NCT01122472|"~     This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to~     explore the effect of maintenance therapy with lenalidomide versus placebo on~     progression-free survival (PFS) in patients treated with R-CHOP responding to induction~     therapy~      For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for~     Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs~     73.6%), is considered clinically relevant.~   "
186574|NCT01122459|"~     Avoiding nausea and vomiting is one of the most important for patient comfort and~     satisfaction, and preventing unplanned overnight stays in hospital following surgery. Studies~     have shown that increased amounts of intravenous fluid during surgery prevent nausea and~     vomiting after operations. This effect lasted for up to 48 hours after the surgery. Other~     unpleasant side effects of dehydration that delay recovery including headaches and dizziness~     can be prevented with fluid treatment during the operation. It is unclear if this effect~     happens with all types of fluid. The investigators propose to examine the effect of 2 types~     of intravenous fluids on recovery from anaesthesia. Each group will be given a different~     fluid while using our usual anaesthetic technique. The investigators will ask questions about~     nausea and vomiting after surgery (primary outcomes), and other factors relating to patient~     comfort such as headache and dizziness (secondary outcomes)~   "
186575|NCT01122446|"~     A double-blind, randomized investigator-initiated study to determine the safety and the~     effect of Diamyd® on the progression to type 1 diabetes in children with multiple islet cell~     autoantibodies~      Eligible children are 4 years or older, have positive GAD-antibodies and at least one~     additional autoantibody and not yet diabetes.~      Objectives:~      DiAPREV-IT is the first prevention study with Diamyd®, where the drug is given before onset~     of type 1 diabetes.~      The primary objective is to demonstrate that Diamyd® is safe in children at risk for type 1~     diabetes.~      The secondary objective is to evaluate if Diamyd® may delay or stop the autoimmune process~     leading to clinical type 1 diabetes in children with ongoing persistent beta-cell~     autoimmunity as indicated by multiple positive islet cell autoantibodies.~   "
186576|NCT01122433|"~     The purpose of this study is to evaluate the C-MAC video laryngoscope in difficult airway~     situations.~   "
186577|NCT01122420|"~     The purpose of this study is to determine whether different types of online health tools can~     aid overweight individuals in reducing their weight and managing their cardiovascular risk~     factors in the context of an employee wellness program.~   "
186578|NCT01122407|"~     The overall goal of this proposal is to determine the autonomic and nitric oxide contribution~     in the pathogenesis of hypertension and insulin resistance in obese African American women.~     For this purpose we will use two non-FDA approved drugs:~      Trimethaphan IND# 63826 Approval date 12/20/2001 L-NMMA IND# 41735 Approval date 09/1993~   "
186579|NCT01122394|"~     Adults who have had a previous stroke or transient ischemic attack (TIA) remain at risk for~     having a second serious event, especially if they have uncontrolled blood pressure or~     cholesterol. However, many patients have difficulty following treatment recommendations for~     lowering blood pressure and cholesterol. The purpose of this research project is to evaluate~     the effect of 2 booster sessions of an educational counseling intervention on how well adults~     who have already participated in a 6-month clinical trial had a stroke or transient ischemic~     attack (TIA) are able to follow a treatment plan and control their blood pressure and~     cholesterol levels. We will also examine how effective this intervention is in improving~     adherence to diet, medication, and physical activity recommendations for adults who have had~     a prior stroke or TIA.~   "
186580|NCT01122381|"~     The purpose of this study is to determine whether ethosuximide works better than placebo in~     the prevention of episodic migraine among veterans.~   "
186581|NCT01122368|"~     Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will~     be treated early with micafungin or placebo to determine the incidence and time to~     confirmation of fungal infection.~   "
186582|NCT01122355|"~     The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg~     and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary~     end point is the percent change of apoB/A1 and the secondary end points are other lipid~     parameters and biomarkers.~   "
186827|NCT01119157|"~     This is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged > 18~     and < 60 years to evaluate the cellular and humoral immunogenicity as well as the~     reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including~     aluminium adjuvanted whole virus vaccine, split vaccine and subunit vaccine.~   "
186583|NCT01122342|"~     Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes~     thin and symptoms develop including vaginal itching, vaginal discomfort and dyspareunia.~     These can significantly affect women's comfort, sexuality and quality of life.~      Treatment for this condition includes estrogen given in pill form, commonly known as hormone~     replacement therapy and local estrogen treatments, such as vaginal estrogen creams and~     topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women~     with breast cancer. Some providers also feel that women who are taking aromatase inhibitors~     for their breast cancer should also not use local estrogens as several small studies suggest~     that these treatments might effect estrogen levels and thus might change how effective the~     aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there~     symptoms may not be well controlled with other treatments.~      The investigators hypothesize that a vaginal testosterone cream might be a safe and effective~     alternative treatment for these women. This small study is intended to test the hypothesis~     that testosterone cream will not increase estrogen (estradiol) levels and that it will~     improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and~     pain with intercourse.~      The investigators will enroll women in the trial who are taking an aromatase inhibitor and~     have the symptoms mentioned above. They will receive a testosterone cream which will be~     applied vaginally once a day for 28 days. If good results are found with a prespecified dose~     of testosterone, a lower dose will be tested in the next group of women enrolled.~   "
186584|NCT01122329|"~     This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for~     Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission~     tomography prior to and 90 minutes after consumption of Axona® at baseline and then again~     after 45 days of treatment. Cognitive testing will also be conducted at baseline and day 45.~   "
186585|NCT01122316|"~     The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will~     assess the use of the medication metformin to improve quality of life, exercise capacity, and~     improved outcomes with patients that have both heart failure and diabetes.~      If you participate in this study, you will receive the drug metformin for approximately 3~     months. During the study you will undergo comprehensive testing which includes blood draws,~     an echocardiogram, and an magnetic resonance imaging (MRI)(if you do not have a pacemaker or~     defibrillator). You will also fill out a questionnaire and keep a blood glucose log.~      You must be 18 years old to participate. The study drugs, study follow—up visits, and~     laboratory tests will be provided free of charge. Participants will be reimbursed up to $200~     for their time and travel expenses.~   "
186586|NCT01122303|"~     Autologous serum eye drops (ASE) have been becoming popular in treatment of severe dry eye~     for the past decade. One of the most beneficial properties of the ASE over artificial eye~     drops is the epitheliotropic capacity owing to the presence of growth factors and other~     proteins. There have been reports on alteration of serum growth factors in autoimmune~     diseases such as rheumatoid arthritis. Alteration in serum growth factors may lead to~     different therapeutic effect of ASE. We therefore would like to know if there are any~     alteration growth factors, epidermal growth factor (EGF), transforming growth factor-beta1~     (TGF-β1), transforming growth factor-beta2 (TGF-β2), and fibronectin, in ASE from~     Stevens-Johnson syndrome (SJS) patients with dry eye, which constitutes a major group of ASE~     usage in Siriraj Hospital, as compared with non-autoimmune dry eye. We also study stability~     of these factors following different storage conditions.~   "
186587|NCT01122290|"~     Background: Children's emotional eating is related to greater BMI and less healthy diet but~     little is known about the early development of this behavior.~      Objective: This study aimed to examine the relationships between preschool children's~     emotional eating and parental feeding practices using experimental manipulation of child mood~     and food intake in a laboratory setting.~      Design: 25 3-5 year old children and their mothers sat together and ate a standard meal to~     satiety. Mothers completed questionnaires about their feeding practices. Children were~     assigned to a control or negative mood condition. Children's consumption of snack foods in~     the absence of hunger was measured.~   "
186588|NCT01122277|"~     The purpose of this observational study is the prospective documentation and evaluation of~     the status quo of volume therapy in German intensive care units.~   "
186589|NCT01122264|"~     The purpose of this study is to investigate if treatment in erectile dysfunction with a~     long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer~     treatment adherence and better long term outcomes (over 24 weeks), compared with a~     short-acting drug (Sildenafil Citrate) taken as needed.~   "
186590|NCT01122251|"~     The purpose of this study is to evaluate the safety and efficacy of fixed combination of~     lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan~     alone in reducing blood pressure. The study will investigate the dose response relationship~     for the combinations and monotherapies.~   "
186591|NCT01122238|"~     At any given point in time, most smokers are not interested in making a serious quit attempt.~     Data suggest that 30% of smokers have no plans to quit, 30% plan to quit at some future date,~     30% plan to quit in the next 6 months, and about 10% plan to quit in the next month. While~     ~40% of smokers make a quit attempt each year, only about 4-6% of those achieve long-term~     success. This means that of the more than 60 million Americans who smoke, only 1 million are~     able to quit each year. If we could double the number of quit attempts and maintain~     comparable success rates, we could double the number of individuals who will benefit from~     living smoke free lives. These observations underscore the need to develop interventions that~     increase smokers' motivation or willingness to make quit attempts, and that also increase the~     rate of success among those who attempt to quit. The overall goal of this proposed experiment~     is to identify effective interventions aimed at increasing motivation for smoking cessation,~     increasing quit attempts, and increasing rates of cessation success. Interventions that will~     be tested include: use of nicotine gum, use of nicotine patches, motivational interviewing,~     and smoking reduction counseling. At minimum, all participants will complete surveys about~     their smoking behavior that might increase their motivation to eventually quitting smoking.~   "
186902|NCT01118156|"~     The purpose of this study is to evaluate whether a new standardized language for categorizing~     suicidal and self-injury related thoughts and behaviors can be readily adopted for use by~     mental health clinicians. Efforts also include developing a measure that can be used to help~     clinicians identify appropriate terms (e.g., behaviors) for specific patients.~   "
186592|NCT01122225|"~     Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests~     (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs.~     Neutrophil gelatinase-associated lipocalin (NGAL) may be able to predict ischemic AKI more~     effectively and faster than serum creatinine and urea levels.~      The purpose of this study is to take a blood sample from patients at admission and then at 24~     and 48 hours after to test their plasma for NGAL and compare the NGAL levels to their~     creatinine and urea levels. The investigators hypothesize that NGAL is an earlier marker to~     classify the kidney failure as acute tubular necrosis or pre-renal azotemia than creatinine~     and urea.~   "
186593|NCT01122212|"~     In Patients with minor head injury measurement of protein S100 will be introduced to the~     emergency departement as another tool to rule out intracerebral bleeding.~   "
186594|NCT01122199|"~     The purpose of this study is to test the safety of the combination of two drugs called RAD001~     and AMG479. This study will see what effects (good and bad) RAD001 and AMG479 have on cancer.~     This study will also find the highest doses of RAD001 and AMG479 that can be given without~     causing severe side effects.~   "
186595|NCT01122186|"~     The primary aim is to test an innovative 8-session intervention, based on Motivational~     Interviewing and Cognitive Behavioral Skills-Training for the co-occurrence of~     methamphetamine use and highly active antiretroviral therapy (HAART) non-adherence among~     methamphetamine using HIV+ MSM in NYC, compared to an 8-session educational (ED) condition.~     Participants in the intervention condition will report greater reductions in the number of~     days of methamphetamine use and viral load, and greater increases in CD4 counts and~     self-reported and objectively measured adherence than those in the education condition.~   "
186596|NCT01122173|"~     The purpose of this study is to assess the safety and performance of the Hansen Medical~     Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation~     catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats~     originating in the upper chambers of the heart).~   "
186597|NCT01122160|"~     Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and~     vegetables. The purpose of the study is to determine whether absorption of anthocyanins~     occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of~     an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from~     strawberries and blackberries.~   "
186598|NCT01122147|"~     Recurrent aphthous stomatitis is a difficult to treat and quite common chronic inflammatory~     disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's~     safety and effectiveness in treatment of aphthous stomatitis .~   "
186599|NCT01122134|"~     Intravenous artesunate is highly effective with rapid schizonticidal action and improved~     clinical outcome~   "
186600|NCT01122121|"~     The purpose of this study is to compare the efficacy and safety of combined radiotherapy and~     hormone therapy and hormone therapy alone in the treatment of clinically locally advanced~     prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).~   "
186601|NCT01122108|"~     The objective of this study is to compare the acceptability of Colesevelam HCl powder for~     oral suspension versus generic cholestyramine via the BASA scale, based upon an anticipated~     equivalent cholesterol lowering doses of each comparator drug.~   "
186602|NCT01122095|"~     Hypothesis 1: Patients with psoriasis will have clinical and laboratory assessments differing~     from control patients.~      Hypothesis 2: Patients with psoriasis will have laboratory alterations that correlate with~     other clinical characteristics of their psoriasis.~   "
186603|NCT01122082|"~     The purpose of this study is to observe the influence of carbohydrate-to-fat balance on~     liking, wanting and food consumption in humans.~      16 normal-weight men (age: 23 ± 3 y)had completed a randomized 4-condition crossover study.~     The sessions differed by the composition of the breakfast which was rich in carbohydrates~     (HCB), low in carbohydrates (LCB), rich in fat (HFB) and low in fat (LFB). The HCB and HFB~     contained 2072 kJ, while the LCB and LFB contained 565 kJ. Two hours and 20 min later, energy~     expenditure (EE) and respiratory quotient (RQ) were measured before olfactory liking for 4~     foods items and then ad libitum energy intake (EI) during a snack (sweet and fatty toast)~     were evaluated.~   "
186604|NCT01122069|"~     In patients with acute myocardial infarction, treatment logistics are primarily defined based~     upon ST segment shift in the electrocardiogram. While patients with ST elevation (STEMI) are~     forwarded to immediate coronary angiography and percutaneous coronary intervention, patients~     without ST elevation (NSTEMI) are initially medically treated and recommended coronary~     angiography within 48-72 hours.~      Early invasive treatment has been found cost-effective in intermediate and high-risk NSTEMI~     patients and current guidelines recommend use of the Thrombolysis in Myocardial Infarction~     (TIMI) risk score to identify patients who will benefit from early intervention due to high~     risk of new infraction and cardiovascular death. However, new research has suggested that~     TIMI risk score may not always identify patients with severe angiographic disease.~      The purpose of this study was to assess if contrast echocardiography could be used to~     identify NSTEMI patients with angiographically severe disease independent of their TIMI risk~     score.~   "
186605|NCT01122056|"~     The purpose of this study is to investigate the effects and tolerability of exercise on side~     effects of injectable disease modifying treatments in multiple sclerosis. The investigators~     main hypothesis is that controlled exercise is safe and can be well tolerated in patients~     with multiple sclerosis and it can improve disease modifying treatment related side effects~     such as fatigue.~   "
186617|NCT01121900|"~     The objective of this study was to compare the pharmacokinetic profiles of the test product,~     300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when~     administered as a single dose, and the reference product, 100 mg trazodone HCl~     immediate-release tablets (Apotex Corp), when administered three times daily. For this~     purpose the rate and extent of absorption of trazodone and formation of~     m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared~     under fasting conditions.~   "
186630|NCT01121731|"~     The general aim of this study is to determine if 3 MIU of IFN-α5 in monotherapy, and 1,5 MIU~     of IFN-α5 combined with 1,5 MIU of IFN- α2b, are safe dose levels as well as to investigate~     the antiviral efficacy and pharmacodynamics (PD) of such doses and drugs in~     treatment-experienced HCV patients with genotype 1 chronic infection, after 29 days of~     treatment. It is also intended to determine pharmacokinetics (PK) of the safe dose achieved~     of IFN-α5 in monotherapy.~   "
186606|NCT01122043|"~     The purpose of this study is to determine the clinical safety and efficacy of the EndoGlide~     as a donor insertion device in DSAEK surgery. The investigators hypotheses is that the~     Endoglide will cause less endothelial damage compared to the investigators previous technique~     of glide insertion but will have the same low complication rate as the previous device. Hence~     the investigators aim to evaluate the surgical efficacy of the EndoGlide to enable consistent~     double coiling of the donor lenticule in DSAEK surgery with minimal endothelial touch.~     Evaluate ease of insertion of the EndoGlide through a 4 to 4.5mm scleral tunnel wound.~     Evaluate ability of the EndoGlide to consistently effect complete wound sealing, so as to~     stabilize anterior chamber with an AC maintainer in position. Evaluate ease of donor~     pull-through from the EndoGlide chamber into the AC and to evaluate spontaneous uncoiling of~     the donor in the AC. Evaluate clinical efficacy and safety outcomes in EndoGlide assisted~     DSAEK surgery in study patients with corneal decompensation requiring DSAEK surgery, in terms~     of postoperative visual acuity, primary graft failure rate, donor dislocation rate,~     endothelial cell loss, and deturgescence of the host cornea and donor lenticule as measured~     by corneal thickness parameters with the Visante AS-OCT. The investigators will perfprm a~     prospective Phase II clinical trial using the EndoGlide for donor insertion in 100 corneal~     patients referred to the SNEC Corneal Clinics of the study investigators with moderate~     degrees of corneal decompensation from a variety of disorders which require DSAEK corneal~     transplantation surgery, with or without concurrent cataract surgery, to restore visual~     acuity.~   "
186607|NCT01122030|"~     The primary objective of the study is to evaluate the safety of single doses of oral~     naldemedine in adults physically dependent on opioids.~   "
186608|NCT01122017|"~     The present study was conducted among a group of Iranian patients suffering from varus knee~     in order to compare advantages and disadvantages of ROWHTO (Retro-Tubercle Opening Wedge High~     Tibial Osteotomy) technique when compared with previously described approaches of~     opening-wedge osteotomy.~   "
186609|NCT01122004|"~     The studied patients will be given randomly one of three following drugs1:Gabapentin2:~     Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be~     measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day~     (morning, evening) and then compared among three groups.~   "
186610|NCT01121991|"~     In-vitro fertilization (IVF) of human oocytes followed by the replacement of embryo in the~     uterine cavity has become a well established treatment for female infertility attributable to~     damaged fallopian tubes, endometriosis or unexplained causes where alternative forms of~     therapy have failed. The most commonly used protocols of follicular stimulation now employs~     follicle stimulating hormone (FSH) and long-acting agonists of gonadotropin releasing hormone~     (GnRH) to prevent the occurrence of a mid-cycle luteinizing hormone (LH) surge and to ensure~     the induction of well-synchronized larger cohort of ovarian follicles.~      The results of a number of studies have demonstrated that in the majority of clinical~     situations, FSH administration alone is sufficient to achieve successful follicular~     development. A study had shown that in subjects receiving recombinant human-follicle~     stimulating hormone (r-hFSH) and recombinant human-luteinizing hormone (r-hLH), pregnancy~     rates were similar in the younger and older age groups, however, in women receiving r-hFSH~     alone, there was a significant decline in pregnancy rates for women 35 and older. This~     particular study also went on to show that the subgroup of women 35 and older, may benefit~     from supplementary r-hLH. A number of studies have been conducted to assess the safety and~     efficacy of r-hLH administered concomitantly with r-hFSH in the presence of developing~     follicles to reduce the rate of growth of intermediate and small follicles while allowing the~     dominant follicle to continue to progress.~      This was a Phase III, open-label, multicentre study to evaluate safety and efficacy of~     addition of Recombinant Human-Luteinizing Hormone (Luveris) to a standard assisted~     reproductive technologies (ART) protocol.~   "
186611|NCT01121978|"~     This study is designed to identify the effect of current vitreous surgery for symptomatic~     macular tractional maculopathy.~      Characteristics of this study is as below~        1. Multicenter, prospective clinical trial. (early surgical intervention vs.surgical~          intervention when full-thickness macular hole formation or deterioration of visual~          acuity occurs)~        2. Non-randomized study (decision was made by patients after full explanation)~        3. After 1 year follow up, functional change(visual acuity)and anatomical change would be~          evaluated~   "
186612|NCT01121965|"~     This study is designed to verify hypothesis that early vitrectomy may prevent impending~     macular hole from progression to full-thickness macular hole.~   "
186613|NCT01121952|"~     The purpose of this trial was to explore the effects of chiropractic manipulation in patients~     with talo-crural joint dysfunction.~   "
186614|NCT01121939|"~     The purpose of this Phase II trial will be to define the activity of a VEGF inhibitor~      bevacizumab, HER1/HER2 inhibitor pertuzumab, and sandostatin for patients with~      advanced neuroendocrine cancers. In particular, the efficacy of bevacizumab and~      pertuzumab treatment is of great interest. The primary endpoint of this trial will be~      response rate. Toxicity and progression-free survival will be obtained and evaluated.~   "
186615|NCT01121926|"~     The purpose of this study was to compare the pharmacokinetic profiles at steady state of the~     test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing~     Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl~     immediate-release tablets (Apotex Corp.), when administered three times daily, for one week.~     For this purpose, the rate and extent of absorption of trazodone and formation of~     m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of~     each of the two formulations was compared.~   "
186616|NCT01121913|"~     The objectives of this study were:~        -  to compare the pharmacokinetic profiles of two prototype controlled-release (CR)~          trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC~          (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under~          fasting condition;~        -  to assess the controlled release properties of the two prototype formulations;~        -  to select a prototype formulation for further development;~        -  to validate the blood sampling schedule for future pivotal pharmacokinetic studies;~        -  to determine the appropriate sample size for pivotal studies based in the intra-subject~          variability.~   "
188811|NCT01093105|"~     The objective of this study is to evaluate the natural history of disease progression in~     infants with globoid cell leukodystrophy (GLD).~   "
186618|NCT01121887|"~     Aim: to assess the effect of adding Motivational Interviewing (MI) to the existing smoking~     cessation treatment protocol at the Swedish National Tobacco Quitline (SNTQ).~      Methods: Experienced counsellors at SNTQ either received further training in the standard~     treatment (ST) protocol (including Cognitive Behavioural Therapy (CBT)) or a comprehensive~     regime of training in MI. 1309 clients were randomized to either the ST group or the group~     with MI added to the treatment protocol. In order to ensure treatment integrity among~     counsellors, MI skill was assessed using the Motivational Interviewing Treatment Integrity~     Code (MITI).~   "
186619|NCT01121874|"~     Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who~     fail to respond to conservative treatment may benefit from surgery; however, controversy~     exists over the most effective surgical technique. A popular technique, ligament~     reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by~     reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.~      We believe that use of a suture fixation system to reconstruct the palmar oblique ligament,~     instead of harvesting a wrist tendon, may provide a superior repair. The objective of this~     study is to compare functional outcome measurements among patients who receive CMC~     arthroplasty using a suture fixation system (investigational group) to those who receive LRTI~     surgery (control group). We hypothesize that patients in the investigational group will~     demonstrate superior functionality, compared to patients in the control group.~   "
186620|NCT01121861|"~     Several methods have been developed to address and reduce preexisting astigmatism. The~     refractive results associated with the use of toric IOLs are likely to be more predictable.~     Other advantages of toric IOL include absence of need for any additional astigmatic~     correction procedure during cataract surgery, faster visual recovery as well as the~     reversibility of the procedure. There has not been any trial carried out to evaluate the~     results of toric IOL in either the investigators local population or in East Asia. Hence, the~     investigators set out to evaluate and compare the efficacy, safety, predictability and~     stability of the STAAR and Alcon toric IOL in Asian eyes.~   "
186621|NCT01121848|"~     Primary Objective:~      To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV)~     will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response~     Evaluation Criteria In Solid Tumors) criteria or death~      Secondary Objective:~      To evaluate other measures of tumor responses, safety, quality of life (QoL), and health~     utility assessment.~   "
186622|NCT01121835|"~     Primary Objective:~      To demonstrate the superiority of a strategy with insulin glargine in comparison with a~     strategy including the premixed insulin in term of percentage of patients reaching HbA1c~     (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience~     documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1~     mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle~     management and oral agents.~      Secondary Objectives:~      To assess the effect of insulin glargine in comparison with premixed insulin on :~        -  Evolution of HbA1c level during the treatment period Percentage of patients who reach~          the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia~          confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L)~        -  Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience~          documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L)~          >Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience~          documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L)~          >Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles~        -  Evolution of weight~        -  Hypoglycemia occurrence~        -  Dose of insulins~        -  Evolution of liver function~        -  Overall safety~   "
186623|NCT01121822|"~     The aim of this study is to evaluate the new formulation of the influenza vaccine for the~     2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the~     corresponding population and to check its compliance with the Committee for Proprietary~     Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96~      Objectives:~        -  To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split~          virion, inactivated) NH 2010-2011 formulation with the requirements of the Committee for~          Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both~          age groups~        -  To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011~          formulation in both age groups~   "
186624|NCT01121809|"~     Hypothesis: the intracellular concentrations of raltegravir (RAL) and etravirine (ETV)~     administrated as 800 and 400 mg once a day, respectively, are similar to those obtained with~     the standard doses of 400 and 200 mg/12h, respectively.~      Objective: To analyze the plasma and intracellular concentrations of RAL and ETV~     administrated as 800 and 400 mg once daily respectively compared with standard doses of 400~     and 200 mg/12h, respectively, and if they support its once daily administration.~   "
186625|NCT01121796|"~     Vitamin D has been shown to influence a multitude of systems. We intend to see whether~     different types of Vitamin D supplements have an effect on inflammatory bowel disease.~   "
186626|NCT01121783|"~     The purpose of the study is to determine whether the sweet taste receptors in the gut are~     involved in sensing sweet substances and controlling appetite and the amount we eat.~     Lactisole is a substance commonly used in food products to reduce the perceived sweetness of~     certain sugars and sweeteners. The aim of this study is to investigate whether the responses~     to a glucose solution, intragastrically administered to healthy male and female volunteers,~     is affected by the presence of lactisole in the gut. Understanding the mechanisms by which~     nutrients are initially detected in the gut and how they influence food intake is critical to~     the development of novel food products that could reduce food consumption.~   "
186627|NCT01121770|"~     The purpose of this study is to determine a preventative dose of study drug, Arixtra® for~     patients with kidney disease. We will measure the blood levels of Arixtra® in patients with~     kidney disease and develop guidelines for dosing.~   "
186628|NCT01121757|"~     The purpose of this study is to evaluate the response and safety in subjects receiving the~     drugs lenalidomide and azacitidine when each drug is given by itself and when the drugs are~     taken together. This study is open for patients with relapsed or refractory follicular or~     marginal zone lymphoma.~   "
186631|NCT01121718|"~     This study will try to define an appropriate dose of the investigational drug indocyanine~     green (ICG) in combination with near infrared (NIR) imaging to use for future studies.~      ICG is a dye which has been in use since the 50s, and is approved for testing liver function~     and measuring blood flow from the heart. It has been used in studies to map lymphatic~     pathways in lung and breast cancer and information from those studies suggest it may help~     identify lymph nodes associated with melanoma. ICG can be detected within the body using~     near-infrared light cameras.~      In this study the investigators are looking at how easily ICG can get to the first lymph node~     (sentinel lymph node [SLN]) associated with melanoma, whether the investigators can see the~     path of the ICG and the SLN using a near infrared camera, and what dose of ICG works the~     best. While the current method for SNL mapping, known as lymphoscintigraphy, is effective it~     does provide a small amount of radiation. This study will compare the investigators results~     to the standard procedure.~   "
186632|NCT01121705|"~     The study aimed at evaluating whether current 24 weeks length of combination treatment is~     appropriate or not for patients with HCV genotype 3 infection.~   "
186633|NCT01121692|"~     Couples who use alcohol and other drugs (AOD) in South Africa are at high risk for engaging~     in risky sex behavior within their relationships and with other sexual partners. In addition,~     high levels of gender-based violence (GBV) in the Cape Town area intersect with AOD abuse and~     sex behavior. All of these interconnections raise concern for the importance of HIV~     prevention strategies within or surrounding drinking venues, where many of these behaviors~     occur.~      The specific aims of this study are as follows:~      Aim 1. To characterize the types of drinking venues (e.g., licensure status, size, plumbing,~     type of alcohol provided), their immediate context (e.g., observed availability and use of~     other drugs, observable violence and sexual activity), and surrounding neighborhood~     characteristics (e.g., quality of streets, building structures, and availability of~     electricity and plumbing) in the sampled neighborhood blocks in several large Black/African~     and Coloured communities in Cape Town, South Africa.~      Aim 2. To refine through qualitative methods the proposed interventions in relation to~     skills-building to address gender-role expectations, sexual partnering, gender and power,~     violence, and environments where drinking and sexual risk behaviors occur.~      Aim 3. To conduct a randomized group trial to compare the relative efficacy of a~     comprehensive intervention (Condition 3: Enhanced Couples) to the gender-focused intervention~     (Condition 2: Gender) and to (Condition 1: Men's Control and Women's CoOp) on reducing~     alcohol and other drug (AOD) use, sexual risk behavior, and gender-based violence at 6 month~     follow-ups. Aim 4. To assess the mechanisms through which the intervention effects may occur~     (e.g., mediators involving self-efficacy and condom mastery, negotiation, and communication~     skills) and to identify groups for whom the interventions have the greatest effect (e.g.,~     partner characteristics such as race, gender, and age and neighborhood factors such as~     poverty) on study outcomes of AOD use, sexual risk, and gender-based violence.~   "
186634|NCT01121679|"~     Because of increased life expectancy and improved therapeutic methods in cardiology, the~     proportion of very old patients with cardiovascular disease increases. However, clinical~     practice in real life are still insufficiently known in this population. The~     recommendations still lack of studies specifically devoted to elderly or very elderly, an~     extrapolation of data based on evidence obtained in younger populations.~      This is a multicenter observational study during a day. On this day, all participating~     centers fill a questionnaire for each patient 80 years or older hospitalized in their~     service.~   "
186635|NCT01121666|"~     Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to~     the number of oocytes retrieved in women for assisted reproductive treatment.~   "
186636|NCT01121653|"~     Use lay language.~      The aim of this study is to evaluate on pain scores (neuropathic pain questionnaire and pain~     numeric scale) and on quality of life, the effect of oral magnesium intake on patients with~     neuropathic pain comparing with patients receiving placebo,. The study drug will be taken~     during 4 weeks.~   "
186637|NCT01121640|"~     The Novel Markers Trial will compare the safety, feasibility and effectiveness of two~     different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either~     a first or second line screen. This study is the next step in a larger research effort to~     develop a blood test that can be used as a screening method for the early detection of~     epithelial ovarian cancer.~   "
186638|NCT01121627|"~     Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system~     disease that influences not only the motor but also the cognitive and autonomic systems. The~     main cognitive impairment in individuals with PD is found in executive function (EF). EF is~     defined as a set of cognitive skills necessary for planning, monitoring and executing~     sequences of complex activities.~      The primary study hypothesis is that computer-based training aimed at improving executive~     function will have a beneficial effect on gait functions.~   "
186639|NCT01121614|"~     Ultrasonic cutting-coagulation devices (UCCD) are surgical instruments which use ultrasonic~     energy to cut through and coagulate tissue. An Ethicon version (trademarked Harmonic~     Scalpel and Ultracision) is used in a variety of surgical procedures. Its surgical~     performance has been directly compared with that of electrically powered diathermy~     instruments in animal and clinical trials. LOTUS is a company based in Ashburton, Devon,~     which has developed a UCCD that works in a slightly different way to the Harmonic Scalpel.~     There are also bipolar feedback diathermy instruments which use electrical energy to seal~     blood vessels, such as LigaSure. The aim of this project is to obtain data to design a fully~     powered trial to answer the research question: do LOTUS and Ethicon UCCDs and LigaSure~     bipolar device reliably seal and divide blood vessels? The investigators will also be~     examining the degree of collateral tissue damage caused by each instrument.~      Hypotheses~        -  LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure are equivalent at sealing and dividing~          mesenteric blood vessels.~        -  LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure cause equal amount of collateral~          damage when sealing and dividing blood vessels.~   "
186640|NCT01121601|"~     Study of phase II: Clinical study national, exploratory, multicentric, prospective,~     randomized, as a double blind man evaluating the effectiveness and the tolerance of the~     treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of~     operational adherences post.3 Study of phase III: Clinical study national, multicentric,~     prospective, randomized, controlled, as a double blind man comparing a group controls with a~     group of patients treated by a surgical gel of sealing containing polyethylene glycol in the~     prevention of hepatic adherences of novo post operational.~   "
186641|NCT01121588|"~     This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with~     tumors except non-small cell lung cancer that are positive for ALK.~   "
186737|NCT01120340|"~     The purpose of this study is to determine whether mesalamine is effective vs. placebo in the~     prevention of diverticulitis flares in a 24-months follow-up.~      The primary end-point of the study is the incidence of diverticulitis flares. Will be made a~     clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and~     altered intestinal motility.~   "
186642|NCT01121575|"~     Lung cancer tumors become resistant to the first generation epidermal growth factor receptor~     (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell~     signaling pathways: the cMET pathway and the EGFR pathway. Both resistance mechanisms can~     occur at the same time, in the same patient and even in the same tumor. This study combines a~     second generation EGFR inhibitor and a cMET inhibitor to block both these pathways in order~     to overcome resistance and treat this disease.~   "
186643|NCT01121562|"~     The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit~     response rate.~   "
186644|NCT01121549|"~     The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen,~     who either continued the same treatment or switched to Aromasin® for a total treatment period~     of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore~     appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in~     which it is used on a broader sample of patients and under the standard conditions of use as~     stipulated in the MA. This Non-Interventional study was designed to address these issues.~   "
186645|NCT01121536|"~     The primary objective of this study is to evaluate the safety and tolerability of long term~     (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in~     adults with bipolar I disorder.~   "
186646|NCT01121523|"~     The present study is an examination of cue-directed tactile stimulation (CTDS), administered~     by mothers and NICU nurses, on infant and maternal stress reactivity, infant immune system~     functioning, maternal parenting cognitions, and parenting competence.~   "
186647|NCT01121510|"~     The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and~     efficacy of the QuickClose design 9 closure device.~      patient undergoing a diagnostic or therapeutic angiogram procedure will be treated with the~     QuickClose Design 9. Patients will be monitored until 30 days after the procedure.~   "
186648|NCT01121497|"~     The purpose of this study is to determine whether the administration of physostigmine in~     combination with sedation for colonoscopy can minimize the cognitive decline at the time of~     hospital discharge~   "
186649|NCT01121484|"~     A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine~     succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and~     postmenopausal women with major depressive disorder~   "
186650|NCT01121471|"~     The purpose of this study is to determine the role of CLA as a complementary therapy to~     improve body composition, glucose tolerance, fasting plasma glucose and insulin, and~     hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).~   "
186651|NCT01121458|"~     Pulmonary arterial hypertension (PAH) is a rare blood vessel disorder of the lung in which~     the pressure in the pulmonary artery (PA) rises above normal levels and may become life~     threatening. PAH is frequently misdiagnosed and has often progressed to late stage by the~     time it is accurately diagnosed. PAH has been historically chronic and incurable with a poor~     survival rate. However, new treatments are available which have significantly improved~     prognosis. Right-heart catheterization (RHC) is the most accurate and useful test for PAH,~     and the only test that directly measures the pressure inside the PA. It is performed in all~     patients at least once, to get a definitive diagnosis of PAH.~      The most commonly used medication for this purpose is intravenous nitroprusside, however this~     medication in about 25-30% of patients is not well tolerated as it cause fast heart rates,~     which is not well tolerated by patients with pulmonary hypertension and/or heart failure. The~     CARVE study assesses the effect of Clevidipine, an ultra-short acting vasoselective calcium~     antagonist, on pulmonary vascular resistance (PVR) and its utility for pulmonary~     vasoreactivity testing during right heart catheterization (RHC) of patients with pulmonary~     hypertension (PAH).~   "
186652|NCT01121445|"~     Continuous positive airway pressure (CPAP) is the most commonly used treatment for~     obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in~     CPAP users. Nasal and sinus saline irrigation has been shown to improve these symptoms in~     individuals with chronic nasal congestion and sinusitis. This is an 8 week study that~     investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in~     patients using CPAP, improves quality of life and CPAP compliance.~   "
186653|NCT01121432|"~     Although mediastinal tuberculous lymphadenopathy is not rare in adults of such an~     abnormality. Isolated mediastinal without a parenchymal lung lesion in adults is unusual with~     the incidence of 0.25%-5.8%. It occurs most commonly in Asian and black people, and presents~     a diagnostic problem. The definite diagnosis requires microbiology or pathology study.~      Cervical mediastinoscopy remained the gold standard to sample the mediastnial lymph nodes,~     but this technique can access lymph node station 1-4, 7 only. EBUS-TBNA allows the~     mediastinal lymph nodes to be targeted in the areas accessible to cervical mediastinoscopy,~     as well as some hilar nodes (lymph node stations 2-4, 7, 10-12). Currently, the main~     indication of EBUS-TBNA is the mediastinal nodal staging of NSCLC after recent meta-analyses~     established the comparable sensitivity and specificity of nodal staging by EBUS-TBNA and~     cervical mediastinoscopy. Theoretically, mediastnial tuberculous lymphadenopathy could be~     diagnosed by the method of EBUS-TBNA. Douglas F. Johnson was the first doctor to report 2~     cases of mediastinal tuberculous lymphadenopathy diagnosed by EBUS-TBNA in 2009. There are~     currently no much data on the use of this technique in this field. The investigators plan to~     perform a prospective single-center study to investigate the diagnostic efficacy of~     mediastinal tuberculous lymphadenopathy by sampling the culprit nodes via EBUS-TBNA.~     Concomitant sputum specimen for acid-fast stain and mycobacterial culture were collected as~     well.~   "
186654|NCT01121419|"~     Neuroblastoma (NB), a common cancer of early childhood originating from primitive sympathetic~     neural precursors, is characterized by the remarkable heterogeneity of clinical behaviors~     from spontaneous regression to rapid progression and death. The current therapeutic options~     are developed according to the Children's Oncology Group (COG) risk stratification criteria~     based on clinical and biological factors, including tumor stage, MYCN status, age at~     diagnosis, histology, and ploidy status. 1-2 The treatment strategies ranging from~     observation alone to intensive multimodality therapy depends on the risk stratification of~     three subgroups of low, intermediate, and high risk of death. Despite a number of molecular~     and biologic factors has been identified to predict the prognosis, MYCN amplification, which~     occurring in roughly 20% of primary NB, is one of the most powerful prognostic factors.3 The~     co-opting neurotrophin pathways including the neurotrophin receptors (TrkA, TrkB, and TrkC)~     and their ligands (NGF, BDNF, and neurotrophin-3, respectively), which regulate the~     differentiation, apoptosis, and growth of neural cells, are also important molecules related~     to the prognosis of NB.4 However, a proportion of patients with MYCN nonamplified NB still~     presents clinically aggressive progression similar to those of MYCN amplified tumors,~     suggesting that other unfavorable molecules exist for the inferior survival.5-6 The IGF-II~     RNA-binding protein 3 (IMP3), also known as L532S or K homology domain-containing protein~     overexpressed in cancer (KOC), is a member of RNA-binding protein family which includes IMP1,~     IMP2, and IMP3. The IMPs are primarily expressed during early embryogenesis and have been~     implicated in various post-transcriptional functions, including mRNA localization, cell~     growth, and cell migration during early embryogenesis.7-8 The IMP3 orthologue Vg1-RBP in~     Xenopus has also been described to promote migration of neural crest cells.9 Recently, the~     IMP3 is considered an oncofetal protein by increasing proliferation and invasion in various~     cancers including pancreas, kidney, and lung cancers.10-14 The expression of IMP3 is,~     however, low or undetectable in adjacent benign tissues.13 These lines of evidence indicate~     that IMP3 is capable of a potential biomarker to predict cancer progression and metastasis,~     and may serve as a target molecule for cancer therapy.14~      oligonucleotide microarray is a powerful tool to do a genome-wide screening of candidate~     genes related to cancer prognosis.15 In this study, 22 primary NB tumors were subjected to~     oligonucleotide microarray analysis. Among the differentially expressed genes according to~     the patients' prognosis, IMP3 showed an especially high expression level in NB tumors~     carrying unfavorable prognosis. Further evaluation of IMP3 expression in a large sample size~     demonstrated that IMP3 expression could predict an unfavorable prognosis of NB patients~     independent of other biomarkers. Targeting of IMP3 expression in a NB cell line did suppress~     cell invasion ability, suggesting that IMP3 could not only be a prognostic factor, but also~     be a potential therapeutic target of NB.~   "
186686|NCT01121003|"~     8 healthy male volunteers will be studied each on 3 occasions, ie~        -  after 4 days on a weight maintenance diet containing 5% simple sugars + low physical~          activity~        -  after 4 days on a weight maintenance diet containing 30% fructose + low physical~          activity~        -  after 4 days on a weight maintenance diet containing 30% fructose + high physical~          activity At the end of each of these 3 periods, fructose induced hepatic de novo~          lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load)~          and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol)~          will be measured~   "
193257|NCT01033981|"~     Primary Hypothesis: The therapy with Sunitinib represents better cost-effectiveness than~     IFN-α in first-line treatment for metastatic Renal Cell Carcinoma (mRCC) in Central America~     and Caribbean countries~   "
186655|NCT01121406|"~     This is an international, randomized phase II trial. The aim is to assess the efficacy and~     the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent~     third and fourth lines platinum resistant/refractory ovarian cancer.~      100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50~     patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be~     continued until disease progression or unacceptable toxicity. Primary endpoint: disease~     control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version~     1.1.~      Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour~     response, biological progression free survival assessed by serum CA 125 according to~     Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease~     symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms~     questionnaires, pharmacokinetics of BI 6727.~      Others endpoints: biomarkers and pharmacogenetics analysis (optional)~   "
186656|NCT01121393|"~     To investigate the efficacy and safety of BIBW 2992 compared to standard first-line~     chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR~     activating mutation~   "
186657|NCT01121380|"~     The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021~     in healthy volunteers. Subsequent clinical studies will be designed to test the safety and~     efficacy of BL-1021 in patients with neuropathic pain based on data obtained from the~     proposal trial described below.~   "
186658|NCT01121367|"~     This study is to evaluate the expression of biological markers in induced sputum and~     peripheral blood T lymphocytes of patients with combined pulmonary fibrosis and emphysema~     (CPFE). The features of CPFE would be observed, including pulmonary function tests and~     fractional exhaled nitric oxide （FENO）.~   "
186659|NCT01121354|"~     The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g~     for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin~     1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult~     subjects for 11 days of administration.~   "
186660|NCT01121341|"~     The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective~     randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic~     open CO2 harvesting system versus conventional vein harvesting.~   "
186661|NCT01121328|"~     This is a pilot study to test feasibility of collection, preparation and infusion of a baby's~     own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born~     premature <35 weeks of gestation.~   "
186662|NCT01121315|"~     To describe the type II diabetes population in primary care with special reference to~     treatment, other diseases and mortality during the last decade. To test the hypothesis that~     the type or combination of per oral glucose lowering drugs have different effects on the risk~     of cardiovascular disease and diabetic complications.~   "
186663|NCT01121302|"~     1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after~          single oral doses.~        2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how~          the study drug enters and leaves your body and how your body acts on the study drug) of~          AZD5213 in your blood and urine.~      One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of~     AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and~     then return to the clinic to receive AZD5213 after eating a high fat breakfast.~   "
186664|NCT01121289|"~     This trial is conducted in Europe. The aim of this trial is to investigate the absorption and~     effect in the body of NN1218 in subjects with type 1 diabetes.~   "
186665|NCT01121276|"~     This trial is conducted in Europe and in the United States of America (USA). The aim of this~     trial is to investigate the absorption and effect in the body of NN1218 in subjects with type~     1 and type 2 diabetes.~   "
186666|NCT01121263|"~     The purpose of the study is to get a better understanding of patients who have multi-vessel~     coronary artery disease (blockages in more than one vessel bringing blood to the heart) and~     have either Hybrid Coronary Revascularization [HCR] (combination of surgery and catheter~     procedures to open up clogged heart arteries) or Percutaneous Coronary Intervention [PCI]~     (catheter procedures to open up clogged heart arteries). Participation in the study will last~     up to 21 months after a patient's heart procedure(s). The study collects information about~     the medical care patients receive during their planned procedure(s) and how well they do~     following the procedure(s). No new testing or procedures will be done. Patients will receive~     only the tests or procedures their doctor already has planned for them. The information~     collected should help to plan the design of a pivotal comparative effectiveness study of~     hybrid revascularization.~   "
186667|NCT01121250|"~     This 12-month study is for spouses or significant others of service members who have returned~     from Afghanistan or Iraq. This study will determine if participating in a telephone~     discussion group, offering education, skills building, and support, will help increase~     post-deployment adjustment. There will be 225 spouses recruited for this study.~   "
186668|NCT01121237|"~     MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level~     factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin~     alfa in Stage 5 CKD patients requiring haemodialysis.~   "
186687|NCT01120990|"~     Assessment of the accuracy of a Blood Pressure Measuring Device with a digital~     display-column, NISSEI DM 3000, according to an adaptation of the European Society of~     Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure~     Measuring Devices in Adults.~   "
186688|NCT01120977|"~     The treatment of Growth Hormone deficiency (GHD) patients with GH, often induce fluid~     retention; this effect is dose dependent and temporary. The symptoms are swelling of soft~     tissue and joint stiffness. The objective of this study is to create bioelectric~     impedance/arm muscle area (BIA/AMA) reference data, as a measurement of hydration status, of~     healthy persons of both genders in the age 20-70 years.~   "
186705|NCT01120756|"~     Some of the most common and disabling consequences of brain injury are deficits in cognition,~     such as difficulty with sustained attention, memory, organization, and goal management. The~     long-term goal of this research program is to develop and test novel neuroscience-based~     cognitive assessment tools and interventions for improving attentional regulation and related~     executive function brain processes involved in goal-directed behavior.~   "
186669|NCT01121224|"~     Patients who have undergone coronary bypass surgery have had a vein removed from the leg and~     implanted in the chest to bypass blockages in the coronary arteries. These veins are called~     saphenous vein grafts or SVGs. SVGs often develop blockages that can cause chest pain and~     heart attacks. SVG blockages can be opened by using small balloons and stents (metal coils~     that keep the artery open). Two types of stents are currently used: bare metal stents (BMS)~     and drug-eluting stents (DES). Both BMS and DES are made of metal. DES are also coated with a~     drug that releases into the wall of the blood vessel to prevent scar tissue from forming and~     re-narrowing the vessel. Both stents have advantages and disadvantages: DES require taking~     special blood thinners (called thienopyridines, such as clopidogrel or prasugrel) longer than~     bare metal stent and could have more bleeding but are also less likely to renarrow. Both BMS~     and DES are routinely being used in SVGs, but it is not known which one is better. Neither~     bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in~     SVGs. The purpose of CSP#571 is to compare the outcomes after DES vs. BMS use in SVGs.~      In CSP#571 patients who need stenting of SVG blockages will be randomized to receive DES or~     BMS in a 1:1 ratio. Per standard practice, patients will receive 12 months of an open label~     thienopyridine if they have acute coronary syndrome (ACS), or if they have another clinical~     reason for needing the medication. Patients without ACS who receive DES also need to take 12~     months of a thienopyridine whether or not they are in the study, but non-ACS patients who~     receive a BMS do not. In order to make sure patients do not know which stent they received,~     non-ACS patients who received BMS will receive 1 month of open label thienopyridine followed~     by 11 months of blinded placebo, while those who received DES will receive 1 month of open~     label thienopyridine followed by 11 months of blinded clopidogrel, which is a thienopyridine.~      All study patients will be followed in the clinic for at least 1 year after their stenting~     procedure to see if there is a difference in the rate of cardiac death, heart attack, or any~     procedure that is required in order to increase the flow of blood to and from the heart~     between the BMS and DES groups.~   "
186670|NCT01121211|"~     The investigators are investigating whether a hormone that is naturally produced by the human~     body, called testosterone, can help improve weight, disordered eating, depression, and~     anxiety. The investigators hypothesize that testosterone will be a novel and effective~     endocrine-targeted therapy for patients with anorexia nervosa.~   "
186671|NCT01121198|"~     This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of~     ASP1941 in healthy adult male subjects.~   "
186672|NCT01121185|"~     The purpose of this study is to determine whether a human monoclonal antibody against~     Hepatitis C (MBL-HCV1) is effective in preventing detectable levels of Hepatitis C virus in~     patients undergoing liver transplantation due to chronic HCV infection. The study will also~     determine if MBL-HCV1 is effective in delaying or reducing the amount of detectable HCV in~     patients after transplant.~   "
186673|NCT01121172|"~     The aim of this study is to investigate serum apelin levels as well as their possible~     association with G212A polymorphism of the apelin receptor in obese children and adolescents.~      So far apelin has been reported to be involved in the pathophysiology of various heart~     diseases such as cardiomyopathies and heart failure. According to recent reports in adults~     apelin seems to be associated with impaired glucose metabolism, particularly in newly~     diagnosed diabetes type 2 patients. Obesity is associated with insulin resistance and~     compensatory hyperinsulinemia leading to diabetes mellitus type 2 even in youngsters. The~     researchers will try to investigate the role of this new adipokine in order to early detect~     and to prevent similar entities in childhood obesity.~   "
186674|NCT01121159|"~     Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is~     better with preoperatively preformed orbital implants than with non-preformed orbital~     implants.~   "
186675|NCT01121146|"~     The purpose of the study is to determine whether crosslinked Marathon and standard Enduron~     polyethylene liners show differences in bone loss around the hip implant.~   "
186676|NCT01121133|"~     This is an open-label, single or multiple center study to determine the interaction of~     rifampin with navitoclax (ABT-263) in approximately 12 subjects with cancer.~   "
186677|NCT01121120|"~     The purpose of this study is to determine the safety and effectiveness of TXA127 in~     accelerating the time it takes for patients to recover their platelet counts following a~     Autologous Peripheral Blood Stem Cell transplant.~   "
186678|NCT01121107|"~     The purpose of this clinical study is to evaluate the safety and clinical effectiveness of~     use of a physician-directed, patient self-management system, guided by left atrial pressure~     measurements, for use in patients with heart failure. The system allows patients to adjust~     their HF medications daily based on a physician-directed prescription plan and their current~     HF status, similar to the manner in which diabetes patients manage their insulin therapy. The~     goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart~     failure (HF) and hospitalizations in patients who are managed with the left atrial pressure~     (LAP) management system (treatment group) versus those who receive only the current standard~     of care (control group).~   "
186679|NCT01121094|"~     The purpose of this study is to prospectively evaluated the T2* values of normal feti.A~     standardized scale of T2* values for fetal and neonatal iron organ overload have yet to be~     reported or devised.~   "
186680|NCT01121081|"~     This is a Randomized, Double-Blind, , Placebo Controlled, 18 Week Study To Evaluate the~     Efficacy of adjuvant 9-cis-β-Carotene Rich powder of the Alga Dunaliella bardawil in Subjects~     With Plaque type Psoriasis treated by Narrow Band UVB therapy.~   "
186681|NCT01121068|"~     Interferon gamma releasing assay(IGRA) is useful to diagnose latent tuberculosis.~     However,IGRA responses could show within-subject variability. We wanted to determine~     long-term IGRA variability in health-care workers who continuously expose to tuberculosis~     patients.~   "
186682|NCT01121055|"~     Many patients undergoing flexible bronchoscopy (FB) experience anxiety and discomfort during~     the procedure. The investigators want to evaluate whether an additional Lorazepam~     premedication would improve patient satisfaction for FB.~   "
186683|NCT01121042|"~     The aim of this study is to evaluate the overall effectiveness of Ondansetron as an~     adjunctive or add-on medication in the treatment of Schizophrenia. This study is a double~     blind, placebo-controlled, randomised, 12 week trial.~   "
186684|NCT01121029|"~     The purpose of this study is to determine if autologous nonmyeloablative hematopoietic stem~     cell transplantation is able to induce prolonged and significant increases of C-peptide~     levels associated with absence of or reduction of daily insulin.~   "
186685|NCT01121016|"~     Hypothesis: Add-on therapy with oral montelukast (Mon) to inhaled budesonide (BUD) may~     achieve better control of cough caused by nonasthmatic eosinophilic bronchitis (NAEB) with~     faster reduction of airway eosinophilia.~      Objective: To evaluate the efficacy of add-on therapy with Mon to inhaled corticosteroids~     (ICS) in the treatment of adult patients with chronic/subacute cough caused by NAEB diagnosed~     in outpatient setting. Primary endpoint：cough severity rated as cough visual analogue score~     (VAS)1 and eosinophil count in induced sputum during 4-week BUD monotherapy or Mon adjunct~     therapy.~   "
186689|NCT01120964|"~     This clinical trial will determine the safety and effectiveness of intravenous L-citrulline~     in children undergoing cardiopulmonary bypass during heart surgery. Participants will be~     randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in~     it).~      Citrulline is a protein building block in the body that can convert into another substance,~     nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in~     the lungs can be an important surgical problem; it may also lead to problems following~     surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased~     time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The~     hypothesis of this study is that perioperative supplementation with intravenous citrulline~     will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the~     postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical~     ventilation.~      The objective of this study is to determine in a randomized placebo controlled phase IB~     multicenter clinical trial if a revised protocol of intravenous L-citrulline delivery given~     perioperatively achieves a plasma citrulline level of > 100 umol/L in children undergoing~     surgical repair of an atrial septal defect,ventricular septal defect or an atrioventricular~     septal defect.~   "
186690|NCT01120951|"~     The study aims to to establish whether or not measurement of respiratory rate taken using the~     Anaxsys Technology Ltd Respiratory Counter (R8 Counter) are equivalent to manual respiratory~     rate counting methods in patients receiving oxygen via a face mask.~   "
186691|NCT01120938|"~     Sudden infant death syndrome (SIDS) is the leading cause of death among infants between 1~     month and 1 year of age in the developed world. SIDS continues to be a phenomenon of unknown~     cause. The best approach to for prevention in high risk infants is unclear. Several~     substantial lines of evidence indicate that pacifiers have a protective effect on the~     incidence of SIDS. These studies were significantly powered and the results were consistent~     world-wide. The explanation for the protective effects of pacifiers on SIDS prevalence is~     unclear. A recent case report from New Zealand showed by means of nasopharyngeal films of a~     baby with and without a pacifier the possibility that sucking on a pacifier is associated~     with a forward movement of the tongue with enlargement of the upper airways' cross sectional~     area. Indeed, this hypothesis was originally postulated 30 years ago by Cozzi et al.~      Working hypothesis and aims: Our hypothesis is that since the upper respiratory tract is that~     portion of the airway that imposes the greatest resistance to ventilation, sucking on a~     pacifier results in upper airway dilatation, thus greatly reducing upper airway obstruction~     and improving ventilation at a stage when infants are virtually obligate nasal breathers. It~     should be stressed that airway resistance is proportional to the 3rd power of the radius of~     the airway, thus even a relatively small increase in airway diameter may have a profound~     effect on airway resistance and respiratory mechanical work of breathing! In young infants~     and those with underdeveloped respiratory center drive, this decrease in the work of~     breathing could certainly be sufficient to minimize the risk of SIDS as described above.Thus,~     the aim of this study is to demonstrate the effect of sucking on a pacifier on upper airway~     patency.~   "
186692|NCT01120925|"~     Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver~     transplantation is the sole effective therapy available to these patients. However, limited~     number of donors, post surgical complications, immunological rejection, and financial~     consideration are it`s crucial problems. The plasticity of stem cells in bone marrow (BM) to~     differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have~     applied BMC injection to induce regeneration of myocardium and blood vessels. In this study,~     the investigators will study safety and feasibility of twice transplantation of Autologous~     bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through~     the portal vein in patients with decompensate cirrhosis.~   "
186693|NCT01120912|"~     The study will be a non-randomized, open label, single dose, single blind, placebo control,~     single center, single arm study in Type I diabetes patients. The study will include single~     dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and~     activity.~   "
186694|NCT01120899|"~     The objective of this study is to investigate the safety and efficacy of minocycline as a~     microglia inhibitor in individuals with diabetic macular edema (DME).~   "
186695|NCT01120886|"~     This is a prospective observational study to examine the incidence of cardiac ion~     channelopathies in unexplained still births.~   "
186696|NCT01120873|"~     To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese~     subjects with metabolic syndrome.~   "
186697|NCT01120860|"~     The primary purpose of this study is to apply state-of-the-art Magnetic Resonance Imaging~     (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) techniques to measure changes over~     time in the brain.~   "
186698|NCT01120847|"~     The current research program aims to study how sleep disordered breathing, age and genetics~     affect memory in older adult veterans with Posttraumatic Stress Disorder (PTSD).~      The study will help researchers and clinicians better understand the relationship among PTSD,~     sleep disordered breathing, genetics and memory function.~   "
186699|NCT01120834|"~     This will be a phase I/II study of 5-azacitidine in combination with vorinostat in patients~     with relapsed or refractory DLBCL. Combination therapy with methyltransferase inhibitors and~     histone deacetylase inhibitors is highly synergistic in DLBCL cells, and both classes of~     drugs can also synergize powerfully with standard anti-lymphoma chemotheraputics such as~     doxorubicin in pre-clinical studies. We hypothesize that azacytidine + vorinostat combination~     therapy will be safe and effective in selected patients with relapsed or refractory DLBCL. We~     also hypothesize that patients demonstrating objective responses to this combination therapy~     display specific epigenetic signatures, and that a biomarker or gene classifier can be~     generated which will identify those patients likely to respond.~   "
186700|NCT01120821|"~     The purpose of this research study is to evaluate the safety and effectiveness of patients~     with Polycythemia Vera treated with Gleevec.~   "
186701|NCT01120808|"~     Blisters are a very common complaint in both the general population and also the athlete.~     This study's aim is to determine whether applying paper tape (an inexpensive and common~     component of most foot care kits) to the foot of endurance runners prevents the frequency and~     severity of friction blisters.~   "
193258|NCT01033968|"~     The purpose of this study is to compare the pain perception at laser treatment of peripheral~     retinal degenerations with green and infrared wavelengths.~   "
186706|NCT01120743|"~     The primary goal of this project is to identify the source of cytokines that are released~     into circulation during graft reperfusion. Seventeen patients scheduled to have adult~     cadaveric liver transplantation at the Milton S. Hershey Medical Center were contacted as~     prospective participants. Blood samples were obtained from the radial artery, the portal~     vein, and from the graft irrigation. The level of pro-inflammatory cytokines was verified and~     compared with the amount of catecholamines used to maintain hemodynamic stability.~   "
186707|NCT01120730|"~     HES 200/0.5 10% is equal to ringers lactat solution.~   "
186708|NCT01120717|"~     The study is designed to provide long-term safety data for QVA149 in patients with moderate~     to severe chronic obstructive pulmonary disease (COPD).~   "
186709|NCT01120704|"~     Many smokers fail to take their smoking cessation medication as recommended. This research is~     designed to identify treatments that improve the use of cessation medications and to~     determine whether an increase in medication use results in increased cessation success. This~     research will also identify treatments that help people stay quit after a quit attempt and~     will pioneer more efficient research methods.~   "
186710|NCT01120691|"~     This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in~     patients with severe to very severe COPD.~   "
186711|NCT01120678|"~     The purpose of this study is to determine whether analysis of specific serum biomarkers will~     improve the diagnosis of late onset neonatal sepsis and to determine the correlation between~     plasma levels of specific cytokines and bacteremia in NICU patients >3 days of age.~   "
186712|NCT01120665|"~     This study will investigate the isolated and the associated effect of estrogen therapy and~     physical exercise in the function, regulation and cardiovascular risk markers of 60~     postmenopausal women, (45 - 60 years old). The volunteers will be randomaized into two~     groups: estrogen therapy (estradiol valerate 1 mg/day oraly) and placebo. The two groups will~     be randomaized into two subgroups: exercise group (aerobic trainning,cicle-ergometre, 50~     minutes, 3 x week) and sedentary group. At 0, 6 and 12 months the volunteers will be submited~     to: clinical analise, cardiorespiratory analise (ergoepirometric test), quality of life~     questionare (Short Form-36 [SF-36]), ambulatory blood pressure monitoring during 24 hours and~     to 2 experimental sessions where the cardiovascular responses to insulin action~     (euglicemic/hiperinsulinemic clamp) and to physical and mental stress (microneurography) will~     be accessed. Besides these, the volunteers of the sedentary group will be submited to an~     extra session at 6 months of study evaluate the physiological answer to insulin infusion~     after an acute session of exercise.~   "
186713|NCT01120652|"~     The purpose of this randomized controlled trial is to evaluate the efficacy of a Mind-Body~     Skills Training intervention for improving mental and physical health in patients with~     Systemic Lupus Erythematosus (SLE) who have comorbid depressive symptoms.~   "
186714|NCT01120639|"~     The purpose of this study is to investigate the safety and effectiveness of a combination~     treatment for glioblastoma multiforme utilizing radiotherapy with the FDA approved~     chemotherapy drug temozolomide~   "
186715|NCT01120626|"~     Fragile X syndrome (FraX) is the most common known heritable cause of human intellectual~     disability. Though recent research has revealed much about the genetic and neurobiological~     bases of FraX, knowledge about specific and effective treatments for affected individuals is~     lacking. Based on information from both human and animal studies, one cause of intellectual~     disability in FraX may be related to deficits in a particular brain neurotransmitter system~     (the cholinergic system). Thus, the investigators propose to use a specific medication,~     donepezil, to augment cholinergic system in adolescents affected by FraX. If found to be~     effective, the knowledge generated by this research may also be relevant to other~     developmental disorders that share common disease pathways with FraX.~   "
186716|NCT01120613|"~     Hypertension (HTN) affects up to 75% of kidney transplant recipients and is associated with~     premature death. Nocturnal HTN is a common complication of ongoing essential HTN or a~     secondary cause of HTN. Both the non dipping of systolic blood pressure (SBP) at night time~     and the reverse dipping is associated with increased target organ damage and adverse~     cardiovascular outcomes and possibly allograft survival. Treatment of Nocturnal HTN is~     critical. Chronotherapy has been shown to be effective in halting progression in patients~     with diabetic nephropathy and chronic kidney disease. There is not enough data on prevalence~     and management of nocturnal HTN in transplant patients, which is the object of this study.~   "
186717|NCT01120600|"~     The purpose of this study is to test the hypothesis that treatment with odanacatib will~     result in increased bone mineral density (BMD) compared to treatment with placebo. This study~     will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.~   "
186718|NCT01120587|"~     This study has as objective to characterize the start of pharyngeal phase of swallowing, in~     the various food consistencies and volumes, with and without the influence of verbal orders,~     observed on videofluoroscopy of deglutition.~   "
186719|NCT01120574|"~     The objective of this study is to evaluate the clinical benefits of home mechanical~     ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure~     (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen~     administration.~      We will include clinically stable COPD patients with hypercapnic CRF who develop a nocturnal~     hypercapnic response to oxygen (PaCO2 increase on awakening, at night with oxygen, >10 mmHg~     respect to PaCO2 breathing room air and awake). Obstructive sleep apnoea syndrome (OSAS) will~     previously have been excluded.~      Patients will be admitted to the Pneumology ward where a nocturnal pulsioxymetry breathing~     oxygen therapy will be performed. Arterial blood gas samples will be taken at awakening~     (7AM).~      Patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment~     groups:~        -  Oxygen therapy group~        -  Home mechanical ventilation plus oxygen therapy group Home mechanical ventilation will~          be performed with a bilevel pressure ventilator. Functional respiratory variables as~          well as quality of life and sleep at onset and after 6 months treatment will be~          compared.~      The principal outcome will be the evolution of arterial blood gases (PaCO2) between the two~     groups.~   "
186720|NCT01120561|"~     This is a multicenter, open-label, single-arm, expanded access study designed to provide~     T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to~     evaluate the safety and efficacy of T-DM1 administered by intravenous (IV) infusion.~   "
186721|NCT01120548|"~     Sleep disordered breathing (SDB) is a frequent comorbidity for heart failure patients. Its~     prevalence varies according to the seriousness of the condition of the patients, but it is~     present in approximately 50% of patients. Screening patients for SDB and managing them by~     providing adapted ventilation therapy should improve their quality of life or even their~     prognosis. Moreover, SDB lowers nocturnal cardiovascular recovery abilities and leads to an~     increase in fatigability and, as a result, exercise intolerance in patients with heart~     failure. Physical training as part of a cardiac rehabilitation programme provides many~     benefits, including improving patients' exercise capacities. Our hypothesis is that adapted~     sleep disordered breathing therapy during rehabilitation will lead to an improvement in~     rehabilitation results.~   "
186722|NCT01120535|"~     The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and~     effective in preventing pulmonary embolism.~   "
186723|NCT01120522|"~     The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and~     effective in preventing pulmonary embolism.~   "
186724|NCT01120509|"~     The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and~     effective in preventing pulmonary embolism.~   "
186725|NCT01120496|"~     The purpose of this study is planned to investigate whether frequently inhaled hypertonic~     saline (HS) can relieve symptoms and signs faster than normal saline (NS) and shorten length~     of stay (LOS) significantly for moderately to severely ill infants with bronchiolitis without~     apparent adverse effects.~   "
186726|NCT01120483|"~     Malnutrition is a common phenomenon in cancer patients. Deteriorated nutritional status is~     associated with poor clinical outcome. The purpose of this study is to determine the~     prevalence of hospital malnutrition and its impact on functionality, quality of life and~     mortality in cancer patients and to test the reference percentiles of phase angle values~     (Bosy Westphal et al JPEN 2006) as indicator of cancer cachexia and predictor of mortality.~      Hypothesis:~      The fifth reference percentile of the phase angle norm values is a prognostically relevant~     cut off value indicating cancer cachexia in terms of malnutrition, fatigue and impaired~     functional status, as well as predictive of 6-month mortality~   "
186727|NCT01120470|"~     This study is being offered to patients who have castrate-resistant (also known as~     hormone-refractory) prostate cancer. The cancer has metastasized or spread outside the~     prostate area to other parts of the body or has recurred in the pelvic area after treatment.~      The purpose of this clinical research study is to determine whether OGX-427 is able to slow~     the progression of prostate cancer and symptoms of disease when given with prednisone better~     than when prednisone is given alone in patients with prostate cancer whose disease has spread~     outside the prostate area.~      Research Hypothesis:~      That adding OGX-427 to prednisone treatment will produce a progression free rate of 20%.~   "
186728|NCT01120457|"~     The purpose of this study is to assess the safety and tolerability of BMS-936564 (MDX-1338)~     in relapsed Acute myelogenous leukemia (AML) and other selected B-cell cancers and to~     determine the maximum tolerated dose (MTD) of the drug alone in relapsed/refractory AML~   "
186729|NCT01120444|"~     The purpose of this study is to compare the effects of bolus delivery of insulin when~     delivered either intradermally (in the skin) or subcutaneously (under the skin) in diabetics.~   "
186730|NCT01120431|"~     The purpose is to evaluate the safety and efficacy as well as the time and resources needed~     in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate~     dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.~   "
186731|NCT01120418|"~     The objective of this study is to evaluate the effect on corneal endothelial cell density~     changes when ISV-403 is administered for five (5) days compared to no drug treatment, in~     healthy subjects.~   "
186732|NCT01120405|"~     The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial~     necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon~     based general anesthesia procedure in patients with elevated cardiac risk scheduled for~     atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when~     compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.~   "
186733|NCT01120392|"~     Treatment with Nintendo wii is higher to physical therapy conventional in the quality of life~     and motor performance in patients with Parkinson's disease.~   "
186734|NCT01120379|"~     XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives~     of this study are~        -  To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in~          real world settings, and~        -  To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT)~          initiative. This initiative is designed to evaluate the composite of all death,~          myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free~          from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and~          that have been treated with drug eluting stents (DES) and extended dual antiplatelet~          therapy.~   "
186735|NCT01120366|"~     The objective of this study is to investigate the efficacy and safety of the humanized~     anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in~     combination therapy with methotrexate (MTX) in patients with an inadequate response to~     treatment with MTX.~      Furthermore, in patients who have been able to achieve control of disease activity via the~     above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is~     restarted after disease recurrence.~   "
186736|NCT01120353|"~     The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer~     and its associated therapies. A retrospective cohort study will be conducted through a~     multi-institutional collaboration, which will involve the identification and active follow-up~     of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age,~     between 1970 and 1999 and 10,000 sibling controls. This project will study children and young~     adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or~     surgery, who are at increased risk of late-occurring adverse health outcomes. A group of~     sibling controls will be identified and data collected for comparison purposes.~   "
186768|NCT01119937|"~     This is a 52-week, multi-center, randomized, open label, parallel group study to assess the~     long term safety and tolerability of once-daily NVA237, using tiotropium as an active~     control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease~     (COPD) .~   "
186738|NCT01120327|"~     1. OBJECTIVES~           Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max,~          mL/kg/min) in amlodipine group against no CCB group at 9 months~           Secondary objectives To evaluate the change of sublingual nitrate use per day against no~          CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at~          9 months~        2. SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed~          significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea~   "
186739|NCT01120314|"~     Primary Objective:~        -  To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of~          Otamixaban.~      Secondary Objective:~        -  To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and~          severe renal impairment and in matched subjects with normal renal function.~   "
186740|NCT01120301|"~     The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser~     therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with~     acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject~     between 4.5 and 24 hours of stroke onset.~   "
186741|NCT01120288|"~     Background:~      - A protein called HIF is believed to be involved both in forming cancers and helping them to~     grow after they are formed. EZN-2968 is a new type of cancer drug that goes into the cancer~     cell and switches off the production of the HIF protein. Researchers are interested in~     testing EZN-2968 in people who have liver cancer because studies have shown that this drug~     travels to the liver and stays there when the drug is given through a vein.~      Objectives:~      - To determine the safety and effectiveness of EZN-2968 on liver cancer.~      Eligibility:~      - Individuals 18 years of age and older who have been diagnosed with liver cancer that has~     not responded to standard treatments.~      Design:~        -  Participants will have an initial screening visit with a physical examination, blood and~          urine tests, and imaging studies to assess tumor size. Tumor biopsies may also be taken~          for research purposes.~        -  Participants will have an undefined number of 6-week treatment cycles of EZN-2968, given~          once a week for 3 weeks followed by 3 weeks without the drug.~        -  During each cycle, participants will have additional blood tests and imaging scans to~          assess tumor response to treatment.~        -  Cycles of treatment with EZN-2968 may continue until the treatment is not effective,~          illness requires participants to stop taking the study drug, or the participant chooses~          to withdraw from the study.~   "
186742|NCT01120275|"~     This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor~     RO4929097 works in treating patients with stage IV melanoma. Gamma-secretase/Notch signalling~     pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
186743|NCT01120262|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is studying blood samples from patients with metastatic prostate~     cancer previously treated with bicalutamide and goserelin.~   "
186744|NCT01120249|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth or by blocking blood flow to the tumor.~      PURPOSE: This phase III trial is studying everolimus to see how well it works in treating~     patients with kidney cancer who have undergone surgery.~   "
186745|NCT01120236|"~     This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to~     see how well they work when given with or without cixutumumab in treating patients with newly~     diagnosed metastatic prostate cancer. Androgens can cause the growth of prostate cancer~     cells. Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, may~     lessen the amount of androgens made by the body. Monoclonal antibodies, such as cixutumumab,~     can block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     It is not yet known whether bicalutamide, goserelin, or leuprolide acetate are more effective~     when given with or without cixutumumab in treating prostate cancer.~   "
186746|NCT01120223|"~     The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO~     80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has~     marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp®~     Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been~     performed in subjects younger than 18 years~   "
186747|NCT01120210|"~     The purpose of this study is to investigate the safety, tolerability, pharmacodynamics (how~     the study medication affects the body) and pharmacokinetics (how the drug is absorbed in the~     body, how it is distributed within the body and removed from the body over time) of an~     intravenous administration of JNJ-39588146 or placebo over a 3-hour period in patients with~     heart failure. The highest tolerated dose received during the first 3 hours of the study will~     be administered to some patients for an additional 18 hours. There will be up to 3 doses~     given throughout the administration period over a total of up to 21 hours.~   "
186748|NCT01120197|"~     The aim of this randomized controlled trial is to evaluate the effectiveness for~     health-related quality of life (HRQOL) of a 3-month course of exercises for a group of~     postmenopausal women with osteoporosis who has at least one vertebral fracture versus a~     control group (undertaking their usual activities). The course of exercises is devised in~     accordance with methods recommended in Rehabilitation treatment guidelines in postmenopausal~     and senile osteoporosis.~   "
186749|NCT01120184|"~     This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of~     trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with~     pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab~     (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive~     progressive or recurrent locally advanced or previously untreated metastatic breast cancer.~     Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be~     open-label, whereas Arms B and C will be blinded.~   "
186769|NCT01119924|"~     The purpose of this study is to evaluate the Efficacy and Safety of Smilon® in the Depression~     Patients with pain. Eligible patients will be randomly assigned to 1 of 2 arms, either~     Smilon® or placebo, and will receive the treatment for 8 weeks in this study.~   "
186750|NCT01120171|"~     This study will evaluate the efficacy, safety and effect on quality of life of~     liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second~     line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy~     of the combination will be correlated with the functional status of patients according to the~     comprehensive geriatric assessment~   "
186751|NCT01120158|"~     This study will evaluate the efficacy, safety and effect on quality of life of weekly~     paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with~     metastatic breast cancer. Furthermore, the efficacy of the combination therapy will be~     correlated with the functional status of patients according to the comprehensive geriatric~     assessment.~   "
186752|NCT01120145|"~     The purpose of this study is to determine the efficacy and effectiveness of~     sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy for reducing~     malaria-associated morbidity in pregnant women in Malawi.~   "
186753|NCT01120132|"~     The purpose of this study is to determine the efficacy and safety of the administration of~     cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic~     conjunctivitis.~   "
186754|NCT01120119|"~     Reduction in vitamin D levels has been reported in subjects with recent onset type 1~     diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases~     the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in~     the disease pathogenesis. We investigated whether the supplementation of the active form of~     vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual~     beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c~     and insulin requirement.~      Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1~     diabetes (<12 weeks duration) and high basal C-peptide >0.25 nmol/l were randomized in a~     double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3~     [1,25-(OH)2D3] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.~   "
186755|NCT01120106|"~     Calcium sensitizer drugs such as Levosimendan may exert anti-ischemic effect in addition to~     positive inotropic and anti-stunning effects mediated by the opening of ATP-sensitive~     potassium (KATP) channels. The aim of the study is to test the myocardial protection effect~     of peri-operative iv infusion of Levosimendan in a cohort of neonates affected by~     transposition of the great arteries undergoing surgical correction by arterial switch.~   "
186756|NCT01120093|"~     The present trial is conducted to further assess the efficacy by means of serial spirometry,~     safety and tolerability of three doses of aclidinium bromide administered twice a day~     compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with~     moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment.~     Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between~     them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a~     follow up contact 14-days after last treatment dose.~   "
186757|NCT01120080|"~     The goal of this study is to train phone counselors working for the New York (NY) State~     Smokers' Quitline to advise callers who drink at hazardous levels to limit or abstain from~     alcohol use to determine whether this improves smoking cessation outcomes so that we can~     establish effect size estimates for a full scale multi-site trial.~   "
186758|NCT01120067|"~     This study is investigating the efficacy of an intensive (3 week) integrated treatment for~     Veterans with both pain and PTSD.~   "
186759|NCT01120054|"~     Objectives include: 1) establishing a psychometrically sound traumatic brain injury (TBI)~     screening measure for use among homeless veterans; 2) identifying the prevalence of those~     that screen positive for TBI among homeless veterans seeking VA services; and 3) comparing~     psychiatric and psychosocial outcomes between those with and without a history of TBI.~   "
186760|NCT01120041|"~     The purpose of this study is to determine whether giving brief motivational interviewing~     counseling during the prenatal and/or postnatal period(s) will increase utilization of~     preventive dental care and improve the oral health of rural, low-income pregnant and~     postpartum women and their children, and to increase the number of home oral health practices~     taken by these women to prevent caries in their young children.~   "
186761|NCT01120028|"~     The 3C study will investigate whether reducing exposure to calcineurin inhibitors (by using~     more potent antibody induction treatment and/or an elective switch to sirolimus) can improve~     the function and survival of kidney transplants.~   "
186762|NCT01120015|"~     The purpose of this study is to evaluate clinical effectiveness of diacerein as add on~     therapy to diclofenac sodium in Indian patients of osteoarthritis (OA) knee.~   "
186763|NCT01120002|"~     A double blind, placebo-controlled randomized study to evaluate the efficacy and safety of~     orally administered Tamibarotene to patients of Alzheimer's Disease~   "
186764|NCT01119989|"~     10 healthy male volunteers will be studied after~        -  a 6 day weight maintenance, balanced diet~        -  a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body~          weight/day~        -  a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body~          weight/day and 20g amino-acids per day At the end of each 6 days period, the following~          measurements will be obtained~        -  intrahepatic lipids (1H-MRS)~        -  metabolic effects of fructose ingestion (measurement of substrate oxidation,~          gluconeogenesis from fructose, palmitate synthesis from fructose, plasma VLDL-kinetics)~      This is a randomized, double blinded study~   "
186765|NCT01119976|"~     This is a research study to look at the association between weight loss and the menstrual~     cycle in healthy, overweight, premenopausal women. Participants will be asked to follow a~     reduced-calorie diet and exercise plan for 3 months.~   "
186766|NCT01119963|"~     The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone~     caproate (17P, Makena®) given to women with preterm rupture of the membranes will:~        1. increase the probability of continuing the pregnancy until a favorable gestational age.~        2. increase the interval between randomization and delivery.~        3. decrease neonatal morbidity.~   "
186767|NCT01119950|"~     This study was designed to investigate the efficacy and safety of NVA237, a long-acting~     muscarinic antagonist, in patients with moderate to severe COPD.~   "
186770|NCT01119911|"~     We hypothesize that peripheral venous catheter used for fluid administration can replace~     venipuncture blood sampling for selected basic analytes and thus reduce pain in infants under~     2 years of age.~   "
186771|NCT01119898|"~     Osteoarthritis (OA) is the most common form of arthritis and can cause pain, swelling, and~     reduced motion in the joints, which as a result can impact quality of life. It can occur in~     any joint, but usually affects the hands, knees, hips or spine. The purpose of this study is~     to determine the efficacy and safety of a topical nonsteroidal anti-inflammatory drug (NSAID)~     gel formulation in the treatment of osteoarthritis of the knee.~   "
186772|NCT01119885|"~     The purpose of this study is to investigate the utility of fentanyl matrix for the treatment~     of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by~     non-opioid analgesic (e.g. NSAIDs or COX-II inhibitors) or weak opioids [tramadol~     HClacetaminophen, tramadol or codeine (or combinations with acetaminophen/ibuprofen)].~   "
186773|NCT01119872|"~     Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome~     (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters~     of water (cmH2O), to compare two different methods of selecting the level of Positive~     End-Expiratory Pressure (PEEP) to be applied: according to fraction of inspired oxygen (FiO2)~     needed or individualized according to the best compliance. Primary objective was evolution of~     arterial oxygenation during the 28 days. Secondary objectives were to measure its effects on~     hemodynamic parameters, 28-day mortality, number of ventilator-free days at day 28, Intensive~     Care Unit (ICU) and hospital stay, number of multiple-organ dysfunction-free days and a~     multivariate analysis of 28 day-mortality.~   "
186774|NCT01119859|"~     This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab~     (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis~     who are intolerant of methotrexate or where continued treatment with methotrexate was~     considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg~     intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or~     adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to~     last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of~     the treatment administration, but the investigator and the patient remained blinded.~   "
186775|NCT01119846|"~     The purpose of this study is to see if GSK1292263 is safe and well-tolerated when~     administered to type 2 diabetics, and to get preliminary information about whether it may be~     effective in the treatment of type 2 diabetes.~   "
186776|NCT01119833|"~     GMI-1070 is a new drug that may reduce the stickiness of cells in the blood. The purpose of~     this study is to evaluate whether GMI-1070 can reduce the time it takes for pain to go away~     in patients with vaso-occlusive crisis (also known as a sickle cell pain crisis). The study~     will also collect information on the safety of GMI-1070, how much of the drug is in the blood~     and urine, and if there are any other effects when used in patients who are in the hospital~     for a sickle cell pain crisis.~   "
186777|NCT01119820|"~     Analyze human skeletal muscle and learn more about the ability of adult muscle to produce~     myoblasts (young muscle cells).~   "
186778|NCT01119807|"~     The objective of this study will be to compare humeral and tibial IO needle insertions to~     peripheral IV access during cardiac arrest.~      Hypothesis There is a difference in first attempt success of tibial IOs compared to humeral~     IOs or peripheral IV among cardiac arrest patients.~      Methods This will be a randomized controlled trial conducted within Mecklenburg County by the~     Mecklenburg County EMS Agency (MEDIC). The study population includes all adult (greater than~     18 years of age) cardiac arrest patients of a medical etiology upon whom resuscitative~     efforts are initiated.~      Patient Care Protocols Prehospital protocols for adult cardiac arrest patients within~     Mecklenburg County state that all first responders follow advanced cardiac life support~     (ACLS) algorithms during cardiopulmonary resuscitation. Current MEDIC protocols specify that~     initial vascular access be obtained by paramedics via either tibial or humeral IO needle~     insertion, followed by peripheral IV for secondary access. This study will randomize initial~     vascular access to a humeral IO, tibial IO, or peripheral IV.~      Once paramedics arrive on-scene, they will take a pack from the ambulance containing all~     necessary supplies to begin resuscitation. These packs are already present on each ambulance~     in Mecklenburg County and contain an EZ-IO drill, IO needles, ACLS medications, and KING LTD~     airway device. For the purposes of this study, peripheral IV start kits will be added to~     these resuscitation packs at the start of study implementation.~      Randomization Process~      150 note cards will be prepared in advance and labeled with a vascular access method. [50~     cards with Tibial IO, 50 cards Humeral IO, 50 cards with Peripheral IV] Each note card~     will be sealed in a blank, numbered envelope. A master list will be prepared in advance~     according to envelope number indicating which vascular access method was placed in each~     numbered envelope. This list will only be available to the MEDIC Quality Assurance/Quality~     Improvement (QA/QI) personnel responsible for paramedic debriefing and recirculation of~     unused envelopes.~      Sealed envelopes will then be shuffled and placed at the MEDIC circulation window where~     resuscitation packs and ambulance equipment are distributed daily.~      Each crew will randomly select and open an envelope prior to every shift. By opening the~     envelope at the start of the day, this will eliminate the possibility of envelopes being left~     in the ambulance unit or lost at the scene, as well as prevent delays with patient care.~      The envelope number will be recorded at the circulation window indicating the specific MEDIC~     ambulance unit and assigned crew.~      The vascular access route selected will apply to the crew's first cardiac arrest of the day.~      Resuscitation Protocol~      Paramedics will conduct the resuscitation according to existing procedure, and will proceed~     with vascular access as follows depending on the method selected by randomization:~      Tibial IO First attempt will be a tibial IO. Second attempt should occur on the opposite~     tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as~     selected by the paramedic.~      Humeral IO First attempt will be a humeral IO. Second attempt should occur at the tibia if~     the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs~     as determined by the paramedic.~      Peripheral IV First attempt will be a peripheral IV in the AC. If this fails, second attempt~     will be a tibial IO, followed by a humeral IO when indicated.~      Since it is extremely rare for any crew to conduct more than one cardiac arrest on a given~     day, the randomized vascular access method will only apply to the first cardiac arrest of the~     day. As crews do not return to the distribution center until the end of a shift (12 hours),~     it will be impossible to select additional envelopes for subsequent patient encounters.~     Paramedics will proceed with vascular access per current MEDIC prehospital protocols for any~     further cardiac arrest resuscitations that day.~      If there is a contraindication to the vascular access site selected such as extremity~     amputations, orthopedic hardware, skin infection, or traumatic injuries, paramedics will~     proceed to the next insertion site as per the above protocol. For instance, if a patient with~     bilateral lower extremity amputations is randomized to a tibial IO insertion site, paramedics~     will classify this as a failed attempt and proceed to humeral IO, then peripheral IV as~     stated above. For patients with isolated skin infections or orthopedic hardware involving one~     extremity, paramedics will select the unaffected extremity for the first attempt. Any~     unforeseen circumstances will be addressed according to the paramedics' discretion and~     reported to the primary investigator immediately. Such occurrences will be included in the~     final data analysis for this study.~   "
186779|NCT01119794|"~     The purpose of this study is to: Investigate the Overall Response Rate (ORR) of the~     combination of ofatumumab and bortezomib in patients with low-grade B-cell non-Hodgkin~     lymphoma (LG-NHL) that relapse beyond 6 months of a previous rituximab-containing regimen.~   "
186780|NCT01119781|"~     The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose~     of PEGylated Interferon Beta-1a (BIIB017) administered subcutaneous in participants with~     renal impairment and in participants with normal renal function (healthy participants). A~     secondary objective of this study in this study population is to evaluate the safety and~     tolerability of a single dose of PEGylated Interferon Beta-1a administered subcutaneous.~   "
186781|NCT01119768|"~     To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and~     2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis~     patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.~   "
186782|NCT01119755|"~     This is a prospective study to evaluate the change in 24 hour ambulatory blood pressure~     during winter and summer in well controlled treated hypertensives.~   "
186783|NCT01119742|"~     To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine~     hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the~     treatment of interdigital tinea pedis, and to show the superiority of the active treatments~     over that of the placebo (vehicle).~   "
186784|NCT01119729|"~     Human immunodeficiency virus (HIV) infection has been associated with a variety of~     cardiovascular diseases. Even most industrialised countries exhibit a growing and aging~     population of HIV-infected patients in the majority treated with antiretroviral drugs, the~     investigators still do not know much about the impact of cardiovascular diseases in this~     group of patients. The present study is an ongoing trial that was conducted as a prospective~     and multicentre survey, being schemed to analyse the frequency and clinical course of cardiac~     disorders in HIV-infected patients.~   "
186785|NCT01119716|"~     This study will create a prospective registry of consecutive patients with Atrial~     Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of~     in-hospital treatment, with a focus on the characterization of type of Afib, as well as on~     treatments applied (drugs, devices, interventions and their combinations), and associated~     complications within 60 days after enrollment.~   "
186786|NCT01119703|"~     This study evaluated whether it is possible in healthy elderly participants to generate~     baseline biomarker-based prediction rules (PdR) for vaccine response (post baseline absolute~     serum antibody titer) using each of the protocol selected vaccines separately; and examined~     the rank correlation coefficients of pairs of post vaccination antibody titers within the~     same elderly individuals.~   "
186787|NCT01119690|"~     In this study, the effects of dietary intake of cold-pressed turnip rapeseed oil (CTPRO) and~     milk fat are compared in men with metabolic syndrome having already participated in HMS-02~     study.~   "
186788|NCT01119677|"~     The primary objective of the study is to determine whether titration of Avonex reduces the~     severity of flu-like symptoms (FLS). Secondary objectives of this study are to determine~     whether titration of Avonex reduces the incidence of FLS and to evaluate the overall safety~     and tolerability of Avonex intramuscular (IM) injections.~   "
186791|NCT01119638|"~     Behavioral and psychological symptoms of dementia (BPSD) are among the most distressing~     manifestations of dementia. Pharmacotherapy is frequently used and especially in~     institutional settings. Current guidelines recommend the use of second-generation~     antipsychotics (SGAs). Nonetheless, there are concerns regarding both their safety and~     effectiveness in patients with dementia. Inconclusive evidence support the use of other~     psychoactive agents such as SSRI antidepressants or cognitive enhancers.~      In two published studies citalopram was as efficacious as, but better tolerated than~     perphenazine or risperidone in patients with BPSD.~      Thus, with proven efficacy and a beneficial safety profile the evaluation of the use of~     escitalopram for BPSD is warranted.~   "
186792|NCT01119625|"~     This primary purpose of this study is the evaluation of the immunological persistence~     following completion of the 3-dose primary vaccination course with either a clinical or a~     commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In~     addition, the study will also assess the safety, reactogenicity and immunogenicity of a~     fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when~     co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study~     NCT00808444.~      The primary vaccination study was conducted in Malaysia and Singapore. The booster~     vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine~     GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be~     offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia~     and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally~     recommended regimen. Administration of the booster dose will be outside the set-up of a~     clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.~   "
186793|NCT01119612|"~     The purpose of this study is to determine safety and efficacy of prenatal iron~     supplementation in an area of high malaria burden among women who are not anemic or iron~     deficient.~   "
186794|NCT01119599|"~     This phase I trial studies the side effects and best dose of gamma-secretase/Notch signalling~     pathway inhibitor RO4929097 (RO4929097) when given together with temozolomide and radiation~     therapy in treating patients with newly diagnosed malignant glioma. Enzyme inhibitors, such~     as gamma-secretase/Notch signalling pathway inhibitor RO4929097, may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as temozolomide, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gamma-secretase/Notch~     signalling pathway inhibitor RO4929097 together with temozolomide and radiation therapy may~     kill more tumor cells.~   "
186795|NCT01119586|"~     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly~     diagnosed high-risk acute lymphoblastic leukemia.~   "
186796|NCT01119573|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying at biomarkers in tissue samples from patients with~     stage I or stage III endometrial cancer.~   "
186797|NCT01119560|"~     This research trial studies the genes biomarkers in children with neuroblastoma. Studying the~     genes in a child's cancer cells may help doctors improve ways to diagnose and treat children~     with neuroblastoma.~   "
186798|NCT01119547|"~     The purpose of this study is to investigate if inclusion of exercise in an education program~     for patients with osteoarthritis can improve self efficacy, self-perceived health and~     function.~   "
186799|NCT01119534|"~     It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol,~     by their pharmacological properties already established for each component, has the ability~     to reduce the signs and symptoms related to upper respiratory infections in a manner~     equivalent (not inferior) to medicine used as a comparator in this study and higher than the~     suppository containing only guaiacol concentration of 12.5 mg.~   "
186800|NCT01119521|"~     The purpose of this research is to further study the tuberculosis (TB) vaccine, Bacillus~     Calmette Guérin (BCG). The goal of this study is to evaluate whether the BCG vaccine is more~     effective in preventing TB in adults if it is given after 6 months of treatment with a widely~     used anti-TB drug, isoniazid (INH). Participants will include 82 healthy, tuberculin skin~     test positive (TST+), HIV-uninfected, male and female volunteers, aged 18-40 years. The study~     will be conducted in Worcester, South Africa. Subjects will be assigned by chance to 1 of 2~     possible treatment groups. Group 1 will receive 6 months of oral INH treatment followed by~     intradermal (administered into the skin) BCG revaccination and one year of follow-up. Group 2~     will be observed for 7 months which will be followed by intradermal BCG revaccination and~     another 6 months of follow-up. Then 6 months of INH treatment will be given. Participants~     will be involved in study procedures for about to 22 months.~   "
186801|NCT01119508|"~     The goal of this clinical research study is to learn if combining ipilimumab and temozolomide~     can help to control metastatic melanoma. The safety of this drug combination will be studied.~     Researchers would also like to study how this therapy affects the levels of certain chemicals~     in the blood that are related to your immune system.~   "
186816|NCT01119300|"~     Rationale:~      The narrow therapeutic range and wide inter-patient variability in dose requirement make~     anticoagulation response to coumarin derivatives unpredictable. As a result, patients require~     frequent monitoring to avert adverse effects and maintain therapeutic efficacy. Polymorphisms~     in cytochrome P450 2C9 (CYP2C9) and vitamin K epoxide reductase complex 1 (VKORC1) jointly~     account for about 40% of the inter-individual variability in dose requirements. To date,~     several pharmacogenetic guided dosing algorithms for coumarin derivatives, predominately for~     warfarin, have been developed. However, the potential benefit of these dosing algorithms in~     terms of their safety and clinical utility has not been adequately investigated in randomised~     settings. Objective:~      To determine whether a dosing algorithm containing genetic information increases the time~     within therapeutic INR range during anticoagulation therapy with each of warfarin,~     acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain this~     information. Secondary outcomes of the study include cost effectiveness, number of~     thromboembolic and bleeding events, time to reach stable dose and number of supratherapeutic~     INR peaks.~   "
186802|NCT01119482|"~     Meningococcal disease occurs throughout the world but attack rates in the Sahelian and~     sub-Sahelian regions of Africa - the African meningitis belt - are many times higher than~     those seen in any other part of the world. During 2009, over 70,000 meningitis cases and~     3,200 deaths were reported in Nigeria, Niger, and Chad alone.~      In 2001, a public private partnership between WHO and PATH was created, the Meningitis~     Vaccine Project (MVP). The MVP set out to develop an affordable meningococcal serogroup A~     conjugate vaccine (MenAfriVac™) for use in the African meningitis belt. This was successfully~     achieved, and the new vaccine, produced by the Serum Institute of India (SII), was granted a~     licence in 2009 for international export. The vaccine dossier was submitted to WHO for~     prequalification at the beginning of 2010. Introduction through mass vaccination is planned~     in three African Meningitis belt countries in 2010 (Burkina Faso, Mali and Niger). The~     implementation of MenAfriVac will be the responsibility of the local Ministry of Health, with~     the support of the World Health Organization.~      It is anticipated that this vaccine will be deployed in other countries of the meningitis~     belt in 2011. This vaccine should provide high levels of direct protection to immunised~     individuals but, as for serogroup C conjugate vaccines in the United Kingdom, a greater~     public health impact will be achieved if carriage and transmission of the infection are also~     prevented.~      The London School of Hygiene & Tropical Medicine (LSTHM) is coordinating the African~     Meningococcal Carriage Consortium (MenAfriCar). One of the primary objectives of the~     MenAfriCar project is to evaluate the impact of the new conjugate vaccine on meningococcal~     carriage and transmission of serogroup A meningococci in Mali, Niger and Chad. A~     community-based prospective, pre- and post intervention, observational study will be~     conducted. MenAfriCar will also help to develop research capacity in the participating~     African countries.~   "
186803|NCT01119469|"~     This study will compare the efficacy of cognitive therapy and exposure therapy for treating~     hypochondriasis.~   "
186804|NCT01119456|"~     A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in patients with~     solid tumor. Patients can either be dosed once a week, or once every other week.~   "
186805|NCT01119443|"~     Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d.~     under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.~   "
186806|NCT01119430|"~     The purpose of this study is to examine whether the speed of the clinical antidepressant~     action of fluoxetine can be accelerated by administering DU125530 a full 5-HT1A antagonist.~   "
186807|NCT01119417|"~     The purpose of this study is to test the hypothesis that endothelin plays a role in the~     pathogenesis of supine hypertension in pure autonomic failure by increasing vascular~     resistance. To gauge its contribution to blood pressure regulation, pure autonomic failure~     and multiple system atrophy patients with supine hypertension will undergo a medication~     testing with the endothelin blocker, BQ123. We will compare the hemodynamic effects between~     PAF and MSA patients. Our primary endpoint will be the decrease in blood pressure during the~     administration of this compound.~   "
186808|NCT01119404|"~     Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a~     part of Hämeenlinna Metabolic Syndrome Research Program (HMS) surrogate indicators for~     atherosclerosis are studied in 120 men with metabolic syndrome, 120 men with coronary heart~     disease and 80 physically active controls and in different settings.~   "
186809|NCT01119391|"~     Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any~     behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle.~     This study examines the effects of health habits surrounding exercise, smoking, alcohol,~     sleep, caffeine, herbal medications, acupuncture, and diet on pregnancy rates during IVF~     cycles. The purpose of this study is to determine if lifestyle behaviors have a significant~     impact on pregnancy rates during treatment with IVF.~      This is an observational study conducted at a private academically-affiliated infertility~     clinic and includes 118 women ages 44 and below scheduled to undergo IVF treatment. All~     subjects were asked to complete a health history survey at the time of enrollment and a daily~     survey during each day of their IVF cycle. The primary outcome is clinical pregnancy rate.~   "
186810|NCT01119378|"~     The purpose of this study is to determine the capability to absorb calcium as a measure of~     the sufficient levels of Vitamin D. Calcium absorption will be measured at baseline and after~     vitamin D3, by dual calcium isotope technique using stable isotopes in post menopausal women~     between the ages 50 and 70yrs. Subjects will have a screening visit, first and final visits.~     Subjects will be randomly assigned to a placebo or daily doses of vitamin D3. The specific~     aim of this study is to determine the level of vitamin D that will maximize the absorption of~     calcium and establish the relationship between the administered calcium dose and the actual~     absorbed calcium dose versus administered dose of Vitamin D and the serum levels of Vitamin~     D.~   "
186811|NCT01119365|"~     Light is the primary means by which the internal circadian clock remains aligned~     (entrained) with the external world. Misalignment of this internal clock can occur during~     situations such as shift work and jet travel across multiple time zones (jet lag). The~     purpose of this study is to examine the parameters of light and how they affect entrainment~     of the clock.~   "
186812|NCT01119352|"~     The aim of the study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of AZD7687 following multiple ascending dose administrations in in~     overweight to obese but otherwise healthy male subjects~   "
186813|NCT01119339|"~     The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004~     in a Psoriasis Plaque Test (PPT)~   "
186814|NCT01119326|"~     The purpose of this research study is to find out if it is safe and feasible to improve the~     appearance and quality of a scar by using a procedure in which adipose tissue (fat) is taken~     from other parts of your body and injected, or transplanted into a scar. This procedure is~     called autologous fat transfer (AFT). The main goal of this study is to see if AFT is safe~     and can improve the quality and appearance of scar tissue. Another main goal is to determine~     how much tissue should be transplanted to get the best results.~   "
186815|NCT01119313|"~     The aim of the study is an intra-individual comparison of skin conditions in addition to a~     patient based assessment of product appearance in the topical treatment of atopic eczema.~   "
186817|NCT01119287|"~     The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to~     placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels~     in an Environmental Exposure Chamber (EEC).~   "
186844|NCT01118936|"~     The present study is part of a project titled 'Magnesium in asthma and chronic obstructive~     pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement~     will benefit patients with asthma and chronic obstructive pulmonary disease.~      The aim of this part of the project is to study the effect of a daily magnesium supplement~     for COPD-patients~   "
194533|NCT01017172|"~     The purpose of this study is to evaluate the immunogenicity and safety of an adjuvanted~     A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients after one and two~     injections.~   "
186818|NCT01119274|"~     Rationale:~      The narrow therapeutic range and wide inter-patient variability in dose requirement make~     anticoagulation response to coumarin derivatives unpredictable. As a result, patients require~     frequent monitoring to avert adverse effects and maintain therapeutic efficacy. Polymorphisms~     in cytochrome P450 2C9 (CYP2C9) and vitamin K epoxide reductase complex 1 (VKORC1) jointly~     account for about 40% of the inter-individual variability in dose requirements. To date,~     several pharmacogenetic guided dosing algorithms for coumarin derivatives, predominately for~     warfarin, have been developed. However, the potential benefit of these dosing algorithms in~     terms of their safety and clinical utility has not been adequately investigated in randomised~     settings.~      Objective:~      To determine whether a dosing algorithm containing genetic information increases the time~     within therapeutic INR range during anticoagulation therapy with each of warfarin,~     acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain this~     information. Secondary outcomes of the study include cost effectiveness, number of~     thromboembolic and bleeding events, time to reach stable dose and number of supratherapeutic~     INR peaks.~      Study design:~      This is a two-armed, single-blinded, randomised controlled trial. In one arm (intervention)~     patients commencing anticoagulation therapy with either warfarin, acenocoumarol or~     phenprocoumon will be dosed according to a drug-specific genotype-guided dosing algorithm,~     which is based on genetic information, clinical data and (in the monitoring phase) previous~     INR. For the other arm (control) patients will be dosed according to a non-genotype-guided~     dosing regimen which does not include genetic information. The follow-up period per patient~     is 3 months.~      Study population:~      Newly diagnosed patients of both genders and at least 18 years old who need anticoagulant~     treatment with either acenocoumarol, phenprocoumon or warfarin within the low intensity INR~     range will be included in the trial. Main study parameters/endpoints: The % time within~     therapeutic INR range in the first 3 months of anticoagulation therapy. Nature and extent of~     the burden and risks associated with participation, benefit and group relatedness: Six extra~     blood samples are taken from each participant at the start of the study. Patients also have~     to attend 8 scheduled visits within the 3 months study period and are asked to fill in~     questionnaires. The genotype-guided dosing algorithm is anticipated to improve the accuracy~     of coumarin dosing and thus improve the safety and efficacy of anticoagulation therapy.~   "
186819|NCT01119261|"~     Rationale:~      The narrow therapeutic range and wide inter-patient variability in dose requirement make~     anticoagulation response to coumarin derivatives unpredictable. As a result, patients require~     frequent monitoring to avert adverse effects and maintain therapeutic efficacy. Polymorphisms~     in cytochrome P450 2C9 (CYP2C9) and vitamin K epoxide reductase complex 1 (VKORC1) jointly~     account for about 40% of the inter-individual variability in dose requirements. To date,~     several pharmacogenetic guided dosing algorithms for coumarin derivatives, predominately for~     warfarin, have been developed. However, the potential benefit of these dosing algorithms in~     terms of their safety and clinical utility has not been adequately investigated in randomised~     settings. Objective: To determine whether a dosing algorithm containing genetic information~     increases the time within therapeutic INR range during anticoagulation therapy with each of~     warfarin, acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain~     this information. Secondary outcomes of the study include cost effectiveness, number of~     thromboembolic and bleeding events, time to reach stable dose and number of supratherapeutic~     INR peaks. Study design: This is a two-armed, single-blinded, randomised controlled trial. In~     one arm (intervention) patients commencing anticoagulation therapy with either warfarin,~     acenocoumarol or phenprocoumon will be dosed according to a drug-specific genotype-guided~     dosing algorithm, which is based on genetic information, clinical data and (in the monitoring~     phase) previous INR. For the other arm (control) patients will be dosed according to a~     non-genotype-guided dosing regimen which does not include genetic information. The follow-up~     period per patient is 3 months. Study population: Newly diagnosed patients of both genders~     and at least 18 years old who need anticoagulant treatment with either acenocoumarol,~     phenprocoumon or warfarin within the low intensity INR range will be included in the trial.~     Main study parameters/endpoints: The % time within therapeutic INR range in the first 3~     months of anticoagulation therapy. Nature and extent of the burden and risks associated with~     participation, benefit and group relatedness: Six extra blood samples are taken from each~     participant at the start of the study. Patients also have to attend 8 scheduled visits within~     the 3 months study period and are asked to fill in questionnaires. The genotype-guided dosing~     algorithm is anticipated to improve the accuracy of coumarin dosing and thus improve the~     safety and efficacy of anticoagulation therapy.~   "
186820|NCT01119248|"~     The number of children undergoing MRI imaging has increased significantly in the past years,~     because many young children cannot stay still for the duration of the scan, have difficulty~     tolerating the confined space and the noise produced by the Magnetic Resonance Imaging (MRI)~     machine, sedation or General Anesthesia is required in these cases. In the investigators~     institution, the investigators use General Anesthesia for children undergoing MRI.~      Because children have a larger surface area to body weight ratio; hypothermia from passive~     heat loss is one of the anesthesiologists' concerns.~      MRI requires a cool environment with low humidity; this specialized environment represents a~     significant thermal challenge to the anesthetized children. Since most temperature devices~     are not compatible with the MRI, the simple task to measure temperature change has never been~     investigated.~   "
186821|NCT01119235|"~     A new tablet form of PF-04531083 has been manufactured. Previously the compound was~     administered as a solution/suspension to healthy volunteers. This study will investigate the~     pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics~     obtained, with the same dosing regimen, with the solution/suspension.~   "
186822|NCT01119222|"~     Human experimental pain models are useful in understanding the mechanisms underlying clinical~     pain conditions and can be used to test the analgesic efficacy of drugs used in the~     management of pain. Once established these models can be used as mechanism biomarkers in~     early development clinical studies to establish proof of mechanism for novel compounds. The~     cold pain model is a mechanistic pain biomarker with potential application in proof of~     mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research~     Unit and demonstrate we can effectively screen subjects for this model and examine the effect~     of morphine, diphenhydramine, and gabapentin in the cold pain model.~   "
186823|NCT01119209|"~     Reducing pain is an essential factor for early mobilization after osteosynthesis of~     intertrochanteric fractures. Systemic opioids have side effects that might obstruct~     mobilization and induce delirium and nausea. The investigators hypothesized that wound~     infiltration results in reduction in systemic opioid usage and pain relief without side~     effects.~   "
186824|NCT01119196|"~     The goal of this study is to examine the relevance of insulin resistance in peritoneal~     dialysis (PD) patients as well as the means to improve this metabolic derangement. We will do~     so through a prospective randomized study using Icodextrin as an alternate dialysate solution~     to routine glucose-based dialysate. We hypothesize that (1) the glucose loading associated~     with PD leads to impairment in insulin sensitivity, (2) the degree of insulin resistance is~     dependent on the basal metabolic state (fasting versus stimulated), and (3) the replacement~     of conventional dialysate with glucose-sparing dialysate preparations will improve insulin~     resistance and associated metabolic disturbances in PD patients.~   "
186825|NCT01119183|"~     Participants counseled with the preeclampsia educational tool will have a better~     understanding of preeclampsia than those not counseled using the tool.~   "
186826|NCT01119170|"~     In this study the investigators want to test the safety of D-lactate producing probiotics in~     babies from birth to 1 month of age. Previous data demonstrated no increase in urinary~     D-lactate in 4 month old infants supplemented with D-lactate producing probiotics. The~     primary purpose of this study is to evaluate the influence of D-lactate producing probiotics~     on D-lactate excretion in young infants during the neonatal period (days 0 - 28).~   "
186884|NCT01118416|"~     The primary aim of this study is to test a brief 4-session risk reduction intervention, based~     on Motivational Enhancement Therapy (MET) to reduce the co-occurrence of club drug use and~     sexual risk taking behaviors among non-treatment seeking young men who have sex with men~     (YMSM) in NYC.~   "
186828|NCT01119144|"~     Hypothesis: Polycaprolactone / Tricalcium Phosphate Orbital (PCL / TCP) Implant is as~     effective in the reconstruction of the Orbital walls as Titanium Mesh implant.~      In this study we will be conducting a randomised trial to compare implants made of 2~     materials for Orbital reconstruction~        -  Polycaprolactone / Tricalcium Phosphate (PCL / TCP)~        -  Titanium~      Patients to be recruited :~        -  80 randomised equally into the 2 groups~        -  age range: 21 - 70~        -  includes orbital wall defects from trauma, after osteotomies~        -  excludes patients with Diabetes Mellitus, known allergies to polycaprolactone & its~          analogues, know allergies to Tricalcium Phosphate & its analogues, infections~          generalised & around the orbital region~      Trial Duration: April 2010 - March 2015~      Follow up:~        -  postoperative 1 week, 1 month, 3 months, 6 months, and 12 months~        -  Computer Tomographic (CT) scan of Orbits immediate postoperative and at 12 months~          appointment~   "
186829|NCT01119131|"~     A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls,~     strength, and cognition in persons with Parkinson's disease.~   "
186830|NCT01119118|"~     The purpose of this research study is to assess the effects of ZD4054 on prostate cancer that~     has spread to the bones by using new imaging techniques. In particular, this study will use~     fluorodeoxyglucose (FDG) and 18F-Sodium Fluoride (NaF) PET/computed tomography (CT) and MRI~     scans to look for changes in bone metastasis after ZD4054 therapy.~   "
186831|NCT01119105|"~     This is a Phase II, multi-center, randomized, double-blind study comparing the safety and~     efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and~     skin structure infection.~   "
186832|NCT01119092|"~     The purpose of this study is the examine the effects of gentle movements applied to the ankle~     joint and stretching on self-reported function, ankle motion and stiffness in individuals who~     have suffered from an ankle sprain within the last year and have decreased ankle motion.~   "
186833|NCT01119079|"~     In current obstetric anesthesia practice, epidural analgesia is the most effective technique~     to control labor pain for those women who request pain-free delivery. Epidural analgesia not~     only allows us to obtain greater pain relief and increased satisfaction of mothers, but also~     permits us to convert it to regional anesthesia in case of operative delivery, avoiding~     general anesthesia.~      One of the major concerns with epidural anesthesia in labor setting is the inability to~     produce an intensive analgesia or adequate level to proceed with cesarean section. This study~     is designed to examine the hypothesis that 10ml epidural normal saline to reduce rate of~     one-side block, low segmental block, and patch block, and improve quality of labor epidural~     analgesia/ anesthesia in obstetric population.~   "
186834|NCT01119066|"~     The purpose of this study is to find out the effects of using a system called CliniMACS to~     remove Tcells from blood stem cells. Removing T-cells may help stop a side effect called~     Graft-Versus-Host Disease (GVHD). Some studies have been done with CliniMACS, but the Food~     and Drug Administration (FDA) has not yet approved it.~   "
186835|NCT01119053|"~     In this monocentre two-armed double blind randomised placebo-controlled study - in which the~     control group obtains the VNS therapy within a defined space of time after 12 weeks - the~     impact of vagus nerve stimulation on depressive symptomatology of patients with~     therapy-resistant depressive personality disorders shall be analysed. Particularly in~     comorbid disorders, medicamentous treatment shows exceedingly bad response rates. Against the~     background of hitherto insufficient treatment strategies for chronic or persistent depression~     with comorbidities, the proceeding of a study on the effects of VNS on depressive patients~     with comorbid disorders is absolutely essential.~   "
186836|NCT01119040|"~     The purpose of this study is to determine:~        1. Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic~          gastrostomy) PEG tube.~        2. Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic~          Surgery (NOTES) in lieu of traditional surgical methods.~        3. Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical~          methods.~   "
186837|NCT01119027|"~     The purpose of this study is to improve the investigators understanding of different training~     methods in laparoscopic colon surgery.~   "
186838|NCT01119014|"~     The benefits and harms of antipsychotics are relatively well studied in adults. However,~     there is a lack of scientifically valid studies regarding the benefits and harms of~     antipsychotics in children and adolescents with psychosis.~      The main objective of the TEA trial is to compare the efficacy and adverse reactions of two~     antipsychotics (quetiapine versus aripiprazole) in children and adolescents between 12-17~     years of age with psychotic symptoms on psychopathology, cognitive deficits, and daily~     functioning. Furthermore, the trial will focus on adverse reaction profiles of the two~     antipsychotics as well as early predictors of later sustained clinical effects of these~     antipsychotics.~   "
186839|NCT01119001|"~     People with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer~     interface (BCI) keyboard to type in assistive technology devices. The results of this study~     will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.~   "
186840|NCT01118988|"~     This protocol matches child subjects with peer mentors of similar age who have learned to~     function successfully with a chronic pain disorder. The trained mentors will present~     information to the subjects in a supervised and monitored interaction via telephone and~     computer for 2 months and encourage participation in skill-building programs. Children will~     be tested for improvement in pain and functioning at 2 months and again at 4 months to see if~     improvements persist. The investigators hypothesize that children who received peer mentor~     support will show more improvement in pain and functioning at 2 and 4 months into treatment~     than those in a control group who do not receive mentor support.~   "
186841|NCT01118975|"~     This research is being done to find out how safe and how well the combination of lapatinib~     and vorinostat works against advanced cancers.~   "
186842|NCT01118962|"~     The purpose is to obtain data on the safety and seizure frequency associated with long-term~     oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects~     with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed~     SP0961 (NCT01118949) to continue to receive Lacosamide.~   "
186843|NCT01118949|"~     The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary~     Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.~   "
186845|NCT01118923|"~     The present study is part of a project titled 'Magnesium in asthma and chronic obstructive~     pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement~     will benefit patients with asthma and chronic obstructive pulmonary disease.~      The aim of this part of the project is to study the effect of a daily magnesium supplement on~     the grade of bronchial hyperreactivity in asthmatics.~   "
186846|NCT01118910|"~     The purpose of this study is to determine if people with moist, red, patches on their skin in~     body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.~   "
186847|NCT01118897|"~     SUMMARY~      PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced~     Gallbladder and Pancreatic cancers: A Phase II study~      SPECIFIC OBJECTIVES:~      Primary To assess the radiological response by dose escalated IMRT in locally advanced~     inoperable gallbladder and pancreatic cancers.~      Secondary~        1. To assess the resectability rate with microscopic negative margin (R0).~        2. To assess the acute and late toxicities (Number of Participants with Adverse Events as a~          Measure of Safety and Tolerability)~        3. To study the locoregional control in the patients undergoing R0 resection~        4. To study overall survival~      DESIGN: Phase II study~      STUDY POPULATION: All patients of age >18 years years diagnosed with non metastatic locally~     advanced inoperable gall bladder and pancreatic cancer~      STUDY SIZE: 60 patients~      METHODOLOGY: Sixty cases will be screened and taken for study if eligible after taking the~     informed consent.~      Patients will receive radiotherapy using Tomotherapy based IMRT with concurrent chemotherapy~     Gemcitabine weekly. The response will evaluated at 6 weeks post chemoradiation and if~     operable will undergo surgery, if still inoperable or metastatic will receive palliative~     chemotherapy.~      PROJECT PERIOD:~      Total project period : 3 years Recruitment, Data collection : 2 years Complete analysis of~     data : 1 year~      STUDY SITE: Tata memorial centre~   "
186848|NCT01118884|"~     The purpose of this study is to compare the safety and efficacy of sedation using orally~     administered midazolam and promethazine with nitrous oxide/oxygen in uncooperative children~     receiving dental treatments.~   "
186849|NCT01118871|"~     The purpose of this study is to look at two different antiretroviral treatment options in~     individuals who are about to commence their second antiretroviral treatment.~      This study will assess important clinical and laboratory differences between these two~     therapeutic options. Potential differences include: differences in body fat distribution, in~     lipid parameters, in adherence and in neurocognitive (brain) function. This study is looking~     to show differences in body fat distribution between the two study treatment arms.~     Differences in lipids, viral load, adherence, cardiac and bone biomarkers and neurocognitive~     function will also be assessed. There is also a lumbar puncture sub study participants can~     also take part in.~      The total duration of involvement in the trial will be up to 96 weeks (approximately 2 years)~     plus a screening visit 1 - 4 weeks prior to the start of the study. Including visit the~     clinic on 12 occasions (screening visit, baseline visit, weeks 2, 4, 8, 12, 24, 36, 48, 64,~     80 and 96)~   "
186850|NCT01118858|"~     Cytochrome P450 2D6 (CYP2D6) is an important enzyme in the body for breaking down many~     medications that are commonly used in children of various ages. The purpose of this proposal~     is to investigate the relative roles of development and genetic variation in CYP2D6 activity~     in school-aged children and adolescents with attention deficit and hyperactivity disorder and~     health controls using the over-the-counter cough suppressant, dextromethorphan or DM, a~     standard probe for determining CYP2D6 phenotype. Embedded in the study design are sub-studies~     to search for by-products of normal body metabolism that reflect differences in enzyme~     activity, and a pharmacokinetic study to assess the consequences of CYP2D6 genetic variation~     on the systemic exposure to medications used by this patient population. Ultimately, the goal~     of the research is to personalize the use of medications in children by selecting the~     appropriate dose of the correct medication for individual patients.~   "
186851|NCT01118845|"~     The purpose of this study is to determine the efficacy of SyB L-0501 in combination with~     rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.~   "
186852|NCT01118832|"~     A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions~     and melanoma is developed. Goals include evaluation of the utility of high-resolution~     infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the~     identification of high-risk lesions and melanomas.~   "
186853|NCT01118819|"~     This protocol will examine the safety of intravenous administration of Clostridium novyi-NT~     spores in patients with treatment-refractory solid tumor malignancies. This investigational~     study will measure anti-tumor activity of C. novyi-NT administered intravenously in patients~     with treatment-refractory solid tumor malignancies.~   "
186854|NCT01118806|"~     the study aims to messure the vitamin D levels in medical staff in the hospital. The~     physicians in the course of their internship who work indoors and work many night shifts have~     limited sun exposure in all seasons. Nursing staff who work shifts and work indoors are at~     the same risk of liltle sun exposure. The study addresses the amount of sun exposure,~     assessed by a sun exposure questioner, age, gender,work load related to number of shifts in~     the physicien group and in nursing group the job percentile we also adress religion (clothing~     cover)as a factor.~   "
186855|NCT01118793|"~     This is a Scripps pilot study on the effect of high clopidogrel maintenance dosing and its~     relationship to cytochrome P450 2C19 polymorphism status [STSI/CTSA].~   "
186856|NCT01118780|"~     The purpose of this study is to test the safety and efficacy of duloxetine versus placebo in~     elderly patients suffering from generalized anxiety disorder (GAD).~   "
186857|NCT01118767|"~     The investigators propose to develop and evaluate a computer-based intervention using cell~     phones to enhance adherence to antiretroviral treatment (ART) and support of HIV transmission~     risk-reduction among adult HIV-positive patients in Peru.~   "
186858|NCT01118754|"~     The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and~     effectively improve signs and or symptoms of dry eye disease.~   "
186859|NCT01118741|"~     disulfiram is a DNA methyltransferase inhibitor that may provide benefit for patients with~     prostate cancer by restoring tumor suppressor genes.~   "
186860|NCT01118728|"~     Primary Objective:~        -  To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with~          ankylosing spondylitis (AS)~      Secondary Objective:~        -  To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS~   "
186861|NCT01118715|"~     Distal radius fractures (DRF) are the most common type of fracture in the human body, and a~     large proportion of DRFs result in complications. Previously proposed preventive strategies~     have questionable efficacy and may impose additional risks on the patient. Because many~     complications secondary to distal radius fractures are associated with excessive swelling, a~     prophylactic means for edema reduction could dramatically reduce morbidity among this~     population. A compression glove is a non-invasive, non-pharmacological way to reduce edema.~     Previous studies have confirmed its utility in edema reduction after hand trauma and among~     patients with chronic inflammatory conditions, but none have sufficiently investigated the~     application to patients with distal radius fractures, a population in which this intervention~     could have a large impact. The investigators propose a randomized controlled trial to~     evaluate use of a compression glove during recovery among patients who have sustained an~     unstable distal radius fracture. The investigators hypothesize that patients who wear a~     compression glove after a distal radius fracture:~        -  Will experience less edema~        -  Will demonstrate greater functionality~        -  Will recover more quickly~        -  Will have lower incidence rates of carpal tunnel syndrome~        -  Will have lower incidence rates of complex regional pain syndrome~   "
186862|NCT01118702|"~     This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24~     hour period after they take this medication.~   "
186863|NCT01118689|"~     The purpose of this study is to determine the safety, tolerability, maximum tolerated dose~     and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or~     Waldenstrom Macroglobulinemia~   "
186864|NCT01118676|"~     This is a two-center study which includes 24 patients maximum on 36 months : 24 months~     accrual - 12 months follow up.~      Eligible patients are included according to a standard 3+3 design.~      Patients included in the trial will be treated with a combination of radiochemotherapy~     (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based~     chemotherapy).~      Cilengitide will be administered alone as continuous infusion two weeks before the~     radiochemotherapy and will then be continued during radiochemotherapy as continuous infusion.~      The dose levels investigated will be applied to the continuous administration (a maximum of 4~     dose levels).~      After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a~     dose of 2000 mg twice weekly until the end of chemotherapy.~      The dose of Cilengitide administered after radiotherapy will not be increased. 4 dose levels~     are defined:12, 18, 27 et 40 mg /hour.~   "
186865|NCT01118663|"~     The primary purpose of this study is determine if a new formulation of Acetadote is at least~     as effective as the current formulation in the prevention and treatment of acetaminophen~     overdose related liver injury.~   "
186866|NCT01118650|"~     To demonstrate concordance between the Quotient ADHD System Report and standard DSM-IV based~     parent and teacher reported rating/assessment scales, currently the accepted method of~     symptom measurement for subjects diagnosed with Attention-Deficit/Hyperactivity Disorder~     (ADHD).~   "
186867|NCT01118637|"~     Trichotillomania (TTM), repetitive pulling out of one's own hair to the extent that~     noticeable hair loss occurs, is a distressing condition interfering substantially with~     functioning and quality of life. The longterm objective of this research is to determine~     whether psychological treatment of TTM could be disseminated more effectively by using a~     stepped care model in which less intensive interventions are tried first, with more intensive~     interventions used only if initial treatment proves insufficient. This project is a pilot~     study of the first two steps in a stepped care model of treatment. After baseline assessment,~     50 participants with TTM will be randomly assigned to (a) Immediate condition, in which they~     are offered 10-week self-help treatment via an interactive website (Step 1) or (b) Wait~     List/Delayed Start condition, a 10-week wait list prior to being offered Step 1. In each~     condition, at the end of Step 1, participants will be offered 8 weeks of in-person habit~     reversal training provided by psychology graduate students (Step 2). TTM symptoms will be~     measured from baseline through a follow-up 3 months after the end of Step 2, as will~     depression, anxiety, quality of life, functional impairment , treatment utilization, and~     treatment satisfaction.~      The specific aims of the study are:~        1. To gather preliminary data on the efficacy of web-based self-help, compared to wait list~          control;~        2. To characterize the acceptability of stepped care to patients with TTM by assessing the~          proportion of enrolled participants who proceed from step 1 to step 2 treatment;~        3. To evaluate the convergent validity of four decision rules for concluding that a patient~          with TTM has benefited sufficiently from a treatment step: (a) No longer meeting TTM~          diagnostic criteria; (b) Showing a 25% or greater reduction in total scores on~          self-report and clinician-rated TTM symptoms; (c) achieving complete abstinence from~          hair-pulling; and (d) clinically significant response on both self-report and~          clinician-rated TTM symptom measures~        4. To evaluate the concurrent and predictive validity of criteria for sufficient benefit~          from a treatment step by relating them to treatment satisfaction, treatment utilization,~          and scores on a measure of functional impairment from TTM.~   "
186868|NCT01118624|"~     The purpose of this study is to determine the efficacy (ability to provide a beneficial~     treatment of the disease) of pralatrexate for the treatment of female patients with advanced~     or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin~     B12 and folic acid supplementation.~   "
186869|NCT01118611|"~     RATIONALE: Aurora B/C kinase inhibitor GSK1070916A (GSK1070916A) may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of GSK1070916A in~     treating patients with advanced solid tumors.~   "
186870|NCT01118598|"~     Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its~     lipid lowering as well as via pleiotropic effects in patients with polycystic ovary syndrome~     (PCOS).~   "
186871|NCT01118585|"~     The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD~     patients treated in routine clinical practice at multiple centers across the United States.~   "
186872|NCT01118572|"~     Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in~     patients with postoperative pain.~   "
186873|NCT01118559|"~     This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male~     adult subjects.~   "
186874|NCT01118546|"~     Aspirin is very effective in protecting patients with coronary artery disease against adverse~     cardiac events, because it is a potent antiplatelet agent. Some patients may develop a~     history of hypersensitivity to aspirin and treatment cannot usually be resumed in these~     patients. We have developed a rapid procedure to induce tolerance in these patients~     (SILBERMAN et al, Am J CARDIOL 2005;95:509-10) and wish to test whether aspirin is as~     effective as antiplatelet agent in patients with a history of allergy to aspirin and who~     undergo desensitization as it is in patients without history of hypersensitivity~   "
186901|NCT01118169|"~     The primary aim of this study is to examine the relationship between personal values and~     suicidal thoughts in a sample of U.S. Veterans.~   "
186875|NCT01118533|"~     Orotracheal intubation following general anesthesia requires blades to be performed. The risk~     of patients contamination with infectious agents related to reusable metal blades leads to~     promote single-use blades. Some of these latter are plastic and this material may need more~     strength to lift the jaw and expose the larynx before orotracheal intubation. Sometimes,~     change of blade, from plastic to metal, during the procedure is necessary to increase the~     larynx exposure. This change of blade may increase the frequency of sore throat following~     orotracheal intubation.~      Consequently, the study hypothesis is an increase of both sore throat intensity and frequency~     with the plastic blades compared with the metal blades.~      The primary purpose of the present study is to compare the impact of these two types of~     blades, metal versus plastic, on sore throat intensity and frequency following scheduled~     orotracheal intubation for general anesthesia~   "
186876|NCT01118520|"~     Abdominal aortic aneurysms (AAA) are balloon-like swellings of the body's main blood vessel~     (aorta) as it courses through the abdomen. As a result of the National Aneurysm Screening~     programme many more of these will be detected. Small AAAs grow slowly and remain a benign~     condition until the diameter exceeds 2-3 times the diameter of the normal aorta (about 5.5cm~     in size), when operative repair of the aneurysm is recommended avoiding the potentially fatal~     event of bursting and bleeding (aneurysm rupture). It is therefore important to identify a~     strategy to prevent aneurysm growth.~      There is a suggestion that the use of a specific drug class, angiotensin converting enzyme~     (ACE) inhibitors, may reduce the risk of rupture of the larger aneurysms. This trial will~     assess whether an ACE inhibitor (perindopril) has aneurysm-related benefits, in patients with~     small AAAs at screening centres in the London area.~      The effects of perindopril versus a placebo(dummy) on AAA growth rates will be compared. In~     addition by comparing the effects of perindopril with the effects of equivalent blood~     pressure lowering with another non-ACE inhibitor class of drug (amlodipine) on aneurysm~     growth rate, we can see whether any benefits of perindopril are simply the result of lowering~     blood pressure. 225 Patients will be assigned to one of these 3 treatments by chance~     (randomisation).In addition to analysis of the effect of perindopril and blood pressure~     lowering,the effect of the treatments on quality of life will be assessed. Patients will~     return at 3-monthly intervals for an ultrasound scan and blood pressure measurements, with~     questionnaires regarding quality of life at the start and end of the 2-year research period.~      An ultrasound scan is a painless test that uses sound waves to create images of organs and~     structures inside your body.~   "
186877|NCT01118507|"~     Demonstrate that the High output shotgun sequencing of the foetal DNA in the maternal blood~     could allow a complete discrimination between the mothers of a trisomic fetus 21 or a~     DISOMIQUE foetus 21 from the first quarter of the pregnancy, and so to obtain a reliable~     alternative in invasive procedure.~   "
186878|NCT01118494|"~     Chronic kidney disease (CKD) that results in end-stage renal disease (ESRD) is a major~     international health problem. Many clinical markers such as urine protein or eGFR(evaluated~     glomerular filtration rate),can estimate the renal function, but not sensitive. As~     well-known, the crucial role of angiotensin II (AngII), the major effector of the~     renin-angiotensin system (RAS), in the development of renal fibrosis that results in ESRD is~     widely recognized.Abundant researches find that intrarenal RAS takes an important role on the~     progression of CKD. At present, no clinical marker is available to evaluate intrarenal AngII~     activity because it is difficult to measure it directly in patients. So find and establish a~     bio-marker of local renal RAS activation maybe a breakthrough in early detection and~     treatment of CKD. Angiotensinogen(AGT) is the only known substrate for renin and the level of~     AGT in humans is close to Km value for renin. Thus , changes in AGT levels can control the~     activity of the RAS, and its up-regulation may lead to activity of Ang levels. Then we~     hypothesis that the AGT is a early bio-marker of local renal RAS activation as well as CKD.~   "
186879|NCT01118481|"~     Narrowing of coronary arteries interferes with blood flow and can cause chest pain.~     Cardiologists sometimes quantify the extent of the narrowing by measuring the fractional flow~     reserve (the ratio of the pressure in the aorta to the pressure downstream of the narrowing~     under conditions of maximal flow). We propose a new technique based on principles of wave~     intensity analysis (WIA) to better assess coronary stenosis and the significance of the~     narrowing without the need for administration of vasodilator agents such as adenosine. This~     would simplify assessment and improve our ability to advise patients whether stent treatment~     will help their symptoms.~   "
186880|NCT01118468|"~     Narrowing of the arteries that supply blood to the heart can lead to heart attacks and death.~     One way of treating this is to use artery and vein grafts from other parts of the body to~     bypass the narrowing. However, the blood flow from these grafts competes with flow through~     the natural coronary artery. This may contribute to grafts narrowing with time. This protocol~     aims to determine the pressure changes responsible for this effect. This could improve our~     understanding of why some grafts last longer than others.~   "
186881|NCT01118455|"~     This is a randomized study designed to compare long-term treatment outcomes in pediatric~     patients with refractory seizures treated with VNS (Vagus Nerve Stimulation) Therapy versus~     anti-epileptic drugs (AEDs). Seizure reduction, quality of life measures, and side effect~     profiles will be evaluated. The results of this study will provide controlled comparative~     data to better guide physicians in determining the best overall treatment strategy for~     patients with seizures who have failed initial AED therapy.~   "
186882|NCT01118442|"~     Narrowing of the main valve which controls blood leaving the heart leads to a marked increase~     in death. To overcome this narrowing the heart muscle thickens abnormally and contracts more~     vigorously. However, in doing so, blood flow patterns to the heart muscle change through~     mechanisms which are incompletely understood. New technology allows such heart valve~     blockages to be fixed using balloons and metal stents inserted through tubes placed in~     arteries in the leg. Using sensors placed in these tubes it is possible to make detailed~     measurements of coronary flow and pressure, and apply new mathematical techniques to allow a~     better understanding of the detrimental effects that aortic stenosis has on coronary flow,~     before and after valve surgery.~   "
186883|NCT01118429|"~     The objective of this study was to evaluate the effectiveness and patient satisfaction with~     the use of oxybutynin at low doses for treating axillary hyperhidrosis in a large series of~     patients.~   "
186885|NCT01118403|"~     This study seeks to assess whether coma patients really benefit from the use of antibiotics~     as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this~     population group. For this we consider the use of ampicillin sulbactam antibiotic which has a~     low ability to induce resistance, efficacy and safety observed during the time that has been~     used, even in patients with neurosurgical pathology, and to be broadly available in our~     environment.~      Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation,~     the application of antibiotic prophylaxis compared with placebo reduces the incidence of~     early ventilator-associated pneumonia.~   "
186886|NCT01118390|"~     Studying the results of treatment of dilated vessels of the lower limbs with laser, and~     compare them to those obtained with sclerotherapy.~   "
186887|NCT01118377|"~     This study evaluated the effect of capecitabine and concomitant radiation therapy in children~     with newly diagnosed brainstem gliomas.~   "
186888|NCT01118364|"~     Assess the effect of cigarette smoking of tobacco with or without addition of resin cannabis~     on driving performance in healthy volunteers in simulated driving in Marseille and Toulouse,~     and in real world driving to Bordeaux.~      Multicenter Study of phase 1, randomized, double-blind, cross plan, carried out in healthy~     male volunteers.~   "
186889|NCT01118351|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth or by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients~     with recurrent transitional cell bladder cancer.~   "
186890|NCT01118325|"~     The purpose of the study is to determine the drug characteristics of Ticagrelor, and to~     determine if 4 weeks treatment will reduce the blood clotting.~   "
186891|NCT01118312|"~     The trial will study the effectiveness of nasal steroids for the treatment of chronic~     rhinitis and/or sinusitis on asthma control.~   "
186892|NCT01118286|"~     To investigate the therapeutic effectiveness of long acting nifedipine containing combination~     therapy in the treatment of hypertensive patients.~   "
186893|NCT01118273|"~     The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen~     sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and~     an ibuprofen and diphenhydramine combination~   "
186894|NCT01118260|"~     Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing~     transurethral prostate resection~   "
186895|NCT01118247|"~     Both HA coated and certain uncoated femoral stems have good results in general. On the cup~     side the results are more variable, either with or without HA. HA may delaminate from the~     prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening.~      The investigators are investigating whether a well working uncemented hip prosthesis design~     with HA coating, will perform without HA in the long run, when the investigators use pure Ti~     macrostructure and alumina on alumina articulation.~      Hypothesis: The bone ingrowth will be equal when the surface has almost equal roughness in Ti~     and HA version. This means that HA on Ti is not necessary with a well functioning prosthesis~     design.~      0-hypothesis:The two prosthesis perform equal in survival, clinically (HHS),radiographic and~     in patient satisfaction at 2, 5, 10, 15 and 20 years.~   "
186896|NCT01118234|"~     The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to~     prolong progression free survival in patients with chronic lymphocytic leukemia, who~     responded to a Rituximab induction therapy.~   "
186897|NCT01118221|"~     The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more~     often in older males. Cigarette smoking and environmental dust exposures are known risk~     factors for developing IPF. For example, the recently deployed military population, as it~     ages, is at especially increased risk of IPF. No effective therapies exist, although lung~     transplantation is used to extend survival of selected patients.~      Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus~     an urgent priority of veteran-oriented research programs.~   "
186898|NCT01118208|"~     This quantitative, interview-based study will determine if increased prescription medication~     adherence via blister pack administration will reduce suicide related behavior among the high~     risk population of patients discharged from a psychiatric inpatient unit. The aims of the~     project are to determine whether blister packaging medication significantly increases~     treatment adherence and if blister packaging significantly decreases intentional~     self-poisoning behavior (i.e., suicide attempts and completions). By tracking former~     psychiatric inpatients for 12 months post-discharge and obtaining monthly medication~     adherence ratings, we will determine if blister packaging (BP) medications leads to better~     adherence than dispensing as usual (DUA). The psychiatric patients we will be recruiting have~     been diagnosed with, major affective disorder, bipolar affective disorder, post-traumatic~     stress disorder, or schizophrenia (or any combination of these diagnoses). By tracking former~     psychiatric patients for 12 months post-discharge and obtaining monthly reports (self-report~     and medical record review) of suicide-related behaviors, we will determine if patients in the~     BP condition have less intentional self-poisoning behavior than those in the DAU condition.~   "
186899|NCT01118195|"~     This is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The~     purpose of this research is to find out more about the issues related to these conditions.~     This study seeks to explore the relationship between executive dysfunction and suicidal~     behavior in an outpatient population.~   "
186900|NCT01118182|"~     The primary aims of this study are to: 1) Establish the concurrent criterion-related validity~     of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State~     University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent~     criterion-related validity of the TBI-4 with the addition of detailed information elicited by~     the four questions. Secondary aims include: 1) Determining if the addition of detailed~     information elicited by the TBI-4 results in increased specificity; 2) Determining whether~     the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous~     research; and 3) Determining whether psychiatric outcomes are worse for veterans with~     traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).~      Primary Hypotheses:~      Hypothesis 1a: The sensitivity and specificity of the TBI-4 will be significantly greater~     than 0.75 and 0.80, respectively.~      Hypothesis 1b: The sensitivity and specificity of the TBI-4 with the addition of detailed~     information elicited by these questions (i.e., free text information entered by the clinician~     who administered the TBI-4) will be significantly greater than 0.75 and 0.80, respectively.~      Secondary Hypotheses:~      Hypothesis 1c: The specificity of the TBI-4 with the addition of detailed information~     elicited by these questions (i.e., free text information entered by the clinician who~     administered the TBI-4) will be significantly greater than that of the four questions alone.~      Hypothesis 2: A significant difference in psychiatric outcomes (psychiatric hospitalizations,~     suicidal ideation, suicide attempts and completions, and mental health-related contacts) will~     be identified in those with a history of TBI versus those without a history of TBI as~     determined, first, by the TBI-4 and, second, by the OSU TBI-ID.~      Hypothesis 3: The prevalence of Traumatic Brain Injury- Loss of Consciousness (TBI-LOC) in~     this population will be similar to that identified by Walker et al1 (31.7% of individuals~     will report 1 or more TBI-LOC).~   "
186903|NCT01118143|"~     The purpose of this study to investigate attitude, oral health literacy and psychological~     factors in order to evaluate if these factors are important for oral health in adults.~      The hypotheses are:~        -  Multiple interactive demographic, and social and psychological factors contribute to the~          level of attitude and oral health literacy.~        -  There is an association between the level of oral health literacy and oral health status~        -  A structured intervention based on oral health literacy can change the attitude and~          improve the oral health status.~        -  Background knowledge has influence on attitude and oral health literacy~        -  Individuals with positive attitude towards dental health and dentist are attentive~          towards their oral health.~   "
186904|NCT01118130|"~     To investigate whether genotypic differences can be identified between MS patients developing~     'liver injury' (defined as ALT levels five times the upper normal limit and above) compared~     to those not developing liver injury after exposure to beta-interferon for MS.~   "
186905|NCT01118117|"~     OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects~     will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral~     Self Expanding stent once all of the inclusion and none of the exclusion criteria are met.~     The stent efficacy and safety will be evaluated immediately post procedure, and at 30 days,~     6, 12, 24, and 36 months post procedure. A subject is considered enrolled into the OSPREY~     study after he/she signs the informed consent and meets all inclusion/exclusion criteria.~      The study objectives are to demonstrate that efficacy and safety of this novel stent design~     are not inferior to historical Percutaneous Transluminal Angioplasty (PTA) and stent outcomes~     and meet the performance goals as published in the objective performance goals by~     Rocha-Singh, et al. This is a multi-center, single arm, non-randomized, prospective clinical~     trial of the Misago™ Self-Expanding Stent System for the treatment of atherosclerotic~     stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated~     at 12 months.~   "
186906|NCT01118104|"~     People with chronic respiratory disease have shortened work life, their disease is associated~     with greater work disability and they are at greater risk of being unemployed. Lower~     employment rates and higher sickness absence is expensive for the community and leads to~     financial as well as social consequences for the individual.~      There is a lack of data on factors that can predict sickness absence and disability in~     patients with pulmonary disease. We therefore want to study a group of people with COPD and~     asthma referred to our clinic. The study will investigate relationships between sickness~     absence and exercise capacity, job-related factors, disease severity, self-efficacy, health~     related quality of life and subjective health complaints.~   "
186907|NCT01118091|"~     Background:~      - Adoptive cell therapy involves taking white blood cells called lymphocytes from patients'~     tumors, growing them in the laboratory in large numbers, and then giving the cells back to~     the patient to allow the cells to attack the tumor. Because this process is lengthy and~     difficult to perform, researchers have been developing improved means of performing adoptive~     cell therapy. Researchers are now interested in comparing adoptive cell therapy with the~     standard treatment for metastatic melanoma (skin cancer).~      Objectives:~      - To compare the effectiveness of adoptive cell therapy with standard high-dose aldesleukin~     as a treatment for metastatic melanoma.~      Eligibility:~        -  Individuals 18 years of age or older who have been diagnosed with metastatic melanoma~          and have not previously received aldesleukin therapy or cell therapy for their disease.~        -  Participants must have at least one tumor that can be easily removed as part of the~          treatment procedure.~      Design:~        -  Participants will be screened with a full medical history, physical examination, blood~          and urine tests, and imaging scans to evaluate tumor size and treatment options.~        -  Participants will be separated into two groups, in which one group will have adoptive~          cell therapy and one will have aldesleukin treatment.~        -  Adoptive Cell Therapy~             -  Participants will have a tumor sample taken in order to collect white blood cells~               for treatment. Participants whose tumors do not provide sufficient white blood~               cells may be switched to the aldesleukin-only treatment group.~             -  The white blood cells will be grown in the laboratory for several weeks.~             -  Prior to receiving cell therapy, participants will receive chemotherapy for 7 days~               to improve the chances of successful treatment.~             -  Participants will have cell therapy followed by high-dose aldesleukin treatment~               every 8 hours for up to 5 days. This treatment will be followed by 1 to 2 weeks of~               recovery time as an inpatient at the clinical center.~             -  Participants will be evaluated at 12 weeks following the start of the study, every~               2 to 3 months for the first year, every 6 months for the next 5years, and then~               yearly thereafter..~        -  Standard Aldesleukin Treatment~             -  Participants will have high-dose aldesleukin treatment every 8 hours for up to 5~               days (one cycle of treatment), and will have a second cycle of treatment 7 to 10~               days after the first cycle.~             -  If tests show that the tumors have grown, participants will be offered the chance~               to have additional cycles of aldesleukin, or begin a cell therapy treatment.~        -  Participants will be evaluated at 12 weeks following the start of the study, every 2 to~          3 months for the first year, every 6 months for the next 5years, and then yearly~          thereafter.~   "
186908|NCT01118078|"~     This research study is studying biomarkers in tissue samples from patients with high-risk~     Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors to learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~   "
186909|NCT01118065|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with~     progressive or recurrent, unresectable, or metastatic thyroid cancer.~   "
186910|NCT01118052|"~     This phase II trial studies the side effects and how well EGEN-001 works in treating patients~     with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that is~     persistent or has come back. Biological therapies, such as EGEN-001, use substances made from~     living organisms that may stimulate or suppress the immune system in different ways and stop~     tumor cells from growing.~   "
186911|NCT01118039|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying the side effects of giving sunitinib malate and to~     see how well it works in treating patients with locally recurrent, locally advanced,~     unresectable, or metastatic urinary tract cancer.~   "
186922|NCT01117896|"~     This prospective, randomized experimental trial to determine whether the quality of~     healthcare provider/rescuer chest compressions (CC) deteriorates at the same rate in~     pediatric models as compared to adult models. To determine the relationship between~     physiologic/metabolic markers of work in rescuers and chest compression deterioration, and to~     determine the effect of stepstool use on the quality of chest compressions and metabolic~     demand. To determine whether the quality of chest compressions deteriorates at the same rate~     in participants using a stepstool compared to those not using a stepstool.~   "
186923|NCT01117883|"~     This protocol is a prospective interventional pilot study at the Children's Hospital of~     Philadelphia to determine whether or not two increments of sternal pressure known to occur~     during leaning in CPR affects hemodynamic function, coronary perfusion pressures, and~     intrathoracic pressure in order to inform the resuscitation community on reasonable target~     pressures to avoid leaning on the chest during pediatric CPR.~   "
187592|NCT01109121|"~     This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study~     to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients~     with hyperuricemia and moderate to severe gout.~   "
186912|NCT01118026|"~     This research is being done in order to improve treatment outcomes in patients diagnosed with~     bulky, early stage Hodgkin lymphoma and to reduce the side effects that are associated with~     use of radiation used in current treatments. The chemotherapy treatment in this study~     consists of a combination of four drugs approved by the Food and Drug Administration (FDA):~     doxorubicin, bleomycin, vinblastine, and dacarbazine. This regimen (called ABVD) has been~     found to be effective in treating patients with Hodgkin lymphoma and is considered the~     standard of treatment used with radiation therapy in patients with bulky early stage Hodgkin~     lymphoma. As part of the evaluation of the effectiveness of the chemotherapy treatment, PET~     scans will be obtained during the course of therapy. The usefulness of this PET scan will be~     evaluated to determine whether radiation may be left out in the treatment of disease if the~     PET scan shows that the patient has responded to chemotherapy alone. The plan is to identify~     a group of patients using early PET scans in order to change to a chemotherapy treatment~     called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine,~     procarbazine and prednisone). It is one of the most highly effective chemotherapy regimens~     for Hodgkin lymphoma, but is associated with more side effects than ABVD. Although it has~     become standard of care in Europe, its use has been more limited in the U.S. because of~     concerns about toxicity.~   "
186913|NCT01118013|"~     RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a~     peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop~     the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted~     cells from a donor can make an immune response against the body's normal cells. Giving~     methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop~     this from happening. Once the donated stem cells begin working, the patient's immune system~     may see the remaining cancer cells as not belonging in the patient's body and destroy them~     (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells~     (donor lymphocyte infusion) may boost this effect.~      PURPOSE: This phase II trial is studying how well donor stem cell transplant works in~     treating patients with relapsed hematologic malignancies or secondary myelodysplasia~     previously treated with high-dose chemotherapy and autologous stem cell transplant .~   "
186914|NCT01118000|"~     Numerous studies Have shown that limb ischemic preconditioning can protect vital organs~     (including the heart) from ischemia-reperfusion injury,which has a broad application~     prospect.But its mechanism is still unclear. Evidence showed that humoral mechanisms may play~     an important role. This study was carried out on the limb ischemic preconditioning in healthy~     volunteers, collected their serum at different time points before and after~     treatment,classified and identified the serum proteins during different periods of limb~     ischemic preconditioning,by using methods including high abundant protein~     removal,Two-dimensional electrophoresis chromatography and mass spectrometry,then analysed~     activation and synthesis of the proteins in order to search for the proteins or peptides~     whose synthesis was activated by ischemic preconditioning. This study will be the first~     systemic explore of the changes in serum proteins of limb ischemic preconditioning in human~     body,and lay theoretical basis for the clinical application of limb ischemic preconditioning~     and for further explore of its humoral mechanism,thus provide clues for searching for protein~     or peptide having protective effects for organs.~   "
186915|NCT01117987|"~     This is a multinational, multi center extension study. This study will provide data on the~     long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary~     arterial hypertension.~   "
186916|NCT01117974|"~     Liposuction, one of the most common cosmetic procedures performed in the United States, is a~     surgical technique used to reduce localized areas of excess subcutaneous fat. The neck is a~     common area of treatment, where liposuction reduces fat volume and neck size. We hypothesize~     that suctioned removal of fat of the neck will reduce the severity of obstructive sleep~     apnea.~   "
186917|NCT01117961|"~     Study goal is to determine whether behavioral lifestyle intervention during pregnancy can~     reduce the number of women who exceed the Institute of Medicine recommendations for weight~     gain during pregnancy.~      It is hypothesized that the intervention will reduce the number of women who exceed weight~     gain guidelines relative to standard care. The investigators also expect the intervention to~     reduce the proportion of women exceeding weight gain guidelines in both normal weight and~     overweight groups.~   "
186918|NCT01117948|"~     Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study~     to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate probable~     Alzheimer's Disease.~      Study phase: II~      Indication: Alzheimer´s Disease~      Investigational product, dose schedule and route of administration: Lornoxicam (8 mg) tablets~     to be taken orally two times daily (BID) for a period of 6 months.~      Reference product, dose, schedule and route of administration: Placebo (8 mg) tablets to be~     taken orally two times daily (BID) for a period of 6 months.~   "
186919|NCT01117935|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy,~     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and~     cause less damage to normal tissue.~      PURPOSE: This clinical trial studies intensity-modulated external beam radiation therapy in~     treating patients with prostate cancer.~   "
186920|NCT01117922|"~     This is a randomized clinical trial in which all Philadelphia resident women experiencing a~     pre-term birth (PTB) at <34 weeks of gestation (GA) over an 18 month period will be~     approached at the time of the postpartum hospital stay. Consenting women will be randomized~     into a usual care group or an interconceptional intervention targeting five risk conditions,~     all of which increase systemic inflammation. Our primary objective in this study is to assess~     the efficacy of our interconceptional intervention on the rate of repeat PTB.~   "
186921|NCT01117909|"~     The goal is to determine if standard therapy including joint mobilizations of the ankle~     performed 3 times per week for 2 weeks will increase self-reported function and decrease pain~     in patients with mild lateral ankle sprains.~   "
186959|NCT01117415|"~     Participation in this research study does not involve any procedures. Health preference will~     be ascertained through standard techniques including time-tradeoff, standard gamble, and~     rating scale to assess risks regarding potential complications specific to NOTES (Natural~     Orifice Translumenal Endoscopic Surgery)gallbladder removal.~   "
186924|NCT01117870|"~     Pulsed RadioFrequency (PRF) is a relatively new technique derived from a well established and~     proven intervention, thermal radiofrequency (RF). Both procedures are used in the treatment~     of chronic pain. Unlike RF treatment, PRF does no direct damage to the nerve. During PRF~     treatment, electrical energy is applied with a small needle to the affected nerve using a~     pulsed time cycle that delivers short bursts of RF current. This study is interested in~     looking at the efficacy of PRF for chronic lumbar radicular pain (CLR) and to assess whether~     a larger scale clinical study with the same methods can be used.~   "
186925|NCT01117857|"~     The primary objective of the study is to determine if an eight-week intervention with~     duloxetine significantly reduces depressive symptoms in symptomatic menopausal women. It is~     hypothesized that an eight-week trial with duloxetine promotes significant improvement in~     depression symptoms in menopausal women. The secondary aim of the study is to examine if an~     eight-week intervention with duloxetine significantly reduces vasomotor symptoms in~     symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine~     promotes significant improvement in vasomotor symptoms in menopausal women.~   "
186926|NCT01117844|"~     This is a Feasibility/Phase II study for patients with a diagnosis of WHO Grade I - III~     Meningioma & Hemangiopericytoma brain cancer to be given standard dose Proton radiotherapy.~     The study will be performed in two phases: first, feasibility with an enrollment of 12~     patients and then Phase Page 8 of 20 II, with an enrollment of an additional 38 patients. All~     patients will also be given quality of life (QOL) instruments pretreatment, weekly during~     treatment, then q 3 months for year 1 post treatment, q6 months year 2 & 3 and yearly for~     year 4 & 5. Comparisons will be made between the enrolled subjects receiving proton therapy~     and the known literature on photon radiation. See section 2 for full objectives. The second~     phase will begin no earlier than 60 days after the last patient in the initial phase has~     completed treatment and once safety and feasibility has been verified. The secondary~     objectives will serve as the objectives for the second phase of the study.~   "
186927|NCT01117831|"~     Project: An analysis of Diabetes Control in Puerto Rico Hypothesis: This project seeks to~     determine the causes for: i) poor adherence to prescribed treatment by patients, ii) low~     compliance by providers with national guidelines iii) barriers impose by health insurance in~     control of diabetes mellitus iv) effectiveness of a disease management program for treatment~     adherence by patients.~   "
186928|NCT01117818|"~     This is a multiple vaccination study to find out if it is a safe treatment and what effects~     it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80~     years. Approximately 40 study sites in Europe will be involved. Patients will be randomized~     to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.~   "
186929|NCT01117805|"~     The proposed randomized controlled trial will evaluate an innovative intervention in 420~     African American women with asthma. It will be the first to use a highly tailored, telephone~     counseling approach to address both specific cultural factors affecting asthma and the~     influence of female sex and gender on control.~   "
186930|NCT01117792|"~     The primary objective is to evaluate the S-ICD system's ability to identify and terminate~     induced ventricular fibrillation in patients during the implant procedure. The safety and~     performance of the S-ICD system will also be assessed throughout the patient follow-up~     period.~   "
186931|NCT01117779|"~     TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have~     undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years~     of age or older who have been determined to be an appropriate candidate for cryoablation will~     be offered enrollment into the registry. Subjects will be observed for five years from the~     date of their cryoablation procedure.~   "
186932|NCT01117766|"~     Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to~     detect treatment efficacy in small-scale clinical trials. Combining conventional pain~     efficacy measures with quantitative sensory testing (QST) may provide more sensitive and~     informative outcome measures in clinical trials.~   "
186933|NCT01117753|"~     Adolescent substance abuse results in significant negative outcomes and extraordinary costs~     for youths, their families, communities, and society. Moreover, rates of psychiatric~     comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual~     diagnosis are more than twice as costly to treat compared to those with no comorbidity. The~     applicant principal investigator recently completed a pilot project funded by the National~     Institute on Drug Abuse focused on developing and piloting a psychosocial treatment~     specifically for youth presenting for outpatient treatment with co-occurring substance use~     and internalizing (i.e., mood and/or anxiety) problems. Results were promising with the~     experimental group exhibiting significantly less substance use and more rapid reductions in~     anxiety and depressive symptoms compared to the control group. The proposed research is a~     randomized clinical trial (RCT) to compare the experimental treatment (OutPatient Treatment~     for Adolescents; OPT-A) to an active placebo on key clinical indices from pre-treatment~     through 18 months. The proposed RCT (n = 160) employs the treatment manual, quality assurance~     protocol, and therapist training protocol developed and successfully tested in the pilot~     study, to evaluate the efficacy of OPT-A for youth referred to outpatient treatment of~     co-occurring substance use and internalizing problems. The following outcomes will be~     evaluated: drug use; mental health; behavioral, school, peer, and family functioning; and~     consumer satisfaction. The intervention addresses one of the more prevalent and most~     challenging, costly, and understudied presenting problems among adolescent outpatients. If~     successful, this research could provide a considerable contribution in the treatment field~     for youth with co-occurring substance use and internalizing disorders.~   "
186934|NCT01117740|"~     The goal of this clinical research study is to compare 2 different methods for treating a~     pleural effusion. Researchers also want to learn how the treatment you receive effects your~     quality of life (your ability to do the things you like to do and how happy you feel.~   "
186935|NCT01117727|"~     The purpose of this research is to develop tools to help people who are paralyzed. These~     tools are called brain-computer interfaces (BCIs). BCIs would allow a person to use brain~     signals to operate technology. Specifically this project's goal is to design a BCI to operate~     a switch.~   "
186960|NCT01117402|"~     Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix.~     However it is technically difficult to deliver adequate doses of RT due to presence of small~     intestines in the radiation area; thus disease control rates are poor and complication rates~     are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows~     for increasing dose to the tumor while sparing normal structures. It is expected that the use~     of a combination of IMRT & brachytherapy will achieve higher disease control rates and~     decrease the complication rates.~   "
188961|NCT01091142|"~     Primary objectives: To assess the safety and tolerability of ascending doses of NP001~     compared to placebo in subjects with ALS.~      Secondary objective: To explore the effects of NP001 on biomarkers potentially relevant to~     ALS.~   "
186936|NCT01117714|"~     About half of all lung cancers are caught after they have spread to nearby lymph nodes. Lymph~     nodes are small glands found throughout the body that remove bacteria and foreign particles~     (part of the immune system). A biopsy (tissue sample) can then be sent can be sent to the~     laboratory for testing. Biopsy results can determine if the cancer has spread (metastases)~     and to determine the best treatment for a patient with lung cancer.~      The purpose of this study is to develop a better way to detect lung cancer earlier before it~     spreads. This study compares the traditional mediastinoscopy/thoracoscopy surgery with the~     newer combined Endobronchial Ultrasound (EBUS) and Endoscopic Ultrasound (EUS) -guided fine~     needle aspiration (FNA) to see if either is better for this purpose. Traditional medical~     practice is to surgically open the chest and biopsy suspicious lymph nodes (called a~     mediastinoscopy/thoracoscopy). Some medical centers have already started combining the use of~     EUS plus EBUS as a standard practice for performing needle biopsy of lymph nodes in the chest~     to stage and treat lung cancer.~      Volunteers for this study have been diagnosed with known or suspected lung cancer, and will~     receive one of two choices to determine if their cancer has spread:~        1. Traditional Surgical Mediastinoscopy/Thoracoscopy Mediastinoscopy is a surgical~          procedure that allows physicians to view areas of the chest(including the heart,~          vessels, lymph nodes, trachea, esophagus, and thymus). An endotracheal (within the~          trachea) tube is inserted followed by a small incision (cut) in the chest. A~          mediastinoscope is inserted through the incision to see the organs inside the~          mediastinum and to collect tissue samples. Mediastinoscopy can be used to detect or~          stage cancer.~           Thoracoscopy is a surgical procedure that involves insertion of a thorascope through a~          very small incision in the chest wall. A thorascope is a thin, tube-like instrument with~          a light and lens which usually has a tool for removing tissue. This makes it possible to~          examine the lungs or other structures in the chest cavity, without making a large~          incision.~        2. EBUS combined with EUS-guided FNA EUS involves the use of a special endoscope fitted~          with an ultrasound processor at its tip. During EUS, images of surrounding lymph nodes~          can be obtained and a small needle can be guided through the esophagus into suspicious~          nodes to biopsy lymph nodes in the chest. Other research studies have shown that using~          EUS to guide needle biopsy of lymph nodes in the chest is equally if not more accurate~          than surgical biopsy. However, use of EUS for needle biopsy can limit what is seen by~          the physician and also limit the sampling of lymph nodes in front of the trachea. EBUS~          involves the use of a small ultrasound scope that is passed through the opening of the~          trachea and into the airways. EBUS combined with EUS is a less invasive procedure that~          provides full view of the lymph nodes in the chest area.~   "
186937|NCT01117701|"~     The purpose of this study is to investigate to forces needed to passage the ureteroscope up~     and down the ureter with and without a safety guidewire in place.~   "
186938|NCT01117688|"~     The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the~     results of ureteroscopy for urolithiasis.~      Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment~     of urolithiasis.~   "
186939|NCT01117675|"~     Background: Antiretroviral therapy has changed the natural history of the HIV infection in~     developed countries becoming a chronic disease. This clinical scenario would need a new~     approach to control patients, simplifying the follow-up visits and the accessibility to the~     healthcare professionals. A new home care model using a telemedicine system (Virtual~     Hospital) was developed.~   "
186940|NCT01117662|"~     Acute kidney allograft rejection is the major cause for a loss of graft function and has a~     negative impact on long-term graft survival. Anti-rejection therapy traditionally focuses on~     T cell-mediated mechanisms of renal allograft rejection. However, available agents that~     affect T-cell pathways have only little impact on long-term graft survival. There is~     increasing evidence that B-cells play an important role in acute transplant rejections. CD20+~     B cell infiltrates in acute T-cell mediated rejections are frequent and correlate with a~     worse response to conventional anti-rejection treatment and an increased risk of graft loss.~     In one pilot study, supported by several case reports, a beneficial effect of Rituximab for~     the treatment of acute rejection episodes with intrarenal B-cell infiltrates was shown.~     However, despite the promise of these observations solid evidence is required before~     incorporating this treatment option into a general treatment recommendation.~      In a multicenter randomized placebo controlled double blind phase III trial the investigators~     want to demonstrate that Rituximab in addition to standard treatment with steroid-boli is~     superior to the standard treatment alone regarding long-term kidney function. If the proposed~     study proves that Rituximab treatment of acute rejections is beneficial for the long-term~     allograft function, the conventional rejection therapy needs to be revised to this novel~     concept of B- cell targeting~   "
186941|NCT01117649|"~     The purpose of this study is to investigate the efficacy of target controlled fluid therapy~     with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in~     patients undergoing elective surgery of the pancreatic head. A third group receiving a~     balanced electrolyte solution (without colloidal volume replacement) will serve as a control~     for descriptive analysis.~   "
186942|NCT01117636|"~     The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of~     fast release aspirin tablets, 1000 mg (2 x 500 mg) compared to regular aspirin tablets, 1000~     mg (2 x 500 mg) and placebo in subjects with postsurgical dental pain.~   "
186943|NCT01117623|"~     Continuous dosing of BAY73-4506 in patients with advanced cancer~   "
186944|NCT01117610|"~     This prospective randomized study aims to evaluate the effectiveness of epidural injection of~     ropivacaine on the relief of pain in patients undergoing laminectomy.~      Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel~     number generation.~      Patients in group C will receive no medication intraoperatively, and patients in group I will~     receive epidural injection of 0.1% ropivacaine 10ml before skin incision.~      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients~     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at~     4,12,24,48 hour postoperatively.~   "
186945|NCT01117597|"~     The purpose of this study is to analyse a possible effect of radiofrequency (RF) fields used~     for Terrestrial Trunked Radio (TETRA) of brain activity and cognitive functions in~     occupationally exposed subjects.~   "
186946|NCT01117584|"~     Evaluate the efficacy, safety and tolerability of a 12-week treatment of 4 doses of ASP1941~     compared to placebo in combination with metformin in adult patients with Type 2 Diabetes~     Mellitus who have inadequate glycemic control on metformin alone.~   "
186947|NCT01117571|"~     Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20~     sites.The study sites will be located in the United States.The study objective is to evaluate~     the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in~     patients with single compartment osteoarthritis.~   "
186975|NCT01117181|"~     The Apathy in Dementia Methylphenidate Trial (ADMET) is a masked, placebo-controlled trial~     that will examine the efficacy and safety of methylphenidate for the treatment of clinically~     significant apathy in patients with Alzheimer's dementia.~   "
187009|NCT01116739|"~     An intensive intervention of specially trained paraprofessionals, called community oral~     health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish~     and oral health promotion education, compared to usual care, will reduce decayed, missing,~     and filled tooth surface measures at 2 years for children in American Indian Head Start~     Programs.~   "
186948|NCT01117558|"~     PCOS is the most common endocrine disorder in reproductive women. It is estimated that 5 to~     10% of women of reproductive age have PCOS. One of the major diagnostic criteria of PCOS was~     chronic anovulation which lead to irregular menstruation, amenorrhea, and infertility; the~     other diagnostic criteria was hyperandrogenism which lead to hirsutism, acne and alopecia.~     Furthermore, PCOS is thought as a metabolic disorder, the long-term consequence of PCOS were~     diabetes mellitus and cardiovascular disease, which are potentially dangerous in women~     health. Early diagnosis and prevention is very important to the PCOS patients.~      Obesity is the most potential risk of threat to health of populations. There is a major~     impact of obesity on the PCOS related disorders. Insulin resistance and distribution of~     adipose tissue were thought to be the important risk factors of cardiovascular and metabolic~     syndrome.~      To treat PCOS patients properly,Wan-Fang hospital had established a specific medical team.~     The investigators recently published in Fertility and Sterility about the clinical~     presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence in~     Taiwanese PCOS women than that previous reported in the Western women. It is important to~     know that some clinical presentation of PCOS might have ethic variance. Insulin resistance~     was reported as another candidate that might have ethic variance.The investigators had~     reported about 40% women in PCOS women were obese, it is similar with previous literature~     reported. Obesity is a major factor that could be controlled during the treatment of~     PCOS.Weight reduction is one of our methods in PCOS treatment. The progressive results for~     obese PCOS women would be facing the risks of diabetes and metabolic syndrome.The~     investigators thought like to evaluate the benefit of weight reduction program to the~     prognosis of obese women with PCOS. Furthermore, it is known that Endothelial progenitor~     cells (EPC) be an early marker of cardiovascular disease, the investigators would like to~     know the role of EPC to predict metabolic syndrome in women with PCOS. Wan-Fang hospital has~     a professional team in PCOS treatment and research which including gynecological~     endocrinologist, cardiologist, medical endocrinologist, specialist in weight reduction. This~     team had been working well for more that 4 years.~      The investigators hope that they can make a contribution to the study and treatment of PCOS~     in Taiwan.~   "
186949|NCT01117545|"~     EFT (Emotional Freedom Techniques) has been shown to significantly reduce post-traumatic~     stress disorder (PTSD) and other psychological symptoms such as anxiety and depression in a~     variety of clinical trials. This study examines the effect of a six session EFT protocol on~     the symptoms of veterans with clinical scores on the PTSD Checklist-Military (PCL-M).~     Subjects in the experimental group receive EFT coaching supplemental to, and supportive of,~     the usual care treatment provided by their primary care provider. Subjects in the wait list~     control group receive usual care for a month, with pre and posttests, after which they also~     receive the EFT coaching protocol. Subjects are followed at three month intervals to~     determine if gains are maintained, and whether the symptom reductions are similar to those~     observed in other trials of EFT.~   "
186950|NCT01117532|"~     Depression is an important mental health concern in college students. This study will recruit~     students who test positive for moderate to severe depression on the Beck Depression Inventory~     (BDI). Subjects will be randomly assigned to either a treatment or a control condition. Those~     in the treatment group will receive four 90 minute group classes using EFT (Emotional Freedom~     Techniques) to address traumatic memories and other self-identified causes of depression. It~     will compare them to a no treatment control group.~   "
186951|NCT01117519|"~     The purpose of this study is to determine whether the administration of a compound of~     balanced infusion solutions including 50% crystalloid and 50% colloid has a positive impact~     on acid-base balance in elective hip replacement surgery. The application of the study~     medication will be carried out through a goal-directed intraoperative therapy by~     transoesophageal doppler.~   "
186952|NCT01117506|"~     To validate the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay in~     subjects who are referred for the work-up of coronary artery disease. The study will evaluate~     the clinical utility of a gene expression test Corus CAD (Age, Sex, Gene Expression Score -~     ASGES) in subjects referred for myocardial perfusion imaging (MPI) work-up for suspected~     obstructive atherosclerotic coronary artery disease (CAD). The Corus CAD (ASGES) is a gene~     expression test that quantify the expression of multiple genes from circulating peripheral~     blood cells to detect the presence of clinically significant obstructive CAD in patients with~     chest pain.~   "
186953|NCT01117493|"~     The aim of this exploratory randomized controlled trial was to investigate the efficacy of a~     disease specific Expert Patient Programme compared to usual care in patients with~     bronchiectasis. Hypothesis: Disease specific EPP will increase self efficacy compared to~     usual care.~   "
186954|NCT01117480|"~     The purpose of this study is to evaluate the clinical effectiveness and safety of adalimumab~     as used in routine clinical practice in adult participants with moderate to severe rheumatoid~     arthritis (RA) in Canada.~   "
186955|NCT01117467|"~     Simulation is used to teach undergraduate and postgraduate healthcare professionals, however~     it is not known how best to use this resource. Using qualitative methods, this study aims to~     investigate how medical students learn during simulation scenarios and will compare students~     who are paired with peers with those who are solo during their scenarios. Video and audio~     data from simulations will be collected and analysed with anxiety and empathy questionnaire~     data and semi-structured interviews.~   "
186956|NCT01117454|"~     The purpose of this study is to test whether the addition of oral flecainide to standard~     therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard~     therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.~   "
186957|NCT01117441|"~     Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Giving more than~     one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating young patients with acute~     lymphoblastic leukemia (ALL).~      This trial is studying several different combination chemotherapy regimens to compare how~     well they work in treating young patients with ALL.~      Study objectives~      Primary study questions:~        -  Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or~          unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone marrow~          on day 15 <0.1% or with TEL/AML1-positive ALL (randomized study question R1): Can the~          daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a~          reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)?~        -  Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2): Can~          the clinical outcome be improved by protracted asparagine depletion achieved through~          application of intensified PEG-L-asparaginase during reintensification and early~          maintenance?~        -  High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can~          the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during~          Protocol IB?~      Secondary study questions:~        -  Standard risk (SR) patients identified by at least one sensitive marker: Is the clinical~          outcome comparable to that obtained in SR patients (identified with two sensitive~          markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of~          PEG-L-asparaginase instead of native E. coli L-ASP?~        -  T-ALL non-HR patients: Can the high level of outcome which was obtained for these~          patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of~          PEG-L-ASP instead of native E. coli L-ASP?~        -  HR patients with persisting high MRD levels despite the use of the HR blocks in the~          intensified consolidation phase MRD Non-Responders: Is it possible to improve the~          outcome and to achieve a further reduction of leukemic cell burden by administration of~          an innovative treatment schedule (DNX-FLA)?~        -  Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are~          asparaginase activity and asparaginase antibodies associated with development of~          allergic reactions, and do they have an effect on the outcome of the patients?~        -  What is the relative value of different methods of MRD monitoring in the definition of~          alternative stratification systems within a BFM-oriented protocol?~   "
186958|NCT01117428|"~     This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and~     consists of five parts.~   "
188962|NCT01091129|"~     The purpose of this study is to determine whether treatment by the miraDry System can safely~     reduce the severity of axillary hyperhidrosis (excessive underarm sweating).~   "
186961|NCT01117389|"~     This study will focus on the primary objectives:~        -  To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer~          survivors and an acquaintance control group.~        -  To describe the difference in HPV vaccination rate and HPV vaccination intent among~          preadolescent/adolescent females surviving childhood cancer and an acquaintance control~          group.~      This study will also focus on the secondary objectives:~        -  To examine sociodemographic, medical, and psychological differences between those who~          have/have not initiated HPV vaccination and between those who do/do not intend to get~          vaccinated in the future.~        -  To assess the general predictive influence of sociodemographic, medical, and~          psychological variables on HPV vaccination and intent among mothers with~          preadolescent/adolescent daughters.~   "
186962|NCT01117376|"~     42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are~     recruited. All patients enter a primary acetaminophen absorption test study as baseline.~     Serum levels of acetaminophen will be measured by florescence polarization method at~     15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen.~     Then the patients will be randomized to methylnaltrexone or erythromycin group.Another~     acetaminophen absorption test with the same schedule will be done after the last dose of each~     drug.The area under the curve for acetaminophen blood level will be used to compare the~     effect of two studied drugs on gastric emptying time.~   "
186963|NCT01117363|"~     Acute hunger-reducing effects (8h) has been documented for rye porridge breakfast compared~     with iso-caloric referenced refined wheat reference breakfast. The primary aim of the current~     study is to investigate whether this effects remains at regular consumption. A secondary aim~     is to compare the orocecal transit time (OCTT) between the two breakfasts.~   "
186964|NCT01117350|"~     Primary objective:~      To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of~     patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative~     period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents~      Secondary objectives of the comparative period (24 weeks):~      >To assess the effect of insulin glargine in comparison with liraglutide on:~        -  HbA1c level~        -  Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the~          comparative period~        -  Percentage of patients whose HbA1c has increased at the end of the comparative period~        -  Fasting Plasma Glucose (FPG)~        -  7-point Plasma Glucose (PG) profiles~        -  Hypoglycemia occurrence~        -  Body weight~        -  Adverse events~      Objectives of the extension period (24 weeks):~      >To assess the effect of insulin glargine in patients not adequately controlled with~     liraglutide on:~        -  HbA1c level~        -  FPG~        -  7-point PG profiles~        -  Hypoglycemia occurrence~        -  Body weight~        -  Adverse events~   "
186965|NCT01117337|"~     The purpose of the study is~        1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal~          hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia~        2. To test whether non-fixation of mesh leads to less pain compared to the repair when the~          mesh is fixed.~   "
186966|NCT01117324|"~     Bone density was found to be impaired among lage babies and infants of diabetic mothers as~     found in small group studies. The assumption is that large weight decreases fetal movements~     and causes decreased bone mineralization.The aim of the study is to compare 2 study groups -~     of large infants and infants of diabetic mothers to each other and to controls.~   "
186967|NCT01117311|"~     The overall aim of this application is to determine the mechanism(s) by which common~     bariatric surgical procedures alter carbohydrate metabolism. The study proposed will examine~     the effect of vagal nerve stimulation on insulin secretion and action.~   "
186968|NCT01117298|"~     Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many~     patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity~     and adversely affects the quality of life. In an earlier study, we have observed marked~     improvement in RP attacks and rapid healing of digital ulcers following therapy with~     phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study~     the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least~     one or more vasodilators.~   "
186969|NCT01117285|"~     The main purpose of this cluster randomized controlled trial is to evaluate the difference in~     effectiveness between a combined implementation strategy and an educational strategy on the~     implementation of a community occupational therapy program for clients with dementia and~     their primary caregivers.~   "
186970|NCT01117272|"~     Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder of reproductive-age~     women. According to Rotterdam 2003 criteria: at least two of three criteria are met,~     hyperandrogenism, chronic anovulation, and polycystic ovary. PCOS will cause irregular~     menstrual cycle, infertility, acne, hirsutism, obesity, or/and metabolic syndrome, diabetes~     that may increase risk of cardiovascular disease.~      Hyperprolactinaemia is also a common problem in reproductive aged women. Both~     hyperprolactinaemia and PCOS had endocrine disorder and irregular menstrual cycle.~     Investigators hope to collect clinical data from PCOS and prolactinemia patients followed in~     Wang Fang hospital for many years in endocrinological and metabolical aspects for comparison.~     Investigators at the same time would like to understand more about other similarities and~     differences between these two endocrinological dysfunction for future study.~   "
186971|NCT01117246|"~     This study is to confirm the safety and technical of MRI guided High Intensity Focused~     Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases.~      MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate~     tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue.~     The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be~     performed in patients who pass inclusion/exclusion criteria.~   "
186972|NCT01117233|"~     The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of~     PF-04427429 administered intravenously to healthy adult volunteers~   "
186973|NCT01117220|"~     The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective~     for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or~     Mixed).~   "
186974|NCT01117194|"~     The purpose is to study the effect of rehabilitation robot on shoulder training for stroke~     patients.~   "
186976|NCT01117168|"~     Background:~      - The Children s Oncology Group has established a research network, the Childhood Cancer~     Research Network (CCRN), to collect information about children with cancer and other~     conditions that are benign but involve abnormal cell growth in order to help doctors and~     scientists better understand childhood cancer. The CCRN's goal is to collect clinical~     information about every child diagnosed with cancer and similar conditions in the United~     States and Canada, to allow researchers to study patterns, characteristics, and causes of~     childhood cancer. The information can also help researchers study the causes of childhood~     cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be~     asked to provide information about themselves and their child for research purposes.~      Objectives:~        -  To obtain informed consent from parents (and the child, when appropriate) of infants,~          children, adolescents, and young adults newly diagnosed with cancer to enter their names~          and certain information concerning their child into the Childhood Cancer Research~          Network.~        -  To obtain informed consent from parents (and the child, when appropriate) of infants,~          children, adolescents, and young adults newly diagnosed with cancer for permission to be~          contacted in the future to consider participating in non-therapeutic and prevention~          research studies involving the parents and/or the child.~      Eligibility:~      - Parents of children who have been seen at or treated by a hospital that is a member of the~     Children s Oncology Group.~      Design:~        -  Parents will provide permission to have personal information sent from their child s~          hospital to the CCRN, including the child and parents' names; child's gender, birth~          date, race, and ethnicity; information about the disease; and the treating institution.~        -  Parents will also give permission for CCRN to contact the diagnostic laboratory to~          obtain specific information about the tumor or cancer cells.~        -  Parents will be asked if they are willing to be contacted in the future to consider~          participating in CCRN research studies, and will provide contact information (name, home~          address, and telephone number) to be entered in the CCRN.~        -  Parents or patients who change their minds about having information available in the~          CCRN can ask the treatment institution to restrict access to the identifying~          information. Parents or patients who refuse to have information included in the CCRN or~          be contacted in the future will still be able to enter clinical cancer research studies.~   "
186977|NCT01117155|"~     Background:~        -  Children with brain tumors often have magnetic resonance imaging (MRI) scans to see if~          the tumor has responded to therapy or to see if the tumor has grown. Sometimes, it is~          difficult to tell if the scan is abnormal because of tumor size or shape, swelling, scar~          tissue, or dead tissue. Because brain tumor biopsies require surgery, researchers are~          looking for more noninvasive ways of evaluating brain tumors.~        -  Positron emission tomography (PET) scans use a radioactive sugar known as 18F-FDG to try~          to determine if a tumor is active or not. Active tumors generally take up more sugar~          than the surrounding tissue, but because normal brain tissue uses the same sugar as~          brain tumors, it is then difficult to tell if tumor tissue is taking up sugar or not. A~          different radioactive agent, 18F-FLT, is now being studied in some adults with different~          kinds of tumors. Researchers are interested in determining whether it is possible to use~          this agent as a marker of tumor activity in children.~      Objectives:~        -  To determine the safety and effectiveness of 18F-FLT for pediatric glioma scans.~        -  To compare the results of 18F-FLT studies with studies using the radioactive agents~          18F-FDG and 1H-MRSI.~      Eligibility:~      - Children less than 18 years of age who are having radiation therapy to treat malignant~     gliomas.~      Design:~        -  Participants will have scanning tests before radiation therapy, 1 to 3 weeks after~          radiation therapy, and if researchers suspect that the tumor is growing.~        -  This study will involve three separate imaging tests (1H-MRSI, 18F-FDG PET, and 18F-FLT~          PET).~        -  Proton spectroscopy (1H-MRSI) is a procedure that is similar to MRI and is performed in~          the same scanner as an MRI. Because this scan is long (2-3 hours), most children will~          receive medications from an anesthesiologist so that they can sleep through the~          procedure.~        -  Within 2 weeks of the 1H-MRSI scan, participants will have the PET scans with both the~          standard contrast agent (18F-FDG) and the experimental agent (18F-FLT). These scans will~          last approximately 1 hour each.~   "
186978|NCT01117142|"~     Background:~        -  Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell~          lymphoma (MCL) are types of cancers in which there are too many abnormal lymphocytes (a~          type of white blood cell). Monoclonal B-cell lymphocytosis (MBL) is a condition in which~          the individual has a larger than normal number of lymphocytes. Individuals with CLL,~          SLL, MBL, and MCL may survive for many years without the need for treatment, but there~          is an apparent correlation between cell birth rates and disease activity. By studying~          the birth and death rates of lymphocytes, researchers hope to identify individuals who~          are at risk for worsening disease.~        -  Heavy water is similar in structure to regular water, but it has two deuterium atoms~          instead of two hydrogen atoms. Deuterium has one more neutron than hydrogen, which is~          what makes heavy water heavy. Heavy water is not radioactive, looks and tastes like~          regular water, and has no known harmful effects at research-level doses. When a small~          amount of heavy water is consumed daily, newly produced blood cells are labeled~          (tagged), which allows researchers to track cell growth and to measure the birth and~          death rates of CLL, SLL, MBL, MCL or normal lymphocytes.~      Objectives:~      - To study the birth and death rates of lymphocytes from individuals with MBL, CLL/SLL, and~     MCL, compared with lymphocytes from healthy volunteers.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with MBL, CLL, SLL, or MCL,~          but who have not been taking certain agents (Viagra, Levitra, Cialis, or other~          PDE-inhibitors, prednisone, cyclosporin-A, rapamycin, or other immunosuppressive agents,~          more than 2 cups of green tea daily, or Celebrex) for 4 weeks prior to enrollment in the~          study.~        -  Healthy volunteers at least 18 years of age, but who have not been taking certain agents~          (Viagra, Levitra, Cialis, or other PDE-inhibitors, prednisone, cyclosporin-A, rapamycin,~          or other immunosuppressive agents, more than 2 cups of green tea daily, or Celebrex)for~          4 weeks prior to enrollment in the study.~      Design:~        -  Participants will be screened with a medical history, physical examination, and initial~          blood tests. Other tests may be administered to the individuals with cancer, as required~          by the study researchers.~        -  All participants will drink regular doses of heavy water daily for a total of 4 weeks~          (labeling period). There is an optional 6-month follow-up or wash-out period during~          which no additional heavy water will be consumed.~        -  Blood samples will be collected weekly during the labeling period, and a bone marrow~          biopsy will be obtained where possible. Individuals with cancer may also have a lymph~          node biopsy during this part of the study.~        -  Additional blood samples may be collected during the optional wash-out phase of the~          study to determine the rate at which cancer cells disappear.~        -  Treatment is not provided as part of this protocol.~   "
186979|NCT01117129|"~     This randomized, double-blind, placebo controlled, parallel group study will assess the~     efficacy and safety of rituximab [MabThera/Rituxan] in patients with severe active rheumatoid~     arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging~     (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2~     intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B).~     All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating~     clinical response at week 24 may receive further cycles of MabThera, patients in group B~     without clinical response will also be treated with active MabThera. Anticipated time on~     study treatment is up to 2 years. Target sample size is <50 patients.~   "
186980|NCT01117116|"~     The purpose of this study is to look at whether Advair® and SYMBICORT® have different effects~     on airway constriction by means of methacholine challenge testing.~   "
186981|NCT01117103|"~     This was an observational, prospective, multicentric study conducted in a cohort of subjects~     with type 2 diabetes and prescribed with Glucophage XR therapy from hospitals or clinics in~     Hong Kong, Indonesia, Korea, Malaysia, Philippines and Singapore. Glucophage XR is being used~     in the Asia Pacific region for the treatment of subjects with type 2 diabetes. This study was~     designed to provide information on the day to-day experience of using Glucophage XR in the~     management of subjects with type 2 diabetes and its use in routine clinical practice in Asia~     Pacific region.~   "
186982|NCT01117090|"~     The purpose of this study is to record signatures from the fluid surrounding the spinal cord~     from people who have an implanted drug infusion system.~   "
186996|NCT01116908|"~     The purpose of this study is to assess whether children under 2 years and other members of~     households in which HIV-positive mothers are providing replacement and complementary feeding~     would potentially benefit from the use of a filter designed to eliminate microbial pathogens~     from drinking water at the household level.~   "
186997|NCT01116895|"~     An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo~     controlled, parallel group study with 12 weeks once daily oral treatment in subjects with~     psoriasis vulgaris.~   "
186998|NCT01116882|"~     The primary objective of the trial is to compare the acute safety and long term outcomes~     between hospitals with cardiac surgery on-site (SOS hospitals) and hospitals without cardiac~     surgery on-site (non-SOS hospitals) for patients with ischemic heart disease treated with~     elective percutaneous coronary intervention (PCI) (stable angina, acute coronary syndrome, or~     non-Q wave MI) presenting to non-SOS hospitals.~   "
186983|NCT01117077|"~     Infection accounted for the first cause of death in patients after liver transplantation, and~     2 / 3 of the cause of death was fungal infections. The investigators group early found that T~     cell subsets playing a role of inducing immune tolerance were significantly increased in vivo~     of liver transplantation patients with aspergillus infection, which may be a kind of Treg~     cells expressing IL-17. To explore the immune tolerance mechanism induced by the immune~     balance cells is important to liver transplantation patients for improving efficacy and~     reducing the mortality. Therefore, the investigators are going to get the blood sample and~     liver tissue of the liver transplantation patients before and after treatment of aspergillus~     infection, flow cytometry analysis of blood T cell subsets, Cytometric Bead Array to detect~     changes in blood cytokines, laser capture microdissection to obtain liver biopsies of~     inflammatory cells in portal area and further for analysis of T cell subsets and protein. And~     the investigators are also to investigate the characteristics of CCR6 + CD4 + FOXP3 + Treg~     cell clones secreting IL-17 and the capacity of which suppressing conventional T cell~     proliferation. This study may find new methods, such as certain types of T cell subsets or~     cytokines for the treatment of liver transplant patients, which not only to anti-rejection~     but also to reduce fungal infection.~   "
186984|NCT01117064|"~     We are looking to test a novel device in the treatment of Obstructive Sleep Apnea (OSA).~     Rather than using positive pressure to open the airways, we are testing a device that~     delivers an auditory tone to affect neuromodulation. We will test its efficacy in treating~     OSA while minimizing sleep disturbance. As this device is much less cumbersome to wear, we~     hope this therapy device will also improve compliance with treatment.~   "
186985|NCT01117051|"~     The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks~     of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from~     opioid induced constipation.~   "
186986|NCT01117038|"~     The purpose of this study is to determine the change in the blood pressure and pulse rate,~     pharmacokinetics and the safety when avanafil is taken with either enalapril or amlodipine.~   "
186987|NCT01117025|"~     The purpose of this study is the comparative evaluation of systolic blood pressure (SBP)~     lowering, atrial fibrillation (AF) recurrence and clinical data in patients with~     paroxysmal/persistent AF and resistant hypertension, undergoing AF ablation alone or combined~     with percutaneous renal denervation.~   "
186988|NCT01117012|"~     The primary objective of the study was to evaluate the safety of long-term VX-770 treatment~     in participants with cystic fibrosis (CF). The secondary objective of the study was to~     evaluate the efficacy of long-term VX-770 treatment in subjects with CF.~   "
186989|NCT01116999|"~     The investigators hypothesise that, for novices, light guided tracheal intubation will~     improve the time and success rate of this clinical skill compared to standard direct tracheal~     intubation.~   "
186990|NCT01116986|"~     The goal of this research is to identify the best smoking cessation intervention components~     to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This~     research examines the ability of different interventions, provided both prior to and after~     the quit attempt, to maximize the ability to initially quit and then stay quit. The~     investigators will be examining six different treatment interventions: pre-quit nicotine~     patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit~     phone counseling and duration of post-quit nicotine replacement therapy.~   "
186991|NCT01116973|"~     The purpose of this study is to compare CVP measurements from CICCs and PICCs. The~     investigators will also evaluate whether or not the duration of CICC placement affects the~     differences in CVP measurements between the CICCs and PICCs. The investigators hypothesize~     that the differences between the CVP measurements of the CICCs and PICCs will be clinically~     insignificant.~   "
186992|NCT01116960|"~     The investigators hypothesize that common objections to P4P relate to potential loss of~     autonomy or concerns about adverse effects on patient care.~   "
186993|NCT01116947|"~     Protein-energy wasting, as reflected by a serum albumin <4.0 g/dL, is very common in~     maintenance hemodialysis (MHD) patients and associated with poor clinical outcomes including~     high death rates. Hyperphosphatemia, reflected by serum phosphorus level >5.5 mg/dL, is also~     common disorder and associated with increased death risk in the same population. The~     traditional dietary intervention to control hyperphosphatemia is to restrict protein intake.~     This, however, may worsen protein-energy wasting as recently showed in large epidemiologic~     data, which indicated that the best survival was observed in MHD patients with increased~     protein intake while serum phosphorus could be controlled. We hypothesize that the provision~     of high protein diet will be possible if a potent phosphorus binder (Fosreonl™) will be~     prescribed simultaneously. Hence, we propose to conduct a randomized controlled trial in 110~     hypoalbuminemic (albumin <4.0 mg/dL) MHD patients in several DaVita dialysis facilities in~     Los Angeles South Bay area. After 1:1 randomization, we will provide the participating~     subjects (the INTERVENTION group) with 8 weeks of high protein meals in form of prepared meal~     boxes (50 g protein, 850 Cal, and a phosphorus to protein ratio of <10 mg/gm) during each~     hemodialysis treatment, along with 0.5 to 1.5 g Fosrenol, to be titrated if necessary; as~     well as dietary counselling to maintain a high dietary protein intake at home (with same or~     similar binder regimen) for 8 weeks and to avoid food items with high phosphorus based~     additives. Meals will be prepared at Harbor-UCLA GCRC Bio-nutrition Department. We have~     reviewed and tested the feasibility of meal preparation and distribution system and the~     related logistics. The CONTROL group will also receive meal boxes but the meal contains low~     Calorie (<50 Cal) and almost zero protein (<1 g) diet (such as salads) during each~     hemodialysis treatment. These patients will continue their pre-existing phosphorus control~     regimens. As outcome variables, we will examine change in serum albumin over the 8 weeks of~     intervention. We will also examine changes in dietary protein and serum phosphorus in the 2~     groups after 8 weeks of intervention. Quality of life and patient satisfaction will also be~     examined before and towards the end of the intervention phase. Given our ongoing 2-year study~     with a similar operation known as the AIONID Study and given DaVita dieticians''~     collaboration and support, we anticipate successful recruitment, retention and data analyses~     within 8 to 12 months.~   "
186994|NCT01116934|"~     Papillon-Lefèvre syndrome (PLS) is characterised by aggressively progressive periodontitis~     combined with palmo-plantar hyperkeratosis. It is caused by loss of function mutations in~     the cathepsin C gene. The hypothesis behind this study is that PLS patients' PMNs produce~     more proinflammatory cytokines to compensate for their reduced capacity to neutralize~     leukotoxin and to eliminate Aggregatibacter actinomycetemcomitans. Production of more~     interleukin (IL)-8 would result in the attraction of more PMNs. Thus, the aim of this study~     was to evaluate the cytokine profile in PLS patients' blood cultures.~   "
186995|NCT01116921|"~     The primary objective of this research is to compare the need for intubation and mechanical~     ventilation in the first seven days of life for infants with respiratory distress syndrome~     (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a~     Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive~     surfactant.~   "
186999|NCT01116869|"~     The study is designed to confirm the current indication (below) of the CellSearch®~     Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in~     China.~      The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating~     tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+)~     in whole blood.~      The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor~     Cell Kit, is associated with decreased progression free survival and decreased overall~     survival in patients treated for metastatic breast cancer. This test is to be used as an aid~     in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be~     used in conjunction with other clinical methods for monitoring metastatic breast cancer.~     Evaluation of CTC at any time during the course of disease allows assessment of patient~     prognosis and is predictive of progression free survival and overall survival.~   "
187000|NCT01116856|"~     At the present time, scientific consensus exists on obesity multifactorial etiopatogenia. As~     well, professionals and researchers agree that the treatment must approach several scopes,~     such as dietetic, physical activity, pharmacologic and surgical. These two last ones should~     not be the first election and must be reserved for those cases of morbid obesities or in case~     the previous ones have failed. The combination of diet and exercise is still not sufficiently~     studied, in special, the addition of strength training, as we propose in this project, for~     which established intervention protocols do not exist, and that could suppose an additional~     benefit in the reduction of risk factors.~      Therefore, the objectives that we aim in this project are enumerated below:~        -  To discover which are the most effective training protocols and to determine what type~          of exercise combined with nutrition is more appropriate for obesity intervention~          programs.~        -  To establish the relationship between markers related with cardiovascular risk~          (adopokines and lipid profile) and the different intervention protocols proposed.~        -  To describe the influence of nine genetic polymorphisms (selected by their relationship~          with the energy expense and the physical yield) on the effect of different training~          protocols.~        -  To determine how important is body composition (fat mass and muscle mass mainly) in~          total daily energy expenditure.~        -  To establish rules of nutritional and exercise intervention that can be applied in~          public and private training centers. If the proposed objectives are fulfilled, this~          would contribute to an improvement in patients health in long term, along with an~          enormous saving in public health. Therefore, the purpose of this project is to propose~          new lines of intervention in overweight and obese adults that, until now, little have~          been investigated. This way, resistance training is proposed in combination with~          cardiovascular training and endocrinologic treatment. It fits to emphasize that, as far~          as we know, it is the first project of these characteristics, that puts in touch the~          public and private sector (hospitals, universities and fitness area), to establish~          standardized relations protocols to allow a close pursuit of obese patients.~   "
187001|NCT01116843|"~     The objective of this study is to assess the biological effects in the primary tumor~     following a short, pre-operative course of treatment with PF-00298804 in patients with Oral~     Cavity Cancer.~   "
187002|NCT01116830|"~     This randomized, double-blind, placebo-controlled parallel group study will assess the effect~     on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of~     RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will~     be randomized to receive either RO4917838 (10 milligrams [mg] daily orally) or placebo for 6~     weeks, in addition to their stable antipsychotic medication. Anticipated time on study~     treatment is 6 weeks.~   "
187003|NCT01116817|"~     The aim of this study is to describe and compare the percentage of patients infected by HIV-1~     to maintain a complete virology suppression at the CSF (CSF CV 1 copy / mL) in patients with~     CV <50 copies / mL and treated with stable antiretroviral therapy for at least 3 years with~     LPV / r 400/100 mg twice daily + 2 NRTI.~   "
187004|NCT01116804|"~     Present imaging modalities for primary liver cancer (hepatocellular carcinoma or HCC) have~     several shortcomings. One important shortcoming is the time delay between successful~     treatment and radiological confirmation of this response. Often it takes several months for~     anatomical changes to occur and to be appreciated on morphological imaging such as CT or MRI~     (shrinkage of tumor, absence of contrast enhancement). Functional imaging by means of~     Fluor-18 deoxyglucose or Fluor-18 Choline (positron emitters, PET-scan) might be an early~     indicator of response. This early information might help to tailor treatment. For instance,~     if no response is induced, an early switch in therapy can be planned.~      The present study investigates whether the routine PET-tracer (Fluor-18 deoxyglucose) and the~     experimental PET-tracer, Fluor-18 Choline help to predict response if a patient with~     inoperable primary liver cancer is treated (radionuclide therapy, biologicals).~   "
187005|NCT01116791|"~     The majority of patients with upper gastrointestinal cancer, such as gastric, biliary, or~     pancreatic carcinoma, present with metastatic disease, and have an extremely poor survival,~     irrespective the type of treatment modality. The aim of the current monocentric phase II~     study is to evaluate in these patients the effectiveness of cytoreductive surgery (CRS) plus~     hyperthermic intraoperative peritoneal chemotherapy with cisplatin (HIPC). The study is~     designed to have at least 80% power to detect a 40% increase in 1-year overall survival~     common to all strata (gastric-biliary-pancreas) after CRS+HIPC. Over an anticipated period of~     2 years, 60 patients will undergo CRS + HIPC. Translational research will quantify~     perioperative circulating and peritoneal tumour cells, based on real-time RT-PCR for CEA and~     EpCAM. Plasma concentration of cytokines will be determined for IL-1β, IL-2, IL-6, IL-8,~     IL-10, IL-12p70, IL-13, IFN-γ, and VEGF at several time-points. Systemic immunological~     changes will be assessed by flow cytometric quantification of the relative proportions and~     absolute numbers of B- and T-lymphocytes, NK cells, effector T cells, HLA-DR+ T cells, and~     regulatory T cells. Gene-expression studies will be performed using Affymetrix HG U133 Plus~     2.0 arrays on primary and metastatic tissue samples.~   "
187006|NCT01116778|"~     The purpose of this study is to evaluate the efficacy and safety of probiotics eN-Lac®~     capsules (Lactobacillus paracasei GMNL-32) for the treatment of children with perennial~     allergic rhinitis(PAR).~   "
187007|NCT01116765|"~     To assess whether an oral stimulation program, before the introduction of oral feeding,~     enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or~     apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to~     29 weeks of gestation age.~   "
187008|NCT01116752|"~     The primary goal of this project is to determine whether normalizing hyperglycemia is a safe~     approach to improve multisystem organ function in critically ill children requiring intensive~     care. The will are conducting the PedETrol (the Pediatric ICUs at Emory-Children's Center~     Glycemic Control: The PedETrol Trial) Trial, a 4-year single-center, prospective, randomized~     clinical trial to evaluate the outcome benefit, safety and resource utilization impact of~     maintaining strict glucose control in children with life-threatening conditions.~      ***This study is supported by an Research Project Grant (RO1 grant) (MRR) via the National~     Heart, Lung, and Blood Institute (NHLBI).~   "
187011|NCT01116713|"~     Postoperative pain, nausea and vomiting (PONV) are the most common complications after~     anesthesia and surgery. Women undergoing mastectomy with axillary dissection are at a~     particularly high risk for the development of PONV and an incidence of 60-80% in patients~     receiving no antiemetic has been reported. Emetic episodes predispose to aspiration of~     gastric contents, wound dehiscence, psychological distress, and delayed recovery and~     discharge times. These justify the use of prophylactic antiemetics in women scheduled for~     mastectomy. Most of the currently used antiemetics, including antihistamines, butyrophenones~     and dopamine receptor antagonists have been reported to cause occasional undesirable adverse~     effects, such as excessive sedation, hypotension, dry mouth, dysphoria, hallucinations and~     extrapyramidal signs. Antiserotonins (e.g., ondansetron) are available for the prevention and~     treatment of PONV in patients undergoing various types of surgery [4]. However, the use of~     prophylactic antiemetic therapy with antiserotonins has been criticized for being too~     expensive.~      Dexamethasone was first reported to be an effective antiemetic regimen in patients receiving~     cancer chemotherapy.~      The purpose of this study was to evaluate the efficacy of dexamethasone treatment for~     reducing pain and PONV as well as analgesic and antiemetic requirements in women undergoing~     general anesthesia for mastectomy with axillary lymph node dissection.~   "
187012|NCT01116700|"~     Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique~     properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical~     patients frequently come to the operating room on anticonvulsant therapy with a history of~     seizures. The investigators clinical experience suggests that these patients are resistant to~     the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic~     interaction between the anticonvulsant medications and dexmedetomidine or the higher~     dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the~     underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic~     and pharmacodynamic differences of dexmedetomidine between patients receiving and not~     receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for~     these differences.~   "
187013|NCT01116687|"~     This phase II trial studies how well RO4929097 works in treating patients with metastatic~     colorectal cancer. RO4929097 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
187014|NCT01116674|"~     The objective in this project is to assemble a consortium of pediatric critical care centers~     of varying size, acuity, and composition to evaluate our glycemic control protocol on at~     least 250 children with hyperglycemia in different critical care units.~      ***This Study is supported by an R21 Grant (MRR) from the National Institute of Diabetes and~     Digestive and Kidney Diseases (NIDDK).~   "
187015|NCT01116661|"~     The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular~     accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On~     imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting~     in the surgeon being better able to visualize and thus able to make a complete, or~     near-complete resection of the tumor.~   "
187016|NCT01116648|"~     This partially randomized phase I/II trial studies the side effects and the best dose of~     cediranib maleate and olaparib and to see how well they work compared to olaparib alone in~     treating patients with ovarian, fallopian tube, peritoneal, or triple-negative breast cancer~     that has returned after a period of improvement. Cediranib maleate may help keep cancer cells~     from growing by affecting their blood supply. Olaparib may stop cancer cells from growing~     abnormally. The combination of cediranib maleate and olaparib may help to keep cancer from~     growing.~   "
187017|NCT01116635|"~     The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when~     loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The~     study will treat patients with surgically resectable liver cancers with varying doses of~     doxorubicin loaded into microspheres, with a close review of any side effects and~     chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after~     at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor~     destroyed. It is hoped that the study results will determine if this treatment has a role in~     controlling tumor growth prior to surgical removal.~   "
187018|NCT01116622|"~     Primary objective: To determine the Phase II doses and to evaluate the safety of~     administering bexarotene (Targretin®) daily in combination with oral erlotinib (Tarceva™) to~     patients with advanced aerodigestive tract cancers.~      Secondary objectives: To evaluate the response rates, progression-free survival and overall~     survival of patients with advanced aerodigestive tract cancers treated with bexarotene~     (Targretin®) in combination with erlotinib (Tarceva™). To investigate the activity of this~     targeted combination therapy by evaluating changes in molecular markers from pre- and~     post-treatment buccal swab samples.~   "
187019|NCT01116609|"~     The purpose of this study is to define the local metabolic effects of epinephrine in the~     bilaterally perfused human leg.~   "
187020|NCT01116596|"~     Paracetamol is one of the most widely used analgesics in the world especially for chronic~     pain in the elderly. The metabolism of paracetamol occurs in the liver and involves the use~     of glutamyl-cysteinyl-glycine (Glutathione (GSH)). Medications such as paracetamol, may~     reduce the reserves of GSH because it is used for detoxification and elimination. It is well~     known that the concentration of GSH decrease after administration of paracetamol in humans~     and animals.~      Aging is associated with decreased concentration of GSH in cells and tissues. In the elderly,~     a decrease of GSH concentration in plasma or red blood cells is associated with decreased~     physical and mental health.~      We wish here to determine, in subjects aged over 70 years, the blood concentration of~     glutathione (GSH) and urinary loss of cysteine in the detoxification of paracetamol, when~     taking paracetamol treatment repeated.~   "
187048|NCT01116232|"~     This Phase II clinical trial was designed for patients with hematologic malignancies in need~     of donor peripheral blood stem cell transplant, and have no HLA matched donor. Therefore It~     will test the efficacy of combining sirolimus, tacrolimus, antithymocyte globulin, and~     rituximab in preventing graft versus host disease in transplants from HLA Haploidentical and~     partially mismatched donors.~   "
187317|NCT01112709|"~     The aim of this Phase II Clinical Trial is to demonstrate the efficacy of social cognitive~     theory (SCT) based intervention for initiating, and most importantly, maintaining resistance~     training in older adults with pre-diabetes (i.e., impaired glucose tolerance or impaired~     fasting glucose) to improve blood glucose regulation.~   "
187021|NCT01116583|"~     The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural~     analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain~     quality and whether or not gabapentin prevents the development of chronic pain conditions~     following thoracotomy.~      The main hypothesis is that gabapentin reduces the proportion of patients who develop a~     persistent pain condition following thoracotomy from 50% to 20%.~      Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point~     numerical rating scale, usage of epidural infusions of local and/or opioid analgesics,~     morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related~     side-effects.~      In addition gabapentin is expected to improve postoperative recovery by means of~     postoperative lung function, walking ability, health related quality of life and patient~     satisfaction~   "
187022|NCT01116570|"~     It is now accepted that physical activity is not deleterious in myopathies, including~     muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD),~     aerobic training has been reported to be associated to physiological and functional positive~     effects without alteration in quality of life. The review papers from Van der Kooi et al.~     (2005), Cup et al. (2007) and Féasson et al. (2010) suggest that the combination of endurance~     and strength training is even more relevant. Only a few controlled and randomized studies~     have been conducted on this topic. The impact of such training programs on the skeletal~     muscle regenerative capacities has not been yet addressed. Moreover, due to the fact that~     training programs are mainly performed on short-term supervised periods, there is a lack of~     knowledge regarding long-term effects, patient's autonomy and whether or not regular exercise~     practice can be maintained in patient's daily life. Also, only a few experiments have~     reported an integrative view of the potential benefits of such programs on functional,~     biological and quality of life.~   "
187023|NCT01116557|"~     The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3~     system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation~     Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.~   "
187024|NCT01116544|"~     The purpose of this study is to determine if individuals who had a stroke more than one year~     before entering the study and who remain unable to open their affected hand are better able~     to sense and move their affected arm after 10-15 weeks of treatment with a new robotic~     therapy device (the AMES device) and EMG biofeedback.~   "
187025|NCT01116531|"~     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and~     neuropathic pain. Treatment of neuropathic pain often requires a combination of pain~     medications due to the complex nature of neuropathic pain and frequent inadequate response to~     drug treatment. Common drugs used concomitantly with tramadol are SNRI antidepressant~     duloxetine and anticonvulsants such as pregabalin. Both tramadol and duloxetine have~     serotonergic effects and duloxetine has also a potential to inhibit metabolism of tramadol.~     The objective of the study is to investigate the pharmacokinetics and pharmacodynamic~     interaction of oral tramadol with duloxetine and pregabalin in patients with chronic~     neuropathic pain due to postherpetic neuralgia or diabetic polyneuropathy. All subjects will~     receive tramadol and duloxetine or tramadol and pregabalin in a randomized double-blind~     order. Primary end point is O-desmethyltramadol concentration.~   "
187026|NCT01116518|"~     The purpose of the investigators study is to compare the effect of: 1) physiotherapy 2)~     arthroscopic acromioplasty and debridement or 3) arthroscopic rotator cuff reconstruction and~     acromioplasty in the treatment of degenerative, atraumatic rotator cuff rupture.~   "
187027|NCT01116505|"~     The main purpose of this study is to evaluate the natural history of celiac disease in~     asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects~     of an intervention with a gluten-free diet. The investigators hypothesize that these subjects~     may have decreased general health and benefit of the dietary treatment regardless of the~     small-bowel mucosal structure.~   "
187028|NCT01116492|"~     This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy~     vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in~     SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic~     cholecystectomy.~   "
187029|NCT01116479|"~     This an open two-arm interventional randomised feasibility study in anaemic patients treated~     with chemotherapy. Randomisation is performed between two transfusion thresholds: Haemoglobin~     < 6.0 mmol/l (9.9 g/dL) versus haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l~     (13.4 g/dL) for males.Primary end-point is quality of life~   "
187030|NCT01116466|"~     The objective of this study is to evaluate the efficacy and safety of surgical procedure~     involving ActiGait - implantable drop foot stimulator.~   "
187031|NCT01116453|"~     Since there is unsatisfactory effect by currently pharmacologic therapies and preventive~     strategies for dysmenorrhea, this study is designed to evaluate the efficacy and quality of~     life of acupuncture for patients with dysmenorrhea based on the theory of traditional Chinese~     Medicine.~   "
187032|NCT01116440|"~     The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics~     of multiple doses of BGS649 with concurrent daily administration of combined oral~     contraception in patients with refractory endometriosis~   "
187033|NCT01116427|"~     The ACCLAIM study is testing whether the medication abatacept can be of benefit to patients~     with relapsing-remitting multiple sclerosis (MS). Although abatacept is an investigational~     medication for MS, it is not a new drug. Abatacept has been approved by the FDA to treat~     rheumatoid arthritis.~   "
187034|NCT01116414|"~     The purpose of this study is to develop an integrated view of molecular mechanisms underlying~     CF lung disease severity.~   "
187035|NCT01116401|"~     We plan to enroll premenopausal women in a trial investigating the impact of hot flashes~     developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa),~     leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to~     mimic the menopause transition. We will collect data on sleep disruption and mood changes to~     assess their relationship to the development of hot flashes.~   "
187086|NCT01115712|"~     The purpose of this study is to evaluate whether 30 mg of pioglitazone administered once~     daily for up to 28 days to healthy overweight and obese subjects will lead to a significant~     change in insulin sensitivity, measured in the setting of a hyperinsulinemic euglycemic clamp~   "
187036|NCT01116388|"~     Doctors at MassGeneral Hospital for Children (MGHfC) are doing a research study to learn if a~     gluten free-dairy free (GFCF) diet is helpful in improving gastrointestinal symptoms~     associated with autism.~      Hypothesis: The gluten free/casein free diet (GFCF) will result in a higher proportion of~     subjects having reduction in gastrointestinal (GI) symptoms associated with autism spectrum~     disorders (ASD).~      Primary Study Objective:~        -  To assess the effect of a GFCF diet on GI symptoms associated with ASD.~      Secondary Objectives:~        -  To assess if improvements in GI symptoms result in improvements in autistic behavior~          when using a GFCF diet in the dietary management of GI symptoms associated with ASD~        -  To determine the nutritional impact of a GFCF restrictive diet~        -  To assess the role of food allergies in the manifestation of GI symptoms~      This is a 14-week study that requires between 5 & 9 office visits. All study related~     activities -including physical exams, blood samples and allergy testing - and an amino acid~     based supplement drink, are at no cost. Research study visits will take place at MGHfC in~     Boston, or at Newton Wellesley Hospital in Newton, or at Lurie Center/LADDERS in Lexington.~   "
187037|NCT01116375|"~     To determine whether, in obese children with moderate-severe Obstructive Sleep Apnea who are~     prescribed Positive Airway Pressure(PAP) therapy, increased hours of PAP usage per night over~     a one-year period is associated with a greater improvement in HOMA-IR~   "
187038|NCT01116362|"~     The purpose of this study is to determine which surgical approach is better for clean~     transection injury in peripheral nerves in outcomes.~   "
187039|NCT01116349|"~     The fracture of the humeral diaphysis is a condition that represents 2% of all fractures. The~     conservative treatment of diaphyseal fractures of the humerus has long been considered the~     only option and the surgical treatment was primarily reserved for displaced fractures with no~     contact of bone ends. However, for a few years there has been an upsurge of indications for~     the surgical treatment of diaphyseal fractures.~      The purpose of this study is to compare the functional outcomes and the quality of life of~     surgically treated patients versus those who undergo a conservative treatment.~   "
187040|NCT01116336|"~     The purpose of this study is to test the preventive effects of a combination of drugs:~     polyphenon E (PPE) derived from green tea extracts, and erlotinib. Because this combination~     of drugs has not been tested in humans before for the prevention of cancer, it is not clear~     which dose of each agent will be optimal in combination.~      We will test the safety of the combination of PPE and erlotinib and see what effects (good~     and/or bad) it has on the patient's premalignant lesion, and find the highest dose of each~     agent that can be given in combination without causing severe side effects.~   "
187041|NCT01116323|"~     Since the report To Err is Human by the Institute of Medicine (IOM) in 1999, attention was~     brought to the general public that adverse events in medicine are common and are one of the~     leading causes of morbidity and mortality within the United States. The report estimates that~     44,000 - 98,000 patients hospitalized in the United States die each year as a result of~     medical errors.~      In spite of the growing patient safety movement worldwide, health care has not become~     measurably safer. Health care is one of the few risk-prone areas in which public demand~     limits the use of common-sense safety-enhancing solutions, such as limiting the flow and~     choosing the type of incoming patients. The latter is especially true for emergency~     departments (EDs) since they deliver an important public service by providing emergency care~     24 hours a day, 365 days per year, without discrimination by social or economic status. One~     of the key expectations of EDs is the ability to provide immediate access and stabilization~     for those patients who have an emergency medical condition. However, emergency department~     (ED) crowding is recognized to be a major, international problem that affects patients and~     providers. A recent report from the IOM noted that the increasing strain caused by crowding~     is creating a deficit in quality of emergency care. Crowding has been associated with reduced~     access to emergency medical services, delays in care for cardiac patients, increased patient~     mortality, inadequate pain management, increased costs of patient care, and delays in~     administration of antibiotic therapy.~      Several issues remain concerning ED crowding and it's relation to adverse events. First, the~     existing evidence on adverse event occurrence during ED crowding is largely anecdotal and~     inconclusive. Secondly, although a few studies showed a relationship between ED crowding and~     mortality, neither of these examined the causes of excess mortality. Finally, although a~     significant increase in the average length of hospital stay was shown during ED crowding the~     reasons for this are open to speculation.~      The purpose of this study therefore is to identify six explicit adverse events and mortality~     for patients who were admitted through ED and to compare these results in relation to ED~     crowding. This will provide us novel insight into the reasons for the hypothesized increased~     mortality during ED crowding.~   "
187042|NCT01116310|"~     The purpose of this study is to evaluate the efficacy of FITOGYN vs. placebo on the vasomotor~     symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic~     parameters in menopause and to evaluate the quality of life associated to the vasomotor~     symptoms of menopause.~   "
187043|NCT01116297|"~     To perform a pilot study of the S-FLARE imaging system, which uses low levels of safe,~     invisible, near-infrared light to measure tissue oxygenation during breast reconstructive~     surgery and to compare S-FLARE measurements to the gold standard, FDA-approved, the ViOptix~     optical probe.~   "
187044|NCT01116284|"~     The purpose of this study is to determine if laparoscopic plication of a gastrojejunostomy is~     an effective surgical option for the Roux-en-Y gastric bypass patient who has regained weight~     due to a dilated gastric stoma. There are several reasons postulated to be the cause in~     patients who regain their weight after gastric bypass, including poor diet choices, dilation~     of the gastric pouch and enlargement of the gastric stoma. We aim to demonstrate that~     laparoscopic plication of the enlarge gastrojejunostomy can provide a safe and effective~     method to promote increased weight loss in this subset of gastric bypass patients.~   "
187045|NCT01116271|"~     The purpose of this study is to determine whether treatment with Selumetinib (AZD6244)~     (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or~     B-raf mutation will prevent tumor progression and prolong progression free survival.~   "
187046|NCT01116258|"~     The purpose of this study is to determine the safety, tolerability and blood levels of~     AZD5847 after daily oral dosing for 14 days.~   "
187047|NCT01116245|"~     Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the~     result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus~     that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus~     which causes cervical cancer. The purpose of the study is to test the safety, tolerability~     (how the drug makes you feel), immunology (effects on the immune system) and efficacy~     (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to~     cause the immune system to react against the E7 substance in a manner that is intended to~     reverse the changes to the cervix and prevent cervical cancer from occurring.~   "
188106|NCT01102387|"~     The aim of this study is to determine the efficacy and safety of once daily topical~     application of the combinational cream LAS41003 compared to the corresponding mono-substances~     in the treatment of candida infections in intertriginous areas at the trunk.~   "
187049|NCT01116219|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is~     not yet known whether bevacizumab given together with pemetrexed disodium and cisplatin is~     more effective than erlotinib hydrochloride given together with bevacizumab in treating~     patients with non-small cell lung cancer.~      PURPOSE: This phase II trial is studying giving bevacizumab together with pemetrexed disodium~     and cisplatin to see how well it works compared with giving erlotinib hydrochloride together~     with bevacizumab in treating patients with stage IV non-small cell lung cancer.~   "
187050|NCT01116206|"~     The purpose of this study is to compare the efficacy and safety of prucalopride to placebo~     (an inactive substance that is compared with a drug to test whether the drug has a real~     effect in a clinical trial) in treatment of participants with chronic (very serious, life~     threatening) constipation (decreased number of or difficulty making bowel [the intestine]~     movements).~   "
187051|NCT01116193|"~     The study objectives are to evaluate the safety and efficacy of the oral administration of~     lenalidomide in combination with dexamethasone in the treatment of adult patients with~     refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL).~   "
187052|NCT01116180|"~     Hypothesis: Treating patients with type 1 diabetes with a certain antihypertensive drug~     preserve cerebral function during hypoglycaemia.~      Background: Studies have found that certain genetic variations leaves a subject with type 1~     diabetes more prone to hypoglycaemia. It it thought to be a decline in cognition during~     hypoglycaemia that leaves them at risk of severe hypoglycaemia. The idea is tha when you~     suppress the genetic phenotype with a well known antihypertensive drug an improvement in~     cognition will occur and this will remove the patients tendency to severe hypoglycaemia.~      Methods: The investigators want to explore whether the cerebral function is improved during~     hypoglycaemia in subjects with type 1 diabetes and the above mentioned genetic variation when~     treated with the antihypertensive drug Candesartan.~   "
187053|NCT01116167|"~     Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the~     female population of reproductive age. Its heterogeneity is characterized by a wide spectrum~     of features, including ovulatory dysfunction and infertility, hyperandrogenism,~     hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming~     Dynasty in China,PCOS has been defined as phlegm and wetnessinfertility in traditional~     Chinese medicine ,namely metabolic infertility.Chinese herbs have been used to treat PCOS~     for thousands of years with good effects.Berberine has also been used for diabetic patients~     in traditional Chinese medicine for hundreds of years. Recent studies have reported its~     effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether~     Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.~   "
187054|NCT01116154|"~     RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune~     system in different ways and stop cancer cells from growing. Giving vorinostat together with~     lenalidomide may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when~     given together with lenalidomide in treating patients with relapsed or refractory Hodgkin~     lymphoma or non-Hodgkin lymphoma.~   "
187055|NCT01116141|"~     The purpose of this study is to determine if CH-4051 is a safe and effective treatment for~     rheumatoid arthritis.~   "
187056|NCT01116128|"~     Clinically demonstrated efficacy of Melphalan and Prednisone in MM subjects as well as the~     confirmed inhibitory effect of dasatinib on several tyrosine kinase receptors and pathways~     implicated in the pathophysiology of MM. Additionally, as a SRC inhibitor, dasatinib plays an~     important role on bone metabolism through inhibition of osteoclast-mediated bone resorption~     in vitro. Dasatinib could, thus, be beneficial on bone density of patients on study, through~     blockage of osteolysis and control of bone lesions.~   "
187057|NCT01116115|"~     The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant~     formula on intestinal parameters in term formula fed infants.~   "
187058|NCT01116102|"~     The purpose is to characterize the in-line pressure profiles associated with several infusion~     technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded~     by recombinant human hyaluronidase (hylenex). The safety and tolerability of~     hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.~   "
187059|NCT01116089|"~     The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob®~     when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC®~     PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa~   "
187060|NCT01116076|"~     Decisions about the use of antibiotics for acute respiratory infections are the most~     frequently reported reason for consulting a family physician. Although it varies according to~     the specific type of acute respiratory infections, the use of antibiotics is estimated to be~     63% to 67%, well above the expected prevalence of bacterial infections thus suggesting~     overuse of antibiotics. Consequently, there is an urgent need for helping family physicians~     and their patients to improve the clinical decision making process regarding the use of~     antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a~     multifaceted intervention program that includes training in shared decision making, reminders~     and feedback targeting physicians, and decision support tools targeting patients on the~     decision to use antibiotics for acute respiratory infections. Results from this study will~     lay the ground for a national strategy targeting the improvement of the clinical decision~     making process regarding antibiotic use for acute respiratory infections in primary care. In~     turn, this will increase quality of care and patient safety.~   "
187087|NCT01115699|"~     The study will systematically investigate the use of repetitive transcranial magnetic~     stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI)~     followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to~     identify gene variants that predict rTMS response.~   "
187061|NCT01116063|"~     Pulmonary hypertension is frequently present in COPD and it is generally limited to a mild~     increase in mean pulmonary artery pressure. However some COPD patients are characterized by~     higher levels of mPAP at rest, fulfilling the definition of moderate or severe PH~     disproportionate PH .~      In these patients the elevated pulmonary pressures adversely affect the prognosis.At the~     present time the evidence for the the use of specific pulmonary vasodilators in the~     management of these patients are scarce and cannot be recommended.the aim of this study is to~     evaluate the medium term efficacy and safety of the inhaled prostacyclin stable analog,~     iloprost in patients with COPD and moderate to severe pulmonary hypertension~   "
187062|NCT01116050|"~     Postpartum haemorrhage (PPH) remains the major cause of maternal mortality in France. The~     most efficient treatment of severe PPH is sulprostone which is associated with cardiac~     complications. The objective of this study was to assess the efficacy and the safety of~     intrarectal misoprostol for curative postpartum haemorrhage treatment.~      We conducted a multicenter double blind randomized placebo control trial between June 2004~     and December 2007, among consenting women with postpartum haemorrhage and failure to oxytocin~     treatment.~      Our main criteria of judgement was quantification of blood loss and the use of sulprostone~     between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in~     similar opaque introducer.~   "
187063|NCT01116037|"~     The purpose of this clinical study is to determine if there is an increased incidence and~     rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the~     Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve,~     or replacement of a failed prosthesis.~   "
187064|NCT01116024|"~     This is a prospective, non-randomized, multi-center study designed to evaluate safety and~     effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing~     isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic~     Valve is an equine pericardial stented bioprosthesis.~   "
187065|NCT01116011|"~     This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This~     MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered~     AZD7268 after multiple ascending doses.~   "
187066|NCT01115998|"~     Self-produced locomotion often is limited in children with cerebral palsy and other~     conditions that cause severe motor impairments. As a result, these children may be at risk~     for secondary impairments in spatial cognition, communication, social development, and other~     domains influenced by independent mobility. To compensate, power mobility has increasingly~     been advocated for young children with severe motor impairments. The study hypotheses were:~        1. Children with severe disabilities that prevent independent locomotion who learn to use~          power mobility devices when they are 14- to 30-months-of-age will have greater~          communication, social, and cognitive development over a 12-month period, and will~          demonstrate more competent coping skills than children with the same characteristics who~          do not use power mobility.~        2. Parents of children who use power mobility will view it as a positive influence on their~          children's lives, and will perceive their children's development to be more mature than~          the parents of children who do not use power mobility will perceive their children's~          development.~   "
187067|NCT01115985|"~     This study is to assess the effect of ASP1585 on pharmacokinetics of atorvastatin in 2x2~     crossover method.~   "
187068|NCT01115972|"~     This study is to assess the effect of ASP1585 on pharmacokinetics of valsartan in 2x2~     crossover method~   "
187069|NCT01115959|"~     This study examines early antiepileptic treatment with valproic acid for acute cerebral~     hemorrhage against a placebo group immediately post event to evaluate the outcome of these~     patients regarding seizures and neurological outcome.~   "
187070|NCT01115946|"~     This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2~     crossover method.~   "
187071|NCT01115933|"~     The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small~     Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment~     of subjects with ischemic heart disease caused by de novo lesions.~   "
187072|NCT01115920|"~     This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to~     evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous~     infusion doses of MTP-131.~   "
187073|NCT01115907|"~     The purpose of this clinical investigation is to demonstrate the safety and effectiveness of~     the Freedom SOLO heart valve.~   "
187074|NCT01115894|"~     Problem drinking gay and bisexual men who try to quit drinking are at risk for relapse to~     heavy or problematic drinking because their social lives and social outlets are often~     strongly associated with alcohol. These men are most receptive to interventions focused on~     moderation of drinking rather than abstinence. However moderation-oriented cognitive-behavior~     therapy (CBT) and naltrexone (NTX) are both well established treatments for problem drinkers~     who wish to moderate, rather than stop, drinking. Research suggests that combining these~     treatments may enhance their efficacy.~      This study combines moderation-oriented CBT with NTX in the treatment of problem drinking gay~     and bisexual men, who do not wish to abstain from alcohol, to evaluate their efficacy alone~     and in combination. We also propose to utilize new data collection technology, Interactive~     Voice Response, to collect data on daily relations among drinking, sexual behavior and~     psychological variables thought to mediate treatment response. Our objectives are to~     evaluation the efficacy of 12 weeks of randomly assigned treatment, with 100 mg of NTX or~     placebo, combined with brief supportive therapy or modified, behavioral self-control therapy~     specifically tailored to gay/bisexual men; to evaluate conditional relationships between~     heavy drinking and likelihood of HIV risk behavior; and to evaluate daily associations among~     mood, craving, self-efficacy, motivation, and drinking. Assessments will include baseline, 3,~     6, & 9 month follow-up. A substudy of the treatment trial will be conducted to collect and~     bank samples from blood for research aimed at associating naturally occurring differences in~     DNA with patient response to NTX, and with potential mediational mechanisms of action of NTX.~     Information gathered on genes or gene products may be used in conjunction with data on~     clinical psychological factors obtained as part of the clinical trial to evaluate~     relationships among genetic variants, drug effects, and mechanisms of treatment response.~     Patients will be asked to give a blood sample at Week 0 of the clinical trial for the purpose~     of carrying out genetic research.~   "
187075|NCT01115881|"~     Signal strength is a parameter introduced in analysis software version 4.0.1, of the OCT~     stratus, that combines SNR and uniformity of the signal within a scan The scale of signal~     strength ranges from 1 to 10, with 1 representing poor image quality and 10 representing~     excellent image quality It has been showed that signal strength has a better image quality~     discriminating ability than SNR The operation manual recommends a minimum signal strength of~     5 for macular thickness measurement There is no consensus on the level of signal strength~     above which should be considered to be good quality The inclusion Criteria for acceptable~     signal strength varies widely in the literature the purpose of our study is to examine the~     relationship between signal strength and macular thickness measured by stratus OCT~   "
187076|NCT01115868|"~     There is considerable variation in scarring, within and between people, and between different~     ethnic groups. Individuals with more pigmented skin are more prone to severe scarring than~     those traditionally termed white. Prevascar is being developed by Renovo for use as a~     potential treatment for reducing scarring.~      Renovo's histological analysis of wounds and scars in human non drug studies demonstrates an~     increase in wound and scar width in subjects of African Caribbean ancestry over a 12 month~     period.~      It is hypothesised that IL-10 may be a potentially beneficial therapy for the reduction of~     scarring in Non Caucasians of African-Caribbean ancestry.~      This Renovo clinical trial will be carried out primarily to establish the effects of four~     doses of Prevascar on 1cm incisional and excisional scars in subjects of African Continental~     Group ancestry, as compared to placebo, and to further investigate the safety and tolerance~     of intradermally injected Prevascar in wounds.~   "
187077|NCT01115855|"~     A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure~     patients with placebo.~   "
187078|NCT01115842|"~     Vitamin D is known to have immune-modulator effects including suppression of proinflammatory~     cytokine expression and regulation of immune cell activity. Vitamin D supplementation has~     been associated with a reduction in pro-inflammatory cytokines in patients with heart~     failure, and vitamin D deficiency has been associated with higher rates of myocardial~     infarcts. The levels of pro and anti-inflammatory cytokines also effect the outcome after~     acute coronary events.~      The proposed interventional study is targeted as a feasibility study targeted at assessing~     the role of vitamin D as an anti-inflammatory mediator.~      The study is planned as a randomized open label interventional trial. The study will be~     conducted of 50 adult patients (25 interventional group, 25 control), all from the internal~     ward in Meir medical center. Patients which are admitted after an acute coronary event will~     be randomized to the Vitamin D supplementation group or to the control group. the vitamin D~     group will receive 4000IU per day of vitamin D for five days. Cytokine levels will be~     measured at day 1 and at day 5. follow up will be continued for 6 months~      Primary end point:~      Levels of immune mediating cytokines (CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10) after a five~     day intervention in patients serum.~      Secondary endpoints:~      Any major cardiovascular event within follow-up period. Any death of any cause during~     follow-up period~      Expected results:~      the investigators expect vitamin D supplementation after a pro-inflammatory state such as an~     acute coronary event, combined with conventional therapy, to result in decreased levels of~     inflammatory serum bio-markers.~   "
187079|NCT01115803|"~     Study JGCB is a multicenter, nonrandomized, open-label, dose-escalation Phase 1b study of~     LY2584702 in combination with either erlotinib or everolimus.~   "
187080|NCT01115790|"~     The primary purpose of Parts A and B of this study is to evaluate the safety and toxicity of~     prexasertib (an inhibitor of checkpoint kinase 1[chk 1]) in participants with advanced or~     metastatic cancer (Part A), or squamous cell cancer of the head and neck or squamous cell~     cancer of any tumor type (Part B). Part C of the study will evaluate prexasertib in three~     different groups of participants; those with squamous cell cancer of the head and neck that~     has recurred or spread to other parts of the body, those with squamous non-small cell lung~     cancer that has recurred or spread, and those with squamous cell cancer of the anus that is~     not curable by existing therapy.~   "
187081|NCT01115777|"~     In recent years, remarkable advances in medical oncology, surgery, and radiology have allowed~     for increasing cure rates for childhood malignancies. This success has led to an emerging~     understanding of the kinds of effects that treatments can have on the pediatric population~     and how such effects can influence pediatric cancer survivor's functioning and quality of~     life. It has become tremendously important to assess the long-term complications due to~     therapy in this growing sector of survivors and to tailor our treatments so as to minimize~     these late effects.~      The Investigators at MGH are committed to improving the delivery of radiotherapy to our~     patients and improving the outcome for these patients. MGH has an on-site cyclotron for~     proton radiotherapy in order to provide the most advanced care for patients in need. Proton~     therapy possesses a clinical advantage over standard photon therapy in that its optimal dose~     distribution delivers the bulk of radiation to the tumor site. This method spares the~     greatest volume of normal tissue, resulting in decreased short-term and long-term morbidity.~      Through open pediatric protocols for patients treated with proton radiotherapy, the~     investigators aim to define and report the acute and late effects associated with treatment.~      The investigators also treat a number of patients off-protocol with both proton and photon~     radiotherapy, and are interested in reporting these patients' QOL outcomes in conjunction~     with other clinical data that may be pertinent to the site of tumor treatment. This research~     is significant in that it will allow us to delineate the positive and negative effects of~     radiation treatment on patients' QOL, highlighting points of success and exposing areas that~     are in need of improvement. Such knowledge will be used to improve the experience of~     pediatric cancer survivors in the future.~      The aims of this study are: 1) to prospectively collect and report the QOL outcomes in~     patients treated with radiotherapy and 2) to correlate the QOL data with pertinent clinical~     information.~   "
187082|NCT01115764|"~     Aims: To test the hypothesis that Diastolic dysfunction severity correlates with adverse~     clinical outcome in patients with systolic heart failure.~   "
187083|NCT01115751|"~     Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral~     LY2780301 in patients with advanced solid tumors.~   "
187084|NCT01115738|"~     This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during~     percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on~     platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet~     inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in~     a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg).~     Understanding the effects of this combination on platelet inhibition will provide guidance to~     physicians on the use of prasugrel in patients who have already been pretreated with~     clopidogrel.~   "
187085|NCT01115725|"~     This is a prospective, open-label, non-comparative, multicentric Phase 4 study to evaluate~     the ease of use, local tolerance, safety and effectiveness of Gonal-f® (filled-by-mass in a~     prefilled pen) in subjects undergoing ovarian hyperstimulation for in vitro fertilization~     (IVF) or intracytoplasmic sperm injection (ICSI) with recombinant follicle stimulating~     hormone (r-FSH).~      Clarification for change of study type:~      The study was erroneously registered as an interventional trial on ClinicalTrials.gov between~     2010 and 2012. It was shown recently that the study protocol and conduct of the study did not~     include any clinical interventions beyond those which are Standard Clinical Practice and the~     approved label for Gonal-f®. Furthermore, all other relevant study essential documentations~     (e.g. Informed Consent, CRF, etc.) are in line with an observational study design. As per EU~     regulations (Article 2(c) of Directive 2001/20/EC), this study is a 'non-interventional~     trial'.~   "
187152|NCT01114854|"~     This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate~     Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with~     epilepsy.~   "
187088|NCT01115686|"~     The initial hypothesis is that branched-chain aminoacids (BCAA) administration could be~     beneficial to patients suffering from sleep apnea syndrome (SAS), the aim of the present work~     is to verify this hypothesis.~      The literature data demonstrate that a BCAA complementation improves the physical~     performances, protects lean mass and increases VO2 max during training.~      We demonstrated earlier that this complementation can cure at less partly the hypoxemia of~     chronic obstructive pulmonary patients by a stimulation of respiratory centres.~   "
187089|NCT01115673|"~     The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg~     and acetaminophen 1000 mg in dental surgery.~   "
187090|NCT01115660|"~     The objectives of the trial of a medication-coach program for patients with stroke or~     transient ischemic attack are to pilot test the study design, the intervention components and~     the data collection forms and refine them for a larger trial whose goal will be to improve~     long-term adherence to stroke prevention medications.~   "
187091|NCT01115647|"~     Child malnutrition is intimately associated to poverty and may be due to sub-optimal feeding~     behaviours, food insecurity at household level, or a combination of both. Acute malnutrition~     is a major contributor to under-5 mortality and morbidity in developing countries. While~     clinical guidelines for severe acute malnutrition (SAM) have been available for a decade,~     research on the management of moderate acute malnutrition (MAM) has lagged behind.~     Nonetheless, MAM is much more incident than SAM, it increases mortality risk by itself and~     requires special nutritional treatment. This study is thus meant to address this major gap,~     by testing the relative feasibility, effectiveness and cost-effectiveness of three innovative~     strategies for treating children with MAM aged 6-24 months : a locally produced Ready-to-Use~     Therapeutic Food (RUTF), a corn/soy blended flour (CSB++)provided by the World Food Program,~     and a specific and context-appropriate child-centred counselling.~      The evaluation will be carried out as a cluster-randomized trial in the Houndé district,~     Burkina Faso, where 18 rural health centres will be randomly allocated to RUSF or CSB or CCC~     for treating MAM.~   "
187092|NCT01115634|"~     Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct~     sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good~     and radiant skin. However despite all the care taken passage of time will bring about~     conditions that will automatically lead to skin aging, which may require certain therapeutic,~     care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a~     critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is~     the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of~     skin fibroblast along with differentiation of stem cells in the skin tissue is the best~     method for healing.~   "
187093|NCT01115621|"~     The major goals of this project are to determine whether primary intervention through delayed~     introduction of dietary gluten is feasible and could reduce the incidence of islet~     autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.~   "
187094|NCT01115608|"~     It is well known that secondary prevention is very important for patients with established~     coronary heart disease, it reduces both mortality and morbidity. Pharmacists in Norway are~     not routinely involved in follow-up of this patient group, but many studies have shown that~     involvement of a pharmacist have a positive influence in achieving therapy goals for e.g.~     blood pressure, lipids and blood sugar.~      The investigators hypothesis is that follow-up by a clinical pharmacist after hospital~     discharge will increase adherence to clinical guideline recommendations and increase~     achievement of specific therapy goals for blood pressure, lipids and glucose in patients with~     established CHD. The investigators plan to include patients with established CHD, discharged~     from hospital after admission to the cardiology department.~      Patients included (18-80 years) will be randomized to an intervention and a control group. In~     addition to ordinary health care, the intervention group receives follow-up from a clinical~     pharmacist during one year with three meeting points, at discharge, after three months and~     after one year. The control group receives only ordinary health care, but are called in after~     one year for data collection. Patients living in nursing homes, patients already receiving~     pharmaceutical follow-up elsewhere and cancer patients are excluded from the study. Only~     patients living in the area of Tromsoe and nearby is included, as they need to physically see~     the pharmacist.~      The follow-up include medication review and subsequently solving of drug related problems in~     addition to drug information and monitoring of clinical therapy goals relevant for secondary~     prevention of CHD.~      The main outcome measures is adherence to specified review criteria defined in a medication~     assessment tool (MAT-CHDsp) based on recommendations from the European Society of Cardiology.~     Other outcome measures include 1)number of drug related problems identified and solved, 2)~     hospital admissions, 3)deaths.~   "
187095|NCT01115595|"~     The purpose of this study is to study the efficacy of allergen injection immunotherapy for~     allergic rhinitis by~        -  symptoms score~        -  medication score~        -  quality of life~        -  immunologic test from blood~   "
187096|NCT01115582|"~     This is a study in a small population of children who have inborn errors of bile acid~     synthesis who are currently taking established doses of the currently used cholic acid~     capsules prepared at the Cincinnati Children's Hospital Pharmacy. The study is designed to~     compare the efficacy of these currently used capsules with the efficacy of the same treatment~     provided in a cholic acid capsule that is made by a company that will be marketed after FDA~     approval.~      At baseline, patients receive established doses of cholic acid capsules prepared at the~     Cincinnati Children's Hospital Medical Center Pharmacy. During the study, patients receive~     the same treatment provided in the to-be-marketed (TBM) cholic acid capsule. Hence, patients~     serve as their own controls, with baseline values presenting the reference value (CCHMC~     cholic acid capsule) and values after 30 days treatment presenting the value for the~     investigational treatment (TBM cholic acid capsule).~   "
187097|NCT01115569|"~     This Phase 3, multi-center study will evaluate the long-term safety and tolerability of~     hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in~     subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will~     be evaluated.~   "
187098|NCT01115556|"~     This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to~     2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than~     30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to~     their treatment assignment.~      The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will~     be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.~   "
187099|NCT01115543|"~     This study was performed to determine whether calcitriol provides a therapeutic advantage to~     alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients.~   "
187153|NCT01114841|"~     This study will assess the potential of tazarotene foam to cause sensitization during a 48~     hour challenge following 21 days of exposure on the skin of healthy volunteers.~   "
188963|NCT01091116|"~     The purpose of this study is to determine whether intra-articular (knee joint) administration~     of MEN16132 is effective reducing the pain from knee osteoarthritis.~   "
187100|NCT01115530|"~     In this study we will evaluate whether the addition of a formal lower extremity resistance~     exercise training program and/or a nutritional supplement will improve the functional~     recovery of older adult veterans participating in a geriatric rehabilitation program for~     deconditioning. Specifically, subjects admitted to a geriatric inpatient rehabilitation~     program with a diagnosis of deconditioning will be randomly assigned to one of four groups;~     1) Control/standard rehabilitation program, 2) Standard rehabilitation plus resistance~     exercise twice per week, 3) Standard rehabilitation plus a daily nutritional supplement, 4)~     Standard rehabilitation plus the resistance exercise and the nutritional supplement. Subjects~     will participate in each program for 12 weeks. At the beginning and end of the study we will~     measure lower extremity strength, walking speed, and overall function (using the standardized~     Functional Independence Measure), and compare the changes in each group.~   "
187101|NCT01115517|"~     This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an~     adjunctive medication during pterygium surgery in preventing pterygium recurrence. A~     pterygium is a white fleshy growth on the surface of the eye, which can be removed~     surgically. However, after surgical removal, pterygia can recur. One way of minimizing~     recurrence is by applying a medication called mitomycin C to the surface of the eye during~     pterygium surgery. However, mitomycin is associated with certain side effects, such as~     thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of~     action and there is some evidence that it may be useful in preventing pterygium recurrence.~     In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and~     mitomycin C for preventing pterygium recurrence will be directly compared.~   "
187102|NCT01115504|"~     The study is performed to consider the effect of thiamine supplementation on symptoms and~     signs of patients with heart failure and systolic and diastolic function of left ventricle.~   "
187103|NCT01115491|"~     This is a Phase II, national, multicenter, open-label, non-comparative study to investigate~     the efficacy and safety of bevacizumab and temozolomide in patients with recurrent~     glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive~     bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent~     withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.~   "
187104|NCT01115478|"~     The purpose of this study is to determine the efficacy of zinc and/or vitamin A~     supplementation in reducing the risk of placental malaria and its associated adverse~     pregnancy outcomes.~   "
187105|NCT01115465|"~     The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in~     the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter~     deficiency (ISD).~   "
187106|NCT01115452|"~     An exploratory study investigating the direct application of potassium nitrate (KNO3)~     solutions of different concentrations in reducing dentine hypersensitivity.~   "
187107|NCT01115439|"~     In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium~     falciparum resistance to chloroquine (80%) and more recently an increasing degree of~     resistance to sulfadoxine-pyrimethamine monotherapy (12%). In 2003 the high failure rate of~     chloroquine against falciparum malaria led the national malaria treatment programme to switch~     its recommended first line drug treatment for uncomplicated Plasmodium falciparum malaria to~     artemisinin-based combination therapy (ACT) in the form of~     Artesunate/Sulfadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7~     days). The aim of this study is to conduct ongoing monitoring of the efficacy of the new~     combination against P. falciparum in a group of sentinel sites in Afghanistan.~   "
187108|NCT01115426|"~     This study evaluates prospectively the effects of an anti-angiotensin II regimen on renal~     outcome in patients with mesangioproliferative glomerulonephritis followed-up for 10 years.~   "
187109|NCT01115413|"~     The purpose of this study is to estimate the effect of maternal teenage on pregnancy and~     perinatal outcomes among Caucasian pregnant women.~   "
187110|NCT01115400|"~     The aim of this study is to evaluate the quality of life in patients with abdominal wall~     hernias using a user-friendly survey that is designed specifically for this population of~     patients. The investigators would like to use this survey to elucidate how quality of life of~     the patient is changed with the presence of an abdominal wall hernia.~   "
187111|NCT01115387|"~     The original study (GARM I) has been conducted for more than 18 years at the University of~     Pittsburgh Medical Center (UPMC). GARM II is a nationwide research study about age-related~     macular degeneration in the next generation of adults (49 to 65 years old). The purpose of~     this study is to identify the hereditary and exposure risk factors that lead to the~     development of ARM (Age related maculopathy).~      Participants will communicate with the research staff through a protected and confidential~     website and use this website to complete a number of questionnaires during the course of the~     study (see below). For genetic analyses, the participants will mail in easily self-collected~     saliva samples in special containers. Eye photographs and eye health records are sent to the~     research center from local sources through the Internet. Individuals are not expected to come~     to UCLA in order to participate.~      https://jseiclinres.jsei.ucla.edu/garm/~      Participants will be expected to answer questionnaires or surveys about medical history,~     ocular history and visual symptoms, family history, smoking, dietary supplements and light~     exposure.~   "
187112|NCT01115374|"~     Lymphedema is a frequent sequela of breast cancer treatment, that can develop up to 40% of~     patients. Lymphedema is the accumulation of protein-rich fluid (lymph) in the interstitial~     spaces of the affected body part due to a blockage or malfunction in the lymph system. It can~     appear in the arm, shoulder, breast, or thoracic area. Lymphedema swelling causes discomfort~     and sometimes disability. The treatment of lymphedema associated with breast cancer can~     include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and~     pharmacotherapy.~      In this study two treatments will be compared to reduce lymphedema: the manual lymphatic~     drainage (standard care) versus the low frequency sound waves.~   "
187113|NCT01115361|"~     The purpose of this study is to determine the effectiveness of an intervention, which is~     designed to increase contraceptive prevalence among postpartum women attending vaccination~     services who desire to either space or limit their pregnancies, thus reducing unmet~     contraceptive need in this population.~   "
195022|NCT01010737|"~     This is a phase I/II, randomized, single-blind, placebo-controlled escalating double-dose~     study of the safety and priming potential of an intramuscular Influenza vaccine~     (Multimeric-001) injected to elderly volunteers.~   "
187114|NCT01115348|"~     Stroke is the most common cause for motor disability in the grown-up population in the~     Western world. In Sweden > 80 % are above 65 years of age at onset (1).Areas in the brain,~     controlling the movement in the upper extremity (UE) are often damaged at a stroke, which~     leads to impaired function. This impairment of the UE often leads to limitations in~     activities of daily living and reductions in the level of social activities; therefore,~     interventions that will improve function are needed to reduce the consequences for the person~     living with stroke. The time course of recovery of the UE is not clear and therefore the~     optimal timing of the intervention for the person and its content (ways of intervention)~     uncertain.~      The investigators have developed objective assessments of motor performance with new~     technology (kinematic analysis and virtual reality with haptics). Since having an impaired UE~     often results in reduced capacity in daily living and social activities, this might lead to~     decreased participation. To complement the traditional focus on body function, there is a~     need for assessments of the person's activity level and participation, as well as~     self-perceived function.~      The results from this study will lay the ground for an intervention study focusing on~     improved function in the upper extremity.~   "
187115|NCT01115335|"~     In this study of neonatal male circumcision (NMC), the investigators will examine~     acceptability of among parents, feasibility of training providers and implementing services~     in various clinical settings, and the safety of service provision comparing three different~     surgical methods: the Gomco; the Plastibell; and the Mogen clamp. This operational study is~     being conducted to inform the scale up of neonatal male circumcision in Zambia.~   "
187116|NCT01115322|"~     The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a~     phototoxic reaction when exposed to UV and VIS light on skin of healthy volunteers.~   "
187117|NCT01115309|"~     This is a prospective, non-randomized, multi-center study to assess safety and long-term~     patency of the ostia treated with the XprESS device per the device indication for use (IFU).~   "
187118|NCT01115296|"~     Helicobacter pylori colonises an estimated 50% of the world´s population (Taylor & Blaser,~     1991; Go, 2002). Despite clear clinical guidelines on the treatment of this infection~     (Malfertheiner et al. 2007) there is a drive to find alternative ways to control this~     infection in a wider perspective without the complications of induction of antibiotic~     resistance in the pathogen.~      L. reuteri has been widely studied in clinical trials and has been shown to have probiotic,~     health-promoting effects in both adults and children (Connolly 2004; Casas & Dobrogosz,~     2000). L. reuteri has been shown in numerous studies to be safe for human consumption and it~     has been shown to colonise the human gastrointestinal tract (Wolf et al., 1995, Valeur et~     al., 2004).~      Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H.~     pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and~     this was concomitant with a reduction in symptoms associated with the infection (Imase et al.~     2007; Francavilla et al. 2007, unpublished data). Further, dietary supplementation with L.~     reuteri during and after the period of H. pylori eradication therapy has also been shown to~     reduce the side effects of this therapy without affecting the degree of eradication (Lionetti~     et al., 2007). It is also feasible, through the inhibitory action of L. reuteri on H. pylori,~     that pre-exposure to L. reuteri may weaken H. pylori and make it more susceptible to~     antibiotic attack during eradication.~      However, an earlier pilot study was not been able to demonstrate a reduction in gastric~     inflammation caused by H. pylori. This pilot study was performed with L. reuteri ATCC 55730~     that has since been found to lack anti-inflammatory activity in in vitro screens. Recent~     selection of natural, human L. reuteri strains has identified a specific strain with strong~     anti-inflammatory properties in vitro (Lin et al, 2007 and submitted 2007). A combination of~     this strain, together with the earlier proven L. reuteri strain, is expected to lead to both~     a reduction of H. pylori load as well as a reduction in the gastric inflammation related to~     the pathogen.~   "
187119|NCT01115283|"~     Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of~     vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This~     study uses psychophysical measures to study neural plasticity in both adults and children~     with amblyopia.~   "
187120|NCT01115270|"~     The main purpose of this study is to compare two types of treatment of hydrocephalus:~     placement of a ventriculoperitoneal (VP) shunt versus an endoscopic third ventriculostomy~     (ETV). A second goal of this study will be to understand how the two different types of~     procedures, VP shunt versus ETV, affect brain blood flow and pressures. Understanding these~     changes is important because the investigators hope is to someday be able to predict who will~     better respond to one procedure or another.~   "
187121|NCT01115257|"~     The purpose of this study is to examine and compare, prospectively, best corrected visual~     acuity (BCVA) outcomes and complications of a cohort of patients with Proliferative Diabetic~     Retinopathy and Tractional Retinal Detachment not involving macula undergoing pars plana~     vitrectomy (PPV) or conventional management (panretinal photocoagulation).~   "
187122|NCT01115244|"~     The primary objective of this study is to evaluate the efficacy of dapsone gel, 5% in the~     treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion~     of patients achieving success based on mean % reduction from baseline in total lesion counts~     at week six. Success for lesion reduction will be defined as statistically greater mean~     percent reductions at week six in the dapsone gel-treated extremity compared with the control~     extremity of each patient.~   "
187123|NCT01115231|"~     Risk factors for Age-related Macular Degeneration (AMD) involves genetic variations in the~     alternative pathway of complement inhibitor factor H. The complement system is part of the~     innate and adaptive immune system. Smoking is the only environmental factor known to increase~     the risk of Age-related Macular Degeneration (AMD). Using serum samples of Age-related~     Macular Degeneration (AMD) patients and controls the investigators will test the hypothesis~     that smoking increases Age-related Macular Degeneration (AMD) by increasing complement~     activation; and that this is positively correlated with known disease variations in the~     complement factor H (CFH) gene.~   "
187124|NCT01115218|"~     The aim of the study is to investigate whether it is possible to predict the success of~     trabeculectomy in patients with glaucoma through the examination of mediators of wound~     healing in anterior chamber fluid. The success rate of trabeculectomy with mitomycin C in the~     literature is about 75%. This leads on the question why 25% of the patients received~     trabeculectomy are not sufficient treated and have not a long-term IOP reduction. Precisely~     this question is to be examined by the study.~   "
187125|NCT01115205|"~     The purpose of the study is to evaluate the impact of an exercise programme organized into~     supervised walking groups on metabolic control, functional capacity and overall quantity of~     physical activity in subjects with type 2 diabetes.~   "
187126|NCT01115192|"~     The aim of the study is to compare the effectiveness in treatment of chronic blepharitis~     either with a phospholipid liposome suspension compared to a conventional therapy~     recommendation using diluted baby shampoo.~   "
187127|NCT01115179|"~     The inflammatory properties of propofol are still under debate. Apolipoprotein A-I (Apo A-I)~     is involved in the inflammatory process. This study was designed to determine whether and how~     propofol or its solvent modulate Apo A-I and the inflammatory response after surgical stress.~     The investigators study hypothesis was that propofol might modify the Apo A-I blood levels,~     and thus, modulate the postoperative inflammatory course.~   "
187128|NCT01115166|"~     In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is~     subjected to large changes. The purpose of this study is to see if it is possible with the~     help of volume kinetic techniques to use these variations to measure blood volume and fluid~     escape from the intravascular volume.~   "
187129|NCT01115153|"~     A prospective, randomized controlled clinical trial was conducted at the Hospital~     Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of~     antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous~     appendicitis.~   "
187130|NCT01115140|"~     A more recent prospective nonrandomized placebo-controlled double-blind clinical study~     demonstrated that metformin exerts a slight but significant deleterious effect on serum~     homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to~     increase the beneficial effect of metformin on the vascular endothelium.~   "
187131|NCT01115127|"~     The purpose of this study is to determine whether myo-inositol and melatonin, or myo-inositol~     alone, or melatonin alone, are effective in normalizing irregular bleeding and anovulatory~     cycles in pre-menopausal women.~   "
187132|NCT01115114|"~     The purpose of this study is to learn if patients being treated with second generation~     antipsychotics and with clinically meaningful elevations/levels in any metabolic syndrome~     elements will have better access to medical treatment more quickly if they are randomized to~     one of the following conditions: 1) a primary care provider located in the community mental~     health center where mental health treatment is provided (IMBED), 2) a medical care manager to~     help coordinate treatment with an outside primary care provider (Liaison) or 3) the standard~     practice of advising the patient to see a primary care doctor (Treatment as Usual).~   "
187133|NCT01115101|"~     The purpose of this study is to investigate adequate pain treatment for patients after~     cesarean. In this study oral opioids were compared to intravenous opioids as they are~     supposed to provide superior pain control.~   "
187134|NCT01115088|"~     The purpose of this study is to test the effects that three different types of sweeteners~     have on food intake, hunger and satiety levels, as well as insulin and glucose measures. The~     study of whether food or beverages containing Stevia influence food intake to a greater~     extent than food or beverages sweetened with Aspartame or Sucrose. Also, examining whether~     taste preference and taste sensitivity influence food intake.~   "
187135|NCT01115075|"~     The purpose of this study is to understand the mechanisms for oscillations of dietary~     fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over~     interval of 3 to 4 days.~   "
187136|NCT01115062|"~     The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and~     placebo on the level of pain, observed distress, difficulty of venipuncture and skin side~     effects in children undergoing intravenous blood draw in the emergency setting or the~     phlebotomy lab.~   "
187137|NCT01115049|"~     Objectives: The study aimed at assessing the efficacy of a new mouthwash in treating oral~     lesions due to removable prostheses.~      Methods: The present prospective randomized clinical trial was performed on 44 patients. The~     experimentation lasted for 4 weeks and 4 operators participated. The effects of the mouthwash~     were evaluated subjectively and objectively, with questionnaires, Visual Analogic Scales and~     clinical examinations. The results were statistically analyzed. The following variables were~     recorded: presence of mucosal lesions due to incongruous removable prostheses and lasting of~     pain after rinsing.~   "
187138|NCT01115036|"~     In the current study, the investigators will evaluate intratumoral pharmacodynamic and~     pharmacokinetic data associated with the administration of the HDACI, Panobinostat, among~     recurrent GBM patients. In addition, this study will evaluate the safety and tolerability of~     this agent, as well as evidence of anti-tumor activity in the patient population.~   "
187139|NCT01115023|"~     Iron deficiency is a common problem in the world and more so in the developing countries with~     a prevalence of 64 % (using WHO cut-off values of Hb <11.0 g/dl) among children, 9-36 months~     of age. The Pediatric population is especially vulnerable to iron deficiency anemia due to~     low intake of iron rich foods, rapid growth with high demand and losses of iron from body~     especially with the commonly found worm infestations in children. Mild to moderate iron~     deficiency is widely prevalent in children and can have several implications including~     failure to thrive, poor scholastic performance, repeated infections etc. Dietary measures~     along with therapeutic measures are recommended to combat Iron Deficiency Anemia (IDA).~     However, iron rich foods alone cannot be relied upon as a sole step to counter IDA. The~     utensil in which the food is cooked plays a major role in determining the final iron content~     of food. Several studies have documented that most of the foods (90%) contained significantly~     more iron when cooked in iron utensils depending on the acidity, moisture content, and~     cooking time of food.The daily dietary intake could vary from 11 to 6 mg of iron if iron~     utensil was used for cooking [3].~      Food cooked in Aluminum (Al) utensils has a higher Al content which can be detrimental to~     healthy individuals and particularly to patients with chronic renal failure.In healthy~     persons, diseases of central nervous system, as well as of hematopoeitic system, skeletal~     system and respiratory system are described due to excess of Aluminium consumption. Aluminium~     utensils have fast replaced iron cooking pots from Indian kitchens, hence a study to know the~     effectiveness of iron cooking pot as a measure to combat IDA is necessary.~      Studies have shown the utility of cooking food in iron utensil in prevention of IDA but the~     investigators did not come across a study to document the use of this modality in treatment~     of IDA in children. Since the investigators anticipate that the improvement of iron status~     will be a gradual process, so the investigators decided to evaluate the utility of cooking~     food in iron utensils on iron status in children with non-severe IDA (Hb% < cutoff point for~     age but > 5 gm %.~      To test the following hypothesis use of iron utensils for cooking food will result in~     improvement in iron status in Pediatric patients with nonsevere Iron Deficiency Anemia.~   "
187154|NCT01114828|"~     OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to~     cirrhosis patients with ascites despite having received treatment with conventional diuretics~     and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.~   "
187178|NCT01114516|"~     Though cervical insufficiency is a common cause of second trimester pregnancy loss, the~     placement of an emergent cerclage in these patients is thought to improve perinatal outcomes.~     It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated~     by need for emergent cerclage.~      The objective is to determine whether administration of peri-operative antibiotics and~     indomethacin to patients receiving emergent cerclages for cervical insufficiency increases~     latency period to delivery compared with patients receiving emergent cerclage alone.~   "
187140|NCT01115010|"~     The study aims to determine whether a proprietary, FDA approved stiffening wire improves the~     efficiency of colonoscopy (that is, decreases the duration of the procedure) and/or enables~     complete visualization of the colon in a greater proportion of cases (than when the procedure~     is performed without it) with old, used colonoscopes.~      Colonoscopes are designed with a delicate balance between stiffness and flexibility.~     Stiffness helps to prevent curling (looping) of the colonoscope in those sections of the~     colon that are not fixed to the wall of the abdominal cavity and flexibility enables~     successful negotiation of bends or flexures in the colon. As colonoscopes age, they lose~     stiffness and this makes it very challenging to advance the colonoscope all the way to the~     cecum (the upper end of the colon). Even when the cecum is successfully reached, it may take~     an inordinately long time.~      In Jamaica, most endoscopists (General Surgeons and Gastroenterologists) use older, pre-owned~     colonoscopes imported from the USA, because the average patient and local health insurance~     companies cannot bear the level of fees that would enable cost recovery for new equipment.~      The stiffening wires (in two grades of stiffness) used in this study are passed through the~     biopsy channel of the colonoscope only after its tip has passed the upper end of the~     descending colon and entered the transverse colon. The device is safe when used as~     recommended by the manufacturers (and approved by the FDA), and does not appear to increase~     risk over and above the risk of colonoscopy with the unassisted colonoscope. Although the~     device clearly improves the stiffness of the colonoscope, there is no research evidence that~     it actually works in practice, either to improve cecal intubation rate or to decrease~     procedure time. It is therefore also unclear whether the possible benefit of using the device~     is achieved if introduced at the first opportunity allowed by the manufacturers or only after~     difficulty is encountered with the unassisted colonoscope.~      In this study, patients are randomly assigned to one of 3 interventions. One group has~     colonoscopy performed with the colonoscope alone and the wires are only introduced if there~     is difficulty advancing the colonoscope after it has passed into the transverse colon~     (difficulty defined as failure to advance the tip of the colonoscope after 5 minutes). In~     the 2nd and 3rd groups, the assigned wire will be introduced as soon as the colonoscope~     enters the transverse colon and is removed if difficulty is encountered, as defined above.~     The different phases of colonoscopy will be timed with a stop watch and when a sufficient~     number of patients has been accrued, the investigator will be able to compare the time it~     takes to complete the procedure with and without the wires as well as the proportion of cases~     in which the cecum was reached with and without the assistance of the wires.~   "
187141|NCT01114997|"~     The purpose of this prospective, randomized, double-blinded, active-controlled study is:~      To assess the effectiveness of systemic administration of lidocaine and esmolol in~     combination (vs. either drug alone) will result in improved postoperative outcomes for~     patients undergoing abdominal surgery (e.g., less pain and postoperative constipation, nausea~     and vomiting, faster return of bowel function, resumption of normal activities of daily~     living), leading to a shorten length of hospital stay, maintaining hemodynamic stability~     during general anesthesia, when administered as intravenous adjuvants~   "
187142|NCT01114984|"~     The purpose of this study is to better understand and characterize the pain that some~     patients experience after undergoing various breast surgeries, including breast biopsy,~     lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic breast augmentation, and~     breast reduction.~   "
187143|NCT01114971|"~     This study proposes to investigate the effects of labetalol or esmolol on managing the vital~     signs (like blood pressure and heart rate) during surgery, on pain management, and on the~     later recovery after surgery.~      It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.~   "
187144|NCT01114958|"~     This phase I study proposes the use of systemic thiosulfate rescue to allow supradose~     intra-arterial cisplatin delivery to lung tumors. Eligible patients would be those with at~     least one lung lesion large enough of characterize angiographically. All patients will first~     undergo a CT arteriogram of the target tumor. Patients will then receive 2 treatments on 2~     consecutive weeks. The primary endpoint will be toxicity, with secondary endpoint of response~     as measured on week 4. This pilot study will also determine how technically feasible it is to~     locate the blood supply to these tumors and deliver cisplatin.~      If the first 6 patients do well, 6 additional patients will be accrued for a total of 12.~   "
187145|NCT01114945|"~     This prospective, randomized study will compare the effectiveness of 4 different airway~     intubating devices which are most commonly used.~      The four different devices are as follows: McGrath video laryngoscope, GlideScope video~     laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.~   "
187146|NCT01114932|"~     The purpose of this study is to evaluate the relationship between the time needed to raise~     the oxygen concentration in patient's blood to 90% and his/or her body mass index. The~     prevalence of obesity in our society continues to rise. No studies have shown the time~     required for preoxygenation (oxygen given) in relation to body mass index (body weight in~     kg/height in meter2).~   "
187147|NCT01114919|"~     The main aim of this study is to compare the impact of a minimal and a full Internet-based~     self-help intervention for problem drinkers in the general population.~   "
187148|NCT01114906|"~     This study has been conceived in the context of Health Outcomes Research where the outcomes~     of health interventions in routine clinical practice constitute the main objective of the~     research process. In the case of asthma in Spain, the investigators do not clearly know the~     use of resources generated by the patient with asthma, its impact on the effectiveness of the~     current approach of asthmatic patients and the overall efficiency of health interventions on~     asthmatic patients. This observational, retrospective and multicenter study aims to estimate~     the use of health care resources in managing patients with asthma and to determine the~     management of the disease in the usual clinical practice in Valencia Autonomous Region. The~     data will be obtained at primary care level from the Electronic Health Record SIA+GAIA data~     base and at hospital level from allergologists and pneumologists clinical records. The~     investigators plan to introduce 289 ambulatory patients followed-up in Primary or Specialized~     Care Services, older than 15 years of age, diagnosed of asthma at least one year before the~     beginning of the study. The inclusion period will be of 3 months and the retrospective data~     of 12 previous months of follow-up will be collected.~      The direct and indirect use of resources will be collected in order to estimate the~     management and use of health care resources in managing patients with asthma in the~     Autonomous region of Valencia as primary endpoint and also to estimate the mean cost of~     asthmatic patient healthcare; to determine the global effectiveness and the efficiency of the~     actual asthmatic patient healthcare and to model the health budget according to different~     objectives of effectiveness for the next five years.~   "
187149|NCT01114893|"~     The purpose of this study is to determine the safety and efficacy of three concentrations of~     travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.~   "
187150|NCT01114880|"~     Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese~     participants with ankylosing spondylitis (AS) who have had an inadequate response to or who~     are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)~   "
187151|NCT01114867|"~     Hypothesis: Measurement of fetal penis length by ultrasound may be inaccurate when measured~     from the scrotum to the penile tip. we will provide normal values of penile length measured~     from the penile tip to the abdominal wall and measuring the corpus cavernosum length.~   "
187155|NCT01114815|"~     The purpose of this study is to delineate early neurological features and their progression~     in patients with cerebral autosomal dominant arteriopathy with subcortical infarcts and~     leukoencephalopathy (CADASIL) in order to facilitate early diagnosis, prevent erroneous~     diagnosis and mistreatment and improve physician education about this relatively common yet~     under-recognized dementing disorder.~      Patients with CADASIL suffer from a variant from migraine that differs from wild type~     migraine in terms of its severity, progressive nature and underlying pathophysiology.~     Recurrent stereotypic acute confusional state associated with the headache episodes in~     patients with CADASIL is a distinctive phenomenon, which if recognized will lead to an~     earlier and accurate diagnosis of this condition.~      Specific Aims:~        -  Characterize the nature, frequency and severity of migraine in patients with CADASIL.~        -  Delineate the phenomenon of acute confusional migraine as a distinct subgroup of~          migraine and establish its prevalence in patients with CADASIL.~        -  Determine the latency between the onset of neurological symptoms including migraine, and~          diagnosis of CADASIL and the prevalence of misdiagnosis.~   "
187156|NCT01114802|"~     This study will develop and examine the effectiveness of an intervention that utilizes~     multiple telecommunications technologies to improve cancer survivors' access to mental health~     care and increase their ability to manage the high risk transition time from active cancer~     treatment to survivorship. The intervention, referred to as Project Onward, uses an~     interactive website, e-mail, telephone, and an online social network. The purpose of this~     study is to pilot a novel intervention that can reduce costs, examine methods to improve~     adherence to internet based treatment and overcome numerous barriers to treatment for mental~     health concerns.~   "
187157|NCT01114789|"~     The objective of this study is to determine whether obesity has a protective effect on muscle~     proteolysis in hemodialysis patients submitted to a short starvation. This effect will be~     tested by comparing measuring muscle proteolysis, using regional infusion of a tracer amino~     acid (D5 phenylalanine) in two groups of obese and non-obese patients compared to obese and~     non-obese control subjects.~   "
187158|NCT01114776|"~     The purpose of this study is to initiate pilot studies to demonstrate that a sufficient~     number of iron-overloaded thalassemia, SCD and DBA populations with similar duration of~     chronic transfusion, and age at start of transfusions would be available for a confirmatory~     study and to validate that proposed multicenter MRI and biochemical studies can be completed.~     The study will examine the hypothesis that a chronic inflammatory state in Sickle Cell~     Disease (SCD) leads to hepcidin- and cytokine-mediated iron withholding within the RES~     (reticuloendothelial system), lower plasma NTBI (non transferrin bound iron) levels, less~     distribution of iron to the heart in SCD.~   "
187159|NCT01114763|"~     Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a~     part of Hämeenlinna Metabolic Syndrome Research Program (HMS), 40 men with metabolic syndrome~     and their 40 physically active controls (age: 30 to 65 years) are compared in a~     cross-sectional study. Except routine laboratory parameters, arterial elasticity and levels~     of oxidized LDL are determined.~      Study hypothesis: Levels of oxidized LDL and findings in arterial elasticity may differ~     between subjects with metabolic syndrome and controls explaining the elevated risk for~     cardiovascular diseases among patients with metabolic syndrome.~   "
187160|NCT01114750|"~     A pharmacokinetic study on the absorption of perorally delivered insulin in dextran matrix~     after single dose administration.~   "
187161|NCT01114737|"~     This double-blind, placebo-controlled, randomized study is designed to evaluate the safety~     and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in~     subjects with PKU.~   "
187162|NCT01114724|"~     The purpose of this study is to determine if the Valiant stent graft is safe and effective in~     treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall~     of the aorta, that causes blood to flow between the layers of the aorta and force the layers~     apart (dissect). This condition is a medical emergency and can quickly lead to death. Since~     stent grafting has been an effective way to treat other aortic conditions such as aneurysms~     (bulge in aorta wall), it is believed that the device would be effective in treating~     dissections. Information will be collected on the performance of the device for 5 years.~   "
187163|NCT01114711|"~     We are looking for women who suffer from menstrual migraine to participate in a 2-visit~     migraine brain imaging research study. Our goal is to see how the menstrual migraine brain's~     pain pathways function when the migraineur has been taking Frovatriptan. During the screening~     visit (Visit 1) participants will sign the informed consent form, complete questionnaires,~     meet with the study physician, and have QST (quantitative sensory testing: to determine your~     pain thresholds for a heat stimulus) performed. For Visit 2's MRI scan, subjects will be~     asked to lie very still while the scan is occurring. In some parts, they will not have to do~     anything, while in others they will be asked to rate pain and unpleasantness for brush and~     thermal stimuli. Participants are compensated for both visits.~   "
187164|NCT01114698|"~     The purpose of this study is to evaluate the effectiveness and safety of JNJ26489112 compared~     with an active control (Venlafaxine XR) and placebo in patients with Treatment-Resistant~     Major Depressive Disorder.~   "
187165|NCT01114685|"~     A comparison of changes in bone density following the same bone-health plan, but with a~     different bone-health supplement.~   "
187166|NCT01114672|"~     Pruritis (itching) is common in many people with chronic renal failure on hemodialysis. There~     may be many different reasons for the pruritis. Efforts to treat the problem have not been~     very effective.~      Vitamin D levels have been found to be low in many hemodialysis patients. Since vitamin D~     plays an important role in the skin and is effective in treatment of certain skin conditions~     that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients.~      The objective of the investigators study is to determine the effect of supplementation with~     oral vitamin D2 (ergocalciferol) on pruritis in hemodialysis patients.~   "
187177|NCT01114529|"~     The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to~     everolimus conversion at 10-14 weeks post transplantation improves renal allograft function~     without compromising efficacy compared to standard CNI treatment in de novo renal allograft~     recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen~     on evolution of cardiovascular parameters in de novo renal allograft recipients~   "
187167|NCT01114659|"~     Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive~     age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic~     criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous~     as the syndrome. This first part of study is determine whether genetic polymorphisms~     influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and~     controls. Furthermore, women with PCOS were reported with high risk of cardiovascular~     disease, the investigators planned to calculate the difference of carotid intima-media~     thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal~     control to determine the premature atherosclerosis of women with PCOS.~   "
187168|NCT01114646|"~     Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced~     fractures of the femoral neck in the elderly and is associated with a better functional~     outcome and fewer reoperations than internal fixation. Currently, the operative management of~     displaced femoral neck fractures favors the use of cemented implants. This technique is~     believed to be more stable in the immediate post-operative period, but there is limited~     evidence of a decreased morbidity and mortality with cemented versus press-fit stems~     (uncemented). In 2006, a meta-analysis concluded that the evidence was too limited to~     recommend a cemented or press-fit hemiarthroplasty.~      In this investigation, the morbidity, mortality and functional outcome associated with~     cemented and press-fit hemiarthroplasty will be compared prospectively. We propose that the~     use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the~     femoral neck would be associated with a decreased risk of adverse peri-operative outcomes,~     and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent~     at one year.~   "
187169|NCT01114633|"~     Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive~     women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major~     diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation,~     amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to~     hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the~     long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are~     potentially dangerous in women health. Early diagnosis and prevention is very important to~     the PCOS patients.~      Obesity is the most potential risk of threat to health of populations. There is a major~     impact of obesity on the PCOS related disorders. Insulin resistance and distribution of~     adipose tissue were thought to be the important risk factors of cardiovascular and metabolic~     syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific~     medical team. The investigators recently published in Fertility and Sterility about the~     clinical presentation of androgen excess in Taiwanese women. Hirsutism is much less~     prevalence (30%) in Taiwanese PCOS women than that previous reported (65-80%) in theWestern~     women. It is important to know that some clinical presentation of PCOS might have ethic~     variance. Insulin resistance was reported as another candidate that might have ethic~     variance. The investigators had reported about 40% women in PCOS women were obese, it is~     similar with previous literature reported. Obesity is a major factor that could be controlled~     during the treatment of PCOS.Weight reduction is one of our methods in PCOS treatment. The~     progressive results for obese PCOS women would be facing the risks of diabetes and metabolic~     syndrome. The investigators thought like to evaluate the benefit of weight reduction program~     to the prognosis of obese women with PCOS.~      Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of~     cardiovascular disease, the investigators would like to know the role of EPC to predict~     metabolic syndrome in women with PCOS. Wan-Fang hospital has a professional team in PCOS~     treatment and research which including gynecological endocrinologist, cardiologist, medical~     endocrinologist, specialist in weight reduction. This team had been working well for more~     that 4 years.~      The investigators hope that we can make a contribution to the study and treatment of PCOS in~     Taiwan.~   "
187170|NCT01114620|"~     The purpose of this study is to comply with the post marketing condition to the exceptional~     approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK~     Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.~   "
187171|NCT01114607|"~     This is an open-label, single dose, randomized, five-period, crossover study in healthy~     volunteers to assess the relative bioavailability of four GSK developed oral formulations of~     GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb,~     PROTECT-1 Study and ChemoCentryx Thorough QT/QTc Study.~      Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the~     five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples~     will be collected following each dose and safety assessments will be performed. The relative~     bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx~     formulation while the relative bioavailability the three other formulations will be compared~     to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.~   "
187172|NCT01114594|"~     The aim of this pilot project is to assess the potential of urine micro-RNAs (miRNA) as~     biomarkers for characterizing patients with autosomal dominant polycystic kidney disease~     (ADPKD) compared with patients with other causes of chronic kidney disease.~   "
187173|NCT01114581|"~     The purpose of this research study is to explore the mechanism of action of Mucinex, an oral,~     over-the-counter, FDA approved expectorant in patients with acute respiratory tract~     infections.~   "
187174|NCT01114568|"~     The purpose of this study is to examine the rate and extent of absorption of three oral~     formulations of ertugliflozin (PF 04971729, MK-8835) administered in lean to obese healthy~     volunteers.~   "
187175|NCT01114555|"~     The purpose of this study is to find how good and how safe the combination of irinotecan,~     temozolomide and bevacizumab is for patients with resistant or recurrent neuroblastoma. These~     drugs have each been given separately to patients, but they have never been given all~     together. Irinotecan and temozolomide are two drugs that have been used together to treat~     neuroblastoma in many people. These drugs are considered chemotherapy. Bevacizumab is another~     drug used to treat cancer. It is made by a company called Genentech. Bevacizumab is an~     antibody. Antibodies are proteins that are found in the blood and can attach themselves to~     bacteria and viruses. Bevacizumab attaches itself to a special protein in the bloodstream.~     This protein helps tumors grow new blood vessels. Blood vessels carry nutrients to feed the~     tumor. Bevacizumab is thought to block this growth of new blood vessels and starve tumors. It~     has been used for the treatment of many cancers in adults. It is approved by the FDA for the~     treatment of adults with colon cancer and other cancers but not for people with~     neuroblastoma. There is only a small amount of information known on using this drug in~     children. It has been used with irinotecan before to treat cancer but not in children with~     neuroblastoma.~   "
187176|NCT01114542|"~     This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect~     on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1~     diabetes.~   "
187205|NCT01114165|"~     The overall objective of this study is to assess the clinical value of the SeptiFast Test as~     an adjunct to traditional microbiological, clinical, and other laboratory assessments in~     early detection and identification of a potential pathogen and therefore early targeted~     antimicrobial management of neutropenic hematological patients with suspected infection or~     sepsis.~   "
187179|NCT01114503|"~     The purpose of this study is to investigate the safety and tolerability of otelixizumab in~     patients with Graves' ophthalmopathy (thyroid eye disease). There is currently no alternative~     therapy available for this condition other than treatment with steroids, or radiotherapy and~     surgery. The study also includes a comparison of the current steroid treatment,~     methylprednisolone, with the proposed new otelixizumab treatment.~   "
187180|NCT01114490|"~     This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib.~   "
187181|NCT01114477|"~     The major objective of this observational study is to describe clinical outcomes of patients~     receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.~   "
187182|NCT01114464|"~     The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or~     neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A~     new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to~     evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations~     and after during follow-up (24 months). This strategy offers 2 main advantages : no~     modification of the traditional care of patients (treatment, organisation, follow up …) and~     use of a non invasive marker (serum). The final objective is to give precise information to~     patients on their future fertility after remission.~   "
187183|NCT01114451|"~     Whenever a person has a cesarean section there is a risk that there will be a problem with~     healing of the wound. The most common type of wound healing problem is separation and opening~     of the skin and fatty tissue just beneath the skin. This type of wound healing problem~     happens more often when the patient has a high body weight. In most cases, metal staples are~     used to bring the skin together to close the wound. Usually, the staples are left in place~     for a longer time when the woman is heavy, in hopes of decreasing the chance of wound healing~     problems. But it is not known if leaving the staples in for a longer time is actually~     helpful. In some cases, leaving the staples in longer may cause more pain and will require~     you to see the doctor again to get the staples taken out. The purpose of this study is to see~     if there is any difference in how the wound heals in heavy women after cesarean section when~     the skin staples are removed after a short period of time versus a long period of time.~   "
187184|NCT01114438|"~     The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post~     marketing environment in subjects who are obese and have Type 2 Diabetes.~   "
187185|NCT01114425|"~     The objective are to assess the nature and incidence of drug intolerance observed with a new~     antiretroviral triple therapy, Truvada® [0-0-1] + Isentress® 400 mg tablets [1-0-1],~     prescribed in a setting of the treatment of individuals with recent exposure to a risk of~     transmission of HIV infection and to compare the results with those of previous studies~     conducted according to the same methodology, with other combinations of antiretrovirals.~   "
187186|NCT01114412|"~     A major complication in studies to identify the nature of bladder sensations is language. It~     is difficult, if not near impossible, for the lay person, with no knowledge of physiology,~     anatomy or pathology, to put into simple terms a description of basic visceral sensations.~     Therefore, before the investigators can speculate about the detailed mechanisms generating~     sensation the investigators must overcome this language and communication difficulty. This~     will be addressed in the present study.~      There are important reasons why the investigators must identify the mechanisms generating the~     different sensations as the bladder fills. One of them is that these are basic physiological~     mechanisms which need to be better understood.~   "
187187|NCT01114399|"~     The aim of this study is to examine the effects of a diet rich in broccoli on cardiovascular~     disease risk using biochemical indicators such as blood lipid profiles, most notably~     cholesterol; markers of inflammation as well as established physiological measurements such~     as Pulse wave velocity (PWV), Augmentation index (AIx) and Ambulatory Blood Pressure~     Measurements (ABPM). Broccoli contains compounds known as glucosinolates which are~     metabolised to isothiocyanates when consumed. The major glucosinolate in broccoli is known as~     glucoraphanin which produces the isothiocyanate sulforaphane. The glucosinolates are thought~     to be the principal component in broccoli that may reduce CVD risk. The investigators will~     use a standard cultivar of broccoli and a cultivar that has enhanced levels of glucosinolates~     ('HG broccoli'). This broccoli has been used in previous intervention studies (e.g.~     ClinicalTrials.gov NCT00535977). Volunteers will be asked to consume 400g of standard~     broccoli, HG broccoli or peas each week over a 12 week period in a double blinded (for the~     broccoli) parallel study. The volunteers recruited will, according to the Joint British~     Societies (JBS 2) Guidelines on the prevention of cardiovascular disease (CVD) in clinical~     practise, have a 10-20% (mild to moderate) risk of developing cardiovascular disease or~     having a cardiovascular (CV) event in the next 10 years.~   "
187188|NCT01114386|"~     Cigarette smoking, the major risk factor for COPD, causes not only airway and lung~     inflammation, but also systemic effects. These systemic effects of smoking could~     substantially contribute to the development of chronic diseases, other than COPD,~     particularly chronic heart failure (CHF). The aim of this project is to assess the frequency~     and severity of CHF and COPD in outpatients with history of smoking referred to Hospital~     because of dyspnea and/or chronic cough.~   "
187189|NCT01114373|"~     The purpose of this study is to test the effect of oral melatonin supplementation (24 mg per~     night for 4 weeks) on nighttime blood pressure in African Americans with a history of~     elevated nighttime blood pressure.~   "
187190|NCT01114360|"~     This purpose of this study is to test the effect of oral melatonin supplementation (8 mg per~     night for 4 weeks) on nighttime blood pressure in African Americans with a history of~     elevated nighttime blood pressure.~   "
187191|NCT01114347|"~     Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of~     this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine~     gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters~     placed in patients following pelvic surgery. The investigators primary working hypothesis is~     that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus~     preventing nosocomial urinary infections following pelvic surgery.~   "
187192|NCT01114334|"~     The purpose of the study is to determine whether motivational interviewing with~     guideline-based medical management for depression will significantly improve time to~     depression recovery and increase the proportion of subjects in recovery compared to~     guideline-based medical management alone over 9 months.~   "
187193|NCT01114321|"~     Dysfunction of autonomic nervous system is an important non motor feature of Parkinson'~     disease (PD). Lewy body formation is widely distributed in hypothalamus and in sympathetic~     and parasympathetic systems. Animal studies suggest a link between hypothalamus sensing of~     substrates and glucose metabolism. Thus, hypothalamus lesions could lead to change in glucose~     metabolism. Recently, we showed that fasting blood glucose level was significantly higher in~     PD patients than in control group suggesting that glucose tolerance may be impaired in PD.~     Some studies provided evidence for higher diabetes prevalence in PD patients whereas others~     showed no difference or a reduced risk of diabetes prevalence in PD patients compared to~     healthy subjects.~      So, the risk that a PD patient develops a glucose intolerance or a diabetes is not clearly~     established and merit to be studied considering the damageable consequences for patient~     healthy.~      The aim of this prospective study was to determine the risk that a PD patient develop a~     glucose intolerance or a diabetes compared to a matched control group, using an oral glucose~     tolerance test (OGTT).~   "
187194|NCT01114308|"~     Probuphine (buprenorphine implant) is an implant placed just below the skin containing~     buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will~     confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses~     treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.~   "
187195|NCT01114295|"~     Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by~     upper endoscopy and colonoscopy, the presumed source of bleeding in these patients being the~     small intestine. These patients fall under the category of obscure gastrointestinal~     bleeding, and frequently require an extensive diagnostic work-up.~      Obscure gastrointestinal bleeding (OGIB) refers to bleeding undiagnosed by upper endoscopy~     and colonoscopy. In 40-70% of cases of OGIB, a bleeding lesion is localizable to the small~     bowel. In OGIB, capsule endoscopy (CE) has a diagnostic yield of 40-80%, and has demonstrated~     diagnostic superiority to push enteroscopy, barium studies, angiography, CT angiography, and~     routine abdominal CT scan. When CE is non-diagnostic, however, the subsequent diagnostic~     algorithm is not well-defined. There is currently no established role for cross-sectional~     imaging for this indication. CT enterography (CTE) combines the spatial and temporal~     resolution of CT with an orally administered neutral enteric contrast material that permits~     detailed visualization of the small bowel. Unlike other imaging modalities such as nuclear~     medicine techniques and catheter angiography, CT is less labor-intensive, more readily~     available, and provides precise anatomic localization. A novel OGIB-protocol available at~     Brigham and Women's Hospital for CTE utilizes a dual-phase, dual energy technique that~     obtains images at two time points to better identify active bleeding in the mesentery. We,~     the investigators, plan to prospectively study an algorithm that employs CTE and compare to~     capsule endoscopy to investigate the effectiveness of both modalities and to evaluate the~     potential role of CTE in OGIB.~      The goal of our study is to determine observationally the contribution of both CE and the new~     protocol for CTE to the evaluation and management of overt obscure GI bleeding and~     accordingly revise the clinical algorithm.~      We hypothesize that CTE will be as or more effective than CE at identifying culprit lesions~     in overt, obscure gastrointestinal bleeding.~   "
187196|NCT01114282|"~     The purpose of this trial is to find out the maximum tolerated dose (MTD) of bortezomib~     (VELCADE) in combination with pralatrexate in patients with previously treated multiple~     myeloma, AL amyloid and Waldenstroem's macroglobulinemia.~   "
187197|NCT01114269|"~     This is a prospective, multi-center cohort study of patients with a history of coronary~     artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild~     to moderate left ventricular dysfunction (LVEF 35-50%). The primary objective of this study~     is to determine whether biologic markers and ECGs can be utilized to advance SCD risk~     prediction in patients with CHD and LVEF>30-35%. The overarching goal of the study is to~     identify a series of markers that alone or in combination specifically predict risk of~     arrhythmic death as compared to other causes of mortality among this at risk population of~     coronary heart disease (CHD) patients with preserved left ventricular ejection fraction~     (LVEF> 30-35%). If biologic or ECG markers are identified that can specifically predict risk~     of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to~     identify those at risk. The public health impact of identifying markers could be quite~     substantial, leading to more efficient utilization of ICDs and advances in our understanding~     of mechanisms underlying SCD.~   "
187198|NCT01114256|"~     The purpose of this study is to better understand the biology of the body's immune response~     to monoclonal antibody therapy for cancer. Your health information will be used to identify~     your tissues. The tissue we obtain may be useful for research or education, resulting in new~     drugs, therapies or diagnostic procedures.~   "
187199|NCT01114243|"~     Juvenile idiopathic arthritis (JIA) is a serious autoimmune childhood disease that~     encompasses several types of chronic arthritis. It is the most common rheumatic disease in~     children and can cause significant short-term and long-term disability, including permanent~     joint damage. Management of JIA is based on a combination of pharmacologic interventions,~     physical and occupational therapy, and psychosocial support. Intra-articular steroid (IAS)~     injection, or injection of steroid medication into an arthritic joint, is a routine~     therapeutic procedure in clinical rheumatology. Most pediatric rheumatologists currently~     perform injections based on knowledge of anatomy and by feeling for anatomical landmarks, but~     results from adult studies on ultrasound (US)-guided technique have suggested a role for~     using US in treating and managing JIA. The overall goal of this project is to determine the~     feasibility of a multicenter study comparing US-guided IAS injection with the usual technique~     of using external anatomic features to improve arthritis symptoms in JIA. The key issues that~     this pilot project will determine will be: 1) the ability to use US to successfully image and~     detect abnormalities in the joints in children with JIA 2) image the injected medication in~     the joint space or its surroundings immediately after the injection 3) determine methods to~     measure the clinical response to injection 4) evaluate the feasibility of using saved US~     scans to localize injected medication in or around the joints and to determine abnormalities~     concerning for arthritis. These results will be used to establish the protocols necessary to~     design a multicenter study to determine the effect of US-guided IAS injection in the~     treatment of juvenile arthritis. Studies regarding the applicability and feasibility of~     musculoskeletal US in an outpatient pediatric rheumatology setting are important in order to~     establish the utility of this new technology in guiding diagnosis and therapy in JIA. Results~     from this study may have a significant impact on pediatric rheumatology and the way by which~     pediatric rheumatologists currently assess signs of arthritis and perform routine therapeutic~     procedures.~   "
187200|NCT01114230|"~     The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK)~     of AGS-16M8F administered in subjects with advanced renal cell carcinoma.~   "
187201|NCT01114217|"~     To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron~     deficiency anemia (IDA).~   "
187202|NCT01114204|"~     The purpose of the study is to evaluate the efficacy and safety of intravenous (IV)~     ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).~   "
187203|NCT01114191|"~     This is a phase 1, open-label study designed to determine the interaction of ketoconazole~     with ABT-869.~   "
187204|NCT01114178|"~     Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate~     walking capacity in patients with claudication~   "
187206|NCT01114152|"~     This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending~     dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male~     and female Japanese subjects~   "
187208|NCT01114126|"~     The primary objective of the study is to evaluate the safety and tolerability of Neu-P11,~     following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching~     placebo) given nightly over 2 periods of 5 days to male and female subjects with primary~     insomnia. In addition, the study is aimed to determine the pharmacokinetic profile of Neu-P11~     after 1 and 5 days of administration and to evaluate the hypnotic effects of Neu-P11 as well~     as the effects on mood and memory. The study hypothesis is that Neu-P11 is safe, tolerated~     and have significant sleep promoting effects.~   "
187209|NCT01114113|"~     The rapid diarrhea that patients experience who have diarrhea occurring after eating specific~     foods may be causing a physiologic gastric dumping syndrome. This means that rather than~     the food being kept in the stomach for normal digestion, it rapidly goes into the small~     intestine and diarrhea occurs. This study is designed to measure how fast the food empties~     from the stomach when a person with this problem consumes a regular diet, compared to a~     meal with a triggering substance. Each participant will swallow a radio frequency capsule~     that with the different meals that will show how fast the food is traveling through the~     intestines in the different situations.~   "
187210|NCT01114100|"~     The purpose of this study is to determine whether care as usual or intervention (consisting~     of sertraline versus placebo), are effective in the treatment of panic disorder and/or~     depression driven noncardiac chest pain.~   "
187211|NCT01114087|"~     Evaluate the possible deleterious effects of tyrosine kinase inhibitors on sperm~     concentration, after 6 months of therapy, which corresponds to 2 cycles of spermatogenesis~     and on the sperm nuclear integrity. The main comparison criterion will be the mean difference~     in sperm concentration before and after the 6 month treatment.~   "
187212|NCT01114074|"~     Rationale: Cardiovascular diseases are important causes of morbidity and mortality in the~     industrialized world. Clinical studies indicate an important role for the proteins of the~     contact activation system (coagulation factor XII (FXII), FXI, prekallikrein and high~     molecular weight kininogen (HMWK)) on the risk of cardiovascular disease. There is~     substantial evidence from mouse studies that FXII and FXI participate in the formation and~     stability of thrombi and in vitro studies showed that collagen is able to activate FXII and~     hereby stimulate thrombin formation and potentiate the formation of platelet-fibrin thrombi.~     The investigators want to determine the role of the proteins of the contact activation system~     in platelet mediated thrombus formation in human blood.~      Objective: The investigators will study the effects of the proteins of the contact activation~     system on platelet mediated thrombus formation, embolization and degradation on collagen in a~     perfusion flow model.~      Study design: Blood will be collected from human volunteers via a venipuncture in the~     forearm. Each volunteer will donate maximally four times 30 ml of blood over a period of two~     days. This blood is used in perfusion flow experiments: blood flows over a coverslip covered~     with collagen in a flow chamber. The investigators will vary several conditions such as the~     concentration of the proteins and the shear rate. For perfusion flow experiments, the~     investigators need fresh whole blood because platelets are viable for four hours. After this~     time, new blood is needed.~      Study population: For this study the investigators need blood from human volunteers with a~     coagulation defect in one of the proteins of the contact activation system, e.g. FXII, FXI,~     prekallikrein or HMWK and controls without any coagulation defects.~      Main study parameters/endpoints: The investigators main study endpoint is the ex vivo~     formation of platelet-mediated thrombi on collagen in a perfusion flow model. The~     investigators hypothesize that thrombi formed from blood of patients deficient in FXII or FXI~     are less stable than those formed from blood from controls.~   "
187213|NCT01114061|"~     The aim of this study is to test the performance of the InsuPatch device in daily life. The~     primary target of the study is to evaluate safety aspect of daily device use. Additional~     aspects to be evaluated in the study are: the effect of the device on post prandial glucose~     level.~   "
187214|NCT01114048|"~     In this study, the investigators will analyze the long-term outcomes of remission and~     survival, and identify those with primary resistant disease as more likely to benefit from~     CTD (thalidomide, cyclophosphamide, dexamethasone) and early intensification of Vel-CD~     (bortezomib and CD) as induction chemotherapy followed by autologous stem cell~     transplantation for the patients with newly diagnosed multiple myeloma.~   "
187215|NCT01114035|"~     This PHRC is centred on the intestinal epithelial dysplasia ( DEI) or  tufting enteropathy ~     or TE the clinical and histo-pathological descriptions of which are specified well to the~     digestive plan(shot).~   "
187216|NCT01114022|"~     A number of techniques have been recommended for the prevention of ventilator acquired~     pneumonia (VAP). These techniques - such as patient positioning, continuous sub-glottic~     suction of the secretions, selective decontamination of the digestive tract etc… - aim at~     prevent the inhalation of oro-pharyngeal contaminated secretions around the cuff of the~     tracheal tube used for connecting the patient to the machine. Their efficacy has been~     regularly challenged and they are still unable to suppress totally the occurrence of VAP. The~     cuff of the tracheal tube used for long-term MV in the ICU is most often a low pressure high~     volume polyvinyl chloride (PVC) cuff in order to adhere to a large surface of the tracheal~     wall without inducing ischemic lesions. Recent advances allowed industrial companies to~     provide us with 1) polyurethane cuffs and 2) cuffs with a conic shape, both potentially~     offering a better tightness against inhalation at least in VITRO and in animal models. The~     effect on the reduction of VAP incidence has been suggested by several pilot series. The aim~     of the present project is to assess the efficacy of four types of cuffs (PVC with a conic or~     a cylinder shape and polyurethane with a conic or a cylinder shape) to prevent tracheal~     colonisation. We shall measure both oro-pharyngeal and tracheal colonisation during the hours~     and days following intubation. This will be done in 600 ICU patients of four university~     affiliated centres from France and Tunisia divided in 64 cluster randomized groups. The~     results of this research will confirm (or not) the rationale to perform a larger study~     designed specifically to address the impact on VAP.~   "
187217|NCT01114009|"~     The purpose of this study is to evaluate the effect of lung recruitment maneuver in patients~     with early ALI/ARDS~   "
187218|NCT01113996|"~     The purpose of the study is to test whether additional protein intake with or without~     strength training will help to maintain body composition (fat-free mass) after surgical~     treatment of obesity by gastric by pass. The main hypothesis is that additional protein~     intake will limit fat-free mass loss during surgery-induced weight loss, and that strength~     training will have an additional beneficial effect~   "
187219|NCT01113983|"~     A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the~     Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery~     system, Ascendra2™ transapical delivery system and crimper accessories. The trial includes a~     premarket pivotal cohort to evaluate the system performance as well as a post market clinical~     follow-up phase involving long term follow-up of all patients to evaluate the safety of~     investigational devices up to 5 years.~   "
187318|NCT01112696|"~     The purpose of the study is to assess the performance of a new subcutaneous glucose sensor~     over a seven-day sensor life when used with currently marketed Medtronic Diabetes devices. In~     addition performance will be calculated for use of the new sensor with proposed new devices~     using new calibration algorithms.~   "
187220|NCT01113970|"~     This study is a Phase I/II trial of a novel Indibulin dosing schedule for the treatment of~     metastatic breast cancer. Eligible patients will have measurable or non-measurable,~     metastatic or unresectable, locally advanced breast cancer and may have received any number~     of prior therapies for their disease.~      It is expected that the Phase I portion will enroll up to 20 patients and the Phase II~     portion will enroll up to 45 patients.~   "
187221|NCT01113957|"~     The purpose of this study is to determine the objective response rate of ABT-888 when given~     in combination with temozolomide versus pegylated liposomal doxorubicin (PLD) alone in~     subjects with recurrent high grade serous ovarian cancer.~   "
187222|NCT01113944|"~     We are testing whether various cognitive training procedures can enhance cognition and brain~     function~   "
187223|NCT01113931|"~     Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day~     for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7~     days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary~     efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events,~     changes in vital signs and laboratory test results.~   "
187224|NCT01113918|"~     Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive~     women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major~     diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation,~     amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to~     hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the~     long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are~     potentially dangerous in women health. Early diagnosis and prevention is very important to~     the PCOS patients.~      Obesity is the most potential risk of threat to health of populations. There is a major~     impact of obesity on the PCOS related disorders. Insulin resistance and distribution of~     adipose tissue were thought to be the important risk factors of cardiovascular and metabolic~     syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific~     medical team. We recently published in Fertility and Sterility about the clinical~     presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence (30%)~     in Taiwanese PCOS women than that previous reported (65-80%) in theWestern women. It is~     important to know that some clinical presentation of PCOS might have ethic variance. Insulin~     resistance was reported as another candidate that might have ethic variance.We had reported~     about 40% women in PCOS women were obese, it is similar with previous literature reported.~     Obesity is a major factor that could be controlled during the treatment of PCOS.Weight~     reduction is one of our methods in PCOS treatment. The progressive results for obese PCOS~     women would be facing the risks of diabetes and metabolic syndrome.We thought like to~     evaluate the benefit of weight reduction program to the prognosis of obese women with PCOS.~      Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of~     cardiovascular disease, we would like to know the role of EPC to predict metabolic syndrome~     in women with PCOS. Wan-Fang hospital has a professional team in PCOS treatment and research~     which including gynecological endocrinologist, cardiologist, medical endocrinologist,~     specialist in weight reduction. This team had been working well for more that 4 years.~      We hope we can make a contribution to the study and treatment of PCOS in Taiwan.~   "
187225|NCT01113905|"~     The investigators aim to test whether beta-endorphin, a substance our bodies make in response~     to painful and stressful stimuli, plays a causative role in radiation-induced fatigue that~     cancer patients receiving radiation therapy commonly experience. If this is so, the~     investigators' hope is to direct efforts at treating radiation-induced fatigue using agents~     that block the action of beta-endorphin with the aim of improving quality of life for~     patients undergoing radiation therapy~   "
187226|NCT01113892|"~     To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline. The~     investigators expect the performance of the grafts to be similar.~   "
187227|NCT01113879|"~     The purpose of the study is to reveal if individuals who participate in aerobic activity~     demonstrate improvement in language abilities than patients who do not participate in aerobic~     activity.~   "
187228|NCT01113866|"~     Biomarkers representing distinct biological domains including neurohormonal, inflammatory,~     metabolic-nutritional, oxidative-nitrosative and myocardial injury, might alone or in~     combination provide prognostic information on mortality in heart failure patients with~     preserved or impaired systolic function.~   "
187229|NCT01113853|"~     Previous studies have demonstrated that exhaled nitric oxide can be useful to monitor the~     efficacy of anti-inflammatory treatment as well as to predict a risk of asthma relapse in~     asthmatic patients.~      The aim of the present study is to evaluate the time course of exhaled nitric oxide in mild~     asthmatic patients, stopping regular treatment with inhaled corticosteroids, if it is~     possible, in relationship with symptoms and lung function.~   "
187230|NCT01113840|"~     The purpose of this study is :~        -  To determine if aerobic exercise conditioning can improve symptoms, cardiovascular~          function and quality of life in elderly patients with congestive heart failure.~        -  To describe the baseline clinical characteristics, cardiovascular function and~          neurohumoral function in elderly patients with congestive heart failure.~        -  To determine the specific cardiovascular and noncardiovascular mechanisms by which~          symptoms and quality of life may improve following exercise conditioning in elderly~          patients with congestive heart failure.~   "
187231|NCT01113827|"~     Six weeks of supplementation of an olive extract will:~        -  Improve antioxidant status~        -  Reduce inflammation~        -  Reduce muscle damage~        -  Improve exercise performance~        -  Improve exercise recovery as compared to a placebo.~   "
187232|NCT01113814|"~     This study will evaluate the effectiveness of Acoustic Radiation Force Impulse (ARFI)-~     Imaging compared to Transient Elastography (FibroScan) in differentiating liver fibrosis in~     patients with chronic hepatitis C. Patients who are scheduled to have a liver biopsy will~     also undergo ARFI and FibroScan testing. The liver biopsy will be used as the reference~     method. The target sample size is 433.~   "
187233|NCT01113801|"~     The purpose of this study is to determine if LY2382770 is safe and effective at protecting~     kidney function in participants with kidney disease due to diabetes.~   "
187234|NCT01113788|"~     The investigators propose a third hypothesis based on the anatomic observations made in~     pathological studies. The investigators hypothesize that the anatomic architecture determines~     the functional properties of the TV-IVC isthmus. As a result,~      • Muscular bundles are preferential routes of conduction through the TV-IVC isthmus. The~     isthmus acts like a series of discreet conduction routes rather than as a sheet of tissue.~      The muscular bundles form selective targets for ablation and therefore the entire anatomic~     line need not be ablated. This has direct implications for ablation of the isthmus.~   "
187288|NCT01113086|"~     The purpose of this research is to determine whether repetitive sessions of transcranial~     direct current stimulation (tDCS) to the prefrontal cortex can enhance the cognitive,~     affective and motor functioning of those with Parkinson's Disease.~      In this study we will compare active tDCS with sham tDCS. Each subject will receive two~     consecutive weeks of stimulation (Monday through Friday). A battery of neuropsychological and~     affective tests will be administered throughout the duration of the study.~   "
187235|NCT01113775|"~     This is a prospective, observational, multicenter study. The primary aim of the study is to~     assess the accuracy of spiral CT scan to detect right ventricular dysfunction as compared to~     current 'gold standard'in patients with pulmonary embolism. At the purpose of this study~     right ventricular dysfunction as assessed by transthoracic echocardiography and serum levels~     of troponin are considered as gold standard.~      The secondary aim of the study is to assess the prognostic value of right ventricular~     dysfunction as assessed by spiral CT scan.~   "
187236|NCT01113762|"~     Younger hip patients often need revision of their hip replacement due to wear and loosening.~     Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces~     in metal may reduce the wear, increase the longevity of the implant and give an improved~     function. The possible downside is that these concepts releases metal debris to the body. The~     investigators wish to see if the newer interventions are a clinical improvement compared to~     standard. The investigators also wish to investigate the extent of metal released to the body~     and any effect on the immune system. Finally the investigators wish to investigate the~     stability of these new implants and their ability to preserve the bone around the implant.~      The investigators hypothesis is:~      That the metal on metal articulations will not have better clinical outcomes than standard~     The resurfacing implant is expected to preserve the bone of the upper femoral bone. The~     implants are expected to be stabile within the first year.~   "
187237|NCT01113749|"~     This study is a randomized trial to test whether a decision aid can help to improve the~     quality of decision making about feeding options in care of patients with dementia.~   "
187238|NCT01113736|"~     The objective of this study is to investigate whether the use of Human Peritoneal Membrane~     (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for~     purposes of this study, as a decrease in adhesions resulting in decreased operative time~     during ileostomy closure, with promotion of peritoneal remodeling.~   "
187239|NCT01113723|"~     The purpose of this study is to evaluate whether tracheal intubation with the CMAC device~     decreases the time required for intubation as compared to intubation with the fiberoptic~     bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the~     fiberoptic bronchoscope are currently commonly used in standard of care practices in the~     intubation of patients with cervical spine injury.~   "
187240|NCT01113710|"~     This non-interventional observational study is designed to gain data for Neupro® in restless~     legs syndrome (RLS) under real life conditions in line with the summary of product~     characteristics (SmPC) related to effectiveness, tolerability and switching practice from~     other dopaminergic drugs as well as titration schemes.~   "
187241|NCT01113697|"~     The investigators are investigating the early and late responses to allergen challenge. The~     research participants who the investigators will study (from three cohorts) will be part of~     independently-approved studies involving allergen challenge. Due to the uniqueness of the~     cohorts for novel genetic study, it is logical that the investigators should initially~     undertake hypothesis-generating experiments. The investigators will obtain blood samples from~     the participants, both pre-challenge and post-challenge. The investigators will determine~     gene expression and protein differences between these samples, and investigate if there are~     inherited genetic differences between individuals that may predict their specific responses~     to allergens.~   "
187242|NCT01113684|"~     Deep brain stimulation (DBS) improves debilitating symptoms of movement disorders when~     conventional medical therapies and novel surgical therapies fail. Despite the remarkable~     efficacy of DBS, its therapeutic mechanism remains unclear. There is controversy regarding~     whether the therapeutic effects of DBS are associated with inhibition or excitation of target~     neurons, the introduction of new activity into the network, or a combination of these~     mechanisms. Additionally, it is unclear why stimulus frequency plays an important role in the~     clinical response to therapy. The fundamental hypothesis of this proposal is that unilateral~     subthalamic nucleus (STN) DBS in PD alters neuronal activity in the bilateral basal~     ganglia-thalamic-cortical motor system in a manner that is dependent on stimulation~     frequency.~   "
187243|NCT01113671|"~     This is a biomarker exploratory study which is designed to investigate the function and~     oxidation of the high density lipoprotein (HDL) (the good cholesterol) in patients with type~     2 diabetes mellitus treated with Vitamin E versus placebo and segregated by the type of the~     Haptoglobin protein they have in their blood.~   "
187244|NCT01113658|"~     The purpose of this study is to assess the efficacy of design improvements of the Spiracur~     SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current~     and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in~     order to optimize safety, efficacy, and system performance.~   "
187245|NCT01113645|"~     The purpose of this study is to examine the impact of cranioplasty on cerebral hemodynamic~     and blood flow as prognostic factor in patients receiving decompressive craniectomy for Head~     injuries, Subarachnoid haemorrhage, intra-cerebral haemorrhage, cerebral dural sinus~     thrombosis, malignant middle cerebral artery stroke.~   "
187246|NCT01113632|"~     The risk of immunosuppression deters many patients from receiving fludarabine, while~     combination chemotherapy regimens are poorly tolerated by elderly or infirm chronic~     lymphocytic leukemia (CLL) patients. Previous studies by our group and others have shown that~     rituximab is safe and well tolerated when used as a single agent in patients with CLL. In~     addition, maintenance therapy with rituximab was well tolerated by CLL patients, with~     probable prolongation of progression-free survival (Hainsworth et al. 2003). Based on pre~     clinical and clinical studies indicating possible increased efficacy of ofatumumab in~     patients with CLL, we wish to develop an antibody-only regimen for older patients and~     patients who refuse fludarabine-based regimens.~   "
187247|NCT01113619|"~     This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion~     and tolerance.~   "
187248|NCT01113606|"~     The aims of the Skin Product Assessment Research study were to (1) develop an infrastructure~     and process for industry-sponsored, Plastic Surgery Educational Foundation (PSEF) research in~     facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi~     Nu-Derm System (ODNS) and conventional therapy as treatment adjuncts in ablative facial~     resurfacing.~   "
187249|NCT01113593|"~     The purpose of this study is to characterize the pharmacodynamic profile of Formoterol~     Fumarate and Foradil Aerolizer~   "
187251|NCT01113567|"~     Two groups of patients with minimal hepatic encephalopathy will be studied. The treatment~     group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive~     lactose-free milk (3.5 g of lactose) two times a day for 21 days. Clinical history,~     nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency~     and a quality of life questionnaire will be performed. The patient will be assessed weekly 21~     days. An external monitor will control the randomization process in order to allocate the~     patients into both study group and will not share the assignation codes with anyone until the~     end of the study.~   "
187252|NCT01113554|"~     RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the~     quality of life of breast cancer survivors.~      PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving~     quality of life in breast cancer survivors.~   "
187253|NCT01113541|"~     The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of~     metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with~     glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their~     current antipsychotic medication.~   "
187254|NCT01113528|"~     To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as~     an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis~     patients.~   "
187255|NCT01113515|"~     The purpose of this study is to determine safety and efficacy of a new gel formulation of~     Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study~     will compare number and types of adverse events occured, rates of wound closure and~     percentage of wounds closed in Galnobax treated groups versus placebo group.~   "
187256|NCT01113502|"~     This is a phase I/II open label study being conducted to evaluate the overall safety and~     initial effectiveness of an investigational drug, Eltrombopag in patients who are 60 years of~     age and older and who have Acute Myelogenous Leukemia (AML). Eltrombopag is an~     investigational drug, which means it has not been approved by the U.S. Food and Drug~     Administration (FDA) for use in this type of disease. Approximately 35 people will be~     enrolled on this study at the University of Pennsylvania~   "
187257|NCT01113489|"~     Although it is well known that the presence of uncontrolled inflammation in upper airways may~     compromise the control of asthma and may favor the progression of asthma toward more severe~     grades of disease, few studies addressed whether therapies aimed to control both upper and~     lower airway inflammation may be more effective in controlling asthma. Markers of oxidative~     stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of~     children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with~     the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a~     facial mask (for treating both upper and lower airways) will be able to reduce the production~     of oxidants as well as of IL5 in both districts thus promoting clinical and functional~     improvements in mild intermittent asthmatic children. The results provided by this study will~     contribute to further clarify the relationship between nasal and bronchial inflammation.~   "
187258|NCT01113476|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Abraxane (nab-paclitaxel), Gemzar (gemcitabine), and Avastin (bevacizumab)~     that can be given to patients with advanced cancer. The safety of this drug combination will~     also be studied.~   "
187259|NCT01113463|"~     The goal of this clinical research study is to learn if TPI 287 can help to control~     glioblastoma. The safety of this drug will also be studied.~   "
187260|NCT01113450|"~     The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS).~   "
187261|NCT01113437|"~     Hypothesis- Omalizumab(humanized monoclonal anti-IgE antibody)improves disease control and~     reduces bronchial mucosal inflammation in non-atopic asthma.~      In order to test the above hypothesis, the investigators propose a placebo controlled, double~     blind, parallel group study to obtain proof of principle that omalizumab exerts beneficial~     effects on disease control in non-atopic severe adult asthmatics aged 18-60 years . Forty~     patients will be randomized in a 1:1 ratio to receive omalizumab or matching placebo.~     Following 12 weeks of treatment with omalizumab/placebo, and as this treatment is continued~     for a further 8 weeks, anti-asthma treatment will be reduced. Dosages will be administered at~     4 or 2 weekly intervals over a 16 week period (5 or 10 doses in total), which corresponds~     with the time stated as necessary to judge efficacy of therapy according to omalizumab's~     licensed indications in atopic asthma. Efficacy will be judged by clinical monitoring and by~     bronchial biopsy to assess effects on bronchial inflammation and local IgE production.~   "
187262|NCT01113424|"~     Bioequivalence between oral nicotine replacement products and Nicorette® gum.~   "
187263|NCT01113411|"~     The fracture of the proximal humerus represents 4% of the fractures encountered in clinics~     and it must be treated surgically. Thus, the aim of the surgical treatment is to maintain~     bone alignment, articular congruity, vascularization of the humeral head and provide a~     painless shoulder with satisfactory function.~      The objective of this study is to demonstrate the potential benefits of an early~     rehabilitation program on shoulder function.~   "
187264|NCT01113398|"~     The primary purpose of the study is to assess the response rate of AMG 102 and Avastin~     treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate~     overall survival and 6-month progression-free survival rates in this population and to assess~     the safety of this combination in this population.~      Patients must have recurrent histologically confirmed diagnosis of World Health Organization~     (WHO) grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3~     prior progressions. Subjects will receive Avastin and AMG 102 every two weeks. Avastin will~     be administered prior to AMG 102. Up to 36 adult subjects will take part in this study at~     Duke.~      In initial Phase I and II clinical trials, four potential Avastin-associated safety issues~     were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The most~     common side effect for AMG 102 have been nausea and fatigue.~   "
187304|NCT01112878|"~     The purpose of this research is to investigate the non-opioid (non-narcotic) pain-relieving~     medications clonidine and gabapentin to see if they decrease the amount of opioid pain~     medications needed after surgery, thereby reducing opioid-related side effects, and time~     required to return to normal activities of daily living after surgery.~   "
187265|NCT01113385|"~     Focal Segmental Glomerulosclerosis (FSGS) is a devastating kidney disease which is difficult~     to treat and carries a poor prognosis, with 50% of affected children progressing to end stage~     renal disease (ESRD). The purpose of this study is to investigate oral galactose as a benign~     treatment for FSGS in children. The investigators hypothesize that galactose, a simple milk~     sugar thought to bind to the protein factor (FSPF) that causes FSGS thereby inactivating it~     and stopping it from damaging the kidney, resulting in a reduction in glomerular permeability~     to albumin and decrease in proteinuria in children with nephrotic syndrome secondary to FSGS.~   "
187266|NCT01113372|"~     Prospective, multicenter, randomized (two-arm 1:1), non-inferiority clinical evaluation~     comparing 2 regimes of dual antiplatelet therapy (DAPT) with aspirin + clopidogrel following~     percutaneous coronary intervention (PCI) with Endeavor Zotarolimus eluting stent (ZES) to~     evaluate the impact of different regimes of DAPT on clinical outcomes in minimally selected~     patients from the real-world clinical practice receiving the Endeavor ZES for the treatment~     of coronary artery lesions. Patients undergoing percutaneous treatment with the Endeavor ZES~     will be randomized in a 1:1 ratio to 2 regimens of DAPT including oral clopidogrel 75mg/day~     for 3 months versus 12 months.~   "
187267|NCT01113359|"~     It has been reported that mouse cytomegalovirus infection alone can elevate the blood~     pressure in mice. Since HCMV has uniquely evolved with its human host, with little genetic~     similarity to the animal CMV counterparts, and it only replicates in human, an~     epidemiological study is required to define the relevance of HCMV infection and expression of~     hcmv-miRNA-UL112 to the pathogenesis of essential hypertension.~      The investigators found that hcmv-miR-UL112, a human cytomegalovirus (HCMV)-encoded miRNA,~     was highly expressed in the hypertensive patients. Among the top miRNA target predictions,~     the investigators demonstrate that IRF-1 is a direct target gene of hcmv-miR-UL112, along~     with MICB that has been previously reported. Both IRF-1 and MICB play critical roles in~     immuno/inflammatory and anti-infection response. Thus, the investigators speculated that~     IRF-1 and MICB repression by hcmv-miR-UL112 could be considered a unifying mechanism that~     evades the host response at several levels: antiviral, inflammatory, and immune. In addition,~     there is an increasing evidence that IRF-1 may be important in apoptosis, angiogenesis,~     neointima formation and the pathogenesis of vascular diseases. IRF-1 can up-regulate~     angiotensin II type 2 receptor (AGTR2) that exerts antiproliferative and proapoptotic actions~     and affects regulation of blood pressure. It has been reported that the targeted disruption~     of the mouse AGTR2 gene resulted in a significant increase in blood pressure and increased~     sensitivity to angiotensin II. The nitric oxide synthase expression and NO synthesis in~     macrophages and distinct cardiomyocytes are induced and controlled by IRF-1 in response to~     inflammation, important steps in vascular biology that may improve endothelial function and~     inhibit smooth muscle cell migration, and a key pathophysiological event in hypertension.~     Collectively, these reports support a strong relationship between IRF-1 regulation and~     hypertension, indicating a potential role of hcmv-miR-UL112 and HCMV infection in the~     pathogenesis of hypertension.Thus, the investigators want to investigate the potential link~     between HCMV infection and essential hypertension.~   "
187268|NCT01113346|"~     This is a phase II double blind multicenter randomized placebo-controled clinical study aimed~     to find out whether treatment with Filtrum-STI (orally administered 0,4g tablets) is safe and~     effective in children with viral gastroenteritis. Filtrum-STI (lignin hydrolytic) is a drug~     with a high absorbing ability, that binds and eliminates toxins, pathogenic microorganisms~     and viruses. Filtrum-STI is inoffensive for mucous membranes, enhances colonic propulsion and~     improves its natural microflora. The drug is not toxic and well combines with other~     medication~   "
187269|NCT01113333|"~     Primary Objective:~        -  Assess the safety and tolerability of single intra-articular doses of SAR113945 in~          patients with knee osteoarthritis.~      Secondary Objective:~        -  Assess systemic exposure of SAR113945 following intra-articular delivery.~   "
187270|NCT01113320|"~     Approximately twenty four (24) subjects will participate in this research trial. The research~     trial will be conducted in approximately twelve (12) medical centers in the following~     countries: Germany, France, South Africa, Austria and Canada. The research trial will last~     until December 2011.~   "
187271|NCT01113307|"~     The primary objective of the study is to define procedures for the use of CureXcellTM in the~     community through Clalit Health Services. Secondary objective is to evaluate the blinding~     method in a subgroup of patients, which will be used in a future study named: a~     multinational, multi-center, randomized, double blind, placebo controlled study for the~     evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer~     treatment, in diabetic patients with ulcers in the lower extremities.~      Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post~     operative ulcer will be recruited to the study. Patients that have been recruited for the~     study will be treated as required for their medical condition. As required, cultures will be~     taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will~     be referred to catheterization, revascularization, or amputation as required and the decision~     to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct~     treatment to good ulcer care (GUC).~   "
187272|NCT01113294|"~     To compare the efficacy of different procedures, identify the optimal procedure, ablation~     sites, ablation endpoints and post-operative anticoagulation strategy, establish the optimal~     treatment strategy for atrial fibrillation.~   "
187273|NCT01113281|"~     Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing~     BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against~     tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas.~     The new vaccine should be at least as potent as the current strain and should be safer than~     BCG (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised~     bacteria to be re-suspended before intradermal injection. The preceding clinical trial in 80~     volunteers in Germany indicated immunogenicity and safety being sufficient for proceeding~     with the clinical development. Hence, the current study is commenced in South Africa, a~     country highly endemic for tuberculosis.~      24 volunteers were randomly allocated to 4 groups each with 6 adult healthy volunteers.~   "
187274|NCT01113268|"~     Our main goal is to create a prospective cohort of 1500 patients with a first large~     myocardial infarction allowing us, in a second step, to identify susceptibility genes for the~     progression of patients towards chronic heart failure using a candidate gene/candidate~     pathway approach. Our main hypothesis is that there is, for a given initial biomechanical~     stress (duration of the ischemic episode, size of the infarcted area, etc.), a variation in~     the individual susceptibility to develop left ventricular remodelling and to progress towards~     heart failure, and that this variation is linked to genetic variants between individuals.~   "
187275|NCT01113255|"~     The purpose of this study is to evaluate the ability of a device reproducing patients'~     respiratory characteristics to select in-VITRO the most appropriate ventilator for a given~     pathology.~   "
187373|NCT01111968|"~     This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity~     of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.~   "
187276|NCT01113242|"~     Cognitive disorders in Parkinson's disease (PD) are not as obvious as cognitive disorders in~     Alzheimer disease and their diagnosis tends to be delayed. If neuropsychological assessment~     of cognitive decline in Parkinson's disease is well established, the thresholds of cognitive~     testing corresponding to a dementia are unknown. Recently, new diagnosis criteria of dementia~     associated with PD have been proposed by the movement disorder society. In this study two~     groups of patients with idiopathic PD will be separated and compared according to their Mini~     Mental State Examination (MMSE) score (upper or lower than 26). Included patients will have~     clinically idiopathic PD, will be over 65 years old and will present cognitive complain.~     Cognitive and mood disorders as well as motor symptoms will be assessed using validated~     scales and a neuropsychological assessment dispatched in two visits will be performed .~     Differences in the distribution of data from the two groups of patients will be assessed in~     statistically analysis with non parametric tests. The purpose of this study is to determine~     the most effective tests and their threshold value corresponding to a pathological cognitive~     decline.~   "
187277|NCT01113229|"~     To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum~     haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.~   "
187278|NCT01113216|"~     This research is being done to find the genes and other factors that are responsible for~     differences among persons with cystic fibrosis. We are particularly interested in the factors~     that relate to the development of Cystic Fibrosis Related Diabetes (CFRD).~   "
187279|NCT01113203|"~     The study aimed to evaluate the chronic and acute effects of high-intensity resistance~     training on blood pressure and its hemodynamic and neural determinators in healthy~     normotensive older subjects.~   "
187280|NCT01113190|"~     Screening, brief interventions, and referral to treatment (SBIRT) for drug use/abuse offers~     opportunities for early detection, brief intervention/treatment, and substance use treatment~     referrals for patients in medical settings. Although SBIRT components, particularly screening~     and brief interventions, have been shown to be effective strategies for addressing alcohol~     misuse in primary care, data are limited on using all of the components of SBIRT for~     drug-using patients, particularly in the Emergency Department (ED). Further, because of the~     often chaotic environment of EDs, many logistical and practical impediments exist for the~     adoption of the entire SBIRT model in this setting.~   "
187281|NCT01113177|"~     Temporomandibular joint (TMJ) arthritis is known to alter the mandibular development in~     children diagnosed with juvenile idiopathic arthritis. In a number of cases a genuine~     breakdown of cartilage and bone is seen in the affected joint which leads to asymmetric~     mandibular growth in the affected side. In cases of unilateral TMJ involvements severe~     mandibular asymmetric mandibular growth deviations are seen. We hypothesize that these growth~     deviations can be minimized and controlled by the use functional orthodontic appliance~     therapy.~   "
187282|NCT01113164|"~     Sertraline, a serotonin-specific reuptake inhibitor (SSRI) that increases basal serotonin~     levels, was shown to reduce alcohol consumption in lower risk/severity and later onset (LOA)~     but not higher risk/severity earlier onset alcoholic individuals (EOA). By contrast,~     ondansetron, a 5-HT3 receptor reduced alcohol consumption in EOAs but not LOAs. To explain~     this contrast in clinical efficacy, one approach suggests that differential serotonergic~     response is based on a functional polymorphism of the 5-HTTLPR promoter region of the~     serotonin re-uptake transporter (SERT). These alleles have typically been classified as~     biallelic genotypes: LL, SS and SL. The LL variant is postulated to be associated with EOA~     and the SS/SL variants associated with LOA. To test this hypothesis the investigators~     therefore propose to match and mismatch serotonergic treatments to genetic polymorphic~     variants [in 132 non-treatment seeking alcohol dependent volunteers] in a double-blind~     placebo controlled 2 x 2 design human laboratory study. The investigators propose to~     randomize non-treatment-seeking alcohol dependent persons based on their 5'-HTTLPR variant~     genotype (LL or SS/SL) into one of two counterbalanced arms: participants in the first arm~     (LL) will first receive one drug (either 200mg/day of sertraline or ondansetron 0.5mg/day)~     for three weeks followed by an alcohol self-administration experiment (ASAE), [with a 1 week~     down-titration period if sertraline received first, during the first week of the placebo~     period] then receive placebo for two more weeks (this will be a single-blind portion to use~     as a comparison group and to wash out the pharmacodynamic effects of the first drug) followed~     by a second ASAE. Participants will then receive the second drug for three weeks followed by~     a third ASAE [all will receive medication for an additional 1 week period and those receiving~     sertraline last will be down-titrated]. Participants in the second arm (SS/SL) will receive~     the same medications in the same balanced design. Individuals in both arms will receive~     weekly medication management to enhance medication adherence. The long-term objective of this~     research is to prospectively examine serotonergic treatment matching for alcohol dependence~     based on genotyping. Of equal importance, the investigators also recognize the strong~     contribution of additional genetic and environmental influences on alcohol consumption.~   "
187283|NCT01113151|"~     The present study is part of a project titled 'Magnesium in asthma and chronic obstructive~     pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement~     will benefit patients with asthma and chronic obstructive pulmonary disease.~      The aim of this part of the project is to reveal possible beneficial effects of daily~     magnesium supplement for severe asthmatics, refractory to conventional treatment.~   "
187284|NCT01113138|"~     The present study is part of a project titled 'Magnesium in asthma and chronic obstructive~     pulmonary disease'. The hypothesis of the main project is that daily magnesium supplement~     will benefit patients with asthma and chronic obstructive pulmonary disease.~      The aim of this part of the project is to study the pharmacokinetics of the following two~     magnesium supplements:~        -  Mablet (dietary supplement)~        -  Magnesium Sulfate (solution for infusion)~   "
187285|NCT01113125|"~     Most children with cancer need a central venous catheter. These catheters are typically~     placed on the anterior thorax, where the risk of hypertrophic scarring and keloid development~     is greatly enhanced. A significant part of the children who have survived childhood cancer~     are troubled by their scars.~      Topical glucocorticoid treatment is known to induce a reduction of the collagen in the~     connective tissue.~      The investigators hypothesize that treatment with topical glucocorticoids for one week before~     and three weeks after removal of a central venous catheter, will reduce the formation of~     hypertrophic scarring and keloid development in children.~   "
187286|NCT01113112|"~     The purpose of this study is to understand relationships between behavioral factors,~     hormones, and chemicals produced by the body that may help tumor growth in ovarian cancer.~   "
187287|NCT01113099|"~     We hypothesize that when compared to usual care a greater proportion of hospitalized diabetic~     patients who are candidates for cholesterol lowering will be discharged with a prescription~     for a statin if their physicians are contacted by a pharmacist to discuss treatment~     guidelines.~   "
187305|NCT01112865|"~     Convenience and preference for the new Mark VII pen compared to the current Genotropin pen~     will be assessed using a questionaire. it is expected that the new pen will be preferred or~     at least no different to the current pen.~   "
187289|NCT01113073|"~     Fluid administration is a daily intervention on the intensive care unit to improve cardiac~     output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume~     status of the patient is very difficult to assess. Too little volume leads to inadequate~     organ perfusion followed by ischemia and organ failure. Too much volume may worsen heart~     failure and cause pulmonary and peripheral edema and contribute to further tissue injury and~     organ dysfunction. Although dynamic indices have been shown to be more accurate predictors of~     fluid responsiveness, this relevant and complex task is usually guided by static clinical~     variables and the specialist's interpretation due to the fact that the interpretation of~     dynamic parameters is not fully developed and that they are not universally available. This~     lack of understanding is partially because of the complex interaction with mechanical~     ventilation. The investigators hypothesize that knowing the distribution of ventilatory~     pressures will make it possible to index dynamic parameters to tidal volume and improve their~     predictive value concerning the volume status of the patient. In addition, it would be of~     interest to be able to predict fluid responsiveness in a non-invasive way, especially in~     critically ill patients. Up to now, continuous non-invasive cardiac output monitoring using~     Nexfin in critically ill patients has not been validated and also not tested for its ability~     to predict fluid responsiveness. The present research proposal evaluates the possibility and~     accuracy of the model flow analysis obtained by non-invasive finger arterial pressure~     measurements to determine fluid responsiveness using passive leg raising. It will also be~     compared to a more invasive method (that is currently used in the clinic) to assess its~     ability to measure absolute CO levels accurately. It may make it possible to assess fluid~     responsiveness in a non-invasive and patient friendly way.~   "
187290|NCT01113060|"~     Aspirin is an effective medicine for prevention of heart attacks in patients with coronary~     artery disease and works by preventing clots from forming. In previous studies aspirin has~     been found to be ineffective in between 2% and 65% of patients but none of these studies have~     looked specifically at coronary artery disease patients in Ireland. This study is being done~     to identify the percentage of patients in Ireland whose aspirin is not working effectively~     and help identify factors that could be used to target interventions to increase aspirin's~     effectiveness in Irish patients.~   "
187291|NCT01113047|"~     This study will assess the efficacy and safety of the single pill combination of Aliskiren~     and Amlodipine in patients with moderate hypertension not adequately responding to a single~     pill combination of Olmesartan and Amlodipine.~      Further this study will also assess the efficacy and safety of a single pill combination of~     Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension~     not adequately responding to a single pill combination of Aliskiren and Amlodipine.~   "
187292|NCT01113034|"~     The primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled~     asthma or bronchiectasis.~   "
187293|NCT01113021|"~     The hypothesis of this study is that a chronic program of physical strength~      training, associates to effects of low level laser therapy (LLLT) can,~      possibly, provide changes in genic expression of muscle and to promote an~      enhancement of anaerobic muscle performance in humans.~   "
187294|NCT01113008|"~     The aim of this study is to evaluate the phenomenon of remote ischemic post-conditioning in~     humans. The minor myocardial damage associated with percutaneous revascularization procedures~     may be attenuated by producing controlled ischemia in the arms immediately after carrying out~     these procedures (remote ischemic post-conditioning). The justification and design of this~     clinical trial has been reported: Cardiology. 2011;119(3):164-9.~   "
187295|NCT01112995|"~     The purpose of this study is to investigate the feasibility, safety and efficacy of oral~     probiotic, Lactobacillus rhamnosus versus oral placebo for reducing colonization by MRSA.~   "
187296|NCT01112982|"~     The purpose of this study is to show that patients with gout suffer from chronic inflammation~     of their joints, observable by MRI, even in the absence of symptomatic gouty attacks.~     Secondary end-points of this study will include analyzing the effects of uric acid-lowering~     therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients,~     checking for the presence of inflammatory markers to see if there is any correlation with the~     proposed chronic inflammation, and evaluating for other characteristic findings of gout on~     MRI.~   "
187297|NCT01112969|"~     This is an intervention study for informal caregivers of adult patients with an acquired~     brain injury (stroke, traumatic brain injury or cerebral haemorrhage). It will determine~     whether an internet-based supportive coaching offers benefits to the caregivers in their own~     process of coping in the aftermath of a brain injury of a close relative. We expect the~     internet-based supportive coaching to be more effective in the treatment of emotional~     distress reactions and caregiver burden than the treatment as usual.~   "
187298|NCT01112956|"~     The purposes of this study are:~        -  To determine the accuracy of commercially available serologic assays in diagnosing~          patients with herpes simplex virus type 2 (HSV-2);~        -  To assess the sensitivity and specificity of the commerical assays using HSV-2 western~          blot as the gold standard in a diverse patient population;~        -  To develop testing strategies and recommendations for screening asymptomatic populations~          for HSV-2.~   "
187299|NCT01112943|"~     The hypothesis of this study was that acupuncture in conjunction with standard care of~     pulmonary rehabilitation improves outcome measures compared to pulmonary rehabilitation~     alone.~   "
187300|NCT01112930|"~     In humans, docosahexanoic acid (DHA) is concentrated in brain. After birth, DHA is obtained~     from breast milk or the child's diet. The investigators are studying whether DHA intakes in~     young children are adequate to support brain development. This is a cross-sectional study of~     children 5-6 years-old.~   "
187301|NCT01112917|"~     The investigation is designed to verify that clinical use of the vena cava filter does not~     raise new questions of safety or effectiveness compared to currently-marketed permanent~     filters.~   "
187302|NCT01112904|"~     Docosahexanoic acid (DHA) is concentrated in the human brain. Before birth, DHA is~     transferred across the placenta, but transfer depends on maternal DHA intake. After birth,~     DHA is provided by breast milk or the child's diet. This study addresses whether DHA intakes~     are adequate to support human brain development.~      In a previous study N-3 Fatty Acid Requirements for Human Development (C03-0242), pregnant~     women were randomly assigned to 400 mg/day DHA or placebo from 16 weeks of gestation until~     infant delivery. Blood DHA in gestation, and infant development to 18 months were assessed.~     This follow-up study will assess if maternal DHA in gestation has long-term influence on~     child development when assessed at 5 years and the impact of the child's own diet.~   "
187303|NCT01112891|"~     Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and~     infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during~     pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and~     baby reach a vitamin D serum concentration of 25OHD>75nmol/L.~   "
187306|NCT01112852|"~     Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better~     than either vasoconstrictor or endoscopic therapy alone in achieving the successful~     hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance~     the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation~     (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of~     choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve~     hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding~     due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal~     ulcers and bleeding by a proton pump inhibitor may be more logical than using a~     vasoconstrictor after cessation of bleeding by EVL.~   "
187307|NCT01112839|"~     The purpose of the ENERGY trial is to explore whether two different programs that are focused~     on weight management, through increased exercise and a healthy diet, are feasible, and have~     an impact on body weight, quality of life and fatigue. Since obesity among breast cancer~     survivors is associated with recurrence and other co-morbidities, those will be assessed and~     their impact calculated. Blood samples will be collected to enable analysis of potential~     mechanisms and differential response across subgroups.~   "
187308|NCT01112826|"~     The primary objective of this study is to compare disease-free survival (DFS) of patients~     with triple negative breast cancer randomised to treatment with standard adjuvant~     chemotherapy alone or to standard adjuvant chemotherapy followed by 1 year of Capecitabine~     (Xeloda) metronomic therapy.~   "
187309|NCT01112813|"~     Stroke is the leading cause of adult disability and the third leading cause of death in~     Canada. Most stroke survivors live with residual impairments that diminish independence and~     quality of life. This may include vascular cognitive impairment (loss of ability to plan,~     think and reason) which can lead to dementia and loss of mental and functional independence.~      The current treatment to reduce stroke induced brain tissue injury is limited to~     thrombolytics (clot busters), a therapy useful only if given in the first hours following~     stroke. One major new approach aims to reduce cell death after stroke by targeting the~     ongoing tissue loss initiated by the stroke. The tissue can be maintained by interfering with~     later neurochemical processes that are activated by stroke, potentially through activating~     natural substances in the brain that help survival and growth of nerve cells (neurotrophic~     factors).~      The recent recognition of lithium as a neurotrophic agent has generated the first studies of~     lithium treatment for managing brain diseases. Clinically, lithium has now been shown to~     increase brain gray matter volume in bipolar patients. This effect is potentially important~     in stroke because gray matter loss has been implicated in the development of cognitive~     impairment after stroke, a result of the series of brain processes that are activated by lack~     of oxygen due to stroke. Our primary objective is to examine the effects of lithium on total~     brain gray matter volume in the post-stroke population, as measured by volumetric magnetic~     resonance imaging (MRI) with the hope that lithium may increase gray matter volume in~     post-stroke patients and lead to greater cognitive and functional rehabilitation. This study~     will provide valuable information on the tolerability of lithium, and its effects on clinical~     outcomes relevant to stroke, providing the information needed for designing a large-scale~     clinical trial.~   "
187310|NCT01112800|"~     Anthracycline antibiotics are included in the chemotherapy regimens of approximately 82% of~     patients with bone cancer and 44% of those with soft tissue sarcoma diagnosed in childhood or~     adolescence. Impaired cardiac function occurs after treatment with anthracyclines. The~     frequency of impairment increases with increasing cumulative dose. There are inadequate data~     regarding the relationship between doxorubicin administration and changes in serum levels of~     cardiac troponin T (cTn-T) or I (cTn-I), N-terminal (NT) brain natriuretic peptide (BNP), or~     tissue Doppler imaging parameters.~      This non-therapeutic study proposes a prospective, single arm study of serial changes in~     tissue Doppler imaging parameters, cTn-T and NT-BNP in children and adolescents with~     malignant bone and soft tissue tumors whose planned chemotherapy includes treatment with ≥~     375 mg/m2 of doxorubicin.~      The proposed study will rigorously evaluate the usefulness of serial determinations of tissue~     Doppler imaging, cTn-T and NT-BNP for very early identification of anthracycline-related~     myocardial injury. Demonstration that one or more of these markers identifies subclinical~     myocardial damage and that biomarker or tissue Doppler imaging parameters exhibit a~     dose-response relationship with cumulative doxorubicin dose would facilitate intervention~     trials in patients at risk for anthracycline cardiomyopathy.~   "
187311|NCT01112787|"~     The purpose of this study is to evaluate the irritation level of tazarotene foam after 21~     days of exposure on the skin of healthy volunteers.~   "
187312|NCT01112774|"~     The purpose of this study is to determine whether the novel treatment of transcranial direct~     current stimulation (tDCS) could decrease the pain perception of those with spinal cord~     injury.~      We will also determine whether these changes are correlated with the clinical outcome (pain~     reduction).~   "
187313|NCT01112761|"~     The purpose of this research is to determine whether athletes with concussion have changes in~     cortical excitability.~      Single and paired transcranial magnetic stimulation (TMS) can be used as reliable~     neurophysiological marker of motor cortex reorganization in athletes with concussions.~      This study also aims to determine whether modulation of cortical activity by a powerful~     technique of noninvasive brain stimulation (tDCS) results in a different cortical response as~     compared with sham tDCS.~   "
187314|NCT01112748|"~     The primary purpose is to study the predictive value of preserved nociceptors and large~     afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch. The~     primary outcome measure is the predictive role for these three measures for obtaining a~     response to lidocaine. A responder is defined as a person with at least a 2-point pain~     reduction to lidocaine (change in median pain intensity (measured on a 10 point numeric~     rating scale) of pain from the baseline week to the last week of lidocaine treatment).~     Secondary effect variable will be efficacy of lidocaine on pain reduction (baseline week~     versus last week of each treatment) and pain relief (complete, good, moderate, slight, none,~     or worse) for spontaneous and evoked pain, and effect on ongoing pain, brush evoked~     allodynia, cold and warm allodynia, and pinprick hyperalgesia evaluated on each visit.~   "
187315|NCT01112735|"~     The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of~     care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing~     abdominoplasty.~   "
187316|NCT01112722|"~     The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with~     diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using~     Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global~     Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week~     treatment period after randomization into the trial. Secondary efficacy is improvement of~     mobility Treatment effect will be compared in a 2-1 Apitox vs active control~   "
187319|NCT01112683|"~     The purpose of this 16-week research study is to determine whether a drug called memantine~     hydrochloride (memantine) has the potential to help improve memory and other cognitive~     abilities of young adults with Down syndrome (DS). Memantine (Namenda®) is a drug approved by~     the Food and Drug Administration (FDA) for patients with moderate to severe Alzheimer-type~     dementia. About 40 persons of both genders with Down syndrome aged 18-32 years will take part~     in this study. This is a randomized and double blind study. This means that subjects will~     have a 50/50 chance of being assigned to receive either the memantine pills or placebo~     (inactive pills). Neither the study participants nor the research personnel will know who is~     receiving active medication or placebo. Based on memantine's mode of action, current~     knowledge on brain pathology in persons with Down syndrome, and some preclinical data on~     mouse models of Down syndrome, we hypothesize that memantine may improve test scores of young~     adults with Down Syndrome on memory tests targeted at the function of the brain structure~     called the hippocampus. This research project has three specific aims: 1) investigate whether~     memantine has the potential to improve test scores on hippocampus-dependent measures in young~     adults with Down syndrome; 2) investigate whether memantine has the potential to improve test~     scores by these subjects on other cognitive measures; 3) investigate whether memantine is~     well tolerated by these subjects.~   "
187320|NCT01112670|"~     The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and~     drug-drug interactions of sitagliptin therapy.~   "
187321|NCT01112657|"~     This is a prospective, multicentric, observational study with a 2 years recruitment period.~     The purpose of the study is to observe the multiple sclerosis (MS) progression of subjects~     since their first episode of neurological event and secondly, to determine status of~     anti-AQP4 immunoglobulin (IgG) antibody in MS subjects.~   "
187322|NCT01112644|"~     The primary objective for the 12-week Titration-/Maintenance Period is:~      To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom~     severity of RLS.~   "
187323|NCT01112631|"~     The patients from 12 centers were included into the study. pN2 patients received PORT, pN1~     patients did not. PORT was 3D-planned and consisted in 54-56 Gy in 27-28 fractions. One month~     after surgery, all patients completed EORTC QLQ C-30 questionnaires and had pulmonary~     function tests (PFT); cardiopulmonary symptoms were assessed by modified LENT-SOM score. Two~     years after, all patients free of disease repeated the same examinations. Changes in QLQ,~     LENT-SOM score and the results of PFT were compared for patients receiving and not PORT.~   "
187324|NCT01112618|"~     This non-interventional study is planned to identify the subjects with severe luteinizing~     hormone (LH) deficiency in the daily practice. The results will be used for the Periodic~     Safety Update Report, which is to be regularly sent to the European Medicines Agency (EMEA)~     and the responsible German Higher Federal Authority (BfArM).~   "
187325|NCT01112605|"~     The purpose of this study is to define the standardization of the distance between the Sural~     nerve & Achilles tendon, in otherwise healthy persons and athletes.~   "
187326|NCT01112592|"~     We aim to study if pathological NETs formation could be the underlying pathology among~     patients with recurrent infections and a normal screening of the immune system.~   "
187327|NCT01112579|"~     The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as~     a chronic therapy for systolic heart failure.~   "
187328|NCT01112566|"~     The goal of the study is to identify the patients suffering from a mitral valve condition who~     benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and~     long-term relief of mitral valve regurgitation.~   "
187329|NCT01112553|"~     We are looking for volunteers who suffer from acute migraine (<14 episodes per month) to~     participate in a 2-visit brain imaging research study. The goal of the study is to observe~     the effect of acute administration of Treximet during a migraine episode on the pain pathways~     of the migraine brain. Visit 1 will consist of 1 hour, where participants will be signing the~     informed consent form, completing questionnaires, meeting with the study physician, and~     having QST (sensory testing to determine individual pain thresholds to a heat stimulus)~     performed. Visit 2 will occur during a migraine episode. Volunteers will be asked to contact~     the study team at the first onset of a migraine. Upon arrival at Visit 2, individuals will be~     given an IV for blood draws. Once these the IV is in place, subjects will enter the MRI and~     be asked to stay very still. Scanning will occur for about 20 minutes, and then subjects will~     be given a Treximet tablet to combat their migraine. More scanning will follow Treximet~     administration. Some scans will have no stimulation, and others will apply a heat stimulus~     that subjects will rate using a pain scale. Seven 5-mL blood samples will be drawn throughout~     the duration of the MRI session. Both Visit 1 and Visit 2 will be compensated.~   "
187330|NCT01112540|"~     The investigators primary outcome measure was the clinically important change in diagnostic~     accuracy and physical examination in the morphine vs. placebo group. After follow up~     information was obtained and patients data were recorded on the SPSS data chart, two blinded~     coauthors (general surgeon and emergency physician) determined the clinically important~     diagnostic accuracy and change in physical examination. They firstly defined clinically~     important diagnostic errors, as any disagreement between the preliminary and final diagnosis~     that might be expected to have adverse effect on the patient's general status. If coauthors~     decided an instance of diagnostic error as clinically important, this was coded diagnostic~     discordance for statistical analysis. While the preliminary diagnosis was determined as~     accurate or not different from the final diagnosis, this was coded diagnostic accuracy for~     statistical analysis. Secondary outcome measures included the need for rescue drugs at 30~     minutes, the presence of at least one adverse event, demographic features and final diagnosis~     of the patients.~   "
187331|NCT01112527|"~     There are three arms to this study (A, B and C) The purpose of this research study during Arm~     A is to see how much of PF-00299804 gets into the brain tumor. For many brain tumors, one~     reason that chemotherapy drugs might not be effective is that the drug may not be able to get~     into the brain tumor and kill the cancer cells. We will determine how much PF-00299804 gets~     into the brain tumor by obtaining a sample of the tumor from the surgery that the participant~     already has scheduled. The purpose of this research study during Arm B and C, is to determine~     how well PF-00299804 works in killing cancer cells. PF-00299804 works by binding to specific~     proteins found on the surface of some cancer cells that promote a growth signal. Blocking~     this signal from reaching its target on the cancer cells may slow or stop the cancer from~     growing.~   "
187332|NCT01112514|"~     Standard white light endoscopy involves the passage of a thin, flexible camera into the colon~     from the anus. Although standard white light endoscopy can detect most polyps and~     precancerous areas in the gastrointestinal tract and colon, many studies have shown that even~     the most experienced doctors, under optimal conditions, can miss up to 15-25% of precancerous~     areas. Thus, there remains a clear need to develop new methods of improving standard white~     light endoscopy. We are investigating whether indocyanine green (ICG) can serve to highlight~     areas which are precancerous when the colon is visualized with a special cameral which shines~     fluorescent light. Information from other studies suggests that this ICG agent may help to~     visualize blood vessels flowing to precancerous areas in the colon. We are looking at the~     ability of ICG, in combination with an endoscope which shines fluorescent light, to visualize~     precancerous areas in the colon.~   "
187333|NCT01112501|"~     Aim of the study is to evaluate whether Tc-99m-ECD-SPECT/CT enhances early diagnosis of~     dementia in two specific patient groups: (1) patient with mild cognitive impairment, and (2)~     patient with possible symptoms and signs of frontotemporal dementia. Evaluation of SPECT/CT~     data is performed both by visual and quantitative voxel-based analyses (Statistical~     Parametric Mapping). The final diagnosis is based on up to four years clinical follow-up.~   "
187334|NCT01112488|"~     Currently there is a lot of literatures on stroke rehabilitation and post-discharge therapy.~     However, there are few evidence based guidelines on patient engagement after stroke in the~     post-rehabilitation community phase. There is evidence from stroke studies that stroke~     patients with mild to moderate disability, discharged early from an acute hospital unit can~     be rehabilitated in the community by an interdisciplinary stroke rehabilitation team and~     attain similar functional outcomes when compared to patients receiving in-patient~     rehabilitation. There is strong evidence that additional hospital based outpatient therapy~     improves short term functional outcomes compared to routine care over short term. Although~     meta-analyses have examined the efficacy of self management education programs, the~     interpretation of such reviews is limited by heterogeneity in populations and interventions~     and the limited range of outcomes measured. Few randomized controlled trials have found a~     reduction in health service utilization, such as incidences of hospitalization (in patients~     with chronic lung disease, heart disease, stroke and arthritis) as a direct outcome of~     attending an education program. For self-management support to be effective and sustainable~     in the community, it is postulated that initiatives simultaneously focus on supporting~     patients to engage in self management and equipping health care professionals with the~     necessary resources to assist them.~   "
187335|NCT01112462|"~     This study is designed to assess bioequivalence between two paracetamol/ phenylephrine~     combination products.~   "
187336|NCT01112449|"~     Penn State Milton S. Hershey Medical Center researchers are trying to compare the effects of~     two different forms of selenium (selenium yeast and selenomethionine) on blood selenium~     levels and biomarkers of oxidative stress as primary endpoints. One in six men are at risk of~     getting prostate cancer in their lifetime. Participants will be asked to take~     over-the-counter selenium yeast supplements and selenomethionine or a placebo for nine out of~     twelve months.~   "
187337|NCT01112436|"~     This prospective randomized study aims to evaluate the effectiveness of periarticular~     multi-drug regimen injection on the relief of pain in patients undergoing partial hip~     replacement.~      Total 258 patients will be randomized into one of two groups (groupC or groupI) based on~     Excel number generation.~      Patients in group C will receive no medication intraoperatively, and patients in group I will~     receive oral oxycodone and celecoxib preoperatively and a periarticular injection of~     multi-drug regimen during operation.~      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients~     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 1, 4, 7~     postoperative day.~   "
187338|NCT01112423|"~     The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects~     on LDL cholesterol (LDL-C)~   "
187339|NCT01112410|"~     The investigators hypothesise that nebulised hypertonic saline (6%) will increase the volume~     of sputum expectorated over a 24 hour period compared to nebulised isotonic saline (0.9%) in~     patients with mild to severe stable bronchiectasis.~   "
187340|NCT01112397|"~     This study is being conducted to assess the safety, tolerability and PK of AZD1480 in~     patients with advanced solid malignancies.~   "
187341|NCT01112384|"~     The purpose of this study is to find out what effects a new drug SB939 has on you and your~     sarcoma.~      This research is being done because there is a need for better treatment options for advanced~     or recurring sarcoma.~      SB939 has been shown to shrink tumours in animals and some people and seems promising but it~     is not clear if it has any positive effects in sarcoma.~   "
187342|NCT01112371|"~     The purpose of this study is to investigate the efficacy of Contractubex® Gel, containing~     extractum cepae, allantoin and heparin, in the treatment of scars after abdominal Caesarean~     section compared to untreated scars after abdominal Caesarean section.~   "
187343|NCT01112358|"~     This was a prospective, randomised, comparative with parallel control, Phase 2 exploratory~     trial to assess the efficacy and safety of mid follicular Luveris in 60 women at risk of poor~     response undergoing COS prior to ICSI with Gonal-f and Cetrotide.~   "
187344|NCT01112345|"~     The present study aims to assess the adherence to therapy with interferon beta-1a (Rebif®)~     and at investigating potential factors that are involved in its outcome, in a representative~     sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life~     conditions.~   "
187345|NCT01112332|"~     The objective of this clinical trial is to determine normative Percentage~     Body-Weight/Weight-Bearing Values and Weight-bearing Gait Characteristics in different~     physiologic conditions~        1. Values in increasing speeds from walking to running.~        2. Changing resistance and incline on an elliptical trainer~        3. Ground jogging.~        4. Stair climbing.~        5. Treadmill running.~        6. Walking.~   "
187346|NCT01112319|"~     The objective of this clinical trial is to evaluate the pain relief and daily functioning~     improve, in patients suffering of Osteoarthritis of knee, with HOT/COLD/ Electro therapy~     during physiotherapy treatment~   "
187347|NCT01112306|"~     Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the~     safety and tolerability of ACT-293987 in patients with PAH who participated in the~     double-blind study AC-065A302 (GRIPHON)~   "
187348|NCT01112293|"~     This study is being conducted to evaluate the overall safety and effectiveness of an~     investigational drug, GC1008, in patients with mesothelioma. An investigational drug is one~     that has not been approved by the FDA. Approximately 40 people will be enrolled on this study~     at the University of Pennsylvania (Main Institution/Coordinating Site) and the University of~     Chicago (Participating Institution). We expect about 20 subjects to be enrolled at each~     institution.~   "
187349|NCT01112280|"~     The investigators plan to conduct a multi-center, randomized controlled trial to investigate~     the efficacy of cap-assisted chromoendoscopy as a screening test for colorectal polyp, and~     the impact on 3-year polyp recurrence rate. This study will be performed using web-based~     research network, e-VELOS in Korea.~   "
187350|NCT01112267|"~     The purpose of this study is to evaluate the efficacy and safety of extended release (ER)~     tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic~     (lasting a long time) low-back pain.~   "
187351|NCT01112254|"~     The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize~     resection of Ductal Carcinoma In Situ (DCIS) breast cancer.~   "
187352|NCT01112241|"~     This study has been designed to provide a substantial evidence of acute bronchodilator~     responsiveness to two sequentially inhaled drugs, a beta2-agonist (i.e., albuterol) and an~     anticholinergic (i.e., tiotropium bromide), in a group of patients who developed obliterative~     bronchiolitis after hematopoietic stem cell transplantation.~   "
187353|NCT01112228|"~     This study will assess various published staging tools to assess the health impacts of~     obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity~     Centres and GPs better assess obese individuals as well as better identify who benefits most~     from having weight loss treatment.~   "
187354|NCT01112215|"~     Azathioprine is still considered the treatment of choice for the non-renal manifestations of~     systemic lupus erythematosus (SLE) with an estimated efficacy of 45%.Recently, several~     studies have demonstrated the efficacy of mycophenolate mofetil/enteric-coated mycophenolate~     sodium in those cases, but so far, no controlled, randomized comparative study between the~     two drugs has been conducted. The aim is to perform a randomized, controlled, phase III/IV~     study comparing enteric-coated mycophenolate (ECMs) with azathioprine for induction and~     maintenance therapy of the non-renal manifestations of SLE. Methods: Patients with non-renal~     SLE flares (SLEDAI≥6 and/or BILAG o 2B refractory to full doses of hydroxychloroquine and~     prednisolone (≥10 mg/d) or with relapsing flares will be included. Patients will be~     stratified according the flare severity (moderate (SLEDAI<12)-severe (SLEDAI≥12)) and~     randomized (1:1) into two groups of treatment, EMCs (2gr/d) or AZA (2-2.5mg/kg/d) according~     to TMPT levels for 6 months. Dose will be progressively tapered based on clinical response up~     to completing a year of treatment. The main aim is the percentage of complete remission~     achieved ((SLEDAI <4 and/or absence of any BILAG A o B) at week 12 and 24 for moderate and~     severe flares, respectively. Secondary objectives include evaluating the reduction in the~     steroid requirement, number of flares post-treatment, effect on the biological parameters,~     and impact on quality of life, damage and drug safety. To detect a 20% difference between the~     two drugs with a 80% statistical power (0.05 alpha error), considering a follow up loss of~     20%, a total of 240 patients is required.~   "
187355|NCT01112202|"~     Dabigatran represent a new class of promising anticoagulation agents. As an oral direct~     thrombin inhibitor it has been effective in preventing venous thromboembolism in patients~     undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the~     ex-vivo effects of Pradaxa® on different coagulation parameters.~   "
187356|NCT01112189|"~     The post-mastectomy lymphedema is a complication of removal of the breast and nodal plexus~     that causes accumulation of lymph and subsequent enlargement of the upper limb. It is the~     most common complication of all attributable to mastectomy with axillary dissection and which~     occurs in one third of patients who undergo radical mastectomy and radiotherapy~     post-operation. Currently the treatment of lymphedema of the upper limb is mainly the use of~     compression stockings, the use of pneumatic compression pumps and physiotherapy.~      Multiple reports indicate that endothelial progenitor cells (EPC) can differentiate into~     various cell lines, reproduced and participate in neoangiogenesis. This study was conducted~     in the General Surgery Service, of the Hospital Universitario Dr. José Eleuterio González~     and proposes the EPC obtained autologous transplantation of bone marrow for the treatment of~     postoperative lymphedema in upper limb following axillary lymphadenectomy through the~     stimulation of lymphatic neoangiogenesis. The investigators studied 20 female patients over~     18 years after axillary lymphadenectomy. The objective is to develop an innovative and~     definitive treatment for these patients and to analyze the costs and complications that this~     treatment may have.~   "
187357|NCT01112176|"~     The current study is aimed at determining the normal response to increasing heart rates. For~     this purpose, atrial pacing will be used to increase heart rate.~   "
187358|NCT01112163|"~     Enhanced external counter pulsation (EECP) is a procedure performed on patients with ischemic~     heart disease. The treatment improves physical capacity and relieves angina pectoris. It is~     suitable for patients with persistent angina pectoris despite and for patients not amendable~     for coronary revascularization. Some studies demonstrate a relationship between diastolic and~     systolic blood pressure ratio (d/s ratio) and the effect of EECP.~      The aim of the investigators study is to understand the effect of EECP on left ventricular~     systolic and diastolic function assessed by trans-thoracic echocardiography (TTE).~      Hypothesis: EECP improves left ventricular systolic and diastolic function. There is a~     relationship between d/s ratio and aortic arterial stiffness EECP improves left ventricular~     diastolic function Standard TTE would be performed prior the EECP procedure, which lasts 60~     min., and repeated every 15 minutes. Moreover the investigators would measure pulse wave~     velocity, a measure of aortic arterial stiffness, in order to investigate the relationship~     between the d/s ratio and arterial stiffness.~      The patients would be recruited among former study patients who have undergone EECP before.~     20 patients with the best acoustic conditions would be selected and invited to enroll into~     the study.~   "
187374|NCT01111955|"~     The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects~     on fasting plasma glucose (FPG).~   "
188964|NCT01091103|"~     This study is being conducted to determine the effect of enzalutamide on the androgen~     signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify~     potential predictors of response or resistance to therapy.~   "
187359|NCT01112150|"~     The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec~     pump, patients will lose weight, will feel better, will be less prone to infections in their~     legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the~     mobilized edema fluid returned to the intravascular space by pumping may increase cardiac~     output and renal perfusion and in addition it may distend the right atrium and ventricle thus~     inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.~   "
187360|NCT01112137|"~     Context: Soluble CD40 ligand (sCD40L) released from activated platelets induces inflammatory~     transformation of the vascular endothelium and is an independent predictor of cardiovascular~     events. Arterial hypertension is associated with platelet activation, increased sCD40L levels~     and endothelial dysfunction suggesting that inhibition of platelet-derived sCD40L release may~     improve endothelial function and lower blood pressure (BP).~      Objective: To determine the effects of clopidogrel on sCD40L, endothelial function and BP.~      Design: Randomized, controlled, investigator-blinded, parallel-group, 2-phase trial in~     patients with coronary artery disease and essential arterial hypertension and those without~     hypertension.~      Intervention: Participants receive a single 600-mg clopidogrel loading dose (phase I)~     followed by a daily 75-mg clopidogrel maintenance dose over 28 days (phase II).~      Outcome Measures: Primary outcome measure is the change in BP from baseline. Secondary~     outcome measures are changes in biomarkers of platelet and endothelial function and their~     correlation with BP.~   "
187361|NCT01112124|"~     The purpose of this study is to assess the typical behavior of children ages 15 months to~     five years around a microwave oven. The UCH Burn and Complex Wound Center has observed scald~     burn injuries in young children operating and/or removing hot liquids from microwave ovens.~     The knowledge we hope to gain is the developmental age that a child is able to open and/or~     operate a microwave oven safely. This work may influence future microwave oven design to~     protect young children from microwave-related scald burn injuries. These injuries have~     resulted in visits to the emergency room, stays in the hospital and debridement and skin~     grafting procedures in the operating room.~   "
187362|NCT01112111|"~     This study is designed to compare the efficacy of a novel stimulation protocol with the~     conventional low dose step-up and step down regimens in older than 30 years PCOS patients~     undergoing in vitro fertilisation. The novel regime was proposed under the basis of the~     combined effectiveness of the two standard protocols to induce a uniform follicular growth~     and forms a continuation to the author's previously published results examining a similar~     approach in younger PCOS candidates. In total 225 patients have been recruited for this~     study. The stimulation protocol will be assigned under the basis of prospective randomization~     using sealed and numbered envelopes. All patients will be down regulated using a~     desensitisation agent administered on day 2 of spontaneous or induced withdrawal bleeding.~     The initial dosage in the low dose step-up regimen (group A) will be 150 IU/d of FSH for the~     first 6 days followed by an increase of 75 IU thereafter. In the step-down regimen (group B)~     patients will administer a starting dose of 300 IU/d of FSH for the first 3 days followed by~     a decrease to 225 IU/d for the next 3 days. This dosage will be further decreased to 150 IU/d~     or sustained at 225 IU (according to the initial response) until the day of the hCG~     injection. Group C, patients received 225 IU on day 1 followed by a decrease to 150 IU on day~     2. On day 3 the dosage will be increased back to 225 IU. This alternation of injection dosage~     will be followed until day 6. According to the initial ovarian response the dosage will be~     sustained at 225 IU/d or 150 IU/d until the day of the hCG injection. The 10,000 IU hCG will~     be administered when at least two follicles had reached a mean diameter of 18 mm and the~     serum E2 levels were consistent with the ultrasound findings. Egg retrieval will be~     undertaken at 35 hours after the administration of the hCG injection. Oocytes recovered will~     be inseminated 4 hours post egg collection. Patients will receive 3 embryos on the third day~     of development. The luteal phase will be supported by progesterone suppositories starting on~     the day of the egg collection. A positive outcome will be detected by a serum β-hCG analysis~     13 days after embryo replacement. The presence of a fetal heart pulse on ultrasound 3 weeks~     later confirmed a clinical pregnancy.~   "
187363|NCT01112098|"~     The purpose of this exploratory study is to test novel, mailed, low-cost, direct-to-patient~     intervention materials (i.e., a personalized letter and osteoporosis information pamphlet)~     designed to increase rates of dual energy X-ray absorptiometry (DXA) utilization and improve~     osteoporosis quality of care.~   "
187364|NCT01112085|"~     The objective of this study is to investigate if the drug ranibizumab administrated by~     microdose injection into the eye is safe and effective to treat diabetic macular edema.~   "
187365|NCT01112072|"~     This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with~     Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease~     the progression of keratoconus, while Intacs has been shown to decrease corneal steepness in~     keratoconus. This study will attempt to determine the relative efficacy of the two procedures~     either performed at the same session versus CXL performed 3 months after Intacs.~   "
187366|NCT01112059|"~     The purpose of this study is to examine the role of a well-known and well-tolerated~     antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized.~     This antibiotic does not effectively treat the bacteria in airways of cystic fibrosis~     patients, but may reduce the activity of inflammatory molecules in the disease.~   "
187367|NCT01112046|"~     This is a prospective randomized trial that aimed to compare the short-term clinical outcomes~     and systemic inflammatory/cytokine responses of endoscopic submucosal dissection versus~     laparoscopic resection for early colorectal neoplasms that are not amenable to en bloc~     endoscopic resection with conventional techniques.~   "
187368|NCT01112033|"~     In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in~     HCV infected patients prior and during/after standard antiviral therapy in association with~     viral clearance, disease progression and treatment response and in comparison with healthy~     subjects.~   "
187369|NCT01112020|"~     The purpose of this study is to determine the contents of a chlorhexidine-containing dressing~     after use.~   "
187370|NCT01112007|"~     The purposes of the study are to evaluate the relative contributions of insulin resistance~     and renin-angiotensin-aldosterone system to blood pressure (BP) in subjects with~     prehypertension. This is a cross-sectional study. Anthropometric and BP measurements will be~     performed in 50 prehypertensive subjects. The subjects will receive a 75-g oral glucose~     tolerance test and a postural stimulation test for the measurements of insulin resistance,~     plasma rennin concentration and aldosterone level. Log (ISI0,120), an insulin sensitivity~     index from the oral glucose tolerance test, will be calculated. Statistical analyses will be~     performed to compare the degree to which aldosterone and Log (ISI0,120) predicted systolic~     and diastolic BP in these prehypertensive subjects.~   "
187371|NCT01111994|"~     The purpose of this study is ascertain the efficacy and safety of Clindamycin~      Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post~      Inflammatory Hyperpigmentation in patients with skin of color.~   "
187372|NCT01111981|"~     The purpose of this study is to ascertain the safety and efficacy of~      Clobetasol Propionate 0.05% E Foam in the treatment of Central Centrifugal~      Cicatricial Alopecia.~   "
187375|NCT01111942|"~     This is a non-randomized open-label investigator initiated pilot study comparing follow-up~     therapy of advanced head and neck cancer subjects initially treated with triple induction~     chemotherapy. Subjects will receive surgical treatment or combined chemoradiation therapy~     based on the subject's apparent clinical response. Spared use of radiation therapy for~     selective patients who have a complete response to induction chemotherapy could improve well~     being of this patient population without compromising survival.~   "
187376|NCT01111929|"~     Prolonged breast-feeding is an encouraged tradition in Egypt. Breastfeeding is associated~     with variable degrees of amenorrhea and infertility but there is a risk of resumption of~     fertility and therefore, of conception during lactation. A consensus statement formalized the~     lactational amenorrhea method of contraception (LAM), which has subsequently been included in~     the family planning programs in some developing countries. It has proved to be effective with~     cumulative pregnancy rates ranging from only 0.9% to 1.2%. However, if any of the~     prerequisites of LAM expire at any time, the contraceptive efficacy will be much reduced.~      The expiry of LAM requirements can occur unexpectedly at a time the woman is not ready to~     visit a clinic to initiate another contraceptive. Pregnancy during breast-feeding may result~     in mistimed, unplanned and sometimes unwanted childbirth. A study done in Egypt has shown~     that one in 4 of pregnancies during lactation were unplanned Such pregnancies, in addition to~     their negative social impact may lead some women to seek induced abortion; a procedure which,~     in settings (like Egypt) where abortion is illegal (except on very restricted grounds), is~     often unsafe.~      Levonorgestrel 1.5 mg EC pills has been used for long time and proved to decrease the~     incidence of pregnancy by 75-85% in each act of unprotected sexual intercourse. Its safety~     has been documented. It can be used safely during lactation and has been classified by the~     WHO medical eligibility criteria for contraception as category-1 for lactating mother. Even~     if take early in pregnancy it is not abortifacient and does not by any mean affect the~     continuation of pregnancy or cause any side effects to the growing baby (WHO category 1).~      The present study tries to estimate the efficacy of in advance provision of 1.5~     Levonorgestrel EC pills (as a back-up of LAM) at the time of counseling of LAM when used in~     increasing the incidence of initiation of another long term method of contraception and~     probably decreasing the incidence of unintended pregnancy during breast-feeding in rural~     Egypt.~      The investigators are planning to include all women who deliver in the investigators service~     and intent to breast-feed and planning of birth spacing. Women who refused to participate or~     planned to use a method of contraception other than LAM and those with expected difficulty of~     subsequent communication were excluded from participation.~      All eligible participants will receive proper counseling for LAM by trained research nurse.~      Women who choose to use LAM will be advised to return to the investigators contraception~     outpatient clinic to have a long term method of contraception as soon as any of the~     requirements of LAM expires. All eligible participants who accept to participate in the study~     will be randomly assigned to one of two groups:Group 1 will only receive the above described~     care (control group). Group II (Intervention group) in which women will have the above proper~     counseling. Additionally, they will be advised to use the EC pills if one of the~     prerequisites of LAM expires and sexual relation with their husband had occurred before the~     initiation of another contraceptive. Each women assigned to the intervention group will be~     supplied with one packet containing two 0.75 mg Levonorgestrel emergency contraceptive (EC)~     pills and advised to swallow the two tablets as soon as possible after having sexual~     intercourse with their husband after the expiry of LAM. They will be informed that they~     should not use the method after more than 5 days of having intercourse. They will be also~     advised not to use EC pills more than once. All women who have used the EC pills need to~     visit the clinic within few days of use for contraception advise. All the above information~     will be additionally given to the patient in a small flyer.~   "
187377|NCT01111916|"~     The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue~     elasticity parameters in the female pelvis.~   "
187378|NCT01111903|"~     Study in two stages, and with a sub-study.~   "
187379|NCT01111890|"~     Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is~     the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy~     variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort~     scale after first dose.~   "
187380|NCT01111877|"~     This study was conducted to describe the time to first incidence of otorrhea post~     tympanostomy tube insertion.~   "
187381|NCT01111864|"~     Infants and children under two years are the group with the highest rates of iron deficiency~     anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home~     iron fortification of complementary foods using micronutrient powders can be an effective~     approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient~     powders that contain the entire iron RDA for a child in a single dose in areas with high~     rates of infections from malaria and diarrheal disease. Therefore, in this study, we will~     investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of~     highly bioavailable iron, provided by a micronutrient powder added to a complementary food.~      The study aim is to determine if in-home fortification using an iron-containing micronutrient~     powder in Kenyan infants will improve iron status and/or modify the composition and metabolic~     activity of the gut microbiota. Active surveillance will be done weekly to monitor the health~     of the infants.~      Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding~     trial in which 330 infants will be randomized to receive a micronutrient powder containing~     either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only~     over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and~     after 6 months will be used to define the iron status and the anemia level of the infants.~     Stool samples (2 at baseline before intervention, 6 throughout the study and additional~     samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the~     entire study (n=330), we will measure changes in iron status over 1 year.~   "
187382|NCT01111851|"~     This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of~     participants treated with aprepitant is similar to that of participants treated with~     fosaprepitant at certain timepoints.~   "
187383|NCT01111838|"~     The purpose of this study is to find out what effects, good and/or bad STA-9090 has on~     colorectal cancer. This is a phase II trial which tests both how well the drug works in~     fighting your cancer as well as any possible side effects it will have on the patient.~      Cancer is a disease of uncontrolled growth. This growth is controlled in part by a series of~     proteins that are part of a growth pathway. Some of these proteins are destroyed by a protein~     called HSP90 and STA-9090 is a test drug which blocks one of the proteins that helps cancer~     grow. This study will also look at molecular markers that may affect how the cancer grows,~     and how it responds to treatment.~   "
187384|NCT01111825|"~     This is an open-label, single arm, multi-center, multi-national, adaptive design,~     dose-escalation Phase 1/2 study to determine the MTD of temsirolimus with daily neratinib,~     and to determine the safety and efficacy of this combination when given to patients with~     advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or~     triple-negative disease.~   "
187385|NCT01111812|"~     The 'Meir children's sport and health center' runs a multi-disciplinary intervention program~     for the treatment of overweight and obese children and adolescents. The program includes~     physical activity, dietary guidelines, medical supervision and behavioral treatment. The~     participants are routinely weighed once a week, at the same day and time, in order to~     supervise their progress. According to our experience, the child can predict his weight~     change, based on his behavior in the previous week. To our knowledge the overweight/obese~     child's ability to predict his weekly weight change, while participating in a~     multi-disciplinary intervention program, has never been tested.~   "
187386|NCT01111799|"~     It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of~     the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the~     rates of implantation and pregnancy. The hypothesis of our present study is that the~     endometrial injury procedure will have the same beneficial effect in patients undergoing~     controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).~   "
187387|NCT01111786|"~     Thirty subjects with systemic sclerosis and 30 age and sex matched controls without any known~     condition that should cause increased skin hardness in the fingers with undergo examination~     by manual palpation and durometer measured hardness of their digital tuft skin by 2 observers~     on 2 separate occasions. There will be 1 hour between individual observer's scorings.~     Observers will be blinded from the observer's scores and from their previous scores. Results~     will be tabulated and compared for manual scores versus durometer measurements,~     intra-observer scores by both methods and inter-observer scores by both methods.~   "
187388|NCT01111773|"~     The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg~     and tetracaine 70 mg topical patch for the treatment of pain associated with patellar~     tendinopathy.~   "
187389|NCT01111760|"~     The purpose of this study is to compare the radiation exposure of a variety of chest CT~     examinations performed on the current state of the art CT scanners (64 slice, dual source CT~     scanner) with the radiation exposure for identical chest CT examinations performed on the~     Siemens Flash CT scanner (high pitch dual source spiral technique).~   "
187437|NCT01111136|"~     Stress and chronic urticaria has been linked. The purpose of the study is to evaluate a~     patients chronic urticaria and stress levels before and after he/she goes through six~     sessions designed to help that participant manage his/her stress.~   "
187390|NCT01111747|"~     The central third of the patellar tendon is used as a donor site for anterior cruciate~     ligament (ACL) reconstruction. After months or years the harvest site partially regenerates.~     The regeneration process is accomplished by biological mechanisms,including cells and~     proteins known as growth factors. The platelets are natural reservoirs of growth factors, and~     a platelet concentrate known as Platelet-Rich Plasma (PRP) has a three to five fold increase~     in growth factors. The hypothesis of the study is that the PRP can improve the regeneration~     of the patellar tendon.~      The platelets are obtained from the patient's blood through a filtration system called~     apheresis, with the use of 250 milliliters of blood, with a sterile system. All the others~     components of blood (red cells, plasma, white cells) returns to the patient. The PRP is then~     applied in the harvest site on the patellar tendon, at the end of ACL reconstruction.~      The patients are randomized in two groups, one with the use of PRP and the other group~     without PRP. This information for the patients will be granted just at the end of the~     research. After the surgery the rehabilitation protocol is the same for both groups. An~     isokinetic testing is done before the surgery and after six months. Questionnaires about the~     knee function are asked before the surgery and after six months. A magnetic resonance imaging~     is performed after six months to evaluate the tendon regeneration.~   "
187391|NCT01111734|"~     Deliberate Self-Harm (DSH) among adolescents is a serious behavioral problem associated with~     significant injury, impaired functioning, reduced quality of life, and high rates of~     psychiatric hospitalizations. While DSH has not been shown to have a direct link to suicide~     attempts themselves, there is a clear link between individuals who engage in DSH and overall~     rates of suicide. There is currently no medication treatment approved by the FDA for the~     treatment of DSH.~      The goal of this study is to evaluate the efficacy and safety of the dietary supplement~     N-Acetylcysteine in adolescents aged 13-21 with deliberate self-harm behaviors. There will be~     an additional neuroimaging component to expand knowledge regarding the neural correlates of~     this treatment in the study population. We hypothesize that N-Acetylcysteine will reduce the~     severity of deliberate self harm behaviors because this supplement has been helpful in~     treating disorders that share some similar traits with DSH. We will be using this medication~     in 40 young people who deliberately harm themselves and we will assess the severity of their~     behaviors while being treated with this dietary supplement. We also will collect neuroimaging~     data on the study participants at baseline and after the treatment with N-Acetylcysteine and~     compare it to 40 age-matched healthy peer neuroimaging data. The purpose of including this~     healthy group is to expand knowledge about neural correlates of the study population prior to~     treatment.~   "
187392|NCT01111721|"~     Project POWER will test the efficacy of a multi-session HIV Prevention program, adapted from~     an existing program (Project SAFE), for incarcerated women in the rural South.~   "
187393|NCT01111708|"~     The purpose of this study is to investigate a new technique: Close Rectal Dissection (CRD) as~     restorative surgery for Ulcerative Colitis patients: the Close Rectal Ileo Pouch Anal~     Anastomosis (CR-IPAA). Clinical outcome and quality of life will be compared to the~     conventional Ileo Pouch Anal Anastomosis (C-IPAA) and the Ileo Neo Rectal Anastomosis (INRA).~   "
187394|NCT01111695|"~     In this open study, the primary objective is to study the efficacy and clinical outcome of~     the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be~     based on standardised photographs and clinical data.~      The secondary objectives are to evaluate the tolerance and side effects of the honey based~     preparation in the management of chronic wounds.~   "
187395|NCT01111682|"~     This study examines the role of osmotic agents in controlling brain swelling in brain injured~     individuals. Two osmotic agents -- mannitol and hypertonic saline -- are in common use, and~     they will be compared in the context of a randomized clinical trial. The goal is to determine~     if these agent differ in their ability to control episodes of brain swelling.~   "
187396|NCT01111669|"~     Functional endoscopic sinus surgery (FESS) is an effective treatment of sinus disease. FESS~     is carried out using cameras to view the surgical field. Bleeding during the surgery can lead~     to poor surgical field visualization. Poor visualization has been associated with worse~     surgical outcomes. Tranexamic acid is a safe and effective agent used to achieve hemostasis~     during operative procedures. The current study is a randomized controlled trial in patients~     undergoing FESS to compare the effects of tranexamic acid versus placebo and the effects on~     surgical field visualization and adverse events.~   "
187397|NCT01111656|"~     The SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study~     is the follow up study of the SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple~     Sclerosis (SWABIMS) (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS~     evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to~     interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with~     relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes~     patients that finish the SWABIMS study for another 12 month with ongoing unchanged~     medication.~   "
187398|NCT01111643|"~     To assess the utility of technician-based analysis of echocardiograms with longitudinal~     strain for ruling-in ischemic chest pain in the emergency room, compared to emergency room~     (ER) physician opinion and expert echocardiographer analysis of wall motion, both the latter~     blinded to any relevant clinical data .~   "
187399|NCT01111630|"~     The purpose of this study is to compare the hemoglobin and hematocrit variability between~     once and three times weekly erythropoietin therapy for the anemia in patients with~     maintenance dialysis.~   "
187400|NCT01111617|"~     The goal of this research program is to determine the potential effectiveness of real-time~     fMRI training in improving mental control over pain.~   "
187401|NCT01111604|"~     The purpose of this study is to determine if patients with metastatic colorectal cancer live~     longer without their cancer progressing when treated with standard chemotherapy, standard~     chemotherapy plus IMC-1121B, or standard chemotherapy plus IMC-18F1.~   "
187402|NCT01111591|"~     In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with~     COX2 inhibitor and assess survival rate and recurrent rate.~   "
187403|NCT01111578|"~     Investigators aim to evaluate the accuracy in the measurement of the esophageal and gastric~     pressure of a new enteral feeding tube~   "
187404|NCT01111565|"~     This will be a multicenter, randomized, double-blind study designed to assess the efficacy,~     safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in subjects~     with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram,~     and report a treatment history for the current MDD episode of an inadequate response to at~     least one and no more than three adequate trials of an approved antidepressant other than~     Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive~     symptom severity as assessed by the subject's self-report on the Massachusetts General~     Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the~     investigator as part of the subject's medical and psychiatric history. An adequate trial is~     defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for~     combination treatments) at an approved dose as specified in the ATRQ.~   "
187405|NCT01111552|"~     This will be a multicenter, randomized, double-blind study designed to assess the efficacy,~     safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in subjects~     with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram,~     and report a treatment history for the current MDD episode of an inadequate response to at~     least one and no more than three adequate trials of an approved antidepressant other than~     Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive~     symptom severity as assessed by the subject's self-report on the Massachusetts General~     Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the~     investigator as part of the subject's medical and psychiatric history. An adequate trial is~     defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for~     combination treatments) at an approved dose as specified in the ATRQ.~   "
187406|NCT01111539|"~     This will be a multicenter, randomized, double-blind study designed to assess the efficacy,~     safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in subjects~     with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram,~     and report a treatment history for the current MDD episode of an inadequate response to at~     least one and no more than three adequate trials of an approved antidepressant other than~     Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive~     symptom severity as assessed by the subject's self-report on the Massachusetts General~     Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the~     investigator as part of the subject's medical and psychiatric history. An adequate trial is~     defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for~     combination treatments) at an approved dose as specified in the ATRQ.~   "
187407|NCT01111526|"~     To test a new agent, LBH589, in combination with glucocorticoids as initial therapy of acute~     graft versus host disease (GVHD).~   "
187408|NCT01111513|"~     Total knee replacement is a frequent procedure in Québec's hospitals and the muscular~     strength of the quadriceps is the best indicator of the patient's functional recovery post~     surgery. Thus, the importance of the patient's recovery leads to the evaluation of the~     influence of the femoral nerve block on the muscle strength.~      The purpose of the study is to compare the short term and long term recuperation of the~     quadriceps' motor strength of after a total knee arthroplasty using different types of~     analgesics such as the continuous femoral nerve block, the single dose femoral nerve block~     and the systemic analgesic, a patient controlled analgesic pump.~   "
187409|NCT01111500|"~     Glenohumeral joint dislocation is the most frequent joint dislocation with a prevalence of~     1.7/100000 citizens/year. It is treated by reduction, under sedation or anaesthesia, followed~     by an immobilization of the arm.~      The purpose of the study is to evaluate the healing of the labrum in first time anterior~     glenohumeral joint dislocation with a Bankart lesion in young patients by comparing an~     external rotation brace to an internal rotation brace to immobilize the injured arm.~   "
187410|NCT01111487|"~     The objective is to evaluate whether the use of expiratory positive airway pressure (EPAP)~     reduces the electrical activity of the sternocleidomastoid muscle and enhances the action of~     the muscle in the patient parasternal ported from Chronic Obstructive Pulmonary Disease.~     Noting also, if the set pressure level (10 or 15 cmH2O) affects this relationship.~   "
187411|NCT01111474|"~     This study aimed to evaluate the effectiveness of two treatments for dental hypersensitivity:~     cyanoacrylate (Super Bonder®) compared with use of low intensity laser treatment. As the~     cyanoacrylate is a lower cost treatment, the hypothesis in investigation is if this product~     is equally effective as the laser treatment.~   "
187412|NCT01111461|"~     To assess the objective response rate (ORR: complete response + partial response [CR+ PR]) of~     E7080 in subjects with unresectable endometrial cancer and disease progression following~     platinum-based, first-line chemotherapy. .~   "
187413|NCT01111448|"~     The goal of this Pilot-study is to evaluate the response of unselected MDS patients to~     temsirolimus a drug approved for the treatment of renal cell cancer. It is planned to give~     temsirolimus at a weekly dose of 25 mg as intravenous infusion for a maximum duration of 12~     months. Regular bone marrow biopsies are planned for controlling MDS response.~   "
187414|NCT01111435|"~     This study is expected to contribute to the body of knowledge on the benefits of individuals~     with MS taking glatiramer acetate (Copaxone®). If patients have less spasticity when taking~     glatiramer acetate (Copaxone®), they may be more likely to have an improved quality of life.~      The hypotheses for this study are:~        1. Study participants who transition from interferon therapy to glatiramer acetate~          (Copaxone®) for a six month period will have a decrease in spasticity.~        2. Study participants who transition from interferon therapy to glatiramer acetate~          (Copaxone®) for a six month period will have a change in perceptions of the impact of~          spasticity on their lives.~   "
187415|NCT01111422|"~     Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal~     dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage~     during PD still remain unclear, generation of reactive oxygen species may be responsible for~     progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to~     protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the~     researchers investigated the hypothesis that NAC protect peritoneal membrane damage.~   "
187416|NCT01111409|"~     The primary objective of this pilot study is to evaluate the safety and effectiveness of the~     VFIX device in maintaining vaginal apical support for at least 6 months in women with~     symptomatic apical prolapse (upper vaginal or uterine prolapse).~   "
187417|NCT01111396|"~     There are two regions in the adult brain that exhibit neuronal stem and progenitor cells,~     generating new neurons postnatally and throughout adulthood. One is the so called~     subventricular zone the other is the dentate gyrus of the hippocampus. Adult neurogenesis is~     a physiological process representing an important functional impact for certain brain areas,~     especially the hippocampus. The hippocampal formation plays an important role in long-term~     memory and spatial navigation. Inhibition of adult neurogenesis in mice by chemotherapy or~     radiation is followed by significant deficits in hippocampal memory functions while~     hippocampus-independent memory is unaffected.~      Clinical trials had shown that chemotherapy and brain radiation lead to cognitive~     dysfunction. However, the exact mechanisms underlying this phenomenon are still unidentified.~      The aim of our study is to investigate, whether the inhibition of adult neural stem cell~     proliferation in the hippocampus by intrathecal chemotherapy and/or cerebral radiation is~     responsible for treatment induced memory deficits. We will investigate patients suffering~     from acute lymphatic leukaemia (ALL) that receive prophylactic intrathecal chemotherapy and~     brain irradiation. The study represents a longitudinal investigation including a virtual~     humanized version of the morris-water-maze to test hippocampus dependent spatial memory, as~     well as MR-imaging for morphological (volumetry) and biochemical (spectroscopy) data.~   "
187418|NCT01111383|"~     This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a~     positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if~     deemed appropriate by the Investigators will be able to be included in the 48-week follow-on~     period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser~     solution, 300 mg twice daily in 4 mL unit dose vials).~   "
187419|NCT01111370|"~     The purpose of this study is to evaluate the safety and effectiveness of the G4 System when~     worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin.~      Device performance will be primarily evaluated in terms of the proportion of G4 System values~     that are within ±20% of YSI reference value for glucose levels >80 mg/dL and ±20 mg/dL at~     meter glucose levels <80 mg/dL. These G4-YSI matched pairs will be collected during in-clinic~     sessions on Days 1, 4, and 7 of Sensor wear. The proportion of matched pairs from this study~     (PTL-900360) meeting the above criteria will be compared to the proportion of such points~     observed in the DexCom clinical study that supported approval of the SEVEN PLUS System (PTL~     300012).~      Safety data of the G4 System will also be collected and safety will be characterized by the~     incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse~     Device Effects experienced by study participants.~   "
187420|NCT01111357|"~     Rheumatoid arthritis (RA), affects between 0.3% and 1.0% of the population, it can lead to~     progressive joint destruction and severe disability. To date, two RA genetic susceptibility~     factors have been identified: HLA-DRB1-SE (Shared epitope) and PTPN22 620W alleles. The~     predictive value of the alleles for diagnosis of RA was previously investigated in cohorts of~     caucasians patients with early unclassified arthritis that showed restrained association~     between RA and HLA-SE. Despite the contribution of HLA to the overall genetic risk has been~     estimated to range from 30% to 50%, it has never been studied in the French west-Indian~     population.~   "
187421|NCT01111344|"~     The purpose of the study is to assess the efficacy of Glizigen and Viusid administration in~     the treatment of external anogenital warts in children and adolescents. The duration of this~     double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number~     of persons to be recruited and randomized for the study is 76. Variables to be assessed will~     be: time to disappearance of lesions, reduction of the number of lesions and change in the~     aspect of lesions.~   "
187422|NCT01111331|"~     The objective of the current study is to investigate the bioavailability of BI 10773 and of~     warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of~     warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the~     pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral~     administration of BI 10773.~   "
187423|NCT01111318|"~     The main objective of this study is to assess the effect of mild, moderate and severe hepatic~     impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral~     administration of BI 10773 as a single dose.~   "
187424|NCT01111305|"~     Diethylcarbamazine citrate (DEC) treatment of Loa loa infection is complicated by the~     development of severe adverse reactions that are correlated with the number of circulating~     microfilariae in the blood. The cause of these reactions is unknown, but they are accompanied~     by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of~     eosinophil activation. This randomized, placebo-controlled, double-blind pilot study~     (conducted at the NIH Clinical Center) will assess whether and to what extent the~     administration of reslizumab (Cinquil ), a humanized monoclonal antibody directed against~     IL-5, given 3 to 7 days before administration of the anthelminthic drug DEC (at 3 mg/kg 3~     times daily for 21 days), prevents the development of eosinophilia in 10 adult subjects with~     Loa loa infection and 0-5000 microfilariae/mL. Secondary outcomes will include the severity~     of post-treatment effects, markers of eosinophil activation, and effects of reslizumab on~     microfilarial clearance.~   "
187425|NCT01111292|"~     This pilot, randomized phase I/II trial studies how well inositol works in preventing~     colorectal cancer in patients with abnormal cells (dysplasia) associated with inflammation of~     the colon (colitis). Patients with colitis-associated dysplasia may have an increased risk of~     developing colorectal cancer. Inositol is a vitamin-like substance that may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
187426|NCT01111279|"~     The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered~     subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen~     allergic patients.~   "
187427|NCT01111266|"~     The purpose of this study is to determine the in-vivo ultrafiltration coefficient for~     different sizes of xevonta High-Flux dialyzers following FDA guidelines.~   "
187453|NCT01110928|"~     This study is conducted in Japan. The aim of this observational study is to collect~     information about the safety and efficacy of Norditropin® in the long-term treatment of~     patients with a SGA (small for gestational age) short stature where the growth plate in the~     long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial~     (NCT00184717).~   "
187428|NCT01111253|"~     Rationale~      The prevalence of colonic diverticular disease is increasing in Western countries.~     Approximately 10 to 25% of patients with diverticular disease will eventually develop an~     episode of acute diverticulitis. Currently conservative treatment often includes antibiotic~     therapy. This advice lacks sound evidence and is merely based on experts' opinion. An old~     clinical dogma is being clarified with this randomized trial.~      Objective~      Primary objective is to evaluate whether or not using antibiotics reduces to time to full~     recovery of an attack of uncomplicated (mild) diverticulitis. Secondary objectives are to~     evaluate complications, quality of life, readmission rate, recurrence rate, medical and~     non-medical costs, and antibiotic resistance/sensitivity in both groups.~      Hypothesis~      The investigators hypothesis is that in the treatment of uncomplicated (mild) acute~     diverticulitis, supportive treatment without antibiotics is a more cost-effective approach~     than conservative treatment with antibiotics with respect to time-to-recovery as primary~     outcome.~      Study design~      A randomized, open label, multicenter clinical trial comparing treatment of acute~     uncomplicated diverticulitis with antibiotics to observation and supportive care alone.~      Study population~      Patients 18 years or older are eligible for inclusion if they have a diagnosis of acute~     uncomplicated diverticulitis as demonstrated by imaging. Only patients with stages 1a and 1b~     according to Hinchey's classification or mild diverticulitis according to the Ambrosetti~     criteria are included.~      Intervention~      Conservative strategy with antibiotics: supportive measures and at least 48 hours of~     intravenous antibiotics (and therefore admittance to the hospital) and subsequently switch to~     oral antibiotics if tolerated (total duration of 10 days).~      Control~      Liberal strategy without antibiotics: supportive measures only. Observation and oral intake~     as tolerated. Admittance only if discharge criteria are not met on presentation.~      Main study parameters/endpoints~      The primary endpoint is time-to-recovery with a 6-month follow-up period. Secondary endpoints~     are occurrence of complicated diverticulitis requiring surgery or percutaneous treatment,~     morbidity, health related quality of life, readmission rate, recurrence rate, medical and~     non-medical costs, and antibiotic resistance/sensitivity.~   "
187429|NCT01111240|"~     This study is a documentation of effectiveness and safety of Humira in patients with~     psoriatic arthritis.~   "
187430|NCT01111227|"~     The aim of this study is to assess the profile of cytokines IL-1beta, IL-6, IL-8, IL-10,~     IL-12 and TNF-alpha under inhalation anesthesia with isoflurane and intravenous anesthesia~     with propofol in healthy patients subjected to minimally invasive elective surgeries.~   "
187431|NCT01111214|"~     Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal~     meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine~     (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar~     has been included in the Greek National Immunization Program.~      The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the~     occurring invasive pneumococcal disease, is an important factor to consider for the~     introduction of the 13-valent pneumococcal conjugate vaccine.~   "
187432|NCT01111201|"~     This study also aims to raise awareness among both patients and health-care providers about~     the importance of pre-travel health consultation and preventive interventions prior to~     international travel.~      Through appropriate health counseling, cancer patients will have less risk of having travel~     -related health complications and thus have a better quality of life and overall improved~     sense of wellbeing.~   "
187433|NCT01111188|"~     Mantle cell lymphoma (MCL) is characterized by cell cycle dysregulation. PD 0332991 is a~     cyclin-dependent kinase 4 and 6 inhibitor capable of inhibiting cell cycling of MCL. A phase~     I study has demonstrated the safety and anti-lymphoma activity of PD 0332991. Bortezomib is a~     first generation proteasome inhibitor approved for treatment of patients with recurrent MCL.~     Preclinical data suggests that PD 0332991 and bortezomib may act synergistically in MCL.~      PD 0332991 will be administered continuously for 12 days followed by a 9 day period without~     treatment. Bortezomib will be administered by intravenous bolus on days 8, 11, 15, and 18 of~     each cycle. One cycle is defined as three weeks. A maximum of ten cycles will be~     administered.~   "
187434|NCT01111175|"~     Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are~     scheduled for medically indicated surgical biopsy or resection of disease will be identified.~     Fresh/frozen tissue will be collected and will undergo comprehensive molecular evaluation~     with NextGen sequencing. TGEN's clonal genomics analyses will be applied in the analysis to~     identify and prioritize the mutated targets. Therapeutic options, based on the genetic~     profile of each patient's tumor, will be discussed and an appropriate molecularly-selected~     agent will be recommended by the Study Investigator(s) (SI) and treating oncologist as~     treatment for the patient.~      This is an open-label, pilot trial. Patients with metastatic or locally recurrent TNBC who~     are scheduled for medically indicated surgical biopsy or resection will be enrolled and~     therapeutic options, based on the genetic profile of each patient's tumor, will be discussed~     with the patient.~      Time-to-progression (TTP) for these patients following the selected therapy is the primary~     objective and will be compared to the TTP(s) for their most recent prior therapy. A 30%~     increase in TTP with the molecularly-targeted agent compared with the TTP on the immediate~     prior therapy will be considered as evidence of clinical benefit from the selected therapy.~     The secondary endpoints are best response to the molecularly-selected therapy, overall~     survival (OS) and genetic mutation evaluation in metastatic (or locally recurrent) TNBC.~      The study is designed to demonstrate that the collection and analysis of these tumor samples~     is feasible.~   "
187435|NCT01111162|"~     The overall goal of this study is to study influenza vaccine responses in HIV infected~     individuals. Immunocompromised individuals require special protection from influenza, but may~     not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu~     vaccine as part of their standard of care will be asked to donate blood samples for~     immunologic studies. These studies will determine whether participants were able to produce~     the appropriate antibodies to the vaccine and possibly identify predictors of vaccine~     responsiveness.~      Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be~     compromised in HIV infected patients.~   "
187436|NCT01111149|"~     There is a strong association between smoking and schizophrenia with prevalence rates ranging~     from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number~     of hypotheses have been proposed to explain the relationship between high smoking rates and~     schizophrenia, mostly relating to self-medication primarily for the negative symptoms of~     schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower~     than for other psychiatric disorders. The negative health effects of smoking increase the~     morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl~     in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not~     been any published studies of the efficacy of varenicline in schizophrenic subjects. As~     varenicline appears to be a promising treatment in non-psychiatric patients, it would be~     useful to expand these studies to examine its effects in schizophrenic patients. Identifying~     effective and safe means of smoking cessation for this vulnerable population has the~     potential to reduce morbidity and mortality among individuals with schizophrenia.~   "
187438|NCT01111123|"~     The purpose of this study is to determine whether the combinational use of ammonium lactate~     lotion 12% (Lac-Hydrin) and halobetasol propionate ointment 0.05% (Ultravate) is safe and~     effective in the initial treatment and long-term maintenance of psoriasis. Patients will use~     both medications continuously for two weeks and those who obtain a good improvement based on~     investigator clinical assessments will be randomized to Lac-Hydrin lotion twice daily every~     day with placebo ointment or Ultravate ointment twice daily on weekends only for up to 24~     more weeks.~   "
187439|NCT01111110|"~     Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve~     bronchodilator response during nocturnal bronchospasm.~   "
187440|NCT01111097|"~     The purpose of this study is to evaluate the safety and tolerability of oral Dichloroacetate~     (DCA) in the treatment of recurrent malignant brain tumors (RMBTs). RMBTs are defined as~     either: 1) malignant tumors, originating in the brain, that have recurred at least once or 2)~     malignant tumors originating elsewhere in the body that have spread to the brain at least~     once. Otherwise, there are no limitations to the number of prior recurrences. There are no~     limitations to the number or types of prior therapies.~   "
187441|NCT01111084|"~     This is a prospective and multicentric observational study to determine the real~     mono-bifollicular development rate that is obtained under normal care conditions following~     ovulation induction (OI) treatment with follitropin-alpha filled by mass prescribed in~     accordance with standard practice.~   "
187442|NCT01111071|"~     We seek to investigate whether hospitals in England and Wales vary in their rate of mortality~     following admission for heart attack or unstable angina, the extent of such variation,~     whether discharge diagnosis affects the extent of variation, and whether such variation has~     changed over time. Furthermore, we will investigate what individual- or hospital-level~     factors explain variation in mortality between hospitals.~   "
187443|NCT01111058|"~     Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects~     treated with everolimus versus placebo after definitive local therapy.~   "
187444|NCT01111045|"~     The objectives of the study are to evaluate the safety and efficacy of intraarticular BMP-7~     for the treatment of osteoarthritis of the knee.~   "
187445|NCT01111032|"~     During this study the investigators will compare the use of two treadmill tests in people~     diagnosed with cancer. The STEEP treadmill protocol is often used to evaluate the endurance~     of people diagnosed with cancer, however, since it is based on step increases in speed or~     ramp, it may not related to normal function. The new test, which is based on the body~     response to increased activity has not been used with people with cancer but may provide a~     better approximation of endurance demands during daily function. Our question is whether the~     new treadmill test can be used to evaluate aerobic function with people with cancer better~     than the STEEP treadmill test.~   "
187446|NCT01111019|"~     This study is conducted to describe the efficacy and safety of recombinant human growth~     hormone (r-hGH) treatment Saizen® on children with hypochondroplasia.~   "
187447|NCT01111006|"~     The purpose of this study was to evaluate the effect of Bidet on anal resting pressure with~     regards to various flow rates and temperatures.~   "
187448|NCT01110993|"~     This is a prospective, non-interventional, multicenter study to evaluate quality of life~     (QoL) and influence of cognitive status on QoL in subjects with relapsing-remitting multiple~     sclerosis (RRMS) during two years of treatment with Rebif New Formulation (RNF).~   "
187449|NCT01110980|"~     -  Background:~      Oral nutrition appears to be a challenge for patients with head and neck cancer after~     radiotherapy. Many patients desire to (their) `normal food intake` and return to oral~     nutrition with normal consistency without modifications and diet formulas. Due to the~     dysphagia experienced post treatment this seems tremendously difficult. Referral to a~     speech-language therapist for swallowing therapy is no standard procedure.~        -  Study design:~      A prospective randomized study in patients with a tumor in Oral cavity, Nasopharynx,~     Oropharynx, Hypopharynx or Larynx with stage II-IV (UICC TNM-tumor classification), ≥ 18~     years, eligible for primary treatment with (chemo)radiation or adjuvant radiotherapy with~     curative intent.~        -  Intervention:~      Individually tailored swallowing therapy by an experienced speech-language therapist in~     cooperation with individual dietary counselling (by an experienced dietician, `usual care`)~     pre-, per- and post treatment (until 6 months after treatment). This might improve `normalcy~     of food intake`, quality (no food modifications) and quantity of food intake and besides~     decrease the use of tube feeding and/or nutritional supplements. Also patients quality of~     life and nutritional status may be influenced positively.~        -  Study hypothesis:~      The purpose of this study is to determine whether combined individual swallowing therapy and~     individual dietary counselling in patients with head and neck cancer receiving~     (chemo)radiotherapy can improve 'normal food intake'. Food intake without modifications and~     tube feeding and/or nutritional supplements.~   "
187450|NCT01110967|"~     The Satellite™ Retrospective Analysis is an international, retrospective, multi-center,~     non-interventional post-marketing study designed to document and analyze existing data with~     the device in a real-world setting.~      The purpose of this study is to evaluate number of adverse device effects (ADEs), serious~     adverse device effects (SADEs) and serious adverse event (SAEs) and early clinical~     effectiveness for the Satellite™ Nucleus Replacement in a standard clinical practice. Data~     collection will include information on health related quality of life (QoL), physical~     functioning and adverse event after nucleus replacement surgery. Radiographic measures will~     also be assessed to evaluate changes in disc height at the operated level and changes in~     segmental range of motion.~      All patients who were implanted with a Satellite™ Nucleus Replacement Prosthesis in the~     participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.~   "
187451|NCT01110954|"~     This is an explorative phase II study to investigate the suitability of PD L 506 in the~     specific intra-operative detection of breast tumour tissue.~   "
187452|NCT01110941|"~     S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal~     cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more~     encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the~     SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.~   "
187469|NCT01110720|"~     The purpose of the study is to evaluate the safety and efficacy of davunetide for the~     treatment of Progressive Supranuclear Palsy.~   "
187454|NCT01110915|"~     The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in~     the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up~     to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur~     anywhere on the body including the chest).~   "
187455|NCT01110902|"~     The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of~     sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive~     Disorder. This study includes an 8-week double-blind phase.~   "
187456|NCT01110889|"~     The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of~     sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive~     Disorder. This study includes an 8-week double-blind phase.~   "
187457|NCT01110876|"~     Phase I Objectives:~      -To determine the maximum tolerated dose (MTD) of vorinostat + erlotinib versus vorinostat +~     erlotinib + temozolomide in adult patients with recurrent glioblastoma multiforme (GBM) and~     anaplastic gliomas.~      Phase II Objectives:~      Primary: To determine the efficacy of vorinostat + erlotinib versus vorinostat + erlotinib +~     temozolomide in patients with recurrent glioblastoma multiforme as progression free survival~     using a two arm adaptive randomization phase II trial design.~      Secondary: To determine the radiological response, progression free survival (PFS) at 6~     months, overall survival and unexpected toxicity in the two treatment arms; and to obtain~     exploratory data regarding histone 3 and 4 acetylation, treatment related changes in the~     epidermal growth factor receptor (EGFR) pathway proteins, and changes in e-cadherin and~     vimentin expression (mRNA /protein) levels in tumor tissue and peripheral monocytes in a~     subset of surgical patients.~   "
187458|NCT01110863|"~     By ingesting a non-radioactive and non-toxic compound heavy water for 6 weeks, the DNA of~     newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia can be~     labeled and followed by performing routine blood draws at specified time intervals. By using~     mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the~     bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help~     us to better understand the unique characteristics of this disease process.~   "
187459|NCT01110850|"~     Chronic lymphocytic leukemia. B-cell chronic lymphocytic leukemia (B-CLL) is the most~     prevalent leukemia in the Western Hemisphere, accounting for ~25% of all leukemia's. It~     represents a monoclonal expansion of small, long-lived, apparently slowly dividing CD5+ B~     cells. Because of the low proliferative index and a presumed uniform proliferative rate of~     B-CLL cells in vivo (a fact not yet tested or documented), B-CLL appears to be primarily a~     disease of accumulation rather than proliferation.~   "
187460|NCT01110837|"~     What happens in the nose during an allergic reaction? Are there changes that a new drug could~     treat? What is the best way to test new drugs?The response of the nose to being exposed to~     cat allergen in someone who is allergic to cats. Symptoms, level of nasal blockage and cell~     and chemical changes that occur in the nose will be studied before and after being exposed to~     cat allergen. The investigators will also to see if giving repeated doses of allergen~     increases the response.Allergic rhinitis is a very common illness. There are over 500 million~     patients worldwide. It can increase the severity of associated asthma. Currently available~     drugs do not completely treat the symptoms. New treatments need to be found. A way of testing~     these drugs is very important. This study will investigate causes of the symptoms that occur~     in allergic rhinitis. It will also validate a proposed model to test new drugs. the Study~     Hypothesis is that a model of nasal allergen challenge shows an increased response (priming)~     with repeat challenges as determined by changes in nasal peak inspiratory flow.~   "
187461|NCT01110824|"~     The investigators' objective is to assess the efficacy of the combined treatment with~     enalapril and carvedilol in the prevention of left ventricular systolic dysfunction in~     patients with hematological malignancies submitted to intensive chemotherapy with potential~     cardiotoxicity.~      The hypothesis is that these drugs administered during chemotherapy may prevent left~     ventricular systolic dysfunction.~   "
187462|NCT01110811|"~     The study objective is to evaluate the relative merits, safety and effectiveness of transoral~     incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients~     compared with sham procedure.~   "
187463|NCT01110798|"~     RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective~     than a straight colorectal anastomosis in treating patients with rectal cancer who have~     undergone surgery to remove the tumor.~      PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how~     well it works compared with straight colorectal anastomosis in treating patients with rectal~     cancer who have undergone surgery to remove the tumor.~   "
187464|NCT01110785|"~     RATIONALE: Simvastatin may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Giving simvastatin~     together with panitumumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well simvastatin given together with panitumumab~     works in treating patients with advanced or metastatic colorectal cancer.~   "
187465|NCT01110772|"~     The purpose if this study is to determine whether a microbial sealant (iodine +~     cyanoacrylate) [InteguSEAL®, Kimberly-Clark] reduces surgical site infections when compared~     to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) [Duraprep®] in oncologic~     surgery.~   "
187466|NCT01110759|"~     In this study, the effects of local block vs non block will be assessed with respect to~     postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand~     surgery.~   "
187467|NCT01110746|"~     The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and~     Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.~   "
187468|NCT01110733|"~     The COMPLETE registry is a prospective, longitudinal, multinational, observational study that~     will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in~     academic and community practices. The registry will enroll newly-diagnosed patients with PTCL~     treated with a variety of regimens. The COMPLETE registry is designed to better understand~     PTCL patient characteristics, treatments, and outcomes to help design and understand future~     clinical trials.~   "
187470|NCT01110707|"~     This was a prospective, randomized, Phase II, comparative study with a parallel control for~     evaluating the efficacy and safety of combined treatment of recombinant human follicle~     stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined~     treatment was administered at the middle of the follicular phase in subjects undergoing~     in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of~     embryos (ET).~   "
187471|NCT01110694|"~     Idiopathic pulmonary fibrosis (IPF) is a progressive scarring condition of the lungs the~     cause of which is unknown.There are currently no effective treatments for IPF and the~     condition tends to cause progressive disability and death with an average survival of 3.5~     years from diagnosis. The condition is responsible for the deaths of 4000 people per year in~     the UK. At present the definite diagnosis of IPF rests on the identification of a specific~     pattern of fibrosis when a section of fibrotic lung tissue is examined under a microscope.~     Unfortunately, the process of obtaining a lung biopsy requires an operation and is not with~     out risk. The investigators hope to identify specific markers in the blood and lungs of~     patients with IPF that will enable the condition to be diagnosed without biopsy. Furthermore,~     the investigators hope to identify indicators(biomarkers) that will predict which patients~     have more aggressive and progressive disease and also to identify biomarkers that might be~     useful in identifying a response to treatment and might therefore be used in future clinical~     trials in IPF. As well as looking at markers in the blood and lungs the investigators also~     plan to assess the use of daily home lung function measurement and a computerised technique~     for analyzing lung sounds to see if these are investigations that are able to predict the~     development of worsening lung fibrosis.~   "
187472|NCT01110681|"~     The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in~     the treatment of fecal incontinence for a total of 24 months after completed treatment.~   "
187473|NCT01110668|"~     This study will assess time-to-disease progression in patients with advanced gastrointestinal~     stromal tumor (GIST) previously treated with imatinib ≥600 mg.~   "
187474|NCT01110655|"~     The purpose of the study is to 1) evaluate incidence and primary cause of exercise-associated~     Hyponatremia (EAH) in race finishers participating in the Western States 100-mile Endurance~     Run, 2) determine if the ingestion of oral hypertonic saline (high salt) is as effective as~     intravenous administration of hypertonic saline to elevate below-normal blood salt~     concentrations (EAH) at the end of the Western States Endurance Run, and 3) determine if oral~     and intravenous hypertonic saline solutions are equally as effective at reversing mild~     (without altered mental status) symptoms associated with EAH.~   "
187475|NCT01110642|"~     This is an open label-pilot study to assess the efficacy and safety of a novel~     cholesterol-lovastatin topical solution in children with rare syndromic ichthyoses. Often~     times, these children have difficulty in finding easily applied treatments to make their~     psoriasiform and ichthyotic plaques more manageable. We propose the use of a~     cholesterol-lovastatin topical solution as a treatment option with the hypothesis that it~     will lead to regression of involved areas and decreased erythema and warty-like appearance of~     the plaques. We plan to enroll children with syndromic ichthyoses over the age of 1 year for~     a 12 month study with a total of 5 visits and 5 phone calls.~   "
187476|NCT01110629|"~     The objective of this study is to investigate the efficacy and safety of lanthanum carbonate~     750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.~   "
187477|NCT01110616|"~     The objective of this study is to test the experimental reproducibility and within-subject~     variability of qEEG (quantitative electroencephalogram) using two probe compounds: MK3134 and~     lorazepam.~      This study will test the hypothesis that EEG (Electroencephalogram) theta power, averaged~     across a topographical region of interest is decreased 6 hours after administration of MK3134~     compared to placebo.~      The objective of this study is to test the experimental reproducibility and within-subject~     variability of qEEG using two probe compounds: MK3134 and lorazepam.~   "
187478|NCT01110603|"~     This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and~     recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard~     doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the~     treatment of advanced solid cancers in adults.~   "
187479|NCT01110590|"~     Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this~     multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552~     and vardenafil will be given with patients with erectile dysfunction.~   "
187480|NCT01110577|"~     This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction~     measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC)~     for the repeated measurements is expected to be greater than 0.6.~   "
187481|NCT01110564|"~     The primary objective of this non-interventional study is to evaluate daily symptom~     variability in COPD patients. The secondary objectives are; to evaluate effects of COPD~     symptoms on the morning activities of patients, to determine therapeutic expectations of~     patients and physicians in COPD, to determine which and how frequent non-drug approaches are~     recommended in order to prevent COPD exacerbations, to define COPD patient profiles about the~     below-mentioned issues: Demographic characteristics, Disease characteristics, Concomitant~     diseases and implemented drug treatments. All patients, who apply to the study physicians and~     fulfill all patient selection criteria during patient enrolment period, will be included.~     Patients, who provide all of the following measures will be included in the study: To apply~     to a physician for outpatient treatment for any reason, Age over 45 years, being diagnosed~     with COPD, being a smoker or used to be a smoker once (> 10 package years), to give consent~     for the use of their medical data. The patients that exhibit the following exclusion criteria~     will be excluded from the study: COPD exacerbations still on-going or experienced in the last~     3 months (Exacerbation is defined as worsening of COPD symptoms leading to antibiotic and/or~     short-term oral steroid treatment and/or hospitalization or admission to the emergency~     unit.); Presence of lung cancer or an important respiratory disease such as bronchiectasis,~     pulmonary fibrosis, interstitial pulmonary disease, tuberculosis, sarcoidosis; Participation~     in an interventional clinical trial at present and Enrollment in this study once. In this~     study, patients will be recorded at their visit to the physician and there will be no~     follow-up thereafter.~   "
187482|NCT01110551|"~     The purpose of this study is to test the safety and immune response to a live attenuated~     dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated~     means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated~     (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by~     mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of~     18-45 years old will be enrolled in this research study at Saint Louis University Center for~     Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2~     doses of the study vaccine or placebo (inactive substance). Study procedures include:~     maintaining a diary to record temperature and side effects, physical exam, electrocardiogram~     (ECG) (measures the activity of the heart), and blood samples. Participants will be involved~     in study related procedures for about 10 months.~   "
187483|NCT01110538|"~     Information will be collected prospectively in about 3,000 patients having Optical Coherence~     Tomography during cardiac catheterization. Subjects will be initially enrolled at sites~     outside of the United States, where Optical Coherence Tomography is approved by regulatory~     agencies. Subjects will be followed for up to 5 years.~   "
187484|NCT01110525|"~     The primary purpose of this study is to determine whether the treatment with AZD1981 will~     affect the metabolism of hormones included in oral contraceptives.~   "
187485|NCT01110512|"~     It is hoped that with the use of medication, occurs improvement of the CVI parameters, such~     as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is~     non-inferior than the comparator.~   "
187486|NCT01110499|"~     This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of~     AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in~     the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a~     formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost~     ophthalmic solution 0.03% for 4 weeks.~   "
187487|NCT01110486|"~     The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated~     dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel.~   "
187488|NCT01110473|"~     The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated~     dose of ABT-348 as monotherapy and when given in combination with azacitidine.~   "
187489|NCT01110460|"~     Accordingly, the new update of the Global Initiative for Asthma (GINA) guidelines 2006 is~     based on the control of the disease and attempts to quantify and graduate the level of~     control by using a classification of asthmatic subjects into controlled,partly controlled and~     uncontrolled groups.~      Achieving and maintaining optimal asthma control is a major goal of asthma management.~     Although the results of clinical trials advocate that asthma control can be reached in most~     patients, there is evidence that many subjects with asthma have poorly controlled disease and~     that there is a significant gap between the treatment goals and the current level of asthma~     control achieved in the general population.~      The aim of this study is to assess the prevalence of uncontrolled and partly controlled~     asthma in Italy using a patient-based tool such as Asthma Control Test.~   "
187490|NCT01110447|"~     The aim of the proposed project is to study the effects of a probiotic preparation (VSL#3®)~     for the prevention of recurrence of HE (Hepatic encephalopathy) in patients after the~     recovery of an episode of overt HE (secondary prophylaxis)~   "
187491|NCT01110434|"~     Cannabis use is a significant public health concern that disproportionately affect youth.~     Although promising psychosocial interventions are being developed, most youth do not benefit~     from these interventions alone. Given the clinical demand for effective treatments, the~     National Institute on Drug Abuse (NIDA) identified the critical need for data on the~     tolerability and potential efficacy of medications in adolescents. The purpose of this~     two-year study is to test if and how topiramate, a medication under intense study for~     treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the~     investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years~     old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for~     the 6-week period using handheld electronic diaries and complete assessments of reactivity to~     cannabis-related cues.~   "
187492|NCT01110421|"~     The purpose of this study is to evaluate the safety and tolerability of doripenem compared to~     cefepime in children hospitalized with pneumonia.~   "
187493|NCT01110408|"~     The purpose of this study is to evaluate the safety and tolerability of doripenem compared to~     cefepime in children hospitalized with complicated urinary tract infections.~   "
187494|NCT01110395|"~     Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance~     spectroscopy allows us to measure energy produced in the heart. The purpose of this study is~     to determine if the energy production is reduced in failing heart.~   "
187495|NCT01110382|"~     The purpose of the study is to evaluate the safety and tolerability of doripenem compared~     with meropenem in children hospitalized with complicated intra-abdominal infections.~   "
187496|NCT01110369|"~     The present study is designed to investigate whether timed protein supplementation will~     increase skeletal muscle mass in the frail elderly population.~   "
187497|NCT01110356|"~     research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be~     due to iron deficiency.~   "
187498|NCT01110343|"~     This application compares the effectiveness of a conventional Parent Group intervention to~     Mindfulness- Based Stress Reduction (MBSR) in parents of children with autism spectrum~     disorders (ASD) and other disabilities. Parent groups are widely-used to provide information,~     emotional support, education and advocacy. MBSR is efficacious for people with medical,~     psychiatric or other concerns, and teaches stress reduction through mindfulness training and~     practice. In contrast to conventional parent groups, the investigators' studies suggest that~     mindfulness-based interventions may be particularly effective in reducing stress and~     improving the health and mental health of parents of children with disabilities. The~     investigators will assess parent factors that may correlate with intervention efficacy in the~     2 treatment arms.~   "
187499|NCT01110330|"~     The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as~     effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo~     in treating patients with Tinea pedis, a skin infection commonly known as athlete's foot~     that is caused by a kind of mold called a fungus.~   "
187501|NCT01110304|"~     Acromio-clavicular (AC) joint dislocation corresponds to 8.6% of all joint dislocations and~     represents a major injury to the shoulder girdle. The nature of the treatment is decided~     according to the severity of the lesion.~      The purpose of this study is to determine whether the surgical treatment is required or not~     for type III AC joint dislocations.~   "
187502|NCT01110291|"~     Twenty patients with verified high risk breast cancer will be included in the study. Patients~     will receive three cycles of docetaxel followed by three cycles of CEF for their adjuvant~     treatment. The phenotype of CYP3A and the genotype of CYP3A5 and MDR1 will be assessed. Also~     the effect of docetaxel in the activity of CYP3A will be measured by peroral midazolam.~      Primary Object:~      The primary object of this study is to define, if it is possible to predict the clearance~     and/ or toxicity of docetaxel by assessing~        -  activity of CYP3A4 by midazolam test (CYP3A4 phenotype)~        -  CYP3A5 genotype~        -  MDR1 genotype~      Secondary object:~      The secondary object of this study is to define whether the treatment with docetaxel alters~     the activity of CYP3A4 enzyme in previously untreated breast cancer patients.~   "
187503|NCT01110278|"~     Urgency incontinence (where the bladder muscles contract suddenly, causing an immediate urge~     to urinate that is difficult to prevent) is commonly experienced in patients with overactive~     bladder. New findings have discovered that urgency incontinence may be connected to the~     interactions of certain regions of the brain and the bladder. Although this is a common~     problem, researchers still do not know how these interactions impact the process of urgency~     incontinence. The purpose of this study is to better understand how the brain functions, by~     using Magnetic Resonance Imaging (MRI) machine and Diffusion Tensor Imaging (DTI) to create~     images of the brain during different bladder states.~   "
187504|NCT01110265|"~     Research has consistently found attentional biases towards negative weight-related stimuli in~     individuals with eating disorders. It has been suggested that these biases may act as a~     vulnerability factor for the development and maintenance of body dissatisfaction and may~     therefore be an important target for intervention. Previous studies have demonstrated the~     capacity to modify the patterns of attention allocation to threatening stimuli in a variety~     of anxiety disorders, with a subsequent and sustained reduction in anxiety symptoms. Thus,~     the present study aimed at testing the efficacy of attention training in reducing attentional~     biases and eating disorder symptoms in individuals with elevated levels of body image~     disturbance and eating disorder symptomatology of clinical severity. Thirty-two participants~     were randomly allocated to receive eight sessions of a 10-minute computer task aimed at~     training their attention away from weight-related stimuli or a control placebo training~     condition. Results showed that participants in the attention training group had a~     significantly greater reduction in their attentional bias and body dissatisfaction from pre-~     to post-training relative to the placebo condition. At follow-up, both groups showed a~     significant decrease in body dissatisfaction from their pre-training levels. The only~     significant difference between groups in eating disorder symptoms at follow-up was in terms~     of the attention training group experiencing a greater reduction in weight and shape~     concerns.~   "
187505|NCT01110252|"~     The purpose of this study is to determine whether the cell therapy with bone marrow~     mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease,~     specifically the pulmonary emphysema.~   "
187506|NCT01110239|"~     In remote preconditioning, ischemia in one organ protects distant organs from ischemic~     insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe~     stroke.~      The objective of this study is to determine if remote ischemic preconditioning can be safely~     and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for~     developing disabling cerebral ischemia. The investigators will also preliminarily assess if~     there is evidence for neuroprotection. This will be a Phase 1b study.~      Additional objectives are:~        1. to determine if remote ischemic preconditioning can be safely and effectively instituted~          in patients with subarachnoid hemorrhage, who are at high risk for developing disabling~          cerebral ischemia.~        2. analogously to a dose-escalation study the investigators propose to study the safety and~          tolerability of increasing durations of limb ischemia until a target time of 10 minutes~          of limb ischemia has been reached.~   "
187507|NCT01110226|"~     This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of~     investigational drugs that can be safely delivered and to define the side effects that limit~     the dose. The drug administered in this study is KML-001. It is a highly soluble, orally~     available arsenic agent. It is currently being tested to determine its effects on telomerase~     activity.~      In other words, the purpose of this research study is to find the highest dose of KML001,~     that can be given without causing severe side effects when it is combined with a standard,~     commercially available anti-cancer drug called cisplatin.~   "
187508|NCT01110213|"~     The primary aim of this feasibility study is to determine if a theory-based lifestyle~     intervention consisting of telephone counseling is associated with improvements in physical~     activity and dietary intake.~   "
187509|NCT01110200|"~     This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted~     in the United States. The purpose of the study is to evaluate the rate of exacerbations of~     chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute~     exacerbation of COPD, in patients receiving either fluticasone propionate/salmeterol~     combination product 250/50mcg BID or salmeterol 50mcg BID via DISKUS™ over 29 weeks. The~     study population will include patients hospitalized for an acute exacerbation of COPD. The~     target enrolment is 720 subjects at 80 study centers. The primary endpoint is the rate of~     exacerbation requiring hospitalization that occur more than 21 days post-discharge, emergency~     room visit or physician's office visit for an exacerbation of COPD requiring treatment with~     oral corticosteroids or oral corticosteroids and antibiotics. The secondary endpoint is the~     rate of COPD exacerbation requiring treatment with oral corticosteroids, antibiotics, and/or~     hospitalization (alone and in combination). Related efficacy endpoints include, time to first~     exacerbation of COPD requiring treatment with oral corticosteroids, antibiotics, and/or~     hospitalization (alone and in combination), pre-dose AM FEV1, the probability of premature~     withdrawal of subject from the study, and supplemental albuterol use, change in biomarkers of~     inflammation, including, surfactant protein D (SP-D), clara cell secretory protein 16 (CC-16)~     and high sensitivity C-reactive protein (hs-CRP). Health outcome assessments include domain~     scores evaluation for fatigue, dyspnea, emotional function and mastery, measured with the~     Chronic Respiratory Disease Questionnaire self-administered standardized format (CRQ-SAS);~     and symptoms (congestion, cough, phlegm, mucus, chest discomfort, shortness of breath and~     sleep disturbance), assessed by the EXAcerbations of Chronic pulmonary disease Tool (EXACT).~     Albuterol will be supplied to study subjects for use as-needed throughout the study. Safety~     will be assessed by monitoring of adverse events.~   "
188349|NCT01099176|"~     The study is planned to show whether monotherapies or combined hypolipemic therapy influence~     the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and~     proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.~   "
187510|NCT01110187|"~     Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental~     status changes due to severe traumatic brain injury (sTBI) will result in improved short- and~     long-term outcomes and better immediate adverse effects when compared to the current standard~     of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing~     clinical and sub-clinical seizure activity.~   "
187511|NCT01110174|"~     A pilot study of adult (≥ 18 years) women with stage II-III breast cancer who will receive~     preoperative chemotherapy prior to mastectomy. Patients will have real-time serum glycan~     profiling, expression of tissue MUC 1 oncoprotein isoforms to predict neoadjuvant~     chemotherapy response and additional mammography and HD PET/CT examinations to assess~     response. The investigators hypothesize that a functional tumor assessment utilizing~     high-definition positron emission tomography/computed tomography (HD PET/CT), real-time serum~     glycan profiling, and expression of tissue MUC 1 oncoprotein isoforms will predict~     neoadjuvant chemotherapy response in breast cancer patients.~   "
187512|NCT01110161|"~     The goal of this project is to compare visceral fat measurements derived from Lunar iDXA~     total body scans and from Computed Tomography (CT) scans of the abdominal region for a~     Chinese population.~   "
187513|NCT01110148|"~     The investigators investigated the use of portable MP3 technology in patient education and~     informed consent of shave and punch biopsies. Eighty patients were divided randomly into a~     control and experimental group. Control patients received the standard of care in patient~     education and informed consent. Experimental patients watched a short 80-second video on~     shave or punch biopsies. All patients were given pre- and post-education questionnaires to~     assess the efficacy of each method.~   "
187514|NCT01110135|"~     This phase II trial is studying how well giving bendamustine hydrochloride, etoposide,~     dexamethasone, and filgrastim together for peripheral stem cell mobilization works in~     treating patients with refractory or recurrent lymphoma or multiple myeloma. Giving~     chemotherapy, such as bendamustine hydrochloride, etoposide, and dexamethasone, before a~     peripheral stem cell transplant stops the growth of cancer cells by stopping them from~     dividing or killing them. Giving colony-stimulating factors, such as filgrastim, and certain~     chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be~     collected and stored~   "
187515|NCT01110122|"~     Rationale: During exercise protein breakdown in muscles is larger than protein synthesis.~     This negative muscle protein balance leads to increased muscle damage and thereby to a~     reduced muscle tissue recovery. To achieve a positive muscle protein balance and reduce~     muscle damage, many athletes use proteins. In professional soccer players, considerable~     stress is placed on the musculoskeletal system. Recovery time is often too short for these~     players to restore homeostasis, which results in catabolic processes. This increases playing~     errors and will lead to lapses in concentration. Therefore, it is of great importance for a~     professional soccer team to be in optimal condition and a fast recovery after exercise is~     desirable to accomplish maximum performance. Supplementation with whey proteins is thought to~     support this.~      Objective: To assess whether post-exercise supplementation with whey protein will lead to a~     better muscle recovery than supplementation with carbohydrates in Dutch soccer players~     between the age of 15 and 18 years old.~      Study design: A double blind randomised controlled cross-over trial.~      Study population: Healthy soccer players of the A and B selection of AJAX between the age of~     15 and 18 years old.~      Intervention: Supplement, containing either whey proteins or an isocaloric carbohydrate~     placebo. Each supplement will be administered for 2 weeks separated by a 7 day washout~     period. Treatment order will be randomly assigned.~      Main study parameters: The main study parameter will be the Yo-Yo intermittent recovery test~     level 2 score and the vertical jump test. The scores will evaluate the soccer players'~     ability to repeatedly perform intense exercise and his potential to recover from this~     exercise.~   "
187516|NCT01110109|"~     In this study, subjects meeting criteria will be enrolled and randomized to one of two~     different suctioning schemes, either continuous or intermittent. Accumulated secretions will~     be collected above the cuff on the breathing tube by one of the two methods depending on~     which group the subject is randomized into. Secretions will continue to be collected at~     predetermined periods of time for the duration of surgery in order to characterize the pH and~     volume as well as the micro-organism content.~   "
187517|NCT01110096|"~     The study compares the effect on BMI of two different treatment options for obesity in~     childhood. Families with at least one obese child and parent are invited to join the project.~     The hypothesis is that family camp gives an additional reduction in BMI compared to a less~     intensive family lifestyle school.~   "
187518|NCT01110083|"~     EMD Serono has closed enrollment into this trial prior to determination of maximum tolerated~     dose (MTD). EMD Serono has decided not to pursue the development of EMD 1204831 in patients~     with advanced solid tumors for reasons other than safety.~   "
187519|NCT01110070|"~     The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in~     the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6~     months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System~     may give symptomatic relief of pain and help to restore knee function. Included in this study~     is pain relief using Visual Analog Scale (VAS), knee function using the International Knee~     Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36~     (SF-36) survey.~   "
187520|NCT01110057|"~     This study will be a double-blind, placebo-controlled, parallel group study. After enrolment~     and initial assessments, subjects will receive 35 days of study medication. During this~     treatment period, they will be randomised to either oral GW856553 7.5mg BID or matching~     placebo in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 128~     evaluable subjects.~   "
187521|NCT01110044|"~     The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK~     Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by~     routine paediatric vaccination.~   "
187576|NCT01109329|"~     Human metapneumovirus (HMPV) is a virus that can cause respiratory illness. In older adults,~     those with asthma, infants, and children, illness can be severe, but in healthy adults the~     virus frequently causes no symptoms. The National Institute of Allergy and Infectious~     Diseases (NIAID) is working to develop a vaccine for HMPV that could be given to infants.~     Before potential vaccines can be tested, information about how HMPV affects healthy adults is~     needed. This study will examine the effects of exposure to HMPV in healthy adults.~   "
187522|NCT01110031|"~     Ofatumumab is a fully-human monoclonal antibody that exhibits high binding affinity to an~     antigen on the surface of B lymphocytes. Antigen engagement by ofatumumab results in maximal~     B-cell killing through complement-dependent cytotoxicity and antigen-dependent cellular~     cytotoxicity in both antigen high- and low-expressing cells. Recent research has shown that~     ofatumumab-dependent B-cell depletion provides clinical benefit to subjects with~     CD20-positive cancers such as chronic lymphocytic leukemia (CLL). The purpose of the current~     study is to assess the impact of ofatumumab on electrocardiographic parameters with~     particular focus on cardiac repolarization (QTc interval duration) in subjects with~     refractory CLL. Subjects enrolled in this open-label, single-arm trial will receive~     ofatumumab at the highest clinical dose (2000 mg) studied or planned for study. Ofatumumab~     will be administered as eight weekly intravenous (IV) infusions followed by four monthly~     infusions, beginning in Week 13, across a 25-week treatment period. Cardiovascular effects~     will be evaluated during treatment through routine 12-lead electrocardiographic (ECG)~     monitoring. The pharmacokinetic relationship between plasma concentration of ofatumumab and~     its effect on QTc interval duration will be examined. Specifically, ECG assessments will be~     collected in triplicate at baseline, at the time of maximum ofatumumab concentrations~     periodically on-therapy, and at the end of treatment. After completion of the final~     ofatumumab infusion, subjects will continue to be followed for safety and efficacy for six~     months relative to the last ofatumumab dose.~   "
187523|NCT01110018|"~     A single-centre, open-label, sequential, cross-over study to examine the safety, tolerability~     and pharmacokinetics of 3 ascending single intravenous doses, a single 1000μg oral dose and a~     single 1000μg inhaled dose of GSK573719 in healthy male volunteers.~   "
187524|NCT01110005|"~     The purpose of this study is to determine if intrapartum use of a glucose-containing solution~     will improve the outcomes in pregnant women and their babies.~   "
187525|NCT01109992|"~     This is a single-center study of subjects undergoing clinically indicated heart scans for~     evaluation of known or suspected heart disease. We will also include 10 healthy subjects~     without known heart disease. We would like to study stress testing of the heart using~     exercise and a medication called regadenoson. Imaging of the heart will be performed.~   "
187526|NCT01109979|"~     This study compares the effects of two common hormone medications on the heart and blood~     vessels of healthy post-menopausal women over the age of 45.~      The study will take place over the course of about 5 months. Each subject will take two~     different medications over two six-week periods. They will be randomized at the beginning of~     the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the~     first period, and will receive the other medication the second six-weeks of the study. At the~     very beginning of the study and at the end of each six-week treatment period, subjects will~     come to the hospital various tests including non-invasive blood vessel imaging tests, blood~     draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a~     test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment~     periods, there will be a four-week medication-free washout period.~   "
187527|NCT01109966|"~     The purpose of this study is to evaluate whether a new version of an amino acid based formula~     improves tolerance to milk in cow's milk allergic infants/young children.~   "
187528|NCT01109953|"~     The patient has been referred for an FDG PET/CT scan. FDG is a form of sugar that contains a~     small amount of radioactivity; it is used to see the size and possible spread of cancer in~     the body.~      Pictures of the body are taken on a machine called a PET/CT scanner. The purpose of this~     current study is to see if we, the investigators, can take clearer pictures of the tumor than~     we could with our routine scan method. This would allow us to better see how FDG is picked up~     by the tumor. PET/CT is presently one of the best tools for detecting cancer and determining~     its spread in the body. However, due to breathing motion, PET and CT images may become~     blurred and the location of the tumor on CT and PET images may not match. We have developed a~     new method that enables us to reduce image blurring and to measure the tumor more accurately~     on PET images. In this study we want to compare two kinds of images: those from the standard~     PET/CT scan, and the PET/CT scan pictures taken with our new method.~      If successful, we may use this new method for clinical routine in the future.~   "
187529|NCT01109940|"~     This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in~     patients with moderate to severe ankylosing spondylitis and aims to provide continuous~     treatment with AIN457 for patients in the core trial, to obtain safety and tolerability~     information. The study will address the evaluation of efficacy following doses of 3 mg/kg~     AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the~     risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue~     dosing for another 6 month period (Part 2).~   "
187530|NCT01109927|"~     Among adult patients diagnosed with type 2 diabetes, about 6% have autoantibodies directed~     against the insulin producing beta cells in the pancreas. These patients have a progressive~     beta cell destruction and most of them will be insulin dependent within 3-5 yrs. Patients~     with this latent autoimmune diabetes in adults (LADA) have a considerable remaining beta cell~     mass at diagnosis, and are suitable for evaluating new therapies for autoimmune diabetes~     Animal studies in diabetes prone mice have demonstrated potential positive effects of early~     insulin treatment, with a lower incidence of diabetes or a delay before diagnosis. The aim of~     this study was to investigate the effect of early insulin treatment of LADA patients, in~     respect to residual beta-cell function and metabolic control, compared to a group who were~     conventionally treated with diet and/or oral hypoglycaemic agents (OHA) and insulin not~     before it was clinically needed.~   "
187531|NCT01109914|"~     The aim of this study is to verify whether vaccination with Dukoral® (SBL Vaccines) induces~     an immune response in renal transplant recipients on prednisolone in combination with either~     a calcineurin inhibitor CNI) or mycophenolate mofetil (MMF).~   "
187532|NCT01109901|"~     The purpose of this study is to determine which surgical method is better for cubital tunnel~     syndrome in outcomes.~   "
187533|NCT01109888|"~     Coasting is one of the means to reduce the risk of OHSS for patients at risk for severe OHSS.~     During coasting gonadotrophin administration is withheld until serum E2 levels drop to a~     range considered safe. Prolonged coasting reduces the chance for implantation and pregnancy.~     The aim of the study is to explore whether an increased dose of GnRH Antagonist will shorten~     the coasting period without an adverse effect on cycle outcome.~   "
187535|NCT01109862|"~     The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty~     (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the~     treatment of displaced femoral neck fractures in mobile independent elderly patients, to~     determine the impact of these surgical options on the short term functional outcomes and~     complication rates, namely dislocation and the need for further surgery.~      This is a single-blinded prospective randomized clinical trial comparing functional outcome~     and complication rates of 40 patients treated with all cemented THA to a control group of 40~     patients treated with cemented bipolar HAP, in a 2 years followup.~      The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of~     functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates~     of postoperative dislocation, component loosening, need for revision and postoperative~     mortality.~   "
187536|NCT01109849|"~     Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found~     that daily stimulant therapy produced sustained growth deficits. However, no federally funded~     studies have examined the growth suppression associated with modern once a day stimulant~     medications. Therefore, this study will precisely estimate the risks of stimulant induced~     growth suppression (SIGS), examine the underlying mechanisms and develop treatments for it.~     While drug holidays and caloric supplementation are two common treatments for SIGS, there has~     been little systematic investigation of either. It is unknown if they are effective or~     feasible. Therefore, using a randomized adaptive design, we will evaluate the efficacy and~     feasibility of these two practices vs. routine monitoring of growth in 180 prepubertal~     children with ADHD. An additional 50 subjects will be treated solely with behavioral~     therapies to evaluate for growth abnormalities associated with ADHD. The study will assess~     will the risk of SIGS with ER stimulants and the underlying mechanisms while providing~     evidenced-based treatments for its management.~   "
187537|NCT01109836|"~     Aim of this randomized controlled study is to test if intensive polyintervention therapy~     including life style modifications targeting at reduction of modifiable risk factors of~     stroke can reduce the risk of post-stroke cognitive decline compared to a group of patients~     receiving standard care.~   "
187538|NCT01109823|"~     At the intensive care unit (ICU) fluoroquinolone antibiotics, like levofloxacin, are~     frequently used for the treatment of infections.~      Adequate blood levels are required for a good efficacy of the antibiotic. Due to the fact~     that levofloxacin is almost completely eliminated renally, the blood levels for this~     antibiotic are strongly influenced by the renal function. Therefore, this study aims to~     evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison~     with critically ill patients with normal renal function.~   "
187539|NCT01109810|"~     The IDEaL registry is a cooperative, observational registry focused on immunoglobulin use in~     the U.S. The registry is a deliberate and purposeful assembly of clinical and humanistic~     knowledge that is intended to act as a longitudinal database, tracking outcomes of routine~     clinical practice.~      The central goal of the registry is to provide a mechanism that allows for a better~     understanding of how immunoglobulin therapy is being used in a real-world clinical setting.~     The data gathered will help the industry gain a better understanding surrounding the~     therapeutic value of immunoglobulin therapy and subsequently improve practices, reduce~     medical costs, and ultimately improve the clinical outcomes for the patients receiving~     immunoglobulin therapy~   "
187540|NCT01109797|"~     The purpose of the study is to compare two interventions for preparing diabetic teens and~     young adults for transition from pediatric to adult diabetes care.~   "
187541|NCT01109784|"~     The use of dual antiplatelet therapy is considered standard of care in patients post~     percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of~     patients is considered clopidogrel resistant and this resistance is shown to be accompanied~     by future adverse events. Additionally, clopidogrel resistance has been linked with the~     CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients~     undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as~     estimated predischarge with the VerifyNow point of care system of platelet reactivity.~     Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or~     clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment~     crossover will be performed. At day 60 platelet reactivity will be determined as well. In~     addition, in all patients genetic determination of CYP polymorphisms (including the~     CYP2C19)known to affect clopidogrel metabolism will be performed.~   "
187542|NCT01109771|"~     To compare the use of absorbable tackers versus permanent tack fixation using a polyester~     large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian)~     prospective randomized single-blinded trial.~      All patients referred for elective midline ventral hernia repair should be assessed for~     eligibility and entered in a study log, detailing all included patients during the study~     period.~   "
187543|NCT01109758|"~     The purpose of this study is to assess how fenofibrate modify gene expression in circulating~     monocytes of healthy volunteers after 6 weeks.~   "
187544|NCT01109745|"~     The objective of this project is to establish the effectiveness of implementation of a~     self-administered electronic asthma-specific quality of life instrument for childhood asthma~     in primary care and specialist care.~   "
187545|NCT01109732|"~     The purpose of this study is to investigate how systematic physical training after~     endovascular treatment influence the durability of the endovascular treatment and how it~     effects physical function, quality of life and future cardiovascular events.~   "
187546|NCT01109719|"~     We will test whether the way that an intensive care unit is organized can influence patient~     related outcomes such as mortality. We will test whether who works in the ICU, and how the~     ICU is managed will affect the care received by patients. The primary study hypothesis is~     whether the number of clinical protocols present in an intensive care unit is linked to~     patient mortality~   "
187577|NCT01109316|"~     This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. The purpose of~     this study is to provide information on the use of insulin lispro in insulin pumps~     (Continuous Subcutaneous Insulin Infusion [CSII]) compared to insulin aspart over 6 days of~     pump reservoir in-use. The study will also compare the in-use characteristics of insulin~     lispro infused at 6 days with insulin lispro infused at 2 days.~   "
187547|NCT01109706|"~     PCSK9 (Proprotein convertase subtilisin kexin type 9) plays a key role in LDL-cholesterol~     (LDLC) metabolism by inhibiting LDL receptor (LDLR) at post-transcriptional level. PCSK9 loss~     of function mutations are associated to decreased LDLC levels and a cardiovascular~     protection. In this context, the development of pharmacological inhibitors of PCSK9, in~     association with statins treatment, represents a major therapeutic issue for LDLC modulation.~     It was previously shown that PCSK9 plasmatic concentration correlated with plasmatic LDLC, TG~     and glucose concentrations. However, no data are available on predictive value of PCSK9~     plasmatic level concerning coronary disease severity.~      The main objective of this study is to determine whether plasmatic PCSK9 concentration is~     linked to coronary damage severity in patients with acute coronary syndrome.~   "
187548|NCT01109693|"~     The purpose of the study is to establish the optimum treatment strategy for first-line and~     second-line antidepressants in the acute phase treatment of major depression.~   "
187549|NCT01109680|"~     A Single Center, Open-Label Study to quantify metabolites of [14C]-Neramexane in plasma and~     urine in Healthy Male Subjects~   "
187550|NCT01109667|"~     The aim of this study is to assess the effect of Innovin® reagent on laboratory results when~     compared with the Thromborel® S.~   "
187551|NCT01109654|"~     This is a multicentric, prospective, observational study on the use of Cetrotide to control~     the endogenous gonadotrophin levels in Gonal-f stimulated ART treatment cycles in the~     Asia-Pacific region. The study plans to enrol approximately 1800-2000 subjects over a 9-month~     period at each participating centre.~      This observational study is initiated to collect information on the use of Cetrotide (GnRH~     antagonist) in ART cycles in routine practice across the Asia-Pacific region. The information~     will allow a better understanding of the current ovarian stimulation regimens that involve~     Cetrotide in the control of the endogenous gonadotrophin concentrations. The collection of~     live birth data, though a challenging task, as a secondary endpoint will allow the study to~     show valuable information on the final objective of ART. To minimize the potential~     variability due to the different ovarian stimulation agents, the study is to include cycles~     treated with Gonal-f (recombinant human FSH) since this agent is widely available in the~     region.~   "
187552|NCT01109641|"~     The PING-EP study is designed to evaluate electrode properties on phrenic nerve stimulation~     (PNS) in coronary sinus using a commercially available diagnostic electrophysiology catheter.~   "
187553|NCT01109628|"~     The present study is designed to investigate whether timed protein supplementation will~     increase skeletal muscle mass in the frail elderly population.~   "
187554|NCT01109615|"~     This study aims to investigate the efficacy and safety of the combination of pemetrexed and~     gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with~     KRAS mutations.~   "
187555|NCT01109602|"~     Approximately 780,000 people suffer a stroke annually in the United States; 200,000 are~     recurrent strokes. The 17,000 veterans who suffer a stroke yearly are at great risk for a~     second stroke and therefore should be targeted for stroke risk factor management and~     prevention interventions.~      Balance and fear of falling negatively impact activity and function. Decreased activity and~     blood pressure (BP) are important modifiable stroke risk factors. These can be addressed~     through a yoga exercise intervention. Yoga, like tai-chi, is old world alternative medicine~     that has the potential to greatly impact the lives of older adults.~   "
187556|NCT01109589|"~     The main objective is to investigate the incidence of Respiratory Tract Infections (RTIs) and~     antibiotic prescriptions in children and during pregnancy, the different drugs chosen by~     their doctors according to diagnosis, and compliance by patients. Further to investigate the~     possible effect of antibiotic use during pregnancy on RTIs and antibiotics and respiratory~     drug prescriptions in children the first two years after birth.~      Specific study objectives:~        -  RTIs and antibiotic prescriptions in pre-school children~             -  Frequency of diagnoses and antibiotic prescriptions~             -  The proportion of broad spectrum antibiotics chosen~        -  Prescription patterns and treatment compliance during pregnancy~             -  Incidence of diagnoses, compared with not pregnant patients~             -  Choice of antibiotics in RTIs~             -  Prescription collection from pharmacies~        -  Antibiotics and respiratory medication in children aged 0-2 yrs~             -  Compare prevalence in children of mothers with frequent RTIs/antibiotic~               prescriptions during pregnancy and prevalence in children of mothers with few or no~               consultations during pregnancy~             -  Incidence of wheezing and asthma diagnoses and incidence og respiratory~               prescription drugs when the mother has received antibiotics in pregnancy~   "
187557|NCT01109576|"~     This is a pilot study of workshops to help Veterans with both vision and hearing loss live a~     happier, fuller and less stressful life. The results will be used to guide the development of~     a large scale clinical trial.~   "
187558|NCT01109563|"~     This study will test a behavioral intervention tailored for adolescents who smoke marijuana~     and have concerns about their use. The study's purpose is to determine whether this~     intervention (two-sessions of motivational enhancement intervention followed by 12 months of~     optional skills training) will be more effective in reducing the use of this drug if~     augmented by three periodic motivational enhancement treatment check-in sessions as compared~     to three periodic computer-based check-in sessions.~      HYPOTHESES: (1) Participants in the motivational enhancement treatment check-ins (MCI)~     condition will reduce their use of marijuana more than participants in the computer based~     (Comp) condition and report fewer negative consequences. These differences are expected to be~     greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a~     cumulative effect. (2)Engagement in CBT sessions will be greater for those in the MCI~     condition and will partially mediate the effect on marijuana related outcome indices. (3) The~     MCI intervention will lead to increased self-efficacy, and decreased normative perceptions of~     marijuana use by other teens that will also partially mediate the effect of the intervention.~   "
187578|NCT01109303|"~     Ankle fracture is frequent and its number is increasing. In Canada, surgical treatment of~     these lesions is advised and the options currently used all have in common a rigid fixation~     of the syndesmosis which results in residual stiffness and a high level of secondary surgery,~     mostly to remove the implant.~      The purpose of the study is to compare the treatment of ankle syndesmotic rupture by a~     dynamic fixation to a static fixation suggesting that the dynamic fixation method will~     improve the Olerud-Molander functional score of more than 15 points at the 3 months~     follow-up.~   "
187559|NCT01109550|"~     Biliary obstruction and cholangitis are common problems in gastroenterology and need specific~     therapeutic interventions. Besides a variety of potential causes, infections of the biliary~     tract with Candida and other fungal species have increasingly been reported in the last few~     years. Especially interesting is the question, if patients with positive fungal cultures of~     bile samples should be treated or not and under which circumstances. The primary aim of the~     present study is to evaluate wether positive fungal cultures of bile samples indicate fungal~     infection of the biliary tract, rather colonization or simply contamination during endoscopic~     retrograde cholangiopancreatography (ERCP) procedure.~   "
187560|NCT01109537|"~     The purpose of the study is to understand the brain chemistry of people with Restless Legs~     Syndrome (RLS). The primary hypothesis is that patients with RLS will have reduced GABA~     levels in their Thalamus and elevated Glutamate levels in their Anterior Cingulate Cortex.~     The study will use MRS imaging to examine the regional levels of these neurochemicals, GABA~     and Glutamate, in the brain.~   "
187561|NCT01109524|"~     The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used~     for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and~     Vinorelbine.~   "
187562|NCT01109511|"~     Objectives:~      Primary objective:~        -  To demonstrate that the treatment with OXN PR tablets up to 72 hrs after surgery is~          superior to the treatment with OxyPR with regards to constipation in subjects with~          postoperative pain after laparoscopic hysterectomy based on interviews 24h, 72 h and 1~          week postoperatively.~      The secondary objectives:~        -  Analgesic effect (including registration during the first 24 hrs)~        -  To asses the frequency of pain rescue mediation use (in the double-blind phase, 0-72~          hrs)~        -  Frequency of nausea and vomiting~        -  Frequency of other adverse events~        -  Appetite~        -  Mobilization~      The exploratory objectives:~        -  Overall patient satisfaction at 24, 72 hrs and 1 week~   "
187563|NCT01109498|"~     LPLD is a rare autosomal recessive disorder, characterized by the presence of marked~     chylomicronemia and hence hypertriglyceridemia. Clinically the most severe manifestation of~     chylomicronemia, is acute pancreatitis, which can be lethal. There is no effective therapy~     available to modulate the course of the illness and prevent complications for these patients.~     The current clinical management consists of severe reduction of dietary fat that is hard if~     not almost impossible to comply with. LPLD subjects continue to experience pancreatitis~     attacks, and are admitted to intensive care units on several occasions.~      Alipogene tiparvovec corrects or restores lipoprotein lipase (LPL) function long term, and~     hence reverses some symptoms, halts the disease progression and prevents further~     complications. Alipogene tiparvovec gene therapy ensures that a catabolically beneficial~     variant of the human LPL gene, LPL[S447X] is expressed and active in the relevant tissues in~     humans. Delivery of the gene is realized via intramuscular injection of an adeno-associated~     viral vector, pseudotyped with AAV1 capsids.~   "
187564|NCT01109485|"~     The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic~     Solution 0.1% in Japanese children with allergic conjunctivitis.~   "
187565|NCT01109472|"~     Study aims to improve osteoporosis care through patient tailored education materials in a~     group-randomized trial of patients referred to home health care with a history of fracture~     and/or an osteoporosis diagnosis. Project investigators will conduct telephone surveys and~     examine electronic medical record data to assess fracture related morbidity and mortality,~     osteoporosis treatment and adherence, and use of calcium and vitamin D supplements.~      We hypothesize that patients that receive the intervention materials will be more likely to~     initiate or maintain osteoporosis treatment.~   "
187566|NCT01109459|"~     Current research shows low rates of quantitative vision screening at preschool ages in the~     medical home. This study targets providers (PCPs) to evaluate the effectiveness of a~     web-based intervention to improve knowledge about strabismus, amblyopia and preschool vision~     screening, to increase preschool vision screening rates, and to improve rates of diagnosis of~     strabismus and amblyopia by eye specialists.~   "
187567|NCT01109446|"~     We wish to address the efficacy and safety of Platelet Rich Plasma (blood platelets), a new~     treatment for lateral epicondylitis (tennis elbow) and compare this new treatment to either~     injection with steroid or saline solution.~      All injections are guided by ultrasonography.~   "
187568|NCT01109433|"~     Background:~      - Uveitis, the inflammation of the interior of the eye, is responsible for numerous new cases~     of legal blindness every year. Uveitis can be caused by Beh(SqrRoot)(Beta)et s disease (BD),~     a chronic inflammatory disorder that can affect the eye, mucous membranes, and other body~     organs such as the joints, intestinal tract, blood vessels, and central nervous system.~      Objectives:~      The purpose of this study is to see how genes affect Beh(SqrRoot)(Beta)et s disease and if~     there are differences in Beh(SqrRoot)(Beta)et s disease among people of different~     backgrounds.~      Eligibility:~        -  Individuals who have a diagnosis of BD and are enrolled in another NIH study.~        -  Individuals who are willing to donate blood for the purposes of this research study and~          who are willing to have their blood stored for possible future/other research purposes.~      Design:~        -  As part of the study, blood samples will be drawn from participants when an exacerbation~          in disease activity occurs and before and after any significant change in treatment for~          BD.~        -  No treatments will be provided in this study.~   "
187579|NCT01109290|"~     Hypohidrotic ectodermal dysplasia (HED) is a complex genetic disorder characterized by lack~     of sweat glands, sparse hair, and missing or malformed teeth. Inability to sweat may result~     in episodes of severe hyperthermia and cause sudden infant death. To assess sweat gland~     function in HED patients, the investigators will first quantify gland pores in a defined area~     of the palm and then stimulate the glands by pilocarpine followed by sweat collection in a~     special capillary for volume determination. This will be combined with non-invasive skin~     conductance measurement prior and subsequent to stimulation of the sympathetic nervous~     system. The data should provide a basis for genotype-phenotype correlation.~   "
187613|NCT01108848|"~     The objective of this patient registry is to collect data on the safety of Berinert® in~     normal clinical practice in the United States. The patient registry will be maintained for a~     period of at least 3 years. The duration of individual patient participation will vary and is~     determined by the frequency of hereditary angioedema (HAE) attacks and the patient's need for~     Berinert® treatment.~   "
187569|NCT01109420|"~     Background:~      - Researchers are studying types of thyroid cancer that seem to cluster in families.~     Non-medullary thyroid cancer accounts for the vast majority of all types of thyroid cancer,~     but little is known about possible genes that may cause the cancer. More research is needed~     to develop the best ways to screen for familial non-medullary thyroid cancer (FNMTC) so that~     it can be diagnosed and treated at an early stage.~      Objectives:~        -  To evaluate the natural history of FNMTC.~        -  To determine the best screening strategy for FNMTC.~        -  To identify genes that may indicate susceptibility to FNMTC.~      Eligibility:~      - Individuals at least 7 years of age who have two first-degree relatives (e.g., parents,~     children, siblings) who have or have had non-medullary thyroid cancer or a documented~     diagnosis of non-medullary thyroid cancer and one living relative with documented~     non-medullary thyroid cancer.~      Design:~        -  Participants will be evaluated by family history pedigree, physical examination, imaging~          (including possible neck ultrasound and radioactive iodine scans), and laboratory~          testing.~        -  Participants who agree to have blood or other biological samples collected will be asked~          to enroll in an additional study to provide the appropriate samples and tissues.~        -  After the initial study evaluation, participants who are not found to have a malignant~          thyroid tumor will be re-screened every year with non-invasive imaging studies.~          Participants who are found to have a malignant thyroid tumor will be informed of~          possible treatment options.~   "
187570|NCT01109407|"~     Background:~      - Multiple myeloma is a type of cancer that affects white blood cells and has a poor~     long-term survival rate. Two other types of cancer, monoclonal gammopathy of undetermined~     significance (MGUS) and smoldering myeloma (SMM), may eventually progress and develop into~     multiple myeloma. Researchers are interested in collecting samples from individuals who have~     been diagnosed with MGUS and SMM to study possible risk factors for developing multiple~     myeloma.~      Objectives:~      - To study risk factors that may cause MGUS and SMM to progress to multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with either MGUS or SMM but do~     not have multiple myeloma.~      Design:~        -  Participants will be examined by study researchers at the initial visit, at 6 months~          following enrollment, and every 12 months for a maximum of 5 years.~        -  The following tests may be performed: (1) blood and urine tests, (2) bone marrow~          aspiration and biopsy, (3) imaging studies, and (4) a skeletal survey (a series of~          skeletal X-rays of the skull, spine, pelvis, ribs, shoulders, upper arm, and thigh~          bones).~        -  Treatment will not be provided as part of this protocol. - Participants will remain on~          the study for 5 years, or until their MGUS or SMM progresses to multiple myeloma~          requiring treatment.~   "
187571|NCT01109394|"~     Background:~      - Laboratory investigators who are studying common childhood cancers are interested in~     developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of~     children who have cancer or adults who have common childhood cancers. To develop this~     repository, additional samples will be collected from children and adults who have been~     diagnosed with common childhood cancers such as leukemia and tumors of the central nervous~     system.~      Objectives:~      - To collect and store blood, serum, tissue, urine, or tumor samples of children who have~     cancer or adults who have common childhood cancers.~      Eligibility:~        -  Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia)~          regardless of patient age.~        -  Children, adolescents, and adults who have been diagnosed with a type of cancer more~          commonly found in adults.~      Design:~        -  Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be~          collected from participants at a time when sampling is required for medical care or as~          part of a research study.~        -  No additional procedures will be performed for the sole purpose of obtaining additional~          tumor tissue, aside from what is required for clinical care.~   "
187572|NCT01109381|"~     At present, triple therapy is recommended by various guidelines for the treatment of~     Helicobacter pylori (H.pylori) infection. Recent studies have shown increasing resistance of~     H.pylori to commonly used antibiotics used in triple therapy. This study explores a~     non-antibiotic treatment regime for H.pylori that uses lauric acid as the primary~     anti-microbial agent. The study hypothesis is that Lauric acid works synergistically with~     omeprazole following administration of a mucolytic agent to kill H.pylori topically in the~     stomach.~   "
187573|NCT01109368|"~     This repository will establish for the first time a system to carefully assess and monitor~     over time the general health and the amount of cholesterol in the arteries of U.S. children~     and adults with homozygous familial hypercholesterolemia (hoFH). Patients with this very rare~     disorder have very high blood levels of cholesterol from birth due to the inheritance of an~     abnormal gene from each parent. As a result, if untreated, heart attacks and sudden death~     occur in childhood. Treatments such as LDL-apheresis and liver transplant will lower the~     cholesterol level, but the best treatment and the best way to monitor the effect of the~     treatment on the arteries are unknown. The collection of clinical data and blood for analysis~     of known and yet-to-be discovered markers and predictors of arterial disease will yield new~     information about the natural history of the disorder and response to treatment. The~     repository will greatly aid the development of specific protocols that seek to learn more~     about this disease and new therapies.~   "
187574|NCT01109355|"~     Intrathoracic positive pressure may lead to a change hemodynamics, with repercussions for the~     intracranial compartment, thereby altering intracranial pressure (ICP) and cerebral perfusion~     pressure (CPP). This effect may become more intense when using high positive end expiratory~     pressure (PEEP) values. The aim of the present study was to measure the impact of different~     PEEP values on ICP, CPP and mean arterial pressure (MAP). MAP, whereas high PEEP values~     increase ICP, although without clinical relevance.~   "
187575|NCT01109342|"~     Two previous studies of an HIV preventive vaccine, the STEP study and the Phambili study,~     were halted because people who received the vaccine were more likely to become infected with~     HIV. Why this vaccine failed is still being researched, but one reason may be related to the~     recombinant Adenovirus type 5 (rAd5) virus vector used in the vaccine. Two trials of another~     HIV preventive vaccine that used a rAd5 virus vector were conducted in Uganda. This study~     will obtain follow-up safety information on participants in those trials.~   "
189748|NCT01080833|"~     Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine~     training (study group) will demonstrate improved clinical outcomes compared to those~     undergoing routine ERCP training only (control group).~   "
187580|NCT01109277|"~     Objective: To develop an evidence-based strategy for assessing the risk of significant~     hyperbilirubinemia in healthy term and near-term (late-preterm) neonates.~      Hypothesis: A stepwise strategy which combines clinical parameters and serial non-invasive~     transcutaneous bilirubin (TcB) values could reliably predict significant neonatal~     hyperbilirubinemia.~      Methods: Data from neonates >34 weeks' gestation included in the registry for neonatal~     hyperbilirubinemia of the well-baby nursery of the University Hospital of Patras, from~     January 2008 to December 2010 will be reviewed.~      The registry includes prospectively collected data such as sex, gestational age, gestation~     and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs~     test, type of delivery and complications, birthweight, postnatal medications and~     interventions, type and volume of feeding (daily), extension of jaundice, TcB measurements at~     intervals of 12+/-4 hours until discharge, total serum bilirubin values (if obtained), TcB or~     TSB measurements at follow-up, weight at discharge, need of phototherapy (inpatient or after~     discharge). TcB and TSB values are plotted on a hour-specific chart.~      A novel predictive nomogram based on TcB measurements (Varvarigou et al. Pediatrics~     2009;124:1052-9) will be used to classify TcB values as high, intermediate, and low risk.~      Significant hyperbilirubinemia will be defined as a TSB value above the phototherapy~     threshold level according to the AAP 2004 guidelines~      Statistics: Independent and joint effects of various clinical factors on the development of~     significant hyperbilirubinemia will be evaluated by logistic regression analysis Cluster~     analysis and Chi-squared Automatic Interaction Detection (CHAID) tree method will be used to~     develop the strategy. At each step, CHAID chooses the independent (predictor) variable that~     has the strongest interaction with the dependent variable. Categories of each predictor are~     merged if they are not significantly different with respect to the dependent variable.~   "
187581|NCT01109264|"~     To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil~     for initial treatment of chronic lymphocytic leukemia~   "
187582|NCT01109251|"~     The study HIPPOCRATE is a prospective open comparative study with a control group.~      The objective of this study is to show that an optimization of the caring of non controlled~     hypertended patients following a CVA (including a preliminary Tensional auto-measure (TAM) at~     the follow-up visit, an education of the patient with a decision support tree for the~     generalist and/or a visit in the multidisciplinary AHT department), allow to obtain a better~     tensional control copared to the usual caring.~   "
187583|NCT01109238|"~     The investigators are studying new ways to make treatment decisions for these types of~     cancer. Technologies at the Van Andel Research Institute (VARI) are available to determine a~     tumor's molecular makeup (gene expression profile). This technology (called Xenobase) is~     being used to discover new ways to understand cancers and potentially predict the best~     treatments for patients with cancer. The researchers at VARI have filed a patent on the~     Xenobase and the specific network analysis method that the investigators will be using as~     part of this study.~      A specimen obtained from the tumor during a recent surgical, biopsy, or bone marrow procedure~     will be sent to the Van Andel Research Institute. Researchers will attempt to identify the~     molecular makeup within the specimen, as well as in blood and urine samples in patients with~     aggressive and/or refractory cancer. This additional testing is different than the routine~     tests currently performed at the hospital for the evaluation of cancer.~      The goals of this part of the study are: To determine if the investigators tumor board~     committee (at minimum a panel of 3 oncologists and 1 pharmacist) can use patient specific~     cancer cells to make real-time treatment decision using patient specific genetic information,~     and predicted therapies generated in the Xenobase report.~   "
187584|NCT01109225|"~     This study aims to determine whether aldosterone blood levels are predictive of cardiac~     remodeling at 6 months following myocardial infarction with ST elevation (STEMI),~     independently of conventional predictive factors (size of myocardial infarction, age,~     hypertension, etc.) in revascularized patients during the acute phase of MI.~   "
187585|NCT01109212|"~     The purpose of this study is to determine whether bindarit is effective to reduce~     albuminuria, compared to placebo, in nephropathic patients treated with irbesartan, as a~     background therapy.~   "
187586|NCT01109199|"~     This 18 week, randomized, double blind, placebo controlled trial will examine the effects of~     thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight~     loss, body composition, and compliance in overweight and moderately obese female.~      The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a~     14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the~     rice flour supplementation of the LCD.~   "
187587|NCT01109186|"~     BK virus infections are very frequent during months following a kidney transplantation: a~     viral reactivation is observed for almost 50% of patients during first year. This~     reactivation leads to a viremia for 10 to 15% of patient during this same period. The most~     frequent complication is interstitial nephritis for 2 to 8% of patients (27 patients~     representing 2.7% during 6 years in Nantes).~      An intensive et persisting viral replication, assessed by detection of high blood viral load,~     could evolved to a viral nephropathy which lead to a very pejorative functional issue for the~     graft.~      Biological follow-up of these infections lay on the measures of viral load. Their positivity~     must alert the physician and lead him to modulate immunosuppressive treatment.~      Actually, there is no real consensus about the modalities of pharmacological~     immunosuppression decrease (decrease dose or change of molecule).~      Specific lymphocytic anti-BKv evaluated on several cohorts of patients permit to prove:~        -  weakness of immune cellular response for patient with high viremia~        -  increase of this response when viral load decrease These studies laid on detection of~          INFg synthesis by Elispot after stimulation with viral antigens and in vitro cellular~          expansion.~      New prospective and longitudinal data comparing the immune cellular response (systematic and~     early) after graft between patients controlling or not BKv infection are necessary to improve~     the comprehension of illness natural history.~      The investigators propose to enlarge the investigation of anti-BKv immune cellular response~     to other functions than IFNg synthesis in the aim of detecting the eventual role of~     polyfunctional lymphocytes for infection control. Furthermore, the investigators propose to~     identify better diagnostic and prognostic makers.~   "
187588|NCT01109173|"~     The purpose of this study was to assess the safety and efficacy of an investigational eye~     drop intended for the prevention and treatment of inflammation (swelling and redness) and~     pain in the eye after cataract extraction.~   "
187589|NCT01109160|"~     This study investigates the role of azithromycin treatment for lymphocytic~     bronchitis/bronchiolitis after lung transplantation.~   "
187590|NCT01109147|"~     After an initial screening visit, including an assessment of psychiatric disorders, patients~     stabilized on antipsychotic medication (aripiprazole or risperidone) for at least 6 weeks and~     control subjects will undergo an assessment using functional magnetic resonance imaging~     (fMRI) of the differences of patterns of brain activation during an emotional task~   "
187593|NCT01109108|"~     The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary~     care clinic at Boston medical center on the serotype specific carriage of Streptococcus~     pneumoniae in children < 5.~      Specifically the investigators will measure the decline in vaccine serotypes, the proportion~     of children receiving vaccine required to achieve 50% reduction in serotype specific carriage~     and the correlation between immunogenicity of the specific serotypes and decline in carriage.~     The study has been extended to complete 5 years of surveillance to determine the new SP~     serotype distribution at the time presumably a new equilibrium has been achieved.~   "
187594|NCT01109095|"~     This study is for patients that have a type of brain cancer called glioblastoma multiforme~     (GBM).~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including cells infected with~     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with~     cancers. They have shown promise, but have not been strong enough to cure most patients.~      The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor~     2). This antibody sticks to GBM cells because of a substance on the outside of these cells~     called HER2. Up to 80% of GBMs are positive for HER2. HER2 antibodies have been used to treat~     people with HER2-positive cancers. For this study, the HER2 antibody has been changed so that~     instead of floating free in the blood it is now attached to T cells. When an antibody is~     joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T~     cells seem to be able to kill tumors like GBM, but they don't last very long and so their~     chances of fighting the cancer are limited. Therefore, developing ways to prolong the life of~     these T cells should help them fight cancer.~      We found that T cells work better if we also attach a protein called CD28 to the HER2~     chimeric receptor (HER2-CAR). In this study we placed this HER2-CAR into T cells that were~     pre-selected for their ability to recognize Cytomegalovirus (CMV). This virus exists in most~     people. These CMV-specific cytotoxic T cells (CMV-T cells) will be more active since they~     will react to the virus as well as to tumor cells. These HER2-CD28 CMV-T cells are an~     investigational product not approved by the Food and Drug Administration.~      The purpose of this study is to find the largest safe dose of HER2-CD28 CMV-T cells, to learn~     what the side effects are, and to see whether this therapy might help patients with GBM.~   "
187595|NCT01109082|"~     The goal of this study is to evaluate children and adolescents with idiopathic scoliosis who~     are undergoing spinal fusion using motion analysis, balance, and outcome questionnaires.~     Little research has been done to evaluate how different fusion levels impact walking~     patterns, range of motion, posture and balance following spine instrumentation in children~     with idiopathic scoliosis. Debate still continues whether posterior spinal instrumentation~     with the last instrumented vertebra at or above Lumbar 3 (L3) will provide sufficient spine~     correction, greater motion, and better posture and balance when compared to a child with~     instrumentation at Lumbar 4 (L4). Furthermore, how does the spine fusion endpoint (last~     instrumented vertebra) impact quality of life, participation, and impairment in children and~     adolescents with idiopathic scoliosis and how do they compare to healthy age-matched peers.~     The goal of this study is to compare these two end points using gait analysis, postural~     stability, and outcome tools with the hopes of providing better clinical care to children~     with idiopathic scoliosis.~   "
187596|NCT01109069|"~     The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen~     of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small~     lymphocytic leukemia (CLL/SLL).~   "
187597|NCT01109056|"~     This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05%~     (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).~   "
187598|NCT01109043|"~     The b.p.m study will be performed to gain the insight in the courses of illness and therapy~     in subjects, suffering from hypertension and that have elevated heart rate. This study will~     show that a therapy with bisoprolol (Concor/Concor PLUS) or any other blood pressure lowering~     (antihypertensive) drug lowers blood pressure (BP) and heart rate and increases the quality~     of subjects' life.~   "
187599|NCT01109030|"~     The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is~     effective in treatment of moderate to severe depression~   "
187600|NCT01109017|"~     This study is conducted in Japan. The aim of this observational study is to collect~     information about the safety and efficacy of Norditropin® long-term treatment of growth~     hormone deficiency in adults.~   "
187601|NCT01109004|"~     The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus~     maintenance therapy versus the strategy of single autologous transplant plus consolidation~     therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy~     or single autologous transplant plus maintenance therapy as part of upfront treatment of~     multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in~     all arms.~   "
187602|NCT01108991|"~     Chronic obstructive pulmonary disease (COPD) is a common condition associated with major~     disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and~     is cost saving, but fewer than 2% of patients have access to these programs. New methods of~     PR are needed to increase access of patients with COPD to these established benefits. To~     address this gap we propose a novel physical activity self-management (PASM) program based on~     an evidence-based physical activity intervention designed to increase physical activity and~     quality of life. Key components of the program include tailored telephone counseling, a~     workbook, and computer-assisted telephone follow-up. We will test the following two~     hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically~     significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire~     [CRQ] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM~     program is more cost-effective compared to the UC. The project addresses a major gap in the~     current management of COPD and may provide a novel, cost-effective strategy for improving~     functional performance and health status.~   "
187603|NCT01108978|"~     The purpose of this study is to evaluate the Efficacy and Safety of Dehypotin® in the~     Patients with Type 2 Diabetes Mellitus or Cardiovascular Disease. Eligible patients will be~     randomly assigned to 1 of 2 arms, either Dehypotin® or placebo, and will receive the diet~     advisement throughout the study.~   "
187614|NCT01108835|"~     Objective: Chronic obstructive pulmonary disease (COPD) is a disease with significant~     morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital~     admissions related to COPD is the single largest source of expenditure in the public hospital~     system. This study aims to assess whether a comprehensive care programme can decrease the~     rate of hospital admissions for COPD patients.~   "
188931|NCT01091532|"~     The purpose of this study in healthy people is to investigate the safety, toleration and time~     course of UK-396,082 concentration in the blood and any changes in relevant markers of drug~     effects, following multiple doses given twice daily by mouth for 14 days.~   "
187604|NCT01108965|"~     The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in~     hydrocephalic shunts.~      The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients~     with external ventriculostomies and extra-ventricular drainage systems. The sensor~     measurements will be compared with the volume of fluid collected by the drainage bag.~      After a 24-hour measurement period, the doctor will change the drainage bag position to~     simulate the patient sitting up and leaning back, to see if this temporarily stops flow~     through the drainage line.~      This data will show whether the sensor accurately measures typical drainage flows seen in~     hydrocephalus patients. This research will help develop an implantable flow monitor for~     pediatric hydrocephalus patients.~   "
187605|NCT01108952|"~     Background: While treatment for pediatric cancer has improved significantly over the past 40~     years, the neurotoxic side-effects of the chemotherapy agents themselves are now being~     recognized. Two drugs suspected of having acute impact on memory performance in children are~     methotrexate (MTX) and steroids (GCs). In addition, new evidence suggests that this~     neurotoxicity might actually protect these children from traumatization.~      Working hypothesis and aims: This project aims to examine the acute impact of MTX and GC~     chemotherapy on memory performance in children and young adults with cancer, and the~     subsequent impact on the development of traumatic symptoms. We hypothesize that MTX and GCs~     will each produce acute declines in memory performance and that children with greater~     reductions in memory performance will have fewer traumatic symptoms.~      Methods: The investigators will recruit 45 children being treated with MTX or GCs at Dana~     Children's Hospital. To determine acute impact on memory, a battery of memory tests will be~     administered before and after a cycle of MTX and before and after a cycle of GCs. In~     addition, traumatic symptoms will be assessed at each post-chemotherapy evaluation point~     Expected results: The investigators expect poorer memory performance after MTX and after GCs~     and that these performance declines will correlate with lower rates of traumatic symptoms.~      Importance: The immediate impact of MTX and GCs on memory is not well known, especially in~     children. In addition, recent findings have led us to hypothesize that chemotherapy-induced~     deficits in memory function would paradoxically protect these patients from the~     traumatization often associated with cancer and its treatment. The proposed study will test~     this novel hypothesis for the first time.~   "
187606|NCT01108939|"~     Anemia is still a main public health problem in sub-Saharan Africa. Anemic women have an~     increased maternal and perinatal mortality and anemic adults have diminished work capacity.~     In sub-Saharan Africa, the etiology of anemia is multifactoral; the major causes are low~     dietary bioavailability and chronic parasitic infections such as malaria. These causes are~     likely to interact because infection and infection-associated inflammation may impair the~     utilization and absorption of iron. Therefore, the control of parasite infections may be~     important to improve iron bioavailability from foods.~      Malaria infections are endemic in northern Benin. To investigate the contribution of~     asymptomatic malaria (a positive blood smear for malarial parasites but without clinical~     symptoms of fever, headache or malaise) to anemia, we are planning a human iron absorption~     study in Benin. We will recruit adults with asymptomatic malaria infection. The iron~     absorption and utilization of the study subjects will be studied while infected, then they~     will be treated to clear their infections, and then iron absorption and utilization will be~     restudied. Iron absorption will be determined by incorporation of labeled iron into~     erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable~     isotope technique). Subjects will be men and non-pregnant, non-breastfeeding women with a~     body weight < 65 kg and between the age of 18 - 30 years.~      The results of this study will provide important information on the influence of malaria~     infections on iron absorption and utilization in humans. The study will provide insight into~     the potential necessity of malaria control to ensure iron bioavailability from foods in~     developing countries.~   "
187607|NCT01108926|"~     The purpose of the study is to look at the levels of three HIV medications: tenofovir,~     emtricitabine, and efavirenz in blood after the drug intake has been stopped in order to~     understand how long these drugs persist in the blood. The study will specifically look at~     blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for~     14 days.~      This study is not randomised which means that all subjects will receive all study medications~     in the same order. You and the study doctor will know which study medications you are taking~     at all times during the study.~   "
187608|NCT01108913|"~     The purpose of this study is to determine whether inhalation of Bimosiamose is safe and~     effective in the treatment of patients with moderate to severe Chronic Obstructive Pulmonary~     Disease (COPD)~   "
187609|NCT01108900|"~     In the present study, it is planned to observe a population of 100 ED patients treated~     previously with udenafil and for whom their physician decided to switch them to sildenafil~     because of poor udenafil tolerance and/or poor efficacy.~   "
187610|NCT01108887|"~     RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy.~     Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may~     improve patient satisfaction and adherence to therapy. The objectives of this study are to~     evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing~     multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge.~   "
187611|NCT01108874|"~     The purpose of this study is to find the best dose of metaraminol to be used in patients~     during elective cesarean sections.~   "
187612|NCT01108861|"~     This is a prospective, randomized, multi-center study recruiting patients with an in-stent~     restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn~     endoprosthesis (W.L. Gore & Associates), a heparin-bonded endoprosthesis, is compared with~     plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80~     Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no~     evidence of restenosis or occlusion within the originally treated lesion based on color-flow~     duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target~     lesion revascularization (TLR) within 12 months.~      In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore &~     Associates) will result in greater 12 month primary patency of treated superficial femoral~     artery in-stent restenotic lesions.~   "
188932|NCT01091519|"~     Collect information on treatment with Toviaz (fesoterodine) under ordinary prescribing~     conditions, and to investigate whether additional educational information affects~     satisfaction with treatment as perceived by the patient.~   "
187615|NCT01108809|"~     The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood~     pressure and its ability to reduce different indicated cardiovascular risk scores. The study~     will also evaluate the current antihypertensive treatment pattern in the daily practice among~     the patient population at increased cardiovascular risk.~   "
187616|NCT01108796|"~     This post-marketing surveillance study is designed to supplement the data on efficacy and~     tolerability of Micardis® and MicardisPlus® in patients at cardiovascular risk under general~     practice conditions.~      The aim of the study is to investigate the effect of a six-month treatment with Micardis® /~     MicardisPlus® on blood pressure and the effect of the Lifestyle education tool for weight~     reduction on blood pressure control.~      In addition, the post-marketing surveillance study will provide information on the effects on~     target measurement of the Lifestyle education tool and various laboratory parameters produced~     by treatment with Micardis® and MicardisPlus® in an unselected patient population under~     general practice conditions.~   "
187617|NCT01108783|"~     The objective of the study was to determine the efficacy and tolerability of 20 mg of~     Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic~     Rhinitis.~   "
187618|NCT01108770|"~     To characterize skin properties in male subjects with HED~   "
187619|NCT01108757|"~     The study will assess the risk of catheter associated urinary tract infection in women~     undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic~     or placebo at the time of catheter removal. The investigators hypothesize that prophylactic~     antibiotics will reduce the rate of infection.~   "
187620|NCT01108744|"~     The study goal is to compare the management of increased intra-cranial pressure (ICP) using~     3% hypertonic saline vs. mannitol (given in same osmolar loads).~      Primary hypothesis:~      1. Hypertonic saline will be non-inferior to mannitol in decreasing elevated ICP.~      Secondary hypotheses:~        1. Hypertonic saline therapy will result with fewer complications than mannitol~        2. ICP reduction duration will be longer using hypertonic saline when compared with~          mannitol~   "
187621|NCT01108731|"~     Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for~     completing complex tasks relative to placebo.~   "
187622|NCT01108718|"~     The purpose of this research study is to determine if a new mattress relieves the symptoms of~     fibromyalgia and improves sleep, and if this is the case, whether one type of mattress is~     better than the other in doing so.~   "
187623|NCT01108705|"~     The purpose of this study is to determine whether brivanib is an effective treatment for~     liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.~   "
187624|NCT01108692|"~     This study investigates if the early detection and treatment of supraventricular arrhythmia~     (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.~      The primary endpoint investigates the delay to implement treatment in two groups of patients~     :~        -  Active group: Patients followed by telecardiology.~        -  Control group: Patients followed in the conventional manner.~      It is assumed that the delay to implement treatment will be higher in the Control group.~   "
187625|NCT01108679|"~     The purpose of this study is to examine how Buprenorphine, a form of opioid addiction~     treatment, changes the ability to think and reason among people addicted to opiates, who are~     either HIV negative or HIV positive. In addition, blood samples will be stored for HIV+ and~     HIV- individuals who take buprenorphine to study its effect. We hypothesize that the HIV~     positive participants will demonstrate significant improvement in thinking and reasoning~     ability at 3 and 6 months compared to baseline, but that their thinking and reasoning ability~     will still be lower than HIV negative participants. We also hypothesize that the biomarkers~     in participants' blood samples will be associated with measures of change in thinking and~     reasoning ability.~   "
187626|NCT01108666|"~     Seventy two patients are being asked to take part in this research study because they have~     been diagnosed with Stage IIIA or IIIB non-small cell lung cancer (NSCLC). This study is~     being done to determine the highest safe dose of proton beam radiotherapy and/or study drug~     (called Nelfinavir) that can be given with concurrent chemoradiotherapy to patients with~     cancer without causing bad side effects; and to develop biomarker for clinical outcome. This~     study will be done in two phases. In the first phase, feasibility will be established. We~     will follow patients treatment courses and record side effects at the standard proton~     radiation dose that can be given together with Cisplatinum + Etoposide or Carboplatin +~     Paclitaxel. In the second phase, we will see if it is possible to increase the total proton~     radiation dose or study drug without increasing the number of bad side effects while treated~     together with chemotherapy drugs.~   "
187627|NCT01108653|"~     In this study the investigators aim at comparing the effect on quality of life and the~     cost-effectiveness of a structuralised sick-leave program compared to usual care sick leave~     management in patients after an acute non ST myocardial infarction(NSTEMI).The investigators~     hypothesize that a structuralised sick-leave program after an acute NSTEMI is cost-effective~     without a negative effect on quality of life compared to usual care management in this~     patient group.~   "
187628|NCT01108640|"~     The specific aim of this study is to identify the degree of correlation between real time~     subcutaneous glucose monitoring and intermittent glucose monitoring using capillary glucose~     samples, arterial blood samples and venous blood samples in critically ill surgical patients.~     A secondary aim will be to determine the accuracy of real time glucose monitoring.~   "
187629|NCT01108627|"~     Asthma is the most common chronic disease of childhood affecting 6.2 million children between~     2 and 18 years of age, and is the most common cause of school absenteeism due to chronic~     disease. African American children are 3 to 4 times more likely to be hospitalized for asthma~     and 4 to 6 times more likely to die from the disease compared to European Americans. The~     economic burden in this country from asthma is enormous, exceeding $16 billion in 2004.~     Though there is no cure for asthma, several drugs are available that have been shown to be~     generally safe and effective in controlling symptoms. Beta 2 agonists are the most commonly~     used asthma drugs. When inhaled these drugs relax cells in the lungs, which helps patients~     with asthma breath easier. Two types of beta agonists in use are short-acting beta agonists~     (SABA) and long-acting beta agonists (LABA). SABA, like albuterol, are used to provide quick~     relief of chest tightening which help patients to breathe easier. Long-acting beta agonists~     (LABA) also help patients breathe easier and for a longer period of time. Continued SABA use~     (for example, inhale albuterol 3 or 4 times a day) is not recommended, and continued LABA use~     is recommended only if used together with inhaled corticosteroids (ICS). ICS are the most~     commonly used drug used in asthma that protects against inflammation in the lung. Studies~     over the past 50 years suggest that continued use of SABA, LABA, and the combination of~     ICS+LABA may worsen asthma in some patients by reducing the effect of the beta agonists,~     increasing the rate of asthma attacks, decreasing the ability of the lung to work~     efficiently, and death. Recent studies suggest asthma worsening by continued beta agonist use~     occurs in individuals with a certain genotype. Genotype refers to form of the protein, called~     the beta2 adrenergic receptor (b2AR), in the lung that beta agonists work on. Because of~     differences in genetic make up, there are different forms of the b2AR. One form is called the~     Arg16 genotype the other form is called the Gly16 genotype. Compared to Gly16 genotypes,~     patients with asthma genotyped as Arg16 appear to be more susceptible to asthma worsening~     that has been associated with continued use SABA, LABA or ICS+LABA. Most of the studies of~     the influence of genotype on asthma worsening associated with beta agonist use have been~     performed in adults. The results of a small number of studies suggest children are more~     susceptible to asthma worsening from chronic beta agonist use compared to adults, and that~     children with the Arg16 genotype are more susceptible to having asthma attacks than children~     with the Gly16 genotype. Some evidence suggest that children with asthma should not be~     treated with ICS+LABA, yet since 2000, the rate at which children with asthma are switched~     from ICS therapy alone to ICS+LABA has increased significantly. The major question posed by~     the proposed study is: Does treatment with ICS+LABA compared to ICS alone cause worsening of~     asthma in children with asthma genotyped as Arg16 homozygotes but not in Gly16 homozygotes?~     The specific aim of the project is to evaluate the safety of ICS+LABA in children with asthma~     when separated according genotype. Children with asthma will be screened, be assented and~     their care taker (parent, for example) consented. A sample of saliva will be collected from~     which genetic material (DNA) will be collected for the purpose of genotyping. A total of 90~     European and African American children, 45 Arg16 and 45 Gly16 genotypes, will be treated for~     16 weeks. Half of each genotype will be randomly assigned to receive ICS alone for 16 weeks~     the other half will receive ICS+LABA. At the end of 16 weeks, those starting with ICS will be~     then receive ICS+LABA while those who received ICS+LABA first will then take ICS alone.~     Before and once a month during treatment, each participant will visit the clinic to undergo~     tests that will assess lung function, how well asthma is being controlled, level of~     inflammation and quality of life. The results of our study are expected to have a major~     impact on the way children with asthma are being treated with drugs. If the results of our~     study show that Arg16 genotypes have worse asthma when they are taking ICS+LABA compared to~     ICS alone we will conclude that the safety of combination in children is questionable and~     should be tested in a larger population of children to determine if this popular combination~     should be used in children with asthma. If the results show that the combination in both~     genotypes does not worsen asthma compared to ICS treatment, we will conclude that the~     combination is safe to use in children, at least for 16 weeks.~   "
187630|NCT01108614|"~     The purpose of this study is to reduce the HIV/HCV incidence among the clients attending~     community-based methadone maintenance treatment (MMT) , and to prevent the secondary sexual~     transmission from HIV+ clients to their spouse and sex partners, through intensified~     comprehensive intervention.~   "
187656|NCT01108276|"~     This is an investigator-initiated prospective, randomized, controlled study.~     Hypothesis/Objective: The study will evaluate the rates of wound healing among patients with~     lower extremity diabetic wounds comparing two groups of patients. Group 1, the control group,~     will be treated with the standard of care treatment of moist wound therapy. Group 2 will be~     treated with ConvaTec Engenex® NPWT. Both groups will be treated in the inpatient and~     outpatient setting. It is expected that the NPWT device will be an effective therapy that~     expedites time to closure and demonstrates a significant decrease in the size and depth of~     the wound over the course of the 12 week therapy as compared to the standard of care.~   "
187631|NCT01108601|"~     Cisplatin and carboplatin induce ototoxicity manifested as sensorineural hearing loss,~     tinnitus, and/or vestibular disturbances. Ototoxicity is induced via damage to inner ear~     structures by reactive oxygen species. Previous animal studies demonstrated that~     transtympanic injection of Ringer's Lactate (RL) provided near complete otoprotective effect~     against cisplatin. The purpose of this study is to determine if transtympanic administration~     of Ringer's Lactate via a pressure equalising (PE) tube in patients undergoing platinum based~     chemotherapy treatment will prevent tinnitus, vestibular dysfunction and hearing loss~     especially at high frequencies. Pre- and post- chemotherapy treatment audiometry will be~     measured and statistically analysed for significance.~   "
187632|NCT01108588|"~     This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and~     Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet~     function assays~   "
187633|NCT01108575|"~     A growing body of knowledge has documented that the diaphragm, the primary muscle of~     breathing, atrophies and weakens within days of instituting mechanical ventilation support.~     Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or~     breathing without ventilator support. This study will test whether instituting a diaphragm~     strength training rehabilitation program will reduce the time patients require mechanical~     ventilation in a surgical intensive care setting.~   "
187634|NCT01108562|"~     This study will focus on patients undergoing total hip arthroplasty and Loma Linda University~     Medical Center & East Campus. These patients will be randomized to receive a low dose~     lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. These~     groups will be compared to one another statistically to determine which group shows the~     safest and most satisfying pain control.~   "
187635|NCT01108549|"~     To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy,~     sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia~     (CFS/FMS).~   "
187636|NCT01108536|"~     This study centers around the imaging of internal structures of residual limb by means of~     modern radiographic imaging techniques (Dynamic Radiography-DRSA).~      The purpose of our research is to further study the behavior of bones and soft tissue of the~     socket-stump interface during dynamic tasks such as walking or brisk walking. In the long~     term this research could prove a basis for improvements in the general design of sockets for~     the new generation of prosthetic devices.~   "
187637|NCT01108523|"~     This study evaluates HP828 in the management of moisture associated skin damage after 15 days~     of use.~   "
187638|NCT01108510|"~     The objective of this study is to evaluate the safety and efficacy of a regimen containing~     cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate~     (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir~     (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.~      Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA~     level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.~   "
187639|NCT01108497|"~     We will study gene and protein expression in leukemia cells of children diagnosed with acute~     leukemia. We hope to identify genes or proteins which can help us grade leukemia at diagnosis~     in order to: (a) develop better means of diagnosis and (b) more accurately choose the best~     therapy for each patient.~   "
187640|NCT01108484|"~     A program of exercise, diet and psycho-emotional support could improve some outcomes in~     cancer survivors.~   "
187641|NCT01108471|"~     We aim to assess a new pulse oximeter which measures continuous hemoglobin concentration~     (SpHb) in healthy patients undergoing elective Cesarean delivery (CS). This patient~     population often experiences significant blood loss during surgery, and measurements of~     surgical blood loss are often inaccurate. We will compare measurements of SpHb with estimated~     blood loss during the perioperative period, and laboratory measurements of hemoglobin at set~     time intervals during the perioperative and postoperative periods (to evaluate the accuracy~     of this device's ability to measure continuous SpHb).~   "
187642|NCT01108458|"~     A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory~     pancreatic adenocarcinoma~   "
187643|NCT01108445|"~     To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic~     renal cell carcinoma (mRCC) with non-clear cell pathology.~   "
187644|NCT01108432|"~     Our overall goal is to advance science related to using the Internet in health services~     delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed~     intervention is the first Internet-delivered intervention to target the dental microsystem~     for smoking cessation-providing access to hygienists and patients.~   "
187645|NCT01108419|"~     The aim of the study is to assess the safety and tolerance of a new fermented food versus a~     control product in healthy adults during the 4-week consumption period.~   "
187646|NCT01108406|"~     The objective of this study is to assess the long-term safety and quality of life improvement~     of the Sonitus SoundBite Hearing System.~   "
187647|NCT01108393|"~     The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of~     Obsessive and Compulsive symptoms after 16 weeks of treatment.~   "
187648|NCT01108380|"~     For patient with liver cirrhosis who need to right or extended right hepatectomy, we will~     treat with autologous peripheral stem cells transplantation to facilitate liver regeneration.~     We will asses liver regeneration by evaluation of liver volume and liver function test.~   "
187657|NCT01108263|"~     -  After determining if subjects meet the criteria to be included in the study they will be~          randomly placed in either Group 1 or 2 and patient will be blinded from randomization~          group.~        -  Subjects will walk across a pressure plate to determine different areas of high pressure~          under the foot. This will be done before the INTEGRA application and at every other~          follow-up visit.~        -  Both groups will be debrided and have pictures taken in the OR~        -  Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and~          Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected~          subcutaneously in the OR.~        -  Subjects will be placed in a total contact cast at each visit.~      If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the~     status of the healed ulcer will be assessed.~   "
187649|NCT01108367|"~     In men, urinary incontinence (UI) is relatively uncommon, and usually associated with some~     forms of prostate surgery. Thus, one of the risks of surgery for benign prostate hyperplasia~     (BPH) is postoperative UI. The guidelines of the American Urological Association for BPH~     treatment indicate that UI (2~5%) is relevant complications after transurethral prostatectomy~     (TURP). Rassweiler et al., based on a review of publications stated that early UI may occur~     in up to 30-40% of patients after TURP. Rigatti et al. reported that early postoperative~     urgency UI occurred in 38.6% (TURP) and 44% (holmium laser enucleation of the prostate;~     HoLEP) of surgically treated patients at 1-month after the surgery. Recently, the follow-up~     data for patients treated with HoLEP showed that transient stress UI developed in up to 44%~     after HoLEP. Although this alternative surgical treatment such as HoLEP can be performed~     safely with minimal complications, patients often face debilitating UI during the~     postoperative period before any improvement in micturition parameters occurs. Although this~     symptom ameliorates within a relatively short time, it usually cause significant stress and~     anxiety to the patient as far as their durations is concerned. In addition to its economic~     cost, UI is a distressing condition that has major impacts on a patient's quality of life.~     Social withdrawal, isolation, and depression occur in some patients.~      Because this problem is usually temporary, there has been little attempt at addressing the~     issue. Therefore, there has been no research devoted specifically to transient de novo UI~     associated with HoLEP.~      1. The aim of the present study was following:~        1. to investigate the incidence of transient de novo UI after HoLEP for BPH~        2. determine the predictors of early postoperative transient de novo UI.~   "
187650|NCT01108354|"~     The aim of the present proposal is to prove that adult attention deficit hyperactivity~     disorder (ADHD) patients show lower serotonin transporter (5-HTT) binding using positron~     emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT~     binding will be quantified in 20 adult medication-free ADHD patients (50% females) and in 20~     age- and sexmatched healthy controls. Investigating untreated adult ADHD patients without any~     psychiatric comorbidities will provide the opportunity to estimate the change of serotonin~     transporter binding in adult ADHD patients compared to a group of healthy controls. Several~     lines of evidence support the hypothesis that serotonergic neurotransmission may, in addition~     to dopamine, play an important role in the aetiology of ADHD. So far, no PET study~     investigating serotonergic neurotransmission in adult ADHD patients has been conducted,~     although alterations in the serotonin system may be substantially involved in the~     susceptibility and subtype characterization of ADHD.~   "
187651|NCT01108341|"~     The primary objective of the study is to determine the efficacy, as measured by overall~     response (complete response + partial response) of bendamustine in combination with~     ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma~     (NHL).~   "
187652|NCT01108328|"~     The objective of the study is to compare subjective appetite ratings and after-meal and 24~     hour blood glucose levels within overweight and obese female subjects consuming either a~     standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX~     (treatment) or a rice flour (placebo control). Each treatment phase will be 3 days in length~     and separated by 3 week washout phase, so subjects will also be acting as their own control.~     Subjects will be randomized to either start with the low calorie diet with PGX or the low~     calorie diet supplemented with rice flour. We hypothesize that the 3 day LCD with PGX will~     elicit an improved appetite score compared to the 3 day LCD supplemented with the rice flour~     placebo control.~   "
187653|NCT01108315|"~     Cancer symptoms due to disease progression or side effects caused by cancer treatment are~     prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided~     with patient education materials and counseled on anticipated side effects while being~     provided with different self-management options and warnings regarding when medical care is~     required. Despite these efforts, many people feel set adrift in having to self-manage~     treatment and illness related symptoms at home resulting in a sense of burden for the patient~     and the caregiver.~      When the patient does visit the doctor, they increasingly are asked questions to elicit~     information about symptoms and performance using structured questionnaires that are shown to~     give reproducible, meaningful, quantitative assessments of how patients feel and how they~     function—measures that are called patient reported outcomes or PROs. The questionnaires used~     to collect this information are called PRO instruments. The use of PRO instruments is part of~     a general movement toward the idea that the patient, properly queried, is the best source of~     information about how he or she feels. The goal of using PRO measures is to provide better~     information to doctors and patients so that the best treatment for patients can be~     determined.~      PURPOSE: To reduce the isolation of patients/caregivers from the medical care team and to~     improve patient/provider communication and clinical decisions by keeping documented daily~     reports of patient symptoms online, having notifications sent to the medical team of moderate~     to severe symptoms and by reviewing these reports at clinic visits with the medical staff.~   "
187654|NCT01108302|"~     This cluster randomized community-based trial is designed to test the hypothesis that the~     intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor~     by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary~     Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from~     9% to 5%) relative to home births attended by the same type of provider who does not provide~     the intervention drug. The study will also document correct use of oxytocin in Uniject,~     adverse maternal and fetal events associated with inappropriate use and a number of~     indicators reflecting the programmatic feasibility of implementing this intervention.~   "
187655|NCT01108289|"~     This study is designed to test the hypothesis that the intramuscular administration of 10 IU~     of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO)~     at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative~     to home births attended by the same type of provider who does not provide a uterotonic drug.~   "
187658|NCT01108250|"~     This study is to investigate whether variants in the LOC387715 locus and the HtrA serine~     peptidase 1 (HTRA1) gene within the 10q26 locus are associated with polypoidal choroidal~     vasculopathy and whether they are associated with clinical patterns including angiographic~     phenotype in a Korean population.~   "
187659|NCT01108237|"~     This investigation is intended to provide clinical information about alignment using~     TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will~     be compared to a historical control study, which compares alignment results of computer aided~     surgery (CAS) and conventional surgical techniques.~      The purpose of this investigation is to determine whether TruMatch™ alignment is non-inferior~     to alignment achieved with conventional instrumentation. This investigation will compare long~     leg alignment in total knee replacement achieved by the two types of procedures. Radiographic~     analysis will be performed by the same independent radiographic reviewer as the historical~     control study.~   "
187660|NCT01108224|"~     The purpose of this study is to determine whether an intervention to breast cancer patients~     including psycho-education and group psychotherapy can enhance quality of life and survival.~   "
187661|NCT01108211|"~     This is a prospective randomized controlled trial investigating the effect of vibration~     therapy on bone mineral density (BMD) and bone quality in AIS subjects suffering from~     osteopenia (low bone mass).~   "
187662|NCT01108198|"~     During last years topical steroid creams have been suggested to be effective treatment for~     non-retractable foreskin instead of circumcision.~      Aim of this study is to investigate the efficacy, safety and persistence of treatment results~     of a medium potent steroid cream in a double-blind, randomized, placebo-controlled study.~   "
187663|NCT01108185|"~     The aim of this post-marketing observational study (PMOS) is to describe the relief of~     symptoms, tolerability and compliance of treatment with Klacid®SR in a dose 1000 mg once~     daily in patients with lower respiratory tract infection or in patients with acute~     exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).~   "
187664|NCT01108172|"~     The purpose of this study is to see whether a Virtual Ward reduces readmissions after~     hospital discharge.~   "
187665|NCT01108159|"~     We will use new technologies to look at the DNA, RNA, proteins, and metabolites in the~     disease-containing blood, bone marrow, or tissue and normal cells from the skin. Our goal is~     to analyze all of the genes in the diseased and normal skin sample. By comparing the results~     of the diseased sample and normal skin cells and the results of the two types of genetic~     information (DNA and RNA), we should be able to identify genetic changes that are important~     for the initiation, progression, or treatment response of that particular disorder.~   "
187666|NCT01108146|"~     To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions)~     and overall symptomatology in patients meeting criteria of complex chronic PTSD.~   "
187667|NCT01108133|"~     There is evidence that glucocorticoids have an impact on intrusive memories in patients with~     posttraumatic stress disorder (PTSD). Hydrocortisone impairs intrusive memory retrieval~     whereas dexamethasone should strengthen intrusions in PTSD. We, the investigators, want to~     investigate (1) the effect of these two glucocorticoids on traumatic memories and (2) assess~     the neural correlates using the script-driven imagery paradigm in the functional magnetic~     resonance imaging (fMRI) scanner. We hypothesize that intrusive memories are less intensive~     under hydrocortisone-administration and more intense under dexamethasone-administration~     comparing both to a placebo-condition. Regarding the neural activation pattern we expect~     higher activation in the hydrocortisone condition in the amygdala, the hippocampus and the~     medial prefrontal cortex compared to the placebo-condition and less activation in the~     dexamethasone-condition compared to the placebo-condition.~   "
187668|NCT01108120|"~     -  Diabetic foot ulcers (DFU) are one of the chronic consequences of diabetes which~          constitute the most important cause of non-traumatic amputation of the inferior limbs.~          Patients with diabetes are 22 times more likely to have foot ulceration or gangrene than~          nondiabetics，while foot ulceration precedes 85% of lower-extremity amputation.~        -  Three factors combine to promote tissue necrosis in diabetic feet: ischemia, neuropathy~          and trauma. Among them, ischemia peripheral arterial disease may play the important~          roles in the development of DFU. Moreover, diffuse vascular disease is the main~          characteristics, and thus it becomes difficult for treatment by using arterial bypass or~          balloon angioplasty. Therefore, we hypothesized that continuous arterial thrombolysis~          may be an effective therapy in diabetic foot. The purpose of this study is to~          investigate the effectiveness and safety of continuous intra-femoral artery injection of~          urokinase by micro-artery-pump in diabetic ulcers.~   "
187669|NCT01108107|"~     This study will investigate~        -  the effect of preoperative combination chemotherapy in patients with locally advanced~          colon cancer with mutation in the KRAS, BRAF or PIK3CA gene~        -  the effect of preoperative combination chemotherapy in combination with biological~          treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.~   "
187670|NCT01108094|"~     BCCs are the most common human cancer in the US and affect over 1 million people. There is no~     effective drug to prevent basal cell carcinomas of the skin.~      We hope to learn if an oral antifungal drug, Itraconazole, might inhibit a marker of~     proliferation and a biomarker (tumor signaling pathway) of BCC development.~      Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and~     has been used for the past 25 years with relatively few side effects. It has been shown in~     mice to reduce a BCC biomarker and to reduce growth of BCCs.~      Thus, it may reduce BCC growth in humans.~   "
187671|NCT01108081|"~     This project is investigating whether both moderate-intensity physical activity and dietary~     weight loss will independently reduce sleep apnea symptoms and improve quality of life.~   "
187672|NCT01108068|"~     This was a pilot study of 10 patients with Osteoporosis-pseudoglioma syndrome (OPPG) from the~     Old Order Mennonite community and 16 controls, who did not have OPPG. Five of the 10 OPPG~     patient elected to participate in the Lithium trial and 5 participated only in baseline data~     (labs, pQCT). The 5 with OPPG who were given lithium for 6 months had both dual energy xray~     absorptiometry (DXA), peripheral quantitative computerized tomography (pQCT) and lab~     assessment at baseline and 6 months. Studies in the mouse model of OPPG showed that lithium~     normalized their bone strength. Controls (n=16) were recruited from the Old Order Mennonite~     community, to minimize the effects of environmental and lifestyle factors. The controls were~     not be given lithium. The age range of participants was 4-64 years.~   "
187673|NCT01108055|"~     We will combine an oral investigational vascular endothelial growth factor (VEGF inhibitor)~     called pazopanib which is being studied in kidney cancer will be combined with standard~     chemotherapy called taxol in patients with relapsed recurrent urothelial cancer.~   "
187674|NCT01108042|"~     A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in~     patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the~     compatibility of the TPF-induction without decreasing the efficacy the dose will be given on~     day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks.~      In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will~     be defined.~      In the phase II-part the progression-free survival after 2 years will be assessed in patients~     treated with the optimal therapeutic dose.~   "
187675|NCT01108029|"~     Along with cognitive and psychobehavioural disorders, gait disorders represent a major~     problem in the treatment of advanced Parkinson's disease (PD). PD can be considered to be a~     hyperglutamatergic disease because dopaminergic depletion induces hyperactivity of the~     subthalamic nucleus (STN) and the internal pallidum (GPi), with glutamatergic hyperactivity~     of the STN's efferent pathway, i.e., the subthalamopallidal, subthalamonigral and~     subthalamo-entopeduncular pathways (projecting to the pedunculopontine nucleus (PPN)). Excess~     glutamate in the PPN has also been observed in the 6-OHDA rat model of PD. Reduction of this~     glutamatergic hyperactivity within the PPN via the systemic or intra-peduncular~     administration of glutamate antagonists improves akinesia in drug-induced murine and primate~     models of PD, via the NMDA and AMPA receptors. High doses of memantine (10 mg/kg) improve~     locomotion in reserpine- and alpha-methyl-p-tyrosine-treated rats. In humans, the PPN may~     play a key role in gait, posture control, axial rigidity and attention. It is also involved~     in the gating of sensory information involved in the startle reflex, which can be studied via~     prepulse inhibition (PPI) of the blink reflex. At present, two uncompetitive NMDA receptor~     antagonists are approved for use in humans: amantadine and memantine. Reviews of the recent~     literature on these drugs have identified no published studies specifically on severe gait~     and attention disorders in PD. Memantine is a partial blocker of open NMDA channels. The~     value of memantine relates to the fact that it decreases excessive glutamatergic transmission~     by lowering the synaptic noise due to excessive activation of NMDA receptors. In this~     double-blind study, the investigators shall seek to demonstrate the presence or absence of an~     effect of memantine on gait and attention disorders. In order to study the interaction~     between glutamatergic hyperactivity and the dopaminergic system, the investigators shall~     study the phenomena both in the absence of L-dopa and following acute administration of the~     latter. Twenty eight volunteer, non-demented, late-stage PD patients displaying severe gait~     disorders will receive memantine (20 mg/day) or placebo for 3 months. The investigators~     expect to see a reduction in gait and attention disorders, together with an improvement in~     the blink reflex with PPI under memantine. This pilot study could subsequently be turned into~     a double-blind, placebo-controlled multicenter study.~   "
187676|NCT01108016|"~     The study will answer two questions about women with breast cancer in rural communities:~        1. Will they find this support group format utilizing videoconferencing acceptable and~          rewarding?~        2. Will they report a greater sense of emotional and informational support, and less~          depression and traumatic stress, than the control groups of women who wait to~          participate until after the first groups have ended?~   "
187677|NCT01108003|"~     Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth~     of certain cancers.~      Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating~     patients with transitional cell bladder cancer undergoing surgery.~   "
187678|NCT01107990|"~     The investigators are beginning a clinical research study here at UCSF to learn more about~     how hearts with single ventricles work. The investigators hypothesize that myocardial strain~     , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts.~     This abnormality is associated with depressed cardiac power output and impaired exercise~     capacity. The study will utilize cardiac magnetic resonance imaging, exercise testing, and~     lung function testing to study how the single ventricle heart works so that in the future the~     investigators can improve how the investigators care for patients with this type of~     congenital heart disease.~      The research protocol involves: Cardiac magnetic resonance imaging (MRI of the heart),~     exercise tests, and lung function tests. Some of these tests are routinely used to follow~     patients with single ventricles. Some of these tests are part of the research protocol. If~     you agree to participate in this study, these tests will be performed at UCSF. The results of~     the routine tests will be shared with your doctor.~      Participation will require approximately 30 additional minutes to the cardiac MRI procedure~     to collect the research data. The exercise tests, and lung function tests time commitment~     will take about two hours.~   "
187679|NCT01107977|"~     Irritable bowel syndrome (IBS) affects as many as 14% of high school-aged students. Symptoms~     include discomfort in the abdomen, along with diarrhea and/or constipation and other~     gastroenterological symptoms, which can significantly impact quality of life and daily~     functioning of patients. Emotional stress appears to exacerbate IBS symptoms suggesting that~     mind-body interventions reducing arousal may prove beneficial. Often symptoms can be traced~     to childhood and adolescence, making the early manifestation of IBS important to understand.~     The current study focuses on young people aged 14-26 years of age with IBS. The study will~     test the potential benefits of Iyengar yoga (IY) on clinical symptoms, psychospiritual~     functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and~     spiritual benefits to practitioners and has been associated with reduced stress and pain.~     Through its focus on restoration and use of props, IY is especially designed to decrease~     arousal and promote psychospiritual resources in physically compromised individuals.~     Sixty-four IBS patients aged 14-26 will be randomly assigned to a standardized 6-week~     biweekly IY group-based program (1.5 hour sessions) or a wait-list usual care control group.~     The groups will be compared on the primary clinical outcomes of IBS symptoms, quality of life~     and global improvement at post-treatment and 2 month follow-up. Secondary outcomes will~     include visceral pain sensitivity assessed with a standardized laboratory task (water load~     task), and psychospiritual variables including coping, self-efficacy, mood, acceptance and~     mindfulness. It is hypothesized that IY will be safe and feasible: with less than 20%~     attrition; and the IY group will demonstrate significantly improved outcomes compared to~     controls, with physiological and psychospiritual mechanisms contributing to improvements;~     clinical treatment gains will be maintained at 2 months following yoga.~   "
187680|NCT01107964|"~     The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline,~     Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical~     markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with~     lissamine green, and fluorescein tear break-up time) when compared to administration of~     placebo.~   "
187681|NCT01107951|"~     The purpose of this study is to determine the response rate and response duration with the~     combination of low-dose rituximab and high-dose dexamethasone in the treatment of adult~     immune thrombocytopenic purpura.~   "
187682|NCT01107938|"~     This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to~     that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of~     GERD.~   "
187683|NCT01107925|"~     The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery~     disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose~     in higher body weight (HBW) patients.~   "
187684|NCT01107912|"~     The 5-milligram (mg) maintenance dose (MD) of prasugrel in very elderly patients with~     coronary artery disease produces a pharmacodynamic response within the same therapeutic range~     as 10-mg MD in non-elderly patients.~   "
187685|NCT01107899|"~     To investigate how platelets recover to normal function in subjects who have symptoms of a~     heart attack or unstable angina and who get a loading dose of prasugrel or clopidogrel for~     planned coronary angiography.~   "
187688|NCT01107860|"~     The primary aim of this study is to continue the investigation of cone beam computed~     tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing~     a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal~     is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic~     work-up of breast lesions.~   "
187689|NCT01107847|"~     The purpose of this study is the measurement of regional opening and closing pressures of~     lung tissue by electrical impedance tomography in lung healthy and patients with acute lung~     injury. These values might help the setting of positive endexpiratory pressure during~     artificial ventilation to avoid the cyclic opening and closing of alveoli.~   "
187690|NCT01107834|"~     HIV-uninfected children born to HIV+ women have low level heart problems at birth which may~     predispose them to heart failure, arrythmias and heart attack later in life. The impact of~     these heart problems on future heart health is unclear as it is unknown if heart problems in~     these children persist, worsen or resolve in pre-pubescence. The objective of this study is~     to characterize heart function in HIV-negative pre-pubertal children born to HIV+ women and~     exposed to HIV and HAART in utero and compare them to age and gender matched healthy children~     born to HIV-negative women. Through this objective we will determine if heart problems in~     HIV-negative children born to HIV+ women and exposed to HAART in utero persists, worsens, or~     resolves during pre-pubescence.~   "
187691|NCT01107821|"~     Negative pressure wound therapy (NPWT) has become a powerful tool in wound bed preparation of~     complex wounds and is routinely used in various disciplines, including general surgery and~     plastic surgery.~      NPWT involves the creation of a controlled subatmospheric pressure in the wound bed. The~     vacuum is generated by a pump and is distributed over the wound bed by a dressing (mostly a~     foam or gauze sponge). The therapy has several positive effects on the wound bed, such as~     improved local blood circulation, stimulation of granulation tissue formation and controlled~     evacuation of wound exudates. Standard negative pressure applied mostly varies between -120~     mmHg and -130 mmHg.A new way of applying NPWT is the Engenex™ system using the Bio-Dome™~     Wound Dressing, a specially engineered structure that forms a defined space above the surface~     of the wound. This space will maintain its size and integrity in the presence of negative~     pressure and wound fluids and thus effectively imposes strain on the underlying tissue. The~     material properties of the dressing permit moist wound healing while encouraging efficient~     removal of exudates. The contact material will not absorb fluid. It has been clinically shown~     that the Bio-Dome™ Wound Dressing is effective at growing granular tissue in the base of a~     wound at a safe low negative pressure of -75 mmHg, possibly reducing dressing ingrowth into~     the wound bed to a minimum.~      Our intention is to evaluate NPWT by means of the Engenex™ pump and Bio- Dome™ Wound Dressing~     in 15 patients. Patients with large soft tissue defects will be examined by a plastic surgeon~     and if suitable for NPWT they will be treated with the Engenex™ NPWT system.~      Before starting NPWT wounds will be evaluated and measured (length, width, depth, volume) if~     possible. Digital photos will be made and wound swabs will be taken for microbiological~     examination.Dressing changes will be performed twice weekly, on Monday and Thursday or on~     Tuesday and Friday. At each dressing change a wound will be re-evaluated and measured.~      Other parameters to be noted will be, amongst others: pain, comfort, ease of use,material~     used, time needed for dressing change, etc.~      The NPWT treatment will be carried on for maximum three weeks. During this period plastic~     surgeons will evaluate whether the wound is ready for surgical closure or not.~      If surgical closure after 3 weeks is not yet an option possibility exists that NPWT will be~     continued.~      Every wound will be followed up until complete wound healing after surgical closure.~      All patients data will be recorded, secured, evaluated and analysed for both medical~     parameters and health economic parameters.~   "
187692|NCT01107808|"~     This is a feasibility study to examine the treatment with Metformin, vitamin D with calcium~     supplement for insulin resistance in obese, black, female teens. The association of low~     vitamin D levels and decreased insulin sensitivity has been established. Thus, the specific~     aims of this study are:~      Specific aim 1: To examine the effect of an 8-week treatment with vitamin D and calcium~     supplementations on diabetes-related risk factors in obese, black, female teens.~      Hypothesis 1a: In obese, black, female teens with both insulin resistance and vitamin D~     deficiency, treatment with vitamin D and calcium supplementation will significantly improve~     measures of insulin resistance and sensitivity (as determined by the homeostatic model~     assessment for insulin resistance and whole body insulin sensitivity index measures) when~     compared to controls not receiving vitamin D and calcium.~      Hypothesis 1b: In obese, black teen females with both insulin resistance and vitamin D~     deficiency, treatment with vitamin D and calcium supplementation will significantly improve~     measures of cardiovascular disease (decreased BMI and improved triglycerides and LDL) when~     compared to controls not receiving vitamin D and calcium.~      Specific aim 2: To determine if the addition of Metformin to the 8-week treatment with~     vitamin D and calcium supplementations improves diabetes-related risk factors in obese,~     black, female teens.~      Hypothesis 2a: In obese, black, female teens with both insulin resistance and vitamin D~     deficiency, treatment with Metformin, vitamin D, and calcium supplementation will~     significantly improve measures of insulin resistance and sensitivity (as determined by the~     homeostatic model assessment for insulin resistance and whole body insulin sensitivity index~     measures) when compared to standard of care or treatment with vitamin D with calcium~     supplementation alone while controlling for dietary intake of vitamin D and calcium.~      Hypothesis 2b: In obese, black, female teens with both insulin resistance and vitamin D~     deficiency, treatment with Metformin, vitamin D, and calcium supplementation will~     significantly improve measures of cardiovascular disease risk (as determined by the decreased~     BMI, improved triglycerides and LDL) when compared to standard of care or treatment with~     vitamin D with calcium supplementation alone while controlling for dietary intake of vitamin~     D and calcium.~   "
187693|NCT01107795|"~     This is a prospective observational study that will collect outcome data for patients who~     choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea~     Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study~     only and does not provide for evaluations or treatment of OSAHS.~   "
187694|NCT01107782|"~     The purpose of this study is to determine whether sildenafil is effective and safe in the~     treatment of fetal growth restriction.~   "
187695|NCT01107769|"~     This is a single center randomized observational study that evaluates the cost benefit ratio~     between the use of two types of instrumentation in TKA: standard instrumentation vs.~     VISIONAIRE™ Patient Matched Technology. This study does not involve treatment or~     investigational products, as all components are FDA approved and are commercially available.~   "
187696|NCT01107756|"~     Primary Objective:~      To evaluate the incidence and severity of neutropenia in patients being treated for solid~     tumours with a Taxotere® based regimen when Granocyte® 34 is being used as a primary~     prophylaxis for chemotherapy-induced neutropenia.~      Secondary Objectives:~      Haematological : To evaluate the incidence and severity of febrile neutropenia (with or~     without antibiotics) and anaemia in patients being treated for solid tumors treated with a~     Taxotere based regimen when Granocyte is being used as a primary prophylaxis.~      Non-Haematological : To evaluate the incidence and severity of the following adverse events:~     asthenia, anorexia, myalgia, nail changes and oral mucositis in patients with solid tumours~     treated with a Taxotere based regimen; when Granocyte is being used as a primary prophylaxis.~   "
187697|NCT01107743|"~     In this survey, to collect the safety and efficacy information of Amlodipine /Atorvastatin~     (Caduet® Combination Tablets) in daily medical practice will be examined. In addition, the~     necessity of special Investigation and post-marketing clinical studies will be examined,~     while investigating unexpected adverse drug reactions during the survey period and~     understanding of the status of frequency of adverse drug reactions in daily medical practice.~   "
187698|NCT01107730|"~     The purpose of this study is to determine whether vitamin C is effective in the prophylaxis~     of post-operative atrial fibrillation in on-pump cardiac surgery~   "
187699|NCT01107717|"~     Type 2 diabetes is a systemic metabolic disease with significant morbidity and mortality due~     to damaging blood vessels. Increased blood sugar level is a hallmark of diabetes and is an~     contributes to the development of many of its complications. Multiple defects, e.g. impaired~     insulin secretion and impaired insulin action, contribute to the development of the disease.~     The aim of this study is to test the efficacy and durability of combination of drugs which~     correct the defects that lead to the development of diabetes on achieving adequate and~     durable control of blood sugar levels. Achieving adequate and durable control of blood sugar~     will prevent many of diabetes complications.~   "
187701|NCT01107691|"~     This study is designed to investigate the effects of two levels of resistance weight training~     on body composition, energy expenditure, and energy intake in men and women. The weight~     training will take about one hour to complete. Participants will perform the training 3 days~     per week for 9 months in a private exercise room equipped with state of the art equipment and~     a personal trainer to help guide you through the exercises.~      The project lasts 21 months total with one follow-up visit 1-year from your last training~     date. You will be required to stay in the Lawrence area and train 3 day/week over the summer~     & holidays.~   "
187702|NCT01107678|"~     There is an epidemic rise in the number of overweight and obese children. Overweight and~     obesity in children tracks into adulthood and carries elevated risk of chronic diseases such~     as seen with the metabolic syndrome (i.e., elevated glucose, hypertension, etc.). Low levels~     of PA and poor nutrition seem to be tightly linked to the increase in overweight and obesity.~     A minimal intervention that targets simple strategies for both sides of the energy balance~     equation may diminish overweight and obesity. Increasing moderate to vigorous physical~     activity and improving nutrition through snacks is a feasible, low cost strategy and can be~     disseminated nationally through the YMCA, if successful. Specifically, we expect that~     children receiving YMCA PAN will show smaller changes in BMI after 3 years of the~     intervention when compared to children not receiving YMCA PAN (i.e. standard, existing YMCA~     After School Program or YMCA standard care).~   "
187703|NCT01107665|"~     This is a Phase II single-arm, open-label, clinical trial evaluating the efficacy and safety~     of pazopanib in combination with paclitaxel as first line therapy for subjects with~     unresectable Stage III and Stage IV melanoma. Previous cytokine therapy is permitted.~     Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors~     (RECIST). Subjects who are not candidates for curative intent treatments are eligible for~     this study.~   "
187704|NCT01107639|"~     RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in~     chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. It is not yet known whether giving radiation therapy~     together with chemotherapy is more effective with or without cetuximab in treating patients~     with esophageal cancer.~      PURPOSE: This randomized phase III trial is studying giving radiation therapy together with~     chemotherapy, with or without cetuximab, followed by surgery in treating patients with~     locally advanced esophageal cancer that can be removed by surgery.~   "
187705|NCT01107626|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium~     may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not~     yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more~     effective in treating non-squamous non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium~     alone or in combination after induction therapy to see how well they work in treating~     patients with advanced non-squamous non-small cell lung cancer.~   "
187706|NCT01107613|"~     This study will enroll patients who present to Emergency Departments (EDs) and have an acute~     exacerbation of Chronic Obstructive Pulmonary Disease (COPD) at discharged in 2 Edmonton EDs.~     Patients will all be provided with evidence-based discharge (prednisone and an antibiotic)~     and will be randomized to receive enhanced education to the primary care provider or standard~     care. The investigators' goal is to determine if an opinion leaders' advice will improve~     chronic care in these patients.~   "
187707|NCT01107600|"~     The purpose of this study is to evaluate survival and success rates of dental implants placed~     with immediate loading protocol in extraction sockets. All patients were monitored for 1 year~     after implants placement.~   "
187708|NCT01107587|"~     The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals'~     liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first~     dose of vaccination.~   "
187709|NCT01107574|"~     This study assesses the benefits of intervention with gabapentin, Osteopathic Manipulative~     Medicine or both for improvement of the symptoms of Fibromyalgia. This study also seeks to~     determine whether these treatments will decrease the number and severity of tender points,~     improve structure, function and the overall pain level of each patient from the baseline of~     the study to the end. This study is designed to evaluate whether subjects subjectively~     experience an improved quality of life and increased function as a result of these~     interventions corresponding to objective improvements.~   "
187710|NCT01107561|"~     This educational study will examine two different techniques for training emergency residents~     and staff on achieving a surgical airway (called a cricothyroidotomy).~   "
187711|NCT01107548|"~     In Western Countries, stroke and dementia are the main causes of long-term disability,~     dependency, and nursing home admission. Due to demographic trends a continuous increase of~     patient numbers can be expected.~      There is growing evidence that vascular risk factors which are implicated in the etiology of~     stroke also play important etiologic roles in both vascular dementia and Alzheimer disease.~     The present project is aimed at the reduction of stroke and dementia by means of a systematic~     detection and subsequent treatment of vascular risk factors by the family doctor based on~     established guidelines.~   "
187739|NCT01107184|"~     Recent studies indicate that remote ischemic conditioning can protect the heart and other~     organs during cardiac surgery. The investigators aim to investigate whether such a stimulus~     can reduce the incidence of atrial fibrillation or other complications following coronary~     artery bypass surgery.~   "
188107|NCT01102374|"~     This study will test the role of high dose vitamin D supplementation in prevention of acute~     respiratory infection in older nursing home residents. The investigators hypothesize that~     residents on high dose vitamin D supplementation will have a lower incidence of acute~     respiratory infection that those on standard dose vitamin D supplementation.~   "
187712|NCT01107535|"~     Published data by the Organización panamericana de la Salud shows that Peru's mortality rate~     from acute respiratory infections (ARI) in infants less than one year of life is second only~     to Haiti (14,150/100,000). Government data reports shows a marked increase of RSV infections~     in Peru. Instituto Nacional de Salud (Peru's National Institute of Health) reports between~     January 1st to February 26th 2006, 62% of their positive samples corresponded to RSV.~     Epidemiological data from Lima-Peru, demonstrates that there is no specific season for RSV~     infection although some data suggest an increase in RSV activity during cold months (May to~     September; INS data). Clinical studies show that giving five doses of Synagis (palivizumab)~     resulted in serum concentrations > 30 ug/mL for >20 weeks. The aim of this post-marketing~     observational study is to determine the RSV hospitalization rate in high-risk infants who~     received Synagis (palivizumab) through the Social Security Hospitals in the context of~     routine clinical practice.~   "
187713|NCT01107522|"~     The purpose of this study is to determine the safety, tolerability, and the maximum tolerated~     dose/recommended phase II dose of carboxyamidotriazole orotate (CTO) as a single agent in~     patients with advanced or metastatic solid tumors; in combination with oral Temodar® in~     patients with glioblastoma or other recurrent malignant gliomas; or in combination with oral~     Temodar® and radiation therapy in patients with newly diagnosed glioblastoma or other~     malignant gliomas.~   "
187714|NCT01107509|"~     This study will gather data on potential biomarkers in the treatment of advanced renal cell~     carcinoma (kidney cancer) and investigate their use as indicators of disease response. The~     results could eventually enable doctors to match levels of therapy to levels of biomarker on~     an individual basis and to increase the chance of disease response in patients. This study~     will also test a new paradigm in the treatment approach of advanced kidney cancer by using~     the drug everolimus in a neo-adjuvant setting, with the overarching goal of decreasing cancer~     recurrence rates and improving patient outcomes and survival.~   "
187715|NCT01107496|"~     This will be a randomized, double-blind, placebo-controlled, parallel group, safety and~     tolerability study in adults with ADHD. The target subjects are healthy male or female adults~     aged 18 to 64 years, inclusive, with a diagnosis of ADHD. A total of fifty subjects will be~     enrolled at approximately 5 sites in the US. Subjects will be randomized (1:1) to one of two~     treatment groups, SPN-812V or placebo.~   "
187716|NCT01107483|"~     This study was designed for changes in endotoxaemia, endotoxin-binding factors, sICAM-1~     (soluble intracellular adhesion molecule-1), and cytokines during progression of chronic HBV~     infection. Patients with chronic HBV infection and healthy control are included. A limulus~     assay was used to measure plasma endotoxin level and ELISAs were used to measure the~     concentrations of interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-α~     (TNFα), sICAM-1, and soluble CD14 (sCD14).~   "
187717|NCT01107470|"~     Age-related variability of the efficacy and tolerability of alternative pituitary suppression~     regimens in follicular stimulation for assisted reproduction purposes. A randomised,~     prospective, multi-centre clinical trial~   "
187718|NCT01107457|"~     The primary purpose for this study is to help answer the following research questions~        -  The safety of ixekizumab (LY2439821) and any side effects that might be associated with~          it.~        -  Whether ixekizumab can help participants with Psoriasis.~        -  How much ixekizumab should be given to participants.~   "
187719|NCT01107444|"~     The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination~     with docetaxel compared to docetaxel alone in patients with non-small cell lung cancer who~     were previously treated with first line chemotherapy.~   "
187720|NCT01107431|"~     This study was designed to examine changes in capillary blood glucose and venous insulin~     levels after a 70 gram oral sucrose challenge with and without simultaneous consumption of a~     dietary supplement containing L-Arabinose and a patented version of chromium (LA-Cr).~   "
187721|NCT01107418|"~     This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426~     administered as 240mg tablets in previously treated patients with metastatic melanoma.~     Patients will be randomized to receive one of four dose-levels of RO5185426 [RG7204;~     PLEXXIKON; PLX4032] orally twice daily on days 1 to 15 (morning dose). Starting on day 22,~     treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until~     disease progression. Target sample size is <100 patients.~   "
187722|NCT01107405|"~     The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic~     base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention~     of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen~     Challenge model and in an environmental model during pollen season. Comparisons will be made~     following 2 weeks of dosing.~   "
187723|NCT01107392|"~     This study will evaluate the safety and efficacy of intraprostatic administration of~     botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to~     benign prostatic hyperplasia.~   "
187724|NCT01107379|"~     A prospective, multi-arm, multi-center, observational post-market study of balloon sinus~     dilatation in the physician office setting under local anesthesia to treat patients with~     chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA~     cleared for sale in the U.S.A.~   "
187725|NCT01107366|"~     To prospectively evaluate the safety and efficacy of the LUPIAE hybrid technique for the~     treatment of~        -  thoracic or thoraco-abdominal aortic aneurysms~        -  thoracic aortic type A dissections 2. to compare the safety and efficacy of the LUPIAE~          hybrid technique with historical groups (literature review, other hybrid techniques,~          LUPIAE retrospective patients)~   "
187726|NCT01107353|"~     The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg~     Capsules under fasting conditions~   "
187727|NCT01107340|"~     This is a multicentre post-marketing prospective study to evaluate performance and clinical~     outcomes of AMIIStem primary hip system.~   "
187740|NCT01107171|"~     Tang-min-ling pills are made by Chinese herbs extract, and data showed they had antidiabetic~     effects on the experimental rats and no obvious toxicity was found.This is a randomized,~     doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy~     and safety of Tang-min-ling pills in the treatment of type 2 diabetic patients and explore~     the optimal dosage of Tang-min-ling pills.~   "
187728|NCT01107327|"~     Venothromboembolic disease (VTE), which includes deep venous thrombosis (DVT) and pulmonary~     embolism (PE), is a severe health problem, effecting 1.5/1000 per year in the general~     population. In patients over 60 years of age, the incidence is 1/100 per year. Of the two~     million Americans per year who will develop VTE, one third will develop pulmonary embolism~     (PE). VTE is usually diagnosed by Doppler ultrasound or contrast venography when present in~     the extremities, VQ scan or pulmonary angiography when PE is present. However, there are many~     instances when the diagnosis of VTE by conventional modalities is limited. These include~     obesity, recent trauma or surgery, the presence of a mass, the presence of clot around~     central lines, and clot occurring in the abdomen and pelvis. Furthermore, the differentiation~     between new and old clot has evaded all diagnostic imaging modalities, and no existing~     modality allows for an accurate delineation of all sites of thrombus within the body. New~     approaches to the diagnostic imaging of VTE in complicated cases are needed. The first~     hypothesis of this project is that FDG PET/CT can be used to accurately diagnose the presence~     and extent of acute VTE, and that it will distinguish new clot from old.~      Approximately 20-25% of all new cases of venous thromboembolism occur in known cancer~     patients. The risk of VTE is 4-6 fold greater in patients with cancer as those without (8-12%~     vs. 2%, respectively, lifetime risk). In many cases, the development of VTE occurs as the~     first clinical sign of the cancer, even before it is diagnosed. Among patients presenting~     with acute VTE have no obvious cause (defined as idiopathic or unprovoked, as opposed to~     secondary VTE), the literature reports that up to 20% (range of reported incidence 7-20%)~     may ultimately prove to have cancer, depending on the series and whether the thrombosis is~     unifocal or multifocal. Despite the substantial prevalence of occult cancer in patients~     presenting with idiopathic VTE, there are no current recommendations that these patients be~     screened for the presence of cancer. The second hypothesis of the project is that FDG PET/CT~     can accurately be used to screen for the presence of cancer in patients with unprovoked~     (idiopathic) acute VTE.~      Objectives:~      There are two specific objectives to test the hypotheses associated with this project:~        1. To establish the sensitivity of FDG PET/CT in the diagnosis of acute VTE.~        2. To perform a pilot project to aid in the design of a larger trial to define the~          incidence of occult cancer in patients rigorously selected for idiopathic (unprovoked)~          VTE, and to investigate the value of FDG PET in the early detection of occult cancer in~          this population.~   "
187729|NCT01107314|"~     In this study we hope to delineate the typical vasoactive mediator response of trauma~     patients to shock. We plan to assess serum levels of vasopressin and also catecholamines,~     angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk~     populations for vasopressin deficiency.~   "
187730|NCT01107301|"~     4.4 million children and adolescents in the United States have been diagnosed with attention~     deficit hyperactivity disorder (ADHD) and more than half are treated with medication. Most~     ADHD medications are stimulants, which activate the sympathetic nervous system (SNS). SNS~     activation is closely associated with vascular functional and mechanical abnormalities.~     Therefore, ADHD medications, via instigating SNS activation and altering the hemodynamic~     profile, may have untoward effects on the vasculature and increase risk of developing~     cardiovascular disease in children and adolescents who use them.~      Our overall objective in this study is to determine whether ADHD medication use is associated~     SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents.~     We will address this objective by conducting a case-control study and obtain non-invasive~     measures of SNS activation, endothelial function, and arterial stiffness in children and~     adolescents (8-17 years old) with (using stimulant medication) and without ADHD.~   "
187731|NCT01107288|"~     The aim of this study is to investigate the effectiveness of a 6-month music-based multitask~     exercises program (Jaques-Dalcroze eurhythmics) in improving gait and balance, and reducing~     fall risk in community-dwelling older adults with an increased risk of falling.~   "
187732|NCT01107275|"~     700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to~     receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of~     0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for~     rabies virus neutralizing antibody determination on day 49. All subjects were randomized to~     receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals~     in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken~     before and after booster for up to one year.Safety and tolerability of the vaccine was~     assessed and persistence of immune response up to 1 year after the booster doses.~   "
187733|NCT01107262|"~     The highly pathogenic avian influenza (HPAI) H5N1 virus arrived in the Middle East in 2005~     and has since established itself in local domestic birds and is now considered endemic in~     several Middle Eastern countries.Few studies indicate the presence of low pathogenicity avian~     influenza (LPAI) viruses of the H9 type among Lebanese poultry and wild birds. These studies~     also provide some evidence suggesting that humans exposed to these sick birds are showing~     elevated antibody titers against these LPAI H9 viruses.~      This study will focus on the following objectives:~        -  To determine the seroprevalence of AI in poultry-exposed and non-exposed human~          populations.~        -  To identify risk factors associated with AI infections in occupationally-exposed poultry~          workers.~        -  To conduct nation-wide cross-sectional surveillance for AI viruses among domestic birds~          in low biosecurity farms and backyard flocks.~   "
187734|NCT01107249|"~     Long term follow-up of patients treated for esophageal fistulas with a newer occlusive~     self-expanding covered metal stents compared to traditional stents.~   "
187735|NCT01107236|"~     The purpose of this study is to assess the safety of IW-6118 when administered as a single~     oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an~     exploratory manner.~   "
187736|NCT01107223|"~     Respiratory tract infections are the most common indication for antibiotic prescribing in~     primary care. Several studies have shown a strong relationship between antibiotic use and~     bacterial resistance. The aim of this trial was to assess the long-term effect of a~     continuous education program on general practitioners antibiotic prescribing behaviour. 170~     physicians were included in this study. Physicians randomized in the education group attended~     a two days seminar focused on evidence-based guidelines on antibiotic use in respiratory~     tract infections. The intervention was limited at physicians level and did not target the~     patients.~   "
187737|NCT01107210|"~     This study aims to examine the evolution and determinants of physical fitness after stroke.~   "
187738|NCT01107197|"~     Pressure ulcers are frequently associated with malnutrition. Previous studies have reported~     that nutritional support can improve the healing rate of pressure ulcers but no attention has~     been clearly given to the nutritional status of the patient treated. Moreover, other~     investigators have suggested the additional healing power of some nutrients. Unfortunately,~     previous results have been unpowered by small sample size, poor monitoring of compliance to~     treatments and the confounding effect of other nutrients. The investigators aimed to test the~     effect and additional benefits of several micronutrients delivered through oral nutritional~     support on the healing rate of pressure ulcers in malnourished patients.~   "
187800|NCT01106391|"~     This study is a multi-center prospective, open label, non-randomized investigation of~     INCRAFT™ in subjects with abdominal aortic aneurysms.~      The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.~   "
187741|NCT01107158|"~     Despite the fact that a link between cholesterol and the myometrium has been clearly~     established, no study investigating aspects of cholesterol metabolism and uterine dystocia~     currently exists. This study is a pilot study whose aim is to test the hypothesis that an~     association between uterine dystocia and single-nucleotide polymorphisms (SNPs) in the genes~     coding for the LXRs.~   "
187742|NCT01107145|"~     The current treatment recommendations for P. vivax in pregnant and non-pregnant individuals~     are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent~     relapse. As primaquine can not be used in pregnant women, these women remain at risk of~     relapse. As there is increasing concern about chloroquine resistant P. vivax in this region,~     there is a need to identify alternative treatment options. The artemisinin combination~     therapies are recommended for use against P. falciparum infections in pregnant women after~     the 1st trimester; additional data are needed to support the use of these drugs against P.~     vivax.~   "
187743|NCT01107132|"~     In Type 2 Diabetes mellitus patients we will:~        1. quantify vasculopathy and blood-retinal barrier (BRB) leakage~        2. measure blood-brain barrier (BBB) permeability and neuroanatomical changes~        3. correlate BRB pathology with BBB breakdown, inflammatory markers and neuropsychiatric~          sequela~   "
187744|NCT01107119|"~     The ambition of this study is to raise the quality of care for old and chronically ill~     patients by establishing a sustainable, systematic prevention and integrated care model for~     users of home care services.~      In this cluster randomized study the intervention will be carried through in five~     municipalities and three general hospitals. The home care units in every municipality will be~     randomized to either intervention og control units.~   "
187745|NCT01107106|"~     The purpose of this observational study is to assess the safety and tolerability of ellaOne®~     in routine conditions of use for emergency contraception in postmenarcheal adolescents and~     adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.~   "
187746|NCT01107093|"~     Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered~     after the onset of the LH surge on the outcome of the leading ovary follicle:~        -  echographic follicle rupture~        -  inhibition of follicle rupture~        -  luteal phase progesterone levels~        -  anovulatory progesterone levels~   "
187747|NCT01107080|"~     The objective of the proposed research is to develop a clinical-trial-ready device and to~     evaluate its practical utility as a routinely used intra-operative tool. Our~     multidisciplinary group has previously shown that optical techniques can effectively~     discriminate between malignant and non-malignant breast tissues. The proposed technology will~     be a multi-channel optical assay device for intra-operative imaging of margins in specimens~     excised from patients undergoing breast conserving surgery (partial mastectomy) or~     mastectomy.~   "
187748|NCT01107067|"~     The purpose of this study is investigating the effect of testosterone treatment on~     paraoxonase level in male patients with hypogonadotrophic hypogonadism~   "
187749|NCT01107054|"~     A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.~   "
187750|NCT01107041|"~     Investigators are evaluating the use of phone sensor data to estimate behavior, depression~     and anxiety.~   "
187751|NCT01107028|"~     Idiopathic pulmonary fibrosis (IPF) is a devastating disease marked by progressive lung~     scarring leading to multiple life-altering sequelae. The over-arching goals of the principal~     investigator's research program are to more fully characterize these sequelae and to examine~     interventions that might improve them. The hypotheses of this particular study are that~     pulmonary rehabilitation (PR) is one such intervention, and that PR will improve the sequelae~     of dyspnea and impairments in functional capacity, cognition, mood and anxiety, fatigue, and~     quality of life (QOL) in patients with IPF.~   "
187752|NCT01107015|"~     The Mobile Diabetes Intervention Study trial is evaluating a diabetes coaching system, using~     mobile phones and patient/ physician internet portals to allow patient-specific treatment and~     communication by their primary care physician. We hypothesize that timely information~     provided to patients and their physicians can result in reduction of A1c over 1 year.~   "
187753|NCT01107002|"~     The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows~     a significant difference in implantation, clinical pregnancy, live birth, miscarriage and~     multiple pregnancy rates among women with at least two previous IVF failures~   "
187754|NCT01106989|"~     The purpose of this pilot study is to explore the potential usefulness of a heated lidocaine~     70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial~     trigger points.~   "
187755|NCT01106976|"~     The purpose of this research is to evaluate changes in cholinergic brain activity over time~     in subjects with Parkinson disease.~   "
187756|NCT01106963|"~     Anterior knee pain (AKP) is a common complication following intramedullary (IM) nailing of a~     tibial shaft fracture. The purpose of this prospective study was to determine if there is an~     association between AKP and nail position. The investigators have analyzed postoperative~     outcome results and the possible relationship between AKP according to the visual-analog~     scale (VAS) scale, and nail position marked as a distance from the tip of the nail to the~     tibial plateau (NP) and tuberositas tibiae (NT), measured postoperatively on L-L knee X-rays.~   "
187757|NCT01106950|"~     This is a phase II therapeutic study of related donor HLA-haploidentical NK-cell based~     therapy after a high dose of fludarabine/cyclophosphamide with denileukin diftitox~     preparative regimen for the treatment of poor prognosis acute myelogenous leukemia (AML).~   "
187758|NCT01106937|"~     Two studies (Gerlach et al. 2000; Gerlach et al. 2002) described the impact of factor XIII on~     the risk of prospective hemorrhage for patients undergoing craniotomy. Since then, factor~     XIII is measured and substituted in various centers. Few reports support the idea of factor~     XIII being involved in the formation of deep venous thrombosis and pulmonary embolism. In~     this prospective observational study, patients undergoing craniotomy for brain tumors or~     vascular lesions are investigated concerning the incidence of postoperative pulmonary~     embolism in respect of possible risk factors (factor XIII activity levels, standard~     coagulation parameters, tumor entity, blood loss).~   "
188541|NCT01096615|"~     The aim of the study is to show an improvement of quality of life on the 5th week of product~     consumption (probiotic Lactobacillus paracasei LP-33)(as assessed by RQLQ global score) in~     subjects with persistent allergic rhinitis currently treated with Loratadine or oral~     anti-histaminic treatment.~   "
187759|NCT01106924|"~     Probiotics administration is associated with health benefits on gut barrier integrity and~     immunological functions of the gastrointestinal tract. Recently, probiotics consumption was~     proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al.~     2009) as well as abdominal fat in human (Kadooka Y, 2010). The mechanisms explaining the~     effects of probiotics in weight control are not well understood.~      The primary objective of the clinical trial is to investigate whether a consumption of a~     probiotic formula when compared to an intake of a placebo, is associated with a greater~     reduction of body weight.~   "
187760|NCT01106911|"~     The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in~     combination with full field digital mammography (FFDM) has the potential to reduce~     significantly baseline screening recall rates without a loss in the detection of cancers. The~     primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline~     screening mammography recall rates in negative examinations by at least 20%.~   "
187761|NCT01106898|"~     This phase II trial studies the side effects and how well giving cyclophosphamide and~     paclitaxel with or without trastuzumab works in treating patients with stage I-II breast~     cancer who have undergone surgery. Drugs used in chemotherapy, such as cyclophosphamide and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving monoclonal antibody therapy, such as~     trastuzumab, with chemotherapy may kill more tumor cells. Giving these treatments after~     surgery may kill any tumor cells that remain after surgery.~   "
187762|NCT01106885|"~     Evaluation of telephone care management intervention designed to improve outcomes among~     depressed diabetes patients.~   "
187763|NCT01106872|"~     The purpose of this study is to test the combination of the chemotherapy drugs Gemcitabine,~     bevacizumab, and docetaxel with valproic acid to treat patients with metastatic sarcoma.~     Valproic acid is used by people who have seizures to prevent seizures from happening;~     however, its use in cancer is investigational. This study will help define the proper dosing~     of this valproic acid. We will assess the safety of valproic acid with the combination of the~     above chemotherapy drugs and check for possible side effects. Valproic acid may improve the~     function of the chemotherapy drugs against the cancer.~   "
187764|NCT01106859|"~     A study in healthy volunteers of the next morning driving performance after~     middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The~     next morning driving performance will be measured by taking a standardized driving test.~   "
187765|NCT01106846|"~     Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in~     opiate requirement following endometrial ablation surgery and the intraoperative~     administration of ketamine will result in a decreased time to meet discharge criteria in the~     PACU following endometrial ablation surgery.~      The research question is Does intraoperative administration of ketamine result in decreased~     postoperative opiate requirement and time to discharge from the postanesthesia recovery unit~     (PACU) following hysteroscopic endometrial ablation.~   "
187766|NCT01106833|"~     This study is designed as a combined Phase II/III, randomized, open label, multicenter,~     prospective comparative study of sirolimus plus prednisone versus~     sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients~     will be stratified by transplant center and will be randomized to an experimental arm of one~     of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of~     sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.~   "
187767|NCT01106820|"~     The purpose of this randomized intervention study is to investigate the effects and~     biological mechanisms of a supervised 12-week progressive resistance training on fatigue and~     quality of life in breast cancer patients during chemotherapy. To determine the effect of the~     exercise itself beyond potential psychosocial effects due to attention by trainers or the~     group support, patients in the control group have a comparable training schedule (i.e. 60~     min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).~   "
187768|NCT01106807|"~     The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in~     reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice~     daily applications. The study will also evaluate the safety of the study products using~     tolerance and adverse event data.~   "
187769|NCT01106794|"~     The purpose of this study is to prospectively collect specimens from pediatric patients with~     diffuse intrinsic pontine glioma or brainstem glioma, either during therapy or at autopsy, in~     order to characterize the molecular abnormalities of this tumor.~   "
187770|NCT01106781|"~     This is a descriptive observational study. The primary objective is to explore the EGFR gene~     mutation status in early stage NSCLC with adenocarcinoma histology after complete resection.~     The patients should be histological confirmed adenocarcinoma of the lung, have received~     complete resection and tested for EGFR mutation in regular medical practice.~   "
187771|NCT01106768|"~     There is little accurate data in the literature at present on oral problems of hyperactive~     children, especially regarding care needs that would justify an assumption oral specific. The~     purpose of this study is therefore to have accurate data regarding the risk of caries, other~     oral diseases like periodontal disease, trauma, and assess the needs dental care and problems~     in cooperation for dental care in a population of children and adolescents with hyperactivity~     disorder with attention deficit. Finally, it has recently been described as the sleep~     disordered breathing was not uncommon in disorder attention deficit/hyperactivity disorder,~     whether snoring and/or apnea. But it is now accepted that some features of facial morphology~     favoring pharyngeal congestion occur in individuals with obstructive sleep apnea~     (hyperdivergent typology with increased anterior facial height and decreased posterior facial~     height, becoming the facial retrognathia, pharyngeal congestion, elongation and thickening of~     the soft palate, low position of the hyoid bone). A cephalometric analysis of craniofacial~     architecture and relationships with the soft tissue surrounding skeletal structures will~     detect if any of these specific characteristics that could promote sleep disordered breathing~     are found in disorder attention deficit/hyperactivity disorder prevalence with a particular.~   "
187772|NCT01106755|"~     The aim of this study was to investigate the effects of gait training on ground level,~     combining BWS and FES in people following chronic stroke.~   "
187773|NCT01106742|"~     Based on the anti-inflammatory and stabilising effect of the AbM, (Agaricus Blazei Murill)~     based mushroom extract AndoSanTM on cytokine release in blood in vivo and ex vivo in healthy~     volunteers after 12 days consumption, the aim in this study is to investigate whether same~     effect is valid in patients with IBD (inflammatory bowel disease). In addition, calprotectin~     an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal~     inflammation will be measured in blood and feces of these patients.~   "
187774|NCT01106729|"~     This study will trace the path of a natural plant pigment, (cyanidin-3-glucoside; C3G),~     through the human body after consumption. C3G is the most abundant of the naturally occurring~     anthocyanin family of plant pigments and is responsible for the red to purple colour of many~     fruits and vegetables. Anthocyanins are promoted as being potentially beneficial to~     heart-health and also have anti-cancer properties, however little is known about how the body~     processes these compounds after they are eaten or how they are cleared from the digestive~     system. The investigators study aims to answer these questions and, in doing so, unravel how~     they may benefit everyone's health.~      In this BBSRC funded study, 8 healthy (18-45y) male participants will be recruited to a one~     day feeding study (lasting 8 hours) to establish the routes of clearance of anthocyanins from~     the body. After consent has been obtained, participants will be screened to establish their~     health (by NHS clinical staff). Eligible participants will be asked to consume a low~     anthocyanin diet for 7 days and to attend a study day at the Clinical Research & Trials Unit~     (CRTU, University of East Anglia). Participants will attend in a fasted state (at least 8h of~     water only) and will be asked to provide a urine (total morning void) and faecal (within the~     previous 72h) sample. Participants will then consume a C3G capsule and blood and breath~     samples will be collected at regular intervals after consumption (0.5, 1, 2, 4 and 6 hours).~     The capsule is roughly the size of a commercial vitamin-C tablet (500mg). Participants will~     then return in a fasted state on the following 2 mornings to provide further urine, faeces,~     breath and blood samples. Low anthocyanin meals will be provided throughout the study day and~     on the following 2 mornings. Participants will be reimbursed for their inconvenience~   "
187775|NCT01106716|"~     The purpose of this study is to determine whether KAI-1678 is effective in the treatment of~     postherpetic neuralgia pain~   "
187776|NCT01106703|"~     The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE~     in asymptomatic subjects with atopy.~   "
187777|NCT01106690|"~     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of~     canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are~     receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar)~     control.~   "
187778|NCT01106677|"~     The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared~     with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving~     treatment with metformin monotherapy (i.e., treatment with a single drug) and have inadequate~     glycemic (blood sugar) control.~   "
187779|NCT01106664|"~     The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in~     healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and~     pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of~     ONO-7746 when administered with or without a meal.~   "
187780|NCT01106651|"~     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of~     canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2~     diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.~   "
187781|NCT01106638|"~     The purpose of this study is to determine whether an intensive, eight session behavioral~     intervention is superior to standard care in achieving abstinence from cigarettes in smokers~     living with HIV/AIDS.~   "
187782|NCT01106625|"~     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of~     canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are~     receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood~     sugar) control.~   "
187783|NCT01106612|"~     The purpose of this study is to determine whether coronary artery CT scanning or nuclear~     stress testing is better at diagnosing chest pain patients with known coronary artery disease~     to select appropriate candidates for coronary catheterization and re-vascularization.~   "
187784|NCT01106599|"~     This is an open-label, multicenter, Phase I dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or~     metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation~     stage (Stage I) followed by an expansion stage (Stage II). Stage I will evaluate the safety,~     tolerability, and pharmacokinetics of increasing doses of GDC-0623 administered orally on a~     21 day on/7-day off dosing schedule.~   "
187785|NCT01106586|"~     To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing~     fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir~     disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of~     care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r +~     FTC/TDF was selected as the active comparator for this study as it is a preferred protease~     inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral~     treatment-naive adults.~   "
187786|NCT01106573|"~     Diabetes Mellitus (DM) is frequently appearing in patients with cardiovascular disease and~     these patients, as a consequence herby, has a lesser prognosis. DM is often related to~     increased arterial stiffness and hypertension. The investigators thesis is that DM and~     pre-diabetes is prevalent in patients undergoing cardiovascular surgery and to some extend is~     under-diagnosed. At the same time the investigators imagine that DM is closely related to the~     degree of arterial stiffness, and that these parameters are closely related to a new~     biochemical marker, fibulin-1.~      The investigators aim to describe the prevalence of type 2 DM and dysmetabolism in patients~     admitted to the hospital to undergo cardiovascular surgery and besides that to investigate if~     there is a connection between the degree of the dysmetabolism and arterial disease, by~     studying arterial stiffness and by measuring a new biochemical marker, fibulin-1, which the~     investigators newly have identified. The results of this project will give us a measure for~     the quantity of unknown DM in patients undergoing cardiovascular surgery and furthermore tell~     us more in terms of the connections between a newly identified plasma arterial marker,~     arterial stiffness and diabetes.~   "
187787|NCT01106560|"~     This is a single-centre, randomised, prospective clinical follow-up study to evaluate~     clinical outcome and gait analysis after total hip arthroplasty using the standard~     postero-lateral approach or the minimally invasive anterior approach.~   "
189763|NCT01080638|"~     Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours~     infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST~     elevation Myocardial infarction.~   "
187788|NCT01106547|"~     The purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given~     intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation~     after abdominal hysterectomy.Sodium Chloride is the placebo. The following parameters are~     registered:~        1. Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.~        2. The postoperative use of additional analgesics.~        3. Inflammatory parameters before and after surgery.~        4. Time until mobilization.~        5. Time until discharge.~   "
187789|NCT01106534|"~     XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives~     of this study are~        -  To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in~          real world settings, and~        -  To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT)~          initiative. This initiative is designed to evaluate the composite of all death,~          myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free~          from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and~          that have been treated with drug eluting stents (DES) and extended dual antiplatelet~          therapy.~   "
187790|NCT01106521|"~     Women found to have early stage breast cancer will have their cancer surgically removed~     followed by radiation treatment to the entire breast, five times per week for several weeks.~     The radiation treatment prevents the cancer from growing back but creates skin burns. Several~     studies have showed that it is nor necessary treating the whole breast.~      The investigators team has pioneered a new therapy realizing the permanent implantation of~     tiny radioactive seeds into the surgical cavity in a single one hour procedure under light~     anesthesia. Patients live a normal life while receiving the radiation treatment. The results~     of a first clinical trial on 67 patients shows that the treatment is well tolerate and~     efficient. The purpose of the study is to offer the treatment in several places and to~     increase the cohort of patient to 420 to capture rare complications if any.~   "
187791|NCT01106508|"~     This first-in-human dose-escalation study is to characterize the safety, tolerability,~     pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in~     patients with advanced solid tumors.~   "
187792|NCT01106495|"~     Shear stress maybe the most crucial local factor affecting atherogenesis. The present study~     investigated the effect of exposure to increased shear stress promoted by Enhanced External~     Counterpulsation (EECP) on the progression of subclinical atherosclerosis and the underlying~     inflammation- related molecular mechanisms~   "
187793|NCT01106482|"~     This study will evaluate the durability of antibody responses in children and adolescents~     after primary immunization with TBE vaccine~   "
187794|NCT01106469|"~     The purpose of this study is to investigate the safety, tolerability, food effect as well as~     the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the~     body and how it is removed from the body over time) and pharmacodynamics (the effects of the~     drug) of single and multiple ascending doses of JNJ-41443532 in healthy male participants.~   "
187795|NCT01106456|"~     American Indians and Alaska Natives (AI/ANs) have the highest smoking rates of the major~     racial/ethnic groups in the United States, approaching 40% to 50%.1-3 In addition, this~     underserved population has very low smoking cessation and abstinence rates. The~     smoking-attributable mortality rate of AI/ANs is not only the highest but double that of~     other ethnic groups.4 To date, there have been almost no studies that have focused on methods~     to encourage smoking cessation among AI/AN smokers and no randomized clinical trials. There~     is a desperate need for effective, culturally tailored cessation programs.5, 6 We propose a 2~     arm, group randomized clinical trial to be conducted at 2 sites in the Midwest (Kansas and~     Oklahoma).~      We have begun to address these issues through the creation of the All Nations Breath of~     Life (ANBL) smoking cessation program using community-based participatory research methods.~     ANBL is group-based and is culturally-sensitive in all program components. It recognizes the~     sacred role of tobacco among many AI/ANs and how culture affects smoking cessation among~     AI/AN, while still addressing recreational smoking. Our pilot work shows promise for reducing~     cigarette smoking in AI/AN smokers, with quit rates of 30% at six months post-baseline,~     compared to 8-10% quit rates in other published studies.~      All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline or~     Bupropion or NRT) then randomized into either the culturally-tailored All Nations Breath of~     Life program (ANBL) or Nontailored (NT. ANBL consists of in-person group sessions and~     individual telephone calls. We have successfully conducted a pilot study of ANBL and have~     found very promising results. At 6 months post baseline, all participants will be assessed~     for smoking status and continuous abstinence. We will randomize 28 groups per site (8 smokers~     per group) to ANBL or NT for a total sample size of 448 AI/AN smokers.~      This study is the first controlled trial to examine the efficacy of a culturally-tailored~     smoking cessation program for AI/ANs. In collaboration with AI/AN colleagues in Oklahoma we~     designed and successfully piloted the intervention to be culturally-tailored and sustainable~     in order to enhance its potential for widespread adoption and ultimate impact among AI/AN~     smokers. If the intervention is successful, the potential health impact is significant~     because the prevalence of smoking is the highest in this population.~   "
187796|NCT01106443|"~     When a patient presents with a thyroid mass, part of the work-up may include a fine needle~     aspiration biopsy (FNAB). The results of the biopsy then help plan treatment. If the results~     are benign, the management will typically be to follow the nodule. If the results demonstrate~     or are suspicious for cancer, such as papillary thyroid carcinoma (PTC), the treatment is a~     total thyroidectomy (total thyroid removal). The latest American thyroid association~     guidelines for PTC (2009) suggest that in many instances a central lymph node dissection~     (CLND) should be performed in conjunction with the total thyroidectomy. This procedure~     consists of removing the lymphatic (glandular) tissues surrounding the thyroid itself, as~     this tissue may have a propensity for cancer spread. The procedure's necessity has met much~     controversy in the last decade, but is becoming more of a standard in thyroid cancer surgery.~      When a thyroid nodule FNAB is reported as indeterminate, the treatment strategy is less clear~     cut. While a diagnostic hemi-thyroidectomy or therapeutic total thyroidectomy may be in~     order, the inclusion of CLND is not clearly defined. In many centers a CLND will be omitted~     with surgical management for an indeterminate lesion, while in others, it is standard~     protocol. The argument of performing CLND is largely based on the tenet that it adds little~     surgical time, cost or risks to the patient. Because the evidence of the prognostic role of~     lymph node metastases is limited many would argue that the risk of not performing CLND is~     greater than performing CLND. Furthermore, in the event of finding cancer on final pathology,~     and thus, having to re-operate in the thyroid/central compartment bed, post-operative~     complications may increase. Opponents of CLND argue that there is a paucity of strong~     evidence supporting CLND in the improvement of oncologic outcomes and can potentially~     increase post-operative low calcium levels or vocal nerve damage However, these~     recommendations are based on retrospective level III evidence. Thus the debate continues: is~     CLND justified as an adjunct to hemi-or total thyroidectomy in indeterminate thyroid~     pathology?~      The hypothesis is: CLND in hem- or total thyroidectomy for indeterminate thyroid nodules~     will not increase post-operative complications.~   "
187797|NCT01106430|"~     This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are~     judged by the Investigator to have had an inadequate response to methylphenidate therapy. The~     study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.~   "
187798|NCT01106417|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in~     subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical~     vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level~     anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation.~   "
187799|NCT01106404|"~     The purpose of the study is to gather clinical information on subjects' experiences with and~     without the use of the new feature of the RestoreSensor implantable neurostimulator (INS).~   "
187801|NCT01106378|"~     The purpose of this registry is to compare the safety and the performance of the NEVO™~     Sirolimus-eluting Coronary Stent, once commercially available, to the CYPHER Select® Plus~     Sirolimus-eluting Coronary Stent in complex subjects presenting with acute STEMI for primary~     intervention, diabetes mellitus or multi vessel disease. The second purpose of this registry~     is to evaluate the safety and performance of the NEVO™ Sirolimus-eluting Coronary Stent, once~     commercially available and the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in~     complex subjects diagnosed with acute STEMI for primary intervention, diabetes mellitus~     and/or multi vessel disease.~      The data will be collected from subjects treated with commercially available product and~     following routine clinical practice. Uniform, complete and accurate data will be collected on~     the subject's medical history, peri-procedurally, during the index hospitalization, and~     during follow-up.~   "
187802|NCT01106365|"~     Multiple sclerosis (MS) is a chronic-inflammatory autoimmune central nervous system disorder~     and a leading cause of neurological disability in younger adults in Western countries.~     Besides classic neurological symptoms both depressivity and fatigue are among the most~     frequent symptoms in MS, affecting up to 90% of patients at onset or during the course of the~     disease. Neither are the psychological and immunological backgrounds of both well understood,~     nor are there numerous controlled therapeutic trials which would offer convincing treatment~     options for fatigue and depressivity in MS.~      Transcranial magnetic stimulation (TMS) has been frequently used to investigate altered~     hemispheric and inter-hemispheric connectivity in MS. Recently, first therapeutic trials have~     been performed to address specific MS-related symptoms by TMS. Koch et al. demonstrated an~     improvement of hand dexterity following repetitive TMS, and Centonze and colleagues showed~     reduced spasticity following TMS.~      Recently, a specific coil for the stimulation of deeper brain regions including the deep~     nuclei was developed, the so-called H-coil. It successfully stimulates deeper (pre-frontal)~     brain regions. Stimulation with this coil has been shown to be safe and well tolerated in~     healthy volunteers, and in patients suffering from major depression.~      The aim of this project is to apply deep TMS with the H-coil to the prefrontal cortex (PFC)~     of MS patients. The PFC is the region at which stimulation is aimed in previous depression~     studies as this brain region has been shown to play a relevant role in affective disorders.~     It is the primary aim of this study, to evaluate the safety and tolerability of deep TMS with~     the H-coil in MS patients with fatigue or depressivity.~   "
187803|NCT01106352|"~     The main purpose of this study is to establish a recommended dose of Alpharadin to be used in~     combination with docetaxel in patients with bone metastases from castration-resistant~     prostate cancer and to investigate safety and explore efficacy of the recommended dose.~   "
187804|NCT01106339|"~     The purpose of this study is to define subgroups of patients with somatoform disorders due to~     DSM-IV by immunological, psychological and genetic characterization.~   "
187805|NCT01106326|"~     The goal of this pilot study is to implement directly observed therapy with preventive asthma~     medications through a partnership with the school nurse (with input and direction from the~     primary care provider) to assure that the teen receives guideline based preventive~     medications, and provide a motivational interviewing intervention to help the teen transition~     to independence with their medical treatment plan. We hypothesize that this community-based~     pilot intervention will; 1) be feasible and acceptable among this population and among school~     personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and~     emergency room / urgent care use for asthma care). We anticipate that enhancing preventive~     healthcare for urban teens with asthma through partnerships with schools will yield improved~     health, prevention of suffering, decreased absenteeism from school, and reduced healthcare~     costs. This new method of preventive care delivery could be sustained within the school~     nursing system, and could be implemented in schools nationwide. Further, it could be applied~     to other chronic illnesses affecting disadvantaged populations.~   "
187806|NCT01106313|"~     The purpose of this study is to study the relationship between insulin and glucose action and~     neuropsychological functioning (memory, attention, general thinking abilities) in persons~     with depression.~   "
187807|NCT01106300|"~     Each year, 110,000 English/Welsh patients are admitted to Intensive Care Units (ICU). Many~     face prolonged disability as a result. Over two thirds have moderate-extreme limitation in~     their usual activity a year later, and one-third are severely affected, being unable to~     continue most activities, or to live independently. Quite why known- but severe muscle~     wasting isn't may play an important role. We hope to find out, measuring the degree of~     wasting in patients, and seeking potential causes. We shall also address the mechanism of~     wasting, which may reflect an altered balance of activity in muscle growth pathways and those~     that break muscle down. We'll do this by collecting data, taking regular blood tests,~     scanning the leg muscles with an ultrasound machine, and analysing small muscle samples. In~     addition, we'll accurately and objectively measure how impaired these patients become, using~     specialist questionnaires, special monitoring equipment, simple walking tests and occasional~     special ('Cardio-Pulmonary') exercise tests. We'll try to see how badly activity is limited,~     and tease out whether muscle weakness plays a significant role in this. Finally, keeping~     muscles working (hard to do when unconscious/drowsy/bed-bound) may maintain muscle mass, so~     we'll see whether maintaining muscle activity using painless electrical stimulation will~     help.~   "
187808|NCT01106287|"~     This study will evaluate the safety and tolerability of single doses of MK-0941 based on~     assessment of clinical and laboratory adverse experiences~   "
187809|NCT01106274|"~     Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown~     potential to improve the signs and symptoms of bullous keratopathy .The objective of this~     study is to demonstrate the effects of C3R to treat bullous keratopathy.~   "
187820|NCT01106118|"~     The primary goal of this international non-interventional study is to investigate the~     therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients~     with the Metabolic Syndrome in daily clinical practice. It will include a large number of~     patients with various underlying conditions with different cultural and demographic~     backgrounds from different geographic areas.~   "
187821|NCT01106105|"~     The goal of the present study was to objectively evaluate the postural behaviour of type II~     obese patients as compared to adults showing a normal body mass index (BMI) in critical~     postural tasks.~   "
187810|NCT01106261|"~     Patients who have been treated successfully for bowel cancer (colorectal cancer) sometimes go~     on to develop nodules of disease in another part of the body. If this disease is found to be~     related to the original cancer it is called a metastasis. Some patients develop one or more~     metastases particularly in the lungs or the liver.~      There is a growing trend to remove lung metastases with an operation, in the belief that this~     will help patients live longer, however there have not been any scientific studies to prove~     this. There is also very little published information about the side effects of this surgery~     and how it affects subsequent daily living. This is a feasibility study to determine whether~     it will be possible to conduct a large randomised controlled trial investigating the value of~     pulmonary metastasectomy (surgery to remove lung metastases) in patients who have been~     successfully treated for colorectal cancer. There is a two stage consent and randomisation~     process. Firstly, patients will be invited to consent to having a full range of~     investigations to assess their suitability for surgery. If found to be suitable, they will~     then be invited to consent to randomisation between active monitoring of their disease or~     active monitoring with pulmonary metastasectomy. Patients will be followed up regularly for 5~     years to assess their disease status and to measure their quality of life and lung function.~   "
187811|NCT01106248|"~     The purpose of this study is to assess whether eribulin mesylate (E7389) has an impact on the~     electrocardiogram (ECG) with focus on cardiac repolarization, as measured by QT/QTc interval~     as well as through a pharmacokinetic-pharmacodynamic (PK/PD) analysis.~   "
187812|NCT01106235|"~     RATIONALE: Aldesleukin may stimulate lymphocytes to kill melanoma cells. Treating lymphocytes~     with interleukin-21 in the laboratory may help the lymphocytes kill more tumor cells when~     they are put back in the body. Giving therapeutic autologous lymphocytes together with~     cyclophosphamide and aldesleukin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of giving therapeutic~     autologous lymphocytes together with cyclophosphamide and aldesleukin in treating patients~     with metastatic melanoma~   "
187813|NCT01106209|"~     The purpose of this study is to characterize the time to maturation of neutrophil~     extracellular trap(NET) formation capability in polymorphonuclear leukocytes(PMNs) isolated~     from newborn premature and term infants as well as infants <1 year of age undergoing elective~     surgery. This study will also determine whether NETs contribute to the pathogenesis of~     necrotizing enterocolitis (NEC). We hypothesize that NET formation contributes to the~     pathogenesis of NEC by inappropriately releasing degradative proteins and tissue destructive~     enzymes into the inflammatory milieu of the premature infant gastrointestinal tract following~     bacterial translocation. We also hypothesize that the delay in NEC development in premature~     infants (3rd - 4th week of life) as compared to at-risk term infants (1st week of life)~     results from a developmental delay in PMN ability to form NETs.~   "
187814|NCT01106196|"~     The purpose of this study is to examine the incidence of acute myocardial infarction (MI)~     occurring after an influenza-like illness using linked primary care and disease registry~     databases.~   "
187815|NCT01106183|"~     The goals of our study are to critically evaluate if a healthy population supplemented with~     Transfer factor experiences fewer incidences of colds and flu, or experience shorter duration~     of illness compared to an identical population taking placebo. In this study we will give~     either Transfer factor or a placebo to two groups of healthy adult men and women for a period~     of 7 weeks in a double-blind experimental design. The frequency and duration of colds and~     flu-like symptoms will be recorded during the course of the study. Saliva samples will be~     collected weekly and assessed for salivary IgA secretion rate. Data from this study will~     establish the efficacy of Transfer Factor to support a healthy immune system.~   "
187816|NCT01106170|"~     The purpose of this study is to determine if a supplement called Provex CV can reduce blood~     pressure and other risk factors for heart disease. Heart disease is the leading cause of~     death in this country and it is important to identify dietary factors, including supplements,~     that can reduce heart disease risk factors. The supplement to be tested in this study is made~     of a combination of natural compounds found in plants such as grapeseed extract, green tea,~     and quercetin. Each compound individually has been shown to improve blood pressure or reduce~     inflammation. We hypothesize that Provex CV will reduce blood pressure and levels of~     inflammatory cytokines hypertensive patients with symptoms of metabolic syndrome. This~     investigational trial of Provex CV has been approved by the United States Food and Drug~     Administration.~   "
187817|NCT01106157|"~     The primary purpose of this study is to determine if giving the combination therapy~     consisting of Thymoglobulin® (ATG) and Neulasta® (GCSF) to patients with established Type 1~     Diabetes (T1D) is safe and secondarily, if the ATG and GCSF will preserve insulin production.~   "
187818|NCT01106144|"~     The main component in the treatment of acute myeloid leukemia (AML) is consist of~     anthracycline (such as daunorubicin or idarubicin) and cytarabine. Inter-individual~     variability of transport/metabolism of the chemotherapeutic agent and several genetic~     pathways involved in the drug action might be associated with different response following~     the treatment for AML usually consisted of chemotherapy and/or transplantation. One of~     potential pathways involved in the drug action is DNA repair pathway, accordingly single~     nucleotide polymorphisms (SNPs) in the DNA repair machinery pathway might be a predictive~     marker for therapy outcomes in AML.~      Several genes were involved in the DNA repair machinery which are 1) Nonhomologous end~     joining (NHEJ) pathway involved in the G1/S phase, 2) Homologous recombinational repair (HRR)~     pathway involved in the S/G2 phase. XRCC4, LIG4, MRN and ATM are well known genes involved in~     the NHEJ pathway, while MRE11, RAD50, NBS1 (MRN), RAD51, XRCC2, XRCC3, RAD51B, RAD51C, RAD~     51D, RAD52 or RAD54 are known to be associated with HRR pathway.~      A study suggested that the SNPs in the DNA repair pathway was involved in the susceptibility~     of secondary AML developing after chemotherapy or autologous hematopoietic stem cell~     transplantation, thus these SNP markers could become a predictive marker for secondary AML.~     However, it has never been investigated for multiple candidate pathways simultaneously with~     relateively larger number of patients. Accordingly, the current study attempts to investigate~     the potential role of the genotype markers in multiple candidate pathways, esp. focused on~     the DNA repair machinery, with respect to response following chemotherapy or survival of AML~     patients.~      Total of over 500 archived samples from the patients diagnosed as acute myeloid leukemia at~     the Samsung Medical Center, Seoul, Korea will be included, and genomic DNAs will be extracted~     and will be examined for their genotypes of the candidate SNPs involved in the DNA repair~     pathways. Then statistical analysis will be pursued for single marker analysis, haplotype~     analysis and for the construction of genetic risk model based on the multivariate analysis.~   "
187819|NCT01106131|"~     The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin~     combination treatment group is non inferiority compare to pioglitazone and metformin~     combination.~   "
187822|NCT01106092|"~     The purpose of the study is to assess the immunogenicity and safety of three formulations of~     GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines~     administered concomitantly, when administered as a single booster dose to healthy~     poliovirus-primed toddlers aged 12-24 months.~   "
187823|NCT01106079|"~     The purpose of this study is to investigate whether tight control of patients with newly~     diagnosed psoriatic arthritis (consisting of regular 4 weekly objective assessment of disease~     activity and protocol-led intensive treatment) can improve outcome as opposed to standard~     care (usually 3 monthly reviews with no objective outcome measures and no protocol for~     treatment). The principle hypothesis of this study is that tight control of inflammation in~     psoriatic arthritis using a treatment protocol and pre-defined objective targets for~     treatment will lead to an improvement in patients' disease activity and a reduction in~     radiological joint damage.~   "
187824|NCT01106066|"~     To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric~     cancer~   "
187825|NCT01106053|"~     This study is being conducted to evaluate the effects that the drug pramipexole has on mood,~     food craving, and other behaviors that may be related to binge eating disorder.~   "
187826|NCT01106040|"~     Data from this pivotal clinical trial will be used to support a marketing application (i.e.,~     NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in~     the lymphatic pathway draining the primary site of a tumor.~      Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in~     the detection of excised lymph nodes in patients with known melanoma and breast cancer. All~     patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc~     99m and vital blue dye.~   "
187827|NCT01106027|"~     The purpose of this study is to test whether a dosing regimen of eculizumab in addition to~     standard posttransplant care in positive crossmatch deceased donor kidney transplant~     recipients will reduce the incidence of acute humoral rejection (AHR).~      Patients included in this study will be those who have demonstrable anti-human leukocyte~     antigen (HLA) antibody specific for their deceased donor. It is our hypothesis that blockade~     of terminal complement activation with eculizumab at the time of transplant in combination~     with our current protocols will reduce the incidence of AHR in recipients of deceased donor~     kidney transplants who have anti-donor HLA antibody~   "
187828|NCT01106014|"~     The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of~     selexipag on time to first morbidity or mortality event in patients with pulmonary arterial~     hypertension.~   "
187829|NCT01106001|"~     The hypothesis of this study is that isolated use of local periarticular levobupivicaine~     injection during primary hip arthroplasty would improve post-operative pain control. Patients~     were randomised in the operating room to receive either a periarticular infiltration, or a~     placebo consisting of Saline. Morphine and analgesic consumption was recorded for each~     patient, while the modified McGill pain scale was used to determine the adequacy of analgesia~     and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45~     patients in the treatment group and 46 controls. The results were assessed after one year,~     once all the information from both treatment groups was collected.~   "
187830|NCT01105988|"~     A standard treatment for glioblastoma is a combination of radiation and the drug~     temozolomide. This combination sometimes causing swelling (inflammation) of the brain tissue.~     When standard monitoring with MRI or CT scans is done within a few months of finishing~     treatment, it may be hard to tell if the scans are showing post-treatment brain inflammation~     or tumor growth and worsening of disease. Currently the only way to definitively distinguish~     inflammation from tumor growth is biopsy.~      However, biopsy is an invasive procedure that is associated with risks. Having a non-invasive~     method to distinguish post-treatment inflammation from tumor growth can help improve care for~     patients with glioma.~      For the PET scans in this research study, the investigators are using a radioactive substance~     called FLT (3'-deoxy-3'-[F-18] fluorothymidine), instead of the standard substance FDG~     (fluorodeoxyglucose). FLT gets absorbed by cancer cells but not by areas of inflammation.~     Because of that FLT may be better than FDG in differentiating cancer cells from inflammation.~      An MRI scan will also be done at the same time as each of the 2 FLT-PET scans done for this~     research study. The two MRI scans performed will also help give more information about the~     patient's tumor that is not routinely provided with a routine clinical scan, such as blood~     flow through the tumor or metabolic activity in the tumor. The information from these special~     MRI scans may provide more information about the blood supply to the tumor and how this~     changes in response to treatment. In addition, the MRI scans along with the FLT-PET scans may~     help how to distinguish inflammation due to radiation therapy from tumor growth.~   "
187831|NCT01105975|"~     The primary purpose of your participation in this study is to help answer the following~     research question(s)~        -  Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or~          rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the~          blood fat profile more than statins alone.~        -  Whether LY2484595 alone improves blood fats profile compared to sugar pills.~        -  Whether LY2484595 interferes with break down or functioning of statins.~        -  Whether LY2484595 has any side effects that would not support testing it in future~          studies.~   "
187832|NCT01105962|"~     This is an observational research study whose purposes are to see:~        1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or~          80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic~          Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).~        2. if improvements or worsening of symptoms can be recorded with computerized and written~          tests for memory and thinking, and with questionnaires about the subject's quality of~          life and health.~        3. determine the long-term outcome of the treatment.~        4. confirm, in large numbers of study participants at multiple sites nationwide, the strong~          positive results obtained in pilot studies~   "
187833|NCT01105949|"~     The results of this study will help in the development of a new type of nasal strip for~     management of nasal congestion and snoring.~   "
187834|NCT01105936|"~     Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA~     knee following treatment with four consecutive doses (at 8 hour intervals) on giving~     sustained released paracetamol treatment or placebo will be compared. The fMRI and pain~     assessments will occur approximately 2-5 hours after taking the final dose.~   "
187868|NCT01105494|"~     This multicenter, prospective, observational study will evaluate the quality of life and the~     factors that influence the quality of life of epoetin beta [Neorecormon] in patients with~     renal chronic anemia, who are on dialysis. For each eligible patient data will be collected~     for 6 months. Target sample size is 5000-7000 patients.~   "
187835|NCT01105923|"~     The aim of this study is to identify patients with problem list gaps and intervene to correct~     these gaps by creating clinical decision support interventions that alert providers to likely~     problem list gaps and offer clinicians the opportunity to correct them. The investigators~     will randomize the clinics that will receive the intervention and formally evaluate the study~     after a period of 6 months for improved problem list completeness to determine the~     effectiveness of our intervention.~   "
187836|NCT01105910|"~     To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.~   "
187837|NCT01105897|"~     The aim of this study is to examine the incidence of deeply infiltrating endometriotic~     lesions among surgically treated endometriosis patients, and examine the impact of~     endometriosis, and its surgical treatment, on severity of pain symptoms, quality of life, and~     sexual functioning.~   "
187838|NCT01105884|"~     The purpose of the study is to evaluate the efficacy and safety of different commonly used~     dressings for treating diabetic foot ulcers. It is a prospective study recruiting 50 type 2~     diabetic patients with diabetic foot ulcers (2-50cm2). All the patients will give written~     informed consent prior to getting enrolled in the study. All the patients will be randomly~     assigned to one of the five groups of the study namely, saline (control),Biatin Ag (Foam),~     Hydrocolloid, Hydrogel and Ceredak. Follow up of the patients will be done until the complete~     healing of the wound takes place. All procedures of dressing will be done by an authorized~     and certified Podiatric Surgeon of the Institution. Details on the cost incurred and days~     required for the wound to completely heal will be recorded for all the patients.~      This study will provide the efficacy of all the dressings used for treating diabetic foot~     ulcers and also the cost of each dressing. This will help the surgeons for managing the~     diabetic foot ulcers in a better and cost effective way, which in turn will reduce the burden~     of patients both physically and financially.~   "
187839|NCT01105871|"~     This study is designed to test a specific hypothesis exploring the neurophysiologic~     mechanism(s) that underlie the pain- relieving effects of immersive Virtual Reality (VR) as a~     non-pharmacologic pain management technique, using healthy volunteers experiencing carefully~     controlled thermal and/or electrical pain in the laboratory. Over the past decade, our~     research group has performed a series of NIH-funded investigations of VR analgesia - in both~     the clinical pain and laboratory pain settings - demonstrating its clinical efficacy and~     safety. In the current study we will test pharmacologic manipulation of VR analgesia (with~     the opioid analgesia antagonist naloxone). We anticipate that this theoretical work will~     provide a foundation for future clinical applications of immersive VR - whether used alone or~     in combination with other analgesic agents - and make immersive VR a more effective and more~     widely used analgesic tool for the treatment of clinical pain.~      Our previous work with immersive VR indicates that its use during a painful event can reduce~     subjective pain reports during both acute clinical and laboratory pain by 20-50% [1].~     Furthermore, we have shown that effective VR analgesia is associated with reduced~     pain-related brain activity that is quantitatively and qualitatively comparable to clinically~     relevant doses of systemic opioid analgesics [2]. The laboratory pain protocol proposed in~     the current application is identical to the UW HSD-approved protocol used in our previous~     studies (#25296 - Reducing Brief Thermal and Electrical Pain). What is specifically~     different in the current protocol is the use of naloxone to determine whether VR analgesia~     operates through an endogenous opioid-dependent mechanism or not. The results of this study~     will not only suggest the mechanism of action of VR analgesia, but also allow us to more~     effectively apply immersive VR analgesia in the clinically pain setting through its~     thoughtful combination with well-established pharmacologic analgesic techniques, such as~     opioid analgesia administration.~      The specific aim of this study and the hypothesis it tests are as follows: To determine the~     extent to which subjective analgesic effects of VR analgesia are inhibited by opioid receptor~     antagonism with naloxone. Hypothesis - VR analgesia will not be inhibited by systemic opioid~     receptor antagonism, suggesting that VR analgesia is not mediated by release of endogenous~     opiates and/or by activation of opioid-dependent descending central nervous system pathways.~   "
187840|NCT01105858|"~     Background:~      - Family and twin studies have suggested that genetic factors influence approximately 50~     percent of a person's susceptibility to type 2 diabetes. Recently, some of the genes involved~     in the development of type 2 diabetes have been identified, in large part by genome-wide~     association studies. Certain risk factors for type 2 diabetes, such as obesity and insulin~     resistance, are highly inheritable, as are diabetic complications such as diabetes-related~     eye and kidney disorders. However, few genes associated or linked with diabetes risk factors~     or complications have been conclusively identified, and more research is needed to study~     specific genetic factors associated with these aspects of diabetes.~      Objectives:~      - To identify and characterize genetic variants associated with type 2 diabetes, its risk~     factors, and its complications.~      Eligibility:~      - Individuals at least 18 years of age who are not pregnant or nursing mothers at the start~     of the study.~      Design:~        -  All participants will provide information about family history, ethnicity and ethnic~          background, occupation, behavioral risk factors, and other data as requested by the~          researchers.~        -  In addition to a general health history, participants will provide specific information~          about diabetes history, with particular emphasis on date of diagnosis, symptoms,~          initiation of insulin therapy, complications, and current medications.~        -  Testing procedures will be different for individuals with and without diabetes. Those~          without diabetes will have an oral glucose tolerance test, while those with diabetes~          will be examined for diabetic complications.~        -  Other tests during the study will include the following:~        -  Physical examination with measurements of height and weight, waist circumference, blood~          pressure, and other tests for individuals who have been diagnosed with diabetes~        -  Glucose tolerance test for those who have not been classified as having diabetes~        -  Retinal photographs~        -  Electrocardiograms~        -  Hepatic Ultrasound~        -  Blood and urine tests~        -  Depending on the results of the examination and laboratory findings, participants may be~          asked to return to the clinic for supplemental interviews, physical examinations, or~          blood tests, or to arrange referrals for medical evaluation and treatment.~        -  Participants who have diabetes will be asked to return for yearly follow-up visits.~          Participants who do not have diabetes at the initial examination will be asked to return~          for follow-up visits every 2 years.~   "
187841|NCT01105845|"~     Background:~      - New studies in human genetics have revealed information about genetic connections to memory~     and motor behavior. Researchers are interested in investigating the role of genetics in motor~     learning, in conjunction with related studies taking place in the Human Motor Control Section~     of the National Institute of Neurological Diseases and Stroke (NINDS). Participants in motor~     learning studies conducted at NINDS will be asked to provide blood samples for further~     evaluation.~      Objectives:~      - To create a repository of blood samples from patients and healthy subjects who are~     participating in NINDS motor learning studies.~      Eligibility:~      - Individuals between 18 and 100 years of age who are or will be participating in motor~     learning research studies at the National Institutes of Health.~      Design:~        -  Blood draws for genetic testing will usually be done on the same day as the motor~          learning study. Participants will provide one blood sample for research.~        -  No treatment will be provided under this study....~   "
187842|NCT01105832|"~     40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to~     standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4~     weeks. Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The~     Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual~     analoge scale (VAS).~      Two doctors, blinded to the treatment, will judge the callus formation and healing on the~     x-rays and guess the treatment. The DASH score and the pain score will be compared between~     the treatment groups.~      The investigators hypotheses are that callus formation and healing will be more pronounced~     and that patients have less pain and better function in the rhPTH 1-34 group.~   "
189323|NCT01086397|"~     The main purpose of this study is to use an investigational urine assay to estimate the~     proportion of pneumonia in adults 50 years or older in different areas throughout the US that~     is caused by certain types of the bacteria Streptococcus pneumoniae (also called~     pneumococcus).~   "
187843|NCT01105819|"~     Critically ill patients often need ventilatory support through a plastic tube connected to a~     ventilator. Those patients have a altered microbiological flora in the mouth, oropharynx as~     well as throughout the intestine. Bacteria that can cause illness are often found in the~     oropharynx in such patients and measures are taken in order to reduce the risk of secondary~     infections by those bacteria. In all intensive care patients oral care is provided by the~     nursing staff aiming at a reduction of the pathogenic species. This is done by a variety~     measures.~      Chlorhexidine (CHX) is an antisepticum with a capability to reduce bacterial counts in the~     mouth and oropharynx and has been shown to be of value also for intubated patients. It is~     used frequently throughout the world.~      Ventilator-associated pneumonia (VAP) is a costly rather frequent complication to intensive~     care and mechanical ventilation and is usually caused by aspiration of infected secretions~     from the oropharynx. CHX has in some studies been shown to reduce the frequency of VAP.~      The probiotic bacterium Lactobacillus plantarum 299 has the ability to adhere to the mucosa~     throughout the gastro-intestinal tract including the mouth and in our pilot study we found~     that L plantarum had better ability to reduce colonisation with enteric bacteria in the~     oropharynx than CHX had. Figures not statistical significant so this present study is aiming~     to get a larger amount of data.~      The procedure was found to be safe Hypothesis: Lactobacillus plantarum is better than CHX for~     the reduction of pathogenic bacteria in the oropharynx in intubated mechanically ventilated~     patients and consequently has a better potential to reduce the frequency of VAP~   "
187844|NCT01105806|"~     Advance care planning involves thinking about choices if the patient becomes sick, and is~     important for everyone. It does not matter if the patients are ill or healthy. It is~     especially important for people who have diseases that cannot be cured. It allows people to~     make sure their wishes are respected if they become very sick or are dying. Thinking about~     these issues can be upsetting. But, for many people, it is helpful. This type of discussion~     can help the family learn what the patient may want but cannot tell them when these decisions~     need to be made~   "
187845|NCT01105793|"~     The purpose of this study is to determine the safety of topical FP1198 for the treatment of~     moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity~     of FP1198.~   "
187846|NCT01105780|"~     The purpose of this study is to assess the safety, tolerability pharmacokinetics (how the~     drug is absorbed in the body, how it is distributed within the body and how it is removed~     from the body over time) and pharmacodynamics (the effects of the drug) of JNJ-41443532 in~     healthy male and female Caucasian and male Japanese participants.~   "
187847|NCT01105767|"~     This cluster-randomized prospective study will evaluate the effect of hygiene-based~     intervention strategies on the incidence of overall SSTI and MRSA-associated SSTI among~     military trainees. The proposed interventions used singly or in combination include~     standardized training and education, and weekly chlorhexidine showers.~   "
187848|NCT01105754|"~     The overall goal of this project is to evaluate whether a multifaceted prompting~     intervention, administered in the urban primary care office setting, reduces morbidity among~     urban children with asthma. This study builds on our experience with a pilot study in two~     urban continuity clinics, in which we found that prompting clinicians about asthma severity~     and care guidelines at the time of an office visit resulted in improved preventive care~     delivery to inner-city children. This type of prompting program has the potential to~     substantially improve care for impoverished children with asthma, and we propose to~     establish: 1) whether these findings can be replicated in a similar study including a larger~     sample of urban children from different types of practices, and 2) whether the positive~     effects can be enhanced by more specific prompting directed towards both the provider and the~     caregiver and by providing practice-level supports and feedback. We hypothesize that children~     receiving a multifaceted prompting intervention (MPI) will experience less asthma-related~     morbidity (defined by symptom-free days at the 2-month follow-up) compared to children~     receiving usual care. Our secondary hypothesis is that children receiving the MPI will~     receive improved preventive asthma care (defined by guideline-based corrective actions taken~     at the index visit) compared to children receiving usual care.~   "
187849|NCT01105741|"~     Background and Rationale: Inflammatory bowel disease (IBD) is a major burden to individuals~     and society. Ulcerative colitis and Crohn's disease (CD) are the 2 major inflammatory bowel~     diseases (IBD). They share some pathologic and clinical features but overall their~     pathogenesis is not resolved and diagnosis is sometimes difficult. The incidence rates range~     from 3.1 to 14.6 cases per 100,000 person year for Crohn's disease to 2.2 to 14.3 cases per~     100,000 person years for ulcerative colitis and prevalence ranges up to 201/100,000 for~     Crohn's disease and up to 246/100,000 persons for ulcerative colitis.~      Powerful biological therapies were recently introduced for the treatment of CD. They offer~     superior treatment for the treatment of steroid refractory patients. Interestingly newer~     studies suggest that these therapies might also be beneficial if not superior if used at~     earlier stages of the disease. But presently limitations of these treatments need to be~     considered and biomarkers that could better direct these treatments are urgently needed.~      One present limitation is that these new therapies, though being beneficial in a large number~     of CD patients, will not be beneficial to all CD patients. Presently treatment responders and~     non-responders can not be identified prior to the treatment with the biological adalimumab~     representing an important unmet clinical need. Since adalimumab treatment can be accompanied~     by serious, potentially lethal, side effects, it would be a major advantage if future~     biomarkers could predict whether an individual will or will not respond to one or the other~     treatment.~      Furthermore with treatments available being associated with high costs to patients and~     society, as the treatment with adalimumab is, biomarkers that would help to identify~     potential treatment-responders or non-responders would support their targeted use and would~     be appreciated by all stakeholders.~      Nuclear magnetic resonance (NMR) spectroscopy is a method that generates comprehensive~     metabolic profiles from human biofluids, and these metabolomic profiles may be useful to~     identify biomarkers with discriminative and predictive power in CD. Thereby amongst other~     factors serum metabolites are affected by inflammation and urine metabolites are affected by~     gut flora and thus one or a combination of both may be a valuable tool in CD.~      Aim: The investigators aim is to identify metabolomic predictors of clinical response to~     adalimumab treatment in CD patients in order to direct future treatment to a group of~     patients that is expected to benefit most.~      Methods: Metabolomic profiling together with the collection of clinical data will be~     performed in patients with IBD prior to treatment with biological therapy and for up to 6~     month thereafter.~      In the study the investigators follow 50 patients with Crohn's Disease, naive to treatment~     with biologics. Metabolomic profiling will be performed 1 week prior to the treatment with~     adalimumab and then every 4 weeks for 6 month. In order to be reliable and reproducible,~     sampling will be performed in the morning after an overnight fasting period. On the days of~     serum/urine collection the following data will be collected: CBC, ESR, CRP, Calprotectin,~     ASCA/pANCA, IL-10, TNFα, IFNγ, Crohn's disease Activity Index, present medication and OTC,~     Dietary and lifestyle history including 24 hour dietary recall, alcohol intake, smoking and~     exercise.~      Multivariate analysis will be performed to identify patterns in the metabolomic profile that~     predict response or non-response to adalimumab treatment.~      To summarize, IBD is a major burden to patients and society. Adalimumab treatment is helpful~     in steroid refractory patients. Novel biomarkers that help physicians to decide which patient~     might benefit from adalimumab treatment may be powerful tools to optimize directing these~     powerful but expensive and side effect bearing therapies towards the patient that might~     benefit most. Metabolomic profiling may be the tool that helps us to identify these patients.~   "
187850|NCT01105728|"~     Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get~     resected because of their malignant potential. To minimize the associated surgical trauma~     endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic~     resection of gastric subepithelial masses is investigated. Since there is a certain risk of~     perforation due to the procedure, perforations get closed by placement of endoscopic clips~     (over-the-scope-clip [OTSC] clips).~   "
187851|NCT01105715|"~     The investigators hypothesize that cLDL levels are elevated in RA patients and represents an~     important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease~     (CVD) in rheumatoid arthritis (RA) patients. The purpose of this study is to improve~     understanding of the reasons for increased cardiovascular diseases (such as heart attack and~     stroke) seen in patients with rheumatoid arthritis (RA, an arthritis that causes inflammation~     and destruction of joints). Specifically, the study plans to determine whether a particular~     type of change in proteins in LDL cholesterol (bad cholesterol) known as carbamylation is~     an important risk factor for cardiovascular diseases in RA patients. The study will utilize a~     case−control study design. A total of 120 subjects (males and females between the ages of 18~     and 80) may be enrolled in order to ensure that 100 subjects (50 RA case subjects and 50 age~     and sex matched controls) complete the study. Procedures will consist of a single visit for~     each subject during which a screening evaluation, an enrollment evaluation, and a single~     blood draw will be performed.~   "
187852|NCT01105702|"~     This pilot phase II trial studies how well giving temozolomide, bevacizumab, lithium~     carbonate, and radiation therapy works in treating patients with newly diagnosed high grade~     glioma.~   "
187881|NCT01105325|"~     To study compliance with secondary prevention during the first months following discharge~     from the cardiac intensive care unit (CIC) of patients experiencing a first episode of acute~     coronary syndrome : quantitative compliance over 3 months with the two principal treatments~     of the prescription (a statin - rosuvastatin, Crestor® and a platelet aggregation inhibitor -~     clopidogrel, Plavix®), using an electronic measure system (intelligent blister pack®);~   "
187853|NCT01105689|"~     Background:~      Vitamin D plays a key role in calcium absorption in the gut and in skeletal development.~     Vitamin D deficiency is common, affecting an estimated one billion people worldwide,~     including developed countries. Vitamin D deficiency causes rickets, the most common~     non-communicable disease of childhood. Rickets causes poor growth and skeletal deformities~     and, at its most severe, seizures and death. Recent data suggest that children with rickets~     have an increased risk for developing diabetes mellitus.~      Screening for vitamin D deficiency is not commonly done. It is generally diagnosed only after~     symptoms of rickets have developed. Prevention and treatment is simple and inexpensive.~     Hence, early detection of vitamin D deficiency through screening would be beneficial. Studies~     are urgently needed to validate such screening tests.~      Calcium balance is tightly regulated in the body and calcium loss in the urine (measured by~     the urine calcium-to-creatinine ratio) is a sensitive indicator of reduced calcium~     absorption, such as in vitamin D deficiency.~      Objective and Hypotheses. The objective of this study is to evaluate the urine~     calcium-to-creatinine ratio as a noninvasive and inexpensive screening test for vitamin D~     deficiency. Our hypotheses are 1) that the urine calcium-to-creatinine ratio correlates with~     blood vitamin D levels in infants and toddlers at risk for vitamin D deficiency and 2) that~     this test can be used to screen for vitamin D deficiency.~      Potential Impact. A validated screening tool would allow for the detection of vitamin D~     deficiency before the development of rickets, decreasing the morbidity and mortality of this~     common disease.~   "
187854|NCT01105676|"~     To take part in this study you/your child have a vascular malformation, a type of blood~     vessel disorder whose cause is unknown.~      The investigators will do this by looking at changes in the genes and proteins in the cells~     of the malformation as well as normal cells.~      The investigators are doing this research because currently there is no known cause of~     vascular malformations and no way to know whether or not other health problems will occur in~     addition to the malformation. Through this research we hope to create standard methods for~     doctors to examine and treat people with vascular anomalies.~   "
187855|NCT01105663|"~     PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This~     study will provide data that may allow for improved dosing recommendations in this critically~     ill population of children.~   "
187856|NCT01105650|"~     This is a single center phase II trial designed to optimize a clinical platform of~     lymphodepleting chemotherapy and T-cell suppression to promote the persistence, function, and~     expansion of allogeneic natural killer (NK) cells in patients with recurrent ovarian,~     fallopian tube, primary peritoneal cancer and advanced metastatic breast cancer.~   "
187857|NCT01105637|"~     Burn injuries can affect how well you are able to perform daily activities. The reason this~     study is being done is to find out if aerobic exercise helps burn patients recover function,~     strength and stamina.~      Participants will come to Johns Hopkins Bayview Medical Center, Burn Rehabilitation Gym for~     treadmill exercise sessions 3 days per week for 12 weeks. Participants will be tested for~     strength and stamina before the start of the 12 week program, at the end of the 12 week~     program, as well as 6 months, 1 year and 2 years after the end of the 12 week program.~      Patients who recently suffered a burn injury and who were discharged from the hospital in the~     past six months may be eligible to participate.~   "
187858|NCT01105624|"~     The primary objective of this study is to compare the duration of subject reported~     comfortable contact lens daily wear time in subjects with a history and current complaint of~     CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to~     rewetting drops~   "
187859|NCT01105611|"~     The purpose of this study is to compare how safe, tolerable, and effective a novel drug,~     raltegravir, is to a commonly used combination, atazanavir/ritonavir, as initial treatment in~     HIV/Hepatitis C co-infected injecting drug users on a methadone program.~   "
187860|NCT01105598|"~     This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with~     mild dyslipidemia.~   "
187861|NCT01105585|"~     The purpose of this study was to prospectively compare high-order aberrations between eyes~     implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted~     with the Tecnis ZCB00 IOL.~   "
187862|NCT01105572|"~     The hypothesis is that use of Internet-connected home biomonitoring of weight, blood pressure~     and other indicators, in conjunction with nurse case management, will result in improved~     outcome for Medicare beneficiaries with with Congestive Heart Failure; compared to case~     management assistance without the biomonitoring device.~   "
187863|NCT01105559|"~     The purpose of this study is to evaluate the long term immunogenicity produced in children by~     the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT~     00362336).~      Primary Objective: To describe the antibody long term persistence at 3.5 and 4.5 years of age~     following a 3 dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™~     + Oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10 and 14 weeks of age and a~     booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months~   "
187864|NCT01105546|"~     The study evaluates the efficacy and safety of a prophylactic treatment with recombinant~     activated FVII in reducing the frequency of joint bleeds and the development of joint damage~     in children with hemophilia A who develop high-titer inhibitors.~   "
187865|NCT01105533|"~     This study will test a new cancer medication to determine if this medication will block blood~     supply to a tumor and decrease growth of a tumor. This study will also define the safety~     profile and define the safest dose of this new medication for people who have cancer.~   "
187866|NCT01105520|"~     Patients included in the study are treated at the Klinik für Neurochirurgie USZ. The clinical~     course is documented at Paraplegikerzentrum Balgrist using validated diagnostic procedures~     (e.g. SCIM, ASIA, neurophysiology).~      Study aims:~      Prognostic value of clinical diagnosis and additional diagnostic procedures? Which parameters~     exhibit optimal prognostic power? Differences between tumor/AVM associated lesions and~     traumatic lesions? What can we learn for pathophysiology and treatment?~        -  Trial with surgical intervention~   "
187867|NCT01105507|"~     This study will assess the safety, tolerability and efficacy of canakinumab treatment in~     Canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18~     months.~   "
187869|NCT01105481|"~     This study includes two main components: the first screening phase and the second clinical~     intervention phase. During the screening phase, subjects with poor response to clozapine are~     carefully evaluated by chart-review and clinical assessment. Via chart-review, clinical data~     of diagnosis, disease course and previous treatment outcome, and concomitant psychotropic~     agents are obtained. Clinical phenomenology, including psychopathology, psychotic and mood~     symptoms severity and side effect of psychotropic medication are assessed by clinical~     interview and observation, which are conducted by experienced clinicians. Blood sample will~     be also obtained from the subjects for measuring the baseline clozapine drug level and~     extracting DNA for further analysis. Subjects fulfilling the criteria of treatment-resistant~     schizophrenia with poor response to adequate dose and duration of clozapine treatment are~     eligible for the clinical trial phase of 14-week randomized, placebo-controlled amisulpride~     add-on study. In this phase, subjects are randomly allocated to amisulpride augmentation~     treatment group and placebo treatment group. Subjects in the former group will receive~     clozapine and amisulpride combination treatment, while in the latter group will receive~     clozapine and placebo. Outcomes of clinical efficacy and safety are carefully evaluated by~     experienced and well-trained research stuffs in the 14 weeks of clinical study period.~      All of the above studies will be conducted in four hospitals, including DOH Bali Psychiatric~     Hospital, DOH Tao-yan Psychiatric hospital, and the Ju-Shang Psychiatric Hospital. Subjects~     will be recruited from the chronic in-patient settings from these three hospitals.~   "
187870|NCT01105468|"~     The volatile content of the exhaled breath gas of mamma carcinoma patients will be chemically~     analyzed by proton-transfer-reaction time of flight mass spectrometry.~      The goal of the study is to determine typical breath gas components that allow to distinguish~     patients with mamma carcinoma from women without carcinoma. Further, the investigators will~     test whether these breath gas markers can be used as tumor markers, which change in a typical~     manner during the progress of the disease. Finally the data will be investigated for the~     presence of marker components, that identify patients who will develop metastasis.~   "
187871|NCT01105455|"~     Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur~     during pregnancy. GDM increases the risk of medical complications during pregnancy which may~     harm the mother and her baby. Since treating GDM to reduce blood sugar reduces the risk of~     harm, all pregnant women are screened for GDM using a glucose challenge test (GCT). We think~     that a diet containing low glycemic index foods could help keep blood sugar levels normal~     during pregnancy and therefore prevent GDM. Thus, the purpose of this study is to see if a~     diet containing low glycemic index foods will reduced blood sugar after the GCT and reduce~     the prevalence of GDM in women at high risk for the development of GDM.~   "
187872|NCT01105442|"~     The standard treatment for post operative pain is now bupivacaine + sufentanil. The use of~     this combination during fast-track colonic surgery leads frequently to post-operative nausea~     and vomiting and limited mobilisation possibilities. Therefore the department anaesthesiology~     wants to evaluate the use of a different local anaesthetic: levobupivacaine combined with~     morphine on demand. The expectation is that the use of levobupivacaine leads to less side~     effects.~   "
187873|NCT01105429|"~     BMS-820132 is an investigational new drug being developed by BMS for treating Type 2~     diabetes. The purpose of this study is to test the safety/tolerability (potential side~     effects) of single doses of the investigational new drug, as well as the amount of study drug~     in the blood, in subjects with type 2 diabetes.~   "
187874|NCT01105416|"~     The aim of the present study is to prevent or delay the initiation of alcohol use among young~     adolescents being seen in a pediatric emergency department, by enhancing parental monitoring~     and improving parent/adolescent conversations. Previous studies have shown that the pediatric~     emergency department is an excellent location for performing prevention interventions. By~     targeting individuals and their families in the pediatric emergency department (PED), we are~     capitalizing on the opportunity to perform a prevention intervention among a high risk~     population when parent and youth may be particularly receptive to the intervention.~   "
187875|NCT01105403|"~     The purpose of this study is to determine whether POL6326 is safe and clinically active to~     mobilize hematopoietic stem cells followed by transplantation~   "
187876|NCT01105390|"~     This phase II trial is studying how well giving AMG 102 together with pemetrexed disodium and~     cisplatin works in treating patients with malignant pleural mesothelioma. Monoclonal~     antibodies, such as AMG 102, can block tumor growth in different ways. Some block the ability~     of tumor cells to grow or spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving AMG 102 together with pemetrexed disodium and~     cisplatin may kill more tumor cells~   "
187877|NCT01105377|"~     This phase II trial is studying how well giving azacitidine together with entinostat works in~     treating patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as~     azacitidine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving azacitidine together with~     entinostat may kill more tumor cells.~   "
187878|NCT01105364|"~     RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a~     patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or~     bevacizumab, and allow doctors to plan better treatment.~      PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic~     treatment in patients with advanced kidney cancer.~   "
187879|NCT01105351|"~     The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate~     after folic acid supplementation. For example, post supplementation differences in~     (6S)-5-CH3-H4folate between CC and TT are above 30%.~   "
187880|NCT01105338|"~     RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate~     cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene~     or green tea may be more effective in preventing prostate cancer.~      PURPOSE: This randomized phase II trial is studying lycopene to see how well it works~     compared with green tea in preventing prostate cancer in patients previously enrolled in the~     ProtecT trial~   "
187882|NCT01105312|"~     RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy~     using letrozole may fight breast cancer by lowering the amount of estrogen the body makes.~     Giving panobinostat together with letrozole may be an effective treatment for breast cancer.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of panobinostat~     when given together with letrozole and to see how well it works in treating patients with~     metastatic breast cancer.~   "
187883|NCT01105299|"~     The purpose of this study is to characterize and compare the bioequivalence of CJ anastrozole~     [CJ Cheiljedang corp., Seoul, Korea] with Arimidex® [AstraZeneca, Wilmington, DE, USA].~   "
187884|NCT01105286|"~     The purpose of this trial is to compare the anti-psoriatic effect of eight different~     formulations of vitamin D analogues using a psoriasis plaque test design~   "
187885|NCT01105273|"~     Rationale: Chemotherapy with fludarabine, cyclophosphamide and anti-thymocyte globulin may~     induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical~     allogeneic hematopoietic cell transplantation. In addition, depletion CD3±CD19 cells may~     contribute to prevent developing severe acute graft versus host disease (GVHD) in~     haploidentical transplantation.~      Purpose: This phase I/II trial is to evaluate the safety and efficacy of fludarabine,~     cyclophosphamide and antithymocyte globulin with CD3±CD19 depleted graft from haploidentical~     donors in treating patients with aplastic anemia.~   "
187886|NCT01105260|"~     Reconditioning program during the chronic phase of the spinal cord-injury is well known for~     its beneficial effects, but there is no investigation in early rehabilitation consequences.~     Nevertheless, it may be justified : to increase oxygen uptake; to decrease the risks of~     medical complications; or to improve the mobility. The restrictive autonomy is due to~     different factors: firstly wheelchair users reduce their movement because they need technical~     or human help to achieve transfers; and secondly, locomotion is performed by the upper limbs.~     Without specific practice, the upper limbs mechanical and physiological properties do not~     permit exercises that are long and intense. Then, the purpose of this research is to evaluate~     the effects of an 8 weeks interval training program on wheelchair independance during~     inpatient early rehabilitation for spinal cord injury (3 to 6 months post injury) compared to~     a control group (classical rehabilitation program in a physical medicine and rehabilitation~     department).~   "
187887|NCT01105247|"~     The purpose of this study is to establish the safety and efficacy of orally administered~     PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.~   "
187888|NCT01105234|"~     The purpose of this trial is to compare the skin irritation potential of eight different~     formulations of vitamin D analogues after repeated applications on intact skin of healthy~     subjects.~   "
187889|NCT01105221|"~     The purpose of this study is to assess whether acupuncture is more effective than artificial~     tear drop in the treatment of dry eye.~   "
187890|NCT01105208|"~     A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over~     design was used with a washout of 7 days between the two study periods. Treatment groups~     balanced with the same number of healthy volunteers who were randomly (in two strata: male~     and female) assigned to the study drug administration sequences~   "
187891|NCT01105195|"~     The purpose of this study is to 1) identify the common bacterial flora found on the skin~     overlying the lumbar spine, and 2) evaluate the efficacy of readily available~     skin-preparation solutions in the elimination of bacterial pathogens from the surgical site~     following skin preparation (DuraPrep versus ChloraPrep).~   "
187892|NCT01105182|"~     The purpose of this study is to assess short and long term outcomes after radiofrequency~     ablation (RFA) combined with chemotherapy for pulmonary malignancies in patients who are not~     candidates for surgical resection. This study will evaluate the efficacy of RFA combined with~     chemotherapy for the treatment of lung tumors by assessing its impact on local tumor control,~     progression free survival, overall survival, dyspnea score and quality of life (QOL).~   "
187893|NCT01105169|"~     Colorectal cancer is the fourth most common incident cancer and the second most common cause~     of cancer death in the United States, with approximately 150,000 new cases and 57,000 deaths~     per year. High calcium intake and magnesium may protect against colorectal cancer and~     adenoma, however, results have been inconsistent. We found that genetic makeup, associated~     with magnesium absorption and re-absorption, significantly interacted with the calcium and~     magnesium ratio in relation to the both adenomatous and hyperplastic polyps. Participants who~     carried at least one 1482Ile allele (G->A)of TRPM7 and who consumed diets with a high~     calcium/magnesium ratio were at a higher risk of adenoma and hyperplastic polyps than were~     participants who did not carry the polymorphism. We hypothesize that the reduction in the~     dietary Ca/Mg ratio may change the markers directly related to tumorigenesis. The primary~     aims of this study are to conduct a randomized placebo-controlled intervention trial to test~     whether reducing the Ca/mg intake ratio through magnesium supplementation has effects on the~     related biomarkers. We will also examine whether the effect of modulating Ca/Mg intake ratio~     may be more pronounced among those who carry the 1482Ile allele compared those who don't~     carry the 1482Ile allele. Results from our study will help to identify people at a high risk~     of colorectal adenoma and to develop personalized strategies to prevent occurrence of~     colorectal adenoma, and thus, colorectal cancer through dietary change or nutritional~     fortification.~   "
187904|NCT01105026|"~     The aim of this study was to evaluate by histology and MSCT scans during a 7-month period,~     the efficacy of a bioactive glass (Inion BioRestore™) placed in human extraction sockets in~     the maintenance of alveolar ridge.~   "
187905|NCT01105013|"~     This is a study clinical, multicenter, Phase III trial, to evaluate the efficacy and safety~     of tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot,~     Tinea and Tinea crural body.~   "
187906|NCT01105000|"~     This is a survey study to assess the vaccination knowledge and attitudes of women in an inner~     city Gynecology clinic. Results of this study will help determine which factors influence~     vaccination knowledge and attitudes. This may help improve future vaccination tools.~   "
188363|NCT01098994|"~     The purpose of the study is to determine whether the function of the good cholesterol (HDL~     cholesterol) as well as its subfractions (via NMR spectroscopy) is altered among people with~     type 1 diabetes and a variation in the Haptoglobin gene and to evaluate whether vitamin E~     supplements may improve this function.~   "
187894|NCT01105156|"~     1. Background / Scientific Rationale~      The VEW (Vomiting, Eating, and Weight Loss) Questionnaire has been developed as a method for~     the assessment of post bariatric surgery patients, as well as a research tool into the eating~     behaviour of these patients.~      Objective VEW Questionnaire Premise If used optimally the VEW score is a valuable tool for~     patients who have had Laparoscopic Gastric Band Surgery (LAGB). The VEW score will be able to~     assist clinicians treating patients with a LAGB, specifically the Swedish Adjustable Gastric~     Band (SAGB), by providing them a tool to enhance patient outcomes. By using the information~     gained from the VEW questionnaire we can assess many areas of the eating behavior, and~     adjustment outcomes in patients with Gastric Bands.~      Hypotheses:~        -  The VEW questionnaire aids in the assessment of the need for gastric band adjustment (up~          or down in volume)~             -  Comparison of patient factors in those who have had a~                  1. good outcome (increased weight loss)~                  2. bad outcomes (vomiting, low weight loss, maladaption), from a gastric band~                    fluid addition~             -  In patients who have had a bad outcome, which factors are more predictive?~        -  Fewer Complications associated with Gastric Band Adjustments~             -  Obstruction~             -  Need for urgent deflation~             -  Pain on eating~             -  Lowering incidence of inappropriate fills~             -  Lower incidence of maladaption~        -  Eating behavior can predict long term outcomes~           o By comparison of factors in the different quartiles of weight loss (particularly top~          25% cf. bottom 25%)~        -  Maintenance of weight loss after 12 months is best achieved by use of behavior~          modification via improved food tolerances and better eating behavior than by increasing~          restriction of the band by further adjustments. 12 months is chosen as an arbitrary time~          where the majority of expected weight loss (45% of expected 50-55% 0f EWL) has been~          achieved. It is also a time frame by which patients have learnt to use the band~          appropriately, and the gastric band has had time to be adjusted into its optimal range.~        -  The VEW questionnaire can help predict poor outcomes from a SAGB adjustment.~             -  By analyzing the factors in patients who have returned both acutely (days) or at~               subsequent visits (weeks) and had fluid removed from their bands. These factors~               would include pain, vomiting, length of meals, maladaption score, fluid added, etc.~   "
187895|NCT01105143|"~     The investigators here propose to perform a prospective randomized intervention trial in~     post-menopausal women to investigate the endocrine network, which contributes to the changes~     in skeletal muscle mass during weight loss.~   "
187896|NCT01105130|"~     RATIONALE: L-arginine supplements may improve the quality of life and erectile function in~     men who are prostate cancer survivors.~      PURPOSE: This randomized phase II trial is studying how well L-arginine supplementation works~     with or without enzyme inhibitors in treating erectile function and quality of life of~     prostate cancer survivors previously treated with radiation therapy.~   "
187897|NCT01105117|"~     This is an open-label, non-randomized extension to study AC-066A401. The study will assess~     safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a~     means for continuing treatment after ending participation in study AC-0066A401.~   "
187898|NCT01105104|"~     The goal of the Enhanced Medication Management Program (eMMp) being developed by MedMinder~     Systems, Inc. is to increase the ability of frail elders to adhere to complex medication~     regimens for chronic conditions. Adherence will facilitate effective self-care and decrease~     personal and societal costs associated with disease progression and loss of independence.~     Multiple studies have shown that more frequent personal follow-up is the most effective way~     to maximize medication adherence, but such personal care is too costly to translate well to~     real life in a world of limited healthcare resources.~      Currently available smart pillboxes are too expensive, too limited in the number and types~     of medications delivered, and too technically complex for the large majority of senior~     citizens. The eMMp is designed to deliver prompts and reminders to the user, to be remotely~     programmable by caregivers, to allow the option of using pre-filled medication trays, to~     provide electronic adherence reports to family/caregivers and to provide personalized~     reinforcing phone calls from professional caregivers, all at a modest cost. The in-home~     ReMinder will use a familiar pillbox layout (4 doses/day for 7 days) and allow easy removal~     of medication cups by elderly, rheumatic fingers. Installation will require only an~     electrical outlet (no modems or dedicated phone lines). Once plugged in, the built-in pager~     will continuously download remotely programmed visual and/or aural prompts and reminders from~     a central server (RemoteMind). It will continuously upload the date and time when each~     medi-cation cup is removed and when weekly refill is carried out, enabling remote adherence~     monitoring, alerts to caregivers, and follow-up intervention(s) from personal and/or~     professional caregivers as needed.~      The hypothesis to be tested in this 2 year SBIR Phase I work plan is that the eMMp will~     significantly im-prove adherence and clinical outcome (blood pressure control) in a~     population of frail elderly who are hyper-tensive. SBIR Phase II will determine the minimum~     level of intervention needed to achieve sustained medication adherence and control of blood~     pressure in a larger group of hypertensive elders.~   "
187899|NCT01105091|"~     This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study~     comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and Flolan~     (epoprostenol sodium) in patients with pulmonary arterial hypertension who are naïve to~     injectable prostanoid treatment and in need of such treatment. Approximately 30 patients from~     8 U.S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2:1~     respectively) for 28 days of treatment.~   "
187900|NCT01105078|"~     Regardless of the development of cardiac surgery techniques and technologies, the question of~     an optimal extracorporeal circulation is still unanswered. There are globally accepted~     standards of perfusion, however, keep many of these procedures was not evidence-based review.~      Generally accepted are flow rates during cardiopulmonary bypasses of 2.5 L/min/m2. This~     target was derived from the physiological conditions, but they are not the result of an~     adapted adjustment to the fundamentally non-physiological processes during extracorporeal~     circulation. Among other things, an increased metabolic demand during re-perfusion is not~     taken into account.~      An increasing and optimizing of the standard flow rate of 0.5 L/min/m2 should be the aim of~     this investigation. Under optimal perfusion, the investigators are maintaining the~     microcirculation and organ protection in receipt of endothelial function and oxygen~     transport.~   "
187901|NCT01105065|"~     The investigators have completed a study in which the investigators examined the response of~     the retinal circulation to changes in posture from sitting to lying down in patients with~     Normal Tension Glaucoma (NTG). This alteration in position produces changes in the local~     blood pressure at the entrance to the retinal vasculature. In a healthy retina, the~     vasculature adapts by dilating and constricting in order to maintain a steady blood flow~     rate. In an eye with NTG, this often does not occur. Upon analysis at the completion of the~     study , the investigators found that the patients who had been taking Alphagan (brimonidine)~     during the study did not exhibit the blood flow increases typical of NTG while lying down;~     instead, they maintained a steady blood flow rate as did the group of healthy control~     subjects. The investigators primary objective is to now demonstrate in a prospective study~     that Alphagan can restore retinal vascular autoregulatory function in patients with NTG who~     do not autoregulate. The investigators will also determine the effect of Alphagan treatment~     on the patients' ability to detect motion.~   "
187902|NCT01105052|"~     The purpose of this study is to investigate whether a self-help book for insomnia, with or~     without therapist support, can improve sleep and alleviate insomnia symptoms in individuals~     suffering from insomnia, also for persons presenting with different kinds of co-morbid~     problems.~   "
187903|NCT01105039|"~     Pain after laparoscopic groin hernia repair consist of different pain components (overall~     pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out~     which of these pain components that is most severe, so intervention can be targeted.~   "
187907|NCT01104987|"~     This prospective study will assess the effects of treatment with alendronate in osteoporotic~     patients with ankylosing spondylitis.~      Primary objectives:~        -  To investigate if alendronate effect bone mineral density (BMD) assessed by dual energy~          x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed by~          quantitative computed tomography (QCT) in lumbar spine and by Xtreme CT in radius and~          tibia.~      Secondary objectives:~        -  To investigate if alendronate effects markers of bone remodeling~        -  To investigate if alendronate influences disease activity (BASDAI), spinal function~          (BASFI), spinal movement (BASMI) and health related quality of life (SF-36).~   "
187908|NCT01104974|"~     This is a survey study to assess the variability in the current management of pregnancy,~     reproductive care and assisted reproductive technologies for HIV-positive individuals in~     Canada to estimate interest for further projects.~   "
187909|NCT01104961|"~     The goal of this study is to investigate the overall theory that the use of chemically~     preserved solutions associated with contact lenses promotes an increase in bacterial~     infection.~   "
187910|NCT01104948|"~     This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing,~     dose-escalation study. The study is designed to describe the relationship between multiple~     doses and pharmacokinetic parameters of DA-8031 as well as safety profile.~   "
187911|NCT01104935|"~     To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and~     combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized~     controlled trial in women over 70 years with human epidermal growth factor receptor type-2~     (HER2) positive primary breast cancer.~   "
187912|NCT01104922|"~     The primary objectives of this study are to determine the 1-year progression-free survival~     (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck~     (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities~     associated with the above therapy.~   "
187913|NCT01104909|"~     End-stage renal disease (ESRD) is a common clinical condition. In this population, the~     prevalence of systemic hypertension is high and its adequate control can determinate the~     outcome.~      The first step for a good control of blood pressure in renal patients is adjusting his/her~     dry weight. Actually, dry weight is assessed based on clinical examination and blood~     pressure.~      The electrical bioimpedance is a simple and portable device. The investigators design a~     randomized clinical trial for evaluating two ways of getting the best dry weight for~     hemodialysis patients.~      A basal 24h ABPM will be taken before the randomization. Then, 2 weeks later the dry weight~     be revised, the investigators will get a second 24h ABPM.~   "
187914|NCT01104896|"~     Nicotine patches are frequently used in smoking patients during their stay in the ICU in~     order to avoid tobacco's weaning symptoms which are likely to interfere with mechanical~     ventilation weaning.~      Until now the effectiveness of this treatment has not been proven. The aim of this study~     (NICOREA study) is to determine if a difference exists on the duration of mechanical~     ventilation once patients receive or not a nicotine substitute.~   "
187915|NCT01104883|"~     The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at~     reducing morphine consumption and pain, and at the same time improving mobilisation after~     total knee arthroplasty.~   "
187916|NCT01104870|"~     This is a prospective, randomized, parallel group study to assess the hemodynamic effect of~     three different dose regimens of a sustained release (SR) tablet of UT-15C in patients with~     exercise-induced pulmonary hypertension (PH), as measured by the change in peak total~     pulmonary resistance index (TPRI) during exercise from Baseline to Week 12.~   "
187917|NCT01104857|"~     Respiratory muscle dysfunction in critically ill patients is associated with elevated~     morbidity, including prolonged weaning from mechanical ventilation. The causes for~     respiratory muscle dysfunction in these patients is poorly understood and no effective~     treatment is available.~      The general hypothesis of the present study is that in critically ill mechanically ventilated~     subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of~     proteolytic cascades.~   "
187918|NCT01104844|"~     The aim of the study is to examine the dose response relationship in the treatment of dental~     pain (teeth extraction) for the different potential doses of the investigational drug, i.e. 2~     tablets, 1 tablet or ½ a tablet given 4 times a day.~   "
187919|NCT01104831|"~     Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21~     degree cryotherapy sleeves. Time to discharge and complications will be monitored.~      Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome~     measures: Satisfaction/pain relief and narcotic requirement~   "
187920|NCT01104818|"~     National estimates indicate that roughly 70% of children in foster care have one or more~     siblings also in care. Exact percentages vary by state, but several data sources suggest that~     about 50% of early adolescent foster youth are placed apart from one or more of their~     siblings. Relationships between these siblings may be critical in providing them a sense of~     connection and emotional continuity as they are removed from much that is familiar (e.g.~     their home, parents, and friends). Historically, efforts to strengthen ties of foster~     children with their families have focused on adults (e.g., biological parents, grandparents).~     Limited research exists on the relationships of siblings in foster care. The central aim of~     the proposed study is to evaluate the impact of the Sibling plus Parent Management Training~     (SPMT) intervention as compared to Parent Management Training-only (PMT) on key constructs of~     sibling relationship quality, mental health, academic success, and quality of life for youth~     in foster care. Conducted in partnership with the Oregon DHS Foster Care program, 240 sibling~     dyads and their foster parents will be enrolled in six cohorts. Siblings may live together or~     in separate placements. Dyads will consist of (1) a target youth in care that is 11-15 years~     of age, and (2) a younger sibling in care who is 7-15 years of age and within 4 years of age~     of the target youth. Sibling dyads will be matched as living together or living apart; the~     matched dyads will be randomly assigned to either the SPMT or PMT-only group, with all~     study-enrolled foster parents receiving PMT intervention components. The SPMT intervention~     includes a sibling component as well as foster parent PMT. The sibling intervention component~     includes eight cognitive behavioral sessions of skills learning/practice, and four community~     activities planned by siblings with their interventionist coaches. For foster parents, there~     is a 4-session PMT curriculum emphasizing skills learning and practice with their~     study-enrolled foster child. Additional sessions are available to foster parents on request.~     Foster parents will also be able to access and troubleshoot PMT materials and strategies via~     weekly staff check-in calls, and the project website. Major wave assessments will be~     conducted at baseline, intervention termination (6 months), follow-along1 (6-month~     post-intervention) and follow-along2 (12-month post-intervention). Brief, bi-monthly phone~     interviews for youth and foster parents will collect service utilization data and global~     ratings of outcome constructs for use in growth-modeling analyses. Hierarchical Linear Models~     (HLM) and multiple regression analyses will be used to test (1) the prediction that SPMT~     siblings will improve more than PMT siblings on key outcomes, and (2) whether intervention~     efficacy varies by sibling placement (together vs. apart) and participant characteristics~     such as race, gender, and disability~   "
189324|NCT01086384|"~     This study will establish the safety as well as demonstrate benefit of the addition of a LABA~     to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on~     both safety and efficacy.~   "
187926|NCT01104740|"~     Dengue is an infectious disease most prevalent in the world. This disease is endemic in the~     Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent~     years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have~     emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a~     classical form with fever, and even of severe or lethal bleeding. With the possible existence~     of silent forms of the disease, there are no data identifying the current level of protection~     of the population in Martinique / Guadeloupe.~   "
187927|NCT01104727|"~     The aim of this study is to compare results of the new surgical strategy to the traditional~     4-ports technique for cholecystectomy in a randomized controlled trial (RCT). In particular~     we are going to investigate the procedures in terms of overall morbidity, while taking into~     considerations skin-incision's related morbidity, postoperative pain and cosmetic results~     which are the hypothetical benefits of the new approach. Other parameters are supposed to be~     unchanged, considering evidences from recent literature.~      Surgical procedures:~      4 ports cholecystectomy (4PC): a 12mmHg pneumoperitoeum is created either by a 10mm umbilical~     Hasson's port or by a Verress needle followed by a 10mm umbilical port insertion; further one~     10mm and two 5mm ports are placed according to the preferred technique.~      Single Port Access cholecystectomy (SPC): the single-port device is inserted through the~     umbilicus, by means of an adeguate incision, as the only access to the abdominal cavity. A~     trans-abdominal suture in right hypochondrium is placed through the gallbladder wall of the~     fundus to retract it.~      Primary endpoint: overall morbidity rate (at 60 days from surgery)~      Secondary endpoints:~        1. skin-incision's related morbidity rate (at 60 days from surgery)~        2. perioperative pain~        3. cosmetic results~        4. long-term morbidity (12 months)~        5. intraoperative time~        6. conversion SPC to 4PC rate~        7. conversion to laparotomy rate~        8. hospital stay~   "
187928|NCT01104714|"~     The purpose of this study is to determine if there is a correlation between tumor response~     after 3 doses of chemotherapy by induction using Docetaxel, Cisplatine and 5-Fluorouracile~     for advanced stage epidermoid carcinomas of the upper aero digestive tract and the presence~     of one or a combination of 3 genetic polymorphisms and/or 5 intra-tumoral transcriptional~     modifications.~   "
187929|NCT01104701|"~     The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety,~     and tolerability data in patients with type 2 diabetes to assess the feasibility of once~     monthly dosing of the exenatide suspension formulation.~   "
187930|NCT01104688|"~     The development of the abdominal aorta aneurysm is multifactorial. Through use of magnetic~     resonance imaging without contrast, this study will look closely at flow, the stresses hereby~     induced, as well as signs of inflammation in the vessel wall.~   "
187931|NCT01104675|"~     The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of~     patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites~     to be added.~   "
187932|NCT01104662|"~     This is a multicenter, randomized, evaluator-blinded, comparator-controlled study.~     Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of~     renal impairment (creatinine clearance [CLcr] 30 - 50 milliliters per minute [mL/min]~     [moderate impairment] and <30 mL/min [severe impairment]) and by type of infection~     (bacteremia and complicated skin and skin structure infections [cSSSI]) to create 4 cohorts~     defined as follows:~        -  Cohort 1: Bacteremia and CLcr <30 mL/min~        -  Cohort 2: Bacteremia and CLcr 30 - 50 mL/min~        -  Cohort 3: cSSSI and CLcr <30 mL/min~        -  Cohort 4: cSSSI and CLcr 30 - 50 mL/min~      Participants will be treated and evaluated for safety and microbiological and clinical~     efficacy in accordance with their type of infection and degree of renal impairment. Peak and~     trough samples will be collected to assess exposure to daptomycin for participants on Day 1~     and following the 5th dose.~   "
187933|NCT01104649|"~     The hereditary cerebellar ataxias include diverse neurodegenerative disorders. Hereditary~     ataxias can be divided into autosomal dominant ataxias (ADCAs), autosomal recessive ataxias~     (ARCAs), X-linked, and mitochondrial ataxias on the basis of mode of inheritance. The key~     feature in all these disorders is ataxia typically characterised by poor balance, hand~     incoordination, postural or kinetic tremor, dysarthria and dysphagia.~      To date no treatment has been shown to slow progression of the disease and symptomatic~     therapies are limited to few options that are partially effective.~      Purkinje cells project inhibitory signals to the deep cerebellar nuclei(DCN) which have a~     critical role in cerebellar function and motor performance. DCN neurons fire spontaneously in~     the absence of synaptic input from Purkinje neurons and modulation of the DCN response by~     Purkinje input is believed to be responsible for coordination of movement, while uncontrolled~     spontaneous firing of DCN neurons may underlay cerebellar ataxia. Recent studies have~     demonstrated that small-conductance calcium-activated potassium (SK) channels inhibitor are~     able to increase DCN firing rate. Since SK channels are critical regulators of DCN firing~     rate, SK openers such as the drug riluzole may reduce neuronal hyperexcitability and thereby~     be useful in the therapy of cerebellar ataxia.~      On this base the investigators published a pilot study in patients with chronic cerebellar~     ataxia (Ristori et al., Neurology 2010) investigating safety and efficacy of riluzole or~     placebo administration for 8 weeks. The results demonstrated a significative improvement in~     International Cooperative Ataxia Rating Scale (ICARS) global score after four weeks and after~     8 weeks in the riluzole arm.~      The present protocol is aimed at verifying the safety and efficacy of riluzole administration~     for a longer period, in a larger sample size of patients, with more stringent diagnostic~     criteria (hereditary cerebellar ataxia), respect to the above pilot study. Sixty patients~     will be enrolled in a double-blind, placebo-controlled trial. By central randomisation,~     patients will take 50 mg of riluzole or placebo twice daily for 12 months. Treatment effects~     will be assessed by comparing the Scale for the Assessment and Rating of Ataxia (SARA) before~     treatment and during therapy at months 3 and 12.~   "
187934|NCT01104636|"~     The aim of this study is to determine the success rates for stopping smoking with varenicline~     in Germany. The main measure of success will be continuous abstinence from smoking (not a~     single puff) in the last week of the standard 12 week treatment period. Additional~     information will be gathered regarding prescribing practices in Germany, smoking history,~     reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the~     tolerability of varenicline.~   "
187935|NCT01104623|"~     The purpose of this study is to detect specific vocal acoustic patterns in the voice of~     attention deficit hyperactivity disorder (ADHD) patients.~   "
187936|NCT01104610|"~     The purpose of this study is to investigate the evolution of daytime partial pressure of~     carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support~     ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP)~     alone versus NIV-PSV.~   "
188364|NCT01098981|"~     This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and~     safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen~     activator (tPA) treatment in subjects with acute ischemic stroke.~   "
187937|NCT01104597|"~     Previous research has shown that Asian Indians are at relatively high risk for developing~     diabetes, heart problems and high blood pressure.~      The purpose of this study is to evaluate subclinical atherosclerosis (an early sign of heart~     disease) which may be associated with abnormalities like diabetes mellitus, hypertension~     (high blood pressure), high cholesterol and heart problems.~      Endothelium is the inner lining of your blood vessels. Endothelial dysfunction is found more~     in people with diabetes. In addition, high body mass index (BMI) is a strong risk factor for~     developing metabolic abnormalities like diabetes mellitus. This research study may provide~     information as to how useful endothelial dysfunction will be to detect people at risk of~     metabolic abnormalities and heart disease at an early stage.~      Two groups of subjects will be enrolled. Caucasians and Asian Indians There will be a total~     of 100 subjects participating in this study. Approximately 50 Caucasians and 50 Asian Indians~     will be enrolled. Caucasians will serve as the control group for this study.~   "
187938|NCT01104584|"~     The purpose of this study is to look at the efficacy (how does it work) and safety of~     gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of~     breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the~     breasts as MRI may detect additional breast cancers~   "
187939|NCT01104571|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Lapatinib ditosylate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet~     known whether trastuzumab or lapatinib ditosylate is more effective in treating women with~     early breast cancer.~      Update June 2013:~      Since the initial development of EPHOS-B in 2007 more evidence in relation to safety and~     efficacy of anti-HER2 therapies are now available, and in particular, a growing body of~     evidence that combinations of two anti-HER2 therapies are more effective than monotherapies.~     Therefore this study has been amended (PART 2) to a 1:1:2 ratio to control, perioperative~     trastuzumab or the combination of lapatinib and trastuzumab.~      PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works~     compared with lapatinib ditosylate (and in since June 2013 - Part 2 - compared with a~     combination of lapatinib and trastuzumab) in treating women with early breast cancer.~   "
187940|NCT01104558|"~     At present, there is some clinical data for different functional response to beta-blockers~     associated with beta-adrenergic receptor polymorphisms. But there has been no data reported,~     about the incidence of beta-adrenergic receptor polymorphism and association with~     beta-adrenergic receptor polymorphism and response to beta-blocker therapy in Korean heart~     failure (HF) subjects. This single-arm, open-label, multicentric study is designed with the~     purpose of analyzing the association between genetic polymorphism of beta-adrenergic receptor~     and the effects of beta-blocker (bisoprolol) in Korean HF subjects.~   "
187941|NCT01104545|"~     This study will determine if MK3614, given as single doses, is safe and well tolerated in~     healthy males and male subjects with mild to moderate hypertension.~   "
187942|NCT01104532|"~     The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety~     following the administration of ASP1941 and sitagliptin in single and multiple doses.~   "
187943|NCT01104519|"~     A study to evaluate the inter- and intra subject variabilities of flow-mediated dilation~     (FMD) of brachial artery and nitroglycerin (GTN) induced dilation of brachial artery.~   "
187944|NCT01104506|"~     In the context of an insufficiency of clinical results for cortical stimulation in treatment~     of brachial plexus post-avulsion pains, one of the possibility for failure is the bad~     pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). This~     purpose of this study is to realise a precise mapping of the primary motor cortex post~     brachial plexus avulsion.~      The principal endpoints is to identify and test the reliability of a muscular marker for~     which the cortical representation is localized immediately next to the superior member area.~     Several muscles of cephalic, cervical and chest area will be investigate.~      The methods used will be mono-shock transcranial magnetic stimulation (mTMS) and functional~     MRI.~      Concerning mTMS, several methods will be tested: best position on the scalp, realisation of~     outputs maps with extreme points average method, with mass center method.~      Concerning fMRI studies, the above paradigms will be checked: imaginary movements of hand,~     blow up and down abdomen, eyes winking.~      Statistical tests will confirm the best muscle candidate and will permit to evaluate the~     reliability of the method.~   "
187945|NCT01104493|"~     To assess the safety of a new influenza virus vaccine containing a new virus strain in~     healthy patients prior to the release of the vaccine.~   "
187946|NCT01104480|"~     This is a study for one patient with severe relapsing polychondritis which has been~     unresponsive to other more conventional medications including prednisone, methotrexate,~     anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be~     monitored by clinical assessment and bloodwork.~   "
187947|NCT01104467|"~     The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given~     to Japanese patients with acute ischemic stroke~   "
187948|NCT01104454|"~     The purpose of this study is to standardize methods in collecting and processing placenta,~     umbilical cord and cord blood samples. Samples will be used to determine potential~     differences between normal weight, overweight and obese individuals.~   "
187949|NCT01104441|"~     Acetylsalicylic acid (Aspirin, ASA) is the most widely prescribed drug used in primary and~     secondary prevention of cardiovascular disease. However, aspirin resistance has been~     described, mostly in cardiac patients and is an independent predictive factor for a poor~     survival. Two frequent conditions in patients with cardiovascular diseases, diabetes and~     hypercholesterolemia, are also considered as risk factors for aspirin resistance. Among~     patients with peripheral arterial disease, those with critical limb ischemia have the worst~     cardiovascular prognosis. At one year, 23% are dead, 25% have a major cardiovascular event~     and 25% have a major amputation (which can be combined). Aspirin resistance is poorly studied~     in these patients, and to our knowledge no study has been made to assess the prognosis value~     of aspirin resistance on cardiovascular outcomes in critical limb ischaemia patients.~      Hospitalized critical limb ischaemia patients will be tested for aspirin resistance using the~     bed-side point of care VerifyNow®, and will be followed during one year, including death,~     fatal and non-fatal acute coronary syndromes, cardiac decompensation, stroke, and major~     amputation.~   "
187950|NCT01104428|"~     Due to high incidence of renal damage by Hench-schonlein Purpura(HSP) is the key to affect~     prognosis, this project moves the research emphasis forward in line with the idea of~     prevention of progress of disease, Which concerns on Traditional Chinese Medicine(TCM)~     clinical research scheme evaluation of HSP, evaluates the renal damage and disease recurrence~     as the end event, and comes to the evaluation through the comparative study that the vantage~     point of the scheme of syndrome differentiation and treatment in detoxification, cooling~     blood and removing blood stasis to the conventional treatments can reduce kidney damage and~     recurrence rate.~   "
187951|NCT01104415|"~     The purpose of the study is to evaluate the safety and tolerability of multi-dose, open-label~     LX606 in subjects with symptomatic carcinoid syndrome.~   "
187952|NCT01104402|"~     Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent~     acute exacerbations of their lung disease. Most exacerbations are not treated until they~     cause increased symptoms, and patients seek medical attention. This proposal details a study~     of home lung function and symptom monitoring. Subjects will be randomly assigned to one of~     two groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard~     care. The home monitoring data will be transmitted electronically to the study center. If~     spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary~     exacerbation will be initiated. It is anticipated that use of home monitoring will lead to~     earlier, more reliable recognition and treatment of exacerbations, which will translate into~     better lung health.~   "
187953|NCT01104389|"~     A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical~     System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors. To determine the~     feasibility of the fluorescence imaging on the da Vinci Surgical System in robotic partial~     nephrectomy procedures and report perioperative outcomes.~   "
187954|NCT01104376|"~     The purpose of this study is to see if administration of medicines and genetic differences~     affects the activity of a liver enzyme called CYP2B6 in healthy volunteers.~   "
187955|NCT01104363|"~     The purpose of this study is to evaluate the effectiveness of heavy Vinyl PolySiloxane (VPS)~     and splinted implants impression (Study Group, SG) technique versus plaster implant~     impression (Control Group, CG) technique, in 12 edentulous patients rehabilitated with the~     All-on-4 concept and Procera® Implant Bridge (P.I.B.). A longitudinal, double blinded,~     randomised clinical trial (RCT) was designed to evaluate the accuracy of the impression. All~     patients were monitored from implant placement until prosthetic loading.~   "
187956|NCT01104350|"~     The purpose of this study is to test the safety of different amounts (doses) of external~     radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with~     chemotherapy.~   "
187957|NCT01104337|"~     The objective of this study is to investigate whether paracetamol, given at therapeutic doses~     (2g/day and 3 g/day), may potentiate the anticoagulant effect of warfarin.~   "
187958|NCT01104324|"~     Acute lymphoblastic leukemia is the most common form of childhood cancer with current~     treatment survival rates approaching 80%. Improved outcomes show an increased number of~     survivors at risk for long-term treatment related side effects including osteonecrosis.~     Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and~     poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the~     usual presenting symptom and may become severe requiring surgical decompression or~     replacement of the affected joint. Long-term effects including arthritis and progressive~     joint difficulties will not be known for decades. This study aims to determine the risk~     factors for developing osteonecrosis that will lead to information for earlier detection and~     prevention. The study will be the basis for future intervention and prevention trials.~   "
187959|NCT01104311|"~     To develop adequate blood pressure (BP) lowering strategy after subacute ischemic stroke~     patients with symptomatic severe intracranial atherosclerosis.~      Primary hypothesis of this study is that aggressive BP control (lowering systolic BP between~     110mmHg and 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to~     modest BP lowering (lowering systolic BP between 130mmHg and 140mmHg) in the patients with~     symptomatic severe intracranial atherosclerosis.~   "
187960|NCT01104298|"~     The proposed investigation intends to explore if the combination of trabectedin and~     doxorubicin in the first line of treatment of advanced sarcomas obtains better results than~     doxorubicin monotherapy~   "
187961|NCT01104285|"~     The purpose of this study is to determine whether chest tubes to drain transudative pleural~     effusions helps patients come off mechanical ventilation earlier.~   "
187962|NCT01104272|"~     The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt~     subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such~     as a reduction in waist circumference.~   "
187963|NCT01104259|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with cisplatin and vinorelbine ditartrate in treating patients with breast cancer that has~     returned or spread to other parts of the body. Veliparib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     cisplatin and vinorelbine ditartrate, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving veliparib together with combination chemotherapy may be a better treatment~     for breast cancer.~   "
187964|NCT01104246|"~     The study will evaluate the pharmacokinetics of testosterone transdermal systems at~     steady-state in hypogonadal men.~   "
187965|NCT01104233|"~     The purpose of this study is to see if different types of spreading (rigid or soft) of~     Video-assisted Thoracoscopic Surgery (VATS) for lung cancer have different effects on pain.~   "
187966|NCT01104220|"~     The purpose of this study is to learn more about how the body stores fat in and around organs~     (ex. the liver) and why this affects some people's health more than others. Understanding~     this may lead to better treatments for diseases such as diabetes and cardiovascular disease.~   "
187967|NCT01104207|"~     The purpose of this study is to assess the effectiveness of repetitive transcranial magnetic~     stimulation (rTMS) for reducing the loudness or severity of chronic tinnitus.~   "
188365|NCT01098968|"~     EDUFIT is a group-Randomized Controlled Trial specifically designed to enhance physical~     fitness and other health-related factors in a school setting in adolescents.~   "
187968|NCT01104194|"~     The investigators recently found a positive effect of omega-3 supplements on cognitive~     function in healthy individuals after 4 weeks (J of Psychopharmacology 2009, 23: 831-840).~     The investigators hypothesize that 4 weeks consumption of omega-3 supplements in previously~     depressed individuals will positively affect their cognitive functions.~      Secondly, low Heart Rate Variability (HRV) is a risk factor for cardiovascular disease. Some~     studies have found low HRV in patients with depression. No studies have investigated the~     effects of omega-3 fatty acid supplements on Heart Rate Variability in individuals with a~     history of depression. The investigators will test the hypotheses that omega-3 supplements~     lead to an improvement of heart rate variability indices in healthy volunteers with a history~     of depression.~   "
187969|NCT01104181|"~     This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV~     and whether this aids in identifying individuals are risk for anal cancer or precancerous~     lesions.~   "
187970|NCT01104168|"~     Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75~     years and 40% of adults >80years of age. Management of hyperglycemia is challenging in the~     geriatric population in long-term facilities. Numerous factors place hospitalized patients at~     increased risk for hyperglycemia including aging, sedentary life, stress of medical and~     surgical comorbidities, and changes in antidiabetic regimen. In addition, elderly patients~     often experience changes in their nutritional intake and organ dysfunction which increase the~     risk of hypoglycemic events.~      There are only a few retrospective studies in elderly patients analyzing quality of diabetes~     care and glycemic control adjusted for medications and presence of co-morbidities in~     long-term care facilities. In addition, no randomized controlled trials have demonstrated~     benefits of glycemic control on clinical outcome, quality of life, and rate of acute~     metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities.~   "
187971|NCT01104155|"~     This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin~     mesylate in combination with intermittent erlotinib in patients with previously treated,~     advanced non-small cell lung cancer.~   "
187972|NCT01104142|"~     The purpose of this study is to evaluate the effectiveness of the Continuous Glucose~     Monitoring System (DexCom™ SEVEN PLUS®) and to evaluate the impact of CGM on glycemic control~     when worn for up to 6-months by subjects 18 to 70 years-old with Type 1 diabetes mellitus on~     MDI or CSII therapy.~      The primary objective of this study is to demonstrate no statistically significant~     differences between MDI and CSII subjects in terms of A1C change at 6 months as compared to~     baseline. A secondary objective is to evaluate time spent outside of the euglycemic region~     (70 to 180 mg/dL) from the baseline (blinded month) to the conclusion of 6 month follow-up.~      Safety data of the SEVEN PLUS System will also be collected and safety will be characterized~     by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated~     Adverse Device Effects experienced by study participants.~   "
187973|NCT01104129|"~     The purpose of this study is to determine if pancreatic cancer/pre-cancer can be detected in~     early stages through the molecular analysis of stool samples. Investigators hypothesize that~     analysis of stool samples using digital melt curve (DMC) analysis, can be used as a sensitive~     and specific method to detect the common genetic abnormalities present in pancreatic cancers~     and pre-cancerous lesions of the pancreas.~   "
187974|NCT01104116|"~     Intraductal papillary mucinous neoplasm (IPMN) is a cystic pancreatic lesion that is a~     precursor to invasive pancreatic cancer. Differentiating whether an IPMN lesion is benign or~     malignant is critical, as the prognosis and management differs drastically, varying from~     surgery to clinical observation. However, despite physicians' attempts to characterize~     features concerning for malignancy, it is difficult to determine the likelihood of malignancy~     with conventional imaging techniques, and an accurate and non-invasive test to identify~     malignant IPMN is needed. Our hypothesis is that positron emission tomography (PET), a~     three-dimensional imaging that can identify cancer cells through their increased use of~     sugars, may be a superior test for differentiating between benign and malignant IPMN lesions.~     The investigators are planning a prospective pilot study of patients with IPMN who are~     undergoing surgery for their disease. These patients will undergo PET imaging, as well as~     computed tomography (CT), magnetic resonance imaging (MRI), and endoscopic ultrasound (EUS)~     as clinically indicated. Samples of tissue removed during surgery will be assessed and will~     serve as the gold standard for determining whether the lesion is benign or malignant. The~     investigators will evaluate the positive and negative predictive values of PET imaging for~     malignancy within IPMN lesions.~   "
187975|NCT01104103|"~     The purpose of this study is to determine whether the BOA(R)-Constricting IV Band is superior~     to standard methods for starting an IV.~   "
187976|NCT01104090|"~     The purpose of this study is to determine the safety and efficacy of the C-MAC (Karl Storz~     Endoscopy, Inc., Tuttlingen, Germany) video intubation system guided intubation techniques.~      We hypothesize that the C-MAC video laryngoscope is safe and efficacious in terms of~     successful endotracheal intubation. The C-MAC may be a safe and suitable alternative device~     for routine and difficult laryngoscopy and tracheal intubation. This is the first study to~     investigate the performance of C-MAC in clinical practice.~   "
187977|NCT01104077|"~     This is a retrospective observational study to determine the proportion of patients with a~     family history of pancreatic cancer and other malignancies among patients who have~     intraductal papillary mucinous neoplasm (IPMN).~      The investigators will be reviewing the demographic, clinical, radiologic, pathologic, and~     follow-up information from the Pancres Center database. The investigators will also conduct a~     chart review to collect information recorded by clinicians on each subject's family history~     of malignancy and personal history of malignancy. Results of this database and chart review~     will be incorporated into a datasheet in which all patient identifiers have been removed.~      The primary outcome will be the percentage of IPMN patients with at least one first-degree~     relative with pancreatic cancer or IPMN, or at least two first or second degree relatives~     with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes,~     including colorectal, gastric, breast, ovarian, and melanoma neoplasms. Secondary outcomes~     will be the relative risk of IPMN subtypes of higher malignant potential (main duct or mixed~     type location), more advanced histology (carcinoma in situ or invasive carcinoma), and~     recurrence following surgical resection amongst subjects with a family history.~   "
188380|NCT01098773|"~     Prospective observational clinical multicentric study in ICU with ventilated patients~     requiring chest ultrasound analysis.~   "
187978|NCT01104064|"~     The strategy in rehabilitating pediatric hemiplegia is to overcome developmental disuse.~     Disruption of the excitability in the non-stroke hemisphere, with resultant increased~     excitability (disinhibition) in the stroke hemisphere, can be achieved with low-frequency~     repetitive transcranial magnetic stimulation (rTMS), a noninvasive method of stimulating~     targeted areas of the brain. Furthermore, the disruptive effects of low-frequency rTMS can be~     increased and prolonged by preceding it with 6-Hz priming stimulation. We have recently~     demonstrated the safety of this priming/low-frequency rTMS in adults with stroke and we are~     currently engaged in an NIH-funded study exploring the effectiveness, mechanism and safety of~     serial treatments of rTMS combined with motor learning training. Very little research,~     however, has been attempted on interventions to promote brain reorganization and recovery in~     hemiplegia in children. Thus, this study will determine the effectiveness, mechanism, and~     safety of 5 treatments of 6-Hz primed low-frequency rTMS applied to the non-stroke hemisphere~     and combined with constraint induced therapy (CIT) to promote recovery of the paretic hand.~     Fifteen children with pediatric hemiplegia, age 8 -16 years, at each of two pediatric medical~     facilities (total N = 30), will be randomly assigned to one of two treatment groups that will~     receive treatment for 2 weeks. The rTMSreal/CIT group will receive alternating days of the~     real rTMS and CIT for 5 treatments of each. The rTMSsham/CIT group will receive alternating~     days of sham rTMS with real CIT for 5 treatments of each. Subjects will be tested at pretest~     and posttest. The hypotheses are: 1) the rTMS treatment will show no serious side effects, 2)~     both groups will show improvement in hand function but the rTMSsham/CIT group will show~     significantly greater improvement, 3) the rTMSreal/CIT group will also show significantly~     greater improvements in brain reorganization measured by paired-pulse TMS testing, cortical~     silent period testing, and fMRI. The proposed research is important because very little~     research on rehabilitation-induced brain reorganization has been done in pediatric~     hemiplegia. It is innovative because it applies a technique never used before, i.e. 6-Hz~     primed low-frequency rTMS combined with CIT. The potential impact of this research is a~     radical change to pediatric rehabilitation that accomplishes a higher functional recovery.~   "
187979|NCT01104051|"~     Trial will enroll qualified subjects at a 2:1 ration to receive radiofrequency ablation or~     sham. At six weeks follow up they will be unblinded; sham subjects will then be given option~     to receive treatment.~      Subjects will be followed after procedure for data collection for economic outcomes and~     efficacy of treatment.~   "
187980|NCT01104038|"~     Childhood obesity has increased in prevalence over the past several decades and is predictive~     of adult type 2 diabetes and cardiovascular disease (CVD). Recent studies of children and~     youth suggest that exercise reduces cardiometabolic risk factors. Minimal data are available,~     however, on the effects of exergaming , interactive technology- mediated approaches to~     increasing physical activity in children and youth. This project involves a partnership~     between UMass Boston/GoKids Boston and Children's Hospital Boston featuring an~     interdisciplinary team of researchers and clinicians from pediatric cardiology, nursing,~     prevention and behavioral sciences and exercise physiology and is designed to examine the~     effects of exergaming on moderate or vigorous physical activity (MVPA) indices of adiposity,~     risk factors for cardiometabolic disease and self-competence in Boston Public School~     children. It is hypothesized that participation in the EXCEL/exergaming intervention for 60~     minutes, three times per week for 12 weeks will significantly increase MVPA (as measured by~     accelerometers), pre- to- post intervention and compared to an Advice only (Nutrition~     Education) group.Results of this pilot study will guide and inform a larger study of~     exergaming in children from the Boston Public Schools.~   "
187981|NCT01104025|"~     Despite good progress during the last decade, hemophagocytic lymphohistiocytosis (HLH)~     remains difficult to treat. Two different treatment regimens have been used successfully. The~     first one, a treatment regimen based on two drugs called etoposide and dexamethasone, has~     been used worldwide. The second regimen, based on two drugs called Anti-thymocyte globulin~     (ATG) and prednisone, has been used mostly at one hospital in Paris, for over 15 years. With~     either regimen, about three quarters of treated children survive the most difficult time, the~     first two months after diagnosis. These two different regimens appear to work somewhat~     differently, and we suspect that combining them may give better results than either regimen~     alone. We are conducting this clinical trial to test the combination of ATG, dexamethasone,~     and etoposide for the treatment of HLH.~      The purpose of this research study is to find out what effects (good and bad) this drug~     combination has on you and your HLH.~   "
187982|NCT01104012|"~     The purpose of this study is to verify and validate the intrinsic diagnostic value in terms~     of sensitivity and specificity of proteomic profiles determined during a pre-study for~     discriminating between allergy related asthma and allergy related rhinitis.~   "
187983|NCT01103999|"~     Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc~     Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.~   "
187984|NCT01103986|"~     The purpose of this study is to evaluate the effectiveness of a health literacy/motivational~     intervention in a workplace setting. Parents will be taught how to use a child health book to~     lessen inappropriate use of physician services and improve parent confidence in their ability~     to identify and obtain necessary assistance when their children are ill.~   "
187985|NCT01103973|"~     Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment,~     and it may have a detrimental impact on pregnancy rates, yet there is minimal published~     research on the efficacy of structured skills-based psychological interventions with assisted~     reproductive technology (ART) patients. The objective of this study is to determine if women~     who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will~     have higher pregnancy rates than controls (C).~      This is a randomized, controlled prospective study conducted at a private~     academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled~     to undergo their first IVF cycle. Subjects are randomized via computer generated random~     numbers table to a 10 session mind/body program or a control group and followed for two IVF~     cycles. The primary outcome measure is clinical pregnancy rate.~   "
187986|NCT01103960|"~     The primary objectives of this trial is to demonstrate that the fixed-dose combination of~     telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing~     seated trough diastolic blood pressure (DBP) at 8 weeks.~   "
187987|NCT01103947|"~     This study will evaluate the efficiency of the EcoAnesthesia mask and its advantages over the~     standard facemask used in our practice. The satisfaction by the anesthesia provider and its~     ease of use may change the standard practice in airway management. In addition to these~     additional effects on patient safety, the facemask is affordable and may reduce the~     environmental burden of anesthesia waste.~   "
187988|NCT01103934|"~     The objectives of this study would be to see if the addition of vitamin D to fluticasone~     propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis~     compared to fluticasone propionate treatment alone.~   "
187989|NCT01103921|"~     The purpose of this study is to examine the effects of consumption of sugar-sweetened~     beverages on blood triglycerides and cholesterol, cholesterol concentrations, and the body's~     sensitivity to insulin.~   "
187990|NCT01103908|"~     Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in~     pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output~     will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution~     technology. At times, cardiac output will be measured during a procedure called modified~     ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated~     or compared with cardiac output measurements made using other FDA approved techniques and~     devices.~   "
187991|NCT01103895|"~     Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in~     adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured~     before and after cardiopulmonary bypass using a device that employs ultrasound dilution~     technology. The ultrasound dilution cardiac output measurements will be validated or compared~     with cardiac output measurements made using thermodilution, which is the current gold~     standard.~   "
187992|NCT01103882|"~     The primary objectives of this clinical study include:~        -  Assess the rate of dislocation and fracture of THA using the new (the 4th generation)~          ceramic implants.~        -  Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation)~          composite ceramic bearing.~        -  Investigate the performance of the 4th generation ceramic implants mostly in patients~          younger than 50 years.~        -  Compare the preoperative and postoperative scores of Harris Hip Score, UCLA Activity~          Score and WOMAC.~   "
187993|NCT01103856|"~     At Thomas Street Health Center (TSHC), one of the largest outpatient HIV clinics in the~     country, we developed a structured, theory-based, Patient Mentor Program to improve retention~     in HIV primary care. Many patients with HIV infection hospitalized at Ben Taub General~     Hospital (BTGH) do not successfully return to TSHC after discharge from the hospital. The~     purpose of this study is to test the efficacy of a patient mentor intervention in a 5-year~     randomized, controlled trial in more than 430 socio-economically and racially diverse~     HIV-infected patients hospitalized at BTGH. We hypothesize that the intervention will~     meaningfully increase retention in HIV primary care after discharge compared to an attention~     control.~   "
187994|NCT01103843|"~     -  The purpose of this study is to determine the level of inhibition of platelet activation~          of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the~          setting of drug eluting coronary stent implantation.~        -  In subjects with high residual levels of platelet reactivity after receiving either a~          maintenance or loading dose of either clopidogrel or prasugrel, a cross over of~          thienopyridine treatment to the alternate medication will occur.~        -  The study tests the hypothesis that adequate platelet inhibition will occur in subjects~          who have high levels of platelet reactivity and are subsequently switched from~          clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of~          bleeding or MACE events at discharge and 30 days post Percutaneous Coronary Intervention~          (PCI).~   "
187995|NCT01103830|"~     The aim of such a study is to evaluate the impact of a therapeutic dose of Eurartesim™~     compared to Riamet®, after multiple dose administration for 3 days in healthy male and female~     subjects on electrocardiographic parameters.~   "
187996|NCT01103817|"~     The purpose of this study is to study the role of low vitamin D levels on the health of blood~     vessels or vascular function in adolescents and young adults with type 1 diabetes.~   "
187997|NCT01103804|"~     The primary objective of the study is to describe the change in GerdQ sum scores, after a~     4-week period of systematic treatment with PPIs(using GerdQ questionnaire). The secondary~     objectives are: to measure the response at the current treatment after a 4-week period of~     systematic treatment and to identify the percentage of patients which require alterations of~     their treatment (GerdQ questionnaire)~   "
187998|NCT01103791|"~     This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose~     of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety~     and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.~   "
187999|NCT01103778|"~     The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to~     induce complete or partial remission in patients with severe IgA nephropathy.~      The secondary objectives are to assess clinical outcomes relating to safety and efficacy,~     such as infection, malignancy, preservation of renal function, partial responders, relapse~     rate, and to study mechanistic assays to predict remission.~   "
188000|NCT01103765|"~     Comparison with use of Intravascular Ultrasound (IVUS) analysis of two methods of~     percutaneous coronary interventions (PCI) with drug eluting stent:~      After successful drug eluting stent implantation, patients were randomized into two groups:~     Group A had no further dilatation, and Group B had additional post-dilatation with a~     noncompliant balloon. The investigators performed IVUS analysis in groups A and B just before~     randomization and after post-dilatation in group B.~   "
188001|NCT01103752|"~     The aim of this study is to quantify the incidence of postoperative cognitive dysfunction in~     the elderly patient (>60y) after total hip or knee replacement surgery. The hypothesis is~     that the fast-track methodology with a mean hospital stay less than 3 days will help to~     minimize this reduction in memory and concentration.~   "
188002|NCT01103739|"~     The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the~     pharmacokinetics (PK) of co-administered single dose simvastatin.~   "
188003|NCT01103726|"~     We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain~     called the striatum.~   "
188004|NCT01103713|"~     The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia.~     The subjects will be given 3 day dosing regiment of the fixed-dose combination of~     Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction~     data will be evaluated on Day 28 as primary endpoint.~   "
188005|NCT01103700|"~     The purpose of the study is to compare the quality of dying and death of terminal cancer~     patients from the perspectives of medical staff and main care giver (family). The hypothesis~     is that their view points will be different.~   "
188006|NCT01103687|"~     The purpose of this study is to evaluate the safety and immune response of an~     adenovirus-based HIV vaccine in HIV-uninfected adults.~   "
188007|NCT01103674|"~     This is a multi-center, prospective, open label, feasibility clinical study,evaluating the~     safety and efficacy of the combined ablation procedure for the treatment of symptomatic~     paroxysmal atrial fibrillation.~   "
188009|NCT01103648|"~     Ezetimibe specifically blocks the absorption of dietary and biliary cholesterol and plant~     sterols. Synergism of ezetimibe-statin therapy on LDL-cholesterol has been demonstrated, but~     data concerning the pleiotropic effects of this combination are controversial. We tested the~     hypothesis that the combination of simvastatin and ezetimibe would induce improvement in~     inflammatory status, as reflected by leukocyte count and CRP, IL-6 and TNF-a levels. This~     open-label trial evaluated whether this combination results in a synergistic effect the~     pro-inflammatory status of pre-diabetic subjects. Fifty pre-diabetic subjects were randomly~     assigned to one of 2 groups, one receiving ezetimibe (10 mg/d), the other, simvastatin (20~     mg/d) for 12 weeks, followed by an additional 12-week period of combined therapy.~   "
188010|NCT01103635|"~     RATIONALE: Monoclonal antibodies, such as tremelimumab and CD40 agonist monoclonal antibody~     CP-870,893, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry cancer-killing~     substances to them. Giving tremelimumab together with CD 40 agonist monoclonal antibody~     CP-870, 893 may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of giving tremelimumab~     together with CD40 agonist monoclonal antibody CP-870,893 in treating patients with~     metastatic melanoma.~   "
188011|NCT01103622|"~     The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics~     (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.~   "
188012|NCT01103609|"~     The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics~     and Pharmacodynamics of Warfarin in T2DM patients.~   "
188013|NCT01103596|"~     The purpose of this study is to evaluate, in patients in at least the second protease~     inhibitor (PI) line, the virological failures under Kaletra® and their consequences on~     protease and reverse transcriptase genotypes~   "
188014|NCT01103583|"~     The pathogenesis of MS remain elusive, however some studies have linked the disease with~     infection by Epstein-Barr virus; therefore the use of drugs with immunosuppressive or~     immunomodulating action alone may be less suitable for primary progressive MS.This study will~     evaluate treatment with hydroxyurea (HU) in primary progressive MS. Hydroxyurea act by~     inhibiting the synthesis of deoxynucleotides essential for viral transcription,HU has~     recently been used in combination with antiretroviral drugs in HIV and has been shown to~     limit immune activation and suppress viral load by both antiviral and cytostatic activities.~     Furthermore has been demonstrated experimentally that HU suppressed the expression of EBV.~     For these reasons HU could be useful in primary progressive MS with cytostatic and antiviral~     action , confirming the role of EBV in the pathogenesis of MS.~   "
188015|NCT01103570|"~     Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be~     difficult, time consuming and bile duct injury may be caused by attempts to cannulate the~     cystic duct. Operative cholangiography performed by direct puncture of the gall bladder~     fundus or Cholecystocholangiography (CCC) is a valid and easier alternative.~   "
188016|NCT01103557|"~     The purpose of this study is to prospectively analyze the incidence of occult lateral neck~     metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma~     (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck~     dissection (SND).~   "
188017|NCT01103544|"~     Documentation of data concerning tolerability and efficacy of the intravenous treatment with~     vinflunine performed under daily routine conditions in Germany. The trial focusses on~     tolerability including the assessment of the usage of anti-emetic and anti-obstipative~     concomitant treatment as well as on the efficacy of the treatment.~   "
188018|NCT01103531|"~     The purpose of this study is to assess the effects of an aerobic and strength training~     exercise program (one that increases the need for oxygen and increases muscle) on the~     treatment outcomes of 150 individuals in treatment for methamphetamine dependence at~     Cri-Help. The study will determine if a 60-minute exercise program (three times a week) has~     an effect (good or bad) on the health and drug use of participants as compared to individuals~     not participating in an exercise program.~   "
188019|NCT01103518|"~     This is a Phase IV, randomized, double-blind, comparative study of the use of two~     preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual~     irregularities of hyper-androgenic origin.~   "
188020|NCT01103505|"~     The overall objective of this two arm randomized clinical trial (RCT) is to determine if home~     monitoring using the comprehensive visual field and telemedicine solution based on the~     ForeseeHome device in AREDS2 improves detection of progression to choroidal~     neovascularization (CNV) when compared with standard care.~   "
188021|NCT01103492|"~     This study involves evaluating a procedure in which the study device, the HALO90 Ablation~     catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF)~     energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining~     of the rectum caused by the side effects of radiation treatments that can lead to bleeding).~      In medical procedures, the RF energy used with this device, has been historically used in~     shrinking or removing soft-tissue, for surgical cutting, and for stopping bleeding. The~     device is cleared by the Food and Drug Administration (FDA) for use in coagulation (to assit~     with stoping bleeding and clotting of blood) of tissue within the digestive tract. The device~     has been used in areas outside the esophagus (inner lining of the throat), including the~     rectum to treat radiation proctitis. The stoppage of bleeding of radiation proctitis, using~     the HALO device, may be one method to control the bleeding.~      The purpose of this study is to evaluate the effectiveness and record the results of~     treatment of radiation proctitis using the HALO device.~   "
188022|NCT01103479|"~     The purpose of this study is to evaluate the effectiveness of a low literacy, physician and~     patient-directed intervention to promote colorectal cancer (CRC) screening among the~     medically underserved.~   "
188023|NCT01103466|"~     The purpose of this study is to evaluate the performance of Atlas (new base plate) on the~     degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is~     that Atlas will do better than the two comparator products.~   "
188383|NCT01098734|"~     Welichem Biotech has developed a small molecule drug candidate, WBI-1001, that selectively~     targets the pathogenic features of inflammatory skin diseases, including atopic dermatitis (a~     form of eczema).The purpose of this clinical trial is to further test the safety and efficacy~     of WBI-1001 as a topically applied cream over an extended period of 12 weeks on patients with~     mild to moderate atopic dermatitis.~   "
188024|NCT01103453|"~     The aim of the study is to investigate the feasibility of using a virtual supermarket as an~     intervention tool for overcoming deficits in executive function as well as enhancing IADL~     performance among persons with Mild Cognitive Impairment. The working hypotheses are that~     there will be improvement in executive functions, and the improvement in the executive~     functions will result in better performance in Instrumental Activities of Daily Living, both~     generally and especially in shopping task~   "
188025|NCT01103440|"~     The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce~     ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention~     (PCI).~   "
188026|NCT01103427|"~     The purpose of the study is to investigate the effectiveness of a smoking cessation~     intervention delivered through a technological web based platform (www.slutta.no) with or~     without a supportive SMS function.~   "
188027|NCT01103414|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of three dose~     levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes.~   "
188028|NCT01103401|"~     This randomized controlled trial compares two regimens of topical therapy:~        -  tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day~        -  combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four~          times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three~          times/day.~      Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are~     evaluated for~        -  corneal edema~        -  conjunctival hyperemia~        -  anterior chamber (Tyndall) reaction.~      The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an~     antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly~     follow-up, to gain insight into the optimal duration of postoperative treatment and to~     examine whether risk factors for inflammation exist.~   "
188029|NCT01103388|"~     The goal of this clinical research is to see if Rituxan (rituximab) therapy given after high~     dose chemotherapy and transplant of a patients own stem cells will prevent or delay the~     return of the lymphoma.~   "
188030|NCT01103375|"~     This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when~     given with isotretinoin in treating patients with recurrent malignant glioma. Erlotinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Isotretinoin may help cells that are involved in the body's immune response to~     work better. Giving erlotinib hydrochloride together with isotretinoin may kill more tumor~     cells~   "
188031|NCT01103362|"~     To generate additional long-term safety and efficacy data on flibanserin in premenopausal~     women and establish long-term safety and tolerability of flibanserin in naturally~     postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior~     clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).~   "
188032|NCT01103349|"~     This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a~     double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main~     objective is to assess the effect on lung function. The study will also provide data on the~     pharmacokinetics of BI 671800.~   "
188033|NCT01103336|"~     Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The~     purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous~     nicorandil on the incidence of contrast-induced nephropathy in patients with renal~     insufficiency undergoing coronary angiography.~   "
188034|NCT01103323|"~     This is a randomized, double-blind, placebo-controlled multi-center phase III study to~     evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer~     (CRC) who have progressed on/after all approved drugs for CRC~   "
188035|NCT01103310|"~     Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)~     images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or~     inflammation.~   "
188036|NCT01103297|"~     The purpose of this study is to is to evaluate the postoperative loss of reduction rate in~     patients with distal radius fractures treated using the 2.4 mm Variable Angle LCP Two-Column~     Volar Distal Radius Plate ®.~   "
188037|NCT01103284|"~     This study will look at the treatment effect of DiaPep277 on preservation of beta-cell~     function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that~     changes the way the immune system behaves, stopping its attack on the beta-cells.~      Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10~     injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.~   "
188038|NCT01103271|"~     Placebo pills (pills with no active ingredients) have been shown in research studies to~     somehow produce self-healing processes. The purpose of this study is to determine whether~     people will be willing to enter an open-label non-deceptive placebo treatment for Major~     Depressive Disorder (MDD) and whether open-label placebo can be effective for treating MDD in~     the context of a supportive physician-patient relationship.~   "
188039|NCT01103258|"~     Varicose vein disease is a common health problem, which causes much discomfort to patients.~      Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided~     foam sclerotherapy. These are two equally accepted and applied treatments for the same~     patient population.~      Choice of treatment often depends on the referral preference of the General Practitioner.~     Until now data are missing which treatment is more cost effective. The current proposal aims~     at comparing the effects, costs and patient preferences between duplex guided foam~     sclerotherapy and surgery in the treatment of greater varicose veins.~   "
188040|NCT01103245|"~     The purpose of this study is to determine the effects of mineralocorticoid receptor (MR)~     antagonism and renin inhibition on glucose metabolism in humans.~   "
188098|NCT01102491|"~     The purposes of this study are to document the antiemetic efficacy of multimodal antiemetic~     protocol in patient after Total Knee Arthroplasty using regional anesthesia, midazolam &~     propofol, hydration & oxygen supplement, preemptive & multimodal contemporary pain management~     and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect on~     this protocol. We hypothesized that the incidence of Postoperative nausea and vomiting during~     multimodal antiemetic protocol would be lower than Apfel's expected postoperative nausea and~     vomiting incidence. It was also hypothesized that Ramosetron prophylaxis would provide~     additional antiemetic effect.~   "
188041|NCT01103232|"~     Previous studies well documented the impact of unilateral training of limb muscle on the~     untrained contralateral homologous muscle. The aim of this study is to evaluate whether the~     electrical muscle stimulation on the dominant wrist flexors for 6 weeks cause an increase in~     the muscle strength of the contralateral wrist extensors in healthy adult men.~      Ethical approval was obtained from Institutional Review Board. All participants were~     volunteers and provided written informed consent. Among young adult males working in our~     hospital, 30 subjects who voluntarily accepted to participate in this study were assessed for~     eligibility. Twenty three young-adult healthy males were included in this double-blind~     prospective study. These volunteers were randomized into two groups. In Electrical Muscle~     Stimulation (EMS) group, electrical muscle stimulation of the right wrist flexor muscles was~     applied; in Controls, transcutaneous electrical nerve stimulation was applied. Electrodes~     were placed over the flexor aspect of the right forearm in both groups. Electrical~     stimulation was applied for thirty sessions (one session a day, five days a week for six~     weeks) in both groups by the same researcher. Compex2 (Medicompex SA, Switzerland) was used~     for electrical stimulation. Isokinetic torque was measured in the right and left wrist~     flexors and extensors before and after trial. Isokinetic torque was measured in the right~     (trained) and left (untrained) forearm with the Cybex (Humac 2004/Norm) extremity-testing~     system.~   "
188042|NCT01103219|"~     The main purpose of this study is to evaluate the effect of increased supply of energy,~     protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and~     arachidonic acid on growth, brain maturation and cognitive function.~   "
188043|NCT01103206|"~     The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test~     using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy~     adults in whom the results of the test with cinacalcet will be compared with those of the~     standardized PTH suppression test with intravenous calcium loading; 2- a group of patients~     with proven primary hyperparathyroidism in whom the results of the test with cinacalcet will~     be compared with those obtained during the same test, in healthy controls.~   "
188044|NCT01103193|"~     patients are allocated to one of the two study groups.~      In both groups a mixture of 60% nitrous oxide and 40% oxygen is administered through a face~     mask. In the first group the patient receives a constant concentration of sevoflurane. In~     this group the remifentanil concentration will be injected via an intravenous line in a step~     up protocol. In the second group remifentanil is injected in a fixed rate and sevoflurane is~     administered in a step up concentration.~      During the study, at predefined times, we will assess different levels of sedation (OAA/S~     score) and the reaction on tetanic stimulation of the ulnar nerve, insertion of a laryngeal~     mask airway and laryngoscopy. In addition heart rate, SpO2 and capnography will be recorded~     continuously and non invasive bloodpressure will be recorded using a 1 minute interval time.~     Spectral entropy and BIS derived from the frontal EEG will be used to monitor clinical~     cerebral drug effect.~      The null hypothesis is that remifentanil lowers the concentration of sevoflurane dissolved in~     a mixture of 60% nitrous oxide and 40% oxygen to (1) tolerate a specific stimulation and to~     (2) obtain a certain electroencephalographic parameter value and vice versa. Additionally the~     results of this study will be compared with a former interaction study of the same study~     group that did not involve nitrous oxide, in order to depict the shift in the response~     surface evoked by nitrous oxide.~   "
188045|NCT01103180|"~     The goal of this study is to examine the effectiveness the selective serotonin reuptake~     inhibitor (SSRI) escitalopram (also known by the trade name Lexapro) in reducing desire to~     self-harm and actual self-harming among young adults with borderline personality disorder who~     are also currently depressed. Subjects will receive either escitalopram or placebo for eight~     weeks. During this time subjects will be make weekly visits to see the psychiatrist and~     record their thoughts and feelings several times each day using an electronic diary.~   "
188046|NCT01103167|"~     Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical~     management for maintaining normovolemia is needed.~      The investigators hypothesized that intervention of volume status with the body composition~     monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.~   "
188047|NCT01103154|"~     Carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study~     was undertaken to compare the effectiveness and complication rates of nadolol and isosorbide~     mononitrate (ISMN) with carvedilol in the prevention of rebleeding from esophageal varices.~   "
188048|NCT01103141|"~     FEMORIS is a marketing study approved by institutional review boards to compare the rates of~     complications found when using either the Micropuncture® needle introducer or a standard~     gauge-18 needle to access the groin blood vessels.~   "
188049|NCT01103128|"~     The primary aim of this study is to determine if mutations of BRCA1 and BRCA2 result in~     different precancerous pathways to pancreatic ductal adenocarcinoma (PDAC), as suggested in~     our validated mouse model. Genomic DNA will be isolated on normal tissue obtained from~     patients who underwent pancreatic resection for PDAC, intraductal papillary mucinous neoplasm~     (IPMN) or mucinous cystic neoplasm (MCN). Tissue will be examined for the three most common~     founder mutations in Ashkenazi Jews. In the cases in which BRCA1 or BRCA2 mutations are~     found, heterozygote normal and abnormal tissue will be examined to look for mutations in the~     other BRCA1 or BRCA2 allele. The interaction between other cancer causing genes with BRCA1/2~     will also be evaluated by comparing the sequences of the other genes in pre-cancerous~     lesions.~      We hypothesize that BRCA1- and BRCA2-mediated pancreatic ductal adenocarcinoma progresses~     through the PanIN route, as seen in both BRCA1 and BRCA2 murine models of pancreatic cancer.~     We further hypothesize that BRCA1 mutations may enable an additional pre- neoplastic pathway~     through MCN, and that IPMN may embody yet another pre- neoplastic pathway.~   "
188050|NCT01103115|"~     The purpose of this study is to determine whether Calcium and Vit D supplementation is~     effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS).~   "
188099|NCT01102478|"~     The objective of this study was to prove the bioequivalence of Losartan~     Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.~   "
188100|NCT01102465|"~     The objective of this study was to prove the bioequivalence of losartan~     potassium/hydrochlorothiazide 100/25 mg tablet under fed conditions.~   "
188101|NCT01102452|"~     To evaluate the result of PPB-R-203-02 based noodle and commercially available wet noodle on~     blood glucose control in 24 patients with diabetes for 2 days.~   "
188051|NCT01103102|"~     The purpose of this study is to explore the dose-response relationship of Iocide oral rinse~     in a clinical trial of gingivitis.~      Approximately sixty (60) otherwise healthy subjects having gingivitis will be randomized into~     the 3-month study to provide 40 total evaluable subjects (10 per group). Each study~     participant will have four visits: a screening visit up to 21 days before the beginning of~     the trial, a baseline visit at day 1, and visits at weeks 8 and 12. The duration of the~     dose/range study will be three months to facilitate compliance and ensure timely completion~     of the Phase II study.~      Three dose/regimens will be evaluated against a placebo control oral rinse. Indices for~     gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine~     the effect of the antimicrobial oral rinse on relative levels of biological markers of~     inflammation.~   "
188052|NCT01103089|"~     The purpose of the study is to determine patient characteristics from patients that have used~     Iressa for a period of minimal 3 years.~   "
188053|NCT01103076|"~     In this study, the investigators will evaluate whether CD4+ TCM producing effector cytokines~     can be distinguished on the basis of their expression of the IL-7 receptor alpha-chain~     (CD127). Using CD154 production as a marker of Ag-specific CD4+ T cells, the investigators~     will also test the hypothesis that the phenotype and function of TCM are influenced by the~     type of Ag they recognize. TCM specific for two cleared protein Ag, tetanus toxoïd (TT) and~     hepatitis B surface (HBs), inducing an early stage of CD4+ T cell differentiation will be~     compared to TCM specific for cytomegalovirus (CMV), a persistent virus inducing an advanced~     stage of CD4+ T cell differentiation.~      The primary endpoint is to demonstrate in uremic patients who will begin chronic HD and in~     patients already chronically hemodialyzed any improvement in CD4+ T cell function ex vivo and~     in vitro. These analyzes will focus on memory T-cell subsets (i.e. Th17 and Tregs population)~     using HCO membranes or polyamide dialyzers.~      The secondary endpoint is a clinical one, namely, to show any improvement in T cell response~     to HB and TT vaccination (blood antibody titers).~   "
188054|NCT01103063|"~     The primary objective is to establish superiority of AZCQ over SP in protective efficacy for~     IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.~   "
188055|NCT01103050|"~     This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic~     inflammation. The study will investigate the paradigm of multiple receptor antagonism in~     allergic disease by combining QAV680 with a second generation H1 histamine receptor~     antagonist to assess possible additive or synergistic anti-allergic effects of the two~     compound classes.~   "
188056|NCT01103037|"~     This study will assess the safety and efficacy of QAV680 in patients with mild to moderate~     asthma~   "
188057|NCT01103024|"~     The purpose of the extension study is to provide patients completing the 28-week core study~     with an opportunity to receive an additional 22 weeks of continuous treatment.~   "
188058|NCT01103011|"~     The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and~     therefore the levodopa area-under-the-concentration-curve values, half-life, and trough~     concentrations The study will help determining the safety and tolerability of ND0611 and~     determine the pharmacokinetic profile of levodopa following multiple oral dosing of~     levodopa/carbidopa (LD/CD) and continuous delivery of ND0611~   "
188059|NCT01102998|"~     Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime~     sleepiness. However, very little data are available regarding the specific sleep disturbances~     of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5~     years from diagnosis and at least 2 years post treatment or observation only for a brain~     tumor will be targeted to assess the prevalence of sleep complaints.~      The study focuses on the following objectives:~        -  To estimate sleep disturbance in a cohort of pediatric brain tumor survivors.~        -  Estimate the rates of parent- and self-reported excessive daytime sleepiness in~          pediatric brain tumors~        -  Estimate the rates of parent-reported sleep-disordered breathing, including snoring and~          witnessed apneas, in pediatric brain tumor survivors~        -  Estimate the rates of parent- and self-reported behavioral sleep problems, including~          nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in~          pediatric brain tumor survivors.~      The Study focuses on the following secondary objectives:~        -  To describe bedtime patterns and sleep hygiene of pediatric brain tumor survivors.~        -  Estimate the typical parent- and self-reported weekday sleep duration of pediatric brain~          tumor survivors~        -  Estimate the typical parent- and self-reported weekend sleep duration of pediatric brain~          tumor survivors and if it differs from the weekday sleep duration~        -  Estimate the typical parent- and self-reported consistency of sleep hygiene in pediatric~          brain tumor survivors~   "
188060|NCT01102985|"~     The purpose of the study is to evaluate the effect of an aerobic-resistance exercise program~     compared to a home based physical activity program on bone mass, body composition, metabolic~     risk factors and cardiovascular fitness in women with cancer who have completed therapy.~   "
188061|NCT01102972|"~     This study is designed to compare the efficacy and safety of simplifying therapy from a~     regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a~     regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically~     suppressed, HIV-1 infected, HLA-B*5701 negative subjects for 48 weeks.~   "
188062|NCT01102959|"~     The hypothesis of this study focuses on obtaining accurate information on the effectiveness~     of photographic educational material on orientation of carbohydrate counting for adolescents~     with diabetes.~   "
188063|NCT01102946|"~     The purpose of this study is to evaluate the effects of panretinal photocoagulation plus~     intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic~     retinopathy in terms of changes in visual acuity and neovascularization area.~   "
188064|NCT01102933|"~     The study is an open, single center, observational study at the Cardiology Dept at Uppsala~     University Hospital. The number of patients included will be 410. The objectives are to:~      Evaluate biomarkers and change of these related to myocardial infarction, during two years~     follow-up in an unselected patient population with a recent myocardial infarction.~      Evaluate if an early change of biomarkers can be related to death, new myocardial infarction,~     and ischemic stroke in the same population after two and five years follow-up.~   "
188102|NCT01102439|"~     This study will explore the effect of different doses of aspirin on the effects of~     double-dose or standard dose clopidogrel.~   "
188065|NCT01102920|"~     The primary aim is to study whether a tailored behavioural medicine intervention addressing~     physical activity and eating habits have additional effects to continuous positive airways~     pressure (CPAP) in patients with moderate or severe obstructive sleep apnea syndrome (OSAS)~     combined with obesity. Direct everyday life consequences (see below) of OSAS are studied, as~     well as cognitive functions and ventilatory parameters. Long-term benefits will be examined~     in terms of quality of life and everyday life activity. Another aim is to study mechanisms of~     treatment effects, if any.~      The specific goals are:~        1. To study changes in OSAS ventilatory parameters following a tailored behavioural~          medicine intervention addressing physical activity and eating habits (including CPAP)~          compared to regular CPAP-treatment~        2. To study immediate and long-term effects on daytime sleepiness, attention and~          concentration, everyday life activity, quality of life following a tailored behavioural~          medicine intervention addressing physical activity and eating habits (including CPAP)~          compared to regular CPAP-treatment~        3. To study associations of changes in metabolic parameters and systemic inflammation and~          physical activity level and adherence to CPAP-regimen respectively.~        4. To identify mediators, moderators, and predictors of treatment effects, if any.~   "
188066|NCT01102907|"~     Our objective is to determine whether food form (liquid vs. solid) alters gastric emptying,~     satiety, and food intake, when all macronutrients and fiber are controlled. The study~     population will include 10 healthy women, who have a normal body mass index. We have chosen~     to evaluate only women because this is a small pilot study and one of our endpoints is~     gastric emptying. Gastric emptying is known to differ between men and women. Gastric emptying~     will be evaluated using the Smartpill technology, satiety will be evaluated using~     computerized visual analog scales/questions, and food intake will be measured by providing~     subjects with an ad libitum/buffet-style lunch.~      Our hypothesis is that our subjects will be less hungry after they eat a solid breakfast~     compared to a liquid breakfast. We also hypothesize that our subjects will have a slower~     gastric emptying time after they eat the solid meal. Lastly, we think subjects will want to~     eat less food at lunch time if they have eaten a solid meal compared to a liquid meal for~     breakfast.~   "
188067|NCT01102894|"~     Research suggests dietary fiber may decrease transit time through the gastrointestinal tract.~     Research studies traditionally use radio-opaque markers to determine gastric emptying,~     colonic transit, and whole gut transit time. The SmartPill is a single use pill that can be~     used to determine gastric emptying, colonic transit, and whole gut transit time without~     requiring X-rays or fecal collections. Previous studies have found radio-opaque markers and~     the SmartPill detect the similar transit times.~      The purpose of this pilot study is to determine if the SmartPill can detect a change in~     transit time using a significant dose of dietary fiber.~   "
188068|NCT01102881|"~     Dietary fibers have previously been shown to affect laxation and satiety. Due to differences~     in structure and physical properties of dietary fibers, these effects may not be consistent~     across all fibers. Therefore as new dietary fibers are created or discovered the laxative and~     satiating effects should be investigated in order to verify these effects.~   "
188069|NCT01102868|"~     Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist,~     leading to paresthesias, numbness and muscle weakness in the hand. Treatment of the condition~     often involves surgery.~      In this study we wish to se if there is an effect of using intramuscular stimulation (IMS) to~     release the tension of nervus medianus in the lower arm. The study will be performed by~     randomization to IMS of musculus pronator teres or a control (Scam IMS treatment to the~     acupuncture point Li11). The two insertion points are approximately 1cm apart in the lower~     arm.~   "
188070|NCT01102855|"~     Purpose:~      The main objective of this study is to determine endomicroscopic features of Crohn´s disease.~      Background:~      Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the~     gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is~     based on several histologic features including transmural pattern of inflammation, crypt~     abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a~     valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an~     optical biopsy of the gastrointestinal mucosa during the endoscopic procedure.~      Scope:~      In patients with Crohn´s disease.~   "
188071|NCT01102842|"~     Laboratory studies have found that insufficient sleep duration and impaired sleep quality are~     associated with disease risk, including obesity, diabetes and heart disease. The limitation~     to the laboratory studies is that they are conducted in artificial environments that do not~     reflect real-world behavior. Although the epidemiologic studies do reflect habitual behavior,~     the vast majority of them rely on self-reported measures of sleep, which are only moderately~     correlated with objective measures of sleep.. The next logical step in the examination of~     sleep's role in cardiometabolic health is to conduct objective, detailed measures of sleep in~     people's homes. This project is a pilot study that will develop ideal methodologies for~     recording sleep in the home environment. Because there is currently is a gap between~     laboratory models of sleep loss and real world conditions, the ultimate goal of this research~     is to expand our work on sleep and cardiometabolic health outside of the laboratory. Given~     the strong evidence for a link between impaired and insufficient sleep and increased disease~     risk, it is critical that we understand how people sleep in their daily lives and what~     factors can impact sleep. This project will record sleep in people's homes using ambulatory~     polysomnography recordings and wrist actigraphy.~   "
188072|NCT01102829|"~     The aim of this study is to accurately assess the relationship between knee joint kinematics~     and migration of the tibial component of a high congruent, rotating platform total knee~     prosthesis by using fluoroscopy synchronised in time and space with a force plate, an~     external motion registration system and Electromyography (EMG).~   "
188073|NCT01102816|"~     The purpose of this study is to determine the feasibility, effectiveness and safety of~     acupuncture for pain management in hemodialysis patients.~   "
188074|NCT01102803|"~     The purpose of this study is to investigate the utility of post-session administration of~     D-cycloserine to enhance fear extinction in a sample of people with acrophobia who will be~     treated with CBT.~   "
188075|NCT01102790|"~     The purpose of this study is to determine the HIT-antibody generation without prior~     heparin-exposure in patients undergoing orthopedic surgery.~   "
188076|NCT01102777|"~     The purpose of this study is to assess the efficacy of an internet-mediated pedometer based~     intervention that is designed to increase walking and improve function among veterans with~     chronic obstructive pulmonary disease (COPD). The Specific Aims are: 1) to test the~     effectiveness of an automated internet-mediated walking program for veterans with COPD with a~     primary outcome of improvement in health-related quality of life at four-months and at one~     year in a randomized controlled trial (RCT) with a wait list control. 2) to estimate the~     effect of internet-mediated walking program for veterans with COPD on all cause days of~     hospitalization over one year following randomization. 3) to compare intervention reach,~     participation and satisfaction outcomes between rural and urban veterans among those~     randomized to the intervention arm. The long-term objective of this research is to develop,~     evaluate and disseminate effective, low-cost interventions that improve quality of life for~     veterans, particularly rural veterans, managing complex chronic conditions.~   "
188077|NCT01102764|"~     The present proposal is to study whether Prolonged Exposure (PE) delivered via Telemedicine~     is as effective as PE delivered In Person for Operation Iraqi Freedom (OIF), Operation~     Enduring Freedom (OEF) Veterans and Veterans of all theatres, particularly Vietnam era with~     Post-Traumatic Stress Disorder (PTSD). ).~   "
188078|NCT01102751|"~     We aimed to determine the effect of vitamin D replacement therapy on serum FGF-23~     concentrations in vitamin D deficient women and to compare the FGF-23 concentrations of~     vitamin D deficient patients with healthy subjects and patients with genetically-determined~     hypophosphatemic rickets.~   "
188079|NCT01102738|"~     Highly premature infants are susceptible to serious infections such as necrotizing~     enterocolitis (NEC) and late-onset blood stream infections (BSIs).~      NEC is a poorly understood, potentially life-threatening bowel disorder. It is thought that~     bacteria proliferating abnormally in the bowel may play an important part in its cause, but~     no single pathogen has yet been identified.~      BSIs are commonly caused by gut bacteria. As the highly premature gut is fragile and has~     increased permeability, poor motility and decreased immune defences, localised inflammation~     caused by abnormal bacterial growth may allow 'bystander' microbes to translocate through the~     gut into the blood stream leading to systemic infection.~      The investigators will collect daily faecal samples from premature (<32 weeks) infants in the~     intensive care unit from the day of birth until they are discharged. By using newly developed~     molecular detection techniques the investigators aim to define more precisely than has ever~     previously been attempted, all the species of bacteria present in the faeces. This will~     enable comparison of the pre-morbid and post-morbid intestinal microbiota (all the bacteria~     in the gut) in premature neonates.~      In a small proportion of infants who develop NEC, surgery will be required as part of~     treatment of the condition. In these infants the investigators will seek consent to collect a~     small part of the diseased bowel which has been removed. Similar analysis will be performed~     on these samples. The analysis of the tissue samples will give us an indication of how well~     the faeces act as a proxy for the intestinal microbiota.~      In this ecological study of the evolution of the intestinal microbiota in preterm infants, by~     comparing samples from babies who develop NEC or late-onset BSI with those of well babies the~     investigators will be able to look for differences characteristic of the conditions. This~     information will help aid design of prevention or treatment strategies.~   "
188080|NCT01102725|"~     The purpose of this study is to determine:~        1. What quantity of bacteria is spilled into the abdomen during a colon resection~        2. If there is a correlation between the quantity and post-operative infection~        3. What intralumenal pressure is generated when testing the colonic anastomosis for air~          leak~   "
188081|NCT01102712|"~     To establish and confirm the safety and clinical utility of BTVA applied unilaterally for~     lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.~   "
188082|NCT01102699|"~     Diabetes mellitus is associated with a significant reduction of circulating progenitor cells~     (CPCs). These include endothelial progenitor cells (EPCs), which are involved in~     cardiovascular homeostasis and repair. A reduction of CPCs in metabolic patients is~     associated with an increased risk of future adverse cardiovascular outcomes. Therefore, ways~     to active stimulate an increase of CPC levels in diabetes are actively pursued.~      Experimental animal studies and preliminary data in humans indicate that a bone marrow defect~     is causally related to the low CPC level in diabetes.~      Our previous data in rats indicate that diabetes reduces the bone marrow responsiveness to~     granulocyte colony-stimulating factor (G-CSF) in terms of progenitor cell mobilization.~      In the present study, we aim at investigating bone marrow responsiveness to pharmacological~     mobilization of CPC in diabetic patients as compared to non-diabetic subjects.~   "
188083|NCT01102686|"~     The objectives of this clinical trial are to assess the safety and tolerability, as well as~     efficacy, of a stepwise dosing regimen of pyrimethamine, starting at 25 mg/day, given as a~     single dose daily for 4 weeks in patients affected with chronic Tay-Sachs or Sandhoff~     variants.~   "
188084|NCT01102673|"~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK)~     and preliminary food effect of PF-04991532 following single escalating oral doses in healthy~     adult subjects.~   "
188085|NCT01102660|"~     PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain~     signalling following nerve injury and inflammation. Blocking such mediators may potentially~     have a therapeutic benefit by reducing pain.~   "
188086|NCT01102647|"~     The purpose of the study is to examine the effect of plant sterols on cholesterol absorption~     and synthesis in people with heterozygous phytosterolemia.~   "
188087|NCT01102634|"~     The study aims to investigate the effect of Acu-TENS on post-exercise blood lactate level and~     EPOC~   "
188088|NCT01102621|"~     Hypothesis: Treatment for head and neck tumors often involve methods that affect the auditory~     system and cause hearing loss. Neck dissection negatively impacts the lymphatic drainage,~     chemotherapy uses ototoxic drugs, radiotherapy affects blood flow and tissue radiation is~     toxic to the ear and may lead to hearing losses of various types and degrees.~      Objective: To investigate occurrences of hearing loss and complaints among patients with head~     and neck tumors who underwent radiotherapy.~      Study design: Prospective, case-control study. Setting: Tertiary care center hospital.~      Subjects and Methods: 282 subjects were evaluated, 141 with head and neck tumors and 141 as~     an age-matched control group. The controls had never undergone oncological treatment that put~     their hearing at risk. All subjects underwent audiological evaluation, including the HHIE~     questionnaire, pure tone audiometry, speech audiometry and immittance audiometry. The~     radiation dose received by the auditory system was calculated based on the percentage of the~     external auditory canal included in the radiation field.~   "
188089|NCT01102608|"~     To study the activity and toxicity of a neoadjuvant regimen including high-dose ifosfamide in~     combination with radiotherapy, and subsequent surgery, in high-risk soft tissue sarcomas.~   "
188090|NCT01102595|"~     In the last 20 years, only temozolomide has obtained indication for the treatment of~     High-grade glioma (HGG). Temozolomide during and later radiation therapy has doubled one year~     survival and is the standard treatment for glioblastoma. But 30% of glioblastomas receive~     only a biopsy as they can't be resected and don't get benefit from this treatment. They and~     should be treated immediately after the biopsy to prevent neurological deterioration but in~     spite of this approach they often deteriorate neurologically during radiotherapy. . An~     effective pre-radiation treatment should improve their prognosis and allow them to complete~     concomitant radiotherapy and temozolomide treatment. Bevacizumab in recurrent HGG displays~     63% of objective responses when combined with irinotecan. But irinotecan is not the most~     active treatment in this disease.~      We propose a phase II, two arms, open label, randomized, multicentric study with 2 cycles of~     temozolomide before radiation therapy and concomitant temozolomide, in patients with~     glioblastoma and 'biopsy-only'. Bevacizumab will be added to one arm.~   "
188091|NCT01102582|"~     -  Dementia correlates to decreased cognitive function, and Behavioral and Psychological~          Symptoms of Dementia (Neuropsychiatric symptom, BPSD) as well.~        -  Neuropsychiatric symptom attributes important role for mortality, mortality, and cause~          to enter nursing home.~        -  Study on neuropsychiatric symptom in patients with Parkinson's disease has not been~          thorough yet, and there even has not been any study done on this in Korea yet.~        -  The investigators will study prevalence of neuropsychiatric symptom in PDD patients and~          burden of caregiver.~   "
188092|NCT01102569|"~     The aim of this study is to determine the frequency of the three most common BRCA1 and BRCA2~     genetic mutations that are commonly found in Ashkenazi Jewish patients with pancreatic~     cancer. Testing for BRCA1 and BRCA2 mutations in relatives of hereditary pancreatic cancer~     patients may have a significant impact; allowing for early screening, treatment, and~     resection of pre-malignant tissue or malignant lesions.~   "
188093|NCT01102556|"~     The specific aims of this project are to create a registry, as well as a biospecimen bank for~     individuals with pancreatic disease (e.g. pancreatic adenocarcinoma, pancreatitis,~     intraductal papillary mucinous neoplasm (IPMN) mucinous cystic neoplasm (MCN), and pancreatic~     intraepithelial neoplasia (PanIN) or have been determined to be at high-risk for pancreatic~     cancer. Biospecimen can be defined as blood, urine, tissue, stool, or saliva samples.~     Therefore, no hypothesis is to be tested. The personal data derived from the registry,~     correlated with biological information derived from the biospecimens will allow for future~     investigative studies of pancreatic cancer etiology and tumor biology. The long-term goals of~     the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer.~     It is anticipated that the knowledge derived will ultimately lead to improvements in the~     diagnosis, prevention, detection,and treatment of pancreatic cancer.~   "
188094|NCT01102543|"~     The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32~     weeks) in real life situation and the management of RDS.~   "
188095|NCT01102530|"~     The objective of this research is to conduct focus groups in order to adapt the Diabetes~     Prevention Program (DPP) so that it may successfully target women diagnosed with gestational~     diabetes (GDM) who are at high risk for developing Type 2 diabetes in the post-partum period.~     As this research seeks to gather formative data for a future intervention, the focus groups~     will: 1) provide information to maximize participation in the future intervention and 2)~     inform the location, content and format of the intervention.~      We will be conducting focus groups and informant interviews to determine the DPP~     modifications necessary for adapting to the post-partum lifestyles of women with a recent~     history of GDM. Subjects will attend a 1 hour focus group or phone interview where they will~     be encouraged to respond to the facilitators' questions and to each other's comments on~     topics such as: gestational diabetes, healthy eating, exercise, and other type 2 diabetes~     prevention related activities. Working with a variety of health care providers, including~     endocrinologists, obstetricians and nurse-practitioners, we will identify and enroll up to 60~     women total who are either current GDM patients at BWH or have a recent history of GDM who~     have delivered at Brigham and Women's Hospital in the last 5 years.~   "
188096|NCT01102517|"~     The purpose of this study is to establish the effects of VATS lobectomy for early-stage~     non-small cell lung cancer.~      The aims of this study are:~        1. To evaluate the early clinical benefits of VATS lobectomy when compared with the~          axillary thoracotomy.~        2. To evaluate the late effects of VATS lobectomy on survival and quality of life when~          compared with axillary thoracotomy.~        3. To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung~          cancer.~        4. To explore the indication of VATS lobectomy for the lung cancer.~   "
188097|NCT01102504|"~     Stroke is the second leading cause of death worldwide. One of the causes of stroke which can~     be treated is narrowing of the carotid artery. Currently the only definite treatment option~     is surgery or endovascular treatment. All patients not qualified for or awaiting surgery are,~     therefore, left with best medical therapy and with a yearly risk of stroke anywhere between~     1% - 35% depending on the severity of the disease.~      The study will use the properties of a tomato extract containing lycopene. Previously studies~     have demonstrated beneficial properties of tomato extracts:~        1. It decreases lipid oxidation~        2. It decreases DNA damage~        3. It has properties that reduce the speed and amount of cell divisions that inflammatory~          and smooth muscle cells undergo (both of these cell types contribute to atheroma~          formation).~      The investigators wish to assess whether long-term food supplementation with a tomato extract~     containing lycopene could influence atherosclerotic plaque characteristics. The investigators~     will assess this using Magnetic Resonance Imaging of the plaque and transcranial Doppler~     ultrasonography for counting the number of blood clots that go to the brain's arteries.~     Furthermore the investigators wish to examine the effect of long-term food supplementation~     with a tomato extract containing lycopene on blood cholesterol levels and lipid oxidation and~     blood markers of inflammation and injury of the inner lining of the arteries.~      This will be a single center, double blind, randomised, placebo controlled study.~   "
188103|NCT01102426|"~     Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients~     with relapsed/refractory multiple myeloma.~   "
188104|NCT01102413|"~     The study is designed to determine the effects of an investigational drug Monofer in subjects~     with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron~     deficiency anaemia (IDA).~   "
188108|NCT01102361|"~     The objective of the study is to examine the effectiveness and accuracy of the BioXbot in~     prostate biopsy as opposed to transrectal biopsy. This evaluation of the efficacy of both the~     procedures is based on:~        -  Uptake rate~        -  Peripheral zone reachability~        -  Needling accuracy~        -  Procedure execution time~        -  Post operative discomfort or trauma experienced by patient~        -  Quality and type of tissue sample extracted~        -  Adverse and unanticipated side-effects on patient after the procedure and recording any~          unexpected reactions~   "
188109|NCT01102348|"~     The purpose of this pilot study is to assess the feasibility, acceptability, and safety of a~     new feeding protocol, The Enhanced Protein-Energy Provision via the Enteral Route in~     Critically Ill Patients: The PEP uP protocol.~   "
188110|NCT01102335|"~     The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on~     safety and survival of HCC patient after transcatheter arterial chemoembolization.~   "
188111|NCT01102322|"~     In 1967, Ashbaugh et al first described 12 patients with a syndrome characterized by the~     acute onset dyspnea, severe hypoxemia, diffuse lung infiltrates on the chest radiography and~     decreased lung compliance. Moreover, in 1988, Murray et al proposed a lung injury scoring~     system based on the level of positive end-expiratory pressure (PEEP), PaO2-to-FiO2 ratio,~     static lung compliance, degree of infiltrates on the chest radiograph, and clinical cause. A~     score of 2.5 or greater was considered to be consistent with a diagnosis of ARDS. The current~     definition of ARDS was proposed by Bernard et al and the American-European Consensus~     Conference in 1994. The criteria of ARDS included: 1) acute onset; 2) a PaO2/FIO2 ratio, or~     hypoxia score, of < 200, regardless of positive endexpiratory pressure; 3) bilateral~     infiltrates on chest radiograph; and 4) a pulmonary artery occlusion pressure of <18 mm Hg or~     the absence of clinical evidence of left atrial hypertension.~      However, despite advances in ventilator management, the mortality rate of acute lung injury~     and the acute respiratory distress syndrome remains very high (approximately 40 to 50~     percent). In 2000, ARDS Network trial compared the effects of 6 versus 12 mL/kg of tidal~     volume per predicted body weight (PBW) among 861 patients and noted an overall 22% reduction~     in mortality rate, more ventilator-free days, and more organ-failure-free days in the~     low-tidal-volume group. Therefore, the current approach to mechanical ventilation of a~     patient with ARDS emphasizes the use of lower tidal volumes with lower pressures to avoid~     causing lung overdistension and ventilator associated lung injury.~      Nevertheless, one year after publication of the ARDSnet trial, Rubenfeld et al noted that~     lung-protective ventilation strategies were applied in less than 5% of patients with ARDS or~     ALI at a single ARDSnet center. Rubenfeld et al found that common barriers to the initiation~     of low tidal volume ventilation include unwillingness to relinquish control of the~     ventilator, failure to recognize patients as having ALI/ARDS, and perceived contraindications~     to low tidal volume ventilation. Significant barriers to the continuation of low tidal volume~     ventilation include concerns regarding patient discomfort and tachypnea or hypercapnia and~     acidosis.~      In addition, Kalhan et al also evaluated factors associated with the choice of tidal volume~     and he reported that underuse of LPV may be related to clinicians' under-recognition of less~     severe cases of ALI, and their reserving of low-tidal volume ventilation for more severe~     cases, or both. However, the factors such as comorbidity and pathophysiological change~     associated with underuse of lung protective ventilation strategy are not clear. The~     investigators perform a prospective single-center study to investigate the factors associated~     with the use of lung protective ventilation strategy (LPV) in ALI/ARDS patients in ICU.~   "
188112|NCT01102309|"~     The goal of this study is to determine if robot aided rehabilitation therapy can be~     equivalent to or more effective than conventional rehabilitation therapy at promoting~     functional recovery of the paretic upper limb in acute and subacute stroke patients.~   "
188113|NCT01102296|"~     Male homosexuals are at risk for hepatitis A virus (HAV) infection, and HAV vaccination has~     been recommended to prevent HAV infection in male homosexuals. HIV infection may impair~     serological responses to HAV vaccination in HIV-infected patients. The investigators~     hypothesize that 3 doses of HAV vaccine will improve serological responses to HAV vaccine in~     HIV-infected patients.~   "
188114|NCT01102283|"~     The objective of this registry is to compile clinical data on the use of the Evolution®~     Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused~     by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in~     patients with malignant strictures.~   "
188115|NCT01102270|"~     The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the~     breathing effort required to briefly wake people with obstructive sleep apnea from sleep~     (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the~     severity of obstructive sleep apnea in some people (those that have a low respiratory arousal~     threshold; i.e. wake up easily to respiratory stimuli).~   "
188116|NCT01102257|"~     The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty~     acids in treating dry eye disease. The study is termed feasibility because its purpose is~     to demonstrate an ability to execute the proposed protocol with compliance at two sites~     rather than generate statistically relevant data concerning the safety and efficacy of the~     supplement in patients with dry eye disease.~   "
188117|NCT01102244|"~     The purpose of this study is to evaluate the clinical efficacy and safety of Tobradex ST~     compared to AzaSite in the treatment of moderate to severe chronic blepharitis.~   "
188118|NCT01102231|"~     Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell~     lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising~     association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.~   "
188119|NCT01102218|"~     Chronic kidney disease (CKD) patients have increased levels of inflammation and oxidative~     stress, which in turn contribute to anemia and cardiovascular disease.~      Pentoxifylline is known to have anti-inflammatory and anti-oxidant properties, and has shown~     promise in improving the treatment of patients with anemia. This study will examine the use~     of pentoxifylline for the treatment of anemia in chronic kidney disease.~   "
188120|NCT01102205|"~     Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in~     subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of~     levothyroxine therapy on oxidative balance are also not known in hashimoto disease.~   "
188121|NCT01102192|"~     Although the association between thymic hyperplasia / thymoma and autoimmune myasthenia~     gravis has been known for some time, the question of causality remains uncertain. Recent~     research findings indicate, however, that especially in myasthenia patients with thymomas a~     non-physiological export of naive CD4 + T-cells can take place by the tumour and this could~     possibly play an important role in the pathogenesis of myasthenia gravis. The investigators~     want to analyse the functionality and specificity of t-cells generated in thymomas as well as~     the effect of thymectomy on the immune system.~   "
188134|NCT01102023|"~     High sodium intake causes hypertension. Various efforts for reducing salt consumption are~     proceeding all over the world. Solar salt contains reduced sodium and abundant mineral, such~     as calcium, potassium, and magnesium, comparing to ordinary salt. Use of solar salt, instead~     of ordinary salt, may have beneficial effects to blood pressure.~      The investigators are going to conduct a preliminary study that can support antihypertensive~     effect of solar salt intake.~   "
188122|NCT01102179|"~     Vitamin D insufficiency and deficiency is common in chronic kidney disease (CKD) patients and~     is associated with elevated parathyroid hormone (PTH) concentration and mineral and bone~     disorder (MBD). There is also increasing evidence to show that these abnormalities increase~     cardiovascular morbidity and mortality in CKD patients. There is a need for early~     identification of vitamin D insufficiency/deficiency in CKD patients to prevent its long-term~     complications. However, the vitamin D status of CKD patients in Singapore has not been well~     described. The purpose of this study is to assess the vitamin D status of predialysis CKD~     patients in a tertiary academic teaching hospital in Singapore, and its association with~     parameters for MBD. Predialysis patients from the outpatient renal clinic at the National~     University Hospital (NUH) will be recruited into this study. Blood samples from the patients~     will be collected after an overnight fast to determine their serum 25(OH)D, creatinine,~     phosphorus, calcium, albumin and i-PTH concentrations. These parameters will be compared~     among patients in various stages of CKD.~   "
188123|NCT01102166|"~     Background:~      Devices used to facilitate mucus mobilization have been target of several controversies and~     mainly a few scientific studies that endorse the use of those equipments. According to the~     principle of acapella® device, it should be used concomitant with nebulization aiming to~     optimize its performance in bronchial hygiene.~      Aims: To assess the effect of acapella® device application in the radioaerosol regional~     pulmonary deposition through pulmonary scintigraphy in normal subjects.~      Materials and method: 10 health individuals, males and mean age of 24,4 ± 2,2 years~     participated in this study during the three phases of this research: 1st phase were done with~     nebulization through acapella® device, attached in the final branch according to manufacturer~     recommendation; in 2nd phase a ¨T¨tube connector were adapted, being nebulizer attached to~     the mouthpiece and in 3rd phase nebulization were performance through the mouthpiece as~     routinely used in aerosoltherapy.~   "
188124|NCT01102153|"~     Sudden cardiac death remains one of the major leading causes of death. Therapeutic~     hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after~     cardiac arrest. To assess the efficiency of different cooling methods and further improve~     these methods, the investigators collected blood samples to measure the neuron specific~     enolase (NSE) in patients treated with invasive cooling as compared to patients treated with~     non-invasive cooling.~   "
188125|NCT01102140|"~     This blinded, controlled study will examine the impact of pomegranate polyphenol extract~     (POMx, from Pom Wonderful, LLC), 1000mg on cardiomyopathy in subjects with chronic renal~     insufficiency.~   "
188126|NCT01102127|"~     Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule~     assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign~     nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity~     using sonography, as malignancy is related to stiffness of solid organs. The investigators~     have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter.~     Consecutive patients will be assessed using US, FNA and elastography; the latter will be~     compared with cytology. Specificity, sensitivity, and predictive values will be calculated.~   "
188127|NCT01102114|"~     The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term~     abstinence.~   "
188128|NCT01102101|"~     Postherpetic neuralgia (PHN) is often associated with pain and sensory changes and is the~     leading type of neuropathic pain in modern clinical pain research. It is characterized by a~     variety of sensory patterns, which may be categorized into irritable nociceptor and~     impairment of nociceptor. At date, several lines of evidence lead to the assumption, that~     mechanical hyperalgesia in PHN is based - at least in part - on central nervous processes of~     sensitization.~      In animal studies the investigators have discovered a previously unrecognized effect of~     opioids, the reversal of long-term potentiation (LTP) at C-fibre synapses, i.e. an~     opioid-induced depotentiation. In principle, synaptic depotentiation may be permanent or~     transient. In our study the clinically used ultra-short acting MOR agonist remifentanil~     normalized synaptic strength after wash-out of the drug. At present it is not known whether~     opioid-induced depotentiation can be used to the benefit of pain patients.~      The aim is to study the hypothesis, that pain in a group of PHN patients with predominant~     mechanical hyperalgesia is reversed by intravenous remifentanil at a plasma target~     concentration of 18ng/ml (corresponding to about 0.75 µg/kg/min) for 60 minutes compared with~     PHN patients of other sensory types.~   "
188129|NCT01102088|"~     The goal of this clinical research study is to find the highest tolerable dose of radiation~     that can be given in combination with chemotherapy in patients with esophageal cancer that~     cannot be removed by surgery.~   "
188130|NCT01102075|"~     The purpose of this study is to determine whether electroacupuncture is effective on waist~     circumference in obesity.~   "
188131|NCT01102062|"~     Human urinary metabolic profiling showed to be very successful to elucidate biomarkers linked~     to geographic origin and specific food consumption patterns (Holmes and Loo et al.: Human~     metabolic phenotype diversity and its association with diet and blood pressure. Nature~     2008:1-6). It was possible to identify urinary metabolites directly linked to animal vs.~     vegetable protein intake. This is very valuable for future population studies, where diet is~     an important lifestyle factor but food questionnaires are time-consuming and expensive.~     Moreover, miss-reporting is a very common problem.~      Our hypothesis is to find the same biochemical marker for orange juice as we already found in~     a preceding nutritional studies where participants recorded orange consumption.~   "
188132|NCT01102049|"~     Many population studies include food questionnaires (recording the normal food intake or the~     food intake of the study day). This is necessary, because diet is an important lifestyle~     factor, although food questionnaires are time-consuming and expensive. Moreover,~     mis-reporting is a very common problem. We therefore seek for a tool to validate food~     protocol.~      The hypothesis is to find biochemical marker for animal protein, fruit intake and grape~     consumption in urinary metabolic profiles after specific food consumption. Furthermore we~     want to specify biomarkers for different animal protein sources, fish and beef.~   "
188133|NCT01102036|"~     The aim of this study is to determine the effect of cultura yoghurt on transit time and~     digestive discomfort during 2 weeks of treatment in comparison to placebo in healthy women~     and men.~   "
188135|NCT01102010|"~     Elderly with hip fractures are often frail and discharged from hospital after few days of~     hospitalisation. Hip fracture surgery is often associated with blood loss, where the patient~     is at risk of developing anaemia. Low haemoglobin level reduces the body's oxygen transport~     which causes impaired functional ability and strain on vital organs. Acute anaemia is worse~     tolerated in elderly, than in younger patients. Therefore this study aims to investigate~     whether there are effects of an expanded indication for blood transfusion in the frail~     elderly.~   "
188136|NCT01101997|"~     This study is being performed to reduce unwanted abdominal fat using a new applicator for the~     Zeltiq System.~   "
188137|NCT01101984|"~     Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated~     in comparison with sodium hyaluronate ophthalmic solution.~   "
188138|NCT01101971|"~     Objective: To evaluate the effectiveness of a web based learning module in the preparation of~     medical students to undertake a first female pelvic exam.~      Background: Bryden Magee (Meds 2010) under the supervision of Robert Reid, M.D., created an~     educational DVD © 2009 that gives a step-by-step approach to the pelvic exam utilizing real~     patient video clips and illustrations. Endorsed by the Association of Professors of~     Obstetrics and Gynaecology of Canada (APOG), this educational innovation has been shown to~     improve both knowledge and confidence in medical students learning these skills (Magee 2009).~     The video content is accessible to all Queen's faculty and students affiliated with the~     School of Medicine through MEdTech.~      Methods: We will introduce medical students to the MEdTech pelvic exam module and use a~     comprehensive assessment tool, designed by experienced gynaecologists in our Department, to~     measure how well they perform their first exam on female volunteers acting as mock patients.~     We plan to recruit 48 students and 4 mock patients.~      Outcome: We will evaluate the success rate of students achieving a passing grade of 50%~     (12/24) on their first unassisted speculum and bimanual examination after viewing the video~     content.~   "
188139|NCT01101958|"~     Use of the Chartis® Assessment System prior to EBV Treatment~   "
188140|NCT01101945|"~     The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.~   "
188141|NCT01101932|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics (how the drug effects certain target sites of activity in the body) of~     escalating doses of oral PF-04308515 in healthy volunteers for 14 days as well as one oral~     dose of a tablet formulation administered for 1 day.~   "
188142|NCT01101919|"~     This study is designed to evaluate the levels of CP-690,550 in the blood of healthy Chinese~     subjects following both single doses and multiple doses of drug.~   "
188143|NCT01101906|"~     This is a randomized, placebo-controlled, double-blind phase 2 study of OSI-906 or placebo at~     a continuous 150 mg twice daily (BID) dose.~   "
188144|NCT01101893|"~     In this study, approximately 16 subjects will receive raltegravir 400mg twice daily for 5~     days (Treatment A) followed by a washout period. In Period 2, subjects will receive~     GSK2248761 200mg once daily for 5 days (Treatment B). There will be no wash out between~     Period 2 and 3. Subjects will then be administered raltegravir 400mg twice daily in~     combination with GSK2248761 200mg once daily (Treatment C) for 5 days. Subjects will be~     housed in the unit for the duration of the study. Safety evaluations and serial PK samples~     will be collected during each treatment period. A follow-up visit will occur 7-14 days after~     the last dose of study drug.~   "
188145|NCT01101880|"~     This phase II trial is studying how well giving clofarabine and cytarabine together with~     filgrastim works in treating patients with newly diagnosed acute myeloid leukemia (AML),~     advanced myelodysplastic syndrome (MDS), and/or advanced myeloproliferative neoplasm. Drugs~     used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     the drugs in different doses may kill more cancer cells. Colony stimulating factors, such as~     filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood~     and may help the immune system recover from the side effects of chemotherapy.~   "
188146|NCT01101867|"~     The purpose of this study is to determine whether mealtime insulin results in better control~     of blood sugar than a fixed meal dose in hospitalized patients.~   "
188147|NCT01101854|"~     This study has two arms: 1) the biopsy arm and 2) the debridement arm. The purpose of the~     biopsy arm is to determine whether there are similar patterns of genes being turned on and/or~     turned off among people with healing and non-healing wounds. The purpose of the debridement~     arm is to (i) identify the nature of bacterial infection and the genes driving the tissue~     response to it; and (ii) determine how the biofilm components arrest/paralyze the immune~     function.~   "
188148|NCT01101841|"~     To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for~     treatment of vasomotor symptoms (VMS) associated with menopause~   "
188149|NCT01101828|"~     The purpose of this study is to compare methods for transporting self-collected swabs for HPV~     testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year~     old women.~   "
188150|NCT01101815|"~     This study will obtain pilot data on the impact oral naltrexone 50 mg/day vs. a~     sustained-release naltrexone implant on response to antiretroviral therapy (ART) in opioid~     addicted patients beginning ART in St. Petersburg, Russia.~   "
188151|NCT01101802|"~     Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis.~     Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow~     mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD~     in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug~     mycophenolate mofetil (MMF).~   "
188152|NCT01101789|"~     This is a prospective randomized multicenter study which purpose is to determine whether~     triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the~     incidence of surgical wound infections.~   "
188162|NCT01101659|"~     The objective of this study is to investigate whether JNJ-40411813 versus placebo reduces~     psychosis-like symptoms, induced by infusion of a low dose of ketamine. Effects of~     JNJ-40411813 on ketamine-induced symptoms will be evaluated about 3 hours after a single oral~     dose when the concentration of JNJ-40411813 in the blood is at its maximum and up to 24 hours~     after dose administration to assess the duration of a potential JNJ-40411813 effect.~   "
188153|NCT01101776|"~     This observational multicentric study is planned to assess the tolerability of Rebif New~     Formulation in an Australian clinical setting by the incidence of injection site reactions~     (ISRs). The study will allow the comparison of tolerability data with historical data for~     both Rebif New and classic formulations, and will do so by using the same pre- specified~     preferred terms of treatment emergent adverse events as done in historical studies. In~     addition, the study will analyse whether interaction(s) with a nurse impacts tolerability and~     the impact of Rebif New Formulation on the patient's Quality of Life.~   "
188154|NCT01101763|"~     This is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics~     of [13C3,4]-cholesterol (Part I) and to assess the test-retest reproducibility (Part II) of~     Reverse Cholesterol Transport (RCT) measurements. The study will determine whether atom~     percent enrichment (% APE) at 18 hours can be extrapolated from the steady-state value and~     whether the mean difference in repeat Ra measurements is below is a prespecified level.~   "
188155|NCT01101750|"~     The purpose of the study is to understand if children with liver and kidney transplants~     develop the antibodies from the Gardasil vaccine.~      The Gardasil vaccine protects against Human Papilloma Virus (HPV) types 16 and 18, which~     cause most types of cancers of the cervix, vagina and vulva. It also protects against Human~     Papilloma Virus types 6 and 11, which cause genital warts in some people. Gardasil has been~     approved by the Food and Drug Administration and is recommended for girls and women from ages~     9-26 for the prevention of some types of cancer of the cervix, vagina and vulva as well as~     preventing some types of genital warts. In males that are 9-26 years old, the FDA has~     approved its use for prevention of some types of genital warts.~      The Gardasil vaccine is made from a virus like particle and does not contain any live virus.~     Children with an allergy to yeast should not receive the vaccine since some components of the~     vaccine are made from yeast.~      People who have undergone organ transplant are at increased risk of of developing genital~     warts and cancers related to HPV when compared to the general population. The American~     Society of Transplantation and the American Society of Transplant Surgeons recommend the~     vaccine for people with transplants.~      Studies of other vaccines like Hepatitis B have shown children after transplant have less of~     a response to this vaccine and are not immune to the Hepatitis B virus. We are interested in~     seeing if your child will form antibodies (immune response) to the Gardasil vaccine.~      Your child is being asked to be in the study because he or she is between the ages of 9-17~     and has undergone a liver or kidney transplant more than 6 months ago and does not have any~     signs of organ rejection.~   "
188156|NCT01101737|"~     The investigators will do a trial in two general practices to see if the introduction of a~     blood pressure clinic staffed by a specialist nurse supported by visiting consultant improves~     blood pressure control compared to usual care.~   "
188157|NCT01101724|"~     The purpose of this study is to find out if strict rest for 5 days helps children get better~     after concussion.~   "
188158|NCT01101711|"~     Investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage~     (SAH), and to see if this has a relation to CNS lesions as evaluated by MRI and to common~     symptoms after SAH such as general exhaustion, lack of initiative, increased sleep demand and~     reduced quality of life.~   "
188159|NCT01101698|"~     Vessel calcification is a recognised cardiovascular morbidity risk factor in patients with~     chronic kidney disease (CKD). Recent reports indicate a significant role of Matrix~     Gla-protein (MGP) in decreasing calcification processes. MGP is excretion protein whose~     mechanism of action is not yet fully explained and which to be activated requires~     phosphorylation and carboxylation where cofactor is vitamin K. These observations indicate~     that shortage of vitamin K is a significant risk factor for the development of vessel~     calcification. Another calcification risk factor in CKD patients are calcium-phosphate~     disturbances and insufficiency of vitamin D3 which in physiological concentration stimulates~     MGP transcription. The aim of this study is estimation of influence of vitamin K2~     administration over the period of 9 months on vessel calcification in 3.- 5. stage CKD~     patients.~      It is a prospective, randomised double-blind study carried out in parallel groups. 60~     patients with CKD (GFR 15-60 ml/min) with calcium score >10 (Agatston scoring system) will be~     qualified for the study. On the basis of randomised selection, patients will be divided into~     two groups: 30 patients will be given 90 μg vitamin K2 + 10 μg and cholecalciferol 30~     patients will be given only 10 μg cholecalciferol. After a 9-month treatment the image~     diagnostic will be carried out in order to estimate the degree of vessel calcification.~   "
188160|NCT01101685|"~     This study aims to improve understanding of how people with low mood and negative feelings~     (known as dysphoric) may be different from people with normal mood and feelings~     (nondysphoric) when responding to a variety of social and emotional information. The study~     will look at the patterns of activity in peoples' brains in situations (presented as a~     battery of tests) after treatment with a medicine (escitalopram) or a placebo. The results~     from this study will help to gather information about the effectiveness of the various tests~     being used in this study in detecting any changes due to treatment with an antidepressant.~     Half the volunteers taking part in this study will be dysphoric (mildly depressed) whilst the~     other half of volunteers will be healthy volunteers. It is hoped that the results of this~     study will provide guidance for assessing effectiveness of new medicines and potentially help~     with the treatment of depression.~   "
188161|NCT01101672|"~     This study aims to compare the outcomes of patients who undergo single-port laparoscopic~     colectomy and conventional laparoscopic colectomy for colonic neoplasia (large polyp not~     amenable to endoscopic removal/ cancer) through a randomized controlled trial. After informed~     consent, patients will be randomized to have either conventional or single-port laparoscopic~     colectomy by a team of surgeons with good experience in laparoscopic colorectal surgery.~     Patients' demographic, operative detail and post-operative outcomes including operating time,~     blood loss, complications, pain score, analgesic requirement, resumption of gastrointestinal~     function and length of hospital stay will be recorded prospectively. The patients will be~     blinded to the type of treatment that they have received during the first three days after~     operation (post-operative pain and analgesic requirement will be recorded in these period).~     Patients will have long term up to record for cancer recurrence and survival.~      The results of two groups of patients will be compared scientifically to assess if~     single-incision laparoscopic colectomy results in any difference in outcomes when compared to~     conventional laparoscopic colectomy.~   "
188163|NCT01101646|"~     The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2~     different formulations, assess the effect of food on the pharmacokinetics and assess safety~     of rabeprazole sodium in healthy volunteers. Rabeprazole sodium is a drug used to treat~     patients with Gastro Esophageal Reflux Disease (GERD). GERD is a condition in which the~     esophagus (tube from throat to stomach) becomes irritated or inflamed because of acid backing~     up from the stomach.~   "
188164|NCT01101633|"~     The aim of the study is to investigate the effects of a low-calorie alginate containing fruit~     flavored beverage on appetite and body weight development.~   "
188165|NCT01101620|"~     The purpose of this study is to investigate if levosimendan improves contractile performance~     of the diaphragm in healthy subjects.~   "
188166|NCT01101607|"~     Distal forearm fractures are amongst the most frequently encountered orthopedic injuries in~     the pediatric emergency department (ED). Immediate closed manipulation and cast~     immobilization, is still the mainstay of management. The initial management of non-displaced~     or minimally displaced extremity fractures and relocation of uncomplicated joint dislocations~     is part of the usual practice of emergency medicine. Although focused training in~     fracture-dislocation reduction techniques is a part of the core curriculum of emergency~     medicine training programs, there is limited data discussing outcomes following restorative~     fracture care by pediatric emergency medicine (PEM)physicians.~      The primary objective of this study is to compare length-of-stay and clinical outcomes after~     closed manipulation of uncomplicated, isolated, distal forearm fractures, by PEMs to those~     after manipulation by pediatric orthopedic surgeons. Our hypothesis is that there is no~     difference in emergency department length-of-stay when fracture reduction is performed by a~     PEM versus a post graduate year 3 or 4 orthopedic resident. Secondary outcomes that will be~     assessed include: loss of reduction needing re-manipulation at follow up, cast related~     complications, radiographic and functional healing at 6-8 weeks post injury.~   "
188167|NCT01101594|"~     This study is a Ph I trial to test the safety of the study drug, hLL1-DOX at different dose~     levels in patients with recurrent multiple myeloma. HLL1 is also known as milatuzumab and is~     attached to doxorubicin in this clinical trial.~   "
188168|NCT01101581|"~     The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two~     antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to~     a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab~     attack different areas on lymphoma cells. Because of this, treatment with the combination may~     provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given~     alone.~   "
188169|NCT01101568|"~     This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the~     effect of repeated doses of GSK1292263 on the pharmacokinetics of rosuvastatin and~     simvastatin in healthy adult subjects. Each subject will receive single doses of simvastatin~     and rosuvastatin on two occasions, once alone and once following administration of repeated~     (BID) doses of GSK1292263.~   "
188170|NCT01101555|"~     This study is a randomised, single-blind, placebo-controlled, repeat dose study of~     otelixizumab administered subcutaneously in rheumatoid arthritis patients. One cohort will~     receive a single dose of adalimumab (HUMIRA, Abbott) as rescue medication to assess~     additional concomitant safety and tolerability issues.~   "
188171|NCT01101542|"~     This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK~     Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as~     per the regulations of the Korean Food and Drugs Administration (KFDA).~   "
188172|NCT01101529|"~     Delayed nausea is a common problem after high dose chemotherapy for bone marrow~     transplantation. This study wants to compare standard prophylactic anti-emetic therapy with~     the same treatment plus the drug aprepitant (Emend). The hypothesis is that addition of Emend~     will reduce nausea and vomiting.~   "
188173|NCT01101503|"~     The endothelial dysfunction is the early event in atherosclerosis. The investigator previous~     study showed that impaired endothelial function exist in newly diagnosed type 2 diabetes. The~     investigators hypothesize that intensive multifactorial therapy including intensive blood~     control and intensive hypertension control as well as intensive blood lipids control of 1~     year can improve vascular endothelial function. Moreover, the improvement of endothelial~     function maintains after 5 years or 10 years of intensive multifactorial therapy, called~     Metabolic Memorial Effect of improvement of endothelial function.~   "
188174|NCT01101490|"~     The purpose of this study is to determine changes of right and left cerebral oxygen~     saturation and blood flow during nephrectomy in lateral decubitus position.~   "
188175|NCT01101477|"~     Flexible bronchoscopy (FB) sedation requires keeping sedative level in a narrow window to~     prevent over or under sedation. Sedative drug titration according to subjective adjustment by~     individual physician may cause unsteady drug concentration. Target controlled infusion (TCI)~     has been provided a precise pharmacokinetic control of propofol, direct control the effect~     side, (eg. Brain) concentration (Ce), and been applied in surgical anesthesia and variable~     procedure sedation. We designed this pilot study to evaluate the optimal regimen of TCI in FB~     sedation.~   "
188176|NCT01101464|"~     A trial to compare if one 15 mg under the tongue tablet is equal to three 5 mg under the~     tongue tablets of Org 5222 (asenapine) in subjects with schizophrenia or schizoaffective~     disorder delivered.~   "
188177|NCT01101451|"~     This randomized phase III trial studies radiation therapy with chemotherapy to see how well~     it works compared to radiation therapy alone in treating patients with stage I or stage II~     cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays~     to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. It is not yet known whether giving radiation therapy together with chemotherapy is~     more effective than radiation therapy alone in treating patients with cervical cancer.~   "
188178|NCT01101438|"~     This study is looking at whether Metformin, an agent that is commonly used to treat diabetes,~     can decrease or affect the ability of breast cancer cells to grow and whether Metformin will~     work with other therapies to keep cancer from recurring. Health Canada has not approved the~     sale or use of Metformin to treat breast cancer, although they have approved its use in this~     clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its~     use in breast cancer is considered investigational.~   "
188179|NCT01101425|"~     Rationale: Gathering medical information and tumor samples from patients with male breast~     cancer may help doctors learn more about the disease.~      Purpose retrospective part: to perform a large international retrospective analysis of~     clinical and biological data of male BC patients treated in the participating centers from~     1990 to 2010.~      Purpose prospective part: to create a registry of men with breast cancer for a period of 30~     months (starting early 2014).~   "
188180|NCT01101412|"~     RATIONALE: Antimicrobial solution comprising trimethoprim-sulfamethoxazole, edetate calcium~     disodium, and ethanol may help prevent blockages and infections from forming in patients with~     central venous access catheters or peripheral venous catheters.~      PURPOSE: This randomized trial is studying an antimicrobial solution or saline solution in~     maintaining catheter patency and preventing catheter-related blood infections in patients~     with malignancies.~   "
188181|NCT01101399|"~     Anaemia and functional iron deficiency are common conditions in patients with lymphoid~     malignancies, conditions which reduce significantly the quality of life and increase~     morbidity and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been~     used, but recently their use has been shown to have a negative impact on overall survival in~     different oncology populations. Recently published data suggest that intravenous (IV) iron~     can be effective in anaemia treatment, even without ESAs. This exploratory study is the first~     clinical project with ferric carboxymaltose (FCM) in patients with lymphoid malignancies: the~     data generated may be used for further evaluations of the drug in larger populations. In this~     study, 1,000 mg of IV iron as FCM will be administered on the same day or within 24 hours~     before or after chemotherapy treatment. The primary objective is to evaluate the efficacy of~     FCM in the correction of haemoglobin levels in anaemic subjects with lymphoid malignancies,~     undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of~     FCM, and the effect of FCM treatment on iron status variables in subjects suffering from~     lymphoid malignancies.~   "
188182|NCT01101386|"~     This study's primary objective is to determine if continuous renal replacement therapy (CRRT)~     can adequately remove the sulfobutylether-ß-cyclodextrin sodium (SBECD) vehicle from the~     blood so that intravenous voriconazole can be utilized in critically ill patients with renal~     dysfunction requiring dialysis. Secondarily, the pharmacokinetics of intravenous voriconazole~     and its metabolite (UK121-265) and adverse effects of SBECD accumulation will also be~     evaluated. The study hypothesis is that CRRT is effective at removing SBECD and allows~     patients to receive intravenous voriconazole without the concern of SBECD accumulation.~   "
188183|NCT01101373|"~     This study will report on the outcome of a clinical program, operational since 1998, that has~     used surgery targeting an emotional pathway in the brain in the treatment of severe~     depressive illness that has failed to respond to all other available interventions. Benefit~     from surgery was anticipated on the basis that the lesion (bilateral anterior capsulotomy) is~     a well established surgical target for treating severe treatment resistant depression.~   "
188184|NCT01101360|"~     The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port~     Wine Stains based on clinical and histological analyses.~   "
188185|NCT01101347|"~     The purpose of this study is to evaluate safety and performance of the Surpass~     Aneurysm-Embolization System.~   "
188186|NCT01101334|"~     This is a Phase 2 and open-label (subject will know the treatment he or she is receiving)~     study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.~      The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of~     survival in subjects with advanced non-small cell lung cancer who failed the first treatment.~   "
188187|NCT01101321|"~     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80~     mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured~     at the Wilson, NC facility in the fasted state.~   "
188188|NCT01101308|"~     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10~     mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured~     at the Wilson, NC facility in the fasted state.~   "
188189|NCT01101295|"~     The primary purpose of the study is to describe by a prospective observational study the~     serious adverse events occurring in patients treated off-label by rituximab for Immune~     Thrombocytopenia.~   "
188190|NCT01101282|"~     This study aims to identify whether the addition of positive expiratory pressure (PEP) mask~     therapy to standard medical care improves clinically important outcomes in individuals with~     acute exacerbations of chronic obstructive pulmonary disease. It is hypothesized that those~     who receive the additional PEP mask therapy will show greater improvements than those who do~     not.~   "
188191|NCT01101269|"~     The purpose of the study is to investigate the effect of a blood pressure medication,~     Lisinopril, or similar drugs in that class, on the flow of blood to the kidneys. In this~     study, we will compare blood flow to the kidneys in healthy people that do not have diabetes~     or kidney disease with people that have diabetes and evidence of kidney disease.~   "
188192|NCT01101256|"~     The purpose of this study is to determine residual anticoagulatory effects of a prophylactic~     or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of~     therapy etc.~   "
188193|NCT01101243|"~     The purpose of the study is to determine the frequency of UVB radiations necessary to~     maintain the Vitamin D level during winter time.~   "
188194|NCT01101230|"~     The purpose of this research is to build the evidence base for approval of FDA health claims~     related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled~     feeding study was designed to compare the effects of two blood cholesterol lowering diets~     that meet the American Heart Association recommendations. The nutrient profiles of the~     control diet (no almonds/day) and almond diet (1.5 oz. of almonds/day) are matched for~     protein, saturated fat, and cholesterol. The study population consists of two cohorts of 25~     men and women with moderately elevated LDL-C. The investigators hypothesize that a~     cholesterol-lowering diet designed with almonds confers greater cardioprotective effects than~     a cholesterol-lowering diet without almonds on the basis of the LDL-C lowering response,~     effect on LDL particle size, abdominal adiposity and vascular health.~   "
188195|NCT01101217|"~     The purpose of this study is to study the effect of zinc supplementation in end stage renal~     failure on hemocystein level.~   "
188200|NCT01101152|"~     DVS is the main metabolite of the antidepressant/anxiolytic medication Venlafaxine (Effexor).~     Like parent compound, DVS is an antidepressant inhibiting both serotonin (5-HT) and~     norepinephrine (NE) reuptake. However, no studies to date describe the in vivo potency of~     this drug on monoamines reuptake. Consequently, it appears essential to determine the potency~     of DVS in human subjects using a wide dose range in order to determine at which dose(s) it~     starts inhibiting 5-HT and NE reuptake. The investigators are interested in learning whether~     there is a gender difference in the dose of the study medication at which NE reuptake~     inhibition occurs.~   "
188201|NCT01101139|"~     This study is designed to investigate, whether Sugammadex improves muscle function after~     standard neuromuscular recovery (TOF 0.9) from relaxation with rocuronium.~   "
188202|NCT01101126|"~     The purpose of this study is to determine whether disease management program is effective in~     preventing acute exacerbations in patients with unstable chronic obstructive pulmonary~     disease (COPD) or asthma.~   "
188203|NCT01101113|"~     This study is designed in order to investigate the effect of cinacalcet in combination with~     routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT)~     and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with~     unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent~     National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for~     dialysis patients.~   "
188204|NCT01101100|"~     This study is an open-label extension of study 20090062 to evaluate extended subcutaneous~     dosing of AMG 827 for up to 362 weeks.~   "
188205|NCT01101087|"~     Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to~     determine whether or not the use of Taurolock (a catheter lock solution) can prevent~     bacterial peritonitis in patients undergoing peritoneal dialysis.~   "
188206|NCT01101074|"~     This observational study will evaluate the safety and effectiveness following administration~     of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad~     hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.~   "
188207|NCT01101061|"~     The purpose of this study is to assess the safety, tolerability and potential immune response~     of AMG 785 following single subcutaneous (SC, injection under the skin) dose administration~     in healthy postmenopausal Japanese women.~   "
188208|NCT01101048|"~     The purpose of this study is to assess the safety, tolerability, and potential immune~     response of AMG 167 following multiple subcutaneous (SC, injection under the skin) dose~     administrations in healthy men and postmenopausal women with low bone mineral density.~   "
188209|NCT01101035|"~     The purpose of this study is to see whether subjects with gout who receive febuxostat or~     allopurinol for up to 9 years have a higher rate of serious heart and blood vessel~     complications (major cardiovascular events). Examples of major cardiovascular events include~     heart attacks, strokes, and angina (chest pain due to narrowing of the blood vessels of the~     heart) that need to be treated urgently with a heart operation. The overall duration of the~     study is dependent on the number of predefined major cardiovascular events (MACE). The length~     of study is expected to be approximately 9 years in order to observe the required 624 MACE.~     The length of study participation for each subject will vary due to the event driven study~     design.~      The purpose of this study is to see if subjects with gout who receive febuxostat or~     allopurinol, once daily (QD), have a higher rate of serious heart and blood vessel~     complications.~   "
188210|NCT01101022|"~     The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo~     on executive function (self-regulation) behaviors in adults with ADHD who report clinically~     significant impairment of executive function behavior in their everyday environment, as~     measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version~     (BRIEF-A) Global Executive Composite (GEC) T-score.~   "
188211|NCT01101009|"~     Comparison of the combination of amlodipine with an angiotensin receptor blocker or an~     angiotensin converting inhibitor, on central arterial blood pressure in patients with~     hypertension and additional risk factors. This is a randomised, double-blind, double-dummy,~     multicenter study. The duration of active treatment 24 weeks.~   "
188212|NCT01100996|"~     During sepsis and septic shock the immune response can be overwhelming leading to excessive~     tissue damage, organ failure and death. Ideally, the inflammatory response is modulated~     leading to both adequate protection to invading pathogens as well as limitation of an~     exuberant immune response. In the last years, experimental evidence has been accumulating~     that enteral administration of lipid-enriched nutrition attenuates inflammation and preserves~     organ integrity in several inflammatory models. The current study investigates the~     immune-modulating potential of enriched enteral nutrition in a human setting of experimental~     endotoxemia.~   "
188213|NCT01100970|"~     The purpose of this study is to determine whether there is a difference between cortisol~     levels in fetal blood of babies who were born while using a unipolar needle opposite to using~     a bipolar needle, and compared to the control group (infants who were born in a vaginal~     birth).~   "
188214|NCT01100957|"~     The study is in two parts~      Part one of the study describes the use of the new single-use flexible video-scope for~     intubation of patients with predicted normal airways.~      Part two compares the performance of the single-use flexible video-scope with that of a~     conventional flexible video-scope for awake intubation of patients with predicted difficult~     airways.~      The hypothesis is that the new single-use flexible video-scope for intubation performs as~     well as the traditional scope.~   "
188222|NCT01100853|"~     Until positive results were found with oral naltrexone, no medication has been effective~     against amphetamine dependence. The primary aim of this pilot study is to replicate the~     findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine~     addiction and to extend their results by randomizing treatment-seeking amphetamine addicted~     patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable~     suspension) or VIVITROL placebo. Patients in each group will receive drug counseling.~     VIVITROL is administered monthly and may be a better test of efficacy than tablets that must~     be taken daily.~   "
188223|NCT01100840|"~     The purpose of this study is:~        1. To characterize the types and frequency of molecular alterations to the epidermal growth~          factor receptor (EGFR) pathway, FGFR4 and EML-ALK in Asian patients with non-small cell~          lung cancer~        2. To identify candidate biomarkers of importance in the EGFR and estrogen pathways~      Most, if not all, human malignancies including lung cancer are caused by somatic alterations~     of the genome, leading to activation of oncogenes or inactivation of tumor suppressor genes~     and their resultant oncogenic effects. In addition to mutations, increased chromosomal copy~     number (by amplification or polysomy) and DNA methylation are other mechanisms of oncogene~     activation and tumour suppressor gene inactivation respectively.~      Little is known about the relationship between these oncogenes of the EGFR family and the~     recently described oncogenes FGFR4 and fusion gene EML4-ALK. Recent data suggests molecularly~     defined subgroups of non-small cell lung cancer (NSCLC) exist and can be used to predict for~     sensitivity to targeted agents (erlotinib or gefitinib) or cytotoxic chemotherapy~     (pemetrexate, gemcitabine, platinum agents). The findings that estrogen receptors are present~     in lung tumours and that estrogen can stimulate growth and proliferation of lung cancers in~     vitro and in vivo are provocative. Further studies to evaluate the role of estrogens and~     other sex hormones in lung cancer are warranted.~      A further understanding of the molecular indicators of lung cancer prognosis and treatment~     prediction would improve drug development and patient treatment selection.~      Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the~     Department of Pathology and the National University Tissue Repository respectively.~     Clinico-pathological characteristics will be obtained from the case records, Pathology and~     Tissue Repository. DNA will be isolated using standard techniques. Sequencing of genes in the~     EGFR signaling pathway: EGFR, KRAS, ErbB2, ErbB3, MET, PI3K, and BRAF as well as FGFR4.~     Unstained slides from the paraffin-embedded tissue will be obtained and subjected to~     fluoresce in vitro hybridization (FISH) for breakpoints in the EML4 and ALK genes as~     previously described. For cases that have been snap-frozen, RNA will be extracted and~     EML4-ALK fusions will be confirmed using RT-PCR and pre-specified primers. To analyse the~     expression of proteins of putative relevance to EGFR function (such as EGFR, ErbB2, ErbB3,~     AKT, MET, STAT, ERK, MAPK, cyclin D1, C/EBPa), downstream effects of EGFR: cell proliferation~     (Ki-67), angiogenesis (CD34, VEGF-A), apoptosis (bcl-2), metastasis, and hormonal influence~     (oestrogen and progesterone receptors, aromatase), TMA technology will be utilised. The~     status of the tumor suppressor genes PTEN and C/EBPa will be analysed.~   "
188224|NCT01100827|"~     To determine EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC.~      To determine the association between EGFR mutation status and demographic data in advanced~     stage adenocarcinoma NSCLC patients.~   "
188215|NCT01100944|"~     Background:~        -  Tumors of the thymus are rare and can be treated with surgery, but it is often difficult~          to determine whether a thymic tumor is malignant based on biopsy alone and the long-term~          survival rate is less than 50 percent. Because thymic tumors are so rare, most treatment~          knowledge comes from a relatively small series of cases, and the choice of treatment~          usually depends on the hospital or clinic staff's experience and familiarity with a~          given chemotherapy and surgery regimen.~        -  Belinostat is an investigational anticancer drug that has not yet been approved by the~          Food and Drug Administration for use in any cancer. Researchers are interested in~          determining whether belinostat can be combined with conventional chemotherapy to safely~          and effectively treat advanced thymic cancer.~      Objectives:~        -  To determine a safe and tolerable dose of belinostat that can be given in combination~          with cisplatin, doxorubicin, and cyclophosphamide.~        -  To determine if belinostat (combined with the abovementioned standard chemotherapy~          regimen) is effective against thymic cancer cells.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with advanced or recurrent~     thymic malignancy that is not considered to be curable with surgery or radiation therapy, and~     who have not received previous chemotherapy treatment.~      Design:~        -  Participants will be screened with a physical exam, blood tests, and imaging studies as~          directed by the study researchers.~        -  Participants will receive six 21-day cycles (18 weeks) of treatment with belinostat in~          combination with cisplatin, doxorubicin, and cyclophosphamide. The treatment will~          require continuous infusion over 3 days, and participants will remain in the treatment~          center during this time. Participants will have regular blood tests, clinic visits, and~          imaging studies during the treatment period.~        -  Participants who complete the six treatment cycles with no severe side effects may be~          offered the option to continue treatment with belinostat alone.~        -  After the 18-week study period, participants will return for regular follow-up exams for~          at least 4 weeks, and will be asked to remain in contact with the study researchers once~          a year to continue to study long-term effects....~   "
188216|NCT01100931|"~     Background:~        -  Carboplatin-paclitaxel is a commonly used chemotherapy combination for advanced~          non-small-cell lung carcinoma (NSCLC) and other solid tumors. In a randomized clinical~          trial, the combination of carboplatin, paclitaxel, and the additional chemotherapy drug~          bevacizumab had a better response rate and survival compared to carboplatin and~          paclitaxel alone. However, this trial treated only patients with a specific diagnosis~          and treatment risks. Further research is needed to determine whether this combination is~          useful for other diagnoses.~        -  YM155 is a drug that targets a type of chemical often found in cancer cells. It has been~          investigated in several phase I and phase II clinical trials, and it has been shown to~          be well tolerated and moderately effective in treating advanced NSCLC in patients who~          had not responded well to one or two standard treatments.~      Objectives:~      - To determine the efficacy of the combination of carboplatin, paclitaxel, and YM155 in the~     treatment of non-small-cell lung cancer.~      Eligibility:~      - Individuals 18 years of age and older who have been diagnosed with advanced non-small-cell~     lung carcinoma or other solid tumors for which standard therapy is not likely to be~     effective.~      Design:~        -  Before the start of the study, participants will be screened with a medical history,~          blood tests, imaging scans of the affected areas, tumor biopsies, and other tests as~          directed by the study doctors.~        -  Participants will be treated for six 21-day cycles, or 18 weeks of treatment. Each cycle~          will include blood tests and imaging studies as required.~        -  On day 1 of each cycle, participants will receive an infusion of paclitaxel and~          carboplatin, followed by a 4-day infusion of YM155 (through a portable electronic~          infusion pump).~        -  Participants will have a computed tomography scan or other imaging every other cycle~          (approximately every 6 weeks) to determine whether the therapy is affecting the cancer~          site.~        -  After the sixth cycle, participants will return for follow-up visits at least every 3~          months, and will be asked to remain in contact with the researchers to allow further~          study of the long-term effects of the treatment.~   "
188217|NCT01100918|"~     Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS~     duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of~     response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in~     prediction of response to CRT.~      The hypothesis is that the presence of mechanical dyssynchrony (measured using TDI~     echocardiography) successfully identifies heart failure patients who will respond to CRT.~     Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to~     CRT.~      This is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are~     implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no~     dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a)~     or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise~     test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months~     findings will be compared in all three groups.~   "
188218|NCT01100905|"~     Military personnel face intense physical and cognitive demands. Diminished iron status~     affects physiologic responses to these challenges. Both cross-sectional and longitudinal~     studies indicate a significant decrement in iron status in enlisted female military personnel~     immediately following basic combat training (BCT). Decrements in iron status are associated~     with diminished cognitive and physical performance, and may affect body composition. The~     primary objective of this randomized, placebo controlled study is to assess the utility of an~     iron-containing food product for maintaining iron status during BCT. This study will provide~     insight into the utility and efficacy of an iron-containing food product for the maintenance~     of iron status during military training. Furthermore, it will provide novel scientific data~     regarding the relationship between iron status and physical and cognitive performance in~     female Soldiers.~   "
188219|NCT01100892|"~     Cystic Fibrosis (CF) is the most common life-threatening genetic condition affecting~     Australian children. As well as repeated lung infections, children with CF develop insulin~     deficiency and eventually diabetes. The CF-IDEA trial (Cystic Fibrosis - Insulin Deficiency,~     Early Action) will determine whether starting insulin treatment before the onset of diabetes~     (earlier than current practice) will improve the health of children with CF by improving body~     weight and lung function.~   "
188220|NCT01100879|"~     Anaemia and functional iron deficiency are common conditions in Multiple Myeloma (MM)~     patients, conditions which reduce significantly the quality of life and increase morbidity~     and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been used, but~     recently their use has been shown to have a negative impact on overall survival in different~     oncology populations. Recently published data suggest that intravenous (IV) iron can be~     effective in anaemia treatment, even without ESAs. This exploratory study is the first~     clinical project with ferric carboxymaltose (FCM) in patients with MM: the data generated may~     be used for further evaluations of the drug in larger populations. In this study, 1,000 mg of~     IV iron as FCM will be administered on the same day or within 24 hours before or after~     chemotherapy treatment. The primary objective is to evaluate the efficacy of FCM given~     without ESA, in the correction of haemoglobin levels in subjects with MM, undergoing~     chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and~     the effect of FCM treatment on iron status variables in MM subjects.~   "
188221|NCT01100866|"~     This is a randomized, two-arm, placebo controlled trial to evaluate benefit of treatment~     using POMELLA™ extract on mechanisms known to drive prostate cancer. This research allows~     provision for biochemical and histological comparisons to be made between POMELLA™ treated~     and placebo treated prostate tissues removed from men with organ confined prostate cancer.~   "
188225|NCT01100814|"~     The investigators hypothesize that aberrant hypermethylation of tumour suppressor genes is an~     important mechanism for Epstein-Barr Virus (EBV) - related gastric carcinogenesis, the~     promoter hypermethylation status and the expression of S100A2 and TFF1 might be different~     between EBV-associated gastric cancer (GC) and non EBV-associated GC.~   "
188226|NCT01100801|"~     This is an open, non-randomized, multicenter Phase II study evaluating cisplatin plus TS-1 or~     oxaliplatin plus TS-1 as first-line therapy in predicted 'responder' to platinum and~     fluoropyrimidine.~      This study is planned in 3 centers in Singapore and Korea. A total of 30 subjects will be~     enrolled into each treatment arms. Each centers will recruit 15-25 subjects predicted to be~     'responder' to platinum and fluoropyrimidine. The study will consist of a prescreening~     period, a screening period and a treatment period. A fresh tumour biopsy sample will be~     obtained during the prescreening period for gene expression profiling.~      As this is a genomics guided trial, obtaining tissue biopsies is vital to the conduct of the~     trial.~      Patients will have the primary in situ (requirement for entry into trial), endoscopic biopsy~     performed prior to 1st cycle.~   "
188227|NCT01100788|"~     Populations that report high fiber consumption demonstrate lower rates of obesity. Enhanced~     satiety may play a key role in this relationship. The colonic fermentation of fibers is~     theorized to influence satiety and food intake. Short chain fructooligosaccharide (scFOS) are~     rapidly fermentable fibers that can easily be added to foods to impact these parameters.~      The objective of this study was to evaluate the satiety response of scFOS and its ability to~     decrease food intake.~   "
188228|NCT01100775|"~     Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early~     twenties, with cognitive impairments and negative symptoms frequently emerging much earlier.~     Such cognitive impairments and negative symptoms but much milder are also observed in~     high-risk groups (such as relatives of schizophrenia patients), who may or may not develop~     the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test~     the effects of galantamine on clinical/physiological/cognitive measures. This study serves~     several goals: If a drug is found effective in treating subtle deficits, then it will provide~     treatment strategy in individuals with schizophrenia spectrum personality disorders and for~     early intervention in schizophrenia. In addition, one of the difficulties of testing a drug~     on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can~     change the effects of the test drug. The proposed study will be in subjects who will not be~     taking antipsychotic medications. Our study will be carried out in two sessions, at least one~     month apart. Subjects will be randomly assigned to the two possible order of administration:~     the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3~     days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th~     day, the day of testing. We will administer a battery of~     clinical/cognitive/neurophysiological tests after the 8 mg drug dose.~   "
188229|NCT01100762|"~     The use of low level electrical stimulation when applied over the head, also called~     transcranial direct current stimulation (tDCS), is being tested by several groups of~     researchers to see if tDCS can improve movements of persons with damage to the brain. The~     safety and potential benefits of tDCS to children or adults patients who are paralyzed~     because of brain damage are reported in the medical literature. In addition, some patients~     with Parkinson's disease (PD) experience improvement in memory and report better use of the~     hand after tDCS. The treatment requires putting electrodes (pads) over the head and sending~     very small amount of electrical current that the patient may feel as little tingling.~     Application of tDCS takes 20 min. In this study we wish to test if tDCS application can~     improve stepping and walking ability of subjects with PD and if the improvement is the same~     as when walking on treadmill. We plan to test the subject's ability to step when pulled by a~     laboratory testing system and also test his/her walking ability. There will be 3 sessions 7~     days apart. In the first session the subject will be tested then treated for 20 min with tDCS~     and then tested again. In the second session the subject will be tested then walk on a~     treadmill for 20 min then tested again. In the third session the subject will be tested then~     walk on the treadmill for 20 min while receiving also tDCS and tested one last time at the~     end of the session. Each session will take between 2 and 3 hours.~   "
188230|NCT01100749|"~     Hepatitis C is a small RNA virus spread by blood to blood contamination. There are to date 6~     known genotypes and within each there are several subtypes. Although all genotypes are~     distributed worldwide some are more common in certain countries and/or among certain~     populations.~   "
188231|NCT01100736|"~     Endothelin-1 (ET-1) has been linked to a number of conditions including pulmonary arterial~     hypertension (PAH). ET-1 acts via 2 receptors, ETA and ETB. The ET-1 receptor blockers~     bosentan and sitaxsentan have been shown to be beneficial in patients with PAH. Bosentan~     blocks both ETA and ETB receptors. Sitaxsentan selectively blocks ETA receptors.~     Theoretically, selective ETA blockade may be associated with greater vasodilation and~     clearance of ET-1 by leaving the ETB receptor unblocked. This has not been directly studied~     in humans.~      We aim to investigate the endothelial ETB-mediated vascular responses between bosentan and~     sitaxsentan by using a ETB selective agonist (ET-3). We hypothesise that at clinically~     relevant doses:~        -  Bosentan will show evidence of ETB receptor blockade compared to sitaxsentan and~          placebo.~        -  These effects will be confirmed by 2 functional markers of ETB receptor antagonism:~          plasma ET-1 (a very sensitive, but not necessarily clinically relevant marker), and the~          forearm vasodilator response to ET-3.~   "
188232|NCT01100723|"~     This trial is designed to determine if the use of a computer algorithm designed to optimize~     mineral outcomes in dialysis patients increases the number of patients achieving the desired~     target endpoints for calcium, phosphorus and parathyroid hormone.~   "
188233|NCT01100710|"~     The purpose of this study is to determine the influence of functional or anatomic cardiac~     parameters, age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals.~   "
188245|NCT01100554|"~     The purpose of this study is to evaluate the upper airway collapsibility by sleep endoscopy~     in different sedative levels. Propofol pump infusion will be used to achieve conscious~     sedation. Bispectral Index monitor will be applied to the monitor the conscious level. Two~     different sedative levels (BIS 65-75, 50-60) will be achieved for upper airway evaluation.~     The severities of upper airway obstruction will be evaluated the correlation to the disease~     severities. Mandible advancement will be done to evaluate the response for oral appliance.~   "
188384|NCT01098721|"~     Psoriasis is a chronic inflammatory skin disorder that is characterized by hyperproliferation~     of the keratinocytes and inflammation of the epidermal and dermal layers of the skin. This~     study, in patients with mild to moderate plaque psoriasis, is designed to further determine~     the efficacy, safety and tolerability of the novel, topically applied, non-steroid,~     anti-inflammatory WBI-1001 cream over a period of 12 weeks.~   "
188234|NCT01100697|"~     Neural tube defects are one of the most prevalent congenital abnormalities, surpassed only by~     cardiac malformations. Spina bifida accounts for the majority of the neural tube defects and~     is comprised of a wide spectrum of anomalies ranging from small isolated sacral dysraphisms~     to large spinal defects. The origin of spina bifida is a failure of neurulation. It usually~     occurs at 15 days post-conception, resulting in a bony spinal defect with extrusion of the~     neural placode and/or the meninges outside of the spinal canal. Spina bifida has a prevalence~     of 1-5 in 1,000 live births and is the most complex congenital abnormality compatible to~     long-time survival. Concerning psychomotor development as well as urinary bladder and~     intestinal morbidity the prognosis ranges from normal functional outcome to severe~     disability.~      The diagnosis of serious fetal abnormalities such as spinal dysraphism by ultrasound~     screening allows patients to prepare for the birth of an impaired child or to consider~     termination of the pregnancy. In current practice, prenatal counseling and obstetric~     management depend not only on the detection of a spinal dysraphism but also on an appropriate~     assessment of the severity of the defect and its possible impact on the postnatal development~     of the affected child.~      Level and type of lesion, presence of associated anomalies (e.g., Chiari II malformation and~     ventriculomegaly) and mode of surgical closure are factors known to have prognostic impact on~     the postnatal outcome. Previous studies reported that postnatally determined lesion levels~     correlated well with functional status and survival. On the contrary, it is still not clear~     whether similar data obtained antenatally are of value.~      In this study, the investigators will review their database of all cases of prenatally~     diagnosed spina bifida within a 16 year period between 1993 and 2009. By analyzing the~     prenatal and postnatal characteristics of fetuses with spina bifida in relation to the~     anatomic level of the lesion, the investigators aim to contribute further information~     regarding the natural course of affected pregnancies and the correlation of prenatal~     ultrasound findings with their functional outcome.~   "
188235|NCT01100684|"~     The purpose of this study is to determine whether asimadoline is safe and effective at~     treating D-IBS.~   "
188236|NCT01100671|"~     Vascular inflammation is a key factor in both the pathogenesis and outcome of~     atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a~     promising tool for identifying and quantifying vascular inflammation within atherosclerotic~     plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium~     (CAC), the degree of stenosis, and the characteristics of plaque including its potential~     vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness~     of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.~   "
188237|NCT01100658|"~     While neurocognitive impairments in attention, memory and executive functioning are commonly~     reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to~     examine the treatment of attention deficits in this population. Numerous studies have~     examined the effectiveness of methylphenidate in the treatment of children with attention~     deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for~     improving attention and behavioral functioning in children with medical illnesses or brain~     injury are less clear.~      Patients will be randomized to receive one week of Metadate CD (a controlled release form of~     methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.~   "
188238|NCT01100645|"~     The main objective of this study is to evaluate the clinical efficacy of the drug Sominex~     (Valeriana officinalis L., 40 mg, 30 mg Crataegus oxyacantha L. and Passiflora incarnata L.~     50 mg) manufactured by the Laboratory EMS S / A, compared to placebo in improving sleep~     efficiency, based on the response of the sleep quality questionnaire (MSQ) and~     polysomnographic parameters described below:~        -  Latency to onset of sleep;~        -  Total time of sleep;~        -  Rapid eye movement (REM) sleep latency;~        -  Duration of REM sleep~   "
188239|NCT01100632|"~     We hope that with the drug, patients obtain reduced levels of stress and fatigue, according~     to the scales that we use in the study. Hopefully the results of the treated group are~     significantly higher than the control group (placebo).~   "
188240|NCT01100619|"~     The primary objective of this clinical study is to determine whether the inhibition of~     cytochrome P450 (CYP) isozyme CYP2C8 by XL184 observed in in vitro preclinical studies~     translates into the potential for clinically significant drug-drug interactions in humans.~     The study will measure the effect of once daily dosing of XL184 on the pharmacokinetics (PK)~     of rosiglitazone. The PK of XL184 when combined with rosiglitazone will be evaluated as well.~      A specific objective of this study is to determine whether the interaction between XL184 and~     a drug such as rosiglitazone is sufficiently large enough to necessitate a dosage adjustment~     when used in combination with XL184, or whether the interaction would require additional~     therapeutic monitoring.~      Rosiglitazone, commonly known as Avandia, is a prescription medicine approved by the FDA used~     to treat adults with Type 2 (adult-onset or non-insulin dependent) diabetes mellitus (high~     blood sugar). In this study, subjects will only take 2 doses of rosiglitazone. There is no~     intention of therapy as a result of taking rosiglitazone in this study.~   "
188241|NCT01100606|"~     A study to determine the safety, effectiveness, and acceptability of 2 methods of~     administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000~     lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic~     insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma~     (formerly Eurand).~   "
188242|NCT01100593|"~     The purpose of this study is to compare catheter length and extravasation rates for~     Ultrasound (US)-guided peripheral intravenous (IV) catheter insertion in a subset of~     emergency department patients with difficult IV access. Physicians, Emergency RNs, and~     Emergency Technicians can be taught to use US guidance to start peripheral IV in the ED. The~     optimal length of catheter to use for this procedure is unknown. This study will provide data~     on the length of catheter required to minimize extravasation. There is no guideline on~     catheter length selection for US-guided peripheral vascular access. This study may decrease~     extravasation rates for US-guided peripheral vascular access by providing guidance on~     catheter length selection.~   "
188243|NCT01100580|"~     Nephrolithiasis is a disease that strikes roughly 10% of the Italian population and its~     incidence in industrialized countries is on the increase. The most common form of the disease~     (80%) is Idiopathic Calcium Nephrolithiasis (ICN) with calcium-oxalate (CaOx) and/or~     calcium-phosphate (CaP) stones. The etiopathogenesis involves both genetic and acquired~     factors, the interplay of which leads to urinary biochemical anomalies at the root of stone~     formation. The elements and urinary compounds involved are known as urinary stone risk~     factors. The risk factors for CaOx stones consist of low urine volume, hypercalciuria,~     hyperoxaluria, hyperuricosuria, hypocitraturia and hypomagnesuria. In the case of CaP stones,~     the hyperphosphaturia and pH parameters are of particular importance; a pH>7 promotes the~     formation of stones prevalently composed of phosphates, while a pH of between 6 and 7,~     associated with a volume <1l/day, can raise CaP supersaturation to a dangerously high level~     and lead to the formation of mixed CaOx and CaP stones. For uric acid stones, the elements~     involved are hyperuricosuria and pH<5.5. In general, the most prevalent alteration in ICN is~     hypercalciuria (50%). Hypertension and obesity are also social diseases with important~     epidemiological similarities to nephrolithiasis. These affinities have led to the search for~     a common pathogenic moment. As far as hypertension is concerned, various studies have~     demonstrated high calciuria in hypertensives with a linear relationship between 24-h~     calciuria and arterial blood pressure. The incidence of stone disease is greater in~     hypertensives than in normotensives and, by the same token, the incidence of hypertension is~     greater in stone formers than in non stone formers, but it is not clear whether~     nephrolithiasis is a risk factor for hypertension or vice versa. Moreover, a linear~     relationship exists between calciuria and natriuria, where the calcium is the dependent~     variable, with a much steeper slope of the straight line in stone formers and hypertensives~     compared to controls. It has, in fact, been demonstrated that to reduce calcium, it is more~     efficacious to reduce sodium intake as opposed to calcium intake. Finally, BMI and body~     weight are independently associated with an increase in stone risk even though, due to a~     number of bias (limited weight categories, low number of obese persons in the study~     populations, no control group, no recording of food intake) the studies published failed to~     be conclusive. In the final analysis, stone disease, arterial hypertension and excess~     weight/obesity prove to be closely interconnected and it is possible to intervene with~     targeted diets aimed at reducing the risk of illness and death from these diseases. Among~     such dietary approaches, the reduction of sodium chloride in food, increased hydration and an~     increased intake of foods with an alkaline potential seem to play an important role.~      For many years now, the investigators research unit has been involved in projects, partially~     financed by the Italian Ministry of University and Research (MIUR), geared towards studying~     the effects induced by dietary changes in patients with calcium stone disease. The aim of the~     present project is to analyse in depth the relationship between stone disease, hypertension,~     body weight and water and salt intake both in the general population of the area of Parma~     (where historically and by gastronomic tradition, the usual diet tends to have a high salt~     content) and in a selected population of stone formers and hypertensives not under treatment.~     A representative sample of the population of the area of Parma will be studied, divided on~     the basis of weight category, in order to assess water and salt intake and relationships with~     the presence of hypertension, and a sample of normal and hypertensive stone formers~     randomized to receive for one year either water therapy+low salt diet or water therapy alone.~   "
188244|NCT01100567|"~     This study will evaluate the effects of a novel, non-pharmacologic intervention for the~     prevention of deleterious changes in bone density and strength in adolescents with anorexia~     nervosa (AN), a disease commonly treated with extended periods of bed rest and~     immobilization. The primary focus of the trial is to conduct a prospective short-term~     intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and~     to determine the long-term effects of a biomechanical intervention on skeletal health in~     ambulatory adolescents with AN.~   "
188246|NCT01100541|"~     The objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort,~     appearance, weight, superficial temperature, and other characteristics of a polymeric plate~     derived from castor oil developed to thermotherapy.~      The volunteers will use polymeric plate as a therapeutic resource in the shoulder area and~     then fill in, without interference of the researcher, some questions about the~     characteristics of interest.~   "
188247|NCT01100528|"~     RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving~     interferon alfa-2b together with dacarbazine may be an effective treatment for primary uveal~     melanoma.~      PURPOSE: This phase II trial is studying how well giving dacarbazine together with~     recombinant interferon alfa-2b works in treating patients with primary uveal melanoma with~     genetic imbalance.~   "
188248|NCT01100515|"~     Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While~     oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric~     oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO~     at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of~     normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and~     without coma.~   "
188249|NCT01100502|"~     This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate~     the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC)~     compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following~     autologous stem cell transplant (ASCT).~   "
188250|NCT01100489|"~     RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and~     may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays~     to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that~     remain after surgery.~      PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed~     by radiation therapy works in treating patients with stage I or stage II breast cancer.~   "
188251|NCT01100476|"~     The Mynx Vascular Closure Device (Mynx M5) is a sponge-like material used to close the hole~     in the artery after patients undergo a diagnostic endovascular procedures~   "
188252|NCT01100463|"~     The purpose of this research study is to see if combining uracil ointment (1UO) with~     capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects~     1UO and capecitabine may have in patients with metastatic breast cancer.~   "
188253|NCT01100450|"~     To test the strength and physical performance outcomes of a 12-week progressive resistance~     training (PRT) exercise program in a small cohort of patients with Class III obesity who are~     preparing for bariatric weight loss surgery at Beth Israel Deaconess. The study will also~     test patient compliance to the 12 week PRT program. Whereas PRT exercise is currently~     recommended as a part of preoperative clinical care for bariatric surgery patients, little~     research has been done to measure the acceptance and effectiveness of a standardized PRT~     exercise protocol for improving health and perioperative care. Preliminary data from this~     study could be used to justify larger studies and further investigation.~   "
188254|NCT01100437|"~     This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal~     signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are~     stabilized on EMBEDA.~   "
188255|NCT01100424|"~     The purpose of this study was to investigate the association of inflammatory mediators found~     in the tear film during the development and following the induction of contact lens~     solution-induced corneal staining.~   "
188256|NCT01100411|"~     The purpose of this study is to evaluate changes in contact lens geometry after lens wear~   "
188257|NCT01100398|"~     Prospective determination of the prevalence of non-alcoholic fatty liver disease (NAFLD) and~     non-alcoholic steatohepatitis (NASH)in a primary care setting using ultrasound and~     percutaneous liver biopsy.~   "
188258|NCT01100385|"~     Does tomato extract improve blood vessel function in healthy people and people with~     cardiovascular disease?~      Atherosclerosis ('furring' of the arteries) affects the functioning of blood vessels,~     narrowing and eventually blocking them, causing conditions like heart attack and stroke. The~     Mediterranean diet, which is rich in tomatoes and tomato-based products, has been shown to be~     associated with a reduced risk of blood vessel damage. In this double blind,~     placebo-controlled randomised study, the investigators will investigate whether a food~     supplement containing a standardised extract of tomato improves blood vessel function in both~     healthy people (aged 40-80), and people with a history of cardiovascular disease. The food~     supplement is on sale to the public, and the investigators are testing the standard dose.~     Approximately 72 people will take part at the Clinical Pharmacology Unit at the ACCI~     Building, Cambridge University Hospitals NHS Trust.~      After they have passed screening tests, participants will be allocated by chance to receive~     either the tomato extract product (Ateronon), or a matching placebo (a dummy capsule with no~     active ingredients), which they will take once a day for 8 weeks. At the beginning and end of~     the treatment period, the investigators will test blood vessel stiffness using an ECG machine~     and external probe. The investigators will also measure forearm blood flow, which involves~     infusing 3 separate agents that affect how the lining of the blood vessel wall works, and~     helps to assess whether this is affected by the study treatment. Blood tests will also be~     used to look at how the food supplement is working and its effects on cholesterol and markers~     of inflammation. Including the screening period, and a follow-up telephone call two weeks~     after the end of treatment, participants will be in the study for 14 weeks.~   "
188259|NCT01100372|"~     RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and~     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. It is not yet known whether~     liposome-encapsulated doxorubicin citrate is more effective when given together with or~     without gemcitabine hydrochloride in killing tumor cells.~      PURPOSE: This randomized phase II trial is studying liposome-encapsulated doxorubicin citrate~     given together with gemcitabine hydrochloride to see how well it works compared with~     liposome-encapsulated doxorubicin citrate alone in treating patients with ovarian epithelial~     cancer, fallopian tube cancer, or primary peritoneal cavity cancer.~   "
188260|NCT01100359|"~     RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well liposome-encapsulated doxorubicin citrate~     given together with carboplatin works in treating patients with advanced or metastatic~     recurrent endometrial cancer.~   "
188277|NCT01100112|"~     Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg~     Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are~     not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01~     (parent study [NCT00679432]).~   "
188556|NCT01096420|"~     The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment~     compared with pharmacologic treatment in patients with chronic migraines.Besides, the~     investigators tested whether the clinical effects of acupuncture in chronic migraine~     prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).~   "
188261|NCT01100346|"~     This is a single center, prospective, observational study on the use of Gonal-f in controlled~     ovarian hyperstimulation (COH) in subjects undergoing ovulation induction/ intrauterine~     insemination (OI/IUI) therapy across Taiwan. It has been observed in the previous studies~     that COH with follicle stimulating hormone (FSH) is considered as one of the positive~     predictors of an ongoing pregnancy. Many studies in the past have tried to predict the FSH~     threshold, defined as the FSH dose on the day when a follicle is >10 mm in diameter, but no~     studies have been conducted to date to determine the predictive factors for a monofollicular~     development after COH in IUI cycles. Monofollicular growth contributes significantly to the~     reduction of multiple pregnancies and thus minimize the risks associated with such~     pregnancies. This study would provide preliminary data on the factors associated with a~     monofollicular development in Gonal-f treated cycles using a low dose step-up regimen.~   "
188262|NCT01100333|"~     This non-interventional study (NIS) is planned to examine the consistency of the dose~     recommended by the doctor for the first stimulation day with the dose recommended by the~     CONSORT calculator.~   "
188263|NCT01100320|"~     To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original~     OxyContin® (OXY) formulation (40 mg) in the fed state.~   "
188264|NCT01100307|"~     The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham~     injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular~     edema.~   "
188265|NCT01100294|"~     To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in~     children.~   "
188266|NCT01100281|"~     The capacity of concept formation is not well understood, even if a link is supposed with the~     functioning of the frontal lobes.~      Our aim is to better understand the cognitive mechanisms underlying this function and to try~     to correlate the performance with atrophy of the frontal lobe in neurodegenerative diseases~     involving this region (frontotemporal lobar degeneration and progressive supranuclear palsy).~   "
188267|NCT01100268|"~     Available data suggest that compulsive hoarders have cognitive deficits, particularly with~     sustaining attention that might contribute their hoarding symptoms.~   "
188268|NCT01100255|"~     In this study investigators are studying the effects of a drug called ketamine on the~     symptoms of Obsessive-compulsive disorder (OCD).~   "
188269|NCT01100242|"~     This is an open label, non-randomized, single arm phase II study. The primary objective of~     this study is to investigate the efficacy of combination of sorafenib and VELCADE®~     (bortezomib). The primary efficacy endpoint is Progression-Free Survival (PFS). The secondary~     objectives of this study are to:~      Assess the response rate of this combination in this patient population and Assess the~     toxicity of this combination in this patient population~   "
188270|NCT01100216|"~     With the advent of restrictions on public smoking, the tobacco industry has introduced a~     variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These~     products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than~     conventional smokeless products out on the market. No studies have compared the effects of~     NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the~     NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is~     that the effects from these products will be directly related to their nicotine content and~     sensory effects. Products that produce greater effects on outcome measures may serve as~     potential cessation tools.~   "
188271|NCT01100203|"~     Patients with Chronic Kidney Disease (CKD) have a poor prognosis primarily due to~     cardiovascular disease. The cardiovascular risk can be assessed by measurements of arterial~     stiffness. A decrease in stiffness has been shown to decrease the risk of cardiovascular~     disease as well as death. Most of the CKD population also have hypertension and the control~     of blood pressure is one of the corner stones in inhibition of disease progression. Using~     drugs that specifically block the renin-angiotensin-system for blood pressure control has~     been shown to have a beneficial impact on inhibition of progression beyond that of the~     achieved blood pressure control. It has been reported that inhibition of the hormone~     aldosterone has a positive effect on survival in patients with heart failure, hypertension~     and diabetic as well as on-diabetic nephropathy.~      This study undertakes the investigation of the influence on arterial stiffness of adding an~     aldosterone receptor inhibitor to the medication CKD patients are already taking. Besides the~     primary end point which is Pulse wave velocity (PWV), arterial stiffness is also quantified~     thorough ambulatory blood pressure measurements.~   "
188272|NCT01100190|"~     The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial~     Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.~   "
188273|NCT01100177|"~     Sunitinib seems to be a promising treatment for the objective of this proposal: to evaluate~     the clinical activity of Sunitinib as first line therapy in patients who have measurable~     disease and to evaluate the safety of Sunitinib with radiation therapy.~   "
188274|NCT01100164|"~     The primary objective of the study is to determine whether eszopiclone (Eurofarma) is~     non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of~     insomnia.~   "
188275|NCT01100151|"~     The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in~     adults with opioid-induced constipation (OIC) following repeat dose administration~   "
188276|NCT01100125|"~     It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose~     levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV~     inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon~     secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that~     combination therapy with DPP-IV inhibitors and other oral antidiabetic medication have~     additive or synergistic effects in lowering glycose level, preserving beta-cell mass and~     function as well as enhancing insulin sensitivity. However, there have been few studies about~     the glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin~     treatment.~      The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may~     have favorable effects on glucose control and endogenous insulin secretory function in type 2~     diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor)~     add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin~     treatment.~   "
188278|NCT01100099|"~     The investigators will evaluate the use of an HLA-DQ2-gliadin tetramer for staining of gluten~     specific T cells in the diagnostics of uncertain celiac disease. Some patients have started~     on a gluten free diet without a diagnosis of celiac disease. Subsequent later investigation~     in special care is difficult as the patients often are reluctant to prolonged gluten~     challenge. The investigators use the HLA-DQ2-gliadin tetramers for detection of gluten~     specific T cells after a short gluten challenge. By this method the investigators search to~     discriminate between true celiac disease and clinical gluten intolerance without celiac~     disease, in a population of HLA-DQ2+ persons already on a gluten free diet without a formal~     diagnosis of celiac disease.~   "
188279|NCT01100086|"~     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10~     mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fasted state.~   "
188280|NCT01100073|"~     The study will compare the effect of pramipexole on different types of tremor and~     particularly kinetic tremor in early and advanced Parkinson's disease patients and will~     evaluate the course of tremor measured with spiralometry under pramipexole treatment.~   "
188281|NCT01100060|"~     Estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg)~     and the chloroquine (620 mg CQ base) test formulation compared to co-administered immediate~     release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg CQ base) in~     healthy adult subjects.~   "
188282|NCT01100047|"~     This is a study in Japanese healthy volunteers to determine the safety and tolerability of~     the compound, AZD5069. It will also assess how the body handles the drug and how it responds~     to the drug following single and multiple doses up to 11 days.~   "
188283|NCT01100034|"~     Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of~     the world's population. The epidemiology of pediatric psoriasis has not been well documented~     and no treatment guidelines exist for pediatric psoriasis.~      Etanercept is a biologic drug and has been licensed for the treatment of chronic severe~     plaque psoriasis in children and adolescents (8-17 years of age) who are inadequately~     controlled by or are intolerant to, other systemic therapies or phototherapies. Although the~     long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis~     (JIA) has been studied and the short-term safety profile of etanercept in both JIA and~     pediatric psoriasis appears similar, there is limited data available about the long-term~     effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim~     of this study is to assess the safety and effectiveness of etanercept for the treatment of~     pediatric psoriasis in Europe. Patients aged 4-17 with plaque psoriasis diagnosed by a~     dermatologist will be invited to participate in the registry only after a clinical decision~     has been made to prescribe etanercept. The safety of the drug and how well the drug works~     will be evaluated during the follow-up period. The follow-up period will last 5 years and~     patients will be followed up every 3 months for the first 2 years and every 6 months for the~     next 3 years.~   "
188284|NCT01100021|"~     The purpose of this study is to see if avanafil causes any changes in blood pressure and~     pulse rate when taken with doxazosin or tamsulosin.~   "
188285|NCT01100008|"~     Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment~     depends on the severity of the disease.~      This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and~     identification of parameters useful for the follow-up in order to adapt the medical treatment~     to status of the patient.~      Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.~   "
188286|NCT01099995|"~     Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While~     oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric~     oxygen therapy (HBO) remain controversial. This study aimed at comparing two sessions of HBO~     at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours~     of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide~     poisoning.~   "
188287|NCT01099982|"~     Hypothesis:~      Tissue and serum samples collected from end-stage heart failure patients receiving left~     ventricular assist device implantation (LVAD) or heart transplantation will provide~     information regarding the basic science of heart disease. Tissue and serum samples collected~     from a limited numbers of healthy controls (donor grafts that were not utilized for heart~     transplantation) will serve as a comparator in research database projects.~      Design:~      This is a registry project; there are no investigational treatments, drug or procedures~     associated with participation in registry activities. This project is an organized functional~     data and tissue data gathering and storing (database) endeavor with specific focus on the~     functional, structural, and molecular aspects of heart failure. Data collection will not~     immediately influence the course of treatment for any patient.~   "
188288|NCT01099969|"~     The purpose of this study is to compare the safety and efficacy of Endotrol Tube compared to~     the conventional endotracheal tube in conjunction with the GlideRite stylet (Verathon Medical~     Inc, USA) during videolaryngoscopy assisted endotracheal intubation using a McGrath (Aircraft~     Medical Ltd., and distributed in the US by LMA North America, Inc.) video laryngoscope or a~     GlideScope (Verathon Medical Inc, USA). The investigators hypothesize that using the Endotrol~     tracheal tube, (Covidien, Colorado, USA) is safer and more efficacious than using the~     conventional endotracheal tube during McGrath video laryngoscope and/or GlideScope aided~     endotracheal intubation.~   "
188289|NCT01099956|"~     The study propose to measure the inflammation level in type 1 diabetes children with the~     cytokine analysis compared to non diabetic children of the same sibling and to healthy~     children.~   "
188313|NCT01099644|"~     The purpose of this study is to test the safety of a new medicine called antibody 8H9~     injected into the lining of the abdomen or peritoneum, where the tumor is. This medicine is~     an antibody or protein which binds to certain tumors, including DSCRT. There is a small~     number of DSCRT which do not bind with 8H9. If the tumor does not bind with 8H9, you might~     not benefit from this treatment. The investigators want to find out what effects, good and/or~     bad, it has.~      This antibody is made in mice. Radioactive iodine can be bound to this antibody to deliver~     radiation to the tumor. The investigators wish to determine the safety of radiolabeled 8H9 at~     different dose levels. This is the first study using 131I-8H9 in the peritoneum.~   "
188290|NCT01099943|"~     Hypotheses and Specific Aims:~      The continued emergence of antibiotic-resistance in the outpatient setting underlines the~     need to responsibly manage antimicrobial prescribing. It is in this context that we seek to~     test an effective strategy for reducing the inappropriate use of antibiotics in primary care~     office practices. Our overall objective is to identify an effective and efficient strategy~     for decreasing the contribution of primary care clinicians to the emergence of~     antimicrobial-resistant bacteria in the community and to disseminate widely those strategies~     found to be effective and sustainable.~      We hypothesize that implementation of a clinician decision support system, with an active~     education component, will reduce the inappropriate use of antibiotics in primary care office~     practices. Our hypothesis is based on the premise that most inappropriate prescribing is the~     result of multiple factors that include difficulty in distinguishing a benign, self-limited~     viral infection from a more serious bacterial infection; overdiagnosis of a bacterial~     infection in cases where there is clinical uncertainty as to the true nature of the illness;~     and constraints on the time available for clinicians to explain to patients the nature of the~     illness and the reasons an antibiotic is not indicated.~      The focus of this proposal will be to compare the impact of clinical decision support and~     active education to no intervention for enhancing the appropriate use of antimicrobials for~     common outpatient infections. In this randomized control trial, primary care providers~     participating in the intervention arm will receive active education coupled with the~     implementation of a clinical decision support tool, while providers in the control arm will~     have no intervention. At the end of the study, providers in the control arm will receive a~     thorough analysis of their antibiotic prescribing patterns and suggested opportunities for~     improvement, as well as access to the intervention tools once the study has ended.~      Our interdisciplinary team will integrate novel methods in implementation science with~     clinical and laboratory expertise in infectious diseases, antimicrobial stewardship, primary~     care, information technology, performance improvement, health services research, and~     biostatistics. The Specific Aims are constructed to validate our hypothesis in the primary~     care setting by demonstrating two results of our intervention strategy:~        1. Reduced use of antibiotics to treat conditions for which those drugs are known not to be~          effective~        2. Decreased prescribing of broad-spectrum antibiotics to treat common bacterial~          infections.~      The degree of impact in terms of prescriptions per 100 visits for each targeted outpatient~     infection will be compared with active education and clinical decision support versus no~     intervention. The study will be able to measure the value of clinical decision support with~     active education that will inform future efforts in disseminating outpatient antibiotic~     stewardship interventions.~   "
188291|NCT01099930|"~     Multiple sclerosis is an autoimmune disease. We are studying whether high dose chemotherapy~     and autologous stem cell transplant can replace the autoreactive immune system and if this~     reduces clinical inflammatory disease in the central nervous system (CNS). A second goal is~     to examine whether there is long-term stabilization or improvement in disability scores if~     the inflammatory disease is controlled.~   "
188292|NCT01099917|"~     Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York~     Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of~     a medicinal mushroom extract called Maitake (pronounced my-tock-e).~      Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake~     does not kill cancer cells directly. It is believed to work through the immune system (the~     body's defense system against infection). Our test tube, animal and human dose determining~     studies show that Maitake can enhance immune function. We are conducting this study to see~     whether Maitake improves the neutrophil count and function in patients with MDS. The~     neutrophils are white blood cells which help to fight infection.~   "
188293|NCT01099904|"~     This open-label, parallel group study will evaluate the effect of renal function on the~     pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and~     assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or~     females with either normal renal function or mild or moderate renal impairment will receive~     RO5024048 orally for 5 days. Target sample size is <50.~   "
188294|NCT01099891|"~     The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis~     in patients receiving the radiation therapy or the concurrent chemo-radiotherapy~   "
188295|NCT01099878|"~     The aim of this study is to determine whether a short-term of FES assisted cycling in stroke~     patients can reduce the muscle tone of the affected leg immediately and the influence the~     postural control of the subjects.~   "
188296|NCT01099865|"~     The UKPDS risk score is recommended to assess global risk for future coronary heart disease~     (CHD) events in primary prevention. Recently, high-sensitivity C-reactive protein (hsCRP) has~     emerged as a strong independent risk factor for CHD. 18F-fluorodeoxyglucose (FDG) positron~     emission tomography (PET) is a promising imaging technique for the evaluation of vascular~     inflammation that reflects vulnerable atherosclerotic plaque.~   "
188297|NCT01099852|"~     Arbovirus is term used to refer to a group of viruses that are transmitted by blood-feeding~     arthropods. The word arbovirus is an acronym (Arthropod-Borne virus). There are hundred which~     have been shown to cause disease in humans. The incubation period is short usually limited~     between 1 and 15 days. Among case in which symptoms do appear, the most common clinical~     features of infection are 4: algo-eruptive (dengue, chikungunya, Zika virus disease...),~     hemorrhagic fever (dengue, yellow fever, Crimean-Congo hemorrhagic fever), neurological (West~     Nile virus disease, Zika virus disease, Japanese encephalitis.) or arthritic afflictions,~     (Chikungunya, O'nyong nyong…).~      Dengue is a mosquito-born viral disease caused by four different serotypes of dengue virus~     (DENV). Dengue fever (DF) is defined by the sudden onset of fever associated with non~     specific constitutional symptoms, recovery occurring spontaneously after three to seven days.~      The infection can sometimes progress to dengue hemorrhagic fever (DHF), a disease~     characterized by a transient increase in vascular permeability provoking a plasma leakage~     syndrome. DHF can be complicated by shock and internal hemorrhage. Other rarer but~     potentially life-threatening complications include encephalitis, hepatitis, rhabdomyolysis,~     and myocarditis.~      There is currently no way of predicting the outcome of DF or DHF, and the World Health~     Organisation (WHO) classification lacks sufficient sensitivity and specificity to recognize~     and guide the management of severe forms of dengue. The pathophysiology of these severe forms~     is also poorly known, but it involves both host characteristics (immunological facilitation~     in case of new infection by a different serotype, and genetic factors), and viral factors.~      . Since the early 2000s, the French West Indies and French Guiana have become hyperendemic~     for dengue, with simultaneous circulation of the four serotypes, regular large outbreaks, and~     severe dengue including fatalities.~      Chikungunya is a re-emerging alphavirus causing massive epidemics in Africa, in the Indian~     Ocean, and Southeast Asia. The first autochthonous cases of chikungunya were described in~     French Antilles in November 2013. The disease typically consists of an acute illness like~     dengue fever, characterized by abrupt onset of a high-grade fever, followed by~     constitutionals symptoms, poly-arthritis and skin involvement. Usually, the illness resolves~     within à few weeks: four to six weeks. However, severe clinical forms in early stage~     (encephalopathy, exacerbation of previous complaints..) may appear and chronic forms such as~     incapacitating arthralgia which affect 40 to 60% of patients with confirmed chikungunya.~      In France, others arboviruses may cause severe emerging and re-emerging infectious diseases~     like Zika or West Nile. In non-immunized population these emerging diseases may cause~     outbreaks with specific severe clinical complications from each arbovirus~     (polyradiculoneuritis for Zika virus infection, encephalitis for West Nile virus infection…)~      West Indies- French Guiana French interministerial mission on emerging infectious diseases,~     coordinated by Professor Antoine Flahault, recommended such studies and underlined the~     excellent situation of Guyana for this type of study, and as an interface for clinical and~     basic research.~      This epidemiological situation calls for large prospective multicenter cohort studies to~     characterize severe forms of arbovirus infections, to seek predictive factors, and to~     investigate the pathophysiology of the diseases .~   "
188298|NCT01099839|"~     This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in~     healthy volunteers.~   "
188299|NCT01099826|"~     Colorectal cancer screening remains lower than optimal. The purpose of this study was to test~     the efficacy of phone-based motivational interviewing versus tailored communication versus~     usual care in increasing CRC screening in primary care clinics.~   "
188300|NCT01099813|"~     This project proposes to measure delay to admission to Intensive Care (ICU). Delays in the~     United Kingdom NHS are widely reported possibly because there are fewer ICU beds than in many~     other developed health care systems. Patients are inevitably admitted with more severe~     illness. Scores measuring this severity are used for research and benchmarking. However,~     although patients deteriorate over time, severity is probably neither directly nor linearly~     related to the duration of illness. Instead it is likely that the characteristics of severity~     change with time. In sepsis there is good biological evidence of this so that there is an~     early pro-inflammatory stage followed by later changes in metabolic, neuroendocrine, and~     immune systems. In addition to examining the effect of duration of illness prior to ICU~     admission, the investigators will also therefore investigate how severity changes over time.~      SPOT(Light) is a prospective observational study. Treatment is not modified in anyway.~     Patients evaluated on the ward by critical care outreach teams, and subsequently admitted to~     critical care will be eligible. Severity of illness at the time of initial evaluation and~     eventual admission will be compared, and the effect of the duration of illness on 90 day~     survival investigated.~   "
188314|NCT01099631|"~     The working hypothesis is that oral administration of an attenuated strain of Salmonella~     typhimurium is safe and efficacious for patients with unresectable hepatic metastasis from a~     solid tumor cancer. The primary objective of the study is to determine the MTD of Samonella~     typhimurium in the treatment.~   "
188381|NCT01098760|"~     This is a single-arm, open-label and post-authorization study to evaluate the safety and~     efficacy profile of sorafenib and to evaluate Child-Pugh status progression in subjects with~     advanced HCC treated with sorafenib in Taiwan.~      In a subgroup of patients (hand-foot skin reaction (HFSR) study subgroup), this study also~     aims to test if topical corticosteroids as preventive counter-measure applied to hands and~     feet for the first 3 weeks during sorafenib treatment reduce incidence and severity of HFSR~     compared to a matching, corticosteroid-free cosmetic ointment, measured over the first 3 and~     6 weeks of sorafenib treatment.~   "
188301|NCT01099800|"~     This interdisciplinary multi-level study moves the research in asthma health disparities from~     descriptive studies of individual constructs and contexts to testing an integrated,~     multi-factorial model among Latino families and children with asthma. The investigators seek~     to gain a more thorough understanding of the interaction of individual characteristics,~     cultural and experiential factors, social-environmental context, and healthcare system~     factors on parents' illness representations, use of CAM and controller medications, and~     children's asthma health outcomes.~      This will be a one-year longitudinal, multi-site (Phoenix, AZ and Bronx, NY) study among~     samples of Mexican (N=300) and Puerto Rican (N=300) parents and children aged 5-12 who have~     asthma.~      Aim #1: Are there differences in illness representations between Mexican and Puerto Rican~     parents due to social and contextual factors (i.e., acculturation, education, parental age,~     poverty, child's illness duration, household members with asthma, and parent-healthcare~     provider relationship)?~      Aim #2: Are disparities in asthma control between Mexican and Puerto Rican children due to~     differences in parents' treatment decisions (CAM and controller medication use) and changes~     in illness representations over a one year period after controlling for the effects of~     acculturation, social and contextual factors, environmental triggers, and advice received~     from others?~   "
188302|NCT01099787|"~     To explore the predictive value of alarm signs (red flags) for a diagnosis of functional~     gastrointestinal disorders (FGID) in children.~      To assess the natural history of pain predominant functional gastrointestinal disorders~     (FGID) in newly diagnosed pediatric patients.~      To document the benefit of various treatment regimens currently employed in managing FGID.~      To assess the short- and long-term impact of various FGID regimens.~      To allow physicians to gain a better understanding of the epidemiology of FGID.~      Hypothesis:~      There are presenting symptoms or results from diagnostic tests that are more likely to~     associated with conditions different from FAP or IBS.~      Symptoms of children with FAP/IBS change overtime regardless of the treatments used.~   "
188303|NCT01099774|"~     This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B~     ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12~     weeks in patients with glaucoma or ocular hypertension~   "
188304|NCT01099761|"~     The purpose of this study is to determine if ACE-031 is safe and well-tolerated in boys with~     Duchenne Muscular Dystrophy (DMD) and to select the optimal doses of ACE-031 in terms of~     safety and pharmacodynamic (PD) activity for designing future studies. [Note: This study was~     terminated based on safety data]~   "
188305|NCT01099748|"~     The objective of this study is to estimate the effect of lersivirine on the pharmacokinetics~     of R-methadone and S-methadone and to investigate the safety and tolerability of lersivirine~     when co-administered with methadone. Symptoms of methadone withdrawal will also be assessed.~   "
188306|NCT01099735|"~     This trial is enrolling patients who are already being seen at OHSU weight loss clinic or~     have been referred for clinical reasons by their physician to the OHSU weight loss clinic and~     are going to have a esophageal manometry that would be paid for by their insurance company~     for clinical reasons.~      In patients undergoing weight loss surgery investigators plan to study the effect of~     continuous positive airway pressure during a esophageal manometry.~   "
188307|NCT01099722|"~     A comparator study to assess safety and efficacy of Flutiform® compared with symbicort~     turbohaler in asthma patients with moderate to severe persistent, reversible asthma.~   "
188308|NCT01099709|"~     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10~     mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.~   "
188309|NCT01099696|"~     This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a~     probiotic for abdominal discomfort and bloating in healthy subjects.~   "
188310|NCT01099683|"~     A total of 26 healthy elderly male and female subjects will receive both 10 mg NRL001 in a 2~     g rectal suppository and placebo in this double-blind, cross-over study. The order of~     treatment will be randomised, with a minimum washout period of 3 days between doses. An end~     of study assessment will be conducted at least 7 days after administration of the last~     treatment.~      The pharmacokinetics of NRL001 will be determined prior to, and after, dosing.~     Pharmacodynamics will be examined using a three lead Holter monitor during both treatment~     periods. Adverse Events, vital signs, ECGs and clinical laboratory parameters will be~     collected, tabulated, reviewed and recorded throughout the study.~   "
188311|NCT01099670|"~     Healthy subjects will receive NRL001 or placebo once daily for 14 days. The four treatment~     groups, shown below, will each consist of 12 subjects:~      Group 1; Nine subjects will receive a dose of 7.5 mg NRL001 in a 2 g suppository and three~     will receive matching placebo.~      Group 2; Nine subjects will receive a dose of 10 mg NRL001 in a 2 g suppository and three~     will receive matching placebo.~      Group 3; Nine subjects will receive a daily dose of 12.5 mg NRL001 in a 2 g suppository and~     three will receive matching placebo.~      Group 4; Nine subjects will receive a daily dose of 15 mg NRL001 in a 2 g suppository and~     three will receive matching placebo.~      The dosing of each group will be completed prior to the next group being dosed. Dose~     escalation will be dependent on a positive assessment of the safety profile of the preceding~     group by the Safety Monitoring Board.~      The pharmacokinetics of NRL001 will be determined on Days 1, 7 and 14. Pharmacodynamics will~     be examined using a three lead Holter monitor at screening and at intervals throughout the~     study period. Adverse events, vital signs, ECGs and clinical laboratory parameters will be~     collected, tabulated, reviewed and recorded throughout the study.~   "
188312|NCT01099657|"~     We would like to determine how well hypnosis works when induced through virtual reality~     medium for patients who have suffered a major burn injury in the past two years and suffer~     from chronic pain. These patients are coming back to the outpatient burn and plastic clinic~     at Harborview Medical Center for routine follow-up. We think that patients will find~     VR-Hypnosis interesting, and it will help them relax and feel less pain.~   "
188345|NCT01099228|"~     The primary aim of this project is to determine, what fraction of individuals with~     neuroendocrine tumors would show substantially improved tumor dosimetry with combined agent~     therapy compared to best single agent therapy and determine the magnitude of the potential~     tumor radiation dose increase.~   "
188382|NCT01098747|"~     This study will compare the pain relieving effect of a single-dose of a novel ibuprofen~     formulation to placebo and two formulations of standard ibuprofen in the treatment of~     post-surgical dental pain following wisdom tooth (third molar) removal.~   "
188315|NCT01099618|"~     The study intends on enrolling 48 subjects with diabetes. Diabetic subjects that no longer~     need insulin will be randomly placed (like the flip of a coin) on a diabetes pill called~     metformin, a diabetes pill called sitagliptin or a placebo pill (a pill without active~     medication). Subjects on pills will be followed for 3½ years and undergo blood tests at~     specified intervals to assess their ability to make insulin. These studies will allow a~     better understanding of the factors that lead to high blood sugar in patients with~     ketosis-prone diabetes mellitus (KPDM) and direct the best diabetes treatment for this~     patient population.~      Hypothesis: Metformin therapy or sitagliptin therapy compared to placebo, will improve β-cell~     function, insulin sensitivity, and allow for a longer period of time prior to encountering an~     insulin-deficient relapse after discontinuation of insulin therapy.~   "
188316|NCT01099605|"~     Over the past decade, continuous wound infiltration systems have been introduced to treat a~     variety of post-surgical pain. These systems, commonly referred to pain pumps by patients,~     possess a catheter(s) attached to a reservoir of local anesthetic that directly infuses into~     the surgical site to provide local pain control thus avoiding the common and less desirable~     systemic effects of oral narcotic pain medication. Due to its portability, another benefit~     associated with these wound infiltration systems is its use as an outpatient pain control~     modality. Despite the apparent benefits, the verdict on the system's effectiveness in~     treating pain - throughout a variety of surgical fields - varies between very effective in~     reducing post-operative pain and reducing overall narcotic consumption for several days to~     completely ineffective with no reported changes in perceived pain or overall narcotic use.~      Through a randomized trial comparing plain saline to a common local anesthetic, The~     investigators hope to evaluate the effectiveness of these pain pumps as an outpatient~     modality for pain management following hemorrhoidectomy patients. The investigators~     hypothesize that there will be a significant benefit in pain relief with the use of these~     pumps.~   "
188317|NCT01099592|"~     Depression is frequently seen in cardiac patients. It has been shown that depression often~     has a negative impact on the course of coronary disease. More recently, research has~     demonstrated that some antidepressants can be used safely to treat depressed coronary~     patients. Although the majority of patients improve substantially with antidepressant~     treatment, a significant proportion do not respond to antidepressants. This project seeks to~     better understand why depression does not improve equally well in all patients. Ultimately,~     the hope is to improve the treatments available to people affected by both cardiac disease~     and depression, and to help select the best type of treatment in advance for each individual~     based on his or her personal history, and biological characteristics.~   "
188318|NCT01099579|"~     The purpose of this study is to determine whether atazanavir powder combined with ritonavir~     is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to <6~     years of age.~   "
188319|NCT01099566|"~     Severe sepsis still carries a high mortality rate despite advantages in intensive care~     medicine and antimicrobial therapy. The inflammatory and procoagulant host response to~     infection are intricately linked and interactions between platelets, leukocytes and the~     endothelium play a central role in the pathogenesis of septic shock and disseminated~     intravascular coagulation (DIC). Interestingly, one key player cell in coagulation, i.e. the~     platelet, has been somewhat neglected as to its position in the pathogenesis of coagulation~     abnormalities in sepsis. However, thienopyridines, irreversible platelet P2Y12 ADP-receptor~     antagonists, e.g. prasugrel, could potentially provide beneficial anticoagulatory and~     antiinflammatory effects: P2Y12 ADP-receptor antagonists reduce TF-induced coagulation~     activation in various ex vivo and in vitro models. Moreover, various lines of evidence~     indicate that thienopyridines may block platelet leukocyte interactions and thereby reduce~     the propagation of the coagulation and inflammation process.~      LPS-infusion in healthy volunteers provides a standardized model to safely study non overt~     DIC and to document possible effects of therapeutic and prophylactic interventions.~      The investigators hypothesize that thienopyridines, irreversible platelet P2Y12 ADP-receptor~     antagonists, may blunt TF-triggered coagulation activation in humans, which will be studied~     in a TF-dependent coagulation model in humans.~   "
188320|NCT01099553|"~     The investigators goal is to improve bowel preparations with an educational video on the~     Center for Digestive Disorders (CDD) website that explains the steps required for bowel~     preparation for those patients undergoing screening colonoscopies. The video will focus on~     explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the~     pre-colonoscopy diet, and the instructions for completing the laxative. In a randomized~     fashion, patients in the control group will receive the standard written bowel preparation~     instructions, while patients in the intervention group will receive standard written~     instructions plus a link to watch the instructional video. The investigators hypothesize that~     an educational tool that provides visual examples of a good and poor preparation, examples of~     the pre-colonoscopy diet, and an explanation of how to administer the laxative will lead to~     improved patient compliance and a better bowel preparation. In addition, the investigators~     hypothesize that a better quality bowel preparation will improve detection of colonic polyps~     and fewer recommendations for repeat colonoscopy based solely on inadequate bowel~     preparation.~   "
188321|NCT01099540|"~     To determine the response rate of pazopanib when administered as monotherapy in patients with~     unresectable neuroendocrine tumor.~   "
188322|NCT01099527|"~     Capecitabine is an oral fluoropyrimidine that has been shown to be effective in the treatment~     of metastatic gastric and colorectal cancer patients. On the basis of capecitabine-based~     chemotherapy which is accepted as a standard regimen in gastric cancer, we will perform the~     phase I/II study with all-oral regimen of RAD001 with capecitabine for these refractory~     gastric cancer patients.~   "
188346|NCT01099215|"~     The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic~     cellular therapy, delivered as a single injection following percutaneous transluminal~     (balloon) angioplasty and stent placement for the treatment of peripheral artery disease~     (PAD).~   "
188347|NCT01099202|"~     The goal of this clinical research study is to learn if Procrit (epoetin alfa) will decrease~     the need for blood transfusions in patients with Acute Lymphocytic Leukemia (ALL),~     Lymphoblastic Lymphoma (LL), or Burkitt's who are receiving chemotherapy. Another goal is to~     study the remission rates in patients with cancer who have received treatment with epoetin~     alfa.~   "
188323|NCT01099514|"~     Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma~     (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT~     mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas~     (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase~     inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both~     imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone~     and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal~     tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and~     56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553).~      Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT~     mutations.~   "
188324|NCT01099501|"~     This is a single-center, prospective, randomized, comparative, double-blind controlled~     clinical study mend to assess the effect of enteral feeding with Oxepa (a fish oil-based~     nutrition), compared to an isocaloric control, on oxygenation and clinical outcomes in~     mechanically ventilated trauma patients.~      The study population will be adults admitted to the ICU due to multiple-trauma or head trauma~     as a result of a gun shut, motor vehicle accidents, fall, workplace accident etc.~   "
188325|NCT01099488|"~     The purpose of this study is to develop immunological assays on blood samples.~   "
188326|NCT01099475|"~     In order to prevent excessive blood loss during liver surgery, an intermittent Pringle~     manoeuvre (IPM) can be applied. This implies a temporary clamping of the portal vein and~     hepatic artery in the hepatoduodenal ligament in order to occlude hepatic inflow. The optimal~     duration of the IPM is unknown. This randomized controlled trial aimed to analyse differences~     in hepatocellular damage after 15 minutes or 30 minutes IPM during liver surgery for primary~     or secondary liver tumours.~   "
188327|NCT01099462|"~     Ibuprofen, the active ingredient in Nurofen and Advil, is a commonly used drug in children.~     There is very limited data about Ibuprofen concentrations in the cerebro spinal fluid (CSF).~     The objective of the current study is to describe concentrations of ibuprofen in the CSF of~     infants and children after administration of ibuprofen. We will study infants presenting to~     the Emergency Department (ED) with fever who received ibuprofen. A complete sepsis workup~     including sampling of blood and CSF is conducted in cases of suspected meningitis. We will~     measure ibuprofen in the blood and CSF obtained during the sepsis workup. A better~     understanding of the pharmacokinetics of ibuprofen and its penetration into the CSF will~     unable us to suggest more accurate dosing guidelines, and to better predict the effects of~     this commonly used drug.~   "
188328|NCT01099449|"~     RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may~     prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration~     schedule of calcium gluconate and magnesium sulfate is more effective in preventing~     neurotoxicity.~      PURPOSE: This randomized phase III trial is studying different administration schedules of~     calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in~     patients with colon cancer or rectal cancer receiving oxaliplatin-based combination~     chemotherapy.~   "
188329|NCT01099436|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,~     docetaxel, and zoledronic acid, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination~     chemotherapy is more effective when given together with zoledronic acid in treating patients~     with breast cancer.~      PURPOSE: This randomized phase III trial is studying giving doxorubicin hydrochloride~     together with cyclophosphamide and docetaxel to see how well it works with or without~     zoledronic acid in treating patients with large resectable or locally advanced breast cancer.~   "
188330|NCT01099423|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib~     malate before surgery may make the tumor smaller and reduce the amount of normal tissue that~     needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that~     remain after surgery. It is not yet known whether undergoing immediate surgery or surgery~     after sunitinib malate is more effective in treating patients with metastatic kidney cancer.~      PURPOSE: This randomized phase III trial is studying immediate surgery to see how well it~     works compared with surgery after sunitinib malate in treating patients with metastatic~     kidney cancer.~   "
188331|NCT01099410|"~     The purpose of this study is to compare the ability of two types of white blood cells to eat~     dead host cells, and how this process affects their ability to protect the body from~     infection. The two cell types are monocytes, a cell in the bloodstream, and alveolar~     macrophages, a cell in the lung that is ultimately derived from monocytes~   "
188332|NCT01099397|"~     The purpose of this study is to determine if, in a subset of patients treated with a~     beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour~     oral glucose tolerance test (OGTT) compared to fasting glucose measurement.~   "
188348|NCT01099189|"~     Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a~     dialysis machine. In order to be connected to the machine an operation is often performed to~     join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula.~     The fistula causes an increase in the flow of blood through the vein and the vein reacts to~     this by becoming bigger and thicker, making it easier to connect the patient to the machine.~      The success rate for the operation is relatively low and only approximately 65 from every 100~     operations is still working after a year. It is thought that one factor that may cause~     problems with the fistula is the ability of the vein to stretch in response to increased~     blood flow. Previous research has shown that veins in kidney failure patients look different~     to those of people whose kidneys are working when viewed under a microscope.~      The investigators aim to study the structure of the vein that is used in making fistulas with~     a microscope and also to test it in an engineering laboratory to see how much it will~     stretch. The investigators hope that gaining information about the structure of the vein and~     its ability to stretch will help determine what it is about the vein that affects how well it~     works as part of a fistula. This information may help surgeons select the best possible vein~     in a given patient to give the best chance of a working fistula in the future.~   "
188333|NCT01099384|"~     Tobacco use among adolescents is a major public health problem in the United States. The~     prevalence of tobacco use among adolescents is currently highest among American Indians and~     Alaska Natives. Among Alaska Natives residing in the Yukon-Kuskokwim (Y-K) Delta region of~     western Alaska, approximately 29% of 11-14 year olds, and 63% of 15-18 year olds, use~     tobacco. No prior work has evaluated tobacco cessation interventions for Alaska Native~     adolescents.~      This proposal builds on the investigators successful partnership and 7 year track record of~     collaboration with the Y-K Delta Alaska Native community. The objective of this proposal is~     to develop and pilot test a novel, culturally-appropriate, behavioral treatment approach for~     tobacco cessation among Y-K Delta Alaska Native adolescents ages 12 to 17. The behavioral~     intervention will include an initial, 2 day, group-based program with follow-up support for 6~     weeks. Social cognitive (learning) theory is the conceptual basis for the proposed~     intervention. The investigators expect that as a result of this stage I project, the~     investigators will have developed a replicable, feasible, and acceptable intervention, the~     efficacy of which can be tested in future large-scale randomized clinical trials.~      This project will take place in two phases. In phase 1, the investigators will develop the~     intervention with feedback from a teen advisory group, and develop a counselor manual.~     Follow-up strategies will also be developed, pilot-tested, and refined. Twenty adolescents~     will complete the protocol, which will be refined in an iterative manner based on feedback~     from participants and counselors. Phase 2, consisting of a pilot clinical trial, will apply a~     group-randomized design with assessments at weeks 0 (baseline), 6, and 26. Eight villages~     will be randomized to receive either the behavioral intervention or control condition~     (written self-help materials + quitline referral). Ten adolescents will be enrolled from each~     village, for a total of 80 participants. The investigators will assess the feasibility and~     acceptability of the intervention, as determined by qualitative ratings of treatment~     acceptability, and recruitment and retention rates. The investigators will estimate the~     magnitude of the effect of the intervention compared to the control condition on the~     biochemically confirmed tobacco abstinence rate at weeks 6 and 26, and estimate the~     intra-class correlation coefficient (ICC). At week 6, the investigators will evaluate the~     effect of the intervention on changes from baseline on perceived social support,~     self-efficacy for stopping tobacco use, and other mechanisms of change consistent with the~     investigators theoretical framework. The overall health related objective is to develop~     effective treatment programs for Alaska Native youth that will ultimately reduce their risk~     of tobacco-related disease.~   "
188334|NCT01099371|"~     The purpose of this study is to determine whether:~        1. Progressive resistance training improves pain and disability~        2. Progressive Resistance training improves muscular strength, ability to walk and quality~          of life~   "
188335|NCT01099358|"~     The primary purpose of this study is to help answer the following research question(s):~        -  To see how the body absorbs, processes, and gets rid of cetuximab when the drug is taken~          in combination with cisplatin [pharmacokinetic (PK) analysis]~        -  To see if any drug interactions occur between cetuximab and cisplatin.~   "
188336|NCT01099345|"~     This is an observational, pilot, non-treatment study to evaluate and develop clinical~     variables for distinguishing female OAB subjects that have detrusor overactivity positive~     (DO+) nocturia from female OAB subjects that have detrusor overactivity negative (DO-)~     nocturia utilizing a sleep laboratory setting.~   "
188337|NCT01099332|"~     This trial aims to test the hypothesis that 1) a single dose of zinc cysteine in a~     proprietary gastro-retentive form will produce sustained blood levels of zinc giving a larger~     bioavailable amount of zinc than an FDA approved preparation of inorganic zinc acetate; and~     2) that the zinc cysteine gastro-retentive, sustained-release preparation will be better~     tolerated with significantly less gastrointestinal side effects than the zinc acetate~     capsules. The trial also tests the hypothesis that, after 6 months of once daily~     administration, the zinc cysteine subjects will show reduced serum non-ceruloplasmin copper.~     Additionally, subjects will perform tests of mental function,including the dementia rating~     scale, the Mini Mental Status Examination and the ADAS-cognitive performance test aimed at~     Alzheimer's status assessment. Tests will be administered at baseline, 3 and 6 months, and~     the performance results compared. Care-giver assessments will also be noted.~   "
188338|NCT01099319|"~     The purpose of this study is to assess the efficacy and safety of Renalof administration in~     the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical~     evaluation in elderly patients (aged >65 years). The duration of this double-blind placebo~     controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be~     recruited and randomized for the study is 40.~   "
188339|NCT01099306|"~     This study devised an experimental focused pharmaceutical care program, allowed a clinical~     pharmacist to work in a physician office to assess and manage patients' metabolic syndrome~     status and its individual components. This study described the clinical benefits of~     physician- clinical pharmacist interaction in achieving improved glycemic control, lipid and~     blood pressure measurements, involving medication, diet, physical activity and patient heath~     care counseling.~   "
188340|NCT01099293|"~     It has been observed that patients with cirrhosis present a generalized state of~     vasoconstriction as an homeostatic response to splanchnic arteriolar vasodilatation. On~     progression of the disease, vascular regulation is mismatched, causing altered systemic blood~     flow and lose in the cerebrovascular reactivity.~      The investigators hypothesize that the altered cerebrovascular reactivity induces~     neurological disturbances related to hepatic encephalopathy and, therefore, the existence of~     a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy.~   "
188341|NCT01099280|"~     Prelabor rupture of membranes (PROM) is most commonly defined as rupture of membranes before~     the onset of labor and occurs in 8% of term pregnancies. A prolonged interval from rupture of~     membranes to delivery is associated with an increase in the incidence of chorioamnionitis and~     neonatal sepsis. The management of the term patients with PROM, especially those with an~     unfavorable cervix, remains controversial. Management options to choose from are immediate~     induction of labor versus delayed induction or expectant management. Several reports have~     detailed an increase in maternal and neonatal morbidity with expectant management, whereas~     active management leads to a shorter interval from PROM to delivery, reducing the risk of~     postnatal infections. In addition, active management is preferred by patients.~      The investigators know that, neonatal intensive care admission, variable decelerations, and~     primary cesarean delivery rates are positively correlated with a longer~     admission-to-labor-onset interval in women with PROM . So, to reduce the induction to~     delivery times, concurrent oxytocin infusion with dinoprostone vaginal pessary use for labor~     induction in women with PROM may be beneficial. Several studies have shown shorter~     induction-to-delivery interval with concurrent oxytocin infusion with prostaglandin agent at~     initiation of labor . However, in these studies, there is a a paucity information in PROM~     labor induction. Only one randomized control trial have compared the efficacy of concurrent~     dinoprostone and oxytocin and oxytocin alone in women with term PROM . This study indicated~     that concurrent vaginal dinoprostone and intravenous oxytocin conferred no advantage over~     intravenous oxytocin alone for the outcomes of interest, including length of labor patient~     satisfaction or risk for cesarean delivery. Unfortunately, this study was limited by small~     sample size.~      The aims of this randomized study was to compare two protocols (oxytocin vs.~     sustained-release dinoprostone followed six hours later by oxytocin) for induction of labour~     in women with PROM at term and an unfavorable cervix.~   "
188342|NCT01099267|"~     Multi-center, survival data collection in subjects previously enrolled in study NCT00065156~     (Celgene Protocol CC-5013-MDS-003).~   "
188343|NCT01099254|"~     The Trendelenburg position is used to distend the central veins, improving both success and~     safety of vascular cannulation. The purpose of this study is to measure the cross-sectional~     area of the internal jugular vein (IJV) in three different positions, using surface~     ultrasound.~   "
188344|NCT01099241|"~     Ultrasound may be useful for noninvasively determining the central venous pressure. We intend~     to compare the clinical examination of the neck veins; ultrasound delineation of the internal~     jugular vein; and the central venous pressure measured with an intravascular catheter.~   "
188350|NCT01099163|"~     Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers~     that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA,~     cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by~     delta-9 desaturation of the co-product vaccenic acid (trans-11-18:1) in most mammalian~     tissues including man. The second most abundant isomer of CLA is the trans-10, cis-12-18:2~     form. Observations clearly emphasize that differences exist between mammalian species in~     their response to CLAs with mice being the most sensitive. The majority of studies on body~     compositional effects (i.e. fat loss, lean gain), on cancer and cardiovascular disease~     attenuation, on insulin sensitivity and diabetes and on immune function have been conducted~     with a variety of animal models. Recent studies indicate that some but not all of the effects~     observed in animals also pertain to human volunteers. Reports of detrimental effects of CLA~     intake appear to be largely in mice and due mainly to the trans-10, cis-12 isomer.~     Suggestions of possible deleterious effects in man due to an increase in oxidative lipid~     products (isoprostanes) with trans-10, cis-12 CLA ingestion require substantiation.~     Unresponsiveness to antioxidants of these non-enzymatic oxidation products casts some doubt~     on their physiological relevance. We hypothesized that supplementation with CLA + an~     antioxidant (vitamin E) in patients with diabetes mellitus may have beneficial effects on~     glycemic control and insulin sensitivity.~   "
188351|NCT01099150|"~     Cardiovascular disease is a major cause of mortality worldwide and responsible for one out of~     three global deaths. A main characteristic of cardiovascular disease is impaired blood flow~     and formation of blood clots. Platelets are clot-forming cells responsible for the prevention~     of bleeding. However, in disease conditions they may be overly activated, promoting blood~     clots and blockage of blood vessels.~      Consumption of diets rich in fruits and vegetables decreases mortality from cardiovascular~     disease through a number of mechanisms, including the prevention of platelet clotting and~     aggregation. There is some evidence suggesting that platelet aggregation may be modulated~     through a group of compounds known as flavan-3-ols, which are found in various foods, and~     especially in cocoa. However, the mechanisms by which those compounds affect platelet~     function are not yet fully understood. We designed a human study assessing the mechanisms by~     which flavan-3-ols from cocoa beneficially affect platelet function and the platelet~     proteome.~   "
188352|NCT01099137|"~     Dual combination therapy with metformin and sulphonylurea is the most commonly used~     combination regimen to treat patients with type 2 diabetes. But, treatment with the dual~     combination therapy is often unsuccessful at achieving glycaemic control in patients with~     type 2 diabetes. In this setting, use of insulin is often the next therapeutic step.~      Recently, dipeptidyl peptidase (DPP)-IV inhibitor is increasingly being used in clinical~     practice. It is well established that DPP-IV inhibitor improve glycemic control in patients~     with type 2 diabetes.~      But, there have been few studies about the glucose lowering effect of DPP-IV inhibitors~     (vildagliptin) in Type 2 diabetes patients on the dual combination therapy with a~     sulfonylurea agent and metformin.The researchers hypothesized that DPP-IV inhibitor as add-on~     therapy to combination of a sulfonylurea agent and metformin have favorable glucose lowering~     effect in type 2 diabetic patients. The researchers plan to investigate the change in HbA1C~     and fasting glucose of 24 weeks treatment with vildagliptin (DPP-IV inhibitor) in combination~     with a sulfonylurea agent and metformin in type 2 diabetic patients.~   "
188353|NCT01099124|"~     The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in~     advanced NSCLC.~   "
188354|NCT01099111|"~     This clinical trial hypothesize that Gut Microbiota (bacteria, viruses, fungi)play a major~     role in the occurrence and progression of many chronic gastrointestinal diseases like~     Irritable Bowel Syndrome, Inflammatory Bowel Diseases and Colo-Rectal Cancer.~      Hence, aims to study the spectrum of such microbiota in these patients as compared to normal~     subjects, by utilizing metagenomic techniques rather than cultural methods.~   "
188355|NCT01099098|"~     We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this~     study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma~     release assay and tuberculin skin tests in patients with old healed TB.~   "
188356|NCT01099085|"~     Based on antitumor activity of statin, we designed a phase III study of capecitabine/CDDP~     chemotherapy plus a low-dose simvastatin that is equivalent to cardiovascular dose in~     advanced gastric cancer patients.~   "
188357|NCT01099072|"~     Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioural disorder~     of childhood. The investigators hypothesized that carnitine would be beneficial for treatment~     of ADHD, and this could be evaluated in a double blind, randomized, parallel group comparison~     of carnitine+methylphenidate and methylphenidate +placebo.~      This will be a six-week, parallel group, randomized clinical trial undertaken in an~     outpatient child and adolescent clinic at Roozbeh Psychiatric Hospital in Tehran, Iran during~     April 2010-May 2010.~      40 male and female subjects, ages 6 to 17 years with a Diagnostic and Statistical Manual,~     Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD will be study population of this~     trial. At screening, investigators conduct a psychiatric evaluation with the DSM-IV-TR~     criteria for ADHD and the Kiddie Schedule for Affective Disorders and Schizophrenia-Present~     and Lifetime diagnostic interview and perform a complete medical history and physical~     examination.~      The diagnosis of ADHD will be confirmed by a child and adolescent psychiatrist before~     participants will be initiated into the study. All patients will be newly diagnosed. Parents~     were carefully interview and ask to rate the severity of the DSM-IV-TR ADHD symptoms that~     their children display at home. Children will be excluded if they have a history or current~     diagnosis of pervasive developmental disorders, schizophrenia or other psychiatric~     disorders(DSM-IV axis I); any current psychiatric comorbidity that required pharmacotherapy;~     any evidence of suicide risk and mental retardation (I.Q. <70). In addition, patients will be~     excluded if they have a clinically significant chronic medical condition, including organic~     brain disorder, seizures and, current abuse or dependence on drugs within 6 months.~     Additional exclusion criteria will be hypertension, hypotension. To participate, parents and~     children have to be willing to comply with all requirements of the study. After a description~     of the procedures and purpose of the study, written informed consent will be obtained from~     each patient's parent or guardian. Informed consent will receive before the administration of~     any study procedure or dispensing of study medication in accordance with the ethical~     standards of the investigative site's institutional review board and with the Helsinki~     declaration of 1975, as revised in 2000. The protocol will be approved by the Institutional~     Review Board (IRB) of Tehran University of Medical Sciences.~      Patients will be randomized to receive a carnitine+methylphenidate and methylphenidate~     +placebo in a 1: 1 ratio using a computer-generated code.~      All study subjects will be randomly assigned to receive treatment using methylphenidate at a~     dose of 20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)+~     Carnitine 500-1500 mg/day (depending on weight ) or methylphenidate at a dose of 20-30 mg/day~     depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)+ Placebo for a 6 week~     double blind, randomized clinical.~      The principal measure of outcome will be the Parent and Teacher ADHD Rating Scale-IV that has~     been used extensively in Iran in school-age children and provides valid measures of~     behavioral abnormality and attention trial.~      Side effects will be systematically recorded throughout the study and will be assessed using~     a checklist that comprises 20 side effects including psychic, neurologic, autonomic and other~     side effects, administered by a child psychiatrist on days 7, 21and 42. Side effects,~     administered by a child psychiatrist on days 7, 21and 42.~   "
188358|NCT01099059|"~     Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioural disorder~     of childhood. The investigators hypothesized that amantadine would be beneficial for~     treatment of ADHD, and this could be evaluated in a double blind, randomized, parallel group~     comparison of amantadine and ritalin.~      This will be a six-week, parallel group, randomized clinical trial undertaken in an~     outpatient child and adolescent clinic at Roozbeh Psychiatric Hospital in Tehran, Iran during~     April 2010-May 2010.~      50 male and female subjects, ages 6 to 17 years with a DSM-IV-TR diagnosis of ADHD will be~     study population of this trial. At screening, investigators conduct a psychiatric evaluation~     with the DSM-IV-TR criteria for ADHD and the Kiddie Schedule for Affective Disorders and~     Schizophrenia-Present and Lifetime diagnostic interview and perform a complete medical~     history and physical examination.~      The diagnosis of ADHD will be confirmed by a child and adolescent psychiatrist before~     participants will be initiated into the study. All patients will be newly diagnosed. Parents~     were carefully interview and ask to rate the severity of the DSM-IV-TR ADHD symptoms that~     their children display at home. Children will be excluded if they have a history or current~     diagnosis of pervasive developmental disorders, schizophrenia or other psychiatric~     disorders(DSM-IV axis I); any current psychiatric comorbidity that required pharmacotherapy;~     any evidence of suicide risk and mental retardation (I.Q. <70). In addition, patients will be~     excluded if they have a clinically significant chronic medical condition, including organic~     brain disorder, seizures and, current abuse or dependence on drugs within 6 months.~     Additional exclusion criteria will be hypertension, hypotension. To participate, parents and~     children have to be willing to comply with all requirements of the study. After a description~     of the procedures and purpose of the study, written informed consent will be obtained from~     each patient's parent or guardian. Informed consent will receive before the administration of~     any study procedure or dispensing of study medication in accordance with the ethical~     standards of the investigative site's institutional review board and with the Helsinki~     declaration of 1975, as revised in 2000. The protocol will be approved by the Institutional~     Review Board (IRB) of Tehran University of Medical Sciences.~      Patients will be randomized to receive amantadine or ritalin in a 1: 1 ratio using a~     computer-generated code.~      All study subjects will be randomly assigned to receive treatment using amantadine 100-150 mg~     depending on weight (100 mg/day for <30 Kg and 150 mg/day for >30 Kg) or ritalin at a dose of~     20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg) (group 2)~     for a 6 week double blind, randomized clinical.~      The principal measure of outcome will be the Parent and Teacher ADHD Rating Scale-IV that has~     been used extensively in Iran in school-age children and provides valid measures of~     behavioral abnormality and attention trial.~      Side effects will be systematically recorded throughout the study and will be assessed using~     a checklist that comprises 20 side effects including psychic, neurologic, autonomic and other~     side effects, administered by a child psychiatrist on days 7, 21and 42.~   "
188359|NCT01099046|"~     Attacks in Meniere's disease, characterized by vertigo and hearing loss, are well known to~     occur repeatedly under stressed environment. Hitherto, its pathology was revealed to be inner~     ear hydrops through human temporal bone studies in 1938. For the pathogenesis of inner ear~     hydrops resulting in Meniere's attacks, plasma vasopressin elevation due to stress and V2~     receptor overexpression in the inner ear could be essential as a basis of this disease. In~     the present study, we'd like to find the effective and feasible way to reduce plasma~     vasopressin level in patients with Meniere's disease.~   "
188360|NCT01099033|"~     The study will examine potential biological and genetic mechanisms leading to hiatal and~     paraesophageal hernia formation in predisposed individuals. It is expected that these~     patients will have defects in the normal production and maturation of collagen and other~     connective tissue proteins, thus leading to weakness in the diaphragm that may allow for~     spontaneous herniation. Comparison of tissue and blood samples from these patients (study~     group) will be made to those from individuals undergoing lower esophageal surgery who have~     not developed a concurrent hernia (i.e. esophageal myotomy for achalasia and laparoscopic~     gastric bypass or laparoscopic adjustable gastric banding for morbid obesity - control~     group).~   "
188361|NCT01099020|"~     The purpose of the research study is to test a measurement tool that will determine the~     radiation dose people receive when they have been accidentally exposed to radiation. This~     test will be done using a small amount of blood and known dose of radiation.~   "
188362|NCT01099007|"~     The overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical~     activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The~     investigators are conducting an intervention for 12 weeks that promotes physical activity~     through support groups, group exercise sessions or through information that is given at the~     baseline appointment. Participants will be randomly assigned to a group.~   "
188366|NCT01098955|"~     This is Part 1 of a 2-part research study. The goal of this part of the study is to plan and~     test an investigational type of counseling called Acceptance and Commitment Therapy, for use~     in patients who have or had head and neck cancer, lung cancer, breast cancer,~     gastrointestinal cancer, or genitourinary cancer.~      This part of the study is also designed to train the study counselors how to perform~     Acceptance and Commitment Therapy.~      In this part of the study, participants will either receive Acceptance and Commitment Therapy~     or the standard type of counseling, called Motivational and Behavioral Counseling.~      This is Part 2 of a 2-part research study. In both parts of the study, participants receive~     either an investigational type of counseling (Acceptance and Commitment Therapy) or a~     standard type of counseling (Motivational and Behavioral Counseling). Part 1 was also~     designed to train the study counselors how to perform Acceptance and Commitment Therapy.~      The goal of Part 2 is to compare Acceptance and Commitment Therapy against Motivational and~     Behavioral Counseling. Researchers want to learn which type of counseling may be more~     effective in helping patients to stop smoking. These types of counseling will be tested in~     patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal~     cancer, or genitourinary cancer.~   "
188367|NCT01098942|"~     Bone loss may occur after bariatric (weight loss) surgery, but standard methods of measuring~     bone density in obese patients are potentially inaccurate. This study uses quantitative~     computed tomography to examine changes in bone mineral density after bariatric surgery. We~     are also studying mechanisms which may explain bone loss after bariatric surgery.~   "
188368|NCT01098929|"~     Congenital diaphragmatic hernia (CDH) occurs when the diaphragm, the muscle that separates~     the chest cavity from the abdominal cavity, does not form properly. When an opening is~     present in the diaphragm, organs that are normally found in the abdomen can move up into the~     chest cavity. The primary objective of this study is to generate information about the~     hereditary basis of congenital diaphragmatic hernia and abnormal lung development. Our~     long-term goal is to identify ways to treat babies in utero with effective but safe drugs to~     speed up lung development before birth.~   "
188369|NCT01098916|"~     Aim of the study is to assess feasibility and safety of a public territorial radiology~     service for home hospitalized frail elderly patients whose health conditions discourage the~     transportation to hospital.~   "
188370|NCT01098903|"~     Sunitinib is an anticancer drug, but like most drugs, the effect varies from person to~     person. This is partly due to a variation in how well each person eradicates the drug from~     the body. This can lead to toxicity if the drug is eliminated slowly. Just as important is~     inadvertent underdosing in people who eliminate the drug quickly which may lead to a reduced~     anti-cancer effect. The investigators group has developed a battery of tests that may measure~     how an individual clears a drug from their body. The investigators intend to apply these~     tests to a group of patients taking sunitinib to see whether any test will help predict the~     level of sunitinib in the body and also the side effects. If a test seems to be promising~     from this study it may be possible to do a simple test on patients before they receive~     sunitinib so the best dose is chosen. The tests involve identifying the genes that are~     involved with drug elimination (CYP3A, ABCB1, ABCG2, OCT1, OATP) as well as directly~     measuring elimination using marker drugs (midazolam clearance and sestamibi liver clearance).~   "
188371|NCT01098890|"~     The proposed study is to evaluate the acceleration the clearance of intraventricular blood~     (IVH) and subarachnoid hemorrhage (SAH) following ruptured intracranial aneurysms, thereby~     ameliorating complications, such as cerebral vasospasm, hydrocephalus and intracranial~     hypertension.~      The primary objectives are:~        1. Estimate the rate and variance of hematoma clearance following aneurysmal SAH, thereby~          facilitating sample size determination for a subsequent larger study;~        2. Assess the feasibility of a randomized controlled trial of intraventricular tissue~          plasminogen activator (TPA) among patients with SAH (enrollment rate, ability to blind~          investigators, protocol compliance);~        3. Confirm the safety of intraventricular TPA.~   "
188372|NCT01098877|"~     The study will evaluate the hypothesis that at doses and plasma concentrations which affect~     pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound~     is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic~     profile is robust and consistent with a once or twice a day therapeutic administration.~   "
188373|NCT01098864|"~     The main objective of this study is to examine the effects of magnetic stimulation on the~     prefrontal cortex. We plan to use low frequency, repeated transcranial magnetic stimulation~     (1 Hz rTMS) to temporarily inhibit activity in the prefrontal cortex and measure the~     resulting effect on two decision-making tasks. The prefrontal cortex is thought to mediate or~     control cognitive functions like decision-making, planning, memory, and inhibit impulsive~     behavior.Previous research has indicated that rTMS over the right dorsal lateral prefrontal~     cortex will lead to preferences for riskier alternatives. Our hypothesis is that rTMS over~     the right DLPFC will lead to greater preference for the riskier alternative and greater~     temporal discounting.~   "
188374|NCT01098851|"~     Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen~     during sleep because of repeated episodes of upper airway obstruction that cause their~     breathing to stop. When these patients have surgery, anesthetic drugs may worsen these~     patterns of lower blood oxygen. This study monitors ten patients at high risk for OSA and ten~     patients at low risk for OSA during surgery. Patterns of lower oxygen saturations should~     arise in the high risk group but not the low risk group.~   "
188375|NCT01098838|"~     The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid~     tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated~     dose of LCL161.~   "
188376|NCT01098825|"~     The purpose of this study is to explore the experiences and perceptions of District VI~     pediatric clinicians on parental vaccine hesitancy and vaccine refusal.~   "
188377|NCT01098812|"~     The aims of this study are to:~        -  Demonstrate a reduction in postoperative cylinder compared to results from the control~          lens~        -  Demonstrate better uncorrected distance visual acuity compared to the control lens~   "
188378|NCT01098799|"~     The investigators are planning to study the serum level of Urotensin II in chronic kidney~     disease patients, kidney transplants, and healthy controls.~   "
188379|NCT01098786|"~     This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese~     subjects.~   "
188385|NCT01098708|"~     Many therapeutic trials in DMD exclude non-ambulatory boys and men. Rate of progression in~     these non-ambulatory patients has been studied but consensus has not been reached for what~     measures are most reliable and reproducible. Furthermore, any treatment trial would be~     expected to demonstrate improved function and improvement in quality of life. Therefore,~     function, strength, and quality of life must be understood and standardized. While the goal~     of this proposal is to standardize clinical outcomes for therapeutic trials, careful~     understanding of the progression of DMD in non ambulatory boys may also lead to better~     medical treatment.~   "
188386|NCT01098695|"~     The investigators are testing the efficacy of a family-based preventive intervention, which~     began when the children were age 2, with children at risk for developing significant conduct~     problems. Families who were originally recruited from Women, Infants and Children (WIC) were~     randomly assigned to a family-centered intervention developed by Dishion and colleagues~     (Dishion & Kavanagh, 2003; Dishion & Stormshak, 2006) referred to as an 'ecological approach~     to family intervention and treatment' (EcoFIT). The current study expands the Early Steps~     intervention into the elementary school years beyond what is currently available for a WIC~     service delivery venue, in which children are no longer eligible for services at age 6.~      The investigators are testing the hypothesis that periodic, tailored, and adaptive~     interventions delivered to caregivers at school entry will (a) reduce the probability of~     elevated risk associated with early-onset problem behavior, including the eventual use of~     drugs and other health-risking behaviors; (b) reduce the likelihood of mental health problems~     such as childhood depression, anxiety, conduct problems and co-morbidity; and (c) promote~     children's development of self-regulation, which underlies school readiness, early school~     literacy academic achievement, and positive peer relations.~   "
188387|NCT01098669|"~     RATIONALE: Collecting information about the impact of lymphedema on symptoms, functional~     status, and quality of life after treatment in patients with head and neck cancer may help~     doctors learn more about the disease and plan the best treatment.~      PURPOSE: This phase I trial is studying the effects of secondary lymphedema on symptoms,~     functional status, and quality of life after treatment in patients with head and neck cancer.~   "
188388|NCT01098656|"~     RATIONALE: Observation is watching a patient's condition but not giving treatment unless~     symptoms appear or change. Lenalidomide may stop the growth of cancer cells by blocking blood~     flow to the cancer. It is not yet known whether observation or lenalidomide is more effective~     in treating patients who are in complete or partial response after receiving previous~     gemcitabine hydrochloride or doxorubicin hydrochloride liposome for cutaneous T-cell lymphoma~     or mycosis fungoides/Sézary syndrome.~      PURPOSE: This randomized phase III trial is studying observation to see how well it works~     compared with lenalidomide in treating patients who are in complete or partial response after~     receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for stage~     IIB, stage III, or stage IV cutaneous T-cell lymphoma or stage IIB, stage III, or stage IV~     mycosis fungoides/Sézary syndrome.~   "
188389|NCT01098643|"~     RATIONALE: Gathering information about patients with solid tumors who have implantable venous~     access devices may help doctors learn more about patient satisfaction.~      PURPOSE: This phase I trial is studying satisfaction with placement of implantable venous~     access devices in patients with solid tumors.~   "
188390|NCT01098630|"~     This clinical trial is studying patient, physician, and nurse factors associated with entry~     onto clinical trials and finishing treatment in patients with primary or recurrent uterine,~     endometrial, or cervical cancer. Determining how patients make decisions about participating~     in a clinical trial may help doctors plan clinical trials in which more patients are willing~     to participate and are satisfied with their decision to participate.~   "
188391|NCT01098617|"~     The aim of the study is to observe the effects of antihemostatic therapy including~     nonsteroidal antiinflammatory, anticoagulant and antiaggregant therapy and other patient and~     procedure related factors on the risk of endoscopic biliary sphincterotomy induced bleeding.~   "
188392|NCT01098604|"~     It has been postulated that use of a larger femoral head could reduce the risk of dislocation~     after total hip arthroplasty, but only limited clinical data have been presented in third~     generation alumina bearings.~      The purpose of this study is to evaluate the effect of femoral head size for total hip~     arthroplasty using third generation alumina bearings on the joint stability and clinical~     results.~      The investigators hypothesized that larger ceramic head group has a similar rate of~     dislocation and clinical results in smaller ceramic head group.~   "
188393|NCT01098591|"~     Numerous human cardiac stem cell studies have been published, including relatively small~     number of patients. Meta-analysis of randomized trials have reported safety and a 3-6%~     increase in global left ventricular performance after intracoronary stem cell therapy in~     patients with acute myocardial infarction. Since most of the studies used different type of~     stem cells, delivery modes, and patient population, the results are heterogenous, therefore~     the comparison of the results is biased regarding generalizable conclusions about the effect~     of treatment. The present comparative meta-analysis is based on individual patient data, and~     gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the~     cardiac stem cell therapy.~   "
188394|NCT01098578|"~     Effectiveness of Floseal for the treatment of posterior epistaxis.~   "
188395|NCT01098565|"~     The purpose of this study is to provide proof-of-concept that the test product can perform as~     intended in an intra-operative setting and the responses to the test product are perceivable~     in a person. The study will also compare results of the test product to the~     commercially-available product.~      Hypothesis: the test product will elicit successful test results in over 90% of test product.~   "
188396|NCT01098552|"~     This research study is being done to collect regular and routine follow-up information~     related to the outcome of treatment for prostate cancer.~      This study is also being done to relate treatment outcome to measurement of substances in the~     blood such as prostate-specific antigen (PSA) and other markers. Also environmental and~     genetic factors that might be responsible for prostate cancer are being investigated.~   "
188466|NCT01097616|"~     This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to~     placebo in improving insomnia as measured by change from baseline in: subjective total sleep~     time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of~     persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may~     participate in an optional 3-month Extension (EXT) Phase.~   "
188397|NCT01098539|"~     This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a~     weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired~     with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately~     controlled on their current regimen of diet and exercise or their antidiabetic therapy of~     metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic~     medications will be recruited into the study.~   "
188398|NCT01098526|"~     GSK1349572 is an integrase inhibitor that is currently in Phase 2 clinical trials for the~     treatment of HIV infection. As GSK1349572 development progresses, it may be dosed with~     non-nucleoside HIV reverse transcriptase inhibitors (NNRTIs) including efavirenz (EFV,~     Sustiva). Efavirenz is a known inducer of CYP3A4. GSK1349572 is primarily metabolized via~     UGT1A1, however it also has a CYP component to its metabolism, thus a drug interaction~     between GSK1349572 and EFV is likely. A previous study showed that another NNRTI, etravirine~     which is also a known inducer of CYP3A and UGT, reduced GSK1349572 exposure significantly.~     GSK1349572 is not an inhibitor or inducer of CYP3A and is not expected to have impact on~     pharmacokinetics (PK) of EFV.~      This study will investigate the dose proportionality between single doses of 50mg and 100mg~     of GSK1349572 and will compare steady-state plasma PK, safety and tolerability of GSK1349572~     50 mg every 24h (q24h) with and without efavirenz 600 mg q24h. Approximately 12 subjects will~     receive a single dose of GSK1349572 100 mg (Treatment A) in Period 1 followed by a washout of~     greater than or equal to 6 days. In Period 2 subjects will receive GSK1349572 50mg q24h for 5~     days (Treatment B). Subjects will then be administered GSK1349572 50mg q24h in the morning in~     combination with EFV 600 mg q24h (Treatment C) in the evening for 14 days in Period 3. There~     will be no washout between Periods 2 and 3. Safety evaluations and serial PK samples for~     GSK1349572 will be collected during each treatment period. A follow-up visit will occur 7-14~     days after the last dose of study drug.~      This study will be conducted at one center in the US, with healthy adult male and female~     subjects.~   "
188399|NCT01098513|"~     This is a single-center, randomized, two part, open-label, crossover study in healthy adult~     subjects. Part A will evaluate the relative bioavailability of two new tablet formulations~     compared to the current tablet formulation of GSK1349572 at 50 mg administered as single~     doses each comprising of two 25 mg tablets. Pharmacokinetic samples from Part A will be~     analyzed and, if at least one of the new formulations meets appropriate criteria and is~     selected, Part B will be a single-sequence design conducted to evaluate food effect of the~     selected new tablet formulation at one dose level. A subset of subjects enrolled in Part A~     will continue in Part B. Safety evaluations and serial PK samples will be collected during~     each treatment period. A follow-up visit will occur 7-28 days after the last dose of study~     drug.~   "
188400|NCT01098500|"~     A retrospective cohort study using the LabRx medical claims database will be performed to~     address these objectives. The primary objective of this project is to examine the background~     rates of liver function test (LFT) abnormalities in cancer patients treated with tyrosine~     kinase inhibitors (TKIs).~   "
188401|NCT01098487|"~     A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone~     marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic~     purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The~     study will also describe the long-term safety and tolerability of oral eltrombopag treatment~     in subjects with chronic ITP.~   "
188402|NCT01098474|"~     This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals'~     candidate tuberculosis vaccine (692342) when administered concomitantly with or after the~     Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and~     including 2 and 7 months, living in a tuberculosis endemic region.~   "
188403|NCT01098461|"~     This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose~     ranging study evaluating the dose response, efficacy and safety of subcutaneously injected~     GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.~   "
188404|NCT01098448|"~     The purpose of this study is to test combined effects of scaling and root planing with~     periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local~     tetracycline on pocket depth reduction and attachment level gain in patients with chronic~     periodontitis.~   "
188405|NCT01098435|"~     The purpose of this study is to evaluate the safety of daily doses of RDC-0313 (ALKS 33)~     compared with placebo in adults with binge-eating disorder (BED). An additional objective is~     to explore the efficacy of RDC-0313 treatment in comparison with placebo in adults with~     binge-eating disorder.~   "
188406|NCT01098422|"~     The purpose of this study is to determine the effectiveness of radioactive microsphere~     infusion as a treatment for liver metastases from colon or rectal cancer. The investigators~     hypothesis is that the administration of microspheres between first and second line~     chemotherapy will increase progression-free survival time by about 2.5 months and may also~     improve tumor response rates to subsequent second line chemotherapy.~   "
188407|NCT01098409|"~     The purpose of this study is to determine whether sodium nitrite administration 24 hours~     prior to or during coronary artery bypass surgery protects the heart better from lack of~     blood flow which occurs as part of this type of operation. The study will also determine what~     the mechanisms of this cardioprotection are.~   "
188408|NCT01098396|"~     Gait disturbances are very common and are a major cause for losing of independency in~     patients with advanced Parkinson's Disease (PD). The medical treatment of gait disturbances~     in advanced PD is very difficult and in many cases the classical dopaminergic treatment has~     no clinical benefit or even can worsen the instability and increase falls. Rasagiline, a new~     MAO-B inhibitor who has recently been approved all over the world for the treatment of early~     and late stages PD has been suggested to have a special effect of gait in patients with~     advanced PD (LARGO sub-study).~   "
188409|NCT01098383|"~     We propose a study which will combine multiple modalities in evaluating the treatment~     response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE)~     inhibitors and choline supplements. The primary objective of the study is to examine the~     efficacy of this treatment in improving core autistic symptoms. The Secondary objective of~     the study is to evaluate the safety and tolerability of the treatment protocol in ASD~     children. Exploratory objectives include evaluation of the influence of the treatment on~     linguistic performance, comorbid behaviors, adaptive functioning and executive functions.~   "
188410|NCT01098357|"~     This is an open-label, active-control, multicentre, parallel group, randomised and~     dose-finding efficacy and safety study.~      Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days~     for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks~     for the treatment of neuropathic diabetic foot ulcer.~      Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days~     for up to 20 weeks.~   "
188411|NCT01098344|"~     RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving MK0752 together with gemcitabine hydrochloride may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of giving MK0752~     together with gemcitabine hydrochloride and to see how well it works in treating patients~     with stage III or IV pancreatic cancer that cannot be removed by surgery.~   "
188412|NCT01098331|"~     RATIONALE: Receiving standard information and watching a video or DVD at home that describes~     treatment options and treatment outcomes may help patients decide to receive treatment in a~     clinical trial.~      PURPOSE: This randomized clinical trial is studying implant radiation therapy to see how well~     it works compared with surgery in treating patients with prostate cancer.~   "
188413|NCT01098318|"~     Prior research has shown that Rhodiola rosea may be an effective, short-term, anti-depressant~     therapy. This study will examine the anti-depressant effect of Rhodiola rosea vs. a~     conventional, anti-depressant drug in the treatment of major depression.~   "
188414|NCT01098305|"~     This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco~     users with cessation efforts.~   "
188415|NCT01098292|"~     The Control Study for the Multidisciplinary Approach to the Study of Chronic Pelvic Pain~     (MAPP) Research Network has been established to focus on a broader approach to the study of~     Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic~     Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken.~      Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific~     conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome~     (CFS)) are being recruited for the Trans-MAPP Control Study. These participants will act as a~     reference/control group for the Trans-MAPP Epidemiology & Phenotyping (EP) Study.~      As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often~     not helpful. The goal of this study is to better understand how pain is felt in people with~     IC or CP. The MAPP Control Study is an observational study that will enroll participants from~     6 Discovery Sites and 3 Satellite Sites across the U.S. The investigators will ask questions~     and gather information about the health and life of the participants for research purposes.~     The investigators hope that this study will lead to improvement in the treatment of IC and~     CP.~   "
188416|NCT01098279|"~     The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network~     has been established to focus on a broader approach to the study of Interstitial Cystitis~     (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic~     Pelvic Pain Syndrome (CPPS) in men, than previously undertaken. Participants with some form~     or symptoms of IC or CP are being asked to join the Trans-MAPP Epidemiology and Phenotyping~     (EP) Study.~      As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often~     not helpful. The goal of this study is to better understand how pain is felt in people with~     IC or CP. The MAPP EP Study is an observational study that will enroll approximately 360~     participants from 6 Discovery Sites and 3 Satellite Sites across the U.S. We will ask~     questions and gather information about the health and life of the participants for research~     purposes. No study treatment or interventions will be given to participants in MAPP. We hope~     that this study will lead to improvement in the treatment of IC and CP.~   "
188417|NCT01098266|"~     The main objective of the trial is to document the efficacy of NGR-hTNF administered at low~     dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a~     pemetrexed-based chemotherapy regimen.~   "
188418|NCT01098253|"~     The goal of this proposal is to integrate depression services into improving adherence for~     oral hypoglycemic agents so that a single program can assist patients. The investigators~     hypothesized that patients in the intervention would demonstrate improved adherence to~     patients' oral hypoglycemic agents and antidepressants as well as improved clinical outcomes.~   "
188419|NCT01098240|"~     The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared~     to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major~     Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2)~     Evaluate the safety and tolerability of CP 601,927 in patients with MDD on ADT.~   "
188420|NCT01098227|"~     The fraction of exhaled nitric oxide (FeNO) in expired air is a reliable measure of airway~     inflammation and has been used as a marker in asthma and other respiratory illnesses such as~     primary ciliary dyskinesia, bronchopulmonary dysplasia (BPD), liver cirrhosis, chronic~     obstructive pulmonary disease (COPD), cystic fibrosis (CF). Although, some exquisite bench~     research experiments have demonstrated stimulation of nitric oxide production in respiratory~     epithelial cells infected with RSV, there is a paucity of clinical data regarding levels of~     feNO in viral respiratory illness and specifically RSV.~      The investigators conducted a pilot study from the fall of 2007 until October of 2009,~     looking at FeNO levels in RSV infected patients and compared it to non-RSV viral infections.~     The investigators recruited a total of 28 RSV positive and 1 RSV negative subjects, as well~     as 4 control subjects. The investigators found FeNO values not statistically significant~     between the study group (the two-tailed p=0.09, considered not quite significant), but there~     was a trend of higher FeNO values in the non-RSV group when compared to the RSV group. A~     larger sample may detect a statistically significance between these 2 groups.~      Objectives:~      i. To determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized~     pediatric patients with viral lower respiratory illness when compared with normal subjects~     without respiratory symptoms.~      ii. To determine if there is a difference in feNO level between RSV and non-RSV infection in~     hospitalized pediatric patients with viral lower respiratory illness.~      Method of feNO measurement utilized the offline options for preschool children & infants~     appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society~     & the European Respiratory Society when discussing tidal breathing techniques with~     uncontrolled flow rate.~      The investigators plan that our sample sizes for the RSV+ and control groups will be, by~     design, three times as large as the RSV- group. In order to achieve 80% power, the~     investigators will then require 45 control and 45 RSV+ patients, and 15 RSV- patients~   "
188421|NCT01098214|"~     To provide rigorous, detailed normative data for diagnostics and comparative studies, to~     determine relationships between cytokine levels (and other biomarkers) and clinical data, and~     gain further insight into the pro-/anti-inflammatory cytokine profile of normal midtrimester~     amniotic fluid.~   "
188422|NCT01098201|"~     This open-label pilot study will select subjects who are inadequate responders to~     methotrexate. These subjects will receive certolizumab subcutaneously on a monthly basis for~     six months. The study is attempting to determine the following:~        1. Is lymphatic flow altered in the extremities of RA patients with an inflamed knee?~        2. Is resolution of synovitis associated with a restoration of lymphatic flow and lymph~          node volume following therapy with certolizumab?~        3. Can Doppler ultrasound be used to detect and follow alterations of lymph node size?~   "
188423|NCT01098188|"~     This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of~     the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell~     chronic lymphocytic leukemia who have received at least one prior fludarabine-containing~     regimen.~   "
188424|NCT01098175|"~     Given the observations in animal models and the available data in the human our hypothesis is~     that peritoneal cavity conditioning (carbon dioxide with 4% of oxygen and 10% of N2O, 100%~     humidification at 32°C,) during open surgery, will result in an important decrease in~     postoperative peritoneal inflammation, postoperative pain, and will restore bowel transit~     faster.~   "
188425|NCT01098162|"~     The purpose of this study is to systematically and prospectively collect data from patients~     with partial-onset seizures in routine clinical practice setting receiving adjunctive~     Vimpat®. The observed population will be only patients with one baseline antiepileptic drug.~     Seizure control and tolerability data will be evaluated.~   "
188426|NCT01098149|"~     Diabetic nephropathy is becoming the most common primary renal disease in end stage renal~     disease patients. The prevalence of diabetic patients in dialysis reaches even the 30% of the~     dialysis population (USRDS) with an incidence rate, in some countries, up to 40%. The 5 years~     surviving time of diabetic patients in dialysis is about the 20% and, compared to the~     hypertension and glomerulonephritis complications, still remains the worst. Diabetes is often~     associated to several comorbid factors such as hypertension, autonomic neuropathy,~     vasculopathy, metabolic disorders (ketoacidosis, poor glycaemic control), and electrolyte~     disorders. So, the diabetic patient is fragile, with a rather poor tolerance to dialysis,~     lack of achievement of dry body weight and inadequate dialysis. In order to gain a more~     detailed insight into a possible better tolerance to dialysis, arising from the elimination~     of acetate in dialysate bath (Acetate Free Biofiltration) and from the use of an automatic~     system to control the blood volume (Blood Volume Control),the investigators would like to~     investigate the cardiovascular stability and the frequency of intradialytic symptoms in a~     prospective, randomized, cross-over study.~   "
188427|NCT01098136|"~     The objectives in this study are~        1. to explore the incidence and cumulative prevalence of pelvic girdle pain (PGP) and its~          subgroups in a prospective longitudinal study during pregnancy, from 18 weeks until 6~          weeks after delivery.~        2. to examine the outcome of chiropractic management for a dominating one-sided PGP~          subgroup of pregnant women in a single-blinded controlled study, and to use efficacy~          measures that include pain, functional impairment, and sick-leave frequency.~        3. to investigate possible predictors for treatment outcome in one-sided PGP in pregnant~          women.~   "
188428|NCT01098123|"~     The aim of this study was to assess the relevance of NRI or athletes' NRI (ANRI) utilization~     to detect nutrition-related risks of failure in competition in the particular population of~     rowers.~      In the morning, 60 to 90 minutes before the first race of a national level multi-races~     competition (three races for each subjects), body weight were measured and blood samples were~     collected with subjects at rest and in post-absorptive condition (last meal at least 2.5~     hours before blood collection). Body weight was also recorded in the same conditions six~     weeks before the competition to calculate weight state (actual weight /usual weight ´ 100)~     and subjects were asked to identify the date of diet beginning. Body weight was measured~     using a floor scale (Mettler-Toledo floor scale, France), body mass index (BMI) was~     calculated from the ratio of weight (in kg) by height squared (in meters) and training volume~     (total duration of training in a week) was determined after discussion with athletes and~     coaches.~   "
188429|NCT01098110|"~     A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the~     efficacy and safety of asenapine compared with placebo in participants with an acute~     exacerbation of schizophrenia.~   "
188430|NCT01098097|"~     To study retreatment in patients who failed prior treatment with interferon alpha (pegylated~     or non-pegylated) with or without ribavirin in a real-life setting in an~     observational/noninterventional study.~   "
188431|NCT01098084|"~     The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with~     chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated~     or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or~     intensive chemotherapy given more than 3 months before inclusion.~   "
188432|NCT01098071|"~     To document the short term & long term effect of treatment with Nasonex (mometasone furoate~     nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the~     posterior choanae).~   "
188433|NCT01098058|"~     The purpose of the study is to compare the effectiveness of cognitive-behavioural therapy~     (CBT) plus treatment as usual with treatment as usual only in treating adults with attention~     deficit hyperactivity disorder (ADHD).~   "
188434|NCT01098045|"~     The specific aims of this study are to determine whether HIV-infected patients with~     significant fat redistribution and ectopic fat accumulation have increased brown adipose~     tissue using 18F-FDG Positron Emission Tomography techniques.~      Recent studies suggest down regulation of Dicer, a major component of miRNA has an important~     role in the differentiation and function of brown and white adipose tissue and may contribute~     to lipodystrophy. Therefore we will expand on recent research in this area by recruiting~     HIV-infected men with lipodystrophy. We will perform subcutaneous fat biopsies of the~     dorsocervical and abdominal fat in a subset of HIV-infected and non-HIV-infected men in order~     to explore further the question of down regulation of Dicer and its implication on metabolic~     abnormalities in this population.~   "
188467|NCT01097603|"~     To validate accuracy of the readings of noninvasive blood pressure (NIBP) module with~     sphygmomanometer as per the requirements of AAMI SP10:2002. This study is for adult and~     pediatric population.~   "
188468|NCT01097590|"~     The purpose of this study is to determine whether a treatment of a novel leukapheresis column~     is safe and effective in patients with moderate to severe ulcerative colitis.~   "
188435|NCT01098032|"~     The purpose of the present study is to assess the role of the RenalGuard System as compared~     to the optimal strategy (sodium bicarbonate infusion plus N-acetylcysteine (NAC)) in high and~     very-high risk patients to prevent contrast-induced acute kidney injury contrast induced~     acute kidney injury (CI-AKI).~      Consecutive patients with chronic kidney disease, referred to our institutions for coronary~     and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of~     sodium bicarbonate plus NAC (Systemic alone therapy group; n > 133) and 2) RenalGuard System~     treatment (RenalGuard group; n > 133). All enrolled patients must have an estimated~     glomerular filtration rate <30 ml/min/1.73 m2 and/or a contrast nephropathy risk score ≥11).~     In all cases iodixanol (an iso-osmolar, non ionic contrast agent) will be administered. The~     primary end point is an increase of >=0.3 mg/dL in the creatinine concentration 48 hours~     after the procedure.~      This study will give important answers on how to prevent CI-AKI in high and very-high risk~     patients undergoing contrast media exposure.~   "
188436|NCT01098019|"~     Patients will be randomized (1:1) to receive either injections of Xeomin in 0.9% NaCl or NaCl~     alone. Xeomin will be reconstituted with 2 mL of NaCl 0.9 which will give a final~     concentration of 5 U of botulinum toxin A per 0.1 mL. The area affected will be injected with~     0.1 mL at each 1-2 cm2 for a maximum total dose of 200 units. Patients will be evaluated at~     Weeks 8, 12, 18 and 24. An unblinded pharmacist or designee will prepare placebo and Xeomin~     injections. Patients will be unblinded at the end of the week 12 visit. After unblinding (at~     week 12) patients who were randomized to placebo will receive Xeomin while patients initially~     randomized to Xeomin will not be injected. All patients will be seen for follow-up visits at~     Weeks 18 and 24. Efficacy in reducing pruritus will be measured with a 10 cm visual analogue~     score. This will be performed at Day 0, Week 8, Week 12, Week 18 and Week 24. Efficacy will~     also be measured by measuring the area of the hyperpigmented zone on the back. Safety will be~     evaluated with adverse events.~   "
188437|NCT01098006|"~     The purpose of this study is to develop and characterize immunological assays on blood~     samples.~   "
188438|NCT01097993|"~     The purpose of this study is to evaluate the effect of a commercially available fermented~     dairy product containing probiotics (4 weeks, twice a day) on abdominal distension in IBS~     patients with constipation (IBS-C).~   "
188439|NCT01097980|"~     The aim of this study is to investigate the efficacy of trazodone in the treatment of~     selective serotonin reuptake inhibitor(s) associated sexual dysfunction. The secondary~     domains assessed were the relationship between 5-HT2A polymorphism and treatment efficacy.~   "
188440|NCT01097967|"~     The study aims to observe the short term effect (3-month) of sleep disordered breathing (SDB)~     on cardiovascular parameters, heart rate variability, endothelial function and surrogate~     markers of atherosclerosis after acute cerebrovascular events (ACE). The long-term effect~     (6-24-month) of Continuous Positive Airway Pressure (CPAP) on clinical vascular outcome,~     cardiovascular parameters, evolution of surrogate of atherosclerosis heart rate variability~     and endothelial function after ACE is observed over 24 months. A preventive effect of CPAP~     therapy on cerebro-vascular events in patients with moderate-severe obstructive SDB without~     sleepiness after ictus or transient ischaemic attack will be evaluated.~   "
188441|NCT01097954|"~     Exercise induced bronchospasm (EIB), also known as exercise induced asthma (EIA) is a~     transient obstruction to airflow triggered by exertion.~      It is now a well known identity, center of discussion in recent years, particularly in the~     athletes' world. It is more common in asthmatic individuals (regardless of severity of~     disease), but it is also seen in otherwise healthy subjects, leading to the general consensus~     that the pathophysiology is different than asthma.~      The concentration of exhaled nitric oxide (FeNO) in various airway & respiratory disorders,~     particularly asthma, has been deeply studied. Its use for noninvasive monitoring of asthma~     control (reflecting airway eosinophilic inflammation) is being closely examined and put into~     clinical practice. FeNO is significantly elevated in asthma. Elevated FeNO levels have also~     been noted in patients hospitalized with a COPD exacerbation, acidosis, rhinitis,~     bronchiectasis, active pulmonary sarcoidosis, active fibrosing alveolitis, and acute lung~     allograft rejection. Decreased FeNO levels have been seen in patients with primary ciliary~     dyskinesia, cystic fibrosis, PiZZ phenotype-related alpha-1 antitrypsin deficiency, and~     pulmonary hypertension~      Two studies have addressed the variations on FeNO after EIB and they had contradictory~     results. Scollo et al. found no change in FeNO in either healthy or asthmatic children after~     a 6-min of vigorous exertion in an exercise laboratory when they studied 24 asthmatic and 18~     control children. Terada et al. reported, for 39 subjects, a decrease in FeNO in subjects~     with EIB and an increase in healthy controls.~      It is well accepted that the pathophysiology of exercise induced bronchospasm it is not~     similar to that of asthma. Certainly the inflammation in the airway does not appear to be~     eosinophilic. Understanding the disease mechanism is a key factor to adequately manage it.~      This will be a prospective study measuring online exhaled nitric oxide involving children 8~     to 21 years old. The study group will include any children coming for a pulmonary exercise~     test in the exercise laboratory located in the Pediatric Pulmonary Division office.~      The study will be conducted from the fall of 2009 until the spring of 2011. The change in the~     FeNO measurement will be correlated with the change in % predicted FEV1. We will consider~     significant a decrease in FEV1 post exercise of 15% and/or decrease on FEF25-75 of 20% that~     will persist until 15 minutes after completing exercise.~      We will also record any symptoms reported by the subject during or after the test.~      An exercise test is a standard of care when suspecting exercise-induced asthma. The subjects~     and their parents coming for exercise test will be offered the opportunity to participate in~     the study.~      The subject will come for the exercise test and will perform spirometry and FeNO measurement~     prior to start the test. According to our exercise laboratory protocol 1 minute of warm up at~     a low speed, followed by 6 minutes of high speed (enough to increase heart rate to 90%~     predicted or more) and 3 minutes of cool down at a low speed will be performed.~      Then spirometry will be repeated at 3, 5, 10 and 15 minutes and FeNO measurement will be~     taken at 5, 10 and 15 minutes.~      We will analyze the data to find if there is any significant change in FeNO measurements~     after exercise.~   "
188442|NCT01097941|"~     A total of 51 children between the ages of 4 and 9 will be randomized to receive a two dose~     schedule of either licensed live attenuated A/California/07/09 influenza vaccine (LAIV) or~     licensed inactivated A/California/07/09 influenza vaccine (IIV) or IIV followed by LAIV~     separated by 28 days. Children with prior vaccination or natural infection with novel H1N1~     influenza will be excluded. Randomization will be stratified by pre-existing HAI titers to~     the previous winter's seasonal H1N1 A/Brisbane/57/07 reference virus.~   "
188443|NCT01097928|"~     A prospective observational study to evaluate the safety and effectiveness data of~     catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for~     treatment of acute pulmonary embolism (PE)~   "
188444|NCT01097915|"~     The investigators evaluate the possible association of PROP taste with gustin gene~     polymorphism rs2274333 (A/G), salivary zinc ion concentration and BMI. In addition, it has~     also been evaluated PROP taste sensitivity by recording monophasic potentials from the~     tongue.~   "
188445|NCT01097902|"~     The experimental pain model studied in this proposal show characteristics of an inflamed~     wound with a pro-inflammatory response. This study will help discover candidate genetic~     and/or proteomic pain biomarkers that could provide objective and mechanism based tests to~     diagnose, monitor or quantify pain. We also hope to determine the measurable effects of a~     known non-steroidal anti-inflammatory drug (NSAID) on biomarkers of pain and inflammation.~   "
188446|NCT01097889|"~     Supplementary feeding programs for children with moderate acute malnutrition have been~     implemented in developing countries using treatment foods with minimal or no evidence of~     their effectiveness. Fortified peanut paste is a popular new treatment food for children with~     severe and moderate malnutrition.~      Objectives: To investigate the relative effectiveness of two non-identical therapeutic foods~     in children with moderate malnutrition by comparing differences in performance indicators~     (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each~     group.~      This proposed research project will evaluate the relative effectiveness of two non-identical~     treatment foods for the treatment of moderate acute malnutrition in children~   "
188447|NCT01097876|"~     The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before~     and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels~     of both PF-04447943 and donepezil.~   "
188448|NCT01097863|"~     The purpose of this study is to validate the improvements to the inversion indicator.~   "
188449|NCT01097850|"~     The purpose of this study is to determine whether henna paste is effective in the treatment~     of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal~     doxorubicin.~   "
188464|NCT01097642|"~     Ixabepilone and capecitabine combination has demonstrated to be an active regimen in patients~     with metastatic breast cancer after failing other treatments. Cetuximab is active against~     tumors expressing epidermal growth factor receptor w/demonstrated activity in head & neck and~     colorectal tumors and may be effective in some breast cancers known to express EGFR. Study~     seeks to evaluate Ixabepilone alone or in combination with cetuximab as a an antitumor~     therapy w/randomization stratified by stage (T1N1-3M0 or T2-4 N0-3M0).~   "
188450|NCT01097837|"~     Despite the importance of birth control to women of reproductive age, there has been little~     formal investigation of the safety and effectiveness of birth control methods in women with~     epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have~     developed a website that offers a survey to help us gain more knowledge and some educational~     material that will be updated regularly to provide the latest information. The ultimate goal~     is to develop guidelines for the selection of safe and effective birth control methods and to~     make sure that the best forms of birth control become available to women with epilepsy in all~     communities of our society.~      Go to www.epilepsybirthcontrolregistry.com take our survey and then catch up on the latest~     information about birth control for women with epilepsy.~   "
188451|NCT01097811|"~     Comparison between the efficacy of two different antibiotics in patients with overt hepatic~     encephalopathy. The study is randomized, controlled and double-blinded.~   "
188452|NCT01097798|"~     Multicenter, randomized, double-blind trial, to evaluate the efficacy and safety Aliviador~     compared to Gelol in the relief of signs and symptoms in patients with contusions, sprains,~     trauma and muscle injury start with less than 24 hours or patients of myalgia, myofascial~     pain and tendinitis.~   "
188453|NCT01097785|"~     Heart failure (HF) is a leading cause of morbidity and mortality in the United States with~     the incidence and prevalence of the disease on a continual rise. An overactive sympathetic~     nervous system has become a hallmark characteristic of HF. Although sympathetic activation is~     initially beneficial to maintain cardiac output, blood pressure and perfusion to vital~     organs, over the long term it becomes deleterious contributing to the worsening of HF and~     sudden cardiac death. Indeed, recent findings in HF patients suggest that the sympathetic~     overactivity is not just a marker of poor prognosis but it plays a causative role in the~     development of the disease. Thus, the sympathetic nervous system constitutes a putative drug~     target in the treatment of HF. However, despite aggressive medical management, including~     conventional anti-adrenergic strategies, sympathetic nerve activity (SNA) has been shown to~     remain abnormally high in HF patients and improvements in survival have been limited. Thus,~     other treatment strategies that include reducing SNA and its deleterious consequences are~     warranted. Recent findings from clinical trials indicate that 3-hydroxy-3-methyl-glutaryl~     coenzyme A reductase inhibitors (statins) improve survival irrespective of cholesterol~     lowering bringing the pleiotropic (i.e., cholesterol independent) effects of statins to the~     forefront. An important pleiotropic effect recently reported in experimental HF, that has yet~     to be directly tested in human HF, is the ability of statins to reduce resting sympathetic~     outflow. Several studies in pacing-induced HF rabbits have demonstrated that statins~     normalize the excessive sympathetic activation in the HF state. Thus, the goal of this~     project is to determine whether these findings in experimental HF can be translated to the~     clinical setting of human HF. Our central hypothesis is that statins reduce sympathetic~     overactivity in HF patients. To test this hypothesis we will directly measure muscle SNA and~     perform a randomized crossover placebo control study. Subjects will come to the research~     laboratory before and after the administration of Simvastatin at a standard therapeutic~     dosage of 40 mg. per day or placebo for 1 month~   "
188454|NCT01097772|"~     A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal~     Stent Graft System~   "
188455|NCT01097759|"~     This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled~     hemorrhoidopexy for prolapsed hemorrhoids.~   "
188456|NCT01097746|"~     The goal of this clinical research study is to learn if therapy with bevacizumab,~     carboplatin, and weekly doses of paclitaxel is safe and can be tolerated in patients with~     newly diagnosed epithelial ovarian, primary peritoneal, or fallopian tube cancer. Researchers~     will also study if and how well this study therapy may help to control the disease.~   "
188457|NCT01097733|"~     Cardiac Resynchronization Therapy (CRT) is a widely accepted treatment that has led to~     improved clinical outcomes for patients with refractory congestive heart failure (CHF),~     systolic dysfunction, and wide QRS duration. However, it requires implantation of an~     expensive device ($30,000) and about 1/3 of patients do not have clinical improvement.~     Inadequate amounts of LV dyssynchrony or suboptimal lead placement may limit clinical~     response. Dual-Source computed tomography (DSCT) allows for subtle detection during~     myocardial contraction for assessing LV dyssynchrony, and can also assess coronary venous~     anatomy and scar burden. Thus DSCT may be the ideal noninvasive modality to predict response~     to CRT.~   "
188458|NCT01097720|"~     This study is investigating the neurodevelopmental effects of prenatal exposure to~     lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The~     hypotheses to be tested include:~        1. Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with~          developmental delay with or without signs of autism.~        2. Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased~          rate of occurrence of major malformations.~        3. The child with major malformations is more likely to have developmental delay with or~          without signs of autism than the child who does not have major malformations.~        4. The occurrence of adaptive behavior outcomes will show a dose-response relationship with~          the dose of medication taken by the mother in the first trimester.~      The study population includes children 36-83 months of age who were exposed throughout~     gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.~   "
188459|NCT01097707|"~     The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic~     Hyperplasia (BPH)~   "
188460|NCT01097694|"~     The purpose of this study is to see whether a new investigational drug (Imatinib) may help~     improve asthma in people whose symptoms are not well controlled with high dose inhaled~     corticosteroid treatment.~   "
188461|NCT01097681|"~     The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2~     diabetes mellitus patients with normal renal function and those with mild or moderate renal~     impairment.~   "
188462|NCT01097668|"~     Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with~     relapsing forms of multiple sclerosis. This will be an open label upward dose titration~     involving injections on 9 occasions, each two weeks apart. After dosing is complete there~     will be a 22 week follow up period. Blood samples will be drawn throughout the study to~     monitor safety and the body's response to the injections and MRI scans will be performed on~     several occasions to follow the course of the multiple sclerosis during the trial.~   "
188463|NCT01097655|"~     The objective of this study is to observe and collect data on the usage, dosing,~     tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human~     immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the~     impact on tolerability of changing therapy to Kaletra tablets from other regimens.~   "
188465|NCT01097629|"~     This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to~     placebo in improving insomnia as measured by change from baseline in: subjective total sleep~     time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of~     persistent sleep.~   "
188469|NCT01097577|"~     Purpose: To compare the efficacy of pregabalin to placebo for postoperative pain control~     after photorefractive keratectomy.~      Patients: Study subjects will be taken from a standard group of typical candidates for PRK~     surgery including active duty and DoD beneficiaries. Prior to being approached for the study,~     all patients will have had a previous desire for surgery and had a pre-operative evaluation~     indicating healthy ocular status.~      Methods: Patients scheduled for PRK surgery will be briefed on the purpose of the study and~     invited to participate at the preoperative appointment. After the consent process, patients~     will be randomized in a 1:1 fashion to receive either oral pregabalin 75mg BID or placebo for~     pain control, in addition to the standard care treatment of as needed Percocet and tetracaine~     ophthalmic drops. Subjects will be evaluated daily for 4 days post-operatively for subjective~     pain assessment, adverse drug events and compliance, use of concomitant medications as well~     as monitoring of healing time. Quality of life will be measured at baseline and post-op day 2~     when the peak of pain is anticipated. Analysis will be performed to detect an approximate 10%~     improvement in pain scores. Secondary outcomes will include measuring healing time, quality~     of life and use of rescue medications.~   "
188470|NCT01097564|"~     This prospective multicenter cohort study aims to define the clinical, radiological and~     mutational spectrum of the disease related to COL4A1 gene.~   "
188471|NCT01097551|"~     The aim of the study is to progress in the understanding of the early retinal vascular and~     neural abnormalities in patients with diabetes, using a new device, the Dynamic Vessel~     Analyzer. The Dynamic Vessel Analyzer allows to measure the diameter of the retinal vessels~     and to assess how it varies in presence of various stimuli. Then, we will be able to assess~     if a vascular and/or a neural dysfunction is present early in patient with diabetes.~   "
188472|NCT01097538|"~     This project will evaluate a new therapy for patients with a severe form of MS known as~     progressive MS. These patients are severely limited in their ability to walk and function in~     everyday life. The exercise therapy we are proposing is a recumbent cross trainer which~     allows patients to be seated and move their arms and legs at the same time against resistive~     foot pedals and arm levers. The recumbent cross trainer is safe and easy to use for people~     with disabilities and is more cost-effective compared with other rehabilitation equipment.~     Before the recumbent trainer can become part of mainstream MS therapy, it is important to~     determine if it is as effective as other exercise therapies in improving functional~     performance and quality of life. In this study we will compare the effects of the recumbent~     cross training with supported treadmill walking on functional and psychological outcomes.~     Further, since this is a new therapy for progressive MS patients, we also want to determine~     if it is safe and enjoyable to use.~      We hypothesize that recumbent stepper training will be safe and well-tolerated by progressive~     MS patients. Both training interventions will be beneficial in improving walking function and~     psychosocial outcomes. Recumbent stepper straining will likely have greater effects on upper~     extremity function, while supported treadmill walking will have greater effects on lower~     extremity function.~   "
188473|NCT01097525|"~     To determine the effect of two types of wavefront modalities (WFG vs. WFO) and two types of~     refractive surgery (PRK vs. LASIK) on visual and military task performance after laser~     refractive surgery.~   "
188474|NCT01097512|"~     In clinical practice and research, combination of anticancer agents is often used to improve~     efficacy of treatment. In vitro and in vivo experiments have shown additive-synergistic~     anti-tumour effects of AS703569 treatment when combined with gemcitabine. Specifically,~     additive-synergistic anti-tumour effects were noticed when the two agents were given~     sequentially and not concomitantly i.e. AS703569 given the day before or the day after~     gemcitabine. This trial was designed to investigate in parallel two regimens testing~     sequential administration of AS703569 either the day after gemcitabine infusion, (Regimen 1)~     or the day before (Regimen 2).~   "
188475|NCT01097499|"~     Study hypothesis: Low level laser (LED) will reduce initial bone resorption and improve~     primary stability of dental implant. It will also reduces post operative pain compared to~     patient without treatment~      Implant osseointegration depends on many factors including biocompatibility of implant~     materials, design, surface, surgical access, patient conditions, biomechanical status, and~     lack of primary stability.~      Several in vivo and in vitro studies showed the healing effect of low level laser therapy~     (LLLT) on bone by decreasing the initial bone resorption postoperatively and increasing the~     primary stability of the implant. It has also shown to have an analgesic effect intraorally~     when used post intraoral surgical procedures. The exact mechanism is unclear despite the fact~     that many hypothesis has been proposed.~      In our study, our goal is to present, in a randomized standardized clinical trial, the effect~     of LLLT on post operative implant stability assessed by resonance frequency analysis (RFA).~     We will assess the subjective measures of postoperative pain using visual analog scale (VAS).~   "
188476|NCT01097486|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in~     subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical~     vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level~     anterior cervical discectomy and fusion with anterior cervical plate fixation.~   "
188477|NCT01097473|"~     This controlled study is undertaken to investigate the effects of a long term outpatient~     training program on physical fitness and quality of life in elderly asthmatics.~   "
188478|NCT01097460|"~     This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.~   "
188479|NCT01097447|"~     To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen~     (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by~     inducing additional cross-links within or between collagen fibers using UVA light and the~     photo- mediator riboflavin. The purpose of this study is to generate data for presentation at~     medical meetings and for peer-review publication~   "
188480|NCT01097434|"~     The objective of the study is to assess the superiority of the biodegradable polymer based~     limus-eluting stent (Nobori®) compared with the permanent polymer based everolimus-eluting~     stent (XIENCE V®) regarding absolute percentage of uncovered stent strut segments.~   "
188737|NCT01094067|"~     Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate~     that a single infusion of tezosentan has minimal effect on blood pressure in patients with~     pulmonary arterial hypertension, treated with endothelin receptor antagonists,~     phosphodiesterase-5 inhibitors or a combination of both.~   "
188481|NCT01097421|"~     This is an open-label, prospective post marketing surveillance study to be performed in~     Sweden. Only data of patients idiopathic PD should be documented, in whom the treating~     physician plans to initiate a pharmacotherapy with PPX ER independent of this observational~     study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale,~     CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure~     high validity of the observational data. As the degree medication adherence of patients is~     routinely evaluated by their physicians, as is patient preference and possible symptom~     improvement after initiation of a new therapy, the patient questionnaires will be used to~     standardise medical routine care and to ensure validity of observational data.~   "
188482|NCT01097408|"~     This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.~   "
188483|NCT01097395|"~     The purpose of this study is to determine if concentration-controlled ribavirin dosing can~     achieve a targeted level of plasma exposures and if it appears safe and effective compared~     with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants~     with genotype 1 disease will be randomized to receive concentration-guided or standard~     weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided~     through the study.~   "
188484|NCT01097382|"~     Primary Objective:~      To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration~      Secondary Objective:~      To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration~   "
188485|NCT01097369|"~     Primary Objective:~      To determine the incidence, titer and type of anti-rasburicase antibodies in the context of~     hypersensitivity reaction(s) or the loss of uricolytic activity occurring in patients with~     relapsed leukemia/lymphoma who have been re-treated with rasburicase and have experienced a~     hypersensitivity reaction or loss of uricolytic activity.~   "
188486|NCT01097356|"~     Aim: In this project proposition the investigators would like to examine the effect of immune~     modulation by probiotics on the clearance of HPV-infections.~      This study provides a model for viral infection but also for cancer precursors. This would be~     an excellent model (and the only possible short-term model) to examine an effect on cancer~     precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically~     accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies.~      Research question: Does daily intake of probiotics lead to a better immune-response in~     HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of~     cytological lesions?~   "
188487|NCT01097343|"~     Loss-of-function mutation of the gene encoding the CYP450 2C19 enzyme has emerged as a likely~     determinant of resistance to clopidogrel therapy. The primary hypothesis of the proposed~     research is that among patients with confirmed loss-of-function alleles of the CYP2C19 gene,~     increasing the maintenance clopidogrel dose from 75 to 150 mg will result in significant~     reduction in the rate of measured clopidogrel resistance defined by multiple measures of~     platelet function~   "
188488|NCT01097330|"~     Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring~     back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as~     ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat~     when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This~     study is designed to determine the best way to manage patients who have an ICD and who~     continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and~     2) Medication.~      An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area~     and threading it into the heart. After the doctor has located the affected area responsible~     for the VT, radiofrequency energy is delivered by the power generator through the catheter to~     the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart~     tissue thought to cause the VT.~      A medication called Amiodarone is an anti-arrhythmic prescribed to prevent abnormal heart~     rhythms from recurring.~      The purpose of this study is to compare these two different methods for treating VT.~     Treatment with ablation and amiodarone are both considered the standard of care for patients~     with VT but they have not been compared directly in a study like this before.~   "
188489|NCT01097317|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and vinorelbine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Chemotherapy can lead to a loss of leg muscle strength. Neuromuscular electrical~     stimulation may improve muscle strength and quality of life. It is not yet known whether~     chemotherapy given together with neuromuscular electrical stimulation is more effective than~     chemotherapy alone in treating patients with non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying first-line chemotherapy given together~     with neuromuscular electrical stimulation to see how well it works compared with chemotherapy~     alone in treating patients with non-small cell lung cancer.~   "
188490|NCT01097304|"~     This pilot phase II trial studies how well ursodiol works in treating patients with Barrett~     esophagus or cells that look abnormal under a microscope but are not cancer (low-grade~     dysplasia). Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of ursodiol may keep cancer for forming in patients with Barrett esophagus or low-grade~     dysplasia.~   "
188491|NCT01097278|"~     RATIONALE: Cholecalciferol may prevent breast cancer in premenopausal women.~      PURPOSE: This randomized phase II trial is studying how well cholecalciferol works in~     preventing breast cancer in premenopausal women.~   "
188492|NCT01097265|"~     RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may help doctors find~     patients who are at risk of developing micrometastases and plan better treatment.~      PURPOSE: This randomized phase II/III trial is studying micrometastases in patients with~     stage I or stage II localized colon cancer that can be removed by surgery.~   "
188493|NCT01097252|"~     Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and~     response rates with the weekly cisplatin based chemoradiation in the treatment of~     locoregionally advanced cervical cancers.~   "
188557|NCT01096407|"~     RATIONALE: Learning about pain in patients with cancer receiving paclitaxel may help plan~     treatment and may help patients live more comfortably. Studying samples of urine from~     patients with cancer in the laboratory may help doctors identify and learn more about~     biomarkers related to muscle and joint pain.~      PURPOSE: This phase I trial is studying the role of biomarkers in muscle pain and joint pain~     in patients with solid tumors receiving paclitaxel.~   "
188494|NCT01097239|"~     This is a single centre pilot trial to establish the feasibility and role of endoluminal HIFU~     in patients with locally advanced cancer within the pelvis that is either primary or~     recurrent and with all available current therapy inappropriate and/or exhausted.~      The aim is to make a preliminary assessment of efficacy & dosage for evaluation in a~     randomised controlled trial. Whilst efficacy data are limited in a small feasibility study;~     radiological, biochemical and histopathological analysis of the patient and patient~     specimens, along with quality of life questionnaires (QoL), will be used to provide~     preliminary measures of efficacy in this patient cohort.~      These analyses will allow examination of the biochemical, metabolomic and histological~     changes associated with HIFU treatment in cancer within the pelvis.~   "
188495|NCT01097226|"~     The main purpose of this study is to determine the oral bioavailability of flavanols~     (polyphenolic compounds) from apple granules and an apple extract delivered in a water based~     beverage at two different doses. We will also investigate the effects of apple flavanols on~     nitric oxide production.~   "
188496|NCT01097213|"~     Forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1~     (Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted~     Self-administration of Ethanol (CASE); ClinicalTrials.gov identifier: NCT01063166). The~     functional magnetic resonance imaging blood-oxygen-level-dependent (fMRI BOLD) activity~     related to disinhibition measured with the Stop Signal task will be assessed during a~     continuous infusion of alcohol, clamping the arterial Breath Alcohol Concentration (aBAC) at~     60 mg% for approximately one hour. It will be examined whether this fMRI BOLD activity is~     associated with the initial drinking trajectories and the alcohol consumption at age 18 and~     at age 20 identified in specific aim 1. Furthermore, fMRI will be used with the Taylor~     Aggression Paradigm to determine which brain areas mediate increased physical aggression~     during the same continuous infusion of alcohol as described above. All participants will~     undergo an alcohol and a placebo fMRI session.~   "
188497|NCT01097200|"~     Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the~     prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be~     effective but it requires a long learning curves and is more aggressive. New meshes~     techniques seem to be effective, as well, with less learning curve but they are expensive and~     there are no randomize studies published.~      The investigators aim is to compare both techniques in terms of: anatomical and functional~     efficacy, cost, operating time and complications.~   "
188498|NCT01097174|"~     This study is to evaluate the long-term safety, effectiveness and clinical experience of the~     CyPass Micro-Stent in patients with glaucoma.~   "
188499|NCT01097161|"~     Subjects' utterances were submitted to acoustic analysis before and after the intervention~     program applied on prosodic basis.~   "
188500|NCT01097148|"~     Rationale: Obesity is an increasing health risk worldwide, with the USA recording prevalence~     in adults of around 20%. The mean body weight of obese patients is also increasing. One of~     the strategies to treat extreme obesity (Body Mass Index (BMI) > 40 kg/m2) is weight-reducing~     surgery like laparoscopic gastric banding or gastric bypass. During anaesthesia, morbidly~     obese patients are exposed to an increased risk at developing postoperative wound infections,~     apnoea and thrombotic events and may be more difficult to intubate. Routinely, amongst~     others, cefazolin, morphine, nadroparin and atracurium are administered in standard dosages.~     However, it is not known to what extend the pharmacokinetics and/or -dynamics of these drugs~     are affected in morbidly obese patients. Therefore, evidence-based dosing schedules for these~     drugs in morbidly obese patients should be developed.~      Objective: The study is performed in order to develop population pharmacokinetic and/or~     pharmacodynamic models of the routinely used drug therapies during bariatric surgery in~     morbidly obese patients (BMI > 40 kg/m2): cefazolin, morphine, nadroparin and atracurium.~      A covariate analysis will be performed in order to account for variability in pharmacokinetic~     and/or pharmacodynamic parameters. This covariate analysis will take into account procedure~     and patient bound covariates, with specific interest for body weight as a covariate. Whenever~     possible, non-obese patients will be included in the covariate analysis.~      The results will be used to develop individualised dosing schemes for routinely used drugs~     peri-operatively in morbidly obese patients.~      Study design: A randomised, prospective, observational, therapeutic and invasive study.~      Study population: Morbidly obese patients with a Body Mass Index > 40 kg/m2 undergoing~     laparoscopic banding or gastric bypass surgery, 18-60 years old. A total of 20 patients will~     be included in the study.~      Intervention (if applicable): All measurements and data collection will take place around~     administration of drugs that are given according to routine clinical practice (cefazolin 2~     grams for prophylaxis of infections, morphine 10 mg intravenously at the end of surgery, a~     patient-controlled analgesia (PCA) pump with morphine for postoperative pain relief and~     nadroparin 0,6 ml for trombo-embolic prophylaxis). For muscle relaxation, patients are~     randomised to receive one of two generally accepted dosing regimen of atracurium (0.5 mg/kg~     based on ideal body weight or 0.5 mg/kg based on total body weight). Peri- and~     postoperatively, a maximum amount of 70 ml of blood will be collected from an indwelling~     arterial line for measurement of concentrations of cefazolin, morphine, and anti-Xa~     (nadroparin). One week after surgery the patient will be checked for thrombosis using~     ultrasonography.~      Main study parameters/endpoints:~      Primary endpoints to evaluate in morbidly obese patients are;~        -  pharmacokinetic parameters of cefazolin in blood;~        -  pharmacokinetic parameters of morphine and metabolites in blood;~        -  time course of anti-factor Xa levels in blood following nadroparin;~        -  time course of the pharmacodynamic effect of atracurium.~      Secondary endpoints to evaluate in morbidly obese patients are:~        -  to compare primary endpoints (obtained in morbidly obese patients) with data of~          non-obese patients~        -  the occurrence of postoperative wound infections;~        -  postoperative pain scores, sedation scores and nausea scores;~        -  the occurrence of bleedings or thrombotic events ;~        -  required amounts of morphine (PCA);~        -  to compare the time course of the pharmacodynamic effect of two different doses of~          atracurium.~   "
188501|NCT01097135|"~     Surgical skin complications can be costly and could contribute to extended in-patient stay~     following total joint replacement or even the need for re-admission. If efficacy in reducing~     the incidence of post-operative wound drainage and, in turn, surgical wound complications can~     be demonstrated, it may also reduce the length of hospital stay and the need for revision~     surgery or readmission. The aim of this research is to investigate the incidence of~     post-operative wound drainage following elective total joint arthroplasty using two surgical~     skin preparation protocols.~   "
188502|NCT01097122|"~     This study hypothesize that radius subjecting to mechanical loading may affect excitability~     of alpha motor neuron innervating muscle, based on its bone mineral density or bone mineral~     content.~      A total of 80 voluntaries are planned to include in this study. Vibration will be applied the~     right forearm. Muscle electrical activity will be measured on ipsilateral and contralateral~     flexor carpi radialis (FCR) muscle at rest as EMGrms by surface electromyography (EMG). The~     rest-EMGrms will be measured at before and during vibration. An increase in muscle electrical~     activity at rest indicates an increase in motor neuron pool activation. The right distal~     radius bone mineral content (BMC) and density will be measured by dual energy X-ray~     absorptiometry (DXA).~      The right radius bone mineral density (BMD) and BMC will be evaluated by bone densitometer~     (GE-LUNAR DPX PRO).~      Motor unit potentials will be measured by electromyography at left flexor carpi radialis.~     Neurotrac ETS device will be used.~   "
188503|NCT01097109|"~     The study aims to determine if somatic dysfunctions of the pelvis, sacrum and lower lumbar~     spine have an effect on weight bearing. Our subjects are young, healthy subjects without~     recent soft tissue or osseous injury, a less than predetermined leg length discrepancy or~     OMM/chiropractic treatment. Their leg lengths will be measured; weight-bearing will be~     measured using a specialized scale and somatic dysfunctions diagnosed to determine if any~     correlation exists.~   "
188504|NCT01097096|"~     This study will assess the safety, tolerability and Abeta-specific antibody response of~     repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's~     Disease.~   "
188505|NCT01097083|"~     The hypothesis of this study is that the median time to progression in the experimental arm~     is 2 months as compared to the placebo arm of 1.4 months~   "
188506|NCT01097070|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics~     (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals.~   "
188507|NCT01097057|"~     This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and~     etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor~     works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous~     peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as~     rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them~     and helps get better autologous stem cell product. Giving colony-stimulating factors, such as~     G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so~     they can be collected and stored for future autologous transplant.~   "
188558|NCT01096394|"~     RATIONALE: Collecting and storing samples of tumor tissue and ascites fluid from patients to~     test in the laboratory may help the study of cancer.~      PURPOSE: This pre-clinical research study is collecting tissue samples and ascites fluid from~     patients with stage III or stage IV ovarian/primary peritoneal/fallopian tube epithelial~     cancer.~   "
188508|NCT01097044|"~     This is a randomized placebo-controlled study to be conducted in two parallel study arms for~     a six month period (three doses). Approximately 10 eligible patients per center will be~     enrolled and will receive afamelanotide (16 mg implants) or placebo according to the~     following dosing regimen:~        -  Group A will be administered afamelanotide implants on Days 0, 60 and 120~        -  Group B will be administered placebo implants on Days 0, 60 and 120~      To determine eligibility for study inclusion, patients will undergo a screening evaluation 7~     to 14 days prior to the administration of the first dose. The number and severity of~     phototoxic reactions will be determined Days 60, 120, and 180. Quality of life will be~     measured every 7 days, beginning at Day 0 until Day 180. Participants will visit the clinic~     on Days 60, 120 and 180 for assessments of adverse events.~   "
188509|NCT01097031|"~     Randomized Clinical Trial to evaluate which is the best infusion system of heparin solution~     for Keeping the mean invasive blood pressure whether the continuous system and the~     intermittent one.~   "
188510|NCT01097018|"~     The trial will compare the overall survival of perifosine plus capecitabine to placebo plus~     capecitabine in patients with refractory advanced colorectal cancer.~   "
188511|NCT01097005|"~     To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients~     with Non-tuberculous Mycobacterial Pulmonary Infections.~   "
188512|NCT01096992|"~     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of~     bendamustine, combined with fludarabine and rituximab, that can be given to patients who have~     CLL that has been treated before.~      The goal of Phase 2 of this study is to find out if this drug combination can help to control~     the disease. The safety of this drug combination will also be studied.~   "
188513|NCT01096979|"~     This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction~     of subcutaneous abdominal adiposity.~   "
188514|NCT01096966|"~     This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch)~     compared to placebo in patients with chronic low back pain.~   "
188515|NCT01096953|"~     1. It is difficult to offer kids who live in rural areas good psychiatric care. There are~          only about 7000 psychiatrists for kids (pediatric psychiatrists) in the entire country.~          When adding nurse practitioners who specialize in mental health care for children, there~          still are not enough for everyone who needs care. This means either delays in treatment~          or no treatment at all by these important specialists. The purpose of this study is to~          explore how the investigators might offer psychiatric care to kids who live in rural~          areas through the use of telepsychiatry (TP), specifically those with attention~          deficit/hyperactivity disorder (ADHD).~           TP is a way for a physician to talk to someone in a remote area using a computer. The~          investigators will split the subjects into two study groups. As subjects are identified,~          they will be assigned a screening number according to a randomization table. The~          investigators will use TP for one group and face-to-face (F2F) care for the other group.~          The computer will allow the physician to look at and talk with the child and their~          parent(s). The investigators would like to know if TP is as good as, or nearly as good~          as F2F care, so the only difference in treatment approach between the two groups will be~          whether the subject is receiving treatment through TP or F2F care. Treatment is~          standardized using a flow chart called the Children's Medication Algorithm Project~          (CMAP) algorithm. The CMAP algorithm is a guideline established by a large number of~          experts who have agreed on the best approach to treatment based on scientific evidence.~          If TP proves as good as F2F care, it would help many parents and their children who do~          not live in or near a large city.~        2. The investigators will find study subjects when parents seek care at clinics in rural~          Oregon. The physicians in those locations will be aware of the study and will tell us~          when they think someone needs specialized mental health professional (either a pediatric~          psychiatrist or nurse practitioner with extensive experience in pediatric mental~          health). The investigators will make sure that ADHD is the right diagnosis using special~          exams that have been well-tested to show that they are reliable.~        3. The first visit—the intake visit—will probably take about an hour. At that visit, mental~          health professional will determine whether or not the patient is a candidate for the~          study. If the patient agrees, they will be asked to sign consent and child assent. The~          parent and child will then be given an exam that will confirm the diagnosis of ADHD. If~          confirmed, subjects will then learn if they have been assigned to the TP group or the~          F2F group and will be assigned to the treating mental health professional. In addition~          to the DISC, after consent the parent will be given several study instruments to take~          home with them. They will take about an hour altogether to complete.~           The first visit with the treating mental health professional will take about one hour~          and the three following visits will take about 30 minutes each. These visits will be~          about six weeks apart. At the third follow-up visit—the final visit—the parents will be~          again asked to complete the instruments they completed after consent and will be asked~          to complete a brief questionnaire that will give them the opportunity to describe their~          satisfaction or dissatisfaction with the treatment and care they received.~           Teachers will be asked to complete the Conner's 10-Item Global Index for the subject~          twice over the course of the study. The parent of the subject will present the scale to~          the teacher and retrieve the scale in a sealed envelope to return to the clinic.~        4. The diagnosis for ADHD will be made using an exam called the Diagnostic Interview~          Schedule for Children Version IV (DISC IV). This is a 90-minute exam that is done with a~          computer that helps you know what questions to ask and helps record the responses. The~          parents will also be asked to complete a few instruments and surveys that help us~          understand how well treatment is working. The investigators expect these exams to take~          about half an hour to complete. They contain questions about the subject's behavior and~          are completed by parents, except one brief instrument that the investigators will ask~          and teachers to complete before each follow-up visit. These instruments take about 10~          minutes each to complete.~        5. This is an initial pilot study, so the information collected will mainly offer a~          better understanding of whether or not a larger study is possible. The investigators~          will look at how many subjects stayed in the study or dropped out and when they dropped~          out. The investigators will also look at the exams, scoring them to help us understand~          if those who were part of the TP group did as well, or nearly as well, as those in the~          F2F group.~   "
188516|NCT01096940|"~     To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.~   "
188517|NCT01096927|"~     Case control studies that randomly assign patients to either surgical or non-surgical~     treatment yield a relapse rate of approximately 14% at one year. It would be useful to know~     the relapse rate of patients who have, instead, been selected for a given treatment based on~     a thorough clinical evaluation, including physical examination and laboratory results (all~     characteristics forming the Alvarado Score) as well as radiological exams if needed or deemed~     helpful. If this clinical evaluation is useful,the investigators would expect patient~     selection to be better than chance, and relapse rate lower than 14%. Once the investigators~     have established the utility of this evaluation, the investigators can begin to identify~     those components that have predictive value (such as blood chemistry analysis, or CT~     findings). This is the first step toward developing an accurate diagnostic-therapeutic~     algorithm which will avoid the risks and costs of needless surgery.~      This will be a single-cohort prospective interventional study. It will not interfere with the~     usual procedures, consisting of clinical examination in the Emergency Department (ED) and~     execution of the following exams at the physician's discretion: complete blood count with~     differential, C reactive protein, abdominal ultrasound, abdominal CT. Patients admitted to~     Emergency Department with Lower Abdominal and suspicion of Acute Appendicitis not needing~     immediate surgery, are requested by informed consent to undergo observation and non operative~     treatment with antibiotic therapy (Amoxicillin and Clavulanic Acid). The patients by protocol~     should not have received any previous antibiotic treatment during the same clinical episode.~     Patients not undergoing surgery will be physically examined 5 days later. During this~     follow-up visit, the patient will be given information about the study, will be invited to~     participate, and will be asked to sign an informed consent form. If the patient is under the~     age of 18 years, consent will be obtained from a parent or other legal guardian.~      Telephone (or email) follow-ups will be conducted at 15 days, 6 months, and 12 months (see~     attached schedule) to monitor the state of the illness.~   "
188518|NCT01096914|"~     The purpose of this study is to prospectively compare percutaneous radiofrequency ablation~     (RFA) versus percutaneous laser ablation (LA) for the treatment of small hepatocellular~     carcinoma in patients with cirrhosis.~   "
188519|NCT01096901|"~     This study is investigating the changes in specific hormone levels in women age 30-45 after a~     12 week weight loss intervention.~   "
188520|NCT01096888|"~     The purpose of this study is to provide weight loss interventions for Mothers participating~     in the WIC program, using the internet to deliver weight loss materials.~   "
188521|NCT01096875|"~     Experimental data have demonstrated favourable effects of statins on endothelial progenitor~     cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present~     prospective randomized controlled trial is to determine the effects of aggressive~     atorvastatin treatment (40 mg daily 2-weeks prior to surgery) on the number of endothelial~     progenitor cells (EPCs) after cardiopulmonary bypass by comparing with placebo.~   "
188522|NCT01096862|"~     The purpose of this study is to explore the efficacy and safety of multiple, escalating doses~     of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.~   "
188523|NCT01096849|"~     Multi-center, multi-national, double-blind, randomized, comparator-controlled study of~     plazomicin administered intravenously compared with levofloxacin, a standard approved~     intravenous therapy for complicated urinary tract infection (cUTI) and acute pyelonephritis~     (AP).~   "
188524|NCT01096836|"~     The purpose of this study was to compare the effects of two different diets (low carbohydrate~     - LCD and conventional - CONV) on body composition, strength performance, muscle mass and~     biomarkers of health in overweight adults submitted to resistance training (RT). It has been~     hypothesized that LCD would produce higher rates of weight loss and that both diets would be~     useful to maintain muscle mass and strength and biomarkers of health.~   "
188525|NCT01096823|"~     The purpose of this study is to compare a standardized 6 week Iyengar Yoga program (IYP) for~     adolescents and young adults with rheumatoid arthritis to a standard care wait-list~     condition. In addition to effects on function and pain, this study will explore intervention~     effects on disease activity, immune response, HRQOL, functionality, and mood. Results will~     shed light on the feasibility and potential efficacy of a novel intervention (Iyengar yoga)~     for rheumatoid arthritis symptoms.~      The hypotheses are:~        1. The IYP will be safe, acceptable and feasible: at least 80% of subjects will complete~          the IYP.~        2. Following the IYP, participants will show significantly improved disease status, general~          functioning, arthritis-functioning and HRQOL relative to controls. The benefits will be~          apparent post-treatment and at two-month follow-up.~        3. Following the IYP, participants will report significantly improved pain, immune response~          and mood compared to controls. These improvements will be evident at both post-treatment~          and at two-month follow-up.~   "
188526|NCT01096810|"~     Purpose:~      The purpose of this study is to see if TBL 12, which is a blend of Sea Cucumber, Sea Sponge,~     Shark Fin, and Sea Urchin (animals that live in the Pacific Ocean) as well as Sargassum (a~     plant that lives in the Pacific Ocean), will have effects against asymptomatic multiple~     myeloma and to see what the side effects are.~      Eligibility:~      Several criteria must be met to be eligible for this study, including but not limited to the~     following:~        -  a diagnosis of asymptomatic multiple myeloma~        -  adequate cardiac, liver and kidney function~        -  age 18 and older~   "
188527|NCT01096797|"~     The purpose of this study is to determine the incidence of pain, emergence delirium and the~     combination of those postoperative negative behaviours during the first 15 minutes after~     awakening from sevoflurane anesthesia in pre-school children. Additionally this study will~     evaluate the relationship between emergence delirium and postoperative pain behaviour after~     adenotonsil surgery.~   "
188528|NCT01096784|"~     To compare the severity of retinopathy of prematurity (ROP) among treated infants with an~     untreated control population, matched for gestational age at birth while confirming the dose~     of rhIGF-1/rhIGFBP-3 is safe and efficacious.~   "
188529|NCT01096771|"~     The purpose of this study is to evaluate the effects of nutritional supplementation with~     omega-9 olive-oil and omega-6 soybean oil based lipid emulsions in the Acute Respiratory~     Distress Syndrome (ARDS). The investigators hypothesize that these specific lipids in~     combination will immunomodulate the inflammatory reaction that occurs in the lungs of ARDS~     subjects. This concept is known as Pharmaconutrition. These lipids will be given~     intravenously so as to assure administration and only as a supplement to enteral nutrition~     which all subjects will also receive. The omega-9 will be compared to the omega-6 formulation~     which is the only FDA approved formulation of use in the United States since its development~     in 1961 by Fresenius-Kabi, Bad Homburg, Germany. The investigators plan to perform a~     bronchoscopy with lavage within 24 hours of enrollment, begin the lipid administration and~     continue it for 96 hours after which time the investigators will repeat bronchoscopy with~     lavage to assess changes. The lipid administration will cease following the second~     bronchoscopy. The fluid obtained from lavage combined with serum samples obtained at the time~     of bronchoscopy will be analyzed for inflammatory mediators and cell counts. Clinical data~     tracing will include but not be limited to: ventilator days, nutritional status, ICU time,~     oxygenation and lung compliance, and 30-day mortality.~   "
188530|NCT01096758|"~     Adult patients with phenylketonuria (PKU) at the age around 40 years belong to the first~     patients generation with early treatment of the disease. PKU is caused by an inborn error of~     the amino acid metabolism and the so far best suitable therapy is an early and strict diet,~     which is low in phenylalanine.~      Besides an early and continuously treatment in childhood, the nutritional and medical support~     during adolescence and adulthood have been suggested to influence the long-term physical~     health of adult PKU patients. As many adult PKU patients tend to neglect the necessarily~     strict diet, they do not get a balanced diet. For PKU patients some nutrients, which may be~     rare in an unbalanced diet, might help to improve health status, physical and neurological~     performance and quality of life.~      Information about the longitudinal development of the patients status and the influence of~     the type of their medical care is not available. In this 5 year follow-up the investigators~     aim to study the quality of life and the medical, nutritional and psychological status of~     adult PKU patients, in whom corresponding information has already been collected previously.~   "
188531|NCT01096745|"~     The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and~     S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.~   "
188532|NCT01096732|"~     This clinical trial is looking at the effect of a new drug called GDC-0449 in patients with~     cancer of the pancreas. Laboratory studies have shown that this drug blocks a process in~     pancreatic cells thought to be involved in cancer development and spread. This process is~     called the 'Hedgehog signalling pathway'. As yet, it is unclear whether blocking hedgehog~     signalling will directly affect the tumour cells themselves or the surrounding normal tissue.~     Understanding this distinction will help improve treatment strategies for pancreatic cancer.~     Patients will be offered to participate in this research study if they have localised~     pancreatic cancer that can be removed by surgery. In the period between diagnosis and surgery~     the investigators do not normally treat patients, however in this trial the investigators~     will ask patients to take GDC-0449 during the approximately two weeks until the day of~     surgery. All patients that enter this study will have undergone a diagnostic biopsy of the~     pancreatic tumour and the investigators will collect a second sample of the tumour at~     surgery. The main question of this study is whether the investigators can detect a change in~     hedgehog signalling in the normal tumour surrounding tissue. Furthermore the investigators~     will look very carefully whether this treatment is safe for patients. All problems before and~     after surgery will be carefully documented and the investigators have defined strict rules to~     stop the study if the investigators observe serious problems.~   "
188533|NCT01096719|"~     The purpose of this investigation is to conduct a 12-week pilot study to examine the effect~     of three different dietary prescriptions that differ on targeting reducing energy density~     (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation,~     satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a~     12-week behavioral weight loss intervention.~   "
188540|NCT01096628|"~     Recent research has confirmed that low back pain (LBP) is a significant health problem not~     only for adults, but also for children and adolescents. Given the enormous social and~     economic costs associated with LBP, it is critical that attempts be made to decrease the~     burden of LBP for patients and society.~      The primary aim of this project is to determine the relative clinical effectiveness of 3~     months of chiropractic care and supervised exercise versus supervised exercise in 184~     adolescents with sub-acute recurrent, or chronic LBP. Relative effectiveness will be~     evaluated in the short, intermediate and long term using pain as the primary outcome measure.~     Secondary aims are to assess group differences in patient self-reported disability, quality~     of life, perceived improvement, satisfaction, activity levels, lumbar dynamic motion, and~     trunk muscle endurance. Patients' and caregivers' perceptions of treatment using qualitative~     interviews will also be assessed.~   "
189633|NCT01082354|"~     This one-arm, multi-centric, non-randomized, observational, open label, prospective study was~     designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians~     in private, mixed private and hospital practice treated with Saizen.~   "
188534|NCT01096706|"~     Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem~     with a poor prognosis and the search for novel treatments remains an important area of~     research.~      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There~     has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in~     heart failure.~      In this study, we will examine the effects and mechanisms of Urocortins 2 & 3 on forearm~     blood flow and release of natural blood clot dissolving factors in the forearm circulation of~     healthy volunteers. In particular, we look at the endothelial mechanisms of vasodilatation of~     Urocortin 2 and 3.~      In this study, we will look at the role of the lining of the blood vessel (endothelium) in~     response to urocortin types 2 and 3. We hypothesise that urocortins 2 & 3 act via the~     endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen~     activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a~     role in maintaining the normal baseline level of blood flow in forearm arteries. In addition~     to the above, we will also look at the effect of temporarily blocking the effect of~     urocortins, using a specially designed blocker drug (Astressin 2B).~      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we~     will be able to focus on the local effects of urocortins on arterial blood flow in forearm~     vessels, without affecting this system in the body as a whole.~   "
188535|NCT01096693|"~     Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem~     with a poor prognosis and the search for novel treatments remains an important area of~     research.~      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There~     has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in~     heart failure.~      In this study, we will examine the effects and mechanisms of Urocortins 2 & 3 and the~     Corticotrophin Releasing Hormone Receptor Type 2 (CRH-R2) receptor (through which urocortins~     act) on forearm blood flow and release of natural blood clot dissolving factors in the~     forearm circulation of healthy volunteers.~      In this study, we will look at the role of the lining of the blood vessel (endothelium) in~     response to urocortin types 2 and 3. We hypothesise that urocortins 2 & 3 act via the~     endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen~     activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a~     role in maintaining the normal baseline level of blood flow in forearm arteries. In addition~     to the above, we will also look at the effect of temporarily blocking the effect of~     urocortins, using a specially designed blocker drug (Astressin 2B).~      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we~     will be able to focus on the local effects of urocortins on arterial blood flow in forearm~     vessels, without affecting this system in the body as a whole.~   "
188536|NCT01096680|"~     This is a double-blind, single center, parallel group, placebo and active comparator,~     controlled study to characterize the wake promoting effects of single doses of SPD489 in~     healthy adult male undergoing acute sleep deprivation.~   "
188537|NCT01096667|"~     MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational~     drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and~     hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either~     placebo, 1 of 3 doses of ertugliflozin [1, 5, or 25 mg], or the approved drug~     hydrochlorothiazide [HCTZ]). The primary hypothesis of the study was that ertugliflozin was~     superior to placebo on the change from baseline in average, 24-hour systolic blood pressure~     (SBP) on Day 28.~   "
188538|NCT01096654|"~     Rationale: Primary hyperaldosteronism (PA) is the most frequent form of secondary~     hypertension. In PA autonomous hypersecretion of aldosterone by one or both adrenal glands~     causes hypertension that is often refractory to treatment. PA is usually caused by either a~     unilateral aldosterone-producing (micro)adenoma (APA) or by bilateral adrenal hyperplasia~     (BAH). Distinction between APA and BAH is critical since the former is treated with the aim~     of cure by adrenalectomy, and the latter by mineralocorticoid receptor antagonists. This~     distinction can be made by adrenal vein sampling (AVS), as recommended by The Endocrine~     Society 2008 guideline or by CT-scanning, as is common practice in the Netherlands. AVS is~     invasive, demands great skill, and is expensive, while CT-scanning is non-invasive, easy and~     cheap, but might be less accurate. However, the advantage of AVS has never been demonstrated~     in prospective randomized studies. Here we propose to perform a prospective, randomized,~     multicenter study that compares effectiveness of AVS with effectiveness of CT-scanning for~     the diagnosis of PA subtype.~      Objective: To assess the quantity of antihypertensive medication needed in order to normalize~     blood pressure in patients who have been managed for PA according to either AVS or CT-scan.~     Secondary objectives: to assess potassium, costs of management and quality of life.~      Study design: Prospective, randomized trial in a multi-centre setting. Two hundred patients~     will be recruited within two years. Follow-up will be one year after (start of) treatment.~      Study population: Adult patients with therapy-resistant hypertension, with or without~     hypokalemia, caused by PA.~      Intervention: Patients will be randomized to undergo either adrenal CT-scanning or AVS (with~     pre-AVS adrenal CT-scanning for phlebography). The result of either of these tests will~     determine the course of action: adrenalectomy for adenoma or MRAs for bilateral hyperplasia.~      Main study parameters/endpoints: The quantity of antihypertensive drugs patients are using to~     obtain target blood pressure, expressed in Daily Defined Dosages, is used as the main study~     parameter. There is no criterion standard for accuracy of the diagnosis of PA-subtype, but we~     assume that if treatment is based on a more accurate diagnosis, treatment is more effective.~     The most important secondary endpoints are the costs of the diagnostic course and long-term~     medical treatment and the quality of life as assessed by a validated questionnaire.~   "
188539|NCT01096641|"~     Postcancer fatigue is a severe and invalidating problem, impairing quality of life. About 20~     to 40% of the patients remain fatigued, at least one year after successful cancer treatment.~     Fortunately, there is an effective treatment for postcancer fatigue; cognitive behavior~     therapy. However, no cause for postcancer fatigue has been identified yet. The aim of the~     study is to identify factors that (partly) cause postcancer fatigue to improve the~     theoretical understanding of fatigue and to improve the diagnostics of fatigue, predict~     therapy outcome, and facilitate other treatment options.~      In this study, disease-free fatigued cancer patients, who finished treatment for cancer at~     least one year and maximally ten years ago, will be approached for this study. They will be~     compared to non-fatigued patients.~      First, a baseline assessment will take place. Magnetic resonance imaging of the brains will~     be performed to assess brain volume and magnetic resonance spectroscopy will be performed to~     measure the concentrations of specific substances in the brains. Changes in the volume of~     parts of the brains have been observed in (non-cancer) patients with the chronic fatigue~     syndrome (CFS), in comparison with healthy controls. In addition, abnormal concentrations of~     specific substances have been observed in patients with CFS compared to healthy controls. To~     assess muscle fatigue, a two-minute endurance test of the upper arm will be administered at~     maximal voluntary contraction. Next to differences in the brains, CFS patients showed~     (central) muscle fatigue. A maximal exercise test on a bicycle will be performed to assess~     physical fitness. Physical activity in fatigued cancer survivors is decreased, compared to~     healthy controls. It is not known whether physical deconditioning originated during the~     cancer treatment is the reason why these patients are still less active. In addition,~     patients and controls will wear an actometer for two weeks to register baseline daily~     physical activity and for an additional 5 days after the maximal exercise test, to assess the~     effect of exercise on the daily physical activity. Finally, patients and controls will~     complete standardized questionnaires and will perform neurological/psychological tests, like~     a reaction time test and a short time memory task, at baseline.~      The results of the non-fatigued and the fatigued patients will be compared at baseline. For~     the non-fatigued participants, the study will be finished after the baseline measurements.~     The fatigued participants will start with cognitive behavior therapy immediately after the~     baseline measurements or after 6 months, depending on the randomization.~      At the end of the therapy, after six months, or after 6 months of waiting for cognitive~     behavior therapy, a second assessment will take place, comparable to the baseline~     measurements. These results will be compared with the baseline situation to analyze the~     effect of cognitive behavior therapy on the (possible) causes of postcancer fatigue.~   "
188542|NCT01096602|"~     Acute myelogenous leukemia (AML) arises from leukemia stem cells that are difficult to~     eradicate and serve as a reservoir for disease relapse following chemotherapy. A promising~     area of investigation is the development of immunotherapeutic approaches that stimulate the~     immune system to recognize leukemia stem cells as foreign and eliminate them. The purpose of~     this research study is to determine the safety of the Dendritic Cell AML Fusion Vaccine (DC~     AML vaccine) after participants have achieved a remission with chemotherapy. In this clinical~     trial, patients are treated with a tumor vaccine alone following standard of care~     chemotherapy. The DC AML vaccine is an investigational agent that tries to help the immune~     system to recognize and fight against cancer cells. It is hoped that DC AML vaccine will~     prevent or delay the disease from coming back.~   "
188543|NCT01096589|"~     Objectives. The primary objective of the study is to assess volume reduction in the treatment~     of lymphoedematous legs and arms with compression bandaging.~      Secondary objectives:~        -  Assessment of safety~        -  Quality of life~        -  Health economic parameters~        -  Slippage~        -  Subbandage pressure~   "
188544|NCT01096576|"~     This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the~     safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue~     virus infection whose symptoms began within the 48 hours preceding the first administration~     of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally~     twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an~     out-patient follow-up to week 12. Target sample size is <200~   "
188545|NCT01096563|"~     This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study~     to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after~     administration of single and Multiple Ascending doses in Japanese subjects.~   "
188546|NCT01096550|"~     The purpose of this study is to compare the effectiveness of different levels of counseling~     (intensive outpatient versus standard outpatient) on treatment outcomes for African American~     adult patients receiving buprenorphine in 2 formerly drug-free programs.~   "
188547|NCT01096537|"~     Background: Occupational exposures are thought to be responsible for 10-15% of new-onset~     asthma cases in adults, with disparities across sectors. Because most of the data are derived~     from registries and cross-sectional studies, little is known about incidence of occupational~     asthma (OA) during the first years after inception of exposure. This study focuses on this~     early asthma onset period among young workers in the bakery, pastry making and hairdressing~     sectors in order to assess early incidence of OA in these at risk occupations according to~     exposure duration, and to identify risk factors of OA.~      Methods: This study is a longitudinal retrospective study with a nested case-control to~     identify risk factors of OA. The assessment of incidence evolution is made by exploring a~     series of promotions (or retrospective cohorts) with increasing duration since at work. The~     study population is composed of subjects who graduated between 2001 and 2006 in sectors where~     they experience exposure to organic or inorganic allergenic or irritant compounds (with an~     objective of 150 subjects by year) and 250 young workers with no specific occupational~     exposure.~      This study is a descriptive, monocentric, longitudinal and retrospective study with~     cross-sectional measurements.~   "
188548|NCT01096524|"~     Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting~     accelerated recovery of quadriceps function in patients recovering from total knee~     arthroplasty (TKA) as measured by increases in isometric strength of the knee extensors and~     scores in the Timed Up and Go (TUG) test.~   "
188549|NCT01096511|"~     This study is a local, prospective, open-label, company-sponsored, non interventional,~     multi-center study. Patients documented must suffer from a cIAI and take at least one dose of~     Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that~     require Moxifloxacin i.v. therapy in China.~   "
188550|NCT01096498|"~     A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover,~     randomized, prospective design was chosen with a washout of 21 days between the two study~     periods. Treatment groups were balanced with the same number of male healthy volunteers who~     were randomly assigned to the study drug administration sequences.~   "
188551|NCT01096485|"~     A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover,~     randomized, prospective design was chosen with a washout of 21 days between the two study~     periods. Treatment groups were balanced with the same number of male healthy volunteers who~     were randomly assigned to the study drug administration sequences.~   "
188552|NCT01096472|"~     The aim of this study is to determine the efficacy and safety of a topical application of the~     combinational cream LAS41003 compared to application of its mono-substances after once daily~     treatment in patients with inflammatory tinea pedis.~   "
188553|NCT01096459|"~     The goal of this study is to evaluate a surgical procedure (operation) that reroutes lumbar~     to sacral nerves in the spinal column to improve the bladder's ability to empty properly in~     patients born with Spina Bifida.~   "
188554|NCT01096446|"~     The purpose of this study is to study the tolerances of Extremely Low Birthweight Infants who~     are born at less than 750 grams who are started at a higher infusion rate of intravenous~     lipid emulsions (2 gm/kg/day). These infants will be compared with a control group who are at~     the standard lipid emulsion infusion rate (0.5 gm/kg/day).~      hypothesis:~      A. Objectives of this project.~      Null Hypothesis: There will not be a significant difference for Extremely Low Birth Weight~     Infants (ELBW) <750 grams being able to tolerate a higher infusion rate of Intravenous Fat~     Emulsions (IVFE) within the first days of life (days 1-7) as evidenced by maintenance of a~     serum triglyceride level of 200 mg/dl or less.~      Alternative Hypothesis: There will be a significant difference (p<0.05) for Extremely Low~     Birth Weight Infants (ELBW) <750 grams being able to tolerate a higher infusion rate of~     Intravenous Fat Emulsions (IVFE) within the first days of life (days 1-7) as evidenced by~     maintenance of a serum triglyceride level of 200 mg/dl or less.~   "
188555|NCT01096433|"~     The purpose of this study is to evaluate the associations of circadian variations, sleep~     architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, the~     patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of~     CPAP are also evaluated.~   "
189634|NCT01082341|"~     It is possible to safely protect human volunteers immunized with P. vivax irradiated~     sporozoites from P. vivax challenge with live sporozoites.~   "
188559|NCT01096381|"~     RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer~     receiving bevacizumab may help doctors learn more about changes that occur in DNA and~     identify biomarkers related to high blood pressure.~      PURPOSE: This phase I trial is studying potential biomarkers for bevacizumab-induced high~     blood pressure in patients with malignant solid tumors, including breast cancer, colorectal~     cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, fallopian tube~     cancer, or primary peritoneal carcinoma.~   "
188560|NCT01096368|"~     This randomized phase III trial is studying maintenance chemotherapy to see how well it works~     compared to observation following induction chemotherapy and radiation therapy in treating~     young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as~     vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation~     therapy that delivers a high dose of radiation directly to the tumor may kill more tumor~     cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may~     kill more tumor cells and allow doctors to save the part of the body where the cancer~     started.~   "
188561|NCT01096355|"~     This phase I trial is studying the side effects, best way to give, and best dose of~     gamma-secretase inhibitor RO4929097 in treating patients with metastatic or unresectable~     solid malignancies. Enzyme inhibitors, such as gamma-secretase inhibitor RO4929097, may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
188562|NCT01096342|"~     This phase II trial is studying how well giving dinaciclib works in treating patients with~     relapsed or refractory multiple myeloma. Dinaciclib may stop the growth of cancer cells by~     clocking some of the enzymes needed for cell growth.~   "
188563|NCT01096329|"~     The purpose of this study is to determine if the absorption of the testosterone spray is the~     same as the Intrinsa® Patch.~   "
188564|NCT01096316|"~     Major depressive disorder (MDD) is a common disabling illness that disproportionately affects~     women, with prevalence rates two times those of men. In addition to suffering, MDD has been~     shown to have a marked effect on social and vocational functioning, with increased~     disability, lost productivity, and excess mortality. Women with MDD have an increased~     prevalence of comorbid anxiety disorders and medical conditions.~      Our model of care utilizes a social worker as a depression care manager (DCM) to support both~     patients and physicians in optimizing care in the OB-GYN clinical setting. This intervention~     will be compared to usual care for depression.~   "
188565|NCT01096303|"~     The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen~     lung function as compared with persons that only smoke or smoked tobacco.~   "
188566|NCT01096290|"~     Constipation from medications is a serious and common condition. Lubiprostone has properties~     that make it a candidate drug. One hundred volunteers with constipation who are taking~     medications known to cause constipation will be randomized to take lubiprostone or placebo~     for 28 days. Therapeutic outcome will be evaluated by investigator and study subject~     assessment.~   "
188567|NCT01096277|"~     Glucagon-like peptide 1 (GLP-1) is a 30-amino acid gut hormone secreted in a~     nutrient-dependent manner that stimulates insulin secretion and inhibits glucagon secretion~     and gastric emptying, thereby reducing postprandial glycemia.1,2 GLP-1 is derived from~     posttranslational proteolysis of preproglucagon, and its peptide sequence is identical in~     mouse, rat, and human.2,3 After secretion from enteroendocrine L cells, GLP-1(7-36) amide is~     rapidly degraded by dipeptidyl peptidase-4 (DPP-4) to its N-terminally truncated metabolite~     GLP-1(9-36), which does not interact with the known GLP-1 receptor.4,5 The diverse actions of~     GLP-1 include the proliferation, differentiation, and protection from apoptosis of pancreatic~     β cells and the induction of satiety. GLP-1 also improves memory and learning, stimulates~     afferent sensory nerves, and has neuroprotective functions.1,6 Furthermore, GLP-1 receptor~     agonists have been reported to have cardiac and vascular actions in rodents and humans that~     include effects on contractility, blood pressure, cardiac output,7-10 and~     cardioprotection.11-14~   "
188568|NCT01096264|"~     Arterial stiffness is associated with increased risk of cardiovascular events and death.~      Most of existing technique need dedicated device for arterial stiffness evaluation and~     indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel~     non-invasive technique based on remote palpation of biological tissues that can image with~     very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic~     properties of tissues. The investigators goal was to apply this SSI technique for arterial~     stiffness evaluation and local pulse wave velocity (PWV) calculation.~      As a first step, the primary goal of this study is to establish normal values of local pulse~     wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy~     volunteers.~   "
188569|NCT01096251|"~     The STRATOB study is a two-arm randomized controlled clinical trial (RCT). The aims of this~     study are to compare the effectiveness of the BST (Brief Strategic Therapy) with the gold~     standard CBT (Cognitive Behavior Therapy) in a inpatient and telephone-based outpatient~     program in a sample of obese people with BED (Binge Eating Disorder) seeking treatment for~     weight reduction.~   "
188579|NCT01096121|"~     Patients with sickle cell anaemia may develop renal disease. In fact, renal disease occurred~     in 40% of adults patients (macroalbuminuria) with evolution to end-stage renal disease for~     half of them. Microalbuminuria is an early and sensitive marker of glomerular damage. It~     appears during the first decade and occurred in 20 to 25% of infants (2 to 18 years).~     Physiopathology of renal scarring is not well understood actually. Renal scarring might be~     due to glomerular hyperfiltration and vascular and endothelial damage. Angiotensin-converting~     enzyme inhibitors (ACE) were studied and used in diabetic nephropathy. In a study on 26~     sickle cell adults, albuminuria was reduced about 50% by ACE compared to placebo after six~     months treatment. It might be interesting studying ACE efficacy in sickle cell children with~     microalbuminuria because renal disease is directly related to sickle cell and is not~     influenced by other cardiovascular risk factors like in adult patients.~      We hypothesized to have a successful ACE treatment in more than 40% of cases after a nine~     months treatment period. A success is defined as a 50% reduction of the~     albuminuria/creatinuria ratio.~   "
188570|NCT01096238|"~     In the spring of 2009, a recently emerged novel influenza A (H1N1) virus was first identified~     in Mexico and USA and it has continued to spread globally. The rapid global spread of a novel~     influenza A (H1N1) 2009 virus prompted the World Health Organization (WHO), on 11 June 2009,~     to declare the first influenza pandemic in 41 years. In Taiwan, a clinical study to assess~     the immunogenicity and safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in healthy~     volunteers has already been completed. In the previous study, we found that a single 15 mcg~     HA dose of the AdimFlu-S (A/H1N1) vaccine induces a protective immune response in most~     adults, including those > 60 years of age (>70%). Our current study aims to follow-up~     subjects who received Influenza Virus Vaccine, AdimFlu-S (A/H1N1), six months ago. These~     subjects' serum samples were tested for anti-hemagglutinin (HA) antibodies by~     hemagglutination inhibition (HAI). The seroconversion is defined as the post-vaccination~     serum HAI titer had at least 1:40 for subjects who had seronegative pre-vaccination or a~     four-fold or greater increase in HAI titers for subjects who had seropositive pre-vaccination~     serum. The immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in adults after~     half a year will be analyzed and discussed among the subjects with serum HAI titer had at~     least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection.~   "
188571|NCT01096225|"~     The primary immunogenicity objective is to assess the antibody response and T-cell response~     of split-virion inactivated A (H1N1) vaccine. Participants will include up to 20 healthy~     persons of age 20 and older who have no history of novel influenza H1N1 2009 infection in~     latest 3 months or novel influenza H1N1 2009 vaccination. This is a randomized study in~     healthy males and non-pregnant females, aged 20 years and older. All subjects will be~     stratified into 1 dose group (15mcg per dose), and will receive intramuscular influenza H1N1~     vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. On Day 0, Day 10, Day 21,~     Day 28, Day 35 and Day 42 after first vaccination (Day 0), the immunogenicity testing will be~     manipulated. The antibody response of immunogenicity testing will be hemagglutination~     inhibiting (HAI) on serum. The T-cell response will be interferon-gamma ELISPOT assay and~     Tetramer staining using PBMCs.~   "
188572|NCT01096212|"~     Sevoflurane is currently being used in more than 100 countries worldwide with an estimated~     100 million operations having been performed using sevoflurane as a general anesthetic. After~     the expiry of the patent on sevoflurane as a pharmaceutical drug, a generic product~     (Sevofran®; Hana pharmacy, Co. Ltd, Seoul, Korea) has been launched. The aims of this study~     were to investigate the efficacy (mean minimum alveolar concentration), recovery~     characteristics (time to recovery of consciousness (ROC) and recovery, and BIS values at ROC~     and orientation), and safety (incidence and severity of adverse events) of generic~     sevoflurane in patients undergoing elective surgery.~   "
188573|NCT01096199|"~     Hypothesis: The addition of RAD001 to TS-1/CDDP is safe and can improved the efficacy of~     TS-1/CDDP. The rationale for combining RAD001 with TS-1/CDDP are:~        1. Potential synergism for the combination TS-1/CDDP Activation of the PI3K/AKT/mTOR~          pathway is frequently a characteristic of worsening prognoses (through increased~          aggressiveness), resistance to treatment, extension of disease and progression. The~          antitumour effect of RAD001 is mediated through the antiproliferative and antiangiogenic~          activity of mTOR inhibition. In preclinical study, RAD001 demonstrated synergism with~          CDDP in several cancer types including lung (A549; CI 0.47), epidermoid cancer (KB-31;~          CI 0.74), colon cancer (HCT116; CI 0.47) and gastric cancer (SNU 1; CI 0.204, SNU 216;~          CI 0.546, SNU 638; CI 0.039, SNU 668; CI 0.396) (IB, Lee 2008 AACR).~        2. Potential for overcoming TS-1/CDDP resistance. Upregulation of Akt pathway was found to~          be an important mechanism for acquired resistance to CDDP (Lee 2005 Gyn Onc, Liu 2007~          Cancer Res). In addition, gastric cancers with upregulated Akt pathway are associate~          with primary resistance to 5- fluorouracil, adriamycin, mitomycin C, and cisplatin (Oki~          2007 PASCO)~        3. Overlapping antitumour activities with TS-1/CDDP RAD001 is effective and well tolerated~          against subcutaneous tumours established from a variety of tumour cell lines of diverse~          histotypes (NSCLC, pancreatic, gastric, colon, renal, melanoma, epidermoid), including a~          Pgp170-overexpressing, multi-drug resistant tumor line. Partial response to single agent~          RAD001 was seen in a patient with gastric cancer at the dose of 5mg/day and 2 patients~          (gastric and oesophageal cancer) at the dose of 10mg/day, in study C2101 and C1101~          respectively. A clinical benefit (stable disease, partial response and complete~          response) was observed in 55% of patient with gastric cancer who had failed 1st line~          therapy (Yamada 2009 GCS ASCO). A phase III study of RAD001 in patients with 2nd/3rd~          line gastric cancer has currently opened for recruitment.~   "
188574|NCT01096186|"~     The purpose of this study is to determine the long term safety and clinical utility of IPX066~     in subjects with Parkinson's Disease.~   "
188575|NCT01096173|"~     This study is intended to be an evaluation of the properties of human sputum collected from~     patients with COPD. It is hypothesized that cationic airway lining modulators will have~     beneficial effects on the rheological properties of sputum derived from patients with COPD.~     Approximately 10 patients with COPD will collect sputum at home for 5 days. Samples will be~     collected and tested in laboratory tests.~   "
188576|NCT01096160|"~     This study will evaluate the safety and tolerability of MK8266.~   "
188577|NCT01096147|"~     Spinal cord stimulation (SCS) has been used for over 40 years to treat neuropathic pain.~     Various clinical studies have shown a beneficial effect of SCS on pain in patients with~     Failed Back Surgery Syndrome (FBSS). Since more than 2 years the 8-contact points Octad lead~     has been used and replaced the 4-contact points Quad lead. Even though it seems that eight~     electrodes has potential advantage over the four electrodes in case of lead migration or~     disease progress, no clinical data have been published on the effectiveness of SCS using the~     octopolar epidural lead. The Octad study intents to assess the effectiveness and technical~     performance of SCS with the Octad® lead for treatment of chronic pain. This study is not set~     up as a comparison study between the Octad lead and other SCS leads, such as the Quad lead,~     because the Octad lead is used in most eligible FBSS patients as the standard of care lead.~      The study intends to:~        1. evaluate the effectiveness of SCS with the Octad® lead on chronic pain in Failed Back~          Surgery Syndrome patients after 12 months of treatment.~        2. collect safety data for SCS with the Octad® lead in patients with refractory chronic~          pain.~   "
188578|NCT01096134|"~     The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a~     strategy to deliver comprehensive cervical cancer prevention services in Thailand and the~     Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful~     screening and treatment programs for mothers.~   "
188580|NCT01096108|"~     Standard Quit and Win contests, in which smokers typically quit for one month in return for~     the opportunity to win prizes, are simple and easy to implement and may be cost-effective in~     encouraging smokers to quit. By extending contest length and enhancing counseling content,~     Quit and Win contests may be more effective at encouraging smoking abstinence.~      This study aims to evaluate the efficacy of extended and content-enhanced Quit and Win~     contests to enhance smoking abstinence at college campuses.~   "
188581|NCT01096095|"~     DESIGN: Pilot, Phase II, double-blind, placebo-controlled study~      JUSTIFICATION: In the literature one does not find a pharmacological treatment that changes~     the natural history of Spinocerebellar ataxtia type 3 (SCA3). Patients with this disease~     invariably become dependent.~      OBJECTIVES I. To determine safety and tolerability of phenylbutyrate in patients with SCA3.~      II. To provide early subsidies on the efficacy of phenylbutyrate in SCA3.~      DURATION: 12 months of a double-blind study.~      PLACE OF REALIZATION: Hospital de Clínicas de Porto Alegre, Brazil.~      NUMBER OF PATIENTS: 20 patients.~      CONCOMITANT MEDICATIONS: There are no concomitant medications that are prohibited unless they~     affect safety parameters of this study (hemogram and platelets; fasting serum glucose, AST,~     ALT, Gamma-GT, Bilirubins, Prothrombin time, Creatinine, Urea, Na, K, chlorides and arterial~     gasometry; electrocardiogram and echocardiogram).~      MEDICATIONS UNDER INVESTIGATION: Powdered sodium phenylbutyrate in sachets containing each~     3g. At the start of the study, the dose will be 15g/day (five sachets) and may be reduced in~     case of mild adverse events.~      OUTCOMES Primary safety outcome: The number of adverse events, interruptions and dose~     reductions in the two groups (cases and controls).~      Efficacy outcomes: Efficacy outcomes are the following scores in both groups: NESSCA, SARA,~     Barthel, BDI, and WHOQol.~   "
188582|NCT01096082|"~     Design: Phase II-III, double-blind, parallel, placebo controlled randomized Clinical trial~      Background: Spinocerebellar ataxia type 3 (SCA-3) is an autosomal dominant adult-onset~     neurodegenerative disorder for which there is no current treatment. Patients will invariably~     become dependent from others and unable to walk during the disease course.~      Hypothesis: Lithium Carbonate is safe and effective in treating neurological symptoms and~     improving quality of life of patients with SCA3.~      Outcomes:~      Primary~        -  Phase 2 - To assess safety and tolerability of Lithium Carbonate in patients with SCA3~          after 6 months of follow-up~        -  Phase 3 (if Phase II study shows safety of therapy) - To assess efficacy of Lithium~          Carbonate in patients with SCA3 through the Neurological Examination Score for SCA 3~          (NESSCA) after 12 months of follow-up .~      Secondary~        1. - To assess efficacy on neurological function, ataxic, depressive and quality of life~          scores of Lithium Carbonate in patients with SCA3 through the Scale for the Assessment~          and Rating of Ataxia (SARA), 9-Hole Peg Board test, 8m walking time, PATA repetition~          rate, Click Test, SCA Functional Index (SCAFI), Composite Cerebellar Functional Score~          (CCFS), Beck Depression Inventory, Barthel Index and WHOQol after 6 and 12 months of~          follow-up.~        2. - To assess the effect of Lithium Carbonate in peripheral levels and expression of~          treatment biomarkers (BDNF, NSE, HDAC, GSK-3Beta)~      Study Duration: 12 months~        -  Final analysis of phase 2 (safety study) at 6 months with continuous monitoring until~          the end of phase 3 (efficacy study).~        -  Preliminary analysis of efficacy on ataxia scales at 6 months of study and final~          analysis of phase 3 at 12 months.~      Obs: A futility analysis will be performed after 12 months of therapy if no statistically~     significant difference between groups were found. This analysis will define if the study will~     continue until 18 or 24 months of follow-up or will be ended at 12 months.~      Location: Hospital de Clínicas de Porto Alegre~      Subjects: 60 molecularly diagnosed SCA3 patients from the outpatient unit of the Medical~     Genetics Service of Hospital de Clínicas de Porto Alegre~      Intervention: Lithium Carbonate tablets of 300mg. Starting dose will be 300mg/day with drug~     titration during 49 days or until achieving the defined target lithium serum level of 0.5 to~     0.8 mEq/L~   "
188583|NCT01096069|"~     There is a correlation between the CD55, CD59, CD35 and CD46 expression on B lymphocytes of~     patients before and after treatment with rituximab and the level of depletion and~     repopulation time for these cells. The theoretical rationale of the study assumes that the~     correlation, if any, will be a negative correlation. However, the hypothesis of positive~     correlation (two-tailed test) will also be tested.~   "
188584|NCT01096056|"~     The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline~     Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age.~      This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The~     impacted sections are study design, outcome measures, intervention sections and number of~     subjects.~   "
188585|NCT01096043|"~     Study CXL-1020-02 employs is designed to further define suitable clinical dosages for~     CXL-1020 which will be utilized in a later Phase IIb study. The study is conducted in 3~     different stages called 'strata and evaluates the potential utility of this drug for the~     treatment of patents who are hospitalized with heart failure.~   "
188586|NCT01096030|"~     This will be an uncontrolled, open-label, non-randomized, phase I study. The primary~     objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety~     and tolerability of Regorafenib administered orally as a single agent in Chinese patients~     with advanced solid tumors. The secondary objectives are to evaluate tumor response of~     patients treated with Regorafenib.~   "
188587|NCT01096017|"~     This is a single blind, single dose, crossover study to investigate the relative efficacy of~     terbutaline Turbuhaler® 0.4 mg in relation to salbutamol pressurized Metered Dose Inhaler~     (pMDI) 200 μg in Japanese adult asthmatic patients.The secondary objective of this study is~     to investigate safety of terbutaline Turbuhaler® 0.4 mg in Japanese adult asthma patients by~     means of adverse events (AEs) and vital signs (blood pressure, pulse rate). The subject~     population includes Japanese patients (16 years of age or older) with asthma who need~     treatment with inhaled Glucocorticosteroids (ICS).~   "
188588|NCT01096004|"~     The primary purpose of this study is to investigate different methods to evaluate the effect~     of AZD4017 in adipose tissue after single and multiple doses of AZD4017 in abdominally obese~     but otherwise healthy subjects.~   "
188589|NCT01095991|"~     The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin~     pharmacokinetics and vice versa in patients with Type 2 Diabetes Mellitus.~   "
188590|NCT01095978|"~     To describe the relief of symptoms, tolerability, and compliance of treatment with Klacid®~     sustained release (SR) at a dose of 1000 mg once daily in patients with acute tracheitis,~     acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic~     bronchitis or mild community-acquired pneumonia.~      This postmarketing observational study is non-interventional and is being conducted in a~     prospective, single-arm, single-country, multicenter format.~      Klacid SR will be prescribed in usual manner in accordance with the terms of the local market~     authorization with regards to dose, population, and indication as well as with local~     guidelines.~   "
188604|NCT01095796|"~     To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing~     fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir~     disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected,~     antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who~     are not candidates for non-nucleoside reverse transcriptor-based STRs.~   "
188605|NCT01095783|"~     The purpose of this study is to determine whether a physiotherapeutic intervention is~     effective in the treatment of low back pain in hemodialysis patients~   "
190153|NCT01075490|"~     This prospective, double blinded study investigates spinal anesthesia with or without~     clonidine added to bupivacaine in newborns. This study is based on duration measurement of~     spinal anesthesia and cardio respiratory recording during 24h for apnea detection.~   "
188591|NCT01095965|"~     The purpose of this study is to implement a nutrition education programme that was developed~     for type 2 diabetic adults in a resource poor setting and to evaluate the programme's~     effectiveness on health outcomes~      A randomized controlled clinical trial study design will be used. One group (experimental~     group) will receive the nutrition education while the other group (control group) will~     receive the usual care.~      Setting: Two Community health centres in Moretele Health Sub-District, North West Province,~     South, Africa~      Effectiveness of the nutrition education will be evaluated for the following outcomes:~        -  clinical~             -  blood sugar control based on HbA1c levels (primary outcome)~             -  lipid profile (total cholesterol, low density cholesterol, high density cholesterol~               and triglycerides)~             -  blood pressure~             -  body mass index~        -  dietary intake~        -  others -diabetes knowledge, attitudes towards diabetes~      Outcome measurements- at six and 12 months, this will be compared with the baseline data.~      Hypotheses:~        -  the experimental group will have a significantly lower HbA1c compared to the control~          group~        -  the experimental group will have significantly better outcomes for dietary intake, blood~          lipid profile, blood pressure, body mass index, diabetes knowledge and attitudes towards~          diabetes and its treatment.~   "
188592|NCT01095952|"~     The aim of this multi-center research study is to evaluate the performance (primary purpose)~     and safety of a new algorithm aimed at controlling ventricular rate (VR) during rapidly~     conducted atrial fibrillation (AF) by delivering AV node stimulation (AVNS) from the atrial~     lead placed at a septal position, and designed with the purpose of reducing inappropriate~     shocks. Additional purposes include the assessment of a possible application of AVNS aimed at~     allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of~     implantation data on selective placement of the atrial lead in postero-septal right atrium.~     About 37 patients will be followed for half a year.~   "
188593|NCT01095939|"~     The purpose of the Post-preeclampsia Renal Project is to investigate the renal function of~     preeclamptic women after delivery, and to determine whether the anti-hypertensive drug named~     benazepril efficiently improves the dysfunctions observed.~   "
188594|NCT01095926|"~     Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the~     predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity~     .~   "
188595|NCT01095913|"~     The goal of this clinical research study is to find lymph nodes before surgery using a dye~     called indocyanine green (IC-Green).~      Objectives:~        1. To determine the feasibility of using nonradioactive optical imaging techniques with~          indocyanine green (ICG) as a fluorescent contrast agent to identify all axillary lymph~          nodes.~        2. To determine the feasibility of using nonradioactive optical imaging techniques with ICG~          as a fluorescent contrast agent to characterize lymphatic architecture and function in~          women with breast cancer who are scheduled for axillary node dissection.~   "
188596|NCT01095900|"~     Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing~     temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to~     compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in~     patients with uncomplicated chronic anal fissure.~   "
188597|NCT01095887|"~     The purpose of this study is to try to determine if the drug eculizumab can help prevent~     antibody-mediated rejection in patients undergoing a kidney transplant from a living donor~     with a different blood type than their own.~   "
188598|NCT01095874|"~     The purpose of this study is to compare outcome of high risk myelodysplasia patients aged~     from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk~     myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever~     thrombocytopenia. Patients are registered when they acquire risk factors.~   "
188599|NCT01095861|"~     Patients presenting for elective surgery requiring tracheal intubation will be randomized to~     one of two different endotracheal tubes (ETT).~   "
188600|NCT01095848|"~     To determine the safety and immunogenicity profile of two (2) different doses of the vaccine~     DPX-0907 to treat breast, ovarian and prostate cancer.~   "
188601|NCT01095835|"~     This study will compare the efficacy and safety of 2 different durations of treatment with~     pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen~     (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a~     treatment alone and in combination with lamivudine (LAM). The anticipated time on study~     treatment is 1-2 years, and the target sample size is 100-500 individuals.~   "
188602|NCT01095822|"~     People with both hypertension and diabetes have a higher chance of developing heart and~     arterial problems that could be reduced with anti-coagulant therapy. Valsartan (Diovan), an~     FDA approved angiotensin-II receptor antagonist (blocker) clinically indicated for the~     treatment of essential hypertension is known to inhibit platelet activity in both an in vitro~     and ex vivo setting. Aliskiren (Tekturna) is a recently FDA-approved potent direct renin~     inhibitor which is also an effective anti-hypertensive agent in patients with~     mild-to-moderate hypertension and which, in vitro, modulates antithrombin III in plasma.~     Therefore, in addition to being clinically approved anti-hypertensive medications, combining~     these two agents will potentially target both primary hemostasis (platelets) and~     anticoagulant (antithrombin-III is a cornerstone substrate for heparin) properties to exert~     their anti-thrombotic efficacy simultaneously. This combination strategy may not only improve~     hypertension management, but also improve vascular outcomes in high-risk diabetic population~     via favorable effects on anti-thrombotic activity. Importantly, there have been no~     significant additional safety concerns of using the combination of aliskiren and valsartan.~     The investigators hypothesis is that valsartan 160 mg/daily in combination with aliskiren~     150-300 mg/daily for 4 weeks will favorably affect blood levels of~     platelet/coagulation/fibrinolytic biomarkers (ie, diminish platelet activity, and enhance~     antithrombin III potency) when compared with monotherapy with aliskiren 150mg/daily in~     hypertensive patients with type 2 diabetes mellitus.~   "
188603|NCT01095809|"~     The purpose of this study is to determine whether intravitreous bevacizumab or intravitreous~     triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema~   "
188619|NCT01095601|"~     This study will assess the effect of food on the pharmacokinetics of avanafil (Formulation~     II); determine the relative bioavailability of two avanafil tablet formulations (Formulation~     I versus Formulation II) and will investigate the dose-proportionality of Formulation II~     avanafil tablet.~   "
188606|NCT01095770|"~     The purpose of this study is 3 fold:-~        1. To compare the efficacy and complication rates of 2 widely used methods, conventional~          irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of~          AF ablation for PAF.~        2. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared~          to the 'gold standard' DDD pacemaker Holter.~        3. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF~          ablation therapy for PAF.~   "
188607|NCT01095757|"~     The purpose of this study is to test whether the addition of the drug plerixafor to treatment~     with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the~     chances of transplant. The study will look for the activation of a certain type of blood~     cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The~     investigators will follow the number of patients that achieve the target numbers of CD34+~     cells. The number of patients achieving the target level of CD34+ cells, and the total number~     of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy~     and G-CSF, without plerixafor.~      The investigators will also test the safety of the combination of plerixafor with~     chemotherapy and G-CSF and look at the success of the transplantation after 12 months.~   "
188608|NCT01095744|"~     The first objective is to asses influence of age on amyloid load measured by PET imaging~     using Pittsburgh B compound (PiB) radio-tracer, in Alzheimer's disease(AD). This will allow~     the determination of brains age-specific deterioration factors by comparing Early onset AD~     (EOAD), Late onset AD (LOAD)and atypical focal cortical AD (PCA and LPA). The amount of brain~     lesions in AD patients is estimated by:~        1. measuring the rate of cortical brain atrophy,~        2. FDG imaging of glucose metabolism reflecting neuronal activity, and~        3. for patients who benefited from a lumbar puncture; Cortical-spinal fluid (CSF) amounts~          of amyloïd and tau proteins are measured.~   "
188609|NCT01095731|"~     The purpose of this phase II study is to further assess the safety of tiopronin in aneurysmal~     subarachnoid hemorrhage(aSAH) patients in order to obtain preliminary data on the efficacy of~     tiopronin versus placebo in reducing serum and cerebrospinal fluid (CSF) 3AP levels in this~     patient population.~      Funding Source - FDA Office of Orphan Products Development~   "
188610|NCT01095718|"~     This study is a comparison of 3 learning techniques, Errorless learning, modelling and trial~     and error, in the relearning of IADL of Alzheimer patients from mild to moderately severe~     dementia.~      Tailored IADL will be chosen for each patient (n=300) and trained in individualized sessions~     for 6 weeks.~      This study focuses on the relationship between learning techniques, IADL and memory~     processes, in a threefold way:~        1. it will determine which of the of the three learning techniques (EL, MR, TE) will~          improve most the (re)learning of instrumental skills in different dementia stages using~          a randomized controlled trial;~        2. it will explain the role of implicit and explicit memory mechanisms in the (re)learning~          of IADL tasks; and~        3. as a secondary objective, it will explore the possible drug treatment by behavioral~          intervention interaction effects of the three learning techniques.~   "
188611|NCT01095705|"~     The purpose of this study is to determine the additive value of hypnosis to improve patient~     comfort during transesophageal echocardiography (TEE).~   "
188612|NCT01095692|"~     Nowadays the clinical significance of an occult stress urinary incontinence and its optimal~     treatment is not known.Regarding treatment, there are 2 main approaches : either the~     systematic preventive treatment of the occult stress urinary incontinence by means of a~     tension free vaginal tape (TOT) together with the treatment of prolapse or the treatment of~     prolapse in the first place and treatment of stress incontinence in a second time when and if~     it appears.This study is expected to provide objective evidence concerning the efficacy and~     security of TOT implantation for the prevention treatment of occult stress urinary~     incontinence in women with pelvic organ prolapse and occult urinary incontinence.The~     perspective is to improve the management of these patients by providing evidence based~     recommendation for their treatment.~   "
188613|NCT01095679|"~     Periodic ventilation that includes CHEYNE Stokes ventilation is a pathological pattern~     characterized by alternating periods of hyperpneas and apnea-hypopneas. It occurs generally~     during sleep, at high altitude and in hypoxic conditions in healthy subjects, and in some~     diseases like congestive heart failure. One study conducted on an animal model suggested that~     baclofen, a drug already used against spasticity in humans, could also be effective against~     periodic ventilation. The goal of the study is therefore to assess this hypothesis on~     hypoxia-induced periodic ventilation in healthy subjects during sleep.~   "
188614|NCT01095666|"~     The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can~     help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well~     controlled on metformin alone. The safety of this treatment will also be studied.~   "
188615|NCT01095653|"~     The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can~     improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never~     been treated with medication or have been on medication for less than 24 weeks since their~     original diagnosis of Diabetes. The safety of this treatment will also be studied.~   "
188616|NCT01095640|"~     Marketed by Galderma Laboratories, L.P., Differin® (adapalene 0.3% topical gel) is a safe and~     effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC~     has developed a generic formulation of adapalene 0.3% topical gel and the current study is~     designed to evaluate the safety and efficacy of this formulation.~   "
188617|NCT01095627|"~     This study is aiming at evaluating whether the number and size of exhaled particles changes~     during the increase and decrease of bronchial constriction in subjects with mild intermittent~     asthma.~   "
188618|NCT01095614|"~     Women sexual hormones (i.e. estrogen) are involved in the regulation of substrate utilization~     and storage. Being under oral contraception (OC) may conduct to metabolic and hormonal~     modifications, but results are confused regarding the impact on substrate utilization. In the~     present study, the aim is then to explore the effect of hormonal status on substrate~     utilization during sous-maximal exercise, comparing women with and without OC.~      We hypothesised that women under OC have a lower Respiratory Exchange Ratio (RER) at exercise~     than women without contraception underlying a greater reliance on fat oxidation.~   "
188621|NCT01095575|"~     Background and Objectives: Neuraxial administration of morphine is an effective way of~     controlling postoperative pain and reducing analgesic consumption. Several animal models have~     demonstrated that preemptive administration of neuraxial narcotics reduced pain while others~     revealed the induction of post-incisional hypersensitivity. There have been no consistent~     results in clinical setting either. This double blind, randomized study compared the effects~     of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain~     perception and analgesic requirements over 48 hours following laparotomy for open colectomy~     under standardized general anesthesia.~      Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after~     wound closure (MO1 group), and 20 patients received epidural saline before incision and~     morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of~     morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of~     intramuscular diclofenac (75 mg) every 6 hours, as needed.~   "
188622|NCT01095562|"~     This is an efficacy and safety study evaluating an experimental treatment for cognitive~     deficits in adults with schizophrenia.~   "
188623|NCT01095549|"~     The prevalence of peripheral artery disease (PAD) defined as ankle-brachial index (ABI) less~     than 0.9 was about 15~30% in patients with end stage renal disease (ESRD), which was higher~     than those with normal renal function. A lower ABI and a higher brachial-ankle pulse wave~     velocity (baPWV) are good markers to predict the risk of PAD and atherosclerosis~     respectively. In addition, baPWV>2,100 cm/s was shown to be related to potential PAD. ABI~     <0.9 was positively associated with vascular access failure in hemodialysis (HD) patients and~     our previous study has demonstrated that far infrared (FIR) therapy can improve access flow~     and unassisted patency of atrioventricular (AV) fistula.~      The aims of this study are to evaluate (1) the frequency of and (2) risk factors associated~     with abnormal ABI and PWV as well as (3) the effect of FIR on ABI and PWV and markers related~     to endothelial dysfunction in HD patients.~   "
188624|NCT01095536|"~     Risk factors for postoperative shoulder pain after laparoscopic cholecystectomy were not~     clear. Moreover, risk factors for postoperative emesis specially for this surgery were not~     detailed and accurate. The present study is a prospective cohort study to identify risk~     factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic~     cholecystectomy under general anesthesia.~   "
188625|NCT01095523|"~     Background:~        -  Survival rates for colorectal cancer depend on a number of factors, including the~          existence of tumors outside the colon and rectum. Patients who had tumors elsewhere in~          the abdomen (such as in the peritoneum or ovaries) when they were diagnosed, as well as~          patients who had bleeding or obstruction when they were diagnosed, have a high risk of~          cancer recurrence even after surgery or other treatment.~        -  If additional tumors are discovered early and removed while they are still small (often~          before they can show up on scans), survival rates may improve. In addition, patients who~          receive a heated chemotherapy solution delivered directly to the abdomen often have~          better treatment outcomes regardless of whether additional tumors were found. Further~          research can help determine the usefulness of both of these treatments in improving the~          outcomes of patients with colorectal cancer.~      Objectives:~      - To determine whether patients who have had surgery for colorectal cancer have improved~     outcomes after receiving additional surgery combined with direct chemotherapy, compared with~     those who receive the current standard of care.~      Eligibility:~      - Individuals at least 18 years of age who have had surgery for colorectal cancer within the~     past 14 months, who are considered to be at high risk for cancer recurrence, and whose~     current imaging scans show no signs of additional tumors.~      Design:~        -  Participants will be divided into two treatment groups: a surgery group and a standard~          of care group.~        -  Participants who had surgery less than 11 months ago will be enrolled in a 3-month~          lead-in phase to receive standard follow-up care, including labs, scans, and physical~          examinations, before being randomized to a treatment group between 11 and 14 months~          after surgery. Participants who had surgery between 11 and 14 months ago will be~          randomized at the time of enrollment.~        -  Participants in the surgery group will have the following procedures within 2 weeks of~          randomization:~        -  Abdominal surgery where surgeons will look for and remove any tumors and take biopsies~          to check for cancer cells~        -  Heated chemotherapy, with three chemotherapy drugs administered directly to the abdomen~        -  In-patient recovery and follow-up visits beginning 3 to 6 weeks after discharge.~        -  Participants in the standard of care group will have the standard follow-up schedule for~          high-risk colorectal cancer patients:~        -  Clinic evaluations every 3 months for 2 years, and then every 6 months for 3 years and~          yearly thereafter....~   "
188626|NCT01095510|"~     The objectives of this study were to evaluate: (1) the dose response and (2) the~     pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE~     for the treatment of acute angioedema attacks in children above and below 25 kg and less than~     12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and~     tolerability following IV administration of CINRYZE in this study population.~   "
188627|NCT01095497|"~     The objectives of the study are to:~        1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection~          in subjects with hereditary angioedema~        2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by~          subcutaneous injection~        3. Assess the immunogenicity of CINRYZE following subcutaneous administration~   "
188628|NCT01095484|"~     The named patient program will allow investigators to supply rotigotine transdermal system to~     patients who have a documented medical necessity to receive treatment with the drug.~   "
188629|NCT01095471|"~     This is a follow-on, multi-centre, open-label, clinical trial. The purpose of this trial is~     to investigate the concentrations of serotype-specific antibodies to IgG included in PCV13 in~     children who have received either the PCV7 or PCV13 primary immunisation at 2, 4 and 12~     months of age. We intend to recruit all interested participants who completed the~     Wyeth-sponsored PCV13 infant trial study (6096A1-007) at selected study sites (i.e. those~     that recruited the majority of the children in the original study). The study will start in~     March 2010, at which time the eldest participants in the 6096A1-007 study will be~     approximately 42 months of age. There will be two visits per participant, 1 month apart from~     each other. At visit one, all participants will have a blood test and receive a dose of~     PCV13. At visit 2, all participants will have a blood test and will be offered the remaining~     pre-school booster vaccinations unless they have already received them.~   "
188640|NCT01095328|"~     Q fever in the Netherlands is becoming more common. A Q fever infection is a serious threat~     to certain risk groups,including pregnant women. Pregnant women are more often than the~     general population asymptomatic. Studies from France show that an infection with Coxiella~     burnetii may cause obstetric complications including spontaneous abortion, intrauterine fetal~     death, intrauterine growth retardation and oligohydramnios.~      The aim of this study is to assess the effectiveness and cost effectiveness of a~     multidisciplinary screening program, whereby pregnant women in first line healthcare in~     high-risk areas for Q fever are screened with a single blood sample during pregnancy. If~     found positive for Q fever, advise for antibiotic treatment will follow as part of regular~     healthcare. Treatment is therefore not part of the study protocol.~      The results of this study will give more insights in the risks of asymptomatic Q fever in~     pregnancy and the benefits and harms of a screening strategy during pregnancy. This study~     will be used to give an evidence based advice to the Dutch minister of health on screening~     for Q fever in pregnancy.~   "
188630|NCT01095458|"~     Weight loss and maintenance continues to be problematic for individuals who are overweight or~     obese. State-of-the-art treatment generally involves a behavioral weight loss clinic that~     emphasizes nutrition, physical activity, and lifestyle changes and is delivered face-to-face~     between health educators and small groups of participants. This delivery system is time~     consuming, expensive, and presents numerous barriers to the participant. We have developed a~     phone based delivery system that eliminates many of these barriers by substituting group~     conference calls for clinics and by delivering weight loss materials and products directly to~     the participant.~      Hypothesis 1: We expect equivalent weight loss from baseline for phone and clinic groups and~     have defined equivalence as no greater than 4 kg difference between groups based on our pilot~     data and potential for clinical significance.~      Hypothesis 2: During weight maintenance it is likely that participants will experience some~     weight re-gain. We expect both phone and clinic groups to re-gain a similar amount of weight~     and that weight for both groups at 18 months will be significantly less than baseline~     weights.~      Hypothesis 3: We will complete a cost analysis to determine which delivery method is more~     economical. Specifically, we expect the phone delivery system to be more cost effective than~     that of the in-person clinics.~   "
188631|NCT01095445|"~     The purpose of this study is to evaluate the effect of 48 vs 24 weeks of treatment with~     Peginterferon alfa-2b plus weight-based ribavirin on Sustained Virologic Response (SVR) and~     relapse rates in patients infected with genotype 3 chronic hepatitis C (CHC) who do not~     achieve a Rapid Virologic Response (RVR) but attain a complete Early Virologic Response~     (cEVR).~   "
188632|NCT01095432|"~     The purpose of this study is to study samples of rectal mucosa (the moist lining of the~     rectum) using a new light scattering technology, called partial wave spectroscopy (PWS) in~     patients who will undergo a standard of care colonoscopy or a flexible sigmoidoscopy and have~     a history of ulcerative colitis (UC).~   "
188633|NCT01095419|"~     The purpose of this study is to evaluate the effects of Massage Therapy for improving the~     quality of sleep in patients on postoperative period of coronary artery bypass graft surgery~     (CABG).~   "
188634|NCT01095406|"~     The present protocol will demonstrate the safety, feasibility and efficacy of a newly~     computerized protocol integrated into a ventilator: S1 ventilator (Hamilton Medical). During~     ventilation with S1 ventilator, the respiratory support including oxygenation and CO2 removal~     parameters are continuously adapted to patient respiratory status using science based rules.~     The present protocol is designed as a pilot evaluative study where the researchers will~     evaluate the safety, feasibility and efficacy of ventilating children during the weaning~     phase with the S1 ventilator for 5 hours, and compare to conventional ventilation.~   "
188635|NCT01095393|"~     Observational registry to assess the longer-term risk of serious infections and malignancies~     reported with TNFα-blocker therapy, as well as the longer-term risk of cardiovascular and~     thromboembolic events in adult Rheumatoid Arthritis (RA) patients treated with Cimzia® as~     compared to non-biologic DMARD-treated controls.~   "
188636|NCT01095380|"~     Background: Body weight supported (BWS) locomotor training improves overground walking~     ability in individuals with motor-incomplete spinal cord injury (SCI). While there are~     various approaches available for locomotor training, there is no consensus regarding which of~     these is optimal. The purpose of this ongoing investigation is to compare outcomes associated~     with these different training approaches.~      Subjects and Methods: Subjects with chronic motor-incomplete SCI have completed training and~     initial and final testing. Subjects were randomly assigned to 1 of 4 different BWS~     assisted-stepping groups, including: 1) treadmill training with manual assistance (TM), 2)~     treadmill training with stimulation (TS), 3) overground training with stimulation (OG), or 4)~     treadmill training with robotic assistance (LR). Prior to and following participation the~     investigators assessed:~        -  Walking-related outcome measures: overground walking speed, training speed, step length~          and step symmetry.~        -  Spinal cord reflex activity~        -  Electromyographic (EMG) associated with walking~      Hypotheses:~      In individuals with incomplete spinal cord injury (SCI):~        1. A 12-week period of body weight supported treadmill training with TS will produce~          improvements in walking function that are significantly greater than those produced by~          training with TM, OG, LR.~        2. TS training will be associated with greater changes to spinal reflex activity than will~          be observed in subjects trained with manual assistance or non-assisted stepping. Changes~          to spinal reflex activation will be such that this activity more closely resembles that~          observed in non-disabled (ND) individuals.~        3. Following participation in this walking regimen, EMG activity observed during walking in~          all groups will be more robust, more consistent and better coordinated than EMG measures~          obtained prior to training.~   "
188637|NCT01095367|"~     The purpose of this research is to determine if a film to prevent adhesions will improve the~     area of distribution of a contrast dye (representative of chemotherapy) in the abdominal~     cavity (belly) of women who have undergone surgery for ovarian cancer as compared with~     patients who have not had adhesion barrier sheets placed in the belly. It is believed that~     this film, Seprafilm™, reduces adhesions (scar tissue between tissues and organs) in the~     abdominal cavity following surgery. Adhesions can limit the distribution of the chemotherapy~     agent placed in the abdomen to treat the ovarian cancer. Thirty subjects will receive~     adhesion barrier sheets and thirty will not. To determine if the sheets prevent adhesions,~     all subjects will have a dye inserted into the abdomen and then have X-rays of the abdomen to~     look at the distribution of the dye between the two groups.~      Hypothesis:~      Null hypothesis: There is no difference in area of distribution of the intraperitoneal dye in~     the Seprafilm ™ vs. no Seprafilm™ groups.~      Alternative hypothesis: Seprafilm™ reduces adhesion formation and there is a larger area of~     distribution of intraperitoneal dye in the Seprafilm™ group.~   "
188638|NCT01095354|"~     The primary objective of this study is to determine if well-controlled asthmatic patients~     followed in subspecialty asthma clinics between the ages of 3 - 18 years can be distinguished~     from healthy controls using lung clearance index, a parameter from the multiple breath~     washout test. Also, to correlate lung clearance index with asthma sputum cell counts.~   "
188639|NCT01095341|"~     The purpose of this study is to evaluate the frequency and the clinical course of~     postoperative hyperthyroidism following surgery of tertiary hyperparathyroidism (THP) and to~     determine the diagnostic value of thyroglobulin in this setting.~   "
188641|NCT01095315|"~     Maternal hypotension is a common problem during cesarian section under spinal anesthesia. The~     possible explanation for this is combined aortocaval compression by gravid uterus in~     parturient in addition to reduced systemic vascular resistance by spinal anesthesia. The~     investigators evaluated if the incidence of hypotension would be decreased by delayed supine~     positioning, by maintaining lateral position for 6 min after spinal injection, in patients~     undergoing elective cesarean section.~   "
188738|NCT01094054|"~     The overall aim is to determine the mechanism(s) by which common bariatric surgical~     procedures alter carbohydrate metabolism. Understanding these mechanisms may ultimately lead~     to the development of novel interventions for the prevention and treatment of Type 2 diabetes~     and obesity.~   "
188642|NCT01095302|"~     Primary Objective:~        -  To determine the maximum tolerated dose based on the incidence of dose limiting toxicity~          and the maximum administered dose of ombrabulin in combination with docetaxel and~          cisplatin administered every 3 weeks in patients with advanced solid tumors~      Secondary Objectives:~        -  To assess the overall safety profile of the combination therapy~        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR~          258063, docetaxel and cisplatin in combination.~        -  To evaluate anti-tumor activity of the combination therapy~   "
188643|NCT01095289|"~     The objective of this study is to evaluate the electromyographic activity of masseter muscle~     during deglutition in laryngectomized subjects.~   "
188644|NCT01095276|"~     The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line~     nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients~     receiving mechanical ventilation.~   "
188645|NCT01095263|"~     The investigators will investigate in a sham controlled design antidepressant effects and~     safety of DBS to the superolateral branch of the main medial forebrain bundle (slMFB).~   "
188646|NCT01095250|"~     This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the~     treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic~     immunosuppression.~   "
188647|NCT01095237|"~     This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm~     Diameter) as superficial femoral artery bypass/interponate.~      The aim of this study is to demonstrate safety of implantation, patency and durability of a~     new type of vascular graft.~   "
188648|NCT01095224|"~     The purpose of this study is to evaluate the safety and immune response of an~     adenovirus-based HIV-1 vaccine regimen that includes two vaccines given at different time~     points in HIV-uninfected adults.~   "
188649|NCT01095211|"~     Observation studies documented a correlation between plasma concentrations of homocysteine~     and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as~     effective homocysteine lowering treatment) can improve cognitive function in elderly people.~   "
188650|NCT01095198|"~     Up to 30% of Canadian women do not participate in Pap smear screening for cervical cancer~     prevention despite many being members of family practices and having access to family~     physicians. One reason is reluctance to undergo pelvic examination.~      The investigators purpose is to determine whether the offer of vaginal self sample collection~     for oncogenic human papillomavirus (HPV) testing increases participation in cervical cancer~     screening compared to repeat reminder for Pap smear testing among female family practice~     members who have not previously responded to invitations for Pap testing.~   "
188651|NCT01095185|"~     This is a prospective, double blind controlled trial in which patients with esophagic~     variceal bleeding treated with standard therapy (endoscopic variceal ligation(EVL) +~     B-blockers), will be randomized to receive statins or placebo. They will be followed up~     during 12 months to determinate whether statins are effective in prevention of variceal~     bleeding recurrence and evaluate patient survival.~      Randomization will be stratified according to the degree of hepatic insufficiency, assessed~     by the Child-Pugh classifications (A,B or C).~   "
188652|NCT01095172|"~     Hypothesis:~        -  That B cell depletion, rather than reducing acute rejection, will allow minimisation of~          immunosuppression, which may lead to better graft survival.~      Aim:~        -  To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression~          regime allows a reduction in steroid administration.~      Objectives:~        -  To assess whether B cell depletion affects graft function, acute rejection and~          complication rates~        -  To assess whether the T cell response to allotransplantation is impaired by B cell~          depletion.~   "
188653|NCT01095159|"~     This is a prospective, comparative randomized controled trial. The general purposes of this~     study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for~     female urinary stress incontinence.~   "
188654|NCT01095146|"~     Macrophage activation syndrome(MAS) is a complication of bone marrow suppression,~     coagulopathy and CNS dysfunction which occurs in rheumatic diseases. Normally the~     (Hemophagocytic Lympho-Histiocytosis) HLH-2004 criteria is used to diagnose patients with~     MAS. However this criteria is probably not sensitive and would probably be fulfilled quite~     late into the disease. Thus there would be an unacceptable delay. Ravelli et al came up with~     a different set of criteria based on data of patients reported in literature.~      Systemic onset juvenile idiopathic arthritis (SoJIA) is the most common cause of MAS. MAS in~     other rheumatic illnesses occurs in the setting on unbridled inflammation. In both SoJIA and~     uncontrolled rheumatic disease the patient is liable to have high WBC counts and high~     platelet counts. Bone marrow suppression which is one of the pathognomic features of MAS~     would be picked up very late if absolute cut off values were utilized. Kelly et al used the~     same arguments in their review to suggest that in MAS/Reactive hemophagocytic~     lymphohistiocytosis(ReHLH), the trend of change in laboratory parameters would be more useful~     than absolute cut offs. Hence the investigators propose new candidate criteria which are~     based on trends of laboratory parameters and seek to determine their utility in comparison to~     absolute cut offs of HLH or Ravelli criteria. The investigators also wanted to determine that~     among the Ravelli criteria and HLH-2004 criteria, which were fulfilled earlier in patients~     diagnosed as having MAS.~      Study hypothesis:-Criteria which measure serial trend of laboratory parameters would be~     fulfilled earlier than absolute cut offs when diagnosing MAS in patients with rheumatic~     illness.~   "
188655|NCT01095133|"~     The purpose of this research study is to learn about whether treating the esophagus with~     amiloride reduces either the frequency or the time to onset of acid-induced heartburn in~     patients with nonerosive reflux disease. In particular, we are looking at people who have~     either had complete relief while using a Proton Pump Inhibitor (PPI) or who have only had~     some relief of symptoms while on a PPI.~   "
188656|NCT01095120|"~     Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is~     being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line~     therapy to patients with advanced gastric cancer.~   "
188721|NCT01094275|"~     Clopidogrel, an inhibitor of ADP induced platelet aggregation and activation, is one of the~     most commonly used drugs in patients with cardiovascular disease. The specific aim of the~     proposed study is to determine whether the interaction between proton-pump inhibitors (PPIs)~     and clopidogrel is dependent on CYP2C19 haplotype.~   "
188657|NCT01095107|"~     Nutritional insufficiency is defined as an inadequate amount of nutrition due to decreased~     food/caloric intake, often due to an eating disorder, such as anorexia nervosa or bulimia.~     Often when re-feeding these chronically malnourished patients, they can experience changes in~     their mood and/or body image, metabolic abnormalities and functional aberrations of their~     gastrointestinal system described as re-feeding syndrome, which all can adversely effect~     their recovery. In our pilot study, we are attempting to determine whether adjustments in the~     amounts of energy dense foods, such as fat, in the current inpatient protocol meal plans will~     lead to a change in the hospital stay duration, alter their recovery by affecting vital~     signs, weight or need for supplemental feeds or medications, effect gastrointestinal~     re-feeding syndrome symptoms (bloating, gastroesophageal reflux, constipation, diarrhea,~     abdominal pain), and/or effect their perceived body image or cause any changes in their mood.~        1. To determine whether a higher amount of fat calories per day within a normal range in a~          Nutritional Insufficiency patient's diet will lead to a shorter inpatient hospital stay~          duration.~        2. To determine whether a higher amount of fat calories per day within a normal range in a~          Nutritional Insufficiency patient's diet will lead to less gastrointestinal re-feeding~          syndrome symptoms.~        3. To determine whether a higher amount of fat calories per day within a normal range in a~          Nutritional Insufficiency patient's diet will effect their body image and/or alter their~          mood.~   "
188658|NCT01095094|"~     RATIONALE: Ritonavir and lopinavir may stop the growth of gliomas by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase~     II trial is studying how well giving ritonavir together with lopinavir works in treating~     patients with progressive or recurrent high-grade glioma.~   "
188659|NCT01095081|"~     Prospective, non-interventional, multi-center study. The observation period for each subject~     covers the treatment period with Gadovist®. For each patient, the treating physician or nurse~     documents demographics, medical data, safety parameters and treatment signs and symptoms at~     the visit. Patients with severe renal impairment will be followed-up after 3 month by phone~     call from the investigator if in line with routine practice. Data audit/monitoring by source~     data verification will be done in a subset of sites and patients~   "
188660|NCT01095068|"~     The aim of this study is to evaluate the improvement in skeletal muscle energetic capacity,~     endothelial dysfunction and glycemic control induced by physical training in 20 sedentary~     patients with a type 2 diabetes.The protocol consists in a physical training program with 3~     sessions of 30 minutes per week during six consecutive weeks. A skeletal muscle biopsy, a~     cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed~     before and at the end of the physical training program.~   "
188661|NCT01095055|"~     This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63~     AMA1, simian adenovirus encoding Plasmodium falciparum blood stage antigen, Apical Membrane~     Antigen -1. All volunteers recruited will be healthy adults. They will be primed with various~     doses of AdCh63 AMA1 administered intramuscularly. Some of the volunteers will receive a~     booster vaccination with MVA AMA1 administered via intramuscular route. Safety data will be~     collected for each of the eight regimens. Secondary aims of this study will be to assess the~     immune responses generated by each of these regimes.~   "
188662|NCT01095042|"~     The study aims at showing that the susceptibility in the stress is more raised at the person~     affected digestive pathologies (SII or IBD) in forgiveness than healthy subjects.~   "
188663|NCT01095029|"~     The purpose of this study is to determine whether Sacral Nerve Stimulation (SNS) for~     idiopathic faecal incontinence affect cortical and deep brain activity in an acute and~     chronically stimulation model. Furthermore the association between brain activity and~     unilateral/bilateral SNS will be studied in each patient. Brain activity will be studied by~     use of positron emission tomography.~   "
188664|NCT01095016|"~     This is an open-label, randomized, cross-over, active-controlled study to evaluate the~     efficacy and safety effects using Meptin® Swinghaler and Berotec N® Metered Aerosol in stable~     asthma patients~   "
188665|NCT01095003|"~     The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line~     metastatic settings, led to a raise of patients presenting with metastatic breast cancer~     after treatment with these agents. Options for the treatment of patients who have progressed~     after an anthracycline and a taxane are limited. The high level of in-vitro synergy of~     vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the~     encouraging response rate observed while combining IV vinflunine to oral capecitabine make it~     a promising combination to investigate further in a phase III trial. This phase III trial~     will evaluate the effectiveness and the safety profile of such combination for the treatment~     of patient with advanced breast cancer previously treated with or resistant to anthracycline~     and taxane resistant.~   "
188666|NCT01094990|"~     Null hypothesis The proportions of vomiting are not different between dexamethasone and~     placebo in the patient after sedation with intravenous ketamine and lumbar puncture with~     intrathecal chemotherapy Alternative hypothesis The proportions of vomiting are different~     between dexamethasone and placebo in the patient after sedation with intravenous ketamine and~     lumbar puncture with intrathecal chemotherapy~   "
188667|NCT01094977|"~     The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces~     perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis~     surgery.~   "
188668|NCT01094964|"~     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above~     normal body temperature. Drugs used in chemotherapy, such as mitomycin C and epirubicin~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Biological therapies, such as bacillus~     calmette-guerin (BCG) and interferon alfa, may stimulate the immune system in different ways~     and stop tumor cells from growing. It is not yet known whether giving hyperthermia together~     with mitomycin C is more effective than giving BCG or standard therapy as second-line therapy~     in treating patients with recurrent bladder cancer.~      PURPOSE: This randomized phase III trial is studying how well hyperthermia given together~     with mitomycin C works compared with BCG or standard therapy as second-line therapy in~     treating patients with recurrent bladder cancer.~   "
188669|NCT01094951|"~     This two-stage research study will~        1. train caseworkers in three participating New York City Neighborhood Houses to screen~          their clients for depression, and~        2. examine the usefulness of training these caseworkers in an intervention that targets~          barriers seniors face in receiving mental health services. In this intervention, called~          ENGAGE, Case Workers will: 1. identify and address seniors' barriers to receiving mental~          health services; 2. include the seniors' preferences in deciding which treatment options~          to choose; and 3. help seniors connect with affordable mental health services of their~          choice.~   "
188670|NCT01094938|"~     To compare CO values obtained by the lithium indicator dilution method and pulse power~     analysis before, during and after anaesthesia and surgery for the elective repair of~     abdominal aortic aneurysms. This will enable us to determine how often and when calibration~     of the pulse power analysis derived CO is required.~   "
188671|NCT01094925|"~     Gabapentin has been very effective at treating pain after knee and hip operations,~     hysterectomies, and many other types of operations. A previous study at the investigators'~     hospital found that a single pre-operative dose of 600mg gabapentin produced a significant~     reduction in pain after caesarean section. However, 19% complained of sedation. The purpose~     of this study is to see whether a reduced dose of gabapentin will produce a similar~     improvement in pain scores while avoiding adverse effects such as sedation or dizziness. The~     objective of this study is to compare the efficacy of a single pre-operative oral dose of~     gabapentin 300mg, versus 600mg and placebo in women undergoing Cesarean section. The~     investigators' hypothesis is that gabapentin 300mg will result in decreased pain scores~     similar to gabapentin 600mg, but with reduced side effects.~   "
188672|NCT01094912|"~     Number of patients in mobile palliative care units have pain of both nociceptive and~     neuropathic origin. In certain cases, procedures of locoregional analgesia can be helpful.~      The Purpose of this study is to evaluate the impact of techniques of locoregional analgesia~     in a palliative population~   "
188673|NCT01094899|"~     Assumptions and Objectives: The working hypotheses are: 1 - subjects with type 1 diabetes and~     / or type 2, compared to subjects without diabetes are at risk for osteopenia and / or~     abnormal bone structure the foot (calcaneus and ankle) can lead to bone deformities,~     fractures and final stage of Charcot foot. These anomalies are favored by the presence of~     peripheral neuropathy and plasma levels of advanced glycation end products higher than in~     diabetic subjects without bone abnormalities.~      The objectives of this research are to evaluate these anomalies quantitative and qualitative~     bone in the foot (calcaneus and ankle) through the use of MicroScanner. In parallel a whole~     body bone mineral density (BMD) and calcaneal ultrasound will be performed to measure bone~     mineral density as realized in clinical practice in a defined population of patients with~     type 1 or type 2. These bone abnormalities will be correlated with the presence of peripheral~     neuropathy and the rate of advanced glycation end products of proteins and reference to~     parameters of chronic inflammation and oxidative stress to better understand the~     pathophysiology and target a population at risk.~      The importance of this study is paramount in the management of diabetic foot. Indeed for the~     moment we are dealing primarily the consequences of diabetes impact bone when bone~     deformities have appeared with their attendant disability and the risk of recurrent~     infections in areas of friction in this fragile environment. The ultimate goal is to target~     people with diabetes have abnormal bone subclinical and take care to avoid changes to bone~     deformities and find ways to treat them.~   "
188674|NCT01094886|"~     The study will describe the short-term effects the study drug, rivaroxaban, has on the body~     when a patient is switched from enoxaparin injection (by needle) to oral rivaroxaban (by~     mouth) for the prevention of blood clotting in the veins after elective total hip or total~     knee replacement surgery. After providing written informed consent, screening procedures will~     be completed to assess eligibility. After enrollment, all patients will be switched from~     enoxaparin to rivaroxaban. Blood samples for the short-term effects of rivaroxaban will be~     taken at various times while in the subacute unit. At the time of discharge, if the study~     doctor feels it is appropriate, an adequate supply of rivaroxaban will be provided to~     complete the full course of therapy. Upon completion of rivaroxaban therapy, all patients~     will be required to have final study procedures performed. Safety evaluations at the final~     visit will include clinical blood laboratory tests, a physical examination, urine pregnancy~     test (if applicable), recording of any adverse events including details regarding any~     bleeding episodes or blood clot events, and assessment of the surgical wound. All patients~     will return any unused study medication and study participation will be complete.~   "
188675|NCT01094873|"~     HCV002TV is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine~     against Hepatitis C virus (HCV) in chronically infected patients. The vaccine is based on the~     sequential delivery, by intramuscular route, of two different adenoviral vectors, of~     chimpanzee and human origin respectively, bearing the same genetic information for HCV~     antigens (NS region).~      The two recombinant vaccine vectors, called AdCh3NSmut and Ad6NSmut, are weakened and unable~     to multiply within the body; they are designed to induce an immune response against HCV~     proteins. AdCh3NSmut and Ad6NSmut are being used in the ongoing HCV001 study in healthy~     volunteers with very good safety and immunogenicity results.~      HCV002TV is a dose-escalation study; the AdCh3NSmut is administered as priming vaccination~     and Ad6NSmut as boosting vaccination.~      The trial includes:~        -  Arm A, in which vaccinated patients are into Interferon-ribavirin therapy (the gold~          standard therapy for hepatitis C);~        -  Arm B, in which vaccinated patients are not into therapy.~   "
188676|NCT01094860|"~     The goal of the clinical research study is to find the highest tolerable dose of nelarabine~     when given as a continuous infusion to patients with a lymphoid malignancy that has not~     responded to, or has come back after treatment with chemotherapy. The safety of this drug~     will also be studied.~   "
188677|NCT01094847|"~     The purpose of this study is to compare and explore bioavailability of mosapride, the main~     component of DWJ1252(Test drug) and mosapride medicine(Reference drug).~   "
188678|NCT01094834|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple administered DWP05195 in healthy volunteers~   "
188679|NCT01094821|"~     This is a pharmacodynamic study in healthy volunteers to determine the effects of a new 5-HT4~     agonist on gastric, small bowel and colonic transit.~   "
188680|NCT01094808|"~     This study is being done to evaluate the effects of pregabalin, a drug approved for~     anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy~     individuals.~      The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds,~     decreases sensation ratings, and increases compliance in response to balloon distension in~     the colon; 2) pregabalin reduces colonic phasic and tonic motility in response to a~     standardized meal; and 3) sensation ratings are lower with higher colonic compliance.~   "
188681|NCT01094795|"~     The primary purpose of this study is to assess incidence rates of targeted infections,~     malignancies and mortality among patients with rheumatoid arthritis who are treated with~     abatacept.~   "
188682|NCT01094782|"~     The purpose of this study is to explore a new approach in assessing the effectiveness of~     acupuncture therapy in the treatment chronic pain conditions.~   "
188683|NCT01094769|"~     The purpose of this study is to determine whether moxonidine is effective in reducing urine~     albumin levels in patients with diabetic kidney disease.~   "
188684|NCT01094756|"~     Central dopamine is thought to play a significant role in obesity. In support of this idea,~     animal studies and one human positron emission tomography (PET) study have found reduced~     postsynaptic D2-like receptor availability in the striatum in obesity, with lower D2 receptor~     availability associated with higher weight. In addition, reward sensitivity and hedonic~     responses, known to be related to dopamine function, have also been implicated in obesity and~     obesity-related eating behavior. These reports have led to the concept that dopaminergic~     abnormalities (e.g. reduced D2-like receptors) influence reward sensitivity, leading to~     altered eating behaviors and eventually obesity. However, there are several critical~     limitations of the human D2 receptor studies that limit the strength of their conclusions and~     thus the interpretations and speculations embedded in literature that relies on this work.~     First, estimates of D2-like receptors in humans have been confounded by potential differences~     in endogenous dopamine release since the PET ligand (raclopride) used is known to be~     displaceable from receptors by endogenous dopamine. Second, failure to rigorously screen~     obese individuals for diabetes confounds conclusions, since diabetes has been independently~     associated with dopaminergic abnormalities such as reduced D2-like receptors and muted~     dopamine release in diabetic rats. Finally, no human studies have addressed whether reduced~     D2-like receptor levels are a risk factor for obesity, a consequence of engaging in~     obesity-related behaviors or being obese or all of the above.~   "
188685|NCT01094743|"~     The purpose of this study is to compare visual acuity and redness of eyes between a prototype~     contact lens and an already marketed contact lens.~   "
188686|NCT01094730|"~     The purpose of this study is to compare lens surface characteristics and comfort between an~     experimental contact lens and a marketed contact lens.~   "
188687|NCT01094717|"~     The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene~     0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.~      The primary objective of this study is to compare the improvement of psoriatic plaques with~     and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded~     fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will~     be the comparison between the change in NPF score of plaques treated with excimer laser and~     those treated with sham treatment.~      The secondary objectives are to compare the number of excimer light treatments and time~     necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with~     acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to~     combinations of the study treatments.~   "
188688|NCT01094704|"~     Direct measurement of mucociliary and cough clearance (MCC/CC) has been used as a biomarker~     in cystic fibrosis (CF). Additional knowledge of the performance of this biomarker is needed~     to inform exploratory clinical trial design in support of programs to develop new inhaled~     therapies for CF. We hypothesize that MCC/CC measurements can be used to determine the~     durability of action of agents like hypertonic saline (HS) which increase epithelial lining~     fluid height.~   "
188689|NCT01094691|"~     To prospectively test whether the detection of three-dimensional, cast-like polyomavirus~     aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of~     intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the~     detection of 'Haufen' with histologic findings made in renal biopsies as well as signs of~     polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to~     further validate our retrospective findings (manuscript in press, J Am Soc Nephrology) and~     more specifically to correlate 'Haufen' shedding with the histologically confirmed course of~     PVN.~   "
188690|NCT01094678|"~     The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter~     single-arm study enrolling patients in Europe, Asia, and North America with de novo or~     restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal~     artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.~   "
188691|NCT01094665|"~     The primary objective of this study is to evaluate the safety and feasibility of Magnetic~     Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages~     40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an~     identifiable lesion on mutliparametric MRI, with a Prostate Specific Antigen (PSA) of <~     15ng/ml, who have not yet undergone pelvic radiation or hormonal deprivation therapy.~   "
188692|NCT01094652|"~     The Dietary Guidelines for Americans recommend that children and adolescents consume~     whole-grain products often; at least half the grains should be whole grains. Few, if any~     studies, examine the benefit of whole grains on the health of adolescents. The purpose of~     this study is to determine if adolescents eating diets rich in whole grains vs. diets rich in~     refined grains (i.e., a typical diet) have improved markers of digestive and immune health.~   "
188693|NCT01094639|"~     The purpose of this study is to examine the role of gum disease in affecting the long term~     prognosis of renal patients. This disease if untreated causes inflammatory response~     throughout the body. If the subject has gum disease, he/she will be randomly assigned to one~     of the two treatment groups. The study investigates what happens to inflammatory markers in~     blood and saliva after you are treated for gum disease.~   "
188722|NCT01094262|"~     The purpose of this study is to evaluate pain relief, safety, and tolerability of a new~     treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in~     comparison to a standard pain treatment and placebo.~   "
188694|NCT01094626|"~     The aim of the study is to evaluate the utility of secretin-enhanced MRI (S-MRI) in detecting~     and measuring pancreatic lesions in patients with known adenocarcinoma or Intraductal~     papillary mucinous neoplasm (IPMN) lesions. The hypothesis is that S-MRI is superior to MRI~     without secretin enhancement (N-MRI) in increasing tumor conspicuity, allowing for improved~     identification and more accurate measurement of lesions or precursor lesions in the pancreas.~   "
188695|NCT01094613|"~     The study is designed to evaluate the clinical efficacy and safety of daily treatment for 12~     weeks of oral administration of a delayed release, locally delivered 6MP (mercaptopurine)~     drug (80 mg), as compared to standard Purinethol (at a dose of 1-1.5 mg/kg/body weight), in~     alleviating the clinical, immunological and mucosal signs and symptoms of moderately active~     Crohn's Disease~   "
188696|NCT01094600|"~     The aim of our study is to evaluate S-MRCP, in comparison to direct pancreatic function, to~     measure pancreatic exocrine function in patients who have symptoms suspicious for~     insufficiency. We hypothesize that S-MRCP imaging parameters will correlate well with the~     direct pancreatic exocrine functioning.~   "
188697|NCT01094587|"~     This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis~     closure with a randomized control trial. The parameters of this trial were determined using~     our retrospective study as pilot data. Primary outcome measures will be time on ventilator~     and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome,~     length of hospital stay and the associated rate of complications, including bowel resection,~     sepsis, and death.~   "
188698|NCT01094574|"~     Previous studies have shown that the beta-adrenergic system plays a role in processing pain~     and the expression of hyperalgesia. Recent studies have investigated the analgesic effects,~     and potential anti-hyperalgesic effects (using a model of opioid induced (OIH) hyperalgesia)~     of propranolol, a beta adrenergic antagonist. We plan to further investigate the analgesic~     effects, and the potential anti inflammatory effects, of propranolol and compare those~     effects to alfentanil, an opioid of known effect, and placebo~   "
188699|NCT01094561|"~     The aim of our study is to evaluate the utility of Secretin-Stimulated Magnetic Resonance~     Cholangiopancreatography (S-MRCP) in detecting carcinoma and precancerous lesions in patients~     with a significant family history of pancreatic adenocarcinoma. Our hypothesis is that S-MRCP~     is superior to traditional computed tomography (CT) or magnetic resonance imaging (MRI) in~     detecting early pancreatic neoplasms, and approaches the accuracy of endoscopic ultrasound~     (EUS).~   "
188700|NCT01094548|"~     Tecemotide (L-BLP25) is believed to induce a Mucinous glycoprotein 1 (MUC1)-specific T-cell~     response after vaccination. The primary purpose of this study is to ascertain whether~     vaccination with tecemotide (L-BLP25) induces a MUC1-specific T-cell response in slowly~     progressive or chemotherapy naive multiple myeloma subjects.~   "
188701|NCT01094535|"~     The aim of this study will be to determine whether secretin-enhanced MRCP (S-MRCP) as well as~     traditional magnetic resonance imaging (MRI) of the pancreas will allow the investigators to~     quantify the pancreas' ability to secrete hormones as well as digestive enzymes, both before~     and after surgery. The investigators hypothesize that S-MRCP will provide a novel~     non-invasive measure of pancreatic function.~   "
188702|NCT01094522|"~     Study Population:~      Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery with~     CPB.~      The use of methadone to provide analgesia may be increasing due to advantages compared to~     other commonly used opioid analgesic drugs. While efficacy of methadone has been reported in~     adults, there is a paucity of information in neonates and infants. In the latter population,~     fentanyl and morphine are most commonly used for opioid analgesia following major surgery,~     while methadone is frequently used for weaning of opioid dependent and tolerant patients, in~     spite of the paucity of knowledge of methadone pharmacology in this population. There are~     several clinical problems associated with fentanyl and morphine, and methadone may offer~     superior efficacy with fewer side effects than these agents. We propose to study the~     pharmacokinetics (PK) and pharmacodynamics (PD) of methadone in neonates and infants in the~     intensive care unit following cardiac surgery.~   "
188703|NCT01094509|"~     Cognitive aging and cognitive decline are important public health concerns in an aging US~     population. The investigators will conduct a randomized controlled trail among healthy older~     adults to assess effects of several innovative activities on remediation of age-related~     cognitive decline.~   "
188704|NCT01094496|"~     The major purpose of this study is to examine the anti-tumor activity of the CDX-1307 vaccine~     regimen when it is given before and after bladder cancer surgery. The study will also provide~     information about the safety of the vaccine regimen when given in combination with~     chemotherapy, and how it affects the immune systems.~   "
188705|NCT01094483|"~     The primary hypothesis of this study is that concomitant multiple-dose administration of PN~     400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose~     aspirin (81 mg), as measured by serum thromboxane B2 inhibition.~   "
188706|NCT01094470|"~     The purpose of this study was to investigate the effects of gait training on ground level~     with partial body weight support (BWS)in individuals with stroke during overground walking~     with no BWS.~   "
188707|NCT01094457|"~     Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of~     ischemic events and can be detected by laboratory tests. This multicenter, randomized study~     is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double~     clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary~     stenting.~   "
188723|NCT01094249|"~     The purpose of this study is to evaluate the potential effect of multiple oral doses of an~     extended release formulation of paliperidone on the pharmacokinetics (blood levels) of~     valproic acid (VPA) in patients with schizophrenia, bipolar I disorder, or schizoaffective~     disorder.~   "
188724|NCT01094236|"~     The goal of the Playground supervision clinical trial is to see if playground management~     skills are improved, after implementing the school-wide behavior management program.~   "
188739|NCT01094041|"~     The specific hypotheses are:~      Gluten supplementation for four weeks increases small intestinal permeability and accelerates~     colonic transit in patients with irritable bowel syndrome with diarrhea (IBS-D) or functional~     diarrhea (FD) who are HLA-DQ2 positive.~   "
188708|NCT01094444|"~     The study aims to explore the benefit of topical vitamin K3 lotion for the~     reactivation/rephosphorylation of EGF-receptor in the skin and the possible reduction in~     cutaneous side effects of EGFr-inhibition.~      Primary aim: The possible reduction of cutaneous side effects: folliculitis, dryness and~     redness of the skin.~      Secondary aim: To explore any possible side effects of topical vitamin K3 lotion.~      Methods: 36 patients with metastatic colorectal cancer or metastatic head and neck cancer~     allocated to treatment with chemotherapy and biweekly cetuximab. Two equally sized areas of~     at least 10x10 cm on the back or chest of the patient is marked. Patients receive in a double~     blinded procedure placebo lotion on one side and vitamin K3 lotion on the other side. The~     treatment may last for a maximum of two months and the patients are followed biweekly with~     photos, VAS-scores, questionnaires and CTCAE estimations. The patient will be able to take~     weekly photos at home during the weeks they are not seen at the outpatient clinic. During the~     treatment all other skin products or antibiotics is allowed and will be carefully registered~     by the health care professionals in the outpatient clinic.~      The patient may enter the trial in two different ways: 18 patients start treatment with study~     lotions at the time they start treatment with cetuximab. The other 18 patients start~     treatment with study lotions when folliculitis appears.~      Patients are asked for 1.5 mm skin biopsies of both study areas of the skin before start of~     treatment and after 4 weeks of treatment with placebo lotion and vitamin K3 lotion. These~     biopsies will be investigated for EGFr, phosphorylated EGFr and other central downstream~     mechanisms. The biopsy part of the study is optional for the patient.~   "
188709|NCT01094431|"~     The purpose of this study is to study the most common etiologies of uncomplicated fever~     diseases among children under five years of age in rural Zanzibar.~   "
188710|NCT01094418|"~     The purpose of this study is to evaluate the distal sensory nerves of the feet, namely, the~     dorsal sural, medial dorsal cutaneous and medial plantar nerves, in patients with impaired~     glucose tolerance and diabetes mellitus type 2 and compare these parameters to those from~     healthy participants.~   "
188711|NCT01094405|"~     The purpose of this study is to evaluate the efficacy (clinical benefit rate) of MVA~     EBNA1/LMP2 vaccine in patients with persistent, recurrent or metastatic nasopharyngeal~     carcinoma, and its impact on disease progression.~   "
188712|NCT01094392|"~     Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but~     severe side effects to the treatment is thrombosis in or outside the central nervous system.~      The aim of this study is to investigate and describe the influence on the coagulation~     parameters during prolonged treatment with asparaginase.~      Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it~     possible to prevent these.~   "
188713|NCT01094379|"~     Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic~     gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result,~     reduced postoperative pain, shorter hospital stay and rapid return to normal activity.~     Although reduced, however, pain is still substantial and constitutes the main clinical~     problem after laparoscopic cholecystectomy, especially for planned day case procedures.~      Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all~     instruments are inserted through the same umbilical incision. The single incision~     laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and~     safe by several studies.~      The purpose of the study is to compare postoperative pain and operating time, nausea,~     vomiting, tissue damage, pulmonary function, cosmetic result, quality of life between SILS~     and standard laparoscopic cholecystectomy.~   "
188714|NCT01094366|"~     Many woman undergoing a surgical abortion receive a paracervical nerve block for pain~     reduction, in which lidocaine (a numbing medication) is injected around the cervix. These~     injections numb the cervix and possibly the lower part of the uterus. However, the injection~     can be uncomfortable and it is not well known whether it is effective in reducing pain. The~     purpose of this study is to determine the level of pain women experience with a surgical~     abortion and the effect that paracervical block might have on that pain.~   "
188715|NCT01094353|"~     A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot~     with minisling.~   "
188716|NCT01094340|"~     This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of~     thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with~     mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of~     treatment with Thalidomide on plasma biomarkers.~   "
188717|NCT01094327|"~     Patients with focal segmental glomerulosclerosis (FSGS) who progress rapidly to end stage~     renal disease (ESRD) are at highest risk for development of recurrence of proteinuria~     following kidney transplantation. This study will look at serum specimens pre and post~     transplant, as well as kidney transplant specimens pre and post reperfusion to identify where~     the defects has occured that results in recurrence of proteinuria in a given kidney~     transplant.~   "
188718|NCT01094314|"~     The purpose of this study is to compare two culture media.~   "
188719|NCT01094301|"~     Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person~     has had a stroke. The SPR System is an investigational device that is being studied for the~     relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes~     a Trial Stage (where a temporary system is used to see if the subject may benefit from this~     type of therapy) and may include an Implant Stage (where a small device is implanted under~     the skin in the chest). The SPR System delivers mild electrical stimulation to the muscles in~     the shoulder where the subject feels pain. This research study will evaluate the effect of~     electrical stimulation on shoulder pain.~      Individuals who are over the age of 21, who had a stroke at least six months ago, who~     experience shoulder pain, and have tried other therapies for their shoulder pain, may be~     eligible to participate in the first stage of the SPR System. Subjects meeting the specified~     success criteria at the conclusion of the SPR Trial Stage who experience a return of pain~     within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR~     Implant Stage). This research study lasts a little over 3 years and may include 17 visits to~     the study doctor and at least 8 telephone calls from study staff.~   "
188720|NCT01094288|"~     This is an open-label, multicenter, Phase 1 study that will evaluate the safety and~     tolerability of MLN8237 given orally in combination with docetaxel as a treatment for~     advanced solid tumors to determine tolerable doses and schedules of MLN8237 and docetaxel to~     be evaluated in future Phase 2 studies.~   "
188725|NCT01094223|"~     The broad, long-term objective of the current research is to improve treatment for stimulant~     use disorders by augmenting traditional relapse prevention therapy with innovative~     meditation-based strategies to promote affect regulation skills. Based on Mindfulness-Based~     Cognitive Therapy for depression (Segal, Teasdale, & Williams, 2002), Marlatt and colleagues~     recently developed a manualized intervention for the treatment of substance using~     populations: Mindfulness Based Relapse Prevention (MBRP). The specific aims of this research~     are 1) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting~     and retaining individuals for a large scale study and to determine the effect size of MBRP~     relative to a health education (ED) control group in stimulant users receiving contingency~     management (CM). Both MBRP and ED participants will be assessed at baseline, treatment-end,~     and 1 month post-treatment. 2) To test the impact of MBRP compared to ED on negative affect,~     stimulant use, and health care outcomes. 3) To evaluate the differential effects of MBRP~     versus ED on HIV-risk behavior of participants, and 4) To examine potential mechanisms of~     action of MBRP, including reductions in stress reactivity and biological indicators of~     arousal such as blood pressure and heart rate. The investigators hypothesize that MBRP will~     be more efficacious than ED in reducing negative affect and stimulant use. Further, the~     investigators expect that MBRP will produce greater reductions in HIV-risk behaviors, stress~     reactivity, and arousal, and these changes will be associated with substance use outcomes.~     MBRP incorporates specific substance-focused cognitive therapy techniques with an additional~     emphasis on mindfulness skills. By providing coping skills to address affect regulation and~     stress reactivity, two important factors in stimulant relapse, MBRP may provide a promising~     augmenting strategy for the treatment of stimulant users.~   "
188726|NCT01094210|"~     The purpose of this trial is to evaluate the anticaries remineralizing potential of a~     toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially~     available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model,~     whereby approved human participants will wear an orthodontic appliance fitted with an enamel~     specimen for the duration of a leg (28 days). There will be two test legs.~   "
188727|NCT01094197|"~     Individuals who experience traumatic injury often require blood transfusion. In some~     individuals who receive blood after an injury, white blood cells from a person who donated~     blood may remain in the body for years, a condition known as microchimerism. This study is~     designed to examine a group of people who are known to have long-term microchimerism and,~     through analysis of their blood, determine whether there is evidence that the microchimerism~     involves blood stem cells that can become any type of blood cell (red blood cells, white~     blood cells, or platelets) and that might be a permanent part of the body.~   "
188728|NCT01094184|"~     This open-label, multi-center study will evaluate the safety, tolerability and effect of~     bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on~     disease progression, survival time and Karnofsky performance status in female participants~     with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative~     (triple-negative) breast cancer.~   "
188729|NCT01094171|"~     The purpose of this study is to assess reactogenicity and safety of simultaneous~     administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK~     Biologicals' DTPa-vaccine Infanrix vaccines in healthy children in Russian Federation in~     their first year of life according to National Calendar of Prophylactic Immunisation of~     Russian Federation.~   "
188730|NCT01094158|"~     Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol~     versus the placebo arm following three month treatment.~      Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin~     resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol~     and the placebo arms.~   "
188731|NCT01094145|"~     In the study at hand, six patients with light to moderate Alzheimer's disease will be~     enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert.~   "
188732|NCT01094132|"~     Precancerous lesions of the cervix occur frequently and are treatable. This justifies a~     population-based screening program. Following an abnormal Pap smear, patients are referred~     for a colposcopic exam to confirm the presence/stage of disease and select appropriate~     treatments. Unfortunately, these approaches do not detect all lesions or can sometimes give~     'false positive' results (resulting in overtreatment). We are testing a device called a~     'multispectral digital colposcope' to determine whether it is more effective at detecting~     precancerous cervical lesions than existing tools. Success in our study will make diagnoses~     more accurate and reduce the costs associated with unnecessary treatments.~   "
188733|NCT01094119|"~     Recently, a novel posterior heating system has been developed that provides enhanced pressure~     relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this~     FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal~     surgery. The investigators therefore propose to test the hypothesis that intraoperative~     distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body~     forced-air warming in patients undergoing open major abdominal surgery under general~     anesthesia.~      Secondary hypotheses include that:~        1. intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air~          warming~        2. final intraoperative core temperature is non-inferior with PerfecTemp than upper-body~          forced-air warming~        3. final intraoperative core temperature is superior with PerfecTemp than upper-body~          forced-air warming.~   "
188734|NCT01094106|"~     Infiltration of a local anesthetic into the surgical wound is a simple method to strive to~     control postoperative pain after surgery. In the investigators institution, this method is~     used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover,~     the cost of the single use elastomeric pump used with this procedure is clearly higher than~     the costs of other routinely used analgesic methods.~      According to the investigators observations, infiltration of a local anesthetic into the~     surgical wound after caesarean section seems to reduce the need for rescue analgesics.~     However, the scientific evidence of the efficacy of this technique is weak. The investigators~     decided to conduct a prospective, controlled, randomised, double blind trial on this topic.~      The hypothesis is that wound infiltration with local anesthetic will reduce postoperative~     pain and opioid consumption after caesarean section without major adverse effects.~   "
188735|NCT01094093|"~     The purpose of this study is to assess the safety and tolerability of AMG 139 following~     single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and~     subjects with moderate to severe psoriasis (PsO).~   "
188736|NCT01094080|"~     In this study, the suitability of an infant formula with a modified content of protein and~     fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.~      Primary hypothesis to be tested is: an infant formula with a modified protein content is non~     inferior compared to a standard infant formula in respect to the growth of healthy term~     infants.~   "
188740|NCT01094028|"~     During the first hours that follow the birth of the baby (third and fourth stages of labor),~     complications are common and can threaten the mother's life. The most common complication is~     postpartum hemorrhage (PPH), which remains a leading cause of maternal mortality (25.0%)~     especially in developing countries .Three to five percent of deliveries are complicated by~     PPH and is 50 times more common in developing countries. Retained placenta is an another~     complication of third stage of labor. It complicates 0.1-2 % of deliveries . Without prompt~     treatment, women are at high risk of hemorrhage. At present, treatment is by manual removal~     of placenta, which needs an operating theatre, a surgeon, and an anaesthetist—facilities that~     are often unavailable to women in resource-poor settings. As a result, this condition has a~     case fatality rate of nearly 10% in rural communities.~      The length of the third stage of labor, and its subsequent complications depends on a~     combination of the length of time it takes for placental separation and the ability of the~     uterine muscle to contract. Principal management of the third stage of labor is aimed at~     reducing the time of delivery of placenta so minimising serious adverse effects, such as~     blood loss and retained placenta. Active management of the third stage of labor, which~     includes prophylactic injection of 10 units of oxytocin within two minutes of birth, early~     clamping of the umbilical cord and controlled cord traction (CCT), is recommended by WHO for~     PPH prevention .~      Umbilical vein oxytocin injection directs the treatment to the placental bed and uterine~     wall, resulting in an earlier uterine contraction and placental separation. However, very~     limited published literature is available, which evaluated the effect of umbilical vein~     oxytocin injection in routine practices for active management of the third stage of labor.~     The purpose of this investigation was to find out the beneficial effect of adding~     intraumbilical vein oxytocin in reducing the blood loss during third and fourth stages of~     labor, length of third stage of labor, and reduction in the incidence of manual removal of~     retained placenta.~   "
188741|NCT01094015|"~     The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain~     during hysteroscopy diagnostic practice.~   "
188742|NCT01094002|"~     Objectives: To compare the benefits of structured occupational therapy intervention by a~     single geriatric therapist with the benefits of the conventional treatment model in the~     functional recovery of patients admitted to an acute geriatric unit.~      Design: Non-pharmacological randomised clinical trial. Setting: Acute Geriatric Unit,~     Albacete, Spain. Participants: The trial included 400 patients admitted consecutively over 6~     months to an acute geriatric unit for acute illness or exacerbation of a chronic medical~     condition. Participants were randomised to the occupational therapy intervention or~     conventional treatment model group; 198 patients received occupational therapy. All patients~     completed the study. The mean age was 83.5, and 56.8% were women.~      Interventions: Needs assessment, iatrogenic prevention, retraining in basic and instrumental~     activities of daily living, assessment of need for technical aids, instruction for primary~     caregiver in patient mobilisation techniques, and structured social and occupational~     motivation as per protocol in three groups of patients (cardiopulmonary disease, stroke, and~     other conditions) 5 days a week, 30 to 45 minutes a day over the entire hospital stay.~   "
188743|NCT01093989|"~     The research questions to be answered by this study are:~        1. Is treatment with iron more effective at improving anemia if given at the time of a~          malaria episode or 1 month after the episode?~        2. Which treatment timing is associated with more malaria episodes - 1 month delayed~          treatment or immediate treatment at the time of malaria?~        3. Does timing of iron treatment affect later thinking processes and behavior?~   "
188744|NCT01093976|"~     The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in~     individuals with obsessive-compulsive disorder (OCD) or the obsessive-compulsive spectrum~     disorders, trichotillomania (TTM) or pathological skin picking (PSP). Fifteen patients with~     OCD, TTM, or PSP will receive 12 weeks of open-label treatment with dronabinol. The~     hypothesis to be tested is that dronabinol will be effective and well tolerated in patients~     with these disorders. The proposed study will provide needed data on the treatment of a~     disabling disorder that currently lacks a clearly effective treatment.~   "
188745|NCT01093963|"~     The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant~     (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.~   "
188746|NCT01093950|"~     A white light scanner can more accurately measure body contouring subjects than standard~     anthropomorphic methods.~   "
188747|NCT01093937|"~     Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated,~     expansive and irritable mood, often alternating with periods of significant clinical~     depression. People with Bipolar Disorder are typically heavy smokers who have difficulty~     quitting, and this is associated with significant tobacco-related medical illness and death.~      The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the~     safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder.~     This medication is the latest first-line pharmacotherapy for smoking cessation and has been~     shown to be efficacious for smoking cessation, but has not yet been systematically studied in~     persons with Bipolar Disorder.~   "
188748|NCT01093924|"~     This is a 5-year community-based participatory research intervention study with the goals of~     1) conducting a more definitive study of weight loss maintenance in Native Hawaiians and~     Pacific Peoples and 2) identifying the aspects of the community-academic partnership that~     fosters a co-learning and co-equal environment.~   "
188749|NCT01093911|"~     To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657~   "
188750|NCT01093898|"~     This study will measure the brain activity of adolescent substance abusers while they make~     decisions about their preferences to receive smaller, immediate rewards versus larger delayed~     rewards. The investigators expect that patterns of brain activity while engaged in this~     decision making task will predict response to treatment among adolescent substance users. The~     investigators expect to use the results of this study to develop more effective treatments~     for adolescent substance abuse~   "
188765|NCT01093703|"~     The purpose of this study is to identify and manage factors related to blood pressure control~     that impact organ function and survival in kidney transplant recipients. Loss of the~     circadian (relating to a 24-hour rhythm) blood pressure pattern is common in kidney~     transplant recipients and is associated with poor allograft kidney function. It is still~     unclear if restoring the normal day-night blood pressure (BP) pattern will translate into~     better allograft outcome. Although studies in patients with and without chronic kidney~     disease indicate that restoration of the normal nocturnal (night) dipping in BP is possible~     by changing the timing of the BP medications to cover the overnight period (chronotherapy),~     this has not been tested in kidney transplant patients.~   "
188766|NCT01093690|"~     The objective of this study is to assess the efficacy and tolerability of metoclopramide~     added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.~   "
188767|NCT01093677|"~     LIM-0705 will gain results on the effects of LIM-0705 on Male Subjects with Impaired Glucose~     Tolerance~   "
188751|NCT01093885|"~     Systemic sclerosis is a chronic autoimmune connective tissue disorder with no universally~     accepted disease modifying regimen. Recruiting patients for systemic sclerosis treatment~     studies is difficult due to the limited availability of such patients and furthermore the use~     of a placebo arm is often deemed unethical due to the poor survival of diffuse systemic~     sclerosis patients.~      Long-term controlled trials examining functional outcomes and survival from novel therapeutic~     agents for systemic sclerosis are often difficult to undertake because of costs, rarity of~     the disease and ethical issues with the use of a true placebo. Open label single center~     studies while inferior to multicenter placebo controlled studies, have helped establish the~     benefits of certain pharmaceutical agents in systemic sclerosis, and while not universally~     accepted as disease modifying agents, have been used with some success to treat systemic~     sclerosis.~      The hypothesis on which we are basing this study is that an endothelin receptor antagonist~     and disease modifying agent with antifibrotic properties will have additive influence on~     fibrosis, inhibit cellular and humoral hyperactivity and interfere with smooth muscle~     proliferation in the vessel wall. The combination of these two agents will also be the first~     regimen to address the heterogeneity of scleroderma manifestations including ILD, pulmonary~     arterial hypertension and skin manifestations~   "
188752|NCT01093872|"~     In this study, we perform an open-label rTMS over the left AC on patients with tinnitus.~     Outcome measures will be evaluated statistically. The results will be instrumental in~     deciding the efficacy of this technique in a local patient group.~   "
188753|NCT01093859|"~     Exploratory phase 1, first in human, open label, non-randomized, single-dose study of~     PRX-105, administered intravenously by slow bolus injection to 10 healthy volunteers. The~     objective is to evaluate the pharmacokinetic profile of PRX-105 without any significant~     physiological effect in healthy volunteers after a single, intravenous microdose~     administration.~   "
188754|NCT01093846|"~     A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled~     study to assess the difference in the rate of recurrent exacerbations in Behçet's patients~     with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care~     immunosuppressive therapy~   "
188755|NCT01093833|"~     The purpose of this study is to compare two continuous glucose sensors, one placed~     subcutaneous (under the skin) and one placed intradermal (in the skin) over 12-14 hours.~   "
188756|NCT01093820|"~     Hypothesis:~      Based on available pharmacokinetic data from healthy volunteers we hypothesize that the~     administration of a cumulative dose of 210μg of the continuous erythropoietin receptor~     activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI)~     does not result in hemoglobin (Hb) levels >15 g/dl in patients with ST-segment elevation~     myocardial infarction (STEMI)~      Design:~      Prospective, open label single center pilot study~   "
188757|NCT01093807|"~     The purpose of this study is to evaluate the efficacy and safety of various dosage~     combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with~     their respective components and with placebo.~   "
188758|NCT01093794|"~     This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin~     50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of~     corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be~     bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and~     metformin.~   "
188759|NCT01093781|"~     The goal of this proposal is to conduct a pilot study to access the antiproteinuric effect of~     aliskiren in patients with idiopathic membranous nephropathy. Patients will be treated for 3~     months with aliskiren aiming to achieve the maximum tolerated dose and blood pressure (>100~     but <125 mmHg systolic BP >75% of the readings).~   "
188760|NCT01093768|"~     This research study investigates the effects of oxytocin and vasopressin on brain activity in~     adults with Autism Spectrum Disorders using functional magnetic resonance imaging (fMRI).~      Background:~      - Oxytocin and vasopressin are two hormones produced in the brain. Both hormones can~     influence activity in brain regions such as the amygdala that are involved in social and~     emotional processing. There is evidence suggesting that oxytocin and vasopressin may be~     implicated in autism spectrum disorders (ASD).~      Objectives:~      -Here, we use functional magnetic resonance imaging (fMRI) to assess the effects of oxytocin~     and vasopressin on brain activity in adult healthy volunteers and adults with ASD.~      Eligibility:~      - Right-handed individuals between 18 and 40 years of age who either have been diagnosed with~     autism, Asperger s disorder, or Pervasive Developmental Disorder- Not Otherwise Specified~     (PDD-NOS), or are healthy volunteers.~      Design:~        -  This study requires 3 outpatient visits to the NIH Clinical Center in addition to a~          screening visit. Each visit will last about 2.5 hours. Participants may not smoke~          cigarettes or drink alcohol or caffeinated beverages for 12 hours before each visit.~        -  During each visit, participants will receive a nasal spray that contains one of the~          following: oxytocin, vasopressin, or placebo. Participants will receive a different~          spray at each visit.~        -  After using the nasal spray, participants will have an MRI scan of the brain while~          performing tasks with social and emotional stimuli.~        -  After the MRI scan, participants will complete questionnaires about mood and reaction to~          the tasks, and will remain in the clinic until the effects of the study medication have~          worn off.~        -  Participants will be contacted 1 day after each MRI scan for follow-up purposes.~   "
188761|NCT01093755|"~     The investigators hypothesize that intensive acid suppression with a long acting high potency~     proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of~     inflammatory mediators (compared to conventional PPIs) in the esophagus, which could~     potentially lead to decreased recurrence of intestinal metaplasia following endoscopic~     ablation.~   "
188762|NCT01093742|"~     -  Study Design~             -  Randomized, Double-blind, Placebo-controlled, escalating single-dose design.~             -  Four ascending dose cohorts.~             -  In each cohort, subjects will be randomized to receive a single dose of HM10560A or~               placebo (negative control).~        -  Objectives~             -  The primary objective of the study is to assess the safety and tolerability of~               single escalating subcutaneous doses of HM10560A in healthy male subjects.~   "
188763|NCT01093729|"~     Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design.~     Five ascending dose cohorts are planned.~   "
188764|NCT01093716|"~     Null hypothesis: There will be no significant difference in the change in craving parameters~     between right and left prefrontal high frequency rTMS in patients with alcohol dependence.~   "
188768|NCT01093664|"~     This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with~     regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who~     have received the vaccine within the clinical study AFF002.~   "
188769|NCT01093651|"~     We will test the safety of a new class of anti-diabetes compounds (DPPIV-inhibitors) in~     people living with HIV. Future trials will examine efficacy for treating diabetes and~     reducing cardiovascular disease risk in people living with HIV.~   "
188772|NCT01093612|"~     RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help~     doctors to plan a better treatment~      PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid~     (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal~     growth factor receptor 2 (HER2)-positive breast cancer.~   "
188773|NCT01093599|"~     The Mindfulness Training for Smokers study follows a randomized controlled design with 240~     total participants. Both the study group and the control group will be enrolled in the~     Wisconsin Tobacco Quit Line and will receive four weeks of nicotine patches. The control~     group will receive the Quit Line intervention alone where as the study group will receive the~     Quit Line intervention plus the Mindfulness for Smokers Intervention. The Mindfulness for~     Smokers Intervention provides four weeks of instruction in mindfulness meditation followed by~     four weeks of participation in a weekly meditation group. The principal hypothesis for the~     study is that Mindfulness for Smokers plus the Quit Line will lead to significantly higher~     rates of smoking cessation at 6 months than the Quit Line alone.~   "
188774|NCT01093586|"~     RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps~     stop the growth of cancer and abnormal cells and helps stop the patient's immune system from~     rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not~     exactly match the patient's blood, are infused into the patient they may help the patient's~     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil~     after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell~     transplant works in treating patients with hematologic malignancies.~   "
188775|NCT01093573|"~     RATIONALE: Midostaurin may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Midostaurin may help azacitidine kill more cancer cells by making the cancer cells~     more sensitive to the drug. PURPOSE: This phase I/II trial is studying the side effects and~     best dose of midostaurin when given together with azacitidine and to see how well it works in~     treating elderly patients with acute myelogenous leukemia.~   "
188776|NCT01093560|"~     Among 10 premenopausal women with Metabolic Syndrome:~      Specific Aim 1: Compare the effects of acute fat feeding on flow mediated dilation (FMD) as~     measured by brachial artery reactivity among three fat challenges (saturated fat vs.~     monounsaturated fat (MUFA) vs. polyunsaturated fat (PUFA)at 4 hours post feeding. Hypothesis~     Saturated fat feeding will impair FMD but MUFA and PUFA feeding will not.~      Specific Aim 2: Compare the effects of acute feeding on vascular inflammation as measured by~     VCAM and sICAM among three fat challenges at 3 1/2 hours post feeding.~      Hypothesis: Saturated fat feeding will increase vascular inflammation but MUFA and PUFA will~     not.~   "
188777|NCT01093547|"~     Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in~     non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to~     investigate if the use of Extraneal (which is a mixture of high weight glucose polymers),~     instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in~     non-diabetic CAPD patients.~   "
188778|NCT01093534|"~     The purpose is to see if solifenacin has any effect on bladder wall thickness and urine~     inflammatory marker measurements after 12 weeks of treatment.~   "
188779|NCT01093521|"~     The purpose of this research study is to test the pharmacokinetics, safety, and tolerability~     of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic~     fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the~     drug are found in the sputum.~      Funding Source - Food and Drug Administration (FDA) Office of Orphan Products Development~     (OOPD)~   "
188780|NCT01093508|"~     The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916~     when administered as a single dose~   "
188781|NCT01093495|"~     There is little data published concerning the best approach to nasal continuous positive~     airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP~     therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial~     infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the~     use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP~     may be beneficial. On the other hand, removing CPAP too early may lead to complications that~     include: increasing apnea, increased oxygen requirement, increased work of breathing, the~     need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental~     study have demonstrated an improvement in lung growth after the prolonged use of CPAP.~      Nasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of~     preterm infants. The use of NC flow to generate positive airway pressure would minimize many~     of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas~     that is inadequately warmed and humidified, limiting the use of such flows due to increased~     risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.~      The purpose of this randomized controlled trial is to evaluate the clinical impact of two~     methods for weaning preterm infants from nCPAP.~   "
188782|NCT01093482|"~     The objective of this study is to obtain a better understanding of the spectrum of use of~     mechanical ventilation in intensive care units:~        1. Main analysis: To know the all-cause mortality rate in mechanically ventilated patients~        2. Secondary analyses:~             -  To know the current status of mechanical ventilation in the intensive care unit and~               determine the number and percentage of patients who are admitted to an intensive~               care unit and require mechanical ventilation.~             -  To compare the results with prior data collected in previous observational studies~               (1998 and 2004)~             -  Non-invasive positive pressure ventilation~             -  Weaning~             -  Use of adjuvant therapies as steroids or selective digestive decontamination~             -  Sedation including prevalence of delirium in mechanically ventilated patients~             -  Prediction of the duration of mechanical ventilation~             -  Other~   "
195541|NCT01003886|"~     This study aims to assess the safety, tolerability and efficacy of Doxazosin GITS in Filipino~     patients diagnosed with Benign Prostatic Hyperplasia (BPH) under the usual clinical care~     setting.~   "
188783|NCT01093469|"~     The purpose of this study is to compare the efficacy and cost effectiveness of Aquaphor~     Healing Ointment, Atopiclair and EpiCeram as a monotherapy in mild to moderate AD.~      The investigators hypothesize that no statistical difference will exist in the efficacy~     between an over-the-counter moisturizer, Aquaphor Healing Ointment, compared to prescription~     devices Atopiclair and EpiCeram in treating mild to moderate AD. Therefore, Aquaphor will be~     most cost-effective than Atopiclair or EpiCeram.~   "
188784|NCT01093456|"~     Study on the daytime variation of uremic retention solutes and markers of bone-mineral~     metabolism in patients with end-stage kidney disease treated with peritoneal dialysis~   "
188785|NCT01093443|"~     In this prospective study, the investigators would like to show whether ovarian stimulation~     with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle,~     is possible.~   "
188786|NCT01093430|"~     The purpose of this study is to study port symmetry and the incidence of anterior abdominal~     wall neuropathy associated with gynaecological surgery.~   "
188787|NCT01093417|"~     The purpose of this study is to evaluate how Vitamin D affects endothelial function,~     inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).~   "
188788|NCT01093404|"~     Treatment of myocardial infarction (blood clot in the arteries of the heart) has improved~     after introduction of 24/7 balloon angioplasty to open the blocked artery. However, the clot~     itself is not routinely removed but recent data in smaller trials indicate that this might~     improve recovery and prognosis. In this multicenter study of 5000 patients referred to~     Scandinavian hospitals for myocardial infarction the investigators test the hypothesis that~     patients randomized to treatment with thrombus aspiration (removing the blood clot by manual~     suction) before conventional angioplasty will have a reduced risk of death, fewer~     rehospitalisations, fewer new myocardial infarctions, reduced risk of heart failure, better~     coronary artery flow after angioplasty and greater reduction of infarct size compared to~     patients randomized to conventional angioplasty alone.~   "
188789|NCT01093391|"~     The objective of this study is to evaluate the security issues and efficacy of coronary~     stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with~     coronary artery lesion.~   "
188790|NCT01093378|"~     This case-control multicentric study involving fertile and infertile couples aims at~     evaluating the impact on conception rate of nutritional parameters (biologic, clinic,~     anthropometric, and food questionnaire).~   "
188791|NCT01093365|"~     Smokers with schizophrenia have more difficulties quitting smoking than smokers without a~     mental disorder. Varenicline (Champix) is a new stop smoking medication with a unique~     mechanism of action. It is a nicotine-like drug which is not addictive and not associated~     with the health risks of tobacco smoking.~      Varenicline (VAR) binds to sites in the brain called nicotine receptors that play an~     important role in nicotine dependence. People with schizophrenia have difficulties in~     concentrating and remembering. Scientists believe that people with schizophrenia use smoking~     to remedy their cognitive problems. We will test VAR to see if it improves cognitive problems~     in smokers with schizophrenia in comparison to non-mentally ill smokers to determine whether~     people with schizophrenia get direct benefit from this nicotine-like drug. It is hypothesized~     that VAR (in comparison to a placebo) will reduce aspects of cognitive impairment in smokers~     and nonsmokers with schizophrenia.~   "
188792|NCT01093352|"~     The purpose of this pilot clinical trial is to evaluate whether alveolar-decortication has~     the potential to reduce orthodontic treatment time following surgical exposure of palatally~     impacted canines.~   "
188793|NCT01093339|"~     The purpose of this study is to determine if sleep deprivation results in increased~     esophageal acid exposure in healthy controls and gastroesophageal reflux disease (GERD)~     patients.~   "
188794|NCT01093326|"~     This study is an extension to the study AC-058B201 and will investigate the long-term safety,~     tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple~     sclerosis.~   "
188795|NCT01093313|"~     The present study aimed to investigate the efficacy and process of change that occurs in~     Attention Training in comparison to an established treatment for social phobia, Cognitive~     Therapy. A randomized trial was conducted in which participants were allocated to either six~     weeks of Attention Training or Cognitive Therapy. It was hypothesized that both treatments~     would be effective in reducing social phobia symptoms, but that Attention Training would work~     primarily by reducing levels of self focused attention, while Cognitive Therapy would work~     through changes to probability and threat appraisals.~   "
188796|NCT01093300|"~     In-stent restenosis (ISR) lesions are considered one of the toughest lesions that~     interventional cardiologists encounter in the drug eluting stent (DES) era. The current~     consensus in treating ISR is implantation of another DES into the restenosed segment. However~     the recent results of paclitaxel-releasing balloon catheter (PRBC) in ISR lesions have been~     very encouraging. The aim of HOST-ISR trial is to investigate the efficacy and safety of PRBC~     compared with everolimus-eluting stent (EES) in preventing neointimal growth in ISR lesions.~     HOST-ISR trial is a multicenter, open-label, prospective, randomized trial to test whether~     PRBC is non-inferior to EES in preventing neointimal growth in ISR lesions. It plans to~     enroll a total of 264 patients with ISR, randomizing the cohort 1:1 to either PRBC or EES.~     The primary endpoint will be in-segment late luminal loss at 9 months angiographical~     follow-up.~   "
188797|NCT01093287|"~     In a recent multicenter randomized controlled trial, prolonged administration of low-dose~     methylprednisolone (1mg/kg/day) initiated in early acute respiratory distress syndrome was~     associated with earlier resolution of pulmonary and extrapulmonary organ dysfunction and~     reduction in duration of mechanical ventilation and intensive care unit stay. However,~     glucocorticoids may induce serious adverse events and these adverse events might compensate~     the positive effect of prolonged methylprednisolone infusion and discourage physicians from~     treating acute respiratory distress syndrome patients with glucocorticoids. Early prediction~     of responsiveness to prolonged methylprednisolone infusion would be help to decide whether to~     continue or not prolonged methylprednisolone infusion and this could reduce the drug related~     adverse events. We project to evaluate the predictors of responsiveness to prolonged~     methylprednisolone infusion in early acute respiratory distress syndrome .~   "
188798|NCT01093274|"~     Patients intended for ambulatory colonoscopy will be randomized into 2 groups~   "
188799|NCT01093261|"~     Traumatic brained injured (TBI) patients frequently suffered from glucocorticoid~     insufficiency that is associated with a raise in the rate of pneumonia.~      In a placebo-controlled, multi-center, double-blinded trial, treatment of glucocorticoid~     insufficiency (hydrocortisone associated with fludrocortisone) will be assessed for~     prevention of post trauma pneumonia in a population of severe TBI patients.~   "
188800|NCT01093248|"~     Opioid abuse is a complex problem, which not only impacts on the affected individuals'~     physical and psychological health, but also threatens public security and the productivity of~     the society. Further, through needle sharing and sexual contacts, injecting drug users (IDUs)~     have become laden with HIV and HIV related health problems, representing a serious public~     health threat all over the world. In Taiwan, since the identification of the first~     HIV-infected IDU in 1987, the incident cases have continued to increase, reaching a height of~     2,461 in 2005. In order to contain the epidemics of HIV among IDUs, and to prevent its spread~     to the population in general, the Center for Disease Control (CDC) collaborated with the~     Department of Justice to initiate and implement a number of harm reduction programs in 2005.~     The fact that opioid addiction is officially treated as a health rather than a legal issue~     itself represents a remarkable milestone in Taiwan. Among these harm reduction programs,~     including needle and syringe exchange for IDUs as well as substitution treatment approaches~     for opioid dependence, methadone maintenance treatment (MMT) perhaps represents the most most~     important and most crucial component. Remarkably, in a relatively short time span, more than~     60 MMT programs were established, which enrolled more than 15,000 heroin addicts. This~     notwithstanding, the overall and differential effectiveness of these MMT service delivery~     systems, as well as the characteristics of these programs and the patients that might~     contribute toward treatment response or failure remain largely unknown. Such knowledge base~     is crucial for establishing standardized and feasible outcome evaluation processes for opioid~     addicts receiving MMT programs, as well as for the further improvement of the efficacy and~     effectiveness of these programs, in Taiwan.~      In order to address some of these issues, this study adopts a multi-site, prospective~     clinical follow-up design. It aims at establishing a research network for examining MMT~     outcome, developing standardized MMT outcome assessment instruments and procedures, and~     identifying predictors of MMT outcome. The findings may contribute to the better~     understanding of the characteristics of opioid addicts, the effectiveness of MMT and~     remaining service needs for opioid addicts in Taiwan.~   "
188801|NCT01093235|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin~     hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. It is not yet known whether giving combination chemotherapy together with~     or without bevacizumab is more effective in treating patients with nonmetastatic breast~     cancer.~      PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy~     works compared with giving combination chemotherapy together with bevacizumab in treating~     patients with nonmetastatic breast cancer.~   "
188802|NCT01093222|"~     This phase II trial is studying how well giving sorafenib tosylate together with erlotinib~     hydrochloride works in treating patients with locally advanced, unresectable, or metastatic~     gallbladder cancer or cholangiocarcinoma. Sorafenib tosylate and erlotinib hydrochloride may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by~     blocking blood flow to the tumor.~   "
188803|NCT01093209|"~     The purpose of this study is to determine the efficacy of the interferential laser therapy in~     the wrist and hand pain and disability reduction and force improvement in the carpal tunnel~     syndrome. Subjects are patients diagnosed of carpal tunnel syndrome who have been prescribed~     laser therapy. Settings: Ramon y Cajal Hospital. Department of Rehabilitation. Physical~     therapy unit. Electrotherapy section. Occupational Therapy. Department of Neurology.~   "
188804|NCT01093196|"~     This is a multicenter, randomized, controlled, 3 arm parallel group study designed to~     evaluate the efficacy and safety of three all-oral combinations: lenalidomide with~     dexamethasone (Rd) in comparison with lenalidomide in association with MP (MPR) and~     lenalidomide in association with cyclophosphamide - prednisone (CPR) in newly diagnosed~     symptomatic MM patients. This protocol also provides a substudy designed to observe~     asymptomatic patients excluded to the protocol that in any case could be inserted in the~     study.~   "
188805|NCT01093183|"~     This phase I/II trial studies the side effects and best dose of lenalidomide when given~     together with cyclophosphamide and to see how well they work in treating patients with~     previously treated hormone-refractory prostate cancer. Lenalidomide may stop the growth of~     prostate cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving lenalidomide together with~     cyclophosphamide may kill more tumor cells.~   "
188806|NCT01093170|"~     This is a non-randomized, open-label, dose-escalating Phase Ia study performed at a single~     center designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of~     intravitreous administration of RNA-144101 in patients with geographic atrophy (GA).~   "
188807|NCT01093157|"~     Membranous Nephropathy (MN) is an immune-mediated kidney disease that affects the glomerulus~     or the filter that removes toxins from the blood. Damage to the membrane that separates blood~     from urine results in loss of protein into the urine (proteinuria) and in some cases loss of~     kidney function.There is no standard specific treatment for MN.~      ACTH has a pronounced lipid-lowering effect in healthy individuals, in steroid-treated~     patients with renal disease and in hemodialysis patients Some studies suggest that prolonged~     synthetic ACTH therapy may represent an effective therapy in patients with idiopathic MN,~     more extensive randomized studies with longer follow-up are needed before therapeutic~     recommendations can be made.~      We propose to do a pilot study to test the hypothesis that biologic ACTH, a slow-release~     formulation of corticotropin extracted from porcine pituitary glands (H.P. Acthar gel) will~     be effective in reducing proteinuria and improving lipid profile in patients with idiopathic~     MN.~   "
188808|NCT01093144|"~     Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of~     delivery(normal vaginal delivery/instrumental delivery/Caesarean section.~   "
188809|NCT01093131|"~     The increased risk for contrast-induced nephropathy (CIN) in patients with chronic kidney~     disease (CKD) undergoing coronary angiography (CAG) has been established. Current and~     historical data on CIN prevention strategies have shown wide variation with respect to the~     optimal type, route and timing of these therapies. We investigate the role for oral hydration~     and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium~     bicarbonate in patients with CKD undergoing CAG.~   "
188810|NCT01093118|"~     The purpose of this study is to determine if a local treatment is effective for the treatment~     of toenail fungus (distal subungual onychomycosis).~   "
188812|NCT01093092|"~     This phase I trial studies the side effects and best dose of calcitriol when given with~     cisplatin and gemcitabine hydrochloride in treating patients with advanced solid tumors that~     cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin and gemcitabine~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Calcitriol may stop the growth of tumor cells by~     blocking blood flow to the tumor. Calcitriol may also help cisplatin and gemcitabine~     hydrochloride kill more tumor cells by making them more sensitive to the drug.~   "
188813|NCT01093079|"~     Partial Nephrectomy is the standard care for small (<4 cm) renal tumors. Despite the~     expanding use of laparoscopic approach, debate exist regarding the short and long term~     outcomes compared to the open approach. Our goal is to perform a prospective randomized trial~     to compare these methods~   "
188814|NCT01093066|"~     Radical cystectomy is the treatment of choice for bladder infiltrative urothelium carcinoma.~     But the removal of the bladder reservoir has a major impact of the Quality of life.~     Neoadjuvant chemotherapy has been shown to be associated with an absolute 5% survival~     benefit. Two monocentric studies suggest that this neoadjuvant chemotherapy could be used in~     combination with an optimal transurethral bladder resection, in a strategy of bladder~     preservation, provided a complete response being obtained (about 50% in every trial using~     neoadjuvant MVAC protocol before a radical cystectomy). In those both studies with patients~     T2 to T4, the 5 years overall survival is above 65%, with more than 40% bladder preservation~     rate at 5 years.~      The feasibility and the efficacy of such an attitude in a multicentric trail using the most~     active regimen (in term of complete response in metastatic patients) is unknown. The chosen~     regimen is therefore the intensified MVAC which allows, with the use of G-CSF, to double the~     dose-intensity of Adriamycin and Cisplatinum, and to decrease by 30% the methotrexate and~     vinblastine dose-intensity.~      The efficacy and safety confirmation of such an approach could lead to consider it in~     patients motivated to retain a functional bladder.~   "
188815|NCT01093053|"~     The purpose of this study is to determine whether participation in mind-body skills groups by~     veterans who have experienced a stressful war-related situation and have symptoms of~     posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety,~     reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a~     positive change that people can experience when they have been in a traumatic situation).~   "
188816|NCT01093040|"~     To assess the safety of the administration of the drug (CAT-354) in healthy Japanese~     subjects.~   "
188817|NCT01093027|"~     To determine the effects of upper limb forearm cooling on Essential Tremor upper limb tremor~     using a more practical method of limb cooling through a forearm cold pack.~   "
188818|NCT01093014|"~     The loss of muscle contraction (paralysis) removes an important stimulus for maintenance of~     overall health for individuals with complete spinal cord injury (SCI). Increased protein~     catabolism (atrophy) limits important stresses to the skeletal system. Bone loss doubles the~     risk of fracture and contributes to increased mortality in Veterans with SCI. Metabolic~     syndrome and diabetes lead to heart disease in Veterans with SCI at higher rates than the~     general population. Exercise methods to sustain muscle tissue, bone density, and metabolic~     stability after SCI are lacking scientific justification. If left unchecked, the secondary~     complications of SCI can be health limiting or even life threatening to Veterans with~     paralysis. The importance of maintaining the health of the musculoskeletal system after SCI~     has never been greater as a cure for paralysis may become a reality. Contemporary~     rehabilitation interventions lack the ability to functionally load muscle tissue, quantify~     the dose of load, stress the cardiovascular system, monitor the overall stresses during daily~     exercise training, or offer portability to improve compliance with the exercise. The~     long-term goal of this project is to establish the optimal dose of muscle and bone stress~     during functional exercise in order to improve the health of Veterans with complete~     paralysis. The practical outcome of this research is to offer a form of activity that is~     feasible, portable, and grounded in sound scientific principles. The scientific goal is to~     understand whether the dose of force generated in paralyzed muscle via evoked contractions is~     critical to muscle atrophy/hypertrophy molecular pathways, physiologic performance, and~     insulin sensitivity. The investigators will administer various doses of muscle force by~     manipulating the frequency of electrical stimulation while keeping stimulation current (i.e.~     muscle fiber recruitment) constant. Interestingly, no previous study has examined the dose of~     muscle force necessary to trigger adaptations in protein synthesis/degradation pathways. The~     investigators wish to discover the most effective method to maintain the molecular and~     physiologic properties of paralyzed muscle. The investigators believe such a method will be~     in urgent demand as a co-intervention with pharmaceutical strategies in post-SCI~     rehabilitation.~   "
188819|NCT01093001|"~     The effect of cardiac pacing leads on tricuspid regurgitation is unclear. This study will~     determine whether using a smaller diameter leads and an alternate position in the ventricle,~     the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the~     apex.~   "
188820|NCT01092988|"~     The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid~     using the ExAblate 2000 system was performed in 2001. Since then, more than 5000 treatments~     were done in more than 60 different hospitals around the world. The experience accumulated in~     this novel treatment was collected by InSightec and implemented into software and hardware~     updates, clinical tips and guidelines, all aimed to improve the clinical results and their~     durability, while maintaining a high level of safety.~      Based on extensive clinical experience and our internal research and development effort goals~     toward continuous improvement in ExAblate treatment safety and performance, limited changes~     have been made to the current ExAblate system. This modified ExAblate system version is~     designated as the ExAblate 2100 UF V2 system.~      The modifications are believed to improve system's friendliness to the user, without~     introducing new risks or other issues of safety of the device, and should not have any~     negative impact on the safety or technical efficacy of the treatments for patients.~   "
188821|NCT01092975|"~     The purpose of this study is to determine if applying the drug phenylephrine to the inside of~     the mouth can be done safely and is tolerable to use in cancer patients receiving radiation~     to the Sub-mandibular lymph nodes.~   "
188822|NCT01092962|"~     Idiopathic nephrotic syndrome is steroid-sensitive in more than 90% of cases in children.~     However 60% of cases are steroid dependent and required treatment with immunosuppressive~     agent. Cyclophosphamide and ciclosporin are used for long time to reduce steroid dependency,~     but duration of these treatments should be restricted because of gonadotoxicity for~     cyclophosphamide and nephrotoxicity for ciclosporin.~      Mycophenolate mofetil appears as an alternative treatment without gonadotoxicity and~     nephrotoxicity. However, contrary to cyclophosphamide, mycophenolate mofetil does not seem to~     have a residual action so that treatment must be maintained during months or years.~      The aim of the study is to compare efficacy of cyclophosphamide and mycophenolate mofetil in~     steroid dependent nephrotic syndrome in children.~   "
188823|NCT01092949|"~     To evaluate the feasibility of functional MRI method developed in an animal model and to~     construct normal reference ranges for in vivo placental perfusion using functional MRI. This~     will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16~     to 32 weeks' for fetal reason in a tertiary referral center.~   "
188824|NCT01092936|"~     The present study is part of an international program and deals with the translation and~     validation program for the Italian version of the MDS-UPDRS.~      The program will be articulated in three steps:~        -  Phase I: translation and back-translation of the MDS-UPDRS in Italian (completed)~        -  Phase II: Cognitive testing. This step is aimed at a preliminary testing of a subset of~          potentially culturally sensitive items in a limited set of PD patients (approximately~          10). Should this phase identify issues in the understanding and ease of use of some~          items a revised translation of some individual items might be envisaged.~        -  Phase III: large validation testing: this phase will involve 350 PD patients from 12-14~          Italian PD centres.~      The IRIS protocol deals with phase II and III of the program.~   "
188825|NCT01092923|"~     Nitrous oxide is the oldest anaesthetic agent still in routine use today. Despite huge~     changes in the pharmacology of volatile anaesthetic agents and intravenous anaesthetics, the~     unique properties of nitrous oxide have maintained its place in modern practice, where it is~     used in combination with other, more powerful inhaled agents, such as sevoflurane. It has~     useful analgesic properties, unlike the other agents used today, and its inclusion reduces~     the concentration of other agents required to maintain an adequate depth of anaesthesia for~     surgery.~      In particular, its low solubility in body tissues gives it a unique pharmacokinetic profile,~     with rapid washin and washout from the body. It has been shown to have a similar effect on~     the speed of uptake of accompanying agents like sevoflurane (the second gas effect), which~     have much slower pharmacokinetics. A recent study by us suggested that this promotes faster~     and smoother onset of anaesthesia, as measured using the standard monitor of depth of~     anaesthesia (the BIS monitor). This finding requires confirmation prospectively in a larger~     group of patients. The investigators further hypothesise that a similar effect also exists on~     washout of sevoflurane at the end of the procedure, promoting quicker recovery (emergence)~     from anaesthesia. This has never been previously demonstrated. This information will help~     better define the place of nitrous oxide in achieving optimal outcomes in modern anaesthetic~     practice. The investigators propose to conduct a simple study to measure the effects of~     nitrous oxide washin and washout on exhaled concentrations of accompanying sevoflurane during~     both induction of anaesthesia and emergence, and identify any accompanying effect on the rate~     of change in depth of anaesthesia using BIS. The investigators hypothesise that the rate of~     fall of exhaled sevoflurane concentration at the end of anaesthesia will be more rapid in the~     group of patients breathing a gas mixture containing nitrous oxide, and that the rate of fall~     of BIS on induction and the rate of rise of BIS on emergence will be faster in the nitrous~     oxide group.~   "
188826|NCT01092910|"~     To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in~     subjects suffering from mild to severe hearing loss.~   "
188827|NCT01092897|"~     The purpose of the study is to determine whether circulating molecular and cellular~     biomarkers are predictive of imatinib effect on pulmonary artery hypertension.~   "
188828|NCT01092884|"~     We will assess whether oral supplementation with Polypodium leucotomos, a commercially~     marketed fern extract, improves facial melasma in Hispanic women with moderate to severe~     melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium~     leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus~     topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium~     leucotomos group will have more improvement in their melasma compared to the placebo group.~   "
188829|NCT01092858|"~     The design of the study is a standard double-blind design, which is needed in this study to~     allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of~     testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in~     comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks,~     to monitor the increase as well as the steady state of the parameters assessed.~   "
188830|NCT01092845|"~     PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats,~     which suggests that PF-04457845 is active in rat's brains. This study is designed to see~     whether this is also the case in man.~   "
188831|NCT01092832|"~     The purpose of this study is to determine whether voriconazole is safe and effective for the~     treatment of serious Candida infection and Candida infection of the esophagus in children and~     adolescents.~   "
188832|NCT01092819|"~     Current literature has only limited information on the natural history of acute ischemic~     stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from~     symptom onset, particularly on 90 day functional outcome as defined by the mRS. Data from~     this trial will advance our knowledge on this important topic and may serve as a bench mark~     for future trials~   "
188833|NCT01092806|"~     One of the main side-effects of tacrolimus in solid organ transplanted patients is post~     transplant diabetes mellitus (PTDM). It is not known if different pharmacokinetic properties~     influence the risk of developing PTDM. It is possible that it either is high peak~     concentrations of high overall systemic exponation that is responsible for the effect on~     insulin secretion. With the new slow-release formulation of tacrolimus (Advagraf) a different~     pharmacokinetic profile is introduced to patients and it is of interest to investigate if~     this affects insulin secretion and insulin sensitivity of patients.~      Hypothesis: The pharmacokinetic profile of tacrolimus affects the insulin secretion in renal~     transplant recipients.~   "
188834|NCT01092793|"~     Atherosclerotic coronary heart disease is a condition thought to involve low-grade~     inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of~     fish oil may be beneficial in attenuating the inflammatory process. Still, however, there are~     lacking data in respect to whether differences in composition of various marine oils may~     influence the inflammatory status differently.~      The hypothesis of the current study is that extract from the antarctic krill (Euphausia~     superba) is better than traditional fish oils when compared head-to-head with balanced~     composition of omega 3 content on inflammatory status.~   "
188835|NCT01092780|"~     This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime~     sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS)~     who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy.~     The goal of this study is to determine the effect of MK-7288 after single dose administration~     on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests,~     and on driving performance as measured by standard deviation of lane position in simulated~     driving (country vigilance driving).~   "
188854|NCT01092533|"~     The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of~     enteric-coated mycophenolate sodium (Myfortic®) in combination with low-dose corticosteroids~     (Decortin H®) compared to a monotherapy with low-dose corticosteroids (Decortin H®) in~     subjects with chronic intraocular inflammation (non-infectious intermediate uveitis).~   "
188836|NCT01092767|"~     The purpose of this study is to determine if the Valiant stent graft is safe and effective in~     treating patients who have a blunt thoracic aortic injury (BTAI). BTAI is when the aorta has~     been injured due to traumatic force to the chest area. It is commonly caused by motor vehicle~     accidents. In most cases it is life threatening and the standard treatment is surgery. Many~     times when a person has a BTAI they also have other injuries that can affect the results of~     the surgery.~      Since stent grafting has been an effective way to treat other aortic conditions such as~     aneurysms (bulge in aorta wall), it is believed that the Valiant stent graft would be~     effective in treating BTAI. A stent graft is a woven polyester tube (graft) supported by a~     metal frame of strong but flexible nitinol (type of metal) springs (stent) that is placed in~     the aorta to help seal the injury and keep it from bleeding.~   "
188837|NCT01092754|"~     The objective of this study is to characterize the safety, efficacy and pharmacokinetic~     profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient~     population.~   "
188838|NCT01092741|"~     Objectives:~      Primary endpoints:~      To achieve low levels of Polymerase Chain Reaction (PCR) ratios of B-cell antigen receptor~     (Bcr-Abl)/Bcr (molecular CR) in a significant proportion of patients after 12 months of~     higher doses (800 mg daily) of Gleevec therapy To increase the proportion of patients~     achieving a complete cytogenetic response in patients with Ph-positive chronic phase CML~     using initial higher dose Gleevec therapy.~      Secondary endpoints:~      To evaluate the durations of PCR negativity, cytogenetic response, hematologic control, and~     survival.~      To analyze differences in response rates and in prognosis within different risk groups and~     patient characteristics~   "
188839|NCT01092728|"~     The goal of this clinical research study is to compare how the drug Sprycel (dasatinib) can~     help to control the tumor in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged~     Melanoma. The safety of this drug will also be studied.~      Objectives:~      Primary Objectives:~      1. To compare the biological response of tumors With and Without Resectable Tumors from~     patients with acral, or mucosal melanomas after treatment with dasatinib.~      Secondary Objectives:~        1. To assess the safety and tolerability of dasatinib in this patient population~           Completely Resectable Acral, Chronic Sun-damaged (CSD), and Mucosal Melanoma:~        2. To assess the median time to recurrence and overall survival of patients with completely~          resectable acral, CSD, and mucosal melanoma treated with dasatinib~        3. To assess whether FDG-avidity and KIT phosphorylation responses after treatment with~          dasatinib predicts prolonged time to recurrence and/or overall survival in patients with~          completely resectable acral, CSD, and mucosal melanomas~           Not Completely Resectable Acral, CSD, and Mucosal Melanoma:~        4. To assess the response rate, progression free survival, and overall survival of patients~          with acral, CSD, and mucosal melanoma treated with dasatinib~        5. To assess whether FDG-avidity and KIT phosphorylation responses after treatment with~          dasatinib predicts response rate, progression free survival, and/or overall survival in~          patients with acral, CSD, and mucosal melanomas~   "
188840|NCT01092715|"~     Neck pain is a common problem in our society, accounting for 20% of all chiropractic visits.~     Physical therapy interventions for chronic neck pain have been chosen based on the patient's~     symptoms and examination findings. These interventions include superficial and deep heat,~     massage, traction, manual therapy, and exercise programs. There is little controlled research~     addressing the efficacy of these therapies. Although many of these interventions provide some~     patients with pain relief and increased function, studies often utilize multiple~     interventions on the same subject such as heat, ultrasound, cervical traction, range of~     motion exercises, making interpretation of the results difficult. Much of the literature to~     date has focused on studies of subjects suffering from acute neck pain. Many of these studies~     suggest that subjects report decreased pain, decreased disability and increased cervical~     spine active range of motion. There are no controlled studies comparing the effects of spinal~     mobilization and standard physical therapy on subjects with chronic neck pain. The object of~     this study is two fold: 1) to determine the score variability of two neck disability~     questionnaires )both baseline and change scores) to be used in sample size calculations, and~     2) to establish the ability to recruit, treat and follow sufficient numbers of subjects~     needed for a full clinical trial. The ability to predict outcomes of neck pain treatment will~     lead to more appropriate therapies and an avoidance of unnecessary treatments.~   "
188841|NCT01092702|"~     The goal of this proposal is to explore the potential effectiveness of varenicline to treat~     tobacco dependence among recovering alcoholic smokers who, as a group, are at high risk for~     tobacco-caused morbidity and mortality. In this open-label phase II clinical trial, we are~     proposing to enroll 32 recovering alcoholic smokers who are motivated to stop smoking. After~     the initial up titration of varenicline in week 1, all 32 subjects will receive a total of 2~     mg/day of varenicline for 12 weeks. In addition to receiving varenicline, all subjects will~     receive brief behavioral counseling and our standard intervention at each visit during~     participation in the study.~   "
188842|NCT01092689|"~     We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic~     cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived~     carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly~     sensitive technology to determine if this carcinogen binds to DNA in the pancreas.~   "
188843|NCT01092676|"~     Ankle sprains are common in children, and optimal pain management has not been determined.~      We hypothesize that children age 7-17 years of age with acute ankle sprain randomized to~     receive regular dose ibuprofen will show a greater improvement in degree of~     pain,disability,swelling and tenderness four days following injury as compared to children~     who take ibuprofen only intermittently for pain relief during the same time period.~   "
188844|NCT01092663|"~     This study will assess the effects of colesevelam, alone or in combination with sitagliptin,~     on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise~   "
188852|NCT01092559|"~     This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and~     device performance of the GeNO nitrosyl delivery system during right heart catheterization~     (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will~     receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula.~     Hemodynamics, clinical laboratory and clinical assessment data will be collected on all~     participants to evaluate safety.~   "
188845|NCT01092650|"~     The purpose of this research study is to better understand how people respond to~     cancer-causing chemicals in cigarette smoke. Some people are able to get rid of these~     chemicals as harmless agents while others suffer damage to their cells that can ultimately~     result in cancer. We hope to develop a better understanding of how we can identify the people~     who are in danger of getting cancer. Participants will complete questionnaires regarding~     their health and smoking history. We will take blood samples to look at genes which determine~     how the body breaks down some tobacco-related toxins. Participants will be given a small~     amount of liquid to drink, containing alcohol, water, and a compound called deuterated~     phenanthrene (DP), which is found in cigarette smoke and in the environment. Phenanthrene is~     non-toxic and does not cause cancer, but this compound is broken down by the body in the same~     way as cancer-causing agents. We will follow the pathway of this compound as it is broken~     down in the body.~   "
188846|NCT01092637|"~     The aim of this study is to determine the efficacy of therapeutic hypothermia following~     perinatal asphyxia on neurological and neuropsychological outcomes and also to assess~     academic attainment and any additional health, societal or educational costs associated with~     changes in outcome as a result of the intervention. This study will determine whether the~     apparent initial benefits of cooling are maintained in the longer term.~      Perinatal asphyxia (a lack of oxygen occurring around the time of birth) may have long term~     consequences on brain functioning, which may be altered by treatment with hypothermia~     (cooling). Currently, there is no information on the effect of cooling on outcome beyond 18~     months of age. We intend to assess at 6 - 7 years of age, the children that participated in~     the TOBY trial of whole body cooling following perinatal asphyxia and compare between the~     children that had received the cooling treatment soon after birth and those that were not~     treated with cooling, the number that survived with an intelligence quotient (IQ) greater~     than 84, the presence and severity of disabilities, educational attainment and the economic~     impact on families and service providers. If possible, children will be assessed in their~     school, with the option of alternative venues such as home or clinic if required.~      During the assessment a paediatrician will conduct a neurological examination. A psychologist~     will administer psychometric tests to evaluate cognitive, behavioural and motor development.~     Questionnaires completed by parents and teachers will complete the data collection. Economic~     factors will also be assessed in the parent questionnaire.~      Each child will have contact with the assessors during one school day with appropriate~     breaks. Assessments will take place over a period of 3 years.~   "
188847|NCT01092624|"~     This study will evaluate the effect of pessary therapy, with and without Solifenacin~     (Vesicare), on symptoms of over active bladder and bladder function in women with overactive~     bladder symptoms and pelvic organ prolapse.~      Study Hypotheses:~      Null hypothesis, HO: Reduction of anterior vaginal wall prolapse and treatment with~     solifenacin does not improve overactive bladder symptoms more than reduction of anterior~     vaginal wall prolapse and placebo.~      Alternate hypothesis, HA: Reduction of anterior vaginal wall prolapse and treatment with~     solifenacin does improve overactive bladder symptoms more than reduction of anterior vaginal~     wall prolapse and placebo.~   "
188848|NCT01092611|"~     The purpose of this long-term follow-up study is to assess the long-term health status of~     HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the~     investigational HIV vaccine 732462. This study will provide additional data concerning the~     long-term benefits/risks associated with vaccination.~      No vaccine will be administered during the study period. Vaccines were administered during~     the primary studies.~   "
188849|NCT01092598|"~     Older adults with schizophrenia are a growing segment of the population yet their physical~     health status is poor. In order to design effective interventions, the contributing factors~     must be understood. Current data suggest the side effects of psychiatric medications,~     sociodemographic factors, and health care disparities are a few of the reasons for the poor~     physical health. There are only limited data on the impact of psychiatric symptomatology and~     neurocognition on the physical health of this population. These limited data indicate that~     worse symptomatology and poorer neurocognition may negatively impact physical functioning, a~     critical component to optimal physical health. The purpose of this pilot study is to begin to~     fill this knowledge gap by: 1. examining the relationship between neurocognitive function and~     physical function and 2. Examining the relationship between schizophrenia symptoms and~     physical function. 3. Examining the relationship between serum Brain Derived Neurotrophic~     Factor (BDNF) and physical function. Using a descriptive correlational design, 50 older~     adults (55+) with schizophrenia or schizoaffective disorder will be assessed. Bivariate~     associations will be used to examine the relationship between key variables including~     schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS),~     neurocognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB),~     Physical Function as measured objectively by the Timed Get Up and Go (TGUG) test and~     subjectively with the physical component summary subscale of the 12-item short form health~     survey (SF-12), and serum BDNF. These pilot data will lay the foundation for a future health~     promoting intervention.~   "
188850|NCT01092585|"~     Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is~     being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line~     therapy to patients with advanced melanoma and normal serum lactate dehydrogenase (LDH).~   "
188851|NCT01092572|"~     Cystic fibrosis (CF) is a lethal genetic condition that affects 30,000 children and adults in~     the United States. Although CF management has improved substantially over the past two~     decades, there is still no cure and most patients with CF die before reaching their 50th~     birthday, largely due to lung failure. There is growing evidence that excess lung and blood~     inflammation that occurs in response to infections in the lungs cause CF patients to be~     sicker. Simvastatin is a drug that is used to lower cholesterol, but many researchers have~     found that this drug may also treat blood and lung inflammation. In this study, we will~     determine whether or not simvastatin can treat blood and lung inflammation in patients with~     CF and most importantly determine whether or not it can make these patients feel better and~     have better lung function.~   "
188853|NCT01092546|"~     To determine the level of association between the quantitative estimates of brain uptake of~     [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of~     amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement~     for NPH.~   "
188855|NCT01092520|"~     Children with healing burns often suffer from pruritus that may continue for many months.~     Pruritus can be very distressing to the child and can interfere with sleep, activities of~     daily living, and rehabilitation therapy. Additionally, constant scratching of skin grafts~     may result in damage that requires further surgery, thus putting the patient at additional~     risk and adding to health care costs. Although the size of the burn injury is a risk factor~     for pruritus, almost 50% of patients with small burn injuries reported moderate or severe~     pruritus.~   "
188856|NCT01092507|"~     The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric~     virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in~     infants and toddlers.~      Primary Objective:~        -  To demonstrate the non-inferiority of the antibody response 28 days after vaccine~          administration of one dose of JE CV (administered on Day 0) compared to the antibody~          response after one dose of the SA14-14-2 control vaccine (administered on Day 0).~      Secondary Objectives:~        -  To describe the immune response to JE in both vaccine groups in JE-CV virus and~          SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2~          vaccine~        -  To describe the safety profile in all vaccinated subjects up to 28 days and all serious~          adverse events (SAEs) up to 6 months after vaccination.~        -  To describe only related SAEs and all death from 6 month to 12-month follow-up.~   "
188857|NCT01092494|"~     Ovarian endometriotic cyst (endometrioma) is one of the most common endometriotic lesions,~     and conservative laparoscopic surgery is the treatment of choice. However, the recurrence~     after surgery is common.~      As repetitive surgery leads to morbidities and ovarian function decrease, recurrence after~     surgery frustrates both patients and clinicians. In this aspect, medical treatments have been~     offered after surgery to prevent or delay the recurrence. Gonadotropin-releasing hormone~     agonist (GnRHa) is frequently used in women with advanced endometriosis, but the efficacy is~     rather controversial. On the other hand, it has been demonstrated that oral contraceptives~     (OCs) could reduce or delay endometrioma recurrence, but data are still limited.~     Consequently, no one type of postoperative medical therapy has been shown to be superior in~     reducing the recurrence of endometrioma.~      The rationale of postoperative medical therapy is that it could eradicate microscopic lesions~     which were not found and not treated sufficiently during surgery. Therefore, the maintenance~     of strongly suppressed condition induced by postoperative GnRHa treatment by addition of OCs~     could be a promising treatment to prevent the recurrence, but it has not been widely~     investigated.~      We performed this retrospective cohort study to evaluate the efficacy of cyclic monophasic~     low-dose OCs as a maintenance therapy after GnRHa treatment for the suppression of~     endometrioma recurrence.~   "
188858|NCT01092481|"~     This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified~     FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6~     or CAPOX treatment in terms of disease free survival in patients with stage II/III colon~     cancer.~   "
188859|NCT01092468|"~     This study is to compare the efficacy of Harmonic Scalpel with conventional diathermy~     technique in terms of reducing elevation time and perioperative complications of perforator~     flaps for head and neck reconstruction.~   "
188860|NCT01092455|"~     The purpose of this study is to determine whether the use of Citrasate®, citric acid~     dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing~     hemodialysis.~   "
188861|NCT01092442|"~     The purpose of this study is to collect long-term follow-up data of the CryoValve SG~     Pulmonary Human Heart Valve.~   "
188862|NCT01092429|"~     Development of myocardial ischemia, and/or myocarditis would induce different changes in~     myocardial contraction behavior pattern,which maybe very subtle, and may not be detected by~     the 2D and m-mode echocardiography examinations. According to tissue Doppler imaging(TDI),~     they can be depicted by different models of echo with higher frame rates. In addition, many~     studies using TDI have significantly contributed of efforts to evaluate systolic and~     diastolic function and prognosis.~      This study assess the value of the indices of left ventricular function obtained by using TDI~     in patient with coronary artery disease(CAD). We hypothesized that TDI will add incremental~     value for regional wall motion abnormality of CAD and its prognosis.~   "
188863|NCT01092416|"~     This is a prospective, single-arm, multi-center study to evaluate the safety and performance~     of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study~     is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety~     endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects~     will be treated with the orbital atherectomy system and adjunctive stent. All subjects will~     be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call~     or clinical follow up at each anniversary until study is closed.~   "
188864|NCT01092403|"~     The study will assess the safety, tolerability and clinical activity of ASM-024 in subjects~     with mild allergic asthma.~   "
188865|NCT01092390|"~     In this application the investigators describe plans for a randomized controlled cross-over~     trial to determine the effects of omega-3 fatty acid supplementation on urine protein~     excretion in 30 adults with diabetes (NIDDM) and kidney disease defined by the presence of~     proteinuria.~   "
188866|NCT01092377|"~     The aim of this study is to determine if providing iron and a mixture of DHA and EPA, alone~     and in combination, to children with iron deficiency and poor n-3 fatty acid intake will~     improve their cognitive performance, activity levels and immune system.~      Additionally, the effects on iron and fatty acid status, and gut microbiota, will be~     assessed.~   "
188867|NCT01092364|"~     Weight gain accelerates during early adulthood, and leads to the health consequences of~     obesity (high blood pressure, diabetes, heart disease, etc). Most weight loss studies enroll~     middle-aged adults. This study tests the hypothesis that a weight loss intervention that~     builds on prior research evidence but is enhanced with technological innovations will lead to~     weight loss in a diverse group of overweight and obese adults aged 18-35 years. The~     technology intervention, using cell phone applications, will be compared to an advice only~     control group and to a group receiving a more traditional personal coaching intervention.~   "
189147|NCT01088711|"~     This study will test the safety and tolerability of omarigliptin. It is hypothesized that~     administration of once-weekly omarigliptin in obese but otherwise healthy participants, and~     in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated~     to permit continued clinical investigation.~   "
188868|NCT01092351|"~     The study aims to investigate bacteriological efficacy of a nitrofurantoin formulation given~     twice daily for seven days in the treatment of adult patients with microbiologically~     confirmed uncomplicated urinary tract infection.~      Additional study objectives are to evaluate clinical efficacy as well as safety and~     tolerability of the nitrofurantoin formulation.~   "
188869|NCT01092338|"~     Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune~     function, growth, muscle, bone, and inflammatory status in children, adolescents and adults~     with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy~     using clinically important outcomes, and this will overcome the critical barrier for use of~     vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit~     D supplementation may prove to be an effective and feasible treatment for symptoms and~     prevention of side effects for people of all ages living with HIV/AIDS in the US and around~     the world.~   "
188870|NCT01092325|"~     A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure~   "
188871|NCT01092312|"~     The purpose of this study is to determine whether the percentage cases which have ideal~     mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting~     blocks is higher than those without the use of Signature when measured immediately~     post-operatively.~   "
188872|NCT01092299|"~     Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different~     Extended/modified-release formulations and one immediate release formulation of AZD1446. In~     addition the food effect on AZD1446 pharmacokinetics will be investigated.~      Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in~     elderly healthy volunteers.~   "
188873|NCT01092286|"~     The goal of the study is to determine effect of coach-led neuromuscular warm-up on~     non-contact, lower extremity (LE) injury rates among female athletes in a predominantly~     non-white public high school system. The investigators hypothesized the warm-up would reduce~     non-contact LE injuries.~   "
188874|NCT01092273|"~     Bimatoprost has been shown to provide effective IOP lowering in patients of all races.~     Conversely, travoprost has been shown to be more effective in black patients than in~     Caucasians in some studies. However, Noecker et al 2004 compared bimatoprost with travoprost~     in African-Americans with glaucoma or OHT, and found that bimatoprost was more likely than~     travoprost to achieve target pressure at 3 months.~      These racial differences in efficacy of these medications warrant further investigations. The~     investigators study aim to compare the IOP-lowering efficacies of bimatoprost and travoprost~     in an Egyptian population with primary open-angle glaucoma (OAG) or ocular hypertension~     (OHT).~   "
188875|NCT01092260|"~     The purpose of this study is to validate a feasible, safe and reliable iohexol plasma~     clearance method in routine monitoring of the renal function (GFR) in children.~      Different parameters of renal function will be compared to the gold standard multiple sample~     points procedure of iohexol clearance.~   "
188876|NCT01092247|"~     The aim of the study is, to study the efficacy of the ketogenic diet in delaying or~     preventing recurrence and tumor growth progression of patients who have been previously~     treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors.~      It will be an open-label trial of nutritional intervention for up to 1 year. An interim~     analysis of the data will be carried out to assess safety, compliance and efficacy of the~     diet. This will be reviewed by both SHS and the Clinical trial team.~   "
188877|NCT01092234|"~     The trial is designed to evaluate the effectiveness of a newly established Observational unit~     at St. Olavs Hospital in terms of readmission rates, compared to the provision of care in~     normal/traditional units for defined diagnosis and medical problems.~   "
188878|NCT01092221|"~     The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo,~     as add-on to mood stabilizers and/or antipsychotic in the treatment of patients with bipolar~     disorder, in a manic episode.~   "
188879|NCT01092208|"~     Background:~        -  Researchers who are studying autism spectrum disorders are interested in developing a~          collection of research samples from both children with autism and healthy individuals,~          some of whom may be related to the children with autism.~        -  The genetic condition tuberous sclerosis, which can cause the growth of benign tumors in~          the brain and other parts of the body, is also linked with autism. Researchers have been~          able to determine the specific genetic mutations involved in tuberous sclerosis, and as~          a result are interested in studying the genetic information of children who have both~          tuberous sclerosis and autism, as well as tuberous sclerosis without autism.~      Objectives:~      - To develop a collection of DNA samples from blood and skin samples taken from children with~     autism and/or tuberous sclerosis, as well as healthy volunteers.~      Eligibility:~        -  Children between 4 to 18 years of age who have autism and/or tuberous sclerosis, or are~          healthy volunteers.~        -  Some of the healthy volunteers will be siblings of children with autism.~      Design:~        -  Participants will be screened with a medical history and a physical examination, and may~          also have a genetic evaluation.~        -  Participants will provide a blood sample and a skin biopsy for further study.~        -  No treatment will be provided as part of this protocol.~   "
188880|NCT01092195|"~     Background:~        -  Gardasil , a recently approved vaccine for the sexually transmitted human papillomavirus~          (HPV), provides immunity to four types of HPV that are associated with genital warts and~          cervical, vaginal, and vulvar precancer and cancer. The vaccine has been shown to be~          highly effective in preventing infection with these HPV types and was approved for use~          by the Food and Drug Administration.~        -  More research is needed about the vaccine s ability to induce immunity in individuals~          with suppressed immune systems, such as those who have had other kinds of cancer~          treatment such as stem cell transplant. Genital warts, precancer, and cancer have been~          reported as a late complication after stem cell transplant. Researchers are interested~          in determining whether the HPV vaccine is safe to give and able to induce immunity in~          female stem cell transplant recipients, their female donors, and healthy female~          volunteers.~      Objectives:~      - To assess the safety and immune response of the HPV vaccine in female recipients of stem~     cell transplants who are either off or on stable doses of immunosuppression.~      Eligibility:~        -  Females between 18 and 50 years of age who have had allogenic stem cell transplants.~        -  Healthy female volunteers, including stem cell donors, are also eligible for this study.~      Design:~        -  Participants will be screened with a physical examination, blood and urine tests, and~          saliva samples, and will be asked to complete a sexual quality of life questionnaire.~        -  Sexually active participants will also have a routine gynecologic evaluation.~        -  Participants will receive three HPV vaccinations according to the standard vaccination~          schedule (with the second and third following 2 and 6 months after the first).~          Participants will record their daily temperature and any reactions to the vaccine on a~          vaccine report card for 1 week after each vaccination.~        -  Participants will have clinic visits for further testing 2, 6, 7, and 12 months after~          receiving the first HPV vaccine.~   "
188881|NCT01092182|"~     Background:~        -  Burkitt lymphoma/leukemia (BL) is highly treatable, but most of the standard therapies~          require multiple doses of intensive chemotherapy that may require long hospital stays~          and frequently have severe side effects. In addition, BL is a fairly common type of~          cancer in patients who also have human immunodeficiency virus (HIV), but treatment~          outcomes are poor because standard treatments do not work very well in HIV-positive~          patients and the more intense treatment regimens are highly toxic. New approaches are~          needed that expand the ways to treat BL with the same efficiency but with reduced side~          effects.~        -  DA-EPOCH-R is a standard chemotherapy treatment that consists of the drugs etoposide,~          prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. It may be able to~          treat BL with similar effectiveness but with fewer side effects. Researchers are~          interested in confirming the results of previous studies that investigated the~          effectiveness of DA-EPOCH-R in treating BL.~      Objectives:~      - To determine the safety and effectiveness of DA-EPOCH-R in treating Burkitt lymphoma.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with Burkitt lymphoma and have~     not had any prior chemotherapy treatments.~      Design:~        -  Individuals will have a series of blood and other tests to determine their suitability~          for participating in the study. Eligible participants will be divided into high-risk and~          low-risk groups based on their disease prognosis and the possibility that the BL may or~          already has spread into the central nervous system.~        -  Participants will receive intravenous infusion of the six chemotherapy drugs in~          DA-EPOCH-R in 21-day treatment cycles. The exact doses will be adjusted depending on~          participants white blood cell counts and other tests.~        -  High-risk participants will receive six cycles of DA-EPOCH-R. To treat BL that may have~          entered the central nervous system, high-risk participants will also receive infusions~          of other chemotherapy drugs into their spinal fluid.~        -  Low-risk participants will receive up to six cycles of DA-EPOCH-R, with an additional~          dose of rituximab during each cycle.~        -  Frequent blood and urine tests will be performed during treatment, as well as body~          imaging scans and other tests of cancer progression as directed by the study doctors.~          Participants will receive additional medicines to help prevent possible adverse side~          effects of DA-EPOCH-R.~        -  Participants who respond successfully to the treatment will be asked to return for~          follow-up exams every 3 months for the first 18 months, then every year for the next 3~          years. Participants who do not respond successfully to the treatment will be given the~          opportunity to participate in additional research and treatment protocols, if any are~          available.~   "
188882|NCT01092169|"~     Sickle cell nephropathy is a known complication of sickle cell anemia (SCA) manifested by~     increase in glomerular filtration rate (glomerular hyperfiltration) and results in~     proteinuria and chronic renal failure.~      Our goal is to examine the prevalence of proteinuria and microalbuminuria as an early~     predictive factor of glomerular injury, among young people who suffer from SCA as well as~     those who suffer from combined sickle cell/beta-thalassemia.~   "
188883|NCT01092156|"~     This study is a randomized controlled trial to evaluate the effectiveness of different~     approaches to prenatal teaching of infant latch.~   "
188884|NCT01092143|"~     This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in~     patients with asthma who do not take inhaled corticosteroids.~   "
188885|NCT01092130|"~     The renin-angiotensin system (RAS) is a regulatory system that plays an essential role in~     patients with chronic heart failure (CHF). Plasma renin activity (PRA) is a strong and~     independent predictor of outcome, also in the presence of ACE inhibitors (ACE-i) and/or~     angiotensin receptor blockers (ARBs). Recently, it has been shown that vitamin D regulates~     renin transcription by activating the vitamin D receptor (VDR). Thus, specific activation of~     the VDR represents a novel target for therapeutic intervention in CHF. Currently, clinical~     data are lacking. The investigators aim to investigate the effect of the administration of~     vitamin D in patients with CHF.~   "
188886|NCT01092117|"~     The primary objectives of this study are to determine whether the Ovation Abdominal Stent~     Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in~     those patients considered to be suitable candidates for open surgical repair.~   "
188887|NCT01092104|"~     A double-blind, randomized, placebo-controlled, dose-escalating study to assess the antiviral~     activity, safety, tolerability, and pharmacokinetics (PK) of the CCR5 antagonist TBR 652~     monotherapy dosed orally once daily (QD) for 10 days in HIV 1-infected, antiretroviral~     treatment-experienced, CCR5 antagonist-naïve patients.~   "
188888|NCT01092091|"~     The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is~     safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).~   "
188889|NCT01092078|"~     Black men constitute the demographic group with the greatest burden of premature death and~     disability from hypertension (HTN) in the United States. But while the disproportionately~     high rate of hypertension-related morbidity and mortality is well documented, the epidemic of~     colorectal cancer (CRC) among black men is comparatively under-appreciated. For example, CRC~     is a leading cause of cancer death in black men with a death rate 50% higher than in white~     men. Low rates of screening for CRC in this population contribute significantly to this~     problem. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of a~     lifestyle intervention delivered through telephone-based motivational interviewing (MINT)~     versus a patient navigation intervention on blood pressure reduction and CRC screening.~   "
188890|NCT01092065|"~     This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and~     effective and whether it can increase the therapeutic window of L-dopa in patients whose~     control of their Parkinson's Disease symptoms is limited by the development of dyskinesia~     induced by use of L-dopa.~   "
188891|NCT01092052|"~     The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase~     inhibitor, in adult patients with advanced/metastatic solid tumors.~   "
188892|NCT01092039|"~     The purpose of the study will be to assess the efficacy and safety of XIGO administered~     orally, three times a day, compared with placebo in patients with the common cold.~   "
188893|NCT01092026|"~     A pilot study to assess the feasibility of unrelated umbilical cord blood transplantation~     with coinfusion of third-party mesenchymal stem cells after myeloablative or nonmyeloablative~     conditioning in patients with hematological malignancies.~      This is a multicenter single arm, phase I-II pilot study. The primary objective of this study~     is to determine the feasibility of UCB HSCT with co-infusion of third party mesenchymal stem~     cells as assessed by the treatment-related mortality at d100 after transplant.~      Patient inclusion criteria:~      Age 15-60 yrs Patients for whom allogeneic stem cell transplantation is the preferred~     treatment option, with the following hematological malignancies:acute myeloid leukemia, acute~     lymphoblastic leukemia, high risk myelodysplastic syndrome, advanced lymphoproliferative~     disorders, chronic myeloid leukemia (refractory or intolerant to second-line tyrosine kinase~     inhibitors), multiple myeloma Informed consent given Patient exclusion criteria Previous~     allogeneic transplant Progressive malignant disease Significant organ damage as a~     contraindication to allotransplantation Significant psychiatric or neurological disorder~     Uncontrolled viral, fungal or bacterial infection Pregnancy HIV positive Patients will~     receive either myeloablative or reduced intensity conditioning. One or 2 cord blood~     transplants will be transplanted, followed by infusion of a third-party mesenchymal stem cell~     transplant Adverse event reporting BHS transplant committee will establish a protocol review~     committee which will organize a central monitoring of the study. Within the context of~     allogeneic HSCTx many severe events are likely to occur.~      Statistics and stopping rules The trial will be stopped at any time that there is reasonable~     evidence that the true rate of day +100 nonrelapse mortality exceeds 0.40. It is the~     intention to include an initial 20 patients.~   "
188894|NCT01092013|"~     This prospective randomized study aims for determination whether focused simulator based~     laparoscopic camera training in novices can improve camera performance in an actual clinical~     situations in the same manner as traditional training in the OR does, especially considering~     efficient use of training time.~   "
188895|NCT01092000|"~     The purpose of the challenge is to see if we, as the nutrition experts, can follow the~     dietary and physical activity guidelines promoted to the public. We have an opportunity to~     practice what we preach. Scientific evidence demonstrates, knowledge is not enough to~     change ones'behaviors. It is through positive approaches and lifestyle changes that behavior~     can be altered. By experiencing the planning, work, and motivation required to make lifestyle~     changes we can all be better clinicians.~   "
188896|NCT01091987|"~     The study wants to examine the feasibility of a non-pharmacological approach for insomnia in~     nursing homes provided by trained nurses/paramedics and physicians.~   "
188897|NCT01091974|"~     This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of~     cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female~     breast cancer patients who report sleep disturbances following completion of chemotherapy.~   "
188898|NCT01091961|"~     Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective~     surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning~     of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30~     days after surgery to assess any adverse health outcomes.~   "
188899|NCT01091948|"~     Following informed consent, patients will be randomly assigned to oral fiberoptic intubation~     or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of~     general anesthesia a sealed envelope would be opened to reveal the technique to be used. A~     stop watch will be started at the beginning of the procedure. At the completion of intubation~     the stop watch will be stopped and the time recorded along with other data. Based on a sample~     size estimation process, it is the investigators plan to study fifty patients. The two~     techniques will be compared in terms of the average time needed to place the endotracheal~     tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure~     comparability between the two methods, all intubators will be required to have at experienced~     at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.~   "
188900|NCT01091935|"~     The purpose of this study is to prospectively determine the side effects profile in adults~     with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body~     weight, infused over 45 minutes.~   "
188901|NCT01091922|"~     The primary propose of this study is to determine the impact of flavanol-rich cocoa on the~     growth of the human gut microbiota.~   "
188902|NCT01091909|"~     The purpose of this study is to evaluate clinical healing after dental extraction and the~     occurrence of surgical complications in patients with type 2 diabetes and compare with~     non-diabetic patients or control, taking into account laboratory data such as blood count,~     glycated hemoglobin (HbA1) and immunological profile of the patients.~   "
188903|NCT01091896|"~     The purpose of this study is to determine the effect of pre and intra-operative bevacizumab~     injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to~     vitrectomy without bevacizumab injection.~   "
188904|NCT01091883|"~     The goal of this study is to collect comparative data on safety and efficacy of MR Guided~     Focused Ultrasound and External Beam Radiation for treatment of metastatic bone tumors or~     multiple myeloma.~   "
188905|NCT01091870|"~     A Randomized Clinical Trial with security and dose testing of Sildenafil Citrate in patients~     with subarachnoid hemorrhage due to a rupture of a cerebral aneurism for prevention of~     cerebral vasospasm. The cerebral vasospasm is a decrease in blood flow that occurs when the~     intracranial vessels lose their capability of self-control of dilations and contractions.~     Patients with subarachnoid hemorrhage without neurological deficits who underwent~     endovascular or surgical correction of the aneurysm can participate in this trial. They will~     be randomized to a daily doses of 75 mg of Sildenafil, 150 mg of Sildenafil or Placebo from~     the third to the 14th day post bleeding. Today there is no proven clinical treatment for~     prevention of cerebral vasospasm.~   "
188906|NCT01091857|"~     Rates of cancer and cardiovascular disease have shown very little improvement over the past~     two decades, and the incidence of Type II diabetes mellitus is increasing at an alarming~     rate. Recent reports estimate that approximately 30% of total cancer deaths are related to~     poor exercise and nutrition, and other reports have suggested that, when taking into~     consideration both cardiovascular disease and cancer, inactivity contributes to as many as~     250,000 premature deaths per year (Booth et al., 2002). Despite the benefit of regular~     physical activity in the prevention of cancer and other debilitating illnesses, 75% of the~     U.S. population do not get the recommended amount of physical activity as defined by 30~     minutes of moderate intensity physical activity 5 or more days per week (CDC, 2001), and 40%~     of the population is completely sedentary (USDHHS, 19960. The objective of the proposed~     research is to understand the mediators and moderators of a well-tested individually~     tailored, print-based intervention to increase exercise behavior among sedentary adults.~     Using a randomized, controlled intervention ton trial, the proposed study will address three~     primary and one secondary hypotheses: 1) A previously tested and validated exercise promotion~     intervention (c.f., Marcus et al., 1998) is successful at helping sedentary individuals~     initiate and maintain a moderate intensity physical activity regimen, as compared to a health~     and wellness control intervention, 2) Increases in positive attitudes, perceived normative~     support, self-efficacy, and intentions to exercise will mediate the effectiveness of the~     intervention, 3) That increased positive mood, and better temperature, stress, and lactate~     regulation immediately after exercise challenge (assessed in the laboratory) will moderate~     the effectiveness of the intervention, and 4) Secondarily, we will test whether gender,~     race/ethnicity, and two recently suggested genetic factors (BDNF and OPRM1) moderate the~     effectiveness of the intervention. The rigorous assessment of how and for whom an exercise~     promotion intervention is effective will provide information for future development of~     intervention strategies and content, as well as allow the targeting of exercise content to~     individuals for whom it is most likely to be effective.~   "
188907|NCT01091844|"~     Purpose: The purpose of this study is to determine if two different methods of performing a~     postoperative voiding trial are equivalent in evaluating urinary retention after gynecologic~     surgery.~      Participants: The participants in this study will be women who have undergone gynecologic~     surgery at UNC-Chapel Hill.~   "
188908|NCT01091831|"~     This is a multicenter, randomized, open label study designed to compare the efficacy and~     safety of lenalidomide with low-dose alkylating agents versus high-dose melphalan followed by~     stem cell support in newly diagnosed symptomatic MM patients who are 65 years of age or~     younger.~   "
188909|NCT01091818|"~     Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind~     study of intensive care children, age 2-17 years.~      The investigators' primary hypothesis is that time from end of medication to extubation will~     be shorter with dexmedetomidine sedation.~   "
188943|NCT01091376|"~     Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable,~     non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still~     controversial.The objective of this study was to evaluate the efficacy and toxicity of a~     concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation~     treatment.~   "
188910|NCT01091805|"~     The purpose of this research study is to see if GE reflux events are associated with~     increasing levels of pepsin in spit samples. Pepsin is a special protein called an enzyme~     that is made only in your stomach. It is not normally found in your throat. Pepsin breaks~     down food proteins that you eat to form nutritional building blocks that your body can use to~     grow. An enzyme is a substance that helps break down proteins.~      Gastroesophageal reflux disease (GERD) is very common in infants and children, but can result~     in serious health problems if not accurately diagnosed. The investigators currently do not~     have a definitive test to be used as a standard for diagnosing pediatric GERD.~      Measurement of pepsin, an enzyme normally produced only in the stomach, has been used as a~     non-invasive way to detect gastric aspiration (reflux of stomach fluid into the airway) in~     both adults and children, but using pepsin to detect reflux has not been tested. Since pepsin~     should not be present in the normal esophagus and respiratory tract, but is always present in~     reflux fluid from the stomach, the investigators believe that the more GE reflux the~     investigators detect, the higher the levels of pepsin the investigators see in the fluid~     collected from the mouth. If patients do not have GE reflux, but have swallowing problems~     alone in which food or liquid goes into the airway, the investigators expect that these~     patients will have no pepsin in the fluid collected from their mouth.~      The investigators will test these hypotheses by measuring pepsin levels from mouth fluid and~     comparing them with the number of GE reflux events the investigators find using the~     pH/impedance (MII (multichannel intraluminal impedance)) test. Since the investigators are~     interested in pepsin levels for all types of reflux - acid and non-acid -the investigators~     will study children whether or not they are on acid blocking medicines. The investigators~     will also look at pepsin levels in patients whose pH/MII is normal, but have aspiration alone~     that the investigators find on a modified barium swallow (MBS) study. The investigators will~     measure pepsin levels in healthy children with no reflux symptoms and no swallowing problems~     as the investigators controls. The investigators anticipate that this study will show a~     positive correlation between GE reflux events and the presence of oropharyngeal pepsin, which~     may allow us to use pepsin as a way to test for reflux.~   "
188911|NCT01091792|"~     Blood samples will be obtained from newly diagnosed GBM patients treated with combined~     radiotherapy (RT), temozolomide (TMZ) and bevacizumab (BEV) at specific time points. The~     primary outcome is the shift in T reg cell fraction a defined by determining the proportion~     of CD4 cells that are CD4+ CD25.~   "
188912|NCT01091779|"~     Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal~     Anesthesia for TURP Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive~     Patients.~   "
188913|NCT01091766|"~     The purpose of this prospective randomised study is to investigate electrocardiographic~     alterations after intravascular injection of three different test solutions of bupivacaine~     and epinephrine in anaesthetised children up to 16 years of age.~   "
188914|NCT01091753|"~     The purpose of this study is to determine the effect of nocturnal administration of~     Anti-hypertensive medications in Non-dippers.~      Efficacy variables.~        1. ECHO~        2. 24hr. horter~        3. IMT~        4. BUN/crea, urine analysis (microalbulinuria~        5. Cardio vascular event. ~   "
188915|NCT01091740|"~     This study try to 1) evaluate the neointimal coverage and malapposition at 3 month after new~     zotarolimus eluting stent (Endeavor resolute) and everolimus eluting stent (Xience)~     implantation and 2) compare them between ZES resolute and EES at 3 months (early period)~     after stent implantation.~   "
188916|NCT01091727|"~     This is a prospective, multicentre (7 sites), randomized, double-blind, study comparing~     intravesical injection of BOTOX to placebo in 56 subjects with NDO secondary to spinal cord~     injury or multiple sclerosis. Study subjects will be randomized to one of the following two~     treatment groups:~      Group 1 n=28 BOTOX - 300U Group 2 n=28 Placebo BOTOX (saline)~      All study subjects will receive one injection cycle (BOTOX 300U or Placebo) at Visit 2~     (Treatment, Day 0) as per Supplement III. The study duration is approximately 61 weeks and~     consists of a Pre-Treatment Evaluation, a Treatment/Randomization Visit (Visit 2, Day 0),~     Telephone Follow-ups at 1, 3 and 4 weeks post-treatment, and Follow-up Visits at 6, 24 and 36~     weeks (Visits 3 to 5). At Week 36, subjects will be offered open-label BOTOX 300U and will be~     followed for an additional 6 months, returning for evaluations at Weeks 48 and 60.~   "
188917|NCT01091714|"~     To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective~     levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending~     on a specific product utilized within this study.~   "
188918|NCT01091701|"~     This study will evaluate the safety and efficacy of intravenous ex vivo cultured adult~     allogenic mesenchymal stem cells in patients with ischemic cerebral stroke. Patient will be~     given single intravenous dose of allogenic mesenchymal stem cells 2 million cells/Kg body~     weight or placebo within 10 days of stroke. Patients will be followed up till 12 months.~     Safety will be evaluated by type, number and proportion of patients with adverse events.~     Efficacy will be evaluated by clinical parameters and MRI.~   "
188919|NCT01091688|"~     We, the investigators, will provide Just-in-Time information, physician educational~     material, to primary care pediatricians of Neonatal Intensive Care Unit (NICU) graduates at~     the time of NICU discharge. We will follow the rate of adverse events (deaths,~     re-hospitalizations, emergency room visits, and missed appointments) for 6 months after NICU~     discharge. We will assess levels of physician comfort in caring for NICU specific diseases,~     as well as physician satisfaction with the discharge process. We hypothesize that the~     provision of Just-in-Time information will decrease the rate of adverse events, and make~     physicians more comfortable in caring for complicated NICU graduates, and more satisfied with~     the discharge process.~   "
188920|NCT01091675|"~     The goal of this research is to assess the percentage of non-responders to ≥ 2 NSAIDs~     candidates a biological therapy that could adequately respond to treatment with etoricoxib~     This study confirm the result of a previous study in a wider similar population. Basing on~     previous results, the response rate will be assessed by ASASBIO criteria. The efficacy of the~     treatment with etoricoxib 90 mg will be assessed at week 4 in a population of patients with~     AS who didn't respond adequately to a previous therapy with ≥ 2 NSAIDs.~      Those patients that, based on the ASABIO criteria, achieved a sufficient clinical response~     will be followed until week 24 to asses the maintenance of the study drug effects.~   "
188921|NCT01091662|"~     This is an 18-week, double-blind, multicenter study with gradual conversion from previous~     antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial~     epilepsy.~   "
188922|NCT01091649|"~     The objective of this study is to assess the relative bioavailability of two test tablet~     formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a~     reference.~   "
188929|NCT01091558|"~     The purpose of this study is to look at the importance of L-Arginine in the digestive tract.~     L-Arginine is an amino acid and is important in making proteins within the cell.~      The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us~     learn more about L-Arginine and ulcerative colitis. The investigators believe these studies~     will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative~     colitis) and nutritional needs. The investigators plan to enroll 200 participants in this~     study over the next two years.~   "
188923|NCT01091636|"~     The current standard treatment for ovarian cancer, tubal cancer, and primary peritoneal~     cancer is maximal cytoreductive surgery followed by chemotherapy. Recent randomized trials of~     Gynecologic Oncology Group (GOG) revealed the survival gain in intraperitoneal chemotherapy~     compared to the intravenous chemotherapy after the optimal cytoreduction in ovarian cancer~     (GOG#104, GOG#114, GOG#172). Experts attributed such survival gain to the earlier cycles of~     intraperitoneal chemotherapy when adhesion was minimal from extensive cytoreductive~     procedures.~      Hyperthermia has an anti-cancer activity itself. Especially, hyperthermia promotes~     chemotherapy to penetrate deeper into the cancer tissue. Therefore, the combination of~     intraperitoneal chemotherapy with hyperthermia theoretically could lead to higher response~     rate and better survival outcomes.~      *HIPEC: hyperthermic intraperitoneal chemotherapy~      There will be an interim analysis when 50% of patients are enrolled.~      At the interim analysis, a statistical test will be performed. The nominal significance~     levels will be determined later. The exact nominal significance level will be determined~     based on the exact number of events at the time of the interim analysis. The Stopping~     boundaries will be calculated using an O'Brien-Fleming error spending function~   "
188924|NCT01091623|"~     Background. Exercise intolerance is one of the most devastating consequences of chronic~     obstructive pulmonary disease (COPD). Abnormalities in peripheral muscle function such as~     weakness and reduction in oxidative enzyme activities are commonly found in these patients~     and may contribute to exercise intolerance.To evaluate whether a systemic weightlifting~     exercise may improve exercise capacity better than endurance training, or a combined training~     is more effective, the investigators compared three different training regimens, endurance~     training alone, systemic weightlifting training alone or a combination of both endurance and~     weightlifting training.~      Methods.36 patients with stable COPD will be evaluated before and after a 4 month training~     program. Each evaluation include a stepwise exercise test on an ergocycle up to the~     individual maximal capacity during which minute ventilation (VE), oxygen consumption (VO2),~     carbon dioxide production (VCO2), and arterial lactic acid concentration will be measured and~     the peripheral muscle strength will be determined with the one repetition maximum for eight~     different muscle groups. Percutaneous needle muscle biopsy from the M.vastus lateralis will~     be performed before and after the training period in order to determine the fiber-type~     proportions. Patients are assigned to one of the following three groups (1) endurance~     training consisted of 20 min exercise sessions on a calibrated ergocycle two times a week,~     with a target training intensity at 60% of individual maximum oxygen uptake, (2) systemic~     weightlifting training two times a week with eight different exercises, each session consist~     of 15 repetitions of each muscle group, (3) combination of endurance training and systemic~     weightlifting training.~      Statistical analysis. Baseline data for all patients enrolled in the study will be compared~     by one-way analysis of variance for the three study groups. Results before and after training~     will be analyzed by two- way analysis of variance.~   "
188925|NCT01091610|"~     Ambulance personnel often work in a dangerous environment and work related injuries of~     emergency medical staff have repeatedly been documented. However, only case reports are~     published and no data exist about the incidence and type of work related injuries of~     ambulance personnel.~      Aims:~      The primary aim of the study is to assess the incidence (number of new injuries per 100'000~     emergency missions or per 1'000 flying hours) and type of work related injuries among~     prehospital emergency personal. The secondary aims are to identify risk factors associated~     with work related injuries and to compare the risk of injury to other groups of professionals~     such as hospital nurses, policemen or fire-fighters.~   "
188926|NCT01091597|"~     Curative catheter ablation has been established as an effective therapeutic option for atrial~     fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However,~     standard ablative approaches targeting the pulmonary veins (PVs) are associated with a~     success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of~     catheter ablation of AF isolating the posterior left atrium including all PVs (called Box~     Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6~     months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs,~     with a single procedure success rate of 87% (40/46). This study provided new evidence~     supporting the hypothesis that the posterior wall is of high importance for the maintenance~     of AF. The aim of the investigators study is to determine the efficacy of two different~     approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment~     of chronic AF.~   "
188927|NCT01091584|"~     The use of interventions for cancer-related distress is important to reduce this distress.~     Distress has a negative impact on quality of life, the recovery during and after treatment~     and may even adversely affect survival. There is insufficient attention to the systematic~     approach to psychosocial problems in cancer patients in the Netherlands. A task force~     discussed and studied which instrument measures psychosocial problems best. The distress~     thermometer (lastmeter) had the best results. A guideline is written to use the distress~     thermometer for patients with cancer and will be used in hospitals in the Netherlands.~     However, it is not clear what the effects are of the use of the distress thermometer on the~     psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the~     distress thermometer leads to cost-effective care. The study focuses on the use of the~     distress thermometer in breast cancer patients. An efficiency study (RCT) will be conducted~     to evaluate the systematic use of the distress thermometer and its discussion by a nurse as~     compared to the usual care provided to outpatients who are treated with curative intent for~     breast cancer by their treating physicians. The clinical and economic impact of the use of~     the Distress thermometer will be assessed in comparison with usual care.The recruitment of~     patients will take place in the out-patient clinic of a university hospital. Patients will be~     followed from diagnose until two years after finishing their treatment.~   "
188928|NCT01091571|"~     During sepsis and septic shock the immune response can be overwhelming leading to excessive~     tissue damage, organ failure and death. Ideally, the inflammatory response is modulated~     leading to both adequate protection to invading pathogens as well as limitation of an~     exuberant immune response. In the last few years adenosine is proposed to have a central role~     in the modulation of inflammation. In unfavorable conditions such as hypoxia, ischemia or~     inflammation adenosine is quickly up-regulated; with concentrations up to tenfold in septic~     patients. Many animal studies have shown that adenosine is able to attenuate the inflammatory~     response and decrease mortality rates. Therefore, pharmacological elevation of the adenosine~     concentration is an potential target to attenuate inflammation and limit organ injury.~     Dipyridamole, an adenosine re-uptake inhibitor is able to increase the adenosine~     concentration and limit ischemia-reperfusion injury. In order to study the effects of~     dipyridamole on the inflammatory response we aim to use the so called human endotoxemia~     model. This model permits elucidation of key players in the immune response to a gram~     negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel~     therapeutic strategies in a standardized setting.~   "
188930|NCT01091545|"~     To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM)~     regarding effectiveness as screening modalities.~   "
188933|NCT01091506|"~     This study is a 12-week, double-blind, placebo-controlled trial of L-methylfolate 15 mg/d~     supplementation in schizophrenia patients with mild or greater negative symptoms.~     L-methylfolate, a prescription medical food, is the activated form of folate required for~     conversion of homocysteine to methionine and hence is the optimal form of folate for~     supplementation, since it eliminates the need for activation by MTHFR. The purpose of this~     study is to examine the change in plasma L-methylfolate concentrations following a~     three-month trial of L-methylfolate 15 mg/d compared to placebo.~   "
188934|NCT01091493|"~     COPD is one of the most important causes of morbidity and mortality and supposes a sanitary~     problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation~     of COPD (AECOPD) per year, being these the principal causes of of hospitalizations,~     respiratory problems and medical visits. After an episode of AECOPD, the majority of patients~     develop a transitory (or permanent) worsening in their quality of life and 50% of them will~     require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with~     a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an~     evidence of viral infection could be documented. Even though the antibiotic treatment might~     not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in~     some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD~     results in a very expensive disease and raises the rate of resistance of bacteria. The~     available literature have shown that there's a relation between exacerbations and infections,~     based on sputum samples.~      In summary, is well known that at least a 50% of the episodes of AECOPD might be associated~     with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide~     and generalized in hospitalized patients. Clinical trials have shown correlation between~     AECOPD with sputum purulence (which correlates with presence of bacteria), however they've~     not included NON-purulent AECOPD, even though they're a significative group of patients~     hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of~     antibiotic treatment in this group of patients in a well designed trial.~   "
188935|NCT01091480|"~     Hypertrophic cardiomyopathy (Hypertrophic CardioMyopathy=HCM) remains a poorly understood~     disease with an assumption insufficiently codified. There is no data available in France on~     the profile of patients, diagnostic methods and assessment and therapeutic use.~      The purpose of this study is to establish a monitoring of patients with HCM (sarcomere of~     origin or not) in France (diagnosis, treatment)~   "
188936|NCT01091467|"~     The purpose of this study is to examine electrical and echocardiographic characteristics and~     prognosis of consecutive patients admitted with acute heart failure and diagnosed to have~     heart failure with preserved ejection fraction (HFPEF).~   "
188937|NCT01091454|"~     This phase II trial studies how well brostallicin and cisplatin work in treating patients~     with breast cancer that has spread to other parts of the body (metastatic) and does not have~     estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor~     receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as~     brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from spreading.~   "
188938|NCT01091441|"~     The observatory consists of a row of data collection on a population composed of all patients~     with heart failure cared for in centers participating in the national education program for~     patients (named I-CARE) in the form of two groups. Patients who are undergoing a program of~     therapeutic education track are listed and included in the group of patients educated.~     Patients who receive no education or only a minimal element for any reason whatsoever are~     also listed and included in the group of patients who are not educated.~      The following of patients will be periodic after their entry in the observatory, up to 2~     years of follow up.~   "
188939|NCT01091428|"~     This is an open-label, multicenter study with a nonrandomized Phase 1 portion and an~     open-label, randomized, Phase 2 portion evaluating MLN8237 in combination with weekly~     paclitaxel in adult female patients with advanced breast cancer (Phase 1 portion only) and~     recurrent ovarian cancer (both Phase 1 and Phase 2 portions).~   "
188940|NCT01091415|"~     The incidence of distal radius fracture (DRF) increases with age, and thus, because of~     improving life expectancies, these fractures are set to become more common. Fractures of the~     distal radial metaphysis are known to be strongly related to osteoporosis, and as a result,~     the management of distal radius fractures in elderly patients is beset with difficulties.~      Recently, more aggressive fracture fixation in the elderly has become a topic of interest, in~     the hope of increasing the rate of recovery to preserve the ability to live independently.~     Many elderly patients remain active well into their eighth and ninth decades, for example,~     some pursue activities, such as, golf and tennis, on a daily basis. The introduction of volar~     locking plating system has increased this interest. This system, which uses a fixed angle~     principle, has been proposed to be effective at maintaining good anatomic reduction, even in~     the elderly. However, there is a still concern about remaining metaphyseal defect after~     reduction of the osteoporotic DRF.~      Injectable calcium phosphate bone cement (CPC) has been used to augment the remaining~     metaphyseal defect after fracture reduction including DRF, specially in osteoporotic old~     patients. The purpose of this randomized, prospective study was to investigate that~     additional CPC augmentation has any benefit over volar locking plate fixation in unstable DRF~     patient who is older than 65. The null hypothesis is that there is no difference of wrist~     functional outcomes, radiographic outcomes, and complications between treatment of volar~     locking plate alone and calcium phosphate bone cement as well as volar locking plate in~     unstable DRF patient who is older than 65.~   "
188941|NCT01091402|"~     One of the proposed mechanisms in CU is autoimmunity. It was shown by a positive response to~     autologous serum skin test (ASST)in almost half of chronic urticaria (CU) patients. IL-18~     also play a role in autoimmune disorders. The investigators aim was to investigate the~     relationship of ASST and IL-18 in CU and respiratory allergic diseases.~   "
188942|NCT01091389|"~     This study aims at investigating the role of autonomic modulation of AF. Therefore, totally~     thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be~     studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without~     structural heart disease and persistent AF with or without heart disease) of 110 patients~     each will be studied.~   "
188944|NCT01091363|"~     Nicotine dependence is very common among Asian Americans; yet, research on understanding and~     treating nicotine dependence in this group is almost nonexistent. The proposed study is a~     first attempt to develop a smoking cessation program that is tailored to Korean-culture~     specific aspects. It is proposed that Korean Americans who receive a culturally tailored~     smoking cessation program will be more likely to have prolonged abstinence at 12-month~     follow-up than their counterparts who receive brief cessation counseling. Subjects in both~     arms receive nicotine patches for 8 weeks. Self-reported abstinence is validated with exhaled~     carbon monoxide and salivary cotinine tests.~   "
188945|NCT01091350|"~     The aim of this study is to validate that an effect compartment concentration for loss of~     consciousness (LOC) was varied according to different Keo value.~   "
188946|NCT01091337|"~     To compare the efficacy and safety of inhaled procaterol (Meptin Air) versus inhaled~     salbutamol as metered dose inhaler (MDI) reliever of acute exacerbation of asthma not in~     imminent respiratory failure.~   "
188947|NCT01091324|"~     The investigators test the renal and cardiovascular protective effects dextromethorphan and~     silymarin on patients with the proteinuric chronic kidney diseases, who enrolled in our~     clinical trial, had progressing kidney diseases and merit aggressive anti-inflammatory~     therapy.~   "
188948|NCT01091311|"~     Multicentric study, open label, uncontrolled phase IV in 30 patients with meibomian glands~     dysfunction .~      Its objective is to Collect information from patients and ophthalmologists specialized in~     ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.~      This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.~      Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two~     uses per day) and complete a questionnaire every two days during the first week and then once~     a week the next two weeks.~   "
188949|NCT01091298|"~     This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus~     vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at~     the highest possible viral concentration in 0.5 mL of vaccine.~   "
188950|NCT01091285|"~     A randomized controlled double blinded study to investigate whether a specially designed~     double balloon catheter is more efficient than a foley catheter for cervical ripening and~     induction of birth.~      160 women with singleton term pregnancies with un ripe cervix and no contraindications for~     catheters will be included and randomized to either double og single balloon catheters for~     cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the~     amount of women where the cervix has become ripe enough for amniotomy.~      Our hypothesis is that double balloon catheters will give a greater amount of women where~     amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till~     birth, vaginal deliveries and complications during or after birth for the mother or child~     will also become recorded.~   "
188951|NCT01091272|"~     The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after~     administration of a single dose to healthy volunteers, and to evaluate the plasma drug~     concentrations after single dose in healthy volunteers.~   "
188952|NCT01091259|"~     The purpose of the study is to evaluate the efficacy and toxicity of irinotecan in the~     treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when~     combined with bevacizumab.~   "
188953|NCT01091246|"~     The primary objective of this study is to demonstrate the immunologic noninferiority of~     Q/LAIV to FluMist in children 2 to 17 years of age.~   "
188954|NCT01091233|"~     Patients with liver cirrhosis are at risk for development of renal failure, usually after a~     precipitating event such as infection or bleeding. This form of renal failure has a high~     morbidity and mortality and may be partly caused by increased intra-abdominal pressure~     secondary to ascites. Recent studies have shown that paracentesis (and the resulting~     decreased IAP) can increase urinary output and decrease renal arterial resistive index in~     patients with hepatorenal syndrome (a very pronounced form of renal failure in cirrhosis~     patients). The aim of this study is to evaluate the influence of Paracentesis on~     intra-abdominal pressure and kidney function in critically ill patients with liver cirrhosis~     and ascites across a wider range of kidney function. Kidney function will be evaluated using~     several estimates of glomerular filtration rate and measures of kidney injury i.e. cystatin~     C, serum NGAL, creatinine clearance, urinary output and renal arterial resistive index.~   "
188955|NCT01091220|"~     The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on~     the quality of sperm obtained from healthy male volunteers.~   "
188956|NCT01091207|"~     With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor~     imatinib, there has been substantial improvement in overall survival in patients with~     advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed~     activity as second-line therapy in GIST patients after failure with imatinib. However,~     virtually all patients will eventually progress or become intolerable after imatinib and~     sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of~     imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study~     is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.~   "
188957|NCT01091194|"~     This is a randomized controlled trial which will include approximately 50 heart transplant~     recipients 1-8 years after heart transplantation. The intervention and follow up period is 1~     year. The primary purpose is to investigate if systematic, high intensity, interval-based~     aerobic exercise training results in a greater improvement of exercise capacity (measured by~     VO2peak) than previously shown in heart transplant recipients.~   "
188958|NCT01091181|"~     The Effect of Cesarean Operative Technique on the Occurrence of Large Hysterotomy Scar~     Defects.~   "
188959|NCT01091168|"~     In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes,~     antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs,~     therapeutic options are very limited. Alkylating agents showed a modest activity in~     pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and~     the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients~     who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.~   "
188960|NCT01091155|"~     The performance of the ColonRing™ will be comparable to or better than the reported~     performance of staplers.~   "
188965|NCT01091090|"~     Millions of individuals with chronic pain smoke and our preliminary research suggests that~     currently available strategies to help people quit smoking may not be effective for~     individuals with chronic pain. This is important in that smokers with chronic pain have worse~     pain-related health outcomes compared to nonsmokers with chronic pain. The primary aim of~     this research project is to develop a smoking cessation intervention for specific use in an~     outpatient clinical setting for smokers with chronic pain.~   "
188966|NCT01091077|"~     Hepatitis C virus when it leaves the cells in the liver is bound to a type of fat. An~     component of grapefruit could block this fat and thus lower the amount of virus in the blood~     stream. We propose that treatment with this ingredient, called naringenin, could be used to~     block this fat and HCV in persons infected with hepatitis C.~   "
188967|NCT01091064|"~     Acute viral bronchiolitis is the principal cause of lower respiratory tract infection in~     infants worldwide. It is characterized by a first episode of respiratory distress preceded by~     rhinorrhea, cough and fever. The majority of patients present with mild symptoms which can be~     treated safely at home by parents. Every year between October thru April emergency~     departments in North America are overwhelmed with patients waiting to be seen with mild~     respiratory infections, such as bronchiolitis. Thus new strategies in health care have to be~     elaborated to reduce costs and waiting time in the emergency department.~      The investigators hypothesize that patients liberated from triage with mild acute viral~     bronchiolitis would have the same rate of office re-visits than those with mild acute~     bronchiolitis in the emergency department.~   "
188968|NCT01091051|"~     This study will provide data on sasety and efficacy of Ustekinumab in patients suffering from~     Palmo-Plantar Pustular Psoriasis (PPPP) or Palmo-Plantar Pustulosis(PPP)~   "
188969|NCT01091038|"~     The study will measure the effect of basic clinical decision support on medical errors and~     adverse drug events in the ambulatory setting.~   "
188970|NCT01091025|"~     The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients'~     survival improves. Early diagnosis of CFRD is crucial to prevent the unnecessary~     deterioration of lung function and nutritional status, both of which affect the patient's~     overall survival. The oral glucose tolerance test (OGGT) is the accepted method for detecting~     CFRD. The Cystic Fibrosis Trust guidelines (2004) recommend that patients with CF over the~     age of twelve years should be screened annually. Most hospitals use an annual OGTT.~     Performing OGTT on all CF patients is inconvenient and may not be cost effective, as patients~     have to starve overnight and need to spend an extra 2 hours in the hospital in addition to~     all the other annual review tests. In our centre, a selective approach is used. If patients~     have an abnormal random blood glucose and /or abnormal glycosylated haemoglobin (HbA1c)~     and/or symptoms of hyperglycaemia or unexplained weight loss then an OGTT will be performed.~      The aims of this study are~        1. To compare the clinical efficiency in the screening for CFRD in the two different~          methods: i)a selective approach , ii)an unselected annual OGTT for all patients.~        2. To compare the cost effectiveness of the two approaches in the screening for CFRD.~   "
188971|NCT01091012|"~     The main objective is to validate the safety and efficacy of intravenous and oral sildenafil~     in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary~     hypertension after valvular surgery successfully, with a correct left ventricular function~     and no valvular disease hemodynamically significant.~   "
188972|NCT01090999|"~     OBJECTIVE: To determine whether a long-term maintenance program after respiratory~     rehabilitation, in contrast to the usual minimal maintenance therapy, improves the~     cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity,~     HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely~     through reduction of exacerbations.~      MATERIAL AND METHODS: multi-center (4 hospitals) prospective randomized controlled study that~     will include 150 patients with moderate-severe COPD (age <75; BODE 4-10) with a 3 years~     follow-up. All patients will receive an initial in-hospital rehabilitation program which~     includes: Education, Physiotherapy, lower and upper extremities training and respiratory~     muscles training. Following completion of this program, patients will undergo concealed~     randomization to one of two maintenance strategies:1.-an intensive maintenance program (GR1)~     2.- a standard, minimal monitoring program (GR2). On the intensive maintenance program (GR1)~     the physiotherapist will call once a week as a reminder and the patient will attend the~     hospital once a week . A physiotherapist will supervise the weekly in-hospital exercise and~     he/she will check if the patient is properly undergoing the rehabilitation treatment.~      OUTCOMES: 1.- Clinical: dyspnea (area of CRQ questionnaire), HRQL (CRQ, SF 36); Effort~     capacity (6minute Walking Test), BODE index; 2.- Economical: direct costs (programs);~     indirect costs (exacerbations, admissions); comparison of GR1 and GR2 costs; EXPECTED~     OUTCOMES: reduction of dyspnea, improvement of HRQL, effort capacity and BODE index, and~     reduction of health expenditures in GR1 compared to GR2.~   "
188973|NCT01090986|"~     Non invasive ventilation (NIV) usually presents air leaks that may determine the result of~     this treatment. The clinical usefulness of analyzing (and quantifying) these leaks during the~     adaptation period to NIV has not been evaluated in prospective clinical studies as a~     predictive data of treatment effectiveness. Our hypothesis is that air leaks are correlated~     to a successful adaptation to NIV. And air leak magnitude may predict early failures of this~     treatment. And also, as we do not know if air leaks change during the adaptation period to~     NIV, we do not know whether early detection of air leaks plays a role in the therapeutic~     outcome. Our objective is to evaluate the clinical usefulness of quantifying air leaks during~     the adaptation period to NIV as a predictor of effectiveness of this treatment. We also want~     to evaluate the correlation between air leaks and clinical-functional patients' profile, and~     the ventilatory parameters selected and to evaluate air leaks variability during the~     adaptation period to NIV. Method: We will determine the air leak magnitude in twenty patients~     during adaptation to NIV. We will use VPAP III ventilators (ResMed, Australia), commercial~     nasal masks (Mirage o Ultra Mirage) and VPAP III/ResLinkTM (ResMed, North Ryde, Australia), a~     device that includes a monitoring system coupled with the VPAP III ventilator. This device~     allows to record air leaks and other ventilation parameters. We will perform four VPAP~     III/ResLinkTM recordings in each patient (the last night in hospital during the adaptation~     period, the first night at home, and one and two months later, after the initiation of NIV~     treatment). We will also perform a complete pulmonary function test, quality-of-life~     questionnaire (SF36), and a tolerance to NIV questionnaire in all patients at the onset of~     NIV treatment and two months later. We will evaluate which patients will need to change~     treatment at the end of the adaptation period to NIV. We also will analyze and compare air~     leaks magnitude in each of the four recordings stated above.~   "
188974|NCT01090973|"~     The purpose of the study is to find out the effects and the safety of an investigational~     study drug called LBH589 when given to people with relapsed or refractory chronic lymphocytic~     leukemia (CLL) or mantle cell lymphoma (MCL).~   "
189148|NCT01088698|"~     Golimumab, a TNF-alpha antibody, has been approved in the EC and USA for the treatment of~     psoriatic arthritis. The aim of this study is to determine in a randomized half-side~     comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the~     clearance of psoriatic skin lesions in golimumab-treated patients.~   "
188975|NCT01090960|"~     This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and~     pharmacokinetics of escalating oral doses of GDC-0068 administered to patients with~     incurable, locally advanced or metastatic solid malignancy that has progressed or failed to~     respond to at least one prior regimen or for which there is no standard therapy. This study~     is expected to enroll approximately 39 to 57 patients at approximately two sites in Spain.~   "
188976|NCT01090947|"~     The purpose of the study is to optimize an already existing algorithm for diagnosing~     atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).~   "
188977|NCT01090934|"~     Multicenter prospective study comparing the diagnosis value of high-resolution EEG and~     depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.~   "
188978|NCT01090921|"~     This is a research study to see if a new drug called bortezomib is useful to treat multiple~     myeloma in people who are newly diagnosed, and have not yet received treatment for their~     disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium~     Pharmaceuticals, Inc.~   "
188979|NCT01090908|"~     This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety,~     and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI)~     in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection.~   "
188980|NCT01090895|"~     Primary Hypothesis: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous~     coronary intervention (PCI) would limit the size of the infarct, assessed by measurements of~     cardiac biomarkers, during acute myocardial infarction.~      Secondary Hypotheses: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous~     coronary intervention (PCI) would limit the size of the infarct, as measured by the area of~     delayed hyperenhancement that was seen on cardiac magnetic resonance imaging (MRI), assessed~     on day 5 after infarction, during acute myocardial infarction.~   "
188981|NCT01090882|"~     Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to~     same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall~     bladder decreases pain. In many patients pain has a strong component attributable to~     diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide~     high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise~     that LA injected to the right hemidiaphragm during LC would be more effective than wash.~      Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing~     elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline;~     Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control~     'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre~     recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to~     eating and mobilising, day case surgery.~   "
188982|NCT01090869|"~     The investigators aimed to evaluate the health benefits of physical training per se, weight~     loss per se and exercise-induced weight loss in young, overweight men. The investigators~     hypothesized that physical training would have independent effects on various health~     parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass,~     waist circumference, blood pressure and key muscle proteins), and that a concomitant weight~     loss from physical activity would increase the effect.~   "
188983|NCT01090856|"~     Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent~     implantation, the side branch became jailed and the carina can be displaced resulting in~     complete occlusion of this vessel. Re-wiring the side branch in this conditions may result~     difficult and some times impossible. There is no agreement regarding the need of side branch~     pre-dilation (before main vessel stent implantation) to reduce these complications.~     Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to~     avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the~     contrary, our group has a good experience in the treatment of bifurcation lesions treated~     with side branch pre-dilation.~      Aims: 1.- To determine the efficacy of the side-branch pre-dilation in patients with~     bifurcations lesions treated with provisional T stenting. 2.- To determine the success rate~     and incidence of complications in patients with and without side-branch pre-dilation, as well~     as economic impact in terms of number of used wires.~   "
188984|NCT01090843|"~     MiroCam® is the new video capsule endoscope of IntroMedic®. By using a novel transmission~     technology it promises a longer battery life expectancy with consequential impact on the~     length of the video recorded for diagnostic evaluation. As the investigators know about the~     shortcoming of battery life expectancy from many capsule examinations that were inconclusive~     because the ileocaecal transit was not filmed, the investigators would appreciate to have a~     capsule with extended video recording to improve the diagnostic yield of capsule~     examinations. Therefore the investigators want to compare MiroCam® to our routinely used~     Olympus® Enteropro EndoCapsule® in the context of a half-year clinical trial. Focussing on~     the total video length as well as on the rate of video-recorded ileocaecal transitions as~     surrogate parameters the investigators want to find out whether one of the two products~     provides superior diagnostic information in order to reduce the amount of inconclusive~     examinations.~   "
188985|NCT01090830|"~     The purpose of this study is to establish the safest dose of the investigational medication~     Belinostat that can be administered with a standard of care chemotherapy regimen of~     bevacizumab, carboplatin, and paclitaxel. Further study will examine the short and long-term~     effect (up to 2 years) of this medication on participant's disease status and overall~     survival.~   "
188986|NCT01090817|"~     Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form~     of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such~     therapy and require surgery. The hypothesis is that mesenchymal stromal cell therapy using~     third party human cultured cells will be safe and effective~   "
188987|NCT01090804|"~     The purpose of this study is to determined effects of BreatheMAX on secretion clearance.~   "
189020|NCT01090375|"~     In the present study the microdialysis method is used to investigate biochemical changes~     within and around the joint simultaneously in both the resting state and in a joint that had~     been subjected to exercise. The aim of the present study was, by applying the microdialysis~     technique, to monitor markers of cartilage breakdown and inflammation in 2 different~     positions of the knee (inside and in the inner part of the knee capsule) in a group of human~     females with knee osteoarthritis over a period of 3 hours.~   "
188988|NCT01090791|"~     Acute circulatory failure may be related to hypovolemia. Fluid loading increases stroke~     volume in approximatively half of challenges. Determining fluid responsiveness prevents~     unnecessary fluid loading. Passive leg raising (PLR) provides a transient increase of 300 ml~     in venous return for a short time. The measurement of stroke volume (SV) before and after a~     PLR test allows physician to detect fluid responsiveness, when stroke volume increases is~     higher than 15 %. Beside thermodilution, the use of non invasive device to measure stroke~     volume becomes largely employed. Arterial Pressure based Cardiac Output (APCO), provided by~     the Flotrac/Vigileo system, does not required specific materials nor repeated calibration.~     The third generation software is believed to be more accurate and more precise for SV~     measurement. The aim of this study is to test the performance of the Flotrac/Vigileo device~     in a situation of rapid venous return changes induced by PLR and then by fluid loading.~     Patients will be classify posteriorly in responders and non responders, according to the~     magnitude of the fluid loading-induced SV changes measured by transthoracic echocardiography.~   "
188989|NCT01090778|"~     This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and~     pharmacodynamic profiles of growth hormone using two different modes of growth hormone~     administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the~     thigh) in 8 adult male or female patients with growth hormone deficiency during interval~     exercise or in supine rest. The order of dosing regimen within the groups and between the~     groups will be randomised. All patients will go through four different treatment sessions:A/B~     Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions~     C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise.~     Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of~     growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian~     variation in pharmacokinetics of exogenous growth hormone infused subcutaneously~   "
188990|NCT01090765|"~     Background:~        -  Currently, there is no curative therapy for metastatic castrate-resistant prostate~          cancer (CRPC), a leading cause of death in men. However, researchers are exploring new~          treatments that involve drugs that prevent angiogenesis (the process by which new blood~          vessels are formed) and can slow or prevent tumor growth.~        -  TRC105 is an experimental drug that blocks angiogenesis, and has been studied for~          possible use in treating different kinds of cancer. However, it has not been validated~          to treat prostate cancer in general or CRPC in particular.~      Objectives:~        -  To determine the effects of TRC105 as a treatment for CRPC~        -  To determine the safety and effectiveness of TRC105 in treating CRPC~      Eligibility:~      - Men at least 18 years of age who have been diagnosed with castrate-resistant prostate~     cancer for which existing treatments have not been effective.~      Design:~        -  Eligible individuals will have a series of blood and other tests to determine their~          suitability for participating in the study.~        -  Participants will receive intravenous infusions of TRC105 in a 28-day treatment cycle.~          Participants will receive i.v. (intravenous) infusions of TRC105 every two weeks on days~          1 and 15 of each 28-day cycle (cohorts 1, 2, 3, 5, and 6) and every week on days 1, 8,~          15, and 22 of each 28 day cycle (cohort 4).~        -  Participants will receive different doses of TRC105 depending on when they enter the~          study, up to a maximum tolerated dose or optimum treatment dose.~        -  Frequent blood and urine tests will be performed during treatment, as well as other~          tests of cancer progression as directed by the study doctors. Participants will receive~          medicines to help prevent possible adverse side effects of TRC105, such as allergic~          reaction to the drug.~        -  Participants will continue treatment with TRC105 until they or the study team decides~          that the medication is not beneficial. No additional testing will be required unless~          participants discontinue the treatment because of side effects (which the study doctors~          will follow until the side effects are resolved).~   "
188991|NCT01090752|"~     This study examines the effects of pioglitazone on renal sodium handling in subjects prone to~     insulin resistance, i.e. diabetic and/or hypertensive subjects.~   "
188992|NCT01090739|"~     The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal~     incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day~     bowel diary at 12 months.~   "
188993|NCT01090726|"~     The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the~     equipment best suited to assist the intubation, with the best overview, shortest time to~     intubation and use these numbers to make a sample size calculation for the full protocol. The~     investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than~     infants (<2 years). The patients will be optimally anaesthetized with neuromuscular blockade~     for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with~     an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the~     later, which the patient was randomized to.~   "
188994|NCT01090713|"~     The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine~     compared with placebo in outpatients with binge eating disorder~   "
188995|NCT01090700|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg~     q.d., and vice versa. Steady state is a term which means that the drug has been given long~     enough so that the plasma concentrations will remain the same with each subsequent dose.~     TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection.~     Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the~     body and eliminated from the body.~   "
188996|NCT01090687|"~     The primary aim of this pilot study is to define the role of dedicated cone beam breast~     computed tomography in breast cancer imaging. This research is a prelude of a more~     comprehensive clinical trial that may follow.~   "
189021|NCT01090362|"~     The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is~     a pioneering real-world prospective registry - one of the largest in the field of~     non-valvular atrial fibrillation (AF). With an eventual enrolment target of 55,000 patients,~     GARFIELD-AF aims to enhance understanding of stroke prevention in patients with non-valvular~     AF worldwide and help in defining future treatment strategies that may eventually influence~     patient outcomes.~   "
189022|NCT01090349|"~     St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment~     or replace routine scheduled in-clinic visits.~      This investigation is designed with the hypothesis that detection of events (system integrity~     and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an~     earlier opportunity to address and resolve events and may therefore improve patient care.~   "
189032|NCT01090219|"~     The aim of this study was to analyze the shrinkage of two different screens in the repair of~     inguinal hernias in men . 32 patients with unilateral inguinal hernia were assigned randomly.~     A Lichtenstein tension-free hernia repair was accomplished by emplacing heavy weight versus~     ultralight weight polypropylene meshes for repair of incisional hernia, marked next to the~     lips with six titanium clips (LT200).~   "
189149|NCT01088685|"~     Study to evaluate the safety and performance of a new blister patch intended to treat~     blisters on the heel of the foot.~   "
188997|NCT01090674|"~     It is very important monitoring respiratory muscle function in patients with amyotrophic~     lateral sclerosis (ALS). We have at our disposal Respiratory Functional Tests (forced vital~     capacity (FVC), maximal mouth-inspiratory force (MIF), maximal mouth-expiratory force (MEF),~     Cough Peak expiratory flow (cPEF), maximal voluntary ventilation (MVV), arterial blood gases~     and nocturnal pulsioxymetry) and Thoracic Image Techniques (inspiratory/expiratory Thorax~     x-ray and x-ray scope). But all this explorations present some technique limitations. They~     are two new methods to explore diaphragmatic function: SNIF test and Diaphragm magnetic~     resonance imaging (dMRI). SNIF test is simple and easy to be done and it can avoid some~     problems that have the other respiratory functional test in this kind of patients. dMRI seems~     to correlate with respiratory functional test and it can be useful monitoring diaphragmatic~     mobility. The objective of our study is to compare and to correlate SNIF test and dMRI with~     x-ray techniques and respiratory functional tests that measure diaphragmatic force and~     function. First of all we will study 10 healthy people with a forced spirometry, MIF, MEF and~     dMRI, trying to obtain diaphragmatic mobility reference values with dMRI. Lately, we will~     study patients with ALS. In the first place, we will perform a transversal study with 30~     patients. We will do a forced spirometry, MIF, MEF, MVV, cPEF, SNIF, arterial blood gases and~     nocturnal pulsioxymetry, forced Inspiratory and expiratory Thorax x-ray, diaphragmatic x-ray~     scope and dMRI. Secondly, we will perform a prospective study, where we will analyze these~     variables evolution at 3 and 6 months. We hope we can apply the two new techniques in the~     future because we think they are simpler, more accurate and more objective to evaluate~     diaphragmatic mobility.~   "
188998|NCT01090661|"~     To assess the electrocardiogram (ECG) effects of mipomersen administered as a 200-mg~     subcutaneous (SC) therapeutic and a 200-mg intravenous (IV; [2-hour infusion])~     supra-therapeutic dose relative to placebo in healthy adult male and female subjects; and to~     evaluate the safety and pharmacokinetics (PK) of mipomersen when administered as a single~     therapeutic (200 mg) SC and a single, supra-therapeutic (200 mg) IV dose.~   "
188999|NCT01090648|"~     This trial is designed to assess the swallowability of uncoated and film-coated 200 mg~     etravirine tablets in HIV-1 infected patients. In addition, comparisons between a single 200~     mg tablet versus two 100 mg formulations will be made. The outcome of the trial will aid in~     making decisions about the future commercial 200 mg formulation.~   "
189000|NCT01090635|"~     The purpose of this study is to investigate the performance ability of the UltraSightHD™. The~     instrument will be assessed on characteristics such as focus quality, ability to image the~     entire cervix, and illumination. The information gathered from this study will provide data~     that will be used to determine which settings provide the best imaging outcome for the cervix~     for a simple screening instrument. Further, this information will serve as the foundation in~     the development of more advanced follow-on imaging devices.~      The primary objectives of this study are to:~        -  Determine if the light source provides sufficient illumination of the cervix.~        -  Assess focus and overall image quality.~        -  Assess the functionality and ergonomics of the instrument's design.~   "
189001|NCT01090622|"~     The purpose of this study is to determine whether XPF-001 is safe and effective in the~     treatment of pain caused by Inherited Erythromelalgia (IEM).~   "
189002|NCT01090609|"~     The objective this study is evaluate the performance and safety of Chronus® cobalt-chromium~     coronary stent in patients with de novo native coronary artery lesions treated with~     19-mm-long stents in long-term 9 months.~   "
189003|NCT01090596|"~     Using tissue samples obtained from a previous study, the effect of naproxen on the gene~     expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will~     be distinct changes in the gene expression profiles of samples taken from individuals treated~     with naproxen versus samples taken from individuals treated with placebo.~   "
189004|NCT01090583|"~     Preterm birth (birth before 37 weeks gestation) is a large problem in the United States and~     is a major cause of neonatal morbidity and mortality and childhood neurological disability.~     Despite significant advances in the care of pregnant mothers, the incidence of preterm labor~     is on the rise. There is growing recognition that cytokines and inflammatory mediators~     present at amniotic fluid and placenta play a fundamental role in regulating labor.~      Cytokines are chemicals in the fluid that tell the body's immune system what to do. These~     (and other biomarkers) can be measured with a small amount (a few drops) of amniotic fluid.~     The researchers have previously shown that people at risk for preterm labor have higher~     cytokine levels. However, understanding the in-utero environment currently requires invasive~     sampling, such as amniocentesis, to determine cytokine concentrations. This procedure has~     inherent risks, causes patient discomfort and anxiety, and thus does not avail itself to~     routine use or repeated sampling, especially in non-high risk patients. Therefore, the~     researchers are looking for non-invasive sampling that can predict the in-utero environment.~      To date, no studies have simultaneously evaluated different maternal-fetal compartments to~     determine the relationship of these markers among the compartments. Therefore, the purpose of~     this pilot study is to determine the differential expression of inflammatory mediators in~     various maternal-fetal compartments; specifically, vaginal fluid, cervical secretions,~     placenta, cord blood (arterial and venous), amniotic fluid, maternal serum, maternal urine,~     and maternal saliva.~      The researchers seek to obtain fluid samples from nine maternal-fetal compartments and~     determine the inflammatory mediator expression in each. The timing of collection, location,~     and proposed studies for each of the samples is outlined in Table 1. In this pilot study, we~     plan to enroll 20 patients undergoing cesarean delivery.~      After consent, the samples will be collected and given a unique Study ID number. No protected~     health information will be collected. In addition, there will be no link between the Study ID~     and patient identifiers. Therefore, we are not seeking HIPAA authorization at the time of~     consent. While none of these samples would routinely be collected as part of the standard of~     care, the collection procedures meet the criteria for minimal risk.~   "
189005|NCT01090570|"~     PLX3397 is a selective inhibitor of Fms and Kit activity. The objective of this study is to~     evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction~     (DDI) of orally administered PLX3397 during 2 weeks of dosing in patients with rheumatoid~     arthritis (RA) who are on maintenance methotrexate. This study is planned to provide data to~     inform dose selection for a subsequent 12 week dose ranging study in RA.~   "
189031|NCT01090232|"~     Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute~     hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where~     it is hyperendemic and principally water-borne. In industrialised western countries,~     hepatitis E was until recently considered as imported from hyperendemic geographical areas,~     but is currently an emerging autochthonous infectious disease. A growing body of data from~     Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis~     E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through~     direct or indirect exposure. Hepatitis E typically causes self-limited acute infection.~     However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be~     still higher in patients with underlying chronic liver disease. To date, no preventive or~     curative treatment of hepatitis E is available.~   "
189006|NCT01090557|"~     The fraction of exhaled nitric oxide (feNO) in expired air is a reliable measure of airway~     inflammation. Some research experiments have demonstrated stimulation of nitric oxide~     production in respiratory epithelial cells infected with RSV.~      The principal aims are to determine if the fraction of exhaled nitric oxide (feNO) is~     elevated in hospitalized pediatric patients with viral lower respiratory illness and to~     determine if there is a difference in feNO level between RSV and non-RSV infection.~      NO may play a role in the association between RSV, airway reactivity, and airway~     inflammation.~      This is a prospective, pilot study that will noninvasively measure feNO in children 0-4 years~     of age admitted to Winthrop University Hospital, as well as controls (children in the same~     age range without respiratory conditions and who are well enough to perform the test).~     Hospitalized children will be tested for RSV (enzyme immunoassay (EIA) & DFA) and via direct~     fluorescent antigen technique (DFA) for influenza A & B, parainfluenza, human metapneumovirus~     and adenovirus.~      Method of feNO measurement will utilize the offline options for preschool children & infants~     appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society~     & the European Respiratory Society when discussing tidal breathing techniques with~     uncontrolled flow rate Offline exhaled air can be collected via a mouthpiece or a face mask~     connected to a non-re-breathing valve that allows inspiration of NO-free air from an NO-inert~     reservoir to avoid contamination by ambient NO. Exhaled breath samples are collected into an~     NO-inert bag fitted with the expiratory port once a stable breathing pattern is present.~      The results of all 3 groups will be compared: control, RSV positive and RSV negative samples.~   "
189007|NCT01090544|"~     The purpose of this study is to determine wether transnasal insufflation as an alternate form~     of breathing support for COPD patients will lead to improvement of their medical condition.~   "
189008|NCT01090531|"~     This observational long-term follow-up study will evaluate demographic, clinical,~     histological, biochemical, and virological parameters of patients with chronic hepatitis B~     and low viremia who do not require antiviral therapy according to current guidelines. Liver~     stiffness values as detected by FibroScan and ARFI will also be collected if available. All~     data will be collected at yearly intervals (minimum). Patients included in the study are~     followed for up to 10 years. The target sample size is <1000.~   "
189009|NCT01090518|"~     This study seeks to examine the efficacy of hydrocortisone administration in the augmentation~     of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested~     treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD).~     The augmentation builds on both the translation of neuroscience findings demonstrating the~     effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other~     investigators demonstrating beneficial effects of GCs in reducing traumatic memories in~     trauma-exposed persons.~   "
189010|NCT01090505|"~     The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant~     chemotherapy may improve survival benefit compared with control.~   "
189011|NCT01090492|"~     The investigators propose that once daily administration of PF-00489791, a phosphodiesterase~     inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and~     Secondary Raynaud's Phenomenon.~   "
189012|NCT01090479|"~     We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of~     eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing~     the Chlorhexidine Cloths with a control group which will be performing an ordinary shower~     prior to surgery. At this time, it is standard of care to only take an ordinary shower the~     evening prior, and the morning of surgery.~   "
189013|NCT01090466|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Temsirolimus may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and cisplatin~     together with temsirolimus may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus~     given together with gemcitabine hydrochloride and cisplatin as first-line therapy in treating~     patients with locally advanced and/or metastatic transitional cell cancer of the urothelium.~   "
189014|NCT01090453|"~     This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine~     co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4~     months of age.~   "
189015|NCT01090440|"~     GSK1144814 is a potent, insurmountable antagonist at human neurokinin-1 (NK1) and~     neurokinin-3 (NK3) receptors with the potential to treat multiple symptom domains of~     schizophrenia and be an efficacious antidepressant.~      This study will be an open label, randomised, three-way cross-over study to evaluate the~     safety, tolerability and pharmacokinetics of a new tablet formulation of GSK1144814 and to~     evaluate the effect of food on single oral doses of GSK1144814 in healthy male and female~     subjects.~   "
189016|NCT01090427|"~     This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients~     with moderate to severe psoriasis.~   "
189017|NCT01090414|"~     This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with~     hematologic malignancies who complete other idelalisib studies. It provides the opportunity~     for patients to continue treatment as long as the patient is deriving clinical benefit.~     Patients will be followed according to the standard of care as appropriate for their type of~     cancer. The dose of idelalisib will generally be the same as the dose that was administered~     at the end of the prior study, but may be titrated up to improve clinical response or down~     for toxicity. Patients will be withdrawn from the study if they develop progressive disease,~     unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in~     the opinion of the investigator.~   "
189018|NCT01090401|"~     The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD~     lead.~   "
189019|NCT01090388|"~     The purpose of this study is to identify aspects of the bladder cancer (BlCa) survivorship~     experience that differ by clinical risk at diagnosis. The investigators will collect~     cross-sectional data from persons with BlCa to identify aspects of health-related quality of~     life (HRQOL) and symptom management. The study originally enrolled only nonmuscle-invasive~     bladder cancer survivors but has been expanded to include survivors with any stage disease.~     Information from this study will be used to develop a new patient education and counseling~     intervention.~   "
189023|NCT01090336|"~     Background: Both prasugrel and clopidogrel are prescribed drugs which compete as platelet~     inhibitors in patients with acute coronary syndrome (ACS). Whether rates of drug~     resistance/hyporesponsiveness are lower with prasugrel and whether more consistent and~     earlier onset of platelet inhibition may reduce infarct size in patients with ACS undergoing~     early PCI remains, at present, unknown.~      Study design/study population: This trial is a prospective, open-label, single centre~     observational trial. Patients receive either prasugrel (60mg) or clopidogrel (600mg) at the~     discretion of the attending cardiologist. Patients with exclusion criteria for prasugrel will~     be excluded for clopidogrel as well. The study population includes 80 subjects with moderate~     to high-risk ACS, ie patients with unstable angina (UA) and non-ST-segment elevation MI~     (NSTEMI) and TIMI risk score of 3 or higher, within 72 hours after onset of symptoms. In all~     patients early PCI is planned.~      Study objective/endpoint/methods: The primary objective of this trial is to evaluate whether~     rates of hyporesponsiveness are lower with prasugrel and whether more consistent and earlier~     onset of platelet inhibition may reduce infarct size in ACS in patients undergoing early PCI.~      The primary endpoint is the rate of drug resistance at time of index intervention. Optical~     and impedance aggregometry using ADP (5 and 20 μM) and collagen (1 μg/ml) as platelet~     agonists is used to measure platelet aggregation. Addition of the specific antagonists~     aspirin and mesamp to the probe is used to discriminate between pharmacodynamic and~     pharmacokinetic drug resistance.~      Secondary endpoint is the reduction of myocardial infarct size determined by~     post-interventional increase of high sensitive TnT (TnT hs) during the days following the~     index event reflecting earlier, more effective and more consistent inhibition of platelet~     function.~      Tertiary endpoint is the composite clinical endpoint of cardiovascular death, nonfatal MI, or~     stroke and urgent target vessel revascularization during hospitalization and after 6 and 12~     months.~      Safety endpoint is any TIMI major or minor bleeding during hospital stay and after 6 and 12~     months including intracranial and life-threatening bleeding.~   "
189024|NCT01090323|"~     The safety, tolerability, effects on liver iron concentration and pharmacokinetics of ICL670~     is studied in sickle cell disease patients with transfusional hemosiderosis.~   "
189025|NCT01090310|"~     This extension study will assess the safety and efficacy of AIN457 versus placebo for~     maintaining uveitis suppression when reducing systemic immunosuppression~   "
189026|NCT01090297|"~     Background: Continuous positive airway pressure (CPAP) is the first line therapy for~     obstructive sleep apnea syndrome (OSAS). Two positive airway pressure (PAP) modalities can be~     used: Fixed pressure, in which the effective pressure is set and kept constant all night, and~     auto CPAP devices where the positive pressure changes during the night depend on patient's~     requirements.~      Hypothesis: Pressure variations associated with autoCPAP functioning can lead to sleep~     fragmentation and alterations in sleep structure. This can limit blood pressure dipping~     during sleep and then impact clinical blood pressure reduction.~      Main objective: To compare in a randomized controlled trial 4 months clinical blood pressure~     (BP) evolution depending on CPAP mode: fixed pressure versus autoCPAP. Secondary outcomes:~     Evolution of arterial stiffness, biological parameters, quality of life and symptoms.~      Methods: Patients will be randomised depending on CPAP mode. Baseline and 4 months evaluation~     will include: 24-h ambulatory blood pressure monitoring, clinical BP measurements and~     carotid-to-femoral pulse wave velocity (PWV). Patients will also complete quality of life and~     symptoms questionnaires.~      2 interim analysis will be carried out when 150 and 220 patients respectively will have~     completed the study. The Peto's method will be used to correct the p-values.~   "
189027|NCT01090284|"~     The notable development and diffusion of prosthetic surgery of the abdominal wall over the~     last few years has led to the introduction of light weight meshes. The efficacy of inguinal~     hernia repair with light weight prosthesis, as well as the better or worse biotolerability~     with respect to those of light weight, remains questionable in literature, where a clear~     answer still remains to be given. If there exists a connection between the quantity of~     material implanted, the immunological reaction to the mesh, the induced oxidative stress and~     the degree of cicatrization, and consequently the long-term result of the efficacy of the~     operation, remains to be demonstrated. There are few studies on the immunological reaction to~     polypropylene meshes, and none on the oxidative stress induced by the mesh. Moreover, only~     one study has been published that clearly correlates the immunological reaction to the amount~     of prosthetic material, but was carried out on only a few patients.~      The aim of this research is to show if there is a relationship between the amount of~     prosthetic material used and immunological reactions as well as postoperative oxidative~     stress, and thus to evaluate, if present, the differences in the biological reaction and~     biotolerability between light-weight and heavy-weight meshes on a statistically significant~     number of patients.~   "
189028|NCT01090271|"~     The aim of the study was to evaluate the effect of eccentric strength training for shoulder~     abductors on force steadiness in subjects with subacromial impingement syndrome (SIS).~   "
189029|NCT01090258|"~     The study compares automated settings (Intellivent) with protocolized settings of the~     ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory~     and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated~     settings are feasible and safe.~      The study design is a randomized controled study. 30 patients will be ventilated with~     automated mode and 30 patients with protocolized settings after cardiac surgery.~      The hypothesis is that the automated mode allows a safer ventilation with better maintain of~     the patient in predefined optimal zone of ventilation.~   "
189030|NCT01090245|"~     Under funding from the National Institute on Drug Abuse, the UCLA Integrated Substance Abuse~     Programs (ISAP), in collaboration with Walden House and the California Department of~     Corrections and Rehabilitation, is conducting a five-year study that will involve a~     randomized test of the use of incentives with parolees in a community-based residential~     substance abuse treatment program to increase treatment admission and treatment retention,~     and thereby increase the likelihood of improved outcomes. Study participants will be~     recruited from clients in a prison-based treatment program who have a referral to the Walden~     House community program. The Admission Phase of the study assesses the effect of an incentive~     (voucher) on enrolling in the Walden House program. The Attendance Phase assesses the effect~     of incentives on treatment attendance and on post-treatment drug use, crime, and psychosocial~     behaviors, including HIV risk behaviors. In addition, an incentive protocol will test whether~     an incentive will encourage participation in HIV testing and counseling. The intervention~     will last for six months.~      Hypothesis 1. The use of incentives will significantly increase subject enrollment in~     community treatment.~      Hypothesis 2. The use of incentives will significantly increase subject retention in~     community treatment.~      Huypothesis 3. The use of incentives will significantly increase subject participation in HIV~     testing and counseling.~      Study participants will be interviewed at baseline and at 12 months following the~     intervention. Treatment and criminal justice data will be obtained. Data on acceptability,~     satisfaction, and sustainability will be collected from focus groups with staff and clients.~   "
189033|NCT01090206|"~     Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone,~     osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical~     activity assessment of boys with hemophilia A or B (ages 2-20 yrs). Patients with low vitamin~     D levels will receive therapeutic doses of Vitamin D. At end of one year follow up studies~     will be repeated.~   "
189034|NCT01090193|"~     Introduction: Cholemia and bacterial translocation with portal endotoxemia are integral in~     the pathogenesis of obstructive jaundice (OJ). There is sufficient experimental data about~     hemodynamic and histopathologic consequences of OJ. On the contrary, pathologic information~     of renal changes in patients with OJ is still lacking. Therefore; the primary objective of~     this prospective study is to demonstrate the specific histopathologic changes in kidneys of~     patients with short-term biliary tract obstruction receiving a standard perioperative medical~     treatment protocol.~   "
189035|NCT01090180|"~     The purpose of this study is to examine the effects of glucocorticoid administration~     following traumatic memory reactivation on psychiatric symptoms in veterans with~     combat-related PTSD, in addition to examining the effects of glucocorticoid administration~     following traumatic memory reactivation on physiological responses to veteran's personal~     combat memories. The following hypotheses will be tested:~        1. Subjects who receive an exogenous glucocorticoid after traumatic memory reactivation~          will demonstrate fewer PTSD and depression symptoms one week later, compared to those~          who receive a placebo after traumatic memory reactivation.~        2. The glucocorticoid reduction effects will be cumulative; that is, reduction will~          persist, and further post-reactivation glucocorticoid administration will further reduce~          symptoms~        3. Decreases in PTSD and depression symptoms will persist at 1, 3, and 6 months for~          subjects receiving an exogenous glucocorticoid compared to those subjects receiving~          placebo~        4. Subjects who receive an exogenous glucocorticoid after traumatic memory reactivation~          will demonstrate decreased physiological responses one week later, compared to those who~          receive a placebo after traumatic memory reactivation.~        5. As with the psychological measures, suppression of the physiological measures will~          demonstrate both persistence over time and accumulation with subsequent~          post-reactivation glucocorticoid administration.~   "
189036|NCT01090167|"~     This study is sponsored by Genzyme Japan K.K. The purpose of this study is to assess the~     safety, tolerability and pharmacokinetics of Clofarabine (JC0707) intravenously administered~     to Japanese adult patients with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia~     (AML) at 20, 30, and 40 mg/m2/day on a 5-day dose schedule.~   "
189037|NCT01090154|"~     The purpose of this study is to determine if Cimzia (certolizumab pegol) is an effective~     treatment for patients with Ulcerative colitis.~   "
189038|NCT01090141|"~     The purpose of this study is to assess the drug concentration of Micafungin amongst healthy~     volunteers having different weight groups.~   "
189039|NCT01090128|"~     The purpose of this clinical trial is to test whether treatment of patients with breast~     cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and~     Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24~     patients may be enrolled in this study at the Mitchell Cancer Institute. All patients~     enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin,~     and Cyclophosphamide.~   "
189040|NCT01090102|"~     The objective of this study is to determine whether 12 weeks of mesalamine therapy added to a~     standard HIV treatment decreases systemic immune activation and inflammation in HIV-infected~     patients, possibly resulting in better recovery of the immune system. The study hypothesis is~     that decreasing inflammation directly in the gut may decrease both of these potential causes~     of chronic inflammation, potentially resulting in an immunologic benefit.~   "
189041|NCT01090089|"~     In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until~     progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m²~     augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before~     transplantation and lenalidomide maintenance after transplantation.~   "
189042|NCT01090076|"~     This research aims to address the gap in the studies done and test the effects of a~     commercial mixture of 7 g of Arginine, 7 g Glutamine and 1.2 g HMB* twice a day on hard to~     heal pressure ulcers in an Asian patient cohort in an acute healthcare setting.~   "
189043|NCT01090063|"~     The purpose of this study is to determine the short and long term safety and effectiveness of~     ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.~   "
189044|NCT01090050|"~     This study is being conducted to evaluate the hypothesis that use of Treximet in patients~     with chronic migraine, when used on a short term daily basis and as rescue for break through~     attacks, will reduce migraine frequency and impact.~   "
189045|NCT01090037|"~     In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as~     the primary disease:~        -  To confirm the superiority of TRK-100STP over placebo~        -  To determine the recommended therapeutic dose in the 2 doses of TRK-100STP~        -  To assess the safety of TRK-100STP~   "
189046|NCT01090024|"~     To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening~     (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid~     in symptomatic asthma patients.~   "
189073|NCT01089673|"~     A retrospective molecular diagnostic review on wound care outcomes between two time periods.~     The time periods include June, July, August of 2008 and June, July, August of 2009. The~     retrospective review would analyze the days of healing during those two timeframes, upon the~     introduction of molecular diagnostic testing.~   "
189074|NCT01089660|"~     This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine~     in healthy adults given a lower vaccine dose and in a similar group given a full dose of the~     vaccine.~      The primary objective is to describe describe the immune response of the inactivated,~     split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.~   "
189075|NCT01089647|"~     In children with mild apnea combined therapy with an inhaled nasal steroid and a medication~     that decreased nasal congestion (montelukast) was shown to be effective. We are testing to~     see if this combination works in adults with mild apnea as well.~   "
195664|NCT01002274|"~     This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who~     have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be~     eligible for this study.~   "
189047|NCT01090011|"~     The primary objective of this trial is to determine the maximum tolerated dose (MTD) and~     recommended Phase II doses for the combination of BIBW 2992 and cetuximab in patients with~     non-small cell lung cancer and acquired resistance to erlotinib or gefitinib.~      Overall safety, pharmacokinetics and anti-tumor activity for the combination of BIBW 2992 and~     cetuximab in patients with non-small cell lung cancer and acquired resistance to erlotinib,~     gefitinib or BIBW 2992 will be evaluated as secondary objectives.~      Initially a standard, 3+3 dose escalation will be performed to determine the MTD of BIBW 2992~     when administered together with cetuximab in patients with advanced non small cell lung~     cancer and acquired resistance to erlotinib or gefitinib.~      Subsequently, the preliminary efficacy and safety of the identified MTD of cetuximab~     administered with BIBW 2992 will be explored in a combo arm via a further expansion of MTD~     cohort up to a total of 140 EGFR mutation positive NSCLC with acquired resistance to~     erlotinib/gefitinib.~      Furthermore, the safety and preliminary anti-tumor activity of the combination therapy in~     EGFR mutant NSCLC patients who developed acquired resistance (AR) to BIBW 2992, will be~     assessed in a sequential arm. The sequential arm will use a two-stage design with an early~     stopping rule after 12 patients with acquired resistance to BIBW 2992 have received up to 5~     courses of BIBW 2992 plus cetuximab. If no responses are seen in 12 patients during 5 courses~     of combination therapy, accrual in the sequential arm will stop. If 1 or more responses are~     observed, the sequential arm will expand up to about 40 patients.~   "
189048|NCT01089998|"~     Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)~     images obtained after a single intravenous injection of BAY86-9596 in patients with cancer~     and inflammation~   "
189049|NCT01089985|"~     The purpose of this study is to examine the efficacy and safety of autologous serum eye drops~     in people with recalcitrant dry eye.~   "
189050|NCT01089972|"~     The aim of this randomized study was to compare the impact of two different radial arterial~     catheters - 20G and 22G - on the changes of diameter, blood flow and velocity of radial~     artery and ulnar artery after induction of anesthesia and after cannulation.~   "
189051|NCT01089959|"~     The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only~     nighttime symptoms but also significantly reduces conscious awakenings associated with~     gastroesophageal reflux and consequently improves sleep quality.~   "
189052|NCT01089946|"~     The purpose of this study is to investigate the cardiovascular changes during early~     postoperative mobilization of hip arthroplasty patients.~   "
189053|NCT01089933|"~     The purpose of this study is to determine if the combination of thoracic paravertebral block~     and multimodal analgesia will decrease chronic pain and arm morbidity in patients undergoing~     breast cancer surgery with lymph node dissection as compared to patients receiving local~     anesthesia with multimodal analgesia.~   "
189054|NCT01089920|"~     Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant~     compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of~     catechins is somewhat known and has been referenced in the literature. However,~     bioavailability data from tea infusion is non-existent, even though it reflects better how~     consumers drink this beverage. In addition, bioavailability of coffee chlorogenic acids is~     less understood and no dose response study has been reported so far in the literature. Thus,~     there is a great need to understand and reinforce our knowledge on the bioavailability of~     coffee and tea polyphenol compounds.~   "
189055|NCT01089907|"~     To study the genomics with cell cycle and lymphocyte differentiation in disease, remission~     and relapse of childhood acute lymphoblastic leukemia. Then correlate these data with age,~     white cell count, cytogenetic changes, response to the chemotherapy and prognosis.~   "
189056|NCT01089894|"~     The ability of 18F-FDG PET for characterizing lung nodule remains a challenge, especially in~     Taiwan where tuberculosis is still prevalent.~      18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT), a radiolabeled analog of thymidine, can be~     trapped within the cytosol after being monophosphorylated by thymidine kinase-1 (TK-1), a~     principle enzyme in the salvage pathway of DNA synthesis. It has been demonstrated in cell~     culture, animal models and clinical studies that the accumulation of 18F-FLT is closely~     associated with cellular proliferation. 18F-FLT PET may be more accurate than 18F-FDG PET in~     differentiating benign from malignant pulmonary lesions. In addition, the correlation between~     18F-FLT uptake and cellular proliferation hints the usefulness of 18F-FLT PET for monitoring~     treatment response with cytostatic anticancer drugs.~      We thus design this prospective 3-year project~        1. To evaluate the usefulness of 18F-FLT PET and 18F-FDG PET in differentiating benign from~          malignant pulmonary nodules in Taiwan where tuberculosis is still prevalent.~        2. To assess the usefulness of 18F-FLT PET in early prediction of therapeutic response of~          platinum-based chemotherapies or EGFR inhibitors for NSCLC patients.~        3. To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival~          for NSCLC patients.~   "
189057|NCT01089881|"~     Choline is one of the components of phosphatidylcholine, an essential element of~     phospholipids in the cell membrane. Some malignant cells show their ability to actively~     incorporate choline to produce phosphocholine and phosphatidylcholine to facilitate tumor~     cell duplication. The efficacy of 18F-fluorocholine (18F-FCH) for localizing primary or~     metastatic prostate cancer has been recently reported in limited studies. This study will be~     conducted to delineate the effectiveness of 18F-FCH PET in (1) differentiating benign~     prostate hypertrophy (BPH) from prostate cancer, (2) staging prostate cancer, (3)~     following-up patients with prostate cancer after initial curative therapy.~   "
189058|NCT01089868|"~     The aim of this study is to establish FET-PET as an additional therapy assessment parameter~     in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant~     chemotherapy after previous resection or biopsy.~   "
189059|NCT01089855|"~     The trial is designed to evaluate the efficacy and tolerability of carbamazepine in~     neuropathic pain in diabetic patients~   "
189060|NCT01089842|"~     The purpose of this study is to evaluate the efficacy of motivational interviewing-based~     coaching to increase physical activity to achieve guidelines recommendations for~     cardiovascular disease prevention.~   "
189150|NCT01088672|"~     To determine the revascularization rate of the CE-marked Trevo device in large vessel~     occlusions in ischemic stroke patients.~        -  Revascularization, defined as at least TICI 2a in the vascular territory treated at end~          of the neuro interventional procedure.~   "
189061|NCT01089829|"~     Foot ulceration is a risk factor that has been associated with early death in patients with~     chronic kidney disease. Little is known about the relationship between these risk factors~     that develop in patients with kidney failure and the onset of lower limb threatening foot~     ulcers.~      Diabetes is a major cause of both kidney disease and foot ulceration; however a previous~     study reported that a significant proportion of kidney failure patients on haemodialysis~     treatment without a diagnosis of diabetes also had these risk factors that could lead to foot~     ulceration.~      The aim of this study will be to identify these risk factors associated with lower limb~     threatening disease in patients with advanced kidney failure. In addition a robust screening~     tool will be developed to address the reliability and validity of current screening methods~     deemed to be gold standard in the assessment of diabetic foot disease in this Chronic Kidney~     Disease population.~      It is important to follow the progression of these risk factors as the kidney failure~     worsens. The study also intends to screen patients as they start dialysis treatment and~     follow their progress with respect to risk factors known to predispose to foot ulceration~     over their first year of treatment. The proposed outcome from this study is to develop a~     strategy to identify patients with kidney failure that are at risk of foot ulceration and~     intervene at an early point to prevent the life threatening complications associated foot~     disease.~   "
189062|NCT01089816|"~     The primary objective of this study is to evaluate the performance of the MSD® Influenza Test~     in detecting influenza A and influenza B in subjects presenting with influenza-like-illness~     (ILI).~   "
189063|NCT01089803|"~     The purpose of this prospective, multi-institutional, observational cohort study is to~     determine if an initial surgical approach leads to better function and quality of life than~     primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal~     cancers.~   "
189064|NCT01089790|"~     This study will evaluate the long-term safety and efficacy of dutogliptin in patients with~     type 2 diabetes mellitus (T2DM).~   "
189065|NCT01089777|"~     The study is an open prospective study of coronary flow preferably of the left anterior~     descending artery (LAD), by a Transthoracic Parametric Doppler (TPD) system during~     conventional exercise stress test. The system is a noninvasive non-imaging device designed to~     monitor coronary flow velocity and display the data continuously during exercise stress~     tests. The system enables continuous monitoring of coronary flow during resting, stress~     loading and recovery phases. The study intent is to improve the stress test predictive value~     for CAD.~   "
189066|NCT01089764|"~     Women diagnosed with breast cancer (BC) at or before the age of 50 experience more distress~     and poorer quality of life than women diagnosed later in life. Although adequate spousal~     support is a protective factor for women with BC, spouses are often unprepared to handle the~     myriad practical and emotional demands posed by the illness. Furthermore, despite the growing~     number of recommendations for couple interventions in relation to BC, traditional counselling~     approaches may fail to meet the needs of young couples who have unique concerns and tight~     constraints on their time. The proposed project addresses the void in the psycho-social~     support available to young couples via an innovative, online psychoeducational intervention~     tailored specifically to their needs.~   "
189067|NCT01089751|"~     This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily~     in reducing urgency, urinary frequency and urinary urge incontinence in female patients with~     incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.~   "
189068|NCT01089738|"~     This study is designed to look at the safety and blood concentrations of PF-03382792 in~     healthy elderly subjects after taking multiple doses for 14 days.~   "
189069|NCT01089725|"~     This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab~     administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC)~     administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of~     tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16~     weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.~   "
189070|NCT01089712|"~     The purpose of the study is to determine the best ways to prevent infections after heart~     surgery. Participation in the study will last at most 3 months after heart surgery. The study~     will only collect information about the care patients receive during the planned surgery. No~     new testing or procedures will be done. Patients will receive only the tests or procedures~     the doctor already has planned. This kind of study is an observational study, because all~     that is planned to do is observe the care patients receive and how well they do during~     treatment. The information collected should help to improve the quality of surgical care in~     the future.~   "
189071|NCT01089699|"~     Young women who have finished treatment for breast cancer regularly report a lack of~     psychological and social support in their lives. They often continue to struggle with~     survivorship issues such as ongoing distress and the challenge of how to rebuild their lives~     after treatment. This experiment will compare two online support group (OSG) options to~     determine if both forms of support help young breast cancer survivors adjust, by reducing~     treatment-related intrusions and helping women re-engage in valued activities and~     commitments. It will also test if these 2 types of OSG's help womens' mood, feelings of~     loneliness, confidence, and overall life satisfaction. It will explore the processes within~     support groups that help to create positive change for young women after cancer treatment.~      Previous work by this team in a smaller study has shown that online support groups led by~     professional counselors can be carried out over the Internet, and that they produce helpful~     benefits for young women survivors of breast cancer. The online groups were comprised of 10~     sessions of real time chats, with each session focused on a specific topic. Participants were~     provided with an educational manual designed to improve skills for coping after cancer, and~     they were instructed to read one chapter a week in preparation for the chats. The women~     enjoyed the groups and 3 months after completing the groups, they reported improved quality~     of life, lower emotional distress, and enhanced coping. However, a large study to determine~     the strength and reliability of these early promising findings is needed. The questions to be~     examined are whether trained peers (other young breast cancer survivors) might be able to~     facilitate the online groups and provide similar positive benefits for young breast cancer~     survivors, and what facilitators can do to maximize positive benefits in online support~     groups.~      This is a multi-provincial, 3-arm study that will compare a professionally-led OSG (with an~     educational manual) and a peer-led OSG (with an education manual) with a group that just~     receives the educational manual. Psychological assessment measures given immediately~     following the 12 week group, and at 6 months and 12 months follow-up, will determine if one~     or both of the study groups effectively improve quality of life, reduce distress, and enhance~     self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests~     will be performed to investigate whether discussing emotional matters predicts greater~     improvements.~   "
189072|NCT01089686|"~     This is a single center, multispecialty, randomized double blind placebo control feasibility~     clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of~     percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions,~     and its influence on the clinical outcomes of Multiple Sclerosis (MS) patients that have been~     found to have chronic cerebrospinal venous insufficiency (CCSVI).~   "
189076|NCT01089634|"~     Primary Objective:~      To characterize left ventricular (LV) threshold behavior over time using daily left~     ventricular capture management (LVCM) measurements.~      Study Design:~      This is a multicenter, prospective, non-interventional study with patients receiving their~     first cardiac resynchronisation therapy-implantable cardioverter defibrillator (CRT-ICD)~     device. The study design, based on the primary objective, is an observational examination of~     LV thresholds over time. Daily left ventricular threshold measurements will be collected~     using the LVCM feature. Up to 150 patients will be enrolled in Canada to evaluate the primary~     objective at up to 15 study centers.~      Data will be collected at Baseline, Implant, 12 months post-implant and all regularly~     scheduled follow-up visits up to 12 months post-implant.~      Devices:~      The ConcertoTM CRT-ICD device and future Medtronic CRT-ICD devices containing the LVCM~     feature will be used in this study.~   "
189077|NCT01089621|"~     The purpose of this study is to evaluate the possibility of conducting a larger study in~     adolescents with fibromyalgia syndrome.~   "
189078|NCT01089608|"~     The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus~     placebo eye drops on the global ocular discomfort (VAS).~   "
189079|NCT01089595|"~     Patients with advanced GIST are treated with imatinib. This study seeks to look at a new~     therapeutic agent at the time of tumor progression following treatment with 600-800 mg daily~     of imatinib. The study is looking to see if Nilotinib (tasigna) alone or in combination with~     imatinib (gleevec) is more effective at controlling disease.~   "
189080|NCT01089582|"~     This study assessed the Hr QoL (Health related Quality of life) of subjects with mild to~     moderate AD, who received ARICEPT under usual clinical practice.~   "
189081|NCT01089569|"~     The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns,~     HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of~     insulin glargine and exenatide to metformin.~   "
189082|NCT01089556|"~     This study will investigate the efficacy of a combination treatment of duloxetine +~     pregabalin compared with the maximal dose of each drug in monotherapy, in patients with~     diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard~     recommended dose of either drug. It will provide an answer to a common clinical question,~     namely, is it better to increase the dose of the current monotherapy or to combine both~     treatments early on, in patients who do not respond to standard doses of duloxetine or~     pregabalin.~   "
189083|NCT01089543|"~     The purpose of this study is to assess the efficacy and safety of rabeprazole compared to~     placebo in Japanese subjects with Functional Dyspepsia.~   "
189084|NCT01089530|"~     Objectives:~        -  To study the possible effects of an intensive lifestyle change program on, the plasma~          fibrinogen levels in patients with no cardiovascular disease, with a high fibrinogen and~          normal cholesterol levels, and moderate Cardiovascular Risk (CVR).~        -  To analyse whether or not the effect on fibrinogen is independent of the effect on~          lipids.~      Methods: Controlled, randomised clinical trial in 13 Basic Health Areas (BHA) in L'Hospitalet~     de Llobregat (Barcelona) and Barcelona city. Of the 436 patients between 35 and 75 years with~     no cardiovascular disease, with a high plasma fibrinogen (> 300 mg/dl) and a plasma~     cholesterol < 250 mg/dl, 218 received a more frequent and intensive intervention, consisting~     of advice on lifestyle changes and treatment. The follow up frequency of the intervention~     group was every two months. The other 218 patients continued with their usual care in the~     BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were~     assessed.~   "
189085|NCT01089517|"~     The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous~     injection when administered in combination with Lucentis® against a control of Lucentis®~     alone in subjects with subfoveal choroidal neovascularization secondary to age-related~     macular degeneration (AMD).~   "
189086|NCT01089504|"~     The treatment of infants with medications after their seizures have stopped is very variable.~     No one knows if continuing treatment with phenobarbital for up to several months is helpful~     or harmful. This clinical trial is designed to help answer that question and provide data~     that will help determine standard of care for these children.~   "
189087|NCT01089491|"~     The purpose of this study to determine if cells collected give us information about what is~     causing a patient pain can be detected and connected with epiduroscopy images (pictures taken~     with a small fiber optic scope). We want to determine if abnormal areas are the source of~     that pain by using a catheter to provide a brief, low intensity electrical stimulation. We~     also want to determine if there are cells in the epidural cavity (area surrounding the spinal~     cord) of patients who have low back pain with or without pain shooting down one or both legs~     that provide information about what is causing the pain.~   "
189088|NCT01089478|"~     The investigators are doing this study to learn more about the cause of back pain with or~     without pain shooting down one or both legs. The investigators specifically want to know if~     cells that move into injured areas of the body are present in a space in the spine (epidural~     space) of patients with back pain and with or without shooting pain. The investigators will~     collect cells when patients are being treated, then examine the cells using a microscope. The~     investigators also will shine different colors of light into the epidural space to see if~     there is a correlation between how different colors of light are reflected and the types of~     cells present.~   "
189089|NCT01089465|"~     During the last years, the investigators were the witness to the increase of a old emerging~     pest due to bed bugs (Cimex lectularius) in the world. Insecticides resistances apparitions~     and internationals transports increases seem to be the reasons of the pest. Cimex lectularius~     as vector of parasites, bacteria or virus was often suggested although not much observation~     are recently investigated in France. This study intends to examine the vectorial ability and~     the direct pathogenicity of Cimex lectularius.~   "
189112|NCT01089166|"~     Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test~     formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference~     formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting~     condition.~      Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting~     condition.~   "
189193|NCT01088113|"~     The objective of this study is to investigate the effect of Tai Chi and Qigong practice on~     cranial oxyhaemoglobin level, blood pressures and autonomic nervous system responses.~   "
189090|NCT01089452|"~     This study is looking to evaluate which drug combination, olmesartan/amlodipine or~     perindopril/amlodipine, is better at lowering blood pressure in people with mild to moderate~     hypertension. The investigators will be enrolling people who are either currently taking~     medication to lower their blood pressure or who have been recently diagnosed with high blood~     pressure and are not yet on medication.~      Patients on medication for their blood pressure will be asked to stop taking this medication~     for 2 to 4 weeks. If their blood pressure is suitable (not too high or low) they will be~     randomised to one of their treatment arm:~      Group 1 will receive Perindopril on its own (5mg for 4 weeks followed by 10mg for 8 weeks).~     There will be 80 patients in this group.~      Group 2 will receive Perindopril and Amlodipine together (5mg/5mg for 4 weeks, 10mg/5mg for a~     further 4 weeks then 10mg/10mg for the final 4 weeks). There will be 80 patient in this~     group.~      Group 3 will receive Olmesartan and Amlodipine together (20mg/5mg for 4 weeks, 40mg/5mg for a~     further 4 weeks then 40mg/10mg for the final 4 weeks). There will be 120 patients in this~     group.~      During the study we will measure the patients blood pressure and heart rate, weight and~     perform routine blood tests. They will also have ECGs (3 occasions) and 24 hour blood~     pressure monitor (4 occasions).~      At the end of the study patients pre-study medication will be restarted or they will be put~     on to a suitable alternative.~   "
189091|NCT01089439|"~     Acute chest syndrome is a severe sickle cell disease complication in children requiring blood~     transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent~     vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation.~     The randomized trial will test that hypothesis.~   "
189092|NCT01089426|"~     This study examines the hypothesis that administering intravenous fish oil, in lieu of~     intravenous soybean oil, can ameliorate the progression of PN-associated cholestatic liver~     disease in pediatric patients with elevated direct bilirubin requiring PN for more than 30~     days.~   "
189093|NCT01089413|"~     This observational study will assess the treatment duration, progression-free survival,~     reason for stopping treatment and patient and tumor characteristics of bevacizumab [Avastin]~     treatment in patients with metastatic colorectal cancer. Data will be collected for~     approximately 34 months. The target sample size is >300 patients.~   "
189094|NCT01089400|"~     The influenza A/H1N1v pandemic virus causes severe pneumonia that can lead to acute~     respiratory distress syndrome and death even in healthy young individuals. The respective~     roles of viral replication, bacterial infection and immune alterations of the host during~     such severe influenza H1N1v infection need to be clarified in order to optimize patients~     care. In this context, we aim to study immune and virological parameters in bronchoalveolar~     lavage fluid during severe influenza A/H1N1v infection with pulmonary involvement in~     intensive care unit. Results will be correlated to bacterial or viral pulmonary co-infections~     and to peripheral blood immune and virological parameters.~   "
189095|NCT01089387|"~     Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate~     cancer.~      It is the consequence of penile vascular damage, mainly arterial insufficiency and venous~     leakage associated with fibrosis of the corpus cavernous. Apoptosis of penile cells,~     including mesenchymal cells, smooth muscle cells and endothelial is believed to play an~     important role in the pathophysiology of post prostatectomy erectile dysfunction.~      Bone marrow mononucleated cells (BMMNC) contain different cell types that may replace the~     damaged penile cells after radical prostatectomy. These are mainly: mesenchymal stem cells,~     endothelial progenitor cells and hematopoietic stem cell. Intracavernous injection of BMMNC~     may therefore find application in the treatment of post prostatectomy erectile dysfunction.~      The aims of this phase I-II study is to test the safety of autologous intracavernous BMMNC~     injection and to evaluate benefit for the patient concerning recovery of natural erection.~     Patients with penile vascular abnormality (echo-doppler) and localized prostate cancer~     (considered as cured by radical prostatectomy) will be included in this study.~      Four different doses of BMMNC will be tested.~   "
189096|NCT01089374|"~     In 2008 a research study conducted by Dr. Barth involving 46 women determined that whole~     breast radiation therapy performed after a lumpectomy of borderline and malignant phyllodes~     tumors decreases rate of recurrence. None of the 46 participants developed a local~     recurrence.~      Based on information we have learned from research studies, we recommend whole breast~     radiation therapy for women with malignant and borderline phyllodes tumors after they receive~     a lumpectomy.~      New methods for delivering breast radiotherapy are being developed that allow radiation to be~     delivered solely to the site of the surgical resection. This is called partial breast~     radiation. The main advantage of partial breast radiation is that it simplifies treatment for~     the patient. Radiation is delivered twice a day for 5 days, rather than 5 days per week for 6~     weeks. The main concern is that partial breast radiation might miss other sites of breast~     cancer in the breast receiving the radiation.~      Evidence is accumulating from research studies that partial breast radiation therapy after~     surgical removal of the more common type of breast cancer, invasive ductal carcinoma, the~     breast results in rates of local recurrence that are comparable to those seen after whole~     breast radiation therapy.~      In contrast to patients with invasive ductal cancers of the breast, it is very rare for~     patients to have phyllodes tumors that appear in more than one area of the breast. Review of~     research data determined that cancer recurrences seen in patients with phyllodes tumors that~     had undergone lumpectomies were almost always at the original tumor site. Therefore, partial~     breast radiation is likely to be as effective as whole breast radiation therapy after~     resection of malignant phyllodes tumors.~      The purpose of the study is to determine what the chances are that a phyllodes tumor will~     recur in the breast when the breast is treated with partial breast radiation therapy after a~     lumpectomy.~   "
189097|NCT01089361|"~     The aim of the study is to assess the effect of short-term infusion of ketamine at analgesic~     dosage on the immune response, morbidity and mortality among patients suffering from septic~     shock. We hypothesize that ketamine will modulate the cytokine response to sepsis and reduce~     morbidity and mortality.~   "
189098|NCT01089348|"~     This is a phase II multicenter randomized open-label clinical study that will determine~     whether treatment with Lactofiltrum (orally administered tablets) in combination with~     antibiotic therapy (metronidazole) is effective in women with bacterial vaginosis.~     Lactofiltrum is a composite drug that includes enterosorbent lignin and prebiotic Lactulose.~     It's supposed that supplement of Lactofiltrum to a standard therapy of bacterial vaginosis~     (metronidazole administered orally) improves women's general state, leads to better recovery~     of clinical, microbiological, biochemical and histological features of the disease.~   "
189113|NCT01089153|"~     Current spirochaete infection identification and diagnostic strategies have important~     limitations. Recent development may allow for an improvement in diagnostic, screening and~     survey capabilities. The goal of this study is to evaluate blood, urine and fecal samples~     from a variety of sources and generate information on the occurrence and epidemiology of~     spirochetes in the general and at risk populations.~   "
189114|NCT01089140|"~     Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion~     requirement in pediatric patients with secondary scoliosis undergoing posterior spinal~     fusion.~   "
189099|NCT01089335|"~     The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm~     according to recent national and international guidelines, is total thyroidectomy and central~     lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear~     malignant potential hemithyroidectomy on the side of the tumour.~      The study investigates if the sentinel lymphnode (SN)~        -  Reliably (with high sensitivity and specificity), can predict the pathological findings~          of the lymphnodes in the central compartment in patients with highly differentiated~          papillary thyroid cancer~        -  Is useful to aid in the final diagnosis and staging of thyroid neoplasias of unclear~          malignant potential, and could be used to select patients for further central lymphnode~          revision.~   "
189100|NCT01089322|"~     Several studies have demonstrated the efficacy of asthma treatment but despite being~     correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of~     asthmatics do not reach disease control.~      The aim of this study is to measure asthma control, evaluate inflammatory and functional~     characteristics, describe comorbidities and aggravating factors and phenotypes derived from~     the characteristics of a severe asthmatic population followed at an outpatient university~     service in Sao Paolo, Brazil.~   "
189101|NCT01089309|"~     The present study investigated the long-term (12 months) effect of spironolactone treatment~     on glucose homeostasis, metabolic parameters and vascular properties.~   "
189102|NCT01089296|"~     This is a pragmatic randomized controlled study. The purpose of the study is to evaluate the~     practice and effect of customised physiotherapy on preterm infants`motor development when the~     intervention is performed over a period of three weeks while the infant resides in the~     neonatal intensive care unit. The study will also attempt to analyze the parents` experiences~     in being actively involved in education and practice of the intervention designed to promote~     the child`s motor development, and the effects on the parent-child relationship in the short~     and long term.The children are followed up until a corrected age of two years. This study~     consists of a pragmatic randomized controlled trial and a qualitative study.~   "
189103|NCT01089283|"~     Parkinson disease is one of the most common neurodegenerative illnesses. The disease is~     characterized by decrease in dopamine levels and decrease in the number of dopaminergic~     neurons and dopamine receptors. There are gene mutations that increase the risk for the~     disease. Two of those mutations are on the LRRK2 gene and on GBA gene. It is yet unknown if~     there is a difference between the metabolic brain function of Parkinson patients that carry~     one of the two mutations to Parkinson patients with no known mutation.~      Participants: diagnosed Parkinson patients that carry a gene mutation in either LRRK2 or GBA~     genes, Parkinson patients with no known mutation and healthy volunteers as a control group.~      The participants will go through both examinations DAT SCAN and PET CT SCAN at the Tel Aviv~     Sourasky Medical Center Nuclear Medicine Institute.~      The examination results will be given to the participants by a doctor from the neurology~     department.~   "
189104|NCT01089270|"~     Parkinson Disease is one of the most common neurodegenerative illnesses. First degree~     relatives of Parkinson patient are in high risk for developing the disease. We will try to~     detect early changes in brain metabolism before the appearance of Parkinson symptoms.~      Participants: first degree relatives of diagnosed Parkinson patients that carry a gene~     mutation in either LRRK2 or GBA genes.~      The examination results will be given to the participants by a doctor from the neurology~     department.~   "
189105|NCT01089257|"~     Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep~     (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or~     functional precociously found among patients SAS? Secondary objectives:~        1. Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate~          occurred of early of the cardiac function and/or rhythmic anomalies found among patients~          SAS?~        2. Do there exist biological markers who allow to anticipate the early vascular lesions or~          the anomalies beginners of the cardiac function?~        3. Which are the cardiovascular effects of a treatment of SAS by Continuous Positive~          Pressure (PC) after 3 to 6 months of treatment?~        4. Do the identified early cardiovascular attacks and/or the biological anomalies make it~          possible to predict occurred of cardiovascular events in this population of patients~          carrying SAS (followed longitudinal at 5 years)?~   "
189106|NCT01089244|"~     The aim of the study is to compare the two imaging modalities perfusion weighted MR-imaging~     and FET-PET in their ability to provide an accurate histological evaluation of low grade~     glioma and to reveal focal abnormalities within a homogeneously appearing tumor.~     Additionally, therapeutic effects should be assessed during a time period of two years.~   "
189107|NCT01089231|"~     The aim of this study is to investigate the effects of short- and long-term intervention with~     EPA and DHA-rich fish oil on gene expression profiles in healthy and hyperlipidemic males.~   "
189108|NCT01089218|"~     Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients.~     We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of~     postbronchoscopic fever and pneumonia.~   "
189109|NCT01089205|"~     Objective:~      To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test~     formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet~     (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fed~     Conditions.~      Study Design:~      An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study~   "
189110|NCT01089192|"~     Objective:~      To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test~     formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet~     (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under~     Fasting Conditions.~      Study Design:~      An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study~   "
189111|NCT01089179|"~     Objective: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose~     Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test~     formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet~     (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed~     Conditions.~      Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed~     condition.~   "
189115|NCT01089127|"~     This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo~     and salmeterol.~   "
189116|NCT01089114|"~     Background:~      - Antiretroviral therapy has increased the lifespan of people with human immunodeficiency~     virus (HIV), but recent research suggests that people with HIV also have an increased risk of~     developing cardiovascular disease. To better understand the prevalence and effects of heart~     disease in people with HIV, researchers are interested in comparing heart imaging and~     metabolism studies to see if there are differences between HIV-positive and HIV-negative~     people.~      Objectives:~      - To study metabolism and heart function in people with HIV compared with healthy~     HIV-negative volunteers.~      Eligibility:~      - Individuals at least 18 years of age who either have been diagnosed with HIV or are healthy~     HIV-negative volunteers.~      Design:~        -  Participants will be evaluated with a physical exam, detailed medical history, and~          routine blood and urine tests including HIV testing.~        -  Participants will have the following imaging scans:~        -  Cardiac magnetic resonance imaging (MRI) to study the health of the heart and blood~          vessels~        -  Magnetic resonance spectroscopy (MRS) of the heart, liver, and skeletal muscle~        -  Cardiac computerized tomography (CT) scan to measure calcium levels in the heart and~          nearby arteries~        -  Dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle mass.~        -  Stable isotope infusion to evaluate how the body processes fat (which will require an~          overnight stay before the test)~        -  Participants will also have blood tests, an echocardiogram, and an electrocardiogram to~          evaluate heart function.~   "
189117|NCT01089101|"~     This phase I/II trial studies the side effects and the best dose of selumetinib and how well~     it works in treating or re-treating young patients with low grade glioma that has come back~     (recurrent) or does not respond to treatment (refractory). Selumetinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
189118|NCT01089088|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving~     gemcitabine hydrochloride and cisplatin together with sunitinib malate may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying the side effects of giving gemcitabine hydrochloride~     and cisplatin together with sunitinib malate and to see how well it works as first-line~     therapy in treating patients with locally advanced and/or metastatic transitional cell~     carcinoma of the urothelium.~   "
189119|NCT01089075|"~     The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy~     in patients with partial cortisol deficiency after traumatic brain injury or subarachnoid~     hemorrhage on cognitive function.~   "
189120|NCT01089062|"~     Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by~     Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.~   "
189121|NCT01089049|"~     The purpose of this study is to determine if a supplemental formula can beneficially alter~     the ratio of urinary estrogen metabolites.~   "
189122|NCT01089036|"~     We would like to investigate novel diagnostic methods or biomarkers to early predict the~     success of ECMO therapy for cardiogenic shock patients during the early stage after ECMO~     treatment.~   "
189123|NCT01089023|"~     This open-label single-arm study will evaluate the safety, tolerability and efficacy of~     tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who~     experience an inadequate clinical response to a stable dose of non-biologic disease modifying~     anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be~     administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be~     administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6~     infusions. The anticipated time on study treatment is 24 weeks. The target sample size is~     50-150 patients.~   "
189124|NCT01089010|"~     The primary objective of this study is to demonstrate a pharmacodynamic effect of CK 2017357~     on measures of skeletal muscle function or fatigability in patients with ALS.~   "
189125|NCT01088997|"~     The purpose of this pilot study is to determine a safe dose of milrinone to use in a larger~     study of babies with persistent pulmonary hypertension of the newborn (PPHN).~   "
189126|NCT01088984|"~     The primary objective of phase 1 of this study is to establish the recommended phase II dose~     (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy~     of bendamustine at the recommended pediatric dose for the treatment of pediatric patients~     with relapsed or refractory acute leukemia.~   "
189127|NCT01088971|"~     Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel~     syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in~     changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64~     patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre~     controlled clinical trial. Patients will be randomized to receive either 2 capsules/day~     Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to~     Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL)~     scores will be also monitored.~   "
189128|NCT01088958|"~     The purpose of the study is to evaluate the effectiveness of household-based distribution of~     evidence-based health products and to measure the health impact of these combined~     interventions on a population basis.~   "
189129|NCT01088945|"~     Infants born prematurely or with complex congenital abnormalities are surviving to discharge~     in growing numbers and often require significant monitoring and coordination of care in the~     ambulatory setting. The specific aims of this project are to determine the effectiveness of a~     redesigned discharge process that includes a Health Coach and an expanded discharge binder to~     improve health outcomes in the post discharge follow-up period as compared with usual care.~     The outcomes to be evaluated include the occurrence of adverse events in the post-discharge~     period, quality of follow up care, and caregiver satisfaction with the process.~   "
189130|NCT01088932|"~     This is a multiple dose clinical study to be conducted with SRX246 capsules to determine the~     safety, tolerability and pharmacokinetics of the drug over a 14 day dosing period.~   "
189131|NCT01088919|"~     The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics and safety~     following the administration of ASP1941 and pioglitazone hydrochloride in multiple and single~     doses.~   "
189133|NCT01088893|"~     This is a randomized controlled pilot study investigating signals involved in drug resistance~     to chemotherapy.~      Patient will be randomized to undergo observation or to receive Everolimus after completion~     of neoadjvuant treatment (anthracycline and/or taxane-based) and before surgery. The patients~     will be monitored for efficacy and safety.~   "
189134|NCT01088880|"~     Establish the safety and efficacy of 3 months treatment with canakinumab in patients with~     colchicine resistant Familial Mediterranean Fever.~   "
189135|NCT01088867|"~     The investigators hypothesize that acupuncture modifies the DNIC efficiency and that DNIC can~     serve as a predictor to identify 'good responders' to acupuncture early in therapy.~   "
189136|NCT01088854|"~     Acute effects of CPAP on diastolic function in patients with compensated heart failure (CHF)~     are unknown. The investigators hypothesized that acutely CPAP improves diastolic function,~     which is associated with increases exercise tolerance.~      Objective: To evaluate the acute effects of CPAP on functional capacity and diastolic indices~     of patients with CHF. This is a randomized trial including 44 patients with compensated heart~     failure (functional classes II or III, NYHA). Patients will be allocated in CPAP(CPAP with~     10cmH2O) or simulated CPAP (null pressure) after computed randomization, in a 1:1 ratio. All~     subjects shall complete a 6-minute walk test (6MWT) before and after CPAP (30 minutes; 10 cm~     H2O pressure). Doppler-echocardiogram will be performed before and at the end of CPAP.~     Wilcoxon or paired t tests were used to compare results, with significance level at p < 0.05.~   "
189137|NCT01088841|"~     The purpose of this study is to determine the functional significance of sweet taste~     receptors in the secretion of GI satiety peptides by using a specific sweet taste receptor~     antagonist to block sweet taste perception in the gut.~   "
189138|NCT01088828|"~     The purpose of this study is to:~        1. compare structural variations observed in the calf and foot of the clubfoot mouse~          model(pma)with human clubfoot patients antenatally and postnatally;~        2. identify features that might be used in future large scale studies to delineate a~          subtype of human clubfoot associated with lack of response to standard 'Ponseti'~          manipulation treatments.~   "
189139|NCT01088815|"~     This is an open-label, single arm, multi-center, Phase II trial to evaluate the progression~     free survival in patients with metastatic adenocarcinoma of the pancreas treated with a~     hedgehog inhibitor (GDC-0449) in combination with chemotherapy (gemcitabine and~     nab-Paclitaxel).~   "
189140|NCT01088802|"~     This research is being done to try to reduce radiation side effects that happen with the~     standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy~     are standard treatment for people with squamous cell carcinoma of the oropharynx.~      The study will look at giving a slightly smaller dose of radiation (de-intensification) to~     see if regularly expected late toxicities (two years after receiving treatment) can be~     reduced. This study will also try to see if the smaller dose of radiation is equally~     effective at treating the cancer and to see if it improves quality of life. Along with this~     radiation treatment plan some participants in this study will have surgery on their tumor and~     or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy~     will be up to the participant's doctor.~      Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is~     required for this study. Some studies have suggested that HPV-related cancer is biologically~     and clinically different as compared to non-HPV-related cancer. Some studies have found that~     patients with HPV-related oropharynx cancer have a better response to treatment. This test~     will help researchers learn more about HPV-related cancer.~   "
189141|NCT01088789|"~     The purpose of this study is to evaluate the safety and feasibility of long term boost~     vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected~     with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene alone or given in~     combination with either a single intravenous dose or daily metronomic oral doses of~     cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the~     head, neck, tail or the uncinate process of the pancreas.~   "
189142|NCT01088776|"~     Children with Chronic Kidney Disease (CKD) are at very high risk for cardiovascular morbidity~     and mortality. Hyper-lipidemia, a traditional risk factor for Cardiovascular Disease (CVD),~     occurs early in the progression of kidney failure; timely identification and intervention is~     prudent. Currently, there is no known effective therapy for hypertriglyceridemia, the most~     common lipid abnormality. n-3FA, in doses ranging from 2-6 g/day have effectively lowered~     elevated triglyceride (TG) levels by 20-50% in a variety of adult populations; however, their~     use in children with CKD has not been tested in a randomized controlled fashion. This study~     will provide important information on the safety, efficacy and tolerance of n-3FA in lowering~     elevated TG levels in children and adolescents with CKD.~   "
189143|NCT01088763|"~     This phase I/II clinical trial is studying the side effects and best dose of gamma-secretase~     inhibitor RO4929097 and to see how well it works in treating young patients with relapsed or~     refractory solid tumors, CNS tumors, lymphoma, or T-cell leukemia. Gamma-secretase inhibitor~     RO4929097 may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth.~   "
189144|NCT01088750|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and~     prednisolone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Surgery to remove involved lymph nodes may be an~     effective treatment for young patients with nodular lymphocyte-predominant Hodgkin lymphoma.~      PURPOSE: This phase IV trial is continuing to study the side effects of giving surgery alone~     or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared with giving~     cyclophosphamide, vinblastine, and prednisolone alone in treating young patients with stage~     IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma.~   "
189145|NCT01088737|"~     This is a prospective, longitudinal, uncontrolled study with follow-up for 5 years.Patients~     having undergone surgical excision of lentigo maligna (LM) or lentigo maligna melanoma (LMM)~     will be invited to this study. Eligible patients will start treatment with imiquimod 6 weeks~     after the excision, the treatment will last for up to 12 weeks. Inflammatory reactions and~     the occurrence of residual lesions will be documented. The healing effect will be determined~     (initial clearance rate) 20 weeks after start of treatment with imiquimod. All patients who~     were enrolled (=exposed to imiquimod in this study) will be followed up for 5 years or until~     recurrence of the LM or LMM~   "
189151|NCT01088659|"~     This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated~     interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic~     hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180~     micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily).~     Anticipated time on study treatment is 2+ years, target sample size is <50.~   "
189152|NCT01088646|"~     The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic~     capsule placement Capsule Endoscopy Delivery System.~   "
189153|NCT01088633|"~     This study is aiming at evaluating the characteristics of particle emission in subjects with~     different stages of chronic obstructive pulmonary disease (COPD) compared with healthy~     smokers.~   "
189154|NCT01088620|"~     The purpose of this trial is to estimate the therapeutic efficacy of the experimental~     targeted regimen including the EGFR antibody panitumumab (in combination with pemetrexed and~     cisplatin) in relation to the standard combination in patients with a KRAS wild-type stage~     IIIB or IV primary nonsquamous non-small cell lung cancer. It is expected that the~     progression free survival rate at 6 months is improved by the targeted regimen.~   "
189155|NCT01088607|"~     Primary sclerosing cholangitis (PSC), although uncommon, is a devastating and insidiously~     progressive liver disease, resulting from advancing inflammation, fibrosis and obliteration~     of the bile ducts in the liver, leading to cirrhosis and end-stage liver disease. Although~     prognosis in children may be somewhat better than that of adults, approximately one third of~     pediatric patients require transplantation by adulthood. Other than transplantation, there is~     to date no therapy conclusively proven to improve the long-term outcome. Ursodeoxycholic acid~     (UDCA) improves biochemical markers of liver disease, although in high doses does not clearly~     improve the long-term outcome in adults, and in a recent study may have actually worsened~     outcome. Childhood PSC is different from that of adult PSC in many ways, and children may~     derive more short-term, as well as long-term, benefit than adults. This unique multicenter~     study will carefully monitor the effects of withdrawal and restarting UDCA on liver injury~     and inflammation in children with PSC. The preliminary data will help in the design of a more~     definitive larger study to determine if UDCA has a beneficial role in the treatment of PSC in~     children. Funding Source - FDA OOPD~   "
189156|NCT01088594|"~     A single centre, open, randomized, placebo controlled, 3 period cross-over study to evaluate~     the effects of single oral doses of pioglitazone 45mg, rosiglitazone 8mg and placebo on~     urinary sodium excretion in 12 healthy male volunteers~   "
189157|NCT01088581|"~     Several adjuvant therapies have been attempted to reduce uni-centric, and intra- or~     extrahepatic recurrence after curative surgical resection for hepatocellular carcinoma (HCC).~     However, because the efficacy of such adjuvant therapy remains unclear, there is no standard~     postoperative therapy.~      The investigators investigated whether adjuvant hepatic arterial infusional chemotherapy with~     5-fluorouracil (5-FU) and cisplatin reduces the recurrence of HCC after curative resection.~   "
189158|NCT01088568|"~     The objective is to conduct a contralateral prospective clinical study to compare the safety,~     efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens~     TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of~     myopia with astigmatism.~   "
189159|NCT01088555|"~     Sodium thiosulfate may be useful to prevent recurrence of calcium-containing kidney stones.~     It will be studied in people with high amounts of urine calcium.~   "
189160|NCT01088542|"~     The Community Youth Development Study is an experimental test of the Communities That Care~     (CTC) prevention planning system. It has been designed to find out if communities that were~     trained to use the CTC system improved public health by reducing rates of adolescent drug~     use, delinquency, violence, and risky sexual behavior when compared to communities that did~     not use this approach. The primary purpose of the current continuation study is to~     investigate whether CTC has long-term effects on substance use, antisocial behavior, and~     violence, as well as secondary effects on educational attainment, mental health, and sexual~     risk behavior in young adults at ages 21 and 23.~   "
189161|NCT01088529|"~     The goal of this clinical research study is to find out how treatment with abiraterone~     acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH)~     analogue changes the tumor in comparison to treatment with an LHRH analogue alone.~      Objectives:~      Primary Objective:~      To assess the difference in pathologic stage < pT2 between Group A and Group B.~      Secondary Objective:~        -  To assess and compare the changes in levels of androgens (pre, during, and post~          treatment) in the serum, primary tumor microenvironment and bone marrow between Group A~          and Group B.~        -  To assess changes in biomarkers related to androgen signaling and other cancer-related~          pathways between Group A and Group B.~        -  To assess the difference in rate of positive surgical margins between Group A and Group~          B.~        -  To assess the safety profile of abiraterone acetate and low dose prednisone in a~          preoperative setting.~   "
189162|NCT01088516|"~     Therapeutic options to prevent vertical transmission of HIV remain limited. Combination~     antiretroviral therapy in the form of HAART (Highly Active Anti Retroviral Therapy) is~     generally recommended in the developed world, both for its ability to reduce maternal viral~     load, and thus the likelihood of transmission, as well as for its prevention of drug~     resistance mutations, which might otherwise reduce future options for therapy in the mother,~     infant, or both. Exclusive formula-feeding is also recommended in the developed world (where~     clean water sources & adequate hygiene is reliably available) to prevent HIV transmission~     through breastmilk, however, this is not yet a feasible option in many developing world~     settings due to economic, infrastructure, social and infant-health reasons.~      The investigators propose use of a HAART regimen during pregnancy and breastfeeding that is~     based upon the recently released Aluvia tablets (tablet form of LOPINAVIR/RITONAVIR or LOP;~     established capsule form is known as Kaletra) to improve maternal virological control and~     thus mother-to-child-transmission (MTCT).~      Hypothesis: Maternal use of HAART containing Zidovudine, 3TC and Aluvia (Lopinavir/Ritonavir)~     can prevent antepartum, and intrapartum transmission of HIV, as well as allow exclusive and~     then subsequent complementary feeding to be carried out with minimum risk to the mother and~     infant.~        -  Study regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks~          gestational age (GA) and continue through labor and as long as the mother breastfeeds~        -  Peripartum single dose Nevirapine (sdNVP) (Note: Mothers will also be receiving ZDV as~          part of the study regimen) to mother and sdNVP + 5 days postpartum ZDV to the infant~          will be given as per current Zambian practice~        -  Exclusive breastfeeding (EBF) x 6 months then complementary foods to be added, with aim~          for a gradual wean of breastfeeding by infant age of 12-13 months. In case of inability~          to wean by 13 months, however, drug will be continued until the mother has achieved a~          complete wean.~        -  Follow-up period: Mother & child will be followed to an infant age of 24 months, as per~          schedule-of-visits (approx every 3 months)~      Major outcome measure: infant survival and negative dbs (dried blood spot) PCR 3 months post~     weaning.~   "
189163|NCT01088503|"~     The TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and~     Events after Acute Coronary Syndrome (TRANSLATE-ACS) study is a prospective, observational~     longitudinal study to evaluate the real world effectiveness and use of prasugrel and other~     ADP receptor inhibitor therapies among myocardial infarction (MI) participants treated with~     percutaneous coronary intervention (PCI) during the index hospitalization. Participant~     management and treatment decisions are at the discretion of the care team per routine~     clinical practice. Approximately 17,000 participants will be enrolled at approximately 350~     sites in the United States. Follow-up will be conducted through 15 months in approximately~     15,650 participants.~      TRANSLATE-ACS will complement the results of both randomized controlled clinical trials and~     current registries in addressing the real world treatment patterns and clinical outcomes for~     MI participants managed with PCI and initiated on ADP receptor inhibitor therapy. In addition~     to determining the effectiveness of prasugrel in comparison to other ADP receptor inhibitors,~     the study will also determine factors associated with initial ADP receptor inhibitor~     selection and longitudinal patterns of use, evaluate the safety, and describe and compare~     resource use and medical costs associated with ADP receptor inhibitors. Additionally, this~     study will generate a continuum of information from the inpatient to outpatient settings to~     provide a comprehensive picture of participant treatment and outcomes not currently available~     for novel ADP receptor inhibitors.~   "
189164|NCT01088490|"~     Hydrogen sulfide (H2S), better known as a poisonous gas, has emerged as the third gaseous~     transmitter in mammals, next to nitric oxide (NO) and carbon monoxide (CO). Increased~     production and higher serum concentrations were shown in inflammatory diseases, septic shock~     and stroke. The investigators will test the hypothesis that higher serum H2S concentrations~     on admission to intensive care unit (ICU) are linked with higher mortality in patients with~     shock of any reason.~   "
189165|NCT01088477|"~     In 50 breast cancer patients, heavily pretreated with anti-hormonal therapy, the~     investigators will evaluate the use of 16-alpha[18-fluoro]-17beta-estradiol positron emission~     tomography (FES-PET)as predictive biomarker for response to estrogen therapy.~   "
189166|NCT01088464|"~     This study is to establish the safety and pharmacokinetic (PK) profile of IMC-11F8,~     administered either: (1) in a 3-week cycle; or (2) in a 2-week cycle to Japanese participants~     with advanced solid tumors who have not responded to standard therapy or for whom no standard~     therapy is available.~   "
189167|NCT01088451|"~     Postprandial glycemic control is essential for diabetes compensation. Insulin pump therapy~     control blood glucose released in response to both high and low glycemic index carbohydrates~     in a mixed diet using normal, square and dual-wave boluses. The investigators hypothesize a~     mixture of rapid insulin analogue and human insulin has the same effect.~      This pilot prospective cohort study replaces basal-bolus therapy of diabetic subjects by~     combined prandial application of insulin aspart and human insulin. Mixed-meals with high,~     both high and low and low glycemic index carbohydrates are covered by 3:1, 1:1 and 1:3 ratios~     of analogue to human insulin mixture. Subjects are followed by continuous glucose monitor for~     six days (Phase One), changing between the experimental or their standard protocol for~     insulin injection on consecutive days. The outcome was measured by comparing average glycemia~     and areas under the curve of sample meals, which are doughnut, pizza and mixed vegetable~     salad. The next three-to-four week period of therapy was evaluated by glycated hemoglobin~     before and after the intervention (Phase Two).~      Expected outcomes are postprandial and complex improvement of diabetes control, similarly to~     the insulin pump therapy.~   "
189168|NCT01088438|"~     During the project, fourth-year medical students participating in a Medicine sub-internship~     will be randomized to an intervention group or a control group; the intervention group will~     receive additional training in the application of qualitative methodology to elicit and~     incorporate contextual factors in the clinical encounter. All students will participate in an~     SP assessment consisting of four standardized patients (SPs), blinded to trial arm,~     presenting cases with and without important biomedical and contextual factors in a~     counterbalanced factorial design. Performance will be compared between trial arms; the~     investigators hypothesize better performance in the intervention arm. In addition,~     performance will be compared with United States Medical Licensing Exam (USMLE) Step 2~     clinical knowledge scores to determine whether contextualizing ability is independent of~     clinical knowledge, and consistency of performance across individual SP cases will be studied~     to determine the number of cases necessary to achieve sufficient reliability for the~     assessment to be used.~   "
189169|NCT01088425|"~     Great scientific effort has been made to improve practical as well as economical procedures~     of modern assisted reproduction.~      In the last years a shift from the well established method of slow-rate freezing to~     vitrification of 2PN zygotes and embryos could be observed. Like any other method of~     cryopreservation, the outcome of vitrification will be affected by several factors related to~     technique itself, its practical management and patient characteristics.~      The investigators want to investigate the influence of vitrification on the outcome of of 2PN~     oocytes, pregnancy and infant health.~      A Comparison between a cohort of spontaneous conceived children and children of vitrified and~     slow- cooled 2PN oocytes is planned.~   "
189170|NCT01088412|"~     GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the~     safety and effectiveness of Humatrope treatment.~      GeNeSIS is a modular program that includes:~        -  Core study: Evaluating the safety and effectiveness of Humatrope in the observational~          setting~        -  Genetic Analysis Sub-study: Investigating the genetic defects underlying growth hormone~          (GH) deficiency and non-GH-deficient growth disorders~        -  Growth Prediction Sub-study: Working to validate and refine specific models to~          accurately predict growth response to GH~        -  SHOX Deficiency Sub-study: Elucidating the clinical, endocrine and radiological features~          of patients with SHOX deficiency due to loss of, or mutation in the SHOX gene (including~          patients with Turner syndrome)~        -  Neoplasia Sub-study: To characterize the natural history of neoplastic disease,~          especially in relation to recurrence/progression of primary neoplasia or development of~          secondary neoplasia in children with a history of neoplasia~   "
189194|NCT01088100|"~     The purpose of this study is to determine whether a certain clock-gene (HPER3) with the 5/5~     genotype carries a higher risk of post-operative cognitive dysfunction.~   "
195675|NCT01002131|"~     The purpose of this investigation is an exact preoperative 3D-localisation of impacted and~     supernumerary teeth in the maxilla using Cone Beam Computer Tomography~   "
189171|NCT01088399|"~     The Hypopituitary Control and Complications Study HypoCCS is a prospective, open label,~     global, multicentre, observational study on routine clinical care of adults with growth~     hormone deficiency occurring either isolated or in combination with other pituitary hormone~     deficiencies. The objective of this observational study is to evaluate long-term safety and~     health outcomes for adult growth hormone deficient participants with or without somatropin~     replacement therapy. As an observational study, data are collected only as provided at the~     discretion of the attending physician. The participant enrolled meet the criteria of growth~     hormone deficiency in adults as per the Humatrope label in the country where their attending~     physician practices, and this diagnosis is at the discretion of the attending physician. The~     decision to receive somatropin or remain untreated is made by the participant in consultation~     with their attending physician.~      While treatment of adult growth hormone deficient participants with somatropin has been shown~     to be safe and effective in clinical trials of 18 months duration, this observational study~     aims to provide information on health outcome and replacement therapy over longer periods of~     time for a larger number of participants in the context of the overall disease environment.~   "
189172|NCT01088386|"~     The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative~     outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).~   "
189173|NCT01088373|"~     Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine~     and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is~     currently tested in non del 5q MDS patients. Preliminary results have been recently presented~     at ASH meeting (Sekeres et al, 2007).~      Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results~     suggest some efficacy in advanced MDS without del 5q.~      In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q).~      Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to~     escalating doses of lenalidomide (starting at relatively low dose).~      For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to~     continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt~     progression, with the schedule that yielded response.~      In patient still responding after 52 weeks, the drug will continue to be supplied, and follow~     up until death will be continued in all patients.~   "
189174|NCT01088360|"~     The purpose of this study is to compare the incidence rates of targeted infections,~     malignancies and mortality among patients with rheumatoid arthritis who are treated with~     abatacept and those who are treated with other anti-rheumatic medications.~   "
189175|NCT01088347|"~     Chemoradiotherapy has become the standard of care for women with locally advanced cervical~     cancer. The available data support a 30 to 50% reduction in the risk of death from cervical~     cancer for women with locally advanced disease undergoing radiotherapy (RT) and concomitant~     cisplatin-based chemotherapy compared to RT alone. Despite the fact that this is currently~     the best treatment of locally advanced cervical cancer, 5-year overall survival is still only~     52%.~      The fully human, agonist monoclonal antibody mapatumumab binds to the Tumor necrosis~     factor-Related Apoptosis-Inducing Ligand Receptor 1 (TRAIL-R1, DR4) and induces cytotoxicity~     in multiple tumor cell lines in vitro and in vivo. In multiple phase I and phase II studies,~     mapatumumab appeared to be safe both as single agent and in combination with chemotherapy,~     including cisplatin.~      In cervical cancer cell lines, mapatumumab induced apoptosis in 51% of the cells. Mapatumumab~     in combination with irradiation increased apoptosis to 83%.~      In this phase 1b/2 study, the investigators will evaluate the safety, tolerability and~     efficacy of mapatumumab in combination with cisplatin and radiotherapy in patients with~     locally advanced cervical cancer.~   "
189176|NCT01088334|"~     Background~      Patients with an idiopathic venous thromboembolism (IVTE) appear to have a risk of~     approximately 10% for symptomatic malignancy within 3 years after the IVTE. It is not clear~     if extensive screening for malignant disease leads to survival benefit in patients with an~     IVTE.~      The SOMIT study learned that it is feasible to screen patients with an IVTE for malignancy~     and screening by means of a computer tomography (CT) of the chest and abdomen plus a~     mammography in women had the potential to be most cost-effective. The SOMIT study could not~     show a survival benefit due to the design of the study.~      Primary objective: cancer related mortality~      Methods:~      The Trousseau study has been designed as a multicenter, prospective concurrently controlled~     cohort study.~      Inclusion criteria:~        1. Proven first symptomatic deep venous thromboembolic event;~        2. Without: known risk factor for venous thromboembolism.~      Exclusion criteria:~        1. Proven deep venous thromboembolic event in the medical history, age under 40 years;~        2. Patients without signs of malignancy after routine investigations (medical history,~          physical examination, laboratory investigations and chest X-ray) were included.~          Depending on the standard care in the hospital of interest, one group of patients has~          been screened by means of CT-chest and abdomen plus mammography, the other group had no~          additional investigations. Follow-up was aimed to be 3 years in both groups (at 3, 6,~          12, 24 and 36 months after the thromboembolic event).~      Data like mortality rate, morbidity due to screening procedures, additional investigations,~     number of cancer patients detected by the extensive screening, number of cancer patients~     three years after the IVTE, number and kind of investigations performed and information about~     cancer treatment and hospitalization was collected. If this information indicate a survival~     benefit these data enable us to perform a cost-effectiveness analysis.~      Endpoint: Mortality.~      Statistics:~      Based on the prevalence of occult malignancy in VTE patients, the nature and stage of~     malignancies, the expected mortality, the anticipated detection of cancers and the early~     treatment related decrease in mortality we needed, in order to detect a true difference of~     this size with a 80 percent power and a two-tailed certainty of five percent, 750 patients~     for each group. Therefore, a total of 1500 patients is required for this study.~   "
189177|NCT01088321|"~     The purpose of this study is to compare the incidence rates of infection among patients with~     rheumatoid arthritis who are treated with abatacept and those who are treated with other~     anti-rheumatic medications~   "
189178|NCT01088308|"~     This research study is a prospective, single-center, feasibility study designed to assess the~     possibility to detect hemodynamic changes during tachycardia episodes using tissue perfusion.~   "
189179|NCT01088295|"~     This is a research study to see whether fat accumulation either under the skin or in the~     body's organs, for example, the liver, improves in men and women who take a drug called~     telmisartan. The investigators will be looking at how the amount of fat in the body changes~     when HIV-positive persons on effective anti-HIV therapy take telmisartan. The investigators~     will be using a CT scan to make this comparison. Telmisartan is not an HIV medication. It is~     a medication used to treat blood pressure, but has been shown to decrease fat in the organs~     in people both with and without high blood pressure. The study involves 8 visits over a~     period of about 24 weeks.~   "
189195|NCT01088087|"~     Chronic alcohol ingestion is related with leaky gut syndrome. Colostrum is well-studied that~     it has a effect of decreasing the degree of leaky gut syndrome.~      So the investigators are planning to find out whether Colostrum has a effect of decreasing~     the degree of leaky gut syndrome.~   "
189180|NCT01088282|"~     Surgical correction of presbyopia is possible via the implantation of multifocal intraocular~     lenses after removal of the crystalline lens. The cost of these implants is approximately 6~     times higher than the conventional monofocal implants routinely used in all crystalline~     surgery for correction of the resulting ametropia. Spectacles for correcting presbyopia,~     which are necessary after the insertion of monofocal implants, may also have a significant~     cost.~      The proposed trial will involve two randomized groups of patients in need of~     crystalline/cataract surgery, with monofocal or multifocal lens implants (the same type of~     lens in both eyes) leaving them emmetropic for distant vision.~      The objective is to corroborate with blind-evaluation the effectiveness of multifocal lens~     implants in obviating the need for glasses to correct presbyopia, to evaluate the benefits of~     this type of implant, both in global economic terms (adding the cost of the implants to that~     of corrective glasses where necessary) and in terms of the improved quality of life of the~     patients, and to confirm the absence of adverse effects.~      Findings will be subjected to a statistical quantification.~   "
189181|NCT01088269|"~     This is a cross-sectional study including patients with permanent atrial fibrillation.~     Assessment will include:~        -  clinic blood pressure measurements (mercury sphygmomanometer and automated oscillometric~          device)~        -  24-hour ambulatory blood pressure monitoring~        -  determination of various serum markers and cardiac ultrasound.~        -  evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in~          terms of its diagnostic value for the detection of atrial fibrillation compared with the~          reference 24h Holter ECG~   "
189182|NCT01088256|"~     The purpose of the study is to determine the efficacy of etoricoxib on pain patients. The~     investigators assume that patients with neuropathic pain will have greater pain relief then~     patients on placebo.~   "
189183|NCT01088243|"~     The purpose of this study is to understand if a drug called mesalamine helps to control~     inflammation associated with chronic beryllium disease (CBD). We hypothesize that in CBD~     subjects treated with prednisone, mesalamine treatment will enhance the immunosuppressive~     effects of prednisone, and thus reduce the immune response to beryllium.~   "
189184|NCT01088230|"~     The purpose of this study is to see whether treating subjects for wrist rehabilitation~     following stroke with Botox® and robotic therapy is more effective than treatment with~     robotic therapy alone and no Botox®.~   "
189185|NCT01088217|"~     The purpose of this study is to investigate inherited genetic factors that play a role in the~     development of familial pulmonary fibrosis and to identify a group of genes that predispose~     individuals to develop pulmonary fibrosis. Finding the genes that cause pulmonary fibrosis is~     the first step at developing better methods for early diagnosis and improved treatment for~     pulmonary fibrosis. The overall hypothesis is that inherited genetic factors predispose~     individuals to develop pulmonary fibrosis.~   "
189186|NCT01088204|"~     The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted~     distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.~   "
189187|NCT01088191|"~     The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in~     subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction~   "
189188|NCT01088178|"~     The investigators study is a prospective randomized trial of women undergoing the~     levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods:~     immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early~     post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval~     (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in~     preparation for a multicenter, prospective randomized study of long-acting reversible~     contraception in the postpartum period.~   "
189189|NCT01088165|"~     Psoriasis vulgaris is no longer considered as a chronic inflammatory disease restricted to~     the skin. Evidence has accumulated in the past that psoriasis is a chronic inflammatory~     systemic disease. As in rheumatoid arthritis, the chronic inflammatory process plays a~     central role in the pathogenesis of associated comorbidities such as diabetes and~     cardiovascular disease. Since several years the armamentarium of psoriasis treatment has been~     broadened by the availability of TNF alpha blockers. These neutralize systemic TNF alpha~     which not only plays a central role in the pathogenesis of psoriasis but has also been linked~     to inflammatory pathways in diabetes and cardiovascular disease. While a few studies have~     investigated the positive effects of TNF alpha blockers on associated cardiovascular disease~     in rheumatoid arthritis patients, no research data exist on the effects of these therapeutic~     agents in patients with moderate to severe chronic plaque psoriasis.~      The present study aims at determining the effects of adalimumab, a potent and frequently~     prescribed TNF alpha blocker for the treatment of psoriasis, on different diabetic and~     cardiovascular risk factors in patients receiving this treatment as a remedy for moderate to~     severe plaque type psoriasis. The study is designed to explore whether adalimumab is capable~     to prevent or modulate psoriasis-associated comorbidities by blocking systemic inflammation.~     The effects of adalimumab will be compared with those of fumaric acids, which represent an~     established traditional systemic treatment option for moderate to severe psoriasis.~      Study hypothesis:~      Therapy with adalimumab will lead to an improvement of several parameters that reflect the~     risk for diabetes and cardiovascular disease in patients with chronic plaque psoriasis due to~     chronic inflammation. Endothelial dysfunction, as assessed by ultrasound flow mediated~     dilatation, will serve as primary outcome measure. Other risk factors such as blood lipids,~     hsCRP, IL-6, endothelial adhesion molecules, parameters of glucose metabolism and carotid~     intima-media thickness will be secondary outcomes.~      Aim:~      If adalimumab and/or fumaric acids will show a significant impact on the above mentioned~     parameters, these findings would offer a new perspective for the long term management of~     psoriatic patients and their comorbidities.~      Study design: Randomized, prospective, controlled, parallel group study~      Study population: 66 patients~   "
189190|NCT01088152|"~     Swedish celiac disease women living on a gluten-free diet for years report poorer subjective~     health and more bowel complaints than Swedish women of same age in general population.~      The investigators hypothesis is that the women participating in an education programme based~     on problem based learning will show higher degree of perceived health than the women~     receiving usual care.~   "
189191|NCT01088139|"~     This is a randomized controlled, observer blinded trial to study the beneficial effect of~     nutritional supplementation in elderly Hong Kong patients after hip fracture surgery during~     rehabilitation and at 4 weeks follow up. The control group will receive Calcium and Vitamin D~     supplementation whereas the intervention group will receive a moderately high dose protein~     nutritional supplementation in addition to Vitamin D and Calcium. Both groups undergo the~     same rehabilitation program and dietary counseling before discharge. They are followed up 4~     weeks after discharge or completion of supplementation. The outcome parameters are~     nutritional parameters and rehabilitation outcomes.~   "
189192|NCT01088126|"~     The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not~     established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial~     tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the~     clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.~   "
189196|NCT01088074|"~     The aim of the study is to compare incision closure techniques for total knee replacement~     using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort~     to identify the best approach with respect to time efficiency, cost, durability, dehiscence,~     microbial resistance and cosmesis.~      The hypothesis is that the combined suture/adhesive approach (sutures for capsule and~     subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple~     approach will be significantly faster and of comparable durability as the conventional~     exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers).~     This is a prospective, randomized, controlled, single site, unblinded (open label) study.~   "
189197|NCT01088061|"~     The purpose of the study was to investigate adipose expression and plasma levels of different~     adipocytokine, which may play a role in the pathophysiology of PCOS. The investigators~     investigated lean and obese women with and without PCOS.~   "
189198|NCT01088048|"~     This study will evaluate the safety and clinical activity of idelalisib in combination with~     an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, an mTOR inhibitor, a~     protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants~     with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma~     (MCL), or chronic lymphocytic leukemia (CLL).~   "
189199|NCT01088035|"~     This is a phase II study evaluating the feasibility of concurrent carboplatin given with~     focal radiation therapy in children age 12 months to < 21 years with newly diagnosed~     localized ependymoma who have no or minimal residual disease post-operatively (< 0.5 cm). The~     hypothesis is that utilizing carboplatin as a radiosensitizer is feasible and tolerable and~     may improve event-free survival (EFS) and minimize local recurrences as compared to historic~     controls. Following a neurosurgical resection and staging, patients who meet the eligibility~     criteria will receive standard fractionated radiation therapy at doses of 54 to 59.4 Gy to~     the primary site depending upon age. All patients will receive 35 mg/m²/day of carboplatin~     prior to each fraction of radiotherapy. Although significant neutropenia is not anticipated,~     G-CSF will be administered per study guidelines during radiation if neutropenia occurs. All~     patients will be followed for toxicity, response (resolution of residual disease) and~     event-free survival (EFS). Patients' tumor sample, blood and cerebro-spinal fluid (CSF) will~     also be prospectively evaluated to quantify the level of Survivin, a known inhibitor of~     apoptosis, via immunohistochemistry, Western Blot Analysis (in tumor tissue) and ELISA (in~     blood and CSF). The feasibility of obtaining these levels prospectively and in real time will~     be evaluated.~   "
189200|NCT01088022|"~     Title of the study Aprepitant for prevention of acute and delayed nausea and vomiting: a~     phase III, double-blind, randomized, placebo-controlled trial in patients receiving a~     high-emetogenic dose of cyclophosphamide for peripheral blood stem cells harvesting~      Objective(s) Primary objective: to confirm and extend the investigators preliminary data on~     the efficacy and safety of combined aprepitant, palonosetron and dexamethasone in preventing~     CINV after high emetic therapy with cyclophosphamide 3 g/m2 compared with the palonosetron~     and dexamethasone regimen.~      Secondary objective: to monitor peripheral blood stem cell harvest. Methodology Single~     centre, randomized, double-blind, placebo-controlled phase III trial Endpoints Primary~     endpoint: the complete response (CR) rate defined as the number of patients with no emetic~     episodes and no rescue medication in the first 120 hours post-chemotherapy.~      Secondary endpoints:~        -  CR rates for acute (0-24 h) and delayed (24-120 h) phases;~        -  complete control rate (CC) defined as no emetic episode, no rescue medication use and no~          more than mild nausea;~        -  number of emetic episodes;~        -  severity of nausea;~        -  impact of CINV on daily life as measured by the Functional Living Index-Emesis (FLIE)~          (total score > 108 = no impact);~        -  peripheral blood stem cell harvest;~        -  tolerability (adverse events, drug-related adverse events, serious adverse events;~          discontinuation of treatment due to an adverse event). Adverse events will be classified~          using NCI Common Toxicity Criteria.~      Number of patients A total of 120 patients will be enrolled Inclusion criteria - Male or~     female patients ≥ 18 years of age~        -  Patient is able to understand study procedure and agrees to participate in the study by~          giving written informed consent.~        -  Patient is scheduled to receive a highly emetogenic cyclophosphamide IV chemotherapy (3~          g/m2) for autologous PBSC harvesting~        -  Karnofsky score ≥60~        -  Normal laboratory values~        -  Normal ECG~        -  HBV-, HCV- and HIV- negative~        -  Negative urine pregnancy test for women of childbearing age Treatment Eligible patients~          will be randomized to receive oral doses of Aprepitant (125 mg day 1, 80 mg days 2 and~          3), dexamethasone (8 mg/day for 3 days) and a single intravenous dose of palonosetron~          (0.25 mg on day 1) versus placebo plus dexamethasone (8 mg/day for 3 days) and a single~          intravenous dose of palonosetron (0.25 mg on day 1) Duration of study 3 years Criteria~          for evaluation Efficacy and safety data will be obtained using the patient's daily diary~          (days 1 through 5) reporting the number of episodes of retching and vomiting, severity~          of nausea (using a categorical scale of none, mild, moderate or severe), and overall~          quality of life. The FLIE 8 questionnaire will be completed on days 1 (before starting~          chemotherapy) and 6 (after chemotherapy). All side effects attributed to this~          combination therapy will be recorded daily.~      Safety parameters: medical history, clinical examination and weight, vital signs, laboratory~     tests (hematology, chemistry, urine analysis and urine pregnancy test for women of~     childbearing age).~      Statistical aspects Sample size was defined assuming the cumulative incidence rate of the~     primary endpoint to be 68% in the treatment group and 41% in the control group. With balanced~     allocation in the two groups, considering a two sided test with α=0.05 and ß=0.20 a total of~     110 patients is needed. As few withdrawals and drop-outs are expected a total of 120 patients~     will be enrolled.~      Intention to treat approach will be used for all efficacy analysis. The primary endpoint will~     be analysed by binomial logistic models. The dependent variable will be vomiting yes/no~     during the first 120 hours after chemotherapy. Anti-emetic treatment, gender and age will~     enter as explicative variables.~      Dichotomous secondary endpoints will also be analysed by binomial logistic models.~     Multinomial logistic models will analyze the severity of nausea, stratified in 4 classes.~      Generalized Linear Models will investigate quantitative variables such as number of retching~     or vomiting episodes and peripheral blood stem cell harvest.~      In all tests, p value <0.05 will be considered statistically significant. No interim analyses~     are planned.~   "
189201|NCT01088009|"~     The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy,~     and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.~   "
189202|NCT01087996|"~     The technique of transplanting progenitor cells into a region of damaged myocardium, termed~     cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or~     repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily~     available, easy to culture to ensure adequate quantities for transplantation, and able to~     survive in host myocardium; often a hostile environment of limited blood supply and~     immunorejection. Whether effective cellular regenerative strategies require that administered~     cells differentiate into adult cardiomyocytes and couple electromechanically with the~     surrounding myocardium is increasingly controversial, and recent evidence suggests that this~     may not be required for effective cardiac repair. Most importantly, transplantation of graft~     cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a~     number of candidate cells have been transplanted in experimental models, including fetal and~     neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile~     grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac~     precursors residing within the heart itself. There has been substantial clinical development~     in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both~     post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and~     heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also~     been studied clinically.~      Currently, bone marrow or bone marrow-derived cells represent highly promising modality for~     cardiac repair. The totality of evidence from trials investigating autologous whole bone~     marrow infusions into patients following myocardial infarction supports the safety of this~     approach. In terms of efficacy, increases in ejection fraction are reported in the majority~     of the trials.~      Chronic ischemic left ventricular dysfunction resulting from heart disease is a common and~     problematic condition; definitive therapy in the form of heart transplantation is available~     to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart~     failure has been studied less than for acute MI, but represents a potentially important~     alternative for this disease.~   "
189203|NCT01087983|"~     The goal of this clinical research study is to find the highest tolerable dose of 2 different~     combinations of drugs that can be given to patients with advanced cancer. The first~     combination of drugs is Tykerb (lapatinib) and Rapamune (sirolimus), and the second~     combination is lapatinib and Glucophage (metformin). The safety of these drug combinations~     will also be studied.~   "
189204|NCT01087970|"~     The purpose of this study is to look for an improvement in progression free survival with the~     combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with~     recurrent or metastatic squamous cell carcinoma of the head and neck.~   "
189205|NCT01087957|"~     To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO)~     for patients with foot drop due to stroke, and to assess the functional improvement of~     ambulation and improved activities of daily living.~   "
189206|NCT01087944|"~     This randomized, cross-over, open label study will compare the tolerability and handling of~     application of peginterferon alfa-2a [Pegasys] by autoinjector versus pre-filled syringe in~     patients with chronic hepatitis C, either on treatment with peginterferon alfa-2a for at~     least 12 weeks or treatment-naïve for peginterferon alfa-2a. Patients will be randomized to~     self-injection of 180mcg peginterferon alfa-2a once a week using either an autoinjector or a~     prefilled syringe for 3 weeks, then switch to use the other method of injection for another 3~     weeks. Anticipated time on study treatment is 6 weeks. Target sample size is <100 patients.~   "
189227|NCT01087671|"~     The purpose of this study is to investigate if changes in ocular signs and symptoms occur in~     patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005%~     (Xalatan) to preservative free Tafluprost eye drops.~   "
189238|NCT01087515|"~     The aim of this study is to investigate the immunomodulatory potential of Isolated~     Plasmacytoide Dendritic Cells (pDCs) and Regulatory T-cells (TREGs) isolated with clinical~     grade magnetic bead isolations techniques (MACS®) on the antigen presenting cell-induced~     proliferation of lymphocytes after allergen uptake in an in vitro cell culture system.~   "
189635|NCT01082328|"~     The primary objective of the study is to evaluate the proportion of responders (that is,~     greater than or equal to [>=] 30 percent reduction from Baseline in blood phenylalanine [Phe]~     level) to treatment with Kuvan® (sapropterin dihydrochloride) 20 milligram per kilogram per~     day (mg/kg/day) for 28 days.~   "
189207|NCT01087931|"~     The use of iliac crest bone graft (ICBG) remains the gold-standard in spinal reconstructive~     surgery for achieving fusion. Major complications from the harvesting of ICBG are rare, but~     chronic pain has been reported in 10-39%. Catheters implanted at the time of surgery have~     been used to provide local anesthetic at the harvest site for 24-48 hours after surgery. This~     has been shown to decrease chronic pain at 4 years post-operatively. A single application of~     local anesthetic at surgery has been shown to decrease pain at the harvest site for up to 5~     days. No study has demonstrated a benefit to using a single application of local anesthetic~     at the ICBG site beyond 5 days. In current clinical practice, the use of a local anesthetic~     at the ICBG site is determined according to surgeon preference. The purpose of this study is~     to determine if a single application of bupivacaine at the ICBG site, as currently done in~     some cases, provides any pain relief beyond 5 days such as that demonstrated with longer~     infusions of local anesthetics.~   "
189208|NCT01087918|"~     The purpose of this pilot study is to investigate whether gait specific robotic supported~     bodyweight supported treadmill training and lower extremity strength training have similar~     beneficial effects on walking function and other outcomes.~   "
189209|NCT01087905|"~     Research shows that smoking cessation is the most significant preventable health behavior~     change that a person can make to lower cancer risk. In addition, telephone quitlines are an~     effective, science-based smoking cessation treatment that is universally accessible to~     smokers in the U.S. However, little research has explored promising approaches that could~     increase quitline use, improve quit rates, and inform resource allocation for quitline~     services. The proposed study will test three promising enhancements to the standard quitline~     treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication.~     These enhancements are: 1) combination nicotine replacement therapy as recommended by the~     United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and~     Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling~     addition - cognitive medication adherence counseling - to optimize adherence to cessation~     medication. In addition, the cost-effectiveness of each intervention will be calculated. The~     findings of the proposed research have broad potential application and relevance to state~     quitlines, quitline service providers, and other purchasers of quitline services such as~     employers and insurers. Additionally, the study findings can potentially inform other~     telephone health behavior counseling programs.~   "
189210|NCT01087892|"~     Antibiotics are currently required to treat patients in hospital when they have an infection,~     but these antibiotics can cause side effects such as diarrhoea and in some patients a serious~     form of gut infection with an organism called Clostridium difficile. This organism can~     produce toxins in the gut causing a severe form of diarrhoea associated with a lot of ill~     health, and in some circumstances can be fatal. Some studies have shown that yogurts' or~     Probiotics' (special drinks with a defined concentration of useful bacteria) taken by~     patients can have a beneficial effect in reducing the diarrhoea associated with antibiotics~     use. The aim of the present study is to find out whether the use of one of these Probiotics~     in hospitalised patients taking antibiotics will result in less diarrhoea, less Clostridium~     difficile infection, as well as cost saving. The study will also analyze the effects of~     probiotics on quality of life and length of hospital stay.~   "
189211|NCT01087879|"~     The impact of different administration routes of hormonal contraceptives on androgen~     secretion, glucose metabolism and inflammation. A prospective randomized trial.~      The investigators assume, that transdermal or transvaginal hormonal contraception would have~     less effects on androgen levels, glucose metabolism and inflammatory markers than oral~     contraceptives.~   "
189212|NCT01087866|"~     The purpose of this study is to determine if metformin therapy prevents fetal macrosomy in~     gestational diabetes mellitus to the same extent as insulin therapy.~   "
189213|NCT01087853|"~     Patients often require fluid replacement during and after an operation. This is usually given~     through veins in the arm using an intravenous cannula and doctors have traditionally used~     fluid containing sodium chloride (saline). However accumulating evidence suggests that large~     infusions of saline are associated with adverse physiological effects including acidification~     of the blood and a rise in potassium and chloride levels. Studies in animals have shown that~     high levels of chloride in the blood and excess saline can cause blood vessels in the kidney~     to constrict leading possibly to a decrease in kidney function. Improvement in acid-base~     balance and kidney function may be observed with balanced solutions containing constituents~     that are more closely matched to the body's own fluid composition. However, little is known~     about the physiological effects of these solutions as they have only recently been developed.~      Magnetic resonance imaging (MRI) is a radiological modality which can now assess blood flow~     and supply of the kidney noninvasively without the need for the injection of radiological~     dyes known as contrast agents. This is now of major importance due to the possible adverse~     effects of MRI contrast agents leading to Nephrogenic Systemic Fibrosis (NSF), a progressive~     disease which has been observed in some kidney patients after receiving 'gadolinium based'~     contrast agents. This has therefore led to increased interest and demand for noncontrast~     based imaging methods. In this study we aim to compare the effects of balanced versus~     unbalanced fluid infusions in healthy human volunteers:~      We will aim to measure:~        1. Blood biochemical composition and acidity~        2. Kidney function and supply as measured by dynamic MRI~   "
189228|NCT01087658|"~     Primary Objective:~      To assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade~     2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National~     Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) scale taking into~     account the time from start of oxaliplatin at which the first event occurred.~      Secondary Objective:~      To determine cumulative dose of oxaliplatin and time when the first occurrence of grade 2, 3~     or 4 PSN.~      To determine the incidence of dose-reductions, dose-delays and discontinuations of~     oxaliplatin due to PSN grade 3 or 4.~      To assess effects of glutamine when added to calcium-magnesium on patients-reported outcomes~     using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12~     items questionnaire (FACT/GOG NTX-12) subscale.~      To evaluate the incidence of diarrhea. To determine Progression Free Survival (PFS) in~     metastatic patients.~   "
189229|NCT01087645|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy~     male subjects.~   "
189214|NCT01087840|"~     The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV~     in order to try and prevent an exposure from becoming an infection is common. This is called~     nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is related~     to intrinsic qualities of the drugs used which includes at which point in the life cycle of~     the HIV virus the drugs work, how strong the drugs are against HIV, and how well tolerated~     the drugs are i.e. what side effects they produce. Many people skip doses during their~     treatment or abandon their treatment because of side effects. The anti-HIV drug raltegravir~     works early in the life cycle of the virus i.e. before it integrates with human DNA, is~     potent against HIV and causes few side effects. These qualities make it an obvious choice for~     use as a NPEP treatment. In this study 100 HIV negative men will receive raltegravir along~     with another HIV drug called truvada (commonly used in NPEP) for 28 days after a possible~     sexual exposure to HIV. They will be monitored closely for adverse events, side effects and~     for their ability to take the medicine each day for the whole 28 days. The hypothesis in this~     study states that raltegravir use in NPEP will be safe, well tolerated and result in a high~     treatment completion rate.~   "
189215|NCT01087827|"~     The first purpose of this study is to see how blood pressures taken at different sites,~     specifically the forearm, upper arm and heart vessels, are different. The second purpose is~     to see if body structures such as vessel size and depth, size of the arm, and amount of~     tissue in the arm influence differences in blood pressures taken at these sites. The third~     purpose is to develop a mathematical model of the waves generated by the arm arteries~     (brachial and radial) to predict differences in forearm and upper arm blood pressures. The~     results of the study may be used to design more accurate non-invasive blood pressure monitors~     for the forearm site.~   "
189216|NCT01087814|"~     We are studying if putting a gel capsule over a standard HIV drug changes the ability of the~     body to absorb the drug. This is important because we want to be able to study new HIV drugs~     against the most common drugs used today and the most common is Sustiva, which is also called~     efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is~     absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will~     draw blood to see how much is absorbed.~   "
189217|NCT01087801|"~     The following are the study hypothesis:~        -  Secretin administration compared to placebo will result in a statistically significantly~          greater percentage of collected fluid samples being predominantly of exocrine pancreas~          origin when samples are duodenal aspirates.~        -  Secretin administration compared to placebo will result in a statistically significantly~          greater percentage of collected fluid samples meeting the minimum specifications for use~          in the indicated laboratory test of DNA mutational analysis.~   "
189218|NCT01087788|"~     Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to~     evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset~     active and progressive Psoriatic Arthritis (PsA).~   "
189219|NCT01087775|"~     The investigators hypothesis are as follows:~      H1a: OEF/OIF veterans with PTSD who perform cognitive training (CT) will demonstrate greater~     objective improvements on standard (untrained) neurocognitive measures, with the largest~     gains in verbal memory, learning and sustained attention.~      H1b: Objective cognitive improvements in CT participants will be sustained at three months~     post-intervention, suggesting persistence of neuroplasticity-based cognitive training~     benefits.~      H2a: OEF/OIF veterans with PTSD who perform CT will report greater improvements in cognitive~     function.~      H2b: OEF/OIF veterans with PTSD who perform CT will demonstrate improved social and~     occupational functioning and quality of life.~      H2c: OEF/OIF veterans with PTSD who perform CT will demonstrate greater improvements in~     community reintegration.~   "
189220|NCT01087762|"~     The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to~     evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects~     with active axial Spondyloarthritis (axial SpA).~   "
189221|NCT01087749|"~     The purpose of this study is to find out how chemicals in the blood of patients with chronic~     kidney disease affect how medications are removed from the body. The patient will take one~     dose of three different drugs, one on each week, for a total of three single doses. The~     investigators want to find out if these three different medications are affected in different~     ways by the chemicals in the blood of patients with kidney disease.~   "
189222|NCT01087736|"~     The proposed project aims to:~        1. Obtain a preliminary assessment of the efficacy of topiramate treatment in reducing~          alcohol use in veterans with Post Traumatic Stress Disorder (PTSD) and alcohol~          dependence;~        2. Obtain preliminary assessments of safety/tolerability of topiramate in these patients;~        3. Assess the feasibility of recruitment and retention for topiramate treatment in this~          comorbid population; and 4) to inform the design of a planned subsequent larger~          controlled trial of topiramate.~      PRIMARY HYPOTHESIS: Topiramate treatment combined with Medical Management alcohol counseling~     will be associated with a significant decrease in percent drinking days from baseline to end~     of treatment.~      SECONDARY HYPOTHESIS: There will be significantly less percent drinking days in the~     topiramate treatment group compared to the placebo group.~   "
189223|NCT01087723|"~     To show that the early administration of bivalirudin improves 30 day outcomes when compared~     to the current standard of care in participants with ST segment elevation acute coronary~     syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI)~     management strategy, presenting either via ambulance or to centers where PCI is not~     performed.~   "
189224|NCT01087710|"~     To determine the effect of medical food on reducing asthma symptoms in asthmatic children.~   "
189225|NCT01087697|"~     The purpose of this study is to see if the Neo-Urinary Conduit(NUC), which is made in the~     laboratory from a combination of a patient's own cells and other materials can be used to~     form a conduit to safety allow urine flow from the kidneys to outside the body after radical~     cystectomy in patients with bladder cancer.~   "
189226|NCT01087684|"~     Laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either~     argon (ALT) or selective Yag (SLT) lasers. The effectiveness of each has not been studied in~     patients under 60 years, which is younger than average for the procedure. The study~     hypothesis is that there will be no difference between the two laser types.~   "
189230|NCT01087632|"~     Metabolic syndrome is a highly prevalent condition characterized by visceral obesity,~     abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events.~     Such findings appear to be associated with a decrease in insulin sensitivity. Management of~     metabolic syndrome is currently aimed at treating individual components of the disease~     without addressing this underlying pathophysiologic mechanism; this translates into multidrug~     regimens, high costs and patient compliance issues.~      Armolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin~     K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to~     be effective at reducing blood cholesterol and triglycerides, and at improving endothelial~     function; subgroup analyses also suggested a benefit on indices of insulin resistance.~      Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on~     the diagnostic parameters of metabolic syndrome.~      60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial;~     active treatment will consist of Armolipid Plus (1 tbl qd).~      Primary end point will be the reduction of the insulin/glucose ratio, both after overnight~     fast (HOMA index) and after an oral glucose tolerance test (OGTT).~   "
189231|NCT01087619|"~     General consensus and contemporary guidelines, recommend surgery for primary~     hyperparathyroidism (pHPT)for all patients below the age of 50, for patients with pronounced~     hypercalcemia and for patients with organ complications to the disease (osteoporosis and~     decreased renal function).~      The purpose of this study is to determine if surgery for pHPT, is appropriate for patients~     with moderate to mild hypercalcemia older than 65 years of age.~      The hypothesis of the study is that surgery for pHPT in patients older than 65 years of age,~     and with mild hypercalcemia, will increase bone density and hence decrease future risk for~     fragility fractures compared to patients with follow-up only.~   "
189232|NCT01087593|"~     In order to evaluate the potential effects of estrogen treatment in postmenopausal women with~     fibromyalgia, the investigators used quantitative sensory tests before and after eight weeks~     of estrogen treatment as compared with placebo treatment.~   "
189233|NCT01087580|"~     The main purpose of this study is to find out whether adding radiation therapy to the~     standard treatment of chemotherapy for prostate cancer is tolerated well and is more~     effective than the standard treatment of chemotherapy alone~   "
189234|NCT01087567|"~     T2DM has become an American Epidemic. Currently 8% of the US population has diabetes and~     rates may be as high as 33% by the year 2050 (1). Although there are many treatment options~     for people with T2DM, none have been proven in humans to prevent the defects in insulin~     secretion (2) and insulin action (3) and beta cell dysfunction (4) that result with very high~     glucose levels and typically worsen as the disease progresses. Any treatment that could delay~     the progression of pancreatic beta cell failure (as measured by the need for rescue therapy~     with oral agents) would be a significant advancement in diabetes treatment.~      Insulin therapy is appropriate at any point in T2DM disease progression, but it is commonly~     only used as a rescue therapy after failure of oral therapies. A number of outpatient insulin~     titration protocols have been shown to be safe and effective and speed patient's ability to~     gain glucose control (5-8). Recent studies have shown that initiation of insulin at onset of~     T2DM is beneficial at achieving early and long-term glucose control (6-9). However these~     protocols have used intravenous human insulin in the in-patient setting, continuous~     subcutaneous insulin by insulin pump or older human insulins in the out-patient setting. Many~     of these protocols are unlikely to be utilized in routine patient care. To date, no insulin~     first studies have been published with analog insulins in an outpatient basal-bolus regimen~     with patient driven titration.~   "
189235|NCT01087554|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination vorinostat given in combination with either sirolimus, everolimus or temsirolimus~     that can be given to patients with advanced cancer. The safety of this drug combination will~     also be studied.~      The Study Drugs:~      Vorinostat is designed to prevent or slow down the growth of cancer cells by blocking~     proteins.~      Everolimus is designed to stop cells from dividing. This may stop or slow the growth or~     spread of cancer cells.~      Temsirolimus is designed to block a protein called mTOR (a protein that is thought to cause~     cancer cells to grow) inside the cancer cell. This may interfere with the growth or spread of~     cancer cells or possibly kill them.~      Sirolimus is designed to block a protein called mTOR inside the cancer cell. This may~     interfere with the growth or spread of cancer cells or possibly kill the cancer cells.~      This is an investigational study. Sirolimus is FDA approved and commercially available as an~     anti-rejection drug for kidney transplant recipients. Everolimus is FDA-approved and~     commercially available for the treatment of pancreatic neuroendocrine tumor, subependymal~     giant cell astrocytoma, and renal cell carcinoma. Temsirolimus is FDA approved and~     commercially available for the treatment of renal cell carcinoma. Vorinostat is FDA approved~     and commercially available for the treatment of cutaneous T-cell lymphoma. The combination of~     these drugs is investigational.~      Up to 249 patients will take part in this study. All will be enrolled at MD Anderson.~   "
189236|NCT01087541|"~     The safety in the diabetic patient refer so much to the accuracy of the treatment and to the~     handling of the diabetic in security topics. Therefore, is not only an economic question, but~     a more global concept that means to receive an accurate sanitary attention in line with the~     available evidences nowadays.~      OBJECTIVE: To analyse if a brief intervention educative on the primary care professionals is~     followed of an improvement in the safety of the diabetic patients.~      METHODS: Cluster Clinical trial, completely in primary care, on 10 basic health areas (BHA)~     with a random distribution of the educative intervention to realize on the sanitary~     professionals (5 intervention/5 control). The intervention is an educative system on adults,~     brief (6 hours) but with periodic reminders. To improve his skills and attitudes for the~     diabetics. The group control follows his usual clinical practice on the diabetics.~      The participation was voluntary. The centres have been matched, being comparable in~     population and other characteristics, except the specific intervention; ranging between the~     6-8% the prevalence observed of type 2 diabetes (T2D) in all the cases. Finally, we selected~     only between 45 until 75 years old as operative age group of the 45 until the 75 years like~     operative aim.~      Inclusion criteria: T2D or T1D with age comprised between 45 and 75 years; recorded in the~     informatic software for primary care.~      Exclusion criteria: serious or terminal illness or patients controlled exclusively by~     specialists.~   "
189239|NCT01087502|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or~     previously treated type 2 diabetic patients with moderate to severe renal impairment and~     insufficient glycaemic control. In addition safety in this patient population with longer~     term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).~   "
189240|NCT01087489|"~     Patient comfort during and after eye injections will be compared after two numbing~     (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4%~     lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.~   "
189241|NCT01087476|"~     Background. Mucositis is a complication of chemotherapy with no effective treatment. Aim.To~     evaluate the efficacy of sub-microbial doses of doxycycline hyclate in preventing the~     development of oral mucositis in patients with acute leukemia (AL) treated with induction~     chemotherapy.~      Hypothesis. Doxycycline hyclate administration in sub-microbial dosage will reduce the~     incidence of oral mucositis in patients with AL who receive induction chemotherapy.~      Methods. Double-blind, randomized, placebo-controlled clinical trial. At the Cancer National~     Institute (INCan), adult patients (> 18 years of age) with acute leukemia of recent~     diagnosis, scheduled to receive induction chemotherapy will be enrolled in the study. Written~     informed consent from the patients will be obtained preceding inclusion in the study.~      At baseline and 3-times per week, during 21-days, patients will have an oral examination~     performed using the Oral Mucositis Assessment Scale (OMAS), oral pain, difficulty to swallow,~     and salivary flow measurements will be recorded.~      A sample size of 164 subjects has been calculated, 74 subjects in each arm of the study. The~     primary end point of this study to evaluate the efficacy will be the proportion of patients~     treated with doxycycline or placebo without oral lesions associated with OM, during the 21~     days of follow-up. Efficacy will be evaluated if the proportion of complete response (CR) is~     significantly higher than the proportion of events in the placebo group. Additional secondary~     endpoints will be the partial resolution of the oral lesions, the incidence of infections and~     the mortality in the study groups during the 21 days of follow-up. Results will be analyzed~     by using Chi-squared test and Wilcoxon-Mann-Whitney rank sum test.~   "
189242|NCT01087463|"~     The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the~     Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.~   "
189243|NCT01087450|"~     The objective of this study is to determine if observations the investigators made in an~     animal model of sepsis can be translated to clinical practice. Specifically, the~     investigators will use the noninvasive Orthogonal Polarization Spectral (OPS) microscope and~     venous oxygen saturation to test the hypothesis that recombinant human erythropoietin(rHuEPO)~     will acutely improve the microcircualtion in septic patients in the ICU.~   "
189244|NCT01087437|"~     BACKGROUND: Distraction osteogenesis, the gradual lengthening of bones, is performed in order~     to equalize leg length discrepancy and correct skeletal deformities or to achieve greater~     height in short stature people. The femur and tibia are the bones most frequently lengthened.~     The surgery is currently performed at Hadassah Medical Center routinely by the pediatric~     orthopedic team utilizing a variety of external fixation devices.~      The procedure involves application of an external fixation device to the bone, creation of an~     osteotomy and gradual, controlled distraction of the bone fragments On the last week of the~     distraction phase and every month thereafter, patients will be provided with a monthly supply~     of gastrolith calcium in a sealed container (65 capsules of 500 mg each, provided by~     Amorphical). Starting on the first day of the last week of the distraction phase, during the~     entire consolidation phase until the external fixator is removed; adults will orally consume~     two (2) 500 mg capsules a day (total of 1 gr of gastrolith calcium). Children will be given~     25 mg calcium per kg body weight up to the daily adult dose of 1000mg .~   "
189245|NCT01087424|"~     The purpose of the study is to evaluate efficacy and safety of R-miniCHOP for elderly~     patients with diffuse large B-Cell lymphoma (DLBC) Lymphoma aged over 80 years by measuring~     the overall survival.~   "
189246|NCT01087411|"~     The purpose of this study is to study whether a targeted intervention can increase physical~     activity in inactive 8-yr old children and how it affects secondary measures such as~     metabolic- and cardiovascular risk factors and markers, self-reported quality of life, BMI,~     body composition and aerobic work-capacity.~   "
189247|NCT01087398|"~     The purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic~     cells using chemotherapy regimen without total-body irradiation in children undergoing a~     hematopoietic stem cell transplant for Malignant infantile osteopetrosis. The blood stem~     cells will be derived from either related donor or unrelated umbilical cord blood or~     haploidentical donor.~   "
189248|NCT01087385|"~     Study hypothesis: elevated Troponin T is a marker of increased mortality in patients with~     peripheral arterial occlusive disease (PAOD).~   "
189249|NCT01087372|"~     This is a prospective observational study to examine the levels of glucoregulatory hormones,~     with special focus on incretins levels, in critically ill patients with stress hyperglycemia.~   "
189250|NCT01087359|"~     This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40~     year. The design is based on 6 days:~        -  day 1: On day time administration of LPS.~        -  day 2: On night time administration of LPS.~        -  day 3: On day time administration of LPS + Placebo.~        -  day 4: On day time administration of LPS + melatonin.~        -  day 5: On night time administration of LPS + placebo.~        -  day 6: On night time administration og LPS + melatonin.~      Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin~     compared to placebo on the endotoxaemia.~   "
189285|NCT01086904|"~     The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted~     Influenza A (H1N1) vaccine in renal transplant recipients.~   "
189286|NCT01086891|"~     Some oxygen conserving devices have been developed to diminish oxygen expense. These devices~     offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients.~   "
189287|NCT01086878|"~     The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia~     or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral~     therapy.~   "
189251|NCT01087346|"~     Summary:~        -  A few studies have explored the effects of providing parents with health information~          about their children. However, more information is needed about the relationship between~          awareness of health information and changes in behavior. This study will investigate the~          impact of health information on choices that parents make about food for their children.~        -  Mothers and fathers with a biological child between the ages of 3-7 years old may be~          eligible for this study. Participants are recruited from the Washington, DC metropolitan~          area.~        -  In this study, before visiting the research center, participants will answer online~          questionnaires about their children's health and eating habits and their own health and~          eating habits.~        -  At the research center, participants will use a virtual reality model of a buffet to~          make food choices for their children. Participants will be introduced to the~          computer-based virtual buffet scenario as a training session to prepare for using the~          buffet during the experimental context. While in the virtual environment, participants~          wear a virtual reality helmet that allows them to see the virtual buffet scenario.~        -  After the training session, participants will watch an interactive computer presentation~          about a health topic.~        -  Participants will then visit the virtual buffet scenario again for the formal session,~          and will choose a virtual lunch meal for their child as before.~        -  At the end of their visit, participants will complete post-test questionnaires about~          their experiences during the experiment and other research-related information.~        -  Participants will be asked to complete a follow-up questionnaire online a week after~          their visit~        -  The total time for the study visit is approximately 90 minutes. The participants~          children will not be asked to take part in the study.~      Eligibility:~        -  Men and Women at least 18 years of age who have a biological child between the ages of 3~          and 7 who has no major diet-related health conditions, developmental delays, or~          disabilities. You may not take part in the study if you have a history of seizures~          and/or are pregnant.~   "
189252|NCT01087333|"~     Background:~      - Researchers who are studying hairy cell leukemia, and how the disease compares with other~     disorders, are interested in obtaining additional samples from leukemia patients and healthy~     volunteers. The investigators are particularly interested in samples from individuals who~     have diseases that can be treated with a new type of drug called immunotoxin, in which an~     antibody carrying a toxin binds to a cancer cell and allows the toxin to kill the cell.~      Objectives:~      - To collect a variety of clinical samples, including blood, urine, lymph samples, and other~     tissues, in order to study the samples and develop new treatments for leukemia.~      Eligibility:~      - Individuals 18 years of age and older who have been diagnosed with leukemia or other kinds~     of blood and lymphatic system cancers, or who are healthy volunteers.~      Design:~        -  Individuals who have leukemia will be asked to provide blood, bone marrow, urine, and~          tumor tissue samples as requested by the researchers. Healthy volunteers will provide~          only blood and urine samples.~        -  No treatment will be given as part of this protocol.~   "
189253|NCT01087320|"~     Background:~      - A number of rare inherited diseases affect only a few patients, and the genetic causes of~     these conditions remain unknown. Researchers are studying the use of a new technology called~     whole genome sequencing to learn which gene or genes cause these conditions. Understanding~     the genes that cause these diseases is important to improve diagnosis and treatment of~     affected patients.~      Objectives:~        -  To identify the genetic cause of disorders that are difficult to identify with existing~          techniques.~        -  To develop best practices for the medical and counseling challenges of whole genome~          sequencing.~      Eligibility:~        -  Individuals who have one of the rare disorders under consideration in this study. These~          conditions are generally those in which the genetic cause of the disorder is unknown.~          The eligibility of most individual participants will be decided on a case-by-case basis~          by the researchers.~        -  Family members of affected individuals, if that family member (often a parent) may~          provide genetic information.~      Design:~        -  Participants in this study will have at least one and in some cases several of the~          following procedures:~        -  A medical genetics evaluation.~        -  Other tests that may include x-rays, magnetic resonance imaging (MRI) exams, and~          consultations with other doctors. Not all studies are necessary for each person, but the~          information from the tests may be required to proceed with some of our gene sequencing~          studies.~        -  Clinical photographs to document certain aspects of the disorder.~        -  Blood and skin biopsy samples, or other tissue samples, as required by the study~          doctors.~        -  Genetic testing, as decided by the researchers. However, most participants in this study~          can expect to undergo whole genome sequencing, which is a technique to study all of a~          person s genes.~        -  Some participants may be asked to take part in a telephone interview and/or a web-based~          survey.~        -  Participants will have choices about what kinds of results from whole genome sequencing~          they wish to learn.~        -  After the tests have been completed and the results of the genetic studies are known,~          participants will be offered a return visit to the National Institutes of Health to~          learn these results. During this visit, participants will be asked to complete surveys~          and participate in interviews related to their decisions to participate in the study and~          to learn individual genetic test results.~   "
189254|NCT01087307|"~     Background:~      - Researchers are interested in developing a registry protocol to obtain biologic and~     environmental samples anonymously from adult volunteers for use in laboratory tests and~     studies. The samples will be used to determine if new tests are sufficiently valid and~     precise to be used in research studies and for quality control purposes.~      Objectives:~      - To provide a registry of samples for test development, validation, analysis, and quality~     control at the National Institute of Environmental Health Sciences.~      Eligibility:~      - Male and nonpregnant female volunteers at least 18 years of age.~      Design:~        -  Samples to be collected will include blood, urine, saliva, household dust, cheek cells,~          hair, nasal cells, stool, nail clippings, exhaled breath condensate, or sperm.~        -  Specimens may be collected during a one-time sample collection, or participants may be~          asked to provide specimens on several occasions over a specified period, not to exceed 1~          year.~        -  Eligible participants will be asked to come to the clinical research unit to have their~          blood drawn and any noninvasive samples retrieved. Prior to blood draw, researchers will~          administer a brief past 24-hour questionnaire for research purposes. Specimens will be~          collected using standard clinical protocols.~        -  Participants will receive monetary compensation for providing samples for this protocol.~   "
189255|NCT01087294|"~     Background:~        -  Allogeneic hematopoietic stem cell transplantation (alloHSCT) is a procedure that~          transplants bone marrow cells (stem cells) from a matching donor into a recipient in~          order to allow the donor stem cells to produce cells that will attack the recipient s~          cancer cells. AlloHSCT is performed when chemotherapy, immunotherapy, or radiation~          therapy do not adequately control cancer growth. However, cancers that are not~          controlled by alloHSCT frequently become resistant to other standard treatment options.~        -  The outcomes of alloHSCT might be improved if certain kinds of white blood cells (T~          cells) could be manipulated so that they generate a more potent effect against the~          cancer cells. This effect can be augmented by genetically engineering donor T cells to~          specifically recognize cancerous cells in order to attack them. For this purpose,~          researchers are studying a specific kind of genetically engineered T cell known as the~          anti-CD19-CAR-transduced T cell. More research is needed to determine if this T cell~          will be an effective treatment for certain kinds of B cell cancer (such as non-Hodgkin s~          lymphoma and chronic lymphocytic leukemia) that has not been controlled with alloHSCT.~      Objectives:~      - To assess the safety and effectiveness of administering allogeneic anti-CD19-CAR-transduced~     T cells to patients with B-cell cancer that has not responded to alloHSCT.~      Eligibility:~        -  Individuals between 18 and 75 years of age who have received allogeneic hematopoietic~          stem cell transplantation for a B cell cancer, but whose cancer has either not responded~          to or recurred after the transplant.~        -  Recipients must have the same stem cell donor from their previous procedure.~      Design:~        -  Before the start of the study, all participants will be screened with a medical history~          and blood tests. Recipients will have tumor imaging scans, additional blood tests, and~          other tests as directed by the study doctors.~        -  Donor participants will undergo apheresis to provide white blood cells for researchers~          to use in the treatment.~        -  Recipients will have dose escalation to determine the most effective yet safe dose of~          anti-CD19 T cells. There will be four dose levels of anti-CD19 T cells. The first~          patients enrolled will have the smallest dose, and the dose will be increased when a~          level has been determined to be safe. To reduce the risk of side effects, participants~          who received a stem cell transplant from an unrelated donor will receive a lower dose of~          anti-CD19 T cells than those who received a transplant from a related donor.~        -  Recipients will be hospitalized for 3 days after receiving the cell infusion, and will~          need to come to clinic for follow-up visits 1, 2, 3, 4, 8, and 12 weeks after the~          infusion.~        -  Additional scans and frequent blood tests will be required for the first 3 months after~          the infusion, followed by less frequent visits over time.~        -  Recipients will be followed for a maximum of 15 years after receiving the infusion.~   "
189288|NCT01086865|"~     Clinical study phase III, randomized, double-blind, prospective, comparative non-inferiority~     to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC in~     appetite stimulate in children, adults and elderly.~   "
189256|NCT01087281|"~     Background:~      - Previous studies have shown that people with certain types of brain damage may have~     particular problems paying attention and processing things that they see. Researchers are~     interested in comparing how people with brain damage and without brain damage process visual~     images.~      Objectives:~      - To better understand the areas of the brain involved in paying attention to things that are~     seen.~      Eligibility:~      - Individuals at least 18 years of age who either have had damage to one or both sides of~     specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are~     healthy volunteers.~      Design:~        -  The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each~          visit will last approximately 2 hours.~        -  Participants will be screened with a medical history and physical examination, and may~          have the cognitive testing described below during the same visit.~        -  On the first visit and for at least one visit thereafter, participants will have~          cognitive testing to evaluate thinking and memory. These tests will be either written~          tests or computer-based tests.~        -  Some participants will qualify for functional magnetic resonance imaging (fMRI) as part~          of the study. This part will involve a decision-making task that will be performed on a~          computer during the fMRI scan. Additional scans may be required as directed by the study~          doctors.~        -  Some randomly selected participants will be asked to have magnetoencephalography (MEG),~          a procedure to record very small magnetic field changes produced by brain activity.~        -  During the behavioral training, or fMRI or MEG scanning, participants may be monitored~          with equipment to track eye movements.~   "
189257|NCT01087268|"~     RATIONALE: Radiation therapy can cause long-term adverse effects. Hyperbaric oxygen therapy~     may be effective in lessening gastrointestinal symptoms caused by radiation therapy given for~     pelvic cancer. It is not yet known whether high-pressure oxygen is effective in treating~     adverse effects caused by radiation therapy.~      PURPOSE: This randomized phase III trial is studying hyperbaric oxygen therapy to see how~     well it works in treating long-term gastrointestinal adverse effects caused by radiation~     therapy in patients with pelvic cancer.~   "
189258|NCT01087255|"~     The objective of this pilot study is to explore barriers to medication adherence among HPHC~     members with CKD, particularly those not yet on dialysis, and to assess the feasibility and~     acceptability of a wireless, internet-based MedMinder system intervention among HPHC~     enrollees with CKD and their care partners. The investigators hypothesize that the~     intervention will improve medication use and adherence among patient members with CKD on~     complex medication treatment, and improve informal caregivers' ability to provide support for~     improved medication use among patient members.~   "
189259|NCT01087242|"~     This is a randomized, doubled blind, dose-paralleled control, multi-centre clinical trail,to~     evaluate the efficacy of Tang-min-ling pills in the treatment of type 2 diabetes mellitus.~   "
189260|NCT01087229|"~     The purpose of this study is to determine whether or not the use of an equimolar mixture of~     oxygen and nitrous oxide during the physical therapy for patients suffering from frozen~     shoulder (adhesive shoulder capsulitis) results in a gain in shoulder amplitude (Constant~     Score) and less pain as compared to patients undergoing physical therapy without this~     treatment.~   "
189261|NCT01087216|"~     The treatment of vitiligo remains disappointing especially in some localization such as bony~     prominences and extremities. The association of UVB and topical steroids has been proven to~     be synergistic but the results are still insufficient in those difficult to treat areas.~     Promising results have been shown with the combination of laser assisted dermabrasion,~     topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin~     followed by topical steroids should potentialized the effect of UVB and be superior to~     topical steroids and UVB without dermabrasion.~      The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion~     combined to topical steroids and UVB phototherapy in difficult to treat areas.~      Patients with symmetrical non segmental vitiligo will be included in this prospective~     randomized monocentrer study. The investigators calculated the number of patients needed at~     25. The side that will receive the dermabrasion will be centrally randomized and the opposite~     side will serve as control. Then on both side class 3 topical steroids will be applied daily~     3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks.~      The evaluation will be performed by two independent physician blinded to the treatment of~     standardized photos before and 1 month after the end of the treatment. The criteria of~     success will be at least 75% of repigmentation.~   "
189262|NCT01087203|"~     The purpose of this study is to determine the effectiveness and safety of the investigational~     drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.~   "
189263|NCT01087190|"~     It has been recommended that all transplant recipients undergo a tuberculin skin test (TST)~     before transplantation. However, the ability of TST to diagnose latent tuberculosis infection~     (LTBI) in transplant candidates has been reported to be suboptimal because of high rates of~     false-negative and false-positive results. The enzyme-linked immunospot assay (ELISPOT)~     detecting interferon-gamma secreting T-cells for diagnosing tuberculosis infection gave~     promising results in immunocompromised patients as well as in immunocompetent patients. The~     investigators will perform a randomized, open-label, prospective trial of isoniazid (INH)~     prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients.~   "
189264|NCT01087177|"~     The study involves the testing of a Pedialink module through parent exit interviews in one~     intervention practice and one control practice. Pedialink is the American Academy of~     Pediatrics' online home for continuous professional development. The intervention site will~     complete the Pedialink module and the control site will be given routine tobacco control~     materials.~      We will measure changes in practice patterns in the two pediatric practices following the~     implementation of the online training. At each of these practices, the parents or guardians~     of children seen by the practice will be surveyed for a one week period before, and a one~     week period six weeks after either using the online training module (intervention) or being~     given routine tobacco materials (control).~      A follow-up telephone survey will be given to some parents at 3-months. Those given the~     telephone survey are parents or guardians who smoke or parents or guardians who live with a~     smoker and are surveyed at the second time-point.~      We hypothesize that intervention practices will have higher rates of screening for home and~     car no-smoking rules and higher rates of advising for home and car no-smoking rules.~   "
189265|NCT01087164|"~     Using health behavior theories and theories related to the effects of persuasive messages~     (i.e., inoculation theory), we plan to: 1. Systematically test the effects of brief~     persuasive message interventions on receipt of the first dose of HPV vaccine; and 2. evaluate~     the effects of the interventions on followup with subsequent doses of vaccine (using reminder~     notices with persuasive message content). One set of interventions will involve a comparison~     of a 1 sided message, which only emphasizes the positive aspects of a recommended behavior,~     with a 2 sided message, which presents negative aspects of the behavior followed by positive~     counterarguments. A second set of interventions will involve a test of a social compliance~     (foot-in-the-door technique, in which half of the parent participants will be asked to~     respond to a high compliance request (i.e., a request likely to generate high compliance,~     such as, Do you want to protect your daughter from cancer? or for male children, Do you~     want to protect your son from genital warts?before subsequently being asked about actually~     having their adolescents vaccinated. The other half of the parents will not receive a high~     compliance request. Parents of 11-14 year old adolescents will be randomized to the two sets~     of interventions, resulting in a 2 X 2 design: message sidedness (1 sided; 2 sided) and~     social compliance request (yes; no). The specific aims of this proposal are to evaluate the~     1) efficacy of 2 sided vs. 1 sided messages on rates of HPV vaccination; 2) the efficacy of a~     social compliance intervention on rates of HPV vaccination; and 3) potential moderators and~     mediators of message effect on vaccine acceptance.~   "
189266|NCT01087151|"~     This Phase II, randomized, open-label, international, multicenter trial is designed to~     evaluate the safety and efficacy of rituximab monotherapy when given according to a dose~     intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when~     combined with dose-intense rituximab in previously untreated patients with B-cell CLL.~   "
189267|NCT01087138|"~     To determine if increasing the amount of calcium that girls eat or the degree of exercise in~     which they participate will increase their bone strength.~   "
189268|NCT01087125|"~     The purpose of the abatacept pregnancy registry is to monitor planned and unplanned~     pregnancies exposed to abatacept, to evaluate the possible teratogenic effect and to follow~     live born infants for one year after birth.~   "
189269|NCT01087112|"~     An RCT comparing mother-infant psychoanalytic treatment (MIP) with Child Health Centre care~     in cases of mother-infant relationship disturbances was performed on 80 cases in Stockholm~     2005-2008. The infants were < 18 months at interview #1. At 6 months follow-ups, significant~     effects were shown in favour of MIP on maternal sensitivity (EAS), depression (EPDS), and~     relationship qualities PIR-GAS). This study will evaluate effects at a child age of 4½ years;~     to evaluate the longterm effects of MIP and CHild Health Centre care, and to better validate~     results on children who now have reached an age where they can participate more actively in~     evaluations.~   "
189270|NCT01087099|"~     The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator~     americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent~     parasites worldwide. The objective of this multicentre international study is to define the~     efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a~     standardised protocol. The trial will be undertaken among school age children in seven~     countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam -~     each with a different epidemiologic pattern of infection. A trial of this nature is urgently~     required because in spite of the wide usage of albendazole over the last 3 decades, there is~     still no key publication reporting the efficacy of the anthelmintic accurately, and to modern~     conventional standards, that can act as a central reference for the baseline efficacy. The~     latter is critically important because albendazole is now being used even more widely, as~     large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the~     intention of reducing morbidity in children. Such large scale usage of a drug risks~     resistance developing, but resistance cannot be detected unless benchmark values for baseline~     efficacy are widely known.~   "
189271|NCT01087086|"~     The purpose of this study is to determine whether a dietary pattern based on crononutrition~     and dietary training, together with dietary and psychological control, can reduce the body~     weight, improve the oxidative and inflammatory state in subjects with diagnosed metabolic~     syndrome features and can reduce the prevalence of the Metabolic syndrome in the population.~   "
189272|NCT01087073|"~     The Improving Diabetes Care and Outcomes project aims to reduce diabetes disparities and~     engages patients, providers, clinics, and community collaborators to improve the health care~     and outcomes of African-Americans on the South Side of Chicago. Initiated in 2009, this~     project is a collaborative, community-based intervention that employs a multifaceted,~     integrated approach to address many of the root causes of health disparities. The short-term~     goal of this project is to improve clinic processes such as appointment scheduling and~     patient counseling through quality improvement efforts, as well as clinical outcomes~     including HbA1c, cholesterol and blood pressure in patients with diabetes through patient~     education. Long-term goals are to strengthen the network of community health centers,~     community-based organizations and academic medical centers, while increasing awareness of~     local diabetes disparities and empowering communities to combat this problem.~   "
189273|NCT01087060|"~     The aim of this study was to show additional diagnostic criteria of computed tomography (CT)~     scan to diagnose and predict the detection and recurrence of cystic renal cell carcinoma in~     the patients with complicated renal cysts. Furthermore, we would demonstrate the relationship~     between complicated renal cysts diagnosed by Bosniak system and some parameters of~     pathological results. The analysis about detection time of renal malignancy would help~     determine the practical guidelines of follow-up plan for complicated renal cysts.~   "
189316|NCT01086488|"~     Objectives:~      Primary objective~      - To determine the efficacy of Foscan-PDT compared with Brachytherapy for recurrent or~     persistent NPC, as determined by macroscopic clinical examination, CT scan and biopsy. The~     primary endpoint is complete tumour response at 6 months.~      Secondary objective:~        -  To determine the response rates, e.g. presence of tumour on endoscopy, time to~          progression and overall survival in patients treated with Foscan-PDT compared with~          brachytherapy~        -  To determine the quality of life, as derived from the University of Washington Quality~          of Life questionnaire in patients treated with Foscan-PDT compared with brachytherapy~        -  To evaluate the safety of Foscan-PDT compared with brachytherapy in terms of adverse~          events and serious adverse events.~   "
189274|NCT01087047|"~     It is well known that airway management can be difficult during pregnancy. Increased risks~     for difficult intubation in pregnant women have been often reported. Thus, pregnancy is~     regarded as a period of high anesthesiologic risk.~      Generalized weight gain is a well known factor influencing the upper airway in pregnant~     women. However, the modifications of the airway itself are less well documented.~      The acoustic reflection method is based on the analysis of the reflection of a single~     transient planar wave allowing the analysis of the longitudinal cross-sectional area profile~     of the examined cavity. It is a noninvasive and harmless method.~      The aim of the study is to evaluate by acoustic reflection method the physiological~     modifications of the upper airways during pregnancy.~      Women enrolled in the study will undergo an acoustic recording during the first, second, and~     third trimester of pregnancy, as well as two days and one month after delivery. Forty~     pregnant women will be included in this monocentric, prospective, open labelled study.~      Moreover, a single acoustic recording will be performed in 10 other pregnant women undergoing~     an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and~     acoustic method will be compared.~   "
189275|NCT01087034|"~     Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may~     impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal~     deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent~     curve progression, which may affect respiratory function.~      The acoustic reflection method is based on the analysis of the reflection of a single~     transient planar wave giving the longitudinal cross-sectional area profile of the examined~     cavity. It is noninvasive and harmless.~      The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with~     thoracic 3D reconstruction.~      The aim of the study is to evaluate the impact of bracing on the upper airways patency (by~     means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles~     assessment), and on the thoracic penetration index (by means of the EOS™)~   "
189276|NCT01087021|"~     Primary Objective:~        -  To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in~          cancer patients~      Secondary Objectives:~        -  To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction),~          and QTcN (population specific correction) intervals~        -  To assess the clinical safety of cabazitaxel~        -  To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during~          infusion and up to 5h post end of infusion)~   "
189277|NCT01087008|"~     Assessment of the antitumour effect of zoledronic acid in patients with multiple myeloma and~     asymptomatic biochemical relapse~      It´s proposed to investigate the use of Zoledronic acid as single therapy in patients with~     Multiple Myeloma in biochemical relapse. The following must be noted:~        -  Patients with no formal indication for chemotherapy treatment will be included, as~          patients with symptomatic myeloma who after responding show biochemical relapse are~          generally not treated. This allows for generating both a group of patients untreated, on~          no additional treatment and a treatment group on zoledronic acid.~        -  As these are relapsing symptomatic patients, their number is far higher than patients~          with quiescent Multiple Myeloma. This allows for expecting a good enrolment.~        -  There are few reliable data on symptom progression after biochemical relapse, though it~          is one of the new objectives occurring in almost all clinical trials on myeloma. In the~          VISTA study, it has been estimated that the median time to the new treatment is 5 months~          (combining progression-free time and time to the next treatment). This time is much~          shorter than the median quiescent myeloma progression-free survival, so a very long~          follow-up time will not be necessary in this patient group.~        -  The administration of this drug to these patients can help prevent skeleton-related~          complications in the future, the study of which will be a secondary objective of this~          study.~   "
189278|NCT01086995|"~     The purpose of this study is to determine if variability in heart and breathing rates can be~     used to predict successful weaning. We are collecting data to determine whether or not subtle~     differences in heart rate and respiratory function will help physicians to decide if a~     patient is ready to be weaned.~   "
189279|NCT01086982|"~     Check the pharmacodynamics of the drug octreotide acetate LAR 30 mg imported and distributed~     by Chemical Laboratory Pharmaceutical Bergamo Ltda. compared to the drug Sandostatin LAR ®~     (octreotide acetate 30 mg) manufactured by Novartis Biociências S / A, using as activity~     analysis of growth hormone (GH) and growth factor insulin-like 1 (IGF-1 ) after a single dose~     of the drug in patients with acromegaly~   "
189280|NCT01086969|"~     The purpose of this study is to assess the safety and immunogenicity of a single dose of~     Menactra® vaccine to support registration.~      Primary Objectives:~        -  To describe the antibody titers measured by serum bactericidal activity using baby~          rabbit complement (SBA-BR) before and after Menactra® vaccination.~        -  To describe the safety profile of participants after one dose of Menactra®.~   "
189281|NCT01086956|"~     The purpose of this study is to compare metabolic and stress responses in combined~     general/epidural anesthesia in geriatric cancer patients.~   "
189282|NCT01086943|"~     The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in~     the eyelids.~      Prospective, non comparative, open, monocentre study.~      The objectives are:~        -  To verify and establish the temperature of the eyelids and cornea for each eye before~          and after 10 minutes device application~        -  To evaluate the ocular surface, NIBUT and IOP before and after device application~        -  To determine the acceptability of healthy volunteers on the practical use of this device~      The subjects will attend 2 visits.~   "
189283|NCT01086930|"~     Loss of hand function is one of the most devastating consequences of tetraplegia because of~     the severe impact on activities of daily living (ADL) and the resultant dependency on others.~     This multi-centre study in 78 participants will measure whether additional hand therapy~     provided via an electrical stimulator glove and specialised computer workstation improves~     hand function in people with tetraplegia.~   "
189284|NCT01086917|"~     The study is a single center, varied dose, open label study. A maximum of eighteen volunteers~     will be exposed to live NF54 P. falciparum sporozoites (PfSPZ Challenge) by intradermal~     injection. Volunteers will be divided into three groups of 6 volunteers, each group spaced 25~     days apart (21 days after the last challenge of the last volunteer from the previous dose~     group).~   "
189289|NCT01086852|"~     To primary efficacy variable is to assess the presence or absence of excessive blood loss~     during and after surgery.~      The secondary efficacy endpoints are as follows:~        1. A subjective overall assessment by the investigator of FACTOR X in the control of~          bleeding during surgery.~        2. The incidence of bleeding episodes during treatment with FACTOR X while the subject is~          at risk of post-operative bleeding, including location and duration.~        3. Incremental recovery of FX:C and FX:Ag after the pre-surgery bolus infusion.~        4. Assessment of FX:C and FX:Ag levels on each day post-surgery.~        5. Assessment of the cumulative weight-adjusted doses of FACTOR X as measured by FX:C~          (IU/kg body weight) administered to each subject to maintain haemostasis.~        6. Assessment of the cumulative doses of FACTOR X as measured by FX:C (IU) administered to~          each subject to maintain haemostasis.~        7. Amount of weight-adjusted FACTOR X as measured by FX:C (IU/kg body weight) administered~          daily (day of surgery and each post-operative day) to maintain haemostasis.~   "
189290|NCT01086839|"~     Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic~     defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns~     upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation~     with bacterial superinfection.~      In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and~     throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the~     airways.~      The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial~     aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic~     saline with respect to ENT-related quality of life which is influenced by mucus retention and~     the resulting inflammation.~   "
189291|NCT01086826|"~     This is a randomized multicenter open label phase III factorial trial evaluating the 3 years~     OS in patients with locally advanced squamous cell carcinoma of head and neck treated with~     locoregional treatment (radiotherapy plus concomitant chemotherapy or cetuximab) with or~     without neoadjuvant chemotherapy.~   "
189292|NCT01086813|"~     Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics~     and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a~     Single Infusion Dose in Elderly(=65 years) Healthy Volunteers~   "
189293|NCT01086800|"~     This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.~   "
189294|NCT01086787|"~     The investigators hypothesize that chronic heart failure is associated with a general stem~     cell dysfunction, which translates into reduced paracrine function of adult stem cells from~     patients with chronic heart failure as compared to patients with preserved systolic function.~   "
189295|NCT01086774|"~     Evaluation of the optical effects of Systane Ultra~   "
189296|NCT01086761|"~     The purpose of this study is to assess the safety and tolerability of MP0112 (a novel,~     potentially long acting VEGF inhibitor) in patients with wet Age Related Macular~     Degeneration.~   "
189297|NCT01086748|"~     An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill~     patients with schizophrenia.~   "
189298|NCT01086735|"~     The main complications of allogeneic hematopoietic stem cell transplantation (HSCT) include~     graft-versus-host disease (GVHD) and poor immune reconstitution leading to severe infections~     and leukemia relapse. Mature donor T-cells present in the transplant facilitate T-cell~     reconstitution but also induce GVHD, which itself impairs immune reconstitution. We have~     developed a strategy of alloreactive T-cell depletion, using T-cells expressing the Herpes~     simplex thymidine kinase (TK) suicide gene combined with a ganciclovir (GCV) treatment. This~     system permits the selective elimination of dividing TK+ T-cells in vivo. To test this~     hypothesis in preclinical settings, we have previously developed several experimental models~     of GVHD using TK+ T-cells in mice. The demonstration that a preventive treatment with GCV~     administered close to the time of HSCT could control GVHD brought the proof of concept. We~     now propose a clinical trial to test whether donor lymphocytes infusion (DLI) using~     TK-transduced cells permits to induce a graft-versus-tumor (GVT) effect for treatment of~     relapse after HSCT, while GVHD can be controlled by GCV treatment.~   "
189299|NCT01086722|"~     Morbid obesity (MO) is associated with several disorders such as hypertension, type 2~     diabetes, dyslipemia and degenerative arthropathy that require pharmacological treatment.~     Drug bioavailability and metabolism in patients with MO is altered compared to population~     controls. Bariatric surgery is the gold standard treatment for MO when conventional therapy~     fails.~      Bariatric surgery techniques can modify drug absorption in MO patients. These modifications~     depend on the drug absorption characteristics and on the bariatric surgery technique used.~     The changes in weight and body composition caused by BS at middle term can alter drug~     bioavailability and metabolism. The kinetics of the normalization process in patients with~     MO after bariatric surgery is unknown~      Objectives. To analyze the changes in drug metabolism and pharmacokinetics. To establish drug~     dosing criteria in the post-intervention period in patients with MO after bariatric surgery.~     To determine the relationship between changes in drug bioavailability and metabolism in MO~     after bariatric surgery (longitudinal gastrectomy and Y-roux gastric by-pass).~   "
189300|NCT01086709|"~     Background:~      - National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial,~     was a double-blind controlled study of the effectiveness of an experimental human~     papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica.~     Costa Rica was part of the first large study to show the association between HPV and cervical~     cancer, and the study contributed greatly to the understanding of this association. The women~     who have participated in the vaccine trial in Costa Rica are reaching the end of the~     follow-up period offered in the vaccine trial protocol, and as a result they are being~     offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis~     B.~      Objectives:~        -  To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not~          receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and~          hepatitis B vaccination.~        -  To collect information about exposure to known and suspected risk factors for HPV~          infection and cervical cancer from women who are receiving vaccination against HPV at~          crossover.~      Eligibility:~      - Women who participated in National Cancer Institute Protocol 04-C-N191.~      Design:~        -  All participants will be offered vaccination against hepatitis B.~        -  Women who received the hepatitis A vaccine during the trial will be offered vaccination~          against HPV.~        -  Women who received the HPV vaccine during the trial will be offered vaccination against~          hepatitis A.~        -  Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will~          be available to reduce the number of injections that participants will be asked to~          receive.~        -  All vaccines will be given according to the manufacturer's specifications for~          appropriate length of time between vaccine doses.~   "
189317|NCT01086475|"~     The purpose of this study is to determine the effectiveness of D-cycloserine for improving~     social impairment in child with pervasive developmental disorders (PDD).~   "
189318|NCT01086462|"~     This study is a first administration to man microdose study to describe the pharmacokinetics~     of GSK2239633.~   "
189301|NCT01086696|"~     Background:~        -  Paclitaxel is a chemotherapy drug that is commonly used to treat different types of~          cancers. However, cancer tumors can become resistant to paclitaxel, and as a result they~          will fail to accumulate sufficient concentrations of paclitaxel to kill the cancer~          cells. Researchers are interested in studying whether tumors have become resistant to~          paclitaxel, but to do so it must be possible to see how much paclitaxel is absorbed by~          the tumor cells.~        -  18F-Fluoropaclitaxel (FPAC) is a form of paclitaxel that has been modified to be~          slightly radioactive in order to show up on positron emission tomography (PET) scans. By~          injecting a very small amount (much less that that used to treat tumors) of the~          radiolabeled drug into the body, researchers hope to use PET scans to evaluate the~          amount of the drug absorbed by solid tumors. Because FPAC is best used to study tumors~          located above the diaphragm, all subjects in the study will have tumors near or above~          the diaphragm.~      Objectives:~      - To determine the safety and effectiveness of FPAC as a radiological evaluation chemical.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with breast, adrenal, renal,~     or lung cancer and have a tumor located someone in the body at least 1 centimeter above the~     diaphragm.~      Design:~        -  Participants will be screened with a physical exam, blood tests, and imaging studies as~          directed by the study researchers.~        -  Participants will receive a single dose of FPAC, followed by a series of PET scans.~          Regular scans will be performed for 3 hours after the dose of FPAC.~        -  Participants will also have a single dose of a more conventional radiotracer, followed~          by a series of PET scans. The results of the two sets of scans will be compared with~          information from previous imaging studies of participants' tumors.~   "
189302|NCT01086683|"~     This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential~     rehabilitation course at a Danish rehabilitation centre for cancer survivors. The~     investigators hypothesize that individuals in the intervention group will experience better~     psychosocial well-being and more adaptive health behaviour changes as compared to individuals~     in the control group.~   "
189303|NCT01086670|"~     Background:~        -  Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs~          and causes difficulty with leg movement and walking. Research has shown that exercise~          can help those with CP learn to move their arms better, but more research is needed to~          determine whether exercise programs can improve leg movements in people with CP.~        -  Walking on a treadmill with the help of a physical therapist has improved the treatment~          outcomes of some individuals with spinal cord injuries. Many children with CP already~          have physical therapy but still have trouble with walking and leg coordination. Two~          other kinds of exercise machines, a stationary bicycle and an elliptical machine, used~          in the home, may be able to help children with CP walk better and move their legs~          better.~      Objectives:~        -  To see how children with cerebral palsy (CP) move their legs differently from children~          without CP.~        -  To see if an exercise program can improve leg coordination in children with CP.~      Eligibility:~      - Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy~     volunteers.~      Design:~        -  Children who are able and willing will have magnetic resonance imaging (MRI) scans at~          the start and the end of the study.~        -  During Part I of the study, participants will demonstrate their leg and muscle function~          with the following tests:~        -  Measurement of leg size and movement~        -  Combined camera motion study and electrical impulse evaluation to assess how well the~          participant walks (with or without an assistive device, as needed)~        -  Leg movement tests on an exercise bicycle and elliptical machine~        -  Tests of leg muscle strength, stiffness, and effectiveness~        -  Ultrasound scans of leg muscle~        -  Parents of participants will complete computer-based questionnaires about their child s~          motor abilities.~        -  A smaller group of participants will continue to Part II of the study, which involves~          regular exercise of 20 minutes a day, 5 days a week, for 3 months, on a stationary~          bicycle or elliptical trainer. Half of the group will start this exercise program~          immediately after the first part of the study, while the other half will wait 3 months~          before beginning the exercise program.~        -  During Part II, participants will return to the clinical center for two more sets of the~          tests and evaluations performed in Part I.~   "
189304|NCT01086657|"~     Background:~      - New vaccines against avian influenza, also known as bird flu, are being developed and~     require testing to determine if they are safe and effective and whether they have any side~     effects. Researchers are interested in testing two experimental avian influenza vaccines to~     see whether they are safe, if there are any side effects from the vaccines, and how the~     body's immune response differs in response to different vaccination schedules. One vaccine is~     an inactivated vaccine (made with killed or weakened influenza) and one is a DNA vaccine that~     allows the body to use vaccine to make an immune system response to a specific part of an~     avian influenza protein.~      Objectives:~        -  To determine the safety and potential side effects of two experimental vaccines against~          avian influenza.~        -  To evaluate whether the time between the two experimental vaccine injections affects the~          immune response to the vaccine.~      Eligibility:~      - Healthy individuals between 18 and 60 years of age.~      Design:~        -  Participants will be randomly divided (by chance) into six groups to receive two~          injections of vaccine at different intervals. One group will receive only the~          inactivated vaccine, while the other groups will receive the DNA vaccine followed by the~          inactivated vaccine at different intervals (e.g., 4 weeks, 8 weeks, 12 weeks, 16 weeks~          or 24 weeks later).~        -  Participants will remain at the clinical center for at least 30 minutes after each~          vaccination. A few days after each injection, participants will contact staff by~          telephone or have a clinic visit. Participants will also be asked to complete a diary~          card at home for 5 days to keep track of temperature changes, injection site skin~          changes, and other effects.~        -  Four weeks after the first injection, participants will return for a clinic visit and to~          provide blood samples for testing.~        -  Two weeks after the second injection, participants will return for a clinic visit and~          provide blood samples (collected through apheresis) to provide information on immune~          response to the vaccine.~   "
189305|NCT01086631|"~     Background:~        -  Autoimmune retinopathy (AIR) is an inflammatory condition in which the patient s own~          immune system is attacking his or her eyes and causing vision loss. Patients with AIR~          are generally treated with immunosuppressive agents to treat the eye inflammation;~          however, the standard treatment for this disease is still being developed.~        -  Rituximab, an immunosuppressive agent, is a monoclonal antibody that is directed against~          a part of the immune system that may be an important cause of AIR. Rituximab is approved~          for the treatment of non-Hodgkin s lymphoma and rheumatoid arthritis, but is not~          approved for the treatment of AIR. Researchers are interested in determining whether~          rituximab may be used to treat AIR.~      Objectives:~      - To to investigate the safety, tolerability and possible efficacy of rituximab as a~     treatment for AIR.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with AIR and have visual~     acuity of 20/200 or better in at least one eye.~      Design:~        -  Before the start of the study, participants will be screened with a medical history,~          immunization records, a series of eye examinations, a chest X-ray, an electrocardiogram,~          and blood tests.~        -  Participants will receive a maximum of two cycles of rituximab during the 18-month~          study. Each cycle will involve two separate intravenous infusions of rituximab given 2~          weeks apart.~        -  Participants will return to the clinic 6 weeks after the first cycle of rituximab for a~          safety visit, which will include a routine eye and physical examinations. They will also~          provide blood and other samples for study.~        -  After the safety visit, participants will return every 3 months for follow-up visits.~        -  At the 6-month visit, participants who have successfully or partially responded to~          rituximab will receive another cycle of treatment. Those who do not respond will not~          receive another cycle, but will continue to be monitored until the end of the study.~   "
189306|NCT01086618|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy~     after surgery may kill any tumor cells that remain after surgery. It is not yet known whether~     chemotherapy is more effective when given alone or together with surgery in treating patients~     with colorectal cancer.~      PURPOSE: This randomized phase II/III trial is studying how well chemotherapy works and~     compares it with surgery followed by chemotherapy in treating patients with metastatic~     colorectal cancer that can not be removed by surgery.~   "
189307|NCT01086605|"~     RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in~     treating patients with HER2-negative metastatic breast cancer.~   "
189308|NCT01086592|"~     The purpose of this study is to determine whether neuromuscular electrical stimulation,~     strengthening exercises, or combination of both over lower limbs are effective in the~     improvement of the stability fundamentally against falls, greater independence and,~     therefore, better quality of life in elderly over 75 years.~   "
189319|NCT01086449|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK~     Biologicals' candidate Herpes Zoster (HZ) vaccine in healthy ethnic Japanese adults.~   "
189309|NCT01086579|"~     Prospective multicentre randomized (1:1) investigator initiated study, in which consecutive~     patients undergoing percutaneous revascularization of small coronary vessels will be assigned~     to one of the two study arms:~        1. Treatment Arm: IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and~          provisional spot bare-metal stenting (BMS).~        2. Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.~      Eligible subjects with coronary artery disease in a small vessel (reference diameter<2.8mm)~     will be consecutively screened and enrolled based on the inclusion and exclusion criteria~      The objective of the study is to assess the non-inferiority of the DEB to the PES as regards~     to primary endpoint of mean late lumen loss (LLL) at 6 months, defined as the difference~     between postprocedural minimum luminal (MLD) diameter and follow-up MLD, as assessed by~     quantitative coronary angiography and is based on the following assumptions:~        1. The means of LLL in the 2 groups are precisely equal~        2. A standard deviation in LLL of 0.5mm in both groups as demonstrated in the ISAR-SMART 3~          and PEPCAD II trials~        3. A non-inferiority margin of 0.25mm between groups is clinically unimportant~      Based on these assumptions:~        1. Null hypothesis (N0): mean LLL in DEB group is ≥0.25mm than that in the PES group (i.e.~          PES is superior to DEB)~        2. Alternative hypothesis 1 (H1): mean LLL between DEB and PES is <0.25mm (i.e. DEB is~          non-inferior to PES)~        3. Alternative hypothesis 2 (H2): mean LLL between DEB and PES <0 (i.e. DEB is superior to~          PES) Based on the above calculations, a sample size of 77 patients will be required in~          each group to show non-inferiority of DEB vs. PES with an α error of 0.025 (one-sided Z~          test) and a power of 80%. To account for a 20% rate of withdrawal, lost to follow-up or~          not presenting for follow-up angiography, a total of 182 patients (91 in each group)~          will be randomized.~   "
189310|NCT01086566|"~     The purpose of the study is to evaluate safety and compare how the body reacts to 2 different~     strengths of the Clade (specific type of H5N1 virus) 2 H5N1 flu vaccine when given as a~     single vaccination with a high dose (90 mcg) or low dose (15 mcg) to volunteers who have~     received at least 2 doses of the Clade 1 H5N1 vaccine, in a previous National Institute of~     Health study or who have never received a H5N1 vaccine (naïve). Previously vaccinated~     subjects (in studies 04-0063, 05-0090, 05-0127) will receive either 15 or 90 mcg of H5N1~     vaccine. Multiply boosted volunteers who participated study 05-0043 and received Clade 1 and~     3 vaccines, will receive the same dose (15mcg). Vaccine naïve subjects will receive 2 doses~     of vaccine (15 or 90 mcg) separated by 28 days. Blood samples will be collected. 115~     volunteers age 18-64 may participate in study related procedures for approximately 7 months.~   "
189311|NCT01086553|"~     This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg~     budesonide three-times daily (TID) for the induction of remission in Crohn's disease.~   "
189312|NCT01086540|"~     Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a serious,~     life-threatening manifestation of systemic sclerosis (SSc), an autoimmune disease of the~     connective tissue characterized by scarring (fibrosis) and atrophy of the skin, joints and~     tendons, skeletal muscles, and internal organs, and immunological disturbances. One-year~     survival for patients with SSc-PAH ranges from 50-81%. There is currently no cure for SSc-PAH~     and treatment is limited to vasodilator therapy used in all forms of PAH. In recent studies,~     immunotherapy was shown to be effective in treating SSc-interstitial lung disease, another~     serious, life-threatening manifestation of SSc. In addition, there are compelling~     pre-clinical data and anecdotal clinical reports that suggest modulation of the immune system~     may be an effective strategy for treating SSc-PAH. To test this approach, this trial will~     determine if rituximab, an immunotherapy, has a marked beneficial effect on clinical disease~     progression, with minimal toxicity, in patients with SSc-PAH when compared to placebo.~   "
189313|NCT01086527|"~     Leukotriene receptor antagonists (LTRAs) are frequently prescribed to reduce the symptoms~     associated with asthma. Singulair (montelukast), manufactured by Merck, is a popular LTRA,~     however its effectiveness varies greatly between individuals. We are interested in~     understanding why the effectiveness of Singulair varies so greatly.~      For an oral drug such as Singulair to be effective, the body must efficiently absorb it. We~     have found that blood levels of Singulair vary greatly between individuals, and we think that~     this variability is responsible for variability in response.~      Drug absorption occurs primarily in the intestine. Due to differences in the chemical~     properties of drugs, some drugs can be absorbed easily while other drugs require help from~     special proteins produced by the cells that line the intestine. These proteins, or~     transporters act like revolving doors to allow drugs to move from the intestine to the~     bloodstream. The activity of a transporter can be influenced by individual genetic~     variability.~      We think that adsorption of Singulair requires help from a transport protein called OATP2B1.~     We have found that a single common genetic change in this protein is associated with low~     plasma concentration of montelukast. In this proposal we will determine plasma levels of~     montelukast in individuals with two copies of this genetic change. We predict that these~     individuals will have roughly half the plasma level of montelukast as individuals with no~     copies of this genetic change.~      Eventually, what we learn from this work will allow doctors to quickly test individuals with~     asthma to determine how well they will absorb Singulair and possibly other LTRAs. Knowing~     this will allow the doctor to adjust the drug treatment on an individual basis to maximize~     benefit in the treatment of asthma.~   "
189314|NCT01086514|"~     Breast tumors are normally seen with mammography or ultrasound without the use of a dye but~     the size and extent of the tumor may be hard to see. Currently, after initial mammography,~     many patients undergo bilateral breast MR to further stage the local tumor. It is able to not~     only detect anatomic abnormalities but can also evaluate changes such as the development of~     new blood vessels, which occurs with the development of cancers. MRI is extremely sensitive~     and detects unsuspected disease in up to 25% of patients, which affects their treatment. It~     also detects unsuspected cancer in the other breast in some patients.~      However, MRI is expensive, not always available, and some patients are unable to undergo MRI~     due to the presence of pacemakers, clips, or claustrophobia. Dual Energy Contrast Enhanced~     Digital Mammography (DE CEDM) is an investigational procedure that uses a non-standard~     contrast in a regular digital mammography exam that has been changed to give the needed dual~     energy and image. DE CEDM is not FDA approved. It is our hope that DE CEDM will also be able~     to detect unknown tumors because it will also detect new blood vessels. It is less expensive~     than MRI, could be more available to patients, and can be done on patients with pacemakers~     and clips. Claustrophobia will not be a problem. We plan to see if (DE CEDM) will help us~     better see the breast tumor and size of the breast tumor. We will also want to see if DE CEDM~     can detect additional unsuspected disease in the breast with the known tumor and in the other~     breast without a known tumor.~   "
189315|NCT01086501|"~     The aim of the observational study is to investigate the safety of oxcarbazepine extended~     release (ER) during long-term therapy in epileptic patients. In addition, quality of life~     parameters should be documented if assessed.~   "
189325|NCT01086371|"~     The study is being conducted to determine if a home-based walking program that uses RAS~     (Rhythmic Auditory Stimulation)is a viable and effective treatment of gait instability for~     people with MS.We hypothesize that an RAS-based home walking program will demonstrate~     significant improvements over both regular exercise and no exercise. To test this hypothesis~     we will compare between group differences from baseline and three weeks of intervention on 3~     quantitative gait measures and 1 standardized MS measurement from the following 3 groups: RAS~     walking, RAS no walking Other: Walking exercise The secondary goal of the study will be to~     determine any carry-over effects of RAS on gait parameters in ambulatory patients with MS. We~     hypothesize that RAS will produce sustained changes in gait pattern due to entrainment~     processes. To test this hypothesis, we will compare gait parameters two weeks following the~     cessation of the intervention with baseline and with the last week of intervention.~      The third goal of this study is to determine if RAS-enhanced exercise has any transfer to~     improve other areas such as upper extremity function and/or cognitive function. We~     hypothesize that those participating in an RAS-based home walking program will demonstrate~     improvements in other domain areas, such as cognitive and upper body functioning. To test~     this hypothesis we will compare results from the Multiple Sclerosis Functional~     Composite(MSFC) taken at baseline and again at the end of the treatment phase for all three~     groups.~   "
189326|NCT01086358|"~     Researchers want to learn about work productivity after treatment of a migraine headache with~     your usual migraine medication as compared to your work productivity after treatment with~     Treximet.~      During this research subjects will take Treximet to treat 3 workday migraine attacks. For a~     second part of the research subjects will take their usual prescribed medication for 3~     workday migraine attacks. The subjects will complete questionnaires after treating each~     migraine.~   "
189327|NCT01086345|"~     RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal~     tissue. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of~     glioblastoma by blocking blood flow to the tumor. Drugs used in chemotherapy such as~     irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving radiosurgery together with~     bevacizumab and irinotecan hydrochloride may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving radiosurgery together with~     bevacizumab and irinotecan hydrochloride works in treating patients with recurrent~     glioblastoma.~   "
189328|NCT01086332|"~     This study is designed to evaluate if nelfinavir works as a radiation sensitizer in~     combination with gemcitabine (a chemotherapy). We are also looking to establish the maximum~     dose of gemcitabine that is tolerated with the nelfinavir and radiation therapy, so the dose~     of gemcitabine is increased based on how previous trial participants tolerated their dose of~     gemcitabine.~   "
189329|NCT01086319|"~     The purpose of this study is to compare the incidence hospitalization for severe~     hypersensitivity and cutaneous reactions among patients with type 2 diabetes who are new~     users of saxagliptin and those who are new users of other oral antidiabetic drugs.~   "
189330|NCT01086306|"~     The purpose of this study is to compare the incidence of hospitalizations for infections~     among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those~     who are new initiators of Oral Anti-Diabetic Drug (OADs) in classes other than DPP4~     inhibitors; and to compare the incidence of hospitalizations with infections associated with~     T-lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial~     infections [evaluated as a composite outcome]) among patients with type 2 diabetes mellitus~     who are new initiators of Saxagliptin and those who are new initiators of OADs in classes~     other than DPP4 inhibitors.~   "
189331|NCT01086293|"~     The purpose of this study is to compare the incidence of hospitalization with acute liver~     failure among patients with type 2 diabetes who are new users of Saxagliptin and those who~     are new users of other oral antidiabetic drugs.~   "
189332|NCT01086280|"~     The purpose of this study is to compare the incidence of major cardiovascular events among~     patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new~     initiators of oral anti-diabetic drugs (OADs)in classes other than Dipeptidyl peptidase IV~     (DPP4) inhibitors.~   "
189333|NCT01086267|"~     The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in~     combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when~     administered alone or in combination with cetuximab~   "
189334|NCT01086254|"~     Primary Objective:~        -  to assess the objective response rate (ORR) of Iniparib (SAR240550) administered as a~          60-min intravenous infusion twice weekly, when combined to gemcitabine/cisplatin~          chemotherapy regimen (GCS) as well as with the standard regimen of gemcitabine/cisplatin~          (GC) in patients with stage IV non small cell lung cancer.~      Secondary objectives are:~        -  to assess the safety profiles of the study combination GCS and of the standard regimen~          GC;~        -  to assess the progression free survival and the overall survival in both arms;~        -  to assess the relationship between DNA repair pathway characteristics of tumors at~          baseline and clinical outcome of disease.~        -  to assess the effect of Iniparib on PAR level in peripheral blood mononuclear cells~          (PBMC). (As of 10 September 2010, the collection of PBMC is temporarily discontinued.)~   "
189335|NCT01086241|"~     Tomosynthesis is a new digital mammographic tool which can be performed at the same time as~     routine screening mammography. It creates CT-like slices through the breast, minimizing the~     tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by~     increasing cancer detection rates, decreasing false negative rates and false positive rates.~     This trial will help determine if tomosynthesis is useful in a screening setting.~   "
189336|NCT01086228|"~     The objectives of this post-marketing surveillance, conducted in Japan, is to know the~     frequency, type and degree of device malfunction, to assure the safety of the medical device,~     and to collect information on evaluation of the efficacy and safety.~   "
189337|NCT01086215|"~     The Registry involves the collection of information for research and educational purposes~     only on the use of AngioJet in the peripheral vascular system.~   "
189338|NCT01086202|"~     The purpose of this study is to prospectively evaluate two FDA approved implant designs for~     the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of~     offset each implant has. This offset may improve clinical outcomes in the patient population.~     There have been no clinical comparative studies between these two designs in the literature~     to date. We would like to follow these patients for two years after implantation of the~     reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores.~     this would be the first randomized prospective single blinded study of its kind.~   "
189339|NCT01086189|"~     Green tea consumption could lower the risk of type II diabetes, as suggested by~     epidemiological studies. There is also evidence from intervention studies that green tea can~     decrease blood glucose levels and contribute to weight loss.~      The aim with this study is therefore to examine the postprandial effects of green tea on~     glycemic index, insulin levels and satiety in healthy individuals after the consumption of a~     meal.~   "
189340|NCT01086176|"~     The purpose of this study is to see how long does the effect of a post-tetanic facilitation~     last on subsequent train-of-four. The investigators hypothesis is that the effect last at~     least 30 minutes.~   "
189341|NCT01086163|"~     Omacor®/Lovaza® is an effective, and very safe mix of PO-3A, and the drug is currently~     approved by the Federal authorities for the drug management of post-infarction patients with~     high blood triglycerides. Given the growing length of CAD progression, it is pertinent that~     many more patients will yield extra benefit from Lovaza® on top of aggressive antiplatelet~     regimens and statin due to severity of their vascular disease. Therefore, mild antiplatelet~     properties of PO-3A will be a highly desirable and attractive commodity of this medication.~      The investigators believe that Omacor®/Lovaza® is ideally positioned for the chronic~     management of CAD as a safe, efficient, and gentle agent with no harmful interactions with~     statins or aspirin.~      The investigators hypothesize that addition of Omacor may add mild antiplatelet protection~     for CAD patients.~      The study objectives are:~        -  To assess the ex vivo effects of Omacor® on platelet function in patients with coronary~          artery disease (CAD).~        -  To compare ex vivo platelet-related effects after 7 and 14 days of therapy with Omacor~          and statin combination versus statin alone in patients with chronic stable coronary~          heart disease.~        -  To establish the relation of changes in platelet activity (if any) with the lipid~          profile to prove an additional benefit of Omacor® on top of statin and aspirin.~   "
189342|NCT01086150|"~     The purpose of this study is to see if an investigational drug known as the lidocaine 5%~     patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how~     topical lidocaine affects the nerve endings, and to determine whether treatment with the~     lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in~     subjects who did not report pain at the start of the study.~   "
189343|NCT01086137|"~     The purpose of this study is to investigate the feasibility of using salivary biomarkers to~     screen for complications of metabolic syndrome including prediabetes.~   "
189344|NCT01086124|"~     The purpose of this study is to evaluate left ventricular systolic ejection fraction and~     anterior or apical akinesis 1 month and 3 months after a myocardial infarction treated with~     primary PCI to determine whether improvement at 1 month differs from improvement at 3 months.~   "
189345|NCT01086111|"~     Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep~     apnea has already been recognized in the reports on weight loss surgery.~      The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF)~     Clamp tests, the gold standard for testing IS and BCF, will be performed preoperative and~     early postoperatively.~      Aims & methodology:~      Analysis of the short-term effect of gastric bypass and sleeve gastrectomy on insulin~     sensitivity and beta cell function.~      Preoperative baseline insulin sensitivity and beta cell function will be assessed with~     euglycemic and hyperglycemic clamp tests. These results will be compared with the results of~     the same tests carried out 3 weeks postoperative.~      To determine if the duodenal exclusion is causing this effect. The results of the clamp tests~     3 weeks postoperative will be compared~   "
189346|NCT01086098|"~     Limited data exist regarding temporal trends in permanent pacemaker (PPM) implantation. To~     describe trends in incidence and comorbidities of PPM recipients, the investigators aim to~     conduct a retrospective population-based cohort study using record linkage, over a 32 year~     period.~   "
189347|NCT01086085|"~     This open-label, multi-center study will evaluate the effect on the quantitative HBsAg~     reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic~     hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of~     treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of~     treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS~     monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting~     from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.~   "
189348|NCT01086072|"~     Practice in management of myocardial ischemia and infarction has changed significantly over~     the past 20 years, both in terms of immediate management and secondary prevention.~      The aim of this observational study is to utilize the established record linkage data~     available in Tayside to investigate the trends in survivors of myocardial infarction in~     Tayside since 1994.~   "
189349|NCT01086059|"~     The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and~     unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic~     effect of these medications and to follow live born infants for one year after birth. With~     respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be~     relevant to a medication exposure during pregnancy, and these include both easily~     recognizable defects that are visible at birth, as well as, more subtle or delayed defects~     that may not be readily identifiable without special expertise and observation beyond the~     newborn period.~   "
189350|NCT01086046|"~     The purpose of this study is to evaluate blood clots after Percutaneous ASD Closure in~     different age, sexuality and defective diameter; evaluating the relationship of blood~     clotting with Occluder, injury of intima and inflammation;comparation of the effect and~     safety between different anticoagulation after Percutaneous ASD Repair; explore propose an~     optimal anticoagulation plan.~   "
189351|NCT01086033|"~     The objectives of the study are to observe and assess the long-term use, safety and efficacy~     of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and~     in accordance with the terms of the European marketing authorization and to observe~     compliance of patients with the prescribed treatment.~   "
189352|NCT01086020|"~     Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment~     for patients with coronary artery disease. Studies indicated that coronary artery plaque~     progression had positive relationship with the plasma cholesterol level, and could be halted~     or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus~     statin could further lowered blood cholesterol level. Here the investigators hypothesize that~     same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin~     plus ezetimibe could achieve the same effect on coronary artery plaque cessation or~     regression.~   "
189353|NCT01086007|"~     Previous studies have reported that about 3 % of patients who have had open inguinal~     herniorrhaphy had a visceral, ejaculatory-related pain.~      The investigators want to assess this problem among patients after laparoscopic inguinal~     hernia repair with(self-administered questionnaire study).~   "
189354|NCT01085994|"~     Sepsis is common and is associated with significant mortality, morbidity and health-care~     costs. Unfortunately, its diagnosis is not straightforward because its signs and symptoms are~     neither specific nor sensitive; in addition, microbiological cultures lack specificity,~     sensitivity and are plagued by high turn-around times. Because the delay in the institution~     of antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in~     ICU-patients, even when they are not needed. Procalcitonin may not be the long sought for~     bio-marker to establish the diagnosis of sepsis but may help decrease the duration of the~     administered antibiotic courses once they are started.~   "
189355|NCT01085981|"~     The purpose of this study is to determine if blood flow to the clitoris is increased by~     topically applying a cream that causes increased blood flow. This will be measured with a~     sonogram.~   "
189356|NCT01085968|"~     We are testing a computer game-style rehabilitation program for people with Parkinson's~     disease (PD). People with PD often have difficulty with motor planning, such as initiating or~     starting movements. We believe that our program will improve performance on a movement~     initiation task as well as on activities of daily living, such as walking, preparing a meal~     or opening a medicine bottle. We will measure brain function using functional MRI before and~     after training to identify brain areas that are involved in improved performance. If~     effective, computer based training will be an inexpensive treatment for motor planning~     deficits in PD that is free from side effects and easy to administer to a large number of~     patients.~   "
189357|NCT01085955|"~     Peri-partum cardiomyopathy is a heart muscle weakness that occurs during or following~     pregnancy. Research suggests that many initial heart injuries including viruses, pregnancy~     and other unknown causes, can lead to a process of inflammation of the heart muscle which can~     weaken the heart and cause cardiomyopathy. Why this process occurs in women during pregnancy~     is not well understood and if it differs from those women who develop cardiomyopathy from a~     virus is unknown. This study has been proposed to look at genetic information (DNA) as well~     as the immune system (the body's response to fight off infections and/or viruses) to find~     possible causes for the heart muscle damage that occurs in peripartum cardiomyopathy.~   "
189358|NCT01085942|"~     The purpose of this study is to analyze the natural course of asymptomatic rotator cuff~     tears.~   "
189359|NCT01085929|"~     The incidence of skin and soft tissue infections has increased dramatically over the last~     decade, in part due to increased prevalence of community-acquired methicillin-resistant~     Staphylococcus aureus (CA-MRSA). Incision and drainage (I&D) is considered the primary~     intervention, however some clinicians prefer ultrasound guided needle aspiration (US Asp).~     The investigators performed a randomized trial comparing US Asp to I&D for uncomplicated skin~     and soft tissue abscesses, with a subgroup analysis of patients with CA-MRSA.~   "
189360|NCT01085916|"~     The purpose of this cross-sectional survey study is to describe the prevalence of asthma and~     Rhinitis symptoms among secondary school students in Saudi Arabia.~   "
189361|NCT01085903|"~     The purpose of this study is to examine how stroke can alter arousal, alertness, neglect and~     dysphagia, and whether a medication, modafinil, can improve arousal.~   "
189362|NCT01085890|"~     The purpose of this study is to determine whether a program that includes 1) group seminars~     and 2) follow-up visits with blood pressure measurement and motivational interviewing (MI)~     that is focused on lifestyle change affect blood pressure.~   "
189363|NCT01085877|"~     This trial is conducted in Europe. The aim of this trial is to compare the absorption of~     estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two~     different production sites, in postmenopausal women with atrophic vaginitis.~   "
189364|NCT01085864|"~     A need exists for non-invasive testing to aid in clinical decision-making for Computerized~     Tomography (CT) scan detected lung nodules of indeterminate etiology. The investigators~     hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding~     clinical decisions in the setting of CT detected lung nodules to determine which nodules are~     malignant and which are benign. The investigators also hypothesize that these biomarkers will~     decrease in concentration to the normal range after successful surgical treatment of~     malignant lung nodules.~   "
189365|NCT01085851|"~     Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema,~     itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine~     formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus,~     including the ones caused by sunburn. The aim of the present study is to demonstrate~     non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1%~     lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms~     and to demonstrate the safety of both preparations.~   "
189366|NCT01085838|"~     The aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in~     high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts)~     ineligible for or having failed intensive chemotherapy and ineligible or after failure of~     treatment with a hypomethylating agent.~   "
189367|NCT01085825|"~     With sensitive urine pregnancy tests, women are now able to confirm very early pregnancies.~     However, approximately one third of abortion facilities do not offer abortions at less than~     six weeks of pregnancy. Providers may be concerned that they will be unable to identify~     products of conception (POCs) in uterine aspirates after early abortion and about the time,~     cost and risk associated with following serum hCG levels when completed abortion cannot be~     confirmed by gross inspection. Many providers believe that manual vacuum aspiration (MVA)~     causes less destruction of pregnancy tissue and therefore may increase the likelihood of~     identifying POCs on gross inspection. No published reports specifically compare MVA to~     electric vacuum aspiration (EVA) for the detection of complete products of conception and~     none compare MVA and EVA at less than 6 weeks of pregnancy. We, the investigators, propose to~     conduct a randomized controlled trial comparing the sensitivity of MVA to EVA for the~     detection of completed abortion in 500 women with pregnancies of less than 6 weeks gestation~     at a large inner city family planning center. We will measure positive identification of POCs~     on gross inspection in patients subsequently shown to have completed abortions. We~     hypothesize that the rate of true positive detection of POCs will be higher in dilation and~     curettage (D&C) using MVA than EVA.~   "
189368|NCT01085812|"~     The purpose of this study is to evaluate the safety and efficacy of F2695 sustained release~     (SR) relative to placebo in the prevention of depression relapse in patients with major~     depressive disorder (MDD).~   "
189369|NCT01085799|"~     To efficiently control soil-transmitted helminths (Ascaris, Trichuris, and hookworm), WHO,~     PAHO, and others recommend the inclusion of an education strategy in school-based deworming~     programs. However, the effectiveness of such a strategy on the rate of STH re-infection and~     on education indicators, such as absenteeism, remains to be fully understood. The proposed~     research aims to evaluate the effectiveness of a post-deworming education intervention~     targeted to Grade 5 school children enrolled in Belén's schools using a cluster-randomized~     trial design. Results will be used to inform school-based deworming programs in Peru and~     other similar endemic areas in Latin America and, indeed, around the world.~   "
189370|NCT01085786|"~     Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in~     which the first component consists of a proton pump inhibitor and amoxicillin given for 7~     days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be~     similar with the exception that the amoxicillin will be continued throughout the 14 days. The~     secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic~     resistance.~   "
189371|NCT01085773|"~     The objective of this randomized controlled trial was to evaluate the effects of two~     different physical exercise programs aimed at long-term lifestyle changes in physical~     activity in patients with Type 2 Diabetes, with glucose metabolism evaluated by HbA1c as the~     primary outcome.~   "
189372|NCT01085760|"~     The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and~     beneficial in the treatment of Primary Sclerosing Cholangitis.~   "
189373|NCT01085747|"~     Benign biliary strictures can be endoscopically treated with plastic or self-expandable metal~     stents (SEMS). The purpose of the prospective randomized study is to compare the safety and~     feasibility of covered SEMS with multiple plastic stents in the treatment of benign biliary~     stricture caused by chronic pancreatitis.~   "
189374|NCT01085734|"~     Comparative study to see if treating with Osurdex in addition to Avastin in patients with~     retinal vein occlusions helps increased visual acuity outcomes~   "
189375|NCT01085721|"~     Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during~     viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa~     more reactive to infectious agents and potentiates mucus production.~      The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits~     antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this~     product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in~     promoting mucus elimination in atopic patients with viral infections of the upper respiratory~     tract.~   "
189376|NCT01085708|"~     The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial~     condition.~   "
189377|NCT01085695|"~     The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting~     condition.~   "
189378|NCT01085682|"~     This study was conducted to test the possibility of preventing or delaying the development of~     type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma~     glucose concentrations by internet-based diabetes prevention program.~   "
189379|NCT01085669|"~     The study is conducted to analyse the infection rate in children treated with VEPTR-Implants~     for severe spine or thoracic deformities.~   "
189380|NCT01085656|"~     This study is intended to determine the safety and maximum tolerated dose of a drug, OXi4503~     (combretastatin A1 diphosphate, CA1P, OXiGENE), in patients with relapsed and refractory AML~     and MDS.~   "
189381|NCT01085643|"~     Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic~     criteria. The pathogenesis is multifactorial and gut motor dysfunction is considered to be a~     contributing factor. Changes in motor patterns in the small bowel in IBS patients are~     quantitative rather than qualitative with no distinct patterns to distinguish patients from~     healthy individuals. Changes in motor patterns can affect transit of bowel contents. Indeed,~     variation in intestinal transit was reported in patients with IBS.~      Lubiprostone is a novel agent that is Food and Drug Administration (FDA) approved for the~     treatment of chronic constipation. More recently 2 randomized double-blind,~     placebo-controlled trials showed the drug to be effective in relieving symptoms in patients~     with constipation-predominant Irritable Bowel Syndrome (C-IBS), resulting in approval for~     female patients with C-IBS at a dose of 8 micrograms twice a day.~      The investigators hypothesize that lubiprostone works not just as a laxative, but by actually~     altering motility patterns in the small intestine of female patients with C-IBS. These~     alterations can be measured through High Resolution Manometry (HRM), a new technique that~     uses catheters with multiple closely spaced sensors and special software that uses color~     schemes to portray a pressure gradient. This technique allows a detailed assessment of the~     direction and spread of contractions. The investigators would like to use HRM to see if~     lubiprostone affects intestinal contractions by giving blinded participants lubiprostone and~     placebo while they are undergoing High Resolution Manometry and seeing if any changes in~     contractions occur. Participants will be recruited from investigator's clinic. If interested,~     potential subjects will be provided with a copy of the consent form for review. Patients will~     be informed that after they have had an opportunity to review the consent form, they may~     contact the study team to further discuss the research and address any questions/concerns~     they have.~      Participants will undergo a screening visit and a manometry visit. During the screening visit~     investigators will determine eligibility, including application of inclusion/exclusion~     criteria and administration of a pregnancy test. Then during the manometry visit patients~     will receive two capsules, lubiprostone and placebo, three hours apart during HRM. Patients~     will receive each capsule only once and will not know which order they're receiving them in.~   "
189382|NCT01085630|"~     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or~     observation works in treating patients with malignant pleural mesothelioma without~     progressive disease after first-line chemotherapy.~   "
189383|NCT01085617|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells~     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. It is not yet known which regimen of combination chemotherapy given~     together with or without monoclonal antibodies is more effective in treating patients with~     newly diagnosed acute lymphoblastic leukemia.~      PURPOSE: This randomized phase III trial is studying standard chemotherapy to see how well it~     works when given together with or without rituximab, and with or without nelarabine in~     treating patients with newly diagnosed acute lymphoblastic leukemia.~   "
189384|NCT01085604|"~     The purpose of this study is to determine if trunk neuromuscular control strategies are~     changed by therapeutic exercises emphasizing core stabilization.~      Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in~     function and pain will have significantly improved trunk motor control strategies.~      Hypothesis: measures of trunk control will demonstrate 'construct-validity'. This will be~     tested using a known group method demonstrating:~        -  no significant change in motor control measures within the untreated, healthy control~          group.~        -  significant changes within the low back subjects who demonstrate clinically meaningful~          improvements.~   "
189385|NCT01085591|"~     This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel~     group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared~     with the active comparator oral vancomycin (125 milligrams (mg ) four times daily).~     Participants with diarrhea at risk for Clostridium difficile infection (CDI) [for example,~     received prior or concomitant antibiotic(s)] will be identified and tested for C. difficile~     toxin in stool using an enzyme immunoassay (EIA), or polymerase chain reaction (PCR) per the~     usual standard of care. Eligible participants will be consented, undergo baseline~     evaluations, and will be randomized in a blinded fashion to one of 3 treatment arms.~      Participants will be randomized to receive either 125 mg CB-183,315 twice daily alternating~     with placebo tablets twice daily, 250 mg CB-183,315 twice daily alternating with placebo~     tablets twice daily or 125 mg oral vancomycin four times dailyover a period of 10 days in a~     1:1:1 fashion.~   "
189386|NCT01085578|"~     Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy~     Volunteers~   "
189387|NCT01085565|"~     The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the~     safety and effectiveness of this treatment using this ExAblate conformal system in the~     treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be~     recruited in this feasibility study. The treated patients will be followed for 3-Months post~     their last treatment, patients with the standard contraindications to MRI examination, such~     as implanted metal devices (pacemakers, etc.), will be excluded.~   "
189388|NCT01085552|"~     A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy~     Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian~     Male subjects. Each subject received a single subcutaneous dose of 50IU/kg of NeoRecormon~     Multidose solution on Day 1.~   "
189389|NCT01085539|"~     Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will~     note the timing of oxygen saturation alarms, staff response, and interrupted staff~     activities.~   "
189390|NCT01085526|"~     The trial is randomized prospective study to examine the effects of subcutaneous~     immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to~     treatment or control group. The effect measures are changes in the basophil activity and~     biology as well as changes in plasma cells during and after treatment. Clinical outcome is~     assessed by QoL questionnaires and clinical testing.~      Hypotheses:~        -  changes in plasma cells correlate to changes in immunoglobulins and effector cell~          responses~        -  the reduction of inflammation due to SCIT has influence on the effector cell responses~        -  changes in paraclinical measurements can be related to clinical findings~   "
189391|NCT01085513|"~     Conventional intestinal manometry is the current gold standard for the evaluation of~     intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal~     manometry involves intestinal intubation with consequent discomfort for the patients, and~     requires considerable technical expertise and knowledge for interpretation of the data.~     Hence, to date this method has limited indications and is restricted to very few referral~     centers around the world.~      A novel method for evaluation of intestinal motility has been developed based on endoluminal~     image analysis using the endoscopic PillCam capsule, In contrast to manometry, this technique~     is minimally invasive, the technical aspects are simple, and the analysis is fully automated~     by a computer program.~      The technique has been validated in a group of patients with intestinal dysmotility and~     healthy subjects, and has demonstrated over 90% sensitivity and specificity.~      This technique needs now to be validated in a large multinational population, to further~     develop a robust discrimination algorithm for widespread diagnostic application. Furthermore,~     whereas manometry only recognizes neuropathic, myopathic and obstructive motor patterns,~     endoluminal image analysis may identify different categories of patients depending on the~     clinical presentation and the etiologic factors involved.~      This study is designed to provide evidence that the algorithm, using images created by~     PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe~     dysmotility.~   "
189412|NCT01085240|"~     The primary objective is to determine the extent to which participation in life's roles can~     be optimized through the provision of a community-based structured program providing the~     opportunity for physical activity, leisure, and social interaction.~      A secondary objective is to estimate the extent to which participation is associated with~     health benefits including health-related quality of life and reduction of unplanned~     health-care encounters for the person with stroke and reduction of burden and improvement in~     quality of life for caregivers.~   "
189392|NCT01085500|"~     Abstract: Minimally invasive techniques are now ubiquitous in the management of surgical~     disease. Competence in laparoscopy requires specialized training and practice. With the~     decrease of resident work hours, training programs need to explore and adopt efficient~     strategies to teach and evaluate laparoscopic skills. For economic, ethical, and legal~     considerations, the operating room may no longer be the ideal environment for teaching these~     basic technical skills. There appears to be a role for simulation in response to this need.~     The transfer of laparoscopic skills learned in a simulated environment to the operating room~     has showed mixed results. Overall, it seems that surgical skills training outside the~     operating room is beneficial, but the best method(s) of designing, implementing and~     evaluating such skills curriculums have yet to be identified.~      The laparoscopic totally extraperitoneal (TEP) inguinal hernia repair is an example of a~     procedure that is associated with a steep learning curve and requires mastery of basic~     laparoscopic skills. In addition, an increased recurrence and complication rates in the early~     learning curve of this procedure, underscores the importance of adequate training. The~     current practice of teaching the TEP repair in the operating room under an~     apprenticeship-based model is associated with increased operative time and costs. We propose~     that the training of surgical trainees outside the operating room with a structured, mastery~     oriented simulation-based curriculum will help reduce the learning curve of the TEP repair,~     improve operative performance, and decrease operative time and costs.~   "
189393|NCT01085487|"~     The aim of this prospective, non-interventional post-marketing surveillance study is to~     obtain data on safety and efficacy of Mirena in treatment of heavy menstrual bleeding~     (Menorrhagia) under daily-life treatment conditions.For each patient, an initial visit and~     one to three follow-up visits after about 3, 6 and 12 months will be documented by the~     treating physician on the case report form. Observations include the patient's demographic~     parameters (date of birth, height, weight, race and smoking habits), previous contraceptives~     and menorrhagia treatment, gynaecological history, baseline menstruation, result of~     insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall~     treatment success will be evaluated at the end of treatment including number of weeks until~     improvement and reduction of menstrual bleeding with respect to duration and severity, and~     patient's satisfaction.~   "
189394|NCT01085474|"~     Measurement of disease control, treatment adherence and patient knowledge of his/her~     medication in patients that are receiving a pharmaceutical intervention compared with those~     patients who receive regular pharmaceutical care.~   "
189395|NCT01085461|"~     This will be a cross-sectional study enrolling 200 outpatients/inpatients with treatment~     resistant partial epilepsy for at least two years, receiving 1-3 AEDS.~      The study will consist of one or two visits, each lasting 1-2 hours. All subjects will~     complete Visit 1. Twenty five percent of the subjects will return for Visit 2. The study will~     assess the prevalence of depression and suicidal thoughts and the feasibility of using the~     proposed psychiatric rating scales in future epilepsy clinical trials. This study will also~     provide an estimate of the proportion of patients with epilepsy (PWE) who may be ineligible~     for future trials.~   "
189396|NCT01085448|"~     The aim of this study is to determine if assessment of additional measures of trunk~     neuromuscular control will improve the ability to identify patients with low back pain who~     successfully respond to trunk stabilization exercises.~      Question: What clinical characteristics are associated with patients that respond positively~     to a program of core stabilization exercises?~      Hypothesis: Clinical characteristics that show a decrease in trunk motor control will be~     associated with a positive response to stabilization exercises.~   "
189397|NCT01085435|"~     The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to~     demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD~     System. In addition, analysis of resource utilization and costs will be performed to document~     treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts~     enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be~     included.~   "
189398|NCT01085422|"~     Assess whether the combination of ABT-888 with temozolomide (TMZ) has activity in subjects~     with metastatic castration resistant prostate cancer (CRPC) as reflected by the~     prostate-specific antigen (PSA) response.~   "
189399|NCT01085409|"~     Aim: The aim of this proposal is to investigate the potential use and value of experienced~     utility, as measured by the Experience Sampling Method and the Day Reconstruction Method, in~     the economic evaluation of health care.~      Methods: Three samples of 46 patients with different conditions one sample of 46 healthy~     controls will be included in the study. The Experience Sampling Method (ESM) and the Day~     Reconstruction Method (DRM) will be adapted and subsequently used to measure experienced~     utility. Decision utilities will be elicited by traditional preference based methods.~      Expected results: The expected results of this study are threefold. First, unified versions~     of the ESM and DRM for use in the economic evaluation of health care will be developed and~     applied. Second, a rich dataset will allow us to investigate the differences between the~     results of experienced utilities derived from these methods, with the traditional preference~     based measures. Third, the normative implications of the use of QALYs based on either~     decision utilities, experienced utilities, or a combination of the two, for health care~     resource allocation decisions, will be examined.~      Keywords: experienced utility, decision utility, subjective well-being, experience sampling~     method, day reconstruction method~   "
189400|NCT01085396|"~     This study is designed to collect information about melanoma using a research probe, a device~     placed only on the skin. This study will investigate whether using the probe to examine skin~     lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to~     predict the risk melanoma in the skin of subjects. Ultimately, we would see this technique~     used routinely as a non-invasive device during subjects' skin examination to aid~     dermatologists to identify pre-cancerous (melanoma) lesions without taking tissue samples of~     the skin. Alternatively, this technique would, in the future, also be used to screen patients~     at risk for melanoma.~   "
189492|NCT01084200|"~     Postoperative pain may be affected by general anaesthetics. The effect of propofol and~     sevoflurane on postoperative pain in chinese female patients has not been demonstrated~     before. This study compared the postoperative pain score in patients under general~     anaesthesia maintained with propofol,sevoflurane, or sevoflurane+propofol.~   "
189401|NCT01085383|"~     Antipsychotic medicines are used routinely in people with severe mental illness or learning~     disability. Antipsychotics often induce hyperprolactinemia (high prolactin level) and in~     almost all women, and some men, this causes hypogonadism (impaired ovarian or testicular~     function)often with osteoporosis, partly explaining psychiatric patients' high fracture risk.~     Reducing prolactin by changing antipsychotic or adding a dopamine agonist often worsens~     psychosis. Adding aripiprazole to current antipsychotic normalizes prolactin in adult~     schizophrenic patients, without serious side effects. We thus plan a study of add-on~     aripiprazole in people with antipsychotic induced hyperprolactinemia.~      Our main hypothesis is that aripiprazole will normalize or reduce prolactin sufficiently to~     restore normal ovarian and testicular function. Our secondary hypothesis is that restoration~     of normal ovarian and testicular function will improve bone mineral density in patients in~     whom this was reduced at the time of entry into the study.~   "
189402|NCT01085370|"~     Within a randomized controlled design the effects of a brief early psychological intervention~     (child, parents) after road traffic accidents or burns shall be examined in a sample of 120~     children and adolescents (aged 2 to 16 years). During the first seven days after the accident~     a screening for the risk of developing a posttraumatic stress disorder is conducted to divide~     the participants into a high risk and a low risk group. Participants with a low risk are~     excluded from the intervention study but reassessed six months after their accident to~     validate the screening instrument. After a baseline assessment within 14 days after the~     accident participants of the high risk group are randomly assigned to an intervention group~     (n = 60) or a control group (n = 60). The latter receive standard medical care. Children of~     the intervention group are provided with a brief age appropriate two-session intervention~     that includes a detailed reconstruction of the accident, psychoeducation and discussion of~     helpful coping strategies. Both the control and the intervention group are reassessed by~     blind raters at 3 and 6 months after the accident. Assessment of outcome includes measures of~     posttraumatic stress symptoms, depression, anxiety, behavior, and health-related quality of~     life.~   "
189403|NCT01085357|"~     The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for~     lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.~   "
189404|NCT01085344|"~     Primary prophylaxis given less frequently initially, with the infusion frequency increased if~     needed (Escalating Dose Prophylaxis), is likely to be less expensive and associated with~     fewer complications than standard prophylaxis while reducing disability to a greater degree~     than intermittent therapy.~   "
189405|NCT01085331|"~     The research trial is testing the experimental treatment pimasertib (MSC1936369B) in~     combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal~     cancer subjects. The study will be run in two parts:~      Part 1, or Safety Run-in Part: Will determine the maximum tolerated dose and the recommended~     Phase 2 dose (RP2D) of pimasertib combined with FOLFIRI as second-line treatment in subjects~     with metastatic K Ras mutated colorectal cancer.~      Part 2 or Phase 2 Randomised Part: Will assess the anti-tumor activity of pimasertib combined~     with FOLFIRI compared to FOLFIRI with placebo as second-line treatment in metastatic K Ras~     mutated colorectal cancer subjects.~      Phase I which Is an open label dose escalation 3+3 cohort, non-randomized, safety Phase II~     which is a double blind randomized safety/efficacy~   "
189406|NCT01085318|"~     The purpose of this trial is to evaluate the effects of Rebif® 44 mcg subcutaneous (sc) three~     times a week (tiw) on a) remyelination/demyelination, b) lesion and brain volume, c) central~     nervous system (CNS) iron deposition, and d) immune status in subjects with~     relapsing-remitting multiple sclerosis (RRMS) RRMS via several MRI techniques.~   "
189407|NCT01085305|"~     The purpose of this study was to investigate whether a type of parent-based intervention,~     Parent-Child Interaction Therapy will lower symptoms of behavior problems in young children~     more than treatment as usual.~   "
189408|NCT01085292|"~     The primary objective of this trial is to evaluate the safety and tolerability of multiple~     intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus.~     A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic~     response at the level of inflammation, metabolism as well as ongoing diabetes complications~     (e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to~     provide sufficient safety and dose-response data for a planned Phase IIa proof of concept~     study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.~   "
189409|NCT01085279|"~     The purpose of this study is to determine whether the use of non-ablative fractional laser is~     safe and effective in the treatment of melasma.~   "
189410|NCT01085266|"~     An open-label extension study of the HORIZON protocol evaluating the safety of dimebon~     (latrepirdine)in subjects with Huntington disease.~   "
189411|NCT01085253|"~     To date except for the larger striato-pallidal complex, there are no reliable imaging markers~     of small deep nuclei. Major improvement of the spatial resolution resulting from the use of~     ultra-high field MRI systems offers new perspectives of imaging of these deep structures.~      We will use the new contrast mechanisms available in data acquired with ultra-high field MR~     systems (7T) as well as the most recent high angular diffusion imaging techniques in order to~     characterize the cytoarchitectonics of the deep brain structures and brainstem lesions in~     parkinsonian syndromes (with special interest in substantia nigra (SN) pathology and~     nigro-striatal fiber pathways; subthalamic nucleus (STN), red nucleus (RN), oculomotor~     structures (involved in PSP); pedonculo-pontine nucleus (involved in gait and posture control~     disorders) and the locus sub-coeruleus area (implicated in sleep disorders) The optimized MR~     sequences at 7T will be adapted and validated at 3T (on a more clinically oriented MRI~     approach).~      The clinical goal of the project (via the characterization of deep brain structures) is the~     detection of new neuroimaging markers of neuronal lesions in PD. These biomarkers will be~     used to create a diagnostic tool at early stage of the disease that could be correlated to~     clinical signs such as gait disorders and help to identify predictive factors. In addition,~     this could contribute to establish an adequate therapeutic strategy (as for example with deep~     brain stimulation).~   "
189493|NCT01084187|"~     The purpose of the study is to assess the correlation of FMD of brachial artery and carotid~     intima media thickness with ED severity and clinical response to vardenafil in hypertensive~     men.~   "
189413|NCT01085227|"~     Besides Parkinson's disease (PD), it exists rare parkinsonian syndromes clinically close to~     PD and that correspond to Mendelian entities. Autosomal dominant forms are mainly associated~     with mutations of alpha synuclein and LRRK2/dardarin genes, whereas autosomal recessive forms~     are due to mutations in Parkin, Pink1 and DJ-1 genes. This entities are still unknown on the~     clinical, genetic and metabolic  au plan .~      Throughout a national network of 15 specialized centres in movement disorders, coordinated by~     the team of the neurogenetics reference centre at the Pitié-Salpêtrière Hospital (Alexis~     Brice), we propose to precise the relative frequency, the molecular bases and abnormalities~     in functional neuroimaging associated with the LRRK2 gene mutations, the most frequently~     implicated in the autosomal dominant forms. Due to the relative rarity of this parkinsonian~     syndrome, we will perform at the same time a retrospective study in cases and families~     already collected by the national network (300 isolated cases and 300 families) and a~     prospective study. The network will recruit 100 isolated cases and 40 familial cases yearly,~     with precise diagnosis tools. The genetic analysis will evaluate the relative frequency of~     the LRRK2 mutations and their spectrum in the French population. Phenotype-genotype~     correlations will be performed to better orientate the molecular diagnosis, in order to~     improve the genetic counselling and reduce costs of these analyses. In the case of LRRK2~     mutations, a genetic investigation will be proposed to the families, with a specific care to~     at-risk cases. A detailed phenotypic evaluation of patients and at-risk cases will be~     proposed (neurological, neuropsychiatric and behavioural) at the CIC Pitié-Salpêtrière and~     also in imaging, for 15 patients and 40 of their relatives (20 carriers and 20 non-carriers~     of the LRRK2 mutation). The TEP study will evaluate the dopaminergic function (fluorodopa~     capture) and will measure the dopamine transporter (DAT). The structural MRI evaluation will~     search for possible associated structural morphologic abnormalities. The functional MRI~     evaluation will search for dysfunction of motor circuit during the movement realisation.~     These examinations will be performed at two years of interval for appreciate the evolution of~     the disease. This study will allow to better characterize the parkinsonian syndromes due to~     LRRK2 mutations and also to better characterize the presymptomatic phase, which is subject to~     controversies in idiopathic PD. The feasibility of this project is assured by the expertise~     of the collaborative centres and by the inclusion of a retrospective cohort, combined to a~     prospective cohort, which will allow to recruit sufficient patients and at-risk relatives for~     a rare genetic entity.~   "
189414|NCT01085214|"~     This phase II trial studies how well selumetinib works in treating patients with multiple~     myeloma, a type of cancer in which a specific protein is over active. Selumetinib may stop~     the growth of cancer cells by blocking this protein.~   "
189415|NCT01085201|"~     Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to~     change their shape from a round shape to a half-moon/crescent or sickled shape. People who~     have SCD have a different type of protein that carries oxygen in their blood (hemoglobin)~     then people without SCD. This different type of hemoglobin makes the red blood cells change~     into a crescent shape under certain conditions. Sickle-shaped cells are a problem because~     they often get stuck in blood vessels blocking the flow of blood, and cause inflammation and~     injury to the important areas in the body. Lexiscan is drug that may prevent this~     inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA~     to be used as a fast infusion during a heart stress test in people who are unable to exercise~     enough to put stress on their heart by making it beat faster. Lexiscan has never been studied~     in patients with SCD and has never been given as a long infusion.~   "
189416|NCT01085188|"~     Following discharge from residential treatment 324 adolescents are randomly assigned to~     Assertive Continuing Care with and without motivational incentives in a 2 x 2 factorial~     design. Clinical outcomes are assessed at 3, 6, 9, and 12 months post discharge.~   "
189417|NCT01085175|"~     The purpose of this clinical study is to determine the optimal imaging parameters and assess~     the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.~   "
189418|NCT01085162|"~     This long-term study will follow patients with known or suspected of having coronary artery~     disease (CAD) and have participated in present and future BMS747158 clinical studies. The~     purpose of this study is to evaluate the long-term predictive value associated with BMS747158~     Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI).~   "
189419|NCT01085149|"~     Simvastatin has been reported to promote osteoblastic activity and inhibit osteoclastic~     activity by enhancing the expression of BMP2. There have been many studies demonstrating the~     bone-promoting effect of local application various animal models including after application~     into socket of teeth in a rat. the purpose of the study is to investigate the effect of slow~     release topical simvastatin in socket of mandibular teeth on bone remodeling in the socket~   "
189420|NCT01085136|"~     The primary objective of this randomized, open-label, active-controlled, multi-center trial~     is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with~     NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone~     in this patient population. Patients on both treatment arms will receive best supportive care~     in addition to study treatment. Patients enrolled into the trial will be treated and followed~     until death or lost to follow-up. Additional information on the health-related quality of~     life (HRQOL) will be collected.~   "
189421|NCT01085123|"~     The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG®~     Rapimelt (zolmitriptan) in healthy male volunteers.~   "
189422|NCT01085110|"~     Describe and characterizes laparoscopic postherniotomy patients with persistent~     moderate/severe pain affecting every day activities - including detailed quantitative sensory~     assessment~   "
189423|NCT01085097|"~     The study aims to evaluate the safety and clinical effect of daily oral treatment with~     laquinimod capsules in active lupus nephritis patients. This study will assess Laquinimod~     doses of 0.5mg /day and 1 mg/day in combination with standard of care treatment~     (mycophenolate mofetil and corticosteroids). Laquinimod is a novel immunomodulating drug~     which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for~     Multiple Sclerosis.~   "
189424|NCT01085084|"~     The study aims to evaluate the safety and clinical effect of daily oral treatment with~     laquinimod capsules (0.5mg /day and 1mg /day) in active lupus arthritis patients. Laquinimod~     is a novel immunomodulating drug which is currently in advanced stages of development by Teva~     Pharmaceuticals Ltd. For Multiple Sclerosis.~   "
189436|NCT01084928|"~     The South Asian Community, people with origins in India, Pakistan, Bangladesh, Maldives,~     Nepal, Sri Lanka, or Bhutan, are more likely to get diabetes, get diabetes at younger ages,~     and do worse health-wise once they have diabetes than the general population. This study will~     test the feasibility and community acceptability of a culturally appropriate lifestyle~     intervention for the prevention of diabetes in the South Asian community. The outcomes of~     this project could be used to plan larger interventions to prevent diabetes in South Asians,~     a rapidly growing segment of the US population.~   "
189494|NCT01084174|"~     The purpose of this study is to explore the safety and efficacy of a sublingual (under the~     tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in~     inducing desensitization and long term tolerance in children with persistent peanut allergy.~   "
189495|NCT01084161|"~     To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539~     in subjects undergoing open abdominal hysterectomy~   "
189425|NCT01085071|"~     Rationale: It is well known that distinctly abnormal blood potassium values can cause serious~     complications such as cardiac arrhythmias. Although potassium regulation is generally~     considered important, hardly any research has been done about potassium regulation in~     intensive care patients. The investigators hypothesize that different potassium~     target-values, within the as normal accepted range, may have different effects in critically~     ill patients.~      Study design: A prospective trial comparing two different potassium target-values. Potassium~     will be tightly regulated with the already fully operational GRIP-II computer program.~      Study population: 1200 adult patients admitted at the thoracic intensive care unit of the~     University Medical Center Groningen.~      Intervention: Comparison between two variations of standard therapy: potassium target-value~     of 4.0 mmol/L versus 4.5 mmol/L.~      Main study parameters/endpoints: The primary endpoint is the incidence of atrial fibrillation~     or atrial flutter from ICU-admission to hospital discharge. Secondary endpoints are serum~     levels of potassium and the other main electrolytes, renal function and renal potassium~     excretion, the relation with insulin and glucose, the cumulative fluid balance, (ICU) length~     of stay and mortality.~   "
189426|NCT01085058|"~     This investigator initiated trial was a prospective, open, single-arm, diagnostic-prognostic~     study. Patients who received high-dose therapy with autologous stem cell transplantation for~     the treatment of their lymphoproliferative disease were included into the study.~      After completion of the high-dose therapy (day -2 with respect to the stem cell~     transplantation) the first blood sample A for the cytocapacity test with determination of~     leukocytes and neutrophils was taken in the evening of day -1. Directly thereafter the study~     medication was administered. The second blood sample B for the cytocapacity test with~     determination of leukocytes and neutrophils was taken in the morning of day 0, 12-14 hours~     after administration of the study medication. Thereafter the stem cell re-infusion was~     performed.~      The primary objective of this study was to show that the cytocapacity test with lenograstim~     is a useful predictive tool with respect to the risk of post-transplant complications and~     prolonged myelosuppression, typically occurring after high-dose chemotherapy.~      The primary variables were:~        -  the rate of patients with documented infections~        -  the time to platelet engraftment~   "
189427|NCT01085045|"~     The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of~     PT003 compared with its individual components (PT001 and PT005), placebo and two active~     comparators to demonstrate superiority of the combination to its components, and to assess~     the relative contribution of the components compared with placebo, in patients with moderate~     to very severe COPD.~   "
189428|NCT01085032|"~     The study is a two-arm, parallel group, randomized, placebo-controlled, double blind trial,~     conducted at four primary health care centers in Aleppo, Syria, to test the efficacy of~     transdermal nicotine patch therapy vs. placebo patch therapy, when delivered with behavioral~     counseling, on smoking cessation rates.~   "
189429|NCT01085019|"~     The general objective of the study is to investigate the effects of the daily consumption of~     spices and herbs for four (4) consecutive weeks in endothelial function and cardiovascular~     risk factors of men and postmenopausal women.~   "
189430|NCT01085006|"~     Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean~     delivery in a double blind randomized placebo controlled trial.~   "
189431|NCT01084993|"~     RATIONALE:~      Transradial coronary stenting is associated with less risk of access site complications and~     bleeding compared to femoral approach.~      Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of~     the antithrombotic regimen and access-site used, bleeding related to access-site represents~     50-80% of the cases. Whereas transradial approach minimizes the risks of access-site~     bleeding, it has no impact on non-access site bleeding.~      Peri-procedural anemia is also an independent predictor of mortality and MACE.~      With femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been~     associated with a significant reduction in access-site and non-access site related bleeding.~      In a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a~     trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ±~     glycoproteins IIb-IIIa.~      HYPOTHESES:~      In patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa~     reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa.~      In patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin~     significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.~   "
189432|NCT01084980|"~     The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with~     minimal change nephritic syndrome.~   "
189433|NCT01084967|"~     The purpose of this study is to explore the pathogenesis and genetic susceptibility of obese~     subjects,providing a convincing argument for further treatment of obesity and metabolic~     syndrome.~   "
189434|NCT01084954|"~     Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop~     a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection.~     Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent~     amplification or the Cepheid Xpert HIV-1 Quant Assay. A false negative or false positive rate~     of >1.0% would make this test unacceptable as a screening test for HIV viremia.~   "
189435|NCT01084941|"~     The prevalence of overweight and obesity is increasing among pregnant women in the United~     States. More than one-third of women of reproductive age in the US are overweight or obese,~     and two thirds of women gain more weight in pregnancy than is recommended by the Institute of~     Medicine guidelines. Maternal obesity during pregnancy increases the risk of complications to~     both mother and child. Minority women (Blacks and Hispanics) have higher rates of overweight~     and obesity when they become pregnant, experience higher rates of excessive weight gain~     during pregnancy, and experience higher rates of maternal and neonatal complications after~     adjusting for sociodemographic characteristics and comorbidities than Caucasian women.~     Epidemiologic studies indicate that lifestyle modification programs based on diet and~     exercise are promising approaches in controlling weight gain as well as in preventing type 2~     diabetes in populations at risk. We hypothesize that overweight/obese minority women (Blacks~     and Hispanics) assigned to a culturally-grounded lifestyle intervention program based on diet~     and moderate exercise will result in higher compliance with Institute of Medicine guidelines~     for weight gain than women receiving standard care. Such lifestyle modifications should~     reduce risk of maternal and neonatal complications. We propose 1) to determine whether a~     lifestyle intervention program, based on diet and moderate physical activity implemented~     shortly after first recognition of pregnancy, will result in higher compliance with Institute~     of Medicine guidelines for weight gain compared to women receiving standard care; 2) to~     determine the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation (after~     the first 10-12 weeks of intervention) and at 6 weeks postpartum between women in the~     lifestyle intervention group and women receiving standard care; and 3) to explore the impact~     of the lifestyle intervention on the development of maternal and fetal complications during~     pregnancy. By limiting excessive weight gain, the lifestyle intervention program may prevent~     the burden of obesity-related complications during pregnancy and reduce risk of subsequently~     developing overt diabetes.~   "
189437|NCT01084915|"~     Since a few years the SAGB-VC is used in our clinic. This type of band has a number of~     advantages when compared to the earlier versions of the adjustable gastric band (AGB),~     reducing the chances on leakage, tube disconnection and port problems. In our clinic the~     follow up is strict. All patients are required to follow a special follow-up program in which~     the patient is seen 19 times during the first two years after SAGB-VC placement.~      This is the first retrospective clinical study of a large study population of >800 patients~     in which a SAGB-VC was placed. This study was conducted to evaluate the results and the~     efficiency of the SAGB-VC in our clinic.~   "
189438|NCT01084902|"~     Prostaglandin analogs (PGAs) represent a new class of active ocular hypotensive agents and~     possess a unique mechanism of action. Many studies suggested that 0.005% Latanoprost was more~     effective and safer than other anti-glaucoma medications, such as beta-blockers. It has also~     been found to be more effective than other class of anti-glaucoma medications such as~     carbonic anhydrase inhibitors and alpha agonists. However data on such comparison is lacking~     in Chinese patients. So it is necessary to increase China experience and get clinical data~     from China. Besides latanoprost, brinzolamide is known as one of the other ocular hypotensive~     agents with less systemic adverse effects, therefore it is selected as the controlled~     medication of this study. The administration phase will be 4 weeks because it is long enough~     to compare both efficacy and safety of the study drugs and accounting for following-up~     conditions in China, it will be easier for the investigators to get enough subjects in a~     limited stage if the observation time is shorter.~      Before treatment with the study drugs, any previous glaucoma drugs will be washed out. The~     minimum washout periods are 5 days for cholinergic agonists, 1 week for adrenergic agonists,~     3 weeks for adrenergic β receptor blockers and 4 weeks for PGAS. After washout, the patients~     will be randomised send to two parallel study groups: one group will receive latanoprost~     0.005% once daily in the evening, the other group receive 1.0% Brinzolamide twice daily.~     Randomization will be obtained using a list of random numbers .During the study there will be~     four visits: screening, baseline, 2 weeks, and 4 weeks of treatment. The IOP will be measured~     with a Goldmann tonometer at 8 am for each visit. The tonometry will be performed before the~     administration of the dose of the day in patients treated with Brinzolamide. Three separate~     measurements will be taken for each eye and the mean of the three measurements will be used~     in the statistical analysis. Best corrected visual acuity and refraction will be determined~     and a slit lamp examination, ophthalmoscopy will be performed at all visits.~   "
189439|NCT01084889|"~     The purpose of this study is to determine the influence of Anterior Pelvic Prolapse~     Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of~     live.~   "
189440|NCT01084876|"~     The purpose of the study is to to demonstrate equivalence~   "
189441|NCT01084863|"~     The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)~   "
189442|NCT01084850|"~     The purpose of this study is to compare corneal endothelium morphology and central thickness~     in type II Diabetes Mellitus and normal subjects with special reference to glycemic status.~   "
189443|NCT01084837|"~     Primary outcome measure:~        -  Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone~          treatment~      Secondary outcome measures:~        -  Study the speed of response and the response rate (M component in serum and urine~          protein) after each bortezomib/dexamethasone cycle~        -  Compare the efficacy of the bortezomib/dexamethasone therapy against the therapy without~          bortezomib~        -  Reversibility of renal failure~        -  Predictive value in the light chain determination for response and reversibility of~          renal failure~        -  Early morbidity (< 2 months)~        -  Progression-free survival~        -  Overall survival~      The safety outcome consists in:~        -  Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity~          criteria of clinical and laboratory events~   "
189444|NCT01084824|"~     The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts,~     is more effective if it is used alone, or if it is more effective if combined with~     cantharidin, a topical treatment also commonly used for warts (verruca vulgaris).~   "
189445|NCT01084811|"~     The investigators will conduct a descriptive, prospective, three-armed study concerning the~     pathophysiology of chronic rhinosinusitis.~      In one part of the study the investigators want to investigate the presence of biofilm in~     patients with chronic rhinosinusitis both with and without nasal polyps compared with a~     control group of subjects without chronic rhinosinusitis. The investigators will also compare~     quality of life in the three groups and correlate disease severity in biofilm patients versus~     patients where biofilm was not present.~      The hypothesis here is that biofilm patients suffers a more severe disease.~      In the other arm of the study the investigators will compare the presence of different~     biochemical compounds in the three study groups. The investigators specifically want to~     investigate matrix metalloproteases and apoptosis-inhibitors with immunohistochemistry. The~     investigators may also add other compounds to our test-battery if interesting candidates~     surface in the literature during the inclusion period.~      The purpose of this part of the study is to investigate candidates for the development of~     nasal polyposis.~      The investigators plan to include 100 patients suffering from chronic rhinosinusitis with~     nasal polyps, and 100 patients with chronic rhinosinusitis without nasal polyps and 30~     control subjects.~   "
189446|NCT01084798|"~     This is an observational, non comparative, non-randomised, open-label, retrospective, single~     centre study planned to collect the data of subjects diagnosed with multiple sclerosis (MS)~     as per Poser or McDonald criteria between 1997 and 2007 in Taiwan. The clinical features and~     annual relapse rate in the first five years after the onset of disease have been compared~     between conventional and optico-spinal MS in the earlier studies. This study aims to~     understand the clinical care pathway of MS subjects and facilitate the subject's diagnosis~     before converting to MS.~   "
189447|NCT01084785|"~     The purpose of this study is to determine, by means of DNA and protein analysis, the~     relationship between DNA and protein profiles and a number of endpoints, which are important~     for the patient such as overall survival and side effects.~   "
189448|NCT01084772|"~     The objective of this study is to assess outcomes following TKA, utilizing two surgical~     techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation~     and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at~     preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary~     objective of this study is to compare the safety, quality of life, and economic outcomes of~     TKA when these two techniques are utilized. This study does not involve treatment or~     investigational products, as all components are FDA cleared and are commercially available.~   "
189478|NCT01084382|"~     Early interests in Arthrospira p. (Spirulina) were based on its high source of protein.~     Recently, it has drawn attention for its therapeutic effects including anticancer properties,~     antiviral and antibacterial properties as well as improvement of the immune system.~      The aim of this study is to investigate the effect of a daily supplementation with Spirulina~     for adult wife living with HIV/AIDS in Yaoundé.~   "
189449|NCT01084759|"~     The objective of the study is to determine if men with evidence of progressive prostate~     cancer while on chronic androgen ablation of ≥ 1 year duration will exhibit a clinical~     response following administration of parenteral testosterone and oral etoposide.~      Treatment Plan: Eligible patients will continue on androgen ablative therapy with luteinizing~     hormone-releasing hormone (LHRH) agonist (i.e. Zoladex or Lupron) if not surgically~     castrated. Patients will receive intramuscular injection with testosterone cypionate at a~     dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy). This dose~     was selected based on data demonstrating that it produces an initial supraphysiologic serum~     level of testosterone (i.e. > 3-5 times normal level) with eugonadal levels achieved at the~     end of two weeks. Beginning the day of the testosterone injection, patients will also receive~     oral etoposide 100 mg/day in divided doses (50 mg q 12h) x 14 days out of 28 days per cycle.~     After 3 months on therapy, patients will have repeat prostate specific antigen (PSA) and~     bone/computed tomography (CT) scans to establish the effect of combined testosterone and~     etoposide treatment on these parameters (i.e. testosterone effect baseline). Patients with~     sustained elevations in PSA ≥ 50% above pre-testosterone treatment PSA levels after the~     initial three months of testosterone and etoposide therapy will not receive continued therapy~     and will come off study. Patients with PSA levels less than the peak serum PSA level seen~     over the three month period (PSA decline) or patients with PSA ≤ 50% of pretreatment baseline~     will receive a second 3 month course of monthly testosterone and etoposide therapy until~     evidence of disease progression. Disease progression is defined as a PSA increase above the~     PSA level obtained after 3 months on testosterone treatment over two successive measurements~     2 weeks apart or evidence of new lesions or progression on bone/CT scans compared to baseline~     studies. Patients who respond to initial treatment with testosterone and etoposide and then~     show signs of progression will have the option of retreatment with testosterone alone after a~     period of 3 months or greater off of the original therapy.~   "
189450|NCT01084746|"~     The primary goal of this research project is to conduct a 5-year prospective randomized trial~     of a theory-based intervention to increase patient completion of colorectal cancer screening~     (CRCS) among patients ages 50 to 64 years old.~   "
189451|NCT01084733|"~     The objective of this study is to evaluate the relationship between serum nicotine levels and~     tumor response of squamous cell cancers of the head and neck (SCCHN) to radiotherapy alone or~     in combination with chemotherapy.~      Correlation of RECIST response, volumatic response, pathologic response (in patients~     receiving post-treatment neck dissection), and hemodynamic response (tumor oxygenation and~     blood flow) will be performed.~   "
189452|NCT01084720|"~     -  To evaluate the palliative effects of a moisturising emollient, in patients with uremic~          xerosis of moderate, severe or very severe intensity, associated or not to uremic~          pruritus.~        -  To assess the local tolerance of the test product and its vehicle, and to evaluate the~          overall agreement (efficacy, tolerance easiness of use) of the patients for the test~          product.~   "
189453|NCT01084707|"~     A comparison of three products for oral nicotine replacement with respect to pharmacokinetics~     after multiple-doses of nicotine.~   "
189454|NCT01084694|"~     The purpose of this study is to examine the impact that serving as a caregiver for a patient~     undergoing hematopoietic stem cell transplant has on the caregiver. This will include looking~     at the caregiver's level of burden, depression, anxiety, somatic symptoms, fatigue and~     overall distress. It will also look at whether caregiver burden leads to an increase in~     hospitalization and overall outcome.~   "
189455|NCT01084681|"~     To date the standard non-surgical treatment strategy for treating un-ruptured intracranial~     aneurysms is the use of either coils or self-expandable stents. This post-market clinical~     investigation compares the efficacy of using the CE-marked, commercially available SILK~     Artery Reconstruction Device against commercially available intracranial coils in the~     endovascular treatment (occlusion) of intracranial aneurysms.~   "
189456|NCT01084668|"~     The aim of this post-marketing observational study (PMOS) was to obtain further data on~     long-term safety, efficacy, and quality of life outcomes for adalimumab in routine clinical~     use in participants with moderate to severe chronic plaque psoriasis after unsustainable~     clinical response to other biologic disease modifying anti-rheumatic drugs (BDMARDs). There~     are few data so far showing the effects of switching from other BDMARDs to adalimumab in~     patients with moderate to severe chronic plaque psoriasis. This study was designed to~     evaluate the long-term effectiveness of adalimumab in participants with moderate to severe~     chronic plaque psoriasis using the Psoriasis Area and Severity Index (PASI) in participants~     previously treated with efalizumab, infliximab, or etanercept and who either never achieved~     satisfactory response, achieved satisfactory response initially but lost it over time, or~     discontinued treatment due to intolerance/side effect(s) or other reasons, for example after~     regular stop of etanercept.~   "
189457|NCT01084655|"~     This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel~     and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and~     will allow estimation of prostate-specific antigen (PSA) response in men with metastatic~     castration-resistant prostate cancer (mCRPC).~   "
189458|NCT01084642|"~     The purpose of this study is to survey female cancer patients' awareness of and preference~     for methods to improve sexual health. This information will help to improve our understanding~     of the needs and preferences for sexual health strategies and interventions of our female~     patients.~      The findings of this survey will also be used to develop feasible sexual health resources for~     our patients and enhance the success of grant proposals to support future sexual health~     interventions at MSKCC.~   "
189459|NCT01084629|"~     The purpose of this study to assess post ablation, if there are areas of Barrett's mucosa~     post ablation and to assess the ability of the Fujinon FICE system to detect this, as~     compared to white light endoscopy. A subgroup will also be compared with laser confocal~     microscopy~   "
189460|NCT01084616|"~     It is known that vaginal bacteria have an impact upon the health status of the host, in some~     cases protecting against infection and in other cases causing infection, depending on the~     bacterial types present. This study will compare the composition of vaginal bacteria to~     symptoms of vaginal dryness in order to try and identify if certain bacteria might cause some~     of the problems associated with vaginal dryness among post-menopausal women.~   "
189461|NCT01084603|"~     A comparison of three products for oral nicotine replacement with respect to pharmacokinetics~     after single-dose of nicotine.~   "
189489|NCT01084239|"~     The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs)~     across the U.S. expands the opportunities for its clinical application, but also heightens~     the need to define its appropriate use in the evaluation of patients with acute chest pain.~     To address this need, we performed a randomized diagnostic trial (RDT) to determine whether~     integrating cardiac CT, along with the information it provides on coronary artery disease~     (CAD) and left ventricular (LV) function, can improve the efficiency of the management of~     these patients (i.e. shorten length of hospital stay, increase direct discharge rates from~     the ED, decreasing healthcare costs and improving cost effectiveness while being safe).~   "
189462|NCT01084590|"~     The pediatric primary care setting is a relatively untapped resource for addressing obesity~     prevention. The main goal of this study is to evaluate the efficacy of a relatively low cost~     pediatric primary-care based obesity prevention intervention. The intervention will consist~     of brief pediatrician counseling as well as phone coaching for parents with overweight~     children who are between the ages of five and nine. We propose to enroll and randomize 425~     parent-child dyads with children who have a measured body mass index (BMI) the 75th and 95th~     percentile. They will be randomized one of into two groups, the (a) Healthy Eating/Physical~     Activity Intervention, or the (b) General Healthy/Safety/Injury Prevention Contact Control~     Intervention. Both groups will receive brief pediatrician counseling regarding their child's~     current BMI percentile status and recommendations for home environmental changes to achieve a~     healthy weight gain trajectory and to improve home safety and reduce injury risk. This will~     be paired with a 12 month home-based program delivered via phone by health behavior~     specialists to help parents make environmental changes specific to their group assignment.~   "
189463|NCT01084577|"~     A prospective, comparative, randomised study to compare the effects on ulcer healing of~     AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to~     Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.~   "
189464|NCT01084564|"~     Cost effectiveness analysis of local management of patients diagnosed with heart failure~     disease compared with an ideal guideline-based management.~   "
189465|NCT01084551|"~     The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in~     patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg~     during a 13-week dose-titration and maintenance period. This is a multi-center, randomized,~     placebo-controlled, double-blind, 3-armed parallel group comparison study.~      Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of~     the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale~     (IRLS) total score from baseline to the end of the dose-maintenance period.~   "
189466|NCT01084538|"~     This is the post-marketing study conducted in two countries: Croatia and Serbia. In both~     countries Zemplar (paricalcitol) is the first injectable form of any Vitamin D Receptor (VDR)~     activator available for chronic kidney disease patients on hemodialysis. The evaluation of~     outcomes of VDR activator treatments in clinical practice is a major challenge in the~     management of this patient population. The aim of this post-marketing observational study is~     to obtain further data on the outcomes of Zemplar Injection administration during routine~     clinical use.~   "
189467|NCT01084525|"~     The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral~     Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease~     will also be evaluated.~   "
189468|NCT01084512|"~     Objective: To investigate the movement strategy of breathing based on three-compartment model~     measured by optoelectronic plethysmography (OEP) and electromyography (EMG ) among~     individuals with and without spinal cord injury in supine posture during deep inspiration.~      Design: cross sectional repeated-measure with age matched control group. Setting: Motion~     Analysis Laboratory Participants: Seven tetraplegic and five paraplegic subjects and twelve~     age matched healthy controls were recruited.~      Intervention: Not applicable.~   "
189469|NCT01084499|"~     Bioequivalence~   "
189470|NCT01084486|"~     Abstract~      Background: Insulin resistance has an important role in the development of nonalcoholic fatty~     liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and~     atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a~     favorable effect towards hepatic steatosis and cardiovascular outcomes.~      Objectives: The present study investigated the effect of metformin on arterial properties,~     metabolic parameters and liver function in patients with NAFLD. Methods In randomized,~     placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1~     received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and~     augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney,~     Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and~     serum adiponectin levels were determined.~   "
189471|NCT01084473|"~     The aim of the study is to determine the effect of dexmedetomidine infusion on gastric~     emptying and oro-caecal transit time in healthy volunteers, judged by measuring plasma~     paracetamol concentrations after paracetamol ingestion and pulmonary hydrogen measurement~     technique after lactulose ingestion. The effects of dexmedetomidine will be compared to the~     effects of morphine and placebo.~   "
189472|NCT01084460|"~     Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up~     conservatively. However, little is known about the natural course of small GISTs. The goal of~     this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and~     to determine the size predicting subsequent progression with increased malignant potential.~   "
189473|NCT01084447|"~     The purpose of this study is to assess the effect of post-operative inspiratory muscle~     training on muscle strength and endurance in patients with obesity submitted to gastroplasty.~   "
189474|NCT01084434|"~     The aim of the study is to investigate the effect of dietary supplements such as probiotic,~     prebiotic and synbiotic on the immune response to influenza vaccination and faecal microbiota~     in adult healthy volunteers.~   "
189475|NCT01084421|"~     The purpose of this study is to examine the efficacy of a brief culturally appropriate and~     theory-based parental communication intervention designed to improve parent-adolescent sexual~     communication and reduce adolescent sexual risk behavior.~   "
189476|NCT01084408|"~     The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please~     angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a~     drug eluting stent.~   "
189477|NCT01084395|"~     The broad objective of this project is to test the efficacy of a theory-based HIV~     risk-reduction intervention, which includes both an adolescent component and parental~     component, designed to reduce the adolescents' risk of sexually transmitted HIV.~   "
189490|NCT01084226|"~     The purpose of this study is to investigate the antioxidative effects of alkylresorcinols~     (AR), originating from the rye fiber, on serum LDL particles and the use of AR or it's~     metabolites as biomarkers for rye fiber intake and the effect of additional plants sterols,~     incorporated in the rye bread, on serum total and LDL cholesterol concentration.~   "
189479|NCT01084369|"~     Diabetes mellitus is associated with long-term complications affecting mainly the eyes,~     nerves and kidneys. One of the main underlying causes for this is damage to the lining of the~     small blood vessels supplying these organs with dysfunction of the endothelium (lining of the~     small blood vessels). Testosterone has been shown to have an effect macro (large) blood~     vessels with limited data available on the micro (small) blood vessels. Testosterone is~     recognised to have important effects on metabolism and vascular behaviour beyond the accepted~     effects on secondary sexual characteristics. Physiological testosterone therapy is associated~     with some beneficial effects on the cardiovascular system and has been used with some success~     to treat patients with stable angina and chronic heart failure. The investigators therefore~     propose to study the effects of testosterone replacement therapy in patients with~     hypogonadism (low testosterone levels) on the endothelium in males with type 2 diabetes. 40~     diabetic patients with type 2 diabetes and low testosterone levels and erectile dysfunction~     (impotence) will be recruited into the study. All patients will receive testosterone~     replacement therapy and 10 patients will also receive Vardenafil (a drug used to treat~     impotence). The investigators hope to demonstrate an improvement in endothelial dysfunction~     by assessing biochemical markers such as nitric oxide (a chemical that causes relaxation for~     the blood vessels) and C-reactive protein (a chemical that can increase in patients with~     diabetes) as well as the effect on weight, blood pressure, diabetes control and cholesterol.~   "
189480|NCT01084356|"~     The purpose of the study is to check if the new CZT system has an advantage in detection of~     small osseous processes, thyroid adenomas, parathyroid adenomas and detection of sentinel~     node, in comparison with the techniques in use.~      Participants: 100 subjects male and female that come to the institute of nuclear medicine for~     routine screening examinations.~      The CZT screening takes 10 minutes and does not require any extra intervention to the routine~     screening.~   "
189481|NCT01084343|"~     This study is designed to investigate the safety and efficacy of a newly developed vaccine~     against HIV-1 in female healthy subjects. Safety will be assessed by local and systemic~     adverse reactions, investigations of blood and urine, and physical exam including vital sign~     measurements. Efficacy will be assessed in blood, and in vaginal and rectal mucosal samples.~   "
189482|NCT01084330|"~     A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs~     known to be effective against gastric cancer in second line therapy for patients who have~     failed one line of chemotherapy.~   "
189483|NCT01084317|"~     The aim of the research is to assess the duration of a delay in asthma diagnosis in children~     after the Program for Prevention of Allergic Diseases. Risk factors for delayed diagnosis of~     asthma in children will also be assessed. This study will answer the question of whether this~     ratio depends on the time, which indirectly proves that it can be changed by local~     intervention programs. Prove lasting effects of the Program may contribute to planning~     further local interventions focused on improving medical care for patients with bronchial~     asthma in the Lodz region, and reduce social costs associated with this disease.~   "
189484|NCT01084304|"~     Approximately 150 female volunteers wishing to become pregnant will be recruited via web~     recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation~     tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All~     volunteers will complete study questionnaires and provide a urine sample at designated time~     points though out the menstrual cycle.~      A sub-arm to this study, applied the same protocol to women in an infertility treatment~     setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to~     this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a~     diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe~     male-factor infertility (with <5 million motile sperm per ejaculate). For this arm, the~     protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.~   "
189485|NCT01084291|"~     Dengue viruses can cause dengue fever and other serious health conditions, primarily~     affecting people living in tropical regions of the world. There are four types of dengue~     virus, and infection with one does not offer protection against the others. This study will~     test whether a vaccine developed to prevent infection with dengue virus type 1 (DEN1) causes~     a response in people's immune system and is safe.~   "
189486|NCT01084278|"~     The primary objective of this study is to compare the pharmacokinetic profiles of colchicine~     and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of~     colchicine in healthy adults with normal renal function, in patients with mild, moderate or~     severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An~     additional objective of this study is to study the clearance of colchicine and its~     metabolites by hemodialysis. Secondary objectives include evaluation of the safety and~     tolerability of colchicine in the study population.~   "
189487|NCT01084265|"~     This was a prospective, open, non-comparative study to evaluate the safety and efficacy of~     recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in~     follicular development during ovulation induction in 31 Chinese female subjects with~     hypogonadotropic hypogonadism.~   "
189488|NCT01084252|"~     Primary Objective:~      Phase 1:~      To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984~     (Isatuximab).~      Phase 2 (stage 1):~      To evaluate the activity of single-agent Isatuximab at different doses/schedules and to~     select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as~     single agent or in combination with dexamethasone.~      Phase 2 (stage 2):~      To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the~     selected dose/schedule from stage1, as single agent (ISA arm) and in combination with~     dexamethasone (ISAdex arm).~      Secondary Objectives:~      Phase 1:~        -  To characterize the global safety profile including cumulative toxicities.~        -  To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing~          schedule(s).~        -  To assess the pharmacodynamics (PD), immune response, and preliminary disease response.~      Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent:~        -  Safety~        -  Efficacy as measured by duration of response, clinical benefit rate, progression free~          survival, overall survival.~      Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex):~        -  Safety~        -  Efficacy as measured by duration of response, clinical benefit rate, progression free~          survival, overall survival.~   "
189491|NCT01084213|"~     The incidence of malaria, including the incidence in pregnant women, is declining in many~     African countries. Thus, there is a need to re-examine the efficacy and cost effectiveness of~     giving intermittent preventive treatment with sulphadoxine-pyrimethamine in pregnancy~     (SP-IPTp) on several occasions during pregnancy, an intervention that is threatened by~     increasing resistance to SP. Possible alternatives to SP-IPTp need to be explored. This~     applies especially to areas with highly seasonal malaria transmission where women are at risk~     for only a short period of the year.~      The goal of this project is to determine whether in pregnant women who sleep under a long~     lasting insecticide treated bed net, screening and treatment at each scheduled antenatal~     clinic visit is as effective in protecting them from anaemia, low birth weight and placental~     infection as SP-IPTp.~      Primigravidae and secundigravidae who present at antenatal clinics in study sites in four~     West African countries (Burkina Faso, Ghana, Mali and The Gambia) will be randomised to one~     of two groups. All women will be given a long lasting insecticide treated bed net on first~     presentation at the antenatal clinic. Women in group 1 (reference group) will receive SP-IPTp~     according to the current WHO guidelines. Those in group 2 will be screened with a rapid~     diagnostic test at each scheduled antenatal clinic visit and treated if parasitaemic.~     Approximately 5000 women will be recruited, 2500 in each group. Women will be encouraged to~     deliver in hospital where maternal haemoglobin and birth weight will be recorded and a~     placental sample obtained. Those who deliver at home will be visited within a week of~     delivery and maternal haemoglobin and infant weight recorded. Mothers and infants will be~     seen again six weeks after delivery. Also at delivery peripheral maternal blood sample will~     be obtained for the diagnosis of malaria using RDT, microscopy and PCR. The primary end~     points of the trial will be birth weight and anaemia at 38 weeks (+/-2 weeks) of gestation.~     The study is powered to show non-inferiority of group 2 compared to group 1. The costs and~     cost effectiveness of each intervention will be evaluated.~      In the light of recent evidence suggesting that malaria infection during pregnancy,~     particularly in the last trimester may influence an infant's risk of malaria, we proposed to~     follow infants born to mothers recruited in the Navrongo site in Ghana who have received~     either IST or IPTp in pregnancy throughout the whole of their first year of life beyond the~     six weeks originally proposed. We have received approval for this from the ethic committees~     at Kwame Nkrumah University of Science and Technology, Ghana Health Service and Navrongo~     Health Research Centre. The aim is to obtain information on the incidence of both symptomatic~     and asymptomatic malaria infections in these infants during follow up of the infants.~      The study will provide information to national malaria control programmes on whether there~     are alternative, safe and effective methods to the SP IPTp regimen for reducing the burden of~     malaria in pregnancy.~   "
189496|NCT01084148|"~     Primary objective:~      To demonstrate the long-term efficacy (response to treatment during initial therapy, time to~     relapse without treatment, durability and lesional recurrence during maintenance therapy) of~     V0034 CR 01B cream on uraemic xerosis in the real-life setting.~      Secondary objectives:~        1. To assess the local tolerance of V0034 CR 01B after long-term use~        2. To assess the patient benefit and acceptability of V0034 CR 01B~   "
189497|NCT01084135|"~     The purpose of this study is to determine if short term use of rivastigmine can improve~     functional abilities (for example, language, memory, and executive function) in adolescents~     with Down syndrome.~   "
189498|NCT01084122|"~     The purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose~     in patients with hip fracture and surgical intervention to prevent perioperative anemia.~   "
189499|NCT01084109|"~     The specific aims of this project is to determine the impact of a daily intake of one half~     ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18~     mo) on linear growth velocity, zinc and iron intakes and status, brain growth and~     neurocognitive development, and infectious disease morbidity in populations traditionally~     dependent on non-micronutrient fortified plant foods for complementary feeding.~   "
189500|NCT01084096|"~     Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal~     mortality through increasing the rate of antenatal corticosteroid administration to eligible~     women.~   "
189501|NCT01084083|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Radiation therapy uses high energy~     x-rays to kill tumor cells. Giving paclitaxel, cisplatin, and cetuximab together with~     radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying paclitaxel, cisplatin, and cetuximab to see how well~     they work when followed by cetuximab and two different doses of intensity-modulated radiation~     therapy in treating patients with HPV-associated stage III or stage IV cancer of the~     oropharynx that can be removed by surgery.~   "
189502|NCT01084070|"~     The traditional postoperative care after abdominal surgery included the need of nasogastric~     tube, fasting until resumed bowel function and progressive reinstitution of oral intake from~     liquid to solid diet. Recent studies have shown no benefits of this traditional management~     over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.~   "
189503|NCT01084057|"~     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing or~     by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving ixabepilone together with vorinostat may~     kill more tumor cells.~      PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and~     best dose of vorinostat when given together with ixabepilone in treating patients with breast~     cancer that has spread to another place in the body.~   "
189504|NCT01084044|"~     Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing~     off-pump coronary bypass surgery (OPCAB).~   "
189505|NCT01084031|"~     Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation~     induction.~   "
189506|NCT01084018|"~     The purpose of this project is to develop and evaluate the effects of a computer-tailored~     intervention targeting pain barriers and catastrophizing in adults having cardiac surgery.~      The hypotheses are that in the experimental group, in comparison to the control group,~     participants will show lower levels of pain, less pain interference in their activities, less~     attitudinal barriers, and less pain catastrophizing.~      A pilot-RCT is privileged to assess the preliminary effects of the intervention on the~     following outcomes: pain intensity, analgesic consumption, pain interference, barriers and~     pain catastrophizing.~   "
189507|NCT01084005|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to~     stable treatment in elderly patients with T2DM with insufficient glycaemic control~   "
189508|NCT01083992|"~     Sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and~     increasing the risk for developing nonalcoholic fatty liver disease (NAFLD). The strong~     relationship between insulin resistance and NAFLD suggests that adding Vitamin D TO insulin~     sensitizing therapies such as Galvus (vitagliptin) might be beneficial in the prevention or~     improvement in NAFLD. Considering the close relationship between NAFLD and T2DM and lipid~     metabolism, we assume that adding vitamin D to Galvus, may be effective for NAFLD by~     improving lipid metabolism and by improving type 2 diabetes mellitus (T2DM).~   "
189509|NCT01083979|"~     The objective is to instill liposomes reconstituted with sterile water into the bladder as a~     compassionate use treatment in one patient with ulcerative interstitial cystitis (IC).~   "
189510|NCT01083966|"~     A recent study by Plotkin et al. showed that bevacizumab (Avastin) treatment was followed by~     clinically meaningful hearing improvement, tumor-volume reduction, or both in some, but not~     all, patients with Vestibular Schwannoma (VS) who were at risk for complete hearing loss or~     brain-stem compression from growing VS. Because of the promising results in preliminary~     studies of Bevacizumab and because of significant experience with the safety of the dosages~     proposed in this study, this study will offer a safe treatment for patients with VS.~     Therefore, this phase I clinical research trial will test the hypothesis that Bevacizumab can~     be safely used by direct intracranial superselective intraarterial infusion up to a dose of~     10mg/kg to ultimately enhance survival and hearing function of patients with VS.~   "
189511|NCT01083953|"~     The purpose of this study is to determine the optimal volatile anaesthetic (sevoflurane and~     desflurane) to remove a Supreme LMA in adults in which there is minimal airway response.~      Null hypothesis: there is no significant difference between the optimal end tidal~     concentration of sevoflurane and desflurane for Supreme LMA removal.~   "
189527|NCT01083732|"~     To investigate the safety and tolerability of dabigatran etexilate solution in children and~     to obtain preliminary pharmacokinetic/pharmacodynamic data~   "
189512|NCT01083940|"~     In response to the Finding Answers: Disparities Research for Change call for proposals by the~     Robert Wood Johnson Foundation, we were funded to evaluate the effectiveness of a planned~     computerized decision support (CDS) intervention aimed at medical providers to overcome~     clinical inertia when treating blood pressure for hypertensive patients. Based on prior~     evaluation of the Brigham and Women's Hospital (BWH) adult primary care clinics, we~     hypothesize that racial and ethnic differences in blood pressure outcomes are largely~     attributable in differences in providers' aggressiveness in managing patients with~     hypertension based on patients' race and ethnicity. Within our network of 14 hospital and~     community-based Brigham and Women's Hospital adult primary care clinics, we aim to determine~     if the use of CDS to remind to medical providers of poorly controlled hypertensive patients~     to intensify their hypertension therapy will improve overall rates of blood pressure control~     and reduce the previously documented racial and ethnic disparities in blood pressure outcomes~     among our hypertensive patient population. Clinics will first be stratified by location~     (hospital-based versus community-based) and within each strata will be randomized to either~     have their providers receive CDS for hypertensive patients whose most recent blood pressure~     was uncontrolled or to usual care for hypertensive patients. More specifically, we will~     evaluate our planned intervention by utilizing an 18 month cluster-randomized controlled~     trial to examine the effectiveness the CDS for intensification of hypertension therapy in:~     improving levels of blood pressure control, improving provider adherence with recommended~     changes in drug therapy, and reducing racial/ethnic disparities in the processes of~     hypertension care and outcomes among our patients receiving primary care for a diagnosis of~     hypertension.~   "
189513|NCT01083927|"~     To compare the efficacy of rotational narrow strip conjunctival graft to full conjunctival~     graft in primary pterygium excision. Risk analysis of factors that may affects the recurrence~     rate.~   "
189514|NCT01083914|"~     The purpose of this study is to compare blood loss and the number of transfusions received by~     each patient having coronary bypass surgery. The second purpose is to determine how the level~     inflammation in patients during and after surgery may affect a patient's response to surgery~     and the recovery process.~   "
189515|NCT01083901|"~     The purpose of this study is to determine if taking the pain reliever acetaminophen (ACET)~     interferes with some of the benefits of weight lifting on muscles and bone density in older~     men.~   "
189516|NCT01083888|"~     To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal~     anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these~     patients.~   "
189517|NCT01083875|"~     The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared~     to a vehicle control on mucositis-related ulceration and erythema (objective score)and on~     mucositis-related oral pain (subjective score).~      A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining~     the frequency of treatment-emergent drug-related adverse events or clinical laboratory~     abnormalities.~   "
189518|NCT01083862|"~     Study objective was to explore the impact of health literacy on effectiveness of an~     educational intervention describing life-style and behavior modification for patients Living~     with Coronary Artery Disease. Our hypothesis was that a VHS/DVD version of this educational~     program would be superior to printed material alone in its impact on patients' knowledge~     about coronary artery disease and important life-style changes. Furthermore, we believed this~     effect would be most notable among patients with low health literacy. We also were interested~     in the impact of the interventions on secondary outcomes including - health behaviors, health~     outcomes and patients' subjective experiences.~   "
189519|NCT01083849|"~     The purpose of this study is to obtain data on the safety and effectiveness of Zemplar®~     (paricalcitol) injection and paricalcitol capsules in real-life clinical practice.~     Participants, who have been treated with paricalcitol in-label in an everyday setting, have~     been included into this study. A period of 12 months has been chosen in order to also obtain~     experience on the maintenance dose and treatment optimization with paricalcitol injection and~     paricalcitol capsules in long-term use.~   "
189520|NCT01083823|"~     We will modify our existing VMQ/VADIS mood telemetry software to run on a Motorola platform,~     and enhance it to collect information on both mood symptoms (currently covered by the~     VMQ/VADIS) as well as daily life stressors (currently outside the VMQ/VADIS' scope). By doing~     so, we will be able us to examine the role of daily stressors in the lives of teens with and~     without mood swings, to identify how changes in mood triggered by stressful events are~     similar to or different from mood changes linked to the bipolar disorder, borderline~     personality disorder, or other forms of affective instability.~   "
189521|NCT01083810|"~     Long term observation of patients under lopinavir/ritonavir containing therapy~   "
189522|NCT01083797|"~     This study evaluates the use of dexmedetomidine or chloral hydrate for sedation during~     electroencephalography in patients with neurological disorders. The hypothesis is that this~     drugs provides similar changes in EEG pattern.~   "
189523|NCT01083784|"~     Cardiac arrest is a leading cause of sudden death, but the survival rate of cardiac arrest is~     only 5-35%.~      Although, the first resuscitation of cardiac arrest patient would be success, the hypoxic~     brain injury after cardiac arrest is an important cause of the mortality and the morbidity.~      For the management of the hypoxic brain injury after cardiac arrest, American Heart~     Association and European Resuscitation Council recommend induced mild hypothermia therapy.~     And, ILCOR(International Liaison Committee on Resuscitation) announced the standard treatment~     of post cardiac arrest syndrome(the success state of first resuscitation of the cardiac~     arrest patient) included the induced mild hypothermia therapy at September, 2008.~      The generalized seizure and myoclonus arise in over 60% of post cardiac arrest syndrome~     patients and they are very difficult to control. Also, the occurrence of them implies poor~     prognosis of the patient.~      Although, mild hypothermia therapy could be decrease the development and propagation of~     generalized seizure and myoclonus theologically, the therapy could not prevent the~     development and propagation of them entirely. Therefore, the use of prophylactic~     anticonvulsant should be needed. But, there is not randomized control study about the use of~     prophylactic anticonvulsant.~      We hypothesized that the use of prophylactic anticonvulsant to post cardiac arrest syndrome~     patients would decrease the rate of occurrence of generalized seizure and myoclonus and would~     improve the neurologic outcome.~      We planed that we used two anti-epileptic drugs - valproate, clonazepam - for the~     prophylactic anticonvulsant. The valproate and clonazepam are in general use for prevention~     and treatment of generalized seizure and myoclonus and are recommended to treat of~     generalized seizure and myoclonus to post cardiac arrest syndrome patients by 2008 guideline~     of ILCOR.~   "
189524|NCT01083771|"~     The purpose of this study is to assess for changes in a patient's overall energy level and~     well-being (quality of life) after 8 weeks of dietary intervention.~   "
189525|NCT01083758|"~     The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO~     80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis.~     LEO 80185 topical suspension has marketing approval in many countries under the brand names~     Taclonex Scalp® Topical Suspension and Xamiol® gel for the treatment of scalp psoriasis in~     adults. No studies have been performed in subjects younger than 18 years.~   "
189526|NCT01083745|"~     The etiology of infertility in the majority of patients with poor response to ovarian~     stimulation remains unknown. This study will investigate the role of immune cells (T cells, B~     cells, dendritic cells and NK cells), that constitute the immune system which normally fights~     infection and cancer. We, the investigators, have found that specialized NK cells that help~     with new blood vessel formation, are found in the fluid surrounding the egg during IVF, only~     in patients with good response to ovarian stimulation. We now wish to expand our studies and~     correlate our findings to ovarian blood flow , as measured by 3D ultrasound and to the~     presence of other cells in the immune system.~   "
189528|NCT01083719|"~     HYPOTHESIS AND SAMPLE SIZE The tumor delineated by FDG-PET is significantly different from~     the delineation achieved by MR T1 contrast weighted images in glioblastoma; expecting a~     standard error of 12.5 % (a confidence interval of 25%), with a confidence level set at 95%,~     a sample size of 15 patients would be accrued in the study.~   "
189529|NCT01083706|"~     This phase II trial studies how well azacitidine works in treating patients with relapsed~     myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid~     leukemia (AML) who have undergone stem cell transplant. Drugs used in chemotherapy, such as~     azacitidine, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing.~   "
189530|NCT01083693|"~     The aim of this post-marketing observational study is to obtain further data on the~     evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with~     Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after~     unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or~     biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate~     to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing~     spondylitis commonly consist of introducing biologics after conventional disease modifying~     antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease~     modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or~     efficacy may diminish, at which time another biologic disease modifying antirheumatic drug~     might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given~     after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug~     failures and or after biological disease modifying antirheumatic drug failures . Failure in~     this context means primary or secondary loss of efficacy or intolerance to the initial agent.~   "
189531|NCT01083680|"~     The purpose of this study was intended to evaluate the long-term safety and effectiveness of~     adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the~     product label.~   "
189532|NCT01083667|"~     The objective of this study will be to evaluate the safety, tolerability and effect on SOD1~     levels by pyrimethamine in patients with familial amyotrophic lateral sclerosis.~   "
189533|NCT01083654|"~     The purpose of this community-based study is to evaluate the effectiveness of a~     culturally-tailored smoking cessation treatment for American Indian (AI) smokers as compared~     to standard evidence-based cessation treatment (not culturally-tailored).~   "
189534|NCT01083641|"~     The purpose of this study is to determine the effectiveness of Estradiol treatment for~     advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study~     will also use tumor tissue from your original diagnosis or from a biopsy you may have had for~     your cancer to look at hormone receptors in the lab. The tissue left over from your previous~     surgery or a previous biopsy will be used for research tests to check whether a different~     estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen~     work better.~   "
189535|NCT01083628|"~     This study will assess the feasibility and acceptability of using mobile phone text messages~     (SMS) as adjuncts to existing group cognitive-behavioral treatment (CBT) for depression at~     San Francisco General Hospital. Patients in current groups will be given the option to~     participate in a text-messaging adjunct in lieu of the usual paper and pencil homework that~     is typically assigned during group sessions. They will also be provided with CBT relevant~     tips and skills to employ during particularly stressful times. Participants will receive~     daily text messages asking them what their mood is, this will help them become aware of their~     mood state and provide feedback to the group leaders as to the progress of the patient.~     Patients will also receive 1-2 additional messages a day depending on the module of focus for~     that month (i.e. thoughts, activities, people, and health). These additional messages include~     1) thought tracking (both positive and negative), 2) tracking of pleasant activities, 3)~     tracking of positive and negative contacts, 4) tracking of physical wellbeing. Additionally,~     participants will receive reminders of weekly group meetings in an attempt to improve~     adherence. Patients that are taking medication will be offered to receive reminders to take~     medication according to their prescribed regimen. Another component of the SMS messages will~     allow patients to text the keyword STRESSED and receive a randomly generated message that~     will suggest cognitive and behavioral tips to counteract the stress or sad mood. They will~     also be able to text the word HELP and receive the number for a suicide hotline or be~     prompted to contact 911 for an emergency. Lastly, participants will be given feedback on~     their mood, behaviors and cognitions through visual graphs that display their status over~     time. This will allow patients to see the connection between mood behavior and cognition.~     This study is not intended to test hypotheses.~   "
189536|NCT01083615|"~     The purpose of this study is to determine if the addition of study drug (custirsen) can~     provide durable pain palliation for castrate resistant prostate cancer patients receiving~     docetaxel retreatment or cabazitaxel as a second line therapy.~   "
189537|NCT01083602|"~     This study is designed to assess the effectiveness of the combination of Panobinostat plus~     Bortezomib and Dexamethasone in patients with relapsed and bortezomib refractory Multiple~     Myeloma.~   "
189538|NCT01083589|"~     The goal of this clinical research study is to learn how effective the combination of the~     drugs imatinib mesylate (Gleevec®) and docetaxel (Taxotere®) is in treating non-small cell~     lung cancer (NSCLC). The safety and tolerability of this drug combination will also be~     studied.~   "
189539|NCT01083576|"~     The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy~     of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in~     subjects with cutaneous leishmaniasis (CL).~   "
189540|NCT01083563|"~     The purpose of this study is to examine the effect of anti-TNF therapy on rheumatoid~     arthritis using magnetic resonance imaging (MRI) and ultrasound imaging.~      Anti-TNF therapies include a group of medications such as Enbrel, Remicade and Humira that~     affect your body's inflammatory response. These medications are routinely prescribed for the~     treatment of rheumatoid arthritis.~   "
189541|NCT01083550|"~     In this study, we will test, using a randomized controlled trial design, whether the use of a~     computer-based decision aid (DA) may improve general knowledge and reduce personal decisional~     conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual~     care. Patients with early stage PTC will be required to have surgical pathologic criteria for~     which adjuvant RAI treatment may be considered optional.~   "
189553|NCT01083394|"~     The aim of this study is to perform a randomized, controlled trial to compare percutaneous~     transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional~     balloon for treatment of superficial femoral artery in-stent restenosis.~   "
189554|NCT01083381|"~     In this study we want to find out whether MS14 - a herbal drug- can help Schizophrenia~     patients or not.~   "
189542|NCT01083537|"~     The best way to treat MBO in patients with ovarian cancer has not been studied enough by~     trials that assess how more than one treatment arm (surgical, chemotherapeutic, supportive~     care approaches) affects clinical outcomes like resolution of bowel obstruction, survival,~     and quality of life. To improve patient outcomes, we must assess which patients will do~     better with palliative surgery, chemotherapy, or best supportive care. This study will gather~     safety information, and how reasonable it is to give chemotherapy and BSC to patients with~     advanced ovarian cancer and MBO who are non-surgical candidates. This study will also look~     into the effects of chemotherapy and BSC on the quality of life and resolution of bowel~     obstruction, in hopes to perform future studies that lead to the best management of MBO.~   "
189543|NCT01083524|"~     Hypothesis: The small molecule and metabolic modulator Dichloroacetate (DCA) is safe,~     tolerated as a potential therapy in patients with moderate or severe Pulmonary Arterial~     Hypertension (PAH).~      This is a Phase I, two centre study in subjects with PAH WHO functional class III-IV whose~     symptoms have been clinically stable on their prescribed medical treatment (which includes~     endothelin and/or phosphodiesterase type 5 inhibitors) for 8 weeks prior to enrollment. Such~     patients will be given either DCA 3.0 mg/kg BID (group I), 6.25 mg/kg BID (group II) or 12.5~     mg/kg BID (group III) as an additional treatment for 16 weeks. The design is open-label with~     the subjects acting as their own controls.~      Primary endpoint is the safety and tolerability of DCA. Secondary end points include: a)~     functional capacity including a change in the 6 minute walk form baseline, b) change in~     pulmonary vascular resistance (measured by right heart catheterization), c) right ventricular~     volumes and mass (measured by MRI), d) NT-proBNP levels changed from baseline, e) change in~     FDG-glucose uptake in the lung and right ventricle (measured by PET) and f) change in quality~     of life indices.~      15 evaluable patients in each site are expected to be included.~   "
189544|NCT01083511|"~     The study will be conducted with nasopharyngeal swab specimens collected prospectively from~     individuals suspected of having an acute respiratory tract infection caused by an Influenza~     virus. A series of standard viral culture tests validated for routine use in the clinical~     laboratory, as well as the CDC swine H1N1 test will be used to establish a collection of well~     characterized specimens. For each specimen four (4) aliquots will be prepared. One aliquot~     will be tested in real-time using the requisite viral culture reference methods, one aliquot~     will be used for H1N1 reference testing, one aliquot will be used to extract nucleic acid in~     real-time, and one aliquot of the UTM will be archived for the purpose of sequencing to~     confirm Influenza-positive specimens. The extracted nucleic acid and any remaining specimen~     will be stored at -70°C for later testing by the artus Influenza RG PCR test, or other~     investigational method(s).~   "
189545|NCT01083498|"~     The purpose of this study is to determine whether the use of ablative fractional laser is~     effective in the treatment of Becker's nevus.~   "
189546|NCT01083485|"~     The purpose of this study is to demonstrate that treatment with OXN PR tablets is non~     inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with~     postoperative pain after knee arthroplasty based on average pain intensity scores.~   "
189547|NCT01083472|"~     The objective of this study is to compare the incidence of post-repair wound related~     complications, including hernia occurrence/recurrence, between challenging abdominal wall~     defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by~     standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair~     will reduce the incidence of these post-repair complications.~   "
189548|NCT01083459|"~     The purpose of this study is to determine the impact of pneumococcal conjugate vaccine on~     carriage of pneumococcus in the nasopharynx and on the incidence of invasive pneumococcal~     disease in the community.~   "
189549|NCT01083446|"~     This trial will study a possible effect of standard Israeli breakfast (30% of caloric value~     and 21 gram protein) on cognitive and executive functions (working memory, visual memory,~     concentration and coordination), on patients with mild-moderate liver cirrhosis.~   "
189550|NCT01083433|"~     The purpose of this research study is to find out ways to help pre-teens and teens and their~     families to improve diabetes control and to help with the burden of diabetes management.~     Specifically, the study aims to find out if coming to diabetes clinic more frequently and for~     a longer period of time helps adolescents with diabetes, and if adolescents who wear a~     continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.~   "
189551|NCT01083420|"~     The aim of the present study is to assess the clinical efficacy of topical minocyclin in~     managing of symptoms associated with oral lichen planus (OLP). The rationale of the study is~     based on our previous studies demonstrating the beneficial effect of minocyclin mouthwash on~     recurrent aphthous stomatitis. The planned study will be a randomized controlled, cross-over~     trail. Patients with symptomatic OLP will randomly receive minocycline or dexamethasone~     rinses.~      The patients will rinse and expectorate 5 ml of the 1st mouthwash 4 times daily for 14 days.~     Subjects will complete a daily follow-up form that includes data regarding the daily~     intensity of pain (using VAS) caused by OLP and regarding possible side effects. After a~     washout period (at least 14 days) the patients will repeat the protocol with the second~     mouthwash.~   "
189552|NCT01083407|"~     This experimental study aims to verify the influence of the oral hygiene performance with~     chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection~     begun in April, 2005 during the performance of the masters degree course dissertation~     entitled Clinical study about the effect of the oral hygiene with chlorhexidine digluconate~     0.12% in the oropharynx colonization of children in intensive care, being performed in a~     PICU of nine beds in a university hospital in the city of São Paulo, after approval of the~     Research Ethics Committee of the institution. The study is composed by three types of~     variables: Independent variable, dependent variables, and complementary variables. The~     categorical variables will be analyzed in accordance with the Person's Chi-Square test of or~     Fisher's exact test. The numerics will be submitted to the analysis of variance ANOVA or~     Kruskall Wallis. For variables with heterogeneous distribution between the groups, the~     multivariate analysis will be applied to the evaluation of the influence in the determination~     of the development risk of the dependent variable. The rejection level will be fixed in 0.05~     of the nullity hypothesis.~   "
196065|NCT00997009|"~     This study aims to assess the activity of a combination of cetuximab (weekly) with~     carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of~     event-free survival (EFS).~   "
189555|NCT01083368|"~     RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Giving temsirolimus together~     with bevacizumab may be a better way to block tumor growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus~     when given together with bevacizumab and to see how well it works in treating patients with~     hormone-resistant metastatic prostate cancer that did not respond to chemotherapy.~   "
189556|NCT01083355|"~     Healthy biological systems are characterized by a normal range of variability in organ~     function. For example, many studies of heart rate clearly document that loss of the normal~     level of intrinsic, beat-to-beat variability in heart rate is associated with poor prognosis~     and early death.~      Unlike the heart, little is known about patterns of respiratory variability in illness. What~     is known is that, like the heart, healthy subjects have a specific range of variability in~     breath- to-breath depth and timing. Additionally, in animal models, ventilator strategies~     that re-introduce normal variability to the breathing pattern significantly reduce~     ventilator-associated lung injury.~      Critically ill patients requiring mechanical ventilation offer an opportunity to observe and~     analyze respiratory patterns in a completely non-invasive manner. Current mechanical~     ventilators produce real-time output of respiratory tracings that can analyzed for~     variability.~      The investigators propose to non-invasively record these tracings from patients ventilated in~     the intensive care units for mathematical variability analysis. The purpose of these pilot~     analyses are to: (1) demonstrate the range of respiratory variability present in the~     mechanically ve ventilated critically ill and (2) demonstrate the ventilator modality that~     delivers or permits the closest approximation to previously described beneficial or normal~     levels of variability. Future studies will use this pilot data in order to determine if the~     observed patterns of respiratory variability in mechanically ventilated critically ill~     subjects have prognostic or therapeutic implications.~   "
189557|NCT01083342|"~     The purpose of this study is to evaluate the complete response (CR) rate after HD-MTX~     induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based~     combination consolidation chemotherapy~   "
189558|NCT01083329|"~     Our working hypothesis postulates that lipolysis is a determinant of inflammation in adipose~     tissue (AT). Inhibition of lipolysis, e.g. using the oldest normolipidemic drug, nicotinic~     acid, has proved valuable to combat the metabolic syndrome. Our proposal will determine~     whether part of the beneficial effects of this antilipolytic compound is due to a diminution~     of AT inflammation.~      To this aim, the effect of nicotinic acid or placebo will be studied in male obese subjects~     with or without a training program which goal is to enhance lipolysis.~   "
189559|NCT01083316|"~     The drugs dexamethasone and bortezomib are both FDA-approved for the treatment of multiple~     myeloma, a disease very similar to amyloidosis. However, they are currently investigational~     for the treatment of amyloidosis.~      We want to find out if the addition of dexamethasone and bortezomib to standard high dose~     chemotherapy and stem cell transplant can help improve response.~      Standard treatment includes four steps: 1) Stem Cell Mobilization (standard) 2) Stem Cell~     Collection (standard) 3) Conditioning Regimen (Melphalan chemotherapy). The conditioning~     regimen helps to kill the abnormal cells in the body and makes room in the bone marrow for~     new blood stem cells to grow. 4) Stem Cell Infusion~      Participants in this study will have an additional treatment step called induction therapy,~     designed as the first step towards reducing the number of abnormal cells in the body. Two~     cycles of the investigational drugs bortezomib and dexamethasone will be given during~     induction therapy. In addition, bortezomib will given as part of the conditioning regimen, in~     addition to the standard melphalan chemotherapy.~   "
189560|NCT01083303|"~     Background: The weight at which infants are weaned from incubators varies among neonatal~     units.~      Objective: To determine the effect on weight gain, temperature stability and resting energy~     expenditure (REE) of weaning infants at body weight of 1500 g versus 1600 g.~      Design/Methods: infants will be randomized to incubator weaning at the weight of 1500 g or~     1600 g. Preterm infants 1500 g birth weight, fully enterally fed, and without supplemental~     oxygen, at the postnatal age of 2 weeks will be included. Infants will be weaned to a warming~     bassinet (Babytherm 8000, Dräger) set to keep a mattress temperature of 37°C while decreasing~     it gradually to room temperature. Failure to wean is defined as core body temperature of <~     36.1°C. Data collection included skin and rectal temperature obtained before weaning, and at~     1/2, 1, 2, 6, 24, and 48 hours after weaning, weekly weight gain (g/kg/d). REE (kcal/kg/24h)~     will be measured by indirect calorimetry (Deltatrac II, Finland) before and 24 hours after~     weaning.~   "
189561|NCT01083290|"~     Objective is to investigate pharmacokinetics and to estimate the level of dose linearity of~     spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone from~     Spironolactone 25 mg, 50 mg and 100 mg Tablets~   "
189562|NCT01083277|"~     Acute respiratory failure requiring support with mechanical ventilation occurs with an~     incidence of 77-100 per 100,000 person-years and accounts for half of all patients admitted~     to the intensive care unit. Major causes of acute respiratory failure include pneumonia,~     asthma, emphysema, and acute lung injury. These causes of acute respiratory failure may~     result in partial lung collapse (atelectasis), and airway narrowing (bronchoconstriction)that~     result in decreased oxygen levels requiring support with the ventilator. The prolonged~     inactivity in the supine position associated with mechanical ventilation can further result~     in atelectasis requiring increased oxygen supplementation through the ventilator.~      The current standard of care in acute respiratory failure is a strategy of mechanical~     ventilation using a single lung volume delivered repeatedly. However, the current standard~     mechanical ventilation strategy is not consistent with the variability in respiration of~     healthy humans and has been shown to contribute to increased lung injury in some studies. The~     mortality associated with acute respiratory failure is high, 30-40%. Thus, improvements in~     mechanical ventilation strategies that improve oxygen levels and potentially decrease further~     lung injury delivered by the ventilator are warranted.~      Recent studies by BU Professor Bela Suki and others in humans and animals with acute lung~     injury, bronchoconstriction, and atelectasis have shown that varying the lung volumes~     delivered by a ventilator significantly decreases biomarkers of lung injury, improves lung~     mechanics, and increases oxygenation when compared to identical mean volumes of conventional,~     monotonous low lung volume ventilation.~      Therefore, we propose a first-in-human, Phase I study to evaluate the safety of this novel~     mode of ventilation, Variable Ventilation, during acute respiratory failure~   "
189563|NCT01083264|"~     Influence of different application sites on the blood levels after administration of a~     fertility control patch~   "
189744|NCT01080885|"~     The goals of this study are to evaluate the feasibility, acceptability, and potential~     efficacy of an innovative obesity prevention intervention integrating pediatrician counseling~     and a home-based program to prevent unhealthy weight gain among 2-4 year old children at risk~     for obesity.~   "
189564|NCT01083251|"~     Abstract~      Telbivudine is a potent inhibitor of HBV but, due to a low genetic barrier to resistance, a~     high incidence of resistance has been observed in patients with high baseline levels of~     replication and in those with detectable HBV DNA after 24 weeks of therapy (A1). Telbivudine~     might be used in patients with good predictors of response (HBV DNA <2 X 106 IU/ ml, i.e.~     approximately 107 copies/ ml, or 6.3 log 10 IU/ ml at baseline) with verification of HBV DNA~     suppression below detection in real time PCR assay at 24 weeks.(EASL Guidelines for HBV 2009)~     The therapy of Pegylated-interferon-alpha-2a is considered as the standard of care for~     patients with chronic hepatitis b viral infection. However, recent study by Buster et al~     showed that a sustained viral response (SVR less than 2000 iu.ml at 6 months after~     treatment)) is obtained in 8 % of patients with genotype D, 30% genotype A, and 20-25%~     genotypes B or C (47). Vitamin D is a potent immune-modulator; and has been shown to improve~     SVR in combination with peg interferone in patients with chronic HCV viral infection (48).~     The impact of vitamin D on virologic response rates of interferon-based treatment of CHB is~     unknown. The aim of this study therefore was to assess whether Vitamin D, added to the~     conventional peg therapy in CHB, or to nucleotide analogues could improve the treatment~     efficacy~   "
189565|NCT01083238|"~     AZD5069 is a new drug being tested for the possible treatment of people with chronic~     obstructive pulmonary disease (COPD).~      This is not the first time that AZD5069 will be administered to humans in clinical trials. We~     are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy~     males and females in fed and fasted states. We will compare the way the body handles this~     drug in the fed and fasted states, in subjects in the age group of 18 to 65 years. We will~     compare the way the body handles this drug between the age groups of 18 to 65 years and above~     65 years. We will also be studying how quickly AZD5069 is absorbed into and cleared by the~     body.~   "
189566|NCT01083225|"~     The purpose of this study is to evaluate the effect of individual user involvement in an~     outpatient mental health center. The intervention consists of patients completing a~     self-report symptom and problem questionnaire and reviewing it with a clinician.~   "
189567|NCT01083212|"~     The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics~     and Pharmacodynamics of a Single Dose of AZD1656~   "
189568|NCT01083199|"~     1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate~          sustainable vesico-urethral anastomosis during a radical prostatectomy procedure.~        2. To assess clinical outcomes of the Device in facilitating the vesico-urethral~          anastomosis following a radical prostatectomy.~   "
189569|NCT01083186|"~     The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in~     real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and~     secondary hyperparathyroidism.~   "
189570|NCT01083173|"~     This single-arm, multi-center, Post-Marketing Surveillance study of Kaletra~     (lopinavir/ritonavir) was conducted in accordance with the approved Korean product labeling~     in participants 2 years of age and older with human immunodeficiency virus type 1 (HIV-1)~     infection.~   "
189571|NCT01083160|"~     This is a prospective, single-arm, post marketing observational study in adult patients with~     active rheumatoid arthritis (RA) who are discontinuing treatment due to lack of efficacy,~     intolerance or to an incomplete response with either infliximab or etanercept.~      The aim of this post-marketing observational study is to obtain data on clinical outcomes,~     compliance and tolerability to determine the effectiveness of switching from infliximab or~     etanercept to adalimumab. In this cohort, the different treatment strategies are to be~     studied in the context of the routine clinical practice in the different participating~     places.~   "
189572|NCT01083147|"~     The purpose of this study is to evaluate the compliance of the Foresee Home device in~     intermediate AMD patients.~   "
189573|NCT01083134|"~     With the advances in multidetector computed tomography (MDCT) technology, CT angiography~     (CTA) of the coronary arteries using 64-slice or dual-source CT systems has evolved into a~     robust, alternative, noninvasive imaging technique to rule out coronary artery disease (CAD).~     Reported sensitivities and specificities of coronary CTA can compete with those of catheter~     angiography.~      Because CT is the major source of ionizing radiation in medicine, dual isotope myocardial~     perfusion scintigraphy and coronary CTA 16-, 64-slice MDCT and DSCT scanners are associated~     with the highest amount of radiation dose. Recently, a new generation of MDCT machines with~     even more detector row (320) has become clinically available. The maximum detector width of~     16 cm enables the entire heart to be examined in a single rotation and within a single~     heartbeat and is expected to substantially reduce artifacts from breathing and body motion.~     Due to high volume coverage, 320-slice CT machines are able to perform a nonspiral, ECG-gated~     examination of the heart within a single breath-hold.~      The purpose of this study was to investigate the correlation of hemodynamic status of 320~     MDCT, echocardiography, and coronary catheterization in patients who suspected coronary~     artery disease.~   "
189574|NCT01083121|"~     Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and~     observed in normal medical practice setting for not less than 3 months following first dose~     of Humira. Information on demographics, diagnosis and medical history, results of~     tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant~     medication, physician's global assessment for effectiveness, disease activity assessment for~     rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity~     assessment for Psoriasis and adverse events will be recorded on case report forms.~   "
189593|NCT01082874|"~     Major surgeries not involving the heart are common, and major heart problems during or after~     such surgeries represent a large population health problem. Few treatments to prevent heart~     problems around the time of surgery have been tested. There is encouraging data suggesting~     that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications,~     given individually for a short period before and after major surgeries may prevent major~     heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine~     can prevent heart attacks and deaths from heart problems around the time of surgery.~   "
189745|NCT01080872|"~     The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary~     flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS)~     and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.~   "
189575|NCT01083108|"~     Background:~        -  Bariatric surgery is the most effective way to achieve significant, long-term weight~          loss. It has also been shown to be an effective therapy for obese individuals with type~          2 diabetes: more than 70 percent of patients no longer need medications for diabetes~          after surgery. This resolution of diabetes is predominately caused by marked weight loss~          resulting in improved insulin sensitivity. However, the beneficial effects of bariatric~          surgery on type 2 diabetes cannot be accounted for entirely by weight loss, because many~          bariatric surgery patients have resolution of diabetes within 1 week following bariatric~          surgery, even before they lose a clinically significant amount of weight.~        -  One possible reason for the rapid resolution of diabetes after bariatric surgery .is~          that during the first week after surgery, patients can eat very little (about 300~          Calories per day). It is well known that reducing calories to this level improves~          diabetes. Another possibility is that changes in the flow of food through the intestines~          may improve diabetes. Evidence for this comes from the observation that patients after~          gastric bypass have better glucose levels than those who have gastric banding.~          Researchers are interested in determining how much of the improvement in diabetes in the~          first week after Roux-en-Y gastric bypass (RYGBP) surgery is due to restricting~          calories, and how much is due to other factors, such as bypassing the upper part of the~          small intestine.~      Objectives:~        -  To determine the change in total body insulin sensitivity after RYGBP compared to~          caloric restriction without surgery.~        -  To study possible reasons for improvements in diabetes after RYGBP.~      Eligibility:~      - Individuals 18 to 60 years of age who have a body mass index (BMI) greater than 35 and have~     type 2 diabetes.~      Design:~      - This is not a randomized study, and patients will not receive bariatric surgery as part of~     this study.~      Two groups of patients will be studied: those scheduled for RYGBP surgery and those not~     undergoing surgery.~        -  RYGBP Surgery Participants:~        -  Up to 3 weeks before surgery, participants will spend 2 nights and days at the~          Vanderbilt University Clinical Research Center or the NIH Clinical Center for testing to~          learn about how their bodies handle sugar and use energy. During the 5 days prior to~          these tests, participants will be asked to not take diabetes medications, and will check~          blood sugar at least twice a day.~        -  From 8 days before surgery, participants will begin an 800 Calorie per day liquid diet~          to prepare for surgery.~        -  After surgery and discharge, participants will be readmitted to the Clinical Research~          Center at Vanderbilt or NIH for further tests and diet monitoring. Diabetes medications~          may be adjusted or stopped altogether based on the results of the tests.~        -  Non-surgery Participants:~        -  Participants will spend 2 nights and days in the NIH Clinical Center for testing to~          learn about how their bodies handle sugar and use energy. During the 5 days prior to~          these tests, participants will be asked to not take diabetes medications, and will check~          blood sugar at least twice a day.~        -  After the tests, participants will begin an 800 Calorie per day liquid diet for 8 days.~        -  After 8 days, participants will be readmitted to the Clinical Center at NIH for 1 week~          of further tests and a 300 Calorie per day diet. Diabetes medications may be adjusted or~          stopped altogether based on the results of the tests.~   "
189576|NCT01083095|"~     A clinical trial aimed to standardize a vivax sporozoite infection model in human volunteers~     was conducted at the Malaria Vaccine and Drug Development Center (MVDC) in collaboration with~     the Immunology Institute at Valle State University and the Fundación Clínica Valle del Lili~     (FCVL) in Cali, Colombia.~      The primary objective was to determine if naïve human volunteers could be safely and~     reproducibly infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites~     in their salivary glands and a secondary objective consisted in determining the minimal~     number of infected mosquitoes required to infect all volunteers, with a reproducible~     pre-patent period.~      The trial was divided into two steps: Step A directed to obtain human blood infected with~     P.vivax parasite used to infect anopheles mosquitoes and Step B to produce P. vivax~     sporozoites in Anopheles mosquitoes to determine the dose response of naive human volunteers~     exposed to 3 +/- 1, 6 +/- 1 y 9 +/- 1 mosquitoes bites. A total of 15 samples of P. vivax~     infected donors were used to infect different batches of mosquitoes.~   "
189577|NCT01083082|"~     Objectives: To analyze the relationship of physical activity, fitness, energy intake and~     dietary pattern with the circadian pattern of blood pressure, central and peripheral blood~     pressure pulse wave velocity and biological markers of endothelial dysfunction in active and~     sedentary people without atherosclerotic disease.~   "
189578|NCT01083069|"~     Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive~     deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH)~     lowers mortality and reduces neurologic damage after cardiac arrest. The investigators~     evaluated the long term neurological outcome after mild hypothermia after restoration of~     spontaneous circulation.~   "
189579|NCT01083056|"~     This observational study investigates the effects of epimacular membrane peeling on the~     structure and function of the retina.~   "
189580|NCT01083043|"~     It is well known that lowering average blood glucose decreases the risk of diabetic~     complications involving the small vessels, such as those found in the eyes, nerves and~     kidney. It is less clear however, if controlling fluctuations in blood glucose will further~     help to prevent such complications.~      The purpose of this study is to examine the relationship between extreme fluctuations in~     glucose and damage to the blood vessel lining.~   "
189581|NCT01083030|"~     The aim of the study is correlating efficacy of the treatment to the proportion of~     paclitaxel-dose supplied by the catheter. Forty-five patients each will be treated by~     paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study~     centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in~     the superficial femoral or popliteal artery, main exclusion criteria are related to the use~     of paclitaxel and the need for follow-up examinations. Either clinical or angiographic~     follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary~     endpoint is 6-month angiographic late lumen loss. Secondary endpoints are further~     angiographic and clinical efficacy and various safety criteria.~   "
189582|NCT01083017|"~     The purpose of this study is to investigate the epidemiology of resistant hypertension,~     evaluate the efficacy and feasibility of a standardized drug treatment regimen (including the~     randomization of two doses of the diuretic used - chlorthalidone), study two interventions in~     the group of patients that is non-compliant, and study environmental and genetic variables of~     individuals with resistant hypertension in a family design.~   "
189583|NCT01083004|"~     A study of non-inferiority design comparing brilliant blue and indocyanine green as~     intraoperative dye in macular pucker and macular hole.~   "
189594|NCT01082861|"~     Rationale:~      In march 2009 the Dutch Health Council advised to introduce general infant hepatitis B (HBV)~     vaccination in the Dutch national immunization program (NIP) {Gezondheidsraad 2009 #16914}.~     To reach the anticipated health benefits earlier, a catch-up vaccination in pre-adolescents~     should complement the program, for girls preferably combined with human papillomavirus (HPV)~     vaccination at the age of 12 years. Although the rationale is clear, particular aspects of~     combining HPV and HBV vaccination deserve further attention, especially as it has been shown~     that combining HPV and HBV vaccination results in reduced HBV immunogenicity/seroresponses~     {Wheeler, Bautista, et al. 2008 #17284}{Pedersen 2009 #16684}. The reason for this~     interference is unknown, but might be due to concomitant use of different antigens and/or~     adjuvants, possibly skewing immunity in opposite directions. Despite proven immunostimulatory~     effects, the use of (new) adjuvants has raised safety concern among the general public as~     well {Israeli, Agmon-Levin, et al. 2009 #16924}.~      Objective, Study design and Study population:~      In view of the observations and concerns mentioned above, further investigation into~     interference of HPV and HBV vaccination and adjuvant use is justified. In this context RIVM~     propose to study single vs simultaneous HBV and HPV vaccination in 11-12-year-old girls while~     monitoring antigen-related and antigen-unrelated immunological parameters. The anticipated~     results will elucidate the extent of interference between simultaneous HPV and HBV~     vaccination in the target group, and guide the choice for a HBV vaccine and schedule when the~     HBV catch-up program is indeed introduced. Furthermore, specific immunological trends post~     single and combined HPV and HBV vaccination will be elucidated, increasing the investigators~     comprehension of adjuvant use.~   "
190362|NCT01072760|"~     The objective of this report is to describe a new surgical technique for the treatment of~     bony mallet finger which involves the application of both Kirschner wire and pull-out wire~     fixation. It is believed to decrease the risk of the complications.~   "
189584|NCT01082991|"~     The purpose of this study is to evaluate the accuracy of medical personnel in their ability~     to predict the likelihood of non-intensive care (ICU), ward patients to clinically~     deteriorate (defined as a cardiac arrest, unplanned ICU transfer, or unexpected death)via the~     use of a clinical judgement-based tool designed for this study, Patient Acuity Rating (PAR),~     to predict short-term clinical deterioration. We will compare the ability of this tool to~     predict clinical deterioration compared to accepted physiology-based tools and tools~     combining judgment and physiology as well as other markers of deterioration such as physician~     order changes. We will compare the sensitivity, specificity and area under the curve of these~     combined models to the predictive models including only physiology or clinical judgment. We~     will assess the correlation between specific physician orders and patient deterioration to~     determine whether specific clinical activities, such as emergently obtained radiology exams,~     predict impending deterioration. We hypothesize that PAR will be a useful tool for predicting~     clinical deterioration across the institution and that it will have a higher average accuracy~     for predicting clinical deterioration in non-ICU inpatients within 24 hours than the~     physiology-based tools alone. We further hypothesize that a combined metric which includes~     both the PAR and the individual physiologic components that comprise physiologic tools will~     not significantly improve prediction over the PAR alone. We further propose to use PAR to~     prospectively risk stratify patients for preemptive evaluation by the Rapid Response Team. We~     hypothesize that intervening on high risk patients by preemptively activating the hospital's~     Rapid Response Team (to assess and treat patients as needed) will decrease cardiac arrest~     rates and mortality.~   "
189585|NCT01082978|"~     The PHF trial will assess the acceptability and long term outcomes resulting from the usage~     of electronic (carried by the patient on a USB memory device) and paper portable health files~     in a population with high intensity use of medical services. The rationale is that use of the~     portable health files provides a conduit of direct communication among health care providers~     of a patient's important health care information and this leads to better care and patient~     outcomes.~      Primary hypothesis: Addition of a patient-held portable health file (PHF) to usual care~     improves patient outcome and quality-of-life compared to usual care alone.~      Secondary hypothesis: Addition of patient-held portable health file (PHF) to usual care is~     acceptable and satisfactory to patients and their health care providers.~   "
189586|NCT01082965|"~     The study hypothesizes that donepezil will have a positive impact on brain blood flow~     deficits in subjects with memory deficits and/or mild dementia and that improvements in brain~     blood flow will be accompanied by improvements in memory.~   "
189587|NCT01082952|"~     Being a key player in Asthma, eosinophils constitute a potential target to interfere with the~     series of biological events leading to Asthma pathogenesis. In this proposal, the~     investigators hypothesize that the interaction between eosinophils and airway smooth muscle~     cells (ASM) cells plays an important role in airway remodeling. Hence the investigators will~     investigate the role of eosinophils in enhancing ASM cells proliferation resulting in airways~     remodeling. The investigators will also investigate the mechanism behind this phenomenon.~     This will then pave the way for medical (drug) interference at one or several sites in order~     to prevent one of the main potential reasons behind airway remodeling, namely~     eosinophil-derived ASM proliferation.~   "
189588|NCT01082939|"~     The goal of this clinical research study is to learn if the combination of fludarabine,~     cyclophosphamide, alemtuzumab, and rituximab is effective in treating chronic lymphocytic~     leukemia in patients who have already been treated with chemotherapy.~      Primary Objectives:~      Evaluate the therapeutic efficacy, including the complete remission (CR), nodular partial~     remission (NPR), and partial remission (PR) rates (overall response) of combined~     cyclophosphamide, fludarabine, alemtuzumab, and rituximab (CFAR) in previously treated~     patients with Chronic Lymphocytic Leukemia (CLL).~      Second Objectives:~        -  Assess the toxicity profile of CFAR in previously treated patients with CLL.~        -  Monitor for infection and determine incidence and etiology of infection including~          cytomegalovirus in patients treated with CFAR.~        -  Evaluate molecular remission by polymerase chain reaction (PCR) for the clonal~          immunoglobulin heavy chain variable gene in responding patients treated with CFAR.~        -  Assess immune parameters, including pretreatment, during treatment, and post-treatment~          blood T-cell counts and subset distribution and serum immunoglobulin levels in patients~          treated with CFAR.~   "
189589|NCT01082926|"~     RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the~     immune system in different ways and stop tumor cells from growing. Donor T cells that are~     treated in the laboratory may be effective treatment for malignant glioma. Aldesleukin may~     stimulate the white blood cells to kill tumor cells. Combining different types of biological~     therapies may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best way to give therapeutic~     donor lymphocytes together with aldesleukin in treating patients with stage III or stage IV~     malignant glioma.~   "
189590|NCT01082913|"~     The purpose of this study is to determine whether sacral surface electrical stimulation is~     effective in the treatment of assisted reproductive technology.~   "
189591|NCT01082900|"~     Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid~     and a common cause of admission of full term infants and late pre term infants (34 to 36~     weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at~     delivery, and mode of delivery are considered risk factors for TTN. The investigators~     hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based~     infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the~     incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot~     study to evaluate the prophylactic administration of CPAP in the Delivery Room towards~     prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a~     randomized control trial after obtaining informed consents from the parents of eligible~     infants. Infants will be randomized to receive either experimental treatment (prophylactic~     CPAP) or standardized care.~   "
189592|NCT01082887|"~     The main objective of this study is to evaluate the clinical and biologic toxicity of cell~     therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg.~   "
190395|NCT01072331|"~     The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in~     patients with type 2 Diabetes for 4 weeks administration.~   "
189595|NCT01082848|"~     Evidence is lacking on the effects of different psychotropic drugs in the treatment of~     anorexia nervosa (AR). However, HVA levels seem to be elevated in this disease, therefore~     suggesting a role for drugs with a partial agonist profile on dopaminergic receptors. This is~     a pilot study assessing the effects of aripiprazole in teenagers with AR, compared with a~     placebo.~   "
189596|NCT01082835|"~     Jangzhuo Qinggan prescription and irbesartan in the treatment of essential~     hypertension(Hepatogastric Damp-heat), randomized, parallel-controlled, multi-center clinical~     study.~   "
189597|NCT01082822|"~     Cell sheet technique possess the properties of conserving the ECM, rich molecules and~     retaining cell vitality, and will promote the capacity of cell adhesion and proliferation.~     The stem cell based cell sheet therapy has been utilized in many fields and scored the~     satisfactory results. Periodontitis is a chronic disease which causes the destruction of the~     periodontal tissue and leads to the teeth loss in the end. The routine cell-based therapy to~     the periodontitis was confronted with many difficulties. In the investigators previous~     preclinical research, +the investigators fabricated periodontal ligament stem cell (PDLSC)~     pellets and cell sheet fragment and applied them in the periodontal defect area for tissue~     regeneration and periodontitis treatment. And the investigators carried out a comprehensive~     study of the PDLSC allograft. The host responses and implanted cell fates were recorded.~     After the scientific investigation of the preclinical study, the investigators designed the~     preliminary clinical trial of PDLSC cell sheet for the chronic periodontitis therapy in the~     aims to test the PDLSC fates and explore one ideal transplantation mode.~   "
189598|NCT01082809|"~     The purpose of this study is to determine whether sunitinib as second-line treatment in~     advanced biliary tract carcinoma~   "
189599|NCT01082796|"~     Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million~     peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is~     Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type~     2 disease. Little information has been presented for the relationship between CYP2C19 genetic~     polymorphism and glipizide, since recently the investigators reported that there existed a~     tendency. In this study the investigators found that CYP2C19 polymorphism significantly~     influenced the pharmacokinetics of glipizide.~   "
189600|NCT01082783|"~     The damage of the brain parenchyma, as well as the stroke-induced dysfunction of the~     blood-brain-barrier can make previously hidden CNS antigens visible, and can thus lead to~     the development of autoimmune mechanisms.~      It seems plausible that stroke-associated immunodepression influences the development and the~     phenotype of these autoreactive immune responses.~      This study will investigate whether cerebral ischemia leads to changes in the immune~     response, in particular to the development and/or proliferation of autoreactive effector~     T-cells and/or regulatory T-cells. Furthermore, the association between the severity and the~     phenotype of this autoimmune response and the clinical course, i.e. prognosis and mortality,~     will be investigated.~   "
189601|NCT01082770|"~     This study will be a randomised controlled trial examining whether a new type of needle free~     access device(TEGO) is associated with less episodes of infection of dialysis lines, when~     compared to the current gold standard.~      The investigators hypothesise that there will be less handling of the dialysis line by~     nursing staff and thus this will lead to lower rates of infection. The investigators will~     also assess whether these access devices lead to alterations in catheter blood flow rates~     when compared to the current gold standard.~   "
189602|NCT01082757|"~     This observational, prospective, multicentric study is being conducted to record the~     prevalence of KRAS mutations in the Argentine mCRC population.~   "
189603|NCT01082744|"~     The use of paravertebral catheters is a recommended technique to achieve postoperative~     analgesia after thoracic surgery. To date there is no consensus on which drug regime (local~     anesthetics with or without opioid) is best. The aim of this prospective clinical trial is to~     determine wether the use of ropivacaine and sufentanil injected through a thoracic~     paravertebral catheter results in decreased acute postoperative pain compared with plain~     ropivacaine in patients after thoracoscopic lung surgery.~   "
189604|NCT01082731|"~     Data on the burden of MIP in low transmission areas, such as Latin America, are very limited;~     there is even less information on the efficacy of case management of MiP. The treatment~     recommendations for MiP in Latin American countries have been changing rapidly in recent~     months; currently, either artemether-lumefantrine (AL) or mefloquine-artesunate (MA) is the~     first line treatment for P. falciparum (depending on country); however, no data exists on the~     efficacy of these drugs for the treatment of malaria in pregnancy in Latin America to support~     their use.~      We propose a multi-center 2-arm open-label randomized Phase 4 clinical trial to assess safety~     and efficacy of the present therapies, AL and MA. We hypothesize that the drugs will both be~     efficacious for use in pregnant women in Brazil.~   "
189605|NCT01082718|"~     Artemisinin-based combination therapies (ACTs) are now the treatment of choice for malaria in~     non-pregnant individuals living in areas with established chloroquine resistance; they have~     been shown to be both safe and highly efficacious. There is rapidly increasing experience~     with artemisinin derivatives in the 2nd and 3rd trimesters of pregnancy, with over 1,000 well~     documented cases with no reported serious adverse effects to mother or fetus (WHO Malaria~     Treatment Guidelines, 2006). Many countries in Latin America have abandoned the previous 1st~     line regimen of Quinine-Clindamycin for treatment of malaria in pregnancy, a complex and~     poorly tolerated regimen with low adherence, in favor of ACTs, despite limited safety and~     pharmacokinetic data on the use of these compounds in pregnant women. Lack of pharmacokinetic~     data may lead to underdosing of pregnant women, with subsequent reduced efficacy and~     increased potential for development of resistance.~      One ACT regimen, Artesunate-Mefloquine, has been developed as a fixed-dose combination~     (Farmanguinhos Artesunato + Mefloquina), as part of an international collaborative research~     effort led by Drugs for Neglected Diseases Initiative (DNDi), and manufactured by~     Farmanguinhos, laboratory of the Brazilian Ministry of Health. Initial clinical trials~     suggest that it is very well tolerated and efficacious in both pregnant and non-pregnant~     individuals. The convenient dosing afforded by a fixed drug combination make this a very~     promising candidate for treatment of pregnant women with malaria. Preliminary pharmacokinetic~     data from mefloquine monotherapy and prophylaxis suggest that the peak concentration of~     mefloquine is lowered in pregnant women. Prior to wide-spread adoption of the~     Artesunate-Mefloquine combination, further studies on safety, efficacy, and dose optimization~     are imperative. We propose to compare the pharmacokinetics of the fixed combination of~     mefloquine-artesunate (MA) for treatment of P.falciparum in 28 pregnant women in the second~     and third trimesters to the pharmacokinetics of this regimen in 28 matched non-pregnant~     P.falciparum infected women. This will allow us to determine whether the standard adult dose~     is sufficient for pregnant women.~   "
189617|NCT01082562|"~     The purpose of this study is to assess the safety, tolerability, serum concentrations and~     pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and~     multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in~     subjects with elevated cholesterol (MAD).~   "
189606|NCT01082705|"~     Following the rapid development of significant drug resistance to both chloroquine and~     sulfadoxine-pyrimethamine (the first line therapy in Tanzania from 2001 -2006), artemether-~     lumefantrine (Coartem or AL) was adopted as first line therapy in Tanzania in 2006. Now that~     this drug has been widely used for some time, the investigators propose to conduct an~     antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if~     this drug remains efficacious, or if significant resistance has emerged, in which case a new~     antimalarial strategy will need to be contemplated. The investigators hypothesize that the~     efficacy of Artemether-lumefantrine remains high, and that the other artemisinin combination~     therapies will be equally efficacious.~      Children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated~     with either artemether + lumefantrine (Coartem) or dihydroartemisinin-piperaquine~     (Duo-Cotecxin or Artekin). Clinical, parasitologic, and hematologic parameters will be~     monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.~   "
189607|NCT01082692|"~     DNA vaccines consist of small pieces of DNA also known as plasmids, and have several~     potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well~     tolerated in humans. We have developed DNA vaccine, PENNVAX-B, which includes plasmids~     targeting the gag, pol, and env proteins of HIV-1. The vaccine will be delivered via~     electroporation (EP) which uses the CELLECTRA constant current device to deliver a small~     electric charge following injection, since animal studies have shown that this delivery~     method increases the immune response to vaccine. The vaccine will be given to HIV-1 infected~     subjects whose viral load is undetectable on a HAART regimen, with CD4 lymphocyte count above~     400 cells/µL of blood. It is hypothesized that PENNVAX-B + EP will be safe and well~     tolerated.~   "
189608|NCT01082679|"~     This pilot study is examining the feasibility of a primary care and a specialist treatment~     (methadone clinic) model of treatment for 15 offenders who are part of two community~     supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County.~     The questions addressed by future larger studies based upon the current pilot-feasibility~     study will center around whether access to primary health care as opposed to more traditional~     methadone treatment services will improve the health and criminal justice outcomes for~     participants.~   "
189609|NCT01082666|"~     We hypothesized that continuous control of tracheal cuff pressure would reduce~     microaspiration of gastric content as determined by pepsin level in tracheal aspirate.~   "
189610|NCT01082653|"~     A Phase I, single center, prospective, non-randomized, open label, safety/efficacy study of~     the infusion of autologous bone marrow-derived stem cells, in 6 patients with Amyotrophic~     Lateral Sclerosis according to established criteria (1), (2) with a moderate to severe~     diagnosis of ALS according to the World Federation of Neurology El Escorial criteria.~      The primary purpose of this study is to evaluate safety of the infusion procedure, as~     assessed by absence of complications at the site of infusion or the appearance of new~     neurologic deficit not attributed to the natural progression of the disease.~      Secondary outcomes will include a)neurological evidence of trends toward a slowing down of~     the decline of the forced vital capacity (FVC) (3) and of the functional rating scale~     (ALS-FRS) scores, as assessed at 3-month intervals, b)evidence of a decline of the maximum~     voluntary isometric contraction-arm (MVIC-arm) and MVIC-grip Z (4) scores and c)patient~     evaluation that the treatment was effective and consider the possibility of a new cell~     product stem cell infusion.~      Subjects who fulfill inclusion/exclusion criteria and sign informed consent will undergo an~     aspiration of bone marrow from the iliac crest for preparation of the cellular product.~      The day of infusion, the investigational product will be injected into the patient's~     intrathecal space.~      After cell infusion patients will be followed at WK 2, MN 1, MN 2, MN 6 and a long-term~     followup at MN 12 in the clinic and/or office. Electromyographic (EMG) studies, Forced vital~     capacity (FVC), functional rating scale (FRS) and maximum voluntary isometric contraction-arm~     (MVIC-arm) and MVIC-grip Z scores will have been used to assess the status of the disease~     before (historical record acceptable if done within three months of Screening Visit) and~     during the 12-month study period after cell infusion.~   "
189611|NCT01082640|"~     The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice~     daily (BID), on renal function in gout patients with elevated serum urate levels and who have~     moderate to severe renal impairment.~   "
189612|NCT01082627|"~     Primary Objective:~      To demonstrate whether an early fixed Somatostatin treatment improves the complete recovery~     rate of early postoperative simple small bowel obstruction (EPSSBO) compared with the common~     daily practice~      Notes:~        1. complete recovery= toleration of solid food+ flatus+ passage+ recovery of bowel~          movement.~        2. common daily practice includes:~             -  NPO (Nil per mouth), re-dehydration, TPN (Total Parenteral Nutrition) if needed.~               Check & make sure stability of electrolytes daily.~             -  GI (Gastro-Intestinal) depression via NGT (Naso-Gastric Tube)~             -  Discontinue opiates, instead of NSAIDs. (Non-Steroidal Anti-Inflammatory Drugs)~             -  Pro-dynamic drugs or other drugs which may interfere with GI (Gastro-Intestinal)~               movement eg. anti-histamines, anti-cholinergic, opiates, anti-depressives are not~               indicated.~      Secondary Objectives:~      To investigate whether an early fixed Somatostatin treatment will bring much benefit to~     EPSSBO pts compared with the common daily practice,for this purpose,the study will~     investigate the endpoints below.~   "
189613|NCT01082614|"~     This study evaluates whether using information from a special arterial blood pressure monitor~     to guide how much fluid is given during surgery changes how long a patient stays in the~     hospital after the surgery. There is scientific evidence from using similar information from~     different devices that this technique might allow us to do a better job giving fluids during~     surgery and that this may be associated with shorter hospital stay after surgery.~   "
189614|NCT01082601|"~     To compare heart function, symptoms, exercise capacity and quality of life in patients with~     Congestive Heart Failure (CHF) and Atrial Fibrillation (AF)before and after catheter~     ablation.~      Hypothesis: Restoration and maintenance of sinus rhythm by catheter ablation, without the use~     of antiarrhythmic drugs, in AF and CHF improves heart failure status.~   "
189615|NCT01082588|"~     This study involves people with schizophrenia or schizoaffective disorder, who are currently~     taking antipsychotic medications. Some antipsychotic medications may cause an increase in~     cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in~     developing heart disease, diabetes and problems with brain function. The purpose of this~     study is to see if pravastatin can:~        -  Lower cholesterol~        -  Decrease inflammation~        -  Improve cognition in patients with schizophrenia~   "
189616|NCT01082575|"~     The pain medication given after major surgery may cause some patients to stop breathing for~     periods of time especially at night time. An oxygen monitor may reflect this abnormal~     breathing pattern. This is an observational study of 100 post-operative patients who will be~     monitored with a pulse oximeter for a minimum of two nights and a maximum of five nights to~     determine the prevalence of this abnormal breathing pattern.~   "
189618|NCT01082549|"~     To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer~     receiving the combination of gemcitabine/carboplatin either with or without Iniparib.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
189619|NCT01082536|"~     The purpose of this study is to use an experimental diagnostic tool(NIRS), combined with a~     known screening tool (cranial ultrasound), to analyze and evaluate cerebral blood flow and~     oxygenation, and determine if abnormal neurodevelopmental outcomes can be predicted and~     potentially improved upon in pediatric patients undergoing repair for congenital heart~     disease.~   "
189620|NCT01082523|"~     The purpose of this study is to determine whether an automated electronic reminder system~     using text messages sent to patient's cell phones will help patients with acne be more~     compliant with their topical medications and lead to an improvement of their acne.~      Hypothesis: Automatically delivered electronic reminders in the form of text messages will~     increase acne patient adherence to topical medications and consequently result in better~     treatment outcome and higher patient satisfaction~   "
189621|NCT01082510|"~     The purpose of this prospective randomized controlled study is to prove the non-inferiority~     of UFT maintenance therapy to BCG maintenance therapy for preventing recurrences of~     superficial bladder cancer.~   "
189622|NCT01082497|"~     The purpose of this study is to investigate whether a mindfulness based 8-week course for~     stress reduction, known as MBSR course, given to all staff at an inpatient psychiatric ward~     influences the level of stress and burnout and the psychosocial atmosphere at the ward.~      The design is an intervention trial with repeated measures and control group.The focus is the~     interaction between unit and individuals.~      All staff at both wards were invited to participate. The intervention consists of 8 weekly~     group meetings where the participants learn different ways of practicing mindfulness and do~     home practice between the meetings. The control intervention is 8 weekly workshops in~     affect-consciousness.~      Data are collected through self-reporting questionnaires on mindfulness, work- and~     health-related topics at six different points. The patients at both wards answers one~     questionnaire about ward atmosphere at the same points.~      Data wil be analyzed on SPSS statistic programme.~   "
189623|NCT01082484|"~     The purpose of this study is to test whether prostacyclin analogues' cathodal iontophoresis~     induce a cutaneous vasodilation in healthy volunteers's forearm, without local side effects.~   "
189624|NCT01082471|"~     To compare the incidence and severity of nausea in the study treatment groups, during the~     18-hour period starting 6 hours after titration to pain relief; following confirmation of the~     assumption of non-inferiority between the two groups of pain relief over the 24 hour~     post-operative period. Pain relief and nausea will be determined by measuring the areas under~     the curves of pain intensity and nausea verbal rating scale scores.~   "
189625|NCT01082458|"~     Target concentration infusion(TCI) of remifentanil (2.0ng/ml) suppresses the cough induced by~     endotracheal tube more effectively than intravenous administration of lidocaine (1.5mg/kg).~   "
189626|NCT01082445|"~     The purpose of this study is to determine whether N-acetylcysteine is effective in the~     treatment or prevention of the foot ulcers in diabetic patients.~   "
189627|NCT01082432|"~     Background~      One of the potentially debilitative complications of operative repair and subsequent~     immobilization is stiffness that appears secondary to inflammation and adhesions. To prevent~     such a physical impairment, active joint mobilization has shown to be efficient. However,~     adhesions sometimes remain despite the therapy. Due to the viscoelastic nature of the~     biological tissues, if a technique can enable to extend the muscle ability to impose a~     maximal steady stress on adhesions, adhesion deformation should be greater and range of~     motion deficit should be reduced. Within that context, the purpose of the present study was~     to assess the real-time effects of superimposed electrical stimulation (SES) on maximal~     voluntary muscular contraction (VOL) over time and to assess SES effects on range of motion~     recovery in thumb stiff joint.~      Methods and Findings~      The aim of the first experiment was to examine the real-time effects of tetanic SES on the~     maximal volitional level of force over repeated contractions of the triceps brachii muscle.~     To address this goal, seventeen subjects participated voluntarily in this study. Two features~     of the muscular force were assessed: The peak force (1) and the impulse (2). These two~     dependent variables were measured during 500 sec - including 50 maximal force productions of~     4 sec each- in two randomized conditions of VOL and SES. When considering the 50 trials as a~     whole, exerted force was higher in the SES than in the VOL condition for both peak force and~     impulse (P<.05). Over time, peak force and impulse decreased consistently in VOL starting~     between the 20th and 30th trials whereas they were maintained in SES condition (P<.05).~      The aim of the second experiment was to compare the effects of VOL and SES on the range of~     flexion recovery of the stiff metacarpophalangeal joint following operative repair of the~     ulnar collateral ligament of the thumb. To address this goal, eight patients participated~     voluntarily. Range of motion, oedema and pain were assessed before and after the two~     randomised conditions of VOL and SES.~   "
189628|NCT01082419|"~     Liver stiffness measurement (LSM) by non invasive methods is increasingly used to estimate~     liver fibrosis in patients with chronic liver diseases. However, there is growing evidence~     that fibrosis is not the only determinant of liver stiffness. Indeed inflammation,~     cholestasis, congestion could also interfere with stiffness measurements. Acoustic radiation~     force impulse imaging (ARFI) is a new technology to perform real time LSM. Using a standard~     ultrasonographic probe, it offers elastography with a flexible metering box at variable~     depth, allowing the examination of specific area.~   "
189629|NCT01082406|"~     This trial is conducted in Europe. The aim of this clinical trial is to compare the~     metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different~     manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.~   "
189630|NCT01082393|"~     We will investigate the process of vitiligo induction and the influence of different commonly~     used cream treatments on this process. Studies comparing different treatments for vitiligo in~     the induction stage of the disease are still missing. The study hypothesis = cream treatment~     can stop actively spreading vitiligo lesions during the early induction stage of the disease.~   "
189631|NCT01082380|"~     The rationale for this study is to investigate the absorption, metabolism and excretion of~     [14C]PF 02341066 and characterize plasma, fecal and urinary radioactivity, and identify any~     metabolites, if possible, of [14C]PF 02341066 in humans.~   "
189632|NCT01082367|"~     This study investigated the efficacy of inhaled TOBI treatment for early infections of P.~     aeruginosa in paediatric patients with cystic fibrosis.~   "
189636|NCT01082315|"~     After consultation with the Korean Health Authorities, the two Post-Authorization Safety~     Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one~     study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is~     requested by the Korean Health Authorities to continue monitoring of Erbitux and provide~     further information about safety and toxicity in clinical practice in at least 900 patients~     during 6 years.~      All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain~     unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately~     disclose the EMR 062202-551 study titled A Korean Post-Marketing Surveillance Study On~     Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic~     Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With~     EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509) on~     clinicaltrials.gov.~   "
189637|NCT01082302|"~     This open, monocentric study is designed to investigate plasma concentrations of certain~     catechins after topical application of Veregen 15% ointment to genital or perianal warts in~     comparison to catechin plasma concentrations after oral intake of a defined dose of green tea~     beverage. The study is intended to demonstrate that topical administration of Veregen 15%~     induces catechin plasma concentrations lower or equivalent to those that can be reached with~     normal consumption of green tea.~   "
189638|NCT01082289|"~     The objective of this study is to evaluate the pharmacokinetic profile of digoxin when~     administered alone and when administered with repeated dose of lurasidone 120mg.~   "
189639|NCT01082276|"~     The effect of rifampin on the pharmacokinetics of lurasidone~   "
189640|NCT01082263|"~     A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.~   "
189641|NCT01082250|"~     A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl~   "
189642|NCT01082237|"~     Major depressive disorder (MDD) is a common psychiatric illness with high cost to society and~     individual patients. One reason for the high cost is that most patients endure lengthy and~     ultimately unsuccessful empiric antidepressant trials before a successful medication is~     identified by trial-and-error. Care would be improved if a biomarker could determine, early~     in the course of treatment, whether a particular antidepressant would likely lead to~     response, remission, or treatment failure. Physicians could rapidly change treatments to an~     antidepressant which the biomarker indicated would be likely to help the patient. We have~     identified quantitative electroencephalographic (QEEG) changes that emerge early in the~     course of treatment with selective serotonin reuptake inhibitors (SSRIs) that appear to~     predict later response and remission in a general adult patient population. Demographic~     trends in the United States suggest that improved care for MDD will be essential for a~     growing number of elderly with late-life depression. While the consequences of prolonged~     trial-and-error periods to find a successful treatment are particularly inauspicious for~     elders with late-life depression, this patient group has not been included in the past~     studies which demonstrated the use of this biomarker approach in a general adult population.~     We propose a 12-week treatment trial to evaluate a practical biomarker for predicting outcome~     based on data from the first week of antidepressant treatment, with a focus only on~     depression in late life (age ≥65).~      There are three study Hypothesis:~      H1) ATR prediction of treatment outcome in older subjects will show >70% accuracy.~      H2) The predictive accuracy of the model will be enhanced by including clinical,~     socio-demographic, and genetic predictors.~      H3) The accuracy of ATR prediction will not show a significant dependence on subject gender.~   "
189643|NCT01082224|"~     RATIONALE: Diagnostic procedures, such as contrast-enhanced CT scan and contrast-enhanced~     MRI, may help find liver cancer and find out how far the disease has spread.~      PURPOSE: This clinical trial is studying contrast-enhanced CT scan and contrast-enhanced MRI~     in diagnosing and staging liver cancer in patients with chronic liver disease.~   "
189644|NCT01082211|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy after surgery kill any remaining tumor cells and may be an effective treatment for~     breast cancer.~      PURPOSE: This phase II trial is studying how well radiation therapy works in treating women~     with locally recurrent breast cancer previously treated with repeat breast-conserving~     surgery.~   "
189645|NCT01082198|"~     RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person's tumor~     cells may help the body build an effective immune response to kill tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma~     vaccine in treating patients with stage III melanoma after surgery to remove the lymph nodes.~   "
189646|NCT01082185|"~     A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal~     Stent Graft System~   "
189647|NCT01082172|"~     A prospective, non-randomized multi-center clinical evaluation of the performance of the~     TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic~     aortic aneurysms (TAA).~   "
189648|NCT01082159|"~     This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar~     Decompression with the Mild® devices in patients with symptomatic central canal spinal~     stenosis.~   "
189649|NCT01082146|"~     This will be an open-label, non-randomized, absorption, metabolism, and excretion study of~     Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a~     postprandial state~   "
189650|NCT01082133|"~     The trial proposed is a multicenter treatment protocol designed to examine transplant related~     events in patients with Fanconi anemia who lack matched sib donors have severe aplastic~     anemia (SAA), or myelodysplastic syndrome(MDS) or acute myelogenous leukemia (AML).~   "
189651|NCT01082120|"~     The purpose of this study is to determine whether administration of AZD1656 will affect the~     pharmacokinetics of Pioglitazone and vice versa in patients with Type 2 Diabetes Mellitus.~   "
189652|NCT01082107|"~     SODISWATER is a European Union funded health impact assessment study investigating the effect~     of sunlight to inactivate microbial pathogens in drinking water. This study was done by~     observing whether children younger than 5 years old who drink solar disinfected water were~     healthier than those who did not. Health was measured by how often the children had~     diarrhoea.~      Participants were given plastic bottles to place in the sun, water samples were then~     collected from these plastic bottles to be analyzed. They were also requested to fill in~     diarrhea diaries.~      TESTABLE RESEARCH HYPOTHESES:~      Health Impact Assessment: Children who use solar disinfected water will have:~      (a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth~     rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden~     (g) increased school attendance~   "
189653|NCT01082094|"~     The purpose of this Phase 1 study is to assess the safety, tolerability, and preliminary~     efficacy of single escalating doses of ACRX-100 delivered via endomyocardial injection in~     adults with ischemic heart failure.~   "
189654|NCT01082081|"~     GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol~     1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic~     efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The~     duration of the entire study will be approximately 16 weeks. Each subject will have to come~     to the clinic for three visits (Screening, Treatment and Follow up visits).~   "
189655|NCT01082068|"~     Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in~     combination with letrozole (Femara) and of XL765 when given in combination with letrozole.~     After the MTD is established for each combination (Phase 2), subjects will be enrolled to~     evaluate the preliminary efficacy and safety of these combinations in subjects with breast~     cancer refractory to a non-steroidal aromatase inhibitor that is ER+/PGR+ and HER2-.~     Letrozole is used in the treatment of different types of breast cancer, but patients can~     develop resistance.~      Upregulation of PI3K activity is one of the most common characteristics of human cancer~     cells, including breast tumor cells. Activation of PI3K results in stimulation of AKT and~     mTOR kinases, resulting in the promotion of tumor cell proliferation and survival.~     Preclinical and retrospective clinical data suggest that aberrant activation of the PI3K~     pathway may play a role in aromatase inhibitor resistance in patients with ER+, HER2- breast~     cancer. XL147 is a potent inhibitor of PI3K, and XL765 is a potent dual inhibitor of PI3K and~     mTOR; therefore either of these compounds in combination with letrozole warrants clinical~     investigation.~   "
189656|NCT01082055|"~     Antiarrhythmic drugs are associated with significant side effect profiles. Amiodarone has~     primarily class III action and whilst it has unrivalled efficacy in management of certain~     arrhythmias, it has a formidable side effect profile. Complications of continued therapy~     include, thyroiditis, hepatitis, cholestasis, increased skin sensitivity and pulmonary~     fibrosis. Current prescribing guidelines recommend frequent blood tests to monitor kidney,~     liver and thyroid function, in addition to frequent pulmonary function tests. Sotalol is a~     betablocker which possesses class III action in high doses and may predispose to QT~     prolongation Other class I agents such as flecainide and propafenone can be associated with~     sudden cardiac death in certain populations, and may predispose to other arrhythmias.~      This study will examine the incidence of discontinuation of AAD therapy and adverse events.~   "
189657|NCT01082042|"~     This is a pilot study to assess whether balance training with the Nintendo® Wii is comparable~     to a physiotherapist−led falls group in terms of improvement in balance. The acceptability of~     the Nintendo® Wii will also be assessed.~   "
189658|NCT01082029|"~     The accumulation of fluid behind the ear drum without any acute inflammation is known as~     otitis media with effusion (OME). It is the most common cause of acquired hearing loss during~     childhood. Long-term complications of OME include linguistic, developmental, and social~     development delays due to hearing loss.~      The cause of OME is not known; however, low grade infection of the middle ear, poor function~     of the eustachian tube between the ear and the throat, and adenoid hypertrophy have all been~     suggested as possible etiologies. Recent detection of the stomach enzyme pepsin in middle ear~     fluid has led some to propose that OME is related to the reflux of stomach contents into the~     ear, via the eustachian tube.~      The purpose of the investigators study is to determine whether anti-reflux medication may~     have a positive impact by clearing the accumulation of fluid in the middle ear with the aim~     of preventing or reducing hearing loss in children diagnosed with OME. Empiric anti-reflux~     therapy with proton pump inhibitor (PPI) medication is safe, proven and cost-effective. It is~     used widely as a diagnostic and treatment strategy in the presence of the signs and symptoms~     of gastroesophageal reflux disease (GERD). The signs and symptoms of GERD include heartburn,~     recurrent vomiting or regurgitation, acid taste in mouth, throat irritation, voice problems,~     heartburn, difficult or painful swallowing, asthma and recurrent pneumonia.~      This pilot study will be a double-blinded, randomized, placebo-controlled trial that will~     compare resolution rates for OME in children treated with lansoprazole or placebo for three~     months. At the end of the study, those patients who have persistent middle ear effusions will~     be brought to the operating room and have the fluid aspirated and sent for analysis for~     pepsin.~   "
189659|NCT01082016|"~     Sleep deprivation in healthy volunteers is associated with immune dysfunction. This adverse~     effect of sleep deprivation likely occurs in patients suffering from acute injury and~     critical illness requiring intensive care unit (ICU) admission. Studies have demonstrated~     that sleep in ICU patients is highly abnormal. The global hypothesis for this proposal is~     that a strategy to promote sleep in ICU patients will increase time in rapid eye movement~     (REM) and slow wave sleep (SWS). This three phase proposal examines the feasibility of a~     sleep promotion strategy for injured and critically ill patients in the ICU.~      Phase I (Development and Training): Develop an intervention manual for sleep promotion, Sleep~     Enhancement Program (SEP), and train ICU staff.~      Phase II (Validation and Safety): Implement SEP and test for protocol fidelity and safety.~      Phase III (Efficacy): Conduct a pilot trail to determine efficacy of SEP to improve SWS in~     ICU patients.~   "
189660|NCT01082003|"~     The main purpose of this research study is to determine if the use of Trental and Vitamin E~     will decrease the incidence and severity of contractures (shrinking and or hardening of~     tissue surrounding the implant) associated with breast implant reconstruction following~     radiation treatment. Another goal is to find out the impact that Trental and Vitamin E have~     on implant loss or need for surgical intervention in the setting of chest wall radiation~     after reconstruction. In addition, the investigators want to evaluate the patient's sense of~     well being and quality of life.~   "
189685|NCT01081678|"~     This is an international, multi-center, randomized, double-blind, placebo-controlled study to~     determine the efficacy, safety, and tolerability of AMG 785 in adults with a fresh unilateral~     hip fracture, status post surgical fixation.~      The primary hypothesis of this study is that AMG 785 compared with placebo is effective in~     accelerating healing of hip fractures and improving physical functioning, as measured by the~     TUG, for subjects with fresh unilateral low energy hip fractures, status post surgical~     fixation.~   "
189686|NCT01081665|"~     The aim of this post-marketing observational study is to obtain further data on the long term~     use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and~     according to the approved Summary of Product Characteristics for the treatment of secondary~     hyperparathyroidism in hemodialysis patients in Greece.~   "
189661|NCT01081990|"~     The management of post-operative pain in patients after vaginal surgery provides many~     unforeseen challenges. Although vaginal surgery is considered a minimally invasive approach~     for the repair of pelvic floor prolapse and urinary incontinence, patients may still~     experience varying degrees of discomfort and post-operative pain. Narcotics, however, can~     introduce a host of problems in addition to the potential addictive properties of the~     medication. A vicious cycle ensues as patients seek better pain control at the expense of~     worsening constipation, but without adequate control of pain after surgery, voiding~     dysfunctions are often exaggerated.~      Cyclobenzaprine (Flexeril®) in conjunction with NSAIDs has long been the basis for management~     of acute musculoskeletal injuries, but the practice of prescribing this centrally acting~     muscle relaxant for post-operative patients has also been successful in the management of~     pain.~      An online search of medical databases revealed that there are currently no published~     retrospective or prospective studies determining the efficacy of cyclobenzaprine in post~     surgical patients in conjunction with traditional pain management. The investigators~     hypothesize among healthy patients undergoing elective vaginal surgery for pelvic organ~     prolapse, the short-term use of a muscle relaxant could reduce the spasticity of the pelvic~     floor muscle attributable to surgery and thereby reduce the use of narcotics. Consequently,~     the reduction of narcotics and the control of post-surgical pain may also hasten the return~     of normal urinary and defecatory function.~   "
189662|NCT01081977|"~     In developing countries up to 50% of children become anemic by 12 months of age(1. Iron~     deficiency anemia is a major risk factor for neonatal and infantile mortality and morbidity~     in Pakistan. It has detrimental effects on neurodevelopment of infants and may be~     irreversible even after iron therapy(2). Type of cost effective interventions during~     perinatal period for prevention of anemia in later infancy is limited. Delayed cord clamping~     has a beneficial effect on prevention of anemia in later infancy because of increased iron~     stores at birth(3. However there are controversies in incorporating delayed cord clamping~     practice in the management of third stage of labour globally(4) Paucity of national~     guidelines and lack of substantial data in Pakistan on this topic strongly necessitates such~     study trials. This study may contribute to develop a protocol on the timing of cord clamping~     which will be cost effective in prevention of iron deficiency anemia in the investigators~     infantile population.~      The investigators will conduct a randomized controlled trial and the investigators hypothesis~     is that delayed cord clamping will result in higher hemoglobin (Hb), hematocrit (Hct) and~     ferritin at third month as compared to early cord clamping.~      OBJECTIVES:~      A- Primary:~        1. To study the effect of timing of umbilical cord clamping on hemoglobin (Hb), Hematocrit~          (Hct) at birth, 48 hours and Hb, Hct and ferritin at three months of age.~        2. To study the effect of timing of umbilical cord clamping on short term clinical profile~          of neonates like jaundice, respiratory distress, anemia, polycythemia etc. during fist~          24 to 48 hours of life.~      B- Secondary:~      To assess whether delayed cord clamping is associated with undesirable effects on mothers~     followed till 48 hours postpartum.~   "
189663|NCT01081964|"~     A double-blind, three-arm study, to evaluate the safety and efficacy of two dosing regimens~     of zabofloxacin (a fluoroquinolone antibiotic) in community acquired pneumonia.~   "
189664|NCT01081951|"~     To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4)~     when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian~     cancer.~   "
189665|NCT01081938|"~     Primary Objective:~      1- Proportion of patients with mean daily glycemia <140mg/dL during the period of 7 days of~     treatment with glargine plus supplemental glulisine versus patients with glulisine sliding~     scale.~      Secondary Objective:~        1. Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period.~        2. Incidence of hypoglycemia (<60mg/dL and < 40mg/dL) during the treatment period.~        3. Incidence of severe hyperglycemia (>400mg/dL) during the treatment period.~        4. Total dose of insulin and correction dose in each group.~   "
189666|NCT01081925|"~     The purpose of the study is to recognize main causes of acute decompensation of chronic~     congestive heart failure.~   "
189667|NCT01081912|"~     The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate~     controlled-release capsules in subjects with chronic low back pain.~   "
189668|NCT01081899|"~     The purpose of this study is to evaluate the effectiveness of the LCP-I Program in improving~     the quality of end-of-life care provided to cancer patients who die on hospital medical wards~     as compared to standard healthcare practices.~   "
189669|NCT01081886|"~     The objective of this clinical study is to evaluate the operative performance of the PEAK~     PlasmaBlade 4.0 during total knee replacement; to monitor and record post-operative pain,~     activity level, narcotic consumption, adverse events, and skin scarring following surgery;~     and compare these outcomes to the current standard of care (SOC).~   "
189670|NCT01081873|"~     Document treatment patterns and evaluate LUCRIN / LUCRIN-TRIDEPOT® (Leuprolide) and~     alternative therapeutic approaches to the treatment of advanced prostate cancer during normal~     clinical practice and in accordance with the terms of the Belgian marketing authorization and~     reimbursement conditions.~   "
189671|NCT01081860|"~     The exact etiology of CTS remains yet unknown. A rise in carpal tunnel pressure is well~     documented, but why this phenomenon occurs is yet unknown in most patients. There is an~     absolute or relative narrowing of the carpal tunnel, which results in a compression of the~     median nerve.~      The investigators postulate, that a stiffer flexor retinaculum (roof of carpal tunnel) will~     be less compliant. As a consequence of this stiffer retinaculum the pressure in the carpal~     tunnel will rise more quickly in stiff patients resulting in CTS-complaints.~      A relation between connective tissue composition and joint stiffness is proven. This~     relationship possibly extends to a relation between stiffness of the skin, joint stiffness~     and the prevalence of CTS.~   "
189687|NCT01081652|"~     This was an open-label, randomized, comparative, phase III study to evaluate the safety and~     efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.)~     administered once a day in luteal phase support in 200 Chinese female subjects undergoing~     IVF/ET.~   "
189688|NCT01081639|"~     This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate~     the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with~     follitropin beta (Puregon) liquid pen.~   "
189672|NCT01081847|"~     This was a phase I double blind controlled vaccine trial, evaluating safety, tolerability and~     immunogenicity of mixtures of N, R and C LSP derived from the P. vivax CS protein formulated~     in two adjuvants Montanide ISA 720 and Montanide ISA 51.~      The primary objective was to assess in malaria-naïve adults, the safety and reactogenicity of~     these peptides formulated in the two adjuvants~      We recruited 40 healthy men and women volunteers from Cali, Colombia, a city non-endemic for~     malaria. Volunteers were 19--41 years of age and had no history of malaria. During a period~     of three months a total of 100 volunteers were assessed for eligibility criteria in order to~     select a total of 40 volunteers willing to participate in the clinical trial. By consecutive~     allocation, eight participants were allocated to each of the five experimental groups (A--E):~     four groups (A--D) were immunized with the vaccine formulations at two different dose~     concentrations and formulated in two different adjuvants. A control group (E) was injected~     with placebo (saline solution)~   "
189673|NCT01081834|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2~     different doses of canagliflozin administered as monotherapy compared with placebo in~     patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.~   "
189674|NCT01081821|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics~     (how the drug is absorbed in the body, how it is distributed within the body and it is~     removed from the body over time) of single doses of JNJ-39758979 in healthy Japanese~     volunteers and multiple doses of JNJ-39758979 in healthy Japanese and Caucasian volunteers.~   "
189675|NCT01081808|"~     RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with~     antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the~     lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the~     number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated~     autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated~     autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients~     with recurrent, refractory, or metastatic advanced solid tumors.~   "
189676|NCT01081795|"~     The purpose of this study is to determine a recommended dose of topiramate in participants~     with migraine (type of severe headache that occurs periodically and is often associated with~     nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically~     more effective) of the drug to placebo (an inactive substance that is compared with a drug to~     test whether the drug has a real effect in a clinical trial), and to assess if a same~     therapeutic effect can be observed between this study and overseas Caucasian clinical~     studies.~   "
189677|NCT01081782|"~     The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients~     with relapsing-remitting multiple sclerosis over a 26-week treatment period.~   "
189678|NCT01081769|"~     The purpose of this study is to assess the efficacy (how well the drug works; primarily~     through the time to relapse) of long-acting injectable paliperidone palmitate compared to~     treatment as usual with orally administered antipsychotics in monotherapy over 24 months in~     the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.~   "
189679|NCT01081756|"~     This was an open, randomized, comparative study using rhCG (Ovidrel) in the induction of~     final follicle maturation and early luteinization in Chinese female subjects undergoing IVF~     or ET.~   "
189680|NCT01081743|"~     Context: The French Alzheimer plan 2008-2012 includes the implementation of disease~     managers or social workers, from the onset of the disease, for every patient with a~     diagnosis of Alzheimer disease or associated disorder. However, previous trials evaluating~     the efficacy of a systematic intervention for each case from the onset of the disease,~     including non complex cases, have shown little evidence.~      Objective: To evaluate the efficacy of a social worker to prevent behavioural problem for~     patient with a new diagnosis of Alzheimer disease or associated disorder.~      Design and setting: Multicentric cluster randomized control trial. Patients from several~     memory consultations and specialists (neurologist, psychiatrist or geriatrician) in France~     are included.~      Intervention: In addition to usual care, patients in the intervention group have systematic~     home visits from a social worker and regular follow-ups by phone over a one-year period. This~     social worker informs the patient and caregiver, evaluates the needs, gives advices to~     prevent complications and is a link between the patient and the memory consultation or the~     specialist. Patient in the control group have absolutely no intervention and are followed-up~     as usually. In order to not modify the usual care, they have no information on their~     participation in this trial before the one-year evaluation.~      Main outcome measure: NeuroPsychiatric Inventory (NPI) administrated at one year, which~     evaluates frequency, severity and repercussion of several behavioural problems. Secondary~     outcomes included disability, cognition, depression, health, quality of life,~     institutionalization, and resource use.~   "
189681|NCT01081730|"~     The patients included in this observational study will be drawn from a research database~     containing claims and enrollment data for members of a large, geographically diverse US~     health plan. The objective of this study is to estimate the rate of serious infections,~     tuberculosis, malignancies, and other outcomes in psoriasis patients treated with~     ustekinumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic~     non-biological treatments.~   "
189682|NCT01081717|"~     The participants included in this observational study will be drawn from a research database~     containing claims and enrollment data for members of a large, geographically diverse US~     health plan.The objective of this study is to estimate the rate of serious infections,~     tuberculosis, malignancies, and other outcomes in rheumatoid arthritis, psoriatic arthritis,~     and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF)~     biologics, non-anti-TNF biologics, or systemic non-biological treatments.~   "
189683|NCT01081704|"~     A study of the pharmacokinetics of ustekinumab in Chinese male subjects.~   "
189684|NCT01081691|"~     The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a~     single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.~   "
189746|NCT01080859|"~     The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall~     response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus~     ever-olimus-eluting stent (EES) implanted for the treatment of the culprit lesion in acute~     coronary syndrome.~   "
189689|NCT01081626|"~     This is an open-label, prospective, randomized, controlled, multicentric, multinational,~     phase IV study to evaluate the use of Gonal-f in inducing ovulation in female subjects with~     chronic anovulation. It has been observed that conventional high dose set up regimen of~     gonadotropin and human chorionic gonadotropin (hCG) is effective in anovulatory subjects in~     terms of overall pregnancy rates. However, development of multiple follicles leading to~     multiple pregnancy and/or ovarian hyperstimulation syndrome (OHSS) is the major complications~     associated with this high dose set up. Chronic low-dose (CLD) protocols of follicle~     stimulating hormone (FSH), aimed at finding the threshold amount of FSH necessary to promote~     monofolliculogenesis, have been found to be successful in reducing the rate of OHSS almost to~     nil and the rate of multiple pregnancies to a minimum. This post-marketing study will~     investigate tailoring of recombinant follicle stimulating hormone (r-FSH) in a large~     population (N=310) of subjects from a region (North Africa/Middle East) that has not been~     included in previous studies of ovulation induction in subjects with chronic anovulation. The~     study aims to increase current knowledge of the efficacy and safety of Gonal-f, and provide~     fertility physicians with experience in Gonal-f treatment in anovulatory infertility, thereby~     contributing to the development of FSH dosing guidelines for ovulation induction by defining~     the optimal CLD and Low dose (LD) regimens.~   "
189690|NCT01081613|"~     Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer~     patients, particularly in the setting of resistance. A reliable read out system (biomarker)~     for the evaluation of early treatment effect is of great importance in the development of~     this treatment modality, and could contribute to customize this treatment for individual~     patients. So far, no reliable biomarker has been described for HSP90 effect. Visualizing the~     effect of HSP90 on vascular endothelial growth factor (VEGF) secretion in vivo in the~     patient, by whole body 89Zr-bevacizumab uptake, can be of great importance in this respect,~     and may contribute to tailored made cancer treatment. The purpose of the present study is to~     evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89ZR-bevacizumab PET.~   "
189691|NCT01081600|"~     HSP90 inhibition is a potentially new targeted drug modality in the treatment of HER2~     positive, trastuzumab refractory breast cancer. Little is known about the pharmacodynamics of~     HSP90 inhibitors in vivo, but non-invasive PET/CT imaging in a xenograft mouse model could~     visualize and quantify HER2 reduction after AUY922 treatment by 89Zr-trastuzumab PET imaging.~     Two doses of 50 mg/kg AUY922 resulted in a decrease in HER2 expression of approximately 50%,~     quantified 6 days after the last administration of AUY922.~      Visualizing HER2 expression in breast cancer patients before and early following HSP90~     inhibition by means of 89Zr-trastuzumab PET, is likely to provide insight in the early in~     vivo effect of HSP90 inhibition and could potentially support patient tailored therapy.~   "
189692|NCT01081587|"~     This cluster-randomized trial will evaluate the impact of a multifaceted intervention~     (including electronic medical alerts) coordinated by a Nutritional Support Team, on adherence~     to recommended practices for care of starved children, among health personnel of a large~     university hospital. A key component of the study is to assess whether improved adherence to~     guidelines leads to a reduction in rates of complications.~   "
189693|NCT01081574|"~     The conduct of this clinical trial is aimed at determining the most suitable dose regimen for~     children in different age groups, and secondarily to assess the safety and tolerability of~     bilastine in this paediatric population subset.~   "
189694|NCT01081561|"~     This study will determine the efficacy of collagen cross linking for progressive keratoconus~     and ectasia after lasik. It will try and determine which is a more effective treatment:~     collagen cross linking alone or collagen cross linking combined with Intacs, a treatment~     which has already been proven to be effective in decreasing corneal curvature in patients~     with keratoconus.~   "
189695|NCT01081548|"~     The purpose of this study is to compare the efficacy and safety of atorvastatin generic~     product with reference drug.~   "
189696|NCT01081535|"~     The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative~     analgesia in small children undergoing intravesical ureteroneocystostomy.~   "
189697|NCT01081522|"~     As this is a proof-of-concept study, the primary objective is to provide preliminary data on~     the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds~     left to heal by secondary intent.~   "
189698|NCT01081509|"~     The aim of this study is to assess the patient's perception about and willingness to take his~     or her medication and the influencing factors interfering with taking medication.~   "
189699|NCT01081496|"~     To estimate the prevalence of EGFR mutation in a representative sample of patients with newly~     diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).~   "
189700|NCT01081483|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult~     Japanese male subjects.~   "
189701|NCT01081457|"~     Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive~     involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been~     recently developed as a successful treatment for extrapyramidal symptoms. In addition,~     preliminary reports suggest that this therapy might be successful to relieve GI symptoms as~     well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI~     voluntary as well as involuntary motility.~   "
189702|NCT01081444|"~     The aim of this study is to assess if rTMS on healthy hemisphere at one hertz could improve~     patients with post stroke dysphagia.~   "
189703|NCT01081431|"~     The purpose of this study is to determine the safety of lenalidomide and markers for disease~     progression in the treatment of IPSS low- or intermediate-1 risk MDS with isolated del5q.~   "
189704|NCT01081418|"~     The study examined the 12-month effectiveness of continuous therapeutic assertive community~     treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment~     area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with~     quetiapine IR.~   "
189743|NCT01080898|"~     Determination of the sensitivity and specificity of different combinations of imaging~     techniques (spectral domain optical coherence tomography, fundus photography and fluorescein~     angiography) used for the diagnosis of choroidal neovessels complicating age -related macular~     degeneration. This information will help to determine the choice of the most suitable~     combination for the above diagnosis.~   "
189705|NCT01081405|"~     To exploit the curative potential of allografting, the ultimate clinical goal is to separate~     GVL from GVHD. In murine preclinical models, recipients of allogeneic hematopoietic cell~     transplants after a preparative regimen of total lymphoid irradiation (TLI) and antithymocyte~     globulin (ATG) did not develop GVHD. The murine TLI/ATG study was turned into a clinical~     phase I protocol for patients with hematological malignancies, and a reduction of acute GVHD~     to < 3% was observed (Lowsky R et al, N Engl J Med). This suggests that specific immune~     mechanisms control GVHD and preserve GVL. The study will include patients with lympho and~     myeloproliferative diseases. The conditioning regimen will consist of TLI [ten 80 cGy~     fractions on day -11 through day -7 and on day -4 through day -1; the radiation field (four~     fields—two anterior and two posterior) involves all major lymphoid organs including the~     thymus, spleen and lymph nodes] and ATG (five i.v. doses at 1.5 mg/kg/day from day -11~     through day -7). G-CSF mobilised hematopoietic cells, collected on days -1 and 0, from~     HLA-identical siblings or unrelated donors will be infused on day 0. Post-transplant~     immunosuppression will consist of oral cyclosporine (at 6.25 mg/kg/d) from day -3 and~     micophenolate mophetile (at 15 mg/Kg bid) from day +1. The clinical primary objective is to~     reduce the incidence of GVHD to < 5%, with better survival and quality of life.~   "
189706|NCT01081392|"~     The purpose of the study is to measure inflammatory biomarkers in sputum and peripheral blood~     in healthy volunteers after inhalation of single doses of LPS (20 mcg) administered as~     particles of different sizes.~   "
189707|NCT01081379|"~     The purpose of this study is to find a correlation between function of cytomegalovirus~     -specific T cells and the probability for intrauterine transmission.~   "
189708|NCT01081366|"~     All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel~     releasing balloon for coronary arteries in daily clinical practice.~   "
189709|NCT01081353|"~     To determine the bioequivalence of new formula of aspirin relative to the established~     commercial effervescent aspirin when taken orally by healthy adult subjects~   "
189710|NCT01081340|"~     The purpose of this study is to examine whether we can use social networks to spread health~     information and health behaviors that 1) support women in returning to their pre-pregnancy~     weight after delivery; and 2) promote healthy infant feeding practices.~   "
189711|NCT01081327|"~     Patients with atrial fibrillation are often anticoagulated with Warfarin. Warfarin has a~     narrow therapeutic window requiring frequent monitoring. This study aims to investigate the~     incidence of adverse events in the real world for patients receiving Warfarin for lone~     atrial fibrillation.~   "
189712|NCT01081314|"~     Individuals with borderline personality disorder (BPD) are the quintessential multi-problem~     patients, often presenting to treatment with numerous dysfunctional behaviors and comorbid~     diagnoses. Dialectical Behavior Therapy (DBT) is a comprehensive, cognitive-behavioral~     treatment for BPD that has been shown effective in reducing the primary problems it is~     designed to treat; namely, the frequency and severity of self-injurious and suicidal~     behavior, maintenance in treatment, and severe problems in living. However, the DBT treatment~     manual does not currently include a protocol specifying when or how to treat posttraumatic~     stress disorder (PTSD), a comorbid diagnosis that is prevalent in BPD patients and may~     maintain or exacerbate BPD criterion behaviors. Similarly, many of the existing treatment~     outcome studies for PTSD have excluded suicidal, substance abusing, and multiply diagnosed~     patients, thereby making it difficult to determine the generalizability of these approaches~     to individuals with BPD. The research proposed here is focused on the development of a~     protocol based on Prolonged Exposure therapy to treat PTSD in BPD patients that can be~     integrated into standard DBT, as well as the initial evaluation of this protocol's~     feasibility, acceptability, and efficacy. The treatment development and pilot testing process~     will occur in two phases, including measure development and standardization of the treatment~     protocol via clinical pre-testing (Phase 1); and pilot and feasibility testing of the~     intervention via a randomized controlled trial (RCT) comparing standard DBT + PTSD Protocol~     to standard DBT Only (Phase 2). Information gathered during the pilot RCT will be used to~     inform the design and conduct of a subsequent full-scale RCT. This research has the potential~     to significantly expand and improve upon the most empirically supported treatment currently~     available for BPD, while also demonstrating that exposure treatments for PTSD can be~     implemented safely and effectively in a BPD population.~   "
189713|NCT01081301|"~     Family caregivers of terminally ill persons describe hope as inner strength that will help~     them continue caregiving. Our research team has developed and pilot tested a Living with Hope~     Program (LWHP) for caregivers of family members with advanced cancer, with the goal of~     fostering hope and improving quality of life (www.usask.ca/nursing /research/livingwithhope).~     The caregivers involved in our pilot test found the LWHP easy to use and we found some~     evidence to suggest that the program may have increased their hope and improved their quality~     of life. We would like to further develop and test the LWHP by finding out more about how and~     how long it might work. We believe it will improve the quality of life of active and bereaved~     older rural women of persons with advanced cancer and may decrease the number of~     prescriptions and doctor visits over one year. Since rural women caring for persons with~     advanced cancer seem to have the least hope, we want to focus on them first before including~     other caregivers in our research. Two hundred rural women caring for a person with advanced~     cancer will be asked to take part in this study. Their feelings of control, loss and grief,~     quality of life and hope will be measured over a year. The numbers of time they visit their~     physician and how many prescriptions they have over the year will also be collected. This~     study will contribute to the refinement of a Living with Hope Program that may improve~     quality of life and personal health of older rural women caring for their spouse with~     advanced cancer and those who subsequently become bereaved.~   "
189714|NCT01081288|"~     Nationwide cluster-randomised trial of extending the NHS breast screening age range in~     England~   "
189715|NCT01081275|"~     This study will compare two different kinds of physical therapy to improve use of the hands~     in individuals with multiple sclerosis (MS). One treatment will be Constraint-Induced~     Movement therapy (CI therapy), the other will be a set of Complementary and Alternative~     Medicine (CAM) treatments (yoga, relaxation exercises, aquatherapy, massage). The study will~     determine which of the two forms of treatment is more successful for improving hand use.~   "
189726|NCT01081119|"~     We are currently working in 16 middle schools across Los Angeles, Santa Monica and Torrance~     to test out a voluntary after school program called Project CHOICE, which focuses on helping~     students decrease their alcohol and drug use. We are conducting surveys in all schools over~     three years and providing the intervention in 8 schools in the 2008-2009 school year and in~     the other 8 schools in the 2011-2012 school year. This is a program we have provided before~     in middle schools and we found that it was effective in curbing alcohol and drug use among~     students who voluntarily attended and among all students at the intervention school.~   "
189716|NCT01081262|"~     This randomized phase III trial studies carboplatin given together with paclitaxel with or~     without bevacizumab to see how well it works compared with oxaliplatin given together with~     capecitabine with or without bevacizumab as first-line therapy in treating patients with~     newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or~     fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel,~     oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not~     yet known which regimen of combination chemotherapy given together with or without~     bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.~   "
189717|NCT01081249|"~     Subjects—currently in outpatient mental health care--will participate in 2 psychotherapy~     sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped,~     and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive~     benefits on nonverbal behavior in the therapy session, as well as have positive effects on~     subjective anxiety, cortisol and heart rate.~   "
189718|NCT01081236|"~     Patients with liver cirrhosis have an increased risk to develop life-threatening~     complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal~     barrier, changes in numbers and composition of the intestinal microbiota and alterations in~     immune defenses have been suggested to be involved in liver cirrhosis and its complications.~     Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic~     substances from the gastrointestinal tract that may damage the liver, leading to oxidative~     stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is~     considered a key step in the development of spontaneous infections, mainly SBP, in patients~     with liver cirrhosis.~      The investigators hypothesize that patients with decompensated liver cirrhosis have a more~     impaired intestinal epithelial barrier and altered intestinal microbiota than patients with~     compensated liver cirrhosis.~   "
189719|NCT01081223|"~     TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can~     produce immune cells, called 'killer' white blood cells that have the ability to kill large~     numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to~     generate large numbers of those 'killer' white blood cells and to deliver those cells into~     your body so that they can kill your cancer cells.~   "
189720|NCT01081210|"~     Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical~     department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia,~     hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall~     bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic~     tool in these diagnosis, and on early diagnosis is crucial both on behalf of the patients~     well-being, and for hospital logistic reasons.~        1. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool~          in an department of internal medicine.~           Method: All patients admitted (in certain preset periods) to Department of medicine will~          be screened with pocket sized US by expert user. Changes in diagnoses, as well as~          medications as a result of US screening will be the endpoints. US findings will be~          validated against standard echocardiography, or standard US/CT/MRI performed at the~          Radiological department.~        2. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool~          in a department of cardiology.~           Method: All patients admitted (in certain preset periods) to Department of cardiology~          will be screened with pocket sized US for heart disease, pericardial and pleural~          effusion. Examinations by expert users. Specific findings could be myocardial~          dysfunction as heart failure, cardiomyopathies, regional dysfunction due to ischemia,~          valvular dysfunction, atrial enlargement, and pleural/pericardial effusion. Changes in~          diagnoses, as well as medications as a result of US screening will be the endpoints. US~          findings will be validated against standard echocardiography in all.~        3. As in 1), but examination by non-expert users compared to expert users.~   "
189721|NCT01081197|"~     Alcohol abuse is associated with a variety of clinical diseases, but studies on prevalence of~     different somatic diseases among alcohol abusers are lacking. Studies on populations in an~     out-day patients' clinic are also lacking.~      The investigators aim to study somatic health standard in an out-day patients' clinic~     population of alcohol abusers, with regard to prevalence of different kinds of somatic~     diseases, and how the interaction of somatic and psychiatric treatment can influence on~     patients quality of life. Clinical examination including blood samples and echocardiographic~     examinations in all participants, other additional examinations (as x-ray, CT or MRI if~     indicated by clinical findings).~   "
189722|NCT01081184|"~     Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation,~     proliferation, and survival of both neuronal cells and astrocytes. In recent years, several~     studies have provided evidences that the cellular effects of NGF  Nerve Growth Factor ,~     BDNF  Brain-Derived Neurotrophic Factor  and NT-3 are not limited to the nervous system.~     Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data~     concerning the implication of NTs and their receptors in the immune system maturation and in~     the regulation of normal and pathological immune responses are numerous and suggest the~     existence of a specific neuro-immunomodulation through these neuropeptides.~      The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic~     and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously~     pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The~     increased levels of BDNF were correlated to T cell activation. A similar correlation between~     high NGF level and hypergammaglobulinemia was also pointed out.~   "
189723|NCT01081158|"~     Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCH 900518~     in Naive or Treatment-Experienced Subjects Infected With Hepatitis C Virus Genotype 1~     (Protocol No. P04695)~   "
189724|NCT01081145|"~     The primary objective of this study is to evaluate the long-term maintenance of efficacy of~     Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with~     attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short~     term treatment with SPD503.~   "
189725|NCT01081132|"~     To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with~     placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured~     by the ADHD-RS-IV~   "
189728|NCT01081093|"~     Biventricular Pacing has been shown an improvement of symptoms in patients with heart~     failure.~      A temporary pacing is necessary in patients after cardiac procedures. In patients with~     hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac~     output and blood pressure.~      The investigators propose that biventricular pacing in these patients and conditions results~     in an improvement of symptoms instead of single right pacing.~   "
189729|NCT01081080|"~     This protocol will exploit novel state of the art cardiovascular magnetic resonance~     techniques to examine important changes in the heart in children with muscular dystrophy. The~     purpose of this study is to compare cardiac magnetic resonance (CMR) with the collected~     cardiac outcome data obtained in protocol: PITT1109 - Cardiac Outcome Measures in Children~     with Muscular Dystrophy.~   "
189730|NCT01081067|"~     Evaluate the effect of probiotics on stool output in children 1 - 18 months old.~   "
189731|NCT01081054|"~     The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for~     non complicated diverticulitis compared with management in the hospital. The hypothesis is~     that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not~     inferior to the conservative management in hospital in patients with acute not complicated~     sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively~     randomized to conservative antibiotic treatment either to ambulatory or to hospital~     treatment.~   "
189732|NCT01081041|"~     This study will begin with a 30 participant lead-in part: these 30 participants will receive~     cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy~     drugs [cisplatin or carboplatin plus 5-fluorouracil (5-FU)] administered every 3 weeks. After~     18 weeks, participants who benefit from this treatment may continue to receive cetuximab~     once-weekly until progression of the disease, an unacceptable side effect occurs,~     participants withdraw consent, or the study is closed.~      In the second part of this study, 200 participants will be randomized in 2 arms:~        -  100 participants will receive commercial cetuximab manufactured by ImClone (Group A)~        -  100 participants will receive cetuximab manufactured by Boehringer Ingelheim (Group B).~      All these 200 participants will receive other chemotherapy drugs (cisplatin or carboplatin~     plus 5-FU) administered every 3 weeks. After 18 weeks, participants who benefit from this~     treatment may continue to receive cetuximab once-weekly until progression of the disease, an~     unacceptable side effect occurs, participants withdraw consent, or the study is closed.~   "
189733|NCT01081028|"~     The purpose of the Connect® MM Registry is to explore the natural history and real world~     management of patients with newly diagnosed symptomatic multiple myeloma (MM) and provide~     unique insights into the management of MM and the impact of this hematologic disorder on~     patients.~   "
189734|NCT01081015|"~     The purpose of the Connect™ Chronic Lymphocytic Leukemia (CLL) Disease Registry is to explore~     the history and real world management of patients diagnosed with CLL, provide insight into~     the management of CLL, and evaluate the effectiveness of first, second and subsequent~     therapeutic strategies employed in both the community and academic settings.~   "
189735|NCT01081002|"~     It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper~     gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical~     pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol~     sedation. The aim of this study is therefore to quantify the impact of a topical pharyngeal~     anesthesia to the upper gastrointestinal endoscopy in patients sedated with propofol.~      Patients will be randomized to receive a topical pharyngeal spray containing either an~     anesthetic drug (lidocaine 10%) or a placebo. Thereafter the upper endoscopy will be~     conducted in its standard manner.~   "
189736|NCT01080989|"~     The study project can be divided into two parts: (1) health screening for the community and~     (2) clinical diagnosis and treatment for patients at National Referral Hospital (NRH) in~     Solomon islands. The health screening includes a questionnaire, stool parasitic screening and~     blood laboratory tests. A total of 800 subjects will participate in this study. The collected~     samples are venous blood (20 ml/per subject) and stool in order to conduct the related tests~     mentioned above.~      As for the collection of target patients, KMUH will cooperate with NRH to collect two kinds~     of blood samples: the blood samples of confirmed malarial cases and those of cases suspicious~     of Flaviviral, Alpha-viral, Rickettsial, and Leptospiral infections. The expected received~     cases are 600 each year. The venous blood samples (20 ml/per subject) will be used to conduct~     related tests mentioned above. At the same time, the subjects will also have to fill out a~     related questionnaire which includes height, weight, waist line, heath behavior and habit,~     and past history, etc.~   "
189737|NCT01080976|"~     Abstract Diabetes behavior can be influenced by patients exploring diabetes topics that may~     lack scientific credibility. The question this study examines is whether a Google or Health~     on the Net (HON) internet search, presents websites that would incline a more or less likely~     recommendation to patients ? A preliminary trial suggests that referrers recommend websites~     based on rules that may prioritize website source over content. This study will qualitatively~     assess the rules that participants use in deciding which websites are more suitable than~     others.~      Method The investigators will inject a diabetes related search term into a HON and a Google~     search engine. The top 5 mutually exclusive websites from each search engine will be~     presented to 5 people from three groups stratified across endocrinologists, informaticians~     and PCPs. Participants will rank the websites and then identify the rules that they applied~     to reach their decision.~   "
189738|NCT01080963|"~     The purpose of this study is to show that the incidence of sternal wound infections at day 30~     after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard~     antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.~   "
189739|NCT01080950|"~     Zinc and vitamin d deficiency are associated with a state of inflammation/atherosclerosis.~      There are studies demonstrating an association between vitamin d deficiency and respiratory~     illnesses.~      Both zinc and vitamin d are associated with oxidative stress and inflammation.~   "
189740|NCT01080937|"~     During the last decade, progress has been made in the management of heart failure. However,~     the changing characteristics of patients and practices in the real world and their impact~     on the prognosis of patients admitted for acute heart failure remain poorly studied.~      2000 consecutive patients recruited in a single day in hospitals volunteered to participate~     in the cohort during a day dedicated.~   "
189749|NCT01080820|"~     The purpose of this study is to evaluate the safety and tolerability of CMX157 and the amount~     of CMX157 that reaches the blood stream, the manner in which the body processes CMX157 and~     the time that it takes to eliminate CMX157 following one oral dose when given to healthy~     volunteers.~   "
189750|NCT01080807|"~     The primary objective of the study is to determine whether armodafinil treatment is more~     effective than placebo treatment in patients with excessive sleepiness associated with shift~     work disorder (SWD) by measuring improved clinical condition late in the shift, including the~     commute home.~   "
189751|NCT01080794|"~     The purpose of this study is to determine if repetitive transcranial magnetic stimulation~     (rTMS), a method of noninvasive brain stimulation) is effective in the treatment of the motor~     (movement) and mood symptoms due to Parkinson's disease (PD).~   "
189752|NCT01080781|"~     -  Background : Ephrin-B1 is part of the large Eph/Ephrin system which is involved in~          cell-cell comunication. The role of Ephrin-B1 has scarcely been studied in adulthood.~          Our team has shown that this protein is expressed in normal heart in mice and humans. In~          mice with deletion of the gene encoding Ephrin-B1, we have shown progressive development~          of dilated cardiomyopathy characterized by dramatic disorganization of cardiac tissue~          architecture and decreased heart rate variability.~        -  Purpose: Ephrin-B1 protein was recently identified in human heart but its putative role~          remains unknown. In knockout mice, deletion of efn gene is associated with abnormalities~          in cardiac architecture linked to defects in cell-cell tight junctions. From a~          functional point of view, mice develop a dilated cardiomyopathy and exhibit decreased~          heart rate variability in the frequency domain. The purpose of this study is to assess~          if Ephrin-B1 expression is regulated in human heart and if expression level correlates~          with heart rate variability.~        -  Abstract: Thirty patients suffering from cardiac disease needing surgery will be~          included and separated in two groups according to pressure levels in right auricle /and~          or pulmonary artery. Ephrin-B1 expression will be assessed in right appendages at both~          the transcriptional (quantitative PCR) and protein (Western blot) levels. Furthermore,~          the putative relationship between Ephrin-B1 expression and heart rate variability (24~          hours ECG recordings) will be investigated.~   "
189753|NCT01080768|"~     The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can~     attenuate ankle edema formation in hypertensive patients.~   "
189754|NCT01080755|"~     This is a multicentric, longitudinal, observational study with the prospective follow-up of~     Adult subjects with Growth Hormone Deficiency (AGHD) being treated with Saizen, every six~     months in the first year and then annually. At the request of health authorities, the sponsor~     has arranged for the follow-up of prescriptions and treated subjects within the scope of this~     indication.~   "
189755|NCT01080742|"~     This is an observational, prospective, non-interventional, non-randomised, open label~     multicentric study planned to be conducted in 1000 subjects with mild to moderate primary~     hypertension in approximately 20 centres in Thailand. The purpose of this study is to examine~     the beneficial effects of combination of bisoprolol with hydrochlorothiazide available as~     Lodoz in treatment of Thai subjects with mild to moderate hypertension. The outcome of the~     study would also provide information on the optimal daily dosage schedule as well as~     adherence of Lodoz.~   "
189756|NCT01080729|"~     This is a prospective, observational and multicentric study to compare the Gonal-f FbM~     (filled by mass) dose prescribed by the doctor with the Gonal-f FbM dose determined by the~     CONSORT (Consistency in r-FSH Starting doses for individualized treatment) calculator.~   "
189757|NCT01080716|"~     This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the~     WRSS1 candidate vaccine in healthy Thai adult volunteers. This study is designed as 2 parts.~        -  Part 1 is a blinded, placebo-controlled inpatient trial in a total of 20 volunteers (14~          vaccinees and 6 controls) to determine the safety and immunogenicity. Volunteers will be~          vaccinated with a single oral dose of 104 colony forming unit (cfu) of WRSS1 or placebo~          given with bicarbonate buffer.~        -  Part 2 will be started approximately 60 days after WRSS1 vaccination. This part is an~          inpatient phase II efficacy trial involving a challenge with the S.sonnei 53G of 10~          vaccinees from the first part and 10 naïve controls.~   "
189758|NCT01080703|"~     The purpose of this study is to determine if a lower extremity strengthening program as part~     of pulmonary rehabilitation will improve quadriceps muscle strength, endurance and functional~     status as well as overall quality of life.~      Hypothesis:~        1. Lower extremity resistance training as part of a pulmonary rehabilitation program will~          improve quadriceps strength, endurance and functional capacity.~        2. Lower extremity resistance training as part of a pulmonary rehabilitation program will~          improve quality of life in patients awaiting lung transplant.~   "
189759|NCT01080690|"~     Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm~     combining abdominal sonography, gastroscopy, endosonography in patients with acute right side~     abdominal pain.~      Patients with acute right side abdominal pain will be randomized in one of two groups. In~     each group all examinations (sonography, gastroscopy, endosonography) will be performed. The~     study group only defines the order of the examinations. Abdominal sonography will always be~     performed before endoscopic procedures. In group 1, gastroscopy is first followed by~     endosonography. In group 2 endosonography is first followed by gastroscopy.~      Two physicians will review all results of all examinations, patient charts as well as a~     follow up visit and establish a clinical diagnosis.~      Yield of the clinical diagnosis by EUS results alone will be compared to the yield by~     combined results of sonography, EGD and EUS.~   "
189760|NCT01080677|"~     This is a research study to assess the safety of caffeine/propranolol at different dose~     levels. We want to find out what effects, good and/or bad, it has on patients and their~     migraines.~   "
189761|NCT01080664|"~     EMD Serono decided to terminate enrollment based on a review of the available clinical data~     and low probability of completing the trial based on the observed recruitment rate. Subjects~     already enrolled in the study continued participation in the study, consistent with the~     protocol, to study completion.~   "
189762|NCT01080651|"~     To evaluate the drug-drug interaction between rifampicin and voriconazole according to~     CYP2C19 genotype quantitatively following a single oral administration of 200 mg voriconazole~   "
189764|NCT01080625|"~     Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver~     transplantation which is characterized by an acute drop in blood pressure immediately after~     the prefusion is restored to the transplanted liver. We hypothesized that PRS would be~     prevented when phenylephrine or epinephrine is administered immediately prior to reperfusion~     in liver transplantation.~   "
189765|NCT01080612|"~     The purpose of this study is to (1) evaluate the effect of caloric intake on the~     pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative~     to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the~     safety and tolerability of a single dose of a 330 mg pregabalin controlled release~     formulation administered following various sized caloric meals and the 300 mg pregabalin~     immediate release capsule administered fasted.~   "
189766|NCT01080599|"~     The purpose of this study is to compare the success rate of two approaches for obturator~     nerve block in TURB (conventional pubic approach [Labat technique] and inguinal approach.~   "
189767|NCT01080586|"~     To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules~     Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference~     Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis~     Pharmaceuticals Corporation, New Jersey, in 78 healthy adult male subjects under fed~     condition.~   "
189768|NCT01080573|"~     This 1-arm, open-label, multicentric, observational study aims to collect subject centric~     information in line with routine care. Subjects' expectations of therapy, side effect~     management and lifestyle may influence adherence to therapy. This survey aims to determine~     whether such factors and/or others affect the successful initiation and maintenance of Rebif~     therapy.~      The data collected during this study will include information on the subject's treatment~     including expectations, experience, training and support. The results of the study will be~     used to understand the impact on subjects' compliance and tailor training and support~     services to subject's need. It will also be made available to other healthcare organisations~     involved in the subjects treatment.~   "
189769|NCT01080560|"~     To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules~     Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference~     Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis~     Pharmaceuticals Corporation, New Jersey, in 36 healthy adult male subjects under fasting~     condition.~   "
189770|NCT01080547|"~     A new notionFast Track Multi-Discipline Treatment for colorectal cancer is thought with~     several benefits such as shorter hospitalization stay and less costs. This randomized study~     aims to compare the differences between conventional and Fast Track Multi-Discipline~     Treatment for colorectal cancer in hospitalization day, complications, costs and quality of~     life.~   "
189771|NCT01080534|"~     The objective of the study is to demonstrate bioequivalence between Test Product (A):~     Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding~     Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma,~     Inc., USA in 36 normal, healthy, adult, male subjects under fed condition.~   "
189772|NCT01080521|"~     This clinical trial is studying changes in brain function in patients with stage I, stage II,~     stage III, or stage IV ovarian, primary peritoneal, or fallopian tube cancer who are~     receiving chemotherapy. Learning about the effects of chemotherapy on brain function may help~     doctors plan cancer treatments.~   "
189773|NCT01080508|"~     The primary objective of the study is to describe the pressure patterns during esophageal and~     tracheal ventilation and to validate the diagnostic algorithm.~   "
189774|NCT01080495|"~     Assessment of left ventricular function is an essential determinant of overall hemodynamics~     and heart function and therefore of central interest in intra-operative transesophageal~     echocardiography.~      Currently, the most frequently used methods for quantification of left ventricular function~     are fractional shortening (FS) and fractional area change (FAC).~      Radial strain is a new parameter to asses left ventricular function. The investigators want~     to assess left ventricular function with radial strain, fractional shortening (FS) and~     fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim~     of this study is to show that radial strain is as reliable as FS and FAC in left ventricular~     function assessment and more robust to changes in preload and afterload conditions.~   "
189775|NCT01080482|"~     The objective of the study is to demonstrate bioequivalence between Test Product (A):~     Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding~     Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma,~     Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.~   "
189776|NCT01080469|"~     The objective of the study is to demonstrate bioequivalence between Test Product (A):~     Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding~     Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma,~     Inc., USA in 36 normal, healthy, adult, male subjects under fed condition.~   "
189777|NCT01080456|"~     The objective of the study is to demonstrate bioequivalence between Test Product (A):~     Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding~     Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma,~     Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.~   "
189778|NCT01080443|"~     The objective of the study is to compare the bioavailability and characterise the~     pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India~     and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA~     in normal, healthy, adult human subjects under fasting conditions, and to assess the~     bioequivalence.~   "
189790|NCT01080287|"~     This is a study to compare subject response and symptoms resulting from administration of~     three clinical assessments.~      * The 3 assessments are~        1. passive upright tilt table testing,~        2. quantitative sudomotor axon reflex testing (QSART)and~        3. punch biopsy.~      The comparison of results will be from two subject groups:~        -  Group A, the migraine suffering patient with or without aura~        -  Group B, the migraine suffering patient with or without aura who has diagnosed~          orthostatic intolerance (i.e.,feeling dizzy or faint when making a body position~          change).~   "
189779|NCT01080430|"~     Rotational maneuver is a vestibular rehabilitation method, performed in a supervised manner.~     Using a rotating chair, subjects are rotated towards the opposite direction of dominant side~     in order to inhibit this side and simultaneously, stimulate the subordinate side. We propose~     that the rehabilitative effect is the result of a decrease in the vestibular imbalance,~     mainly due to a decrease in the response of the dominant vestibular side. Previously, we have~     shown the short-term effects of this maneuver on patients with recent onset vestibular~     imbalance. In the present study, we investigated the long-term effects of the rotational~     maneuver in patients with a history of peripheral vestibular vertigo for at least one year,~     originally confirmed by clinical tests. Our results show a significant improvement which~     lasted for >4 weeks after the end of rehabilitation (i.e., the last time tested). Moreover,~     there seems to be a relationship between the decrease in DP values and a decrease in~     subjective symptoms. We propose that this maneuver can be used as an effective method for~     both short- and long-term rehabilitation.~   "
189780|NCT01080417|"~     The objective of the study is to compare the bioavailability and characterise the~     pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India~     and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA~     in normal, healthy, adult human subjects under fed conditions, and to assess the~     bioequivalence.~   "
189781|NCT01080404|"~     Obesity is an increasing problem worldwide. Over 20% of people in western societies are obese~     (BMI >30kg/m2) and 1-2 % are morbidly obese (BMI >40 kg/m2). According to the recent study~     6.6% of Finns are severely obese (BMI > 35kg/m2) and 2.0% are morbidly obese (BMI>40kg/m2).~     Because conventional treatments often fail to induce sustained weight loss obesity surgery~     has increased rapidly in many countries. Currently, > 300000 procedures are performed in the~     US each year. Thus in many European countries, including Finland, the need for obesity~     surgery is rapidly increasing.~      The most important risk factor also for obstructive sleep apnea (OSA) is obesity, and thus~     effective treatment of obesity is the first-line treatment of OSA. However, Reliable~     information of the prevalence of OSA in morbidly obese patients is still lacking. The current~     knowledge is based on small studies, which have demonstrated that the prevalence of OSA may~     be higher than believed, even 70-80% in morbidly obese patients. There is a definite need for~     large, well-designed, prospective clinical studies to evaluate the effects of weight~     reduction in OSA and other co-morbidities related to obesity. Ever increasing research data~     showing a strong link between obesity and OSA and their co-existence as a major risk factor~     in the development of cardiovascular diseases should provoke concepts to search better~     clinical guidelines of diagnostics and treatments in a risk group, such as morbidly obese~     patients.~   "
189782|NCT01080391|"~     To compare progression-free survival in subjects with relapsed multiple myeloma who are~     receiving CRd vs subjects receiving Rd in a randomized multicenter setting.~   "
189783|NCT01080378|"~     The overall objective of this study is to investigate in depth the impact of birth weight on~     the nature of metabolic physiology, body composition and epigenetic differences of the~     different phenotypes of overweight and obese individuals who are otherwise overtly healthy.~     We also aim to determine the efficacy of a weight loss intervention on the above mentioned~     metabolic parameters in these individuals.~   "
189784|NCT01080365|"~     Study comparing 2 formulations of bosutinib in healthy subjects.~   "
189785|NCT01080352|"~     Can high dose, intravenous Vitamin C prolong life for patients with metastatic prostate~     cancer?~      Prostate cancer is the most common cancer (excluding skin cancer) in men in Denmark and the~     Unites States. When metastatic disease is present cure is no longer possible. The main~     treatment at this stage is castration, either surgical or medical, ending the patients~     testosterone production and causing a temporary regression in disease activity.~      Eventually, the cancer will progress, usually within 2 years from the castration, with a more~     aggressive course and a survival of 2-3 years.~      The current treatment option for the patients, who have undergone castration and have disease~     progression, is chemotherapy with only limited gains in quality of life and survival.~      This clinical study is a phase 2 study to evaluate the effects of high dose intravenous~     vitamin c in subjects with early castration resistant prostate cancer.~      Primary endpoint:~        -  Prostate specific antigen (PSA) changes after 12 to 20 weekly vitamin c infusions~      Secondary endpoints:~        -  Bone metastases changes after 12 to 20 weekly vitamin c infusions~        -  Changes in bone specific alkaline phosphates, oxidative DNA-damage, PINP, NTX after 12~          to 20 weekly vitamin c infusions~        -  RNA-expression changes in prostatic tumor tissue after 12 to 20 weekly vitamin c~          infusions~        -  RNA-expression changes in lymphocytes after 12 to 20 weekly vitamin c infusions~      Tertiary endpoints:~        -  Pharmacokinetics of vitamin c in the elderly cancer patients~      Methods and material:~        -  80 subjects are included (efficacy evaluation when 20 subjects have been evaluated for~          extension arm)~        -  Each subject receives a weekly infusion of 60 grams vitamin c (in the form of ascorbate)~          for 12 to 20 weeks~   "
189786|NCT01080339|"~     Substudy examining cardiovascular and metabolic risk factor change in children at high risk~     for future atherosclerosis who are enrolled in a pilot intervention using novel gaming and~     exercise activities to increase physical activity.~   "
189787|NCT01080326|"~     This study is being done to see if a new approach to repair perforated ulcers in the stomach~     (holes in the stomach) or the first part of the intestine is possible. Traditionally, either~     open operations (large single incision) or laparoscopic operations (multiple small~     camera-guided incisions) have been used to repair perforated ulcers. Over the last ten years,~     some surgeons have used endoscopic equipment to assist them with performing the procedure. It~     is unknown if perforated ulcer repair can be done using an endoscope as the main instrument~     (a flexible tube with a video camera inserted into the stomach through your esophagus) to~     patch or plug the perforation. We will patch the perforation using a standard method which~     uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our~     view. This study is intended to be a feasibility study to demonstrate the endoscopic~     technique can be safely performed~      Hypothesis: The primary outcome is successful completion of the procedure.~   "
189788|NCT01080313|"~     The primary objective of this study is to describe, in detail, patterns of care for head and~     neck carcinoma patient~   "
189789|NCT01080300|"~     Depomed's Gabapentin Extended Release is an investigational, extended release formulation of~     Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in~     postmenopausal women~   "
189791|NCT01080274|"~     Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality.~     Low zinc levels are associated with an increased atherosclerotic burden. Therefore we~     hypothesized that patients with pathological stress test would have low levels of Vitamin D~     and zinc compared to patients with a normal stress test.~   "
189792|NCT01080261|"~     A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60~     patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary~     artery ≥2.25 mm to <2.50 mm in diameter (by visual estimate). Approximately thirty patients~     will be randomly assigned to the angiographic subset to also undergo angiographic assessment~     after the 12-month clinical follow-up.~   "
189793|NCT01080248|"~     To determine the response rate and survival of gemcitabine and pazopanib in patients with~     metastatic pancreatic cancer.~   "
189794|NCT01080235|"~     This is a multi-center exploratory study (each site got local IRB approval) of the impact of~     an educational toolkit combined with a practice-performance self-evaluation instrument (ABIM~     Care of the Vulnerable Elderly Practice Improvement Module) on trainee knowledge, skills, and~     attitudes about practice-based learning and improvement and systems-based practice in the~     care of elderly patients.~   "
189795|NCT01080222|"~     The purpose of this study is to assess the safety and efficacy of combination treatment with~     VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or~     ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C~     virus (HCV) genotype 1 and will not have previously received treatment for their HCV~     infection.~      This study will include an Investigational Phase and Extension Phase. These phases will~     contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the~     Investigational Phase of this study. Subjects who fail treatment during the Investigational~     Phase will have the option to enter the Extension Phase at which point they will be eligible~     to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks.~      Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from~     patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment~     arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based~     combination therapy. The components of the treatment regimens of these arms will be selected~     based on clinical data that emerges from the four initially-studied regimens. If enacted, up~     to 25 patients are expected to enroll in each additional treatment arm.~      If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will~     have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the~     eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.~   "
189796|NCT01080209|"~     This study will evaluate the biodegradation of the brimonidine tartrate posterior segment~     drug delivery system.~   "
189797|NCT01080196|"~     This clinical trial will compare the effects of a high intensity Resistance Exercise via~     Negative Work (RENEW) vs. Traditional resistance exercise (TRAD) as part of a mult-component~     exercise and fall-reduction program on muscle conditioning; falling risks; as well as the~     fall incidence in older adults who have fallen. We anticipate that muscle conditioning will~     mediate the effect of RENEW on falling risks and fall incidence.~   "
189798|NCT01080183|"~     The team's ultimate goal is to improve health care quality and effectiveness and support~     patient-centered care. In this project, we, the investigators, will test whether providing~     patients with guideline based-recommendations regarding tobacco use, physical activity and~     mental and physical health-related quality of life (patient reported measures: PRMs) using~     health information technology increases doctor-patient discussions regarding these topics and~     results in improvements in PRMs. We will randomize physicians in a single general internal~     medicine practice. Patients seeing intervention physicians will receive guideline-based~     recommendations regarding PRMs, those seeing control physicians will not. We will compare~     differences in doctor-patient discussions regarding PRMs between the intervention and control~     groups. The successful completion of this project will provide evidence the effectiveness of~     involving patients in their care through the use guideline-based feedback.~   "
189799|NCT01080170|"~     This study explores how aromatase inhibitor therapy affects risk factors for heart disease in~     postmenopausal women with breast cancer.~   "
189800|NCT01080157|"~     The purpose of this research study is to test the safety and effectiveness of the SCOUT DS in~     measuring the concentration of substances (advanced glycation endproducts) in the skin. These~     substances have been found to be in higher concentrations in people with diabetes and high~     blood sugar. The SCOUT DS is being developed to help doctors measure these substances in skin~     and possibly help doctors diagnose diabetes.~   "
189801|NCT01080144|"~     All patients eligible for TIPS (Transjugular intrahepatic portosystemic shunt) procedure will~     be considered for inclusion. After written inform consent, psychometric tests in order to~     calculate the psychometric hepatic encephalopathy (PHES) score, the gold standard for the~     diagnosis of minimal encephalopathy and critical flicker frequency (CFF) will be performed~     before the TIPS procedure. After TIPS, patients will be followed during one year and the~     psychometric test and CFF will be performed every 3 months.~      30 patients will be included.~      The main endpoint is the success rate of CFF. The secondary end points are~        -  Correlation between CFF and PHES score~        -  Performance of CFF and PHES score to predict the occurrence of overt encephalopathy~          after TIPS procedure~        -  A sample collection during TIPS procedure is also performed for validation of biomarkers~   "
189802|NCT01080131|"~     The purpose of this study was to demonstrate that canakinumab given upon acute gout flares~     relieves the signs and symptoms and prevents recurrence of gout flares in patients with~     frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or~     colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab~     was compared to the corticosteroid triamcinolone acetonide.~      The purpose of the first 12 week extension study was to collect additional safety,~     tolerability and efficacy data in patients who have completed the core study CACZ885H2357.~      The purpose of the second one year open-label extension study was to confirm the long-term~     safety and tolerability of canakinumab in patients who had completed the first extension~     study.~   "
189803|NCT01080118|"~     The use of the video laryngoscope to teach laryngoscopy will improve the performance of~     tracheal intubation done by novices because it will allow a shared view of the airway leading~     to a better feedback from the trainer to the trainee.~   "
189804|NCT01080105|"~     This study will develop and evaluate the effectiveness of a technology-assisted behavioral~     intervention, consisting of Internet-based cognitive behavioral therapy combined with~     telephone and email support, in preventing depressive symptoms and improving treatment~     adherence in individuals at risk of major depressive disorder.~   "
189805|NCT01080092|"~     Craving is one of the most prominent reasons for relapse after smoking cessation. Mainly~     pharmacological aids (NRT, bupropion, varenicline) try to counter this condition. This~     project aims to evaluate the effect of stress-management and a short breathing technique,~     reinforced by means of visualisation , on the experience of craving in smokers who are~     prepared to stay abstinent for at least 3 hours before the start of the intervention. It is~     expected that this strategy can provide supplementary gains in craving control.~   "
189806|NCT01080079|"~     The purpose of this study is to determine if the iontophoretic application of terbinafine gel~     is safe and effective for teh treatment of distal subungual onychomycosis~   "
189807|NCT01080066|"~     This is a prospective, observational, non-interventional, multicenter, post-marketing~     surveillance study to mainly collect safety information from subjects with locally advanced~     and recurrent/metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) treated with~     cetuximab based on the locally approved label.~   "
189808|NCT01080053|"~     This is an observational, prospective, non-interventional, non-controlled study planned to be~     conducted in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS).~      The purpose of this observational study is to determine the correlation between the degree of~     disability and sexual dysfunction; and between the sexual dysfunction and the quality of life~     (QoL) of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina.~   "
189809|NCT01080040|"~     This study is observational, non-controlled, multicentric and prospective, without~     experimental intervention or control. As part of the usual management of the subjects, scales~     will be used for the assessment of the spasticity and the quality of life (QoL).~      The purpose of this observational study is to assess the incidence of spasticity in a group~     of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it~     affects the QoL of these subjects.~   "
189810|NCT01080027|"~     The rationale of this study is to assess the safety profile, efficacy and adherence to Rebif®~     New Formulation in real life settings with a multinational approach, as well as the impact of~     this improved formulation (with regards to adverse events [AEs]) to subjects' adherence.~   "
189811|NCT01080014|"~     This observational study is being conducted to evaluate the usefulness of the MSFC and its~     relationship with EDSS scores in subjects with MS in Argentina.~   "
189812|NCT01080001|"~     This is an observational, non-controlled, multicentric, prospective study planned to be~     conducted in 66 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina.~     Fatigue is recognized as one of the most frequent symptoms of MS with a high incidence in MS~     subjects. The link between fatigue and the degree of disability and other manifestations of~     the disease, such as depression has not been yet clearly understood. Hence, this study aims~     to understand the way in which fatigue impairs the quality of life (QoL) of MS subjects. This~     epidemiologic study can contribute to a better understanding of the way in which fatigue~     correlates with depression and the intensity with which both situations impact on the QoL of~     MS subjects.~   "
189813|NCT01079988|"~     This is a pilot investigational study of the appropriate therapeutic regimens to treat~     subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon~     discontinuation of efalizumab therapy and of the biological mechanisms involved in~     inflammatory disease recurrence and control.~   "
189814|NCT01079975|"~     This is an observational, non controlled, multicentric, prospective study planned to be~     conducted in 350 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina~     to identify the predictive factors leading to depression. The incidence of depression~     symptoms and its influence in the evolution of the disease are unknown in the Argentinean~     population. Early diagnosis of depression symptoms allows the specific treatment of them and~     can also delay the rich apparition of the disease. This study intends to quantify the~     incidence of these symptoms and also aims to evaluate which are the predictive factors of the~     apparition of the depression.~   "
189815|NCT01079962|"~     Antihypertensive drugs aim to reduce blood pressure (BP) either through decrease of the total~     peripheral resistance through vasodilatation at the level of arterioles (microcirculation) or~     by decreasing the cardiac output through reduction of the stroke volume or heart rate or~     both. On the other hand, all antihypertensive drugs might potentially decrease arterial~     stiffness passively with the reduction of the distending pressure or with the~     resynchronization of the reflected pressure wave. With theses potential mechanisms, it is~     also expected that these drugs might exert a favorable effect on pulse pressure amplification~     between central and peripheral arteries.~      However, there is solid evidence that the widely applied antihypertensive drugs have~     differential effect on brachial and central BP. Several reports in the past have confirmed~     the potential hypothesis that beta blockers decrease central BP less than the observed~     reduction at the level of the brachial artery. It has been hypothesized that deceleration of~     heart rate and the re synchronizing the reflected pressure wave earlier in the systolic phase~     seems to be the leading cause of non-favorable effect of beta blockers on central BP, these~     effects might be partially counterbalanced in beta blockers with high beta-1 selectivity~     resulting in less peripheral vasoconstriction properties.~   "
189829|NCT01079780|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab~     may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not~     yet know whether giving cetuximab and irinotecan hydrochloride together is more effective~     with or without ramucirumab in treating colorectal cancer.~      PURPOSE: This randomized phase II trial is studying the side effects and how well giving~     cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients~     with advanced colorectal cancer with progressive disease after treatment with~     bevacizumab-containing chemotherapy.~   "
189816|NCT01079949|"~     Ovarian reserve is related to chronological age; 35 years of age is the accepted threshold~     for significant decline in assisted reproductive technologies (ART) success with scarce~     follicular recruitment and poor oocyte retrieval. New therapeutic schemes are sought to~     improve follicular response in ovarian ageing because of the increasing number of infertile~     women aged older than 35 years who are trying to get pregnant. The advent of gonadotropin~     releasing hormone analogue antagonist (GnRHant) offers new perspectives to address the issues~     related to advanced reproductive age since it prevents premature luteinizing hormone (LH)~     surges while not causing suppression in the early follicular phase. Gonadotropin releasing~     hormone analogue antagonists are administered in the latter stage of the ovarian stimulation~     to prevent LH surge by competitive blockade of gonadotropin releasing hormone (GnRH)~     receptors, thus producing a marked decrease in LH levels just when the interplay between~     follicle stimulating hormone (FSH) and LH becomes important to complete follicular~     development and oocyte competence. Some studies in the past have shown the potential of~     recombinant human LH (r-hLH) supplementation in women of advanced reproductive age to improve~     oocyte quality, but these studies are of small size and did not provide data on the~     physiological mechanism behind the benefit obtained.~      This randomized, comparative, parallel controlled Phase II study will be conducted in~     infertile female subjects aged 35-42 years undergoing in-vitro fertilization (IVF)/intra~     cytoplasmic sperm injection (ICSI), to investigate whether the addition of r-hLH (when the~     lead follicle is greater than [>] 14 millimeter [mm] in size), to the standard protocol with~     recombinant human FSH (r-hFSH) under GnRHant, improves the number and quality of oocytes~     retrieved, implantation rate, and pregnancy rate, while assessing the hormonal milieu in the~     ovarian follicular fluid. Comparison will be performed against ovarian stimulation without~     addition of r-hLH, that is (i.e.) with r-hFSH under GnRHant alone.~   "
189817|NCT01079936|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Revlimid (lenalidomide) and high-dose Alkeran (melphalan) that can be given to~     patients with multiple myeloma who will receive an autologous stem cell transplantation. The~     safety of this combination therapy will also be studied.~   "
189818|NCT01079923|"~     Research has shown that Vitamin D is important in preventing rickets in children,~     osteomalacia in adults, certain cancers, cardiovascular disease, Type 2 Diabetes, and~     metabolic syndrome. Data suggests that Vitamin D deficiency is common throughout the world.~     With increasing medical conditions being linked to Vitamin D deficiency, it is suggested that~     establishing early normal Vitamin D levels is important to long term health.~      There are low quantities of maternal Vitamin D that transfer from blood into breast milk.~     This places nursing infants at risk of developing low Vitamin D levels, and the American~     Academy of Pediatrics recommends they receive 400 international units (IU) of Vitamin D~     daily. If nursing mothers were supplemented with oral Vitamin D, this may produce adequate~     total Vitamin D in the breast milk for the growing infant to consume. By taking this~     potential therapeutic approach, this would prevent the burden of administering an oral~     Vitamin D liquid supplement to an infant.~      Recent laboratory technology now allows measurement of total Vitamin D (parent Vitamin D2~     plus parent Vitamin D3). The main objective of this pilot study is to compare total Vitamin D~     levels resulting from daily Vitamin D supplementation of 5,000 international units of~     cholecalciferol (Vitamin D3) orally for 28 days vs. 150,000 international units of~     cholecalciferol orally once in healthy, non-pregnant, non-lactating female subjects aged 18 �~     40. The research results will be used to help identify an optimal dosing regimen to~     administer to lactating mothers to hopefully deliver adequate total Vitamin D in nursing~     infants. This separate study will be conducted at a later date under a subsequent protocol.~      Previous research has demonstrated that Vitamin D3 levels become undetectable within 14 days~     after adult subjects received 100,000 international units of cholecalciferol. The~     investigators' central hypothesis is that daily dosing of 5,000 international units of~     cholecalciferol orally will maintain detectable total Vitamin D levels in serum after~     fourteen days, compared to high-dose 150,000 international units of oral cholecalciferol~     once.~      It is anticipated the aims of this pilot study will yield the following results. First, we,~     the investigators, hope to determine the resulting Vitamin D blood levels and calculate an~     appropriate dosing strategy for future research. Next we plan to measure the resulting~     25,hydroxyvitamin D levels that correspond with these dosing regimens, since~     25,hydroxyvitamin D is the major indicator of Vitamin D status in humans. Lastly, we will~     measure blood calcium and phosphorus levels to assure these doses of Vitamin D are tolerated~     by healthy female subjects.~   "
189819|NCT01079910|"~     The objective of this study is to evaluate the effect of an experimental toothpaste on~     maintaining gingival health over a 24 week period measured through modified gingival index,~     bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will~     undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and~     weekly professional tooth cleaning to bring the subjects to their optimum gingival health~     prior to commencing study treatment.~   "
189820|NCT01079897|"~     This study evaluates the efficacy of the topical used ectoine-formulation EHK02-01 compared~     to Atopiclair. Patients are examined at visit 2 (baseline visit). The patient topically~     applies EHK02-01 or Zarzenda® twice daily on two symmetric lesional areas over 28 days.~     Response to therapy is recorded at each visit.~   "
189821|NCT01079884|"~     The implications of sleep as it relates to the physiology and pathogenesis of a number of~     diseases has until recently been ignored. With the evolution of sleep laboratories, there is~     an emerging recognition of the relationship between sleep and various gastrointestinal~     diseases- in particular gastroesophageal reflux disease (GERD).( 1-5) It seems intuitive that~     waking/daytime activities or events may affect sleep and that any consequent sleep~     dysfunction may reciprocally further affect daytime function~   "
189822|NCT01079871|"~     The primary objective of this study is to assess the overall Sjogren's Syndrome subject's~     preference for a particular product. Dry eye symptom relief will also be evaluated based on~     clinical evaluation and a set of subject questionnaires.~   "
189823|NCT01079858|"~     The primary objective of this study is to assess the overall Meibomian Gland Dysfunction~     Subject's preference for a particular product. Dry eye symptom relief will also be evaluated~     based on clinical evaluation and a set of subject questionnaires.~   "
189824|NCT01079845|"~     Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents~     in susceptible girls around the time of menarche. Females with PCOS have high levels of~     androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and~     menstrual disturbances were once considered the primary concerns, emerging data indicate that~     many adolescents and young adults with PCOS are insulin resistant and at increased risk for~     metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body~     fat amplifies the severity of the syndrome.~      Dietary intervention is considered an important component of treatment for PCOS. However, a~     consensus statement regarding optimal nutrient composition for treating adolescents and young~     adults with PCOS has not been published because data are lacking to provide a foundation for~     such a statement. Recognizing increased risk for diabetes in patients with PCOS, many~     practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP)~     for weight loss and control of symptoms.~      Objective and Hypothesis. The purpose of this research study is to compare different diets~     for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood~     levels of glucose and insulin - will be more beneficial than a low-fat diet in obese~     adolescents and young adults with PCOS.~      Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years)~     will be assigned to receive one of two dietary treatments, with the goal of retaining 40~     participants. Group assignment will be at random. One of the treatments will be a~     low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP~     diet). Participants in both groups will receive individual nutrition education and dietary~     counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops~     with a chef. The purpose of the cooking workshops will be to enhance compliance with diet~     prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a~     conventional clinic setting.~      The primary outcome will be bioavailable testosterone (form of testosterone that causes~     symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high~     androgen levels (total testosterone, free testosterone, sex hormone binding globulin,~     dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair,~     acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin~     measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive~     protein levels and blood pressure), body fat percentage and distribution (measured using~     state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual~     cyclicity, and health-related quality of life (evaluated by questionnaire).~   "
189825|NCT01079832|"~     RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less~     damage to normal tissue.~      PURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in~     treating women with advanced or recurrent gynecological malignancies.~   "
189826|NCT01079819|"~     The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of~     BMS-708163 administered as single and multiple doses in Chinese subjects~   "
189827|NCT01079806|"~     The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric~     patients with chronic hepatitis B virus infection~   "
189828|NCT01079793|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Ixabepilone may also make~     tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy~     after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone when~     given together with radiation therapy to see how well it works in treating patients with~     high-risk stage III prostate cancer after surgery.~   "
189830|NCT01079767|"~     RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients~     with advanced liver cancer and cirrhosis.~   "
189832|NCT01079741|"~     The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an~     annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have~     an excellent clinical outcome, patients diagnosed with advanced or recurrent disease,~     continue to have a high mortality rate, even with initial optimal surgical resection.~     Effective adjuvant strategies are needed to increase the time to progression and to decrease~     the recurrence rate. Immunotherapy has long been recognized as a potential therapy for~     melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to~     recognize and target minimal residual disease.~   "
189833|NCT01079728|"~     Stroke-associated pneumonia (SAP) constitutes a clinically relevant complication of stroke,~     because it increases the mortality and has a negative impact on the neurological prognosis of~     the patient.~      An early identification of patients at risk for SAP allowing an early initiation of~     antiinfective therapy may improve the prognosis. To date, no reliable prediction models or~     clinical scores for stroke-associated pneumonia exist. Recently, it was shown that parameters~     indicating an impaired immune function are associated with the subsequent occurrence of SAP~     and could therefore be used as predictors for SAP.~      This study will develop and prospectively validate a prognostic score to predict SAP based on~     clinical parameters. Furthermore, the study examines the prognostic properties of selected~     immune and infectious parameters for the prediction and diagnosis of SAP. The study will~     further address the question whether these infectious and immune parameters predict the~     3-month-outcome. In a subgroup of patients, MRI parameters on stroke size and localization~     will be assessed to investigate whether these parameters might allow prediction of SAP or the~     3-month-outcome.~   "
189834|NCT01079715|"~     The purpose of this study is to determine whether the administration of propranolol is~     effective in the treatment of the retinopathy of the prematurity.~   "
189835|NCT01079702|"~     In the investigators study the investigators combine everolimus, administrated twice daily at~     a fixed total dose of 10 mg continuously with capecitabine administered bid for 14 days~     followed by 7 days rest. In this study, capecitabine will be dose escalated.~   "
189836|NCT01079689|"~     The purpose of this study is to evaluate effects on the brain after complex somatosensory~     stimulation with acupuncture needle. EEG and fMRI measurements will be performed.~   "
189837|NCT01079676|"~     This study primary objective and endpoints are compare the efficacy of two products~     containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered~     non-inferior to the reference product.~   "
189838|NCT01079663|"~     The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate~     chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with~     Peri-Implantitis.~   "
189839|NCT01079650|"~     Thermal, or infrared, energy is the part of electromagnetic radiation that an observer~     perceives as heat. Infrared thermography allows us to visualize temperature distribution of~     the human body and has been used in medical practice since the 1950s. In current study we~     would like to examine the ability of infrared thermography to detect acute appendicitis,~     ovary torsion and inflammation, and testicular torsion and inflammation.~   "
189840|NCT01079637|"~     Randomized clinical trial (RCT) to compare treatment failure rates of surgical arthrodesis~     with MFB against cast treatment in patients suffering from early stage Charcot~     neuroarthropathy (CN) of the midfoot (Sella and Barrette stages 0, 1 or 2) within the first 2~     years after initial treatment. Treatment failure is defined as the occurrence of one or more~     of the following: 1. Amputation, 2. Occurrence of ulcer or worsening of existing ulcer, 3.~     Surgical intervention for correction of deformity after initial treatment. The secondary aims~     are to compare foot function, radiologic outcome, quality of life, complications and foot~     temperature between the two groups.~   "
189841|NCT01079624|"~     Academic phase 1 study which investigates the effects of the two incretin hormones~     glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying,~     appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin~     hormones not only stimulate insulin release but also inhibits gastric emptying. This effect~     can be utilized for further drug development.~   "
189842|NCT01079611|"~     Background: Estimates of central venous pressure (CVP) can be very helpful in guiding fluid~     therapy in the intensive care unit, operating room or emergency room. Current standard~     technique for CVP assessment is invasive, requiring insertion of a catheter into a~     subclavian, internal jugular or peripheral vein. Several ultrasound based and clinical~     methods have been described as potential non-invasive alternatives to assess CVP.~      Aim: To prospectively evaluate the accuracy of CVP assessment by a) inferior vena cava~     diameter and collapsibility b) internal jugular vein diameter c) compression sonography of a~     forearm vein and d) clinical assessment of peripheral vein collapse in comparison to invasive~     CVP measurement.~      Study design: single center, prospective observational study~      Patients and Methods:~      We will examine 77 consecutive patients with invasive venous access and invasive hemodynamic~     monitoring at the surgical intensive care unit (ICU). After obtaining informed consent,~     ultrasound examinations of the inferior vena cava, internal jugular vein and compression~     sonography of a forearm vein as well as clinical evaluation of peripheral vein collapsibility~     will be performed in a random sequence by different experienced examiner. Invasive CVP is~     recorded simultaneously to each measurement. Examiners are blinded to clinical parameters and~     results of previous CVP measurements.~      Primary endpoint: Accuracy of each non-invasive method to determine CVP defined by invasively~     measured CVP.~      Secondary endpoint: Comparison of the feasibility of each non-invasive method.~      Expected results: We hypothesize that sonographic measurement of inferior vena cava diameter,~     internal jugular vein diameter and compression sonography of a forearm vein as well as~     clinical assessment of peripheral vein collapsibility are reliable methods for CVP~     determination in comparison to invasive CVP measurement.~      Significance: The validation and comparison of sonographic / clinic CVP assessment would~     enable clinicians to choose an accurate non-invasive method to assess volume status which is~     an important adjunct in the management of many critically ill patients. The non-invasiveness~     of these methods broadens the feasibility to measure CVP and may guide fluid therapy in new~     patient populations.~   "
189843|NCT01079598|"~     The purpose of this study is to demonstrate that patients will improve the immediate~     treatment outcomes from successive radiofrequency ablation (RFA) of incompetent perforator~     veins (IPVs).~   "
189844|NCT01079585|"~     The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)~   "
189879|NCT01079104|"~     Patients with hepatic dysfunction are known to have a high mortality rate. Hepa Wash(R) is a~     newly developed liver and renal support system that is based on the use of recycled albumin~     dialysate. The new system has shown a high detoxification capacity in in-vitro and~     preclinical studies. The aim of the study is to evaluate the safety and efficacy of the Hepa~     Wash system in patients with hepatic dysfunction in the intensive care unit.~   "
190002|NCT01077466|"~     The purpose of this study is to study safety and efficacy of natalizumab treatment of primary~     and secondary progressive multiple sclerosis.~      This will be done by measuring the effect of treatment on inflammation in the CNS by means of~     osteopontin levels in the cerebrospinal fluid (CSF). Safety measures further includes~     physical and neurological examination,blood samples and MRI measures of disease activity.~   "
189845|NCT01079572|"~     Complications following total joint arthroplasty are rare, and the majority of follow-up~     visits are routine. The technology now exists to conduct annual follow-up assessments without~     having to physically see the patient.~      This study will investigate the cost-effectiveness of web-based follow-up assessments~     compared to standard in-clinic follow-ups. We will also assess patient satisfaction,~     preference, and the validity of the web-based follow up assessments. Patients coming up to~     their 1 year follow-up or greater will be randomized to either the web-based group or the~     usual care group.~      Web-based patients will complete all questionnaires using an online database system, and have~     their x-ray taken at their local radiology facility. The surgeon will review radiographs~     online. If there are any concerns with the x-ray or responses to questionnaires, arrangements~     will be made for the patient to be seen at the clinic. Patients in the Usual Care group will~     come into the clinic for their follow-up assessment and have their x-ray taken at University~     Hospital as usual.~      Online assessment could significantly decrease wait times in orthopaedic clinics, as well as~     increase availability for OR time and new consultations. This approach could also potentially~     reduce patient burden by decreasing travel distances, financial burden and time requirements.~   "
189846|NCT01079559|"~     Rationale: Infection following total knee replacement (TKA) is a devastating complication~     that usually requires prosthesis removal, hospitalization while the infection is eradicated,~     and a second surgery to implant a revision prosthesis. For primary TKA, prophylactic~     antibiotic-loaded cement (ABC) may not only reduce the rate of infection it may also reduce~     the rate of revisions due to implant loosening. Current controversy about the use of ABC~     exists around the world. Without a definitive trial, patients will be exposed to a treatment~     of uncertain efficacy that may cause antibiotic resistant bacterial strains and will~     certainly generate high costs to the healthcare system. Purpose: To determine, 1) the extent~     to which ABC compared to regular cement reduces the infection rate in patients over the first~     two years following TKA and, 2) the resource use implications associated with the use of ABC~     for TKA. Methods: This is a randomized clinical trial in which 8,800 patients with undergoing~     primary TKA are allocated to either Simplex™ P with Tobramycin or Simplex™ P bone cement. We~     will exclude patients with a prior joint infection, an allergy to tobramycin, and those with~     no fixed address. All patients will be administered IV antibiotics immediately prior to~     surgery. Patients and surgeons will be blind to group allocation. The primary outcome measure~     is infection. Follow-up visits will take place at 6 weeks and 3, 12 and 24 months~     postoperative. A blinded adjudicator will review all reported infections and determine~     whether the putative infection is a study event. Blinded radiologists will interpret the 2~     year series of radiographs for each patient. We will compare the rates of infection and~     implant loosening between the two treatment groups using survival analyses. This study~     includes a full economic analysis.~   "
189847|NCT01079546|"~     The rationale for this study proposal is derived from previous case series demonstrating that~     up to 60% of patients with HNSCC, especially in the oropharynx are associated with high risk~     HPV infection.~      In this study, we will characterize the association between HPV infection and HNSCC in Israel~     and establish a program for its diagnosis and management based on HPV as a biomarker. The~     rationale for the proposed research is that once it is known which types of HPV are~     associated with HNSCC, this information can be used to direct diagnosis and screening effort~     to high risk population. Our approach is based on establishing a multicenter consortium of~     leading researchers that will establish a joint database of demographic, clinical and~     biological data from various regions in Israel. For this we have assembled a~     multidisciplinary research team with the scope and breath (surgical oncology, pathology,~     virology and molecular biology) needed to complete all phases of the research successfully.~     The research will be coordinated and performed at the Applied Cancer Research Laboratory, Tel~     Aviv Sourasky Medical Center. The patients will be recruited from 7 tertiary medical centers~     in Israel: Ichilov, Bellinson, Hadassa, Rambam, Soroka, Sheba and Nazeret..~   "
189848|NCT01079533|"~     Initiation of colon cancer screening in veterans is a theory-based stepped intervention to~     increase first time colorectal cancer screening (CRCS) among male and female veterans age 50~     and over.~   "
189849|NCT01079520|"~     Accurate staging of the mediastinum is essential to evaluate prognosis in non-small cell lung~     cancer and to devise an appropriate treatment plan. Mediastinal staging by surgical~     techniques (mainly cervical mediastinoscopy) is considered to be the gold standard, although~     surgical staging is invasive, requires general anesthesia, and is subject to potential~     serious complications. Endobronchial ultrasound (EBUS)-transbronchial needle aspiration~     (TBNA) is a new modality for the evaluation of mediastinal and hilar lymph node metastasis~     from lung cancer. Compared to other diagnostic methods, EBUS-TBNA is a real-time procedure~     that enables multiple biopsies with high-quality histologic cores under local anesthesia.~     However, there have been few data on the head-to-head comparisons of mediastinoscopy and~     EBUS-TBNA. The aim of this prospective study is to determine the sensitivity, specificity,~     positive predictive value, negative predictive value, and accuracy of EBUS-TBNA and~     mediastinoscopy in identifying N2 and N3 lymph node for patients with non-small cell lung~     cancer.~   "
189859|NCT01079377|"~     This study will examine the interaction of psychological factors and serious overweight to~     determine if particular patterns of psychological symptoms are helpful in predicting outcomes~     of weight loss surgery.~      Patients from the Center of Adolescent Bariatric Surgery (CABS) program at the Morgan Stanley~     Children's Hospital of New York Presbyterian will be asked to participate in a longitudinal~     prospective study of psychopathology among severely obese adolescents. Additionally, the~     psychological symptoms of this group will be compared to other treatment-seeking obese~     adolescents.~      The investigators hypothesize that:~        1. Adolescents receiving bariatric surgery will demonstrate significant reductions in body~          weight, eating pathology, and other symptoms after receiving bariatric surgery.~        2. Adolescents enrolled in the bariatric surgery program will report more psychological~          problems than other treatment-seeking obese adolescents.~   "
189933|NCT01078376|"~     The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose~     of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.~   "
190016|NCT01077284|"~     The purpose of this study is to determine the efficacy of febuxostat, once daily (QD),~     compared to allopurinol or placebo in patients with excessive amounts of uric acid in their~     urine and who have recently had kidney stones.~   "
189850|NCT01079507|"~     Acute lymphoblastic leukemia (ALL) is not a single disease, but a composite of heterogeneous~     subgroup. Accordingly, more sophisticated classification in ALL is essential to achieve~     further improvement of treatment outcomes. However, only a few genetic markers are revealed~     to have significant prognostic implications in ALL patients. The current study is designed to~     stratify the ALL patients according to their prognosis and to predict their outcomes by a~     pharmacogenetic approach. A predictive model will be generated from 130 genotypes in adult~     ALL patients diagnosed at the Samsung Medical Center (SMC), Sungkyunkwan University School of~     Medicine, Seoul,Korea between 1994 and 2008. The validation of the predictive model will be~     performed using an independent external cohort of ALL patients.~        1. Definition of the cohort: two hundred ALL patients from the SMC as a test set, another~          100 patients from the SMC as a first validation set, and another 150 independent~          external patients as second external validation set. DNAs will be extracted and stored~          from patients' samples collected at the time of diagnosis.~        2. In the test set, genotypes will be determined using a MALDI-TOF based platform~          (Sequenom, San Diego, CA, USA) for 130 SNPs of the candidate genes involved in DNA~          repair pathway, drug metabolism/transport pathway and folate metabolism pathway.~        3. Bioinformatic analyses will be performed to identify around 13 genotypes (10%) having~          strongest predictive significance out of these 130 SNPs in terms of their treatment~          outcomes, drug toxicity and prognosis in the test set.~        4. These 13 genotypes will be validated in the first cohort of 100 ALL patients using a~          multivariate Cox's proportional hazard model.~        5. The predictive model will be built up based on Cox's proportional hazard model derived~          from 13 candidate genotypes and clinical risk factors.~        6. The predictive model based on pharmacogenetic information will be validated again in the~          second, independent external cohort of 150 ALL patients.~      Definite prognostic value was not established for genetic or molecular markers in acute~     lymphoblastic leukemia (ALL) except BCR/ABL fusion gene. The current study attempts to build~     up a predictive model based on single nucleotide polymorphisms (SNPs) with pharmacogenetic~     approach using 130 genotypes in the multiple candidate pathways such as DNA repair pathway,~     drug metabolism / transport pathway and folate metabolism pathway. The predictive model based~     on SNPs will be generated and validated with respect to treatment outcomes, drug toxicity and~     prognosis in adult ALL patients.~      The present study will demonstrate that: 1) Pharmacogenetic information derived from SNPs~     involved in the DNA repair pathway, drug metabolism/transport pathway and folate metabolism~     pathway, is helpful to predict the treatment outcomes, drug toxicity and prognosis in ALL~     patients; 2) Predictive model derived from pharmacogenetic information will be effective and~     reasonable approach to stratify ALL patients according to their clinical outcomes; 3) The~     SNP-based predictive model could be reasonably applied to the treatment of ALL patients, thus~     becoming a basis for further improvement of treatment outcome; 4) Finally, this project will~     enhance and facilitate the pharmacogenetic research in the hematology area, thus make the~     team to lead the pharmacogenetic research in the world.~   "
189851|NCT01079494|"~     Background: studies have demonstrated the crucial role of clinical pharmacists as integrated~     part of heath care team. Not only in Jordan but also in the Middle East region, clinical~     pharmacy practice is not well established. This current study is the first to evaluate~     physicians - pharmacists' collaborative approach to uncontrolled blood pressure in Jordan and~     the Middle East.~   "
189852|NCT01079481|"~     The objective of this phase I study is to determine the maximum tolerated dose (MTD) of~     combination therapy of paclitaxel and everolimus in small cell lung cancer patient with~     previous treatment history.~   "
189853|NCT01079468|"~     Transient cognitive changes after surgery may be due to many different factors. It is~     estimated that between 5-29% of patients undergoing orthopedic surgery experience a transient~     decline in their cognition. Fat and bone marrow debris embolization can cause cognitive~     changes if they enter the cerebral circulation in significant numbers. During total hip~     arthroplasty the placement of the femoral stem leads to a rise in intramedullary pressure~     which can cause fat and bone marrow debris to embolize into the systemic circulation. Total~     hip resurfacing arthroplasty avoids entrance into the femoral canal. The purpose of this~     study is to assess transient cognitive changes after total hip arthroplasty and compare them~     to patients undergoing total hip resurfacing arthroplasty. We hypothesize that patients~     undergoing total hip resurfacing arthroplasty will experience less transient cognitive~     changes due to the avoidance of violating the femoral canal during the procedure.~   "
189854|NCT01079455|"~     Abstract Background: The effect of intra-articular treatment of hip osteoarthritis with~     hyaluronic acid in the hip joint is not based on large randomized controlled trials.~     Hyaluronic acid is a well established treatment for osteoarthritis of the knee.~      Methods: Randomized controlled trial with three-armed parallel-group design. The patients~     meeting the inclusion criteria will be randomized into one of the following groups:~     infiltration of the hip joint with hyaluronic acid, with corticosteroids or with bupivacaine~     0,125%.~      Pain VAS, Harris Hip Score and HOOS were scored during follow-up. The patients will be asked~     to determine their situation as worse, stabile or better then at the time of enrollment.~     There will be asked if they use painkillers and if they have complications/adverse events.~     These outcome measure instruments will be used at the time of enrollment in the study prior~     to any injection, and then again at six weeks, 3 and 6 months after the initial injection.~     The six-month follow-up period begins for all patients on the date the first injection will~     be administered.~   "
189855|NCT01079442|"~     The purpose of the investigators study is to investigate the effects of coffee on the return~     of bowel function and appetite, length of hospital stay, and complications after elective~     open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to~     first bowel movement.~   "
189856|NCT01079429|"~     The purpose of this study is to describe DNA copy number variations and gene expression~     profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance~     (MGUS) and smoldering multiple myeloma (SMM). The final objective is to search for~     correlations with the risk of progression in order to establish a predictive model of early~     malignant transformation.~   "
189857|NCT01079416|"~     Esophageal capsule endoscopy is sedation-less alternative to upper endoscopy for evaluating~     esophageal lesions and potentially other upper gastrointestinal lesions. The purpose of this~     study was to determine whether esophageal capsule endoscopy is convenient and accurate as~     upper endoscopy for detection of esophageal varices and related lesions.~   "
189858|NCT01079390|"~     In this proposal, we plan to dynamically investigate brain response to verum acupuncture (of~     two different doses) and placebo acupuncture, using a paradigm that approximates clinical~     acupuncture practice across multiple treatment sessions in knee osteoarthritis (OA) patients.~     This proposal aims to: 1) characterize session-to-session brain responses to verum / sham~     acupuncture treatment (reliability of response) for OA patients, and 2) investigate how~     different doses of acupuncture influence brain response and acupuncture efficacy (impact of~     dose). The findings of this project will deepen our biological understanding on why and how~     acupuncture can treat chronic pain and what happens in the brain during the multiple-session~     acupuncture treatment.~   "
189876|NCT01079143|"~     Recently, early biomarkers of renal interstitial fibrosis have been identified, amongst them~     de novo expression of vimentin by tubular epithelial cells, which is an intermediate~     filament, and the translocation of beta-catenin into their cytoplasm. These markers, when~     present, suggest that the epithelial cell undergoes a phenomenon well known as epithelial to~     mesenchymal transition (EMT) and could behaves like a myo-fibroblast. EMT is highly~     instrumental in several models of tissue fibrosis, including in the kidney. Actually, it has~     not only been demonstrated that these markers are detectable in the renal graft at an early~     time point post-transplant (i.e. as soon as three months), but also that the intensity of~     their expression correlates with the progression of interstitial fibrosis of the graft~     between 3 and 12 months~   "
189860|NCT01079364|"~     Primary Objective:~      To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one~     injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed~     insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint.~      Secondary Objective:~        -  To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status,~          DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction~          Questionnaire)~        -  To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose)~          and proportion of patients with a HbA1c <7%~        -  To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight~          gain and injection site reactions)~        -  To determine the total insulin dose, average insulin glargine, insulin glulisine and~          premixed insulin dosages.~   "
189861|NCT01079351|"~     The purpose of this study is to assess the safety, tolerability and steady-state~     pharmacokinetics of intravenous (IV) Carbamazepine (CBZ) infusions relative to orally~     administered CBZ in adult patients with epilepsy.~   "
189862|NCT01079338|"~     This study aims to establish whether the protein composition of healthy males contribute to~     their sensitivity to the bitterness of caffeine.~   "
189863|NCT01079325|"~     The purpose of the study is to evaluate the clinical effects of the investigational drug,~     SB-509, in subjects with diabetic neuropathy.~   "
189864|NCT01079312|"~     Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde~     cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality.~     Delivery of propofol and short-acting potent opioid analgesic using a self-administration~     device (patient-controlled sedation, PCS) could be another option for this purpose.~     Comparative studies with PCS for ERCP are lacking.The main objective of this prospective~     randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist~     managed propofol sedation during ERCP.~   "
189865|NCT01079299|"~     This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the~     effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous~     ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing,~     healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount)~     will be compared between the IPC-treated group (IPC plus standard compression)and control~     (standard compression alone).~   "
189866|NCT01079286|"~     In the present study the investigators want to explore the safety, pharmacokinetics, and~     activity of the combination of temsirolimus and nelfinavir, both agents with PI3K /Akt/mTOR~     inhibiting activity, in patients with advanced malignancies.Temsirolimus has proven anti~     tumoral activity by mTOR inhibition. Nelfinavir is a potential inhibitor of Akt. Combining~     both agents might prevent upregulation of the P13k pathway and increase the anti-cancer~     activity of temsirolimus. The strong CYP3A4 inhibition of nelfinavir and the dependence of~     temsirolimus on CYP3 A4 metabolism makes a dose finding study essential. The investigators~     will also look at the prospective value of biomarkers of activity and the outcome of the~     treatment.~   "
189867|NCT01079273|"~     The purpose of this study is explore the antibody and cell mediated immune responses to one~     injection of Focetria™ pandemic influenza vaccine in healthy adults aged 18-60 years.~   "
189868|NCT01079260|"~     This study aims to investigate the efficacy of high energy, low volume oral nutritional~     supplements (ONS) compared to equivalent standard ONS (control) to maximize nutrient intake,~     compliance, gastro intestinal tolerance and function, in participants at risk of~     malnutrition.~   "
189869|NCT01079247|"~     The purpose of this study is to find out if burn injured patients do better receiving fewer~     blood transfusions than what is traditionally given. We traditionally provide blood~     transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood~     cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter~     and is the standard measurement used to indicate the level of red blood cells in your blood).~     However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8~     g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above,~     would reduce the occurrence of blood infection, duration on the respirator and length of~     hospital stay, yet would achieve similar survival in both groups.~   "
189870|NCT01079234|"~     This trial is conducted in Europe and in the United States of America (USA). The aim of this~     trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with~     type 1 diabetes.~   "
189871|NCT01079221|"~     COPD patients have a reduced exercise tolerance due to a ventilatory limitation.~      Several studies have shown altered skeletal muscle function. The investigator will study the~     physiological response to knee-extensor exercise in COPD patients.~   "
189872|NCT01079208|"~     The purpose of this study is to assess the growth of infants fed a novel starter formula~     containing synbiotics and different protein levels, compared to a standard starter infant~     formula, during the first four months of life.~   "
189873|NCT01079195|"~     The aim of this post-marketing observational study (PMOS) is to provide data on the~     effectiveness and tolerability of Tarka in patients with a high risk of developing diabetes~     mellitus, as prescribed by the physicians in a community setting and in accordance with the~     terms of the local marketing authorization. The following specific questions will be~     addressed:~        -  Effectiveness of Tarka in lowering the blood pressure in hypertensive patients being at~          high risk of developing diabetes, not controlled on single-drug therapy.~        -  Tolerability of Tarka as assessed by withdrawal rates.~   "
189874|NCT01079182|"~     The research question explored in this study was whether the effectiveness and safety of~     adalimumab in participants with ankylosing spondylitis was maintained during long-term~     therapy in routine clinical practice in Germany.~   "
189875|NCT01079169|"~     The purpose of this study is to establish whether cranberry capsules reduce rates of urinary~     tract infections during initial rehabilitation immediately after spinal cord injury.~   "
189877|NCT01079130|"~     This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo~     and salmeterol~   "
189878|NCT01079117|"~     To compare the effectiveness of slow release oral morphine treatment in patients that~     previously have been treated with methadone~   "
189880|NCT01079091|"~     Patients with compensated chronic liver disease who have an episode of acute deterioration of~     liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate.~     Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of~     recycled albumin dialysate. The new system has shown a high detoxification capacity in~     in-vitro and preclinical studies. The aim of the study is to evaluate the safety and efficacy~     of the Hepa Wash system in patients with acute-on-chronic liver failure in the intensive care~     unit.~   "
189881|NCT01079078|"~     The study was conducted as an open label, balanced, randomised, two-treatment, two-period,~     two-sequence, single dose, crossover bioavailability study comparing acetaminophen extended~     release gelcaps 650 mg (containing acetaminophen 650 mg) of OHM Laboratories Inc. with~     TYLENOLÒ arthritis pain caplets 650 mg (containing acetaminophen 650 mg) of McNeil Consumer &~     specialty Pharmaceuticals in healthy, adult, human, male subjects under fed condition.~   "
189882|NCT01079065|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP~     20 mg manufactured by OHM Laboratories with Pepcid® AC Acid reducer famotidine tablets 20 mg~     (containing famotidine 20 mg) distributed by Johnson & Johnson. Merck Consumer Pharmaceutical~     Co. Fort Washington, PA 19034 USA under fasting conditions.~   "
189883|NCT01079052|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP~     20 mg manufactured by OHM Laboratories with Pepcid® AC Acid reducer famotidine tablets 20 mg~     (containing famotidine 20 mg) distributed by Johnson & Johnson. Merck Consumer Pharmaceutical~     Co. Fort Washington, PA 19034 USA under fed conditions.~   "
189884|NCT01079026|"~     prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for~     radiculopathy with HNP~   "
189885|NCT01079013|"~     The study hypotheses is that the introduction of dose escalated treosulfan, in substitution~     to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while~     improving disease eradication in patients with lymphoid malignancies not eligible for~     standard transplantation.~   "
189886|NCT01079000|"~     The purpose of this study is to determine if evidence-based guidance on follow-up care and~     self-management provided to PCPs and patients, respectively, reduces relapses within 90 days~     for acute asthma (primary outcome). Secondary outcomes will include follow-up visits with the~     primary care provider, patients' quality of life and cost-effectiveness indicators.~   "
189887|NCT01078987|"~     The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing~     dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).~   "
189888|NCT01078974|"~     Pomalidomide is a newly discovered drug that may stop cancer cells from growing abnormally.~     Pomalidomide may also stimulate the immune system to fight the cancer cells and possibly~     improve the effectiveness of dexamethasone and rituximab to fight the Waldenstrom's~     Macroglobulinemia (WM) cancer cells. This drug have been used in multiple myeloma and~     information from these other research studies suggests that Pomalidomide may help to reduce~     or prevent the growth of cancer cells.~   "
189889|NCT01078961|"~     This research study involves the use of two investigational drugs: sorafenib and bortezomib.~     Sorafenib is designed to stop the growth of cells caused by changes associated with cancer.~     Bortezomib is designed to stop cancer cells from getting rid of waste products. This causes~     the cells to build up toxic levels of waste that leads to cell death. In the laboratory, the~     combination of sorafenib and bortezomib has been shown to fight cancer cells better than~     either drug alone. We are looking to determine if the combination of sorafenib and bortezomib~     is a safe treatment for patients with advanced melanoma. The effectiveness of this~     combination will also be assessed.~   "
189890|NCT01078948|"~     The project will investigate the use of a novel neuromodulatory technique, transcranial~     direct current stimulation (tDCS) in the treatment of patients with major depressive~     disorder.~      Hypothesis 1: Active tDCS will improve depressive symptomology to a significantly greater~     degree than sham treatment.~      Hypothesis 2: Active tDCS will be well tolerated and free of major side effects.~   "
189891|NCT01078935|"~     Fifty patients will get probiotics (109 bacteria [L. acidophilus, B. bifidum, S.~     thermophilus, L. rhamnosus, L. casei] in 2 capsules) and half will get placebo (2 capsules~     that look the same like the probiotic capsules and will contain microcrystalline cellulose,~     artificial brown color, magnesium strearate, and silica dioxide). The patients and the staff~     will be blinded to the identity of the study medications.~      Each patient and volunteer will get the study medication for 6 weeks and will be evaluated~     twice - before enrollment and after 6 weeks of treatment. Routine clinical management will~     continue - with regular treatment as needed.~      Each individual will be studied for changes in biochemical inflammatory and immunological~     markers and changes in flow medicated diameter that will be measured by the brachial artery~     method (that is evaluating endothelial function). Every patient will be evaluated for his/her~     ability to produce endothelial progenitor stem cells (EPCs).~   "
189892|NCT01078922|"~     This is a phase II open label study that looks at the efficacy and toxicity of Ofatumumab~     monotherapy in patients with relapsed and/or refractory diffuse large B-cell lymphoma~     (DLBCL). Patients will receive weekly infusions of Ofatumumab of 1000 mg each for 8 weeks~     (induction phase) followed by continuing the study drugs every other week in subsequent~     cycles (maintenance phase). Each 4 weeks of therapy will be calculated as one cycle.~     Treatment will continue until disease progression, toxicity, patient's withdrawal, or~     investigator's discretion.~   "
189893|NCT01078909|"~     The purpose of this study is to determine the lowest effective dose of EPA + DHA (300, 600,~     900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the~     inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the~     production over time of several inflammatory markers.~   "
189894|NCT01078883|"~     The purpose of our study is to investigate the association between respiratory muscle~     performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory~     morbidity rate, and 1-year mortality in patients with primary stage IIIb and IV lung cancer.~   "
189974|NCT01077830|"~     The purpose of this extension is to observe the incidence rates of cancer, total mortality,~     and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial~     (2004_050, MK0653A-043; NCT00092677).~   "
189895|NCT01078870|"~     The project is a double-blind, randomized, placebo controlled clinical trial comparing 3~     groups of schizophrenic subjects, who have no less than moderate degree of negative symptoms~     and carry the homozygous risk genotype (TT) of NRG1-P3, each group having 30 individuals,~     treated by add-on with escitalopram 10-20 mg/day, duloxetine 30-60 mg/day, and placebo. The~     treatment duration is 8 week. The investigators will evaluate the Positive and Negative~     Symptom Scale (PANSS) at baseline, Day 14, Day 28, Day 42, and Day 56. The primary outcome of~     interest will be the differences of averaged reduction of negative symptom scores among 3~     groups and an average decrease of 2 or more in the negative symptoms will be indicated as~     improvement.~   "
189896|NCT01078857|"~     Neurological dysfunction is a common complication of late stage chronic kidney disease (CKD)~     and peripheral nerve system is often involved in such complication. Sensory disturbances such~     as paresthesia and hypoesthesia are the predominant symptoms in uremic polyneuropathy and it~     is traditionally thought the uremic polyneuropathy mainly involve large-diameter sensory~     nerves. However in uremic patients the abnormal thermal thresholds, the sensory symptoms like~     numbness, burning, paradoxical heat, cold or freezing, and pain, and the frequent symptoms of~     autonomic dysfunction suggest that small-fiber neuropathy should be a clinical entity in~     patients of CKD. But there are still few investigations with emphasis on the changes of~     small-fiber nerves in CKD, and little is known about the characteristics and mechanism of~     small-fiber neuropathy in CKD. Skin biopsy with evaluation of epidermal nerve density and the~     morphology of epidermal nerves and the subepidermal nerve plexus is an effective and~     minimally invasive test for assessment of small-fiber neuropathy. Contact heat evoked~     potential (CHEP) recording the brain responses evoked by contact heat stimuli on the skin is~     a non-invasive technique to investigate the thermo-nociceptive pathways mediated by~     small-fiber nerves. In the current study, we will use an integrated approach by combining the~     skin biopsy, quantitative sensory testing, autonomic function tests, and CHEP to investigate~     the pathological, psychophysical and physiological aspects of small-fiber neuropathy in~     patients of CKD. The aims of the current study is to address the following issues: (1) the~     changes of small fiber nerves in uremia and CKD of different stage; (2) the correlation of~     skin innervation with clinical manifestations, thermal thresholds, and autonomic function;~     (3) the influence of dialysis therapy, the type of dialysis therapy, or renal transplantation~     on the small fiber neuropathy in uremia; (4) the roles of blood chemical substances, metals,~     and endocrine profiles on the development of small-fiber neuropathy; (5) the relationship~     between the small-fiber neuropathy and pruritus or restless leg syndrome; and (6) the~     pathological and physiological correlates of painful symptoms by skin biopsy and CHEP in CKD~     related neuropathy. The results of the study will provide important insights in the~     understanding of the pathogenesis, and the prevention and new treatments of small-fiber~     neuropathy in CKD.~   "
189897|NCT01078844|"~     The purpose of this study is to see if memantine is helpful in managing problematic symptoms~     in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise~     specified (NOS).~   "
189898|NCT01078831|"~     The purpose of this study is to examine changes in ventilation and airway pressures during~     conventional bronchoscopy of intubated patients.~   "
189899|NCT01078818|"~     Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary~     bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The~     purpose of this study was to compare the clinical efficacy of intravenous and oral iron in~     anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular~     surgery under extracorporeal circulation.~   "
189900|NCT01078805|"~     The purpose of this study is to evaluate the long-term effectiveness, safety, and~     tolerability of FORTEO in a larger, more diverse real world population than studied in~     clinical trials~   "
189901|NCT01078792|"~     To determine the possible association of prothrombin fragments 1+2 elevation with incidents~     of pulmonary embolism in patients with COPD exacerbation.~   "
189902|NCT01078779|"~     A randomised controlled trial to determine the efficacy of chloroquine for the prevention of~     influenza~   "
189903|NCT01078766|"~     The combination of the constraint-induced movement therapy (CIMT) method as a complement to~     hand arm bimanual training (HABIT) will improve the frequency and quality of cooperative hand~     use and function in children with hemiplegic CP.~   "
189904|NCT01078753|"~     This is multi-center, randomized, placebo-controlled, parallel-group, double-blind,~     dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin~     orally lyophilisate for the treatment of nocturnal enuresis with decreased nighttime urinary~     osmolality.~   "
189905|NCT01078740|"~     This is a pilot study. The purpose of the study is to facilitate the development of a new~     biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) function using rectal~     tissue.~   "
189906|NCT01078727|"~     Improving upper extremity movement and function in patients with stroke has been one of the~     primary goals for patients and rehabilitation professionals. Thermal stimulation (TS) had~     been first found by a domestic research group to be effective to facilitate sensory and motor~     recovery in patients with stroke within a month. However, the immediate and long-term effects~     of TS and the mechanism of brain plasticity in patients with stroke for more than three~     months (golden recovery stage) remain unknown. Thus, we will design a single-blind randomized~     controlled trial to investigate the immediate and long-term effects of TS in patients with~     stroke at subacute and chronic stages.~   "
189907|NCT01078714|"~     The purpose of this study is to determine if a treatment by bumetanide presents an efficiency~     at the level of the neuronal maturation in the autism~   "
189908|NCT01078701|"~     The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of~     GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus.~      This study is also performed to assess safety, tolerability and pharmacokinetics (shedding)~     of a single dose of GHB11L1 administered by liquid nasal spray.~   "
189909|NCT01078688|"~     Evaluation of the frequency of limitation of activity, depending on gender and age-group, in~     patients with persistent asthma consulting a general practitioner~   "
189910|NCT01078675|"~     This study is being carried out to see if the study medication, rosuvastatin, is effective in~     treating familial hypercholesterolaemia in children and adolescents, and to determine the~     long term (over 2 years) safety, tolerability and efficacy of the study medication in these~     patients.~      This study will also measure levels of drug in the blood and see how well it is tolerated.~     This is known as pharmacokinetic (PK) analysis.~      At baseline only a small number of patients will participate in a single dose PK phase over~     24 hours.~      In order to see if this medication works, a control group of healthy siblings will help the~     researchers to compare certain results.~   "
189911|NCT01078662|"~     To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed~     genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response~   "
189912|NCT01078649|"~     The purpose of this study is to determine the safety profile and the maximum dose of Debio~     1143 (AT-406) that can be given to humans. This study is also designed to measure how much~     Debio 1143 (AT-406) gets into the blood stream (pharmacokinetics), and how Debio 1143~     (AT-406) interacts with proteins related to cancer that the drug is targeted to affect~     (pharmacodynamics).~   "
189913|NCT01078636|"~     The purpose of this study is to build upon the information obtained in the original~     Alzheimer's Disease Neuroimaging Initiative (ADNI1), to examine how brain imaging technology~     can be used with other tests to measure the progression of mild cognitive impairment (MCI)~     and early Alzheimer's disease (AD). ADNI-GO seeks to define and characterize the mildest~     symptomatic phase of AD, referred to in this study as early amnestic MCI (EMCI). This~     information will aid in the early detection of AD, and in measuring the effectiveness of~     treatments in future clinical trials.~   "
189914|NCT01078623|"~     The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations~     of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol~     fumarate, all administered BID in patients with stable, moderate to severe COPD.~      Every treatment period is 14-days long and there is a 7-days wash-out period in between them.~     The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow~     up contact 14-days after last treatment dose.~   "
189915|NCT01078610|"~     Safety and effectiveness, quality of life and work productivity of Humira in patients with~     psoriatic arthritis in clinical routine.~   "
189916|NCT01078597|"~     A key challenge in the management of patients with Rheumatoid Arthritis (RA) is the early~     identification of patients that are at risk of developing a severe and destructive disease. A~     better understanding of prognostic factors such as anti-CCP and anti-MCV biomarkers, is~     needed in order to better identify patients with early Rheumatoid Arthritis that are at risk~     of developing aggressive diseases. At the present time the prevalence of one such biomarker,~     namely anti-MCV, is unknown in an Irish Rheumatoid Arthritis population. This study will~     establish the prevalence of anti-MCV in such a population.~      A second challenge in the management of Rheumatoid Arthritis patients is the determination of~     the best treatment strategy tailored to individual patient's needs. In routine practice,~     treatment approaches are based on the patient history and the availability of clinical~     parameters, such as a positive anti-CCP status, which is associated with worst prognostics.~     At the present time, the impact of a positive anti-CCP status on patients' management has not~     been formally studied in Ireland The proposed study will provide data on the prevalence of~     anti-MCV in an Irish RA population and the use of anti-CCP and other clinical parameters~     currently used in routine care. In addition, the present study will evaluate the impact of~     the known anti-CCP status on patients' management. Associations between the anti-CCP and~     anti-MCV status and clinical outcome measures will be assessed.~      The results from the present study will have significant implications not only for the~     individual patient but also from the societal perspective, since it will enhance the overall~     understanding and applications of different treatment approaches based on individual~     patients' profile.~   "
189917|NCT01078584|"~     The in-MAU-tion study is conducted to determine the percentage of hypertensive participants~     with or without diabetes reaching CHEP (Canadian Hypertension Education Program) defined~     blood pressure targets. Additionally, the study assesses change in renal function~     (microalbuminuria, estimated glomerular filtration rate) in hypertensive participants treated~     with trandolapril (Mavik®) and examines patient satisfaction with trandolapril (Mavik®)~     therapy.~   "
189918|NCT01078571|"~     Adalimumab is one of the pharmacological treatments for rheumatoid arthritis (RA) of more~     recent marketing authorization, and as a result of this, there are only efficacy and safety~     data from clinical trials with controlled conditions.The study will evaluate the safety and~     effectiveness of adalimumab in the common clinical practice of RA treatment in Spain, with~     several types of patients showing concomitant treatments or diseases and compliance. Among~     the tumor necrosis factor antagonists safety studies, adalimumab safety has been the less~     investigated in the common clinical practice because of, as a result of its recent marketing,~     it was not included in the BIOBADASER (Data Base for Biological Products in Spain,~     Rheumatology Spanish Society), Biologic Products Database of the Spanish Society of~     Rheumatology ) in which was determined an association between infliximab therapy and the risk~     of developing active tuberculosis. To ensure the maintaining of the strict common physician~     practice (no prescription induction), and following the recommendations of the SER (Sociedad~     Española de Reumatología, Spanish Society of Rheumatology) consensus documents, it will be~     selected only those patients that were already in treatment with adalimumab (HUMIRA),(except~     patients involved in clinical studies with Adalimumab), and had shown good response, or those~     that fulfilled treatment indication in accordance with the SER recommendations and following~     the Summary of Products Characteristics of adalimumab (HUMIRA).~   "
189919|NCT01078558|"~     This a five year, post-marketing observational study to follow-up patients with rheumatoid~     arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA~     (adalimumab).~   "
189920|NCT01078545|"~     The purpose of the study is to determine the influence of GnRH (gonadotropin releasing~     hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration~     on intensity of lower urinary tract symptoms (LUTS) in patients with diagnosed locally~     advanced and/or metastatic prostate cancer and LUTS.~   "
189921|NCT01078532|"~     This project seeks to improve health care outcomes in complex patients with cardiovascular~     disease (CVD) or who are at high risk for developing CVD by promoting patient~     self-management. This will be accomplished in 4 diverse, large primary care practices through~     the following 3 aims: (1) develop a patient-specific, active component to an existing~     electronic PHR directed towards patients with complex illnesses that is designed to reduce~     the risk of cardiovascular disease, (2) conduct a randomized controlled trial of the~     effectiveness of passive and active PHRs for improving adherence and clinical outcomes of~     complex patients in an ambulatory environment, and (3) enumerate the barriers and~     facilitators to implementation and use of an PHR among providers and patients in an~     ambulatory setting. To accomplish the aim 1, a users group will be assembled to determine~     which potential features of an 'active PHR' would be most acceptable and useful to them. To~     accomplish the 2nd aim, 1,000 patients with complex chronic disease leading to increased~     cardiovascular risk (i.e., CVD or 2 of the 4 conditions of hypertension (HTN), diabetes~     mellitus (DM), or hyperlipidemia requiring at least one medication for control) will be~     randomized to a passive PHR (n=500), or an active PHR (n=500) at 4 sites where the PHR~     currently is installed and in use. Outcomes to be assessed include improvement in control of~     risk factors (e.g., blood pressure), frequency of compliance with testing guidelines (e.g.,~     annual dilated retinal exams in DM), and clinical outcomes (e.g., myocardial infarction,~     hospitalizations). Aim 3 will be accomplished by surveying all participants using the PHR,~     along with nurses and physicians at the study sites, and by conducting focus groups of PHR~     participants, nurses, and physicians to determine the most useful features of the PHR and to~     barriers and facilitators of use.~   "
189975|NCT01077817|"~     This is a 2-phase retrospective database study, using both case-cohort and inception~     (intention-to-treat) cohort analyses to evaluate any association between oral treatments for~     osteoporosis and the risk of esophageal cancer in women.~   "
189922|NCT01078519|"~     Maternal intra-partum fever commonly complicates the process of labour. Its occurrence is~     often regarded as being synonymous with the presence of chorioamnionitis. This inevitably~     results in the administration of antibiotics to the affected mother. Review of the literature~     however suggests that this approach is not always appropriate. Non-infective causes of this~     condition that are often overlooked include the use of epidural analgesia for pain relief,~     normal thermal physiological changes in women not using any form of analgesia and delivery in~     an overheated room. Women with certain risk factors such as nulliparity and a long latent~     phase of labour are also more prone to developing maternal intra-partum fever. Irrespective~     of its aetiology, maternal intra-partum fever carries risks both for the mother and her~     unborn child. Putting more thought into the care of these patients will go a long way in~     reducing the maternal and neonatal morbidity associated with this complication.The combined~     spinal-epidural (CSE) technique has been introduced in an attempt to reduce these adverse~     effects. CSE is believed to during labour provide more rapid onset of analgesia than epidural~     analgesia, The incidence of fever is significantly lower with CSE technique.~   "
189923|NCT01078506|"~     Intracranial aneurysm (localized dilatation in weakened blood vessel wall) rupture is a~     catastrophic disease, with half of the victims died and many of the survivors disabled. There~     is currently no data in the literature for the Chinese population concerning the prevalence,~     characteristics (location and size) and risk of harboring an unruptured intracranial~     aneurysm. In this study, the investigators aim to study the population prevalence and~     characteristics (location and size) of intracranial aneurysm in Hong Kong Chinese, and its~     cost-effectiveness. The screening is carried out using magnetic resonance angiography (MRA),~     with a 3-T magnetic resonance system, which is a well-established non-invasive method for~     intracranial aneurysm detection.~   "
189924|NCT01078493|"~     Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen~     commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host~     of growth factors, which have been used in other clinical trials for various medical~     conditions such as tendonitis, and also in surgery such as the surgical repair of facial~     defects. Results from these clinical trials suggest that PRP helps in collagen formation and~     organisation to promote healing of tissues. This study attempts to document the clinical~     effects of intradermal injection of PRP on wrinkles.~   "
189925|NCT01078480|"~     This study will compare non-operative treatment of displaced midshaft collarbone fractures~     with operative treatment using a precontoured titanium plate and screws.~      The study hypothesis is that operation will provide better pain relief, faster return to~     activities, better function of the involved upper limb, and lower the risk of a non healing~     fracture (non union).~   "
189926|NCT01078467|"~     Background:~        -  Two important properties distinguish the healing process of skin wounds from that of~          wounds of the mucous membranes of the mouth (oral mucosa). Although the skin and the~          oral mucosa tissues are similar in nature, oral mucosa have more rapid healing and a~          lack of scar tissue formation. However, oral wound healing in general has been poorly~          studied, and more information is needed to determine how specific aspects of the oral~          environment affect the healing process.~        -  Researchers are interested in identifying various factors that contribute to oral wound~          healing. Studying this process would help researchers explore procedures to accelerate~          the healing of critically-sized oral lesions formed by trauma, surgery, radiation~          therapy, infection, and other damage to the mouth. In addition, research into scar-free~          healing could be applied to other mucosal sites to promote healing and minimize~          unsightly scars that may compromise the tissue.~      Objectives:~      - To identify the specific factors that enable rapid and nearly scar-free healing of oral~     mucosa.~      Eligibility:~        -  Healthy male volunteers between 18 and 40 years of age.~        -  Regular cigarette, cigar, and pipe smokers; occasional smokers who smoke more than 1 day~          a week or have smoked in the prior month; users of chewing tobacco or betel nut; and~          heavy drinkers (three or more alcoholic drinks per day) will be excluded.~      Design:~        -  Participants will have a medical history and examination, and will provide blood samples~          at the start of the study.~        -  Participants will provide oral mucosa samples from the inside of the cheek, taken using~          a dermal punch. At the same time, participants will provide skin biopsy samples of~          approximately the same size. After the skin and oral mucosa samples are taken,~          participants will be divided into three groups for follow-up procedures.~        -  Group 1: No further samples will be collected. This group will help document the normal~          healing process.~        -  Group 2: A second, slightly larger biopsy, which will include the area of the first~          biopsy, will be taken on day 3. Both skin and oral mucosa biopsies will be taken.~        -  Group 3: A second, slightly larger biopsy will be taken on day 6, in a similar way as~          described for Group 2. Both skin and oral mucosa biopsies will be taken.~        -  Wounds will be photographed with a digital camera on days 3, 6, 9, 13, and 15; and the~          healing will be monitored at the scheduled clinic visits.~   "
189927|NCT01078454|"~     This randomized phase III trial is studying melphalan and dexamethasone to see how well they~     work with or without bortezomib in treating patients with previously untreated systemic~     amyloidosis. Drugs used in chemotherapy, such as melphalan and dexamethasone, work in~     different ways to stop the growth of plasma cells, either by killing the cells or by stopping~     them from dividing. Bortezomib may stop the growth of plasma cells by blocking some of the~     enzymes needed for cell growth. It is not yet known whether giving melphalan together with~     dexamethasone is more effective with or without bortezomib in treating systemic amyloidosis.~   "
189928|NCT01078441|"~     This phase II trial is studying how well giving bortezomib together with liposomal~     doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients~     with multiple myeloma that relapsed after autologous stem cell transplant. Bortezomib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as liposomal doxorubicin hydrochloride, dexamethasone, and~     cyclophosphamide, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving bortezomib together with~     liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide may kill more cancer~     cells.~   "
189929|NCT01078428|"~     Keloids and hypertrophic scars are a common subject of dermatologic consultations.~     Therapeutic management of such conditions remains challenging because of their high rate of~     recurrence and lack of curative treatment.~   "
189930|NCT01078415|"~     The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System~     for the treatment of early-stage hepatocellular carcinoma (HCC).~   "
189931|NCT01078402|"~     This is a non-interventional, post-marketing, observational study (PMOS) in which Humira~     (adalimumab) is prescribed in the usual manner in accordance with the terms of the local~     marketing authorization with regards to dose, population and indication. No data currently~     exists to characterize patient populations being prescribed Humira in Eastern Europe.~     Further, it is important to establish the clinical outcome and tolerability of Humira in~     Eastern European patients, as well as their compliance with Humira treatment, in particular~     the acceptability of self-injection, which may influence all of the above in routine clinical~     practice.~   "
189932|NCT01078389|"~     This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint~     damage in patients with elevated serum urate levels and gout.~   "
189934|NCT01078363|"~     Cardiac transplantation is the ultimate treatment option for patients with end stage heart~     failure.~      Cardiac allograft vasculopathy remains a leading cause of morbidity and mortality after~     transplantation.~      Angiotensin converting enzyme inhibitors are used in less than one half of transplant~     recipients. Preliminary data suggest that angiotensin converting enzyme inhibitors retard the~     atherosclerotic plaque development that is the hallmark of cardiac allograft vasculopathy.~     Moreover, this class of drug appears to increase circulating endothelial progenitor cell~     number and has anti-inflammatory properties, both of which improve endothelial dysfunction,~     the key precursor to the development of cardiac allograft vasculopathy.~      The objective of this project is to investigate the role of an angiotensin converting enzyme~     inhibitor, ramipril, in preventing the development of cardiac allograft vasculopathy. During~     the first month after cardiac transplantation subjects will undergo coronary angiography with~     intravascular ultrasound measurements of plaque volume in the left anterior descending~     coronary artery. Using a coronary pressure wire, epicardial artery and microvascular~     physiology will be assessed. Finally, endothelial function and mediators of endothelial~     function, including circulating endothelial progenitor cells, will be measured. Subjects will~     then be randomized in a double blind fashion to either ramipril or placebo. After 1 year, the~     above assessment will be repeated. The primary endpoint will be the development of cardiac~     allograft vasculopathy based on intravascular ultrasound-derived parameters. The second aim~     will be to assess the effect of ramipril on endothelial dysfunction early after~     transplantation. The final aim is to determine the impact of ramipril on coronary physiology~     early after transplantation.~   "
189935|NCT01078350|"~     This study is designed to collect tissue samples that may aid in the treatment and learning~     about various oncology diagnosis.~   "
189936|NCT01078337|"~     To determine if MRD (minimal residual disease) can be found in the blood (only) as opposed to~     bone marrow in children with ALL (acute lymphoblastic leukemia).~   "
189937|NCT01078324|"~     The purpose of this study is to study the demographic,laboratory,endoscopic, and outcomes of~     ischemic colitis patient presented with severe lower gastrointestinal bleeding compared to~     other diagnoses.~   "
189938|NCT01078311|"~     Sorafenib improves overall survival and progression free survival in advanced hepatocellular~     carcinoma. Wide interindividual pharmacokinetic variability was observed. Data from early~     phase trials in solid tumours showed trough sorafenib levels were associated with incidence~     of skin rash and hypertension. Rash, hypertension and higher trough levels were moderately~     predictive of progression free survival.The trough level of sorafenib may be predictive of~     survival and response in patients treated with sorafenib for advanced hepatocellular~     carcinoma.~   "
189939|NCT01078298|"~     Patients with depression tend to have a higher prevalence of smoking as well as increased~     severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that~     demonstrated its efficacy and tolerability have not included subjects with depression. This~     smoking cessation study focuses on the depressed population and will assess the efficacy and~     safety of varenicline.~   "
189940|NCT01078285|"~     Despite extensive reports of the benefits of statins in reducing serious cardiovascular~     events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients~     do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of~     understanding of the seriousness of the disease, and fear of side effects. An intervention~     strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be~     motivational and improve adherence to treatment.~   "
189941|NCT01078272|"~     This study tests the hypothesis that repeated inflation of a blood pressure cuff on the arm~     will improve results of coronary stent implantation by:~        -  reducing chest pain and electrocardiogram changes during balloon inflation to place the~          stent~        -  reducing leakage of heart muscle protein(troponin) into the blood stream after stent~          placement, indicated reduced damage to heart muscle during stent implantation~        -  increases in molecules in the blood that promote dilation of arteries~        -  reduced evidence of heart muscle damage on MRI immediately after stenting~        -  improved patient outcomes over six months with fewer adverse cardiovascular events(heart~          attack, acute coronary syndrome,renarrowing of the stented artery, heart failure, death,~          stroke, transient ischemic attack)~        -  improved heart structure and function at 6 months after stenting~   "
189942|NCT01078246|"~     The objective of this study is to monitor Health Outcomes of Interest (HOI) in participants~     with human immunodeficiency virus-1 (HIV-1) infection following treatment with Raltegravir.~   "
189943|NCT01078233|"~     The main objective of the study is to monitor health outcomes associated with antiretroviral~     drugs in a population of HIV-infected patients.~   "
189944|NCT01078220|"~     This is a post-licensure safety surveillance program to detect potential safety signals in~     subjects, from the managed care organizations database, who have used GARDASIL™.~   "
189945|NCT01078207|"~     This study will include patients who have major surgery and are at risk for or have been~     diagnosed with sleep apnea. The patients will be monitored the night after surgery for~     repeating episodes of reduced breathing and oxygen levels. The study will determine if~     episodes of decreased breathing are reflected in the oxygen monitor.~   "
189946|NCT01078194|"~     This is an observational study on the efficacy of the secondary placement of the A.M.I Soft~     Gastric Band in weight regain or weight loss failure after lap. gastric bypass.~   "
189947|NCT01078181|"~     This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux~     in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass~     Band (B-Band.~   "
189948|NCT01078168|"~     The trials investigates the changes of cerebral spinal fluid (CSF) soluble alpha-secretase~     cleaved APP (APPsα) levels under oral therapy with acitretin 30mg daily in patients with mild~     to moderate Alzheimer's disease (AD).The present study aims to demonstrate an enhancement of~     the α-secretase activity by acitretin as measured by increased CSF APPSα levels in human AD.~     Second, the safety and tolerability of acitretin in AD patients should be proven.~   "
189976|NCT01077804|"~     The purpose of these continuing post-licensure studies is to evaluate the long-term~     effectiveness of VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)] and to assess the impact~     of the vaccine on the epidemiology of varicella and herpes zoster.~   "
189949|NCT01078155|"~     This post marketing observational study will be conducted in a prospective, single country,~     multicenter format to assess the prevention of generalized bone loss in patients with active~     rheumatoid arthritis (RA) treated with adalimumab (Humira®) in pragmatic prescribing~     situations. The investigational sites will be centers with experience in the treatment of RA~     patients and anti-tumor necrosis factor-alpha (TNF-a) therapy. The investigators will be~     rheumatologists authorized by the Czech Rheumatologic Society for prescribing biological~     treatment.~   "
189950|NCT01078142|"~     This is a multicenter, open label, single arm, phase I/II study. There will be no placebo~     usage within this trial.~      Phase I:~      Primary: To establish a maximum tolerated dose of the addition of Temsirolimus to a regimen~     of Bendamustine and Rituximab (BERT) in patients with relapsed follicular lymphoma and mantle~     cell lymphoma.~      Phase II:~      Primary: To evaluate the ORR in patients with MCL or FL treated with the established BERT~     dose Secondary: To determine the complete remission rate, progression free survival rate and~     overall survival rate and to investigate safety and tolerability of BERT.~   "
189951|NCT01078129|"~     Objectives:~      The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy~     (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with~     schizophrenia.~   "
189952|NCT01078116|"~     Evaluation of Health Related Quality of Life (HRQL) is of a paramount importance in assessing~     the impact of rheumatoid arthritis on patients' health status, however when costs associated~     with rheumatoid arthritis are also taken into account, the information provided may lead to a~     more balanced view in analyzing the treatment of the disease.~      In accordance with the above, the main objective this study was to evaluate the impact of~     adalimumab treatment not only on patients' Health Related Quality of Life but also on the~     cost of the disease management. In order to accomplish this the study has been focused on:~        1. Estimating the direct and indirect cost incurred by adalimumab treatment.~        2. Measuring the Health Related Quality of Life of rheumatoid arthritis patients under~          adalimumab treatment.~        3. Exploring the cost-utility relationship of rheumatoid arthritis patients treated with~          adalimumab by combining the Health Related Quality of Life of rheumatoid arthritis~          patients and direct as well as indirect costs due to RA.~      More specifically, data related to patients' Health Related Quality of Life and cost~     associated with rheumatoid arthritis will be recorded for one-year period, and collected at~     four subsequent visits: baseline, month 3, 6 and 12. The visit before starting treatment with~     adalimumab will be considered as baseline. This information was used to compare Health~     Related Quality of Life and cost data before and after adalimumab initiation and therefore~     identify the effect of adalimumab treatment in patients with rheumatoid arthritis.~   "
189953|NCT01078103|"~     Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and~     may be at risk in any intraocular surgical procedure, while others showed no significant~     differences between diabetic and non-diabetic corneal endothelium.The purpose of this study~     is to investigate the differences in corneal endothelial cell density and morphology in~     diabetic patients and normal patients after phacoemulsification with intraocular lens~     implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal~     endothelial cell changes after phacoemulsification.~   "
189954|NCT01078090|"~     Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a~     large patient collective under everyday clinical conditions over a 5-year period.~   "
189955|NCT01078077|"~     The purpose of this study is to determine if a topical vasodilating cream will improve female~     sexual experience.~   "
189956|NCT01078064|"~     Gastroesophageal reflux events generally happen during relaxation of lower esophageal~     sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The~     investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead~     to reflux events. To test this hypothesis, a study was designed to measure the gastric~     accommodation in patients undergoing esophageal impedance monitoring.~   "
189957|NCT01078051|"~     The purpose of this study is to compare the safety and effectiveness of drug-eluting stent~     implantation compared to optimal medical treatment in patients with chronic total occlusion.~   "
189958|NCT01078038|"~     This randomized study is a multi-center, randomized, study to compare the efficacy of~     sirolimus versus everolimus-eluting stent implantation for long coronary lesions.~   "
189959|NCT01078025|"~     Transvaginal hybrid procedures are of interest as an available NOTES procedure for the~     clinical routine. The gynaecologists` experiences and the available studies report on low~     morbidity related to the transvaginal access. However, little is known about the vaginal and~     intraabdominal microbial contamination due to the transvaginal approach.~      The aim of this cohort study is to evaluate the microbial colonisation and contamination in~     patients with transvaginal hybrid and conventional laparoscopic cholecystectomy.~      Therefore, pre- and intraoperative microbiological evaluations will be performed in patients~     with transvaginal hybrid cholecystectomy and laparoscopic cholecystectomy.~   "
189960|NCT01078012|"~     The purpose of the study is together with the BIMOH (NCT01314768) RCT study to evaluate~     whether training of GPs in the detection and treatment of medication overuse headache leads~     to improved care for these patients as compared to business as usual.~   "
189961|NCT01077999|"~     A consistent finding in many studies in patients with operable esophageal and~     gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy,~     particularly the absence of residual disease in the surgical specimen, is an indicator of~     better disease-free and overall survival. Therefore in the investigators trial the~     investigators will evaluate the pathologic response of panitumumab in combination with~     neoadjuvant chemoradiation as first line treatment of operable adenocarcinomas,~     undifferentiated or squamous cell carcinomas of the esophagus.~   "
189962|NCT01077986|"~     In this study the investigators want to determine the activity and safety of concurrent~     interruption of the MAPK and PI3K pathways by EGFR and mTOR inhibition in patients with~     metastatic pancreatic cancer.~   "
189963|NCT01077973|"~     This study will compare the ability of a single-dose of a novel ibuprofen formulation to~     relieve pain compared to placebo and standard ibuprofen in the treatment of episodic~     tension-type headache.~   "
190396|NCT01072318|"~     The purpose of this study is to assess Efficacy and Safety of Extended Adjuvant Treatment~     With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who~     Complete 5 Years of Toremifene~   "
189964|NCT01077960|"~     In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly~     assigned in a 3.0-to-1.0 ratio to Groups A and B. All patients in Group A received~     recombinant human growth hormone (Serostim®) 4 mg daily (the induction phase) for the first~     12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on alternate~     days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the maintenance phase). All~     patients in Group B initially received placebo from baseline to Week 24, and then received~     Serostim® 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007).~      In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was~     assigned to Group A, who fully completed all study visits without a major protocol violation,~     was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg daily for 12~     weeks. During study 25373, safety was monitored by recording of adverse events and~     measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting~     insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of~     study termination, subjects underwent re-assessment of body composition via anthropometry~     measurements and dual photon absorptiometry (DXA) scanning. In addition, at study~     termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth~     binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were~     obtained.~   "
189965|NCT01077947|"~     Although discography and spinal imaging techniques, either alone or in combination, are~     commonly used to diagnose discogenic pain, their exact role in predicting surgical results~     are poorly defined. Our aim in this study is to compare the ability of Functional anesthetic~     discography (FAD), and Provocative Discography (PD) to diagnose discogenic pain and to~     correctly identify the disc levels for the surgical treatment. Proper identification for disc~     levels should improve the overall results of surgery for this condition. Patients with~     discogenic pain have better outcomes if the disc levels for the fusion surgery are identified~     by using FAD compared to similar disc level identification by PD.~   "
189966|NCT01077934|"~     The purpose of this study is to define the reliability and accuracy of Near Infrared~     Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and~     noninjured extremities over time. We hypothesize that this technology, combined with vital~     signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing~     acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the~     adequacy of fasciotomy in patients treated for ACS.~   "
189967|NCT01077921|"~     An open label, prospective, randomized cross-over phase II study in up to 60 sickle cell~     patients who are either homozygous for Hb S or have HbSB0 thalassemia. Initially, each~     patient will be treated for 6 weeks with placebo or a standard dose of propranolol (40 mg)~     every 12 hrs. This will be followed by a 2-week washout period after which, patients will~     receive the other treatment modality (placebo or propranolol).~      We Hypothesize that propranolol administered in vivo on a daily basis for 6 weeks (1) will~     decrease baseline adhesion to endothelial cells and will substantially abrogate~     epinephrine-stimulated adhesion to endothelial cells, as measured in vitro; (2) will improve~     biomarkers of endothelial activation and dysfunction; and (3) can be safely used in patients~     with SCD. Thus, the use of propranolol in SCD may represent a safe and effective means of~     anti-adhesive therapy in SCD.~      Study Objectives:~      Primary Objective:~      • To establish the safety and efficacy of long-term therapy with propranolol as an~     anti-adhesive therapy for SCD.~      Secondary Objective:~      • To evaluate changes in soluble markers of endothelial activation and dysfunction.~      Correlative Science Objective:~      • To determine whether response to propranolol therapy is associated with polymorphisms in~     genes encoding the proteins involved in the upregulation of Sickle Red Blood Cell (SS RBC)~     adhesion by epinephrine.~   "
189968|NCT01077908|"~     The purpose of this study is to evaluate the potential clinical benefit of prophylactic~     cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic~     hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.~   "
189969|NCT01077895|"~     Intra- abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) are a cause of~     organ dysfunction in critically ill patients. IAH develops due to abdominal lesions (primary~     IAH) or extra-abdominal processes (secondary IAH). Secondary IAH arises due to decreased~     abdominal wall compliance and gut edema caused by capillary leak and excessive fluid~     resuscitation. Decreasing intra-abdominal pressure (IAP) using decompressieve laparotomy has~     been shown to improve organ dysfunction. However, laparotomy is generally avoided in patients~     with secondary IAH due to the risk of abdominal complications.~      Acute kidney injury (AKI) is one of the first and most pronounced organ failures associated~     with IAH and many patients with AKI in the ICU require renal replacement therapy (RRT). Fluid~     removal using continuous RRT (CRRT) has been demonstrated to decrease IAP in small series and~     selected patients.~      The aim of this study is to evaluate whether fluid removal using CVVH in patients with IAH,~     fluid overload and AKI is feasible and whether it has a beneficial effect on organ~     dysfunction (compared to CVVH without net fluid removal).~   "
189970|NCT01077882|"~     'OnderHUIDs' is an educational program (Department of Dermatology, University Hospital, Gent)~     for patients with psoriasis and atopic dermatitis. We want to stimulate the patient to~     actively participate in their therapeutic approach by enhanced self care. We call the~     hypothesis that this program will help the patients learn to cope with their disease and to~     be loyal to their treatment, which will result in a better quality of life, better clinical~     outcome and cost effectiveness.~   "
189971|NCT01077869|"~     In this study, the feasibility of optical imaging and FDG-PET in the evaluation of~     radiation-induced mucositis will be evaluated.~   "
189972|NCT01077856|"~     This study will assess the impact of GARDASIL™ human papillomavirus (HPV) vaccine in the~     general female population by utilizing nationwide registry databases in the participating~     Nordic countries.~   "
189973|NCT01077843|"~     This study is a population-based cohort of patients with ankylosing spondylitis (AS) from~     general medical practices in the UK, France, and Germany with a nested case control component~     to assess associations between drug exposures of interest and clinical outcomes relevant to~     patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs~     (NSAIDS).~      The main objective of the study is to describe in European participants with AS: 1) the use~     of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of~     etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes~     of interest relative to non-use of these medications and relative to each other.~   "
189977|NCT01077791|"~     Theory of mind (ability to infer others' intention, emotion, etc) is known to be altered in~     patients with schizophrenia and its deficit to be correlated with their decreased social~     proficiency. We designed a novel cognitive therapy, that makes use of videos, aimed at~     learning a better use of contextual information to infer others' intentions. The aim of this~     study is to demonstrate, in schizophrenic patients, a quantitative improvement of their~     ability to infer intention of others induced by this novel training program. A secondary aim~     is to measure the cerebral correlates (MEG, PeV) of this social cognitive function and of its~     anticipated improvement.~   "
189978|NCT01077778|"~     -  The purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic~          resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in~          patients with clinically suspected acute pulmonary embolism~        -  Thoracic CT angiography (CTA) will serve as reference standard~        -  Result of MRI will not interfere with patients' management~        -  Untreated patients with negative CTA will have 3-month follow-up to verify they were~          free of thrombose-embolic disease~   "
189979|NCT01077765|"~     Combined antiretroviral therapy (cART) is associated with facial lipoatrophy, which is~     potentially stigmatizing for HIV-positive patients. Eutrophill is a 2.5% polyacrylamide~     hydrogel obtained by polymerization of acrylamide monomers with an official half-life of 5~     years.~      Preliminary encouraging results with the use of polyacrylamide hydrogel for reconstruction of~     facial lipoatrophy in HIV-infected patients have been previously reported.~      The primary objective of the study was to evaluate the long-term efficacy and safety of~     subcutaneous facial injections of Eutrophill in HIV-infected patients with severe facial~     lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months~   "
189980|NCT01077752|"~     In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area~     around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed~     in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 :~     intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All~     patients will receive parenteral analgesia combining acetaminophen and morphine.~   "
189981|NCT01077739|"~     This open-label single arm study will evaluate the efficacy and safety of Avastin added to~     XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st~     line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv~     infusion every 3 weeks) and standard XELOX (Xeloda [capecitabine] plus oxaliplatin)~     chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and~     leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until~     disease progression, and the target sample size is 100 individuals.~   "
189982|NCT01077726|"~     This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases~     in breast cancer patients with central nervous system (CNS) progression after whole brain~     radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week~     cycle. The anticipated time on study treatment is until disease progression, and the target~     sample size is <100 individuals.~   "
189983|NCT01077713|"~     This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin~     + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients~     with non-squamous non-small cell lung cancer. Patients will be randomised to receive either~     Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or~     Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8~     of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to~     receive Avastin monotherapy. The anticipated time on study treatment is until disease~     progression, and the target sample size is <100 individuals.~   "
189984|NCT01077700|"~     This is an efficacy and safety study evaluating an experimental treatment for cognitive~     deficits in adults with schizophrenia.~   "
189985|NCT01077687|"~     This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications~     that propose to enrich pre-existing resources for schizophrenia in the NIMH Human Genetics~     Initiative and to apply genomic methods to further our understanding of the molecular~     etiology of the disorder. The overarching aims of this proposal are to quickly and~     cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to~     discover causal variants for the disorder in the first family-based genome-wide association~     study (GWAS) of the disorder. In Taiwan, there is no such kind of policy to support this kind~     of GWAS study as it is a very expensive study, including collecting large family samples and~     genome-wide SNP scanning. We, thus, collaborate with Professor Ming T, Tsuang and his~     extended subcontracted researchers to apply for this project. We, the research team in~     Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia. In our recently~     completed NIMH-funded Genetic Linkage Study of Schizophrenia (R01MH059624; USA PI: Ming T.~     Tsuang; Taiwan PI: Hai-Gwo Hwu), the investigators established a large and efficient~     ascertainment network and infrastructure in Taiwan, which will again be utilized and expanded~     in the proposed study. Through additional ascertainment within this framework, the~     investigators will collect an aggregate sample with adequate power for detecting in a GWAS~     those variants that make even small contributions to the risk for the disorder.~      The investigators will meet the overarching goals of this project by accomplishing several~     Specific Aims, as follows:~        1. Rapidly ascertain schizophrenia trio families from ten Taiwanese clinical ascertainment~          sites;~        2. Supplement NIMH Genetics Initiative collections by sending all clinical data and~          biomaterials to the appropriate repositories;~        3. Assess the association of schizophrenia with a genome-wide panel of single-nucleotide~          polymorphisms (SNPs) and their constituent haplotypes;~        4. Analyze quantitative schizophrenia phenotypes such as age at onset ;~        5. Perform a genome-wide survey for copy-number variations related to schizophrenia;~        6. Test for gene-gene interactions (epistasis); and~        7. Test for gene-environment interactions, such as the well-established effect of season of~          birth.~   "
189986|NCT01077674|"~     Bispectral Index (BIS) and Entropy indices will be compared with each other, and to raw EEG~     signals in patients receiving sevoflurane anaesthesia. BIS and Entropy numbers often differ~     significantly from each other during surgery, and the reason for this has not been studied in~     detail, therefore remaining only poorly understood. BIS and Entropy, together with~     multi-channel EEG, will be collected and analyzed later on. Course of anaesthesia and surgery~     will be annotated. All relevant information from anaesthesia monitor will be collected on~     computer.~   "
189987|NCT01077661|"~     An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor~     the safety and effectiveness of Nebivolol administered in Korean patients according to the~     prescribing information~   "
189988|NCT01077648|"~     The purpose of this epidemiologic study is to establish a population-based cohort of women~     with advanced stage breast cancer which can be used to quantify the frequency and timing of~     brain metastases, and other distant metastases, in this patient population.~   "
196272|NCT00994292|"~     The purpose of this study is to evaluate the safety and efficacy of various doses of YM150~     (the experimental drug) in the prevention of ischemic vascular events in subjects with recent~     acute coronary syndromes.~   "
189989|NCT01077635|"~     Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated~     for the treatment of HIV-infected adults, adolescents and children of 6 years of age and~     above for use in combination with other anti-HIV medicines. Safety data from two~     GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or~     without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated~     that gastrointestinal events were the most commonly reported AEs, but that the majority of~     events were mild and of short duration. Treatment emergent grade 3 / 4 neutropenia was~     reported in 20% of children in the APV20003 trial; and neutropenia was identified as a~     potential safety concern by the European Medicines Agency (EMEA). The objectives of this~     study were to conduct an observational cohort study of the usage and safety of FPV/RTV in~     children and adolescents (aged 6 ≤ 18 years) with HIV infection in several European HIV~     paediatric cohorts. Data will be collected for 3 years (2008, 2009 and 2010).~   "
189990|NCT01077622|"~     Ofatumumab is an IgG1κ fully human monoclonal antibody (mAb) that specifically recognizes an~     epitope on the human differentiation antigen CD20 molecule. In vitro and in vivo studies~     demonstrated that ofatumumab depletes CD20 positive (CD20+) B cells through~     complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity~     (ADCC), which results in the antitumour effect.~      This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of~     ofatumumab monotherapy in chronic lymphocytic leukemia (CLL) patients. Ofatumumab will be~     administered intravenously at the first dose of 300mg followed by 7 weekly infusions of~     2000mg, followed by 4 infusions of 2000mg at every 4 weeks.~      Primary objective of the study (Part A) is to evaluate tolerability, and the study (Part B)~     is to assess overall response rate in CLL population.~      10 subjects will be enrolled into this study. Subjects will be followed for 48 weeks.~   "
189991|NCT01077609|"~     This is an inception cohort study that analyses data from an administrative medical records~     database. The two inception cohorts are: 1) patients initiated on intranasal FP and 2)~     patients initiated on another INS (not FP). The candidates for the inception cohorts did not~     use any intranasal steroid in the year prior to initiation.~   "
189992|NCT01077596|"~     There is a lack of toxicology data on one bupropion metabolite, and limited literature~     examining bupropion use and cancer risk. This study evaluates the association between~     bupropion exposure and the development of cancer of the prostate, breast, lung, colon/rectum,~     urinary bladder, and uterus by comparing the risk of cancer in bupropion users with other~     antidepressant users. Because there is no evidence that bupropion is associated with any~     particular cancer, we have chosen the six most common cancers diagnosed in the United States~     to optimize statistical power/precision for cancer-site specific comparisons. Two US~     population-based data resources with automated claims, pharmacy, and tumor registry data are~     included in this study. Using a nested case-control design, this study will compare the~     incidence of cancer in patients exposed to bupropion with the incidence in patients exposed~     to other antidepressants.~   "
189993|NCT01077583|"~     The purpose of this study is to collect urine samples and dating scan information from women~     who wish to become pregnant. Urine samples will be tested in the laboratory with the~     Clearblue Pregnancy Test and the results correlated with volunteer information.~   "
189994|NCT01077570|"~     This study is conducted in Asia. The aim of this observational study is, under normal~     clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese~     patients with type 2 diabetes who have never received anti-diabetic treatment before.~   "
189995|NCT01077557|"~     This US population-based study will explore the incidence of and risks for fracture among~     adults with and without human immunodeficiency virus (HIV) infection. The objectives are to~     determine the incidence of fracture among persons with and without HIV infection, compare~     risk factors for fracture among persons with and without HIV infection, and to examine the~     associations of antiretroviral (ARV) treatment exposure for incidence and risk of fracture~     among persons with HIV infection.~   "
189996|NCT01077544|"~     This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that~     are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or~     relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity~     of nilotinib as secondary objectives.~   "
189997|NCT01077531|"~     The assessment of otelixizumab in rheumatoid arthritis subjects will provide safety,~     tolerability, pharmacodynamic and pharmacokinetic information which will enable the~     identification of appropriate safe and well-tolerated dosage regimens to be used in clinical~     efficacy studies. This study will consist of a screening phase, followed by a treatment~     period where four cohorts of subjects will receive 5 daily intravenous infusions of~     otelixizumab. The cumulative dose will increase in each successive cohort and infusion rates~     can be adjusted based on signs and symptoms of cytokine release syndrome and to ensure the~     specified maximum infusion rate is not exceeded. Serial blood samples will be obtained for~     clinical laboratory testing, determination of pharmacodynamic markers, serum otelixizumab PK~     parameters, exploratory biomarkers and immunogenicity. Safety and pharmacodynamic data from~     the previous cohort(s) will be evaluated prior to dosing subsequent cohorts to ensure safety.~     Adverse events, laboratory values, vital signs and ECG's will be monitored closely during~     this study. All subjects in the study will undergo long-term follow-up out to 48 months to~     monitor patient safety.~   "
189998|NCT01077518|"~     The purpose of this study is to evaluate the safety and efficacy of ofatumumab and~     bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to~     rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab~     treatment.~   "
189999|NCT01077505|"~     This study will be an open-label study to evaluate the effect of albiglutide on the~     pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon).~     The primary objective of this study is to demonstrate the lack of effect of albiglutide doses~     on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female subjects.~   "
190000|NCT01077492|"~     The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided~     transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes~     which is needed for correct staging of lung cancer.~   "
190001|NCT01077479|"~     The main purpose of this study is to assess the efficacy of metformin in abrogating androgen~     deprivation therapy (ADT) induced insulin resistance as measured by homeostasis model~     assessment (HOMAIR) in men with non-metastatic prostate cancer.~   "
190003|NCT01077453|"~     This randomized phase I trial studies the side effects and the best dose of letrozole in~     preventing breast cancer in healthy postmenopausal women at high risk for breast cancer.~     Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The~     use of letrozole may keep cancer from forming in healthy postmenopausal women at high risk~     for breast cancer.~   "
190004|NCT01077440|"~     RATIONALE: Studying samples of semen from cancer survivors in the laboratory may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This phase I research study is looking at the presence of donor-derived DNA in semen~     samples form cancer survivors who underwent donor stem cell transplant.~   "
190005|NCT01077427|"~     Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through~     an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia~     as compared to standard chemotherapy.~   "
190006|NCT01077414|"~     Background:~        -  A person s mental state, personal relationships, or spiritual well-being often change in~          many ways during or after cancer. Some of these changes can have a life-changing~          positive side, called psycho-socio-spiritual or PSS Healing. For example, a person may~          feel mentally stronger or more whole than before their cancer.~        -  Because researchers are interested in enhancing such experiences in other cancer~          patients, there is interest in developing a way to measure PSS Healing that would be~          helpful in understanding this phenomenon.~      Objective:~      - To determine and categorize the characteristics of PSS Healing, which could lead to~     development of a psychometric instrument to measure it.~      Eligibility:~      - Adults who have cancer or have had cancer that was diagnosed after the age of 18 and who~     have had at least one strong positive emotional or mental change in relation to the cancer~     (e.g., relationships with others, spiritual well-being or faith, thoughts about the meaning~     of life, reactions to stress).~      Design:~        -  The study design does not involve any treatment or counseling.~        -  Participants will be interviewed by a research team member. The one-time interview will~          last up to 2.25 hours and will be audiotaped and transcribed.~        -  Interviews will consist of an in-depth portion to assess the positive changes in~          relation to the illness. Participants will then be asked to identify from a list of~          short descriptions the ones that best reflect their personal experience of PSS Healing.~        -  Transcribed information will be coded and categorized according to standard research~          techniques.~   "
190007|NCT01077401|"~     The purpose of this study is to investigate the safety, tolerability, bioactivity, and dose~     response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with~     diabetic macular edema (DME).~   "
190008|NCT01077388|"~     The e-Care for Heart Wellness study will look at ways to reduce a person's chances of getting~     heart disease. We are asking about 100 Group Health members whose electronic medical record~     shows they have uncontrolled high blood pressure to be in the study. Having high blood~     pressure increases your future risk of heart attacks and strokes.~      There are many things you can do to help keep your heart healthy. Examples include lowering~     blood pressure and cholesterol, eating healthier, and being more active. Our goal is to test~     whether getting care and supportive emails from a dietician helps people do things like this~     to lower their chances of having a heart attack or a stroke.~      For some people, this study will involve both research and clinical care. About half the~     people in the study will receive care related to heart disease prevention from a dietician.~     It's a standard clinical practice for dieticians to help people reduce their risk of heart~     attacks and strokes. What's different about this study is using emails from a dietician to~     help people take steps to improve their heart health.~   "
190009|NCT01077375|"~     The objective of this study is to evaluate the safety, tolerability and efficacy of~     milnacipran in patients with an inadequate response to duloxetine for the treatment of~     fibromyalgia.~   "
190010|NCT01077362|"~     The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and~     safety of ustekinumab in patients with psoriatic arthritis.~   "
190011|NCT01077349|"~     This study seeks to determine if early continuous High Volume Veno-venous Hemofiltration~     (HVHF) reduces 30-day all cause mortality in post-cardiac surgery patients developing shock~     requiring high doses catecholamines.~   "
190012|NCT01077336|"~     Susceptibility testing is commonly employed in patients with bacterial infections in order to~     guide rational use of antibiotics; however, the use of antifungal susceptibility testing is~     limited due to lack of availability, costs, and delays in receiving results. The goals of~     antifungal susceptibility testing should mirror those of antibacterial susceptibility~     testing: to predict clinical response or failure. Additionally, susceptibility reports should~     be used as a guide for physicians when transitioning patients from parenteral to oral~     antifungal agents. Currently, it is unknown whether antifungal susceptibility testing impacts~     treatment decisions in hospitals that routinely perform Candida susceptibility testing. The~     purpose of this study is to evaluate the changes in antifungal treatment based on in vitro~     susceptibility reports and how these decisions affect mortality, recurrence of infection, and~     length of hospital stay in candidemia patients.~   "
190013|NCT01077323|"~     The purpose of this research was to assess the absolute and relative incidence of acute~     pancreatitis in persons initiating exenatide compared with persons initiating a different~     antidiabetic agent, and secondarily, persons without diabetes. This protocol summarizes a~     retrospective cohort study using eligibility, pharmacy claims, and medical claims data from a~     large US health plan affiliated with i3 Drug Safety.~   "
190014|NCT01077310|"~     This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus~     intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual~     of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem~     drinking, who are transitioning to the community and seeking treatment to prevent relapse to~     alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved~     HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol~     treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of~     reincarceration.~   "
190015|NCT01077297|"~     Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the~     Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With~     Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin~     Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines~   "
190017|NCT01077271|"~     Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against~     respiratory syncytial virus (RSV) infection as shown in the IMpact study. Many factors such~     as parents' knowledge of burden of respiratory syncytial virus disease or physicians'~     satisfaction with Synagis as well as the appropriate use of the product might influence~     compliance. The primary objective of this observational study is to evaluate the compliance~     to Synagis under daily pediatricians practice conditions in premature infants 33 to 35 weeks~     gestational age (wGA). Palivizumab, monoclonal antibody for passive immunoprophylaxis against~     severe respiratory syncytial virus disease, was administered according to usual clinical~     practice. Compliance was assessed using four criteria: The number of injections per~     participant per respiratory syncytial virus season, the body site where injections were~     administered, the interval in days between injections, and the dosage per administration.~     Originally the study was to include two respiratory syncytial virus seasons but was extended~     to a third season.~   "
190018|NCT01077258|"~     Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a~     large patient collective under everyday clinical conditions over 2 years.~   "
190019|NCT01077245|"~     Patients with confirmed C. difficile infection (CDI) who meet eligibility requirements will~     be invited to participate. All study patients must receive treatment for CDI with~     metronidazole or vancomycin. Enrolled patients will be randomized in a 1:1 ratio to receive~     MIYA-BM Fines Granules [Clostridium butyricum MIYAIRI 588 Strain (CBM588)] or a placebo~     orally twice a day for 42 days. Patients will be evaluated for safety and clinical outcomes~     through Day 180. Occurrence of adverse events (AEs), diarrhea history, and concomitant~     medications will be evaluated at scheduled study visits and telephone contacts.~   "
190020|NCT01077232|"~     Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical~     Practice.~   "
190021|NCT01077219|"~     This study purpose is (1) to develop the new energy expenditure equation; (2) to increase~     accuracy of energy cost prediction of cycle ergometer; (3) to find out some dependent~     factors.~   "
190022|NCT01077206|"~     Experimental evidences supported the benefit of Simvastatin in subarachnoid haemorrhage.~     Moreover, Simvastatin is a potent agent in achieving low-density lipoprotein (LDL) reduction~     with a proven safety profile. However, there is no clinical data to compare the efficacy of~     different dosage regimens (namely whether high-dose regimen is better) and related~     cost-effectiveness analysis, although biochemical actions and related neuroprotective~     mechanisms were thought to be dosage-related. This gap in knowledge is important, on how to~     implement the use of statin and interpret different trial results. With these in mind, the~     investigators designed the current study.~      Hypothesis:~      Daily Simvastatin 80mg (high dose) treatment given within 96 hours of the ictus over three~     weeks will reduce incidence and duration of delayed ischemic deficits following subarachnoid~     haemorrhage when compared to daily Simvastatin 40mg (normal dose) treatment, leading to~     improvement in clinical outcome, which translates into advantage in terms of~     cost-effectiveness.~   "
190023|NCT01077193|"~     Up to 45 men and women who meet the entry criteria will undergo the gastric plication~     procedure. The study will assess subject excess weight loss (%EWL) following the study~     procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.~   "
190024|NCT01077180|"~     The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol~     parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are~     refractory to full drug therapy.~   "
190025|NCT01077167|"~     The purpose of this trial is to obtain a pharmacokinetic profile (i.e. amount of drug in the~     blood over time) of Omecamtiv mecarbil in patients with stable heart failure.~   "
190026|NCT01077154|"~     Rationale: For women with early-stage breast cancer, bone is a frequent site of relapse, and~     most women with advanced breast cancer will eventually develop disease in the bone.~      Denosumab, a fully human monoclonal antibody that specifically inhibits RANK ligand, may have~     the potential to interrupt the hypothetical vicious cycle of cancer-induced bone~     destruction and tumor cell expansion through the bone. It is not yet known if denosumab may~     prevent disease recurrence in the bone or in any other part of the body.~      Purpose: This randomized phase 3 trial is studying the effect of denosumab to see if it can~     prevent disease recurrence in the bone or in any other part of the body, when it is given as~     adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease~     recurrence.~   "
190027|NCT01077128|"~     Primary objective~        -  To evaluate the quality of life of Adalimumab treated patients over a period of 12~          months~      Secondary objectives~        -  To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe~          chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical~          practice and in accordance with the terms of the European marketing authorization.~        -  To evaluate changes in patients quality of life according to treatment response over a~          12-month period~        -  To observe and assess the long term use and safety of Adalimumab as prescribed by the~          dermatologist in a normal clinical setting and in accordance with the terms of the~          European marketing authorization.~   "
190028|NCT01077115|"~     The aim of this work is to evaluate which of the two types of operation (traditional/open and~     laparoscopic) has more impact on patients who were operated electively due to their chronic~     calculous cholecystitis.~   "
190029|NCT01077102|"~     The main purpose of this project is to establish the additional value of eccentric versus~     concentric exercise to optimize muscle function in patients with severe COPD. With this pilot~     project the investigators expect that an eccentric endurance training protocol adapted to~     severe COPD patients will lead to gains in muscle strength, the primary outcome, and cellular~     adaptation (muscle morphology and oxidative capacity, mitochondrial respiratory capacity)~     when compared to a concentric training approach.~      This information will be essential if the investigators want to design and power a randomized~     clinical trial that will allow assessing effectiveness of this novel rehabilitation approach.~   "
190030|NCT01077089|"~     Hospitalized patients are often moved from their rooms to other hospital locations,~     particularly imaging facilities. For patients with traumatic brain injury, such movements may~     raise the risk of secondary brain injuries. The purpose of this study is to monitor brain~     injured patients during transport and to measure the resulting changes in intracranial~     pressure. This will allow for documentation of the frequency of secondary injury and help in~     understanding their causes.~   "
190031|NCT01077076|"~     This randomized, crossover study is to evaluate the early effectiveness, defined as effect on~     intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter~     (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional~     purposes are to:~        1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the~          1st, 4th, and 11th days of dosing with each of the indicated treatments;~        2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for~          controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.~        3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4~          hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid~          inhibition at steady-state when administered on the 11th day of dosing.~   "
190032|NCT01077063|"~     The purpose of this study is to assess in a controlled prospective setting, the safety of the~     use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant~     ascites.~   "
190033|NCT01077050|"~     The purpose of this clinical investigation was to determine the safety and effectiveness of~     the SciBase III device (Test) designed to help distinguish between malignant melanoma and~     benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological~     gold standard (Reference).~      The purpose of the study is to collect data to support a Pre-market Application(PMA) to~     obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical~     Impedance Spectrometer.~   "
190034|NCT01077037|"~     We are doing a study to assess the impact of including patients in making decision regarding~     their own medical care in the emergency department. We will randomly assign them to either~     receive a decision aid or usual care. In doing this, we aim to increase patient satisfaction~     and safely decrease medical cost.~   "
190035|NCT01077024|"~     The primary objective of this study is to evaluate the impact of substance-abuse treatment as~     usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as~     usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether~     concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use~     outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or~     methamphetamine dependence.~   "
190036|NCT01077011|"~     The purpose of this study is to compare the comfort and blurriness of an investigational~     lubricant eye drop with a marketed lubricant eye gel.~   "
190037|NCT01076998|"~     The purpose of this study is to compare the comfort and blurriness of the investigational~     lubricant eye drop with a marketed artificial tear ointment.~   "
190038|NCT01076985|"~     This non-interventional, post-marketing observational study was conducted to obtain safety~     data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women~     and their children in Japan.~   "
190039|NCT01076972|"~     This non-interventional, post-marketing observational study was conducted to obtain data,~     such as safety and effectiveness, from the use of lopinavir/ritonavir (Kaletra) in clinical~     practice and investigate the necessity to conduct a follow-up post-marketing clinical study~     in Japan.~   "
190040|NCT01076959|"~     To clarify the following matters:~        -  Unknown adverse reactions (especially clinically significant adverse reactions)~        -  Incidence and conditions of occurrence of adverse reactions in the clinical setting~        -  Factors that may affect the safety and effectiveness of Humira~   "
190041|NCT01076946|"~     Transient left ventricular ballooning syndrome (TLVBS) is a cardiac syndrome that is~     characterised by acute but transient left ventricular (LV) dysfunction.~      Since the syndrome clearly is not a rare phenomenon and since prognosis is not as benign as~     originally thought, there is a need for further research into the etiology and~     pathophysiology of TLVBS. Therefore the investigators aim to study the microvascular and~     endothelial function in their population of TLVBS patients.~   "
190042|NCT01076933|"~     Primary purpose : to assess the effect on neuropsychological tasks related to planning of 10~     daily sessions of right dorsolateral prefrontal cortex with High-frequency repetitive~     transcranial magnetic stimulation (rTMS) on borderline personality disorder (BPD) patients.~      Hypothesis : BPD patients receiving 10 sessions of rTMS will have greater improvement in the~     average number of move to achieve tasks of the Tower of London, than those receiving sham~     rTMS.~   "
190043|NCT01076920|"~     Ischemic cardiomyopathies are a leading cause of death in both men and women. When a person~     has a heart attack, blood is unable to reach a certain area of the heart, and if the blood~     supply is not re-established quickly, that area of the heart can suffer permanent damage.~     While recovery from a heart attack can be managed through medications and lifestyle changes,~     these treatments can not reverse the all damage to the heart. Current research is focusing on~     the development of cell-based therapies using stem cells to repair organs that have been~     irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem~     cells (MSCs), has shown promise for heart repair. This study will evaluate the safety of~     injecting MSCs directly into the heart to repair and restore heart function in people who~     have had a heart attack and who have chronic myocardial ischemia with heart failure.~   "
190044|NCT01076907|"~     Hypotheses~        1. Loading the sigmoid colon with warm water and warm water irrigation for dealing with~          spasm (Study Treatment) will significantly reduce the proportion of patients complaining~          of abdominal discomfort compared with no water loading and waiting for spasms to subside~          (Control Treatment). The median discomfort score reported by the patients will be~          significantly lower in the group receiving the Study Treatment than the group receiving~          Control Treatment. Hypothesis~        2. Exploratory hypothesis: There are differences in secondary outcome variables when~          patients managed by the Study and Control Treatments are compared. Co-variables affect~          the primary and secondary outcome variables.~   "
190045|NCT01076894|"~     Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery~     still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia~     is commonly considered to be the gold standard for postoperative pain control and~     restoration of pulmonary function after thoracic surgery.~      Thus, the aim of the present study is to investigate whether an intercostal nerve block with~     ropivacaine plus intravenous PCA with morphine is as effective as thoracic epidural~     anesthesia with respect to postoperative pain control and pulmonary~   "
190046|NCT01076881|"~     This is a randomized trial with participants recruited from one dialysis unit of a Brazilian~     university hospital. Hemodialysis patients were assigned to receive the resistance exercise~     combined with an aerobic training or the resistance training alone for a period of 10 weeks.~     The functional performance of patients was assessed before and after the intervention through~     the six-minute walk test (6MWT). The difference over time of the 6MWT was compared between~     the groups through multivariate linear regression.~      Thirteen patients were allocated for each group of intervention. The difference in distance~     walked before and after intervention in the combined training group was of +39.7 (61.4)~     meters, and this difference in the resistance training group was of -19.2 (53.9) meters,~     p=0.01. In multivariate analysis with adjustment for age, skin color, gender, hematocrit,~     time since starting dialysis, Kt/V and baseline values of 6MWT, the type of training remained~     significantly associated with the amount of increase in walked distance.~      Although the best protocol of exercise for patients on dialysis is not yet clear, in the~     investigators sample of hemodialysis patients the combination of aerobic and resistance~     training was more effective to improve functional performance.~   "
190047|NCT01076868|"~     This is a continuous cohort study consisting of 200 participants (one third 6 months old to 5~     years, one third 6 to 15 years old, one third ≥ 15 years old) i.e. a new patient will be~     recruited (from the same age group) for any patient who develops a Pv infection so that the~     cohort will always have 200 patients for 3 years. Each patient will be actively followed-up~     every 8 weeks until Plasmodium vivax infection occurs but the duration of follow up and the~     number of follow up visits for each patient will vary depending on when or if a vivax~     infection occurs and when the patient is recruited. Therefore, the minimum follow up period~     for each patient will be 6 months or time to vivax infection and the maximum will be 3 years~     if a patient does not get vivax infection and is recruited at the beginning of the study.~   "
190048|NCT01076855|"~     The purpose of the programme is to facilitate the anticipation of dementia both in elderly~     patients suffering from this disease and in their carers and to diminish care burden in order~     to improve quality of life and daily functioning.~   "
190049|NCT01076842|"~     The purpose of this study is to compare the effectiveness of two different kinds of diabetes~     medications, insulin detemir (Levemir) and exenatide (Byetta), in improving blood sugar~     levels with little or no weight gain in patients with type 2 diabetes who are not well~     controlled on two or more oral (by mouth) diabetes medications. Both medications are given by~     injection with a very small needle just below the surface of your skin (called subcutaneous~     injection). The medication that you inject will be in addition to your oral medications.~   "
190050|NCT01076829|"~     Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly,~     in response to biotic or abiotic stresses such as infections, wounding, UV irradiation,~     exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that~     the molecular basis for the protective action of polyphenols in plants is their antioxidant~     and free radical scavenging properties. These numerous phenolic compounds are major~     biologically active components of spices, aromas, essential oils, and traditional medicines.~     In order to investigate the impact of spice polyphenols on postprandial flow-mediated~     dilation, nitric oxide, glucose, insulin, triglycerieds, oxidized LDL, and cytoxic lipid~     peroxidation products (MDA) levels in men with type 2 diabetes, the investigators propose to~     achieve the following specific aims using a randomized crossover study design:~        1. To determine the effect of a ground beef patty meal with and without polyphenol-rich~          spices on postprandial levels of plasma oxidized LDL, triglycerides, insulin, glucose,~          and malondialdehyde (MDA).~        2. To determine the effect of a ground beef patty meal with and without polyphenol-rich~          spices on postprandial levels of nitric oxide and flow-mediated dilation.~        3. To determine the effect of a ground beef patty meal with and without a spice blend on~          MDA accumulation in urine.~      This study will determine whether spice polyphenols exert a beneficial effect by inhibition~     of the absorption of lipotoxin MDA in males with type 2 diabetes mellitus.Men with diabetes~     mellitus type 2 have been selected for this study to enable assessment of markers of vascular~     health including nitric oxide in plasma and flow-mediated dilation. These findings may help~     to explain the potentially harmful effects of oxidizable fats found in foods and the~     important benefit of dietary polyphenols in ameliorating this potentially harmful effect.~   "
190051|NCT01076816|"~     Currently, dexmedetomidine is approved by the United States Food and Drug Administration~     (FDA) for short-term analgosedation (<24h) in mechanically-ventilated critical care adult~     patients and sedation of non-intubated adult patients prior to and/or during surgical and~     other procedures. Trials are underway to investigate its pharmacokinetics, clinical efficacy~     and safety in long-term use. Clinical experience with dexmedetomidine in the paediatric~     population is limited. Moreover, during childhood many developmental changes take place with~     consequences on drug exposure and drug response. Finally, critical illness itself can affect~     drug pharmacokinetics and -dynamics. Therefore, we cannot simply extrapolate adult data for~     use in children but we are in need of data on pharmacokinetics and pharmacodynamics in every~     paediatric subpopulation.~   "
190052|NCT01076803|"~     The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the~     relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This~     effect will be evaluated by the percentage of responder patients 7 and 14 days after one~     administration of lanreotide 120 mg.~      (A responder patient will be defined either as a patient experiencing < or= 1 vomiting~     episode per day during at least three consecutive days or as a patient in whom NGT has been~     removed without any vomiting recurrence during at least three consecutive days)~      The total number of visits will depend on the clinical situation, 5 visits are obligatory:~     Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28~      Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs,~     diary cards, VAS scale, cc medication, blood sample~      Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of~     biochemical analyse, adverse events, cc medication~      In between the visits, the patient will keep and fill out his diary and VAS scale~   "
190053|NCT01076790|"~     Dexmedetomidine acts at central nervous system (specifically: at locus caeruleus), providing~     sedative and analgesic effects. It is widely used in intensive care. Surgery-related~     interventions elicit arousal ('nociceptive') reactions. The effects of dexmedetomidine on the~     neurophysiological signs of arousal are studied in surgical patients. Brain waves,~     electrocardiogram, Entropy Index, Bispectral Index, and fingertip pulse waves are recorded~     and analyzed later on. The course of anaesthesia and surgery are recorded.~   "
190054|NCT01076777|"~     The purpose of this study is to compare manualised physical exercise conducted in groups to~     manualised cognitive-behavioral therapy conducted in groups as treatment for panic disorder~     with or without agoraphobia.~   "
190080|NCT01076439|"~     The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal~     spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic~     signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose~     administration and six consecutive days of treatment.~   "
190055|NCT01076764|"~     Primary Objective:~        -  To demonstrate the superior efficacy (composite of all-cause death + Myocardial~          Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide~      Secondary Objectives:~        -  To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of~          Otamixaban as compared to UFH + Eptifibatide~        -  To document the effect of Otamixaban on rehospitalization or prolongation of~          hospitalization due to a new episode of myocardial ischemia/myocardial infarction as~          compared to UFH + eptifibatide~        -  To document the effect on mortality (all cause death) of Otamixaban as compared to UFH +~          eptifibatide~        -  To document the safety of Otamixaban as compared to UFH + eptifibatide~        -  To document the effect of Otamixaban on thrombotic procedural complications during the~          index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide~   "
190056|NCT01076751|"~     Primary Objective:~        -  Describe real-life survival of CRPC patients who received first-line docetaxel and have~          disease progression~      Secondary Objective:~        -  Describe treatment patterns~        -  Describe the characteristics and outcomes of patients who received second-line~          taxane-based treatment compared to others~        -  Describe economic and patient-reported outcomes~   "
190057|NCT01076738|"~     Primary Objective:~      To investigate the value of the Edinburgh Claudication Questionnaire (ECQ) against the~     ankle-brachial index (ABI) in Canadian patients mainly followed in general practice, with~     documented acute coronary syndrome (ACS)/ischemic stroke (IS)/transient ischemic attack (TIA)~     and who are not known to have peripheral arterial disease (PAD) at the time of enrolment.~      Secondary Objective:~      To collect data on the prevalence of PAD in this population as measured by ABI.~   "
190058|NCT01076725|"~     Insertion of the ProSeal laryngeal mask airway in pediatric patients using the 90 degree~     rotational technique is more successful and causes less pharyngeal trauma than the standard~     technique in pediatric patients.~   "
190059|NCT01076712|"~     Parkinson's Disease is an incurable and progressive disease. Treatment includes medication~     and non-pharmacological intervention such as physiotherapy. Physiotherapy is a main component~     of non-pharmacological interventions. It includes exercise to strengthen the muscles;~     improves balance and walking, and adopts the use of visual cue training. Treatment has been~     found to be effective in patients with mild impairment up to 6 months post-treatment. The~     present study will investigate the effectiveness of treatment for patients with mild to~     moderate impairment for short term (3-month) and long term (1 year). The hypothesis is that~     compared to patient education alone, physiotherapy intervention for patients with Parkinson's~     disease leads to improve function and quality of life.~   "
190060|NCT01076699|"~     The purpose of this study is to determine if RVX-100 is safe and effective in treating acute~     abdominal pain in patients with irritable bowel syndrome accompanied by diarrhea.~   "
190061|NCT01076686|"~     A history and physical focused on clinical sequelae of breast implant rupture was completed~     by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon~     shell.~   "
190062|NCT01076673|"~     The purpose of this study was to compare histologic and MRI evaluation of articular cartilage~     regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling~     followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without~     peripheral blood stem cells (PBSC)~   "
190063|NCT01076660|"~     Sudden cardiac death (SCD) poses a significant health care challenge with high annual~     incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD~     in patients with poor heart function. However, the critical survival benefit afforded by the~     devices is accompanied by short and long-term complications and a high economic burden.~     Moreover, in using current practice guidelines of reduced heart function, specifically left~     ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient~     selection, only a minority of patients actually benefit from ICD therapy (<25% in 5 years).~     There is an essential need for more robust diagnostic approaches to SCD risk stratification.~      This project examines the hypothesis that structural abnormalities of the heart itself, above~     and beyond global LV dysfunction, are important predictors of SCD risk since they indicate~     the presence of the abnormal tissue substrate required for the abnormal electrical circuits~     and heart rhythms that actually lead to SCD. Information about the heart's structure will be~     obtained from cardiac magnetic resonance imaging and used in combination with a number of~     other clinical risk factors to see if certain characteristics can better predict patients at~     risk for SCD.~   "
190064|NCT01076647|"~     This trial was conducted in Europe and North America. The aim of this clinical trial was to~     compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with~     insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or~     DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with~     oral anti-diabetic drugs (OADs).~   "
190065|NCT01076634|"~     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic~     properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects~     with type 1 diabetes.~   "
190066|NCT01076621|"~     This study is conducted in Europe. The primary aim of this observational study is to~     investigate the occurrence of bleeding in women taking 0.5 mg estradiol and 0.1 mg~     norethisterone acetate (NETA) for 12 months.~   "
190081|NCT01076426|"~     The purpose of this study is to determine whether probiotics can improve the nutrition status~     and prevent peritonitis in the chronic peritoneal dialysis patients.~   "
190082|NCT01076413|"~     The purpose of this research study is to compare two different exercise treatments for~     walking problems in older adults. The investigators want to determine if participation in the~     exercise programs for 3 months will improve walking abilities by improving balance and~     strength.~   "
190100|NCT01076179|"~     The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir)~     in combination with new substances such as integrase inhibitors (INIs), C-C chemokine~     receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors~     (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even~     personal reasons) which may result in a change from the daily clinical routine and lead to~     the use of a newly approved antiretroviral agent in combination with Kaletra.~   "
190101|NCT01076166|"~     Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children~     with lower respiratory tract infections.~   "
190067|NCT01076608|"~     Cardiovascular diseases are, along with cancer, the most frequent causes for mortality and~     morbidity in the industrialized nations. Numerous clinical efficient approaches to reduce the~     known risk factors have been introduced in clinical routine care; yet with quite limited~     success, e.g. modification of behavioral risk factors, drug treatment and the combination of~     both. On the population level only marginal changes have been demonstrated, i.e. the~     mortality from myocardial infarction and stroke remains high.~      To answer questions about underlying factors, for this unsatisfactory status, we might profit~     tremendously from studies that examine the situation, where treatment of patients most~     frequently take place: in primary care. This approach pays attention to the General~     Practitioner's (GP) in their gate keeping function in health care. Information from primary~     care in particular is largely lacking as recently stated by the Sachverständigenrat für die~     konzertierte Aktion im Gesundheitswesen in 2001. The DETECT study has been designed to~     address these critical issues.~      On 16th and 18th September 2003, 3,188 GPs completed a standardised assessment of the~     diagnostic and therapeutic profile of 55,518 unselected consecutive patients. All patients~     completed a questionnaire on their demographic data, their complaints, their illness history,~     their knowledge about selected diseases and their attitude towards those. A sub sample of~     7,519 patients additionally attended a standardized laboratory screening program. In this~     screening the focus was on blood constituents connected with cardiovascular diseases and~     diabetes, including e. g. cholesterol, lipoproteins, triglycerides and HbA1c. These patients~     were assessed a second time in the follow up period after one year in 2004 and for a final~     time after completion of the five-year follow-up period.~   "
190068|NCT01076595|"~     The aim of the SEPLUS study is to evaluate the patients characteristics associated with~     adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in~     the BetaPlus program~   "
190069|NCT01076582|"~     This clinical research study will examine whether an oral contraceptive pill taken with a~     monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms~     compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days~     after 4 cycles of treatment.~   "
190070|NCT01076569|"~     This pilot research trial studies biomarkers in bone marrow samples from pediatric patients~     with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with~     cancer in the laboratory may help doctors identify and learn more about biomarkers related to~     cancer.~   "
190071|NCT01076556|"~     This phase I trial is studying the side effects and the best dose of alvocidib when given~     together with cyclophosphamide and rituximab in treating patients with high risk B-cell~     chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such~     as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Alvocidib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     rituximab, can also block cancer growth in different ways. Some block the ability of cancer~     cells to grow and spread. Other find cancer cells and help kill them or carry cancer-killing~     substances to them. Giving cyclophosphamide, alvocidib, and rituximab together may kill more~     cancer cells.~   "
190072|NCT01076543|"~     This phase I/II trial studies the side effects and the best dose of lenalidomide when given~     together with temsirolimus and to see how well it works in treating patients with Hodgkin~     lymphoma or non-Hodgkin lymphoma that has come back after a period of improvement or is not~     responding to treatment. Biological therapies, such as lenalidomide, may stimulate the immune~     system in different ways and stop cancer cells from growing. Lenalidomide may also stop the~     growth of Hodgkin lymphoma or non-Hodgkin lymphoma by blocking blood flow to the cancer.~     Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving lenalidomide together with temsirolimus may kill more cancer cells.~   "
190073|NCT01076530|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with temozolomide in treating young patients with relapsed or refractory primary~     brain tumors or spinal cord tumors. Vorinostat may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Vorinostat may help temozolomide work better by making tumor~     cells more sensitive to the drug.~   "
190074|NCT01076517|"~     To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.~   "
190075|NCT01076504|"~     This proposed trial will investigate the combination of amrubicin and carboplatin in the~     first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC).~     Since myelosuppression is the most common toxicity produced by this drug combination,~     pegfilgrastim will be administered with each treatment cycle. This trial will be the first~     clinical trial to evaluate a combination of amrubicin and carboplatin in the first-line~     treatment of ES SCLC in a U.S. population.~   "
190076|NCT01076491|"~     This study is to investigate the safety and tolerability of high doses of inhaled mannitol in~     subjects with bronchiectasis to further direct development of an improved drug delivery~     system.~   "
190077|NCT01076478|"~     To describe if there are differences in the subjective, objective and electrophysiologic~     parameters of diabetic polyneuropathies at baseline, four (4) weeks, eight (8) weeks, and~     twelve (12) weeks after Cilostazol therapy.~   "
190078|NCT01076465|"~     The purpose of this study is to assess the efficacy of a disease management programme (DMP)~     for very old patients with HF and significant co-morbidity.~      METHODS: A multicenter randomized trial will be conducted with 700 patients with heart~     failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments~     in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care.~     Randomization will be stratified by hospital and performed with concealment of the allocation~     list.~      The DMP will be conducted by a case manager, and will include three main components:~        1. patient education to improve disease' knowledge and self-care~        2. monitoring of clinical status~        3. therapeutic adherence. Main statistical analyses will be performed according to the~          intention-to-treat principle, and will use Cox regression models to examine the~          association of a DMP with hospital readmission, quality-of-life, and mortality over 12~          months.~   "
190079|NCT01076452|"~     The goal of the second phase of the study is to determine if simultaneous bilateral~     subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more~     effective in reducing symptoms of Parkinson's Disease.~   "
190102|NCT01076153|"~     The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery~     time in Thai patients with upper or lower respiratory tract infections.~   "
190083|NCT01076400|"~     This study will be conducted in two parts. Part 1 will determine whether administration of~     MK1775 in combination with topotecan and cisplatin is generally well-tolerated and causes~     clinical objective responses in patients with cervical cancer. Part 1 will also define the~     recommended Phase 2 dose and maximum tolerated dose (MTD) of the combination of MK1775 with~     topotecan and cisplatin. Part 2 of the study will evaluate whether treatment with MK1775 in~     combination with topotecan and cisplatin causes an improvement in progression-free survival~     (PFS) compared to treatment with topotecan and cisplatin alone and will further evaluate the~     tolerability of the combination treatment. The primary hypothesis is the combination of~     MK-1775, topotecan and cisplatin causes objective radiological responses (assessed per~     Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) in ≥30% of participants.~     Due to the early termination of the study by the sponsor, no participants were enrolled in~     Part 2 of the study.~   "
190084|NCT01076387|"~     The purpose of this study is to determine if using robotic surgical technology during bladder~     cancer surgery helps to reduce complications during and after the surgery. The removal of the~     bladder and lymph nodes will be done by a robotic or by an open technique. It may be a~     Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an~     Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.~   "
190085|NCT01076374|"~     The primary purpose of this study is to assess the long term reliability of the Medtronic~     Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of~     approval of nEw3 devices. Patients will be followed for 5 years after implant. This study~     utilizes data collected from the System Longevity Study (SLS).~   "
190086|NCT01076361|"~     The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968~     lead. This study is part of the Medtronic System Longevity Study.~   "
190087|NCT01076348|"~     Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted~     within Medtronic's System Longevity Study (SLS).~   "
190088|NCT01076335|"~     The goal of this clinical research study is to find out if a therapy using docetaxel~     chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to~     treatment of prostate cancer. The safety of this combination will also be studied.~   "
190089|NCT01076322|"~     This is an open-label, randomized, cross-over, active-controlled study to evaluate the~     efficacy and safety effects using Meptin® Swinghaler and Ventolin® MDI in stable asthma~     patients.~   "
190090|NCT01076309|"~     The purpose of this study is to determine whether corneal endothelium cell loss during~     cataract surgery is higher in patients taking Tamsulosin.~   "
190091|NCT01076296|"~     This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is~     an observational study with no additional procedures or intervention prescribed other than~     using the Vscan along with a routine medical physical exam.~   "
190092|NCT01076283|"~     This pilot trial has the goal to demonstrate the feasibility of a study to test the effects~     of baclofen in a laboratory experiment using cue-reactivity and alcohol-self administration~     paradigms in non-treatment seeking alcohol-dependent subjects.~   "
190093|NCT01076270|"~     RATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral~     blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor~     are infused into the patient they will help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as~     filgrastim (G-CSF) and plerixafor, to the donor helps the stem cells move (mobilization) from~     the bone marrow to the blood so they can be collected and stored.~      PURPOSE: This clinical trial is studying giving plerixafor and filgrastim together for~     mobilization of donor peripheral blood stem cells before a peripheral blood stem cell~     transplant in treating patients with hematologic malignancies~   "
190094|NCT01076257|"~     This research centers on the comparison of the immediate efficacy (right after therapy) and~     the maintained efficacy (3 months and 6 months) between Modified Constraint-Induced Movement~     Therapy (mCIMT) group and control group at different age.~   "
190095|NCT01076244|"~     This is a single-center study evaluating the outcomes of patients with painful lumbar spinal~     stenosis who were treated with the mild procedure (minimally invasive lumbar decompression.~     The patients will be followed for 6 months after the procedure.~   "
190096|NCT01076231|"~     RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that~     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause~     less damage to normal tissue in patients with non-small cell lung cancer. Drugs used in~     chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving proton~     beam radiation therapy together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of proton beam~     radiation therapy when given together with cisplatin and etoposide and to see how well it~     works in treating patients with stage III non-small cell lung cancer that can be removed by~     surgery.~   "
190097|NCT01076218|"~     The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the~     FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to~     the system algorithm and minor changes to the user interface and sensor delivery unit, such~     as adhesive sterilization method. It is anticipated that information collected will be~     submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug~     Administration for approval to market this version of the system.~   "
190098|NCT01076205|"~     The primary objective of the study is to explore the therapeutic success, measured by~     improvements in the following variables :~      - The number of missed working days~      The secondary objective is to document the therapeutic success by the following variables:~        -  The number of physician visits~        -  The number and duration of hospitalization~        -  The number of days of impairment in non-occupational activities~        -  The duration of morning stiffness, pain, exhaustion/fatigue~   "
190099|NCT01076192|"~     The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used~     in routine clinical practice in adult patients with moderate to severe chronic plaque~     psoriasis in Spain.~   "
190104|NCT01076127|"~     Neck/shoulder and back pain is quite common among employees in sedentary occupations.~     Furthermore, many have a low level of fitness. Strength training with dumbbells has been~     shown to alleviate neck/shoulder pain, but many people prefer to also have alternative~     training options. Empirically, kettlebell training works the neck/shoulder/back while at the~     same time training the cardiovascular system. This type of training has not previously been~     tested in a randomized controlled trial. The aim of this study is to test the effect of~     kettlebell training on musculoskeletal pain, fitness, and muscle strength.~   "
190105|NCT01076114|"~     The purpose of this study is to evaluate if critical flicker fusion is a more reliable method~     for detection of early glaucoma compared to automated visual fields in comparison to subjects~     without evidence of glaucoma or optic nerve disease.~   "
190106|NCT01076101|"~     This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These~     unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood~     sample.~   "
190107|NCT01076088|"~     This study will assess the efficacy and safety of initial treatment with sitagliptin and~     metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that~     after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided~     greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin~     alone and with metformin alone.~   "
190108|NCT01076075|"~     This study will evaluate whether the addition of Sitagliptin treatment provides a greater~     decrease in A1C levels compared to placebo in participants with inadequate glycemic control~     on sulfonylurea and metformin combination therapy.~   "
190109|NCT01076062|"~     Primary outcome: to evaluate the effect of elective induction of labor (IOL), at 39 weeks~     gestation, on cesarean delivery rates in nulliparous women compared to expectant management~     (EM).~      Secondary outcomes: to evaluate differences in the mean number of clinic visits/antepartum~     tests avoided with IOL, to compare the differences in utilization of inpatient resources~     (mean duration of inpatient stay, mean duration of labor), and to evaluate the effect of IOL~     on the risk of urinary/anal incontinence and sexual dysfunction as analyzed using previously~     validated measurements. We will evaluate differences in the rate of cervical change once~     active labor is diagnosed, and the time from completion of active labor, defined as complete~     dilation and complete effacement, to the delivery of fetus (definition of second stage of~     active labor). Furthermore, other secondary outcomes to be evaluated include comparisons~     between IOL and EM in regards to the occurence of chorioamnionitis, stillbirth, operative~     vaginal delivery, and meconium stained amniotic fluid. An evaluation of the predictive value~     of cervical length and Bishop score for vaginal delivery will also be examined.~   "
190110|NCT01076049|"~     Does irrigation with IrriSept prevent infected wound progression when compared to usual care?~   "
190111|NCT01076036|"~     An open-label, prospective, single-arm study is designed to evaluate safety, clinical and~     technical efficacy of the CorPath 200 System in delivery and manipulation of the coronary~     guide wires and balloon/stent systems for use in robotically-assisted, percutaneous coronary~     intervention (PCI) procedures.~   "
190112|NCT01076023|"~     This study is designed to assess the incidence of cardiovascular events occurred within an 12~     month follow up period in type 2 diabetic patients with either high risk of cardiovascular~     disease (CVD) or history of coronary artery disease (CAD) or stroke.~   "
190113|NCT01076010|"~     Open-label, multi-center extension treatment protocol to allow access to tivozanib and~     sorafenib for subjects who have participated on the AV-951-09-301 protocol. Eligible subjects~     who were randomized to receive sorafenib on AV-951-09-301 and had documented progression of~     disease will receive a tivozanib dose of 1.5 mg/day. Eligible subjects who were randomized to~     tivozanib or sorafenib in AV-951-09-301, and displayed clinical benefit and acceptable~     tolerability to treatment, will continue to receive tivozanib or sorafenib at the same dose~     and schedule as in AV-951-09-301.~   "
190114|NCT01075997|"~     The purpose of the study is to determine whether having a video cell phone that gives daily~     reminders over a 6-month period to check blood surgery and take your diabetes medications can~     improve your diabetes control during that time and if that benefit lasts for up to 1 year.~   "
190115|NCT01075984|"~     The purpose of this study is to collect pharmacokinetic (PK) information related to how well~     intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety and~     tolerability of this new formulation. In addition, the PK, safety, and tolerability of~     switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be~     evaluated. The data collected in this study will be compared to data collected in previous~     studies.~      Individuals who have been diagnosed by their physicians with a blood disease or cancer that~     can affect their infection-fighting white blood cells will be asked to participate in the~     trial. Since these blood diseases and their treatments can weaken the immune system, they may~     put these individuals at a high risk for getting a serious fungal infection of their internal~     organs or blood (invasive fungal infection). As these fungal infections can be hard to detect~     early and can be life-threatening, many physicians believe that individuals diagnosed with~     these diseases should receive antifungal therapy to try to lower their risk of getting this~     type of infection.~      Enrollment into this study will take place in several stages (cohorts). The determination of~     which cohort an individual will be asked to participate in is based on which cohort is open~     at the site at the time the individual is approached to consider study participation.~   "
190116|NCT01075971|"~     This is a multi-center, open-label, preference study of two sublingual formulations of~     buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy.~      The objectives of this study are to evaluate the overall preference between two buprenorphine~     sublingual formulations, after a switch from the marketed tablet (Subutex®) to the new fast~     dissolving tablet (FDT), in opioid-dependent patients with buprenorphine 8 mg or 16 mg daily~     maintenance therapy.~   "
190154|NCT01075477|"~     This observational study will assess the execution, efficacy and safety of treatment with~     MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera~     according to local treatment guidelines will be collected for 29 months. Target sample size~     is 100-200 patients.~   "
190155|NCT01075464|"~     This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with~     bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally~     advanced or metastatic solid tumors.~   "
190117|NCT01075958|"~     To date, the relationship between omega-3 polyunsaturated fatty acids (n-3 PUFAs) in~     cognitively intact individuals has only been examined in a limited number of studies; it is~     at present unknown whether supplementation with n-3 PUFAs can improve cognitive function and~     mood in this population. Further to this, it still remains to be established whether a~     relationship exists between peripheral fatty acid status—reflective of dietary n-3 PUFA~     intake—and cognitive function in this population. The current study therefore aims to address~     this issue by exploring the relationship between serum PUFAs and specific cognitive functions~     in a sample of healthy adults. To this end, participants will complete a range of cognitive~     tasks evaluating performance across the domains of attention, memory and executive function.~     Self-report mood assessments will be included as secondary measures.~   "
190118|NCT01075945|"~     Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine~   "
190119|NCT01075932|"~     DHA has previously been shown to increase regional cerebral blood flow response to tactile~     stimulation in aged monkeys; modulation of cerebral blood flow in humans has yet to be~     demonstrated. Given that the brain relies on a constant supply of blood-borne metabolic~     substrates (e.g. glucose, oxygen), increasing regional cerebral blood flow may also have an~     impact on cognitive function. The current study aims to investigate the effects of two doses~     of DHA-rich fish oil on task-related cerebral hemodynamic response and cognitive performance~     in healthy adults.~   "
190120|NCT01075919|"~     To date, only a small handful of studies have assessed the effects of omega-3 polyunsaturated~     fatty acids (n-3 PUFAs) on cognitive function in healthy adults. The results from these~     studies are mixed, and have differed greatly in terms of methodology as regards sample size,~     treatment formulation and duration of the intervention. In order to address these issues, the~     present study aims to assess the effects of two different formulations of fish oil in~     parallel, and at doses consistent with the current recommended daily intake of oily fish,~     across a range of cognitive domains. The aim of the present investigation is therefore to~     specifically evaluate the effects of 12 weeks supplementation of DHA-rich fish oil and~     EPA-rich fish oil dietary supplements on cognitive function in healthy young adults~     maintaining a regular diet containing oily fish not more than once a week. Self-report mood~     assessments will form the secondary part of this investigation.~   "
190121|NCT01075906|"~     Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean~     Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger~     patients by inexact dosing through breaking or crushing adult-dose tablets. An~     age-appropriate sprinkle formulation will allow for more accurate dosing in pediatric~     patients. The primary objective of this study is to evaluate and compare the steady-state~     pharmacokinetics of multiple oral doses of colchicine sprinkle capsules administered to~     pediatric and adult FMF patients.~      Secondary objectives include evaluation of the safety and tolerability of this regimen in~     pediatric and adult FMF patients and measurement of the levels of acute phase reactants (i.e,~     serum amyloid A [SAA], erythrocyte sedimentation rate [ESR], C-reactive protein [CRP]) at~     baseline and after dosing.~   "
190122|NCT01075893|"~     Colorectal cancer is a common disease worldwide. Increasing evidence is demonstrating that~     colorectal cancers arise from 'cancer stem cells.' Stem cells in the colon reside at the~     bottom of thousands of microscopic crypts throughout the wall of the colon. They create all~     the cells lining the bowel wall. These cells are created in the base of the crypt and ascend~     to the top acquiring the characteristics of mature cells of the bowel wall as they ascend.~      It is now thought that colorectal cancer cells arise from stem cells where the genetic~     material regulating growth and division of the stem cell has become defective. This leads to~     unregulated production of cells which in turn have defective genetic information and cancer~     formation.~      Prior studies have demonstrated that the earliest changes before a cancer develops are~     changes in cellular proliferation. Now that reliable markers to identify stem cells have been~     found, the researchers aim to investigate stem cell numbers and changes in distribution in~     those at normal risk of colorectal cancer and those at higher risk. The researchers~     hypothesise that changes in cellular proliferation at the top of the crypt in individuals at~     higher risk of colorectal cancer are due to a change in the number of stem cells in the crypt~     base.~   "
190123|NCT01075880|"~     The study is planned to evaluate the cognitive functions in subjects with RRMS treated with~     interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.~   "
190124|NCT01075867|"~     To demonstrate the effectiveness of the ELIPS programme (Multi-dimEnsionaL preventIon Program~     after Acute coronary Syndrome), which aims at improving quality of care of patients admitted~     to hospital with Acute Coronary Syndrome (ACS) in the Swiss setting. The program targets an~     increase in prescription rates by physicians and long term medication adherence and adoption~     of healthy lifestyle attitudes by patients.~      The program is dedicated to caregivers to increase their application of guidelines into~     practice, to increase their confidence in therapeutic education of patients, and to patients~     to improve their understanding of ACS and its treatment and to increase their motivation for~     long term treatment,.~   "
190125|NCT01075854|"~     This is a prospective, observational study in women using Gonal-F filled-by-mass (FbM) in~     ovarian hyperstimulation as part of their in-vitro fertilization (IVF) or intracytoplasmic~     sperm injection (ICSI) treatment at infertility clinics in Korea. The purpose of this study~     is to assess Gonal-F FbM in a practical setting encompassing all subject groups and local~     practices.~   "
190126|NCT01075841|"~     This is a prospective post-marketing surveillance (PMS) study to collect safety information~     from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the head~     and neck (SCCHN) treated with Erbitux as final evaluable cases. This PMS study is requested~     by the Korean Regulatory Authorities. After approval of new indication in Korea, there is a~     requirement to investigate more than 600 subjects during six years, to continue monitoring~     and provide further information about safety and toxicity in clinical practice.~   "
190156|NCT01075451|"~     The purpose of this investigation is to study the relationships between antimicrobial~     stewardship program efforts, antimicrobial drug use, and infection control efforts to the~     incidence rates of hospital acquired infections with Staphylococcus aureus in a sample of US~     academic medical center hospitals.~   "
196543|NCT00990756|"~     The purpose of this study is to investigate safety and toleration of multiple inhaled doses~     as well as the time course of PF-03526299 concentration in the blood following dosing by dry~     powder inhaler.~   "
190127|NCT01075828|"~     After consultation with the Korean Health Authorities, the two Post-Authorization Safety~     Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one~     study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is~     requested by the Korean Health Authorities to continue monitoring of Erbitux and provide~     further information about safety and toxicity in clinical practice in at least 900 patients~     during 6 years.~      All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain~     unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately~     disclose the EMR 062202-551 study titled A Korean Post-Marketing Surveillance Study On~     Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic~     Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With~     EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509) on~     clinicaltrials.gov.~   "
190128|NCT01075815|"~     This is a multicentric, open, randomized, comparative trial aimed to assess the influence of~     recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation~     (COS) in advanced reproductive age in terms of improved embryo competence which allows to~     transfer less embryos to avoid high grade multiple pregnancy without reducing the pregnancy~     rate.~   "
190129|NCT01075802|"~     Tamoxifen is an important drug for the treatment of breast cancer. Used adjuvantly after~     operation in early breast cancer, tamoxifen reduces annual recurrence rate by half and cancer~     death by one third. Used preventatively it also reduces the risk of breast cancer by 50% in~     women at high risk for developing the disease Tamoxifen needs to be activated in the body to~     an active form called endoxifen, mainly by the enzyme called CYP2D6. Patients have variable~     capability to activate tamoxifen due to variable function of this enzyme. Studies showed~     clear correlation of specific genetic variant of CYP2D6 with endoxifen blood levels. It is~     estimated that up to 25% Caucasian population have reduced or even absent CYP2D6 function.~     More recently, there were studies that showed the correlation with genetic variant of CYP2D6~     and breast cancer relapse in early breast cancer patients treated with tamoxifen. Food and~     Drug Authority (FDA) in America and recommended checking CYP2D6 genotype in patients~     receiving tamoxifen treatment, but they did not specify how to interpret the genotype results~     and what kind actions to take in patient with adverse genotype. The aim of the investigators~     study is to see if increasing tamoxifen in patients with genetic polymorphism of CYP2D6 will~     increase endoxifen level to the same range of most patients who have wild type (normal~     functional)CYP2D6.~   "
190130|NCT01075789|"~     Nasogastric tube insertion is one of the most common invasive procedures performed in~     children's hospitals, and has long been recognised as one of the most traumatic and painful.~     As a once off procedure, a nasogastric tube insertion is extremely distressing but the~     repeated procedures that many children endure as a necessary part of treatment for a chronic~     disease can be so traumatic that psychological damage may occur. There have been a limited~     number of studies carried out which have looked at methods to reduce the pain and trauma~     associated with this procedure, but most of these have been carried out in the adult~     population.~      The investigators propose to carry out a research project in a paediatric setting to~     definitively investigate the use of local anaesthetic spray, in combination with local~     anaesthetic gel, to numb the nasal passages and the back of the throat, with the aim of~     reducing or removing the unpleasant sensation of the nasogastric tube placement. If the study~     shows a benefit from the use of local anaesthetics, it would be an inexpensive and easily~     incorporated intervention that could be inserted into the routine procedure for nasogastric~     tube insertion.~   "
190131|NCT01075776|"~     To determine the effects of whether increasing CNP concentrations slightly above normal will~     improve the functioning of blood vessels after the interruption in the flow of blood. In this~     study we are looking at the function of the blood vessels of the forearm, as a substitute for~     those in the heart~   "
190132|NCT01075763|"~     This was a 52-week, multicentric, phase II, pilot study conducted in 40 subjects with~     early-onset Alzheimer's disease (AD) to evaluate safety, tolerability and clinical efficacy~     of subcutaneous (sc) interferon (IFN) beta-1a [Rebif® 22 microgram (mcg), three times per~     week (tiw)] in the treatment of AD by comparing the neuropsychological performance changes~     into placebo and treatment arms from screening/baseline to 52 week.~   "
190133|NCT01075750|"~     In this study we want to show that the choice of a balanced type fluid solution for the~     perioperative fluid management of patients receiving cadaveric renal transplantation results~     in less occurrence of intra- and postoperative hyperkalemia, and thus the need for~     postoperative dialysis. Additionally, we aim to determine whether the use of a balanced~     infusion solution leads to less occurrence of metabolic acidosis and electrolyte disorders~     than the use of isotonic saline.~      Furthermore we want to evaluate whether perioperative fluid management with balanced infusion~     solutions results in a higher frequency of primary graft function than with administration of~     isotonic saline.~      We will test the hypothesis that the use of Elomel isoton(Fresenius Kabi Austria GmbH) a~     balanced infusion solution will result in less occurrence of hyperkalemia and consequent~     post-transplant dialysis, less occurrence of metabolic acidosis, decreased incidence of~     electrolyte disorders and higher incidence of primary graft function when compared to~     isotonic saline for perioperative fluid management in patients receiving cadaveric renal~     transplantation.~   "
190134|NCT01075737|"~     This is an observational, non controlled, non-interventional, multicentric, prospective study~     planned to be conducted in 450 subjects diagnosed with MS and their caregivers in 20 centres~     of Argentina. The observations from this study will contribute to the awareness of the impact~     on the Quality of Life (QoL) of the caregivers and, eventually will also provide measures for~     helping the subjects with multiple sclerosis (MS) without leaving aside the care of the~     physical and psychic health of those who work as caregivers.~   "
190152|NCT01075503|"~     Brachial plexus block is a frequently used technique for upper extremity surgery. All present~     approaches and techniques have certain advantages and disadvantages. It's necessary to~     develop a new approach to brachial plexus block which 1) provides reliable anesthesia, 2) is~     easy to perform, 3) isn't restricted by posture, 4) provides extensive sensory distribution,~     5) causes as few complications as possible, 6) easily place a secured catheter for~     post-operative analgesia. The investigators established the retrograde infraclavicular~     brachial plexus block approach. The investigators compared and verified the feasibility,~     efficacy and safety of this new approach with other classic approaches to brachial plexus~     block.~   "
190135|NCT01075724|"~     Intraoperative active warming is usually performed by skin warming. There are several~     forced-air systems on the market; forced air warming is generally described as the most~     effective yet feasible method of patient warming.~      Augustine Biomedical (Eden Prairie, MN, USA) recently introduced a new patient warming system~     named Hot Dog with an active polymer warming upper-body blanket and a new under-body~     warming mattress. The polymer-heating devices consist of an electronic regulator and the~     polymer blankets, which are covered with a washable fabric. Conventional mains power the~     system. The manufacturer claims, that the new system Hot Dog (with combination of under~     body and upper body warming) is as effective as forced air warming, while not having any~     disadvantages of the forced air system, like: airborne infection, noise, high power~     consumption and hard-to-clean hose.~      The investigators will compare the new Hot Dog patient warming device combination (under body~     + upper body) with the established warming system, which blows warm air via a mattress over~     the body of the patients).~   "
190136|NCT01075711|"~     Rheumatoid arthritis is the most common rheumatic disease with symptomatic morning stiffness~     which entails a quite essential restriction in the everyday life and in the life quality.~     This observational, uncontrolled, multicentric study is aimed to assess the improvement in~     the activity status or QoL of subjects with RA being treated with the Tempus tablet.~   "
190137|NCT01075698|"~     The present research is conducted as a randomized, parallel-group, controlled, open study~     (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk~     hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in~     patients receiving ordinary therapy (non-ARB group (ordinary therapy group)). In addition,~     onset of cardiovascular events and levels of markers that are associated with cardiovascular~     events are observed over time to examine the significance of each marker. The biomarkers will~     be obtained at the start of the study (at registration), after 6, 12, 24 and 36 months from~     the start of the study.~   "
190138|NCT01075685|"~     The purpose of this study is to determine whether the investigators internet-based~     intervention is effective to help hazardous drinkers reducing their alcohol consumption.~   "
190139|NCT01075672|"~     To examine the effectiveness and clinical care outcomes of cognitive-behavioral therapy~     interventions at Massachusetts General Hospital (MGH).~   "
190140|NCT01075659|"~     A comparison of two products for oral nicotine replacement with respect to relief of urges to~     smoke after single doses of nicotine.~   "
190141|NCT01075646|"~     The purpose of this study is to determine whether a continuous infusion of local anesthesia~     with a catheter in the surgical wound reduces patient consumption of opiates by 30% in the~     48-hour postoperative period following surgery for colorectal neoplasm and hepatic surgery~     versus the continuous infusion of physiological serum.~   "
190142|NCT01075633|"~     This study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal~     occult blood test (iFOBT) and colonoscopy when positive for colorectal cancer (CRC) screening~     in familiar-risk population and; 2) to determine the complications associated with both~     strategies.~   "
190143|NCT01075620|"~     The purpose of this study is to determine if there are any clinical or radiographic~     differences in non-posterior stabilized rotating mobile bearing design versus a posterior~     stabilized rotating mobile bearing designs.~   "
190144|NCT01075607|"~     The objective of this study is to identify and validate metastasis protein markers in lymph~     collected from women with metastatic breast cancer. We will examine peripheral blood for the~     presence of these identified markers in order to develop a user friendly clinical test to~     detect metastasis and to evaluate response to therapy.~   "
190145|NCT01075594|"~     The purpose of this study is to establish the proportion of Bulgarian patients on~     lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth~     Joint European Task Force guidelines.~   "
190146|NCT01075581|"~     Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS)~     to reduce bleeding in the nasal mucosa and thereby improve visualization of the surgical~     field. However, systemic absorption of epinephrine via the nasal mucosa is often accompanied~     by cardiovascular side effects during the early postinjection period, putting in risk~     patients with cardiovascular morbidity. Evidence indicate that topical administration of~     epinephrine achieves similar hemostatic effects compared with injection of epinephrine, while~     avoiding systemic adverse effects. We wish to conduct a prospective controlled trial~     assessing the hemostatic and hemodynamic effects of intranasal injection compared to topical~     application of epinephrin during ESS, in order to evaluate whether the previous could be~     avoided due to its untoward effects.~      We hypothesize that topical administration of epinephrine provides a hemostatic effect not~     inferior to that of intranasal injection while minimizing hemodynamic instability during ESS.~   "
190147|NCT01075568|"~     To examine the satiety effect after eating of Okara.~   "
190148|NCT01075555|"~     RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of~     liver cancer by blocking blood flow to the tumor. It is not yet known whether sorafenib~     tosylate is more effective when given alone or together with pravastatin in treating patients~     with liver cancer and cirrhosis.~      PURPOSE: This randomized phase III trial is studying sorafenib tosylate given together with~     pravastatin to see how well it works compared with giving sorafenib tosylate alone in~     treating patients with liver cancer and cirrhosis.~   "
190149|NCT01075542|"~     The purpose of this study is to determine if Toric intraocular lens implantation in cataract~     surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal~     intraocular lens implantation.~   "
190150|NCT01075529|"~     The purpose of this study is to identify what degree of symptom changes during the early~     weeks could be used to predict eventual nonresponse at week 6 among depressive inpatients~     taking fluoxetine.~   "
190151|NCT01075516|"~     The purpose of the study is to define the economic value of implantable cardioverter~     defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy. Aims~     of the study are to develop a hospital cost minimization analysis and a cost effectiveness~     analysis based on direct estimation of costs and quality of life deriving from remote follow~     up (performed with Merlin@home and Merlin.net) compared to standard follow up in the~     management of ICD implanted patients.~   "
190157|NCT01075438|"~     Ataxia-telangiectasia (AT) is a rare genetic disorder characterized by gait disorders,~     neuromotor dysfunction, eye abnormalities and immune deficiency. AT patients are vulnerable~     to cancer and infection and usually die during their 2nd or 3rd decade due to these~     complications. The main cause of death is respiratory infections because these patients are~     known to have severe type of immunodeficiency. Consequently, pneumonia is the most common~     infection seen in AT patients, and is usually caused by S. pneumoniae. Therefore, a routine~     schedule of pneumococcal vaccine is highly recommended in AT cases where immunoglobulin~     replacement therapy was not already initiated.~      Until recently, AT patients were immunized with the pneumococcal polysaccharide vaccine~     (PPV23, Pneumovax® Aventis Pasteur MSD). However, data have shown that they do not respond~     well to these vaccines. Recently, the Israeli Ministry of Health has approved the~     pneumococcal 7-valent conjugate vaccine (PCV7, Prevenar®, Wyeth Lederle) for AT patients of~     all ages. This conjugate vaccine is known to stimulate the immune system through a different~     mechanism and the response is expected to be higher. The approved Israeli schedule for~     immunization of AT patients includes children older than 2 years that are entitled to receive~     2 doses of PCV7 (8 weeks apart) boosted by PPV23, eight weeks after the second dose of PCV7.~     Assessment of the antibody response of such pneumococcal vaccination protocol in AT patients~     has never been performed.~      The Safra Children's Hospital is the national multi-disciplinary center caring for AT~     patients. Approximately 50 patients from all over the country (including Jewish, Druze,~     Bedouin and other Muslim patients - 3 of whom are Palestinians) are followed in the clinic on~     a monthly basis.~      Approximately 20 AT patients are not receiving IVIG replacement therapy, therefore are~     entitled to receive pneumococcal vaccination as stated above (mean age 10.6, 3 -23 years, 3~     less than 5 years)~      The aim of this study is to evaluate the responsiveness, determined by specific antibody~     production, of AT patients receiving this new vaccine protocol.~   "
190158|NCT01075425|"~     RATIONALE: Belinostat and bortezomib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Giving belinostat together with bortezomib may kill more~     cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of~     giving belinostat together with bortezomib in treating patients with relapsed or refractory~     acute leukemia or myelodysplastic syndrome.~   "
190159|NCT01075412|"~     Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to~     metabolically active tumor.~      This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The~     radiation plan is then designed to spare that area, in hopes of keeping the bone marrow~     active during therapy. Bone marrow and tumor activity will be monitored using a sequence of~     FLT PET scans during the course of chemotherapy and radiation therapy.~   "
190160|NCT01075399|"~     This pilot phase II study is designed as a test and retest study to investigate [F 18]HX4 as~     a reliable non-invasive PET imaging marker for detection of tumor hypoxia regions and to~     establish a threshold for [F 18]HX4 uptake in the tumor. The study will evaluate the~     relationship between hypoxia biomarkers (HIF1α and CA-IX) by immunohistochemistry (IHC) and~     tumor uptake of [F 18]HX4 by PET imaging.~   "
190161|NCT01075386|"~     Endometrial cancer usually begins in the endometrium, which is the tissue lining of the~     uterus. Endometrial cancer is the most commonly diagnosed gynaecological malignancy in~     Australia. It affects 1 in 80 Australian women and there are about 1400 new cases and 260~     deaths from the disease every year. Most affected women are aged between 50 and 70 years. The~     purpose of this study is to investigate the possible role of the endocrine system in the~     regulation of human endometrial cancer. By looking at the laboratory results of people with~     endometrial cancer and also those without endometrial cancer we hope to gain a better~     understanding of how endometrial cancer develops and progresses. This may lead to the~     development of new, effective therapies for endometrial cancer.~   "
190162|NCT01075373|"~     Schizophrenia (SCH) is a devastating brain disorder with grave personal, family and social~     cost. SCH is a complex and heterogeneous (both genetic and clinical) disorder with~     oligogenetic endowed vulnerability risk of disease, which manifested as a clinical syndrome~     comprised of positive, negative and cognitive symptoms in late adolescent or young adulthood~     under the interaction with environmental stress. The fact that most positive psychotic~     symptoms can be well controlled by dopamine-blocking antipsychotics substantiates that~     dopamine hyperactivity is the pathophysiological model of SCH positive symptoms. This is the~     dopamine model of SCH.~      The presence of negative and cognitive symptoms has not being fully explained by the dopamine~     model. The hypo-glutaminergic function was hypothesized to replace or to supplement the~     dopamine pathological model. The hypo-glutaminergic state was due to a neurodevelopmental~     disturbance in early-stage of life, and was coined as a pathophysiological mechanism of SCH.~      The neurodevelopmental disturbance supports the hypo-glutamine model based on the~     cytoarchitecture abnormality in glutamate-pyramidal cells and reduced gray matter volume. We~     have found potential vulnerability genes of DISC1 and NRG1 in our Taiwanese SCH family~     samples. These two genes have functions on neurodevelopmental process. Besides, we, the~     investigators, also found two vulnerability genes of DRD2 receptor gene and COMT genes in our~     Taiwanese SCH families. The dopamine neurotransmission disturbance could be another~     pathophysiological mechanism of SCH.~      With the awareness of confounding variables of antipsychotic treatment response revealed in~     pharmacogenetic studies, such as drug metabolism related genes and plasma HVA level, we~     intend to test the etiological genetic hypotheses in antipsychotic treatment response: (1)~     The group of neurodevelopmental etiology with risk variations in DISC1 and NRG1 genes is of~     poor treatment response group; (2) The group of pure hyperdopamine etiology with risk~     variation in DRD2 receptor and COMT genes is of good treatment group.~      The potential treatment response related biomarkers, which are directly or indirectly induced~     by the etiological risk genetic variations, will be examined. These potential biomarkers~     include homovanillic acid (HVA), glutamate, serotonin, cytokines, and signaling proteins, the~     neurocognitive function, event-related evoked potential, Niacin skin test, and the AKT1 level~     in the peripheral lymphocytes.~      After obtained the informed consult, we'll recruit 30 drug-naïve early schizophrenia (first~     episode or prodromal stage) patients for pre-treatment and post-treatment assessment on~     treatment response using positive and negative syndrome scale (PANSS), changes in biomarkers~     (including biochemical, electro-physiological and neuro-cognitive variables), and brain~     imaging (studies of component Project No.2 of this Integrated Program) of PET, fMRI, MRI, DSI~     and MRS (please refer to Project No.2) in addition to genotyping on DISC1, NRG1, DRD2 and~     COMT genes. The treatment agent is the dopamine stabilizing agent (aripiprazole, 15mg/day for~     4 weeks) taking the advantage of dopamine activity balancing effect. Besides, we'll recruit~     30 normal controls matched with age, gender, and education, who will receive genotyping and~     evaluations in all biomarker variables, and brain imaging studies.~      In order to have adequate statistical power in the genetic analysis of 17 SNP variations in 4~     vulnerability genes of DISC1, NRG1, DRD2, COMT, we'll recruit 200 more cases of schizophrenia~     with duration of illness less than 5 years, who have received regular clinical follow up and~     had good compliance on medication. The treatment response will be evaluated using PANSS.~     These cases will also receive all biomarker examinations and genotyping studies. For~     comparison, we'll also recruit 100 normal controls for study.~      We'll delineate the heterogeneity issue of schizophrenia using genetic variation,~     neurobiological biomarkers. This study result will be beneficial for understanding~     pathogenesis of SCH, and for developing better treatment and prevention methods.~   "
190163|NCT01075360|"~     Neuroblastoma (NB) is the most common malignant tumor of infancy. Approximately 60% of NB~     patients are clinically diagnosed as the stage IV disease and have a very poor prognosis with~     the 5-year survival rate no more than 30%. Molecular markers of NB have great impacts on the~     tumor behavior. MYCN amplification is the most well-known marker to predict a poor outcome in~     NB patients. However, how MYCN affects the NB cell behavior remains unknown. In our~     preliminary studies, we performed a genome-wide analysis of the differential gene expression~     in 10 NB tumors with MYCN amplification and 10 with normal MYCN copy number. We found that~     aromatic hydrocarbon receptor (AHR) reversely correlated with the MYCN expression. This~     relationship was verified in 83 NB tumor samples. In addition, positive AHR expression by~     immunostaining of NB tumors predicted a favorable prognosis. These lines of evidence~     demonstrate that AHR not only relates to the MYCN expression but also plays an important role~     in the tumorigenesis of NB. Therefore in this project we aim at further studying the~     relationship between AHR and MYCN. In addition, the possible role of AHR in the tumorigenesis~     of NB will be clarified. Specifically, we propose a 3-year project with the following three~     aims:~      Aim I. Determine the molecular relationship between AHR and MYCN expression. AHR has been~     shown to suppress the E2F1 expression. E2F1 reversely has been found to upregulate the~     expression of MYCN. In our preliminary microarray study, we also found that the expression~     E2F1 positively correlated with the MYCN expression but inversely correlated with the~     expression of AHR. Therefore, NB cells will be transfected with AHR expression vector or AHR~     siRNA, then the associated E2F1 and MYCN expression will be examined to clarify if AHR could~     regulate MYCN expression via E2F1. Furthermore, the E2F1 levels will also be manipulated to~     determine if the effect of AHR on MYCN depends on E2F1. In addition, the E2F1 expression in~     NB tumor samples will also be examined to clarify its in vivo role.~      Aim II. Determine the effect of AHR expression on the NB cell behavior. The baseline AHR~     expression levels in several NB cell lines will be examined. AHR is then overexpressed by~     gene transfection in NB cells. The cell proliferation, migration, and differentiation after~     AHR overexpression are evaluated. Furthermore the AHR expression in normal neuron cells is~     also examined, and suppressed by siRNA to if downregulation of AHR could lead to cancer~     development.~      Aim III. Determine if AHR could be a target of gene therapy for NB. NB cells with either~     normal MYCN or MYCN amplification before and after AHR gene transfection are inoculated into~     nude mice to demonstrate the effect of AHR expression on NB cells behavior in vivo. AHR is~     then transfected into the wild type NB tumor to see if the tumor growth could be suppressed~     by AHR expression. Then wild type tumor and tumors transfected with AHR are subjected~     microarray analysis to compare with the human tumor data set for evaluation of gene~     expression changes along with differential AHR expression. Altogether, our studies will not~     only establish the relationship between AHR and MYCN, but also allow us to depict the~     functional role of AHR-MYCN interaction in the tumorigenesis of NB.~   "
190164|NCT01075347|"~     Ophthalmology ,cornea Autologous serum has long been known to be effective to promote corneal~     epithelial wound healing in a variety of ocular surface disorders. However, its effectiveness~     for corneal epithelial defects due to pars plana vitrectomy (PPV) for diabetic retinopathy~     and penetrating keratoplasty has seldom been reported. In this study, we plan to perform a~     prospective study to determine the effectiveness of topical autologous serum as a primary~     treatment for corneal epithelial defect in patients undergoing vitrectomy for diabetic~     retinopathy and penetrating keratoplasty. All patients enrolled in this study have received~     corneal epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic~     retinopathy and penetrating keratoplasty. The patients were grouped into two treatment~     groups. In the control group, the patients receive conventional postoperative eye drops~     including topical steroid, antibiotic and mydriatics. In the experimental group, the patients~     receive topical autologous serum eye drops in addition to conventional postoperative eye~     drops. The duration for cornea surface to completely re-epithelize, the incidence of corneal~     complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer,~     corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of~     recurrent epithelial break down after initial epithelization will be compared between these~     two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty~     will be compared separately~   "
190316|NCT01073371|"~     This blinded randomized, crossover, three period study aim to evaluate the anesthetic~     efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3%~     prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the~     maxillary right canine, in 32 volunteers.~   "
190165|NCT01075334|"~     Many cases of male infertility are poorly understood and regarded as unexplained. Therefore,~     a etiological treatment for this condition can not be offered in most cases. A beneficial~     effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and~     folic acid. However, most studies lacked a sufficient power to detect a significant effect on~     pregnancy rates. In this study, infertile men with abnormal sperm quality parameters will be~     randomized to receive either carnitine-based food supplement (Porimore) or folate and Zinc~     Tablets.~   "
190166|NCT01075321|"~     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood~     flow to the cancer. Giving everolimus together with lenalidomide may be an effective~     treatment for lymphoma.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving~     everolimus and lenalidomide together and to see how well they work in treating patients with~     relapsed or refractory non-Hodgkin or Hodgkin lymphoma.~   "
190167|NCT01075308|"~     RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase II trial is studying how well SB939 works in treating patients with~     recurrent or metastatic prostate cancer.~   "
190168|NCT01075295|"~     The purpose of this study is to determine whether individuals with psychotic spectrum~     disorders ( Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar~     Disorder (Type I),Bipolar Disorder (Type II),Major Depressive Disorder With Psychotic~     Features,Substance-Induced Psychoses,Psychosis Not-Otherwise-Specified (NOS)randomly assigned~     to a stepped behavioral intervention for the prevention of weight gain will experience less~     weight gain than individuals who receive usual care. There are several studies that have~     examined the effect of pharmacological and non-pharmacological behavioural approaches for~     weight loss in patients with psychosis, however studies examining strategies for prevention~     of obesity are lacking. This study is an important and novel approach to studying the problem~     of obesity in those with psychosis.~   "
190169|NCT01075282|"~     The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin~     A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes.~     Participants must also be taking metformin and glimepiride.~   "
190170|NCT01075269|"~     Robotic assistance during thyroid surgery has been utilized clinically in Korea since late~     2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid~     gland. Compared with endoscopic thyroidectomy, the use of a robot in an endoscopic approach~     via the axilla provides a broader view of the thyroid bed, albeit from a lateral, as opposed~     to the conventional anterior, perspective. The wrist action of a surgical robot also provides~     a greater degree of movement than afforded by the use of simple endoscopic instruments, and~     tremor is eliminated.~      Although several reports on operative outcomes of the robotic technique have appeared, no~     prospective trials comparing the clinical results of robotic with conventional open~     thyroidectomy have been described. We therefore designed a prospective trial comparing~     outcomes, including postoperative distress and patient satisfaction, between patients~     undergoing robotic and conventional open thyroidectomy.~   "
190171|NCT01075256|"~     To evaluate the efficacy of two different concentrations of a tubule occlusion agent -~     calcium sodium phosphosilicate in treatment of dentine hypersensitivity~   "
190172|NCT01075243|"~     GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol~     1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic~     efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The~     duration of the entire study will be approximately 18 weeks. Each subject will have to come~     to the clinic for three visits (Screening, Treatment and Follow up visits).~   "
190173|NCT01075230|"~     The purpose of this study is to determine if there is a difference in hemoglobin level~     between patients undergoing total knee arthroplasty with and without platelet-rich plasma.~   "
190174|NCT01075217|"~     No significant differences is expected in observed motion artifacts, heat or pain reported~     during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.~   "
190175|NCT01075204|"~     The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore~     throat, and others), tolerability and compliance of treatment with clarithromycin once daily~     in patients with upper or lower respiratory tract infections in the routine clinical~     practice.~   "
190176|NCT01075191|"~     Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human~     Immunodeficiency Virus participants~   "
190177|NCT01075178|"~     Retrospective medical record review study of specific adverse events in children with~     congenital heart disease who received palivizumab for prophylaxis of serious respiratory~     syncytial virus infection and control subjects that did not receive palivizumab~   "
190178|NCT01075165|"~     In a burn population, conduct a prospective, double-blinded, randomized, controlled clinical~     trial to determine the ability of spray silicone to alter the physical characteristics of~     burn scar compared to a placebo.~   "
190179|NCT01075152|"~     The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal~     meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital~     discharge results in superior survival compared to standard initiation of ART started as an~     outpatient.~   "
190180|NCT01075139|"~     Research has shown that a high percentage of college students do not meet recommended~     national guidelines for physical activity or fruit/vegetable intake. The purpose of this~     study was to pilot test the short-term efficacy of a one-on-one, brief motivational~     intervention (BMI) designed to increase physical activity and fruit/vegetable intake. It was~     hypothesized that participants in the BMI condition would report greater physical activity~     and fruit/vegetable intake at follow-up than those in an education-only control condition.~   "
190181|NCT01075126|"~     It is hypothesized that Depakote will be better tolerated then lithium in treating African~     Americans with bipolar disorder.~   "
190182|NCT01075113|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with sorafenib tosylate in treating patients with advanced liver cancer. Sorafenib~     tosylate and vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth or by blocking blood flow to the tumor.~   "
190183|NCT01075100|"~     Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and~     triple negative breast cancer. Ixabepilone has substantial antitumor activity in~     taxane-refractory patients and novel combinations are needed in this poor prognosis~     population. Carboplatin in combination with gemcitabine or paclitaxel has activity in~     metastatic breast cancer (MBC); there is also demonstrated activity of the~     gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I~     study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of this~     combination at the doses and schedule proposed for this Phase II trial (BMS data on file).~   "
190184|NCT01075087|"~     The use of preoperative TAP block in laparoscopic bariatric surgery can improve the~     postoperative pain and quality of recovery in patients undergoing these procedures.~   "
190185|NCT01075074|"~     The use of pre-operative transversus abdominis plane block will reduce pain after outpatient~     laparoscopic gynecological surgery and improve quality of recovery.~   "
190186|NCT01075061|"~     Mirror movements are involuntary, symmetrical and simultaneous movements occurring on one~     side of the body that accompany controlateral voluntary movements. Congenital mirror~     movements (CMM) are characterized by childhood onset and the absence of additional~     manifestations. The aim of this study is to unravel the pathophysiology of the CMM that~     remains poorly elucidated. The combination of imaging studies and neurophysiological studies~     using transcranial magnetic stimulation in a homogeneous and relatively large group of~     patient is likely to allow us to better understand the underlying pathophysiology of the~     disorder. Using a linkage analysis approach we will try to identify a locus associated with~     CMM and related candidate genes.~   "
190187|NCT01075048|"~     ARQ 197 or placebo in combination with irinotecan and cetuximab in patients with metastatic~     colorectal cancer (CRC), in subjects with wild-type KRAS alleles who have failed front-line~     systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the~     recommended dose for Phase 2.~      After the recommended dose is determined for Phase 2, subjects receive study drug or placebo~     with irinotecan and cetuximab.~   "
190188|NCT01075035|"~     The purpose of this study is to determine whether the brains of persons with and without~     traumatic brain injury differ in a meaningful way when advanced technology images of the~     brain are taken using three newer technologies that visualize the brain using a combination~     of external/internal magnetic fields and radioactive tracers (molecules that emit detectable~     particles). The hope is that the results of this study will validate tools (help prove that~     diagnostic tools actually detect disease) for the diagnosis and treatment of traumatic brain~     injuries (TBI).~   "
190189|NCT01075022|"~     A Prospective Double-Blinded, Placebo Controlled, Randomized Trial comparing a single dose of~     Vitamin D (Colecalciferol) 300.00UI to placebo on patients with insulin resistance. Primary~     Outcome: Blood glucose and homeostasis model assessment for insulin resistance (HOMA-R) after~     90 days. Study hypothesis: Vitamin D treatment may improve insulin resistance and decrease~     glucose level, since there is an association between hypovitaminosis D and increased insulin~     resistance.~   "
190190|NCT01075009|"~     Antibiotic resistance in gram-negative bacteria continues to increase in US hospitals. This~     comes at a time when there are few new drugs in development that are active for these~     resistant organisms. The implication is that we must learn to use the drugs that we have more~     wisely and develop new strategies that will preserve existing agents. Antimicrobial~     stewardship programs are one strategy that many hospitals are adopting to improve the~     quality of antimicrobial use. The goal of this project is to develop a consortium of US~     academic medical centers that will allow characterization of the relationships between~     antibiotic use and rates of resistance for gram-negative pathogens, and to help hospital~     devise new strategies that will modify antibiotic use and possibly delay or reduce~     resistance.~      The specific hypotheses are:~        -  Hospitals with established or emerging resistance in gram-negative pathogens, including~          extended spectrum beta-lactamase (ESBL) producing organisms, carbapenem-resistant~          enterobacteriaceae (CRE)and carbapenem-resistant P. aeruginosa have a different pattern~          of antimicrobial drug use compared to hospitals with fewer of these organisms.~        -  Hospital use of ertapenem is not associated with the rates of carbapenem-resistant~          organisms.~   "
190191|NCT01074996|"~     A randomized , open-label, multicenter, phase II study to compare the efficacy of S-1 and S-1~     plus Leucovorin as second line treatment on gemcitabine-refractory patients with inoperable~     or advanced pancreatic cancers，investigate the correlation between efficacy and the~     expressions of thymidylate synthase, dihydropyrimidine dehydrogenase and orotate~     phosphoribosyltransferase~   "
190192|NCT01074983|"~     The intent of this study is to describe the proportion of trauma patients requiring oxygen~     before hospital arrival, the amount of oxygen they require, and whether or not the oxygen is~     beneficial to outcomes.~   "
190193|NCT01074970|"~     The purpose of this trial is to evaluate 2-year disease-free survival in this patient~     population treated with single agent cisplatin and patients treated with cisplatin in~     combination with Rucaparib following preoperative chemotherapy. Side effects and tolerability~     of this treatment in patients with residual disease following preoperative chemotherapy will~     also be observed and characterized.~   "
190194|NCT01074957|"~     Background: Although respiratory physiotherapy has been used in patients undergoing cardiac~     surgery, evidence lacks concerning its effectiveness. The aim of this study was to evaluate~     the efficacy of three physiotherapeutic protocols used to recover respiratory volumes in the~     postoperative period.~      Methods: Thirty five patients were randomly allocated into three groups. Exercise group (E)~     was oriented to progressive mobilization. Incentive Spirometry group (IS) performed deep~     breathings using VoldyneTM, while Breath-Stacking group (BS) performed successive inspiratory~     efforts using a facial mask adapted to an unidirectional valve. Both BS and IS also performed~     progressive mobilization. Forced spirometry was carried out in the pre-operative period and~     from the first to the fifth postoperative day. Statistical analysis used student t-test and~     ANOVA, and the differences were considered significant when p<0.05.~   "
190234|NCT01074437|"~     This is a prospective randomized, double-blind study to compare the clinical efficacy of~     infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy~     with corticosteroids and placebo. We hypothesize that a two-month treatment period with~     propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and~     vascularity when compared to corticosteroids used without propranolol for the same time~     period.~   "
190195|NCT01074944|"~     The primary objective of this study was to evaluate the efficacy and safety of once daily~     (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants~     with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of~     eliglustat tartrate (Genz-112638). The secondary objective was to evaluate the~     pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) was administered~     QD and BID in participants with Gaucher disease type 1 who had demonstrated clinical~     stability on BID dosing of eliglustat tartrate (Genz-112638).~   "
190196|NCT01074931|"~     This post-marketing observational study is conducted for obtaining data on clinical,~     biological and virological outcomes, compliance and tolerability of using a~     lopinavir/ritonavir (LPV/r) -containing regimen for the treatment of naïve or experienced~     patients infected with human immunodeficiency virus type 1 (HIV-1) in China.~      Although LPV/r is frequently used world-wide, the evaluation of the outcomes, compliance, and~     tolerance of anti-HIV strategies in real life is still a major challenge in the management of~     HIV-infected patients who are on a life-long therapy, especially in China.~      This study will help to develop effectiveness and safety profile of the lopinavir/ritonavir~     containing regimen in Chinese HIV-1 infected patients, provide more choices of anti-HIV-1~     strategies to Chinese experts and benefits Chinese HIV-1 infected patients.~   "
190197|NCT01074918|"~     The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium~     Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will~     also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium~     in the urine.~   "
190198|NCT01074905|"~     This is a randomised open label trial with follow up for 1 year. 660 adults and children~     above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either~     chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on~     the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The~     primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of~     Public Health recommended radical curative regimen of chloroquine and primaquine with the~     currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese~     border.~   "
190199|NCT01074892|"~     Randomized controlled multi-center study with three arms including 200 patients with low risk~     endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the~     following treatments:~        1. Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10~          day each cycle,~        2. MPA 10 mg continuously for 6 months,~        3. Mirena (Levonorgestrel) impregnated IUD for 6 months.~   "
190200|NCT01074879|"~     The mail goal of this randomized controlled, dietary intervention study is to investigate~     whether protein supplementation in combination with resistance exercise can increase muscle~     mass and strength in elderly. Loss of muscle mass and -strength is frequent in this group.~     Participants (N = 220, equal distribution between men and women) are randomized to one of~     three groups receiving different quantities and qualities of protein supplementation after~     exercise. The results of this study will be used to form recommendations regarding diet and~     exercise for the prevention of this frequent health problem in elderly.~   "
190201|NCT01074866|"~     The present study aims to compare various parameters reflecting patient-ventilator synchrony~     during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a~     group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory~     failure of various origin.~   "
190202|NCT01074853|"~     Current asthma medicines include inhalers. A common inhaler used in asthma is called a~     beta-agonist (for example salbutamol). They improve asthma symptoms by stimulating areas in~     the human airway resulting in widening of the human airway. Although these drugs are useful~     after the first dose, longterm use can cause worsening asthma symptoms.~      Beta-blockers are the complete opposite type of medication. Just now they are avoided in~     patients with asthma as after the first dose they can cause airway narrowing and cause an~     asthma attack.~      New research has suggested that long term use of beta-blockers can reduce airway inflammation~     which can improve asthma control and improve symptoms.~      This research was done in asthmatic patients who didn't need inhaled steroids to control~     their asthma. What the investigators want to do is see if the same benefit of beta-blocker~     use is asthma can be seen in people who take inhaled steroids.~   "
190203|NCT01074840|"~     The purpose of this study is to find out if there is a way to treat children with peanut~     allergy to help lower the risk of severe allergic reactions and also cause them to lose their~     allergy to peanuts and to understand what happens to their immune systems when they have~     viral infections while on therapy. The approach we will use to treat peanut allergy in this~     study is a process called desensitization.~      We think that children with a peanut allergy receiving peanut oral immunotherapy will be able~     to eat more peanuts without having a reaction by the end of the study than they could eat at~     the beginning. We also think that we will be able to measure changes in their immune system~     and their immune system's response to viruses while they are on therapy.~   "
190204|NCT01074827|"~     The objective of this study is to evaluate the effect of strength training for the lower~     extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The~     study is a randomized control trial with two groups and the intervention is 8 weeks of~     intensive strength training or treadmill walking. Primary outcome measure is walking ability,~     secondary outcome measures are balance, work economy and strength.~   "
190205|NCT01074814|"~     The purpose of this study is to determine the response rate, that is the % of patients with~     non-progression of their metastatic breast cancer after 4 months on treatment that was~     selected by molecular testing and proteomics.~   "
190235|NCT01074424|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how well patients will respond to treatment.~      PURPOSE: This research study is looking at biomarkers in blood samples from patients with~     invasive cervical cancer.~   "
190278|NCT01073865|"~     The purpose of this study is to examine the efficacy and safety as well as the~     characteristics of the female hormone and study medications after administration in~     pre-menopausal women with advanced or recurrent breast cancer who were randomised in a 1:1~     ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg~     depot group, both given in combination with tamoxifen tablets.~   "
190206|NCT01074801|"~     High variability of blood sugar levels and high incidence of night-time hypoglycaemia (low~     blood sugar) in young people with type 1 diabetes (T1D) make achieving the treatment goals in~     this population extremely challenging.~      Our ongoing research focuses on the development of a closed-loop glucose control in children~     and adolescents with T1D. The three components of the closed-loop system are a continuous~     glucose monitor, an insulin pump, and a computer-based algorithm. The studies performed thus~     far evaluated the efficacy and safety of overnight closed-loop glucose control. The results~     showed that overnight closed-loop improved control of blood glucose and prevented nocturnal~     hypoglycaemia, as compared to the conventional insulin pump therapy. The next objective is to~     evaluate the efficacy and safety of closed-loop insulin delivery over a prolonged time~     period, including the daytime, when normal living activities occur. This will pave the way~     for a more comprehensive use of closed loop systems to control glucose levels in T1D.~      The present study adopts an open-label, randomised, 2-period cross-over design whereby the~     safety and efficacy of closed-loop insulin therapy will be compared with the conventional~     insulin pump therapy in 12 adolescents with T1D. Participants aged 12 to 18 years will be~     randomised for two 36 hour studies in a clinical research facility, during which glucose~     levels will be controlled by either the computer-based closed-loop algorithm (intervention~     arm) or by conventional insulin pump therapy (control arm). During both studies participants~     will perform normal daily activities, i.e. playing, reading, snacking and physical activity.~     On both occasions, the Actiheart, a combined heart rate and movement sensor will be used to~     accurately quantify each subject's individual physical activity energy expenditure during the~     36 hour study period and for 36 hours of free living during weekday.~   "
190207|NCT01074788|"~     The main goal of geriatric rehabilitation following an acute illness is rapid restoration of~     normal activity. The key elements are pain control, restoration of bowel functions, good~     sleep quality, appetite and general well-being, as well as return to pre illness physical~     capabilities. Emphasis has recently been placed on finding innovative multi-disciplinary~     methods that can improve the care of elderly people who had suffered an acute illness. The~     aim of this prospective study is to assess the effect of mind-body therapy(including guided~     imagery, relaxation techniques, mediation and touch therapy) as as an adjunct to medical and~     physical rehabilitation in geriatric patients.~   "
190208|NCT01074775|"~     The approach we will use is to employ measurement of the activation of white blood cells, to~     look at patterns of responses during a controlled infection of the gut with Mycobacterium~     bovis. M. bovis can be conveniently obtained in a safe and pure form as an oral vaccine. By~     giving three challenges of M bovis to the gut, we will simulate repeated gut infections with~     this organism. We can then compare the activation of cells in the blood to the immune~     responses seen after each challenge, to determine whether the non-specific defences of the~     gut can block each subsequent infection.~   "
190209|NCT01074762|"~     The aims of a concluding 14-year follow-up study are:~        -  To investigate what long-term effect the project model for structured, personalized~          diabetes care has on 1) the patients' mortality and development of diabetic~          complications, 2) the patients' use of services from the primary and secondary sector,~          3) the patients' self-rated health and motivation, and 4) the doctor-patient~          relationship.~   "
190210|NCT01074749|"~     The aim of the study is the comparison of two different leads in their capabilities to detect~     episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT),~     and the rejection of far field sensing of the far field R-wave (FFRW).~   "
190211|NCT01074736|"~     The identification and characterization of susceptibility loci for H5N1 infection in humans~     could have profound implications. The detection of host genetic factors may shed light on key~     pathogenic interactions between H5N1 and human cells, assisting in identifying the viral~     characteristics determining pandemic potential. In addition, the identification and~     verification of susceptibility loci would be followed by functional studies which might point~     the way to new therapeutic and preventive options.~      The objective of this study is to investigate if host genetic factors are associated with~     susceptibility to influenza H5N1 illness~   "
190212|NCT01074723|"~     We, the investigators, aim to study, in vitro and in vivo, the bioavailability of added~     b-cryptoxanthin and phytosterols and evaluate in vivo its effect on biochemical markers of~     bone remodelling and cardiovascular risk. Specifically, we will 1) assess the stability in~     the food and the bioavailability of b-cryptoxanthin in the presence of phytosterols~     (absorption modifiers) by using a complementary approach; in vitro and in vivo studies; and~     2) we will study in post-menopausal women (target group) the biological effect (bioefficacy)~     associated with the regular consumption of modified milk-based fruit beverages (containing~     b-cryptoxanthin and phytosterols) by assessing changes in biochemical markers of bone~     turnover and cardiovascular risk.~   "
190213|NCT01074710|"~     The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK)~     profile of C13-URA in healthy volunteers~   "
190214|NCT01074697|"~     GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group~     study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist~     (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting)~     control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer~     diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy.~      The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug~     regimen (standard treatment) in preventing nausea and vomiting in patients receiving~     radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of~     patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and~     it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase~     the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.~   "
190215|NCT01074684|"~     The purpose of this study is to describe the correlation between the cytohistology exam of~     patients undergoing thyroid surgery, and the predictive values of: suspicious clinical~     findings, preoperative thyroid imaging, and the incidence of thyroid cancer in cytologically~     negative nodes.~   "
190216|NCT01074671|"~     The primary goal of the study is to document the number of patients that are successfully~     implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.~   "
190217|NCT01074658|"~     The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic~     CoreValve System in a Real-World patient population.~   "
190263|NCT01074060|"~     RATIONALE: There are different methods of stem cell mobilization, such as using~     colony-stimulating factors alone or following chemotherapy priming. More recently, the~     combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell~     mobilization. This study will assess whether the combination of plerixafor and Granulocyte~     Colony-Stimulating Factor (G-CSF) is effective following chemotherapy mobilization with~     cyclophosphamide.~      PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor~     following cyclophosphamide priming.~   "
190218|NCT01074645|"~     Background: Reactivation of hepatitis B is a well-characterized syndrome marked by the abrupt~     reappearance or rise of hepatitis B virus (HBV) DNA in the serum of a patient with previously~     inactive or resolved HBV infection. Reactivation can be spontaneous, but is most commonly~     triggered by cancer chemotherapy, immune suppression, or alteration in immune function.~     Spontaneous acute exacerbation of chronic hepatitis B infection is seen with a cumulative~     probability of 15±37% after 4 years of follow-up.2 Significant number of patients of~     spontaneous acute exacerbation of chronic hepatitis B may present with very high ALT levels,~     jaundice and liver failure.3 This condition should be defined as acute-on-chronic liver~     failure (ACLF) according to a recent Asia-Pacific consensus recommendation.~      The short term prognosis of patients of spontaneous acute exacerbation of chronic hepatitis B~     leading to ACLF like presentation is extremely poor, with a mortality of 30-70% in different~     series.8,9,10 Liver transplantation has been the only definitive therapy available to salvage~     this group of patients. However ,this is not readily available and affordable. Another~     therapeutic option is antiviral therapy but has limited data. The efficacy of lamivudine was~     evaluated and compared by historical control but was not found to be beneficial.8,9,10~     However ,a study from Taiwan showed a survival benefit in a subgroup of patients who were on~     lamivudine and had baseline bilirubin below 342 mmol/L (20 mg/dL).11 Tenofovir disoproxil~     fumarate (TDF) is a potent, rapidly acting, oral acyclic nucleotide analogue, reverse~     transcriptase inhibitor that has been shown to be highly effective in suppressing hepatitis B~     virus replication.12 Tenofovir has also shown excellent activity against HBV in both LAM-~     naïve and LAM-resistant patients.13,14. Its efficacy has not been evaluated in patients of~     reactivation of hepatitis B who present as ACLF Hypothesis: The investigators hypothesis that~     Tenofovir reduces the morbidity and mortality in patients with Spontaneous reactivation of~     hepatitis B by reducing HBV DNA.~   "
190219|NCT01074632|"~     The objective of this study is to evaluate the effect of calorie and fat content on the~     pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder,~     or schizophreniform disorder.~   "
190220|NCT01074619|"~     The purpose of this study is to determine if memantine is effective in the treatment on~     cognitive disorders of Relapsing - Remitting multiple sclerosis. m~   "
190221|NCT01074606|"~     The objective of this study is to evaluate the postoperative visual function of Taiwanese~     patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.~   "
190222|NCT01074593|"~     The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic~     effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN~     Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy~     subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of~     2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics).~   "
190223|NCT01074580|"~     The purpose of this study is investigate if high frequency sonography and contrast enhanced~     sonography can be used to predict remission in patients with deterioration of Crohn's disease~     treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.~   "
190224|NCT01074567|"~     The purpose of this study is to examine the efficacy of dimethylsulphoxide (DMSO) cocktail in~     patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6~     weeks, 3, 6 and 12 month).~   "
190225|NCT01074554|"~     Growing research from independent laboratories provide an association between mycobacteria~     and sarcoidosis. More recent immunologic and molecular studies demonstrate immune responses~     to mycobacteria virulence factors. The purpose of this study is to assess if administration~     of anti-mycobacterial drug therapy will aid in resolution of cutaneous sarcoidosis lesions.~   "
190226|NCT01074541|"~     The purpose of the study is to determine the importance of the UV intensity and the UVB dose~     on the Vitamin D response after UVB.~   "
190227|NCT01074528|"~     The main purpose of this study is to evaluate the effects of the Mindfulness Based Stress~     Reduction (MBSR) training program that is offered in the investigator hospital, more~     specifically on quality of life, coping strategies and partner relationship by using~     questionnaires. To asses the possible impact of this treatment on the latter domain, partners~     of the patients with a cancer diagnosis are invited to join the training program.~   "
190228|NCT01074515|"~     The goal of the study is to look at how genes and certain chemicals in the body are related~     to depression and chronic obstructive pulmonary disease.~   "
190229|NCT01074502|"~     Acne is a chronic inflammatory disease of the pilosebaceous unit that affects 80-90% of the~     population, especially teenagers, although adult acne is a significant problem for 3-6 % of~     adult men and 5-12% of adult women. Although acne is not a life-threatening disease, it~     produces significant psychological disturbances and permanent skin scars.~      A novel anti-inflammatory, not antibiotic drug may be an excellent alternative for the~     treatment of moderate to severe acne. Apremilast has been shown to inhibit the production of~     tumor necrosis factor (TNF)-alpha, IL-8 and neutrophil infiltration, all of which are~     elevated in inflammatory acne.~      Our intention is to study Apremilast in the treatment of moderate to severe acne.~   "
190230|NCT01074489|"~     The purpose of this research study is to compare 3 methods of measuring blood glucose (blood~     sugar) levels to see if the finger-stick method or the continuous glucose monitoring system~     is better than or as good as the 3 hour glucose tolerance test (GTT) for the diagnosis of~     gestational diabetes.~   "
190231|NCT01074476|"~     Osteoarthritis (OA) is the most common joint disease associated with aging. Although many~     patients take glucosamine supplements as a non-traditional treatment for osteoarthritis, the~     effectiveness of these supplements is questionable. This study will evaluate glucosamine~     therapy by directly analyzing two functions of joint fluid that are impaired by~     osteoarthritis - namely, the abilities to lubricate the joint and absorb shocks during~     activity. Joint fluid samples will be collected from subjects with knee osteoarthritis and~     analyzed on a device that simulates typical joint movements. After 3 months of glucosamine~     supplementation, samples will be collected again to detect potential improvements in joint~     fluid function.~   "
190232|NCT01074463|"~     The object of this study was to compare the relative bioavailability (rate and extent of~     absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with~     that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc.~     following a single oral dose in healthy adults under non-fasting conditions.~   "
190233|NCT01074450|"~     The object of this study was to compare the relative bioavailability (rate and extent of~     absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with~     that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc.~     following a single oral dose in healthy adults under fasting conditions.~   "
190264|NCT01074047|"~     The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional~     care regimens on overall survival in elderly AML patients.~   "
190265|NCT01074034|"~     Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.~   "
190236|NCT01074411|"~     This phase I trial studies the side effects and best dose of intraperitoneal bortezomib when~     given together with intraperitoneal carboplatin in treating patients with ovarian epithelial~     cancer, fallopian tube cancer, or primary peritoneal cancer that is persistent or has come~     back. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Bortezomib may help carboplatin work better by making~     tumor cells more sensitive to the drug. Infusing bortezomib and carboplatin directly into the~     abdomen (intraperitoneal) may kill more tumor cells.~   "
190237|NCT01074398|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how well patients will respond~     to treatment.~      PURPOSE: This research study is looking at biomarkers in predicting response in patients with~     advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.~   "
190238|NCT01074385|"~     The purpose of this study is to try and improve the way that patients with colon cancer~     understand and cope with their illness and give them tools for talking with their loved ones~     and family about their illness.~   "
190239|NCT01074372|"~     This study will test the safety and tolerability (how the body reacts to the drug) of REGN727~     compared with placebo (an inactive substance that contains no medicine) in healthy subjects.~     The study drug and placebo will be administered by an injection under the skin at one clinic~     visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be~     monitored by the study staff for side effects and the body's response to the study drug.~     Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, and~     blood and urine samples will be collected at some or all visits.~   "
190240|NCT01074359|"~     This is a phase 2a, double-blind, placebo-controlled, single-center study. Twenty-one~     patients who qualify for the study will be randomly assigned to either active drug or~     placebo. The study will take place at Newcastle University. Patients will have a 66% chance~     of getting active drug. Patients will be required to take study treatment orally twice a day~     for 28 days. A baseline visit will occur within 21 days of screening visit. All patients will~     be followed for 1 week after completion of study or early withdrawal from the study.~   "
190241|NCT01074346|"~     This is an observational study to assess the tolerability of Rebif treatment in Korean~     multiple sclerosis (MS) subjects.~   "
190242|NCT01074333|"~     This is an observational, non-interventional, uncontrolled, multicentric safety study in~     subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat~     sarcoma viral oncogene homolog (KRAS) wild-type mCRC. The study aims to collect safety data~     related to Erbitux treatment from a total of at least 400 mCRC subjects from about 35~     institutions from the start of treatment with Erbitux until progressive disease,~     Erbitux-related intolerable toxicities, death, or withdrawal of Erbitux treatment (whichever~     occurs first).~   "
190243|NCT01074320|"~     Current guidelines recommend endocrine treatment with aromatase inhibitors (AIs) in~     post-menopausal women with hormone receptor-positive breast cancer. Musculoskeletal symptoms~     are commonly reported with AI treatment,however, we do not have consistent methods to measure~     these symptoms prospectively. This gap in our knowledge inhibits the ability to test and~     develop treatments for AI-associated musculoskeletal symptoms. This pilot study will evaluate~     functional tests and standardized instruments for their ability to prospectively assess~     musculoskeletal symptoms in women being treated with AIs for breast cancer.~   "
190244|NCT01074307|"~     This is a prospective, open-labeled, multi-centric trial to evaluate the effect of bisoprolol~     (between low dose and high dose) on surrogate markers of heart failure in Korea.~   "
190245|NCT01074294|"~     This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in~     adults with Attention Deficit Hyperactivity Disorder (ADHD) when taken with an approved~     stimulant medication to explore a possible impact on sleep, quality of life and cognitive~     function.~   "
190246|NCT01074281|"~     This non interventional, multicentric, uncontrolled, prospective, observational study was~     planned to observe the course of disease in subjects with ISH, who were treated with Eneas.~   "
190247|NCT01074268|"~     This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to~     compare the efficacy, safety and tolerability of NN1250 (insulin degludec ([Deg]) with~     insulin detemir (IDet), both combined with insulin aspart.~      The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension~     period is registered as NN1250-3725.~   "
190248|NCT01074255|"~     This survey is conducted for preparing application materials for re-examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the~     clinical usefulness of EMEMD (aprepitant) through collecting the safety information according~     to the Re-examination Regulation for New Drugs.~   "
190249|NCT01074242|"~     This survey is conducted for preparing application materials for re-examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the~     clinical usefulness of Rotateq through collecting the safety information according to the~     Re-examination Regulation for New Drugs.~   "
190259|NCT01074112|"~     The study is based on the premise that ultrasound is not commonly used in an ambulance. There~     are some departments that do deploy it into the field, but of those departments there is~     almost no data collected about its use. Currently Paramedics are not recognized by insurance~     companies as health care providers capable of performing ultrasound. If there were more data~     on the subject that may eventually change. We are hoping to prove that not only is ultrasound~     useful in an ambulance, but that paramedics are good at interpreting the results. We will~     save images, the paramedic's diagnosis and some basic information about the call. We will not~     save any protected health information (PHI) or any information linking the subject to the~     study. The data collected will be sent to a non-biased ultrasound reviewer to grade the~     images for the accuracy of diagnosis and the quality of the view obtained. This data will be~     used to formulate a report and statistics on paramedic's ability to perform ultrasound in the~     field.~   "
190260|NCT01074099|"~     Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2~     centrifuge and have the concentrated nucleated cells injected into areas of ischemic~     myocardium~   "
190250|NCT01074229|"~     The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior~     -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and~     the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of~     local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse~     abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal~     wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was~     first described by McDonnell et al. as a landmark technique to provide analgesia for lower~     abdominal surgery.~      Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which~     they named posterior TAP block. The ultrasound allows identification of the external oblique~     abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional~     anesthetic techniques suggest improved block quality and safety, which is primarily due to~     direct visualization of the relevant anatomy, the tip of the needle, and the spread of the~     local anesthetics.~      Clinical trials of the single shot posterior TAP block have shown a significant reduction in~     morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly~     et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic~     cholecystectomy reduced perioperative opioid consumption by more than 50%.~      This is the first study to evaluate the effect of TAP block in the quality of recovery in~     patients undergoing laparoscopic hysterectomy and may help the pathway to make this an~     outpatient procedure.~   "
190251|NCT01074216|"~     The purpose of this study is to find out what effects, good and/or bad, vitamin D blood~     levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to~     increase low vitamin D levels into normal range using vitamin D supplements taken by mouth.~     Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low~     vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if~     increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely~     repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given~     would be considered standard of care.~   "
190252|NCT01074203|"~     Recurrence of Hepatitis C virus infection (HCV) is universal after orthotopic liver~     transplantation (LTx) and is associated with allograft failure, death and need for~     re-transplantation. Currently, there are no effective therapies to prevent HCV recurrence.~     Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and~     effective in achieving sustained viral response in patients with chronic HCV genotype 4. Its~     role in the prevention of HCV recurrence after liver transplantation has not been studied.~     The investigators propose to conduct an open label pilot study examining the role of NTZ in~     the prevention of HCV re-infection in eight patients undergoing LTx. First time transplant~     recipients for chronic HCV without history of renal failure or HIV/HBV co-infection, will~     receive NTZ immediately prior to LTx and for 3 days thereafter. The primary endpoint is the~     number of patients who remain HCV-RNA-negative at day 7 after LTx. If at least one patient~     remains negative, the study will be determined to be positive. Additionally, the~     investigators will examine the viral kinetics of HCV, tolerability and safety of NTZ.~   "
190253|NCT01074190|"~     A previous randomized trial showed a possible negative association with labor neuraxial~     analgesia with high compared to low doses of fentanyl, and breastfeeding at 6 weeks~     postpartum. The significance of this study would be to validate or refute these findings. In~     addition, we hope to better evaluate the impact of cumulative dose of fentanyl on~     breastfeeding success in the initial postpartum period as well as at 6 weeks and 6 months~     post delivery. In order to better assess the quality of breastfeeding, we will utilize a~     validated breastfeeding assessment tool, LATCH (Latch, Audible swallowing, Type of Nipple,~     Comfort, and Help). This validated tool can assess maternal and infant variables, define~     areas of needed intervention, and determine priorities in providing patient teaching. The~     LATCH assessment has been shown to be a predictor of breastfeeding duration. We also plan to~     vary the dosage of fentanyl analgesia to determine the relationship between doses below 150~     micrograms and changes in breastfeeding assessments. If a clear association between decreased~     breastfeeding and total fentanyl is identified, then regimens to reduce cumulative doses of~     fentanyl can be developed to improve the likelihood of breastfeeding success in mothers that~     desire to breastfeed.~      Prior observational studies have inferred epidurals negatively affect breastfeeding by~     decreasing maternal plasma oxytocin release which may adversely affect infant neurobehavioral~     development. In a study by Beilin et al., it was reported that mothers receiving a high~     cumulative dose (> 150 microgram) epidural fentanyl were more likely to have stopped nursing~     6 weeks postpartum compared with groups receiving no fentanyl or those receiving < 150~     microgram. The study however, was underpowered to detect differences in breastfeeding prior~     to hospital discharge. In addition, the breastfeeding assessment tool utilized resulted in~     binary assessments, and therefore, a global rating of the quality of breastfeeding was not~     available.~   "
190254|NCT01074177|"~     In this research study we are looking to see how effective BIBW 2992 is at suppressing the~     development of the T790M mutation in non-small cell lung cancer (NSCLC) patients. Epidermal~     growth factor receptors (EGFR) are proteins found on the surface of some cancer cells that~     promote a growth signal. Some cancer drugs for NSCLC work to block this signal from reaching~     its target on the cancer cells which in turn may slow or stop the cancer from growing.~     However, many times patients with EGFR mutations will stop responding to these cancer drugs~     and develop drug-resistance because they have developed a specific EGFR mutation called~     T790M. BIBW 2992 may prevent the T790M mutation from becoming active and therefore slow~     disease progression.~   "
190255|NCT01074164|"~     The purpose of this study is to see if acupressure will be effective at reducing itch in~     people with atopic dermatitis (AD).~   "
190256|NCT01074151|"~     The Cymbalta Pregnancy Registry is a U.S. based Registry designed to monitor women who are~     exposed to Cymbalta (duloxetine) during pregnancy. This is an observational,~     exposure-registration and follow-up registry.~   "
190257|NCT01074138|"~     The standard of care for patients with bone-metastatic, castrate-resistant prostate cancer is~     chemotherapy. If a patient elects not to choose chemotherapy, 70% will progress within 6~     months. KX2-391 given orally twice a day for 6 months will be evaluated for its ability to~     delay/prevent disease progression in patients who have not had prior chemotherapy.~   "
190258|NCT01074125|"~     This is a research study for people with high blood phosphorus levels who are on dialysis.~     This medical condition can cause weakening of the bones and damage other organs. This can~     lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat,~     and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid~     of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often~     patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood~     phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric~     citrate) is safe and effective as a phosphate binder.~   "
196544|NCT00990743|"~     The purpose of this study is to determine whether SYL040012 is safe for the treatment of~     ocular hypertension and glaucoma.~   "
190266|NCT01074021|"~     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical~     trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has~     been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and~     nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult~     with head and neck cancer. The study assessed the clinical efficacy, and safety of the~     combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in~     patients with advanced nasopharyngeal cancer.~   "
190267|NCT01074008|"~     This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of~     multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072~     in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.~   "
190268|NCT01073995|"~     The median Orthopaedic surgery wait time in Canada is 36.7 weeks (Esmail 2008), thus there is~     a need to find alternative treatments for pathologies such as lumbar disc herniations (LDH).~     The literature has demonstrated that selective nerve root injections (SNRI) are able to~     alleviate sciatic symptoms caused by LDH (Riew 2006) and may be beneficial as an alternative~     to surgery. It is necessary to determine whether SNRIs provide significant symptom resolution~     alleviating the need for surgery, or to determine if their success is transient and delays~     the time to surgery. The purpose of the proposed study is to evaluate the success of SNRI in~     patients suffering with LDH and to determine which factors influence outcome. Over the span~     of 2 years, data from 100 patients will be collected. These patients will be surgical~     candidates and have exhausted all non-operative measures prior to receiving a SNRI. Upon~     first assessment, each eligible patient will be randomly assigned to the treatment (steroid)~     or control (saline) group. The patient and all treating physicians will be blinded to the~     treatment given. Each patient will be followed over their course of treatment and information~     pertaining to their pain and symptoms will be recorded using standard questionnaires. Patient~     demographics, diagnosis, Worker's Compensation status, spinal levels treatment/outcome, and~     time from referral to treatment will also be evaluated. The primary outcome measure will be~     defined as the avoidance of surgery.~   "
190269|NCT01073982|"~     The purpose of this study is to assess the effects of tart cherry juice to reduce pain and~     inflammation among individuals with arthritis.~   "
190270|NCT01073969|"~     The primary objective of this trial is to determine whether two doses of an extract from bran~     demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial~     populations, particularly bifidobacteria). The secondary objective is to measure the~     potential beneficial effects of consuming an extract from bran on the following physiological~     parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and~     insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial~     short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers~     of oxidative stress and inflammation.~   "
190271|NCT01073956|"~     The purpose of this study is to determine the efficacy of electrotherapy as a coadjuvant in~     mobility and exercise treatment in the reduction of pain intensity in subacromial impingement~     syndrome.~   "
190272|NCT01073943|"~     Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep:~     2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet)~     and 6 hours later in the evening (second dose - sachet), given the day before the procedure~     or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the~     procedure to evaluate its effectiveness, tolerability and safety.~   "
190273|NCT01073930|"~     Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep:~     2-sachets for oral solution in two divided doses given a night before (first dose - sachet)~     and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral~     solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its~     effectiveness, tolerability and safety.~   "
190274|NCT01073917|"~     Atelectasis and redistribution of ventilation towards non-dependent lung zones are a common~     side effects of general anesthesia. Spontaneous breathing activity (SBA) during mechanical~     ventilation may avoid or reduce atelectasis, improving arterial oxygenation; however, it is~     unclear whether these effects play a significant role during general anesthesia in patients~     with healthy lungs. Earlier studies on ventilation during general anesthesia had to rely on~     computed tomography (CT) findings. Recent advances in lung imaging technology allow to assess~     the regional aeration of the lungs continuously and non-invasive by electrical impedance~     technology (EIT). In this work, we will use the EIT to assess ventilation changes from the~     time before induction of anesthesia until discharge from the post-anesthesia care unit. Our~     main focus is the difference caused by pure positive pressure ventilation (PCV) and assisted~     spontaneous breathing (pressure support ventilation, PSV). Our findings would improve our~     understanding of the physiology of the lungs during general anesthesia and would help to~     improve the standards of respiratory care during anesthesia~   "
190275|NCT01073904|"~     A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover,~     randomized, prospective design was chosen with a washout of 14 days between the two study~     periods. Treatment groups are balanced with the same number of male healthy volunteers who~     were randomly assigned to the study drug administration sequences.~   "
190276|NCT01073891|"~     The purpose of this study is to describe the pharmacokinetics of a new oral liquid~     moxifloxacin formulation and the influence of concommitant food intake on the~     pharmacokinetics in healthy adults compared to the marketed oral tablet. Pharmacokinetics is~     to see how the body absorbs, distributes and gets rid of the study drug. The absorption of~     the drug administered in a different dosage form may be altered due to the influence of~     different excipients used. The safety of moxifloxacin when administered as an oral liquid~     formulation will also be looked at. Results from this study will be used to guide dosing~     strategies of the larger clinical trial planned for children.~   "
190277|NCT01073878|"~     The purpose of this study is to determine if the Athena Pelvic Muscle Trainer device~     effectively treats stress, urge or mixed incontinence in women by strengthening the pelvic~     floor muscles by collecting data from the patient on the~        1. Over Active Bladder Questionnaire~        2. The 7-Day Urine Diary questionnaire~           This study will also look at whether or not there is an improvement in sexual health~          after using the device by collecting data frm the patient on the~        3. Female Sexual Function Index questionnaire~   "
190279|NCT01073852|"~     This study is for those people with difficult to treat hives. We are investigating whether or~     not a different medication, hydroxychloroquine, works to treat a certain type of hives.~     Hydrochloroquine is currently approved by the Food and Drug Administration (FDA), for~     treating arthritis, therefore it is considered investigational in this study.~      Hypothesis: Hydroxychloroquine will prove to have an efficacious response in terms of~     Urticarial Symptoms, on patients with chronic urticaria.~   "
190280|NCT01073839|"~     OBJECTIVES~      Primary objective:~      The primary objective of the trial is to determine the safety of adjuvant treatment with~     cisplatin plus gemcitabine for a period of 6 months after curative resection of~     cholangiocellular carcinoma~      Secondary objectives:~      Secondary objectives of the trial are to assess the feasibility and efficacy of the adjuvant~     therapy and to determine duration of response and patterns of failure compared to historical~     controls without postoperative treatment~      Exploratory objectives:~      To obtain blood samples and tumor tissue after resection for establishment and~     characterization of new cholangiocarcinoma cell lines and tumor antigens. Other aims are~     identification of tumor specific antibodies from blood samples, and characterization of tumor~     antigens with consecutive development of new specific immunological therapies, e.g.~     cancer-testis antigens (CTA) for tumor vaccination.~        -  Trial with medicinal product~   "
190281|NCT01073826|"~     The purpose of the study is to understand the role of interleukin-6 during physical activity~     in patients with type 2 diabetes.~   "
190282|NCT01073813|"~     The primary aim of this open-label pilot trial is to estimate the treatment effect of 100 mg~     of oral minocycline twice daily for 90 days, initiated within 30 days of onset of ON, on~     functional and structural optic nerve recovery compared to no treatment. The primary outcome~     measure that will be used to measure optic nerve recovery is retinal nerve fibre layer (RNFL)~     thickness. Other objectives: Secondary outcomes are temporal RNFL thickness, macular volume,~     and visual outcomes.~   "
190283|NCT01073800|"~     Patients are admitted to the critical care unit of the hospital because of medical conditions~     that have a high likelihood of causing severe problems with blood flow, breathing, or brain~     function. These conditions also have a high likelihood of causing death. Approximately 10 to~     15% of all critically ill patients die in hospital. A large amount of scientific evidence~     suggests that a substantial proportion of these deaths is due to a combination of blot~     clotting and inflammation in the blood vessels.~      Statins are drugs that interfere with cholesterol and fat metabolism. Cholesterol and fat in~     the blood are associated with blood clotting and inflammation in the blood vessels. Statins~     are known to be very beneficial in improving the survival after heart attacks, and in~     preventing heart attacks.~      The question that VASTVALUS asks is: do statins improve survival among all critically ill~     patients? In VASTVALUS, we will concentrate on patients that do not currently require a~     statin because of their medical condition e.g. after a heart attack, but we are concerned~     with the rest of the critically ill. In VASTVALUS, participating patients will receive either~     atorvastatin 80 mg daily or a placebo. Atorvastatin is a statin with a well-established~     record of safety and effectiveness. A placebo has no known medical activity. We will follow~     all patients in VASTVALUS to determine whether atorvastatin has any effect on the occurrence~     of death, stroke, heart attack, or kidney failure among the critically ill. Results from~     VASTVALUS will be shared with the medical community after the study is completed. As with all~     clinical trials, patients in VASTVALUS participate of their own choice, and can change their~     mind at any time.~   "
190284|NCT01073787|"~     The purpose of this study is to evaluate the effect of intravenous fluid (0.9% sodium~     chloride and water) alone on headache pain in children with migraine visiting the Emergency~     Department.~   "
190285|NCT01073774|"~     The diagnosis and treatment of cancer leads to emotional distress, and major disruptions in~     role functioning. Traditionally, psychosocial services offer individuals diagnosed with~     cancer peer group support or individual counseling with only few consideration of type or~     stage of cancer. Besides most cancers significantly impacting not only the individual but~     also their partners and families, breast and gynecological cancer may be particularly~     embedded in an interpersonal context, namely in the couple's relationship. Breast and~     gynecological cancer cause additional concerns about the women' body image, sexual~     functioning and these cancers may be prone to provoke or enhance maladaptive patterns of~     interaction between women and their partners. Thus, not only the individual but also the~     couple's functioning is threatened by these diagnoses.~      The aim of the here proposed study is to identify predictors of couple's adjustment and to~     help couples to improve their ability to support each other during this time. In a multi-site~     study, we will evaluate the efficacy of a couple-based intervention entitled Side by Side:~     Coping with Cancer Together (Seite an Seite: Krebs Gemeinsam Bewältigen). The intervention~     teaches couples relationship skills that have been repeatedly validated within the marital~     field. The aim of the intervention is to improve couples' skills to talk to each other~     effectively about cancer-related topics, and enhance (or maintain) an affectionate~     relationship in the face of death.~      We will randomly assign 303 women recently diagnosed with either breast or gynecological~     cancer and their partners to one of two conditions: (1) Seite an Seite, or (2)~     Treatment-As-Usual, in which couples receive no active psychosocial intervention. Assessment~     will be conducted pre-, post-, and at 6 and 12 months follow-up. These assessments include~     for both partners negative and positive self-report measures of individual functioning (such~     as mood, anxiety and benefit finding) and relationship functioning (such as relationship~     distress, communication patterns). Furthermore, at pre-, post- and 12-month Follow-up~     observational data on mutual supportive behavior when communicating about a cancer-related~     topic will be collected. The study may enhance our understanding of the significance of~     relationship skills in the process of adjusting to cancer as a couple and as an individual.~   "
190286|NCT01073761|"~     The purpose of the study is to look at the levels of three HIV medications darunavir,~     ritonavir and atazanavir in the blood after the drug intake has been stopped in order to~     understand how long these drugs persist in blood for. The study will specifically look at~     these three drugs blood levels after taking them for 10 days everyday.~      The main objective is to provide information on the potential safety (in terms of preventing~     virological failure and the development of resistance)of delaying drug doses occasionally by~     providing information on the decline in drug concentration after dosing has stopped.~   "
190287|NCT01073748|"~     Asthma is a common inflammatory airway disease. Several researches have demonstrated a~     possible connection between asthma and exposure to paracetamol.~      Our hypothesis is that even a single dose of paracetamol is sufficient to cause a measurable~     change in lung functions.~      This trial aims to identify a possible effect of single dose paracetamol on lower airway~     function.~   "
190288|NCT01073735|"~     This feasibility study will determine the psychometric adequacy of a newly developed~     instrument - Childhood Cancer Survivor Study Needs Assessment Questionnaire (CCSS-NAQ).~     Additionally, the study will explore the feasibility of selected study methods -- sample~     selection, length of time to complete recruitment, and response rates - in order to inform a~     larger national periodic survey of adult survivors' health related needs~   "
190289|NCT01073722|"~     Lung isolation is used to achieve one lung ventilation to facilitate thoracic surgery. Two~     methods are commonly used, a double lumen tube (DLT) or a bronchial blocker introduced~     through a single lumen tube. However, both techniques have advantages and disadvantages.~     Briefly, the DLT can be positioned faster and remains firmly in place, but is sometimes~     difficult or even impossible to introduce. The DLT is larger than a conventional single lumen~     tube and the incidence of postoperative hoarseness and airway injuries is higher. Compared to~     the DLT, bronchial blocking devices are more difficult to position and need more frequent~     intraoperative repositioning. These disadvantages of the existing devices for lung isolation~     prompted further development of the bronchial blocker concept. The design of a new Y shaped~     bronchial blocker, the EZ- Blocker® (AnaesthetIQ BV, Rotterdam, The Netherlands) (EZB),~     combines the advantages of both lung isolation techniques. The aim of the study is to compare~     in a randomised, prospective way the ease of placement, the incidence of malpositioning and~     the quality of lung deflation of a left DLT and a EZB. Secondly, the incidence and severity~     of damage to laryngeal, tracheal and bronchial structures caused by the use of the DLT or the~     EZB is a target of the study.~   "
190290|NCT01073709|"~     The study was conducted as an open labeled, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioavailability study comparing acetaminophen extended~     release gelcaps 650 mg of OHM Laboratories Inc. with Tylenol® Arthritis Pain caplets 650 mg~     of McNeil Consumer & Specialty Pharmaceuticals, in healthy, adult, human, male subjects under~     fasting condition.~   "
190291|NCT01073696|"~     The purpose of this study is to determine the effect of heat applied to a granisetron~     transdermal patch in healthy subjects.~   "
190292|NCT01073683|"~     Treatment of patients with one cycle of induction chemotherapy to select for organ~     preservation of the larynx has been proven as a standard approach. When compared to~     historical controls. The investigators propose to study patients with a similar treatment~     strategy (i.e. one cycle of induction chemotherapy followed by two more chemotherapy cycles,~     in advanced nodal disease, followed by chemoradiation for those responding to the initial~     chemotherapy. Those who fail to respond or fail in radiation will directly undergo surgery.~     The novelty of the proposed study is that non responders and failures will be given the~     opportunity of larynx preserving supracricoid laryngectomy. The investigators will attempt to~     reduce toxicity from induction chemotherapy and improve potency with the use of~     docetaxel/cisplatin/5-fluorouracil (TPF) in place of the standard regimen of cisplatin and~     5-fluorouracil (PF). Emerging data demonstrates that induction regimens containing triplets~     with platinum, 5-fluorouracil, and taxanes produce higher response rates and less overall~     toxicity when compared to induction strategies utilizing PF~   "
190293|NCT01073670|"~     Following signed informed consent, patients scheduled for elective cardiac surgery were~     randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination~     of both immediately following induction and then at 6, 12, 18 & 24 hours following surgery.~     Our primary outcome measure was the amount of blood drained from the mediastinal tubes and~     chest drains. Secondary outcome measures included conventional blood coagulation indices as~     well as other measures of clotting as indicated by thromboelastography (TEG). Other secondary~     outcome measures included consumption of morphine equivalents and pain scores.~   "
190294|NCT01073657|"~     The goal of this project is to gather data necessary for a full scale trial of a supported~     education service for OIF/OEF veterans with PTSD. Forty Veterans with PTSD will be randomly~     assigned to an intervention group (N=20) that receives a weekly supported education~     intervention and a control group that receives services as usual plus an hour of attentive~     intervention not focused on education. We will assess and compare the number of hours of~     participation in community education settings and on acquiring an educational goal for the~     Veterans in each group.~   "
190295|NCT01073644|"~     The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib~     malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal~     stromal tumor among filipino patients in usual clinical practice setting.~   "
190296|NCT01073631|"~     This is a non-interventional study of voriconazole tablet in Korea which is mandated by the~     Korean government agency.~   "
190297|NCT01073618|"~     This is non-interventional study of voriconazole IV formulation in clinical use, which was~     mandated by the Korean government agency following the approval of Vfend in the Republic of~     Korea.~   "
190298|NCT01073605|"~     To evaluate the effect of continuous and intermittent administration of Genotonorm on stature~     in short prepubertal children with intra-uterine growth retardation~   "
190299|NCT01073592|"~     The Foresee Home is used in the recent years to detect age-related macular degeneration (AMD)~     lesions. The device is capable of differentiation as to stages of AMD and early detection of~     changes including choroidal neovascularization (CNV). The Foresee Home demonstrates a high~     level of sensitivity and specificity as to the different stages of AMD including newly~     diagnosed or early detection of CNV.~      The OCT may be use as well to identify choroidal neovascularization (CNV). Comparison between~     the two methods will allow better understanding of both devices.~      The Foresee Home can use as an assessment tool for the progression and success of the~     treatment given to AMD lesions. Therefore, evaluation the size and the location of the~     treated lesions may serve as an additional tool.~   "
190300|NCT01073579|"~     The purpose of this study is to create a patient registry to collect and analyze information~     on subjects treated with Sabril and the prescribers of Sabril.~   "
190301|NCT01073566|"~     The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when~     used in conjunction with basal insulin, achieves equivalent glycemic control when compared to~     multiple daily injections and to evaluate its preference.~   "
190302|NCT01073553|"~     A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over~     design was used with a washout of 7 days between the two study periods. Treatment groups~     balanced with the same number of healthy volunteers who were randomly (in two strata: male~     and female) assigned to the study drug administration sequences.~   "
190303|NCT01073540|"~     A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over~     design was used with a washout of 7 days between the two study periods. Treatment groups~     balanced with the same number of healthy volunteers who were randomly (in two strata: male~     and female) assigned to the study drug administration sequences.~   "
190304|NCT01073527|"~     To investigate the efficacy of adding Inhaled Hypertonic Saline treatment (HS) for 1-6 year~     old children with asthmatic attack presenting to Emergency Department (ED).~      Background: In 1-6 year old children, the most common causes of acute exacerbations of asthma~     requiring urgent medical care are viral respiratory infections. Most of these children are~     not atopic and often do not respond very well to bronchodilators and steroids. Thus novel~     treatments are needed.~      HS is considered an effective and safe treatment for infants with acute viral bronchiolitis~     (Cochrane 2008). HS acts in the airways in several mechanisms: HS re-hydrates secretions and~     improving mucus rheology, reduce edema of the airway wall by absorbing water from the mucosa~     and submucosa, causes sputum induction and cough, which can help to clear the sputum out of~     the bronchi, stimulates cilial beat via the release of prostaglandin E2, breaks the ionic~     bonds within the mucus gel, thereby lowering the viscosity and elasticity of the mucus~     secretion.~      It is estimated that all the above HS responding elements may play a role in this viral~     induce wheezing. The above mentioned theoretical benefits provide the rationale for the~     possible treatment of viral induced acute wheezing (asthma) attack with nebulized HS in~     young pre-school children presenting to the Pediatric Emergency Unit with acute (mostly viral~     induced) wheezing.~      Therefore, the purpose of the present study is to 1. Investigate the addition of frequently~     nebulized 5% HS/albuterol combination to standard therapy of acute asthmatic episodes~     presenting to the emergency department (ED) in preschool children in a prospective,~     randomized, double-blind, controlled fashion.~   "
190305|NCT01073514|"~     To investigate bile culture and susceptibility test in patients with malignant biliary~     obstruction (MBO) or relation between bile, portal vein or vein culture and biliary~     infection. Also to get the information of bile metabonomics to find potential tumor marker~     .Culture of the organism is recognized as the gold standard for diagnosis of infection. Our~     research may be one of the first research on culture and susceptibility test in patients with~     MBO. The results of the trial research will be benefit to experiential therapy of MBO with~     biliary infection and diagnosis of MBO.~   "
190306|NCT01073501|"~     Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or~     end-stage renal disease. Its intensity ranges from sporadic discomfort to complete~     restlessness during both the day- and night-time and its distribution varies significantly~     over time. Many attempts have been made to relieve this bothersome symptom in affected~     patients, however with generally limited success. Incidence of UP varies widely between~     studies and seems to decline over the last 30 years (from 85% in the 1970s and 50-60% in the~     1980s to a 22% in the 2000s) (Gunal AI).~      We use Pregabalin for the relief of diabetic neuropathic pain in patients on haemodialysis in~     our centre. In addition to neuropathic pain, several of our patients have complained of~     pruritus and after Pregabalin treatment, their pruritus has promptly and completely resolved.~     Accordingly, we intend to conduct a double-blind, placebo-controlled, crossover trial to~     assess the effectiveness of Pregabalin in chronic UP.~   "
190307|NCT01073488|"~     The objective of this cluster randomized controlled trial is to reduce maternal and neonatal~     mortality by increasing access to and improving the quality of obstetric and neonatal care~     for pregnant women in study clusters. It is hypothesized that a 25% reduction in >28 week or~     >1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention~     clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be~     introduced by an EmONC team.~   "
190308|NCT01073475|"~     The primary purpose of this population-based study is to quantify and understand the trends~     in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide~     population-based data on stillbirths, neonatal and maternal mortality.~   "
190309|NCT01073462|"~     The purpose of this study was to ascertain the percentage of cardiac patients with chronic~     kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid~     hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI)~     treatment guidelines (150 - 300 pg/mL) after 2 years.~   "
190310|NCT01073449|"~     This study will enroll all patients who will attend an in-hospital follow-up of cardiac~     device since February 22nd 2010 to June 21st 2010.~      Primary objective of the study is to observe how many of patients seen during these period~     (approximately 5000) will receive a change in cardiac device programming or in drug therapy~     or a scheduled or urgent hospital admission.~      These data should help to clarify how useful and safe is a remote monitoring strategy for~     this kind of patients.~   "
190311|NCT01073436|"~     To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML)~     previously treated with interferon-alpha (IFN) and presently on a tyrosine kinase inhibitor~     (TKI) (imatinib mesylate, dasatinib, or nilotinib) with achievement of a complete cytogenetic~     and at least a major molecular remission, are able to discontinue therapy and maintain a~     durable remission. Relapse-free survival (RFS) rate at 1 year after discontinuation of TKI~     will be the measurement of this objective.~   "
190312|NCT01073423|"~     The purpose of this study is to see if yoga or music therapy can improve the sleep of adults~     with HIV.~   "
190313|NCT01073410|"~     The purpose of this study is to find out the roles of two specific gene families (the~     chitinase gene family and the TGFB family). We hypothesize that chitinases and TGFb pathway~     genes will be differentially expressed in the airways of non-asthmatic subjects and subjects~     with asthma. We further hypothesize that genetic variants in CHIT1, AMCase, and TGFb pathway~     genes that show associations with asthma and related phenotypes will change the expression~     and/or function of the protein of these genes in the airway in several ways, including the~     transcript numbers for full length genes and splice variants and, for the chitinase genes,~     the levels of chitinase activity in airway secretions.~   "
190314|NCT01073397|"~     The purpose of this research study is to compare yoga and health and wellness classes for~     helping perimenopausal or newly postmenopausal women who are experiencing hot flashes. The~     investigators want to learn about the effects of yoga and health and wellness classes on~     symptoms and other quality of life issues. The results of this study may provide important~     knowledge to women and clinicians who counsel women with menopausal hot flashes.~   "
190315|NCT01073384|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of four doses of~     SGX201 in subjects with rectal cancer treated with concurrent radiation and chemotherapy.~   "
190317|NCT01073358|"~     It is uncertain, whether hilar lymphadenectomy should be performed routinely in patients~     undergoing resection of colorectal liver metastases.~      For this reason it is the aim of the present prospective randomized trial to evaluate, if~     routine lymphadenectomy reduces recurrent disease in patients undergoing resection of~     colorectal liver metastases.~   "
190318|NCT01073345|"~     The aim of this study is to investigate the pathophysiological mechanisms underlying the~     formation of posthepatectomy ascites with a focus on the significance of changes in portal~     venous hemodynamics after hepatic resection. By evaluation of other factors that may be~     involved in the formation of ascites this study may help to show to what extent the increase~     of portal venous pressure contributes to ascites formation. Detailed knowledge about~     pathogenetic factors concerning the formation of postoperative ascites might help preventing~     protracted hospital stay and further inconveniences to the patient.~   "
190319|NCT01073332|"~     Human exercise capacity decreases with aging. One explanation may be that blood vessels~     stiffen with age and release less of a compound called nitric oxide (NO). This compound~     normally relaxes blood vessels and increases blood flow to muscles, but damaging compounds~     called free radicals can interfere with this process. Antioxidants may help prevent free~     radicals from inactivating nitric oxide. The purpose of this study was to investigate the~     effects of an antioxidant supplement that supports NO production on exercise performance in~     elderly male cyclists.~   "
190320|NCT01073319|"~     To study the effects of treatment with rivastigmine on craving produced by experimental~     administration of methamphetamine.~   "
190321|NCT01073306|"~     Dengue viruses can cause dengue fever and other serious health conditions, primarily~     affecting people living in tropical regions of the world. This study will test whether a~     vaccine developed to prevent infection with dengue virus type 2 causes a response in people's~     immune system and is safe.~   "
190322|NCT01073293|"~     This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is~     well tolerated and causes a non-inferior immune response when compared to administration of~     REPEVAX™ one month following the first dose of V503.~   "
190323|NCT01073280|"~     The investigators will take cerebral and subarachnoid biopsy by flexible endoscopy in~     patients without neurological findings. The investigators will use retrospective and~     prospective patients.~   "
190324|NCT01073267|"~     The goal of this clinical research study is to learn if a lower than standard dose of total~     skin electron beam radiation therapy to the skin can help to control mycosis fungoides. The~     safety of this dose level will also be studied.~   "
190325|NCT01073241|"~     In this study, the investigators designed a randomized and double-blind prospective trial to~     evaluate the efficiency and safety of the investigators new approach—transurethral ventral~     wall of urethra-preserving enucleation of prostate in comparison with TURP for the~     hyperplasia weighing more than 45 g.~   "
190326|NCT01073228|"~     This study is being conducted to determine the safety and effect on cognitive function of the~     investigational medication, EVP-6124, in individuals with mild to moderate probable~     Alzheimer's disease.~   "
190327|NCT01073215|"~     The Primary Care Research Network for the Treatment of Adolescent Obesity will establish~     infrastructure within the primary care setting to support programmatic research on weight~     loss for underserved adolescents, primarily urban African Americans, rural Caucasians, and~     Latinos. Using primary care settings, to which many youths already have entry, may increase~     access for underserved adolescents to participate in obesity treatment and research. The~     primary project will be a 12 month randomized controlled study comparing the relative~     effectiveness of two interventions for weight reduction: Group Condition (a family based~     lifestyle modification program delivered by health care providers in 23 sessions);~     Self-Guided Condition (a family based lifestyle modification program that combines a~     self-guided, home-based approach with 6 sessions delivered by health care providers).~   "
190328|NCT01073202|"~     This study is designed to investigate the possible beneficial effects of UDCA on liver graft~     recovery early after adult liver transplantation.~   "
190329|NCT01073189|"~     Randomized prospective trial of patients with diuretic unresponsive acute kidney injury where~     patients will receive standard supportive therapy with diuretics versus intra-renal delivery~     of the vasodilator fenoldopam mesylate.~      Patients with rising creatinine who fail to respond to bolus diuretics will be treated with a~     prolonged course of diuretics or undergo placement of a catheter within the renal arteries~     that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a~     high dose vasodilator may reverse the decline of renal function in patients with severe acute~     kidney injury.~   "
190330|NCT01073176|"~     Training Executive, Attention and Motor Skills (TEAMS) is a new research program for~     preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use~     game-like activities and physical exercise to promote the growth of neural processes that~     underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as~     associated areas of difficulty (e.g., socialization, motor skills). These activities are~     implemented at home and in supervised playgroups at no cost to families and are coupled with~     extensive parental education about ADHD symptoms and associated impairments.~   "
190331|NCT01073163|"~     The primary objective of this study is to assess the effect of treatment with bendamustine on~     cardiac repolarization as reflected by the rate-corrected QT interval by the Fridericia~     method (QTcF).~   "
190332|NCT01073150|"~     The purpose of this study is to determine:~        -  The prevalence of Demodex sp. in chronic blepharitis.~        -  The efficacy of the treatment of topical Tree Tea Oil in chronic blepharitis for Demodex~          sp.~   "
190333|NCT01073137|"~     The purpose of the research is to determine whether a noninvasive hearing test may be used to~     predict blood glucose in people with diabetes.~   "
190334|NCT01073124|"~     The purpose of this study is to determine if adding blue dye improves the saline load test,~     which is a way to detect a traumatic intraarticular knee injury by injecting normal saline~     into the knee and looking for outflow through the wound.~   "
190335|NCT01073111|"~     The purpose of this study is to compare coronary endothelium function in patients with a~     zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical~     coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker~     level.~   "
190336|NCT01073098|"~     Out of hospital cardiac arrest is a major health problem. Prognosis is still poor even after~     return to spontaneous circulation. The pathophysiology of cardiac arrest implies~     ischemia-reperfusion and sepsis like syndrome. These phenomenons can lead to microvascular~     dysfunction explaining probably multi-organ failure after cardiac arrest. Few means allow the~     exploration of microvascular function in human. Muscle StO2 is a technique allowing the~     assessment of microvascular function non-invasively. The aim of this study is to evaluate~     muscle StO2 as a prognostic factor after out of hospital cardiac arrest.~   "
190337|NCT01073085|"~     The purpose of this study is to investigate the effectiveness of a French fully automated~     web-based smoking cessation program known as the coaching, by comparing it to an online~     self-help guide.~   "
190338|NCT01073072|"~     This is a multicentric prospective randomized study comparing technique of tension-free~     repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to~     current conventional surgical techniques in potentially contaminated hernia repair and~     abdominal wall reconstruction.~      The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative~     complications at 30 days in the treatment of incisional hernias or complicated abdominal wall~     hernias (ref early complications) for potentially contaminated fields.~   "
190339|NCT01073059|"~     -  This trial is conducted to assess pharmacokinetic characteristics of valproic acid when~          valproic acid single treatment and valproic acid & ertapenem combination treatment~        -  This trial is performed to evaluate safety of the combination treatment compare with~          single treatment~        -  The investigators carry this trial out to study mechanism of combination treatment~   "
190340|NCT01073046|"~     The purpose of this study is to test the utility of the nasogastric tube, which is used to~     decompress and as guardian of gastro-jejunal anastomosis, in patients undergoing distal~     subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or~     according Roux.~   "
190341|NCT01073033|"~     To assess protection against early life infections through supplementation of mothers during~     pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.~   "
190342|NCT01073020|"~     There is substantial clinical evidence regarding the safety and efficacy of currently~     practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2~     diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Evidence suggests such~     procedures have greater effects on insulin secretion and insulin action than that expected~     from weight loss alone, which has led to the recent claim that such procedures may be useful~     as a primary treatment for T2DM in the moderately obese population. Concurrently, there have~     also been substantial advances in the non-surgical medical management of T2DM. As a result,~     the best treatment algorithm for T2DM patients with class 1 & 2 obesity is increasingly~     controversial. This trial investigates the utility of currently practiced and available~     bariatric surgical procedures as compared with multidisciplinary intensive medical and weight~     management for the treatment of T2DM with class 1 and 2 obesity.~   "
190343|NCT01073007|"~     The purpose of this study is to determine whether simvastatin treatment started within the~     first 12 hours from stroke onset improves neurological and functional outcomes, evaluated at~     seventh day/discharge or at the third month.~      Also, to demonstrate that simvastatin is safe and not associated with higher rates of~     hemorrhagic transformation in patients who receive thrombolysis.~   "
190344|NCT01072994|"~     Despite aggressive treatment, patients with heart failure have a poor prognosis.~     Docosahexaenoic acid (DHA), an omega-3 polyunsaturated fatty acids found in fish oils, may~     prevent the progressions of heart failure through mechanisms that are not addressed with~     current drugs.~      The omega-3 polyunsaturated fatty acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic acid~     (EPA) favorably impact mitochondrial dysfunction and chronic inflammation in heart failure~     (HF). Treatment with DHA-t-EPA alters cardiac phospholipid composition by decreasing~     arachidonic acid (a pro-inflammatory fatty acid) and increasing DHA and the mitochondrial~     phospholipid cardiolipin, with is associated with improved Left Ventricular (LV) function.~      Fish oil supplements contain a mix of DHA and EPA, however we postulate that DHA is superior~     to EPA in improving mitochondrial function and suppressing inflammation, and thus DHA should~     be used to treat HF.~      Cardiac phospholipid fatty acid composition (i.e. DHA, EPA, and arachidonic acid) and~     cardiolipin (CL) content will be measured in biopsies from stable heart transplantation~     patients that are obtained as part of standard clinical care in heart transplant patients~     before and after treatment with DHA alone or DHA+EPA. We will compare cardiac phospholipid~     composition from biopsies obtained at study entry and at 6 months follow-up (allowable range~     +/- two months, depending on patients' clinical conditions).~   "
190345|NCT01072981|"~     The purpose of this study is to assess overall survival after treatment with a regimen of~     adjuvant therapy (Gemcitabine alone or with 5-FU chemoradiation) with or without~     HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects who have undergone surgical~     resection.~   "
190346|NCT01072968|"~     Multicenter randomized double blind study versus placebo during 12 weeks with at first, an~     escalating dose period followed by stable dose period at the selected dose.~      This double-blind period can be followed by a 9 months open-label period if the patient~     wishes to continue with the study product.~   "
190347|NCT01072955|"~     The primary objective of this study is to verify, through a randomized, blinded, parallel~     clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when~     compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular~     disease and who require cardiopulmonary bypass, through the control of hemostasis during and~     after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin~     levels and the excessive blood loss (hemorrhage) after the end of surgery.~   "
190361|NCT01072773|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving bortezomib together with combination~     chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and~     dexamethasone together works in treating patients with primary systemic light chain~     amyloidosis.~   "
190348|NCT01072942|"~     The study will be conducted in a single-center, randomized, single-blinded,~     placebo-controlled, dose escalation design with two dose groups.Multiple-dose inhalation of~     Ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 Japanese patients~     with COPD in totalPatients with moderate to severe COPD, stage II or III according to GOLD~     criteria, will participate in the study.The study will consist of 2 steps as indicated below;~     starting at Step 1 (50 mg) and escalating doses up to Step 2 (75 mg), after the tolerability~     of the dose in the previous step is confirmed. In each step, the study will be conducted as~     multiple dose study with b.i.d. regimen for 10 days (between day 2 and 11) in a randomized,~     single-blind, placebo-controlled design. In addition, before and after the multiple dose~     administration, single administration will be conducted in each subject (day 0 and 12).~   "
190349|NCT01072929|"~     The primary objective of the study is to determine whether armodafinil treatment, at a dosage~     of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood~     stabilizers for treatment of adults with major depression associated with bipolar I disorder.~   "
190350|NCT01072916|"~     The proposed pilot project for this seed grant focuses on the role of intestinal~     serine-proteases in the pathogenesis of diarrhea-predominant IBS (D-IBS). In this study we~     will further assess serine-protease activity in patients with D-IBS and also explore a~     possible mechanism by which these proteases can lead to alterations in intestinal physiology~     and symptoms in these patients.~      The general hypotheses for the proposed research are that (A) the levels of fecal~     serine-protease in patients with D-IBS are abnormally increased (B) this abnormal~     serine-protease activity leads to/is associated with an abnormal increase in intestinal~     permeability and therefore enables (C) chronic stimulation and activation of the mucosal~     immune system in these patients. In addition, it is aim to determine whither periodontal~     inflammation is associated with intestinal permeability and serine protease activity.~   "
190351|NCT01072903|"~     The research project addresses the following hypotheses (A) the normal balance of beneficial~     and detrimental commensal intestinal bacteria is deranged in IBS, with selective alterations~     in clinically defined patient subsets i.e., diarrhea predominant IBS (D-IBS) and~     post-infectious IBS (PI-IBS); (B) these changes in intestinal microflora are associated with~     sub-clinical mucosal inflammation and activation of the mucosal immune system; and (C)~     activation of the mucosal immune system leads to alterations in gastrointestinal (GI)~     functions (i.e., motility and sensation) and functional symptoms.~   "
190352|NCT01072890|"~     The purpose of this study is to test the safety of temsirolimus and pazopanib at different~     doses. Patients who have an advanced cancer that is not felt to benefit from standard~     treatment or are no longer responding to other treatment will be asked to take part in this~     study. The study hypothesis is that temsirolimus and pazopanib can be administered safely in~     combination and that combined targeting of the mammalian target of rapamycin (mTOR) and~     vascular endothelial growth factor receptor (VEGFR) signaling pathways will be effective in~     treating patients with advanced solid tumors.~   "
190353|NCT01072877|"~     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and~     may cause discomfort. In this study, patients with varicose veins in the legs will be~     participating. The purpose of this research study is to evaluate the safety and effectiveness~     of three different concentrations of an investigational drug, polidocanol injectable foam~     compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose~     veins.~   "
190354|NCT01072864|"~     To determine the potential acute cardiovascular benefits of California Walnuts in~     postmenopausal women of ages 55-70.~      Primary outcome measures:~        -  Vascular function~        -  Platelet reactivity~      We hypothesize that the consumption of California walnuts will improve vascular function and~     platelet reactivity.~   "
190355|NCT01072851|"~     The objective of this study is to compare the effectiveness of multimedia and print tools~     designed to provide patients at safety-net clinics with comprehensible information about~     colorectal cancer screening and motivate them to complete screening.The print and multimedia~     interventions were constructed with parallel content to allow valid comparison of~     format-related effects on knowledge and screening rates.These easy to use tools will provide~     under served patients at community health centers with clear and consistent messages about~     colorectal Cancer(CRC) and CRC screening, delivered immediately before the patients see a~     doctor.~      Specific Aims~        1. To determine if multimedia and print interventions that provide patients with~          information and motivational messages about CRC screening increase screening rates above~          usual care.~        2. Determine whether showing patients a multimedia program achieves higher CRC screening~          rates than does a print booklet with equivalent messages.~             1. Examine if the effects of these multimedia and print interventions on CRC screening~               rates differ with literacy level.~             2. Examine if the effects of these multimedia and print interventions on CRC screening~               differ with race/ethnicity~             3. Examine if these multimedia and print interventions have differential effects on~               knowledge relevant to CRC screening.~   "
190356|NCT01072838|"~     To determine local disease control (recurrence) with shorter course of APBI delivered with a~     breast brachytherapy applicator.~   "
190357|NCT01072825|"~     The physical and psychological effects of the hormonal treatment of transsexual persons are~     not sufficiently described. 'Transparency' wants to answer this question in a prospective~     manner, in a multicenter study to describe these effects. The low prevalence of~     transsexualism was the stimulus to search for European partners for this Protocol. A common~     standardized hormonal protocol was designed.~   "
190358|NCT01072812|"~     This trial will determine the pharmacokinetics of Posiphen® in both plasma and CSF after a~     10-day treatment period with Posiphen® in subjects with amnestic MCI. The effects of this~     treatment on biomarkers will also be determined in CSF, whole blood, and plasma or serum as~     primary pharmacodynamic (PD) objectives.~   "
190359|NCT01072799|"~     This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety,~     tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A~     (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of~     age).~   "
190360|NCT01072786|"~     Dengue viruses can cause dengue fever and other serious health conditions, primarily~     affecting people living in tropical regions of the world. This study will evaluate the safety~     and immune responses of five formulations of a tetravalent dengue virus vaccine in healthy~     adults.~   "
190363|NCT01072747|"~     The primary objective of this study is to verify, through a randomized, blinded, parallel~     clinical trial, the efficacy of bovine heparin from Bergamo Laboratory ACTIPARIN ® product~     when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery~     cardiovascular disease and who require cardiopulmonary bypass, through the control of~     hemostasis during and after surgery, based on measurements of markers of coagulation ACT,~     aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of~     surgery.~   "
190364|NCT01072734|"~     Annual influenza vaccination is recommended in patients with systemic lupus erythematosus~     (SLE). However some concerns remain about vaccination and the risk of lupus flare~   "
190365|NCT01072721|"~     Early diagnosis of liver fibrosis is useful for the follow-up and treatment of chronic liver~     disease. At present, the unique validated method to evaluate the liver fibrosis in children,~     is the liver biopsy which is an invasive method. If the elastometry method is proved to be a~     good method to evaluate the fibrosis in children, a numerous liver biopsy could be avoided.~   "
190366|NCT01072708|"~     For some years, the investigators observe an increase of the arisen of diabetes in cystic~     fibrosis patients However, this diabetes may be reversible. The investigators speak about ~     Cystic fibrosis related diabetes.. The objective of this project, is to know better what~     facilitates the appearance and the reversibility of the diabetes, such as the genetic~     mutations, the respiratory state and the lung infections. Theses knowledges should allow to~     adapt the screening of diabetes, and its treatment, for the patients affected by cystic~     fibrosis.~   "
190367|NCT01072695|"~     This a phase 2, randomized, open-label trial of GS-9256 plus GS-9190, two oral anti HCV~     drugs, for 28 days with and without ribavirin (RIBA) and with pegylated interferon (PEG)/RIBA~     in adults with chronic Hepatitis C virus (HCV). In Part A, approximately thirty (30) subjects~     18-70 years of age who meet study entry criteria will be randomized (in other words, selected~     at random, like flipping a coin) to one of the two treatment groups (GS-9256 plus GS-9190 or~     GS-9256 plus GS-9190 plus RIBA). In Part B, an additional fifteen (15) subjects will receive~     75 mg GS-9256 BID plus 40 mg GS-9190 BID in combination with PEG/RIBA. After the 28-day~     treatment period, subjects will receive PEG/RIBA as standard of care (SOC).~      Following randomization, subjects will return for a Baseline (Day 1) visit, at which time~     study medication will be dispensed and subjects will enter a 28 day treatment phase. During~     the treatment phase, subjects will receive oral study drugs twice daily for 28 days and PEG~     once weekly for Part B. Subjects then receive PEG/RIBA as local SOC starting on Day 28 (not~     provided as part of the study). Following completion of the 28-day treatment phase, subjects~     will be followed for approximately 72 weeks.~   "
190368|NCT01072682|"~     The purpose of this protocol is to evaluate the safety of a selective cytopheretic device~     (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute renal~     failure (ARF).~   "
190369|NCT01072669|"~     The purpose of this study is to investigate the effectiveness of a drug called ambrisentan,~     approved by the FDA for use in pulmonary hypertension (a condition where there is increased~     pressure in the right side of the heart) in scleroderma patients, to see if this medicine may~     be beneficial in relieving and/or preventing Raynaud's flares in you and other patients like~     you. This medicine may have some short-term and long-term benefits in persons with~     scleroderma~   "
190370|NCT01072656|"~     The purpose of this study is to determine the safety and efficacy of Deep Brian Stimulation~     (DBS) of the ventral capsular/ventral striatal as a treatment for patients with Thalamic Pain~     Syndrome (TPS). The central hypothesis to be tested in this investigation is that VC/VS~     stimulation will modulate the affective component of TPS and, consequently, improve pain~     related disability.~   "
190371|NCT01072643|"~     Clinical dose escalation drug trial to evaluate the effect of 3 different doses of~     dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary~     vascular resistance (PVR). The study will be conducted in 2 parts, with part 1 incorporating~     stopping rules to optimize safety of the drug in this population. The second part of this~     study will evaluate if the lowest safest dose, as determined in part 1, is adequate to~     provide effective sedation during a cardiac catheterization procedure.~   "
190372|NCT01072630|"~     The primary objective of the study is to determine whether armodafinil treatment, at a dosage~     of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood~     stabilizers for treatment of adults with major depression associated with bipolar I disorder.~   "
190373|NCT01072617|"~     The primary aim of this protocol is to determine whether the use of repetitive transcranial~     magnetic stimulation (rTMS) over vermis of the cerebellum may be safe and therapeutically~     effective in patients with schizophrenia. Because this is the first evaluation of this~     treatment in this population, the focus of this study is safety.~   "
190374|NCT01072604|"~     To determine the bioequivalence of new formula of aspirin relative to the established~     commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult~     subjects~   "
190375|NCT01072591|"~     The purpose of this study is to evaluate the safety and tolerability of a single intravenous~     dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will~     also be evaluated how MEDI-578 is absorbed and distributed through the body.~   "
190376|NCT01072578|"~     The primary objective of the study is to assess the effect of dapagliflozin on the amount of~     glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus~     twice a day (5 mg every 12 hours) after five days of dosing.~   "
190377|NCT01072565|"~     The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood~     Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to~     determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes~     management.~   "
190397|NCT01072305|"~     Fluid restriction has become of great interest in perioperative care. There is, however, a~     conflict of interest between fluid restriction and hemodynamic stability. The investigators~     hypothesized that intermittent pneumatic compression may recruit blood from venous capacity~     vessels of the lower limbs and thus enable fluid restriction without compromising hemodynamic~     stability.~   "
190610|NCT01069458|"~     The purpose of this study is to determine whether subjects following a high protein diet will~     gain less in weight after smoking cessation compared to subjects following a low fat diet due~     to the effects of protein on metabolic rate and hunger.~   "
190378|NCT01072552|"~     The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the~     severe RS virus infection during the infancy among preterm infants may reduce the risk of~     subsequent recurrent wheezing in childhood.~      The infants born between July 1st and December 31st in 2007 with the gestational age between~     33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April~     2008. The infants were unintentionally divided into two groups, either palivizumab treated or~     untreated group at the enrollment, because the timing for palivizumab prophylaxis were~     already ended.~      The study infants will be followed up until the age of 3 with recording the incidence of~     either parent reported or physician diagnosed recurrent wheezing.~      The difference of the incidence of the recurrent wheezing between the groups will be analyzed~     with Kaplan-Meier method.~   "
190379|NCT01072539|"~     The primary objective of this study is to identify any changes on the safety profile of~     adverse events and serious adverse events. And the secondary objective is to evaluate~     clinical response in the clinically evaluable population at test-of cure (TOC) or at the end~     of treatment (EOT) assessment, and microbiologic response at the subject level, if available.~   "
190380|NCT01072526|"~     The purpose of this study is to determine whether a homeopathic therapy in combination with~     cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment~     of dry eye disease.~   "
190381|NCT01072513|"~     The purpose of this study is to evaluate semen for changes following treatment with proton~     radiation therapy.~   "
190382|NCT01072500|"~     Based upon promising results from a pilot study among 424 sedentary older adults who were~     randomized to a physical activity intervention or a successful aging health education~     intervention, a Phase 3 multi-center randomized controlled trial is being conducted to~     compare a moderate-intensity physical activity program to a successful aging health education~     program in 1,600 sedentary older adults who are followed for an average of 2.7 years.~      The primary aim was to assess the long-term effects of the proposed interventions on the~     primary outcome of major mobility disability, defined as inability to walk 400 m.~   "
190383|NCT01072487|"~     In the study the value of capnography for avoiding complications during sedation for~     colonoscopy is evaluated.~   "
190384|NCT01072474|"~     In the study the value of capnography for avoiding complications during sedation for ERCP is~     evaluated.~   "
190385|NCT01072461|"~     The complexity of sensorimotor control required for hand function as well as the wide range~     of recovery of manipulative abilities makes rehabilitation of the hand most challenging. The~     investigators past work has shown that training in a virtual environment (VE) using~     repetitive, adaptive algorithms has the potential to be an effective rehabilitation medium to~     facilitate motor recovery of hand function. These findings are in accordance with current~     neuroscience literature in animals and motor control literature in humans. The investigators~     are now in a position to refine and optimize elements of the training paradigms to enhance~     neuroplasticity. The investigators first aim tests if and how competition among body parts~     for neural representations stifles functional gains from different types of training~     regimens. The second aim tests the functional benefits of unilateral versus bilateral~     training regimens.The third aim tests whether functional improvements gained from training in~     a virtual environment transfer to other (untrained) skills in the real world.~   "
190386|NCT01072448|"~     This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.~   "
190387|NCT01072435|"~     Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in~     many ways: by infusion or intravenous boluses and with self-administration device~     (patient-controlled sedation; PCS). It is not clear which method of propofol administration~     would be preferable. The main objective of the trial is to compare 2 different methods of~     propofol administration during ERCP: patient-controlled administration(PCS) and~     target-controlled infusion (TCI).~   "
190388|NCT01072422|"~     The purpose of this study is to determine if an assessment protocol that measures the need~     for support with smoking cessation and that will be administered by primary health care~     nurses helps patients with obstructive pulmonary disease (COPD) quit smoking.~   "
190389|NCT01072409|"~     To evaluate the performance of the Nucleus 5 Cochlear Implant System.~   "
190390|NCT01072396|"~     Optimal clinical management in early stages of COPD is not established. Tiotropium has been~     shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV~     COPD, improvements in constant speed treadmill time in a study of patients who also received~     pulmonary rehabilitation in a population of patients with predominantly severe and very~     severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle~     Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits~     of tiotropium on exercise tolerance in a patients with early stages of COPD who are~     symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients)~     may benefit from maintenance therapy and there is limited data on exercise limitation in~     patients with early stage COPD who are symptomatic. This study is designed to evaluate the~     mechanisms of breathlessness and assess physical activity limitation in early stage COPD~     patients compared to age and gender matched controls and will secondly investigate the~     effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise~     duration as a result of the bronchodilation effects of tiotropium leading to a reduction of~     dynamic hyperinflation in Early Stage COPD patients.~   "
190391|NCT01072383|"~     This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given~     as repeated doses.~   "
190392|NCT01072370|"~     The purpose of this study is to test the safety and effectiveness of a cord blood infusion in~     children who have motor disability due to cerebral palsy (CP). The subjects will be children~     whose parents have saved their infant's cord blood, who have non-progressive motor~     disability, and whose parents intend to have a cord blood infusion.~   "
190393|NCT01072357|"~     The leading risk factor for corneal transplant rejection is abnormal blood vessel growth of~     the host bed. Vascular endothelial growth factor (VEGF) is thought to be a mediator of this~     corneal neovascularization (NV), therefore we would like to test the safety and efficacy of~     local VEGF blockade in the promotion of graft survival in high risk corneal transplants.~   "
190394|NCT01072344|"~     Prior research has shown that chamomile may be an effective, short-term anti-anxiety~     treatment. This study will examine the initial and long-term benefits of chamomile extract~     therapy for the prevention of recurrent anxiety disorder.~   "
190398|NCT01072292|"~     A two-phase research study is being conducted. In Phase 1 of the study, the cognitive~     behavioral therapy intervention for insomnia was implemented in a small (n = 5) group of~     people with moderate to severe COPD and insomnia. The intervention was pilot-tested to~     determine feasibility and acceptability, and the intervention will be refined as needed. In~     Phase 2 of the study, a two-group randomized controlled study (n = 20) will be conducted to~     test the effects of the cognitive behavioral therapy for insomnia intervention on the primary~     outcomes of sleep quality and fatigue and the secondary outcomes of mood and functional~     performance. It is hypothesized that people with COPD receiving cognitive behavioral therapy~     for insomnia will demonstrate significant improvements in sleep quality, fatigue, mood and~     functional performance as compared to people with COPD who receive a wellness program. This~     research will yield valuable information regarding effective interventions aimed at~     mitigating problems such as poor sleep quality, fatigue and reduced ability to perform valued~     daily activities. This information will be used to increase the likelihood of long-term~     successful outcomes such as the ability to maintain productive roles in society for people~     with COPD.~   "
190399|NCT01072279|"~     A study conducted by IFPRI in Haiti provided the first programmatic evidence, using a cluster~     randomized evaluation design, that preventing child undernutrition in children under two~     years of age (PM2A) through an integrated program providing food rations, BCC and preventive~     health and nutrition services is both feasible and highly effective. The study's principal~     aim was to compare a newly designed preventive approach with the traditional (recuperative)~     food assisted MCHN program approach, and therefore included only two comparison groups: one~     group of communities that was randomly assigned to the preventive approach and another group~     assigned to the recuperative approach. For logistical and financial reasons, the study did~     not include a randomized control group receiving no intervention.~      The Haiti study design was well-suited to achieve its main goal - i.e. to test whether the~     preventive approach was more effective than the recuperative approach at preventing child~     undernutrition - but it left a number of questions unanswered.~      The present study will address several of these questions, which will allow to further refine~     the PM2A approach, facilitate its replication in different contexts, and maximize its impact~     and cost-effectiveness in future programming. The study will be conducted in Guatemala and~     Burundi. The key research objectives are:~        1. Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child~          nutritional status.~        2. Optimal composition and size of food rations in PM2A: Assess the differential and~          absolute impact of varying the size and types of foods incorporated in the food ration~          of the PM2A. More specifically, assess the differential effect of different sizes of~          family food rations, and assess the impact of substituting the individual food ration~          with new micronutrient-rich products such as lipid-based nutrient supplements (LNS) or~          micronutrient Sprinkles.~        3. Optimal timing and duration of PM2A: Assess the differential and absolute impact of~          varying the timing and duration of exposure to PM2A on child nutritional status.~   "
190400|NCT01072266|"~     This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060~     (study drug) is safe, well-tolerated and effective in patients with advanced malignancies.~     Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28~     days before the next group is enrolled and may begin to receive study drug. Doses will be~     escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.~   "
190401|NCT01072253|"~     The purpose of this study is to evaluate eye amputated patients health related quality of~     life, perceived stress, self-rated health, labour marked participation and socio-economic~     position.~      The investigators hypothesis is that quality of life, perceived stress and self- rated health~     of many eye amputated patients are drastically changed. Eye amputation has a marked negative~     influence on labour marked participation and socio-economic position of the patients.~   "
190402|NCT01072240|"~     This observational study will monitor and register infusion-related adverse events and their~     handling in patients with chronic lymphocytic leukemia on treatment with MabThera~     (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of~     375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6~     months. Target sample size is 100 patients.~   "
190403|NCT01072227|"~     The purpose of the study is to identify the bacterial aetiology of Acute Otitis Media~     episodes in young children aged >= 3 months to < 5 years in Taiwan~   "
190404|NCT01072214|"~     A study to determine the safety and tolerability of pazopanib eye drops. The study will also~     determine how the drug is absorbed and metabolized over time. Repeat doses of eye drops will~     be administered to healthy adult volunteers over a 14-day period with one additional dose~     given on the 15th day of the session. Three groups of subjects may receive either active drug~     or placebo (drops without drug). The first group of subjects will receive a maximum of 1.6mg~     of pazopanib or placebo. The dose of drug to be given to the next two groups will be~     determined based on the results of the first group of subjects. The last group of subjects~     will be of Japanese descent.~   "
190405|NCT01072201|"~     Clinical research for the treatment of mucositis subjects who have dental implants for a~     minimum of one-year.~   "
190406|NCT01072188|"~     The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste~     containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a~     pre-procedure to a professional dental cleaning.~   "
190407|NCT01072175|"~     This is an open-label, dose escalation study to investigate the safety, pharmacokinetics,~     pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This~     study is designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the~     pharmacokinetics of single dose GSK2118436, will be investigated prior to evaluating~     combination regimens. In Part B, the range of tolerated dose combinations will be identified~     using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and~     GSK1120212 will be evaluated, based on results from the dose escalation cohorts. In Part D,~     the pharmacokinetics and safety of GSK2118436 administered as HPMC capsules alone and in~     combination with GSK1120212 will be evaluated.~   "
190408|NCT01072162|"~     This is a randomized, open-label, five-period, balanced crossover study conducted in~     approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects~     receive five eltrombopag treatments: tablet fasted, Powder for Oral Suspension (PfOS) fasted,~     PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours~     after a high calcium meal, and each treatment is a single 25 mg dose. There is a 10 to 14 day~     washout between periods, and between the last dose of study drug and the follow-up visit.~     During each treatment period, subjects undergo serial PK sampling over 72 hours for~     measurement of plasma eltrombopag concentrations. Safety is assessed by vital signs, clinical~     safety laboratory assessments, and adverse events reporting.~   "
190553|NCT01070238|"~     The study was conducted~        1. to investigate the superiority of isomaltulose in reduction of postprandial~          hyperglycemia~        2. to describe the kinetics of glucose absorption after a load of isomaltulose~        3. to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2~          diabetic patients.~   "
190409|NCT01072149|"~     The Purpose of this study is to evaluate the 24-hour spirometry effect Forced Expiratory~     Volume in One second (FEV1) of 3 doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder~     at the end of a 28-day treatment period in subjects with Chronic Obstructive Pulmonary~     Disease (COPD) compared with placebo. Other objectives are to assess additional efficacy,~     plus the safety, pharmcodynamics and tolerability of concurrent treatment with Fluticasone~     Furoate (FF) plus GW642444 when administered at three dose levels for 28 days in subjects~     with COPD and to assess the steady-state pharmacokinetic profile of Fluticasone Furoatee (FF)~     and GW642444 at the end of each treatment period.~   "
190410|NCT01072136|"~     Mucopurulent cervicitis (MPC) is a syndrome with associated symptoms including mucopurulent~     discharge (mucus and pus) from the cervix and other signs of inflammation such as easily~     induced cervical bleeding. The purpose of this study is to evaluate the effectiveness of no~     treatment versus empiric treatment with a single dose of cefixime and azithromycin for cure~     of MPC. Empiric treatment is the initiation of treatment prior to a firm diagnosis. Study~     participants will include 772 women ages 18 and older in good health with MPC. Women will be~     randomly assigned to 1 of 2 possible study groups: Group 1 will receive a single dose of~     cefixime and azithromycin antibiotics and Group 2 will receive placebo (inactive substance).~     Study procedures will include pelvic examination with a cervical swab sample. Participants~     will be involved in study related procedures for approximately 2 months, which includes 3~     study visits.~   "
190411|NCT01072123|"~     This is a single center pilot study designed to evaluate the effectiveness of an asthma~     education program in the pediatric emergency department. Asthma has reached epidemic~     proportions. Nine million American children are affected in the United States alone. This~     problem has increased 75% from 1980 to 1994, with a staggering 160% increase seen in children~     less than five years old.1 The American Lung Association has targeted this overwhelming~     problem on both national and local levels. Asthma impacts American communities who differ~     geographically, culturally, ethnically and by lifestyle, and as a result will present with~     different obstacles.~      The primary objectives are: to determine whether this educational intervention (through~     interactions with a child life specialist and using the asthma based computer game) in the~     pediatric ED can influence children's [and care givers'] knowledge and understanding of the~     disease process and treatment, and to improve asthma self-management and decrease morbidity~     by decreasing ED use and hospitalization.~      A secondary objective is to introduce the Child Life Specialist as an effective asthma~     educator and further strengthen the health care team.~      The target population will be recruited from the pediatric emergency department. We~     anticipate this study to recruit over a one year period and have a one year follow up with an~     anticipated enrollment of 64 children and families. There will be three Child Life Specialist~     involved in this program.~      After consent has been obtained, the child and parent will complete questionnaires (focusing~     on asthma knowledge, quality of life, and perception of asthma) and then a laptop will be~     provided to access the asthma based computer game.~      During the child's ED visit the Child Life Specialist will have opportunities to open~     communication to address barriers or concerns, and reinforce material provided by the game.~     Through these interactions, the importance of communication between the child, parent and~     healthcare provider is highlighted.~      The family will be given information to access the computer game via the internet. Follow up~     phone calls or e-mails will occur at 6 months, 9 months, and 12 months which will entail~     completing questionnaires. The questionnaires uses validated questions along with questions~     from the material covered through this asthma education study.~   "
190412|NCT01072110|"~     The main objective of this study is to determine the frequency of different gastrointestinal~     disorders as the cause of diarrhea in patients at a tertiary referral center using confocal~     laser endomicroscopy.~   "
190413|NCT01072097|"~     This is a placebo controlled trial investigating the effect of 6 months atorvastatin 20mg/day~     therapy on androgens, glucose metabolism and inflammatory markers in women with PCOS.~      We assume that during 6 months atorvastatin therapy a significant improvement in~     hyperandrogenism, glucose metabolism and inflammatory markers is observed.~   "
190414|NCT01072084|"~     The purpose of this study is to evaluate the endoscopic diagnostic options of the~     endomicroscopy in patients with food intolerance.~   "
190415|NCT01072071|"~     Intra-abdominal hypertension (IAH) is a frequent cause of organ dysfunction in critically ill~     patients. Secondary IAH is mainly caused by excessive fluid resuscitation.The World Society~     for the Abdominal Compartment Syndrome (WSACS) recommends using diuretics to remove excess~     fluids and decrease intra-abdominal pressure (IAP). However, critically ill patients may not~     tolerate negative fluid balance in the acute phase of their disease and the injured kidney~     may not respond to diuretics. The aim of this study is to evaluate the influence of~     furosemide on fluid balance, IAP and kidney function in critically ill patients.~   "
190416|NCT01072058|"~     The purpose of this study is to determine possible alterations in cardiac function in~     patients with Rheumatoid Arthritis and Ankylosing Spondylitis under anti-TNF therapy, without~     clinical heart disfunction at baseline, using highly sensitive non-invasive methods.~   "
190417|NCT01072045|"~     Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most~     frequent benign neoplasm.~      Treatment of IHs is indicated for approximately 10 to 20% of the cases. Two groups can be~     defined amongst indications for treatment: patients with absolute indication for treatment~     and patients with relative indication for treatment.~      Absolute or emergency indications comprise function or life threatening situations such as~     obstruction of airways, obstruction of vision, congestive heart failure, hepatic and~     coagulation problems.~      The following are considered relative indications: cases of large and disfiguring facial~     hemangiomas; locations that can result in a deformity and/ or permanent scar (nose, ear, lip,~     glabellar area); extensive face hemangiomas, mainly when there is dermal damage (more~     probable to scar); local complications such as ulceration, infection and bleeding as well as~     small hemangiomas in exposed areas (hands and face), mainly if pedunculated due to its ease~     of excision2,7.~      Treatment modalities vary according to the extension, location, presence of complications and~     the evolutional phase. A combination of various treatments is possible.~      Beta blockers are being used in children for approximately 40 years, with proven clinical~     safety and no cases of death or cardiovascular disease resulting from its direct use.~     Recently it was reported the use of beta blockers (propanolol) for IH treatment, with~     significant reduction of tumor volume after introduction of the beta blocker, in a short~     period of time, with stable results after the end of treatment, which suggested evidences of~     the benefits of this drug in the tumor treatment The proposal of this study is to assess the~     use of propanolol in IH treatment, quantifying its effectiveness and safety under continuous~     monitoring and comparing it to the use of oral corticosteroid. The investigators propose the~     assessment of the betablockers' use in comparison to the use of corticosteroids in infants~     with IH in the proliferative or involuting phases, with indication for clinical treatment,~     and that are not alarming nor urgent; in other words, the current relative indications for~     treatment.~   "
190433|NCT01071837|"~     This is a phase II study of APG101 + reirradiation (RT) versus reirradiation. Patients~     suffering from a malignant brain tumor called glioblastoma having a first or second~     progression can be included. They will be randomized to RT or RT + APG101.~      APG101 is a fusion protein (similar to an antibody) and will be administered as a weekly~     infusion. Patients can stay in this study as long as they benefit from the participation (no~     fixed end).~      In this trial, 30-35 sites in Germany, Austria and Russia take part.~   "
190434|NCT01071824|"~     The aim of the study is the comparison of pouch function with two different sizes of limb of~     transverse coloplasty pouch after rectal resection and total mesorectal excision.~   "
196545|NCT00990730|"~     The purpose of this study is to investigate the link between rheumatoid arthritis and~     cardiovascular disease by studying inflammation, joint disease, cholesterol abnormalities,~     and endothelial function.~   "
190418|NCT01072032|"~     Reduced mobility is often a long-term problem facing those who have chronic leg weakness~     resulting from stroke. Recent innovations in stroke therapy have applied motor learning~     principles to improve motor skills through regular practice of activities using the weaker~     limb. Because the ankle provides critical torques for normal walking and mobility function,~     impairments at the affected ankle pose a major limitation to achieving optimal mobility~     recovery. To address this we have developed a novel ankle robot (Anklebot) to enhance~     physical therapy for improving walking and mobility after stroke. This computer controlled~     device provides assistance when users cannot complete a movement, but will not assist if the~     user is active.~      Motor learning requires active involvement in task-related practice to mediate brain~     plasticity. While voluntary movement is important to remodel motor control circuits, the~     brain mechanisms of reward and motivation also can play an important role. Core brain~     networks involved in reward and motivation increase a person's involvement with their~     surroundings, to focus attention and to prompt one to approach reward and avoid punishment.~     This increased involvement and the elevated emotions associated with it have been shown to~     enhance performance, memory and learning.~      The purpose of this study is to investigate responses of brain and motor behavior of stroke~     patients who use the Anklebot during a 3-week / 3-session/week motor learning based training.~     These responses are compared to a 3-week delayed entry period in which the participants will~     perform an at-home walking program of equal time. After the 3-week delayed entry walking~     program, subjects are divided into low and high reward-feedback groups. The low~     reward-feedback group receives the Anklebot training with only immediate feedback on target~     successes, without cumulative scores and with minimal social interaction with the~     researchers. The high-reward group receives cumulative scores and ongoing social support, are~     eligible for prizes during each session and at the study's completion. All subjects play the~     games as noninvasive electroencephalography and electromyography record brain and muscle~     activity. In addition to analyzing brain information before and after the Anklebot training,~     ankle motor control and walking functions are also assessed immediately before and after the~     first and last robotic training sessions.~   "
190419|NCT01072019|"~     The purpose of this study is to determine the surgical and clinical outcomes of patients~     receiving total knee replacement with the same implant using two different types of cutting~     guides during surgery:~        1. Standard knee cutting guides;~        2. MRI generated patient specific custom cutting guides.~      Both types of cutting guides used in this study are registered with the U.S. Food and Drug~     Administration (FDA) and are routinely used for knee replacement surgery. However, it is~     unknown if one type of cutting guide has risks or benefits over the other.~   "
190420|NCT01072006|"~     This research investigates processes involved with one being able to focus on relevant~     information and ignore non-relevant information in veterans with PTSD and those with a~     history of traumatic brain injury. In addition, this study evaluates whether there is an~     additive effect of having both PTSD and history of TBI on ability to focus attention and~     inhibit distracting information.~   "
190421|NCT01071993|"~     To determine if statin therapy plus intravenous normal saline, in patients with chronic renal~     insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline~     therapy in the prevention of CIN.~   "
190422|NCT01071980|"~     The purpose of this study is to investigate the effect of specific resistance training on~     neck/shoulder pain in industrial workers.~   "
190423|NCT01071967|"~     Care coordination, disease management, geriatric care management, and preventive programs for~     chronically ill older adults vary in design and their impact on long-term health outcomes is~     not well established. This study investigates whether a community-based nursing intervention~     improves longevity and impact on cardiovascular risk factors in this population. The results~     reflect the impact of one of the study sites (Health Quality Partners) selected by the~     Centers for Medicare and Medicaid Services (CMS) to participate in the Medicare Coordinated~     Care Demonstration, a national demonstration designed to identify promising models of care~     coordination for chronically ill older adults. The study began in April 2002.~   "
190424|NCT01071954|"~     This is an extension study designed to assess the safety and durability of platelet count~     increases with romiplostim treatment of thrombocytopenic subjects with Immune (Idiopathic)~     Thrombocytopenia Purpura. This study is available to pediatric subjects who have completed a~     previous romiplostim ITP study and meet the eligibility criteria of this study.~   "
190425|NCT01071941|"~     The purpose of this research study is to determine the safety of rRp450 and the highest dose~     of this agent that can be given to people safely. We are also looking to see how well the~     body tolerates the study agent, how the agent is absorbed by the liver cancers, how quickly~     the agent is eliminated from the body, and what kind of anti-cancer effect it may have.~     rRp450 is a type of gene therapy and a form of the Herpes simplex virus 1 (or HSV). HSV is a~     virus that usually causes cold sores of the mouth. In extremely rare circumstances, this~     virus can cause severe infections, such as an infection of the brain. rRp450 was developed~     from an HSV and specially altered to target and kill cancer cells.~   "
190426|NCT01071928|"~     The purpose of this study is to explore the safety and activity of docetaxel + ASA404 as~     second-line chemotherapy in patients with advanced urothelial carcinoma.~   "
190427|NCT01071915|"~     This is an open-label, multi-centre single arm trial to investigate efficacy and safety of~     degarelix in Korean patients with prostate cancer for bridging between CS21 trial~     (NCT00295750) results.~   "
190428|NCT01071902|"~     The purpose of this study is to determine if Moxidex otic solution is safe and effective in~     treating middle ear infections in patients with ear tubes.~   "
190429|NCT01071889|"~     The purpose of this study is to evaluate the safety and effectiveness of treatment with~     sublingual (s/l) Flumazenil in healthy volunteers as reversing the effect of the~     sleep/hypnotic drugs. This study is designed to collect short-term safety and tolerability~     data.~      In addition, the psychomotor/ cognitive and behavioral effects of Flumazenil will be assessed~     to monitor the degree and the duration of action in a single use of Flumazenil.~   "
190430|NCT01071876|"~     Multicenter randomized double blind study versus placebo during 12 weeks with at first, an~     escalating dose period followed by stable dose period at the selected dose.~      This double-blind period can be followed by a 9 months open-label period if the patient~     wishes to continue with the study product.~   "
190431|NCT01071863|"~     Primary Objective:~      To identify the prevalence and severity of the fear of falling in a rheumatoid population~      Secondary Objectives:~      To explore the effect the treatment with biological agents has on fear of falling and~     physical activity in a rheumatoid population~   "
190432|NCT01071850|"~     Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to~     placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.~   "
190500|NCT01070927|"~     This study will evaluate the anti-tumour activity, safety and tolerability of RO4929097 as~     monotherapy in patients with recurrent or refractory non-small cell lung cancer. Patients~     will receive oral doses of RO4929097 of 80mg (cohort 1) or recommended Phase II dose (cohort~     2) on a 3 days on 4 days off schedule. Anticipated time on study treatment is until disease~     progression or unacceptable toxicity. Target sample size is <50.~   "
190435|NCT01071811|"~     Physical activity is associated with a reduced risk of several chronic diseases in addition~     to all-cause mortality. Hence for public health purposes, knowledge of effective~     interventions to increase the physical activity level in the population is important.~      The objective of this randomized controlled trial was to examine the effect 12 weeks after~     having received a pedometer and a pedometer program on physical activity, health~     measurements, self-rated health, stress, and sleep quality.~      A total of 223 men and 445 women were randomly assigned to either a pedometer group (n = 333)~     in which participants received a pedometer and pedometer program or a control group (n =~     335). Of the participants included in the study 198 and 178 completed the health examination,~     and 192 and 187 completed the questionnaire at follow up in the pedometer group and in the~     control group, respectively.~   "
190436|NCT01071798|"~     This prospective observational study aims to evaluate safety, application and onset of effect~     of rituximab in clinical routine treatment of severe active rheumatoid arthritis during the~     first 6 months (in case of re-therapy: 12 months).~   "
190437|NCT01071785|"~     Metabolic Syndrome (MS) is an clinical condition with high cardiovascular risk. More than 80%~     of DM patients had MS. Dietary factors can be associated to both, DM and MS. Therefore the~     aim of this study is to evaluate the effects of add soluble fiber (goma-guar) in the usual~     diet of type 2 DM with MS and compare this intervention with an usual diet without this~     supplement.~   "
190438|NCT01071772|"~     Diabetes and Heart Failure are diseases with high morbidity and increased risk of death.~     Former investigations has shown that diabetes worsens the prognosis of heart failure. However~     it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac~     function.~      Our hypothesis is that short term dysregulation affects left ventricular function and~     exercise capacity in insulin treated type 2 diabetics with and without heart failure.~      To elucidate this hypothesis diabetic patients with and without heart failure will be~     investigated after overnight state of either high or normal blood glucose levels on two~     separate occasions. Metabolic and hormonal parameters will be measured. Systolic and~     diastolic cardiac function will be assessed, exercise capacity and post exercise regional~     myocardial tissue velocity as well as 6 minutes walk test will be investigated on both~     occasions. The study will be a randomized cross-over design.~   "
190439|NCT01071759|"~     Iron deficiency is considered one of the main nutritional deficiency disorders despite the~     apparent availability of a high-quality diet even in developed countries, and Iron deficiency~     anemia (IDA) is the most common form of anemia in the world. IDA during pregnancy has been~     associated with adverse health consequences for both the mother and her developing fetus.~     Helicobacter pylori (Hp) may be the most common bacterial infection worldwide, infecting~     almost half of people in developed countries and 80% of people in developing countries. The~     available data on the prevalence of Hp infection in Taiwan population was 54.4%. We all know~     that infection with Hp is strongly associated with peptic ulcer and gastric cancer, but~     recent evidence suggests that Hp is associated with iron deficiency and anemia, although the~     mechanisms remain unclear. Till now, only few previous studies specifically have addressed a~     potential role of Hp infection on anemia or iron deficiency during pregnancy. Our previous~     Research showed, between the Hp infection (+) and Hp infection (-) gravidas, the associations~     between the Hp infection and iron deficiency were stronger, although not statistically~     significant. This might be due to that we needed more cases and evidences to prove the~     relationship between maternal Hp infection and serum iron, ferritin and hemoglobin levels, or~     we should further consider the interactions of the particular customs or diet preference of~     the Taiwanese gravidas. This longitudinal study will recruit 140 women from the antenatal~     care clinics of E-Da Hospital to examine the association between Hp infection and maternal~     IDA. The standardized interviews of mothers (anthropometric data, socioeconomic status,~     medical history, obstetric history, alcohol consumption during pregnancy, and history and~     duration of iron supplementation during pregnancy) will be conducted, Hp infection status~     will be determined by the urea breath test and IgG enzyme immunoassay, and the measurement of~     hemoglobin, iron, and ferritin levels will be obtained 5 times at various antepartum and~     postpartum points of time during pregnancy (routine prenatal visits of 1st, 2nd, and 3rd~     trimester, puerperium and 2 weeks after delivery). We hope that we could investigate the~     possible role of Hp infection in iron deficiency and iron-deficiency anemia during pregnancy~     in Taiwan, and that early detection and treatment of anemia may reduce the risk of blood~     transfusion and perinatal and maternal mortality.~   "
190440|NCT01071746|"~     Patients with acute on chronic liver failure have a risk of developing multiorgan failure and~     a high mortality. The current scoring systems defining the outcome of patients with acute~     decompensation of cirrhosis fail to identify patients that progress to Acute-on-chronic liver~     failure (ACLF).~      The aim of the study is to evaluate if one can identify these patients early on with the~     proposed biomarkers: dimethylarginines and ischemia modified albumin.~   "
190441|NCT01071733|"~     The purpose of this study is to compare fracture diagnostic, conventional x-ray versus~     ultrasound.~   "
190442|NCT01071720|"~     The purpose of this study is to assess the effect of food on the pharmacokinetic~     characteristics of CKD-501 in healthy subject.~      And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.~   "
190443|NCT01071707|"~     Study purpose:~      The disease course of idiopathic pulmonary fibrosis (IPF) is variable. During the course of~     the disease some patients will get better, some will stay the same, and others will get~     worse. Currently doctors do not have any way to predict an individual patients disease~     course. The purpose of this study is to determine if 'biomarkers' such as proteins or genes~     isolated at the time of diagnosis can be used to predict the disease course. These~     'biomarkers' will be obtained from samples of blood, from a procedure call a bronchoscopy,~     and in some patients from extra tissue obtained by a surgical lung biopsy.~   "
190444|NCT01071694|"~     This study is to describe the quality of life of Korean patients with early~     relapsing-remitting multiple sclerosis during the initial 1 year of treatment with Betaferon~     with several validated questionnaires.~   "
190445|NCT01071681|"~     This study will describe the factors influencing the physician in face of elevated blood~     pressure in already treated patients~   "
190462|NCT01071460|"~     Purpose of this registry is to determine the efficacy and safety of the self-expanding, extra~     flexible FlexStent in patient with superficial femor/popliteal artery disease.~      The stent has been developed to cope with the extreme requirements of the femoral artery/knee~     artery and is approved for usage at humans (EC-certified). It is designed to treat narrows of~     the femoral- and knee artery.~      100 patients at 5 German hospital shall be enrolled. After stent implantation follow-up~     visits at 6 and 12 month take place.~   "
190463|NCT01071447|"~     Randomized controlled trial including 100 subjects with rheumatic diseases and biological~     treatment with a 28 point-Disease Activity Score(DAS28)3.2 or less. The subjects will be~     randomized to either nurse-led clinic or rheumatologist-led clinic. The hypothesis is that~     there will be no difference in DAS28 between the two groups after 1 year follow-up.~   "
190464|NCT01071434|"~     This study aims to investigate and optimize imaging sequences and parameters of rapid~     real-time MRI in order to obtain adequate guidance for accurately and precisely delivering~     radiation to moving abdominal and thoracic tumors.~   "
190446|NCT01071668|"~     Premature birth is a public health problem and its incidence has recently increased in all~     developed countries. In Canada, it represented 6.4% of births in 1981 and 7.6% in 2000. In~     the last decade, the survival rate of premature infants has increased considerably, but~     neurological vulnerability has not changed. Premature births are the cause of approximately~     28% of neonatal mortality in the world and is the major cause of perinatal mortality and~     morbidity in developed countries.~      Approximately 75-80% of preterm births are spontaneous preterm birth. This type of premature~     birth included the preterm labor and premature rupture of membranes before term. The~     contractile activity represents one of the fundamental properties of the uterus during~     pregnancy and childbirth. The abnormalities associated with uterine contractions are the~     cause of pathological conditions with important consequences for the mother and fetus.~      Metabolomics involves a new technology to investigate small molecules that characterize~     biochemical pathways of interest. The change in concentration levels of these molecules in~     various biological samples such as urine and blood in the presence of a disease or a patient~     can be particularly useful for identifying new biomarkers.~      The hypothesis of this study is that gestational metabolomes detected in maternal fluids~     differ according to pathological situations and lead to the initiation of spontaneous labor.~     The whole research program has two complementary objectives in order to expect a decrease of~     prematurity: a) better understanding of all the physiological mechanisms leading to~     prematurity and b) better identification of patients at high risk for a better management of~     these women.~   "
190447|NCT01071655|"~     The purpose of the study is to evaluate the efficacy and safety of the capecitabine or~     5-fluorouracil selection, according to polymorphisms in TS-3'UTR and ERCC1-118, to be~     combined with oxaliplatin or irinotecan as first-line chemotherapy in advanced colorectal~     cancer~   "
190448|NCT01071642|"~     The aim of the current study is to evaluate prospectively whether concomitant administration~     of RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after~     administration of contrast media in patients undergoing non-emergent coronary angiography.~   "
190449|NCT01071629|"~     Chronic heart failure (CHF) is a common syndrome characterized by several central hemodynamic~     and peripheral vascular and muscle abnormalities including autonomic imbalance,~     neuro-hormonal over-activation and decreased oxidative status.~      In patients suffering from CHF, exercise confers several beneficial effects on the~     cardiovascular and peripheral systems, mainly by continuous aerobic training. However,~     interval aerobic training has also been validated as an alternate form of training that~     increases the exercise capacity of patients who are in CHF.~      Recent studies have suggested that resistance training alone or as a complementary program~     besides the traditionally aerobic continuous training might exert favorable effects. However,~     little it is known about the combined effects of interval and strength training in CHF~     patients.~      Aim of this prospective randomized controlled study was to investigate the effects of~     combined interval and strength training comparing to interval training alone in CHF patients.~   "
190450|NCT01071616|"~     Background:~      - Little research has been done on how different components of cannabis (marijuana) appear in~     oral fluid (i.e., saliva) after smoking. Cannabinoids have been well studied in whole blood,~     plasma, and urine after cannabis use, but less is known about how cannabinoids appear in oral~     fluid after controlled drug administration and how long these biomarkers last after use. In~     addition, the issue of stability of cannabinoids and their glucuronide metabolites is a~     controversial topic that is poorly understood. These data are critical to the interpretation~     of cannabinoid test results.~      Objectives:~        -  To collect whole blood, plasma, urine, and oral fluid specimens after smoking cannabis,~          to characterize the disposition and pharmacokinetics of cannabinoids in multiple~          biological matrices and to provide scientifically reliable data on the stability of~          cannabinoids and metabolites.~        -  To test basic brain function and thinking processes after smoking cannabis.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age who use cannabis (an average of at least~     twice per month in the 3 months before the study.)~      Design:~        -  Participants may complete the single study session as outpatients, or they may spend the~          night prior to and/or following drug administration at the residential research unit in~          Baltimore, MD. Participants must provide a negative urine drug screen if they have not~          spent the evening prior to testing at the research unit.~        -  Participants will provide whole blood, plasma, oral fluid, and urine samples, and will~          complete several tests of thinking and brain function at the start of the study.~        -  Participants will smoke one standardized cannabis cigarette. Blood and oral fluid~          samples will be collected, and participants will repeat the tests of thinking and brain~          function multiple times after smoking.~        -  Six hours after smoking the cigarette, participants must pass a neuromotor exam (testing~          balance and coordination) before they can be discharged from the study. Participants may~          be asked to stay overnight at the clinical center if there are concerns for their safety~          because of intoxication.~   "
190451|NCT01071603|"~     Background:~      - In spite of well-researched treatments and therapies, 5 to 10 percent of tuberculosis (TB)~     patients who have initially successful TB treatments will relapse, usually within a year~     after completion of therapy. This percentage is even greater for patients who are infected~     with multi-drug resistant and extensively drug resistant types of TB. Because the People s~     Republic of China has the second highest number of TB cases in the world, researchers are~     interested in studying TB patients in China to evaluate their response to treatment on a~     long-term basis.~      Objectives:~        -  To improve TB diagnosis and testing by determining the number and proportion of patients~          admitted with suspected TB who actually have TB (definite or probable).~        -  To assess the prevalence of non-tuberculosis bacteria among patients with presumed TB.~      Eligibility:~      - Individuals between 18 and 65 years of age who have been admitted to Henan Provincial Chest~     Hospital with suspected tuberculosis.~      Design:~        -  Participants will be divided into three groups, based on their diagnosis after~          admission. Another group of individuals who do not have TB will be enrolled as controls~          for comparison purposes during the study.~        -  The study will use computed tomography (CT) scans of the chest at initial enrollment, 2~          months, and 6 months to evaluate disease response to treatment. Incidents of TB that are~          not in the chest area (extrapulmonary TB) will also be studied.~        -  The study will also monitor the treatments and therapies used against the disease,~          changes in patients immune systems, and any changes in the biological samples taken over~          the course of treatment.~   "
190486|NCT01071122|"~     To determine whether the combination of nifedipine GITS and valsartan is more effective in~     reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine~     whether nifedipine GITS is comparable to valsartan~   "
190521|NCT01070654|"~     Recruitment manoeuvres, consisting of sustained inflations at high airway pressures, have~     been advocated as an adjunct to mechanical ventilation in lung protective ventilation~     strategies to prevent the collapse of the lung.~      This study aims to determine the safety and efficacy of a recruitment manoeuvre, by~     considering its impact on gas exchange, hemodynamics and on the release of systemic~     inflammatory mediators.~   "
190452|NCT01071590|"~     Background:~      - Freezing of gait (FOG) is a common and very disabling symptom in people with Parkinson s~     disease, significantly affecting their quality of life. It has been defined as a sudden break~     or block in the walking motion, or as an inability to start walking. Although certain neural~     connections or neurological processes might contribute to FOG, more research is needed to~     produce consistent findings. Researchers are interested in investigating brain function~     involved in FOG.~      Objectives:~      - To obtain more information on brain function in individuals with freezing of gait.~      Eligibility:~        -  Individuals between the ages of 45 and 80 who have been diagnosed with Parkinson s~          disease.~        -  Participants must be willing to go off their current Parkinson s disease medications for~          up to 12 hours at a time.~      Design:~        -  Participants will be divided into two groups: those who do have freezing of gait (more~          than about once a day) and those who have not experienced this symptom.~        -  The study will involve a screening visit (1 hour) and a study visit (2 hours).~        -  During the screening visit, participants will be asked about medical history, and will~          have physical, neurological, memory, and walking tests.~        -  Participants should not take their Parkinson's disease medications for 12 hours before~          the study visit. Participants who cannot come to the clinic safely without their~          medications will be allowed to stay in the hospital overnight before the visit, and~          should bring their medications to the study in order to take them as soon as needed~          after the study.~        -  Participants will be asked to perform several tasks before the imaging study: (1)~          walking 10 yards back and forth down a hallway, (2) walking 10 yards back and forth~          while following horizontal lines on the floor, (3) walking 10 yards back and forth while~          listening to a metronome, and (4) being pushed back and forth in a wheelchair.~        -  After participants perform the actual tasks, participants will be asked to imagine~          performing the tasks and fill out questionnaires about how well they can imagine the~          tasks.~        -  Participants will be monitored with a functional magnetic resonance imaging (fMRI) scan~          while imagining the four tasks they have just performed.~   "
190453|NCT01071577|"~     Background:~        -  Bone marrow stromal cells (BMSCs) can be grown from bone marrow provided by healthy~          volunteers. Volunteer bone marrow donors for BMSCs are generally required to meet the~          same healthy history and infectious disease marker screening criteria as volunteer blood~          donors. BMSCs are being used to treat a number of immune system and cardiovascular~          disorders, including graft-versus-host disease (GVHD), heart disease, and vascular~          disease. The National Institutes of Health Clinical Center is interested in collecting~          bone marrow aspirates and biopsies from healthy volunteers to produce clinical-grade~          BMSCs to treat Clinical Center patients.~        -  This study will also collect bone marrow from autologous donors (donors who will later~          receive their own BMSCs) for further treatment.~      Objectives:~      - To collect bone marrow aspirates and biopsies from healthy subjects and autologous donors~     in order to produce BMSCs.~      Eligibility:~      - Individuals at least 18 years of age who are either healthy volunteers or individuals who~     will need to receive their own BMSCs.~      Design:~        -  Prospective healthy volunteers will be asked a series of questions designed to identify~          exposure to human immunodeficiency virus (HIV), hepatitis B or C, or other~          transfusion-transmitted diseases. A blood sample will be collected and tested for the~          abovementioned diseases and for other problems that may prevent bone marrow donation.~        -  Prospective autologous donors will also have blood tests to evaluate their own~          suitability for bone marrow donation.~        -  Eligible participants will be scheduled to provide a marrow aspirate/biopsy, taken from~          the upper part of the thigh bone, using standard bone marrow donation techniques.~        -  The collected bone marrow will be processed into BMSCs at the National Institutes of~          Health.~   "
190454|NCT01071564|"~     This phase I trial studies the side effects and best dose of RO4929097 (gamma-secretase/Notch~     signalling pathway inhibitor RO4929097) when given together with vismodegib in treating~     patients with breast cancer that is metastatic or cannot be removed by surgery. RO4929097 may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as vismodegib, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving RO4929097 and vismodegib together may slow the growth of tumor cells and~     may be a more active treatment for advanced breast cancer.~   "
190455|NCT01071551|"~     Childhood socioeconomic status (SES) is related to poor physical health, obesity, elevated~     cardiovascular risk factors and iron deficiency anemia. We plan to offer a comprehensive~     framework allowing the Nutrition Enrichment and Healthy Living Model (NEHLM) among a low~     SES Kindergarten children. The model offered is designed to take into account the current~     economic status of the child's family. We shall conduct a randomized controlled trial to~     assess the efficacy of the intervention.~      Our main objective:~      To compare the influence of the intervention on changes in food consumption, physical~     activity and ,and caries rates in the children in kindergartens where it is applied versus~     the control kindergartens.~      The research hypothesis:~      Integrative Nutrition Enrichment and Healthy Living Model (NEHLM) will improve health~     behaviors among children and parents in comparison to control intervention (physical activity~     only).~   "
190456|NCT01071538|"~     The goals of this pilot study are to gather data about the safety and clinical effect of~     low-dose buprenorphine in older adults with treatment resistant depression.~   "
190457|NCT01071525|"~     1. Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease~          in oxidative stress and a decrease in the atherogenecity in blood samples of the~          patients.~        2. A possible correlation between oxidative stress in hypercholesterolemic patients taking~          niacin to clinical hypercholesterolemia parameters is possible.~        3. Using a novel biomarker will enable a precise detection of the change in the oxidative~          stress in hypercholesterolemic patients.~   "
190458|NCT01071512|"~     The long-term objective is to further establish the role of Tysabri in preventing~     neurological degeneration in multiple sclerosis (MS) and to establish powerful and efficient~     new markers for neurological degeneration in MS. The study intends to correlate cognition~     with two instruments and their measurements-MRI and OCT (optical coherence tomography).~   "
190459|NCT01071499|"~     The purpose of this study is to identify and collect samples from children who have taken a~     single oral dose of the pain medication morphine, and to determine the genetic differences in~     the way children metabolize (break down in the body and how it affects them) morphine.~   "
190460|NCT01071486|"~     Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in~     this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be~     included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be~     investigated using real time PCR. A correlation between pharmacokinetic parameters and~     patients polymorphism will be performed using known statistical technics for comparison. The~     aims of this study are, to correlate the demographic data, clinical presentation, clinical~     outcomes of the included individuals, the BU kinetics and the GST polymorphism and to~     establish an outcome map for those who receive HSCT for their primary disease.~   "
190461|NCT01071473|"~     This application proposes a prospective, single arm feasibility clinical trial of a 12-week~     period of combined endurance and resistance training in survivors of childhood cancer who~     were treated with doxorubicin and/or daunorubicin and have impaired cardiac function.~      Baseline and post intervention imaging, laboratory, and neuropsychological evaluations will~     be used to determine the effects of the intervention on body composition, serum lipid~     profile, exercise tolerance, and neurocognitive functioning. Participants will be called~     weekly to monitor compliance with the intervention. Incentives will be given at intervals~     during the trial to optimize compliance with the intervention.~   "
190465|NCT01071421|"~     The association of sleep apnea-hypopnea syndrome (SAHS) with the infections of the lower~     airway has not been studied. The aspiration of secretions of the upper airway and the~     colonization by microorganisms is considered a main event in most of the cases of community~     acquired pneumonia (CAP) , and specially in the nosocomial pneumonia. The silent aspiration~     to the lower airway is a common phenomenon in normal subjects during the sleep and some~     studies has reported that the patients with SAHS present an increase of the risk to~     pharyngeal aspirations. In fact, the presence of nasal and bronchial inflammation in patients~     with SAHS is a recognized event. The patients with SAHS could have a risk increased to~     develop pneumonia due to predisposition to the pharyngeal microaspiration to lower airways~     during the sleep and other mechanical factors associated. The prevalence of SAHS in patients~     with CAP could be increased as regards the data published for the same Spanish population.~     The presence of an apnea-hypopnea index (AHI) could be a risk factor not only to to CAP but~     to to present a unfavorable clinical evolution in comparison to patients with CAP with a~     normal AHI. The aim of this study will establish a relation between SAHS and the pneumonia~     risk.~   "
190466|NCT01071408|"~     The purpose of this study is to determine whether an outpatient program can reduce the risk~     of recurrent stroke.~   "
190467|NCT01071395|"~     This study will evaluate the responsiveness of a variety of available dyskinesia rating~     scales to treatment with amantadine or placebo in Parkinson's disease patients with~     dyskinesia. The study will be a parallel, double-blind, randomized trial of 68 patients~     treated with amantadine or placebo for 8 weeks. Pre-treatment evaluations will be performed~     and compared to end of study evaluations on the best treatment dose (200 or 300 mg amantadine~     or matching placebo) daily. Safety evaluations will be conducted.~      The responsiveness of the different scales will be evaluated statistically with a mixed model~     in which changes in the outcome measures over time will include a fixed effect of treatment~     group assignment. The model will additionally account for random effects of intercepts (the~     scale scores at baseline) that will include both random variation (person-specific) and~     specific variation associated with rate of change in outcome. The investigators may include~     adjustments for possible confounding covariates, including baseline demographics and center.~     The goal of the program is to provide researchers with the best scale(s) to distinguish~     dyskinesia change in Parkinson's disease (PD) associated with amantadine in comparison to~     placebo and to establish the magnitude of effect achievable with amantadine as a comparator~     gold standard that must be met or surpassed by future anti-dyskinetic agents. Additionally,~     with the use of paper and pencil questionnaires, the study will investigate the impact of~     patient optimism and patient and rater expectation of positive effects on the dyskinesia~     rating outcomes.~   "
190468|NCT01071382|"~     Increasing air travel has resulted in a significant increase in aeromedical evacuation over~     the past decade. However there is only a small amount of epidemiological data available on~     the diagnosis, costs and transport characteristics of aeromedical evacuation cases. In the~     present study Cases of aeromedical evacuation by a relief organization (Workers' Samaritan~     Federation Germany) were analyzed based on the following criteria: age, sex and diagnosis of~     the patient, ventilation mode, days of illness before transport, type of transport, flight~     routes, flying time, flight distance, type of aircraft, type and distance of connecting~     transport from the destination airport to the final hospital, total cost per repatriation,~     and costs per flight-minute of each transport type.~   "
190469|NCT01071369|"~     To study improvements or lack thereof with the interlaminar epidural patients with or without~     steroids experiences mid back, upper back or neck pain with or without chest wall and upper~     extremity pain of at least 6-months duration non-responsive to conservative management.~   "
190470|NCT01071356|"~     A Stage 2 randomized clinical trial (RCT) to test the efficacy of a 9-session model of~     motivational interviewing (MI) for methamphetamine (MA) dependence. Stage 1 pilot testing~     indicated the intervention could be easily learned and implemented with fidelity. The~     tailored treatment approach draws upon our previous conceptual papers on MI as well as our~     experience with a variety of MI protocols, including two Clinical Trials Network (CTN)~     studies of MI. An innovative feature of the Higher Dose Motivational Enhancement Therapy~     manual is that it comprehensively addresses the issues of clients who have achieved sustained~     sobriety as well as those still using substances. Thus, it is designed to facilitate~     treatment entry and engagement as well as maintenance of the gains made in treatment. MA~     dependent clients (N=220) were recruited from New Leaf outpatient treatment in Lafayette,~     California. Study participants were randomly assigned to 1) a single session of Motivational~     Interviewing (MI) plus 8 hours of health/nutrition education, or 2) the intensive 9-session~     MI intervention. In addition to the study interventions, both groups received standard~     outpatient treatment services at New Leaf. Study participants were assessed weekly during the~     first 9 weeks of treatment for MA use. More extensive assessments were conducted at treatment~     entry and 2-, 4-and 6-month follow-ups. Two therapists were crossed to treat clients in~     both conditions. Primary outcome measures included Timeline Follow Back (TLFB) for MA use, MA~     urinalysis results, and retention in treatment. Secondary outcomes include Addiction Severity~     Index scales and the TLFB for alcohol and other drugs. A mediation model will build upon MI~     research proposed by Moyers (2005) and our construct of supportive confrontation by testing~     whether feedback enhanced with warnings about the potential harm of MA use facilitates the~     therapeutic alliance, and whether this in turn facilitates better outcome. Clients with MA~     dependence are good candidates for a more intensive dose of MI because of their severe~     medical and psychosocial problems.~   "
190471|NCT01071343|"~     A growing number of critically ill patients survive intensive care to be discharged from~     hospital. However, critical illness and prolonged bedrest are associated with muscle wasting~     with subsequent implications for recovery of normal physical function. Thus, one year after~     discharge, survivors of septic shock have reported prolonged and severe impairment of~     physical function.~      Early interventions employed in the ICU to counteract loss of muscle mass may potentially~     improve physical outcome and reduce the overall burden of critical illness. As a potential~     supplement to physical therapy, transcutaneous electric muscle stimulation (TEMS) is a~     non-invasive method directed at maintaining skeletal muscle function through artificially~     induced contractions that are independent of patient efforts. TEMS has previously proven~     effective at preventing loss of muscle mass and force in a number of non-ICU patient groups,~     but has only been assessed sparsely in an ICU population where both immobilisation and~     systemic inflammation are present.~      Therefore, the aim of the present study was to assess the effect of early TEMS on muscle~     volume in patients admitted to the intensive care unit with septic shock. The investigators~     hypothesized that this intervention would preserve muscle volume during septic shock.~   "
190522|NCT01070641|"~     Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal~     bleed.~      End points of trial Primary: Variceal hemorrhage Secondary: Death~      Study design~      Randomised controlled clinical trial. Results analysed for the above end points on an~     intention-to-treat basis.~   "
190472|NCT01071317|"~     Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder~     is often not diagnosed and not appropriately treated. The goal of this proposal is to~     determine whether a migraine protocol designed for use in an emergency room can be used to~     deliver the headache care that many migraine patients never receive. This is a randomized~     trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care~     or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the~     following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational~     intervention, reading material, and headache diaries, 3) two migraine specific medications~     and 4) expedited referral to a headache specialist, if needed. Patients in the typical care~     arm will receive whatever intervention the emergency physician feels is most appropriate. We~     intend to enroll 21 patients in each arm of this study for a total of 42 patients. Using~     headache surveys, we will determine if the protocol improves migraine-related pain and~     functional disability one month after the ER visit.~   "
190473|NCT01071304|"~     The purpose of this study is to compare the pharmacokinetic profile of midazolam given alone~     and midazolam given after multiple oral doses of 40 mg ridaforolimus.~      Part 1 of this study is designed for evaluating CYP3A4 activity following 5 days of dosing of~     ridaforolimus and is not designed with efficacy endpoints. Part 2 is a compassionate-use~     extension to give patients an opportunity to receive a clinically active dose of~     ridaforolimus. Part 2 dosing is open ended with limited data collection.~   "
190474|NCT01071291|"~     This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol~     transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion of~     cholesterol.~   "
190475|NCT01071278|"~     The aim of this observational program is to generate data on the use of Tredaptive (nicotinic~     acid/laropiprant) for lipid management under routine medical practice conditions.~   "
190476|NCT01071265|"~     Main Research Questions:~        1. Is a large trial of patients undergoing heart surgery comparing a simple procedure of~          temporarily stopping blood flow to the leg with a blood pressure cuff (called remote~          ischemic preconditioning) to a sham procedure possible?~        2. Does the remote ischemic preconditioning procedure before heart surgery help protect the~          heart and kidneys?~      What is Being Studied:~      A simple procedure known as remote ischemic preconditioning. The procedure is performed by~     inflating a pressurized cuff the thigh to temporarily stop blood flow to the arm or leg. This~     procedure causes the body to have a stress response that, at the cellular level, may protect~     major organs like the heart and kidney from the damage caused to them by the much larger~     stress of cardiac surgery. Reducing this damage may improve patient's recovery after surgery~     and help them live longer.~      Why is this study important?:~      This research is important because up to 1 in every 20 patients that undergo heart surgery~     die before even leaving hospital. Preventing heart and kidney damage at the time of surgery~     with remote ischemic preconditioning may reduce patient deaths.~   "
190477|NCT01071252|"~     The purpose of the study is to determine whether, in patients with moderate to severe~     plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis~     symptoms and the extent to which the patient's body area is affected by the disease (compared~     to placebo).~   "
190478|NCT01071239|"~     The trial proposed is a single arm phase II treatment protocol designed to examine~     engraftment, toxicity, graft-versus-host disease, and ultimate disease-free survival~     following a novel cytoreductive regimen including busulfan, cyclophosphamide and fludarabine~     and anti-thymocyte globulin (ATG- a non-chemotherapy drug whose role is to kill your immune~     system) for the treatment of patients with Fanconi anemia who have severe aplastic anemia~     (SAA), or myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), lacking~     HLA-genotypically identical donors using stem cell transplants derived from (1)~     HLA-compatible unrelated donors or (2) HLA haplotype-mismatched related donors.~   "
190479|NCT01071226|"~     T cell depletion utilizing the CliniMACS device will allow more precise, specific and~     controlled graft engineering of peripheral blood stem cells from unrelated and partially~     matched related donors without an increase in relapse or graft rejection and grade III or IV~     acute graft versus host disease (GVHD).~   "
190480|NCT01071200|"~     The present study was designed to investigate, in hyporesponder subjects, that required in a~     previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH)~     >3500 International Unit (IU), the possibility to decrease through recombinant human~     luteinizing hormone (r-hLH) supplementation, the FSH amount per oocytes retrieved and in the~     mean time to improve the overall cycle outcome.~   "
190481|NCT01071187|"~     The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus~     placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects.~     The main study hypothesis is that subjects treated with varenicline have more abstinent days~     during the study.~   "
190482|NCT01071174|"~     This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety~     of a silicone elastomer vaginal ring containing 25mg dapivirine.~   "
190483|NCT01071161|"~     The purpose of this study is to demonstrate the efficacy of azithromycin to produce a~     significant change in the cough-related health status, measured with the Dutch version of the~     Leicester Cough Questionnaire in patiënts with COPD gold classification 2-4 and chronic~     productive coughing.~   "
190484|NCT01071148|"~     The primary objective of this observational study is to assess the cumulative rate of ongoing~     pregnancy at 10 ±2 weeks after hCG administration in a new series of IVF-treatment cycles in~     a total of 176 subjects, who have undergone three or more previous IVF-treatment cycles~     without live birth. Secondary objectives include subgroup analysis on the effect of age on~     the likelihood of pregnancy at 10 ±2 weeks after hCG administration in a new series of~     IVF-treatment cycles in patients < 35 years and ≥ 35 years, who have undergone three or more~     previous IVF-treatment cycles without live birth.~      The information obtained from this trial will be helpful for subjects who are considering~     further IVF treatments and for IVF centres, as well as for the formulation of governmental~     policies regarding healthcare reimbursement in Norway.~   "
190485|NCT01071135|"~     The purpose of the study is to determine the effect of Quetiapine in patients with~     schizophrenia induced by cannabis abuse.~   "
190487|NCT01071109|"~     A majority of women with breast cancer receive radiation therapy, and many of them experience~     the debilitating side effects of fatigue and insomnia. There is a need for an effective~     treatment that could ameliorate these symptoms and improve quality of life in the radiation~     therapy population.~      The primary purpose of the proposed research is to study the impact of massage therapy as a~     tool for the management of fatigue and insomnia experienced by women diagnosed with breast~     cancer and receiving radiation therapy.~      The secondary purpose is to explain, at the biochemical level, the effect of therapeutic~     massage on the level of fatigue and insomnia in radiation therapy patients. Prior studies~     have shown an association between fatigue and insomnia in the breast cancer patient following~     radiation therapy and the presence of inflammation as evidenced by increased proinflammatory~     cytokine production. The investigators hypothesize that therapeutic massage will ameliorate~     the symptoms of fatigue and insomnia associated with radiation therapy, and will be~     associated with a reduction in the plasma levels of interleukin-6 (IL-6),soluble IL-6~     receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). This reduction in proinflammatory~     biomarkers will be due to the activation of the cholinergic anti-inflammatory pathway via the~     activation of the vagus nerve.~   "
190488|NCT01071096|"~     Twenty patients will be enrolled in a 2-site, 7-month, double-blind study conducted to~     evaluate a reduction in headache days and attacks and calcitonin gene-related peptide (CGRP)~     levels in saliva following treatment with OnabotulinumtoxinA versus saline.~      Eligible patients will be randomized and receive injections of OnabotulinumtoxinA or Saline~     at Visit 1. Following 3 months plus a 1 month wash out, patients will receive cross-over~     injections at Visit 5.~      Patients will return for monthly visits and exit the study at Visit 8.~      Patients will collect saliva at monthly intervals and document in a daily headache diary~     throughout the study .~   "
190489|NCT01071083|"~     This is a randomized, rater blinded trial in patients who interrupt treatment with~     natalizumab with or without being treated with other immunomodulatory drugs, or continue~     treatment with natalizumab.~      The main purpose of this study is to find out the following, when participants stop taking~     natalizumab for 24 weeks:~        -  when MS symptoms return, and~        -  if other drugs for MS may help control MS symptoms during the natalizumab-interruption~          period.~      This study will also explore how quickly the effects of natalizumab return after resuming~     natalizumab dosing.~   "
190490|NCT01071070|"~     Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in~     Chronic Kidney Disease~   "
190491|NCT01071057|"~     The purpose of this study is to improve how we treat itching, a common side effect associated~     with the use of morphine pain medication. Itching is a problem experienced by up to 30% of~     the children treated with pain medications in the morphine family.~      Despite studies demonstrating the effectiveness of using naloxone to treat itchiness in~     adults receiving morphine pain medications, there are not many studies in children. This~     study is designed to study how well naloxone works for treatment of itching in children~   "
190492|NCT01071044|"~     Over the past decade, the Rochester Center for Behavioral Medicine (RCBM) has evaluated many~     patients with attention deficit hyperactivity disorder (ADHD). A recurrent finding in these~     patients is a history of unexplained fatigue and musculoskeletal pain.~      Treatment of these patients in our clinic has revealed that when their underlying ADHD is~     treated with psychostimulant medication, many patients report significant improvements with~     regard to their fatigue and musculoskeletal pain. Patients report less subjective fatigue and~     pain and note overall functional improvement, although the initial and primary objective was~     the treatment of their attention or hyperactivity problems. We speculate that stimulants are~     efficacious by offering two distinct clinical properties. 1) anti-fatigue properties and 2)~     properties that allow patients to filter out extraneous stimuli (i.e. chronic muscle pain).~   "
190493|NCT01071031|"~     The purpose of the study is to see whether a single vaccination (injection) with the~     investigational HIV vaccine is safe and effective in patients who are HIV positive but have~     not yet begun anti-retroviral therapy. As this is an exploratory study, four different dose~     formulations of HIV vaccine will be investigated.~      This study will evaluate whether or not the HIV vaccine is able to reduce the HIV viral load~     (number of HIV virus particles in the blood) and increase or slow the decline in CD4 T cell~     count.~   "
190494|NCT01071018|"~     This study is designed to evaluate the safety and tolerability, pharmacokinetics,~     pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day~     (QOD) and Once Weekly (QW) dosing schedules.~   "
190495|NCT01071005|"~     The primary objective of this study is to examine, in healthy subjects, the comparative~     pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical~     Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott~     Laboratories Ltd, through the strength of biological markers follicle stimulating hormone~     (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the~     substance.~      Secondarily be observed safety (tolerability) of subjects in clinical research through the~     comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse~     events.~   "
190496|NCT01070979|"~     Multicenter, double-blind, controlled, parallel group, randomized study to compare the~     clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine~     estrogen tablets, each administered orally, once daily, to postmenopausal women.~   "
190497|NCT01070966|"~     This survey is conducted for preparing application material for re-examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the~     clinical usefulness of VYTORIN through collecting the safety and efficacy information~     according to the Re-examination Regulation for New Drugs.~   "
190498|NCT01070953|"~     This survey is conducted for preparing application materials for re-examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the~     clinical usefulness of EZETROL® through collecting the safety information according to the~     Re-examination Regulation for New Drugs.~   "
190499|NCT01070940|"~     The purpose of this study is to investigate the effect of different levels of nitric oxide~     inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor~     of the nitric oxide synthase, is administered as bolus injection followed by continuous~     infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA~     dose.~   "
190501|NCT01070914|"~     Primary Ciliary Dyskinesia (PCD) is a severe genetic disorder caused by various mutations in~     genes affecting ciliary motility. Various new and complementary diagnostic techniques,~     including measurements of nasal nitric oxide (NO), Video Microscopy (VM), Immunoflourescence~     (IF) and genetic analysis have recently been recognized as simpler and more accurate~     modalities for the diagnosis and characterization of patients with PCD compared to electron~     microscopy. While considered a rare disease worldwide, PCD is more prevalent among highly~     consanguineous populations, such as those found in Israel. We hypothesize that using modern~     state of the art and novel test modalities on a national scale in Israel will improve~     diagnosis, improve phenotypic-genotypic correlations and create a national registry for PCD.~   "
190502|NCT01070901|"~     Immunosuppressive therapy protocols in solid organ transplantation are rudimentary, differ by~     transplant center and no practical strategies are available to guide an individuals' response~     to immune suppression. In this study we will conduct research to assess immunologic status in~     solid organ transplant recipients, predicting immune reconstitution and outcomes after~     transplant to better guide the use of immunosuppressive medications.~   "
190503|NCT01070888|"~     The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new~     combination asthma medication, is more effective than budesonide alone in controlling~     exercise induced asthma.~      The investigators hypothesize that in children and adults who suffer from asthma and exercise~     induced asthma there will be less decline in lung function associated with exercise when they~     receive the study medication.~   "
190504|NCT01070875|"~     This study is designed to assess the incidence of abnormal partial thromboplastin time in~     patients receiving unfractionated heparin (UFH) 5000 U 2 times a day versus 3 times a day.~      The basic hypothesis of this study is that patients receiving UFH 5000 U subcutaneously 3~     times a day will have a higher proportion of elevated partial thromboplastin time than~     patients receiving UFH 5000 U subcutaneously twice a day.~   "
190505|NCT01070862|"~     The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line~     treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone~     before autotransplant, and in elderly patients in combination with conventional chemotherapy~     and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.~   "
190506|NCT01070849|"~     Background:~      In chronic back pain, rehabilitation specific aftercare programs, needed for a long-term~     improvement of pain and functional ability, are absent. Purposeful and differentiated~     aftercare treatments offer the possibility, in particular in the rehabilitation of chronic~     back pain, to increase the sustainability of positive effects of a mostly three weeks taking~     rehabilitation or to intensify them.~      Hypothesis:~      The implementation of a developed bio-psycho-social aftercare intervention program for CLBP~     (RÜCKGEWINN) leeds to a better rehabilitation outcome in comparison to current usual~     aftercare (IRENA) and a control group in view of pain-conditioned functional ability and back~     pain episodes.~      Methods/Design:~      A multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants~     will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to~     either one of the three study arms. Outcomes are measured before and after rehabilitation and~     twelve month after dismissal form rehabilitation into the aftercare program.~   "
190507|NCT01070836|"~     The primary objective of this study is to demonstrate that the incidence of progressive~     multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have~     detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in~     participants who have detectable antibodies to JCV (antibody positive).~      The secondary objectives of this study are to: Estimate the incidence of PML in~     natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody~     positive, based on a meta-analysis of data obtained from this study and other data sources;~     Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) participants~     receiving natalizumab within the TYSABRI Outreach: United Commitment to Health (TOUCH)~     Prescribing Program; Determine changes in anti-JCV antibody status over time.~   "
190508|NCT01070823|"~     The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing~     multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for~     such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay~     in a plasma matrix and to determine changes in anti-JCV antibody status over time.~   "
190509|NCT01070810|"~     The major goal of this project is to determine whether the use of thiamine in patients with~     septic shock will result in attenuation of lactic acidosis and a more rapid reversal of~     shock.~   "
190510|NCT01070797|"~     Patient's on this protocol have a type of blood cell cancer, other blood disease or a genetic~     disease and have received a stem cell transplant. The donor of the stem cells was either a~     brother or sister, another relative, or a closely matched unrelated donor. The patient is~     being asked to participate in this study which tests if blood cells from the donor that have~     been grown in a special way, can prevent or be an effective treatment for early infection by~     three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) and adenovirus.~      Adenovirus is a virus that usually causes symptoms of a common cold, but can cause serious~     life-threatening infections in patients who have weak immune systems. It can affect the lungs~     and cause very serious pneumonia, and can also damage the gut, liver, pancreas and eyes.CMV~     can also cause serious infections in patients with weak or suppressed immune systems. It~     usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut,~     the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body.~     In healthy people CMV rarely causes any problems because the immune system can keep it under~     control, but after a transplant, the risk of developing CMV disease is much higher because~     the immune system is so weak. EBV is the virus that causes glandular fever. It is also a life~     long infection like CMV that is normally controlled by the immune system. When immunity is~     weak, the virus can become active and cause fevers, enlarged lymph nodes and sometimes a type~     of cancer called lymphoma.~      Investigators want to see if a kind of white blood cell called T lymphocytes (T cells)can be~     used to prevent and treat adenovirus, CMV and EBV in the early stages of reactivation or~     infection. T cells have been grown from the patient's stem cell donor in the laboratory in a~     way that will train them to recognize the virus and control it when they are given after a~     transplant. This treatment with specially trained T cells (also called CTLs) has had activity~     against these viruses in previous studies and in this study investigators want to see if they~     still have activity when they are made in a simpler and faster way. These donor-derived~     multivirus-specific special cell lines are an investigational product not approved by the~     Food and Drug Administration.~      The purpose of this study is to evaluate whether donor-derived multivirus-specific special~     cell lines are safe and can control three viruses: EBV, CMV and adenovirus.~   "
190511|NCT01070784|"~     The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler~     compared to standard COPD treatment during one year in Japanese patients with COPD.~   "
190536|NCT01070459|"~     This study aims to investigate the effect of aerobic exercise on the aerobic capacity, the~     daily functioning, post-stroke fatigue , depression and cardiovascular risk factors in stroke~     patients.~   "
190512|NCT01070771|"~     The use of coronary angiography to investigate patients at risk of coronary artery narrowings~     has become universal. In most cases, this investigation leads to a successful treatment plan~     with revascularisation recommended where appropriate. However in a substantial number of~     patients, the images taken of the coronary arteries can lead to diagnostic uncertainty.~     Increasingly, doctors are using devices called pressure wires to clarify the significance of~     coronary artery narrowings in order to tailor patient treatment on an individual basis.~      The Radi pressure wire is well recognised as a reliable tool in assessing whether a narrowing~     is significant in functional terms, that is, does it significantly restrict blood flow to the~     heart muscle.It consists of a fine wire that is fed into individual major coronary arteries~     to measure pressure within the vessel itself. In conjunction with the images taken of the~     arteries, it is very useful in deciding how best to treat patients.~      This study enrolls volunteers who are being investigated for stable cardiac-sounding chest~     pain and are undergoing a coronary angiogram. It will investigate whether the extra~     information gained from pressure wire assessment will change patients' treatment plan.~   "
190513|NCT01070758|"~     The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in~     children with congenital hyperinsulinism already treated with Octreotide by pump.~      Congenital hyperinsulinism is a genetic disorder characterized by inappropriate insulin~     secretion resulting in persistent hypoglycemia (low blood sugars. Patients exposed to~     recurrent hypoglycemic episodes are at increased risk of developmental disorders, so~     identification and prompt management of patients are essential. Many patients are treated~     with the somatostatin analog Octreotide which is administered by continuous infusion using a~     pump (we use an insulin pump). This treatment may pose a huge burden and be stressful for~     patients and families as it demands intensive daily care. In an effort to simplify the daily~     care of our patients and improve their quality of life we will study the efficacy and safety~     of Lanreotide Autogel - a long-acting somatostatin analog that can be administered by~     injection once a month~   "
190514|NCT01070745|"~     Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation,~     however persistence of ductal patency postnatally may have significant adverse hemodynamic~     effects in the neonate. Medical therapy for PDA predominantly involves the administration of~     one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these~     therapies have been shown to be successful in mediating ductal closure in approximately 70%~     of treated infants.~      However, the need for a second course of treatment for PDA closure remains quite common. The~     investigators hypothesize that, because of small differences between the two drugs, a greater~     percentage of infants who did not respond to a first course of therapy with indomethacin will~     respond to a second course with ibuprofen than to a repeat course of indomethacin.~      As such, the investigators aim to compare secondary therapy with a repeat course of~     indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent~     after a first course of therapy with indomethacin.~   "
190515|NCT01070732|"~     The present study is aiming to unravel the clinical efficacy of intravenously administered~     paracetamol as antipyretic and analgesic medication in various medical conditions.~   "
190516|NCT01070719|"~     This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed~     to assess the biochemical, immunological and pharmacokinetic profiles of a large, actively~     infusing natalizumab patient population. A duration effect for progressive multifocal~     leukoencephalopathy (PML) risk associated with natalizumab therapy appears to exist. There is~     minimal data available to understand this effect at the biochemical and cellular level. The~     purpose of this study is to gather preliminary data on several parameters to guide in more~     focused research on the duration effect.~   "
190517|NCT01070706|"~     Phase Ib part:~      ▪ Primary objective: To demonstrate the recommended dose of the combination of paclitaxel,~     gemcitabine, and sunitinib (sutene®) (PGS) as preoperative chemotherapy in patients with~     HER2-negative operable breast cancer~        -  Secondary objective:~             1. To demonstrate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of~               this regimen~             2. To determine the safety profile~                Phase II part~        -  Primary objective:~      To evaluate the pathologic complete response rate (pCR) to preoperative administration of PGS~      ▪ Secondary objective:~        1. To assess breast conserving rate after preoperative PGS~        2. To evaluate clinical response rate, disease free survival (DFS), and overall survival~          (OS)~        3. To assess the safety profiles of PGS~   "
190518|NCT01070693|"~     This randomised prospective study was designed to compare the convalescence and the long-term~     sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene~     Hernia System®) or an onlay mesh applied according to Lichtenstein.~   "
190519|NCT01070680|"~     In this pilot prospective non-commercial clinical trial the investigators will study the use~     of dexmedetomidine as an adjuvant to the patient-controlled propofol sedation in a~     placebo-controlled and randomized manner in patients with drug addiction during Endoscopic~     Retrograde Cholangiopancreatography (ERCP). Dexmedetomidine is a sedative medication used~     mostly in intensive care units,and is marketed under the brand name Precedex. Dexmedetomidine~     has sedative, analgesic, sympatholytic, and anxiolytic properties. It produces sedation~     without causing significant respiratory depression. Recent research has suggested~     dexmedetomidine to be effective in treatment of alcohol withdrawal signs. In previous studies~     dexmedetomidine was insufficient as an only sedative agent in ERCP and colonoscopy, but it~     has not been assessed for sedation in patients with chronic pancreatitis. The main objective~     of this trial is to evaluate if dexmedetomidine can reduce propofol and opioid consumption~     and facilitate the performance of ERCP in patients with chronic pancreatitis due to drug~     addiction.Secondary objectives of the trial are the stability of vital signs and safety,~     patients´ satisfaction plus recovery time from sedation.~      50 elective ERCP patients with chronic pancreatitis after written informed consent and~     randomisation will be recruited to the study. Exclusion criteria are:allergy to propofol,~     opioid or dexmedetomidine, ASA class greater than 3. All the patients will receive~     patient-controlled propofol sedation. In dexmedetomidine group dexmedetomidine infusion will~     be started before sedation beginning and in placebo group placebo-solution (NaCl0,9%) will be~     administered in the similar manner.Standard monitoring for vital signs will be applied,also~     sedation degrees will be evaluated with sedation scores. At the end of procedure total amount~     of propofol and opioid will be calculated,patients and endoscopists satisfaction and the~     difficulty of ERCP will be assessed.~   "
190520|NCT01070667|"~     The purpose of this study is to accurately investigate the efficacy of dronedarone in~     maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation~     as compared with placebo. This has never previously been performed using pacemaker Holter~     monitoring which provides detailed information of atrial arrhythmia patterns the entire study~     period. Additionally detailed patient symptom self assessment and questionnaires will be~     collected. The study design will be double blinded crossover with each phase lasting 3~     months.~   "
190523|NCT01070628|"~     The purpose of this study is to confirm that the dose levels and dosing frequency utilising~     the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it~     is anticipated that when lower dose of Stalevo is administered after the first higher dose of~     Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after~     each dose throughout the day compared to Cmax after the first dose.~   "
190524|NCT01070615|"~     Objectives: Evaluation of the clinical long-term safety, tolerability, patient satisfaction,~     pharmacokinetics and pattern of use of oral prucalopride tablets given in doses up to 4 mg~     once daily to patients with chronic constipation~   "
190525|NCT01070602|"~     Intraoperative Floppy Iris Syndrome (IFIS) may occur during cataract surgeries in patients~     treated with alpha 1 blockers. IFIS related to alpha 1 blocker Tamsulosin (used for prostate~     hypertrophy) was reported in 50-90% of patients. IFIS during surgery make the surgery more~     difficult and raise complication rate.~      Using anterior corneal incisions was reported briefly in literature as a prophylactic means~     but was not studied prospectively. we believe (according to our clinical experience) that~     these anterior incisions do help to reduce the incidence and severity of IFIS signs and~     complications rate during surgeries.~   "
190526|NCT01070589|"~     The aim of the present study is to asses the effect of obesity on anaerobic exercise's growth~     hormone (GH) response.~   "
190527|NCT01070576|"~     Objective: Primary objective is to study the arginine-NO metabolism during fracture healing~     and dysfunctional fracture healing. Secondary objective: to investigate if differences or~     decreased arginine and NO concentrations in bone healing form a prognostic marker for~     non-union development Hypothesis: Early detection of disturbances in the Arginine and nitric~     oxide metabolism during fracture healing are a good prognostic marker for non-union~     development.~      Study design: Prospective observational study. Study population: All acute fracture patients~     (age >18 years), with a fracture of the tibia or femur attending the Department of General~     Surgery, to investigate the Arginine -NO metabolism during normal fracture healing and~     possible dysfunctional healing. In total 100 patients will be included during this study.~      Main study parameters/endpoints:~      Primary endpoints are arginine and Nitric Oxide levels in the plasma during normal and~     dysfunctional fracture healing the bone in patients with and without non-union Secondary~     endpoints are levels of Nitric Oxide citrulline, ornithine and other amino acids in bone and~     in plasma Other parameters: baseline demography details will be obtained, including possible~     confounders, such as bodyweight, smoking, alcohol abuse, which may interfere with the outcome~     of this study.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The extent of the burden and risk associated with participation is expected to~     be low during this study. In total, 7 blood samples will be taken during this study (45ml, in~     total). During the primary (and possible secondary) surgical procedure, bone debris will be~     taken. Bone debris is usually discarded but will be used for analysis in this study. There is~     no extra surgical procedure necessary to obtain the bone debris.~   "
190528|NCT01070563|"~     In France the diagnosis of brain death relies on electroencephalography (EEG) or cerebral~     angiography. Concerning the latter a time of 6 hours is mandatory between the clinical~     diagnosis and the realization of the cerebral computed tomography (CT) angiography.~     Transcranial doppler (TCD) is not recommended in the french guidelines for the diagnosis of~     brain death. In other countries, some flow patterns allow to confirm the diagnosis of brain~     death. The hypothesis of our study is that TCD could shorten the time between the clinical~     diagnosis of brain death and the realization of the CT angiography.~   "
190529|NCT01070550|"~     This observational study will assess predictors of early on-treatment and sustained~     virological response in treatment-naïve patients with chronic hepatitis C initiated on~     treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during~     the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target~     sample size is <5000.~   "
190530|NCT01070537|"~     The Bonfils intubation fiberscope (BF), a rigid medical device with a curved tip, is~     exclusively used in anesthesiology for orotracheal intubation (OTI). The objective of the~     study was to evaluate the feasibility and the tolerance of an intubation procedure realized~     by means of the BF (BFI) in awake adult patients with predicted difficult intubation (PDI),~     in the context of ENT cancer surgery.~      The intubation is performed under local anesthesia (either nasal, oral, or~     intercricothyroidal) and sedation using Remifentanyl (AIVOC) with spontaneous ventilation.~     The primary endpoint is the rate of BFI meeting quality requirements: the procedure must be~     both successful (≤ 2 attempts and duration < 180 sec) and well tolerated (Fahey score < 2).~     The secondary endpoints include the difficulties met by the operator during the BFI and~     patient's perception of the intubation procedure, evaluated in the recovery room and 7 days~     after the intervention. Sample size is calculated using a one-stage Fleming design with~     p0=80%, p1=95%, alpha=5% and 80% power, for a total of 32 evaluable patients.~   "
190531|NCT01070524|"~     Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188~     pMDI qd in adult patients with persistent asthma~   "
190532|NCT01070511|"~     Summary for Patients: This study, funded by the Muscular Dystrophy Association, is intended~     to build on recent findings published in the journal Nature showing beneficial effects of~     tadalafil (also known as Cialis) in mice with an animal version of Duchenne and Becker~     muscular dystrophies. Only two doses of tadalafil improved muscle blood flow, allowing the~     dystrophic mice to perform more exercise with less muscle injury. This new short-term~     clinical trial will move the testing from animals to human patients with Becker muscular~     dystrophy and examine the effects of acute tadalafil dosing on muscle blood flow during a~     bout of exercise. Patients will take two doses of tadalafil prior to exercising. Then doctors~     will measure whether muscles receive increased blood flow and therefore are better protected~     during exercise.~      Scientific Hypothesis: In patients with Becker muscular dystrophy (particularly those with~     dystrophin gene mutations between exons 41-46), loss of sarcolemmal nitric oxide synthase~     engenders functional muscle ischemia and thus muscle edema after an acute bout of exercise.~     The investigators further hypothesize that PDE5A inhibition, which boosts nitric oxide-cGMP~     signaling, constitutes an effective new countermeasure for these patients.~   "
190533|NCT01070498|"~     The goal of this study is to determine whether Trichuris suis ova, a potential~     immunomodulator, is safe in adults and children allergic to peanut or tree nuts.~   "
190534|NCT01070485|"~     The purpose of the study is to investigate if multiple (up to four) intravenous injections of~     Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer~     patients with bone dominant disease who have progressed on endocrine therapy and are no~     longer considered suitable for endocrine therapy. In addition the safety of Xofigo~     (Alpharadin) will be assessed.~   "
190535|NCT01070472|"~     The purpose of this study is to determine whether a titrated solution of oral Misoprostol is~     safe and effective at inducing labor at term, regardless of Bishop Score.~   "
190537|NCT01070446|"~     Cystic fibrosis (CF) is the most common lethal, inherited disorder among Caucasians. Choline~     is an essential vitamin and as a methyl donor is critically needed to support the normal~     metabolism. Our previous studies have demonstrated that children with CF have depleted levels~     of choline. The purpose of this study is to supply a choline supplement to children with CF~     to see if their nutrition and methyl status can be improved.~   "
190538|NCT01070433|"~     The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment~     of subjects with diabetic foot ulcers (DFUs).~   "
190539|NCT01070420|"~     The purpose of this study is to evaluate the safety and effectiveness of the peripheral IV~     continuous infusion without the insertion of central venous vascular access method in the~     achievement of steady-state maximal coronary hyperemia compared with the central IV~     continuous infusion method.~   "
190540|NCT01070407|"~     HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine~     against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by~     intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin~     respectively, bearing the same genetic information for HCV antigens (NS region).~      The two recombinant vectors, called Ad6NSmut and AdCh3NSmut, are weakened and unable to~     multiply within the body; they are designed to induce an immune response against HCV~     proteins. Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial,~     promising results have been obtained in non-human studies.~      The HCV001 study is designed to explore different prime-boost regimes concerning dose, order~     and interval of administration of Ad6NSmut and AdCh3NSmut.~   "
190541|NCT01070394|"~     The purpose of this study is to examine the effectiveness and length of effect of Vyvanse on~     lessening Attention-Deficit/Hyperactivity Disorder symptoms in adults. The study will also~     investigate the safety and tolerability of Vyvanse in adults with ADHD.~   "
190542|NCT01070381|"~     The purpose of this study is to investigate the subjective and objective performance of two~     daily disposable lenses for wearers with astigmatism.~   "
190543|NCT01070368|"~     Nowadays, commercial wheat extract is widely accessible, and is used for skin prick test for~     wheat allergy. However, commercial wheat extracted for skin prick test have less precise test~     result compared to extract from omega-5 gliadin, which is one of the major allergen with~     immediate wheat allergy.~   "
190544|NCT01070355|"~     Eicosapentaenoic acid (EPA) is a naturally occuring omega-3 polyunsaturated fatty acid found~     in oily fish. EPA has anti-colorectal (bowel) cancer activity in experimental models. This~     trial will test whether EPA reduces markers of tumour growth, and is safe and well~     tolerated,in patients with colorectal cancer liver metastases awaiting surgery.~   "
190545|NCT01070342|"~     Ambulatory Blood Pressure Monitoring (ABPM) potentially offers a superior way to screen~     children for entry into antihypertensive trials, assuring that only those with true~     hypertension are enrolled.10 In addition, ABPM offers a better method to measure response to~     drug therapy.11-16 The ABPM device most commonly used in children (Spacelabs 90217 -~     Issaquah, Washington) has not been independently validated for use in this population. In~     1993, the British Hypertension Society (BHS) published a protocol for validating ABPM~     devices, including guidance for validation studies in children.17 More recently, the Working~     Group on Blood Pressure Monitoring of the European Society of Hypertension published~     revisions to these guidelines, but did not include children in this update.18 Unfortunately,~     the original BHS protocol suggests using a smaller group of children than the protocol~     outlines for adults. Since BP in children is more variable than in adults, this guidance is~     unlikely to be adequate for children. Hence, a large, stringent validation study needs to be~     conducted in a cohort of children using the methods similar to those used to validate the~     device in adults. Performance of the proposed validation study is needed to allow for the~     incorporation of ABPM into clinical trial designs of anti-hypertensives in children which~     will ultimately allow for more accurate identification of the hypertensive population and~     determination of response to therapy along with allowing for assessment of the chronobiologic~     profile of drug response over the dosing interval.9~   "
190546|NCT01070329|"~     The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for~     8 weeks to patients diagnosed with major depressive disorder, who also report associated~     painful physical symptoms, is better than placebo when treating depression and its associated~     painful symptoms.~   "
190547|NCT01070316|"~     The goal of this study is to learn if the study drug RAD001 can reduced the number of~     epileptic seizures, and can be taken safety by people who have epilepsy associated with~     Tuberous Sclerosis Complex.~   "
190548|NCT01070303|"~     The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term~     maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate~     the long-term safety of adalimumab when administered to participants with Crohn's disease.~   "
190549|NCT01070290|"~     This will be a multi-center, open-label randomized phase 2 study designed to evaluate the~     progression free survival (PFS) of patients with advanced gastric cancer following treatment~     with either ARQ 197 or one of three standard regimens (investigator's choice). Patients with~     unresectable (locally advanced or metastatic) gastric carcinoma who have progressive~     neoplastic disease following treatment with a prior regimen consisting of at least two of the~     drugs 5-FU, cisplatin and docetaxel. The study will also evaluate other efficacy and safety~     parameters including overall response rate, overall survival and adverse events in the two~     treatment arms.~   "
190550|NCT01070277|"~     Study hypotheses is that Antiparasitic therapy in patients with chronic diarrhea after travel~     to a developing country, with a negative stool findings, will be significantly effective in~     eliminating diarrhea and other gastro-intestinal complaints compared to similar patients~     receiving placebo.~   "
190551|NCT01070264|"~     Tahitian Noni Juice (TNJ) made from Morinda citrifolia (noni) fruits may provide a safe~     adjunctive treatment for osteoarthritis (OA) due to its anti-inflammatory and analgesic~     properties. In this study the investigators examined whether TNJ was able to improve the~     symptoms and quality of life (QOL) of OA patients. The investigators also sought to evaluate~     the tolerability and safety of TNJ.~      This was an open label three-month intervention pilot study. Data were collected by pre and~     post intervention survey as well as laboratory testing. Inclusion criteria were: adults of~     both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care~     physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a~     day.~   "
190554|NCT01070225|"~     Current therapies for the management of asthma include inhalers. Types of these medications~     (beta agonists), improve asthma symptoms by stimulating areas (receptors) within the human~     airway resulting in dilation of the human airway. Whilst these drugs are highly effectively~     in the immediate setting their longterm use, constantly stimulation of receptors within the~     airway has been associated with increased asthma exacerbations and rare cases of death.~      Conversely medications that block receptors within the human airway (betablockers)have been~     avoided in asthma.~      The main reason for this is because of the possible acute airway narrowing that can occur~     after soon after administration. However chronic use of betablockers in asthma has recently~     been shown to be of benefit in reducing airway inflammation which is of great importance in~     improving asthma control and reducing symptoms.~      Despite this early evidence supporting chronic use of beta blockers in asthma, there is~     concern in 2 major regards:their potential to cause acute airway narrowing (irrespective of~     longterm benefit) and the possibility that they could block the reliever action of beta~     agonists.~      The objective of this study is to establish how best to reverse the short term effects of a~     single dose of beta blocker.~      This study is designed as a single centre study, with participants attending the department~     on approximately 3 separate visits (including a screening visit) at approximately 1 weekly~     intervals.~   "
190555|NCT01070212|"~     One obvious property difference between energy-yielding beverages and solid foods is the oral~     mechanical processing required to prepare the two food forms for swallowing. Considerable~     human data are consistent with a contribution of mechanical stimulation to appetite~     suppression. However, no study has isolated this property and assessed its influence on~     ingestive behavior in humans. This is the aim of the present study. The null hypothesis is~     that food rheology will have no effect on these indices. The alternate hypothesis is that~     increased mechanical stimulation will result in stronger satiation/satiety and reduced energy~     intake. Further, it is hypothesized that the effects of mastication will be less evident in~     obese compared to lean individuals.~   "
190556|NCT01070199|"~     Energy-yielding fluids induce weaker appetitive and compensatory dietary responses than~     energy-matched semi-solids or solids. This is problematic because the high and increasing~     contribution of energy from beverages in the diet may enhance positive energy balance and~     weight gain. The prevailing view of the overweight/obesity problem is that it stems from a~     small, sustained positive energy balance. It follows then that only small changes, perhaps~     manipulations in the rheological characteristics of the diet, will be required to correct the~     problem. Certain populations that are more prone to weight gain may benefit from such~     manipulations. Obese individuals have a higher beverage intake and experience greater weight~     loss with reductions in beverage intake. Further, there is evidence that obese individuals~     consume more energy after a liquid pre-load than their lean counterparts, yet there is no~     difference in energy intake after a solid load. In contrast, habitual exercisers have been~     shown to have an increased accuracy of short-term regulation of food intake at meals~     following liquid preloads. A better understanding of the mechanisms by which beverages and~     energy-matched solid food forms elicit differential appetitive and dietary responses in these~     populations needed. This research will attempt to identify the influence of physical fitness~     and body fat on the ability to compensate for the energy content of solid and liquid preloads~     by reduction in energy intake at a subsequent ad libitum meal (i.e., acute compensation) and~     over the course of the day (i.e., short-term compensation). Furthermore, this study will~     examine the cognitive contribution to differential responses to energy-matched beverage and~     solid food forms and the effects of mastication on appetite, GI transit, glycemic response,~     and selected endocrine responses.~   "
190557|NCT01070186|"~     This study is designed to explore the molecular modulatory effect of Sunitinib when given in~     a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate~     aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery~     2-4 weeks following the last dose.~   "
190558|NCT01070173|"~     The investigators hypothesize that low serum ghrelin levels may characterize a group of~     patients with poor weight gain and/or linear growth who do not have any other identified~     cause for growth failure. These patients may present with a variety of complaints and are~     often evaluated by both pediatric endocrinologists and pediatric gastroenterologists. The~     investigators hypothesize that ghrelin has a physiologically important role in linear growth~     and that chronic diseases of the gastrointestinal system, such as H. Pylori infection or~     celiac disease, may alter serum ghrelin levels in children. Low ghrelin levels may be a~     factor leading to poor growth, potentially by altering growth hormone secretion and/or by~     decreasing appetite. By measuring ghrelin levels in children with short stature and in~     children with gastrointestinal disease, the investigators will further elucidate the possible~     physiologic role of ghrelin in childhood growth and how it may be altered in conditions~     causing short stature and in certain gastrointestinal diseases.~   "
190559|NCT01070160|"~     The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal~     women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at~     the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with~     Metformin. We propose that improving insulin sensitivity with use of Metformin in women~     diagnosed with PCOS has facilitatory influences on the uterine endometrium.~   "
190560|NCT01070147|"~     The primary goal of this study is that the combination of a computerized asthma reminder~     system with implementation of an guideline will increase utilization and adherence of~     guideline-driven care, leading to improved patient outcomes.~      Hypothesis: An automatic, computerized reminder system for detecting asthma patients in the~     pediatric ED will increase guideline adherence compared to paper-based guideline.~      The specific aims of the study are:~      Aim 1: Develop, implement, and integrate the asthma guideline in the ED information system~     infrastructure.~      Aim 2: Evaluate the effect of the asthma detection system combined with the computerized~     guideline versus the asthma detection system combined with the paper-based guideline.~   "
190646|NCT01068990|"~     This study is a prospective observation study for lower respiratory tract infections in~     medical intensive care unit. Microbiologic and clinical characteristics and outcomes of~     patients with severe pneumonia in medical intensive care unit will be monitored and analyzed.~   "
196694|NCT00988767|"~     The purpose of this study was to investigate whether HBV-DNA vaccination is safe and could~     restore immune responses in patients with chronic hepatitis B non responder to available~     therapies.~   "
190561|NCT01070134|"~     Background:~      According to the WHO, major depressive disorder is the second largest healthcare problem~     worldwide in terms of disability caused by illness. It afflicts an estimated 17% of~     individuals during their lifetimes at tremendous costs. A number of depressive patients are~     treated with antidepressant medication. The efficacy of antidepressant medication has been~     studied in a number of systematic reviews, and in recent years some of these reviews have~     shown that the efficacy is questionable for many patients. So are there other effective~     treatments for this serious illness?~      Cognitive- and psychodynamic therapies are probably both significantly more effective for~     depression than no treatment, but only limited comparisons have been made between the two~     interventions. A Cochrane review shows that cognitive therapy has a preventive effect against~     recurrent depression, and that this effect may surpass the preventive effect of~     antidepressant medication. Mindfulness training may be an effective technique in preventing~     relapse in patients who have had at least 3 previous depressive episodes. But efficacy in~     treating currently depressed patients has not been studied.~      Objective To perform a randomised clinical trial with blinded assessment of efficacy~     variables in order to study the effects of mindfulness based behavioral therapy (cognitive~     therapy and mindfulness) versus psychodynamic therapy in depressive patients.~      Methods~      A randomised clinical trial of 84 consecutive patients diagnosed with major depressive~     disorder, referred to the day clinic, Roskilde psychiatric services. The patients will be~     randomised to one of two interventions:~        1. MIBT (mindfulness-based behavioural therapy)~        2. PT (psychodynamic therapy)~   "
190562|NCT01070121|"~     To stimulate collaborative efforts of federal funding agencies, voluntary health agencies,~     professional organizations and industry partners to enable creation of a large, sustainable~     database and repository to better understand the molecular basis of treatment and rapidly~     accelerate translational research in RA.~   "
190563|NCT01070108|"~     Ketamine affects postoperative pain when administered intravenously immediately before,~     during or at the end of surgical procedures. We assessed the effects of multiple and~     escalating doses of ketamine administered many hours before surgery on postoperative pain and~     analgesia consumption.~   "
190564|NCT01070095|"~     Asthma is a common and potentially fatal chronic disease. An asthma action plan (AAP) is a~     written plan produced by a physician for a patient with asthma, to provide education and~     guidelines for self-management of worsening asthma symptoms. Studies have shown that AAPs~     effectively improve asthma control, but physicians fail to provide AAPs due to lack of time~     and adequate skills. Physicians also often fail to determine if their patients have good~     asthma control, and to adjust medications in response to patients' control level. The~     investigators propose to develop and test a computerized tool that will help physicians to~     determine if their patients' asthma is well controlled, advise them on medication changes~     required according to the current level of control, and automatically generate an electronic~     version of the AAP, all based on patient responses to a questionnaire. The investigators hope~     that this system will eliminate the barriers that physicians face in determining asthma~     control, adjusting medications, and delivering an AAP, and will increase the frequency with~     which physicians are able to achieve these goals in patients with asthma. The objectives of~     the study are to determine the impact of this system on asthma action plan delivery by~     primary care physicians, the frequency of checking control level, and the frequency and~     appropriateness of asthma medication changes (in accordance with control). We will also~     attempt to determine the impact of the system on hospitalisations, emergency room (ER)~     visits, unscheduled visits to the doctor, total visits to the doctor, days off work or~     school, nocturnal asthma symptoms, daytime asthma symptoms, daytime rescue puffer use, and~     quality of life, and to measure physicians' perceptions of and satisfaction with the system.~   "
190565|NCT01070082|"~     Pain associated with procedures performed on adult ICU patients is ubiquitous and the subject~     of research attention.While there is growing evidence about the prevalence, characteristics~     and measurement of procedural pain in ICUs, most of this evidence has been derived from~     English-speaking patients in the United States who were able to verbally report the intensity~     and distress of this pain. Frequently performed procedures include turning,chest tube~     removal,wound care/wound dressing change,endotracheal suctioning,central catheter~     insertion(arterial/venous, have been a focus for research. Other potentially painful~     procedures, including lumbar puncture and physiotherapy,are numerous and have not been~     systematically studied in adults.~      Patients unable to verbally report their pain have not been able to participate in procedural~     pain studies, which has limited the generalizability of study results to a narrow population~     of ICU patients.~      The Specific Aims of this proposed European-based, international study of ICU patients~     undergoing selected procedures are to:~        -  Describe patient self-reports of pain intensity and distress~        -  Describe the behaviors exhibited by patients during a procedure, comparing the behaviors~          exhibited by those able versus unable to self-report pain intensity and pain distress~        -  Examine predictors of amount of pain intensity, behavioral responses, and analgesic use~          related to procedures such as gender, age, language spoken, country, and type of~          hospital.~      Validated pain intensity, pain distress, and behavioral observation instruments will be~     methodically translated into the predominant languages spoken in our international study~     sites; research and training packets similar to those developed in a large, multisite study~     in the United States will be developed and provided to data collection sites; and data~     collection will occur over a 6-month period of time. Study data will be analyzed and~     disseminated at international meetings and in publications.~   "
190566|NCT01070069|"~     To determine the safety and effectiveness of PEVAR.~   "
190579|NCT01069887|"~     Hema e-chart is an electronic case record that can be changed in real time and is based on~     the chronological organisation of the infective events and the therapies prescribed. It~     allows the collection of all personal, epidemiological, diagnostic and therapeutic data~     pertaining to the patient, processing it and analysing the results.~      Aims and objectives of the project~      The aims of this registry are:~        -  To assess how many suspected fungal-related febrile episodes identify an infective~          fungal agent~        -  To have a clear view of the diagnostic and therapeutic actions in the management of~          onco-haematological patients with suspected fungal-related febrile episodes~        -  To assess the impact of anti-fungal therapy on the timing of chemotherapy and transplant~          planning~        -  Perform drug-epidemiology relationship analyses, observe toxicity and interactions with~          antifungal therapies by means of the creation of a national database of fungal~          infections in patients affected by malignant haemopathies~      Design~        -  A multicentre, prospective registry for monitoring invasive fungal infections in~          onco-haematological patients~        -  Registration criteria: patients with newly diagnosed malignant haematological diseases~          (acute and chronic myeloid and lymphoid leukaemia, multiple myeloma, non-Hodgkin's and~          Hodgkin's lymphoma, aplastic anaemia, myelodysplastic syndromes), or patients who, as a~          result of onco-haematological pathologies, have undergone allogenic or autologous~          haematopoietic cell transplants, and have ongoing febrile episodes . The recording of~          consecutive febrile events is required~        -  Data collection for each individual patient will be performed according to the method~          shown in the enclosed flow chart. In the case of a new episode for an existing patient,~          said new episode will be recorded in the same case record as a new event. All collected~          data will be coded into the database~        -  Information relating to about 500 suspected fungal-related febrile events requiring~          antifungal therapy is expected to be collected from approximately 60 centres over the~          course of 18 months~        -  Data collection for each event may be performed following the provision of written~          informed consent, which will be obtained from each patient participating in this health~          survey~        -  The data collected will be handled and stored in full compliance with the Italian laws~          governing privacy~        -  Hema e-chart is a non-interventional registry~   "
190580|NCT01069874|"~     Purpose: The study null hypothesis is that vitamin D supplementation will not influence time~     to acute respiratory tract infection in sheltered accommodation residents.~   "
190567|NCT01070056|"~     Poorly controlled hypertension (HTN) remains one of the most significant public health~     problems in the United States, in terms of morbidity, mortality, and economic burden. Despite~     compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC)~     on blood pressure (BP) reduction, their effectiveness remains untested in primary care~     practices, especially among minority patients who share a greater burden of HTN-related~     outcomes including chronic kidney disease, stroke and heart failure. This randomized~     controlled trial offers a unique opportunity to address this gap in the literature. Among 200~     hypertensive African-Americans who receive care in community- based primary care practices,~     we will test the effectiveness of a culturally-tailored comprehensive therapeutic lifestyle~     intervention, delivered through group-based counseling and motivational interviewing~     (MINT-TLC) vs. Usual Care (UC). MINT-TLC is designed to help patients make appropriate TLC~     and develop skills to maintain these changes long-term. Patients in the MINT-TLC group will~     attend weekly group classes focused on TLC for 12 weeks (intensive phase); followed by~     individual motivational interviewing (MINT) sessions for 3 months (maintenance phase).~     Trained research personnel will deliver MINT-TLC with appropriate treatment fidelity~     procedures. Patients in the UC condition will receive a single individual counseling session~     on TLC and print versions of the intervention materials. The primary outcome is~     within-patient change in both systolic and diastolic blood pressure from baseline to 6~     months. Secondary outcomes are levels of targeted therapeutic lifestyle behaviors; and~     proportion of patients with adequate blood pressure control at 6 months~   "
190568|NCT01070043|"~     The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg~     amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood~     pressure in Taiwanese patients.~   "
190569|NCT01070030|"~     This study assessed the efficacy and safety of combination therapy of Aliskiren/Amlodipine or~     Aliskiren/Amlodipine/Hydrochlorothiazide in patients with stage II Hypertension.~   "
190570|NCT01070017|"~     Using quantitative and qualitative data, this study will assess the impact of community~     accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and~     community members in Lima, Peru.~   "
190571|NCT01070004|"~     Sleep deprivation induces degradation of night-time driving ability via sleepiness. Because~     of conflicts between physiological needs and social or professional activities, it is~     necessary to develop affordable countermeasure to sleepiness. In real-life driving studies,~     nap and coffee are efficient countermeasures of sleepiness at the wheel. However the effect~     of caffeine is quick but brief and varies between individuals. There is a need for more~     knowledge in order to know what to recommend to drivers. Exposure to 460-nm monochromatic~     light (blue light) decreases subjective sleepiness and improves performances. One objective~     of this project is to investigate whether blue light exposure during driving would be useful~     in a real driving situation when sleepiness becomes acute. Owing to the fact that our~     knowledge of the effects of exercise on driving is very sparse and to the absolutely need to~     standardize the bouts of exercise that will be applied to the subjects. One objective of the~     present study will be to investigate in a simulator study the effects of a bout of moderate~     exercise on participants driving ability when sleepiness becomes acute. Nocturnal~     neurobehavioral performance varies widely between individuals and only certain subjects seem~     significantly affected by sleep loss. It is of interest to find biological markers for sleep~     drive to identify vulnerable drivers to sleep deprivation or to identify responders to~     sleepiness countermeasures (i.e., coffee and blue light). One objective of this study is to~     determine individual differences (genetic, hormonal and cognitive) in the impairment of~     driving skills induced by sleep loss and in the efficiency of countermeasures (blue light and~     coffee).~   "
190572|NCT01069991|"~     The goal of this study is to help adolescents with asthma learn to control their illness and~     live without restrictions. We hypothesize that an intensive school-based asthma education~     program for students in 9th and 10th grade who have persistent asthma, together with asthma~     education for their primary care physicians, will improve the students' health status,~     quality of life, and ability to control their asthma through self-management.~   "
190573|NCT01069965|"~     This is a safety and dose finding efficacy study to evaluate the effects of BGP-15 over the~     dose range of 100 mg/day to 400 mg/day. Doses are applied once or twice a day for 13 weeks as~     add-on therapy to the combination of metformin and sulfonylurea treatment or metformin alone~     in patients with Type 2 Diabetes Mellitus.~   "
190574|NCT01069952|"~     This study will evaluate the safety and efficacy of deep brain stimulation in treating people~     with several and otherwise treatment-resistant depression.~   "
190575|NCT01069939|"~     To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous~     treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily~     Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric~     and/or duodenal ulcers.~   "
190576|NCT01069926|"~     To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus~     patients with varying degrees of renal impairment and to compare the results with those in~     patients with normal renal function.~   "
190577|NCT01069913|"~     The purpose of this study is to measure two different formulations of BG00012 to determine~     how much of each formulation of BG00012 reaches the blood stream and how long it takes the~     body to get rid of it, when given as a single dose.~   "
190578|NCT01069900|"~     The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin~     in a pediatric population 3 months to <18 years old. Approximately 450 pediatric subjects~     with a complicated intra-abdominal infection will be enrolled in the study and treated with~     either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem~     (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.~   "
190581|NCT01069861|"~     Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will~     reduce the need for inhaled nitric oxide.~   "
190647|NCT01068977|"~     This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous~     (IV) infusion in patients with advanced solid malignancies that are refractory to or for~     which there is no standard of care. The study consists of a dose-escalation stage, an~     expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation~     stage testing the combination of MetMAb, at two different doses with bevacizumab at a~     recommended dose.~   "
190582|NCT01069835|"~     The overall aim of the study is:~      To provide accurate and reliable information regarding NSCLC clinical management across~     Central Eastern European countries and Russia in order to detect unmet medical needs of this~     disease in terms of:~        -  Patient and hospital characteristics.~        -  Diagnostic and treatment approaches: initial and subsequent.~        -  Follow-up patterns in clinical management.~        -  Outcomes: symptoms, death, functionality, quality of life.~        -  Use of resources and burden on patients and health care systems. Addendum objective is~          to collect epidemiological data on EGFR mutation status (M+, M-) in the Russian~          population~   "
190583|NCT01069822|"~     The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug~     being developed for the treatment of patients with severe major depressive disorder) has on~     the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your~     body and acts in the body.)~   "
190584|NCT01069809|"~     The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune~     therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the~     individuals are both taking antiretroviral therapy (ART) medication and interrupting ART~     medication.~   "
190585|NCT01069796|"~     Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive~     bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have~     received adjuvant chemotherapy).~   "
190586|NCT01069783|"~     The purpose of this trial is to determine the efficacy and safety of A3309 administered to~     patients with dyslipidemia (high cholesterol levels).~   "
190587|NCT01069770|"~     The purpose of this study is to see whether neoadjuvant administration of Sunitinib reduces~     the size of the primary kidney tumor in patients with metastatic disease undergoing~     cytoreductive surgery. The study will also assess the safety of neoadjuvant Sunitinib,~     objective response rate, respectability of primary tumor, quality of life, and survival~     advantages.~   "
190588|NCT01069757|"~     This is a phase I study to determine the safety, tolerability and recommended phase II dose~     of ARQ 197 given in combination with erlotinib as primary endpoints in patients with~     advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor~     activity of ARQ 197 administered alone or in combination with erlotinib will also be~     determined as secondary endpoints.~   "
190589|NCT01069744|"~     The development of sucking behaviors in preterm infants is thought to reflect neurobehavioral~     maturation and organization. From a clinical perspective, the ability to feed depends upon a~     coordinated sucking, swallowing and breathing pattern. In preterm infants less than 32 weeks~     gestation, this ability is not usually effective enough to sustain full oral feeds. In the~     interim, infants are fed by gavage tube until they are mature enough to take milk directly~     from the breast or bottle (Pinelli, Symington, 2005). Non-nutritive sucking has been used~     during gavage feeding and in the transition from gavage to breast/bottle feeding. The~     rationale for this intervention is that non-nutritive sucking facilitates the development of~     sucking behavior and improves digestion of enteral feeds.~   "
190590|NCT01069731|"~     This is a research study to quantitatively assess the development of non-nutritive suck (NNS)~     and feeding readiness in preterm infants using a novel device, the NTrainer©, and to compare~     this with two clinical assessment tools, NOMAS and EFS.~   "
190591|NCT01069718|"~     This is a research study to determine if an experimental device called the NTrainer can~     improve oral feeding skills more quickly and more effectively than traditional methods in~     infants who are at high risk of feeding dysfunction and delayed hospital discharge.~   "
190592|NCT01069705|"~     This is an open-label, single arm (uncontrolled) study in patients suffering from cystic~     fibrosis, who have completed their study participation in CTBM100C2303 and extension study~     one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at~     enrollment into CTBM100C2303.~   "
190593|NCT01069692|"~     This study will compare placebo to 4 different doses of SBR759 to assess the phosphate~     lowering efficacy in dialysis patients.~   "
190594|NCT01069666|"~     The purpose of this study is to determine knowledge base in diagnosis, investigation and~     treatment of pediatric atopic dermatitis among thai pediatricians.~   "
190595|NCT01069653|"~     The purpose of this study is to evaluate the safety, tolerability, immune response and~     clinical efficacies of HLA-A*2402 restricted epitope peptides CDCA1 and KIF20A emulsified~     with Montanide ISA 51 for advanced small cell lung cancers.~   "
190596|NCT01069640|"~     The purpose of this study is to evaluate the safety, tolerability, immune response and~     clinical efficacies of HLA-A*0201 or HLA-A*0206 restricted epitope peptides URLC10 emulsified~     with Montanide ISA 51 for advanced non-small cell lung cancers.~   "
190597|NCT01069627|"~     This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients~     with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic~     disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week~     cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks~     rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study~     treatment is until disease progression, and the target sample size is <100 individuals.~   "
190598|NCT01069614|"~     A skin stretching device has been designed to stretch tissue prior to surgery, during surgery~     and in order to secure wounds following surgery. The device may be used in non-invasive and~     invasive applications.~   "
190599|NCT01069601|"~     The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in~     immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is~     expected that when administered twice the vaccine fulfills all serological efficacy criteria~     required for the elderly population age 60 years and older.~   "
190600|NCT01069588|"~     To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and~     bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL~     reconstruction.~   "
190601|NCT01069575|"~     The purpose of this study is to evaluate the safety, tolerability, immune response and~     clinical efficacies of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A~     emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.~   "
190602|NCT01069562|"~     With the advancement in microprocessor technology and better understanding of~     pharmacodynamics and pharmacokinetics of anaesthetic agents, computer facilitated closed loop~     control of anaesthesia using propofol has been shown to be accurate with better performance~     than manual control. Literature on computer controlled administration of inhalational~     anaesthetics is few, as it requires the computer to control the dial setting on the~     vapouriser. The investigators intend to compare the computer controlled closed loop~     administration of isoflurane by infusing it into the anaesthetic circuit with conventional~     vaporiser control in elective open heart surgery.~      40 patients (ASA (American Society of Anesthesiology) class II-IV; 18- 65 years) undergoing~     elective cardiac surgery requiring cardiopulmonary bypass (CPB) will be randomly divided into~     manual or closed loop groups. Propofol will be used for induction of anaesthesia in both~     groups followed by isoflurane for maintenance. In the manual group, isoflurane will be~     administered through the Tech 7 vapouriser during pre and post CPB periods to target~     bispectral index (BIS) of 50. In closed loop group, isoflurane will be administered using~     infusion of liquid isoflurane into expiratory limb of the closed circuit. This rate of~     infusion though a conventional syringe pump will be controlled by algorithm termed~     'Improvised Anaesthetic Agent Delivery System' (IAADS) to maintain BIS of 50. Patients in~     both groups will receive 500ml of 100 % oxygen as fresh gas flow. The % of time bispectral~     index (BIS) is within the 10 of set target BIS of 50 will be the primary outcome measure. The~     secondary outcome measures will be median performance error (MDPE)(2), median absolute~     performance error (MDAPE)(2), wobble(2), divergence(2), amount of isoflurane used and~     hemodynamic parameters will be secondary outcome measures.~   "
190603|NCT01069549|"~     India is the Diabetes Capital of the World with 41 million Indians having diabetes, with~     every fifth diabetic in the world being an Indian and type 2 Diabetes Mellitus (T2DM)~     constitutes the major chunk of diabetes. One of the most severe complications of diabetes is~     the development of diabetic nephropathy. Diabetic nephropathy (DN) is the leading cause of~     end-stage renal disease (ESRD) worldwide. There are many identifiable risk factors of~     diabetic nephropathy like hyperglycemia, hyperlipidemia, hypertension, and proteinuria, the~     genetic factor is the main among all. Long-term observational studies show that nearly 30-35%~     of type 2 diabetic patients develop nephropathy, irrespective of glycemic control. The~     regional variation in diabetes prevalence and in the proclivity for diabetes induced renal~     disease; along with reports of familial clustering of nephropathy suggest a possible genetic~     basis. The renin-angiotensin system (RAS) has been strongly implicated in the pathogenesis of~     progressive renal diseases. In addition, the blockage of angiotensin II with either ACE~     inhibitor or an angiotensin type-I receptor antagonist has been found to prevent or delay the~     progression of renal injury associated with diabetes 5 and now these drugs are first-choice~     drugs for the treatment of diabetic subjects with hypertension. The genes encoding the~     renin-angiotensin system (RAS), such as angiotensin-converting enzyme (ACE), angiotensinogen~     (AGT) and angiotensin II receptor type 1 (AGTR1), have been reported to be the most probable~     candidate genes for diabetic nephropathy. As there is no data available for AGTR1~     polymorphism and DN in the north Indian T2DM, its out attempt to fill the scientific gap.~   "
190604|NCT01069536|"~     Study Objective:~      The purpose of this study is to compare the effects of metoclopramide administration in bolus~     versus slow infusion medications in ED patients complaining of nausea for the determination~     of the therapeutic effect and prevention of akathisia.~      Methods:~      This was a prospective, randomized, double-blind trial. The investigation was held between 01~     March 2007 and 01 May 2008, in the Emergency Department of Pamukkale University Faculty of~     Medicine. The patients with moderate to severe nausea randomized and divided into two groups~     as for the previously planned administration type of drug. Ten mg metoclopramide was~     administered in one group with slow infusion (SIG) in 15 minutes, via 2 minutes bolus~     infusion (BIG) into the other group. Whole procedure was observed, akathisia and nausea~     scores and vital changes were recorded.~   "
190605|NCT01069523|"~     All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity~     Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have~     an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the~     baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel~     groups trial. During this trial, dosing will be flexibly adjusted according to patient~     response or presence of side effects. The dosage will range from 1-4 mg. At the end of the~     four week trial, a follow up ERP study will be obtained.~   "
190606|NCT01069510|"~     The purpose of this study is to see if the study drug called spironolactone reduces fibrous~     (stiffening) in heart muscle tissue and improves heart function. Subjects from the study~     titled Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis who have~     evidence of heart dysfunction and/or evidence of fibrosis (stiffening) in the heart muscle~     will be asked to take part in this study.~      This study will include randomizing the subject to receive the study drug or placebo.~     Randomization will occur during visit 1.~      Visit 1 will include the following:~        -  Subjects will answer questions about how well they can breathe.~        -  An MRI. Dye called gadolinium will be injected into the subject's vein.~        -  They will go to the Oregon Clinical and Translational Research Institute where 2~          tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).~        -  They will do a 6 minute walk test..~        -  They will also have an echocardiogram, which is a test that looks at the movement of the~          subject's heart. A technician will place a cool jelly on their chest and use a small~          wand to take pictures through the skin.~      Subjects' will also have visits 3-6 weeks, 3, 6, 9 months, and 12 months after randomization.~     Visits 2-5 will include the following:~        -  They will go to the Oregon Clinical and Translational Research Institute where 1/2~          tablespoon of blood will be drawn.~        -  They will do a 6 minute walk test. During this test, they will walk back and forth in a~          hallway. The goal is to walk as far as possible for 6 minutes. Subjects will probably~          get out of breath or become exhausted. If they do, they can slow down, stop, or rest as~          they need to. Blood pressure will be taken before the walk.~        -  They will have a health review at 6 months.~      Visit 6 will be identical to visit 1 and include the following:~        -  Subjects will answer questions about how well they can breathe.~        -  An MRI. Dye called gadolinium will be injected into the subject's vein.~        -  They will go to the Oregon Clinical and Translational Research Institute where 2~          tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).~        -  They will do a 6 minute walk test..~        -  They will also have an echocardiogram, which is a test that looks at the movement of the~          subject's heart. A technician will place a cool jelly on their chest and use a small~          wand to take pictures through the skin.~      The investigators will compare the study drug, called spironolactone, to placebo with regard~     to any changes in heart stiffening and function of the heart.~   "
190607|NCT01069497|"~     STUDY HYPOTHESIS : An infection prevention program adapted for the nursing home context can~     reduce by 5% the number of infections (urinary, upper and lower respiratory and~     gastrointestinal) in elderly residents in nursing homes.~      STUDY DESIGN : The proposal is for an interventional cluster (nursing home) study comprising~     2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a~     specific infection prevention program; and group 2 (control), 25 nursing homes continuing to~     implement their routine prevention measures.~   "
190608|NCT01069484|"~     Although pregnancy and childbirth are associated with happiness and a positive life change~     for most women, it can also be considered as risk periods for injuries to the pelvic floor~     and development of pelvic floor dysfunction. This may leed to devastating loss of function~     and quality of life (Ashton-Miller & DeLancey 2007).~      The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training~     for primiparous women with and without pelvic floor muscle injury.~   "
190609|NCT01069471|"~     Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate~     vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity~     of the Shigella dysenteriae bioconjugate vaccine (GVXN SD133) alone or in combination with an~     adjuvant (Aluminium Hydroxide). The safety and reactogenicity of the GVXN SD133 vaccine will~     be also evaluated at two different concentrations of antigen, Shigella polysaccharide O1.~     Blood samples will be collected at intervals to examine systemic vaccine antigen-specific~     immune responses.~   "
190611|NCT01069445|"~     Ageing of the population is a major event in the world. Gerontological/geriatric literature~     unanimously indicate that physical exercise and diet are at present the two available~     fundamental approaches to contrast/prevent most of the age associated alterations. In the~     elderly the inflammageing, the oxidative stress and the alteration of the intestinal~     microbiota can be influenced by nutritional status and possibly corrected by an appropriate~     dietetic intervention:~      Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve~     the quality of individual diet for specific needs This study will focus on the development of~     a specific dietary approach through an E-Health dietary service, associated or not to~     nutraceutical food supplements intake, to modulate the oxidative stress, inflammageing and~     gut microflora in the elderly people.~   "
190612|NCT01069432|"~     The purpose of this study is to collect a blood sample from patients with Chronic Lymphocytic~     Leukemia (CLL) and from volunteers without CLL.~   "
190613|NCT01069419|"~     This is an observational, non-interventional, non-comparative, post-authorization safety~     study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need~     of treatment with a biological product.~   "
190614|NCT01069406|"~     The purpose of the present study is to evaluate the occurrence of first trimester bleeding~     among patients with abnormal uterine artery Doppler.~      A prospective study is designed and two groups will be studied; patients with abnormal~     uterine artery Doppler at second trimester (study group) and patient with normal uterine~     artery Doppler at second trimester (control group).The patients will be asked, as part of the~     routine history taken before the US about having first trimester bleeding during the current~     pregnancy.~   "
190615|NCT01069393|"~     The best format for the delivery of structured education for adults with Type 1 diabetes is~     unclear. Currently some hospitals invite their patients to attend a 5 day outpatient course~     run over one week (Dose Adjustment For Normal Eating (DAFNE)). Other centres offer 1 day a~     week for 3 to 5 weeks. We aim to find out whether or not the benefit of benefits are the same~     then it would mean that the course could routinely be offered to patients in either format,~     thus allowing more patient choice and flexibility.~   "
190616|NCT01069380|"~     Research objective: to measure resting metabolic rate (REE) in long term, bed ridden,~     chronically ill patients and to compare their measured energy needs to standard REE equations~   "
190617|NCT01069367|"~     This is to evaluate immunogenicity based on EMEA/CHMP criteria, and safety & tolerability of~     cell-derived A/H1N1 influenza HA vaccine in healthy Japanese elderly subjects.~   "
190618|NCT01069354|"~     To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with~     lidocaine~   "
190619|NCT01069341|"~     The purpose of this study was to determine the safety of ranibizumab: a) as a surgical~     adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR)~     induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).~   "
190620|NCT01069328|"~     To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.~   "
190621|NCT01069315|"~     The purpose of this trial is to investigate whether irrigation solution (soap vs. saline~     solution), or irrigation pressure (high vs. low) will decrease the rate of infection among~     patients with open fracture wounds.~   "
190622|NCT01069302|"~     The purpose of this study is to evaluate the effect of high dose clopidogrel as the~     antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for~     percutaneous coronary intervention due to ischemic heart disease.~   "
190623|NCT01069289|"~     The primary purpose of the study is to investigate if Symbicort is more effective than Oxis~     in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in~     patients with COPD.~   "
190624|NCT01069276|"~     The aim of the study is to investigate patients with acute stroke prehospital with~     transcranial duplex ultrasound to detect an infarct of the middle cerebral artery.~   "
190625|NCT01069263|"~     The purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (HBOT) to~     intravesical Dimethyl Sulfoxide (DMSO) instillation for the treatment of patients who suffers~     from Interstitial Cystitis / Painful bladder syndrome.~   "
190626|NCT01069250|"~     The aim of the study assesses static and dynamic cerebrovascular autoregulation daily over~     one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the~     temporal profile of the autoregulatory status.~   "
190627|NCT01069237|"~     The purpose of this study is to assess the lens and lens case microbial colonization~     associated with marketed care solutions used by experienced soft lens wearers.~   "
190628|NCT01069224|"~     Role of proinflammatory factors in Patients with Rotator Cuff Disease~      Objective:~      To measure the levels of various cytokines and metalloproteases in patients with rotator cuff~     disease, and control group and to determine the correlations among them.~   "
190629|NCT01069211|"~     The purpose of this study is to assess clinical outcomes after Letrozole treatment according~     to the estrogen receptor expression in postmenopausal women with hormone receptor positive~     breast cancer.~   "
190648|NCT01068964|"~     This study will evaluate the safety and efficacy of once daily administered 0.03%~     Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03%~     Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution~     concurrently in patients with open-angle glaucoma or ocular hypertension~   "
190649|NCT01068951|"~     The main hypothesis of the investigators study is that the development of autoimmune diabetes~     may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.~   "
190650|NCT01068938|"~     The purpose of this study is to compare three perimetric techniques regarding progression of~     the visual field.~   "
190651|NCT01068925|"~     The purpose of this study is to determine whether there is a drug interaction between~     GSK1349572 and the HIV protease inhibitors Tipranavir/Ritonavir (TPV/RTV).~   "
190652|NCT01068912|"~     This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating~     the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated~     influenza.~   "
190653|NCT01068899|"~     The purpose of this study is to standardize methods in measuring a person's energy~     expenditure. These methods may be used in a larger study in the future.~   "
190630|NCT01069198|"~     Visceral leishmaniasis (VL) / Kala-azar (KA) is a public health problem in the many countries~     in the world including Bangladesh. Where more than 90,000 VL cases have been reported since~     1994. The disease is fatal if not treated. Even with treatment the mortality rate is high~     (10%). VL is a vector-borne disease, caused by the parasite Leishmania donovani (LD) and is~     transmitted by female sandfly sp. Phlebotomus argentipes. Not all people exposed to the LD~     parasite develop disease. According to our observation only about 30% of the infected with LD~     parasite develop disease within one year of diagnosis. Malnutrition and intestinal helminth~     infection have been found to be associated with the risk of active VL. Down regulation of Th1~     cellular immune response confers susceptibility to active VL. Both malnutrition and~     intestinal helminth infection down regulate the Th1 cellular immune response. Till now there~     is no established prophylaxis against active VL among the people exposed to the LD infection.~     Many studies including ours have been shown that periodic regular deworming reduced~     malnutrition significantly. Micronutrient such as zinc and iron as well vitamin A~     supplementation also improve malnutrition and may enhance Th1 cellular immune response. Thus~     we hypothesize that periodic deworming and. micronutrient and vitamin A supplementation~     together may reduce the risk of active VL among the people exposed to the LD infection.~      The study will be carried out in the Harirampur union, Trishal, Mymensingh. This area is~     highly endemic for VL. Two hundred asymptomatic VL patients aged 2-60 will be enrolled to the~     study. Children aged less than 2 years, pregnant women, active VL case, person with chronic~     disease, disable individuals and those who will refuse written consent will not be enrolled~     to the study. After enrollment subjects will be divided into two groups through~     randomization. One group will receive deworming and nutritional supplement (intervention~     group) and other group will receive placebo (placebo group). Two groups will be followed for~     12 months through active surveillance for developing of active VL. In addition morbidity~     data, monthly stool sampling, monthly anthropometry, urine and blood sampling at baseline,~     before and after treatment of active VL will be carried out Successful completion of the~     study and derived results from it will provide useful information that whether periodic~     deworming with micronutrient and vitamin A supplementation can reduce the risk of active VL~     among the people exposed to the LD infection.~   "
190631|NCT01069185|"~     Morbidity frequency associated to a endotracheal suctioning is different between a necessity~     endotracheal suctioning protocol versus a routine endotracheal protocol.~   "
190632|NCT01069172|"~     The purpose of this study is to evaluate the safety and efficacy of the OptiMedica~     Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with~     cataracts. The safety and efficacy will be compared to the standard surgical procedure of~     continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.~   "
190633|NCT01069159|"~     This study will compare the responses of subjects with traumatic memories of varying vintages~     to either propranolol or placebo in a double-blind setting. It is hypothesized that those~     subjects who receive propranolol will experience less emotional distress when the memory is~     subsequently reactivated and less spontaneous re-experiences.~   "
190634|NCT01069146|"~     Objectives: to evaluate the feasibility, the safety and the effects on physiological~     parameters of mild therapeutic hypothermia during septic shock.~      Design: a randomized, controlled, pilot physiological study. Setting: a 15-beds~     university-affiliated intensive care unit of a teaching Hospital.~      Patients: twenty ventilated and sedated adults patients with septic shock Intervention: Mild~     therapeutic hypothermia between 32 and 34°C during 36 consecutive hours using an external~     water cooling blanket.~   "
190635|NCT01069133|"~     Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome~     and metabolome.~   "
190636|NCT01069120|"~     Safety and efficacy study of 25 and 50 mg doses of Proellex~   "
190637|NCT01069107|"~     The main objective of the project is to assess whether a community hospital may have or~     should have a role in the Norwegian health care system in the acute treatment of a defined~     group of patients.~   "
190638|NCT01069094|"~     A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of~     leiomyomata.~   "
190639|NCT01069081|"~     The objectives of this study are to evaluate the efficacy and tolerability of high dose~     proton pump inhibitor combined with chemotherapy in metastatic breast cancer.~   "
190640|NCT01069068|"~     Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design,~     affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea.~   "
190641|NCT01069055|"~     The purpose of this study is to determine whether lornoxicam or paracetamol is more effective~     in providing pre-emptive analgesia for adult patients undergoing elective unilateral inguinal~     hernia repair under general anesthesia.~   "
190642|NCT01069042|"~     Hypothesis: Rho, one of the small GTPase proteins, and its downstream target molecule,~     Rho-kinase (ROCK), play important roles in mediating various cellular functions, including~     contractility, actin cytoskeleton organization, cell adhesion and motility, proliferation,~     cytokinesis and gene expressions, all of which are involved in the pathogenesis of~     cardiomyocyte contractility and other vascular disease. The investigators thus hypothesize~     that ROCK pathway plays an important role in the function and severity of heart failure (HF)~     and can be one of the possible pathway that currently applied cardiovascular medicine~     affecting their prognosis among HF treatment.~      Previous study has shown that in patients with HF, intra-arterial infusion of fasudil causes~     preferential increase in forearm blood flow as compared with control subjects, suggesting an~     involvement of Rho/Rho-kinase pathway in the increased peripheral vascular HF failure remain~     to be examined. Besides, whether the rho kinase activity was enhanced or their response to~     current medication in HF patients remained unsolved.~      Aim: ROCK activity and left ventricular function between HF or non-HF population survey and~     their response to ACEi Tx.~   "
190643|NCT01069029|"~     The purpose of this study is to compare functional and anatomical results of a combined~     surgery and two time surgery for macular hole and cataract extraction in one hundred and~     twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic~     centers.~   "
190644|NCT01069016|"~     Sacral nerve modulation (SNM) is an established treatment for refractory lower urinary tract~     and bowel dysfunction (Spinelli 2008). Pudendal nerve stimulation (PNS) has been proposed for~     patients failing SNM treatment of urinary dysfunction (Spinelli 2005). In this study SNM and~     PNS are compared for the treatment of fecal incontinence. In a test phase, both treatments~     will be applied for one week each in a randomized and blinded order (cross-over design).~     After the test phase the more successful treatment will be determined and applied~     permanently. If both treatments are equally sufficient, PNS will be chosen for permanent~     stimulation, since preliminary data indicate that PNS has a lower power consumption than SNM.~     Lower power consumption results in a longer lifetime of the stimulator, thus requiring less~     replacement surgeries.~   "
190645|NCT01069003|"~     EDUCATE is a prospective, multi-center study designed to collect real-world safety and~     clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and~     either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet~     therapy (DAPT) drug regimen.~   "
190654|NCT01068886|"~     Pancreatoduodenectomy (PD) is performed in many high volume centers with a very low~     mortality. Reduced mortality rate is largely the result of careful patient selection,~     improved intraoperative management and a better postoperative care. Unfortunately, there is~     not a similar reduction in morbidity rates which remains about 40%. Persistent morbidity is~     predominantly due to pancreatic fistula (PF). Abdominal abscess and hemorrhage are common~     sequelae of PF which have been associated with a high mortality rate. While many different~     risk factors have been reported, a soft pancreatic texture and a nondilated pancreatic duct~     have been most consistently linked to high rates of PF. A number of methods for reducing the~     incidence of PF have been proposed and analysed. Many of these involve technical features of~     the anastomosis, including site of reconstruction, anastomotic technique, use of biologic~     glue, and prophylactic use of somatostatin analogue. The placement of a stent through the~     pancreatic anastomosis is an attractive strategy to reduce the PF rate. This multicenter~     prospective randomized trial was designed to compare the outcome after PD with external~     drainage stent versus no stent in patients with high risk of PF (with soft pancreas and a~     diameter of wirsung <3mm).~      Analysis:The primary objective of the study was to compare the incidence PF in patients with~     or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature~     experience, it was calculated that a reduction to 10% of PF rate would require the inclusion~     of 75 patients in each group (statistical significance P < 0.05 and power 80 per cent with a~     two-tailed test of proportions). We'll enroll 158 patients to take into account the~     possibility of 5% being lost to follow-up.~   "
190655|NCT01068873|"~     The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir~     (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an~     HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty~     patients will be enrolled and studied for 48 weeks.~   "
190656|NCT01068860|"~     This was a 10-week, placebo-controlled, randomized study to investigate the effect of~     injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or~     Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.~   "
190657|NCT01068847|"~     This study involves giving psychoactive drugs intramuscularly (injected into the muscle of~     the upper arm or the hip) and/or orally, and measuring the participant's ability to tell the~     difference between one drug and another, as well as measuring the effects of the drugs on~     mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each~     participant will receive 2-4 of the listed interventions.~   "
190658|NCT01068834|"~     Many patients prescribed statins to lower their cholesterol stop taking their statin over~     time. The purpose of this study is to determine whether providing subjects their KIF6 carrier~     status (associated with increased cardiovascular event risk) will improve adherence to statin~     medications.~   "
190659|NCT01068821|"~     The purpose of this study is to compare two cushioning materials (a gel mattress and an~     egg-crate foam mattress) placed beneath patients undergoing gynecologic surgery to prevent~     patients from sliding toward the head of the bed during head-down positioning.~      Our hypothesis is that the two materials will be equally good at preventing slide on the~     table and that slide will be less than 5 cm (<2 inches) on average.~   "
190660|NCT01068808|"~     The purpose of this study is to evaluate development of allergic rhinitis in children with~     nonallergic rhinitis.~   "
190661|NCT01068795|"~     The risk of venous thromboembolism increases in pregnancy. Thrombophilia whether genetic or~     acquired, is a hypercoagulable disorder that may increase the risk of venous thromboembolic~     events. Clinically, these events are presented as maternal deep vein thrombosis and pulmonary~     emboli. Thrombophilias are also associated with adverse fetal outcomes including intrauterine~     growth restriction, intrauterine fetal death, severe preeclampsia, placental abruption and~     recurrent abortions.~      Pregnant women who experienced one or more of the above complications are advised to be~     examined for the presence of the genetic or the acquired form of thrombophilia.~      Low molecular weight heparin prophylaxis, an anticoagulant, is advised for pregnant women~     with a history of thromboembolism, and many experts recommend prophylaxis for pregnant~     patients with a known thrombophilia and history of adverse pregnancy outcomes associated with~     these hypercoagulable states.~      Physiologic changes in normal pregnancy, including weight gain, increased renal clearance and~     volume of distribution, may decrease the availability of low molecular weight heparin~     (Enoxaparin or Dalteparin), or produce a less predictable response in pregnant women compared~     with nonpregnant women. There are no clear recommendations for use of prophylactic low~     molecular weight heparin in pregnancy. Clinicians tend to use doses suggested for nonpregnant~     patients. Regarding pregnant patients taking enoxaparin or dalteparin, the American College~     of Obstetricians and Gynecologists states that because of the lack of data regarding~     adequate dosing during pregnancy, anti-factor Xa levels may be monitored.~      Two recently published studies demonstrated that plasma anti-factor Xa levels during~     pregnancy were lower than expected, indicating that many pregnant patients may receive a~     subprophylactic dosing.~      Our objective is to check pregnancy outcome among thrombophilic women treated with an~     adjusted enoxaparin thromboprophylaxis dosage according to anti-factor Xa plasma levels~     compared to women with fixed dosage.~   "
190662|NCT01068782|"~     This is a study of multiple regimens of single-agent XL184 in subjects with grade IV~     astrocytic tumor in first or second relapse. The Randomized Phase of the study will evaluate~     the safety, tolerability, and preliminary efficacy of four XL184 dosing regimens in separate~     study arms. Subjects will be randomized to one of the study arms, which will not be blinded.~     After the Randomized Phase, additional subjects will be enrolled to further expand one study~     arm in the Expansion Phase.~   "
190663|NCT01068769|"~     The purpose of this research study is to determine the safety and activity of regorafenib in~     participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved~     therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug~     that blocks abnormally active signaling enzymes called tyrosine kinases which are important~     to the growth of GIST. This tyrosine kinase inhibition is similar to the way that both~     imatinib and sunitinib work; however, regorafenib blocks certain additional signaling~     pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested~     in GIST participants before this research study.~   "
190664|NCT01068756|"~     The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of~     dapagliflozin~   "
190665|NCT01068743|"~     To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination~     (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage~     Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed~     condition.~   "
190666|NCT01068730|"~     To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by~     BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in~     Australia by Alphapharm in the fed state~   "
190667|NCT01068717|"~     To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose~     combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin~     (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy~     participants in the fasted and fed states.~   "
190668|NCT01068704|"~     The purpose of this study is to determine if BMS-690514 + letrozole will be more effective~     than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast~     cancer after developing progressive disease immediately following adjuvant antiendocrine~     therapy~   "
190669|NCT01068691|"~     A dissecting or intramural haematoma of the thoracic aorta (AH) is a haemorrhage that~     dissects the aortic wall. An entry point is detected at an intimal tear, ulcer or plaque~     rupture via imaging in almost 50% of cases. AH occurs in older patients than those with AD~     and develops on atheromatous lesions with parietal ulcers, most often in cases of poorly~     managed, pre-existing hypertension (HTN). Type A AHs, which affect the ascending aorta,~     frequently progress towards an AD with a high risk of mortality, and represent a surgical~     indication.~      Patients who have presented AD or AH, whether they have been operated or not, must undergo~     prolonged monitoring. This involves both clinical and radiological checks to ensure that~     blood pressure is properly monitored, that the parietal lesions have receded and that there~     are no complications.~      HTN is a recognized risk factor for the onset of AD and systolic blood pressure must be~     brought down to between 100 and 120 mmHg perioperatively. Furthermore, HTN is also a risk~     factor for the rupture of unoperated type B AD. Despite this, only two studies have looked at~     BP management in AD patients. The first, carried out among chronic type A or B AD patients~     revealed that closer monitoring of blood pressure levels at home led to a better long-term~     prognosis. Another study revealed a 60% prevalence of non-managed clinical HTN among 40~     chronic AD patients.~      Whilst frequent, regular aortic wall monitoring via imaging methods (CT or MRI) is~     recommended after thoracic AD surgery, there is no precise recommendation as to the method of~     BP monitoring in very high-risk patients. A BP level of 135/80 mmHg has been suggested as a~     maximum limit for patients having been operated for AD. In order to achieve this,~     antihypertensives of several therapeutic classes must be used, with beta-blockers as a~     priority. The same can be said for AH, as it has been demonstrated that the absence of~     beta-blocker treatment is a predictive factor for poor progress.~      Increased aortic stiffness can cause increased systolic blood pressure and is recognized as~     an independent cardiovascular risk factor. This stiffness can be detected by measuring the~     carotid-to-femoral pulse wave velocity (PWV). No study has as yet focused on assessing aortic~     stiffness in patients who have undergone AD or AH surgery.~      Obstructive sleep apnea syndrome (OSAS) in thoracic AD patients is highly prevalent, and~     respiratory events that occur are more severe. This has prompted some to suggest that~     systematic detection of OSAS after AD should be carried out. No findings have yet been~     published about patients who have undergone AH surgery.~   "
190670|NCT01068678|"~     This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical~     trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin~     glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or~     with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified~     treatment.~   "
190671|NCT01068665|"~     This trial is conducted in South Africa, Europe and North America. The aim of this trial is~     to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine~     (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4~     (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic~     drugs (OADs) qualifying for intensified treatment.~   "
190672|NCT01068652|"~     This trial is conducted in Africa. The aim of this clinical trial is to investigate the~     effect of 50 weeks of treatment with different intensified insulin administrations (all in~     combination with a fixed dose of metformin) on blood sugar control in subjects with type 2~     diabetes inadequately controlled by oral anti-diabetic drugs (OADs).~   "
190673|NCT01068639|"~     This study is conducted in Europe. This observational study aims at evaluating compliance~     with growth hormone treatment in children and identifying factors influencing compliance.~   "
190674|NCT01068626|"~     The purpose of this study is to investigate whether 6 months treatment with the~     cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged~     men.~   "
190675|NCT01068613|"~     This study will assess the bronchodilator effects of multiple doses of QAX028 at two~     different dose levels when compared to tiotropium and placebo in a COPD population.~   "
190676|NCT01068600|"~     This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.~   "
190677|NCT01068587|"~     RATIONALE: MET/VEGFR2 inhibitor Foretinib and erlotinib hydrochloride may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow~     to the tumor.~      PURPOSE: This randomized phase I/II trial is studying the side effects of erlotinib~     hydrochloride when given together with or without MET/VEGFR2 inhibitor Foretinib and to see~     how well it works in treating patients with locally advanced or metastatic non-small cell~     lung cancer that has not responded to previous chemotherapy.~   "
190678|NCT01068574|"~     The purpose of this study is to assess whether the BASIC Scale--a simple, non-invasive~     clinical triage protocol--predicts severe illness, hospitalization or death among children~     under age five presenting for acute care in a rural African health center.~   "
190679|NCT01068561|"~     The purpose of this study is to evaluate the short-term safety of a single intravitreal~     injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.~   "
190680|NCT01068548|"~     This is a pilot study to implement a computer based intervention to safely reduce length of~     hospital stay and time to conversion to oral antibiotics for patients with pneumonia.~   "
190681|NCT01068535|"~     The purpose of this study is to compare the vascular permeability of blood vessel walls (of~     the carotid artery) in pre-menopausal women who have metabolic syndrome (syndrome of having~     at least 3/5 following features- increased abdominal fat, low good cholesterol (HDL-C),~     elevated fasting blood fats (triglycerides), elevated blood pressure, an elevated fasting~     glucose) versus those women who are normal weight and with normal cholesterol, blood fats,~     blood pressure, and blood sugar. We are using a novel technology to measure vascular~     permeability known as dynamic contrast enhancement magnetic resonance imaging (DCE-MRI). The~     primary variable is ktrans ratio which is a mathematically derived quantity obtained from~     DCE-MRI. We are trying to identify novel markers of early atherosclerosis in young women.~   "
190719|NCT01068041|"~     The primary objective of this clinical study is to evaluate the effectiveness and safety of~     PH3 for patients with diabetic nephropathy.~      The secondary objectives are to identify the optimal dosage for subsequent studies and to~     provide basis for the next confirmatory study in study design, endpoints, and study~     methodologies.~   "
190720|NCT01068028|"~     The purpose of this study is to evaluate the safety and tolerability of multiple ascending~     doses of ORM-12741.~   "
190721|NCT01068015|"~     The purpose of this study is to evaluate the effectiveness of the community based~     comprehensive HIV/STIs intervention among MSMs in China.~   "
190682|NCT01068522|"~     People who survive severe traumatic brain injury (TBI) live with profound cognitive~     impairments that alter their developmental course and define their future possibilities.~     Worldwide, TBI is the leading cause of death and disability among children and adolescents~     (Murgio, 2000). In the United States, the annual incidence of TBI is six times greater than~     that of multiple sclerosis, HIV/AIDS, spinal cord injury, and breast cancer combined [Centers~     for Disease Control, American Cancer Society, National Multiple Sclerosis Society]. The~     burden of TBI may be even greater in developing countries, due to civil unrest and war, and~     to the absence of mandated prevention such as seat belt laws.~      The long-term objective of the investigators' research group is to improve outcomes for~     survivors of TBI in Latin America. To that end, the investigators have created a structure~     for professionals and institutions involved in the treatment of TBI to generate research; to~     facilitate education, standardization, certification, the dissemination of information and~     resources; and to foster the development of evidence-based guidelines. The structure is the~     Latin American Brain Injury Consortium (LABIC).~   "
190683|NCT01068509|"~     The purpose of this study is to determine the safety and efficacy of an investigational~     therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to~     determine its ability to prevent cancer from returning.~      Study objectives~      Primary objectives:~        -  To confirm the safety of administering Cvac in this population.~        -  To determine the effects of Cvac on progression-free survival (PFS).~      Secondary objectives:~        -  To determine overall survival (OS) for ovarian cancer patients who receive Cvac after~          achieving remission in the first or second-line setting.~        -  Evaluation of host immunologic response to Cvac administration.~   "
190684|NCT01068496|"~     This study looks at global gene expression in pterygium and found the derangement of matrix~     genes in particular to be a feature of pterygium. In the investigators opinion, it would be~     more beneficial to elicit changes in gene expression before the recurrence of pterygium and~     by developing a panel of biomarkers that are associated with pterygium recurrence; one would~     be able to predict the post surgical prognosis of patients after resection.Biomarker levels~     will be compared to discover a biomarker panel for prediction of recurrence.~   "
190685|NCT01068483|"~     This is a first-in-man, phase I clinical research study with BKM120, a potent and highly~     specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists~     of a dose escalation part followed by a MTD expansion part.~      Once the MTD has been defined, the MTD expansion part will be opened for enrollment.~   "
190686|NCT01068470|"~     Therapy with Interleukin-2 stimulates lymphocytes in humans to become Lymphokine-activated~     Killer cells (LAK). This study will determine if these killer cells are able to kill certain~     standard cell-lines in the laboratory.~   "
190687|NCT01068457|"~     This is an explorative study investigating potential nerve injury after VATS.~   "
190688|NCT01068444|"~     Recent studies have demonstrated that PPARγ as well as diet control could improve glycemic~     control, decrease serum ALT level, decrease hepatic fat distribution, and increase~     intrahepatic insulin sensitivity. The purposes of this study are:~      1. Primary aims:~        1. Comparison between Pioglitazone and placebo groups in terms of steatosis and liver~          function tests.~        2. Evaluation of clinical safety of Pioglitazone~      2. Secondary aims:~        1. Comparison between Pioglitazone and placebo groups in terms of liver necroinflammation~          and fibrosis.~        2. The impact of Pioglitazone on the related metabolic index, including insulin~          resistance(HOMA-IR), newly-onset diabetes, metabolic syndrome, lipid profiles (T-Chol,~          HDL-C, LDL-C, TG).~        3. Comparison between Pioglitazone and placebo groups in terms of high-sensitive C-reactive~          protein changes.~      3. Interventional aim: Assessment the association between magnetic resonance imaging study~     and intrahepatic fat distribution before and after Pioglitazone treatment.~   "
190689|NCT01068431|"~     Juxta-Fit is used for compression treatment. Juxta-Fit is an inelastic compression device~     which can be easily adjusted to the circumference of the limb and is usually used during the~     maintenance phase of lymphedema treatment. The aim of the study is to assess the~     effectiveness of Juxta-Fit in the initial treatment phase of leg lymphedema compared to the~     traditional treatment with Trico bandages in relation to interface pressure and to explore if~     self-management by Juxta fit is efficient after a short demonstration. Data are collected at~     0-2-24 hours~   "
190690|NCT01068418|"~     Hypothesis: Vitamin D supplementation lower renin-angiotensin system activity in obesity.~      Specific Aim: To investigate whether Vitamin D supplementation in obesity improves the~     vascular sensitivity to angiotensin II.~   "
190691|NCT01068405|"~     Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.~      At present time,there is no effective treatment against digital arthritis. The investigators~     purpose to measure the efficacy of methotrexate on digital arthritis.~      In this aim, two groups were compared. The first group receive 10mg/week of methotrexate~     administered in one shot (every Monday for example)during 12 months. The second group receive~     10mg/week of placebo according to the same procedure~   "
190692|NCT01068392|"~     The investigators are willing to investigate the efficacy and safety of oxaliplatin and~     prednisolone (Ox-P) combination in patients with previously treated MZL who have a few~     clinical trial data.~   "
190693|NCT01068379|"~     The purpose of this randomized clinical trial was to compare reattachment rates among~     patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with~     retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.~   "
190694|NCT01068366|"~     This study is for patients who have been diagnosed with either a Patent Foramen Ovale [PFO]~     or an Atrial Septal Defect [ASD]. These are a type of hole located in the wall that separates~     the top two (2) chambers of the heart. You have been recommended to receive an atrial septal~     occluder device [a device specifically designed to close PFOs and ASDs] implanted in your~     heart to close this hole. Because these devices are made of materials that contain nickel,~     this trial is being conducted to perform blood nickel tests on those patients already~     referred for an atrial septal occluder device such as yourself. The purpose of this study is~     to compare levels of nickel in the blood in patients receiving either the Amplatzer or the~     Helex devices.~   "
190695|NCT01068353|"~     The primary aim of the study is to determine the safety and tolerability of etanercept in~     subjects with Alzheimer's Disease. The effects of etanercept on cognitive, behavioural,~     functional and immunological outcomes will be examined as secondary aims.~   "
190696|NCT01068340|"~     The formation of intraperitoneal adhesion following abdominal surgery is accepted by~     clinicians as an inevitable consequence. More than 90% of patients undergoing a surgical~     procedure in the abdomen will develop intraperitoneal adesions. The incidence however, of~     small bowel obstruction (SBO) resulting form these adhesions is far lower. To date, it is~     unknown which risk factors predispose these patients to develop SBO. Several have been~     proposed, such as age, peritonitis, or surgery for small bowel injury resulting from~     gunshots. None of them however, has been widely accepted.~      During the last 20 years the significant lifetime risks associated with this phenomenon and~     its impact on the quality of life of patients has been well recognized. In addition, the~     burden on healthcare resources due to complications caused by adhesions is increasing and~     medicolegal consequences are rapidly evolving.~      Early SBO following laparotomy for trauma is a poorly described entity. A few retrospective,~     single institution studies with a low number of patients have tried to address this issue.~     However, these studies either included a subset of trauma patients, i.e. patients sustaining~     penetrating trauma,[4] or patients undergoing a negative or non-therapeutic laparotomy, or~     examined only the incidence of SBO requiring surgical intervention. In addition, recent data~     regarding this issue is lacking, especially after the implementation of the damage control~     concept and the other advances in trauma surgery.~      The aim of this study is to define the incidence of early SBO following laparotomy for trauma~     and to examine possible risk factors associated with its development.~   "
190697|NCT01068327|"~     This phase I trial is studying the side effects and best dose of stereotactic radiation~     therapy and nelfinavir mesylate when given together with gemcitabine hydrochloride,~     leucovorin calcium, and fluorouracil in treating patients with locally advanced pancreatic~     cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells~     more sensitive to radiation therapy. Drugs used in chemotherapy, such as gemcitabine~     hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     stereotactic radiation therapy and nelfinavir mesylate together with combination chemotherapy~     may kill more tumor cells.~   "
190698|NCT01068314|"~     The study hypothesis is that 6 weeks of repetitive handgrip exercise will improve endothelial~     function and venous compliance in pre-dialysis patients with an estimated glomerular~     filtration rate of less than or equal to 20 ml/min. If proven correct then arm exercise might~     be useful to improve the success rate for a surgically created arteriovenous fistula in the~     forearm to become usable as a vascular access for hemodialysis.~   "
190699|NCT01068301|"~     Patients with refractory hematologic malignancies, including those who develop recurrent~     disease after allogeneic hematopoietic stem cell transplantation (HSCT) have a dismal~     prognosis. Historically, both regimen-related mortality and disease recurrence have been~     significant causes of treatment failure in this heavily pre-treated patient population. Novel~     therapeutic agents that target molecular signaling mechanisms and increase the sensitivity of~     leukemic cells to apoptosis may clearly play a role in this setting.~      This study hypothesizes that interrupting the SDF-1/CXCR4 axis using the selective CXCR4~     antagonist plerixafor may be useful as a leukemic stem cell mobilizing agent for patients who~     are refractory to standard dose chemotherapy and in relapse after an allogeneic transplant.~     This hypothesis is based on the dependence of leukemia cells on MSCs for survival signals as~     described above and on the preclinical data that suggest increased efficacy by antileukemia~     agents when leukemia cells are separated from MSCs.~      In the present trial, the study proposes to add plerixafor to enhance the conditioning~     regimen cytotoxicity. At this time the goal is to determine the maximum tolerated dose (MTD)~     of plerixafor through the process of dose limiting toxicity (DLT) evaluation. Pharmacokinetic~     studies will be conducted. Additional studies will quantify and the content of leukemia cells~     and key regulatory and effector T cell populations in the bone marrow and blood before and~     after exposure to this medication.~      If the observed outcomes of this trial are promising, it could serve as a platform on which~     to study further use of plerixafor as a complimentary agent with conditioning as well as~     other chemotherapeutic regimens for patients with relapsed or refractory hematologic~     malignancies.~   "
190700|NCT01068288|"~     There is no consensus among pediatric surgeons regarding the optimal treatment for children~     with complicated appendicitis with delayed diagnosis. With the development of broad-spectrum~     antibiotics, some surgeons have advocated expectant management for these children. However,~     there is little evidence to determine which children are most likely to benefit from this~     approach. Prior attempts to determine the effectiveness of expectant management for~     perforated appendicitis with delayed diagnosis often have not controlled for inherent~     differences in the clinical status of patients treated non-operatively vs. those treated with~     immediate appendectomy.~   "
190701|NCT01068275|"~     Randomized trial comparing lumbar plexus catheter versus femoral nerve catheter (single-shot~     femoral block as control group) for postoperative pain control after anterior cruciate~     ligament repair in children (age 11-21). Primary outcome is pain scores for the first 72~     hours. Secondary outcomes include opioid consumption, incidence of opioid side effects and~     quality of recovery (previously validated scale). Our hypothesis is that lumbar plexus~     catheter will provide superior pain control and overall quality of recovery compared to~     femoral nerve catheters.~   "
190702|NCT01068262|"~     This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked~     telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib~   "
190703|NCT01068249|"~     The goal of this clinical research study is to learn if the combination of RAD001~     (everolimus) and Femara (letrozole) can help to control recurrent or progressive endometrial~     cancer. The safety of this drug combination will also be studied.~   "
190722|NCT01068002|"~     Cardiovascular & echocardiographic assessment in pregnant women with hypertension during~     their pregnancy in comparison to Pregnant normotensive women.~   "
190723|NCT01067989|"~     Low-dose metronomic(LDM)chemotherapy as well as anti-inflammatory agents and bisphosphonates~     have shown anti-angiogenic properties on tumor vasculature.~      This study is meant to test the therapeutic potential of an anti-angiogenic treatment~     strategy by combining all these agents for metastatic breast cancer patients.~   "
190704|NCT01068236|"~     This project will examine the effectiveness of a primary care based intervention to help~     overweight teen girls adopt healthy lifestyle practices. Participants are adolescent females~     at select Kaiser Permanente Northwest primary care clinics with a body mass index above the~     90th percentile. Teens will be randomly assigned to (1) a behavioral weight control program~     (enriched intervention), (or 2) usual-care (control). Primary care providers of teens in the~     intervention condition are given customized plans describing the teen's eating and physical~     activity habits and instructions on how to best work with these teens and their families. The~     behavioral weight control program is specifically tailored for teen girls and includes~     separate group meetings for teens and parents, follow-up telephone contacts with their group~     leader, and coordinated feedback from the teen's primary care provider.~   "
190705|NCT01068223|"~     The purpose of this study is to investigate the effect of JNJ-39758979 compared to placebo on~     histamine induced itch in healthy male volunteers.~   "
190706|NCT01068210|"~     The purpose of the study is look at the effects of different types of exercise training with~     a stretching group and its effect on lung cancer patients. Subjects will take part in a 16~     week training intervention that can consist of aerobic, resistance, aerobic & resistance, or~     a control group. Pre and Post testing will include stress tests, echos, blood, and urine~     samples.~   "
190707|NCT01068197|"~     The purpose of this study are to:~        1. compare two diet plans - a low-glycemic load (low-GL) diet and a low-fat diet. A low-GL~          diet is expected to keep blood sugar levels more normal, and because the sugar levels~          stay normal, prevent rapid rises of insulin in the blood. We want to test if Hispanic~          children at-risk for type 2 diabetes who are given a low-GL diet will have less insulin~          resistance, will lose more weight, and will decrease their chance of getting type 2~          diabetes.~        2. compare the effects of Low-GL and high-GL meals on appetitive, hormonal, and metabolic~          responses of obese Hispanic youth under controlled, standardized conditions. We want to~          test if children fed low-GL meals would have lower glucose and lower insulin responses,~          report less hunger and consume less energy than those fed high-GL meals.~   "
190708|NCT01068184|"~     AZD6553 is a new drug being developed as a possible treatment for patients with chronic~     obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair~     of two commonly co-existing diseases of the lungs in which the airways become inflamed and~     the small airsacs of the lungs become damaged. This leads to a limitation of the flow of air~     to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of~     airflow is poorly reversible and usually gets progressively worse over time. There is an~     urgent medical need for therapies that could slow disease progression by targeting the~     underlying mechanisms associated with the changes in the lungs in patients with COPD. AZD6553~     acts by reducing the activity of a protease found to be involved in the disease process in~     COPD. AZD6553 is being developed as a novel oral treatment to control the symptoms and~     exacerbations of COPD, and reduce the progression and severity of the disease. The purpose of~     this research study is to determine how safe and well-tolerated AZD6553 is and how much~     AZD6553 enters blood circulation by collecting blood and urine samples during the study. We~     are also investigating what AZD6553 is broken down into, when given orally, how much of the~     drug is cleared from the body via the kidneys, and the effect of taking the drug after food.~     This will all be done by analysis of blood and urine samples taken at various point during~     the study.~   "
190709|NCT01068171|"~     The purpose of this study is to determine which treatment, over 6 months, will promote~     healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective~     way.~   "
190710|NCT01068158|"~     The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective~     treatment for head lice infestations.~   "
190711|NCT01068145|"~     Trial to evaluate the dose response of SCH 527123 in reducing inflammation from an~     ozone-induced sputum neutrophilia in both healthy subjects and subjects with COPD.~   "
190712|NCT01068132|"~     Italian, multicentre, non comparative trial in patients with advanced Colorectal~     Cancer(CRC)and KRAS wild-type, defined by molecular evaluation.~      Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity~     developed or patient refusal.~      The aim of this study is to assess the prognostic role of PTEN in terms of Progression free~     survival.~      Although the role of Cetuximab as first line treatment in metastatic CRC will be soon~     established, it is still unclear which is the best schedule for Cetuximab and the role of~     biological factors in order to select the most appropriate subset of pts for recommending~     Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the~     perspective to study the role of other molecular markers in this subset of pts.~      On the basis of these considerations this study is aimed at testing a different schedule of~     Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.~   "
190713|NCT01068119|"~     Same day discharge is safe and feasible in selected troponin negative patients undergoing~     coronary planned percutaneous coronary intervention (PCI) or ad hoc PCI via the transfemoral~     approach.~   "
190714|NCT01068106|"~     The aim of this prospective, randomized study is to compare the efficacy and safety of~     biodegradable polymer based limus-eluting stents (BPDES) with permanent polymer based~     everolimus eluting stents (PPDES).~   "
190715|NCT01068093|"~     The purpose of this study is to assess the effects of Ezetimibe on coronary plaque volume in~     patients with acute coronary syndrome.~   "
190716|NCT01068080|"~     The investigators evaluated predictive values of myocardial fatty acid metabolism and insulin~     resistance for cardiac death of hemodialysis patients with normal coronary arteries.~   "
190717|NCT01068067|"~     The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra~     sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.~   "
190718|NCT01068054|"~     The study was a double-blind, parallel study to compare efficacy of 0.1% tacrolimus~     ophthalmic ointment vs 2% cyclosporine eye drops in children with vernal~     keratoconjunctivitis. The duration of the blinded period was 8 weeks followed with 4 weeks of~     open-period of tacrolimus ointment. The hypothesis was that tacrolimus was as effective as~     cyclosporine for the treatment of this condition.~   "
190734|NCT01067833|"~     To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for~     up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained~     symptomatic atrial fibrillation (AF duration >3 days and <6 months).~   "
190724|NCT01067976|"~     The purpose of this study is to look at the efficacy (how does it work) and safety of~     gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of~     breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the~     breasts as MRI may detect additional breast cancers.~   "
190725|NCT01067963|"~     The purpose of this study is to establish the usefulness and the impact of a tailored~     behavioral-education and counseling intervention titled Self-Management and Resourceful~     Transition (S.M.a.R.T) among patients with type 2 diabetes mellitus and stage 3 chronic~     kidney disease, in order to help them to manage their behaviors related to their condition~     and health.~   "
190726|NCT01067950|"~     Current medical therapies are not able to prevent progression of established macroproteinuira~     (i.e. diabetic nephropathy) to end-stage renal failure in type 1 (insulin dependent) diabetic~     patients. In this setting, proteinuria is a major risk factor for mortality. Pancreas~     transplantation, on the contrary, can revert diabetic nephropathy and thereby prevent~     end-stage chronic renal failure, with theoretically lower risk of death as compared to~     current medical therapies.The main objective of this study is to assess superiority of~     isolated pancreas transplantation versus intensive exogenous insulin therapy in type 1~     diabetic patients with overt diabetic nephropathy and mildly reduced renal function. The~     primary endpoint is a composite efficacy/failure end-point including: patient mortality and~     renal function impairment during 5 years in patients with badly controlled diabetes and~     nephropathy resisting to up-to-date nephroprotective therapies.Main secondary objectives are~     safety and efficacy of both regimens, including proteinuria and renal histology evaluation,~     metabolic control and quality of life, acute and chronic extrarenal complications of~     diabetes, pancreas survival and all risks related to the transplant procedure (anaesthesia,~     surgery and immunosuppression side-effects) and to the intensive insulin therapy management.~   "
190727|NCT01067937|"~     Despite the fact that appendicitis is one of the most frequent surgical pathology in~     children, its clinical management is still debated. Previous reports have shown rate of~     appendectomy in children without appendicitis up to 30 %. Morbidity, due to infectious~     complications or intestinal obstruction, is often between 5 and 10 % of published cases, and~     increase medical and social costs. Evidence-based medicine concept could therefore be~     worthwhile in that context, in order to promote rational diagnosis and treatment of that~     frequent medical condition.An algorithm describing management of children with suspicion of~     appendicitis was established, based on recent published data, in order to reduce delay~     between first clinical signs and confirmation of the diagnosis, and to define therapeutic~     indication such as conservative management and interval appendectomy or patient requiring~     laparoscopic approach. The main objective of the study is to decrease morbidity and~     unnecessary appendectomy rates, and secondly to decrease costs, by the use of that algorithm.~   "
190728|NCT01067924|"~     The purpose of the study is to assess the effectiveness of motivational interviewing in~     promoting maintenance of physical activity in people with Type 2 diabetes (T2D) upon the~     completion of a structured exercise program.~      Participants with T2D who are new graduates of a supervised exercise program will be randomly~     assigned to either standard care (SC) or to standard care and in addition, participate in two~     individual motivational interview (MI) sessions (SC + MI).~      The primary outcome will be change in physical activity behavior assessed by the Godin~     Leisure and Exercise questionnaire. Secondary outcomes will include change in blood glucose~     control (A1C), BMI, six minute walk-test, QoL, and self-efficacy.~      Outcomes will be measured in groups at baseline, end of program, 3 months and 6 months~     post-program.~   "
190729|NCT01067911|"~     Scientists believe that what happens to dietary fats after they are eaten, especially how~     they cleared from the blood, affects risks of heart disease and diabetes is more important~     than measuring blood fats after an overnight fast. Little is known about what happens in the~     6-8 hours after eating common oils available in Canada such as soybean, canola, olive,~     sunflower or flax oils. Vegetable oils have different types of fatty acids. This study will~     gather information on what happens to these fatty acids after they are eaten in a meal. The~     purpose of this research is to show that clearance of fat from the blood varies with the type~     of vegetable oil in a meal.~   "
190730|NCT01067898|"~     The purpose of this study is to determine if infrequent administration of oral vitamin D~     megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels~     of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin~     D3 in every three months would be effective and safe treatment to achieve the target levels.~   "
190731|NCT01067885|"~     The MARIS Register is a prospective, multicenter registry of implantation in the superficial~     femoral artery (SFA) with a CE marked stent (Maris / Invatec) intended to capture initial~     angiographic success, complication rate and symptomatic related revascularization by~     following the clinical process and duplex examinations at 6 and 12 month.~   "
190732|NCT01067859|"~     A placebo controlled, double-blind and randomized study to assess different doses of a new~     drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the~     well-being of patients with acute decompensated heart failure.~   "
190733|NCT01067846|"~     For this project, the investigators are interested in exploring a new way to extend and~     maintain drug abstinence in people who are addicted to crack cocaine. This study will combine~     a medication called D-Cycloserine (DCS) and weekly cognitive behavioral therapy (CBT) to~     assess whether the combination will enhance people's ability to stay clean (drug free) for~     longer periods of time.~      One of the greatest risks for drug relapse is drug craving. Oftentimes drug craving occurs~     when a person is confronted with stressors and reminders of past drug use behavior. DCS has~     been shown to enhance the learning of new information. By administering DCS prior to learning~     new techniques such as how to cope with drug craving and drug-use reminders, it is possible~     that patients can be more successful at living a drug free life for a longer period of time.~      In addition to exploring this model behaviorally, the investigators will explore changes that~     may occur in the brain before and after the therapy/medication intervention. A technique~     called MRI (Magnetic Resonance Imaging) will be used to identify areas of the brain that are~     being activated during an attention task. Areas of neural activation will be assessed at~     study entry, end of therapy (4-week endpoint) and one month following completion of the~     treatment program.~   "
190735|NCT01067820|"~     This study is designed to characterize the early effects of ApoA-I synthesis with RVX000222~     on coronary atherosclerotic disease when administered to patients with coronary artery~     disease and have a low HDL-C level, as assessed by Intravascular Ultrasound (IVUS) in~     addition to standard background therapy.~   "
190736|NCT01067807|"~     Healthy female subjects received a single dose of four different types of Proellex, the~     original 25 mg dose and three new formulations~   "
190737|NCT01067794|"~     This observational study was planned, with the primary objective to observe patient survival~     following first-line treatment of patients of Stage IIIB/IV Non-small Cell Lung Cancer~     (NSCLC) with different platinum-based doublets under routine disease management conditions.~     Further secondary objectives of this study are to provide insights to what extent histologic~     subtyping and the use of additional prognostic or predictive biomarkers are currently~     considered for differential therapeutic decisions under routine conditions. All of these data~     are critical to evaluate the factors for differential therapeutic decisions and their effect~     on patient outcomes in a real life setting, and they can only be obtained through~     observational research.~   "
190738|NCT01067781|"~     The purpose of this study is to evaluate and compare the safety and immune responses~     following a two vaccination regimen by transcutaneous immunization with heat-labile~     enterotoxin of E. coli (LT) patches or placebo~   "
190739|NCT01067768|"~     The purpose of this study is to determine whether the daily nurse review of the indication of~     the urinary catheter compared to the everyday care of the working staff is effective to~     reduce the rate of catheter-associated urinary tract infection in adults hospitalized.~   "
190740|NCT01067755|"~     To evaluate the role of the LungPoint VBN System in the bronchoscopic access to a target~     location.~      The evaluation will explore:~        -  Ability of the system to guide a user to one or more target site(s)~        -  Ease of use of the system (assessment of the user interface)~        -  Incremental value brought by the use of the system to the successful completion of a~          case.~   "
190741|NCT01067742|"~     The purpose of this study is to define the natural history of Mucolipidosis Type IV and~     identify potential clinical outcome measures.~   "
190742|NCT01067729|"~     The purpose of this research study is to compare the rate of healing, the infection or~     complication rate, pain perception and scarring from burn injuries using two types of burn~     dressings.~   "
190743|NCT01067716|"~     The results of this trial will demonstrate that AVSS software performs as intended and is~     acceptable in a clinical setting.~   "
190744|NCT01067703|"~     The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on~     perioperative ischaemic injury in patients undergoing cardiac surgery compared to control~     intervention.~   "
190745|NCT01067690|"~     The purpose of this study is to determine the clinical response to daily Indinavir oral~     administration in association with a conventional chemotherapy based on cycles of systemic~     Vinblastine +/- Bleomycin in patients affected by advanced classical (non HIV-associated)~     Kaposi's sarcoma~   "
190746|NCT01067677|"~     To compare ondansetron, metoclopramide, diphenhydramine, and placebo in order to determine~     which anti-emetic is most efficacious as a rescue therapy for pediatric patients ages 3-18~     who have post-operative vomiting after a standardized prophylactic regimen of ondansetron and~     dexamethasone. We hypothesize that anti-emetics with a different mechanism of action than the~     prophylactic regimen will be the most effective rescue therapy in children having surgery~     in an ambulatory surgery center.~        1. Problem: Despite commonly-used anti-emetics for prophylaxis, some children still go on~          to develop post-operative vomiting (POV).~           Goal: To determine which anti-emetic--ondansetron, metoclopramide, diphenhydramine, or~          placebo--is most efficacious for pediatric patients in this situation.~        2. Hypothesis: Anti-emetic medications that have a different mechanism of action than the~          prophylactic regimen will be the most efficacious rescue therapy.~        3. Hypothesis: Metoclopramide at the dose of 0.5 mg/kg (max dose 20 mg) will be more~          effective than ondansetron, diphenhydramine, or placebo as rescue therapy.~   "
190747|NCT01067664|"~     This observational study attempts to investigate the potential role of serum progesterone~     levels on the day of hCG administration (thus, the end of the follicular phase) on the~     probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and~     recombinant gonadotrophins.~      There has been evidence, that increased serum levels of progesterone are associated with a~     decreased probability of pregnancy after IVF.~      This study will attempt to explore the role of progesterone on the outcome of IVF, by closely~     monitoring its levels during the late follicular phase.~   "
190748|NCT01067651|"~     The purpose of this study was to determine the influence of cast material on correction of~     congenital idiopathic clubfeet using the Ponseti method.~   "
190749|NCT01067638|"~     The Effect of Tranexamic Acid on Postoperative Blood loss and Coagulation in Patients with~     Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft; double blind randomized~     control study.~   "
190750|NCT01067625|"~     This study is a prospective single-arm, multicenter study to evaluate the safety and~     effectiveness of the TOGA® Procedure for the treatment of morbid obesity.~   "
190751|NCT01067599|"~     The research project will determine the level of nicotine in ST products that will lead to~     the greatest reduction in toxicant exposure~   "
190752|NCT01067586|"~     The extent of toxicity varies considerably across different brands of smokeless tobacco (ST)~     products and data suggest that greater toxicity may result in greater health risks. However,~     little is known about the actual extent of exposure to toxicants from current smokeless~     tobacco products and factors that might moderate the extent of this exposure. The goals of~     this project are to address the following questions:~        1. What are the characteristics of the range of smokeless tobacco products in current use~          and how do these products impact user behavior;~        2. What are novel and the best measures of smokeless tobacco use, behavior and exposure;~          and~        3. What are some of the determinants of smokeless tobacco use.~   "
190753|NCT01067573|"~     To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and~     change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple~     sclerosis patients.~   "
190788|NCT01067118|"~     The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to~     Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a~     breakfast meal.~   "
190754|NCT01067560|"~     This study will determine the level of glucose (sugar) in the CSF (fluid that surrounds the~     spinal cord) in 30 subjects having spinal anesthesia for cesarean section using a bedside~     glucose meter. Spinal anesthesia is done by injecting drugs through a needle into the CSF.~     Subjects will have 1/10 tsp of CSF removed at the time of spinal anesthesia to measure the~     level of glucose. Glucose meters measure glucose, usually in the blood, and they can be used~     in the operating room. This study will see whether a glucose meter will easily measure the~     level of glucose in CSF.~   "
190755|NCT01067547|"~     Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or~     intravenous route in Inflammatory Bowel Disease patients.~      Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD)~     and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment~     options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron~     replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor~     quality of life, poor concentration span and low energy level. Blood transfusion may improve~     symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born~     infection transmission. Moreover, packed cells are scarce resource therefore its use needs to~     be carefully prioritized. Oral iron supplement has been widely used and it can be purchased~     over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly~     tolerated with side effects include altered bowel habit, nausea and darken stools, making it~     difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to~     replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has~     been supported by its post marketing surveillance. Limitations with intravenous iron~     replacement include the need for medical supervision in the setting of limited healthcare~     resources; the need for patients to take multiple days off work and the cost of Venofer®.~     Currently it is uncertain which method of iron replacement is better. The purpose of this~     study is to compare the efficacy and the cost of oral and intravenous iron replacement in the~     setting of iron deficiency anaemia.~   "
190756|NCT01067534|"~     Studies evaluating response to bronchodilation in flow-volume spirometry and/or by forced~     oscillations technique (FOT), have been conduced in subjects with obstructive airways~     diseases. Less is known about bronchodilation responses, assessed by both spirometry and FOT~     in healthy young subjects.~      The purpose of the present study is~        1. to determine the range of the bronchodilation response in terms of changes in selected~          spirometric parameters in healthy non-smoking young adults, for identifying normal~          response after an inhaled bronchodilatory agent versus placebo, and its anthropometric~          and spirometric determinants~        2. to determine the range and characteristics of bronchodilation response using~          pseudorandom FOT in healthy non-smoking young adults, for identifying normal response~          after an inhaled bronchodilatory agent versus placebo, and its anthropometric and~          oscillometric determinants.~        3. to compare and correlate eventual changes in spirometric and oscillometric parameters.~      The investigators hypothesize that exists a normal variation in spirometric and oscillometric~     parameters after bronchodilation, and that these parameters are correlated.~   "
190757|NCT01067521|"~     The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg~     administered three times a week compared to placebo in subjects with RRMS, as measured by the~     number of confirmed relapses during the 12 month placebo controlled phase. The study has two~     phases:~        -  Placebo Controlled Phase: 12 months of 40 mg administered three times a week by~          subcutaneous injection or matching placebo.~        -  Open Label Extension: All subjects will continue treatment with GA 40 mg administered~          three times a week, until this dose strength is commercially available for the treatment~          of relapsing remitting multiple sclerosis (RRMS) patients or until the development of~          this GA dose regimen is stopped by the Sponsor~   "
190758|NCT01067508|"~     The aim of this research study is to determine by laboratory analyses the effects of drinking~     silicon-rich water on bone health. This will be determined from blood and urine samples from~     subjects who will be asked to drink 1 liter per day of either silicon-rich water or water~     without silicon for 12 weeks.~   "
190759|NCT01067495|"~     Despite the similarities between heart disease and stroke in terms of disease process and~     elevated risk of recurrent events, exercise-based programs akin to cardiac rehabilitation are~     not available for people with stroke.~      The purpose of this study is to examine 1) the feasibility of adapting cardiac rehabilitation~     for individuals with stroke, and 2) the effects of this program on aerobic capacity, walking,~     risk factors, community integration and quality of life.~      The investigators anticipate that cardiac rehabilitation may be appropriately adapted to~     accommodate individuals with stroke who have a range of functional abilities, and that this~     program is effective in improving aerobic capacity, walking ability and stroke risk factors.~     The investigators also anticipate participants will demonstrate improved community~     integration and quality of life following this program.~   "
190760|NCT01067482|"~     The purpose of this study is to evaluate performances of each parameters of spectral domain~     (Cirrus) optical coherence tomography for distinguishing between normal eyes, glaucoma~     suspect and glaucomatous eyes~   "
190761|NCT01067469|"~     The goal of this clinical research study is to learn if the combination of bevacizumab and~     lomustine can help to control glioblastoma. The safety of this combination will also be~     studied.~   "
190762|NCT01067456|"~     The purpose of this research is to determine the efficiency of a single dual source computed~     tomography (CT-DSCT) protocol to establish or exclude acute coronary syndrome (ACS),~     pulmonary embolism (PE) or aortic dissection (AD) as compared to the individual protocols.~     Endpoints aim to compare the rate of emergency department (ED) discharge, length of hospital~     stay, the diagnostic imaging test utilization, and the costs between the comprehensive and~     the standard protocol strategy in patients with undifferentiated chest discomfort or~     shortness of breath with a component of chest discomfort.~   "
190763|NCT01067443|"~     This study is to assess if shorter combinations of SSG plus single dose AmBisome®,~     Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating~     visceral leishmaniasis in Eastern Africa.~   "
190764|NCT01067430|"~     The purpose of this study is to explore the effect of Etoricoxib compared to Diclofenac on~     physical activity in RA subjects with early morning pain and stiffness.~   "
190765|NCT01067417|"~     The purpose of this pilot study is to find out if taking hydroxychloroquine will decrease~     immune activation (stimulation of the body's defence system) in people with early HIV~     infection. Hydroxychloroquine is a medicine that has been used successfully for many years to~     treat autoimmune diseases (diseases in which the immune system causes damage to the body),~     e.g. lupus and rheumatoid arthritis. It is generally safe in long-term use and easily~     accessible.~      The immune system is stimulated in response to infections including HIV, so treatments that~     decrease immune activation may have long-term clinical benefits i.e. delay onset of~     treatment.~   "
190766|NCT01067404|"~     Each winter, viruses belonging to two kinds of influenza A (A/H1N1 & A/H3N2) and two~     kinds of influenza B (B/Yamagata & B/Victoria) can cause illness. The yearly influenza~     vaccine is designed to protect against both kinds of influenza A but only one or the other~     kind of influenza B. The vaccine is changed from year to year, meaning it may include one~     kind of B virus one year and the other kind another year. But because influenza is so hard to~     predict, sometimes the kind of B virus chosen for the vaccine may not match the kind that is~     causing illness. The National Advisory Committee on Immunization recommends that all infants~     and toddlers receive influenza vaccine to protect against their high rates of~     hospitalization. Infants/toddlers receiving influenza vaccine for the first time must get two~     doses (prime plus boost) to have a good antibody response. If they have ever before received~     a single dose of influenza vaccine, then they are recommended to receive only one dose each~     year afterwards. But we don't know how well previous doses of one kind of influenza B set the~     stage for good antibody response to a single dose of the other kind of influenza B. This~     study will try to answer that question in a group of infants/toddlers who last year received~     two doses of one kind of B virus (Yamagata), as part of another study. This year, we will~     give them a single dose of influenza vaccine that now contains the other kind of B virus~     (Victoria) and see how much antibody they make to both kinds. About half these children~     received a higher amount of influenza vaccine in the previous year's study, so we will also~     compare their antibody levels on that basis. Since influenza B is an illness especially of~     children, understanding how to best protect infants/toddlers against both kinds of influenza~     B is important. This study will help us know if we need to design a new vaccine that not only~     includes both kinds of influenza A, but also both kinds of influenza B.~   "
190767|NCT01067391|"~     To address the effect of tadalafil (Cialis) on the cardiovascular system of men with complete~     spinal cord injury at T-6 and above. The hypothesis is that tadalafil will cause significant~     hypotension in people with tetraplegia.~   "
190768|NCT01067378|"~     Crisis management is important for operating room practice and non-technical skills are~     acknowledged as key to ensure patient safety in these situations. Unfortunately, it can be~     difficult to find instructors with appropriate experience. A peer-led team debriefing is led~     by the team it self rather than an external expert instructor but remains a reflective~     process. Incorporating peer-led debriefing compared to expert-led debriefing may increase~     access to an interprofessional crisis resource management course using simulation.~      The goals of the study are to observe the effect of an interprofessional peer-led team~     debriefing in the change in performance of non-technical skills of team performance and to~     compare it with the gold standard of expert-led debriefing on the performance of~     non-technical skills during a simulated operating room crisis.~      The investigators hypothesize that interprofessional peer-led debriefing will improve the~     performance of non-technical skills of the team during simulated intraoperative crisis~     management and that this improvement will be equivalent to the gold standard expert-led~     debriefing.~   "
190769|NCT01067365|"~     Subjects who completed ZA-003 were eligible to receive an additional year of treatment in~     this extension study.~   "
190770|NCT01067352|"~     This open, multicentric, randomized, controlled study is planned to evaluate the correlation~     between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in~     SGA children.~   "
190771|NCT01067339|"~     AIM III is a prospective, randomized, double-blinded, placebo controlled trial. The study is~     directly connected to IRB 08-008161 as a specific aim of the National Institute of Health~     (NIH) grant. Participants may either consent to and qualify for AIM I and AIM II (IRB~     08-008161) or have a cardiac catheterization with acetylcholine testing in the Cardiac~     Catheterization Laboratory at Mayo Clinic in Rochester, Minnesota to be considered for this~     study.~   "
190772|NCT01067326|"~     We will study the hypothesis that long-term Tekturna treatment will improve endothelial~     function and the production and function of endothelial progenitor cells (EPCs) in patients~     with early atherosclerosis. Specifically, long-term Tekturna treatment will increase the~     Reactive Hyperemia Peripheral Arterial Tonometry indexes and increase the numbers and the~     function of circulating endothelial progenitor cells, compared to placebo, in association~     with a reduction in inflammation and oxidative stress.~   "
190773|NCT01067313|"~     This study aims to demonstrate equivalence in terms of molecule removal between continuous~     hemodialysis using an enhanced middle molecule clearance membrane(Ultraflux EMiC2) and~     continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients~     requiring continuous renal replacement therapy.~   "
190774|NCT01067300|"~     Unrelated cord blood transplantation (UCBT) has been used for several years when there is no~     HLA identical sibling or unrelated donor.Since the recent publication of encouraging results~     after transplantation of two UCB units, the number of these double-transplantations increases~     in a very significant way.However, there is currently no prospective study comparing in a~     reliable way the double-transplantation to single-transplantation results.The investigators~     propose a prospective and randomized study comparing the results of single versus double unit~     UCBT in children and young adults (< 35 yrs) with acute leukemia in remission. This is an~     open, multicenter study carried out in the allogeneic transplant centers from the French~     society for hematopoietic stem cell transplantation and cell therapy. The primary objective~     is to compare the incidence of transplantation failure in the two treatment arms.~     Transplantation failure, the primary endpoint of the study, is defined by the occurrence of~     one of the following events : transplant-related death, second allogeneic transplantation or~     autologous backup infusion for primary engraftment failure, autologous recovery. The~     financial impact of these double-transplantations being to date unknown, the project also~     includes a cost-effectiveness study, the effectiveness criterion being a decrease in~     transplantation failure incidence. The secondary clinical endpoints are: overall survival and~     disease-free survival, relapse incidence, transplant-related mortality, incidence of severe~     infections and GvHD. The secondary biological endpoints are: hematological and immunological~     recovery, post transplant chimerism.~   "
190789|NCT01067105|"~     6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147).~     Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered~     once-daily in patients with Perennial Allergic Rhinitis.~   "
190872|NCT01066013|"~     The purpose of this pilot study is to assess the impact of an antibiotic de-escalation~     strategy on the clinical outcomes (clinical cure or improvement) of medical patients related~     to the usage of of broad-spectrum antimicrobial agents.~   "
190775|NCT01067287|"~     The purpose of this research study is to determine the safety of CT-011 alone, as well as the~     combination of the Dendritic cell fusion vaccine and CT-011, after autologous stem cell~     transplantation (ASCT). We are also trying to find out what effect the combination has on the~     disease, including if it is more successful in preventing or delaying the disease from coming~     back, compared to treatment with autologous transplantation alone. ASCT is a standard therapy~     for multiple myeloma that is often successful in significantly decreasing the amount of~     cancer in the body. CT-011 is an investigational monoclonal antibody. Monoclonal antibodies~     are a type of drug given by infusion into a vein and are known to target specific cells (in~     this case, cells in the immune system). The dendritic cell fusion vaccine is an~     investigational agent that tries to help the immune system to recognize and fight against~     cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines~     are being studied to see if they can fight cancers that are already in the body.~   "
190776|NCT01067274|"~     A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid~     (ATRA) in Combination with Induction Chemotherapy, or Azacitidine and Idarubicin as salvage~     therapy and Idarubicin with Cytarabine or Azacitidine as Maintenance Therapy in Older~     Patients with Acute Myeloblastic Leukemia (AML).~      To compare the outcome of elderly patients with newly-diagnosed AML treated with standard~     induction chemotherapy and post-remission therapy, in only patients in CR, with either~     azacitidine or cytarabine combined to idarubicin +/- ATRA and salvage therapy with~     azacitidine combined to idarubicin +/- ATRA.~   "
190777|NCT01067261|"~     After radical prostatectomy nerve damage in the pelvic floor usually occurs. This causes side~     effects in the form of incontinence and erectile dysfunction.~      It has previously been shown that one can stimulate the nerves of the pelvic floor by means~     of transcutaneous mechanical nerve stimulation (TMNS) done through vibration. This study will~     examine the effect of TMNS in the preservation and restoration of urinary continence and~     erectile function and in the treatment of urinary incontinence and erectile dysfunction in~     conjunction with radical prostatectomy.~      The theory is that by means of TMNS one can stimulate the nerves of the pelvic floor and the~     penis which may improve their function and there by prevent or minimize the occurrence of~     incontinence and erectile dysfunction following pelvic surgery. Vibration may also help to~     eliminate these symptoms once they have occurred. It is possible that TMNS will also directly~     increase the blood flow in the cavernosal tissue thus aiding in the preservation of this~     tissue. In case the improved nerve function is not great enough to secure satisfactory~     erectile function in itself it may still improve the effect of PDE-5-inhibitors.~      In pilot studies TMNS has already shown an effect in the treatment of urinary continence.~      In this study the patients will be randomized to either TMNS treatment or no TMNS treatment.~     In both groups the patients will participate in a pelvic floor muscle training program. In~     the group receiving active treatment this will be supplemented by TMNS treatment. The two~     groups will be evaluated and compared with regard to erectile function time to continence~     after surgery.~   "
190778|NCT01067248|"~     The main objective is to study important factors in the patho-physiology of osteoporosis in~     patients with COPD. Therefore, the investigators will study biological markers in plasma and~     urine and correlate them to markers of bone turnover and clinical data.~   "
190779|NCT01067235|"~     The objective of this study is to evaluate and compare the efficacy and safety of escalating~     doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy~   "
190780|NCT01067222|"~     The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by~     individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)~   "
190781|NCT01067209|"~     The overall purpose of this study is to evaluate the effect of gastric bypass surgery-induced~     weight loss on the heart's function and on fat deposits in the heart muscle.~   "
190782|NCT01067196|"~     The purpose of this study is to collect information from medical records to see what effects~     proton beam radiation has on cancer and analyze possible side effects.~   "
190783|NCT01067183|"~     Given the nature of their work duties and work environment, physicians often experience~     stress within the workplace and chronic stress negatively impacts physician wellness.~     Physician wellness is now linked to quality of patient care. The stress response can be~     broken down into four components: the stressor, the reaction, the physiological response and~     the experience of the physiological response. Stress can also be absolute (e.g. threat to~     life) and relative (e.g. I have 3 more consults to see). Stress management refers to a range~     of processes that are intended to mitigate one or more aspects of the psychobiology of~     stress. Biofeedback is a useful way of providing guidance and reinforcement for successful~     management of the physiological response to stress. It is important to provide physicians~     with effective tools for stress management. The objective of this study is to compare~     measures of stress and well-being among physicians allocated to learn a relaxation breathing~     technique and to use a biofeedback tool (referred to as a portable stress management device~     or PSMD) for 28 days (intervention group) and those allocated to standard care for 28 days~     (control group).~   "
190784|NCT01067170|"~     This study aims to determine the effect of pneumatic compression devices (PCDs) on central~     blood volume in hemodialysis patients. We hypothesize that PCDs will help maintain central~     blood volume, and therefore prevent sudden decreases in blood pressure during hemodialysis.~   "
190785|NCT01067157|"~     The purpose of the study is to determine the genetic influence on short-, middle- and~     longterm effects of an inpatient lifestyle therapy program in overweight and obese children~     and adolescents.~   "
190786|NCT01067144|"~     The goal of this study is to determine whether administering Gabapentin prior to surgery~     affects duration of pain and opioid use post-surgery. The investigators aim to compare~     gabapentin to placebo in a prospective, randomized clinical trial in which patients will be~     followed post-surgery until pain resolves and opioid use ceases.~   "
190787|NCT01067131|"~     Pevion Biotech develops a state-of-the-art vaccine against recurrent vulvovaginal candidiasis~     (RVVC) caused by the pathogenic form of Candida albicans especially in pre-menopausal women~     of childbearing age with a history of recurrent vulvovaginal candidiasis. This study is~     designed to evaluate the safety and tolerability of the vaccine, administered by two~     different routes (intramuscular and intravaginal) as primary endpoint. Immunogenicity will be~     evaluated as secondary endpoint.~   "
190790|NCT01067092|"~     The MATCH study (Mexican-American Trial of Community Health Workers) tests the hypothesis~     that the use of indigenous Community Health Workers (CHWs), recruited from the target~     community and trained to provide culturally appropriate diabetes education, can promote~     pro-active self-management among inner-city dwelling Mexican-Americans with Type 2 diabetes~     mellitus. The study aims are to demonstrate that a CHW, compared to an attention control,~     will: 1) result in improvement in short term physiologic outcomes (Hemoglobin A1c levels and~     blood pressure), and 2) result in increased frequency of self-management behaviors (daily~     self blood-glucose monitoring, medication adherence, adherence to diet and physical activity~     recommendations). The study design is a single site, partially blinded, randomized controlled~     trial of 144 patients with Type 2 diabetes mellitus.~      Eligibility criteria include a diagnosis of Type 2 diabetes, residence in target community~     areas in the Chicago area, and Mexican or Mexican-American ethnic heritage. Participants are~     randomized to either an experimental group receiving 36 home visits over a two year period in~     which a CHW delivered diabetes education and self-management skills training, or to an~     attention control consisting of 36 bilingual diabetes education newsletters covering the same~     curriculum as the CHWs. The curriculum covers recommended diabetes self-management behaviors~     including glucose self-monitoring, responding to abnormal blood glucose levels, working~     effectively with health care providers, medication adherence, foot care, daily physical~     activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills~     of self-monitoring, environmental restructuring, engagement of social support, stress~     management, and problem-solving skills to facilitate the self-management activities.~     Consistent delivery of the CHW intervention is documented by audiotapes and Documentation of~     Intervention worksheets.~   "
190791|NCT01067079|"~     This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5~     years after initial vaccination, administered in two different post-exposure vaccination~     schedules~   "
190792|NCT01067066|"~     The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI~     287 that can be given in combination with Temodar (temozolomide) to patients with metastatic~     melanoma.~      The goal of the Phase II portion of this study is to learn if TPI 287, given in combination~     with temozolomide, can control metastatic melanoma. The safety of this combination will also~     be studied. NOTE: Study stopped before progressing to Phase II portion.~   "
190793|NCT01067053|"~     The purpose of this study is to determine whether bevacizumab, capecitabine and oxaliplatin~     are an effective and safe first line of treatment for elderly patients with metastatic~     colorectal adenocarcinoma.~   "
190794|NCT01067027|"~     It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed~     infants with colic.~   "
190795|NCT01067014|"~     The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in~     reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis~     that requires surgery.~   "
190796|NCT01067001|"~     To determine single-dose oral bioequivalence of Minocycline HCl Extended Release Tablets 135~     mg manufactured by Amneal Pharmaceuticals Co.(I)Pvt. Ltd., India and SOLODYN® (minocycline~     hydrochloride) Extended Release Tablets 135 mg Manufactured for Medicis, The Dermatology~     Company, Scottsdale, AZ 85256, by Wellspring Pharmaceutical Canada Corp., Oakville, Ontario~     L6H 1M5 in normal, healthy, adult, human subjects under fasting condition.~   "
190797|NCT01066988|"~     The purpose of this study is to evaluate the effects of an investigational lubricant eye drop~     on tear film lipid layer thickness of dry eye patients.~   "
190798|NCT01066975|"~     Soldiers and recreational backpackers are often required to carry heavy loads on their body~     during military operations or hiking. Despite the advances in backpack design, the loads~     carried by soldiers still impose an extreme physiological strain (soft tissue deformation)~     which frequently results in discomfort, pain,musculoskeletal injuries, and loss sensorimotor~     function.~      In the current study, characterization of the pressures, evaluation of the deformations of~     the soft tissues, specifically the fat, muscles, Brachial plexus and subclavian vessels~     applied on the shoulder while sitting with a heavy backpack will performed. The data acquired~     in the current trials will be used for development of a finite element (FE) 3D shoulder~     model. The purpose is to better understand the mechanical loads that are being transferred to~     the underlying tissue below the shoulder straps during walking/marching with a backpack.~     During the 2nd phase of this project, data collected during this research will be used to~     develop gear that will alleviate the strain on the shoulders, prevent injury, and enhance~     performance.~      Hypothesis~        -  High focal strain (hot-spots) on the shoulder tissue that are observed with the pressure~          mapping will be observed also in the MR scans.~        -  The strain at those hot-spots can be reduced by personal-geometry adjusted straps.~      Volunteers~      Five young (18-30 yrs), healthy, and fit males will participate in this study.~      Trials design~        1. MR Scans- The scan will be performed for analysis of personal shoulder anatomy, and will~          be used for developing a 3D FE model. The sagittal view will be used to develop the 3D~          model. The coronal and axial sectional views will be used to assess the deformations~          applied on the shoulder tissue. The scan will then be repeated while carrying a 25 kg~          standard commercial backpack while sitting in the same position, for the assessment of~          shoulder girdle tissues deformations. Time estimation for each scan is 40 min (80 min~          total). The subjects are not required to carry the backpack prior to those scans.~        2. Static pressure measurement- each volunteer will be asked to sit for 30 seconds while~          carrying the 25 kg backpack. During this session, pressure will be measured using a~          pressure mapping pad (Sensor Products Inc., USA) placed between the shoulder strap and~          the underlying tissue.~      The maximal total participation time of each volunteer will be 2 hours total (inside and~     outside the MR).~      Data acquired in the current trials will be used for the development of a FE (finite element)~     3D shoulder model. MR scans will be utilized for composing geometry and for the boundary~     conditions assessment (strain magnitude). Pressure measurements will be used as boundary~     conditions (stress magnitude).~      MR scans and pressure measurements will be performed in the Sheba medical center facilities.~   "
190799|NCT01066962|"~     The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant~     first-line treatment option in the years to come. The dual combination of boosted darunavir +~     raltegravir is an innovative treatment option that combines two potent new antiretroviral~     drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy~     profile of this combination is promising. Moreover, this combination might have a better~     tolerance profile and has the advantage of sparing the NRTI class.~      In the context of tenofovir/emtricitabine currently being a reference backbone in first-line~     antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir~     may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.~   "
190810|NCT01066819|"~     This observational study will assess predictors of early on-treatment and sustained~     virological response in treatment-naïve patients with chronic hepatitis C initiated on~     treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data~     will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the~     end of treatment. Target sample size is <2000.~   "
190811|NCT01066806|"~     SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to~     recommended levels with dairy foods in adolescent females with habitually low calcium intake~     and above-the-median body mass index (BMI) for sex and age will decrease body fat gain~     compared to similar females who continue their low calcium intake. .~      HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume~     dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in~     percent body fat, as measured by dual energy absorptiometry, during one year than~     post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.~   "
190893|NCT01065727|"~     Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone~     followed by immunomodulator) in the management of aggressive remitting multiple sclerosis~   "
190800|NCT01066949|"~     The aim of the proposed work is to conduct a randomized controlled trial (RCT) evaluation of~     a behavior change intervention designed to enhance fluid-intake adherence (compliance) among~     hemodialysis patients. Patient non-adherence (non-compliance) with fluid-intake restrictions~     is a highly pervasive problem in the hemodialysis population with substantial consequences in~     terms of increased patient morbidity and mortality. Given the prevalence and clinical~     importance of adherence among ESRD patients, the design and evaluation of interventions to~     improve patient adherence is critically important. Surprisingly, however, little such~     empirical work has been conducted in this area.~      The proposed RCT involves testing the efficacy of a behaviorally based, group-administered,~     behavioral self regulation intervention designed to increase adherence to fluid intake~     restrictions among hemodialysis patients. This structured intervention is designed to be~     delivered by healthcare providers in a clinical setting to groups of 4-10 patients over~     seven, one-hour weekly sessions. This study will compare the effect of the structured~     intervention group with the effect of an educational and support group on fluid-intake~     adherence in a sample of approximately 200 fluid non-adherent center hemodialysis patients~     over a 26-week follow-up period. Both clinical (interdialysis session weight gain) and~     self-report indices of fluid-intake adherence will be examined. We believe that the proposed~     research is of potentially very high impact given the high prevalence and clear clinical~     consequences of hemodialysis patient nonadherence and the potential for a relatively~     low-cost, structured intervention to significantly reduce this type of maladaptive patient~     behavior in the hemodialysis treatment context.~   "
190801|NCT01066936|"~     The objective of this study is to evaluate the bone ingrowth after implantation of the study~     device. This study will also document any device-related surgical complications or adverse~     radiographic observations. Improvement in pain, function, and health economic data will be~     compared with improvements documented with other joint systems.~   "
190802|NCT01066923|"~     The purpose of this study is to determine if aspirin taken by firefighters prevents platelets~     from becoming sticky when body temperature rises during work in protective clothing.~   "
190803|NCT01066910|"~     The objective of this study is to test and evaluate the effectiveness of a parent-only~     treatment for childhood obesity. This study provides state-of-the-art treatment for childhood~     obesity. Parents and children will participate in treatment groups for 6 months. These~     treatment groups include recommendations to decrease overall caloric intake (by increasing~     fruits and vegetables), increasing physical activity, decreasing sedentary behavior and~     changing the home food environment. We are currently implementing this treatment in the~     Healthy Choices Program which is part of the Childhood Obesity Clinic at the University of~     Minnesota. Len Epstein at the University of Buffalo has been publishing on this treatment~     protocol for 30 years.~   "
190804|NCT01066897|"~     We hope to learn how a brain circuit that is important to the understanding of depression,~     anhedonia and positive affect responds to a novel pharmaceutical treatment for depression and~     related symptoms. Adults who have a diagnosis of major depression and are not completely~     responsive to antidepressant medication will be sought out for participation; as will an~     equal number of adults not suffering from the disorder. Those suffering from depression will~     be given pramipexole, an investigational medication for eight weeks during which information~     will be collected about mood, cognition, and brain function. Adults not suffering from~     depression will also be evaluated with these measures.~   "
190805|NCT01066884|"~     This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients~     with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The~     anticipated time on study treatment is until disease progression, and the target sample size~     is 100-500 individuals.~   "
190806|NCT01066871|"~     Several people all over the world suffer from cartilage injuries in the knee. Symptoms~     include pain, joint swelling, and loss of function. Without repair, cartilage injury may~     ultimately lead to osteoarthritis (OA). Natural healing is poor, and to date treatment is~     available only for deep cartilage defects involving also the underlying bone. A promising~     candidate for drug treatment of cartilage injury is sprifermin (AS902330), a recombinant form~     of the human fibroblast growth factor (FGF) 18.~      So far, the drug has been used in subjects with different stages of knee OA in two ongoing~     studies without emerging safety issues following single and multiple intra-articular~     injections of ascending doses. However, OA represents late-stage cartilage injury, where~     repair might be difficult due to diffuse damage, reduced responsiveness of the cartilage,~     and/or the involvement of other joint structures.~      This clinical trial is meant to provide the proof of concept and to identify an efficacious~     dose of sprifermin (AS902330) for the treatment of adult subjects with acute cartilage~     injuries of the knee. The first subject for this trial was treated on the 19th of April 2010.~   "
190807|NCT01066858|"~     The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an~     anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and~     while breastfeeding. The study will also look at the changes in overall health, bone health~     and how the kidneys work in the infants of these women.~   "
190808|NCT01066845|"~     To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary~     Arterial Hypertension (PAH) patients in the clinical practice －focused topics－~        1. To evaluate the incidence of adverse events for the patients with long-term use~        2. To evaluate the incidence of adverse events of decreased blood pressure, bleeding~          (including uterine hemorrhage), visual disturbance and sudden hearing loss.~   "
190809|NCT01066832|"~     The primary objective of this multi-center, international, short term registry is to assess~     clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent~     restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse~     cardiac events (MACE: death, myocardial infarction [MI], target lesion revascularization~     [TLR]) and target vessel revascularization [TVR]) and stent thrombosis, both early and late~     occurrences will be assessed.~      In addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to~     assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel~     eluting balloon treatment for in-stent restenosis.~      A prioi analysis will be comparison of the safety and efficacy of patients presenting with~     drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.~   "
190812|NCT01066793|"~     This observational study will assess predictors of early on-treatment and sustained~     virological response in treatment-naïve patients with chronic hepatitis C initiated on~     treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data~     will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the~     end of treatment. Target sample size is <2000.~   "
190813|NCT01066780|"~     The purpose of this study is to collect information about how the new sound-processing~     affects the ability to hear in everyday listening situations.~   "
190814|NCT01066767|"~     Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg~     Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets aventis Administered~     as~      1 x 180 mg Tablet in Healthy Subjects under Fed Conditions~   "
190815|NCT01066754|"~     Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg~     Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets, Aventis Administered~     as 1 x 180 mg Tablet in Healthy Subjects under Fasting Conditions~   "
190816|NCT01066741|"~     The purpose of this study is to evaluate the benefit of a mouthwash with a~     phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing~     sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in~     patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer.~      This is a phase III, controlled, randomized, single blind study. The estimated inclusion~     period is approximately 24 months. The number of patients required in this monocentric study~     is 330 (165 per arm).~   "
190817|NCT01066728|"~     The objective of the present proposed study is to discover whether, in the nursery setting,~     administration of low concentration inhaled CO2 (0.8%) for a prolonged period (3 days) can~     make breathing more regular with less apneic time than that observed with administration of~     theophylline. The hypothesis to be tested is that inhalation of low concentration CO2 (0.8%)~     will reduce apnea more effectively and will have fewer adverse side effects than~     theophylline.~   "
190818|NCT01066715|"~     The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2~     Diabetes.~      Study X052078 is designed to establish efficacious dose(s) for future studies based on~     improvement in HbA1c.~   "
190819|NCT01066702|"~     This confirmatory study is a prospective randomized trial comparing the efficacy and safety~     of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention~     microfracture in the treatment of cartilage defects in the knee.~   "
190820|NCT01066689|"~     Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a~     composite TREATMENT FAILURE~   "
190821|NCT01066676|"~     Medical condition under investigation: Osteoarthritis of the hip or knee~      Number of patients planned: 480 adult patients~      Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg~     powder for oral suspension compared to Ibuprofen 400 mg in patients with painful~     osteoarthritis of the hip or knee~      Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for~     oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints~     due to painful osteoarthritis of the hip or knee~   "
190822|NCT01066663|"~     In this research study we will start by looking for the highest dose of pyrimethamine that~     can be given safely to CLL patients without severe or unmanageable side effects. This dose~     will then be used for a larger Phase II study to assess the efficacy of pyrimethamine for the~     treatment of CLL/SLL. Pyrimethamine is an antibiotic that is used for the treatment of~     certain infections. Previous research studies have shown that pyrimethamine may target a~     protein in tumor cells, called STAT3, which may be important for the growth of chronic~     lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) cells. Pyrimethamine can kill~     CLL/SLL cells in the laboratory, and we are therefore undertaking this study to assess~     whether pyrimethamine will result in clinical benefit or tumor responses in CLL in patients.~   "
190823|NCT01066650|"~     The TWENTE Study is a single center prospective single-blinded randomized study.~     Randomization will involve the type of Drug-Eluting Stent (DES) used in study population.~     Patients will be blinded to the type of DES they will receive. The general practitioner of~     the patient will be requested not to disclose this information to the patient. Analysts who~     perform the data analyses will be blinded to the type DES used as well.~   "
190824|NCT01066637|"~     The primary purpose of this study is to measure the level of an enzyme in a patient's heart~     called inducible nitric oxide synthase(iNOS) using Positron Emission Tomography (PET) imaging~     with a radioactive tracer called 18F-NOS. These PET results will be compared to tissue~     results obtained during routine endomyocardial heart biopsy. The enzyme iNOS produces nitric~     oxide in inflammatory diseases such as acute heart transplant rejection, diabetes,~     Alzheimer's and cancer. Thus, PET with the radioactive tracer 18F-NOS may be a useful tool~     for detecting the early stages of these diseases. The safety of 18F-NOS during the study will~     also be assessed. All PET imaging will be performed with a CTI/Siemens Biograph 40 PET/CT~     scanner. Protocol was revised to add new imaging modality, Biograph mMR PET-MR scanner in~     order to investigate new hardware and software in order to optimize scanning procedures in~     order to refine image quality so that we can apply the findings to future standard clinical~     scans and research imaging studies. Ten additional status-post OHT patients who are scheduled~     for standard of care endomyocardial biopsy for allograft rejection surveillance will undergo~     PET/MR imaging with [18F](+/-)NOS.~   "
190843|NCT01066390|"~     This phase I study plan is divided in the following four phases:~        -  Eligibility Screen Phase (week -4 to -1): Following written informed consent patients~          with metastatic melanoma (AJCC stage III/IV with unresectable disease) will undergo an~          eligibility screen (incl. blood analysis and PET/CT-scan).~        -  TriMix-DC Vaccine Manufacturing Phase (week I to IV): eligible patients will undergo a~          leucapheresis (15 liter of venous blood) for the preparation of autologous TriMix-DC~          vaccine. Vaccine preparations will be manufactured and quality-controlled (during an~          interval of 4 weeks following the leucapheresis) and released for patient administration~          if the TriMix-DC preparation fulfills the predefined quality requirements.~        -  TriMix-DC Vaccine Administration Phase (Week 1 to 24): 4 weeks after the leucapheresis~          patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID~          administration. The vaccines will be administered at 4 different visits that will be~          separated with an interval of 2 weeks. At each vaccination a total of 12.106 DC per~          antigen will be administered.~        -  Patients will be allocated to three different cohorts:~             -  The first cohort will receive 10% of TriMix-DC by iv and 90% by id injection.~             -  The second cohort 25% by iv and 75% by id injection.~             -  The third cohort 50% by iv and 50% by id injection.~        -  During the week following the administration of the fourth vaccine (= week 8), a~          DTH-test and punch biopsy of the injection site will be performed as well as a second~          leucapheresis (for the purpose of immuno-monitoring) and tumor evaluation (by PET-CT).~        -  A fifth vaccine will be administered and a repeat tumor staging performed in week 16 (=~          8w after the fourth vaccine).~        -  End of study visit: Patients will perform an end of study visit 8 weeks after the~          fifth vaccine (= week 24) as well as a new tumor evaluation (PET/CT).~        -  Follow-up Phase: survival data will be obtained until 3 years after the initiation of~          vaccine therapy or the time of death.~   "
190825|NCT01066624|"~     Chemotherapy-induced oral mucositis is the inflammation of the oral mucous membranes, which~     are tissues that line the mouth. Oral mucositis is caused when chemotherapy attacks and kills~     the rapidly-dividing cells in the oral mucous membranes. This condition feels like sunburn~     (or heartburn) on the mucous tissues, and often leads to sores in the mouth or on the tongue.~     This can cause discomfort, pain, difficulties in eating, and a longer hospital stay. Several~     therapies appear to either prevent or reduce the severity of mouth ulcers caused by~     chemotherapy for multiple myeloma. Different strategies are used to try and prevent this~     condition; a small number of trials found that some of these strategies may be effective.~     None of the trials had compared head to head the use of saline solution (our standard of~     care), cryotherapy (ice chips) and Caphosol in patients receiving high-dose melphalan.~      The goal of this research study to evaluate the effectiveness of saline solution,~     cryotherapy, Caphosol for the prevention of oral mucositis in patients with multiple myeloma~     receiving high-dose chemotherapy followed by autologous hematopoietic stem cell~     transplantation.~      The researchers hope to learn if there are any differences among saline solution, cryotherapy~     and Caphosol mouth rinse for the prevention of oral mucositis.~   "
190826|NCT01066611|"~     The purpose of this study is to determine the safety and effect of CAL-263 in subjects with~     allergic rhinitis.~   "
190827|NCT01066598|"~     The purpose of this study is to determine the efficacy of the combination of rituximab and~     prednisone as initial therapy for chronic graft-versus-host disease (C-GVHD).~   "
190828|NCT01066585|"~     The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective~     treatment for head lice infestations.~   "
190829|NCT01066572|"~     This study aims to investigate the use of lisinopril to lower blood pressure in stroke~     patients, pre-hospital, by research-trained paramedics.~   "
190830|NCT01066559|"~     The aim of this study is to improve the humoral immune response efficiency of hemodialyzed~     patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model~     of anti-HBV vaccination~   "
190831|NCT01066546|"~     The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in~     subjects with moderate-to-severe Alzheimer's Disease.~   "
190832|NCT01066533|"~     The purpose of this study is to evaluate the response of human dental pulp to capping with~     MTA and NEC by histology and immunohistochemistry, using fibronectin and tenascin as markers,~     following 2 weeks and 8 weeks.~   "
190833|NCT01066520|"~     The objective of this study is to determine the efficacy of Traumeel S (both ointment and~     gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained~     ankle.~   "
190834|NCT01066507|"~     The purpose of the study is the identification of amplification level in human breast tissue.~     The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classification of Her2 FISH stained tissue samples.~   "
190835|NCT01066494|"~     A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413)~     in combination with cytarabine in treating patients with acute myeloid leukemia (AML)~   "
190836|NCT01066481|"~     The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the~     treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study~     enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients~     completing the 6-month study will be eligible to receive PF-01913539 in an open-label~     extension trial (B1451031).~   "
190837|NCT01066468|"~     This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to <4~     years of age to help develop dosing regimens~   "
190838|NCT01066455|"~     The purpose of the research study is to evaluate different cardiac measures that are obtained~     by echocardiographic tests in patients with muscular dystrophy.~   "
190839|NCT01066442|"~     To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the~     long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649~     in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's~     Disease.~   "
190840|NCT01066429|"~     Poor prognosis dufuse large B-cell lymphoma (DLBCL) represents 50% of all DLBCL with overall~     cure rates ranging from 50-60% with modern dose-dense immunochemotherapy regimens such as~     R-CHOP14. Using an alternative strategy, as infusional and dose-adjusted R-EPOCH, the~     investigators have shown an 83% of complete responses (CR), with an estimated 5-year overall~     survival (OS) rate of 75% (García-Suárez et al. British Journal of Haematology 2007,~     136:276). Despite this improvement in outcome, the search for new treatment strategies should~     continue. Therefore, compared with prior R-EPOCH the investigators decided to investigate~     whether the introduction of dexamethasone (40 mg IV on days 1-5) in place of prednisone~     (based upon data which demonstrated that the former was associated with enhanced Central~     Nervious System penetration) and the reduction of treatment intervals from 3 to 2 weeks would~     be feasible and might improve the outcome in this group of patients.~   "
190841|NCT01066416|"~     It is unknown whether surgical treatment of chronic sinusitis improves asthma control in~     patients with poorly controlled asthma. This is a randomized trial of surgical plus medical~     sinus therapy versus medical therapy alone.~   "
190842|NCT01066403|"~     The objective of this study is to compare the modulation of pergolide, a D1/D2 receptor~     agonist, to placebo in non-acute schizophrenic subjects under concomitant therapy with~     atypical antipsychotics on specific PFC functions. Further aims are to assess the influence~     of pergolide on psychopathology and extrapyramidal symptoms in comparison to placebo.~   "
190866|NCT01066091|"~     The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial~     inflammatory response. It is supposed that there is a relationship between the postprandial~     inflammatory response and the repartition of fat and lean mass, which could partially explain~     the muscle mass loss with age.~      The aim of this study is to compare the inflammatory response of a normal meal or high fat~     meal (from different fatty acids sources) between young lean and young obese and aged lean~     and aged obese men.~   "
190867|NCT01066078|"~     This study used an external endocardial acceleration sensor (sonR sensor), placed on the~     patient's chest, to time the closure of aortic and mitral valves, and compared its~     performance with echocardiography.~   "
190844|NCT01066377|"~     Ageing dramatically affects immune function; this phenomenon is known as immunosenescence and~     partly explains the increased susceptibility for infection in older individuals. Vaccination~     is recommended to protect older people against influenza, but immunosenescence also reduces~     the efficacy of vaccination. Probiotics are beneficial bacteria, which can be consumed and~     which have a long and safe record of use in humans. Often they are taken together with~     prebiotics, which are carbohydrates that provide a food source for the beneficial bacteria~     when they reach the lower gut. There is particular interest in the positive influences of~     pre- and probiotics in older people, who are subject to alteration in gut microflora~     composition as well as immunosenescence.~      The PRIMAGE (Probiotics, immunity and ageing) study will examine the effect of a prebiotic~     and probiotic mix on the immune response to influenza vaccination in young and older~     subjects, and is funded by BBSRC DRINC. It will involve 60 young (18-35y) and 60 older~     (65-85y) subjects recruited from the local Reading community. Participants will take a pre-~     and probiotic mixture or a placebo for a total of 8 weeks. The probiotic is not currently~     commercially produced, but has been demonstrated to have particular ecological fitness and~     anti-pathogenic effects in the gastrointestinal tract in old age. A suitable prebiotic will~     be selected on the basis of ability to promote optimal growth and survival of this probiotic.~     After 4 weeks on the treatment, the subjects will receive an influenza vaccination. Blood,~     saliva and stool samples will be taken before treatment, and at 4, 6 and 8 weeks after~     commencement. The samples taken at 6 and 8 weeks will be used to assess the immune response~     to the vaccination. A wide range of immune parameters will be assessed, taking into account~     the age-related shifts in immune cell populations.~   "
190845|NCT01066364|"~     The purpose of the study is to see if the drug colesevelam is a potential treatment for~     Nonalcoholic Steatohepatitis(NASH).~   "
190846|NCT01066351|"~     The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention~     acute kidney injury in CKD patients undergoing cardiac surgery.~   "
190847|NCT01066338|"~     The most reliable prognostic marker of acute myeloid leukemia(AML) is cytogenetics by~     karyotyping. According to cytogenetic results, the patients with AML are classified as~     better, intermediate and poor prognosis groups. The normal karyotype AML was reported in~     about 50% of all AML and classified as intermediate risk group. However, the patients with~     normal karyotype AML showed various prognosis. Therefore, the further studies about subgroup~     analysis of normal karyotype AML are needed. Recently, the understandings of human genome~     polypmorphism using SNP array have been accumulated. However, the advanced researches for~     clinical application are not enough.~      The study design is a retrospective and single-center study. The patients with normal~     karyotyping AML who were diagnosed from 1994 to 2008 at Samsung Medical Center (South Korea)~     will be enrolled. The stored bone marrow samples of enrolled patients are used for genome~     wide scanning by SNP array.~      The purpose of present study is to develop predictive pharmacogenemic biomarkers model~     associated wit clinical outcomes including efficacy and toxicity in patients with AML with~     normal karyotype treated with chemotherapy using pharmacogenetic SNP array. And secondly, to~     develop enrichment clinical trial based on predictive pharmacogenomic model.~   "
190848|NCT01066325|"~     The objectives of this study are to investigate if Neuro Emotional Technique (NET) will~     impact back and leg flexibility over both the short-term and the long-term.~      It is hypothesized that NET will improve flexibility and that these changes are durable.~   "
190849|NCT01066312|"~     Manual Muscle Testing (MMT) practiced by over a million practitioners worldwide. However,~     it's accuracy under varying levels of blindness has not yet been considered. This study will~     test this accuracy.~      Study Hypothesis: MMT can accurately distinguish congruent from incongruent statements. Also,~     the accuracy of MMT is positively correlated with practitioner experience.~   "
190850|NCT01066299|"~     Oxytocin (OXT) is currently regarded as a crucial neuropeptide in the mediation of various~     human social behaviors, e.g. social affiliation, social recognition, and the modulation of~     anxiety, mood, and aggression. An impairment of social behavior, emotional regulation as well~     as increased stress reactions are characteristic of several psychiatric conditions, including~     schizophrenia, social anxiety and PTSD, in which there is also some evidence for OXT~     dysfunction. The startle reflex is a basic defensive reaction that can be modulated by~     emotional stimuli. The investigation of the startle reflex and of its modulation is a~     well-validated method to test stress reactions and emotional regulation. These processes are~     impaired in the same psychiatric diseases, in which OXT dysfunction was evidenced. Although~     previous animal studies showed that the dysfunction of brain OXT systems might be implicated~     in startle reflex and in its modulation, no study has been performed yet in human that~     investigated the influence of OXT administration on the startle response and on its affective~     modulation. A first aim of this study is to investigate the influence of OXT on stress~     reactivity and emotional modulation in healthy humans. A second aim is to develop a method~     for the investigation of anxiety disorders. Fifty male healthy participants will be tested~     using a randomized double-blind placebo-controlled cross-over design in two occasions; once~     with administration of 24 IU OXT, and once with placebo using nasal sprays while performing a~     computer-based experiment, in which emotional pictures and auditory startle probes are~     presented. We will measure the subject's subjective ratings of the pictures as well as the~     facial EMG activation, heart rate and electrodermal activation throughout the study. This~     project offers a unique opportunity to study the relationship between the OXT system and~     basic motivational and emotional behaviors. The investigation of these mechanisms is in turn~     greatly worthwhile, not only for understanding of the neurochemical and physiological~     processes involved in emotional regulation, but also for the comprehension of the~     neuroendocrine and neurophysiological mechanismsunderlying anxiety disorders. In the long~     term, it could open the possibilities of OXT as a psychobiological therapeutics of~     psychiatric disorders.~   "
190851|NCT01066286|"~     Core binding factor (CBF) positive acute myeloid leukemia (AML) consist of 15% of patients in~     overall AML, expected to harbor a favorable prognosis. However, around a half of cases~     relapses. Accordingly, more sophisticated classification in CBF positive AMLs is essential to~     achieve further improvement in the treatment outcome. The current study is designed to~     evaluate CBF positive AML patients with genome-wide SNP array and KIT mutation study in CBF~     positive AML patients diagnosed at the Samsung Medical Center and Hwasun Chonnam National~     University Hospital, Korea between 1994 and 2008.~        1. Construction of the CBF positive AML patient cohort: clinical database establishment~          (including treatment outcomes and prognosis) and extraction/storage of tumor cell DNAs~          from marrow samples, then processing of Affymetrix SNP array 6.0.~        2. Construction of prognostic predictive model using pharmacogenomics with the results of~          genotypes and copy number variations (CNVs).~        3. Detection of hidden microscopic cytogenetic lesions with SNP array technique, and~          correlation with clinical outcomes in CBF positive AML.~        4. Detection of KIT, FLT3/ITD, and NPM1 gene mutation and its correlation with clinical~          outcomes in CBF positive AML.~      The current study attempts to analyze genetic data of core binding factor (CBF) positive~     acute myeloid leukemia (AML) using genome wide SNP array technique with tumor DNAs collected~     at the time of diagnosis.~        1. To detect microcytogenetic lesions and will analyze its prognostic significance~        2. To analyze genome-wide genotypes and copy number variations (CNVs) using pharmacogenetic~          approach and will construct a prognostic predictive model~        3. To detect KIT, FLT3/ITD and NPM1 mutation and evaluate its prognostic significance. The~          present study will establish individualized therapy for CBF positive AML, will provide a~          basis for molecular marker guided clinical trial in CBF positive AML.~   "
190868|NCT01066065|"~     The advent of new antiretroviral drugs improved the management of HIV naive patients in terms~     of efficacy. However, the long term metabolic profile of this drugs has not yet been compared~     and associations between new antiretrovirals and cardiovascular events remains controversial.~      Moreover, the better tolerability and easy dosage of this new drugs might hypothetically~     influence adherence and QOL of HIV patients.~   "
190869|NCT01066052|"~     This study was conducted to evaluate the efficacy and safety of recombinant human growth~     hormone (r-hGH) treatment in young girls with Turner Syndrome.~   "
191145|NCT01062438|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with~     localized or metastatic osteosarcoma.~   "
190852|NCT01066273|"~     Studies have established that the somatosensory system of the upper cervical region and head~     can be intimately involved in tinnitus. Tinnitus can arise directly from a disorder of the~     head and upper neck via the somatosensory system. Our clinical experience and review of~     reports of various types of treatments support the hypothesis that treatment modalities~     involving the somatosensory system can benefit individuals whose tinnitus is likely on a~     somatosensory basis, namely people with symmetric hearing thresholds but asymmetric widely~     fluctuating tinnitus. However these previous studies did not (a) limit their treatment~     population to only people with tinnitus on a somatosensory basis and (b) did not assess their~     results by considering this tinnitus subpopulation separately from the entire group of~     tinnitus subjects they treated. Hence, the purpose of this study is to re-assess these~     treatments by targeting people whose audiograms can not account for their tinnitus, such as~     individuals with symmetric hearing thresholds but asymmetric widely fluctuating tinnitus~   "
190853|NCT01066260|"~     Probiotic administration is associated with health benefits on gut barrier integrity and~     immunological functions of the gastrointestinal tract. Recently, probiotic consumption was~     proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al.~     2009). Changes in energy metabolism might be involved in the effects of probiotics on weight~     control.~      The objective of this study was to assess the efficacy of the consumption of a probiotic~     formulation on energy balance in overweight subjects.~   "
190854|NCT01066247|"~     Blood pressure drop following spinal anesthesia is connected with sympathetic/parasympathetic~     activity which may be determinated by Heart Rate Variability (HRV) assessment. Sympathetic~     predomination expressed as LF/HF ratio above 2.5 is strongly connected with deeper blood~     pressure fall. As drugs given for premedication may have impact on HRV variables, the~     investigators would like to determine if pharmacological premedication may modify hemodynamic~     changes following spinal blockade. Two drugs will be compared - midazolam which is known to~     lead to increase in LF/HF ratio and morphine - opioid which provokes opposite effect.~   "
190855|NCT01066234|"~     This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely~     resected microscopic N2 NSCLC~   "
190856|NCT01066221|"~     The purpose of this study is to establish which of the following tests perform best in~     diagnosing clostridium difficile. PCR, Enzyme Immunoassays (EIA) and C. difficile cytotoxin~     assay (CTA).~   "
190857|NCT01066208|"~     Vasculitis is group of diseases where inflammation of blood vessels is the common feature.~     Patients typically present with fever, fatigue, weakness and muscle and joint aches. These~     symptoms are very common among many different diseases, not just vasculitis. A clustering of~     other symptoms, physical examination findings, blood tests, radiology and biopsy help make~     the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis~     when a patient presents with these non specific symptoms and they are reliant on previous~     experience and disease definitions. One of the aims of this project is to develop diagnostic~     criteria for the primary systemic vasculitides (granulomatosis with polyangiitis (Wegener's),~     microscopic polyangiitis, Churg Strauss syndrome, polyarteritis nodosa, giant cell arteritis,~     Takayasu arteritis). We, the investigators, will do this by studying a large group of~     patients with vasculitis and comparing them to a large group of patients that present in a~     similar way, but do not have vasculitis. By comparing the 2 groups we will create a list of~     items to differentiate between vasculitis and 'vasculitis mimics'.~      We also aim to update the current classification criteria. Classification criteria are used~     to group patients into different types of vasculitis, once a diagnosis of vasculitis has been~     made, and are useful for studying patients in clinical trials with similar or identical~     diseases. The current classification criteria (American college of Rheumatology 1990~     criteria) were developed 20 years ago, before the availability of some important diagnostic~     tests (e.g. antineutrophil cytoplasmic antibodies [ANCA]), and are now not consistent with~     some of the current disease definitions. Therefore to progress future research in vasculitis,~     it is important that the classification criteria are updated. We will recruit 260 patients~     with each of the 6 types of vasculitis and compare them with 1300 controls (patients with the~     5 other types of vasculitis), in order to determine the optimal combination of symptoms,~     signs and investigations that classify each person into the appropriate group.~   "
190858|NCT01066195|"~     Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to~     be more effective to non-small cell lung cancer (NSCLC) patients with clinical~     characteristics such as adenocarcinoma, never smoker and female.~      The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to~     NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history~     as second- or further-line therapy.~   "
190859|NCT01066182|"~     The purpose of this study is to determine whether DHA (in a daily dose of 600 mg.) will~     improve the behaviour and learning of normal children aged 7-9 years in mainstream state~     schools who are underperforming according to nationally standardized tests.~   "
190860|NCT01066169|"~     As recommended by the Dutch Health Council, certain risk groups and health care workers in~     The Netherlands were vaccinated to prevent morbidity due to pandemic influenza A/H1N1. Adults~     were vaccinated twice with the monovalent influenza A/California/2009(H1N1) MF59-adjuvanted~     surface-antigen vaccine Focetria® (Novartis). The vaccination campaign was executed by~     general practitioners.~      The aim of the study is to verify whether HIV-infected individuals generate an adequate~     immune response after the first and after the second vaccination.~   "
190861|NCT01066156|"~     This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in~     PTSD.~   "
190862|NCT01066143|"~     The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be~     combined with fMRI experiments.~   "
190863|NCT01066130|"~     The aim of this study is to evaluate the results of psychosocial treatment in patients with~     newly diagnosed rheumatoid arthritis and/or diabetes.~   "
190864|NCT01066117|"~     The purpose of the proposed study is to test the effect of the new gel pad on the quality of~     life of urinary incontinent men and women and to assess to what extent the gel pad improves~     the quality of life of incontinence persons.~   "
190865|NCT01066104|"~     The investigators are doing this research study to learn more about a drug called Xolair~     (omalizumab). The investigators want to see if it is an effective treatment for chronic~     rhinosinusitis (CRS). Specifically, the investigators want to see whether Xolair will make~     nasal polyps smaller and less thick, and relieve symptoms in people with CRS. Polyps are~     abnormal growths of tissue that can grow in the lining of your sinuses (the inside of your~     nose). The investigators also want to find out if it is safe to use (whether it causes side~     effects).~   "
190870|NCT01066039|"~     This is a 24-week, prospective, multicenter, open-label, single-arm study to assess the~     effect of bisoprolol on glycemic level in Type 2 diabetes mellitus (T2DM) controlled subjects~     with hypertension. The hypothesis of study is that there is no change in glycemic level and~     lipid metabolism as determined by glycosylated hemoglobin (HbA1c) using bisoprolol in T2DM~     subjects with suboptimal blood pressure (BP) control.~   "
190873|NCT01066000|"~     This open-label single-arm study will evaluate the efficacy, safety and tolerability of~     methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in~     patients with chronic renal anaemia. Patients will receive methoxy polyethylene~     glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or~     200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose~     adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24~     weeks. The target sample size is 50-100 patients.~   "
190874|NCT01065987|"~     The purpose of this bioequivalence study is to compare the test tizanidine Hydrochloride 4mg~     tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in~     healthy adult subjects under fed conditions.~   "
190875|NCT01065974|"~     The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal~     Replacements (MR) and a condition focusing on the nutritional changes to the home food~     environment (HFE) on weight loss, weight loss maintenance, nutritional composition of the~     diet and psychosocial outcomes. A second aim is to determine the degree to which the specific~     targets of the experimental interventions do in fact change in the anticipated direction~     during the intervention and to evaluate whether such changes might account for improvements~     in weight loss maintenance. This study is important because it could provide the first~     evidence that the current standard of care for obesity lifestyle treatment could be improved~     by the addition of MRs or a program of comprehensive nutritional change.~   "
190876|NCT01065961|"~     Anterior cervical discectomy and fusion with or without decompression is a well-established~     surgical treatment for spine patients with the appropriate indications. Anterior approach~     involves some retraction that affect the midline structures of the anterior neck. Irritation~     and swelling may result, leading to postoperative dysphagia and the less common but~     critically important occurrence of postoperative airway compromise. Steroids given~     intraoperatively may reduce the incidence of these adverse outcomes by reducing the degree of~     swelling within the anterior neck subsequent to local surgical tissue trauma.~      The investigators hypothesize that the use of steroids intraoperatively provides a~     significant benefit to the patient, in terms of reduced incidence of dysphagia and airway~     compromise.~   "
190877|NCT01065948|"~     The goal of this clinical research study is to learn about a new minimally invasive glucose~     monitoring device called Fluorescence Affinity Sensor (FAS). In this study, the FAS will be~     used to determine its effectiveness for glucose monitoring. Researchers want to find out how~     the device performs at two different body sites (forearm and abdomen) over 4 hours. The~     safety and comfort level of the device will also be studied.~   "
190878|NCT01065935|"~     To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung~     transplant patients~   "
190879|NCT01065909|"~     Primary objective shared by the 3 registries : Describe the different pharmacotherapeutic~     management in patients :~        -  DB (Diabetes): with type 2 diabetes, treated with oral and / or injectable antidiabetics~        -  CP (Chronic Pain): with any disease leading to chronic pain (lasting for more than 3~          months)~        -  AF (Atrial Fibrillation): with ongoing AF or AF diagnosed within 12 months before~          enrollment~      Secondary objectives shared by the 3 observatories:~        -  Describe the occurrence of clinical events, hospitalizations and death, according to the~          different medical care conditions, and analyze their predicting factors~        -  Estimate the resources consumption according to the medical and non medical management~          of these patients,~        -  Analyze the impact of some factors (patient's cognitive status, autonomy, renal function~          ...) on the current practice~      Secondary objectives specific shared by DB and AF registries :~      - Analyze the geriatric pharmaco-genetic aspects~      Specific secondary objectives for each observatory :~        -  DB : Describe HbA1c level, percentage of responders and body weight evolution according~          to the different medical care conditions~        -  CP : Evaluate pain consequences on Daily Living Activities and patient autonomy~   "
190880|NCT01065896|"~     Although conventional risk factors for coronary heart disease (CHD) have been identified and~     routinely used to determine risk for CHD in the general population, a systematic approach to~     determine population-specific risk for CHD has not been performed prospectively in those with~     SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in~     the able-bodied population. Conventional risk factors for CHD are high serum concentrations~     of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL),~     diabetes mellitus (DM), positive smoking history, and positive family history of premature~     CHD.~      Coronary calcification (CAC) is a commonly occurring phenomenon that does not necessarily~     indicate significant obstructive disease. Studies have shown that a strong association exists~     between coronary calcification and coronary heart disease. The purpose of this study is to~     compare the CAC scores in persons with SCI with a historical control group of able-bodied~     persons from a national data base who will be matched for conventional risk factors for~     coronary artery disease (CAD) and to determine the relationship between CAC scores and~     conventional and emerging risk factors for CAD.~   "
190881|NCT01065883|"~     This study compares an asthma self-management intervention, delivered to the family and~     tailored to their needs and cultural beliefs, to standard asthma education on two risk~     factors for asthma exacerbations in high-risk Puerto Rican children in high school. The~     self-management intervention will be a series of home visits provided by Puerto Rican~     community health workers. During home visits, the family will be educated using a standard~     asthma Core Curriculum which is tailored to individual needs, strengths, and beliefs.~     Specific Aim 1 is to test the ability of this tailored community health worker~     self-management intervention to reduce home asthma triggers and increase medication adherence~     in Puerto Rican adolescents with asthma. Specific Aim 2 is to test if any changes in triggers~     and adherence associated with this intervention are sustained 8 months after the completion~     of the active intervention. Another goal of the study is to build community capacity for~     asthma management in the target high-risk community.~   "
190894|NCT01065714|"~     While the repair of the epidermal barrier in atopic dermatitis is of major importance in the~     treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of~     an impaired epidermal barrier. Hydrogel vehicle is anecdotally known to be moisturizing and~     hydrating.This study will compare the use of Hydrogel vehicle and Eucerin Lotion in~     maintaining the epidermal barrier in subjects with atopic dermatitis.~   "
190882|NCT01065870|"~     This study is for patients with locally advanced pancreatic cancer (cancer that involves the~     local blood vessels so it cannot be removed without cutting major blood vessels) that cannot~     be treated with surgery. The purpose of this study is to assess the safety and benefit of 6~     three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and~     docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only~     venous involvement. Group II patients have arterial involvement and may also have venous~     involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of~     radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation~     treatment, participants may be able to have surgery to remove any remaining pancreatic~     cancer.~   "
190883|NCT01065857|"~     The purpose of this study is to determine any significant differences in the efficacy and~     acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of~     gastrointestinal subjects undergoing a colon examination.~   "
190884|NCT01065844|"~     The purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an~     oncologic agent for adenoid cystic cancers of the head and neck.~      Specifically, subjects will be asked to take 1250 mg twice daily and follow-up with their~     medical oncologist as clinically indicated while taking this medication.~      Subjects would be evaluated for quality of life issues utilizing the EORTC QLQ-C30 2-page~     questionnaire.~      Subjects would also be evaluated clinically by the oncologist to determine if the NFV was~     having an anti-neoplastic effect.~      The study remains unfunded. Therefore, potential subjects must be willing to provide~     self-travel to study site. This study requires a screening visit, initial study visit, and~     monthly follow-up. Subjects are not reimbursed for time, travel, or physician costs.~   "
190885|NCT01065831|"~     The purpose of this study is to test the effect of a church-based lifestyle intervention on~     blood pressure reduction in 400 hypertensive blacks (BP> 140/90 mm hg).~   "
190886|NCT01065818|"~     The goal of this research study is to learn if a new type of PET scan (18F-FLT) can help to~     better detect changes of tumor growth rate (or how active) in esophagus cancer and lung~     cancer Researchers will study at what time during treatment the 18F-FLT PET scan should be~     given to get the best results. A Positron Emission Tomography (PET) scan is a type of scan~     that uses a radioactive solution to locate cancer cells inside the body. Using the PET scan,~     doctors can locate solid tumors and collect information about how active the cancer cells~     are. For this study, a new type of solution, [F-18]-ﬂuoro-L-thymidine (FLT), will be used.~     FLT can detect actively growing tumor, and researchers hope that FLT may be able to help~     provide information about how well esophagus cancer treatment is working. This information~     could be used to help predict if the cancer will respond to treatment.~      All enrolled subjects will receive PET/CT imaging at pre-Neoadjuvant Therapy and post-3 weeks~     Neoadjuvant Therapy (3 weeks from the start of Neoadjuvant Therapy) prior to the surgery. At~     each time of the PET/CT procedure, the subject will receive an injection of FLT which is an~     investigational pharmaceutical labeled with radioactive ﬂuorine. 45-60 mines after the FLT~     injection, the scan will be performed. Each scan might take 10-15 minutes. Participation in~     this pilot study will not change the patients normal chemotherapy, radiation treatment, and~     surgery recommended the patients physician as parts of their standard of care.~   "
190887|NCT01065805|"~     The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images.~     Tumour growth rate is a useful indicator of tumour aggression and response to treatment.~     Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to~     anticancer treatment.~   "
190888|NCT01065792|"~     This survey is conducted for preparing application materials for re-examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the~     clinical usefulness of STOCRIN through collecting the safety and efficacy information~     according to the Re-examination Regulation for New Drugs.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
190889|NCT01065779|"~     This survey is conducted for preparing application materials for re-examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the~     clinical usefulness of FOSAMAX PLUS / FOSAMAX PLUS D through collecting the safety~     information according to the Re-examination Regulation for New Drugs.~      Note: FOSAMAX PLUS D is known as FOSAMAX PLUS in several markets. FOSAMAX PLUS (70 mg/2800~     IU) and FOSAMAX PLUS D (70 mg/5600 IU).~   "
190890|NCT01065766|"~     This survey is conducted for preparing application materials for re-examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the~     clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and~     efficacy information according to the Re-examination Regulation for New Drugs.~   "
190891|NCT01065753|"~     Central obesity, core of metabolic syndrome, has been recognized as one of the rooting~     factors for development of diabetes and cardiovascular disease. Although efforts have been~     devoted to the studies of central obesity and/or metabolic syndrome, much remained unknown as~     to how obesity influences cellular as well as cardiac functions, what is the central~     regulation of one's body weight.~      Weight loss is an undisputed way to improve cardiovascular and metabolic disorders in obese~     individuals. Previous studies have demonstrated that weight loss by 5% of initial weight~     universally provide substantial benefits in these subjects. However, there are little~     integrated research teams, composed of different disciplines, share common weight reduction~     program to look at different aspects of weight reduction in non-diabetic individuals with~     metabolic syndrome. The significances of this proposal we plan to target, namely Rho kinase~     activity from peripheral leukocyte, several cardiac functions measured by noninvasive~     technique (VP-2000) and MRI, circulating brain-derived neurotrophic factors (BDNF) levels,~     are fully explained detailed in each sub-proposal.~      In order to accomplish this integrated proposal, we will form research teams including~     endocrinologists, cardiologists, radiologists, and a coordinating data center. We pan to~     recruit 40 non-diabetic individuals with metabolic syndrome to participate this 12-16 weeks~     weight reduction program. Twenty-five age, sex matched non-diabetes lean will be served as~     controls. Oral glucose tolerance test, fasting blood obtained, noninvasive vascular and MRI~     examinations will be applied before and after weight reduction program in those achieving at~     least 5% loss of initial weight.~      In summary, this study will investigate the effects of weight loss on (1) Rho kinase activity~     obtained from peripheral leukocyte; (2). Aortic stiffness, central aortic pressure and~     hemodynamic by a noninvasive vascular profiling system (VP-2000); (3) Brain function~     specifically reflecting by circulating BDNF; (4). Aortic elastic properties and left~     ventricular function by using MRI examinations, in non-diabetic individuals of metabolic~     syndrome.~   "
190892|NCT01065740|"~     Peripheral arterial disease (PAD) is a frequent and serious chronic disease witch is~     undertreated. The recommended management of PAD include pharmacological approach and~     lifestyle modifications. Patient education help to reach this outcome. Our study propose to~     compare patient education management with physical activity coaching to usual care.~   "
190895|NCT01065701|"~     Intranasal dexmedetomidine has shown to be an effective sedative when used prior to~     anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in~     previous study and it produced satisfactory sedation in more than 50% of the children at the~     time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg~     with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain~     satisfactory sedation prior to anaesthetic induction when higher dose is used.~   "
190896|NCT01065688|"~     The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I~     reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction~     (R-Y) in patients with gastric cancer.~   "
190897|NCT01065675|"~     Up to 50% of medication errors and 20% of adverse drug reactions (ADRs) in the hospital~     setting are estimated to be related to communication issues regarding patient medications at~     various transition points of care from admission to discharge. The Joint Commission (TJC)~     requires accurate and complete medication reconciliation occur at each transition point~     throughout hospitalization. Evidence from NQF demonstrates pharmacists (RPh) are the most~     effective medication management team leaders in the implementation of medication management~     practices and design of medication error reduction strategies; medication reconciliation is~     one of the five safety objectives pharmacists are recommended to lead. In addition, the~     Massachusetts Coalition for the Prevention of Medical Errors states strong evidence supports~     the use of pharmacy technicians (CPhT) in conjunction with pharmacists in completing accurate~     medication histories.~      WMC nurses (RN) currently are involved in the medication reconciliation process. In 2009, a~     Medication Use Evaluation (MUE) of Medication Reconciliation Accuracy found a 67% medication~     error rate on admission determined by comparing the nurse-obtained medication history to the~     pharmacist-obtained medication history. The number of home medications identified by the~     pharmacist compared to the nurse was 411 versus 312 (p<0.0001). The total percentage of~     medication errors prevented by the pharmacist was 66.2. Using the VA Healthcare Failure Mode~     Effects Analysis - HFMEA™ Hazard Scoring Matrix, 3 independent pharmacist reviewers found~     that 18% of patients interviewed had a score greater than 7, and 3 patients had a score of 12~     (major/probable), if the discrepancies would not have been identified and corrected by the~     pharmacist conducting the admission medication reconciliation audit. The same patients'~     discharge medication reconciliation and discharge medication lists were retrospectively~     reviewed for the MUE, and the total percentage of patients with medication errors on~     discharge was 43%.~   "
190898|NCT01065662|"~     The purpose of this research study is to determine the safety of the combination of the two~     drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given~     in combination to people safely. Cediranib is a drug that may stop blood supply to the tumor~     and therefore help keep cancer cells from growing. Temsirolimus is a drug that may stop~     cancer cells from growing. These drugs have been used in other research studies in ovarian~     and kidney cancer and these studies suggest that these drugs may help to keep cancer from~     growing in this research study.~   "
190899|NCT01065649|"~     Patients with nonerosive reflux disease (NERD) are less responsive to standard treatment with~     proton pump inhibitors. The hypothesis of this study was that nortriptyline in analgesic~     doses may decrease heartburn perception and its corresponding cortical activity measured by~     magnetic resonance image. Therefore, the aim of this study was to assess the cortical~     representation of heartburn in patients with NERD under treatment with nortriptyline and~     placebo.~   "
190900|NCT01065636|"~     Obesity causes frailty in obese older adults by exacerbating the age-related decline in~     physical function. However, appropriate management of obesity in older adults is~     controversial. Weight loss without exercise could worsen frailty by accelerating the usual~     age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia,~     respectively. Because of the important problem of frailty in obese older adults, it is~     important to determine the most efficacious approach in reducing, or even reversing frailty~     in this population. The primary objective of this proposal is to evaluate which distinct type~     of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most~     efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and~     reversing frailty in obese older adults.~   "
190901|NCT01065623|"~     Clinical study to determine safety, tolerability, to measure how the drug is metabolized by~     the body and to determine the maximum tolerated dose of BAY79-4620 given every 2 weeks to~     patients with advanced solid tumors~   "
190902|NCT01065610|"~     This study investigated, if people with impaired coping abilities benefit from intranasal~     oxytocin application.~   "
190903|NCT01065597|"~     This study involves pilot testing of a modified version of a proven treatment for mental~     illness. The treatment, electroconvulsive therapy (ECT) is used to treat more than 100,000~     Americans yearly. ECT is the most effective treatment for major depression, a disorder that~     affects approximately 5 to 8 percent of the adult US population yearly. It is also an~     effective treatment for mania and mixed mood states associated with bipolar disorder and~     schizoaffective disorder.~      The aim of ECT is to induce a seizure, which is thought to be responsible for both its~     therapeutic and its adverse cognitive effects. The proposed modification consists of reducing~     the ECT electrical stimulus dose below the amount necessary to induce seizures so that~     adverse cognitive effects, such as confusion and memory problems, are minimized.~      The investigators intend to determine whether ECT-related cognitive impairment can be reduced~     without diminishing the therapeutic effect of ECT. In addition to distressing patients,~     ECT-related cognitive impairment has significant public health consequences. These include~     increased morbidity and mortality among severely ill individuals who refuse ECT due to~     concern over its adverse cognitive effects as well as increased falls among the elderly~     receiving ECT. Elderly patients are far more likely to receive ECT and are also more~     vulnerable to ECT-related cognitive impairment. They often require hospitalization for ECT~     and a longer hospital stay with greater spacing of treatments to minimize adverse cognitive~     effects.~      The hypothesis driving this research is that electrical brain stimulation applied in the same~     manner as standard ECT, but at a lower dose, can have therapeutic effects and fewer adverse~     cognitive effects without inducing seizures. This hypothesis is based on the following: 1)~     the investigators clinical experience of patients who have improved with ECT despite having~     only one or no seizure, 2) animal studies showing that electrical brain stimulation can~     induce antidepressant like effects in animals without inducing seizures, 3) reports from the~     1950s that subconvulsive and nonconvulsive electrotherapy was effective for some~     patients, and 4) the recent approval by the US Food and Drug Administration of the use of~     transcranial magnetic stimulation --a technique that uses a magnet to induce an electrical~     current in the brain without inducing seizures--for treatment of medication resistant major~     depression.~      The primary aim of the research is to conduct a proof of concept, open trial investigating~     the therapeutic efficacy and safety of nonconvulsive electrotherapy (NET). The investigators~     plan to enroll 16 subjects, which is the minimum number of subjects needed to show that the~     therapeutic effect of NET is better than would be expected of placebo. If the investigators~     show that the therapeutic effect of NET exceeds that expected of placebo and does not induce~     significant cognitive impairment, then the investigators will go on to propose a blind,~     randomized, controlled clinical trial that more definitively tests the investigators'~     hypothesis. The investigators would use the information gathered from the pilot trial to~     estimate the number of subjects needed to definitively test the efficacy and safety of NET.~      The secondary aim of the study is to find out whether NET affects blood levels of~     brain-derived neurotrophic factor (BDNF). BDNF is a substance that is important to the~     nervous system and may be related to how treatments like ECT or possibly NET improve~     symptoms. The investigators would draw a blood sample before and after NET treatment to~     assess this.~   "
190904|NCT01065584|"~     In experimental and clinical settings it has been shown that transplant tolerance is~     possible. It has been suggested that regulatory T cells play a beneficial role in the~     establishment of tolerance. Calcineurin inhibitors may inhibit development of regulatory T~     cells. However, the influence of calcineurin inhibitors on markers of transplant tolerance~     has not been studied in patients undergoing liver transplantation. Currently the~     investigators conduct a study to evaluate the safety and efficacy of a calcineurin inhibitor~     free immunosuppression in patients undergoing liver transplantation. In this study~     measurements of immune function and CD4+CD25high-Foxp3+-Il2/CD8+ status will also be~     performed. In parallel these measurements should be compared to a group of patients~     undergoing standard immunosuppression including calcineurin inhibitors.~   "
190905|NCT01065571|"~     The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free~     interval in patients with ulcerative colitis.~   "
190906|NCT01065558|"~     The purpose of this study is to determine the effects of ecopipam in patients with~     Lesch-Nyhan Disease (LND). Ecopipam specifically blocks the actions of one chemical in the~     brain that helps nerves talk to one another; ecopipam does this by stopping the chemical~     (dopamine) from binding to one of its family of receptors (i.e, the D1 family). LND is a very~     rare genetic disease. The sponsor is doing this study to find out what side effects ecopipam~     causes in LND patients, and whether ecopipam may be able to relieve the self-injurious~     behaviors seen in these patients.~   "
190907|NCT01065545|"~     The purpose of this study is to determine the side effects of the study drug, clofarabine,~     when given by mouth to patients with acute myeloid leukemia (AML), in remission.~   "
190908|NCT01065532|"~     Different healing responses after treatment of bare metal stent restenosis with implantation~     of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting~     SeQuent Please balloon (BBraun): an optical coherence tomography study.~      A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT~     follow-up at 9 months.~   "
190909|NCT01065519|"~     Assessment of vessel healing after DES implantation in STEMI, NSTEMI and stable/unstable~     angina patients: a randomized comparison between everolimus and biolimus A9-eluting stents:~     an optical coherence tomography (OCT) and intravascular ultrasound-tissue characterisation~     (IVUS-TC) study.~      Plaque characterisation substudy: Assessment of culprit lesions in different subsets of~     patients (STEMI, NSTEMI and stable/unstable angina) by use of optical coherence tomography~     (OCT) and intravascular ultrasound tissue characterisation (IVUS-TC).~   "
190910|NCT01065506|"~     The primary aim of this research study (STEP) is to compare the effectiveness of two smoking~     cessation programs that integrate counseling and nicotine replacement with either a wellness~     program or exercise. This will help us to determine whether different lifestyle interventions~     (wellness or exercise) help increase the effectiveness of current standard programs for~     smoking cessation.~   "
190911|NCT01065493|"~     QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase~     II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care,~     patient-centered resource for counseling patients who smoke or use tobacco products. It is~     based on the principles of Motivational Interviewing, a non-confrontational and very~     effective method for intervening and treating these patients; the 5 A's of behavioral~     interventions; and the Transtheoretical Model of Change. Through a point and click interface,~     the tool uses a series of interview questions designed to motivate patients to stop smoking~     by first assessing their stage of change and then offering effective stage-based~     interventions and interview techniques. The tool also offers stage-tailored patient~     information, a clinician educational reference, and the ability to communicate support~     information patients via email and/or text message.~   "
190912|NCT01065480|"~     This study aims to train Substance Abuse Treatment Clinicians in the use of Motivational~     Interviewing techniques through live supervision.~   "
190913|NCT01065467|"~     The purpose of this research study is to determine the safety of LBH589 as well as to find~     out what side effects it may cause and how effective it is against melanoma. LBH589 is a drug~     which may slow down the growth of cancer cells or kill cancer cells by blocking certain~     enzymes, which are proteins normally produced by cells. These enzymes are known to play an~     important role in the development and reproduction of cancer cells. It is believed that~     LBH589 works by helping to promote the activity of enzymes which turn on the mechanisms in~     our cells that suppress cells from becoming cancerous.~   "
190914|NCT01065454|"~     The aim of this study is to assess whether increasing oral doses of Riociguat are safe and~     improve the well-being, symptoms and outcome in patients with pulmonary hypertension~     associated with left ventricular systolic dysfunction~   "
190915|NCT01065441|"~     A Phase I/II study of an in-situ therapeutic cancer vaccine. Vaccines contain a source of~     antigen and and adjuvant. In this study the source of tumor antigen comes from the killing of~     a selected tumor by cryoablation (killing using extreme cold) and the adjuvant is~     intentionally mis-matched immune cells (AlloStim-TM) engineered to produce inflammatory~     cytokines.~   "
190916|NCT01065428|"~     The aim of this study was to compare the indices of rapid shallow breathing, neuromechanical~     efficiency (NME), and neuroventilatory efficiency (NVE) between patients being successfully~     extubated and those who failed weaning.~   "
190917|NCT01065415|"~     The accurate staging is an essential part for the treatment and prognosis of non-small-cell~     lung cancer (NSCLC). Whole body MR imaging proved to be effective in staging of NSCLC as much~     as PET/CT. And there were organs of strength for each modality in the detection of~     metastasis. Therefore, integrated approach using whole body MR and PET would be more~     beneficial for the accurate staging of lung cancer with improved diagnostic efficacies and~     reduced radiation exposure.~      The aim of this project is to evaluate the diagnostic efficacy of side-by-side reading of~     whole-body magnetic resonance imaging/ positron emission tomography (MRI/PET) and to compare~     with that of whole-body magnetic resonance imaging (WB MRI) alone and that of integrated~     PET/CT in determining the stage of NSCLC.~      Patients with pathologically-proven NSCLC will be prospectively enrolled, if they are~     considered as surgical candidates for the treatment of lung cancer through conventional~     methods of staging, i.e. history taking, physical examination, blood tests, bronchoscopy, and~     enhanced chest CT scans. PET/CT will be routinely performed for the staging of lung cancer in~     our institution. For the purpose of this study, whole body MRI will be performed for these~     patients within 3 days from the date of acquisition of PET/CT. The results of TNM staging~     from each modality will be collected prospectively and their efficacies can be calculated~     based on the reference standards. Reference standards of T and N staging will be surgically~     confirmed. And M staging can be confirmed by biopsy, other imaging modalities, or follow-up~     more than 6 months.~      Diagnostic efficacies of coregistered MRI/PET can be evaluated with the comparison from the~     consecutive two-arm enrollment with random assignment of control group and study group as~     follows:~        -  control group: routine staging work-up with chest CT, PET/CT, and brain MRI~        -  study group: routine staging work-up plus whole body MRI for Coregistered MRI/PET~   "
190918|NCT01065402|"~     To evaluate the efficacy of PPB-R-203-Based Meal and TK9-Based Meal on blood glucose control~     in 20 patients with diabetes for 2 days.~   "
190919|NCT01065389|"~     Dialysis patients usually have peripheral muscle weakness due to metabolic disturbances~     (increased protein catabolism) and fatigue. This muscle weakness may decrease functional~     capacity and quality of life. It also serves to increase cardiovascular risk factors in these~     end stage renal disease patients. Peripheral muscle strength training shall combat physical~     inactivity during dialysis. In the investigators trial, the investigators hypothesis that~     peripheral muscle training might regulate protein catabolic rate,renal functions,~     cardiovascular risk factors, improve functional capacity and quality of life in endstage~     renal disease patients undergoing dialysis.~   "
190920|NCT01065376|"~     The dopamine agonist cabergoline inhibits phosphorylation of the vascular endothelial growth~     factor receptor-2(VEGFR-2), which prevent vascular endothelial growth factor (VEGF)~     overexpression and reduce the severity of Ovarian hyperstimulation syndrome. However, VEGF~     plays an important role in the growth and maintenance of ovarian follicle and developing~     embryo by mediating angiogenesis.This study was designed to analyze whether the timing~     cabergoline administration on the day of human chorionic gonadotropin (hCG) injection or~     after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction~     treatment.~   "
190921|NCT01065363|"~     The investigators propose a project of preventive medicine with concern of local context in~     Taiwan. The target population includes all staff and faculty members, students, and alumni of~     a university in Northern Taiwan, with chronic hepatitis B infection. The intervention of this~     project includes standardized lectures, sports courses, nutrition courses, and an information~     platform. The investigators will evaluate the efficacy after the intervention, like the~     reduction of hepatitis B viral load and the associated anthropometric parameters. The results~     of this project will be initially served as a pilot study for this cohort, and applicated as~     a promising basis for health promotion.~   "
190937|NCT01065155|"~     Diabetic patients show an increased prevalence of non dipping arterial pressure pattern,~     target organ damage and elevated arterial stiffness. These alterations are associated with~     increased cardiovascular risk.~      The objectives of this study are the following: to evaluate the prognostic value of central~     arterial pressure and pulse wave velocity in relation to the incidence and outcome of target~     organ damage and the appearance of cardiovascular episodes (cardiovascular mortality,~     myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus.~   "
190922|NCT01065350|"~     This is a pilot study to compare the hemodynamic changes that occur during induction with a~     novel drug combination known as ketofol (propofol and ketamine admixture with that of~     propofol alone (prototypic anesthesia induction agent). Propofol and ketamine are widely used~     as induction agents and their effects on patient hemodynamics are well known. Some of these~     drug-induced hemodynamic changes are undesirable and lead to deleterious effects on patient~     hemodynamics. We seek to investigate the hemodynamic changes associated with a novel drug~     combination known as ketofol (ketamine/propofol admixture) during induction and compare them~     to propofol. If we determine that the changes produced by ketofol are favorable compared with~     propofol, we then will seek to test its use in the trauma setting in a subsequent randomized~     controlled trial.~   "
190923|NCT01065337|"~     Diabetic foot patients with chronic limb ischemia and without the option for surgical or~     interventional revascularization were recruited and randomized to the transplant groups or~     the control group within this clinical trial. These patients are randomized to control or~     intervention group, whereas the intervention is divided into bone marrow cells administered~     intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or~     intraarterial resulting in five distinct groups. To measure the therapeutic effects of the~     various treatment arms patients were evaluated for (ankle brachial index (ABI),~     transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level~     Dependent [BOLD]). Patients also underwent imaging with angiographic methods.~   "
190924|NCT01065324|"~     1. Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal~          diseases.~        2. Deep enteroscopy made possible by balloon expansion and manipulation of small~          intestines.~        3. However, whether intestinal barrier injured during BAE predispose patients to bacteremia~          or clinical relevant infection is not studied.~        4. We will also examine relevant patient factors.~   "
190925|NCT01065311|"~     The propose of the study is to investigate the efficacy of Mindfulness-based Cognitive~     Therapy (MBCT, Segal, Williams, & Teasdale, 2002) for patients suffering from Chronic Major~     Depression. The efficacy of MBCT will be compared with the Cognitive Behavioral Analysis~     System of Psychotherapy (McCullough, 2003), a treatment approach, which has proven it's~     efficacy yet, and with a treatment-as-usual condition (standard psychiatric outpatient care).~   "
190926|NCT01065298|"~     The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus~     patients.~   "
190927|NCT01065285|"~     The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against~     influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.~   "
190928|NCT01065272|"~     The investigators hypothesized that oral Dexamethasone in addition to nebulized Salbutamol~     will improve the Bronchiolitis Clinical Severity Score,duration of treatment in the short~     stay unit,need for hospitalization and readmissions to the pediatric emergency in a subgroup~     of patients diagnosed as Bronchiolitis with either eczema and or a parental or sibling~     history of Asthma.~      Two groups randomized will be given Nebulized Ventolin plus either oral Dexamethasone or~     placebo for 5 days.~      Bronchiolitis severity score plus vital signs will be recorded regularly until patient is fit~     for discharge.~      Patients will be discharged on Ventolin inhaler and to complete the five days course of oral~     Dexamethasone Patients will be followed up for 7 days post discharge by telephone.~   "
190929|NCT01065259|"~     The objective of this study is to compare the effect of Concerta (Osmotic Release Oral System~     Extended Release Methylphenidate HCL, OROS MPH) and Strattera (Atomoxetine) on the laboratory~     and ecological executive function in children with attention deficit hyperactivity disorder.~   "
190930|NCT01065246|"~     This phase II single arm, open-label study investigate the safety of a second cycle of~     catumaxomab in patients with malignant ascites due to carcinoma, requiring their first~     therapeutic puncture after treatment in the CASIMAS study.~   "
190931|NCT01065233|"~     Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC~     could be linked with multiple functional region of genome.~      The determining of a genomic mapping of  single nucleotide polymorphisms  (SNPs) permit to~     perform some genetic link studies with pathologies without clear hereditary disposition.~      In this study, the investigators will identify predictives genetic polymorphism of HCC.~   "
190932|NCT01065220|"~     The aim of this study is to prove the influence of the sex steroid hormones estrogen,~     progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron~     emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT~     binding will be quantified before and after hormone therapy underwent by 10 male-to-female~     (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level,~     long-term administration of opsite sex steroid hormones in transsexuals provide the unique~     opportunity to investigate the influence of sex steroid hormones on the serotonergic system.~     Since the serotonin transporter serves as a primary target molecule for antidepressant~     treatment, the results of the study will be of benefit for the assessment of the clinical~     relevance of estrogen and testosterone as modulatory and neuroactive agents.~   "
190933|NCT01065207|"~     The investigators have previously described a limited group of HIV-1-infected patients, we~     called HIV controllers (HIC), who have been infected for more than 10 years, in whom viral~     replication is spontaneously controlled without any treatment. These patients are defined~     according to virological criteria: more than 90% of the quantifications of plasma viral load~     should be less than 400 RNA copies/mL. The purpose of the ANRS EP36 study was to characterize~     these patients.~   "
190934|NCT01065194|"~     The purpose of this study is to compare the effects of a pulsed application of Levosimendan~     versus placebo on the composite end-point functional capacity and quality of life.~   "
190935|NCT01065181|"~     The purpose of this study is to document the rates of youth baseball player demographics,~     incidence of arm pain, usage of different pitch types, and degree of internal rotation~     contracture in the throwing versus the non-throwing shoulder. We followed a subgroup of~     players for a year to see if a particular stretch would help reduce the internal rotation~     contracture.~   "
190936|NCT01065168|"~     The purpose of this trial is to study ovarian reserve after laparoscopic endometrioma~     cystectomy by measuring antimullerian hormone. The measurements were measured before the~     surgery and one week and three months after the surgery.~   "
190938|NCT01065142|"~     Use lay language. Background: Heart failure is an increasingly frequent current pathology due~     to the population aging and the improvement of acute and chronic heart failure management.~     Heart failure patients have a poor quality of life because of their symptoms (asthenia,~     dyspnea…) and frequent hospitalizations. Heart failure is an expensive disease: 1.5 % of the~     health expenses, 85 % in hospital cost with 200 000 hospitalizations in France per year.~     Previous studies were multidisciplinary interventions and not realistic in a daily practice~     for a general practitioner. The aim of this project is to integrate therapeutic education for~     heart failure patients in a current practice. The patient becomes competent to manage his~     disease and to identify acute heart failure signs.~      Main objective: Improve therapeutic education efficiency on life quality of heart failure~     patients in general practice.~      Second objectives: Describe heart failure patient's hospitalizations.~      Methods: Cluster randomized controlled clinical trial comparing intervention and control~     groups with a follow through for 19 months for each patient. A therapeutic education program~     will be proposed to the heart failure patients in primary care. The intervention group GP~     will follow a workshop concerning the therapeutic education concepts and the intervention.~      Endpoints: Life quality evaluation (SF-36 and Minnesota scales) and number of~     hospitalizations of patients in each group.~      Population: Heart failure patients in stages I, II, and III of NYHA in primary care. Cluster~     randomized surgeries in Auvergne (France).~      Expected results: The therapeutic education allows the patients to improve their quality of~     life, to be able to detect their illness signs worsening in a early manner, and to contact~     their doctor if needed. This would limit the acute heart failure due to treatment adaptation~     or life habits.~   "
190939|NCT01065129|"~     Our main objectives are to determine the optimal dose and schedule of plerixafor + G-CSF and~     azacitidine in patients with MDS and determine the safety and tolerability of plerixafor +~     G-CSF and azacitidine.~   "
190940|NCT01065116|"~     The purpose of this study is to determine if adherence and effectiveness of AL in the~     treatment of uncomplicated malaria in children aged under five years using blister packs with~     pictorial leaflets can be at levels comparable to those with unit dosed age specific~     pre-packs.~   "
190941|NCT01065103|"~     It has been shown that if it can be accomplished within a 90 minute door to balloon time,~     opening an artery in an acute heart attack situation (ST elevation myocardial infarction or~     STEMI) is best treated with balloon angioplasty and stenting (percutaneous coronary~     intervention or PCI). In these situations, there may be narrowings other than the one causing~     the heart attack (culprit) and studies have shown that delaying treatment of other narrowings~     for follow-up procedure is better than intervening at the time of the acute MI.~   "
190942|NCT01065090|"~     The primary objective of the investigation is to determine whether the addition of exercise~     (resistance training or modified physiotherapy) improves functional capacity in Multiple~     Sclerosis (MS) participants undergoing Disease Modifying Therapy (DMT) treatment. We~     hypothesize that the Progressive Resistance Training (PRT) will improve functional capacity~     without increasing the risk of relapses in participants undergoing standard DMT treatment.~     The secondary objectives are to determine whether exercise (resistance training or~     physiotherapy) improves fatigue, mood and Quality of Life (QoL) in MS participants undergoing~     DMT treatment. Also as a secondary objective, the study aims at determining whether exercise~     (resistance training or modified physiotherapy) has an impact on Expanded Disability Status~     Scale (EDSS), time to first relapse, number of relapse free participants, and immunological~     factors. We hypothesize that the exercise (resistance training) will improve fatigue, mood~     and QoL and that an impact on immunological factors will be seen in participants even though~     they are undergoing standard DMT treatment.~   "
190943|NCT01065077|"~     A placebo controlled, double-blind and randomized study to assess different doses of a new~     drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the~     well-being of patients with acute decompensated heart failure.~   "
190944|NCT01065064|"~     The purpose of this study is to evaluate the distance, intermediate, and near vision after~     aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.~   "
190945|NCT01065051|"~     The aim of this study is to assess whether oral Riociguat affects the left ventricular~     contractility and relaxation in patients with pulmonary hypertension associated with left~     ventricular systolic dysfunction~   "
190946|NCT01065038|"~     Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was~     not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate~     non-inferiority was based on the following decision points:~      • ET is a rare disease and recruitment of large patient number (> 1600) to prove superiority~     was not considered possible.~      . It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment~     bias, which further limited the number of patients eligible for the study.~   "
190947|NCT01065025|"~     The purpose of the study is to investigate safety and tolerability of repeated ascending oral~     doses of 4SC-205 in patients with advanced and incurable solid tumors or malignant lymphomas.~   "
190948|NCT01065012|"~     Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally~     administered selective inhibitor of PDE-5 for the treatment of subjects with erectile~     dysfunction (ED).~   "
190949|NCT01064999|"~     Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal~     cancer. Pathological complete response (pCR) is an important prognostic factor for local~     control and survival. A high intensity CRT increases not only the pCR rate, but also~     toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified~     radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high~     dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose~     intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose~     induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT~     includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine~     weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a~     cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8~     weeks after CRT.~   "
190950|NCT01064986|"~     Corticosteroids are substances produced by the adrenal gland to help the body fight against~     infection or injury. Hydrocortisone is a man-made form of this substance. Endotoxin is a~     man-made substance, which causes the body to mimic sickness(fever,chills,and achiness)for a~     few hours. This study is designed to give hydrocortisone before and after Endotoxin to~     determine if this medication can prevent or relieve any of the symptoms caused by the~     Endotoxin.~   "
190989|NCT01064479|"~     The goal of this clinical research study is to learn if adding Tarcevaâ (Erlotinib, OSI-774)~     to the combination of docetaxel and cisplatin/carboplatin can help control SCCHN better than~     chemotherapy alone, in patients with SCCHN that has spread to other parts of the body or has~     come back after treatment. The safety of this drug combination will also be studied.~   "
190951|NCT01064973|"~     Study 22003, An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of~     STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)~     currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem~     behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will~     enter subjects who complete Study 22003 into a long-term, open-label study.The open-label~     extension protocol will provide necessary data on the long-term safety and tolerability of~     STX209 among subjects with ASD who receive treatment under conditions more closely reflective~     of their general medical care.~   "
190952|NCT01064960|"~     This study is to collect supplementary safety and technical effectiveness data of Philips MRI~     guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with~     symptomatic fibroids in a 3T MRI scanner. The importance of this therapy is that it offers a~     non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and~     peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat~     and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and~     monitors heat rise in the fibroid tissue. The goal of the study is to collect supplementary~     3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided~     HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of~     life, and imaging endpoints will be evaluated in all study patients.~   "
190953|NCT01064947|"~     Skin infections may complicate the treatment of atopic dermatitis.The use of topical~     ointments has become very important to avoid the use of oral antibiotics. There is little~     supporting literature regarding the use of topical antibiotics in secondarily infected atopic~     dermatitis.~      This study will investigate the safety and effectiveness of Altabax ointment use in treating~     secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus~     pyogenes.~   "
190954|NCT01064934|"~     Lipoprotein(a) [Lp(a)] is an independent risk factor for cardiovascular disease. Non-medical~     treatment measures (e.g. dietary therapy or weight loss) can hardly influence Lp(a) plasma~     concentrations. Drug therapy has only limited influence, e.g. treatment with niacin. Statins~     are usually without effect. Lipid apheresis is the only treatment known to lower elevated~     Lp(a) levels in a relevant way. In patients with pronounced elevation of Lp(a) and normal LDL~     cholesterol levels, who suffer from progressive cardiovascular disease, the treatment with~     lipid apheresis seems to be a last-resort treatment option. The current trial will evaluate~     the effectiveness of lipid apheresis on cardioavascular endpoints.~   "
190955|NCT01064921|"~     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. Giving vorinostat together with chemotherapy and radiation therapy may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when~     given together with cisplatin and radiation therapy in treating patients with stage III or~     stage IVa squamous cell cancer of the oropharynx which is either unresectable or borderline~     resectable.~   "
190956|NCT01064908|"~     The purpose of this study is to determine the effectiveness of oxygenation and~     patient-acceptability of a novel oxygen face mask in patients undergoing carotid~     endarterectomies (CEAs).~   "
190957|NCT01064895|"~     This is a prospective, observational, multi-center study with consecutive enrollment. Up to~     500 patients will be enrolled. All (consecutive) adult patients in whom one or more~     components of the Benephit Infusion System are planned to be used at participating sites are~     eligible for enrollment. The objective of this post-marketing surveillance study is to~     collect clinical usage patterns of the Benephit Infusion Systems. As a result, AngioDynamics~     will be able to (1) Better understand and quantify usage patterns including patient~     characteristics, adjunctive procedures, and infusion agents, (2) Collect user-interface~     information and overall customer satisfaction, and (3) Monitor post-marketing device~     performance and safety for ISO quality adherence.~   "
190958|NCT01064882|"~     This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or~     0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the~     upper eyelid margins in increasing eyelash prominence~   "
190959|NCT01064869|"~     Approximately 5% of adults with asthma have difficult to control disease but these account~     for up to 80% of total cost of asthma due to recurrent healthcare contact including hospital~     admission. The reasons for difficult asthma are multi-factorial, but an important element~     in many patients is non-adherence to steroid therapy. Recent qualitative analysis by the~     investigators group has identified a number of both individual and group themes, related to~     non-adherence with steroid treatment. Many of these themes such as steroid phobia, inaccurate~     / lack of knowledge, negative attitudes and inability to deal with side-effects, are~     potentially modifiable and the investigators believe, unless these issues are addressed, at~     an individual patient level, adherence is unlikely to improve. This randomised parallel group~     study will examine a nursing intervention to try and improve adherence and as a consequence,~     asthma control, in a group of difficult asthmatics where non-adherence has been identified as~     a significant factor. The study will use a needs-led menu driven individualised intervention~     and will compare this to current best asthma care. The primary outcome measure will be~     adherence to therapy, however asthma control, lung function and asthma related quality of~     life, patients' attitudes to asthma and treatment and their levels of anxiety and depression~     will also be examined. Addressing the issue of non-adherence is fundamental to improving~     asthma management in this difficult group with concomitant reduction on health care costs and~     improvements in patients' quality of life~   "
190960|NCT01064856|"~     The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg~     administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks~     followed by open label (OL) safety and efficacy assessments in participants with~     non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral~     spondyloarthritis (SpA) who have had an inadequate response to >= 2 non-steroidal~     anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for,~     NSAIDs.~   "
190961|NCT01064843|"~     Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test~     whether 4 mini-implants placed at the front of the lower jaw can stabilize an~     immediately-modified existing lower denture.~   "
190962|NCT01064830|"~     Brittle nail syndrome (BNS) refers to nails that exhibit splitting, raggedness (fraying of~     the distal edge), and peeling (lamellar onychoschizia).(1) This is a common problem,~     affecting approximately 20% of women, with higher prevalence among the elderly.(2) A number~     of factors have been proposed as possible causes of nail brittleness, such as anemia, biotin~     deficiency, or cysteine deficiency. (3,4) However, most authors believe that brittle nails~     are usually caused by dehydration of the nail plate, either from repetitive cycles of~     hydration and dehydration related to hand washing or from exposure to dehydrating chemicals,~     such as those found in nail enamel and cuticle removers. (5,6) Inflammation of the nail as a~     potential contributing factor has never been studied.~      There are currently not consistently effective treatments for this condition. Restasis® is~     effective in treating keratoconjunctivitis sicca. This condition is characterized by the~     troublesome condition of dry eyes partially due to decreased tear production exacerbated by~     inflammation. The BNS manifests itself by nail plate dehydration. The two conditions have in~     common disruption of water balance which gives rise to problematic clinical disorders. The~     hypothesis is that a product which benefits tear production would also be effective for~     brittle nails which contain roughly 15% water.~   "
190963|NCT01064817|"~     This study will assess the safety and tolerability of PRM-151 administered as a~     subconjunctival injection and explore the effect of PRM-151 on various correlates of the~     wound healing process that occurs in the eye after glaucoma filtration surgery.~   "
190964|NCT01064804|"~     To test the relative bioavailability of PF-04191834 when dosed as an Immediate Release tablet~     compared with solution following single and multiple dosing.~   "
190965|NCT01064791|"~     This study will assess the safety and efficacy of different doses of sotrastaurin when~     combined with tacrolimus for the prevention of acute rejection after de novo renal~     transplantation.~   "
190966|NCT01064778|"~     The investigators propose examine the effects of the dietary factor glycemic index (GI) on~     brain areas that control food intake and hunger. This knowledge could help design dietary~     approaches that decrease hunger, and thus promote new weight loss strategies.~   "
190967|NCT01064765|"~     This study is designed to determine if a relationship exists between problems with memory,~     attention, learning, insight and executive function and self management in heart failure.~   "
190968|NCT01064752|"~     This will be an uncontrolled, open-labelled pilot study exploring whether minocycline has a~     measurable and selective effect on HIV infection of the central nervous system.~   "
190969|NCT01064739|"~     The purpose of this study is to learn how plants can play a role in gain/loss of sodium in~     the urine and in the regulation of blood pressure. Dopamine is a chemical mostly present in~     the brain and kidneys which assists in regulation of the body's salts (sodium and potassium).~     Fava beans contain a lot of the chemical that increases the production of dopamine by the~     kidneys.~      The purpose of these studies is to characterize the diuretic effects of dietary catecholamine~     sources in healthy individuals. Specific aims are:~        1. To determine the effect of dietary dopa sources on plasma and urinary catecholamines.~        2. To investigate the capacity of botanical dopaminergic agents (fava beans) to induce~          natriuresis in a short term study.~        3. To provide preliminary data on the effects of dietary dopa on heart rate and blood~          pressure.~      In these studies, we will test the null hypothesis (Ho) that urinary sodium excretion will~     not differ in healthy volunteers after consumption of a fixed-sodium study diet and the study~     diet plus fava beans.~   "
190970|NCT01064726|"~     After a nasal allergen challenge it should be possible to measure markers of inflammation~     that may be useful to assess the properties of future drugs. If these markers are~     reproducible and impacted by the study drugs they could be useful for future drug~     development.~   "
190971|NCT01064713|"~     The goal of this clinical research study is to learn if tesetaxel can help to control~     metastatic melanoma. The safety of this drug will also be studied.~   "
190972|NCT01064700|"~     The primary aim of this research was to examine the influence of bright light on anxiety in~     high-anxious young adults. In an acute exposure study, participants were randomly assigned to~     45 min of either (1) bright light (3,000 lux) or (2) a placebo inactivated negative ion~     generator. Treatments were initiated ≤1 hr after awakening. At 10 min before and 30 min after~     the treatments, state anxiety, mood, and blood pressure were assessed.~      Following the acute exposure study, participants performed a 5-week study. Following a a~     1-week baseline, participants were randomly assigned to four weeks of daily exposure to~     either (1) bright light (45 min/day; 3,000 lux) or (2) placebo inactivated negative ion~     generator, which were initiated ≤1 hr after awakening. Before and after the experiment,~     clinical ratings were conducted with the Hamilton Anxiety Scale, the Hamilton Depression~     Scale, and the Clinical Global Impressions scale (CGI). Following baseline, and following~     each week of treatment, blood pressure, as well as questionnaires for state anxiety,~     depression, mood, sleep, and side effects were assessed.~   "
190973|NCT01064687|"~     The purpose of this study is to determine if LY2189265 is effective and safe in reducing~     hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants~     with Type 2 Diabetes. The participants must also be taking metformin and pioglitazone.~   "
190974|NCT01064674|"~     Due to rising importance of cardiovascular disease before and after renal transplantation we~     have changed our standard diagnostic procedure and perform stress echocardiography and~     myocardial scintigraphy. We would like to monitor these results and the outcome of our~     patients.~   "
190975|NCT01064661|"~     We are conducting a study to learn if probiotics, which are live bacteria found in food like~     yogurt and cheese, will improve symptoms of abdominal pain. Individuals participating in this~     study will take probiotic pills to see if this affects the expression of certain pain~     receptors in the intestines that relate to pain sensation. Biopsies will be taken from the~     colon before subjects take the probiotic pills. Subjects will then be given one of two~     different types of probiotic pills to take for 3-4 weeks. After taking the supplements, more~     biopsies will be collected to see if any changes have taken places. This study requires one~     screening visit and two clinic visits to UNC hospital. Subjects will also complete daily~     diary cards for 2 weeks during the study to record their symptoms and also collect 2 stool~     samples.~   "
191071|NCT01063413|"~     The purpose of this study is to compare the effect of two after-school programs on children's~     physical activity, fitness, body composition, and academic performance.~   "
190976|NCT01064648|"~     This randomized phase I/II trial is studying the side effects and best dose of cediranib~     maleate when given together with pemetrexed disodium and cisplatin and to see how well it~     works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy,~     pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Cediranib maleate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed~     disodium and cisplatin together with cediranib maleate may kill more tumor cells.~   "
190977|NCT01064635|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast~     cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen~     of letrozole is most effective in treating breast cancer in postmenopausal women who have~     received tamoxifen.~      PURPOSE: This randomized phase III trial is comparing different regimens of letrozole to see~     how well they work in treating postmenopausal women with stage I, stage II, or stage III~     breast cancer previously treated with tamoxifen.~   "
190978|NCT01064622|"~     This randomized phase I/II trial is studying gemcitabine hydrochloride and vismodegib to see~     how well they work compared with gemcitabine hydrochloride alone in treating patients with~     recurrent or metastatic pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Vismodegib may slow the growth of tumor cells.~     It is not yet known whether giving gemcitabine hydrochloride together with vismodegib is more~     effective than gemcitabine hydrochloride alone in treating patients with pancreatic cancer.~   "
190979|NCT01064609|"~     Transbronchial lung biopsy (TBLB) is a bronchoscopic procedure used to obtain peripheral lung~     tissue. Small size and artefacts cause variable, and usually poor, diagnostic yield. The use~     of cryoprobes may allow for larger size and better quality biopsy samples.~      Objectives:To analyze the histological quality and immunohistochemical findings of samples~     obtained by cryoprobe compared with TBLB obtained by conventional forceps and to assess the~     safety and complications of TBLB with cryoprobe versus the conventional method.~      Methodology:~      Prospective randomized study of 80 patients. The transbronchial lung biopsy was indicated for~     diagnoses of a interstitial lung disease. In both procedures the videobroncoscopy used will~     be a Olympus 260-T.~      The transbronchial lung biopsy will be carried out with conventional forceps (Boston ® Biopsy~     Forceps, Ref 1556 and Olympus ® FB-19E) and cryoprobe (Erbokryo AC ®). TBLB will be performed~     by fluoroscopy guided and the cryoprobe or forceps will place in an area of the peripheral~     lung previously selected according to CT findings. Lung biopsies will be processed: The~     samples submitted for histological analysis will be fixed in formalin and embedded in~     paraffin. Staining will perform with hematoxylin-eosin and Masson's trichrome and the samples~     will be analyzed by a pathologist according to a protocol. The samples submitted to~     immunohistochemical study will be frozen (liquid nitrogen) for later transport.The specifical~     monoclonal antibodies will be used for immunohistochemical analysis.~   "
190980|NCT01064596|"~     After bariatric surgery , thromboembolics complications are major cause of mortality.~     However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is~     superior to HBPM, and is a good treatment for this population. Pharmacokinetics information~     with Fondaparinux in this population are rare.~   "
190981|NCT01064583|"~     To characterize potential vascular long-term effects of flavanols in patients with peripheral~     artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study~     will be performed in 62 patients randomized in two groups. Patients will twice daily receive~     either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days~     months.~   "
190982|NCT01064570|"~     Prospective use of RT-PCR for PML/RARa might be used to guide a total tehrapy approach in~     APL, including refined diagnosis, front-line treatment, assessment of response and~     anticipated salvage therapy for patients who undergo molecular relapse.~   "
190983|NCT01064557|"~     The main purposes of the AIDA protocol are to test the role of intermittent maintenance~     therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine~     of both in PCR negative patients at the end of the consolidation phase and to evaluate the~     role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the~     end of the consolidation phase.~   "
190984|NCT01064544|"~     Previous research has shown that sleep quality in hemodialysis patients is disturbed. One of~     the possible explanations is an insufficient or disturbed melatonin rhythm. Melatonin rhythm~     is regulated by exposure to light. In this feasibility study, the investigators examine the~     effects of light therapy during dialysis on sleep, melatonin rhythm and mood.~   "
190985|NCT01064531|"~     The objectives of this study are to assess migration of the MIS Stem compared to the Synergy~     Hip System, and to assess the long-term safety and effectiveness of the study device using~     Radiostereometric Analysis (RSA). This study will document any device-related surgical or~     post-operative complications and adverse radiographic observations.~      Patients meeting the entrance criteria specified in this protocol will be randomized as they~     become available.~   "
190986|NCT01064518|"~     The purpose of this study is to find out if an investigational drug, called RT001 Botulinum~     Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and~     hairline called crow's feet, also known as lateral canthal lines.~   "
190987|NCT01064505|"~     This is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where~     active study drug (QPI-1007) will be given to all patients who participate.~      This study will determine whether QPI-1007 is safe when it is injected into the eye. The~     study will also reveal if there are any side effects of the drug and how long it takes for~     the body to clear the drug.~   "
190988|NCT01064492|"~     PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being~     developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF~     04620110 will have anti diabetic effects through inhibition of intestinal triglyceride~     absorption and potentially weight loss. The primary purpose of this study is to evaluate the~     pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110~     administered to healthy volunteers.~   "
190990|NCT01064466|"~     Personalized or individualize Etoposide (VP-16) chemotherapy targeting the SCLC~     patient-specific biomarkers (Single Nucleotide Polymorphisms - SNPs of relative etoposide~     targets, topoisomerase II and CYP4503A4)~      Targeted SCLC chemotherapy with Etoposide (VP-16) and patient-specific biomarkers (SNPs)~      Individualize or personalize etoposide chemotherapy toward small cell lung cancer (SCLC) with~     maximizing effectiveness via assay single nucleotide polymorphisms (SNPs) of relative~     etoposide target - topoisomerase II, and minimizing risk via assay single nucleotide~     polymorphisms (SNPs) of relative etoposide target - CYP4503A4, based on precisely sequencing~     drug targets' genes.~   "
190991|NCT01064453|"~     Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy~     in real practice for the indication approved by Korea Food and Drug Administration (KFDA).~     This is non-interventional , prospective, multi-center study.Target number of patients is~     4500.~   "
190992|NCT01064440|"~     The purpose of this study is to evaluate whether intramuscular injections of VM202 into the~     calf is safe and effective in the treatment of critical limb ischemia.~   "
190993|NCT01064427|"~     The aim of this study is to identify the determinants of cancer-related fatigue, and the~     long-term effect of the different adjuvants treatments will be explored. A prospective~     longitudinal study in women diagnosed for the first time with stage I-III breast cancer and~     who have undergone surgery, has been designed to meet the study aims.~   "
190994|NCT01064414|"~     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of~     canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have~     reduced kidney function.~   "
190995|NCT01064401|"~     The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC~     HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in~     participants with relapsing remitting multiple sclerosis.~      The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in~     slowing functional decline and disability progression and maintaining quality of life in this~     participant population.~   "
190996|NCT01064388|"~     The purpose of this study is to determine the safety, tolerability and blood levels of~     AZD9742 after daily dosing for 14 days.~   "
190997|NCT01064375|"~     The purpose of this study is to evaluate the safety and immunogenicity of a CEA DNA~     immunisation approach in patients with colorectal cancer. The DNA plasmid, tetwtCEA, encodes~     wild type human CEA fused to a tetanus toxoid T helper epitope. The vaccine will be delivered~     using an intradermal electroporation device, Derma Vax (Cyto Pulse Sciences). The following~     will be assessed:~        -  The efficiency of priming immunological responses to CEA by intradermal administration~          of CEA DNA in combination with electroporation.~        -  The efficiency of boosting immunological responses to CEA by intradermal administration~          of CEA DNA in combination with electroporation in subjects already vaccinated with CEA~          DNA.~        -  GM-CSF will be administered to half of the subjects primed with CEA DNA in combination~          with electroporation and any possible adjuvant effects of GM-CSF will be evaluated.~   "
190998|NCT01064362|"~     Arixtra (fondaparinux sodium) was the first selective Factor Xa inhibitor to be marketed. As~     with all anticoagulants, an important adverse event associated with Arixtra use is~     haemorrhage. Previous studies using clinical trial and observational data show no difference~     in the risk of haemorrhage in patients treated with Arixtra compared to (low molecular weight~     heparins) LMWHs. This study will assess the risk of haemorrhage in major orthopaedic surgery~     patients (hip fracture surgery and/or hip/knee replacement surgery) treated with either~     Arixtra or LMWH for thromboprophylaxis and will provide additional observational data from a~     European country to strengthen the comprehensive review of haemorrhage and the post-marketing~     safety of Arixtra. All patients age 18 years and older with a primary discharge diagnosis for~     hip fracture surgery and/or a hospitalization for hip and/or knee replacement surgery from~     the PHARMO RLS database in the Netherlands are eligible for participation. For study~     inclusion patients must receive either Arixtra or LMWH as initial in-hospital~     thromboprophylactic agent and have at least three months in the PHARMO RLS database before~     cohort entry date. Patients with a history of hospitalization for haemorrhage, renal failure~     or liver failure in the past 3 months will be excluded. Descriptive statistics, including~     gender, age, length of treatment, co-morbidities, concomitant medications, and other~     covariates will be calculated.~      Data for this study were obtained from different registers in the PHARMO medical record~     linkage system (PHARMO RLS) in the Netherlands. The PHARMO medical record linkage system is a~     population-based patient-centric data tracking system that includes high quality and complete~     information of patient demographics, drug dispensing, and hospital morbidity records of~     approximately 2.3 million community-dwelling inhabitants of 48 geo-demographic areas in the~     Netherlands. The PHARMO registers are linked on a patient level and contain unprecedented~     accurate and complete information required for the study.~      The out patient database contains drug dispensing data in the U-Expo database are encoded~     according to standards based upon the Z-Index drug database (www.z-index.nl). Therefore, it~     is possible to identify and classify drug use in time, both on the basis of national and~     international classification schemes as well as on the basis of individual active ingredients~     and administration forms. Of each dispensed drug, the Anatomical Therapeutic Chemical (ATC)~     code, the dispensing date, the prescriber, the prescribed dosage regimen, the dispensed~     quantity, the cost and the estimated legend duration of use are available.~      The hospital pharmacy database comprises hospital pharmacy data collected in a growing number~     of non-academic hospitals in the Netherlands. Currently, data are collected on patient level~     for more than one million patients from a representative sample of non-academic hospital~     pharmacies scattered over the Netherlands. The hospital pharmacy database includes data on~     in-patient medication orders such as type of drug, dose, and time of administration and~     duration of use.~      The Dutch Medical Register (LMR) is the data source comprising all hospital admissions in the~     Netherlands (www.prismant.nl). These records include detailed information concerning the~     primary and secondary discharge diagnoses, diagnostic, surgical and treatment procedures,~     type and frequency of consultations with medical specialists and dates of hospital admission~     and discharge. All diagnoses are coded according to the International Classification of~     Diseases, 9th edition (ICD-9-CM). Currently, data until December 2008 are available.~   "
190999|NCT01064349|"~     This retrospective cohort study aims to improve our understanding of the current paradigm for~     treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We~     aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases~     diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the~     treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives~     are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to~     investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time~     interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence~     of brain metastasis as the first site of disease progression.~   "
191000|NCT01064336|"~     Since Idiopathic Thrombocytopenic Purpura (ITP) affects women who are of reproductive~     capacity and taking into account the lack of data concerning Eltrombopag (Promacta) use~     during pregnancy, the Eltrombopag (Promacta) Registry will be an essential component of the~     ongoing risk management for Eltrombopag (Promacta). The Registry will detect and record the~     events (live births, spontaneous abortions, stillbirths, elective terminations, therapeutic~     terminations, any serious pregnancy outcome, major and minor congenital anomalies, outcomes~     including preterm, small for gestation age, or intrauterine growth restriction adverse~     adverse effects on the following: immune system development, platelet number and function,~     neoplasm formation, bone marrow reticulin formation, thrombotic events) in the mother and/or~     the neonate/infant. The adverse events in the infant will be assessed through at least the~     first year of life. The Pregnancy Registry will compare the pregnancy and fetal outcomes of~     women exposed to eltrombopag Tablets during pregnancy to an unexposed control population.~     This study will be a prospective observational, exposure follow-up study.~   "
191001|NCT01064323|"~     Intermittent pneumatic compression (IPC) of the lower extremities is a well-established~     technique for preventing deep vein thrombosis (DVT) and for treating venous stasis. IPC will~     be done in the home for 3 divided hours every day for 4 weeks. Lab tests, brachial ultrasound~     and MRI testing will be performed at baseline and after 4 weeks of daily IPC therapy.~      See detailed description for increase in healthy control subjects.~   "
191002|NCT01064310|"~     This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in~     patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no~     prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients~     will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic~     sites of disease (0 and 1 vs. >=2). The study consists of two treatment periods of 10 weeks~     with a 2-week wash-out period between the two treatment periods. Patients will receive~     pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary~     objective of the study is to assess how the tolerability and safety differences between~     pazopanib and sunitinib translate into patient preference, defined by the patient's stated~     preference for which drug they may prefer to continue treatment with at end of study. The~     secondary objectives are to evaluate the reason for patient preference as assessed by a~     patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and~     quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose~     modification; and to evaluate safety.~   "
191003|NCT01064297|"~     Antiepileptic drugs (AEDs) are not indicated for use in pregnancy. However, women with~     epilepsy, and other approved indications including bipolar disorder, may require or be~     unintentionally exposed to AEDs during pregnancy. Prior to an AED being marketed there are~     few data available on drug safety in pregnancy: data from animal models may not translate~     directly to humans and pregnant women are routinely excluded from clinical trials. The~     International Lamotrigine Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1992~     to monitor the safety of lamotrigine during pregnancy.~   "
191004|NCT01064284|"~     The primary objective of the study is to assess the immunogenicity of VWF/FVIII and of rFVIII~     concentrates by determining the frequency of inhibitor development in previously untreated~     patients (PUPs) or minimally blood component-treated (MBCTPs) in the first 50 EDs or in the~     first 3 years from enrollment, whichever occurs first.~   "
191005|NCT01064271|"~     A Single-dose, Randomized, two-Period, Cross over Study~   "
191006|NCT01064258|"~     Background: In patients with obstructive sleep apnea, automatic continuous positive airway~     pressure machines (autoCPAP) are said to be capable of identifying various breathing~     abnormalities during sleep and to correct them by increasing progressively the positive~     pressure applied to the airway. Once breathing becomes normal, pressure slowly declines.~     AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised~     that normal breathing would not be recognised as such, and that pressure would increase even~     in a normal subject.~   "
191007|NCT01064245|"~     Cough is a common, disruptive and at times disabling symptom which often prompts patients to~     seek medical attention. Determining the cause(s) of chronic cough can be challenging, and~     costly. Asthma and other airway disorders are among the most common causes of chronic cough;~     and cough can be the sole symptom of asthma. Little is known about why some patients with~     asthma primarily cough and do not develop the other symptoms of asthma such as shortness of~     breath or wheeze. Improved understanding of the reasons for these different manifestations~     may lead to new and more effective treatment strategies. We have notices differences in~     pressure measurements inside the chest in patients who mostly cough during induced~     bronchoconstriction, which might be part of the explanation for varying symptoms. This study~     will compare lung mechanical responses during methacholine and mannitol-induced induced~     airway narrowing between typical asthma, cough variant asthma (CVA) and an airway~     inflammatory disorder that is not asthma.The purpose of this research is to explore the~     pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and~     methacholine-induced cough but normal airway sensitivity using mannitol and high-dose~     methacholine bronchoprovocation testing.~   "
191008|NCT01064232|"~     A Single-dose, Randomized, two-Period, Cross over Study~   "
191009|NCT01064219|"~     Intrauterine injection of hCG around the time of implantation may increase endometrial Treg~     cells and improve implantation. It has been demonstrated that regulatory T cells expand~     during pregnancy. hCG was found to be secreted by the embryo immediately after fertilization~     and has chemoattractant properties to Treg cells.~   "
191010|NCT01064206|"~     Background: Buerger's disease (thromboangiitis obliterans or TAO) is a rare disease (1/ 10~     000) characterized by the development of segmental thrombotic occlusions of the medium and~     small arteries of the extremities. Afflicted patients are mostly young, male, inveterate~     tobacco (or cannabis) smokers who present with distal extremity ischemia, ischemic ulcers, of~     the toes or fingers. Large arteries are typically spared, as are the coronary, cerebral, and~     visceral circulations. Patients with TAO often suffer from severe ischemic pain and tissue~     loss culminating in minor and major limb amputation. Clinical diagnostic criteria generally~     include history of tobacco abuse; age of onset less than 50 years; infrapopliteal, segmental~     arterial occlusions with sparing of the proximal vasculature; frequent distal upper extremity~     arterial involvement (Raynaud's syndrome or digital ulceration); superficial phlebitis; and~     exclusion of arteriosclerosis, diabetes, true arteritis, proximal embolic source, and~     hypercoagulable states.~      While the cause of Buerger's disease remains unknown, the disease onset and clinical course~     are inextricably linked to tobacco (or cannabis) abuse. Tobacco abstinence generally results~     in disease quiescence and remains the mainstay of treatment. For some unknown reason,~     clinicians observed that TAO patients rarely discontinue smoking even though amputation is~     usually the inevitable consequence and the only method available of controlling pain and~     ulceration. Few studies were realized and Hofer-Mayer and coll. found remarkable personality~     features comparing to coronary patients: TAO patients significantly changed their place of~     work more often, had more absenteeism from work, smoked more before the illness and continued~     to smoke more frequently during their illness, were more often single or divorced and had~     more conflicts in their relationships. Those facts led us to explore their psychopathology~     and their addictive profile.~      Purpose: Search the prevalence of personality disorders in Buerger's patients who present~     with tobacco or cannabis smoking.~      Hypothesis: Patients with Buerger's disease show remarkable personality features~     (psychological and addictive profile) which are vulnerability factors to stop smoking~     (tobacco or cannabis) compared to patients with atheromatous arteritis.~   "
191011|NCT01064193|"~     In vitro fertilization (IVF) is the only available solution for many couples with various~     forms of infertility. The embryo implantation step in the IVF procedure is a complex~     multistage process and represents the majority of the causes of the IVF failure. Several~     approaches have been evaluated to improve implantation rates but none has demonstrated its~     superiority. However, endometrial receptivity is important for pregnancy and several studies~     suggest that local injury to the endometrium of IVF patients improves the rates of embryo~     implantation, clinical pregnancy and live birth.~   "
191012|NCT01064180|"~     Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study of Dr. Reddys Under Fed Conditions~   "
191013|NCT01064167|"~     The aim of this prospective, randomized, double-blinded, placebo-controlled study was to~     evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the~     postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary~     artery bypass graphing (OPCAB) surgery.~   "
191014|NCT01064154|"~     Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study Of Dr. Reddys Under Fasting~     Conditions~   "
191015|NCT01064141|"~     The purpose of this study is to investigate the potential for co-administration of the first~     dose of CYD Dengue vaccine with childhood vaccination.~      Primary Objectives:~        -  To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or~          coadministered with childhood vaccines.~      Secondary Objectives:~        -  To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given~          alone or co-administered with childhood vaccines.~   "
191072|NCT01063400|"~     The purpose of this research is to examine the relationship between performance status rating~     and the actual amount of physical activity a subject does when it is measured by an activity~     monitor.~   "
191571|NCT01056822|"~     Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate~     sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a~     Dose Reduction of Tacrolimus. Maximiza Study.~   "
191016|NCT01064128|"~     Purpose:~      The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new~     technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is~     considered as painless procedure and better cosmetic effect but there are not any~     publications to study a possible different pain score and cosmetic effect in new techniques~     versus conventional laparoscopic hysterectomy. In this randomized controlled study the~     researchers have investigated the pain scores and cosmetic satisfaction by modified body~     image scale and cosmetic scar scale.~   "
191017|NCT01064115|"~     A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative~     Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys~     laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under Fed~     Conditions.~   "
191018|NCT01064102|"~     A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative~     Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys~     laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under~     Fasting Conditions.~   "
191019|NCT01064089|"~     This study is a phase I dose escalation, multi-center, open-label study of HSP990~     administered orally once weekly in adult Japanese and Korea patients with advanced solid~     malignancies.~   "
191020|NCT01064076|"~     This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous~     implantable defibrillator (S-ICD) System.~   "
191021|NCT01064063|"~     This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate~     Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.~   "
191022|NCT01064050|"~     A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of~     lung cancers with a high impact on survival and quality of life of these patients. The~     endoluminal resection of these tumors through interventional bronchoscopy can remove the~     tumor but fails to prevent the recurrence. A stent insertion could achieve this goal but this~     option was never proved in a prospective protocol.~      The aim of this study is to analyze the impact of stent insertion on the survival without~     symptoms of bronchial obstruction in patients treated for their cancer with and without a~     first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included~     after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect~     of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients~     with stent insertion) with a control arm (170 patients without stent). The inclusion period~     will last 3 years with one year of follow-up for each patient. The one-year survival without~     symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the~     treated zone) will be the main endpoint. All patients without symptomatic recurrence at one~     year will be controlled endoscopically. Survival and stent tolerance will be studied as~     secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each~     endoscopical situation (before and after resection, recurrence or side effects of stents)~     will be analyzed and registered by an independent committee of 3 international experts.~   "
191023|NCT01064037|"~     A placebo controlled, double-blind and randomized study to assess different doses of a new~     drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the~     well-being of patients with acute decompensated heart failure.~   "
191024|NCT01064024|"~     This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets,~     USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning~     when passing urine associated with uncomplicated urinary tract infections (uUTI)~   "
191025|NCT01064011|"~     Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in~     the United States. In the emergent setting, patients with obstructive hydrocephalus are~     routinely treated with placement of an external ventricular drain. This study will compare~     the effect of external ventricular drainage plus intraventricular thrombolysis versus~     external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients~     with hydrocephalus from intraventricular hemorrhage.~   "
191026|NCT01063998|"~     The ultimate goal of this project is to develop a simple non-invasive method to screen~     patients for potential kidney tumors.~   "
191027|NCT01063985|"~     The purpose of this study is to test a new mouse skin test extract on people who work with~     mice in a lab or through animal care. It has a higher level of the major allergen and~     therefore may be better at diagnosing mouse allergies in this population.~   "
191028|NCT01063972|"~     Our long-term goal is to improve smoking cessation treatment for rural smokers. The objective~     is to assess the effectiveness of a centralized disease management program for hospitalized~     smokers that coordinates care across treatment settings and links smokers to existing~     resources. Our central hypothesis is that Centralized Disease Management (CDM) will increase~     the use of smoking cessation treatments and lead to greater long term smoking cessation than~     Counseling alone. Demonstrating the effectiveness of a disease management program and~     identifying the critical components of such a program will provide a basis for improving the~     utilization of existing smoking cessation resources while enhancing the treatment of rural~     hospitalized smokers.~   "
191029|NCT01063959|"~     The purpose of this study is to determine laparoscopic sleeve gastrectomy is a safer surgery~     than the gastric bypass, gives similar weight losses and that the safety of gastric in~     private pay patients versus insurance patients will be similar. This is a retrospective chart~     review of intervention charts.~   "
191030|NCT01063946|"~     Primary Objectives:~        -  To determine the excretion balance and systemic exposure of radioactivity after~          intravenous infusion of [14C]-AVE8062 to humans~        -  To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to~          overall exposure~        -  To collect samples to determine the metabolic pathways of AVE8062 and identify the~          chemical structures of the main metabolites~      Secondary Objective:~        -  To assess the safety profile of the drug~   "
191226|NCT01061346|"~     This study is designed to test the effects on liver fat of varying fat intake in the presence~     of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as~     compared to glucose will increase the amount of hepatic lipid as measured by magnetic~     resonance spectroscopy.~   "
191227|NCT01061333|"~     This study will assess the Early Airway Response (EAR) associated change in forced expiratory~     volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of~     nedocromil, montelukast, and mometasone.~   "
191031|NCT01063933|"~     The purposes of this study are to evaluate the pharmacokinetics (affect the body has on a~     drug), and pharmacodynamics (affect the drug has on the body) and safety of an experimental~     intravenous (within a vein) flu medication, peramivir, in children. Participants will include~     63 hospitalized children with confirmed flu. Children will be grouped according to age and~     younger children will not receive drug until safety data from the groups of older children~     are reviewed. Hospitalized children may receive up to 5 doses of peramivir. Study procedures~     include: nasal/throat swabs, reporting any experienced side effects, physical examination~     including assessment of the nervous system, and blood sample collection. Participants will be~     involved in study related procedures for up to 28 days.~   "
191032|NCT01063920|"~     LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is~     rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric~     ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients~     receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or~     Naprosyn® 500mg (an approved treatment for OA).~   "
191033|NCT01063907|"~     The purpose of this study is to assess the safety and benefits of the investigational study~     drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of~     Multiple Myeloma (MM).~      The primary objectives:~        -  To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478~          in combination with bortezomib (Phase I);~        -  To assess the overall response rate (ORR) when subjects with advanced MM are treated~          (Phase II).~      The secondary objectives:~        -  To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with~          bortezomib (Phase I only);~        -  To evaluate for preliminary evidence of efficacy (Phase I);~        -  To determine progression free survival (PFS) and duration of response of KW-2478 with~          bortezomib (Phase II).~   "
191034|NCT01063894|"~     The objective of this study is to test the effects of breakfast on cognitive processing~     ability in children.~   "
191035|NCT01063881|"~     The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a~     setting similar to routine clinical practice.~   "
191036|NCT01063868|"~     The purpose of this study is to evaluate the safety profile of orally administered tapentadol~     ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral~     neuropathy (DPN) over long-term exposure of up to 1 year.~   "
191037|NCT01063855|"~     The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to~     placebo in men with premature ejaculation and erectile dysfunction who are currently being~     treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for~     erectile dysfunction.~   "
191038|NCT01063842|"~     The purpose of this study is to compare the number of osteoarthritis patients receiving~     titrated or increasing doses of tramadol hydrochloride/acetaminophen combination tablet~     (titration group) who discontinue treatment due to adverse events to the number of patients~     receiving a non-titrated dose of tramadol/hydrochloride/acetaminophen combination tablet who~     discontinue treatment due to adverse events.~   "
191039|NCT01063829|"~     The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the~     chances of the cytomegalovirus becoming active again and causing illness after an HBPC~     transplant (allogeneic stem cell transplant).~   "
191040|NCT01063816|"~     The purpose of this study is to determine the maximum tolerated dose of veliparib~     (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when~     administered in combination with carboplatin and gemcitabine in subjects with advanced solid~     tumors.~   "
191041|NCT01063803|"~     This open-label extension study will allow subjects who have completed either the~     3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103~     treatment and will provide data on the long-term safety and tolerability of ATN-103 in~     subjects with rheumatoid arthritis.~   "
191042|NCT01063790|"~     Pain after inguinal hernia repair surgery is common with more than 50% of patients reporting~     moderate to severe acute pain following surgery. Analgesics are helpful in managing this pain~     but patients can be reluctant to take analgesics due to potential adverse effects such as~     nausea, vomiting or constipation. Patients may also be concerned about addiction to~     analgesics or they may believe that experiencing moderate to severe pain after surgery is to~     be expected.~      The purpose of this study is to investigate the impact of an individualized education program~     regarding pain and management of adverse effects on pain after inguinal hernia repair~     surgery.~   "
191043|NCT01063777|"~     The purpose of this study is to evaluate the long term effect of exercise therapy and patient~     education compared to patient education only in individuals with hip OA, and to evaluate~     predictive factors for changes in hip osteoarthritis both clinically and on x-ray.~      Main hypothesis H01: There are no significant long term ( 2 years) differences in hip~     function, quality of life, physical function and radiological changes between those~     individuals who went through a patient education program and a 12 week exercise therapy~     program compared to patient education program only.~      Material and Methods:~      109 patients with radiographically verified hip OA are included in the randomized controlled~     trial; randomized to 12 week exercise therapy program and patient education (n=55) and~     patient education program only (n=54).~      Data will be collected 2 years after completed intervention period in the original RCT, and 6~     months and 2 years postoperatively for those patients who have undergone total hip~     arthroplasty.~      The main outcome is:~      The Disease Specific WOMAC-Index.~      Secondary outcome measures are:~      Hip X-ray, SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain,~     isokinetic muscle strength tests, 6 minute walk test, Åstrand's bike test, range of motion.~      Status:~      This study is a prolongation of an on-going RCT (3a-2005-NAR). The inclusion, intervention~     and follow-ups including 1 year follow-up is completed. 2 year post-intervention follow-up~     will be completed in 2010, 2 year follow-up postoperative for patients undergoing total hip~     artroplasty will continue throughout 2011.~      The study will be carried out: NAR-Orthopedic Centre, Ullevaal University Hospital.~   "
191044|NCT01063764|"~     Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses~     up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese~     pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with~     1 or 2 anti-epileptic drug(s).~   "
191045|NCT01063751|"~     This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular~     Shell for primary total hip replacement (THR) with a cementless application in a consecutive~     series of patients who meet the eligibility criteria. Half of the cases will use the X3®~     polyethylene insert alone as the bearing surface; the other half will use the MDMTM liner~     coupled with a compatible ADM/MDMTM X3® insert as the bearing surface.~      The success rate, defined as freedom from acetabular revision for any reason, for hips~     implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with~     similar technology as reported in the literature and Trident® X3® Study historical control at~     5 years postoperative.~   "
191046|NCT01063738|"~     The study will examine the effect of amino acid supplements and enhanced physiotherapy on~     physical recovery following critical illness in intensive care.~   "
191047|NCT01063725|"~     The purpose of this study is to test the effects of Femarelle ( a plan-derived SERM) on hot~     flushes and quality of life in menopausal women. Our hypotheses are that compared to placebo,~     Femarelle reduces the daily number of hot flushes and their severity and also improves the~     quality of life as measured by validated dairies and questionnaires.~   "
191048|NCT01063712|"~     The purpose of this study is to evaluate the safety and the effectiveness of the device~     Nit-Occlud® PDA-R in the percutaneous closure of patent ductus.~   "
191049|NCT01063699|"~     This study evaluated laparoscopic (videosurgery) versus conventional (open surgery) Kasai~     portoenterostomy (anastomosis of small intestine to the liver hilus) in children with biliary~     atresia. The study was stopped due to lower survival with native liver 6 months after the~     laparoscopic operation. Follow-up after 24 months confirmed superior results after~     conventional operation.~   "
191050|NCT01063686|"~     Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When~     PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also~     a high risk of neonatal and maternal morbidity. When the diagnosis of PPROM is uncertain by~     physical examination, additional tests are needed. These tests have false positive and false~     negative rates. The gold standard for diagnosing PPROM is amniocentesis and dye test. This~     procedure has a risk of infection and abortion.Our hypothesis is that by using a cervical cap~     for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which~     are uncertain. Our study group will be pregnant women gestational age 14-23, suspected of~     having PPROM.~   "
191051|NCT01063673|"~     Running patterns are thought to have a major influence on the development of Running Related~     Injuries (RRI), however to studies have documented such relationship. Thus, the aim of the~     study is to investigate the association between running patterns and overuse injuries in~     runners.~   "
191052|NCT01063660|"~     This is a multicenter, multinational, non-randomized, non-controlled open-label phase II~     trial to evaluate the safety and efficacy of treosulfan in a combination regimen with~     fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in~     patients with AML.~      The aim is to demonstrate a clinical benefit compared with historical data on intravenous~     busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication~     conditioning before allogeneic stem cell transplantation.~   "
191053|NCT01063647|"~     Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp.,~     combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell~     transplantation of patients with hematological malignancies, but non-eligible to standard~     conditioning treatment.~   "
191054|NCT01063634|"~     This is a non-inferiority randomized study to compare a plastic stent without central lumen~     (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the~     common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.~   "
191055|NCT01063621|"~     This is a extended long-term safety study in Parkinson's disease patients who have motor~     response complications on levodopa therapy and completed 12 weeks administrations of KW-6500~     in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of~     KW-6500 are evaluated.~   "
191056|NCT01063608|"~     This project may help to answer several fundamental questions related to public health~     regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy:~      What is the immunologic efficacy in terms of antibodies response of the vaccination against~     the seasonal (2009-2010) influenza virus and against the A(H1N1)v virus in the clinical~     staff?~      Moreover, it may help to answer questions related to the use of a vaccine against influenza~     virus variants emerging in the French population:~        1. Before the vaccination:~             -  What is the status of the residual anti-H1N1 seasonal viruses immunity and of the~               anti-A(H1N1)v immunity in the population stratified by age and taking into account~               the multiplicity of the prior seasonal vaccinations?~             -  What is the level of the cellular and humoral cross-reactivity between the~               different H1N1 strains?~        2. After the vaccination:~             -  What is the intensity of the anti-vaccine immune response as a function of the age~               of the population ad of the prior seasonal vaccinations?~             -  What is the level of the cellular and humoral cross-reactivity after vaccination as~               a function of the age of the population and of the multiplicity of the prior~               seasonal vaccinations?~   "
191057|NCT01063595|"~     The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas~     SD in terms of recovery of coagulation factors and other haemostatic parameters. The~     secondary objective of the study was to compare the safety and tolerability of Octaplas LG~     with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse~     event monitoring.~   "
191058|NCT01063582|"~     Study of noise generated by military-type aircraft and equipment maintenance in relation to~     non-auditory effects that impact with the body of the crew and ground staff can cause cardiac~     pathologies~      Hypothesis of work: The pilots and the technical personnel of maintenance that work before~     the exhibition of noise generated by planes hunt F-16, or equipments of maintenance of the~     same ones, present major risk of a cardiac affectation, which demonstrates in changes in the~     normal pace of the heart, in his function of bomb or in hemodynamic conditions.~   "
191228|NCT01061320|"~     The purpose of this study is to demonstrate the efficacy of alpha tocopherol for prevention~     contrast-induced nephropathy in CKD patients undergoing elective coronary procedures.~   "
191059|NCT01063569|"~     Addison's disease is a rare condition which in most cases is caused by autoimmune destruction~     of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens.~     Unrecognized the disease is life threatening, but with proper treatment patients can live~     near normal lives.~      The conventional glucocorticoid replacement therapy renders the cortisol levels~     unphysiological, which may cause symptoms and long-term complications. Glucocorticoid~     replacement therapy is technically feasible by continuous subcutaneous hydrocortisone~     infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further~     evaluate CSHI treatment in terms of metabolic effects, effects on health-related~     quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover~     design.~   "
191060|NCT01063556|"~     The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in~     subjects with end-state renal disease who were receiving haemodialysis.~   "
191061|NCT01063543|"~     Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A~     population pharmacokinetic model of fondaparinux, based on data obtained in patients included~     in phase II/III trials, has been described. However, the validity of this model in everyday~     practice needed to be confirmed. This study was a multicenter, prospective cohort study in~     consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were~     recorded in 809 patients. Population parameters and inter-individual variability were~     estimated using NONMEM VI software. A two-compartment model with first-order absorption best~     described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual~     variability were body weight, age and creatinine clearance estimated by the simplified~     Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate~     renal failure increased drug exposure. These results suggest that fondaparinux~     pharmacokinetics need to be confirmed in patient populations not fully assessed in phase~     II/III studies~   "
191062|NCT01063530|"~     The purpose of the study is to confirm the clinical effectiveness and safety of topical~     diammine silver fluoride (DASF) as a tooth desensitizer in adulst by comparing it to the~     application of sterile water.~      The study will be conducted in two different sites in Peru. Participantes will be 144 adults~     who will have at least one vital maxillary or mandibular cuspid or premolar with a cervical~     defect on the buccal surface and clinical hypersensitivity in response to air. Subjects will~     be randomly assigned to a topical application of DAS or sterile water.~      The reduction of pain (sensitivity) using a 100 mm VAS, will be determined. Safety will be~     also determined by evaluating the gingival condition (erythema, white changes, ulceration,~     staining) before and ater the application of the products. The evaluation times will be 24~     hours and 7 days.~   "
191063|NCT01063517|"~     To assess the efficacy of olaparib when given in combination with paclitaxel compared with~     paclitaxel alone as defined by progression-free survival (PFS), in all patients with~     recurrent and metastatic gastric cancer who progress following first-line therapy~   "
191064|NCT01063504|"~     The investigators will study how well knee joint prostheses become fixed to the bone when~     patients get teriparatide, compared to placebo. Measurements will use high resolution 3D~     radiography (radiostereometry, RSA).~   "
191065|NCT01063491|"~     Aortocoronary bypass graft failure is common and is associated with high morbidity and~     mortality. Failure of saphenous vein grafts is more common than failure of internal mammary~     artery grafts. Whether early graft angiography can reduce bypass graft failure remains~     unknown. The Cardiac CAtheterization for Bypass Graft Patency Rate Optimization (CABG-PRO)~     randomized-controlled pilot study is a phase III, double-blind, randomized-controlled pilot~     trial that will randomize 170 patients undergoing coronary artery bypass graft surgery to~     early (before dismissal) graft angiography vs. no early graft angiography. Coronary~     angiography will be performed at 12 months, to determine whether compared to no early graft~     angiography, early graft angiography will result in:~        1. lower per patient angiographic bypass graft failure (in at least one graft) rates~          (defined as ≥75% diameter stenosis in at least one bypass graft) (primary efficacy~          endpoint)~        2. lower per graft failure rates, per graft occlusion rates, and per patient bypass graft~          occlusion rates (in at least one bypass graft) (secondary endpoints)~        3. lower incidence major adverse cardiac events (death, nonfatal myocardial infarction,~          nonfatal stroke, coronary revascularization, and composite of death/myocardial~          infarction) (secondary endpoint)~      Intravascular ultrasonography and near-infrared spectroscopy will also be performed in at~     least one bypass graft at baseline (in the early graft angiography group only) and at~     12-month angiographic follow-up to evaluate the structural bypass graft changes occurring~     after coronary artery bypass graft surgery (secondary endpoint).~   "
191066|NCT01063478|"~     The purpose of this study is to understand the effects (good and/or bad) of the addition of~     RAD001 to standard radiation and chemotherapy (cisplatin and pemetrexed) for patients with~     non-small cell lung cancer.~   "
191067|NCT01063465|"~     The purpose of this study is to measure the mechanical properties of healing Achilles tendons~     in humans after early controlled weightbearing, compared with a control group in a~     randomized, single-blinded trial. The mechanical properties are measured using~     radiostereophotogrammetic x-rays (RSA).~      Hypothesis: Early weightbearing improves mechanical properties of the healing Achilles~     tendon.~   "
191068|NCT01063452|"~     The primary objective of this study is to evaluate the impact of the Atkinson Product Design~     urinary slide valve on patient morbidity and freedom as measured by impact on activities of~     daily living (ADL) and quality of life (QOL). Secondary objectives include assessing the~     impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL~     and QOL.~   "
191069|NCT01063439|"~     The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide,~     cytarabine and melphalan (BuEAM) including intravenous busulfan instead of BCNU of standard~     BEAM as a conditioning for autologous stem cell transplantation in patients with NHL.~   "
191070|NCT01063426|"~     Reload of high dose statin may have potential for preventing deep vein thrombosis (DVT) in~     patients on statin undergoing total knee replacement arthroplasty.~      A body of evidence have been reported that reloading of atorvastatin have efficacy in~     reducing periprocedural myocardial infarction and contrast induced nephropathy. These effects~     are considered to be mainly due to their antioxidant anti-thrombotic and anti-inflammatory~     property.~      We, therefore, hypothesize that high dose atorvastatin re-loading may prevent DVT.~   "
191073|NCT01063387|"~     This study is an open-label, randomized study, which is designed to investigate the efficacy~     of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node~     (PAN) and supraclavicular lymph nodes, and also on improving disease-free survival of locally~     advanced uterine cervical cancer. This study includes a translational research component in~     that all the primary tumors and lymph node are stained with Sema4c, before randomization.~     According to the investigators study result, patients with more pelvic lymph node metastasis~     are more likely to develop distant metastasis including the recurrences at PAN and~     supraclavicular lymph node. Primary cervical cancer tissues and lymph nodes are examined for~     expression of Sema4c just after registration, and before the patients are randomized to each~     arm (pelvis only vs. EFI). The investigators expect a higher benefit of EFI in patients with~     Sema4c-positive lymph node.~   "
191074|NCT01063374|"~     A low glycemic index diet may improve glycemic control and reduce plaque buildup in arteries~     of those with type 2 diabetes. Subjects will be randomly assigned to receive dietary advice~     on either a low glycemic index diet, or a high cereal fibre diet, for three years.~   "
191075|NCT01063361|"~     Healthy individuals with type 2 diabetes will receive intensive counseling on food selection~     to improve glucose control using either high cereal fiber dietary strategies or low glycemic~     index foods emphasizing dried legumes and their products. The treatments will last 3 months~     with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for~     either or both diets, then use of high fiber and/or low glycemic index foods in the diet may~     provide another potential way to improve glucose control and lower cholesterol levels in~     non-insulin dependent diabetes.~   "
191076|NCT01063348|"~     The goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine~     to placebo in pathologic skin picking. Thirty subjects with pathologic skin picking will~     receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The~     hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in~     patients with pathologic skin picking. The proposed study will provide needed data on the~     treatment of an often disabling disorder that currently lacks a clearly effective treatment.~   "
191077|NCT01063335|"~     Background:~      - The CB1 receptor is a protein in the brain that is targeted by the active ingredients in~     cannabis (marijuana). Brain systems that react to cannabis may be involved in the causes and~     symptoms of schizophrenia and schizoaffective disorder. For instance, research studies have~     shown that the number of CB1 receptors may be different in people with schizophrenia, and~     there may be differences in the receptors themselves. Researchers are interested in using~     positron emission tomography (PET) to study CB1 receptors in people with and without~     schizophrenia, using a chemical tracer that attaches specifically to CB1 receptors.~      Objectives:~      - To determine whether the CB1 receptor brain protein is different in people with and without~     schizophrenia.~      Eligibility:~      - Individuals between 18 and 55 years of age who either have been diagnosed with~     schizophrenia/schizoaffective disorder or are healthy volunteers.~      Design:~        -  Participants in the study must have previously enrolled in the National Institute of~          Mental Health protocol A Neurobiological Investigation of Patients with Schizophrenia~          Spectrum Disorders and Their Siblings (95-M-0150).~        -  Participants will provide blood samples to test for the gene that contains information~          on the specific type of CB1 receptor each participant has.~        -  Participants will have a PET scan and/or a magnetic resonance imaging (MRI) scan.~        -  The PET scan will last approximately 2 hours. Participants will receive an injection of~          a small amount of chemical tracer to improve the quality of the images taken during the~          scan.~        -  The MRI scan will last approximately 1 hour.~   "
191078|NCT01063322|"~     Background:~      - Mitral regurgitation, or leaking of the mitral heart valve, is usually studied and assessed~     with an ultrasound test called a two-dimensional (2D) echocardiogram. While this test has~     proved very useful, technological improvements have helped researchers develop ways to study~     the heart valves using imaging with three-dimensional (3D) capabilities. In addition,~     recently developed magnetic resonance imaging (MRI) techniques may be able to provide better~     information about the causes and severity of the leak. Researchers are interested in testing~     these new techniques to determine their usefulness for patients with mitral regurgitation.~      Objectives:~      - To evaluate newer methods of studying mitral regurgitation severity using real-time 3D~     echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMRI).~      Eligibility:~      - Individuals at least 21 years of age who have been diagnosed with more than mild mitral~     regurgitation.~      Design:~        -  Participants will have two procedures as part of this study: an echocardiogram and an~          MRI scan.~        -  For the echocardiogram, participants will have an ultrasound scan with a special kind of~          probe. Participants may also receive an injection of a contrast agent to provide a~          better image of the heart on the scan. The scan will take approximately 1 hour to~          complete.~        -  For the MRI scan, participants will have a standard MRI with special pads placed on the~          chest to provide better imaging of the heart. The scan will usually take between 45 and~          90 minutes to complete.~   "
191079|NCT01063309|"~     Background:~        -  Atherosclerosis, the arterial plaques or blockages that cause heart disease, develops in~          many people by the time they are in their mid-20s. The rate of atherosclerosis in~          patients with immune system disorders has not been well studied, but it may be very~          different from the general population.~        -  Patients with chronic granulomatous disease (CGD) produce less of a group of molecules~          known as free radicals, which help to fight infection and may play a role in the~          development of atherosclerosis. Patients with CGD may develop atherosclerosis much more~          slowly than people without CGD. On the other hand, carrier mothers of children with~          genetically-linked CGD often have problems with autoimmune problems in addition to a~          problem with making free radicals. Patients with other immune system disorders also have~          very different responses to infection, and many of them also have autoimmune-like~          problems that may change the risk of developing atherosclerosis.~      Objectives:~      - To study the prevalence of atherosclerosis in patients with immune system disorders,~     compared with healthy individuals.~      Eligibility:~      - Individuals at least 18 years of age who either have been diagnosed with an immune system~     disorder or are healthy volunteers.~      Design:~        -  The active part of the study involves one or two visits to the National Institutes of~          Health Clinical Center for a series of imaging tests and scans.~        -  Participants will have the following tests during the active part of the study:~        -  (1) CAT scan to obtain images of the chest arteries and measure the amount of calcium in~          the artery walls.~        -  (2) Magnetic resonance imaging scan to obtain images of the coronary and carotid~          arteries in the chest and neck.~        -  (3) Electrocardiogram to provide data on current heart function.~        -  (4) Blood samples to provide data on heart, kidney, and immune system function.~        -  Participants will be contacted every 2 years in the future for up to 30 years to~          determine whether they have developed heart disease. Researchers will ask participants~          to provide contact information for two other people who may likely know how to get in~          touch with the participant in the future.~   "
196695|NCT00988754|"~     The purpose of the study is to determine whether a school based health promotion program in~     secondary schools is effective with respect to an increase of physical activity, physical~     fitness and health.~   "
191080|NCT01063296|"~     Cervical cancer is a major health problem for Chinese women. It is estimated that nearly~     100,000 new cervical cancer cases occur in China every year, which accounts for about 20~     percent of global new cases. Surgery and radiotherapy are two major radical treatment methods~     for IB-IIB cervical cancer. Unlike the United States and some other countries, most of~     operable women with IB-IIB cervical cancer received radical surgery other than radiotherapy~     in China. Patients with recurrence risk factors (lymph node metastasis, deep stromal~     invasion, positive lymphatic vascular space, et al. ) also received adjuvant therapy after~     surgery, such as radiotherapy or chemoradiotherapy that are recommended in the NCCN~     guidelines. However, in China a substantial part of patients especially those admitted to~     tertiary hospitals received several courses of chemotherapy instead of radiotherapy if they~     had recurrence risk factors .~      In our previous study, we found that patients with intermediate risk factors (deep stromal~     invasion, positive lymphatic vascular space, bulky tumor>4cm) had better disease-free~     survival and recurrence-free survival when they received chemotherapy compared with~     radiotherapy. The objective in this study is to investigate whether the advantage of~     postoperative chemotherapy is a result of circulating tumor cells (CTC) in some of the~     patients with intermediate risk factors.~   "
191081|NCT01063283|"~     The purpose of this study is to see if higher dose of bevacizumab can be taken safely by some~     patients and if changes in the dose of bevacizumab have any effect on blood pressure.~   "
191082|NCT01063270|"~     The purpose of this research study is to further evaluate the efficacy of two treatment~     regimens for the treatment of hidradenitis suppurativa. This is a randomized controlled~     study. Patients will be randomly assigned to an arm of the study.~   "
191083|NCT01063257|"~     This study aims to determine the maximal tolerated dose (MTD) and dose limiting toxicities~     (DLTs) of low dose IV clofarabine for MDS patients after treatment failure of azacitidine.~   "
191084|NCT01063244|"~     We will compare the use of foley bulb catheters placed in the cervix for ripening of the~     cervix for labor induction,.~   "
191085|NCT01063231|"~     Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to~     conventional colonoscopy.~   "
191086|NCT01063218|"~     The main goal of this present study is evaluate the decreasing of necessity of topic~     corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the~     correct emollients.~   "
191087|NCT01063205|"~     The purpose of this study is to determine the effects of treatment with NAC, compared to~     treatment with placebo, on cue- and methamphetamine (MA)-induced craving and MA subjective~     effects in non-treatment-seeking MA-dependent human volunteers. We also aim to determine the~     effects of treatment with NAC, compared to treatment with placebo, on the reinforcing effects~     of MA by measuring MA self-administration in non-treatment-seeking MA-dependent human~     volunteers.~   "
191088|NCT01063192|"~     The primary end point is to evaluate the time to progression after gemcitabine alone versus~     Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy~     in locally advanced pancreatic cancer.~      The secondary end points are to evaluate the disease control rate, overall survival time,~     toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy~     as well as the disease control rate after inductional chemotherapy alone in locally advanced~     pancreatic cancer. Translational research including pharmacogenomic study and biomarker study~     will also be done concomitantly.~   "
191089|NCT01063179|"~     The proposed study will evaluate whether the combination of VELCADE, Thalidomide , Melphalan~     and Prednisone (V-MPT), as induction treatment for newly diagnosed elderly MM patients,~     improves outcomes compared to the combination VELCADE-MP.~   "
191090|NCT01063166|"~     The Computer-Assisted Self-administration of Ethanol (CASE)will be administered twice, at the~     ages 18 and 20, in a prospective study of 80 adolescents living in the Dresden area. The~     sample will be recruited for a differential family history of alcoholism (FHA) and gender,~     with inventories of alcohol use disorder (AUD) symptoms and personal recent drinking history~     (RDH) obtained prior to each CASE session.~   "
191091|NCT01063153|"~     The purpose of this research study is to study a device called an electroencephalograph (EEG)~     in the diagnosis of treatment of attention deficit hyperactivity disorder (ADHD) in adults.~     People with ADHD have symptoms such as difficulty sustaining attention, organizing, and~     managing impulsivity. They can have trouble in school, at work, and at home. Subjects with~     ADHD who participate in this study will be given a once daily stimulant medication called~     osmotic release methylphenidate (Concerta) for 6 weeks, and have EEG testing done before and~     after the treatment period. Subjects will perform a computer based cognitive task during EEG~     testing. The U.S. Food and Drug Administration has approved osmotic release methylphenidate~     (Concerta) for the treatment of ADHD in adults and children. Similar procedures, without~     medication, will be performed with a sample of healthy adults without ADHD.~   "
191092|NCT01063140|"~     Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to~     the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently~     the only practical method to obtain this plasma is to immunize normal volunteer Source Plasma~     donors and collect their plasma while titers are adequate. The use of rabies vaccine for~     immunization of normal Source Plasma donors is currently limited to a level that, while~     protective for the individual, is unsuitable for production of rabies immune globulin.~      The objective of this study is to obtain efficacy and safety data regarding the rabies~     boostering program to demonstrate that:~        1. Rabies immune plasma production can be substantially increased by giving booster doses~          to previously immunized donors whose titers are below 10.0 IU/mL.~        2. It is safe for normal Source Plasma donors to receive booster doses of rabies vaccine on~          a regular basis.~      This study utilizes two rabies vaccines approved by the FDA, Imovax® (Sanofi-Pasteur) and~     RabAvert® (Novartis).~   "
191093|NCT01063127|"~     The purpose of this study is to quantify the relative contribution of improved insulin~     sensitivity and improved insulin secretion to the glycaemic effect of bariatric surgery.~   "
191251|NCT01061021|"~     HIV prevention interventions are needed to assist people living with HIV/AIDS to adhere to~     their medications and not transmit the virus to others. This study is testing a behavioral~     intervention designed to address both medication adherence and risk reduction in people~     living with HIV/AIDS. It is hypothesized that the experimental behavioral intervention will~     show improved medication adherence and safer sexual behaviors compared to a comparison group.~   "
191094|NCT01063114|"~     There are two types of external radiation treatments (proton beam and photon beam). As part~     of the participant's treatment, they will receive radiation to the entire central nervous~     system (CNS); this is known as craniospinal irradiation (CSI). In the past, photon radiation~     therapy has been used for CSI. In this study we will be examining the effects of proton beam~     radiation therapy. Studies have suggested that this kind of radiation can cause less damage~     to normal tissue than photon radiation therapy. The physical characteristics of proton beam~     radiation let the doctor safely deliver the amount of radiation delivered to the tumor that~     is normally delivered through standard therapy but spare more normal tissue in the process.~   "
191095|NCT01063101|"~     The purpose of the study is to investigate whether orally administered BAX 513 (different~     doses administered for 5 days) affects hemostatic parameters in healthy volunteers.~   "
191096|NCT01063088|"~     The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal~     influenza vaccine with strain composition according to World Health Organization~     (WHO)/European Union (EU) recommendation for the 2009/2010 season.~   "
191097|NCT01063075|"~     The primary purpose of this study is to help answer the following research question(s):~        -  To see how the body absorbs, processes, and gets rid of cetuximab when the drug is taken~          in combination with carboplatin [pharmacokinetic (PK) analysis]~        -  To see if any drug interactions occur between cetuximab and carboplatin.~   "
191098|NCT01063062|"~     This single-arm, open-label, multicenter study evaluated the safety and tolerability and the~     efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in~     combination with methotrexate in patients with active moderate to severe rheumatoid arthritis~     (RA). Patients were eligible to participate in this study if they are currently experiencing~     an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic~     drug (DMARD). Patients received 8 mg/kg tocilizumab [RoActemra/Actemra] as an intravenous~     infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment~     was 24 weeks. The target sample size was 50-200 patients.~   "
191099|NCT01063049|"~     The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax~     combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl~     may also be used with the Gatorade and Miralax to see if it helps with the clean out process.~     We are trying to find out if either of these methods is more acceptable to the patient and~     does a better job cleaning out the colon for a colonoscopy.~   "
191100|NCT01063036|"~     The purpose of this study is to show that the combination of entecavir and tenofovir, is~     effective and well tolerated in chronic hepatitis B patients who have failed previous~     treatment.~   "
191101|NCT01063023|"~     To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and~     norelgestromin (NGMN) in healthy female subjects~   "
191102|NCT01063010|"~     The purpose of this study is to perform a pilot study to assess the potential use of~     Bevacizumab (a vascular endothelial growth factor (VEGF) inhibitor) in sepsis.~   "
191103|NCT01062997|"~     A randomized, prospective comparison of volar locked plating versus Hoffman II bridging~     external fixation supplemented by K-wire fixation in patients with comminuted distal radius~     fractures, AO/OTA type C2 & C3.~      Hypothesis:~      There is no significant difference in using volar plates compared to Hoffman II bridging~     external fixation supplemented by K-wire fixation in patients with comminuted distal radius~     fractures, AO/OTA type C2 & C3 as evaluated by a Quick-DASH score at 24 months follow-up.~   "
191104|NCT01062984|"~     Acute kidney injury is often treated with the use of continuous renal replacement therapy.~     Two commonly used treatments are continuous venvenous hemofiltration (CVVH)and continuous~     venovenous hemodialysis (CVVHD). CVVH uses convective clearance to remove toxins and solutes~     from the patients circulation, while CVVHD relies on diffusive clearance to remove these same~     toxins/solutes. This study will evaluate which of these two methods is more effective at~     clearing the body of waste/solutes.~      We hypothesize that renal replacement therapy by either modality (hemodialysis or~     hemofiltration; CVVHD or CVVH, respectively) using a modern membrane and higher blood flow~     rates will be associated with similar clearances of both small and middle molecular weight~     solutes. We further believe that continuous renal replacement therapy using CVVHD will be~     associated with decreased clotting events and longer hemofilter survival, as well as improved~     resource utilization (i.e. nursing time, alarms, etc.).~   "
191105|NCT01062971|"~     To compare intraocular pressure lowering effectiveness of a new fixed combination drug.~   "
191106|NCT01062958|"~     This study is a multi-site, retrospective chart review to determine the effect of Neevo® or~     Neevo®DHA (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb)~     levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription medical~     food indicated for the dietary management of women under a doctor's care who face high risk~     pregnancies, older overactive bladder (OB) patients and patients unable to fully metabolize~     folic acid. Data will be collected from existing patient charts of subjects administered~     Neevo® or Neevo®DHA daily compared to subjects administered a prenatal vitamin daily.~   "
191107|NCT01062945|"~     The purpose of the study is to asses the potential interactions between intravenous cocaine~     and doxazosin in cocaine dependent volunteers who are not seeking treatment. The study will~     evaluate the effects of doxazosin on the cardiovascular and subjective effects of cocaine in~     a human laboratory study.~   "
191146|NCT01062425|"~     This randomized phase II trial studies temozolomide, radiation therapy, and cediranib maleate~     to see how well they work compared with temozolomide, radiation therapy, and a placebo in~     treating patients with newly diagnosed glioblastoma (a type of brain tumor). Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses high~     energy x-rays to kill tumor cells. Cediranib maleate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~     It is not yet known whether temozolomide and radiation therapy are more effective when given~     with or without cediranib maleate in treating glioblastoma.~   "
191252|NCT01061008|"~     The purpose of this study is to investigate whether post operative progressive forearm~     exercise is effective in improving arteriovenous fistula maturation in chronic kidney disease~     patients.~   "
191108|NCT01062932|"~     Psychosocial treatments for drug abuse benefit some patients (Rawson et al 2004), but there~     is an urgent need for new treatment approaches that can improve treatment outcomes. One new~     approach involves facilitation of extinction of conditioned responses through the use of~     d-cycloserine, a partial agonist at the NMDA glycine site. This approach has proved useful~     for the treatment of several anxiety disorders. For example, treatment with d-cycloserine~     enhanced the efficacy of behavioral treatments for acrophobia (Ressler et al 2004) and social~     phobia (Hofmann et al 2006) by enhancing extinction of conditioned fear responses. This~     suggests that d-cycloserine has potential to enhance the efficacy of behavioral treatments~     for drug dependence by enhancing extinction of conditioned responses to drug cues. In this~     Phase I Cutting-Edge Basic Research Awards (CEBRA) application we propose a proof-of-concept~     study to examine effects of treatment with d-cycloserine for facilitating extinction of~     craving provoked by exposure to cigarette smoking cues. The benefits of this treatment~     approach together with cognitive behavioral treatment for reducing cigarette smoking will~     then be determined. Smoking cues will be presented using an established virtual reality~     simulator(Bordnick et al 2004; Bordnick et al 2005a)~   "
191109|NCT01062919|"~     This is a double blinded randomized controlled trial in patients undergoing colon open~     surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques~     on functional recovery after surgery.~      Twenty five patients will receive thoracic epidural analgesia plus patient controlled~     analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local~     anesthetic plus PCA (wound infusion group).~      Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion~     will be faster than patients receiving thoracic epidural analgesia.~      Functional recovery, pain intensity, opioid consumption and side effects, length of hospital~     stay and biological markers of inflammation after surgery will be measured in both groups.~   "
191110|NCT01062906|"~     Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic,~     antithrombotics and neuroprotective properties. In a previous study conducted in patients~     undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and~     fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the~     recovery room by 30%.~      The purpose of this study was to determine if an i.v. infusion of lidocaine without~     intraoperative opioids would reduce the amount of fentanyl to the same extent and~     opioids-related side effects.~   "
191111|NCT01062893|"~     An attempt is being made to see if by injecting a set volume of sterile saline into the~     epidural space during the treatment of labor pain with a combined spinal/epidural (CSE)~     increases the amount of pain relief obtained and makes the labor analgesia lasts longer.~     Subjects are in the study from the time their CSE is placed until they request additional~     pain medication from the spinal dose of numbing medicine wearing off.~   "
191112|NCT01062880|"~     Neuropattern is a first translational tool in stress medicine. Neuropattern is a diagnostic~     tool, which can be applied by in- and outpatients and physicians to detect dysregulation in~     the stress response network. The physician provides anamnestic and anthropometric data, while~     the patient takes other measures at home, e.g. psychological, symptomatic, and biological~     data. Among the biological data are ECG measures for analyses of heart rate variability, and~     salivary cortisol measures before and after a dexamethasone challenge test. All data are~     analyzed in a central laboratory, which generates a written report for the physician,~     including a disease model, from which personalized recommendations for pharmacological and~     psychological treatments are derived. Neuropattern additionally offers individualized~     internet modules to inform the patient about the disease model and to teach him/her what~     he/she can do to improve his/her medical conditions. The current study applies Neuropattern~     in 2000 patients of family doctors, suffering from major depression, depressive episodes,~     adjustment disorders, and somatoform disorders. The patients receive either unspecific or~     individualized internet modules in a randomized order.~   "
191113|NCT01062867|"~     Title: First administration to man of Org 25435, a new intravenous anaesthetic.~      Protocol: 12.4.104~      Clinical Phase: Phase I~      Study Site:~      Phase I Clinical Trials Unit Ltd Old Convent of Notre Dame 119 Looseleigh Lane Plymouth PL6~     5HH United Kingdom~      Objectives: To assess the safety, tolerability, preliminary pharmacokinetics and efficacy of~     Org 25435 as an intravenous anaesthetic.~      Study Design: Sequential study of an intravenous anaesthetic in young healthy males, at up to~     eight dose levels.~      Study Drug: Org 25435, a water soluble intravenous anaesthetic.~      Subjects: Up to 47 healthy male volunteers, aged 18-40 years.~      Evaluations: Tolerability, adverse events, EEG effects, cardiovascular effects,~     electrocardiogram (ECG), excitatory phenomena, respiratory effects, laboratory safety blood~     analyses, pharmacodynamic and pharmacokinetic measurements.~   "
191114|NCT01062854|"~     The main goal of this study is to assess whether use of earplugs has any effect on sleep,~     sleep apnea, and daytime sleepiness in individuals who snore.~   "
191115|NCT01062841|"~     This is an interventional study aimed at reducing multi-drug resistance and infections in~     nursing home (NH) residents. Each year, a staggering 1.5-2.0 million infections occur in NHs.~     Many of these infections are caused by multiple drug resistant organisms (MDROs) including~     methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE),~     and multidrug resistant Gram-negative bacilli (R-GNB). Antimicrobial resistance among common~     bacteria are adversely affecting the clinical course and exponentially increasing healthcare~     costs. Recognizing a need for action, legislators, policy makers, and consumer groups are~     advocating for pathogen-based universal preemptive screening for these MDROs, particularly~     MRSA in hospitals and NHs. However, implementing this sweeping mandate is controversial,~     costly, reactive, and not based on empirical evidence. It can result in a 10-20-fold increase~     in the number of NH residents placed in isolation precautions with the potential for reduced~     attention by healthcare workers, isolation and functional decline. The investigators proposal~     evaluates a novel focused approach between 'do nothing' and 'search all and destroy'~     strategies by targeting a subgroup of NH residents with indwelling devices who are at a high~     risk of acquiring MDROs and infections.~      The investigators hypothesize that the investigators targeted infection control program (TIP)~     will reduce MDRO colonization and infections in NH residents with indwelling devices. This~     cluster randomized trial will involve 12 NHs; 6 will be randomized to the TIP arm and 6 to~     the routine care arm. The investigators TIP intervention will include four components.~   "
191116|NCT01062828|"~     Since the first description of citrulline as a potential marker for intestinal function in~     1998, its use has been investigated in a variety of disease processes including Short Bowel~     Syndrome, Celiac disease, chemotherapy and radiation induced intestinal injury, infections~     producing intestinal cytopathic effects like Adenovirus, and predicting rejection in~     intestinal transplantation. The use of citrulline levels as a diagnostic tool to predict~     gastrointestinal disease in the premature population has not been properly addressed.~      The introduction of enteral nutrition in the premature infant is a process of trial and~     error, knowing that the immaturity of the gastrointestinal system may lead to frequent~     episodes of feeding intolerance. This is augmented by the fear of the development of~     necrotizing enterocolitis (NEC) once feeds are commenced. NEC is a condition characterized by~     disruption of the intestinal epithelial barrier, a pathogenic process shared with some of the~     conditions mentioned above for which citrulline has proven clinically useful.~      A normal pattern of citrulline production has not been established in the premature~     population. Previous studies have shown decreased levels of glutamine and arginine in~     premature infants up to 10 days prior to the development of necrotizing enterocolitis.~     Glutamine and arginine are two amino acids closely involved in the synthesis and catabolism~     of citrulline.~      The investigators therefore hypothesize that defining a normal pattern of citrulline~     production in the premature population may prove to be a clinically useful diagnostic tool to~     screen for gastrointestinal disease.~   "
191117|NCT01062815|"~     Hypothesis to be Tested:~      Since the first description of intravenous alimentation over half a century ago, parenteral~     nutrition (PN) has become a common nutritional intervention for conditions characterized by~     inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal~     Pseudoobstruction, Microvillus Inclusion Disease, Crohn's disease, multi-organ failure and~     prematurity. Parenteral Nutrition-Associated Liver Disease (PNALD) encompasses a spectrum of~     disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may~     progress to liver cirrhosis and even failure.~      There is a direct correlation between duration of parenteral nutrition and development of~     cholestasis in infants. There is evidence in animals and humans that cycling of parental~     nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces~     cholestasis. There is also data that premature infants with gestational age (GA) < 32 weeks~     and birth weight <1500g, as well as infants with congenital anomalies of the gastrointestinal~     tract, are among those at highest risk of developing Parenteral Nutrition-Associated~     Cholestasis (PNAC).~      We therefore hypothesize that infants with gestational age (GA) <32 weeks and birth weight~     (BW) between <1500g, or with congenital anomaly of the gastrointestinal tract regardless of~     GA or BW, receiving PN over a period of 20 hours will have a decrease severity of PNAC,~     demonstrated by a lower peak direct bilirubin, compared to a similar control population~     receiving standard 24 hour infusion.~   "
191118|NCT01062802|"~     Aneurysm formation is associated with a chronic inflammatory response, depletion of smooth~     muscle cell population and excessive matrix metalloproteinases (MMPs) production.~     3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) are lipid~     lowering agents with pleiotropic effects including anti-inflammatory activity. Elective open~     AAA repair patients will be randomised to receive either statin (Atorvastatin 80 mg) or~     placebo (dummy tablet) for 4 weeks pre-operatively. Tissue samples will be obtained from~     patient's aneurysm to assess MMP's and their inhibitors TIMP's. It is hypothesized that~     patients receiving statin will have reduced MMP's.~   "
191119|NCT01062789|"~     The objective or our study is to test the feasibility of a new optical-based breath-hold~     control (OBC) system for monitoring breath-hold levels and providing patient feedback during~     CT-guided biopsies of the lung and upper abdomen where respiratory motion is a problem.~   "
191120|NCT01062776|"~     1. The distribution and elimination of infusion fluids can be studied by volume kinetics, a~          mathematical method based on serial analysis of the blood hemoglobin concentration.~        2. The hypothesis of the present study is that the elimination of infused fluid is retarded~          in the presence of dehydration, and that volume kinetics would therefore be capable of~          detecting dehydration in human subjects.~        3. We induce dehydration by injection graded doses of furosemide (a diuretic drug) in~          healthy volunteers and the kinetics of an infusion of crystalloid fluid is compared to~          when the same volunteer receives the same fluid without being in a dehydrated state.~   "
191121|NCT01062763|"~     The purpose of this study is to estimate the effect of spironolactone on blood pressure~     resistant to therapy in type-2 diabetics.~   "
191122|NCT01062750|"~     Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful~     for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell~     compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive~     autologous adipose tissue derived stromal cells through intrahepatic arterial~     catheterization.~   "
191123|NCT01062737|"~     This study aims to assess the long term (three years) ability of ASU (Avocado Soya~     unsaponifiable) to slow the decrease of radiographic JSW (Joint Space Width) in hip~     osteoarthritis (OA). This is a randomized, double blind, comparative, parallel group study~     versus placebo.~   "
191124|NCT01062724|"~     The purpose of this study is to analyze if the infants who received Primene solution, have~     lower serum levels of methionine and cysteine and higher serum levels of taurine, we also~     analyze if the infants who received Primene solution develop TPN-associated cholestasis in a~     smaller proportion than those who received Trophamine solution.~   "
191147|NCT01062399|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as temozolomide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Radiation therapy uses high energy~     x-rays to kill tumor cells. Giving everolimus together with temozolomide and radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when~     given together with temozolomide and radiation therapy and to see how well it works in~     treating patients with newly diagnosed glioblastoma multiforme.~   "
191264|NCT01060852|"~     The purpose of this study was to determine whether a media literacy education program taught~     be teacher to late elementary school students (grades 3-5) positively affected students'~     critical thinking skills and substance use-related health outcomes.~   "
191125|NCT01062711|"~     When we age, we lose muscle. It is not exactly clear why this happens, but we do know that~     this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e.~     performing resistance exercise) and proper nutrition, in particular eating enough high~     quality protein, can help slow the loss of muscle mass or potentially even reverse it.~     Protein and resistance exercise are thought to do this by stimulating your muscle to make~     more proteins and/or potentially by slowing down the rate at which your body breaks proteins~     down. Whey protein is a high quality protein isolated from milk and is known to stimulate new~     protein synthesis for all proteins in your body. However, to date, the effect that whey~     protein has on muscle protein synthesis, particularly in the elderly has yet to be~     determined. Thus the purposes of this study are: 1) to determine if whey is an effective~     source of protein that will stimulate muscle protein synthesis in the elderly, similar to~     what we have previously seen in young persons; 2) to determine the smallest amount of whey~     protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if~     performing resistance exercise will augment the increase in new muscle protein synthesis with~     whey consumption; and 4) to try and found out if whey is more effective than soy protein in~     stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the~     elderly, similar to what we have previously seen in young persons~   "
191126|NCT01062698|"~     THRACE is a controled, multicenter and randomized trial.~      The primary objective of this study is to determine whether a combined approach intravenous~     thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV~     thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of~     proximal cerebral arteries and with a neurological impairment accident (National Institutes~     of Health Stroke Scale [NIHSS] ≥ 10).~      The second objective is to determine the cost-effectiveness of this procedure compared to the~     standard (IV thrombolysis). The assumption is that the combined approach, by improving the~     clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in~     3 months and less than or at worst neutral to 1 year.~   "
191127|NCT01062685|"~     The overall hypotheses of this project is that Near Infrared Spectroscopy (NIRS) can be used~     to identify morbidity, mortality, and resource utilization in patients with sepsis and septic~     shock.~   "
191128|NCT01062672|"~     The study's objective is to measure changes in human visual cortex organization that may~     arise as a result of injury to the visual pathways. Subjects with retinal or cortical injury~     will be studied and compared to appropriate controls. Functional magnetic resonance imaging~     methods are used to monitor cortical topography in time. The main aims of the study are to~     determine: 1) what are the patterns of cortical reorganization that are seen spontaneously~     after injury, and 2) whether rehabilitative training can promote adaptive reorganization~     enhancing recovery.~   "
191129|NCT01062659|"~     In order to persist in the liver, HCV has numerous nonspecific and specific strategies to~     overcome the immunity of the host. The crucial step in the establishment of viral persistence~     and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the~     liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV)~     is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy~     depends on the effective cellular antiviral immune response in the liver. The understanding~     of the interaction between HCV and cellular immune response is important for the effective~     use of existing diagnostic techniques, the Individual control and adjustment of the current~     therapeutic approaches and the development of future therapeutic and immunization strategies.~     In this study, the investigators want to investigate cellular Immune responses in the liver~     of HCV infected patients and characterize the influence of these immune responses to the~     response to IFNα / RBV therapy.~   "
191130|NCT01062646|"~     Multimodal music therapy (MT) for children ages 8 to 12 years with anxiety disorders is~     compared to community treatment as usual (TAU). 36 children were randomized either to MT or~     to TAU. Primary outcome is presence of an anxiety disorder at the end of treatment. Secondary~     outcomes are self- and parent-/teacher reported anxiety, co-morbid psychological symptoms,~     and quality of life. Stability of outcome is assessed six months after the end of treatment.~   "
191131|NCT01062633|"~     This study aims at demonstrating the effect of erythritol and xylitol lozenges on preventing~     the new caries lesions and the possible remineralization effect of both polyols on incipient~     caries lesions.~   "
191132|NCT01062620|"~     A dose escalating phase Ia-b clinical trial of the IGF-1 receptor inhibitor AXL1717 in~     patients with advanced cancer.~      The objective is to study the safety and pharmacokinetics of AXL1717 and to define an~     appropriate Phase 2 dose for further studies. This is the first study in man. The study is~     not designed to show tumor response.~   "
191133|NCT01062607|"~     This study is to provide reliable information on the management of bipolar disorders in real~     every day, clinical practice, to determine the clinical outcomes of such management and use~     of resources in relation to the disease, and to establish the factors associated with~     different management patterns and clinical outcomes.~   "
191143|NCT01062477|"~     The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined~     vaccine in support of registration of this product in China~      Primary Objectives:~        -  To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4~          and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria,~          Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine~          given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP)~          antigens, one month after the three-dose primary vaccination.~        -  To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine~          administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis~          Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with~          Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose~          primary vaccination.~      Secondary Objectives:~        -  To describe the safety after administration of the study vaccines.~        -  To describe in each group the immunogenicity of the study vaccines one month after the~          primary vaccination and before and one month after the booster vaccination.~   "
191556|NCT01057017|"~     Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease~     progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease~     progression.Primary Objective: To determine the safety of every 3 week panitumumab and~     bevacizumab as maintenance therapy for patients with metastatic colorectal cancer.~   "
191134|NCT01062594|"~     An aneurysm is a permanent and localized dilatation of an artery usually more than 50% of its~     normal diameter. Abdominal Aortic Aneurysms (AAA) is an aneurysm of the main artery of~     abdomen and affects 5% of men aged 65-74 years. Rupture of an aneurysm is the 10th leading~     cause of death in white men over 65 years of age in industrial countries. Treatment of~     asymptomatic AAA is considered when the diameter of an AAA reaches 5.5 cm. There are two~     treatment options available: conventional open surgical repair or endovascular repair, which~     is a less invasive mode of treatment. After the operation heart and lung complications are~     significant in patients undergoing major abdominal surgery. The commonest causes of death are~     due to heart problems. There are various studies which have shown benefits of pre operative~     exercise training in patients undergoing orthopaedic, lung and heart bypass surgery.~     Currently, there is no data available with regards to the effect of pre-operative (before~     operation) supervised exercise in patients undergoing surgery for an AAA.~      The main aim of this study will be to determine whether a pre-operative supervised exercise~     programme improves post-operative (after operation) outcome, compared to standard treatment.~      Patients will be entered in the study once a decision to repair their AAA has been made by~     the consultant. They will undergo pre-operative assessment and will be divided randomly into~     two groups. One group will have exercise training for 4-6 weeks before surgery and the other~     will not. After the operation they will be followed during the post-operative period to~     determine the presence or absence of complications. It is anticipated that complications will~     be less in the group which has undertaken exercise training before operation.~   "
191135|NCT01062581|"~     Under Transplant Information Services (TIS), the University of Minnesota Transplant Registry~     (UMTR) will serve as the repository for core research data.~   "
191136|NCT01062568|"~     In girls with elevated androgens the precise source of androgen excess throughout puberty and~     early adolescence has not been carefully examined. The investigators propose to examine~     whether the adrenal gland produces the majority of androgens during puberty by studying the~     differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in~     normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare~     steroid changes before, 30 min, and 60 min after ACTH administration in NW and OB girls.~   "
191137|NCT01062555|"~     Reducing drug side effects is a key issue in transplantation. One class of drugs commonly~     used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely,~     toxicity to the transplanted kidney. In some patients, this toxicity is thought to be~     associated with loss of transplant function in those who have had their transplants for many~     years. The introduction of new immunosuppression medications however, has provided the~     opportunity to minimize or avoid CNIs, which may reduce the occurrence of toxicity to the~     kidney.~   "
191138|NCT01062542|"~     Chemotherapy can damage the ovaries and cause premature menopause. In women treated before~     the age of 40 years, menopause does not usually occur. We have very little information about~     the impact of chemotherapy on ovarian function in this particular group of women. In this~     study, we will check hormone blood tests and ultrasound tests of the ovaries to measure the~     reserve of eggs left in the ovaries after treatment in young survivors of breast cancer and~     childhood cancer. We will do the same tests in our comparison group. We can use these results~     to estimate the reduction in fertility in young cancer survivors.~   "
191139|NCT01062529|"~     The aim of this study is to investigate peripheral effects of Somatostatin on glucose~     metabolism and growth hormone (GH) signalling in healthy men. Eight subjects will be~     enrolled. The hypothesis is that Somatostatin infusion reverses insulin resistance caused by~     GH.~   "
191140|NCT01062516|"~     The investigators examine the influence of esomeprazole versus famotidine on antiplatelet~     action of clopidogrel associated with aspirin. At least 100 consecutive patients suffering~     from acute coronary syndrome or undergoing coronary artery stent implantation , who received~     aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day or~     75mg/day for at least 7 consecutive days), are randomised to receive either esomeprazole 20~     mg daily vs famotidine 40 mg daily in a double blinded manner. Clopidogrel effect was tested~     by measuring residual platelet reactivity (RPR) to ADP by VerifyNow P2Y12 assay (Accumetrics~     Inc, San Diego, Calif). At baseline, whole blood will be obtained for RPR at least 12 h after~     clopidogrel loading dose or at least 7 days of maintaince dose. Immediately obtaining the~     baseline blood, patients will be randomized to receive either esomeprazole (20 mg/day) or~     famotidine 40 mg/day for 28 days. Double blinding will be performed by encapsulation of study~     drugs. RPR will be measured again at the 28th day.~      The investigators will compare the % inhibition and the P2Y12 reaction Units (PRU) at the~     28-day treatment period in the 2 groups.~   "
191141|NCT01062503|"~     Bone is the most common site of metastases in prostate cancer and bone complications cause~     substantial morbidity to this population. Phase III studies have shown that zoledronic acid~     is effective in decreasing the morbidity associated with bone metastases. Zoledronic acid~     (ZA) is generally well tolerated but may have side effects such as hypocalcemia, renal~     impairment and osteonecrosis of the jaw. Administration of ZA as infrequently as once yearly~     is sufficient to prevent osteopenia or osteoporosis. The optimal treatment interval is~     unknown, but the drug is often empirically administered every 3-4 weeks. The cost of such~     treatment is high, and the risk of exposing patients (especially those at low risk) to~     potential serious side effects with uncertain benefit warrants investigation. This study will~     determine the duration of suppression of bone turnover in prostate cancer patients with bone~     metastases following a single infusion of Zoledronic Acid and its effect on quality of life.~   "
191142|NCT01062490|"~     This is a multicenter, multinational, non-randomized, non-controlled open-label phase II~     trial to evaluate the safety and efficacy of treosulfan in a combination regimen with~     fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in~     patients with MDS.~      The aim is to demonstrate a clinical benefit compared to historical data with intravenous~     busulfan.~   "
191144|NCT01062451|"~     The primary objective is to determine the dose dependent effects of treatment with~     perindopril on methamphetamine (MA)-induced craving and on the reinforcing effects of MA~     indexed by MA self-administration. We will also determine the effects of treatment with~     candesartan on MA-induced craving and on the reinforcing effects of MA indexed by MA~     self-administration.~   "
191148|NCT01062386|"~     Malaria is one of the major public health problems in Sub-Saharan Africa. In response to this~     threat, Roll Back Malaria (RBM) has rolled back a strategy using ACT as first line therapy~     for malaria episode, a wide distribution of Insecticide Treated Bednet (ITN), intermittent~     presumptive treatment of pregnant women and indoor residual spraying. Recent epidemiological~     observations suggested a decline in malaria prevalence in some countries but further~     evidences are still needed to confirm this evolution. The RBM strategy requires the use of~     reliable rapid diagnostic test (RDT) for which an operational assessment is necessary.~     Lastly, home-based management of malaria is also an important compound of this strategy.~     However, a better understanding of the actual use of antimalarial drugs, of the use of bednet~     and of the barrier to the use of health care is important to implement good quality~     strategies for malaria control.~      This study is a cross-sectional community based survey made of two rounds (one in January~     2010 and the second in June 2010). The general objective is to measure the prevalence of~     infection with Plasmodium falciparum at two periods of the year (at the moment of lowest and~     highest transmission based on the seasonal rainfalls) and to compare it with the prevalence~     estimated in 2004 after the rainy season for the same area. Specific objective are the~     estimation of the prevalence by age stratum, the analysis of the geographical distribution of~     the infection, the description of the parasitological characteristics, the assessment of~     three RDT, the description and the analysis of the prevention and care seek behaviours~     related to malaria.~      The study area is the great Mbarara district located in south-west of Uganda. A three-stage~     cluster sampling method will be used. Spatial information will be collected with global~     positioning system and imported to Geographical Information System. Behaviour information~     will be collected through face to face interview.~   "
191149|NCT01062373|"~     Several recent publications showed a reduction in the level of DHA and/or an increase in the~     arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the~     polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is~     unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas~     scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human~     milk to explain the beneficial role of the breast-feeding at short, medium and long term. We~     will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status~     improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA~     ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and~     n-6 fatty acids pathways.~   "
191150|NCT01062360|"~     The purpose of this study is compare efficacy and tolerability of a fixed combination,~     containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single~     components in patients with sore throat and nasal congestion.~   "
191151|NCT01062347|"~     Zinc deficiency is a widespread public health problem in developing countries. The true~     prevalence of this condition remains uncertain because of lack of a specific, sensitive and~     reliable biomarker for assessment of human zinc status. The most widely used indicator for~     measuring zinc status is serum zinc level, which, however, is homeostatically regulated and~     influenced by stress and infection. To explore the possibility of using mRNA levels of zinc~     responsive genes as an indicator of zinc status, Cao and Cousins suggested metallothionein~     (MT) mRNA level in monocytes and peripheral blood mononuclear cells as an indicator of recent~     zinc uptake. However, the usefulness of MT mRNA is also limited because its level is~     influenced by other metals, such as copper, cadmium and cobalt and it is also affected by~     stress. Several authors have proposed that expression of zinc transporter genes might be~     useful markers of Zn status. Evidence shows reduction in dietary zinc content produces a~     marked increase in intestinal absorption and decrease in intestinal zinc losses. As zinc~     homeostasis is regulated in the intestine, study of the zinc transporters in this organ may~     provide indication of recent zinc uptake. Recently, a few studies have begun to investigate~     the applicability of using white blood cell zinc transporter expression as an indicator of~     zinc status and found that some of the transporters are zinc responsive. The primary~     objective of this study is to explore whether the expression of zinc responsive genes, such~     as zinc transporters in human intestinal mucosal cells, can be used as indicators of zinc~     status. The specific aims are to compare gene expression in: a) intestinal mucosal cells~     obtained by duodenal biopsy, b) sloughed intestinal mucosal cells isolated from feces, and c)~     peripheral blood mononuclear cells (PBMC) in fasting individuals who are receiving their~     usual diet + placebo or their usual diet + supplemental zinc (20 mg/d for 7 days). Gene~     expression values from intestinal mucosal cells (biopsy) will be compared between the placebo~     and zinc supplemented groups. Similar comparison will be done in the cells isolated from~     stool and PBMCs. This study will also provide an opportunity to compare the relative~     responsiveness of gene expression and serum zinc concentration following supplementation and~     to explore the kinetics of any changes in serum zinc concentration. Thus, blood samples will~     be obtained for measuring serum zinc concentration on two occasions prior to the~     interventions and at specified intervals during and after the intervention.~   "
191152|NCT01062334|"~     Anastomotic leakage is a serious complication after LAR with high morbidity and mortality~     rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to~     investigate the clinical use of peritoneal microdialysis and whether is able to detect~     anastomotic leakage prior to clinical symptoms.~   "
191153|NCT01062321|"~     Hepatitis E virus is a public health problem in several countries of the world where safe~     drinking water is a problem. HEV is an exclusive cause of epidemic hepatitis in general~     population. HEV infection occurs most frequently in rainy season. The disease affects mainly~     young adults in the age of 15-40 years.HEV viral infection is of particular concern in~     pregnancy. It is a potential disaster for mother and child. HEV infection during pregnancy is~     fulminant and fatal especially if it occurs in third trimester. The mortality in the second~     trimester is around 20% and reaches upto 45% in the third trimester.~   "
191154|NCT01062308|"~     Background and Rationale: The most commonly seen disabilities in stroke patients are shoulder~     injuries such as shoulder pain, glenohumeral subluxation, spasticity of shoulder muscles,~     soft-tissue trauma, rotator cuff tears, and shoulder-hand syndrome.~      Taping is widely used in the field of rehabilitation as both means of treatment and~     prevention of sports related injuries. Scarce information is available regarding the use of~     shoulder taping in preventing shoulder injuries in stroke patients. Aims:~      To find out the effectiveness of taping technique with conventional treatment versus sham~     taping and conventional treatment in prevention of shoulder injuries in patients with acute~     stroke.~      Hypothesis:~      Taping technique with conventional treatment will be superior to conventional treatment alone~     in preventing shoulder injuries in patients with acute stroke.~      Methods Research setting: Stroke unit, department of Neurology, Christian Medical College~     (CMC) Ludhiana, Punjab, India and College of Physiotherapy, CMC Ludhiana.~      Study design: prospective, randomized, outcome blinded trial (PROBE design). Study period:~     Prospective for 18 months from May 2009 All stroke patients with upper limb weakness within~     48 hours after the ictus and with Brunnstrom's stage of recovery 1 and 2 will be included in~     the study. Patients will be randomized into two groups using lottery method. The treatment~     arm group(Group I) include shoulder taping with conventional techniques that is(positioning,~     handling technique and passive range of motion exercises) and the control arm (Group II)~     include sham taping with conventional techniques with sham taping. A total of 80 patients in~     each group will be included. The plastic micropore and elastic adhesive tape will be used for~     taping the affected shoulder. The sham taping will be done using the same tapes but without~     stretching the concerned muscles and joints. The tapes will be changed every 3 days and will~     remain for 14 days. The outcome measures are as follows; Primary: Pain: Visual Analog Scale~     and Activities of daily living: Shoulder Pain and Disability Index (SPADI); Secondary: Range~     of motion: using a Goniometer. The outcome will be assessed by an independent physiotherapist~     who will be blinded to the clinical details. Patients will be followed-up at 14 days and 30~     days. Statistical analyses will be done using SPSS software version 16.~   "
191181|NCT01061944|"~     In this research study, we are looking at performing a repeat biopsy of patients' tumors,~     even though they have already been diagnosed with cancer. The tumor tissue obtained from the~     biopsy will be studied to see what it looks like at the molecular (genetic) level. By~     conducting this study, we hope to learn more about how cancers work, why cancers respond to~     certain treatments, and how they become resistant to certain treatments. We also hope to~     demonstrate that biopsies like this can be performed safely in large numbers of patients. The~     research done on the tumor samples may help us identify which patients in the future are most~     likely to respond to new cancer therapies.~   "
191155|NCT01062295|"~     NTRODUCTION: The investigators have developed a new device to help passengers of vehicles to~     rest, sleep, and to avoid cervical injuries due to sleepiness postures while travelling. The~     device is attached to the headrest and is based in a new concept called dynamic vertical~     holding of the head and neck. It could also provide some help in avoiding accidents by~     allowing a sleeping time for a secondary driver while the main one is driving. Several~     studies have shown that up to 30% of car crashes are related to sleepiness.~      AIM: To estimate the efficacy and safety of a new device in patent pending phase to~     facilitate the sleep and rest in the passenger.~      METODOLOGY: DESIGN: Prospective, cross-over and open clinical assay, comparing the results of~     40 different passengers during a journey after using both systems, that is the new device and~     the standard headrest.~      MEASUREMENTS: A) Standard polysomnography for 3 and a half hours during the night; B)~     Anthropometric and clinical variables; C) Sleepiness scale and Epworth sleepiness; D)~     Questionnaires of sleep, health and quality of life. E) Evaluation of the neck posture in~     recorded images.~      ANALYSIS: To compare the results of questionnaires of sleep quality, comfort and safety as~     well as the images recorded and polysomnographic variables of objective sleep variables~     obtained by the device Siesta-SystemTM and the conventional headrest.~   "
191156|NCT01062282|"~     The purpose of this study is to gain information on safety and efficacy from Korean patients~     who starting Ventavis treatment by observational method.~   "
191157|NCT01062269|"~     The purpose of the research study is (1) to rate the taste, texture, appearance, and~     mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored~     Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating~     cholestyramine and Tang to determine the accuracy and usefulness of a taste test~     questionnaire.~   "
191158|NCT01062256|"~     The objectives of this study are: a) to assess the feasibility and sensitivity of manually~     count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and~     guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and~     severity of acute cough due to upper respiratory tract infection and c) to evaluate the~     correlation between cough bout frequency and subjective assessments of cough severity. The~     hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release~     guaifenesin will significantly reduce the frequency and severity of cough compared to placebo~     over a 4-hour evaluation period.~   "
191159|NCT01062243|"~     The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS) is a comprehensive~     intervention to meet the needs of family members and significant others of patients who are~     undergoing acute, inpatient brain injury rehabilitation.~   "
191160|NCT01062230|"~     The primary aim of this trial is to determine the effect of a short course (i.e., 3 cycles)~     of low-dose Bortezomib (Velcade) on bone remodeling and on disease progression. The dose of~     bortezomib used in this trial of 0.7 mg/m2 is the lowest dose which has shown efficacy in the~     3 largest monotherapy trials with bortezomib. 17% of patients in the APEX, 9% patients in~     CREST and 24% in SUMMIT trials were treated with 0.7 mg/m2 dosages. Bortezomib will be given~     on days 1, 8, 15, 22 over 42 days to reduce the incidence of possible drug related side~     effects.~      OBJECTIVES:~      Primary Objective~      The primary objective of this study is to:~        -  To evaluate the effect of Velcade at 0.7 mg/m2 dose on inducing osteoblast activation as~          measured by ALP and other bone markers in patients with relapsed/refractory myeloma.~      Secondary Objectives~      The secondary objectives of this study are to:~        -  To evaluate the association between osteoblastic activation and myeloma response to~          Velcade.~        -  To identify predictive factors for Velcade-associated osteoblastic activation.~   "
191161|NCT01062204|"~     The primary objective of the study is to evaluate the time to wound healing in skin graft~     donor sites with a new treatment (Altrazeal dressing) compared to standard of care treatment~     (Aquacel Ag- Carboxymethylcellulose dressing) in partial thickness skin graft donor sites.~   "
191162|NCT01062191|"~     The objective of this study is to evaluate the difference in joint range of motion of a new~     flexible hydrogel nanoparticle wound dressing compared to typical sodium~     carboxymethylcellulose dressing Aquacel AG for treatment of partial thickness burns.~   "
191163|NCT01062178|"~     Patients with an incidentally discovered small renal masses (SRM) < 4 cm in diameter are~     included. All patients will undergo biopsy for tissue diagnosis. Most patients will be~     followed by imaging. Study intervention includes low MI US to be performed following both~     bolus and infusion injection of Definity contrast. Presence and absence of vascularity,~     pattern of vascularity, and TIC values will be correlated with the final pathology to find~     features differentiating benign from malignant masses.~   "
191164|NCT01062165|"~     This study will find how weight affects the dosing of a drug called caspofungin. Currently,~     the amount of caspofungin a patient receives is the same regardless of the patient's weight.~   "
191165|NCT01062152|"~     This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of~     ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate~     1 risk MDS. The HI-E, HI-N, HI-P rates [by International Working Group (IWG) 2006 criteria]~     and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat~     in combination with lenalidomide for future studies.~   "
191166|NCT01062139|"~     Title of Study:~      A randomized, parallel, double-blind, multi-center, comparative study to evaluate the~     efficacy and safety of Cosalin monotherapy versus Cosalin and Xarlin combination therapy in~     patients with allergic rhinitis~      Objective of study:~      To exploratively evaluate superiority of combination therapy - twice-daily Cosalin Tab~     (Petasites hybridus CO2 extract) with once-daily Xarlin Tab (Levocetirizine HCl) - compared~     to monotherapy of Cosalin with allergic rhinitis subjects.~   "
191182|NCT01061931|"~     The purpose of this prospective randomized single-center trial is to compare efficiency and~     safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial~     fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.~   "
191183|NCT01061918|"~     The purpose of this study is to compare the visual outcomes with bilateral implantation of~     Tecnis MF and ReSTOR intraocular lenses (IOLs) 6 months post cataract surgery.~   "
191598|NCT01056471|"~     The main purpose of this study is to evaluate the safety and feasibility of regenerative~     therapy with mesenchymal stem cells from adipose tissue, administered intravenously in~     patients with secondary progressive multiple sclerosis who do not respond to treatment.~   "
191167|NCT01062126|"~     Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have~     been made in pacemaker therapy, diagnostics and connectivity. These advancements include~     automated capture, automated sensing, patient alert functions, algorithms minimizing~     ventricular pacing, automatic mode switching in response to atrial tachyarrhythmia, rate~     responsive pacing, advanced diagnostic features, remote monitoring and radiofrequency (RF)~     technology. However, little information is available on how these new features are being~     utilized by physicians in the real world and how these features impact patient outcomes.~      This observational study will gather data on the patients' presenting clinical status,~     indication for device implantation, utilization of advanced device features, device therapy~     choices, clinical management and outcomes in a general pacemaker population.~      The primary aim of the study is to evaluate the usage of advanced features and diagnostics in~     patients with St. Jude Medical pacemakers. The secondary aim of the study is to learn more~     about the progressive clinical outcomes in the general pacemaker patient population. The~     tertiary aim of the study is to evaluate the correlation between the usage of advanced~     features in pacemaker patients and the patient's clinical outcomes.~   "
191168|NCT01062113|"~     To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in~     patients with post lateral mandibular impacted third molar tooth extraction pain.~   "
191169|NCT01062100|"~     To evaluate the feasibility, acceptability and safety of using a molecular breast imaging~     (MBI) Gamma Camera in women at high risk of developing breast cancer~   "
191170|NCT01062087|"~     The purpose of this study is to attempt to determine retrospectively whether there was a~     statistically significant difference in patient need for postoperative narcotics between two~     different groups of women who received a laparoscopic tubal ligation. One group received a~     local anesthetic injection or gel at the surgical sites, in addition to general anesthesia.~     The other group did not receive any local anesthetic but did receive general anesthesia. The~     investigators hypothesize that the group that received the local anesthetic injection or gel~     had lower average postoperative narcotic requirements and shorter postoperative dismissal to~     home times than the group that did not receive the auxiliary local anesthetic.~   "
191171|NCT01062074|"~     This survey is conducted for preparing application materials for re-examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the~     clinical usefulness of Gardasil through collecting the safety information according to the~     Re-examination Regulation for New Drugs.~   "
191172|NCT01062061|"~     This survey is conducted for preparing application materials for re-examination under the~     Korean Pharmaceutical Affairs Laws and its Enforcement Regulation; its aim is to reconfirm~     the clinical usefulness of VARIVAX through collecting the safety information according to the~     Re-examination Regulation for New Drugs.~   "
191173|NCT01062048|"~     The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in~     Korean participants, and 2) To identify factors that might have an influence on the safety~     and efficacy profile of Januvia in Korean participants.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
191174|NCT01062035|"~     The aim of this study is to develop a blood test to determine which patients are at risk for~     pre-cancerous colon polyps (ACPs: Advanced Colon Polyps). The telomere length of peripheral~     blood lymphocytes (PBLs) can be measured from a blood sample. Mechanistic pathways and the~     investigator's preliminary data support PBL telomere length as a biomarker for ACPs. The~     long-term goal of this project is to decrease deaths from colon cancer by using a blood test~     to target colonoscopy for those patients who are at high risk for pre-cancerous polyps.~   "
191175|NCT01062022|"~     The purpose of this study is to implement a unique evidence-based intervention program to~     help military families deal with the critical issue of combat injury and its impact on~     current and future family health and functioning. The study is a randomized study. The study~     will compare the effects of the newly designed FOCUS-CI (Families OverComing Under Stress -~     Combat Injury) with the existing standard of care (SoC) at three military medical~     rehabilitation sites (Walter Reed Amry Medical Center, Brooke Army Medical Center and Madigan~     Army Medical Center) on key aspects of family health and functioning.~   "
191176|NCT01062009|"~     The purpose of the study is 1) to determine whether administration of intravenous zinc to~     critically ill children is safe, and 2) to determine an appropriate dose of zinc~     supplementation.~   "
191177|NCT01061996|"~     Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in~     subjects with ulcerative colitis who completed previous basiliximab studies.~      Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this~     multiple-dose maintenance regimen in this population~   "
191178|NCT01061983|"~     This study will evaluate the safety and effectiveness of deep brain stimulation in treating~     people with severe and otherwise treatment-resistant obsessive-compulsive disorder. We also~     expect to determine how DBS affects brain activity in brain circuits strongly implicated in~     OCD, and how such effects may relate to symptom change. This treatment study therefore also~     permits a unique and crucial test of current neuroanatomical models of both OCD pathogenesis~     and mechanisms underlying the response to treatment.~   "
191179|NCT01061970|"~     The objective of the study is to assess and compare the preliminary efficacy, safety and~     tolerability of fispemifene 300 mg and placebo given once daily for 4 weeks in the treatment~     of hypogonadal men with chronic obstructive pulmonary disease (COPD) that are on oral~     glucocorticoid therapy.~   "
191180|NCT01061957|"~     Raltegravir is the first integrase inhibitor approved for treatment of HIV infected patients~     harboring multiresistant viruses. The drug has been proved effective in both trials and~     clinical settings, but the long-term efficacy is not described and the effect compared to~     treatment in Highly active antiretroviral therapy (HAART) naive patients remains to be~     established.~   "
191195|NCT01061749|"~     This phase I clinical trial studies the safety and best dose of selumetinib and cixutumumab~     in treating patients with advanced solid malignancies. Selumetinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as cixutumumab, can block tumor growth in different ways. Some block the ability of~     tumor to grow and spread. Others find tumor cells and help kill them or carry~     [cancer/tumor]-killing substances to them.~   "
191184|NCT01061905|"~     This is the second in a series of pilot interventions we are conducting to assess how~     principles from behavioral economics can be applied to improve consumers' food choices. In~     collaboration with Aramark, the food service vendor, we intend to examine if calorie labeling~     in different formats impacts consumers choice of bottled beverages in hospital cafeterias.~     Specifically, we will be testing whether signage that conveys to consumers the number of~     calories in each bottled beverage will increase the number of zero-calorie beverages sold~     relative to non-zero-calorie beverages. Likewise, we will test whether signage that conveys~     calories in exercise equivalents increases the sale of zero-calorie beverages. Lastly, we~     will test if signage conveying standard calorie information in conjunction with exercise~     equivalents increases the sale of zero-calorie beverages. We will measure the differential~     effect of each of these three formats for calorie information.~   "
191185|NCT01061879|"~     By doing this study, researchers hope to develop a special technique and laboratory~     conditions to help support umbilical stem cell growth and multiplication.~      In this project, researchers propose a three dimensional (3D) microenvironment that mimics~     the bone marrow stem cell microenvironment, with its supporting cells of osteoblasts and~     stromal cells. In theory, this will result in better expansion of cord blood stem cells ex~     vivo.~   "
191186|NCT01061866|"~     The purpose of this study is to determine whether thalidomide is effective in the refractory~     epilepsy treatment.~   "
191187|NCT01061853|"~     The purpose of this study is to determine wether topical rapamycin is more efficient than~     topical steroids in the treatment of chronic erosive lichen planus.~   "
191188|NCT01061840|"~     Autologous Vigil™ vaccine expresses rhGMCSF and bi-shRNAfurin from the Vigil™ plasmid. The~     GMCSF protein is a potent stimulator of the immune system, recruiting immune effectors to the~     site of intradermal injection and promoting antigen presentation. The furin bifunctional~     shRNA blocks furin protein production at the post transcriptional and translational levels.~     This decrease in furin in turn decreases the conversion of the proforms TGFβ1 and TGFβ2~     proteins. Also, reduced furin protein levels have a negative feedback inhibition on TGFβ1 and~     TGFβ2 gene expression, decreasing the levels of their mRNAs. The resulting decrease in TGFβ1~     and TGFβ2 proteins reduces the local immunosuppression they cause and promotes tumor surface~     antigen and MHC protein display.~   "
191189|NCT01061827|"~     A major public health issues of today's aging population is the development of knowledge and~     expertise in geriatric medicine and psychiatry of the elderly. The depressive disorders and~     dementia, are among the psychiatric conditions most common in older age. They are the subject~     of much clinical research, in which brain imaging techniques used to establish correlations~     anatomo-clinical and radiological-clinical. The prerequisite for the realization of such work~     locally, is the validation in their French version of clinical assessment tools most commonly~     used internationally, ensuring reliability, acceptability and comparability of results. Among~     these tools, Geriatric Mental Schedule (GMS) Package, is the reference tool for research in~     psychiatry of the elderly. It is a standardized and structured questionnaire that allows to~     establish with reliability and reproducibility on the basis of answers to questions, major~     psychiatric diagnoses in the elderly. It has been validated in several languages (German,~     Spanish, Italian, Dutch, but also Chinese, Korean ...), but is still not available in French.~      Hypothesis: Validate the the French version of Geriatric Mental Schedule (GMS) Package, to~     establish diagnoses of dementia and depressive disorders.~   "
191190|NCT01061814|"~     Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL).~     Elevated LDL is a major risk factor for coronary heart disease (CHD). Mipomersen is an~     antisense drug that reduces a protein in the liver cells called apolipoprotein B-100~     (apoB-100). ApoB-100 plays a role in producing low density lipoprotein cholesterol (LDL-C)~     (the 'bad' cholesterol) and moving it from the liver to one's bloodstream. High LDL-C is an~     independent risk factor for the development of coronary heart disease (CHD) or other diseases~     of blood vessels. It has been shown that lowering LDL-C reduces the risk of heart attacks and~     other major adverse cardiovascular events.~      Mipomersen is an investigational product being studied to determine if it is safe and~     effective in lowering LDL-C in specific populations of patients with hypercholesterolemia.~      This phase 1 study is being conducted to evaluate 3 different dosing regimens (daily, 3 times~     per week, or weekly) in healthy volunteers for a total of 3 weeks of dosing. Study procedures~     will include blood testing and physical examinations to assess the safety and tolerability of~     the different regimens. Tests will also be done to determine how much of the drug is present~     in the circulation (blood flow in the body). Specific pharmacokinetic (PK) tests on the blood~     samples will determine what the body does to the investigational product after it is~     injected, including how it is absorbed, distributed, the rate at which drug action begins and~     the duration of the effect.~      Eligible subjects will receive study injections of either mipomersen or placebo over a 3 week~     period followed by a 12 week safety follow-up period.~   "
191191|NCT01061801|"~     This study seeks to test a brief psychological intervention for spousal caregivers of cancer~     patients (specifically, hematopoietic stem cell transplant patients), persons known to~     experience emotional distress.~   "
191192|NCT01061788|"~     This open-label, non-randomized, dose escalation phase I biomarker trial of the triplet~     regimen of AMG 479, everolimus, and panitumumab for subjects with refractory advanced solid~     tumors is designed to assess the safety and tolerability of this combination as well as~     preliminary efficacy.~   "
191193|NCT01061775|"~     The primary aim of this study is to evaluate the effect of Exenatide on weight status (change~     in body mass index) of children treated for craniopharyngioma that have developed~     hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that~     Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index~     significantly from baseline.~   "
191194|NCT01061762|"~     Consistent adherence to antiretroviral therapy is necessary for treatment success. People~     with poor health literacy skills experience considerable difficulty adhering to their~     medications. Effective strategies for improving adherence in patients with poor health~     literacy must be tailored to achieve optimal adherence and therefore viral suppression. This~     proposal requests support to conduct a randomized clinical trial of a theory-based HIV~     treatment adherence intervention tailored for people with low-literacy skills.~   "
191196|NCT01061736|"~     Primary Objectives:~      Part A (dose ranging study):~      To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of~     signs and symptoms of rheumatoid arthritis at 12 weeks.~      Part B (pivotal study):~      To demonstrate that sarilumab added to MTX was effective in:~        -  reduction of signs and symptoms of rheumatoid arthritis at 24 weeks~        -  inhibition of progression of structural damage at 52 weeks~        -  improvement in physical function at 16 weeks~      Secondary Objectives:~      Part B:~      To demonstrate that sarilumab added to MTX was effective in induction of a major clinical~     response at 52 weeks~      To assess the safety of sarilumab added to MTX~      To document the pharmacokinetic profile of sarilumab added to MTX in participants with active~     rheumatoid arthritis who were inadequate responders to MTX therapy.~   "
191197|NCT01061723|"~     Primary objective:~      - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS)~     using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)~      Secondary objectives:~        -  to demonstrate that Sarilumab was effective on:~             -  assessment of higher level of response [ASAS 40% response criteria (ASAS40)]~             -  partial remission~             -  disease activity~             -  range of motion~             -  Magnetic Resonance Imaging (MRI) of the spine~        -  to assess the safety and tolerability of Sarilumab in participants with AS as well as~          the pharmacokinetic profile of Sarilumab in participants with AS~   "
191198|NCT01061710|"~     The purpose of this study is to collect the efficacy and safety information in subjects who~     have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for~     their appropriate use in daily practice and are participants for varenicline Drug Use~     Investigation protocol A3051109 ((NCT# NCT00772941).~   "
191199|NCT01061697|"~     This study is designed to investigate the effectiveness of pregabalin (Lyrica) on nerve pain~     caused by degenerative neck problems. Pregabalin is a new drug registered for use in nerve~     pain worldwide~   "
191200|NCT01061684|"~     The NAFLD Database 2 will recruit at least 650 new pediatric participants with liver biopsies~     and contemporaneous biosamples, and will also invite pediatric participants from the prior~     NAFLD Database and TONIC trial (50 with a recent biopsy and 150 without a contemporaneous~     biopsy) to enroll in the NAFLD Pediatric Database 2 study. Combining the new and continuing~     participants leads to a recruitment goal for the pediatric Database 2 of 850 pediatric~     participants during the enrollment period.~   "
191201|NCT01061671|"~     To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12~     months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung~     disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do~     not have other indications for statin treatment.~   "
191202|NCT01061658|"~     A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity~     of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine~     [BRV-TV]in Indian infants. The study would be carried out in 90 healthy infants. Three doses~     of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12~     and 14-16 weeks of age. The rotavirus vaccine would be administered at one of the two planned~     virus concentrations (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 ml). Each~     administration of the vaccine/placebo would be preceded by oral administration of 2.0 mL of~     antacid.~   "
191203|NCT01061645|"~     Immunotoxins (ITs), monoclonal antibodies conjugated to plant or bacterial toxins, have been~     extensively investigated for their possible use as anti-tumor agents although not in~     carcinoma patients with minimal residual disease. Various ITs have been tested in early~     clinical trials and recent studies demonstrate anti-tumor activity of IT treatment in~     patients with glioblastoma and different solid tumors. Systemic treatment with immunotoxins~     directed against carefully selected epithelial cell surface molecules may have a potential~     for eradicating also dormant metastatic tumor cells, as their action is independent of cell~     proliferation. The effector moieties of the IT used here, the Pseudomonas exotoxin A (PE),~     inhibits protein synthesis in eukaryotic cells by catalytic inactivation (ribosylation) of~     elongation factor 2 in the ribosome complex.~   "
191204|NCT01061632|"~     The aim of the study is to evaluate and compare the effects of high-intensity (deadlift)~     versus low-intensity motor control exercises on selfrated pain, function and symptoms on~     patients with peripherally mediated pain~   "
191205|NCT01061619|"~     The purpose of this study is to describe the prediagnostic symptoms and the events along the~     pathway to diagnosis of women with ovarian cancer, referred for first-line chemotherapy.~   "
191206|NCT01061606|"~     This phase II trial is studying how well temsirolimus works in treating patients with~     recurrent or persistent cancer of the uterus. Temsirolimus may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
191207|NCT01061593|"~     Dzherelo (Immunoxel) is an oral immunomodulating botanical agent available over-the-counter~     in Ukraine. After many years of laboratory and clinical testing the formulation was approved~     in 1997 by the Ministry of Health of Ukraine as a dietary herbal supplement, which enhances~     immunity against viral and infectious diseases. The goal of this study is to conduct~     confirmatory clinical trial in Ukraine and Mongolia for TB indications.~   "
191208|NCT01061580|"~     Injection of concentrated bone marrow cells into the myocardium during CABG procedure.~   "
191209|NCT01061567|"~     The general aim of this non-interventional study is to assess the safety and efficacy of~     pramipexole extended release in patients with Parkinson's disease in routine clinical~     practice.~   "
191210|NCT01061554|"~     The purpose of this study is to compare the short term absorption of EPA and DHA from~     triglycerides (TG) released from normal soft gel capsules and from the new patent pending~     vehicle providing a gastric stable emulsion.~   "
191211|NCT01061541|"~     In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a~     DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to~     be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5).~     The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine~     when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive~     Tritanrix™-HepB/Hiberix™.~      Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects~     50% were randomised to participate in the PRP challenge study (208108/092) (open), and all~     subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).~   "
191212|NCT01061528|"~     The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and~     acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation~     treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments,~     participants will receive one 60-minute individual session, seven 2-hour group sessions and~     two individual brief telephone contacts over an eight-week period. Both treatments include 8~     weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and~     will continue after the treatment sessions have ended. Participants will provide follow-up~     data with regard to their smoking status through a one-year follow-up period.~   "
191213|NCT01061515|"~     This study is to test escalating doses of intraperitoneal (IP) oxaliplatin in conjunction~     with systemic bevacizumab and capecitabine in patients with Peritoneal Carcinomatosis (PC)~     from either appendiceal or colorectal adenocarcinoma that have been adequately cytoreduced~     and have undergone a peritoneal scan demonstrating patency of at least one of the~     intraperitoneal ports that were placed at the time of debulking.~   "
191214|NCT01061502|"~     The purpose of this study is to determine whether the use of a bioelectric wound dressing is~     effective in the healing of skin graft donor site wounds.~   "
191215|NCT01061489|"~     Age-related cognitive decline is unavoidable. However, recent results of~     neuroplasticity-based research show that neuroplasticity-based training and physical activity~     might have the potential to decelerate or even reverse effects of aging and age-related~     cognitive impairments. Little is known whether these results also apply to pathological~     processes of aging such as mild cognitive impairment (MCI) and dementia.~      This multi-center study aims at investigating efficiency and feasibility of a~     neuroplasticity-based auditory discrimination training and a physical fitness training for~     patients suffering from mild cognitive impairment or mild Alzheimer's disease (Mini Mental~     State Examination, MMSE > 19). Evaluation will include neuropsychological testing,~     electroencephalography (EEG) and magnetic resonance imaging (MRI) measurements as well as~     blood and liquor analyses.~   "
191216|NCT01061476|"~     Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for~     the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is~     suboptimal in many patients, making alternative therapies desirable. Recently, a novel device~     (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the~     current study is to examine how well the Provent™ device treats OSA with particular attention~     to the how the it may treat sleep apnea and who may most likely benefit from the use of this~     treatment.~   "
191217|NCT01061463|"~     The purpose of this study is to test the existence of an increased risk of cataracts among~     interventional cardiologists as compared to cardiologists not exposed to X-rays.~   "
191218|NCT01061450|"~     Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals~     whose treatment remains unclear. Its presence is related to higher morbidity and mortality~     independent of blood pressure levels. The aim of this study is to investigate the additive~     effect of simvastatin on enalapril on DD in hypertensive patients with average cholesterol~     levels.~      For this aim, hypertensive patients with DD and LDL-cholesterol <160 mg/dL will undergo a~     run-in phase to achieve a systolic blood pressure (SBP) <135 mmHg and diastolic blood~     pressure (DBP) <85 mmHg with enalapril. Hydrochlorothiazide could be added when need to~     achieve SBP or DBP control. Four weeks after reaching the optimum anti-hypertensive regimen~     patients will be randomized to receive 80 mg simvastatin or placebo for a period of 20 weeks.~     Echocardiograms will be performed before and after treatment with measurement of left atrial~     volume, conventional and tissue Doppler velocities in early diastole and late diastole. The~     evaluation of these will allow to identify changes of DD severity after treatment.~   "
191219|NCT01061437|"~     The purpose of this study is to compare the effectiveness of three different antibiotic~     regimens against Helicobacter pylori (H. pylori).~   "
191220|NCT01061424|"~     This study compares an asthma self-management intervention, delivered to the family and~     tailored to their needs and cultural beliefs, to standard asthma education in high-risk~     Puerto Rican children in elementary school. The primary outcomes are asthma medication~     adherence and trigger reduction.~   "
191221|NCT01061411|"~     This phase I trial studies the side effects and best dose of dalteparin when given together~     with sunitinib malate in treating patients with kidney cancer that has spread to other parts~     of the body or cannot be removed by surgery. Anticoagulants, such as dalteparin, help prevent~     blood clots and have been shown to increase survival in patients with cancer. Anticoagulants~     may also prevent the formation of new blood vessels. Sunitinib malate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by inhibiting new~     blood vessels and blocking blood flow to the tumor. Giving dalteparin together with sunitinib~     malate may starve tumors and kill more tumor cells.~   "
191222|NCT01061398|"~     In patients with chest pain or shortness of breath who are referred for stress imaging tests~     (either stress echocardiography or stress nuclear testing), the investigators seek to compare~     impact of using cardiac CT scans of the heart arteries to the stress test that their doctors~     ordered.~   "
191223|NCT01061385|"~     The study evaluated the safety and efficacy of the ReShape Intragastric Balloon as an adjunct~     to diet and exercise in obese patients compared with diet and exercise alone. The study~     device is designed to occupy space within the stomach and induce satiety. After approval from~     the institutional review board, patients provided written consent and were randomized to the~     treatment group (with endoscopic placement of study device) or the control group (no~     placement of study device) on an unblinded basis. Both groups received similar diet and~     exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events,~     and quality of life data were evaluated throughout the 48 week study duration.~   "
191224|NCT01061372|"~     The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate~     to severe Restless Legs Syndrome in comparison to placebo.~   "
191225|NCT01061359|"~     Evaluation of efficacy of treatment with epirubicin (5 years follow-up). Evaluation of~     frequency of dose reduction. Evaluation of frequency of neoadjuvant treatment with E(120mg) /~     C(600mg). Evaluation of unexpected and serious adverse events.~      (E=Epirubicin; C =Cyclophosphamide)~   "
196885|NCT00986219|"~     The purpose of the study is to evaluate the concordance of the most frequently used words by~     the patients and the physicians to express asthma symptoms and the limitations of daily~     activities caused by asthma.~   "
191229|NCT01061307|"~     Iron, zinc and vitamin A deficiencies are particularly common among children and young women~     in the developing countries of South and Southeast Asia resulting in important adverse health~     effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel~     and sustainable approach to control these deficiencies.~      Recently conducted extrusion trials have demonstrated that extruded rice grains containing~     iron, zinc and vitamin A show acceptable stability during production and storage and good~     sensory properties. The grains were produced using a twin-screw extruder equipped with a~     special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded~     product is 10 mg, 9 mg and 1050 μg per g of rice, respectively.~      In this study the investigators plan to test the efficacy of the extruded triple fortified~     rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this~     area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc~     deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of~     the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention~     trial in 7-12 y-old children. Children will be selected from primary schools in Satun~     Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As~     secondary outcome the effect on iron and vitamin A status will be investigated. The children~     will be randomized into two groups: a control group will receive a daily non-fortified rice~     lunch meal at school, while the second group will receive a daily rice meal containing the~     triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and~     height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin,~     serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months,~     the baseline measurements will be repeated to judge the efficacy of the triple fortified~     rice.~   "
191230|NCT01061294|"~     The purpose of this study is to assess the efficacy, predictability and safety of the~     Advanced CustomVue™ iLASIK procedure (WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser~     System and IntraLase™ FS System). Patient data will be collected electronically and analyzed~     to determine improvements in postoperative visual acuity, visual quality and residual error.~   "
191231|NCT01061281|"~     The purpose of this study is to compare the visual outcomes with bilateral implantation of~     Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months~     after post cataract surgery.~   "
191232|NCT01061268|"~     To evaluate the safety and efficacy of BLINK™ tears compared with NO topical artificial tear~     use in improving subject's visual performance and reduce ocular symptoms of discomfort in~     subjects who have undergone cataract surgery implanted with a Tecnis™ diffractive multifocal~     intraocular lens (IOL).~   "
191233|NCT01061255|"~     Solving a problem in ambulatory setting may contain peripheral stress due to socio-evaluative~     stressors (patient's expectations about explanations) and task contingent stress due to time~     pressure, the necessity to take into account patient's mood, to deal with uncertainty of~     their own data collection and with complex clinical situations. In France, excepted for~     family medicine, undergraduate medical students and residents are currently not trained to~     perform consultations and are never exposed to ambulatory patients during training. The~     investigators postulate that this lack of practice may generate a significant state of stress~     during the first consultations and consequently modify or even impair clinical reasoning.~      The primary objective of this study is to compare subjective and physiological levels of~     acute stress in ambulatory versus hospitalization setting in medical students confronted to a~     real patient with a diagnostic problem.~      Measures: The French version of the Anxiety Spielberger test is administered just before and~     after each problem solving session.~      Cortisol salivary samples are taken before and after each problem solving session. Salivary~     cortisol levels have been shown to be correlated to stressful situations and some personality~     traits but with some difference according to gender.~      Cognitive appraisal (threat/challenge) is assessed before and after the tasks by the ratio of~     primary appraisal to secondary appraisal according to Tomaka et al.~   "
191234|NCT01061242|"~     The purpose of this study is to understand patients' neurocognitive performance shortly after~     discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep~     quality in the MICU on those neurocognitive outcomes. The investigators hypothesize that~     post-ICU neurocognitive function and patient overall ICU sleep experience will improve~     through a pre-existing MICU sleep improvement initiative.~   "
191235|NCT01061229|"~     The main aim of the study is to determine whether a homeopathic drug in the potency C12~     provokes more characteristic homeopathic proving symptoms after three weeks compared to a~     placebo in healthy volunteers.~      Secondary aims are to develop and to test a qualitative analysis methodology on which to base~     a definition for drug-specific (characteristic) symptoms and to compile a profile of~     characteristic homeopathic proving symptoms of the drug being trialled for therapeutic~     purposes.~      This study protocol adapts the traditional homeopathic drug proving methodology to a modern~     clinical trial design.~   "
191236|NCT01061216|"~     The primary objective of this study will be to assess the PK/PD responsiveness of basal ID~     administered insulin compared to SC, and to determine the safety and local tolerability of~     extended (two six-hour periods) microneedle insulin delivery (MID) infusion. The primary~     endpoint will be the PK response to changes in rapid-acting insulin basal infusion rate.~      Faster PK transitions coupled with faster PD responsiveness could provide clinical benefit,~     compared to current subcutaneous insulin infusion. In addition, for nocturnal basal pumping,~     more rapid insulin offset could decrease the occurrence rate and severity of hypoglycemic~     episodes.~   "
191237|NCT01061203|"~     Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with~     grass pollen allergy~   "
191238|NCT01061190|"~     The objective of this trial is to assess the safety and efficacy of neuro- and~     cardioprotective effects of propranolol in acute ischemic stroke. Furthermore, exploratory~     analyses of cardiologic-electrophysiologic and immunologic parameters will be performed.~   "
191239|NCT01061177|"~     This study will assess the efficacy and safety of nilotinib in adult patients with newly~     diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in~     chronic phase. The aim of the study is to confirm the rates of complete molecular remission~     (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population~     using the EUTOS standardized laboratories.~   "
191240|NCT01061164|"~     This study will examine the long-term effects of HIV infection, highly active antiretroviral~     therapy (HAART), and experimental treatments on children who participated in PACTG 219C or~     select IMPAACT studies.~   "
191265|NCT01060839|"~     -  In the formative stage of the project, we have investigated through qualitative and~          quantitative studies to identify a potential intervention to promote partner referral~          for sexually transmitted patients in Bangladesh.~        -  We conducted a quasi-randomised trial to evaluate if single session counseling is~          effective in improving partner referral for patients with sexually transmitted~          infection.~   "
191241|NCT01061151|"~     The purpose of this study was to examine, in an integrated and comprehensive fashion, three~     critical questions currently facing HIV-infected pregnant and postpartum women and their~     infants:~        1. What is the optimal intervention for the prevention of antepartum and intrapartum~          transmission of HIV?~        2. What is the optimal intervention for the prevention of postpartum transmission in~          breastfeeding (BF) infants?~        3. What is the optimal intervention for the preservation of maternal health after the risk~          period for prevention of mother-to-child-transmission ends (either at delivery or~          cessation of BF)?~      The overall PROMISE protocol had three separate interventional components to address each of~     these three questions and was conducted at locations in Africa and other parts of the world.~     Due to variations in the standard of care for HIV-infected pregnant and postpartum women and~     their infants at different sites, not all of these questions were relevant. Therefore, two~     separate versions of the PROMISE protocol were developed, each containing only the relevant~     components. The 1077BF protocol was used at sites where the standard method of infant feeding~     was breastfeeding, whereas the 1077FF protocol was used at sites where the standard method of~     infant feeding was formula feeding. The analyses were collapsed across the two protocol~     versions, and therefore the summaries contain the results of the 1077BF and/or the 1077FF~     protocols.~   "
191242|NCT01061138|"~     The primary objective of this study is to acquire digital mammography images produced by the~     Xpress Digital Mammography System in order to develop Computer Aided Detection software and~     systems.~   "
191243|NCT01061125|"~     This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to~     determine the clinical utility of the Implantable Loop Recorder. These type of patients~     either are monitored with weekly transtelephonic monitoring (TTM) or implantable loop~     recorder (ILR). The Medtronic Reveal XT loop recorder will be implanted at the time of the~     PVI or at the 3-4 month PVI follow-up visit and patient care will be managed based on~     randomization to a blinded or unblinded group. Outcome measures will be compared to aid in~     decision making regarding anticoagulation and overall post ablation clinical management.~   "
191244|NCT01061112|"~     This research study will help determine how a person's genetic makeup affects their responses~     to drugs, the ability of the body to break down drugs, and their potential to experience an~     interaction between drugs. We are investigating the drug interactions between an antifungal~     drug called fluconazole and the commonly used drugs tolbutamide, flurbiprofen, and~     ketoprofen. Tolbutamide is used for management of Type 2 diabetes. Both flurbiprofen and~     ketoprofen are non-steroidal anti-inflammatory drugs (NSAIDs) often used for arthritis or~     pain. We are interested in studying whether individuals with certain genetic profiles have~     different drug interactions than normal. This research is being done to see if certain~     genetic profiles require us to adjust medication doses differently than is needed for the~     general population. Genetic profiles of subjects are determined from their previous~     participation in the Pharmacogenetics Registry (Investigator Richard Brundage, University of~     Minnesota).~      The study hypothesis is: Fraction metabolized by CYP2C9 enzyme determines the extent of drug~     interactions in CYP2C9*1/*1 individuals but this factor (fraction metabolized) becomes less~     influential and drug interactions are attenuated in a gene-dose dependent manner in~     individuals with one or more defective alleles.~   "
191245|NCT01061099|"~     This is a study to evaluate the safety and effectiveness of repeated Mesenchymal Stromal~     Cells (MSC) infusions to patients with Type II or III osteogenesis imperfecta (OI).~      Participants will receive MSC infusions approximately every 4 months to complete a total of 6~     infusions over 20 months. Participants will be followed for 4 months post their last MSC~     infusion.~   "
191246|NCT01061086|"~     This is a multicenter, 2-phase observational study of acute coronary syndromes (ACS) in~     Greece, designed to provide real world data on the risk factors of patients presenting to a~     hospital emergency department with an index event, as well as to depict the current~     management practices and outcomes of these clinical conditions in Greece.~   "
191247|NCT01061073|"~     JJ ureteral stent represents an advance in the management of the upper urinary tract~     obstruction as it allows the patient to resume his activities although he is stented between~     the kidney and the bladder.~      However, in many cases, this JJ stent is not well tolerated and can even be unbearable.~      This trial evaluates the benefit of tamsulosin (an alpha-blocker) in improving the tolerance~     of JJ stents compared to low-doses of phloroglucinol.~   "
191248|NCT01061060|"~     This study attempts to examine the effect of oral prostaglandin I2 (Beraprost Na),~     administered for eight weeks, on the endothelial cell functional disorder among asymptomatic~     high risk diabetes mellitus patients.~   "
191249|NCT01061047|"~     Ertapenem is an antibiotic that is highly bound to plasma protein (> 95%). The effects of~     this high protein binding on tissue distribution of antibiotics have been few evaluated yet.~      In this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically~     ill patients (patients with infection due to an Ertapenem susceptible bacteria). Indeed,~     these 2 populations show changes in binding capacity of drugs to plasma proteins due to a~     decrease of protidaemia and of the affinity of drugs to transport proteins.~      It seems therefore important to clarify the consequences of a modification in protein binding~     on distribution of antibiotics. That's why we have decided to characterize tissue~     distribution of ertapenem in healthy volunteers and critically ill patients by assessing:~     free and total concentrations in plasma and free concentrations in muscle by microdialysis.~   "
191250|NCT01061034|"~     Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion~     while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid~     secretion.~      We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on~     platelets.~      healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.~      All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin~     and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.~      Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC),~     0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin~     plus Omeprazole on day 21.~      Platelet function tests will be determined by platelet-rich plasma aggregometry in response~     to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on~     day 0 as baseline and on day 7 and 21 of the study.~   "
191253|NCT01060995|"~     SUMMARY:~      The purpose of this study is to learn how to better educate patients about oral health~     procedures and treatments through an improved informed consent process. We will gather~     information from patients and health care providers, and design and test a computerized~     consent system called SmartConsent.~      HYPOTHESIS:~        1. Subjects who use SmartConsent will have increased knowledge (cognitive achievement)~          about oral health disease and treatment than patients who view the standard consent~        2. Subjects who use SmartConsent will have less decisional conflict in their decision~          regarding an oral health procedure than those who view the standard consent form~        3. Subjects who use SmartConsent will have greater visit satisfactions scores than those~          who view the standard consent form~   "
191254|NCT01060982|"~     This study is a multicentre, open, uncontrolled trial for the observation of histological~     changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).~      This study will be conducted in France in 10 patients with primary hyperparathyroidism~     scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center~     of the adenoma before the surgery.~   "
191255|NCT01060969|"~     To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in~     preventing acute mountain sickness in travelers to high altitude areas.~   "
191256|NCT01060956|"~     The purpose of this study is to determine whether identification of two different bacteria in~     urine culture of patients with indwelling catheter has a clinical impact - change in~     antibiotic, duration of antibiotic, days to clinical resolution and length of stay in~     hospital.~      The microbiology laboratory will randomized urine cultures with two bacteria from indwelling~     catheter to either reporting identity and susceptibility of the bacteria or reporting mixed~     growth.~   "
191257|NCT01060943|"~     -  Investigational Device : TheraFill® (Atelocollagen Dermal Filler)~        -  Title : A Randomized, Multicenter, Prospective and Paired Comparison of the Efficacy and~          Safety of TheraFill® versus KOKEN for 3months on Nasolabial Folds~        -  Sites and investigators :~             -  The Catholic University of Korea. Kangnam St. Mary's Hospital (#505, Banpo-dong,~               Seocho-gu, SEOUL)~             -  The Catholic Univ. of Korea Holy Family Hospital (#2, Sosa-dong, Wonmi-gu,~               Bucheon-si, Gyeonggi-do)~        -  Objective : To compare the non-inferiority of TheraFill® with KOKEN for evaluation of~          the efficacy and safety on Nasolabial Folds for 3months~        -  Clinical Study Method : Seventy-three subjects who agree to voluntarily participate in~          the clinical study are randomized to treatment with TheraFill (porcine atelocollagen~          filler) and KOKEN (bovine atelocollagen filler) in the contralateral fold(NFL). The~          subjects shall regularly visit the hospital 5 times or more and if subjects take~          touch-up treatments, the number of visit times will be increased. Treatments shall be~          repeated at 2 weeks intervals, as required, to achieve Optimal cosmetic result.~          Outcomes shall be evaluated by blinded investigators, investigators and subjects at 2,4~          and 12 weeks after baseline.~        -  Subjects : The target number of subjects is 62subjects, and 73 subjects are selected in~          the screening period in consideration of 15% of dropout rate.~   "
191258|NCT01060930|"~     Exposure to combustion-derived fine particulate air pollution is associated with~     cardiovascular mortality and morbidity. In previous studies, exposure to diesel exhaust (a~     major constituent of urban particulate air pollution) has been shown to impair two important~     functions of the vascular endothelium: vascular vasomotor function and endogenous~     fibrinolysis. Our subsequent studies suggest this impairment of vascular function is mediated~     by a reduction in nitric oxide bioavailability. In this study we aim to investigate the~     cardiovascular responses to systemic nitric oxide synthase inhibition following exposure to~     dilute diesel exhaust.~   "
191259|NCT01060917|"~     Continuous monitoring of the skin tissue glucose concentration on two different study days~     using glucose sensors that work on the principle of impedance spectroscopy, with systematic~     alteration of the blood glucose concentration using the glucose clamp technique in healthy~     subjects and subjects with type 1 diabetes. Simultaneous determination of electrolyte~     concentrations in the blood by taking frequent blood samples.~   "
191260|NCT01060904|"~     The purpose of this study is to assess the safety profile of brentuximab vedotin in~     combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin~     lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the~     maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of~     brentuximab vedotin in combination with frontline therapy.~   "
191261|NCT01060891|"~     Nosocomial infections have become a major health problem. They induced important use of~     antibiotics which is a preponderant factor for the development of bacterial resistance. The~     multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as~     Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently~     available, and the use of old molecules as Colistin may be the only alternative. However,~     there are few reliable data about Colistin and its PK characteristics. These data are~     essential to optimize its administration. The aim of the present study is to evaluate the~     pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous~     administration of Colistimethate alone or combined with inhaled Colistin in severely ill~     patients infected with multiresistant gram-negative bacteria~   "
191262|NCT01060878|"~     A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating~     early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified~     Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and~     well tolerated in this study and demonstrate therapeutic benefit in this patient population.~   "
191263|NCT01060865|"~     Almost 50% of hypertensive patients remain uncontrolled. Clinical decisions are mostly based~     on office blood pressure,despite the fallacies of this method of measurement. Other reasons~     for not achieving blood pressure targets are lack of 24-hr efficacy and tolerability of~     existing anti-hypertensive drug classes. Aliskiren (Rasilez®) is a new antihypertensive drug,~     given once a day.~      The purpose of the REALITY study-[tREAtment of essentiaL hypertension with rasIlez.~     evaluation of different methods of blood pressure measurements - efficacy and safeTY~     evaluation -] is to evaluate the efficacy, and tolerability of aliskiren in a real life~     setting. The efficacy of the drug will be evaluated using 24 hour ambulatory blood pressure~     monitoring (ABPM). Results will be compared with office, nurse or self blood pressure~     monitoring. This comparison will allow to decide which follow-up technique is better for~     those hypertensive patients.~   "
191266|NCT01060826|"~     Acute pancreatitis is the most frequent (5-10%) and severe complication after endoscopic~     retrograde cholangiopancreatography (ERCP), that could require of surgical intervention and~     lead to death. A double- blind study designed to evaluate if the treatment with somatostatin~     in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for~     4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted~     to ERCP will be randomized in two groups of treatment, one will receive somatostatin and~     another placebo. The main aim of this study will be the incidence of acute post-ERCP~     pancreatitis and secondary objectives will be identify sub-groups of patient with high risk~     to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the~     exploration. The study will include 510 patients submitted to an ERCP during a period of 3~     years.~   "
191267|NCT01060813|"~     This is a pilot study including 20 cirrhotic patients that will be randomized to receive~     during 3 months leucine vs leucine plus a programme of physical exercise specially designed~     for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could~     increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood~     ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients~     will be strictly assessed.~   "
191268|NCT01060800|"~     Duke University Medical Center is investigating the hereditary basis of Chiari type I~     malformations with or without syringomyelia (CM1/S). Our research is aimed at learning if~     CM1/S is indeed caused by factors inherited through the family and, if so, which genes are~     involved.~   "
191269|NCT01060787|"~     Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants~   "
191270|NCT01060774|"~     This study is testing a local anesthetic (numbing medicine) to suppress pain. Bupivacaine and~     lidocaine are FDA approved local anesthetics that may decrease pain following surgery.~     Patients will receive either 2% lidocaine, 0.5% bupivacaine, or placebo with epinephrine~     1:200,000 as a numbing medicine at the end of root canal surgery. Small pieces of gum will be~     taken before and after surgery and 2 days later to analyze chemicals that may be related to~     pain sensation.~   "
191271|NCT01060761|"~     The objective is to investigate a rehabilitation program (supportive conversations and a~     rehabilitation course for cancer patients and their relatives together).~      The study evaluate the effect of the program compared to no intervention (usual care)~   "
191272|NCT01060748|"~     This is a research study about an experimental (investigational) vaccine called ACE527.~     ACE527 is a vaccine that is being made to prevent disease from a germ called enterotoxigenic~     Escherichia coli (ETEC). This germ causes diarrhea, largely in children living in developing~     countries and in travelers to those countries. One purpose of this study is to see if the~     vaccine is safe and develops an immune response. Another purpose is to see if it prevents~     people from getting sick when exposed to the ETEC germ. This ETEC germ is also experimental~     (investigational).~   "
191273|NCT01060735|"~     Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily~     vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun~     exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.~      We hypothesize that larger doses of vitamin D are needed to be supplemented to all women~     during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin~     D and bone reserve as well on offspring vitamin D and bone status at birth and possible~     further on.~      The aim of the present study is to compare vitamin D and bone status of infants born to~     mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the~     third trimester of pregnancy.~   "
191274|NCT01060722|"~     This study aims to examine the safety, tolerability and pharmacokinetics of a long-lasting~     Human Growth Hormone (MOD-4023) in healthy volunteers after a single subcutaneous injection~     at escalating doses.~   "
191275|NCT01060709|"~     Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation~     prior to current sedation monitoring practices in order to prevent hypoxemia in sedated~     patients undergoing colonoscopies?~   "
191276|NCT01060696|"~     The infertility patients who are performed saline infusion sonohysterography (SIS) for~     studying the pathology inside the uterine cavity has pain. From pilot study the pain score is~     6.80. It will have more benefits if we can manage this procedure with less or no pain. Many~     studies have tried to decrease pain such as types of catheter, intrauterine lidocaine~     infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the~     procedure.The drugs are safe and easy to administration and chief.~   "
191277|NCT01060683|"~     The purpose of this study is to evaluate the accuracy of continuous SpHb measurement (~     Rainbow DCI, Masimo, Irvine Ca, USA) compared to the current method of monitoring (blood~     sampling), both during phases of hemoconcentration and hemodilution.~   "
191278|NCT01060670|"~     The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal~     Regeneration Template for the treatment of diabetic foot ulcers located distal to the~     malleolus in subjects with diabetes mellitus, neuropathy, and without significantly~     compromised arterial circulation.~   "
191279|NCT01060657|"~     To evaluate the clinical values of using dose reduction techniques in 64-row multi-slice CT~     coronary artery imaging.~   "
191280|NCT01060644|"~     The present study describes and evaluates the surgical protocol for sinus mucosal lining~     elevation of the maxillary sinus for Dental Implant Insertion without Bone grafting~     Underneath the Sinus Membrane.~   "
191281|NCT01060631|"~     The purpose of this study is to assess whether BIS values at return of consciousness are~     different in patients with or without brain tumors.~   "
191282|NCT01060618|"~     The summary of the Study is to compare two methods in order to predict how the 1-HIV will use~     a co-receptor: the use of an accredited test (TROFILE ESTA®) and the viral response to a CCR5~     antagonist in the short term.~   "
191283|NCT01060605|"~     Numerous changes to the original Edmonton protocol have been proposed in the attempt of~     improving the still unsatisfactory long-term function of ITA. Rapamycin may blunt the early~     inflammatory response to islet transplantation in the liver, thus favoring islet engraftment.~      Aim of the investigators study was to evaluate the effect of a pre-transplant treatment with~     rapamycin in patients with type 1 diabetes receiving islet transplant alone and~     immunosuppression according to the Edmonton protocol.~   "
191284|NCT01060592|"~     Subjects having a gastric band fitted will have the first band adjustment done at surgery.~     The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter,~     band adjustments will be made using an adjustment chart, created at surgery, which shows~     stoma size versus band fill, to make adjustments in the normal follow-up visits. It is~     hypothesized that an early adjustment at surgery will promote earlier weight loss, and result~     in fewer band adjustments being required in the first year after surgery.~   "
191285|NCT01060579|"~     A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in~     treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The~     ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be~     different from that of an active control.~   "
191286|NCT01060566|"~     The objectives of this study are to evaluate the effects of VX-770 on Midazolam and~     Rosiglitazone, and the effect of Fluconazole on VX-770.~   "
191287|NCT01060553|"~     The purpose of this study is to examine if acupuncture improves Post-Traumatic Stress~     Disorder symptoms among veterans who participated in Operations Enduring Freedom and Iraqi~     Freedom. This study will also examine the degree of veteran acceptance for acupuncture.~   "
191288|NCT01060540|"~     In this 6-month randomized, controlled trial, we examined whether providing participants with~     genetic test results and counseling regarding their risk for type 2 diabetes would motivate~     them to improve their health behaviors and lose weight to reduce their diabetes risk. We~     hypothesized that participants who received conventional diabetes counseling plus genetic~     test results and counseling would have at least 6 lb greater weight loss at 3 months than~     participants who received conventional diabetes counseling without genetic test results.~   "
191289|NCT01060527|"~     Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder haracterised by~     abdominal pain or discomfort associated with altered bowel habits,while the mechanism is~     still not understood.Recent advances have conceptualized the faecal supernatants of~     diarrhoea-predominant IBS have a substantially higher serine protease activity, while in~     china,almost no studies have reported about protease activity in IBS.~   "
191290|NCT01060514|"~     The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that~     can be given together without causing severe side effects. Also, this study will evaluate~     what effects (good and bad) that the treatment has on patients and their cancer.~   "
191291|NCT01060501|"~     The primary objective was to improve adjuvant 5-FU chemoradiotherapy in resectable rectal~     cancer. The investigators hypothesis was that modulation of 5-FU by addition of either FA or~     INF-alpha may increase overall survival.~   "
191292|NCT01060488|"~     The aim of the study is to determine the specificity and sensitivity of the combined growth~     hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly~     probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.~   "
191293|NCT01060475|"~     LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.~   "
191294|NCT01060462|"~     The purpose of this observational study is to examine the rate at which elevated body~     temperature (fever) is relieved by an itraconazole injection administrated to patients~     experiencing neutropenic fever . A neutropenic fever is an elevated body temperature that~     occurs at a time when the patient's white blood cell count is low. White blood cells aid the~     body's normal defenses against infection, so a fever during this period might make it~     difficult for the patient to fight infections.~   "
191295|NCT01060449|"~     Cardiac resynchronization therapy (CRT) is a device implanted to improve the function of some~     people's hearts. CRT involves the placement of 3 wires in the heart through a vein near the~     front of your left or right shoulder into three pumping chambers of the heart, the most~     important being the left lower chamber, left ventricle (LV).~   "
191296|NCT01060436|"~     The purpose of this pilot study is to find out whether successful treatment of obstructive~     sleep apnea makes people look less sleepy, for example by reducing swelling or dark circles~     under the eyes. In addition, this study will help determine whether facial photographs may be~     used to help identify patients who should be tested for sleep apnea and daytime sleepiness.~   "
191297|NCT01060423|"~     The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in~     combination with intravenous cetuximab versus intravenous irinotecan in combination with~     intravenous cetuximab in the treatment of patients with unresectable liver metastases from~     colorectal cancer.~      Secondary objectives are safety and tolerability of hepatic chemoembolization and the~     question if the addition of aprepitant to standard antiemetic prophylaxis in patients treated~     by hepatic chemoembolization is safe and will reduce the rate of acute and delayed nausea and~     emesis.~   "
191298|NCT01060410|"~     The purpose of this study is to investigate the relationship between the side effects of~     cyclophosphamide in the treatment of systemic lupus erythematosus (SLE) in Han Chinese and~     the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of~     cyclophosphamide.~   "
191299|NCT01060397|"~     Heavy alcohol consumption leads to various health problems and is now recognised to be an~     important public health problem. This is evidenced by the huge media attention recently~     focused on the use and misuse of alcohol, particularly by younger patients. At least 1 in 20~     of the population in the UK are physically and psychologically dependent on alcohol. This not~     only has consequences for the physical and psychological well-being of these patients, but~     has adverse consequences for their family, work life and society in general. Current~     treatments are mostly delivered in specialist units, which are few in number meaning that few~     patients get access to these services. This leads to a vicious cycle which results in~     multiple hospital admissions, ineffective treatments and continual drinking. It is therefore~     vital the investigators develop alternative effective treatments for these patients which can~     interrupt this vicious cycle.~      In patients who drink heavily, but are not yet alcohol-dependent, a treatment called brief~     intervention can help reduce overall alcohol consumption, and improve health and wellbeing.~     However, whether a similar intervention can help alcohol-dependent patients has not yet been~     established.~      In this study, the investigators aim to identify, treat and support alcohol-dependent~     individuals. Using an enhanced form of BI (termed extended brief intervention, EBI) as the~     basis of clinical care, the investigators will undertake a randomised trial comparing EBI~     with usual clinical care. The investigators will use various clinical and behavioural~     measures to assess the effectiveness of this treatment. The investigators will also be asking~     patients how they felt, and what they think of their treatment and the professionals~     delivering that treatment. If EBI is shown to be effective and is not too costly, it could~     provide a national framework for treatment of alcohol-dependent patients. This could~     potentially improve both the opportunities to access treatment and the choice of treatments~     available to patients.~      The investigators hypothesis is that Extended Brief Interventions (EBI) delivered to~     alcohol-dependent patients in a hospital setting by an Alcohol Specialist Nurse (ASN) will be~     effective in reducing overall alcohol consumption and improving the standard measures of~     alcohol dependence.~   "
191335|NCT01059929|"~     This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged~     sedation (> 24 hours) in critically ill patients who require mechanical ventilation.~   "
191300|NCT01060384|"~     The purpose of this trial is to investigate the efficacy (how well the drug works) of~     ofatumumab and lenalidomide in patients with lymphoma and to investigate if any possible~     unwanted side effects may occur. The purpose of the Phase I portion of this trial will be to~     determine the maximum dose of these medications that can be given with minimal side effects.~   "
191301|NCT01060371|"~     Spinocerebellar ataxias (SCA) are genetic neurological diseases that cause imbalance, poor~     coordination, and speech difficulties. There are different kinds of SCA and this study will~     focus on types 1, 2,3, and 6 (SCA 1, SCA 2, SCA 3 , also known as Machado-Joseph disease and~     SCA 6). The diseases are rare, slowly progressive, cause increasingly severe neurological~     difficulties and are variable across and within genotypes. The purpose of this research study~     is to bring together a group of experts in the field of SCA for the purpose of learning more~     about the disease.~      The research questions are:~        1. How does your disease progress over time?~        2. What are the best ways to measure the progression?~        3. Do some genes, other than the gene that is abnormal in your disease, have any effect on~          the way the disease behaves?~      This is a nationwide study and we expect that 800 patients will participate all over the USA.~     The participants will be in the study for an indeterminate period of time. Study visits will~     be done every 6 or 12 months depending on the participating site.~   "
191302|NCT01060358|"~     The purpose of this study is to verify the existence of neuromuscular neutral zones(NNZs) in~     humans, and develop non-invasive techniques to measure intervertebral kinematics of the~     lumbar spine. The results will be used to accurately quantify NNZs in humans, and provide a~     foundation for clinical trials on low back pain patients using this methodology.~   "
191303|NCT01060345|"~     The purpose of this study is to find molecular signs (biomarkers) to better understand the~     role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed~     ductal carcinoma in situ (DCIS).~   "
191304|NCT01060332|"~     Diabetic Mellitus is the fifth cause of death by the report of Department of Health in 2008,~     and it often cause the severity of other chronic diseases. Neuropathy, retinopathy and~     renopathy are the most prevalent complications of DM, and they often influence the quality of~     life.~      300 patients with Diabetic neuropathy will be recruited in Taichung Veterans General Hospital~     endocrine and metabolism clinics. Body Constitution Questionnaire(BCQ), Diabetes Impact~     Measurement Scales(DIMS), Short Form -36(SF-36) will be asked to filled up, neurological~     examination (NE), AC sugar, HbA1c, lipid profiles, liver and kidney functions will be~     measured in order to evaluate the correlation between body constitution and quality of life~     on patients with diabetic complication.~   "
191305|NCT01060319|"~     We hypothesize that all human malignancies harbour a subpopulation of tumor initiating~     cells/cancer stem cells (CSCs) that drives tumor development and potentially recurrence or~     metastasis of the disease. The primary aim of this study is to develop strategies for~     prospective isolation/enrichment of CSCs from human tumors of different tissue origins. In~     addition, we will characterize the signaling pathways and/or tumor specific antigens that are~     specific for CSCs, in order to specifically target these CSCs as the endpoint of this study.~   "
191306|NCT01060306|"~     PONTINA aims at assessing by optical coherence tomography the neointimal coverage of the~     biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug~     elution and polymer biodegradation (6 months), at one month after this time-point (7 months)~     and, as a comparator, of its bare metal stent counterpart (Gazelle stent) at 1 month after~     implantation.~   "
191307|NCT01060293|"~     The aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose~     furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical~     status, renal function, electrolyte balance, length of stay, and 60-day post-discharge~     outcomes in patients hospitalized with acute decompensated heart failure.~   "
191308|NCT01060280|"~     A cluster, randomized, controlled clinical trial, where the hypothesis is that Group GDS and~     Individual GDS are effective in the treatment of nonspecific low back pain. The clusters will~     be the participating physiotherapy departments in primary care who treat patients with low~     back pain. In each physiotherapy department there will be 3 groups: education group, Group~     GDS and Individual GDS. Patients will be followed for 12 months. Variables will be:~     demographic,intensity of pain, disability, quality of life, patient satisfaction, medication~     intake for current episode, non-pharmacologic treatment for current episode, co-morbidity,~     diagnostic tests, sick leave, and habitual physical activity. The questionnaires to be used~     are: Roland Morris Disability Questionnaire, PI-NRS, VAS, SF-12 and EQ-5d.~   "
191309|NCT01060267|"~     Objectives:~      Blood in stomach & oesophagus in patients with variceal bleeding often obscures the~     endoscopic view & makes endoscopic intervention difficult to perform. Erythromycin, a motilin~     agonist induces gastric emptying. The aim of this study was to assess the effect of~     Erythromycin on endoscopic visibility and its outcome.~   "
191310|NCT01060254|"~     The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of~     JNJ-42160443 compared to placebo in patients with moderate to severe, chronic bladder pain~     from interstitial cystitis and/or painful bladder syndrome.~   "
191311|NCT01060241|"~     This project will test the effectiveness of an Internet based glucose monitoring system on~     the A1C levels of patients with type 2 diabetes. All of the patients are given a meter and~     test strips to test their blood glucose levels, however, half of them will be required to~     also upload their meter onto the Internet which can then be viewed by their endocrinologist.~     The doctor can then send a message back to the patient and comment on the readings. The~     effect of the ongoing communication will be measured by the changes in the glucose levels~     (HbA1C) over 3 and 6 months.~   "
191312|NCT01060228|"~     The purpose of this study is to evaluate the effect of valproic acid (VPA) on the~     pharmacokinetics (blood levels) of a single oral dose of an extended-release formulation of~     paliperidone in healthy male volunteers.~   "
191313|NCT01060215|"~     The purpose of this study is to assess the effects of joint effusion on proprioceptive status~     in patients with knee osteoarthritis (OA).~   "
191336|NCT01059903|"~     The major aim of this study is to investigate and compare the drug amount delivered to the~     body after sequential application of two Rotigotine patches of two different formulations~   "
191337|NCT01059890|"~     The aim of the study is to explore the distribution of antibiotics in the brain after an~     acute brain injury because brain infections treatment is still an health care problem.~   "
191314|NCT01060202|"~     This study will observe the degree of the quality of life in non-transplant candidate~     patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ~     C30 (European Organization for Research and Treatment of Cancer Quality of Life~     Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions). Both tools are validated research~     instruments used to measure the quality of life in cancer patients and consequently will~     provide fundamental data regarding the quality of life in patients with multiple myeloma by~     analyzing factors that affect the quality of life.~   "
191315|NCT01060189|"~     Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic~     transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but~     expensive, and has been proved to link to higher risks of serious side effects including~     renal problems, myocardial events, and strokes in patients undergoing CABG. After the~     secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac~     surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin,~     urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide~     inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic~     effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The~     objective of the study is to evaluate the hemostatic and anti-inflammatory effect of~     ulinastatin and tranexamic acid in cardiac surgery.~   "
191316|NCT01060176|"~     Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has~     seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in~     cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The~     current study includes patients receiving valvular replacement and coronary artery bypass~     surgery. Different dosage of tranexamic acid is delivered and blood loss, transfusions and~     clinical outcomes are recorded. The study hypothesis is that tranexamic acid could reduce~     blood loss and allogeneic transfusion in cardiopulmonary bypass cardiac surgery. Furthermore,~     tranexamic acid could decrease inflammatory reaction in cardiac surgery.~   "
191317|NCT01060163|"~     The use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), has~     become a standard management strategy for patients with acute coronary syndrome. On this~     background, an increasing percentage of patients presenting for surgical coronary~     revascularization is the subject to irreversible platelet inhibition.~      Investigations on the effect of antiplatelet treatment on postoperative bleeding after~     cardiac surgery have shown that patients treated with antiplatelet agents until surgery have~     increased postoperative bleeding, and also an increased need for transfusions of blood~     products. As a result of the antiplatelet effect of clopidogrel, the frequency of serious~     bleeding complications has increased significantly, as seen in patients requiring coronary~     artery bypass grafting(CABG), especially when they received clopidogrel until surgery.~      Tranexamic acid(TA) is a widely used antifibrinolytic agent, and is a promising substitute~     for aprotinin when the latter has seceded in 2007.The release of plasmin during~     cardiopulmonary bypass(CPB) activates fibrinolysis and may contribute to platelet~     dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate~     platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding.~     Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.~      Concerning the cessation of aprotinin and the increasing proportion of patients with~     persistence on clopidogrel until their surgery, evolutional work is expected, especially in~     the eastern population.~      The purpose of this study is to assess the effect of tranexamic acid in patients with~     clopidogrel and asprin ingestion until surgery. The investigators working hypothesis was that~     tranexamic acid would lower postoperative blood loss and transfusion requirements in these~     patients and would attenuate bleeding complication of antiplatelet therapy.~   "
191318|NCT01060150|"~     The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic~     Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in~     Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).~   "
191319|NCT01060137|"~     The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing~     patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and~     a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix~     is designed to deliver medication at a nearly constant amount per unit time into the body~     through the skin for 3 days (72 hours).~   "
191320|NCT01060124|"~     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic~     System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so~     the drug will enter the body through the skin) treatment in cancer participants of Korea with~     inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and~     participant's satisfaction.~   "
191321|NCT01060111|"~     The purpose of this study is to investigate the adequacy (reasonably good) of topiramate~     therapy (medicine or medical care given to a participant for a disease or condition) in~     prevention of migraine (type of severe headache that occurs periodically and is often~     associated with nausea, vomiting, and constipation or diarrhea) by comparing standard~     titration (slow increase in drug dosage, guided by patient's responses) therapy to slow~     titration therapy and slow titration therapy boosted by the concurrent use of propranolol in~     participants with migraine with or without aura (having to do with the ear) for more than or~     equal to 2 attacks per month.~   "
191322|NCT01060098|"~     Inflammatory arthritis particularly rheumatoid arthritis, psoriatic arthritis and ankylosing~     spondylitis are potentially disabling conditions which cause joint pain, swelling and~     deformity and treatments are aimed at preventing these complications. Although treatment has~     improved with the advent of antiTNFalpha therapies, up to 30% of patients fail to respond to~     this treatment and in others, treatment is associated with significant side effects. The~     precise mechanisms of this remain unclear. In addition, there are no sensitive methods~     available to monitor or predict disease response to treatment aside from testing inflammatory~     markers in the blood. Understanding the mechanism of action and what governs response to~     antiTNF therapy will allow development of more specific therapies for inflammatory arthritis.~     Work in animal models of rheumatoid arthritis has characterised a novel cell type, Th17~     cells, important in the inflammatory cascade which are affected in a particular way by~     antiTNF therapies and may underpin their mechanism of action and side effects. We aim to~     translate these findings into patients with rheumatoid arthritis and other conditions treated~     with anti-TNF therapy, such as psoriatic arthritis and ankylosing spondylitis. Patients from~     rheumatology clinics within NHS trusts will be recruited. We will correlate disease activity~     assessed by clinical parameters, ultrasonography and questionnaires with biomarkers in the~     blood and target tissues, such as synovium and skin.~   "
191338|NCT01059877|"~     This study will employ a double-blind, placebo-controlled approach to assess the effect of~     1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with~     early and mid-stage dementia.~   "
197750|NCT00974662|"~     The aim of this study is to determine the dose of WST11 and light energy necessary to obtain~     desobstruction of the bronchial lumen using Vascular Targeted Photodynamic therapy in~     obstructive Non-Small Cell Lung Cancer.~   "
191323|NCT01060085|"~     The primary objective of this study is to compare the diagnostic accuracy of Digital Breast~     Tomosynthesis (DBT) versus that of Contrast Enhanced Magnetic Resonance Imaging (CEMRI) in~     determining the size of breast cancer preoperatively.~      Secondary objectives include:~        1. Comparing the operating characteristics of each combined imaging protocol with respect~          to the reference standard, i.e. histopathologic assessment, of additional non-index~          lesions.~        2. Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI~          vs. adjunctive DBT.~        3. Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs.~          CEMRI).~   "
191324|NCT01060072|"~     This study is being conducted to compare the safety and efficacy of loteprednol etabonate to~     vehicle for the treatment of postoperative inflammation and pain following cataract surgery.~   "
191325|NCT01060059|"~     Although the efficacy and safety profile of exenatide has been well established, few data~     exist on the real world results of exenatide treatment in specific populations and clinical~     settings. This study is intended to fill this gap through observing and collecting~     prospective data from a population of Italian patients initiating treatment with either~     exenatide or basal insulin formulations after failure to achieve glycemic control with oral~     antihyperglycemic agents (OHA).~      Observational studies represent noninterventional research; therefore, this study does not~     involve randomization of patients to particular comparator arms or therapies. The term~     noninterventional means that the healthcare providers decisions regarding the proper~     treatment and care of the patient are made in the course of normal clinical practice.~     Patients enrolled in this study are enrolling for the collection of their data on~     observations made during normal clinical practice.~   "
191326|NCT01060046|"~     The purpose of this study is to investigate what happens to biologic mesh in the body over~     time on a molecular level. To date, it is not known what agents, enzymes, or proteins are~     interacting at the implantation site that contributes to mesh remodeling and/or degradation.~     Investigators on this project will identify patients with previously placed mesh who are~     needing reoperation on the same site and take a biopsy of the mesh during the normal course~     of surgery. Basic data surrounding the surgical procedure will be collected. The mesh samples~     will be analyzed for enzymes and proteins and examined histologically for processes that~     signify remodeling and/or degradation. Control patients will undergo biopsy of abdominal~     fascia at laparoscopic trocar sites in a manner that will not affect the outcome(s) of their~     procedure or other risk to the incision site.~   "
191327|NCT01060033|"~     To detect differences in MR spectroscopy, diffusion weighted MR, diffusion tensor imaging~     (DTI) or dynamic contrast enhancement (DCE) MR imaging between primary cervical tumors and~     normal cervical tissue.~   "
191328|NCT01060020|"~     Pulmonary hypertension is common in patients with aortic stenosis and is associated with~     worse operative and long-term outcomes. Sildenafil has been shown to reduce pulmonary artery~     pressure and improve exercise performance in patients with left-sided heart failure, but this~     has not been tested in patients with aortic stenosis. We hypothesize that Sildenafil will~     produce a clinically significant decrease in pulmonary artery pressure in patients with~     severe aortic stenosis. The dose of Sildenafil that produces a significant decrease in~     pulmonary artery pressure will be safe and well tolerated in patients with and without a~     depressed ejection fraction.~   "
191329|NCT01060007|"~     To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at~     or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while~     maintaining response rates comparable to what would be expected with radiotherapy and~     concurrent chemotherapy.~   "
191330|NCT01059994|"~     This is a pilot study funded by the National Institutes of Health. In this project, we will~     investigate the potential effect of skeletal muscle nitric oxide (NO) production on muscle~     strength and physical function in older individuals. We propose to test a new method that may~     enable simultaneous determination of both vascular and skeletal muscle NO production for the~     first time in humans. Further, we will determine whether augmentation of NO-mediated~     responses, by administration of sildenafil citrate (Viagra), reduces fatigue and fatigability~     in older individuals.~   "
191331|NCT01059981|"~     The 'Analysis of Emergency Department Volumes during Natural Disasters' retrospective study~     focuses on three specified populations including dialysis patients, trauma patients, and~     patients poisoned by carbon monoxide. These three populations have one commonality -~     hurricanes, ie. natural disasters, which is the exposure. Causal associations and significant~     correlations will be explored in all three subgroups.~   "
191332|NCT01059968|"~     This study examines the role of energy availability on menstrual function and bone mass in~     female adolescent endurance athletes. Specific evaluations include dietary intake, exercise~     energy expenditure, training schedules, menstrual function and bone density.~   "
191333|NCT01059955|"~     This is an initial clinical trial evaluating whether different doses of iontophoresis for~     delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections,~     non-necrotizing scleritis. A secondary goal is to get preliminary information about whether~     the treatment is likely to be an effective treatment for scleritis. If the results are~     favorable, further trials evaluating the treatment may be pursued.~      Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.~   "
191334|NCT01059942|"~     The aim of this project is to develop and validate a simple, flexible, reliable, real-time~     observation tool to evaluate hand-off practices. The Hand-off CEX is a paper-based instrument~     that can be used to evaluate either the sender or the receiver of hand-off communication.~     This tool is based on a previously-validated, widely-used, real-time educational evaluation~     tool (the Mini-CEX); published expert opinion; and our prior research . The investigators'~     tool incorporates unique role-based anchors for both senders and receivers that refer to~     verbal communication, professionalism and environment, hand-off domains informed by~     preliminary work and expert opinion. The Hand-off CEX(Clinical Evaluation Exercise) will be~     used by academic hospitalists and house-staff physicians to assess feasibility. We, the~     investigators, will also assess the construct validity and inter-rater reliability of the~     tool through the use of standardized, videotaped hand-off scenarios depicting various levels~     of performance of a hand-off scenario.~      We hypothesize that the Hand-off CEX will arm educators with an innovative, necessary, valid~     and feasible method for training health professionals to conduct safe and effective~     hand-offs. Finally, the Hand-off CEX will be a useful tool to assist hospitals in improving~     patient safety.~   "
191339|NCT01059864|"~     All patients will be in instructed to eat a therapeutic lifestyle diet and will receive~     CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the~     cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first~     measure the effects of CP-690,550 on cholesterol levels and then the effects of adding~     atorvastatin on those levels.~   "
191340|NCT01059851|"~     This study will investigate whether the plasma concentration-time profile and~     pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function~     are similar to those observed in healthy participants; and will evaluate the safety and~     tolerability of suvorexant both in participants with impaired renal function and in healthy~     participants.~   "
191341|NCT01059838|"~     The purpose of this study is to determine whether speech recognition in noise can be improved~     by the addition of a special listening program to the sound processor. Thus we propose to~     assess speech perception in noise for pediatric cochlear implant patients using both their~     everyday listening program as well an ASC program.~   "
191342|NCT01059825|"~     MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational~     drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus.~     Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment~     with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.~   "
191343|NCT01059812|"~     This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin~     degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with~     type 2 diabetes not optimally controlled on once or twice daily insulin with or without~     metformin.~   "
191344|NCT01059799|"~     This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin~     degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in~     subjects with type 2 diabetes never treated with insulin.~   "
191345|NCT01059786|"~     Background:~        -  Researchers are attempting to develop new treatments for hairy cell leukemia (HCL) that~          has not responded well to or has recurred after standard HCL therapies. One nonstandard~          treatment for HCL is rituximab, an antibody that binds to the cancer cells and helps the~          immune system destroy them. By combining rituximab with other anti-cancer drugs,~          researchers hope to determine whether the combined drugs are successful in treating HCL.~        -  Pentostatin and bendamustine are two anti-cancer drugs that have been used to treat~          different kinds of blood and immune system cancers. Bendamustine is approved to treat~          other kinds of leukemia and lymphoma, but it has not been used to treat HCL. Pentostatin~          has been used for more than 20 years to treat HCL, but it has not been combined with~          rituximab in official clinical trials.~      Objectives:~        -  To determine whether rituximab with either pentostatin or bendamustine is a more~          effective treatment for HCL than rituximab alone.~        -  To determine whether pentostatin or bendamustine is a more effective treatment for HCL~          when combined with rituximab.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with hairy cell leukemia that~     has not responded well to or has relapsed after standard HCL therapies.~      Design:~        -  The study will last for four treatment cycles of 28 days each.~        -  Prior to the study, participants will be screened with a full medical history and~          physical exam, bone marrow biopsy (if one has not been performed in the last 6 months),~          computed tomography (CT) or ultrasound scan, tumor measurements, and other tests as~          required by the researchers. Participants will provide blood and urine samples at this~          time as well.~        -  Rituximab with bendamustine: Participants will receive rituximab on Days 1 and 15 of~          each cycle and bendamustine on Days 1 and 2 of each cycle, for a total of four cycles.~        -  Rituximab with pentostatin: Participants will receive rituximab on Days 1 and 15 of each~          cycle and pentostatin on rituximab on Days 1 and 15 of each cycle, for a total of four~          cycles.~        -  Participants will have regular tests during the treatment cycles, including bone marrow~          biopsies and CT or ultrasound scans. Participants will also provide regular blood and~          urine samples to assess the results of treatment.~   "
191346|NCT01059773|"~     This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who~     receive ustekinumab following an inadequate response to methotrexate therapy. The study will~     provide information for doctors on how to manage the transfer from methotrexate to the~     biologic agent ustekinumab. The study is designed to compare two methods of transferring~     patients from methotrexate to ustekinumab. The two methods being compared are discontinuation~     of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab~     with overlap and gradual dose reduction of methotrexate over 4 weeks.~   "
191347|NCT01059760|"~     The purpose of this study is to evaluate the effect of fasting on physical changes associated~     with cardiovascular disease.~   "
191348|NCT01059747|"~     Addiction has been regarded as one of the most serious health and social problems in Taiwan,~     and heroin is currently considered to be the major substance of abuse. The most widely used~     treatment to date is methadone replacement therapy. It is reported that to achieve a better~     clinical response and to avoid possible side effects, the blood level of methadone should~     remain in a certain level. However, the blood level of methadone is mediated by various~     factors besides dosage. Genetic variability in genes that encodes enzymes affecting methadone~     metabolism, target receptors of methadone, and drug-drug interaction by other medication~     patients take will all affect blood level. Therefore, therapeutic drug monitoring (TDM) and~     pharmacogenomic study is crucial for evaluating and predicting the clinical response, cause~     of side effects or toxicity, as well as studies on drug-drug interactions.~      This is a cross-sectional study in order to evaluate the relationship between methadone~     plasma level and clinical response in patients under methadone maintenance therapy and to~     identify optimal therapeutic thresholds. HPLC will be used to analyze methadone and its~     metabolites. Our hypothesis is that methadone plasma levels in patients who are responsive to~     methadone maintenance therapy are higher than level in non-responsive patients, and higher~     plasma level leads to less severe withdrawal symptoms. We will also test if an optimal~     minimal dosage exists among these patients. In the meanwhile, we will aim to test if~     methadone level and clinical response is correlated with different genetic polymorphism.~     Candidate genes that involve in pharmacokinetic and pharmacodynamic process of methadone~     (e.g. CYP3A4, CYP3A5, CYP2B6, ABCB1, opioid mu receptor and kappa receptor) will be genotyped~     for these analyses.~      The results of this study will provide clinical information of methadone treatment and~     pharmacogenomic data in Taiwanese for clinicians to achieve a better treatment outcome.~   "
191349|NCT01059734|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at biomarker expression in bone marrow samples from~     patients with acute myeloid leukemia.~   "
191350|NCT01059721|"~     Soft tissue realignment of the tibial insertion of the patella tendon is a simple operative~     technique for treating dislocation of the patella in childhood and adolescence. It is~     performed in children with either recurrent dislocation or complicated primary dislocation in~     cases with malalignment or maltracking of the patella and a lateralised tibial tuberosity. It~     can be performed in patients with open epiphyses. We investigate long-term outcome after this~     procedure.~   "
191351|NCT01059708|"~     Carbon monoxide poisoning is common. Many adults with CO poisoning have long-term, even~     permanent brain injury following poisoning. However, very little is known about the long-term~     outcome of children with carbon monoxide (CO) poisoning. In this study we plan to perform~     cognitive (thinking) and vestibular (balance) testing in children (ages 6 to 16)at 6 weeks~     and 6 months following CO poisoning.~      At the 6-week visit, if the child and parents agree, we will ask each child to provide a DNA~     sample by one of three methods: mouthwash, spit collection, or swabbing the inside of the~     child's cheek. Each child's DNA will be analyzed for genes that are known to affect outcome~     following brain injury.~   "
197871|NCT00973050|"~     The objective of this study is to compare the rate and extent of absorption of bicalutamide~     50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under~     fasting conditions.~   "
191352|NCT01059695|"~     Analysis of all women treated for cervical cancer between 2000 and 2008 in Limburg, a~     province in the south of the Netherlands. Patient characteristics, diagnosis, treatment~     modalities, complications and survival will be analyzed by record review. Quality of life of~     the living study population will be assessed using the EORTC QLQ-C30 and QOQ-CX24~     questionnaire. Patients will be identified via registration data from the Integraal~     Kankercentrum Limburg.~   "
191353|NCT01059682|"~     This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect~     of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker~     profile and long-term safety profile of dalcetrapib in patients with coronary artery disease.~     Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound~     (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial~     Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have~     coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg~     orally once a day or placebo. The anticipated time on study treatment will be 24 months. The~     target sample size is 800-1000 patients.~   "
191354|NCT01059669|"~     To develop a new standardized multimodal diagnostic approach to CP considering:~      WP 1: Fat in faeces and functional testing; the combination of tests has to be easy to~     practice, should take as little time as possible and discomfort for the patient has to be~     minimized WP 2: Advanced ultrasonography and imaging modalities. The focus is on validating~     standard parenchymal, contrast enhanced and functional ultrasound compared to a modern~     imaging standard. (CT, EUS, MRI)~      To evaluate the reliability and feasibility of these novel methods in healthy volunteers; AND~      To compare findings in known severe CP patients and different stages of pancreatic~     insufficiency in patients with CP.~   "
191355|NCT01059656|"~     In relation to the activation of PDGF-mediated signalization due to the fusion gene~     COL1A1-PDGFb in DFSP, imatinib (800mg/day) has shown activity in advanced DFSP and has became~     the reference treatment option for these patients. Yet the activity observed does not allow~     for a downstaging compatible with successful resection in a number of patients and does not~     prevent subsequent tumour progression in case of residual tumour.Pazopanib in relation to 1)~     its multi tyrosine kinase inhibiting activity (VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-α, PDGFR-β~     and c-kit with IC50 values of 10, 30, 47, 71, 84, and 74 nM, respectively) involving in~     particular PDGFR, and VEGFR which has been shown to be activated in DFSP, 2) its antitumour~     activity in sarcomas patients, and 3) its acceptable safety profile, is a logical candidate~     for therapeutic trials in DFSP both in patients not expected to derive a sufficient benefit~     from imatinib and in patients failing imatinib mesylate. Moreover, using quantitative RT-PCR~     and immunohistochemistry we have recently demonstrated high levels of VEGF and VEGFR2~     expression in dermatofibrosarcoma.~   "
191356|NCT01059643|"~     The purpose of the study is to estimate the rate of response for patients with ovarian,~     non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who~     are administered LY2523355.~   "
191357|NCT01059630|"~     This open-label, multicenter, randomized Phase III study will investigate the efficacy,~     safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined~     with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy)~     compared with bendamustine alone treatment in participants with rituximab-refractory indolent~     Non-Hodgkin's lymphoma (iNHL).~   "
191358|NCT01059617|"~     This study is designed to characterize the safety and immunogenicity of a' pandemic influenza~     (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received~     influenza vaccination.~   "
191359|NCT01059604|"~     Anti-migraine drugs, including triptans, are not indicated for use in pregnancy. However, the~     peak prevalence of migraine is in women of childbearing age. This, coupled with the sporadic~     nature of migraine attacks and high rates of unplanned pregnancies, makes unintentional~     exposure to anti-migraine medications during pregnancy likely. Prior to an anti-migraine~     medication being marketed there are few data available on drug safety in pregnancy: data from~     animal models may not translate directly to humans and pregnant women are routinely excluded~     from clinical trials. The Sumatriptan Pregnancy Registry was established by GlaxoSmithKline~     (GSK) in 1996 to monitor the safety of sumatriptan during pregnancy. It was combined with the~     Naratriptan Pregnancy Registry in 2001 and data collection on the sumatriptan-naproxen~     combination (Treximet) began in 2008.~   "
191360|NCT01059591|"~     This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the~     drug has on human health (safety and tolerability) and the amount of drug which gets into the~     bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to~     investigate the penetration of the drug in the human brain by using PET (Positron Emission~     Tomography) imaging technology~   "
191361|NCT01059578|"~     This is the first study in humans with GSK206136 to evaluate what effects: good or bad, the~     drug has on human health (safety and tolerability) and the amount of drug which gets into the~     bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to~     investigate the penetration of the drug in the human brain by using PET (Positron Emission~     Tomography) imaging technology~   "
191362|NCT01059565|"~     The purpose of this research study was to determine if an experimental drug called Aztreonam~     for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections~     in patients with cystic fibrosis (CF).~      Spirometry was used to assess pulmonary function, and the revised Cystic Fibrosis~     Questionnaire (CFQ-R) was used to assess quality of life. The CFQ-R is a validated,~     patient-reported outcome tool used to measure health-related quality of life for children and~     adults with CF.~      The study consisted of a 24-week randomized phase, and a 24-week open-label phase. Primary~     and secondary efficacy analyses were conducted for the 24-week randomized phase only. Safety~     data were collected for both the randomized and open-label phases.~   "
191363|NCT01059552|"~     The purpose of this study is to determine the maximum tolerated dose of the combination of~     vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage~     IIIA/IIIB non-small cell lung cancer.~   "
191364|NCT01059539|"~     The objective of this study is to evaluate the long-term safety, tolerability, and~     pharmacokinetics of cariprazine in patients with bipolar I disorder.~   "
191365|NCT01059526|"~     The objective of this study is to evaluate the formation of antibodies, the occurence of~     allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients~     treated with KALBITOR (ecallantide).~   "
191366|NCT01059513|"~     This is an observational study in which a questionnaire is used to obtain quality of life~     data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy~     (SBRT) for the treatment of their prostate cancer. The SBRT itself is considered standard of~     care for these patients and as such, is not an official component of the study.~   "
191367|NCT01059500|"~     Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk~     Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation,~     intravenous contrast and anticoagulation. This project addresses question of whether~     quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer~     algorithms (the project webtool), can improve the diagnostic evaluation of adult patients~     with charted evidence of chest pain and dyspnea. After a validation phase, the main study~     will randomize patients to either the Standard care group or the Intervention group, which~     will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and~     PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion~     with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.~   "
191368|NCT01059487|"~     At a time when there is so much focus in the United States on reducing the cost of health~     care delivery while maximizing the effectiveness of health care performance, Traditional~     Chinese Medicine (acupuncture, herbal treatment, and accessory techniques) offers decision~     makers a tantalizing option. Traditional Chinese Medicine differs from its biomedical~     counterpart in that it is highly portable, inexpensive to administer, relies on a~     conversational diagnostic inquiry system to arrive at differential diagnosis for its~     patients, and has very few reported side effects associated with treatment. The World Health~     Organization cites acupuncture has a proven and effective treatment for 28 diseases/disorders~     including stroke, pain management issues and rheumatoid arthritis; the WHO lists another over~     65 diseases for which the therapeutic effect of acupuncture has been shown but for which~     further proof is needed including alcohol dependence, cancer pain and diabetes mellitus. With~     the completion of this pragmatic clinical trial and introduction of the Constant Care method~     of health care delivery to underserved communities on Chicago's south side, the investigators~     can both utilize an effective plan of health care delivery, advance the research needed to~     effectively utilize Traditional Chinese Medicine as a low cost therapeutic option in this~     country, and successfully treat disenfranchised populations that have been traditionally~     overlooked and that deserve a better health and wellness care future.~   "
191369|NCT01059474|"~     DMPS is a metal chelator which is approved for use in Europe. While not an FDA-approved drug~     in the US, it is easily obtained and administered by alternative health practitioners to~     their patients. A formulation called 'TD DMPS' (transdermal DMPS) is in use, despite the fact~     there is no published literature to support that the agent is absorbed transdermally. The~     investigators hypothesis is that DMPS is not absorbed through the skin. The investigators~     plan to apply TD DMPS to healthy volunteers and then test serum for presence of DMPS. In~     addition the investigators will measure urinary mercury concentrations pre and post DMPS~     application.~   "
191370|NCT01059461|"~     The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy~     will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic~     encephalopathy after hospital discharge.~   "
191371|NCT01059448|"~     This is an extension study for subjects who participated in Protocol 20090061 (NCT00950989).~     All subjects in this study will receive a 210mg injection of AMG827 for treatment for their~     Rheumatoid Arthritis for up to 5 years.~   "
191372|NCT01059435|"~     The primary objective of this study is to assess the safety and tolerability of AMG 785~     following a single dose subcutaneous (SC) or intravenous (IV) administration in healthy men~     and postmenopausal women.~   "
191373|NCT01059422|"~     The study will investigate whether combination antiretroviral therapy of raltegravir and~     3TC/ABC is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving~     rifabutin-containing, first-line antituberculous treatment.~      Hypothesis:Combination antiretroviral therapy of raltegravir and 3TC/ABC and is effective and~     safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-based first-line~     antituberculous treatment.~   "
191374|NCT01059409|"~     Total or subtotal meniscectomies in young patients are currently responsible of pain and~     limitation of activities. There isn't any other treatment than meniscal replacement. But~     there is no randomized clinical trial on meniscal allograft to validate the efficiency of~     this treatment.~   "
191375|NCT01059396|"~     This is a multicenter, randomized, double-blind, placebo-controlled study on the~     effectiveness of treatment with beta-blockers to prevent decompensation of cirrhosis with~     portal hypertension.~   "
191376|NCT01059383|"~     The study is designed to assess the effect and safety of oral administration of VECAM 40/300~     administered at bedtime compared to Esomeprazole 20 mg administered 30-60 minutes before~     dinner, for control of nighttime and daytime HB and other 24 hour GERD symptoms.~      The rational for the study is based on the contention that VECAM exhibits potent inhibition~     of acid secretion and because of its mechanism of action, it can be administered at bedtime~     without food. Such timing of drug dosing will allow effective inhibition of nighttime acid~     secretion. Because of its mechanism of action, VECAM exhibits improved 24-hour inhibition of~     acid secretion and hence, its bedtime administration will not compromise its effect during~     the daytime. This improved control of acid secretion will predictably result in better~     control of nighttime as well as daytime heartburn (HB) symptoms.~   "
191377|NCT01059370|"~     Autonomic dysreflexia in high spinal cord-injured can be initiated by a full bladder or~     bowel, or when trying to empty either. This randomised study aims at evaluating whether~     irrigation procedure or digital stimulation or evacuation of the rectum is less provocative~     of autonomic dysreflexia. Participants have their bowels emptied on different days, in the~     morning fasting. Bladder filling with sterile saline water is evaluated on a third day as a~     control.~   "
191378|NCT01059357|"~     The purpose of this study is to conduct a pilot single-arm to assess transoral robotic~     surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci~     Robotic Surgical System.~   "
191379|NCT01059344|"~     The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg~     tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to~     placebo in subjects with active ulcerative colitis (UC).~   "
191380|NCT01059331|"~     The aim of the study is to investigate if perioperative administration of pregabalin vil~     reduce postoperative pain and the postoperative need for intravenous opioids compared with~     todays standard treatment which consist of paracetamol, corticoids and ketobemidone.~      In addition potential sideeffects as sedation and effect on cognitive function will be~     recorded.~   "
191381|NCT01059318|"~     This is an exploratory study. The purpose of the study is to determine whether escalating~     doses of RAD001 (everolimus) is safe and effective in patients with Lymphangioleiomyomatosis~   "
191382|NCT01059305|"~     The goal of this clinical research study is to learn if Tarceva ® (erlotinib) when taken~     before and after radiation and/or surgery can help to control aggressive cutaneous squamous~     cell carcinoma. The safety of the drug will also be studied.~   "
191383|NCT01059292|"~     TIPE2, a negative regulator of innate and adaptive immunity that maintains immune~     homeostasis. The investigators want to know whether TIPE2 is a risk factor for graft loss and~     gives rise to the immune dysfunction in renal transplant patients.~   "
191384|NCT01059279|"~     There now causation between Heat Intolerance and FMF that were showed in studies till now. We~     suggest that the prevalence of Heat Intolerance in the group of the FMF patients will be~     significantly higher than in the group of healthy individuals, that participated in the study~     of Heller Institute of Medical Research. The aim of the study is verification of causation~     between these pathologies. The information obtained by the study may allow us to determine~     the sequence of events associated with FMF attack development, and perhaps take us one step~     further in the understanding of the pathogenesis of the disease.~      15 FMF patients with double mutations MEFV, mail sex, from the age from 18 to 30 without~     attacks during not less than 2 month will participate in the study. To identify an~     individuals susceptibility to exercise heat test, a Heat Tolerance Test (HTT) will perform,~     according to HTT Protocol of Heller Institute of Medical Research.~   "
191385|NCT01059266|"~     This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses~     will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks)~     compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).~      The primary parameter will be the proportion of patients who experience systemic reactions >~     grade I within 24 hours after injection or who need more than 2 additional injections during~     the up-dosing phase until the maintenance dose has been reached.~      It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as~     using the conventional regimen.~   "
191386|NCT01059253|"~     Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive~     training exercise and balance device. The use of the AdvanStep will bring about a measurable~     improvement in the individuals balance in standardized measures.~   "
191387|NCT01059240|"~     Background:~        -  Spinal muscular atrophy (SMA) is a degenerative and incurable neuromuscular disorder~          that is caused by mutations in the survival motor neuron gene, SMN1, found on chromosome~          5. It is the leading inherited cause of infant mortality. SMA carriers (those who have~          the genetic mutation but do not have the disease) are often unaware of their status~          until they are tested.~        -  Researchers have been studying the prevalence of SMA carriers in the general population,~          but most of the information collected has come from populations within the United~          States, Europe, and Asia. Very few studies have been performed in Africa. Furthermore,~          this information does not provide much information regarding carrier frequency based on~          ethnic background and ancestry. To address this problem, researchers are interested in~          studying the prevalence of the SMA genetic mutation in the sub-Saharan nation of Mali.~      Objectives:~      - To collect blood samples for use in studying genetic data related to spinal muscular~     atrophy.~      Eligibility:~        -  Healthy volunteers who are at least 18 years of age.~        -  Volunteers will be of Malian ancestry and nationality.~      Study Location:~      -<TAB>Bamako, Mali, West Africa~      Design:~        -  The study will first collect blood samples from a small group of volunteers to run~          initial SMA carrier testing and resolve any technical difficulties before continuing~          with the study.~        -  Participants will complete questionnaires about their personal and family medical~          history, including questions about illnesses, stillborns, and miscarriages, and then~          will provide blood samples for genetic research and testing.~   "
191388|NCT01059227|"~     Background:~      - Research has shown that the hormone corticotropin-releasing hormone (CRH) is involved in~     stress and anxiety, and that drugs that block the effect of CRH in the body can reduce~     anxiety. GSK561679 is an experimental drug that attempts to reduce anxiety by blocking the~     effect of CRH. Researchers are interested in comparing GSK561679 with other treatments for~     anxiety.~      Objectives:~      - To determine the effectiveness of GSK561679 compared with placebo and alprazolam (Xanax),~     as a possible treatment for fear and anxiety.~      Eligibility:~      - Healthy female volunteers between 21 and 50 years of age.~      Design:~        -  This study will involve one screening visit, four testing visits, and one follow-up~          visit over a period of 8-9 weeks. The testing sessions will be between 6-11 days apart.~        -  Participants must follow these dietary restrictions to participate in the study.~        -  No nicotine, alcohol, or caffeine (including chocolate and soft drinks) for 24 hours~          before the start of the study.~        -  No nicotine in the past 6 months, and no nicotine until the final blood sample is~          collected at the follow-up visit.~        -  No alcohol or caffeine for 24 hours before a testing visit or for 72 hours after each~          visit.~        -  No grapefruit or grapefruit products from 14 days before the first dose of study~          medication until collection of the final blood sample.~        -  Participants will receive a dose of GSK561679, alprazolam, or placebo 3 hours before the~          testing, and will take an additional pill 1 hour before the testing.~        -  During the tests, participants will receive brief electric shocks and hear sudden loud~          noises. The noises and shocks will be given over a period of approximately 40 minutes~          per session.~        -  Skin conduction, heart rate, and blinking will be monitored throughout the tests, and~          participants will be asked about anxiety levels and will be tested on mood, memory, and~          concentration. Blood and saliva samples will also be taken during these sessions.~        -  Participants will stay in the clinical center for 1 to 2 hours after the study testing~          to ensure that the sedation has worn off. Participants will not be allowed to drive home~          or take public transportation alone after study visits, so alternative transportation~          must be arranged.~   "
191421|NCT01058785|"~     In this Phase II clinical trial the investigators will use four human non-small cell lung~     cancer cell lines that have been previously established in tissue culture laboratory. The~     investigators will gene modify these tumor cells in the laboratory to block their TGF-beta~     secretion. The investigators will inject the genetically engineered cells as vaccines in~     patients with stages II to IV non-small cell lung cancer. Our rationale for using other~     people's tumor cells is that lung tumor cell lines belonging to different people have been~     shown to share common characteristics that are recognized by non-self immune systems.~   "
191422|NCT01058772|"~     The purpose of this study is to determine whether, in Gestational Diabetes Mellitus (GDM)~     pregnancies, induction of labour at 38-39 weeks of pregnancy is superior to expectant~     management in terms of maternal and neonatal outcomes.~   "
191389|NCT01059214|"~     Background:~        -  INFUSE AMI is an ongoing clinical trial examining how patients with heart attacks are~          treated. The study's aim is to help determine the best way to treat patients with~          specific kinds of heart attacks caused by blood clots.~        -  To evaluate the effect of the heart attack on the heart tissue and function,~          participants in the INFUSE-AMI study will have magnetic resonance imaging (MRI) scans of~          the heart at specific times after their heart attack.~      Objectives:~      - To perform cardiac MRI scans on patients who are participating in the INFUSE-AMI study.~      Eligibility:~      - Individuals at least 18 years of age who are enrolled in the INFUSE-AMI study.~      Design:~        -  Participants will have an MRI scan of the heart about 5 days and between 23 and 44 days~          after their heart attack. The MRI scan at day 5 is optional.~        -  Participants will provide a blood sample prior to the MRI scan.~        -  During the scan, participants will be given a contrast drug to show the blood flow to~          and within the heart. An electrocardiogram will be used to monitor the heart during the~          procedure.~        -  No other treatment will be provided in this protocol.~   "
191390|NCT01059201|"~     Background:~        -  Research into the genetic causes of autism spectrum disorder (ASD) involves studies of~          the DNA of children with autism. New DNA sequencing technology allows researchers to~          study specific genes in search of genetic changes that may cause or contribute to ASD.~          Individuals who donated DNA to the Autism Genetic Resource Exchange may benefit from~          further study of their DNA samples with more advanced DNA sequencing technology.~        -  The role of cholesterol in individuals with ASD is currently under investigation.~          Research has suggested that abnormal cholesterol levels in children with autism may be~          related to genetic mutations or changes in how cholesterol is regulated in the body.~      Objectives:~      - To study existing blood samples of children with autism spectrum disorders to evaluate the~     relationship between genetic traits and cholesterol function.~      Eligibility:~      - Children with ASD who donated blood samples to the Autism Genetic Resource Exchange.~      Design:~      - Parents/guardians of minor children with ASD will provide consent for further research to~     be performed on existing DNA samples in the Autism Genetic Research Exchange databank.~     Information from this research may be provided to the consenting parents/guardians on a case~     by case basis, as directed by the researchers.~   "
191391|NCT01059188|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of~     radiation directly to the tumor may kill more tumor cells and cause less damage to normal~     tissue. Giving these treatments before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying the side effects of giving cetuximab together with~     cisplatin and docetaxel before radiation therapy and cetuximab followed by surgery and to see~     how well it works in treating patients with stage IIIB non-small cell lung cancer that can be~     removed by surgery.~   "
191392|NCT01059175|"~     Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF)~     refractory to optimal medical management, in presence of a depressed left ventricular (LV)~     ejection fraction and a wide QRS complex. It is mainly limited by a high proportion of~     non-responders. Attempts have been made, in small studies, to increase the number of~     stimulation sites in order to optimize the resynchronization therapy. V3 is a planned~     multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred~     by the addition of a second endocardial or epicardial LV lead in non-responders after at~     least 6 months of standard biventricular stimulation.~      The V3 trial will examine the clinical benefit conferred by the addition of a second LV lead~     in non-responders compared to standard CRT.~   "
191393|NCT01059162|"~     The aim of the study is to evaluate the safety and effectiveness of the IOPtiMate (OT-135P)~     in Laser Assisted Non-Penetrating Glaucoma surgery in Open-Angle and Pseudoexfoliative~     Glaucoma patients.~   "
191394|NCT01059149|"~     The aim of the study is to determine if 2-week repetitive transcranial magnetic stimulation~     at the subacute phase of stroke (between day 7 and day 14) improves significantly arm~     motility at 3 months with remaining effect at one year, without significant adverse effect.~   "
191395|NCT01059136|"~     Study hypothesis : An early blockade of aldosterone receptors initiated at the first medical~     contact after acute myocardial infarction may reduce major cardiovascular events within 6~     months after the occurrence of the myocardial infarction.~      Primary efficacy criterion : The 6 month rate of the composite of death, resuscitated cardiac~     arrest, potentially lethal ventricular arrhythmia, indication for implantation of an~     implantable cardioversion device, occurrence or aggravation of heart failure.~      Primary objective: To demonstrate the superiority of aldosterone blockade initiated as soon~     as possible within 72 hours after the onset of acute myocardial infarction on top of standard~     therapy, compared to standard therapy alone, with or without reperfusion therapy.~      Study design : Prospective, multi-centre randomised, open labeled with 2 parallel study arms.~   "
191396|NCT01059123|"~     The propose of this study is to determine whether a 6-day duration of oral amoxicillin~     treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral~     amoxicillin regimen. This trial will be open but evaluation will be perform by a blind~     evaluator.~   "
191397|NCT01059110|"~     The principal objective of the study is to compare 5 usual strategies in the management of~     plantar warts which did not cure after 5 weeks of a salicylate ointment given just prior the~     trial. The trial will include immunocompetent patients coming from the community and should~     help the office-based dermatologists and hospital in the decision-making therapeutic process.~   "
191398|NCT01059097|"~     The independent impact of surgeon volume on outcome of patients undergoing~     pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of~     pancreatic fistula rate was found in the high-volume surgeon group in comparison with~     low-volume surgeon group. However, no difference between groups was found in mortality, major~     complications, and hospital stay.~   "
191399|NCT01059084|"~     The purpose of this study is to look at the effect of daily herpes medication, valacyclovir,~     on HIV levels in the blood in persons who are HIV positive and do not have oral or genital~     herpes.~   "
191400|NCT01059071|"~     The purpose of this research study is to evaluate a new investigational drug to treat~     neuroblastoma. This study drug is called DFMO. The objectives of this study will be to~     monitor for safety and to find a maximum tolerated dose in this population. A secondary~     objective will be to look at efficacy of DFMO.~      The safety of the proposed dosing regimen in this trial will be tested by an on-going~     risk/benefit assessment during the study. A patient benefiting from treatment, not~     progressing on therapy, and in the absence of any safety issues associated with DFMO and/or~     etoposide may continue on treatment with the expectation that there will be an overall~     clinical benefit.~      The procedures involved in this study include Medical history, Physical exam, Vital signs~     (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the~     tumor(s), MIBG scans, and Bone marrow aspirations. All of these tests and procedures are~     considered standard of care for this population. Drug administration is also part of this~     protocol, including an investigational new drug called DFMO, and later combined with an~     already approved drug, etoposide.~      The proposed dosing regimen is an oral dose of DFMO two times a day for each day while on~     study. There will be 5 cycles. Each cycle will be 21 days in length. The first cycle will be~     DFMO alone. In the second cycle etoposide will be added in and will be given orally once a~     day for the first 14 days of each cycle (cycles 2-5).~   "
191401|NCT01059058|"~     The purpose of this study is to learn more about the management of white spot lesions that~     occur after orthodontic treatment. White spot lesions generally improve slightly with time.~     To date, there is no proven method to help white spot lesions improve faster. Two treatments,~     called MI Paste Plus and fluoride varnish, have shown some potential benefits in a laboratory~     setting but have not undergone testing in a clinical setting. Approximately 240 subjects are~     to be enrolled in this study. The study will take place in approximately 30 dental and~     orthodontic offices across Idaho, Montana, Oregon, Utah, and Washington as part of Northwest~     PRECEDENT, a five-state research network that was created to study the practical issues~     facing dentists/orthodontists and their patients, and to provide information that will~     improve the quality of oral health care as a whole. Researchers at the University of~     Washington and Oregon Health & Science University share management and oversight of the~     network and research projects.~   "
191402|NCT01059045|"~     Prospective controlled study evaluating cryocontact therapy of infantile hemangiomas of~     preterm infants~      Principal investigator: Rangmar Goelz, MD Coworkers: M Möhrle, M Moll, HM Häfner, W~     Schippert, C Meisner, M Röcken, CF Poets~      Background Despite their frequent occurrence, there is no established therapeutic procedure~     for localized infantile hemangioma in preterm infants. A PubMed search with the key words~     hemangioma, controlled study, infant or childhood revealed five studies (1-5), none of them~     included preterm infants, even though low birth weight and prematurity have been described as~     the most significant risk factors~      Aim:~      To evaluate cryocontact therapy of infantile hemangioma (IH) of 1 - 10 mm diameter in preterm~     infants <=34 weeks of gestational age (GA) using a liquid nitrogen cooled metal at the~     Department of Neonatology at the Tuebingen University Hospital.~      Method:~      In a prospective controlled study, preterm infants <= 34 weeks GA with at least 2 IH should~     be randomized to have one treated with cryocontact therapy using a liquid nitrogen cooled~     metal (-196°C), while the other one is left untreated. Primary endpoint is an intact skin at~     the site of the hemangioma at 1 year corrected age . The study starts at August 1st, 2004.~     Cryocontact is done by 3 trained dermatologist (MM, HMH, WS), outcome documentation,~     including photodocumentation, by 2 neonatologist (RG, MoMo).~      Statistical Analysis: A sample size of 25 intrapersonal pairs of treated and untreated IH is~     needed to show a significant difference with alpha=0.05 and beta=0.9 between treated IH and~     controls, assuming that 5% of the treated IH and 40% of the controls have an unsuccessful~     primary outcome. Documentation will be made on standardized forms and the data will be~     transferred to Excel. Biometric calculations will be handled with SAS 9.1.3. for Windows~     using Fisher´s Exact Test for difference in proportions.~      Ethics:~      The study is approved by the Ethics Committee of Tuebingen University Hospital; all parents~     must give written informed consent.~   "
191403|NCT01059032|"~     Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection~     has become a major issue in the radiological community. Optimizing CT scanning is a key task~     when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post~     processing filters can improve and restore grainy and noisy low dose CT images by enhancing~     structure and reducing image noise. In our study of 10 patients, the investigators perform a~     preliminary evaluation of a novel post processing filter, which does picture element~     correlations in all three spatial dimensions. By comparing normal dose pictures with~     unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three~     dimentional (3D) filters,the investigators will be able to assess the possible clinical value~     of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud~     University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical~     Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.~   "
191404|NCT01059019|"~     The purpose of this study is to demonstrate that omega-3 supplement can be use as an adjunct~     therapy for PRK patients. The investigators believe that omega-3 supplement will reduce the~     size of persistent epithelial defects (PEDS) and eventually hasten the corneal~     reepithelialization after PRK surgery. If the outcome of this study proves to be effective,~     then PRK would be a more attractive option to those seeking refractive treatment.~   "
191405|NCT01059006|"~     The aim of this study is to analyze the results of PresbyLASIK performed using the~     wavefront-optimized LASIK for the treatment of presbyopia on low hyperopic and low myopic~     patients with astigmatism. Visual performance will be assessed using clinical outcome~     measures of the following: refraction, near, intermediate and distance visual acuity,~     stereoacuity and contrast sensitivity. Questionnaires will also be used to evaluate how the~     patient's vision is before and after surgery.~   "
191406|NCT01058993|"~     This is an initial study to determine if CXCR4 inhibitor AMD 3100 or plerixafor may be a~     potential treatment for neutropenia due to CXCR4 mutations, the myelokathexis or WHIM (warts,~     hypogammaglobulinemia, immunodeficiency and myelokathexis) syndrome. This is the initial~     study of this concept and will involve up to 6 patients to receive increasing doses of~     plerixafor administered subcutaneously or on an alternate day basis. It is unknown if these~     patients will be highly sensitive to a blockade of CXCR4 activity and release more white~     blood cells than normal volunteers or cancer patients given the same dose of this drug.~     Therefore doses will begin at a level 12 fold less than currently used to mobilize stem cells~     and will be increased stepwise to achieve an acceptable circulating level of neutrophils.~   "
191423|NCT01058759|"~     Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy~     or in combination with Enoxaparin in patients aged older than 18 years with locally advanced~     or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study~     hypothesis: Increase of progressive free survival from 5 to 7.5 months.~   "
191407|NCT01058980|"~     Atrial fibrillation (AF) is the most common heart rhythm disorder, impairs quality of life~     and increases stroke risk and mortality. Despite advances in medical treatment, AF remains~     uncontrolled in many patients. In many patients, AF is initiated by abnormal electrical~     impulses from the pulmonary veins. A catheter ablation procedure called pulmonary vein~     isolation (PVI) has therefore been developed, using heat to isolate the PV foci from the~     heart. PVI is very effective, but must be repeated in up to 50% of cases because the foci~     isolation is not permanent after initial PVI. The intravenous administration of a drug called~     adenosine during the PVI procedure can unmask residual conduction that would otherwise remain~     unnoticed, so-called dormant conduction. In our experience, additional ablation guided by~     adenosine reduces AF recurrence and the need for a repeat PVI procedure. However, the~     adenosine-guided approach has not yet been proven as standard therapy. The present study, to~     be conducted at 15 clinical centres in Canada, Europe and Australia is therefore intended to~     evaluate the efficacy of adenosine-guided ablation to prevent AF recurrence. Five hundred~     twenty-six patients will be included in the study, which should be completed within 2 years.~     In all patients, the presence of dormant conduction will be tested with adenosine during PVI.~     If dormant conduction is observed, additional ablation will be performed in half of these~     patients selected randomly. If there is no dormant conduction, randomly selected patients~     will be followed in a registry. If the adenosine-guided approach is demonstrated to improve~     the success rate of PVI procedures, it should become the standard approach for a permanent~     cure of AF, and therefore benefit patients by reducing arrhythmia recurrence,~     hospitalizations and the need for repeat interventions.~   "
191408|NCT01058967|"~     The purpose of this study is to investigate the use of ultrasound by aeromedical prehospital~     providers.~   "
191409|NCT01058941|"~     The purpose of this study was to see if taking lipoic acid plus omega-3 fatty acids~     (omega-3s) can slow the Alzheimer's disease (AD) process. To see if the treatment can slow~     the AD process, the investigators looked at changes in memory and changes in a person's daily~     activities over 18 months.~   "
191410|NCT01058928|"~     Fluid leak around the cuff is minimized when the endotracheal tube size is small relative to~     the size of the trachea. In the current study, the investigators assess the influence of~     different HVLP endotracheal tube size on fluid leakage around the cuff in a benchtop model~     and in anesthetized patients.~   "
191411|NCT01058915|"~     In patients with ST-segment elevation acute myocardial infarction (STEMI) increased~     LDL-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization~     (changes in plaque composition) and plaque regression over 12 months beyond the benefit of~     moderate LDL-cholesterol reduction (rosuvastatin 5 mg) (assessed by IVUS and VH).~   "
191412|NCT01058902|"~     Lung cancer is the most common cancer in the western world. Only 10 to 15 % of patients~     diagnosed with lung cancer are suitable for potentially curative surgical treatment. Despite~     surgery, recurrence of lung cancer still occurs. Aspirin potentially may help increase~     survival by altering the biochemistry of any potential remaining lung cancer cells. Most lung~     cancer occurs in smokers. Smokers are at increased risk of heart attacks and strokes. Aspirin~     has beneficial effects on the heart and brain, potentially reducing the incidence of heart~     attacks and strokes.~   "
191413|NCT01058889|"~     The purpose of the study is to show if telemonitoring and automated feedback regarding~     glucose management, physical activity, blood pressure, and body weight improves treatment of~     patients with insulin dependent Type 2 Diabetes mellitus.~   "
191414|NCT01058876|"~     The investigators' general hypothesis is that African-Americans (AAs) smoke more for positive~     reinforcement from nicotine with a peak-seeking pattern of smoking (smoking individual~     cigarettes more intensively with greater intake of nicotine and tobacco smoke toxins), while~     whites smoke more for negative reinforcement with a trough-maintaining pattern (avoiding~     withdrawal by maintaining more consistent nicotine levels throughout the day by means of a~     more regular smoking pattern). We, the investigators, believe that these patterns are linked~     to identifiable racial differences in nicotine pharmacology.~      For this study we hypothesize that if AAs behave more like nicotine peak-seeker while~     whites behave more like nicotine trough-maintainers, that AAs will respond to switching~     from regular to low nicotine yield commercial cigarettes by smoking each cigarette relatively~     more intensively with a relatively smaller increase in daily cigarette consumption~     (cigarettes per day or CPD) as compared to whites.~   "
191415|NCT01058863|"~     This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to~     help adult and adolescent subjects 12 years of age and older with persistent asthma to~     improve lung function.~   "
191416|NCT01058850|"~     This is a research study of patients with diffuse intrinsic pontine gliomas. We hope to learn~     about the safety and efficacy of treating pediatric diffuse intrinsic pontine glioma patients~     with the EGFRvIII peptide vaccine after conventional radiation.~   "
191417|NCT01058837|"~     No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD)~     therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer~     than a few years. The NHLBI sponsored and placebo-controlled Sudden Cardiac Death in heart~     Failure Trial (SCD-HeFT) conducted from 1997 to 2003 had the largest number of patients and~     the longest average follow-up at 45.5 months. This study changed the national reimbursement~     policy for ICD therapy and remains the reference point for all other ICD evaluations in~     patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction.~     Despite the outcome, the role of ICD therapy in the management of patients with heart failure~     has been questioned because of four principal concerns: numbers needed to treat to save a~     life, lead integrity over time, the negative consequences of shock therapy, and the cost of~     therapy. The purpose of this trial is to track down the remaining patients for a one-time~     follow-up regarding key outcome data.~   "
191418|NCT01058824|"~     To assess the relative bioavailability of two different batches of Frademicina® drug product,~     containing 500 mg lincomycin hydrocloride, manufactured by Pfizer Laboratories Ltd. The~     formulations' comparative bioavailability after oral administration will be assessed based on~     the statistical comparisons of the relevant pharmacokinetic parameters, obtained from the~     drug concentrations in the blood. The lincomycin hydrocloride concentration will be measured~     by a proper and validated analytical method.~   "
191419|NCT01058811|"~     Try to find lung cancer stem cells from primary culture of routine surgical resection of lung~     cancer tissue including cancer cells and stroma cells, then characterization the established~     cell lines, and compare the difference of stroma cells between tumor part and surrounding~     part.~   "
191420|NCT01058798|"~     Neuroblastoma (NB) is the most common malignant tumor of infancy. Approximately 60% of NB~     patients are clinically diagnosed as the stage IV disease and have a very poor prognosis with~     a 5-year survival rate of no more than 30%. The mechanism underlying the tumorigenesis of NB~     remains largely unclear. It has been suggested that the pathogenesis of NB is due to a~     failure of differentiation or apoptosis of the embryonic NB cells.~      Well-regulated glycosylation is essential for the normal development of the nervous system.~     Altered expression of glycosyltransferases with resulting dysregulated glycosylation of~     neuroblastic cells might lead to the development of NB. The~     β1,4-N-acetylgalactosaminyltransferase III (B4GALNT3) exhibits GalNAc transferase activity to~     form the GalNAcβ1,4GlcNAc (LacdiNAc or LDN) structure. The Drosophila B4GALNTA, homolog of~     human B4GALNT3, has been suggested to regulate the neuronal development. By~     immunohistochemical studies, we demonstrated that the expression of B4GALNT3 correlated well~     with histological grade of differentiation in 87 NB tumor samples. In addition, positive~     B4GALNT3 expression predicted a favorable patient's outcome. These evidences suggest that the~     regulation of glycosyltransferases is critical for the development of NB.~      To further explore the role of glycosyltransferases in the differentiation and development of~     NB, we propose a 3-year project with the following 3 major aims:~      Aim Ⅰ: Clarifying the effects of B4GALNT3 on NB cell behavior in vitro and in vivo. For~     further understanding the effects of B4GALNT3 on NB cells, NB cells with stable~     overexpression of B4GALNT3 are to be selected. Then NB cell phenotype and behavior changes~     after overexpression of B4GALNT3 are evaluated by in vitro assays as well as by a nude mice~     xenograft model. In addition, the expression of B4GALNT3 will be suppressed by siRNA, then~     the response of NB cells to ATRA-induced differentiation is evaluated.~      Aim Ⅱ: Clarifying the target proteins glycosylated by B4GALNT3 as well as their associated~     downstream pathways in vitro and in vivo. The possible proteins glycosylated by B4GALNT3 are~     evaluated by comparing differential protein expressions between B4GALNT3-transfected and~     mock-transfected NB cells using proteomics analysis. NB tumor samples with low and high~     B4GALNT3 expression levels are also subjected to proteomics analysis to explore the possible~     target proteins glycosylated by B4GALNT3 in vivo. After identifying the target proteins~     modified by B4GALNT3, the downstream pathways to affect NB cell differentiation will also be~     evaluated.~      Aim Ⅲ: Clarifying whether B4GALNT4, a family member of B4GALNT, plays a similar role as~     B4GALNT3, as well as how the expression of these enzymes are controlled epigenetically in~     human NB cell lines and tumor samples. The expression levels of B4GALNT4 in human NB samples~     are evaluated by RT-PCR and immunohistochemistry. The methylation status of the promoter~     sites of both B4GALNT3 and B4GALNT4 are examined in various NB cell lines as well tumor~     samples. Furthermore, NB tumor samples exhibiting high and low B4GALNT levels are subjected~     to microRNA array.~      Altogether, our studies will not only establish the functional role of the family of~     glycosyltransferases in the cell behavior of NB, but also illustrate how the expression of~     glycosyltransferases are regulated epigenetically and how the glycosyltransferases affect NB~     cell behavior. Therefore, our results might shed light to the oncogenesis of NB as well as~     target therapy of NB.~   "
191439|NCT01058551|"~     Single site study: The goal of the study is to determine the incidence of new onset atrial~     fibrillation (AF) in patients with severe obstructive sleep apnea (OSA) syndrome through the~     use of a Medtronic Reveal XT implantable Loop recorder (ILR). The ILR device is approved for~     use in Canada, for the assessment of atrial fibrillation.~   "
191424|NCT01058746|"~     The purpose of this study is to help us learn what the best amount of fluid is that patients~     should receive during pancreas surgery. Patients will receive either the liberal fluid amount~     for this surgery or a restricted fluid amount.~      Both amounts of fluid have been used safely in patients having similar surgeries. These~     amounts have not been compared in pancreatic surgery. The fluids regimens that will be given~     are not experimental.~      This study will compare patients in the liberal and restricted fluid groups in terms of the~     nature of any surgical complications (problems)and recovery from surgery, including length of~     hospital stay.~   "
191425|NCT01058733|"~     Background~        -  Various kinds of interactive online communication systems have been introduced for~          long-term diabetes management, and their importance in managing patients is increasing.~          The investigators investigated the amount of physician time needed to maintain such a~          system, and the investigators developed software to maximise the cost effectiveness.~      Methods~        -  The investigators conducted a prospective, randomised, controlled trial to investigate~          the efficacy and safety of a semi-automatic response system (SARS) for online glucose~          monitoring over a 24-week period of patients with type 2 diabetes. In the SARS group,~          the SARS software filtered the recorded self-monitoring of blood glucose data~          automatically to reduce the physicians' time, and the physicians managed patients~          regularly but only manually in the control (manual) group. The investigators measured~          the time spent by the physicians for online management and compared the HbA1c levels at~          enrolment and follow-up.~   "
191426|NCT01058720|"~     The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal~     weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day.~   "
191427|NCT01058707|"~     This is a Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent~     MLN0128 in Subjects with Advanced Malignancies Followed by an Expansion in Subjects with~     renal cell carcinoma, endometrial cancer or urothelial cancer who have measurable disease~   "
191428|NCT01058694|"~     The purpose of proposed research is to implement a randomized study that will allow us to~     understand and address a number of key barriers to patient adherence as well as study the~     effects of better adherence on health and socio-economic outcomes.~   "
191429|NCT01058681|"~     This study will evaluate the potential effects of a changing metabolic environment on GnRH~     hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp~     studies) in different groups of male subjects fed isocaloric and hypercaloric diets. The~     participation of other gastro-intestinal tract hormones to these regulations will be~     systematically evaluated.~   "
191430|NCT01058668|"~     The objective of this study is to evaluate the efficacy, safety, and tolerability of~     cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes~     associated with bipolar I disorder.~   "
191431|NCT01058655|"~     Research has shown that anti-angiogenic agents can be effective therapies to treat cancer.~     Anti-angiogenic agents target the blood vessels required for tumors to grow. Vascular~     endothelial growth factor (VEGF) is one of the cell pathways used for this blood vessel~     growth. When the investigators interfere with the VEGF pathway, the investigators inhibit~     this blood vessel growth which is required by tumors. One of the study drugs being used,~     tivozanib (AV-951), selectively interferes with the VEGF pathway. The second study drug being~     used, everolimus (RAD001) interferes with the mTOR pathway. The mTOR pathway is another~     pathway involved in blood vessel and tumor cell growth. By combining these two drugs the~     investigators hope to slow or reverse tumor cell growth in patients whose tumors have become~     resistant to other therapies for their disease.~   "
191432|NCT01058642|"~     The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in~     participants with postherpetic neuralgia (PHN). The secondary objective of this study is to~     evaluate the safety, tolerability, and pharmacokinetics of ADL5747.~   "
191433|NCT01058629|"~     This is a multicenter study to evaluate the clinical performance of the SynergEyes A2 lens in~     patients with refractive errors with or without astigmatism.~   "
191434|NCT01058616|"~     The study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect~     in animal models to kill cancer tumours when injected directly in to the tumour. The study~     will also monitor the immunological response in the body after injection of LTX-315.~   "
191435|NCT01058603|"~     The aim of this study is to demonstrate the efficacy of a single embryo transfer at~     blastocyst stage (Day 5) after co-culture on Autologous Endometrial Cell Culture (AECC)~     versus transfer of a single embryo at Day 3 after culture in conventional medium. Efficacy~     will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.~   "
191436|NCT01058590|"~     Obstructive sleep apnea syndrome (OSAS) is a common disorder in children (2-3%). OSAS in~     turn, is associated with significant behavioral, learning, and heart problems.~     Adenotonsillectomy (T&A, meaning the removal of tonsils and adenoids) is the most common~     treatment for the problem .Diagnosis of OSAS in children is based on overnight~     polysomnography (sleep study). Recent studies suggest that upper airway and systemic~     inflammatory changes exists in school-age children and adults with OSAS, and that anti~     inflammatory therapy can improve respiratory parameters during sleep and reduce adenoid size,~     similar to surgery. However, there are no data in the literature on inflammatory changes in~     infants with the disorder.~      Healthcare resources utilization, a sensitive marker for diseases is consumed by young~     children (<3y) with OSAS more then healthy children, from their first year of life We~     hypothesize that infants and young children with OSAS present local inflammatory changes of~     the airways as well as systemic inflammation (in the blood or urine) that contribute to the~     learning, growing and heart associated medical problems. The Aims of the present study are to~     characterize the local and systemic inflammatory changes of young children with OSAS, and to~     evaluate their associated medical problems at diagnosis and after therapy (T&A) If indeed~     inflammation is responsible for the development of OSAS at such a young age it should be~     reduced following therapy (i.e. T&A). In such a case bio-markers may become a part of the~     algorithms for diagnosis and follow up of such patients.~   "
191437|NCT01058577|"~     In healthy subjects: Continuous monitoring of the glucose concentration in the skin by means~     of a non-invasive glucose sensor during a glucose clamp when systematically changing the~     blood glucose concentration (e.g. to hyperglycemia). Simultaneous frequent determinations of~     serum electrolytes.~   "
191438|NCT01058564|"~     Evaluate a novel method of augmenting a weak Lower Esophageal Sphincter (LES).~   "
191440|NCT01058538|"~     This is a Phase I/II study for patients with solid tumors and renal cell carcinoma (RCC; for~     the Phase II part). L19-IL2 is a tumor targeted immunocytokine constituted of a single chain~     Fragment variable (scFv) format directed against the ED-B domain of fibronectin, one of the~     most important markers for neoangiogenesis, and the human cytokine interleukin-2 (IL2).~   "
191441|NCT01058525|"~     The real-time visualization of a needle and nerve during an ultrasound-guided nerve block can~     be challenging. These difficulties may partly explain the systemic complications of local~     anesthetics under ultrasound. Injection of small amounts of a solution around the~     anesthetized nerve (hydro-dissection) has been proposed to enhance contrast outlining its~     borders and also to improve the visualization of the needle tip. The glucose solution 5%~     solution is interesting because it allows, unlike saline, to maintain the motor response with~     neurostimulation. The hydro-dissection can be particularly useful when one suspect hypoechoic~     vessels near the nerve to be anesthetized. Thereby, the nerve well demarcated and separated~     from the vessels, injection of local anesthetic is performed in the circumferential diffusion~     space (like a small pocket) without redirecting needle.~      The influence of this hydro-dissection on the nerve block efficiency is unknown. The nerve~     block quality can be improved because the entire anesthetic is injected in contact with the~     nerve, but it can also be reduced due to the dilution of the local anesthetic by the glucose~     solution.~      In this randomized study, the investigators test the hypothesis that hydro-dissection does~     not alter the nerve block onset time.~   "
191442|NCT01058512|"~     The purpose of this research study is to find out the effect of the investigational drug~     NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated~     at different doses when taken by subjects with hepatitis C.~   "
191443|NCT01058499|"~     The objective of this study is to test the efficacy of a Mindfulness Based Stress Reduction~     program in COPD on quality of life, dyspnea, daily physical activity and mindfulness during~     daily life.~   "
191444|NCT01058486|"~     The investigators' proposed study is a randomized controlled trial that will prospectively~     examine the effect of a multicomponent intervention on the rate of hospitalizations, daily~     physical activity, self efficacy and health status in patients who have COPD and have been~     hospitalized because of a COPD exacerbation.~      In the study, a convenience sample of patients recently hospitalized for a COPD exacerbation,~     who meet the selection criteria and agree to participate will be randomized to receive one of~     the following at the time of hospital discharge: (1) the current standard of care plus a~     multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the current~     standard of care without the intervention.~      This study plans to test the following hypotheses: (1) The primary outcome of the study to be~     the composite endpoint of death or COPD hospitalization (2) Time to first rehospitalization~     will be shorter in the intervention group than the control group (3) At follow-up, the~     physical activity level measured in terms of the average number of steps and active energy~     expenditure will be higher in the intervention group than in the control group.~   "
191445|NCT01058473|"~     Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of~     its recurrent nature. Patients with sickle cell disease may be hospitalized for extended~     periods of time. As the hospital stay progresses, patients with SCD pain are often observed~     by clinicians to have improvements in function in areas such as self-care, mobility, and~     recreation despite continued self-report of high pain scores. This pattern of functional~     improvement with continued report of high pain intensity scores is common in patients with~     recurrent and chronic pain. A functional assessment tool that can assess function in the~     acute inpatient setting is needed.~      The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity~     Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease~     hospitalized with vasoocclusive pain.~   "
191446|NCT01058460|"~     To compare the effects of conventional cytology testing with concommitant HPV-cytology~     testing for the detection of high grade cervical lesions in primary cervical cancer screening~     in Hong Kong~      Hypotheses:~        1. There is a significant difference in the number of CIN2+ cases detected between the~          cytology testing group and the cytology-HPV co-testing group at baseline.~        2. Significantly more CIN2+ cases will be detected at the second round of screening among~          participants with normal cytology result in the control arm than those with normal~          cytology and negative HPV results in the intervention arm.~   "
191447|NCT01058447|"~     The purpose of the study is to characterize the absorption, distribution, metabolism and~     excretion (ADME) of a single oral dose of [14C]AZD1981~   "
191448|NCT01058434|"~     This study will evaluate safety and efficacy of TKI258 in patients with relapsed or~     refractory multiple myeloma~   "
191449|NCT01058421|"~     Acute respiratory failure is a heterogeneous disorder that results in more than 300,000~     Americans requiring admission to an intensive care unit for invasive mechanical ventilatory~     support each year. Though acute respiratory failure is a pulmonary disorder, patients who~     survive their hospitalization are not limited by respiratory symptoms after discharge. Rather~     persistent neuromuscular weakness is the primary disorder that adversely alters their quality~     of life and ability to function on a daily basis. In this application the investigators plan~     to conduct a randomized clinical trial called the Do It Now study (Diagnosis and Treatment of~     Neuromuscular Weakness) to determine the effectiveness of an intensive physical therapy~     program for patients recovering from acute respiratory failure. This trial will establish the~     efficacy of the physical therapy programs that is currently performed for patients with acute~     respiratory failure in a non-evidence based manner across the United States.~   "
191450|NCT01058408|"~     RAD001 is approved by the U.S Food and Drug Administration (FDA) to treat advanced kidney~     cancer. This drug has also been used in other research studies to evaluate its effectiveness~     in other cancers. Information from these research studies suggests that RAD001 may help to~     decrease the growth and development of tumor cells by reducing the blood supply that tumors~     need to grow. In this research study, we are trying to determine the safety of RAD001 when~     given to people with locally advanced head and neck cancer in combination with cisplatin and~     radiation. We are also looking for the highest dose of RAD001 that can be given to people~     safely.~   "
191624|NCT01056133|"~     The purpose of this study is to determine the effect of Omega-3 Fish oil supplementation on~     hepatic gene expression in patients with Non Alcoholic Steatohepatitis (NASH). In addition,~     effects of fish oil on intestinal microbiota will be assessed.~   "
191451|NCT01058395|"~     The purpose of this study is:~        1. To assess the safety and feasibility of minocycline administration after TBI in a dose~          escalation study at two different doses over 7 days.~        2. To assess the pharmacokinetic characteristics of two different dosing regimens of~          minocycline in TBI patients, the effect on biochemical markers of neuroprotective~          mechanisms, and effect on neurobehavioral and functional outcome.~        3. To begin initial assessment of the efficacy of minocycline as a therapeutic agent for~          severe human TBI.~   "
191452|NCT01058382|"~     There have been two very common forms of progesterone administration that have been used~     during ovulation induction, in vitro fertilization (IVF) and embryo transfers. There are~     currently no randomized clinical trials to demonstrate which method of progesterone~     administration is more effective for frozen embryo transfer. We raise the question: Is there~     a difference between the two accepted methods of progesterone administration, intramuscular~     and vaginal suppositories, for frozen embryo transfer? Studies for fresh embryo transfer~     after in vitro fertilization, have demonstrated that there is not a difference between the~     two methods of progesterone administration. We will evaluate the question for frozen embryo~     transfer.~   "
191453|NCT01058369|"~     Study outline: Deferasirox (Exjade®) is regularly used in severe iron overload in order to~     avoid organ damage of liver, heart and other organs. It has been proposed, that iron overload~     may not only impose damage to other organs but also to the bone marrow and thus worsen~     hematopoietic insufficiency in patients with MDS. Patients presenting with low or INT-1 risk~     MDS with only mild iron overload will be treated with deferasirox in this study. It will be~     analyzed if hematological improvement can be observed during this treatment.~   "
191454|NCT01058356|"~     Antibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The~     frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is~     relatively infrequent in outpatients. The risk factors for AAD include broad-spectrum~     antibiotics, host factors (age, health status, and gender), hospitalization period and~     exposure to nosocomial pathogens. AAD occurs 2-8 weeks after exposure to antibiotics as a~     result of disrupting normal intestinal microflora. One of the roles of normal intestinal~     microflora is to act as a protective barrier that resists the colonization of intestinal~     pathogens. These patients are susceptible to infection by opportunistic pathogens without~     this protective barrier. Probiotic therapy is suited to AAD and Clostridium difficile~     disease. Probiotics assist in reestablishing the disrupted intestinal microflora, enhancing~     immune responses and clearing pathogens and their toxins from the host. Studies using~     probiotics have been reported for the past twenty-eight years (1977~2005), but the studies~     have been variable in trial designs and types of probiotics, had differing doses and~     durations of treatment, and thus have yielded controversial results. The investigators will~     conduct a multi-center, randomized, placebo-controlled, double-blind trial to assess the~     efficacy of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults.~   "
191455|NCT01058343|"~     Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus~     (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be~     an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a~     polyclonal antibody response.~      This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will~     also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE~     disease.~   "
191456|NCT01058330|"~     A physical training program will improve quality of life, participation in physical activity,~     motor coordination, muscle strength, and bone and muscle strength in children with~     neurofibromatosis type 1.~   "
191457|NCT01058317|"~     Juvenile onset recurrent respiratory papillomatosis (JORRP) is a rare, difficult to treat,~     benign tumor of the pediatric airway. Current therapy is mainly surgical, but in a~     significant portion of patients adjuvant therapy is required to control the disease process.~     Although multiple adjuvant medical therapies have been tried, success has been limited. We~     have seen some success in a limited amount of patients using orally administered propranolol.~     Our goal is to enroll a larger cohort of patients to determine the effectiveness of~     propranolol as an adjuvant therapy for JORRP.~   "
191458|NCT01058304|"~     Pain management is a priority for the Department of Veterans Affairs (VA) health care system,~     and knee osteoarthritis (OA) is a main cause of chronic pain. Veterans who receive care~     within the VA health care system have higher rates and more severe OA than both the general~     population of adults and veterans who receive health care elsewhere. Physical therapy (PT) is~     a primary part of treatment for knee OA, but in the VA health care system PT appointments are~     a limited resource, and veterans often do not receive enough visits to promote long-term~     improvements in pain and physical function. New models of delivery, such as the group-based~     approach examined in this study, are needed to expand PT services in a cost-effective manner.~   "
191459|NCT01058291|"~     This is a placebo-controlled double-blind crossover comparative study of KW-6500 in~     Parkinson's disease patients with motor response complications on levodopa therapy. The~     efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind~     period after 12 weeks subcutaneous self-injections.~   "
191460|NCT01058278|"~     The present study's main objective is to assess if there is a significant difference between~     either of the treatments frequently used in post-op, namely a topic cortisone-based~     treatment, an non-steroidal anti-inflammatory drug (NSAID) or simply a placebo, in order to~     gain the best long term (6 months) efficacy of the SLT.~   "
191461|NCT01058265|"~     Patients with a diagnosis of chronic fatigue or pain benefit minimally from a conventional~     medical evaluation yet consume a large amount of medical resources and time. The question is~     to see if patients with a diagnosis of chronic pain or fatigue benefit from an Integrative~     Medicine medical evaluation conducted by physician who has additional training in Integrative~     Medicine. Patients who call for a general medical examination with a complaint of chronic~     fatigue or pain will be set up with the integrative medical specialist or standard general~     medical evaluation.~   "
191462|NCT01058252|"~     The purpose of this study to evaluate a low cost minimal stimulation protocol combined with~     Intravaginal Culturing, to make IVF affordable and available across the large~     infertile/subfertile population~   "
191625|NCT01056120|"~     To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent~     system in a patient population within that defined in the Instructions for Use.~   "
191463|NCT01058239|"~     Post transplant lymphoproliferative disease (PTLD) is a type of B-cell non-Hodgkin lymphoma~     that occurs in patients with weakened immune systems due to immunosuppressive medications~     taken after organ or stem cell transplantation. This is usually related to a virus called~     Epstein-Barr (EPV). Rituximab is a type of drug called an antibody that specifically~     destroys both normal and cancerous B-cells, and is commonly used for PTLD. Bortezomib is a~     drug that has been approved by the Food and Drug Administration (FDA) to treat multiple~     myeloma and a B-cell non-Hodgkin lymphoma called Mantle Cell Lymphoma, and shows significant~     activity in lymphoma cells caused by EBV. In this research study, we hope to learn if the~     addition of bortezomib to rituximab treatment can increase the rate of complete remissions~     and cures of PTLD after organ or stem cell transplant.~   "
191464|NCT01058226|"~     This is a prospective, single arm, single intervention safety and immunogenicity study in 6~     healthy, malaria-naive adults, conducted to demonstrate the successful implementation of the~     well-established malaria challenge model at the Seattle Biomedical Research Institute~     (Seattle BioMed).~   "
191465|NCT01058213|"~     This is a 16 week exercise training program for people with severe to very severe chronic~     obstructive pulmonary disease (COPD). The purpose of this study is to find out if performing~     strength training prior to initiating exercise training on a stationary bicycle is associated~     with greater gains in functional status than bicycle training alone or concurrent bicycle and~     strength training together.~   "
191466|NCT01058200|"~     The hypothesis is that the new vacuum assisted delivery device iCup is more effective than~     the reference cup, in terms of maternal and newborn morbidities and functioning~   "
191467|NCT01058187|"~     To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming~     infant formulas containing differing levels of fatty acids~   "
191468|NCT01058174|"~     Prevention of invasive fungal infection in high risk patients following liver transplant.~   "
191469|NCT01058161|"~     The present project aims at evaluating the diagnostic potential of high-field MRI (3 Teslas)~     for joint disease. At this field, given that isotropic image resolution of 400 microns can be~     obtained, one could expect an early detection of joint abnormalities. The additional aim of~     this project will be to develop a quantitative analyse of the corresponding high-resolution~     images.~   "
191470|NCT01058148|"~     Background:~        -  The Mississippi Delta (which includes the counties along the Mississippi River) is one~          of the poorest areas in the United States. Women living in the Mississippi Delta have~          disproportionately high rates of cervical cancer, but they are unlikely to come to~          clinics except perhaps for giving birth, years before they are diagnosed with cancer.~        -  To improve rates of screening, researchers are attempting an outreach study to see~          whether under-screened women, if approached by door-to-door recruitment, would get~          screened by one of two methods (home-based self-collection and testing, or a clinic~          exam) and which method they would prefer.~      Objectives:~      - To assess/measure increased participation of under-screened women living in the Mississippi~     Delta in cervical cancer screening by offering women the opportunity to get screened by one~     of two possible community outreach-based cervical cancer screening modalities,~     self-collection and HPV testing or clinic-based cytology screening, the current standard of~     care.~      Eligibility:~      - Women between 26 and 65 years of age, who are not pregnant currently or in the past 8~     weeks, have an intact cervix, have no history of cancer, and have not been screened for~     cervical cancer in the past 3 years.~      Design:~        -  Researchers will recruit participants on a door-to-door basis. Researchers will recruit~          all eligible women within a household. Recruitment will be done only during daylight~          hours but at the end of the working day to maximize the chances of finding women at~          home.~        -  Eligible women willing to participate will complete a questionnaire with demographic and~          medical information.~        -  Participants will be asked to choose the screening method of their preference. If they~          choose self-collection with HPV testing, they will be given a self-collection kit and~          asked to perform the self-collection and return the kit within 1 month. Participants who~          choose to have cytology screening will be provided with the phone number and location of~          the local health department clinic and will be encouraged to schedule their screening~          within the following month.~        -  Women who do not complete their participation within 1 month will be considered~          noncompliant with their chosen intervention. Researchers will re-contact noncompliant~          women to offer them participation in the study, including permitting them to refuse to~          participate or to choose the alternative intervention....~   "
191471|NCT01058135|"~     The purpose of this study is to determine the effects of a dietary fiber, resistant starch,~     on insulin sensitivity. Low insulin sensitivity is a risk factor for some diseases including~     type 2 diabetes and heart disease. This study will show if consuming resistant starch can~     help improve insulin sensitivity in overweight and obese people.~   "
191472|NCT01058122|"~     The proposed cohort study collected within a 5-month observation period adverse drug reaction~     (Adverse Drug Events - ADE) in patients at the Department of Oncology at the University of~     Zurich. ADE have been recorded using prospective monitoring and assessed using standardized~     algorithms regarding causality and severity. Data sources included information from the~     medical records, laboratory values and internal rounds. Additional information has been~     collected using a standardized patient questionnaire.~      The primary endpoints of this study are to determine the frequency of ADE, the comparison of~     the quality of data sources and collection methods for the detection of ADE in regard to~     patient characteristics, size, number of medications, the category of ADE, severity,~     causation, diagnosis, hospitalization, cause of hospitalization and medication cause.~     Secondary endpoint is the assessment of the ADE causality, severity and predictability.~   "
191473|NCT01058109|"~     The aim of this experimental study was to test the effect of increasing dietary calcium~     intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to~     be tested is: adolescent females who consume a high calcium diet will have a greater increase~     in bone quality, as measured by densitometry and ultrasound, than adolescent females who~     consume their usual dietary calcium intake.~   "
191474|NCT01058096|"~     The objective of this study is to evaluate the efficacy, safety, and tolerability of~     cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes~     associated with bipolar I disorder.~   "
191475|NCT01058083|"~     The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects~     on LDL cholesterol (LDL-C)~   "
191476|NCT01058070|"~     Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function~     in the treatment of Gastroesophageal Reflux Disease (GERD)~   "
191477|NCT01058057|"~     This study investigates potential protective effect of atorvastatin pre-treatment in patient~     with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) on~     chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment~     group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin~     pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by~     troponin I and creatine kinase myocardial band.~   "
191557|NCT01057004|"~     EVITA should function as an idea supplier and should coordinate possible future studies.~     Other important tasks of the register are: (i) the establishment of recommendations for an~     optimal medicinal therapy (OMT) as well as for ICD- and CRT-treatment; (ii) the establishment~     of quality assurance measures, including monitoring of new therapy.~   "
191478|NCT01058044|"~     The purpose of this study is to describe adherence to 3 oral anticancer treatment: i) a~     chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or~     sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor.~     Moreover, this study is aimed at evaluating the feasibility to use a  Medication Event~     Monitoring System  (MEMS®) in order to assess adherence of an oral anticancer treatment~     delivered by dispensary pharmacy.~   "
191479|NCT01058031|"~     The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive~     therapy control group.~   "
191480|NCT01058018|"~     The purpose of this study is to investigate dose range, safety and efficacy of RVX000222 in~     subjects with stable coronary artery disease.~   "
191481|NCT01058005|"~     This was a multicenter, randomized, open-label, parallel-group, active-controlled study.~     Prior to randomization, participants were to have been treated with glatiramer acetate or~     interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab,~     interferon β-1a 44 μg, or glatiramer acetate.~   "
191482|NCT01057992|"~     A medical device to augment weak lower esophageal sphincter function.~   "
191483|NCT01057979|"~     Engagement in substance-free activities, such as exercise, has an inverse relationship to~     substance use in college students. While exercise has numerous physical and mental health~     benefits, the majority of college students are sedentary, infrequently engaging in exercise.~     Although exercise interventions to date often suffer from significant attrition and poor~     adherence, motivational interventions for exercise are beginning to show promise. In this~     pilot study we propose to develop and evaluate a novel exercise intervention combining~     Motivational Enhancement Therapy (MET) with contingency management (CM) in sedentary college~     students who use alcohol.~   "
191484|NCT01057966|"~     This study is a comparison of the bioavailability of nutrients contained in softgel capsules~     vs tablets.~   "
191485|NCT01057953|"~     The majority of the clinical situations suggestive of an increased genetic risk for~     colorectal cancer (CRC) are not explained by a simple monogenic model. Our working hypothesis~     is that a fraction of clinical conditions suggestive of an increased genetic risk for CRC~     (familial aggregation, early age of tumour onset, development of multiple primary CRC) is due~     to the combination of a limited number of genetic variations, each conferring a moderate risk~     for CRC, but whose combination results into high risk.~      This study, which will be both retrospective and prospective, is an association study that~     will compare frequencies of selected genetic variations, alone or in combination, between~     patients (cases) whose clinical presentation is suggestive of an increased genetic risk but~     who do not present a known Mendelian form of CRC, and controls, in order to assess~     associations of these variations with non-Mendelian genetic forms of CRC. The inclusion~     criteria will be: CRC in two first degree relatives, one being diagnosed before 61 years of~     age; or CRC diagnosed before 51 years of age or advanced colorectal adenoma before 41 years~     of age; or multiple primary CRCs in the same individual, the first being diagnosed before 61~     years of age The exclusion criteria will be: Lynch syndrome, adenomatous polyposis and~     hamartomatous polyposis. The genetic variations which will be analyzed will include (i) SNPs~     detected by GWAS and associated to CRC. (ii) Risk factors corresponding to functional~     polymorphisms within candidate genes. (iii) Imbalance of the TGFbR1 allelic expression.~     Sample sizes were calculated to obtain 80% power for an odds ratio of 2.5 since the aim of~     this study is to determine genetic variations conferring a moderate risk. In order to cover~     all these possibilities and to have reasonable even for the genetic variations with low~     frequency below 0.03 or high frequency above 0.90, the target sample size was set at 700~     cases and 350 controls. The recruitment of patients will be performed at the national level~     by the cancer genetics departments ensuring a correct evaluation of the personal and familial~     history and the French molecular diagnosis laboratories network ensuring in routine the~     analysis of the main genes involved in CRC. The control population will be composed of~     healthy subjects of Caucasian origin between 45 and 60 years of age, without personal or~     familial history among their first-degree relatives of colorectal tumours.~      Demonstration that the combination of a limited number of genetic variations, each conferring~     a moderate risk for CRC, results into high risk would allow to base, in selected families,~     the evaluation of risk in relatives and indication of colonoscopy on the analysis of gene~     variants the combination of which would confer a high risk. This study will confirm or~     invalidate the contribution of aTGFbR1 allelic expression imbalance in the determinism of~     early-onset CRC and familial aggregation of CRC. The demonstration of the involvement in CRC~     genetic variations with strong effect of specific combinations should be of interest for our~     general understanding of the molecular basis of CRC.~   "
191486|NCT01057940|"~     Is DBE(double balloon enteroscopy)-assisted DPEJ(direct percutaneous endoscopic jejunostomy)~     a viable option in patients who have failed conventional DPEJ placement and who otherwise~     would require surgical jejunostomy or parenteral nutrition.~   "
191487|NCT01057927|"~     The purpose of the study is to investigate the clinical effects of multiple (28 day)~     twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild~     to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting~     inhaled B2-adrenergic agonists for symptomatic control.~   "
191488|NCT01057914|"~     The purpose of this study is to evaluate the effects of nutritional therapy in elderly~     malnourished patients. The hypothesises are that nutritional supplementation and dietary~     advice alone or in combination affects mortality, quality of life and health-care consumption~     after six month of treatment.~   "
191489|NCT01057901|"~     The objective of this trial is to assess the safety and efficacy of 24-week course of~     flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally~     postmenopausal women.~   "
191490|NCT01057888|"~     The investigators will design and implement a randomized clinical trial to test, on a~     community-wide level, the effectiveness of managed care based tracking/reminder/recall on~     improving vaccination coverage among adolescents.~      The investigators propose a randomized controlled trial to evaluate the effectiveness of~     reminder/recall for adolescents: 10,599 adolescents within the managed care organization~     (MCO) will be randomized into one of three arms: 1) mailed reminders, 2) autodialer telephone~     messages or 3) standard of care of their practice (no messages from the intervention).~      Hypothesis 1: Reminder/recall will increase the receipt of immunizations and preventive~     services~      Hypothesis 2: Telephone (autodialer) reminders will be more effective than mailed reminders~      Hypothesis 3: The impact of reminders will be greatest for the most high-risk subgroups which~     have low baseline immunization rates.~      Hypothesis 4: Mailed reminders will be more costly (and less effective) than telephone~     reminders.~   "
191491|NCT01057875|"~     To investigate whether or not the ingestion of caffeine with alter airway responsiveness to~     methacholine and/or change the level of exhaled nitric oxide.~   "
191492|NCT01057862|"~     The investigators plan to investigate the safety, tolerability, and efficacy of the opioid~     antagonist naltrexone in Pathological Gambling. We hypothesize that naltrexone will be~     superior to placebo in reducing gambling urges and behavior, when combined with adjuvant~     non-pharmacological treatment as usual.~   "
191553|NCT01057056|"~     Background: The main goal of geriatric rehabilitation reconditioning following an acute~     illness is rapid restoration of normal activity. Key elements are pain control, restoration~     of bowel functions, sleep, appetite and general well-being, along side the physical activity.~      Objective: To assess the effect of mind-body intervention as an adjunct to medical and~     physical rehabilitation in geriatric patients.~      Design: Prospective study Setting: University affiliated large city general hospital~   "
191493|NCT01057849|"~     Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical~     antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase~     are all better than typicals, individulized regimen of them for first-episode schizophrenia~     and their effectiveness in real naturalistic clinical settings still remain unclear. And~     those patients also need more comprehensive intervention such as psychosocial programs to~     improve their function. This protocol is to conduct a study in several sites of China to~     investigate the effectiveness of comprehensive intervention combining sequenced atypical~     antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic~     patients. In addition, this protocol also aims at collecting such information as molecular~     genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.~   "
191494|NCT01057836|"~     The purpose of this study is to determine whether intensive one-year neck strength training~     can enhance health related quality of life in females with chronic neck pain.~   "
191495|NCT01057823|"~     The overall goal of this research is to elucidate how environmental, healthcare, and~     patient-level factors and patients' level of perceived control impact sleep duration and~     quality in hospitalized older patients and to assess whether better in-hospital sleep is~     associated with improved physical activity and health outcomes.~      We hypothesize that environment, healthcare disruptions and patient symptoms will be~     significantly associated with objective and subjective sleep duration and sleep quality in~     hospitalized older patients.~      We also hypothesize that a high level of perceived control will be associated with improved~     sleep duration and quality in hospitalized older patients.~      We further hypothesize that shorter sleep duration and quality in hospitalized older adults~     will be associated with adverse health outcomes, namely higher blood pressure and blood~     sugar.~   "
191496|NCT01057810|"~     The purpose of this study is to determine if asymptomatic or minimally symptomatic patients~     with metastatic prostate cancer who have not received chemotherapy live longer when treated~     with ipilimumab than those treated with a placebo~   "
191497|NCT01057797|"~     This is a four month exercise training program for people with chronic obstructive pulmonary~     disease (COPD)with a 12 month follow-up.~   "
191498|NCT01057784|"~     The UCLA Metabolic and Bariatric Surgery Program (adult program) and the UCLA Fit for Healthy~     Weight Program (adolescent program) are committed to the care of morbidly obese patients.~     This study is observational. The investigators plan to evaluate bariatric surgery outcomes~     using the BAROS National Database and also to evaluate quality of life pre- and post~     bariatric surgery. In addition, the investigators plan to enroll a subgroup of 10~     reproductive-age women to evaluate: 1) pregnancy and offspring health, 2) long-term~     nutrition, 3) biomarkers/epigenome, and 4) body-composition/bone-density.~   "
191499|NCT01057771|"~     The overarching goal of this project is to determine whether mind-body practices such as~     meditation or exercise can reduce the public health burden of acute respiratory infection. A~     major secondary goal is to determine whether mindfulness meditation or moderately strenuous~     exercise can enhance immune processes such as antibody response to influenza vaccination (flu~     shots). Finally, we want to investigate the influence of stress, optimism, anxiety and~     positive and negative emotion on immunity and resistance to respiratory infection.~   "
191500|NCT01057758|"~     The objective is to assess the efficacy and safety of oral simvastatin in patients with a~     suspicion of ventilator-associated pneumonia (VAP). The hypothesis of this study is that~     simvastatin therapy will improve mortality in patients a suspicion of VAP.~   "
191501|NCT01057745|"~     Women of reproductive age who will undergo cancer treatment may participate in a study to~     surgically remove ovarian tissue and store it, frozen, for their potential use in the future.~     20% of collected tissue will be used for research.~   "
191502|NCT01057732|"~     Primary hyperparathyroidism (PHPT) is associated with increased cardiovascular morbidity. The~     benefit of surgical treatment in this respect is unclear.~      This study was performed to evaluate the impact of parathyroidectomy (PTX) on cardiovascular~     risk profile.~   "
191503|NCT01057719|"~     The aim of the study was to compare the effect of inpatient physiotherapy in a warm climate~     versus physiotherapy in a colder climate in multiple sclerosis (MS), in both short- and long~     term perspectives.~   "
191504|NCT01057706|"~     This study will compare the effectiveness of chiropractic and exercise treatment in the~     short- and long-term, when managing chronic neck and back disability in seniors over the age~     of 65 years.~   "
191505|NCT01057693|"~     Patients will be switched from their current medication for painful diabetic peripheral~     neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All~     patients will receive pregabalin, and half of patients will receive placebo at some point~     during the study.~   "
191506|NCT01057680|"~     As we age, we experience a reduction in muscle and bone which inevitably decreases strength~     and the ability to perform tasks of daily living such as gardening, carrying groceries, and~     climbing stairs. Health costs associated with aging muscle and bone loss are in the billions~     of dollars. With the projected increase in life expectancy, the incidence of muscle and bone~     loss will rise and further drain the healthcare system, with greater need for~     hospitalization, treatment, and rehabilitation. Without effective strategies to counteract~     aging muscle and bone loss, we may face a healthcare crisis in the future. Creatine, a~     compound found in red meat and seafood, increases creatine phosphate stores in muscle,~     providing increased energy during high-intensity exercise. Short-term (i.e. 3-4 months)~     resistance-exercise and supplementation with creatine, have been shown to have a favorable~     effect on properties of aging muscle and bone. However, the longer-term (i.e. 1 year) effects~     of these interventions are unknown. Therefore, the purpose of this innovative research is to~     determine the longer-term effects of resistance-exercise and creatine supplementation~     (0.1g•kg-1) in older adults. The primary dependent variables to be assessed will include~     muscle hypertrophy, bone mineral and bone geometry, strength, and urinary and blood~     indicators of liver and kidney function. This innovative, multidisciplinary research will~     help contribute to the successful pursuit of prolonged independent living by improving aging~     musculoskeletal health for older Saskatchewan adults. Saskatchewan provides a relevant~     setting for this research, given the higher percentage of older adults (15%), compared to the~     national average (12%).~      We hypothesize that creatine supplementation will increase muscle mass, strength, and bone~     mineral density more than placebo.~   "
191531|NCT01057355|"~     Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual~     treatment of these cysts is either observation or surgical removal of part or all of the~     pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic~     ultrasound (EUS) guided ethanol injections. Such studies exclude cysts that communicate with~     the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. In this~     study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via~     endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.~   "
191507|NCT01057667|"~     This equally randomized (1:1), double-blind, parallel arm study will assess the safety and~     antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus~     Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in~     arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys~     (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a~     rapid virological response (RVR) at week 4, sustained through week 22, will stop all~     treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for~     another 24 weeks up to week 48. Patients in arm B will receive standard treatment with~     Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.~     Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.~   "
191508|NCT01057654|"~     Lifibrol is a new lipid-lowering drug which lowers cholesterol to an extent in the order of~     magnitude of the statins. The mechanism of action of this compound is different from the one~     of statins but remains unknown. The current study will investigate the mechanism of action~     using stable-isotope turnover methods. The study will be done in healthy male volunteers.~   "
191509|NCT01057641|"~     Neurogenic intermittent claudication is a specific symptom complex occurring in patients with~     lumbar spinal stenosis. Characteristic of this disease is the occurrence of increasing leg,~     buttock or groin pain with or without lower back pain when walking a certain distance or~     reclining. Bending forward or sitting leads to a rapid pain relief. Lumbar spinal stenosis is~     defined as a reduction of the diameter of the spinal canal. The mechanism leading to stenosis~     is a remodeling and overgrowth of the spinal canal with osteophyte formation. Any loss of~     tissue or decrease of the disc height results in a relative laxity of the ligament structures~     and accelerates the degeneration of the spinal joints. As a therapy option, conservative~     therapy with oral analgesics and physical therapy is considered. This treatment can be~     intensified by adding epidural pain treatment. Is the conservative treatment not successful~     surgical intervention is necessary. In patients over 65 years of age operative decompression~     of the lumbar spinal stenosis constitutes the most common surgical operation of the spine. A~     relatively new therapy alternative is the interspinous process decompression (IPD). Studies~     have shown that the IPDs prevent narrowing of the spinal canal and neural foramens. The study~     is intended as a randomised, monocentre study to investigate the safety and the benefit of a~     minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative~     treatment of lumbar spinal stenosis.~   "
191510|NCT01057628|"~     This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients~     with type 2 diabetes mellitus.~   "
191511|NCT01057615|"~     Combining fish oil and vitamin C supplementation will provide a greater anti-inflammatory~     effect against developing exercise-induced bronchoconstriction (EIB) than either nutritional~     supplement alone.~   "
191512|NCT01057602|"~     The purpose of this study is to apply a recently developed screening test for dementia, the~     Memory Orientation Screening Test (MOST) to two additional groups. Group one is composed of~     150 elders who do not have dementia and are residing in the community so that we can~     determine what is a normal MOST score. These subjects will also be individually~     administered a one-hour battery composed of other commonly used tests of memory and~     information processing. Group two is composed of 150 elders who are administered the MOST by~     a nurse as part of their regular visit to the primary care doctor's office, and their scores~     will be compared against a rating of their cognitive ability made independently by the doctor~     or another nurse. Their scores will also be compared with a list of their medical problems~     and medications. Our hypothesis for the first group is that the MOST scores will be higher in~     the normal group than in the previous clinical groups and that MOST scores will correlate~     significantly with other neurocognitive tests. Our hypothesis for the second group is that~     the MOST can be administered quickly and easily by briefly trained nurses, that it will~     compare highly with doctor opinions, and that patients with known medical conditions related~     to dementia, such as hypertension or diabetes, will have lower MOST scores than patients in~     better health.~   "
191513|NCT01057589|"~     The purpose of this trial is to estimate progression free survival in patients with recurrent~     or metastatic head and neck cancer that have not received chemotherapy in this setting.~   "
191514|NCT01057576|"~     Specific compounds in plants have been proposed to enhance human metabolism. The hypothesis~     of the study was to evaluated the effect of an extract of Russian tarragon and to determine~     is compounds in the plant can be measured in the serum of human subjects and whether the~     compound may improve human metabolism as suggested in animal studies.~   "
191515|NCT01057563|"~     Restenosis due to neointimal hyperplasia causes repeat target vessel revascularization in a~     relevant number of patients undergoing percutaneous coronary interventions (PCI).~     Drug-eluting stents (DES) are currently adopted to reduce the rate of restenosis; however,~     they may increase risk of stent thrombosis.~      Experimental data and first clinical experiences showed that inhibition of neointimal~     hyperplasia may be obtained by local administration of anti-proliferative drugs (like~     paclitaxel) loaded on the surface of angioplasty balloons. Data on the efficacy of novel~     coronary drug-eluting balloons (DEBs) are lacking.~      Aims of this open label prospective, randomized trial is to evaluate neointimal hyperplasia~     in patients undergoing bare-metal stent (BMS) implantation alone compared to those receiving~     additional DEB use and to assess if the technique of DEB use may affect the degree of~     neointimal hyperplasia.~      Neointimal hyperplasia will be assessed by Optical coherence tomography (OCT).~   "
191516|NCT01057550|"~     The purpose of this trial was to discover which type of operation for stress urinary~     incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.~   "
191517|NCT01057537|"~     People with established cardiovascular disease need secondary prevention that addresses~     multiple risk factors. Complexity & cost confer particularly difficult barriers to uptake of~     treatment; recovery from a stroke or heart attack typically necessitates multiple drugs for~     cholesterol, blood pressure and platelet function. A low-cost, fixed-dose, once-daily~     combination polypill, the Red Heart Pill, has been formulated by Dr Reddy's Laboratories.~     UMPIRE will evaluate whether provision of this polypill compared with usual medications~     improves adherence and clinical outcomes among high-risk patients in Europe and India. The~     results will be used to develop recommendations for equitable access.~   "
191518|NCT01057524|"~     High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucus~     clearance compared with a control group. These observations led to the development of The~     Vest® which is a non-stretchable jacket connected to an air-pulse generator and worn by the~     patient over the chest wall. The generator rapidly inflates and deflates The Vest®, which~     gently compresses and releases the chest wall between 5 and 20 times per second. This~     generates mini-coughs that are said to dislodge mucus from the bronchial walls and to~     facilitate its movement up the airways. The Vest® has been shown to reduce the viscosity of~     mucus and this should further enhance mucus clearance.~      People with cystic fibrosis (CF), admitted to hospital with an acute infective pulmonary~     exacerbation, should increase the frequency and duration of their airway clearance sessions~     owing to the increase in quantity and viscosity of purulent bronchial secretions.In the~     United Kingdom, and in many other countries, the availability of physiotherapists to assist~     with the recommended number of daily treatments is insufficient to meet patient need. If the~     use of high frequency chest wall oscillation, in addition to 'usual' self airway clearance~     techniques, in the early morning and evening was to facilitate recovery from an exacerbation,~     this would indicate an important place for high frequency chest wall oscillation in the~     management of people with cystic fibrosis.~      Hypothesis:~      The addition of high frequency chest wall oscillation to twice daily supervised physiotherapy~     is as effective as the addition of self treatment in facilitating recovery from an acute~     infective pulmonary exacerbation, as measured by improvement in lung function, specifically~     forced expiratory volume in one second (FEV1).~   "
191519|NCT01057511|"~     Crinone is a micronized progesterone gel which is administrated via vaginal route and~     targeted drug delivery to uterine (first uterine pass effect) with lower serum concentration.~     This study is to investigate the difference of progesterone concentration in serum and~     endometrium after administration with crinone and intramuscular progesterone.~      The study will be conducted as a single centre, randomized, active controlled study.~     Recruitment duration will be 6-8 months long. Day 1 of Crinone administration will be the~     baseline. On Day 7 of Crinone administration endometrial tissue will be taken for P4 test.~     Last visit will be at 3-5 days after withdraw bleeding.~   "
191520|NCT01057498|"~     The purpose of this study is two-fold. First, to determine whether nebulized RNS60 is safe in~     healthy human subjects and in subjects with mild asthma, in a single-dose administration.~     Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate~     asthma over a 4-week period.~   "
191521|NCT01057485|"~     The purpose of the study is to assess combining AF ablation, with AV node ablation and~     pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial~     fibrillation. The study will last 13 months.~   "
191522|NCT01057472|"~     This is a study examining repeatability and feasibility of a new method for measurement of~     lung function in babies. A flexible vest is placed around the torso of the baby, and changes~     in tidal volume and flow is measured. The study will enable a better understanding of the~     usefulness of this equipment in a neonatal intensive care unit. The equipment is made by~     VOLUSENSE Norway AS, and marketed under the name FloRight. The equipment is owned by~     Volusense Norway AS during the study period.~   "
191523|NCT01057459|"~     This research trial studies deoxyribonucleic acid (DNA) analysis in predicting response to~     antibody therapy in patients with follicular lymphoma treated on clinical trials Cancer and~     Leukemia Group B (CALGB)-50402 or CALGB-50701. Studying samples of blood from patients with~     follicular lymphoma in the laboratory may help doctors predict how well patients will respond~     to treatment.~   "
191524|NCT01057446|"~     The aim of the investigators study is to assess the bowel cleansing effects of two different~     agents and to compare their safety of application, ease of usage and effects on serum~     electrolytes.~   "
191525|NCT01057433|"~     This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction~     study.~   "
191526|NCT01057420|"~     Prospective, controlled, randomized crossover volunteer study to investigate the effect of~     hyperoxemia due to inhalation of oxygen (80% inspiratory fraction) via reservoir-face-mask on~     blood coagulation, especially platelet function, as measured by thrombelastography. According~     to results of basic animal and in vitro investigations, hyperoxemia may activate platelets by~     means of reactive oxygen species. This study aims at investigating a possible pro-coagulant~     effect of hyperoxemia in healthy volunteers. Additional studies on possible mechanisms are~     integrated.~        -  Trial with medical device~   "
191527|NCT01057407|"~     This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to~     sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on~     hemodialysis.~   "
191528|NCT01057394|"~     To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.~        1. visually guided ablation (VGA) using the EAS-AC and~        2. radiofrequency ablation~   "
191529|NCT01057381|"~     The hypothesis of this study is that the administration of an intra-operative dose of~     dexmedetomidine will result in adequate analgesia without respiratory depression thereby~     resulting in an early discharge from the post anesthetic care unit following~     adenotonsillectomy.~   "
191530|NCT01057368|"~     This study is focused on the brain mechanisms and peripheral biological correlates of two~     different forms of meditation--mindfulness-based and compassion/loving-kindness. Project 1 is~     focused on the impact of compassion/loving-kindness meditation on emotional reactivity and~     emotion regulation. Project 2 is focused on the neural and behavioral correlates of~     mindfulness meditation and attention and pain regulation. In addition, Project 2 will examine~     the relations between changes in oscillatory rhythms during meditation and attention and pain~     processing. Project 3 will examine the impact of meditation on spontaneous brain activity~     during sleep. This project will also examine the impact of intensive meditation on regional~     changes in slow wave activity during subsequent sleep. Each of these projects will be~     conducted on the same participants so that interrelations among the various measures~     collected in the different projects can be examined. We believe that this study will~     dramatically advance the understanding of the mechanisms by which meditation produces changes~     in behavioral and biological processes.~   "
191552|NCT01057069|"~     This study aims to compare the response of triple-negative breast cancer with deficient~     homologous recombination to intensified alkylating chemotherapy versus standard chemotherapy~     with dose dense AC and/or Docetaxel-Capecitabine.~   "
191532|NCT01057342|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Dimethylxanthenone acetic acid may stop the growth of small cell lung cancer by~     blocking blood flow to the tumor. Giving paclitaxel and carboplatin together with~     dimethylxanthenone acetic acid may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and~     carboplatin together with dimethylxanthenone acetic acid and to see how well they work in~     treating patients with extensive-stage small cell lung cancer.~   "
191533|NCT01057329|"~     The investigators aim to analyse in adolescents with mental illness effectiveness, side~     effects, and serum level concentrations of antipsychotics (olanzapine and aripiprazole),~     antidepressants (Duloxetine, Atomoxetine) by means of Therapeutic Drug Monitoring (TDM) in~     order to optimize dosage - effect relations and minimize unwanted side effects.~   "
191534|NCT01057316|"~     The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on~     the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.~   "
191535|NCT01057303|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at gene expression in tissue samples from young~     patients with acute myeloid leukemia.~   "
191536|NCT01057290|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is looking at biomarkers in cell samples from young patients~     with acute myeloid leukemia.~   "
191537|NCT01057277|"~     The purpose of this study is to determine if RAD001, to a maximum dose of 10 mg/day, can be~     safely administered with cisplatin, and concurrent radiotherapy, for patients with locally~     advanced, inoperable, squamous cell carcinoma of the head and neck.~   "
191538|NCT01057264|"~     The goal of this clinical research study is to find the highest tolerable dose of Abraxane®~     (nab-paclitaxel) when given directly into the liver, in combination with Gemzar®~     (gemcitabine) and Avastin® (bevacizumab) when given by vein.~   "
191539|NCT01057251|"~     The primary object of this study is to evaluate the efficacy and safety of 6 weeks of~     nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.~   "
191540|NCT01057238|"~     This study was a trial of a formal system of family meetings to support family decision~     makers of chronically critically ill patients in the intensive care unit.~   "
191541|NCT01057225|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking~     blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and~     thalidomide may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when~     given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients~     with newly diagnosed active multiple myeloma.~   "
191542|NCT01057212|"~     This is a non-randomized, open-label, single arm phase II trial of the combination of~     bevacizumab and ixabepilone in patients with advanced- or metastatic non-squamous NSCLC~     progressive after first or second-line therapy. The main objective is to evaluate the~     progression-free survival in patients with advanced or metastatic non-squamous NSCLC being~     treated with ixabepilone and bevacizumab.~   "
191543|NCT01057199|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at biomarkers in cell samples from patients with~     acute myeloid leukemia.~   "
191544|NCT01057186|"~     The purpose of the study is to do a follow-up survey of all individuals with hereditary~     hypophosphatemia in Norway, focusing on manifestations in childhood and adolescence. The~     investigators also want to study phenotype-genotype associations, and look for new genes, in~     all forms of hereditary hypo and hyperphosphatemia.~   "
191545|NCT01057173|"~     A randomized clinical trial of transcatheter aortic valve implantation (TAVI) versus~     conventional surgical aortic valve replacement (SAVR) in patients older than 70 years of age~     suffering from severe aortic valve stenosis.~      Study hypothesis: TAVI will reduce post-interventional morbidity and mortality compared to~     SAVR.~   "
191546|NCT01057160|"~     This is a multicentre, open label, prospective, randomized, two-attack study with active~     comparator in patients reporting inadequate response to analgesics and/or triptans to examine~     the efficacy of Rizatriptan 10 mg RPD in this group of patients.~   "
191547|NCT01057147|"~     The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to~     placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye~     disease.~   "
191548|NCT01057121|"~     This phase I/II trial studies the side effects and best dose of lenalidomide and to see how~     well it works in treating patients with acquired immunodeficiency syndrome (AIDS)-related~     Kaposi sarcoma (KS). Lenalidomide may stop the growth of tumor cells by blocking blood flow~     to the tumor.~   "
191549|NCT01057108|"~     The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that~     a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce~     serum levels of phosphorus in patients with chronic kidney disease. We are testing this~     hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a~     small, non-randomized study in patients with chronic kidney disease on hemodialysis.~   "
191550|NCT01057095|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at gene expression in tissue samples from patients~     with acute myeloid leukemia.~   "
191551|NCT01057082|"~     The purpose of this study is to determine whether older adults (ages 65-89) who consume the~     dietary supplement Juven (Abbott Laboratories) versus placebo for 6 months will demonstrate~     increases in fat-free mass, muscle volume,and physical function.~   "
191559|NCT01056978|"~     Even if most patients in palliative care units presented with well-recognized risks factors~     of venous thromboembolism (VTE) (eg: active cancer, bed rest, previous history of venous~     thrombosis), the incidence of VTE in palliative setting is unknown. By consequence, the~     efficacy and safety of antithrombotic prophylaxis in such a population is not established.~     Indeed, patients admitted in palliative care units were not included in trials evaluating the~     potential effect of antithrombotic drugs in regard to their poor prognosis at short term. In~     addition, the main role of prophylaxis is to prevent sudden death from pulmonary emboli and~     is thus a life prolonging therapy which is viewed as counterintuitive to palliative care~     philosophy and inappropriate on grounds of futility. Nevertheless, the current use of Low~     Molecular Weight Heparin in palliative care units seems to increase particularly in patients~     with advanced malignancy. The identification of high hemorrhagic risks in palliative care~     patients could help the decision of antithrombotic prophylaxis initiation. For this, the~     investigators conducted a multicenter prospective longitudinal study.~   "
191560|NCT01056965|"~     The primary objective of the study is to obtain preliminary safety and tolerability data with~     davunetide (NAP, AL-108) in patients with a tauopathy (frontotemporal lobar degeneration~     [FTLD] with predicted tau pathology, corticobasal degeneration syndrome [CBS] or progressive~     supranuclear palsy [PSP]). The secondary objectives of this study are to obtain preliminary~     data on short term changes (at 12 weeks) in a variety of clinical, functional and biomarker~     measurements from baseline, including cerebrospinal fluid (CSF) tau levels, eye movements,~     and brain MRI measurements.~   "
191561|NCT01056952|"~     The aim of the study is to assess, in patients with acute hypoxemic respiratory failure, the~     short term physiologic effects of the high flow oxygen nasal therapy (Optiflow), in term of~     inspiratory muscle effort, gas exchange, comfort and dyspnea~   "
191562|NCT01056939|"~     The purpose of this study is to find out if NAVA-technology is better in detecting patients~     own inspiratory efforts during mechanical ventilation than currently used flow-triggering in~     PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for~     patients or not.~      The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration~     more accurately than currently used methods, and thus will lead to more smooth adaptation to~     mechanical ventilation in pediatric patients. The investigators expect this to decrease the~     time of ventilatory support needed.~   "
191563|NCT01056926|"~     In the present study the investigators will measure the effects of nicotine and non-nicotine~     factors on brain function during cognitive processes that are differentially sensitive to~     these factors. One process—continuous working memory (CWM)—is implemented via a network of~     frontal and parietal brain regions and is highly dopamine dependent. Smoking cessation~     results in significant deficits in CWM which can persist for weeks and are reversed by~     resumption of nicotine administration in the form of smoking or nicotine replacement.~     Additionally, CWM deficits are observed during smoking of denic cigarettes. Brain function~     during CWM is modulated by smoking abstinence and subsequent nicotine administration and~     activity in the dlPFC is implicated in these effects. Collectively, these data suggest that~     CWM is highly sensitive to the nicotine, but not non-nicotine components of smoking. Brain~     function during CWM is altered by smoking abstinence and nicotine, but the effect of smoking,~     in the absence of nicotine, has not been evaluated.~      Another process—cue-reactivity (CR)—results from the repeated pairing of otherwise neutral~     stimuli with nicotine administration. Acute smoking cessation has not been shown to have~     strong effects on CR in the form of cue-provoked craving, nor has nicotine replacement been~     shown to have robust effects on CR. Likewise, the direct effects of smoking abstinence on~     brain CR have been small; though craving has been shown to modulate relations between~     abstinence and CR. Moreover, recent data from our lab suggest larger 'doses' of abstinence (~~     24 hrs) may amplify brain responses to cues. The effect of smoking in the absence of~     nicotine, on CR has not, to our knowledge, been evaluated. Collectively, these data suggest~     that CR in the form of cue-induced craving is not highly sensitive to the effects of~     short-term smoking abstinence or nicotine. Brain CR is modulated by abstinence-induced~     craving and longer-term abstinence, but it is unclear whether abstinence from nicotine or~     non-nicotine components is responsible for these effects.~      In the present study, we propose to evaluate the effects of non-nicotine and nicotine factors~     on CWM and CR using functional magnetic resonance imaging. This method allows for the~     non-invasive assessment of brain function. We will also examine the role of genes in~     moderating and mediating the effects of nicotine and non-nicotine factors on cognitive~     function~   "
191564|NCT01056913|"~     After resection of diseased segments of the large intestine, the continuity of the intestine~     has to be restored. This can be done by suturing or with so called stapling devices. In~     addition since 2 centuries compression rings are used to connect the intestine after~     resection. The NITICAR27 device is a novel compression anastomosis device. The investigators~     want to prove if this novel device can be compared to commonly used stapling devices~     concerning anastomotic leakage, bleeding and stenosis.~   "
191565|NCT01056900|"~     This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron~     transplantation by tracking subjects who had the Chondron implantation to observe~     effectiveness.~   "
191566|NCT01056887|"~     The differential diagnosis of patients with polyuria/ polydipsia is often complex, but~     important for the therapeutic strategy.~      Challenging is in particular the clinical differentiation between patients with a partial~     Diabetes insipidus centralis and patients with primary polydipsia as underlying disease,~     because both groups are associated with similar urinary osmolalities.~      The determination of plasma arginine vasopressin is unusual in this context, since~     measurement of AVP is not reliably.~      C-terminal ProVasopressin (copeptin) is secreted stoichiometrically with AVP from the~     neurohypophysis, but has a longer half life in the circulation, and is thus easier to~     measure.~      Therefore, the investigators will analyze in that study the diagnostic utility of plasma~     copeptin in the differential diagnosis of polyuria and polydipsia.~   "
191567|NCT01056874|"~     This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of~     digoxin, a probe for p-glycoprotein.~   "
191568|NCT01056861|"~     Botulinum toxin injection in the contracting muscles has proven to be a safe and effective~     method of relieving pain and lessening dystonic posturing. The current hypothesis is that~     botulinum toxin works on altering sensory input in the central nervous system in addition to~     its effects on the neuromuscular junction.~      Magnetoencephalography (MEG)of brain has been used in dystonia such as writer's cramp and~     musician's hand dystonia. However, no study has investigated the correlation of central~     signal changes via magnetoencephalography before and after treatment with botulinum in~     torticollis patients. Prior studies using somatosensory potentials indicated the possibility~     of differential activation of precentral cortex in patients with cervical dystonia. Cervical~     dystonia may result from a disorder of both cortical excitability and intracortical~     inhibition. The investigators hypothesis is that botulinum injection modulates central~     inhibition which improves clinical outcome for torticollis.~   "
191569|NCT01056848|"~     To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects~     with euvolemic and hypervolemic hyponatremia~   "
191570|NCT01056835|"~     The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the~     development of chronic allograft nephropathy and changes in allograft function in prevalent~     renal transplant recipients~   "
191572|NCT01056809|"~     For patients with primarily generalized colorectal cancer two treatment strategies are~     compared to establish which strategy gives best overall survival.~      The traditional strategy is to first resect the primary colorectal tumour and then treat the~     metastases with chemotherapy followed if possible by surgery.~      The alternative strategy is to first treat the metastases with chemotherapy followed if~     possible by surgery and only resect the primary colorectal tumour if there is hope for cure~     or if symptoms develop that necessitates treatment.~   "
191573|NCT01056796|"~     The purpose of this study is:~      Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27)~     device for creation of circular, colorectal anastomoses in previously radiated patients.~   "
191574|NCT01056783|"~     This will be a randomised, double blind, placebo controlled, parallel group evaluation of the~     effect of OC000459 given orally for eight weeks on active eosinophilic esophagitis.~   "
191575|NCT01056770|"~     The currently available stock of smallpox vaccine would be insufficient in the face of an~     incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are~     urgently needed because previous manufacturing methods using calf lymph are no longer~     acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea~     has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by~     infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,~     and immunogenicity of CJ-50300.~   "
191576|NCT01056757|"~     The purpose of this study is to learn whether oral Ribavirin is safe and effective in~     treating patients with metastatic breast cancer, that have high levels of eIF4E.~   "
191577|NCT01056744|"~     Background:~      Safety concerns regarding use of drug eluting stent systems (DES) are related mostly to late~     stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Specific~     information about time course and amount of endothelial strut coverage of different DES is~     required, in order to further refine the concept of antiplatelet therapy after DES~     implantation. Optical coherence tomography (OCT) is emerging as a new gold standard for~     endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal~     proliferation. Very limited OCT data about endothelial coverage of DES are currently~     available. Aim of this study is a comparative evaluation of XIENCE V® everolimus eluting~     stent (Abbot Vascular) and of the bare metal stent (BMS) Coroflex® Blue postdilated with the~     drug-eluting balloon (DEB) SeQuent® Please (paclitaxel-eluting balloon, B. Braun Melsungen~     AG) in terms of endothelial coverage and neointimal proliferation using OCT.~      Study Design:~      A number of 80 patients scheduled for elective percutaneous coronary intervention (PCI) with~     a native coronary stenosis suitable for DES implantation and OCT imaging are openly~     randomized 1:1 to either XIENCE V® or Coroflex® Blue/Sequent® Please. The study is~     prospectively conducted at a university high-volume PCI center with OCT expertise (Jena,~     Germany). Angiographic follow-up and OCT imaging with motorized pull-back at 1 mm/s are~     planned in all patients 6 months after implantation of the study stents. OCT endpoints are:~     (1) endothelial coverage, expressed as % of struts without coverage and % of stent length~     containing non-covered struts, and respectively (2) neointimal proliferation, given as %~     neointimal volumetric proliferation within the whole stent and also as focal peak %~     neointimal area proliferation. The study is not powered for clinical endpoints, which are:~     subacute or late stent thrombosis and need for revascularization of the stent segment. Given~     the high number of measurements (15 cross-section images / 1 mm stent length), OCT endpoints~     are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up~     to 20%.~   "
191578|NCT01056731|"~     This is an open-label, not controlled, sequential, dose escalation study of 16 weeks'~     duration. The study is composed of two periods: a 0-2 week optional wash-out period depending~     on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment~     period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with~     Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25~     if control of BP is not achieved (< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All~     patients who have reached their BP target will be considered as having met the primary~     endpoint and this visit will be considered as the final visit.~   "
191579|NCT01056718|"~     The goal of this pilot study is to effectively treat hypertension in subjects with either~     known or newly diagnosed hypertension and concurrent evidence of diastolic dysfunction. Due~     to the unique properties of nebivolol, it is hypothesized that there will be improvements in~     left ventricular (LV) systolic and diastolic function manifesting as increase exercise~     capacity in this patient population with primarily LV diastolic dysfunction. The present~     study was performed to determine the effects of nebivolol on blood pressure, exercise~     tolerance and parameters of left ventricular systolic and diastolic function in a group of~     hypertensive patients with echocardiographic evidence diastolic dysfunction.~   "
191580|NCT01056705|"~     Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of~     phase Ⅱ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis~     Vaccine made from Sabin Strains(Sabin IPV).~   "
191581|NCT01056692|"~     OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients~     with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of~     OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic~     response in the lungs, namely cat hair, pollen or house dust mite and methacholine.~   "
191582|NCT01056679|"~     The purpose of this study is to determine within the scope of the trial what the maximum~     tolerated dose (MTD) of lenalidomide in combination with AVD should be.~   "
191583|NCT01056666|"~     The objective of this investigation is to asses with validated scales, the impact on the~     quality of life of men suffering of moderate to severe incontinence of the use of Conveen~     Optima urisheath in comparison with their usual absorbent protection.~   "
191584|NCT01056653|"~     The purpose of this study is to test an educational intervention for first-time fathers of~     late preterm (34 to 36 weeks gestation) infants.~   "
191595|NCT01056510|"~     This randomized, open-label, parallel group study will assess the effect on response rate and~     the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic~     lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A)~     MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as~     first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera~     plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive~     up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is~     6-12 months, and target sample size is 600-700 individuals.~   "
191596|NCT01056497|"~     Chronically elevated free fatty acids impair insulin sensitivity and insulin secretion (ie~     lipotoxicity) by a combination of oxidative stress, endoplasmic reticulum (ER) stress and~     inflammation. This study will test whether alpha-lipoic acid, which has potent antioxidant~     and anti-inflammatory properties, prevents or ameliorates lipotoxicity.~   "
191585|NCT01056640|"~     Background: Older adults with multiple chronic illnesses are at risk for worsening functional~     and medical status with ensuing hospitalization. One goal of medical care is to prevent this~     decline. One method that may help slow this functional and medical decline is home~     telemonitoring.~      Specific aim: To determine the effectiveness of home telemonitoring compared to usual care in~     reducing combined outcomes of hospitalization and emergency room visits in an at risk~     population over 60 years of age.~      Materials and Methods: This will be a randomized trial of 200 patients into one of two~     interventions. Home telemonitoring involves the use of a computer device at home which~     records biometric and symptom data from patients. This information is monitored by mid level~     providers associated with the primary care medical practice. Usual care involves patients who~     make appointments with their providers as problems arise and utilize ongoing support like a~     24 hours nurse line. The study participants are adults over 60 years of age within the~     highest 10% on elderly risk assessment (ERA) scores. Patients will have initial evaluations~     of gait, quality of life (SF12), Kokmen test of mental status, and PHQ 9. Patients will be~     followed for 1 year for primary outcomes of hospitalizations and emergency room visits.~     Secondary analysis will include quality of life, compliance with the device and attitudes~     about telemonitoring. Sample size is based upon an 80% power to detect a 36% difference~     between the groups. The primary analysis will involve Cox proportional time to event analysis~     comparing both interventions for telemonitoring or usual care. Secondary analysis will use~     T-test comparisons for continuous variables (quality of life, attitudes) and chi square for~     proportional analysis.~   "
191586|NCT01056627|"~     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,~     crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with~     Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fed conditions.~   "
191587|NCT01056614|"~     This phase II trial is studying the side effects and how well giving fludarabine phosphate,~     busulfan, anti-thymocyte globulin followed by donor peripheral blood stem cell transplant,~     tacrolimus, and methotrexate works in treating patients with myeloid malignancies. Giving~     chemotherapy, such as fludarabine phosphate and busulfan, before a donor peripheral blood~     stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor~     can make an immune response against the body's normal cells. Giving anti-thymocyte globulin~     before transplant and tacrolimus and methotrexate after transplant may stop this from~     happening.~   "
191588|NCT01056601|"~     Cancer results from multiple mutations which cause cells to grow uncontrolled. It therefore~     may be necessary to inhibit several oncogenic targets to affect cancer cell growth. Studies~     have shown that panobinostat (LH589) causes a wide range of effect on endothelial cells that~     lead to inhibition of tumor angiogenesis (a fundamental step in the transition of tumors from~     a dormant state to a malignant one). Bortezomib triggers cell death in pancreatic cancer~     cells but the mechanism is not well defined but has been determined to be cytostatic.~     Combining these two drugs may work together in the treatment of pancreatic cancer.~   "
191589|NCT01056588|"~     The primary objective of this research is to evaluate the effectiveness of this type of~     smoking cessation program by comparing a treatment group with a control group.~      A secondary objective of this research is to explore relations between impulsive behavior and~     smoking-cessation success among treatment-seeking teens participating in a quit-smoking~     program.~      Hypothesis 1. A greater proportion of the participants in the treatment condition will be~     verified as abstinent from smoking during the course of treatment than participants of the~     control condition.~      Hypothesis 2. It is hypothesized that teens who do not successfully stop smoking (or who drop~     out of the treatment program) will be more impulsive (from measures taken just prior to~     treatment) than those who do successfully stop or significantly reduce rate of smoking.~   "
191590|NCT01056575|"~     This will be an open label, sequential study of midazolam (dose 5 mg orally) followed by~     midazolam (5 mg orally) given after dosing with OC000459 100 mg twice daily for 6.5 days.~     Twenty subjects will be included to ensure at least 16 subjects with analysable PK data. PK~     sampling for midazolam and 4-hydroxymidazolam plasma concentrations will continue for up to~     and including 24 hours after dosing with midazolam on both occasions.~   "
191591|NCT01056562|"~     The male sex-hormone called testosterone is known to play a key role in the growth of~     prostate cancer. The usual treatment for the disease involves suppression of hormones~     (testosterone) by anti-hormonal treatment for an unknown period of time until the cancer~     progresses. This anti-hormonal treatment usually consists of injections every three months~     with an LHRH(Leutinizing Hormone-Releasing Hormone) agonist and a short course of~     anti-androgen pills, which together help to lower the production of testosterone. Long-term~     hormonal treatment has potentially serious side effects and is expensive.~      In this study, hormonal treatments will be with held from those patients eligible and willing~     to participate. The aim of this study is to see if we can decrease the amount of hormone~     injections that patients require. This might lead to a decreased side effects(such as~     decrease in bone health, cardiovascular problems and metabolic syndrome which occurs when~     several health conditions happen at the same time and can lead to an increased risk of heart~     disease, stroke and diabetes) as well as to decrease the cost of hormonal therapy to treat~     prostate cancer.~   "
191592|NCT01056549|"~     Exenatide acutely inhibits intestinal lipoprotein particle production. We are unable to~     speculate whether exenatide affects hepatic lipoprotein production in humans since there is~     currently no evidence from animal models or in vitro studies that have demonstrated an effect~   "
191593|NCT01056536|"~     The objective of this study is to assess the impact of a structured intervention and/or free~     distribution of condoms during the pre-travel consultation on sexual risk behavior of young~     persons traveling alone.~   "
191594|NCT01056523|"~     The purpose of the study is to determine the maximum tolerated dose of ribavirin, when given~     in combination with low-dose ara-C and to determine if it is safe and well-tolerated in~     patients with acute myeloid leukemia.~   "
191597|NCT01056484|"~     The purpose of this 52-week clinical trial is to see if the meditation-based intervention,~     adjunctive to standard of care therapy, can reduce relapse and improve psychological health~     among adults recovering from alcohol dependence.~   "
191599|NCT01056458|"~     This study is expected to show auricular acupressure therapy help to improve the anxiety~     symptoms of perimenopausal and early postmenopausal women, looking forward to developing a~     convenient, safe and effective way to reduce the use of sedative hypnotics and their~     dependencies, thereby improving their quality of life.~   "
191600|NCT01056445|"~     Hemodynamic instability was controlled in 27 patient during carotid stenting and it was~     showed that hemodynamic instability can be predicted by Valsalva maneuver before stenting and~     hemodynamic instability have no prognostic effect on result of carotid stenting.~   "
191601|NCT01056432|"~     The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical~     data which will help to optimize the BUSS examination procedure and its diagnostic algorithms~     for assessment of bone conditions.~   "
191602|NCT01056419|"~     The relationship between the method of the treatment of hyperthyroidism due to Graves'~     disease and the course of Graves' ophthalmopathy is debated. The investigators aimed to~     compare the results of total thyroidectomy done in 6 months following the appearance of the~     symptoms of ophthalmopathy and the antithyroid drug therapy in patients with moderate to~     severe Graves' ophthalmopathy.~      The inclusion criteria: 1)Hyperthyroidism and moderate to severe Graves' ophthalmopathy~     within 6 months, 2)Thyroid volumes greater than or equal to 15 mL in thyroid ultrasonography,~     3)Patients taking no treatment except local medications for Graves' ophthalmopathy,~     4)Clinical activity score of 3/7 or more, proptosis greater than or equal to 21 mm in one eye~     or 2 mm difference between two eyes, presence of diplopia, the opening of the eye lid greater~     than or equal to 9 mm.~      All patients will be treated with antithyroid drug until TSH levels of the patients are~     between 0.4-1. During this period all the patients will take pulse methyl prednisolone~     treatment of a total dose of 4.5 gr. After pulse steroid treatment the patients will be~     randomised to two groups: one group will be sent to surgery for total thyroidectomy, and~     their TSH levels will be kept between 0.4-1 with levothyroxine treatment; the other group~     will be followed under antithyroid drug treatment and their TSH levels will be kept between~     0.4-1 also.~      The smoking habits will be asked. Serum TSH, fT4 levels, Hertelmeter and eye lid opening~     measurements, clinical activity scores, diplopia will be evaluated monthly; TSH receptor~     antibody, anti-thyroid peroxidase and anti-thyroglobulin levels will be measured in 3 months~     intervals for a period of 12 months.~   "
191603|NCT01056406|"~     The purpose of this study is to determine if twice monthly interaction with a registered~     dietitian from 6-16 weeks gestation through 6 months postpartum will help women who are~     overweight or obese gain weight during pregnancy closer to the Institute of Medicine~     (IOM)guidelines and lose weight more effectively within the 6 month postpartum period than~     those who do not receive twice monthly interaction with a registered dietitian during this~     period.~      Overweight/obesity can lead to a number of adverse pregnancy, delivery and birth outcomes,~     including increased risk of hypertension, eclampsia, and diabetes during pregnancy,~     miscarriage, premature delivery, birth injuries, neural tube defects, and prenatal death.~     More than half of women of childbearing age are overweight or are obese. Women of color and~     low-income women are affected disproportionately.~      Unfortunately, women know little, if anything, about the impact of overweight and obesity on~     pregnancy and health care providers are unsure how to effectively address the problem with~     their patients.~      A limited number of programs have tested ways to effectively address weight gain management~     during pregnancy. None have been successful in addressing weight gain in women who are obese~     or overweight at the start of pregnancy. The 2-year Revere Health Center Pregnancy Weight~     Management Study will test the feasibility and efficacy of providing pregnant women who are~     overweight or obese with regular access to a registered dietitian during and after pregnancy~     to help achieve total weight gain closer to recommended guidelines and to ensure the best~     outcomes for the mother and her newborn.~   "
191604|NCT01056393|"~     This protocol serves to extend the successful treatment for HIV positive patients beyond the~     endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled A~     Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab~     Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1~     (Amended to 24 Week Study)), for 24 weeks. Ibalizumab may be administered beyond 24 weeks~     under this protocol as supply permits and patients continue to demonstrate virologic~     response.~   "
191605|NCT01056380|"~     This is a randomized clinical trial designed to evaluate oral nitazoxanide compared to a~     placebo in the treatment of acute uncomplicated influenza in adults. We hypothesize that~     treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed~     influenza infection. Secondarily, we hypothesize that treatment with nitazoxanide will reduce~     the complications of influenza, severity of symptoms, time lost from work, time to return to~     normal daily activities, and viral shedding.~   "
191606|NCT01056367|"~     The risk of cardiovascular disease (CVD) in patients with type-II-diabetes mellitus~     (type-II-DM)is more than doubled and CVD accounts for 70% of deaths in this group of~     patients.~      Hypertension is a major risk factor for CVD in patients with type-II-DM and a major~     contributor cardiovascular mortality. Uncontrolled- (UH) and resistant hypertension (RH)are~     more common in patients with type-II-DM, why further bloodpressure (BP) control is needed.~      The prevalence of UH and RH has not been examined in a consecutive Danish outpatient~     population with type-II-DM.~      The purpose of this study is to examine the prevalence of resistant hypertension in patients~     with type-II-diabetes and to examine the characteristics of patients with resistant~     hypertension as compared to patients with controlled hypertension with regards to arterial~     stiffness.~   "
191607|NCT01056354|"~     Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus,~     this observational study was initiated to describe participants seeking medical care in~     geographically diverse locations with 2009 H1N1 infection and their clinical course over a~     14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus~     was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was~     expanded to include other influenza A subtypes and influenza B viruses. This version of the~     protocol further broadens the scope of this observational study. With the recognition that~     novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory~     Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health~     importance, the objectives of this protocol have been expanded~   "
191608|NCT01056341|"~     There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a~     good benefit/risk profile. Based on the recent findings of encouraging results obtained with~     propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is~     expected to be of significant benefit in the management of the condition. The present study~     has been designed to confirm efficacy of propranolol in severe IH by demonstrating~     superiority over placebo and to document the safety profile of propranolol in this~     indication.~   "
191609|NCT01056328|"~     The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation~     System for the treatment of symptomatic paroxysmal atrial fibrillation.~   "
191610|NCT01056315|"~     This trial is assessing the analgesic efficacy and safety of a new central analgesic in~     subjects with pain due to diabetic peripheral neuropathy (DPN).~   "
191611|NCT01056302|"~     This study proposes to develop a computer-based software tool that will allow surgeons to~     plan and simulate surgery for patients with jaw trauma.~   "
191612|NCT01056289|"~     Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated~     for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation~     (DVS SR)~   "
191613|NCT01056276|"~     In this study, investigators will evaluate the activity of bendamustine, bortezomib and~     dexamethasone (BBD). This regimen combines 3 agents with high activity in multiple myeloma,~     with different mechanisms of action and non-overlapping toxicities.~   "
191614|NCT01056263|"~     The primary objective of this observational study is to retrospectively collect current~     survival data for patients originally included in axitinib A4061012 [NCT00076011] study to~     estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with~     axitinib.~   "
191615|NCT01056250|"~     Single Incision Laparoscopic Surgery (SILS) can be performed for different standard~     operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy~     sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to~     identify and preserve relevant structures. The investigators want to evaluate feasibility of~     performing cholangiography during SILS cholecystectomy.~   "
191616|NCT01056237|"~     An multi-site, randomized, prospective study to compare the efficacy and safety of~     multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza~     therapy.~   "
191617|NCT01056224|"~     Skull pin insertion during craniotomies is a brief, intensely stimulating, painful stimuli~     occurring during the conduct of a neurosurgical or spine anesthetic. Remifentanil is an ultra~     short acting opioid that has been successfully used to blunt hemodynamic responses in a wide~     variety of clinical scenarios. It is our intention to ascertain the optimal dose for blunting~     the hemodynamic response to skull pin insertion using remifentanil.~   "
191618|NCT01056211|"~     Scars are a frequent reason of consultation in a dermatological clinic. Their cosmetic aspect~     can play a key role in patient satisfaction and self-image.~      Non ablative fractional infra-red laser treatment is a new concept in the laser field using~     arrays of microscopic thermal damage patterns to stimulate a wound healing response. There~     are different reports on the positive effect of these type of laser treatment in the~     treatment of acne scarring, striae, rythides, hypopigmented and hypertrophic scars.~      The low morbidity of the treatment and the lack of satisfying treatment regimes for different~     types of scars makes it attractive to investigate the efficacy and safety of 4 treatment with~     the 1540nm non ablative fractional laser in the treatment of scars.~      Objectives:~        -  To evaluate the efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional~          laser handpiece ( Palomar Medical Technologies ) 1 and 3 month after the last laser~          treatment for 3 different scar patient groups :~             1. Patients with hypopigmented scars~             2. Patients with hypertrophic scars~             3. Patients with scars due to grafts and reconstructions in the head and neck region.~        -  To evaluate the treatment related pain. on a categorical scale from 0-10~        -  To evaluate the adverse effect of 1540nm fractional laser versus untreated control in~          the 3 patient groups.~      The study design is a prospective single blinded randomised within-patient controlled study~     The study involves 6 visits.~   "
191619|NCT01056198|"~     This study tests two different approaches to the removal of dead tissue from the surface of a~     wound.~   "
191620|NCT01056185|"~     Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus,~     this observational study was initiated to estimate rates of morbidity and mortality and to~     examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as~     surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza~     A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes~     and influenza B viruses. The current version of the protocol (released in August 2013)~     further broadens the scope of this observational study. With the recognition that novel~     respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory~     Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health~     importance, the objectives of this protocol have been expanded.~   "
191621|NCT01056172|"~     This study aim to evaluate the non-inferiority of sustained virologic response in~     peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment~     duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.~   "
191622|NCT01056159|"~     The study will measure the improvement in lung function in subjects with asthma after~     inhaling from two inhalers, Albuterol in a dry powder inhaler and albuterol in an HFA~     (hydrofluoroalkane), metered dose inhaler.~   "
191623|NCT01056146|"~     The purpose of this study is to test an on-line intervention for families of young children~     who have experienced moderate or severe traumatic brain injury (TBI). Previous interventions~     were not designed to address the needs of young children with TBI, and feedback revealed a~     desire for more examples and materials appropriate for families of younger children. This~     project builds upon the investigators previous research by modifying the online intervention~     content to address the needs of young children with TBI. The goal of this project is to~     develop an intervention that will encourage positive parenting behaviors, improve child~     behaviors, and reduce parent distress and burden following TBI. The investigators hypothesize~     that the intervention group will exhibit more effective parenting skills as well as better~     child functioning and lower levels of parental distress at follow-up than will the active~     comparison group.~   "
191626|NCT01056107|"~     This trial will study the effects of an investigational (not FDA approved) medication,~     ROSE-010, on the movement of food through the stomach, small intestine and colon in females~     with constipation predominant irritable bowel syndrome (C-IBS).~      The study hypothesis is that ROSE-010 will delay gastric emptying of solids and enhances~     gastric accommodation without retarding colonic transit in female patients with C-IBS.~   "
191627|NCT01056094|"~     Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased~     interest in evaluating the effect of lutein for optimizing immune functions. A large number~     of epidemiological studies support the notion that a high intake of lutein is associated with~     a reduced risk of coronary heart disease and certain types of cancer. The biological~     mechanisms for the protective effects of this carotenoid, including powerful modulation of~     functions and antioxidant properties, are only partially known. Although several nutrients~     and phytochemicals have been shown to modulate immune functions in humans, few studies have~     investigated the role of lutein consumption. No information is available as to whether lutein~     supplementation could be protective against oxidative stress. Therefore, the objective of the~     present study was to examine the effect of consuming different doses of lutein on oxidative~     stress in healthy subjects.~   "
191628|NCT01056081|"~     Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training~     (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary~     disease. In this study the investigators investigate whether IMT associated with exercise~     training would be better than exercise training alone, with regard to exercise capacity,~     inspiratory muscle strength and dyspnea.~   "
191629|NCT01056055|"~     This prospective, randomized study was conducted to compare the clinical outcomes of the~     modified Brostrom procedure using a suture anchor and bone tunnel for chronic lateral ankle~     instability.~   "
191630|NCT01056042|"~     Patients with endometriosis-associated pain have conservative surgery performed to remove all~     visible lesions. Then, patients are randomized into two groups. In the first group patients~     have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In~     the second group patients have oral contraceptive combined pills everyday for 6 months.~     Patients are followed up on recurrence of pain for 1 year after medication.~   "
191631|NCT01056029|"~     This is an open-label, single-arm, dose-escalation Phase I study to determine the maximum~     tolerated dose (MTD) of G-202 (mipsagargin) when administered once daily for 3 consecutive~     days of a 28-day cycle in patients with advanced solid tumors. G-202 will be administered by~     intravenous infusion over 1 hour on Days 1, 2 and 3 of each 28-day cycle.~   "
191632|NCT01056016|"~     The American Academy of Pediatrics (AAP) has established a set of consensus guidelines for~     pediatricians to follow. These guidelines can be challenging to implement in typical~     community-based practices. Cincinnati Children's Hospital Medical Center (CCHMC) has~     developed a program called the ADHD Collaborative to promote the adoption of these guidelines~     among community pediatricians. The program focuses on modifying the office system using~     academic detailing and quality improvement (QI) methodology to accommodate prescribed~     practice changes. The ADHD Collaborative has been very successful at recruiting practices in~     the Greater Cincinnati area, changing practice behaviors, and sustaining these practice~     behaviors over time at minimal cost to the project and to the office practice. Now that~     sustainability and effectiveness have been established, the next step is to modify the ADHD~     Collaborative model to make it amenable to widespread dissemination. The primary goal of the~     proposed study is to modify the ADHD Collaborative intervention to make it transportable and~     then evaluate this version in terms of effectiveness, consumer satisfaction, and costs.. A~     transportable intervention is described that utilizes telehealth videoconferencing, a web~     portal, and long-distance data collection. Initially, three pediatric practices will be~     recruited to test and refine the distal intervention delivery methodology. Then, eight new~     pediatric practices will be randomly assigned to receive the distal intervention or to a~     control group (treatment as usual). Information about pediatric practice behavior will be~     collected at baseline, 6-months, and 1-year post-baseline. The study design will allow for a~     preliminary assessment of the feasibility and effectiveness of the distal intervention in~     terms of rates of evidence-based practice behaviors to patients, change in pediatrician~     attitudes, consumer satisfaction, and costs.~   "
191633|NCT01056003|"~     As known from several observational and retrospective endoscopic studies the prevalence of~     gastric inlet patches (GIPs) of the cervical esophagus is estimated between 1-10%. In most~     cases GIPs are found within endoscopy as an incident finding, since in most cases they are~     harmless and do not cause any symptoms. None the less several data exist where an association~     between GIPs and globus sensations is discussed. Case reports even refer to bleeding~     complications and moreover to malignant transformations of GIPs.~      As a result of the assumed association of GIPs and globus sensations we performed a pilot~     trial. Here we included 10 patients with globus and GIPs and were able to demonstrate a~     significant symptom relief after ablation of the GIP (Meining et al, Endoscopy 2006). To~     exclude a potential placebo-effect we concluded a multicenter and sham controlled trial where~     we imposingly were able to prove the symptom relief after ablation of the GIPs (Bajbouj et~     al, Gastroenterology 2009).~      All patients, who are scheduled for esophagogastroduodenoscopy (EGD) in any of the above~     mentioned endoscopical departments are routinely standardized asked whether they have any~     hints suggestive for globus sensations (modified globus-questionnaire from Deary et al., J~     Psychosom Res 1995). Concurrently it is noted, whether the patients have endoscopical~     detected GIP. All GIPs are biopsied and examined in one institute. Together with anamnestic~     data (age, gender) a talley sheet gives a survey of all relevant information to prove or~     disprove following hypotheses.~      Study hypotheses:~        1. The presence of GIPs is associated with globus sensations. In other words: Do patients~          with globus sensations significantly more often have GIPs?~        2. GIPs are not congenital, they arise in the course of the time and become symptomatic. In~          other words: Do GIPs significantly occur in more elderly people?~        3. The more increased the GIPs diameter is the more likely globus sensations are present?~          In other words: Do huge GIPs cause significantly more often symptoms than small ones?~        4. The more mucus-producing mucosa is histologically proven the more likely globus~          sensations are present? In other words: Do we find more cardiac mucosa in patients with~          symptoms than fundus mucosa?~   "
191634|NCT01055990|"~     The 2009 flu pandemic is a global outbreak of a new strain of influenza A virus subtype H1N1,~     commonly known as swine flu, that was first identified in April 2009. Large-scale~     immunization is an essential approach of controlling the pandemic.Vaccines are now becoming~     available for protection against pandemic influenza A(H1N1) 2009 infection in some~     countries.In response to the pandemic, novel vaccines against the virus strain~     A/California/07/2009(H1N1) have been developed and recently were approved for vaccination~     among specific populations in China. However, the safety and effectiveness of the vaccines is~     of prime concern to the authorities and the public.This report details the findings of a~     observational clinical trial of the safety and immunogenicity of a influenza A (H1N1)2009~     monovalent vaccine.~      The virus of Swine Flu H1N1 that outbroke in 2009 is sensitive to neuraminidase inhibitors~     (Oseltamivir, zanamivir and peramivir) but have drug resistant to adamantanamine derivatives~     (amantadine and Flumadine), therefore neuraminidase inhibitors are recommended for antiviral~     therapy against Swine Flu H1N1, effect of which is evidence by the data that such drugs do~     modify the symptoms and decrease the death rate of H1N1 in America and Mexico. However,~     clinically, the investigators have encountered that this virus can infect resistant strains~     of Oseltamivir, which urges for a more effective treatment plan.~      In view of above situations, seeking for an effective measures against H1N1 flu should be a~     top priority and will benefit human life and economy globally. This Topic will take the~     classic strategy of passive immunity to perform basic and clinical researches on applying~     blood fix to treat critical H1N1 patients and collect blood of healthy persons who are~     inoculated with specific H1N1 vaccines to cure critical H1N1 patients.~   "
191654|NCT01055730|"~     The purpose of this study is to determine if pulmonary rehabilitation has any effect on~     breathlessness, quality of life, physical function and depression in persons with~     interstitial lung disease.~   "
191635|NCT01055977|"~     Statins are the first choice treatment of dyslipidemia, a major contributor to cardiovascular~     diseases. Statins also have enough evidence to demonstrate decrease of morbidity and~     mortality from cardiovascular diseases. Even though statin therapy is effective treatment of~     dyslipidaemia not all patients reach the goal levels.~      The aim of the study is to estimate proportion of patients who achieved the therapeutic goal~     (LDL-C. total cholesterol, HDL-C and triglycerides levels) after at least one year of a~     statin therapy.~   "
191636|NCT01055964|"~     The aim of this study is to identify the pharmacokinetic differences between two oral forms~     of Tacrolimus and consequent nephrotoxicity.~   "
191637|NCT01055951|"~     The purpose of this study is to assess the safety and usability of the Solo™ insulin~     MicroPump in subjects with type 1 diabetes who are pump users.~   "
191638|NCT01055938|"~     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,~     crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with~     Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.~   "
191639|NCT01055925|"~     The almost single disadvantage of conventional polyurethane film dressings, an uncontrolled~     leakage, is probably as often described as its numerous advantages for split-thickness skin~     graft (STSG) donor sites. This shortcoming can be overcome by perforating the polyurethane~     dressing (MPD), which permits a controlled leakage into a secondary absorbent dressing. The~     study was conducted to compare the MPD-system and Aquacel® (ConvaTec), a hydrofiber wound~     dressing, which also seems to fulfill all criteria of an ideal donor site dressing.~   "
191640|NCT01055912|"~     The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients~     with congestive heart failure.~   "
191641|NCT01055899|"~     This study will test the safety and tolerability (how the body reacts to the drug) of REGN88~     and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid~     Arthritis.~   "
191642|NCT01055886|"~     The investigators propose to evaluate the relationship between PTSD, mood, craving and~     withdrawal symptoms and factors associated with relapse in the context of a randomized~     clinical smoking cessation trial. The use of supplemental nicotine administration (SNA)~     during a pre-treatment phase before a targeted quit date is an innovative development in~     smoking cessation, and may be helpful in treating smokers with PTSD. The use of SNA during ad~     lib smoking for smokers with PTSD is predicted to reduce both the physiological and emotional~     dependence on inhaled nicotine, thereby increasing the odds of successful smoking cessation.~      Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions~     (active patch versus placebo patch) for 2 weeks before a target quit-smoking date. All~     participants will receive brief cognitive-behavioral therapy (CBT) and will begin standard~     nicotine replacement therapy on their quit day. PTSD symptoms, mood, smoking craving and~     withdrawal symptoms will be evaluated using electronic diary assessment for one week prior to~     the pre-cessation period, during the 2-week pre-cessation period, and 6 weeks post quit date.~     The study is designed to address the following aims:~      Specific Aim 1: To examine the effects of SNA on PTSD symptoms, mood, craving and withdrawal~     through electronic diary assessment.~      Hypothesis 1.1. SNA will decrease craving for cigarettes during the 2 week pretreatment~     period as compared to the placebo patch condition.~      Hypothesis 1.2. SNA will decrease the perceived improvement in mood and PTSD symptoms~     associated with smoking behavior.~      Hypothesis 1.3. SNA during the pre-cessation period will result in a reduction of withdrawal~     symptoms following the quit-date.~      Specific Aim 2: To evaluate the effect of SNA on quit rates among smokers with PTSD.~      Hypothesis 2. SNA during the pre-cessation period will result in improved quit rates Specific~     Aim 3: To investigate potential predictors of relapse including PTSD symptom severity, mood,~     anxiety sensitivity, distress tolerance, and self-efficacy.~      Hypothesis 3.1 - 3.5 Increased PTSD symptom severity, increased baseline negative affect,~     increased anxiety sensitivity, decreased distress tolerance, and lower self-efficacy each~     will independently be associated with shorter abstinence from smoking.~   "
191643|NCT01055873|"~     ANRS-EP38-IMMIP is a non interventional study. A single blood sample (30 mL) was drawn during~     a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood.~     Cells and plasma were stored and kept frozen for additional biological evaluations.~      Patients are included in the French perinatal cohort (ANRS CO-10), or have been followed~     since before 1996 in the same clinical sites as patients who belong to ANRS CO-10. In the~     ANRS CO-10 cohort, all patients are prospectively followed from birth.~   "
191644|NCT01055860|"~     Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce~     in regard to its long-term outcomes. This advanced procedure is offered at MMH through the~     Urogynecology division. The Investigators setup to review the one year outcome of patients~     who underwent this procedure using a polypropylene mesh. These outcomes will include~     anatomical and quality of life measures.~   "
191645|NCT01055847|"~     This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two~     dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.~   "
191646|NCT01055834|"~     The purpose of this study is to investigate and evaluate the bioequivalence and food effect~     of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.~   "
191647|NCT01055821|"~     The primary objective of this protocol is to study the effect of the standard of care in~     hepatitis C (pegylated interferon and ribavirin) associated with therapeutic vaccine TG4040~     on the viral load of treatment-naïve patients with chronic genotype 1 hepatitis C infection.~   "
191648|NCT01055808|"~     This study is designed to address the gap in the literature related to changing treatment~     regimen or formulation between different types of insulin, and how this change impacts~     quality of life, adherence, individual patient treatment satisfaction and glycemic control.~   "
191649|NCT01055795|"~     The main purpose of this study is to test the safety of three study drugs, bevacizumab~     (Avastin™), Everolimus (Afinitor™) and LBH589 (Panobinostat) when they are given together. It~     is hoped this study drug combination might lead to a greater decrease the in size of the~     cancer and/or slow down how fast the cancer is growing compared to when these drugs are given~     alone.~      Subjects will be enrolled at Duke University Medical Center (DUMC).~   "
191650|NCT01055782|"~     The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with~     or without endoguide.~      The study will investigate whether the endoguide improves success rate and the patient's~     perception of pain.~   "
191651|NCT01055769|"~     The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral~     Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used~     to support Linezolid OS NDA in China.~   "
191652|NCT01055756|"~     The primary objective of this study is to evaluate the clinical efficacy of the drug~     Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin~     D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic~     rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and~     laboratory (nasal flow) down through time.~   "
191653|NCT01055743|"~     This study will assess the clinical efficacy and safety of fluorouracil implants regional~     chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.~   "
191656|NCT01055704|"~     This is a single-center, randomized, double blind, placebo-controlled study evaluating the~     effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on~     gastrointestinal motility and colonic transit of solids in healthy human subjects.~      The hypotheses are:~        1. Methylnaltrexone administered subcutaneously enhances gastrointestinal motility with~          acceleration of overall colonic transit, and ascending colon emptying of solids in~          healthy humans.~        2. Methylnaltrexone significantly accelerates colonic transit that is delayed by codeine~   "
191657|NCT01055691|"~     The primary objective of the study is to establish if the same amount of drug is absorbed~     into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the~     individual dapagliflozin tablet and individual metformin tablet.~   "
191658|NCT01055678|"~     The purpose of this pilot study is to determine the prevalence of markers of chronic and~     cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer~     tumor microenvironment. The study is based around four cornerstone features of the pathologic~     microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1~     and VEGF, which we term the HRHV axis. Fifty breast cancer patients with planned surgical~     excision will be administered the hypoxia marker drug, EF5, 24-36 hr prior to surgical~     excision. EF5 is a non-therapeutic drug and provides no direct benefit to those patients~     enrolled in this pilot study. Tissues obtained intra-operatively will be snap frozen and~     subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of~     immunohistochemical and urine markers that depict the HRHV axis will be examined. The~     association of the markers with the presence of hypoxia, as determined by EF5 positivity,~     will be determined. Data from this pilot study will be used to establish the prevalence of~     markers of the HRHV axis in breast cancer. This information will be crucial for future human~     trials in which the HRHV axis is therapeutically targeted.~   "
191659|NCT01055665|"~     The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment~     for depression, on self-efficacy (feeling empowered to accomplish a given task) and~     depression in persons with chronic pain and depression. Past research has shown that persons~     with chronic pain show improvement in self-efficacy and depression scores when they are using~     CBT. The Pain rehabilitation Center (PRC) at Mayo Clinic is adding CBT focused groups to~     better understand the role of CBT on self-efficacy and depression in persons with chronic~     pain and depression.~   "
191660|NCT01055652|"~     The purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when~     administered alone or in combination with voglibose in Japanese patients with type 2 diabetes~     by assessment of AUC and Cmax of dapagliflozin~   "
191661|NCT01055639|"~     The purpose of the study is to test a brief, individual psychosocial in-person or telehealth~     intervention to reduce interference of pain with daily life, emotional distress, and pain~     intensity, and improve quality of life and physical activity levels in individuals with~     chronic pain.~   "
191662|NCT01055626|"~     Obesity is a serious medical problem because it increases the risk of cardiovascular disease~     (CVD), type 2 diabetes mellitus, and certain forms of cancer. The definition of obesity is~     based on an excess of body fat, not of BMI. However, BMI is the reference used to establish a~     graded classification of weight relative to height. Although BMI is widely used as a simple~     surrogate measure of body fat and has been shown to correlate closely with adiposity, it~     would be more appropriate to determine body fat percentage and to use this value for~     classification purposes. The present study contemplates the determination of the per cent~     body fat with the aim of establishing new diagnostic and therapeutic criteria according to~     the associated comorbidities.~   "
191663|NCT01055613|"~     This study compares an investigational contact lens care multi-purpose solution to a~     currently marketed multi-purpose solution.~   "
191664|NCT01055600|"~     This is a Phase IV study to evaluate eltrombopag concentrations in breast milk of nursing~     mothers taking marketed eltrombopag (PROMACTA®). Up to 10 subjects (mother-infant pairs) at~     as many as 10 study centers in the US will be enrolled. Nursing mothers who are registered~     with the PROMACTA Pregnancy Registry will be offered the option to participate in this trial~     if they continue to take commercial eltrombopag post-delivery and decide to breastfeed their~     infant. Information will be collected in a diary. Breast milk samples will be collected~     before and after infant feedings for a 24 hour period after eltrombopag dosing to evaluate~     the eltrombopag concentrations in the breast milk. Mothers will also be given the option to~     have a pharmacokinetic (PK) blood sample collected from the infant.~   "
191665|NCT01055587|"~     This study was designed to investigate, if new biomarkers may improve the early diagnostic of~     infections following major abdominal surgery and severe burn injuries.~   "
191666|NCT01055574|"~     The purpose of this study is to compare the physical capability outcomes of patients who~     undergo single-level ProDisc-L disc replacement with those of patients who undergo~     stand-alone, single-level anterior lumbar interbody fusion (ALIF). This study will be the~     first multi-center clinical study to use clearly measurable outcomes from physical tests to~     compare the results of lumbar disc arthroplasty with disc fusion.~   "
191667|NCT01055561|"~     The purpose of the study is to evaluate the safety and tolerability of acupuncture for~     patients with BPSD & healthy volunteers.~   "
191668|NCT01055548|"~     The aim of the pilot study is to explore and identify the issues of concern to parents whose~     babies have been cared for in a neonatal unit and exposed to imaging, its influence on~     diagnosis and information-giving process~   "
191669|NCT01055535|"~     This study will evaluate the safety and efficacy of Microplasmin administered as an~     intravitreal injection, in subjects with focal vitreomacular adhesion. Ultimately, it is~     believed that intravitreal microplasmin may offer physicians a safe agent for pharmacologic~     vitreolysis and induction of Posterior Vitreous Detachment (PVD) without the need for~     vitrectomy. This clinical study is justified because the study sponsor believes the potential~     benefits outweigh the potential risks, as outlined below.~   "
191670|NCT01055522|"~     This Phase II clinical study is an open-label, multicenter study of L19IL2 in combination~     with Dacarbazine in patients with metastatic melanoma.~      The study is divided in two parts: a phase IIa part, designed to establish the recommended~     dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine, as~     well as to determine the preliminary tolerability profile; the second phase IIb part~     evaluates the objective response rate (ORR) including a randomized study with a fixed dose of~     Dacarbazine with or without L19IL2, dosed at the RD determined in phase IIa.~   "
191671|NCT01055509|"~     The purpose of this study is to determine whether Cognitive Adaptation Training are effective~     in comparison with conventional treatment, focusing on social functions, symptoms, relapse,~     re-hospitalisation, and quality of life in outpatients with schizophrenia.~   "
191672|NCT01055496|"~     This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in~     combination with inotuzumab ozogamicin, an investigational product, in adults with~     CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects~     will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and~     prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine,~     cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab~     ozogamicin.~   "
191673|NCT01055483|"~     The study will determine the maximal tolerated dose (MTD) of panobinostat administered in~     combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients~     with relapsed or refractory acute myeloid leukemia (AML).~   "
191674|NCT01055470|"~     The purpose of this study was to compare the pain relieving action of the lornoxicam and~     diclofenac in patients of OA knee.~   "
191675|NCT01055457|"~     This study compares an investigational contact lens care multi-purpose solution to a~     currently marketed multi-purpose solution.~   "
191676|NCT01055444|"~     The purpose of the study is to explore the potential usefulness of a heated lidocaine 70~     mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder~     impingement syndrome~   "
191677|NCT01055431|"~     It has been estimated that 1 in 2 women expecting a baby will be diagnosed with iron~     deficiency. In turn iron deficiency can affect the health and wellbeing or both mother and~     child. Studies show that low iron stores prior to conception and low iron intakes during~     pregnancy may both be contributing to this problem. Although dietary supplements may be one~     solution, research indicates that daily compliance is low (Nguyen et al., 2008). Furthermore,~     prescribed iron supplements may result in uncomfortable side-effects, including constipation~     (Wulff & Ekstrom, 2003).~      It is been observed in Ethiopia that iron deficiency anemia is lower than average; a finding~     that has been attributed to regular Teff consumption (Gies et al., 2003). Teff (Eragrostis~     tef) is a staple food usually consumed in the form of Enjera (flat bread prepared using a~     range of cereals). Research has shown that Teff is a rich source of iron that is easily~     absorbed by the body.~      Although it is believed that regular Teff consumption may prevent to onset of iron deficiency~     anemia there is no research to support this. Therefore, the aim of the present study is to~     es-tablish whether incorporating Teff into the daily diet may be one way to improve blood~     profile and prevent the onset of iron deficiency anemia in expectant mothers. Study findings~     will demonstrate whether Teff may be an alternative source of iron that can be easily~     incorporated into the daily diet of both pregnant mothers and the lay public.~   "
191678|NCT01055418|"~     This investigation is interested in the effects of high dose vitamin C on endothelial~     function in healthy humans. A high fat meal will be utilized to induce endothelial~     dysfunction. It is hypothesized that, via antioxidant actions, vitamin C will reverse these~     effects and in turn improve blood flow- the involvement of nitric oxide suggests that this~     could extend to cerebral blood flow. This will be monitored by trans cranial doppler flow~     meter and near infrared spectroscopy.~   "
191679|NCT01055405|"~     Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of~     pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric~     oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries~     of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary~     disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary~     hemodynamics and increase exercise tolerance in this condition.~   "
191680|NCT01055392|"~     Lithium salts have been used for the treatment of psychiatric disorders for over five~     decades, mostly as a mood-stabilizing drug. Recent evidence points to the inhibition of the~     enzyme glycogen synthase kinase-3beta (GSK3) as one of its mechanisms of action. The~     overactivity of this enzyme has been implicated in the pathogenesis of Alzheimer's disease~     (AD), given its involvement in mechanisms related to the hyperphosphorylation of Tau protein~     and the production of beta-amyloid peptide. These are key events leading respectively to the~     formation of neurofibrillary tangles and senile plaques, which are the neuropathological~     hallmarks of the disease. Several in vitro and animal studies have shown that the inhibition~     of GSK3 by lithium and other agents attenuates these pathological processes, reinforcing the~     notion that GSK3 is a likely target for future disease-modifying therapies for AD. Indeed, a~     recent study published by our group showed that chronic lithium use is associated with a~     decrement in the expected prevalence of dementia, in a sample of elderly individuals with~     bipolar disorder. To investigate this putative neuroprotective effect in a prospective way,~     the investigators started 24-month randomized, double-blinded controlled trial of lithium for~     the prevention of dementia in a sample of elderly individuals with amnestic mild cognitive~     impairment (MCI), a condition associated with increased risk for the development of AD. The~     clinical and biological outcomes of this trial include the attenuation of cognitive deficits,~     and the modification of certain biological markers of the disease (as measured in the~     cerebrospinal fluid, leukocytes and platelets). The objective of the present application is~     to enable the extension of this ongoing trial to an additional 2-year follow-up. A longer~     follow-up (48 months) will increase the statistical power to ascertain the primary outcome~     variables of this study, particularly the con-version from MCI to Alzheimer's disease. This~     will warrant a more consistent conclusion about the potential of lithium treatment in the~     prevention of dementia, in addition to a better evaluation of safety and tolerability~     profiles of the long-term use of lithium in older individuals.~   "
191681|NCT01055379|"~     The primary endpoint for this study is the clinical response after 12 weeks of treatment,~     defined as a change in total score from baseline depressive symptoms as measured by the Beck~     Depression Inventory-Amended (BDI-IA) total score.~   "
191682|NCT01055366|"~     The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from~     prior pharmacotherapy in patients with open-angled glaucoma.~   "
191683|NCT01055353|"~     Evaluation of target organs damage in hypertensive patients with no known cardiovascular (CV)~     or renal disease, stratified according to level of blood pressure control~   "
191684|NCT01055340|"~     This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral~     or better than placebo in lowering ambient glucose levels during a graded glucose infusion~     (GGI) and that a single dose of OXM will lead to a statistically significant increase in the~     sum of the plasma βOHB + AcAc levels compared to placebo.~   "
191698|NCT01055145|"~     Fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant TB~     (MDR-TB). Among them, levofloxacin and moxifloxacin has been used most widely. However, there~     is no study to directly compare the efficacy of levofloxacin and moxifloxacin among MDR-TB~     patients. The investigators will compare the efficacy of levofloxacin and moxifloxacin~     through a prospective multicenter randomized open label phase III trial.~   "
191685|NCT01055327|"~     In 2007 a case control study was completed within the EUROCAT European network of congenital~     anomaly registers to test the hypothesis that first trimester lamotrigine monotherapy~     exposure is associated with an increased risk of isolated oral clefts. This study found no~     statistically significant increased risk of oral clefts compared with other defects following~     lamotrigine exposure in the uterus. The EUROCAT Antiepileptic Drug (AED) Database,~     established for the original case control study in 2007, will now be expanded to include an~     additional five to six years worth of data. These data will provide greater power to~     investigate the risk of isolated oral clefts, specific cleft types and potential associations~     with additional specific malformation types (e.g. neural tube defects). Data on cases of~     isolated oral clefts registered between 1993 and 2012 will be extracted from EUROCAT member~     registers meeting set inclusion criteria (ensuring completeness of outcome and exposure~     data). The primary comparison group will include all non oral cleft, non chromosomal~     malformations as the registers do not collect data on non malformed infants. This study will~     also be powered to include a second control group of chromosomal malformations, very unlikely~     to be associated with medication exposure. Data on exposure to anti-epileptic drugs (AEDs)~     during the first trimester of pregnancy will be extracted along with other key covariates~     including age of mother, history of epilepsy and gestational age of the infant. Primary~     analyses, using logistic regression, will compare the lamotrigine monotherapy versus no AED~     use across case and control groups and a secondary analysis will compare lamotrigine~     monotherapy versus other AED monotherapy (with and without valproate). Data will also be~     monitored for patterns of lamotrigine exposure across additional specific malformation groups~     of interest.~   "
191686|NCT01055314|"~     This randomized pilot clinical trial is studying the side effects and how well giving~     temozolomide and cixutumumab together with combination chemotherapy works in treating~     patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     temozolomide and cixutumumab together with combination chemotherapy may kill more tumor~     cells.~   "
191687|NCT01055301|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Biological therapies, such as thalidomide and lenalidomide, may~     stimulate the immune system in different ways and stop cancer cells from growing. Drugs used~     in chemotherapy, such as dexamethasone, cisplatin, doxorubicin hydrochloride,~     cyclophosphamide, etoposide, and melphalan, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Combining~     chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses~     of chemotherapy drugs and kill more cancer cells. Giving bortezomib, thalidomide, and~     combination chemotherapy before and after transplant and lenalidomide after transplant may be~     an effective treatment for multiple myeloma.~      PURPOSE: This phase II trial is studying how well giving bortezomib, thalidomide, and~     lenalidomide together with combination chemotherapy and autologous stem cell transplant works~     in treating patients with newly diagnosed multiple myeloma.~   "
191688|NCT01055275|"~     The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician~     experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and~     performance.~   "
191689|NCT01055262|"~     The objectives of this study are to evaluate the dermal safety and on-body temperature of a~     disposable heatwrap product when worn while in a supine position for five consecutive days.~     The product will be worn on the back for approximately 8 hours per 24 hour period.~   "
191690|NCT01055249|"~     Single centre, subject and observer blinded, placebo controlled, cross-over study of the~     effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR)~     induced pain and inflammation in healthy volunteers conducted in two segments and using an~     intra-individual comparison of application areas.~   "
191691|NCT01055236|"~     Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are~     reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects~     Hydroxyzine should be used in the prevention of these symptoms.~   "
191692|NCT01055223|"~     Treatment with thiazolidinediones (TZD) has recently been reported to possibly increase the~     risk of fractures in a randomized trial exploring the efficacy of rosiglitazone (RSG),~     metformin, or glyburide encompassing 4360 patients with type 2 diabetes.~      It is hypothesized that spironolactone, a diuretic that is broadly used for the treatment of~     fluid retention and edema associated with TZD, has a potential protective effect against bone~     fractures. However, to our knowledge, this has not been tested in diabetic patients treated~     with TZD. Amiloride is another diuretic that shares with spironolactone the anti~     mineralocorticoid ion gated channels activity and will be analysed in this study with regard~     to possible protective effect against bone fracture in combination with TZD.~      This study is a nested case-control study conducted among type 2 diabetes subjects exposed to~     TZD. The study aims to explore if the risk of fracture is reduced among type 2 diabetic~     subjects exposed to spironolactone and TZD. The study will compare the odds of any low impact~     fracture, and hand, foot, upper arm, wrist, and hip fracture incidence in subjects treated~     with TZD+spironolactone and TZD+amiloride compared to subjects treated with TZD only.~      The study population will consist of type 2 diabetes patients aged 18 -65 years old exposed~     to TZD. To be eligible for the study, a subject must have had at least one International~     Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months or at~     least 12 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO] or troglitazone)~     during their follow-up time available in the database.~   "
191693|NCT01055210|"~     An evaluation of the role of resting and exercise cardiac output measurement, by the inert~     gas rebreathing method, in optimisation of patients with cardiac resynchronisation~     pacemakers.~   "
191694|NCT01055197|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an~     effective treatment for extensive stage small cell lung cancer.~      PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain~     works when given with or without radiation therapy to other areas of the body in treating~     patients with extensive stage small cell lung cancer.~   "
191695|NCT01055184|"~     Unlike most influenza viruses, the 2009 H1N1 virus has affected people between 5 and 40 years~     old more often than people 60 years old or older. It may be that older people have had~     greater exposure to previous strains of H1N1 influenza, and this previous exposure protects~     them from infection. This study will examine how older people respond to a version of the~     H1N1 virus vaccine that includes a live, noninfectious version of the virus.~   "
191696|NCT01055171|"~     The purpose of this study is to examine the effect of propranolol versus placebo on craving,~     distress and cue reactivity to trauma and alcohol cues.~   "
191699|NCT01055132|"~     The purpose of this study is to determine the relative performance of a new daily disposable~     toric soft contact lens against a daily disposable toric contact lens currently available in~     market, specifically with regards to the comfort and vision with the lens.~   "
191700|NCT01055119|"~     The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects~     behavior and cognition in children with attention deficit hyperactivity disorder.~   "
191701|NCT01055106|"~     The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3~     regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.~   "
191702|NCT01055093|"~     The aim of the prospective observational GDC-Study in patients with newly diagnosed diabetes~     mellitus aged 18-69 years at inclusion into the study is to characterize in detail the~     clinical, metabolical and immunological phenotype and monitor the progression of the disease~     and to compare the phenotype to glucose tolerant humans of similar age, body mass and sex~     distribution.~   "
191703|NCT01055080|"~     The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or~     essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk~     based formula is effective in the prevention of type 1 diabetes associated beta-cell~     autoimmunity in children at genetic risk of type 1 diabetes.~   "
191704|NCT01055067|"~     This is a multicenter, single-arm study for safety and efficacy.~   "
191705|NCT01055054|"~     Periodic analyses of our extensive database with regards to different surgical procedures for~     severe obesity and different obesity co-morbidities will be of benefit to our severely obese~     patients as well as to others world-wide.~   "
191706|NCT01055041|"~     The purpose of this study is to know the effect of another controller medication add on to~     the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and~     compliance in patients of moderate to severe persistent bronchial asthma.~   "
191707|NCT01055028|"~     This is an open-label, single-arm, multi-center, Phase 2 study with Paclitaxel in combination~     with Bevacizumab in patients with Unresectable or Metastatic Angiosarcoma. The study aims to~     determine the safety and effectiveness of combining two drugs Paclitaxel and Bevacizumab in~     the treatment of Angiosarcoma that cannot be removed by surgery, or has spread to other parts~     of your body. The primary objective is to evaluate 4month non progression rate. The secondary~     objective is to evaluate overall response rate after 3rd and 6th cycle, median duration of~     response, 6th and 12th month survival, toxicity of Paclitaxel and Bevacizumab combination,~     toxicity of maintenance Bevacizumab and to collect paraffin-embedded tumor blocks for~     angiogenesis markers and tissue microarray.~   "
191708|NCT01055015|"~     This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients~     who have undergone primary unilateral total knee arthroplasty~   "
191709|NCT01055002|"~     This is a pilot study of a protocol for inducing a falciparum malaria infection in healthy~     volunteers in order to test the activity of novel agents being developed as drugs for the~     treatment of uncomplicated malaria. In this pilot study, 16 healthy male volunteers will be~     administered a low level malaria infection via infected human red blood cells. After 6 days~     they will be administered one of two registered antimalarial treatments (8 volunteers for~     each treatment) in order to define the rate of clearance of the infection. This information~     will be used to design similar future studies for the initial assessment of the efficacy of~     novel antimalarial drugs in development.~   "
191710|NCT01054989|"~     The combination of impaired insulin sensitivity and insulin secretion is thought to be the~     basis of type 2 diabetes. Increased free fatty acids levels impair insulin action in muscle~     and liver, but also systemic inflammation processes play a role in the development of insulin~     resistance.~      This study compares the effects of fat and inflammation on insulin sensitivity, systemic~     inflammation, energy metabolism, vascular system and neural function in healthy humans.~   "
191711|NCT01054976|"~     This study will examine whether the administration of galantamine is effective for~     improvement of attention and more effective for patients with serious disturbance of~     attention by administering galantamine to patients with Alzheimer's dementia and performing~     an attention test on baseline, week 4 and 12.~   "
191712|NCT01054963|"~     Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a~     solution to the common problem of delayed treatment. Early peer support may result in~     improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the~     first two years post-diagnosis. This study involves the development and testing of a peer~     mentor training initiative as one part of an intervention study for people with early IA~     (EIA). Peer mentors will be trained and assessed to provide one-on-one support (information,~     emotional, feedback) to individuals who have recently been diagnosed with IA. This is one~     part of an intervention study. The other part is called Peer to Peer Mentoring: Facilitating~     Individuals with Early Inflammatory Arthritis to Manage their Arthritis - Peer Mentoring~     Program.~   "
191713|NCT01054950|"~     Food allergies are becoming more prevalent with more children being diagnosed with food~     allergies each year. Food allergies place a tremendous burden not just on the patient but on~     his/her family as well. In an attempt to provide better care to the investigators patients,~     the investigators would like to determine if regular contact with our food allergy nurse has~     a positive effect on a family's perceived quality of life.~   "
191714|NCT01054937|"~     The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single~     dose administration in healthy volunteers.~   "
191715|NCT01054924|"~     The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the~     Invendo C20 Colonoscopy System~   "
191716|NCT01054911|"~     The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor~     removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage~     allowing for successful surgery. Therapy will be administered orally and the response of the~     tumor will be assessed using CTs or MRIs.~   "
191717|NCT01054898|"~     The purpose of this study is to determine if a telephone social support and empowerment~     intervention is more effective than usual community services in improving the mental health~     of community-dwelling women abused by their intimate partners.~   "
191718|NCT01054885|"~     The Purpose of this study is to assess the efficacy and safety of two strengths of the~     FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)~   "
191721|NCT01054846|"~     -  To test the hypothesis if provision of helmet education and free helmet distribution~          will significantly increase helmet use in preschool children of low-income families~          compared to those children receiving helmet education without free helmet distribution;~        -  To test the hypothesis if helmet users in preschool children will significantly reduce~          head and facial injuries compared to those non-helmet users~   "
191722|NCT01054833|"~     Urinary incontinence which is a major health issue in women affects 30-40% of older women.~      Surgical treatments for SUI have undergone many modifications in the last century.~      The Needleless Sling System is a one incision, minimally invasive, surgical procedure that~     has had great acceptance in Europe and has recently received FDA Clearance for use in the~     United States.~      We will evaluate effectiveness and patient reported outcomes for Needleless® sling system~     (Neomedic International).~      This is a prospective, multicenter, registry. Up to 150 women will be enrolled from up to 3~     registry sites.~      Patients will be evaluated at baseline, peri-operatively, and post-operatively up to 2~     months, up to 6 months and at 12 months.~      Effectiveness evaluations will include a standing stress test (objective cure), SANDVIK~     questions (subjective cure) & I-QOL (quality of life measure).~      Other evaluations will include type of anesthesia, concurrent surgery, operative time,~     post-operative pain, length of hospital stay, returning to usual activities, change of lower~     urinary tract symptoms (BFLUTSSF, voiding diaries), goal achievement and patient~     satisfaction.~   "
191723|NCT01054820|"~     Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been~     studied extensively in the setting of acute back strain. This study is being conducted as an~     initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In~     particular, this study is expected to provide information about the amount of improvement in~     back strain among subjects using the FLECTOR Patch, which may then be used to inform~     subsequent studies.~   "
191724|NCT01054807|"~     The purpose of this investigation is to compare the fit characteristics and vision attributes~     of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.~   "
191725|NCT01054794|"~     This is a prospective study of temporary gastric mucosal electrical stimulation (tGES) in 30~     patients with gastroparesis (GP). After a 7 day baseline assessment of symptoms, subjects~     will have an endoscopically-placed tGES lead implanted into the mucosa of the antrum. This~     lead is connected to a thin wire that runs up the esophagus and out the nostril, similar to a~     nasojejunal feeding tube, although much thinner. It is then attached to a programmable~     battery pack which provides the desired level of stimulation.~      Patients will then be randomized to 7 days OFF or 7 days ON stimulation in a double-blind~     fashion. After 7 days, subjects will crossover to the other study arm (ie ON patients will be~     switched off; OFF patients will be switched on). Symptoms and QoL measures will be assessed~     at baseline, ON, and OFF periods. Serum ghrelin and other hormones, as well as EGG will be~     assayed after 6 days in each arm.~   "
191726|NCT01054781|"~     The purpose of this study is to evaluate the complete response (CR) rate after Intensified~     1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL~   "
191727|NCT01054768|"~     The purpose of this study is to determine whether alpha-lipoic acid and acetyl-L-carnitine~     will lower systemic inflammation in patients with Sickle Cell Disease by reducing oxidative~     stress, which will result in a decrease in the frequency of vaso-occlusive pain episodes and~     improve their quality of life.~   "
191728|NCT01054742|"~     The purpose of this observational study was to provide summary data from participants who~     relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care~     PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received~     retreatment during Part 2 of the study. Relapse was defined as having a positive virology~     result at the Week 24 post-treatment follow-up, after a negative result at the Week 24~     end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were~     measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.~   "
191729|NCT01054729|"~     Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100~     mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B~     status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg~     active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in~     order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day~     0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study~     which continued for 48 weeks. Participants were evaluated for sustained virologic response~     (SVR) for an additional 24 weeks following completion of study treatment.~   "
191730|NCT01054716|"~     This study will collect whole blood samples from pregnant subjects who are RhD negative by~     serology to develop an assay for RHD determination of the fetus.~   "
191731|NCT01054703|"~     Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access~     system~   "
191732|NCT01054690|"~     This study is a single blinded (Outcome Assessors), multicenter randomized controlled study~     designed to investigate if a silver alloyed urinary catheter with antibacterial properties~     can reduce the incidence of catheter acquired urinary tract infections in patients undergoing~     elective surgery. Patients requiring urinary catheterization will be randomized into two~     groups and receive either the silver alloyed catheter (test) or a silicone catheter~     (control).~   "
191733|NCT01054677|"~     Main aim and objective~      The aim was to present the treatment of infectious diseases in elderly, especially in nursing~     homes and further to evaluate the effect of an intervention package aiming at improving~     treatment with antibiotics in Swedish nursing homes~      Specific objectives~        -  Present the treatment patterns regarding infectious diseases, including gender aspects~          in elderly, especially in nursing homes.~        -  Through focus group discussions elucidate the decision making process in nursing homes~          and target the intervention.~        -  Based on the above information develop an educational intervention to contribute to the~          improvement of the prescribing of antibiotics in nursing homes~        -  Evaluate the effect of the intervention on quality of prescribing, knowledge and~          attitudes in relation to available guidelines~   "
191734|NCT01054664|"~     To assess the incidence of occult hepatitis C virus in hemodialysed patients with mild~     impairment of liver enzymes~   "
191736|NCT01054638|"~     Cardiovascular disease (CVD) has been associated with HIV infection. However, it is uncertain~     whether increased CVD rates are associated with HIV-related factors (e.g., HIV-infection or~     highly active antiretroviral therapy (HAART) may worsen dyslipidemia) or reflect differences~     in the prevalence of underlying risk factors for CVD. Furthermore, the association between~     initiation and duration of HAART exposure and CVD risk, including which specific drugs within~     the HAART classes may contribute to the increased risk, is unknown. The primary objectives of~     the study are therefore:~      1. To estimate the absolute and relative incidence rate (IR) of CVD claims-based diagnoses~     among a cohort of adult patients from a large managed care population with a claims diagnosis~     of HIV, AIDS, or AIDS-related complex (ARC) during periods of exposure to:~        -  Any HAART compared to no HAART exposure~        -  HAART class [i.e., NRTIs, NNRTIs, PIs, and Other (i.e., fusion inhibitors)] compared to~          no HAART class exposure~        -  Specific NRTI medications compared to no specific NRTI exposure~   "
191737|NCT01054625|"~     This study is to support current and future Zalutumumab studies by increasing the~     Pharmacokinetic (PK) knowledge of the drug. PK is the study of how a drug is absorbed (taken~     up), distributed (moved around), metabolised (broken down) and excreted (removed) by the~     body, in relation to time. The first PK trial only went up to 8 mg/kg, and, as there has been~     some indication that the PK profile for the higher and lower doses is different, this needs~     to be further evaluated. Furthermore, there is a need for more PK data on dosing with~     16mg/kg.~      The aim with this study is therefore to evaluate the PK profiles at different doses of~     Zalutumumab and the amount of drug in the blood at different time points after single and~     multiple doses. The results of this study, combined with data from completed and ongoing~     Zalutumumab studies, will enable us to provide patients with an effective treatment option~     which may significantly prolong their survival and/or improve their quality of life.~   "
191738|NCT01054612|"~     Currently there is no technique to produce thin (0.004-0.01 mm) serial sections of large~     fresh tissue specimens that are suitable for high-resolution in situ protein/gene expression~     studies without ice artifact or fixation-induced molecular damage. Traditional frozen~     sectioning preserves protein and nucleic acid structure, but the inherent ice artifact~     precludes reconstruction of protein and mRNA expression patterns in 3-dimensions. Since the~     limitations of the existing sectioning techniques result from the fact that they rely on~     mechanical cutting which in turn require the tissue to be stiff, we suggest a new approach to~     cut tissue via an electro erosion process that utilizes focus radio frequency (RF).~   "
191739|NCT01054599|"~     Many patients with epilepsy have memory deficits in the setting of otherwise normal~     intelligence. Unfortunately, the treatment options for memory dysfunction in patients with~     epilepsy are limited. The investigators are conducting a study to evaluate the effects of~     memantine for the treatment of verbal memory dysfunction in subjects with~     localization-related seizures. The study involves randomization to memantine therapy or~     placebo, with cognitive testing and EEG pre- and post-treatment, as well as after an~     open-label memantine treatment phase.~      The primary aim of this study is to evaluate the efficacy of memantine for the treatment of~     verbal memory dysfunction in subjects with left temporal lobe epilepsy. The investigators~     expect that verbal memory task performance will improve in those taking memantine, but not in~     those taking a placebo.~      The investigators propose that the expected benefit of memantine is specific to verbal memory~     in subjects with left temporal lobe seizures, rather than representing an overall improvement~     in cognitive function. The investigators expect no improvement on other cognitive tasks in~     either the memantine or placebo groups.~      The investigators will evaluate whether subjects with left temporal lobe epilepsy and memory~     difficulties have self-reported improvement in memory while taking memantine. The~     investigators expect improvement of self-rated memory function on the Quality of Life in~     Epilepsy Patient Inventory (QOLIE-89) in the memantine group, but no change on this scale in~     the placebo group.~   "
191740|NCT01054586|"~     APV10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and~     tolerability of fosamprenavir/ritonavir (FPV/RTV) at reduced doses over 14 days in~     HIV-infected subjects with mild to moderate hepatic impairment (HI). Based on these data, two~     new regimens have recently been approved by the EMEA and FDA in these patient groups; FPV~     700mg BID/RTV 100mg QD for those with mild HI (Child-Pugh score 4-6) and FPV 450mg BID/RTV~     100mg QD for those with moderate HI (Child Pugh score 7-9). The Committee for Medicinal~     Products for Human Use (CHMP) has requested longer-term safety data among this hepatically~     impaired HIV-infected population who have received the recently updated FPV/RTV dosing~     regimens.~      An observational cohort study will be conducted using routinely collected data in three~     European HIV patient cohorts with a high proportion of hepatitis co-infected individuals.~     Patients who received FPV/RTV will be followed to address the following objectives.~      Primary: To assess the safety and tolerability of FPV/RTV-based ART in subjects with mild to~     moderate hepatic impairment.~      Secondary: A). To compare the safety and tolerability of FPV/RTV-based ART in subjects with~     mild to moderate hepatic impairment when compared to FPV/RTV-based ART in hepatitis B (HBV)~     or hepatitis C (HCV) co-infected subjects with normal hepatic function. B). To compare the~     safety and tolerability of FPV/RTV-based ART to lopinavir/ritonavir LPV/RTV-based ART in~     subjects with mild to moderate hepatic impairment.~   "
191741|NCT01054573|"~     The purpose of this study is to provide access to telaprevir for patients from the control~     group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and~     tolerability of telaprevir in combination with standard treatment will be evaluated.~   "
191742|NCT01054560|"~     The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR~     Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval~     System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™~     Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.~   "
191743|NCT01054547|"~     This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated~     ropivacaine formulations.~   "
191744|NCT01054534|"~     Determine the ability of real-time ultrasound with fusion technology of prior acquired MRI of~     the pelvis to guide a needle to the second sacral foramen using the posterior approach and~     place a interstim lead.~   "
191788|NCT01053962|"~     This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose~     ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD)~     effects of SP-304 in patients with chronic idiopathic constipation.~   "
191745|NCT01054521|"~     Currently, there are several alternative treatments for patients with chronic rhinitis (CR)~     who failed medication. Although, most of the researches have been focusing on~     temperature-controlled RF (TCRF), the cost is a major limitation for applying it worldwide.~     The investigators objective of this study is to compare the subjective and objective outcomes~     of Bipolar RF (BRF) with the more popular TCRF for CR treatment. The investigators~     hypothesized that both have equivalent outcomes but with less operative time and potentially~     at lower cost.~   "
191746|NCT01054508|"~     Cardiovascular disease (CVD) is associated with high levels of low-density lipoprotein (LDL)~     cholesterol and low levels of high-density lipoprotein (HDL) cholesterol.~      CVD results from 'hardening of the arteries' when there is a build-up of cholesterol in the~     walls of blood vessels. LDL is the main carrier of cholesterol in the body. LDL particles are~     responsible for transporting cholesterol that is deposited in vessel walls. LDL particles can~     also be altered in structure and turn into an irritant to the vessel walls. The body responds~     to the irritating effect of LDL by producing substances that result in inflammation. This~     sequence of events eventually leads to the vessels becoming permanently damaged. HDL has a~     protective role in CVD. It is associated with the enzyme paraoxonase which protects the body~     from the damaging effects of altered LDL particles.~      Nicotinic acid (niacin) has the ability to lower LDL levels and raise HDL levels thus~     reducing the incidence of CVD. Our study aims to show that niacin not only has good effects~     on cholesterol levels but is also able to reduce inflammation. Niacin is often poorly~     tolerated due to flushing side effect. Tredaptive is a formulation that combines niacin with~     laropiprant, an agent that reduces flushing hence improving tolerability and compliance.~      Patients who are receiving cholesterol-lowering medication and whose LDL levels have not~     reached the recommended target are recruited to the study. The study will be conducted at the~     Manchester Royal Infirmary. The study has two consecutive 16 week periods. In each period~     patients will be randomised to either tredaptive or placebo. They will attend for 5~     monitoring visits. Apart from the first visit, fasting blood samples will be taken from them~     during all subsequent visits.~   "
191747|NCT01054495|"~     Placebo control in acupuncture research is challenging and difficult. The primary objective~     of the study is to explore a study design comparing stimulation by real acupuncture needle,~     sham acupuncture needle and laser. The research question is whether a patient is capable of~     discriminate different stimulation modality when studying acupuncture stimulation for nausea~     in early pregnancy. The study is planned as a pilot study including 20 women in each of the~     three study groups, all-together 60 pregnant women. Intervention will consist of standardised~     15 minutes stimulation of acupuncture point pericardium 6 by, either two acupuncture needles,~     two sham acupuncture needle or two laser devices. All participating women are told that they~     will get different stimulation at an acupuncture point with potential effect on nausea. The~     women will record their daily symptoms during a 4 day run-in period, a 3 day intervention~     period, and thereafter a 4 day follow-up period after treatment in accordance with previous~     research methodology. In addition, the women will record how they experience the three~     different stimulations of acupuncture points. The results from the study could be important~     for planning of future studies where the blinding issue with regard to acupuncture is~     challenged.~   "
191748|NCT01054482|"~     This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy~     in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal~     induction strategy.~   "
191749|NCT01054469|"~     Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in~     patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP~     block will result in a significant reduction in pain scores and morphine requirements in the~     active group.~   "
191750|NCT01054456|"~     This study is designed to assess the safety and efficacy of palonesetron in preventing CINV~     (Chemotherapy-Induced Nausea and Vomiting) when administered to patients who have experienced~     either vomiting and or at least moderate nausea during their last cycle of low emetogenic~     chemotherapy.~   "
191751|NCT01054443|"~     This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging,~     parallel-group study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics~     of S-888711 in the treatment of subjects with immune thrombocytopenia. Eligible subjects will~     be randomized into one of four treatment groups to receive S-888711 0.5 mg, 0.75 mg, or 1.0~     mg or placebo.~   "
191752|NCT01054430|"~     The objective of this study is to assess the single dose pharmacokinetics of avanafil in~     subjects with hepatic impairment and in healthy control subjects.~   "
191753|NCT01054417|"~     A diagnostic laparoscopy is frequently used to confirm the diagnosis of appendicitis.~     However, laparoscopic criteria for determining appendicitis are not defined. If there is any~     doubt about the presence of an abnormal appendix, it is usually removed. However, an~     appendectomy of a negative appendix has a certain morbidity and for that reason it should be~     avoided. The purpose of this study is to establish laparoscopic criteria for the diagnosis~     appendicitis during diagnostic laparoscopy.~   "
191754|NCT01054404|"~     Increased brain bulk may be problematic during brain surgery for tumors because it may limit~     surgical exposure and access to the surgical site. Mannitol, an osmotic diuretic, is commonly~     given to alleviate brain bulk, and sometimes furosemide in a small dose is added if mannitol~     alone is insufficient. It is unclear if adding this furosemide truly helps to diminish brain~     bulk, and it is possible that furosemide may cause too much diuresis, leading to dehydration~     and its side effects (e.g., low blood pressure). Our purpose is to investigate what the~     effects of furosemide are in the setting of brain surgery for tumors, specifically with~     regards to decreasing brain bulk and/or causing dehydration.~      Study Hypothesis: The addition of furosemide to mannitol will result in improved brain~     relaxation in human subjects undergoing craniotomy for brain tumor resection than that seen~     with mannitol alone. However, the combination of mannitol and furosemide will also lead to~     more significant intravascular volume depletion than that seen with mannitol alone.~   "
191755|NCT01054391|"~     The purpose of this study is to determine whether the NEC device can effectively occlude the~     intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel~     patency~   "
191756|NCT01054378|"~     The temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will~     be easily detected by M-mode ultrasonography~   "
191757|NCT01054365|"~     In comparison to delayed hospital discharge, a strategy of early hospital discharge of~     patients who undergo single and multivessel stenting for type A, B, and C lesion(s) using~     thienopyridine and a hemostatic femoral closure device, is associated with similar clinical~     outcomes, but greater patient satisfaction and similar cost.~   "
191758|NCT01054352|"~     A single and multiple dose study to assess the safety of JNJ 38224342 compared to placebo in~     healthy volunteers and in volunteers with seasonal allergies.~   "
191759|NCT01054339|"~     This study will evaluate the safety and efficacy of a recombinant adeno-associated virus~     vector expressing alpha-1 antitrypsin in patients with alpha-1 antitrypsin deficiency. Three~     groups of three subjects each will receive the study drug by intramuscular injection, with~     progressively larger doses in the second and third groups.~      Funding Sources - FDA OOPD and NIH NHLBI~   "
191760|NCT01054326|"~     The objective of this study was to evaluate and compare two different post-surgical~     rehabilitation strategies, Rehabilitation supervised by a physical therapist including~     exercises with progressive early activation of the rotator cuff versus basic home exercises~     regarding shoulder function, pain, health related quality of life and return to work after~     arthroscopic subacromial decompression.~   "
191761|NCT01054313|"~     The goal of this clinical research study to find the highest tolerated dose of the~     combination of Taxotere (docetaxel) and Rapamycin (sirolimus) when given to patients with~     advanced cancer.~      Researchers also want to find highest tolerated dose of the combination of docetaxel,~     sirolimus, and prednisone when given to patients with advanced prostate cancer. The safety of~     both drug combinations will also be studied.~   "
191762|NCT01054300|"~     This is a Phase 1 pharmacokinetic, pharmacodynamic study to understand the manner in which~     the body responds to, as well as how the drug is handled by the body, with once vs twice~     daily dosing of ertugliflozin (PF-04971729, MK-8835) in participants with type 2 diabetes.~   "
191763|NCT01054287|"~     The aim of this study is to evaluate the effect of a multifactorial falls prevention program~     in an acute internal medicine ward.~   "
191764|NCT01054274|"~     Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from~     cancer in China and sixth worldwide. Although the prognosis of surgical resection for~     esophageal cancer has been improved, more than 50% of such patients are inoperable and have~     to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the~     predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia~     and improve the quality of life of such patients, brachytherapy has previously been utilized.~     Recently, stent placement has been widely accepted to be an option for palliation of the~     symptoms due to the esophageal strictures. Brachytherapy and esophageal self-expanding stent~     insertion have longer benefit. Stent insertion provides fastest improvement of~     dysphagia.However, recurrence of the neoplastic stricture remains a challenge after stent~     placement, complications in later setting occur and require further endoscopic treatment.~     Brachytherapy has slower onset of benefit but has fewer complications and longer benefit.To~     combine the advantages of the immediate relief of the esophageal dysphagia with the stent~     placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I~     seeds has been developed in the authors' institute. The technical feasibility and safety with~     this new stent has been demonstrated to be adequate in a healthy rabbit model. And a~     small-sample and unicentric prior clinical trial in the authors' institute certificated the~     novel esophageal stent can relieve the dysphagia caused by advanced esophageal cancer rapidly~     and improve the quality of life markedly. This current multicentric randomized clinical trial~     is further studying the novel esophageal stent loaded with 125I seeds to see how well they~     work compared with a conventional covered stent in patients with malignant dysphagia caused~     by advanced esophageal cancer.~   "
191765|NCT01054261|"~     The objective of this study is to compare the pharmacokinetics of avanafil in subjects with~     mild and moderate renal impairment and to assess the safety and toleration of avanafil in~     subjects with mild and moderate renal impairment.~   "
191766|NCT01054248|"~     This is a randomised, open label trial, comparing standard dose of~     dihydroartemisinin-piperaquine (DP) with standard fixed artesunate-mefloquine regimen (MAS3)~     and with a longer regimen of artemether-lumefantrine (ALN+) in the treatment of uncomplicated~     malaria in pregnant women. The sample size is 335 women in each arm which would be 1005 women~     in total. Pregnant patients in 2nd and 3rd trimester with acute uncomplicated malaria who~     meet eligibility criteria will be asked to participate in the study. The primary objective is~     to determine if the efficacy of DP and MAS3 are superior to ALN+ in the treatment of~     uncomplicated malaria in pregnancy. The study will also incorporate a dense pharmacokinetic~     study of mefloquine and artesunate (15 women in the MAS3 arm) and a population~     pharmacokinetic study for mefloquine, piperaquine and lumefantrine.~   "
191767|NCT01054235|"~     The general objective of this study is to evaluate prenatal care in the specific context of~     rural China. It also aims to define the optimal content of prenatal care for the context of~     rural China, to evaluate the effect of such prenatal care on infant and maternal outcomes,~     using a community based, well designed controlled trial in rural counties. Finally, it aims~     to describe the process of conducting a controlled study using community resources.~   "
191768|NCT01054222|"~     This is an open-label extension study intended for subjects who have previously completed~     study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the~     investigator as being suitable for the extended use of Fesoterodine. Data from this study~     will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older~     subjects from Portugal.~   "
191769|NCT01054209|"~     This study will demonstrate whether an electric warming mattress can reduce the number of~     patients who get cold and shiver after elective cesarean section.~      Peri-operative hypothermia (body temperature below 36 ºC) is a cause of post-operative~     complications and patient discomfort. Immediately post-operatively such discomfort is due to~     increased pain and shivering. Patients say that their time in the recovery ward is very~     stressful and this is prolonged if they become cold (hypothermic)or shiver. Subsequently,~     patients can suffer with increased risk of infections and delayed discharge from hospital.~      For patients (and their babies) having Cesarean sections it is important to start breast~     feeding as soon as possible, but being cold may delay this.~      For some types of surgery measures are put in place to stop patients becoming cold and~     thereby reduce the number of problems. However this is not the case with patients undergoing~     Cesarean sections because the special blankets through which hot air is blown to keep them~     warm are inappropriate for mothers giving birth by Cesarean section as it would make it~     difficult for a mother to have good skin-to-skin contact with her new baby immediately after~     delivery - an important part in the bonding process.~      A solution is to use a new warming mattress. This has been shown to be safe and effective~     with some types of surgery, but has not been tested in Cesarean sections.~      In the investigators study,the investigators will warm a group of patients undergoing planned~     Cesarean section and compare them to an unwarmed group to see if there is any difference~     primarily in post-operative temperature. Secondarily, the investigators will also look for~     differences in total blood loss, incidence of blood transfusion, wound infection, shivering,~     the immediate health of the baby, time taken to become fit for discharge from recovery,~     length of hospital stay and time to breast-feeding.~   "
191770|NCT01054196|"~     A) Phase 1: To determine the maximal tolerated dose (MTD) of lenalidomide that can be safely~     added to high-dose melphalan prior to autologous stem cell transplantation (ASCT).~      B) Phase 2: To determine whether the addition of high-dose lenalidomide to ASCT followed by~     maintenance standard-dose lenalidomide improves the response rate and duration of response~     for relapsed multiple myeloma (RMM).~   "
191771|NCT01054183|"~     This study seeks to assess the role of the GlideScope Ranger video laryngoscope in~     facilitating successful neonatal/pediatric intubation by pediatric critical care transport~     teams. The central hypothesis of this study is that the GlideScope Ranger video laryngoscope~     reduces the rates of failed intubation attempts by pediatric critical care transport teams.~     The aims of this project are designed to specifically: (1) Establish competencies for~     GlideScope Ranger video laryngoscopy-assisted intubation for pediatric and neonatal patients;~     and (2) Compare the intubation success rates for intubation using GlideScope Ranger video~     laryngoscopy and using conventional, direct laryngoscopy by pediatric and neonatal critical~     care transport teams.~   "
191772|NCT01054170|"~     The primary objective of the study is to evaluate structural changes effected by AD9668 in~     the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice~     Computed Tomography (MSCT)~   "
191773|NCT01054157|"~     to approve the expression of PGF2α receptors in hair follicle in ocular skin tissue,~     explaining the hypertrichotic effect of PG analogues as intraocular pressure lowering~     treatment.~   "
191774|NCT01054144|"~     The purpose of this research is to estimate the effectiveness of a response adapted approach~     with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed~     standard risk multiple myeloma. This means that participants will be given the study drug,~     lenalidomide but depending on how they respond to this drug they may also be given~     dexamethasone and/or prednisone to help with their treatment.~   "
191775|NCT01054131|"~     Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a~     solution to the common problem of delayed treatment. Early peer support may result in~     improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the~     first two years post-diagnosis. The whole intervention study comprises of two parts: The~     first part involves the development and testing of a peer mentor training initiative, which~     is called Peer to Peer Mentoring: Facilitating Individuals with Early Inflammatory Arthritis~     to Manage their Arthritis - Peer Mentor Training. The second part, which is the focus of~     this study, involves the delivery of a one-on-one peer support intervention from a trained~     peer mentor to an individual newly diagnosed with EIA. The feasibility and acceptability of~     the program will be determined, as well as the health outcomes following the participation of~     the program.~   "
191776|NCT01054118|"~     This study will assess the safety, tolerability, pharmacokinetics (explores what the body~     does to the drug), and pharmacodynamics (explores what a drug does to the body) of single~     doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in~     healthy overweight or obese adult male volunteers.~   "
191777|NCT01054105|"~     In the present study, the investigators want to investigate the prevalence of BMPR-2 gene~     mutations in the Korean PAH patients (Step-I) and to test that the PAH patients treated with~     iloprost inhalation solution (Ventavis®) would show hemodynamic response, especially assessed~     by exercise echocardiography (Step-II).~   "
191778|NCT01054092|"~     The primary objective of this study is to evaluate the long-term safety of ASP1941 in~     patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and~     pharmacokinetics of ASP1941 administered before or after food intake.~   "
191779|NCT01054079|"~     This phase II trial is studying how well cinacalcet hydrochloride works in treating men with~     recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering~     prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has~     not responded to previous treatment~   "
191780|NCT01054066|"~     The purpose of this program is to educate primary care physicians in four underserved clinics~     in eastern North Carolina about chronic kidney disease.~   "
191781|NCT01054053|"~     The main objective of the study is to estimate the proportion of children, born between the~     06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with~     a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4),~     before the first vaccination (T0), after the second MenBvac vaccination (6 weeks after the~     second vaccination), before the third MenBvac vaccination and after the third MenBvac~     vaccination (6 weeks after the second vaccination) and one year after the third menBvac~     vaccination.~   "
191782|NCT01054040|"~     The study will involve cardiac rehabilitation clients and will measure their weight, height,~     waist circumference and blood pressure comparisons between first and final visit (after 8~     weeks). A control group will receive usual care and an experimental group will receive usual~     care plus a portion control plate for their meals. Patients currently have their waist~     circumference, weight, height and blood pressure measured at their first visit (week 0) and~     at their final visit (week 8). This study would compare these three parameters at these same~     times (week 0 and week 8) between the control and experimental groups. The control group~     would receive the usual care while the experimental group would receive usual care plus be~     given a portion control plate at week 0.~      The hypothesis of this study is that subjects from the experimental group will have an~     average reduction in: (a) waist circumference by > 5%, (b) weight or BMI by > 5%, and (c)~     systolic and diastolic blood pressure by >10%. The subjects in the control group are~     hypothesized to show an average less than these targets for the experimental group.~   "
191783|NCT01054027|"~     The purpose of this study is to compare the dilating effect of 0, 1, 2 or 3 drops of~     mydriatic (pupil dilating) in premature infants undergoing routine retinal (eye) screening~     exams for Retinopathy of Prematurity (ROP).~   "
191784|NCT01054014|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics~     (how the drug is absorbed in the body, how it is distributed within the body and it is~     removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy~     volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and~     without food.~   "
191785|NCT01054001|"~     The investigators try to investigate the benefit of early administration (immediately after~     urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The~     investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men~     with on- demand sildenafil 100mg dosing from the early postoperative period (immediately~     after urethral catheter removal) with from the delayed postoperative period (3 months after~     RP).~   "
191786|NCT01053988|"~     The Purpose of this study is to assess the efficacy and safety of two strengths of the~     FF/GW642444 Inhalation Powder in subjects with chronic obstructive pulmonary disease (COPD)~   "
191789|NCT01053949|"~     The purpose of this study is to evaluate the response to pomalidomide and dexamethasone in~     relapse and refractory MM patients who are progressive and did not achieve at least a partial~     response to bortezomib and lenalidomide. This study will determine the efficacy and toxicity~     profile of 2 modalities of pomalidomide in patients with advanced myeloma, previously heavily~     treated characterized with adverse prognostic and that are in desperate need of novel~     therapeutics.~   "
191790|NCT01053936|"~     This study assesses the effects of a new formulation of bardoxolone methyl on eGFR in~     Patients with Chronic Kidney Disease and Type 2 Diabetes.~   "
191791|NCT01053923|"~     The purpose of this study is to establish a prospective database of anal canal and perianal~     cancer patients treated with IMRT and chemotherapy with curative intent at PMH for the~     purposes of investigating MRI-derived primary tumor parameters. Patients who decide to~     participate in this study will be treated according to standard treatment policies and~     radiation therapy planning protocols at Princess Margaret Hospital (PMH) with radiation~     therapy +/- chemotherapy. IMRT for all treatment phases of radiotherapy has been implemented~     as standard treatment. Surgery is reserved for salvage treatment.~   "
191792|NCT01053910|"~     The objective is to investigate the safety of ramipril 10 mg/day used in prevention of~     cardiovascular events in high-risk patients, including the criteria of the HOPE study.~   "
191793|NCT01053897|"~     The primary objective of this study is to assess whether intradermal injections of GBT009~     along full thickness incisions following surgery results in an improvement in scar~     appearance.~   "
191794|NCT01053884|"~     Study objectives To evaluate the safety of the echinocandin anidulafungin for prophylaxis or~     treatment of invasive fungal infections (IFI) in hematologic patients.~      Study design, Study conduct period Prospective, open label, phase II, one arm, single centre~     study October 2009 - September 2010~      Study population Twenty adult patients (≥ 18 years) with a hematologic disorder and an~     indication for antifungal prophylaxis or therapy, but a relative contraindication for azoles~     or polyenes due to hepatic and renal dysfunction respectively~      Methods and Main Out-come Variables Main Outcome Parameter Safety: Adverse events and changes~     of important laboratory parameters with clinical impact will be reported.~      Secondary Outcome Parameter Efficacy: In therapeutically use the outcome will be categorized~     into success or failure. For patients receiving anidulafungin as prophylaxis the number and~     rate of breakthrough infections will be documented.~      Risk assessment Treatment related adverse effects as reported in the approved physician~     prescribing information (usually mild and with an incidence of < 5%). Treatment failure due~     to resistant pathogens.~      Expected benefit from this study IFI is a major cause of death among hematological patients,~     especially those undergoing high dose chemotherapy. It is conceivable that anidulafungin is a~     new treatment option for patients in whom azoles or polyenes are relatively contraindicated.~   "
191795|NCT01053871|"~     This trial aims to compare the endomicroscopic image quality and sedation efficacy of~     propofol or midazolam with fentanyl.~   "
191796|NCT01053858|"~     To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the~     treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.~   "
191797|NCT01053845|"~     Several studies showed that activity of down inhibitor bundle is weakened in different~     painful pathologies as the fibromyalgy or the trigeminal nevralgy.~      The purpose of the protocol is to study the working of down inhibitor bundle at patients~     suffering of neuropathic pain.~   "
191798|NCT01053832|"~     Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.~   "
191799|NCT01053819|"~     In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely~     heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However,~     successful systemic treatment and subsequent clearing of psoriatic plaques may allow~     clinicians to better evaluate pigmented lesions, thereby increasing the likelihood of early~     identification and treatment of suspicious lesions such as nonmelanoma skin cancer and~     malignant melanoma.~   "
191800|NCT01053806|"~     To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in~     high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1~     who are considered to be at high risk due to unfavorable additional factors.~        -  To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk~          MDS patients.~        -  To evaluate the hematological improvement rate.~        -  To evaluate the cytogenetic response rate.~        -  To evaluate the Progression free survival (PFS).~        -  To assess Quality of life.~   "
191801|NCT01053793|"~     The purpose of this study is to determine the glycemic index of four varieties of potatoes~     and to determine the bioavailability of polyphenols contained in these potatoes.~   "
191802|NCT01053780|"~     Intercessory prayer can improve the outcome of pregnancies?~   "
191803|NCT01053767|"~     This study looks at the body's immune response to a GBS vaccine 2 years after the orginal~     vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody~     levels.~   "
191804|NCT01053754|"~     The study (forward-looking and opened) will concern 70 subjects having had a systemic~     prolonged treatment with corticosteroids for intestinal chronic inflammatory disease,~     recruited in the services of gastroenterology and endocrinology of the North Hospital of~     Marseille (France). The primary objective of the study is to estimate a new test, the long~     synacthen stimulation test, using an IM injection of 1 mg of delate synacthen, with regard to~     the definitive standard. Indeed, this long test could be realized in ambulatory conditions,~     and turn out more contributory than the definitive standard to estimate the capacities of~     answer of the adrenal glands in front of a prolonged stress, as it is the case during a~     surgical procedure for example.~      The secondary objectives are: 1) to determine the relation between the value of basal~     cortisol and the peak of stimulation of cortisol during short and long tests. This could~     allow to clarify better the conditions in which it is absolutely necessary to realize a~     dynamic test, 2) to determine the relation between cortisol assay in the plasma and in the~     saliva. The sample of saliva is simple and non-invasive, and presents the advantage to be~     able to be realized in ambulatory conditions and by the patient himself.~      The cortisonic withdrawal syndrome is another complication which can arise when a prolonged~     corticosteroid therapy is discontinued. Clinically, it looks like a chronic adrenocortical~     insufficiency, but with normal ranges of plasma cortisol. It is probably in touch with a~     physical dependence to the taking of above physiological doses of GC over a long period. Its~     physiopathology remains badly known, but could bring in a deficit of secretion of DHEA-S~     (dehydro-epiandrosterone sulphate), another hormone secreted by the adrenal glands. One of~     the secondary objectives of the study will consist in informing the variations of DHEA-S~     after a prolonged corticotherapy, in the basal state and after stimulation by the long~     synacthen stimulation test.~   "
191805|NCT01053741|"~     This research is being done to learn how seminal fluid affects the lining of the colon, and~     whether this might make it easier for HIV to get into the body and cause infection.~   "
191806|NCT01053728|"~     Primary Objective:~      - To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles~     of four formulations of SAR161271 in patients with T1DM.~      Secondary Objective:~      - To establish relative potency of SAR161271 compared with insulin glargine in patients with~     T1DM~   "
191807|NCT01053715|"~     The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents~     and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The~     study will also assess the kinds of determinants, including key transitional life events,~     that might impact HRQoL in this patient population.~   "
191808|NCT01053702|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of~     the efficacy of REGN475 in patients with pain due to thermal injury.~   "
191809|NCT01053689|"~     The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of~     Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis~     Pharmaceuticals Inc in healthy subjects, under fed condition.~   "
191810|NCT01053676|"~     The study is conducted as a randomized, non-blinded, 2-way crossover study. Target population~     is 60 Japanese healthy male adult subjects selected by screening examination which will be~     conducted within 4 weeks before the first drug administration of period 1 (before the~     hospitalization of period 1). Subjects will admit in the clinical institute on Day -3 and be~     discharged on Day 6 in each period. During hospitalization, standardized phosphate diet from~     Day -2 to Day 4 will start approximately 20 minutes before dosing. Subject will take about~     1300 mg of phosphate evenly at breakfast lunch and dinner for each day. Subject should~     consume at least 95% of a meal. Distilled water not to include phosphate will be used for~     drinking water and meal. Subjects are to drink at least 1 L of distilled water every day in~     clinic to make sure enough urine volume. The 24 hours urine collection will be conducted~     between Day -2 and Day 4 to investigate the urinary phosphate excretion.BAY77-1931 granule~     500 mg or Fosrenol chewable tablet 500 mg will be administered three times daily after each~     meal from Day 1 to Day 4. On day 4 single dose after breakfast will be administered. Study~     drugs will be administered immediately after each meal, that is within 20 minutes after start~     of each meal with 240 mL of distilled water. A Fosrenol chewable tablet 500 mg will be taken~     after chewing completely.~   "
191811|NCT01053663|"~     This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in~     3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection.~     Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days.~     Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous~     dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at~     day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration.~     Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.~   "
191812|NCT01053650|"~     Paracetamol is one of the most commonly used drugs in the world, indicated for the~     symptomatic treatment of fever and pain of mild to moderate. More precisely, it is a drug~     used to relieve pain and reduce fever. The objective of this study is to analyze whether a~     placebo effect occurs when you take paracetamol for pain, ie if the analgesic effect of~     paracetamol is partly due to the simple fact of taking a drug.~      Moreover, during the study you propose to do a saliva sample, optional, for biological~     research, pharmacogenetics, to assess how paracetamol is processed and eliminated in your~     body..~   "
191813|NCT01053637|"~     The purpose of this study is:~        -  To determine whether oral narcotic medication versus placebo improves the pain and~          anxiety scores for pediatric patients requiring laceration repair in the pediatric~          emergency department and receiving the standard of care with lidocaine treatment~        -  To evaluate for a statistical difference in pain scores in children during laceration~          repair~        -  To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children~          (STAIC) scores during laceration repair~   "
191814|NCT01053624|"~     This protocol has been designed to determine if tracheostomy performed immediately after lung~     operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk~     patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical~     ventilation and the number of respiratory complications.~   "
191815|NCT01053611|"~     The aim of this study is to compare the accuracy of the changes in CVI in response to a~     standardized noxious stimulus during various targeted pseudo-steady-state concentrations of~     remifentanil and various steady state level of BIS as guided by propofol effect compartment~     controlled TCI (closed-loop).~   "
191816|NCT01053598|"~     The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p~     for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB~     suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard.~      The Secondary objectives are:~        -  To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative~          patients~        -  To describe the results of the colorimetric methods in HIV-positive and HIV-negative~          patients~        -  To assess the time to detection of both NRA/NRA-p, REMA-p methods.~        -  To evaluate the feasibility of the NRA, NRA-p, REMA-p methods.~        -  To determine the rate of contamination of the NRA, NRA-p and REMA-p assays.~        -  To evaluate the proportion and the clinical relevance of NTM among TB suspects in a high~          TB and HIV prevalence setting.~        -  To provide capacity building for TB diagnosis in Mbarara.~   "
191817|NCT01053585|"~     Aims of research project:~      To identify key features of the gastro-esophageal junction (structure and function) that~     protects the esophagus from gastro-esophageal reflux investigated by combined high resolution~     manometry and magnetic resonance imaging.~      Hypothesis:~        1. Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric~          distension determine whether or not TLESR occurs; however~        2. Structural factors including separation of GEJ anatomy, intra-gastric distribution of~          the meal and secretions determine whether TLESR is accompanied by no reflux event, gas~          reflux (belching) or reflux of ingested food and gastric secretion ('true reflux').~        3. Initial findings by descriptive studies in healthy volunteers (study #1) and patients~          with mild to moderate gastro-esophageal reflux disease (study #2) will be further~          interrogated by a randomized, double-blind control trial of baclofen in patients with~          GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .~   "
191818|NCT01053572|"~     To evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in~     percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in~     patients with post lumbar surgery syndrome.~      To evaluate and compare the adverse event profile in all groups.~   "
191819|NCT01053559|"~     Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel~     Crohn's disease. Endoscopic healing is an important endpoint to measure response to~     treatment.~   "
191820|NCT01053546|"~     RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck~     cancer patients undergoing chemotherapy or radiation therapy.~      PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise~     therapy to see how well it works compared to late onset of swallowing exercise therapy in~     treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.~   "
191821|NCT01053533|"~     The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines~     for severe pandemic H1N1 influenza.~   "
191822|NCT01053520|"~     This is a Phase 1, randomized, open-label, single center, three period crossover study to~     determine the oral bioavailability of a new ABT-263 formulation relative to that of the~     current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately~     12 healthy female subjects will be enrolled in this study.~   "
191823|NCT01053507|"~     This study will evaluate the effectiveness of Treximet when taken for post traumatic headache~     by measuring any change in the number of headache days or any change in a subject's ability~     to think following treatment with study medication. Eligible subjects will complete 3 visits.~     Following Visit 1, subjects will treat with their usual medication and document headache~     symptoms and therapy in a Headache Diary. After 30 days, subjects will return for Visit 2 and~     be randomized (like the flip of a coin) to receive Treximet or matching placebo to treat at~     the same time each day. Treximet will be provided to treat any headache that occurs. Subjects~     will complete a daily Diary. After 30 days, subjects will exit the study at Visit 3.~   "
191824|NCT01053494|"~     This clinical trial studies massage therapy given by caregiver in treating quality of life of~     young patients undergoing treatment for cancer. Massage therapy given by a caregiver may~     improve the quality of life of young patients undergoing treatment for cancer~   "
191825|NCT01053481|"~     The purpose of this study is to determine whether increasing levels of serum 25(OH)Vitamin D~     as achieved by oral supplementation higher than the current recommendations are associated~     with a less negative bone calcium balance in post-menopausal Swiss women.~   "
191826|NCT01053468|"~     Breast cancer and its treatments can take a toll on the physical and psychosocial well-being~     of cancer survivors. Few interventions can help breast cancer patients improve their physical~     strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during~     chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer~     patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This~     trial will also give Southern Alberta breast cancer survivors an opportunity to participate~     in evidence-based programs designed to facilitate their health, breast cancer recovery, and~     disease-free survival.~      The investigators primary hypothesis is that women receiving the PA intervention resource kit~     will report a more positive change in self-reported PA at the end of chemotherapy treatments~     when compared to the group receiving standard materials.~   "
191827|NCT01053455|"~     Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants~     with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level~     of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP.~   "
191828|NCT01053442|"~     Several iron compounds are used for fortification, including ferrous sulphate and NaFeEDTA.~     The absorption profile of these may differ because of differences in their dissolution in the~     gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption.~     As these differences might lead result in varying reactions in the blood stream, the~     appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total~     iron in the plasma will be monitored over six hours in adult women. This is relevant as a~     spike of absorbed iron may increase non-transferrin-bound iron and this could be~     pro-oxidative or increase growth of pathogens. Hepcidin is a key mediator of iron absorption~     and will help explain the potential differences in the plasma iron profile.~      The use of stable iron isotope appearance curves to specifically detect the appearance of~     small amounts of absorbed iron in the blood and distinguish between circulating body iron and~     iron absorbed from the test meal was tested in a pilot study (EK 2008-23). This method is now~     used in a bigger sample to test the differences in absorption profile of ferrous sulphate,~     FePPi and NaFeEDTA given at fortification level with a meal.~   "
191829|NCT01053429|"~     This is a regulatory-required non-interventional pharmacovigilance study exploring the safety~     profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient~     population, thus, safety (and/or efficacy) signals will be checked at every visit during the~     contracted study period until the maximum study end date, per the protocol, of April 2010.~   "
191830|NCT01053416|"~     STUDY AIMS~        1. To determine the 10-year conversion rate from pigment dispersion syndrome (PDS) to~          pigmentary glaucoma (PG)~        2. To evaluate the possible protective effect of a Yag-laser iridotomy~   "
191840|NCT01053273|"~     The purpose of this study is to:~        -  evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low~          back and/or lower extremity pain in patients without post lumbar surgery syndrome or~          spinal stenosis and compare with fluoroscopically directed caudal epidural steroid~          injections.~        -  evaluate and compare the adverse event profile in all groups.~   "
191850|NCT01053143|"~     The purpose of this study is to assess the safety and immunogenicity of one dose of A/H1N1~     non-adjuvanted pandemic vaccine to support registration of the vaccine in India.~      Primary Objective:~        -  To describe the safety profile (injection site reactions and systemic events) of the~          vaccine within 21 days following vaccination, and serious adverse events throughout the~          study in all subjects~      Secondary Objectives:~        -  To describe the immune response to the vaccine 21 days after vaccination by~          hemagglutination inhibition (HAI) testing in all subjects~        -  To describe the antibody persistence 6 months after vaccination by HAI testing in all~          subjects.~   "
191831|NCT01053403|"~     The purpose of this study is to measure the effects of MDMA on sleep, mood, thinking, and how~     your body retains water. The researchers are interested in the effects that occur a few hours~     after taking MDMA as well as effects occurring over the next two days. We will study these~     effects in a standardized, controlled setting at the Clinical and Translational Science~     Institute (CTSI) Clinical Research Center (CRC) located at San Francisco General Hospital.~      The primary hypotheses are:~        1. MDMA will induce sleep disruption, as indicated by comprehensive polysomnography, wrist~          actigraphy, and self-report sleep measures~        2. MDMA will alter sodium and water homeostasis by either increasing or blunting the~          suppression of arginine vasopressin levels and decreasing free water excretion. Effects~          will be exacerbated by water loading.~      Secondary hypotheses:~        1. Acutely, MDMA will increase both positive and negative arousal, and to increase~          sociability but not autonomy.~        2. Acutely, MDMA will increase risk-taking and willingness to donate money to others in an~          economic decision making task.~        3. MDMA will decrease the stressful effects of talking about a negatively-valenced~          autobiographical but will increase recall for details for these episodes.~        4. MDMA will increase oxidative stress markers and possible ameliorating factors (e.g.,~          ADMA).~        5. The short form of the serotonin transported promoter region will be associated with~          greater acute and discontinuation effects of MDMA.~   "
191832|NCT01053390|"~     Objective Primary:~      Determine the objective response rate in patients with advanced gallbladder treated with new~     Chemotherapy regimen~      Secondary:~      Determine time to progression-free survival and overall survival of patients treated with~     this regimen.~      Determine quality of life of patients treated with this regimen. Determine the toxicity of~     new chemotherapy regimen~   "
191833|NCT01053377|"~     The incidence of severe morbidity and mortality following an influenza infection during the~     annual influenza epidemics is highest among the elderly population and 90% of~     influenzaassociated mortality occurs in this group. Vaccination is considered the best~     preventive intervention available but offers only partial protection. The protective effect~     decreases with advancing age and existing co-morbidity. Therefore, in spite of high~     compliance with vaccination, the risk of influenza-related complications among nursing-home~     residents, is particularly high, and consequently also the associated disease and economic~     burden. There is debate on the potential health benefit of the antiviral activity of~     oseltamivir as an effective supplementary intervention to prevent or contain influenza~     outbreaks in nursing homes. Although effectiveness of post-exposure prophylaxis (PEP) with~     oseltamivir on preventing transmission has been demonstrated in trials among healthy (mainly~     unvaccinated) adults and children, effectiveness has not yet been assessed among vulnerable~     vaccinated highrisk groups, such as the elderly population in nursing homes. If proven~     (cost)effective, oseltamivir could have considerable benefits in this setting, although~     constraints relating to implementation need to be addressed as well.~   "
191834|NCT01053364|"~     The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™~     Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal~     stenosis~   "
191835|NCT01053338|"~     To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine~     citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of~     Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fed~     conditions.~   "
191836|NCT01053325|"~     Malaria is a major contributor of disease burden in Sub-Saharan Africa: 90% of global cases~     occur there, and pregnant women and children under 5 years are the most vulnerable. Malaria~     in pregnancy increases risks of abortion, stillbirth, prematurity, intrauterine growth~     retardation and maternal anemia, and is associated with higher risk of low birth weight and~     perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy,~     the WHO recommends Intermittent Preventive Treatment (IPT) with antimalarial drugs,~     insecticide treated nets (ITNs) and effective treatment of malaria and anemia.~      HIV in pregnancy increases the risks of malaria, and it seems that the efficacy of IPT with~     the drug sulphadoxine-pyrimethamine (SP) is decreased in HIV+ pregnant women.~      Malaria prevention in pregnancy in Zambia relies on ITNs and IPT with SP. Daily prophylaxis~     with cotrimoxazole (CTX) effectively reduces mortality and morbidity in HIV+ individuals, and~     antibiotic therapy during pregnancy might help to decrease adverse pregnancy outcomes. CTX~     prophylaxis improves birth outcomes in HIV+ women with CD4<200/µl: a study concluded that~     antenatal provision of CTX was beneficial for HIV+ pregnant women with low CD4 but not in~     women with ≥200/µl (however, this study was carried out in an area with very low risk of~     malaria , and CTX may have a different effect depending on endemic conditions). The WHO~     recommends daily CTX in addition to ARVs, to prevent opportunistic infections in all HIV+~     patients.~      Concurrent administration of SP and CTX may increase the incidence of severe adverse~     reactions in HIV+ patients, so WHO has promoted CTX prophylaxis as an alternative to SP for~     the IPT in immuno-compromised pregnant women. Unfortunately, there is insufficient~     information on the effectiveness of daily CTX for preventing malaria infection in pregnancy:~     so, SP is still the only antimalarial recommended by WHO for this purpose. With the increase~     in SP resistance and with the newer antimalarials still being studied for safety and efficacy~     in pregnancy, CTX could be an alternative for SP in reducing malaria and malaria-related~     morbidity and mortality in pregnancy.~      This study will try to to see if in HIV- and HIV+ pregnant women, CTX is not inferior to SP~     in reducing placental parasitaemia. Such information is needed to issue updated, effective~     guidelines on malaria prevention in pregnancy~   "
191837|NCT01053312|"~     This study will determine the level of association between the quantitative estimates of~     brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of~     amyloid levels in biopsy samples previously obtained during shunt placement in patients who~     have normal pressure hydrocephalus (NPH).~   "
191838|NCT01053299|"~     All newborn from the period 12.1988 to 31.12.2006 During the two last decades, hip ultrasound~     has gained acceptance as an accurate screening test for developmental dysplasia of the hip~     (DDH) and for monitoring the development and treatment of the condition. Debate continues~     over whether DDH that is detected by ultrasonography is necessarily clinically relevant. The~     diagnostic accuracy of ultrasound imaging for DDH in the screening population has not been~     investigated adequately. Studies that investigate the natural course of the disorder, the~     optimal treatment for DDH, and the best strategy for ultrasound screening are needed.~     Ultrasound screening at birth for DDH in all newborn infants is standard practice in some~     European countries but not in the United Kingdom, the United States, or Scandinavia. Evidence~     is insufficient to support or reject general ultrasound screening of newborns for DDH.~     (N.F.Woolacott etc 2006, systematic review BMJ) At Vestre Viken HF, Kongsberg, Norway, the~     investigators implemented universal ultrasound screening in 1998. We will present the long~     term outcome, including radiographs of the hips after 5-12 years.~   "
191839|NCT01053286|"~     This is a research study to learn more about whether capsaicin, a natural ingredient of chili~     peppers that makes them taste hot, can improve swallowing function. The purpose of this~     study is to evaluate whether sucking on a capsaicin lozenge improves sensation in the throat~     enough to improve swallowing function.~   "
191841|NCT01053260|"~     Rates of overweight and obesity are increasing, particularly among individuals aged 18 to 29.~     An estimated 25-35% of American college and university students are overweight or obese.~     Contingency Management (CM) is a behavioral intervention that provides tangible rewards for~     positive behaviors. CM has substantial evidence of efficacy in reducing smoking and drug use~     and increasing treatment retention and medication compliance. The current study will evaluate~     the efficacy of a 24-week CM intervention to promote weight loss in overweight and obese~     university students. Seventy participants with a body mass index (BMI) of 27.0-34.9 will be~     randomly assigned to one of two conditions: (a) LEARN, a manual guided behavioral weight loss~     program (Brownell, 2004), with weigh-ins and supportive counseling, or (b) LEARN with~     weigh-ins and supportive counseling plus CM. Participants in the CM condition will earn~     chances to win prizes each week in which they lose at least one pound. Once they lose 5% of~     baseline body weight, they will earn chances to win prizes for weight loss or weight~     maintenance. Additional chances can be earned by completing activities that promote weight~     loss. The primary outcomes will be absolute and proportional weight loss from pre- to~     post-treatment, as well as proportion of participants achieving clinically significant weight~     loss (>5% of baseline weight) and proportion moving into a lower risk BMI category. Secondary~     outcomes will include length of retention in the study, increase in physical activity level,~     and improvement in nutritional quality of diet. Effects of the CM intervention on psychiatric~     distress and self-efficacy and motivation to engage in activities that promote weight loss~     will also be assessed. We predict that participants in the CM condition will lose more weight~     than participants assigned to the LEARN program without CM, and that more CM participants~     will achieve clinically significant weight loss. We also predict that participants in the CM~     condition will remain in the program longer, show larger increases in physical activity, show~     greater improvements in diet quality, and have greater increases in levels of self-efficacy~     and motivation than comparison group participants. Mediators and moderators of CM outcomes~     will also be evaluated. If efficacious in promoting weight loss in a college population, CM~     could help to prevent or delay later development of obesity-related medical problems.~   "
191842|NCT01053247|"~     The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic~     Dermatitis.~      Treatment medication will be administered as follows: Apply a thin layer of ointment to~     affected skin areas twice daily and rub in gently and completely. Study medication will be~     applied twice a day, approximately 12 hours apart, for approximately 2 weeks.~   "
191843|NCT01053234|"~     The purpose of this study in patients with type 2 diabetes was to investigate the acute~     effect of postprandial blood glucose levels modified by two different insulin treatment~     regimens on coagulation activation, inflammation and endothelial cell function. The~     investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial~     postprandial effect on coagulation, endothelial dysfunction and inflammation compared with~     the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.~   "
191844|NCT01053221|"~     This randomized trial will enroll adult recipients of HLA-identical living kidney transplants~     who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or~     cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to~     either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The~     hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal~     allograft function in the absence of long-term calcineurin inhibitors in this fully matched~     renal transplant cohort.~   "
191845|NCT01053208|"~     To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine~     citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil® PM, of~     Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fasting~     conditions.~   "
191846|NCT01053195|"~     Qingdao Diabetes Prevention Project aims to translate the trial experience to communities~     with specific objectives to:~        -  raise the public awareness of diabetes and diabetes risk factors~        -  promote healthy lifestyle of the entire targeting population~        -  reduce the number of people with obesity~        -  reduce the number of high-risk people developing diabetes through lifestyle intervention~        -  prevent the diabetic complications~        -  evaluate the effect and the cost of the community-based prevention project. The project~          is community-based targeting at the entire population of 1.94 million living in four~          administration districts of the city of Qingdao in China. In the first phase of the~          project (2005-2008) the work emphasis is on health promotion, training over 2000 primary~          care professionals and 300 school health nurses and establishing a network consisting of~          600 community clinics. In the second phase (2008-2012) lifestyle counseling sessions~          will be provided to about 242112 high-risk individuals identified, and the efficacy and~          the cost of the project will be evaluated at the end of the project in 2012.~   "
191847|NCT01053182|"~     Worldwide, esophageal cancer is the 6th most common cause of cancer-related death. Currently~     curative resection remains the cornerstone of the therapy. Despite advances in anesthesia,~     operative techniques and postoperative management, postoperative pulmonary complications~     (PPCs) occur frequently accounting for about 30% of all postoperative complications. Most~     importantly, PPCs have much been associated with postoperative mortality. The diaphragm is~     the most important respiratory muscle and its respiratory function would be inevitably~     damaged when esophagectomy is performed through the left posterolateral thoracotomy (Sweet~     procedure) because the diaphragm must be dissected for the purpose of stomach moralization.~     Meanwhile, Ivor-Lewis approach may effectively avoid diaphragm injury because the stomach can~     be managed through a laparotomy whereas an additional abdomen incision is needed. Both~     procedures are routinely used in practice when surgically managing esophageal cancer. The~     investigators hypothesize that Ivor-Lewis procedure might be superior to the left-thoracotomy~     route during esophagectomy in preventing PPCs.~   "
191848|NCT01053169|"~     Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the~     coagulation factors II, VII, IX and X which are important for blood clotting (coagulation).~     Lack of any of these factors means that blood does not clot as quickly as it should and so~     there is an increased tendency to bleed. This observational study was designed to evaluate~     the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding~     during surgery (perioperative bleeding) in a routine clinical setting.~   "
191849|NCT01053156|"~     This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of~     age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a~     controlled trial of minocycline, an antibiotic commonly used in children for infection or for~     treatment of neurodegenerative disorders. We are investigating its use in FXS because it~     lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also~     strengthens brain connections in the animal models of FXS. We hypothesize that minocycline~     will likely be helpful for language, behavior and/or cognition in fragile X patients.~   "
191903|NCT01052454|"~     This is a study to determine if participation in a mindfulness-based stress reduction program~     is feasible for women experiencing five or more hot flashes/day, and whether it affects~     either the frequency and/or intensity of their hot flashes, or the degree of bother they~     experience from them~   "
191851|NCT01053130|"~     Weight loss surgery is the most effective weight loss treatment available, but the direct~     effect on chronic kidney disease is less widely understood. Early research shows some~     improvement in kidney function may occur and candidacy for kidney transplantation can be~     improved with weight loss following surgery. To date, no randomised controlled trial has been~     performed to examine the effect of weight loss surgery on the progression of chronic kidney~     disease.~      This randomised trial will allocate patients to either lifestyle modification with diet,~     exercise and pharmacotherapy, or weight loss surgery to remove two thirds of the stomach~     using the laparoscopic sleeve gastrectomy procedure. This study aims to evaluate weight loss~     surgery vs lifestyle modification in patients with chronic kidney disease with estimated~     kidney function of 20-60% and morbid obesity (BMI 35-45) in terms of kidney function,~     cardiovascular disease risk factors and all-cause mortality.~   "
191852|NCT01053117|"~     To determine if a protocolized approach to converting hemodialysis central venous catheters~     (CVC) to arteriovenous fistulae will improve rates of functioning AVF and decrease CVC use.~   "
191853|NCT01053104|"~     To develop a system to manage side effects and adjust chemotherapy dose such that a patient~     can receive their personal maximum tolerated dose.~   "
191854|NCT01053091|"~     The purpose of this study is to investigate how exercise-base rehabilitation influences~     circulatory functions in patients with diastolic heart failure (DHF).~   "
191855|NCT01053078|"~     Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly~     and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is~     left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe~     hypoglycemia can lead to seizures, coma, and even death.~      Some people with diabetes do not have early warning signs of low blood sugar. This condition~     is called hypoglycemia unawareness. It happens when the body stops reacting to low blood~     sugar levels and the person does not realize that they need to treat their hypoglycemia. This~     can lead to more severe and dangerous hypoglycemia.~      The purpose of this early study is to see if a drug called naltrexone should be studied more~     in people with Type I diabetes and hypoglycemia unawareness. This study will show whether~     naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic~     resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the~     brain when a person is experiencing hypoglycemia.~   "
191856|NCT01053065|"~     The impact on cardiovascular events achieved by statin therapy seems to be mostly~     attributable to the cholesterol-lowering effect with a highly debated contribution of the~     lipid-independent pleiotropic effects. However, a short-term benefit has been documented for~     patients treated with statins in acute coronary syndromes and other clinical settings. These~     observations strengthened the hypothesis of additional, so-called pleiotropic actions of~     statins.~      The investigators therefore sought to investigate how different lipid-lowering strategies~     (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of~     carotid plaque over a short-term period of three months. Specifically the investigators tried~     and dissect the LDL-C lowering impact on plaque cellular composition as compared to the~     lipid-independent contribution on plaque macrophage and smooth muscle cells.~   "
191857|NCT01053052|"~     Multi-center prospective comparison of fallopian tubal patency determination and uterine~     evaluation interventions using legally marketed devices for their intended purposes, and~     using each subject as their own control.~   "
191858|NCT01053039|"~     The primary aim of this study is to assess the impact of intrathecal morphine on~     post-operative pain following instrumented fusion for degenerative lumbar spine disease.~     Secondary objectives of this study aim to assess side effects, overall narcotic use and~     duration of hospital stay following administration of intrathecal morphine.~      Based on our literature review, we expect a significant improvement in pain scores and~     functional status and minimal side effects with the use of intrathecal morphine. With~     improved pain and function we would also expect shorter hospital stays in those patients~     receiving intrathecal morphine.~   "
191859|NCT01053026|"~     The aims of this clinical trial are to assess the impacts on vascular function tests and~     circulating biomarkers of a short-term (12-week) low-to-median intensity exercise training or~     ARBs treatment in patients with DM and hypertension.~   "
191860|NCT01053013|"~     This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for~     patients with pancreatic cancer (all stages) and advanced colorectal cancer that no longer~     responds to standard therapies.~      The treatment is being evaluated for its effect on tumor growth. It consists of the placement~     (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA~     macrobeads). The cells in the macrobeads produce substances that have been shown to slow or~     stop the growth of tumors in experimental animals and veterinary patients. It has been tested~     in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II~     studies in patients with colorectal, pancreatic or prostate cancers are in progress.~   "
191861|NCT01053000|"~     To determine and compare the safety and efficacy of broad area photodynamic therapy with~     aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with~     occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with~     an incubation time of 60 minutes, using blue light.~   "
191862|NCT01052987|"~     This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period~     2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate~     the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to~     evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum~     uric acid levels.~   "
191904|NCT01052441|"~     The purpose of the study is to evaluate diagnostic performance of high iodine (iopamidol 370~     mg/dl) content versus low iodine (iodixanol 300 mg/dl) content for diagnostic accuracy by~     contrast-enhanced Coronary Cardiac Computed Tomography (CCTA) using a 64-detector-row CT~     scanner for detection of presence or absence of coronary artery obstruction when compared~     against invasive coronary angiography, the standard of truth.~   "
192050|NCT01050517|"~     This randomised, controlled, double blinded clinical study investigates the safety and~     efficacy of the combination of albendazole, ivermectin and praziquantel in the treatment of~     children aged 5-18 years co-infected with lymphatic filariasis, schistosomiasis and~     soil-transmitted helminthiasis.~   "
191863|NCT01052974|"~     Therapeutic essay of phase IV, monocentric, prospective, randomized, in double-blind during~     48 hours(then simple-blind),controlled by placebo.~      Abstract:~      The increasing incidence of the number of femoral neck fractures and the poor prognosis of~     this traumatological pathology involves an optimization of the diagnostic, therapeutic and~     analgesic care.~      A widespread collectively practice for the analgesia in prehospital or preoperative period is~     the single injection (single shot) of local anesthetic with the technique of the femoral or~     iliofascial block. Nevertheless the single injection of a dose of local anesthetic associated~     or not with analgesic adjuvants, due to their pharmacological properties, can't prolong the~     efficiency of the loco-regional analgesia more than 12 hours.~      The aim of our study is to evaluate, in the patients admitted in emergencies for suspicion of~     femoral neck fractures, the perioperative efficiency of an analgesic treatment using a~     femoral perineural catheter (inserted from the hospital admission) with continuous infusion~     of ropivacaïne controlled by placebo (physiological serum).~   "
191864|NCT01052961|"~     Adult patients hospitalized with influenza have higher viral loads and more severe illnesses.~     Thus more aggressive treatment approaches (e.g. higher dose oseltamivir) have been suggested~     to treat patients suffering from severe influenza infection.~      The investigators plan to investigate the impact of higher-dose oseltamivir (150 mg b.d.)~     treatment on viral clearance and clinical recovery in adult patients hospitalized for severe~     influenza. Such information may lead to optimization of the management strategy used for~     these patients.~   "
191865|NCT01052948|"~     To assess the association between cabergoline and other dopamine agonists (DAs), and~     symptomatic, diagnosed serious cardiopulmonary disorders, including:~        1. Cardiac valve regurgitation~        2. Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis~        3. Heart failure~        4. Total, cardiac and respiratory mortality~   "
191866|NCT01052935|"~     This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal~     vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody~     levels.~   "
191867|NCT01052922|"~     Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for~     screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual~     screening rates by use of time-to-event analyses (also known as survival analysis). The~     outcome variable of interest is the first time since randomization to have CRCS, either based~     on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons~     between groups, but also over time.~      Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study~     aims. First, we will enroll patients age 50-74 years using the same criteria as for the~     primary SOS study, which includes neither history of colorectal cancer nor evidence of~     life-limiting disease. Participants who return the questionnaire, consent and considered~     eligible will be randomized to receive one of three different at-home fecal test kits. The~     kits will be returned to the GH centralized laboratory, and participants will be informed~     about lab results using standard GH pathways. Participants who have a test-positive will~     receive a series of two follow-up surveys (first at 1-2 weeks post result and second at~     4-months post result). A comparison group of test-negative results will be matched based on~     selected criteria, and this group will also receive the follow-up surveys. Participants at~     both time intervals who do not return the survey via mail will be called and if available,~     administered the questionnaire via phone.~   "
191868|NCT01052909|"~     The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of~     Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis~     Pharmaceuticals Inc in healthy subjects, under fasting condition.~   "
191869|NCT01052896|"~     The purpose of this study is to evaluate the effectiveness of gabapentin on symptom control~     in patients with defined functional dyspepsia refractory to conventional proton pump~     inhibitor therapy and to compare these effects to that of placebo.~   "
191870|NCT01052883|"~     The purpose of this study is to compare the drug levels of darunavir obtained after~     administration of a single administration of the 800 mg tablet (new formulation) to that~     following administration of two 400 mg commercial tablets formulation when administered under~     fed and fasted conditions to those also taking low-dose ritonavir. Darunavir is marketed for~     the treatment of HIV. The short-term safety and tolerability of darunavir following~     administration of a single 800 mg dose of darunavir given to healthy volunteers taking taking~     low-dose ritonavir will also be assessed.~   "
191871|NCT01052870|"~     Previous studies of finasteride treatment in women with hair loss have failed to show~     positive results, yet, some women have responded anecdotally. Given that polymorphisms of the~     androgen receptor gene which confer androgen sensitivity impact male response to finasteride~     therapy, it was hypothesized that the same polymorphism in women may identify the group that~     will respond. This study is designed to test the impact of finasteride therapy on hair loss~     in postmenopausal women.~   "
191872|NCT01052857|"~     The purpose of this study is to evaluate the efficacy and safety of acupuncture for the~     induction of labor in pregnant women at the 40 weeks + 4 days of gestation.~   "
191873|NCT01052844|"~     Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic~     surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy~     induced emesis.~      The purpose of this study is to determine whether the addition of gabapentin to dexamethasone~     plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.~   "
191874|NCT01052831|"~     This study will evaluate the effectiveness of naltrexone in reducing ICD symptoms in~     Parkinson's disease patients taking a dopamine agonist.~   "
191875|NCT01052818|"~     The purpose of the study is to evaluate the association between the number of circulating~     tumor cells and response to treatment in non small-cell lung cancer patients~   "
191876|NCT01052805|"~     1. To explore the pathology of nerve, vasculature in the normal control nerve~        2. Compare the pathology of control nerve and nerve from amputated limb of diabetes~   "
191877|NCT01052792|"~     An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover,~     comparative bioequivalence study.~   "
191878|NCT01052779|"~     The purpose of the study is to evaluate the safety and efficacy of intravenous (IV)~     ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in~     participants with chronic kidney disease (CKD).~   "
191879|NCT01052766|"~     In this particular study the physicians want to use a new technique of how they obtain the~     PET/CT pictures. It is called breath-hold (BH) PET/CT. As the name suggests, they will ask~     the patient to hold their breath for about 20-30 seconds, and only during that time will they~     obtain pictures. This is repeated several times. In contrast to the standard PET/CT scan,~     they expect less blurring of the pictures, so that they can see the tumor better and~     measure the uptake of radioactive sugar in the tumor better and more reliably. Basically,~     this is the difference between taking pictures of a runner as compared to taking pictures of~     a person standing still. Since PET images need to be obtained over several minutes and people~     can not hold their breath for this extended time, we break the procedure into several cycles~     of 20-30 seconds (or longer, if possible) and then add all the frozen pictures in the end~     into one. They want to know if BH PET/CT scan measure changes in the cancer during therapy~     (i.e., from the baseline scan before therapy to the follow up scan at within 4 weeks later).~   "
191880|NCT01052753|"~     The ultimate goal of this study is to find specific polymorphism of candidate genes~     (particularly of dopaminergic and noradrenergic systems) associated with intermediate~     phenotypes (e.g., executive functions, IQ, and other neuropsychological function) and/or~     phenomenological phenotypes (subtypes, comorbidity, dimensional approach) of ADHD. We propose~     to replicate the analysis of the candidate genes identified by previous genetic studies and~     recent findings from GWAS on ADHD using the candidate gene association study design~     (family-based case control study using parental controls and population-based case-control~     study). These results may lead our research team: (1) to resolve controversies over~     inconsistent findings in previous genetic studies and contribute to the literature on the~     validity of ADHD and its subtypes using clinical and genetic data; (2) to identify potential~     endophenotypes for ADHD genetic studies; and (3) to identify specific polymorphism of~     candidate genes and gene expressions of dopaminergic and noradrenergic systems associated~     with executive functions measured by the CANTAB.~   "
191881|NCT01052740|"~     Background:~        -  X-ray mammography is the standard method for breast cancer screening. It is a~          noninvasive test using x-rays to take pictures of breast tissue and detect any~          abnormalities.~        -  The National Institutes of Health (NIH) Clinical Center has a breast imaging unit that~          has been accredited by the American College of Radiology. To maintain accreditation, the~          unit must recruit a certain number of women to have clinical mammograms each year in~          order to maintain a high level of clinical skills and experience for the radiologists~          and technologists.~      Objectives:~      - To create a state-of-the-art mammography unit at the NIH Clinical Center in order to~     maintain American College of Radiology accreditation of the NIH breast imaging facility.~      Eligibility:~      - Women who are eligible for breast cancer screening because of family cancer history,~     genetic test results, or previous instances of cancer. Participants may not be pregnant or~     nursing at the time of the screening.~      Design:~        -  Participants will provide a brief medical history on arrival at the NIH breast imaging~          unit.~        -  Each participant will have a standard mammogram performed by a radiology technician.~        -  If the study is normal, participants will be told that no further evaluation will be~          performed. If the results indicate a need for further imaging or tissue biopsy,~          participants may elect to return to the care of their primary physician or to receive~          further follow-up at the NIH Clinical Center.~   "
191882|NCT01052727|"~     DOLCE Study: Day-care versus Overnight-stay Laparoscopic Cholecystectomy randomized,~     controlled trial.~      The aim of this study was to evaluate the feasibility, safety and patient acceptance of~     outpatient LC in Italy. In particular this randomized clinical trial will use the SF-36 as~     powerful instrument to compare quality of life and global health status after LC performed as~     a day-care procedure or with an overnight stay.~      Particular attention is taken to answer to the following methodological issues:~        -  concealed randomization,~        -  ITT analysis,~        -  number of eligible, excluded and refusing patients clearly stated.~   "
191883|NCT01052714|"~     This program aims to help Veterans who take antipsychotic medications lose weight. We use a~     program based on the American Diabetes Association's Diabetes Prevention Program, and we~     have modified it to fit the lifestyles of people with mental illness. All participants are~     educated about nutrition and cutting down fat intake, how and when to exercise, and the~     causes of diabetes and how to prevent it. Participants must be Veterans who live within one~     hour of the Long Beach, West Los Angeles, Sepulveda, or West Los Angeles VA hospitals.~   "
191884|NCT01052701|"~     This research is being done to find out whether abacavir (Ziagen®) lowers the levels of~     ribavirin (Ribapak®) in the body of persons taking these two drugs.~   "
191885|NCT01052688|"~     To collect samples for the purpose of developing and optimizing an in vitro noninvasive~     prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA~     extracted from whole blood samples collected from women who are pregnant with a fetus~     previously determined to have a chromosomal abnormality. The NIPD result will be compared to~     the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR,~     and/or any commercially available NIPD test.~   "
191886|NCT01052675|"~     In France, the Afssaps is the body in charge of the evaluation of pharmacodependance. In~     order to fulfil its mission, the Afssaps has created a network of 11 Centres for Evaluation~     and Information on Pharmacodependance (CEIP), coordinated by the Drugs and Psychotropics~     Unit. Pharmacodependence notifications issued by professionals are collected by each Centre~     which evaluates them. Nantes' CEIP created an original tool to harmonize case reporting and~     make it possible to homogeneously evaluate the seriousness of pharmacodependence cases as~     each CEIP had his own way of analysing his cases. The aim of this study is to assess this~     tool.~   "
191887|NCT01052662|"~     The purpose of this study is to examine the effect of memantine and buprenorphine on opioid~     abusing behavior, to determine the effect of memantine and buprenorphine on early relapse and~     to evaluate the tolerability of memantine co-administrated with buprenorphine. The study~     seeks to determine if combined treatment of memantine and buprenorphine may provide~     shorter-term treatment for opioid dependence.~   "
191888|NCT01052649|"~     Study on healthy volunteers is focusing on analysis of transcriptome profile fluctuations in~     healthy population in three mononuclear cell types (CD4+ cells, CD56+ cells and CD4+CD25+~     cells)and should provide a reference for comparison with transcriptomic data of any disease~     state.Furthermore, metabolome and immunological status are defined on same samples.~   "
191889|NCT01052636|"~     Specific Aims~      The long-term objective of this study is to examine the effectiveness of an intervention~     program for older patients with hip fracture. First, an intervention program for elderly~     patients with hip fracture will be developed and implemented, then, the effectiveness of the~     intervention program will be examined. The specific aims are as follows:~        1. To develop a well conceived and feasible protocol of hospital discharge and sub-acute~          care that involves the coordinated work of health care professionals (physicians,~          surgeons, nurses, and physical therapists) and the informal caregivers. The feasibility~          of implementing such a protocol within the context of an intervention study subject to~          the constraints of the clinical setting (i.e., CGMH) will be evaluated in a pilot study.~        2. To conduct a randomized clinical trial to evaluate the outcomes and costs associated~          with the proposed hospital discharge/sub-acute care protocol for elderly patients with~          hip fracture. Both experimental and case study methods will be used. Information on~          outcome indicators including clinical outcomes, quality of life, self-care ability,~          family caregiving outcomes, patient and caregiver satisfaction, and services utilization~          will be collected and compared between the control group and the experimental group.~        3. To conduct a validation clinical trial to verify the results of the primary randomized~          clinical trial and increase the generalization of the study findings.~        4. To estimate the cost of this care model and its variations for individual patients.~   "
191890|NCT01052623|"~     This study will evaluate the status of the growth hormone/ insulin-like growth factor-1~     (GH/IGF-1) axis in relation to growth failure, body weight and composition and~     neuroprotection in children with Ataxia telangiectasia (AT).~   "
191891|NCT01052610|"~     The purpose of the trial is to asses the efficacy and safety of sublingual annual~     immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house~     dust mites.~   "
191892|NCT01052597|"~     There are evidence that there is an association between insulin resistance and prolonged~     hyperinsulinemia or hyperglycemia in Type 2 diabetic patients. This will trigger oxidative~     stress system via reactive oxygen species (ROS) and lead to a high level of Nitric oxide.~     This can contribute to a significant change in blood vessel and could end up with the~     complications from cardiovascular disease and increased mortality rate of type 2 diabetic~     patients. The purpose of the present study was to examine the effectiveness of the curcumin~     in type 2 diabetic patients on the reduction of atherosclerosis events by examining~     pulse-wave velocity (PWV) and plasma high-sensitivity C-reactive protein (CRP) test and on~     blood sugar lowering, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance.~   "
191893|NCT01052584|"~     In this stdy, patients aged above 6 months with symptomatic malaria presenting to health~     centers will be enrolled for treatment with artemether-lumefantrine for P. falciparum~     infection, and either artemether-lumefantrine or chloroquine for P. vivax infection.~     Clinical, parasitologic, and hematologic parameters will be monitored for P. falciparum and~     P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug~     efficacy. Results from this research study will be used to assist Ethiopia in assessing their~     current national malaria drug policies.~   "
191894|NCT01052571|"~     To evaluate differences in outcomes in patients receiving steroids compared to those patients~     randomized to the local anesthetic group who did not receive steroids.~      To evaluate and compare the adverse event profile in all patients.~   "
191895|NCT01052558|"~     The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular~     micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle~     glaucoma or ocular hypertension and co-existing cataract.~   "
191896|NCT01052545|"~     Overtreatment of asymptomatic bacteriuria (ABU) is a quality, safety, and cost issue,~     particularly as unnecessary antibiotics lead to emergence of resistant pathogens. Our~     proposal to bring clinical practice in line with published guidelines has significant~     potential to reduce unnecessary antibiotic use for ABU in the VA healthcare system, thus~     improving the quality and safety of veterans' healthcare. Our study will also provide~     important insights about how to implement and sustain evidence-based clinical practice within~     VA hospitals.~   "
191897|NCT01052532|"~     The investigators hypothesize that MR in humans is characterized by adrenergic overdrive,~     reactive nitrogen species, and an antifibrotic phenotype that relate to the severity of~     adverse LV remodeling prior to surgery and outcome after valve repair.~   "
191898|NCT01052519|"~     The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese~     patients (BMI> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy~     during laparoscopic surgery.~      Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation~     (PsqO2)is increased in obese patients when fluid management is optimized by means of~     esophageal Doppler monitoring compared to obese patients undergoing standard fluid~     management.~      Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese~     patients undergoing conventional fluid therapy compared to non-obese patients when fluid~     management is optimized. Thus the investigators assume that PsqO2 is similar in obese and~     non-obese patients when fluid management is optimized in both groups.~   "
191899|NCT01052506|"~     The primary objective of the study is to evaluate the safety and tolerability of single dose~     of BIIB033 administered to healthy adult volunteers.~   "
191900|NCT01052493|"~     When humans eat, the bowels naturally secrete chemicals into the bloodstream which make~     people feel full and which stop eating. One of these chemicals is known as Pancreatic~     Polypeptide (PP). We have previously shown that injections of human PP reduces appetite and~     food intake. We have now developed a very similar chemical, PP 1420, as a treatment for~     obesity. PP 1420 has been tested in animals and has been shown to be safe, and to reduce~     their appetite. This study will test PP 1420 for its safety and tolerability in humans.~   "
191901|NCT01052480|"~     This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and~     pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B.~     Hospitalized subjects with influenza A or B that have either a low oxygen level or a high~     respiratory rate will be eligible for study participation. This study will enroll adults,~     children and pregnant women.~   "
191902|NCT01052467|"~     This non-interventional, prospective, non-controlled study of Xamiol® Gel, a fixed~     combination of calcipotriol and betamethason dipropionate, shall investigate in daily routine~     the efficacy, tolerability and changes in quality-of-life parameters in patients with scalp~     psoriasis~   "
191905|NCT01052428|"~     The investigators hypothesize that beta-1 receptor blockade (ß1-RB) attenuates extracellular~     matrix (ECM) degradation and progressive adverse Left Ventricular (LV) remodeling and failure~     in the volume overload of mitral regurgitation (MR). Patients without coronary artery disease~     and moderate MR, as assessed by color/flow Doppler echocardiography, will be randomized to~     ß1-RB vs. placebo to address the following aims:~      *Aim 1: Establish whether ß1-RB attenuates adverse LV remodeling compared to placebo in~     patients with non-surgical, chronic MR. Using 3-dimensional magnetic resonance imaging (MRI)~     and tissue tagging, LV function and geometry will be assessed at baseline and every 6 months~     for up to 2 years.~      Aim 2: Determine whether indices of inflammation correlate with degree of LV remodeling and~     whether ß1-RB decrease indices of inflammation and collagen turnover. At the time of MRI,~     blood samples for collagen breakdown products, matrix metalloproteinase (MMP) activity, and~     markers of excess production of reactive inflammatory species (RIS) will be obtained and~     related to changes in LV remodeling defined by serial 3-dimensional MRI and tissue tagging.~   "
191906|NCT01052415|"~     In this project, UCLA's Center for Community Health (CCH) will develop an efficacious~     intervention trial integrating both individual and structural components to reduce HIV-~     related stigma among service providers in China and therefore benefit people living with~     HIV/AIDS (PLWHA).~      The purpose of this study is to develop a feasible, practical and low cost intervention~     strategy that will prevent and/or reduce the negative effects of HIV-related stigma among~     health service providers in China.~      This project will be conducted in two provinces and proceed in two phases. In Phase 1,~     confidential focus groups will take place with small samples of service providers and~     hospital administrators to finalize the intervention activities, and the investigators will~     also test and finalize the Audio Computer-Assisted Self-Interview (ACASI) assessment measures~     and implementation procedures with the same group of service providers. During Phase 1 a~     small sample of patients will anonymously test the paper-pencil baseline survey. Equal number~     of samples will be selected from two counties of each province. The findings from Phase 1~     will be used to develop intervention, and revise assessment for Phase 2.~   "
191907|NCT01052402|"~     The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune~     response, immunogenicity of two different doses, antibody persistence 360 days after the~     first vaccination, immune response to a heterologous booster given on Day 360) of a Vero~     cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents~     aged 6 months to 17 years.~   "
191908|NCT01052389|"~     The GiSAS study is a multi-centre randomized clinical trial that will involve about 80~     italian community psychiatric services in Italy and will recruit 800 patients affected by~     schizophrenia.~      In a sample of schizophrenic outpatients, it is hypothesized that there are significant~     differences in the overall tolerability and effectiveness of aripiprazole, olanzapine and~     haloperidol at 12 months.~      It is a pragmatic trial. Thus, participants are selected to represent a broad range of~     real-world patients, all treatment medications are non-blinded and after randomization, the~     assigned drugs will be prescribed according to usual care practice.~      The measure for effectiveness is retention of patients on the assigned treatment. The measure~     for tolerability is the onset of metabolic syndrome.~   "
191909|NCT01052376|"~     The principle objective of this study is to validate confocal endomicroscopy (CEM) in a~     national, multicenter study, in terms of its ability to diagnose neoplastic lesions in vivo,~     in two groups of patients at high risk of colorectal cancer (CRC): patients with familial~     adenomatous polyposis (FAP) after colectomy in whom the neoplastic lesions are probably~     under-diagnosed, and patients with inflammatory bowel diseases (IBD) in whom endoscopic~     surveillance is particularly difficult. Methods: The study will be comprised of two phases~     (Phase I and II). Phase I will serve to validate at the multicenter level the results of the~     first, recently published, monocenter German study in terms of capacity of CEM to identify~     the colonic neoplastic lesions in vivo. Phase II is destined to prospectively evaluate the~     diagnostic yield of CEM in detection and prediction of neoplastic lesions by developing and~     adding new features to the confocal pattern of in vivo diagnosis. Two cohorts of patients~     will be studied in parallel: Patients with inflammatory bowel diseases (IBD), like ulcerative~     colitis (UC) or Crohn's disease (CD), including those before planned colectomy, and patients~     with FAP after colectomy. During lower endoscopy performed under general anaesthesia, each~     colonic segment will be examined before and after staining with indigo-carmin. After~     intra-venous fluorescein injection, all macroscopically abnormal lesions will be examined by~     CEM, then biopsied. In parallel, multiple random biopsies will be performed, each coupled~     with simultaneous CEM optical biopsy at the same point. In addition, during Phase II, in~     IBD patients before planned colectomy and in patients with FAP, a mapping of colonic~     mucosa, by obtaining a very high number of CEM optical biopsies, will be performed, and~     will be correlated with standard histology performed either on colectomy specimens (IBD) or~     on standard biopsies (FAP). Principal analysis (Phase I and II) will include evaluation of~     inter-observer variation in terms of interpretation of in vivo histology and diagnostic yield~     of CEM with respect to the detection of neoplastic lesions by evaluation of sensitivity and~     specificity, using standard histology as reference method. Additional analysis (Phase II)~     will be performed to evaluate the diagnostic and predictive (CRC risk) value of colonic~     mapping by correlating optical images pattern score to results of standard histology.~     Expected results: This study should guarantee high quality data, standardization of~     procedures and of interpretation of CEM images, which are prerequisite for dissemination of~     CEM in clinical practice. The investigators expect to show that CME allows to reliably~     discriminate between neoplastic and non-neoplastic lesions, that, compared to standard~     histology, provides better characterization of lesions, especially in the context of extended~     lesions like in IBD, an finally, that CME images can be used to develop a new optical~     biopsy-based score allowing prediction of high CRC risk in patients with FAP and IBD. The~     investigators believe that CEM may increase, as compared to currently used techniques, the~     diagnostic yield in terms of probability of the detection of neoplastic lesions in patients~     at high risk of CCR, and may become a new standard for endoscopic surveillance in these~     patients.~   "
191910|NCT01052363|"~     Pilot Trial of CA4P with Avastin in Recurrent Gliomas~   "
191911|NCT01052350|"~     The purpose of this study is to use a brain imaging method called PIB PET to determine~     dementia subtypes in patients with Parkinson's disease. The ultimate goal of this project is~     to be able to identify individuals with PD who are at risk of developing dementia, and to~     distinguish the underlying cause of dementia.~   "
191912|NCT01052337|"~     Aim of this trial is to compare propofol-based anaesthesia vs. sevoflurane-based anaesthesia~     induction in patients with cervical myelopathy receiving oral or nasal fiberoptic intubation.~   "
191913|NCT01052324|"~     Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive~     function. It can be used for conscious sedation during awake nasotracheal fiberoptic~     intubation. Target-controlled infusion is more reliable technique for maintaining optimal~     infusion rate than manual controlled infusion. The aim of this study is to determine the~     effect site concentration of remifentanil for successful conscious sedation during awake~     nasotracheal fiberoptic intubation.~   "
191940|NCT01051973|"~     The study aims to compare two manualized treatments. They are based on cognitive behavior~     therapy or stress management. Both treatments are delivered via an internet application and~     the patients' work with the treatments is supported through online contact with a therapist.~     The treatments last for 10 weeks.~      Approximately 200 patients will be included in the study and randomized to either condition.~      The study hypothesis is that CBT will be superior to stress management on the main outcome~     measure, which is IBS symptom severity measured over 4 weeks.~   "
191914|NCT01052311|"~     Laropiprant (LRP; Merck & Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily,~     highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of~     extended-release niacin and 20 mg of laropiprant (ERN/LRPT) offers improved tolerability,~     supporting a simplified 1-2 g dosing paradigm and improved adherence. Statins and niacin~     improve endothelial function in cardiac patients, however, there is no data yet regarding the~     additive effects of raising HDL-C by ERN/LRPT and statins on endothelial function in cardiac~     patients. Thus the aim of the present study is to evaluate the impact of 3 months'~     administration of ERN/LRPT compared to placebo added to statins on endothelial function,~     assessed by brachial artery vasoreactivity in stable cardiac patients.~   "
191915|NCT01052298|"~     Objectives of the study are to investigate the safety, tolerability and levels of~     ciprofloxacin in the lung after single and multiple inhalative administration to patients~     with mild to moderate COPD (stage I-II according to GOLD Criteria).~   "
191916|NCT01052285|"~     The purpose of this study is to determine whether Transversus abdominis plane block is~     superior to placebo or superior to local infiltration in analgesic efficacy after groin~     hernia repair.~   "
191917|NCT01052272|"~     The investigators hypothesize that in patients with diabetes and acute myocardial infarction~     (MI), Ang II type-1 receptor blockade (AT1RB) attenuates left ventricle (LV) remodeling to a~     greater extent than angiotensin converting enzyme (ACE) inhibitor therapy and that the~     addition of xanthine oxidase (XO) inhibitor, Allopurinol, results in further improvement in~     LV remodeling and function in the follow-up phase after MI.~   "
191918|NCT01052259|"~     The purpose of this study to examine the efficacy and safety of cycling treatment of~     deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection.~   "
191919|NCT01052246|"~     The results of pulsed dye laser (PDL) treatment of acne vulgaris published so far are~     controversial: Whereas Seaton et al. described a marked improvement of mild-to-moderate acne~     after low-fluence pulsed-dye laser therapy, Orringer et al. were unable to replicate said~     results in a similar, albeit not identical, study design. More recently published studies~     failed to resolve the controversy, varying in terms of treatment procedure(s) as well as~     results.~      While published results are certainly promising enough to be followed up by independent~     research, they are insufficient to justify the abdication of methods with proven efficacy.~     Considering patient treatment ethics and the short 'window of opportunity' for scar~     prevention when active inflammatory lesions are present, the investigators planned the~     adjuvant application of the PDL in the present study, providing all patients with the well~     established and evidentially effective modality of a fixed-combination clindamycin 1%-benzoyl~     peroxide 5% hydrating gel (C/BPO). The goal of the study was the assessment of the efficacy~     and safety of a low-fluence PDL treatment in addition to C/BPO in patients with facial~     inflammatory acne.~   "
191920|NCT01052233|"~     It has been previously demonstrated that the risk for the development of knee osteoarthritis~     is increased after both meniscus tear and meniscectomy. However, it is still unclear whether~     this is due to the meniscus tear per se, the surgery, or whether the development of knee~     osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to~     investigate the effect of arthroscopic partial meniscectomy on the development of knee~     osteoarthritis 2 to 10 years after the procedure.~   "
191921|NCT01052220|"~     The major purpose of this quantitative study is to determine if a 3 month supportive~     educative nursing intervention incorporating Blood Pressure (BP) education and BP, salt and~     fluid monitoring, in addition to goal setting and reinforcement will improve BP control in a~     chronic end-stage renal disease population.~   "
191922|NCT01052207|"~     Role fo oxidative stress in adrenal insufficiency has not been studied. The degree of~     oxidative stress and it's role in pediatric critical illness is unknown. Potential for~     significant alterations to many of thew body's regulatory pathways may result from severe~     oxidative stress. Further is needed to delineate what if any role oxidative stress may play~   "
191923|NCT01052194|"~     This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3~     inhibitor, for treatment of subjects with active RA. This study will assess the clinical~     response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients~     with active RA. The study will also evaluate the safety and tolerability of VX-509 compared~     to placebo when administered for 12 weeks to subjects with active RA.~   "
191924|NCT01052181|"~     Type 2 diabetes is a major public health problem in India with an estimated a prevalence of~     approximately 4% and 12% in rural and urban areas respectively. Accumulating evidence~     suggests that serum cholecalciferol levels may be inversely related to the prevalence of~     diabetes, insulin resistance and metabolic syndrome. The trials available on the effect of~     Vitamin D supplementation on insulin/glucose metabolism have been conducted using small~     sample sizes in different subgroups document variable results (significant decrease in HbA1c~     concentration with insulin concentration in hemodialysis patients; insulin levels lower with~     oral Vitamin D in gestational diabetes; no effect of Vitamin D on serum insulin levels in~     post menopausal women). A double blind randomized controlled trial conducted at our institute~     using 3,60,000 IU of cholecalciferol over 6 weeks documented improvement in OGIS index of~     insulin sensitivity. We therefore, plan to study the long term effect of vitamin D~     supplementation on peripheral insulin sensitivity.~   "
191941|NCT01051960|"~     The purpose of this study is to determine the clinical characteristics and hemodynamic~     profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic~     sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects~     with exercise induced Pulmonary Arterial Hypertension (PAH) with scleroderma~   "
191942|NCT01051947|"~     A randomized, cross-over, single-blind study to compare the effects of nebivolol and~     metoprolol on central aortic pressure and peripheral brachial pressure in patients with~     stable cardiovascular disease.~   "
192048|NCT01050543|"~     This is a randomized, active-controlled, parallel-group, single-dose, multi-site,~     safety-assessor blinded study comparing sugammadex to neostigmine for reversal of~     neuromuscular blockade in Korean subjects undergoing elective surgical procedures under~     general anesthesia that require rocuronium for neuromuscular blockade. Study medication will~     be administered at reappearance of T2. Time to recovery will be measured from start of study~     medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is~     that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with~     neostigmine.~   "
191925|NCT01052168|"~     Emphasizing the growing popularity of motion metrics are the majority of available virtual~     reality simulators and some newer hybrid models that offer motion tracking for performance~     assessment. A popular hybrid model (PROMIS) allows training with regular laparoscopic~     instruments in a box-trainer while automatically recording task duration and movement~     efficiency (pathlength and smoothness) that are immediately offered as feedback to trainees.~      Despite the increasing availability of simulators that track motion, our knowledge of the~     impact those metrics have on trainee learning is severely limited. We do not know if it is~     more important to use speed, accuracy, motion efficiency or a combination thereof for~     performance assessment and how these metrics impact skill transfer to the OR.~      Based on sound educational principles we have developed a proficiency-based laparoscopic~     suturing simulator curriculum. This curriculum focuses on deliberate and distributed~     practice, provides trainees with augmented feedback and sets expert-derived performance goals~     based on time and errors. We have previously demonstrated that this curriculum leads to~     improved operative performance of trainees compared to controls.~      To measure operative performance and determine transferability, we will use a live porcine~     Nissen fundoplication model. Instead of placing actual patients at risk, the porcine model is~     preferable for this purpose as it offers objective metrics (targets are established,~     distances measured, knots are disrupted for slippage scoring), complete standardization, and~     allows multiple individuals to be tested on the same day.~      We hypothesize that proficiency-based simulator training in laparoscopic suturing to~     expert-derived levels of speed and motion will result in better operative performance~     compared to participants training to levels of speed or motion alone. The study is powered to~     detect an at least 10% performance difference between the groups.~      Specific Aims~        1. Compare whether any performance differences between the groups persist long-term~        2. Assess whether the groups demonstrate differences in safety in the operating room by~          comparing the inadvertent injuries in the animal OR between the groups~        3. Identify the training duration required by novices to reach proficiency in laparoscopic~          suturing based on speed, motion efficiency, or a combination of these metrics~        4. Identify any baseline participant characteristics that may predict individual~          metric-specific performance~   "
191926|NCT01052155|"~     Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain~     Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass~     Spectometry (LC/MS/MS)~   "
191927|NCT01052142|"~     The purpose of this study is to determine whether Lipovaxin-MM, a new anti-cancer vaccine, is~     safe and effective in improving the body's ability to destroy cancer cells in patients with~     metastatic melanoma.~   "
191928|NCT01052129|"~     An open label randomised, two-treatment, two-period, two-sequence, single-dose, crossover,~     comparative bioequivalence study.~   "
191929|NCT01052116|"~     The trial is designed to study the effects of soy supplements on asthma control.~   "
191930|NCT01052103|"~     The purpose of this study is to determine whether LY2140023, when added to standard-of-care~     antipsychotic treatment, will improve negative symptoms.~   "
191931|NCT01052090|"~     To evaluate the safety, tolerability and efficacy of escalating dose of PHN121 when~     administered orally in non-responder hepatitis C genotype 1 patients~   "
191932|NCT01052077|"~     This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will~     receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive~     substance) in addition to an FDA approved antidepressant in order to determine if the study~     medication is effective as an add on treatment of MDD.~   "
191933|NCT01052064|"~     Low frequency repetitive Transcranial Magnetic Stimulation(rTMS) is a safe and tolerable~     procedure in children with Attention Deficit Hyperactivity Disorder(ADHD); it also could be a~     complement to the treatment of patients with poor symptomatic control to conventional~     treatment.~   "
191934|NCT01052051|"~     To determine the effect of increasing serum 25(OH)D from prevailing levels with vitamin D3~     supplementation, while maintaining adequate calcium intake, on incidence of all-type cancer~     in a population sample of healthy postmenopausal women.~   "
191935|NCT01052038|"~     Sore throat is a common postoperative complaint that can lead to morbidity and patient~     dissatisfaction . The incidence of sore throat has been reported to be between 6% and 90%~     even under optimal intubating conditions. There are several factors that have been shown to~     contribute to postoperative sore throat such as patient related factors, type of anesthesia~     and type of surgery.~      Corticosteroids are also commonly used in the perioperative period to potentiate analgesics~     and as antiemetics. The preoperative administration of dexamethasone can decrease the~     incidence and severity of postoperative sore throat which is rated by patients as one of the~     most undesirable outcomes in the postoperative period.~   "
191936|NCT01052025|"~     The incidence rate of type 2 diabetes in Thai populations is high and increasing every year.~     Cardiovascular disease is the main complication of this disease, which has been defined as an~     important cause of death among Diabetic patients. This disease is now becoming a major health~     problem and causes a great economic loss to the country. Evidence shows that Curcumin, Thai~     herbal medicine, has the effectiveness of prevention and delay of type 2 diabetes. However,~     there is no scientific study that aims to prove the efficacy of this herb particularly for~     prevention and delay the disease in Patients with impaired glucose tolerance (pre-diabetes)~     and insulin resistance.~   "
191937|NCT01052012|"~     This is a research study testing SABER™-Bupivacaine (an experimental pain-relieving~     medication). SABER™-Bupivacaine is designed to continuously deliver bupivacaine, a common~     local anesthetic, for a few days in order to treat local post-surgical pain.~      The purpose of this study is to investigate safety (side effects) associated with the use of~     SABER™-Bupivacaine and how well it works in reducing pain and opioid-related side effects~     following various kinds of abdominal surgeries.~   "
191938|NCT01051999|"~     Patients with cystic fibrosis develop frequent and potentially life-threatening lung~     infections. Recent studies suggest that the nutrient glutamine may help the body fight off~     infection. Glutamine is an amino acid; a type of nutrient the body requires to build muscle.~     It is one of the building blocks of protein. During an illness, blood levels of glutamine~     tend to be lower than normal. Also, many patients with cystic fibrosis have difficulty~     getting normal levels of nutrients from food. The aim of this study is to see if patients~     with cystic fibrosis have low levels of glutamine when they experience an infection, and~     whether a dietary glutamine supplement taken daily for three months can raise these levels.~     We also want to see if this supplement can improve other blood markers of immunity (the~     body's ability to defend itself from infection). We hope to enroll 40 people with cystic~     fibrosis who experience a lung infection, over a one year period, into this study.~   "
191939|NCT01051986|"~     The purpose of this study is to compare early and 1-year graft patency rates of saphenous~     vein composite grafts with those of right internal thoracic artery composite graft and~     mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass~     grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no~     touch technique and used as composite graft.~   "
191943|NCT01051934|"~     Background:~        -  Advanced cases of non-small-cell lung carcinoma (NSCLC) usually are not successfully~          treated with standard therapies. Even treatments that attempt to specifically target~          NSCLC cells have not proved effective.~        -  Researchers are interested in determining whether a combination of the chemotherapy~          drugs SS1 (dsFv) PE38, paclitaxel, carboplatin, and bevacizumab may be effective in~          shrinking the size of NSCLC tumors. Three of the drugs (paclitaxel, carboplatin, and~          bevacizumab) are commercially available, while the other is a drug that is currently~          being tested to determine its usefulness in cancer treatment. This study will help to~          determine if the combination of all four drugs is more effective and as safe, safer, or~          less safe than other drug combinations given to treat NSCLC.~      Objectives:~      - To determine a safe and tolerable dose for the combination of SS1 (dsFv) PE38 with~     paclitaxel, carboplatin, and bevacizumab in patients with advanced mesothelin-expressing lung~     adenocarcinoma.~      Eligibility:~        -  Age > 18 years of age~        -  Newly diagnosed advanced non-small-cell lung carcinoma~        -  No prior chemotherapy for lung cancer~        -  Individuals at least 18 years of age who have advanced non-small-cell lung carcinoma~          that has not responded to standard treatments.~      Design:~        -  The study will last for two 21-day cycles of treatment for the four-drug combination,~          with additional treatment cycles of carboplatin, paclitaxel, and bevacizumab.~        -  Two to three weeks prior to the study, participants will be screened with a full medical~          history and physical exam, bone marrow biopsy (we do not do bone marrow biopsies) (if~          one has not been performed in the last 6 months), computed tomography (CT) or ultrasound~          scan, tumor measurements, and other tests as required by the researchers. Participants~          will provide blood and urine samples at this time as well.~        -  During the study, participants will receive SS1 (dsFv) PE38, carboplatin, paclitaxel,~          and bevacizumab for a maximum of two cycles. On Day 15 of the first cycle, participants~          will provide a blood sample to be tested to see if SS1 (dsFv) PE38 is being effective.~          If the tests show that SS1 (dsFv) PE38 is not effective, participants will not receive~          another dose of it, but will continue to receive paclitaxel, carboplatin, and~          bevacizumab for the second cycle.~        -  After the first two cycles, participants will continue to receive carboplatin,~          paclitaxel, and bevacizumab every 3 weeks for up t...~   "
191944|NCT01051921|"~     The purpose of this study is to determine if the combination treatment of CTS-1027, pegylated~     interferon and ribavirin can improve the response rates in HCV patients who did not~     previously respond to pegylated interferon and ribavirin therapy.~   "
191945|NCT01051895|"~     This trial will compare HPV testing to the routine colposcopy in the follow-up of women~     treated for cervical high grade lesions. Women will be assigned randomly (by chance) after~     treatment of cervical pre-cancer to be either (1) followed-up by colposcopy, or (2) undergo~     HPV testing. Women found to have disease by either strategy will be offered re-treatment. For~     the next 2 years participants will undergo yearly, in depth, evaluation to assess the cervix~     for precancer. We will then be able to compare which of the 2 follow-up strategies worked~     best.~   "
191946|NCT01051882|"~     The study will evaluate the safety, tolerability and therapeutic effects (preliminary~     efficacy) of injection of autologous cultured mesenchymal bone marrow stromal cells secreting~     neurotrophic factors (MSC-NTF), as a possible treatment for patients with Amyotrophic Lateral~     Sclerosis (ALS) at the early and progressive disease stages.~   "
191947|NCT01051869|"~     Both simple decompression and anterior transposition of the elbow nerve (ulnar nerve) for~     acute displaced fractures of the elbow (distal humerus) treated with plate fixation are~     currently used by surgeons. We want to examine which treatment will overall give better~     results in regards to arm function and residual pain.~   "
191948|NCT01051856|"~     The purpose of this research study is to find a lowest leak rate following a distal~     pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to~     have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the~     pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and~     prevent leaks at the end of the pancreas.~   "
191949|NCT01051843|"~     The purpose of this study is to identify the orofacial difficulties during the maternal~     breastfeeding in rooming-in.~   "
191950|NCT01051830|"~     The purpose of this study is to 1) develop a well-conceived and feasible protocol for~     hospital discharge and subacute care for hip-fractured elderly persons with DM, and 2)~     compare the costs and effectiveness of this DM-specific model with those of an effective~     subacute care model previously developed by our research team.~   "
191951|NCT01051817|"~     A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of~     multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI~     scans over a 24 week period in patients with relapsing-remitting multiple sclerosis~   "
191952|NCT01051804|"~     Comparison of two contact lens solutions.~   "
191953|NCT01051791|"~     To carry out exploratory studies to determine if activity of this regimen correlates with~     tumor and patient associated markers of the EGF-R/mTOR pathway These markers may correlate~     with activity of this regimen and provide exploratory insights in to the mechanism of this~     treatment approach.~      Expression of the pathway components including EGF-R and phosphorylated EGF-R (p-EGF-R), ERK~     and p-ERK, Akt and p-Akt(T308 and S473), p70s6k and p-p70s6k, S6 and p-S6, HIF-1-alpha, p27~     and 4E-BP1 will be assessed. Mutation and FISH analysis for EGF-R expression will also be~     performed on tumor samples. Biopsies will be obtained at the following times: pre-treatment,~     and after 4 weeks (one cycle) of treatment. If available, original diagnostic tissue may be~     submitted in place of the pre-treatment biopsy.~   "
191954|NCT01051778|"~     The aim of this study is to compare the efficacy and safety of Low molecular weight heparin~     (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with~     recurrent pregnancy loss associated with antiphospholipid syndrome (APS).~   "
191955|NCT01051765|"~     Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be~     effective and safe in western studies. Different with westerns, squamous carcinoma is the~     main pathological type in china patients. The investigators then initiated a prospective~     phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced~     esophageal carcinoma to observe the efficacy and safety of the combination.~   "
191956|NCT01051752|"~     A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are~     evaluated in a cohort of patients with NTM diseases.~   "
191957|NCT01051739|"~     Improved Assessment of Visual Field Change is a trial aimed at investigating mechanisms of~     visual field testing variability. The investigators have found using larger stimulus size~     substantially lowers short-term variability. In this study, the investigators will determine~     if larger stimuli detect visual field change at an earlier time. The investigators are also~     developing a statistical model that accounts for correlations of neighboring test locations.~   "
192009|NCT01051050|"~     The goal of this study is to improve surgical residents' skills in critically appraising the~     literature and to promote the dissemination and application of the best available evidence to~     surgical practice. The hypothesis is that mandatory participation, with faculty oversight, in~     a journal club wiki will improve the dissemination, evaluation, and application of~     evidence-based medicine (EBM) in a surgical residency program at University of Texas Health~     Science Center at Houston (UT-Houston).~   "
191958|NCT01051726|"~     Aromatherapy is a form of complementary medicine that uses scented materials known as~     essential oils for the purpose of affecting a person's health or mood. Although aromatherapy~     has been used in childbirth for centuries, there are no high-quality studies examining~     whether the treatment works.~      Methodology~      We would like to see if aromatherapy affects a woman's experience of childbirth by lowering~     associated anxiety and pain. Consenting participants will be randomly allocated to one of~     these groups:~        1. Aromatherapy oils (e.g. clary sage, peppermint, lavender, frankincense)~        2. Non-essential oil (baby oil)~        3. Standard maternity care~      We will gather primary data, e.g. if she's been in labour before and her awareness of~     complementary medicine. We will also conduct the Spielberger State-Trait Anxiety Inventory~     with her, and provide her with the oil and swab if she is in groups 1 or 2 with instructions~     to keep the swab with the oil on it near to her. She can also put more oil on the swab as she~     requires.~      Postnatally, data will be collected from her notes regarding pain relief used, duration of~     labour, augmentation of labour, and any other medical interventions of note. We will also~     complete the anxiety scale with her once more. Before her discharge we ask the mother for any~     comments regarding her experience of the labour. The results from all three cohorts will then~     be compared. There will also be opportunity for the midwife to make any comments regarding~     his/her perception of the participant's labour. Finally we will hold a focus group with~     midwives regarding the practicalities for implementation of aromatherapy in maternity care~   "
191959|NCT01051713|"~     The ENGAGED study is a 12-month randomized controlled trial investigating different~     strategies to improve weight loss in overweight individuals. All participants will receive an~     effective weight loss treatment: either self-guided or group formats. All treatment will be~     provided in the Department of Preventive Medicine at Northwestern University. Participants~     who receive the self-guided weight loss treatment will be provided with a weight loss manual~     that contains proven behavioral weight loss strategies. Those participants who receive the~     group treatment will take part in 8 weekly, 90 minute group sessions in our clinic at 680 N.~     Lakeshore Dr., Chicago, IL 60048. Some participants will also be assigned an individual~     coach, who will communicate with them regularly via phone, email, and/or text message for the~     duration of the study. All participants must be willing and able to record food and beverage~     intake (either on a smartphone or on paper) and be willing to wear a small and unobtrusive~     physical activity measurement device for the first six-months of the study. Additionally, all~     participants will be asked to attend 3 follow-up assessment visits at our clinic at months 3,~     6 and 12 after the study begins. Participants will be compensated for completing each of the~     3 follow-up assessments. All participants will be part of a team weight loss competition at 3~     and 6 months with financial incentive to be split evenly among the winning team.~   "
191960|NCT01051700|"~     This study is to evaluate the safety, absorption rate and side effects associated with the~     study drug. Healthy volunteers will be given a single dose of the drug in Part 1. Subjects~     will be dosed at the same time at several different sites. In Part 2 of the study elderly~     volunteers will participate in a 14 day repeat dose session receiving either study drug or a~     placebo (sugar pill). Data from at least 7 days of safety will be reviewed from the first set~     of volunteers before increasing the doses for the next set. All results will be used for~     planning the next study.~   "
191961|NCT01051687|"~     Background: New light shed on the cholinergic aspects of vitiligo pathophysiology. It was~     found that acetylcholine concentration increased with a significantly reduced expression of~     acetylcholinesterase in vitiliginous patches that return to normal up on repigmentation.~      Objective: The investigators will undertook this controlled, prospective pilot study to~     evaluate the efficacy and safety of botulinum toxin A in patients with localized vitiligo.~      Methods: 10 patients with focal or segmental vitiligo will be recruited. For each patient~     with focal vitiligo, one or two vitiliginous patches will be treated. The other patches will~     be used as control. For each patient with segmental vitiligo, half of the lesion will be~     treated. The other half will be used as a control. Botulinum toxin will be injected. The~     response will be analyzed at the initial visit, two weeks and at two and six months after~     therapy.~   "
191962|NCT01051674|"~     Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may~     not have type 2 diabetes will be randomized to one of two conditions (70 in each condition):~     (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to~     follow their assigned diets for 1 year. Outcome measures of interest will include~     participants' BMI, waist circumference, blood lipids (total, HDL, and LDL cholesterol, and~     triglycerides), C-reactive protein, and gastrointestinal peptides. Participants will be~     recruited from the Loma Linda and San Bernardino city area in southern California.~   "
191963|NCT01051661|"~     The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1~     flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years~     of age.~   "
191964|NCT01051648|"~     Injecting Triamcinolone acetenoide for visualizing and removing vitreous from the anterior~     chamber.~   "
191965|NCT01051635|"~     Background:~        -  Indenoisoquinolines are experimental cancer treatment drugs that damage the DNA in~          cells, resulting in cell death. Researchers have been studying these drugs and their~          usefulness in treating types of cancer that have not responded well to standard~          therapies like surgery or radiation.~        -  LMP400 (NSC 743400) and LMP776 (NSC 725776) are indenoisoquinolines that have not been~          given to cancer patients before. These drugs have very similar chemical structures and~          work the same way, but researchers do not know which one will work best. More~          information is needed about how LMP400 and LMP776 are processed by the body and how~          effective they are in treating difficult-to-treat types of cancer.~      Objectives:~        -  To determine the maximum tolerated dose of LMP400 (NSC 743400) and LMP776 (NSC 725776).~        -  To study how the body handles LMP400 and LMP776.~        -  To evaluate the effectiveness of LMP400 and LMP776 as a treatment for tumors and~          lymphoma that have not responded to standard treatment.~      Eligibility:~      - Individuals at least 18 years of age who have malignant solid tumors or Hodgkin s~     disease/non-Hodgkin lymphoma that has not responded to standard therapies.~      Design:~        -  Participants will receive either LMP400 or LMP776. The treatment cycle will be 28 days.~          On the first 5 days of each cycle, participants will receive intravenous doses of their~          specific study drug, followed by 23 days without the drug. The 28-day cycle will be~          repeated as long as the drug does not cause severe side effects and the cancer remains~          stable or improves. The study doctor may increase or decrease the dose of study drug~          depending on how well it is tolerated.~        -  Blood, urine, and hair samples and skin and tumor biopsies will be collected during the~          first treatment cycle. Routine blood samples will be taken throughout the study.~        -  Other tests, including additional blood and urine samples, computed tomography (CT) or~          other scans, and bone marrow samples, may be performed as directed by the study doctors.~   "
192010|NCT01051037|"~     The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and~     radiofrequency ablation is safe for patients with lung tumors near central airways.~   "
191966|NCT01051622|"~     Using scintigraphic imaging including planar scintigraphy and SPECT, this study will evaluate~     the utility of two different ex vivo 99mTc-HMPAO labelled mononuclear cell populations in~     order to select the optimal methodology (using PBMC or purified lymphocyte subpopulations)~     for future drug intervention studies in Crohn's disease.~      Two parallel exploratory approaches will be investigated to enrich for lymphocyte populations~     expressing leukocyte trafficking inhibitors. In the first, whole blood will be fractionated~     on a ficoll gradient to purify a heterogeneous population of all the peripheral blood~     mononuclear cells (PBMC) for labelling. Secondly, further enrichment will be attempted using~     depletion of PBMC fractions of monocytes and B cells.~   "
191967|NCT01051609|"~     The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment~     serological markers of inflammation and assess for correlation with AI-MS.~   "
191968|NCT01051596|"~     People with colorectal cancer that cannot be cured by surgery are being asked to participate~     in this study.~      The purpose of this study is to test the efficacy (effectiveness) of a new combination of~     drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by~     damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells.~     ABT-888 inhibits an enzyme called PARP which helps to fix damaged DNA. By inhibiting this~     enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide,~     and will hopefully increase the killing of cancer cells, and decrease the tumors in the body.~      ABT-888 is an investigational or experimental anti-cancer agent that has not yet been~     approved by the Food and Drug Administration (FDA) for use in colorectal cancer.~      This study will help find out what effects (good and bad) the combination of drugs,~     temozolomide and ABT-888 has on colorectal cancer.~      This research is being done because it is not known if ABT-888 will increase the~     effectiveness of temozolomide for colorectal cancer.~   "
191969|NCT01051583|"~     Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the~     treatment of Neovascular Glaucoma.~   "
191970|NCT01051570|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and prednisone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving carboplatin together~     with everolimus and prednisone may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving carboplatin together with everolimus~     and prednisone works in treating patients with metastatic prostate cancer that progressed~     after docetaxel.~   "
191971|NCT01051557|"~     This phase I/II trial studies the side effects and best dose of temsirolimus when given~     together with perifosine and to see how well it works in treating patients with recurrent or~     progressive malignant glioma. Temsirolimus may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as perifosine,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving temsirolimus with perifosine may be an effective~     treatment for malignant glioma.~   "
191972|NCT01051544|"~     This is a prospective, controlled, randomized, open label study, aimed at comparing FVIII/VWF~     concentrates with FVIII concentrates at 200 IU/kg daily in their ability to induce immune~     tolerance in Haemophilia A patients with high responding inhibitors and poor prognosis for~     success.~   "
191973|NCT01051531|"~     The purpose of the study is to evaluate the safety, tolerability and treatment response of~     paliperidone palmitate administered as once-monthly injections to patients with~     schizophrenia.~   "
191974|NCT01051518|"~     The investigation concerns a prospective, multicenter, single arm safety and performance~     study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with~     symptomatic aortic native valve stenosis necessitating valve replacement which are considered~     poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and~     the cardiologist are recruited in the study.~      Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve~     performance and placement will be followed up at 3 and 6 months post-procedure. Further~     long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months~     post-procedure.~   "
191975|NCT01051505|"~     The purpose of this study is to explore the safety and tolerability of AZD5069 at~     steady-state, following twice a day oral dosing in healthy subjects.~      AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of~     the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second~     time that AZD5069 will be administered to humans in clinical trials. We are conducting this~     study to determine whether AZD5069 is safe and well tolerated by healthy males and females at~     different dose levels over an 8-day dosing period. We will also be studying how quickly~     AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3~     dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving~     the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8~     weeks, and will include 1 residential visit lasting 10 nights and a follow up.~   "
191976|NCT01051492|"~     Breast cancer is a common malignancy world-wide, and is the commonest female malignancy in~     Singapore, with rising trends in incidence over the last 2 decades. While there have been~     improvements in treatment, mortality from breast cancer remains significant. Development of~     biomarkers to predict treatment response and toxicity to anti-cancer agents can rationalize~     the choice of therapy for the individual patients to optimize treatment outcome and to reduce~     unnecessary toxicities. Development of novel therapies or novel approaches to therapy is also~     critical to improve the treatment armamentarium in breast cancer. These research strategies~     will have an significant impact on breast cancer treatment both in Singapore as well as~     globally.~   "
191977|NCT01051479|"~     The purpose of this study is to evaluate the investigators ability to obtain reliable and~     meaningful 11C-Choline PET-CT images of esophageal cancer.~   "
191978|NCT01051466|"~     Previous research studies have shown that depression is associated with changes in structure~     and activity in different parts of the brain and that antidepressant medication can affect~     brain activity in different parts of the brain in individuals suffering from depression. The~     primary purpose of the study is to find out more about how the antidepressant medication~     duloxetine affects brain activity and structure in individuals with depression.~   "
191979|NCT01051440|"~     There have been reports that stimulants may be effective for bipolar depression without~     triggering mania. This study will examine whether lisdexamfetamine can improve depressive~     symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is~     currently approved for attention deficit hyperactivity disorder (ADHD). Participants take the~     study drug or placebo in addition to a mood stabilizer. The study includes functional~     magnetic resonance imaging and magnetic resonance spectroscopy to determine whether the~     medication alters the response to affective stimuli or glutamate, glutamine, or gamma~     aminobutyric acid (GABA) levels. Neuropsychological testing is also included to determine~     whether the study drug improves memory and attention in this population. The primary~     hypothesis is that lisdexamfetamine is clinically effective in this population. The secondary~     hypothesis is that it will result in an increased response to affective stimuli and altered~     neurotransmitter levels in the anterior cingulate cortex.~   "
191980|NCT01051427|"~     This is a blind trial to test if Surgiflo is effective in posterior epistaxis. After the~     investigators see than anterior tamponade is not effective stopping epistaxis, the~     investigators try using Surgiflo and if it does not work the investigators continue with a~     nasal catheter. This is the usual way to stop nasal bleeding, but is painful and has serious~     after-effects in the nose. Surgiflo is a hemostatic matrix that can be put into the nose,~     painlessly and easily. So the investigators think it can be useful controlling nasal~     bleeding, so the investigators could avoid to put nasal catheters in these patients.~   "
191981|NCT01051414|"~     To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032~     for 24 weeks treatment.~   "
191982|NCT01051401|"~     This randomized pilot clinical trial studies rosuvastatin in treating women with~     cardiovascular complications who are undergoing chemotherapy for breast cancer. Rosuvastatin~     may prevent or lessen cardiovascular complications in patients undergoing chemotherapy for~     breast cancer~   "
191983|NCT01051388|"~     The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing~     to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal~     ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular~     protection.~   "
191984|NCT01051375|"~     The current application targets patient education and enablement, implementation of best~     practices, continuity of care, and an improvement model to improve efficiencies by~     investigating whether a brief targeted intervention prior to the first formal ED assessment~     is efficacious in altering outcome and treatment course.~   "
191985|NCT01051362|"~     This Phase II study is to explore the efficacy and toxicity of Pegylated liposomal~     doxorubicin and Carboplatin in patients with previously untreated non-small cell lung cancer~     (NSCLC) not amenable to radiotherapy or surgical treatment. The planned enrollment for this~     trial is 48 patients (including a 10% rate for inevaluable patients).~   "
191986|NCT01051349|"~     Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield~     Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple~     sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP~     and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS)~     relapse, slowing disability progression, and reducing new MS lesion formation in this study~     population.~   "
191987|NCT01051336|"~     The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the~     development program and to provide key safety and tolerability data for the Taris platform.~   "
191988|NCT01051323|"~     This observational study will investigate hemoglobin levels and Mircera (methoxy~     polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and~     compare standards of care between centers. Data from each patient will be collected over 12~     months of Mircera therapy.~   "
191989|NCT01051310|"~     The proposed investigation is a prospective, multicenter, non-randomized study to evaluate~     the immediate benefits (at discharge and at 30 days) in terms of performance and safety of~     the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis. In~     addition, the study aims to evaluate the performance and the safety of the implantation of~     the Medtronic CoreValve PAV in a failing aortic bioprosthesis at subsequent annual follow-ups~     out to 48 months post procedure.~      These objectives will be achieved through the following endpoints:~        -  Primary safety endpoint - Composite of Major Adverse Events~        -  Primary performance endpoint - Technical and procedural success at discharge~      Patient Population: Eligible subjects will be at least 75 years old, presenting with a~     failing aortic bioprosthesis (stenotic, incompetent or mixed) including homograft or stented~     or stentless heterograft, considered poor surgical candidates and necessitating repeat aortic~     valve replacement. Up to 20 patients will be included in up to four hospitals.~   "
191990|NCT01051297|"~     There is a clear link between obstructive sleep apnea (OSA) and cardiovascular disease.~     However, there has been no clear link between OSA and venous thromboembolism (VTE). The~     objective of this study is to evaluate such a link.~   "
191991|NCT01051284|"~     People with pancreatic cancer that cannot be cured by surgery are being asked to participate~     in this study.~      The purpose of this study is to test the ability of the radiation oncologists to administer~     Cyberknife therapy along with Gemcitabine chemotherapy for patients with pancreatic cancer.~     Radiation and Gemcitabine are both effective at killing cancer cells but they generally~     cannot be given at the same time. Cyberknife therapy is highly focused radiation that is~     being used extensively at Georgetown University and around the United States to treat a~     number of cancers. It is believed that because Cyberknife is so highly focused it can be~     given safely with regular doses of chemotherapy to attack cancer cells in two ways at the~     same time.~      This research is being done because it is not known if using Cyberknife with chemotherapy~     will be a safe way to treat pancreatic cancer.~   "
192011|NCT01051024|"~     The purpose of this study is to assess the efficacy of Diamel administration in the treatment~     of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3~     clinical trial will be 24 weeks.~   "
192049|NCT01050530|"~     OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to~     cirrhosis patients with ascites despite having received treatment with conventional diuretics~     and the change in body weight from baseline at the time of the final administration will be~     compared between the two groups.~   "
191992|NCT01051271|"~     ABSTRACT~      Study Objective:~      To compare the effects of midazolam and diphenhydramine for the prevention of metoclopramide~     induced akathisia.~      Methods:~      This randomized, double-blind and controlled trial aimed to investigate co-administered~     midazolam versus diphenhydramine in the prophylaxis of metoclopramide induced akathisia.~     Patients 18 through 65 years of age who presented to the ED with primary or secondary~     complaints of nausea and/or moderate to severe vascular type headache were eligible for this~     study. Patients were randomized to one of the fallowing three groups: (1) metoclopramide 10~     mg + midazolam 1.5 mg (2) metoclopramide 10 mg + diphenhydramine 20 mg (3) metoclopramide 10~     mg + placebo. Metoclopramide was administered as a 2 minutes bolus infusion. Midazolam,~     diphenhydramine and normal saline solution administered as a 15 minutes slow infusion. Whole~     procedure was observed, akathisia and sedation scores and vital changes were recorded.~   "
191993|NCT01051258|"~     The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in~     patients with advanced emphysema.~   "
191994|NCT01051245|"~     The purpose of this study is to determine whether case management for type 2 diabetic~     patients with target-organ damage improves quality of care compared to usual care.~   "
191995|NCT01051232|"~     A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy~     volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western~     population.~   "
191996|NCT01051219|"~     This is a randomized, controlled trial to determine whether Losartan is effective at slowing~     down, halting or reversing liver fibrosis in patients with non-alcoholic steatohepatitis~     (NASH). Liver fibrosis is the accumulation of tough, fibrous scar tissue in the liver which~     occurs in patients with NASH. NASH resembles alcoholic liver disease, but occurs in people~     who drink little or no alcohol. The major feature in NASH is fat in the liver, along with~     inflammation and damage, which may lead to cirrhosis, in which the liver is permanently~     damaged and scarred and no longer able to function properly.~      Primary hypothesis:~      That losartan is superior to placebo in reversing, slowing down or halting fibrosis in~     patients with non-alcoholic fatty liver disease, after 24 months of treatment.~      Secondary hypothesis:~        1. That the safety profile of the angiotensin receptor blocker (losartan) in this patient~          population is acceptable~        2. That losartan can prevent clinical deterioration in non-alcoholic fatty liver disease~        3. That serum, radiological and histological markers of fibrosis correlate in these~          patients over a 24 month period~   "
191997|NCT01051206|"~     HES 130/0.4 significantly solution will not affect on coagulation and blood loss in patients~     medicated with antiplatelet agents prior to off-pump coronary bypass surgery (OPCAB).~   "
191998|NCT01051193|"~     This study is designed to provide long term safety data of TRI476 in children with~     inadequately-controlled partial seizures. This study is conducted in patients who complete~     the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment~     phase of the extension study. All patients are treated with TRI476 from the dose adjustment~     phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.~   "
191999|NCT01051180|"~     Haemorrhoidal artery ligation operation (HALO) is an operation that ties off vessels to~     piles. This study examines whether the ultrasound (doppler) is necessary to guide this tying~     off or not.~   "
192000|NCT01051167|"~     Cetuximab is normally given as a weekly schedule in the therapy of patients with metastatic~     colorectal cancer.~      In order to improve the convenience for the patients in first line-therapy this study will~     evaluate the efficacy and safety of a bi-weekly combination of cetuximab with FOLFOX.~   "
192001|NCT01051154|"~     The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration~     during the first three months of treatment reduces the deterioration of nutritional status,~     treatment toxicity and early mortality in children with acute lymphoblastic leukemia.~   "
192002|NCT01051141|"~     The Emergency Department (ED) setting is a unique point of access for reaching underage~     drinkers (age 14-20). With the aid of computer technology, this study will screen underage~     drinkers in the ED and fully test promising ED-based brief intervention and 3-month follow-up~     brief treatment approaches for alcohol misuse. Developing methods to efficiently and~     effectively optimize these approaches has powerful public health implications for improving~     outcomes for underage drinkers.~   "
192003|NCT01051128|"~     The purpose of this clinical investigation is to demonstrate product performance of the~     Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the~     management of severe spasticity.~   "
192004|NCT01051115|"~     Patients with chemo refractory CLL have a poor prognosis. 2 independent mechanisms are~     attributed to the development of chemoresistance in CLL. The first is a shift in the balance~     between pro- and anti-apoptotic regulators. The second mechanism is based on acquired~     mutations resulting in a dysfunctional p53 response. Recent studies indicate that the~     tyrosine kinase inhibitor dasatinib acts synergistically with both purine analogies and~     alkylating agents. Also, dasatinib has the potency to restore the apoptotic balance of CLL~     cells.~      Hypothesis: Dasatinib will be clinically active in chemo-refractory CLL patients and will act~     synergistically with the purine-analogue fludarabine.~   "
192005|NCT01051102|"~     This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood~     sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese~     subjects with type 1 diabetes. Each subject will be randomised to one of the two possible~     treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic~     insulin aspart 30 followed by NN5401).~   "
192006|NCT01051089|"~     The study is a randomized controlled study comparing the metabolic effect of a 3 month~     intensive lifestyle modification intervention in Korean type 2 diabetic patients.~   "
192007|NCT01051076|"~     The purpose of this study is to evaluate whether a concentrate containing both FVIII and von~     Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who~     have already experienced and failed ITI with VWF-free FVIII concentrates. The treatment on~     this study is expected to last up to 33 months.~   "
192008|NCT01051063|"~     The purpose of this study is to evaluate the clinical activity and safety of a WT1~     Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-induction therapy in adult~     patients with WT1-positive AML presenting a suboptimal clinical response to induction~     chemotherapy. The study will also assess whether this treatment induces a specific immune~     response to the malignancy.~   "
192012|NCT01051011|"~     This randomized, open-label, parallel arm study will compare the safety, tolerability and~     effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients~     with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea~     combination therapy. Patients will be randomized to receive either taspoglutide 10mg~     subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc~     weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin~     treatment will be continued in all patients throughout the study, whereas sulfonylurea will~     be discontinued before starting study treatment. Anticipated time on study treatment is 24~     weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample~     size is 500-600 patients.~   "
192013|NCT01050998|"~     The primary objectives of this study is to assess the safety, tolerability and efficacy of~     multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with~     moderately active Rheumatoid Arthritis (RA).~   "
192014|NCT01050985|"~     This study is for people with advanced cancer for which no curative treatment exists.~      The purpose of this study is to test the safety and effectiveness of the combination of the~     drugs Temsirolimus and Capecitabine and see what effects it has on cancer.~      Temsirolimus is a drug that is given by vein that targets a protein important for the growth~     of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer~     cell growth and even lead to their death.~      Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in~     the body to the very common chemotherapy known as 5-fluorouracil.~      This research is being done because it is not known if the combination of Temsirolimus and~     Capecitabine will work better than Capecitabine or Temsirolimus alone.~   "
192015|NCT01050972|"~     This study is an interventional trial to evaluate the effectiveness of a cognitive and~     physical program (Intervention), in reducing the frequency of head and neck pain in the~     population of an extensive territory of Italy.~   "
192016|NCT01050959|"~     The purpose of this compassionate use study is to provide clinical and technical support of~     the Bion® microstimulator system to the subjects who have decided to keep the system for~     relief of headache symptoms that have not responded to medical treatment. These study~     subjects were enrolled and implanted with the Bion® system during a previous clinical~     investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.~   "
192017|NCT01050946|"~     This study is a means of providing transplantation to those patients who would be a stem cell~     transplant candidate who do not have an appropriate donor.~      The use of CD34 selected haploidentical donor with an umbilical cord unit may help provide~     earlier engraftment without the need for long term immunosuppression.~      This study tests a new method of bone marrow transplantation called combined~     haploidentical-cord blood transplantation. In this procedure, some of the blood forming cells~     (the stem cells) from a partially human leukocyte antigen (HLA) matched (haploidentical)~     related donor are collected from the blood, as well as cells from an umbilical cord are~     transplanted into the patient (the recipient) after administration of a conditioning~     regimen. A conditioning regimen consists of chemotherapy and sometimes radiation to the~     entire body (total body irradiation, or TBI), which is meant to destroy the cancer cells and~     suppress the recipient's immune system to allow the transplanted cells to take (grow).~   "
192018|NCT01050933|"~     Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care~     problem. It normally occurs in all patients after surgery to the abdomen but in some cases~     can result in serious complications. The objective of this study is to determine if inhaling~     very low doses of carbon monoxide (CO) before and after colon surgery will shorten the~     duration of normal POI and/or prevent the development of POI complications in patients~     undergoing colon surgery.~      This preliminary study will be conducted in ten healthy volunteers to monitor for blood~     levels and adverse effects that occur at different durations of exposure of inhaled CO to~     establish a safe dose for patients in the main trial. For the main trial, patients requiring~     surgery to their colon will be assigned randomly to receive one hour treatments of either CO~     or oxygen by face mask before and after their operation.~      We hypothesize that healthy volunteers will be able to tolerate 1 hour doses of 250 ppm of CO~     with minimal side effects. It is also anticipated that for each dose of CO administered, the~     blood levels of CO will remain well under poisonous levels. Finally, we anticipate blood~     levels of CO will return to baseline level within 24 hours following the last dose of CO.~   "
192019|NCT01050920|"~     Warfarin is a commonly used anti-coagulant, but has a narrow therapeutic index and wide~     inter-individual and inter-ethnic variation in dose requirements. Several genetic and~     non-genetic factors have been identified that could influence warfarin dose requirements.~     However, current known predictive factors could only explain about 50-60% of warfarin dose~     variability. Inter-ethnic differences in genetic influences on warfarin dose requirements~     also exist. We hypothesize that genetic factors other than CYP2C9 and VKORC1 may influence~     warfarin dosing and serve to further optimize warfarin dosing.~   "
192020|NCT01050907|"~     The purpose of this Treatment IND is to make miltefosine available for mucocutaneous~     leishmaniasis patients presenting in the United States.~      If entrance criteria are met, subjects with mucosal or cutaneous leishmaniasis will receive~     miltefosine at a targeted dose of 2.5 mg/kg/day for 28 days. During treatment at weeks 1, 2,~     and 4, the patient will return to the treatment facility to be assessed for adverse events.~     Blood for transaminase and creatinine values will be drawn at the midpoint and at the end of~     therapy.~      Patients will return to the treatment facility to be examined clinically at 6 wks (ie, 2 wks~     after the end of therapy), 3 months (2 months after therapy), and 7 months (6 months after~     treatment) for ML and CL patients, and also at 13 months (12 months after treatment) for ML~     patients.~   "
192021|NCT01050894|"~     This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated~     from patients with osteoarthritis.~   "
192046|NCT01050569|"~     The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine~     patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only~     and very low nicotine content cigarette only on abstinence, time to relapse and toxicant~     levels. The study will determine if adding nicotine replacement medication to the very low~     content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very~     low nicotine content cigarettes only.~   "
192022|NCT01050881|"~     Each year around 200 blood donors in the UK are found to be infected with blood-borne~     diseases (HIV, hepatitis B, hepatitis C, and HTLV), while several others have been identified~     as having an increased risk of variant Creutzfeldt-Jakob Disease (vCJD). Although the~     notification procedures for these infections vary, their effectiveness and appropriateness~     have never been evaluated in a systematic study.~      The proposed research has been designed to assess the responses of blood donors to~     notification and their satisfaction with how they were informed about the infection. The~     study will be implemented using standard questionnaire-based measures (French et al, 2004;~     Marteau & Bekker, 1992).~      The study will involve approximately 600 blood donors who were informed of an infection or~     possible infection with blood-borne diseases in 2008 and 2009, and approximately 100 donors~     notified of possible risk of vCJD infection in 2005. A comparable group of 2005 donors will~     be included to control for the effects of time. As the majority of donors testing positive~     donated to NHS Blood and Transplant (NHSBT), the participants will be identified from the~     NHSBT database only, and their availability confirmed through their GP or specialist~     clinician. A standardized questionnaire will be then sent to all those identified as~     eligible.~      The study will last 12 months, but direct participant involvement will be limited to the time~     required to complete the questionnaire, which should take under one hour. To safeguard~     confidentiality, no identifiable personal data will be used in the analysis. Where~     demographic or medical information already held by NHSBT is retrieved to minimise response~     burden, this will be pseudonymised before use.~      The study is sponsored by the blood services for England, Wales, Scotland and Northern~     Ireland. The results will be used to inform notification procedures in the future.~   "
192023|NCT01050868|"~     This prospective, non-randomized, non-controlled, interventional study will determine whether~     the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the~     competitor's ABC without causing significant hypoglycemia.~   "
192024|NCT01050855|"~     This is a Phase II pilot study to evaluate engraftment and toxicity of patients with~     non-malignant diseases using a reduced intensity conditioning regimen in the setting of~     allogeneic transplant for non malignant diseases. Bone Marrow or cord blood will be~     acceptable as a stem cell source.~      Recently, reduced intensity conditioning (RIC) regimens have been used for both adult~     patients with leukemias and pediatric patients with non-malignant diseases. These regimens~     are better tolerated, resulting in less transplant related morbidity and mortality. Stable~     mixed chimerism, while insufficient for eradication of leukemias, may be sufficient to cure~     patients with non-malignant diseases.~   "
192025|NCT01050842|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such~     as bicalutamide, may lessen the amount of androgens made by the body. Selective estrogen~     receptor modulators, such as raloxifene, may work together with bicalutamide to stop the~     growth of prostate cancer.~      PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating~     patients with metastatic or hormone-refractory prostate cancer.~   "
192026|NCT01050829|"~     The purpose of the study is to look at the safety (what are the side effects) and efficacy~     (how well does it work) of gadobutrol when used for taking MR images of the body/extremities~     regions. The results of the MRI with gadobutrol injection will be compared to the results of~     MR images taken without contrast and with the results of the MR images taken with Magnevist.~   "
192027|NCT01050816|"~     An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage~     defect patients who are appropriate for the trial, and evaluating the validity and safety for~     12 months.~   "
192028|NCT01050803|"~     To evaluate the effectiveness of the Farsi diabetes self-management education program on~     psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with~     type 2 diabetes and those with already-diagnosed type two diabetes who had received little~     self-management education. The development of the program was guided by an innovative process~     of intervention planning: Intervention Mapping.~   "
192029|NCT01050790|"~     RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer~     cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. An autologous stem cell transplant may be able to replace blood-forming cells that~     were destroyed by lenalidomide and azacitidine. Giving autologous lymphocytes after the~     transplant may help destroy any remaining cancer cells.~      PURPOSE: This pilot trial is studying how well giving lenalidomide together with azacitidine~     works when followed by autologous stem cell transplant and autologous lymphocyte infusion in~     treating patients with multiple myeloma.~   "
192030|NCT01050777|"~     Leishmaniasis with diverse clinical manifestations is caused by different species of~     Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a~     self-healing disease, but it takes a long time to heal. Pentavalent antimonials are still the~     first-line treatment of CL which needs multiple injections, are painful and as such not~     tolerated by most of the patients, in addition available treatments are not always effective~     and resistance is reported. Paromomycin sulfate (PM) reported to show anti-Leishmania~     activity against both CL and visceral leishmaniasis (VL) since 1960s. Therapeutic strategy~     with high efficacy is urgently needed especially for Anthroponotic Cutaneous Leishmaniasis~     (ACL). Liposomes are lipid bilayer molecules which entrap water-soluble molecules in their~     internal water compartment and water-insoluble ones into their lipid bilayers. Liposomes, in~     proper formulations and sizes, deliver drugs to the skin based on the similarity of the~     bilayers structure of lipid vesicles to that of natural membrane and target the macrophages~     within dermis. Several lipid-based formulations have been developed to treat experimental~     leishmaniasis. Recently different doses of liposomal formulation of PM and liposomal~     formulation of Glucantime were prepared and showed high efficacy in vivo against L. major~     infection in BALB/c mice.~      In this study the efficacy of liposomal formulation of PM or liposomal formulation of~     Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically~     proven patients will be evaluated. The clinical trial will be carried out according to the~     International approved GCP (Good Clinical Practice) guide lines.~   "
192031|NCT01050764|"~     Patients with hematologic malignancies will receive myeloablative chemotherapy followed by~     stem cell rescue with bone marrow or hematopoietic peripheral blood stem cells collected by~     apheresis from a filgrastim- (G-CSF)-mobilized haploidentical related-donor, ie,~     hematopoietic peripheral blood stem cell transplant (HSCT).~   "
192032|NCT01050751|"~     This is a randomized study to assess whether the pharmacokinetics of a new single 750 mg~     tablet is similar to 3 x 250 mg tablets (750 mg total).~   "
192047|NCT01050556|"~     The purpose of this study is to determine whether folic acid, alone or together with creatine~     supplementation, can lower blood arsenic concentrations and improve the ability to detoxify~     arsenic.~   "
192033|NCT01050738|"~     Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement~     of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new~     concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique~     implicates that a catheter is left in the surgical area and that local anestesia can be~     administered post surgery. The goal is no or only little pain with minimal side effects. The~     catheter could be placed intra- or extracapsulare. The best position is not known. Primary~     aim is to study if position of the catheter effects the need of other postoperative~     analgesia. Secondary aim is to study if the position effects patient mobility within the~     first two days.~   "
192034|NCT01050725|"~     The purpose of this study is to determine whether specific assays of DNA damage repair~     proteins can be used in patients undergoing radiation therapy. The ultimate goal of this~     research is to develop clinically useful biomarkers from blood samples that could be used to~     customize radiation treatment for individuals, leading to reduced side effects and improved~     outcomes.~   "
192035|NCT01050712|"~     Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care~     problem. It normally occurs in all patients after surgery to the abdomen but in some cases~     can result in serious complications. The objective of this study is to determine if inhaling~     very low doses of carbon monoxide (CO) before and after colon surgery will shorten the~     duration of normal POI and/or prevent the development of POI complications in patients~     undergoing colon surgery.~      A preliminary study will be conducted in six healthy volunteers to monitor for blood levels~     and adverse effects that occur at 3 different doses of inhaled CO to establish a safe dose~     for patients in the main trial. For the main trial, patients requiring surgery to their colon~     will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask~     before and after their operation. Length of normal POI and occurrence of POI complications~     will be compared between the two groups. Side effects that occur from inhaling CO or oxygen~     will also be recorded.~      We hypothesize that inhaling CO before and after colon surgery will shorten the length of~     normal POI and decrease the occurrence of POI complications with minimal side effects.~   "
192036|NCT01050699|"~     The central purpose of this proposal is to study the short-term effects of sedation with~     sympatholysis, using α2 adrenergic agent Dexmedetomidine, on sleep and inflammation in~     critically ill patients with Acute Lung Injury and Acute Respiratory Disorder Syndrome~     (ALI/ARDS). An additional objective is to determine the effect of Dexmedetomidine sedation on~     the in-vitro production of sleep-modulating inflammatory cytokines by peripheral blood~     mononuclear cells of critically ill patients with ALI/ARDS.~   "
192037|NCT01050686|"~     The purpose of this study is to find out whether the insertion of subcutaneous wound drains~     has an influence on postoperative hospital stay in ileostomy reversal.~   "
192038|NCT01050673|"~     It is increasingly recognised that the debridement of devitalised, bacterially contaminated~     or senescent tissue is an essential component of the effective treatment of delayed healing~     wounds.~      Whilst surgical debridement procedures have conventionally been performed with scalpels and~     other sharp instrumentation, alternative techniques such as the VERSAJET Hydrosurgery System~     are becoming more widespread.~      To increase the adoption of this new technology, it is essential that clinical improvements~     are assessed alongside the potential impact on the costs of debridement and the net financial~     impact on the hospital.~      It is hypothesised that a decrease in the time to achieve stable wound closure will not only~     lead to a patient benefit, but also a potential reduction in the cost of treatment due to~     e.g. repeat procedures, longer hospital stay, infection etc. The purpose of this study is to~     investigate the difference in time to closure of wounds surgically excised with VERSAJET~     Hydrosurgery System and those surgically excised using conventional operating room~     techniques.~   "
192039|NCT01050660|"~     The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC)~     is related to the amount of parenteral (intravenous) fat administered to premature babies~     until full enteral nutrition is achieved.~   "
192040|NCT01050647|"~     Preterm birth is the leading cause of neonatal death and a significant cause of life long~     disability and health problems. It has been shown that the drug 17-hydroxyprogesterone~     caproate can help reduce the risk of preterm delivery in women with certain risk factors for~     preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy~     in a group of patients in whom this medication has not been previously studied. Specifically,~     we hope to learn whether progesterone supplementation will delay delivery in women with~     pre-term, premature rupture of membranes (PPROM).~   "
192041|NCT01050634|"~     Quality of life under therapy with Aromasin® (exemestane) according to IBCSG (International~     Breast Cancer Study Group) questionnaire.~      Change of the endometrium after switching from tamoxifen to Aromasin® (exemestane).~      Deeper knowledge of Adverse Events during routine administration.~   "
192042|NCT01050621|"~     Concurrent administration of intravenous vitamin C (ascorbic acid, 1.5 g/kg, infused two or~     three times weekly) together with certain cytotoxic chemotherapy regimens could prove to be~     an effective treatment for some patients with advanced malignancies for whom existing~     chemotherapy is usually ineffective. The primary objectives of this study are to identify a~     tolerable and safe dose of intravenous vitamin C when administered during cytotoxic~     chemotherapy while attempting to empirically identify specific vitamin C-chemotherapy~     regimens for which the clinical response is unusually favorable after a minimum of 2 months~     of therapy, as determined by CT scan and biomarkers, when appropriate.~   "
192043|NCT01050608|"~     Evaluate the efficacy of a multimodal hand hygiene system in the intensive care unit~     environment and evaluate any impact on health care associated infections.~   "
192044|NCT01050595|"~     The purpose of this study is to determine if there will be a significantly higher incidence~     of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with~     decreased need for rescue medications in the intensive care unit in patients with~     opioid-induced constipation. Patients will also be managed with an aggressive bowel~     management protocol.~   "
192045|NCT01050582|"~     The purpose of this study is to evaluate the effects of risperidone compared with other~     atypical antipsychotic drugs on the physical maturity, growth and development of children,~     and the risk of prolactin-related adverse events (side effects) associated to these drugs.~   "
192051|NCT01050504|"~     This research trial collects and studies tissue and blood samples from patients with prostate~     or bladder/urothelial cancer that has recurred (come back) at or near the same place as the~     original (primary) tumor or has spread to other parts of the body. Studying samples of blood~     and tissue samples from patients with prostate or bladder/urothelial cancer in the laboratory~     may help doctors learn more about new biomarkers, potential drug targets, and resistance~     developing in response to treatment. It may also help doctors find better ways to treat the~     cancer.~   "
192052|NCT01050491|"~     Introduction. Despite adequate steroid therapy, a subpopulation of approximately 10% of~     asthmatics develops severe persistent airflow obstruction. It is now widely agreed that the~     latter is the consequence of a remodeling process of the airways, characterized by an~     increase in airway smooth muscle mass, mucus gland hypertrophy, increased thickness of the~     subepithelial basement membrane, extracellular matrix protein deposition, angiogenesis,~     fibroblast and myofibroblast accumulation. These phenomena are responsible for airway wall~     thickening and for decreased airway caliber leading to persistent airflow obstruction.~      Endothelin-1 (ET-1) is a small peptide, synthesized in the lung by airway epithelial and~     smooth muscle cells, as well as inflammatory cells. ET-1 induces bronchoconstriction,~     mediates eosinophils recruitment during allergic inflammation and contributes to airway~     remodeling by inducing fibroblasts and smooth muscle cells differentiation and proliferation.~     In a recent work from Inserm Unit 700, it has been shown that ET-1 was overexpressed in~     epithelial cells from severe asthmatic patients as compared to patients with less severe~     disease, and that ET-1 expression was strongly correlated with airway obstruction (measured~     by FEV1) and on bronchial biopsies with airway smooth muscle areas. In another study, we have~     shown that a polymorphism of the receptor for ET-1 was strongly associated with the degree of~     airway obstruction in a population of asthmatic patients. All these data suggest that~     inhibition of the ET-1 pathway could be a potential therapeutic option in patients with~     steroids refractory asthma and irreversible airway obstruction. Bosentan, a specific~     inhibitor of ET-1 receptors which is actually used in patients with pulmonary hypertension,~     improves survival and inhibits vascular remodeling.~      Aim and strategy. To study the impact on airway remodeling and clinical status of an~     antagonist of the endothelin receptors (Sitaxentan 100mg/day) over a 12-month period, in a~     prospective randomised placebo-controlled trial involving two parallel groups of 25 severe~     asthmatic patients with irreversible airflow obstruction (FEV1≤ 70% of predicted) . Various~     hallmarks of airway remodeling will be analyzed on bronchial biopsy specimens by~     immunohistochemistry and morphometry. These findings will be correlated with the results of~     pulmonary function tests. Twenty-five patients will be included in each group. Remodeling~     will be measured on bronchial biopsies performed during fiberoptic bronchoscopy at inclusion~     and after one year, by assessing smooth muscle area, submucosal fibroblasts count and~     basement membrane thickness. Every 3 months, bronchial obstruction (FEV1), clinical status,~     asthma exacerbations, steroids use, need for emergency care, asthma symptoms and quality of~     life will be assessed. Evaluation of airway inflammation will be assessed every 3 months by~     exhaled NO and induced sputum cytology.~      This proof of concept study will validate ET-1 as a new molecular target for treating airway~     remodeling in patients with severe asthma.~   "
192053|NCT01050478|"~     This study will investigate the effect of paliperidone ER (in combination with or without~     benzodiazepines) in patients presenting with symptoms of agitation and/or aggression in the~     context of psychosis, and will generate data regarding both efficacy and safety in the acute~     setting.~   "
192054|NCT01050465|"~     The specific aim of this proposed pilot study is to compare two standardized processes (paper~     and electronic) to deliver a customized MedlinePlus health information prescription.~   "
192055|NCT01050452|"~     This randomised, controlled, double-blinded clinical study investigates the safety and~     efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and~     MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged~     5-14 years.~   "
192056|NCT01050439|"~     Unrelated matched donor (cord blood, bone marrow or peripheral blood) allogeneic stem cell~     transplantation (UDAlloSCT) with either myeloablative or reduced intensity conditioning will~     be well tolerated and result in a high degree of engraftment in patients with selected~     malignant and non malignant disorders.~   "
192057|NCT01050426|"~     The purpose is to assess the overall survival of patients receiving either UFT/LV +~     radiotherapy (RT) or UFT/LV + Cetuximab + RT after neo-adjuvant chemotherapy.~   "
192058|NCT01050413|"~     This study aimed to evaluate serum thymidine kinase 1 (TK1) activity as a marker for solid~     tumors and more specifically in: preoperative testing for prediction of disease recurrence~     and survival; follow-up after surgical removal of the original tumor for early detection of~     disease recurrence and in monitoring therapy as a surrogate marker of tumor response.~   "
192059|NCT01050400|"~     The purpose of this study is to determine if non-invasive salivary genetic screening of~     breastfeeding mothers taking codeine will allow for the successful identification of~     mother-infant pairs susceptible to adverse events and to prevent these adverse events by~     personalizing their medication to their genetics.~   "
192060|NCT01050387|"~     The purpose of this study is to determine if the vitamin D binding protein genotype~     influences circulating vitamin D levels and if it may have functional consequences on vitamin~     D activity.~   "
192061|NCT01050374|"~     This randomised, controlled, double-blinded clinical study investigates the safety and~     efficacy of MBD in combination with PZQ in the treatment of SCH and STH in children aged 1-15~     years of age.~   "
192062|NCT01050361|"~     The growing population of University of Nebraska Medical Center patients with heart failure~     combined with the increasing number of surgical procedures performed each year supports the~     need for a critical analysis of how to most appropriately manage these patients during the~     perioperative period, especially for non-cardiac surgery. Echo-guided hemodynamic management~     (EGHEM) is the use of echocardiography data to normalize and/or optimize in real-time,~     cardiac output and ventricular filling pressures in the perioperative period for non-cardiac~     surgical cases. The purpose of this study is to test the hypothesis that EGHEM compared to~     standard management practices will result in a reduced length of hospital stay in the~     noncardiac surgery population. The primary goal of health care providers for patients~     requiring anesthetic care, perioperative care, or critical care is ensuring the adequacy of~     the patient's circulatory function by optimizing cardiac output and ventricular filling~     pressure. Currently, the use of the ECG monitor and systemic blood pressure are the standard~     of care for assessing circulatory function. However, those data cannot provide accurate~     information on cardiac output and ventricular filling pressure for patients with~     cardiovascular risk factors and/or comorbidities. As a result, managing the hemodynamic~     parameters of these patients, as well as their intravenous fluid needs and resuscitation~     strategy, we hypothesize that using traditional approaches may lead to significant volume~     overload and post-operative cardiovascular complications and morbidity. In this study we~     propose an EGHEM strategy that incorporates standard echocardiography generated data points~     in addition to the systemic blood pressure and ECG signal to assess, manage, modify and~     optimize patient cardiac preload, afterload, heart rate and contractility in the~     perioperative period. Based on our initial observations and preliminary data using the EGHEM~     approach, we hypothesize that we can demonstrate a significant decrease in hospital length of~     stay and an overall decrease in perioperative morbidity at 30 days in the non-cardiac surgery~     population using EGHEM compared to standard practices. In this proposal we have designed a~     single center, prospective, randomized clinical trial to test our hypothesis.~   "
192063|NCT01050348|"~     This is a double-blinded randomized placebo controlled trial investigating the role of~     upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for~     acute STEMI.~   "
192064|NCT01050335|"~     The purpose of this study is to provide a quantitative base line comparison to determine a~     surgeon's proficiency based on that surgeon's hand and tool movements while performing~     simulation tasks.~   "
192065|NCT01050322|"~     Despite these initial positive signals in recent statistics, breast cancer continues to claim~     a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current~     treatment paradigm - surgery, radiation and systemic chemo and or hormonal therapy and~     biological therapies -still fails to cure a significant number of women with early breast~     cancer and new treatment strategies are needed to improve current results both in early and~     advance disease.~      Recurrent or metastatic breast cancer is an incurable malignancy with a median survival of~     20-24 months [Hortobagyi , 1998] and this has not changed significantly over the last decade~     with fewer than 20% of patients still alive at 5 years after a diagnosis of recurrence.~     Although there have been small improvements in survival with the new therapies, metastatic~     breast cancer remains an incurable and, ultimately, fatal disease. The introduction of novel~     combination therapies have the potential to target different pathways in the cancer cell,~     leading to improved efficacy. Further studies to optimize combination therapy, while~     ameliorating AEs, are critically important to patients with metastatic breast cancer.~      Lapatinib is an oral tyrosine kinase inhibitor which potently inhibits both EGFR and~     HER2[Spector, 2005]. Lapatinib in combination with capecitabine is approved in more than 20~     countries for the treatment of patients with advanced or metastatic breast cancer whose~     tumors overexpress HER2. All patients in the study leading to the lapatinib approval had~     received prior therapy including an anthracycline, a taxane, and trastuzumab.~      The relevance of the HER2/neu target in breast cancer, combined with the promising~     preclinical and clinical data regarding the use of lapatinib, provide the rationale for a~     formal evaluation of this agent combined with other non taxane agents as gemcitabine or~     vinorelbine after progression on taxanes and trastuzumab based therapies in metastatic~     disease setting as these chemotherapy options are used in daily practice in this subset of~     patients.~      This is a randomized phase II, open label,multicentric , international, 3 arms treatment~     study in patients with confirmed HER2+ metastatic breast cancer after taxane progression .~     The main objective is to investigate the (CBR) and safety in 3 different combinations of~     Lapatinib therapy (plus capecitabine or gemcitabine or vinorelbine) and to determine whether~     either, or both, of Lapatinib /Vinorelbine or Lapatinib/Gemcitabine can be considered a~     reasonable alternative to the established Lapatinib/Capecitabine standard combination . The~     decision as to whether to study either of the new combinations further will be based on both~     the toxicity and the efficacy profiles.~   "
192115|NCT01049672|"~     OBJECTIVES:~      How does Alfentanil compare with the standard drug Diamorphine for subcutaneous analgesia in~     the palliative care setting?~      STUDY DESIGN:~      An open-label pilot comparison between alfentanil and diamorphine for palliative care~     patients who require subcutaneous opioids.~   "
192066|NCT01050309|"~     The study will determine the extent of systemic absorption of HAL following vaginal and enema~     administration compared to intravenous administration to healthy female volunteers.~      In addition, the pharmacokinetic parameters for the combined level of 14C labelled substances~     (sum of parent and possible metabolites)will be assessed. The safety and tolerability of HAL~     following vaginal, enema and intravenous administration to healthy female volunteers will be~     investigated.~   "
192067|NCT01050296|"~     This study will prospectively characterize the molecular, cellular and genetic properties of~     primary and metastatic neuroblastoma, osteosarcoma, retinoblastoma, Ewing sarcoma family of~     tumors, soft tissue sarcomas, adrenocortical tumors and liver malignancies. These cell~     isolates will be used for gene expression array analysis, genomic analysis by [SNP] single~     nucleotide polymorphism chip, array [CGH] comparative genomic hybridization and next~     generation sequencing, and [TEM] transmission electron microscopy analysis. Additionally cell~     lines and orthotopic xenografts will be created from the obtained tumor specimens.~      The specificity of TCRs will be examined by comparing paired TCR from peripheral blood and~     tumor infiltrating CD4+ and CD8+ T cells. Epigenetic studies will be performed looking at the~     methylation profile of these cells and to investigate the anti-tumor T cell response both~     pre- and post-PD1 inhibition.~   "
192068|NCT01050283|"~     This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography~     (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.~   "
192069|NCT01050270|"~     This study is designed to assess the impact of new approaches to therapy for paracetamol~     poisoning. Standard therapy is currently acetylcysteine by intravenous infusion over 20.25h.~     This regimen is given to those deemed at risk using standard criteria (British National~     Formulary 200920). It has 3 major problems, adverse events (nausea and vomiting and~     anaphylactoid reactions), therapy duration and complexity of administration.~      This study is primarily designed to test the efficacy of prophylactic anti-emetic therapy.~      It will also provide sufficient experience and data from a modified shortened IV~     acetylcysteine regimen to adequately design and power a study of the modified regimen as a~     new treatment for this common poison. Such an approach has a major potential to reduce~     patient adverse events from acetylcysteine therapy and shorten duration of hospital stay.~   "
192070|NCT01050257|"~     This partially randomized, multi-center parallel-group study will evaluate the safety,~     pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in~     patients with influenza. Adult and adolescent patients will be randomized to receive either~     100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are~     blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral~     Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days,~     with an optional treatment extension of a further 5 days, if necessary. There will be a~     non-randomized, open-label treatment group for patients with moderate/severe renal impairment~     or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to~     their renal situation.~   "
192071|NCT01050244|"~     Neuropathic pain is one form of chronic pain lacking effective pharmacotherapy. Interest in~     the role of complementary and alternative medicine is growing and diet is at the forefront of~     the search for alternative treatments for pain. Soy protein is one of the most promising~     dietary ingredients tested for its pain-relieving properties. Results from animal studies~     show that soy-enriched diets reduce pain due to nerve injury. The purpose of this study is to~     determine the effects of soy protein supplementation on facial pain.~   "
192072|NCT01050231|"~     The purpose of this study is to develop an upper extremity robotic training system for use by~     people with stroke to practice arm and hand movement in the clinic.~   "
192073|NCT01050218|"~     The purpose of the study is to learn if long-term treatment with DVS SR is safe for treating~     the pain and other symptoms associated with diabetic peripheral neuropathy.~   "
192074|NCT01050205|"~     The Diabetes Prevention Program (DPP), a large research study conducted in the United States,~     found that lifestyle intervention was effective in lowering risk for development of type 2~     diabetes. It is important to evaluate the DPP lifestyle interventions in real world~     settings. The purpose of this project is to test an adapted version of the DPP lifestyle~     intervention in several community settings, including a worksite, a health care facility~     (primary care practice and local community centers dedicated to older adults.~   "
192075|NCT01050192|"~     The purpose of this study is to determine the correlation, if any, between the nutritional~     content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the~     neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in~     a 24 hour period, since as a practical matter, these may not be the same.~   "
192076|NCT01050179|"~     The purpose of this study is to assess chemoreflex gain on exercise.~   "
192077|NCT01050166|"~     The purpose of the study is to determine whether human islets labeled by iron contrast agents~     could be imaged using magnetic resonance after transplantation into the liver of Type 1~     diabetic recipients.~   "
192089|NCT01050010|"~     The major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural~     radiographic progression is observed in 15 to 20% of patient getting remission. Numerous~     definitions of the remission proposed by literature remain imperfect.~      Recently ultrasonography and MRI seem to be helpful in diagnosis and follow-up of rheumatoid~     arthritis.~      Studies in patients with clinical remission are reporting 75 to 90% of persistent MRI and~     ultrasonography synovitis, 45% of cases with synovial activity.~      To our knowledge, in such case few studies showed correlation between persistent imaging~     synovitis and structural radiographic progression.~      On the other hand, no studies with extremity dedicated RMI in patients with remission are~     reported.~      In this preliminary study, the investigators propose to evaluate in patients with rheumatoid~     arthritis remission and persistent dedicated MRI synovitis the structural radiographic~     progression at one year.~   "
192090|NCT01049997|"~     The purpose of this study is to describe patients, 75 years old or older, with Non ST~     Elevation Myocardial Infarction (NSTEMI) especially regarding the following variables:~     cardiovascular risk, co-morbidity and frailty. The investigators hypothesize that the degree~     of frailty influences the benefit from coronary angiography and the possible invasive~     treatment which can follow.~   "
192078|NCT01050153|"~     This study plans to learn more about how to prevent blood clots in the veins of your~     extremities. You are at risk of forming these clots after a major injury and when you have~     had surgery and are hospitalized on bed rest.~      Usually, patients in the SICU at Denver Health who are at risk for blood clots receive~     preventative treatment with a FDA-approved medicine called Fragmin. Fragmin is intended to~     prevent blood clots from forming but, with the way it is generally used, some patients may~     still develop blood clots. All patients treated with Fragmin to prevent blood clots at Denver~     Health, currently receive the same Fragmin dose. This treatment is called the standard of~     care.~      So far, in the US, there has not been a commonly available test that can tell us:~        -  if the standard dose of Fragmin is enough to prevent blood clots for everyone, or~        -  if different patients need different doses, or~        -  if other blood clot preventing medicines, that work in a different way, should be used~          in addition to Fragmin.~      The ability of your blood to clot and the strength of the clot formed can be described by a~     FDA-approved blood test called thrombelastography, referred to as TEG. TEG may provide us~     with answers to each of the questions above. Our preliminary data indicate that it is helpful~     in assessing both clotting and bleeding tendencies and may prove useful in guiding treatment~     for the prevention of blood clots.~      The aim of this study is to determine if a treatment plan using Fragmin, and, if indicated,~     one or two additional FDA-approved medicines called anti-platelet drugs, guided by the~     results of TEG testing, may be better at preventing blood clots than our current standard of~     care.~   "
192079|NCT01050140|"~     Dietary consumption of fructose has increased by nearly 50% since 1960.~      A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin~     resistance than a high glucose diet. The effects of fructose on liver fatty acid and ATP~     stores, systemic oxidative stress and cardiovascular status are not fully known.~   "
192080|NCT01050127|"~     The objectives of this study are to assess the safety, tolerability, pharmacodynamics and~     pharmacokinetics of multiple doses of ABT-436 in healthy adults.~   "
192081|NCT01050114|"~     Overactive bladder is a condition associated with symptoms of feeling the urge to urinate,~     urinating often, and may or may not be accompanied by leakage of urine. A patient who has a~     spinal cord injury (SCI) often suffers from an overactive bladder which often leads to~     urinary incontinence (UI - an unwanted leakage of urine).~      OnaBoNT-A bladder injections have been studied in clinical research trials. The results have~     shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by~     increasing the amount of urine the bladder can hold.~      This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when~     injected into the bladder for the treatment of UI and if it works better than a drug that is~     taken by mouth. A second purpose of the study is to perform research tests on the urine~     samples provided by the volunteers. Urine presents a rich source of information for bladder~     diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to~     learn if there are yet undiscovered reasons for urinary diseases. These tests would be very~     beneficial because the results would lead to better treatment of the urinary diseases.~      Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo~     oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg~     capsule twice a day.~      The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or~     placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo~     contains no active medicine. Participation in this study will be about 6-7 months and involve~     5 visits to the clinic. The risks of bladder onaBoNT-A~   "
192082|NCT01050101|"~     In this research study, investigators are interested in how certain dietary fibers in the~     diet affect certain hormones released from your intestine after eating and how these~     influence your appetite. The study hypothesis is that certain fibers will slow digestion and~     absorption of nutrients thereby optimizing fullness,reducing food intake and limiting insulin~     response in pre- and post-menopausal women.~   "
192083|NCT01050088|"~     Babies with congenital clubfeet are treated by the Ponseti casting method. The procedure may~     cause discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as~     a comforting agent for the babies.~   "
192084|NCT01050075|"~     RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy.~      PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating~     nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving~     paclitaxel.~   "
192085|NCT01050062|"~     The survey is conducted to collect safety and effectiveness information in Hypertensive~     patients treated with Micombi Tablets on the long term use in daily clinical settings in~     Japan.~   "
192086|NCT01050049|"~     The objective of this study is to determine if the implementation of guidelines utilizing~     immediate CT Perfusion and CT Angiography in addition to non-contrast CT alters (reduces or~     increases) the time to decision-making for or against rt-PA in acute ischemic stroke, and by~     extension, time to therapy in treated patients and time to transfer from the department for~     all patients. A secondary objective is to determine if using CTP/CTA-inclusive hyperacute~     stroke guidelines improves safety by decreasing symptomatic intracerebral hemorrhage and~     mortality in patients who receive rt-PA.~   "
192087|NCT01050036|"~     Primary study objective is the evaluation of efficacy of autologous hematopoietic cell~     transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in~     the first CR (CR1) in terms of relapse incidence (cumulative incidence of relapse, CIR) and~     disease-free survival (DFS).~      Secondary study objectives are the engraftment rate / time to engraftment,~     transplantation-related mortality (TRM) rate, event-free survival (EFS) rate, and Overall~     survival (OS).~   "
192088|NCT01050023|"~     This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a~     radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to~     improper functioning of valves in the veins, usually of the legs) will result in increased~     rates of healing and a larger proportion of completely healed wounds after 12 weeks of~     therapy compared to wounds treated identically using a Provant device that is not activated~     to emit radiofrequency.~   "
192091|NCT01049984|"~     To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist~     therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine~     agonists as compared to placebo.~   "
192092|NCT01049971|"~     Surgical site infection is common in colorectal surgery leading to increased postoperative~     pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence,~     reducing the wound infection rate is a major aim in abdominal surgery.~      Wound protectors were invented for retracting the abdominal wall and keeping the abdominal~     wall sterile in order to reduce bacterial colonialization of the wound and wound infections.~      This is a prospective-randomized trial comparing use of wound protectors versus woven drapes~     in laparoscopic colon resections with minilaparotomy.~   "
192093|NCT01049958|"~     This study will examine the prevalence of patient-ventilator asynchrony and its determinants.~     Mechanically ventilated trauma patients often experience asynchrony when their pattern of~     breathing does not match the triggering of a mechanical ventilator.~      Asynchrony is thought to be more common in delirious patients, patients with chronic lung~     disease and those who are heavily sedated. The study will examine the relationship between~     (1) delirium and sedation and (2) the prevalence of asynchrony in trauma patients.~   "
192094|NCT01049945|"~     RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Lenalidomide may stimulate the immune system in different ways~     and stop cancer cells from growing. Giving bendamustine hydrochloride together with~     lenalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is~     studying the side effects and best dose of bendamustine hydrochloride and lenalidomide when~     given together with dexamethasone and to see how well they work in treating patients with~     relapsed multiple myeloma.~   "
192095|NCT01049932|"~     Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using~     antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is~     a new drug being developed for this type of HIV treatment. It is hoped that this drug may be~     used to help prevent HIV transmission in future. A 'long acting' formulation of TMC278 has~     been developed. Long acting means that the drug will be present in the blood for longer. It~     is this formulation of the drug that will be investigated in this study. Subjects will~     receive the drug by injection.~      The purpose of this study is to investigate the safety of the drug and how well it is~     tolerated by the body. The study will look at the levels of the study drug in the subjects~     blood over the duration of the study.~   "
192096|NCT01049919|"~     This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA)~     to prevent or delay major amputation and/or death in subjects with critical limb ischemia~     (CLI) due to severe peripheral arterial disease (PAD).~   "
192097|NCT01049906|"~     Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and~     motor blockade obtained with stimulating popliteal catheters versus those placed without~     nerve stimulation.~   "
192098|NCT01049893|"~     AC220 will be administered as a once daily oral solution given continuously as 28-day~     treatment cycles, without food and without any rest periods, as long as there is no evidence~     of disease progression or unacceptably severe adverse events (AEs) related to the study drug.~   "
192099|NCT01049880|"~     This study is designed to determine the maximum tolerated dose of vitamin C when given with a~     standard chemotherapy for people who have metastatic pancreatic cancer.~   "
192100|NCT01049867|"~     The aim of this study is to evaluate if the intracoronary infusion of autologous bone-marrow~     derived CD133+ endothelial precursor cells is able to promote neovascularization and to~     improve myocardial perfusion and contractility in patients with refractory coronary heart~     disease, characterized by poor response to standard coronary interventions, severe impairment~     of the quality of life, and poor prognosis.~   "
192101|NCT01049854|"~     CD34+ stem cell selection in children, adolescents and young adults receiving partially~     matched family donor or matched unrelated adult donor allogeneic bone marrow or peripheral~     blood stem cell transplant will be safe and well tolerated and be associated with a low~     incidence of serious (Grade III/IV) acute and chronic graft versus host disease (GVHD).~   "
192102|NCT01049841|"~     The purpose of this study is to test the safety and effectiveness of 2 drugs, perifosine in~     combination with temsirolimus in children with solid tumors. Neither drug is currently part~     of the standard treatment of solid tumors in children. Both drugs have been tested alone to~     treat solid tumors in children with little success. There is now new insight that if given~     together, perifosine and temsirolimus may work together to stop the growth of solid tumors~     and may also make them shrink. The doctor wants to find out what effects; good and/or bad,~     perifosine in combination with temsirolimus has on the patient and the cancer. The doctors~     are testing four different dose schedules of perifosine with temsirolimus and the patient~     will be asked to partake in one of the dose schedules. The dose schedule will be lower for~     those enrolled early in the study.~   "
192103|NCT01049828|"~     Tinnitus is the occurrence of an auditory sensation without the presence of an acoustic~     stimulus. Approximately, 50 million people in the United States experience chronic tinnitus~     and 15 million of these people have bothersome tinnitus. Several studies have shown that~     people who are bothered by their tinnitus have difficulty in concentration and focus. Through~     imaging modalities we have deranged neural networks responsible for attention. Only 20~     percent of patients diagnosed with tinnitus are severely bothered. We seek the following:~        1. Match a group of non-bothered tinnitus patients on age and hearing status to an existing~          cohort of bothered tinnitus patients.~        2. Assess the resting-state neural connectivity in patients with non-bothersome tinnitus.~          Findings from the comparison of functional connectivity magnetic resonance imaging~          (fcMRI) from subjects with bothersome tinnitus in our current rTMS clinical trial to~          normal age-matched controls without tinnitus demonstrates that subjects with bothersome~          tinnitus have dramatic alterations in cortical attention and control networks. Our~          hypothesis is that the fcMRI-defined changes in the attention and control networks~          reflect the impact of excessive auditory stimulation in patients with bothersome~          tinnitus and explains the difficulty with concentration, short-term memory, and other~          common problems. To fully test this hypothesis we need to obtain fcMRI of the attention~          network among subjects with tinnitus but without bother and compare the status of their~          neural networks with those of tinnitus subjects with bother and with normal controls.~        3. Compare the resting cortical networks in subjects with non-bothersome tinnitus to~          subjects with bothersome tinnitus and subjects without tinnitus Our null hypothesis is~          that there are no differences in the resting-state cortical networks, especially the~          attention and control networks, between tinnitus patients who do not experience bother,~          tinnitus patients who do experience bother, and subjects without tinnitus. Through~          fcMRI, we will examine correlations in blood oxygen level dependent (BOLD) signals in~          established auditory, attention, control, and other brain regions in the resting brain~          and compare these findings to already collected fcMRI scans of bothered tinnitus~          patients, and controls (patients without tinnitus).~   "
192104|NCT01049815|"~     Aims of the multi-center, randomized, treatment-controlled clinical trial are to compare the~     efficacy of sevelamer hydrochloride to calcium-containing phosphorus binders in reducing the~     rate of progression of femoral and carotid intimal media thickness (IMT) thickening as~     measured by B-mode ultrasound in stable maintenance hemodialysis (HD) patients.~   "
197872|NCT00973037|"~     The purpose of this study is to investigate the impact of CYP2D6 Genotype on the clinical~     effects of tamoxifen using with samples from prospective randomized multicenter~     study(ASTRRA).~   "
192105|NCT01049802|"~     This is a prospective randomized controlled feasibility study to determine whether navigation~     guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in~     patients with subacute stroke has a beneficial effect when given concurrently with~     task-oriented motor rehabilitation of the arm and hand. Navigation guided rTMS requires a~     structural MRI scan for targeting stimulation and therefore structural MRI will be performed~     on all subjects. In addition the study intends to determine whether measures of motor tract~     integrity (MTI) assessed by navigated brain stimulation (NBS) and MRI diffusion tensor~     imaging can be used to clarify prognosis of motor recovery and to monitor progress with~     rehabilitation. 30 subjects with ischemic or hemorrhagic stroke 3-9 months prior to~     enrollment and with residual upper limb hemiplegia will be randomized to receive either 1 Hz~     rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with~     rehabilitation therapy or sham rTMS to the contralesional hemisphere for 30 minutes 3 times a~     week for 6 weeks along with rehabilitation therapy. Primary outcome is improvement on the~     Action Research Arm Test, a measure of arm and hand function in people with stroke. Outcomes~     will be measured immediately post treatment, and at 3 months and 6 months post treatment.~   "
192106|NCT01049789|"~     This is a two-phase study that is designed to test a novel behavioral intervention to treat~     depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four~     Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive~     Behavioral Therapy and Medication Management (COMB) treatment group or the Treatment as Usual~     (TAU) group.~      Phase I involves pilot testing of a 24-week intervention consisting of Cognitive Behavioral~     Therapy (CBT) and Medication Management (MM) manuals at sites assigned to the COMB treatment~     group. Participants enrolled at TAU sites will receive treatment for depression that is~     typical at that site, which may include medication management, psychosocial therapy, or a~     combination of the two. Psychopharmacological and psychosocial interventions will not be~     standardized and participants may receive any depression treatment recommended by the site~     clinicians while on study. Study coordinators and site clinicians, regardless of group~     assignment, will document depression symptoms and treatment regimens for all participants for~     24 weeks. In addition, site staff and participants at COMB sites will participate in an exit~     interview. The findings from these interviews will be used to revise both CBT and MM~     intervention manuals at the end of Phase I.~      Phase II is a feasibility study of the revised CBT and MM manuals. Phase II involves similar~     procedures as Phase I; sites assigned to COMB will implement the revised CBT and MM manuals.~     Participants at TAU sites will receive treatment for depression that is typical at that site.~     As in Phase I, psychopharmacological and psychosocial interventions will not be standardized~     and participants may receive any depression treatment recommended by the site clinicians~     while on study. Depression symptoms and treatment regimens for all participants will be~     documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits~     at weeks 36 and 48. Again, site staff and participants at COMB sites will participate in an~     exit interview. The findings from these interviews will be used to revise both CBT and MM~     manuals at the end of Phase II.~   "
192107|NCT01049776|"~     Lung Cancer is the most common cause of cancer death in the United States with an estimated~     mortality in excess of 160,000, more than the combined mortality seen with prostate, breast,~     colorectal cancers(1). Most patients with Lung Cancer have Non-Small Cell Lung Cancers(~     NSCLC) and only 25-30% of patients with NSCLC (Non Small Cell Lung Cancer) have resectable~     disease( Stage I or II) at the time of diagnosis.~      The vast majority of patients with advanced NSCLC (Non Small Cell Lung Cancer) are not~     curable and overall five year survival is 11%-14%1.~      Chemotherapy is beneficial for patients with locally advanced and metastatic disease.~     Numerous phase III studies have determined the superiority of systemic chemotherapy over best~     supportive care. Platinum based chemotherapy has been widely accepted as the standard of care~     for the initial treatment of advanced NSCLC.~      However first line chemotherapy is modest at best. A randomized trial comparing four of the~     most commonly used chemotherapy regimens in the United States not only failed to show a~     clearly superior arm but also confirmed the dismal prognosis of these patients. The response~     rate for all 1207 patients was 18.6% with a median survival of eight months and one year~     survival of 33.5 % and a two year survival of 12%5. Clearly a different paradigm is needed~     for the treatment of this disease.~   "
192108|NCT01049763|"~     This study is planned to characterize the pharmacokinetic properties of oseltamivir and the~     active product--oseltamivir carboxylate--in obesity in order to provide clinical guidance for~     the optimum oseltamivir treatment regimens for severe influenza. It is also a prompt response~     to a new era influenza plan along with recognition of growing numbers of obese persons.~      The study findings will be available for a future management plan in dealing with this virus~     that is transmitted easily from person to person and has shown substantial antigenic changes~     over time.~      The primary focus of statistical analysis is to verify the effect of obesity on~     oseltamivir/oseltamivir carboxylate pharmacokinetics as measured by oseltamivir carboxylate~     Cmax, AUC (0-12), AUC (0-24), C12, λz, and t1/2 and oseltamivir Cmax, AUC (0-12), and C12.~   "
192109|NCT01049750|"~     The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will~     undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety~     state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will~     evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima~     Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform~     MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability~     Score)questionnaires.~   "
192110|NCT01049737|"~     The purpose of this study is to prospectively explore the impact from the different~     cardiovascular risk factors on early cardiovascular organ damage in 761 middle aged patients~     with type 2 diabetes.~   "
192111|NCT01049724|"~     The purpose of this study is to measure tear lacritin and heparanase levels before and~     following surgery using a minimal risk procedure to collect tears from patients undergoing~     PRK or LASIK.~   "
192112|NCT01049711|"~     To study the cost utility analysis of Erythropoietin (EPO) for maintaining the different~     hemoglobin (Hb) target levels in anemic hemodialysis patient in routine clinical practice.~   "
192113|NCT01049698|"~     Aging is associated with declines in muscle strength, power, and overall functional ability~     that lead to disability and loss of independence. Furthermore, the existing high prevalence~     of obesity in the elderly is greatly exacerbating these aging-related declines in function.~     To date, regular exercise, especially resistance exercise, is the only known treatment to~     consistently improve muscle function and perhaps delay the onset of disability. However, not~     all individuals experience the same magnitude of benefit from a given exercise stimulus, and~     accumulating data show that obesity limits muscle adaptations to chronic exercise.Therefore,~     the proposed study is designed to determine the effects of caloric restriction on~     improvements in skeletal muscle function in response to RT.~   "
192114|NCT01049685|"~     Retrospective longitudinal cohort study with 36 HIV naïve-treatment patients, who started~     therapy with lopinavir/ritonavir or efavirenz (LPV/r or EFZ), follow-up of 36 months. Primary~     endpoint: virological success (HIV RNA <50 copies/mL) in the first six months and at the end~     of the study.~   "
198597|NCT00963469|"~     This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning,~     versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the~     study as an active control.~   "
192116|NCT01049659|"~     The investigators have shown that Nice area, like most of France, remains an area of mild~     iodine deficiency. The investigators want to assess the potential benefit of early iodine~     supplementation during pregnancy in women with normal thyroid function on the~     neuropsychological development of their children assessed at the age of two with the Bayley~     test.~   "
192117|NCT01049646|"~     The apelin-APJ system is a relatively new discovery. It has generated interest in part due to~     it's apparent ability to counteract the renin-angiotensin system, which is frequently~     overactive in many cardiovascular disease.~      Apelin improves that pumping ability of the heart and we wish to know if this action persists~     in the presence of increased levels of angiotensin II.~   "
192118|NCT01049633|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells~     are destroyed, resulting in poor blood sugar control. The purpose of this study is to~     determine the safety and effectiveness of islet transplantation, combined with~     immunosuppressive medications and medications to support islet survival for treating type 1~     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic~     episodes.~   "
192119|NCT01049620|"~     It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and~     Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the~     growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control~     gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in~     combination with conventional chemotherapy. In this study, XELOX was selected as a~     conventional combination chemotherapy because it was proven very active and safe in gastric~     cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer~     patients yet. So, the optimal dose will be first determined in this phase I study~   "
192120|NCT01049607|"~     There is clinical uncertainty and ongoing discussion among liver surgeons regarding the~     optimal method of parenchymal transection in patients undergoing elective hepatic resection.~     While the clamp-crushing technique still represents the reference technique for routine liver~     resections, transection of liver parenchyma using vascular staplers may offer a new and safe~     technique potentially reducing intraoperative blood loss, operation time as well as~     peri-operative morbidity. As morbidity of patients undergoing hepatic resection remains high,~     approaches to lower peri-operative complications are urgently required. Due to the lack of~     evidence it has to be evaluated, if the technique of stapler hepatectomy decreases~     intraoperative blood loss as a highly relevant predictor of peri-operative complications,~     patients' hospital stay and finally health care expenditures. These advantages would favor~     stapler hepatectomy to be applied in routine liver resections. As RCTs are generally~     considered to generate the most valid scientific evidence on a treatment's effects, the~     present trial evaluates potential benefits of stapler hepatectomy in a randomized fashion.~   "
192121|NCT01049594|"~     Preterm infants face an uncertain future because premature birth often leads to problems with~     brain development and can cause cerebral palsy.~      A trial needs to be done to see if Magnetic Resonance Imaging (MRI) helps families and~     professionals by predicting long term problems more accurately, allowing better targeting of~     care to children with problems and reassuring the parents of normal babies.~      This programme will provide the evidence-base for the National Health System (NHS) policy on~     the use of magnetic resonance imaging of the brain for preterm infants.~   "
192122|NCT01049581|"~     Aquatic intervention had been applied in children with neuromotor impairment for years, yet~     there has been little progress toward objective identifications of therapy goals,~     interventions, and outcomes. Thus, we attempt to design aquatic intervention activity for~     children with cerebral palsy to evaluate the effect of hydrotherapy.~      Purpose:~      To evaluate the effects of pediatric aquatic therapy on motor performance, daily activity and~     social participation in children with spastic cerebral palsy.~      Method:~      The study enrolled 27 children with spastic cerebral palsy aged from 4 to 12 years old.These~     children were dived into two groups: traditional rehabilitation therapy (control group), and~     hospital based pediatric aquatic therapy program. We evaluate the motor performance, daily~     activity and social participation before and after the intervention and compared the~     difference in improvement between groups. The measurements include modified Ashworth score,~     Gross Motor Function Measure (GMFM -66), Vineland Adaptive Behavior Scale (VABS) , and~     Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL).~      Expect effect:~      We suppose pediatric aquatic therapy in spastic cerebral palsy children could improve motor~     function and daily activity.Children could improve self-esteem and we hypothesize this could~     improve social participation.~   "
192123|NCT01049568|"~     This study will use a longitudinal, experimental design. Participants will be randomized to~     either the intervention or the control group.~      The intervention will involve cell phone support, including reminders, assessment of barriers~     to adherence, problem solving and referrals conducted by an Adherence Facilitator.~      Control group participants will participate in all on-study evaluations, except the~     intervention exit interviews.~   "
192124|NCT01049555|"~     Neuropsychiatric symptoms form part of the clinical picture of Alzheimer's disease (AD) and~     other dementias. Irrespective of the severity of the disease, the most frequently encountered~     symptom is apathy. Apathy is increasingly diagnosed in patients with neurological and~     psychiatric conditions. Apathy is a disorder of motivation, defined as the direction,~     intensity and persistence of goal-directed behaviour. Most of the current descriptions~     acknowledge this point and consider apathy in terms of a lack of goal-directed behaviour,~     cognition or emotion. The classical neuropsychiatric symptom assessments are subjective~     structured interview-based, using input from the caregiver and/or the patient. New~     technologies are likely to provide us with a more objective measure. An example is ambulatory~     actigraphy, consisting of a piezoelectric accelerometer designed to record arm movement in~     three dimensions.~      The aim of the present study is to assess using actigraphy and video recording signal, AD~     patients with (n = 15) and without (n = 15) apathy and control subjects (n = 5) during an~     activity of daily living scenario .~   "
192262|NCT01047761|"~     Generalized fatigue in myasthenia gravis results in physical deconditioning that reduces~     fitness and increases risk of obesity, hypertension, elevated cholesterol and type 2~     diabetes. This study will examine how active and fit are 30 individuals with chronic,~     generalized myasthenic subjects. This study will also determine whether a 3 month home~     exercise program with aerobic, resistive, and pulmonary training can improve physical~     activity, strength, fitness, lung function and reduce cardiovascular disease risk.~   "
192125|NCT01049542|"~     Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem~     with a poor prognosis and the search for novel treatments remains an important area of~     research.~      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There~     has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in~     heart failure.~      In this study, we will examine the effects and mechanisms of Urocortins 2 & 3 and the~     Corticotrophin Releasing Hormone Receptor Type 2 (CRH-R2) receptor (through which urocortins~     act) on forearm blood flow and release of natural blood clot dissolving factors in the~     forearm circulation of healthy volunteers.~      In this study, we will look at the role of the lining of the blood vessel (endothelium) in~     response to urocortin types 2 and 3. We hypothesise that urocortins 2 & 3 act via the~     endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen~     activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a~     role in maintaining the normal baseline level of blood flow in forearm arteries. In addition~     to the above, we will also look at the effect of temporarily blocking the effect of~     urocortins, using a specially designed blocker drug (Astressin 2B).~      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we~     will be able to focus on the local effects of urocortins on arterial blood flow in forearm~     vessels, without affecting this system in the body as a whole.~   "
192126|NCT01049529|"~     The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration~     attenuates the inflammatory cytokines and improve clinical outcomes in neonates who underwent~     cardiovascular surgery~   "
192127|NCT01049516|"~     The purpose of this study is 1) to evaluate whether massing 10 PE sessions in 2 weeks (massed~     trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed~     sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8~     weeks (spaced trials; S-PE), and 3) to evaluate for the first time the efficacy of the 10 PE~     sessions delivered in 8 weeks in an active duty population by comparing it to an active~     comparison condition, Present-Centered Therapy (PCT).~   "
192128|NCT01049503|"~     This study aims to assess the overall effect of pH and fluoride concentration of liquid~     dentifrices in the control of children dental caries of a fluoridated area, through visual~     inspection and the quantitative light-induced fluorescence (QLF) method. Toenail F~     concentration of a subsample of the children enrolled will be evaluated, in order to assess F~     bioavailability from these formulations and the evaluation of the concentration of fluoride~     incorporated into the biofilm will be done 6 months after initiation of the dentifrices use.~   "
192129|NCT01049490|"~     Primary objective: To evaluate the safety and immunogenicity of low-dose ID S-OIV H1N1~     vaccines delivered via a novel microneedle device (MicronJet600) and compare this to the~     full-dose standard IM injection.~      Hypothesis: Low dose (20%) intradermal (ID) S-OIV H1N1 vaccine delivered via a novel~     microneedle device (MicronJet600) is equally effective as full-dose standard intramuscular~     (IM) vaccine.~   "
192130|NCT01049477|"~     The purpose of the study is to determine if listening to your choice of music with a portable~     mp3 player before and after a cesarean section for delivery of a baby will decrease the~     patient's anxiety level.~   "
192131|NCT01049464|"~     The purpose of this study is to determine the efficacy of Magnesium sulphate for the rate and~     rhythm control of the new onset (within 48 hours) atrial fibrillation in the hemodynamically~     unstable patients, admitted in the medical intensive care unit patients.~   "
192132|NCT01049451|"~     We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as~     Acthar Gel® (MANUFACTURER NAME) is effective in the control of clinical disease activity as a~     pulse therapy for relapsing-remitting MS when added to standard treatment with~     beta-interferon.~      We wish to determine whether ACTH, when administered as clustered monthly intramuscular~     injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and effective~     alternative to monthly pulse therapy with MP. In addition, we hypothesize that pulse therapy~     with ACTH alters immune function to favor a regulatory, rather than a pro-inflammatory T cell~     environment.~   "
192133|NCT01049438|"~     This clinical trial tests the hypothesis that body decolonization of patients with recurrent~     community-associated (CA) MRSA infections will significantly reduce the likelihood of~     recurrent CA-MRSA infection.~   "
192134|NCT01049425|"~     The planned trial compares an anthracycline-free taxane based regimen versus a modern third~     generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The~     aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to~     a patient, who will only have a modest benefit from this compound. Prior to randomization for~     chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to~     identify patients who should not receive chemotherapy.~      Secondary objectives of this trial will be to compare overall survival and toxicity between~     the two chemotherapy arms, to evaluate survival in the observation arm and to perform~     translational research regarding prognostic and predictive factors.~   "
192135|NCT01049412|"~     Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new~     basal insulin analog and when they take insulin glargine~   "
192136|NCT01049399|"~     The purpose of this study is to determine wether NP031112 is safe and effective in the~     treatment of mild to moderate Progressive Supranuclear Palsy~   "
192164|NCT01049035|"~     The purpose of this study is to evaluate the optimal vaccination schedule for a Quadrivalent~     Meningococcal (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in order to~     provide an effective protein conjugate quadrivalent meningococcal vaccine in the population~     with the highest incidence of disease.~      Objectives:~        -  To describe the safety profile of TetraMen-T vaccine administered at 5 different~          schedules and concomitantly with routine pediatric vaccinations.~        -  To describe the immunogenicity profile of TetraMen-T vaccine administered at 5 different~          schedules and concomitantly with routine pediatric vaccinations.~        -  To describe the immunogenicity profiles of selected licensed pediatric vaccines~          (Pentacel, Prevnar, M-M-RII and Varivax) when administered either concomitantly with or~          without TetraMen-T vaccine.~   "
192263|NCT01047748|"~     The purpose of our study is to determine the optimum route for the injection of digoxin prior~     to second-trimester surgical abortion.~   "
192137|NCT01049386|"~     Rationale: Intestinal permeability of subjects can vary depending on their health status. It~     is therefore important to be able to measure and quantify intestinal permeability in a~     standardized way. Subjects with intestinal complaints (like irritable bowel disorder) or~     obese subjects have been found to have increased intestinal permeability. Different~     physiological conditions might affect intestinal permeability (IP) further.~      In the clinic, sugar absorption tests and different blood and urine markers have been used to~     quantify IP. The sugars sucrose, mannitol, sucralose and lactulose are absorbed differently~     in the small or large intestines, resulting in different sugar levels in urine. This~     indicates the level of intestinal permeability and the location of increased permeability~     which is more or less permeable.~      A high-fat meal could be used as a challenge test to increase IP in subjects even further.~     After a high fat meal, lipopolysaccharide (LPS) could be co-transported with chylomicrons.~     Small amounts of LPS co-transit with dietary fat from the gut after a high-fat meal, which~     thereby increases plasma LPS concentrations.~      Because of the above mentioned reasons, it could be relevant to determine intestinal~     permeability and plasma LPS concentration after consumption of a high-fat diet.~      Different methods will be used to determine the intestinal permeability in lean and obese~     men, under different conditions. New parameters, like intestinal (I) fatty acid binding~     protein (I-FABP), liver (L)-FABP, LPS and inflammatory markers will be measured and related~     to outcomes of tests, to examine the relation with intestinal permeability.~      The association of IP with whole body electrical resistance will be examined, to determine~     usefulness of a candidate non-invasive method for IP investigation.~   "
192138|NCT01049373|"~     To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back~     pain in relation to pain, functional impairment, quality of life, and state of health during~     a 15-week treatment period.~   "
192139|NCT01049360|"~     The purpose of this study is to evaluate the efficacy of this multicenter, randomized,~     double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study~     comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or~     with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID)~     in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD)~     beginning with a 2-week run-in period and with a 7-10 day washout each between treatment~     period.~   "
192140|NCT01049347|"~     Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol~     sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately~     to severely depressed patients. Additionally, serum and plasma are sampled during the 5-week~     study period in order to study endocrine and metabolic parameters.~   "
192141|NCT01049334|"~     The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg~     lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen~     lozenge throughout the course of treating sore throat due to acute pharyngitis.~   "
192142|NCT01049321|"~     The investigators are not aware of any study regarding the effect of DASH eating pattern on~     different cardiovascular risks among type 2 diabetic patients. The investigators assumed that~     DASH eating pattern could reduce the cardio-metabolic risks and improve the hepatic function~     among type 2 diabetes.~   "
192143|NCT01049308|"~     We assessed the prevalence of cognitive/memory problems in veteran patients with heart~     failure, and evaluated its relationship to medication compliance.~   "
192144|NCT01049295|"~     The aim of this study is to assess the effects of n-3 fatty acids on taxane-induced~     neuropathy and neurotoxic inflammatory agents in patients suffering from invasive breast~     cancer.~   "
192145|NCT01049282|"~     The study has the following objectives:~      Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine~     administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective~     To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in~     different antigen/adjuvant formulations at 0 and 2 months.~   "
192146|NCT01049269|"~     The objective of this study is to validate a portable 3D human body measurement system which~     will improve approaches in obesity assessment.~   "
192147|NCT01049256|"~     We aim to test our method for measuring chemosensitivity (the ventilatory response to a~     change in carbon dioxide), which uses sinusoidal carbon dioxide stimuli.~      Hypotheses:~        -  Carbon dioxide sensitivity is dependent on the cycle time over which we administer the~          gas (frequency).~        -  Chemoreflex gain decreases as deadspace increases.~   "
192148|NCT01049243|"~     The purpose of this research study is to better understand how fluocinonide cream 0.1%~     (Vanos®) works when people use it to treat atopic dermatitis for just a few days.~   "
192149|NCT01049230|"~     The purpose of this research study is to determine if radiation using proton beam therapy~     will kill the germ cell tumor in the participant's central nervous system. This type of~     radiation has been used previously on many patients with different types of cancers. There~     are two types of external radiation treatments, proton beam and photon beam. In this study we~     will be examining the effects of proton beam radiation therapy. Studies have suggested that~     this kind of radiation can spare normal tissue more than photon radiation therapy. The~     physical characteristics of proton beam radiation let the doctor safely increase the amount~     of radiation delivered to the tumor. We believe that proton beam therapy will potentially~     reduce side effects that participants would normally experience with photon radiation~     therapy.~   "
192150|NCT01049217|"~     The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in~     reducing neuropathic pain associated with HIV neuropathy.~   "
192151|NCT01049204|"~     Impact of Maraviroc, a ART CCR5 inhibitor, on the intensification of immune function in HIV-1~     infected subjects receiving immunisation with novel antigens~      The purpose of the study is to investigate the impact of adding Maraviroc (an anti-HIV agent)~     to a participant's normal HIV medication, on immune function. As part of the study~     participants will also receive three different vaccinations and a skin test. The study will~     also look at whether Maraviroc influences the body's response to these.~      The vaccines are given to stimulate the body's immune system, so we can therefore evaluate~     the impact that Maraviroc has on this.~      The duration of the study will be just over 24 weeks plus a screening period up to 4 weeks~     prior to the start of the study.~   "
192152|NCT01049191|"~     Osteoporosis is a common disorder of compromised bone strength causing 40-50% of women and~     ~25% of men to sustain fragility fractures during their lifetime. The reduction of bone~     strength in osteoporotic people results from loss of bone density and deterioration of bone~     quality. Bone quality is a complex amalgamation including macro- and micro-architecture,~     mineralization, turnover and damage accumulation. Currently, medications to reduce fracture~     risk are prescribed primarily on the basis of bone mineral density (BMD) measurement.~     Unfortunately, currently available BMD measurement technologies do not detect the~     aforementioned properties of bone quality; as such, less than half of individuals who sustain~     osteoporotic fractures are classified as osteoporotic by currently available diagnostic~     tools. Clearly, measures to enhance identification of those at high fracture risk are needed.~     High-resolution magnetic resonance imaging (HR-MRI) technology, such as that provided by~     MicroMRI, Inc., has outstanding potential to be such a tool. Therefore, our long-term goal is~     to evaluate and optimize the use of HR-MRI in fracture risk prediction; this pilot work is an~     essential step in attaining this goal.~      This research will investigate 72 postmenopausal women with normal or osteopenic BMD by~     dual-energy x-ray absorptiometry (DXA), 36 with prior low-trauma fractures will be compared~     with 36 age-, race- and BMD matched women without fracture. We hypothesize that 1.) Women~     with fractures will have evidence of microarchitectural deterioration on HR-MRI and 2.) Newly~     developed, more rapid MRI sequences designed at the UW will provide similar trabecular~     microstructure information more rapidly than the currently used, albeit investigational,~     technology produced by MicroMRI, Inc.~      Our specific aims are to a) Evaluate differences in MicroMRI parameters of trabecular~     microstructure (bone volume fraction, trabecular thickness, surface/curve ratio and erosion~     index) between age-, race- and BMD-matched postmenopausal women with and without fracture;~     b.) Correlate T2* relaxation time (a rapid indirect MRI measure of trabecular density and~     microstructure) with BMD measured by DXA, and microstructural parameters measured by~     MicroMRI. As an exploratory aim we will investigate HR-MRI parameters of trabecular~     microstructure obtained using a newly developed, rapid MRI sequence referred to as IDEAL-FSE~     with parameters obtained using the currently available MicroMRI, Inc. sequence.~   "
192153|NCT01049178|"~     The purpose of this study is to determine if intake of the antioxidant enzyme inducer,~     silymarin, will improve lung function and symptom scores in participants with asthma.~   "
192154|NCT01049165|"~     The primary purpose of this study is to evaluate the safety and tolerability of single oral~     doses of BMS-813160 in healthy subjects~   "
192155|NCT01049152|"~     Evaluation of different glycemic variations between the dialysis period and non-dialysis~     period in two groups: nondiabetic and diabetic patients undergone two different hemodialysis~     methods. Thirty-six patients, males and females, aged 50-80 years, with end stage renal~     disease (ESRD) will undergo hemodialysis and continuous glucose monitoring (CGM). The~     investigators will evaluate also inflammation markers before and after the different~     hemodialysis methods.~   "
192156|NCT01049139|"~     This study will carry out a preliminary proof of concept to evaluate two types of~     supplemental information that would serve as an adjunct to the traditional informed consent~     in a Human Immunodeficiency Virus (HIV) vaccine clinical trial. These will be compared to the~     condition where the traditional informed consent form is used alone.~      Using four intervention sites, participants will be administered a standard HIV vaccine trial~     consent form. They will then be randomized into three conditions: 1) No supplemental~     information; 2) Supplemental information with 1-sided messages (emphasizes information~     content related to vaccine trial randomization and unproven efficacy of vaccine); and 3)~     Supplemental information with 2-sided messages (acknowledges the beliefs that are at odds~     with the information content and seeks to neutralize those beliefs through counter-argument).~     An interviewer-administered questionnaire (IAQ) Part 1 will be administered before the~     traditional HIV vaccine trial informed consent is reviewed with the participant. An IAQ Part~     2 will be administered directly after the HIV vaccine trial informed consent in the control~     condition or after reading through the supplemental material. Debriefing interviews will be~     conducted with selected participants to review their understanding of the study procedures~     and their reactions to the supplemental materials and/or questionnaires.~      The proposed research is a proof of concept study and is therefore not designed to test~     hypotheses. Consequently, formal hypothesis and related power calculations to detect certain~     effect sizes are not required. Instead, the goal will be to enroll an appropriate number of~     subjects for purpose of determining the feasibility of developing a larger study of~     supplemental information to be used as an adjunct to the informed consent statement in HIV~     vaccine clinical trials and providing related descriptive statistics.~   "
192157|NCT01049126|"~     The purpose of this study is to assess the relationship of assay sensitive patients versus~     assay resistant patients with progression free survival.~   "
192158|NCT01049113|"~     This is an open-label, dose-escalation Phase 1 study of the investigational agent, ON 013105.~     In laboratory animal studies, ON 013105 has demonstrated anti-cancer activity. The purpose of~     this study is to determine the highest dose of ON 013105 that can be given safely in patients~     with relapsed/refractory Lymphoma or B-cell Acute Lymphocytic Leukemia (Philadelphia~     chromosome negative). Patients will receive weekly 2-hour IV infusions of ON 013105 at higher~     and higher doses until intolerable side effects are observed. It is important to know the~     highest safe dose so additional studies can be done.~   "
192159|NCT01049100|"~     The aim of this study is to determine whether the modified therapy on the basis of operative~     staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical~     cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a~     significant improvement of disease-free survival.~   "
192160|NCT01049087|"~     The purpose of the present study is to compare plasma volume determination by 99mTc-labeled~     albumin with 125I-labeled albumin. Fifteen subjects will be enrolled. The hypothesis is that~     plasma volume determined by the different methods are the same.~   "
192161|NCT01049074|"~     Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat~     nonspecific low back pain.~   "
192162|NCT01049061|"~     MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha~     expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate~     dose-limiting toxicity and estimate maximum tolerated dose.~   "
192163|NCT01049048|"~     In the United States, cardiovascular disease causes over one-third of all deaths and vitamin~     D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status~     adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D~     deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction.~     Moreover, we hypothesize that vitamin D supplementation will restore endothelial function,~     thereby reducing cardiovascular disease risk.~      This pilot research will be conducted in 64 post-menopausal women participating in an~     existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the~     others matching placebo) and will explore the effects of vitamin D on endothelial function~     and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their~     highest risk for development of a subsequent new cardiovascular disease diagnosis. All study~     participants will have fasting laboratory and noninvasive vascular ultrasound studies~     performed at baseline and four months later. The primary outcome measure of this pilot study~     is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.~     If our hypotheses are correct, our long-term goals include investigation of the effect of~     vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.~   "
192200|NCT01048567|"~     The purpose of this study is to determine whether Lactobacillus acidophilus/rhamnosus complex~     is effective in the prevention of antibiotic-associated diarrhea (AAD) in the elderly.~   "
192165|NCT01049022|"~     The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to~     see what the best dose should be for children in the future. Pharmacokinetics is to see how~     the body absorbs, distributes, breaks down and gets rid of the study drug. The~     pharmacokinetics of certain drugs may be altered in children due to developmental differences~     in various organ functions responsible for drug elimination, as well as in general~     distribution characteristics. The safety of moxifloxacin in children with infections will~     also be looked at. Results from this study will be used to guide dosing strategies of the~     larger clinical trial planned for children~   "
192166|NCT01049009|"~     High blood pressure (hypertension) is called the silent killer because many people do not~     know they have it, and do not know when it is well controlled. Unfortunately, over time~     uncontrolled hypertension can cause irreversible organ damage that can lead to heart attack,~     stroke, heart failure, and kidney failure. If a person cannot control their blood pressure~     with diet and exercise, doctors often prescribe medications to help control the blood~     pressure. Nebivolol is a medication that has been recently approved by the FDA for the~     treatment of hypertension. Our study will investigate whether treatment with nebivolol, as~     compared to another medication called metoprolol, in African Americans with hypertension will~     be more effective in protecting blood vessels against the harmful effects of high blood~     pressure.~      Over time high blood pressure causes hardening of the arteries (atherosclerosis) which leads~     to narrowing of the blood vessels and reduces blood flow to our organs. Arteries also relax~     and contract naturally, which further changes the blood supply. When arteries are narrowed,~     exercise can bring on a condition in which the blood supply is inadequate, and this might~     result in the sensation of pain.~      Cells lining our blood vessels produce a variety of substances that normally cause arteries~     to relax. Two of these substances are called nitric oxide (NO) and endothelium-derived~     hyperpolarizing factor (EDHF). We are trying to determine the nature of these substances in~     African Americans with high blood pressure and how it is affected by nebivolol and~     metoprolol. One way to determine this is to inject drugs such as L-NMMA~     (N(G)-monomethyl-L-arginine) or TEA (tetraethylammonium chloride), which block the production~     of NO and EDHF respectively, and then study what happens to the blood flow at rest and during~     exercise. It is our thought that nebivolol, in comparison to metoprolol, will increase the~     substances that naturally cause arteries to relax and improve blood supply.~   "
192167|NCT01048996|"~     Acute Lung Injury (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS) are a~     significant problem in Pediatric Intensive Care Units, affecting up to 16 of every 1000~     children admitted to these units. These disorders carry with them high mortality rates as~     well as numerous long-term effects for the surviving children. As the effects of these~     diseases have significant social and economic ramifications for affected children and their~     families, research on the development of ALI/ARDS could significantly change how physicians~     understand the disease and treat patients.~      There are a wide range of problems which make certain PICU patients more likely to develop~     either ALI or ARDS. This research aims to determine which of these children are at the~     greatest risk for ALI/ARDS by examining differences in plasma biomarkers and in DNA of a~     large number of PICU patients. We are hypothesizing that significant differences in the level~     of specific plasma biomarkers or in the frequency of specific DNA variants exist in children~     who develop ALI/ARDS.~   "
192168|NCT01048983|"~     The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, and~     minocycline when given alone or in combination to learn which is better for controlling~     symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.~   "
192169|NCT01048970|"~     Background: A frequent manifestation of advanced lung cancer is malnutrition, timely~     identification and treatment of which can lead to improved patient quality of life, response~     rate to chemotherapy and survival. N-3 fatty acids, especially eicosapentaenoic acid (EPA)~     and docosahexaenoic acid (DHA), may possess anticachectic properties. This trial compared a~     protein and energy dense supplement enriched with n-3 fatty acids with nutritional assessment~     for their effects on weight, lean body mass (LBM), body fat, phase angle, dietary intake,~     inflammatory response and quality of life in first-line chemotherapy patients with advanced~     lung cancer.~      Methods: Chemonaive patients with stages IIIB and IV of lung cancer are going to receive~     Paclitaxel and Cisplatin. Patients will be randomized to receive two cans/day of EPA and DHA~     containing oral supplement or nutritional assessment one week prior to treatment until~     completing two cycles. Serum levels of Reactive C Protein (RCP), interleukin-6 (IL-6) and~     tumor necrosis factor alpha (TNF-alpha) are going to be measured baseline and after two~     courses of chemotherapy. Phase angle and body composition will be measured using Bioimpedance~     analysis (BIA). Quality of life, dietary intake will be assessed with validate~     questionnaires. All data is going to be collected in a database for further blind analysis.~     Written informed consent will be collected from all patients.~   "
192170|NCT01048957|"~     Background:~      - One kind of drug craving, known as cue-elicited craving, occurs when a drug user who sees a~     drug-related cue (such as an image of someone using the drug) begins to feel a craving for~     the drug. Researchers are interested in studying how cue-elicited craving affects brain~     activity using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG)~     data.~      Objectives:~      - To determine which parts of the brain are associated with or involved in controlling~     cue-related craving in smokers.~      Eligibility:~      - Individuals between 18 and 50 years of age who are current smokers (10 or more cigarettes~     per day) and agree to try to abstain from smoking for 1 week during the experiment.~      Design:~        -  Participants will visit a clinical center for up to four scanning sessions, and will be~          asked to perform two or three outpatient tasks at home over the course of the study.~        -  Scan 1: Training session with a mock fMRI scanner, followed by an actual fMRI scanning~          session and EEG in which participants respond to pictures.~        -  Outpatient Task 1: Tolerance test with nicotine patch (worn for 8 hours, followed by 12~          additional hours without cigarette use).~        -  Scans 2 and 3: Training session and fMRI scan and testing with either nicotine patch or~          placebo. Tasks in fMRI involve looking at cues, reporting craving and suppressing~          craving.~        -  Outpatient Task 2: Participants will keep an electronic diary for 10 to 14 days,~          responding to questions as directed by the researchers.~        -  Scans 4 and 5: Training session, fMRI scan and EEG, and testing in which participants~          will be instructed on methods to attempt to control cravings.~        -  Outpatient Task 3: Participants will keep an electronic diary for 14 days. For the first~          7 days, participants will be asked to attempt to abstain from nicotine; participants may~          smoke normally on the second 7 days.~        -  Participants will be contacted 1, 3, 6, and 12 months after the end of the study for~          follow-up questions on current smoking habits.~   "
192171|NCT01048944|"~     The purpose of this study is to better characterize differences in mood, attention, brain~     activation patterns underlying the beneficial effects of pharmacological treatments~     previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers~     will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2)~     nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week~     intensive post-treatment follow-up. In addition, 20 percent of the subjects will be~     randomized to a delayed-quit control group.~   "
192201|NCT01048554|"~     This research is being done because melanoma in the brain is very difficult to treat because~     it does not respond to radiation or to chemotherapy, such as temozolomide. One of the reasons~     for this is that the melanoma can make chemicals that signal the brain to provide new blood~     vessels for the tumor. The main signal is called VEGF. Bevacizumab is an antibody that blocks~     VEGF. The investigators want to see if the combination of bevacizumab and temozolomide will~     stop the melanoma from growing.~   "
192172|NCT01048931|"~     Minimally invasive surgery has become the standard treatment for many gynecologic disease~     processes. In the last decade, numerous studies have demonstrated that laparoscopic~     approaches to various gynecologic oncology conditions-particularly for early-stage~     endometrial and cervical cancers as well as select pelvic masses-is feasible and results in~     shorter hospital stays, improved quality of life and comparable surgical and oncologic~     outcomes to abdominal staging [1-5].For instance, the typical gynecologic robotic surgical~     procedure will require Two to three 5-mm ports and one 12-mm laparoscopic ports. Recently, an~     even less invasive alternative to conventional laparoscopy surgery has been developed:~     laparoendoscopic single-site surgery (LESS), also known as single-port surgery. Single port~     laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive~     surgery while minimizing the potential morbidity associated with multiple incisions. However,~     to our knowledge, there are no randomize control trial to evaluate of single port or multiple~     ports laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess~     the feasibility of SPA-LAVH in the treatment of benign uterine disease.~   "
192173|NCT01048918|"~     The purpose of this study is to identify tumor cells in the bloodstream (Circulating Tumor~     Cells, CTC's) from patient's with locally advanced or metastatic (stage IV) breast cancer.~     Analyzing the tumor is helpful in guiding therapy; however, research has suggested that the~     number of tumor cells found in the bloodstream (CTC's) signifies more aggressive behavior and~     increased difficulty in eliminating the cancer. This research will help to develop better~     ways to treat breast cancer which could be tailored to a patient and may be adjusted to a~     patient's individual needs.~   "
192174|NCT01048905|"~     The primary hypothesis of this study is that glutamine supplementation will improve the~     erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and~     pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with~     PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography >~     2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and~     subsequently alter sickle red cell endothelial interaction that can be identified using~     endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological~     markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will~     decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced~     arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine~     bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD~     and Thal.~   "
192175|NCT01048892|"~     RATIONALE: Seneca Valley virus-001 may be able to kill certain kinds of tumor cells without~     damaging normal cells. Adding low dose cyclophosphamide (in part B of study) may help to kill~     even more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of Seneca Valley~     virus-001 in treating young patients with relapsed or refractory neuroblastoma,~     rhabdomyosarcoma, or rare tumors with neuroendocrine features.~   "
192176|NCT01048879|"~     Critically ill patients with flu may receive a drug called oseltamivir. They may also receive~     medical therapies to support their lung function (extracorporeal membrane oxygenation; ECMO)~     and kidney function (continuous venovenous hemodialysis; CVVHD). CVVHD and ECMO may remove~     some oseltamivir from the bloodstream. The purpose of this study is to determine how much~     oseltamivir gets removed by CVVHD or ECMO in critically ill patients.~   "
192177|NCT01048866|"~     The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg~     lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen~     lozenge throughout the course of treating sore throat due to acute pharyngitis.~   "
192178|NCT01048853|"~     The goal of this surgical research study is to learn if conservative surgery is a safe and~     feasible option for women with low-risk cervical cancer (stage IA2 or IB1, Grade 1 or 2).~   "
192179|NCT01048840|"~     The goal of this project is to determine the long-term health outcome of children diagnosed~     with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in~     the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have~     compiled a database of more than 200 subjects that completed diagnostic testing for GER in~     the 1970's and 1980's. Subjects are being contacted initially by mail using a previously~     approved recruitment letter. Subjects that fail to respond to this recruitment letter are~     called by phone. In each case, contact information has been abstracted from the Children's~     Hospital database. Subjects are then given the opportunity to complete a questionnaire either~     by phone or in hard copy. Subjects receive no compensation for their participation in this~     study. Subjects will be compared to controls. Controls will complete the same questionnaire~     as the subjects. Inclusion of potential controls will be determined by a lack of medical~     history of gastroenterological diseases before the age of 21 and whether the potential~     control was born within a year of a subject in the study. Controls will receive $25 to~     participate in the study.~   "
192180|NCT01048827|"~     Busulfan and etoposide have been used as preparative therapy for autoSCT (stem cell~     transplant) in adults with acute myeloid leukemia (AML) at UCSF for the past 10 years. Over~     this period and together with collaborative transplant centers, over 200 patients have~     received this treatment. By intent-to-treat analysis, and with median follow-up of 7.0 years,~     the 5-year DFS is 55%. The current protocol will utilize the combination of IV Busulfan (BU)~     and etoposide. The busulfan dose will be escalated amongst 3 targeted dose levels. All~     targeted dose levels represent higher busulfan dosing than standard myeloablative dosing,~     with the lowest dose being approximately 14% higher than standard. Busulfan levels will be~     monitored after the first, fourth and twelfth doses. Dose adjustments will be made in real~     time based on AUC levels determined from the first and fourth doses. This strategy of~     busulfan monitoring and dose adjustment has improved the therapeutic widow of BU in previous~     clinical trials.~      The current protocol will utilize the combination of intravenous busulfan and etoposide. The~     busulfan dose will be escalated amongst 3 targeted dose levels (area under the curve (AUC)~     levels at time 6 hours of 1250 uMol*min, 1400 uMol*min and 1550 uMol*min). All targeted dose~     levels represent higher busulfan dosing than standard myeloablative dosing with the lowest~     dose (1250 uMol*min) being approximately 14% higher than standard. In the absence of~     dose-limiting toxicity, cohorts of 4-6 patients will be treated at each dose level and 10~     additional patients will be treated at the maximum tolerated dose (MTD) to confirm safety.~     The busulfan dosing will begin at 1 mg/kg based on historical plasma levels obtained from~     patients receiving BU at a starting dose of 0.8 mg/kg at UCSF Medical Center.~      The highest dose level proposed for this study will exceed the reported toxic level for~     busulfan in the alloSCT setting. Patients will be followed closely for toxicity and strict~     stopping rules have been included. Eligibility criteria will exclude patients with prior~     history of hepatotoxicity or viral hepatitis. Potential hepatotoxic agents will not be~     allowed just prior to and during the busulfan dosing period. In addition, patients who~     experience hepatotoxicty during pre-transplant mobilization therapy may be excluded from~     receiving dose-escalated busulfan therapy. Every attempt will be made to prevent or avoid~     hepatotoxicity.~   "
192181|NCT01048814|"~     The purpose of this study is to improve upon and validate the prognostic and/or predictive~     accuracy of a drug response marker by the development of improved alternative algorithms~     based on the actual clinical outcome of retrospective cases.~   "
192182|NCT01048801|"~     Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor~     access to health facilities, home management of malaria (HMM) can improve the timeliness of~     treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and~     impact, ACTs should be deployed in HMM programmes, as well as in formal health facilities. Up~     to 80% of malaria cases are treated outside the formal health sector and shops are frequently~     visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs~     in Africa thus also need to examine the role of shops in home management and to ensure that~     drugs sold are appropriate. The current practice of presumptive treatment of any febrile~     illness as malaria (both at health facilities and in the context of HMM) based solely on~     clinical symptoms without routine laboratory confirmation, results in significant over-use of~     antimalarial drugs. With ACT being a more costly regimen, it is important to be more~     restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of~     confirming malaria diagnosis in remote locations lacking electricity and qualified health~     staff.~      This study therefore proposes to evaluate the feasibility, acceptability, and~     cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by~     community-based drug distributors.The accuracy of RDTs, and the acceptability of this~     approach, will be evaluated in both low and high transmission areas.~   "
192183|NCT01048788|"~     OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with~     ascites despite having received conventional diuretic therapy. Based on the change in body~     weight, on Day 7 it will be decided whether to continue administration at the same dose or to~     increase the dose, and then OPC-41061 will be orally administered for an additional 7 days at~     either 7.5 mg/day or, if diuretic effect for the initial 7-day administration is~     insufficient, at an increased dose of 15 mg/day. Plasma drug level, efficacy, and safety of~     OPC-41061 by 14-day repeated administration will be investigated.~   "
192184|NCT01048775|"~     The bispectral index (BIS) is derived from a single-channel electroencephalogram (EEG) and~     provides information on the anaesthetic depth. Recently, a bilateral two-channel EEG-sensor~     has been introduced to monitor the BIS on both cerebral hemispheres. In some patients~     significant left-right differences may occur, whereas no relevant side differences are~     expected in the majority of patients.~      The aim of this study is to~        -  investigate the incidence, duration and degree of left-right BIS differences~        -  examine the relation between BIS differences and occurrence of cognitive deficits~   "
192185|NCT01048762|"~     The purpose of this investigation is to determine the effects of exercise training on quality~     of life and physical capacity, 3 months and 1 year after radical operation for pulmonary~     cancer.~   "
192186|NCT01048749|"~     The purpose of this study is to test a physical therapy intervention for reducing pain in the~     low back and into the legs. With individuals over the age of 40 years, this pain may be~     associated to changes in back height from aging of the cushions between the back bones. When~     pain is caused from this, completion of different positions and rest periods have been shown~     to help reduce the pain, at least temporarily. This study will compare two such positions;~     1)floating in deep warm water with weights attached to the ankles, to take the load off of~     the spine, 2)lying on their back with hip and knees flexed to a 90 degree angle. The height~     of each person will be measured before and after completion of each intervention using a~     specially designed measuring tool.~      Experimental hypothesis:~        1. Subjects with low back and leg pain suggestive of nerve root compression syndrome will~          experience increase in spinal height when completing aquatic vertical suspension and/or~          land-based supine flexion.~        2. Subjects with low back and leg pain suggestive of nerve root compression syndrome will~          experience greater increase in height, greater reduction of pain intensity and location~          when completing underwater vertical suspension as compared to supine land based flexion.~   "
192187|NCT01048736|"~     Aging is associated with declines in aerobic capacity, exercise tolerance, and functional~     endurance that lead to physical disability and loss of independence. Furthermore, the~     existing high prevalence of obesity in the elderly is greatly exacerbating these~     aging-related declines in function. To date, regular exercise is the only known therapy to~     consistently improve aerobic function, and perhaps delay the onset of disability. Although~     aerobic exercise training does benefit both aerobic capacity and endurance even in obese~     persons, some data show that the maximal efficacy of exercise for improving aerobic function~     is blunted by obesity. In addition, our preliminary data show a potential dose-response~     benefit of concomitant fat loss on exercise-induced improvements in aerobic function. Thus,~     combining an exercise intervention with caloric restriction resulting in fat loss may be more~     efficacious for improving aerobic function than exercise alone in obese elderly, a population~     at high risk for disability. The purpose of this study is to determine whether the amount of~     fat loss (achieved through controlled underfeeding) affects the magnitude of improvement in~     aerobic function (maximal aerobic capacity and endurance) in response to a standardized~     exercise training stimulus that follows current recommendations for older persons.~   "
192188|NCT01048723|"~     The goal of this clinical research study is to learn if the study drug RAD001 can stop or~     slow the growth of resectable soft tissue sarcoma. The patient's physical state, their~     symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study~     will help the research team decide if RAD001 is safe and effective in patients with this~     condition. The study drug, RAD001, is made by Novartis Pharmaceuticals Corporation.~   "
192189|NCT01048710|"~     The primary objective of this prospective multicenter study is to assess whether the~     functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for~     patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated~     with open wedge high tibial osteotomy (HTO) using the TomoFix™ Small is better than the~     functional outcome after conservative treatment.~   "
192190|NCT01048697|"~     This study is designed to measure drug concentrations in the blood of healthy volunteers~     administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass~     index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner~     volunteers, and those with a BMI > 40 kg/m2 will have even greater clearance than those who~     are leaner.~   "
192310|NCT01047124|"~     The purpose of this study is determine whether a specialised mood disorder service, which~     offers tailored psychological and pharmacological treatment, is more effective in the~     treatment of chronic unipolar depressive disorder then treatment as usual.~   "
192191|NCT01048684|"~     Neuroanesthesia for supratentorial surgery involves a thorough understanding of the~     physiopathology of intracranial pressure, cerebral homeostasis and regulation of cerebral~     perfusion pressure as well as the effects of anesthesia and surgery on these elements.~      The main objective of anesthesia during neurosurgery is to preserve the integrity of the~     brain by maintaining cerebral homeostasis, and assuring cerebral protection using~     normovolemia, normotension, normoglycemia, moderate hyperoxia and hypocapnia and~     hyperosmolality with the administration of mannitol.~      During surgery, the use of surgical retractors must be limited to avoid possible ischemia of~     the brain tissue. Surgical retractors can be replaced by chemical retractors. The concept of~     chemical retraction involves a reduction of cerebral blood flow, maintaining cerebral~     perfusion pressure, moderate hyperventilation, drainage of cerebrospinal fluid and~     osmotherapy.~      Mannitol, an osmotic agent, has been widely used to reduce the volume of the brain, the~     intracranial pressure and to facilitate the surgical approach in reducing the risk of~     cortical lesions during the opening of the skull.~      Mannitol 20% is usually given intravenously in bolus doses of 0.5-1g/kg over 30 minutes.~     However, over the last few years, the concept of a dose-response relationship has emerged.~     Some recent studies tend to demonstrate that higher doses of mannitol could reduce~     intracranial pressure significantly without any important side effects.~      The main objective of the present study is to compare two doses of mannitol (0.7 and 1.4~     g/kg) on brain relaxation during supratentorial craniotomies.~   "
192192|NCT01048671|"~     To evaluate the management of HIV-1 participants treated with antiretroviral combination~     therapy including the integrase inhibitor raltegravir, all across the country of France.~   "
192193|NCT01048658|"~     Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second~     trimester abortion procedures. It has a few advantages, including ease of use by the~     anesthesia provider. However, the literature suggests that when used in doses higher than~     those used at Oregon Health & Science University (OHSU) and Lovejoy, it is associated with an~     increase in the risk of bleeding. The investigators study aims to test whether the lower dose~     used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in~     blood loss, when compared to similar abortion procedures for which this drug is not used.~   "
192194|NCT01048645|"~     Purpose:~      This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel~     plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free~     survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an~     acceptable toxicity profile and its association with the expression of Retinoic acid receptor~     beta 2 (RAR-beta2) as a response biomarker.~      Patients and Methods:~      Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC).~     Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior~     to treatment until completing two cycles. RAR-beta2 expression was analyzed by~     Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.~   "
192195|NCT01048632|"~     Oxandrolone is an anabolic steroid, marketed in the United States as an adjunctive therapy to~     combat weight loss resulting from chronic infection, extensive surgery, severe trauma,~     protein catabolism associated with prolonged administration of corticosteroids, and for the~     relief of bone pain accompanying osteoporosis. In children, it has been used to prevent and~     treat growth failure associated with severe burns (≥ 40% of total body surface area),~     Duchenne muscular dystrophy, Turner's syndrome, constitutional delay of growth and puberty,~     and chronic wasting in HIV-positive pediatric patients. Other applications in children have~     included treatment of central idiopathic precocious puberty, hereditary angioedema, and~     bilateral congenital anorchia. Growth failure is a common feature of infants with complex~     congenital heart disease, and can adversely affect outcome. This therapy has not been~     previously implemented in neonates thus we will evaluate the safety and efficacy of~     administering oxandrolone to improve growth in neonates with complex congenital heart disease~     who have undergone surgical palliation or repair by collecting anthropometric measurements~     and pharmacokinetic data.~      Neonates with HLHS or variant with planned Norwood Procedure. The primary aims of this pilot~     study are to assess safety and efficacy of oxandrolone in this population. Our goal will be~     to enroll 5 patients in each phase of this pilot study. The incidence of adverse events will~     also be monitored and compared to untreated patients. Enrollment will continue until the~     target of 20 total patients has been met.~   "
192196|NCT01048619|"~     In other clinical studies, ON 01910.Na has been safely given intravenously to Patients with~     advanced cancers. However, to treat some Patients, it may be better if ON 01910.Na could be~     given by mouth. This study will determine if it is safe to give ON 01910.Na by mouth, what is~     the highest dose can be safely given by mouth, and how much of the drug gets from the stomach~     into the blood stream when it is given by mouth.~   "
192197|NCT01048606|"~     Menopause is characterized by a decrease of estrogen and progesterone levels and is~     associated with various changes in body composition, including an accumulation of total fat~     mass, a relocation of adiposity to the abdomen, deterioration of plasma lipid profile,~     increased risk of type 2 diabetes, and increased oxidative stress. Taken together, these~     changes increase the risk of developing cardiovascular disease (CVD).~      Physical activity and hormone-replacement therapy (HRT) have been shown to act in synergy to~     improve total fat mass in postmenopausal (PM) women. Because the progesterone component of~     HRT has been associated with an increased CVD risk in older women with a family history of~     CVD, the use of HRT has become controversial. As a result, a large decrease of the use of HRT~     in the community has been observed and postmenopausal women (PM) have developed interest in~     alternative therapies. Among the possibilities, phytoestrogens have shown beneficial effects~     on menopausal symptoms and plasma lipids. Phytoestrogens are structurally and functionally~     similar to estradiol (the major estrogen in humans) but found only in plants such as soybean~     isoflavones. They do not exert any effect on breast cancer or/and endometrial tissue.~      AIMS To examine the effects of phytoestrogens, exercise and the combination of both on lean~     body mass, total fat mass, visceral fat, blood lipid profile, oxidative stress markers,~     antioxidant system, glucose metabolism, and sex-hormone levels in obese PM women.~      HYPOTHESES Women undergoing a combination of phytoestrogen treatment and an exercise program~     will display a greater increase in lean body mass, decrease in total and visceral fat mass,~     improvements in blood lipid profile, decrease in oxidative stress markers, increase in~     antioxidant system, improvement in glucose metabolism, and increase in sex-hormone levels~     than those submitted to any or one of the treatments.~      A total of 120 women will be recruited. There will be 4 groups (30 women/group) undergoing~     exercise or not and supplemented with phytoestrogens or a placebo. The intervention is~     planned to last 12 mo. Key variables will be measured at baseline, and after 6 and 12 mo of~     intervention.~      Three weekly 1h-sessions of exercise will be held on 3 non-consecutive days. The~     phytoestrogen supplements will consist of 70 mg/d of soy isoflavones taken as 4 caps/day.~   "
192198|NCT01048593|"~     This study will test the efficacy and safety of IBI-10090 for the reduction of ocular~     inflammation after cataract surgery.~   "
192199|NCT01048580|"~     This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.~   "
192202|NCT01048541|"~     Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard~     minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a~     balloon. This length is defined by hospital standards although it is known that the male~     urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by~     Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There~     is a lack of clinical data documenting that male ICs that are shorter and more or less~     flexible than standard catheters can sufficiently empty the bladder of male subjects. This~     will be tested using ultrasound to measure residual urine in the bladder following~     catheterisation with new product and standard length catheter.~   "
192203|NCT01048528|"~     The study will examine the effects of a cognitive behavioral stress management (CBSM) group~     intervention on antibody and cellular immune function among women who are at elevated risk~     for breast cancer because of family history.~      Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and~     secondary antibody response to HA vaccine compared to women in the comparison group.~      Hypothesis 2: In response to stimulation with HA antigen, lymphocytes from women who~     participate in the CBSM intervention will have larger primary and secondary in-vitro~     proliferative response to HA antigen, and increased primary and secondary in-vitro TH1~     cytokine response to HA antigen compared to lymphocytes from women in the comparison group.~      Hypothesis 3: Women who participate in the 10-week CBSM group intervention will report lower~     levels of distress immediately after the intervention compared to women in the comparison~     group. Changes in distress as a result of the intervention will be associated with any~     significant changes in immune function discovered in Aims 1 and 2.~   "
192204|NCT01048515|"~     The study investigated the effect of caffeine on physical performance in healthy citizens~     aged over 70 years following eight hours of abstinence from caffeine containing drinks and~     foods. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65%~     of expected maximal heart rate.~   "
192205|NCT01048502|"~     The purpose of this study is to better understand the anti-inflammatory benefits of two~     prescription medicines that are currently used to help people with cholesterol problems.~      Fish oil, from eating certain kinds of fish and from supplement pills, has been used to help~     control cholesterol and reduce inflammation (the body's response to injury or sickness).~     Lovaza® is the brand name for prescription strength fish oil pills. In this study, we will be~     looking at how Lovaza® works to help reduce inflammation in healthy volunteers.~      Tricor® is the brand name for prescription fenofibrate pills. Fenofibrate is a prescription~     medicine that many doctors give to people with high triglyceride (fat in the blood) levels.~     In this study, we will be looking at how Tricor® works to help reduce inflammation in healthy~     volunteers.~      Endotoxin or lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living)~     that can cause many of the effects similar to bacterial infections in humans. However, it can~     be administered in very small amounts to produce a mild immune response much the same as a~     'flu' like illness. Within 1 ½ -3 hours after giving LPS by vein, a response consisting of~     fever, chills, headache, nausea and vomiting and generalized aches and pains will occur which~     lasts up to 6-8 hours. In addition to the flu like symptoms, the response causes temporary~     changes in cholesterol, triglycerides and blood sugar. Different people respond differently~     to LPS. We are using LPS in this study to bring on a temporary inflammatory response in the~     body and to compare the responses of people who receive Lovaza® or Tricor® to the responses~     of people who receive a placebo (pill that does not contain medicine).~   "
192206|NCT01048489|"~     Effectiveness of health education regarding the smoking habit is under discussion .~     Nevertheless, according to the literature, some personal, familiar, cultural, and social~     factors are considered risk factors for students to become smokers. Probably, a health~     education intervention integrated in the school program will show a higher rate of~     effectiveness regarding incidence and prevalence of smoking habit in this age-group .~      OBJECTIVE: To evaluate the effectiveness of a health education program to reduce the smoking~     habit in students.~      METHODOLOGY: Quasi-experimental design including all the junior high school students in an~     educational district in Tarragona (Spain). The sampled schools will be randomised into two~     groups (experimental and control). All the included students will be monitored for three~     years.~      The health education program will be divided in three interventions: role games and debates~     (1st year), workshops regarding the family and the social role of smoking (2nd year) , and~     the analysis of smoking advertising (3rd year). The incidence and prevalence rates will be~     compared on the experimental and control group, before de beginning of the intervention and~     at the beginning of each year.~   "
192207|NCT01048476|"~     Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased~     interest in evaluating the effect of lutein for optimizing eye health. A large number of~     epidemiological studies support the notion that the high intake dietary of lutein is strongly~     associated with a decreased relative risk of AMD.Moreover, findings from initial~     observational studies have now been followed by placebo-controlled intervention trials~     showing that dietary modification and supplementation with lutein result in increasing the~     macular pigment optical density, and may help to improve visual function in patients~     suffering from AMD.Currently, nutritional status and background information of lutein and~     zeaxanthin in Chinese population is lack. Little is known about the preventive and therapy~     benefits of lutein on visual function in the AMD populations. In particular, the effect on~     visual function of relatively certain doses of lutein and zeaxanthin is unknown. Therefore,~     the objective of the present study was to examine the effect of consuming different doses of~     lutein on MPOD and visual function in AMD.~   "
192208|NCT01048463|"~     Malnutrition is frequently seen in patients on chemotherapy suffering from gastric/colorectal~     cancer and may worsen the outcome. EPA, a sort of ω-3 PUFA, can modulate immune system. EPA~     also antagonizes metabolic and inflammatory changes induced by the tumor. This study is to~     test whether EPA, in combination with enteral nutrition, can improve nutritional/immunologic~     status, quality of life, and reduce chemotherapy related side effects of these patients.~   "
192209|NCT01048450|"~     The purpose of this study is to examine the long-term outcomes for the surgical treatment of~     end stage degeneration in the big toe joint.~   "
192210|NCT01048437|"~     This study is a group-randomized controlled trial to explore whether improved community~     transplant education for renal patients not yet on dialysis could increase patients'~     willingness to pursue preemptive living donor transplant (PLDT) and PLDT rates.~   "
192211|NCT01048424|"~     Urgency incontinence is a common and burdensome problem in women. Current treatments for this~     condition, while effective, are associated with potentially disabling side effects and high~     rates of discontinuation. There is an urgent need for alternate treatments for urgency~     incontinence that are both clinically effective and well-tolerated by women in the community.~      RESPeRATE is a commercially available walkman-like device that measures chest/abdominal~     excursion during respiration using an elastic belt with a sensor placed around the torso over~     clothing. The device senses respiration and uses musical tones keyed to inhalation and~     exhalation to help the user slow respiration and prolong exhalation to a recommended goal of~     less than 10 breaths per minute. RESPeRATE is approved by the US Food and Drug Administration~     (FDA) for treatment of mild hypertension, and use of the device has also been shown to~     decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate. Because~     anxiety and stress are strongly associated with urgency incontinence, and common behavioral~     strategies for managing incontinence emphasize relaxation and slow breathing at the time of~     an urgency episode, paced respiration may also be useful in treating urgency incontinence~     and/or decreasing its burden on quality of life.~      We propose to conduct a 6-week pilot randomized controlled trial of slow paced respiration~     using the RESPeRATE device among 30 women with urgency incontinence to assess the feasibility~     of recruiting and teaching women to use the RESPeRATE device as well as to gather preliminary~     data on the efficacy of slow paced respiration for treatment of urgency incontinence and~     related symptoms. Participants will complete a 7-day voiding diary and complete~     questionnaires to measure outcome.~   "
192212|NCT01048411|"~     The homeopathic remedy 'naja-comp' will improve functional outcome measured by the~     Barthel-Index.~      The homeopathic remedy 'naja-comp' will decrease complications during geriatric~     rehabilitation measured by rate of unplanned discharge to hospital.~   "
192213|NCT01048398|"~     BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech~     presentation. The external version is a maneuver gynecological used to turn a breech in~     cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for~     fast action and elimination.~      OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external~     version.~      PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion~     criteria and sign the consent. Participants will be randomized into two groups before the~     procedure.~      Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo~     DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events.~      Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of~     adverse events~   "
192214|NCT01048385|"~     The goal of our research is to increase live birth rates in infertile women and to reduce the~     incidence of aneuploidy leading to miscarriage and trisomies. We hypothesize that an age~     related mitochondrial dysfunction reduces the availability of energy in the oocyte and~     contributes to abnormal segregation of chromosomes during the meiotic division leading to~     oocyte aneuploidy. Based on preliminary evidence we have obtained in aged mice, we propose~     that dietary supplementation with Co enzyme Q10 in older women will improve mitochondrial~     function in the oocytes, leading to a decrease in chromosomal non-disjunction and resulting~     in embryos with a normal chromosomal complement. Our primary outcome measure will be~     determination of oocyte chromosome number by multiplex PCR based assay of polar bodies~     biopsied at the time of IVF. Outcomes of this proposal will enable us to address the~     mechanisms of ovarian aging and may explain etiology of decreased fertility in older~     patients. In addition, our work will add to the feasibility of single embryo transfer,~     thereby avoiding multiple pregnancies and their associated cost to the health care system and~     to society.~   "
192215|NCT01048372|"~     Primary Objective: To determine the mechanism of Cytolin's effect on HIV replication from~     blood drawn from HIV-positive and HIV-negative individuals after exposure to Cytolin.~   "
192216|NCT01048359|"~     The primary purpose of the project entitled: Multidisciplinary Approach to Reduce Injury and~     Substance Abuse, which is funded by the National Institute on Drug Abuse (5R01DA026088-02),~     is to compare the effectiveness of brief intervention, brief intervention plus a booster, and~     brief advice for adult patients who abuse drugs and present to a trauma department for~     treatment of an injury.~   "
192217|NCT01048346|"~     Hypothesis 1. Consumers with disabilities and co-occurring SUD receiving IPS will be more~     likely to be competitively employed (defined as 1 or more days of work over the past 30 days)~     at 3, 6 and 12 months following the initiation of vocational treatment goals when compared to~     a group receiving standard services.~      Hypothesis 2. Consumers with disabilities and co-occurring SUD receiving IPS when compared to~     the comparison group will 1.) be more successful in achieving their employment goals as~     indicated by the ratio of hours worked to desired hours worked; 2.) become competitively~     employed sooner; 3.) earn higher wages, 4.) have greater job satisfaction, 5.) have greater~     economic satisfaction; 6.) have greater life satisfaction, 7.) have greater self-esteem, and~     8.) have fewer days of using substances during follow-up points.~   "
192218|NCT01048333|"~     -  Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single~          dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced~          Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.~        -  Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the~          FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1~          curve from 0 to 120 minutes)~   "
192219|NCT01048320|"~     The main research objective is to work out the optimal doses of the novel combination of~     gemcitabine, oxaliplatin and imatinib mesylate (glivec) in patients with advanced pancreatic~     cancer that has progressed during or after treatment with first-line gemcitabine.~   "
192220|NCT01048307|"~     Objective:~      To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment~     of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution~      Methodology:~      Randomised, controlled multi-centre, prospective clinical trial~      Planned number of subjects:~      20 patients in experimental group (Prontosan® Wound Irrigation Solution) 8 patients in~     control group (wound irrigation with saline)~      Products under investigation:~      Prontosan® Wound Irrigation Solution~      Study Duration:~      3-4 weeks~   "
192221|NCT01048294|"~     One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal~     Affective Disorder(SAD) or so called winterdepression is a disturbance of circadian rhythms.~     Since the circadian system is especially sensitive for the blue portion of the light~     spectrum, a new light therapy device with more blue light (blue enriched polychromatic light)~     was tested for its efficacy to treat SAD. In chronobiological terms this light is~     hypothesized to be more potent in inducing non-visual effects. In the present study~     fluorescent tubes that emit a high portion of short wavelength light on top of the normal~     wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour~     temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients.,~     The investigators hypothesise that blue- enriched light improve the therapeutic effects of~     light treatment leading to a higher response or the same response in a shorter time schedule~     compared to standard light treatment.~   "
192222|NCT01048281|"~     Our research of the biology of upper gastrointestinal cancers involves the study of tissue~     samples and cells from biopsies of persons with gastric or esophageal cancer or blood samples~     from upper gastrointestinal cancer patients and persons at high inherited risk for these~     cancers. We hope to learn the role genes and proteins play in the development of gastric and~     esophageal cancer.~   "
192223|NCT01048268|"~     The purpose of this study is to determine whether glucose-dependent insulinotropic~     polypeptide (GIP) has a stabilizing function on the blood glucose~   "
192224|NCT01048255|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of VX-765 in~     subjects with Treatment-resistant Partial Epilepsy~   "
192225|NCT01048242|"~     The objective of the study is to determine if treatment with Ramelteon will help to improve~     insomnia in older adults with co-existent insomnia and sleep apnea. The primary study~     objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will~     be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study~     objective is to determine if subject compliance with CPAP treatment of their sleep apnea is~     improved in subjects taking Ramelteon (their compliance may be improved because they would~     have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that~     compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo~     arm.~   "
192226|NCT01048229|"~     Title: Evaluation of the tolerance and acceptability of Rasagiline in the treatment of~     early-stage Parkinson's disease.~      Type of study: Phase IV~      Study objectives:~      Principal objective:~      To evaluate the tolerance and acceptability of Rasagiline versus Pramipexole (dopamine~     agonist).~      Secondary objectives: To evaluate the clinical benefits of Rasagiline administered as a~     monotherapy in patients presenting with early-stage Parkinson's disease.~      Study design:~      Multicentre comparative randomised parallel-group double-blind study, with a total duration~     of fifteen weeks (three weeks of dose titration and twelve weeks of follow-up), comprising~     four evaluations (D0, W3, W9, W15).~      Number of patients:~      240 patients (i.e. 120 in each group) presenting with early stage idiopathic Parkinson's~     disease.~      Number of centres:~      70 neurologists distributed throughout three French regions~      Treatment studied: Rasagiline Presentation: 1 mg tablets Dosage : 1 mg/day in a single dose,~     in the morning at breakfast-time.~      Comparator: Pramipexole Presentation: 0.125 mg, 0.25 mg and 1 mg pramipexole dihydrochloride~     monohydrate tablets (corresponding respectively to 0.088 mg, 0.18 mg and 0.7 mg of~     pramipexole)~      Dose-titration: As specified in the SPC for pramipexole, the product will be administered in~     three daily doses, preferably with meals, and the treatment will begin with a dose-titration~     phase of three weeks' duration, during which time the dosage will be gradually increased.~      On completion of the dose-titration phase, the minimum therapeutic dose of 1.5 mg per day~     must be achieved by all the patients. The patients who cannot achieve this dosage will be~     withdrawn from the study. The reason for stopping dose-titration (and leaving the study) will~     be detailed in the CRF.~      Dosage:~      The effective dosage of pramipexole should be adapted to the individual, depending on~     clinical response and tolerance, in successive stages of 0.75 mg at one-week intervals,~     without exceeding the maximum dose of 3 mg per day.~      Treatment prohibited during the study :~      Pethidine, fluoxetine, fluvoxamine, dextromethorphan, or any other MAOI, sympathomimetics~     (including nasal and oral decongestants containing ephedrine or pseudoephedrine), anti-H2s~     (cimetidine, ranitidine).~      Principal evaluation criterion :~      The principal criterion of evaluation is the percentage of patients who have presented with~     at least one  significant  adverse event during follow-up.~      A significant adverse event is defined as :~        -  a severe adverse event (SAE)~        -  an adverse event which in the opinion of the investigator requires suspension of the~          treatment or reduction in dosage~        -  an adverse event considered as severe or moderate by the patient (AEs of which the~          intensity has not been evaluated will be considered as moderate to severe)~      Secondary evaluation criteria:~        -  analysis of adverse events in the total population~        -  analysis of adverse events by degree of severity~        -  analysis of adverse events in subject over 65~        -  analysis of adverse events by symptom~        -  percentage of patients presenting with sleep problems (daytime drowsiness, narcolepsy,~          insomnia, fragmented sleep…)~        -  evaluation of Epworth Sleepiness Scale~        -  evaluation of quality of life (PDQ-8)~        -  evaluation of utilities by EuroQol (EQ-5D)~        -  overall clinical impression evaluated by the doctor (CGI-I) and by the patient (PGI-I)~        -  Global-Benefit-Risk (GBR)~        -  Evaluation of resources~      Analysis of the principal criterion:~      Analysis of the principal criterion will be carried out with those patients from the~     intention-to-treat population for whom tolerance data is available in at least one visit~     after D0.~      Comparative analysis The percentages of patients in the two treated groups who present with~     at least one significant adverse event will be compared using a Khi-2 test.~      Logistic regression A logistic regression analysis will be performed in order to explain the~     presence/absence of a significant event. The nature of the treatment and the centre will act~     as explanatory variables, and the initial scores as covariates. Analyses will also be~     performed on quantitative variables (ANCOVA)~      Evaluation of the Global Benefit-Risk (GBR) according to the model suggested by Chuang-Stein~     et al.~      Number of subject required:~      Calculation of the size is based on the hypothesis that the percentage of patients presenting~     with at least one significant adverse event during follow-up (principal evaluation criterion)~     will differ by 15% from one group to the other. With an alpha risk set at 5% and a beta ris~     kat 20%, the number of subjects required, calculated using the Casagrande et Pike formula, is~     110 subjects per group.~      The NSN was slightly overestimated in order to maintain the desired strength while taking~     into account the possibility of lost to follow-up, and was fixed at 240 patients.~   "
192227|NCT01048216|"~     This study is designed to treat tumors in the liver that cannot be removed surgically and~     chemotherapy cannot control these tumors, using radiation therapy and a more precise delivery~     than has been used before.~   "
192228|NCT01048203|"~     This is a single site, open label, single dose, non-randomized study in healthy male and~     female subjects. The subjects will be evaluated for plasma, urine and feces levels of~     14C-ABR-215050 during 21 days.~   "
192229|NCT01048190|"~     The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated~     Poliomyelitis Vaccine made from Sabin Strains by different does.~   "
192230|NCT01048177|"~     In order to investigate whether the pain in women with vulvodynia may represent bladder~     origin pain, we will be performing a diagnostic test for interstitial cystitis (IC) in women~     with generalized vulvodynia. Those women with a positive test for IC, we will be performing a~     series of bladder treatments (instillations) for IC and checking symptoms throughout the~     trial to see if significant relief of vulvar pain can be obtained through treatment for IC.~   "
192231|NCT01048164|"~     The purpose of this study is to evaluate the effect of therapeutic massage in alleviating~     musculoskeletal pain and discomfort associated with wearing lead aprons in the cardiac cath~     lab. We also want to evaluate if therapeutic massage will reduce fatigue, stress, and anxiety~     while improving the level of relaxation in cardiac cath lab employees who wear lead aprons.~   "
192232|NCT01048151|"~     While radiation therapy with androgen ablation (hormone reduction) is the standard method of~     treating locally advanced prostate cancer. New treatments are being combined with radiation~     therapy in an effort to further improve the cure rates.~      This study proposes to combine an experimental drug, TNFerade™ Biologic, (also called~     AdGVEGR.TNF.11D or TNFerade) at different dose (amounts) levels in combination with~     radiation.~      TNFerade™ Biologic is a form of gene transfer therapy that when injected into the tumor has~     shown to increase the effect of radiation therapy.~   "
192233|NCT01048138|"~     There is no AED or medication that has been demonstrated to affect the development of~     post-traumatic epilepsy. Biperiden is a cholinergic antagonist, acting in the muscarinic~     receptor, that is widely used as an anti Parkinson drug. The investigators data with animal~     models of epilepsy indicate that anti-muscarinic agents might affect the natural course of~     the disease in the case of post-traumatic epilepsy.~   "
192234|NCT01048125|"~     Stress (Takotsubo) cardiomyopathy (SC) is a peculiar form of acute, reversible myocardial~     dysfunction predominantly affecting the apical and mid left ventricular segments.~      In this institution over the last two to three years the investigators have identified more~     than a dozen patients with stress cardiomyopathy. The investigators' overarching goal is to~     characterize these individuals with the hope of identifying risk factors and developing~     strategies to prevent the occurrence of SC in situations where the likelihood in susceptible~     individuals may be high.~   "
192245|NCT01047982|"~     Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of~     living cells and is widespread in many food. It is involved in a number of biological~     processes, including insulin signal transduction, resulting in modulating insulin~     sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two~     hundred and twenty obese pregnant women will be included in the trial and, after an informed~     consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks~     gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at~     24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be~     registered.~   "
192246|NCT01047969|"~     An assessment of the safety of omission of surgery following a complete response to~     chemotherapy and radiotherapy, or radiotherapy alone, for rectal cancer.~   "
192247|NCT01047956|"~     Evaluation whether higher retention rate is in those of combined methadone with~     N-Acetyl-Cysteine compared to those with methadone alone during a six-month study.~   "
192248|NCT01047943|"~     The clinical assessment of patients with plaque-type psoriasis is performed by open,~     intrapatient comparison of 0.2% STA-21 with vehicle(Vaseline) alone within a 2 week period.~   "
192235|NCT01048112|"~     The goal of this research is to continue to develop a model of infection with Campylobacter~     jejuni, a bacterium that causes food and water-borne disease (mainly diarrhea). The~     objectives are to 1) determine if healthy subjects develop short-term (<6 month) protection~     to reinfection with C. jejuni; and 2) characterize the immune responses to C. jejuni~     infection. Information obtained will be used in development of a vaccine against~     Campylobacter infections.~      Volunteers will be screened for eligibility within 60 days prior to enrollment. Screening~     will include obtaining informed consent prior to any study procedure. This will be followed~     by medical history, physical examination, review of current medications, blood samples for~     safety labs (WBC, Hct, Hgb, platelet count; chemistry panel; screening for HIV, HLA-B27, HBV,~     and HCV); urine pregnancy testing for females. Stool will be tested for infection.~      Eligible volunteers will be enrolled in the study and admitted to the GCRC on Day -1. They~     will drink a measured dose of C. jejuni on Day 0, and followed for approximately 9 inpatient~     days, during which time the investigators expect at least 75% to develop a diarrheal illness,~     which will be promptly treated with replacement fluids (oral or IV, as indicated) and~     antibiotics. During the inpatient period, subjects will be assessed for any adverse events,~     and blood and stool specimens will be analyzed for markers of infection and markers of immune~     response. Subjects must have resolved or resolving symptoms and two negative stool cultures~     ≥12 hours apart to be eligible for discharge, and will be seen in outpatient follow-up at 21,~     28, 35, 60, and 90 days for additional AE assessments and blood and stool analysis.~      Eight subjects will return for redosing approximately 98 days after the initial dose, with~     the same inpatient and outpatient follow-up as above. Few or none should develop a diarrheal~     illness. Four naïve (previously unexposed) subjects will also receive the dose on Day 98 to~     confirm a 75% illness rate with this dose. They will be followed as the initial group was.~     All participants will be assessed by phone 6 months after the final dose they received.~   "
192236|NCT01048099|"~     This trial will evaluate the clinical significance of the PRO Onc assay and will assess the~     efficacy of HER2-targeted therapy in patients with HER2-negative breast cancer who have been~     identified as having HER2 overexpression/activation by the PRO Onc Assay.~   "
192237|NCT01048086|"~     This study is for patients with neuroblastoma or a neuroendocrine tumor who have not been~     able to have standard therapy or have failed the first-line therapy. The purpose of this~     study is to assess the safety and effectiveness of the combination of retinoic acid and~     Onalta (Y-90-DOTA-tyr3-Octreotide) in treating neuroblastoma and neuroendocrine tumors.~   "
192238|NCT01048073|"~     Acute respiratory infection (ARI) constitutes a leading cause of morbidity, hospitalization~     and mortality worldwide. The most common etiologic agents of ARI's, especially in children,~     are viruses.~      The study objective is to determine the viral and bacterial etiologies of ARIs in patients~     with lower respiratory tract infection in South East Asia.~      This is a laboratory based surveillance study, in which the archival specimens from~     hospitalized patients will be tested for respiratory pathogens other than influenza viruses~     Standard descriptive statistics will be used to present the findings~   "
192239|NCT01048060|"~     The purpose of this study is to collect bone marrow samples for experimental studies.~   "
192240|NCT01048047|"~     Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy~     on ankle-foot volume in hypertensive patients. It will be enrolled male or female~     outpatients, aged 18-65 years.~   "
192241|NCT01048034|"~     Azacitidine has proved prolonged overall survival in patients with high-risk MDS. Minor pilot~     studies have shown that treatment with Azacitidine can induce transfusion independency in~     previous transfusion dependent patients with low-risk MDS. This study will evaluate the~     effect of Azacitidine in transfusion dependent patients with low-risk MDS (IPSS low or int-1)~     or low risk CMML. Included patients should first have failed, or considered not being~     eligible to, treatment with EPO +/- G-CSF. Our hypothesis is that Azacitidine can lead to~     transfusion independency in this group of patients. Those patients who do not respond to~     treatment with Azacitidine alone, will be given treatment with the combination of Azacitidine~     and EPO where our hypothesis is that Azacitidine can restore sensitivity to EPO.~   "
192242|NCT01048021|"~     This clinical trial is being conducted to study lung function and movement of the major~     muscle involved in breathing (the diaphragm) after a brachial plexus nerve block (nerve~     freezing). The purpose of this study is to find out what effects (good and bad) ultrasound~     guided nerve freezing has on the movement of the patient's diaphragm and their lung function.~      The potential advantage of ultrasound guidance will be a lesser chance of freezing the nerves~     that innervate the diaphragm and thus having less of an effect on lung function.~   "
192243|NCT01048008|"~     DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated~     antineoplastic activities in human xenograft intracerebrally implanted tumor mouse models,~     acceptable preclinical toxicities in mouse, rat and dog models; and no behavioral cognitive~     impairment/neurotoxicities were noted in mouse and rat models.~      The drug is ready for human use as an soy bean oil/lecithin/glycerin water emulsion, the~     latter which has been documented - chemically and biologically to be stable and safe.~     Patients are currently being enrolled and treated with the protocol.~      Patients with advanced cancer, with or without central nervous system involvement will be~     eligible for enrollment, providing the required blood and other eligibility requirements are~     met.~   "
192244|NCT01047995|"~     The study aims to help us understand if the HIV drugs darunavir (taken with ritonavir) and~     raltegravir will affect each other when they are given at the same time.~      The purpose of the study is to assess the pharmacokinetics (how a drug is absorbed,~     distributed and eliminated from your body) of darunavir and ritonavir when these are taken~     with and without raltegravir.~      The duration of the study will be up to 50 days plus a screening visit which will take place~     up to 4 weeks prior to the start of the study, and a follow up visit which takes place 1-2~     weeks after the last dose of study medication.~      Subjects will continue to take 2 of their usual drugs (those called nucleoside reverse~     transcriptase inhibitors -NRTI) throughout the study.~      For the first 21 days subjects will take their usual NRTI plus raltegravir 400mg twice daily.~     After this, subjects will also receive either:~      Group 1) Darunavir/ritonavir 800mg/100mg once daily AND raltegravir 400mg twice daily or~     Group 2) Darunavir/ritonavir 800mg/100mg once daily AND raltegravir 800mg once daily~      Subjects will take this regimen for 14 days. Subjects will be randomly allocated to either~     Group 1 or 2. You will have an equal (50/50) chance of being allocated to Group 1 or 2.~   "
192261|NCT01047774|"~     The incidence of chronic pain after breast cancer surgery (CPBCS) is high in women diagnosed~     with breast cancer. Similar to other chronic postoperative pain conditions, existing~     treatments for CPBCS do not always work. Adopting the concept of using pain relieving~     measures prior to surgery rather than after it, may lead to decreased postoperative pain~     levels. Soy has been shown to have pain-relieving properties and may reduce the risk for~     developing chronic post-surgical pain. The purpose of this study is to determine the effects~     of adding soy protein to the diet before surgery on the development of chronic pain.~   "
192249|NCT01047930|"~     The primary aim of this project is to test the effect of exercise on acute nicotine~     withdrawal. Acute nicotine withdrawal is characterized by a complex array of symptoms~     associated with increased risk of relapse among individuals attempting smoking cessation. The~     available remedies do not target all aspects of withdrawal. For example, pharmacologic~     treatments reduce withdrawal-based craving, but have no effect on cue-related craving,~     altered sleep, and mood disturbances during withdrawal. Therefore, non-pharmacologic~     behavioral techniques with the potential to attenuate persistent withdrawal symptoms are~     needed. We hypothesized that exercise can be a valid non-pharmacologic strategy to improve~     these domains.~   "
192250|NCT01047917|"~     The purpose of this study is to test a simple meditation program that is easy to learn;~     inexpensive; easy to practice; non-religion based; and has wide applicability to multiple~     medical conditions. This program has been developed by the Complementary and Integrative~     Medicine Program at the Mayo Clinic.~   "
192251|NCT01047904|"~     The study will evaluate the performance and reliability of minor design changes to the~     Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy~     volunteers. Data collected from this study will enable the development of future applications~     and technology.~   "
192252|NCT01047891|"~     It is assumed, that the patients of the standard arm show a median progression-free survival~     time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a~     recruitment period of 18 months and follow-up for at least 12 months a total sample size of~     174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184~     patients will be randomized.~      A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the~     safety profile of the drug combination after 6 patients and after 12 patients have received 1~     cycle of treatment.~   "
192253|NCT01047878|"~     To determine whether gene expression analysis of primary tumor samples before and after~     chemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas~     (Ewings sarcoma (ES) and Osteosarcoma(OS)).~   "
192254|NCT01047865|"~     The hypothesis is that humoral and cellular islet-specific responses are an early risk factor~     for recurrence of autoimmunity and hyperglycemia in simultaneous pancreas-kidney (SPK)~     recipients independent of alloimmunity. This study will test the hypothesis and will assess~     their individual and combined predictive value.~   "
192255|NCT01047852|"~     The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the~     prevention of extubation failure and mortality in patients with either chronic respiratory~     disorders or hypercapnic respiratory failure during spontaneous breathing.~   "
192256|NCT01047839|"~     The primary objective is to assess the safety profile of IC51 in a pediatric population from~     regions where JEV is not endemic~   "
192257|NCT01047826|"~     The investigators are comparing two methods of standard treatments in distal tibial~     fractures. locked plating (M.I.P.O. technique) with intramedullary nailing.~      the investigators are hypothesizing that M.I.P.O group is superior to nailing in fractures of~     the distal third of the tibia.~   "
192258|NCT01047813|"~     Consumption of a low glycemic index (GI) diet has been shown to improve glycaemic control in~     type 2 diabetics(Brand−Miller et al., 2003; Jenkins et al., 2008). In addition to the~     benefits for glycaemic control there is some evidence for acute improvements in cognitive~     performance after consumption of low GI foods compared with high GI foods in both adults~     (Benton et al., 2003; Kaplan et al., 2000) and adolescents (Ingwersen et al., 2007; Smith and~     Foster, 2008).~      Given these findings it is possible that low GI focused dietary interventions designed to~     improve glycaemic control and health outcomes for diabetic patients could also improve the~     cognitive function of these patients. This is of particular relevance in light of the~     evidence associating type 2 diabetes with cognitive decrements (Awad et al., 2004; Stewart~     and Loilitsa 1999; van Harten et al., 2006). To date two studies with type 2 diabetics have~     reported that a low GI breakfast was associated with increased verbal memory performance~     compared to a high GI breakfast (Greenwood et al., 2003; Papanikolaou et al. 2006). Further~     research should investigate the benefit of low GI foods to cognition.~      The aim of this study is to examine the effects of high and low glycaemic index breakfast on~     cognitive performance in adults with type 2 diabetes. Participants will perform a battery of~     cognitive tests after consuming 3 different breakfasts (high GI, low GI, and water) on 3~     different tests days. The participants will be recruited from the general public and from the~     Leeds Teaching Hospital diabetes clinic.~      This research can benefit the development of specific dietary behaviours aimed at reducing~     diabetes related cognitive decline. This research is part of a PhD funded by the Economic and~     Social Research Council and the University of Leeds.~   "
192259|NCT01047800|"~     Background:~      Functional gastrointestinal disorder (FGID) is the most common gastrointestinal disease in~     daily clinical practice. The disease is symptomatic but has no identifiable cause by standard~     diagnostic tests such as endoscopy. It is characterized by its frequent relapses and thus the~     disease causes a significant level of stress and anxiety to patients. Due to the complexity~     and chronicity of the disease, it is believed that appropriate counseling on the nature and~     management of the disease is necessary to decrease patient's anxiety level and improve~     quality of life.~      Indication:~      Patients who have symptoms suggestive of FGID including non-erosive gastroesophageal reflux~     disease (NERD), functional dyspepsia (FD) or irritable bowel syndrome (IBS).~      Aim:~      To validate the effectiveness of counseling in patients suffering from FGID.~      Method:~      Patients recruited to the study will follow the usual management of patients attending the~     Gastroenterology specialty clinic in Prince of Wales Hospital. Standard blood tests and~     endoscopy will be performed. Standard medication will be given to the patients for 8 weeks~     after endoscopy and the patients will come back to the specialty clinic for a final visit.~      The patient will be given an on-demand follow up within 1 year option at final visit. The~     patient will decide if he/she wants to come back to our specialty clinic to follow up his/her~     problem within one year.~      Follow-up after Final Visit Follow-up questionnaires will be mailed to patients 6 months, 1~     and 2 years after Final visit.~      Randomization:~      All the patients will be randomized into two groups in First Visit: 1) Control group, and 2)~     Counseling group. Both groups of patients will follow the above protocol, except that 2 extra~     counseling sessions will be arranged for the Counseling group immediately after visiting the~     physician.~   "
192260|NCT01047787|"~     The investigators prospectively evaluated 89 consecutive outpatients (29 female) with stable~     congestive heart failure. The presence of sleep disordered breathing (SDB) and Cheyne-Stokes~     respiration (CSR) while awake were investigated by overnight polysomnography. Males and~     females were similar in age, body mass index, and LVEF. Prevalence of SDB was higher in males~     than females. During follow up of 25±10 months, 27% of the population died. Nonsurvivors had~     lower LVEF (p=0.01), worse NYHA class (p=0.03) a higher proportion of CSR-awake (p<0.001)~     than survivors.~   "
192264|NCT01047735|"~     This research study is being performed to begin to determine the effectiveness of two~     dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce~     weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in~     moderately obese patients.~      T2DM is currently the 6th leading cause of mortality in the United States and is a major~     cause of kidney failure, blindness, amputations, heart attack, and other vascular and~     gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle~     modifications with or without glucose lowering agents. Neither treatment alone, or in~     combination, results in complete resolution of diabetes and its potential long-term~     complications. Bariatric surgery has been proven as an effective treatment to accomplish~     sustained and significant weight loss for those with severe obesity and has been shown to~     induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment~     options, it is not clear whether diabetes is influenced by the type of surgery or by the~     amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss~     induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class~     I and Class II obesity, or approximately 65-95 pounds overweight depending on your height).~     More well-controlled studies are needed to more completely inform health care decision making~     and clinical practice in this area. This research study aims to obtain preliminary~     information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic~     Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive~     lifestyle intervention to induce weight loss with diet and increased physical activity.~   "
192265|NCT01047722|"~     Purpose of the present research project is to study a new in-vivo test for abnormal platelet~     function and to study the effect of certain drugs on clinical bleeding. This is a randomized~     clinical trial of a new in-vivo test of platelet function known as the bleeding volume~     test(BVT)which relies on an on-line measurement system. This trial will assess the~     sensitivity and specificity of the new BVT by studying the effects of aspirin which is known~     to affect platelet function in-vivo. This is not a clinical trial of drugs. This is a~     clinical trial of a novel in-vivo on-line laboratory test.~      The BVT measures the total volume of blood in the discrete blotches of blood on the blotter~     paper during the BT test and thus the BVT gleans valuable additional information from the~     bleeding time test (BTT)procedure. We hypothesize that the BV test will be a more accurate,~     specific and sensitive test for diagnosing platelet function abnormalities and for detecting~     a person's bleeding tendency compared to the BTT, and commercially available in-vitro~     platelet function tests.~   "
192266|NCT01047709|"~     Stroke is the leading cause of adult disability and the third leading cause of death in the~     United States. Unfortunately, there are few therapies that have been proven to improve stroke~     outcome. Sleep apnea is an emerging stroke risk factor and has a well established association~     with higher mortality and poor functional outcome following stroke. Over half of acute stroke~     patients have sleep apnea, suggesting that it may be a important target for therapy.~     Attenuation of sleep apnea severity may result in improved stroke outcomes. However, the~     standard treatment for sleep apnea is not well-tolerated among stroke patients. An~     alternative treatment is avoidance of supine sleep. Supine sleep is very common in acute~     stroke patients, and therefore this treatment may have particular relevance to the stroke~     population. The proposed study will be conducted in two phases. The first phase is a~     randomized, crossover design in which acute stroke patients will be given positional~     treatment (to avoid supine sleep) on one night during their stroke hospitalization. This will~     be compared with another night of sleeping without positional therapy. The order of~     treatments (standard vs positional therapy) will be random. The first phase will demonstrate~     the proof of concept: that stroke patients given positional therapy to avoid supine sleep~     will (1) sleep less on their backs, and (2) will have improved sleep apnea parameters with~     positional therapy. In the second phase, those identified to have sleep apnea will be~     randomized to receive positional therapy at home for three months, or standard therapy. This~     second phase will demonstrate the adherence/feasibility of three months of positional~     therapy, and will allow us to estimate effect size based on a functional outcome measure. The~     data obtained from this pilot clinical trial are essential to plan a large efficacy study.~   "
192267|NCT01047696|"~     The purpose of this study was to determine whether reduced exposure to indoor air pollution~     would reduce ALRI incidence in children <18 months of age. Households were randomized to~     receive a chimney stove (intervention group) or continue using an open fire for cooking and~     heating (control group).~   "
192268|NCT01047683|"~     The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to~     placebo in lowering fasting triglyceride levels in patients with very high fasting~     triglyceride levels ≥ 500 and ≤ 2000 mg/dL.~   "
192269|NCT01047670|"~     Septic shock is a frequent reason for admission on pediatric intensive care units.~     Interventions which can change morbidity and mortality of septic shock patients are of great~     interest. Steroid replacement in adults with severe sepsis and septic shock have been~     extensively studied. It was recently demonstrated that low dose steroid (< 300mg/ day) used~     for more than 5 days was associated with decreased mortality and lower requirement of~     vasoactive support in the adult population that had a low response to the ACTH test. However,~     this was not confirmed in the latest results from the CORTICUS study. Use of low dose~     hydrocortisone, or any other steroid has not been studied in critically ill children.~     Mortality associated with sepsis in children has decreased in the last decade and currently~     it is close to 10%, making it difficult to power a study able to show reduced mortality.~     Taking into account the results from previous studies reporting the high incidence of adrenal~     failure and its association to worse outcome, we have designed a clinical trial to evaluate~     the effect of low dose hydrocortisone in children with septic shock: Cortisol Replacement in~     Children with Sepsis Study.~   "
192270|NCT01047657|"~     Sixty percent of patients with difficult to control asthma seen in our outpatient clinic are~     obese. The impact of weight reduction in this subpopulation of asthmatics has not been~     studied. Our aim is to evaluate the impact of weight reduction on asthma control of these~     patients.~   "
192271|NCT01047644|"~     The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes~     every 3 months rather than every four to six weeks.~      It is routine practice to flush ports every four to six weeks, according to the~     manufacturer's recommendations, using salt solution followed heparin if needed. This study~     examines the effectiveness of port flushes at an alternative interval of 3 months, reducing~     the number of visits to the health-care provider.~   "
192272|NCT01047631|"~     Diastolic heart failure is now being recognized as a key form of heart failure in older~     people. The focus of this research is to study ways to improve and maintain physical activity~     and functioning. This knowledge may improve the health and well-being in people with~     diastolic heart failure.~   "
192329|NCT01046877|"~     The objective of the study is to evaluate the safety and efficacy of the Acclarent~     Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in~     patients indicated for such treatment for chronic otitis media with effusion (OME) or~     recurrent acute otitis media (AOM).~   "
192273|NCT01047618|"~     Venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep vein thrombosis~     (DVT), is a common complication and leading cause of death in cancer patients. Large,~     population-based studies have shown that patients with cancer have four- to seven-fold~     increased risk of developing VTE compared with patients without cancer. VTE would be frequent~     in patients with advanced gastric cancer, especially associated chemotherapy. However,~     relatively few studies have been conducted regarding the incidence of VTE in Asian cancer~     patients. According to previous review, Asian patients significantly lower risk of developing~     VTE. The rate of VTE with advanced gastric cancer, and associated chemotherapy is not known~     in Asian patients. In addition, the impact of VTE on overall survival has not been documented~     in these patients.~   "
192274|NCT01047605|"~     To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance~     and Pascoflair 425 mg) in comparison to placebo on brain activity.~   "
192275|NCT01047592|"~     Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the~     pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing~     agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated~     clinical benefits for schizophrenia patients. This project aims to compare the efficacy and~     safety of sarcosine and combination of sarcosine and BE, as adjunctive therapy for~     schizophrenia, and to explore the possible synergistic effects of them. Sixty chronic~     schizophrenic inpatients will be enrolled in the 12-week double-blind, placebo-controlled~     trial. The participants receive stable antipsychotic regimens concomitant with sarcosine (2~     g/d) (N=21), sarcosine(2 g/d) + BE(1 g/d ) (N=21), and placebo(N=21). Measures of clinical~     efficacy and side-effects were determined every 3 weeks. Measures of cognitive function were~     determined at the beginning and the end of the study. The efficacies of three groups are~     compared, and the characteristics of better responders are analyzed.~   "
192276|NCT01047579|"~     This study is designed to evaluate caregiver preference for Exelon® patch (target patch size~     10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under~     cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.~   "
192277|NCT01047566|"~     The primary objective of this study is to:~      Assess whether the addition of dronedarone to existing conventional rate control therapy~     leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at~     rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.~      The secondary objectives of this study are to compare both study arms with regard to:~        -  Ventricular rate after 3 months~        -  Number of registered AF episodes~        -  Number of symptomatic AF episodes~        -  Severity of AF and AF-like symptoms~        -  Rate of premature study discontinuation~        -  Number of symptomatic episodes of bradycardia~        -  Incidence of low heart rate (<60 bpm)~   "
192278|NCT01047553|"~     This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one~     inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be~     the group to refer to when safety results of formoterol arm will be evaluated. 240 patients~     with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120~     patients on standard COPD therapy).~   "
192279|NCT01047540|"~     The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention~     of reactivation of genital herpes~   "
192280|NCT01047527|"~     The transdermal nicotine patch is the most widely used form of tobacco dependence treatment~     in the US and Europe, but most smokers are unable to successfully quit with this form of~     treatment. Failure to respond to this treatment may, to a large extent, be due to the use of~     nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a~     controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase~     quit rates significantly. We propose here a clinical trial to replicate and extend these~     results to a community setting in the real-world, using the same research design utilized in~     clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate~     dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks),~     extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The~     main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness,~     safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for~     maintenance therapy with transdermal nicotine will also be assessed. The study results may~     change how we treat nicotine dependence with transdermal nicotine.~   "
192281|NCT01047514|"~     This study will evaluate the effectiveness of an online Chronic Disease Self-Management~     Program for participants in Canada living with chronic health conditions. This pilot will~     look for improvements in health status, health behaviors and health care utilization.~   "
192282|NCT01047501|"~     The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to~     placebo in lowering high fasting triglyceride levels in patients with high risk for~     cardiovascular disease and fasting triglyceride levels ≥ 200 and < 500 mg/dL.~   "
192283|NCT01047488|"~     Polyneuropathy of different etiologies is often associated with pain and the standard~     treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this~     study is that the combination of the gabapentinoid pregabalin and the antidepressant~     imipramine will provide better pain relief than the single compounds alone.~      This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin~     300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include~     60 patients and the treatment outcome will be pain intensity as measured by numeric rating~     scales.~   "
192284|NCT01047475|"~     This is a randomized, double-blind, parallel group, placebo-controlled study evaluate the~     preliminary efficacy and safety of MB-6 (320 mg/capsule, 6 capsules tid) versus placebo in~     addition to standard chemotherapy in the treatment of patients with metastatic colorectal~     cancer.~   "
192285|NCT01047462|"~     The purpose of this study is to determine whether laparoscopic lavage changes the rate of~     severe complications in patients with acute perforated diverticulitis who traditionally are~     treated with primary resection.~   "
192312|NCT01047098|"~     Most breastfeeding women are told by their health care provider to continue taking prenatal~     vitamins after they give birth. A woman's requirement for iron while breastfeeding is low,~     yet prenatal vitamins contain a large amount of iron. The purpose of this study is to see if~     breastfeeding women are getting too much iron when taking prenatal vitamins.~   "
192286|NCT01047449|"~     Surgery for blocked arteries in the heart (coronary artery bypass grafting) can be~     accomplished using veins from the leg sewn onto the heart to provide an alternate path for~     blood flow, i.e. 'bypassing' the blockages. These veins themselves can block over time. This~     may result in part simply from the trauma from the surgery, in other words, by removing the~     vein from the leg and then sewing it to the heart. Another mechanism may be the abnormal~     metabolic processes within the body responsible for the plaque build-up of the heart arteries~     in the first place - this may lead to the blockages of the veins used for bypass. In the~     present era of heart bypass surgery, this incidence of veins blocking remains high despite~     advances in blood thinners and cholesterol medications. This study is designed to determine~     whether two new interventions may potentially reduce the incidence of blockages in the veins~     used for heart bypass surgery. One is a surgical technique significantly reducing the trauma~     associated with removing the leg vein prior to use as a bypass graft onto the heart. The~     second intervention is the use of a nutritional supplement before and after surgery which is~     composed of fish oils. The study will recruit sufficient patients to provide strong and~     relevant conclusions regarding both study questions. It will be highly applicable also~     because it will include approximately 1,550 patients from approximately 50 hospitals across~     many countries. We believe these techniques will result in significantly less vein blockages~     in patients one year after heart bypass surgery.~   "
192287|NCT01047436|"~     The purpose of this study is to compare the efficacy of Artemether Sublingual Spray~     (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum~     malaria, or children with uncomplicated malaria with gastrointestinal complications.~   "
192288|NCT01047423|"~     Cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients~     with established high blood pressure. High blood pressure is a very common medical condition~     that can lead to vascular complications i.e. problems with the blood vessels in the body. One~     way of detecting early changes in these blood vessels as a result of high blood pressure is~     to measure their compliance/flexibility with a noninvasive technique known as ultrasound and~     with a simple blood test. The investigators are trying to establish whether these early~     changes in blood vessels can be significantly improved by the use of both a cholesterol and~     blood pressure lowering tablet at an earlier stage than is currently advised. The~     investigators hope that the early combination of these tablets will prove more effective than~     the use of a blood pressure lowering tablet by itself and therefore possibly reduce the risk~     of long term complications developing.~   "
192289|NCT01047410|"~     The aim of the present study is to compare the outcomes of standard care to the effects of~     exercise alone, and exercise combined with nutrition counseling, on post-transplantation~     weight gain and quality of life in renal transplant recipients (RTR). The primary outcomes~     are post-transplantation weight gain and cardiometabolic risk, and quality of life regarding~     physical functioning.~      Our secondary outcomes are barriers and success factors regarding lifestyle intervention in~     RTR, the barriers and success factors for intervention for healthcare professionals, and~     long-term adherence to physical activity during the follow-up phase.~   "
192290|NCT01047397|"~     The purpose of this study is to characterize the safety and efficacy of repeat doses of~     compound 1278863A in subjects with anemia.~   "
192291|NCT01047384|"~     Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage~     following major orthopedic surgery often involves a large, deep incision with considerable~     tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such~     surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay~     mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical~     costs.~      We design a prospective randomized study for postoperative pain control following total knee~     arthroplasty.~   "
192292|NCT01047371|"~     The purpose of this study is to evaluate patient related factors determining length of stay~     in hospital after arthroplasty surgery.~   "
192293|NCT01047358|"~     This non-interventional study is to monitor use in real practice in Korea including adverse~     events on Aromasin (Exemestane).~   "
192294|NCT01047345|"~     This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women~     between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants~     will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the~     Base Study. Participants who receive placebo in the Base Study will be eligible to receive~     vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.~   "
192295|NCT01047332|"~     The purpose of the study is to determine the best management of bile duct narrowing~     (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the~     liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct~     causing pain, jaundice (yellow skin and eyes), itchy skin and fever.~   "
192296|NCT01047319|"~     To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled~     MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability~     and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing~     multiple sclerosis.~   "
192297|NCT01047306|"~     The purpose is to evaluate the course of disease progression in MPS IIIA patients who are~     untreated to identify potential surrogate endpoints that may be utilized in future ERT trials~     of MPS IIIA via defined assessments including standardized clinical, biochemical,~     neurocognitive, behavioral, developmental, and imaging measures.~   "
192311|NCT01047111|"~     Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection~     remains the basic method of management of this malignancy. Although different approaches have~     been described for the surgical resection of esophageal cancer, there is no statistical~     evidence based on large scale prospective randomized trials with regard to the issue that~     which is the optimal surgical approach for esophageal cancer. The purpose of this study is to~     test two different approach of transthoracic esophagectomy (Right Side Thoracotomy plus~     Midline Laparotomy Approach: Ivor-Lewis Procedure and Left Side Thoracotomy Approach: Sweet~     Procedure) in middle or lower third intrathoracic esophageal cancer. This research is being~     done to see whether one approach is superior than the other approach with better long-term~     outcome and acceptable postoperative short-term outcome or not.~   "
192327|NCT01046903|"~     The objective of this study is to observe the safety, tolerability, and compliance in the use~     of Fragmin® for prolonged thromboprophylaxis in post-surgery high-risk orthopedic patients.~   "
192298|NCT01047293|"~     RAD001 (everolimus) is a novel oral derivative of rapamycin. RAD001 has been in clinical~     development since 1996 as an immunosuppressant in solid organ transplantation and has~     obtained marketing authorization (Certican®) for prophylaxis of rejection in renal and~     cardiac transplantation in a number of countries, including the majority of the European~     Union. RAD001 has been in development for patients with various malignancies since 2002.~      RAD001 is being investigated as an anticancer agent based on its potential to act:~        -  Directly on the tumor cells by inhibiting tumor cell growth and proliferation~        -  Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent~          inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced proliferation~          of endothelial cells). The role of angiogenesis in the maintenance of solid tumor growth~          is well established, and the mTOR pathway has been implicated in the regulation of tumor~          production of proangiogenic factors as well as modulation of VEGFR signaling in~          endothelial cells.~      At weekly and daily schedules and at various doses explored, RAD001 is generally well~     tolerated. The most frequent adverse events (rash, mucositis, fatigue and headache)~     associated with RAD001 therapy are manageable. Non-infectious pneumonitis has been reported~     with mTOR inhibitors but is commonly low-grade and reversible.~      Both FOLFOX and bevacizumab are well established for treatment of metastatic colorectal~     carcinomas. FOLFOX-6 can be combined safely with Bevacizumab and is currently in phase 3~     testing for adjuvant therapy and is commonly used as a first line treatment regimen for~     metastatic colorectal cancers 25. There is an enhanced interest in development of more~     effective regimens for colorectal cancers. RAD001 is a mTOR inhibitor that has preclinical~     and clinical activity in colorectal cancers. RAD001 downregulates the mTOR pathway which can~     lead to direct antiproliferative effects as well as decreased production of Vascular~     Endothelial Growth Factor. A combination of RAD001 at 10 mg per day in combination with~     Bevacizumab 10 mg/kg every 2 weeks has been shown to be efficacious and safe. In another~     trial, RAD001 was shown to have many patients with stable disease and clearly needs to be~     given in combination therapy.~   "
192299|NCT01047280|"~     The purpose of the study is to examine how a naturally occurring fat found in meats, such as~     beef and lamb and milk, called conjugated linoleic acid (CLA), will affect your body weight~     and body fat content, blood fat levels, as well as selected safety parameters. The CLA will~     be supplemented in an oil form and will be added to solid foods as provided by the metabolic~     kitchen at the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN).~   "
192300|NCT01047267|"~     The objective of this study is to determine whether pharmacokinetic parameters of~     anidulafungin correlate with disease severity and plasma protein levels in critically ill~     patients.~   "
192301|NCT01047254|"~     Apathy in dementia prevents successful application of non-pharmacological treatments,~     accelerates cognitive and functional decline and increases disease-related costs by earlier~     need for full-time care. Apathy is a distinct entity and occurs independently of other~     neuropsychiatric syndromes, like depression.~      Today, there is no high-level evidence for any effective treatment of apathy in AD. In~     contrast to other neuropsychiatric syndromes in AD, like psychosis and depression, and~     despite its high prevalence and clinical relevance, apathy has never been the primary outcome~     in a clinical trial. Basic and clinical research has provided a distinct model of the~     pathophysiology of apathy with dopamine and norepinephrine as the key neurotransmitter~     systems involved. The antidepressant Bupropion is a dopamine and norepinephrine reuptake~     inhibitor. There is evidence from case-series, that Bupropion reduces apathy in patients with~     organic brain disorders. This study will test the efficacy and safety of Bupropion in the~     treatment of apathy in AD in a 12-week multicenter doubleblind placebo controlled trial.~     Secondary endpoints will be quality of life of patients, caregivers' distress, ability of~     patients to perform activities of daily living,utilization of healthcare resources by~     patients and by caregivers, and cognitive functions.~   "
192302|NCT01047241|"~     The aim of the study is to investigate the absorption and clinical effect of nasal~     administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to~     medical procedures in hospitalized children.~   "
192303|NCT01047215|"~     The goal of this research is investigating the heart rate changes in schizophrenic and~     bipolar patients under the medication of aripiprazole and quetiapine. In the mean time, we~     are hoping further investigating the interrelationship of medicine dosage and heart rate~     change, in order to acquire the best relationship both effectiveness as well as safety in~     acceptable heart rate change of clinical suggestion.~   "
192304|NCT01047202|"~     A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months~     infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine~     (PANFLU.1).~   "
192305|NCT01047189|"~     The purpose of this research study is to evaluate the effectiveness of two different types of~     topical acne medication. This study will help to determine if one combined medication results~     in better acne improvement than two separate medications for acne.~   "
192306|NCT01047176|"~     To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after~     drug-eluting stents implantation who take statins.~   "
192307|NCT01047163|"~     A major contributor to frailty and immobility in the elderly is the age related loss of~     muscle mass (sarcopenia). Cardiovascular disease (CVD) is the leading cause of mortality in~     the elderly, with high blood cholesterol and lipids being the major modifiable risk factor.~     Statins reduce blood cholesterol, but muscle related pain, tenderness and discomfort~     (myopathy) is an adverse event associated with statin therapy, with older people being at a~     much greater risk. Statin myopathy presents as muscle aches and weakness, with or without~     evidence of muscle damage; however the underlying mechanisms responsible for these symptoms~     are poorly understood. Using an animal model, the applicants have shown the main pathway~     regulating muscle protein synthesis is inhibited in statin myopathy, and genes regulating~     muscle protein breakdown, the inhibition of muscle carbohydrate use and inflammation are~     dramatically increased. Therefore we wish to determine whether these changes are seen in the~     muscle of older people with symptoms of statin myopathy, and whether this is associated with~     lower muscle mass and impaired muscle function compared with older people with no history of~     statin use. Identification of the mechanisms involved in statin myopathy could lead to~     effective therapy for older people unable to tolerate statins.~   "
192308|NCT01047150|"~     Research Questions:~        1. Is there a significant difference between the causal repeat rate of myocardial perfusion~          studies for Tc99m tetrofosmin and Tc99m sestamibi?~        2. Is there a significant difference in the causal repeat rate of myocardial perfusion~          studies for Tc99m tetrofosmin and Tc99m sestamibi if an independent technologist~          reviewer blinded to the radiopharmaceutical makes the decision to repeat the study?~        3. Is there a significant difference in the quantitative diagnostic measures reported~          between the original and the acceptable repeated studies?~   "
192309|NCT01047137|"~     Several studies have shown a relationship between psychological stress and chronic urticaria~     (hives). The primary objective of this study is to evaluate the effect psychological stress~     intervention has on chronic urticaria.~   "
192313|NCT01047085|"~     Publications with different conclusions are available with regard to the correlations between~     the cholecystolithiasis, cholecystectomy and gastroesophageal reflux disease (GERD). In this~     study, the controversial relationship between cholecystolithiasis, cholecystectomy and GERD~     is discussed through the impedance pH method which started to be used in recent years, a~     method indicating the gas and liquid (acid and non-acid) gastroesophageal reflux (GER) and~     esophageal clearance time.~   "
192314|NCT01047072|"~     The purpose of the study is to see how well reduced intensity conditioning followed by a stem~     cell transplant from a donor (allogeneic) works in treating patients with severe systemic~     sclerosis. In an allogeneic stem cell transplant procedure, stem cells are taken from a~     healthy donor and transplanted into the patient. Stem cells can be donated by a family member~     or an unrelated donor who is a complete tissue type match.~   "
192315|NCT01047059|"~     The patients will be treated with erlotinib and bevacizumab for a six-week period. Imaging~     procedures will be performed at baseline, after one week of therapy and after the six weeks~     of treatment.~      The combination of erlotinib and bevacizumab represents an effective therapeutic strategy in~     NSCLC with the highest response rates ever reported for relapsed NSCLC having been observed~     recently in a phase II trial. Early differentiation of patients profiting and of patients not~     profiting from this therapy is of major relevance for further improving this targeted therapy~     approach and to develop more effective, personalized treatment strategies. We aim at this~     early identification by the combination of molecular and functional imaging tools (FDG-,~     FLT-PET, DCE-MRI), molecular marker analyses in tissue and peripheral blood (EGFR- and KRAS~     mutational status and high throughput mutational profiling in tumor tissue,~     angiogenesis-associated biomarkers and expression profiling in peripheral blood) and~     pharmokokinetic analyses. From the combined analyses of these tools we expect a better~     understanding of the host-drug interaction as a precondition for further improvement of~     erlotinib-bevacizumab combination therapy in NSCLC~   "
192316|NCT01047046|"~     This study is a retrospective chart review including all patients who received surgical~     placement of a SNM device with Dr. Noblett from 2001 to the present.~   "
192317|NCT01047033|"~     This purpose of this study is to determine whether a health education intervention for~     clients of a microcredit organization in Peru will improve health outcomes among clients and~     their children.~   "
192318|NCT01047020|"~     The primary goal of this study is to provide comprehensive and objective information on~     impairments of musculoskeletal health, sensory function, and fitness among a large group of~     childhood ALL survivors, and to define high risk groups by assessing treatment factors that~     contribute to impaired function. This study includes a direct, objective evaluation of~     musculoskeletal function, sensory capacity, fitness, and physical activity patterns among~     adults who were treated for childhood ALL at St. Jude Children's Research Hospital (SJCRH)~     between 1980 and 1999. Among 899 ALL survivors, all of whom are eligible for an~     institutionally funded clinical study of medical late effects, the study will recruit 364 to~     participate in our evaluations. The study will also recruit 364 individuals for a comparison~     group, frequency matching on race/ethnicity, age and gender.~   "
192319|NCT01047007|"~     The study evaluates safety of MK1775 in monotherapy, and in combination with 5-FU alone or~     with 5-FU/CDDP in Japanese patients with solid tumor~   "
192320|NCT01046994|"~     A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35~     (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply~     overweight patients. A new prospective study was then planned with the aim to gain insight in~     the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will~     be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic~     clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1~     month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be~     performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the~     fifth year.~   "
192321|NCT01046981|"~     Tumescent Antibiotic Delivery (TAD) is a technique for improving the prevention of surgical~     site infections (SSI). TAD involves the subcutaneous infiltration of tumescent local~     anesthesia (TLA) containing water soluble antibiotic(s) such as cefazolin and metronidazole.~     TLA consists of the subcutaneous infiltration of very dilute lidocaine (≤ 1 gram/liter) and~     epinephrine (≤ 1 milligram/liter) with sodium bicarbonate (10 milliequivalents/liter) in a~     physiologic solution of sodium chloride which produces intense local anesthesia associated~     with profound wide-spread vasoconstriction lasting for more than 12 hours. Compared to~     intravenous antibiotic delivery (IVAD), TAD is expected to produce higher local tissue~     concentrations of the antibiotic(s) for longer periods of time and lower systemic/serum~     antibiotic concentrations. This clinical trial will compare TAD to IVAD with respect to~     pharmacokinetic evidence for possible improved SSI prevention.~   "
192322|NCT01046968|"~     Metabolic syndrome is directly related to obesity. This study investigated the use of a plant~     based formulation to improve on the condition of people with metabolic syndrome.~   "
192323|NCT01046955|"~     The purpose of this study is to observe in a randomized prospective study the effectiveness~     and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of~     living donor (LD) kidneys, compared with the investigators standard treatment protocol of~     Zenapax® and maintenance immunosuppression.~   "
192324|NCT01046942|"~     The purpose of this study is to determine whether adding clopidogrel to aspirin after~     coronary bypass operation (CABG) improves graft patency, in patients that have preoperatively~     increased platelet activity(hypercoagulable) and therefore greater risk of graft occlusion(~     thrombosis).~   "
192325|NCT01046929|"~     Limonene is a major component in the essential oils of citrus fruits. It has demonstrated~     promising breast cancer preventive and therapeutic effects in preclinical model systems. This~     early phase clinical study will evaluate the distribution of limonene to the breast tissue~     and its associated biological activities after 2 to 6 weeks of limonene dosing in women with~     a recent diagnosis of early stage breast cancer. This study will help evaluate the potentials~     of developing limonene as a breast cancer preventive agent.~   "
192326|NCT01046916|"~     This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and~     efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without~     radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).~   "
192331|NCT01046851|"~     Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist~     Nopan to be an effective antidepressant with a rapid onset of action. It is therefore~     hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality.~     Depression, suicidality, and overall functioning will be assessed before, during and after a~     four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug~     will show rapid improvements in objective and subjective measures of these variables.~   "
192332|NCT01046838|"~     In patients with Doppler echocardiographic signs of elevated LV filling pressures despite~     preserved LV systolic function after AMI treatment with the phosphodiesterase inhibitor~     sildenafil 40 mg three times daily for 9 weeks will compared with placebo~        1. Improve resting LV filling and cardiac hemodynamics.~        2. Improve exercise capacity.~        3. Improve filling pattern and cardiac hemodynamics during exercise.~   "
192333|NCT01046825|"~     This is a phase III clinical trial using risk-adapted therapy. Treatment outcomes for~     children with B-cell NHL are excellent. Further improvements in outcome will likely be~     achieved through more focused study of the biology of the tumors and prospective studies of~     the late effects of treatment. Toward this end, this study features a spectrum of prospective~     biologic and late effect studies performed in patients treated with a modified regimen~     derived from the very successful LMB-96 regimen.~   "
192334|NCT01046812|"~     The investigators propose a novel assessment of oral malodor (halitosis) by a quality of life~     (QOL) questionnaire designed specifically for halitosis and a new treatment for halitosis by~     improvement of mouth dryness.~   "
192335|NCT01046799|"~     The purpose of this study is to determine whether hepatitis B immunoglobin can be~     discontinued early after hepatitis B virus (HBV) induced liver transplantation and be~     replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.~   "
192336|NCT01046786|"~     To investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood~     mononuclear cell transplant in the treatment of chronic spinal cord injuries.~   "
192337|NCT01046773|"~     IBD is caused by an abnormal immune response to the gut bacteria in people who are~     genetically predisposed. There has been a huge increase in the number of people diagnosed~     with IBD since World War II, likely due to changes in our environment. It is possible that~     the abundance of vitamin D in the body may be one of those environmental factors that the~     investigators can control to make patients with IBD better.~      Vitamin D acts on cells of the immune system and causes many effects, including the~     production of a natural antibiotic called cathelicidin. The investigators know that when~     people are supplemented with vitamin D, levels of cathelicidin produced by these immune cells~     increase. By supplementing children with Crohn's disease with vitamin D, the investigators~     may be able to alter their immune system naturally, making their disease better. A~     consensus of vitamin D experts believes that vitamin D levels need to reach a level of 40-70~     ng/mL in the blood in order to have effects on the immune system. Raising vitamin D levels to~     this range is one of the goals in the current study.~   "
192338|NCT01046760|"~     Rolandic Epilepsy is the most common form of childhood epilepsy. It is classified as~     idiopathic, age-related epilepsy syndrome with benign evolution. The absence of~     neuropsychological impairment is part of the criteria of benignity of this epilepsy syndrome.~     However recently have been suggested several deficits related to attention and language. The~     purpose of this study was assess school performance and to investigate problems of praxis in~     patients with rolandic epilepsy as compared to a control group composed of normal children~     with age, gender and educational level equivalents.~   "
192339|NCT01046747|"~     Hypothesis~      There is no difference in the incidence of pin tract infection and pin loosening in case of~     lower extremity external fixators when self-drilling schanz pins are used with or without~     pre-drilling.~      Primary Objective~      The primary objective is to determine whether pre-drilling holes for external fixation pin~     insertion is superior to not pre-drilling holes for external fixation pin insertion in~     regards to the incidence of pin tract infection and pin loosening.~      Secondary Objective~      If any difference is found between the two techniques then, we will quantify and qualify~     those differences. The incidence of pin site infection and pin loosening in general will be~     determined and will also be stratified for site and size of pin. An attempt to identify risk~     factors for pin site infection will be made by observing the effect of secondary prognostic~     factors like mode of injury, diabetes, smoking, compartment syndrome, peripheral vascular~     disease, neurovascular injury. Interobserver reliability of the grading system for pin~     infection will also be determined.~   "
192340|NCT01046734|"~     An influenza pandemic has recently been declared, involving the novel A(H1N1) 'swine flu'~     virus. This has spread to almost 100 countries worldwide in less than two months, causing~     widespread disease so far in Mexico, USA and Canada. It is highly likely that over the next~     12 months, many countries including the UK will be affected by widespread illness. In the UK~     this wave of intense flu activity is most likely to occur in late autumn 2009.~      Very little is known about the new H1N1 pandemic virus. For example we do not know how long~     the virus is excreted by infected humans and how much virus is spread to surfaces and carried~     in the air. This is very important to know as soon as possible because it affects the advice~     that will be given to healthcare workers about controlling the spread of infection to~     themselves and other patients. Similarly we need this information so we can give good quality~     advice to families who will have to look after each other in their own homes.~      The best way to obtain this information is to ask patients who get pandemic flu soon (in~     August, September and October) to help us by agreeing to give a daily nose swab sample for~     just over one week so we can see how much virus is in the nose day by day and how quickly~     this disappears. At the same time we will take samples from hard surfaces in a patient's room~     or home and sample the air using a special filter device. We can then work out how much virus~     is being excreted, how long the 'danger period' is, whether surfaces are more or less~     important than the air that we breathe (in terms of catching the virus) and if we can advise~     on a 'safe distance' from the patient, beyond which there is relatively little chance of~     catching the illness.~   "
192514|NCT01044459|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled~     aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic~     obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in~     period, a 52-week treatment period and a 2-week follow up phone call. All patients will be~     randomized to one of two doses of aclidinium bromide.~   "
192341|NCT01046721|"~     Exenatide is a new drug which lowers blood sugar (glucose) levels for people with type 2~     diabetes. It has significant advantages over other treatments such as insulin as it causes~     weight loss in a group of people that is generally overweight. Data from studies involving~     exenatide have shown that it also has an effect on blood pressure. The mechanism for the~     blood pressure lowering effect is not known and has not been investigated previously.~     Exenatide may have an effect on blood vessels throughout the body and gut to reduce blood~     pressure. 12 healthy men (18-45yr) will be studied on 2 occasions. Limb blood flow, skin~     blood flow, gut blood flow, blood pressure, and heart rate will be measured half hourly for 4~     hours. Blood samples (3ml) for insulin and glucose determination will be taken via a cannula~     and 3-way tap at the same time points. A dose of either 5μg exenatide or saline will be~     injected under the skin of the abdomen and a breakfast will be provided during the study. A~     urine collection will be made over the duration of the study.~   "
192342|NCT01046708|"~     The purpose of this study is to assess the effect of luteal phase supplement (LPS) on~     pregnancy rate in IUI cycles stimulated with clomiphene citrate.~   "
192343|NCT01046695|"~     We propose to evaluate the use of Transcutaneous Electrical Nerve Stimulation (TENS) in~     patients having undergone Video-Assisted Thoracotomy Surgery (VATS) with the aim to determine~     if:~        -  Nurses will be able to apply TENS effectively and in a timely manner to post VATS~          patients.~        -  Use of TENS immediately after thoracic surgery and for the first 48 hours will add to~          patient's pain control.~        -  Tens will reduce medication use.~        -  Tens will reduce nausea and vomiting.~   "
192344|NCT01046682|"~     This is a phase II, open label, randomized-controlled pilot study designed to study both the~     efficacy and safety of salsalate in decreasing endothelial cell dysfunction, systemic~     inflammation, and insulin resistance in HIV-infected adults. The investigators hypothesis is~     that salsalate will reduce inflammation and therefore endothelial cell activation and insulin~     resistance. The sample size will be 40, with an equal number of people being randomized to~     one of two groups. The first arm will be randomized to salsalate therapy. The second arm will~     act as a control group. The study duration will be 13 weeks.~   "
192345|NCT01046669|"~     To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in~     subjects with septic shock who have high levels of endotoxin and are treated with standard~     medical care plus use of the PMX cartridge, versus subjects who receive standard medical care~     alone.~   "
192346|NCT01046656|"~     Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In~     children, it is commonly caused by enteric pathogens, especially rotavirus. The reported~     incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may~     prolong the hospital stay and increase medical costs. One of the potential strategies for the~     prevention of nosocomial infections is the use of probiotics. The number of studies have~     shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea.~     However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial~     diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating~     the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial~     gastroenteritis in a pediatric hospital setting.~   "
192347|NCT01046643|"~     The objective of this study is to evaluate the neurobiological effects of hormone therapy~     (HT) in healthy early postmenopausal women. The studies proposed in this project seek to~     define the association between different hormone forms (estradiol only and progesterone only)~     versus placebo on brain functional measures. The functional measures will include the~     performance of the volunteers on a comprehensive neuropsychological testing battery, and the~     brain functional responses to episodic memory (verbal and non-verbal) challenges as well as~     emotional processing determined with functional magnetic resonance imaging (fMRI).~   "
192348|NCT01046630|"~     The purpose of this study is to determine the effect of a single dose infusion of AZD 6765~     compared with placebo and ketamine on the blood oxygen level dependent signal using fMRI~     (functional Magnetic Resonance Imaging) in depressed subjects.~   "
192349|NCT01046617|"~     Infantile colic is characterized by excessive crying (defined as crying that last at least 3~     hours a day, for 3 days a week, for at least 3 weeks) in an otherwise healthy infant. The~     crying typically starts in the first few weeks of life and ends by 4-5 months of age. The~     condition is usually self-limited, with no long-term adverse effects; however, it may be very~     distressing to parents, hence, any safe and effective treatment would be desirable. Recently,~     it has been suggested that probiotics may offer some benefit.This is based on the results of~     one open randomized controlled trial. In this trial, 83 breast-fed infants with colic defined~     as >3 hours of crying on >3 days/week were randomly allocated to receive Lactobacillus~     reuteri DSM 17938 (108 colony-forming units, once daily 30 minutes after feeding) or~     simethicone (60 mg/day as 15 drops twice a day after feeding) for 28 days. Mothers followed a~     cow's milk free diet. By day 28 after randomization, mothers of infants in the probiotic~     group were significantly more likely than mothers of infants in the simethicone group to~     report a reduction from baseline in average crying time to less than 3 hours per day (95% vs.~     7%). In addition, median crying times were significantly shorter in the probiotic group than~     in the simethicone group. No adverse effects of L. reuteri were reported.~      Although the mechanism of action of L. reuteri for treating infantile colic has not been~     elucidated yet, the findings are very promising. However, there are some methodological~     limitations to the study, including no allocation concealment, no blinding, and no~     intention-to-treat analysis; these may result in selection, performance, and/or attrition~     biases and, eventually, invalidate the results. Another limitation of the study is the lack~     of a true placebo group. Given these consideration a new study is proposed that is aiming to~     overcome these limitations.~   "
192358|NCT01046500|"~     Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of~     living cells and is widespread in many food. It is involved in a number of biological~     processes, including insulin signal transduction, resulting in modulating insulin~     sensitivity. One hundred post-menopausal women from 50 to 60 years old, affected by metabolic~     syndrome (criteria are described in NIH ATP III) will be randomized into two groups: 50~     treated with myo-inositol 2 g twice per day and fifty treated with metformin for six months.~     Metformin is the drug usually used in diabetic and pre-diabetic conditions, as metabolic~     syndrome. The investigators hypothesize that the administration of myo-inositol would improve~     the insulin-receptor activity in these women, reducing insulin resistance as well as~     metformin.~      OUTCOME MEASURE: HOMA-IR, blood pressure level, serum triglycerides and cholesterol, BMI and~     waist circumference~   "
192359|NCT01046487|"~     The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate,~     given in association with a fixed dose of cyclophosphamide (50 mg bid).~   "
192815|NCT01040442|"~     The objective of the present study was to identify the effect of direct vibration at a~     frequency of 100 Hz, applied to the plantar region, on the balance of women aged 60 years or~     older. The hypothesis is that the place improves body balance.~   "
192350|NCT01046604|"~     In the absence of treatment, severe mitral valve regurgitation (MR) results in left atrium~     (LA) dilatation and hypertrophy, followed ultimately by left ventricular dysfunction and~     heart failure. One promising intervention for the prevention of the deleterious effects of~     pressure overload-induced cardiac hypertrophy and heart failure is dietary supplementation~     with n-3 polyunsaturated fatty acids (PUFAs). However, the molecular targets and mechanisms~     by which n-3 PUFAs exert their effects are not completely defined. A possible target of n-3~     PUFAs is the mitochondrial membrane which has broad implications given that mitochondrial~     dysfunction and altered metabolism have been associated with cardiac hypertrophy and heart~     failure. The investigators have recently identified significant mitochondrial dysfunction in~     the LA of patients with severe MR, as compared to their non-hypertrophied right atrium (RA).~     However, the investigators have not addressed the possibility that intervention with purified~     n-3 PUFAs (Lovaza) could improve mitochondrial function. From a mechanistic perspective, the~     investigators have observed in vitro that n-3 PUFAs accumulate predominately into the~     mitochondrial membrane of cardiomyocytes where the investigators believe they exert their~     effects on the biophysical organization of the membrane. Therefore, the CENTRAL HYPOTHESIS is~     that administering Lovaza to patients with severe MR will reduce apoptosis and improve~     mitochondrial function in LA (Aim 1). This change in mitochondrial function will be driven by~     significant biochemical and biophysical remodeling of the mitochondrial membrane (Aim 2).~   "
192351|NCT01046591|"~     The purpose of this study is to determine whether cleft palate repair increases the risk for~     obstructive sleep apnea in children and whether sleep apnea could explain learning and~     behavior difficulties that are often observed.~   "
192352|NCT01046578|"~     A single center, open label randomized clinical trial designed to examine ovarian follicular~     dynamics following attempted atresia induction during the late follicular and early luteal~     phase of the menstrual cycle using an aromatase inhibitor.~      We hypothesize that administration of an aromatase inhibitor (AI) at biologically important~     times of the natural menstrual cycle will cause ovulatory failure in women with preovulatory~     follicles and failure of luteogenesis in women who have recently ovulated. It is proposed~     that atresia of the dominant follicle and formation of anovulatory structures will be~     associated with arrested endometrial development and a shortened interval to menstrual~     bleeding (3 days). We anticipate that this will provide us with information to facilitate the~     development of a new method for emergency contraception and a greater understanding of human~     folliculogenesis.~      The rationale for the proposed research project is based on the ovarian synchronization~     concepts developed and documented in the bovine model in the Reproductive Science and~     Medicine Research group at the University of Saskatchewan combined with novel human ovarian~     wave concepts of folliculogenesis first elucidated in the Women's Health Imaging Research~     Laboratory (WHIRL) in the Department of Obstetrics, Gynecology and Reproductive Sciences.~   "
192353|NCT01046565|"~     The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1%~     to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3)~     weeks.~   "
192354|NCT01046552|"~     ERCP plays an important role in management of common bile duct stones. Herein the~     investigators compare preoperative against intraoperative ERCP.~      210 were included but only 198 patients were randomly divided into two groups; PES/LC (100~     patients) and LC/IOES (98 patients).~      The total hospital stay were significantly shorter in the group of LC/IOES~   "
192355|NCT01046539|"~     This is a single site, double-blind, randomized, placebo-controlled, crossover study to~     assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy,~     opioid-experienced, non-treatment-seeking subjects.~   "
192356|NCT01046526|"~     Background:~        -  Individuals who have schizophrenia are significantly more likely to smoke than the~          general population, which leads to increased smoking-related illnesses and high rates of~          nicotine dependence. Research suggests that high rates of smoking and nicotine addiction~          in people with schizophrenia are related to the fact that nicotine temporally improves~          performance in several cognitive tasks, including sensory gating, long-term memory, and~          visual tracking-all of which are affected by schizophrenia.~        -  Smoking among schizophrenia patients may be a form of self-medication, since nicotine~          may temporarily treat and improve cognitive deficits caused by schizophrenia.~          Researchers are interested in studying the effects of nicotine on the brain activity of~          individuals with schizophrenia to better understand how nicotine affects the brain~          regions connected to memory, visual tracking, and attention.~      Objectives:~        -  To identify specific brain regions involved in the anticipatory learning deficits found~          in schizophrenia patients who smoke.~        -  To determine whether and how nicotine enhances performance in these regions.~      Eligibility:~      - Smokers (at least 10 cigarettes per day) between 18 and 50 years of age who either are~     healthy volunteers or have been diagnosed with schizophrenia/schizoaffective disorder.~      Design:~        -  Participants will be asked to avoid consuming alcohol and restrict consuming caffeinated~          beverages for 24 hours before the study days. Participants will provide urine and breath~          samples at the start of the study to be tested for chemicals that may interfere with the~          study.~        -  The study will require two to four visits, with two fMRI sessions and other visits for a~          clinical interview or training.~      Participants will have a training session with a possible mock MRI scan to learn how to do~     tasks that track eye movement and measure ability to pay attention.~        -  During the fMRI scanning sessions, participants will receive either a nicotine patch or~          a placebo patch without nicotine. After the patch is in place, participants will perform~          tasks while receiving MRI scans. The scans will take up to 2 hours.~        -  Participants will provide blood samples after finishing the MRI sessions.~   "
192357|NCT01046513|"~     Background:~      - Central nicotinic acetylcholine receptors (nAChRs) are the primary target for the action of~     nicotine. In addition to being involved in tobacco dependence, they are also involved in a~     variety of brain disorders, including Alzheimer's and Parkinson's diseases. Researchers are~     interested in developing better ways to study the action of nAChRs to improve treatments for~     smoking cessation and other problems affected by these receptors. These new study methods may~     involve different radiotracers, which are drugs that can help show brain activity during~     positron emission tomography (PET) scanning.~      Objectives:~      - To evaluate the feasibility of using a radiotracer, 2-[18F]F-A-85380, in PET scanning of~     the brain.~      Eligibility:~      - Healthy volunteers between 21 and 45 years of age who do not use tobacco.~      Design:~        -  Participants will be asked to avoid consuming alcohol or using a number of~          over-the-counter medications, including antihistamines, cough medicines, and nasal~          decongestants, for 5 days before the study day. Participants provide urine and breath~          samples at the start of the study to be tested for chemicals that may interfere with the~          study.~        -  Participants will visit the clinical center the morning of the day before the scanning~          session to provide blood and urine samples as required. Participants will return and be~          admitted for an overnight stay later that afternoon or evening.~        -  On the day of the study, participants will receive a single dose of the radiotracer~          2-[18F]F-A-85380, and will have a series of PET scans over the next 7 hours and provide~          blood samples during that time. Participants will spend that night at the clinical~          center and leave on the morning after the end of the study.~        -  Participants will return for follow-up visits 2 weeks and 1 month after the end of the~          study.~   "
192360|NCT01046474|"~     The main objective is to evaluate the effect on BMI of a school-based program that~     discourages the consumption of all sweetened beverages, encourages the reduction in sugar~     intake, and encourages the increase in physical activity among adolescents and their families~     from a low socioeconomic area.~   "
198754|NCT00961324|"~     This trial is conducted in Europe. The aim of this clinical trial is to evaluate the~     variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects~     with type 1 diabetes.~   "
192361|NCT01046461|"~     Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result~     in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in~     acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when~     coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis.~     Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and~     tolerability and a longer duration of effect than granisetron in preventing acute vomiting in~     patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in~     84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase~     emesis was less than 60%.~      Aprepitant is a selective, high-affinity NK1 receptor antagonist. Adding aprepitant to 5-HT3~     receptor antagonists and steroid improve CR rate of not only chemotherapy induced acute~     emesis and but also delayed emesis by 11-14 and 20 percentage points, respectively.~      But until now, there was no information that which 5-HT3 receptor antagonists is the best~     partner for aprepitant. Therefore, we initiated a prospective, open-label, phase II study to~     assess the efficacy and tolerability of a combination of ramosetron, aprepitant and~     dexamethasone (RAD) in the prevention of cisplatin based CINV in chemotherapy-naïve patients~     with solid cancer~   "
192362|NCT01046448|"~     Children and adolescents with chronic kidney disease (CKD) are at high risk for~     cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients~     with even moderately impaired kidney function may be afflicted with significant early cardiac~     and vascular abnormalities.~      The pathogenesis and the natural course of CV comorbidity in pediatric CKD patients is still~     elusive. In this multicenter, prospective, observational study the prevalence, degree and~     progression of CV comorbidity in children will be characterized and related to CKD~     progression. The morphology and function of the heart and vessels will be monitored by~     sensitive, non-invasive methods and will be compared with aged matched healthy controls.~     Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors~     will be monitored prospectively and will be related to CV status. Genotyping might identify~     predisposing genetic factors for progression of CV comorbidity and underlying nephropathies.~   "
192363|NCT01046435|"~     The purpose of this study is to determine if treating periodontal infections (gum disease)~     will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.~   "
192364|NCT01046422|"~     The purpose of this study is to determine if BMS-770767 is safe, well tolerated, measure its~     levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that~     may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population~   "
192365|NCT01046409|"~     The purpose of this trial is~        1. to compare the clinical significance of the main vessel and the side branch vessel using~          EKG, pain score and coronary wedge pressure~        2. to develop a new scoring system to predict the clinical significance of a side branch~   "
192366|NCT01046396|"~     The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1%~     to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3)~     weeks.~   "
192367|NCT01046383|"~     The primary aim of this IMN 1207 follow-up study is to confirm the effect of a cysteine-rich~     non-denatured whey protein isolate formulation IMN1207 (20g daily) versus casein (20 g daily)~     on the reversal of weight loss (cancer-related wasting) over a 40 week treatment period in~     non-small cell lung cancer patients with or without conventional therapy, i.e., chemotherapy~     or radiation. And to test the hypothesis that over a period of 66 weeks observation period~     which includes a 6 months follow-up period, increases the survival of these patients.~   "
192368|NCT01046370|"~     The purpose of this pilot study is to gather preliminary data on the efficacy and feasibility~     of the Amygdala Retraining Program (ARP), a mind-body practice versus a control (C) on~     fatigue, quality of life and sleep in patients with Chronic Fatigue Syndrome (CFS), Chronic~     Fatigue (CF) and Fibromyalgia (FM).~      CFS, CF and FM are incapacitating disorders characterized by profound fatigue, muscle pain,~     impaired memory, insomnia, and post-exertional malaise (Fukuda 1994). Current literature~     points to a centrally sensitized state in CFS, CF and FM (Meeus 2007). The ARP attempts to~     retrain this neuronal network through mind-body practices such as cognitive restructuring via~     neurolinguistic programming, yoga based breathing and simple mindfulness based meditation. A~     case series of 33 patients with CFS and ARP reported improvement in 92% of patients with~     two-thirds of patients reaching 80-100% of pre-illness levels of health (Gupta 2009). However~     ARP has never been formally studied in CFS.~      We propose to gather preliminary data on the efficacy and feasibility of ARP versus C on~     fatigue, quality of life and sleep in 30 patients with CFS, CF and FM. All participants will~     undergo standard clinical treatment which consist of a 2 day self-management program in the~     Chronic Fatigue Clinic. Following this, participants will be randomized into the ARP or C~     group. The ARP group will receive an additional 2.5 hour training surrounding core concepts~     of the ARP program. They will then be given the ARP DVD program and booklet, to reinforce and~     continue the practice. They will then receive scheduled bi-monthly phone calls for 3 months~     from a study investigator for support. The C group will receive only standard care. However~     they will receive a complementary copy of the ARP program at the end of the study (6 month~     time point) as a gift for participation in the study.~      Preliminary data on efficacy will be assessed at baseline, 1, 3 and 6 months using the~     following validated questionnaires: Multidimensional Fatigue Inventory (MDFI), Short form-36~     (SF36) Fibromyalgia Impact Questionnaire (FIQ), Epworth Sleep Scale (ESS) and Measure Your~     Medical Outcome Profile (MYMOP-2). Feasibility will be assessed by evaluation of a daily~     practice log where patients record the total time spent daily in the practice of ARP and any~     specific difficulties they encountered in the practice of the program.~   "
192369|NCT01046357|"~     This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single~     ascending dose study in healthy male volunteers conducted at a single centre. The effect of~     food on the pharmacokinetics of AZD7687 will also be studied.~      The study will consist of two parts, a dose escalation part and a food interaction part. The~     two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different~     panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation.~     Each subject will receive dose only once, except for the volunteers included in the dose~     steps repeated for food interaction.~   "
192370|NCT01046331|"~     The demographic characteristics, clinical features, course, and outcomes of severe H1N1~     influenza infection requiring intensive care have not been defined rigorously and~     systematically. While the majority of patients in early reports of critically ill novel~     influenza A (H1N1) have respiratory involvement, up to 10-20% may present with~     non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden~     of disease and resource utilization of these patients remains largely unknown. The purpose of~     this surveillance registry is to characterize the demographics, clinical features, outcomes,~     and resource utilization of patients with H1N1 influenza infection who require intensive~     care.~   "
192371|NCT01046318|"~     The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in~     patients with type 2 diabetes by repeated administration orally for 52 weeks.~   "
192372|NCT01046305|"~     Objectives:~      The objective of this study is to measure and delineate the symptom burden experienced by~     patients with chronic myeloid leukemia (CML).~      The Primary Aim is to develop and validate an M. D. Anderson Symptom Inventory (MDASI) module~     (the MDASI-CML), compliant with FDA standards for patient-reported outcomes (PROs), to~     measure the severity of multiple symptoms and the impact of these symptoms on daily~     functioning in patients with CML.~      The Secondary Aims are:~        1. to develop a detailed description of the severity and interference with daily activities~          of symptoms experienced by patients with CML;~        2. to assess the impact of symptom severity in CML on standard functioning and quality of~          life (QOL) measures including Eastern Cooperative Oncology Group (ECOG) Performance~          Status and single-item QOL scale;~        3. to evaluate the MDASI-CML as an estimate of functional status and QOL in patients with~          CML;~        4. to identify common clusters of symptoms and symptom patterns occurring over multiple~          measurement time points in patients with CML;~      5, to define the qualitative symptom burden of patients with CML;~      6. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring~     symptom severity and interference with daily activities over time in patients with CML.~   "
192373|NCT01046292|"~     The aim of this study is to evaluate the effects of Ginkgo Biloba Extract (GBE) in executive~     function-impaired Mild Cognitive Impairment (MCI) patients by assessing gait while walking~     alone as well as under differing dual-task conditions.~      The primary endpoint in the evaluation of GBE efficacy is gait speed. The secondary endpoint~     is cycle time variability under dual-task conditions.~   "
192374|NCT01046279|"~     Prospective casecontrol study in glioma patients undergoing treatment with bevacizumab~     (Avastin). At present there are no data on the correlation between occurrence of arterial~     hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. We will~     investigate whether glioma patients developing hypertension under bevacizumab treatment have~     a better outcome in terms of progression free survival, response rate and overall survival~     than equally treated patients remaining normotensive. Moreover, we will describe the dynamics~     of change in blood pressure after administration of bevacizumab in those patients developing~     hypertension.~        -  Trial with medicinal product~   "
192375|NCT01046266|"~     This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as~     compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will~     receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study~     treatment is up to 3 months, and target sample size is <50.~   "
192376|NCT01046253|"~     The object of this study is to compare the relative bioavailability of lansoprazole 30 mg~     delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and~     distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP~     Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions with dosing by~     applesauce-sprinkle method.~   "
192377|NCT01046240|"~     This trial compares the pharmacokinetics of palonosetron administered subcutaneously and~     intravenously.~   "
192378|NCT01046227|"~     The patients of pediatric haemato-oncology have a higher risk for novel H1N1 influenza~     infection than general population, and they are strongly recommended to receive novel H1N1~     vaccination. However, there is no previous data to answer how the efficacy and effectiveness~     of novel H1N1 vaccination is in patients of pediatric haemato-oncology. This study is~     designed to investigate the antibodies titers before and after the novel H1N1 influenza~     vaccination in these patients. Titer of H1N1 influenza virus antibodies will be determined by~     hemagglutinin inhibition assay (HAI). A HAI titer with a 4-fold rise or greater is defined as~     seroconversion. Study subjects with seroconversion are regarded as responsiveness to the~     vaccination. Meanwhile, if the patient presents influenza-like symptoms, we will perform~     throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza~     PCR to confirm the diagnosis. After the study, we will be able to know whether or not current~     novel H1N1 influenza vaccination schedule is adequate and efficient for pediatric~     haemato-oncology patients.~   "
192379|NCT01046214|"~     The objective of this study is to evaluate the comparative bioavailability between bupropion~     hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL®~     300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients~     under fasting conditions.~   "
192380|NCT01046201|"~     The Pediatric Obesity Research Registry will function to collect and catalog historical and~     medical chart related clinical data of patients presenting with pediatric obesity and who~     agree to participate.~   "
192381|NCT01046188|"~     The purpose of this study is to evaluate an interactive web-based teaching tool in IVF~     patients. Patients will be randomized to participate in web-based IVF teaching or a didactic~     lecture. A knowledge questionnaire will be completed both prior to and following the teaching~     intervention. Both groups will also complete stress and satisfaction surveys throughout the~     IVF treatment cycle. Groups will be compared at the completion of the study for demographics,~     level of knowledge, stress and satisfaction. The web-based group will be evaluated for web~     usage.~   "
192382|NCT01046175|"~     Respiratory complications continue to be one of the leading causes of morbidity and mortality~     in people with spinal cord injury, especially among cervical and higher thoracic injuries.~     Both inspiratory and expiratory function are often severely decreased, leading to respiratory~     complications, such as atelectasis, pneumonia and ventilatory failure. The prevention of~     these respiratory complications needs to begin immediately after injury. To achieve effective~     expelling of secretions before they form mucus plugs, it is essential to improve patients~     ability to cough. Manually assisting the cough is one way of increasing cough flow, but an~     effective cough also requires adequate lung volumes. The emphasis should therefore be on~     expansion of the lungs before coughing. One way of expanding the lungs is by air-stacking. In~     air-stacking insufflations are stacked in the lungs to maximally expand them. Cough can be~     valued by measuring Peak Cough Flow (PCF). By combining air-stacking with manually assisted~     cough the PCF can be increased sufficiently. The aim of this study is to compare the effect~     of two different air-stacking techniques on PCF, air-stacking on a respirator versus~     air-stacking with a manual resuscitator.~   "
192383|NCT01046162|"~     The purpose of this study is to compare bioavailability between formulations of alprazolam in~     tablets to determine their bioequivalence in terms of rate and magnitude of absorption.~   "
192384|NCT01046149|"~     The specific aims of this study are:~        1. To develop a breathing training protocol specifically designed to improve HRV and~          psychosocial functioning for postmenopausal women with depressive symptoms,~        2. To examine the immediate effects of an 8-week breathing training program on HRV and~          psychosocial end points in postmenopausal women with depressive symptoms,~        3. To examine the intermediate-term effects of an 8-week breathing training program on HRV~          and psychosocial end points in postmenopausal women with depressive symptoms, and~        4. To determine whether the change in depressive symptoms with breathing training in~          postmenopausal women is associated with the change in HRV.~   "
192385|NCT01046136|"~     This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex~     in patients with colds. Patients will receive 7 days of treatment with either Mucinex or~     placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.~   "
192386|NCT01046123|"~     Radiotherapy to the whole brain is standard treatment for cancer that has spread to the brain~     (brain metastases) as it treats both the metastases that can be seen on scans and the brain~     metastases that are too small to be seen on scans.~      This study will use a novel radiotherapy technique, called volumetric modulated arc therapy~     (VMAT), to treat patients with brain metastases. This technique allows delivery of both a~     standard radiation dose to the whole brain as well as a higher radiation dose to the brain~     metastases at the same time.~      The study will assess the effectiveness of using VMAT in treating brain metastases, and~     examine its potential side-effects.~   "
192387|NCT01046110|"~     This trial will be conducted in Africa, Asia, North America and South America. The aim of~     this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to~     subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes~     inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).~   "
192388|NCT01046097|"~     The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™~     when administered according to the local Prescribing Information to healthy Filipino infants.~   "
192389|NCT01046084|"~     The object of this study is to compare the relative bioavailability of lansoprazole 30 mg~     delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and~     distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP~     Pharmaceuticals, Inc.) in healthy, adult, subjects under non-fasting conditions.~   "
192390|NCT01046071|"~     The purpose of this study is to determine whether Transversus abdominis plane block as part~     of a multimodal postoperative regimen is superior to control in analgesic efficacy after~     laparoscopic cholecystectomy.~   "
192391|NCT01046058|"~     The purpose of the study is to investigate the effect of moderate and severe hepatic~     impairment on the pharmacokinetics of TMC435. Pharmacokinetics means how the drug is absorbed~     into the bloodstream, distributed in the body and eliminated from the body. In addition, the~     short-term safety and tolerability of TMC435 in participants with hepatic impairment will be~     determined. The results of this study will guide dose recommendations for TMC435 in patients~     with impaired liver function.~   "
192392|NCT01046045|"~     Despite the remarkable improvement in short-term patient and graft survival among the~     recipients of kidney transplants, the progressive renal dysfunction (chronic allograft~     dysfunction) accompanied by chronic interstitial fibrosis, tubular atrophy, vascular~     occlusive changes and glomerulosclerosis remains the chief cause of graft loss. As a result~     of this damage from immunologic and non-immunologic injury, the long-term survival of kidney~     transplants has changed little during the past decade. And, among the non-immunologic~     factors, calcineurin inhibitor nephrotoxicity has been shown to be the most common factor~     leading to long-term graft damage and progression to graft failure. This is further supported~     by the previous finding that long-term use of calcineurin inhibitor-based therapy leads to~     deterioration in kidney function, even in recipients of non-renal organ transplants.~      The growing interest in calcineurin inhibitor minimisation protocols to optimize renal~     transplant outcome offers a new therapeutic options in the management of patients with~     chronic allograft dysfunction. Recently, mammalian target-of-rapamycin inhibitors (mTOR~     inhibitors) including everolimus has been shown to achieve an improvement of long-term~     function through an early modulation of immunosuppressive regimen. In this aspect,~     percutaneous renal graft biopsy represents an important diagnostic tool to allow~     visualization of the lesions of chronic allograft dysfunction and therefore the ability to~     delineate the potential improvement after introduction of everolimus. Histologic and~     morphometric findings from a protocol-mandated biopsies obtained from renal transplant~     recipients who are suffering from chronic allograft dysfunction and treated with everolimus~     are needed to provide a clinical blueprint for the drug's efficacy, if confirmed.~   "
192393|NCT01046032|"~     The aim of study was to investigate whether pre-treatment with metformin before and during~     IVF increases the live birth rate compared to placebo in women with sonographic evidence of~     polycystic ovaries (PCO), but without any clinical manifestations of polycystic ovary~     syndrome (PCOS).~   "
192394|NCT01046019|"~     Research with DXA has shown the pattern of bone remodelling around an implant. The baseline~     and reference value for such calculations is the first measurement after the operation. The~     baseline measurement is performed at different time from study to study. If there is a rapid~     bone loss the first weeks after an operation, this will influence the reference value and~     then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA~     measurements within the first 2 weeks. Our hypothesis is that there is a rapid bone loss the~     first 2 weeks after operation and that timing of the first post operative measurement will~     influence the later results.~   "
192409|NCT01045824|"~     The goal of this research is to find out possible susceptible gene(s) in schizophrenic~     patients with family history and 5-year period functional changes of brain among the members~     of family, in order to further analysis factors and their interactions.~   "
192515|NCT01044446|"~     The objective of the present study is to evaluate the a prior hypothesis that treatment with~     icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis~     complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing~     glucose exposure, extent and severity of peritonitis will be evaluated in the setting of~     acute peritonitis complicating peritoneal dialysis among patients who are not receiving~     icodextrin.~   "
198755|NCT00961311|"~     Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend~     1.25 mm angioplasty balloon.~   "
192395|NCT01046006|"~     Rituximab is a monoclonal antibody with proven efficacy in WM but responses are slow.~     Bortezomib has shown significant and rapid activity in WM. Combinations of bortezomib with~     rituximab nad dexamethasone with rituximab have shown synergistic activity in laboratory~     studies and clinical trials. This is a Phase II multicenter study designed to evaluate the~     safety and efficacy of the combination of Bortezomib , Rituximab and dexamethasone (BDR). BDR~     will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles~     to patients with WM. Bortezomib will be administered as an iv push over 3 to 5 seconds at a~     dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1. On cycles 2-5 bortezomib will be given~     at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5,~     following the administration of Bortezomib, dexamethasone 40mg iv and Rituximab 375 mg/m2 iv~     will be administered. A total of 8 infusions of rituximab will be administered. Subsequently~     patients rated as CR, PR, MR or SD will be followed without any treatment until there is~     evidence of progressive disease.~   "
192396|NCT01045993|"~     The study is designed to assess methods used in clinical research.~   "
192397|NCT01045980|"~     The main purpose of this study is to compare the effects of using bio-impedance analysis to~     guide management of fluid status versus routine clinical care on heart structure. In~     addition, Vitamin D is being assessed to determine its effect on heart structure.~   "
192398|NCT01045967|"~     The object of this study is to compare the relative bioavailability of lansoprazole 30 mg~     delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and~     distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP~     Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions.~   "
192399|NCT01045954|"~     This study will be conducted in subjects with Type 1 diabetes mellitus on multiple daily~     insulin injections to determine the correct insulin dosing formulas. Subjects will be~     evaluated using continuous glucose monitoring.~   "
192400|NCT01045941|"~     We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and~     significantly reduces the chances of postoperative wound breakdown. This will shorten the~     wait time required to begin adjuvant therapy to one week after surgery thereby combating the~     micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer~     will therefore improve along with decreasing the incidence of locoregional recurrence.~   "
192401|NCT01045928|"~     RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab~     may be an effective treatment for B-cell non-Hodgkin lymphoma.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide~     when given together with rituximab as maintenance therapy in treating patients with B-cell~     non-Hodgkin lymphoma.~   "
192402|NCT01045915|"~     The objective of the present trial is to evaluate the local and general safety of the~     intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from~     advanced or metastatic melanoma and to identify doses that could be effective on cutaneous~     lesions in man.~   "
192403|NCT01045902|"~     The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in~     comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration~     pneumonia.~   "
192404|NCT01045889|"~     The purpose of the study is to evaluate the efficacy of an intensified first-line treatment,~     with conventional chemotherapy (CHOP) plus monoclonal antibody anti CD20, followed by high~     dose chemotherapy and PBSC transplantation in HIV-related aggressive non-Hodgkin lymphoma at~     high risk , according to the international prognostic index (IPI).~   "
192405|NCT01045876|"~     Many drugs are used to prevent nausea and vomiting and pain after surgery. In this study the~     investigators will be looking at a drug, dexamethasone, which is commonly used to prevent~     nausea and vomiting and pain after surgery but has other side effects. Dexamethasone is a~     man-made drug that is commonly used during surgery but also can affect naturally occuring~     hormones. In this study the investigators will be looking at dexamethasone's effect on a~     number of naturally occuring hormones over a twenty four hour period after thyroid surgery.~     The investigators hypothesize that plasma cortisol levels will be decreased following~     administration of dexamethasone.~   "
192406|NCT01045863|"~     The purpose of this study is to evaluate safety and tolerability after a single~     administration of PF-03382792 in healthy volunteers.; and to evaluate plasma drug levels and~     biological activity.~   "
192407|NCT01045850|"~     Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and~     hemorrhagic events associated with perioperative management of antiplatelet agents. Several~     guidelines have outlined the importance of maintaining antiplatelet agents throughout~     surgical procedures to prevent cardiovascular complications. On the other hand, interruption~     of antiplatelet agents is still a usual standard to avoid surgical complications. We~     investigate the impact of perioperative antiplatelet drugs management on these complications,~     through a multicenter, prospective cohort (RECO stands for Registre des patients porteurs~     d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque), including all patients with~     coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study~     is primarily to measure the incidence of cardiovascular (including stent thrombosis) and~     hemorrhagic complications and to identify pre and postoperative risk factors associated with~     these complications.~   "
192408|NCT01045837|"~     Withdrawal of gluten, the culprit antigen, is the definite treatment for celiac disease.~     Weeks to months after gluten withdrawal from the diet before the clinical manifestations,~     histological features start improving. Many of the adult patients are in the critical phase~     where even weeks may matter especially those in their adolescence where height growth has~     limited potential.~      Suppression of immune system using a short course of steroid might retard the immune mediated~     destruction of the villi while the effect of gluten withdrawal sets in. Steroids are known to~     be effective in the management of refractory celiac disease. Therefore, the investigators~     hypothesized that addition of a short course of steroid to gluten free diet may enhance~     intestinal mucosal recovery and thus clinical manifestations~   "
198799|NCT00960726|"~     The goal of this clinical research study is to learn if NOV-002 can help to restore bone~     marrow and blood levels in patients who have MDS. The safety of this drug will also be~     studied.~   "
192410|NCT01045811|"~     The specific aims of this study are:~        1. To develop a breathing training protocol specifically designed to improve HRV and~          psychosocial functioning for postmenopausal women with depressive symptoms,~        2. To examine the immediate effects of an 8-week breathing training program on HRV and~          psychosocial end points in postmenopausal women with depressive symptoms,~        3. To examine the intermediate-term effects of an 8-week breathing training program on HRV~          and psychosocial end points in postmenopausal women with depressive symptoms, and~        4. To determine whether the change in depressive symptoms with breathing training in~          postmenopausal women is associated with the change in HRV.~   "
192411|NCT01045798|"~     This is a pilot feasibility study that investigates antifungal therapy with caspofungin in~     patients at high-risk for developing invasive candidiasis in a critical care setting.~   "
192412|NCT01045785|"~     The purpose of this study is to determine whether aspirin resistance has impact on~     cardiovascular event in dialysis patient.~   "
192413|NCT01045772|"~     This is a single-center open label study of the IL-1 transfusion protein rilonacept in~     subjects with Muckle-Wells syndrome (MWS), or Schnitzler syndrome (SchS) in Germany.~     Prospective subjects will be recruited from a patient population previously characterized in~     an observational study, and from referrals within the German CAPS community; SchS subjects~     will be recruited through the Charité Patient pool.~      The Baseline phase will begin with the Screening visit (day -21 = Visit 1) and continue for~     three weeks; DHAFs (Daily Health Assessment Forms) will be collected from all subjects from~     Day - 21 to Day 0. DHAF information including MWAS (Muckle-Wells Activity Score), or SCHAS~     (Schnitzler Activity Score) values from this period will be used for the baseline phase~     evaluation. Inclusion to receive rilonacept will occur on day 0 (= Visit 2).~      On day 0 eligible subjects will receive a loading dose of two subcutaneous (S.C.) injections~     of rilonacept for a total of 320 mg. Subsequent study drug injections of rilonacept 160 mg~     will be administered once a week for four weeks. After subjects complete this initial 4-week~     treatment phase, they will be eligible to receive rilonacept 160 mg once weekly for 48 weeks~     during the extended treatment phase.~      DHAFs will be used to assess symptoms throughout the study. Overall a max. of 12 subjects~     with either MWS or SchS will be enrolled.~   "
192414|NCT01045759|"~     We propose an observational study to assess the ability of intensivists to evaluate for deep~     vein thrombosis using 2 point compression ultrasonography.~   "
192415|NCT01045746|"~     The goal of this pilot study is to test whether in the elderly population there are acute~     long-term improvements in both the static and dynamic balance, reaction time and mobility~     with the use of WBV.~   "
192416|NCT01045733|"~     The purpose of this study was to evaluate and compare postoperative corneal aberrations and~     visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular~     lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.~   "
192417|NCT01045720|"~     The goal of this research is hoping to combine traditional Chinese medicine medication and~     find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication~     compliance, improving life quality, improving social-function and reducing neopathy.~   "
192418|NCT01045707|"~     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of~     this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart~     (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with~     metformin + at least one OAD (oral anti-diabetic drug).~      The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension~     period is registered as NN5401-3726.~   "
192419|NCT01045694|"~     Basal arthritis of the thumb is a common condition with increased prevalence in~     post-menopausal women, obese persons, and the elderly. Surgical options are varied and~     efficacious, but not all patients are candidates for surgery. The successes and pitfalls of~     previous, similar trials are carefully considered in the creation of our own. Though steroid~     injection is the standard of care in basal joint arthritis, current data does not support its~     efficacy beyond placebo effect. No trial has yet examined the efficacy of botulinum toxin~     type A (BTX-A) injection into the basal thumb joint nor compared it to steroid. Since~     efficacy of steroid is questionable at best, our hope is that BTX-A injection of the basal~     joint might be the next great tool in treating this common, debilitating disease.~   "
192420|NCT01045681|"~     The present trial is designed as a phase II study that aims at estimating the efficacy of the~     combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory multiple~     myeloma (MM). The response rate, i.e. the rate of the patients achieving a Complete Response~     or Partial Response at cycle 4, divided by the total intent to treat patient number is chosen~     as primary efficacy endpoint.~      The estimation of the efficacy rate is to be based on an explorative pilot study, since~     immediate embarking on a large-scale comparative efficacy trial would not be acceptable from~     the point of view of resources. Moreover, this would induce ethical objections, as it does~     not seem to be justifiable to expose a large number of patients to an experimental approach~     without sufficient exploratory indications of an improved risk-benefit ratio.~   "
192421|NCT01045668|"~     This study aims to assess whether a combined technique of substrate ablation and ablation of~     the clinically presenting VT at the site of early activation is superior to ablation of the~     clinically presenting VT alone, in enhancing long-term success of VT ablation.~   "
192422|NCT01045655|"~     The study will evaluate the effectiveness of a culturally relevant, multi-component~     intervention for antenatal depression. The intervention includes an engagement session, and~     the woman's choice of brief interpersonal psychotherapy and/or pharmacotherapy in a stepped~     care treatment for depression model.~   "
192423|NCT01045642|"~     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,~     crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr. Reddy's~     Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets) of~     Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fasting~     conditions.~   "
192424|NCT01045629|"~     The goal of this research is to understand whether schizophrenic patients are capable of~     comprehending clinical trial consent form or influenced by disease, also after intensified~     educational illustration for understanding of consent form, their comprehension increased~     or not, in order to protect patient's right.~   "
192425|NCT01045616|"~     Children born with very low birth weight and extremely low birth weight are at increased risk~     of various ophthalmic challenges such as retinopathy of prematurity (ROP), refractive error,~     strabismus, cerebral visual impairment, colour vision deficits, reduced contrast sensitivity~     (CS), visual field defects, and decreased visual acuity (VA). Many of these factors are not~     independent of each other. Among them, refractive error is a really common disorder. These~     can cause significant disability which can impact life's activities and, qualities.~     Currently, no standard guidelines are available toward the provision of ophthalmic follow up~     care for preterm infants. It is important to survey the prevalence of different ophthalmic~     sequelae in Taiwan, to identify the risk factors of developing these sequelae, and,~     furthermore, to build up a screening program. The preterm population has heterogeneous~     conditions to developing ophthalmic sequelae. National Taiwan University Hospital (NTUH) is~     now in charge of a big part of intense care for these low birth weight preterm neonates. With~     detailed medical record done of these children during care in the neonatal unit, we are~     competence for this meaningful program.~   "
192426|NCT01045603|"~     The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the~     treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and~     distribution of dose strength. Data will be collected at three different time points over a 3~     month period.~   "
192427|NCT01045590|"~     Rationale Rosiglitazone and troglitazone both promote differentiation of pre-adipocytes into~     adipocytes in subcutaneous, but not omental fat, and reduce gamma glutamyl transferase, a~     surrogate marker for intra-abdominal and hepatic fat. Troglitazone has been shown by~     abdominal computed tomography (CT) and magnetic resonance imaging (MRI) scan to reduce the~     intra-abdominal adipose tissue area in type 2 diabetics. Similarly rosiglitazone has also~     been shown to increase subcutaneous but not intra-abdominal fat in patients with type 2~     diabetes. In the same study it was also shown to cause a substantial reduction in hepatic~     fat. Central fat depots are believed to be associated with more cardiovascular risk than~     subcutaneous fat depots. By contrast, sulphonylurea-associated weight gain has been shown by~     abdominal CT scan to include increases in intra-abdominal adipose tissue.~      The aim of this study is to compare the body fat distribution pattern of glibenclamide plus~     rosiglitazone versus glibenclamide and placebo (especially the intra-abdominal adipose tissue~     and abdominal subcutaneous adipose tissue areas) in patients with type 2 diabetes. It is~     hypothesised that rosiglitazone will lead to the accumulation of excess energy stores in the~     subcutaneous rather than the intra-abdominal adipose tissue depot. In addition, it is hoped~     that by having a positive effect on diastolic blood pressure, lipid levels, BMI,~     rosiglitazone will be shown to have a better cardiovascular risk profile when used in~     combination with glibenclamide rather than when glibenclamide is used alone.~      Although insulin resistance has been shown to be a primary defect causing type 2 diabetes~     mellitus, insulin secretory defect has also been known to be an important factor in the~     development of type 2 diabetes mellitus. A previous study has shown that in Korean patients,~     early-phase insulin secretory defect may be the initial abnormality in the development of~     type 2 diabetes mellitus [56].~      This study also aims to assess the efficacy and safety of glibenclamide plus rosiglitazone~     versus glibenclamide plus placebo therapy in Korean patients with type 2 diabetes. In~     addition, a previous study has shown that in Korean patients, early-phase insulin secretory~     defect may be the initial abnormality in the development of type 2 diabetes mellitus. This~     study aims to show that rosiglitazone treatment in Korean patients, regardless of their early~     phase insulin secretory ability, is just as efficacious and safe.~      Objective(s) Primary To evaluate the effect of 12 months oral treatment with glibenclamide~     plus rosiglitazone versus oral glibenclamide plus placebo, on body fat distribution (as~     measured by the change in the ratio between the intra-abdominal adipose tissue and abdominal~     subcutaneous adipose tissue areas) in patients with type 2 diabetes.~      Secondary~        -  To investigate the efficacy of glibenclamide plus rosiglitazone, compared to~          glibenclamide plus placebo on beta-cell function and insulin resistance as calculated by~          HOMA-B and HOMA-R.~        -  To investigate the efficacy of glibenclamide plus rosiglitazone, compared to~          glibenclamide plus placebo on fasting plasma glucose, insulin, fasting serum lipid~          profile (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol and total~          cholesterol to HDL cholesterol ratio).~        -  To investigate the efficacy of glibenclamide plus rosiglitazone, compared to~          glibenclamide plus placebo on early phase insulin secretion during an oral glucose~          tolerance test as measured by the insulinogenic index.~        -  To define further the clinical safety and tolerability of glibenclamide plus~          rosiglitazone through the assessment of physical examinations, vital signs, weight,~          routine laboratory tests, adverse experiences and electrocardiograms (ECGs).~      Endpoint(s) Primary Change from baseline in the ratio (IAAT:SAT) between the intra-abdominal~     adipose tissue area (IAAT) and abdominal subcutaneous adipose tissue area [SAT] after 12~     months treatment with oral glibenclamide plus rosiglitazone compared to oral glibenclamide~     plus placebo Secondary~      Comparisons will be made between glibenclamide plus rosiglitazone and glibenclamide plus~     placebo treatment groups on Change from baseline after 6 and 12 months treatment with respect~     the following:~      CT Scan~      Derived from CT image at the lumbar IV level:~        -  abdominal subcutaneous adipose tissue area [SAT]~        -  intra-abdominal adipose tissue area [IAAT]~      Derived from the CT image of the right leg at the thigh level (1cm below the gluteal fold):~        -  total subcutaneous adipose tissue area [TSAT] Derived from CT images at the lumbar IV~          and thigh level~        -  ratio between abdominal subcutaneous adipose tissue area [SAT] and total subcutaneous~          adipose tissue area of the thigh [TSAT]~        -  ratio between intra-abdominal adipose tissue area [IAAT] and total subcutaneous adipose~          tissue area of the thigh [TSAT] Derived from Oral Glucose Tolerance Test, glycaemic~          response to OGTT, difference~   "
192428|NCT01045577|"~     A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity~     of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis~   "
192429|NCT01045564|"~     The purpose of this study is to characterize the immunogenicity and safety of 3 doses of~     GSK's avian flu vaccine GSK 1557484A given at different time intervals to adults aged 18~     years or greater who are at increased occupational risk of H5N1 exposure.~   "
192430|NCT01045551|"~     Rosacea is a chronic skin disorder with the signs and symptoms of facial flushing, persistent~     redness, small visible spider-like veins, papules (inflamed red bumps under the skin) and~     pustules. Rosacea is also a a recurring skin disorder. In addition to causing uncomfortable~     and embarrassing physical symptoms such as flushing, burning, and itching, rosacea can also~     contribute to lower self-esteem, which can have a significant psychosocial impact on quality~     of life. Rosacea flares can be triggered by every day factors such as sun exposure, heat, hot~     or caffeinated drinks, alcoholic beverages, spices and stress.~      Many of the currently available treatments for rosacea are only partially effective and some~     patients do not respond to them, or are unable to tolerate the side effects.~      This is a single-center, open label trial of Apremilast in ten (10) subjects with moderate to~     severe inflammatory rosacea who will be treated with Apremilast 20 mg twice per day for 12~     weeks. Following the screening period and baseline visit, study subjects will return at weeks~     1, 2, 4, 6, 8, 10 and 12. There is a follow up study visit at week 16.~      Recent research has shown an increase of specific proinflammatory cytokines in the biopsies~     of inflammatory lesions from rosacea and acne patients. The cytokines then trigger a chain of~     chemical responses in the body that likely result in the development of the papules an~     pustules that are seen in rosacea and acne patients. Apremilast is an oral agent that~     modulates multiple anti-inflammatory pathways and has pharmacodynamic properties with~     potential therapeutic benefit for treating inflammatory autoimmune disorders.~      The investigators therefore propose a pilot study to evaluate the potential for Apremilast to~     improve the signs and symptoms of moderate to severe inflammatory rosacea.~   "
192431|NCT01045538|"~     There is scientific rationale for exploring the role of vorinostat, histone deacetylase~     inhibitor with capecitabine (X) and cisplatin (P), one of standard chemotherapy in patients~     with advanced gastric cancer. XP is a new standard of care in advanced gastric cancer (AGC)~     and vorinostat is a novel targeted agent that prevents tumor cell proliferation, survival and~     angiogenesis through histone deacetylase inhibition.~   "
192432|NCT01045525|"~     Insulin resistance-associated hepatic iron overload (IR-HIO), also defined as dysmetabolic~     iron overload syndrome or dysmetabolic liversiderosis, is a common cause or iron overload in~     France, mainly in middle-age patients with increased serum ferritin levels associated with~     normal serum transferrin saturation, and normal serum iron concentration in the absence of~     other known cause of increased serum ferritin levels.~      Treatment includes a combination of dietary measures and physical activity to correct~     metabolic disorders. Phlebotomies seem to be beneficial when serum ferritin level is high.~      This study aims at comparing the effect of iron depletion (by phlebotomy) plus lifestyle and~     diet advices versus lifestyle and diet advices alone on blood glucose level and insulin~     sensitivity in subjects with IR-HIO in order to assess the benefits of phlebotomies on the~     reduction of risk of diabetes and cardiovascular associated complications.~   "
192433|NCT01045512|"~     In the elderly a chronic basal systemic inflammation prevails - which is evident by enhanced~     CRP or IL-6 plasma concentrations - and by compromised defense mechanisms against invading~     microbes. These alterations belong to the physiological ageing process of the immune system~     (immunosenescence) and are regarded as an inflammatory response towards lifelong antigen~     stress (inflammatory/pathogen burden). This lifelong antigen stress evokes an age-dependent~     basal inflammatory activation of innate immunity as well as a wasting of specific immunity:~     it is supposed that in the course of life-time due to a multitude of infectious/inflammatory~     events (multiple hits) an inflammatory stress prevails or inflammatory/pathogen burden~     accumulates, which substantially contributes to an enhancement of the inflammatory parameters~     of natural immune response. Such enhanced inflammatory parameters characterize persons at~     increased risk of degenerative diseases like atherosclerosis or coronary heart disease. The~     risk is the higher, the higher the pathogen burden. An impact of the inflammatory load on~     cardiac ageing has not yet been described.~      CARDIAC AGEING, REFLECTED BY A NARROWING OF HEART RATE VARIABILITY: The physiological~     ageing process of the heart goes along with a narrowing of heart rate variability as shown by~     various groups, including our own. Arguments in favour of a causal relationship between~     inflammation and cardiac ageing come from an experimental study with healthy human volunteers~     who had received a low dose of endotoxin: such a proinflammatory stimulus leads to a~     reversible narrowing of heart rate variability (7). Also in senescence heart rate variability~     steadily declines, paralleled by a steady increase of basal inflammatory activity.~      The reduction of heart rate variability also is regarded as a sensitive parameter of~     autonomic dysfunction, which contributes to the compromise of cardiac reserve in old age.~     Apart from typical morphological features and functional deterioration, e.g. diastolic~     dysfunction, the senescent heart is typically characterized by a narrowed heart rate~     variability. Efforts have been made to estimate the cardiac age of an individual by this~     compromised heart rate variability, which may be divergent to the biological age. In recent~     years diverse approaches were proposed to measure cardiac age on the basis of heart rate~     variability. The published mathematical formulae were mostly validated with small patient~     groups and have presently not entered clinical practice. Still heart rate variability is an~     accepted surrogate parameter of cardiac ageing and is amenable by therapeutic measures, e.g.~     beta-blockade.~      The interaction between autonomic nervous system and inflammation is bilateral: thus vagal~     stimulation can improve heart rate variability and at the same time evoke anti-inflammatory~     action: this cholinergic anti-inflammatory reflex could make the basis for pharmacological~     interventions to confine overwhelming inflammatory response syndromes. The afferent vagal~     nerve, on the other hand, can be stimulated by inflammatory mediators and toxins (endotoxin,~     Interleukin-1), thus activating the efferent vagus to release acetylcholine, which can bind~     to a nicotinergic acetylcholine receptor on macrophages and thus interrupt cytokine release~     and limit the rise in the blood levels of proinflammatory cytokines (TNF, IL-6). The~     biological meaning of this reflex is to localise inflammatory reactions in the organism and~     prevent a spill of cytokines to the circulation. A functioning autonomic nervous system is~     thus mandatory to prevent overshooting of inflammatory response to infection and~     non-infectious stimuli. The link between cardiac ageing and autonomic dysfunction gives~     another argument in favour of the notion that autonomic dysfunction and pathogen/inflammatory~     load could be factors promoting cardiac ageing. This, on the other hand, implies the chance~     of slowing down the cardiac ageing process by successfully modulating the extent of autonomic~     dysfunction and the scope of pathogen/inflammatory burden.~      THE NEED FOR A TRIAL:~      A possible causal relationship between basal inflammatory activation and cardiac ageing has~     not been established. This is the issue of the project proposal. In this trial the~     investigators strive to lower the pathogen/ inflammatory load by simple and safe measures.~     The investigators therefore chose treatment with statins, standardised physical training~     (both parameters of heart function and heart rate variability could thus be improved) and~     vaccinations against influenza and pneumococci to prevent a further enhanced pathogen/~     inflammatory burden.~   "
192434|NCT01045499|"~     Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected~     morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or~     older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17~     years lose weight and that the procedure can be performed safely in this age group. We are~     also evaluating the effects of weight loss after LAGB on known comorbid conditions such as~     sleep apnea syndrome and insulin resistance, and also on psychological health.~   "
192435|NCT01045486|"~     There is not enough evidence to support the use of probiotics for prevention or treatment of~     AD in children in clinical practice.~      The purpose of this study is to determine whether probiotics is effective in the treatment of~     atopic dermatitis with cow milk allergy.~   "
192436|NCT01045473|"~     The population of the US is aging. They remain more active and place greater demands on their~     musculoskeletal system. A key problem is that pain and disability of age related spinal~     disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative~     Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are~     treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses~     significant risk for patients in this age group. The use of minimally invasive spinal surgery~     techniques provides an opportunity to treat these patients with less morbidity than~     traditional open surgery.~   "
192595|NCT01043380|"~     The purpose of this study was to evaluate the difference in the effect of coronary plaque~     regression (as measured by intravascular ultrasound [IVUS] imaging) between cholesterol~     absorption inhibitor and cholesterol synthesis inhibitor.~   "
192437|NCT01045460|"~     Patient Population: Patients with active myeloma (Stage II/III) that have completed induction~     therapy and are eligible for an autologous stem cell transplant.~      Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of~     aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the~     activated MILs and is at least 6 months post-transplant.~      Study Objectives:~      Disease response as determined by the Blade' criteria will be the primary endpoint of the~     trial at one year.~      Additional study endpoints include progression free survival, parameters of T cell~     reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and~     clonogenic myeloma precursor cells.~   "
192438|NCT01045447|"~     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).~      The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with~     insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and~     oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the~     trial.~   "
192439|NCT01045434|"~     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,~     crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR capsules of Dr. Reddy's~     Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets)of~     Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fed~     conditions.~   "
192440|NCT01045421|"~     This is an open-label, multicenter study with a phase 1 dose escalation portion and a~     2-stage, phase 2 portion, investigating MLN8237 (alisertib) in patients with advanced~     nonhematological malignancies.~   "
192441|NCT01045408|"~     Helicobacter pylori (HP) is the major risk factors of gastritis, gastric ulcers, duodenal~     ulcers, mucosa associated lymphoid tissue lymphoma and gastric cancer. Helicobacter pylori~     are found in 70-90% of the population in developing countries and in 25-50% of developed~     countries.~   "
192442|NCT01045395|"~     Our overall goal is to evaluate the safety and efficacy of consumption of two algae~     formulations compared to a placebo on: degree of severity of skin lesions, plasma lipid~     levels, as well as other health-related markers, in individuals with clinically diagnosed~     psoriasis.~   "
192443|NCT01045382|"~     The present project aims at evaluating the capacity of MSC to improve one-year overall~     survival of patients transplanted with HLA-mismatched PBSC from related or unrelated donors~     after non-myeloablative conditioning.~      Co-infusion of MSC has been shown to facilitate engraftment of hematopoietic stem cell (HSC)~     in an immunodeficient mouse model. In addition, it has been shown that infusion of third~     party MSC in HSC transplantation could be successfully used as treatment for grade II-IV~     steroid-refractory acute graft versus host disease.~      One hundred and twenty patients with HLA-mismatched donors will be included over 6 years at~     multiple centers across Belgium through the transplant committee of the Belgian Hematological~     Society. The conditioning regimen will consist of fludarabine and 2 Gy TBI, followed by the~     infusion of donor HSC. Patients will be randomized 1/1 in double-blind fashion to receive or~     not MSC (1.5-.3.0 x106/kg) from third-party (either haploidentical family members or~     unrelated volunteer) donors on day 0. Postgrafting immunosuppression will combine tacrolimus~     and MMF. Except for the collection, expansion and infusion of MSC, the clinical management of~     the patient will not differ from that of routine NM-HCT.~   "
192444|NCT01045369|"~     The purpose of this study is to see if using a combination of other drug classes, like the~     ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your~     blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so~     their use in this study is experimental.~   "
192445|NCT01045356|"~     The purpose of this study is to measure blood levels of TXA in children having cardiac~     surgery which requires cardiopulmonary bypass. TXA is used to reduce bleeding during surgery.~     This study will help determine if the current dosing of TXA results in therapeutic blood~     levels.~   "
192446|NCT01045343|"~     The purpose of this clinical trial is to evaluate the potential benefits of a new heart~     failure diagnostic system for heart failure patients with implanted cardiac resynchronization~     therapy devices. This system consists of patient tools, a new heart failure risk score and a~     new clinician website. This study will evaluate this new system as a whole and establish the~     feasibility of implementing it into clinical practice.~   "
192447|NCT01045330|"~     The aim is to replicate, develop, and pilot test a model of care for the prevention and~     management of functional decline of older patients during hospitalization.~   "
192448|NCT01045317|"~     To investigate the pharmacokinetics of PF-04776548 following administration of a micro-dose~     of PF-04776548 via both intravenous and oral routes.~   "
192449|NCT01045304|"~     Primary Objective:~        -  To assess the objective response rate (ORR) of iniparib (SAR240550) administered as a~          60min intravenous (IV) infusion twice weekly or weekly, in combination with~          gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative~          Breast Cancer (mTNBC).~      Secondary Objectives:~        -  To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR),~          partial response (PR) and stable disease (SD) lasting at least 24 weeks;~        -  To assess Progression-free survival (PFS) and the overall survival (OS);~        -  To assess the safety profile of each schedule of iniparib;~        -  To assess the biological activity in tumor tissue (substudy);~        -  To evaluate the pharmacokinetic (PK) profile of iniparib (substudy);~        -  To characterize molecular and biological profile of tumors (substudy);~        -  To assess the effect of iniparib on poly(ADP)-ribose (PAR) level in peripheral blood~          mononuclear cells (PBMC) (substudy).~   "
192450|NCT01045291|"~     The purpose of this research study is to evaluate the safety of a new pacing method (Fusion~     Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a~     period of 4 months, and determine the effects on different measures of heart failure. This~     new pacing method may allow the heart to pump more efficiently. Participation in this study~     will last approximately 8 months.~   "
192480|NCT01044901|"~     In this research study, we are using heart imaging exams and blood testing, in order to gain~     an improved understanding of the pulmonary (lung) hypertension and cardiovascular (heart)~     complications that often occur in sickle cell patients. Information gathered from the healthy~     volunteers that participate in this study will be compared to information from the sickle~     cell patients in this study in order to help further our understanding.~   "
192451|NCT01045278|"~     Hepatitis C is the leading cause of chronic liver disease in industrialized countries, and is~     the most common indication for liver transplantation. In the Western world, the absolute~     majority of cases of Hepatitis C Virus (HCV) infection are related to the use of injectable~     narcotic drugs. Most injecting drug users contract HCV infection within the first years after~     starting injecting drug use. The aim of this study is to study hepatitis C in a cohort of~     patients registered in clinics providing maintenance therapy for opiate dependence in three~     metropolitan areas of Sweden. The cohort is defined as all patients registered in these three~     clinics at the date of study initiation. The study contains four parts:~      Part I: the first part of the study aims to evaluate the prevalence of HCV exposure in the~     cohort and the proportion of anti-HCV positive participants with chronic infection.~      Part II: Patients with chronic HCV infection will be offered further investigation of chronic~     liver disease, including liver biopsy, for selection of candidates for antiviral therapy and~     identification of risk factors for development of severe liver disease.~      Part III: Based on the results of these investigations, patients will be considered for~     antiviral therapy. Indications for such therapy will mainly be clinical and/or histological~     signs of chronic liver disease with fibrosis. All patients will receive weight-based doses of~     pegylated interferon-alfa-2b and ribavirin.~      Part IV: Study of pharmacokinetic interactions between ribavirin and opiate substitution~     molecule (methadone or buprenorphine) in patients receiving antiviral therapy according to~     part III.~   "
192452|NCT01045265|"~     The objective of this study is to determine if concentrations of raltegravir in semen exceed~     the 50% and 95% inhibitory concentrations of HIV during the dose interval.~      The secondary objective is to determine the extend of raltegravir penetration into semen by~     obtaining semen to plasma ratios across the dosing interval, to determine the area under the~     concentration time curve of raltegravir in semen, and to determine the variability in the~     penetration of raltegravir into the seminal compartment over the dosing period.~   "
192453|NCT01045252|"~     The purpose of this study is to evaluate the hemodynamic values of neonates that are healthy~     and those with various congenital heart diseases and sepsis by using echocardiography and~     USCOM.~   "
192454|NCT01045239|"~     The purpose of this study is to determine whether the new micropulse 577 nm yellow laser is a~     better treatment option compared to the conventional 532 nm green laser for diabetic macular~     edema.~   "
192455|NCT01045226|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating~     patients with prostate cancer.~   "
192456|NCT01045213|"~     Integrated eHealth is an innovative, proactive approach to the management of patients with~     chronic cardiopulmonary disease. Our overall goal is to improve the health of patients by~     integrating guideline-based education, remote disease monitoring, coordinator-based disease~     management and healthcare provider-initiated therapy. Patients enrolled in the program~     receive a set of equipment, including a Health Buddy® telemonitor that connects to a normal~     telephone, as well as instruments to measure oxygen levels (pulse oximeter), lung function~     (spirometer) and activity (pedometer). Through the Health Buddy® patients receive~     guideline-based disease education in their own homes. The Health Buddy® also allows patients~     to transmit daily information about their symptoms, oxygen levels, lung function and ability~     to walk to program coordinators located at the University of Colorado Hospital. Our program~     coordinators are highly experienced nurses or respiratory therapists with expertise in the~     management of chronic obstructive pulmonary disease (COPD) and congestive heart failure~     (CHF). Through this remote disease education/monitoring program, patients learn to take a~     more active role in the management of their own disease. However, once the coordinators~     identify early warning signs of a potential problem, patients are contacted and connected to~     their primary healthcare provider for early intervention. By this integrated approach to~     care, patients learn self-management techniques, physician communication is enhanced, and~     early interventions for problems are possible. We propose to target the Integrated eHealth~     Program to areas of Colorado that are highly impacted by COPD.~      Key Objectives: The key objectives are to improve COPD care in the 16 Colorado counties with~     high COPD mortality rates.~      Target Population: We will target patients with severe or very severe COPD.~      Expected Outcomes: We expect that this study will increase the use of evidence-based~     guidelines in the screening, diagnosis and treatment of COPD, resulting in improved~     quality-of-life and a reduction in healthcare utilization.~   "
192457|NCT01045200|"~     Follow-up programmes consume a large amount of resources with less time for the surgeon to~     take on new patients. The aim of this randomised study was to compare patient satisfaction,~     resource utilisation, and medical safety in patients curatively operated for rectal cancer~     that were followed-up by a surgeon or a nurse.~   "
192458|NCT01045187|"~     Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute~     safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for~     intracavitary vaginal cuff treatment according to the physician's current standard of care.~   "
192459|NCT01045174|"~     A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only~     when a patient is inhaling, rather than creating aerosol continuously. It is thought that~     breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs~     more effectively and therefore lead them to recover from asthma attacks faster than~     conventional continuous-output nebulizer devices. This study compares outcomes including~     hospital admission rates, number of nebulized treatments required, and patient/family~     satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output~     nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency~     department.~   "
192460|NCT01045161|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium~     bromide doses compared with placebo in the treatment of moderate to severe, stable chronic~     obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period~     followed by a 12-week double-blind, placebo-controlled treatment period. This will be~     followed by an open-label 40-week treatment period and a 2-week follow up phone call. All~     patients will receive the higher Aclidinium Bromide during the 40-week open label treatment~     period.~   "
192461|NCT01045148|"~     Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and~     efficacy compared with actual prostate HDR treatment, but does it without the catheters and~     hospital admission. As such, it is a more patient friendly treatment method compared with~     actual prostate HDR brachytherapy as currently practiced. Related, as has previously been~     reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should~     have a high efficacy but with lower acute and chronic morbidity compared with other local~     prostate cancer treatment methods such as permanent seed prostate brachytherapy.~   "
192481|NCT01044888|"~     The investigators evaluated clinical impact of reduced heparin responsiveness (HRreduced) on~     the incidence of perioperative myocardial infarction (MI) and restenosis at 6 months after~     off-pump coronary artery bypass graft surgery (OPCAB) and identified its predictors.~   "
192462|NCT01045135|"~     Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to~     urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%),~     sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries~     are not easy to diagnose as they are not visible when looking at surface anatomy during a~     standard gynaecological examination. The investigators are therefore in urgent need of better~     tools to diagnose these injuries. Having a reliable and easily accessible tool enables~     studies of the consequences of such pelvic floor muscle injuries. It also makes it possible~     for us to explore the effect of interventions such as pelvic floor muscle training and~     surgery in patients with and without pelvic floor muscle injuries. The investigators have~     previously presented data to support the reliability and the validity of the three and four~     dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in~     healthy volunteers and have now a tool to study women before and after delivery. At the~     Department of Obstetrics and Gynaecology, Akershus University Hospital there are~     approximately 4500 deliveries annually and 1500 women are giving birth for the first time.~      Challenges: The invitation to participate in the study will be given to all women expecting~     their first child fulfilling inclusion criteria. The biggest challenges in the project will~     be logistical. To be able to inform, recruit and follow women having their first child is a~     challenge in it self.~      Applications: If it is possible to identify a risk group for pelvic floor injuries before~     delivery, it might be ethical to recommend a prophylactic caesarean section to avoid~     disabling incontinence and prolapse later in life.~   "
192463|NCT01045122|"~     Overview of Protocol:~      Between Subject - Repeated Measures design will be used to assess the airway response of two~     groups of subjects under two different sedated conditions. Each group will be comprised of~     six subjects and will be categorized according to their baseline profile for risk for SDB (<~     10 RDI or > 25 RDI). Some subjects will have been prescribed continuous positive airway~     pressure (CPAP) therapy by their treating physician as a result of their overnight sleep~     study. CPAP treatment is effective in splinting the airway open and thus decreasing the~     incident of airway collapse during sleep. Thus, CPAP utilization will also be tracked as an~     independent and continuous variable as regular CPAP use has been found to be associated with~     increased resistance to UAC (upper airway collapse).~      The experimental conditions will evaluate upper airway patency and instability in response to~     two forms of intravenous sedation: propofol and dexmedetomidine.~      Subjects will be continuously monitored during each experimental condition for respiratory~     effort and flow, and for EEG, EMG, and ECG.~      Respiratory instability will first be assessed while subjects are under sedation without any~     airway provocation. The degree of respiratory instability will be quantified in terms of the~     following measurements: a modified Respiratory Disturbance Index (RDIsedated), respiratory~     arousals, and minute ventilation. The apneic periods will be classified by their mixture of~     central and obstructive components.All outcome measurements are assessed over the period of~     sedation which last for approximately one hour.~      Upper airway patency will be quantified in terms of the critical pharyngeal pressure (Pcrit)~     (the pressure beyond which complete upper airway collapse occurs, see background).~   "
192464|NCT01045109|"~     This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum~     prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade,~     low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10;~     clinical stage T1C or T2a), who elect to have their disease monitored through active~     surveillance for at least one year.~   "
192465|NCT01045096|"~     The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole,~     once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.~   "
192466|NCT01045083|"~     This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to~     characterize the response to three centrally active drugs and placebo.~   "
192467|NCT01045070|"~     Atherosclerosis is an inflammatory disease. The hypothesis of an infectious burden as~     trigger or initiator of the inflammatory process in atherosclerosis has been extensively~     discussed in the past years. One part of this discussion is focused on the infectious agents~     responsible for periodontitis. Several studies have found an association of periodontitis~     and/or bacteria related to this disease and atherosclerosis. However, a study focussing on~     the prognostic relevance of these factors is missing.~      The hypothesis of this study is that periodontitis is a prognostic relevant risk factor for~     patients with angiographically proven coronary heart disease. Furthermore, the infectious~     pathogen burden by PCR-detection of periodontal pathogens will be evaluated as a prognostic~     factor.~      960 consecutive patients with angiographically proven coronary heart disease will be included~     in this study. After inclusion of patients an extensive periodontal examination including~     PCR-sampling for 11 bacteria (Porphyromonas gingivitis, Actinobacillus actinomycetemcomitans,~     and others) will be performed. After 12 months patient will be follow up for any major~     adverse events (cardiovascular death, myocardial infarction, stroke).~      If this study will find a relation of periodontitis or its microbiological agents to~     cardiovascular outcome of patients with coronary heart disease, further studies are necessary~     to investigate potential therapeutic consequences for patients with CHD and periodontitis.~   "
192468|NCT01045057|"~     During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice~     prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During~     this study a new surgical tool will be investigated that creates the puncture and places the~     voice prosthesis.~   "
192469|NCT01045044|"~     We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with~     breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use~     MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these~     women. The results will be compared to a control group of normal healthy women. We will try~     to determine if MRI can be used to predict tumor response and cognitive changes related to~     the chemotherapy.~   "
192482|NCT01044875|"~     The purpose of this study is to measure effectiveness of yellow 577 nm laser compared to~     conventional green laser 532 nm for diabetic retinopathy in terms of number of treatment~     sessions required and visual acuity outcome.~      The study also compares pain score of patients receiving laser treatment and side effects of~     laser treatment.~   "
192470|NCT01045031|"~     There is substantial research on the effects of physical exercise on cognitive functions.~     However, less attention has been paid on the requirements of training intensity and length to~     enhance cognitive abilities in the elderly. To the investigators knowledge no studies have~     evaluated the effects of extensive endurance exercise training on cognitive functions by~     studying elderly marathon runners and bicyclists. On the basis of the scientific literature~     published so far it is not known whether the beneficial impact of endurance exercise training~     depends on the intensity of training.~      The investigators therefore designed a cohort study with adequate power in order to evaluate~     the effects of intensive endurance exercise training on cognition. This trial, an Austrian~     prospective cohort study in cognitive function of elderly marathon-runners (APSOEM) is being~     conducted and will compare neuropsychological performance outcomes of elderly marathon~     runners or bicyclists with controls matched concerning age, education years, occupation, and~     verbal intelligence.~   "
192471|NCT01045018|"~     The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were:~        -  To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and~          Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and~        -  To evaluate the safety of MDRT 2.4 g per day (800 mg three times daily) compared to~          placebo.~   "
192472|NCT01045005|"~     The investigators aim to show that quantitative analysis of doppler flow velocity waveforms~     i.e. ultrasound which is a non−invasive and very safe means of assessing blood flow; recorded~     in the proximity of terminal microvascular beds of interest, (i.e. the forearm and ocular~     circulation) can sensitively detect and track local changes in microvascular haemodynamics~     i.e. the function of the small blood vessels that are found in the back of the eye and in the~     forearm.~      The investigators also aim to relate change in the doppler spectral flow velocity waveform~     i.e. the ultrasound signal, in the central retinal artery to changes in geometry and tone of~     the vasculature (or changes in the structure and function of small blood vessels) in response~     to inhaled oxygen and carbon dioxide. The geometry and tone of the vasculature (or Blood~     Vessels) can be measured by taking photographs of the back of the eye.~   "
192473|NCT01044992|"~     Background: Multiple System Atrophy (MSA) is an atypical parkinsonian syndrome including~     cerebellar impairment and poor response to dopatherapy. The objective of the study is to~     assess right-hand motor activation in MSA patients before and after an acute levodopa~     challenge and to compare these data with those obtained in patients with Parkinson Disease~     (PD) and healthy volunteers (HV).~      Methods: Eighteen MSA patients, eight PD patients and 10 age-matched HV will be included.~     rCBF measurements with H215O PET will be performed at rest and during a right hand movement.~     Statistical parametric mapping will be used to analyze motor versus rest in OFF and ON~     condition and effect of levodopa on motor activation.~      Hypothesis: MSA and PD patient should recruited different motor networks.~   "
192474|NCT01044979|"~     The purpose of this study is to evaluate a method of sampling interstitial fluid from~     subcutaneous sewn wicks.~   "
192475|NCT01044966|"~     Current treatments for Glioblastoma Multiforme (GBM), the most common and malignant primary~     brain tumor are inadequate and as such, the median survival for most patients with GBM is on~     the order of months, even after cytoreductive surgery, radiation and chemotherapy. This study~     aims to develop a new treatment for GBM by suppressing glial progenitor cells that surround~     the ventricular system in patients with these aggressive tumors because it is these regions~     that appear to act as an incubator for future recurrences resulting in patient death.~     Considering the lack of significant treatment options for patients with this uniformly fatal~     disease, this is an important translational clinical study to perform.~   "
192476|NCT01044953|"~     The winter break within the German Professional Football Leagues will be shortened as for the~     season 2009/2010 from 6.5 to 3.5 weeks. That might have repercussions on injury incidence in~     either way, positive or negative. On the one hand, recovery time during the winter will be~     shorter, which might lead to an increased risk of injury. On the other hand, it will allow a~     better spread of games in the second round, thus reducing the amount of the so-called~     English weeks, which in turn could reduce the number of injuries. This study compares~     injury incidence between the season 2008/2009 (long winter break) and the season~     2009/2010(short winter break) via questionnaires in accordance with UEFA/FIFA injury~     evaluation criteria.~   "
192477|NCT01044940|"~     The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and~     plasma in healthy children under two years, in asphyxiated babies and in children undergoing~     heart surgery.~   "
192478|NCT01044927|"~     Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death in the United~     States, affects 24 million people and is responsible for up to $32 billion annually in direct~     and indirect health care costs. Based upon these national COPD prevalence data, we estimate~     that 483,000 Coloradans have COPD (193,000 diagnosed and 290,000 undiagnosed), and that the~     care of these patients costs up to $490 million annually. Therefore, to alter the impact of~     COPD on the State and People of Colorado, we propose to introduce a telephone-dependent,~     internet-supported, self-monitoring eHealth management system in both urban and rural~     Colorado settings in order to decrease healthcare utilization, improve the management of COPD~     based upon current national guidelines, improve quality of life, reduce health care costs~     decrease COPD exacerbations. We base this program on a successful clinical pilot study,~     performed at the University of Colorado Hospital (UCH) during 2004-2005, which demonstrated~     dramatic improvements in quality of life and decreased health care costs. We propose to~     enroll patients with advanced COPD, or a history of COPD exacerbations, because these are the~     patients with the highest healthcare costs, the greatest disability, and the highest~     mortality. The ultimate goal of this project is to demonstrate the feasibility and efficacy~     of this proactive management strategy as it is disseminated throughout urban and rural~     Colorado. In this first phase we will target two Denver Metro sites, UCH and~     Kaiser-Permanente (KP), and rural sites (to be determined). We chose these urban sites~     because of their strong interest in enacting the eHealth Program, because of their organized~     systems of healthcare delivery and because of the numbers of COPD patients that they serve.~     We are particularly enthusiastic about the application of this technology to rural,~     underserved areas, because this approach has the potential to dramatically improve delivery~     of healthcare to a large portion of Colorado that is chronically plagued by inadequate health~     care networks and lack of specialty care. More broadly, we are enthusiastic about the~     prospect that eHealth programs may hold the potential to improve healthcare delivery for many~     chronic illnesses, in addition to COPD.~   "
192479|NCT01044914|"~     Pharmacological treatment of schizophrenia is still characterized by a certain proportion of~     patients who are resistant to common antipsychotics. Variability in individual response~     ranges from patients who experience complete or near complete symptom remission to a subset~     of patients who remain treatment-refractory despite extensive drug trials over years. The~     investigators propose to take advantage of the simultaneous acquisition of clinical and of~     intermediate phenotypes to ascertain the possible contribution of SNPs within putative~     causative genes to response to treatment with quetiapine XR.~   "
192483|NCT01044862|"~     The objective of this application is to identify a pharmacologic agent which helps couples in~     whom the female partner ovulates regularly successfully obtain their goal of delivering a~     healthy child, whose use will result in low rates of multiple gestations. The central~     hypothesis is that, in infertile ovulatory women undergoing ovarian stimulation (OS) and~     intrauterine insemination (IUI), the use of aromatase inhibitors (AI) will stimulate the~     ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly~     reducing the numbers of multiple gestational pregnancies that result from stimulation with~     clomiphene citrate (CC) or follicle stimulating hormone (FSH). The rationale for the proposed~     research is that reduction of multiple pregnancy rates could significantly reduce maternal~     and neonatal morbidity and mortality, as well as the cost of healthcare for these individuals~     and society.~   "
192484|NCT01044849|"~     Blood pressure meter model CH-609 was to be assessed against the standard mercury~     sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.~   "
192485|NCT01044836|"~     The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203~     with those of etanercept after subcutaneous injection in healthy male volunteers.~   "
192486|NCT01044823|"~     One of the biggest challenges in caring for patients with Rheumatoid Arthritis (RA) and~     Juvenile Rheumatoid Arthritis (JRA) is quantifying the degree of disease activity in any~     given joint. We have built a prototype device using well-established sensors to rapidly~     quantify surface swelling and heat in arthritic joints. The goal of our studies is to test~     the hypothesis that this Imager can improve the clinical assessment of arthritis.~   "
192487|NCT01044810|"~     The primary objective of this study is to compare the effectiveness of EFV-based regimens in~     HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV~     simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a~     period of time, i.e. staggered interruption; and (3) started EFV-based regimens as an~     initial regimen (as controlled group).~   "
192488|NCT01044797|"~     The purpose of the study is to learn about the feasibility of moving a pill-sized camera~     (Givens Capsule) remotely in the esophagus and stomach using an external hand held magnet.~   "
192489|NCT01044784|"~     The purpose of this study is to evaluate the effects of various LV-LV delays during~     multi-site left ventricular (MSLV) pacing on mechanical dyssynchrony in cardiac~     resynchronization therapy (CRT) patients post-implant.~   "
192490|NCT01044771|"~     The study is designed to evaluate the proportion of patients with tenofovir induced~     proteinuria that will resolve their proteinuria when the tenofovir containing~     nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment~     regimens contain nucleoside/nucleotide combinations that may have long-term side effects~     including nephrotoxicity. Switching these backbones out for an integrase inhibitor based~     regimen has not been systematically evaluated.~      Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when~     tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing~     raltegravir and a boosted protease inhibitor in patients without preexisting protease~     inhibitor mutations is safe and does not lead to virologic failure~   "
192491|NCT01044758|"~     This research is being done to find out if daily use of the drug levetiracetam can improve~     memory function in individuals with memory problems like those associated with Mild Cognitive~     Impairment (MCI) and Alzheimer's disease (AD).~   "
192492|NCT01044745|"~     This phase II trial is studying how well rituximab works in preventing acute~     graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for~     hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell~     transplant helps stop the growth of cancer cells. It may also stop the patient's immune~     system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving a monoclonal antibody, rituximab, together with~     anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the~     transplant may stop this from happening~   "
192493|NCT01044732|"~     The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of~     a standard colonoscope to provide an additional, retrograde (or backward) view that reveals~     areas behind folds and flexures in the colon, and might detect additional polyps that cannot~     be seen with the colonoscope alone.~      Patients who participate as subjects in the study will undergo two complete colonoscopy~     procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used~     along with the same colonoscope. Half of the patients will have the standard colonoscopy~     first followed by the Third Eye colonoscopy, and the other half will have the Third Eye~     procedure first.~      Results from the two groups will be analyzed and compared to determine the effectiveness of~     the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the~     standard colonoscope alone.~   "
192494|NCT01044719|"~     Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the~     study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or~     21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.~   "
192495|NCT01044706|"~     The objective of this study is to compare the rate and extent of absorption of bicalutamide~     50 mg tablet (test) versus Casodex® (reference), administered as 1 x 50 mg tablet under fed~     conditions.~   "
192496|NCT01044693|"~     The purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol~     (Bystolic), compared to metoprolol (Lopressor) and sildenafil (Viagra) on blood pressure in~     patients with autonomic failure and supine hypertension.~   "
192497|NCT01044680|"~     The purpose of this study was to determine the effects of NUTRIOSE® supplementation on body~     composition, satiety, and determinants of metabolic syndrome in overweight men.~   "
192498|NCT01044667|"~     The primary objective of this study is to evaluate gastrointestinal (GI) symptoms and health~     related quality of life in lung transplant recipients converted from Mycophenolate Mofetil~     (MMF) to Myfortic as part of standard immunosuppressive therapy.~   "
192833|NCT01040208|"~     The current trial will explore the safety of flibanserin in combination with Selective~     Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a~     representative population of women with depressive and possible concurrent anxiety~     symptomatology.~   "
192499|NCT01044654|"~     This research study is being carried out to study a new way to possibly treat HIV. This agent~     is called a Zinc Finger Nuclease or ZFN for short. ZFNs are proteins that can delete~     another protein named CCR5. This CCR5 protein is required for certain types of HIV (CCR5~     tropic) to enter into and infect your T-cells. T cells are one of the white blood cells used~     by the body to fight HIV. The most important of these are called CD4 T-cells.~      Some People are born without CCR5 on their T-cells. These people remain healthy and are~     resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and~     their HIV disease is less severe and is slower to cause disease (AIDS).~      Even with no detectable levels of HIV in the blood, HIV remains in some tissues in the body,~     primarily the gut tissue. HIV infects the CD4+ T-cells including in the blood and gut. The~     new treatment to be studied will involve removing white blood cell from the blood that~     contains CD4+ T-cells. The extracted CD4+ T-cells are then genetically modified by the ZFNs~     to be resistant to infection by HIV by removing the CCR5 gene from the surface of the CD4+ T~     cell where HIV enters the cell. Additional genetically modified cells are manufactured and~     then re-infused back into you. Researchers hope that these genetically modified cells will be~     resistant to infection by HIV and will be able to reproduce additional resistant CD4+ T-cells~     in your body.~      Laboratory studies have shown that when CD4+ T-cells are modified with ZFNs, HIV is prevented~     from killing the CD4+ T-cells. On the basis of these laboratory results, thre is the~     potential that ZFNs may work in humans infected with HIV and improve their immune system by~     allowing their CD4+ T-cells to survive longer.~      The purpose of this research study is to find out whether zinc finger modified CD4+ T-cells~     are safe to give to humans and find how zinc finger modified T-cell affects HIV.~   "
192500|NCT01044641|"~     The purpose of this study is to identify normal values of colloid osmotic pressure in~     interstitial fluid and plasma in healthy children between 2 and 10 years.~   "
192501|NCT01044628|"~     This multicenter randomized placebo controlled trial aims to determine if in patients with~     COPD not qualifying for LTOT but presenting significant nocturnal arterial oxygen~     desaturation, whether nocturnal oxygen therapy provided for a period of 4 years decreases~     mortality or delay the prescription of LTOT.~   "
192502|NCT01044615|"~     We will utilize a set of imaging modalities including computed tomography (CT), positron~     emission tomography (PET), and a suite of magnetic resonance imaging (MRI) tools, to~     investigate the changes in the human brain resulting from mild traumatic brain injury (mTBI).~   "
192503|NCT01044602|"~     Best medical management and gastric bypass surgery is a way to treat diabetes as part of~     regular medical care (standard of care). However, gastric bypass surgery is not a way to~     treat diabetes as part of regular medical care (standard of care).~   "
192504|NCT01044589|"~     The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to~     reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in~     controlling episodes of incontinence in patients who have fecal incontinence and a defect in~     the anal sphincter.~   "
192505|NCT01044576|"~     The primary goal of the research cohort is to facilitate patient access to clinical trials~     testing new therapeutic interventions, or access to second- line treatments.~      Secondary objectives of the research cohort study are to obtain detailed clinical phenotyping~     and immunological analysis of blood samples, aiming to identify and validate biomarkers of~     disease activity and response to treatment and prognostic markers.~   "
192506|NCT01044563|"~     The specific aims of this study are:~        1. To develop a breathing training protocol specifically designed to improve HRV and~          psychosocial functioning for postmenopausal women with depressive symptoms,~        2. To examine the immediate effects of an 8-week breathing training program on HRV and~          psychosocial end points in postmenopausal women with depressive symptoms,~        3. To examine the intermediate-term effects of an 8-week breathing training program on HRV~          and psychosocial end points in postmenopausal women with depressive symptoms, and~        4. To determine whether the change in depressive symptoms with breathing training in~          postmenopausal women is associated with the change in HRV.~   "
192507|NCT01044550|"~     Title: A randomized prospective study comparing non operative management with laparoscopic~     treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds.~      Aim of the Study: The aim of this study is to access the clinical outcome of potential occult~     diaphragm injuries in a group of patients presenting at the Groote Schuur trauma centre with~     left sided thoracoabdominal stab wounds, if an expectant non operative management course is~     taken.~      Objects of the Study: To obtain the above mentioned aim the study will undertake;~        -  to do laparoscopy on a group of randomly selected patients with left thoracoabdominal~          stab wounds to obtain the incidence of occult diaphragm injury.~        -  to assess the incidence and clinical outcome of delayed diaphragm visceral herniation in~          the study group.~   "
192508|NCT01044537|"~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with~     Type 2 Diabetes Mellitus (T2DM).~   "
192509|NCT01044524|"~     This study will investigate the absorption, distribution, metabolism and excretion after~     giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be~     determined.~   "
192510|NCT01044511|"~     The aim of this study is to compare, specialist nurse home visits in patients with inoperable~     cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to~     standard patient contact with regards to quality of life, number and character of~     reinterventions and cost-effectiveness.~   "
192511|NCT01044498|"~     This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on~     the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female~     patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child~     bearing age. The RA patients received OC in combination with TCZ, whereas the healthy~     volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8~     mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The~     healthy volunteers received OC for only one 21-day cycle.~   "
192512|NCT01044485|"~     The objective of this phase I/ II study is therefore to assess the safety and efficacy of~     lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in~     first line treatment for metastatic disease should be included in the present study. It is~     proposed to start with a phase I part evaluating the safety of lapatinib 1250 mg with~     docetaxel 75 mg/m² without systematic support of growth factors, starting after the~     completion and data from the 1000 mg lapatinib +75 mg/m² docetaxel dose level in the EORTC~     (Bonnefoi) study.The objective of the phase II part will confirm the safety and evaluate~     efficacy of lapatinib in combination with docetaxel.~   "
192513|NCT01044472|"~     The purpose of this clinical investigation is to evaluate the safety and hemodynamic~     performance of the MSLV Pacing feature in a clinical setting.~   "
192872|NCT01039701|"~     The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs~     Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to~     moderate Alzheimer's disease.~   "
192516|NCT01044433|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving capecitabine together with lapatinib ditosylate may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving capecitabine and lapatinib~     ditosylate together works in treating patients with squamous cell cancer of the head and~     neck.~   "
192517|NCT01044420|"~     There are few studies about 2nd line treatment in advanced esophageal carcinoma(AEC), some~     showed that irinotecan may be effective. The investigators previous study has shown the~     efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study,~     the investigators would like to observe the efficacy and safety of Irinotecan/5FU/leucovorin~     as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.~   "
192518|NCT01044407|"~     To evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise~     ventilation.~   "
192519|NCT01044394|"~     We seek to evaluate whether a same day, reduced liquid volume (2liters) polyethylene glycol~     (PEG-ELS) bowel preparation can achieve adequate colon cleansing in patients scheduled for~     afternoon colonoscopies. The primary outcome will be adequacy of the bowel preparation.~     Secondary outcomes will include Boston Bowel Preparation Scale score, patient compliance with~     completing the preparation, tolerability of the preparation, willingness to repeat the~     preparation, side effects, duration of procedure (endoscope insertion and withdrawal times),~     and polyp detection.~   "
192520|NCT01044381|"~     To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole~     after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting~     in adults with distal subungual onychomycosis of the toenails.~   "
192521|NCT01044368|"~     This project will test the effectiveness of an Internet based glucose monitoring system on~     the A1C levels of patients with type 2 diabetes. All of the patients are given a meter and~     test strips to test their blood glucose levels, however, half of them will be required to~     also upload their meter onto the Internet which can then be viewed by their endocrinologist.~     The doctor can then send a message back to the patient and comment on the readings. The~     effect of the ongoing communication will be measured by the changes in the glucose levels~     (HbA1C) over 3 and 6 months.~   "
192522|NCT01044355|"~     The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison~     to APAP in reducing arterial blood pressure in patients with resistant hypertension and~     obstructive sleep apnea (OSA).~      The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus~     APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory~     markers and glucose regulation; b) to identify specific characteristic of persons who respond~     to the two CPAP modalities in order to identify which device is better for each subject.~   "
192523|NCT01044342|"~     The purpose of this study is to determine if cognitive impairment induced by scopolamine is~     reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by~     electroencephalogram (EEG) measures.~   "
192524|NCT01044329|"~     This randomized clinical trial is conducted to evaluate the effect of three intravitreal~     injections of bevasizumab versus two intravitreal injections of triamcinolone in acute~     retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The~     follow-up time is 6 months.~   "
192525|NCT01044316|"~     This study will evaluate the safety and efficacy of two doses of two commercially available~     vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of~     age.~   "
192526|NCT01044303|"~     The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in~     maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.~   "
192527|NCT01044290|"~     The purpose of this study is to determine whether discussions of life story, forgiveness, and~     future goals improve quality of life for patients with serious illness.~   "
192528|NCT01044277|"~     This trial is designed to provide evidence of the efficacy of glutathione supplementation and~     health(GSH) and includes the assessment of both short term and long term effects. Based on~     previous laboratory animal studies and clinical data, the investigators anticipate that the~     effects of oral GSH supplementation will be progressive and cumulative. The study will also~     allow for the evaluation of effects of withdrawal of the supplement on the outcome variables.~   "
192529|NCT01044264|"~     A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study~     conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical~     Gel formulations.~   "
192530|NCT01044251|"~     This study will analyze the effectiveness of a medication called Frovatriptan, in the context~     of medication overuse headache (MOH). MOH is a headache that develops when pain-killers are~     taken frequently. The treatment is to stop the overuse of these pain-killers, but that can~     sometimes worsen the headache first before it gets better. We are testing Frovatriptan~     against placebo to see if it can help patients with this transition and avoid the worsening~     of the headache that can occur. We will also see if Frovatriptan can help in other ways, such~     as maintain patients free of medication overuse.~   "
192531|NCT01044238|"~     This 4-year study will investigate the effectiveness of methylphenidate for initiating and~     sustaining abstinence in methamphetamine dependent individuals. Approximately 90 participants~     seeking treatment for methamphetamine dependence will be enrolled in the study for an initial~     2 weeks to establish clinic compliance. During this compliance phase, participants will~     receive incentives for clinic attendance. After meeting clinic attendance requirements,~     participants will be randomized to placebo (n = 45) or active study medication (n = 45)~     conditions, and given 18mg/daily of study drug or placebo for one week, followed by~     36mg/daily study drug/placebo for a second week. Finally, participants will be stabilized on~     54mg/daily study drug/placebo for the remainder of the study. Placebo participants will be~     given placebo medications prepared to appear identical to the active medication. In addition,~     after randomization, all participants will receive motivational incentives for~     methamphetamine-negative urine tests and begin weekly cognitive behavioral therapy (CBT)~     provided for the duration of the study.~   "
198800|NCT00960713|"~     The primary purpose of the study is to describe by a prospective observational study the~     serious adverse events occurring in patients treated off-label by rituximab for various~     auto-immune diseases.~   "
192532|NCT01044225|"~     The investigators propose to conduct a multicenter, open-label, randomized, phase II study in~     patients with newly diagnosed glioblastoma (CeCil). Patients should meet all eligibility~     criteria for the CENTRIC phase III trial at the exception that no MGMT-promoter methylation~     could be demonstrated. The treatment backbone in both study arms will consist of~     postoperative radiation therapy with concomitant daily temozolomide, followed by 6 cycles of~     temozolomide according to a 21 out of 28 days regimen (as in the experimental arm of the RTOG~     0525 / EORTC 26052-22053 phase III study). In study arm (A) Cilengitide (at a dose of 2000 mg~     by iv administration, 2x/week) will be added to this backbone while in the second study arm~     (B), Cetuximab will be added (at an initial dose of 400 mg/m² administered by intravenous~     infusion over 2 hours and followed by a weekly dose of 250 mg/m² iv over 1 hours). In both~     study arms, treatment will be administered for 52 consecutive treatment weeks. The 1-year~     overall survival (1y-OS) following randomization will serve as the primary endpoint in both~     study arms.~   "
192533|NCT01044212|"~     The purpose of this study is to assess the effect of a standardized postoperative bowel~     regimen of over-the-counter medications in subjects undergoing minimally invasive~     urogynecologic surgery.~   "
192534|NCT01044199|"~     The purpose of this study is to determine immunogenicity and safety of intradermal~     administration of the PCEC rabies vaccine in adults.~   "
192535|NCT01044186|"~     The purpose of this open-label, non-comparative, multi-center protocol was to further~     evaluate safety and to provide treatment with ICL670 to patients who had or were at risk of~     life threatening complications due to transfusional iron overload with a documented inability~     to tolerate any of the commercially available iron chelators due to severe toxicity rendering~     continued therapy either impossible or hazardous. Patients who were also ineligible for all~     on-going registration trials with ICL670 were included in the study. In exceptional cases,~     patients with a degree of iron overload which was not immediately life-threatening and who~     were ineligible for the registration trials were also enrolled provided they had a~     well-documented, sound justification for alternative chelation therapy.~   "
192536|NCT01044173|"~     At present, CT is the gold standard in the assessment of patients with acute abdomen. Yet,~     one CT of the abdomen exposes patients to a radiation dose equivalent to several years of~     background radiation. MR can be expected to yield the same information without ionizing~     radiation, but tends to be more time consuming. In this study, patients with nontraumatic~     acute abdominal pain referred to CT of the abdomen by the department of surgery will also~     have performed an additional MR scan covering the entire abdomen with few fast imaging~     sequences in approximately 15min. CT is the diagnostic test. The MR scan is only used for~     scientific purposes. It will be evaluated by a radiologist blinded for the results of the CT~     scan. Fourteen days after admission, a final diagnosis is established based on clinical,~     peroperative, pathological and lab. findings. The performance of CT and MR will then be~     compared. The investigators hypothesize that MR can provide a diagnostic accuracy comparable~     to CT.~   "
192537|NCT01044160|"~     This proposal examines trauma and growth responses in the childhood cancer experience. It~     addresses a number of gaps and unanswered questions in the literature, while integrating~     several distinct but related lines of research. The rationale for this proposal is outlined~     briefly as follows:~        1. Traumatic stress models focused on pathology dominate pediatric psychosocial oncology~          research despite empiric evidence of low levels of post-traumatic stress in this~          population.~        2. The assumption of 'cancer as a traumatic event' has biased research designs (including~          lack of control comparisons) to focus on deficits and pathological outcomes.~        3. This deficit-oriented approach has stimulated the development of interventions to treat~          or prevent PTSD, which may be unnecessary or even harmful.~        4. Theoretical and empiric evidence suggests that a more common response to traumatic~          stress is growth and positive change, but posttraumatic growth phenomenon have been~          understudied in pediatric populations.~        5. Cognitive and personality factors are important determinants of PTSD and positive growth~          outcomes, and some constructs from positive psychology theory may be particularly~          relevant in children with cancer.~        6. Empirically, parents of children with cancer appear to be at higher risk of PTSD/PTSS,~          although results are not unequivocal, and the same research biases have applied to~          parental outcomes. This proposal includes assessment of parental PTSS and PTG, both as~          an outcome and a predictor of child outcomes.~   "
192538|NCT01044147|"~     With over half of the US population currently overweight and 31% of adults now obese, the~     primary care setting may represent an important source of weight-loss support, in the~     interest of cardiovascular prevention. Yet, although the US Preventive Services task force~     recommends that physicians screen all adult patients for obesity and offer intensive~     counseling and behavioral interventions to promote sustained weight loss for obese adults,~     the recommendation has not been widely implemented. The Internet may help overcome many of~     the barriers that have prevented intensive obesity counseling in the clinical setting. The~     aim of this study is to examine whether Internet-based interventions for developing healthier~     lifestyles can improve preventive health care in a cost-effective manner.~   "
192539|NCT01044134|"~     Advice to increase water consumption as part of a weight-reducing diet - typically to 8 cups~     (64 fl oz, ~2 L) per day (8x8 water recommendation) - is almost ubiquitously recommended by~     healthcare professionals. Many believe that water promotes weight loss through numerous~     physiological mechanisms. However, only limited observational data and virtually no~     experimental data exist regarding the effects of water consumption on body weight. In this~     study, we propose a randomized controlled pilot study in which two groups of overweight~     adolescents will receive a standard weight loss regimen, either with (experimental~     intervention) or without (control intervention) additional advice and support to increase~     water consumption. We will utilize individual sessions, an innovative text messaging~     protocol, and motivational telephone calls to promote adherence to the interventions. The~     purpose of this pilot study is to evaluate feasibility and obtain preliminary efficacy data,~     to inform design of a future, definitive study.~      It is hypothesized that increasing water consumption will improve the efficacy of a standard~     weight-reducing diet and will lead to decreased consumption of energy-containing beverages,~     decreased total energy intake, improved diet quality, improved immune status, and improved~     cardiovascular and diabetes risk factors. This simple behavioral intervention will be~     feasible and will significantly increase water consumption among participants in the~     experimental vs. control group.~   "
192540|NCT01044121|"~     The primary study objective is to determine whether mattress firmness affects pain in~     patients with chronic low-back pain. We hypothesize that mattresses that differ in their~     firmness and support should have a varying effect on low-back pain patients' level of pain~     and pain-related disability. We also seek to test the hypothesis that the optimal mattress~     might vary from person to person.~      In this regard, we will test:~        1. Whether there is a single mattress that is superior to the others in terms of reducing~          low-back pain and pain related disability.~        2. Whether the optimal mattress for reducing pain varies in the observed population.~   "
192541|NCT01044108|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the~     trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but~     otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up~     period of up to 5 years.~   "
192542|NCT01044095|"~     This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine~     regimens in healthy volunteers using two commercially available seasonal influenza vaccines~     to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be~     spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral,~     cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine~     dose and compared with baseline values.~   "
192543|NCT01044082|"~     The primary purpose of the trial is to evaluate whether the management of placental delivery~     with controlled cord traction (CCT) reduces the incidence of postpartum haemorrhage, compared~     with management waiting for clinical signs of spontaneous placental separation, in women with~     vaginal delivery receiving prophylactic oxytocin for the management of the third stage of~     labour.~      The hypothesis is that CCT, by reducing the length of the third stage of labour, facilitates~     early postpartum uterine contraction and local haemostasis and decreases post partum blood~     loss.~   "
192544|NCT01044069|"~     This study is an investigational approach that uses immune cells, called T cells, to kill~     leukemia. These T cells are removed from blood, modified in a laboratory, and then put back~     in the body. T cells fight infections and can also kill cancer cells in some cases. However,~     right now T cells are unable to kill the cancer cells. For this reason we will put one gene~     into the T cells that allows them to recognize and kill the leukemia cells. This gene will be~     put in the T cells by a weakened virus. The gene will produce proteins in the T cells that~     help the T cells recognize the leukemia cells and possibly kill them. The doctors have found~     that T cells modified in this way can cure an ALL-like cancer in mice.~      The main goals of this study is to determine the safety and appropriate dose of these~     modified T cells in patients with ALL. This will be done in a clinical trial. The dose of~     modified T-cells will depend on if you have disease present in your bone marrow or not. The~     patient will also receive chemotherapy before the T cells. We will use normally chemotherapy~     that is used in patients with leukemia. The chemotherapy is given to reduce leukemia and to~     allow the T cells to live longer.~   "
192545|NCT01044056|"~     An open-label, randomized, parallel group trial in healthy female subjects to compare the~     pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and~     an oral contraceptive (Microgynon® 30).~   "
192546|NCT01044043|"~     This is a 3 months single centre clinical patient-oriented study to evaluate the prevalence~     and impairment in QOL of dermatologic diseases in patients hospitalised in internal medicine.~      Up to 200 patients hospitalised at the division of internal medicine for any reason are going~     to be offered participation by a patient information form given to patients at the time of~     admission, as well as oral information about the study. Written informed consent will be~     obtained by the investigators after patients have had adequate time to consider their~     participation in the study.~      Participating patients will be examined clinically for dermatologic pathologies at a single~     visit. In the case of signs of dermatologic disease, investigators are going to recommend~     further diagnostic procedures to the physician in charge and/or the referring physician,~     depending on the urgency of the suspected diagnosis. This procedure is meant to avoid giving~     referring physicians the impression that active patient acquisition for the department of~     Dermatology is an aim of this study. Diagnostic procedures that are performed upon suspicion~     of a specific dermatologic disease at the Division of Internal Medicine are going to be~     performed during the hospitalisation period. All other diagnostic or operative procedures are~     going to be advised to the referring physician.~      Study participants are going to be interviewed by the investigators about impairment in QOL~     of their illnesses. Two separate questionnaires are going to be filled in by each~     participant. For measurement of general QOL, the widely used SF-12 questionnaire (8~     questions) is going to be used. To measure specific impairment in QOL by dermatologic~     disease, participants are going to be asked to fill in the DLQI (Dermatology life quality~     index, 10 questions). Photographic documentation of specific identified lesions will be made~     and pictures stored exclusively in the secured electronic patient file (KISIM). Medication~     and all identified diseases will be noted. All diagnostically useful information is going to~     be recorded in the patient file and transmitted to the referring physician in the discharge~     letter.~   "
192547|NCT01044030|"~     The primary objective of the proposed study is to determine the effectiveness and safety of~     orally administered viscous-adherent xylitol syrup given in a dose of five grams three times~     daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear~     infection) in children with a history of recurrent acute otitis media.~   "
192548|NCT01044017|"~     This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose~     concentration and other glycemic parameters of efficacy, and the safety and tolerability and~     pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2.~     On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of~     RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is~     <50.~   "
192549|NCT01044004|"~     To determine whether armodafinil is more effective than placebo in reducing fatigue.~   "
192550|NCT01043991|"~     Primary endpoint: Is intracoronary injection of a single dose of darbepoetin alpha, during~     reperfusion in patients hospitalized for ST segment elevation myocardial infarction (STEMI),~     able to reduce infarct size ?~      In in vivo studies, many experiments evidenced infarct size reduction, due to anti-apoptotic~     compounds, when given during reperfusion, after cardiac ischemia. In humans,~     post-conditioning offers such a protection, as the investigators have previously showed~     (Staat P et al. Post-conditioning the human heart. Circulation. 2005 112(14):2143-8).~      Infarct size reduction could lead to a reduced rate of complications (heart failure, rhythmic~     complications) and finally, morbidity and even mortality. This protection depends on~     anti-apoptotic properties (Zhao ZQ et al. Inhibition of myocardial injury by ischemic~     postconditioning during reperfusion: comparison with ischemic preconditioning. Am J~     Physiology Heart Circ Physiology 2003 Aug; 285(2):H579-88). Many drugs have been proposed to~     be able to mimic this phenomenon. Among them, many are efficient but toxic in vivo or~     difficult to manage (insulin, morphin). One of the most promising agent could then be~     erythropoietin (EPO) (Opie LH et al. Postconditioning for protection of the infarcting heart.~     Lancet. 2006; 367(9509):456-8). In order to target ischemia-reperfusion injuries, EPO impact~     is better and better demonstrated (e.g.: Mudalagiri NR. Erythropoietin protects the human~     myocardium against hypoxia and reoxygenation injury via phosphatidylinositol-3 kinase and~     ERK1-2 activation. Br J Pharmacol. 2007 Oct 22). The purpose of the study is to test this~     hypothesis in humans, on the onset of the reperfusion, after myocardial ischemia (acute~     myocardial infarct). EPO could contribute to protect myocardium against ischemia-reperfusion~     injury. This impact could rely on anti-apoptotic properties.~   "
192551|NCT01043978|"~     The overall goal of this project is to identify strategies to prevent overfeeding during~     infancy. One objective is to evaluate the impact on intake of allowing the infant greater~     control over the amount consumed when feeding from a bottle. This will be accomplished via~     the use of a novel nipple that mimics (functionally) the nipple of a human breast and allows~     the infant to self-regulate milk flow. The second objective is to evaluate the relationship~     between parental feeding styles and infant intake.~   "
192552|NCT01043965|"~     The investigators aimed to evaluate microvascular circulation with novel method: real-time~     myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary~     arteries.~      Myocardial blood flow reserve will be determined by quantitative contrast Stress~     echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1)~     and after optimization of medical treatment four months later (Phase 2).~   "
192553|NCT01043952|"~     The objective of the study is to determine wether the use of the Bispectral Index Monitor~     (BIS) as a method to guide anaesthesia for children in different groups of age, undergoing~     ear nose and throat surgery anaesthetized with an infusion of Propofol and Remifentanil with~     an high dose of Remifentanil (0,5-2 mcg/kg/min), can lead to a reduction in the time needed~     for extubation and in the amount of anesthetics used.~   "
192554|NCT01043939|"~     Rationale: Survivors of childhood cancer are at an increased risk of developing~     cardiovascular risk factors as well as early cardiovascular disease, likely due to the~     intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich~     source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and~     healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant~     capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation.~      Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce~     oxidative stress and improve the vascular health of survivors of childhood cancer in the~     early stages of cardiovascular disease.~   "
192555|NCT01043926|"~     This study will determine whether the plasma concentration-time profile and pharmacokinetics~     (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are~     similar to those observed in healthy participants.~   "
192556|NCT01043913|"~     The investigators hypothesize that Guaraná, a native plant from the Amazon, might improve~     chemotherapy-induced fatigue in breast cancer patients undergoing treatment. In order to~     assess this, the investigators randomized patients to either guaraná extract or to placebo,~     switching the assigned treatment mid-term through the cycles of Chemotherapy.~   "
192557|NCT01043900|"~     OCD is a chronic condition with a high rate of poor responders to conventional treatments,~     such as antidepressants and psychotherapy. Chronic symptoms can lead to important social~     impairment and suffering for patients and families.~      The present study aims to investigate if the addition of transcranial magnetic stimulation~     can provide enhanced response to conventional treatment.~      Transcranial magnetic stimulation is a noninvasive technique that can influence specific~     areas of the brain and has very few side effects.~   "
192558|NCT01043887|"~     This study will evaluate the pharmacokinetics of ridaforolimus including the area under the~     concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after~     administration of a single dose of ridaforolimus in patients with moderate hepatic~     insufficiency and healthy matched control subjects.~   "
192559|NCT01043874|"~     To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on~     study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in~     chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or~     later.~   "
192560|NCT01043848|"~     Background: Although a small group, special attention has to be given to lower urinary tract~     (LUT) dysfunctions in spinal cord injury (SCI) patients, as they also suffer under a loss of~     motor-sensory function and autonomic regulation next to the severe deficiencies in bladder~     and bowel control. Autonomic dysregulation linked with LUT dysfunction can cause autonomic~     dysreflexia with life threatening increases in blood pressure and there is still no concept~     for an early rehabilitation of bladder function after SCI.~      Hypothesis: We assume that inadequate reorganization of nerve fibres in SCI is a reason for~     spastic bladder dysfunction and vegetative dysregulation and that this can be positively~     influenced by early neuromodulation. We hypothesized that bladder dysfunction as well as~     autonomic dysreflexia will be positively affected.~      Specific aims: Evaluation, if external pudendal nerve stimulation (EPS) can positively~     influence LUT rehabilitation in SCI patients and if early initiation of stimulation is more~     effective compared to late initiation (after spinal shock).~      Experimental design: Prospective multicentre study in 36 SCI patients (24 treatment subjects,~     12 control subjects). EPS will be started either within 10 days after SCI (early stim group)~     or after cessation of spinal shock (late stim group). Effects on spastic bladder function and~     autonomic disinhibition will be assessed by urodynamics, vegetative tests, and by~     electrophysiological techniques.~      Expected value: If early EPS is effective and complete SCI patients benefit from this~     intervention; and if early onset of EPS has better and longer lasting effects than late onset~     stimulation, the findings will be of utmost relevance not only for bladder function but also~     to alleviate adverse phenomena such as autonomic dysreflexia. Neurostimulation may bear the~     opportunity to early reshape maladaptive neuroplasticity. This would be proof of an effective~     modulation and promotion of neuroplasticity, thus opening up new treatment options in the~     field of paraplegiology.~   "
192561|NCT01043835|"~     The purpose of this study is to compare the short- and long-term results between the~     laparoscopy-assisted gastrectomy and the open gastrectomy.~   "
192562|NCT01043822|"~     The purpose of this study is to describe facial, behavioral and physiologic (heart rate)~     reactivity of children with autism aged 3 to 6 years old, during a painful stimulation~     (venepuncture). Children will be videotaped before, during and after a venepuncture. Each~     recording will be rated with the FACS (Facial Action Coding System) and the NCCPC (Non~     Communicating Children's Pain Checklist).~   "
192563|NCT01043809|"~     The purpose of this study is to assess whether simple, school-based handwashing promotion~     impacts health and hygiene knowledge among students and their families.~   "
192564|NCT01043796|"~     The purpose of this study is to determine whether insecticide treated wall liners, in~     combination with insecticide treated nets, reduce the incidence of malaria infections~     compared to insecticide treated nets alone.~   "
192565|NCT01043783|"~     The investigators ultimate goal is to test the hypothesis that immediate feedback of dietary~     adherence will enhance compliance to a weight loss program. This study deals directly with~     gathering the needed preliminary data for a grant submission.~   "
192566|NCT01043770|"~     The aim of our study is to see if people with metabolic syndrome who attend a group education~     programme based on lifestyle changes (dietary and increased physical activity) can lessen~     their risk of having diabetes, heart disease and strokes in the future.~   "
192567|NCT01043757|"~     Participants will be employees of Genzyme who volunteer to participate in a study on~     motivating healthy behaviors, involving giving them goals for taking a certain number of~     steps per day, and increasing that number over time. Participants will wear pedometers and~     upload their data to a website that allows them to monitor their progress, and have the~     opportunity to win money based on meeting their step goals.~      Interested employees will schedule a day and time to complete a health screening at a Health~     Fair at their place of employment, to ensure that they are healthy enough to participate; at~     this time participants will also complete the investigators baseline dependent measures, and~     receive a pedometer. After a one-week baseline period during which they wear the pedometer~     and the investigators establish their typical number of steps per day, eligible participants~     will then be assigned to one of four treatments - a no incentive control condition, and~     three conditions in which they are entered into different kinds of monetary lotteries if they~     have met their step goals for that day. Participants' initial goal will be based on their~     steps during the baseline period, and the goal will increase by 250 steps each week, for a~     total of 12 weeks. After these 3 months, the incentives portion of the experiment ends, but~     participants continue to wear their pedometers and upload their data for an additional 6~     months. At 3 months, 6 months, and then at the study end at 9 months, participants again~     complete the investigators dependent measures at follow-up Health Fairs at their place of~     employment.~   "
192568|NCT01043744|"~     To evaluate the causes of non-malarial febrile illness in children living in an area of~     perennial malaria transmission and to determine if these children who test negative for~     malaria by rapid diagnostic test receive any benefit from antimalarial therapy.~   "
192569|NCT01043731|"~     Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the~     clinical routine. Few authors have demonstrated the feasibility and safety of such procedures~     (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the~     experience with a transvaginal sigmoidectomy as a first in human report. The aim of this~     prospective data collection is to evaluate the feasibility and safety of the transvaginal~     hybrid anterior resection in the clinical routine.~      Therefore all patients giving the informed consent to the transvaginal hybrid anterior~     resection will be included and assessed concerning feasibility to perform the transvaginal~     approach and complete the operation transvaginally.~   "
192570|NCT01043718|"~     Hershey Medical Center and the University of Pittsburgh are doing a research study to help~     meet the needs of the adult population at risk for diabetes and heart disease. This study~     will provide a web-based program that aims to help participants to develop healthier eating~     habits, lose weight and become more physically active. The Internet-based materials will~     teach participants about healthy eating and physical activity and will ask them to~     incorporate the information they learn into their daily lives.~      The purpose of this study is to evaluate the effectiveness of online lifestyle change~     programs to promote weight loss, healthy eating and physical activity patterns, in the~     interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and~     cardiovascular disease (CVD).~   "
192571|NCT01043705|"~     The purpose of this study is to compare the incidence of cardiac implantable electronic~     device (CIED) infection and CIED mechanical complication after CIED replacement with a~     high-power cardiac implantable electronic device; either a cardiac resynchronization therapy~     device (CRT), or an implantable cardioverter defibrilator (ICD) and TYRX Anti-Bacterial~     Envelope (formerly known as AIGISRx), to the incidence, after replacement with an ICD or~     CRT and no TYRX.~   "
192572|NCT01043692|"~     The aim is to investigate the feasibility and efficacy of an acupuncture intervention on~     persistent MusculoSkeletar pain in a long-term geriatric hospital care ward population. The~     main issue is the acceptability of this type of complementary and alternative medicine in~     older people, although the efficacy on pain is assessed too.~   "
192573|NCT01043679|"~     The goal of this research is to evaluate the safety as well as effectiveness of Utapine and~     Seroquel in bipolar I disorder patients.~   "
192574|NCT01043666|"~     This study is to assess the efficacy and safety of YM178 in patients with symptoms of~     overactive bladder.~   "
192575|NCT01043653|"~     In 2003 the VA Undersecretary's Action Agenda mandated that mental health services throughout~     the system be transformed to a recovery model. That mandate and many of the Workgroup~     recommendations have since been formalized in the Uniform Mental Health Services Package,~     which specifies a range of recovery-oriented services that must be available to veterans. A~     key aspect of these policy mandates is the need to assess recovery status of veterans and to~     monitor their progress over time as a way to evaluate the effectiveness of recovery services.~     However, there is no established instrument that is suitable for system-wide application. The~     purpose of this project is to develop a reliable, valid and practical measure of recovery,~     and use the measure in a study to better understand recovery in individuals with serious~     mental illness.~   "
192576|NCT01043640|"~     Rationale: Chemotherapy administration before a donor stem cell transplant is necessary to~     stop the patient's immune system from rejecting the donor's stem cells. When healthy stem~     cells from a donor are infused into the patient, the donor white blood cells can provide the~     missing enzyme that causes the metabolic disease. Sometimes the transplanted cells from a~     donor can make an immune response against the body's normal cells. Giving a monoclonal~     antibody, alemtuzumab, before transplant and cyclosporine and mycophenolate mofetil before~     and after transplant may stop this from happening. This may be an effective treatment for~     inherited metabolic disorders.~      Purpose: The design of this study is to achieve donor cell engraftment in patients with~     standard-risk inherited metabolic diseases with limited peri-transplant morbidity and~     mortality. This will be achieved through the administration of the chemotherapy regimen~     described. The intention is to follow transplanted patient for years after transplant~     monitoring them for complications of their disease and assisting families with a multifaceted~     interdisciplinary approach.~   "
192577|NCT01043627|"~     Assess tolerability, transition methods and clinical effects of transition from sildenafil~     (Revatio) to tadalafil (Adcirca) for treatment of pulmonary arterial hypertension.~   "
192626|NCT01042964|"~     Primary objective:~      To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time,~     evaluation of antibody titer and safety laboratory tests~      Secondary objectives:~      To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending~     single intravenous doses of PR-15 in healthy volunteers~   "
192578|NCT01043614|"~     Project PEER utilizes a randomized controlled study design to investigate the combined~     effects of an exercise and nutrition intervention that is based on self-efficacy principles~     and delivered primarily by peer educators to reduce the risk for obesity in female college~     freshman over one academic year (N = 300). The control group will receive minimal interaction~     from the research team, paralleling the typical freshman experience on the UIUC campus.~     Recruitment will take place in two waves (consecutive fall terms with n = 150).~      During the final year (Fall 2010) of the project, a General Education course will be offered~     that targets weight management. Importantly, the discussion groups for this course will be~     taught by peer educators trained using the peer resources further refined during the PEER~     project. In addition to conventional measures of content knowledge assessed in the college~     classroom when obtaining class credit, personal physical activity and nutrition behaviors~     along with behavioral determinants (self-efficacy, self-regulatory skills and outcome~     expectations) will also be assessed.~      Primary Aim 1: To determine the effectiveness of a peer-delivered self efficacy-based~     behavioral intervention to enhance nutrition and physical activity behaviors and subsequently~     weight management success in female university freshman over one academic year. We~     hypothesize that freshmen randomized to the intervention group will be more successful in~     losing or maintaining weight than the control group through a combination of diet and~     physical activity strategies.~      Primary Aim 2: To examine the role played by social cognitive factors in changing nutrition~     and physical activity behaviors across one academic year. We hypothesize that self-efficacy~     will have both a direct influence on behavior and an indirect effect through its influence on~     self-regulatory skills and outcome expectations.~   "
192579|NCT01043601|"~     The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol~     fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients~     with moderate to very severe chronic obstructive pulmonary disease (COPD).~   "
192580|NCT01043588|"~     The aim of this study is to compare medical efficacy and cost effectiveness of two surgical~     options for obstructive BPH management : transurethral resection of the prostate with photo~     selective vaporization of the prostate using the high powered 532nm laser.~   "
192581|NCT01043575|"~     The primary objective of this study is to characterize rifapentine drug levels in patients~     with TB in relationship to its effectiveness in treating TB and any adverse effects~     experienced by participants.~   "
192582|NCT01043562|"~     Patients who receive an implantable cardioverter-defibrillator (ICD) usually undergo testing~     at the end of the ICD procedure to measure the amount of energy able to successfully~     defibrillate the heart (defibrillation threshold testing, or DFT). This study proposes to~     perform that measurement in pediatric patients already undergoing clinically necessary ICD~     procedures, with the measurement performed using a binary search method that has been~     previously validated in adult cohorts. We hypothesize that pediatric DFTs, when precisely~     measured, may be lower than previously assumed from extrapolation of adult data.~   "
192583|NCT01043549|"~     Repetitive transcranial stimulation (rTMS) of the posterior parietal cortex will be applied~     daily over five days in adult Gilles de la Tourette patients. This approach aims at reducing~     premonitory sensations believed to induce tics. Patients will be randomized to an active or~     placebo (sham) group in a crossover design.~   "
192584|NCT01043536|"~     The main goal of this study is to evaluate and to determine the dose of a highly accurate~     irradiation (allowing to increase the dose delivered while restricting the risk of~     complication) in association with temozolomide.~   "
192585|NCT01043523|"~     Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging~     agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than~     18 years. Data that has been recorded in the child's medical records relating to the~     injection of Primovist/Eovist will be collected. Information will be collected from up to 2~     weeks before the child received Primovist/Eovist until 12 months after the child received~     Primovist/Eovist. Copy of the child's MR images that were taken right before and after the~     child received Primovist/Eovist and all other reports (laboratory reports, other imaging~     reports, etc) that are part of the child's medical records during that time period will be~     collected.~   "
192586|NCT01043510|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of~     NN1250 (insulin degludec, IDeg) in subjects with type 2 diabetes of different race and/or~     ethnicity.~   "
192587|NCT01043484|"~     The purpose of the study is to evaluate the efficacy and safety of the combination of~     capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly~     with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal~     cancer.~   "
192588|NCT01043471|"~     The purpose of this study is to determine if chewing gum increases energy expenditure and~     decreases food intake.~   "
192589|NCT01043458|"~     A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and~     eliminated by the body of stable schizophrenic volunteers receiving treatment with an~     atypical antipsychotic.~   "
192590|NCT01043445|"~     The purpose of this study is to evaluate the impact of different ligands of GPR 119 (a G~     protein-coupled receptor in the intestine) on the secretion of the incretin hormones, GLP-1~     and GIP.~   "
192591|NCT01043432|"~     Those with traumatic brain injury (TBI) are at increased risk for suicidal behavior, and~     suicidality is associated with executive dysfunction. In the aim of highlighting an important~     risk factor, this study will assess decision making in the context of an interaction between~     suicide and TBI. Findings will also allow for exploratory analyses aimed at identifying~     associations between performance on measures of executive functioning and psychological~     distress. The long-term objective of this study is to increase understanding regarding~     executive dysfunction, as a multidimensional construct, with the ultimate goal of~     conceptualizing assessment tools and interventions aimed at decreasing suicidality in the~     at-risk population of veterans with a history of TBI.~   "
192592|NCT01043419|"~     The purpose of this study is to test the hypothesis that sympathetic neural outflow to~     muscles as well as a sympathetic baroreflexes are not altered during xenon anesthesia in~     Healthy Volunteers.~   "
192593|NCT01043406|"~     The purpose of this prospective, single-arm, unblinded, multicenter clinical study is to~     evaluate the safety and effectiveness of the NeuroVista Seizure Advisory System (SAS) in~     patients with medically refractory epilepsy. A total of 15 subjects will be implanted at up~     to three study sites.~   "
192594|NCT01043393|"~     The objective of this study is to evaluate the potential of desoximetasone 0.25% topical~     spray to suppress HPA axis function. The potential for adrenal suppression will be assessed~     following multiple dosing with Desoximetasone 0.25% Topical Spray in patients with moderate~     to severe plaque psoriasis. The secondary objectives are to evaluate the efficacy parameters~     and to evaluate the adverse event (AE) profile.~   "
192596|NCT01043367|"~     The purpose of the study is to assess the efficacy of DEPREXIL administration in combination~     with relaxation psychotherapy in the treatment of patients with signs and symptoms of~     depression. The duration of this double-blind placebo controlled phase 3 clinical trial will~     be 24 weeks. The estimated number of persons to be recruited and randomized for the study is~     200.~   "
192597|NCT01043354|"~     Background:~      This is a randomized controlled trial (RCT) of two novel behavioral interventions to enhance~     treatment adherence and improve low-density lipoprotein cholesterol (LDL) in diabetes. Among~     adults with diabetes, high LDL greatly increases their risk for cardiovascular disease (CVD).~     Despite the proven efficacy of LDL control(<100 mg/dL) in preventing CVD, the control rate is~     low. Poor adherence to treatment(diet, exercise and medication) is the main reason for this~     poor control.~      Aims: This study will test two telephone-delivered interventions, a Transtheoretical~     stage-matched intervention (SMI) and a Prospect theory-based framing effects intervention~     (FEI). The investigators hypothesize that both SMI and FEI will be more effective in~     improving LDL control than an attention placebo intervention (API) at 6 months. SMI and FEI~     will also be more effective in increasing adherence to medications, diet and exercise than~     API at 6 months.~      Methods:~      The investigators will recruit 246 adults with diabetes and high LDL despite being on~     medications. Key outcomes are adherence to diet, exercise and medication, and LDL control.~     The interventions will be standardized and fidelity of intervention maintained. Using a~     blinded RCT the investigators will test the effect of SMI and FEI compared to API on LDL~     control and adherence. All analyses will be intent to treat.~      Significance:~      This project will provide important information to improve diabetes-related behavior and lead~     to the implementation of novel interventions for lowering LDL in primary care settings among~     adults with diabetes. It may also provide the scientific rationale to use such approaches to~     control other risk factors in diabetes.~   "
192598|NCT01043341|"~     The purpose of this study was to analyze the knowledge and attitude about HPV vaccines among~     Brazilian women after an educative intervention. The knowledge was measured on sexual~     behavior and HPV infection. The attitude was measured on acceptance of vaccines.~   "
192599|NCT01043328|"~     Human papillomavirus (HPV) is one of the most prevalent infections in the world with several~     millions of new cases diagnosed yearly. Oral HPV infection may be associated with different~     diseases of oral cavities including some cases of oropharyngeal cancer.~      The aim of this report is to detect the presence of HPV DNA in samples of biopsies, oral~     swabs, saliva and serum of patient with oral squamous cell carcinoma (OSCC) and controls. We~     hoped to find there is correlation among the presence of HPV DNA in the several biological~     materials and if it is possible to use the saliva as screening to HPV DNA detection. The~     presence of tumor HPV DNA in blood may be of diagnostic and prognostic value.~   "
192600|NCT01043315|"~     The purpose of this study is to identify cardiac patients' degree of unappreciated mild~     impairment in cognitive function patterns of cognitive function, and influencing factors~     related to cognitive functioning during hospitalization. The results from the study will~     contribute to tailoring the delivery of patient education to optimize patient understanding~     of information in future clinical practice.~      It is hypothesized that the study will demonstrate the following:~        1. The degree of cognitive function for patients hospitalized in a CICU will be below the~          scores for normal functioning adults.~        2. Patients with acute cardiovascular conditions will score differently in cognitive~          functioning at various times throughout their hospitalization.~        3. Relationships between cognitive function and following variables:~             -  Patients with greater sleep deprivation or fatigue will exhibit lower cognitive~               functioning.~             -  Patients with greater hunger will exhibit lower cognitive functioning.~             -  Patients who are experiencing greater anxiety will exhibit lower cognitive~               functioning.~             -  Patients who are experiencing depression will exhibit lower cognitive functioning.~             -  Patients who have undergone or will undergo shortly treatment or procedures will~               exhibit lower cognitive functioning.~   "
192601|NCT01043302|"~     The purpose of this study is to determine whether whether surgical resection followed by~     chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and~     quality of life (QOL) in patients with primary intestinal lymphoma.~   "
192602|NCT01043289|"~     The purpose of this study is to determine whether morning bright light therapy is an~     effective treatment for major depression during pregnancy compared with low-intensity placebo~     light therapy, when administered 60 minutes daily for 5 weeks.~   "
192603|NCT01043276|"~     The purpose of this study if to investiagte the time course of PF-00258210 plasma~     concentration in the presence or absence of PF-00610335 administered via oral inhalation~     using dry powder inhalers~   "
192604|NCT01043263|"~     The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in~     subjects with moderate to severe chronic low back pain~   "
192605|NCT01043250|"~     In this study, we are going to investigate quantitative and qualitative natures of appetite~     and eating-behavior changes induced by atypical antipsychotics, i.e., risperidone, olanzapine~     and aripiprazole, in schizophrenia patients.~   "
192606|NCT01043237|"~     The purpose of this study is to determine if coronary artery disease can be detected using an~     electronic, acoustic recording instrument. The presence or absence of abnormal pathology will~     be confirmed by diagnostic angiography as part of the normal patient care at this~     institution.~   "
192607|NCT01043224|"~     The purpose of this trial is to compare the anti-psoriatic effect of a topical combination~     product containing clobetasol propionate and calcipotriol in an ointment formulation to the~     single components in the same vehicle using a psoriasis plaque test design.~   "
192608|NCT01043211|"~     The purpose of this study is to generate further insight into the role and effectiveness of~     the amide local anesthetic lidocaine as an adjuvant postoperative analgesic after adult spine~     surgery. The effect of perioperative intravenous lidocaine infusion on postoperative~     rehabilitation and the inflammatory response will also be examined.~   "
192717|NCT01041768|"~     200 type 2 diabetic patients -BMI between 30-35- will be submitted to bariatric surgery~     (biliopancreatic diversion BPD or gastric bypass GBP ) and 100 will receive standard medical~     treatment.~      Subjects will be monitored during a 5 year period to assess the effects of the surgical~     procedures on diabetes resolution and control at 1, 3 and 5 years.~   "
192609|NCT01043198|"~     Comparative genomic hybridization (CGH) array technology has been used in numerous studies on~     mental retardation, and few chromosomal abnormalities have been identified in patients.~     Because chromosomal abnormalities have still been associated with obesity, we can expect that~     syndromic obesity is also associated with small deletions/duplications. Characterization of~     deleted or duplicated loci in these obese patients would mean that these loci include genes~     implicated in obesity. This will permit to propose new gene(s) involved in obesity. (In~     french: Caractérisation phénotypique et recherche de REManiements chromosomiques chez des~     patients présentant une OBésité syndromique de cause non identifiée : REMOB)~   "
192610|NCT01043185|"~     The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on~     the number of reflux episodes, in patients who have GERD and still experience symptoms~     despite proton pump inhibitor (PPI) treatment.~   "
192611|NCT01043172|"~     The investigators propose to evaluate efficacy and safety of gemcitabine in the adjuvant~     treatment of cholangiocarcinoma after potentially curative treatment with surgical resection.~   "
192612|NCT01043146|"~     Primary Trial objectives:~      To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160,~     240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on~     verum per dose level, 10 subjects receiving placebo)~      Secondary objectives:~      To evaluate safety and tolerability by using adverse events (AEs) and vital signs~   "
192613|NCT01043133|"~     The purpose of the study is to measure the effectiveness of a social marketing-based medical~     education intervention on student use of evidence-based templates for documenting outpatient~     asthma care within an electronic medical record.~   "
192614|NCT01043120|"~     The main purpose of this clinical research trial was to evaluate the effects of barusiban~     compared to placebo on uterine contractions on luteal phase uterine contractions in oocyte~     donors supplemented with progesterone.~   "
192615|NCT01043107|"~     Thyroid Cancer is one of the most common malignant carcinomas. The incidence of thyroid~     cancer has risen in the past years. The recrudesce rate is highly raised. Computer is widely~     used by people nowadays, is it a predisposing factor to the highly raised recrudesce rate?~     This research observed two random assigned groups, in which the patients were diagnosed by~     pathologic results. One group were strictly prohibit with using computer, the other were not~     told. Finally collect the recrudesce rate of each group, analyze the data by statistic~     software.~   "
192616|NCT01043094|"~     This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are~     planned (8 subjects in Group A and 8 subjects in Group B):~      The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the~     ranges for comparison will be obtained from the pooled demographic data of the renally~     impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A,~     the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men~     to women in Group B will be the same as in Group A.~   "
192617|NCT01043081|"~     The purpose of this study is to determine the rates of sexually transmitted infections (STI)~     among a group of African American women who have sex with women (AA WSW). The first study~     hypothesis is that AA WSW are at risk for acquiring and transmitting STI, including the human~     immunodeficiency virus (HIV). The second study hypothesis is that AA WSW participate in~     multiple high-risk sexual activities that may facilitate transmission of STIs, including HIV.~   "
192618|NCT01043068|"~     The purpose of this study was to prospectively evaluate the effect of cancer pain management~     protocol on hospitalized cancer patients.~   "
192619|NCT01043055|"~     This study aimed to validate the diagnostic ability of the CDT (cancer detection technology)~     software to detect breast cancer among women population.~   "
192620|NCT01043042|"~     Both hypoglycemia and hyperglycemia can be detrimental to hospitalized patients. However, it~     is not clear which patients are more likely to develop significant problems with hypoglycemia~     or severe hyperglycemia in the hospital. Our hypothesis is that we will be able to identify~     risk factors present at admission that identify patients at greater risk of poor inpatient~     glycemic control~   "
192621|NCT01043029|"~     This multi-center, randomized, double-blind, active controlled, parallel-group study in type~     2 diabetes patients with moderate renal impairment will evaluate the effect on renal function~     and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be~     randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses.~     In addition, a diet and exercise plan will also be implemented during the anticipated time on~     study treatment of 52 weeks. The target sample size is 200-400 patients.~   "
192622|NCT01043016|"~     The purpose of this study is to determine the safety and maximum tolerated dose of~     Photocyanine injection in photodynamic therapy of malignant tumor (especially skin cancer and~     esophageal cancer).~      Projected accrual: A total of 18-24 patients will be accrued for this study.~   "
192623|NCT01043003|"~     RATIONALE: Studying quality-of-life in patients having cancer treatment may identify the~     intermediate- and long-term effects of treatment on patients with cancer~      PURPOSE: This randomized clinical trial is studying how well an educational intervention~     works in supporting Hispanic women with stage I, stage II, or stage III breast cancer and~     their families or caregivers.~   "
192624|NCT01042990|"~     Testing Adaptive Physical Activity in Stroke tests the idea that adaptive physical activity~     (APA) will improve fitness, balance and walking function, daily step activity, and outcomes~     related to quality of life in individuals with chronic stroke. Adaptive physical activity is~     an exercise model that combines aerobic exercise with balance and gait training in a socially~     reinforcing group setting. Individualized homework assignments encourage integration of~     exercise into daily life routines. Our specific aims are:~        1. to determine whether APA improves cardiovascular fitness and metabolic health~        2. to measure the effects of APA on gait and balance, ambulatory activity, and ADL function~        3. to determine whether APA affects self-reported outcomes related to self-efficacy,~          fatigue, and stroke-specific quality of life~   "
192625|NCT01042977|"~     This study is carried out to assess whether dapagliflozin improves glycemic control,~     decreases fasting plasma glucose levels, body weight and blood pressure when added to~     patient's existing medications and how it compares with their usual treatment without added~     dapagliflozin. Safety data will be collected and analysed to confirm that treatment with~     dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular~     disease~   "
192627|NCT01042951|"~     Background: Severe dehydrating cholera due to V. cholerae O1 is an important public health~     problem in Bangladesh and many other developing countries. V. cholerae O1 is a major~     bacterial pathogen causing around 5 million cases and at least 200,000 deaths in adults and~     children each year. It can be assumed that there are at least 300,000 severe cases and 1.2~     million infections in people in Bangladesh alone. The rate of cholera varies from around 1 to~     8 per 1000 population and the highest attack rate is in children 2- to 9-year years of age .~     Cholera is now also being documented in very young children. Currently enteric vaccine~     approaches are regarded as the most accessible short term and practical means to prevent and~     control such illnesses to prevent disease and epidemics in resource poor settings with~     limited public health and sanitary facilities.~      An effective inactivated whole cell bivalent cholera vaccine against Vibrio cholerae O1 and~     O139 was produced and implemented for public health purposes in Vietnam since the 1990s. This~     bivalent vaccine has been found to be safe and to confer significant protection against El~     Tor cholera in both children and adults and has over the last decade being used in the~     Vietnam to protect against cholera. This vaccine has further been reformulated by the IVI to~     meet WHO requirements and is now being produced in WHO prequalified vaccine company in India.~      The reformulated vaccine has been shown to be safe and immunogenic in Indian children as well~     as adults. A large Phase III study of the vaccine, has recently been carried out in Kolkata,~     India in over 120,000 participants aged from one year and above. Results of the study are~     encouraging and the vaccine gives over 60% protection against cholera. The vibriocidal~     antibody response rate was 80% in children and 53% in adults. Following this study, the~     vaccine, designated as ShanChol has been licensed in India in April 2009. The vaccine is now~     being marketed in India and is available at a cost affordable for developing country~     settings.~      Objective: The aim of the proposed study is to assess if the orally administered, killed,~     bivalent whole-cell cholera vaccine, ShanChol will be safe and immunogenic in different age~     groups in Bangladesh in children and adults.~      Study design: This will be a randomized, double blind, placebo-controlled study on a total of~     330 subjects, 165 vaccine and 165 placebo recipients. The specific aims will be to determine:~     i) safety and determine adverse events if any (ii) determine immune responses.~      Relevance: The study of ShanChol on Bangladeshi children and adults will be able to give~     information regarding the safety and immunogenicity of the vaccine in Bangladeshi subjects.~     This information will be important for proceeding with larger studies in Bangladesh and if~     proven useful for introduction the cholera vaccine in the country in the future.~   "
192628|NCT01042938|"~     Ionizing radiation is a toxic agent and widely accepted form of treatment for various types~     of cancer. Despite advances in medical technology, radiation therapy still causes severe~     early and late skin effects. Radiation-induced dermatitis occurs in approximately 80% of~     patients. Important consequences of radiation-induced dermatitis include impairment of the~     quality of a patient's life due to pain and premature interruption of radiation treatment,~     which in turn, may be impair good local control of disease. The biological pathways~     responsible for acute radiation-induced dermatitis remain unclear. Currently, there is no~     standard treatment for the prevention of radiation-induced dermatitis with demonstrated~     effectiveness. The aim of this randomized, double-blind, placebo-controlled pilot study is to~     assess the effectiveness of curcumin for the prevention of acute radiation-induced dermatitis~     during postoperative radiotherapy for breast cancer. We hypothesize that curcumin, a natural~     phenolic compound found in both turmeric and curry powders, can prevent or alleviate~     radiation-induced skin reactions in breast cancer patients receiving radiotherapy.~   "
192629|NCT01042925|"~     Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in~     combination with trastuzumab (Herceptin) and in combination with trastuzumab and paclitaxel.~     After the MTD is established for each combination (Phase 2), subjects will be enrolled to~     evaluate the preliminary efficacy and safety of these combinations in metastatic HER2~     positive breast cancer. Both trastuzumab and paclitaxel are used in the treatment of~     metastatic breast cancer (MBC), but patients can develop resistance.~      The link between PI3K mutations and trastuzumab resistance has been seen in breast cancer~     patients. This suggests that inhibitors of the PI3K/PTEN pathway may have the potential to~     restore sensitivity to trastuzumab. Similarly, introduction of activated mutant forms of PI3K~     has been shown to transform and confer paclitaxel resistance to immortalized breast~     epithelial cells. XL147 is a potent and selective inhibitor of PI3K and inhibits~     phosphorylation of multiple downstream components of PI3K/PTEN signaling. Therefore, XL147~     may have utility in the treatment of trastuzumab resistant/refractory and HER2-positive MBC~     when administered in combination with trastuzumab alone or with trastuzumab and paclitaxel.~   "
192630|NCT01042912|"~     The purpose of this study is to determine if carotid artery stenosis can be detected using an~     electronic stethoscope. This study will use a commercially available electronic stethoscope~     to record carotid sounds in patients with suspected carotid artery stenosis. The presence of~     absence of abnormal vessels will be confirmed by diagnostic ultrasound as part of normal~     patient care at this institution.~   "
192631|NCT01042899|"~     This study will evaluate the effectiveness of an Internet-based psychosocial treatment in~     improving problem-solving, communication skills, stress management strategies, and coping~     among teens who have had a traumatic brain injury and their families.~   "
192632|NCT01042886|"~     The PILI 'Ohana CBPR partnership implemented a pilot study to determine whether a Family plus~     Community focused intervention will improve weight loss maintenance compared to Standard~     follow-up in overweight/obese Native Hawaiian (NH) and other Pacific People (PP) adults (> 18~     yr. old) after receiving a standard individual-focused behavioral intervention. The primary~     hypothesis was that overweight/obese NH and PP adults that undergo a combined family-focused~     plus community-focused intervention vs. a standard follow-up after receiving a standard~     individual-focused behavioral intervention will have significantly higher rates of weight~     loss maintenance.~   "
192633|NCT01042873|"~     A decrease in the response of beta 1 adrenergic receptors to agonists (desensitization) is~     thought to play a major role in the pathogenesis of diseases such as congestive heart~     failure. However, currently, there is no in vivo model that will enable us to measure~     desensitization of the hemodynamic responses to beta 1 adrenergic receptors in vivo.~      Our hypothesis is that constant 3 hours intravenous infusion of the selective beta1~     adrenergic receptor agonist dobutamine will result in gradual decline in hemodynamic~     responses to dobutamine over time.~   "
192634|NCT01042860|"~     Rationale: Age-related macular degeneration is the most common cause of blindness in the~     industrialized world. Macular pigment is hypothesized to protect against the vision loss in~     this disease.~      Objective: 1. To study if the macular pigment optical density can be raised by lutein~     supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in~     visual functions.~      Study design: Randomized, double blind, placebo controlled intervention study.~      Study population: Eighty patients with early signs of age-related macular degeneration~     Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the~     control group (40 subjects) gets a placebo.~   "
192720|NCT01041729|"~     The purpose of this study is to determine the long-term effects of statins, atorvastatin,~     upon Nitric Oxide, as an endothelial function assessment, and C-Reactive Protein, an~     inflammatory marker, levels in patients with Peripheral Arterial Disease. These long-term~     biological pleiotropic effects of statins will offer information on the role of endothelial~     function and systemic inflammation in the etiopathogenesis of PAD.~   "
192635|NCT01042847|"~     There is growing evidence that our immune system can help fight cancer. This has stimulated~     interest in the development and application of tumor vaccines for several human solid tumors,~     including epithelial ovarian cancer (EOC). A major obstacle to the development of these~     vaccines is that there are specialty cells called regulatory T cells that prevent the immune~     system from attacking all of our organs. These regulatory T cells also prevent our immune~     system for attacking cancer cells.~      Indoleamine 2,3-dioxygenase (IDO), an enzyme that degrades an essential amino acid tryptophan~     that is necessary for T cells to multiply, however regulatory T cells are less susceptible to~     low levels of tryptophan, and can still multiply. This allows cancer growth and progression.~     This may be explained by genetic polymorphisms (changes) in the IDO gene, which may alter its~     function. Five of these changes in the IDO gene have been described. In this research~     project, we are asking if you would donate a small piece of your tumor and ascites to see if~     we can examine your IDO gene in the tumor cells and see if any of these gene changes are~     present. We hope that this will help us understand how the immune system works in EOC.~      We hypothesize that genetic polymorphisms within the IDO gene alter its enzymatic activity~     and affect the outcome of ovarian cancer patients. These findings have the potential to~     translate into a method for predicting successful immunotherapy.~   "
192636|NCT01042834|"~     Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea~     in older subjects.~   "
192637|NCT01042821|"~     This study comprises a prospective study of 40 patients with transphincteric anal fistula.~     The patients were classified into two groups: Group I: Fistulectomy, closure of internal~     sphincter and rectal advancement flap includes mucosa, submucosa, and circular muscle layer~     sutured 1cm below the level of internal opening. Group II: The same as group one but the flap~     includes only mucosa and submucosa.~   "
192638|NCT01042808|"~     This survey is conducted for preparing application materials for re-examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the~     clinical usefulness of Isentress through collecting the safety and efficacy information in~     usual practice according to the Re-examination Regulation for New Drugs.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
192639|NCT01042795|"~     The purpose of this study is to determine whether sutent (sunitinib)is effective in~     preventing tumor recurrence in patients with high risk bladder cancer who have previously had~     chemotherapy and cystectomy (bladder removal).~      A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal.~     The patients are followed up to 2 years.~   "
192640|NCT01042782|"~     Patients with advanced gastric cancer are treated with a combination of RAD001 (everolimus)~     and Mitomycin C.~   "
192641|NCT01042769|"~     This double-blind, parallel, two-arm study will evaluate the potential to reduce~     cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to~     placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and~     type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or~     placebo once daily as oral doses. The study will last until at least 950 events occur, but~     time on study treatment will be for at least 2.5 years.~   "
192642|NCT01042743|"~     The recent introduction of robotic surgical system has revolutionized the field of minimally~     invasive surgery. The investigators hypothesized that adoption of a robotic surgical system~     for patients with right-side colon cancer seems appealing because This system provides~     high-definition three-dimensional vision, eliminates physiologic tremor, and better~     ergonomics. This randomized controlled trial was designed to determine the safety and~     efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.~   "
192643|NCT01042730|"~     The purpose of this study is to evaluate the prevention of cardiovascular disease by moderate~     cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering~     therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.~   "
192644|NCT01042717|"~     The purpose of this study is to determine whether it is safe and effective to collect~     peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after~     administration of plerixafor.~   "
192645|NCT01042704|"~     The purpose of this study is to see if the combination of bendamustine, lenalidomide and~     dexamethasone will help people with multiple myeloma that has returned after standard~     treatment or has been resistant to other treatments.~   "
192646|NCT01042691|"~     The primary goal of this research study is to determine a safe dose for the drug oxaliplatin~     when delivered by isolated hepatic perfusion. The second goal of this research study is to~     determine if isolated hepatic perfusion with oxaliplatin can improve the efficacy of standard~     hepatic arterial infusional (HAI) therapy with floxuridine (FUDR)/leucovorin.~   "
192647|NCT01042678|"~     The purpose of this study is to assess the safety and tolerability of MP0112 (a novel,~     potentially long acting VEGF inhibitor) in patients with diabetic retinal edema.~   "
192648|NCT01042665|"~     The purpose of this investigation is to evaluate the relationship between IOP fluctuation,~     RGC dysfunction, and optic nerve and retinal nerve fiber layer (RNFL) thickness changes in~     patients with glaucoma and ocular hypertension receiving latanoprost 0.005% versus placebo.~   "
192649|NCT01042652|"~     This is a pilot randomized controlled Open-label trial to compare raltegravir and nevirapine~     as anchor Drug in combined antiretroviral therapy(ART) for ART-naive HIV+ Chinese injection~     drug users who are also on methadone maintenance therapy. The investigators hypotheses~     include:~        1. In raltegravir arm compared with nevirapine arm, fewer patients will require methadone~          dose adjustment to abate methadone withdrawal symptoms. Also the average methadone dose~          to achieve adequate serum methadone concentrations in patients on the raltegravir-based~          regimen will be lower compared to that of patients on the nevirapine-based regimen.~        2. Clinical outcomes in terms of viral suppression, CD4 recovery and occurrence of~          opportunistic infections will be comparable in the two arms at 6 months and one year.~        3. Patients in the raltegravir arm will have a similar or better side effect profile,~          retention rate, and treatment adherence compared to those in the nevirapine arm.~   "
198801|NCT00960700|"~     A multi-centre non-randomized clinical investigation to assess multifocal visual outcomes~     using different near additions, for the treatment of aphakia after cataract removal.~   "
192650|NCT01042639|"~     Studies have demonstrated that brief (5-10 min a day) passive range-of-motion exercise is~     beneficial for bone development in very low birth weight (VLBW) preterm infants. However, the~     optimal duration and frequency of exercise for bone development in preterm infants is yet~     unknown.~      The effect of exercise on the immune system was widely studied in adult and children.~     Exercise induces increase in IL-6, IL-10, and IL1ra. In adult even 10 minutes of flexion and~     extension of the wrist cause systemic increase in IL-6. The effect of physical activity on~     pro and anti inflammatory cytokines in preterm infant was not studied.~      Objectives:~        1. To assess weather twice daily exercise intervention will enhance bone strength compared~          to once a day intervention~        2. To evaluate the effect of a single exercise intervention on inflammatory mediators.~      Methods:~      Single center (Meir Medical Center), double blind, randomized control study.~   "
192651|NCT01042626|"~     The purpose of this study is to assess if subjects with hyperparathyroidism with normal serum~     calcium levels have different responses in the calcium regulating hormonal handling compared~     to a) patients with primary hyperparathyroidism and high serum calcium levels; b) healthy~     subjects.~      The differences will be evaluated with oral peptones load and subsequent blood samples~     collected every 15 minutes for two hours. Ionized calcium, phosphate, gastrin and PTH levels~     will be evaluated.~   "
192652|NCT01042613|"~     1. This study will compare the first attempt success rate of cannulation in research~          participants randomized to using a new FDA approved AccuVein AV300 device for~          intravenous access with research participants randomized to standard cannulation~          methods.~        2. This study will assess if insertion of intravenous cannula is faster when intravenous~          access is assisted by the AccuVein AV300 device as compared to the standard technique.~        3. This study will assess if the number of skin punctures is fewer when intravenous access~          is assisted by the AccuVein AV300 device as compared to the standard technique.~   "
192653|NCT01042600|"~     In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via~     nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of~     surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to~     surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and~     return babies to nasal CPAP, after surfactant is given. The primary outcome measure is the~     rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a)~     early, if the baby is unable to be placed back on CPAP (needs mechanical ventilation) or, b)~     late, if the baby requires retreatment with surfactant within 8 hours or more than 2 doses of~     surfactant.~      The objective of this protocol is to reduce the need for endotracheal intubation and~     mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by~     instilling surfactant though an LMA, while achieving comparable efficacy of surfactant~     treatment.~      The hypothesis is that surfactant treatment through an LMA will decrease the proportion of~     babies with RDS who require mechanical ventilation or subsequent intubation, when compared~     with standard surfactant treatment following sedation and endotracheal intubation.~   "
192654|NCT01042587|"~     The investigators hypothesize that significant exposure to artificial morning bright light~     (approximately 200 lux of primarily blue light at eye level for thirty minutes daily) as~     compared to sham bright red light (placebo) will:~        1. improve sleep quality~        2. improve cognitive scores~        3. improve depression scores~        4. improve quality of life scores.~   "
192655|NCT01042574|"~     This study is a single-arm, open label protocol evaluating the use of Cleviprex to rapidly~     control hypertension in patients who present with intracerebral hemorrhage (ICH) or~     subarachnoid hemorrhage (SAH), and that require ICP monitoring via ventriculostomy (External~     Ventricular Drain or EVD).~   "
192656|NCT01042561|"~     We hypothisize that serum 25(OH)D levels in infants 32 weeks and greater gestation are not~     maintained at optimal levels of greater than 32 ng/Ml with currently available infant~     formulas, and that this will have an inverse relationship with markers of inflammation and~     bone metabolism.~   "
192657|NCT01042548|"~     The current study is a case control study involving comparisons of tissue interstitial fluid~     from breast cancer and adjacent non-cancerous tissue as well as that from benign breast~     lesion and its adjacent non-diseased tissue for a distinguishable breast cancer profile. The~     purpose of this research is to collect fresh breast nodule/cancer and surrounding~     non-cancerous tissue for proteomic studies of the interstitial fluid to identify a profile~     distinguishing breast cancer which will also permit future research on stored interstitial~     fluid, blood or tissue samples. Specific markers identified from interstitial fluid study~     will be investigated in blood samples to develop serum markers for breast cancer diagnosis~     and prognosis. Additionally, we will perform both prospective and retrospective research on~     breast cancer involving clinical, demographic, epidemiologic information, treatment,~     follow-up and outcomes on breast nodule/cancer cases collected.~   "
192658|NCT01042535|"~     This randomized phase I/II trial studies the side effects and best dose of vaccine therapy~     and to see how well it works when given together with 1-methyl-D-tryptophan (1-MT) in~     treating patients with metastatic breast cancer. Vaccines made from a person's tumor cells~     and white blood cells may help the body build an effective immune response to kill tumor~     cells.~   "
192659|NCT01042522|"~     This randomized phase II trial studies paclitaxel and carboplatin to see how well they work~     compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with~     sex cord-ovarian stromal tumors that have spread to other places in the body and usually~     cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs~     used in chemotherapy work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known~     which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.~   "
192660|NCT01042509|"~     The purpose of this study is to determine whether low-doses alemtuzumab and rituximab~     combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after~     first-line therapy failure.~   "
192816|NCT01040429|"~     The purpose of this study IS to~        -  explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents,~          particularly focusing on genetics, infections/immunology, endocrinology, autonomic~          control and cognitions~        -  to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity)~          in adolescent CFS.~   "
192661|NCT01042496|"~     This study compared glutamate and other neurometabolites measured by proton magnetic~     resonance spectroscopy (1H-MRS) in bipolar I and II patients currently depressed with~     age-matched healthy controls. The study will also compare 1H-MRS of bipolar I and II patients~     before and after taking a 12-week course of lamotrigine.~      The goal of this study was to better understand the neurobiology of bipolar depression and~     how lamotrigine may therapeutically impact brain function and mood response.~      The hypothesis was that in comparison to non-remission participants, bipolar participants who~     achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score <12~     at week 12) associated with lamotrigine monotherapy will exhibit a greater decrease in~     glutamate (Glu) and an increase in N-acetyl aspartate (NAA), reported as a cerebrospinal~     fluid (CSF)-corrected absolute concentration percent change from baseline to endpoint in~     anterior cingulate (AC) and dorsolateral prefrontal cortex (DLPFC).~   "
192662|NCT01042483|"~     The purpose of this study is to establish normograms of parameters measured by the LaborPro~     system, and to test the prediction of these parameters on labor progress and mode of~     delivery.~   "
192663|NCT01042470|"~     Pelvic floor dysfunction in the form of pelvic organ prolapse or urinary and fecal~     incontinence is a sequela for some women who experience injuries during birth. It affects~     adult women of all ages. The life time risk for women by age of 80 years for undergoing~     surgical correction is shown to be 11.1 % , and 29 % of them will undergo re-operation for~     recurrences later on. Still, even today the biomechanics of the pelvic floor is not~     understood enough. The aim of our study is to investigate the biomechanical properties of the~     female pelvic floor, i.e. the vaginal wall, by means of clinical, sonomorphometric~     (ultrasound), histological and elastomechanical examinations. In principle, the~     elasto-mechanical properties of the vaginal wall will be examined by the new and innovative~     so called aspiration device, developed at the Eidgenoessische Technische Hochschule (ETH)~     Zurich, Switzerland. This tool generates a low-pressure of -25 mbar at the vaginal wall,~     aspirating it under visual control by aid of an integrated video camera and therefore~     allowing to measure the difference of its convexity under aspiration and at rest. In case of~     prolapse surgery, this allows us to take a biopsy of the measured vaginal wall and analyze it~     at the Institute of Anatomy at the University of Zurich-Irchel by means of histological (e.g.~     connective tissue, extracellular matrix) and molecular biological examination. With an~     increasing elderly population, more and more women will need surgery for pelvic organ~     prolapse. While effective in restoring anatomy, sometimes by aid of meshes made out of~     polypropylene, the functional outcomes and quality of life are not always restored~     satisfactorily. This interdisciplinary project intends to add a contribution to this for our~     patient still bothersome situation and to help to detect risk factors for developing pelvic~     floor dysfunction.~   "
192664|NCT01042457|"~     To evaluate therapeutic response to MMF treatment in patients with International Society of~     Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic~     acid levels at 1-hour post dose will be monitored monthly up to 6 months.~   "
192665|NCT01042444|"~     This is a multi center, prospective study designed to demonstrate the safety and performance~     of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous~     vein graft (SVG) interventions.~   "
192666|NCT01042431|"~     This study is a one-day international cross-sectional nutritional audit in one ward. The~     purpose of this study is to generate a risk and level of nutritional intervention profile for~     an individual unit/ward based on case-mix, structures and social environment.~   "
192667|NCT01042418|"~     Food structure influence metabolic response including appetite. Whole grain foods include a~     wide range of products; cracked or cut kernels, rolled flakes or milled to flour and used in~     foods such as breads, breakfast cereals and pasta.~   "
192668|NCT01042405|"~     The aim of the study is to develop a simple computer program, evaluating nutritional status~     of HD patients. The programming will enable to perform a nutritional screening, based on~     biochemical measures, taken as part of HD patients' routine care every month. The program~     will identify patients at risk of malnutrition, define the degree of malnutrition, and~     identify patients who at risk for increased morbidity and mortality.~   "
192669|NCT01042392|"~     This prospective multicenter, double blind study will evaluate the efficacy and safety of~     aliskiren versus ramipril in patients with moderate systolic essential hypertension.~   "
192670|NCT01042379|"~     The purpose of this study is to further advance the ability to practice personalized medicine~     by learning which new drug agents are most effective with which types of breast cancer tumors~     and by learning more about which early indicators of response (tumor analysis prior to~     surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are~     predictors of treatment success.~   "
192671|NCT01042366|"~     The purpose of this study is to determine what effect using an experimental tumor vaccine (a~     substance or group of substances meant to cause the immune system to respond to a tumor) made~     using patients' own tumor cells and blood cells will have on their melanoma.~   "
192672|NCT01042353|"~     -  Background: Ventilator-acquired pneumonia (VAP) is the most prevalent nosocomial~          infection in intensive care units (ICUs). Early microbiological diagnosis and initial~          administration of appropriate antimicrobial therapy are associated with a better~          outcome. Broad-spectrum antibiotics should therefore be administered initially. However,~          inconsiderate antibiotic use can increase the prevalence of multi-resistant bacteria.~        -  Purpose: A rapid antimicrobial susceptibility method is required to decrease the~          unnecessary use of empirical broad-spectrum antibiotics. The aim of this study is to~          compare the efficiency of a rapid antibiogram, provided by E-test strips directly~          applied to bronchoalveolar lavage (BAL) samples and analysed at 24 h, to that obtained~          with standard methods of culture which provide a later result.~        -  Study design: This will be an open-label, prospective cohort study of consecutive~          patients with VAP, conducted in a medical ICU. In addition to standard culture methods,~          an E-test will be performed directly on BAL samples and analysed at 24 h. Each standard~          BAL culture will be used as a control for the E-test method.~        -  Primary outcome: The occurrence of major errors, defined as isolates determined to be~          susceptible by the E-test but resistant by standard culture methods.~        -  Secondary outcomes: The occurrence of minor errors (defined as isolates determined to be~          resistant by the E-test and susceptible by the standard method), and a comparison of two~          methods of seeding BAL samples on Mueller Hinton agar plates (swabbing method, flooding~          method).~        -  Eligibility criteria:~             -  Inclusion criteria: all patients with suspected VAP (defined by a Clinical~               Pulmonary Infection Score ≥5) undergoing BAL will be eligible.~             -  Exclusion criteria: contraindications for BAL (PaO2/FIO2 <100, risk of~               bronchoscopy-related haemorrhagic complications), secondary exclusion of patients~               with negative cultures, defined by a threshold of bacteria <104 CFU/ml.~        -  Interventions:~      BAL samples will be cultured by standard methods and the minimal inhibitory concentration~     (MIC) of bacteria to the usual antibiotics will be determined using standard procedures. At~     the time of BAL collection, a rapid antibiogram will be performed by placing E-test~     antibiotic strips (AB Biodisk) directly onto Mueller-Hinton agar plates seeded with the BAL~     specimen (both by flooding and swabbing). E-test strips will be impregnated with cefoxitin,~     piperacillin-tazobactam, cefepime, imipenem, ciprofloxacin and amikacin. At 24 h, the E-test~     plates will be photographed and then examined separately by both a bacteriologist and a~     medical ICU physician following a consensus method. The final E-test results will be compared~     with the standard MIC cultures.~   "
192813|NCT01040468|"~     This research study will investigate the safety and effectiveness of weight loss surgery for~     overweight persons with type 2 diabetes. Eligible patients will undergo one of 2 types of~     weight loss surgery, Roux-en-Y gastric bypass, or laparoscopic adjustable gastric banding, or~     an intensive lifestyle modification. Participants will be closely followed for one year to~     compare the effects of these treatments on diabetes remission.~   "
192673|NCT01042340|"~     Background and aims:~      Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on~     energy intake and appetite were studied.~      Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were~     randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care~     (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and~     was distributed at the regular medication rounds. Food intake and self-rated appetite were~     registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional~     risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.~   "
192674|NCT01042327|"~     Today, haemodialysis is a recognized standard treatment for patients with chronic kidney~     disease stage 5. During the haemodialysis treatment session, blood passes from the patient~     through the extracorporeal circuit and is then returned. The dialyzer represents the greatest~     surface are of the extracorporeal circuit, as dialysis treatment is essentially based on the~     removal of small molecular weight solutes down along a concentration gradient, and this~     depends upon surface area. The ELISIO-H dialyzer differs in design to our current standard~     dialyzer, the FX100, by having fibers of a greater internal diameter, which potentially~     allows more internal haemofiltration, leading to an improved clearance of larger molecular~     weight solutes. It is now thought that these so called middle molecular weight solutes are~     more important in contributing to the clinical condition termed azotaemia, rather than~     smaller solutes such as urea.~      The investigators therefore wish to study the clearance of middle sized molecules between the~     different dialyzers.~   "
192675|NCT01042314|"~     The purpose of this study is to find out if the plasma concentration of donepezil is changed~     when BMS-708163 is administered at the same time~   "
192676|NCT01042301|"~     The Lymphoscreen study aims to characterize precisely (phenotypes/cytokines/functions) CD8+~     T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are~     needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic~     approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization~     of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2~     beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by~     autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in~     humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1~     Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and~     autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or~     humoral markers of the disease (such as serum miRNA).~   "
192677|NCT01042288|"~     The purpose of this multicenter, Phase II trial is to examine the role of a well-tolerated~     novel agent, panitumumab, in combination with a modern platinum doublet regimen using~     carboplatin and pemetrexed, in patients with advanced non-squamous wild type K-ras~     non-small-cell lung cancer (NSCLC). If this treatment proves to be well tolerated and~     associated with efficacy, this would provide rationale for further randomized studies.~   "
192678|NCT01042275|"~     Midurethral tapes are by now standard procedure in the surgical treatment of women with~     stress urinary incontinence. While the retropubic TVT is well documented with long-term~     results up to 11 years and continence rates of 90 %, the published data for the transoburator~     tapes (TO) cover follow-up of 3 years only. So far, all tapes establish continence~     effectively. Recently, the detailed 27-item Incontinence Outcome Questionnaire (IOQ) was~     constructed to assess patient-reported outcome and quality of life after insertion of a~     midurethral tape and validated for the German language. The aim of this study was to evaluate~     patient-reported mid- and long-term outcome after insertion of tension-free vaginal tape~     (TVT), transobturator sling, outside-in (TOT) and tension-free transobturator tape,~     inside-out (TVT-O).~   "
192679|NCT01042262|"~     When exposed to oxygen immediately after birth, newborns suffer from an oxidative stress with~     a significant decrease in serum concentration of the anti-oxidant enzyme superoxide~     dismutase. This oxidative stress has been consequently linked to the development of adverse~     outcomes in both premature and full term infants. In this study, we examined the effect of~     oxygen administration to delivering mothers immediately before and during labor on the~     newborn. In this randomized trial, we planned to measure superoxide dismutase in the~     umbilical cord blood when mothers received and did not receive oxygen..~   "
192680|NCT01042249|"~     The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on~     Lower Urinary Tract Symptoms (LUTS) in men after stroke.~      120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment~     group or a control group. The subjects in the treatment group follows a 12 week standard PFMT~     program, while the control group is not given specific treatment of their LUTS but like the~     treatment group follows the standard rehabilitation program for stroke patient. Outcome are~     measured by~        -  5 questionnaires~        -  Voiding diary~        -  24-hour pad test~        -  pelvic floor muscle assessment test~   "
192681|NCT01042236|"~     The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the~     treatment of the condition of stress urinary incontinence~   "
192682|NCT01042223|"~     Laryngomalacia is the most common congenital laryngeal anomaly and the most frequent cause of~     stridor in infants and children. Symptoms usually appear within the first 2 weeks of life.~     Its severity increases up to 6 months. 15-60% of infants with laryngomalacia have synchronous~     airway anomalies.~   "
192683|NCT01042210|"~     The study is focused on the investigation of possible associations between plasma/serum~     levels of agouti related peptide (AgRP) and its genetic background in healthy women with~     physiological pregnancy (non-preeclamptic) and women with preeclampsia, in the postpartum~     period, and in their offspring.~   "
192684|NCT01042197|"~     The purpose of this study is to investigate the relation between vitamin D production after~     UVB and exposed body surface areas with different UVB doses.~   "
192721|NCT01041716|"~     Carbapenems are a class of antibiotic agents which kill a broad spectrum of bacteria.~     Infections due to gram-negative bacteria which have acquired resistance to carbapenems are~     increasing, especially with Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas~     aeruginosa . The optimal treatment of such infections is not known. Antibiotics like~     polymyxin, tigecycline and rifampin are used alone or in combination with other antibiotics.~     The outcome of using these new and old drugs is not well studied. This observational study~     aims to study the clinical and microbiological outcomes of these infections and treatment at~     our institution.~   "
192685|NCT01042184|"~     Background: Helicobacter pylori infection has been shown to be associated with the~     development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection~     could reduce the occurence or recurrence of these diseases. However, the eradication rate of~     clarithromycin-based triple therapy has been declining in recent years, probably related to~     the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients~     would fail from first line standard eradication therapy and need second line rescue therapy.~     About 15-30% of patient would fail from second line therapy and need to be rescued with third~     line therapy. In recent years, the concept of sequential therapy has been advocated in the~     treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days,~     followed by a PPI plus clarithromycin and tinidazole for another five days. The eradication~     rate in the first line treatment of sequential therapy had been reported to be as high as~     90%. More importantly, it has been demonstrated that the eradication rate among patients with~     clarithromycin-resistant strains could be as high as 89%. However, tinidazole is not~     available in many countries. Whether metronidazole would be an effective alternative to~     tinidazole in the sequential therapy remains unknown. Besides, whether extending the duration~     of sequential therapy from 10-day to 14-day would result in higher eradication rate also~     deserves further investigation. Furthermore, data on the efficacy of rescue regimens for~     patients who failed from first line sequential therapy are also lacking. The impact of~     clarithromycin, metronidazole resistance and CYP2C19 polymorphism on the sequential therapy~     containing metronidazole (rather than tinidazole) also has not been reported.~      Aims: Therefore, we aim to assess~        1. whether the substitution of metronidazole for tinidazole in the sequential therapy is~          also more effective than clarithromycin-based triple therapy~        2. whether extending the duration of sequential therapy from 10-day to 14-day would achieve~          higher eradication rate~        3. whether levofloxacin-based sequential therapy for 14-days is effective as second line~          rescue regimen for those who failed from first line sequential therapy~        4. the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of~          sequential therapy~   "
192686|NCT01042171|"~     Confocal laser endomicroscopy (CLE) is a newly developed endoscopic technique. The most~     commonly used fluorescent substance is Fluorescein sodium.The plasma half-life of ﬂuorescein~     is 11 minutes. A recent test estimated that ﬂuorescein-based CLSM(confocal laser scanning~     microscopy) of the upper-GI tract of pigs delivers the best contrast and image quality within~     the ﬁrst 8 minutes after injection of ﬂuorescein .However, despite its increasing use in~     clinical examination,there are no data on contrast dynamics and image quality over time after~     injection of the ﬂuorescein sodium in the inspection of gastrointestinal tract of human~     being.~   "
192687|NCT01042158|"~     This will be a 36-week, single group, open label study assessing the effects of Tadalafil~     plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension~     associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such~     as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and~     hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV~     function including the transthoracic echocardiogram parameter tricuspid annular plane~     systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed~     by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns~     and to provide optimal efficiency and active therapy to all study subjects. It also allows~     for comparisons between the two monotherapies and with combination therapy.~   "
192688|NCT01042145|"~     This randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for~     3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate~     croup. It was conducted in a practice-based research network of community pediatricians in~     the St. Louis area. Outcomes included additional health care for croup, duration of symptoms,~     nights of disturbed sleep, parental stress, missed work days, and adverse events. Our~     hypothesis was that community-based treatment of children with mild or moderate croup with~     multiple doses of prednisone is superior to a single dose of dexamethasone.~   "
192689|NCT01042132|"~     To what extent the cardiopulmonary and inflammatory response is affected by initial femoral~     intramedullary nailing in the already traumatized and inflammatory activated patient was~     analyzed in the present study with the attention to survey the additional burden of this~     operative treatment. The patients are monitored with a pulmonary catheter, and blood samples~     for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and~     postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is~     compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared~     with a standard reaming technique (TR).~   "
192690|NCT01042119|"~     The neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment~     of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy~     than known from the use in striated muscle.~      The aim of our study is to analyze short- and longterm efficacy after Botox treatment and to~     evaluate risk factors for non-responders and side effects such as urinary retention.~   "
192691|NCT01042106|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes~     mellitus and healthy adults.~   "
192692|NCT01042093|"~     The purpose of this study is to compare different medication combinations used in a~     periarticular injection after total knee replacement surgery(TKR). A periarticular injection~     is an injection that is given into the tissues surrounding the knee joint. The injection is~     given while the patient is still in surgery.~      The study will compare the level of pain management, length of hospital stay, range of motion~     and side effects from subjects receiving one of four different combinations of medication in~     a periarticular injection. The medications used in the injections are approved medications~     routinely used for pain management.~      Approximately 160 subjects will participate in this study. The surgeon, study personnel, and~     patients will be blinded to the combination of medications each patient receives. The~     pharmacist will prepare the 4 different combinations of medications, randomize each patient~     to the particular combination of medications, and maintain the study drug documentation.~   "
192693|NCT01042080|"~     NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in~     proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier~     than airflow or pressure variations in the airway. The investigators hypothesized that NAVA~     improved patient-ventilator synchrony and reduced inspiratory workload as compared with~     pressure support ventilation delivered at two different cycling criteria (25 and 50 %).~   "
192694|NCT01042067|"~     The study is a national multicenter prospective observational study, including 200 patients.~     The main purpose of this study is to explore in more detail the influence of genetic~     variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on~     warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of~     treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K~     dependent proteins predict dosing and adverse events during warfarin treatment. The main aim~     is to individualize warfarin therapy and establish a treatment algorithm based on genotype~     and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.~   "
192832|NCT01040221|"~     The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and~     effective in treating adults with autism spectrum disorder~   "
192695|NCT01042054|"~     The provision of adequate pain relief following major liver surgery is essential, not only~     for patient comfort, but for the prevention of complications, such as chest infection.~      Commonly, pain relief in the first few days after surgery is provided by epidural analgesia.~     Drugs are delivered to the area around the spinal cord, through a fine plastic tube placed in~     the patients back, and this blocks sensation from the abdomen downwards, thereby providing~     effective pain relief without the need for opiate analgesia (e.g. morphine). Opiate analgesia~     can cause nausea, drowsiness and constipation, and its use should be minimised. Epidurals,~     however, can be associated with some problematic side effects. Low blood pressure is commonly~     encountered, and not only can its treatment be associated with complications, but patients~     are often confined to bed.~      Mobility can also be limited if muscle function in the legs, (in addition to sensation), is~     inadvertently affected by the epidural drugs. Other problems associated with epidural use are~     the relatively common failure of the technique to provide adequate analgesia (20%), and some~     extremely rare but potentially disastrous complications of epidural insertion.~      An alternative technique, is the provision of pain relief directly into the wound, via one or~     more multi−holed tubes(catheters), placed either in or close to the wound. This technique~     alone does not provide as effective analgesia as a functioning epidural, but when combined~     with other intravenous or oral analgesia, has been shown to be effective following a variety~     of surgical procedures.~      It is hypothesised that, following major liver surgery, the use of this latter technique may~     result in superior outcome and faster recovery, when compared with epidural, by avoidance of~     the side effects and complications discussed above.~      In this study, patients scheduled to undergo major liver surgery at the Royal Infirmary of~     Edinburgh with be randomly assigned to receive the first two days of pain relief either by~     epidural, or by wound catheter plus additional analgesia. Both groups will then receive an~     identical oral analgesic regime for the remainder of the hospital stay.~      Outcomes of interest will include the quality of pain relief attained, patient mobility,~     frequency of complications, and overall recovery time.~   "
192696|NCT01042041|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Chemoembolization kills tumor cells by blocking the~     blood flow to the tumor and keeping chemotherapy drugs near the tumor.~      PURPOSE: This phase I trial is studying side effects and best dose of sorafenib tosylate when~     given together with chemoembolization in treating patients with unresectable liver cancer.~   "
192697|NCT01042028|"~     This is an open multicenter randomized phase I/II study. The main purpose with this study is~     to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus~     given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER~     progression from 1. line treatment with Gemcitabine.~   "
192698|NCT01042015|"~     The goal of this study is to rapidly cool trauma victims who have suffered cardiac arrest~     from bleeding with a flush of ice-cold sodium chloride to preserve the patient to enable~     surgical control of bleeding, followed by delayed resuscitation with cardiopulmonary bypass.~   "
192699|NCT01042002|"~     Exercise training is proved to protect against premature cardiovascular mortality.~     Additionally there is evidence that relatively high exercise intensity may be an important~     factor for improving aerobic capacity and endothelial function in patients with~     post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in~     overweight and obese individuals.~      The aims of this study is to investigate if High-intensity exercise before a gastric bypass~     operation will decrease hospitalization days and complications after the gastric bypass.~   "
192700|NCT01041989|"~     This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention~     study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons~     at an increased dementia risk. The 2-year multi-domain life-style intervention includes~     nutritional guidance, exercise, cognitive training, increased social activity, and intensive~     monitoring and management of metabolic and vascular risk factors. The primary outcome is~     cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and~     Stroop and Trail Making tests to capture early cognitive impairment typical for both~     Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention~     will reduce cognitive impairment in the study group compared to the control group during the~     initial 2-year intervention period and reduce dementia incidence after the 7-year extended~     follow-up.~   "
192701|NCT01041976|"~     The purpose of this study is to compare 6 monthly counseling sessions to 6 monthly~     information sessions on Veterans' decisions to (a) participate in vocational rehabilitation~     services and (b) become employed.~   "
192702|NCT01041963|"~     A prospective, randomized, open-label, Single-center clinical trial to determine whether~     Enalapril or Enalapril plus Losartan effect on Peritoneal membrane transportation.~   "
192703|NCT01041950|"~     The purpose of this study is to determine if usage of early lumbar drainage leads to less~     shunt surgery and less catheter associated complications in patients with communicating~     hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.~   "
192704|NCT01041937|"~     The primary purpose of TKA Randomized Clinical Trial- Cemented versus Cementless Tibial~     Prosthesis Study will determine whether there is a significant difference in patient-reported~     and measured clinical outcomes (e.g. pain, function, length of recovery, and patient~     satisfaction) between subjects treated with a cementless tibial prosthesis (the cementless~     group) and those treated with cemented tibial prosthesis (the cement group) over the first~     two postoperative years. Radiographs will be assessed before surgery and at established~     post-operative intervals to determine if there are any significant differences between~     patients in the two groups and to assess the influence of component fixation on radiographic~     stability over time. Complication and revision rates will also be assessed for comparison.~   "
192718|NCT01041755|"~     Hepatic encephalopathy is caused by the effects on the brain of substances that under normal~     circumstances are efficiently metabolized in the liver. The hyperammonemia is the main factor~     responsible for the development of hepatic encephalopathy. In patients with cirrhosis, the~     reduction in hepatocellular function and generation of portosystemic shunts contribute to~     increase serum ammonium. The current therapeutic approaches, are aimed at reducing blood~     ammonium levels.~      Administration of the non-absorbable disaccharides, have become standard treatment of hepatic~     encephalopathy.There are no adequate clinical trials comparing the efficacy of~     L-Ornithine-L-Aspartate (LOLA) infusion against lactose enemas in the treatment of acute~     hepatic encephalopathy.~   "
192719|NCT01041742|"~     Pulse pressure variation (PPV) known as a dynamic preload index is increasingly being used~     for guide of fluid management under various clinical situations. We hypothesized that PPV~     could play a role as a predictor of fluid responsiveness during displacement of the heart in~     patients undergoing off-pump coronary artery bypass surgery (OPCAB).~   "
192705|NCT01041924|"~     Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide~     (CO2) in the blood. In heart failure, where the heart muscle is damaged and therefore does~     not pump as well, this reflex is exaggerated. The result is a vicious circle: blood CO2~     levels fluctuate wildly and as a result breathing also fluctuates with patients~     hyperventilating at times and briefly stopping breathing at others. During sleep this is~     called central sleep apnoea (CSA).~      Patients with CSA wake up throughout the night and whilst some patients are oblivious to~     this, others are consciously breathless and many patients are tired during the day and feel~     unable to perform their daily activities.~      As part of the body's stress response to the erratic pattern of breathing, both blood~     pressure and heart rate may rise to a level that is harmful in a failing heart, exacerbating~     the underlying heart failure. Indeed patients who demonstrate this CSA die sooner than those~     who have heart failure and stable breathing.~      There are no proven specific therapies for CSA that stabilise breathing, improve sleep~     quality, and prolong life. We have designed a system which delivers very small doses of CO2,~     when the blood level of CO2 is predicted to be low. During short daytime recordings, using~     this system, we have demonstrated that it is possible to stabilise the body's CO2 levels.~      We aim to test what happens when CO2 is given overnight whilst the patient is sleeping to see~     whether we can stabilise their breathing over longer durations and whether sleep quality~     could be improved so that patients are less tired during the day. In addition, we would like~     to measure whether the stress response is lessened if the breathing is successfully~     stabilised.~   "
192706|NCT01041911|"~     The purpose of this study is to determine the safe and efficacious dose of Euphorbia~     prostrata for control of per rectal bleeding in patients with first and second degree~     hemorrhoids.~   "
192707|NCT01041898|"~     The overarching hypothesis of this proposal is that obesity and positive energy balance in~     children promote both low bone mass accrual and risk for diabetes through events that are~     mechanistically associated and that involve bone as an endocrine organ. Recent studies~     conducted in mice have uncovered the presence of a unique bone-fat-pancreas axis that~     regulates energy homeostasis, coordinates energy partitioning between bone and adipose~     tissue, and impacts insulin sensitivity. The adipocyte-derived hormone leptin, elevated~     levels of which reflect both adiposity and positive energy balance, inhibits bone formation~     via sympathetic activation. Decreased bone formation in turn depresses insulin sensitivity~     and secretion via decreased production of undercarboxylated osteocalcin (unOC), a novel~     bone-derived hormone. Although data from mice are compelling, this novel pathway has not been~     widely tested in humans. Sparse data from adult men and women suggest that this axis is~     active in humans, and that unOC is regulated in part by exercise. No data are available~     regarding the bone-fat-pancreas axis in children. Because the foundations of body composition~     trajectories and metabolic programming are established early in the life course, childhood,~     particularly during early stages of growth and development, is an especially salient time~     period for evaluating the bone-fat-pancreas axis. With this pilot grant, we propose to gather~     evidence that these interrelationships exist in children. The data from this project will be~     used to prepare an NIH R01 proposal to conduct a lifestyle-based intervention in children~     aimed both at reducing risk for osteoporosis and type 2 diabetes, and at identifying the role~     of unOC in metabolism and tissue partitioning.~      Hypothesis 1: Obesity and positive energy balance in children decrease bone mass via elevated~     leptin.~      Specific Aim 1: Determine the association between bone mass by DXA and serum leptin~     concentration in lean and obese children. We predict that body weight will be positively~     associated with bone mass, but that at any given body weight, bone mass will be lower in~     obese children, and that this difference will be explained by leptin.~      Hypothesis 2: Leptin-mediated suppression of unOC decreases insulin secretion through action~     on the β-cell, and decreases insulin sensitivity by inhibiting secretion of adiponectin from~     adipose tissue.~      Specific Aim 2: Determine the association between insulin secretion during oral glucose~     tolerance test (OGTT; from C-peptide modeling) and serum unOC in lean and obese children.~     Determine the association between insulin sensitivity during OGTT (derived from mathematical~     modeling) and serum unOC in lean and obese children. Obese children are less insulin~     sensitive, and in an absolute sense, secrete more insulin. However, we predict that at any~     given degree of insulin sensitivity, insulin secretion will be lower in obese children, and~     that this difference will be explained by unOC. unOC will be inversely associated with serum~     leptin, and will be positively associated with adiponectin and insulin sensitivity.~      Hypothesis 3: Physical activity prevents leptin suppression of unOC and partitions energy~     towards bone mineral at the expense of bone marrow adipose tissue.~      Specific Aim 3: Assess the interrelationships among physical activity using accelerometry,~     bone mass using DXA and bone marrow adipose tissue using magnetic resonance imaging. We~     predict that at any given level of serum leptin, active children will have greater unOC.~     Further, we predict that at any given body weight, active children will have greater bone~     mass and lesser bone marrow adipose tissue than inactive children.~   "
192708|NCT01041885|"~     The purpose of this study is to investigate whether the INSTRUCT therapy is safe and~     effective in the treatment of cartilage defects of the knee.~   "
192709|NCT01041872|"~     The objective of this study is to evaluate the influence of different propofol~     formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with~     lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index~     target of 50.~   "
192710|NCT01041859|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally~     administered tapentadol extended release (ER) at dosages of 100 to 250 mg twice daily~     compared with placebo in patients with moderate to severe pain due to chronic, painful~     diabetic peripheral neuropathy (DPN) who tolerated tapentadol (ER) and have an initial~     treatment effect (pain improvement) after a 3-week, open-label titration period.~   "
192711|NCT01041846|"~     The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen)~     intravenous injection in patients with Myelodysplastic Syndrome.~   "
192712|NCT01041833|"~     BACKGROUND Platinum-based chemotherapy (CT) is the standard treatment for advanced~     non-small-cell lung cancer (NSCLC). Unfortunately, the survival and response rate (RR) to CT~     is poor. There is great interest in new treatment strategies. One of this new strategies~     include the use of retinoids such as atRA. The synergistic effect of cytotoxic agents with~     retinoids has been demonstrated in lung cancer. At the INCan, our work group carried out a~     phase II study trial that included 107 patients with advanced NSCLC. They were randomized to~     receive atRA (20-mg/m2) or placebo combined with 80 mg/m2 of cisplatin and 175 mg/m2 of~     paclitaxel. The results showed a significant increase in the RR of the atRA group, reaching~     55.8% ( 95% CI; 46.6-64.9%) compared with 25.4% (95% CI, 21.3-29.5%; p = 0.001) in patients~     who received placebo. Median Progression-free survival (PFS) in the atRA group was 8.9~     months, while for those of placebo, PFS was 6.0 months (p = 0.008). There were no significant~     differences in the grade 3-4 side effects between groups, except for hypertriglycemia, which~     presented with greater frequency in the atRA group (p = 0.05). Immunohistochemical stains~     determine the RAR B2 expression in 6 of 60 tumor samples analyzed; however, all samples~     expressed RAR B2 in adjacent normal tissue.~      HYPOTHESIS Patients with NSCLC who receive the scheme combined with first-line CT plus 45~     mg/m2 of atRA will have a greater PFS and RR to CT with an acceptable toxicological profile.~      OBJECTIVES~        1. Obtain a greater RR to CT and PFS in patients with advanced NSCLC who receive cisplatin-~          and paclitaxel-based CT combined with a 45-mg/m2 daily dose of atRA with an acceptable~          toxicological profile .~        2. Evaluate the benefit of RAR beta and RAR alfa expression as a response biomarker.~      METHODS Three hundred and thirty patients with advanced NSCLC will be included to receive~     Paclitaxel 175 mg/m2 and Cisplatin 80 mg/m2 (PC) every 21 days for 6 cycles. Patients will be~     randomized to receive ATRA 45 mg2/day or placebo 1 week before treatment until completing six~     cycles. Imaging studies will be performed prior and after two cycles of CT to assess~     response. RAR beta and RAR alfa expression will be analyzed by immunohistochemistry in lung~     tumoral tissue and in the adjacent lung tissue.~   "
192713|NCT01041820|"~     Early childhood (~3-7 years of age) is an important window for determining body composition~     trajectory and may be a critical period for the development of tissue partitioning patterns~     that influence obesity risk. As adiposity accelerates during this critical period,~     deposition/ preservation of fat stores may be sustained at the 'expense' of other tissues;~     i.e. energy homeostasis may be inherently biased toward fat gain. The type and amount of~     tissue mass accrued in early childhood has implications for metabolic profile,~     glucose/insulin homeostasis, hormone profile and resting energy expenditure.~      The interplay between fat and bone deposition represents a physiologic trait enabling the~     body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly~     the phenotype underlying obesity and diabetes risk may be determined by the differentiation~     of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development.~     In vitro studies demonstrate transdifferentiation under the influence of specific external~     stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have~     demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass~     accrual in adulthood, even when the stimulus is later removed (animals are no longer~     exercising). Children's early experiences (engagement in physical activity vs. sedentary~     behavior) may 'environmentally induce' alterations in body composition and predispose~     individuals to obesity throughout life.~      Aim 1. To examine the associations between body composition via DXA and objectively-measured~     physical activity/inactivity.~        1. Hypothesis 1.1: There is a positive association between physical activity and bone mass.~        2. Hypothesis 1.2: There is a positive association between sedentary behavior and total fat~          mass.~           Aim2. To examine the associations between adipose tissue distribution via MRI and~          objectively-measured physical activity/inactivity.~        3. Hypothesis 2.1: There is an inverse association between physical activity and bone~          marrow adipose tissue.~        4. Hypothesis 2.2: There is a positive association between sedentary behavior and bone~          marrow adipose tissue.~   "
192714|NCT01041807|"~     This survey is conducted for preparing application material for re-examination under the~     Pharmaceutical Affairs Law and its Enforcement Regulation; its aim is to reconfirm the~     clinical usefulness of COZAAR XQ through collecting the safety and efficacy information~     according to the Re-examination Regulation for New Drugs.~   "
192715|NCT01041794|"~     Early childhood (~4-6 years of age) is an important window for determining body composition~     trajectory and may be a critical period for the development of tissue partitioning patterns~     that influence later disease risk, including obesity and type 2 diabetes. As adiposity~     accelerates during this critical period, deposition/ preservation of fat stores may be~     sustained at the 'expense' of other tissues; i.e. energy homeostasis may be inherently biased~     toward fat gain. The type and amount of tissue mass accrued in early childhood has~     implications for metabolic profile, glucose/insulin homeostasis, hormone profile and resting~     energy expenditure.~      The interplay between fat and bone deposition represents a physiologic trait enabling the~     body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly~     the phenotype underlying obesity and diabetes risk may be determined by the differentiation~     of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development.~     In vitro studies demonstrate transdifferentiation under the influence of specific external~     stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have~     demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass~     accrual in adulthood, even when the stimulus is later removed (animals are no longer~     exercising). Children's early experiences (engagement in physical activity) may~     'environmentally induce' alterations in body composition and predispose individuals to~     diabetes throughout life (Figure 1).~      Hypotheses and Specific Aims: Early growth patterns and cell differentiation may induce long~     term effects on body composition by impacting biological and hormonal axes that regulate~     childhood body composition. Body composition comprises not only absolute mass, but also~     aspects of size, shape and location. To that end, the following specific aims will be~     evaluated:~        1. Quantify body composition, adipose tissue distribution, and relative tissue ratios using~          magnetic resonance imaging (MRI) and dual-energy x-ray absorptiometry (DXA).~             1. Hypothesis: Early partitioning of 'resources' toward fat mass accrual will lead to~               decreased gains in bone mass that may persist long-term.~             2. Hypothesis: Partitioning of tissue toward fat at the expense of bone mass (and~               indirectly, lean mass) will result in adverse effects on glucose/insulin~               metabolism, total energy expenditure, resting metabolic rate and hormone signaling.~             3. Hypothesis: Children with greater levels of physical activity (energy expenditure)~               will have greater partitioning towards bone (and lean) mass.~        2. Quantify adipose tissue distribution and adipocyte cell size and number using MRI and~          histological techniques.~             1. Hypothesis: A relatively greater amount of bone marrow adipose tissue will be~               apparent in those children with low levels of physical activity, resulting in the~               preferential differentiation of pluripotent stem cells towards adipocytes vs~               osteocytes in the bone marrow cavity.~             2. A relatively greater adipocyte cell number will be apparent in those children with~               low levels of physical activity indicating greater differentiation of MSC towards~               adipocytes vs osteocytes.~   "
192716|NCT01041781|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more~     effective with or without celecoxib in treating non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed~     disodium, and carboplatin to compare how well they work when given together with celecoxib or~     a placebo in treating patients with advanced non-small cell lung cancer.~   "
192722|NCT01041690|"~     Reports of the use of intravitreal bevacizumab (Avastin, Genentech) for the reduction of~     neovascularization in proliferative diabetic retinopathy have demonstrated significant~     regression in the number of new vessels. Reducing the vascularity of neovascular~     fibrovascular tissue can potentially reduce bleeding intraoperatively and thus facilitate the~     vitrectomy procedure. The investigators chose to investigate the potential benefit of the use~     of preoperative bevacizumab in the management of these most complex cases.~   "
192723|NCT01041677|"~     This study investigates the safety of 12 weeks of treatment with R256918, in obese patients~     (JNJ-16269110 and R256918 are different names for the same molecule). The primary objective~     of the study is to investigate mean changes in Hepatic Triglyceride Content (HTGC), which is~     the fat content of the liver, from baseline to week 6 and 12 by 1H-Magnetic Resonance~     Spectroscopy (MRS), a specialized non invasive radiology test. Additional measures include~     body mass index (BMI), fasting glucose,lipid levels, and blood pressure. Safety assessments~     performed during the trial include laboratory tests, vital sign measurements, and adverse~     event reporting.~   "
192724|NCT01041664|"~     A key factor in the determination of body composition over the lifecourse is fat accumulation~     during childhood. Periods of life associated with the greatest changes in organ development~     and growth, i.e. early childhood, have the most significant effect on body composition,~     energy balance, and metabolism. Early childhood (age 3 to 7 years) represents a critical~     transition for the basis of adaptability in body composition, due to the rapid growth and~     development that occurs. Plausibly the phenotype underlying obesity and related health risk~     may be determined by body composition during this critical period.~      Our previous research in children has consistently indicated that HA children accumulate~     greater amounts of fat, particularly in the intra-abdominal compartment, even at similar a~     BMI, and lower bone mineral content relative to EA children. The reason for these differences~     in body composition over the lifecourse is not clear.~      Racial/ethnic differences in risk factors for health, including 'thriftiness' in body fat~     accumulation are often evident before the age of 7, suggesting that the racial/ethnic~     differences in energy utilization and subsequent fat storage may be accounted for by genetic~     make-up, the environment (e.g. diet), or an interaction of the two. The physiologic or~     behavioral process(es) that cause(s) certain children to take a trajectory towards obesity~     while others accrue less fat is not known. However, the economic decision of fuel utilization~     is a physiologic trait enabling the body to choose between shuttling 'energy' towards accrual~     of a particular tissue (e.g. bone vs. fat) and this trait likely has a genetic component.~     This genetic component may be embedded in fat storage capacity evolved from gene by~     environment interactions that promote thrift, particularly conserved in some populations.~     Although genetic background plays a role, it not known whether there is a relationship~     between genetic background, known candidate genes or candidate pathways and environmental~     contributors (e.g. diet) that impact body composition trajectory. Of central importance to~     our understanding of early fat mass accumulation in health disparities are the mechanisms~     that lead to chronic disease progression.~      It is likely that variations within candidate genes may have a differential impact on~     individuals based on their genetic background. It is also probable that body composition is~     influenced by many genes, often within the same metabolic pathways, with small individual~     effects. These genes may not be significantly associated individually, but when examined as a~     unit (in a candidate pathway or gene-gene interaction framework) the association becomes~     significant. Further, children's early environmental exposures (e.g. diet) may interact with~     both genetic background and variations in candidate genes along resulting in alterations in~     body composition that predispose HA to excess fat accumulation throughout the lifecourse. To~     that end, the following specific aims will be evaluated:~      Aim 1. To examine the associations between genetic admixture and body composition in children~     aged 3-7 years after controlling for dietary intake.~        1. Hypothesis 1.1: There is a direct association between Amerindian admixture and fat mass~          and in inverse association between Amerindian admixture and bone mass.~        2. Hypothesis 1.2: There is a direct association between energy intake and fat accumulation~          and the relationship will be particularly evident in individuals with a greater~          proportion of Amerindian admixture.~      Aim 2. To examine the associations between genetic admixture and bone marrow fat in children~     aged 3-7 years after controlling for dietary intake.~        1. Hypothesis 2.1: There is a direct association between Amerindian admixture and bone~          marrow fat.~        2. Hypothesis 2.2: There is a direct association between energy intake and fat accumulation~          in bone marrow and the relationship will be particularly evident in individuals with a~          greater proportion of Amerindian admixture.~      Aim 3. To examine the relationship between variation in candidate genes and pathways and~     Amerindian admixture controlling for dietary intake.~      a. Hypothesis 3.1: Amerindian admixture will be associated with variations in candidate genes~     and pathways known to be associated with fat accumulation.~   "
192725|NCT01041638|"~     This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18~     together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell~     transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18,~     may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim,~     may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin~     may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma~     cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal~     antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell~     transplant may be an effective treatment for neuroblastoma.~   "
192726|NCT01041625|"~     This study is designed to demonstrate to efficacy and safety of Apremilast 20mg oral~     administration twice daily over 12 weeks in subjects with moderate to severe lichen planus.~     The hypothesis is that the subjects will achieve a significant clinical improvement in their~     skin disease according to a specialized physician grading scale.~   "
192727|NCT01041612|"~     The purpose of this prospective, randomized multicenter study is to determine whether there~     is any difference in stent patency of covered metallic stents in terms of stent positioning,~     above and across the sphincter of Oddi, in malignant bile duct obstruction.~   "
192728|NCT01041599|"~     The investigators aim to investigate the relationship between albuminuria and arterial~     stiffness in diabetic patients, hypertensive patients and healthy subjects.~   "
192729|NCT01041586|"~     To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous~     upper lobe emphysema.~   "
192730|NCT01041573|"~     The primary objective is to assess the systemic and local safety profile of purified~     inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28~     days interval up to Month 7 after the first IC51 vaccination in a pediatric population from~     endemic regions.~   "
192731|NCT01041560|"~     The purpose of the study is to examine connections between muscle tones, strength and~     function after stroke.~   "
192732|NCT01041547|"~     The overall objectives of this study are to examine the relationships between circulating~     vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine~     whether vitamin D deficiency in African Americans (AA) and White Hispanics (WH) is~     responsible for ethnic differences in insulin sensitivity and hypertension in AA, WH and~     European Americans (EA), as well as mechanisms underlying the association between insulin~     resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with~     insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin~     sensitivity and vascular functioning in AA and WH relative to EA is due to lower circulating~     25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is~     mediated by 25(OH)D.~      Acronyms: African American (AA), European American (EA), White Hispanics (WH), Serum~     25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).~   "
192733|NCT01041534|"~     Our aim is to complete a survey study of patients who have undergone Adjustable Gastric Band~     (AGB) surgery at the University of Washington Medical Center (UWMC) and expanded to other~     bariatric surgical sites outside the University of Washington (UW), which will obtain a HIPAA~     waiver and a letter of cooperation) between April 1, 2007 and July 1, 2008. (Please note the~     University of Washington team will not have access to the site's list of patients, only~     access to coded returned surveys sent back from patients). Patients will be identified by~     obtaining operative case lists from the Department of Surgery Quality Improvement Team who~     maintain monthly records of bariatric procedures performed. We will obtain patient contact~     information (address) and patients will be contacted by mail with the request that they~     complete both the Adjustable Gastric Band (AGB) Health Survey and a standard Quality of Life~     survey (EQ5D). The mailing will include an Information Statement, the AGB Survey, the EQ5D,~     and a stamped return envelope. As an incentive, a $2 bill will be sent along with the first~     mailing to cover the costs of completing and returning the surveys. Patients who do not~     return survey within 30 days will be mailed a second survey. Patients who do not return the~     second survey within 30 days will be mailed a third survey. Patients who do not return the~     third survey will not be re-contacted.~   "
192734|NCT01041521|"~     The study seeks to determine if the use of omega three fatty acids in individuals infected~     with HIV and with high triglycerides leads to improved triglyceride levels, better blood~     vessel function and decrease in the amount of obstruction in blood vessels.~   "
192735|NCT01041508|"~     Stem cell transplant is an important therapeutic option for pediatric patients with relapsed~     or refractory leukemia. Although, full myeloablative transplants are widely used for patients~     with acute leukemia, myeloablative chemo-radiotherapy may not be feasible in some specific~     settings. These settings include 1) patients with pre-existing health issues and organ~     toxicities; 2) patients who have relapsed post-ablative transplant and need a second stem~     cell transplant; and 3) leukemia patients with advanced disease who have been heavily~     pre-treated. Clofarabine, a new purine nucleoside anti-metabolite, has the advantage of~     significant antileukemic activity in addition to its possible immuno-suppressive properties.~     In this study we plan to determine the maximum feasible dose (MFD) of Clofarabine in~     combination with total body irradiation that can achieve durable donor engraftment without~     causing excessive toxicity.~   "
192736|NCT01041495|"~     Amrix (Cyclobenzaprine hydrochloride Extended release capsules) is approved by the FDA as a~     muscle relaxant, indicated for the treatment of muscle spasm associated with acute, painful~     musculoskeletal conditions. Cyclobenzaprine ER (Amrix TM) has a distinct pharmacokinetic~     profile providing early systemic exposure and consistent plasma concentration over several~     hours. Overall, a single dose of Amrix 30 mg is similar to that of cyclobenzaprine immediate~     release 10 mg three times daily. This ER formula should improve compliance, with similar~     efficacy and possibly less side effects as is often the case with slower release~     formulations.~      There are clinical studies showing that cyclobenzaprine can alleviate pain secondary to~     Fibromyalgia induced muscle tone. This multi-layered evidence base suggests that~     cyclobenzaprine may be able to alleviate pain in fibromyalgia. Theoretically in fibromyalgia,~     pain is interpreted centrally and possibly occurs due to said muscle spasm . Cyclobenzaprine~     may relieve this pain, thus allowing patients to function better during the day and sleep~     better at night. Cyclobenzaprine has tricyclic antidepressant structure which may also allow~     pain signal dampening in the spinal cord as well, similar to amitriptyline which is used~     off-label for neuropathic pain as well.~      Fibromyalgia (FM) is an illness that may involve medical, rheumatologic, autoimmune, sleep,~     endocrine and psychiatric pathology. It is a syndrome of recurrent pain at trigger points.~     Greater than 90% of these patients will report fatigue as a key symptom as well. There are~     several investigation lines into the treatment of FM induced pain. Exercise, behavioral~     therapy, amitryptiline, duloxetine, tramadol, sodium oxybate, pregabalin all have randomized~     trials and almost all focus on pain. There are very few studies evaluating cyclobenzaprine~     and none studying to Cyclobenzaprine ER formulation. None evaluate pain reduction, sleep and~     fatigue improvement.~      Cyclobenzaprine is a drug with minimal adverse effects (dry mouth, dizziness, fatigue,~     constipation, somnolence, nausea, and dyspepsia). It may have a safer tolerability profile~     than some of the FM medications noted above. As cyclobenzaprine is often studied and often~     added as an augmentation agent to patients' regimens who suffer from acute painful~     musculoskeletal conditions, the authors feel that cyclobenzaprine would also be effective in~     this population. The authors wish to conduct a study to determine if cyclobenzaprine ER is~     safe and tolerable in the treatment of FM induced pain, and secondary fatigue and insomnia.~     This initial study may allow for continued regulatory studies with this product in FM~     subjects. The authors propose a double-blind placebo controlled study to determine if~     cyclobenzaprine ER is safe and effective in reversing FM induced pain, and secondary fatigue~     and insomnia.~   "
192737|NCT01041482|"~     A one-arm,open,multi-center study, to evaluate sorafenib (400mg twice daily ) as a adjuvant~     to prevent recurrence of RCC(renal cell carcinoma) patients after radical nephrectomy with a~     high-risk of recurring. To observe disease-free survival and the survival rate in 3 years,5~     years.~      The purpose of this study is:~        -  To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate~          in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.~        -  To observe the incidence of hand-foot skin reaction (HFSR) after the Urea (10% or 5%)~          based cream intervention treatment.~      The primary end point is the disease-free survival(DFS).The secondary end point is overall~     survival(OS),the drug safety and tolerance, the occurrence of hand foot skin reaction(HFSR)~     at the week of 3,6,12,the skin toxicity(not include HFSR) higher than CTCAE(Common~     Terminology Criteria for Adverse Events) Grade 2 at the 12th week, the incidence of HFSR~     after the Urea (10% or 5%) based cream intervention treatment.~   "
192738|NCT01041469|"~     The purpose of the study is to identify biological data linked to auto immune abnormalities~     associated with Down Syndrome.~   "
192739|NCT01041456|"~     The aim of this study is to describe the clinical presentation, indications, and operative~     treatment as well as assess the morbidity, mortality, and overall performance of revisional~     GBP after either failed and/or complicated Biliopancreatic Diversion BPD for weight loss.~     With such information, we hope to determine what features might assist us in advancing our~     knowledge about mechanisms of failure after primary bariatric surgery, mechanism of action of~     revisional GBP, and performance of revisional GBP through traditional outcome measurements as~     well as identifying predictors of good or poor outcome after revisional GBP in this specific~     subpopulation.~   "
192740|NCT01041443|"~     This phase I trial is studying the side effects and best dose of 5-Fluoro-2'-deoxycytidine~     (FdCyd) when given together with tetrahydrouridine (THU) in treating patients with acute~     myeloid leukemia (AML) or myelodysplastic syndromes (MDS). FdCyd may inhibit cancer cell~     growth by increasing the production in cells of compounds that suppress growth or by~     otherwise killing cells. Although FdCyd is stable as a drug solution, it is rapidly~     inactivated by an enzyme present in people. THU is included in the treatment to inhibit the~     enzyme, prolonging the time FdCyd remains in the body~   "
192741|NCT01041430|"~     The aim of the study was to evaluate the feasibility of day surgery for elderly patients~     undergoing elective open inguinal hernia repair. Medically stable patients aged 65 years or~     older, with postoperative care available at home, were randomized to receive treatment either~     as day-cases or inpatients. Younger day-case patients undergoing the same procedure served as~     controls. Outcome measures during two postoperative weeks were complications, unplanned~     admissions and visits to the hospital, unplanned visits to primary health care and patients'~     acceptance of the type of provided care. The investigators expected to find a higher degree~     of satisfaction in the patient group receiving day-case care.~   "
192742|NCT01041417|"~     Peripheral arterial disease is a common condition in older adults involving poor arterial~     circulation in the legs leading to leg pain and debility. The body's own circulating blood~     vessel stem cells may help to improve circulation. This study will test whether treatment~     with the drug granulocyte macrophage colony stimulating factor (GM-CSF) will improve symptoms~     and signs of peripheral arterial disease over placebo after four weeks of therapy. As well~     this study will examine whether improvements in blood vessel function can be observed.~     Finally, we will measure blood vessel function and stem cell levels in order to determine~     whether they can help to predict whether patients wither peripheral arterial disease will~     suffer further cardiovascular complications.~   "
192743|NCT01041404|"~     This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall~     survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the~     chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab~     (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg)~     every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800~     mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion~     every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks)~     and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab~     (Herceptin) will continue until disease progression. The target sample size is 300-600~     patients.~   "
192744|NCT01041391|"~     This study is being conducted to examine outcome measurements on patients who undergo surgery~     to removed a damage lumbar spine disc versus those that chose not to have surgery. These~     outcomes are based on patient responses to quality of life and pain questionnaires.~   "
192745|NCT01041378|"~     The purpose of this study is to evaluate postoperative pain control for pediatric patients.~   "
192746|NCT01041365|"~     The overall objectives of this study are to examine the relationships between circulating~     vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine~     whether vitamin D deficiency in AA is responsible for ethnic differences in insulin~     sensitivity and hypertension in AA and EA, as well as mechanisms underlying the association~     between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is~     associated with insulin sensitivity and vascular functioning, independent of adiposity, 2)~     lower insulin sensitivity and vascular functioning in AA relative to EA is due to lower~     circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular~     dysfunction is mediated by 25(OH)D.~      Acronyms: African American (AA), European American (EA), Serum 25-hydroxy vitamin D (25()H)D,~     Body mass index (BMI), Alabama (AL).~   "
192747|NCT01041352|"~     The aim of the study is to compare anaesthesia (for back surgery) using endotracheal~     intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal~     mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone~     position on the operation table) as regards advantages, adverse effects and time spent. The~     anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium).~     Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients~     18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an~     estimated duration of less than 2 hours.~      Adverse effects (related to the placement on the operation table i.e. pain in the arms or~     shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time~     spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence~     from the anaesthesia are registered. The hypothesis is that the method using the laryngeal~     mask is faster and with fewer adverse effects.~   "
192748|NCT01041339|"~     A blood test (2-3 cc peripheral venous blood) drawn /used from already available required lab~     tests to distinguish between pericarditis accompanied with electrocardiogram (ECG) signs~     mimicking infarction. A test of clinical potential if proven to be able to support either~     origin of acute chest pain etiology.~   "
192749|NCT01041326|"~     This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical~     prostatectomy for patients with high-risk localized disease. Its hypothesis is that such~     treatment will be well tolerated with similar side effect profile as surgery alone. Patients~     in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole~     pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a~     boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy,~     respectively. The patient will then undergo radical prostatectomy between 4-8 weeks after~     completion of radiation.~   "
192750|NCT01041313|"~     Pain is a common element of surgery. Opiates (morphine, oxycodone, hydrocodone, methadone,~     fentanyl) are very helpful in decreasing pain after surgery. Unfortunately, with repeated use~     opiates lose their effectiveness, such that patients need to utilize more opiates to achieve~     adequate pain relief - a phenomenon called tolerance. Sometimes tolerance to a pain~     reliever's effects can develop in just a few hours. It is thought that activation of the~     N-methyl d-aspartate (NMDA) receptor, a switch found on the surface of nerves, is partially~     responsible for opiate tolerance. Memantine is a medication that limits the activity of NMDA~     receptors in the brain and spinal cord. It has been used for years to help patients with~     Alzheimer's Disease. In this study, we will study the effects of memantine when combined with~     opiate medications to see whether it can increase the effectiveness of opiates for pain after~     surgery and reduce the side effects caused by opiates (e.g., sedation, nausea, itching).~   "
192751|NCT01041300|"~     Our aim is to Test the influence of a new multichanel Transcranial Magnetic Stimulation~     stimulator (Multiway) on motor excitation, in comparision to a wildly used Magstim Super~     Rapid 2 single channel stimulator.~      Each of the 20 Healthy subjects that are inticipated to inrole to the study wiil undergo 6~     simple procedures which are designed to compare the motor threshold obtained by diffrent~     combination of TMs coils (figure 8, double cone coil,H coil array) and stimulators (Multiway,~     Super Rapid 2).~      The entire length of the procedures is about 4 hours and all subjects will be paid for their~     participation in the study.~      Our main hypothesis is that the motor threshold obtained by the multichanel stimulator will~     be significtly lower then the single chanel stimulator.~   "
192752|NCT01041287|"~     Hypertension, or high blood pressure, is a common disease that affects many Americans, and~     can lead to devastating consequences such as heart attack, stroke, and death if not treated.~     Nebivolol is a medication that has been recently approved by the FDA for the treatment of~     hypertension. Nebivolol has an unusual profile compared to other medications, in that its~     effects may be related to release of a substance called nitric oxide. Nitric oxide is~     released from the cells lining the blood vessels, and nebivolol may stimulate these cells to~     release more nitric oxide. Our study will investigate whether treatment with nebivolol, as~     compared to another medication called metoprolol, in hypertensive subjects will be more~     effective in protecting blood vessels against the harmful effects of high blood pressure. The~     mechanisms we will investigate include oxidative stress markers and circulating levels of~     endothelial progenitor cells.~   "
192753|NCT01041274|"~     This study seeks to examine the effectiveness of citalopram added to treatment with any oral~     or injectable second-generation antipsychotic plus standardized psychoeducation in first~     episode schizophrenia patients. Because depressive symptoms are common in first episode~     patients, we will test the hypothesis that adding the SSRI citalopram to a pre-established~     medication regimen will improve quality of life and decrease relapse and suicidality over the~     course of a 12-month trial.~   "
192754|NCT01041261|"~     We propose to compare the standard of care with the use of a novel medical food in 6~     bariatric surgery patients by measuring outcomes of body composition, quality of life, hair~     loss, muscle strength, resting energy expenditure, and biochemical parameters.~   "
192767|NCT01041079|"~     The purpose of this study is to determine the feasibility, safety, and efficacy of revision~     gastroplasty along with other adjunct procedures in the treatment of intractable / chronic~     marginal ulcers after Roux-en-Y gastric bypass. A secondary aim is the identification of good~     and poor outcome predictors after revisional strategies for intractable or chronic marginal~     ulcer.~   "
192768|NCT01041066|"~     The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation~     of cardiovascular responses to endotracheal intubation.~   "
192755|NCT01041248|"~     Relapsing polychondritis (RP) is a rare, immune-mediated disease associated with inflammation~     in cartilaginous structures and other tissues throughout the body. Prognosis can be poor,~     especially in cases where there is acute involvement of the laryngotracheal cartilages~     leading to airway destruction, which are resistant to treatments such as corticosteroids,~     immunosuppressive or cytotoxic drugs. The pathogenesis remains unclear although it is thought~     that autoimmune reactions to antigens present in cartilages, such as type II collagen and~     matrilin may evoke symptoms. There are no known clinical or laboratory measures that predict~     the expression of specific disease manifestations or the overall disease course. Two recently~     published case reports have shown an association with elevated serum IL-6 levels and~     relapsing polychondritis. In these case reports, both patients with refractory relapsing~     polychondritis were treated with tocilizumab, a humanized monoclonal antibody to the~     Interleukin 6 receptor, and achieved sustained response to the drug. This single patient~     trial aims to evaluate the response to Tocilizumab in an eight year old boy with relapsing~     polychondritis who has been shown to have elevated serum IL-6 levels and who has responded~     poorly to conventional therapies. The study hypothesis is that Tocilizumab will be able to~     control the disease in this patient.~   "
192756|NCT01041235|"~     The purpose of this study is to determine the safety profile, including the maximum tolerated~     dose (MTD), of ATI-1123 a liposomal formulation of docetaxel, in the treatment of cancer~     patients with advanced solid tumors.~   "
192757|NCT01041222|"~     This study will test the safety, tolerability and pharmacokinetics of single doses of ISIS~     333611 administered into the spinal canal as 12 hour infusions.~   "
192758|NCT01041209|"~     The aim of this study is to test if BPS (Bacterial Pneumonia Score) guided antibiotic use in~     children with non severe community acquired pneumonia (CAP) will reduce antibiotic use as~     compared to standard care practice (current guidelines for CAP).~   "
192759|NCT01041196|"~     A common late complication after gastric bypass surgery is marginal ulceration that is~     defined as ulcers at the margins of the gastrojejunostomy, mostly on the jejunal side. Most~     marginal ulcers respond to medical therapy and complicated or complex ulcer disease warrants~     operative intervention; specifically, perforated, penetrated, obstructing, bleeding and~     intractable marginal ulcers require surgical intervention.~      Diverse operative strategies for addressing perforated marginal ulcers after gastric bypass~     have been described including I) Omental (Graham) patch repair, II) Revision of~     gastrojejunostomy, III) Irrigation and drainage, IV) any previous procedure with truncal~     vagotomy, V) Esophagojejunostomy, and VI) Reversal. We formally analyze our experience with~     the laparoscopic resection and repair of acutely perforated marginal ulcers after Roux-en-Y~     gastric bypass (RYGB), with or without concomitant resolution of technical risk factors for~     marginal ulceration.~   "
192760|NCT01041183|"~     Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of~     postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral~     and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.~   "
192761|NCT01041170|"~     Background: Rimonabant, a CB1 receptor antagonist, blocks effects of cannabinoids and, in~     dependent animals, elicits cannabinoid withdrawal. No studies have examined~     rimonabantelicited cannabis withdrawal in humans.~      Goals: (1) Determine the lowest single dose of oral rimonabant that elicits measurable~     cannabinoid withdrawal. (2) Characterize cognitive performance, subjective state,~     physiological condition, and regional brain activation (measured by functional magnetic~     resonance imaging [fMRI]) during acute and chronic administration of oral delta~     9-tetrahydrocannabinol (THC) and during cannabis withdrawal. (3) Characterize the~     pharmacokinetics of oral THC and metabolites in body fluids and hair and of rimonabant in~     plasma.~      Subject Population: Up to 60 completing cannabis users aged 18-45 (up to 24 in Experiment I,~     36 in Experiment II) and 18 completing non-drug-using controls (Experiment II). Enrollment~     target is 82% Caucasian, 14% African American, 4% other; 9% Hispanic; 35% women.~      Experimental Design and Methods: Experiment I: In this within-subject, randomized,~     double-blind, dose-escalation study, six participants receive 7 days of THC (40-120 mg/day).~     On Day 8, five participants receive 20 mg rimonabant; one receives placebo. If withdrawal~     criteria (greater than or equal to 150% or 2.5-fold increase in selected visual-analog~     scales) are not met in all five participants receiving rimonabant, separate groups of six are~     similarly treated with 40, 60 or 80 mg rimonabant, if necessary. The PI and MRP will submit~     all adverse events and relevant cardiovascular and scientific data to the IRB at the~     completion of each rimonabant dose panel. When the extramural NIDA DSMB is in place, it will~     review all data collected to date and develop and implement a monitoring plan, including~     review on completion of each dose cohort. DSMB recommendations will be reviewed by the~     Sponsor, Clinical Director and IRB before proceeding to the next dose cohort. In addition, if~     any subject has an intolerable adverse event (ie, an adverse event leading to study~     discontinuation) or serious adverse event in response to rimonabant on Day 8, the blind for~     that subject will be broken, and a report sent to the Sponsor, the extramural NIDA DSMB when~     in place and the IRB for discussion.~      Experiment II: In this randomized, placebo-controlled, double-blind study, 36 participants~     receive 7 days of THC (40-120 mg/day). On Day 8, 18 participants receive rimonabant dose~     determined in Experiment I to elicit cannabis withdrawal; 18 participants receive placebo~     rimonabant to evaluate spontaneous cannabis withdrawal. Cognitive, psychological,~     physiological and hormonal measures are monitored to determine onset, magnitude, and duration~     of THC intoxication and withdrawal and to correlate with THC and rimonabant pharmacokinetics.~     Changes in blood oxygen level-dependent (BOLD) signal are determined with five fMRI scans~     throughout the study. Eighteen non-drug-using controls undergo scanning and cognitive testing~     at similar intervals.~      Risks and Benefits: The proposed doses of THC and rimonabant have been well tolerated in~     other studies. The most common side effects of oral THC are sedation, cognitive impairment,~     euphoria, poor coordination, tachycardia, and hypotension. Spontaneous withdrawal from~     cannabis is mild and medically benign. Experience with other drugs suggests that~     antagonist-elicited cannabis withdrawal may have an earlier onset and greater intensity than~     spontaneous cannabis withdrawal. There are no clinical benefits to participants. Scientific~     benefits are greater understanding of cannabis intoxication, tolerance, and withdrawal and of~     the role of rimonabant in eliciting cannabis withdrawal.~   "
192762|NCT01041157|"~     The purpose of the study is to examine the effect of the botulinum toxin injection into~     muscle tone, strength and mobility with and without muscle exercise effect.~   "
192763|NCT01041144|"~     The purpose of this study is to investigate the effectiveness of the new diabetes care~     delivery system applied to preexisting public health care resources through advanced~     information technologies such as PDA-type glucometer and the Internet on the glycemic control~     of type 2 diabetes patients lived in isolated rural area.~      The investigators conducted a prospective, randomized, controlled trial in patients with type~     2 diabetes for 12 weeks. The intervention group was treated with the new health care delivery~     system, where diabetes center provided specialized management, mediated by nurse of primary~     health care posts using the Internet and the PDA-type glucometer, while the control group~     with conventional health care. HbA1c, fasting plasma glucose and lipids levels were measured~     at baseline and follow-up.~   "
192764|NCT01041131|"~     The main aim of this study is to analyze and report the intermediate term outcomes after~     laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated~     Vertical Banded Gastroplasty (VBG). The foremost outcome measurements are 1) Fat loss mainly~     measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL. 2) Trend in~     Comorbidity status. 3) Subjective Satisfaction and Health-Related Quality of Life HR-QoL~     are measured by a standardized, non-validated satisfaction questionnaire and by a validated,~     disease-specific worldwide used HR-QoL questionnaire. 4) Morbidity & Mortality include~     nutritional status and metabolic complications.~      Consequently, secondary objectives of this study are the following. 1) To assess failure rate~     defined as percentage of excess weight loss < 50%, lowest BMI >35 for morbidly obese (MO) or~     >40 for superobese (SO), and/or lack of resolution/improvement of major comorbidities at the~     point in time when assessed at each postoperative year after the surgery under study. 2) To~     evaluate the metabolic and nutritional status by measurements of particular clinical and~     biochemical parameters.~   "
192765|NCT01041105|"~     The goal of this study is to describe the clinical presentation, indications, and operative~     treatment as well as assess the morbidity, mortality, and overall performance of revisional~     Roux-en-Y gastric bypass (RYGB) after either failed or functional antireflux surgery ARS in~     obese patients. With such information, we hope to determine which features might assist us in~     advancing our knowledge about Gastro-Esophageal Reflux Disease GERD, the best option for~     primary ARS, and mechanisms of failure in the obese population as well as in identifying~     predictors of outcome after revisional surgery in this population.~   "
192766|NCT01041092|"~     Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic~     treatment to improve negative symptoms of schizophrenia in postmenopausal women.~      This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant~     treatment to antipsychotic treatment. Treatment period of 12 weeks.~      The primary result obtained is that women treated with 60 mg of raloxifene compared to those~     treated with a placebo show greater improvement in psychotic symptoms. The investigators also~     found improved response in some aspects of social functioning and neuropsychological~     functioning.~   "
192769|NCT01041040|"~     Prospective, multicenter, uncontrolled cohort study to analyze the efficacy of a risk adapted~     treatment strategy, including gemtuzumab ozogamicin (GO) during consolidation, for patients~     with acute myeloid leukemia (AML).~   "
192770|NCT01041027|"~     This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in~     treating patients with high-risk endometrial cancer. Radiation therapy uses high energy x~     rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing or by stopping them from spreading. Giving radiation therapy with~     chemotherapy may kill more tumor cells.~   "
192771|NCT01041014|"~     Numerous studies suggest that the use of in-person, professionally trained medical~     interpreters can reduce health care costs associated with diagnosing and treating patients~     with limited English proficiency. However, few studies have specifically addressed the~     question of the cost-effectiveness of language services in health care settings. This study~     used a randomized controlled study design to compare the cost-effectiveness of using~     professional interpreters with Spanish-speaking patients seen in hospital emergency~     departments (EDs) versus using the usual language services available to these patients. The~     main goal of the study was to estimate the effect that professional interpreters have on~     resource utilization and patient/provider satisfaction in the ED compared to the language~     services usually offered in these settings. Our hypothesis was that use of trained~     interpreters would lead to more cost-effective provision of ED services.~   "
192772|NCT01041001|"~     The purpose of the study is to assess and compare the safety and efficacy of the~     allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product (Cartistem®)~     to that of a microfracture treatment in patients with articular cartilage defect or injury.~   "
192773|NCT01040988|"~     The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has~     substantially changed the medical and surgical management of patients with cardiac rhythm~     disease. In the case of patients with ICDs, these devices are programmed to deliver a strong~     electrical shocks. In adults, multiple studies have suggested that patients at risk of~     receiving shocks from their device have an increased prevalence of anxiety and depression.~     Very few studies have looked at this question in children. We propose to evaluate a cohort of~     patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers, assessing~     each group for the presence of depressive and anxiety disorders, including post-traumatic~     stress disorder (PTSD).~   "
192774|NCT01040975|"~     The purpose of this study is to teach primary care physicians effective ways to counsel~     overweight and obese adolescent patients to attain a healthy weight. Fifty physicians and up~     to 660 adolescent patients from Duke University Health System (DUHS) Primary Care Clinics~     will take part in this study.~      Patients will be identified by research study staff and asked if they would be willing to~     have their clinic visit audio recorded for research purposes. There are three phases of data~     collection. First, baseline encounters (n=200, 4 per physician) are audio recorded. Then,~     half of the physicians will be randomized to receive a tailored web-based intervention~     containing information about evidence-based techniques to help adolescents attain a healthy~     weight. A new set of 200 encounters (4 per physician) will be audio recorded. Then, all~     physicians will receive a Summary Report that outlines the adolescent's high risk behaviors~     that contribute to weight (sweetened beverages, fast food, breakfast, physical activity,~     screen time, and sleep) and a new set of 200 encounters will be audio recorded.~      Data will be collected by trained data technicians, in-person and over the phone. Data is~     collected on laptop computers and then downloaded into password protected electronic files on~     a secure network server. All participants (adolescent patients and physicians) will be~     assigned a code number that is the sole identifier on all study data forms. Prior to and~     after coding, digital files will be stored in password protected directories to which only~     the data technicians and project manager have access. The web-based intervention will be~     password protected.~   "
192775|NCT01040962|"~     Fall risk is increased in people with diabetic peripheral neuropathy (DPN) and yet, minimal~     research has been conducted to identify appropriate fall risk assessment tools and improve~     our understanding of falls in these individuals. Purpose: The primary purpose of this study~     is to establish a foundation of knowledge needed to address falls in people with DPN. This~     will be accomplished through 1) comparing the validity of 4 fall risk assessment tools, 2)~     identifying risk factors for falls and 3) determining how quality of life is influenced by~     factors related to falls in people with DPN.~   "
192776|NCT01040949|"~     Smoking among Latino males living in the U.S. is a significant public health problem, one~     that can contribute to disparities in life expectancy and increase mortality. Latinos smoke~     at the same rate as White males but are less likely than Whites to quit. Interventions do not~     reach Latino smokers because many speak only Spanish and previous interventions have had~     notable limitations. First, most have recruited volunteers, so hard-to-reach Latino smokers~     likely did not participate. Second, cessation effects were short-term only. Third, no program~     has attempted to boost Latino cessation rates by capitalizing on a teachable moment, a time~     when quitting may seem especially relevant. To address these deficits, we propose to conduct~     a teachable moment intervention trial for Latino smokers. We will attempt to capitalize on~     the potential teachable moment of Latinas' pregnancy as an impetus for Latinos' cessation. We~     will include couples, rather than just men, to sustain intervention effects. We will partner~     with community leaders to develop an intervention based primarily on Social Cognitive Theory,~     the Teachable Moment Model, and the Cognitive-Behavioral Couple Therapy Model. Some elements~     will be at the individual level to help Latinos quit smoking and others will be couple-based~     to improve communication and reduce stress in the postpartum relationship. The program will~     be culturally sensitive to Latino values, such as familismo, valuing of and duty to the~     family and personalismo, valuing warm personal relationships. We will recruit Latino couples~     (n=366) into a Guia (control) arm in which men receive a culturally appropriate smoking~     cessation guide, and a couple-based smoking cessation counseling arm.~      Hypothesis 1: Latino expectant fathers who receive couple-based counseling to quit smoking~     will be more likely to be abstinent from smoking at 28 weeks in pregnancy and 12 months~     post-randomization than Latino expectant fathers who receive a self-help smoking cessation~     guide.~      Hypothesis 2: Couple-based counseling will improve mediators, such as couple communication~     about smoking, self-efficacy, outcome expectancies, stress levels, risk perceptions, emotion,~     and self-image, which in turn, will increase cessation rates among Latino expectant fathers.~      Hypothesis 3: Couples in the counseling arm will have a greater increase in cessation during~     pregnancy and a lower decrease in cessation at 6 and 12 months post-randomization than~     couples in the Guia arm.~   "
192777|NCT01040936|"~     PCI has been one of the most common choice of treatments for patients with coronary artery~     disease, and studies indicated that intensive statin treatment before PCI could reduce~     adverse events as comparing to the placebo. In China, statin with regular dose is currently~     applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we~     hypothesize that intensive statin treatment with arovastatin before PCI could further reduce~     clinical adverse events.~   "
192778|NCT01040923|"~     The study is designed to evaluate the predictive diagnostic accuracy of SonoMedica's~     CardioSond digital electronic stethoscope in the detection of coronary artery disease (CAD)~     in patients without known disease who are referred to cardiac computed tomography angiography~     (CT scans).~   "
192779|NCT01040910|"~     Background: The marijuana plant Cannabis has been used for centuries in the medicinal~     treatment of many disorders and is still the subject of medical research and public debate.~     Cannabinoids have been purported to alleviate a variety of neurological conditions such as~     MS-related symptoms including spasticity, pain, tremor and bladder dysfunction. Other~     neurological conditions like chronic intractable pain, dystonic movement disorders and~     Tourette's Syndrome were all reported to be alleviated by cannabis use. Cannabis has been~     used to treat anorexia in AIDS and cancer patients. In gastroenterology cannabis has been~     used to treat symptoms and diseases including anorexia, emesis, abdominal pain,~     gastroenteritis, diarrhoea, intestinal inflammation and diabetic gastroparesis.~      Cannabinoids have also a profound anti inflammatory effect, mainly through the CB2 receptor.~     Cell mediated immunity may be impaired in chronic marijuana users. And a potent~     anti-inflammatory effect of cannabis was observed in rats . Studying the functional roles of~     the endocannabinoid system in immune modulation reveals that there are no major immune events~     which do not involve the endocannabinoid system. Cannabinoids shift the balance of~     pro-inflammatory cytokines and anti-inflammatory cytokines towards the T-helper cell type 2~     profiles (Th2 phenotype), and suppress cell-mediated immunity whereas humoral immunity may be~     enhanced. They are therefore used for various inflammatory conditions including rheumatoid~     arthritis and asthma. In a mouse model of colitis cannabinoids were found to ameliorate~     inflammation and there are many anecdotal reports about the effect of cannabis in~     inflammatory bowel disease. However, there are no methodical reports of the effect of~     cannabis on inflammatory bowel disease. The aim of the proposed study is to examine in a~     double blind placebo controlled fashion the effect of smoking cannabis on disease activity in~     patients with IBD.~   "
192780|NCT01040897|"~     In 2003, Surgeon General Richard Carmona suggested that low health literacy is one of the~     largest contributors to our nation's epidemic of overweight and obesity. Over 26% of~     preschool children are now overweight or obese, and children who are overweight by age 24~     months are five times as likely as non-overweight children to become overweight adolescents.~     The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented~     intervention aimed at teaching pediatric resident physicians to promote healthy family~     lifestyles and prevent overweight among young children (age 0-2) and their families in~     under-resourced communities.~   "
192781|NCT01040884|"~     This will be a prospective, single-arm, single-center, open-label study to evaluate the~     preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients~     undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed~     by a trained physician. Subjects will be screened for inclusion in the study. Following~     signing of informed consent, screening procedures will be performed including demographic and~     medical history, vital signs, anthropometrics), chest radiography, if applicable and CT~     scanning, blood samples for coagulation indices (PT, APTT), if applicable, and pregnancy test~     in women of child-bearing potential.~      Within an 18-day screening period, eligible subjects will be enrolled into the study and~     undergo percutaneous aspiration or percutaneous biopsy or RF ablation utilizing the~     ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up~     for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect~     chest radiograph will be performed within 90 minutes of observation after chest aspiration if~     performed to detect the majority of post procedure pneumothoraces for biopsies in the chest.~     Post procedural CT will be performed according to the physician's consideration. ** Note **~     If any complications are observed while using the ActiSight System, the investigator will~     revert to using standard procedure.~   "
192782|NCT01040871|"~     This is a randomized, open-label, active-control, parallel-group, multicenter, multinational~     Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide,~     Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin,~     Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center~     B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)~   "
192783|NCT01040858|"~     The number of OEF/OIF veterans seeking care and rehabilitation services within the VA Health~     Care System is increasing rapidly. The cognitive effects of MTBI are clinically significant~     and can adversely affect a veteran's ability to reintegrate into civilian life, return to~     duty, succeed in competitive employment, or function independently. The primary product of~     the proposed study would be an empirically validated, manualized, cognitive rehabilitation~     intervention for OIF/OIF veterans with cognitive disorders. The group treatment modality has~     the virtue of efficiency and a manualized treatment approach would allow wide-ranging~     application throughout the VHA system. As such, the proposed study is likely to have a~     significant effect on the quality and effectiveness of rehabilitative services being offered~     to our returning soldiers with combat-related MTBI and cognitive impairment.~   "
192784|NCT01040845|"~     This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at~     steady state on the steady state pharmacokinetic profile of ethinyl estradiol and~     norethindrone (Ortho-Novum 1/35). It will also evaluate the effects, if any, of steady state~     ethinyl estradiol and norethindrone on colchicine at steady state. Finally, this study will~     assess the safety and tolerability of concurrent use of colchicine and an~     estrogen/progesterone-containing oral contraceptive.~   "
192785|NCT01040832|"~     The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is~     more efficient than cetuximab alone to control the cancer.~      EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate~     oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9).~      EMD 1201081 has been studied in six clinical trials in over 170 subjects either as a~     monotherapy or in combination with chemotherapeutic agents or targeted therapies. Two studies~     have been conducted in healthy volunteers. In the other five studies, subjects with advanced~     solid tumors, renal cell carcinoma, non-small cell lung cancer and colorectal cancer have~     been treated with EMD 1201081. Two studies are still ongoing. Future clinical development of~     EMD 1201081 will focus on colorectal cancer (CRC) and squamous cell cancer of the head and~     neck (SCCHN).~      In this Phase 2 study, subjects with recurrent or metastatic squamous cell cancer of the head~     and neck (R/M SCCHN), will be treated with cetuximab plus EMD 1201081 or cetuximab alone. The~     study will be conducted as a multicenter study in several European Union (EU) member states~     and the Unites States.~      EMD 1201081 in combination with cetuximab will be evaluated for antitumor activity in~     subjects by examining its effects on accepted clinical endpoints. Progression-free survival~     (PFS) will be evaluated in subjects treated with EMD 1201081 plus cetuximab compared to~     cetuximab alone in cetuximab-naïve subjects with R/M SCCHN who have progressed on a cytotoxic~     therapy.~      Cetuximab, approved in colorectal cancer and SCCHN in combination with platinum-based~     chemotherapy and SCCHN in combination with radiotherapy in the EU, will be provided as~     investigational medicinal product (IMP) in this study. Commercially available Cetuximab will~     be provided in the United States.~   "
192800|NCT01040637|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).~   "
192801|NCT01040624|"~     The purpose of this study is to see what effects, good and/or bad, proton based radiation~     combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.~   "
192814|NCT01040455|"~     Pharmacotherapy for functional dyspepsia remains unsatisfactory. Previous randomized trials~     reported conflicting results on clinical effectiveness of proton pump inhibitor in patients~     with functional dyspepsia. This study aims to examine whether lansoprazole 15mg is more~     effective than placebo for functional dyspepsia in Taiwanese patients, and to investigate the~     association between subgroups of patients and therapeutic response.~   "
192786|NCT01040819|"~     Type-2 diabetes mellitus is a public health concern. Patients with type 2 diabetes mellitus~     are at high risk of developing cardiovascular complications. Diabetic patients are two to~     four-times more likely to develope cardiovascular disease. The mortality of diabetic patients~     with cardiovascular disease is much higher than in non-diabetic matched patients with~     cardiovascular disease. Recently, it has become apparent that not all anti-diabetic drugs~     have the same effect on the progression of atherosclerosis and on cardiovascular outcomes.~     There is a great need to understand the potential protective mechanisms of the various~     anti-diabetic drugs in order to decrease their risk for cardiovascular morbidity and~     mortality. In addition to increasing insulin sensitivity, Pioglitazone (PIO) has~     anti-inflammatory properties. However, the underlying mechanisms of these anti-inflammatory~     (and probably anti-atherosclerotic) effects of PIO are unknown. We have shown in the rat that~     3-day pretreatment with PIO increases myocardial cyclooxygenase-2 (COX2) activity and levels~     of both 6-keto-PGF1a, the stable metabolite of prostacyclin (PGI2) and 15-epi-lipoxin A4, a~     lipid mediator with a strong anti-inflammatory properties. Prostacyclin inhibits platelet~     aggregation and causes vasodilatation. Increased levels of 6-keto-PGF1a and 15-epi-lipoxin A4~     may thus be the explanation for the anti-inflammatory and anti-atherosclerosis effects of~     PIO. Several clinical studies have shown that COX2 inhibition is associated with increased~     cardiovascular events. Thus, augmenting COX2 activity and the production of prostacyclin and~     15-epi-lipoxin A4 may have potential favorable effects. The purpose of the study is to test~     whether PIO therapy is associated with an increase in serum and/or urine levels of~     6-keto-PGF1a and 15-epi-lipoxin A4 in patients with diabetes mellitus type 2.~   "
192787|NCT01040806|"~     Patients with diabetes who are counseled by a peer coach (another patient with diabetes) will~     have improved glycemic control compared with usual care patients.~   "
192788|NCT01040793|"~     To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of~     treatment in patients with Chronic Obstructive Pulmonary Disease.~   "
192789|NCT01040780|"~     The purpose of this study is to determine whether Icotinib is at least non-inferior to~     Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one~     or two chemotherapies.~   "
192790|NCT01040767|"~     Study Objective: Training physicians in new skills via classroom-based teaching has inherent~     costs and time constraints. We sought to evaluate whether web-based didactics result in~     similar knowledge improvement and retention of basic ultrasound principles and the EFAST~     (Extended Focused Assessment with Sonography for Trauma) compared with the traditional~     method.~      Methods: Physicians from two German emergency departments were randomized into a classroom~     group with traditional lectures and a web group that watched narrated lectures online. All~     participants completed a pre- and post-test, and a second post-test eight weeks later. Both~     groups underwent hands-on training after the first post-test. A control group completed the~     two initial tests without didactic intervention.~   "
192791|NCT01040754|"~     The results of the proposed experiments will directly inform clinicians who treat patients~     with osteoarthritis of the knee about how to maximize the benefits of acupuncture treatments.~     And because the experiments specifically asks the question of what is the relation between a~     patient's expectation of how a treatment will relieve their pain and the outcome of the~     treatment, the results will potentially inform care givers about all treatments for~     osteoarthritis and other chronic pain disorders. We hypothesize that acupuncture treatment~     will produce clinically significant analgesia as indicated by lowered sensory ratings of~     noxious stimuli and endogenous knee pain.~   "
192792|NCT01040741|"~     This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted~     Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive~     either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either~     1 or 2 doses.~   "
192793|NCT01040728|"~     The study is intended to characterize the lung function profile of BI1744 in Chronic~     Obstructive Pulmonary Disease (COPD) patients where patients will perform pulmonary function~     tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient~     will receive all four treatments.~   "
192794|NCT01040715|"~     The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid~     (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously~     treated with anti-TNFα mAb but have lost susceptibility to therapy.~   "
192795|NCT01040702|"~     The aim of the study is to assess the effect of Methylphenidate on cognitive performance and~     decision-making ability of ADHD adults, and to compare this effect to the effect on healthy~     control adults.~   "
192796|NCT01040689|"~     The study is intended to characterize the lung function profile of BI1744 in COPD patients~     where patients will perform pulmonary function tests at regular intervals for 24 hours at the~     end of a 6 week treatment period. Each patient will receive all four treatments.~   "
192797|NCT01040676|"~     The Automated Telephone Nutrition Support (ATNS) study investigates the effect of automated~     telephone nutrition support on diet and glycemic control among Spanish-speaking diabetics in~     Oakland.~   "
192798|NCT01040663|"~     In recent decades, the prevalence of obesity has increased dramatically in the United States.~     Obesity has been associated with an increased risk of the metabolic syndrome, which is~     characterized by a cluster of metabolic derangements, including insulin resistance, high~     blood sugar, high triglycerides, low high density lipoprotein (HDL) cholesterol levels, high~     blood pressure, and inflammation. Lifestyle interventions, including dietary modification,~     physical activity, and weight loss, form the basis of treatment for individuals with the~     metabolic syndrome. However, the optimal composition of the diet is not known at this time.~     Furthermore, due to hormonal and metabolic changes that accompany weight loss, most people~     find it very difficult to maintain significant weight reductions over time. As a result,~     weight regain is exceedingly common.~   "
192799|NCT01040650|"~     Statins are a class of drugs given to lower cholesterol. Although statins are considered to~     be generally safe, some studies show that about 10% of people on statins develop~     muscle-related symptoms, from fatigue (tiredness), weakness, cramping, pain and sometimes a~     lifethreatening muscle breakdown condition known as rhabdomyolysis. In some, these symptoms~     may greatly affect their daily activities. One consideration why symptoms develop in only~     some patients is that they may have an underlying problem in the way their muscles use fats~     to produce energy. In these patients, the muscles are not able to fully utilize fats and so~     they become tired more easily. Fat within the muscle can also affect how your body uses a~     hormone called insulin, which affects your blood sugar levels. The investigators are~     specifically interested in previous statin users and determine if the muscle symptoms are~     related to changes in energy and sugar use. We propose to enroll patients who have developed~     muscle side effects on previous statin treatment and have since discontinued statin~     treatment.~      Our aim is to compare the metabolic parameters in these patients to age and gender-matched~     normal individuals.~   "
192802|NCT01040611|"~     Tuberculosis belongs to chronic diseases as a result of the treatment of disease over a long~     period, admission to negative pressure isolation wards, and restrictions on visitors. During~     the in-patient admission, patients are vulnerable to social isolation and separation anxiety.~     If anxiety sustained, patients' quality of life would be affected. Thus, it is important to~     improve patients' experience of anxiety. Music has the effectiveness of relaxation, and is~     helpful to patients' anxious status and physiological responses. This study examined the~     effectiveness of music therapy on anxiety, depression and physiological responses for~     patients with tuberculosis.~   "
192803|NCT01040598|"~     Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea,~     epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal~     symptoms along with obstructive esophageal symptoms in both pediatric and adult population.~     The pathology of this disease is postulated to be allergy mediated and the incidence of this~     disease is seen to parallel an increase in the incidence of allergies and asthma.~      Most of the current therapies for EoE are directed at decreasing esophageal allergic~     inflammation and mirror the treatment options for allergic asthma. Swallowed corticosteroids~     and elimination diets or elemental diets have shown variable efficacy is improving symptoms.~     However, specific pathophysiologic mechanism of EoE is still largely unknown and there is no~     definitive treatment that completely resolves symptoms and histological findings. Omalizumab~     is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled~     and oral corticosteroids and improve asthma related symptoms in patients with allergic~     asthma. In this study, Eosinophilic esophagitis is being used as a disease model to study the~     mechanism of action of monoclonal Anti-IgE antibody in vivo. The resolution of symptoms~     clinically, and histological changes (and improvements) in response to treatment with Xolair~     (omalizumab) in patients suffering from EoE will be determined. The primary objective of this~     open label, study is to determine mucosal markers that will predict responders to Omalizumab~     (Xolair).~   "
192804|NCT01040585|"~     The therapy with Linezolid (LIN) represents better cost-effectiveness vs. Vancomycin (VAN)~     for the treatment of nosocomial Pneumonia associate to ventilator (VAP).~   "
192805|NCT01040572|"~     The main aim of this study is to analyze and report traditional, patient-centered, and~     composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass~     surgery for weight recidivism.~   "
192806|NCT01040559|"~     The purpose of this study is to determine the maximal tolerated dose of idarubicin for~     chemoembolization of non resectable non metastatic hepatocellular carcinoma.~   "
192807|NCT01040546|"~     The purpose of this study is to assess study subjects' adherence to different weight control~     intervention programs and the effect of intervention programs on physical and biochemical~     examinations, physical fitness, food intake and exercise behaviors and the prevalence of~     metabolic syndrome and its components' abnormalities.~   "
192808|NCT01040533|"~     This study objectives are the following.~        -  To describe the updated clinical presentation, indications, and multidisciplinary~          medical management of patients with a failed and/or complicated jejunoileal bypass~          (JIB).~        -  To analyze the feasibility, safety, and efficacy of one-stage laparoscopic re-operative~          gastric bypass surgery for failed and/or complicated Jejunoileal bypass (JIB) for weight~          loss.~        -  To determine what factors or strategies are associated with a successful outcome. In~          particular, the completion of the surgery in one stage with a laparoscopic approach.~   "
192809|NCT01040520|"~     The aim of the study is to compare findings generated by CT-based autopsy (Virtopsy) with~     conventional autopsy and clinical diagnoses. Therefore all patients dying while receiving~     treatment in the Department of Intensive Care Medicine will be undergo virtopsy and, if~     relatives give informed consent conventional autopsy.~   "
192810|NCT01040507|"~     The main aim of this study is to analyze and report the very long-term outcomes after primary~     laparoscopic proximal Roux-en-Y gastric bypass surgery for clinically severe obesity.~   "
192811|NCT01040494|"~     Aliskiren is a potent direct renin inhibitor and has been recently shown to have favorable~     neurohumoral effects in patients with heart failure (HF) Objective：To study the effects of~     add-on aliskiren treatment in patients with HF on components of arterial load, from central~     aorta to peripheral arterioles and biomarkers Methods：Patients with NYHA Class II to IV HF,~     who have been treated with angiotensin-converting enzyme inhibitor (ACEI) or angiotensin~     receptor blocker (ARB) and beta-blocker are randomized to 6 months of treatment with placebo~     or aliskiren (150mg per day) treatment. Components of arterial load, from central aorta to~     peripheral arterioles as well as a wide-range of biomarkers, including inflammatory~     biomarkers, N-terminal pro-B type natriuretic peptide, arterial remodeling markers~     (procollagen, matrix metalloproteinase) will be measured before, 2 months and 6 months after~     treatment.~      What is New or Innovative in this study? The importance of central hemodynamics and biomarker~     changes in patients with HF has been shown in observation studies. This is the first~     randomized control trial that examines comprehensively the effects of a direct rennin~     inhibitor on central hemodynamics and biomarkers in HF patients who are receiving standard~     heart failure therapy.~   "
192812|NCT01040481|"~     The main aim of this study is to analyze and report the preliminary and intermediate term~     outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism.~     The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and~     expressed as trends in BMI, %EWL, and/or %EBL; 2) Trend in Comorbidity status; and 3) Patient~     satisfaction and Health-Related Quality of Life HR-QoL measured by a standardized,~     non-validated subjective satisfaction questionnaire and the validated, disease-specific,~     Moorehead-Ardelt II QoL questionnaires, respectively; 4) Morbidity & Mortality including~     nutritional status and metabolic complications.~      Consequently, secondary objectives of this study are 1) to assess failure rate defined as~     percentage of excess weight loss < 50% , lowest BMI >35 for morbidly obese (MO) or >40 for~     superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point in~     time when assessing preliminary and intermediate results after the surgery under analysis. 2)~     To evaluate the metabolic and nutritional status by measurements of particular clinical and~     biochemical parameters.~      This research is in line with the most current provocative new ideas and recent high impact~     publications. To the best of our knowledge, this is the very first outcome study of~     revisional malabsorptive distal gastric bypass surgery by laparoscopy with diverse revisional~     strategies such as revisional gastroplasty, revisional Fobi-Capella, revisional Adjustable~     Gastric Band, conversion to distal, and conversion to very, very long limb gastric bypass.~     Previously, several studies have addressed conversion to malabsorptive gastric bypass after a~     failed primary proximal gastric bypass but none has addressed the failed distal gastric~     bypass nor the adequate balance between increasing restriction and malabsorption for~     decreasing the risk of protein-calorie malnutrition.~   "
192817|NCT01040416|"~     The objective of this study is to identify the incidence rate; describe the risk factors,~     clinical presentation, and endoscopic treatment; assess the morbidity, mortality, and overall~     performance of the management of patients with actively bleeding marginal ulcers after~     Roux-en-Y gastric bypass (RYGB) surgery.~   "
192818|NCT01040403|"~     The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL~     and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week~     treatment in patients with COPD.~   "
192819|NCT01040390|"~     Acne is one of the most common skin problems in teenagers and adolescents. There are many~     lesser known homoeopathic medicines which have been mentioned in the literature for treatment~     of acne but their potential has not been properly assessed /documented and therefore these~     medicines don't form a part of many prescriptions. As a part of this study,efficacy of Lappa~     Arctium will be studied in the treatment of Acne vulgaris~   "
192820|NCT01040377|"~     The main aim of this study is to analyze and report traditional, patient-centered, and~     composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass~     surgery for inadequate initial weight loss.~   "
192821|NCT01040364|"~     The main goal of this study is to describe the trends in the incidence rate of internal~     hernia presentation after different modifications of the mesenteric closure technique after~     primary laparoscopic Roux-en-Y gastric bypass (RYGB) surgery from 1997-2009.~   "
192822|NCT01040351|"~     The aim of this study is to determine whether the ultrasound guided aspiration of~     hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .~   "
192823|NCT01040338|"~     A substantial body of evidence implicates the endogenous opioid system, and the mu opioid~     receptor (MOR) in particular, in the reinforcing effects of drugs of abuse, including~     nicotine. A single nucleotide polymorphism (SNP) in the mu opioid receptor gene (OPRM1 Asp40)~     is associated with the ability to quit smoking, as well as nicotine reward and withdrawal~     symptoms. However, the precise mechanism through which this SNP influences nicotine~     dependence remains unresolved. This positron emission tomography (PET) study will examine~     whether this OPRM1 SNP alters MOR binding in response to nicotine in human smokers.~     Specifically, we will use [11 C]carfentanil PET imaging to assess the effects of intravenous~     (IV) nicotine versus saline (within-subject) on MOR binding potential in 24 chronic smokers~     genotyped prospectively and stratified by OPRM1 genotype.~   "
192824|NCT01040325|"~     The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent~     moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.~   "
192825|NCT01040312|"~     The purpose of this study is to examine the correlation between UGT1A1 genotypes and the~     safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for~     patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.~   "
192826|NCT01040299|"~     Transcranial galvanic stimulation (tDCS), seems to promote motor recovery after stroke by~     stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment~     of severe lower limb paresis after stroke, the GangTrainer GT1 (GT) proved to be effective,~     but nevertheless only a few patients could use their affect lower limb functionally in daily~     life on deambulation after robot training. Therefore the present study intends to combine~     both approaches, tDCS + GT, apply at the same time every day for two weeks in order to~     improve the effectiveness of GangTrainer therapy in the gait rehabilitation.~   "
192827|NCT01040286|"~     The purpose of the study is to assess efficacy and safety of Flurbiprofen Chip versus~     Chlorhexidine chip (Periochip®) in therapy of adult chronic periodontitis.~   "
192828|NCT01040273|"~     Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage~     following major orthopedic surgery often involves a large, deep incision with considerable~     tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such~     surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay~     mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical~     costs.~      We design a prospective randomized study for postoperative pain control following total hip~     arthroplasty.~   "
192829|NCT01040260|"~     An innovative low-cost form of contingency management has been developed in which~     participants receive the chance to draw vouchers from a fish bowl depending on whether or not~     their abstinence from tobacco is confirmed by expired-air carbon monoxide. The vouchers can~     be redeemed for prizes of varying value. This form of contingency management has been shown~     to be effective in the treatment of a variety of substance use disorders, but has not been~     investigated in a clinical trial focusing on smoking cessation. Thus, the primary purpose of~     the proposed study will be to investigate the effects of a low-cost prize-based form of~     contingency management in the treatment of nicotine dependence. To accomplish this objective,~     we enrolled 103 current smokers into the study. The participants in Study Arm 1 received the~     contingency management intervention for 8 weeks, and the participants in Study Arm 2 had~     their smoking status assessed but did not receive the contingency management intervention.~     Both interventions received brief counseling and nicotine replacement therapy. The counseling~     was conducted in two 60-minute individual sessions scheduled one week apart with two~     follow-up phone calls at weeks 3, 4, and 6.~      The primary outcome for this study was biochemically-validated smoking status at 3 months~     (end of treatment), and at 6- and 12-month follow-up. Both continuous and point-prevalent~     abstinence rates were determined. Saliva cotinine levels were measured in all participants~     reporting abstinence at each assessment. This study had 80% power to detect a 10% absolute~     difference in smoking cessation rates between the two treatment conditions (i.e., a 28% quit~     rate in Study Arm 1 versus a 18% quit rate in Study Arm 2) with alpha set at 0.05. These~     estimates included an anticipated 15% loss to follow-up over the 12-month study period.~   "
192830|NCT01040247|"~     Women undergoing in vitro fertilization (IVF) therapy, who are low responder and agree to~     enter the trial will be randomized to a study group, for whom embryo transfer will be done on~     the same day as oocyte aspiration and fertilization; and a control group for whom embryo~     transfer will be performed 48 to 72 hours later, as is the current accepted practice.~   "
192831|NCT01040234|"~     A prospective study of 30 patients with severe postoperative pain following abdominal~     surgery, in which the dual TAP block technique has been used successfully to achieve pain~     relief. A description of ultrasound technique, effectiveness, duration and potential side~     effects of the pain treatment, with possible recommendations for future use.~   "
192834|NCT01040195|"~     Till now no drug has been conclusively shown to affect the natural course of the inflammatory~     back ache in seronegative spondylarthropathies. Non-steroidal anti-inflammatory drugs~     (NSAIDS) have been the main stay of treatment for these diseases for long. Despite providing~     good pain relief, they are largely ineffective in altering the natural course of these~     diseases. However, very often, in spite of therapy, pain and discomfort continues in these~     patients with recurrent exacerbations. Other drugs have been tried in these patients.~      The DMARDS (Disease Modifying Anti Rheumatic Drugs) are a group of drugs which have come into~     prominence following their remarkable efficacy in the management of Rheumatoid Arthritis,~     another chronic inflammatory autoimmune arthritis. The major drugs which come in this group~     are Methotrexate, Sulfasalazine, Hydroxychloroquine and Leflunomide. Of these drugs, the most~     well studied drug in Spondylarthropathy is Sulfasalazine. Trials have shown variable results~     of response of spondyloarthropathy to sulfasalazine. The other major DMARD tried is~     methotrexate. Though large well controlled trials are lacking, the available data on its~     efficacy in spondyloarthropathy has not been favorable. Leflunomide, the other major DMARD~     has also fared poorly in a controlled trial in ankylosing spondylitis. There is at present~     inadequate data regarding the efficacy of Hydroxychloroquine.~      The discovery of anti TNF-α have been the major breakthrough in the management of ankylosing~     spondylitis (AS) and Spondyloarthropathies (SpA). These drugs, besides providing symptomatic~     improvement, also produce improvement in the indices of disease activity as Bath Ankylosing~     Spondylitis Disease Activity Index (BASDAI) and the Assessment of Spondylo-Arthritis~     International Society (ASAS). Besides, the enormous cost, incurred at a rate of about Rs~     700,000/- per annum, put it out of reach of the majority of affected population. Add to these~     is the increased risk of tuberculosis and fungal infections, a major problem in India.~      In this background there is severe and pressing need for alternate safe and effective drugs~     in the management of these diseases. It is here that the combination DMARD therapy assumes~     importance as a potential safe and cheaper alternative.~      We aim to assess the efficacy of combination DMARD therapy in patients with early~     inflammatory chronic backache in patients with sero negative spondyloarthropathies.~   "
192835|NCT01040182|"~     The purpose of this study is to explore the association between the genetic polymorphisms of~     estrogen-related genes, including estrogen synthesis, metabolizing, and receptor genes, and~     ischemic stroke. Furthermore, independent and joint effects of traditional risk factors and~     estrogen related genes on risk of stroke in young adults will also be examined in this study.~   "
192836|NCT01040169|"~     Tooth sensitivity reduction after dentifrices use~   "
192837|NCT01040156|"~     Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone~     marrow transplantation. In the present retrospective analysis we assess the safety and~     efficacy of different regimens in antimycotic prophylaxis.~   "
192838|NCT01040143|"~     A study taking swabs from the back of the nose (nasopharynx) to look at carriage of~     pneumococci.~   "
192839|NCT01040130|"~     To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of~     treatment in patients with Chronic Obstructive Pulmonary Disease~   "
192840|NCT01040117|"~     Balance impairment is a common and very disabling disturbance in people with Multiple~     Sclerosis. The efficacy of pharmacotherapy in treating balance impairment in MS is poorly~     documented in literature. Although literature dealing with the rehabilitation of balance~     impairment in MS is very scant, the preliminary data reports show very promising results. The~     present project could have a positive impact on balance and gait ability, disability, fear of~     falling, risk of falls and quality of life of patients with Multiple Sclerosis.~   "
192841|NCT01040104|"~     Regular wound healing follows a well-ordered sequence of overlapping phases: inflammation,~     proliferation, maturation and remodelling.~      In the young, damage to an organ mostly triggers fully regenerative mechanisms called~     primary wound healing. Repeated damage in young individuals may cause secondary wound~     healing eg. scar formation reflecting a rescue program, in which reorganisation has failed.~      Organ failure in the ageing organism is characterized by a progressive loss of its capability~     to achieve an orderly reactivation of organ repair, and results in a combination of chronic~     inflammation and fibroproliferative, non-regenerative repair affecting several organs,~     including lung, liver and skin.~      RESOLVE's objective is to identify, characterize, and validate molecular targets responsible~     for shifting primary organ repair towards fibroproliferative wound healing as a result of an~     age-dependent loss of regulatory control.~      The structured approach is based on~        -  different forms of wound healing,~        -  different human diseases and~        -  different genetic backgrounds,~      aiming to provide future diagnostic tools in various organs, to create transgenic animal test~     systems, and to identify molecular targets involved in fibroproliferative wound healing.~   "
192842|NCT01040091|"~     Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are two antiretroviral~     medications used for the treatment and prevention of HIV/AIDS. This study will examine how~     these medications are processed in the body of people who are HIV-infected, as well as in~     people who are HIV-uninfected.~   "
192843|NCT01040078|"~     The purpose of this study is to generate data on immunogenicity and safety of the monovalent~     H1N1 vaccine in support of the development and registration.~   "
192844|NCT01040065|"~     The purpose of this study is to determine whether distal clavicle resection is effective~     treatments in patients with acromioclavicular joint pain accompanied by rotator cuff tear.~   "
192845|NCT01040052|"~     The objective of this study is to describe the safety of Adacel® vaccination in adults~     subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in~     support to Adacel® registration.~      Primary objective:~      To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after~     immunization.~   "
192846|NCT01040039|"~     This pilot study aims to study gut B cells in HCV+HIV+, HCV+HIV-, HCV-HIV+, and HCV-HIV-~     volunteers. Volunteers will undergo a screening blood draw and flexible sigmoidoscopy with~     biopsy.~   "
192873|NCT01039688|"~     This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to~     methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This~     study will also compare the safety of CP-690,550 with methotrexate.~   "
192874|NCT01039675|"~     The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the~     combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.~   "
192875|NCT01039662|"~     This study aims to investigate the effect of supplement containing L-arabinose and~     indigestible dextrin on dietary glycemic index.~   "
192876|NCT01039649|"~     It is known that radiation damages lung tissue. New human studies at University of Iowa show~     that the radiation damage is not as expected. The purpose of this study is to document lung~     function using four-dimensional computed tomography (CT) and quantify changes three months~     after radiation therapy for malignant lung disease.~   "
193059|NCT01037205|"~     This protocol will seek to enroll adult otherwise healthy subjects presenting with~     influenza-like illness (ILI). Subjects will enter the study based on listed~     inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).~   "
192847|NCT01040026|"~     High-dose chemotherapy with melphalan and autologous hematopoietic stem cell transplantation~     (HSCT) is considered standard treatment for patients with multiple myeloma. While autologous~     HSCT may induce remission in patients resistant to standard chemotherapy, and has been shown~     to lead to long-lasting disease control in a subgroup of patients, the procedure is not~     curative. Given enough time and in the absence of a competing cause of death, all patients~     eventually relapse after auto-HSCT.~      The only potentially curative approach currently available in the treatment of multiple~     myeloma (MM) is stem cell trans-plantation from an allogeneic donor. Allogeneic HSCT~     eradicates residual myeloma cells through T-cell mediated graft-versus-tumor effects.~     Allogeneic HSCT is, however, associated with significant risk of graft-versus-host disease~     and its use is therefore limited to younger patients with high risk dis-ease. Malignant~     plasma cells in multiple myeloma are also sensitive to natural killer cell lysis. Natural~     killer cells do not cause graft-versus-host disease, which has led to interest in their~     therapeutic use in patients with multiple myeloma.~      We have previously shown that immunomagnetic separation of a highly pure NK cell product from~     a leukapheresis is possible and that these cells can be expanded up to 100-fold in a~     GMP-compatible setting. The current study aims to test the tolerability and feasibility of~     infusions of in vitro expanded haploidentical NK cells for patients after melphalan 200mg/m2~     high dose chemotherapy and autologous HSCT in 10 patients. If feasible, the data will provide~     a basis for further prospective studies.~   "
192848|NCT01040013|"~     Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation.~     during surgery and for 6 days after operation, intestinal oxygen tension and~     ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is~     associated with reduced splanchnic blood flow and ischemia-reperfusion injury.~   "
192849|NCT01040000|"~     The purpose of the phase 2 component of this study is to determine if giving the immune~     molecule NPC-1C to individuals who have cancer of the pancreas or gastrointestinal tract~     (colon or rectum) which has not responded to standard treatments can shrink or halt the~     growth of cancer, and to obtain additional data to study its effect on the immune system.~     Safety data will also be accumulated and evaluated during this study. NPC-1C is a monoclonal~     antibody that recognizes a specific tumor target on certain cancers. In laboratory studies,~     the antibody killed tumor cells in some colon and pancreatic cancers that express the NPC-1C~     antigen by a process called antibody-dependent cell cytotoxicity or ADCC.~   "
192850|NCT01039987|"~     The Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of~     Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a~     consortium of participating clinical centers (PCCs) and a data coordinating and imaging~     analysis center (DCIAC) to develop and implement studies to test whether imaging techniques~     can provide accurate and reproducible markers of progression of renal disease in patients~     with polycystic kidney disease.~      The awarded participating clinical centers are Emory University, University of Kansas, and~     Mayo Foundation (with a subcontract to the University of Alabama). The awarded DCIAC is~     Washington University in St. Louis. Due to the relocation of the DCIAC P.I. from Washington~     University to the University of Pittsburgh, the DCIAC for CRISP II is located at the~     University of Pittsburgh.~   "
192851|NCT01039974|"~     This study will determine the effect of 400 mg ketoconazole on the pharmacokinetics of a~     single dose of GSK962040. The results from this study will help to estimate the maximum~     increase in exposure during concomitant use of strong CYP3A4 inhibitors. This study will also~     contain an exploratory investigation of biliary secretion of GSK962040 and or its~     metabolites.~   "
192852|NCT01039961|"~     The purpose of this study is to evaluate the safety of an IV infusion of GW856553 in healthy~     volunteers.~   "
192853|NCT01039948|"~     During Phase 1b portion, there will be a dose-escalation of AV-299 (formerly SCH 900105) in~     combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid~     tumor. The objective is to determine the safety, tolerability, dose limiting toxicity (DLT)~     and recommended Phase 2 dose (RP2D) in combination with gefitinib for the Phase 2 portion.~      The Phase 2 is an open-label, 2-arm, randomized study designed to compare the combination of~     AV-299 (formerly SCH900105) and gefitinib versus gefitinib alone in clinically selected Asian~     subjects with previously untreated lung adenocarcinoma who have a high likelihood of~     harboring activating EGFR mutations. Subjects who progress after initial disease control in~     the gefitinib alone arm may crossover to the combination arm.~   "
192854|NCT01039935|"~     Prior to the main study we will perform a pilot study on 60 subjects. The purpose of the~     pilot study is to identify the range of odor concentrations that will be used in the main~     study and to optimize the tasks performed in the main study.~   "
192855|NCT01039922|"~     Gastroentero-pancreatic neuroendocrine tumours (GEP-NETs) are regarded as a fairly rare~     disease. They are derived from the neuroendocrine system of the gastrointestinal tract and~     the pancreas and share common clinical features. So far, there is still uncertainty about the~     cell biology and mechanistic regulation of these tumours. Therefore targeted treatment is~     limited and management challenging. Treatment options include surgery, medical and ablative~     therapy, and more recently peptide-receptor radionuclide therapy. In order to better~     understand the characteristics of GEP-NETs and to evaluate treatment strategies, the SwissNET~     registry aims at the collection of data from patients presenting with a GEP-NET in~     Switzerland. Data will be entered prospectively and anonymized in a specifically designed~     database after the patient has given informed consent. All hospitals and general~     practitioners are invited to report on patients with a GEP-NET diagnosis and to participate~     to the registry. Data will be evaluated within regular time frames, focussing on types of~     GEP-NETs, treatment modalities and patient outcomes (e.g. mortality, hospitalisation rate),~     thereby contributing to the better understanding of these tumours.~   "
192888|NCT01039493|"~     The objective of this study is to establish patient preferences in regards to common~     complications of cervical cancer treatments, and to compare these preferences to those of~     medical providers who care for cervical cancer patients. These preferences will be determined~     via a interview using the Standard Gamble, which is a well-recognized method for establishing~     utilities.~   "
193060|NCT01037192|"~     Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h)~     administration provides non-inferior clinical efficacy and microbiological efficacy to~     standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in~     an outpatient setting.~   "
192856|NCT01039909|"~     The main purpose of this study is to investigate the effect of SRT2104 upon energy production~     in muscle (specifically the maximum amount of energy produced with muscle contraction), how~     much sugar and fat are stored in the muscle, and the size of the muscle after receiving 2.0 g~     of SRT2104 or placebo given in capsule form once a day for 28 days including a 14 day knee~     and lower leg immobilisation period during the final 14 days of dosing.~      Imaging methods, muscle biopsies and exercise tests will be used in the study to see whether~     the following measurements change after taking SRT2104 for 28 days, including an immobilised~     knee and lower leg for the final 14 days of dosing.~      i) energy reaching the muscles ii) muscle strength iii) changes in the structure of the~     muscle~      This study will also investigate the pharmacokinetics, safety and tolerability of 2.0 g of~     SRT2104 administered orally once daily for 28 consecutive days. The investigation of~     pharmacokinetics of SRT2104 allows us to gather information regarding:~      i) how long it takes for the drug to be absorbed and detected in the blood ii) how much we~     can detect iii) how long we can detect it for iv) how often we need to give the drug to~     maintain a steady amount in the blood.~      SRT2104 will be given to healthy subjects aged between 18 and 40 years old. Subjects will~     participate in this single centre study for approximately 79 days. The study consists of 11~     outpatient clinic visits and 4 telephone calls (including a prescreen call to determine~     whether subjects are interested in participating).~   "
192857|NCT01039896|"~     The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.~   "
192858|NCT01039883|"~     The purpose of this study is to determine whether albaconazole tablets and albaconazole~     capsules (single 400mg dose) act in the body in the same way over a period of time.~   "
192859|NCT01039870|"~     This study aims to evaluate the effect of the paravertebral block using a multi-lumen~     catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to~     the thoracic epidural block.~   "
192860|NCT01039857|"~     This is an intervention study with patients after a non-progressive brain injury who suffer~     from depression. It will determine whether an integration of neuropsychological and~     psychotherapeutic techniques and an additional caregivers support program offers benefits to~     those in the process of coping with the effects of a stroke. The investigators expect the~     integrative neuro-psychotherapy to be more effective in the treatment of emotional distress~     reactions following a stroke than the structured solution focused treatment.~   "
192861|NCT01039844|"~     The goal of this clinical research study is to find the highest tolerable dose of~     LOC-paclitaxel when given to patients with metastatic melanoma. The safety of this drug and~     if it can control the disease is also being studied.~   "
192862|NCT01039831|"~     The relationship between WM lesions (WM) and Postural Instability Gait Disorders (PIGD-PD)in~     Parkinson's disease patients is largely unknown. We hypothesize that sub-clinical WM~     pathology may be a major contributing factor to PIGD-PD. We will compare two groups of~     patients with Parkinson's disease (PD): those with PIGD and patients with dominant tremor~     (n=120)to assess the role of brain WM changes.~   "
192863|NCT01039818|"~     The purpose of this study is to determine whether higher doses of radioiodine increase~     treatment efficacy in severe Graves' disease.~   "
192864|NCT01039805|"~     The aims of MOT112571 are to assess the pharmacodynamic effects, safety, tolerability,~     pharmacokinetics, and potential therapeutic benefit of single doses of GSK962040 in~     critically ill patients with delayed gastric emptying and who are intolerant to enteral~     feeding.~   "
192865|NCT01039792|"~     The purpose of this study is to determine whether the supplement Methyl B12 is effective in~     treating some of the symptoms of Autism.~   "
192866|NCT01039779|"~     The effects of tai chi exercise and lower-extremity training on improving the primary outcome~     and secondary outcomes among older people will be compared.~   "
192867|NCT01039766|"~     This study is designed to test the hypothesis that a single administration of intranasal~     oxytocin within 6 hours post-trauma facilitates the physiological recovery for the trauma,~     thereby preventing the development of Post Traumatic Stress Disorder (PTSD) in the months~     following the event. In the absence of such treatment (i.e., under placebo conditions), we~     hypothesize that a greater proportion of persons will develop PTSD (i.e., fail to recover~     from acute effects).~   "
192868|NCT01039753|"~     Acute kidney injury is more frequent and the mortality rate would be as high as 50-60% when~     the renal replacement therapy was needed. Many studies about the timing of start and~     discontinuation of dialysis, dialysis dose, dialyzer, anticoagulation and dialysates were~     initiated but the results were still controversial. In addition, more new biomarkers were~     found to predict the outcome of acute kidney injury and these biomarkers may play an~     important role for the dilemma of aforementioned studies.~      This observational prospective study has two objectives:~        1. To find the predictors of outcome for the acute kidney injury with renal replacement~          therapy and determine the appropriate method.~        2. To find the relationship between new biomarkers and acute kidney injury and determine~          whether it can be a factor for the monitor of the response of the renal replacement~          therapy.~   "
192869|NCT01039740|"~     The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine~     responsiveness in advance before the appearance of the drug effect until 4-6 weeks after~     administration of Mirtazapine.~   "
192870|NCT01039727|"~     The first objective of this thesis is to investigate the hypothesis that prerecorded~     autosuggestion (PA) can be a theoretically valuable (efficacy) and practical (efficiency)~     tool in the care of many patients with chronic pain. With a prevalence in chronic pain~     conditions of +/- 20% of adults, chronic pain is a huge problem for individuals as well as~     for society, absorbing an enormous amount of resources. Even with all available treatments,~     many people still suffer from chronic pain, in particular when this pain has a psychosomatic~     ('functional') origin. In the PALPI study (Prerecorded Autosuggestion in Long-standing Pain~     Intervention), accompanying this thesis, efforts are made to mainly involve chronic pain of~     clearly psychosomatic origin.~   "
192871|NCT01039714|"~     Hypocalcemia is one of the most frequent complications of total thyroidectomy, a procedure~     used for benign as well as malignant conditions of the thyroid gland. Postoperative~     hypocalcemia is usually caused by hypoparathyroidism. Vitamin D is implicated in calcium~     metabolism as it increases intestinal calcium transport and regulates parathormone~     production. Aim of the present study is to evaluate preoperative vitamin D levels as a~     prognostic factor for postoperative hypocalcemia and hypoparathyroidism.~   "
192877|NCT01039636|"~     The purpose of this research study is to study the safety of increasing doses of FBS0701, and~     to see how quickly the study medication is absorbed and how quickly it disappears from the~     bloodstream. FBS0701 is a new, oral iron chelator - a medication taken by mouth that~     increases the body's elimination of iron. Iron chelators are used in patients who develop~     iron overload from their transfusions. Four increasing doses of FBS0701 will be tested during~     this study. The study will start with the lowest dose given to 4 patients (3 mg/kg/day. The~     next group of 4 patients will receive the next high dose (8mg/kg/day only after the results~     of the first 4 patients are examined and it is determined safe to continue. Participating~     patients will take the study medication for 7 days and be followed for 28 days after their~     last dose to determine if they have any reactions to the study medication - therefore a total~     of 35 days on study. Patients will need to give up to 17 blood samples over the screening~     period and first 15 days of the study (a total of about 9 tablespoons). Patients will not~     need to stay overnight in the clinic but will need to visit the clinic 10 times for screening~     and on-study visits over the 35 days. Patients currently taking an iron chelator will need to~     stop that treatment for up to 22 days (up to 5 days before they start the study and for 15~     days during the study). The results of this study will be helpful in determining the safety~     of the drug and the best doses of FBS0701 to be used in the next study which will assess the~     effectiveness of this new iron chelator.~   "
192878|NCT01039623|"~     Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive~     the adjuvant vaccine while the other group will get intradermal antigen, without the~     adjuvant. The antibody production will be compared.~   "
192879|NCT01039610|"~     GSK945237 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of~     antibiotics. GSK945237 has demonstrated in vitro and in vivo activity against Gram positive~     [including methicillin resistant Staphylococcus aureus (MRSA)] and Gram-negative pathogens~     associated with respiratory tract, skin and soft tissue infections including isolates~     resistant to existing classes of antimicrobials. This study will be conducted in four (4)~     parts, with a single oral dose being explored in Part A (2400 mg) and repeat oral doses~     (b.i.d. and q.d.) being explored in Part B. Parts C and D will be optional evaluations of~     repeat oral doses of linezolid and a comparative evaluation of the effect of GSK945237 and~     moxifloxacin, respectively. Parts A and B will be single-blind, randomized,~     placebo-controlled, dose-rising (Part B only) studies of healthy subjects to evaluate the~     safety, tolerability and pharmacokinetics of GSK945237. The proposed doses range from 400 mg~     to 2400 mg. Part C will be a single-blind, randomized, and placebo-controlled repeat dose~     evaluation of 600 mg (b.i.d.) of linezolid. Part D will be a single-blind, randomized,~     placebo-controlled, two period crossover study. The proposed doses for Part D will be 1200 mg~     GSK945237 and 400 mg moxifloxacin.~   "
192880|NCT01039597|"~     A clinical trial is being conducted to test the effects of a potential new treatment in~     patients with ulcerative colitis. Study participants will be given capsules containing either~     ORE1001 or a matching placebo capsule and will take the medicine by mouth for six weeks.~     Study participants will be asked to visit clinic sites where they will be asked questions~     about their ulcerative colitis. Small samples of blood will be be drawn at study visits to~     monitor the participant's health and a tiny sample of tissue will be taken in an endoscopy at~     two times to determine whether the disease is getting better or worse.~   "
192881|NCT01039584|"~     This was a study that compared the efficacy and safety of a generic butoconazole nitrate~     vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of~     vulvovaginal candidiasis caused by Candida species.~   "
192882|NCT01039571|"~     The purpose of this study is to determine whether double row repair is better in healing than~     traditional single row repair in arthroscopic rotator cuff repair.~      Our null hypothesis is there are no differences in clinical and structural results~   "
192883|NCT01039558|"~     We will estimate the responses of lansoprazole and ecabet sodium combination therapy and~     compare with lansoprazole and placebo therapy in patients who need additional therapy after~     standard proton pump inhibitor treatment for 4week or more in recurrent gastroesophageal~     reflux disease.~   "
192884|NCT01039545|"~     We propose to perform a randomized controlled patient and assessor blind trial in women~     between the ages of 18 to 70 years with acute uncomplicated UTI to evaluate initial~     symptomatic treatment for 3 days with the non-steroidal anti-inflammatory drug diclofenac~     (experimental intervention) against immediate antibiotic treatment with norfloxacin for 3~     days (control intervention). Both interventions are followed by optional delayed antibiotic~     treatment with single dose fosfomycin if deemed necessary by the patients. The primary~     objective is to determine whether initial symptomatic treatment followed by optional delayed~     antibiotic treatment (experimental intervention) is non-inferior to immediate antibiotic~     treatment (control intervention) in terms of symptom resolution.~   "
192885|NCT01039532|"~     It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen &~     Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in type~     2 diabetes mellitus patients. In this study the investigators evaluated whether Biphasic~     Human Insulin can be used in a thrice daily regimen in place of BIAsp.~      As the regimen is less expensive and one prick less than the basal-bolus regimen, it can be a~     good alternative for a diabetics in India.~      This is a 12 week Open labelled parallel-Randomised controlled pilot study - 50 patients with~     type 2 Diabetes mellitus was selected after satisfying the inclusion and exclusion criteria's~     .Metformin and pioglitazone were continued and they are randomised into 2 groups at base line~     and was allotted into any of the two regimens.~        1. Basal detemir + bolus aspart or~        2. Thrice Daily Biphasic Human Insulin Regimen.~      The two regimens were compared by the following variables:~      Primary endpoint:~      Glycaemic control~      Secondary endpoint:~      Weight gain, Hypoglycaemic episodes, Adverse effects and Cost effectiveness~   "
192886|NCT01039519|"~     The purpose of this study is to determine if STA-9090 is effective in the treatment of~     patients with metastatic and/or unresectable GIST.~   "
192887|NCT01039506|"~     The purpose of this study is to examine the correlation between UGT1A1 genotypes and the~     efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic~     colorectal cancer.~   "
193061|NCT01037179|"~     The objective of this study is to assess safety and efficacy of long-term use of AL-4943A~     (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic~     conjunctivitis.~   "
192889|NCT01039480|"~     Resistance to antiplatelet drugs (aspirin, clopidogrel) is a recognized phenomenon with a~     prevalence from 17% to 35%. Resistance as detected by in vitro tests such as Multiple~     Electrode Aggregometry (MEA) has been shown to predict clinical therapy failure. Resistance~     can be caused by clinical, cellular and pharmacogenetic factors. Non compliance is suspected~     to be an important contributing factor. In this study, compliance will be assured with an~     electronical compliance monitoring system. Factors to non response will be identified to find~     plausible explanations when in vitro platelet aggregation inhibition is insufficient despite~     assured compliance. This study will help to disclose the relationship between compliance,~     biomarker and clinical outcome as well as to quantify the impact of non compliance to the~     resistance phenomenon as measured by MEA.~   "
192890|NCT01039467|"~     The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China.~     The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular~     Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients. The~     COMPARE-Adapta study will also observe atrial fibrillation (AF) burden as demonstrated by~     Cardiac Compass® and the clinical profile Adapta® pacemaker patients.~   "
192891|NCT01039454|"~     This novel compound is a new experimental treatment that may help people to stop compulsive~     overeating. Compulsive overeating or binge eating is one of the main reasons why people are~     overweight or obese. Recent research has shown that some kinds of overeating may be linked to~     a brain chemical called dopamine. There is some evidence that blocking the action of this~     chemical in animals can reduce food intake, particularly of foods that are high in fat and~     sugar. The purpose of this study is to find out if this compound (which blocks the effects of~     dopamine) has the same effect in overweight or obese people, as it does in animals.~   "
192892|NCT01039441|"~     This prospective, randomized controlled trial was designed to compare the efficacy of a~     simple maneuver using lower airway pressure (30 cm H2O) and intraperitoneal instillation of~     bupivacaine, alone or in combination, to reduce shoulder pain after gynecologic laparoscopy.~      Patient aged 15-65 years, scheduled for laparoscopic surgery for benign adnexa disease will~     be eligible for the study. Patients will be excluded from analysis if the procedure requires~     conversion to a laparotomy, an operative time > 3 hours, or interpretation of pain is~     impossible due to serious adverse effects~      240 patients will be randomly assigned to one of four groups Upon completion of surgery, the~     patient is placed in the Trendelenburg position (30 degrees), and one of four procedures is~     followed. For group A (control), 50 ml of normal saline is instilled under the diaphragm and~     CO2 is removed by manual deflation of the abdominal cavity through the cannula; For group B,~     a mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under~     the diaphragm and CO2 is removed by manual deflation of the abdominal cavity through the~     cannula; For group C, 50 ml of normal saline is instilled under diaphragm and CO2 was removed~     by means of a pulmonary recruitment maneuver consisting of five manual inflations of the lung~     with a maximum pressure of 30 cm H2O. The anesthesiologist holds the fifth positive pressure~     inflation for approximately 5 seconds. During these maneuvers, the surgeon will be instructed~     to ensure that the trocar sleeve valve is fully open to allow the CO2 gas to escape. For~     group D, patients receive an instillation of a mixture of 50ml solution in combination with~     the clinical maneuver.~      Patients will be given a questionnaire with the pain question represented as a visual analog~     scale (VAS) preoperatively. Patients will be asked to fill out the questionnaires during the~     first 24 hours after surgery to determine the frequency and severity of their shoulder pain.~     All patients are instructed to record the pain scores regarding their shoulder pain only. The~     degree of postoperative shoulder pain will be assessed using VAS at 1, 6, 12, and 24 hours~     postoperatively. The VAS, with scores ranging from 0 (no pain) to 10 (excruciating pain), is~     constructed without numeration, thus allowing patients to mark a point along the scale that~     best represented their pain at that time.~      In addition, the following parameters are recorded on the case report form by the~     investigators: operative time, blood loss, the length of hospital stay, analgesic use, and~     incidence of postoperative events.~   "
192893|NCT01039428|"~     This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum,~     when given three times a day for 3 weeks to the hemodialysis (HD) patients with~     hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium~     carbonate or sevelamer hydrogen chloride.~   "
192894|NCT01039415|"~     The purpose of the study is to determine why and how marijuana users stop or reduce their~     marijuana use.~   "
192895|NCT01039402|"~     The purpose of this study is to evaluate connection between GP's estimation of cardiovascular~     risk and theoretical calculation.~   "
192896|NCT01039389|"~     The purpose of this study in patients with chronic stable coronary artery disease treatable~     by percutaneous coronary intervention (PCI) is to evaluate the long-term efficacy and safety~     of the orally taken selective I(f)-inhibitor Ivabradine (Procoralan®, Servier Switzerland)~     with regard to the promotion of collateral growth.~   "
192897|NCT01039376|"~     The purpose of this study is to determine if maintenance therapy with ofatumumab will prolong~     remission in patients with CLL who have responded to second or third line treatment. This~     study will also evaluate the safety of ofatumumab maintenance compared to observation (the~     current standard of care). This study was co-developed with the HOVON and NORDIC CLL group~     and will be conducted as a collaborative effort with GSK.~   "
192898|NCT01039363|"~     The prognosis of elderly patients with relapsed or refractory acute myeloid leukemia (AML) is~     grave. Because of their chronological age and/or the presence of multiple co-morbidities,~     treatment-related mortality in elderly patients with AML is quite high although higher~     intensive treatment is mandatory to overcome chemoresistant characteristic of their disease.~     Several regimens have been evaluated as salvage chemotherapy for relapsed or refractory AML~     such as Mitoxantrone/High dose Cytarabine or Amsacrine/High dose Cytarabine. These regimens~     could achieve complete remission (CR) in a part of patients, but resulted in higher treatment~     related mortality (TRM). Accordingly, less intensive salvage regimen is needed for elderly~     patients with relapsed or refractory AML.~      The activity of histone deacetylase (HDAC) inhibitor, Vorinostat or Suberoylanilide~     hydroxamic acid (SAHA), against AML has been suggested in cell line models and in animal~     model as well as in a phase 1 trial. The phase 1 study determined the MTD of oral Vorinostat~     as 200mg twice daily or 250mg thrice daily. In addition, the phase 1 trial showed the~     antitumor activity of Vorinostat with 17% of response rate in patients with advanced leukemia~     or myelodysplastic syndrome (MDS). Accordingly, further study is recommended to demonstrate~     the clinical activity of Vorinostat in AML.~      In terms of the combining drug with Vorinostat, anthracycline is one of the best candidate. A~     in vitro study demonstrated that the combination of anthracycline (esp. idarubicin) with HDAC~     inhibitor have significant clinical activity against leukemia. Another candidate is~     Gemtuzumab ozogamicin, which is a calicheamicin-conjugated antibody directed against CD33~     antigen on AML blasts. The U.S. FDA also approved the use of GO in relapsed AML as a~     monotherapy. A study also showed that the combinational therapy of GO with attenuated doses~     of standard induction chemotherapy could successfully induce CR without increasing~     treatment-related mortality in AML patients aged 55 or older. A in vitro study reported that~     HDAC inhibitor valproic acid augmented the clinical activity of GO toward CD33+ AML cells.~     The study demonstrated that the strategy using HDAC inhibitor together with GO could~     potentially induce synergistic proapoptotic activity against AML blasts without increasing~     toxicity. In our center, so far we treated relapsed or refractory AML patients using the~     salvage regimen including GO (3mg/m2/dayx1day) plus attenuated Idarubicin/Cytarabine~     (Idarubicin 12mg/m2/day for 2 days and intermediate dose Cytarabine). So far, the CR rate~     from the regimen is around 50% without increasing TRM. Accordingly, we will determine the~     efficacy and toxicity of Vorinostat-incorporating salvage regimen based on the GO+IA~     chemotherapy in patients 50 years old or older with relapsed or refractory AML.~   "
192899|NCT01039350|"~     This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to~     treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist~     of a 14-day screening period followed by a maximum 24-week treatment period and a final~     visit.~   "
192900|NCT01039337|"~     The purpose of the study is to evaluate the effect of manual treatment and a patient~     education programme for patients without indication for hip surgery.~   "
192901|NCT01039324|"~     The purpose of this study is to improve patient care and safety while decreasing ED visit~     rates by sending specific information about care transitions related to hospital admission~     and discharge and emergency department and specialty care visits to primary care practices,~     care managers and patients with the use of health information technology (HIT) shared across~     a community-based network of providers.~      Cycle 1 focuses on the impact of notices about ED encounters and hospitalizations derived~     from billing data that are sent to care managers for all 47,000 patients in the Northern~     Piedmont Community Care Network (NPCCN). Cycle 2 explores the impact of letters sent to~     patients, and care event reports sent to a patient's medical home in addition to notices sent~     to care managers about ED encounters, hospitalization and specialty care based on ADT~     (Admission Discharge Transfer) and billing data on 4,600 patients with complex health needs.~   "
192902|NCT01039311|"~     Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide~     images with good sensitivity and specificity to determine the presence of endobronchial~     malignancies.~   "
192903|NCT01039298|"~     Oral squamous cell carcinoma (SCC) is a global disease responsible for ~300,000 new cancer~     cases each year. Local recurrence (~30% of cases) and formation of second primary malignancy~     are common.2, 3 Cosmetic and/or functional compromise associated with treatment of disease~     stage is often significant. These statistics underscore the urgent need to develop a better~     approach in order to control this deadly disease.~      It is becoming increasingly apparent that oral cancers develop within wide fields of diseased~     tissue characterized by genetically altered cells that are widespread across the oral cavity~     and present in clinically and histologically normal oral mucosa. Complete removal of these~     lesions is difficult because high-risk changes frequently go beyond clinically visible tumor.~     In recognition of this, current 'best practice' is to remove SCC with a significant width~     (usually 10 mm) of surrounding normal-looking oral mucosa. However, since occult disease~     varies in size such approach often results in over-cutting (causing severe cosmetic and~     functional morbidity) or under removal of disease tissue, as evidenced by frequent positive~     surgical margins and high local and regional recurrence - a failure of the 'best practice.~      There is a wealth of literature that supports the use of tissue autofluorescence in the~     screening and diagnosis of precancers in the lung, uterine cervix, skin and oral cavity. This~     approach is already in clinical use in the lung and the mechanism of action of tissue~     autofluorescence has been well described in the cervix. Changes in fluorescence reflect a~     complex interplay of alterations to fluorophores in the tissue and structural changes in~     tissue morphology, each associated with progression of the disease.~      As one of the internationally leading teams in applying tissue fluorescence technology, we~     have shown that direct fluorescence visualization (FV) tools can identify clinically visible~     or occult premalignant and malignant lesions that are associated with lesions at risk, with~     high-grade histology and high-risk molecular change. In a recently small scaled,~     retrospective study, we have shown that FV helped surgeons in the operating room to determine~     the extent of the high-risk FV field surrounding the cancer and resulted in remarkably lower~     2-year recurrence rates (0% for FV-guided vs. 25% for those without FV-guided approach).~     There is need to design a larger scale prospective, randomized controlled (Phase III) trial~     to gather strong evidence in proving the efficacy of the surgery approach using this adjunct~     tool.~      To establish the evidence supporting the change in clinical practice using FV-guided surgery.~     There are 3 objectives.~      2.1. Objective 1 (Clinical evidence): To assess the effect of FV-guided surgery on the~     recurrence-free survival of histologically confirmed disease within the context of a~     randomized controlled trial (efficacy). Hypothesis: FV-guided surgery will increase the~     recurrence-free survival.~      2.2. Objective 2 (Quality of Life evidence): To establish the cost per recurrence prevented~     for this approach and assess quality of life issues. Hypothesis: FV-guided surgery can be~     delivered in a cost effective manner and improve the quality of life of patients 2.3~     Objective 3 (Scientific/Molecular evidence): To assess the presence of previously validated~     molecular markers (microsatellite analysis, LOH) and histological change (quantitative~     pathology) in surgical margins in a nested case-control study involving a tumor bank created~     within this project. Hypothesis: FV-guided surgery will spare normal tissue at the same time~     improving capture of high-risk tissue.~   "
192904|NCT01039285|"~     Advances in perinatal care have made it possible to improve the survival of the most immature~     neonates, but at the cost of an increase in the population at risk of developing~     bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of~     BPD are not always effective, or related to major side effects. The physiopathological~     factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the~     use of an exogenous surfactant in neonates presenting with pulmonary disease requiring~     mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation~     and thus promote pulmonary healing and growth.~   "
192905|NCT01039272|"~     The aim of this study is to analyze oral squamous cell carcinoma and healthy oral mucosa for~     the possible presence of Epstein-Barr virus (EBV).~   "
192906|NCT01039259|"~     Biofilms on oral piercings may serve as a bacterial reservoir and lead to systemic~     bacteraemia or local transmission of periopathogenic microbiota.~      The investigators hypothesize that there are microbiological differences in bacterial samples~     collected from tongue /or lip piercings made of different materials. The investigators also~     hypothesize that the piercings carry the same characteristic bacteria as found in the~     piercing channels and that independently the biofilm on the tongue/adjacent teeth is similar~     to the other study locations.~      85 subjects with tongue and 85 subjects with lip piercing will participate. Periodontal~     clinical parameters, traumata of hard tissues, and characteristics of the stud are evaluated.~     Sterile piercings of four different materials will be randomly allocated to the study~     subjects. After two weeks, microbiologic samples are collected and are processed by~     checkerboard DNA-DNA hybridization methods.~   "
192907|NCT01039233|"~     The objective of this study is to compare the rate and extent of absorption of bicalutamide~     50 mg tablet (test) versus Casodex (reference), administered as 1 x 50 mg tablet under~     fasting conditions~   "
192908|NCT01039220|"~     To estimate the incidence of H1N1v influenza-like illness and to study the risk factors for~     serious influenza forms during pandemic period in French HIV infected patients.~        -  Definitions:~             -  Influenza like illness is defined as fever> 37°8C and cough or pharyngalgia.~               (Centers for Disease Control definition).~             -  Serious forms of influenza-like illness is defined by hospitalization within 14~               days onset of symptoms or death attributed to influenza like illness.~        -  Design:~             -  Survey sampling for estimating H1N1v influenza-like illness incidence.~             -  Out of approximately 50 000 patients under follow-up in one of the 40 ANRS centres,~               a sub-group will be selected by random sampling. Sampling will be stratified by~               centre and sampling fraction per site will vary in order to select 60 to 80~               patients for this study per site. A total of 2500 to 3000 patients will be selected~               to allow for estimating the incidence of H1N1v influenza-like illness with an~               adequate precision.~      Selected patients will be asked to contact the clinical staff on site as soon as any~     influenza like symptoms appear. In the case of influenza like illness patients are requested~     to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for~     diagnosis of A(H1N1)v infection.~      Nested case-control study for the determination of risk factors for serious forms:~        -  Cases: Serious forms (see definition above) identified by any clinical site or~          hospitalisation unit.~        -  Controls: Patients of the randomly selected sample (see survey sampling above),~          presenting with influenza-like illness without any criterion for severity.~      Exhaustivity check:~      The exhaustivity of symptomatic forms will be assessed a posteriori by merging information~     from all available data sources.~   "
192909|NCT01039207|"~     This phase II trial studies how well rilotumumab works in treating patients with ovarian~     epithelial, fallopian tube, or primary peritoneal cancer that has failed to respond to other~     therapies (persistent) or has returned after a period of improvement (recurrent). Rilotumumab~     is a type of drug called a monoclonal antibody, and may interfere with the ability of tumor~     cells to grow and spread by targeting certain cells and blocking them from working.~   "
192910|NCT01039194|"~     The purpose of the study is to find out if the plasma concentration of galantamine extended~     release is changed when BMS-708163 is administered at the same time.~   "
192911|NCT01039181|"~     Cholangiocarcinoma (CCA), cancer of the bile duct, is the first cause of cancer death of the~     people in the northeast of Thailand. The incidence of CCA in this region is highest not only~     in the country but in the world. CCA is a slow growing but highly metastatic tumor. At~     present, there is no standard chemotherapy or effective treatment for CCA. Most of the~     patients have short survival after diagnosis. Strong evidences from in vitro, animal and~     clinical studies indicate that vitamin D can prevent and control growth of cancer. Our~     preclinical studies in CCA cell lines, animal and patient tissue culture indicate that~     vitamin D effectively reduce growth of CCA. Supplementation of vitamin D to chemotherapeutic~     drugs enhance drug toxicity and better response. At present, there are several clinical~     trials in USA on supplementation of vitamin D or its analogs to cancer patients. The side~     effect or toxicity of using vitamin D supplementation is low, some patients had stable~     disease and some had good response. The current study is set up a clinical trial phase II of~     vitamin D (calcitriol) in combination with 5-fluorouracil, Mitomycin C and Leucovorin in an~     open label-non-randomized study to evaluate the tumor response in patients with advanced~     intrahepatic cholangiocarcinoma. This study will provide an alternative/effective~     chemotherapy treatment for CCA patients. Better survival and improved quality of life are~     also expected.~   "
192912|NCT01039168|"~     The study aims to evaluate the effect on return to work of a workplace intervention with~     patients being treated for burnout. The intervention intends to reduce job-person mismatch~     through patient-supervisor communication.The hypothesis is that the intervention group will~     show a more favourable outcome than a control group with respect to return to work.~   "
193062|NCT01037166|"~     The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA~     measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the~     pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete~     response to current lamivudine therapy~   "
192913|NCT01039155|"~     This phase I clinical trial studies the side effects and the best dose of azacitidine and~     oxaliplatin in treating patients with advanced cancers that do not respond to treatment or~     have returned after any platinum therapy. Azacitidine is designed to activate (turn on)~     certain genes in cancer cells whose job is to fight tumors. Oxaliplatin is designed to block~     the growth and spread of new cancer cells, eventually destroying them, by damaging their~     deoxyribonucleic acid (DNA). Giving azacitidine with oxaliplatin may kill more cancer cells~     and may also reverse resistance to platinum-based drugs.~   "
192914|NCT01039142|"~     In this study, the investigators will intend to compare the efficacy and safety of various~     doses of acitretin in a randomized double blind manner in patients with severe plaque-type~     psoriasis, by i) studying the change PASI score from baseline as a measure of efficacy ii)~     determining the frequency of side effects at various doses. Sixty patients will be recruited~     from Psoriasis Clinic of Department of Dermatology, Venerology and Leprology, PGIMER.~     Patients will be randomly assigned to one of the three groups: Group A, consisting of 20~     patients, will be administered acitretin 25 mg/ day ,Group B, consisting of 20 patients, will~     be administered acitretin 35 mg/day and GROUP C consisting of 20 patients, will be~     administered acitretin 50 mg/day This therapy will be continued until PSORIASIS AREA AND~     SEVERITY INDEX (PASI) scores are reduced to < 25% of the original scores or 12 weeks,~     whichever comes earlier. It is expected that acitretin at higher doses will be more~     efficacious . As the exact etiopathogenesis of psoriasis is not fully known, it is difficult~     to provide a definite cure to all patients, though the disease activity can be controlled to~     a great extent with various treatment modalities. However the dosage of acitretin be adjusted~     according to response of the patients and tolerability of side effects.~   "
192915|NCT01039129|"~     The is a pilot study to evaluate the safety and efficacy of hybrid~     transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of~     the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the~     gallbladder) will be performed through a vaginal incision with an additional small incision~     in the umbilicus.~   "
192916|NCT01039116|"~     The purpose of this study was to determine whether once-weekly exposure to a program that~     fostered self-esteem building, and improvements in nutrition and physical activity behaviors~     would reduce risk of type 2 diabetes in overweight, inner-city, African American children~     when compared to a control group.~   "
192917|NCT01039103|"~     Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with~     Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily~     infusions of SoluMedrol. Main objective is to assess the occurrence of new~     gadolinium-enhanced T1-weighted lesions at week 8 vs week 1 after treatment.~   "
192918|NCT01039090|"~     In Parkinson's disease, treatment mainly aims to improve motor functions. However, other~     dysfunctions are often observed in Parkinson's patients, and may have important consequences~     on the quality of life of patients.~      Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety~     for example. As this kind of troubles is worrying for the patient himself (herself) and~     his/her family, treatment needs to take into account those troubles in addition to motor~     difficulties. In our centre, we have already used continuous Apomorphine infusions among~     Parkinson's patients and it seems to have good results. The present study aims to objectively~     assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological~     functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan~     measures.~   "
192919|NCT01039077|"~     Gastric banding has been shown to significantly reduce weight and has been approved as a~     treatment of morbid obesity. The standard laparoscopic operation requires five small~     incisions for the introduction of instruments and the band into the patient's abdomen. We~     have developed a technique for performing this operation through a single incision at the~     belly button. This study compares this method to the conventional 5-incision approach.~   "
192920|NCT01039051|"~     Previous studies have shown Doing the month, a traditional practice for postpartum women in~     China and other Asian countries, may be associated with higher prevalence of postpartum~     problems. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes~     of diet and lifestyle interventions in Chinese postpartum women.~   "
192921|NCT01039038|"~     The objective of the trial is to evaluating the feasibility of dose increase by a boost of~     curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in~     intermediate risk in prostate cancer.~   "
192922|NCT01039025|"~     To determine the efficacy of high-dose topotecan, cyclophosphamide and melphalan in patients~     with Multiple Myeloma.~   "
192923|NCT01039012|"~     This study will assess the effectiveness of Tai Chi to affect the rate of bone loss in~     post-menopausal women who have been diagnosed with the initial stages of bone thinning.~   "
192924|NCT01038999|"~     The main goal is to confirm, among HIV1-infected patients, data from in vitro studies showing~     that antiretroviral therapies induce an accelerated aging through the same mechanisms than~     genetic laminopathies or than physiological  aging, that is through the synthesis and~     persistence of farnesylated prelamin A. The secondary goal is to measure the impact of HIV~     infection and of antiretroviral therapies on markers of cell ageing (proteasome,~     mitochondria, telomere). The perspective is to fix antiretroviral therapy side effects using~     the same drug combination that will be used in few weeks in Marseille to treat children~     suffering from progeria~   "
192925|NCT01038986|"~     A post-marketing multi-center observational study to provide data describing the safety and~     effectiveness of CUREXCELL™ as it is applied in a real-life setting for treatment in patients~     with chronic and/or refractory wounds.~   "
192926|NCT01038960|"~     Interventional study in patients with ICD. Controlled, open intervention with exercise~     training. Assessment of changes in physiological and psychological parameters.~   "
192927|NCT01038947|"~     The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of~     single and multiple intramuscular doses of Uricase-PEG 20~   "
192928|NCT01038934|"~     The aim of this study is to analyze genomic DNA of buccal cytobrush stored in three means~     conservation.~   "
192929|NCT01038921|"~     This trial seeks to compare the effects of melatonin supplementation versus placebo in~     subjects with the metabolic syndrome.~   "
192930|NCT01038908|"~     The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue~     dye and the breast drainage system with a radioactive material. By identifying the arm~     lymphatics they can be protected during surgery and this may decrease the occurrence of~     lymphedema. The information obtained in this study may provide us with better surgical~     techniques to identify and protect the arm lymphatic drainage system in the axilla.~   "
192931|NCT01038895|"~     The main objective of this study is to assess the extent and trend in time of antiproteinuric~     effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg~     daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators~     will also evaluate:~        1. Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks~          at various visits~        2. Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at~          various visits 3. Average night, as determined by ABPM, systolic and diastolic blood~          pressure checks at various visits~   "
192932|NCT01038882|"~     The Flexible Bronchoscopy (FB) is a diagnostic and therapeutic procedure which is not usually~     tolerated by the patient. This makes the examination more difficult and a repetition of the~     examination, if necessary, resulting in a lower diagnostic performance.~      Furthermore, there is nowadays little information with a highly obvious level about the~     relationship between sedation and the patient´s satisfaction with the FB.~      Midazolam is one of the most commonly used sedatives at the beginning for its rapid onset~     property and brief duration of action with sedatives, anxiolytics and amnesia properties.~      The principal aim of our study is to analyse if the use of a local anaesthetic with midazolam~     whilst performing an FB improves the quality of examination in terms of tolerance for the~     patient. It would also be of interest to know if there is an improvement in the acceptance of~     a second or further FB and if this improves the satisfaction of the Bronchoscopist as far as~     the examination performed is concerned.~   "
192933|NCT01038869|"~     Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with~     skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related~     to acne vulgaris. However, it has not been clinically tested for this purpose. The current~     study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris~     and PIH.~   "
192934|NCT01038856|"~     The primary objective of this study is to determine the overall response rate to erlotinib in~     patients with polycythemia vera (PV). Response rate will be assessed by improvement in the~     complete blood count, ultrasound of the spleen, and JAK2 molecular status. It is purposed in~     this study to explore a possible molecular targeting of the driving mechanism of PV.~   "
192935|NCT01038843|"~     To investigate the effect of VA106483 on nocturia related clinical outcomes compared to~     placebo.~   "
192936|NCT01038830|"~     The aim of this study is to evaluate the change of QuantiFERON-TB gold in tube assay (QFT)~     during the treatment of active tuberculosis.~   "
192937|NCT01038817|"~     This study questions the interest of fluoride varnish dental application in preventing tooth~     decay in a population of institutionalised elderly people.~   "
192938|NCT01038804|"~     The purpose of this study is to evaluate survival, response rate, safety and tolerability of~     YM155 given in combination with docetaxel as first-line treatment in subjects with human~     epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.~   "
192939|NCT01038791|"~     At present, little data is available in the medical literature regarding the affects of~     humidification on NIMV efficacy, sleep quality and upper airway symptoms in patients~     undergoing nocturnal NIMV.~      The aim of the present pilot study is to assess the impact of two humidification systems on~     sleep quality, NIMV efficacy, patient-ventilator interaction, prevalence of NIMV side~     effects, compliance to treatment, in a group of stable patients already enrolled in a~     long-term nocturnal mechanical ventilation program for chronic hypercapnic respiratory~     failure or sleep hypoventilation.~   "
192940|NCT01038778|"~     This phase I/II trial studies the side effects and best dose of entinostat when given~     together with aldesleukin and to see how well this works in treating patients with kidney~     cancer that has spread to other places in the body. Entinostat may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Aldesleukin may stimulate the~     white blood cells to kill kidney cancer cells. Giving entinostat together with aldesleukin~     may be a better treatment for metastatic kidney cancer.~   "
192941|NCT01038765|"~     The purpose of this study is to investigate the effectiveness and possible mediating factors~     of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.~   "
192942|NCT01038752|"~     The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic~     dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with~     non-small cell lung cancer.~   "
192943|NCT01038739|"~     The purpose of the study is to determine which dose of mesalazine granules compared to~     placebo is more effective in the prevention of recurrence of disease.~   "
192944|NCT01038726|"~     The purpose of this study is to gain a better understanding of the effects of exercise and~     cognitive training on improving brain function in healthy older adults who may be at risk for~     developing Alzheimer's Disease.~   "
192945|NCT01038713|"~     This is a single center, randomized, unblinded study to compare the rate of occlusion of~     plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically~     resectable disease or those undergoing neoadjuvant chemoradiotherapy. We will also compare~     occlusion rates between uncovered metal and fully covered metal biliary stents in those~     patients determined to have surgically unresectable disease.~   "
192946|NCT01038700|"~     This part of the project aims to describe changes in markers of vascular competence~     (Endothelial Microparticles Platelet (EMP), Circulating endothelial cells (CEC) and~     Circulating endothelial progenitors (EPC)) at different ages of lifespan both in~     physiological state and in response to hypoxia-induced vascular stress.~   "
192947|NCT01038687|"~     This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose~     response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on~     gastric, intestinal and colonic transit in patients with functional constipation.~   "
192948|NCT01038674|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.~   "
192949|NCT01038661|"~     The Primary Objective is to evaluate the progression-free survival (PFS).~      The secondary objectives are:~        -  To compare the disease control rates of different doses of Docetaxel+Cisplatin as~          first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST)~          criteria;~        -  To evaluate the overall response rate (ORR);~        -  To evaluate the time to disease progression (TTP);~        -  To evaluate the overall survival (OS);~        -  To evaluate the toxicity.~   "
192950|NCT01038648|"~     The hypothesis is, in subjects with persistent impaired glucose tolerance(IGT) , sitagliptin~     will decrease the conversion rate to diabetes as compared to a placebo in three years.~   "
192951|NCT01038635|"~     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of~     lenalidomide that can be given in combination with azacitidine to patients with MDS or AML.~      The goal of Phase 2 of this study is to learn if the combination dose of azacitidine and~     lenalidomide found in Phase 1 can help to control MDS and/or AML.~      The safety of this drug combination will be studied in both Phases.~   "
192952|NCT01038622|"~     The main objective of this proof-of-concept study is to demonstrate that the only~     administration of L-arginine, based on a suspected deficit monitored by nasal nitric oxide~     measurement, can improve immune functions in critically ill patients at high risk of~     nosocomial infection.~   "
192953|NCT01038609|"~     The primary purpose of this study was to evaluate analgesic efficacy and safety of~     hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain~     following primary unilateral first metatarsal bunionectomy.~   "
192954|NCT01038596|"~     Osteoarthritis (OA) is one of the most frequent musculoskeletal disorders and represents the~     main indication for total joint arthroplasty. Multipotent mesenchymal stromal cells (MSCs)~     can be easily isolated and culture expanded from bone marrow aspirates and provide an~     excellent source of progenitor cells for cell-based regeneration strategies due to their ex~     vivo differentiation and proliferation capacity. Although there are hints that MSCs derived~     from OA patients may exhibit altered function the role of MSCs with respect to disease~     development and progression of OA is not clearly understood to date. To assess whether~     advanced-stage OA affects MSCs' suitability for musculoskeletal regenerative therapy, in the~     present study, we compare proliferation and differentiation potential of MSCs from~     osteoarthritic versus healthy donors.~   "
192955|NCT01038583|"~     The ASPREE study will examine whether the potential benefits of low dose aspirin~     (particularly preventing heart disease, stroke, certain cancers and dementia) outweigh the~     risks (particularly bleeding) in people over age 65.~      ASPREE will determine whether taking a daily low-dose aspirin will extend the length of a~     disability-free life in healthy participants aged 65 years and above.~   "
192956|NCT01038570|"~     The role of oxytocin (OT) is already known in the regulation of satiety but some clinical~     studies demonstrated that OT participates also in the regulation of social behavior by its~     implication on a better comprehension of emotion which plays a role on theory of mind and~     empathy. By the way, these 2 behaviors are deviants for patients with Prader-Willi Syndrome~     (PWS). Actually, no study was led on the effect of OT on PWS patients but Swaab and al in~     1995 showed a significant reduction in number and in volume of neurons expressing OT in the~     paraventricular nucleus of PWS patients. Recent data were obtained studying OT in patients~     with autism which showed a link between the deregulation of OT and the autistic pathology.~     Clinical and imaging studies obtained with PWS and autistic populations make us believe that~     some mechanisms are common between these two pathologies.~      The objectives of this project are:~        1. to look for an influence on the understanding of the social codes of the PWS patients,~        2. to look for an influence on the behavior of stress and anxiety and on the regulation of~          eating habits when patients receive a nasal pulverizing of OT.~   "
192957|NCT01038557|"~     The purpose of this study is to look at red blood cell(RBC)transfusions in trauma patients~     and evaluate for any differences between the age of the RBCs and how they were stored. The~     investigators will specifically look for the following differences between study groups:~        1. the transfused red blood cells' ability to delivery oxygen to the tissues~        2. changes in the how the RBCs' look or act under a microscope and~        3. how the subject's internal organs are working and if they develop any infections~   "
192958|NCT01038544|"~     The purpose of this study is determine if performing endobronchial ultrasound (EBUS) in~     addition to standard endoscopic ultrasound (EUS) can increase the precision and accuracy of~     staging esophageal cancer in comparison to EUS alone. The expectation is that EBUS can be~     used to biopsy lymph nodes that: (1) because of their position in the mediastinum would be~     inaccessible to EUS, or (2) would be inaccessible due to their position behind the esophageal~     tumor.~   "
192959|NCT01038531|"~     Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a~     spectrum of clinical syndromes of rapid respiratory system deterioration that are associated~     with both pulmonary and systemic illness. These syndromes are associated with 30-40%~     mortality with our current standard of care and are responsible for approximately 75,000~     deaths in the US yearly. Current evidence-based care of ALI consists of a strategy of~     mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit~     further stretch-induced lung injury exacerbated by the ventilator. However, this strategy has~     been shown to be associated with increased lung injury in a subset of patients and still is~     associated with about a 30% mortality rate. Airway pressure release ventilation (APRV) is a~     different, non-experimental strategy of mechanical ventilation currently in routine clinical~     use. APRV is a pressure-cycled ventilator mode that allows a patient a greater degree of~     autonomy in controlling his or her breathing pattern than ARDSNet ventilation. Use of APRV~     has been associated with better oxygenation, less sedative usage, and less~     ventilator-associated pneumonia in small studies compared with other ventilator modes.~     However, debate exists over whether APRV might result in decreased or increased~     ventilator-associated lung injury when compared with ARDSNet ventilation. We intend to~     implement a randomized, cross over study looking at biomarkers of lung injury in patients~     with acute lung injury during ventilation with APRV and using the ARDSNet protocol. Our~     hypothesis is that airway pressure release ventilation is associated with lower levels of~     lung injury biomarkers than ARDSNet ventilation.~   "
193272|NCT01033786|"~     The purpose of this study is to assess length of hospital stay and perioperative~     complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year~     time period, who did not complete a questionnaire on post-operative recovery.~   "
192960|NCT01038518|"~     The overall aim of the Health2010-14 is to monitor the prevalence and trends of common~     chronic diseases (osteoporosis, diabetes, cardiovascular disease, asthma, allergy, and~     eczema) that are often un-diagnosed in the general population as well as biomarkers of~     micronutrient status. Specific aims include identification of novel lifestyle and genetic~     risk factors for the above diseases by investigating gene-lifestyle interactions.~   "
192961|NCT01038505|"~     The investigators center has also analyzed data over the last 7 years from deceased donor~     (DD) and living donor (LD) kidney transplant recipients who were randomized into 3~     immunosuppressive arms between 2000 and 2001. Thus the goal of the investigators study is to~     reduce the toxic effects of traditional immunosuppressive regimens involving high-dose~     calcineurin inhibitor agents by comparing low-dose TAC-MYF with low-dose TAC and de novo SRL~     regimens. In order to minimize exposure to TAC, the investigators center has previously shown~     favorable outcomes using combination Thymoglobulin and Zenapax (Daclizumab) for~     anti-lymphocyte induction in the investigator population of patients.~   "
192962|NCT01038492|"~     Smoking cessation is often difficult for smokers to achieve for a variety of reasons~     including: difficulty with nicotine withdrawal, failure to perceive the benefits of smoking~     cessation, and failure to perceive the risks associated with smoking. We argue that the most~     effective biomarkers to affect perceptions of harm, especially for lung cancer, are those~     that signal progression towards disease development Proposed is a pilot study of educating~     smokers about the role of genetics and lung cancer in Durham VA out-patient clinics. The goal~     of this pilot study is to assess the interest in study participation from the VA smoking~     population, as well as to determine the fraction of subjects who will complete the study to~     power a future larger trial. Interested patients will receive a 15 minute educational~     presentation on the function of p16 and its role in development of lung cancer. They will~     then be assessed for airway obstruction by hand-held spirometry followed by review of a~     questionnaire assessing their understanding of the presented information, their concern for~     developing lung cancer, and their desire to quit smoking. All patients will be offered~     smoking cessation assistance at this point. Enrolled patients will then be given 3 sputum~     cups to take home and return with morning sputum samples by mail. Samples will be assessed~     for evidence of p16 methylation and patients will be informed of the results. Follow-up phone~     interviews will be performed at 2 to 4 weeks after patients have received their results by~     mail to assess their understanding of the results, and their desire to stop smoking. A final~     phone interview will occur approximately 3 months after the sputum testing to assess attempts~     to stop smoking as well as the patients continued understanding of their test results. For~     purposes of this pilot, we are interested primarily in the descriptive statistics (e.g.,~     frequencies) associated with the outcome of each objective (e.g., how many expressed~     interest, how many returned the sputum samples).~   "
192963|NCT01038479|"~     The purpose of this study is to determine if the Childsmile programme (www.child−smile.org)~     with the additional maternal use of xylitol is more effective at reducing dental decay in~     children than a Childsmile program alone.~      The children will be compared in the two groups at age two, to determine how the~     interventions affected the early colonization of mutans streptococci, an important risk~     factor of tooth decay.~      At three and at five years the investigators will also examine the amount of tooth decay in~     these children.~      Using MIDAS (Scotland's national health service dental data) records, the investigators will~     follow the oral health of the children until the age of 5 years.~      Main hypothesis:~      The maternal consumption of xylitol reduces early childhood caries~   "
192964|NCT01038466|"~     The aim of the CHAT study (An open-label, randomized Phase II study of Herceptin~     (trastuzumab), Taxotere® (docetaxel) and Xeloda (capecitabine) in combination, versus~     Herceptin (trastuzumab) plus Taxotere® (docetaxel), in patients with advanced and/or~     metastatic breast cancers that overexpress HER2) was to test the combination of Trastuzumab~     and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally~     advanced or metastatic breast cancer.~      Overall Response Rate was the primary endpoint of the CHAT study. This study failed to meet~     its primary objective of showing a difference between the treatment groups, with equivalent~     high response rates for the Trastuzumab plus Docetaxel and Trastuzumab, Docetaxel plus~     capecitabine arms.~      Secondary endpoints in the CHAT study were Progression-Free-Survival, Time-to-Progression,~     Overall Survival, duration of response and safety profile. Whilst analysis of the existing~     data is consistent with improvement with the triplet therapy, interpretation is compromised~     by the relatively short median follow-up of 24 months. In hindsight the statistical design~     was flawed by selection of a sub optimal primary endpoint and consequently data was collected~     and analysed early in relation to time-dependent endpoints. Beyond CHAT will permit capture~     of mature data for time-related endpoints. Time-to-Progression and Overall Survival are the~     co-primary endpoints for the Beyond CHAT protocol. The impact of treatment following the~     first progression, on survival, will be explored.~      Time-to-Progression will be defined from the time interval between the date of randomisation~     and the occurrence of progressive disease under therapy according to RECIST criteria.~      Overall Survival will be defined as the time from date of randomisation to date of death~   "
192965|NCT01038453|"~     The purpose of this study is to determine whether a daily supplement of vitamin D, taking~     before and during pregnancy, effects child birth weight, pre- and postpartum complication and~     bone mineral density during lactation.~   "
192966|NCT01038440|"~     The purpose of this study is to assess the relationships between dose and time of consumption~     of stearidonic acid (SDA) and eicosapentaenoic acid (EPA) on EPA enrichment of red blood cell~     (RBC) membranes in men and women.~   "
192967|NCT01038427|"~     This study will compare the safety and efficacy of a generic mometasone nasal spray to the~     reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the~     test and the reference formulations will be tested for superiority against a placebo nasal~     spray.~   "
192968|NCT01038414|"~     The purpose of this study is to determine if extending the behavioral smoking-cessation~     treatment period to one year will significantly improve cessation outcomes among those~     planning a quit attempt.~   "
192969|NCT01038401|"~     HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens.~     Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing~     low-level virus replication. This project aims to characterize the residual replication of~     HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid~     tissue.~   "
192970|NCT01038388|"~     The purpose of the study is to evaluate the clinical effectiveness and side effects of the~     vorinostat, bortezomib, lenalidomide, and dexamethasone investigational combination.~   "
193002|NCT01037972|"~     40 patients with osteoarthritis of the knee will be randomly assigned to conventional~     physiotherapy on the one and whole body vibration exercises on the other hand. The duration~     of the training will be 6 weeks, three times a week.~      The outcome will be measured by WOMAC and SF-12 scores relating to pain and quality of life.~     The second outcome criteria will be a motion analysis and balance testing before and after~     the training.~      The follow-up is 26 weeks.~   "
192971|NCT01038375|"~     The purpose of this study is to determine the effectiveness of interventions to improve~     adherence to medication and healthier lifestyle choices on blood pressure over a 6 month~     period in a group of people at high risk for recurrent stroke events. The participants have~     already had a stroke or TIA, and have uncontrolled blood pressure, as well as problems with~     memory and problem-solving, or miss taking medications, or who do not believe in the~     effectiveness of their medications. Interventions focus on motivational interviewing,~     adherence counseling with memory cuing, and self-monitoring of blood pressure.~   "
192972|NCT01038362|"~     The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm~     and thrombosis by production of a variety of regulatory substances, including nitric oxide.~     In patients with atherosclerosis, these functions of the endothelium are impaired and these~     abnormalities may contribute to the development of heart attack and stroke.~      Observational studies have shown that frequent nut consumption decreases the risk of~     cardiovascular disease (CVD), but the mechanisms of benefit have not been fully defined.~     Recent studies suggest that specific fatty acids and flavonoids in nuts may have favorable~     effects on cardiovascular disease. In addition, there is growing evidence that these~     compounds may improve the function of the endothelium.~      The present study is designed to test the hypothesis that an almond-enriched diet will~     improve the function of the endothelium in patients with coronary artery disease. Subjects~     will be enrolled into a randomized, placebo-controlled, crossover study that will compare a~     National Cholesterol Education Program Step 1 diet without nuts to a Step 1 diet that has the~     same number of total calories but includes 3 ounces of almonds daily. Participants will~     consume each diet for six weeks with a four-week rest period between diets. The order of~     diets will be randomized (almonds or no almonds). Dietary assessments via food recall~     questionnaires will be employed at the study entry, end of the four week washout period, and~     end of the second intervention. If subjects are drifting from the recommendations of the STEP~     1 diet, counseling will be given to urge compliance. The primary endpoint will be~     endothelium-dependent flow- mediated dilation assessed by ultrasound. Secondary study~     outcomes will include lipid profiles, markers of inflammation and oxidative stress.~     Enrollment will continue until 40 subjects with complete data are available.~      Patients will be enrolled at Boston Medical Center and the Jean Mayer US Department of~     Agriculture Human Nutrition Research Center at Tufts Medical Center. Dietary interventions~     will be performed at Tufts Medical Center or by telephone. Ultrasound studies and blood~     collection will be performed in the principal investigator's research unit at Boston Medical~     Center.~   "
192973|NCT01038349|"~     The goal of this study is to enable the study sponsor to assess the impact of a marketed or~     validated blood test has on physicians' clinical treatment decision making when treating RA~     patients who have been taking methotrexate.~      Ultimately, the blood test will allow treating physicians to modify current methotrexate~     therapy in partially responding Rheumatoid Arthritis (RA) patients' therapy, on an~     individualized basis, as a means of improving clinical outcomes.~      The study requires a blood sample from RA patients who have been on methotrexate therapy for~     a minimum of 3 months and are having an inadequate response to therapy. Physicians will then~     be provided with the results of the test indicating the methotrexate polyglutamate (active~     metabolites of methotrexate) levels in the patient's red blood cells as a means to help~     determine whether a patient's exposure to methotrexate has been optimized.~   "
192974|NCT01038336|"~     Hearing loss is the most prevalent service-connected disability in the VA. It causes~     communication difficulties, which contribute to isolation, frustration and depression. A~     major cause of hearing loss is from exposure to high levels of sound, and is referred to as~     Noise Induced Hearing Loss (NIHL). Veterans have inevitably been exposed to high levels of~     sound during military service, and even though they may not yet have NIHL, their ears have~     been damaged. Continued noise exposure in civilian life will result in NIHL. However, it can~     easily be prevented by avoiding noise or using hearing protection. Most people are unaware~     that noise damages hearing, and even when they are, they do not use hearing protection. In~     this study we will use a randomized controlled trial to evaluate the short- and long-term~     effectiveness of two forms of education about NIHL that we have developed for Veterans. One~     is a computerized program; the other is a Hearing Conservation Brochure~   "
192975|NCT01038323|"~     Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and~     societal costs in terms of quality of life, social and work functioning, health care use, and~     lost productivity. Although single therapy approaches such as medication, graduated exercise,~     and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the~     majority of FMS continue to report significant levels of pain and pain-related disability.~     Testing the efficacy of using combination therapies such and CBT with medication has~     considerable potential to maximize treatment response. Also, exploring the biological and~     psychological mechanisms underlying combination treatment may pave the way for developing new~     treatments for FMS sufferers.~      We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate~     medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment~     arm in a study that has both time and budgetary constraints, 3) the complexity in~     understanding the mechanism of actions of 3 different modes of intervention in one clinical~     trial, and 4) the desire to explore mechanisms in this program of research, in particular the~     potential effects of a biological intervention (drug) on what is traditionally considered a~     psychological outcome (pain-related attributions and cognition) and the potential effects of~     a psychological intervention (CBT) on what is traditionally considered a physiological~     outcome (pain sensitivity).~   "
192976|NCT01038310|"~     The investigators aim to study whether the nuclear medicine method FP-CIT-SPECT (more details~     see below) allows to predict the further clinical course of Parkinson´s disease. Especially~     the investigators are interested in the motor and cognitive functions of the parkinsonian~     patients.~   "
192977|NCT01038297|"~     The study will investigate the ability of different dose levels and regimens of EXC 001 to~     improve the appearance of scars in subjects undergoing an elective abdominoplasty. The study~     will also evaluate the safety and tolerability of EXC 001.~   "
192978|NCT01038284|"~     Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which~     treatment has evolved in the last few years, improving quality of life. However, adherence to~     treatment has not been assessed in such patients. The investigators developed a collaborative~     care model involving clinical pharmacists in PAH. The objective of this work is to evaluate~     the impact of such model of care on medication errors and adverse events, quality of life and~     clinical criteria.~      This randomized multicentre controlled study will include approximately 100 PAH patients~     (NYHA II to IV). After inclusion, patients will receive either collaborative care including~     consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will~     be followed during 18 months from the date of inclusion.~      The investigators hope to show the positive impact of a collaborative care model in PAH. More~     specifically, the investigators aim to show the interest of long-term patient education to~     improve patient safety related to drugs, but also their quality of life, and have preliminary~     data about usual clinical criteria.~   "
192979|NCT01038271|"~     The main purpose of this study is to compare two types of treatment-standard palliative care~     (which usually is given towards the end of life) and integrated palliative care (which is~     given soon after diagnosis) to see which is better for improving quality of life of~     participants with advanced non-small cell lung cancer. Palliative care is care that tries to~     lessen the symptoms of a disease. Although many people with advanced lung cancer receive~     palliative care or hospice toward the end of their disease, the entire course of their~     disease is often complicated by physical and emotional difficulties. Palliative care may be~     useful when it is started soon after diagnosis.~   "
192980|NCT01038258|"~     A PET scan drop less than 20% in SUVs or below a certain absolute SUV value after the first~     course of neoadjuvant chemotherapy can predict pathological response, and could in the future~     lead to an early surgical intervention.~   "
192981|NCT01038245|"~     Background:~      - Central nicotinic acetylcholine receptors (nAChRs) are primary targets for the action of~     nicotine. In addition to being involved in tobacco dependence, they are also involved in a~     variety of brain disorders, including Alzheimer's and Parkinson's diseases. Researchers are~     interested in developing better ways to study the action of nAChRs to improve treatments for~     smoking cessation and other problems affected by these receptors. These new study methods may~     involve different approaches to positron emission tomography (PET) scanning, which can show~     brain activity related to nAChRs.~      Objectives:~      - To evaluate appropriate and useful doses of radiotracers used in PET scanning of nAChRs in~     the brains of nonsmokers/former smokers, light smokers, and heavy smokers.~      Eligibility:~      - Individuals between 18 and 50 years of age who fall into one of the following groups: (1)~     nonsmokers or former smokers who have not smoked for the past 2 years, (2) light/situational~     smokers, or (3) heavy smokers (at least 15 cigarettes/day for the past 2 years).~      Design:~        -  Each participant will undergo up to three PET studies, given approximately1 month apart.~          Each study will take approximately 8 hours to complete.~        -  Participants will provide urine and breath samples before the study and at the start of~          the study, which will be tested for chemicals that may interfere with the study.~        -  Depending on the study, some of the smoking participants may receive a nicotine patch to~          wear during the PET scan.~        -  On the day of the study, participants will receive a dose of a radiotracer (a drug used~          in PET scanning) given either as a single injection or as an injection followed by a~          continuous infusion, and will have a series of PET scans over the next 7 hours and~          provide blood samples during that time.~        -  Participants will return for a follow-up visit 1 month after the end of the study.~   "
192982|NCT01038232|"~     Background:~      - People who are in treatment for substance abuse often feel distress during the withdrawal~     period and afterward. Some individuals feel distress more acutely than others, and this~     distress has been linked to poor treatment outcomes and increased risk of relapse in smokers,~     alcoholics, and cocaine- and heroin-dependent individuals. More research is needed on the~     effects of distress on the brain, particularly in individuals who are seeking treatment for~     substance abuse. Researchers are interested in using functional magnetic resonance imaging~     (fMRI) scanning to study distress tolerance in both substance users seeking treatment and~     healthy non-drug-using volunteers.~      Objectives:~      - To use functional magnetic resonance imaging to study the effectiveness of a distress~     tolerance assessment.~      Eligibility:~      - Individuals between 18 and 50 years of age who are either cocaine dependent or healthy~     non-drug-using volunteers.~      Design:~        -  This study involves an initial screening visit and a scanning visit, with four followup~          visits.~        -  Participants will be screened with a medical history and physical examination, as well~          as blood samples and questionnaires about mood and past and current drug use.~        -  Participants will have a structural MRI scan of the brain to provide a baseline reading~          for comparison. Participants will then have an fMRI scanning session, which will include~          both the distress tolerance assessment and relevant control tasks. Heart rate, blood~          pressure, and other physical reactions will be monitored throughout the scan.~          Participants will also provide blood and saliva samples to measure stress hormone~          levels.~        -  Participants will be eligible to have followup assessments with fMRI scanning 1, 3, 6,~          and 12 months after the scanning visit.~   "
192983|NCT01038219|"~     Background: Fever is a widespread symptom in many diseases. Therefore, its value and~     diagnostic importance are well known. Fever in children is one of the common reasons for a~     visit to the pediatrician. Also, taking temperature is a very simple action and accessible to~     the general public.~      Temperature is measured in various parts of the body by using medical equipment. The type of~     method and thermometer varies according to the patient's age but often temperature is~     estimated by touch. Temperature measurement serves as a means for monitoring the patient's~     condition. For that reason, supervision of the body temperature is an important factor in the~     process of taking medical decisions.~      Study rationale: the parent is often asked if the child's temperature has been taken. The~     most frequent answer is: I didn't measure, but I felt that he has a temperature. The few~     studies carried out on this subject showed that many parents used touch to evaluate the~     child's body temperature, especially in infants.~      Some studies checked the reliability of parents to estimate the child's body temperature by~     touch only. To the best of our knowledge, the reliability of medical staff (nurses) to~     estimate the child's body temperature by touch has never been studied.~      The aim of the current study is to investigate whether parents and nurses correctly estimate~     the child's body temperature by touch, as compared to thermometer measurement during the~     pediatric unit's routine work.~   "
192984|NCT01038206|"~     The focus of this study will be to test the Familias Unidas Intervention program among~     Hispanic 8th graders in the Miami-Dade County Public School System. This study will~     contribute to the advancement of knowledge in both the scientific community and the Hispanic~     population in Miami-Dade County. It will shed light on whether and to what extent Familias~     Unidas is effective in preventing drug use and unsafe sexual behavior in Hispanic~     adolescents. To the scientific community, the investigators will disseminate our findings via~     peer-reviewed publications and presentations at scientific meetings.~      The design for the proposed study is a randomized controlled trial. This design is considered~     the gold standard design when evaluating the efficacy of two (or more) treatment~     conditions. Participants for this study will be 744 Hispanic 8th grade adolescents and their~     parents recruited from 24 randomly selected middle schools in Miami Dade County that meet the~     school inclusion/exclusion criteria. A total of 12 schools (for a total of 372 Hispanic~     adolescents and their parents) will be randomized to Familias Unidas and a total of 12~     schools (for a total of 372 Hispanic adolescents and their parents) will be randomized to the~     Community Practice.~   "
192985|NCT01038193|"~     This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid~     haemorrhage patients in neurosurgical units in Hong Kong.~   "
192986|NCT01038180|"~     This study examines possible risk factors with regard to complications following pacemaker~     implantation.~   "
192987|NCT01038167|"~     The purpose of this study is to evaluate the effect that telaprevir has on the~     pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is~     absorbed into the bloodstream, distributed in the body and eliminated from the body.~   "
193003|NCT01037959|"~     Patients with advanced cirrhosis have abnormal translocation of Gram-negative bacteria across~     the intestinal barrier and subsequent systemic inflammatory response. We hypothesized that~     this translocation may worsen the underlying liver disease. Thus, the aim of this trial was~     to assess the effects of the oral administration of norfloxacin (an antibiotic that~     suppresses intestinal Gram-negative bacteria) on the development of complications of~     cirrhosis.~   "
192988|NCT01038154|"~     The survival of esophageal cancer and stomach cancer (EGC) at 5 years is less than 30%.~     Pravastatin is a potent inhibitor of HMG-CoA reductase inhibitor that has shown increased~     survival in patients with advanced hepatocellular carcinoma. The objective is to evaluate the~     efficacy of treatment (increase in survival and recurrence-free period of the disease) with~     pravastatin in patients with advanced EGC. The investigators have designed a randomized,~     controlled and open. Advanced stage was considered for patients with T4 or N1 or M1 according~     to the TNM classification. It has been estimated sample size per treatment arm of 73 patients~     (146 patients in total). Randomization was done on a stratified by location (CE or CG). All~     patients receive hatitual treatment (surgery and / or chemotherapy and / or radiotherapy and~     / or palliative) for each of their clinical conditions. The experimental group will receive~     one tablet of 40 mg of pravastatin orally every 24 hours (breakfast) for 2 years. There will~     be a monthly monitoring of these patients for at least 2 years which includes an analytics.~     Every 2 months there will be an abdominal-pelvic CT scan to assess progression and treatment~     response.~   "
192989|NCT01038141|"~     The purpose of this study is to compare a new mini invasive surgical procedure (Recto Anal~     Repair) to the traditional Milligan-Morgan procedure in patients suffering from severe piles.~   "
192990|NCT01038128|"~     The primary objective of this 13-week clinical trial is to test the hypothesis that treatment~     with Memantine will significantly improve the symptoms of those suffering from either bulimia~     nervosa, purging type or suffering from body dysmorphic disorder.~   "
192991|NCT01038115|"~     The purpose of this study is to perform a prospective, randomised study investigating the~     safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation,~     or both together in the treatment of paroxysmal AF.~      The hypotheses for this study are (1) that cryothermal energy is as effective and safe as~     using radiofrequency energy in the treatment of paroxysmal AF and is associated with a better~     long term outcome, and (2) that use of both cryothermy and RF in combination is as effective~     and safe as using either radiofrequency energy or cryothermy alone and is associated with a~     better long term outcome.~   "
192992|NCT01038102|"~     The purpose of this study is to investigate whether substituting saturated fats with~     polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic~     variables in abdominally obese subjects~   "
192993|NCT01038089|"~     Observational studies have shown that consumption of grapes and grape products such as red~     wine is associated with reduced cardiovascular risk. The mechanisms accounting for this~     benefit remain incompletely understood. Resveratrol is a component of grapes and red wine~     that has favorable effects on endothelial function in diabetic and obese animals. Resveratrol~     is available to people over-the-counter in health food stores and the internet as a dietary~     supplement.~      The endothelium plays a central role in the control of blood vessel function. When healthy,~     the endothelium prevents vasospasm, blood clot formation, and the development of~     atherosclerosis. Endothelial function is abnormal in patients with diabetes mellitus and this~     abnormality contributes to the development of cardiovascular disease.~      The present pilot study is designed to test the hypothesis that resveratrol (90 mg/day and~     270 mg/day for one week each) will have favorable effects on endothelial function in patients~     with diabetes mellitus.~   "
192994|NCT01038076|"~     This study will examine whether a computerized, self-administered assessment of patient~     medication adherence and health behaviors, plus support for adherence, improves the ability~     of clinicians to identify adherence problems and leads to better adherence.~   "
192995|NCT01038063|"~     A community-based, open-label, cluster-randomised longitudinal study in which children are~     randomized according to village health worker catchment areas comparing the safety and~     effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period~     in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine~     (DHA-PPQ).~   "
192996|NCT01038050|"~     Type 2 diabetes is associated with a markedly increased risk for atherosclerotic coronary~     arteries and cerebrovascular diseases. The major cause of death in diabetic patients is~     cardiovascular disease in the world including Taiwan. Atherosclerosis is a progressive~     disease characterized by the response of the vessel wall to chronic, multifactorial injury,~     which leads ultimately to the formation of atheromatous or fibrous plaques. Endothelial~     dysfunction is thought to be the initial stage of atherosclerosis. Endothelial dysfunction~     leads to impaired control of vascular tone, a decreased in the release of anti-inflammatory~     factors and reduced availability of nitric oxide. Endothelial dysfunction portends diabetic~     vasculopathy. The loss of intact endothelial integrity and function sets in motion a cascade~     of serial events that lead to atherosclerosis and cardiovascular complications.~      The standard extracts of G. biloba leaves [G. biloba extract (GBE)] are now demonstrated the~     cardiovascular, cerebrovascular and neuroprotective effects. The mixture of biologically~     active ingredients in GBE accounts for the pleiotropic effects, including antioxidant~     effects, inhibition of platelet aggregation and thromboxane B2 production, vasodilation and~     modulation of cholesterol metabolism. Clinically, GBE was widely used in management of~     vertigo、dementia and improving peripheral circulation. In our previous study, ginkgo biloba~     extract inhibits tumor necrosis factor-alpha-induced reactive oxygen species generation,~     transcription factor activation, and cell adhesion molecule expression in human aortic~     endothelial cells. In addition, the similar benefit of prevention atherosclerosis was also~     found in animal study.~      Heme oxygenase-1 (HO-1) is a factor associated with higher risk of developing some vascular~     disease and also a rate-limiting enzyme in heme degradation, leading to the generation of~     free iron, biliverdin, and carbon monoxide (CO). CO exerts potent antiproliferative and~     anti-inflammatory effects in the vascular walls, thereby influencing neointimal formation~     after vascular injury. In addition, biliverdin is subsequently metabolized to bilirubin by~     the enzyme biliverdin reductase. Therefore, induction of HO-1 elicits potent~     anti-inflammatory, antiproliferative, antithrombotic, and antioxidant effects in the~     circulation via the generation of CO and bilirubin. Interestingly, recent study found that a~     long guanidine thymidine dinucleotide repeat [(GT) n≧ 30] in the HO-1 promotor, which is~     linked to impaired inducibility, is associated with a higher frequency of vascular access~     failure.~      In the present study, we will investigate the effect of GBE on recovering endothelial~     dysfunction and inflammation in diabetic patients with stable coronary artery disease. In~     particularly, we intend to determine whether the GBE modulates the HO-1 expression and~     investigate whose genotyping including some candidate gene about atherosclerosis and~     hypertension will have most therapeutic effect of GBE.~   "
192997|NCT01038037|"~     The purpose of this study is to determine whether the addition of panitumumab to standard~     chemotherapy in first-line treatment of advanced Non Small Cell Lung Cancer improves the~     treatment outcome. Patients are selected based on triple mutational status.~   "
192998|NCT01038024|"~     The purpose of this study is to evaluate the basis for the reported good effects of~     antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage~     which is expected to decrease with antioxidant administration and therefore decrease the risk~     of cancer.~   "
192999|NCT01038011|"~     Randomized, controlled, double-blind, multicenter phase II study comparing risedronate 35mg~     (ActonelR 35mg weekly tablet) versus placebo in patients with active ankylosing spondylitis~     (AS) treated with standard first and second-line therapies.~      Primary efficacy endpoint: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The~     time schedule for performing the BASDAI was at screening, upon inclusion (T0), then after 3,~     6 and 12 months or at the time of premature withdrawal in case of drop-out.~      secondary endpoints:~        -  Clinical endpoints: The secondary efficacy measures were the following: Bath Ankylosing~          Spondylitis Functional Index (BASFI) , Bath Ankylosing Spondylitis Metrology Index~          (BASMI), ASAS (Assessments in Ankylosing Spondylitis) Working Group core set of domains,~          Spinal pain VAS, ESR, CRP and the percentage of patients achieving 20% or greater~          decrease in each of these parameters. These parameters were determined at T0, T3, T6,~          T12 or at the time of premature withdrawal in case of drop-out. The spinal pain assessed~          by VAS was also done at screening.~        -  DEXA: Dual Energy X-Ray-Absorptiometry (DEXA) measurements were performed in all~          patients upon inclusion (T0) and at the end of the study (T12).~        -  Biochemical markers: selected biochemical markers of bone metabolism were measured at~          T0, T3, T6 and T12 or at the time of premature withdrawal in case of drop-out using~          commercially available kits. Bone formation was assessed by serum bone-specific alkaline~          phosphatase (BAP) and osteocalcin (OC) levels using commercially available kits. Bone~          resorption was assessed in serum by the C-terminal telopeptide of type I collagen~          degradation (Crosslaps R) and urinary N-terminal telopeptide of type I collagen~          degradation (Osteomark R).~        -  Trial with medicinal product~   "
193000|NCT01037998|"~     Iressa [epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI)] has been reported to~     activity against Non-small-cell Lung Cancer (NSCLC) failed previous chemotherapy. UFUR was~     found to have anti-angiogenesis effect when long term treatment was given. Combination of~     EGFR-TKI and anti-angiogenesis agents is a novel treatment.~   "
193001|NCT01037985|"~     The study will investigate the ability of EXC 001 to improve the appearance of scars in~     subjects undergoing an elective abdominoplasty. The study will also evaluate the safety and~     tolerability of EXC 001.~   "
193153|NCT01035333|"~     The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping~     patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication~     will be added to the usual standard of care which includes education regarding diet and~     exercise and monthly meetings with a registered dietician.~   "
193004|NCT01037946|"~     This project aims to support adults in HIV-affected families in order to improve their~     well-being. UCLA's Center for Community Health (CCH), in collaboration with the Thai Ministry~     of Public Health, Bureau of Epidemiology, will implement the Family-to-Family (F2F)~     intervention in order to improve the social, behavioral and mental health outcomes for~     families affected by HIV.~      In Phase 1, the investigators pilot tested the current intervention contents and activities~     by collecting qualitative data from HIV+ families in the four district hospitals in Chiang~     Rai and Nakohn Ratchasima provinces selected for the proposed study. The findings from Phase~     was used to develop intervention content, as well as the format and style of the intervention~     for Phase 2. In addition, the findings from Phase 1 was used to finalize the assessment~     measures the investigators will use in Phase 2.~      In Phase 2, 410 families with HIV+ parents from 4 district hospitals in Chiang Rai & Nakhon~     Ratchasima Provinces will be recruited to an intervention to benefit their school-aged~     children aged 6-17 years. At their clinical care site,the investigators randomly assigned~     families to either: 1) F2F, a psychoeducational intervention for HIV+ parents and family~     caregivers; or 2) a Standard Care condition. The impact of the F2F intervention will be~     monitored over 24 months.~   "
193005|NCT01037933|"~     Primary aims: To compare changes in (a) symptoms related to cancer and chemotherapy, (b) a~     marker of immune function (salivary immunoglobulin A), and (c) a hormonal marker of emotional~     stress (salivary cortisol) between two groups of patients who view a humorous or non-humorous~     DVD.~      Secondary aim: To describe the perception of patients, caregivers, and nurses regarding the~     overall intervention experience.~   "
193006|NCT01037920|"~     The objective of the project is a test-of-concept of an intervention to reduce the effects of~     the perception of discrimination on the care of patients with chronic illness. Perception of~     discrimination manifests itself as stereotype threat. We hypothesize that stereotype threat~     impairs communication between minority patients and their physicians because of increased~     stress and diminished trust, resulting in interactions that are less successful at enhancing~     patient self-efficacy, in turn resulting in lower rates of adherence with anti-hypertensive~     medication.~      The intervention is a self-affirmation exercise performed prior to a patient-physician visit.~     A similar intervention has been shown to reduce the racial gap in academic performance in~     middle school classrooms.~      We will explore the mechanistic effects of the intervention by analysis of audiotapes of~     patient-provider visits following the intervention. We will measure the effect of the~     intervention on minority hypertensive patients' adherence with antihypertensive medication~     and blood pressure.~      We will enroll 200 African American and Latino patients with hypertension and randomize 100~     patients to perform the exercise and 100 patients to perform a null control exercise before~     the visit. We will assess change in patient's adherence with antihypertensive medications and~     in blood pressure over the six months following the index visit. In order to better~     understand the effects of the intervention we will measure subject's mood following the~     exercise, and self-reported stress levels, trust in the physician, and medication~     self-efficacy following the visit. We will also assess the quality of the patient-provider~     interaction from detailed analysis of audiotapes and from patient questionnaires. Following a~     subsequent patient-physician visit, we will conduct telephone interviews with patients to~     assess for persistence of any effects of the intervention.~   "
193007|NCT01037907|"~     To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing~     remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing~     lesions after 24 weeks of treatment with BGC20-0134.~   "
193008|NCT01037894|"~     The purpose is to establish whether acupuncture in addition to conventional rehabilitation~     programme can improve the functional outcome and quality of life of surgical patients with~     haemorrhagic stroke, as compared to conventional rehabilitation programme alone.~   "
193009|NCT01037881|"~     This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with~     vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment~     regimen in mild to moderate atopic dermatitis patients.~   "
193010|NCT01037868|"~     Background:~      There is abundant evidence that rates of comorbidity between substance use and depression are~     high (1, 2) and the risk of poor outcome is higher among individuals with the dual disorder~     compared with those with a single disorder (3, 4, 5, 6). Previous research has shown that~     about 50% of persons studied with severe mental illness and past substance abuse are likely~     to have a recurrence of substance abuse within 1 year of discharge from treatment (7).~      There is therefore a clear clinical challenge in treating patients with the dual disorder~     which may calls for further research and the possible introduction of new and innovative~     strategies including the use of mobile phone technology to provide increased support for~     patients with the dual diagnosis.~      There are established research evidence for using Short Message Service (SMS) text messages~     to remind patients of scheduled medical appointments (8,9,10,12, 13), coordinate medical~     staff,(14) deliver medical test results,(15,16) , promote smoking cessation ( 17), improve~     self-monitoring among the youth with type 1 diabetes( 18), promote weight loss among obese~     subjects (19 ) and monitor patient side effects following treatment(20).~      Relevance of the research:~      To date, after an extensive review of the literature using MEDLINE, Pub Med, ERIC, Web of~     Science, Science Direct and PsycINFO, no studies was found on the use of SMS text messages as~     an intervention to address abstinence amongst alcohol dependent subjects who are co-morbid~     for a depressive disorder. Thus, the investigators seek to determine if text messaging is a~     useful and effective strategy to help maintain abstinence, improve adherence with medication~     and ultimately promote mental stability in depressed patients discharged from an in-patient~     dual diagnosis programme. The investigators hypothesize that, daily supportive/reminder SMS~     text messages to depressed patients discharged from an in-patient dual diagnosis programme~     would increase alcohol abstinence rates , improve medication adherence rates and improve the~     overall mental well being of patients compared with those receiving treatment as usual.~   "
193011|NCT01037855|"~     This is an observational study of safety and occurrence of influenza-like illness following~     administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit~     vaccine in subjects 6 months of age and older.~   "
193012|NCT01037842|"~     We performed a prospective, randomized, multicenter trial to assess the efficacy and safety~     of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who~     show inadequate glycemic control with metformin monotherapy. Subjects with HbA1c >7.0% after~     an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus~     mitiglinide (Met+Mit) or metformin plus placebo (Met).~   "
193013|NCT01037829|"~     The primary objective of this observational, comparative safety study is to evaluate the~     safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off~     spring, followed for up to 3 months of age as compared to pregnant women who have not~     received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at~     investigative sites within the Netherlands, Italy, and Argentina.~   "
193014|NCT01037816|"~     The objective of this study is assess the efficacy and safety of single and multiple~     applications of the FS-67 patch in the treatment of ankle sprain in pediatric population~     (ages 13-17).~   "
193015|NCT01037803|"~     Does sublingual SDF-imaging results correlate with other haemodynamic parameters measured~     perioperatively and with postoperative morbidity/complications.~   "
193016|NCT01037790|"~     RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in~     treating patients with refractory solid tumors.~   "
193017|NCT01037777|"~     The spinocerebellar ataxias (SCAs) are a clinically and genetically heterogeneous group of~     autosomal dominantly inherited progressive ataxia disorders. It is estimated that there are~     30,000 individuals in the European Community that directly descend from individuals affected~     by a SCA disorder and thus carry a 50% risk of having inherited an SCA mutation. These at~     risk individuals provide a unique research opportunity to prospectively study the~     presymptomatic phase of SCA disorders and to identify the earliest and most sensitive~     clinical signs and biological markers that herald the onset of the illness. This information~     is of critical importance for the development of future therapeutic interventions aimed at~     postponing the clinical onset of ataxia.~      We therefore propose to perform a prospective observational study of individuals at risk for~     the most common SCA disorders, SCA1, SCA2, SCA3 and SCA6 (RISCA). It is our aim to answer the~     following questions: (1) What is the incidence of disease manifestation in mutation carriers?~     (2) Which clinical signs precede the onset of manifest ataxia in SCA1, SCA2, SCA3 and SCA6?~     (3) What are the prevalence and incidence of preceding signs? (4) Are the prevalence and~     incidence of preceding signs affected by genotype, gender, age, estimated time until disease~     manifestation and repeat length? (5) Does the presence of certain preceding signs predict the~     manifestation of ataxia ? (6) Are there MRI alterations that precede the onset of ataxia? It~     is planned to enroll 480 study participants and to follow them at regular intervals over six~     years. At each visit, study participants are asked in a structured interview for a number of~     predefined clinical signs that potentially precede the onset of ataxia. In addition, the~     following self-assessment scales will be applied: Pittsburgh Sleep Quality Index (PSQI),~     Diagnostic Criteria for Restless Legs Syndrome, Patient´s Health Questionnaire (PHQ-9). All~     study participants will undergo a physical examination including the Scale for the Assessment~     and Rating of Ataxia (SARA). Study participants will further perform the SCA Functional~     Composite (SCA-FC) which is a comprehensive measure of functional capacity based on results~     in quantitative tests related to gait (8m timed walk), speech (PATA rate) and hand function~     (9 hole pegboard). In a subset of study participants, we will record eye movements and obtain~     volumetric MRIs. The study will also be used to collect and store blood and urine samples for~     proteomic and gene expression studies.~      RISCA is conducted by the Ataxia Study Group (ASG). It relies on the network structure~     created by the EUROSCA project.~   "
193018|NCT01037764|"~     [Study Objectives]~        -  To evaluate the efficacy of allogeneic hematopoietic cell transplantation (HCT) in~          patients with acute lymphoblastic leukemia (ALL) in the first or second complete~          remission (CR). The efficacy of the treatment will be measured in terms of the frequency~          of relapse and duration of remission (the primary endpoints).~        -  The secondary end points of the study include; engraftment, donor chimerism, secondary~          graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery,~          infections, transplantation-related mortality, leukemia free survival, and overall~          survival.~   "
193019|NCT01037751|"~     Objectives:~      The objective of this study is to delineate and measure the symptom burden experienced by~     patients with ovarian cancer.~      The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson~     Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the~     impact of these symptoms on daily functioning in patients with ovarian cancers.~      The Secondary Aims are:~      To develop a detailed description of symptom severity and interference with daily activities~     experienced by patients with ovarian cancer; To assess the impact of symptom severity on~     standard functioning and quality of life (QOL) measures, including Eastern Cooperative~     Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary~     (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the~     qualitative symptom burden of patients with ovarian cancer receiving various treatments.~   "
193020|NCT01037738|"~     Abstract~      Background~      Pro-inflammatory cytokines play a pivotal role in osteoarthritis, as well as in bone tunnel~     widening after ACL reconstructive surgery. A new treatment option is to administer autologous~     conditioned serum (ACS) containing endogenous anti-inflammatory cytokines including IL-1Ra~     and growth factors (IGF-1, PDGF and TGF-ß1, among others) in the liquid blood phase.~      Objective The purpose of this trial was to establish whether the osteoclastic effect could be~     affected by intra-articular application of ACS, thus resulting in a potential decrease of~     knee laxity and leading to a better postoperative outcome.~      Methods In a prospective, randomized, double-blinded, placebo-controlled trial with two~     parallel groups, 62 patients were treated. Bone tunnel width was measured by CT scans, while~     clinical efficacy was assessed by patient-administered outcome instruments (WOMAC, IKDC 2000)~     up to one year following the ACL reconstruction in patients receiving either ACS (Group A) or~     placebo (Group B). The investigators compared the levels and dynamics of IL-1b concentrations~     in the synovial liquid and examined the correlation between the levels of IL-1b at three~     different post-operative points.~      Level of evidence Therapeutic study, Level 1 (randomized controlled trial [significant~     differences and narrow confidence intervals])~   "
193021|NCT01037725|"~     The main purpose of this study is to assess the safety and tolerability of AZD5847 after~     receiving oral doses on a single day (Part A) or after receiving a single oral dose in two~     periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also~     be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its~     metabolites in blood and urine.~   "
193022|NCT01037712|"~     The infection with cytomegalovirus (CMV) is the first cause of congenital neurological~     handicap of infectious origin. It is probable that the neonatal viral load is correlated with~     becoming of infected new-born babies. Among the active antiviral treatments against CMV,~     valacyclovir is the only whose fetal and maternal tolerance was evaluated during the~     pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to~     evaluate it in a study against placebo. Decrease the fetal viral load could make possible to~     decrease symptomatology neonatal in a group of infected fetuses.~   "
193023|NCT01037699|"~     To analyse the impact on cycle outcome of LH supplementation in ovarian stimulation~     controlled with a GnRH antagonist in two ages groups: patients upto 35 years old, and~     patients aged between 36 and 39 years old.~   "
193024|NCT01037686|"~     The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and~     stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during~     cognitive task performance or at rest.~   "
193045|NCT01037400|"~     This study will examine the magnitude and time course of changes in circulating (serum and~     plasma) biomarker concentrations associated with musculoskeletal injury created by total knee~     replacement surgery. The sensitivity to injury will be characterized by the changes in mean~     serum concentration before and after surgery. Specificity for the injured state will be~     evaluated comparing the baseline to peak change (injury response) with the pre-surgery to~     follow-up baseline fluctuation (i.e. measurement noise).~   "
193154|NCT01035320|"~     The purpose of this study is compare the effects of simvastatin+ezetimibe with those of~     simvastatin alone on platelet activity, platelet-leukocyte interactions and inflammatory~     variables in diabetic patients with or without impaired renal function.~   "
193025|NCT01037673|"~     Objective:~      A randomized clinical trial in order to evaluate the efficacy of structured eccentric~     exercises tutored by a physical therapist (PT) for patients with subacromial impingement.~      Hypothesis:~      H1 The exercises has a satisfactory effect and the need of an arthroscopic subacromial~     decompression can be reconsidered.~      H0 No difference between the two exercises (experimental and active control) and the patients~     still need surgery~      Further the study objective is to evaluate predictors for a positive or negative treatment~     response after three months of rehabilitation as well as after 12 months.~      Method:~      Patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are~     offered a three month rehabilitation program during the waiting time for surgery which is~     approximately 4-6 months. All patients must have tried conservative treatments for at least 6~     months in primary care with unsatisfactory results. The patients will be randomized to either~     the structured eccentric exercises tutored by a physical therapist or control exercises with~     general movements for the neck and shoulders. All patients has an equal number of sessions~     with the PT to offer similar attention. After three months the following key-question has to~     be answered: due to your current experience of your shoulder problems do you still need this~     surgical intervention? A blinded orthopedic surgeon evaluates the following outcomes at~     baseline and after three and twelve months. Primary outcomes: Constant-Murley shoulder~     assessment, Disabilities of the Arm Shoulder and Hans and different aspects of pain.~     Secondary outcomes; EQ-5D, sick-leave and return to work. All patients are evaluated with a~     diagnostic ultrasound in order to reveal the condition of the rotator cuff. Also long-term~     results in those who go thorough with the surgery and those who decline will be assessed~     after 12 months.~      Importance of the study results:~      Since there is no consensus about which intervention that should be preferred for patients~     with subacromial impingement the results of the current study is warranted. If this exercise~     program is successful it can be implemented into clinical practice. Further, clinical~     characteristics of patients that really need an arthroscopic subacromial decompression can be~     identified.~   "
193026|NCT01037660|"~     Eating a diet high in fat contributes to the development of atherosclerosis (hardening of the~     arteries). Acute fat consumption increases levels of fat in the blood and temporarily reduces~     the ability of blood vessel to dilate (open up to carry additional blood). A similar response~     is observed during infusion of Intra-Lipid (a fat emulsion used for intravenous nutrition).~     The present study is designed to help us understand the effects of a fat load on blood vessel~     function. We will measure arterial dilation using non-invasive techniques before and at the~     end of a 5-hour infusion of Intra-Lipid in healthy subjects. Subjects will then take the~     approved drug metformin for two weeks and return for repeat studies of endothelial function~     with Intra-Lipid infusion. We expect that metformin will help preserve the normal function of~     blood vessels during a fat load. This study will help us understand how fat affects blood~     vessels and therefore will advance our knowledge of the development of atherosclerosis and~     potentially lead to improved methods to prevent and treat heart disease.~   "
193027|NCT01037647|"~     Type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for~     coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of~     lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence~     suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG)~     is a central pathophysiological feature of the lipid and lipoprotein abnormalities in~     diabetic dyslipidemia.~      The objective of this study was to investigate VLDL-TG kinetics and aspects of peripheral~     VLDL-TG metabolism, i.e. to what extent VLDL-TG associated fatty acids (FA) are oxidized or~     deposited in regional adipose tissue, in subjects with type 2 diabetes and healthy controls~     in the postabsorptive state and during acute hyperinsulinemia using ex-vivo labeled VLDL-TG~     tracers.~   "
193028|NCT01037634|"~     Currently, there is no standard treatment for influenza with related lower respiratory tract~     infection (LRTI) in children younger than one year of age, even though influenza related LRTI~     is a potentially fatal illness in these children. This study will test a medicine for~     influenza in children younger than one year of age to see if it is safe and effective.~   "
193029|NCT01037621|"~     This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and~     herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching~     placebo. After receiving the initial therapy for eight weeks, the participants will cross~     over to the alternate therapy for an additional eight weeks. Each treatment period will be~     separated by a two-week period of daily placebo. The hypothesis is that treatment with~     valacyclovir will result in a significant reduction in serum levels of hepatitis C virus~     ribonucleic acid.~   "
193030|NCT01037608|"~     Background:~        -  The therapeutic modalities of cannabis have received more research attention recently~          with the discovery of its ability to stimulate appetite and to provide pain and nausea~          relief in patients with AIDS, cancer, and multiple sclerosis, among other diseases.~          Sativex(Registered Trademark), an experimental drug derived from the marijuana plant,~          contains tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which affect brain~          activity. Sativex(Registered Trademark) is being tested to determine how and to what~          extent it affects brain activity.~        -  Functional magnetic resonance imaging (fMRI) uses magnetic waves to study brain~          activity. Researchers are interested in using fMRI to study how Sativex(Registered~          Trademark) affects regional brain activity, including thinking abilities and behavior.~      Objectives:~        -  To study changes in regional brain activity produced by Sativex(Registered Trademark)~          compared with THC and placebo.~        -  To determine how Sativex(Registered Trademark) is processed by the body.~      Eligibility:~      - Individuals between 18 and 45 years of age who are either current users of cannabis (less~     than daily) or healthy volunteers who do not use cannabis.~      Design:~        -  The study will involve one training session and five testing sessions on separate days.~        -  At every session, subjects will receive either THC or placebo capsules and either~          Sativex(Registered Trademark) or placebo spray.~        -  Participants will complete a training session in a mock fMRI scanner to adapt to the~          fMRI scanning environment. In the training session, participants will practice the tests~          that will track thinking ability, attention, working memory, and other cognitive tasks.~        -  Participants will have five fMRI scanning sessions with the tests they have practiced~          previously, and will provide blood, urine, and saliva samples as required by the~          researchers. Participants will be discharged approximately 12 hours after they arrive~          for the study sessions....~   "
193031|NCT01037595|"~     The purpose of this study is to see whether turmeric can be effective in treatment of~     pruritus in hemodialysis patients.~   "
193032|NCT01037582|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability and bioavailability (exploring absorption of drug in body) of NN9924 in healthy~     male subjects.~   "
193033|NCT01037569|"~     Background:~        -  Children who enter the foster care system are all too often exposed to illicit drugs in~          the home. Children from these homes, known as drug endangered children, are not~          routinely tested for harmful substances. Any short- and long-term physical or~          developmental problems they may experience as a result of this exposure often go~          undetected and untreated.~        -  Children who are placed into protective custody are not always screened by physicians or~          nurse practitioners. Although drug-endangered children under 18 years of age~          automatically receive a urine toxicology screen to determine the types and levels of~          illicit drugs in their systems, this procedure has difficulties and limitations that may~          affect the quality of the data. Researchers are interested in developing more effective~          methods of analyzing the presence or absence of illicit environmental drug exposure in~          children.~      Objectives:~      - To determine the most effective method of identifying long-term illicit stimulant drug~     exposure in drug-endangered children.~      Eligibility:~      - Children under 18 years of age who are being placed into protective custody after having~     been found in a home where drugs are manufactured, used, or sold.~      Design:~        -  Researchers will gain verbal consent for the procedure for children who are 7 years of~          age or older. Children younger than 7 years of age will not be required to give verbal~          consent for sample collection.~        -  Researchers will collect standard urine samples for toxicological screening. Part of the~          sample will be sent to the National Institute on Drug Abuse for evaluation; the rest~          will remain with the local authority.~        -  In addition to this standard procedure, researchers will collect a hair sample by~          cutting a small amount of hair from the crown of the head as close to the root as~          possible (and not pulling any hair out of the child's head).~        -  Researchers will also use an oral swab to collect a saliva sample from the inside cheek~          of each child.~        -  No clinical care will be provided under this protocol....~   "
193034|NCT01037556|"~     The current understanding of PR104 justifies the evaluation of PR104 in subjects with~     relapsed/refractory AML and ALL. These include:~        -  Hypoxia. Leukemic bone marrow is likely to demonstrate a level of hypoxia sufficient to~          activate PR104 to its active metabolites PR104H and PR104M.~        -  Myelotoxicity as the primary toxicity at MTD. In prior clinical studies in subjects with~          solid tumors PR104 has demonstrated myelotoxicity as the primary toxicity. This~          observation suggests that PR104 will exert a similar effect on leukemic cells.~        -  AKR1C3. AML has been reported to exhibit high levels of AKR1C3 which should lead to~          selective activation of PR104 within both hypoxic and oxic leukemic cells.~        -  Preclinical data. PR104 has demonstrated impressive activity in an initial study using~          primary human ALL in a mouse model.~      The initial dose finding phase of the study will provide estimates of the activity and~     toxicity of PR104 in subjects with refractory/relapsed AML, and determine the optimal~     individualized dose to give each subject based on his/her covariates (prior CR duration,~     prior number of salvage therapies, age). Once a potentially beneficial dose has been~     determined, an expanded cohort of subjects with AML or ALL will receive PR104 at a uniform~     dose. This information will prove valuable in defining the future clinical development of~     PR104, and in determining if PR104 has sufficient activity and acceptable safety in AML to~     warrant future phase II or phase III studies in this indication.~      Primary objectives~        -  Determine the toxicities and recommended dose of PR104 when administered IV to subjects~          with relapsed/refractory AML and ALL.~      Secondary objectives~        -  Evaluate the pharmacokinetics (PK) of PR104 and a series of PR104 metabolites~        -  Evaluate any anti-tumor effects of PR104~        -  Evaluate the expression of AKR1C3 in bone marrow and leukemic cells~        -  Evaluate potential biomarkers of hypoxia~   "
193035|NCT01037543|"~     Study Design~        -  Randomized, double-blind, placebo-controlled, escalating single-dose design.~        -  Six ascending dose cohorts~        -  In each cohorts, subjects will be randomized to receive a single dose of HM10460A,~          placebo (negative control), or Neulasta® (positive control).~        -  Primary Objective~        -  to assess the safety and tolerability of single escalating subcutaneous doses of~          HM10460A in healthy adult Japanese and Caucasian subjects.~   "
193036|NCT01037530|"~     The investigators are conducting a randomised controlled trial to investigate the clinical~     and cost effectiveness of Ramipril which is an anti-hypertensive medication in patients with~     intermittent claudication. The investigators aim to recruit 78 participants in total. The~     investigators will randomise the 78 participants into two groups: Ramipril group with 39~     participants and Placebo group with 39 participants. The investigators will measure~     Ramipril's effect on walking by doing a simple treadmill test and measuring the maximum~     walking distance the participant can walk. The investigators also want to examine Ramipril's~     effect on arterial function, cardiovascular prognosis, quality of life and cost~     effectiveness.~   "
193037|NCT01037517|"~     Poor mobilization of hematopoietic progenitors needed to support autologous transplantation~     is a serious clinical problem. We are investigating the role of plerixafor administered in an~     at risk population to augment successful stem cell collection.~      OBJECTIVES~      To determine if plerixafor when administered on the day prior to planned autologous~     collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L~     will:~        -  increase the number of patients successfully collected in one day~        -  increase the number of patients successfully mobilized on first collection attempt~        -  is cost neutral within a Canadian setting~   "
193038|NCT01037504|"~     The aim of the study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male~     and female subjects~   "
193039|NCT01037491|"~     Clopidogrel causes significantly less peptic ulcer disease (PUD) and ulcer bleeding than~     low-dose aspirin in general population. However, clopidogrel is not safe enough for~     gastrointestinal (GI) mucosa in patients who had past history of aspirin-associated ulcer or~     ulcer bleeding. Aspirin plus proton pump inhibitor (PPI) is superior to clopidogrel alone in~     preventing recurrent ulcer bleeding in these high risk patients.~      This study is to compare the ulcer healing rate and ulcer bleeding at 12 weeks in patients~     with aspirin-associated PUD when they take PPI (rabeprazole 20 mg/day) to treat their PUD and~     simultaneously take aspirin or clopidogrel for their cardiovascular (CV) prevention. Two~     hundred patients will be randomly assigned rabeprazole (20 mg/day) plus aspirin (100 mg/day)~     or rabeprazole (20 mg/day) plus clopidogrel (75 mg/day) for 12 weeks. The primary end point~     is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer~     bleeding within 12 weeks.~      If rabeprazole plus aspirin in not inferior to rabeprazole plus clopidogrel in the incidence~     of ulcer healing and ulcer bleeding in the healing phase,PPI plus aspirin rather than PPI~     plus clopidogrel will be recommended during acute ulcer healing in patients who need~     antiplatelet therapy for their CV prevention.~   "
193040|NCT01037478|"~     The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe~     in the treatment of relapsed or refractory Hodgkin's Lymphoma.~   "
193041|NCT01037465|"~     The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm~     and thrombosis by producing nitric oxide and other regulatory substances. In patients with~     atherosclerosis, endothelial function is impaired. Excess production of reactive oxygen~     species (free radicals) contribute to endothelial dysfunction in atherosclerosis, and some~     prior studies have shown a beneficial effect of antioxidant treatment on endothelial function~     in patients with coronary artery disease. On the other hand, reactive oxygen species may be~     required for normal endothelial function and antioxidant supplements failed to show a benefit~     in large clinical trials. The effect of antioxidant treatment on endothelial function in~     healthy subjects is unknown. The present study will test the hypothesis that scavenging~     reactive species might reduce endothelium-dependent vasodilation in healthy subjects.~      The study is a randomized, double-blind, placebo-controlled crossover study. Participants~     will receive 2.4 grams of oral NAC or similar-appearing placebo during the first visit, and~     then will cross over to the alternative treatment (NAC or placebo) for the second and final~     visit. We will examine endothelial function before and after treatment on each visit.~   "
193042|NCT01037452|"~     This study will investigate the safety and efficacy of an antacid/Lansoprazole combination~     product for the relief of heartburn after consuming a heartburn-inducing meal.~   "
193043|NCT01037426|"~     The purpose of this study is to document the number of falls and fractures in Sinus Node~     Disease (SND) patients.~   "
193044|NCT01037413|"~     The study will investigate the ability of EXC 001 to improve the appearance of scars in~     subjects undergoing revision of scars resulting from prior breast surgery. The study will~     also evaluate the safety and tolerability of EXC 001 and placebo.~   "
193058|NCT01037218|"~     Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the~     safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of~     PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).~   "
193046|NCT01037387|"~     Parallel, randomized and controlled clinical trial to evaluate the effect of 12 months of~     noninvasive mechanical ventilation versus conventional treatment in hypercapnic patients with~     stable COPD.~      Main objective: To evaluate the effect of 12 months of noninvasive ventilation on c-reactive~     protein concentration and daily physical activity in hypercapnic patients with stable COPD.~      Secondary objectives: To compare the plasmatic concentration of other inflammatory biomarkers~     between COPD patients with conventional treatment and wich noninvasive ventilation. To~     determine the response of breathlessness, health-related quality of life and lung function to~     noninvasive ventilation. To identify the COPD patients with a higher gasometric and clinic~     response to noninvasive ventilation.~   "
193047|NCT01037374|"~     The purpose of this study is to see if our experimental preoperative airway assessment form~     is a better indicator of difficult airway as compared to the anesthesia record that is~     presently used.~   "
193048|NCT01037361|"~     Background:~        -  Motor stereotypies are a movement disorder characterized by involuntary, repetitive, and~          rhythmic movements. These movements have a predictable pattern and seem purposeful, but~          they serve no obvious function, tend to be prolonged, and can be suppressed. Common~          examples of motor stereotypies include hand waving, head nodding, and body rocking.~        -  Researchers are interested in learning more about motor stereotypies. Many children with~          autism and other developmental disorders tend to exhibit these behaviors, but normal~          healthy children and even some adults have demonstrated motor stereotypies under certain~          conditions (including boredom and stress). More research is needed to determine the~          internal causes of and potential successful treatments for these behaviors.~      Objectives:~      - To use electroencephalography (EEG) to study cerebral activity related to stereotypies in~     children.~      Eligibility:~      - Children between 7 and 18 years of age who demonstrate stereotypy movements on a consistent~     basis (at least 10 times a day for at least 4 months).~      Design:~        -  The study will require two visits to the National Institutes of Health Clinical Center.~        -  First visit: Outpatient screening visit to determine the child s eligibility for the~          study, including questionnaires for parents/guardians and a medical assessment of the~          stereotypies.~        -  Second visit: Participating children will spend 1 day in a room at the NIH Clinical~          Center Pediatric Day Hospital. During the visit, participants will wear a portable EEG~          unit to measure brain activity. For the first hour of the visit, researchers will~          perform movement tests to study the brain activity related to normal movements. For the~          rest of the day, participants may play games, watch television or movies, read, or nap,~          while continuing to wear the EEG to monitor brain activity related to the stereotypic~          movements.~        -  Participants will receive a small amount of compensation for their time and~          participation.~   "
193049|NCT01037348|"~     This study is designed to provide efficacy and safety data in patients with choroidal~     neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing~     schedule. Eligible patients who have provided written agreement to take part in the study~     will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following~     eye examinations and tests at monthly clinic visits, the study doctor will repeat the~     injections on a monthly basis as required for an additional 11 months, in accordance with~     specified retreatment criteria.~      Patients will be in the study for approximately 12 months and will visit the hospital clinic~     14 times over that period. The main assessments will include visual acuity tests, eye~     examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus~     photography and fluorescein angiography (FA), measurement of intraocular pressure, blood~     pressure and pulse measurements and completion of health-related questionnaires'.~   "
193050|NCT01037335|"~     The goal of the current study was to evaluate the analgesic efficacy of low-dose morphine~     administered to the site of bone graft harvesting in patients undergoing orthopedic surgery.~     In addition to short-term analgesic effects, the incidence of chronic donor site pain was~     evaluated 1,3,6 m after surgery.~   "
193051|NCT01037322|"~     There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with~     cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol.~     cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat~     soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side~     effects.~      The aim of the proposed study is to examine in a double blind placebo controlled fashion the~     effect of cannabidiol on disease activity in patients with IBD.~   "
193052|NCT01037309|"~     The purpose of this study is to see whether PRO044 is safe and effective to use as medication~     for DMD patients with a mutation around location 44 in the DNA for the dystrophin protein.~   "
193053|NCT01037296|"~     Atrial fibrillation (AF) affects as many as 1 in 100 people and reduces the quality of life~     of large numbers of people in the UK and around the world. Catheter ablation is a minimally~     invasive treatment that has been developed to help eliminate AF. It is a complex procedure to~     perform so only a few hospitals are able to offer this treatment in the UK. A new technology~     allows the operator to guide their catheters (thin wires) in the patient by using a~     robotically steered sheath. This allows accurate and precise navigation that may improve the~     accuracy and integrity of ablation. We aim to prove whether this technology can make AF~     ablation easier and more effective.~      Substudy: Platelet reactivity and activation in AF, and the impact of curative ablation.~     Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet~     reactivity and activation are affected by AF compared to established normal ranges, and~     whether curative ablation impacts on this.~   "
193054|NCT01037283|"~     In patients with bipolar disorder referred for psychotherapy, is interpersonal and social~     rhythm therapy delivered in a group psychotherapy format over 2-3 weeks feasible? This~     project will help determine if interpersonal social rhythm therapy can be delivered in the~     programmatic format being considered for the outpatient mood program.~   "
193055|NCT01037270|"~     This is a multi-center study designed to evaluate the accuracy and precision of the INRatio®~     Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for~     low sample volume and heparin insensitivity, when used by trained medical professionals for~     the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick~     and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results~     will be compared to those PT/INR results obtained on plasma from the same subjects as~     analyzed at a central laboratory with the Sysmex CA-560 System.~   "
193056|NCT01037244|"~     Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the~     safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of~     PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).~   "
193057|NCT01037231|"~     The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering~     urinary oxalate levels in patients with primary hyperoxaluria.~   "
193063|NCT01037153|"~     Background:~      - Nicotine addiction is common among people who smoke tobacco, and the addictive properties~     of nicotine make smoking cessation difficult even for people who want to quit. Research has~     shown that smoking causes changes in the brain that lead to addiction and craving, but more~     research is needed to determine how different doses of nicotine and different intervals of~     receiving nicotine affect brain function. A greater understanding of nicotine's effect on the~     brain, as studied through functional magnetic resonance imaging (fMRI), may improve the~     effectiveness of smoking cessation therapies and treatments.~      Objectives:~      - To determine the effects of nicotine on brain function and chemistry in experienced~     cigarette smokers.~      Eligibility:~      - Current smokers (at least 20 cigarettes per day for at least 1 year) between 18 and 50~     years of age.~      Design:~        -  The study involves five separate research experiments. Most participants will be~          involved in only one experiment.~        -  The experiments will evaluate brain activity and function using fMRI. Participants will~          be trained in a series of tests on cognitive function before beginning the experimental~          part of the study.~        -  Experiment 1: Participants will have three fMRI scan sessions after receiving different~          dose levels of intravenous nicotine.~        -  Experiment 2: Participants will have four fMRI scan sessions after receiving two doses~          of nicotine separated by 1/4, 1/2, 3, and 24 hours.~        -  Experiment 3: Participants will have two sets of nicotine injections separated by 45~          minutes, with each injection series containing five rapid injections of small amounts of~          nicotine (to mimic five puffs on a cigarette).~        -  Experiment 4: Participants will have three fMRI sessions after receiving a single~          injection of nicotine at three different rates (over 15, 60, or 120 seconds). In~          addition there will be three more sessions involving a nicotine patch and a nicotine~          injection as well as a placebo session.~        -  Experiment 5: Participants will have three fMRI sessions that will involve looking at~          different kinds of pictures related to or not related to smoking after receiving a~          single injection of nicotine.~        -  Participants will also provide blood samples for further study....~   "
193064|NCT01037140|"~     Obesity is an increasing health problem with numerous metabolic complications. Vitamin D~     deficiency is common in obesity, and in epidemiological studies vitamin D deficiency has been~     linked to metabolic complications, such as type 2 diabetes, insulin resistance and~     cardiovascular disease, as well as myopathy, osteoporosis and depression. In obesity, a low~     grade inflammation is present in the fat tissue, thereby releasing inflammatory molecules to~     the blood stream. In cell line studies as well as small clinical studies vitamin D has been~     shown to have the ability to reduce inflammation and cell growth.~      In the present study the investigators wish to investigate the effect of vitamin D on fat-,~     muscle and bone metabolism. 30 healthy obese subjects will be treated with cholecalciferol~     175 micrograms daily for 6 months and will be compared with 30 healthy obese subjects treated~     with placebo.~      The investigators hypothesize that restoring vitamin D levels in vitamin D deficient obese~     subject will reduce inflammation and thereby reduce obesity-related complications.~      The effect will be evaluated as follows:~        -  Levels of circulating inflammatory markers will be examined in blood samples collected~          prior to and after treatment.~        -  Effects on fat- and muscle metabolism will be evaluated in fat- and muscle samples taken~          before and after treatment.~        -  Effects on fat distribution will be evaluated by MRI scan before and after treatment.~        -  Effects on insulin sensitivity will be evaluated by hyperinsulinaemic euglycaemic clamp~          performed on a subgroup of subjects with impaired fasting glucose.~        -  Effects on bone marrow density will be evaluated by DEXA scans before and after~          treatment.~        -  Effects on quality of life and depression score will be evaluated by questionnaires used~          before and after treatment.~   "
193065|NCT01037127|"~     MEK113583 is a Phase II open-label, multi-site study to investigate the objective response~     rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive~     melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent~     and highly selective inhibitor of MEK activation and kinase activity.~   "
193066|NCT01037114|"~     This study will evaluate the persistence of the immune response to HAV (hepatitis A virus)~     antigens and HBs (hepatitis B surface) antigens in healthy adults previously vaccinated with~     Twinrix™ Adult in the primary study, HAB-032 (208127/022). The subjects will be invited for~     blood sampling 16, 17, 18, 19 and 20 years after the primary vaccination to evaluate the~     antibody persistence. For subjects in whom low circulating antibodies are detected, the~     presence of immune memory against hepatitis A & B antigens will be investigated by the~     administration of a challenge dose of the appropriate vaccine (Havrix™ and/or Engerix™-B) at~     the next planned visit.~      No new subjects will be recruited during this study.~   "
193067|NCT01037101|"~     The study will determine the effects of D-Cycloserine (DCS) on fear reduction in patients~     diagnosed with phobia of heights (acrophobia) undergoing one session of three hours of~     virtual reality exposure therapy (VRET) or in vivo exposure therapy (IVET).~   "
193068|NCT01037088|"~     This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.~   "
193069|NCT01037075|"~     Background:~        -  Individuals with schizophrenia have a significantly higher tendency to develop substance~          abuse or dependence than the general population. For instance, people with schizophrenia~          smoke much more than the general population, and many are dependent on street drugs such~          as cocaine and heroin. However, these individuals are rarely included in research~          studies that might provide more information about treatments for both schizophrenia and~          substance abuse.~        -  Strong evidence suggests that schizophrenia and substance dependence have similar~          effects on the brain, affecting attention, memory, and eye movement. Other research~          indicates that schizophrenia and substance dependence affect the same parts of the~          dopamine system, contributing to problems in brain function that require treatment.~          These new developments provide a strong rationale to study the combination of~          schizophrenia and substance dependence.~        -  Nicotine may help improve brain function and thinking in individuals with both~          schizophrenia and drug dependence. Some of the thinking and memory problems experienced~          by these individuals can be treated with nicotine. However, more research is needed to~          determine exactly how nicotine affects individuals with both schizophrenia and drug~          dependence.~      Objectives:~        -  To determine whether individuals with schizophrenia and drug dependence show impairment~          in tests of eye tracking, attention, and memory compared with healthy control subjects.~        -  To evaluate the effect of nicotine on eye tracking, attention, and memory in individuals~          with both schizophrenia and substance dependence.~      Eligibility:~      - Current smokers (at least 10 cigarettes per day for the past year) between 18 and 55 years~     of age who (1) have been diagnosed with schizophrenia/schizoaffective disorder, (2) have been~     diagnosed with schizophrenia/schizoaffective disorder and are currently using heroin and/or~     cocaine, or (3) are healthy individuals with no family history of psychotic illness.~      Design:~        -  The study will consist of one training session and three testing sessions. Each session~          will last about 2 hours.~        -  The training session will introduce participants to the study tests and evaluate their~          tolerance of the nicotine nasal spray used in the study. Participants who cannot~          tolerate the higher dose of the spray will not continue in the study.~        -  At the start of each testing session, smokers will have one cigarette to standardize the~          time of the most recent exposure to nicotine.~        -  During the testing sessions, participants will receive a placebo spray, a lower dose of~          nicotine, or a higher dose of nicotine, and then will be asked to perform tests that~          evaluate attention, memory, and other thinking tasks.~   "
193070|NCT01037062|"~     To provide open-label entecavir to subjects who have completed previous blinded entecavir~     trials in Japan and are assessed by the investigator as likely to benefit from additional~     anti-hepatitis B therapy~   "
193071|NCT01037049|"~     The aim of this study is to determine whether greater rectal cancer downstaging and~     regression occurs when surgery is delayed to 12 weeks after completion of~     radiotherapy/chemotherapy compared to 6 weeks.~      Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to~     12 weeks after completion of CRT compared to 6 weeks.~   "
193072|NCT01037036|"~     The objective of this study is to investigate how the intraocular pressure (IOP)-lowering~     effect of the L-PPDS is altered by adjunctive Xalatan therapy.~   "
193073|NCT01037023|"~     Non-interventional, open-label, single group, multicentric post-marketing surveillance to~     monitor the safety and effectiveness of Topotecan administered in Korean patients according~     to the prescribing information~   "
193082|NCT01036724|"~     The purpose of this study is to determine the change in median radiation exposure time and~     median procedure time following guided radiofrequency (RF) ablation among subjects undergoing~     treatment for paroxysmal atrial fibrillation with either the CARTO® 3 or the NavX(TM) System.~      It is hypothesized that described features will reduce the median radiation exposure during~     the CARTO® 3 system-guided procedures compared to the NavX(TM) system-guided procedures.~   "
193155|NCT01035307|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at biomarkers in tissue samples from young patients~     with acute myeloid leukemia previously enrolled on clinical trial POG-9421.~   "
193074|NCT01036971|"~     Background:~      - The Neuroimaging Research Branch of the National Institute on Drug Abuse (NIDA) is~     interested in developing a pool of potential research participants who may be eligible for~     research studies on drug abuse and addiction, pharmacological and psychosocial therapies for~     substance addiction, and the long-term effects of drugs on the development, function, and~     structure of the brain and other organ systems. To develop this pool of potential~     participants, researchers intend to screen adolescents and adults who may be eligible for~     future research studies.~      Objectives:~      - To identify, recruit, and screen participants for NIDA neuroimaging research protocols.~      Eligibility:~      - Individuals 13 years of age and older who are able to provide informed consent.~      Design:~        -  Eligible participants will undergo two screening interviews: a telephone interview and~          an in-person interview. The phone interview will determine eligibility for the in-person~          interview. Adolescents who are eligible for further screening must bring a parent or~          guardian with them to the in-person interview.~        -  The in-person interview may require up to five visits to the NIDA clinical center. The~          in-person visit will involve any or all of the following procedures: (1) full physical~          examination and medical history; (2) psychiatric interview; (3) psychological testing;~          (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally~          invasive procedures as directed by the research staff.~        -  During the screening process, participants will be explicitly asked for permission to~          recontact them after the 1-year duration of the screening protocol. For minors, both the~          adolescent and the parent/guardian must agree to future contact.~        -  No clinical care will be provided under this protocol.~   "
193075|NCT01036958|"~     Background:~        -  Chronic graft-vs-host disease (GVHD) is an important cause of morbidity and mortality in~          patients undergoing allogeneic bone marrow transplantation. The symptoms of chronic GVHD~          are similar to those of other autoimmune diseases, and treatment for the pain often~          involves steroid use that can cause severe side effects over the long term.~        -  At present, there is no research instrument that measures symptoms in children with~          chronic GVHD. Treatment practitioners may use one of several pediatric quality of life~          questionnaires, but because none of these is specific for chronic GVHD each instrument~          has potential gaps in its ability to assess the full spectrum of problems experienced by~          children with chronic GVHD. Researchers are interested in developing a better~          understanding of the disease burden experienced by children and adolescents with chronic~          GVHD.~      Objectives:~      - To develop a Pediatric Chronic GVHD Symptom Scale (PCSS) that reliably measures the~     disease-specific burden of chronic GVHD in children.~      Eligibility:~      - Children and adolescents 5 to 18 years of age who have undergone prior allogeneic stem cell~     transplant and have been diagnosed with chronic GVHD that requires treatment.~      Design:~        -  There are two phases to the study; participants will enroll in phase I (question~          generation) at this time.~        -  Researchers will interview participants and ask open-ended questions (requiring more~          than a one- or two-word response) about symptoms that adults with chronic GVHD have~          found problematic.~        -  Both parents and children will participate in the interviews, which will be~          audio-recorded. Depending on the child or adolescent s age, the interviews may be~          conducted together with the parents or separately.~        -  No treatment will be given as part of this study.~   "
193076|NCT01036932|"~     The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF)~     therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF).~     The investigators hypothesize that ACLF is a disease where severe hepatic impairment is~     accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF~     therapy per se would increase the regenerative capacity of the liver and shall lead to~     clinical, biochemical and histological improvements in patients with ACLF.~   "
193077|NCT01036893|"~     This is a randomized, open-label, two-way cross-over drug-drug interaction Phase I trial.~      The objectives of this phase I trial are to investigate in healthy female subjects:~        -  the effect of prucalopride on the absorption of ethinylestradiol and norethisterone~          acetate, the active constituents of several oral contraceptives, after the first dose of~          prucalopride.~        -  the effect of multiple oral dosing of 2 mg prucalopride, for 6 days o.d. (steady state),~          on the pharmacokinetics of ethinylestradiol and norethisterone acetate.~      This trial will be conducted in healthy females of child bearing potential, i.e. females aged~     between 18 and 45 years (pre-menopausal).~   "
193078|NCT01036854|"~     The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and~     Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken~     on an empty stomach.~   "
193079|NCT01036841|"~     Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are~     considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal~     enuresis (MNE). Desmopressin exists in three different formulations for ambulant use: nasal~     spray, tablet and lyophilisate (MELT) each with differences in bioavailability (spray 2%,~     tablet 0.2%, MELT 0.5%). There 's insufficient evidence to confirm the actually used~     bioequivalent doses ( 10µg spray = 120µg MELT= 0.2mg tablet).~      Although so frequently used, very few pharmacokinetic and -dynamic data on desmopressin are~     available for children.~      Due to prolonged half life, associated with waterintoxication,the nasal spray has a black box~     warning from the FDA and is no longer recommended . For some authors oral formulations appear~     to be a safer alternative. However, based on clinical experience of less response rate with~     oral formulations, lower biodisponibility is suspected. Adult research confirms low~     bioavailability of tablets but also show major influences by food-intake and changes in~     gastro-intestinal motility.~      To achieve maximum efficacy, recommendations are to take desmopressin tablet 1 hour before~     bedtime and 2 hours after meal: this is unrealistic in schoolaged children since there never~     is 3 hours between evening meal and bedtime.~      In 2005 a dose response study demonstrated superior pharmaco-kinetic and dynamic properties~     for desmopressin Lyophilisate MELT formula.~      Since these results implicate superior action of MELT, often a change to MELT is recommended~     if there is a suboptimal response with tablet: sublingual absorption would eliminate the~     influence of food-intake.~      However, for this statement there's no evidence, since these tests were all conducted in~     children in fasting condition. Only one clinical study demonstrates bioequivalence for MELT~     and tablet.~      Hypothesis is that desmopressin MELT formulation has a better bioavailability when~     administered together with meal due to its sublingual absorption.~   "
193080|NCT01036802|"~     Sickle cell disease (SCD) is often referred to as a hypercoagulable state. However, the~     contribution of coagulation activation to the pathogenesis of SCD remains uncertain.~     Pulmonary hypertension (PHT) is a common complication associated with significant morbidity~     and mortality. Autopsy studies of SCD patients with PHT show evidence of in situ thrombosis~     involving pulmonary vessels, similar to findings in non-sickle cell patients with PHT.~     Anticoagulation has been reported to be of benefit in non-sickle cell patients with PHT. With~     the evidence of increased coagulation activation in SCD, PHT represents a clinical endpoint~     that may be used to evaluate the contribution of coagulation activation to the~     pathophysiology of SCD. The investigators hypothesize that increased thrombin generation, as~     well as platelet activation are central to the pathophysiology of SCD and contribute to the~     occurrence of several SCD-related complications, including PHT. As a consequence, treatment~     modalities that down-regulate thrombin generation would be expected to delay the progression~     of PHT and result in improved survival in patients with SCD.~   "
193081|NCT01036763|"~     Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18~     mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the~     most important outcome parameters according to the physicians assessment to determine the~     success of therapy. Such data are not yet available.~      Also collection of physicians assessments and patients assessments of efficacy and~     tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).~   "
193124|NCT01035749|"~     The purpose of this study is to show that vaccination with a single dose of GSK Biologicals'~     pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines~     Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a~     pandemic influenza vaccine.~   "
193083|NCT01036711|"~     Background:~      - Many cigarette smokers claim that smoking improves their ability to think and concentrate,~     and have reported problems in thinking and concentration after quitting smoking. Some~     research has indicated that nicotine can enhance certain aspects of attention and memory in~     humans. However, more research is needed to determine how nicotine affects different elements~     of the brain s ability to think, pay attention, respond to rewards, and make decisions.~     Researchers are interested in using functional magnetic resonance imaging (fMRI) to study the~     effects of nicotine on brain function and activity.~      Objectives:~      - To determine the effects of nicotine on attentional and other thinking processes, including~     reward-seeking behavior.~      Eligibility:~      - Individuals between 18 and 50 years of age who are either current smokers (10 or more~     cigarettes per day for at least 1 year) or nonsmokers.~      Design:~        -  The study has four experiments. Each experiment requires two MRI scanning sessions and a~          training session. Participant can do one or all of the experiments.~        -  Participants will receive training on the types of computerized tests that will be given~          during the active portion of the study. Participants will also fill out questionnaires~          on nicotine use and other alcohol and drug use, and provide breath and urine samples.~        -  During the test sessions, participants will have fMRI scanning while performing up to~          four different sets of tasks that test attention, memory, concentration, reward-seeking~          behavior, and decision making. Smokers will wear a nicotine patch or placebo patch~          during the test sessions, but will not be told which patch they are receiving. The order~          of these sessions will be different for individual participants.~        -  Participants will provide blood and urine samples throughout the research study for~          evaluation purposes.~   "
193084|NCT01036685|"~     Background:~        -  Drugs of abuse have effects on mood, behavior, thinking, and decision making that may~          encourage people to continue using them and make it difficult for them to stop.~          Researchers who study these effects are interested in developing new tests to evaluate~          how drugs and drug use affect different areas of the brain.~        -  Magnetic resonance imaging (MRI) scans allow researchers to study brain activity and~          changes to brain function. When specific psychological tests are performed during~          functional MRI (fMRI) scans, researchers can examine the effects of drug use on the~          brain. By developing and testing new procedures for fMRI studies, more information can~          be obtained on brain function and activity in drug-using and non-drug-using individuals,~          and this information can help develop new treatments and therapies for substance abuse.~      Objectives:~      - To evaluate the effects of newly developed psychological procedures to be performed during~     fMRI scans.~      Eligibility:~        -  Healthy volunteers between 13 and 55 years of age who are willing to undergo MRI~          scanning.~        -  Both drug-using and non-drug-using individuals will be selected for this study.~      Design:~        -  Before the start of the study, participants will complete questionnaires about medical~          and psychological history, and provide information about past or current drug use.~          Researchers will introduce the tasks to be performed during the scanning session(s), and~          will allow participants to practice the test either on a separate computer or on the~          computer used during the MRI scan.~        -  During the study, participants will be asked to do one or more tasks selected by the~          researchers. The tasks will be performed on a computer in an MRI machine, and may~          involve receiving rewards (such as money or sips of juice) for actions, memory and~          reaction-time tests, or other tests that involve responding to instructions on the~          screen.~        -  Participants will receive compensation for their participation in the study, including~          hourly compensation for individual visits and lump-sum compensation for each MRI~          scan....~   "
193085|NCT01036659|"~     The investigators will conduct a double-blind, randomized controlled trial comparing the~     safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design~     will be used such that patients failing to improve on standard therapy will additionally be~     treated with ecallantide. Therefore, a historical control cohort will be enrolled for~     analysis of secondary endpoints. In addition, since some patients treated with conventional~     therapy may improve rapidly and therefore not be eligible for inclusion in the study, the~     investigators will enroll these patients as an observational arm to enable the conduct of~     sensitivity analysis.~   "
193086|NCT01036646|"~     This multi-center study is designed to evaluate the ability of intended lay users (patients~     on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio~     Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for~     low sample volume and heparin insensitivity, and 2) obtain accurate results for the~     quantitative determination of International Normalized Ratio (INR) when self-testing using~     fingerstick capillary blood. Patients will be trained by their healthcare provider using the~     instructions for use and product labeling provided. The accuracy of the patient INR results~     will be assessed by comparison to the INR results obtained by the site's trained healthcare~     professional using the same INRatio system (from a separate fingerstick collected from the~     same patient at the point-of-care), and with the INR results obtained on venous plasma~     obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560~     System INR reference method.~   "
193087|NCT01036633|"~     The purpose of this study was to:~        1. To investigate the feasibility of using infrared (IR) thermometer to grade the severity~          of oral mucositis in patients with multiple myeloma undergoing chemotherapy.~        2. To obtain preliminary data on the most optimal method of scoring the severity of oral~          mucositis by comparing the results obtained using the IR thermometer to the World Health~          Organization (WHO) mucositis grading system and the patient self-assessment~          questionnaire.~        3. To Investigate the correlation between the quantitative readings obtained from oral~          mucosa with the IR thermometer.~   "
193088|NCT01036594|"~     This is an open label, phase II, single center trial of ketoconazole/dexamethasone to~     determine if the administration of ketoconazole/dexamethasone, after disease progression with~     ketoconazole/hydrocortisone slows or reverses disease progression in men with progressive~     prostate cancer.~   "
193089|NCT01036581|"~     Background:~      - Functional and structural magnetic resonance imaging (MRI) techniques have allowed~     researchers to map and study how the brain works when at rest and when engaged in specific~     tasks. MRI scans have provided more information about how drugs affect the brain, and about~     how drug addiction changes the brain and influences behavior, mood, and thinking processes.~     To better understand the underlying mechanism of drug addiction and to develop strategies for~     more effective treatment, researchers are interested in developing new MRI techniques to~     study the effects of addiction on the brain.~      Objectives:~      - To develop new functional and structural MRI techniques, and to evaluate their potential~     use in brain imaging studies related to addiction.~      Eligibility:~        -  Individuals between 18 and 55 years of age.~        -  Participants may be smokers or nonsmokers, and may use drugs or not use drugs.~      Design:~        -  During the initial screening, participants will complete questionnaires about family and~          personal history, drug use, and other information as required by the researchers.~          Participants who will be asked to complete tasks during the MRI scan will be shown how~          to perform these tasks before the scanning session.~        -  Before each study session, participants may be asked to complete some or all of the~          following: questions about their drug use during the last week, a breathalyzer test, a~          urine drug-use assessment, a urine pregnancy test, or a measure of carbon monoxide.~          Participants will also provide blood samples before the start of the scan.~        -  For each scanning session, participants will have an MRI scan that will last~          approximately 2 hours.~        -  MRI scans may include injections with a contrast agent to study brain function, specific~          tasks to be performed during the scan, or an experiment that studies the brain's~          response to carbon dioxide....~   "
193136|NCT01035554|"~     We propose to test an intervention to increase patients' understanding of the causes,~     consequences, and the rationale for treatment, of their hypertension (HTN), as a strategy for~     increasing blood pressure (BP) control. The focus is on the interaction between a behavioral~     intervention to reduce BP - home BP monitoring (HBPM) - and patient knowledge, which, we~     propose, moderates the effect of the HBPM intervention. We hypothesize that patients who have~     a better understanding of their illness and its prescribed treatment will be more adherent to~     the treatment regimen, and thus will exhibit improved outcomes compared to those who have~     been exposed to the same intervention, but who do not have a clear understanding of these~     elements.~   "
193137|NCT01035541|"~     This study is designed to compare renal outcome of patients following major non-cardiac~     surgery with different perioperative hemodynamic managements: a goal directed hemodynamic~     management group (using PiCCO) and a control group.~   "
193090|NCT01036568|"~     Background:~      - Eye tracking, the ability to focus on and follow a moving target with the eyes, is often~     difficult for people who have schizophrenia. Research has shown that first-degree relatives~     of people with schizophrenia, such as parents and siblings, also tend to have difficulty with~     smooth eye movement and eye tracking. Researchers are interested in using functional magnetic~     resonance imaging (fMRI) to study brain activity during eye tracking tests in order to better~     understand the effect that schizophrenia has on brain function.~      Objectives:~      - To study eye-tracking and eye-tracking impairments in people with and without~     schizophrenia.~      Eligibility:~      - Individuals between 18 and 62 years of age in one of three groups: (1) patients who have~     been diagnosed with schizophrenia/schizoaffective disorder, (2) first-degree relatives of~     patients in group 1, and (3) healthy volunteers with no family history of psychosis.~      Design:~        -  The study will involve two visits, one screening session and one testing session. Each~          session will take about 3 hours.~        -  Participants will be asked to avoid consuming alcohol and restrict consumption of~          caffeine before the start of the study. Participants will provide urine and breath~          samples to be tested for chemicals that may interfere with the study.~        -  Participants will visit the clinical center the morning of the day before the scanning~          session to provide blood and urine samples as required. Participants will return and be~          admitted for an overnight stay later that afternoon or evening.~        -  During the screening session, participants will provide a medical and psychological~          history, provide blood samples, and learn the eye movement tasks they will do during the~          scanning session.~        -  During the scanning session, participants will have an fMRI scan. During the scan, they~          will perform eye movement tasks that involve following moving light targets on a screen,~          and will also perform other tasks that test the ability to think and pay attention.~   "
193091|NCT01036529|"~     The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness~     and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as~     a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as~     persistent or recurrent pain following one or more lumbosacral spine surgical procedures.~     Surgical procedures that can result in FBSS can be categorized as either decompression or~     decompression followed by fusion with or without instrumentation. The pain of FBSS is~     categorized as neuropathic, which involves pathological nerve activity and is commonly~     characterized by patients as shooting or burning and/or nociceptive, which signals actual or~     impending tissue damage or inflammation.~   "
193092|NCT01036516|"~     Background:~        -  Cues related to past drug use induce a particular pattern of brain activation, which has~          been correlated with craving for cocaine in active cocaine abusers. Researchers are~          interested in determining the role of the brain chemical dopamine in cue-elicited as~          well as spontaneous craving for cocaine.~        -  To study the role of dopamine in cocaine craving, researchers will use positron emission~          tomography (PET) to compare the neural reactions of cocaine users with those of~          non-substance-abusing healthy volunteers. Researchers hope that the data gathered from~          this study will lead to the development of more effective anti-craving medications.~      Objectives:~        -  To clarify the role of dopamine in cue-elicited responses that contribute to cocaine~          abuse.~        -  To determine if PET results of this study differ with various means of administering PET~          chemicals.~      Eligibility:~      - Individuals 21 to 44 years of age who are either current cocaine users (at least twice per~     week) or healthy volunteers without a history of drug abuse.~      Design:~        -  Cocaine-using participants will enter the inpatient clinical research ward at the~          National Institute on Drug Abuse (NIDA) Addiction Research Center for 2 nights before~          the day of the study. In addition, these participants will stay overnight at NIDA the~          evening after each PET session and will be discharged the following day. Cocaine-using~          participants will be required to perform a balance test before the study to provide a~          baseline response in case they require anti-anxiety medications to cope with the effects~          of the study.~        -  Control subjects will not be required to stay overnight and will arrive as outpatients~          for the PET session. All participants will be required to abstain from alcohol and~          caffeine consumption from midnight before each study session, and will not be permitted~          to smoke on the day of testing.~        -  - On the day of the study, participants will undergo a practice session to set up the~          PET scanning equipment. Following the practice session, participants will be shown video~          recordings of images that are related to nature (e.g., seashells) or to drug abuse~          (e.g., drug paraphernalia). Participant reactions will be studied through the PET~          monitoring, and the study will be conducted in two separate PET sessions with a break in~          between. Individuals in the cocaine-using group may receive anti-anxiety medication if~          the stimulus cues increase anxiety related to cocaine craving.~        -  Different groups of participants will receive different methods of PET chemical~          administration, and researchers will compare these methods.~   "
193093|NCT01036490|"~     Patients with type 2 diabetes, obesity, and chronic kidney disease are generally physically~     inactive, have a high mortality rate, and may benefit from an exercise program. This study~     seeks to determine if a structured exercise program will benefit the heart (improved exercise~     tolerance, decreased blood pressure) and/or the kidney (decreased protein loss in urine and~     stabilization of kidney function) and lead to improvements in diabetes, body composition, and~     quality of life.~   "
193094|NCT01036438|"~     Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the~     equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer~     with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound~     size reduction.~   "
193095|NCT01036412|"~     The goal of this clinical research study is to find out if 1% chlorhexidine gluconate gel~     will decrease the amount of bacteria that causes tooth decay. Whether the gel is acceptable~     to patients will also be studied.~   "
193096|NCT01036399|"~     Revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has~     direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell~     costimulatory properties. Both preclinical and clinical data indicate its efficacy solid~     tumor and multiple myeloma including advanced/refractory stages with its role in enhancing~     host antitumor immunity that provided the rationale to use in patients with PTCL.~   "
193097|NCT01036360|"~     Physical activity is mainly considered and use for its impact on energy expenditure in the~     treatment of obesity, and less is known concerning its indirect effects on energy intake. The~     aim of this work is to clarify the impact of an acute bout of exercise, depending on its~     intensity (high versus low), on the following energy intake and nutrient utilization, in~     obese and non-obese boys and men.~   "
193098|NCT01036321|"~     The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and~     scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo~     for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. A~     placebo is a pill or something that looks like the medicine that is being studied but has no~     active medicine in it. We also want to see if taking purified isoflavones is safe and if it~     reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones~     are able to slow the progression of prostate cancer, and the mechanism of action of purified~     isoflavones. If the safety and the effects of purified isoflavones on slowing down the~     progression of prostate cancer is shown in our study, this will also be a safe way of~     treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer~     in the future.~   "
193099|NCT01036308|"~     The objective of the conducted study was to determine the efficacy of the native legume~     kernel fibres of Lupinus angustifolius Boregine (Boregine), Lupinus albus Typ Top (TypTop)~     and Glycine max Hefeng (Soy fibre) on prevention of risk factors for gastrointestinal or~     cardiovascular diseases.~   "
193100|NCT01036282|"~     The study is designed to evaluate the effectiveness of computerized cognitive skills training~     for improving memory and problem-solving skills in inpatients with schizophrenia.~   "
193101|NCT01036243|"~     To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter~     formula containing probiotics compared to infants fed a control hydrolyzed and referenced~     non-hydrolyzed formula.~   "
193102|NCT01036230|"~     Background:~        -  Environmental cues frequently induce expectancies in individuals that may strongly~          influence the actual experience associated with the cue. This has both positive and~          negative consequences for behavior and decision making. For instance, when an addicted~          individual experiences cues associated with imminent drug taking, an expectancy of the~          coming experience is also formed and very likely has an effect on the subsequent~          experience of the drug.~        -  Researchers are interested in studying how the brain responds to these kinds of~          environmental cues and expectancies in order to learn more about addiction and craving~          in substance-abusing individuals.~      Objectives:~        -  To compare the response to rewards (both drug-related and non-drug-related) in cocaine~          users and non-using individuals.~        -  To study the effect of expectation on reward-related (both drug-induced and~          non-drug-induced) responses and brain activity in cocaine users and non-using~          individuals.~      Eligibility:~      -Individuals between 18 and 45 years of age who are regular cocaine users but otherwise~     healthy, or healthy individuals who are not cocaine users.~      Design:~        -  This study involves two experiments. Participants will be assigned to one or both~          experiments.~        -  Participants must not use any drugs for at least 3 days before the visit, may not~          consume alcohol for 24 hours before the visit, and may not consume caffeinated beverages~          for 12 hours before the visit. On the day of the visit, participants will provide both~          urine and breath samples to test for drug/alcohol use.~        -  Experiment 1: In the MRI scanner, participants will respond to questions and images on a~          screen, and will receive small amounts of flavored liquid (chocolate or cherry) through~          a tube in the mouth.~        -  Experiment 2: In the MRI scanner, participants will respond to questions and images on a~          screen, and will receive injections of liquid (saline solution or a drug that provides a~          high similar to cocaine) through an intravenous line. Participants in this experiment~          will return for follow-up visits and provide urine samples for further study.~        -  The specific assignment (to Experiment 1 or Experiment 2 or both experiments) will~          determine the number of study days and follow-up visits required.~   "
193103|NCT01036217|"~     Background:~      - The National Institute on Drug Abuse (NIDA) uses a standardized set of procedures to~     develop a pool of potential participants for research studies. Because some of the data~     collected during screening are used later for research, the screening itself is considered a~     study. An applicant to any NIDA study is considered a participant in NIDA screening.~      Objectives:~      - To identify, recruit, and screen participants for NIDA research protocols.~      Eligibility:~      - Individuals 18 years of age and older who are able to provide informed consent.~      Design:~        -  Individuals who are eligible for screening will undergo two interviews: a telephone~          interview and an in-person interview. The phone interview will determine eligibility for~          the in-person interview.~        -  The in-person interview may require up to five visits to NIDA. The in-person visit will~          involve any or all of the following procedures: (1) full physical examination and~          medical history; (2) psychiatric interview; (3) psychological testing; (4)~          electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally~          invasive procedures as directed by the research staff.~        -  During screening, a photograph will be taken for confirmation of identity during~          subsequent visits for other studies.~        -  No clinical care will be provided as part of screening.~   "
193104|NCT01036165|"~     The purpose of this study is to test the RebiSmart™ for~        -  ease of use~        -  multiple domains related to subject's acceptability and satisfaction~        -  reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in~          subjects with RMS.~   "
193105|NCT01036139|"~     To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the~     long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649~     in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's~     Disease.~   "
193106|NCT01036126|"~     Background:~      - Relapse to drug abuse often happens in the presence of stimuli that are associated with~     previous drug use, also known as cues. Drug-taking behavior appears to be partly controlled~     by such cues. Some research suggests that cue-induced craving states are responsible for drug~     use and relapse, but other research suggests that cues can control drug taking without~     conscious craving or even awareness. Researchers are interested in using functional magnetic~     resonance imaging (fMRI) to study how individuals respond to drug-related cues and how these~     cues affect craving on a conscious or unconscious level.~      Objectives:~      - To determine how drug-related stimuli (cues) affect thinking, information processing, and~     body reactions in current drug users.~      Eligibility:~      - Individuals between 18 and 50 years of age who are dependent on either tobacco or~     crack-cocaine, or are healthy volunteers who are not dependent on either drug.~      Design:~        -  The study will require two sessions, a training session and a testing session, that will~          take place within 48 hours of each other. Between the two test sessions, participants~          may not consume alcohol, tobacco, or illegal drugs, and must restrict caffeine~          consumption.~        -  During the first session, participants will complete questionnaires about~          tobacco/cocaine use and craving, and will be trained on the tasks to be performed in the~          MRI scanner.~        -  During the second session, participants will perform concentration tasks and look at~          pictures, some of which will be tobacco/cocaine related. Body reactions such as heart~          rate, pupil dilation, and sweating will be measured during this session. Some~          participants will have actual MRI scanning, while others will have mock MRI scanning.~        -  After the MRI session, participants will complete questionnaires about craving and~          responses to the scan.~   "
193107|NCT01036113|"~     This is a Phase 2, multicenter, open-label, noncomparative study to evaluate safety,efficacy~     and of single-agent EZN 2208 administered in patients with previously treated MBC.~      After discontinuation of study treatment, patients will receive care as considered~     appropriate by the investigator. Patients will continue to be followed for disease~     progression, subsequent anticancer therapy, and survival.~   "
193108|NCT01036087|"~     The goal of this clinical research study is to learn how effective the combination of~     chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and~     fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of~     IBC is. The safety of PNC combination will also be studied.~   "
193109|NCT01036074|"~     Background:~      - Cocaine affects the brain's ability to process information. However, different people~     respond to cocaine in different ways, and differences in brain structure and function may~     affect how cocaine alters brain activity. By using functional magnetic resonance imaging~     (fMRI) to monitor brain activity during tasks that provide simple rewards, researchers hope~     to better understand how the brain responds to rewards and how this response is affected by~     drugs like cocaine.~      Objectives:~        -  To determine the effect of cocaine administration on the reward experience in~          cocaine-dependent individuals.~        -  To study genetic and personality factors that may contribute to cocaine dependence.~      Eligibility:~      - Individuals between 18 and 45 years of age who either are cocaine-dependent and not seeking~     treatment or are healthy volunteers.~      Design:~        -  Participants will be asked to avoid consuming alcohol and restrict consumption of~          caffeine prior to the study. Participants provide urine and breath samples to be tested~          for chemicals that may interfere with the study.~        -  All participants will complete a training session and at least one fMRI scanning~          session. During the training session, participants will be introduced to the reward~          tasks and MRI equipment.~        -  Healthy volunteers will have a single fMRI session that will involve reward tasks to be~          completed during the scanning. Rewards will include small amounts of fruit juice and the~          opportunity to win money.~        -  Cocaine-dependent participants will have a training session and three experimental~          sessions including 1) a mock MRI scan to test cocaine tolerance, 2) one fMRI scan with~          reward tasks after administration of IV cocaine, and 3) one fMRI scan with reward tasks~          after administration of IV placebo (saline solution). Rewards will include small amounts~          of fruit juice and the opportunity to win money.~        -  In addition to the scans, participants will provide a blood sample for further study and~          will answer questionnaires provided by the researchers.~   "
193110|NCT01036061|"~     The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.~   "
193111|NCT01036048|"~     A meta-analysis to compare outcomes of drug eluting stents (DES) versus bare metal stent~     (BMS) in saphenous vein graft (SVG) disease.~   "
193112|NCT01036035|"~     THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic~     agonist (pilocarpine).~   "
193203|NCT01034683|"~     The purpose of this study is to evaluate the efficacy and the toxicity of lobaplatin,~     5-fluorouracil (5-FU) and leucovorin in patients with esophageal carcinoma.~   "
193113|NCT01036022|"~     This study is the first-time-in-patient trial of GSK1399686, a novel locally-acting~     anti-inflammatory compound, aimed at obtaining initial information on the tolerability,~     safety, pharmacokinetics (including concentrations in colon mucosa) and anti-inflammatory~     activity of GSK1399686 upon oral dosing in patients with active ulcerative colitis.~      The study is designed as a randomized, double-blind, double-dummy, placebo-controlled,~     sequential dose escalating trial, with an active control (ASACOL) group as internal control.~     Up to three cohorts (Cohorts 1-3), each consisting of approximately 20 patients with~     mild-moderately active ulcerative colitis not limited to the rectum, will be included, one~     for each dose level of GSK1399686 to be tested. Within a cohort, patients will be randomized~     in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing~     with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively.~      An interim analysis of fecal markers and disease activity data will be performed by the end~     of Cohort 3. Based upon results, the study may be stopped or continued by recruiting either~     Cohort 4 (if data on an additional dose level would be warranted to establish or clarify a~     dose-response relationship) or, in the case of a robust efficacy signal at any dose level~     previously studied, Cohort 5 (to expand the sample size for given dose level in order to~     evaluate the efficacy of GSK1399686). The number of patients and randomization allocation~     ratio may be altered in Cohort 5 and it may not include an active control arm. If Cohort 4 is~     initiated upon interim analysis, then a second interim analysis may be performed at the end~     of Cohort 4, to assess whether progression into Cohort 5 (as defined above) would be~     justifiable.~   "
193114|NCT01036009|"~     There is no curative therapy once acute leukemia patients relapse after transplant. Patients~     who develop clinically significant graft versus host disease (GVHD) have a lower rate of~     relapse than those who do not develop GVHD. We are initiating this study of post-transplant~     fast withdrawal of immunosuppression and donor lymphocyte infusions, with a goal of achieving~     full donor chimerism in children with hematologic malignancies. If our hypothesis that full~     donor chimerism results in leukemia-free survival is correct, using immune modulation to~     achieve full donor chimerism should decrease relapse rate and thus increase survival. The~     goal of this Phase II study is to identify if achieving full donor chimerism in whole blood~     CD3+ and leukemia-specific (CD14/15+, CD19+, CD33+ and CD34+) subset may decrease the risk of~     relapse of patients undergoing allogeneic transplant for hematologic malignancy.~   "
193115|NCT01035996|"~     Background:~      - Schizophrenia is associated with cognitive impairment in different parts of the brain,~     including those associated with learning and memory. The brain activity associated with these~     impairments, however, is poorly understood. Researchers are interested in studying how the~     brain chemical dopamine, which is involved in responding to incentives and rewards like money~     or food, works differently in the brains of people who have schizophrenia.~      Objectives:~      - To study reward processing in individuals with schizophrenia who are taking different types~     of medication, compared with healthy volunteers.~      Eligibility:~      - Individuals between 18 and 55 years of age who (a) have been diagnosed with~     schizophrenia/schizoaffective disorder and are taking the antipsychotic medication clozapine,~     (b), have been diagnosed with schizophrenia/schizoaffective disorder and are taking a~     different second-generation antipsychotic, or (c) are healthy volunteers.~      Design:~        -  This study will involve one screening visit and one or more visits for testing and~          functional magnetic resonance imaging (fMRI) scans. During the screening visit,~          participants will complete questionnaires and provide information about their physical~          and psychological health.~        -  Participants will receive training in the tasks to be performed at the scanning sessions~          during the screening visit.~        -  During the fMRI scans, participants will complete one or two of four possible~          reward-based tasks:~        -  A task that enables participants to win money based on their response to a target item.~        -  A task that provides small amounts of juice over specific time intervals, followed by a~          procedure to be completed outside the scanner.~        -  A task that involves choosing figures or shapes and winning money based on responses.~        -  A game of chance involving predictions based on shapes shown on a screen.~        -  Participants will also provide blood samples for research and testing.~   "
193116|NCT01035983|"~     In this open-label, multi-center study, patients were treated with frovatriptan for a maximum~     of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the~     anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6~     days. Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on~     Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6. During the study, patients~     were to visit the study site a total of 6 times. Efficacy and/or safety assessments were~     performed at each visit.~   "
193117|NCT01035944|"~     The purpose of this study is to determine if the use of HemCon chitosan-based dressings is~     effective to facilitate safe, effective debridement of chronic wounds in the operating room~     and inpatient ward settings and to minimize bacterial re-colonization of wounds.~   "
193118|NCT01035905|"~     The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic~     contact lens wearers when fit with one of two different daily disposable contact lenses.~   "
193119|NCT01035879|"~     To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at~     three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4~     weeks in patients that are treatment-naive or taking a single anti-diabetic medication~     (non-TZD, non-injectable).~   "
193120|NCT01035853|"~     The purpose of this study is to determine whether the nasal inhalation of Colistin is~     effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.~   "
193121|NCT01035801|"~     The purpose of this study is to see whether IN-105 (oral insulin) is able to control increase~     in blood glucose after eating a meal. This study will also tell whether single tablet of~     IN-105 is safe for patients with Type 1 diabetes mellitus who are currently taking insulin~     injections.~   "
193122|NCT01035788|"~     The purpose of this study is to first adapt Cognitive Behavioral Conjoint Therapy for PTSD~     for Operation Enduring Freedom and Operation Iraqi Freedom (OEF-OIF) Veterans diagnosed with~     PTSD and their intimate partners by (1) reducing the overall length of treatment from 15~     weeks to 10 weeks through the use of a weekend couple retreat to deliver the first two of~     three phases of the three-phase protocol; and (2) by integrating mindfulness interventions as~     a way to mitigate the short, more condensed treatment. Secondly, this study will examine the~     effects of this adapted Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD~     symptoms and intimate relationship functioning.~   "
193123|NCT01035775|"~     Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and~     has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused~     on the withdrawal phase of the examination. This randomized, controlled trial will compare~     the additional effect on the rate of adenoma detection of mucosal inspection during~     colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing~     colonoscopy for colorectal cancer screening or surveillance.~   "
193204|NCT01034670|"~     To develop new methods to detect malignant and premalignant conditions of the~     gastrointestinal tract.~   "
193125|NCT01035723|"~     Background:~      - New research on genetics and the human genome has helped to identify certain genes that~     affect specific parts of the brain, including the parts that may be involved in drug use and~     dependency. Researchers are interested in studying both genetic information and brain~     activity to better understand variations in brain function among individuals.~      Objectives:~      - To study brain activity in conjunction with specific genetic information provided by~     healthy volunteers including smokers, non-smokers, people with drug dependence, and those who~     do not have any dependence on any substance.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age.~      Design:~        -  This is an 8 10 hour study which may be completed in 1, 2, or 3 visits.~        -  Participants will complete questionnaires about emotional and psychological responses to~          different situations, including stressful situations.~        -  Participants will have a training session in a mock (fake) scanner to practice tasks to~          be completed in the real scanner.~        -  Participants will have the following two types of magnetic resonance imaging (MRI) scans~          in one scan session of the brain:~        -  A structural MRI scan to provide basic information about each participant's brain.~        -  A functional MRI scanning session, in which participants will perform a memory task to~          provide information about brain activity.~        -  Participants will provide blood samples for research and testing....~   "
193126|NCT01035697|"~     This observational study assessed whether measurements of certain pro-inflammatory and~     anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up~     to day of life 21 can predict cerebral palsy at 18-22 months corrected age.~   "
193127|NCT01035671|"~     This is a Phase 2a double-blind, placebo-controlled study with two dose levels of A0001 given~     twice daily for 28 days. Potential subjects will be screened first to determine eligibility,~     after which they will be randomized to receive either a high dose of A0001, a low dose of~     A0001 or placebo for 28 days.~      Eligible subjects will return within 21 days of screening for the baseline visit and~     randomization to one of three potential treatments. The subjects will be required to take 3~     capsules of study medication in the morning with a morning meal and 3 capsules of study~     medication at night with an evening meal for 28 days. Additional visits to the clinic are~     planned for Day 14 and Day 28, at which time a number of clinical and biochemical assessments~     will be done.~   "
193128|NCT01035658|"~     In this study, patients with relapsed or refractory ovarian cancer will receive treatment~     with pazopanib and liposomal doxorubicin (Doxil) until disease progression or unacceptable~     toxicity occurs. The Phase I portion will define the dose limiting toxicity (DLT) of~     pazopanib and liposomal doxorubicin when administered in combination. Once the maximum~     tolerated dose has been identified in the Phase I portion, the Phase II portion will evaluate~     efficacy and safety of this combination in the same patient population.~   "
193129|NCT01035645|"~     GSK1070806 is a humanised monoclonal antibody that blocks a protein present in the body~     called Interleukin-18. The main purpose of this study is to test GSK1070806 in healthy and~     obese male subjects with normal immune systems to find out how safe this drug is and how long~     the body takes to get rid of it. The study consists of 2 parts. Part 1 will consist of 6~     groups of healthy male subjects and Part 2 will consist of 3 groups of obese male subjects. A~     total of 89 subjects is planned for this study. Subjects in each group will receive one dose~     of the study drug or placebo. Dosing in Part 2 will not start until dosing of the first 4~     groups is completed in Part 1 and the preliminary safety and pharmacokinetic data from these~     4 groups in Part 1 has been reviewed. Both parts will be conducted single-blind and with a~     placebo control. Within each group, allocation of subjects to placebo or active treatment~     (GSK1070806) will be randomised.~   "
193130|NCT01035632|"~     Background:~      - Relapse following cigarette abstinence remains a common problem for smokers who are~     attempting to quit. Most research has focused on the acute withdrawal phase that occurs~     within the first 48 hours to 1 week after quitting; however, more information is needed on~     the experiences of smokers in longer durations of abstinence.~      Objectives:~        -  To study the effects of long-term smoking abstinence.~        -  To study the effects of cigarette-related cues on craving in longer periods of smoking~          abstinence.~      Eligibility:~      - Individuals at least 18 years of age who are current smokers (at least 10 cigarettes per~     day) and who want to quit but are not currently attempting to quit.~      Design:~        -  Participants will be randomly assigned to abstain from all nicotine use for 7, 14, or 35~          days. A fourth group of participants will also abstain for 35 days, but will undergo~          more testing sessions than the other groups.~        -  All participants will have an initial orientation session in which they will complete~          questionnaires about their smoking habits and will respond to smoking-related cues to~          provide information about their cravings.~        -  Participants will visit the clinic daily during their abstinence period, and provide~          urine and breath samples to test for tobacco use. Participants will receive compensation~          for every day that they do not use tobacco.~        -  On the end day of the abstinence period, participants will return to the clinic, provide~          urine and breath samples, and undergo testing of their responses to smoking-related~          cues. Participants in the fourth group will have these tests on Days 7, 14, and 35 of~          abstinence; other participants will have the tests only once, at the end of their~          abstinence period.~        -  After the required abstinence period, participants will enter a 5-day step-down period.~          They will continue to report to the clinic for breath and urine testing, and they will~          receive payments for abstinence that decrease in value across days.~        -  After the step-down period, for the final 12 days of the study, participants will report~          to the clinic every 3 days to give urine and breath samples and to report the number of~          cigarettes smoked.~   "
193131|NCT01035619|"~     The purpose of this study is to measure the amount of moxidectin in subjects' blood and to~     measure safety. This study will enroll 36 children aged 4 to 11 years (>=12 kg) with or~     without Onchocerca volvulus (O volvulus) infection. O volvulus is the nematode, or roundworm,~     that causes Onchocerciasis, also known as river blindness. Each subject will receive a single~     dose of 4 mg moxidectin (orally administered) and will be followed inpatient from screening~     through day 13 and as outpatients through month 6. The study will take place at a single~     research center.~   "
193132|NCT01035606|"~     Brain injuries affect the lives of numerous Veterans. This study examines how the brain is~     affected by injury and how rehabilitation training for attention dysfunction may change brain~     functioning.~   "
193133|NCT01035593|"~     The purpose of this study will be to assess the safety, tolerability, and efficacy of rhC1INH~     in renal transplant recipients with biopsy-confirmed antibody-mediated rejection (AMR) within~     30 days of renal transplantation. This study will combine the investigational drug rhC1INH~     with a standard regimen of plasmapheresis (PP) and intravenous immune globulin (IVIG) and~     compare this to PP and IVIG alone.~   "
193134|NCT01035580|"~     The main objective of this study is to determine the maximum tolerable dose and safety of~     intravaginal curcumin in a normal population of women (women with no evidence of cervical~     cytological abnormalities by pap testing).~   "
193135|NCT01035567|"~     The purpose of the study is to assess the safety and efficacy of hybrid revascularization in~     comparison with coronary artery bypass grafting among patients with multivessel coronary~     artery disease.~   "
193138|NCT01035528|"~     The field of secondary prevention remains an extremely important goal for diagnostic and~     therapeutic approaches keeping in mind that 40% of all patients with acute myocardial~     infarction have prediabetes, commonly as impaired glucose tolerance, which has not been known~     and treated and for which there are no guidelines for treatment. In this context,~     accumulating evidence shows beneficial effects for treating diabetes mellitus early in the~     course of disease, whereas other evidence shows that aggressive antidiabetic therapy may be~     associated with undesired risks. Accordingly, the present randomized and controlled pilot~     study is designed as hypothesis creating study to create first data about potential~     medication in early type 2 diabetes including impaired glucose tolerance of patients with~     known coronary artery disease as means of secondary prevention by comparing oral antidiabetic~     therapy with metformin with insulin glargine o.d. and by studying the respective effects on~     cardiovascular function and metabolism both in the fasting state and after a standardized~     meal. As diastolic myocardial function has emerged as important prognosticator, the~     hypothesis was tested that treatment with insulin glargine improves myocardial function in~     patients with coronary artery disease and newly diagnosed type 2 diabetes including impaired~     glucose tolerance.~   "
193139|NCT01035515|"~     The study will examine the effects of a single dose of BIIB014 on blood pressure and~     haemodynamic variables in healthy volunteers over 24 hours.~   "
193140|NCT01035502|"~     The main objective of this study is to assess the biological activity of elacytarabine in~     combination with idarubicin in patients with acute myeloid leukaemia who has failed the first~     course of a remission-induction treatment with cytarabine (ara-C). In addition, the~     correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival~     will be studied.~   "
193141|NCT01035489|"~     In heart failure patients we hypothesised that right ventricular high posterior septum is~     superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we~     prospectively randomized the right ventricular lead placement to find evidence of differences~     in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements~     of reverse remodelling and dyssynchrony.~   "
193142|NCT01035476|"~     This research will examine the utility of the data card recording capacity of nasal~     ventilation devices (NIPPV) in people with ALS to optimize use.~   "
193143|NCT01035463|"~     This phase I/II trial studies the side effects and best dose of lenalidomide when given after~     combination chemotherapy with or without rituximab and stem cell transplant and to see how~     well it works in treating patients with persistent or recurrent non-Hodgkin lymphoma that is~     resistant to chemotherapy. Biological therapies, such as lenalidomide, may stimulate the~     immune system in different ways and stop cancer cells from growing. Drugs used in~     chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them.~   "
193144|NCT01035450|"~     The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent~     is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion~     revascularization at 1-year and death or myocardial infarction at 3-year after stent~     implantation in the real world clinical practice.~   "
193145|NCT01035437|"~     This study aim is to find out what effects capecitabine, oxaliplatin and radiation therapy~     following photodynamic therapy have on esophageal cancer.~   "
193146|NCT01035424|"~     The primary aim of the study is to assess the genotype - phenotype correlations of the CNS~     manifestations of late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal, rare,~     recessive disorder of the CNS in children. This study will be accomplished by comparing the~     genotype to a neurologic assessment and Weill Cornell LINCL scale, the UBDRS scale, the~     standardized CHQ quality of life scale, and the Mullen scale; magnetic resonance imaging~     (MRI); and routine clinical evaluations. This study is designed to run parallel to a separate~     study which is being done by the Department of Genetic Medicine, which will use gene transfer~     to treat the central nervous system (CNS) manifestations of late infantile neuronal ceroid~     lipofuscinosis.~   "
193147|NCT01035411|"~     This clinical study will aid future formulation development and optimisation of AZD9668~     tablets by evaluating possible effects of minor changes to the formulation and process on the~     rate and extent of absorption.~   "
193148|NCT01035398|"~     RATIONALE: Gathering information about genes, cigarette smoking, and diet may help doctors~     learn more about risk factors that may cause esophageal cancer.~      PURPOSE: This clinical trial is studying genetic and environmental risk factors related to~     esophageal cancer.~   "
193149|NCT01035385|"~     This study is a multicenter, open-label, randomized ,controlled phase III study to compare~     preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4~     chemotherapy in patients with resectable liver metastasis from colorectal cancer.~   "
193150|NCT01035372|"~     Dried plums (Prunus domestica L.) have traditionally been recognized for their health~     benefits related to conditions such as constipation, irregular menstrual cycles and mouth~     sores. This dried fruit provides high levels of fiber, vitamins and minerals. Dried plum has~     also been shown in animal studies to have beneficial effects on bone and can prevent the loss~     of bone caused by low hormone levels such as occurs after surgical removal of the ovaries. We~     also have shown that dried plum can prevent the loss of bone associated with aging in mice.~     Very few therapies for osteoporosis actually reverse bone loss and improve bone strength. The~     potential therapeutic value of dried plum in men and women with hormone deficiency or~     age-related osteoporosis is clear.~   "
193151|NCT01035359|"~     Distal radius fractures are treated surgically if severely displaced. This study aims to~     investigate the outcome after surgery. The investigators will randomize patients to either~     external fixation with optional addition of k-wires or open reduction and fixation with a~     volar plate.~   "
193152|NCT01035346|"~     This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared~     to placebo in patients with a fever due to an uncomplicated acute infection.~   "
193814|NCT01026649|"~     To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a~     central venous catheterization compared to the traditional one stage approach on the~     incidence of hematoma formation and success rate.~   "
193156|NCT01035294|"~     The purpose of this study is to evaluate the feasibility and preliminary efficacy of a~     mindfulness-based behavioral intervention combining breathing and other relaxation exercises~     on symptoms of anxiety in patients undergoing the implantation of an implantable cardioverter~     defibrillator. This study will pilot test the feasibility and preliminary efficacy of a~     mindfulness-based intervention intended to improve mindfulness and anxiety levels in ICD~     (Implantable Cardioverter Defibrillators) patients. A randomized controlled study design will~     be used, in which an 8 session phone-delivered mindfulness intervention will be compared to a~     usual care condition among consecutive candidates for ICD procedures. The study will be~     conducted at the Electrophysiology (EPS) Unit at the UMass Memorial Medical Center.~     Assessments will be performed at baseline and at the end of the intervention (9 weeks after~     enrollment).~   "
193157|NCT01035281|"~     Neuropathic pain occurs as a result of damage or disease of the peripheral or central nervous~     system. Regardless of its cause, neuropathic pain (NeP) leads to a characteristic clinical~     picture characterized by ongoing pain with steady or dysesthetic pain, such as burning or~     aching, and paroxysmal pain such as shooting or stabbing. In conditions such as diabetic~     neuropathy, changes in the membrane-bound proteins that form ion channels may alter the~     electrical properties of the injured neuron, called remodeling. The net effect of membrane~     remodeling is greater excitability of neurons, leading to a tendency towards action potential~     generation and propagation in injured primary sensory neurons which occurs in the context of~     nerve injury and disease. Over the past decade, a new endogenous cannabinoid~     receptor-mediated system within the nervous system and upon immune-mediated cells has been~     described. The cannabinoid receptor system consists of two receptors, CB1 and CB2 receptors,~     as well as endogenously produced endocannabinoids which agonize these receptors.~      This is a multicenter trial amongst Western Canadian sites to compare the efficacy of~     nabilone versus placebo in treating patients with chronic neuropathic pain (NeP) due to~     diabetic peripheral neuropathy (DPN).~      A one-week screening period will occur, during which pain scores and sleep scores will be~     tabulated. Following screening, a 4-week period of single blind treatment with flexible~     dosing of nabilone at 0.5 - 4 mg/day will initiate. All subjects will begin with nabilone~     therapy of 1 mg daily for a minimum of 4 days, with the dose of the study medication assessed~     and adjusted either upwards or downwards as needed to balance efficacy for pain control with~     tolerability of possible side effects. All subjects who experience at least a 30% reduction~     in their weekly mean pain score during the single blind flexible dosing phase will be~     considered a responder, and will be further continued in the study. During the double-blind~     portion of the study, subjects randomized to nabilone will continue on the dose of nabilone~     achieved at the completion of the single-blind phase, and this dose will be maintained~     throughout the double-blind phase. Subjects randomized to placebo will receive 1 mg of~     nabilone daily for one week, followed by 4 consecutive weeks of placebo. This dose of~     nabilone will permit a tapering for those subjects achieving a higher daily dose of nabilone~     during the single-blind phase, or will maintain those who were taking only 1 mg per day in~     the single-blind phase, preventing an abrupt termination of treatment in subjects who are~     randomized into the placebo portion of the study.~   "
193158|NCT01035268|"~     This is a phase III randomized multi-center study of equivalence comparing the radiological~     follow-up for patients benefiting from the correction of the esthetical relapse of the~     preservative treatment by fatty transfer compared with a simple supervision.~      It is planned that 440 patients participate in this study which plans to compare 2 groups of~     patients: a group of patients which will benefit from the surgical treatment by transfer of~     fatty tissue and a group of patients under simple supervision.~      follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months,~     12 months and 5 years to look for the expected unwanted effects in relation with the surgery~     but also to estimate the impact of the fatty transfer on the rate of local and\or from a~     distance relapse.~      During these consultations, the surgeon and the patient will also estimate the cosmetic~     result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized~     photos.~   "
193159|NCT01035255|"~     The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity~     and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).~   "
193160|NCT01035242|"~     Over a period of 3 weeks, association splitting is compared to cognitive remediation (CogPack~     training) as an add-on intervention to cognitive-behavioral therapy (CBT). Blind to treatment~     assignment, both groups are assessed before intervention and eight weeks as well as six~     months later with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the~     Obsessive-Compulsive Inventory (OCI-R) and cognitive tests. OCD severity as measured by the~     Y-BOCS total score serves as the primary outcome parameter. It is assumed that association~     splitting will improve OCD severity to a greater extent than cognitive remediation.~   "
193161|NCT01035229|"~     The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC)~     to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after~     sorafenib treatment or who are intolerant to sorafenib.~   "
193162|NCT01035216|"~     This is an open-label, dose escalation study designed to characterize the safety,~     tolerability, efficacy, and pharmacokinetics of GNKG168 in patients with B-CLL that has~     relapsed or is refractory to all prior standard therapy, or for which no standard therapy~     exists.~   "
193163|NCT01035203|"~     The investigators compare the effects of two interventions, an endurance exercise program and~     a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical~     performance of patients with a cancer-related fatigue syndrome. The intervention will be~     carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the~     study.~   "
193164|NCT01035190|"~     HYPOTHESIS:~      Early prophylactic inhalation of Budesonide reduces the absolute risk of developing~     bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age~     (GA) by 10%.~      PRIMARY OBJECTIVE:~      To determine whether inhalation of Budesonide within 12 hours of life improves survival~     without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA.~      SECONDARY OBJECTIVES:~      To determine whether prophylactic inhalation of Budesonide affects neurodevelopment at a~     corrected age of 18-22 months in preterm infants; to determine whether inhalation of~     corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks~     GA, BPD incidence at 36 weeks GA, and the duration of positive pressure respiratory support~     or supplemental oxygen.~      RATIONALE:~      Pre- and postnatal exposure of the developing lung to inflammation is central to the~     development of BPD and the pulmonary inflammatory response in preterms at risk of developing~     BPD is established very early in life. Corticosteroids have antiinflammatory properties and~     early inhalation of corticosteroids may allow for beneficial local effects on the pulmonary~     system prior to the development of a full inflammatory response with a lower risk of~     undesirable systemic side effects.~      STUDY DESIGN:~      Randomised placebo-controlled, multi-centre clinical trial.~      RESEARCH PLAN:~      Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of~     life to Budesonide or placebo to prevent BPD. Study drugs will be administered via~     Aerochamber and continued until infants are either off supplementary oxygen and positive~     pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. The~     primary outcome of survival without BPD will be determined at 36 weeks GA and BPD will be~     defined according to the physiological definition. Study patients will be followed and~     neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months.~      CLINICAL SIGNIFICANCE:~      BPD not only contributes to the mortality of preterm infants but is also associated with~     impaired neurosensory development in Extremely Low Birth Weight (ELBW) survivors, frequent~     readmission to hospital in the first 2 years of life, as well as with an increased risk of~     asthma, lung function abnormalities and persistent respiratory symptoms in adolescence and~     young adulthood. Systemic corticosteroids are effective in preventing BPD, but their use is~     practically prohibited given their adverse effects on neurodevelopment. Early inhalation of~     corticosteroids has been shown to be associated with secondary pulmonary benefits, but its~     effect on survival without BPD and on neurodevelopment remains unclear.~   "
193165|NCT01035177|"~     Numerous geometric and bone mineral density (BMD) parameters can be derived from quantitative~     computed tomography (QCT) images of the proximal femur analyzed using dedicated software. The~     primary objective is to evaluate the contribution of QCT-image analysis to the prediction of~     the osteoporotic hip fracture risk, as compared to the reference standard, namely, dual~     energy X-ray absorptiometry (DXA).~      Study hypothesis: For predicting osteoporotic hip fracture, findings from QCT images of the~     proximal femur analyzed using dedicated software are superior over DXA measurements of~     proximal femoral BMD.~   "
193166|NCT01035164|"~     PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with~     Alzheimer's Disease compared to healthy volunteers.~   "
193167|NCT01035151|"~     The major aim of this study is to test the effectiveness of a bundled, multi-level~     intervention (Sister to Sister) on smoking cessation outcomes in female smokers residing in~     public housing neighborhoods.~      Hypothesis 1.1: As compared to the control group, women receiving the Sister to Sister~     Intervention will have higher 7-day point prevalence quit rates at 6- and 12-months as~     validated by salivary cotinine.~      Hypothesis 1.2: As compared to the control group, women receiving the Sister to Sister~     Intervention will have higher 6- and 12-month prolonged smoking abstinence as validated by~     salivary cotinine.~   "
193168|NCT01035138|"~     The primary objective of the original study was to assess the safety of semagacestat in~     Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the~     efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC~     (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0~     of this study (LFBF).~      Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression~     and was associated with worsening of clinical measures of cognition and the ability to~     perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC~     and LFBF have been amended to continue collecting safety data, including cognitive scores,~     for at least seven months. The CT-Registry will reflect results of analyses from the original~     protocol in addition to those from the amended protocol. Very few participants from LFBC~     rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC~     participants who rolled into LFBF were not analyzed.~   "
193169|NCT01035125|"~     The purpose of this study is to explore the effect of one week inpatient self-management~     program (SMP) in patients with fibromyalgia. The SMP is delivered as group~     education/activities by allied health professionals.~   "
193170|NCT01035112|"~     To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging~     techniques to determine which method best finds and defines breast cancer.~   "
193171|NCT01035099|"~     The purpose of this study is to compare two different ways to administer Letrozole to~     determine their effectiveness in blocking estrogen production during ovarian stimulation in~     patients with breast cancer prior to chemotherapy/radiotherapy so that oocytes or embryos can~     be cryopreserved and patients can possibly achieve a pregnancy after the treatment of breast~     cancer.~      During standard ovulation stimulation, the estrogen levels will exceed normal levels and may~     reach 10 times the normal level for a 2 week period. This may not be desirable in breast~     cancer patients. The study hopes to determine if the investigators can stimulate oocyte~     development in the conventional way and administer different doses of Letrozole as the~     oocytes develop, to keep estradiol levels low, increase the number of oocytes the~     investigators are able to recover, and improve the quality of those oocytes.~   "
193172|NCT01035086|"~     The objective of the conducted study was to determine the efficacy of lupin kernel~     fibre-enriched food (Lupinus angustifolius Boregine) on prevention of risk factors for~     gastrointestinal or cardiovascular diseases.~   "
193173|NCT01035073|"~     The objective of this study is to determine the time course of duloxetine efficacy on the~     symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort~     Syndrome(STDS) via use of 24-hour Actigraph™ measures.~      We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients~     with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement~     in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS~     symptoms which may occur even before the antidepressant effect is observed.~   "
193174|NCT01035060|"~     Due to the rapid aging of the population, sarcopenia is among the greatest challenges facing~     the health care system over the next quarter century. This age-related loss of skeletal~     muscle mass and strength directly contributes to the incidence of functional disability,~     thereby reducing independence and quality of life for the elderly. Despite increasing efforts~     to combat sarcopenia, its etiology remains incompletely described. Subsequently, limited~     progress has been made in developing comprehensive preventative and therapeutic strategies to~     combat the problem. A decreased ability to regenerate skeletal muscle fibers through the~     donation of skeletal muscle stem cells (satellite cells) is thought to contribute to~     sarcopenia. However, the upstream physiological mediators that regulate this impairment are~     poorly delineated.~      Reduced muscle blood flow in advanced age appears to be a significant factor in reducing~     skeletal muscle regenerative capacity, but few data exist to confirm this hypothesis. Thus to~     test this hypothesis we aim to conduct a translational pilot trial which examines~     regeneration in both young and old adults. Furthermore, we aim to determine if muscle blood~     flow and satellite cell number are associated with muscle function. The central hypothesis of~     this proposal is that age-related declines in skeletal muscle angiogenesis and perfusion are~     significant causal factors in age-related losses of skeletal muscle mass. The specific aims~     and hypotheses of the project are as follows:~   "
193175|NCT01035047|"~     Clinical decision units (CDUs) improve resource utilization and are a recommended care option~     by the American College of Cardiology / American Heart Association, but are underutilized in~     non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac~     magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously~     assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic~     process for intermediate risk patients with chest pain. The primary objective of this trial~     is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to~     inpatient care among patients with non-low risk acute chest pain.~   "
193176|NCT01035034|"~     The one-stop hybrid coronary revascularization combines minimally invasive direct coronary~     artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced~     operating room equipped with radiographic capability. This study is to compare 1-year~     clinical outcomes of one-stop hybrid coronary revascularization with percutaneous coronary~     intervention (PCI) in selected patients with multivessel coronary artery disease.~   "
193177|NCT01035021|"~     The aim of this study is to evaluate the success rate, insertion time and complication~     depending on the use of neuromuscular blocking agent when inserting the laryngeal mask airway~     (LMA).~   "
193178|NCT01035008|"~     Confocal laser endomicroscopy (CLE) is a novel and highly promising imaging method for that~     allows in vivo imaging of the mucosal layer at resolution of approximately 1 micron. Cellular~     and sub-cellular structures as well as capillaries and single red blood cells can be~     visualized. CLE is now well established as a highly accurate method for distinguishing~     neoplasia in the gastrointestinal tract lumen via endoscopy. A major new breakthrough is the~     development of sub-millimeter CLE probes that can be passed via an image guided needle (nCLE)~     into solid organs and cysts.~      It is hypothesized that nCLE will help distinguish the benign, premalignant and malignant~     cystic lesions of pancreas by visualizing the cellular lining of the cysts, thereby, avoiding~     unnecessary surgery in patient with benign cysts and guiding to early and effective surgical~     removal of high risk neoplastic lesions.~      A prototype minimal risk nCLE system has been developed that can be passed via standard~     endoscopic ultrasound needles into the pancreas but FDA clearance for in vivo use is not~     expected until late 2010. The investigators propose to evaluate this prototype nCLE system in~     vivo during endoscopic ultrasound (EUS), as an initial pilot study.~   "
193179|NCT01034995|"~     Primary Objective:~        -  To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily,~          and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as~          assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton~          Depression Rating Scale (HAM-D) total score.~      Secondary Objectives:~        -  To evaluate the tolerability and safety of SSR125543 in outpatients with major~          depressive disorder~        -  To evaluate plasma concentrations of SSR125543~   "
193180|NCT01034982|"~     The study is designed to investigate the pharmacokinetic behaviour of the free base~     formulation of AZD9668. The study will compared the relative bioavailability of the free base~     formulation at two different dose levels compared to the tosylate salt formulation.~   "
193181|NCT01034969|"~     The Firazyr® Patient Registry is a prospective, observational study designed to document the~     routine clinical outcomes over time in patients treated with Firazyr® in countries where it~     is currently approved. The data collected will be used to evaluate the safety of Firazyr® in~     routine clinical practice and as a data source for post-marketing investigations.~   "
193182|NCT01034956|"~     Purpose of the study:~      The overall goal of this study is to better understand patient experience with injectable~     facial fillers so that the investigators may provide the best results for their patients. To~     do this, the investigators are administering surveys to approximately 50 patients who have~     been treated by Dr. Anthony P Sclafani, MD, FACS.~      Participation:~      Participants will be asked to complete a brief questionnaire regarding their most recent~     treatment by Dr. Sclafani with a facial injectable filler. All responses will be analyzed~     anonymously.~   "
193183|NCT01034943|"~     Distal radius fractures are treated surgically if severely displaced. This study aims to~     investigate the outcome after surgery. The investigators will randomize patients to either~     external fixation with optional addition of k-wires or open reduction and fixation with a~     volar plate.~   "
193184|NCT01034930|"~     The aim of the investigators study is to compare, in a prospective controlled clinical trial,~     the Locator® System with two other types of stress-breaking retention (Retentive Anchors and~     Magnets) for implant supported overdenture in atrophic edentulous mandible, with the use of~     Straumann Dental Implant System.~   "
193185|NCT01034917|"~     This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot~     clinical trial.~      Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the~     PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same~     approach.~      The aim of the study is to compare the virological efficacy of the etravirine-based regimen~     with standard PI-containing regimen.~   "
193186|NCT01034904|"~     The relevance of the study will be in establishing whether Health Related Quality of Life~     (HRQoL) measures obtained repeatedly during hemophilia care are sensitive to significant~     changes in health or personal circumstances related to the transition from youth to~     adulthood. This may support the future use of HRQoL measures as part of routine care in order~     to identify important changes that are not detectible by other clinical means.~   "
193187|NCT01034891|"~     The purpose of this study is to increase understanding of women who are at high risk for~     developing breast cancer. Data from this group will be collected and entered into a registry.~     This registry serves as a clinical database to support research in prevention, early~     detection and treatment of breast cancer.~   "
193188|NCT01034878|"~     Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell~     carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in~     non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the~     anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC~     patients.~   "
193189|NCT01034865|"~     To identify risk factors for the development and diagnosis of hepatocellular CA in patients~     with chronic hepatitis C and to use the data to ultimately develop an effective screening~     program.~   "
193205|NCT01034657|"~     This study assessed the efficacy and safety of LBH589 as single agent and in combination with~     ESA in red blood cell transfusion-dependent Low and Int-1 MDS patients being either~     refractory to ESA or with a low probability of response. The study had a non-randomized core~     phase followed by a randomized phase.~   "
193259|NCT01033955|"~     Study Design: A, multinational, double blind, placebo-controlled pilot RCT involving 80~     patients in the general ICUs of 30 centres. Most patients will be recruited from within~     Canada; however cases will be recruited from international sites. This study will be~     conducted under the auspices of the Canadian Critical Care Trials Group (CCCTG) and the~     International Forum for Acute Care Trialists (InFACT).~   "
193190|NCT01034852|"~     Specific Aims: The primary objective of this registry is to determine the percentage of~     patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical~     ablation procedure when the patient has a history of failing one or more previous catheter~     based ablations for AF. The first 3 months following surgical ablation will be a blanking~     period; any arrhythmia occurring during this time will not be used to determine success.~      Primary Objectives:~        1. Determine the percent success of surgical ablation for AF at 6, and 12 months both on~          and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF~        2. Record and evaluate all complications associated with the surgical procedure.~      Secondary Objectives:~        1. Evaluate usage of anticoagulants at 6, and 12 months.~        2. Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by~          intra-operative, pre-surgical mapping~   "
193191|NCT01034839|"~     In adults with acute myeloid leukemia, especially those < 60 years of age, high-dose~     cytarabine consolidation therapy has been shown to influence survival, but the appropriate~     dose has not been defined.~   "
193192|NCT01034826|"~     Impaired glucose tolerance is a metabolic state between normal glucose homeostasis and~     diabetes. Previously, prospective studies have shown higher progression rates from IGT to~     diabetes in other country. But There is no prospective-multicenter based reports in Korea.~     Therefore, the purpose of this study is to estimate the progression rates to impair glucose~     regulation and diabetes in the Korean population-based Korea national Diabetes program.~   "
193193|NCT01034813|"~     The purpose of this study is to determine the relationship between cutaneous functional~     unit(CFU)recruitment throughout the available active range of motion of a prescribed joint in~     normal subjects and patients with burn scars. Specifically, this study will determine if~     differences in CFU recruitment exist between normal subjects and individuals with burn scars~     at the dorsal hand, dorsal or volar forearm, or anterior or posterior arm during active range~     of motion of the MCP joint during flexion, or the wrist or elbow during flexion or extension,~     respectively.~   "
193194|NCT01034800|"~     The lack of success in treating substance abuse may be contributed to by a limited~     understanding of the clinical neurobiology of drug abuse. A better understanding of such~     deficits might aid in the development of more relevant pharmacological and psychosocial~     treatment approaches. Thus, the purpose of this study is to test the hypothesis that~     repetitive illicit drug use may be associated with cortical and subcortical structural~     abnormalities, vascular abnormalities, as well as neuropsychological decrements.~     Additionally, a battery of psychological tests are administered to provide information about~     demographics, drug use, neurocognitive measures, and personality structures....~   "
193195|NCT01034787|"~     This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage~     III or IV uveal melanoma who have not received prior immunotherapy. CP-675,206 is thought to~     stimulate patients' immune systems to attack their tumors. CP-675,206 has been shown to~     induce durable tumor responses in patients with metastatic melanoma in phase 1 and phase 2~     clinical studies.~   "
193196|NCT01034774|"~     Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to~     give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to~     determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a~     single dose of ACHN-490 Injection in healthy volunteers.~   "
193197|NCT01034761|"~     Introduction:~      The Beers list identifies medications that should be avoided in persons 65 years or older~     because they are ineffective, pose an unnecessarily high risk, or a safer alternative is~     available. In a recent study, we found a high rate of prescribing of Beers list medications~     to hospitalized patients. At Baystate, 41% of medical patients received at least one Beers~     list drug classified as high severity, meaning it carried a high risk for an adverse drug~     reaction, while 5% received 3 or more. Some Beers drugs have been associated with delirium~     and falls. When compared to Baystate patients who did not receive a high severity medication,~     those who did had an increased risk of mortality (7.8% vs. 5.2%), longer length of stay (5.5~     days vs. 3.9 days) and higher costs ($11,240 vs. 6243).~      Specific Aims:~        1. Quantify the impact of synchronous electronic alerts on physician prescribing of~          high-severity Beers' list drugs to hospitalized patients over the age of 65 years.~        2. Compare physician reactions to each drug-specific alert~      Project Description:~      We will develop a series of clinical alerts in CIS, Baystate's computerized provider order~     entry system, to reduce the use of potentially inappropriate medications among hospitalized~     elders. We will randomize providers to electronic alerts or usual care. Whenever a provider~     randomized to alerts attempts to place an order for a high-risk medication on the Beers list~     and the intended recipient is over 65 years of age, a synchronous alert (i.e. a pop-up)~     will inform the physician about the risks associated with the medication and will propose~     safer alternatives.~      We will collect data on physician ordering and patient outcomes comparing the number of Beers~     list prescriptions from providers receiving electronic alerts to those not receiving alerts.~     Our anticipated outcome is a decrease in inappropriate prescribing during the period when the~     electronic alerts are activated. Other potential outcomes include decrease in length of stay~     and a decrease in falls.~   "
193198|NCT01034748|"~     This is single dose study of radiolabeled [14C]PF-00299804 in healthy male volunteers to~     study the absorption, distribution, metabolism and elimination of PF-00299804.~   "
193199|NCT01034735|"~     The primary objective of the trial was to assess the bioequivalence for two concentrations~     (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH~     freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference.~      Each volunteer received three r hGH treatments, with each treatment being administered as a~     single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of~     wash-out period between successive treatments.~   "
193200|NCT01034722|"~     The aims of this study is:~        1. To investigate the diet influence on size and composition of fat globules in breast milk~          under controlled diet.~        2. To study the changes in globules distribution along one session of lactation and during~          the day.~      Study design:~      Subjects:~      This will be a open label study. Each subject will serve as his own control. Study population~     will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western~     diet and 15 Bedouins.~      Each participant will be nursing a 2-5 months baby. Each participant will sign an informed~     consent. Each participant will be ask to collect 2 milk samples twice a day i.e.- once on the~     first nursing in the morning (in the beginning and at the end of the nursing session), and~     once in the evening on last nursing again, (in the beginning and at the end). Each sample~     will contain 5 ml of milk.~      Participants will be asked to repeat the procedure one month later.~   "
193201|NCT01034709|"~     Subjects with symptomatic CMV infection, who are enrolled in this clinical study, will be~     monitored during antiviral therapy.~   "
193202|NCT01034696|"~     The primary objective of this research project is to estimate the number of patients with~     sarcoma or melanoma attending an outpatients clinic that are in pain or have unmet pain~     needs.~   "
193206|NCT01034644|"~     This study, PRISMS-15 is a single visit, exploratory pharmacogenetic trial and long-term~     follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a~     Subcutaneously in Multiple Sclerosis) trial.~      The aim of this trial is to provide additional data on the driving factors of IFN beta~     response and the long-term outcomes of Rebif® treatment.~      This is a Phase IV trial involving subjects who previously participated in the PRISMS trial.~     To address the trial objectives, a single visit will be performed, at least 3 months after~     the onset of the last relapse.~   "
193207|NCT01034631|"~     The purpose of this study is to determine whether BNC105P in combination with/following~     everolimus is effective in the treatment of progressive metastatic clear cell renal cell~     carcinoma following prior tyrosine kinase inhibitors.~   "
193208|NCT01034618|"~     The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to~     regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic~     controls. The objective of the study is to investigate the optimal dose of such an~     insulinotropic mixture.~   "
193209|NCT01034605|"~     Based upon an increased secretion of gastrointestinal satiety hormones (CCK, GLP-1),~     PinnoThin is hypothesized to be more satiating, and to limit energy intake in humans.~     Therefore, the objective of this study is to investigate whether PinnoThin leads to an~     increase in satiety as determined by VAS ratings? Additionally, does PinnoThin consumed~     during breakfast, in comparison to placebo, in overweight women, lead to a decrease in energy~     intake during an ad libitum lunch?~   "
193210|NCT01034592|"~     This is a single-center, single arm, open-label study of oral lenalidomide monotherapy~     administered to red blood cell (RBC) transfusion dependent adult subjects with~     Diamond-Blackfan Anemia (DBA).~      Primary Objective: To evaluate the erythroid response rate as measured by rate of red blood~     cell transfusion independence [MDS International Working Group (IWG) 2000 Criteria will be~     applied].~      Secondary Objective: 1)To evaluate the tolerability and safety profile of lenalidomide in~     patients with DBA and other inherited marrow failure syndromes 2) To correlate response to~     lenalidomide with biologic surrogates of DBA including ribosomal protein mutation status, ex~     vivo erythroid colony growth, and microarray gene expression~   "
193211|NCT01034579|"~     This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease -~     pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study~     of the REGARD trial.~      The aim of this trial is to provide additional data on the factors influencing interferon~     (IFN) beta response.~      This is a Phase 4 trial involving subjects who previously participated in the REGARD trial.~     To address the trial objectives, a single visit follow-up trial will be performed during~     which a blood sample will be collected.~   "
193212|NCT01034566|"~     RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that~     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause~     less damage to normal tissue in patients with retroperitoneal sarcoma. PURPOSE: This phase I~     trial is studying the side effects and and best dose of proton beam radiation therapy in~     treating patients with retroperitoneal sarcoma.~   "
193213|NCT01034553|"~     RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A~     kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating~     patients with relapsed or refractory multiple myeloma.~   "
193214|NCT01034540|"~     The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid~     ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and~     secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles,~     in subjects with hypertriglyceridemia.~   "
193215|NCT01034527|"~     Females who participate in cutting and landing sports suffer anterior cruciate ligament (ACL)~     injuries at a 2 to 10-fold greater rate than males participating in the same high-risk~     sports. Fifty to 100 percent of ACL injured females will suffer osteoarthritis of the injured~     knee within one to two decades of the injury. External knee abduction moment (LOAD) predicts~     ACL injury with high sensitivity and specificity in female athletes. Control of lateral trunk~     motion (LTM) also predicts ACL injury with similar levels of sensitivity and specificity in~     female athletes. These predictors may be linked, as lateral positioning of the trunk can~     create high knee abduction load via both biomechanical and neuromuscular mechanisms. The~     mechanism of ACL injury in females include high knee LOAD and high LTM, with the majority of~     body weight shifted over the injured limb and the foot positioned lateral to the body's~     center of mass. An unanticipated perturbation is also often a contributor to the injury~     mechanism. LTM may result in increased knee LOAD by increasing the lateral position and~     magnitude of the GRF vector (ΔGRFv) or by increasing reactive hip adductor torque (HAdT). Our~     long-term objectives are to determine the mechanisms that cause ACL injury in female athletes~     and to develop neuromuscular training (NMT) interventions that specifically target these~     mechanisms. If the objectives of this proposal are achieved, an evidence-based NMT~     intervention will be developed and made available nationally that will effectively and~     efficiently reduce ACL injury risk in high-risk female athletes. The major goal of this~     proposal is to determine if increased LTM increases coronal plane knee load in high-risk~     groups of female athletes. This application will test the central hypotheses that LTM~     increases knee LOAD and that NMT that is targeted toward increasing coronal plane control of~     trunk motion will decrease knee LOAD in females with moderate and high knee LOAD. Aim 1 is~     designed to determine the mechanisms by which trunk motion may increase knee LOAD in female~     athletes. Coronal plane control of the trunk (LTM) will be examined relative to ΔGRFv, HAdT~     and knee LOAD. We will determine if increased LTM increases knee LOAD by biomechanical~     (increased ΔGRFv) and/or neuromuscular (increased relative HAdT) mechanisms that may underlie~     increased LOAD in female athletes. The central hypothesis of Aim 1 is that increased LTM will~     increase knee LOAD in female athletes by increasing ΔGRFv, by increasing HAdT or via a~     combination of these mechanisms during cutting and landing. We hypothesize that females with~     neither mechanism will have low knee LOAD, those with increased ΔGRFv or HAdT will have~     moderate LOAD and those with increased ΔGRFv and HAdT will have high knee LOAD. Aim 2 is~     designed to determine if NMT that decreases coronal plane trunk motion will decrease knee~     LOAD in knee load group clusters in a randomized controlled trial. The central hypothesis of~     Aim 2 is that NMT will decrease knee LOAD in the moderate LOAD group by decreasing ΔGRFv or~     HAdT and will decrease LOAD to the greatest extent in the high LOAD group by decreasing both~     ΔGRFv and HAdT.~   "
193216|NCT01034514|"~     To develop and investigate a novel radiotherapy technique for preserving lung function based~     on a map of lung function.~   "
193217|NCT01034501|"~     The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct~     to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological~     and immunological parameters. This is a randomized, controlled, double-blind, parallel~     clinical trial. Thirty eight patients with chronic periodontitis will receive conventional~     periodontal treatment. After eight weeks, patients will be re-evaluated and sites with~     residual pockets (PD ≥ 5 mm ) will be selected as experimental sites, and will be allocated~     to test and control group randomly. The test group will receive the application of PDT and~     the control group will receive sham procedure. The clinical parameters will be evaluated at~     baseline, 3, 6 and 12 months after treatment. Subgingival plaque will be collected before~     PDT, a week after, 3, 6 and 12 months later. The microbiological evaluation will detect and~     quantify periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia,~     Treponema denticola and Aggregatibacter actinomycetencomitans with real time-PCR. During~     follow-up, patients will receive periodontal maintenance every 3 months, as well as the~     application of PDT or sham~   "
193218|NCT01034488|"~     1. Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is~          an endogenous anticoagulant. This complex inhibits the formation of thrombin and~          accelerates its destruction. In addition, heparin and ATIII inactivate other proteases~          of the coagulation cascade, especially the anti-activated factor X. The outcome of these~          biochemical actions is the inhibition of the formation and synthesis of activators of~          the clotting factors that exert critical functions in the genesis of the blood clot.~          Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of~          anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent~          thrombosis.~           Based on clinical studies, the control of plasma heparin level in patients with CRF is~          essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa~          factor to be used as a substrate for protection for those patients undergoing~          hemodialysis.~        2. Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in~          use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having~          as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in~          patients with renal failure who do hemodialysis treatment.~   "
193219|NCT01034475|"~     Chemotherapy resistance is a major cause of death in patients with advanced hematologic~     malignancies. The proposed novel mechanism of action, non-cross resistance with~     chemotherapeutic agents currently used in the clinic, and lack of CPI-613-related~     myelosuppression preclinically and clinically to date make CPI-613 a suitable candidate for~     phase I clinical trial in these patients. The current trial is one of several clinical trials~     of CPI-613. Other clinical trials that are conducted in patients with solid tumors have~     already been initiated.~      The primary objective of this study is to determine the safety and MTD of CPI-613 when~     administered 2x weekly for 3 consecutive weeks.~      The secondary objective is to determine the PKs of CPI-613 following IV administration and to~     observe the anti-tumor effects of CPI-613, if any occur.~   "
193220|NCT01034462|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive~     disorder~   "
193221|NCT01034449|"~     This program offers the opportunity to receive an allogeneic transplant to try to control the~     malignant hematologic in the absence of acceptable conventional donor and with a risk-benefit~     ratio equivalent to that which would be expected with a transplant from a more conventional~     donor.~      An economy of means in that this method could serve as an alternative to 2 units of placental~     blood transplantation. The current cost of disposal of a unit of placental blood from a bank~     is approximately 22000 € (Source: Biomedicine Agency, 2007 rates). The amplification process~     as controlled by EFSAL is 12000 €. Therefore, buying a unit and ex-vivo amplification is~     more economical. Moreover, the availability of placental blood is not infinite, and the use~     of one unit per patient will also save resources that can be valuable for certain groups of~     patients.~      In the longer term, methods of amplification of specific immunocompetent cells (from the~     fraction of CD 34 neg cells) are already being evaluated in the laboratory. They allow to~     consider a faster recovery, better and more targeted, including cells against the disease for~     which transplantation is performed.~   "
193222|NCT01034436|"~     The purpose of this study is to study the health effects of fatty acid quality in healthy,~     overweight individuals.~   "
193223|NCT01034423|"~     The investigators want to study health effects from omega-3 fatty acids, from fishoil with~     different quality.~   "
193224|NCT01034410|"~     This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine~     in the treatment of patients with primary refractory or relapsed acute myeloid leukemia.~   "
193225|NCT01034397|"~     This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging~     (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with~     moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological~     DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg~     (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their~     stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and~     target sample size is <100.~   "
193226|NCT01034384|"~     Background:~        -  Denicotinized cigarettes are similar to commercial cigarettes but contain and deliver~          virtually no nicotine. Denicotinized cigarettes are used as a control condition in~          smoking research, as a substitute treatment for nicotine dependence, and as a strategy~          to reduce incidence of nicotine addiction. However, the symptoms of nicotine withdrawal~          and craving for cigarettes must be minimized to ensure that smokers will continue to use~          denicotinized cigarettes instead of their preferred cigarettes.~        -  Although research has shown that smokers preferred cigarettes that delivered nicotine,~          subjective measures of tobacco craving and withdrawal were similar after standard and~          denicotinized cigarettes. This suggests that the process of smoking and non-nicotine~          components of tobacco smoke mediate some of the effects of cigarette smoking. More~          research is needed on the comparative physical and mental effects of regular cigarettes~          and denicotinized cigarettes.~      Objectives:~      - To compare the effects of complete abstinence or smoking denicotinized cigarettes with~     smoking nicotinized cigarettes on the following measures: (1) withdrawal symptoms and quality~     of sleep, (2) hormonal responses, (3) mood and cognitive performance, and (4) functional~     brain activity.~      Eligibility:~      - Men between 18 and 50 years of age who are either current smokers (at least 15 cigarettes~     per day for at least 2 years) or nonsmoking volunteers.~      Design:~        -  Participants will be divided into four groups: (1) nonsmokers, (2) smokers who receive~          nicotinized cigarettes, (3) smokers who receive denicotinized cigarettes, and (4)~          smokers who will abstain from cigarettes.~        -  The study will last 16 days. Smokers will have 14 visits to the clinical center;~          nonsmokers will have 6 visits. From Day 6 to Day 14, current smokers will follow the~          smoking regimen assigned by the researchers (not smoking, smoking denicotinized~          cigarettes, or smoking nicotinized cigarettes).~        -  Nonsmokers will have one day of training on the memory and thinking tasks that will be~          performed in the functional magnetic resonance imaging (fMRI) scanner, and will have 5~          additional days of two fMRI scans per day (total of 10 fMRI scans).~        -  Current smokers will have 2 days of training on the memory and thinking tasks that will~          be performed in the fMRI scanner, physical assessments on Day 3 and Day 6, and 5 days of~          two fMRI scans per day (total of 10 fMRI scans).~        -  Participants in the complete abstinence group will be asked to resume smoking after the~          abstinence period and the denicotinized cigarettes group will resume nicotinized~          cigarettes on day 14. Participants can decline to resume smoking, and if desired they~          will be referred for smoking cessation treatment.~   "
193227|NCT01034371|"~     The one-stop hybrid coronary revascularization combines minimally invasive direct coronary~     artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced~     operating room equipped with radiographic capability. This study is to compare 1-year~     clinical outcomes of one-stop hybrid coronary revascularization with off-pump coronary~     artery bypass (OPCAB) in selected patients with multivessel coronary artery disease.~   "
193228|NCT01034358|"~     The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been~     shown to prevent the transmission of several strains of HPV in young women. Women with~     inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to~     having IBD or due to immunosuppressants used to control IBD. This study will test how well~     women with IBD respond to the Gardasil vaccine.~   "
193229|NCT01034345|"~     In contrast to calcineurin inhibitors, sirolimus is known to exert remarkable~     tolerance-promoting properties in multiple animal transplant models. Whether sirolimus is~     capable of enhancing tolerance-related pathways and/or promoting complete withdrawal of~     immunosuppressive drugs in human transplant recipients has not been previously addressed. The~     goal of the investigators study is to evaluate the effects of sirolimus on previously~     identified tolerogenic pathways in humans and, indirectly, to assess the capacity of this~     drug to enhance the proportion of liver recipients undergoing successful immunosuppression~     weaning.~   "
193230|NCT01034332|"~     We hypothesize that one-cycle induction chemotherapy may also help to identify~     chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.~   "
193231|NCT01034319|"~     This study will examine the impact diabetes genetic counseling on patient motivation and~     disease prevention behaviors among subjects with pre-diabetes. Intervention subjects will be~     provided with their individual diabetes genotype risk score derived from aggregating the~     combined results of 37 diabetes risk-associated genetic loci. Controls will not be tested.~     All subjects will be enrolled in a 12-week diabetes prevention program.~   "
193232|NCT01034306|"~     This trial will test the hypothesis that the administration of CF101, a novel~     anti-inflammatory agent, to patients with rheumatoid arthritis and high A3AR expression at~     baseline will relieve signs and symptoms of the disease.~   "
193233|NCT01034293|"~     The purpose of this study is to determine the effect of feeding frequency on glucose and~     insulin metabolism and substrate partitioning.~   "
193234|NCT01034280|"~     The purpose of this study is to correlate phenotype and genotype of Down syndrome patients in~     order to identify the biochemical reactions involved in their mental retardation and their~     other phenotypic characteristics.~   "
193235|NCT01034267|"~     The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment~     of adults with major depressive disorder.~   "
193236|NCT01034254|"~     This project is designed to assess the efficacy of immunizing women during pregnancy with~     influenza vaccine on the health of these women during their pregnancy and for 6 months~     post-partum as well as on the health of their newborn infants during the first 6 months of~     life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number~     of large scale randomized trials have been conducted over the past 20 years.~   "
193237|NCT01034241|"~     The purpose of this study is to determine whether different protein diets affects glucose and~     insulin metabolism and substrate partitioning.~   "
193238|NCT01034228|"~     Efforts are continuing to improve the efficacy of oral rehydration solution in terms of~     reducing the severity (stool volume) and duration of diarrhoea (enhancement of recovery).~     Antimicrobial peptides, produced by the epithelial cells, represent an important component of~     the innate immunity of all epithelial surfaces of the body including intestine. Induction of~     expression of antimicrobial peptides on epithelial cell surface, may thus hasten recovery~     from infectious diarrhoea. Isoleucine is an essential amino acid that is easily available and~     not very expensive, and its addition to oral rehydration solution might help early clearance~     of diarrhoeal pathogen by inducing secretion of antimicrobial peptide by the small intestinal~     epithelial cells. Additionally, it is expected to hasten recovery from diarrhoea by~     reestablishing the commensal bacteria. The aim of this pilot study is to assess if addition~     of isoleucine to oral rehydration solution induces secretion of antimicrobial peptide, help~     establish normal bacterial populations in the intestine, and favourably impacts the severity~     and duration of diarrhoea in young children. If the results are found encouraging, a~     therapeutic trial with adequate sample size would be justified.~   "
193239|NCT01034215|"~     Global Objective: To improve quality of life and reduce stress for breast cancer survivors.~     To address the late-term and long-term effects of breast cancer treatment, as defined by the~     Institute of Medicine, including chemo brain, fatigue, sleep deprivation, stress, anxiety,~     depression, and PTSD.~      Phase II Aims: (1) To demonstrate the clinical efficacy (i.e., improved quality of life,~     stress reduction, participant satisfaction with product) of the Envision the Rhythms of~     Life program and (2) to establish the technical merits of the program's distance-delivery~     (videoconferencing hardware and software) and instructional technology (i.e., animations,~     graphically enhanced PowerPoint instructional materials, full-color program manuals,~     art-as-imagery, and audio-imagery). Envision the Rhythms of Life instructs breast cancer~     survivors in the practice of individualized, emotionally supportive, and biologically~     accurate imagery and consists of 5, 4-hour long, interactive classes and between-class~     instructor support.~      Instructional Options: Option 1 delivers the program technology (animations, PowerPoint,~     manuals, art, audio-art) with instructor and participants in the same room. Option 2 delivers~     the program at-a-distance, to a small group of, via videoconferencing software and camera~     systems (Alaska and Seattle) to low, moderate or high bandwidth areas. Each option delivers~     program three times (total of 45 participants for each option). A website portal provides all~     program information and materials.~      Design and Method: Program will be delivered to 135 breast cancer survivors who have~     completed conventional care (surgery, radiation, IV chemotherapy) for at least six weeks.~     Differences in option 1 and 2 outcomes will be compared to each other and to controls;~     combined outcomes of option 1 and 2 will be compared to controls; and waitlist control~     outcomes will be compared to their extended baseline. Hypothesis: Options 1 and 2 will both~     produce significantly better outcomes than waitlist control group.~   "
193240|NCT01034202|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of~     NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers~   "
193241|NCT01034189|"~     We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent~     chemoradiotherapy (TP-CCRT) as the adjunctive therapy before esophagectomy or as a definitive~     CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional~     esophageal squamous cell carcinoma (ESCC).~   "
193242|NCT01034176|"~     Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients~     with persistent viremia (BK virus found in blood) will impair progress to BK virus induced~     kidney damage by significantly decreasing or eliminating BK virus in the blood.~   "
193243|NCT01034163|"~     The primary objective was to provide drug to ongoing patients who were receiving panobinostat~     and to characterize the safety and tolerability of panobinostat in patients with HL after~     achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT)~     with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from~     the original protocol as of an amendment. The original objective was no longer feasible with~     only 41 of 367 patients randomized after the study was halted due to poor recruitment. An~     amendment was written to allow patients on panobinostat to continue their treatment until~     discontinuation/completion criteria were met (patients were unblinded). Therefore, the study~     was completed as per this amendment. No secondary objectives were included for this trial~     from the amendment; this was a change from the original protocol.~   "
193245|NCT01034137|"~     This randomized, double-blind, placebo-controlled study will compare the efficacy with regard~     to sustained remission and safety of tocilizumab and methotrexate, in combination or as~     monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be~     randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate~     (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or~     methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample~     size is 300.~   "
193246|NCT01034124|"~     Similar to the well publicized grapefruit juice effect, ongoing studies are evaluating the~     interaction potential of other dietary substances on drug disposition. This study is designed~     to determine whether the mechanism underlying the enhancement of the anticoagulative effect~     of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A~     secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type~     interaction with midazolam.~   "
193247|NCT01034111|"~     This study will assess, over a 4-week treatment period, the safety and efficacy of the~     addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who~     failed to achieve glycemic control on metformin monotherapy.~   "
193248|NCT01034098|"~     The purpose of this study was to examine the dynamic lung volumes in obese post-menopausal~     women (without hormone replacement therapy) during exercise and their correlations with~     dyspnea.~   "
193249|NCT01034085|"~     Background:~        -  Some people with schizophrenia have problems with their working memory and paying~          attention for extended periods. These difficulties cannot be treated with antipsychotic~          medications or with many standard therapies.~        -  The prevalence of cigarette smoking among individuals with schizophrenia is about three~          times higher than in the general population. Research has shown that nicotine, the~          addictive component found in cigarettes, can help improve attentional and working memory~          performance. Researchers are interested in learning more about whether there may be an~          overlap in the cognitive functions beneficially affected by nicotine and areas of~          dysfunction in individuals with schizophrenia.~      Objectives:~        -  To evaluate the potential of transdermal nicotine to alleviate cognitive deficits in~          schizophrenia, and to determine whether naturally maintained cigarette-smoking, in~          comparison, is an effective self-medication.~        -  To gather preliminary data on genetics that may account for individual and group~          differences in the performance effects of nicotine.~      Eligibility:~      - Current smokers (25 or more cigarettes per week for at least 1 year) between 18 and 55~     years of age who are either healthy volunteers or have been diagnosed with~     schizophrenia/schizoaffective disorder.~      Design:~        -  The study will require five visits to the research center, with an initial screening~          visit, a training session, and three test sessions. Ideally, all visits will occur 1~          week apart.~        -  Training session: Participants will receive training on the types of computerized~          cognitive and attentional behavior tests that will be given during the active portion of~          the study. Participants will also fill out questionnaires on nicotine use and other~          alcohol and drug use.~        -  Test sessions: Participants will be assigned to random groups and will complete tests~          that assess cognitive performance (a) while maintaining their usual smoking behavior,~          (b) after minimal deprivation (3.5 hours without smoking) while wearing a placebo patch,~          and (c) under the influence of a standard nicotine patch. The order of these sessions~          will be different for individual participants.~        -  Participants will provide blood samples throughout the research study for evaluation~          purposes.~   "
193250|NCT01034072|"~     The purpose of this study is to evaluate for iron overload in pediatric oncology and~     transplant patients who have completed their treatment between one to ten years ago.~   "
193251|NCT01034059|"~     The soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) was an established~     biomarker useful for infection in non-neutropenic patients. In this study, we tested sTREM-1~     in the patients with neutropenic fever. Pro-calcitonin (PCT) and C-reactive protein (CRP)~     were also measured. We planned to investigate and explore the role of sTREM-1 in early~     diagnosis of infection in patients with neutropenic fever.~   "
193252|NCT01034046|"~     The purpose of this study is to assess the effectiveness of two different reduced calorie~     diets that have different combinations of carbohydrate, fat, and protein content in 2 groups~     of study participants: insulin sensitive participants and insulin resistant participants. The~     hypothesis of the study is that people with high and low levels of insulin resistance may~     respond differently to different diet compositions in a real-world environment using meals~     that are commonly available.~   "
193253|NCT01034033|"~     The purpose of this study is to try to understand the biology of development of breast,~     ovarian, fallopian tube, peritoneal or endometrial cancer from persons at high genetic risk~     for these diseases. The influence of environmental factors on cancer development in~     individuals and families will be studied. The efficacy of treatments for these diseases will~     be evaluated.~   "
193254|NCT01034020|"~     Background:~      - Many cigarette smokers claim that smoking helps them stay alert and improves their~     concentration, and have reported problems in attention and concentration after quitting~     smoking. Some research has indicated that nicotine can enhance certain aspects of attention~     and memory in humans. However, more research is needed to determine how nicotine affects~     different elements of the brain's ability to pay attention. Knowing which aspects of~     attention are affected by nicotine may help produce new medications and therapies to help~     people successfully stop smoking.~      Objectives:~        -  To investigate the dose-related effects of nicotine on the ability to pay attention in~          smokers and nonsmokers.~        -  To compare the effects of nicotine in smokers and nonsmokers.~      Eligibility:~      - Individuals between 18 and 50 years of age who are either current smokers (at least 15~     cigarettes per day on average for at least 2 years) or healthy, nonsmoking volunteers.~      Design:~        -  The study will consist of one training session and three testing sessions. Each session~          will last about 2 hours.~        -  The training session will introduce participants to the study tests and evaluate their~          tolerance of the two levels of nicotine nasal spray used in the study. Smokers will~          receive the higher dose of nicotine to introduce them to the effects of the spray.~          Nonsmokers will be given first the lower dose of the spray, followed by higher dose at~          least 30 minutes later. Nonsmoking participants who cannot tolerate the higher dose will~          not continue in the study.~        -  At the start of each testing session, smokers will have one cigarette to standardize the~          time of the most recent exposure to nicotine.~        -  During the testing sessions, participants will receive a placebo spray, a lower dose of~          nicotine, or a higher dose of nicotine, and then will be asked to perform tests that~          evaluate mood, attention, and performance.~   "
193255|NCT01034007|"~     An initial feasibility and safety study evaluating the use of autologous tissue engineered~     vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in~     children with single ventricle anomalies.~   "
193256|NCT01033994|"~     Osteoarthritis (OA) is one of the most common diseases affecting the joints, usually those~     that are weight bearing such as the knees. OA is considered to be a disease of the cartilage~     in the joints even though it involves the whole joint, including the bone and synovium (thin~     lining of the joints which produces synovial fluid). With time, more and more of the~     cartilage is destroyed by the disease with inflammation commonly occurring.~      AS902330 is expected to increase the production and development of specific bone cells:~     chondrocytes and osteoblasts (cells that produce and maintain bone and cartilage). This is~     expected to lead to repair and generation of the cartilage, and a narrowing of the space~     width between the knee joints in a selected region of the knee cartilage. The purpose of this~     study is to see how safe treatment with AS902330 is, and to evaluate its effect on the knee~     cartilage. In addition, the study will also measure the effects of AS902330 in the blood,~     which reflect disease activity.~   "
193260|NCT01033942|"~     This is an exploratory mixed-methods research study that compares an efficacious behavioral~     HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention~     combined with a biomedical intervention (PrEP). After completing the 3MV behavioral~     intervention, participants will be randomly assigned to one of three study arms: 1) daily~     FTC/TDF as PrEP, 2) placebo pill control, or 3) no pill control. Behavioral and biomedical~     data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who~     decline to participate will be asked to complete a brief survey about their opinions on PrEP.~     Qualitative interviews will be completed with six study participants and the study~     coordinators at the end of the trial to explore further the issues of trial acceptability and~     feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability~     issues with YMSM who meet all eligibility requirements of the study except for not being age~     18 or older, but are at least 16 years of age.~   "
193261|NCT01033929|"~     The primary objective is to assess the safety of two doses of C-Tb (0.01 and 0.1 µg/0.1 mL)~     when administered intradermally by the Mantoux technique to patients in the acute phase of~     treatment against active TB. The secondary objectives are to assess the immune response of~     two doses (0.01 and 0.1 µg/0.1 mL) of C-Tb from the size of induration and to assess the~     safety of unpreserved C-Tb and C-Tb preserved with 0.5% phenol (local reactions).~   "
193262|NCT01033916|"~     This research study is designed to better understand post-operative complications as related~     to the tightness of blood sugar control. It is also hoped that we may learn that a more~     liberal control of your blood sugars is not inferior to the current strict glucose control.~     Our ultimate goal is to evaluate if there is any change in the rates of complications between~     the two groups. We will be comparing the current strict blood glucose control with a more~     liberal target for blood sugars.~   "
193263|NCT01033903|"~     The main objective of the study is to determine if there is a difference in the number of~     women with a complete miscarriage after 10 days between expectant management versus treatment~     with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage~     before 14 weeks and a gestational sac retained in the uterus.~   "
193264|NCT01033890|"~     ABSTRACT~      Objectives: The aim of this article is to illustrate the possibility of performing a cochlear~     implant with local anesthesia and sedation, the anesthesic technique and the advantages of~     that in comparison to a general anesthesia.~      Materials and method: The investigators describe two successful surgeries done with local~     anesthesia, including the neural telemetry and the conditions the patient presented after the~     surgery, with a very good recovery and no complications during and after the procedure.~      Key words: local anesthesia, cochlear implant~   "
193265|NCT01033877|"~     The clinical trial is a phase III, double-blind, randomised, controlled, multi-centre,~     clinical trial, on the immunogenicity and safety of TdaP vaccine in comparison to Td vaccine~     when given as a booster vaccination to adults who were vaccinated with D, T and wP vaccine~     according to the Danish vaccination programme in their childhood.~      Healthy, adult, female or male volunteers, who completed primary vaccination with diphtheria~     (D), tetanus (T) and whole cell pertussis vaccine (wP), typically during their childhood, is~     the target population.~   "
193266|NCT01033864|"~     This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate~     sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based~     therapy. On the study day patients will take their prescribed medication (either CellCept or~     mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12~     hours after intake of the study medication. Anticipated time on study treatment is 12 hours~     and target sample size is 24.~   "
193267|NCT01033851|"~     Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This~     study measures the efficacy of two different approaches to reducing anxiety and stress. One~     approach uses education, nutrition, exercise, and time management training, and another uses~     mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress~     reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that~     the two approaches will reduce anxiety in individuals with GAD in different ways. We will~     measure changes in stress hormones associated with these changes.~   "
193268|NCT01033838|"~     Laparoscopic anterior resection is a standardized procedure requiring a small muscle split~     incision to retrieve the specimen and to fashion the proximal part of the double stapled~     anastomosis. Most patients can be included within a standardized perioperative care program~     called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a~     complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid~     approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the~     specimen is retrieved within an endobag through the rectum. The anastomosis is created~     intracorporeally using a triple stapled technique. There are no trials available in the~     literature concerning these 2 techniques. Therefore this study will be undertaken to~     establish the role of the 2 surgical procedures and to compare them after short-term~     follow-up.~   "
193269|NCT01033825|"~     To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous~     (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.~   "
193270|NCT01033812|"~     This pilot study is a sub-study of ATN 067. ATN 067 utilizes a cross-sectional research~     design to recruit Latina and African American young women to undergo HIV screening. The~     primary goal of this proposed pilot study, ATN 084, is to explore the feasibility and~     acceptability of index female recruiters identifying and recruiting their past and present~     male sexual partners to undergo HIV screening and complete a one-time ACASI interview. In~     addition, the study will also include female friendship network members who were enrolled in~     ATN 067 and were diagnosed with HIV. These young women will also be asked to recruit their~     past and present male sex partners to undergo HIV screening.~   "
193271|NCT01033799|"~     This single-center, randomized, double-blind and controlled study aims to examine the effect~     of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001~     (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common~     infectious diseases (cumulated number of infections during the intervention period: primary~     criteria), and on immune functions in healthy shift workers. Volunteers received either~     200g/day of tested product (N=500) or control product (N=500) for 3-months, followed by a~     1-month follow-up.~   "
193273|NCT01033773|"~     To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled~     hyperglycemia enables safe and effective glycemic management and reduces emergency room~     re-visits. We assessed hypoglycemia BG < 60mg/dL; change in mean blood glucose and A1C, and~     ED revisits for hyperglycemia.~   "
193274|NCT01033760|"~     The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and~     Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA~     levels in patients with primary HIV-1 infection.~   "
193275|NCT01033747|"~     The purpose of this study is to assess the safety and the effects on liver iron of~     Deferasirox when given for a long treatment period in patients with transfusion dependent~     iron overload.~   "
193276|NCT01033734|"~     This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of~     intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2~     years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10~     doses). For patients whose conditions no longer merit continued iv dosing, therapy may be~     switched to oral Tamiflu to complete their prescribed course of treatment. If medically~     necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days.~     Anticipated time on study treatment is 5 to 10 days.~   "
193277|NCT01033721|"~     Palomid 529 is a dual TORC1/2 inhibitor of the PI3K/Akt/mTOR pathway having broad activity in~     angiogenesis and cellular proliferation. Palomid 529 will be examined to determine if the~     safety, tolerability and pharmacokinetic profile of single ascending doses when administered~     intravitreally or subconjunctivally.~   "
193278|NCT01033708|"~     Definition of the efficacy of NET compared with treatment as usual in the treatment of~     patients with complex traumatic disease (borderline personality disorder (BPD) and~     posttraumatic stress disorder (PTSD)) as assessed by structured clinical interviews.~     Furthermore, to evaluate the sleep, cortisol level and epigenetic differences in the process~     of the specific therapy compared to treatment as usual.~   "
193279|NCT01033695|"~     Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients~     with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer).~     When planning the optimal therapy in patients with upper gastrointestinal malignancies it is~     essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has~     been added to conventional EUS examination and may provide complementary information to~     distinguish benign for malignant lymph nodes.~      The N-stage relates to the treatment choice and the prognosis, and it is therefore of~     particular interest to know the interobserver agreement in operator dependent techniques.~     This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.~   "
193280|NCT01033682|"~     The purpose of this study is to implement and access a newly developed bladder filling~     protocol for patients receiving radiotherapy for rectal cancer using imaging on the treatment~     unit.~   "
193281|NCT01033669|"~     Assessment of the inhalation profiles of four dry powder inhalers in patients with variable~     degrees of lung obstruction~   "
193282|NCT01033656|"~     An open, randomized, parallel-group, comparative, multicentre study. Patients on~     corticosteroids (plus conventional therapy) will be randomized to receive anakinra~     (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin A~     or sulphasalazine. Patients enter the study if considered refractory to corticosteroids~     (prednisolone equivalent ≥10 mg/day) at the time of randomization.~      The randomized phase of the study will be followed by an open-label extension (OLE) phase, to~     follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term~     treatment with anakinra or one of the study DMARDs or a combination of study drugs for~     additional 28 weeks.~   "
193283|NCT01033643|"~     This study will evaluate if MK3614, given in multiple rising doses, is safe and tolerated in~     male subjects with mild to moderate hypertension.~   "
193284|NCT01033630|"~     Atherosclerosis (in particular stroke and heart attack) is the most important health issue in~     modernized society and high blood pressure is an important predisposing factor. Hypertensive~     subjects with other chronic disease such as diabetes mellitus or impaired renal function are~     particularly vulnerable to these atherosclerotic complications in spite of standard~     antihypertensive therapies.~      Danshen and Gegen are commonly used in Chinese materia medica as treatment for cardiac~     symptoms and atherosclerosis-related disorders.~      The objective of this study is to test Danshen and Gegen as an cardiovascular-protective~     adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.~   "
193285|NCT01033617|"~     Following myocardial infarct, cellular therapy is a potential approach to repopulate the~     injured myocardium, to treat heart failure and restore cardiac function. The purpose of this~     study is to assess the safety, feasibility and efficacy of intramyocardial delivery of~     selected autologous CD133+ bone marrow stem cells at time of coronary artery bypass grafting~     in patients with chronic ischemic cardiomyopathy.~   "
193286|NCT01033604|"~     The application of Glyaderm for skin restoration intends to provide a more stable wound~     closure with enhanced pliability and function of the skin and a more favourable scar. The~     dermal substitute would be affordable for widespread application in full thickness skin~     defects and burns.~      Patients with burn wounds or large full thickness wounds will be evaluated before enrollment.~     All burn wounds that are not clearly full thickness on clinical assessment will be treated~     during the first 48 hours with a hydrocolloid paste and covered with a paraffin gauze~     dressing. This hydrocolloid paste combined with paraffin gauze will ensure maintenance of a~     moist wound environment for the first 48 hours prior to assessment by LDI and randomization.~     This is the standard treatment for all burns admitted to the Ghent Burn Centre.~      Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for~     LDI, the burn wounds will be meticulously debrided during dressing changes. LDI is most~     reliable between 48-72 hours. Patients whose burn wounds meet the inclusion criteria, i.e.~     full thickness burns with LDI values < 200 will be randomized to receive either GLYADERM and~     split skin graft versus split skin graft alone.~   "
193303|NCT01033383|"~     This study will investigate whether there is a particular dose of cranberry capsules that is~     effective in preventing the occurrence of urinary tract infections in females at least 65~     years of age or older who live in a nursing home and who have a history of urinary tract~     infections. The Yale research team will be enrolling 80 subjects in total over several~     nursing home locations within Connecticut.~   "
193287|NCT01033591|"~     Quality of life decreases as the heart failure worsens and is one of the biggest worries of~     these patients. Physical exercise has been shown as a safe intervention for people with heart~     failure. Previous studies have tested heterogeneous exercise programs using different QoL~     instruments and reported that the effects on QoL are inconsistent. The aim of this study is~     to evaluate the effectiveness of a new exercise program for people with heart failure~     (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL,~     functional capacity and cardiovascular risk factor control.~   "
193288|NCT01033578|"~     The aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies~     after hepatectomy and thrombectomy for hepatocellular carcinoma (HCC) and portal vein tumor~     thrombosis( PVTT).~   "
193289|NCT01033565|"~     The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in~     4-8 year old children with autism spectrum disorders and sleep problems.~   "
193290|NCT01033552|"~     This is an open-label, single institution, phase II study in patients with epidermolysis~     bullosa (EB). The underlying hypothesis is that the infusion of bone marrow or umbilical cord~     blood from a healthy unaffected donor will correct the collagen, laminin, integrin, or plakin~     deficiency and reduce the skin fragility characteristic of severe forms of EB. A secondary~     hypothesis is that mesenchymal stem cells from a healthy donor will enhance the safety and~     efficacy of the allogeneic hematopoietic stem cell transplant as well as serve as a source of~     renewable cells for the treatment of focal areas of residual blistering.~   "
193291|NCT01033539|"~     The purpose of this study is to determine the effects of a sachet containing Lactobacillus~     Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7,~     14 and 28 days supplementation as well as 14 days wash out compared to the same sachet~     without the probiotic bacteria as placebo control.~   "
193292|NCT01033526|"~     A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel~     groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C)~     in adult patients with a common cold during a two hour in patient phase; and a follow-up~     period of five days of home treatment as required.~   "
193293|NCT01033513|"~     Many older people experience hyperlipidemia and hypertension, but, to date, there is little~     information regarding whether or not medical nutrition therapy (MNT) or therapeutic meals~     have an independent or joint beneficial impact on older people with these diagnoses. This~     report describes a clinical trial in which the investigators directly examined these issues.~     Two key clinical outcome measures include changes in diastolic blood pressure and total~     fasting serum cholesterol. In addition to these clinical outcome measures the investigators~     collected health related quality of life data and data that permitted cost-effectiveness~     analyses.~      The investigators hypothesized that MNT and therapeutic meals would each lead to lower total~     fasting serum cholesterol and lower diastolic blood pressure after the 52-week trial, in~     comparison to individuals who received standard support (commonly available literature on how~     to manage their disease). The investigators also hypothesized that MNT plus therapeutic meals~     would be especially beneficial because of their synergistic effects on the clinical outcomes.~     Although the investigators established no specific hypotheses regarding the potential impact~     of MNT or therapeutic meals on cost of care and quality adjusted life years, the~     investigators were interested in whether MNT or therapeutic meals would be associated with~     these two measures.~   "
193294|NCT01033500|"~     The investigators hypothesize that a calcineurin inhibitor-free, steroid-free, co-stimulatory~     blockade-based immunosuppressive regimen, in combination with a GLP-1 agonist, will reduce~     the islet mass required to achieve and sustain insulin independence following simultaneous~     islet-kidney transplantation.~   "
193295|NCT01033487|"~     PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease.~     This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659~     in patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
193296|NCT01033474|"~     The investigators are going to compare embryo developmental rates of human eggs following~     freezing in two different freezing methods. The investigators are going to compare the~     pregnancy rates following transfer to patients as well.~      Null Hypothesis: The type of vitrification methodology used will not have an impact on the~     following:~        -  Survival rates~        -  Embryonic developmental rates~        -  Pregnancy and implantation rates.~   "
193297|NCT01033461|"~     The study was conducted to investigate the effect of the probiotic L. paracasei LPC 37 alone~     or in combination with a calcium supplement of the human microbiota and further physiological~     parameters.~   "
193298|NCT01033448|"~     This open-label, multi-center study will evaluate the safety and tolerability and the effect~     on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic~     hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24~     weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified~     as slow virological responders will be enrolled in this study in order to receive additional~     24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS~     will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on~     study treatment is 24 weeks. The target sample size is 50-150 patients.~   "
193299|NCT01033435|"~     The current study will investigate chronic hemodialysis patients who were treated in our unit~     with pomegranate juice intake for 1 year - compared to a control group.~      Markers will be taken 3 months after cessation of pomegranate juice intake, for inflammation~     and oxidative stress and Hb A1c.~   "
193300|NCT01033422|"~     This study will test the hypothesis that CF101, administered orally, will reduce intraocular~     pressure in patients with ocular hypertension and/or glaucoma. Eligible patients with~     elevated intraocular pressure will be evaluated and treated by ophthalmologist investigators,~     and will receive either CF101 pills or placebo (dummy) pills twice daily for 16 weeks. Ocular~     pressure, visual fields, and other aspects of safety and effectiveness will be monitored on a~     regular basis.~   "
193301|NCT01033409|"~     In this Phase I clinical study, three recombinant, avirulent Salmonella Typhi (RASV) strains~     each expressing the Streptococcus pneumoniae surface protein, PspA, will be compared as live~     biological vaccine vectors to evaluate safe and tolerable, single, oral dose levels in adult~     subjects.~   "
193302|NCT01033396|"~     PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be~     exposed to pollen and their symptoms observed.~   "
193304|NCT01033370|"~     This study is a single center, non-randomized, open-label, pilot efficacy and safety study~     evaluating the ability of clevidipine IV antihypertensive to rapidly control elevated blood~     pressure (BP) in the setting of an acute aortic emergencies (aneurysm, dissection or other~     aortic disease).~   "
193305|NCT01033357|"~     The purpose of this study is to determine whether the long term use of the experimental~     Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing~     hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).~   "
193306|NCT01033344|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived~     peptide desensitising vaccine, currently being developed for the treatment of cat allergy.~      This study will look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat~     allergic subjects following challenge to cat allergen in an EEC.~   "
193307|NCT01033331|"~     The purpose of this study is to determine if the treatment with valproic acid can increase~     the muscle strength and motor ability of children with spinal muscular atrophy.~   "
193308|NCT01033318|"~     The goal of this study is to identify at least one safe and well tolerated dose of MK1809~     that has similar pharmacokinetic qualities as 100 mg losartan.~   "
193309|NCT01033305|"~     This is a multi-center study in Ireland and United Kingdom to determine the effects, safety~     and tolerability of a drug called CyCol™ in improving mild to moderate ulcerative colitis~     (UC).~      Informed consent will be obtained and following confirmation of eligibility and disease~     assessment, study participants will be randomised (allocated by chance) to take either~     CyCol™, or placebo, orally once every day for four weeks. Study visit assessments will~     include blood and stool tests, physical examinations and flexible sigmoidoscopies (inspection~     of the bowel wall using a flexible camera).~      Half the participants will receive CyCol™ and half will receive placebo. At the end of~     treatment (4 weeks) study participants will be reassessed again and the findings in those who~     received CyCol™ will be compared with those who received placebo. Any side effects~     experienced during the study and the safety of treatment with CyCol™ will also be evaluated.~   "
193310|NCT01033292|"~     The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate~     in platinum-resistant recurrent ovarian cancer patients receiving gemcitabine and~     carboplatin.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
193311|NCT01033279|"~     The purpose of this study is to determine whether self-management of oral anticoagulation~     therapy with warfarin has an effect on patient's quality of life following a specific~     training program led by pharmacists.~   "
193312|NCT01033266|"~     Nasal CPAP will improve cardiopulmonary exercise test (CPET) performance in patients with~     overlap syndrome(COPD and OSA). Nasal CPAP is proven to improve cardiopulmonary exercise~     testing in patients with OSA. The investigators hypothesis is that patients with overlap~     syndrome will have a greater improvement in their cardiopulmonary exercise testing besides a~     possible improvement in their lung function test and airway resistance.~   "
193313|NCT01033253|"~     The objective of this project was to evaluate a population-based, computerized tailored~     intervention that addresses recommended guidelines for three target behaviors related to~     obesity risk: physical activity (at least 60 minutes on at least 5 days per week), fruit and~     vegetable consumption (at least 5 servings of fruits and vegetables each day), and limited TV~     viewing (2 hours or less of TV each day).~   "
193314|NCT01033240|"~     The purpose of this study is to determine the safety and efficacy of CS-1008 in combination~     with sorafenib to sorafenib alone for treating liver cancer. Approximately 160 participants~     will take part in this study at approximately 22 sites (4 in the US, 8 in Japan, and 10 in~     Asia).~   "
193315|NCT01033227|"~     This study will determine if administration of sodium nitrite is safe and can improve small~     vessel blood flow and tissue oxygenation when given as an additional treatment in patients~     with acute vaso-occlusive crisis (pain crisis) associated with sickle cell disease.~   "
193316|NCT01033214|"~     Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget~     thoracic stent graft as an alternative to open surgical repair.~   "
193317|NCT01033201|"~     Lung transplantation is indicated when end-stage lung diseases no longer respond to available~     standard therapy, making life expectancy short and associated with disability. Acute and~     chronic rejection are common complications following transplantation, indicating screening~     bronchoscopies and transbronchial biopsies at three month intervals the first two years, in~     addition to clinically indicated procedures when rejection or infection is suspected.~     Transbronchial biopsies carry associated risks (bleeding, pneumothorax). Chronic rejection is~     characterized by progressive obliteration of distal airways (Bronchiolitis Obliterans-BO-).~     BO requires open lung biopsy for diagnosis. Alternatively, a clinical surrogate~     (Bronchiolitis Obliterans Syndrome), characterized by decline in Forced Expired Volume in 1~     second not explained by acute rejection or infection is used for diagnosis. The new technique~     of confocal endo-microscopy enables sub-surface visualization of tissue in vivo during~     bronchoscopic procedures using a probe-based confocal microscope, integrated to a standard~     endoscope. Bronchiolar and alveolar structures can be visualized at a cellular and nuclear~     level, and these images can be saved and reviewed. This new technology could potentially~     identify acute and chronic rejection, thus offering and alternative to transbronchial~     biopsies. We expect to describe a new alternative to diagnose acute and chronic rejection~     using confocal microscopy images obtained endoscopically, obviating complications of~     transbronchial biopsies.~      Endoscopic confocal endomicroscopy can detect and classify common bronchiolar and alveolar~     pathological conditions in real time. Specifically, we hypothesize that confocal~     endomicroscopy images of bronchiolar and alveolar structures during standard bronchoscopy~     could help to recognize and classify the presence/absence of acute rejection and/or~     bronchiolitis obliterans syndrome in lung transplant recipients. This technology could also~     identify the histological characteristics lung diseases such as interstitial, obstructive or~     vascular end stage lung diseases, and thus lead to more efficient, safer and more accurate~     diagnosis of these lung conditions during routine bronchoscopies.~   "
193328|NCT01033058|"~     This is a retrospective, randomized, parallel, open-labeled, controlled study to find out~     whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin~     treatment compared with routine treatment.~   "
193329|NCT01033045|"~     The purpose of this study is to describe the management of patients with chronic hepatitis C~     and previous treatment failure.~   "
193318|NCT01033188|"~     There has been an increased awareness towards ACL (anterior cruciate ligament) injuries for~     Norwegian teams, particularly in handball and soccer. The reported number of reconstructions~     in Norway ranges from 1500 to 2000 per year, and in the United States from 50,000 to 100,000~     per year, making ACL reconstruction one of the most common orthopaedic procedures performed,~     especially among young, active and healthy individuals. However, reports state that there is~     a subset of patients (10-40%) who remain subjectively and objectively unstable and/or are~     unable to regain prior function. Additionally, it has been reported that degenerative joint~     disease is associated with traditional single-bundle ACL reconstructions in up to 50% of the~     patients in long term follow up studies.~      It is well known that the ACL is composed of 2 functional bundles named after their tibial~     attachments, the anteromedial (AM) and posterolateral (PL) bundles.~      It is believed that the current single-graft, single-bundle technique for reconstructing the~     anterior cruciate ligament does not anatomically reconstruct either one of these bundles.~      In the last two years, the double bundle technique has been introduced and a few clinical~     studies are available, however only a few RCTs.~      Further study is very important to determine if double-bundle ACL reconstructions should be~     performed, if single-bundle reconstructions can be adjusted to better adapt to their~     biomechanical insufficiency in restoring internal rotation torques and valgus moments, and~     also in trying to identify which patients might better benefit from single-bundle versus~     double-bundle ACL reconstructions.~   "
193319|NCT01033175|"~     Hypothesis:~      The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD)~     among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum~     inflammatory markers and plasma erythropoietin do not differ between COPD patients with and~     without ACD and 2. exercise capacity does not differ between COPD patients with and without~     ACD.~      Rationale-Aim:~      ACD is an immune driven disorder, developing in subjects suffering from chronic inflammatory~     diseases. COPD is a disorder very likely to be associated to ACD due to its systemic~     inflammatory dimension. Currently, data on the prevalence of ACD and on the level of~     inflammatory markers which are implicated in the pathogenesis of ACD in COPD subjects are~     limited and controversial. Furthermore, there is no data on the effect of ACD on exercise~     capacity of COPD subjects.~      Based to the aforementioned, this study has three goals:~        1. to determine the prevalence and the epidemiologic characteristics of ACD in a population~          of clinical stable COPD patients~        2. to investigate whether the levels of serum inflammatory markers and of plasma~          erythropoietin differ between COPD patients with ACD and without ACD~        3. to determine potential differences regarding the aerobic exercise capacity between these~          two groups, using the cardiopulmonary exercise testing (CPET).~   "
193320|NCT01033162|"~     The study's aim is to provide information about the clinical and business cases for~     comprehensive interactive cancer communication systems (ICCS) in the context of real world~     use for cancer care.~      This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system.~     Outcomes for this study include amount of ICCS use and women's ratings of cancer information~     competence, perceived social support, and emotional well being. Secondary outcomes will~     include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare~     visits.~   "
193321|NCT01033149|"~     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of~     N-acetylcysteine (NAC) in the treatment on bulimia nervosa.~   "
193322|NCT01033136|"~     To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure~     Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid PTSD and~     panic disorder (PD) in two phases. The second phase of the study will examine the~     effectiveness of MCET-V by comparing it to Cognitive Processing Therapy, a standard PTSD~     treatment.~   "
193323|NCT01033123|"~     The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate~     in platinum-sensitive recurrent ovarian cancer patients receiving gemcitabine and~     carboplatin.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
193324|NCT01033110|"~     Background:~      Despite the well-known benefits of exercise, 64% of the Swiss population do not fulfill the~     public health recommendation of physical activity. A survey of female staff members over 45~     years of age from the University Hospital Zurich at the end of 2003 showed that physical~     inactivity is also prevalent in this population.~      Aim:~      To assess whether inactive women working at a large hospital centre prefer Nordic Walking~     (NW) or a Jogging (J) as a health promotion strategy. (2) To test whether the method chosen~     by the majority improves physical performance, physical activity, body weight and~     composition, and bone mineral density.~      Methods: The investigators will send out a questionnaire to all female staff members at a~     large hospital centre age 45 and older, ask whether they are inactive, and whether they~     prefer Nordic Walking or Jogging as a health promotion strategy. Depending on the preference~     of the majority of the women, the investigators will then ask inactive female staff members~     age 45+ to participate in a 12-months randomized controlled trial comparing training plus~     nutrition education to nutrition education alone. The training will have a 3-month~     building-up phase followed up by an in part unsupervised training of 9 months. All~     participants will receive a lecture on healthy nutrition once a months for 12 months. The~     investigators will assess diet with a food frequency questionnaire at baseline and after 12~     and 24 months.~      The primary endpoint is: physical performance, measured with the 12-minute Coopertest.~      The secondary endpoints are: level of physical activity, body mass index, body composition~     and bone mineral density at the spine and the hip.~      Importance: This project will address the questions which physical activities are preferred~     by inactive women and whether the preferred training improves physical performance, physical~     activity, body mass index, body composition and bone mineral density. In addition, our study~     will explore whether those women who changed their diet in addition to being randomized to~     the training group have an enhanced benefit.~   "
193325|NCT01033097|"~     This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis~     suffering from pruritus, who require systemic treatment of the disease.~   "
193326|NCT01033084|"~     The purpose of this study is to determine whether transcranial direct current stimulation is~     an effective treatment for major depression, when compared (and combined) to sertraline and~     placebo.~   "
193327|NCT01033071|"~     The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil~     plus chlorthalidone, once daily (QD), to olmesartan medoxomil plus hydrochlorothiazide in~     participants with moderate to severe hypertension.~   "
193330|NCT01033032|"~     Doxorubicin has been an integral part of the treatment of women with breast cancer for many~     years. Since amrubicin may have more activity than doxorubicin, as well as less~     cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be~     a priority. In this Phase II study, the investigators propose an evaluation of single-agent~     amrubicin as second- or third-line treatment for women with metastatic breast cancer.~   "
193331|NCT01033019|"~     This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC~     (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a~     treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post~     treatment biopsies, as safety visit one week after final study drug administration (Day 50),~     a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).~   "
193332|NCT01033006|"~     Background and aims:~      Magnetic resonance imaging (MRI) has proved beneficial for presenting anatomy for regional~     anaesthesia and to demonstrate spread of local anaesthetic.~      A new axillary plexus block with a triple injection (1), combining a short axillary catheter~     method with a transarterial axillary block, is now being evaluated with a 3 Tesla MRI. In~     this study, the investigators are investigating MR visualisation of three different block~     techniques and compare the clinical efficacy of the techniques, with the MR findings.~      Patients & Methods:~      After obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult~     patients, scheduled for hand surgery, were included in a randomised, blinded prospective~     study.~   "
193333|NCT01032993|"~     This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve~     muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced~     by some individuals who use statin medications.~   "
193334|NCT01032980|"~     This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted~     A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza~     vaccine) to meet regulatory requirements for post-marketing safety monitoring.~      Primary objective:~      To describe the incidence of serious adverse events and adverse events of special interest~     (AESIs) after HUMENZA or PANENZA administration throughout the study in different age groups.~      Secondary objective:~      To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or~     PANENZA administration in different age groups up to 21 days after the last vaccination.This~     study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted~     A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza~     vaccine) to meet regulatory requirements for post-marketing safety monitoring.~   "
193335|NCT01032967|"~     The aim of this study is to compare outcomes in patients with operable squamous carcinoma of~     the esophagus who have received either surgery or definitive chemoradiation (CRT).~   "
193336|NCT01032954|"~     This is an open-label and phase IV study of full face injections of variable doses of BT-A.~     As it is an open-label and not blind study, both investigator and subjects will know the~     injection local and doses of the study drug. Patients will be randomized into 3 different~     groups. Each group will receive a specific dose according with the indication evaluated by~     the investigator. Six visits will be schedule in this study.~   "
193337|NCT01032941|"~     The investigators will address the hypothesis that portal hypertension is mediated in part by~     bacterial or endotoxin translocation and the production of inflammatory mediators (tumor~     necrosis factor-α (TNFα), etc.). The investigators hypothesize that food supplementation with~     the probiotic product VSL#3 in patients with Child Pugh B/C cirrhosis will have a beneficial~     effect on in portal pressure (as measured by the HVPG) by reducing inflammatory mediators and~     improving systemic and splanchnic hemodynamics.~   "
193338|NCT01032928|"~     Cancers of the head and neck require surgical, radiation, and chemotherapy treatments that~     are intended to cure the disease. These treatments have toxic effects on muscles and~     structures that are necessary to swallow safely and efficiently. The resulting swallowing~     problems (dysphagia) often remain chronic for Veterans and interfere with their ability to~     eat and drink. The cost burden to the VA health system is high. There is an urgent need to~     develop rehabilitative treatments that lessen these burdens. The proposed research is~     designed to test a novel swallowing therapy that includes the coordination of breathing with~     swallowing. Our study will train medically and surgically treated, chronically dysphagic~     Veterans with histories of oropharyngeal cancer in a novel therapy that involves both~     swallowing and respiratory systems. If the therapy is found to be effective, the long term~     goal of the project is to extend the study to a multi-site, clinical trial and test the~     longstanding effect of this treatment compared to other swallowing therapies on swallowing~     function, QOL and cost.~   "
193339|NCT01032915|"~     This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the~     treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic~     immunosuppression.~   "
193340|NCT01032902|"~     This study has been designed to evaluate the performance of the Chembio Diagnostics Systems,~     Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of~     antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or~     plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.~   "
193341|NCT01032889|"~     Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the~     reduction of submental fat (fat below the chin).~   "
193342|NCT01032876|"~     Neonates with a congenital heart defect are often in need of early cardiac surgery. In~     complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without~     deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic~     injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental~     disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex~     operations may contribute to less cerebral damage, but literature is not conclusive on this~     issue.~      Therefore, the investigators will perform a randomised controlled trial comparing DHCA and~     ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological~     outcome.~   "
193390|NCT01032239|"~     To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment~     (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke~     patients with generalized spastic hypertonia who have not reached their therapy goal with~     other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score~     in the lower extremities.~   "
193343|NCT01032863|"~     Study hypothesis:- Benign joint hyper mobility syndrome which persists into adulthood is a~     special type of benign joint hyper mobility which is more likely to predispose to chronic~     musculoskeletal pain.~      Young Indian adults aged between 25 and 40 years who are blood donors or relatives of~     patients admitted as inpatient or presenting to the out patient department, in Amrita~     Institute of Medical Sciences will be enrolled, after excluding the exclusionary criteria.~     They will be assessed for the presence of chronic musculoskeletal pain using a validated self~     filled questionnaire. The primary investigator who will be blinded to their response will~     examine them for the presence of Benign Joint Hyper mobility Syndrome and for tender points~     suggestive of fibromyalgia.~      Primary Objective:- To determine whether chronic musculoskeletal pain is associated with~     Hypermobility among Indian adults.~      Study design:- Cross sectional survey~   "
193344|NCT01032850|"~     This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the~     following:~        -  how effective this combination of study drugs will be in treating HCC~        -  how long subjects respond to these study drugs~        -  what types of side effects can be expected, and~        -  how severe the side effects are~      All subjects in this study will receive:~        -  Sorafenib twice a day by mouth~        -  Capecitabine twice a day by mouth~      Treatment will be given in a 28-day treatment cycle.~      Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days~     1-7 and 15-21 of the cycle~   "
193345|NCT01032837|"~     This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the~     efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the~     safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza~     strain or influenza A are eligible for this study. Patients will be randomized to one of four~     treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg~     (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body~     weight-adjusted for pediatric patients.~   "
193346|NCT01032824|"~     The purpose of this study is to conduct a randomized control trial of a behavioral~     intervention delivered by counselors via telephone to determine if this is an efficacious~     method for improving medication adherence and health-related quality of life for persons who~     are 50 and older and living with HIV/AIDS and other chronic conditions.~   "
193347|NCT01032811|"~     This is a pilot study that will be an exploratory investigation of the rate of occurrence of~     ADHD/S-ADHD in adolescent cancer survivors. The procedures that will be used for identifying~     attention problem symptoms, determining the frequency and severity of such symptoms, and~     characterizing the level of impairment resulting from the symptoms are novel to pediatric~     oncology research.This pilot study will draw from the approach used in traumatic brain injury~     research of post-injury effects to illuminate more clearly the nature of attentional late~     effects experienced by survivors of childhood cancer.~   "
193348|NCT01032798|"~     This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a~     previously reported liposome-encapsulated mepivacaine formulations.~   "
193349|NCT01032785|"~     It is known that the foramen ovale closes in most infants during the first 6 months of life,~     however, most of the important papers in the field concentrated on observing infants with~     murmurs and following those with patent foramen ovale by echocardiography until 6-24 months.~     The purpose of this study is to observe the natural profile of closure of the foramen ovale~     and ductus arteriosus for the first 36 hours after birth. This understanding may help to~     avoid unnecessary treatment and exams for newborns with findings that are natural for their~     stage of development.~   "
193350|NCT01032772|"~     Choices Plus, a randomized controlled study, will determine the efficacy of the Project~     CHOICES intervention plus a referral to an evidence-based smoking cessation program in~     reducing the risk of alcohol- and tobacco-exposed pregnancies.~   "
193351|NCT01032759|"~     Memantine is associated with improvement in pain relief after surgery.~   "
193352|NCT01032746|"~     RATIONALE: Use of a web-based risk assessment tool may help improve screening rates for~     colorectal cancer.~      PURPOSE: This randomized clinical trial is studying personal electronic health records to see~     how well they work in improving screening rates for colorectal cancer.~   "
193353|NCT01032733|"~     Obesity and sedentary lifestyle are associated with physical impairments and biological~     changes in older adults. Weight loss combined with exercise may reduce inflammation and may~     improve physical functioning in older adults who are overweight or obese and sedentary.~     However, the mechanisms by which weight change and exercise influence physical functioning~     and sarcopenia remain largely understudied. ions). In the WL+E group, participants attended a~     group-based weight management session plus three supervised exercise sessions each week~     throughout the entire study. During each exercise session, participants engaged in both~     aerobic activities (i.e., walking) and lower body resistance training of moderate intensity.~     The participants in the educational control group attended monthly health education lectures~     on topics relevant to older adults. It was hypothesized that participants assigned to the~     WL+E intervention would 1) lose a larger amount of weight, 2) improve their physical function~     levels, and 3) reduce levels of oxidative stress and inflammation to a greater degree than~     participants assigned to the Educational Control group. Outcomes are: 1) body weight, 2)~     walking speed (assessed by 400 meter walk test), 3) the Short Physical Performance Battery~     [SPPB], and 4) knee extension isokinetic strength. The objectives of this pilot study are~     fourfold: 1) to demonstrate the feasibility, acceptability, and efficacy of the proposed WL+E~     intervention in a sample of 40 sedentary, obese older adults with impaired physical~     functioning; 2) to examine the biological effects of the intervention on inflammatory~     processes, oxidative stress, apoptosis, sarcopenia, muscle and body composition, muscle~     strength, and functional performance; 3) to determine whether the expected beneficial effects~     of the WL+E intervention on physical functioning are mediated by changes in inflammation,~     apoptosis, and sarcopenia; and 4) to determine the effect size of the WL+E intervention on~     key outcomes and provide the basis for sample size calculations in the planning of a larger~     RCT.~   "
193354|NCT01032720|"~     To determine if ultrasound-guided knee steroid injections are more effective than sham~     ultrasound knee steroid injections for the treatment of osteoarthritis.~   "
193355|NCT01032694|"~     To compare compliance between patients with CAP treated with Azithromycin SR 2.0 g single~     dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric~     treatment of CAP in outpatient clinic practice.~   "
193391|NCT01032226|"~     The purpose of this study is to compare~        -  the non invasive measurement of arterial pressure (CNAP monitor)~        -  with the invasive measurement of arterial pressure (radial artery catheter) during~          induction and maintenance of general anesthesia~   "
193392|NCT01032213|"~     Arterial and venous thrombotic events are the clinical manifestation of postoperative~     hypercoagulability. Altered serum magnesium may play a role in the balance of coagulation. In~     this study, the investigators investigated the effect of magnesium sulphate on the~     postoperative coagulation change in total intravenous anesthesia (TIVA).~   "
193356|NCT01032681|"~     Primary trial objective in this three arm trial is to assess the safety and tolerability of~     EMD 521873, and to determine whether the maximum tolerated dose (MTD) is reached with EMD~     521873 doses of up to 1.5 mg/kg given alone or in combination with fixed, low-dose~     cyclophosphamide (CPA) in patients with metastatic or locally advanced solid tumors or B-cell~     non-Hodgkin lymphoma.~      Secondary objectives are to evaluate pharmacokinetic, immunogenicity, overall and best~     clinical response, changes in tumor marker levels, survival and biological/immune responses~     to EMD 521873. A total of 78 patients are planned. Patients will remain on the dose~     throughout the trial. It is intended to administer 3 cycles (21 d each, or until progression~     or a xxx line therapy becomes necessary.~   "
193357|NCT01032668|"~     Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac~     events in patients with clopidogrel resistance~   "
193358|NCT01032655|"~     Background: Helicobacter pylori infection has been shown to be associated with the~     development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection~     could reduce the occurence or recurrence of these diseases. However, it was estimated that~     15-20% of patients would fail from first line standard eradication therapy and need second~     line rescue therapy. About 15-30% of patient would fail from second line therapy and need to~     be rescued with third line therapy. The commonly used salvage regimens include (1) Bismuth~     based quadruple therapy (combined with ranitidine or PPI plus two antibiotics) (2)~     Levofloxacin or moxifloxacin or rifabutin based triple therapy. However, Bismuth is not~     available in many countries and the administration method is complex. Its usage is limited by~     the high pill number and low compliance rate. In recent years, the concept of sequential~     therapy has been advocated in the treatment of H. pylori infection. The regimen includes a~     PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and metronidazole~     for another five days. The eradication rate in the first line treatment of sequential therapy~     had been reported to be as high as 90%. More importantly, it has been demonstrated that the~     eradication rate among patients with clarithromycin-resistant strains could be as high as~     89%. According to the Maastricht III consensus meeting, it was recommended that~     susceptibility test should be done for patients who failed two treatments. Therefore, we~     aimed to assess the efficacy of susceptibility test driven sequential therapy as the third~     line therapy for those who fail from two standard eradication therapies.~      Methods: This will be a multi-center, open labeled pilot study~        1. Patients:~             -  Open labeled, non-comparative pilot study~        2. Testing for H. pylori infection:~             -  Before salvage treatment:~           either (1) any two positive of CLO test, histology, and culture or (2) a positive~          C13-UBT will be considered as failure of previous eradication treatment EGD with gastric~          biopsy will be done for H. pylori culture and susceptibility test~             -  After salvage treatment: C13-UBT will be used to assess the existence of H. pylori~               after 2nd or 3rd line salvage therapy~        3. Treatment regimens and assignment:~             -  D1-7: Nexium (40 mg, bid), Amolin (1 gm, bid)~             -  D8-14: Nexium (40 mg, bid), Flagyl (500 mg, bid) plus either one of the following~               according to antibiotic susceptibility test (1) Klaricid, 500 mg, bid or (2)~               Cravit, 250 mg, bid or (3) Tetracycline, 500 mg, bid~        4. Outcome Measurement:~             -  Primary End Point: Eradication rate will be evaluated according to Intent-to-treat~               (ITT) and per-protocol (PP) analyses~             -  Secondary End Point: the eradication rate according to antibiotic susceptibility~               before salvage therapy~   "
193359|NCT01032642|"~     The investigators will use a thin catheter for HSG and apply pressure on the cervix with the~     vaginal speculum to prevent leakage of the dye during injection to study the uterine cavity~     and fallopian tubes and reduce the pain as compared to a standard metal cannula.~   "
193360|NCT01032629|"~     The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2~     diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac~     events (MACE). Other objectives include evaluating the overall safety, tolerability, and~     effectiveness of canagliflozin.~      The data from this study will be combined with the data from CANVAS-R study (Study of the~     Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a~     pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing~     requirements for canagliflozin.~   "
193361|NCT01032616|"~     Splanchnic uptake and metabolism contributes significantly to the differences in flux seen~     between the intravenous and intragastric ingestion of certain indispensable amino acids.~      This is the third in a series of studies designed to increase the investigators knowledge of~     the metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed.~     In the initial two studies the investigators established the neonatal parenteral requirement~     of threonine and lysine. In the current study, the investigators will be examining the~     differences in uptake and metabolism of threonine and lysine across the splanchnic bed.~   "
193362|NCT01032603|"~     The purpose of this study is to evaluate the effectiveness of bilateral lateral rectus muscle~     recession versus unilateral lateral rectus recession with medial rectus resection procedures~     for the treatment of basic type and pseudo divergence excess type intermittent exotropia.~   "
193363|NCT01032590|"~     RATIONALE: A personalized Internet-based weight-loss program may help improve the quality of~     life for colorectal cancer survivors.~      PURPOSE: This randomized phase I trial is studying how well an Internet-based program works~     in helping colorectal cancer survivors lose weight.~   "
193364|NCT01032577|"~     The PropR study will evaluate sensing during ventricular fibrillation (VF) in both bipolar~     and extended bipolar configurations, in order to evaluate if both can be used interchangeably~     in caring for patients. In addition, follow up evaluation of R wave amplitude over time would~     allow us to determine whether one configuration is more likely to be associated with change.~     This understanding would be important in selecting the proper configuration at the time of~     implant.~   "
193365|NCT01032564|"~     In obstetric, the investigators can't predict accurately with current means (BISHOP score,~     traditional cervix ultrasonography and fibronectin) the childbirth time and delay.~      If ultrasonography can determine the length, the cervix opening, it can't define its~     flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the~     consistency of the uterine cervix.~      The elastography (elasticity imagery) is an innovating technology. It is a new technology~     currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography~     to measure the tissues answer under pressure.~      Its contribution in obstetric must be estimated to improve patients minimum fare.~      The main target of the investigators study is to estimate the interest of the measure of~     cervix elasticity degree by elastography in prediction of premature birth within a population~     of pregnant women~   "
193393|NCT01032200|"~     RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with~     cancer receiving radiation therapy to the brain.~      PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue~     caused by radiation therapy in patients with primary brain tumors.~   "
193394|NCT01032187|"~     The purpose of this study is to determine if amphotericin B is effective against visceral~     leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate~     which is the current approved drug used for this disease in Brazil.~   "
193395|NCT01032174|"~     The purpose of this study is to compare compliance between patients with Acute Bacterial~     Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with~     Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic~     practice.~   "
193366|NCT01032551|"~     Coronary angiogram (CA) procedures, with and without angioplasty, can be performed via~     vascular access in the wrist (radial artery) or leg (femoral artery). Both radial and femoral~     artery vascular access have their advantages and disadvantages, but neither has yet been~     proven to have superior health outcomes. Often patients are eligible for both access sites~     but are not well informed regarding the potential advantages and disadvantages of each site.~     Vascular access in cardiac catheterization can be considered a grey zone, where the~     benefits and harms may have different levels of significance depending on the individual's~     preferences and values. For example, patients with significant back pain may not prefer the~     femoral approach as it requires the patient to lie flay for an extended period of time~     compared to the radial approach.~      For grey zone health care options, Patient Decision Aids (PtDA) have been demonstrated to~     improve the quality of decision making by significantly improving knowledge of the patient's~     health care options, improving the patient's accurate risk perception, and improving value~     congruence with the chosen options.~      The investigators propose a randomized controlled trial (RCT) to evaluate the decision~     quality impact of a vascular access PtDA compared to usual care in eligible patient's~     undergoing elective CA procedures. If the PtDA is demonstrated to positively impact the~     decision quality of patients prior to CA procedures, it would be an invaluable bedside tool~     to promote patient informed medical decision making.~      Hypothesis:~      The investigators believe that a PtDA, when compared to usual care, will positively impact~     the decision quality and the process of decision making, relating to vascular access options~     in eligible patients undergoing elective CA procedures.~   "
193367|NCT01032538|"~     The objective of this prospective study is to determine (1) the time course of~     patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome~     Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following~     Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and~     daily function during the study period, are of particular interest.~   "
193368|NCT01032525|"~     This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel~     Disease (IBD) not already included to update the database for years 1990-2003. This will give~     us a truly population based study which will add to our knowledge of IBD epidemiology,~     allowing us to compare our rates with the rest of the world. We will be able to provide~     accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. It will have~     special significance because of the relatively stable Monroe County population prior to 2000~     (population in 1970=711,917; population in 2000 = 735,343).~   "
193369|NCT01032512|"~     After surgical treatment, numerous trials using early postoperative enteral or parenteral~     nutritional support have been attempted, in order to reduce morbidity and mortality. Although~     it is difficult to compare among heterogeneous interventions, most of them have not been~     successful, a fact generally attributed to the timing of the intervention. On the other hand,~     nutrients that become conditionally essential under certain stressful circumstances, the so~     called nutraceuticals, have been incorporated into nutritional formulations. Both facts have~     prompted the idea of pre or perioperative nutrition support, using specific formulations~     called immune enhancing formulas, containing arginine, nucleotides, glutamine and omega3~     fatty acids in varying concentrations. The provision of these nutraceuticals prior and early~     after the surgical, and particularly in oncologic surgery, theoretically permits to obtain~     adequate circulating and tissue concentrations for the moment when they are most needed.~     Exclusive postoperative provision of these substances would not be able to replenish depots~     and provide them for an adequate immune response and wound healing after surgery. However,~     regarding the preoperative approach, it is still not know which patients benefit more (less~     or more severely malnourished), which specific nutrient(s) are responsible for the positive~     effects, and the precise timing these nutrients should be provided. The present study aims to~     demonstrate that immune-enhancing formulas are superior to standard enteral products in~     reducing postoperative nutrition-related complications.~   "
193370|NCT01032499|"~     To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils~     or acne.~   "
193371|NCT01032486|"~     The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances~     in Parkinson's Disease patients, after 2 months of treatment.~   "
193372|NCT01032473|"~     Anxiety disorders are among the most common mental disorders in children, affecting~     approximately 1 out of every 10 children and adolescents. Symptoms of anxiety disorders may~     include excessive fear/anxiety/worry, somatic complaints such as headaches and muscle aches,~     and impaired social and family relationships. Some children with anxiety also experience~     sleep problems, however, little is known about the sleep patterns of anxious children. The~     purpose of the study, conducted at Children's National Medical Center, is to examine the~     sleep characteristics of children with Generalized Anxiety Disorder (GAD) compared to a~     control group of children without GAD to see how sleep behaviors and daytime behaviors are~     related.~   "
193373|NCT01032460|"~     It is essential that anaesthetists successfully perform orotracheal intubation in scenarios~     in which intubation is potentially more difficult, such as where the neck is immobilized.~      The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to~     provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.~      These devices may be especially effective in situations where intubation of the trachea is~     potentially difficult.~      The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in~     situations where the cervical spine is immobilized is not known.~      The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC~     to that of the Macintosh laryngoscope, the gold standard device, in patients in which the~     cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.~      Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time~     to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh~     laryngoscope in simulated difficult laryngoscopy.~   "
193374|NCT01032447|"~     Pilot study for assessing the effectiveness of a Navigator program to aid in clinical trial~     participation amongst the Chinese demographic~   "
193815|NCT01026636|"~     This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body~     and removed over time) and safety of a single dose of ceftobiprole in pediatric patients~     undergoing treatment with systemic antibiotics and may be used to guide dosing~     recommendations for ceftobiprole in children.~   "
193375|NCT01032434|"~     Major depressive disorder is associated with several sleep Polysomnograph (PSG) findings: (1)~     impaired sleep continuity; (2) non-REM (NREM) changes; and (3) enhanced rapid eye movement~     (REM) sleep. The first two patterns are common in other psychiatric disorders, while the REM~     pattern is very characteristic in depression, so the phase-advance theory was accepted by~     most of psychiatrists. Many researchers have focused on the biological rhythm to investigate~     the etiological and pathophysiology of depression, and they think depression can be cured if~     its sleep abnormality is ameliorated.~      It is well known that most of antidepressants treat depression through 5-hydroxytryptamine~     (5-HT) neurons. 5-HT also affects the regulation of the sleep-wake cycle and the sleep~     microarchitecture. Many all-night PSG studies have shown tricyclic antidepressants can~     ameliorate the sleep architecture abnormality in depression by producing rapid suppression of~     REM sleep.~      Compared to TCAs, SSRIs are generally less sedating because of its high selectivity for~     serotonin receptors. SSRIs can suppress REM sleep and delay REM latency too, but they~     increase awakenings and reduce SWS at the same time. One PSG study shown sertraline minimally~     increases sleep efficiency and reduces nocturnal wakefulness time, which may benefit~     depressive patients. However, this study compared the sleep architecture before and after 12~     weeks of pharmacotherapy, so the tolerance to the disturbance of sleep architecture in~     antidepressants appears to develop over several weeks of treatment. Sertraline has a greater~     potency against 5-HT reuptake as well as better selectivity for 5-HT reuptake relative to NE~     reuptake than any other SSRIs, and the relative selectivity of sertraline for inhabiting 5-HT~     reuptake relative to DA reuptake is somewhat less than of any other SSRIs. So it has chance~     to exhibit better effect on sleep architecture in depressive patients.~      Finally, it is difficult to be determined that the unique phenomenon of sertraline is its~     genuine characteristics or the tolerance after 12-week treatment, so it is crucial to assess~     the effect of sertraline on sleep architecture in acute treatment. We hypothesized that~     sertraline could suppress the REM sleep, and have little damage to the sleep architecture of~     depressive patient.~   "
193376|NCT01032421|"~     The current study's primary aim is to investigate the association between neuroendocrine~     fluctuations and mood disorders by monitoring mood states over distinct hormonal phases~     during in-vitro-fertilization (IVF) treatment. The secondary goal of this study is to explore~     psychological profiles and coping mechanisms of women undergoing IVF, and to identify the~     ones that are associated with successful psychological adaptation to the process and a~     successful biological outcome.~   "
193377|NCT01032408|"~     This is a phase III, randomized, controlled, open label study with two vaccine regimens. The~     study will assess the relative safety and immunogenicity of vaccine regimens comparing~     adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine~     in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety~     and immunogenicity data with a contemporaneously enrolled control group of age-comparable,~     healthy subjects.~      Because certain individuals may be hypo-responsive to influenza vaccination, additional~     studies with high-risk groups are warranted in order to determine the optimal vaccine~     formulation and dosing schedule for prevention of novel H1N1 virus infection.~   "
193378|NCT01032395|"~     This is a phase III, randomized, controlled, open label study with two vaccine regimens. The~     study will assess the relative safety and immunogenicity of vaccine regimens comparing~     adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine~     in subjects with Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus, and~     to compare safety and immunogenicity data with a contemporaneously enrolled control group of~     age-comparable, healthy subjects.~      Because certain individuals may be hypo-responsive to influenza vaccination, additional~     studies with high-risk groups are warranted in order to determine the optimal vaccine~     formulation and dosing schedule for prevention of novel H1N1 virus infection.~   "
193379|NCT01032382|"~     The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy~     of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in~     subjects with cutaneous leishmaniasis (CL).~   "
193380|NCT01032369|"~     In this randomized case control study we will evaluate the additive effect of psychological~     intervention, i.e CBT-cognitive behavioral treatment in a multi-strategy weight loss program~     composed of physical activity intervention and nutritional programme.~   "
193381|NCT01032356|"~     The purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic~     modality in reducing contracture following surgical treatment of distal radius fractures.~   "
193382|NCT01032343|"~     Skin cancer incidence continues to rise and ultraviolet radiation (UVR) in sunlight is the~     principal cause. Solar UVR can promote cancer development through its ability to suppress the~     immune system. The purpose of this study is to determine whether dietary supplementation with~     omega-3 polyunsaturated fatty acids can protect human skin from UVR-induced~     immunosuppression.~   "
193383|NCT01032330|"~     The present study is being conducted to assess the natural history of intermittent exotropia~     and to establish the effectiveness of occlusion in its treatment.~      Study Objectives:~        -  To determine the effectiveness of occlusion for the treatment of intermittent exotropia~          among patients aged 3 to < 11 years who have baseline near stereoacuity of 400 arcsec or~          better by Preschool Randot stereotest~        -  To determine the natural history of intermittent exotropia among patients aged 3 to < 11~          years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot~          stereotest~   "
193384|NCT01032317|"~     The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic~     Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.~   "
193385|NCT01032304|"~     The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on~     exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD.~     Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and~     quality of life, and the long-term safety of the drug will be assessed.~   "
193386|NCT01032291|"~     The purpose of this study is to determine whether lenalidomide in combination with cetuximab~     is safe and effective in patients with KRAS mutant colorectal cancer.~   "
193387|NCT01032278|"~     The goal of this clinical research study is to learn if certain biomarker testing on blood~     samples can help to detect heart damage that may occur during chemotherapy. Biomarkers are~     chemical markers found in the blood that may be related to heart function. High levels of~     these markers may be linked with heart problems such as heart damage.~   "
193388|NCT01032265|"~     The purpose of this study is to determine whether treatment of female stress urinary~     incontinence using a web-based programme is effective.~   "
193389|NCT01032252|"~     The primary aim of this two-year project for falls prevention is to reduce number of falls~     and fall incidence in community-dwelling people of 65 years and older in the setting of~     general practitioners. In addition a reduction of fall-related injuries, reduction of~     fall-related risk factors and preservation of Quality of Life is to be achieved.~      A second goal of this study is the implementation of standardized assessment for fall risk~     factors as well as building up a network between instructors for fall prevention exercise and~     general practitioners.~   "
193396|NCT01032161|"~     Despite recent advances in postoperative delirium research, the proportion of children with~     postoperative delirium is still high. Although postoperative delirium is a frequent~     complication and is associated with the need for more inpatient hospital care and longer~     length of hospital stay, little is known about risk factors for recovery room delirium (RRD)~     occurred in postanaesthesia care unit. The aim of the study was to determine pre- and~     intraoperative risk factors for the development of RRD among children undergoing non~     cardiovascular surgery.~   "
193397|NCT01032148|"~     The purpose of this study is to find out the effects of a drug called LBH589 when given to~     people with recurrent or refractory Hodgkin or Non-Hodgkin's lymphoma. The safety of this~     drug will also be studied. The participants' physical state, changes in the size of the~     tumor, or state of Hodgkin or non-Hodgkin's Lymphoma, and laboratory findings taken while~     on-study will help the researchers decide if LBH589 is safe and effective.~   "
193398|NCT01032135|"~     1. Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the~          full study sample with regard to treatment engagement over weeks 1-12 and~          cocaine/alcohol use over weeks 1-24.~             -  Hypothesis 1: An intervention that explores several possible treatment options with~               the patient and provides the chosen option (e.g., MI-PC) will produce higher rates~               of treatment engagement than an intervention focused on engagement in IOP only~               (e.g., MI-IOP).~             -  Hypothesis 2: An intervention that explores several possible treatment options with~               the patient and provides the chosen option (e.g., MI-PC) will produce better~               cocaine/alcohol use outcomes than an intervention focused on engagement in IOP only~               (MI-IOP).~             -  Secondary analysis 1: Among the Non-engaged patients, determine rates of selection~               of each of the three options in MI-PC, retention rates within each option, and~               cocaine/alcohol use outcomes in each option.~             -  Secondary analysis 2: Among the Engaged patients, determine rates of selection of~               each of the three options in MI-PC, retention rates within each option, and~               cocaine/alcohol use outcomes in each option.~        2. Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC~          varies as a function of engagement group, with regard to treatment engagement over weeks~          1-12 and cocaine/alcohol use outcomes over weeks 1-24.~             -  Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP~               will be significantly larger among patients in the Non-engaged group than among~               those in the Engaged group.~             -  Hypothesis 2: The predicted main effect on cocaine/alcohol use outcomes favoring~               MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged~               group than among those in the Engaged group.~   "
193399|NCT01032122|"~     The purpose of this study is to determine whether rituximab as an adjuvant therapy in~     clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer)~     2002) melanoma patients is safe and prolongs overall survival and disease-free interval.~   "
193400|NCT01032109|"~     The purpose of this study is to compare 12-month results of two single initial~     treatments—photodynamic therapy with verteporfin alone and this therapy combined with~     intravitreal bevacizumab—for neovascular age-related macular degeneration, not including~     patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular~     degeneration.~   "
193401|NCT01032096|"~     The main objective of this pilot study is to observe and document the range of changes in the~     blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in~     response to the stimulus of Head and Neck cancer~   "
193402|NCT01032083|"~     The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost~     effectiveness of an SSRI antidepressant, citalopram, in the management of persistent negative~     symptoms of schizophrenia over a year.~   "
193403|NCT01032070|"~     This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral~     etoposide in patients with recurrent or refractory pediatric ependymoma.~   "
193404|NCT01032057|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of~     radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter~     period of time, may kill more tumor cells and have fewer side effects. It is not yet known~     which regimen of chemotherapy given together with radiation therapy is more effective in~     treating pancreatic cancer.~      PURPOSE: This randomized phase II trial is comparing the side effects of two regimens of~     gemcitabine and capecitabine given together with radiation therapy and to see how well they~     work in treating patients with locally advanced pancreatic cancer that cannot be removed by~     surgery.~   "
193405|NCT01032044|"~     This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy~     (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).~      It is a randomized controlled outcomes study including patients already treated for Barrett's~     Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure,~     with or without pCLE (2 arms will be considered in this study). The procedures will be~     carried out per standards of practice with appropriately trained physicians.~   "
193406|NCT01032031|"~     There is little information on the effect of oral bioactive compounds on human skin~     clinically despite evidence of a beneficial effect from laboratory studies. The aim of this~     study is to examine the effect of oral bioactive compounds (green tea and vitamin C) on the~     health of human skin by measuring markers of skin health directly and skin nutrient uptake.~   "
193407|NCT01032018|"~     Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who~     have elevated depression (BDI>=15 or BDI>=10 assessed twice over two week period) and who~     continue to meet all of the trial's eligibility criteria will be consented. Through informed~     consent, both arms of the trial will be described with equipoise as to these approaches to~     postACS depression care. Patients who consent to randomization will be enrolled in the~     treatment trial.~      The intervention phase will be 6 months, and hence the final outcome assessments will be~     performed approximately 9 months after the index ACS. Interim measures of depression will be~     obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause~     mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an~     independent medical event adjudication committee using prospective guidelines will be~     employed.~   "
193430|NCT01031719|"~     This is a phase III, randomized, controlled, open label study with two vaccine regimens. The~     study will assess the relative safety and immunogenicity of vaccine regimens comparing~     adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine~     in subjects with Solid Invasive Tumors and to compare safety and immunogenicity data with a~     contemporaneously enrolled control group of age-comparable, healthy subjects.~      Because certain individuals may be hypo-responsive to influenza vaccination, additional~     studies with high-risk groups are warranted in order to determine the optimal vaccine~     formulation and dosing schedule for prevention of novel H1N1 virus infection.~   "
193504|NCT01030744|"~     The broad, long-term objectives are to generate and test hypotheses leading to theories that~     guide improved care of patients with gestational diabetes. The purpose of this chart review~     study is to evaluate the Vanderbilt Gestational Diabetes Self-Management Education Program~     and Quality Improvement Plan in optimizing metabolic control and improving health outcomes~     during pregnancy with gestational diabetes.~   "
193408|NCT01032005|"~     The main objective of the present study is to assess the impact of double fortified salt~     containing iron and iodine on work performance (productivity) of women plantation workers in~     India. Efficacy studies have shown that salt double-fortified with iodine and iron can~     significantly reduce the incidence rates of iron-deficiency anemia (IDA) and~     iodine-deficiency disorders. Double-fortified salt (DFS) can be prepared by mixing~     microencapsulated iron compounds into conventionally iodated salt (Yuan et al, 2008). Iron~     deficiency anemia affects the work productivity and physical activity. Many studies have~     shown that when the individuals with low Hb received iron supplement, their work performance~     improved markedly. Animal studies have demonstrated that iron deficient anemic rats had a~     lower work tolerance as measured by oxygen consumption than the adult rats with normal Hb~     levels (Ohira et al, 1981). Several human studies have demonstrated the effect of iron~     supplementation on endurance capacity and work productivity in women (Zhu and Haas, 1997,~     1998; Edgerton et al., 1979). Many human studies have also examined the possible linkages~     between iron deficiency and concurrent cognitive or behavioral outcomes. Iron supplementation~     effective in reducing iron-deficiency anemia would also result in better behavioral and~     developmental outcome. Many studies found that IDA had a great influence on cognitive~     functions in infants and school children (Lozoff et al., 2003, 1998 and Friel et al., 2003).~     However, studies of IDA and cognitive function in adults are few and controversial.~      This study will assess iron status and physical and mental performance at 2 time points,~     before and after approximately 10 months during which a controlled intervention will take~     place on tea estates at the Panighatta Tea Garden near Siliguri, West Bengal. Subjects will~     be women between 18 and 50 years of age who are actively employed as full time tea pickers.~     The study requires that 2 experimental groups of subjects be identified: a) an experimental~     group that consumes double fortified salt (DFS) containing iron + iodine, and b) a control~     group that consumes only iodized salt (IS).~   "
193409|NCT01031992|"~     Hereditary hemorrhagic telangiectasia (HHT, Rendu-Osler-Weber Syndrome) is associated with~     frequent nosebleeds in the majority of cases. Several reports in the literature support the~     use of antifibrinolytics like Tranexamic acid to reduce nosebleeds. The objectives of the~     study are to test if Tranexamic acid taken orally can~        1. improve anemia (lead to an increased hemoglobin level)~        2. reduce nosebleeds.~   "
193410|NCT01031979|"~     The proposed study has three distinct but related research objectives. The first goal is to~     measure physiological correlates of successful treatment with Prolonged Exposure (PE) therapy~     for posttraumatic stress disorder (PTSD) in veterans of the Iraq and Afghanistan wars.~     Individuals with PTSD often experience elevated heart rates and other objectively measurable~     signs of anxiety when confronted with safe situations that remind them of past dangerous~     situations. We will measure physiological responses and compare the outcomes to patient's~     self reported subjective accounts of symptom improvement on traditional measures of PTSD.~     Developing a way to measure objective gains in symptoms improvement may help researchers who~     are studying ways to improve PTSD treatment. The second goal of the study is to investigate~     if yohimbine, a drug found to promote a specific type of learning, will improve treatment~     outcomes for veterans in PTSD treatment. The third goal is to investigate if ability to get~     used to loud startling audio tones correlates to baseline PTSD pathology and treatment~     outcomes for PE. This goal represents an important step forward in understanding~     characteristics of heritable traits that are related PTSD. It is significant because such~     research may one day lead to the development of individual responder policies that will~     assist patients by individualizing treatment plans based on personal characteristics.~   "
193411|NCT01031966|"~     The purpose of this explorative trial is to collect preliminary data on efficacy and safety~     of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent~     influenza vaccine in hemodialysis patients. The final aim is that of gathering information~     needed for planning a following confirmatory study on the efficacy and safety of Thymosin~     alpha 1 in the same indication.~   "
193412|NCT01031953|"~     RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent~     nausea and vomiting in patients treated with chemotherapy.~      PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to~     see how well it works in treating patients with nausea and vomiting caused by chemotherapy.~   "
193413|NCT01031940|"~     It is essential that anaesthetists successfully perform orotracheal intubation in scenarios~     in which intubation is potentially more difficult, such as where anatomical characteristics~     predictive of difficult intubation are present.~      The CMAC® Laryngoscope is a new intubating device. It is designed to provide a view of the~     glottis without alignment of the oral, pharyngeal and tracheal axes.~      The CMAC may be especially effective in situations where intubation of the trachea is~     potentially difficult.~      The efficacy of this device in comparison to the traditional Macintosh laryngoscope and other~     novel laryngoscopes is not known.~      We aim to compare its performance to that of the Macintosh laryngoscope, the gold standard~     device, in patients with one or more anatomical characteristics predictive of difficult~     intubation.~      The investigators further aim to compare it to the Airtraq® device a device which has been~     shown to be superior to the Macintosh laryngoscope in previous trials.~      The investigators primary hypothesis is that, in the hands of experienced anaesthetists, time~     to intubation would be shorter using the CMAC than using the Macintosh laryngoscope in~     patients with two or more anatomical characteristics predictive of difficult intubation.~      The investigators further hypothesize that the Airtraq® will be superior the CMAC® with one~     or more anatomical characteristics predictive of difficult intubation.~   "
193414|NCT01031927|"~     Several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of~     obsessive compulsive disorder (OCD). Sarcosine, also known as N-methylglycine, is an~     endogenous antagonist of glycine transporter-I (GlyT-I), which potentiates glycine's action~     at the glycine site of N-methyl-D-aspartate (NMDA) receptors. In this 10-week open-label~     trial, we examined the efficacy and safety of sarcosine treatment in OCD patients.~   "
193415|NCT01031914|"~     The purpose of this engineering trial is to develop and validate an algorithm that will~     deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using~     Continuous Positive Airway Pressure (CPAP) therapy. In this trial the investigators will be~     evaluating the algorithm's ability to correctly distinguish between sleep and wake.~   "
193416|NCT01031901|"~     This study is a prospective, randomized, double-blind, placebo-controlled evaluation of the~     safety of a topically applied formulation of rapamycin to cutaneous fibromatous lesions in~     subjects with Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1). Subjects will~     apply either a Polyvinylidene fluoride (PVDF) coating (Skincerity) containing rapamycin or~     the PVDF coating alone nightly to fibromatous lesions for a duration of six months.~      The primary goal of this study is to evaluate the safety of the topical product in patients~     with TSC and NF1. The secondary goal of this study is to evaluate the effectiveness of the~     topical product for treatment of cutaneous fibromatous lesions.~   "
193417|NCT01031888|"~     Topical insulin application has been proved recently to increase corneal reepithelization~     rate over diabetic animals. However, its effectiveness on corneal epithelial wound healing in~     patients who received pars planar vitrectomy (PPV) for diabetic retinopathy and penetrating~     keratoplasty has not been reported. In this study, we plan to perform a prospective~     randomized study to determine the effectiveness of topical insulin as a primary treatment for~     corneal epithelial defect in patients undergoing vitrectomy for diabetic retinopathy and~     penetrating keratoplasty. All patients enrolled in this study have received corneal~     epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic~     retinopathy and penetrating keratoplasty. The patients were randomized into two treatment~     groups. In the control group, the patients receive conventional postoperative eye drops~     including topical steroid, antibiotic and mydriatics. In the experimental group, the patients~     receive topical insulin eye drops in addition to conventional postoperative eye drops. The~     duration for the corneal surface to completely re-epithelize, the incidence of corneal~     complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer,~     corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of~     recurrent epithelial break down after initial epithelization will be compared between these~     two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty~     will be compared separately.~   "
193418|NCT01031875|"~     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating~     patients with or metastatic urothelial cancer or bladder cancer that has relapsed or not~     responded to treatment.~   "
193419|NCT01031862|"~     The purpose of this study is to investigate the use of radiolabeled particulate cholesterol~     administered intravenously in association with albumin, as a method to study reverse~     cholesterol transport (RCT) in humans by analyzing changes in the tracer activity in total~     plasma, lipoproteins and feces.~   "
193420|NCT01031849|"~     The objective is to analyse the changes in the adipose tissue hystological features and the~     adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the~     change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®)~   "
193421|NCT01031836|"~     The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese~     adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1~     cohort of SC doses.~   "
193422|NCT01031823|"~     This study is a pre-test, post-test single group design with follow-up at month three.~     Twenty-four individuals total will participate in this study with 6 participants in each of 4~     cohorts. Participants and their parents will complete pre-test measures including both paper~     and pencil measures and a video-recording to assess the participant's social interaction~     skills and fluency. These adolescents will participate in both group therapy and peer~     generalization sessions once a week over the course of twelve weeks. Upon completion of the~     intervention, participants and parents will complete paper and pencil and video post-test~     measures. Participants will be encouraged to participate in one follow-up session where the~     paper and pencil and video measures will be completed again.~   "
193423|NCT01031810|"~     The primary objectives of the study are to test whether brain Mono Amine Oxidase-A (MAO-A)~     levels are elevated in patients with treatment-resistant major depression, and to explore~     whether MAO-A brain levels predict treatment outcome with Mono Amine Oxidase Inhibitor (MAOI)~     medication in this population.~   "
193424|NCT01031797|"~     QT dispersion can be a useful, simple noninvasive method for the early detection of cardiac~     involvement in SLE patients with active disease. The investigators therefore recommend~     cardiovascular evaluation for every SLE patient with an SLEDAI higher than 10.~   "
193425|NCT01031784|"~     The HEPAR study is aimed at determining the safety of radioactive holmium containing~     microspheres for the treatment of tumors in the liver. These microspheres will be~     administered by infusion in the liver artery using a arterial catheter in the femoral artery.~   "
193426|NCT01031771|"~     The purpose of this study is to correlate the alimentary consistencies and deglutition~     disorders in children with cerebral palsy.~   "
193427|NCT01031758|"~     The purpose of this study is to investigate the use of radiolabeled particulate cholesterol~     administered intravenously in association with albumin, as a method to study reverse~     cholesterol transport (RCT) in humans by analyzing changes in the tracer activity in total~     plasma, lipoproteins and feces.~   "
193428|NCT01031745|"~     Drug use (DU) is a major risk factor for HIV infection in many regions of the world. However,~     as highly active antiretroviral therapy (HAART) has been rolled out in South and South East~     Asia, less than 2% of individuals initiated on HAART were drug users (DUs) or former DUs,~     despite the fact that approximately 20% of HIV infections in the region are ascribed to DU.~     India is home to about 2.4 million HIV-infected individuals. Though, injection drug users~     contribute to only about 3% of all HIV infections in India; it is estimated that there are~     between 168,000 and 1.1 million DUs in India with HIV prevalence about 30%. Novel approaches~     are needed to engage disenfranchised populations in HIV care in lower and middle income~     countries, where the burden of HIV disease is growing. Incentive-based strategies (or~     contingency management) have been shown to be effective in reducing illicit drug use, smoking~     cessation, and weight loss. Short-term pilot studies have also shown that incentive-based~     strategies can improve electronically-monitored rates of adherence to HAART in the US, and a~     recent study in Africa showed that a small incentive approximately doubled the rate that~     individuals returned to learn the results of their HIV test. However, to date there is no~     experience with the use of incentive-based interventions to improve engagement into care and~     risk-reduction among out-of-care HIV-infected DUs in developing world settings. The~     investigators propose to conduct pilot randomized trial comparing a voucher incentive~     strategy to a control condition to improve engagement in HIV care and HIV treatment outcomes~     among out-of-care, treatment-eligible, HIV-infected DUs in Chennai, India. Subjects in the~     incentive arm will be eligible to earn incentive vouchers for 1) initiating HAART at a~     government-sanctioned HIV treatment clinic, 2) adherence to scheduled follow-up visits at the~     HIV clinic, and 3) achieving suppression of HIV RNA. Subjects will be enrolled from a mature~     research venue in Chennai, YR Gaitonde Centre for Substance Abuse-related Research (YRGCSAR),~     which focuses the epidemiology and natural history of HIV in DUs. Preliminary data from this~     pilot study will be used to inform the design of a phase-III study.~   "
193429|NCT01031732|"~     Current Minimally Invasive THR includes: (1) Minimally Invasive Two-Incision THR (MIS-2),~     (2) Minimally Invasive Modified Watson-Jones THR (MIS-WJ). In contrast, mini-incision~     utilizes smaller incision (< 10 cm in definition) to perform the THR which can further be~     divided into mini-anterolateral (Mini-AL) and mini-posterolateral (Mini-PL).The purpose of~     this study is to investigate how MIS THR can affect the results of THR by a prospective~     randomized clinical trial. It is hoped that some new standards could be established for the~     total hip replacement surgery.~   "
193431|NCT01031706|"~     Previous work demonstrated that inhaled hypertonic saline (HS) reduces exacerbation frequency~     and improves lung function in adults with cystic fibrosis (CF). It is unclear, however,~     whether HS will benefit young patients suffering from CF. The investigators propose to~     further support the concept that HS can benefit children with mild CF lung disease by~     performing a relatively short, placebo controlled study of HS in 5-12 year olds, using lung~     function and mucociliary clearance as key outcome measures.~   "
193432|NCT01031693|"~     Background:~        -  Treatment for nicotine addiction is characterized by high rates of relapse. New~          treatment therapies for nicotine addiction are exploring the use of brain scanning~          equipment to control and decrease nicotine and cigarette cravings.~        -  Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain.~          These pulses can change activity in parts of the brain. Researchers are interested in~          determining whether TMS delivered in single pulses can decrease activity in the parts of~          the brain that respond to nicotine craving.~      Objectives:~      - To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in~     cigarette smokers.~      Eligibility:~        -  Individuals 18 years of age and older who are physically healthy and have smoked 10 or~          more cigarettes per day for at least 1 year.~        -  A small group of healthy nonsmoking control subjects 18 years of age and older will also~          participate in the study.~      Design:~        -  The study will involve seven study visits and two follow-up visits. The control~          participants will have only two visits: one with a magnetic resonance imaging (MRI) scan~          and one with TMS to evaluate brain function and response.~        -  Participants will have an initial assessment about tobacco use habits and craving~          patterns, and will provide blood and urine samples before beginning the study.~        -  Participants will have two initial MRI brain scans. The first scan will look at the~          structure of the brain at rest. During the other scan, participants will look at images~          related to and not related to cigarette smoking.~        -  The single pulse TMS sessions (with either actual TMS or inactive [sham] TMS) will be~          held daily for 5 consecutive days. Magnetic pulses will be triggered by~          cigarette-related picture cues and delivered at varying intervals before the participant~          sees a cigarette-related picture. During these testing visits, researchers will ask~          questions related to tobacco use and craving, and collect urine and breath samples for~          further study.~        -  Participants will have two follow-up visits, 1 week and 2 weeks after the TMS sessions,~          to evaluate memory and mood, and will have one final MRI brain scan at the end of the~          study.~   "
193433|NCT01031680|"~     This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight~     and blood pressure, when added to patients existing medications and how it compares with~     their usual treatment without added dapagliflozin. Safety data will be collected and analysed~     to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have~     diabetes, cardiovascular disease and hypertension.~   "
193434|NCT01031667|"~     The purpose of this study is to evaluate the effect of combination therapy with cilostazol~     and probucol on plaque volume and composition change in comparison with cilostazol alone by~     serial intravascular ultrasound and virtual histology.~   "
193435|NCT01031654|"~     The purpose of this research study is to examine marital dynamics related to husband-wife~     reunification following the veteran's return~   "
193436|NCT01031641|"~     Background:~        -  Currently, National Cancer Institute treatment trials use clinical staff reporting to~          monitor adverse side effects. The clinical staff reports draw on items from the Common~          Terminology Criteria for Adverse Events (CTCAE).~        -  Several of the items in the CTCAE can be adapted for use in patient self-reporting of~          side effects. Researchers are interested in developing a patient-reported outcome (PRO)~          approach to the CTCAE.~      Objectives:~        -  To develop questions that can be used to create a patient-reported outcome version of~          the CTCAE (PRO-CTCAE).~        -  To evaluate patient comprehension of and test the usefulness of the PRO-CTCAE questions~          among diverse groups of patients.~      Eligibility:~        -  Individuals 18 years of age and older who are receiving chemotherapy or radiotherapy as~          cancer treatment.~        -  Participants must be able to speak and understand English.~      Design:~        -  Researchers will conduct up to three rounds of interviews with patients currently~          receiving chemotherapy or radiation therapy treatments for cancer.~        -  Participants will be recruited independently from four different clinical treatment~          sites. At least 25 percent of patients will have an educational attainment of high~          school or less.~        -  Each patient will complete a two-part protocol, including a set of PROs that will be~          followed by a series of questions to evaluate patient comprehension, memory, perceived~          clarity, and judgment of the PROs.~        -  The research will be completed in approximately 1 hour, and participants will receive a~          small amount of compensation for their time and participation.~   "
193437|NCT01031628|"~     The purpose of this study is to determine if escalating the dose of imatinib to keep the drug~     blood level at ≥ 1100 ng/ml leads to better outcomes for patients.~   "
193438|NCT01031615|"~     The purpose of this study is to determine the efficacy of the Child and Family Traumatic~     Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder~     (PTSD) when implemented within 30 days of a potentially traumatic event.~   "
193439|NCT01031602|"~     Objectives:~        -  Assess the prevalence and severity of depression and anxiety in underserved and minority~          women seen in the gynecologic oncology clinic at Lyndon Baines Johnson General Hospital.~        -  Assess the prevalence and severity of sexual dysfunction in this patient population.~   "
193440|NCT01031589|"~     The purpose of this study is to examine the safety, local tolerability and pharmacokinetics~     (how drugs are absorbed in the body, how they are distributed within the body and how they~     are removed from the body over time) of a single intramuscular injection (injected directly~     in the muscle) of 300 mg (Panel 1) or 600 mg (Panel 2) of a new long acting form of TMC278.~     In Panel 3, the safety, local tolerability and pharmacokinetics are being studied after three~     successive intramuscular injections (single injection on Day1, single injection on Day15 and~     single injection on Day43) of a selected dose of the same TMC278 LA formulation. The dose of~     Panel 3 will be determined based on the safety, local tolerability and the pharmacokinetic~     results obtained in Panel 1 and 2.~   "
193450|NCT01031459|"~     The purpose of this study is to investigate the clinical status of patients who participated~     in the original pivotal Betaseron study at 20 years after randomized treatment~     initiationStudy end-points include:~        1. Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related~          mortality~        2. EDSS (Expanded Disability Status Scale)~        3. Cognition~        4. Resource use~        5. SPMS (Secondary Progressive Multiple Sclerosis) status~        6. Employment history~   "
193451|NCT01031446|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving cisplatin and~     paclitaxel together with everolimus may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin and~     paclitaxel together with everolimus and to see how well it works in treating patients with~     metastatic breast cancer.~   "
193441|NCT01031576|"~     Osteoarthritis is the result of the degeneration of the cartilage to articulate, being~     currently considered as having an multifactorial cause.The knees are one of the affected~     joints more due to overload that constitutes the main activator or determinative mechanism~     for the development of the illness. Beyond pain it has important reduction of the amplitude~     of movement and the muscular force that causes functional limitation and posture's~     alterations intervening with the activities of daily life. Therefore, the main objective of~     this study will be to characterize the posture's alterations and the electromiographic~     activity in patients with osteoarthritis of knees. For this study 30 citizens will be~     evaluated, 15 with diagnosis of OA of knees unilaterally and 15 healthful citizens, both the~     groups will be of the feminine sex with age between 60 to 80 years. The selected patients~     will answer a questionnaire of personal dates and will have an evaluation fiche, in which~     will be written down: age, index of corporal mass (IMC), index of Lesquene, index WOMAC~     (Western Ontario and Mac Master), personal and familiar date of the diagnosis, antecedents,~     instituted treatments, date of the last x-ray, radiological classification of the~     osteoarthritis according to Scale of Kellgren, electromiographics date and seeming of the~     postural evaluation. For the electromiographic evaluation the activity of the muscles vastus~     lateralis and medial oblique in the isometric contraction maximum volunteer (ICMV) and in the~     march will be analyzed. And for the postural evaluation will be made three photographs in the~     sights previous frontal and sagittal right and left, being that, for the analysis of the~     posturais alterations the program will be used SAPO.~   "
193442|NCT01031563|"~     Background:~        -  Several studies of risk perception have demonstrated a common bias known as unrealistic~          optimism, in which individuals feel they are less likely than other people to experience~          unpleasant or harmful events in their lives, but more likely to experience pleasant or~          beneficial events.~        -  Previous research has indicated that individuals with schizophrenia have less of a sense~          of unrealistic optimism about adverse events than individuals without schizophrenia.~          However, research on risk perception in schizophrenia is sparse, primarily reporting on~          behaviors and decisions in the laboratory that likely are influenced by risk perception.~        -  Risk perception among substance users may be viewed in two separate categories:~          perception of vulnerability to adverse events and perception of vulnerability to~          negative outcomes associated with substance use. Research in both areas has yielded~          mixed results. Researchers are interested in studying the connections among~          schizophrenia, addiction, and risk perception in order to develop better drug use~          prevention and treatment programs for people with and without schizophrenia.~      Objectives:~      - To compare unrealistic optimism bias in people with and without schizophrenia and/or drug~     dependence, and its association with actual risky behavior.~      Eligibility:~        -  Individuals between 18 and 64 years of age who fall into one of the following study~          categories:~        -  diagnoses of both drug dependence (marijuana or cocaine) and~          schizophrenia/schizoaffective disorder~        -  diagnosis of drug dependence only (marijuana or cocaine)~        -  diagnosis of schizophrenia/schizoaffective disorder only~        -  healthy volunteers with no history of drug use or serious mental disorder~      Design:~        -  The study will require a single visit to the research center for a 5- to 6-hour session.~        -  Participants will complete questionnaires on medical and behavioral history, complete~          tests of thinking skills like memory and attention, complete a brief computerized~          decision-making task, and answer questions about risk perception.~        -  Participants will also provide urine samples and breath carbon monoxide measurements to~          test for recent use of tobacco and other substances.~   "
193443|NCT01031550|"~     The objective is to examine the efficacy of isoflurane (inhaled anesthetic gas) to induce~     clinically effective preconditioning in patients undergoing elective hepatic surgery.~   "
193444|NCT01031537|"~     Background:~        -  Infection by tick-borne encephalitis virus (TBEV) is a significant health concern for~          humans in Europe and Asia. A vaccine is available in these regions and in Canada, but~          not in the United States. Research studies in Europe have shown the vaccine to be~          effective in preventing infection among the general population, where disease is~          transmitted either by the bite of an infected tick (most common) or by ingestion of~          contaminated unpasteurized milk or milk products. Persons who work with the virus in a~          research setting, however, have the potential of being exposed in unnatural ways, and~          may come into contact with concentrations of virus higher than those found naturally in~          ticks.~        -  The Food and Drug Administration is investigating the effectiveness of the existing~          vaccine. It is a killed vaccine, which means that it has been treated to ensure that it~          does not contain live agents (bacteria or virus). The manufacturer has tested the~          product for other possible contaminating agents and none have been detected. However,~          there is an unknown but small risk of exposure to undetected contaminating agents in the~          vaccine.~      Objectives:~        -  To test the safety and immune response to a vaccine against tick-borne encephalitis~          virus (TBEV).~        -  To add a level of protection to persons who may have occupational exposure to TBEV to~          reduce their chances of developing infection from that exposure.~      Eligibility:~      - Individuals 18 years of age or older who are in generally good health and have the~     potential for occupational exposure to TBEV at one of the two National Institute of Allergy~     and Infectious Diseases campuses.~      Design:~        -  Subjects receiving the full series of the vaccine will receive at least three doses by~          injection in the upper arm. The first and third dose of study vaccine will be given in~          the muscle of the nondominant arm. The second dose will be given in the dominant arm.~        -  Participation will include at least 12 scheduled visits to the study center over~          approximately 3.5 years.~        -  An initial visit will take place 7 to 21 days prior to the first injection. Blood~          samples will be taken to test liver and kidney function, baseline antibody levels, and~          for possible pregnancy in female participants.~        -  Doses will be given on days 0, 14, and 161. Participants will be asked to complete a~          diary card on each day for one week following the vaccination to assess any reactions or~          side effects. At each visit after receipt of a vaccine, participants will be asked about~          any side effects.~        -  Blood will be drawn 14 days after the second injection and 21 days after the third~          injection in order to measure the level of antibodies and overall response to the~          vaccine.~        -  Subjects who develop a sufficiently high level of antibodies may (at the discretion of~          the laboratory chief) be allowed to work with strains of TBEV at Biosafety Level (BSL) 3~          rather than BSL-4. Blood will be drawn annually for 3 years to determine antibody level~          and response to the vaccine. Booster doses will be provided if required.~   "
193445|NCT01031524|"~     Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized~     to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or~     ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers~     are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum.~     The main outcome will be the length of time between artificial challenge and development of~     blood stage parasitaemia detected by microscopy performed twice a day.~   "
193446|NCT01031511|"~     Cognitive Behavioural Therapy is an effective intervention program for children with~     High-Functioning Autistic Spectrum Disorder to remediate anxiety issues.~   "
193447|NCT01031498|"~     The goal of this clinical research study is to compare the effectiveness of 3 drug schedules~     in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous~     leukemia (AML) or high-risk myelodysplastic syndrome (MDS).~   "
193448|NCT01031485|"~     The purpose of this study is to investigate the effects of bioactive milk peptides on blood~     pressure in mildly hypertensive subjects.~   "
193449|NCT01031472|"~     This is a single-center, randomized, two part, open-label, crossover study in healthy adult~     subjects to assess the effect of up to three formulations on the relative bioavailability of~     GSK2248761 100mg administered with and without food. Part A will evaluate two new~     formulations compared to the current formulation. Part B will evaluate one additional~     formulation if the bioavailability of the two formulations in Part A do not meet~     pre-specified criteria. Safety evaluations and serial PK samples will be collected during~     each treatment period. A follow-up visit will occur 7-10 days after the last dose of study~     drug.~   "
194055|NCT01023503|"~     The present project is aimed at describing the statins prescription pattern in Spanish~     patients. It will also look into how adequate these prescriptions are accordingly to the~     recommendations given in Treatment Guidelines and in the Summary Product Information.~   "
193452|NCT01031433|"~     Background:~        -  The prevalence of cigarette smoking among individuals with schizophrenia is noticeably~          higher than in the general population, and smoking cessation attempts frequently are~          unsuccessful in this population. Little is known about the effects of cigarette/nicotine~          craving in individuals with schizophrenia. Researchers are interested in learning more~          about how craving affects people with schizophrenia and developing new ways to treat~          cravings and improve the effectiveness of smoking cessation therapies and treatments.~        -  In recent years, virtual reality (VR) has been studied to determine whether it can be~          used to induce craving by using life-like cue settings. VR cues involving cigarette use,~          including images of cigarettes and scent cues of tobacco smoke, may be used to elicit~          craving in smokers. Researchers are interested in learning more about how individuals~          with schizophrenia respond to specific VR cues and settings.~      Objectives:~        -  To determine the feasibility of using a contextual real-world paradigm using virtual~          reality involving cigarette smoking in people with schizophrenia.~        -  To examine if virtual reality cues will elicit craving in smokers with schizophrenia.~      Eligibility:~      - Current smokers (five or more cigarettes per day for at least 1 year) between 18 and 45~     years of age who have been diagnosed with schizophrenia/schizoaffective disorder.~      Design:~        -  The study will involve three sessions, with an initial screening visit, a test session,~          and a follow-up session.~        -  Screening visit: Participants will be screened with a medical and psychiatric history,~          and will answer questions about smoking history, current smoking habits and craving~          patterns, and general anxiety levels. This session will also introduce participants to~          the operation and use of the VR equipment. Participants who are comfortable using the VR~          system will return within 2 days for the test session.~        -  Test session: Participants will use the VR equipment to view neutral scenes and scenes~          that are designed to elicit cravings for cigarettes. After viewing each scene,~          participants will answer questions about their overall mood, anxiety levels, and any~          cigarette cravings they may have.~        -  Follow-up session: Participants will return 1 week after the VR session to answer~          questions about mood, anxiety levels, and current smoking habits and craving patterns.~   "
193453|NCT01031420|"~     Standard treatment for early stage bladder cancer is chemotherapy with methotrexate (M),~     vinblastine (V), adriamycin (A), and cisplatin (C) followed by surgical removal of any~     remaining cancer and the bladder with the intent of cure. The MV chemotherapy is usually~     given every 14 days with the AC given along each 28 days. This study looks at giving the same~     drugs at the same doses closer together, all drugs every 14 days, with the support of growth~     factor medication to promote growth of the white blood cells and platelets and allow~     chemotherapy to be finished sooner and surgery to be done sooner.~   "
193454|NCT01031407|"~     Background:~        -  Autism spectrum disorders (ASDs) are a group of developmental disorders that affect~          communication, social interaction, and behavior. Relatively little is known about the~          relationship between genetics and behavior among these individuals and their close~          relatives. Researchers are interested in using interviews and rating scales to better~          understand these issues, as well as collecting brain scan data and genetic samples for~          testing and comparison.~        -  By comparing test results and genetic samples from healthy volunteers, people with ASD,~          and parents (or caregivers or legal guardians) of the first two groups, researchers hope~          to better understand the neuroscience of ASD.~      Objectives:~        -  To learn more about the brain in healthy people and in people with autism spectrum~          disorders.~        -  To study genes that might be involved in autism spectrum disorders by collecting DNA~          samples from participants.~      Eligibility:~      The following groups of participants will be eligible for the study:~        -  Individuals between 5 and 89 years of age who have autism spectrum disorders.~        -  Healthy volunteers between 5 and 89 years of age.~        -  Cognitively impaired children between 5 and 17 years of age.~        -  Parents/caregivers/legal guardians of individuals in the above three groups.~      Design:~        -  Participants will visit the National Institutes of Health Clinical Center for research~          tests, which will be administered over multiple visits. Researchers will determine the~          specific tests to be administered based on the medical history of the study participant.~        -  Researchers will study the brain through interviews, tests of thinking and memory~          (neuropsychological tests), brain imaging with magnetic resonance imaging (MRI), and~          magnetoencephalography (MEG).~        -  The study will also collect blood or saliva to obtain a DNA sample.~   "
193455|NCT01031394|"~     The objective of this study is to provide insight into the effects combined training~     frequency has on improving fitness, ease of physical activity, and maintenance of a high~     total energy expenditure. Such information is critical to our understanding of ways to~     improve well-being, quality of life, and independence of an aging population. 105~     participants will be enrolled in this study. The length of time for your involvement in the~     study will be 32 weeks. You will undergo the procedures listed in this consent form on 3~     separate occasions-initially at your entry, at 16 weeks and again at 32 weeks.~   "
193456|NCT01031381|"~     This study will investigate the efficacy as well as the safety of RAD001 in combination with~     bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be~     taken orally once daily and bevacizumab will be administered once every 14 days. The study~     will be conducted over a period of about 3 to 4 years.~   "
193457|NCT01031368|"~     This phase I trial is studying the safety and potential efficacy of infusing non-human~     leukocyte antigen (HLA) matched ex vivo expanded cord blood progenitors following treatment~     with clofarabine and cytarabine for patients with acute myeloid leukemia (AML). The~     combination of clofarabine, cytarabine (Ara-C) and granulocyte colony-stimulating factor~     (G-CSF) has been tested in earlier studies for the treatment of acute myeloid leukemia. In~     these previous clinical trials, this combination of drugs has been shown to have an~     anti-leukemia effect. However, the combination of clofarabine and Ara-C is profoundly~     myelosuppressive and immunosuppressive causing periods of neutropenia potentially lasting~     more than three weeks. During this period, patients are at increased risk of infections that~     can result in an increased risk of death. G-CSF is a growth factor that is used to help the~     white blood cells recover more quickly, but even with G-CSF, the use of clofarabine and Ara-C~     is often limited by the need to take long breaks between treatments to allow blood counts to~     recover. In our lab we have developed a method of growing or expanding blood stem cells~     (cells that give rise to the blood system) from umbilical cord blood. We are doing this study~     to find out if giving these expanded cells after chemotherapy is safe, helps the blood system~     recover more quickly from chemotherapy to allow shorter breaks between treatments, and~     decreases the risk of infection~   "
193458|NCT01031355|"~     Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of~     one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium~     as compared to one film-coated tablet containing 3 mg Estradiol Valerate Investigation of the~     bioequivalence of levomefolate calcium after administration of one film-coated tablet~     containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one~     film-coated tablet containing 0.451 mg levomefolate calcium~   "
193459|NCT01031342|"~     Study hypothesis is that performing early colonoscopy in patients who present to the hospital~     with lower GI bleeding improves their outcome.~      Patients who are admitted with bleeding from their rectum and a negative endoscopic exam of~     the stomach and upper intestine are randomized (like flipping a coin) to receive a~     colonsoscopy either as an emergency (within 12 hours) or as a routine procedure (36 hours~     after admission). Patients are followed during their hospitalization to see if they have~     further bleeding, if they require blood transfusions, if they need other diagnostic tests, if~     they need surgery or other treatments, and how long they stay in the hospital.~   "
193460|NCT01031329|"~     The purpose of this study is to identify and characterize the bacteria causing complicated~     Acute Otitis Media episode in children >= 3 months to < 5 years in Turkey.~   "
194056|NCT01023490|"~     The objective of this study is to check whether vitamin D will lead to a decrease in pain~     intensity compare to placebo, in patients suffering from chronic pain.~   "
193461|NCT01031316|"~     The ductus arteriosus directs blood away from the pulmonary circulation and toward the~     systemic circulation during fetal life, then closes after birth. In preterm infants the~     incidence of spontaneous closure decreases with gestational age. Patent ductus arteriosus~     (PDA) increases the risks of bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis~     (NEC). However, this association may not be a causal relationship.~      Echocardiography is required to diagnose PDA. However, routine screening echocardiograms lead~     to detection of asymptomatic PDAs, for which the benefit of therapy remains unproven.~      A randomized controlled trial has been designed in which 88 infants with birth weight less~     than or equal to 1250 grams and gestational age less than or equal to 30 weeks will be~     enrolled. The investigators' goal is to determine how screening echocardiography influences~     clinical management and outcomes in these infants.~   "
193462|NCT01031303|"~     The purpose of this study is to provide further immunogenicity and safety information of~     sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and~     6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi~     pasteur DTacP-IPV// PRP~T vaccine (PENTAXIM™) as a three-dose primary and booster~     vaccinations.~      Primary Objective :~        -  To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio~          types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis~          antigens (Pertussis toxoid [PT], Filamentous Haemagglutinin [FHA]) of sanofi pasteur's~          DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of~          age.~      Secondary Objectives :~        -  To describe the antibody persistence in terms of anti-pertussis antibody levels~          (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria,~          Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose~          (at Visit 1) in all subjects at 4-6 years of age.~        -  To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio~          types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis~          antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after~          administration of the booster dose given at 4 to 6 years of age.~        -  To describe the safety after the booster dose of the study vaccine.~   "
193463|NCT01031290|"~     Background:~        -  Cannabis, also known as marijuana, is a commonly abused drug. There is no approved~          medication to treat cannabis addiction. The desire to use cannabis often increases when~          seeing others use it or seeing pictures of it. Researchers are interested in determining~          which parts of the brain are active when looking at pictures associated with cannabis.~        -  Repetitive transcranial magnetic stimulation (rTMS) uses magnetic pulses to stimulate~          the brain. These pulses can change activity in parts of the brain. Researchers are~          interested in determining whether rTMS can decrease activity in the parts of the brain~          that respond to cannabis, and thereby lessen cravings for cannabis.~      Objectives:~      - To determine whether transcranial magnetic stimulation can lower craving for cannabis when~     people who use cannabis are shown images that increase craving.~      Eligibility:~      - Individuals 18 years of age and older who are physically healthy and currently use cannabis~     (at least 3 times weekly for the past 2 years).~      Design:~        -  The study will involve eight visits over 3 weeks, with each visit lasting 1 to 2 hours.~        -  Participants will have an initial assessment about cannabis use and provide blood and~          urine samples before beginning the study.~        -  Participants will have three magnetic resonance imaging (MRI) brain scans. The first MRI~          scan will look at the structure of the brain at rest. During the other two scans,~          participants will look at images related to and not related to cannabis use.~        -  The rTMS sessions (with either actual TMS or inactive [sham] TMS) will be held daily for~          5 consecutive days. During these testing visits, researchers will ask questions related~          to drug use and craving, and collect urine and breath samples for further study.~        -  Participants will have two follow-up visits, 1 week and 2 weeks after the rTMS sessions,~          to evaluate memory and mood, and one final MRI brain scan at the end of the study.~   "
193464|NCT01031277|"~     The purpose of the study is to establish the proportion of patients on lipid-lowering~     pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004~     NCEP ATP III guidelines, overall and by country, to establish the proportion of patients on~     lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP~     III/updated 2004 NCEP ATP III in the following sub-populations:~        -  Primary/secondary prevention patients.~        -  Patients with metabolic syndrome (according to NCEP III definition). And to establish~          the proportion of patients on lipid-lowering pharmacological treatment reaching the~          LDL-C goals according to the Third Joint European Task Force guidelines/national~          guidelines, in the survey population and in the following sub-populations:~             -  Primary/secondary prevention patients.~             -  Patients with metabolic syndrome.~   "
193465|NCT01031264|"~     Alcoholism is among the top three causes of preventable death and disease in the US (Mokdad~     et al., 2004; Room et al., 2005). Stress plays an important role in the development of~     alcoholism and in high vulnerability to alcohol relapse. This study will provide a greater~     understanding of the mechanism by which stress and alcohol consumption interacts to influence~     development of compulsive alcohol seeking and vulnerability to stress-induced drinking, and~     the results will have significant implications for the development of new prevention and~     treatment interventions for alcoholism.~   "
193466|NCT01031238|"~     The goal of this clinical research study is to learn if using the PEMFlex Solo II, a~     high-resolution camera for positron emission tomography (PET) scan imaging, on an area of the~     body that has, or is suspected to have cancer will give researchers the same or better~     information about the disease compared to the images taken with a routine PET/computed~     tomography (CT).~      Researchers will compare the images taken using the PEMFlex Solo II to the images taken~     during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s),~     magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within~     the last 30 days or may have in the next 30 days.~   "
193467|NCT01031225|"~     This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage~     IIIB or IV non-small cell lung cancer (NSCLC).~   "
193468|NCT01031212|"~     This phase I trial is studying the side effects and best dose of an investigational drug~     called DMXAA (5-6-dimethylxanthenone-4-acetic acid) or ASA404 when given together with~     carboplatin, paclitaxel and cetuximab to treat patients with refractory solid tumors.~   "
193469|NCT01031199|"~     PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with~     Multiple Sclerosis compared to healthy volunteers~   "
193470|NCT01031186|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male~     volunteers~   "
193471|NCT01031173|"~     The study will evaluate the safety and efficacy of Replagal® (agalsidase alfa) at a dose of~     0.2 mg/kg infused intravenously (IV) over 40 minutes, every other week. The study will~     monitor the course of disease in males and females with Fabry disease who are naive to~     treatment or were previously treated with agalsidase beta (Fabrazyme®).~   "
193472|NCT01031160|"~     NEXT is a seven-year longitudinal assessment of a representative sample of U.S. adolescent~     and young adults starting at grade 10. The goals of the NEXT longitudinal study include: to~     identify the trajectory of adolescent health status and health behaviors from mid-adolescence~     through the post high school years; to examine individual predictors of the onset of key~     adolescent risk behaviors and risk indicators during this period; to identify genetic,~     personal, family, school, and social/environmental factors that promote or sustain positive~     health behaviors; to identify transition points in health risk and risk behaviors and changes~     in family, school, and social/environmental precursors to these transitions, and to examine~     the role of potential gene-environment interactions in the development of health status and~     health behaviors. .~      This study collects reliable and valid data on health behaviors and health indicators and~     their social, environmental, and biological contexts beginning with a nationally~     representative probability cohort of 10th-grade children in the U.S in 2009 and following~     them through 2016. Measures are collected annually for seven years beginning in the 2009-2010~     school year and ending in the 2016-2017 school year. African-American youth are oversampled~     to provide better population estimates of this group and to provide an adequate sample to~     examine racial/ethnic differences in longitudinal predictors of health, health behaviors, and~     health behavior change. Hispanic youth do not require oversampling because they currently~     represent a sufficient proportion of the population of adolescents to provide an adequate~     sample to examine racial/ethnic differences. Self-reports of health status, health behaviors,~     and health attitudes are collected by in-school and online surveys. Anthropometric data,~     genetic information, and neighborhood characteristics are gathered on all participants as~     well. The study also incorporates an Administrator Survey and other data sources to obtain~     related information on school-level health programs and community-level contextual data. The~     NEXT Generation Health Study data support NICHD, National Heart, Lung and Blood Institute~     (NHLBI), National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and~     Alcoholism (NIAAA) and the Maternal and Child Health Branch of the Health Resources and~     Services Administration (HRSA/MCHB) in fulfillment of program requirements that address~     supportive health environments for adolescents and young adults. In addition, a~     representative subsample of overweight and normal weight adolescents has been identified:~     additional data on behavioral risk factors and biological markers and risk factors are~     gathered on these adolescents. Driving performance will also be evaluated in 150 young~     adults.~   "
193473|NCT01031147|"~     The Chinese Cerebral Aneurysms Survey is a continuing prospective study to evaluate the~     effectiveness of unenhanced, three-dimensional time-of-flight magnetic resonance angiography~     (3D-TOF-MRA) with volume rendering (VR) at 3-T in the detection of intracranial aneurysms.~   "
193474|NCT01031134|"~     Shared decision-making (SDM), in contrast to traditional medical decision-making, involves a~     collaborative process where patients discuss personal values and preferences and clinicians~     provide information to arrive at an agreed upon treatment decision. The proposed study will~     evaluate the impact of a brief SDM nursing intervention among elderly, depressed primary care~     patient subjects in comparison to physician recommended Usual Care. The focus of the SDM~     intervention is to empower depressed patients and help them arrive at a treatment decision~     that can be successfully carried out.~   "
193475|NCT01031121|"~     Background:~        -  Self-report and biochemical verification are used to determine smoking status in~          treatment trials and clinical research. Each method has merits and limitations that make~          it appropriate for particular situations. Participants who feel social pressure to~          report tobacco abstinence may provide unreliable self-reporting results. Biochemical~          verification using breath carbon monoxide (CO) is a more reliable indicator, but several~          biological and environmental factors (including exposure to secondhand smoke) can affect~          the sensitivity and specificity of breath CO measurement.~        -  An ideal biomarker of smoking status is cotinine, the major metabolite of nicotine.~          Cotinine levels found in blood, urine, and saliva can be used to distinguish between~          smokers and nonsmokers, as well as between light and heavy smokers. Researchers are~          interested in using cotinine assessments to develop suitable breath CO cutoff levels to~          categorize different types of smokers and nonsmokers for use in future research.~      Objectives:~      - To determine a breath carbon monoxide (CO) cutoff level that optimally discriminates~     between heavy and light smokers and nonsmokers who are and who are not exposed to~     environmental tobacco smoke.~      Eligibility:~        -  Individuals between 18 and 64 years of age who fall into one of the following groups:~        -  current smokers reporting more than 10 cigarettes per day for at least 6 months~        -  current smokers reporting 10 or fewer cigarettes per day for at least 6 months~        -  nonsmokers reporting regular environmental exposure to tobacco smoke~        -  nonsmokers reporting limited or no exposure to tobacco smoke~      Design:~        -  The study will involve a single outpatient session.~        -  Participants will provide breath CO, urine, and saliva samples, and will complete~          several smoking-related questionnaires on smoking history, current craving levels, and~          perceived level of nicotine dependence.~   "
193476|NCT01031108|"~     The primary purpose of this study is to evaluate the safety and tolerability of SRT2104 (2.0~     g administered once daily for 28 days) and to examine the effects of SRT2104 (2.0 g~     administered once daily for 28 days) on reversing vasomotor and fibrinolytic dysfunction in~     both type 2 diabetes mellitus patients and otherwise healthy cigarette smokers in a fed~     state.~      This study will investigate the effects of SRT2104 on the reduction of platelet activation~     markers (platelet-monocyte aggregates), and to evaluate the effects of SRT2104 on platelet~     and monocyte surface markers (P-selectin, CD11b), inflammatory markers (high sensitivity CRP,~     IL-6, SAA, TNF-α and sCD40L), and markers of oxidative stress (urinary and plasma~     F2-isoprostanes and nitrotyrosine).~      Further goals of this study is to characterize the pharmacokinetic profile of SRT2104 after a~     single dose and multiple administrations in both type 2 diabetes mellitus patients and~     otherwise healthy cigarette smokers in a fed state, and to explore the effects of SRT2104 on~     potential biomarkers of activity for glucose control (HbA1c, glycated albumin and~     fructosamine) and/or Sirt1 activation.~   "
193477|NCT01031095|"~     The hypothesis:~      Low dose intracoronary unfractionated heparin is as effective and safe as standard dose~     intravenous unfractionated heparin on patients with elective percutaneous coronary~     intervention.~   "
193478|NCT01031082|"~     The purpose of this study is to identify and characterize the bacteria causing acute otitis~     media episode in HIV-positive and HIV-negative children (>=3 months to <5 years) in South~     Africa. Middle ear fluid sampling either by tympanocentesis or by careful sampling of~     spontaneous otorrhoea will be done; nasopharyngeal aspirate and urine sample will also be~     collected from the subjects.~   "
193479|NCT01031069|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety~     and immunogenicity of Cervarix™ in HIV infected females aged 15 to 25 years as compared to~     Merck's HPV vaccine (Gardasil®). For comparative purposes, a group of HIV negative females~     will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix™ or~     Gardasil®) according to a three-dose schedule (Day 0, Week 6, Month 6).~   "
193480|NCT01031056|"~     We have an active research program in gastrointestinal cancers including clinical trials,~     epidemiologic, and translational studies. We would like to establish a biospecimen bank~     linked to useful clinical information in order to learn more about diagnostic, predictive and~     prognostic markers for gastrointestinal cancers.~      PRIMARY OBJECTIVES:~      1. To collect and store tumor and normal tissue (previously collected paraffin embedded or~     frozen specimen) and blood in patients with gastrointestinal (GI) cancers.~      SECONDARY OBJECTIVES:~        1. Collect detailed clinical information via a patient questionnaire that includes~          demographic, socioeconomic, lifestyle, family, past medical, medication and cancer~          histories~        2. Collect details about the tumor specimen extracted from patient charts.~   "
193532|NCT01030367|"~     Organic nitrates increase levels of circulating endothelial progenitor cells (Thum et al.,~     Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54). Here, we want to test the effects of~     two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor~     cells and endothelial function.~   "
193481|NCT01031043|"~     The purpose of this research project is to determine the effect of a drug called bethanechol~     on swallowing function in patients with Ineffective Esophageal Motility (IEM). This drug is~     FDA approved for use in treating other conditions, but not for the treatment of IEM. There is~     currently no approved therapy for the treatment of IEM. This information is important for the~     possible development of new ways of treating patients with IEM and for the effectiveness of~     topically applied Bethanechol on patients with IEM.~   "
193482|NCT01031030|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, fluorouracil,~     and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. It is not yet known whether~     giving cyclophosphamide together with methotrexate and fluorouracil before, after, or without~     epirubicin hydrochloride is more effective in treating patients with breast cancer that can~     be removed by surgery.~      PURPOSE: This randomized phase III trial is comparing three regimens of cyclophosphamide~     given together with methotrexate and fluorouracil, with or without epirubicin hydrochloride,~     to see how well it works in treating women who have undergone surgery for breast cancer.~     (Group III was closed to new patients as of 12/7/2009.)~   "
193483|NCT01031017|"~     Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic~     administration of progesterone in singleton pregnancies at risk of preterm delivery has been~     shown to be effective in reducing the rate of such complication. The aim of this study is to~     investigate the effect of prophylactic administration of natural progesterone in twin~     pregnancies on the rate of preterm births.~   "
193484|NCT01031004|"~     This study is intended to show that the investigational contact lens is clinically equivalent~     to a currently approved contact lens, when worn as single-use on a daily basis.~   "
193485|NCT01030991|"~     The purpose of this study is to create a classification system for the heterogenous disorder~     of heart failure with preserved ejection fraction (HFpEF).~   "
193486|NCT01030978|"~     The purpose of this study is to determine if the Bright Bodies (BB) Healthy Lifestyle Program~     can help reverse early abnormalities in glucose metabolism and prevent the progression to~     type 2 diabetes (T2DM) in high-risk, obese youth with newly-diagnosed impaired glucose~     tolerance (IGT).~   "
193487|NCT01030965|"~     The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with~     placebo in subjects with COPD~   "
193488|NCT01030952|"~     A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to~     compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese~     drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different~     groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or~     Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.~   "
193489|NCT01030939|"~     The purpose of this study is to determine whether SB-649868 is safe, tolerable after repeated~     administrations in adult and elderly healthy volunteers. Pharmacokinetics and effects on~     cardiac function of repeated doses are studied~   "
193490|NCT01030926|"~     This trial was conducted in Europe. The aim of this clinical trial was to look into the~     concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of~     NN1250 in children, adolescents and adults with type 1 diabetes.~   "
193491|NCT01030913|"~     B type chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the western~     world. It is a disease that occurs primarily in aging individuals and occurs more frequently~     in males than females. Although B-CLL was considered a homogeneous condition, recent studies~     by our laboratory and others suggest that B-CLL cases can be divided into two subgroups.~      These sub-groups can be identified by either the presence or the absence of mutations in~     antibody genes and/or by the percentage of B-CLL cells expressing a particular protein called~     CD38. These two sub-groups (unmutated antibody genes high percent CD38 and mutated antibody~     genes low percentage CD38) follow strikingly clinically different courses. For example, the~     unmutated/CD38+ group experiences a much more aggressive disease and these patients almost~     invariably die much sooner than the cases in the other group. In addition, the patients in~     the mutated CD38+ group require much more chemotherapy than mutatedlCD38-. Finally,~     surprisingly there is a much higher representation of males in the poor outcome unmutated~     CD38 group than in the better outcome group. The reasons for these differences in clinical~     outcome and gender bias are unknown.~   "
193492|NCT01030900|"~     Background:~        -  Studies conducted at the National Cancer Institute suggest that certain chemotherapy~          drugs may be more effective if given by continuous infusion into the vein rather than by~          the standard method of rapid intravenous injection. One combination of six chemotherapy~          drugs, known as EPOCH-R, has had a high degree of effectiveness in people with certain~          kinds of cancer.~        -  Recent evidence also indicates that the effects of chemotherapy may be improved by~          combining the treatment with monoclonal antibodies, which are purified proteins that are~          specially made to attach to foreign substances such as cancer cells. A monoclonal~          antibody called campath (alemtuzumab) has been manufactured to attach to a protein~          called CD52 that may target tumor cells or the surrounding inflammatory cells.~        -  Researchers are interested in developing new treatments for large B-cell lymphoma or~          Hodgkin lymphoma that can best be treated with chemotherapy. This protocol is~          specifically for people with diffuse large B-cell or Hodgkin lymphomas that have not~          responded to standard treatments.~      Objectives:~      - To test whether giving campath (alemtuzumab) in combination with continuous infusion~     EPOCH-R chemotherapy will improve the outcome of lymphoma treatment.~      Eligibility:~      - Individuals 18 years of age and older who have large B-cell lymphoma or Hodgkin lymphoma~     that has not responded well to standard treatments.~      Design:~        -  During the study, patients will receive standard EPOCH-R chemotherapy, which includes~          the following drugs: etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin,~          and rituximab. The additional drug, campath, will be given by IV infusion on the first~          day of treatment over several hours.~        -  When the campath IV infusion and rituximab IV infusion are complete, the drugs~          doxorubicin, etoposide, and vincristine will each be given by continuous IV infusion~          over the next 4 days (that is, continuously for a total of 96 hours). Cyclophosphamide~          will be given by IV infusion over several hours on Day 5. Prednisone will be given by~          mouth twice each day for 5 days.~        -  Patients may be given other drugs to treat the side effects of chemotherapy, to prevent~          possible infections, and to improve white blood cell counts.~        -  The campath-EPOCH-R therapy will be repeated every 21 days, as a cycle of therapy, for a~          total of 6 cycles. Following the fourth and sixth treatment cycles (approximately weeks~          12 and 18) of campath-EPOCH-R treatment, study researchers will perform blood tests and~          CT/MRI scans on all patients to assess their response to the treatment.~   "
193502|NCT01030770|"~     This study will enrol patients with diabetes who have already elected to undergo pars plana~     vitrectomy (eye surgery) to remove persistent vitreous haemorrhage (a complication of severe~     diabetic eye disease in which blood fills the inner cavity of the eye, obscuring the vision~     and preventing treatment to stop the bleeding). Those in the treatment arm will have an~     intravitreal injection of ranibizumab (Lucentis) at the same dose used for the treatment of~     neovascular (wet) age-related macular degeneration (a disease that has some features in~     common with diabetic eye disease).~      It is hypothesised that this will promote clearance of the vitreous haemorrhage and that~     this, in turn, may mean that some patients do not need to proceed to vitrectomy.~   "
193493|NCT01030887|"~     Many cancer survivors suffer symptoms such as fatigue and dyspnea which may persist for years~     or months after their chemotherapy has finished. Despite the known benefits of exercise and~     its potential to address many of the symptoms after cancer, the type of practical exercise~     programme which best suits this population is not known.~      Many exercise programmes performed in cancer survivors take place over many weeks or months~     and include people with specific types of cancer. Such programmes may therefore not be~     suitable for the majority of cancer survivors and would pose serious practical difficulties~     with high drop-out rates and expensive resource consumption if they were extended into~     clinical practice.~      We propose to run an 8-week exercise intervention in a mixed cancer population.~      Hypothesis: A brief, individually tailored 8-week intervention will increase fitness and~     improve other physical symptoms in a mixed cancer survivor population after chemotherapy.~   "
193494|NCT01030874|"~     For patients recovering from acute illness, the ability to stand, walk, climb stairs, and~     participate in therapy are critical to their recovery and eventual discharge to the least~     restrictive environment. Orthostatic hypotension is a common finding in medically ill adult~     and elderly patients and is a potentially reversible contributor to functional impairment.~     This 4-year project will be a randomized controlled trial of a~     multidisciplinary-multicomponent intervention to determine whether routine identification and~     treatment of OH improves functional outcomes such as: balance, fall rates, therapy~     participation, length of stay, transfer to acute care hospital, and discharge location.~     Routine screening and management of OH may improve outcomes for rehabilitation and long term~     care patients, as well other high-risk patient populations.~   "
193495|NCT01030861|"~     The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to~     prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very~     high risk for developing the disease. Teplizumab has been studied in new onset type 1~     diabetes for testing of efficacy and safety in previous studies; other studies are currently~     in progress. The results of previous studies indicate that teplizumab reduces the loss of~     insulin production during the first year after diagnosis in individuals with type 1 diabetes.~     The purpose of this study is to determine if teplizumab can interdict the immune process that~     causes the destruction of insulin secreting beta cells in the pancreas during the~     pre-diabetic state and thereby prevent or delay the onset of type 1 diabetes.~   "
193496|NCT01030848|"~     The objective of this prospective study is to determine (1) the time course of~     patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome~     Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following~     TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and~     daily function during the study period, are of particular interest.~   "
193497|NCT01030835|"~     Background:~      - The National Institute of Drug Abuse (NIDA) is interested in developing a pool of potential~     research participants who may be eligible for research studies on drug abuse and addiction,~     pharmacological and psychosocial therapies for substance addiction, drug abuse and~     co-occurring psychiatric disorders, and the long-term effects of drugs on the development,~     function, and structure of the brain and other organ systems. To develop this pool of~     potential participants, researchers intend to screen individuals who may be eligible for~     future research studies.~      Objectives:~      - To identify, recruit, and screen participants for NIDA collaborative research protocols.~      Eligibility:~      - Individuals 18 years of age and older who are able to provide informed consent.~      Design:~        -  Eligible participants will undergo two screening interviews: a telephone interview and~          an in-person interview. The phone interview will determine eligibility for the in-person~          interview.~        -  The in-person interview, which may require up to five visits to the clinical center,~          will involve any or all of the following procedures: (1) full physical examination and~          medical history; (2) psychiatric interview; (3) psychological testing; (4)~          electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally~          invasive procedures as directed by the research staff.~        -  Participants will provide a photograph for confirmation of identity for subsequent~          visits and protocols.~        -  No clinical care will be provided under this protocol.~   "
193498|NCT01030822|"~     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a~     booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18~     months of age in children primed in primary study NCT00814710.~      This study also aims to assess the persistence of antibodies induced following primary~     vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to~     booster vaccination and following vaccination in the present study at approximately 24 months~     of age.~      The study is also designed to evaluate the immunogenicity, safety and reactogenicity of~     pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the~     second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.~   "
193499|NCT01030809|"~     Assess if the implementation of a treatment algorithm will improve the management of Crohn's~     disease (CD) in comparison to usual care based gastroenterology practices.~   "
193500|NCT01030796|"~     This project is a pilot study of caffeine abstinence in coffee-drinkers who have type 2~     diabetes. Evidence suggests that caffeine may impair the control of glucose levels,~     especially in those people who have type 2 diabetes. Eliminating caffeinated beverages from~     the diet might improve glucose control, but the difficulty of quitting is unknown. This pilot~     study will follow a small number of type 2 diabetic patients for three months after a brief~     intervention designed to help people quit caffeine. Data on success with maintaining~     abstinence and on changes in glucose control will be collected.~   "
193501|NCT01030783|"~     This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm~     trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed~     to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health~     outcome measurements of tivozanib and sorafenib.~   "
193503|NCT01030757|"~     The purpose of this study is to determine the response of liver tumors to radiation therapy~     using Tomotherapy.~   "
193573|NCT01029821|"~     1. The use of LMWH following open reduction and internal fixation of ankle fractures will~          reduce the number of thrombi formed.~        2. The rates of clinically significant DVT will be equivalent between two groups.~   "
193574|NCT01029808|"~     To collect and analyze data on female carriers of severe and moderate hemophilia A and B.~   "
193505|NCT01030731|"~     The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in~     the body, how they are distributed within the body and how they are removed from the body~     over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly~     into the vein) for 2 hours, before and after dialysis to patients with end-stage renal~     disease (ESRD) requiring hemodialysis or healthy volunteers.~   "
193506|NCT01030718|"~     To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or~     intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+)~     acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will~     continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)~   "
193507|NCT01030705|"~     This study will collect data on features for future pacemakers via an external~     non-implantable system.~   "
193508|NCT01030692|"~     The purpose of this study is to determine the safety and effects of rivastigmine and~     huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental~     administration of cocaine, on a number of physical and psychological measures.~   "
193509|NCT01030679|"~     The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501~     compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes~     for 8 weeks.~   "
193510|NCT01030666|"~     Study Hypothesis: The administration of 200 mg doxycycline once a day for 7 days after~     regenerative periodontal therapy of infrabony defects improves the results of therapy~     (clinical vertical attachment gains [CAL-V], bony fill) and reduces postoperative flap~     dehiscence and defect exposure.~      In each of 90 patients one infrabony defect shall be treated by regenerative techniques~     (guided tissue regeneration [GTR], enamel matrix derivative [EMD]). Prior to , 6, 12, and 24~     months after surgery clinical measurements (Plaque Index [PlI], probing depth [PD], vertical~     clinical attachment level [CAL-V], Gingival Index [GI]) and standardized radiographs are~     obtained.~   "
193511|NCT01030653|"~     Obese subjects may require a higher fixed oral maintenance dosing regimen of voriconazole~     compared to normal weight subjects to achieve comparable plasma exposures. The current study~     is designed to address this issue.~   "
193512|NCT01030640|"~     Subcutaneous administration of tanezumab can result in changes in the number of nerves around~     the injection site in the thigh.~   "
193513|NCT01030627|"~     This pilot study will document the efficacy and acceptability of administration of magnesium~     sulfate with the Springfusor pump for patients and staff at two sites where treatment or~     preeclampsia with magnesium sulfate is limited or not available. Currently, both sites refer~     patients to tertiary care facilities for further treatment.~   "
193514|NCT01030614|"~     Dexamethasone has been reported to reduce postoperative nausea and vomiting (PONV) after~     laparoscopic cholecystectomy (LC). However, its effects on other surgical outcomes such as~     pain and fatigue have been unclear. We evaluated the efficacy of preoperative dexamethasone~     in ameliorating postoperative symptoms after LC.~      Methods: Prospective, double-blind, placebo-controlled study, 210 patients scheduled for~     elective LC were analyzed after randomization to intravenous dexamethasone (8 mg) or to a~     placebo. All patients underwent standardized procedures for general anesthesia and surgery.~     Episodes of PONV and pain and fatigue scores were recorded on a visual analogue scale.~     Analgesic and antiemetic requirements were also recorded.~   "
193515|NCT01030601|"~     Macular Edema (Swelling of a particular site of the retina) can become a significant problem~     for Diabetics undergoing Cataract surgery. And a significant number of people who undergo~     Cataract surgery each year are diabetics. And when you multiply these two factors together~     you are left with a significant number of people who do not gain as much vision as their~     peers. Diabetics who develop Macular Edema actually can loose some vision after surgery and~     when you follow them up, they don't gain as much vision. This Study aims to prevent such an~     event from happening and therefore allow Diabetics to gain as much vision as they can from~     cataract surgery. This study will use Dexamethasone injected intravitreally (into the gel of~     the eye) at the end of cataract extraction to control Macular edema brought about by surgery.~     The main outcome is the central retina thickness and retinal volume as measured by Optical~     Coherence Tomography. Secondary outcomes are BCVA and incidence of Laser Treatment.~      Other Drugs, life Bevacizumab and Pegaptanib, have been used for this purpose but they are~     expensive and have potential systemic side-effects due to anti-VEGF (vascular endothelial~     growth factor) actions. Dexamethasone has been used in the eye for decades and is~     short-lived, minimizing possible systemic effects. Moreover, this drug is at least 15x~     cheaper than the previously mentioned ones and therefore has tremendous benefit for~     developing countries. We seek an alternative drug that can reduce or prevent Macular edema at~     a less expensive and safer way.~   "
193516|NCT01030575|"~     This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in~     blood and urine levels of inositol in premature infants at high risk for retinopathy of~     prematurity (ROP) following repeated doses of inositol. Based on previous studies, the~     premise is that maintaining inositol concentrations similar to those occurring naturally in~     utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants. The~     objective is to evaluate pharmacokinetics, safety, and clinical outcomes of multiple doses of~     three different dose amounts of myo-inositol (provided by Abbott Laboratories) in very low~     birth weight premature infants. This study will enroll an estimated 96 infants at 17 NICHD~     Neonatal Research Network sites. Infants will be randomly assigned to receive either 10 mg/kg~     of 5% inositol, 40 mg/kg of 5% inositol, 80 mg/kg of 5% inositol, or 5% glucose given in the~     same volumes and timings as the inositol dosage to maintain masking. Enrollees will receive~     their assigned dose or placebo daily, starting within 72 hours of birth, and continuing until~     they reach 34 weeks post-menstrual age, 10 weeks chronologic age, or until the time of~     hospital discharge, whichever occurs first. The study drug will be administered first~     intravenously; as the infants progress to full feeding, the drug will be given enterally~     (orally or via feeding tube). Enrollees will be seen for a follow-up examination at 18-22~     months corrected age. This pilot study is in preparation for a future Phase III multi-center~     randomized controlled trial.~   "
193849|NCT01026194|"~     The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in~     combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12~     weeks administration and to evaluate the safety and efficacy of MP-513 in combination with~     thiazolidinedione with an extension treatment for up to 52 weeks.~   "
193517|NCT01030562|"~     The purpose of this study is to gain a better understanding of the body's response to a human~     papillomavirus (HPV) (sexually transmitted disease), vaccine and booster shot. The study will~     also determine factors related to adolescents not following vaccination schedules. The HPV~     vaccine requires 3 doses (shots). Girls sometimes receive the 3 shots at the recommended time~     and sometimes girls receive the shots at non-recommended times. This study will evaluate if~     getting the shots at non-recommended times affects the level of protection provided by the~     vaccine. Participants will include about 1400 girls 9-17 years old receiving a third dose of~     HPV vaccine from their primary care clinician. The parent/legal guardian of each subject may~     answer a questionnaire related to the vaccine schedule. Study procedures include: medical~     history, questionnaires and blood draws. Participants will be involved in the study for about~     6 months from time of enrollment.~   "
193518|NCT01030549|"~     This study was designed to investigate the physiological properties of adult heart using~     cardiovascular magnetic resonance imaging in normal volunteers in Latin America.~   "
193519|NCT01030536|"~     The primary objectives of this study are to determine the maximum tolerated dose (MTD) or~     optimal biologic dose (OBD) and safety profile of CAT-8015 in participants with relapsed or~     refractory advanced B-cell NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma~     [FL], mantle cell lymphoma [MCL]) or CLL.~   "
193520|NCT01030523|"~     The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to~     standard length implants (OsseoSpeed™) with bone substitution.~      The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is~     as safe and predictable as placing standard length implants in combination with bone~     augmentation.~   "
193521|NCT01030510|"~     The investigators therefore hypothesized that remifentanil could prolong the onset time of~     rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial~     pressure and heart rate) during the anesthetic induction sequence.~   "
193522|NCT01030497|"~     The goal of this clinical research study is to learn if using the PEMFlex Solo II, a~     high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected~     to have cancer will give researchers the same or better information about the disease~     compared to the images taken with a routine PET/CT.~      Researchers will compare the images taken using the PEMFlex Solo II to the images taken~     during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s),~     magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within~     the last 30 days or may have in the next 30 days.~   "
193523|NCT01030484|"~     The NAFLD Database 2 will recruit at least 1,500 new adult participants suspected or known to~     have NAFLD or nonalcoholic steatohepatitis (NASH)-related cirrhosis and will also invite~     adult participants from the prior NAFLD Database and related studies (PIVENS trial and TONIC~     trial) to enroll in the NAFLD Database 2. To elucidate, through the cooperative effort of a~     multidisciplinary and multicenter group of collaborators, the etiology, natural history,~     diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH~     and its complications.~   "
193524|NCT01030471|"~     There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address~     this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to~     reduce depressive symptoms, improve family functioning, and improve medication compliance.~     The intervention is delivered in two phases (1 - reduction of depressive symptoms and family~     conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater~     likelihood of success if individual and family functioning variables are addressed first. To~     test the effectiveness of this intervention in reducing depressive symptoms and improving~     adherence, we will conduct a randomized controlled trial comparing this new intervention to~     usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary~     caregivers. Given the absence of this type of intervention and the significance of the~     problem, this study is timely and important, as it has the potential to positively impact~     diabetes-specific health outcomes.~   "
193525|NCT01030458|"~     The purpose of this study is to compare the blood pressure lowering efficacy of a treatment~     regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II~     type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide~     diuretic combined with a beta-blocker.~   "
193526|NCT01030445|"~     To assess whether a non-invasive cardiac output monitor can follow heart function in children~     during treatments in the hospital. To establish a normal reference for children who are well~     and awake.~   "
193527|NCT01030432|"~     The purpose of this study is to identify one or more doses of BMS-650032 that, when used in~     combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient~     activity against hepatitis C virus (Genotypes 1 and 4).~   "
193528|NCT01030419|"~     The purpose of this study is to test the effectiveness of a DVD-delivered, home-based,~     six-month physical activity intervention for older adults.~      A comparative effectiveness study of the FlexToBa DVD exercise program will be conducted in~     2014.~   "
193529|NCT01030406|"~     The primary objective of this study is to compare the relative abuse potential of two~     different doses of orally administered Acurox Tablets to orally administered~     immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.~   "
193530|NCT01030393|"~     Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study~     is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI~     on the implantation and pregnancy rates. The rational is that intrauterine hCG injection will~     attract regulatory T cells and improve implantation.~   "
193531|NCT01030380|"~     The purpose of this study was to determine the efficacy of Slendertone® Face™, to tone the~     muscles of the face and reduce the signs of facial aging among the following characteristics:~     radiance, tone, lift, firmness and complexion, following a 12-week programme of facial muscle~     toning. Slendertone® Face is a neuromuscular electrical stimulation (NMES) device which~     features a headset unit designed for application to the face for facial toning. The purpose~     of the headset is to locate and support a pair of stimulation electrodes on each side of the~     face, over the facial nerve just anterior to the ear.~   "
194499|NCT01017614|"~     The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is~     non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to~     inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb).~   "
193533|NCT01030354|"~     This study will examine whether a higher protein meal replacement diet (consisting of 1 gram~     of protein per pound lean body mass) is more effective in causing weight loss compared to a~     standard meal replacement protein diet (consisting of ½ gram of protein per pound of lean~     body mass). The study will assign approximately 100 subjects (50 each) to the following arms~     1) higher meal replacement diet program 2) standard meal replacement diet program. All~     participants will meet with a registered dietitian to provide nutrition education and~     behavior modification, including general exercise recommendations. As part of your~     participation, you must be willing to undergo a measurement of body fat, and blood tests, and~     be willing to use Herbalife Meal replacements as part of your diet for the duration of the~     study (one year).~   "
193534|NCT01030341|"~     A pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of~     continuous glucose monitoring (CGMS) in conjunction with an insulin pump to improve glycemic~     control for treatment of type 1 and type 2 diabetic patients with gastroparesis~   "
193535|NCT01030328|"~     This study will examine how an approved drug (TriLipix), when used in combination with a~     statin (a drug that lowers blood cholesterol levels), affects the makeup of plaque. Patients~     will be randomly assigned to receive either the study treatment (TriLipix plus Atorvastatin)~     or the comparison treatment (a placebo). Comparison of the effect on the makeup of plaque~     will be done by using coronary artery computed tomography angiography (CTA), which all~     participants will have at enrollment and at the end of the study (18 months after~     enrollment).~   "
193536|NCT01030315|"~     Study design:~        -  Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose~          escalation study of intravenously administered HM10760A in healthy adult Caucasian and~          Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort,~          subjects will be randomized to receive a single dose of HM10760A or placebo.~      Primary Objective:~        -  To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy~          adult Caucasian and Japanese subjects.~   "
193537|NCT01030302|"~     The purpose of this study is to monitor such factors as a past history, a previous history of~     drug use, the degree of response to initial treatment, the frequency of previous therapies,~     age, Eastern Cooperative Oncology Group (ECOG) performance status, which is used by doctors~     and researchers to assess how a patient's disease is progressing, assess how the disease~     affects the daily living abilities of the patient, and determine appropriate treatment and~     prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for~     re-treatment and the pattern of treatment in patients with multiple myeloma who were~     re-treated with injectable bortezomib.~   "
193538|NCT01030289|"~     This study aims to evaluate the effectiveness of transcranial direct current stimulation~     (tDCS) in decreasing food cravings. Specifically, this study will determine whether healthy~     subjects will report decreased food craving following a single 20-minute session of tDCS~     (compared to sham tDCS) delivered during and immediately following the exposure to food~     stimuli.~   "
193539|NCT01030276|"~     The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is~     a placebo-controlled, double-blind randomized controlled trial (RCT).~   "
193540|NCT01030263|"~     We wish to determine whether biopsies obtained with the technique of fluorescence-aided~     confocal endomicroscopy will detect more patients with specialized columnar epithelium than~     random biopsies among patients with Barrett's esophagus who are being monitored with~     endoscopy.~   "
193541|NCT01030250|"~     The goal of this study is to increase our understanding of the adjuvant chemotherapy~     experience in older and younger adults by prospectively describing the longitudinal~     trajectory of functional status, comorbidity, and quality of life from before the initiation~     of chemotherapy to 6 months after the completion of treatment in older (65 and older) and~     younger (under 65) adults. In addition, we will determine the effect of pre-treatment~     physical functioning on physical recovery after the course of adjuvant chemotherapy. The~     secondary objective of this study is to explore if factors other than chronological age~     (functional status, co-morbid medical conditions, nutritional status, psychological state,~     cognitive function, and social support) predicts which patients are more likely to experience~     morbidity (defined as grade 3-5 toxicity, hospitalization, dose reduction or delay, or~     premature discontinuation of chemotherapy course) from adjuvant chemotherapy.~   "
193542|NCT01030237|"~     The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison~     to Soothe XP in a specified population of dry eye patients.~   "
193543|NCT01030224|"~     The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after~     single IV doses.~   "
193544|NCT01030211|"~     Retrospective data in children with dengue hemorrhagic fever (DHF) and dengue shock syndrome~     (DSS), and in adults with dengue fever (DF), suggested a lack of benefit from prophylactic~     platelet transfusion for severe thrombocytopenia in dengue patients without bleeding.~     However, in Taiwan and Singapore, platelet transfusion was given to 13-50% of hospitalised~     dengue patients. This is a prospective randomised study to examine the safety and efficacy of~     prophylactic platelet transfusion in adults with dengue and severe thrombocytopenia without~     bleeding.~      The hypotheses are:~        1. Prophylactic platelet transfusion is safe in hospitalised dengue patients with severe~          thrombocytopenia.~        2. Prophylactic platelet transfusion is effective in preventing bleeding in hospitalised~          dengue patients with severe thrombocytopenia.~   "
193545|NCT01030198|"~     The purpose of this study is to measure the effectiveness of the RevLite Laser in the~     treatment of both fresh surgical scars and mature/older scars.~   "
193546|NCT01030185|"~     To investigate the safety and performance of the Automated Fluid Shunt in patients with~     ascites and diuretic resistance.~      Study Size and Duration The primary study population will include 40 patients enrolled and~     implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.~   "
193547|NCT01030159|"~     The purpose of this study is to create a large Thailand database documenting the severity of~     anemia and its management in the cancer population.~   "
193587|NCT01029639|"~     Hypoglycemic unawareness is a major problem in the treatment of Diabetes Mellitus.~     Hypoglycemic unawareness is the inability to recognize or sense early symptoms of low blood~     sugar. This study was instituted to evaluate the effect of Pulsatile intravenous (IV) Insulin~     on improving or reinstating the diabetics ability to sense or feel the symptoms associated~     with low blood sugar.~   "
193548|NCT01030146|"~     You are being asked to volunteer for a research study. You are being asked to participate in~     this study because you have completed at least one month of drug treatment with a nasal~     steroid and allergy testing and still have symptoms. This research study is sponsored by~     NeilMed Pharmaceuticals, Inc. The purpose of this study is to compare quality of life~     outcomes in patients who continue medical treatment plus the use of the NeilMed Sinus Rinse~     low-pressure pump with saline. Your participation in this study may help to improve the~     management of patients with allergic rhinitis.~      Allergic rhinitis is a common health problem, affecting between 10% and 40% of the world's~     population. Presently, antihistamines and nasal steroids are the standard treatment for~     allergic rhinitis. To further clarify these findings, we propose a study comparing the~     differences in quality of life improvements, by using a series of questionnaires, between~     subjects electing continued medical management and those electing medical treatment plus~     nasal wash.~      The investigators in charge of the study are Dr. Rodney J. Schlosser and Dr. Shaun A. Nguyen.~     Approximately 40 patients will be enrolled in this study at the Medical University of South~     Carolina (MUSC Hospital). You will have the choice of choosing either to receive only medical~     treatment or to receive medical treatment with nasal wash.~   "
193549|NCT01030133|"~     Although transcranial magnetic stimulation (TMS) is now considered a minimal risk~     intervention, is approved for the treatment of depression, and is widely used around the~     world, little is known about mechanisms of action of prefrontal rTMS for depression or pain.~     There is some evidence that the prefrontal cortex is involved in perception of control and~     may moderate the effects of perceived controllability on emotional reactivity to painful~     stimuli. The present study aims to investigate the effects of prefrontal rTMS and perceived~     controllability on pain perception in healthy adults.~   "
193550|NCT01030120|"~     The purpose of this study is to evaluate the safety and efficacy of etanercept for patients~     with chronic idiopathic urticaria unresponsive to antihistamines.~   "
193551|NCT01030107|"~     The purpose of the proposed study is to determine whether the amount children sleep is~     associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty~     children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study.~     For 1 week each, children will be asked to sleep their typical amount, increase their sleep~     by 1-½ hours, and decrease their sleep by 1-½ hours. Half of the children will be asked to~     increase their sleep first and half to decrease their sleep first. During each week, the~     following will be gathered: sleep duration (measured by actigraphy, which is a small device~     that measures sleep), levels of hormones measured through blood draws, self-reported hunger~     and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are~     to eat (measured using a computer activity), and child height and weight. We believe that~     when children sleep less they will show changes in hormones associated with hunger and~     appetite, report being hungrier, be more motivated to eat, and eat more food.~   "
193552|NCT01030094|"~     The purpose of this study is to investigate the influence of topiramate monotherapy on the~     bone and mineral metabolism markers, and bone density (the amount of mineral per square~     centimeter of bone ) in female participants with epilepsy (seizure disorder), before~     menopause (time in life when a woman stops having a menstrual period), as compared with~     healthy participants and comparative group received either carbamazepine or valproic acid~     monotherapy for at least last one year.~   "
193553|NCT01030081|"~     1. Study name:Amlodipine Prevents Morning Blood Pressure Surge Study~        2. Study drugs:amlodipine (Norvasc®) and nifedipine GITS (Adalat®)~        3. Rationale: Several recent studies compared 24-h blood pressure lowering effect of these~          2 dihydropyridine drugs, amlodipine and nifedipine GITS, but produced inconsistent~          results. Therefore, a randomized controlled trial with a larger sample size is required~          to compare these 2 dihydropyridines in the blood pressure control over 24 hours in~          general and during early morning hours and at night in particular.~        4. Objective: The primary objective of this study is to test the hypothesis that amlodipine~          compared with nifedipine GITS has a stronger effect in preventing morning blood pressure~          surge (4 am to 8 am) in mild to moderate hypertensive patients.The secondary objective~          of the study is to compare the effects of amlodipine and nifedipine GITS in reducing~          nighttime blood pressure (10 pm to 4 am) in patients with a decreased nocturnal blood~          pressure fall.~        5. Study design: The present study is designed as a randomized, actively controlled,~          multi-centre parallel group trial (phase Ⅳ) with two equally sized treatment groups:~          amlodipine and nifedipine GITS.~        6. Study population: 500 hypertensive patients meet the inclusion/exclusion criteria.~        7. Randomization and treatment: After stratification for centre, 500 eligible patients will~          be randomized into 2 groups. 250 will receive amlodipine 5 mg per day, and 250 will~          receive nifedipine GITS 30 mg per day. At 4 weeks of follow-up, the drug dosage per day~          may increase to 10 mg of amlodipine and 60 mg of nifedipine GITS, if blood pressure~          measured in doctor's office cannot be controlled to a level below 140/90 mm Hg. If there~          were no compelling indication, no other antihypertensive drug is allowed during the~          2-month trial.~        8. Follow up: All patients should give written informed consent at entry into the present~          study. In addition to 24-h ambulatory blood pressure monitoring, patients should also~          undergo a questionnaire survey and clinical measurements including clinic blood~          pressure. Patients will be followed up at the end of 4 weeks and 8 weeks after~          randomization.~        9. Sample size estimation: The number of required subject for the whole trial is 500.~       10. Timeline: October 2009 to July 2013.~       11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin~          Hospital, Shanghai, China.~   "
193554|NCT01030068|"~     The purpose of this study is to test whether it is feasible to provide a smoking cessation~     program together with a yoga program to help women quit smoking. We anticipate that women~     will be enthusiastic about the program and that we will be able to recruit and treat women~     for smoking cessation within the designated time frame.~   "
193555|NCT01030055|"~     This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and~     the effect of food on the bioavailability of TKI258, in adult patients with advanced solid~     tumor~   "
193556|NCT01030042|"~     Primary Objectives:~      Aim of this study is to compare the efficacy and safety of two different sequences of~     chemotherapeutic agents in order to optimize the treatment of patients with metastatic~     colorectal cancer progressed to a first line chemotherapy with FOLFIRI and bevacizumab.~     Primary endpoint will be overall survival, defined as the time elapsed from the date of~     randomization to the date of patient death due to any cause, or the last date the patient was~     known to be alive.~      Secondary Objectives Progression free survival, Quality of life, Health resource utilisation~     and economic evaluation, Toxicity and incidence of adverse events~      The study regimen includes:~      Strategy A: FOLFOX-4 followed, after progression, by irinotecan/cetuximab Strategy B:~     irinotecan/cetuximab followed, after progression, by FOLFOX-4 Patients will be randomly~     assigned to one of the two treatment sequences (with 1:1 ratio) using a block design~     randomization procedure stratified according to center.~      The patient accrual period is planned for approximately 36 months. To assess OS, all pts will~     be followed for up to 18 months after the last patient is randomised. The maximum estimated~     study duration is approximately 54 months.All statistical analyses will be based on an~     intention-to-treat approach. CONSORT rules will be applied to describe study flow and~     protocol deviations.~   "
193557|NCT01030029|"~     The effect of acupuncture for postoperative pain control remains controversial. We therefore~     studied the effects of electrical auricular acupuncture (AA) on postoperative opioid~     consumption in a randomized, patient-blinded clinical trial.~      40 female patients undergoing laparoscopy were included. Anaesthetized patients were randomly~     assigned to receive AA (shen men, thalamus and one segmental organ-specific point) or~     electrodes and electrical stimulation for 72 hours. Postoperatively patients received 1 g~     paracetamol every 6 hours and additional piritramide on demand. A blinded observer obtained~     the doses of piritramide and the visual analogue pain scores (VAS) at 0, 2, 24, 48, and 72~     hours.~      It was the aim of our study to find out, whether auricular acupuncture reduces postoperative~     pain.~   "
193558|NCT01030016|"~     The study was designed to investigate if atenolol is able to blunt blood pressure increase~     during resistance exercise in hypertensive subjects.~   "
193559|NCT01030003|"~     The purpose of the study is to determine the prevalence of sleep-disordered breathing in~     pregnant women during the third trimester of pregnancy and to investigate whether this is~     associated with high blood pressure in the mother and/or growth retardation in the baby.~   "
193560|NCT01029990|"~     Women who don't participate in Swedish cytology screening program are a minority of about~     10%, but constitute the majority of those who acquire cervical cancer. Over 50 000 women in~     the Västra Götalandregion have abstained from participation in the program for at least 2~     screening rounds (6 - 10 years, depending om age). We plan to test two promising strategies~     to increase participation. In a study of two different health policies women who have~     defaulted are randomised to receiving a telephone call from a midwife, receive an offer of a~     self-test for HPV or being included in a control group. This is an effectiveness study that~     should give an answer how participation could be increased and give the basis for a~     calculation of the costs involved, before decisions can be made about implementing either~     intervention.~   "
193561|NCT01029977|"~     The purpose of this study is to evaluate the effect of everyday practice modalities~     (mammography, US) on the MIRA technology.~   "
193562|NCT01029964|"~     The prevalence of overweight and obesity among children and adolescents has reached epidemic~     proportions worldwide. Among Swedish 10-year old children 15-20% are overweight and 3-5% are~     obese. The probability that an obese child becomes an obese adult is very high. This chronic~     disease requires lifetime treatment. The standard treatment of childhood obesity involves~     behavioural interventions focused on eating habits and physical activity. Studies often~     include small study samples, the absence of control groups and short treatments times.~     Several long-term follow-up studies of shorter interventions are available. The results from~     these studies are disappointing since the number of children who are cured i.e., have~     become non-obese is low. Thus, effective treatments are currently lacking.The National~     Childhood Obesity Center treats children in a University hospital setting. The children are~     enrolled from the catchment areas of the hospital as well as the rest of Sweden. Treatment~     alternatives include behavioural treatment (individual and group), low and very low calorie~     diet, pharmacological and surgical treatment. Patients treated with surgical and~     pharmacological methods safety is ensured using these treatments exclusively in controlled~     studies. The clinic was the first in Sweden with this wide range of treatment options.~      BORIS is a national health care quality register for childhood obesity, supervised by the~     Swedish Association of Local Authority and Regions.~   "
193563|NCT01029951|"~     The primary purpose of this study was to compare the relative effectiveness of cervical~     manipulation, mobilisation and the Activator instrument in the treatment of subacute~     non-specific neck pain. The secondary purpose was to describe any adverse effects of these~     treatments.~   "
193564|NCT01029938|"~     Intracranial aneurysm treatment with coil embolization is associated with relatively low~     complete occlusion and high recanalization rates. The investigators evaluate whether Willis~     covered stent implantation yields angiographic and clinical results superior to those with~     coil embolization.~   "
193565|NCT01029925|"~     The purpose of this study is to determine the response rate by RECIST criteria of oral~     dichloroacetate in patients with recurrent and/or metastatic and pretreated breast and~     non-small cell lung cancer.~   "
193566|NCT01029912|"~     Ankle dorsiflexor weakness (paresis) is one of the most frequently persisting consequences of~     stroke. The purpose of this exploratory study is to compare two different treatments --~     Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) and Cyclic~     Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of ankle movement and~     better walking after stroke.~   "
193567|NCT01029899|"~     The study is to evaluate how doctors in training are different from very experienced doctors~     when using force to perform colonoscopy with a device that monitors the amount of force~     applied to the colonoscope during colonoscopy.~   "
193568|NCT01029886|"~     No head to head comparisons between exenatide once weekly and liraglutide have been~     performed. Therefore, the purpose of this study is to compare exenatide once weekly to~     once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and~     other clinical benefits. The study includes a 26-week treatment period and a safety follow-up~     visit 10 weeks after the final study drug dose.~   "
193569|NCT01029873|"~     This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation~     study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the~     safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic~     profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have~     metastatic melanoma that is considered surgically incurable. The anti-tumor responses of~     ALT-801 with cisplatin will also be assessed in this trial.~   "
193570|NCT01029860|"~     The purpose of this study is to assess the effect of hospital admission on 24-hour ambulatory~     blood pressure (ABP) in hypertensive subjects.Treated or untreated hypertensive adults with~     open angle glaucoma underwent in-hospital and outpatient 24-hour ABP monitoring, in random~     order 4 weeks apart.~   "
193571|NCT01029847|"~     Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone~     metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare~     ultrasound examination with wholebody MRI etc.~   "
193572|NCT01029834|"~     The goal of this study is to test, in the primary care setting, the efficacy of an innovative~     intervention program for children aged 2-5 years with a BMI over the 85th percentile and one~     overweight parent (BMI >27 kg/m2.~   "
193575|NCT01029795|"~     The purpose of this study is to help answer the following research question(s):~        -  To test if taking LY2599506 for 12 weeks controls blood sugar better than taking~          glyburide for 12 weeks.~        -  To evaluate the safety of LY2599506 in participants with diabetes.~        -  To determine if LY2599506 has the ability to control blood sugar in participants with~          diabetes.~        -  To determine how much LY2599506 should be given to participants.~        -  To determine if LY2599506 has an effect on a participant's weight.~      The study design consists of 4 study periods: a screening period, a 4-week dose adjustment~     period, an 8-week treatment period, and a 4-week follow up period.~   "
193576|NCT01029782|"~     The purpose of this study is to determine whether oral cephalexin is equivalent to~     intravenous cefazolin plus oral probenecid for the treatment of uncomplicated skin and soft~     tissue infections in patients that present to the emergency department.~   "
193577|NCT01029769|"~     The main aim of the trial is to study whether a change of medication in non-responders to a~     two-weeks antipsychotic drug trial is more effective than continued treatment with the same~     antipsychotic. Hypothesis: Non-responders who are switched at 2 weeks to another~     antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who~     stay on the same antipsychotic~   "
193578|NCT01029756|"~     A randomised controlled trial of intubation by inexperienced anaesthetists, comparing the The~     Pentax Airway Scope AWS-S100 Rigid Video Laryngoscope(Pentax AWS) and the Macintosh~     Laryngoscope.~   "
193579|NCT01029743|"~     This study is to identify the following problems and questions with respect to the safety and~     effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of~     venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip~     replacement (THR) or total knee replacement (TKR) in the real-life conditions in its~     registered indication(s) as required by Korean Food and Drug Administration (KFDA).~        1. Known and unknown adverse reactions, especially serious adverse reactions~        2. Incidence of adverse reactions under the routine drug use~        3. Factors that may affect the safety of the drug~        4. Factors that may affect the effectiveness of the drug~        5. Other safety information related to overuse, drug interaction and laboratory~          abnormalities~        6. Other adverse reactions~   "
193580|NCT01029730|"~     The goal of this multi-center Phase II study is to add bortezomib to the highly active~     regimen of bendamustine and rituximab. In this study, bortezomib will be administered on a~     weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week~     cycles. This combination uses the standard bendamustine dosing schedule, and is more~     convenient than the 5-week regimen of these 3 drugs currently being studied.~   "
193581|NCT01029717|"~     Most children admitted to paediatric intensive care units (PICU) need to have medicines given~     to them into their veins using a narrow tube, so they do not need repeated injections. This~     tube is called a central venous catheter. Occasionally these catheters can cause infections~     in the blood and sometimes the tubes can get blocked by small blood clots.~      Some intensive care units already use antibiotic or heparin coated catheters, but there is no~     proof that these are better than the standard ones at preventing infections. Most of the~     PICU's in this country use standard lines. The only way to find out for certain is to compare~     children who are given antibiotic or heparin coated catheters with those who are given~     standard ones in a clinical trial. Because we do not know which type of catheter is best, the~     type of catheter each child receives in the study will be decided randomly by chance.~      Each child in the trial will have the same chance of getting any of these three catheters:~        -  Standard central venous catheter (not coated).~        -  Heparin coated central venous catheter. Heparin is a medicine that can stop blood from~          clotting and might stop the tubes being blocked and infections in the blood.~        -  Antibiotic coated central venous catheter. Antibiotics can be used to kill bacteria~          which cause the infections.~      The aim of this study is to see how the three types of catheters compare in reducing the~     amount of blood infections in children. We will also look at the costs involved. We hope to~     recruit 1200 children in the UK over 2 years. We hope that the information we get from this~     study will guide policy about purchasing impregnated Central Venous Catheters across the NHS~     and thereby improve treatment for children in the future.~   "
193582|NCT01029704|"~     The purpose of this study is to assess the effect of EGT0001442 on fasting plasma glucose~     after 28 days of treatment in subjects with type 2 diabetes.~      The study will also assess the pharmacokinetics (how much of the drug gets into the blood and~     how long it takes the body to get rid of it), safety and tolerability of EGT0001442, the~     effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose~     produced in the body by the urine.~   "
193583|NCT01029691|"~     The purpose of this study is to identify whether sleep-disordered breathing - as measured by~     overnight polysomnography - is associated with pre-eclampsia and to determine whether use of~     positive airway pressure can improve nocturnal blood pressure.~   "
193584|NCT01029678|"~     The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC)~     treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant~     radiotherapy in elderly patients.~   "
193585|NCT01029665|"~     The primary objective of this study is to determine the medical and neurodevelopmental~     outcomes of congenital diaphragmatic hernia (CDH) survivors at school-age (4-6 years)~     follow-up. It is generally assumed that older CDH survivors have normal daily function and~     are able to live normal lives, but this has not been adequately studied.~   "
193586|NCT01029652|"~     The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute~     gout flares relieves the signs and symptoms and prevents recurrence of gout flares in~     patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs)~     and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of~     canakinumab was compared to the corticosteroid triamcinolone acetonide.~      The purpose of the first 12-week extension study was to collect additional safety,~     tolerability and efficacy data in patients who have completed the core study CACZ885H2356.~      The purpose of the second 48 week open-label extension study was to collect additional~     long-term safety and tolerability data in patients who have completed the first extension~     study CACZ885H2356E1.~   "
193655|NCT01028729|"~     This single arm study will assess the safety and efficacy of Endostar combined with~     chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance~     therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).~   "
193588|NCT01029626|"~     The purpose of this study is to validate the Glasgow-Blatchford score for the stratification~     of patients with upper gastro-intestinal hemorrhage. This score is easy to calculate. It is~     mainly based on the hemoglobin, blood pressure and blood urea. if the score is zero, the~     bleeding is very low risk and the gastrointestinal endoscopy may be delayed and performed as~     an outpatient.~   "
193589|NCT01029613|"~     Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and~     course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of~     the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with~     wholebody MRI etc.~   "
193590|NCT01029600|"~     The purpose of the study is to compare two different treatment regimens for primary frozen~     shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.~   "
193591|NCT01029587|"~     Catastrophic Antiphospholipid Antibody Syndrome (CAPS) is a rare condition in which~     life-threatening blood clots form in multiple organs simultaneously and can lead to~     multi-organ system failure and death. The causes of CAPS are not entirely understood, but~     CAPS episodes are often triggered by stressful events such as infections, surgery, or trauma.~     For patients who survive an episode of CAPS, permanent kidney failure is not uncommon because~     the kidneys are the organ system most frequently affected in CAPS. Kidney transplantation is~     the treatment of choice for end-stage kidney disease, but patients with a history of CAPS are~     exceptionally high-risk kidney transplant recipients because the chance that surgery itself~     could trigger a life-threatening or transplant-threatening episode of CAPS is significant. As~     a result, patients with CAPS are not generally considered candidates for transplantation.~     Despite this, these patients have a severely decreased life-expectancy on dialysis and their~     long-term survival and quality of life would be greatly increased by a successful kidney~     transplant. In this trial, a drug called eculizumab will be tested for its ability to prevent~     CAPS after kidney transplantation in patients with a prior history of CAPS. Eculizumab is an~     inhibitor of the complement system, which is believed to be important in generating the~     inflammatory environment that leads to diffuse clotting of blood vessels in CAPS. The~     investigators hypothesize that by blocking the complement cascade using eculizumab, in~     conjunction with blocking the coagulation system, that kidney transplantation can be safely~     and successfully performed in patients with a history of CAPS.~   "
193592|NCT01029574|"~     Repair of the rotator cuff has high rates of re-rupture (20-54%), despite good clinical~     results. Several ways to improve the healing tendon-bone are currently studied, among them~     the most used is the use of growth factors. The platelet-rich plasma is a source of several~     growth factors, and is already used in various orthopedic procedures. The aim of this study~     is to evaluate the effectiveness of platelet-rich plasma in improve tendon-bone healing in~     arthroscopic rotator cuff repairs.~   "
193593|NCT01029561|"~     The aim of this project is to study the relationship between obstructive sleep apnea (OSA)~     and metabolic syndrome (MS) in a population of obese patients who are candidates for~     bariatric surgery. The investigators will study the influence of OSA through hypoxia and~     sleep fragmentation on different proinflammatory adipokines and cytokines, on metabolic~     syndrome and on insulin resistance, as well as how these respond to treatment with continuous~     positive airway pressure (CPAP).~      In the first part of the study (part A) the investigators will perform an observational study~     of cases and controls. Based on the diagnostic polysomnography the patients will be divided~     into two groups depending on their apnea-hypopnea index (AHI): OSA (AHI >= 15/h) and non-OSA~     (AHI <15/h). The results will be analyzed depending on the presence or not of OSA.~      In the second part of the study (part B), the patients with severe OSA (AHI ≥ 30/h) will be~     randomized into two groups: one group will receive CPAP + diet treatment and the other group~     will only receive diet treatment. After 3 months of treatment (CPAP + diet vs. diet), the~     investigators will analyze the overall effect on metabolic syndrome and the effect on its~     individual components, as well as the above-mentioned inflammatory pathways and insulin~     sensitivity, between the 2 groups. This will be carried out through a randomized controlled~     study in which the investigators will compare the effect of CPAP with the effect of~     conservative treatment.~   "
193594|NCT01029548|"~     The present study is designed as a prospective observational study directed at evaluating the~     frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune~     response in HIV-1 infected asymptomatic individuals, and to prospectively evaluate the~     immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative~     drug naїve subjects (secondary endpoint) in order to determine the impact of anti-Tat~     immunity on HIV disease progression as well as the potential use of anti-Tat immune response~     assessment for the clinical and therapeutic management of infected patients. This survey~     provided important information for the design, planning and conduction of future therapeutic~     vaccine trials based on the HIV-1 Tat protein in asymptomatic subjects.~   "
193595|NCT01029535|"~     This is a prospective, open-label experience study to be conducted at 6 clinical sites in~     Australia, with the objective to collect efficacy and safety information for Juvederm®~     VOLUMA™ when used for volumising the mid-face and cheek area.~   "
193596|NCT01029522|"~     A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy~     and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher~     risk cardiovascular disease in Korea.~   "
193597|NCT01029509|"~     The goal of this clinical research study is to find the highest tolerable dose of OPB-31121~     that can be given to patients with leukemia or myelodysplastic syndrome (MDS).~   "
193598|NCT01029496|"~     The best time of the umbilical cord clamping has not been fully understood. immediate cord~     clamping (with in 10 seconds after birth) has been standardized practice for many years,~     while WHO protocol recommends to wait for 60-90 seconds. but the umbilical cord may still~     pulse for more than 90 seconds. is it best to wait longer until the pulsing ceased? how the~     time of umbilical cord will affect the newborn? will the longer time be less umbilical~     bleeding and shorter departure time of the cord? the hypothesis of this study is: to cut the~     cord after the pulsing ceased is the best time for cord clamping and will result in better~     quality of life for the newborn and less cord bleeding and earlier departure time of the~     cord, that means less infections of the cord.~   "
194536|NCT01017133|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography, using the drug~     fluorine F18-EF5 to find oxygen and fludeoxyglucose F18 to find sugar in tumor cells may help~     in planning treatment for patients with non-small cell lung cancer.~   "
193599|NCT01029483|"~     Very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular~     weight-loss methods in the United States. The purpose of the Energy Balance Study is to~     explore how extreme differences in diet affect eating behaviors, activity and calorie-use,~     and body composition.~      We will conduct a controlled feeding study (all food will be provided for the duration of the~     study) in which obese adults will be randomly assigned to one of three dietary groups: a~     low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like~     diet, or a high-carbohydrate-calorie-restricted diet. The low-carbohydrate diet will be~     modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be~     based on the Dietary Approaches to Stop Hypertension (DASH) diet. During the first 3 weeks,~     participants will eat a typical diet adjusted so that they neither gain or lose weight. Then,~     for 6 weeks, they will eat their assigned research diet. Resting calorie use and body~     composition measurements will be taken at the end of week 2 and week 9. Frequent blood~     sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end~     of weeks 2 and week 9 and for 12 hours at the end of week 3.~      Change in body composition, activity and energy expenditure, and blood components known to~     influence eating behavior will be measured under typical diet conditions and after one-day~     and 6 weeks of the research diet.~   "
193600|NCT01029470|"~     Primary objective:~      To evaluate the efficacy in terms of oocyte retrieval number of rLH supplement in women with~     hyporesponse to rFSH after pituitary downregulation.~      Secondary objective:~      To further explore the efficacy of rLH supplement in women with hyporesponse to rFSH after~     pituitary downregulation To evaluate the safety of rLH supplementation in hyporesponse women~   "
193601|NCT01029444|"~     The purpose of this study is to determine if restoring normal metabolic function in patients~     with either type I or type II diabetes can improve the impact of the consequences of diabetic~     complications specifically on the wide swings in blood glucoses with erratic control even~     under optimal conditions. Patients are treated once a week with pulsatile intravenous insulin~     therapy mimicking normal insulin secretion. Blood sugar diaries and laboratory tests~     including quarterly Hemoglobin A1c levels are monitored to measure progress and outcomes.~   "
193602|NCT01029431|"~     The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically~     engineered for use both as a stand-alone laryngeal mask airway (LMA) and as a rescue device~     or Plan B device in the event of a difficult airway. As with some other types of LMA, it is~     then possible to insert an endotracheal tube (ETT) through the Air-Q® ILA, either blindly or~     mounted on a fibreoptic bronchoscope (FOB), to achieve endotracheal intubation. The objective~     of this study is to compare the Air-Q® ILA's performance to the current best option, the~     PLMA.~   "
193603|NCT01029418|"~     This will be a phase I/II clinical trial testing the combination of sorafenib and AZD6244 in~     advanced hepatocellular carcinoma with Childs A liver cirrhosis. The aim of the phase I~     portion is to determine appropriate dose of this drug combination. The phase 2 study will~     look at effectiveness and safety of this drug combination~   "
193604|NCT01029405|"~     The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment B, 2.0%~     and 0.5%, compared to Ointment Vehicle B, applied once or twice daily for 12 weeks, in the~     treatment of plaque type psoriasis~   "
193605|NCT01029392|"~     Our objective is to demonstrate that providing supplemental vitamin D to children with new~     onset DM will significantly decrease the levels of HbA1c and insulin requirement by the~     following methods.~        1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes~          mellitus (DM).~        2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level~          over the past few months) and document insulin requirements before and after vitamin~          supplementation is given.~      Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin~     requirements.~   "
193606|NCT01029379|"~     Propofol, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and~     maintenance of anesthesia.~      The aim of this study is to evaluate plasma concentrations of propofol in relation to depth~     of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic~     analyses of liver enzymes responsible for drug elimination.~      Our hypothesis is that there is an individual requirement of Propofol plasma concentration~     depending on genetic differences in drug elimination.~      200 patients, ASA classification 1, planned for elective surgery of a duration of at least 30~     minutes will be included in this study.~   "
193607|NCT01029366|"~     This is a Pilot/Phase I, single arm, single center, open label study to determine the safety,~     efficacy and cellular kinetics of CART19 (CTL019) in chemotherapy resistant or refractory~     CD19+ leukemia and lymphoma subjects. The study consists of three Phases:~      1) a Screening Phase, followed by 2) an Intervention/Treatment Phase consisting of apheresis,~     lymphodepleting chemotherapy (determined by the Investigator and based on subject's disease~     burden and histology, as well as on the prior chemotherapy history received), infusions of~     CTL019, tumor collection by bone marrow aspiration or lymph node biopsy (optional, depending~     on availability), and 3) a Follow-up Phase.~      The suitability of subjects' T cells for CTL019 manufacturing was determined at study entry.~      Subjects with adequate T cells were leukapheresed to obtain large numbers of peripheral blood~     mononuclear cells for CTL019 manufacturing. The T cells were purified from the peripheral~     blood mononuclear cells, transduced with TCR-ζ/4-1BB lentiviral vector, expanded in vitro and~     then frozen for future administration. The number of subjects who had inadequate T cell~     collections, expansion or manufacturing compared to the number of subjects who had T cells~     successfully manufactured is a primary measure of feasibility of this study.~      Unless contraindicated and medically not advisable based on previous chemotherapy, subjects~     were given conditioning chemotherapy prior to CTL019 infusion. The chemotherapy was completed~     1 to 4 days before the planned infusion of the first dose of CTL019.~      Up to 20 evaluable subjects with CD19+ leukemia or lymphoma were planned to be dosed with~     CTL019. A single dose of CTL019 (consisting of approximately 5x10^9 total cells, with a~     minimal acceptable dose for infusion of 1.5x10^7 CTL019 cells) was to be given to subjects as~     fractions (10%, 30% and 60% of the total dose) on Day 0, 1 and 2. A second 100% dose of~     CTL019 was initially permitted to be given on Day 11 to 14 to subjects, providing they had~     adequate tolerance to the first dose and sufficient CTL019 was manufactured.~   "
193608|NCT01029353|"~     This trial will compare the effectiveness of two surgical procedures -laparotomy versus~     drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal~     perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with~     NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to~     receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free~     survival at 18-22 months corrected age.~   "
193741|NCT01027598|"~     This randomized, placebo-controlled, Phase II trial will compare the combination of erlotinib~     with pazopanib (providing concurrent EGFR and VEGFR inhibition) with erlotinib alone in the~     second- or third-line treatment of patients with advanced NSCLC. This study will be conducted~     though the Sarah Cannon Research Consortium, a community-based clinical trial network.~   "
193609|NCT01029340|"~     The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of~     prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period~     (split into two six month treatment periods). The study will compare 2 different methods~     (assays) for measuring the amount of study drug, the chromogenic substrate assay per European~     Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ).~     During one six month period patients will receive the study drug where the dose has been~     measured using the (CS/EP) and during the other six months period the dose will be measured~     based on the Chromogenic Substrate Adjusted assay CS/ADJ)~   "
193610|NCT01029327|"~     Previous animal studies have shown that extracts of Curcumin lowers blood glucose.~   "
193611|NCT01029314|"~     Primary study objective is to test the accuracy of the Genius 2 tympanic thermometer and the~     Exergen TAT-5000(TM) temporal artery thermometer as compared with serial perioperative core~     temperature measurements obtained in cardiac surgical patients during cardiopulmonary bypass.~     Study hypothesis: The Genius 2 thermometer will display greater precision and accuracy than~     the Exergen TAT-5000 thermometer when compared to core body temperature in patients~     undergoing CABG surgery.~   "
193612|NCT01029301|"~     Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis~     and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin~     dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen~     modification, skin laxity and cellulite (dermis and hypodermis).~      EndyMed has developed the EndyMed Pro system - Computerized Radiofrequency System for Skin~     Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern~     can be produced allowing to selectively heating one or more of the target tissues (epidermis,~     dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be~     targeted, creating enough thermal effect to induce collagen remodeling with no ablative~     thermal damage in the epidermis or dermis. This post marketing study is intended for~     evaluation of safety and efficacy of the EndyMed Pro system.~   "
193613|NCT01029288|"~     The proposed trial seeks to determine the impact of patient decision aids versus usual care~     on measures of patient involvement in decision-making, diabetes care processes, medication~     adherence, glycemic and cardiovascular risk factor control, and resource utilization in~     nonurban practices in the Midwestern United States. Upon completion of this trial, the~     investigators will have new knowledge about both the effectiveness of diabetes decision aids~     in nonacademic nonurban practices and about the processes that promote or inhibit the~     successful implementation of patient decision aids in such practices.~   "
193614|NCT01029275|"~     The aim of the study is to evaluate the interest of a six month pre-operative treatment with~     a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a~     pituitary adenoma responsible for acromegaly.~   "
193615|NCT01029262|"~     The purpose of this study is to investigate whether lenalidomide would reduce the number of~     red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants~     with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study~     also investigated the safety of lenalidomide use in these participants. Two-thirds of the~     participants received oral lenalidomide and one-third of the participants received oral~     placebo.~   "
193616|NCT01029249|"~     Oral human papillomavirus (HPV) and oral warts are common health concerns for HIV-infected~     people. This study will examine the frequency of oral HPV DNA shedding and oral warts in~     HIV-infected people who are enrolled in ACTG A5257 and who are beginning treatment with~     highly active antiretroviral therapy (HAART).~   "
193617|NCT01029236|"~     The purpose of this study is to assess the effect of Metabolism-boosting Beverages (MBB)~     containing green tea extract with a standardized amount of epigallocatechin gallate (EGCG)~     and caffeine.~   "
193618|NCT01029223|"~     The purpose of this study is to determine the effect of slowing heart rate upon both central~     and peripheral blood pressures using a medication called Ivabradine which slows heart rate~     without affecting heart contraction, and to compare the effects of ivabradine to a~     traditional blood pressure lowering medication called metoprolol (which is a beta-blocker).~   "
193619|NCT01029210|"~     Increased life expectancy has attracted research attention, interested in provide a quality~     and healthy aging. According to the latest census conducted in 2010 by IBGE, Brazilian~     population consists of 97,342,162 women, whom estimates 30 million are between 40 and 65~     years old, a period that includes the climacteric. Therefore, clinical conditions such as~     osteoporosis becomes significant, either from public health policy standpoint or in relation~     to the social aspect, by compromising life quality. Women also suffer more from~     temporomandibular disorders (TMD) than men, and the beginning of this situation occurs after~     puberty, with peaks during the reproductive and remission periods after menopause. Female sex~     hormones involvement in osteoporosis is well established, but their participation in the TMD~     is still controversial. Thus, this study aims to investigate the role of systemic bone mass~     in menopausal women as a risk factor for articular TMD, as well as the TMD pain behavior~     during menopause transition periods (48 to 55 years), postmenopausal (56-65 years) and~     senescence (65-70 years). Therefore, 100 women attended by the HC - FMUSP Gynecology~     Division, Climacteric Sector, were clinically evaluated by the Research Diagnostic Criteria~     for Temporomandibular Disorders (RDC/TMD), used to obtain diagnoses and their associations,~     as well as to quantify the TMD pain sensitivity degree through the Craniomandibular Index~     (CMI), both applied by a single examiner. The bone densitometry provided bone mass data of~     femoral neck and lumbar spine (L1-L4). The RDC/TMD performance as a diagnostic test also was~     subjected to analysis, considering the 3.0 Tesla magnetic resonance imaging as reference~     standard, undergoing 30 women, of 100 assessed, in this imaging exam. After analyzing the~     results, it was shown that the risk posed by osteopenia was 1.33 (IC95% 1.20 - 1.46), with a~     risk increase of 0.33, while the risk of osteoporosis showed 1.39 (IC95% 1,20 - 1.23 to~     1.55), increased by 0.39. Joint diagnoses predominated (68.0%), while 18.0% muscular~     diagnoses and 14.0% corresponds to the absence of clinically diagnosable conditions,~     according to the RDC/TMD. The performance of the RDC/TMD to diagnose articular DTM revealed~     accuracy of 68.0%, sensitivity of 83.0%, specificity 53.0%, pre-test probability of 52.0%,~     positive predictive value of 60.0 % and negative 74.0%, positive likelihood ratio of 1.77 and~     negative 0.32. As for the soreness sensibility in TMD, it was found that aging shows a clear~     tendency towards its reduction (A =- 4.5, p = 0.0324). Then, the study concluded that the~     decrease in female sex hormones, peculiar to aging, increases the risk of articular TMD,~     although this pain disfunction decreases with age. The RDC/TMD can be used for large~     populations screening, but its indication in clinical practice should be done with caution.~   "
193620|NCT01029197|"~     Purpose: To conduct a pilot study of a cognitive-behavioral treatment (CBT) for PTSD and~     substance abuse among persons with serious mental illness (SMI) treated in a community~     setting.~      Participants: Participants will be 50 volunteer adult individuals with PTSD and substance use~     disorders (SUD), and SMI who are receiving services at the Freedom House Recovery Center,~     served through the Orange Person Chatham (OPC) Area Program.~      Procedures (methods): Participants will be randomly assigned to one of two conditions: 1) the~     CBT intervention plus treatment as usual; or, 2) treatment as usual.~   "
193621|NCT01029184|"~     In this study, non allergenic cereals will be tested in infants with atopic symptoms. The~     test will be performed in a hospital.~   "
193622|NCT01029171|"~     This study will be a randomized controlled trial to determine the efficacy of the Otago~     Exercise Program (OEP) on falls among seniors with a history of falls.~   "
193623|NCT01029158|"~     RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in~     pre-clinical studies in animals, has shown comparable scar improvement efficacy to the~     standard twice-dosed Juvista formulation. The aim of this trial is to investigate the~     efficacy of RN1006 compared to Juvista in a human volunteer model~   "
193624|NCT01029145|"~     The primary purpose of the study is to explore management of symptomatology in patients with~     bipolar disorder that experience a new manic,depressive or mixed episode and are treated with~     Seroquel XR monotherapy/adjuctive, in routine clinical practice in Romania~   "
193625|NCT01029132|"~     To investigate the characteristics of treatment responders to galantamine.~   "
193626|NCT01029119|"~     Blood pressure meter model CH-101 was to be assessed against the standard mercury~     sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.~   "
193667|NCT01028573|"~     The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon~     before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel~     preparation solution. Another purpose is to see if taking half of the bowel preparation~     solution on the evening before the colonoscopy and half on the morning of the colonoscopy~     will result in a cleaner colon than taking all of the bowel preparation solution on the~     evening before.~   "
193627|NCT01029106|"~     This is a prospective, non-randomized, observational, multicentre (5 sites) study in which~     subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR~     operative procedure.~      The study will collect preoperative urologic testing, medical history, and subject quality of~     life patient questionnaires, Intraoperative procedural data will be collected.~      Postoperative complications, urologic, testing, and subject questionnaires will be collected~     at intervals up to 24 months. The anatomic position of the device will be characterize by~     transvaginal ultrasound testing.~      To determine the rate and/or improvement rate of patients who have received the Gynecare~     Secur device after 12 months and after 24 months.~   "
193628|NCT01029093|"~     Investigation of changes in gray and white matter during immoblisation after injury of the~     right upper extremity via two MR Investigations of the brain at two different times.~   "
193629|NCT01029080|"~     The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients~     with sepsis with a sepsis-associated delirium.~   "
193630|NCT01029067|"~     Over a period of 4 weeks, metacognitive training for schizophrenia patients (MCT), delivered~     both in a group and individually, is compared to cognitive remediation (CogPack training).~     Blind to treatment assignment, both groups are assessed before intervention and four weeks~     later with the Positive and Negative Symptoms Scale (PANSS), the Psychosis Rating Scales~     (PSYRATS) and cognitive tests. Delusion severity serves as the primary endpoint. It is~     assumed that MCT will improve delusion severity to a greater extent than CR in the course of~     4 weeks taking medication into account.~   "
193631|NCT01029054|"~     This study is designed to evaluate the safety and to determine the maximum tolerated dose of~     carfilzomib + lenalidomide in combination with dexamethasone in newly diagnosed Multiple~     Myeloma patients who have not received treatment.~   "
193632|NCT01029041|"~     Fibromyalgia is a rheumatologic syndrome characterized by widespread chronic pain, tender~     points and other symptoms as fatigue, sleep disturbances, anxiety and depression. Therapeutic~     exercises are described as an important form to management of symptoms. This study aims to~     assess strengthening and stretching exercise efficacy in symptoms and quality of life of~     Fibromyalgia patients. The study is done at General Clinical Hospital of Medicine Scholl of~     University of Sao Paulo. 63 subjects undergo the study and they are divided into three~     groups: 1 strengthening exercise, 2 stretching exercise and 3 control group. Patients are~     evaluated by following instruments: Fibromyalgia Impact Questionnaire, Medical Outcomes Study~     36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire,~     dolorimetry at tender points by a Fischer dolorimeter, finger-to-tip floor test for muscular~     flexibility, dynamometer EMG System do Brasil for strength test of extension and flexion of~     knees and elbows, time to get up and go test, functional reach test, sit-to-stand test.~     Subjects of 1 strengthening exercise group undergo a global strengthening program and 2~     stretching exercise group undergo a global stretching program. All programs have 12 weeks of~     duration and physical therapy is twice a week. The control group does not do any intervention~     during 12 weeks and after the second evaluation they enter the common program of physical~     therapy. Data are being analyzed by descriptive and interferential statistics procedures.~   "
193633|NCT01029015|"~     This is an observational, physiology pilot study of subjects with overactive bladder,~     insomnia and normal subjects. No study drug will be given. All subjects will complete a one~     week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility~     requirements will complete a single sleep night stay in a sleep laboratory setting. During~     the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the~     morning following the sleep night stay, subjects will complete a sleep questionnaire and this~     will complete their participation in the study.~   "
193634|NCT01029002|"~     A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney~     Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney~     damage.~   "
193635|NCT01028989|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women of reproductive age, and is~     associated with infertility, risk for obesity and type 2 diabetes, and impaired quality of~     life. The elevated insulin characteristic of PCOS is likely to play a major role in its~     symptoms. Manipulation of dietary carbohydrate quantity and quality (glycemic load; GL) may~     lower insulin and improve both reproductive and metabolic outcomes. The purpose of this study~     is to determine if a lower GL diet intervention is more effective than a standard (STD) diet~     in improving reproductive and metabolic outcomes of women with PCOS in the absence of weight~     loss.~   "
193636|NCT01028976|"~     The purpose of this study is to determine whether or not Vitamin C (1000 mg/day) can reduce~     markers of inflammation, especially C-reactive protein (CRP), in obese persons with baseline~     CRP greater than 1 mg/dl.~   "
193637|NCT01028963|"~     The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B~     in subjects with Type 2 diabetes mellitus.~   "
193638|NCT01028950|"~     To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous~     thromboembolism (VTE) in patients with acute medical illness.~   "
193639|NCT01028937|"~     The purpose of this U.S. Clinical Trial on treatment of sighted eyes is to investigate the~     safety and effectiveness of optimal keratoplasty (Opti-K™) treatments for hyperopia~     correction using the NTK Enterprises (NTK) Opti-K System.~   "
193640|NCT01028924|"~     The primary objective of this trial is to investigate if teduglutide has an effect on cardiac~     repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible~     effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration),~     pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect~     of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a~     screening and a treatment phase of four treatment periods. There is a washout period of at~     least 7 days and 4 weeks at maximum between administrations. The expected total trial~     duration for the individual subject will be about 7 weeks (maximum 17) weeks.~   "
193641|NCT01028911|"~     This is a study to evaluate the safety, tolerability and blood levels of PF-03654746 in~     subjects will mild to moderate Alzheimer's disease.~   "
193642|NCT01028898|"~     In the investigators study, the investigators will focus on the screening of the related~     proteins and miRNA to IBS in order to reveal the possible clues or molecular mechanism for~     this disorder.~   "
193643|NCT01028885|"~     This is a prospective clinical trial examining the use of MRI to measure internal organ~     motion and any resulting changes in the target volume (shape and location) during a course of~     post-operative radiation therapy for prostate cancer. The goal is to better understand and~     characterize these physiologic variations so that they can be accounted for during the~     treatment planning process. The ultimate longer-term clinical goal here is to provide a form~     of adaptive radiation therapy in the future, such that if major changes are seen over an~     8-week course of radiation therapy in our study. This may argue for hypofractionating those~     patients who are most likely to have major shifts over time.~   "
193644|NCT01028872|"~     Aspheric intraocular lenses can effectively reduce higher-order aberrations and improve~     contrast sensitivity function after cataract surgery.~   "
193645|NCT01028859|"~     A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting~     toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection~     on a weekly schedule in patients with advanced solid cancers failed to standard therapy. The~     usefulness of the this regimen is evaluated by response rate, progression free survival and~     vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI).~   "
193646|NCT01028846|"~     Increased endogenous glucose production (EGP) is the major cause of postabsorptive~     hyperglycemia in type 2 diabetes mellitus (T2DM). While EGP is inhibited by both glucose and~     insulin in non-diabetic animals and humans, T2DM is associated with increased EGP despite~     elevated plasma glucose and insulin concentrations. In fact, we and others have reported~     direct inhibitory effects of hyperglycemia itself on EGP in nondiabetic subjects, independent~     of other hormonal or metabolic signals, which are markedly blunted in subjects with T2DM.~      The medial hypothalamus mediates hormonal signals which affect glucose metabolism.~     ATP-sensitive potassium (KATP) channels are expressed in the hypothalamus and can be~     activated by insulin. Activation of these channels appears to be an important common~     mechanism whereby both systemic glucose and insulin suppress EGP, and may account for almost~     50% of EGP suppression by both agents. Diazoxide has been shown to inhibit EGP in rodents via~     the activation of these KATP channels in the hypothalamus, while the KATP channel inhibitor~     glyburide blocks these effects. There is evidence to suggest that central activation of KATP~     channels is still able to suppress EGP in animal models that are otherwise resistant to the~     effects of systemic glucose and insulin.~   "
193647|NCT01028833|"~     The purpose this study is to determine the effects of power mobility on the development and~     function of young children of young children whose severe physical disabilities limit their~     exploratory behaviors and may unnecessarily restrict their cognitive, communication, and~     social-emotional development.~   "
193648|NCT01028820|"~     This is an 8 week research study of aripiprazole (abilify) which is used to reduce irritable~     behaviors in autism spectrum disorders. All participants will receive active study~     medication. Participants will also receive diagnostic and cognitive evaluations at no cost.~     Participants will be required to undergo two fMRI (functional magnetic resonance imaging~     scans) where we will take pictures of your brain while performing simple tasks.~   "
193649|NCT01028807|"~     Purpose:~      To determine the safety and efficacy of early enteral feeding after distal (ileum-colon)~     elective bowel anastomoses in children.~      Methods:~      Controlled randomized trial including all pediatric patients with distal elective bowel~     anastomosis, excluding non-elective and high risk patients. VARIABLES:~      Demographic characteristics, operative time, anastomosis placement,~      Follow up: Tolerability variables: beginning peristalsis, beginning bowel movement, time to~     full diet intake, post-operative stay. Safety variables: mild and persistent vomiting,~     persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or~     dehiscence, reoperation and death. At the end of surgery were randomized to:~        1. Experimental group(EG): Early feeding group, after a 24 hours fasting period, with good~          abdominal conditions (once the post operative ileus had solved), oral fluids and diet~          was started.~        2. Control group (CG): obligatory 5-day fasting. Once the regular diet was tolerated, the~          patients were discharged. Statistics: Descriptive statistics for global description.~          Student's t test for quantitative variables and Chi square test for qualitative~          variables, a p-value less than 0.05 was considered statistically significant.~   "
193650|NCT01028794|"~     The purpose of this study is to determine whether autologous bone marrow mononuclear cells~     transplantation after stroke is safe and/or effective to improve neurological outcome.~   "
193651|NCT01028781|"~     Patients will undergo a standard history and physical examination detailing objective~     clinical exam findings performed by one of the co-investigators. The research coordinator~     will obtain baseline values for intensity of pain, quality of life, and coping strategies.~     Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks~     Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on~     VAS from week 2.~   "
193652|NCT01028768|"~     To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide~     following subcutaneous (SC) administration of 10 mg teduglutide.~      Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A~     further objective is the description of the PK of teduglutide following SC administration of~     10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy~     subjects.~   "
193653|NCT01028755|"~     This is the first time this drug will be tested in humans in order to determine the safety of~     the drug, the ability to tolerate the drug, to measure how the drug is used in the body and~     as a result of these tests to determine a maximum dose to be given. Specifically, the~     following aspects will be investigated:~        -  side effects of BAY79-4620 given as infusion every three weeks~        -  evaluation of highest and safest dose of BAY79-4620~        -  distribution and concentration of BAY79-4620 in the blood at specific times after~          administration~        -  effect of BAY79-4620 on tumor growth~        -  assessment of biomarkers (eg, analysis of specific proteins in blood samples, or~          analysis of tumor tissue sampled at the time of cancer diagnosis) for changes during the~          treatment or prediction of safety or benefits of the treatment with BAY79-4620.~   "
193654|NCT01028742|"~     The purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and~     to identify predisposing factors in order to establish a rational responsible socioeconomic~     screening program.~   "
193742|NCT01027585|"~     To study the effect of cinnamon on postprandial blood glucose, and plasma concentrations of~     insulin in subjects with impaired glucose tolerance.~   "
193656|NCT01028716|"~     This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works~     in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus~     and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host~     disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of~     bone marrow from half-matched (haploidentical) donors. This approach has extended the~     transplant option to patients who do not have matched related or unrelated donors, especially~     for patients from ethnic minority groups. The graft contains cells of the donor's immune~     system which potentially can recognize and destroy the patient's cancer cells~     (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune~     system is prevented by giving low doses of chemotherapy (fludarabine phosphate and~     cyclophosphamide) and total-body irradiation before transplant. Patients can experience low~     blood cell counts after transplant. Using stem cells and immune cells collected from the~     donor's circulating blood may result in quicker recovery of blood counts and may be more~     effective in treating the patient's disease than using bone marrow.~   "
193657|NCT01028703|"~     Studies of patients with established kidney disease, even when this is mild, appear to show~     that they are at high risk of heart failure, stroke and sudden cardiac death. This may be~     because kidney disease causes stiffening of the arteries in the body which means that the~     heart and brain are damaged by high blood pressure. By studying patients before and after the~     removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for~     the first time in man the effect of an isolated reduction in kidney function on the structure~     and function of the arteries and heart.~      Hypotheses. An isolated reduction in GFR occuring after surgical uni-nephrectomy is~     associated with long term adverse cardiac and vascular effects which include:~        1. Increased arterial stiffness and left ventricular mass~        2. Abnormalities in left ventricular systolic and diastolic function~        3. Increased oxidative stress, inflammation and collagen turnover~   "
193658|NCT01028690|"~     Helicobacter pylori colonizes approximately to 50% of the world-wide population.~      There is an exigency to find routes alternating to control the infection with an ample~     perspective but without the complications of induction of resistance to antibiotics.~     Supplement dietetic with Lactobacillus reuteri (L. reuteri) in humans takes to the~     colonization of epithelium gastric and this, combined with the observation of which L.~     reuteri has the capacity to inhibit the growth of H. Pylori and its union to the gastric~     mucosa, indicates the potential that the native human bacteria control and influence in the~     colonization in humans.~      The acid-lactic bacteria (in particular the lactobacillus) have been studied by their effects~     in humans infected with H. Pylori with some success to reduce the load of bacteria Studies~     using supplements with L. reuteri as much in infected symptomatic patients as asymptomatic~     with H. pylori showed a clear reduction of the load of bacteria after 4 weeks of use and this~     was concordant with a reduction in the symptoms associated to the infection.~   "
193659|NCT01028677|"~     Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves~     social cognition, social functioning and decreases paranoia and other psychotic symptoms in~     schizophrenia.~      Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating~     for paranoia.~      Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal~     spray (6 insufflations/dose or 24 IU) for 6 weeks. Before, during and at the end of the~     trial, each subject will undergo social cognitive measures (primary outcomes) and psychiatric~     symptom ratings (secondary outcomes).~   "
193660|NCT01028664|"~     A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure~     (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to~     detect the induced IOP reduction.~   "
193661|NCT01028651|"~     This was a multicenter, prospective, observational, open-label study. Patients meeting~     inclusion/exclusion criteria received treatment with treprostinil as recommended by their~     treating physicians and were followed according to standard of care. This observational study~     collected clinical data and biologic specimens from patients who were treated for~     portopulmonary hypertension (PoPH), with a goal of achieving hemodynamic parameters~     appropriate for orthotopic liver transplantation candidacy, including mean pulmonary arterial~     pressure (mPAP) less than 35 mmHg and pulmonary vascular resistance (PVR) less than 3~     Wood-units (WU) at Week 24 in patients with severe PoPH.~   "
193662|NCT01028638|"~     Everolimus indirectly inhibits angiogenesis by reducing VEGF production. VEGF can be~     non-invasively visualized and quantified with serial 89Zr-bevacizumab PET imaging in~     patients.~      The investigators hypothesize that a decline in VEGF early during everolimus treatment in~     patients with metastatic renal cell carcinoma predicts treatment efficacy.~      89Zr-bevacizumab PET scans will be performed at baseline, after 2 and 6 weeks of everolimus~     treatment in 14 adult patients with metastatic renal cell carcinoma.~   "
193663|NCT01028625|"~     The purpose of the study is to test whether Cognitive Behavior Therapy (CBT) plus heart~     failure self-care education is superior to usual care for depression.~   "
193664|NCT01028612|"~     The main objective of this study is to assess the initial safety of the combination of~     interventional ablation and external beam radiotherapy including acute and late toxicity (90~     days) for patients with early stage lung cancer.~   "
193665|NCT01028599|"~     The purpose of this study is to investigate the effect of physical training on work capacity~     and vascular function after heart transplantation, cardiac transplant recipients are~     randomized to 8 weeks of intense physical training or control. Vascular function is measured~     non-invasively. Effect on the hormones and the immune system is evaluated using blood~     samples.~   "
193666|NCT01028586|"~     Parkinson's disease is a major neurodegenerative disorder in which there is a progressive~     loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of~     dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a~     precursor of DA that crosses the blood brain barrier, and also to the use of selective~     inhibitors of MAO B, the major DA metabolising enzyme in man.~      This is a double-blind, placebo-controlled, extension trial, parallel-group, randomised,~     multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100~     mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine~     agonist in subjects with early idiopathic Parkinson's Disease.~      The principal objective is to evaluate the time to first intervention, as some previous data~     suggested that safinamide may delay the need for further dopaminergic supplementation.~   "
193668|NCT01028560|"~     In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing~     asthma and allergy related disease in children who had multiple episodes of wheezing and who~     are at high risk for developing persisting asthma. These risks include a history of asthma in~     the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and~     other allergic diseases such as eczema or food allergies. Allergy Immunotherapy is not new~     and has been practiced for many years to treat asthma and environmental allergies in older~     children and adults, but has not yet been systematically studied in young children.~   "
193669|NCT01028547|"~     This is a randomised controlled double blinded clinical trial to determine the antiemetic~     efficacy and safety of either 8 mg of dexamethasone or normal saline (placebo) given 1 hour~     before induction of either spinal or general anaesthesia in 2 arms (of 150 each).~   "
193670|NCT01028534|"~     The aim of the present study is to compare the effects of different types of antihypertensive~     drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients~     with hypertension and obstructive sleep apnea who are not controlled well with their~     hypertension after continuous positive airway pressure therapy.~   "
193671|NCT01028521|"~     A first time in man, phase I study to assess the safety, tolerability and pharmacokinetics of~     single ascending doses of CM3.1-AC100 in healthy male volunteers.~   "
193672|NCT01028508|"~     This study will determine whether medications alone or medications and electroconvulsive~     therapy (ECT) work best to prevent depressive relapse and to improve quality of life for~     older people with severe mood disorders.~   "
193673|NCT01028495|"~     To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine,~     in subjects with metastatic pancreatic cancer.~   "
193674|NCT01028482|"~     Introduction:~      Postpartum depression (PPD) occurs in large numbers of women (between 10 - 20%) and~     substantially affects both their own well-being and their offspring's mental and emotional~     development. Whereas PPD is a form of major depression, its etiology is probably related to a~     combination of biological (hereditary, hormonal etc.), and psychological factors. In~     practice, most women suffering from PPD do not seek treatment, or are treated with~     psychotherapy alone due to concerns regarding pharmacotherapy. This is despite the obvious~     importance of reaching a rapid remission in these women. In fact, data regarding the~     treatment of PPD with antidepressants is surprisingly sparse and is limited to only one~     blinded and placebo-controlled study (with fluoxetine) and a number of studies without a~     placebo arm . The reason for the paucity of double-blinded placebo-controlled studies is~     probably due to 3 main limiting factors: Firstly, the reluctance of women to admit to and~     seek professional help due to depression, Secondly, the difficulty to administer~     antidepressant medication to lactating women, and, Thirdly, the ethical difficulties in~     designing a study with a real placebo group.~      In contrast to the very limited number of drug studies in this population, there are a number~     of studies that have shown the efficacy of psychotherapy in the treatment of PPD. Positive~     studies have been published using different types of psychotherapy, including cognitive,~     dynamic and interpersonal psychotherapy.~      The investigators propose to study the efficacy of psychotherapeutic treatment in women~     suffering from PPD with add-on sertraline in a randomized double-blind, placebo-controlled~     design. To overcome the difficulties described above in studying antidepressants in the~     postpartum period, the investigators propose to include active brief dynamic psychotherapy~     for all women. Furthermore, the investigators will selectively allow inclusion of women who~     only suffer from either mild or moderate major PPD (not severe / suicidal) .~      Hypothesis:~      The investigators hypothesize that women with PPD randomized to the arm receiving~     psychotherapy + active sertraline will show a greater response rate than the psychotherapy +~     placebo group. Furthermore, the investigators hypothesize that the difference in response~     between the 2 groups will demonstrate a significant early response in the active sertraline~     group.~   "
193675|NCT01028469|"~     The aim of this prospective, case series is to evaluate the surgical treatment of painful and~     disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.~   "
193676|NCT01028456|"~     This study is designed to investigate whether light therapy may be an effective treatment for~     some people with epilepsy. Light treatment is already an established treatment for~     depression. The chemical systems in the brain that are disrupted when someone becomes~     depressed, overlap with some of those that can be affected during some epileptic seizures.~     The investigators have designed this study to see whether light therapy may also lead to a~     decrease in seizures in people who have epilepsy.~      The study will be a placebo controlled trial. This means that half of the participants will~     receive a therapeutic dose of light therapy from a light box, whilst the other half will only~     receive a placebo light treatment.~   "
193677|NCT01028443|"~     The use of topical Cyclosporine A early after an episode of endothelial graft rejection after~     penetrating keratoplasty and continuing its administration for 6 months can reduce the course~     of that episode and recurrence of the rejection.~   "
193678|NCT01028430|"~     B-CLL is the most prevalent leukemia in the Western hemisphere, accounting for ~25% of all~     leukemia's (1). This disease occurs virtually exclusively in the aging population, with the~     median age of diagnosis ranging between the mid 60s and the early 70s. Indeed, its occurrence~     before the age of 50 is quite unusual. This increase in occurrence with age is not unique to~     B-CLL; rather, it is characteristic several B cell lymphoproliferative disorders (e.g.,~     non-Hodgkin's lymphoma, multiple myeloma). Gender and race also influence the development of~     B-CLL. Thus, the ratio of men: women is ~2:1 and the prevalence is increased in Caucasians.~     The rate of occurrence of B-CLL among Asians is significantly lower than for Caucasians and~     this does not increase with immigration to the West. DNA sequence analyses performed in our~     laboratory and in those of others indicate that B-CLL cells from unrelated patients share Ig~     V gene characteristics. These include the use of selected genes, the association of these~     genes with certain D and JH gene segments that code for unique CDR3 motifs, and the~     occasional occurrence of highly similar VHDJH + VLJL pairs. In ~50% cases, these rearranged~     genes are mutated, whereas in the others mutations are infrequent; this difference is related~     to the VH gene family used by the B-CLL cell.~   "
193679|NCT01028417|"~     LAY ABSTRACT~        1. Statement of the health problem or issue: Of the estimated 24,000 Canadians who will be~          diagnosed with lung cancer in 2008, 21,000 will die of their disease. Based on this~          cancer incidence and survival data, the most promising current strategy for improving~          outcome is screening and early detection. It is suggested that if lesions are discovered~          at an earlier stage of disease, they will have a higher likelihood of being treatable~          and therefore, survival will be improved. CT detection of growing small lung nodules,~          many of which are non-cancerous (benign), raises the possibility of lung cancer and thus~          causes anxiety in patients and referring clinicians. Unfortunately, confident separation~          of benign from malignant small lung nodules cannot be reliably achieved using CT or PET~          criteria. Pathologic diagnosis using needle or excision biopsy is usually required.~           Excision biopsy removes the entire nodule at one setting and eliminates the sampling~          error associated with needle biopsy, making it appealing to physicians and patients. To~          reduce post-operative pain and breathing difficulties, excision biopsy is often~          performed using minimally invasive surgery (video assisted thoracoscopic surgery, VATS).~          Finding small pulmonary nodules is often difficult with the minimally invasive camera~          (VATS) and a bigger incision (thoracotomy) is necessary in more than 60% of our~          patients.~           We recently developed a technique of using platinum micro-coils, which are inserted in~          the lung nodule using CT guidance, to locate the nodule with fluoroscopy and then excise~          it with VATS. We have completed a pilot study (n=75 nodules; 69 patients) to determine~          the effectiveness of this technique. Seventy three (97%) 4-24-mm nodules were~          successfully removed at fluoroscopically guided VATS excision.~        2. Objective of your project: To improve our ability to successfully excise small growing~          lung nodules with minimally invasive VATS surgery using CT guided micro-coil~          localization techniques.~        3. How will you undertake your work? We propose to conduct a randomized controlled trial to~          determine if the use of CT guided platinum microcoil markers for VATS excision of~          subcentimetre pulmonary nodules can reduce the rate of conversion to open thoracotomy~          from 50% to 10%.~        4. What is unique/innovative about your project? New image guided minimally invasive~          surgical technique for removing early growing cancers was developed at the Vancouver~          General Hospital and the University of British Columbia. This has been published in~          peer-reviewed journals and can potentially allow us to accurately locate and excise~          suspicious lung nodules~        5. Relevance to Lung Association's mission statement? Lung cancer remains a major health~          problem in Canada. Early detection and screening programs allow for discovery of nodules~          when they are still very small and therefore, likely curable. Excision biopsy removes~          the entire nodule at one setting and eliminates the sampling error associated with~          needle biopsy, making it appealing to patients and physicians. To reduce post operative~          morbidity, costs and volume of lung removed, excision biopsy is often performed using~          video assisted thoracoscopic surgery (VATS) techniques. Using a pilot project grant from~          the BC Lung Association we have developed a new technique that allows preoperative CT~          marking of the nodule and minimally invasive removal of the lesion. We hope that this~          technique will allow earlier treatment of lung cancers and improve survival in this~          devastating disease.~   "
193680|NCT01028404|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as~     tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.~      The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or~     insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2~     diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and~     placebo.~   "
193681|NCT01028391|"~     A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting~     plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in~     patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.~   "
193682|NCT01028378|"~     This purpose of this study is to evaluate the safety and effectiveness of a topography-based~     custom ablation treatment using the ALLEGRETTO WAVE® Eye-Q 400 Hz laser system for treating~     myopia and hyperopia.~   "
193683|NCT01028365|"~     The purpose of this research study is to learn a way to measure a person's fertility. After 1~     year of trying, 1 out of every 7 women will not be pregnant. This is called infertility. This~     results in significant distress and anxiety. Infertility is common; however, the~     investigators have no markers to predict who will be infertile. For couples diagnosed with~     infertility, the investigators have used blood and urine hormone levels (follicle stimulating~     hormone (FSH), inhibin B, and antimullerian hormone (AMH)) to tell us who will get pregnant~     with fertility treatment. The investigators don't know if these hormone levels can predict if~     regular people trying to get pregnant will be able to get pregnant. This study will try to~     determine if these hormone levels can predict fertility and infertility.~   "
193684|NCT01028352|"~     Many women with breast cancer who are treated with aromatase inhibitor medications develop~     aches and pains during treatment, and some develop numbness and tingling in their hands and~     feet. Some examples of aromatase inhibitor medications include anastrozole (Arimidex),~     exemestane (Aromasin), and letrozole (Femara). Frequently, pain medications do not work very~     well to relieve the pain. Duloxetine (Cymbalta) is a medication that was originally developed~     to treat depression. It has also been found to relieve pain that occurs in people with~     diabetes, fibromyalgia, arthritis, and other painful conditions. In this study we are testing~     to see if duloxetine will help treat the pain that can occur in women treated with aromatase~     inhibitors.~   "
193685|NCT01028339|"~     The purpose of this study is to determine whether hypertonic saline is as much effective as~     mannitol to treat intracranial hypertension after traumatic brain injury and has at least the~     same effects on PtiO2 and cerebral metabolism studied through microdialysis.~   "
193686|NCT01028326|"~     The World Health Organization has recommended that developing countries should incorporate~     pneumococcal conjugate vaccine (PCV) into their routine immunization schedules. The Kenya~     Ministry of Health anticipates introducing a new formulation of PCV, PCV10, into the routine~     childhood immunization schedule in 2010. In the areas of Kenya that have been designated to~     monitor the impact of vaccine, a catch-up campaign will be implemented to vaccinate children~     aged 12-59 months. PCV10 has been found to be safe and effective in infants. It is licensed~     for use in children up to 2 years of age, but its use as a primary series in children over~     age 12 months has not been evaluated. This study will assess the immunogenicity and~     reactogenicity of PCV10 first administered at an age of 12-59 months.~   "
193687|NCT01028313|"~     There is a clear need for effective, steroid-sparing agents for the management of chronic~     graft-versus-host disease (GVHD). Thus, agents like Histone deacetylase (HDAC) inhibitors,~     with the potential of decreasing pro-inflammatory events leading to GVHD without affecting~     graft-versus-leukemia (GVL), may have a central role in the prevention and treatment of GVHD.~      This study will look at the efficacy of panobinostat (LBH589), an HDAC inhibitor, in the~     treatment of patients with chronic GVHD who have failed corticosteroids. In this group of~     patients, effective steroid-sparing options are limited and are usually associated with~     profound immunosuppression and decreased GVL effect.~   "
193688|NCT01028300|"~     Degenerative disc disease (DDD) refers to a syndrome in which a degenerating disc causes~     chronic back pain, significantly impacting an individual's ability to function. The condition~     is most commonly diagnosed in the lumbosacral spinal segments L3-S1. The condition often~     starts with an injury to the disc space. The injury weakens the disc and creates excessive~     motion at the corresponding vertebral level. Over time, the segmental instability and~     associated neurological compromise combined with ongoing inflammatory processes that occur in~     and around the disc produce low back pain. The reparative processes in the disc are poor,~     thus the painful symptoms can become chronic.~      Premature degeneration at adjacent levels of the spine remains one of the more vexing~     problems facing spinal surgeons when advising relatively young people to consider lumbar~     fusion surgery. Stopping the motion changes the mechanics of the back (which is designed for~     motion and flexibility) and results in the transfer of the loads and stresses to the adjacent~     vertebral segments. It is therefore intuitive to pursue total disc replacement, which allows~     for the treatment of pain due to DDD while re-establishing motion and stability, load~     distribution, and restoring the disc height, as an alternative to spinal fusion surgery.~      The study hypothesis is that military personnel receiving Total Disc Replacement will return~     to the same level of active duty performance as at the time of their most recent successful~     physical readiness test.~   "
193689|NCT01028287|"~     This is a prospective open labeled trial examining the efficacy of ACTHar Gel (porcine ACTH)~     on the level of proteinuria in patients with diabetic nephropathy and nephrotic range~     proteinuria.~   "
193690|NCT01028274|"~     The purpose of this study is to assess the safety and efficacy of a natural health product~     among participants with elevated LDL cholesterol and triglyceride levels.~   "
193691|NCT01028261|"~     The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well~     tolerated in obese female subjects. The study will also provide information on how much~     ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other~     biological markers.~   "
193692|NCT01028248|"~     The purpose of this study is to determine whether ranibizumab (Lucentis) will be effective in~     reducing if not eliminating the macular edema associated with the disease, central retinal~     vein occlusion (CRVO).~   "
193693|NCT01028235|"~     The purpose of this study is to identify the prevalence of pathologic eosinophilic~     esophagitis (EoE) in the cohort of adult patients who present for specialty care in the~     gastroenterology clinics with complaint of difficulty swallowing (dysphagia). From this, the~     investigators will make recommendations regarding routine screening for the diagnosis in this~     cohort. The prevalence of EoE in patients presenting for specialty care in the~     gastroenterology clinics with the complaint of dysphagia is great enough that the diagnosis~     should be routinely screened against in this cohort.~   "
193694|NCT01028222|"~     The purpose of this study is to determine whether nilotinib is efficacious in the treatment~     of metastatic and/or inoperable melanoma harboring a c-Kit mutation.~   "
193695|NCT01028209|"~     The underlying goal of this study is to assess [18F] PBR06 PET imaging as a tool to detect~     microglial activation in the brain of Alzheimer Disease (AD), Parkinson Disease (PD) and~     Multiple Sclerosis (MS) research participants.~   "
194537|NCT01017120|"~     The purpose of this study is to assess safety and efficacy of a new foam formulation of~     tazarotene in subjects with acne vulgaris.~   "
193696|NCT01028196|"~     This study is aimed to evaluate the bipolar disorder symptoms in patients presented with~     schizophrenia, schizoaffective disorder or recurrent depression.~      Bipolar disorder is a group of mood disorders characterised by elevated or irritable mood~     episodes in patient's lifetime history accompanied by some additional symptoms. In this study~     modern bipolar disorders screening/assessment instruments will be used to explore the~     prevalence of bipolarity symptoms in patients who never been diagnosed with bipolar~     disorders. The results of this study could be useful for more accurate assessment of bipolar~     disorders prevalence in psychiatric patient population, could help to improve the diagnostics~     of bipolar disorders and management of bipolar patients.~   "
193697|NCT01028183|"~     The purpose of this research is to address the comparative effectiveness and harm of the~     therapeutics frequently given to pregnant women and their young infants including~     antibiotics, tocolytic agents, non-steroidal anti-inflammatory drugs, H2 blockers, and~     steroids.~      Our overall hypothesis is that the use of an existing electronic medical record with~     additional resources for precise data collection and 18 month follow up will successfully~     address current knowledge gaps in therapeutic effectiveness and relative therapeutic harm.~      We will use an existing electronic medical record into which detailed healthcare information~     is entered for over 100,000 newborns each year. These infants will comprise the Source~     Cohort. Nested within that database, we will prospectively enroll 10% of the population~     (10,000 newborns) as the Follow-Up Cohort.~      The current electronic medical record for the Source Cohort does not capture therapeutic~     dosing with sufficient precision to conduct comparative effectiveness research sufficient to~     change medical practice. The proposed research will: 1) ensure accurate data collection~     through electronic monitoring and real-time quality assurance evaluation in the Source~     Cohort; and 2) conduct 18 months post-hospital follow-up for neurologic outcomes and~     disability for the Follow-Up Cohort. We will complete assessments of neurologic outcomes and~     disability using an interactive web-based system, mail, telephone follow up, and in-person~     examination.~   "
193698|NCT01028170|"~     The purpose of this study is to compare high dose furosemide in combination with low volume~     hypertonic saline solution (2.4%) with intermittent pulse dose furosemide in patients with~     pre treatment kidney function impairment. The hypothesis is that it will provide effective~     diuretic response and have a beneficial effect on preservation of renal function as compared~     to pulse furosemide in patients with pre-treatment renal impairment (GFR < 60 mL/min).~   "
193699|NCT01028157|"~     STARS: Sistas Talking About Real Solutions is a health education intervention for~     African-American women, ages 18-29 aimed at reducing their risk for HIV. A total of 855~     subjects were recruited from three Kaiser Permanente Medical Centers. Members were randomly~     selected from the membership database and sent a letter via mail introducing them to the~     project and inviting them to participate. Letters were followed up with a phone call and~     potential participants were screened for eligibility. To be able to participate, participants~     had to be African-American, female, between the ages of 18-29, single, and have at least one~     act of unprotected sexual intercourse within the last 6 months. Members who were eligible and~     willing to participate completed a 1-hour baseline assessment survey; STD testing for~     Chlamydia, gonorrhea, trichomoniasis, and HPV; a vaginal swab that was used to determine if~     they had unprotected sex. They were then randomized into one of two study conditions: (1) a~     2-session HIV risk-reduction condition with a safer sex relapse prevention component (2) a~     1-session control condition in which participants receive general women's health information~     and brochures. Participants received a booster session at 6 and 9 months to reinforce~     intervention materials. Participants completed an assessment survey and received STD testing~     at 6 and 12 months. The primary aim of this project is to evaluate the efficacy of the HIV~     risk-reduction/safer sex relapse prevention condition relative to the health and nutritional~     control group in reducing HIV-associated sexual behaviors and incident STDs over a 12-month~     follow-up period is to implement.~   "
193700|NCT01028144|"~     The increasing prevalence of obesity in U.S. children and adolescents is a major health~     threat to our society, especially among minority and low social economic status (SES)~     populations. During adolescence physical activity (PA) decreases and is likely an important~     contributor to the increasing trend in childhood obesity rates. Little evidence suggests that~     school-based curriculum interventions lead to increases in overall PA. Thus, this proposal~     will evaluate the efficacy of an innovative motivational and behavioral skills after-school~     program for promoting increases PA among underserved adolescents (e.g., minorities, low SES).~     The motivational plus behavioral skills intervention is consistent with Self-Determination~     (Motivation) Theory and Social Cognitive Theory in that it emphasizes increasing intrinsic~     motivation and behavioral skills for PA. Adolescents in the intervention take part in~     developing the program, selecting physical activities that generate fun and interest, and~     generating their own coping strategies for making effective PA changes during a videotaped~     session. Preliminary data from our group demonstrates the feasibility of the motivational~     plus behavioral skills PA program for increasing moderate-to-vigorous PA (MVPA) in~     underserved adolescents in South Carolina. The proposed project will use a school-based~     nested cohort design to evaluate efficacy of a 17-week motivational plus behavioral skills~     program versus typical after-school program (general health education only) on increasing PA~     in underserved adolescents. Twenty-four middle schools (70 6th graders per school; N=1,680),~     located in South Carolina will be randomly assigned to one of two after-school programs. The~     study employs a nested cohort design, with schools, rather than individuals assigned to~     condition and will be analyzed using repeated measures analysis of covariance techniques as~     outlined by Murray. We will also examine psychosocial variables (PA self-efficacy,~     self-concept, motivation, social support, and enjoyment) as potential mediators of the~     intervention on changes in MVPA using regression and structural equation modeling techniques.~     This study will address an important public health problem that will have implications for~     decreasing obesity in underserved adolescents.~   "
193701|NCT01028131|"~     This study will develop:~        1. Develop the computer-based brief intervention and Contingency Management (CM)~          components, with repeated feedback from experts, prenatal clinic staff, and~          participants.~        2. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women~          to Brief Intervention, CM, combined, or control conditions.~        3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported~          smoking, breath carbon monoxide (CO), and urinary cotinine levels.~        4. Collect data regarding birth outcomes and evaluate the feasibility of various methods of~          post-partum follow-up.~   "
193714|NCT01027949|"~     This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to~     eligible patients with pulmonary arterial hypertension who have completed protocols~     TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any~     additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the~     long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise~     capacity after one year of treatment.~   "
193715|NCT01027936|"~     To collect three dimensional retinal measurements of the optic disc and the macula lutea on~     healthy normal subjects using the 3D OCT-1000 Mark II for the purpose of developing a~     normative database that is stratified by age.~   "
193702|NCT01028118|"~     Objective- Analysis of the health status of women who were or are victims of domestic and~     sexual violence seeking attention at the outpatient clinic for Endocrines Gynecology and~     Climactery - University of Sao Paulo General Hospital.~      To widen the comprehension of the binomial relationship violence-pathologies by~     professionals/staff who work in health services, offering women in such situation humane,~     comprehensive and qualified attention. Specific Objectives: decreasing the rates of domestic~     and sexual violence against women employing: prevention, health education and treatment -~     within the context of health services and public policies.~      Methodology - Project Type: Research in Action A- Attention to women in a situation of~     domestic and sexual violence during climactery; B- Information/Education/Communication (IEC)~     C- Behavioral Intervention (IC) D- Institutional Development (DI). Target Populations: 1.~     Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual~     violence; 2. Professional/staff who work in services attending women in sexual and domestic~     violent situations (health professionals, policemen, civil society) in areas located within~     the South Regional Health Coordination - SRC. To collect information, a semi structured~     questionnaire will be employed during seven months in 2009.~   "
193703|NCT01028105|"~     The purpose of this study is to evaluate the prevalence of pre-surgical patients who are MRSA~     carriers. From an evidence-based practice perspective, findings from this study can be~     considered in the evaluation of the hospital SOP mandating pre-surgical MRSA screening~     requirements for patients with scheduled surgeries.~      The central hypothesis to be addressed in this study is whether the MRSA colonization and~     subsequent post-operative infection are the equivalent in these populations.~   "
193704|NCT01028092|"~     This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then~     everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for~     elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).~   "
193705|NCT01028079|"~     The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (the~     study medication) by comparing it to placebo (the control group without active substance) or~     400 mg Ibuprofen (the control group with an active substance) in treating the symptoms of~     back pain. The study is designed to develop a treatment method against back pain which will~     have more advantages for patients than the methods that are currently available.~   "
193706|NCT01028066|"~     The simple knowledge that practices healthy lifestyle are important to reduce or prevent the~     progression of cardiovascular diseases it is not enough for effective changes accordingly. To~     nutritional education be successful, needs to promote changes in eating habits and not just~     transmit information. This is a behavioral intervention study in 200 consecutive patients~     submitted to percutaneous transluminary coronary angioplasty. The participants were~     randomized in two groups: intervention and control.~      The intervention was a dialogic nutritional counseling and the control arm was a traditional~     nutritional counseling.~      All participants will undergo long-term follow-up for cardiovascular events.~   "
193707|NCT01028053|"~     This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in~     identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from~     aMCI to a b-amyloid associated clinically probable Alzheimer's disease.~   "
193708|NCT01028040|"~     This is a single centre, open label, non-randomised study to access the safety, tolerability,~     pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to~     Japanese subjects.~   "
193709|NCT01028027|"~     This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and~     tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in~     the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).~   "
193710|NCT01028014|"~     Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions~     of American women. Women may develop these problems because the innervation of the muscles of~     the bladder and urethra are injured. Most research on treating these problems has focused on~     the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the~     innervation and muscle function of the urethra.~      Women with these symptoms may benefit from treatment with medications to improve their~     urethral function. However, to truly understand what types of medications will help women~     with these symptoms, the investigators wish to study how these medications affect innervation~     and muscle function in healthy women who do not have lower urinary tract symptoms.~   "
193711|NCT01027988|"~     Earlier studies have found that retinal photography could be very useful for evaluating the~     condition of microcirculation and the risk of cardiovascular diseases in patients. The~     architectural changes in retinal vascularisation strongly correlates with macrovascular~     remodeling. Also, recent founding suggests a possible close anatomical parallel between both~     the macrovascular and the microvascular blood.~      Our objectives are to assess (1) in which age and sex subgroups, if any, retinal vascular~     alteration in arterioles and venules can be predictive for cardiovascular morbidity and~     mortality; and (2) whether variations in arteriolar or venular caliber will predict better~     cardiovascular pathogenesis in normal and patient population. If the association between the~     diameter of the retinal vessels and the risks of cardiovascular disease is verified during~     this study, the impact on prevention would be enormous. The retinal microvascular change~     could become a powerful biomarker in the early detection of the cardiovascular pathogenesis~     and death risk~   "
193712|NCT01027975|"~     Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of~     fundoplication are performed, each has advantages and disadvantages. The Nissen operation is~     the most frequently performed procedure in the U.K., however it can be associated with~     post-operative dysphagia. The relative benefits between Nissen and other fundoplication~     techniques in children are still uncertain.~      The aim of our study was to compare the long-term outcomes following laparoscopic Nissen~     fundoplication with laparoscopic Thal fundoplication in children.~   "
193713|NCT01027962|"~     The purpose of this study is to examine whether an intensive computerized intervention~     targeted on improving central auditory and visual processing and executive functioning can be~     implemented in youths aged 10-19 with psychotic spectrum disorders, what developmental~     modifications are needed particularly for the younger participants, and whether it is~     possible to develop an appropriate, blinded control intervention.~   "
193717|NCT01027910|"~     The purpose of this research study is to determine the safety and maximum tolerated dose of~     PCI-24781 that can be given safely with doxorubicin (phase I) and the safety and efficacy of~     PCI-24781 when used in combination with doxorubicin (phase II) in patients with advanced~     sarcomas. The study drug, PCI-24781, is believed to regulate genes involved in tumor cell~     growth. The other study drug, doxorubicin, is considered a standard chemotherapeutic~     treatment for advanced sarcoma patients. We hypothesize that combining PCI-24781 with~     doxorubicin can overcome chemoresistance to doxorubicin.~   "
193718|NCT01027897|"~     The study hypothesis is to measure how the drug doripenem is cleared from the body of~     critically ill trauma patients. The investigators will measure blood drug concentrations and~     calculate how much the drug distributes in the body and how fast it is removed from the body.~     There is little information on how drugs are cleared in critically ill patients and the wrong~     dose of a drug could make it ineffective. The investigators will use this information to~     predict the most reasonable dose to treat infections effectively in these patients.~   "
193719|NCT01027884|"~     The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary~     function, motor function, muscle strength and quality of life in patients with DMD.~     Furthermore, the safety and tolerability of idebenone was assessed.~   "
193720|NCT01027871|"~     Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of~     treatment with a new basal insulin analog or with insulin glargine.~   "
193721|NCT01027858|"~     The investigators will conduct a proof-of-concept study to provide preliminary evidence of~     efficacy of aerobic-based exercise training for maintaining cognitive function, executive~     function, and everyday function in adults with mild vascular cognitive impairment.~   "
193722|NCT01027845|"~     This study will aim to evaluate the immunogenicity, safety and reactogenicity of~     GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when~     co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy~     Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of~     age.~   "
193723|NCT01027832|"~     Mechanically Ventilated patients in the intensive care unit (ICU) often present with fever,~     and purulent sputum, but without radiological evidence of pneumonia.~      These patients may have tracheobronchitis. Some suspect that this condition precedes the~     development of pneumonia. Antibiotic treatment in tracheobronchitis is controversial.~      The investigators will recruit patients with tracheobronchitis and randomize them into 2~     groups. One group will be treated with antibiotics and the other group will serve as control.~   "
193724|NCT01027819|"~     The purpose of this study is to compare the clinical and radiological outcomes of~     mobile-bearing with that of fixed-bearing in total knee arthroplasty.~   "
193725|NCT01027806|"~     The investigators leading hypotheses are:~        -  Oral therapy with montelukast may lead to improved sleep study findings in children with~          mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of~          adenoids and tonsils for OSAS.~        -  A significant proportion of the children with OSAS treated with montelukast will show~          reduced severity of OSAS, and this will remove the need for surgical intervention.~   "
193726|NCT01027793|"~     This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial~     dermabrasion in subjects that have recent stretch marks.~   "
193727|NCT01027780|"~     The purpose of the study is to better understand effects of the Mindfulness-Based~     Stress-Reduction (MBSR) program on the physical and emotional health and well-being of adults~     ages 65 and older.~      The effects MBSR may have on the immune system is investigated, including how these effects~     relate to factors such as perceived health, psychological well-being, age, personality, and~     mood.~   "
193728|NCT01027767|"~     The investigators hope to prove that radiation and surgical scarring does not result in~     changes that affect the MBI pattern 6-12 months after completion of treatment.~   "
193729|NCT01027754|"~     Patients in substance abuse treatment smoke four times more than non-substance abusers, and~     suffer high rates of tobacco-related disease and death. While many quit smoking treatments~     exist that have been shown to help non-substance abusers quit smoking, little is known about~     what treatments work for patients in substance abuse treatment. The drug varenicline~     (Chantix) has been shown to be more effective at helping people quit smoking than nicotine~     replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in~     patients in substance abuse treatment. The study aims to evaluate the feasibility,~     effectiveness and safety of varenicline, in combination with counseling, in methadone~     maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol~     and illicit drug use in methadone maintained smokers. We hypothesize that participants~     receiving varenicline will have higher abstinence from smoking than participants receiving~     placebo and that participants taking varenicline will not have significantly more adverse~     reactions than were described in the general population in other studies. We also hypothesize~     that compared to continued smokers, tobacco abstainers will be more likely to be abstinent~     from alcohol or illicit drugs.~   "
193730|NCT01027741|"~     The proposed study will:~        1. estimate the prevalence of need for cancer screening and prevention in a population of~          211 callers;~        2. determine whether cancer communication interventions delivered through 211 can increase~          use of breast, cervical and colon cancer screening, HPV vaccination, smoking cessation~          and adoption of smoke free home policies;~        3. determine how intensive an intervention is needed to bring about these changes; and~        4. determine whether the effectiveness of these interventions is enhanced when callers'~          basic needs have been addressed. Connecting these systems - 211, clinical and community~          cancer control programs and navigation services - should benefit disadvantaged~          Americans. The proposed study will evaluate the effects of this approach to eliminating~          cancer disparities.~      We hypothesize that the proportion of 211 callers who obtain a needed cancer control service~     will:~        1. differ significantly by study group as follows: N > T > P > CONTROL;~        2. vary significantly across study groups based on the intervention dose callers receive;~          and~        3. vary significantly across study groups based on whether callers' original need was~          resolved, the extent of their basic needs, and their perception of life as manageable~          and predictable (i.e., sense of coherence).~      (Dissemination Aim): Determine costs to 211 and effects on quality of service by offering~     cancer control referrals.~   "
193732|NCT01027715|"~     This is a prospective, randomized, single-center pilot trial of term and near term (≥ 36~     weeks gestation) infants with encephalopathy or seizures comparing a EEG Seizure Treatment~     Group or ESG with a Clinical Seizure Treatment Group or CSG.~      The investigators hypothesize that the accurate detection and treatment of EEG seizures will~     decrease the seizure burden and improve outcomes in newborn infants with seizures and/or~     hypoxic-ischemic encephalopathy (HIE).~   "
193733|NCT01027702|"~     The purpose of this study is to determine the ability of a donor lymphocyte infusion (DLI)~     given with methotrexate to hasten immune recovery without causing severe graft-versus-host~     disease (GVHD) in recipients who have had a T-cell depleted transplant.~   "
193734|NCT01027689|"~     This study tests the assumption that the bioavailability of alprazolam from a new sublingual~     formulation is the same as that from an existing commercial immediate release tablet~     formulation.~   "
193735|NCT01027676|"~     Gefitinib is an orally active epidermal growth factor receptor-tyrosine kinase inhibitor~     (EGFR-TKI) and produces 8-20% of response rates in patients with advanced non-small cell lung~     cancer (NSCLC). Vorinostat (suberoylanilide hydroxamic acid [SAHA]) is a small-molecule~     inhibitor of histone deacetylase (HDAC) and induces cell differentiation, cell cycle arrest,~     and apoptosis in several tumor cells. There is a strong synergistic antiproliferative effect~     of vorinostat in combination with gefitinib in NSCLC cells. Vorinostat increases expression~     of E-cadherin and ErbB-3, which results in increased sensitivity to gefitinib. Moreover,~     In-vitro studies have shown that vorinostat leads to acetylation and disruption of Hsp90,~     which may lead to decreases in activity of pro-growth and prosurvival client proteins (J Bio~     Chem 2005;280:26729, Br J Cancer 2006;95:S2). These findings suggest that combination of~     vorinostat with gefitinib may improve the efficacy of gefitinib in NSCLC.~   "
193736|NCT01027663|"~     The purpose of this study is to perform laboratory based studies to determine if the growth~     and development of the malaria parasite is effected by iron status of its host (the person~     infected with the malaria parasite). Iron deficiency affects over 500 million people~     including many pregnant women and children from areas of the world that are plagued by~     malaria. Some population based studies have suggested that iron deficiency protects people~     from getting malaria and this has raised questions about the wisdom of public health policies~     that provide universal iron supplementation in countries where malaria is common. We will use~     red blood cells and sera from patients with iron deficiency anemia, hereditary~     hemochromatosis and normal individuals who are taking iron supplements to look at this~     question in a very systematic way. This study should provide information for or against a~     possible mechanism by which iron deficiency may affect the malaria parasite. The results will~     contribute to efforts to develop evidence-based public health policies on iron~     supplementation policies in malaria-endemic areas.~      There are three different types of individuals involved in this study (1) people with iron~     deficiency anemia who will be taking iron supplementation (2) people without iron deficiency~     anemia who will be taking iron supplementation and (3) people with a condition called~     hereditary hemochromatosis who have an excess of iron in their bodies.~   "
193737|NCT01027650|"~     This study will evaluate the safety and efficacy of a single intravitreal injection of~     AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being~     conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a~     single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of~     AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2~     will enroll approximately 96 subjects who will receive a single masked intravitreal injection~     of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.~   "
193738|NCT01027637|"~     The purpose of this study is to evaluate the role of Alloderm tissue regenerative matrix used~     in many breast reconstruction operations. When this material is used in the abdomen it often~     stretches and sometimes needs to be replaced. Although we see good clinical results when used~     for breast reconstruction, there is no research regarding if or how the material changes in~     this location. The Alloderm is placed in the breast at the time the expander is placed,~     post-mastectomy. The expansion is started at the time of surgery and completed during a~     series of office visit. This process stretches the skin, underlying muscle and presumably the~     Alloderm. The goal of this study is to better understand the natural history of this material~     when used for breast reconstruction.~      Our objective is to measure changes in the dimension of the tissue matrix material after it~     has been placed in the breast. These objective findings will be supplemented with a patient~     questionnaire specifically designed for breast surgery patients.~      All patients will receive the standard preoperative work up, intraoperative procedures, and~     postoperative care indicated for patients undergoing implant breast reconstruction after~     mastectomy. Some of these patients will require use of the Alloderm to reconstruct the lower~     half of the breast pocket. This is already being done by plastic surgeons here at Henry Ford~     Hospital. The difference will be that the Alloderm tissue matrix used to reconstruct the~     lower part of the breast pocket for the study patients will have 4 millimeter metallic clips~     placed in it. Postoperatively these clips will be tracked by ultrasound done in the clinic.~     As the breast implant is normally expanded by adding saline, we believe the Alloderm matrix~     will stretch. The movement of these imperceptible clips will be tracked and measured to map~     the expansion of the matrix in response to the underlying implant stretching the overlying~     breast pocket and the skin envelope. The pattern of expansion will allow us to develop a~     mathematical model to describe the stretch pattern of Alloderm matrix used in breast~     reconstruction. This information will be supplemented with a validated questionnaire~     specifically designed by breast surgery patients. This will give us both an objective~     dimensional change in the breast reconstruction as well as a patient-centered evaluation of~     the reconstruction process.~   "
193739|NCT01027624|"~     This is a multi-centre survey of patients who are currently on lipid lowering pharmacological~     treatment in South Africa.~   "
193740|NCT01027611|"~     There are currently several different commercially available topical eye drops and gels used~     to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack~     is performing a research study to evaluate three commercially available topical anesthetics~     (eye numbing treatments) to determine if individuals have a preference for one over the~     other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride~     (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4%~     lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5%~     lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT~     experimental medications. They are all commercially available topical anesthetics currently~     used in our offices and their use is widespread among retina specialists throughout the~     United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask~     you to grade your level of pain associated with the injection procedure. Answering these~     questions should take less than one minute of your time and your identity will NOT be~     revealed with the results of this study. The results of this study will be used to inform~     doctors which eye anesthetics patients find most effective for pain control during eye~     injections.~   "
193763|NCT01027312|"~     To determine the clinical usefulness of a refined third-generation instrument - The~     Assessment of Ability Related to Vision (AARV) in establishing the amount of disability,~     charting the detrimental effects of progressive disease and establishing the beneficial~     effects of treatment~   "
193743|NCT01027572|"~     Rationale. The investigators hypothesize that bilateral electrical central thalamic~     stimulation of patients in Vegetative State and Minimally Conscious State from at least 6~     months could improve the level of responsiveness.~      Aims. Evaluate the efficacy of bilateral electrical central thalamic stimulation in patients~     in Vegetative State and Minimally Conscious State.~      Study Design. Patients in Vegetative State and Minimally Conscious State from at least 6~     months because of traumatic brain injury, hypoxic or ischemic brain injury will be evaluated~     to confirm the diagnosis according to the recent literature criteria. Then patients will be~     investigated by magnetic resonance (MRI), EEG and evoked potentials to evaluate eligibility.~     Patients included into the study will be implanted with electrodes, targeting the~     centromedian/parafascicularis nucleus complex of the thalamus bilaterally.~      In the following months patients will be repeatedly evaluated using the CRS-R and Coma/Near~     Coma scales and the neurophysiologic parameters (EEG, evoked potentials) to assess the~     effects of thalamic stimulation. fMRI,DTI and MRS will be performed prior and after thalamic~     stimulation.~   "
193744|NCT01027559|"~     The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT)~     has the same healing effect on the brain for people with depression as traditional~     anti-depressants do, to find out more about the causes of depression and why people differ in~     the extent of problems caused by depression, and to determine if certain differences in genes~     within populations are related to clinical symptoms. We hypothesize that CBT will have the~     same healing effect on the brain as antidepressants; that differences in brain activations~     created by the various tasks and genetic differences will help us understand differences in~     the type and severity of symptoms among the depressed subjects.~   "
193745|NCT01027546|"~     The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the~     surgical procedure used was identical in all cases.~   "
193746|NCT01027533|"~     The purpose of the study is to determine whether implantation of a multifocal IOL with a~     modified addition at lens plane(Restor +3) results in better intermediate visual acuity with~     similar performance at distance and near compared to other multifocal IOL with similar design~     but with higher addition at lens plane. Patient's contrast sensitivity of vision and best~     reading distance following Restor +3 implantation were also assessed.~      Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at~     lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity~     with similar distance and near visual acuity after cataract surgery.~   "
193747|NCT01027520|"~     Participants of this study will include burns requiring skin graft to hand(s). After informed~     consent, an occupational therapy evaluation will be performed. Participants will consent to~     surgery, in which skin graft will be applied by physician during surgery, occupational~     therapy will apply coban dressing. Participant will seen daily by occupational therapist~     during hospitalization for active range of motion to hand(s). Occupational therapist will~     measure range of motion of hand(s) and physician will assess graft success at one and four~     days after surgery and at three out patient clinic visits. Hand strength will also be~     measured at three out patient visits.~      Does the initiation of range of motion on post operative day kone with coban dressing improve~     hand function without compromising graft success?~   "
193748|NCT01027507|"~     To study the postprandial alterations in hemodynamics and blood pressure in relation to~     gastric emptying rate, postprandial blood glucose, plasma concentrations of insulin, satiety~     in healthy subjects.~   "
193749|NCT01027494|"~     The purpose of this observational study was to evaluate the effects of a topical~     fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media~     through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in~     the nose, and in the throat.~   "
193750|NCT01027481|"~     In a recent study we could show that the early retinal venous vasoconstriction after grid~     photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual~     outcome after three months. This could be of clinical importance, because the degree of~     vasoconstriction might be an early marker of treatment success, compatible with the idea that~     hypoxia is the major trigger of VEGF in BRVO. The present study evaluates the response of~     retinal vessel diameters to anti VEGF treatment with lucentis in patients with BRVO. This is~     done in an effort to gain insight into the retinal hemodynamic consequences of anti VEGF~     treatment in BRVO. The hypothesis that anti VEGF treatment is associated with a~     vasoconstrictor response in retinal vessel in patients with BRVO is tested.~   "
193751|NCT01027468|"~     200 eyes with each subtype of neovascular age-related macular degeneration will be included~     in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual~     acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT)~     will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes~     (group 1) were compared to the data of eyes that had undergone prior treatment with~     photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).~   "
193752|NCT01027455|"~     In laparoscopic (key-hole) surgery, the use of cold dry carbon dioxide gas to inflate the~     abdominal cavity for the creation a clear operating field, results in damage to the cavity~     lining, known as the peritoneum. This has been associated with negative effects on~     post-operative recovery. Adult studies using warm humidified insufflation gas have indicated~     possible decreased post-operative pain, reduced narcotic analgesia requirements, decreased~     fogging of the laparoscopic camera lens, and reduced time to return to normal activities.~     Cold dry gas during laparoscopic surgery also has potential to cause abnormal decrease in~     body core temperature (hypothermia). This has been established by trials in adult humans and~     animal models. The WARMIST study aims to investigate for whether warm humid gas insuflation~     during laparoscopic removal of the appendix in children reduces intraoperative temperature~     variations, post-operative pain (indicated by morphine usage and pain scores), length of~     hospital stay and degree of camera lens fogging, and speed post-operative recovery compared~     to using cold dry gas insufflation.~   "
193764|NCT01027299|"~     This trial will investigate the clinical and haemodynamic effects of temporary biventricular~     pacing after cardiac surgery. Subjects with poor left ventricular systolic function will~     receive either temporary biventricular pacing or 'standard' post-operative pacing for 48~     hours.~      The investigators hypothesis that reversal of cardiac dyssynchrony will improve tissue~     perfusion and cardiac haemodynamics after surgical revascularisation. This will shorten~     post-operative recovery in cardiac ITU.~   "
193753|NCT01027442|"~     Introduction:~      The use stereolithographic (SLA) guides may provide significant benefits in simultaneous~     placement of multiple implants, especially in large edentulous areas lacking anatomic~     landmarks for surgical reference. Planning of the implant positions prior to surgery may~     shorten the duration of the surgery spent by exploring and determining the suitable implant~     location on the edentulous alveolar crest in the standard technique . Previous studies have~     demonstrated the use of many SLA guide in this manner, however; most were designed to be used~     as placed on the alveolar crest (bone-supported) following a flap exposure, and there was no~     depth-control of the osteotomy drills. Further advances in stereolithography allowed flapless~     surgeries to be performed via mucosa-supported guides (Rosenfeld, et al. 2006c, Tardieu, et~     al. 2007). The use of these guides eliminates not only the time required for incision and~     flap exposure but post-operative patient morbidity and discomfort may also be reduced, due to~     the non-invasive nature of the procedure. The aim of this study is to investigate the~     accuracy, surgical and post-operative complications and post-loading outcomes of implants~     placed by the conventional and aforementioned computer-aided methods.~   "
193754|NCT01027429|"~     This trial evaluates primary care clinic-based simplified antibiotic therapy options for~     young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where~     hospital referral is frequently refused by families.~   "
193755|NCT01027416|"~     This study will help to understand the interaction between estrogen receptor-alpha (ER alpha)~     and tumor suppressor protein p53 as well as impact on patient tumor gene expression in~     response to the hormonal therapy Tamoxifen. This information may eventually help select the~     appropriate therapy for future patients with similar cancer.~   "
193756|NCT01027403|"~     Despite advances in medical technology, heart failure remains a major cause of illness on a~     global scale. Medical research, over recent years, has shown that adult stem cells (as~     opposed to embryonic stem cells) are present in most organs of adult humans. Their exact~     function is however poorly understood. An improved understanding of what these stem cells do~     and how they work is essential if effective stem cell treatments are to be developed in~     future.~      The project seeks to examine the levels of a number of different types of stem cells in~     patients with heart failure, compared to healthy volunteers. The project also aims to measure~     stem cell levels in patients with heart failure at the time of a sudden worsening in their~     condition and then later in the same patients following recovery.~      The project entails the taking of blood samples in order to measure the stem cell levels in~     the blood. The study does NOT involve any form of treatment with stem cells. Two groups of~     patients will be studied; patients with heart failure and healthy volunteers.~   "
193757|NCT01027390|"~     Musculoskeletal disorders are frequent among office workers especially in the neck/shoulder~     area.~      The hypothesis is, that specific strength training of the neck/shoulder muscles will~     alleviate the pain.~      The two sub-hypotheses are~        1. Alleviation of pain is independent of training frequency~        2. Alleviation of pain is higher following supervised training vs training with initial~          instruction only~   "
193758|NCT01027377|"~     The study is to investigate the safety, tolerability, and pharmacokinetics (the determination~     of the concentration of the administered drug in blood over time) of recombinant Factor VIII~     Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.~   "
193759|NCT01027364|"~     The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc;~     to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of~     prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding~     episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and~     participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study~     were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX~     (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week);~     to evaluate participants' response to treatment; to evaluate rFIXFc consumption.~   "
193760|NCT01027351|"~     The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of~     this extension study will be to explore antibody persistence at approximately 40 months of~     age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV~     NZ administered to subjects at approximately 40 months of age. Antibody persistence will be~     subsequently measured at 18-20 months after these booster doses when the subjects are 60~     months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be~     recruited in the study to serve as a baseline comparator for assessing antibody persistence~     at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ.~     Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if~     they have not already received these vaccines prior to enrollment.~   "
193761|NCT01027338|"~     This is a pilot randomized controlled trial of feasibililty and prelimnary effects of a 12~     week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary~     disease~   "
193762|NCT01027325|"~     The alarming increase in the prevalence of obesity is a cause of great concern given its~     association with many adverse health conditions, including insulin resistance and type 2~     diabetes, which are associated with increased cardiovascular disease (CVD) risk. The primary~     objective of this project is to identify effective dietary strategies, focused on~     carbohydrate quantity and starch digestibility, to improve outcome variables associated with~     CVD risk in insulin resistant individuals who express components of the atherogenic~     lipoprotein phenotype (ALP). Current dietary guidelines emphasize substitution of~     carbohydrate calories for total and saturated fat calories for prevention and management of~     chronic disease. Yet, we and others have shown that high-carbohydrate diets increase the~     expression of the ALP, characterized by increased plasma triglycerides, reduced HDL~     cholesterol, and increased levels of small, dense LDL particles, and that this phenotype is~     reversed by moderate carbohydrate restriction. We have also shown that expression of stearoyl~     coenzymeA desaturase (SCD), an enzyme involved in triglyceride synthesis, is reduced with~     carbohydrate restriction and that this change is correlated with plasma triglyceride~     response. While carbohydrate restriction is effective for management of ALP, the role of~     starch quality has not been addressed. Furthermore, there has been no study of the effects of~     resistant vs. digestible starches incorporated into high- vs. lower carbohydrate diets. Since~     isolated reports suggest that increased intake of resistant starch lowers plasma~     triglycerides and postprandial insulinemia, we hypothesize that starch quality is an~     important determinant of components of ALP, and that this may be mediated in part by reduced~     adipose tissue SCD expression. Aim 1 and of this proposal will address this hypothesis by a~     controlled dietary intervention in 52 insulin resistant men and women in which changes in~     plasma lipids, lipoproteins and lipogenic gene expression will be determined after~     substituting resistant starch for digestible starch in a high- vs. lower-carbohydrate diet.~     In Aim 2, the fasting and postprandial glucose and insulin responses to a resistant vs.~     digestible starch meal will be measured to test the hypothesis that starch digestibility~     improves glycemic and insulinemic control in a way that relates to diet-induced changes in~     plasma lipids and lipoproteins.~   "
193765|NCT01027286|"~     Vitagel® is an FDA approved class III medical device. It is a surgical hemostat, which has~     been shown to control bleeding during orthopaedic, cardiac, hepatic, and general surgical~     procedures. The product is a thrombin/collagen suspension which works in combination with the~     patient's own plasma to form a fibrin/collagen clot.~      The present prospective, randomized controlled trial is designed to evaluate the efficacy of~     Vitagel® for reducing blood loss and pain in patients managed with unilateral total knee~     arthroplasty (TKA). It is hypothesized that the use of Vitagel® may lead to less blood filled~     knees, and thus to a greater improvement in postoperative pain scores when compared to the~     control group. The two arms of the study will include:~        1. experimental group in which Vitagel® is used unilateral TKA~        2. control group representing our current standard of care (no Vitagel®)~      A comparison of the functional and clinical results between these two groups will be~     conducted using several outcome measures including the KOOS, SF-12 version2 and pain scores~     through the previously IRB approved OrthoMidas registry. The primary variable of interest is~     blood loss, based on hemoglobin drop during the postoperative hospital stay. Of secondary~     interest will be; 1) pain levels in the PACU, 2) pain scores for all postoperative days, 3)~     average pain for the entire hospital stay, 4) length of stay, 5) patient satisfaction at~     discharge, 4 weeks postoperative, and 12 weeks postoperative, and 6) functional scores at 4~     and 12 weeks postoperative.~   "
193766|NCT01027273|"~     The purpose of this study is to evaluate if a peer-led stroke recurrence prevention~     intervention, versus usual care, will help reduce risk factors for recurrent strokes among~     adults in Harlem.~   "
193767|NCT01027260|"~     Patients suffering from Irritable Bowel Syndrome with predominant constipation will be~     provided with the study medication. The study medication will be evaluated for its efficacy~     in relieving the symptoms~   "
193768|NCT01027247|"~     Frequently glaucoma is not controlled with clinical treatment (eyedrops) or laser surgery~     to control your eye pressure. If this raised pressure is sustained over a long period of time~     it can lead to permanent damage to the optic nerve (glaucoma) and in severe cases it can~     result in blindness. You also have cataracts, an opacification of the natural lens inside the~     eye that is impairing your vision. To prevent further vision loss due to glaucoma, your~     doctor has recommended glaucoma filtration surgery to lower your eye pressure, and cataract~     surgery at the same time to improve your sight.~      The use of the anti-metabolite (Mitomycin-C) during the operation is currently the drug of~     choice to improve surgical outcome for glaucoma filtration surgery. Mitomycin-C is a potent~     antiscarring agent that reduces the amount of scar tissue produced after surgery which leads~     to better control of eye pressure. Although this potent drug is effective in increasing~     surgical success, its use is related to a higher risk of post surgical complications, some of~     which are sight threatening.~      The Collagen Matrix Implant is a biodegradable implant (absorbed naturally by tissue), made~     from porcine collagen, which reduces scar tissue formed after glaucoma filtration surgery~     without the use of Mitomycin-C. This means that you could be less likely to have a failed~     glaucoma filtration surgery, and consequently, a poor eye pressure control. In addition, the~     risk of surgical failure may be reduced because with this technique, we will not be using~     potent drugs. However, the long-term effect of the OculusGenTm implant in glaucoma filtration~     surgery is not fully known.~      The aim of the study is to determine whether the OculusGenTm implant can equal the success~     rate of Mitomycin-C in controlling eye pressure, without the potentially sight threatening~     complications associated with Mitomycin use. And at the same time, this study aim to~     determine if the implant can reduce potential complications related to glaucoma surgery when~     compared to the combined surgery augmented with anti-proliferative agents.~      This study will recruit 66 subjects from patients attending the Singapore National Eye Centre~     over a period of 12-24 months.~   "
193769|NCT01027234|"~     The main purpose of this study is to assess the safety and tolerability of AZD8418 after~     single increasing oral doses.~      Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the~     study drug enters and leaves the body and how your body acts on the study drug) of AZD8418.~     Part B of the study will assess the effect of food on the safety and pharmacokinetics of~     AZD8418.~   "
193770|NCT01027221|"~     Principal purpose of the study is the determination of an active local external beam~     radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.~   "
193771|NCT01027208|"~     To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer~     who have completed the previous Phase II study (CA163-107)~   "
193772|NCT01027195|"~     The present prospective, single-center, clinical trial is designed to evaluate the hemostatic~     efficacy of the hemostatic sealer Aquamantys 6.0™ in patients managed with total hip~     arthroplasty (THA). It is hypothesized that Aquamantys 6.0™ can improve hemostasis following~     total hip arthroplasty. Comparison of the functional and clinical results between THA~     patients having been exposed to Aquamantys 6.0™ versus a control group will be analyzed using~     several outcome measures including the Harris Hip Score and a pain scale. The primary~     variable of interest is transfusion requirements - specifically, number of patients managed~     with blood transfusion during the hospital stay after surgery. However, of secondary interest~     will be: 1) number of units transfused, 2) estimated intraoperative total blood loss, 3)~     change in pre- and post-operative hemoglobin levels, 4) total narcotic usage during hospital~     stay, 5) length of stay, 6) functional and pain outcomes (Harris Hip Score and Pain Scale),~     and 7) adverse events.~   "
193773|NCT01027182|"~     The investigators hypothesize that the concentration-time profile of raltegravir is different~     in cells than that in plasma. Intracellular raltegravir concentrations may be higher and its~     half-life longer than in plasma. This may explain the efficacy of raltegravir despite~     variable plasma concentrations.~   "
193774|NCT01027169|"~     The primary purpose of this study is to investigate the pharmacokinetics (behavior of the~     compound in the body) of safinamide in patients with different degrees of hepatic (liver)~     impairment in comparison to matched subjects with normal hepatic function.~   "
193775|NCT01027156|"~     The purpose of this study is to determine whether a High Intensity exercise intervention can~     elicit cardiovascular disease protection in adolescents.~   "
193776|NCT01027143|"~     This project will assess the effectiveness of omega-3 fatty acid supplementation in~     controlling asthma symptoms among obese asthmatics, and will assess if a person's genes~     influence response to treatment (personalized medicine). This project may improve our ability~     to treat asthma and our understanding of the link between obesity and asthma.~   "
193777|NCT01027130|"~     The purpose of this study is to show that a certain protein called haptoglobin protects~     against preeclampsia which is a common pregnancy complication.~   "
193850|NCT01026181|"~     This is a prospective case series study; all morbidly obese patients that need surgical~     management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic~     Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic~     gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The~     outcome measures will be percentage of excess weight loss, BMI, operative time, hospital~     stays, complications and improvement of comorbidities.~   "
193778|NCT01027117|"~     This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in~     healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at~     the discretion of the sponsor. Three treatments are:~      Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed~     with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood~     samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours~     post dose in each period. Tolerability and safety will be assessed by reported adverse events~     during each study period.~   "
193779|NCT01027104|"~     The purpose of this project is to evaluate the efficacy of a web-based curriculum designed to~     teach pediatric practitioners how to provide injury prevention anticipatory guidance,~     emphasizing firearm injury prevention in a clinic setting. Data will be collected regarding~     the curriculum's effectiveness using a web-based questionnaire which will be administered to~     pediatric residents prior to, immediately post, and six months following completion of the~     curriculum. Pre- and post-test questionnaires will be compared. Residents will also be asked~     to evaluate the curriculum by completing a survey. We hypothesize that the curriculum will~     improve residents' knowledge, attitudes and beliefs, and self-efficacy regarding firearm~     injury prevention anticipatory guidance.~   "
193780|NCT01027091|"~     Hypocalcemia is the complication, after total thyroidectomy, that usually determines the~     length of hospital stay.Serum calcium levels is a quick and cost-effective practice to~     recognise hypocalcemia in the postoperative follow up.~      OBJECTIVE: The objective of this perspective study is to determine if consecutive~     postoperative serum calcium levels early after total thyroidectomy can be used to identify~     patients who are unlikely to develop significant hypocalcemia and can be safely discharged~     within 24 to 48 hours postoperative.~   "
193781|NCT01027078|"~     The investigators hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free~     of any cardiovascular disease will have early microcirculatory changes that are unique to~     OSA, and therefore would resolve with treatment of OSA.~   "
193782|NCT01027065|"~     This study is designed to evaluate the safety of biological active dose of a new experimental~     drug, IL-7, in combination with anti viral therapy and vaccine in patients with Hepatitis B~     chronic infection.~   "
193783|NCT01027052|"~     Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly,~     in response to biotic or abiotic stresses such as infections, wounding, UV irradiation,~     exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that~     the molecular basis for the protective action of polyphenols in plants is their antioxidant~     and free radical scavenging properties. These numerous phenolic compounds are major~     biologically active components of spices, aromas, essential oils, and traditional medicines.~     In order to investigate the impact of spice polyphenols on postprandial cytotoxic lipid~     peroxidation products (MDA) levels in humans, the investigators propose to achieve the~     following specific aims using a randomized crossover study design:~        1. To determine the effect of a ground beef patty meal with and without spices on~          postprandial levels of plasma malondialdehyde (MDA).~        2. To determine the effect of a ground beef patty meal with and without a spice blend on~          MDA accumulation in urine.~      This study will determine whether spice polyphenols exert a beneficial effect by inhibition~     of the absorption of MDA. These findings may help to explain the potentially harmful effects~     of oxidizable fats found in foods and the important benefit of dietary polyphenols in~     ameliorating this potentially harmful effect.~   "
193784|NCT01027039|"~     The purpose of this study is to examine if there is a difference between glaucoma patients~     having background music and not having background music before visual field testing.~   "
193785|NCT01027026|"~     The investigators will make a prospective study in which they will look at the economics and~     security of the treatment of patients with acute coronary syndrome.~      The investigators want to do a randomized trial. One group will be treated as they have been~     treated at Ullevål University Hospital (UUS) in recent years, and the other group will be~     returned to their refering hospital the same day. The objective of this study will be to~     provide increased knowledge about whether the rapid discharge from the intervention center is~     associated with differences in costs or security.~   "
193786|NCT01027013|"~     The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension~     for the treatment of patients with dry-eye.~   "
193787|NCT01027000|"~     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop~     the growth of cancer cells. It may also stop the patient's immune system from rejecting the~     donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     The donated stem cells may replace the patient's immune cells and help destroy any remaining~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus,~     and methotrexate after the transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well donor stem cell transplant works in~     treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.~   "
193788|NCT01026987|"~     Patients who have not had adequate blood count recovery post related or unrelated stem cell~     transplant will be given a boost of T-cell depleted, enriched stem cells to hopefully~     improve their blood counts.~   "
193789|NCT01026974|"~     The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension~     study will be to explore antibody persistence in children at approximately 40 months of age~     and to evaluate the safety, tolerability and immunogenicity of a booster dose of rMenB±OMV NZ~     administered to subjects at approximately 40 months of age. Antibody persistence will be~     subsequently measured at 18-20 months after these booster doses when the subjects are 60~     months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be~     recruited in the study to serve as a baseline comparator for assessing antibody persistence~     at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ.~     Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations , if~     they have not already received these vaccines prior to enrollment.~   "
193790|NCT01026961|"~     This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500~     mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy~     volunteers.~   "
193791|NCT01026948|"~     In order to confirm the feasibility of home monitoring with Monica AN 24, a licensed portable~     device for measuring fetal and maternal electrocardiogram (ECG), and the feasibility of~     inpatient monitoring with Monica AN 24 in patients with Propess (a vaginal licensed drug~     delivery system used for induction of labour), we will perform a pilot study that will~     include 20 women in each arm.~      Feasibility of monitoring with Monica AN 24 both in hospital and at home will be confirmed in~     a pilot study. The success will be defined as at least 10 minutes of continuous satisfactory~     trace in any given hour in at least 80% of the patient.~      A main study will then be conducted to assess the feasibility and acceptability of the~     Propess and Monica AN24package of care for women undergoing induction of labour.~      The research questions are:~        1. Is outpatient induction with continuous monitoring technically feasible?~        2. Does the Propess and Monica AN24 care package of care provide adequate clinical~          information in line with the UK National Institute of Clinical Evidence (NICE) Guideline~          for Induction of labour?~        3. Is outpatient induction a concept that appeals to women?~        4. What do women consider to be the advantages and disadvantages of this package of care?~        5. What would women consider to be positive and/or negative outcome in future clinical~          trials of outpatient induction?~        6. Do fetuses with abnormal electrocardiogram (ECG) patterns have evidence of subclinically~          impaired cardiac function (feasibility study)?~        7. Do elevated concentrations of white blood cell components in the umbilical cord blood at~          birth influence fetal electrocardiogram (feasibility study)?~   "
193792|NCT01026935|"~     For the present study, 400 consecutive men with unilateral primary inguinal hernia are~     randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or~     light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks~     without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain~     than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as~     well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are~     needed, which may compensate for its higher cost. The patients are blinded to which mesh they~     receive.~   "
193793|NCT01026922|"~     This study will test a new medical device called the SmartPill GI Monitoring System, which is~     now used to diagnose gastric motility disorders in adults, in children. The study will~     compare the SmartPill capsule findings to antroduodenal manometry (ADM), which is a standard~     procedure currently used for the evaluation of gastric and duodenal motility in children. The~     ADM studies will be done for clinical purposes and only if recommended by the patient's~     gastroenterologist. The research portion of the study is limited to the use of SmartPill.~   "
193794|NCT01026909|"~     Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur,~     resulting in significant hip pain and potential long term disability. This study represents a~     single center, randomized, prospective, controlled study comparing the treatment of LCP with~     an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional~     nonoperative treatment.~   "
193795|NCT01026896|"~     This study will examine whether mentally rehearsing moving one's affected arm after stroke~     will improve the quality and amount of affected arm movement. The study will enroll 100~     people who have experienced a stroke > 1 year ago, and who still have difficulty moving their~     affected wrists and hands. Eligible subjects also cannot have any implanted devices or metal~     above the waist. Each patient will receive 10 weeks of therapy targeting their affected arms.~     Half of the subjects will also be administered mental rehearsal of the exercises that they~     are physically performing, while the other half will be administered stroke information and~     information on additional exercises that they can perform targeting their affected arms.~     Tests of arm movement and use will be given before and after intervention, as well as 3~     months after intervention, to measure response to these interventions. We will also~     administer brain scans before and after intervention. We hypothesize that people receiving~     the mantal and physical rehearsal will show larger arm movement and use changes.~   "
193796|NCT01026883|"~     The hematocrit level is defined as the ratio of plasma volume and red blood cell mass.~     Determination of this level is important for the diagnosis and follow-up of various~     hematological and renal disorders. In clinical practice, automated hematology analyzers are~     commonly used.~      Recently, a new method for hematocrit level determination has been introduced which employs~     layered resonant piezoelectric sensors. In the present study this technique will be applied~     in blood samples of healthy subjects and compared to a standard laboratory method.~   "
193797|NCT01026870|"~     Mometasone furoate (MF) is a synthetic glucocorticosteroid that, when administered to asthma~     patients with a dry powder inhaler (Asmanex® Twisthaler®) at dosages of 100 to 400 mcg twice~     daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce~     frequency and severity of exacerbations by reducing airway inflammation, with a relatively~     low potential to cause systemic side effects such as hypothalamic-pituitary-adrenal (HPA)~     axis suppression.~      An experimental formulation of MF 100 mcg delivered twice daily via a pressurized~     metered-dose inhaler (MDI) also has been shown to be effective in improving lung function of~     asthma patients as measured by forced expiratory volume in 1 second (FEV1). This trial is~     designed to verify the effectiveness of twice daily MF MDI 100 mcg in treating asthma in~     adults and adolescents previously treated with low dosages of inhaled corticosteroids (ICS),~     as measured by improvement in morning FEV1 and time to first asthma exacerbation over 12~     weeks of treatment.~   "
193798|NCT01026857|"~     The purpose of this study is to determine whether Propionyl-L-carnitine administration may~     ameliorate the illness in patients affected by mild to moderate ulcerative colitis already in~     treatment with one of the standard treatments (corticosteroids excluded).~   "
193812|NCT01026675|"~     The working hypothesis of this proposal is that screening for gestational diabetes mellitus~     as early as the 1st trimester is efficient for detecting the forthcoming presence or absence~     of gestational diabetes mellitus. The investigators long-term goal is the prevention of~     gestational diabetes mellitus onset i.e. the prevention of progression to gestational~     diabetes mellitus, in order to enable delivery of appropriate counselling, diagnostics and~     treatment for pregnant women, as well as to improve pregnancy outcomes. Therefore, robust 1st~     trimester screening criteria is needed.~      The overall objective of this proposal is to determine an accurate and valid 1st trimester 1h~     post 50g oral glucose challenge test plasma glucose cut-off value that is predictive of~     gestational diabetes mellitus onset.~   "
193799|NCT01026844|"~     Erlotinib is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block a protein~     called epidermal growth factor receptor (EGFR). EGFR may control tumor growth and tumor cell~     survival. EGFR is found on the surface of many types of cancer cells, including non-small~     cell lung cancer (NSCLC). Erlotinib is approved by the Food and Drug Administration (FDA) for~     the treatment of NSCLC. Hydroxychloroquine (HCQ) is a drug approved by the FDA for treatment~     of malaria, rheumatoid arthritis, and several other diseases but is not currently thought of~     as a cancer treatment. Previous laboratory studies suggests that HCQ may have an anti-cancer~     effect by itself in some situations, particularly when EGFR TKI drugs have been useful in the~     past against the tumor. The two drugs together may be able to fight lung cancer in cases~     where erlotinib is no longer effective by itself. The purpose of this research study is to~     determine the highest dose of HCQ that can be given safely in combination with erlotinib. We~     will also begin to look at whether HCQ plus erlotinib helps treat cancer that have become~     resistant to TKI treatment after initially responding.~   "
193800|NCT01026831|"~     This study was to compare the safety and efficacy of the preservative-free formulation of~     0.0015% MK2452 (tafluprost) and preservative-free 0.5% timolol maleate in patients with~     open-angle glaucoma and ocular hypertension. This study was to demonstrate that the~     preservative-free formulation of 0.0015% tafluprost is non-inferior to preservative-free 0.5%~     timolol maleate.~   "
193801|NCT01026818|"~     The study will include patients with localized prostate cancer who experience erectile~     dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be~     randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on~     demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for~     9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for~     recovery of unassisted erectile function (without medication). An open-label extension for~     three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day.~     Further objectives are to evaluate the treatment satisfaction of the respective therapies.~   "
193802|NCT01026805|"~     This study assesses the effectiveness of intrauterine fibroid and polyp removal using the~     Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective~     review of medical records of women who have been treated with the device.~   "
193803|NCT01026792|"~     This phase II trial studies the effects of temsirolimus in treating patients with cervical~     cancer that cannot be cured by standard therapy. Temsirolimus interferes with a protein in~     cells that is part of one pathway that sends signals to stimulate cell growth and survival.~     By blocking this protein cancer cells may stop growing or die.~   "
193804|NCT01026779|"~     The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has~     had in the community both on the number of rotavirus-associated hospitalizations and on the~     strains of rotavirus circulating in the community. The investigators will use cases of~     rotavirus gastroenteritis identified on the wards at Hasbro Children's Hospital during the~     2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine~     effectiveness in preventing rotavirus-associated hospitalizations. The investigators plan to~     assess rotavirus vaccine coverage in Rhode Island using the state vaccine registry and to~     examine whether and to what extent rotavirus vaccine was used outside the recommended age~     limits (off label) during the first 2 years of its implementation in Rhode Island. Finally~     using the state child health database, KIDSNET the investigators plan to investigate the~     reasons that children may not have received rotavirus vaccine in order to better target~     educational efforts for parents and health care providers.~   "
193805|NCT01026766|"~     The aim of the present study was to evaluate if the combination of heat and moisture~     exchanger with air forced warming blankets or warming intravenous fluids prevents~     intraoperative hypothermia in obese and non obese women under target controlled~     infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal surgery.~   "
193806|NCT01026753|"~     The primary purpose of the study is to investigate the efficacy and effectiveness of a~     community-based nurse managed telephone support line (Provincial Health Contact Center; PHCC)~     and Colorectal Cancer Information and Screening Website in supporting Primary Care Providers~     (PCP) from Winnipeg, Manitoba (Canada) in their efforts to improve colorectal cancer (CRC)~     screening Fecal Occult Blood Test (FOBT) compliance in average risk men and women 50-74 years~     of age. Secondary outcomes of the study involve documenting and investigating common patient~     questions and comments about CRC and the FOBT during their PHCC communication(s)/Website~     visits as well as procuring feedback from PCP and patients related to their experiences with~     the study protocol (PCP), FOBT (patients) and PHCC/website (patients).~   "
193807|NCT01026740|"~     The primary objective of this study is to measure the penetration of ceftobiprole into~     subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration~     over time of ceftobiprole in these tissues and in plasma after administration of a single~     intravenous (i.v.) infusion (directly into the vein) of ceftobiprole 500 mg administered over~     2 hours. The secondary objective was to further assess the safety and tolerability of~     ceftobiprole after a single i.v. infusion.~   "
193808|NCT01026727|"~     This phase 2b study is designed to assess the long-term efficacy (24 weeks) of MPC-4326 in~     combination with a 2-3 drug optimized background regimen (OBR) relative to the efficacy of a~     3-4 antiretroviral (ARV) regimen in treatment experienced, HIV-1 infected subjects.~   "
193809|NCT01026714|"~     The cytochrome P450 enzymes (CYP) are the major drug-metabolizing enzyme system in humans. A~     great inter- individual variability affects the activity of these enzymes, and consequently~     the plasma drug concentrations resulting in different pharmacodynamic effects and occurrence~     of effect sides. Environmental factors, diet, drugs or genetics are responsible for this~     variability. Genetic factors are very important since the majority of these enzymes are~     highly polymorphic. For example, over 80 CYP2D6 allelic variants have been discovered so far~     and are associated to the absence, a decrease, or an increase in enzyme activity. Most~     polymorphisms were detected by adverse reactions occurring in a group within the population~     after normal doses of drugs had been administrated. Those patients experiencing adverse~     reactions often had a reduced capability to metabolize certain drugs. In clinical therapy,~     this variability has important consequences including the lack of response to a treatment~     and/or adverse drug reactions. In order to reduce these potentially unwanted events possibly~     leading to sever adverse reactions or death, it might therefore be of decisive interest to be~     able to assess the activity of these enzymes at the individual level. Two approaches may be~     used to assess CYPs activities, genotype and phenotype. Genotype is based on DNA analysis and~     polymorphism detection. Phenotype consists of administration of model drug or probe drug~     metabolized by a specific CYP and a determination of a ratio between the drug and its~     metabolite in plasma or urine. The principal drawback of the phenotyping methods is the urine~     collection overnight or at least 8 hours after the administration of probe test. This~     procedure is very tedious and time consuming for the patient as well as for the medical~     staff. The test can be performed in plasma or blood 1-2 hours after probe administration.~     However, this procedure is invasive and needs an important volume of blood (6 ml). Recently,~     a novel approach has been developed for the quantitative determination of circulating drug~     concentrations using dried blood spots (DBS) on filter paper obtained with a simple finger~     prick. Due to the small blood volume required (about 10 µL) compared to conventional~     sampling, this minimally invasive method provides a patient-friendly alternative for blood~     collection in patient population where venous sampling is unethical or impossible~     (pediatrics).~      In addition, DBS sampling does not require the use of anticoagulant, plasma separation and~     decreases contact with infectious material. Furthermore, dried blood spots can be easily~     stored and shipped to analytical laboratories without using refrigerated devices.~      Thanks to the new developments in analytical techniques (mass spectrometry), which permit~     quantitative analysis from very small volume of blood. DBS sampling represents a powerful~     tool for the biomedical analyses, particularly in pharmacokinetic studies where several blood~     samples are needed and for phenotyping procedures.~   "
193810|NCT01026701|"~     The purpose of this study is to measure the markers related to bone metabolism before and~     after the use of bortezomib injection in patients with multiple myeloma and to evaluate the~     effect bortezomib injection has on bone disease.~   "
193811|NCT01026688|"~     Diabetes is a common and serious chronic disease. However, there is a large gap between the~     level of care that people should receive (based on research and guidelines) and the level of~     care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the~     Canadian Diabetes Association has a strategy to improve heart disease screening and treatment~     for people with diabetes. This study will evaluate whether the strategy works. The focus of~     the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them~     delivery better care for their diabetic patients. In Ontario, only half of doctors received~     this Toolkit. We will compare the quality of care received by diabetic patients whose doctors~     received this Toolkit versus those who doctors did not.~   "
193816|NCT01026623|"~     This phase I/II trial is studying the side effects of giving cixutumumab together with~     temsirolimus and to see how well it works in treating patients with metastatic prostate~     cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab~     together with temsirolimus may kill more tumor cells.~   "
193817|NCT01026610|"~     The purpose of the study is to investigate the safety and the antiviral activity of two doses~     of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection~     compared to entecavir 0.5 mg.~   "
193818|NCT01026597|"~     This study will test the safety and tolerability (how the body reacts to the drug) of REGN727~     compared with placebo (an inactive substance that contains no medicine) in healthy subjects.~     The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic~     visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be~     monitored by the study staff for side effects and the body's response to the study drug.~     Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood~     and urine samples will be collected at some or all visits.~   "
193819|NCT01026584|"~     The aim of the study is to investigate the efficacy and safety of aripiprazole in patients~     with first episode psychosis.~   "
193820|NCT01026571|"~     BAVgenetics is a partnership between Investigators at Brigham and Women's Hospital,~     Massachusetts General Hospital and the Harvard-Partners Center for Genetics and Genomics,~     dedicated to discovering the genetic causes of bicuspid aortic valve disease and associated~     aortic disease.~   "
193821|NCT01026558|"~     The primary objective of this study is to compare the pharmacokinetics (how drugs are~     absorbed in the body, how they are distributed within the body and how they are removed from~     the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The~     secondary objectives are to assess the pharmacodynamics (the study of the action or effects a~     drug has on the body) and to assess safety and tolerability of ceftobiprole in order to~     support dosing recommendations in the morbidly obese population.~   "
193822|NCT01026545|"~     This study is a randomized, investigator blind, subject blind, sponsor-open, placebo~     controlled, multiple dose escalating, sequential, parallel cohort study of PF-04287881.~     Subjects will undergo screening procedures within 28 days prior to dosing. At least 1 day~     after the Screening visit, eligible subjects who meet the entry criteria will be admitted to~     the Clinical Research Unit (CRU) and confined in the unit until discharge on Day 15.~      Approximately 60 healthy volunteers (20 volunteers of Japanese origin for Cohorts 5 and 6),~     18 to 55 years of age, males and females (women of non childbearing potential only) will be~     enrolled and randomized in a 4:1 ratio to treatment with either PF-04287881 or placebo within~     each cohort. Each cohort will have a 10 day dosing period and each will consist of 10~     subjects (8 active and 2 placebo). In each cohort, each subject will receive a single daily~     oral dose of either placebo or PF-04287881 under fasted state for 10 days.~   "
193823|NCT01026532|"~     The purpose of this study is to determine how a special white blood cell, the eosinophil, can~     contribute to asthma. One of the characteristics of asthma is airway inflammation. Airway~     inflammation in asthma may occur when an allergen is inhaled and sets up an allergic reaction~     in the bronchial tubes. This reaction may lead to chest tightness, cough and wheeze. To~     better understand the way in which the eosinophil can cause inflammation, the investigators~     plan to study eosinophils that move in to the lung following an allergic reaction.~   "
193824|NCT01026519|"~     This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability~     and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis~     patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects~     each with active rheumatoid arthritis will be dosed SC.~   "
193825|NCT01026506|"~     The study was performed to investigate the effects of a dietary intervention with c9,t11-CLA~     on clinical and immunological parameters in children and adolescents with allergic bronchial~     asthma.~   "
193826|NCT01026493|"~     RATIONALE: Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as temozolomide. work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving veliparib together with temozolomide may kill more tumor cells.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     giving veliparib together with temozolomide and to see how well it works in treating patients~     with recurrent glioblastoma.~   "
193827|NCT01026480|"~     Little is known about the factors that predispose patients to complications after an ileal~     pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that~     prospectively captures pre- and post-surgical data from participants. Retrospective studies~     concerning IPAA outcomes and will be conducted using these data.~   "
193828|NCT01026467|"~     This phase II trial is studying how well a frailty index and geriatric assessment works in~     predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small~     cell lung cancer. A frailty index and geriatric assessment prior to treatment may help~     identify a better treatment regimen~   "
193829|NCT01026454|"~     The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or~     acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with~     HIV-1 and HSV-2.~   "
193830|NCT01026441|"~     This study is intended to test the safety of the Vela100 device when used for treatment for~     cellulite and circumference temporary reduction.~   "
193848|NCT01026207|"~     Introduction:~      The prevalence of overlap between Chronic Obstructive Pulmonary Disease (COPD) and~     Obstructive Sleep Apnea Syndrome (OSAS) is around 10%. This overlap syndrome is an important~     issue because is related to nocturnal desaturation and its complications. The use of portable~     monitoring devices (PM) for the diagnosis of OSAS was recently accepted as an alternative to~     full-night polysomnography (PSG). However, there are not studies evaluating the PM recording~     in COPD patients to detect or exclude OSAS.~      Objective:~      To evaluate if a PM (Stardust®, Respironics, Inc, USA) could accurately measure the~     apnea-hypopnea index (AHI) in COPD patients with a suspicion of OSAS.~   "
193831|NCT01026428|"~     The objective of this study is to investigate the effect of safinamide on levodopa blood~     levels, both after single and multiple dosing of safinamide . A further objective of the~     study is to assess the safety and tolerability of safinamide when given together with~     levodopa in the applied regimen.~      For that purpose, all study participants will undergo intensive blood sampling for~     investigation of levodopa levels and various tolerability examinations, such as the~     measurement of vital signs (blood pressure, pulse, body temperature), recording of ECGs and~     questioning to find out how the study participants are feeling. Furthermore, blood samples~     will be drawn and urine tests will be performed repeatedly for safety purpose during the~     course of the study.~      The results of this clinical trial may be used for the drug registration of safinamide in the~     future.~   "
193832|NCT01026415|"~     The purpose of this study is to identify brentuximab vedotin drug-drug interactions in~     patients with CD30-positive cancers and to determine the main route of excretion. The study~     will also assess blood drug levels in patients with renal or hepatic impairment (special~     populations).~   "
193833|NCT01026402|"~     The main purpose of the study is to establish a safe dose of the drug by providing~     information on any potential side effects this drug may cause and collecting data about how a~     patient's cancer responds to the drug. The study will also assess the blood levels and action~     of AZD2014 in the body over a period of time and will indicate whether the drug has an effect~     on the types of cancer the patients have.~   "
193834|NCT01026389|"~     This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography~     (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal~     or lower limb arterial diseases.~   "
193835|NCT01026376|"~     The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome~     (MDS) of all FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and~     High-Risk International Prognostic Scoring System groups, including both previously treated~     and untreated patients.~   "
193836|NCT01026363|"~     The human immune system produces a protein called hCAP18 (also known as LL-37 or~     cathelicidin). This protein is believed to help the body to fight infections. Studies suggest~     that vitamin D may important in the production of hCAP18. This study is designed to test the~     ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18~     levels will be measured during an initial visit. Individuals who are vitamin D deficient will~     be randomly assigned to receive one of two forms of vitamin D for two weeks. After this,~     follow-up levels will be measured.~   "
193837|NCT01026350|"~     Administration of colostrum enriched with anti-Flu antibodies may alter host's response to~     the flu virus.~   "
193838|NCT01026337|"~     Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response~     to treatment and help plan the best treatment.~      Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in~     patients with locally advanced or metastatic kidney cancer.~   "
193839|NCT01026324|"~     This is a phase I/II trial is studying the side effects and best dose of dinaciclib and to~     see how well it works in treating patients with advanced melanoma. Dinaciclib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
193840|NCT01026311|"~     The purpose of this study is to evaluate the effect of coenzyme Q10 administration in~     improving mitochondrial function as measured by anaerobic threshold in older athletes on a~     stable dose of statin medication.~   "
193841|NCT01026298|"~     Obstructive sleep apnea (OSA) is a common but under-diagnosed form of sleep disordered~     breathing (SDB). Asthma is a common disease with rising prevalence, which continues to pose~     significant morbidity and costs. In spite of considerable progress in our understanding of~     asthma, a large number of individuals with asthma continue to have symptoms and subsequently,~     have a poor functional status, poor quality of life and increased health care costs. In many~     cases no apparent cause is found and optimal therapy does not achieve its goal. While recent~     data suggests that OSA is common in severe asthma, the prevalence of OSA and its predisposing~     factors have not been studied.~   "
193842|NCT01026285|"~     International Observational Registry on Schizophrenia~   "
193843|NCT01026272|"~     The investigators hypothesize that the endogenous cannabinoid signalling system has lost~     homeostasis in the disease multiple sclerosis (MS). To investigate a novel action of dietary~     fish oils, the investigators will administer a food frequency questionnaire to both healthy~     subjects and patients with MS. The investigators will first determine if there are~     differences between both populations of endogenous cannabinoids, and then determine whether~     dietary intake of fish oils alters these levels~   "
193844|NCT01026259|"~     The purpose of this study is to determine if local warming of surgical wounds improves~     healing and helps prevent infection. The investigators want to see if warming surgical~     incisions improves oxygen levels and healing in skin close to the incision.~   "
193845|NCT01026246|"~     Malaria is caused by a germ that people get from the bites of some mosquitoes. It kills over~     2 million people each year. Many of the drugs used to treat malaria do not work as well as~     they used to and researchers are exploring other vaccines to prevent malaria. The purpose of~     this study is to learn if the vaccine, called EBA-175 RII-NG, is safe and if it strengthens~     the body's defenses against malaria. Participants will include 60 healthy adults, ages 18-40,~     recruited from Accra, Ghana. Several dosages of the vaccine will be tested for safety. The~     lowest dosages of the vaccine will be tested before the next higher dose is tested. There~     will be two groups for each dose, one group will receive the vaccine and the other group will~     receive a placebo (salt water solution). Participants may be involved in study related~     procedures for up to 398 days.~   "
193846|NCT01026233|"~     The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in~     patients with CD30-positive cancers. The study will assess electrical activity of the heart~     before and after brentuximab vedotin administration. Patients who have stable or improving~     disease may receive up to 1 year of brentuximab vedotin treatment.~   "
193847|NCT01026220|"~     This phase III trial is studying how well giving combination chemotherapy together with~     radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma.~     Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. Radiation therapy uses high energy~     x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy~     may kill more cancer cells.~   "
193851|NCT01026155|"~     Obese patients are known to have increased work of breathing inducing dyspnea, exercise~     intolerance and impaired quality of life. Respiratory muscle training is known to increase~     respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy~     subjects and respiratory patients. The investigators hypothesized that Respiratory muscle~     training would reduce dyspnoea, increase exercise tolerance and quality of life in obese~     patients.~   "
193852|NCT01026142|"~     This randomized, two-arm study evaluated the efficacy and safety of a combination of~     trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal~     growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population~     consisted of female patients, whose disease had progressed during or following previous~     trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received~     trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and~     capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and~     1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg~     iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued~     until disease progression or unacceptable toxicity.~   "
193853|NCT01026129|"~     This study is designed to compare the effects of a bolus dose of remifentanil to a bolus dose~     of lidocaine given prior to the emergence of anesthesia:~        -  on the incidence of perioperative coughing~        -  on the time needed for the emergence of a desflurane-based anesthesia~        -  on the incidence of sore throat after extubation.~      Our hypothesis is that the use of a remifentanil bolus dose given prior to emergence of a~     desflurane-based anesthesia will reduce the incidence of perioperative coughing from 70% to~     35% compared to lidocaine.~   "
193854|NCT01026116|"~     Manifold data revealed that young breast cancer patients are characterized by aggressive~     clinical history. The purpose of this study is to evaluate the efficacy and safety of~     different strategies incorporating paclitaxel to anthracycline-based regimens in young breast~     cancer patients.~   "
193855|NCT01026103|"~     The objectives of this clinical trial are to assess in a pilot setting the overall~     performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™~     Technology when used in a gastric bypass procedure.~   "
193856|NCT01026090|"~     Primary Objective:~      To determine whether daily administration of dronedarone started 5-7 days before~     cardioversion is superior to dronedarone started only after cardioversion with respect to the~     absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in~     adult patients with persistent AF, for whom cardioversion is clinically indicated and planned~     to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of~     cardiovascular hospitalization due to AF.~      Secondary Objectives:~      Main Secondary :~        -  To assess the number of symptomatic AF recurrences/patient/6 months with and without ECG~          confirmation;~        -  To assess characteristics of symptomatic AF recurrence in the two treatment arms~          (frequency, duration of episodes, type, number, and severity of AF symptoms per~          patient);~        -  To compare the rates of early recurrences of AF between the two treatment strategies;~      Other secondary:~        -  To assess whether there is a difference in proportion of patients with symptomatic AF~          recurrences (with and without ECG confirmation) between the two treatment strategies;~        -  To assess whether there is a difference in number of electrical cardioversions per~          patient between the two treatment strategies;~        -  To assess the impact of the two strategies on number of shocks, cumulative amount of~          energy delivered, shock failure, and immediate success of cardioversion;~        -  To assess whether there is a difference in rate of cardiovascular (CV) hospitalizations~          and length of hospital stay between the two treatment strategies;~        -  To assess whether there is a difference in quality of life between the two treatment~          strategies.~   "
193857|NCT01026077|"~     The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies exposed~     to Savella (milnacipran HCI). This is an observational, exposure-registration and follow-up~     registry designed primarily to estimate the prevalence of major congenital anomalies, and~     secondarily to estimate the prevalence of recognized spontaneous abortions, stillbirths,~     induced abortions, minor congenital anomalies, and any serious adverse pregnancy outcomes~     among pregnancies exposed to Savella as well as adverse outcomes observed during the first~     year of life in off-springs born from these exposed pregnancies. Live offspring are followed~     from birth until age one. The Savella Pregnancy Registry is sponsored by Allergan (formerly~     Actavis PLC and Forest Laboratories Inc.) and managed by INC Research, LLC.~   "
193858|NCT01026064|"~     The purpose of this study is to investigate the utility of the cantharidin-induced skin~     blister assay for evaluation of the anti-inflammatory effects of macrolides in healthy male~     volunteers.~   "
193859|NCT01026051|"~     The clinical trial is evaluating a multi-component active immunotherapy designed to stimulate~     an immune reaction to specific tumor associated antigens which are highly expressed on~     melanoma~   "
193860|NCT01026038|"~     This is an open-label study (a study in which the doctors and participants know which drug or~     vaccine is being administered) in children who previously received a 4-dose series of a~     pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In~     this study, participants will receive an additional dose of 13-valent pneumococcal conjugate~     vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody~     response by measuring any remaining pneumococcal antibodies since the previous study. This~     study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate~     vaccine when administered at least 24 months after the last dose of pneumococcal conjugate~     vaccine.~   "
193861|NCT01026025|"~     The objectives of this clinical trial are to estimate the incidence and duration of air leaks~     and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic~     Surgery) when using the ENDO GIA Staplers with ENDO GIA Single Use Loading Units (SULUs)~     buttressed with Duet TRS TM in an anatomic pulmonary resection via Video Assisted~     Thoracoscopic Surgery (VATS). Anatomic pulmonary resection is defined as either a lobectomy~     or segmental resection. Results of the study will be compared to contemporary literature for~     a similar population.~   "
194057|NCT01023477|"~     The purpose of this study is to test the hypothesis that chloroquine will reduce the ability~     of ductal carcinoma in situ (DCIS) to survive and spread. Participants will receive either~     chloroquine standard dose (500mg/week) or chloroquine low dose (250mg/week) for 1 month prior~     to surgical removal of the tumor.~   "
193862|NCT01026012|"~     It is been known for at least 20 years that the hemodynamic data, the amount of exercise~     performed as well as symptoms on the treadmill, has significant value to the perfusion stress~     testing. When a pharmacologic stress test is performed (and adenosine stress test over 4-6~     minutes), this hemodynamic data is lost. Because of this loss of valuable data, it is felt~     that there is also a loss of significant prognostic data as well. With the advent and FDA~     release of Regadenoson in a rapid injection form (over 10 seconds), it is thought that the~     combination of both exercise stress testing and pharmacologic testing in subjects that do not~     achieve 85% in a maximal predicted heart rate may be a viable stress testing option.~      The purpose of this study is to look at using the drug, regadenoson, with exercise stress~     testing; and the side effect symptoms that may be experienced by individual subjects using~     this combination.~   "
193863|NCT01025999|"~     This study is designed as a prospective clinical trial aimed at investigating the mechanisms~     behind observed improvements in type 2 diabetes mellitus (T2DM) following bariatric surgery.~     The majority of patients with T2DM who are undergoing Roux-en-Y gastric bypass (RYGB)~     surgery, in particular, experience complete remission of T2DM almost immediately~     post-surgery. This response occurs before significant weight loss is possible. To assess the~     mechanisms involved with disease resolution, the investigators propose a study to evaluate~     patients at the UW Medical Center (UWMC) who have T2DM and are undergoing RYGB with G~     (gastronomy)-tube placement as part of their clinical care. The investigators are interested~     in this sub-population as the G-tube allows us the unique opportunity to evaluate glycemic~     control and insulin response following delivery or exclusion of nutrients to the otherwise~     bypassed portion of the gastrointestinal tract. The investigators hypothesize that nutrient~     delivery to the proximal GI tract will reverse RYGB-mediated improvements in glucose~     homeostasis, possibly in association with changes in nutrient-regulated gut peptides involved~     in glucose control.~   "
193864|NCT01025986|"~     The purpose of this study is to conduct a prospective analysis to determine the relationship~     between disease activity of noninfectious uveitis and stress.~   "
193865|NCT01025973|"~     The investigators will perform biochemical and metabolic evaluations on cord blood, venous~     blood of the mother and urine of the foetus and mother using time-of-flight and tandem mass~     spectrometry. The investigators could evaluate, dose and validate gestational diabetes~     mellitus biomarkers of the fetus and mother.~   "
193866|NCT01025960|"~     Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer~     deaths in western countries. Colonoscopy is a preferred colorectal screening modality since~     it has both diagnostic and therapeutic capability. Detection and removal of polyps at~     colonoscopy decreases the incidence and mortality from colorectal cancer.~      Typical practice is to insert the colonoscope rapidly until it reaches the cecum (a~     pouch-like portion of the intestines, where the large bowel and the small bowel meet). The~     physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities~     within the large bowel. The purpose of this study is to compare this standard practice to the~     approach whereby the physician examines the bowel as the scope is initially inserted AND as~     the colonoscope is withdrawn from patients' colons.~   "
193867|NCT01025947|"~     STUDY TYPE:~      Prospective, national , multicenter, and observational study.~      OBJECTIVE:~      To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF~     detection device during a period of 2 years.~      DEVICE:~      Reveal XT 9529 (SQDM)~      SAMPLE SIZE AND STUDY DURATION:~      100 patients enrolled which will be followed during a period of 2 years.~   "
193868|NCT01025934|"~     The purpose of this study is to evaluate the role, the safety and the effectiveness of~     Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe~     proliferative diabetic retinopathy.~   "
193869|NCT01025921|"~     We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of~     tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The~     investigators hypothesize that this could be possible by decreasing the population of gram~     negative germs that colonize the lumen of tracheal tube and upper airways.~   "
193870|NCT01025908|"~     The objective of this study in cognitive-behavioural therapy (CBT) was to demonstrate the~     preparation of the patient with panic disorder for agoraphobic exposures. The focus of the~     work consisted of interoceptive exposures, in vivo, of body sensations themselves, to feared~     places and situations. The sample consisted of 50 individuals. Group 1 undertook 10 weekly,~     individual sessions of CBT of one hour duration. Group 2, control, was just follow-up with~     supportive therapy. The procedures used for the exposures, especially for induction symptom~     exercises, were considered essential in the preparation of patients with panic disorder, to~     be able to face up to panic attacks and subsequent agoraphobic situations.~   "
193871|NCT01025895|"~     ACL tear is a common injury among athletes. The recommended treatment includes reconstruction~     of the ligament. The common reconstruction technique is single bundle reconstruction.~     However, this technique does not simulate the natural structure of the ligament. The purpose~     of the study is to compare between the common procedure, Single Bundle reconstruction with~     the Double Bundle reconstruction technique.~   "
193872|NCT01025882|"~     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving stereotactic body radiation therapy~     together with gemcitabine hydrochloride may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of stereotactic body radiation~     therapy when given with or without gemcitabine hydrochloride in treating patients with~     pancreatic cancer that can be removed by surgery.~   "
193873|NCT01025869|"~     To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the~     treatment of de novo lesions in native coronary arteries.~   "
193874|NCT01025856|"~     The aim of this study will be to evaluate in patients with type 2 diabetes the effects on~     liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a~     diet rich in MUFA, either combined or not with a structured program of physical exercise,~     with emphasis on mechanisms possibly underlining these effects, namely changes in~     postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity,~     oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and~     endothelial function.~   "
193875|NCT01025843|"~     This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety,~     tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males.~     Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in~     participants with hypertension. The primary hypothesis is that single oral doses of MK-5478~     are sufficiently safe and well tolerated.~   "
193876|NCT01025830|"~     The null hypothesis is that there is a difference in the the relative rate and extent of~     absorption into the systemic circulation of Triomune and brand-name~     Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is~     that there is no difference in the the relative rate and extent of absorption into the~     systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in~     HIV-infected Africans. This is a non-inferiority study.~   "
193877|NCT01025817|"~     The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with~     low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney~     transplant recipients.~   "
193878|NCT01025804|"~     Asparaginase is an important drug in the treatment of childhood leukemia including in infant~     (<1 year). The prognosis for infants is bad.~      Information about drug metabolism in neonates and infants is scarce as well as the reactions~     of an immature immune system to foreign proteins. The aims of this study is to describe the~     metabolism (pharmacokinetics) of asparaginase after administration intramuscularly and to~     evaluate the formation of antibodies against the drug (enzyme) during treatment in order to~     optimize the asparaginase treatment in infants in the future.~   "
193879|NCT01025791|"~     A three panel study, to determine if MK8266 given as a single dose is sufficiently safe and~     well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of~     subjects with mild to moderate hypertension.~   "
193880|NCT01025778|"~     Despite substantial progress in the treatment pediatric acute leukemia a significant number~     of children will experience primary or secondary resistance to the treatment. In other words~     it will be not possible to achieve remission using standard chemotherapy (primary resistance)~     or the patients will develop chemotherapy resistant relapse (secondary resistance). Children~     failing to achieve remission or children relapsing after previous allogeneic stem cell~     transplantation have short life expectancy and palliative treatment still remains the most~     reasonable option as the escalation of conventional chemotherapy is not longer effective.~      The role of Graft versus Leukemia effect was postulated as one of the mechanisms contributing~     to the leukemia control/eradication after transplantation of hematopoietic stem cells.~      In this study the investigators combine intensified multiagent Clofarabine containing~     chemotherapy with post-induction treatment intensification using reduced intensity~     conditioning followed by haploidentical hematopoietic stem cell transplantation. Introducing~     a new drug to the treatment of resistant leukemia the investigators want to achieve a~     response which allows us to proceed to immediate haploidentical transplantation. Using a~     haploidentical donor the investigators can avoid time consuming search for an unrelated donor~     and perform the transplantation at the optimal time-point. Combating therapy resistant~     leukemia the investigators would like to evoke and utilize potential Graft-versus-Leukemia~     effect which is much more pronounced in the haploidentical setting, as it is well documented~     that allogeneic transplantation with a matched donor is not effective in resistant disease.~     The use of best KIR mismatch donor and post-transplant donor lymphocyte infusion will be~     implemented in order to develop/intensify graft versus leukemia effect.~   "
193881|NCT01025765|"~     Pegylated interferon in combination with ribavirin is the current standard treatment of~     chronic hepatitis C virus infection, but is expensive and has several adverse effects. To~     modify this standard treatment by optimizing its therapeutic effect and decreasing its~     adverse events are important. Recent studies have identified a close link between metabolic~     profiles, insulin resistance and Hepatitis C Virus (HCV) infection. Several pilot studies in~     western world have have found beneficial effects of oral hypoglycemic agents on chronic~     Hepatitis C (CHC) genotype 1 infected patients. Whether this concept still holds true in~     Taiwanese people remains unknown.~      The objective of this clinical trial is to evaluate the effect of oral hypoglycemic agents~     (daily for 4 weeks of run-in period and 8 weeks of combination treatment) on CHC genotype 1~     infected Taiwanese patients receiving 48 weeks of Peg-IFN plus ribavirin (RBA), and the~     enrolled subjects will be randomized into 4 treatment groups (including Acarbose, Metformin,~     Pioglitazone and standard care control groups). During the trial and 24 weeks after the end~     of treatment, serial serum HCV RNA, alanine aminotransferase (ALT) levels, and other clinical~     data will be evaluated to determine the therapeutic response and adverse events of the CHC~     patients.~   "
193882|NCT01025752|"~     The proposed study will test how well an innovative method, interactive voice response (IVR),~     can be used for delivering an treatment for chronic low back pain. The use of IVR will~     improve the accessibility of treatment to Veterans. IVR is a computerized interface that~     allows patients to use their telephone to: 1) obtain pre-recorded didactic information, 2)~     report data regarding pain-related symptoms and adherence to pain coping skill practice, and~     3) receive personalized therapist feedback. Although CBT has been shown to be effective in~     reducing pain intensity, traditional CBT requires patients to make frequent office visits.~     The use of IVR will allow Veterans to access CBT from their home via a touch-tone telephone,~     thereby allowing them to access treatment at their convenience without travel to the VA for~     an outpatient appointment. Veterans with chronic low back pain will be randomized in equal~     numbers to receive either standard CBT or IVR-based CBT. Veterans in both conditions will~     receive 10 session of treatment designed to help them manage their chronic pain using pain~     coping skills. The primary outcome measure will be pain intensity.~   "
193883|NCT01025739|"~     Objectives of the Study:~      The primary objective of this study is to evaluate the relative merits, safety and~     effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent~     GERD symptoms despite PPI therapy.~      The secondary objective of the study is to evaluate the effectiveness of the tailored TIF~     procedure in restoring the antireflux barrier and eliminating GE reflux.~      Type of Study:~      Prospective, non-randomized, uncontrolled Study Duration 12 months Number of Patients 20~      Inclusion Criteria:~      Age 18-70 years, on daily PPIs for > 6 months, persistent GERD symptoms despite PPI therapy,~     anatomic disruption of the gastroesophageal valve to a Hill Grade II-III, evidence of one of~     the following while on PPI therapy: (1) erosive esophagitis (erosions or ulcerations during~     endoscopy); (2) abnormal ambulatory pH study; or (3) biopsy confirmed changes characteristic~     of reflux esophagitis; acceptable esophageal motility (by either manometry or video~     esophagogram), hiatal hernia no larger than 2 cm, patient willing to cooperate with~     post-operative dietary recommendations and assessment tests, signed informed consent~      Exclusion Criteria:~      BMI > 40, hiatal hernia > 2 cm, esophagitis grade D, esophageal ulcer, fixed esophageal~     stricture, gastric motility disorders, previous splenectomy, pregnancy (female),~     immunosuppression, ASA > 2, portal hypertension and/or varices, history of previous resective~     gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal~     epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis,~     or cirrhosis, active gastro-duodenal ulcer disease, gastric outlet obstruction or stenosis,~     gastroparesis or delayed gastric emptying, coagulation disorders~      Interventions:~      Treatment: Tailored transoral incisionless fundoplication (TIF2) using EsophyX system with~     SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA)~      Evaluation Criteria:~      Primary Outcome Measure 24 hour pH impedance study: change in Johnson DeMeester scores;~     GERD-HRQOL scores Secondary Outcome Measures PPI usage, GERD symptoms at 6 and 12 months vs.~     baseline off PPI's, total number of reflux episodes, and Symptom Association Probability~     while off PPI.~      Safety: Adverse events will be mapped to standard terms and reported.~   "
193884|NCT01025726|"~     Regular moderate and vigorous intensity physical activity (PA) is inversely related with~     obesity, however, few adults are successful in incorporating sufficient PA into their daily~     lives. Minority and lower-income adults have among the highest obesity rates and lowest~     levels of regular PA. Increasing environmental supports for safe and convenient places for PA~     is an emerging public health strategy for PA interventions. Preliminary data by Wilson (PI)~     and colleagues has revealed through focus groups that low-income minority adults would like~     to increase the safe places for PA (areas free from crime, containment of stray dogs,~     increased police patrol) and access to PA (sidewalks/trails and expand opportunities for PA)~     in their community. In addition, the results of the investigators' preliminary studies~     suggest that African Americans had psychosocial barriers to PA that included lack of~     self-motivation, cultural body image issues, and lack of time due to family obligations. The~     present proposal is innovative in that it specifically tests the efficacy of an intervention~     that includes both patrolled-walking and social marketing elements to increase PA in~     low-income African Americans. Three communities will be randomized to receive one of three~     programs: a police patrolled-walking program plus social marketing intervention, a police~     patrolled-walking only intervention, or no walking intervention (general health education~     only; N=390; 130/group). The 24-month intervention will focus on increasing safety (training~     community leaders to serve as walking captains, hiring off-duty police officers to patrol the~     walking program, and containing stray dogs), increasing access for PA (marking a walking~     route), and will include a tailored social marketing campaign for increasing PA (in one~     intervention community). The investigators will collect data for PA (7-day accelerometer~     estimates, 4-week PA history), body composition, blood pressure, psychosocial measures, and~     perceptions of environmental supports for safety and access for PA at baseline, 6-,12-,18-,~     and 24-months. The primary hypotheses are that the patrolled-walking plus social marketing~     intervention will result in greater increases in moderate and vigorous PA as compared to a~     patrolled walking only intervention or no-intervention by 12-months and that these effects~     will be maintained at 18-month and 24-month assessments.~   "
193885|NCT01025713|"~     The purpose of this study is to evaluate the safety and tolerability of GS-9411 in patients~     with Cystic Fibrosis. GS-9411 is a sodium channel inhibitor, that may restore airway~     hydration and mucociliary clearance in the lung.~   "
193886|NCT01025700|"~     Safety of Nabilone in reducing marijuana craving~   "
193887|NCT01025687|"~     The investigators hypothesize that television viewing will affect food intake in adolescent~     girls, and will depend on pubertal stage. Food intake will be measured at 30 min following a~     glucose(1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the~     presence of TV. Subjective appetite will be measured as well.~   "
193888|NCT01025674|"~     This project focuses on social and character development of elementary and middle school-aged~     children and responds to an urgent national need that schools improve their capacity to~     address a range of student outcomes, including social skills, character, behavior, academic~     achievement and health outcomes. This study is a school-based randomized trial to evaluate~     the Positive Action program. The Positive Action program was designed to promote social and~     character development and improve behavior and school performance.~   "
193889|NCT01025661|"~     The purpose of the study is to explore the short term effects of chiropractic care on pain~     and function in patients with hip osteoarthritis.~   "
193890|NCT01025648|"~     The main objective of this study is to evaluate the efficacy and safety of the Armstrong's~     Epinephrine HFA-MDI (E004) formulation, in comparison to the Placebo (Placebo-HFA) and an~     Active Control (Epinephrine CFC-MDI), and to identify the optimum E004 dose strength(s) for~     the ensuing pivotal clinical trials. The study will be conducted in adult patients who have~     intermittent, or mild-to-moderate persistent, asthma, but are otherwise healthy.~      The bronchodilatory efficacy of E004, is evaluated in terms of post-dose area under the~     curves (AUC) of FEV1 changes (% and volumes), from the pre-dose baseline values, in~     comparison to the Placebo Control and the Active Control.~   "
193891|NCT01025635|"~     This study will investigate the safety and efficacy of a new formulation of an existing~     medication for the treatment of papulopustular rosacea. The study will test the active~     ingredient plus foam against foam alone.~   "
193892|NCT01025622|"~     OBJECTIVE(S): Primary:~      To assess the safety of the intrahepatic reinfusion of increasing numbers of autologous~     highly purified CD133+ stem cells (SCs) to patients with end-stage liver disease. Safety will~     be evaluated as the incidence of adverse event (graded according to WHO) and clinically~     significant abnormal laboratory value following reinfusion of SCs.~      Secondary:~      To assess the feasibility of the immunomagnetic selection of autologous CD133+ cells~     collected with leukapheresis from the peripheral blood (PB) of patients with end-stage liver~     disease, previously mobilized with G-CSF. To assess the effects of the intrahepatic~     reinfusion of highly purified CD133+ cells on residual hepatic function of the patients.~      STUDY DESIGN:~      Twelve patients will be enrolled. At first, G-CSF at 7.5µg/Kg/b.i.d. will be administered~     subcutaneously (sc) from day 1 until the completion of peripheral blood stem cells (PBSC)~     collection. Harvest of bone marrow (BM)-derived PBSC will begin on day + 4 only if the~     concentration of CD133+ cells is > 8/uL and will be continued until the collection of the~     target cell dose: 0.5 x 106 CD133+ cells/Kg for the first 2 cohorts of patients; 1 x 106~     CD133+ cells/Kg for cohort 3 and 2 x 106 CD133+ cells/Kg for cohort 4 (see below for~     definitions). PB mononuclear cells obtained from mobilized standard-volume leukapheresis will~     be incubated with Macs colloidal superparamagnetic CD133 microbeads and CliniMacs device will~     be used for the positive selection of CD133+ cells under good manufacturing practice (GMP)~     conditions. Cryopreservation and storage in liquid nitrogen will be performed according to~     standard procedures. At least 4 weeks after SC mobilization and collection, up to 40 mL of~     single cell suspension of highly purified autologous CD133+ cells, obtained after rapid~     thawing, will be infused through the hepatic artery by transfemoral or transbrachial~     arteriography. Infusion time will be lower than 15ml/min to avoid thrombi formation. The~     entire procedure will be performed under anesthesiological control. According to modified~     Fibonacci's increment rule, highly purified G-CSF-mobilized CD133+ cells will be administered~     to patients starting from 5x104/Kg patient's body weight and increased every 3 patients. The~     maximum infused cell dose will be 1x106/kg. G-CSF at 5µg/Kg/day will be administered sc for 3~     days after the reinfusion of SCs (day 0 to day +2).~   "
193893|NCT01025609|"~     This study will look at dietary patterns in individuals with chronic spinal cord injuries and~     the relationship between these dietary patterns and cardiovascular disease risk factors. The~     study is a supplement to the Coronary Artery Risk Development in Young Adults (CARDIA) study.~     The dietary history from CARDIA will be used. The investigators' primary hypothesis is the~     following: Greater whole-grain and dietary fiber intake will be favorably associated with~     adiposity (BMI and WC) and metabolic CVD risk factors (fasting glucose, fasting insulin,~     HOMA-IR, diabetes, hsCRP, TC, HDL-C, triglycerides, TC/HDL-C ratio, non-HDL-C, and systolic~     and diastolic blood-pressure) among a sample of individuals with SCI aged 38-50 who have been~     injured >1 year.~   "
193894|NCT01025596|"~     This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV~     infection resistant after 12 weeks of bi-therapy.~   "
193895|NCT01025583|"~     Hypotonic oral rehydration solutions (ORS) containing zinc and/or prebiotics have been~     proposed for the treatment of pediatric acute diarrhea but conclusive clinical data about~     their effect are scanty, especially for children living in developed countries. The~     investigators aim to evaluate the efficacy of a new hypotonic ORS containing zinc and~     prebiotics in children with acute diarrhea.~   "
193896|NCT01025570|"~     The purpose of this study is to find out the effects, good and/or bad, of the combination of~     two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether~     this combination can prevent pancreatic cancer from coming back.~   "
194058|NCT01023464|"~     To evaluate the effects of FID 114657 on tear film break-up time in dry eye patients.~   "
193897|NCT01025557|"~     The purpose of this protocol is to study the effects of fluid milk products on satiety, food~     intake, and glucose metabolism in healthy young men and women. Experiment 1: The specific~     objective is to investigate isovolumetric amounts of milk (2% M.F.), chocolate milk (1%~     M.F.), a soy beverage, cow's milk-based infant formula, and water (control) on satiety and~     food intake and on blood glucose before and after a meal. A fixed volume approach is based on~     the commercially available serving size. Experiment 2 will examine equicaloric amounts of~     milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, a~     glucose drink and water (control) the treatments in order to investigate macronutrient~     composition on satiety and food intake and on blood glucose before and after the meal.~   "
193898|NCT01025544|"~     This study will evaluate the safety and immunogenicity of booster doses of the two vaccines~     used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.~   "
193899|NCT01025531|"~     Subjects who eventually undergo treatment for HCV, we will gather treatment data (start and~     stop dates), and repeat CB-CAP analysis at weeks 4, 12, 24 and 72 (+/- 2 week window allowed~     at each time point) to determine whether CB-CAPs levels predict virologic response in treated~     subjects. Routine laboratory data will also be collected at these time points.~   "
193900|NCT01025518|"~     The purpose of this study is to investigate whether resistance training in combination with~     dietary supplementation is tolerable among head and neck cancer patients and to evaluate the~     possible effect on muscle mass, strength and functional capacity.~   "
193901|NCT01025505|"~     This study is an open-label, multicentric, exploratory, single arm, phase II study of adults~     who are either more than 60 years old, or are unfit for intensive chemotherapy and allo SCT.~     The patients are treated with NILOTINIB, administered orally twice daily, for 6 weeks (Course~     A) followed by IMATINIB, administered orally twice daily, for other 6 weeks (Course B).The~     courses will be repeated (rotated) for a total of 4 times or until relapse, or until it is in~     the interest of the patients. Prednisone (P) will be administered to all patients for 7-14~     days, before TKIs, so as to make it possible to wait for the results of cytogenetic and~     molecular tests, and to evaluate the response to P alone, hence for another 21 days.~     Intrathecal therapy (IT) with MTX/AraC/DEX is mandatory, monthly, in patients without~     clinical-cytologic evidence of meningeal involvement, while in patients with CNS involvement~     it is performed twice weekly until clearance of leukemic cells, hence once weekly. IM will be~     administered at the dosage of 600 mg daily (300 mg twice daily) and Nilotinib at the dosage~     of 800 mg daily (400 mg twice daily) in all courses.~      All patients are scheduled to receive at least 4 courses of either drugs, for a total of 4~     courses (4 x 6 = 24 weeks). After 4 courses, patients are either allowed to continue the~     treatment until relapse or progression, if it is in their interest, or to discontinue the~     treatment and receive other therapies.~   "
193902|NCT01025492|"~     Fibrates reduce atherosclerosis and cardiovascular disease events. A major mechanism of this~     benefit appears to be their ability to raise plasma high density lipoprotein cholesterol~     (HDL-C), especially in patients with high triglyceride levels. This study will investigate~     the effects of the addition of Trilipix (fenofibric acid) versus placebo to ongoing statin~     treatment on high density lipoprotein (HDL) composition and arterial function in subjects~     with insulin resistance.~   "
193903|NCT01025479|"~     Prevalence rate of osteoporosis and it's actual management condition in Prostate cancer~     patients who takes LHRH antagonist and anti androgen~   "
193904|NCT01025466|"~     The primary objective is to compare the tolerability between rivastigmine patch monotherapy~     and combination therapy with memantine in patients with Alzheimer's disease (AD). The~     secondary objective is to compare the efficacy and safety between rivastigmine patch~     monotherapy and combination therapy with memantine in patients with AD. The study hypothesis~     is that the tolerability of the combination therapy with memantine is not inferior to that of~     rivastigmine patch monotherapy in AD patients.~   "
193905|NCT01025453|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the~     National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid~     cancer.~      Temsirolimus is an intravenous medication that is FDA approved for other type of cancers. In~     laboratory studies, the addition of temsirolimus to sorafenib works better than sorafenib~     alone.~   "
193906|NCT01025440|"~     Phase One:~      High Flow (HF) CPAP (HF-CPAP) Titration:~      Participants will attend the sleep lab to undergo a comprehensive split-night respiratory~     PSG. Each participant will be randomized to one of 20 L/min or 35 L/min of CPAP for the first~     half of the night and swapped to the alternate flow rate for the second half o the night.~      At the completion of night 3 participants will be categorized as responders or~     non-responders. Only responders will continue to Phase 2 of the investigation.~      Phase Two:~      HF-CPAP compared with CPAP:~      Participants will attend the sleep lab to undergo a comprehensive overnight respiratory PSG.~     Each participant will be randomized to HF-CPAP at a flow rate of 35 L/min or to conventional~     CPAP at their therapeutic pressure. They will spend the entire night on this treatment arm.~     Thew following night participants will undergo the alternative treatment arm for the duration~     of the night.~   "
193930|NCT01025128|"~     Because of its high sun exposure, Israel was traditionally supposed to be protected from~     vitamin D deficiency, and the country food products hardly contain vitamin D supplements.~     However the Jerusalem ultra-Orthodox population, which constitutes a significant fraction of~     the city population, is at risk of developing vitamin D deficiency due to low sun exposure,~     as consequence of its dressing code covering most of the body and very limited time of~     outside activities. The investigators aim is to check whether vitamin D deficiency is found~     more frequently in the ultra-Orthodox male population in comparison to a non-ultra-Orthodox~     male population, and to study its eventual consequences. Correlation between vitamin D levels~     and PTH levels will be examined, according to age and to creatinine levels. Bone mineral~     density (BMD) will be evaluated in 2 selected subgroups of subjects (with lowest and highest~     vitamin D levels), and re-evaluated after 6 months of vitamin D supplementation in vitamin~     D-deficient subjects. An increase in BMD within 6 months would suggest osteomalacia as the~     main cause of low BMD in these subjects.~   "
193931|NCT01025115|"~     The purpose of this study is to assess the efficacy of Diamel administration in the treatment~     of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical~     trial will be 12 months.~   "
193907|NCT01025427|"~     Although highly active antiretroviral therapy (HAART) decreases HIV-associated mortality, it~     does not to completely restore health. Patients doing well on otherwise effective HAART~     remain at risk for cancer, cardiovascular/liver disease, osteopenia, and other~     non-AIDS-defining events. While complete eradication may never be feasible, a functional~     cure in which patients are able to maintain undetectable viral loads indefinitely without~     therapy may be possible. The best evidence for this are the so-called elite controllers,~     whom we define as individuals who are HIV-seropositive, with plasma HIV RNA levels below the~     level of conventional detection without treatment. Controllers may be conceptualized as a~     naturally occurring model of a functional cure (or HIV remission), and are ideal patients~     in which to study HIV persistence and the possibility of eradication.~      We propose to conduct a pilot study to better characterize the reservoirs that lead to viral~     persistence in a group of well-characterized controllers. We propose two specific aims: 1) to~     characterize the dynamics of viral production in blood and gut-associated lymphoid tissue~     (GALT) in controllers; and 2) to prospectively treat 10 controllers with raltegravir,~     tenofovir/emtricitabine for 24 weeks and study the effects of HAART on viral dynamics and~     host inflammatory responses.~      Our primary hypotheses are: 1) viral replication is ongoing in untreated controllers, 2)~     HAART will reduce viral replication in blood and GALT and decrease immune activation, and 3)~     higher levels of immune activation are associated with greater measures of microbial~     translocation and distribution of virus to more differentiated T cell subsets.~   "
193908|NCT01025414|"~     The primary objective of this study is to evaluate the effectives of enteral nutrition in the~     treatment of pancreatic fistulas. The ratio of pancreatic fistula closure after 30 days is~     selected as the primary outcome measure with the null hypothesis assuming that enteral~     nutrition provides better results than parenteral nutrition as far as the closure ratio, time~     to closure and treatment-related complications are concerned.~   "
193909|NCT01025401|"~     CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative~     three-dimensional analysis of movements.~      This is done to obtain a 3-D motor signature of seizures, for a given patient, and allows~     their detection with an ambulatory monitoring system.~      The benefit for patients is to improve the diagnosis of their diseases by better~     characterizing their seizures.~   "
193910|NCT01025388|"~     The purpose of the study is to establish the proportion of patients on lipid-lowering~     pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004~     NCEP ATP III guidelines, overall and by country, in the following sub-populations:~        -  Primary/secondary prevention patients.~        -  Patients with metabolic syndrome (according to NCEP III definition).~      In addition, the purpose is to establish the proportion of patients on lipid-lowering~     pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task~     Force guidelines/national guidelines, in the survey population and in the following~     sub-populations:~        -  Primary/secondary prevention patients.~        -  Patients with metabolic syndrome.~   "
193911|NCT01025375|"~     To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.~   "
193912|NCT01025362|"~     The Norwegian Action Plan on Nutrition aim at increasing the prevalence of breastfeeding. The~     initiative Baby-Friendly Community Health Services (BFCHS) is an initiative to reach this~     goal. BFCHS is developed from the concept The Baby-Friendly Hospital Initiative by~     WHO/UNICEF, and the intention is to increase the quality of breastfeeding counseling at~     Norwegian well-baby clinics.~      The purpose of the study~      The study seeks to answer the following research questions:~        -  What effect does the process of being certified as a BFCHS have on the proportion of~          mothers who exclusively breastfeed their children for 5 months?~        -  What effect does the process of being certified as a BFCHS have on the proportion of~          mothers who exclusively breastfeed for 4 months?~        -  What effect does the certification process have on the proportion of mothers who~          breastfeed at 11 months of age?~        -  What effect does the certification process have on the differences in breastfeeding due~          to social inequality?~        -  What effect does the certification process have on the mothers impression of the quality~          of the well-baby clinics lactation counseling?~        -  What effect does the certification process have on mothers satisfaction with the~          breastfeeding experience?~        -  What effect does the certification process have on perceived pressure to breastfeed?~          Methods Cluster randomized controlled study Sampling The survey unit, cluster, will be~          the community health services. All community health services in six counties in Norway~          will be invited to participate.~      Inclusion criteria: Norwegian speaking mothers who have 5 month and 11 month old children.~      Data collection Respondents are identified through the National Population Register (DSF).~     The data collection takes place using a postal questionnaire.~      Baseline: Data collection before the intervention is implemented to assess breastfeeding~     prevalence and distribution of covariates in the two study arms.~      Post-survey: The post-survey to assess the effect, will take place about two years after~     baseline when the community health services have been certified.~      Sample size It is expected that the project could increase the breastfeeding prevalence with~     5 percentage points. This assumption is the basis for the sample size. The initial aim is to~     recruit about 50 well-baby clinics.~   "
193913|NCT01025349|"~     Bevacizumab is a monoclonal antibody currently used for the treatment of colorectal cancer.~     It works by preventing the formation of new blood vessels (angiogenesis). The drug has been~     shown to inhibit vascular endothelial growth factor (VEGF) activity. Previous research showed~     positive findings in other solid tumors that had metastasized. In this study, the~     investigators are investigating the response of adding bevacizumab to conventional~     chemotherapy for metastatic breast cancer patients.~   "
193914|NCT01025336|"~     The purpose of this study is to evaluate the levels of antibodies 1 year after receiving the~     second vaccine dose in two groups of adults over the age of 60: (1) those who have previously~     received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) and (2) those who have~     previously received 1 dose of 13vPnc and 1 dose of 23-valent pneumococcal polysaccharide~     vaccine (23vPS). This study will also assess whether the use of the 2 vaccines, 13vPnC and~     23vPS, administered in different sequential order results in different prolonged antibody~     levels. This study is limited to individuals who participated in either study 6115A1-3010~     (NCT00574548) or 6115A1-3005 (NCT00546572).~   "
193915|NCT01025323|"~     The purpose of this study is to assess the efficacy of lifestyle modification in reducing~     blood pressure values in Hispanics at risk for hypertension.~   "
193932|NCT01025102|"~     The purpose of this study is to compare the effects and side effects of interscale block~     performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.~   "
193933|NCT01025089|"~     The main purpose of this study is to find out the good and the bad effects that the~     combination of cetuximab with the traditional chemotherapy regimen of cisplatin, doxorubicin,~     and cyclophosphamide has when given to patients with later stage thymoma or thymic carcinoma~     before surgery. The physicians will also look at changes in genes in the tumor that may~     relate to the effectiveness of cetuximab~   "
193949|NCT01024881|"~     Infraclavicular approach of the subclavian veins is commonly used for central venous access.~     Aberrant locations of catheter tip are frequently quoted for this approach, but few studies~     have been performed to document the relationship between the shoulder position and catheter~     tip location. This prospective study was performed to assess the influence of the shoulder~     position on the safe and proper placement of infraclavicular subclavian catheters.~   "
193916|NCT01025310|"~     Background and objectives: There is a general agreement that some types of urban environment~     could be the source of psychological stress as opposed to natural-relaxing environment. A~     number of aesthetical researches found out that the main cause for stress appearance can be~     explained by the complexity and order of the environment. There are also some indications~     that the stressing influence of the open environment can be measured by evaluating eye~     movements, in particular saccadic movements.~      The objective of this study is to characterize eye movements - mainly saccades -while~     presenting visual material of different complexity and order and to evaluate the possible~     relationship between eye movements and parameters of psychological and physiological stress.~      Methods: The research is based on systematic gradual experiments on healthy volunteers, who~     will be tested while viewing series of abstract figures and pictures of natural and urban~     areas with different level of complexity and order. Each figure or picture will be showed to~     subjects for 7 seconds. During the whole experimental session the investigators will measure:~        1. Saccadic and other eye movements using the magnetic scleral search coil technique. The~          magnetic scleral search coil technique is the most sensitive and accurate technique used~          in modern ocular motor research for measuring horizontal, vertical and torsional eye~          movements. The coils are easy to apply and well tolerated over a wearing period of up to~          45 minutes per recording session.~        2. Heart rate pulse will be measured using a commercial pulse-meter.~        3. Aesthetical evaluation: Following each figure or picture 7 seconds presentation;~          subjects will rate it in a scale from 1 (very relaxing) to 10 (very stressful).~      Possible relationship between saccadic eye movements, heart rate and aesthetical rate will be~     analyzed using WIN 11 SPSS and MATLAB in statistically accepted ways.~      Population: A total of about 60 healthy subjects aged 18-60 years old will be recruited for~     the study from students, faculty and staff of Tel Aviv University and of Meir Medical Center.~      Criteria for inclusion: Healthy subject with normal vision~      Criteria for exclusion: Eye disease such as corneal or scleral abrasion or disease, glaucoma,~     refractive errors greater than 2 diopters and concurrent medication with CNS-active agents.~   "
193917|NCT01025297|"~     This study is designed to evaluate the safety of biological active dose of a new experimental~     drug, IL-7, in combination with standard bi-therapy in patients with Hepatitis C chronic~     infection identified as non responders to the standard bi-therapy alone.~   "
193918|NCT01025284|"~     Part A: This study evaluates an experimental treatment in participants with extensive-disease~     in small-cell lung cancer.~      Part B: This study evaluates an experimental treatment in participants with extensive-disease~     in small-cell lung cancer.~   "
193919|NCT01025271|"~     This is a prospective pharmacokinetic study in patients having external ventricular drains~     with suspected external ventricular drain related bacterial meningitis. A single dose of~     daptomycin will be administered for the purposes of the study and PK samples will be obtained~     around this dosing.~   "
193920|NCT01025258|"~     The purpose of this study is to assess the impact of a collaborative active intervention~     program of a multi-disciplinary team on improving adherence to chronic medications and~     improve clinical outcomes in CF patients.~   "
193921|NCT01025245|"~     The purpose of this study is to study the effect of intraoperative magnesium on~     remifentanil-induced postoperative hyperalgesia after thyroidectomy~   "
193922|NCT01025232|"~     The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the~     treatment of recurrent fluid.~   "
193923|NCT01025219|"~     The purpose of this study is to assess the phenotypic candidates symptoms, in patients with~     crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and~     neuropsychological evaluations apt to be associated with genetic and genotypic~     characterisations, notably on the polymorphisms of the genes coding or regulating~     dopaminergic, norepinephrine and serotoninergic systems.~   "
193924|NCT01025206|"~     This is a first in human study which will assess the safety and tolerability of a monoclonal~     antibody against ICAM-1 in patients with Multiple Myeloma. The tumour response rate will also~     be measured.~   "
193925|NCT01025193|"~     If subjects are listed for kidney transplant and are considered sensitized, this means they~     have a high amount of antibodies in their blood that could react to a kidney transplant~     offered for them. Antibodies are protein substances made by the body that fight anything that~     the body considers as a threat to it, such as infection or a kidney transplant. Sensitization~     may be due to prior transplants, pregnancy, or blood transfusions. Being sensitized can~     increase the subject's kidney transplant waiting time as it is more difficult to find a~     suitable kidney transplant for them that their antibodies will not react to. The purpose of~     this research study is to see if giving the investigational drug belimumab up to one year~     pre-transplant can de-sensitize the subjects, or decrease the amount of antibodies in their~     blood. This may help make the subjects eligible to receive a kidney transplant more quickly.~     If after receiving belimumab, the subjects are compatible with a donor kidney offered and are~     medically suitable for transplant at that time, a kidney transplant will be performed.~   "
193926|NCT01025180|"~     A recent study has demonstrated that in low respiratory infections, a strategy using~     prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to~     antibiotics by 47% without prognostic modification.~      The aim is to evaluate the impact on antibiotics consumption of an algorithm using~     procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly~     identified hosted germs or infectious centre.~      This multicenter study is a randomized prospective open study involving 9 ICU departments in~     France, comparing two strategies on antibiotherapy treatment period one based on~     procalcitonin level(experimental group) the other on physician's appreciation(control group)~      140 adult patients should be included with a severe sepsis symptomatology, whose infectious~     etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen~     agent or infectious centre clearly identified.~      The primary outcome is the rate of patients undergoing antibiotic treatment at D5.~      Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay~     in intensive care ward and evolution of the SOFA score between D0, D3 and D5.~      Duration of patient enrollment is 30 days.~   "
193927|NCT01025167|"~     The purpose of the study is to determine the impact of a specific nutrition formula with a~     high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving~     radio-/chemotherapy on body weight, body composition, nutritional status and physical~     function compared to a standard nutrition formula. Using an adaptive design approximately 80~     patients will be randomized in the first part of the study. Following an interim analysis~     further 160 patients may be added, for a total of 240 patients.~   "
193928|NCT01025154|"~     The goal of this clinical research study is to learn if the combination of clofarabine,~     cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who~     are between the ages of 18 and 60 years old. The safety of this study drug combination will~     also be studied.~   "
193929|NCT01025141|"~     The main objective of the investigators' study is to assess the efficacy of a course of~     treatment using skeletal anchorage (MINISCREW) as compared with treatment involving dental~     anchorage (reference) during dentofacial orthopedic treatment.~   "
193934|NCT01025076|"~     Executive Summary~      Aims and Hypotheses of the Study:~      The aim of the study will be to evaluate the safety, effectiveness and early outcome of the~     StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric~     patients. The study will test a hypothesis that the StomaphyX procedure will be effective in~     promoting the loss of regained weight, reducing the risk for comorbidities and improving~     patients' quality of life.~      Type of Study: Prospective non-randomized Study Duration: 12 months Number of Patients: 20~      Inclusion Criteria:~      18-70 years of age, BMI ≥ 35, ≥ 2 years after primary Roux-en-Y gastric bypass with evidence~     of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or~     fluoroscopy. Pts also demonstrate a weight regain of 15% of excess body weight loss.~      Exclusion Criteria:~      Esophageal stricture, or any anatomic conditions that preclude passage of transoral~     endoluminal instruments, has another causal factor for weight regain other than stoma or~     pouch dilatation, portal hypertension, coagulation disorders or chronic use of~     anticoagulants, any active medical condition that would preclude the patient from completing~     the study or would result in an unreasonable risk to the patient.~      Intervention Treatment: Creation of multiple full-thickness plications within the gastric~     pouch using the StomaphyX device (EndoGastric Solutions, Inc., Redmond, WA, USA)~      Evaluation Criteria Primary Outcome: Change in body weight at 6 and 12 months Secondary~     Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life~     scores, waist circumference, co-morbidity resolution Effectiveness and Safety Assessment~     Clinical: Weight, height, waist circumference quality of life questionnaires (Impact of~     Weight QOL-Lite, Eating and Weight Patterns, Three-factor Eating, Emotional Eating Scale, GI~     QoL, GSRS and/or PGWB) Anatomical: Upper GI endoscopy, computed tomography or barium~     radiography Biochemical: Blood and urine tests (glucose, cholesterol, triglyceride, HDL, LDL,~     uric acid) Safety: Adverse events, complications, co-morbidities, hospital stay~   "
193935|NCT01025063|"~     This study will investigate the safety and efficacy of treatment of choroidal~     neovascularization (CNV) due to age-related macular degeneration (AMD) with a combination of~     ranibizumab (Lucentis) and verteporfin PDT (Visudyne), as compared with ranibizumab~     monotherapy.~   "
193936|NCT01025050|"~     This clinical study is an open, prospective, multi-centre eye study consisting of three study~     arms to determine the safety and efficacy of intrastromal incisions for the correction of~     visual acuity on presbyopic eyes. The hypothesis of the study is that by means of~     intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and~     effective way.~   "
193937|NCT01025037|"~     The purpose of this study is to evaluate patient shoulder functional outcomes following~     rotator cuff repairs reinforced with a surgical mesh.~   "
193938|NCT01025024|"~     A single-nucleotide polymorphism (SNP) analysis of DNA obtained from peripheral blood of the~     glaucoma patients and the normal control will be performed to find genetic marker for primary~     open angle glaucoma.~   "
193939|NCT01025011|"~     The purpose of this study is to test a new non-invasive tool to measure hemoglobin in retinal~     arteries.~   "
193940|NCT01024998|"~     This Phase 1 clinical research study will examine the safety and tolerability of an~     experimental gene transfer agent, AAV2-sFLT01, in patients with Neovascular Age-Related~     Macular Degeneration (AMD).~   "
193941|NCT01024985|"~     The purpose of this study is to determine the ability of STRATUS OCT and high resolution OCT~     to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and~     its subtypes.~   "
193942|NCT01024972|"~     Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the~     brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain~     arteries) is a known complication after SAH and significantly increases disability and death~     after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown~     that the muscles in the artery wall play a role in cVSP.~      Dantrolene has been FDA approved and extensively used in clinical practice as a muscle~     relaxant for more than 30 years. It has been shown to provide some benefit in animal studies~     of cVSP, as well as in a small number of humans. However, the first human studies have only~     been observational and over a short period of time.~      This study will evaluate the safety and tolerability of intravenous dantrolene given every 6~     hours over seven days to patients with or at risk for cVSP after SAH. The goal is to~     determine if future efficacy studies should be done to determine if treatment with Dantrolene~     may improve the outcome of patients with cVSP after SAH.~   "
193943|NCT01024959|"~     The objective of this multi-center clinical study is to determine the association of the PCA3~     Score with prostate biopsy outcome and validate the assay's performance characteristics in~     men with previous negative prostate biopsies. An elevated PCA3 Score is thought to be~     associated with an increased likelihood of positive biopsy. The results of this study are~     intended to be used for regulatory filings for use as an in vitro diagnostic test.~   "
193944|NCT01024946|"~     For patients with malignant pleural mesothelioma that has grown despite treatment with~     standard chemotherapy, no treatment has yet proven beneficial. The purpose of this study is~     to find out what effects, both good and bad, that everolimus has on the cancer. Everolimus~     works by blocking a protein that helps the cancer grow. The goal of this clinical research~     study is to learn if the study drug everolimus can shrink or slow the growth of mesothelioma.~     The safety of this drug will also be studied. The patients' physical state, changes in the~     size of the tumor, and laboratory findings taken during the study will help us decide if~     everolimus is safe and effective.~   "
193945|NCT01024933|"~     The primary aim of this study is to evaluate whether an intervention that combines positive~     affect and self-affirmation with motivational interviewing (TRIUMPH) improves blood pressure~     control compared to an educational/behavioral contract intervention at 12 months. We~     hypothesize that a greater proportion of participants in the experimental arm of TRIUMPH will~     have adequate blood pressure control as defined by Seventh Joint National Committee on~     Detection, Evaluation and Treatment of Hypertension (JNC-7.)~   "
193946|NCT01024920|"~     Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and~     to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).~   "
193947|NCT01024907|"~     RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that~     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause~     less damage to normal tissue.~      PURPOSE: This phase I/II trial is studying the best way to give proton beam radiation therapy~     and to see how well it works in treating patients with low grade gliomas.~   "
193948|NCT01024894|"~     This study is designed to evaluate the safety of biological active dose of a new experimental~     drug, IL-7, in combination with standard bi-therapy in Asiatic patients with Hepatitis C~     chronic infection identified as non responders to the standard bi-therapy alone.~   "
193969|NCT01024621|"~     The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the~     biopsy number needed per patient for the detection of gastric intestinal metaplasia without~     the loss of corresponding diagnostic yield.~   "
193950|NCT01024868|"~     For the purpose of assessing the spread of the local anaesthetic after injecting it between~     abdominal muscles on both sides, the investigators will test if the patient can feel a change~     in the perception of cold and warm, as well as being pricked with a blunt needle. The~     investigators will also take several blood samples, together with routine samples, to measure~     the concentration of the local anesthetic in the blood.~   "
193951|NCT01024855|"~     A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at~     specific time points over the course of four days. The study was conducted with PureVision~     lenses.~   "
193952|NCT01024842|"~     In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety,~     tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective~     antiretroviral therapy.~      MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a~     heterologous viral vector boost regimen which will include a replication-defective simian~     adenovirus expressing the same immunogen.~   "
193953|NCT01024829|"~     Increasing (boosting) the radiation dose for patients with non-small cell lung carcinoma to~     the individual maximal dose which can safely be given. The question is if patients should~     receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized~     for one of these two treatment options. All patients will receive 24 radiations. Dose~     increasement will be enabled by a so called integrated boost.~      Furthermore:~      - PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and~     four hours post injection.~   "
193954|NCT01024816|"~     The purpose of this study is to determine whether Restorative yoga versus stretching~     exercises will reduce risk factors for metabolic syndrome in adults with metabolic syndrome.~   "
193955|NCT01024803|"~     Patients suffering from hereditary retinal degeneration receive a retinal implant to restore~     sight.~      Subretinal implant ON results in significant visual acuity improvement, when compared to~     OFF condition.~   "
193956|NCT01024790|"~     The purpose of this study is to test an exercise treatment that includes behavioral~     strategies to improve blood sugar control in women with type 2 diabetes who are depressed and~     overweight.This research study may lead to a potentially useful treatment for diabetes~     management when depression is present.~   "
193957|NCT01024777|"~     The purpose of this study is to determine the safety and the immunologic effects of~     supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with~     multiple sclerosis.~   "
193958|NCT01024764|"~     The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS~     P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe,~     well tolerated and immunogenic. The present study is intended to extend the follow-up of the~     volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and~     cellular immune response. The results of the present study will be key for the design of~     future phase II trials, particularly for the definition of the optimal schedule for boosting~     immunizations.~      All individuals (20) will be enrolled in a 120-weeks observational study and monitored every~     24 weeks for the following 3 years. During these visits, in addition to the hematological and~     biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be~     evaluated.~   "
193959|NCT01024751|"~     The objective of this study is to evaluate the clinical performance of Bausch & Lomb~     investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when~     used by wearers of silicone hydrogel or Group IV contact lenses.~   "
193960|NCT01024738|"~     Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral~     rinse~   "
193961|NCT01024725|"~     A cohort of 4000 community-dwelling adults is followed to evaluate the effectiveness of the~     Finnish national A(H1N1)v influenza vaccination campaign in preventing the first episode of~     laboratory-confirmed A(H1N1)v influenza. The safety of vaccination and the severity of the~     disease are followed primarily from health care registers. In a subgroup of 200 participants,~     the humoral and cellular immunogenicity of the vaccine will be studied.~   "
193962|NCT01024712|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving paclitaxel and carboplatin together with gefitinib may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and~     carboplatin together with gefitinib and to see how well it works in treating patients with~     Stage IIIB or stage IV non-small cell lung cancer.~   "
193963|NCT01024699|"~     The purpose of this study is to determine differences in the XLIF and TLIF procedures with~     respect to perioperative variables in adult patients with low-grade symptomatic~     spondylolisthesis.~   "
193964|NCT01024686|"~     The purpose of this study is to assess safety and tolerability of escalating doses of a~     genetically attenuated parasite malaria vaccine (p52-/p36- GAP vaccine) in healthy~     malaria-naive adults. The study will also assess preliminary efficacy of p52-/p36- GAP~     vaccine following primary experimental challenge with P. falciparum sporozoites. Lastly, the~     study will assess immunogenicity of p52-/p36- GAP in malaria-naïve healthy adults and~     preliminary efficacy of p52-/p36- GAP vaccine following primary experimental re-challenge~     with P. falciparum sporozoites.~   "
193965|NCT01024673|"~     This is study where medical record information will be collected as well as collection of~     excess biological samples.~   "
193966|NCT01024660|"~     The purpose of this study is to determine if there is improvement or measurable change in~     cognition after only one month of treatment with donepezil when using a computerized test~     battery. The results at one month will be compared with the results at 3 months to evaluate~     this.~   "
193967|NCT01024647|"~     The purpose of this study is to determine if increasing the dose and/or dosing frequency of~     certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients~     with moderate to severe Crohn's disease.~   "
193968|NCT01024634|"~     The purpose of this study is to test the effects of endurance exercise training on arterial~     structure and function, and to examine potential mechanisms producing changes in arterial~     structure and function in young (18-35 years of age) African Americans when compared to~     Caucasians.~   "
193971|NCT01024595|"~     The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS~     P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe,~     well tolerated and immunogenic. The present study is intended to extend the follow-up of the~     volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and~     cellular immune responses. The results of the present study will be key for the design of~     future phase II trials, particularly for the definition of the optimal schedule for boosting~     immunizations.~      All individuals (27) will be enrolled in a 120-weeks observational study and monitored every~     24 weeks for the following 3 years. During these visits, which are performed within the~     schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to~     the routine virological, hematological and biochemical assessment, the anti-Tat specific~     humoral and cellular immune responses will be evaluated.~   "
193972|NCT01024582|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided~     accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount~     of normal tissue that needs to be removed.~      PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see~     how well it works in treating patients with early-stage breast cancer.~   "
193973|NCT01024569|"~     The purpose of this research study is to test the effectiveness of a standardized peer-led~     intervention to teach self-management skills in improving outcomes of individuals with a~     severe mental illness. The intervention is known as Wellness Recovery Action Planning or~     WRAP, co-developed by Dr. Mary Ellen Copeland. The focus of the inquiry is on whether and how~     developing an individualized plan for successful living: 1) lowers psychiatric symptoms; 2)~     enhances psychosocial outcomes such as self-perceived recovery, empowerment, self-advocacy,~     coping, and social support; 3) increases knowledge of personal mental illness self-management~     strategies; and 4) enhances satisfaction with the service delivery system. The study~     evaluated the following hypotheses:~      Hypothesis #1: Compared to wait-list control subjects, those who participate in the WRAP~     intervention will report reduced levels of psychiatric symptoms.~      Hypothesis #2: Compared to wait-list control subjects, those who participate in the WRAP~     intervention will report enhanced enhanced feelings of empowerment, hope, recovery, quality~     of life, and functioning.~      Hypothesis #3: Compared to wait-list controls, those who participate in the WRAP intervention~     will report increased levels of social support.~      Hypothesis #4: Compared to wait-list controls, those who participate in the WRAP intervention~     will report increased use of peer services, higher satisfaction with services, and have lower~     overall service costs.~      Hypothesis #5: Compared to controls, those who participate in the WRAP intervention will~     report increased knowledge of mental illness self-management, including making/using a WRAP~     plan.~      Hypothesis #6: There will be no difference in employment rates of control vs. intervention~     subjects.~   "
193974|NCT01024556|"~     The present study is designed as a prospective observational study directed at evaluating the~     frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune~     response in highly active antiretroviral therapy (HAART)-receiving HIV-1 infected~     individuals, and to prospectively evaluate the immunological, virological and clinical~     outcome of anti-Tat positive versus anti-Tat negative subjects under successful HAART~     (secondary endpoint), in order to determine the impact of anti-Tat immunity on HIV disease~     progression as well as the potential use of anti-Tat immune response assessment for the~     clinical and therapeutic management of HAART-treated infected patients. This survey provided~     important information for the design, planning and conduction of future therapeutic vaccine~     trials based on the HIV-1 Tat protein in HAART-treated patients.~   "
193975|NCT01024543|"~     In this study we hypothesize infusion of Angiotensin II improves the insulin-induced~     microvascular dilatation and therefore insulin-mediated glucose uptake. Objectives: Does~     infusion of Angiotensin II increase insulin-mediated glucose uptake via enhanced~     insulin-mediated microvascular function in healthy subjects?~   "
193976|NCT01024530|"~     The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune~     killer cells in treating hepatocellular carcinoma patients in：~        1. Reduction of tumor size~        2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.~   "
193977|NCT01024517|"~     The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage~     formulation (with and without food)and an oral solution, and to assess its safety and~     tolerability.~   "
193978|NCT01024504|"~     This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus~     bevacizumab combination as first-line treatment in elderly patients with metastatic~     colorectal cancer.~   "
193979|NCT01024491|"~     As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg~     for the treatment of premature ejaculation~   "
193980|NCT01024478|"~     The multicenter study evaluates the diagnostic performance of 3.0 T contrast-enhanced~     whole-heart coronary MRA in patients with suspected coronary artery disease.~   "
193981|NCT01024465|"~     A prospective, non-randomized, open-label, multi-center study designed to implant up to~     twenty-six (26) CE-marked ReShape™ Balloons in twenty-six (26) patients with body mass index~     (BMI) 30-40 to assess the effectiveness of the device. The RIB devices will be used within~     their labeled indications and as per their instructions for use. Enrolled patients will be~     followed for seven months. The patient will be prescribed a controlled diet, exercise and~     counseling. One group of 26 patients will receive treatment as follows: Placement, inflate to~     900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of~     placement and removal required).~   "
193982|NCT01024452|"~     Randomized comparison of warfarin dosing quality between the Hamilton nomogram and a~     commercial computer system.~      Hypothesis: Mean TTR of patients managed with the commercial computer system is non-inferior~     to management with the validated Hamilton Nomogram.~   "
193993|NCT01024309|"~     The purpose is to determine if differences exist in the attainment of functional milestones~     that reflect activities of daily living between mini-posterior and direct anterior approach~     total hip arthroplasty (THA). The investigators also hope to determine if the general health~     outcome after direct anterior total hip arthroplasty was better than that after~     mini-posterior-incision total hip arthroplasty as measured with Short Form-12 (SF-12) scores,~     and to evaluate variation of surgical factors of the two procedures on the basis of the~     operative time, component positioning, and occurrence of early complications.~   "
193983|NCT01024439|"~     Laparoscopic appendicectomy is widely practiced in Hong Kong nowadays with shorter hospital~     stay and less wound complications. Most of the time, three small wounds of less than 10mm~     will be adequate enough for the completion of the surgery with minimal pain.~      Recently, the concept of Natural Orifice Transluminal Endoscopic Surgery (N.O.T.E.S) led to~     the attention of single incision laparoscopic surgery (SILS) again in the surgical community.~     SILS is not a new idea. The first SILS for cholecystectomy was reported in 1997 by Navarra et~     al. However, the close proximity of the instruments, limitation in triangulation during~     dissection and suboptimal exposure of the surgical field has made this approach unpopular in~     last decade. Because the concept of N.O.T.E.S and the newly designed access port, surgeons~     are now focused again on SILS. The Chinese University of Hong Kong has recently release their~     preliminary results on the use of SILS on appendicectomy with satisfactory results in terms~     of less post-operative pain and less prominent scar. However, it was a case series with~     limited number of patients. In order to test the advantages of SILS on the management of~     patients with acute appendicitis, a double blinded randomized clinical trial is conducted.~   "
193984|NCT01024426|"~     The investigators propose to assess whether an intervention to build capacity and improve~     delivery of drugs and diagnostics at government-run health facilities improves the health of~     children and quality of care delivered, as compared to 'standard care' currently available at~     health facilities, supplemented by services provided through the private sector and~     community-based interventions. The target population will be divided into 20 clusters,~     defined as the catchment area of lower-level public health facilities. Clusters will be~     randomized to the health facility intervention (HFI) or to standard care delivered from~     government-run health facilities, supplemented by services provided through the private~     sector and community-based interventions. The intervention is designed to address barriers to~     delivering quality care at health centers and will focus on three components: (1) training~     in-charges in health center management, (2) providing training to health workers in fever~     case management and patient-centered services, and (3) ensuring adequate supplies of~     artemether-lumefantrine and RDTs. Outcomes will be measured in three distinct populations:~     (1) cross-sectional surveys of children under 15 years randomly selected from households~     within the clusters; (2) a cohort of children under five randomly selected from households~     within the clusters and followed for 2 years; and (3) patients attending all government-run~     health facilities, including children under five and their caregivers participating in exit~     interviews on selected days every six months. The primary outcome of the study is prevalence~     of anemia in children under five.~   "
193985|NCT01024413|"~     This is a randomized controlled trial to compare efficacy and safety between erlotinib and~     gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were~     randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was~     progression-free survival (PFS).~   "
193986|NCT01024400|"~     The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non~     adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.~      Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at~     delivery and recording temperature and vaccine side effects in a memory aid for 7 days~     following each vaccination. Participants will be involved in study related procedures about 3~     at 5 months.~   "
193987|NCT01024387|"~     The purpose of this research study is to determine the effectiveness of AMG 479 against~     carcinoid and pancreatic neuroendocrine tumors. AMG 479 is an antibody that is made in the~     laboratory. Antibodies are highly specific proteins produced by the body's immune system that~     recognize foreign substances in the body. AMG 479 has been used in other research studies and~     information from those other research studies suggests that AMG 479 may help to prevent the~     growth of some neuroendocrine tumors. The observed antitumor activity of AMG 479, together~     with the current limited treatment options available for patients with neuroendocrine tumors,~     warrant further investigation of AMG 479 in this patient population.~   "
193988|NCT01024374|"~     Clinical single-blind randomized comparison with the overall objective of evaluating the~     clinical efficacy of the products Nutracort lotion and Nutracort cream in the treatment of~     seborrheic dermatitis on the face.~      Will be held clinical and perceived efficacy assessment and instrumental measurements. Each~     product will be applied at half face for 7 consecutive days and all applications will be~     monitored in the research site. 60 volunteers will be recruited.~      Evaluations will be held at the following times: T0 - before the initial application of the~     product; T1 - 24 hours after starting treatment, T2 - 48 hours after starting treatment, T3 -~     72 hours after initiation of treatment, T4 - 96 hours after the start treatment, T7 - 7 days~     after initiation of treatment.~   "
193989|NCT01024361|"~     The objective of the study is to determine if CPAP applied within less than 15 min of life in~     the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days~     of life.~   "
193990|NCT01024348|"~     Extended-release tramadol is indicated for the management of moderate to severe pain in~     adults who require around-the-clock treatment. It provides an extended duration of action,~     more constant plasma concentrations, a reduced dosing frequency, and the potential for~     improved compliance and therapeutic outcomes.~      The present study was designed to evaluate the safety and effectiveness of this medication in~     the treatment of early postoperative pain after knee arthroscopy.~   "
193991|NCT01024335|"~     The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to~     maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that~     administering dronabinol during detoxification and during the first few weeks of naltrexone~     treatment will lead to improved naltrexone tolerability, resulting in better naltrexone~     compliance and treatment retention, and ultimately a reduction in opioid use and relapse~     rates.~   "
193992|NCT01024322|"~     To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen~     (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by~     inducing additional cross-links within or between collagen fibers using UVA light and the~     photo- mediator riboflavin. The purpose of this study is to generate data for presentation at~     medical meetings and for peer-review publication~   "
194255|NCT01020838|"~     To determine the sensitivity and specificity of the visual assessment of tracer uptake in the~     Florbetaben PET images compared to histological verification of the presence or absence of~     cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of~     truth~   "
193994|NCT01024296|"~     During any minimally invasive surgery case, 5-25mm size incisions need to be made to gain~     access to the abdomen. One of the most difficult, time-consuming, and sometimes unreliable~     parts of the case is closing these incisions, especially in obese patients. This is mainly~     because these incisions are very small and the layer that needs to be closed (fascia) rests~     deep underneath the skin and fat tissue of the abdominal wall. Two of the investigators (CM~     and BS) have developed at Stanford an instrument that allows for an easier and more reliable~     closure of these wounds. The purpose of this study is to test this instrument in the closure~     of laparoscopic wounds in obese patients undergoing laparoscopic gastric bypass surgery.~   "
193995|NCT01024283|"~     The principal research objective of this additional research protocol is to support the~     collection, storage and use of tumour and surrogate (peripheral blood mononuclear cells -~     PBMNCs). The objective of this study is to perform assays to study pharmacodynamic (PD)~     markers that confirm target modulation.~   "
193996|NCT01024270|"~     The primary outcome measure in this study was the preoperative cervical width after~     misoprostol administration. The secondary outcomes were duration of cervical dilatation, up~     to Hegar number 10, complications during cervical dilation and the hysteroscopy, and~     misoprostol associated side effects. The cervical width was assessed by performing cervical~     dilatation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar~     dilatators until the dilator could pass through the internal os without resistance. The~     largest one that could be passed was recorded as the initial cervical width.~      The mean cervical diameter, after oral and vaginal misoprostol of 400 μg, has been reported~     to be 6.0 ± 1.5 mm and 7.3 ± 1.6 mm, respectively 4. The investigators hypothesized that~     equivalence was of clinical significance if the difference in the initial cervical width was~     less than 1 mm among groups with the standard deviation of the initial cervical width of 1.6~     mm. The estimated sample size was 47 patients in each group; this would be able to detect an~     equivalent effect in the groups with a power of 80% and a type 1 error (a) of 0.017. Data are~     expressed as the mean ± SD (standard deviation) or median with range or as the number (%) of~     cases.~   "
193997|NCT01024257|"~     PURPOSE: To affirm the effectiveness and complication rate of postoperative single-dose~     beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial.~     METHODS AND MATERIALS: This trial was designed as a prospective, randomized, single center~     study. Surgery was performed in all cases according to the conjunctival autograft technique.~     One thousand and four patients with 108 pterygia were postoperatively randomized to either~     beta-RT or observation. In the case of beta-RT, a (90) Sr eye applicator was used to deliver~     1000 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After~     treatment, both an ophthalmologist and a radiation oncologist performed the follow-up~     examinations. The accumulated data were analyzed using a group sequential test. RESULTS:~     Between February 2007 and September 2008, 104 eyes with primary pterygium were operated on~     according to the trial protocol. Additional treatment was performed within 24 hours~     postoperatively. Four patients were lost to follow-up, resulting in 104 patients who could be~     analyzed. In the 54 eyes randomized to receive beta-RT, 5 relapses occurred compared with 8~     recurrences in the 50 eyes that no received RT, for a crude control rate of 90.7 % vs. 84 %,~     respectively. At a mean follow-up of 9 months (range 4- 18), major treatment complications~     had not been observed . CONCLUSION: Single-dose beta-RT of 1000cGy after conjunctival~     autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary~     pterygium recurrence.~   "
193998|NCT01024244|"~     The purpose of this study is to help answer the following questions:~        -  To test if taking LY2599506 for 12 weeks controls blood sugar better than taking placebo~          for 12 weeks.~        -  To evaluate the safety of LY2599506 in participants with diabetes.~        -  To determine if LY2599506 has the ability to control blood sugar in participants with~          diabetes.~        -  To determine how much LY2599506 should be given to participants.~        -  To determine if LY2599506 has an effect on a participant's weight.~      The study design consists of 4 study periods: a screening period, a 4-week dose adjustment~     period, an 8-week treatment period, and a 4-week follow-up period.~   "
193999|NCT01024231|"~     The purpose of this study is to determine the safety and tolerability of treatment with~     BMS-936558 (MDX-1106) in combination with Ipilimumab (BMS-734016) when given at the same time~     or as a sequenced regimen in subjects with unresectable Stage III or Stage IV malignant~     melanoma (MEL)~   "
194000|NCT01024218|"~     This trial is conducted in Europe. The aim of this clinical trial is to assess the preference~     of 2 different needles used by nurses and health assistants. The trial consists of a handling~     test followed by a 12 week cross-over study.~   "
194001|NCT01024205|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib~     malate before surgery may make the tumor smaller and reduce the amount of normal tissue that~     needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that~     remain after surgery.~      PURPOSE: This phase II trial is studying how well giving sunitinib malate before and after~     surgery works in treating patients with metastatic kidney cancer.~   "
194002|NCT01024192|"~     Primary Objective:~      To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic~     insomnia at the prescription conditions of daily practice~      Secondary Objective:~      To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as~     needed basis.~   "
194028|NCT01023854|"~     The paravertebral block is an alternative in the analgesia epidural the major interest of~     which lives in the catheterisation of the paravertébral space allowing to assure/insure an~     one-sided continuous analgesia.~      The main objective of the study is to bring to light the superiority of the continuous~     paravertébral block, as a supplement to analgesia, in the care of the renal and\or adrenal~     surgery by laparotomy at the adult in terms of consumption of morphine, with regard to the~     classic analgesia classic.~      The main assessment criterion is the consumption of morphine within first 24 postoperative~     hours at the patients benefiting from a paravertébral continuous block besides the classic~     systematic analgesia.~   "
194029|NCT01023841|"~     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily~     application to the upper eyelid margins compared with vehicle in treating eyelash loss or~     hypotrichosis (inadequate or not enough eyelashes) in children.~   "
194003|NCT01024179|"~     Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent~     risk factor for most of acute cardiac event. Current clinical data showed that thin-cap~     fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study~     indicated that patients with ACS had significantly higher incidence of incomplete neointimal~     coverage and malapposition after DES implantation than those with SAP. These findings imply~     that initial native lesion characteristics may be related to different vessel response~     (neointimal coverage and malapposition) after stenting. However, there is little data on the~     relationship between plaque characteristics and vascular response to DES after stent~     implantation evaluated by OCT.~      Therefore, this study was designed to investigate the relationship between initial plaque~     characteristics and stent surface coverage or late malapposition after SES implantation. The~     investigators will use high resolution OCT to assess the initial culprit plaque morphology~     and subsequent vascular response after SES stenting at the time points of post-stenting, 6~     months and 12 months. IVUS will also be performed to evaluate the tissue protrusion,~     malapposition, vessel remodeling at the same time points.~   "
194004|NCT01024166|"~     The goal of this research study is to learn if palliative care patients or caregivers, and~     palliative care physicians or nurses can use a computer program designed to provide~     information about the symptoms and overall health of cancer patients.~   "
194005|NCT01024153|"~     The purpose of this study is to test the effect of active video game play on physical~     activity of 9-13 year old children in their natural home environments. We observe how much~     physical activity children engage in after receiving two different active Wii video games and~     for how long they play. Active video games offer promise of minimizing children's physical~     inactivity.~   "
194006|NCT01024140|"~     The primary aim of this pilot study is to test the efficacy of the selective serotonin~     re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD)~     in an open clinical trial.~      A secondary aim is to determine whether treatment with escitalopram increases plasma~     allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are~     correlated with treatment efficacy.~   "
194007|NCT01024127|"~     This research trial studies deoxyribonucleic acid (DNA) in blood or bone marrow samples from~     younger patients with acute myeloid leukemia. Studying samples of blood and bone marrow from~     patients with cancer in the laboratory may help doctors learn more about changes that occur~     in DNA and identify biomarkers related to cancer. It may also help doctors predict how well~     patients will respond to treatment.~   "
194008|NCT01024114|"~     The purpose of this pilot study is to investigate the potential clinical benefits of~     combining two new diagnostic tools to provide co-registered anatomical and functional~     information in the breast in patients with suspected breast cancer.~   "
194009|NCT01024101|"~     The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given~     weekly in patients with advanced or recurrent head and neck cancer~   "
194010|NCT01024088|"~     To estimate, in a longitudinal and not invasive way, in patients with SGB at respiratory~     risk, the function of respiratory muscles and that of the upper airways muscles by~     investigating the force of the tongue, the gulp, and the breath during the sleep to be able~     to detect bulbar impairment and establish correlations enter the various parameters to~     estimate better the interactions between the dysfunction of the respiratory muscles and that~     upper airways muscles and so determine the risk acute respiratory failure.~   "
194011|NCT01024075|"~     Dexamethasone added to sinufoam, which is placed in the ethmoid cavity at the completion of~     endoscopic sinus surgery, will improve sinonasal mucosal healing.~   "
194012|NCT01024062|"~     The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given~     weekly in patients with advanced or recurrent non-small cell lung cancer~   "
194013|NCT01024049|"~     The diagnosis of asymptomatic left ventricular dysfunction is difficult in general practice~     since it requires transthoracic cardiac echocardiography that is generally performed in~     specialized services. Although blood BNP levels monitoring can be of some help in heart~     failure diagnosis is is mostly a late biomarker that is secreted upon heart stretch and has~     many limitations. Therefore the aim of this study is to identify new specific blood~     biomarkers that would help for asymptomatic left ventricular dysfunction diagnosis in large~     populations with cardiovascular risk.~   "
194014|NCT01024036|"~     The purpose of this study is to demonstrate that CNTO 328 when administered in combination~     with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic~     response (complete response or partial response) among patients with Multicentric Castleman's~     Disease.~   "
194015|NCT01024023|"~     Early walking aids are routinely used in UK for rehabilitation of patients with below knee~     amputations. The two main walking aids used commonly in practice include the non-articulated~     Pneumatic Post Amputation Mobility Aid (PPAM)and the Articulated Amputee Mobility Aid (AMA).~     There is no published evidence on whether the articulated walking aid improves knee control~     and shortens delivery time. This study was designed to test the hypothesis that an~     articulated early walking aid has benefit to transtibial amputee compared to non-articulated~     early walking aid.~   "
194016|NCT01024010|"~     RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving ofatumumab~     together with pentostatin and cyclophosphamide may be a better way to block cancer growth.~      PURPOSE: This phase II trial is studying how well giving ofatumumab together with pentostatin~     and cyclophosphamide works in treating patients with untreated chronic lymphocytic leukemia~     or small lymphocytic lymphoma.~   "
194017|NCT01023997|"~     The purpose of this study is to compare the central corneal thickness measurement in patients~     with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular~     hypertension and normal controls and to evaluate the value of corneal thickness in the~     diagnosis and management of glaucoma.~   "
194051|NCT01023555|"~     The purpose of this study is to determine whether the use of a single blood sample of 1cc in~     an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc~     in 2 (aerobic and anaerobic) bottles for blood cultures in neonates.~   "
194018|NCT01023984|"~     Objective: Recent non-randomized studies suggest that extended endoscopic submucosal~     dissection (ESD) is equally effective in removing large rectal adenomas as transanal~     endoscopic microsurgery (TEM). If equally effective, ESD might be a more cost-effective~     approach as this strategy does not require expensive equipment, general anesthesia and~     hospital admission. Furthermore, ESD appears to be associated with fewer complications. In a~     randomized trial we will compare the cost-effectiveness and cost-utility of TEM and ESD for~     the resection of large rectal adenomas.~      Study design: 15 centers will participate in this multicenter randomized trial comparing TEM~     versus ESD.~      Study population: Patients with a large rectal adenoma (≥2cm), located between 2 and 15 cm~     from the anal verge. Invasive cancer is excluded by histopathology and endoscopic~     ultrasonography. Patients must be in a health condition that permits general anesthesia.~      Interventions: Patients will be randomized between~      a. TEM: under general anesthesia b. ESD under sedation~        1. a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will~          be dissected en bloc by a full thickness excision, after which the patient will be~          admitted to the hospital.~        2. an endoscope will be inserted into the rectum and the submucosa underneath the lesion~          will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated~          Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the~          submucosal plane in an eb-bloc fashion, after which the patient will be observed for at~          least 24h in-hospital.~      Primary Endpoint: incidence of recurrence at 12 months~      Secondary Endpoints:~      morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or~     medical intervention) anorectal function. disease specific and general quality of life;~     number of days not spent in hospital from initial treatment until 2 years afterwards; adenoma~      Sample size: Assuming a comparable baseline recurrence rate for TEM and ESD of 6% and~     considering an upper limit of 10% for ESD to be non-inferior (beta-error 0.2 and one-sided~     alpha-error 0.05), 60 patients are needed per group. These numbers provide sufficient power~     to reveal relevant differences in expected morbidity and in number of days not spent in~     hospital.~      Economic evaluation: A cost-effectiveness and cost-utility analysis of ESD against TEM for~     large rectal adenomas from a societal perspective with respectively the costs per recurrence~     free patient and the cost per quality adjusted life year as primary outcome measures.~   "
194019|NCT01023971|"~     The purpose of this study is to determine the changes in macular function during anti-VEGF~     treatment for neovascular age-related macular degeneration.~   "
194020|NCT01023958|"~     The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in~     patients with locally advanced, metastatic or recurrent urothelial cancer after failure of~     first line or adjuvant/neoadjuvant chemotherapy.~   "
194021|NCT01023945|"~     The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose~     and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety,~     tolerability and pharmacokinetics are also evaluated.~   "
194022|NCT01023932|"~     The electrical stimulation generated by the Cochlear Implant (CI) may improve the neural~     synchrony and hence contribute to the development of auditory skills in patients with~     Auditory Neuropathy / Auditory Dys-synchrony (AN/AD). Goal: The goal of the research was to~     evaluate the auditory performance and the characteristics of the electrically evoked compound~     action potential (ECAP) in a group of 18 cochlear implants recipients with AN/AD.The auditory~     perception was evaluated by sound field thresholds and speech perception tests. To evaluate~     ECAP's characteristics, the threshold and amplitude of neural response together with the~     amplitude growth and recovery functions were evaluated at 80Hz stimulation rate.The CI was~     seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients~     considered by the research. The auditory perception benefits as well as the possibility to~     measure the ECAP showed that the electrical stimulation could compensate the neural~     dys-synchrony caused by the AN/AD. However, a unique clinical procedure cannot be proposed at~     this point. Therefore, a careful and complete evaluation of each AN/AD patient before~     recommending the Cochlear Implant is advised~   "
194023|NCT01023919|"~     Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis.~     Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI)~     are poor in patients with DM compared with those without DM. Autopsy study has shown delayed~     neointimal healing with inadequate endothelialization and persistent stent surface ﬁbrin~     deposition after DES implantation in DM patients. This might partially contribute to the high~     risk of late stent thrombosis.~      YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with~     micro porous surface. However, limited data is available in vivo about the surface coverage~     after stent implantation in DM patients because of lack of sensitive imaging modalities.~     Optical coherence tomography (OCT) is an optical analogue of intravascular~     ultrasound（IVUS）that allows high-resolution tomographic intravascular imaging. Furthermore,~     several studies have demonstrated the feasibility of OCT to quantitatively evaluate the~     surface coverage and stent conditions in the follow up after PCI .~      Therefore, the aim of this study was to analyze the surface coverage and late malapposition~     after two types of DES implantation in DM patients compared with non-DM patients by using OCT~     and IVUS~   "
194024|NCT01023906|"~     The purpose of the Taste Perception Study is to assess variations in the ability to taste and~     perceive sensations from various stimuli in younger (18-49 years) and older (50-85 years)~     volunteers. The study's goal is to determine how these sensations influence what one likes to~     eat, and what one chooses to eat, and whether there is an association with dietary intake,~     body composition and chronic disease. Another objective of the study is to determine the~     association between variations in oral sensations and genes mediating sensory perception and~     dietary behaviours.~   "
194025|NCT01023893|"~     Prospective, real-time observational study of hemodialysis patients treated with~     erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets. Subjects will~     be evaluated dynamically for their blood viscosity status at the beginning and end of the~     dialysis treatment, and followed prospectively to assess outcomes. Blood specimens will be~     collected via the subject's hemodialysis port pre- and post-hemodialysis per study assessment~     visit. Blood will be analyzed at a designated laboratory facility for viscosity over a~     comprehensive range of shear rates and tested for intradialytic surges in blood viscosity.~     Subjects will be followed for 48 weeks.~   "
194026|NCT01023880|"~     The primary objective for part 1 of the study is to determine the maximum tolerated dose~     (MTD) of CEP-18770 in patients with relapsed and refractory multiple myeloma. The primary~     objective for part 2 is to evaluate the antitumor activity of CEP-18770 in patients treated~     at the MTD.~   "
194027|NCT01023867|"~     To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and~     Mixed Dementia.~   "
194052|NCT01023542|"~     The primary objective of the trial is to evaluate efficacy and safety of delayed introduction~     (up to 30 days post-transplantation in patients without signs of acute rejection that had~     received an aIL-2 induction and MMF) of either cyclosporine or everolimus versus a 5-day~     delay of cyclosporine in combination with MMF.~   "
194053|NCT01023529|"~     The purpose of this study is to assess the effect of palliative pelvic radiation on symptoms~     and quality of life among patients with incurable prostate and rectal cancer.~   "
194030|NCT01023828|"~     Summary:~      Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the world.~     This neoplasia has a poor survival prognosis due to the low effectiveness of existing~     treatments. The low effectiveness is associated with the development of an intrinsic and~     acquired resistance of tumors, which clinically shows through early progression and~     transitory responses. Tobacco smoking is the major risk factor for NSCLC; however, wood smoke~     has been described as a strong carcinogen and a relevant risk factor for the development of~     NSCLC. Current data indicates that lung tumors associated with tobacco smoking and wood smoke~     show different clinical characteristics, which suggests that they might also have different~     genetic alterations, which are a consequence of tumor etiology. The description of the~     frequency and the type of mutations associated with different etiologies of NSCLC could~     represent the starting point for benefiting each patient according to their specific~     characteristics. One of the most researched signaling pathways related to cancer cell~     proliferation is the one activated by the K-RAS oncogene. Active K-RAS mutations have been~     detected in different types of neoplasia and more than 90% of these mutations occur at codon~     12 of the oncogene. These mutations seem to be an independent risk factor for the prognosis~     of malignant tumors and they are associated with the lack of response to erlotinib, which is~     a tyrosine-kinase inhibitor. The investigators' research team has recently reported that wood~     smoke is an independent factor for survival and response to the erlotinib treatment, which~     suggests that this carcinogen could have a different frequency and pattern of mutations in~     the K-RAS oncogene, compared to what has been reported in smoking patients. Determining the~     tumor mutations within the K-RAS oncogene can help improve the response prognosis of patients~     with advanced NSCLC who have a background of exposure to different factors associated with~     the appearance of this neoplasia, such as wood smoke exposure or tobacco smoking. Therefore,~     the objective of this research is to determine the frequency and the type of mutations at~     codon 12 of the K-RAS oncogene in patients with NSCLC who have a background of exposure to~     tobacco smoking or wood smoke.~   "
194031|NCT01023815|"~     This study will compare the following immunosuppressive regimens in recipients of kidney~     transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and~     cyclosporine given twice a day with steroid withdrawal; C) everolimus, cyclosporine given~     twice a day and continuous steroids. The purpose of this study is to evaluate regimens A and~     B in comparison with the control group (group C) for efficacy, using as main endpoint the~     treatment failure rate, a composite endpoint including death, graft loss, BPAR and lost to~     follow-up between randomization and Month 12.~   "
194032|NCT01023802|"~     In patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone~     therapy molecular breast imaging (MBI) is an accurate test for assessing response rate to~     neoadjuvant therapy.~   "
194033|NCT01023789|"~     The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the~     ABSORB Bioresorbable Vascular Scaffold (BVS) System~      ABSORB BVS is currently in development at Abbott Vascular.~   "
194034|NCT01023776|"~     The purpose of the study is to determine the amount of live virus that can be recovered from~     the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to~     describe the immune response to vaccination.~   "
194035|NCT01023763|"~     The primary objective for the project is to evaluate whether nursing home residents who~     require intravenous fluids and intravenous antibiotics, can be treated just as well or even~     better in the nursing home as in the hospital. In Vestfold, Norway, a structured training~     program in the intravenous treatment of dehydration and infections in nursing homes is~     planned. The 3IV study will evaluate if this leads to an equal or better patient trajectory~     and reduced hospital admittance.~   "
194036|NCT01023750|"~     Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of~     patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and~     LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there~     are no screening tests to identify poor responders. Genetic and environmental factors may~     explain the high variability in response. Although exploratory in nature, this study is of~     clinical and public health importance because prediction of drug response among those with~     hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large~     ($90 to $130/patient/month); targeting the responsive patients at the outset will help~     improve treatment outcomes at a lower cost. If successful, the investigators will propose to~     conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate~     response.~   "
194037|NCT01023737|"~     This study is an open label non randomized study of hydroxychloroquine (HCQ) with histone~     deacetylase (HDAC) inhibitor Vorinostat in patients with advanced solid tumors to determine~     the maximum tolerated dose (MTD) and to evaluate the safety and antitumor activity of this~     drug combination.~   "
194038|NCT01023724|"~     Approximately 50 patients undergoing cataract surgery will be randomized in an even~     allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09%~     BID. Patients will be instructed to begin dosing study medication in the operative eye the~     day before surgery and continue dosing until day 14. KOWA flare measurements will be~     performed at postoperative day one and postoperative day 14. The amount of anterior chamber~     inflammation (flare) will be objectively measured.~   "
194039|NCT01023711|"~     The purpose of this study is to describe the immune response to a novel H1N1 influenza~     vaccination in healthy adults, and to understand the factors that allow healthy adults to~     respond to a single dose of vaccine even if they have never previously experience novel H1N1~     disease or vaccination.~   "
194040|NCT01023698|"~     Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in~     a single session using low fluence parameters?~   "
194041|NCT01023685|"~     This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections~     of CAD106 in Alzheimer's Patients.~   "
194042|NCT01023672|"~     This research study is to examine the effects of the study medication Armodafinil in patients~     with dementia with Lewy bodies (DLB).~      DLB is associated with memory and other thinking problems, excessive daytime sleepiness,~     hallucinations, delusions, apathy, and reduced quality of life.~      One type of medication that could potentially improve daytime sleepiness, memory and thinking~     skills, hallucinations, delusions, apathy, and quality of life is known as a wake-promoting~     medication. Armodafinil is a wake-promoting medication that has been developed for treatment~     of patients with narcolepsy, sleep apnea, and other disorders which cause excessive daytime~     sleepiness.~      The drug used in this study is considered investigational, which means it has either not been~     approved by the Food and Drug Administration (FDA) for routine clinical use or for the use~     described in this study. However the FDA has allowed the use of this drug/device in this~     research study.~      In this study, patients with DLB will receive daily oral Armodafinil tablets, and their~     response to treatment will be assessed over 12 weeks. This study does not involve any placebo~     medication, so all patients will receive Armodafinil treatment.~   "
194054|NCT01023516|"~     The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in~     symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD~   "
194043|NCT01023659|"~     Bupropion and varenicline are indicated for smoking cessation. The objectives of this study~     are two-fold: (1) to explore the logistic feasibility of distributing bupropion and~     varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada~     and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in~     Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who~     smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will~     enroll via the study website, visit their physician to receive a prescription for bupropion~     or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison~     group. All participants will receive weekly motivational emails for 12 weeks. Abstinence~     measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of~     eligible participants who were able to confirm an appointment with a physician to receive the~     prescription will be also measured.~   "
194044|NCT01023646|"~     The purpose of this study is to determine the variability in glycemic index determinations~     for individual foods and food combinations. The study will also evaluate the changes in~     insulin and free fatty acid levels, plasma lipid and lipoprotein profiles, C-reactive~     protein-a marker of inflammation and glycosylated hemoglobin- a marker of glucose metabolism~     during a five-hour period after eating the food or foods. Additionally, supplementary data on~     variation in oral sensation, habitual food intake, food preferences and genes mediating~     sensory perception and dietary behaviors (supported by a grant from the Tufts Ross Aging~     Initiative) will be related to the outcomes on the present study.~   "
194045|NCT01023633|"~     Previous OPTIMOX1 study investigated the use of oxaliplatin discontinuation and~     reintroduction in a novel stop-and-go strategy. Previously untreated patients were randomly~     assigned to either FOLFOX4 administered every 2 weeks until progression (arm A) or FOLFOX7~     for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7~     for another 6 cycles (arm B). Data showed that there was no significant difference in median~     progression-free survival (PFS) and overall survival (OS) between two arms. Furthermore, this~     study showed lower Grade 3 neurotoxicity rate in arm B (17.9% vs 13.3%, P = 0.12).In order to~     investigate the efficacy and feasibility of the novel Stop and go strategy in Chinese mCRC~     patients, Prof. Shu Yongqian in JiangShu Province Hospital plans to conduct a randomized~     controlled study to compare continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st~     Line mCRC patients. To avoid the high oxaliplatin dosage related neurotoxicity, FOLFOX4~     regimen is chosen in this study.~   "
194046|NCT01023620|"~     This study is being done to better understand why people with HIV who have taken drugs for~     HIV begin to show abnormal changes in fat loss or fat gain in their bodies. This condition is~     called lipodystrophy.~      Patients who take medicine for HIV and who have lipodystrophy report loss of subcutaneous~     (sc) fat from the arms, legs, and face and excess fat gain in the neck and truncal region.~     They also more likely to have problems with insulin in the body, high fat levels in the blood~     and diabetes. The reason that lipodystrophy develops is not fully understood although some~     HIV drugs have are very likely the cause. The complications pose an increased risk of fat~     blockage forming in the arteries making you more at risk for heart problems in the future.~     Changes in body fat can cause physical discomfort and psychological distress. Management of~     these problems can be a challenge for the patient's doctor.~      The investigators propose data collection to determine if there is more than one reason why~     this might happen in some people and not in others. Laboratory samples being collected: 1)~     special imaging of the liver; 2) fat collected by needle from the mid thigh and mid-shoulder~     areas; 3) blood samples to measure the virus, t-cells, fats, and other markers of how the~     patient's body is handling the virus.~      This study is being done because science does not fully understand why some patients with HIV~     who take medicines for the virus have abnormal fat loss or gain and some do not. This~     research study is intended to help us better understand why and how this happens.~   "
194047|NCT01023607|"~     Many trials suggested that lipid lowering therapy could significantly reduce cardiovascular~     events. Enhancing stability of vulnerable plaque is probably the main reason by which statins~     reduce adverse coronary events. The size of lipid core and the fibrous cap thickness (FCT)~     are the major determinants of plaque vulnerability. So, it is very important to accurately~     evaluate changes in plaque after stains therapy.~      Previous reports suggested that intensive lipid lowering therapy provide more significantly~     clinical benefit compared with moderate lipid lowering therapy.Such benefit may contribute to~     the changes in following parameters: FCT, lipid arc(quadrants), TCFA, macrophage, plaque~     disruption, and thrombus measured by OCT, and plaque burden and remodeling index by IVUS.~      Current intravascular imaging modalities, such as optical coherence tomography (OCT) and~     intravascular ultrasound (IVUS) can provide in vivo quantitative and qualitative information~     of coronary plaques. However, there were few studies aimed at monitoring the progression of~     coronary plaques in patients receiving statin therapy by OCT combined with IVUS.~      Therefore, the study we designed were to compare the effect of the rosuvastatin 10mg,~     atorvastatin 20mg and atorvastatin 60mg treatment on the changes in FCT and lipid core arc by~     OCT and plaque burden by IVUS of coronary atherosclerotic plaques.~   "
194048|NCT01023594|"~     Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To~     reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy.~     There are two distinct methods of pancreatic stent insertion: internal stent and external~     stent. There was few studies comparing these methods in preventing pancreatic fistula.~     Furthermore, its long-term effect was not known enough. The purpose of this study is to~     determine which is the best method in preventing pancreatic fistula and to investigate its~     long term clinical outcomes.~   "
194049|NCT01023581|"~     The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined~     with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.~   "
194050|NCT01023568|"~     The purpose of this study is to compare the effectiveness of two novel videolaryngoscope~     systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in~     pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope~     devices, Glidescope and Truview provide better laryngeal views in pediatric patients as~     measured by Cormack and ehane (C&L) (1 to 4, 4 the worst), without increasing the time taken~     to intubate (TTI), compared with direct laryngoscopy (DL).~      The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke~     less hemodynamic response and fewer episodes of de-saturation in pediatric patients.~   "
194059|NCT01023451|"~     The purpose of this study is~        1. To determine if Brain natriuretic peptide levels correlates with elevated tricuspid~          regurgitation flow velocity levels in pediatric patients with sickle cell disease~        2. To determine the role of age, gender, steady state hemoglobin and disease type on Brain~          natriuretic peptide levels and pulmonary hypertension~   "
194060|NCT01023438|"~     The purpose of the study is to assess whether primary care physicians may uptitrate~     recommended drug therapies in stable heart failure patients if educational material and~     specialist support including phone or mail consultation are provided~   "
194061|NCT01023425|"~     To compare the clinical efficacy of donepezil between the naive group and the switching~     group.~   "
194062|NCT01023412|"~     Major surgery is still associated with a high rate of postoperative morbidity despite~     improved techniques in surgical management. Surgery-induced alterations of the immune system~     are well described and may play a role in the genesis of postoperative complications. It has~     been shown by several large scale clinical trials, that the use of immunonutrition in~     postoperative cancer surgery, trauma and critically ill patients resulted in an improved~     immunocompetence and/or reduced postoperatively infectious morbidity and/or length of~     hospital stay.The pre-operative regimen was between 5 to 7 days of treatment. The aim of this~     trial is to evaluate if a shorter administration of 3 days pre-operatively would be~     beneficial as well.~   "
194063|NCT01023399|"~     The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain~     Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus~     amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate~     plus amodiaquine implementation program and 24 months later.~      The secondary objectives are Clinical and biological tolerability Evolution of gametocyte~     carriage Proportion of patients without fever at Day 3 Proportion of patients without~     parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite~     sensibility to amodiaquine~   "
194064|NCT01023386|"~     This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of~     YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients~     with advanced cancer~   "
194065|NCT01023373|"~     The aim of the study is to value, in patients with chronic kidney disease and hypertension,~     whether medical therapy plus interventional renal artery revascularization is superior to~     medical therapy alone for the treatment of hemodynamically significant (>70%) atherosclerotic~     renal artery stenosis, diagnosed by duplex doppler ultrasonography and confirmed by magnetic~     resonance angiography, in terms of avoidance of the progression of renal damage, control of~     hypertension and in reducing the cerebro and cardiovascular complications.~   "
194066|NCT01023360|"~     Currently, drugs commonly used for antiplatelet are aspirin and clopidogrel when encountering~     stroke or coronary heart disease. In this study, we would use VASP assay and~     thromboelastograph with platelet mapping assay kit to evaluate the antiplatelet resistance in~     general population and the relationship between clopidogrel and proton pump inhibitor.~   "
194067|NCT01023347|"~     This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel~     loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.~   "
194068|NCT01023334|"~     The purpose of this study is to determine whether intraocular lidocaine increases patient~     comfort during the different stages of MSICS while under topical anesthesia.~   "
194069|NCT01023321|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)~     and multiple (MD) oral dose of GLPG0555 compared to placebo.~      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple~     oral administration will be evaluated, and, if applicable, the maximum tolerated dose~     determined.~   "
194070|NCT01023308|"~     Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of~     HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded~     protein aggregates and triggers myeloma cell death. Combination of pan-DAC and proteasome~     inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated~     synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore,~     clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat~     and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and~     manageable toxicity profile.~      Given the medical need for improved treatment strategies for patients with previously treated~     and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind,~     placebo-controlled, parallel group Phase III study is to compare the results in~     progression-free survival of 2 combination therapies, panobinostat with bortezomib and~     dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously~     treated MM who recurred after 1-3 prior lines of therapy~   "
194071|NCT01023295|"~     The primary objective of this study is to examine effects of fosbretabulin tromethamine~     (fosbretabulin) on PCV as reflected by a change from baseline in the number of polypoid~     lesions on indocyanine green angiography (ICGA).~   "
194072|NCT01023282|"~     The study will evaluate the safety and tolerability of ACR325 in Parkinson disease patients~     and evaluate the effect on levodopa induced dyskinesias.~   "
194073|NCT01023269|"~     The study is designed to demonstrate that treatment with low level stimulation of the bladder~     muscles reduces symptoms of urinary incontinence in comparison with no stimulation.~   "
194074|NCT01023256|"~     GM-CSF is considered to have a key role in the initiation and progression of arthritic~     inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy,~     pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF,~     in patients with active rheumatoid arthritis.~   "
194112|NCT01022762|"~     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood~     glucose lowering effect and the safety profile of repaglinide given alone compared to~     gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated~     with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of~     repaglinide on the phases of insulin secretion as a subgroup study.~   "
194256|NCT01020825|"~     The purpose of this extension is to investigate and confirm the long-term (6 months) safety~     and efficacy of the preceding FATT-1 trial [ClinicalTrials.gov identifier: NTC00475410],~     which studied patients with perianal fistula treated having received adipose-derived adult~     stem cell (ASC)and/or fibrin glue.~   "
194075|NCT01023243|"~     The investigators propose to use a Natural Language Processing System (NLP) to provide an~     initial baseline report for primary care patients at risk for diabetes and cardiovascular~     complications that will include: a) evidence of foot exam documentation in the previous year;~     b) use of aspirin for cardiovascular risk reduction; and c) tobacco use. As part of a~     randomized trial, we plan to use a previously validated mailed survey (NCQA Provider~     Recognition Program) that requests information on the last foot exam, use of aspirin and~     tobacco. Patients who have been identified by NLP as not having had a foot exam will be~     randomized into treatment and control arms. Both arms will receive an informational letter;~     with a second mailing to nonresponders after one month, describing the key strategies for~     effective patient-physician communication during the clinical encounter. The treatment arm~     will also receive an informational letter and patient education brochure containing key~     messages about the importance of regular foot examinations. NLP will be repeated after 6~     months to compare the impact of the patient education materials.~   "
194076|NCT01023230|"~     The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine~     will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and~     immunological responses in chronic hepatitis B (CHB) patients.~   "
194077|NCT01023217|"~     The presence of persistent inadequate or suboptimal virologic response is a strong risk~     factor for viral resistance and breakthrough and also for disease progression of chronic~     hepatitis B, and thus, a change in therapy is required. The combination of entecavir (ETV)~     and adefovir (ADV) is a promising treatment for patients with lamivudine (LAM)-resistance who~     show suboptimal response to the combination of LAM and ADV.~      In this randomized, open labeled trial,the investigators will compare the efficacy of~     continuation of ADV plus LAM versus switch to ADV plus ETV in adults with LAM-resistant~     chronic hepatitis B who shows suboptimal response to the combination treatment of ADV and~     LAM.~   "
194078|NCT01023204|"~     The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given~     weekly in patients with advanced or recurrent breast cancer~   "
194079|NCT01023191|"~     Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. When your~     kidneys fail, harmful wastes build up in your body and your body may retain excess fluid.~     When this happens, you need treatment to replace the work of your failed kidneys. This may be~     with a dialysis machine using haemodialysis or with fluid in the abdomen or peritoneal~     dialysis.~      In peritoneal dialysis, a tube called a catheter is put in the abdomen wall and used to fill~     your abdomen with a cleansing liquid called dialysis solution. The walls of your abdominal~     cavity are lined with a membrane called the peritoneum, which allows waste products and extra~     fluid to pass from your blood into the dialysis solution. These wastes and fluid are removed~     from the body when the dialysis fluid is drained and replaced with a fresh solution.~      The tubes or catheters used to exchange the fluid are currently positioned using a general~     anaesthetic (with the patient awake) and an operation with a cut under the belly button.~     Newer techniques using local anaesthetic (with the patient awake and the area numbed) and~     requiring only a small cut in the skin have been used. No one has ever directly compared the~     two techniques.~      The investigators aim is to perform a direct comparison between the two techniques to look at~     the complications and time required for surgery and length of hospital stay required. The~     investigators will also look at the patients satisfaction and pain scores with each technique~     to help gather evidence as to which is likely to be the best technique to use from now on.~   "
194080|NCT01023178|"~     To directly compare the safety (by laboratory evaluation) and efficacy (feminization and~     growth) of three commonly used estrogen preparations in adolescent patients with ovarian~     failure, either due to congenital causes (Turner syndrome) or medical therapies. We~     hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable~     safety profile in comparison with conventional oral estrogen replacement.~   "
194081|NCT01023165|"~     The purpose of this study is to determine if restoring normal metabolic function in patients~     with type 1 or type 2 diabetes can improve the impact of the consequences of diabetic~     complications on the overall health and quality of life for diabetic patients.Patients are~     treated once per week with intensive bolus intravenous insulin delivery mimicking normal~     insulin secretions in a non diabetic individual. Baseline and periodic diagnostic tests are~     performed and questionnaires completed to evaluate and monitor progress and outcomes.~   "
194082|NCT01023152|"~     The purpose of this study is to study the effect of remote ischemic preconditioning on acute~     kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary~     bypass.~   "
194083|NCT01023139|"~     There are few studies that look at sustained weight loss in the adolescent population. This~     study uses a multidisciplinary approach along with pharmacotherapy (use of Meridia)to~     motivate and establish behavior changes in adolescents (12-18yo) during the first phase of~     the study.~      The second phase will have those who have lost at least 5% BMI to be randomized into one of~     two groups. This first group will have no intervention and will be followed at 3 and 6 months~     to assess for weight loss maintenance. The second group will continue on with monthly~     behavior modifications and also be evaluated at 3 and 6 months.~      The hypothesis proposed is that, 1)there will be sustained weight loss at the end of one year~     in both arms as compared to baseline BMI, 2) and the arm with the behavioral therapy~     intervention will be more successful than no intervention at weight loss maintenance.~   "
194084|NCT01023126|"~     Adherence to obesity treatment programs has been a limiting factor to good results in loosing~     weight. This study aimed to verify if obese subjects submitted to a physical exercise program~     and group psychotherapy would have a greater adherence, than obese people exercising only.~   "
194085|NCT01023113|"~     Lacunae in Knowledge No study is available in literature regarding visual field impairment in~     proliferative diabetic retinopathy comparing conventional double frequency Nd:YAG panretinal~     photocoagulation with PASCAL panretinal photocoagulation~      AIMS & OBJECTIVE~        1. To compare visual field impairment in conventional double frequency Nd: YAG panretinal~          photocoagulation with PASCAL panretinal photocoagulation.~        2. To examine the effect of these modalities of laser on macular edema~      60 eyes of proliferative diabetic retinopathy will undergo humphery visual field analysis,and~     optical coherence tomography before and after panretinal photocoagulation~   "
194086|NCT01023100|"~     This study will test the palatability of several different CP-690,550 oral preparations in~     trained product tester healthy volunteers.~   "
194087|NCT01023087|"~     Colistin is a relatively old antibiotic drug which its use has been abandoned through the~     1970s because it was considered nephrotoxic.~      Recently ( the last decade) it has been reappraised because multidrug resistant Gram negative~     bacteria have emerged causing life threatening infections with no other good enough~     treatment. Moreover, more controlled studies from the recent years show less toxic effect of~     the drug.~      The investigators' study is a prospective study comparing renal function in a group of~     hospitalized patients with sepsis (infection) receiving intravenous treatment with Colistin~     (antibiotics) with a control group which its patients receive other non nephrotoxic~     antibiotics.~      The investigators' study hypothesis is that patients receiving Colistin would have renal~     function decline in higher rates than those seen usually in hospitalized patients in the~     Internal medicine wards with sepsis.~      Another goal of the study is to find correlation between Colistin levels in the plasma (after~     Colistin reaches steady state) and nephrotoxicity seen during or after use of this drug.~   "
194088|NCT01023074|"~     The purpose of this study is to characterize the central auditory processing (CAP) deficits~     that result from multiple sclerosis (MS).~   "
194089|NCT01023061|"~     This phase II trial studies the side effects and how well abiraterone acetate, prednisone,~     and leuprolide acetate or goserelin before and during radiation therapy works in treating~     patients with localized or locally advanced prostate cancer. Androgens can cause the growth~     of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide~     acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation~     therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and~     leuprolide acetate or goserelin before or together with radiation therapy may be an effective~     treatment for prostate cancer.~   "
194090|NCT01023048|"~     Gene Security Network has developed a novel technology called Parental SupportTM (PS) which~     is used for Preimplantation Genetic Screening/Diagnosis (PGS/D) during in vitro fertilization~     (IVF). This technology allows IVF physicians to identify embryos, prior to transfer to the~     uterus, which have the best chance of developing into healthy children. The purpose of this~     study is to validate clinical use of PS to detect specific genetic mutation(s) known to cause~     severe inheritable diseases in embryos produced by at-risk couples. This may be done while~     simultaneously testing these embryos for aneuploidy. This study will allow for first of its~     kind commercial PGS/D testing to detect disease-associated genetic mutations together with~     aneuploidy screening.~   "
194091|NCT01023035|"~     The current trial is designed to prospectively explore the safety of erythropoietin use for~     the treatment of anemia during boceprevir plus peginterferon alfa-2b/Ribavirin (PEG2b/RBV)~     therapy and to assess its relationship to efficacy. All participants in this trial will be~     treated with the triple combination of boceprevir plus PEG2b/RBV. If a participant becomes~     anemic during treatment, the participant will be randomized to one of two therapeutic~     strategies for management of anemia (erythropoietin use versus RBV dose reduction).~   "
194092|NCT01023022|"~     The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in~     clinical practice in the country specific healthcare setting.~   "
194093|NCT01023009|"~     After an uneventfully small gauge vitrectomy we don´t think is necessary to occlude the eye~     for 24 hours~   "
194094|NCT01022996|"~     This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that~     has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after~     gemcitabine- or vinorelbine- or vinblastine-based treatment.~   "
194095|NCT01022983|"~     The purpose of this study is to investigate the safety and efficacy of Levosimendan given~     preoperative to patients with heart failure undergoing noncardiac surgery.~   "
194096|NCT01022970|"~     This study is designed to investigate the effects of a 12 week course of intravenous QAX576~     6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients~     by 75% or greater when compared with baseline.~   "
194097|NCT01022957|"~     to describe evolution of Nephronophthisis~   "
194098|NCT01022944|"~     Rationale: Bacterial biofilms are defined as an assemblage of bacterial cells enclosed in a~     self-produced glycocalyx matrix. Adherence on surfaces, and resistance to both antibiotic~     treatments and host defenses are ones of the major clinical features of bacterial biofilms.~     Hence, biofilm formations represent a serious clinical problem: they persist in human tissues~     and play a role in a large number of chronic and resistant infections. It has been estimated~     that more than 65% of all human bacterial infections involve biofilms. Recently, the~     investigators have demonstrated the presence of mucosal bacterial biofilms in adenoid tissues~     removed during routine adenoidectomy. Bacterial biofilms were visualized using Confocal Laser~     Scanning Microscopy (CLSM) with a technique of double staining showing both the bacterial~     cells and the glycocalyx matrix. Although this study clearly established that adenoids~     tissues can harbour mucosal biofilms, the prevalence of 54% the investigators found suggested~     that some groups of children may contain more biofilm formations than others. In an effort to~     relate the findings of mucosal biofilm with the clinical presentation, the investigators have~     designed the present work to compare the prevalence of mucosal biofilms in adenoidectomy~     specimens in two groups: one group of children with chronic otitis media (COM) with effusion~     versus another group of children without any COM, having adenoids removed for chronic~     obstruction.~   "
194099|NCT01022931|"~     This study aims to identify clinical symptoms and outcomes, as well as response to anti-viral~     treatment in children living in Geneva, with influenza A/ H1N1 infection during the current~     pandemic.~   "
194113|NCT01022749|"~     The primary purpose of the study is to compare the efficacy and safety of influenza vaccine~     in patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapy with~     patients not receiving immunosuppressants .~      The main objective of the study is to evaluate the humoral immunogenicity of influenza~     vaccination in patients with IBD~   "
194213|NCT01021410|"~     The purpose of this study is to better understand the pharmacokinetics of acetaminophen and~     further clinical interpretations of laboratory results that confirm the presence of~     acetaminophen-cys adducts. This study will determine how long adducts persist in serum after~     a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects~     will be asked to complete three study visits, each three days apart, following termination of~     COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing~     of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.~   "
194100|NCT01022918|"~     Treatment of glioblastoma (GBM) is based on surgery when possible, and chemoradiation with~     temozolomide, which became a standard since the EORTC study (Stupp, 2005). However, the~     prognosis of unresectable GBM remains poor despite chemoradiation with an estimated 10 month~     median survival, in the range of the comparable patients in the RPA class V from the EORTC~     study (Miramanoff, 2006).~      Vredenburgh et al. from the Duke University (Durham, NC) reported at ASCO 2006 (fully~     published in J Clin Oncol, 2007) a 57 % unexpected response rate using a~     bevacizumab/irinotecan schedule in patients with relapsed GBM or grade 3 astrocytomas. This~     unusual high response rate, sometimes with major and sustained responses, was confirmed by a~     cooperative french study of ANOCEF (Guiu et al., 2008). Such a major improvement of treatment~     effectiveness lead ANOCEF, which federates most of the active neuro-oncology teams in France,~     to propose a neo-adjuvant and adjuvant bevacizumab-based chemotherapy framing a standard~     temozolomide-based chemoradiation with the aim to improve the prognosis of unresectable GBM.~      The bevacizumab/temozolomide combination as neo-adjuvant is presently being evaluated by the~     Duke University. We believe that an ambitious comparison of the~     bevacizumab/irinotecan-schedule with the ''standard'' temozolomide-based chemoradiation is a~     fascinating challenge to improve the treatment of this awful disease.~      The ANOCEF proposal '' Evaluation of the irinotecan/bevacizumab association as neo-adjuvant~     and adjuvant treatment of chemoradiation with temozolomide for naive unresectable~     glioblastoma. Phase II randomized study with comparison to chemoradiation with temozolomide''~     has been successfully granted by INCA (Institut National du Fancer, France) through its~     research program ( PHRC : Programme Hospitalier de Recherche Clinique). Implementation of~     this program is now starting .~   "
194101|NCT01022905|"~     The objective of this study is to assess vaccine responses to novel adjuvanted influenza~     A(H1N1) vaccines in patients at high risks of influenza A(H1N1) complications.~   "
194102|NCT01022892|"~     The purpose of this study is to support the suspected expectation that Contrast enhanced~     Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT),~     and also find a number of leaks missed by CT.~      The investigators' primary goal is to detect no difference between CT and CUS and provide~     evidence that CUS is a possible alternative to CT.~   "
194103|NCT01022879|"~     The use of topical anesthetics is a non invasive option avoiding local or general anesthesia~     in small gauge vitrectomy without causing intolerable pain~   "
194104|NCT01022866|"~     At the Falls Prevention Clinic, each subject receives a comprehensive assessment of his or~     her individual risk factors for falling in addition to a comprehensive medical examination.~     Recommendations and appropriate followup tests and referrals are ordered for patients on an~     individual basis.~      Essential for medical advancement is the inquiry into information collected from medical~     records of older adults at high risk of falls and fracture. On such example is a~     retrospective chart review we conducted among patients who sustained a hip fracture [14]. The~     database we propose will provide novel insight into the identification of individuals at high~     risk for falls, key predictors of falls and associated mortality, morbidity, health related~     quality of life and healthcare resource utilization. In summary, our database will enable us~     to assess and improve quality of care, service delivery, patient outcomes, patient reported~     outcomes and track economic burden.~   "
194105|NCT01022853|"~     The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD)~     in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in~     patients with advanced or metastatic solid tumours.~   "
194106|NCT01022840|"~     The primary hypothesis is improved postoperative analgetic quality using S-Ketamine,~     particularly in patients suffering from chronic pain.~   "
194107|NCT01022827|"~     The investigators investigated the effect and predictors of effectiveness of massage in the~     treatment of patients with posterior shoulder stiffness. This is a randomized controlled~     trial study- massage and control (hand touch) two times a week for 4 weeks. A total of 60~     patients with posterior shoulder tightness were randomized into 2 groups; 52 of them~     completed this study (29 for the massage and 23 for the control). Patient sex, age, body mass~     index, glenohumeral internal rotation range of motion (ROM), duration of symptom, functional~     status, and muscle stiffness were recorded. Additionally, for the massage group, patients~     with glenohumeral internal rotation improvement of 20 degrees after massage were considered~     responsive, and the others were considered nonresponsive. The influences of the~     aftermentioned factors on the effectiveness of massage were analyzed by multivariate~     logistric regression. The overall mean internal rotation ROM increased significantly after~     massage (from 31.9° to 54.9°; P < 0.001) compared to the control (from 28.7° to 34.9°; P >~     0.05). There were 22 patients in the responsive group and 7 in the nonresponsive group. Among~     the factors, duration of symptoms, FLEX-SF score, and posterior deltoid stiffness were~     significant predictors of effectiveness of massage. Massage was an effective treatment for~     subjects with posterior shoulder stiffness, but was less effective in patients with longer~     duration of symptoms, higher functional limitation, and less posterior deltoid stiffness.~   "
194108|NCT01022814|"~     In the final months of pregnancy, women need to know whether their 'water is broken'~     necessitating a race to the delivery room, or whether pressure of the foetus on their bladder~     has caused them merely to pass urine. They may also have faced the same dilemma on many~     occasions much earlier in the pregnancy. With this development the investigators will provide~     them with an immediate answer to this critical question.~   "
194109|NCT01022801|"~     To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA~     levels by PCR (log10 copies/mL) at Week 22~   "
194110|NCT01022788|"~     This study will develop, implement and evaluate the effectiveness and cost of interventions~     at community level (focussed on a community-based health worker) and of health system~     strengthening on newborn survival in rural southern Tanzania.~      Objectives~        1. To develop and document a community-based package for improved newborn care, focussed~          around interpersonal communication through home visits in pregnancy and the early~          neonatal period .~        2. To develop and document a quality improvement package for antenatal, intrapartum and~          postnatal care in health facilities.~        3. To implement these strategies for improved newborn survival in such a way as to be both~          sustainable and scaleable at national level.~        4. To monitor understanding of, and attitudes related to, neonatal care and survival from~          both health provider and community perspectives in areas with and without the~          interventions.~        5. To measure incremental costs and cost savings to the health sector and society~          associated with the interventions, and to predict the cost of integrating the programme~          into routine health service provision and of scaling-up~        6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to~          improve neonatal survival.~        7. To estimate the effect of the interventions on newborn survival and household behaviours~          related to newborn health.~      Study design & methods. The interventions will be implemented in parts of Lindi and Mtwara~     regions. The health system quality improvement package will be implemented throughout the~     area and evaluated using a before-after comparison. The community intervention will be~     implemented initially in a randomly-chosen half of all wards (a ward is an administrative~     sub-area of a district). Implementation will be led by existing front-line health staff.~     Evaluation will include a health facility survey and a household survey to assess contacts~     with the agents of change, key behaviours and newborn survival in the community.~   "
194111|NCT01022775|"~     The purpose of this study is to determine wether dynamic humeral centering is effective in~     patients with impingement syndrome of the shoulder~   "
194257|NCT01020812|"~     To determine the efficacy and toxicity of TACE combined with SBRT~   "
194114|NCT01022736|"~     This open label investigation is to determine whether cardiopulmonary bypass affects plasma~     gabapentin concentration after preoperative administration in the setting of cardiac bypass~     surgery. Following signed informed consent, 16 patients scheduled for cardiac bypass surgery~     will be given gabapentin (600mg, oral) 1 hour prior to surgery, 1 hour following extubation~     and then every 8 hours for a total of 4 doses. Plasma gabapentin levels will be measured~     prior to induction, prior to bypass, 10 min into the bypass procedure, 10 minutes before~     separation from bypass, 30 minutes following bypass and then before and 2 hours following~     each of the next 3 doses of gabapentin. Pain scores, sedation scores, side effects and~     morphine equivalents will be documented for one day following surgery.~   "
194115|NCT01022723|"~     To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to~     correlate the circulating titre with response and progression.~   "
194116|NCT01022710|"~     This study measures sounds produced by the sensory receptors of the inner ear called hair~     cells. These sounds are called otoacoustic emissions and one special case the investigators~     are studying are called distortion product otoacoustic emissions (DPOAEs) produced by~     presenting two tones to the ear. If the ear is damaged by noise exposure DPOAEs are reduced.~     In this study the investigators are attempting to improve the DPOAE test by adding a third~     tone to make the test more frequency specific. Whether the third tone helps will be~     determined by comparing DPOAEs collected with and without the third tone to clinical~     audiograms. If the addition of the third tone helps then the investigators expect DPOAEs~     tracked as a function of frequency (DP-grams) will more closely match the clinical~     audiograms.~   "
194117|NCT01022697|"~     Fear of full stomach when emergency general anaesthesia is required is the origin of~     fastening when giving birth. This behaviour does not warranty perfect security for the~     general anaesthesia. In addition, well being for women and new born is affected. Giving birth~     is finally compared to a sportive competition with high-energy needs. As Intravenous energy~     intake is not regulated by physiologic digestion, it can induce metabolic disorders for the~     mother that can be amplified for the foetus.~      Oral glucose drinks could offer some benefits:~        -  gastric acidity would be decreased without significant increase in volumes.~        -  energy intake would further more active and more efficiency labour~        -  an increase in foetus well being~      However, it has never been shown yet that such behaviour could offer those benefits. Also, it~     seems that there is not more vomiting, but most of the studies compared oral glucose intake~     to waterborne intake with the same volumes The expected efficacy is a reduction in labour~     duration and a reduction in percentage of extraction. Previous studies said that the lack of~     statistical power due to small number of subjects caused the absence of statistical~     significant relationship.~      In addition, even though newborn have less acidosis, there is no clinical relationship~     proven.~      The investigators propose a randomised multicentre study to assess efficacy of oral glucose~     drinks in comparison to traditional fastening when giving birth.~      Main objective is to significantly reduce instrumental extraction rates. 5400 women will be~     included in the study in 2 years.~   "
194118|NCT01022684|"~     Vascular inflammation is a key factor in both the pathogenesis and outcome of~     atherosclerosis. Various inflammatory markers such as LpPLA2,MCP-2 and hsCRP are well-known~     prognostic factors for the cardiovascular event.~      18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for~     identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore,~     the purpose of the study is to demonstrate the correlation between various inflammatory~     markers and vascular inflammation detected by 18FDG-PET.~   "
194119|NCT01022671|"~     A phase II study is conducted to determine the efficacy and safety of a single agent~     Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small~     cell lung cancer patients previously treated with chemotherapy. The usefulness of the this~     regimen is evaluated by response rate, median survival time, progression free survival and~     duration of response.~   "
194120|NCT01022658|"~     Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of~     cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now~     requiring insulin, to compare the effects of improving glycemic control on these parameters~     with 3 different insulin regimens which will act especially at fasting or in post-prandial~     periods or both. Non invasive explorations will be performed before randomization and after 4~     to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.~   "
194121|NCT01022645|"~     The study is being done in order to gain information on the most suitable types of birth~     control in women who recently had gestational diabetes, or diabetes diagnosed during~     pregnancy. The intrauterine device (IUD) is a highly effective form of birth control. It is~     inserted into the uterus and prevents pregnancy for either 5 or 10 years, depending on the~     type of IUD (hormone-releasing or copper). The hormone-releasing IUD works for 5 years and~     releases a hormone called a progestin into the uterus. The copper IUD contains no hormones~     and works for 10 years. The IUD is an excellent form of birth control postpartum, but it is~     unknown if the hormone-releasing IUD will affect blood sugars and increase a woman's risk of~     becoming diabetic when she's not pregnant. The hypothesis is that the hormone-containing IUD~     will NOT increase blood sugars, so women who use the hormone-containing IUD will have similar~     blood sugars to those who use the copper IUD or have had their tubes tied (no hormones).~   "
194122|NCT01022632|"~     The purpose of this study is to find the effect of commonly used nutraceutical curcumin (~     extract of Curcuma longa, commonly called 'Haldi' in Hindi) in patients of depression.~   "
194123|NCT01022619|"~     The aim of the present study is to establish, using polysomnographic criteria and prospective~     nature, whether sleep apnea in pregnancy is more prevalent in women with high risk~     pregnancies including preeclampsia, gestational diabetes, and pre-mature contractions, and to~     determine the effect of sleep disordered breathing in pregnancy on fetal outcome. The~     investigators' hypothesis is that sleep-disordered breathing is more prevalent in women with~     high risk pregnancy compared to those with uncomplicated pregnancy.~   "
194124|NCT01022606|"~     Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH)~     profile~   "
194125|NCT01022580|"~     The purpose of this study is to determine if late doses of Infasurf surfactant given when~     patients are receiving inhaled nitric oxide will interact to improve surfactant function and~     increase survival without BPD in treated infants.~   "
194126|NCT01022567|"~     Appendicectomy has been the treatment of acute appendicitis for over a hundred years.~     Appendicectomy, however, includes operative and postoperative risks despite being a routine~     operation. At the same time other similar intra-abdominal infections, such as diverticulitis,~     are treated with antibiotics. There have been some encouraging reports on successful~     treatment of appendicitis with antibiotics and it has been estimated that operative treatment~     might be necessary for only 15 - 20 % of patients with acute appendicitis.~      The aim of this randomized prospective study is to compare operative treatment (open~     appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before~     randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of~     the study is that the majority of patients with uncomplicated acute appendicitis can be~     treated successfully with antibiotics and unnecessary appendicectomies can be avoided.~   "
194127|NCT01022541|"~     To evaluate the overall response rate of patients with previously untreated unresectable~     liver-only metastases from colorectal cancer treated with neoadjuvant capecitabine and~     oxaliplatin plus bevacizumab.~   "
194128|NCT01022528|"~     The objective of the study is to examine the effect of the addition of intravenous~     dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid~     consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery~     with laparotomy under general anesthesia.~      This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of~     dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side~     effects.~      Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior~     to placebo in providing post-operative pain control, lower analgesic consumption, prevention~     of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery~     profile. No dose response study has been done. The investigators hypothesize that a higher~     dose of dexamethasone may have an incremental beneficial effect.~   "
194129|NCT01022515|"~     Pheochromocytoma or paraganglioma are tumors generating hypertension as a symptom. Different~     biological tests are currently available to diagnose these tumors. However, they all lack~     specificity since they do not distinguish cases of hypertension without pheochromocytoma or~     paraganglioma. To improve the diagnostic specificity of these tumors, the investigators are~     testing a new marker called EM66.~   "
194130|NCT01022502|"~     To compare the efficacy and safety of refined indigo naturalis ointment with that of crude~     ointment in treating psoriasis.~   "
194131|NCT01022489|"~     Background:~      Repetitive transcranial magnetic stimulation (rTMS) is a recent therapeutic which has~     demonstrated its efficacy in the treatment of auditory hallucinations in patients with~     schizophrenic disorders. Up to now, the target of stimulation has been over the left~     temporoparietal region (based on the international 10-20 EEG system) and rTMS has been~     delivered at low frequency (1 Hz).~      High frequency (20 Hz) might allow shortening the duration of treatment and so could be more~     convenient for the patient (2 days at high frequency instead of 15 days at low frequency).~      Besides high frequency, an accurate target taking into account the inter-subjects anatomical~     variability might increase the efficacy. Based on a great overlap of language and auditory~     hallucinations networks, the investigators hypothesized that targeting the stimulation on the~     highest cluster of activation induced by a language task could be an easier and relevant~     method to determine the target. The investigators suggest that the best area is located at~     the posterior part of the left superior temporal sulcus (STS). Indeed, this area is~     considered as an  epicenter  of language, i.e., involved both in understanding and~     production of language and in the auditory hallucination network. Therefore, the~     investigators conducted an open pilot study in order to test the interest of rTMS at high~     frequency (20 Hz) associated with anatomical and functional magnetic resonance imaging (MRI)~     and neuronavigation in 11 schizophrenic patients with hallucinations. The investigators~     showed a significant reduction of auditory hallucinations; Seven out of 11 patients (63.8%)~     were considered as responders at day 12 with a decrease of more than 30% of the score of~     Hoffman's scale (Auditory Hallucinations Rating Scale) ; 2 patients presented a drastic~     improvement with no hallucinations after 12 days of rTMS. The investigators also showed the~     target based on anatomical and functional MRI was located at the intersection of the left STS~     and the coronal slice across the vertical line of sylvius sulcus.~      The aim of this multicentric double-blind study (randomized and placebo sham) is to~     demonstrate the efficacy of rTMS at high frequency with neuronavigation in the treatment of~     auditory hallucinations in patients with schizophrenia and schizo-affective disorders~     (DSMIV-R).~      Methods:~      72 subjects will be included after written consent. After randomization, the subject will~     receive in a double blind either active treatment or placebo (sham coil) treatment.~      rTMS : 4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity~     of 80% of rest motor threshold will be delivered. These parameters allow the investigators to~     be under the risk of epilepsia, the only one severe side effect. Another mild side effect is~     headache easily treated by antalgic drugs. The target will be established with anatomical MRI~     eventually associated with functional MRI before treatment.~      The efficacy of treatment will be evaluated over 4 weeks (D0, D1, D2, D7, D14, D21 and D30).~     The primary assessment is the percentage of patients who present a decrease of more than 30%~     of the frequency item of Auditory Hallucinations Rating Scale (AHRS) between D1 and D30 at 2~     evaluations spaced of 1 week (Responder patients). The secondary assessments are : 1-~     Relative decrease of frequency item of AHRS between D1 and D14 ; 2- Evolution of total score~     of AHRS at D1, D2, D7, D14, D21 and D30 ; 3- Variation of scores of CGI, SUMD, IS, positive,~     negative, general and total PANSS scores between D0 and D14 and D30 ; 4- Scores at secondary~     side effects (adapted UKU) at D2 and D7; 5- Distances between the present target and the~     classical target based on 10-20 EEG system (T3P3) and/or the target established with~     functional MRI (cluster of activations induced by a listening comprehension task).~   "
194132|NCT01022476|"~     This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of~     Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when~     Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.~   "
194133|NCT01022463|"~     The purpose of this study is to study the effect of Ivabradine vs Atenolol on heart rate and~     effort tolerance in patients with mild to moderate mitral stenosis and normal sinus rhythm.~   "
194134|NCT01022450|"~     1. Analyze the various causes of breakdown of muscle fibers in hospitalized patients.~        2. Analyze the characteristics of these patients in Taiwan (including the drugs history,~          risk factors and the incidence of complications).~   "
194135|NCT01022437|"~     This study is designed to evaluate the effectiveness of geranium oil and its components in~     the relief of numbness and the restoration of sensations.~   "
194136|NCT01022424|"~     ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral~     administration of OPC-41061 at doses of 15 mg twice daily (morning and evening).~     Administration will be continued until the time of manufacturing and distribution approval of~     OPC-41061 for ADPKD in Japan.~   "
194137|NCT01022411|"~     The specific aim of this study is to determine the effects of substituting brown for white~     rice on the treatment of metabolic syndrome (MetS).~   "
194138|NCT01022398|"~     The purpose of this project is to determine if Vitamin D supplementation [10,000~     international units of cholecalciferol (vitamin D3) by mouth weekly] will decrease the rate~     of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of~     muscle ache/pain due to statin therapy.~   "
194139|NCT01022385|"~     The aim of the proposed study is to compare prospectively two methods of small bowel~     preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of~     visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a~     very low residual diet (ENSURE, Abbott Laboratories, Israel) + 12 hour fast.~   "
194140|NCT01022372|"~     Our aim was to evaluate the efficacy of examining endometrial biopsy specimens for nerve~     fibers as a diagnostic test for endometriosis and endometrioma in a double-blind comparison~     with diagnostic laparoscopy.~   "
194141|NCT01022359|"~     This study aims to compare two available types of central venous haemodialysis catheters~     (lines) - CVCs, and will examine how easy they are to insert, complications, blood flow on~     dialysis over time, line loss, line clotting and infective events. It will examine whether~     the LifeCath type of CVC can deliver high blood flow rates from first use after insertion and~     equivalent function and complication rate to the Tesio type of CVC that is in use in our~     centre already. Complications relating to dialysis access make up 30% of admissions for~     haemodialysis patients and so this is a study that could benefit patients and their care~     providers.~   "
194142|NCT01022346|"~     This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety~     and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN~     associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous~     injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be~     made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5~     years.~   "
194187|NCT01021761|"~     Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will~     be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects~     will be instructed to begin dosing the study medication in the operative eye the day before~     surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop~     of study medication will be instilled by operating room staff approximately every 15 minutes~     for a total of 3 doses. At the designated time a paracentesis will be performed at the start~     of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample~     will be immediately stored on dry ice and shipped to a laboratory for analysis.~   "
194143|NCT01022333|"~     Women with a BRCA1 mutation face a lifetime risk of breast cancer of approximately 70% and a~     lifetime risk of ovarian cancer of approximately 40%. A number of potential anti-cancer~     nutrients have been proposed, however, it is important that diet supplements be evaluated~     prior to general recommendation.~      The risk of breast and ovarian cancer in carriers of a BRCA1 mutation might be lowered by~     some nutritional supplements. For example, green tea, broccoli and vitamin D are of potential~     interest. One dietary supplement that is thought to have potential for BRCA1 carriers is~     diindolylmethane (DIM), which is an active ingredient in broccoli and other green vegetables.~     DIM - is found in vegetables like broccoli and is available as a supplement in health food~     stores. The investigators think that DIM may increase the production of the normal copy of~     BRCA1 and offset the effect of the mutation.~      The purpose of this study is to determine that there is a potential for oral DIM~     supplementation to result in the increased production of the BRCA1 protein in BRCA1 mutation~     carriers. The results of the study will also serve as an evaluation of the current use and~     success of preventive strategies for BRCA1 mutation carriers.~   "
194144|NCT01022320|"~     -  Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty~        -  Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic~          and diastolic pressure during daytime and night and changes in the nocturnal decrease.~   "
194145|NCT01022307|"~     The investigators propose to develop quantitative automated lesion detection (QALD)~     procedures to identify brain damage following traumatic brain injury more accurately than is~     possible with a normal magnetic resonance imaging (MRI) scans. These procedures require about~     1 hour of imaging in an MRI scanner. Subjects will also undergo about 2 hours of cognitive~     tests. The investigators will compare the results of the cognitive tests with those from MRI~     scanning to determine what brain regions are responsible for superior performance and for~     performance decrements.~   "
194146|NCT01022294|"~     To assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15~     years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper~     lip~   "
194147|NCT01022281|"~     To compare the Retina Nerve Fiber Layer thickness, measured with Scanning Laser Polarimetry~     in subjects with exfoliation syndrome and normal controls and to evaluate the value of~     scanning laser polarimetry in the early diagnosis and management of exfoliative glaucoma~   "
194148|NCT01022268|"~     This proposal represents a unified programme supported by both clinical and academic staff in~     the Departments of Paediatrics at Imperial College and St Mary's Hospital. St Mary's Hospital~     is the hub of a paediatric network for West London, and forms part of the Paediatric~     Intensive Care Network for the London region, with potential access to a population of 3~     million children.~      We aim to improve diagnosis and understanding of children with infectious, inflammatory and~     allergic conditions. Our study will establish well-characterised cohorts of patients with~     defined conditions, in whom microbiological and patient samples will be used to understand~     the contribution of genetic background, differential gene expression, proteomics and the~     pathogen type to the disease process.~      Unwell children coming to St Mary's hospital through any route will be invited to join the~     study. Entering the study will entail the child having blood taken for research purposes in~     addition to the clinically indicated tests. We will also recruit well (control) children who~     are having blood tests performed for elective purposes, such as surgery.~      In addition, children presenting with an illness that is likely to have an infectious~     aetiology will also have samples collected for microbiological diagnosis. Those samples taken~     for ordinary diagnostic purposes (such as blood, urine, CSF, bronchoalveolar lavage (BAL)~     fluid or nasal brushings for epithelial cell cultures) would also be used for~     state-of-the-art diagnostic techniques, in order to maximise the likelihood of confirming a~     microbiological diagnosis. Where healthy, uninfected children are having invasive procedures,~     such as lumbar punctures, we would aim to recruit these children as controls and collect~     biological samples such as CSF samples.~      This bid addresses the need for translational research in paediatrics, by building on the~     world-class basic science and clinical paediatric base at Imperial College and St Mary's~     Hospital.~   "
194149|NCT01022255|"~     This phase I study will evaluate the safety and tolerability of an autologous idiotype~     vaccine manufactured by magnICON technology for patients with relapsed follicular lymphoma~     who are in complete or partial remission following non-antiCD20 containing salvage therapy.~     Data in terms of idiotype-specific immune responses will also be obtained.~   "
194150|NCT01022242|"~     The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients~     with flexor tendon injury in zone I or II.~   "
194151|NCT01022229|"~     The purpose of this study is to investigate the use of a natural health product, as compared~     to placebo (an inactive substance), in managing the symptoms of ADHD. The natural health~     product contains the nutrients zinc, magnesium, vitamin B6 and vitamin C. Each of these~     nutrients has some evidence to suggest that children with ADHD might be lacking them. As~     such, children with ADHD might benefit from supplementing their diets with these nutrients,~     especially ADHD children who have below average levels.~      This study will measure whether the severity of ADHD symptoms is greater in children with low~     levels of zinc, magnesium, and vitamin B6, and whether the severity of ADHD symptoms will~     decrease with supplementation of these nutrients. This study will also monitor for any~     adverse reactions or side effects from taking these nutrients in children.~      Although these natural health products are commercially available, the use of them as a~     supplement or placebo in this study has been approved for use in this study by the Natural~     Health Products Directorate of Health Canada.~   "
194152|NCT01022216|"~     The purpose of this study is to determine whether a bioelectric wound dressing, used in~     conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of~     diabetic and pressure ulcers of the foot.~   "
194153|NCT01022203|"~     The study is designed to evaluate the efficacy of a novel couple-based treatment for PTSD,~     called Structured Approach Therapy, to decrease PTSD and improve the marital and social~     functioning of Iraqi war Veterans and their partners. The effectiveness of couples therapy~     will be compared with the effectiveness of a couple-based educational intervention.~   "
194154|NCT01022190|"~     The purpose of the study is to determine whether Arcoxia is effective in preventing~     heterotopic ossification after total hip arthroplasty.~   "
194155|NCT01022177|"~     The purpose of this study is to determine the influence of specific eye acupuncture to the~     ocular microcirculation in diabetic and healthy subjects.~   "
194156|NCT01022164|"~     To study the Safety and Efficacy of the use of fibrin glue in vitreoretinal surgery~   "
194188|NCT01021748|"~     This study will investigate the safety and tolerability of combination therapy with MK-2206~     and AZD6244 and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose~     (RPTD) for this drug combination in the treatment of participants with locally advanced or~     metastatic solid tumors. Preliminary efficacy data will also be collected.~   "
194157|NCT01022151|"~     Early postoperative recovery of neurologic and cognitive functions is especially advantageous~     after fast-tracking ambulatory procedures to hasten home discharge after surgery.1 It is well~     known that volatile anaesthetic agents may generate adverse postoperative cognitive effects~     and even traces of it may affect task performance in healthy volunteers.2Hence, rapid~     elimination of the volatile anaesthetics may help reduce postoperative confusion and~     cognitive impairment in surgical patients by facilitating a faster recovery from general~     anaesthesia.3 Sevoflurane has been advocated for the routine anesthesia for ambulatory~     surgery patients. It activates adenosine A1 receptors in primary rat hippocampal cultures~     through the liberation of adenosine secondary to the interaction of with adenosine transport~     or key enzymes in adenosine metabolism.4 However; sevoflurane anaesthesia is associated with~     slower emergence and delayed early postoperative cognitive recovery than desflurane5 and~     xenon2 anaesthesia.~      Aminophylline, which is a hydrophilic cyclic adenosine mono-phosphate (cAMP) dependent~     phosphodiesterase inhibitor has been used for long time to antagonize the sedative effects of~     morphine, diazepam, and barbiturates.6-7Aminophylline in doses of 2-5 mg/kg shortens the~     recovery from sevoflurane anaesthesia and improves bispectral index scores (BIS) with~     concurrent increases in heart rate which might have a detrimental effect in patients with~     ischaemic heart disease.8-11However, the use of smaller doses of 2-3 mg/kg is associated with~     less increases in heart rate. 10-11 The use of 1 mg/kg of Doxapram is comparable to 2 mg/kg~     of aminophylline in improvement of early recovery from sevoflurane anaesthesia secondary to~     its central nervous system stimulating effect rather than increased ventilatory elimination~     of sevoflurane.11 Currently, there is no available published studies have investigated the~     effects of either theophylline or doxapram on early postoperative cognitive recovery after~     balanced anaesthesia with sevoflurane.~      We hypothesized that the use of small doses of aminophylline [2-3 mg/kg] may be comparable to~     larger doses in improvement of the early postoperative cognitive recovery from sevoflurane~     anaesthesia with associated non-significant increases in heart rate.~      The present study investigated the effects of 1 mg/kg of doxapram, and 2, 3, 4, and 5 mg/kg~     of aminophylline on the early postoperative cognitive recovery using the Short Orientation~     Memory Concentration Test (SOMCT), response entropy (RE) state entropy (SE), difference~     between RE and SE (RE-SE), end-tidal sevoflurane concentration, haemodynamics, the times to~     eyes opening and to extubation and degree of sedation after sevoflurane anaesthesia in~     patients undergoing ambulatory surgery.~   "
194158|NCT01022138|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Treating a patient's T~     cells in the laboratory may help the T cells kill more tumor cells when they are put back in~     the body. Giving laboratory-treated T cells after chemotherapy may be an effective treatment~     for breast cancer.~      PURPOSE: This phase II trial is studying how well giving laboratory-treated T cells after~     second-line chemotherapy works in treating women with HER2/neu-negative metastatic breast~     cancer.~   "
194159|NCT01022125|"~     The purpose of this study is to compare the levels of TMC435 in the blood circulation after~     intake of 2 tablet formulations with the level of TMC435 in the blood circulation after~     intake of a capsule formulation. The trial will also evaluate levels of TMC435 in the blood~     circulation after intake of the capsule formulation fasted or following a meal.~   "
194160|NCT01022112|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284~     compared with placebo in patients with type 2 diabetes.~   "
194161|NCT01022099|"~     Evaluation of the component position and kinematics after navigated and conventional Total~     Knee Arthroplasty.~   "
194162|NCT01022086|"~     Herceptin has shown significant improvement in breast cancer therapy and improved survival of~     patients over-expressing the HER-2 protein by 50%. However, Herceptin has shown to negatively~     affect the heart, and frequent heart monitoring with multiple gated acquisition (MUGA) scans~     is required. MUGA scans use radiation and are not very accurate. This study will use cardiac~     magnetic resonance images (CMRs) to evaluate heart function and compare to MUGA scans in~     patients receiving Herceptin for early-stage breast cancer. In addition, novel biomarkers~     will also be assessed at the same time to help identify possible patients at risk for~     developing heart toxicities.~   "
194163|NCT01022073|"~     Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for~     Parkinson's disease~   "
194164|NCT01022060|"~     The purpose of this study is to determine whether Renalof administration promotes partial or~     total dissolution of urinary calculi and improves physicochemical parameters and metabolic~     activity in patients with recurrent calcic urolithiasis. The duration of this double-blind~     placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients~     to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters~     will be assessed every 4 weeks.~   "
194165|NCT01022047|"~     To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by~     means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.~   "
194166|NCT01022034|"~     No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external~     full‐thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that~     recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.~      Method: This is a multicenter randomized non‐inferiority trial. Eligible patients were~     randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal~     surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery~     with mobilization and pexy. Sigmoid resection was not randomized and was added in the~     presence of constipation. The endpoint was recurrence rates defined as presence of external~     FTRP after surgery. A pre‐RCT meta‐analysis suggested a sample size of 251 patients based on~     a 15% expected difference in the 5‐year cumulative recurrence rate. Recurrence‐free curves~     will be generated and compared using the Kaplan‐Meier method and log‐rank test, respectively.~     A Bonferroni adjustment was used. An adjusted p value of <0.01 was considered significant.~   "
194167|NCT01022021|"~     Patients with certain types of cancer require treatment with very high doses of chemotherapy.~     A side effect of high chemotherapy doses is damage to the bone marrow where our blood and~     immune system cells are produced.~      Stem cells (or progenitor cells) are the source of all blood cells. They are formed in the~     bone marrow (the spongy cavity in the center of large bones). The stem cells receive signals~     that direct them to become red cells, white cells or platelets. This happens before they are~     released into the blood stream. Stem cells circulating in the blood stream can be collected~     through a process called apheresis or stem cell collection. The cells are then processed~     and frozen to preserve them. After chemotherapy has been given the stem cells are thawed and~     given back intravenously (IV: into the vein), like a blood transfusion. The stem cells in the~     collection will find their way back into the bone marrow space and, after a few days, will~     start to produce the blood and immune cells as they normally would. Having your own stem~     cells collected and returned to you later is called an autologous transplant.~      Non-Hodgkin's lymphoma is a disease in which malignant cancer cells form in the lymph system.~     Autologous stem cell transplantation is the standard of care for a chemo-sensitive relapse in~     patients with large cell lymphoma that has spread.~      Bendamustine works by blocking the growth of cancer cells. It is used for the management of~     chronic lymphocytic leukemia and follicular lymphoma. Bendamustine in addition to rituximab~     (BR) is used in several trials in patients with lymphoma with encouraging results. Adequate~     peripheral blood stem cell (PBSC) collection is a pre-requisite for high dose therapy~     followed by cell transplantation in patients with relapsed lymphoma. Exposure to previous~     multiple chemotherapy and radiation treatment may lead to poor mobilization of PBSC. It is~     not known whether pre-treatment with bendamustine will adversely affect the process of PBSC~     mobilization and harvest. On the other hand, it is assumed that high dose alkylating agents~     like cyclophosphamide may actually help in breaking the bond between stem cells and the~     stromal cells in the marrow cavity and hence may lead to a better mobilization of PBSC.~   "
194258|NCT01020799|"~     The purpose of this study is to prove the principle that treatment with AZD7268 reduces~     depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.~   "
194168|NCT01022008|"~     Context. Faciocraniosynostoses present with an insufficient growth of the craniofacial~     skeleton due to premature fusion of skull and facial sutures. There are prenatal conditions~     with functional (risk of raised intracranial pressure) and morphological consequences~     (exorbitism, and impairment of upper respiratory airways), the severity of which justifies an~     early surgical treatment based on craniofacial osteotomies and osteodistraction techniques.~      Distraction techniques were started in our unit eleven years ago, and never ceased to be~     modified: Recent improvements allowed better correction of exorbitism and therefore reduction~     of visual risks. But the improvements of the respiratory function remain insufficient. The~     initial evaluations of the respiratory functions were based on blood oxygenation monitoring,~     and showed real improvement. But we have routinely screened our patients with complete~     polysomnography examinations for the past year, and this has always revealed the existence of~     severe sleep apnea syndromes that we fail to correct completely, although there were slightly~     improved.~      The aim of this PHRC protocol is :~        -  the qualitative and quantitative improvement of the respiratory status with a reinforced~          task force group including the specialists in genuine multidisciplinary approach.~        -  A modification of the surgical technique including modifications of the existing~          distraction devices, an increased number of implanted devices, and maybe a change in the~          surgical strategy.~   "
194169|NCT01021995|"~     Extracts produced from Echinacea purpurea are traditionally used for the prevention and the~     acute treatment of influenzal infections like the common cold. The aim of this clinical study~     is to assess clinical safety and efficacy of a treatment with Echinacea in comparison to~     placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year~     will be recruited during October and November 2009 and will be treated with either Echinacea~     or placebo over a period of 4 months.~      Throughout the study period adverse events (AEs) and adverse drug reactions (AEs with at~     least a possible causal relation to the treatment) will be recorded.~      Common cold related symptoms will be recorded in a daily diary.~   "
194170|NCT01021982|"~     Objective perimetry can better monitor visual field defects in RP and Glaucoma patients than~     conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave~     ratio should be significantly higher in areas of visual field defects in RP and Glaucoma~     patients.~   "
194171|NCT01021969|"~     The increasing intake of fructose has been associated with an increase in obesity among US~     children and adolescents, but its dose dependent effects on insulin sensitivity and lipid~     metabolism has not been studied in detail. Methods: 36 healthy male adult human subjects will~     be included in this study. They will be randomly allocated into a low, moderate or high~     fructose, a moderate or high glucose and a sucrose diet for 3 weeks. In randomized order and~     with 4 week wash out intervals each subject will receive all six different diets. Three day~     food records will be used to measure total fructose and glucose intake. During the low~     fructose diet subjects will be instructed to avoid nutrients containing fructose aiming at~     consumption of less than 1g fructose/d. During the moderate fructose diet subjects will~     receive 3x13.3g of fructose or glucose, respectively. High fructose diet subjects will~     receive either 3x26.7g/d of fructose, 3x 26.7g/d of glucose or 3x 26.7g/d of sucrose in the~     form of three daily soft drinks taken together with the three main meals.~      75 g oral glucose tolerance testing will be performed and composite insulin sensitivity index~     will be calculated The presence of phosphorylated fructose metabolites in plasma will be~     measured by targeted LC-MS/MS. In addition, metabolite biomarkers in plasma will be screened~     by untargeted metabolite profiling using both LC-MS and GC-MS. In a subgroup of 10 subjects~     an euglycemic hyperinsulinemic clamp will be performed using [6,6- 2H2]glucose.~      Thus, the lipogenic potential of fructose in humans will be compared with isocaloric amounts~     of glucose. Particularly, the question whether lipogenic effects are continuously dose~     dependent or whether there is a lipogenic shunting and if yes, at what level of ingested~     fructose will be addressed.~   "
194172|NCT01021956|"~     The objectives of this study is to evaluate the safety(first objective) and efficacy(second~     objective)of an experimental drug product,Stakel®, in the treatment of neovascular AMD. The~     drug product is activated in patients by exposure to light at a specific wavelength~     (Vascular Targeted Photodynamic therapy, VTP). The exploratory objective is to assess~     whether it is possible to delay or reduce the requirement for anti VEGF intravitreal therapy~     in the first 12 weeks after VTP.~      All subjects will have a 52 weeks safety follow up telephone call.~   "
194173|NCT01021943|"~     The main objective of this study is to assess the effect of spironolactone on interstitial~     fibrosis in kidney transplant recipients receiving calcineurin inhibitors~   "
194174|NCT01021930|"~     Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis.~     Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI)~     are poor in patients with DM compared with those without DM. Autopsy study has shown delayed~     neointimal healing with inadequate endothelialization and persistent stent surface ﬁbrin~     deposition after DES implantation in DM patients. This might partially contribute to the high~     risk of late stent thrombosis.~      YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with~     micro porous surface. However, limited data is available in vivo about the surface coverage~     after stent implantation in DM patients because of lack of sensitive imaging modalities.~     Optical coherence tomography (OCT) is an optical analogue of intravascular~     ultrasound（IVUS）that allows high-resolution tomographic intravascular imaging. Furthermore,~     several studies have demonstrated the feasibility of OCT to quantitatively evaluate the~     surface coverage and stent conditions in the follow up after PCI .~      Therefore, the aim of this study was to analyze the surface coverage and late malapposition~     after two types of DES implantation in DM patients compared with non-DM patients by using OCT~     and IVUS.~   "
194175|NCT01021917|"~     The overall purpose of this research is to evaluate the long-term outcomes associated with~     participation in Medifast Direct and Take Shape For Life weight-loss programs in comparison~     with non-Medifast weight-loss programs. Another important goal of this research is to~     determine whether the differences between Medifast Direct and Take Shape For Life programs~     affect weight-loss and maintenance of weight-loss in customers.~   "
194189|NCT01021735|"~     That anti-TNF therapy and rituximab therapy are equally effective in treating patients with~     rheumatoid arthritis who meet the eligibility criteria for biologic therapy in the British~     Society for Rheumatology guidelines, and have not previously been exposed to biologic~     therapy.~   "
194176|NCT01021904|"~     In a hospital-based multi-center study in China, HPV 16 was found to be the predominant type~     (72.9%) in cervical cancer, followed by HPV 18(8.0%) which indicated that if the HPV~     prophylactic vaccine are wisely applied in China, about 80% of cervical cancer can be~     prevented.The reported prevalence of HPV in the female population in China was about 13.2%,~     with women in the study between ages 15-55. HPV prevalence peaks in young adults (ages~     20-24:15.5%) and pre-menopausal women (ages 45-49:15%) and this suggests an underestimation~     of cervical cancer burden in China.~      So far, there is no nation wide organized screening program in China, nor is the vaccine~     available for girls innocent to HPV infection. This study aims to vaccinate the daughters~     (aged between 13-15 yrs) living in the selected study areas thus to evaluate how cervical~     cancer and other HPV related diseases can be curbed through primary and secondary~     prevention(in company to screening the mothers aged 35-54 yrs) and to develop a China~     specific model for cervical cancer prevention through HPV vaccination and HPV DNA test~     (careHPV).~   "
194177|NCT01021891|"~     Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up.~     A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at~     Visit 2 for both COPD and non COPD subjects.~   "
194178|NCT01021878|"~     1. LOCATION OF STUDY: Multicentric study in Brazil.~        2. PURPOSE OF THE STUDY: To measure changes in HOMA index when non-diabetic patients in APD~          were exposed to 7,5% Icodextrin for the long-dwell; and to compare such changes with~          those produced by 2,5% glucose for the long-dwell.~        3. PRIMARY OUTCOME: The primary efficacy outcome was to measure HOMA index to set the~          differences with regard to baseline values of this variable for the two groups as well~          as in each group, which showed control of the glucose metabolism.~      STAGE OF THE STUDY : Phase IV postmarket study~      DESIGN: Randomized, open-label, multicenter study. Patients were randomized to receive either~     to Extraneal (7,5% Icodextrin) or 2.5% Dianeal during the long-dwell.~      SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 120 60 ExtranealTM 60 30~     Dianeal® 60 30~      Duration: 1 year.~   "
194179|NCT01021865|"~     The overall goal of this proposal is to determine the effects of acute hyperglycemia and its~     modulation by Glucagon-like Peptide-1 (GLP-1) on myocardial perfusion in type 2 diabetes~     (DM). This study plan utilizes myocardial contrast echocardiography (MCE) to explore a) the~     effects of acute hyperglycemia on myocardial perfusion and coronary flow reserve in~     individuals with and without DM; and b) the effects of GLP-1 on myocardial perfusion and~     coronary flow reserve during euglycemia and hyperglycemia in DM. The investigators will~     recruit individuals with and without DM matched for age, gender and degree of obesity. The~     investigators will measure myocardial perfusion at rest and during vasodilator stress (to~     ascertain coronary flow reserve) while subjects are under controlled pancreatic clamp~     conditions during euglycemia (glucose ~100 mg/dl) and hyperglycemia (glucose ~250 mg/dl) in~     the presence and absence of concomitant GLP-1 infusion. The investigators believe that the~     translational significance of their studies is immense, impacting upon both acute and chronic~     cardiovascular disease manifestations. The effect of glycemic control on cardiovascular~     outcomes, morbidity and mortality remains an area of active investigation, fueled by the~     recent conflicting results of several large clinical trials (ACCORD, United Kingdom~     Prospective Diabetes Study (UKPDS), ADVANCE, VADT). If the investigators find that~     hyperglycemia is associated with altered myocardial perfusion, the mechanistic implications~     in the prevention and management of acute and chronic cardiovascular diseases in DM will be~     groundbreaking. Furthermore, if GLP-1 augments myocardial perfusion (as it does in the~     peripheral vasculature), the therapeutic benefits for prevention of cardiovascular events in~     this predisposed population are clear.~   "
194180|NCT01021852|"~     This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and~     effectiveness of different doses of MK-6096 in the treatment of participants with primary~     insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior~     to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of~     4 weeks of treatment (Week 4).~   "
194181|NCT01021839|"~     The investigators did a randomized control trial comparing bovine carotid artery grafts with~     ePTFE grafts for patients that need hemodialysis access. The goal of the study was to~     determine differences in primary and assisted patency rates and frequency of complications~     between these two types of grafts. The investigators' hypothesis was that bovine carotid~     artery grafts more closely mimic autologous tissue and therefore, would provide better~     patency and fewer complications.~   "
194182|NCT01021826|"~     The purpose of this study is to analyze how common stress hyperglycaemia (abnormally high~     blood glucose) is in primary hip and knee replacement surgeries and which factors predispose~     to hyperglycaemia.~   "
194183|NCT01021813|"~     This study will establish the safety and tolerability of suvorexant (MK-4305) when~     administered for up to 14 months. Participants will be randomized to receive suvorexant or~     placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the~     12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the~     time of initial randomization, participants assigned to receive suvorexant during the initial~     12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either~     suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants~     randomized to receive placebo in the initial 12-month Treatment Phase will continue to~     receive placebo during the 2-month Randomized Discontinuation Phase.~      The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out~     Phase, and will assess rebound and withdrawal.~   "
194184|NCT01021800|"~     Interventional study of modulation of immune response in patients with pancreatic tubular~     adenocarcinoma after resection and gemcitabine treatment. When included, patients are~     pre-treated with moderate doses of cyclophosphamide. Then infusions of allogeneic mononuclear~     cells are given.~   "
194185|NCT01021787|"~     To determine the penetration of micronized and pigmentary TiO2 in Formulas 283419 2 and~     760.001 into the stratum corneum of Compromised (Induced Sunburn) human skin via skin~     stripping of human subjects.~   "
194186|NCT01021774|"~     The purpose of this study is to determine whether the outcome of anal fistula repair with a~     collagen plug is comparable to that of repair by a mucosal advancement flap.~   "
194259|NCT01020786|"~     To investigate efficacy and safety of the combination with pemetrexed plus carboplatin,~     followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer~     (NSCLC) who receive at least one dose of the induction therapy.~   "
194190|NCT01021722|"~     Long-term results after obstetric anal sphincter tears (AST) is poor. The investigators aim~     to improve the long-term outcome after AST in terms of symptoms of anal incontinence.~      A prospective study at, Malmö University Hospital. Twenty-six women with at least grade 3B~     AST were classified and sutured in a systematic way, including separate suturing of the~     internal and external sphincter muscles with monofilament absorbable sutures. The principal~     outcome was a difference in anal incontinence score, based on six questions, between the~     study group and two control groups (women with prior AST [n = 180] and primiparous women~     delivered vaginally without AST [n = 100]).~   "
194191|NCT01021709|"~     Among antidepressant treatments, ECT stands as the most effective in treating acute~     depression. However, patient concerns with the cognitive side effects of ECT have encouraged~     the development of new and more focal forms of brain stimulation such as transcranial Direct~     Current Stimulation (tDCS). Our current study of tDCS as a treatment for depression suggests~     that this technique has antidepressant effects and is safe, painless and well tolerated.~     However, not all patients may respond to this treatment in the way that it is currently~     administered and the concern of possible relapse in some patients who respond to tDCS has~     raised interest in finding alternative, possibly more optimal ways of administering tDCS.~     This study will investigate whether using alternative electrode montages can improve the~     antidepressant effects of tDCS in people suffering from depression.~   "
194192|NCT01021696|"~     In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural~     disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those~     with severe dementia. Since older persons with dementia have less communicative skills,~     suffer from more pain and exhibit more agitation, pain may be a contributing factor in these~     patients. More than 40% of patients with BPSD are treated with neuroleptics despite described~     side-effects. There is an urgent need to investigate the impact of individual pain management~     on BPSD in patients with dementia.~      It was hypothesized that~        -  pain increase BPSD in patients with dementia~        -  individual pain treatment decrease BPSD in patients with dementia~   "
194193|NCT01021683|"~     The purpose of this observational study is to investigate whether a sufficient concentration~     of itraconazole can influence disappearance of a fever (defeverscence) when intravenous (into~     the vein) itraconazole is administered for resolving unknown neutropenic fever of~     participants who are given itraconazole oral solution as a prophylaxis under general~     treatment conditions.~   "
194194|NCT01021670|"~     The purpose of the study is to collect information regarding the safety of dapoxetine~     hydrochloride when used in clinical practice to treat men with premature ejaculation.~     Dapoxetine hydrochloride is a selective inhibitor of serotonin reuptake that is indicated for~     the treatment of patients with premature ejaculation.~   "
194195|NCT01021657|"~     The purpose of this study is to provide data on the lipid profile of the Tenon's capsule in~     Human glaucomatous eyes and to establish possible relationships with the short term outcome~     of filtration surgery.~   "
194196|NCT01021644|"~     The primary purpose of this pilot study is to determine whether African Americans with mild~     Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training~     study.~   "
194197|NCT01021631|"~     Blood transfusion is related to worse outcomes and the triggers for red blood cells~     transfusion are not well defined in cardiac surgery. Retrospective studies in cardiac surgery~     do not show benefits of red blood cell transfusion in reduction of morbidity and mortality in~     cardiac surgery. There are no prospective studies comparing outcomes between restrictive or~     liberal strategy in cardiac surgery.This study is a double-blind randomized study comparing~     clinical outcomes between two strategies of transfusion in cardiac surgery - liberal or~     restrictive.~   "
194198|NCT01021618|"~     Not infrequently, a physician is faced with uncertainty regarding the ability of a patient to~     perform adequate exercise in the noninvasive evaluation of known or suspected coronary artery~     disease (CAD) by the use of radionuclide stress myocardial perfusion imaging. In selected~     patients, protocols that combine exercise (either low-level or symptom-limited) with~     vasodilator stress agents have been found to be safe and effective in both identification of~     the presence and severity of CAD as well as risk stratification for adverse cardiac outcome.~     However, currently utilized combined stress protocols have drawbacks. Further refinement of~     combined stress protocols would potentially lead to more appropriate stress protocol~     selection for patients while enhancing laboratory efficiency. The purpose of this~     prospective, randomized study will be to evaluate the relative merits of combining~     regadenoson with symptom-limited exercise in patients clinically-referred for~     vasodilator-exercise stress myocardial perfusion imaging for the assessment of known or~     suspected CAD. It is hypothesized that combining regadenoson with symptom-limited exercise is~     a safe and feasible stress testing modality which is non-inferior to that which combines~     symptom-limited exercise with dipyridamole.~   "
194199|NCT01021592|"~     This observational study will observe the degree of the quality of life in patients with~     multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European~     Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and~     EQ-5D (EuroQol-5 Dimensions). Both tools are validated research instruments used to measure~     the quality of life in cancer patients and consequently will provide fundamental data~     regarding the quality of life in patients with multiple myeloma by analyzing factors that~     affect the quality of life.~   "
194212|NCT01021423|"~     A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of~     first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not~     candidates for transplantation and have achieved partial response (PR) or complete response~     (CR).~      This study was prematurely terminated by the sponsor in light of new unpublished data that~     rendered the current design of the study no longer clinically relevant. A study design with~     the control arm of no active treatment was no longer appropriate. The termination of the~     trial was not based on any safety concerns in the study.~   "
194214|NCT01021397|"~     Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children~     under 5 years of age, causing serious respiratory tract disease. The primary purpose of this~     study is to test the safety of and immune response to a new HPIV vaccine in healthy infants~     and children.~   "
194296|NCT01020253|"~     The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective~     on prosthetic or lumbar spine BMD after total hip arthroplasty.~   "
194200|NCT01021579|"~     Polycystic ovary syndrome (PCOS) is a common endocrinopathy affecting 6.5%-6.7% of women in~     reproductive age, and is commonly associated with obesity, menstrual irregularity, insulin~     resistance (IR), infertility, and clinical hyperandrogenism and/or hyperandrogenemia (1,2).~     PCOS is also associated with increased risk of abnormal lipoproteins and hypertension, as~     well as cardiovascular or cerebrovascular morbidity (3). The lipid and lipoprotein profile in~     androgenized women with poly cystic ovaries is similar to the made pattern with higher levels~     of cholesterol, low-density lipoprotein (LDL), and lower levels of high-density lipoprotein~     (HDL), and this abnormal pattern is independent of body weight (4). Insulin resistance is~     associated with reproductive abnormalities in women with PCOS. Improving insulin sensitivity~     through both lifestyle and pharmacological intervention can ameliorate these abnormalities.~     Insulin resistance in women with PCOS is common (up to 50%), both in obese and nonobese women~     (5), and disordered insulin action precedes the increase in androgen.~      Treatment for PCOS subjects typically includes, implementation of lifestyle changes~     especially weight loss and adjuvant pharmaceutical intervention including oral~     contraceptives, anti-androgen therapy and insulin-lowering drugs (such as, metformin) (6).~     Metformin is a biguanide used extensively in type 2 diabetes. It inhibits hepatic glucose~     production and increases peripheral insulin sensitivity, but dose not cause hypoglycemia.~     Several studies have shown an increase in insulin sensitivity and pregnancy rate accompanied~     by decreased insulin and androgen levels in PCOS patients taking metformin (7).~      The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-COA) reductase inhibitors (statins) are the~     rate-limiting step in cholesterol biosynthesis, and inhibition of this enzyme decreases~     cholesterol synthesis and a compensatory increase in the expression of LDL receptors in the~     liver. Statins reduce plasma triglycerides in dose-dependent fashion and also have a modest~     HDL-raising effect which is not dose-dependent (8,9). Furthermore, statins pose other~     cardio-protective properties, including antioxidant and anti-inflammatory actions (10,11).~      Some studies have reported that simvastatin decreases serum androgen levels in women with~     PCOS (12,13) by inhibiting proliferation and steroidogenesis of ovarian theca-interstitial~     cells (14). According to these previous findings, we hypothesized that combination therapy~     with simvastatin and metformin will result in lower androgen levels and cardiovascular risk~     factors in women with PCOS.~   "
194201|NCT01021566|"~     The purpose of this study is to determine whether combined hemoperfusion-hemodialysis~     treatment is an alternative drug-free, effective, and safe treatment for opiate~     detoxification.~   "
194202|NCT01021553|"~     To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior~     efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an~     8 week study period compared to placebo in men with primary premature ejaculation. An~     assessment of the safety and tolerability of all doses of GSK557296 will be performed as well~     as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at~     the end of the 8 weeks of treatment. During the active treatment period study participants~     will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both~     4 week intervals.~   "
194203|NCT01021540|"~     To determine if H.P. Acthar Gel (repository corticotrophin) has the same anti-proteinuric~     effects seen with the synthetic ACTH analogue in Europe.~   "
194204|NCT01021527|"~     A four-period study to evaluate if the grade glucose infusion procedure will be able to~     detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment~     in healthy subjects.~   "
194205|NCT01021514|"~     Arteriosclerosis is a dynamic inflammatory disorder. Recently, FDG-PET CT is emerging~     diagnostic tool of non-invasive technique to detect vulnerable atherosclerotic plaque. And~     there are arising evidence that sRAGE(soluble Receptor for Advanced glycation End Product) is~     correlated with metabolic risk. So the investigators will investigate association between~     sRAGE and FDG-PET uptake in large artery in healthy patient.~   "
194206|NCT01021501|"~     This is a prospective, open, non-randomized, non-controlled study. 20 patients with~     hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients~     had mild to moderate hypertension and are receiving antihypertensive agents.~      This study was designed to investigate effects of Adalat GITS on hemodialytic blood pressures~     in patients with chronic hemodialysis by using ABPM and measuring the drug plasma~     concentrations. For the purpose of investigating the influence of hemodialysis on the drug~     plasma concentration as well as its efficacy, it should be necessary to assign the subjects~     with the Adalat monotherapy. Since most patients in the hemodialysis center will be those who~     need and already receive combination therapy, it would be practical to start Adalat 60mg/day~     monotherapy to remain similar antihypertensive effect when discontinuing the previous~     treatment in this study population to be screened and enrolled. And taking into the~     consideration of clinical practice, few patients undergoing hemodialysis could be well~     controlled by low dose Adalat 30mg/day alone. So this study will evaluate the effect and~     safety of Adalat GITS 60mg/day alone and thereafter the influence of hemodialysis on the drug~     plasma concentration without any other possible drug interaction. The agents are given orally~     once a day at 08:00h and patients are followed for at least 4 weeks. After that,the patients~     whose blood pressure are well controlled by Adalat GITS 60mg/day by office blood pressure~     would be enrolled for further ABPM assessment and plasma concentration evaluation.~   "
194207|NCT01021488|"~     Deep vein thrombosis (DVT)is devastating disease which influencing the mortality and~     morbidity of patients at-risk like those undergoing orthopedic surgery.~      Recent publication suggested HMO-co-A reductase inhibitor (statin) may reduce the occurrence~     rate of venous thromboembolism in apparently healthy persons.~      The pleiotropic property of statin like antioxidant, antithrombotic, anti-inflammatory may~     have effect on the positive results.~      We are investigating whether rosuvastatin is associated with lower incidence of deep vein~     thrombosis (DVT) in patients undergoing total knee replacement arthroplasty(TKRA)who are~     at-high risk for developing DVT~   "
194208|NCT01021475|"~     The goal of this study is to determine if Visceral Manipulation (VM) is effective in treating~     Functional Dyspepsia in addition to drug therapy.~      Null hypothesis is that VM does not influence FD symptoms.~   "
194209|NCT01021462|"~     A two period pilot study to determine if a graded glucose infusion using a glucose (20%~     dextrose [D20]) intravenous infusion can be properly implemented and will be well tolerated~     in healthy subjects.~   "
194210|NCT01021449|"~     In this proposal, we will (1) detect the associations between BDNF and Trk B gene DNA~     methylation, histone modification, psychotic symptoms, obesity, suicide and antipsychotic~     drug responses in Taiwanese patients (2) discuss the possible mechanisms of epigenetic~     regulation of BDNF and Trk B in schizophrenia patients.~   "
194211|NCT01021436|"~     This study is to understand how the inhaled form of amikacin is spread throughout the human~     body and how it is eliminated from the body and to make sure that giving an inhaled form of~     Amikacin to patients is safe and well tolerated~   "
194230|NCT01021163|"~     The purpose of this study is to study the effects of N-acetylcysteine on pulmonary function~     in high-risk patients undergoing off-pump coronary bypass surgery.~   "
194297|NCT01020240|"~     The purpose of this study is to promote a prevention of the complications using an elaborate~     guide effective and easy to understand.~   "
194215|NCT01021384|"~     The objective of this 2 year research project is to determine whether an evidenced-based~     empowerment strategy, Problem Solving Education (PSE), targeted to mothers of young children~     with autism spectrum disorders (ASDs), promotes family well-being by decreasing the burden of~     maternal depressive symptoms and maternal parenting stress and improving social functioning.~     We propose a randomized control trial involving 140 mothers who have children <4 years with~     confirmed ASDs. Based on the paradigm of the IOM report on mental health prevention research~     that highlights the importance of targeting interventions to at-risk populations who may not~     meet diagnostic criteria, all mothers of young children with ASDs will be eligible to~     participate. Consistent with previous studies of cognitive-behavioral interventions, the~     mother-child pairs will be followed for 9 months. The intervention will be embedded in two~     settings that provide services to young children with ASDs - Early Intervention (EI) programs~     and specialty developmental assessment clinics. We aim to support families during a critical~     juncture - when they are confronted with a new diagnosis and are asked to navigate a complex~     service system on their children's behalf. The hypothesis of this proposal is that~     strengthening problem solving skills among mothers of young children with ASDs serve as an~     important buffer against the negative impact of life stressors, and thereby prevent and~     attenuate depressive symptoms and parenting stress.~   "
194216|NCT01021371|"~     The aim of this study is to investigate the impact of a joint effort towards intensifying the~     collaboration and communication between hospital and general practice.~   "
194217|NCT01021358|"~     This is a single dose, open-label, single or multiple center study to determine the~     interaction of ketoconazole with ABT-263 in approximately 12 subjects with cancer.~   "
194218|NCT01021332|"~     Clinical study to examine the safety, tolerability and efficacy of long-term combination~     therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract~     symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage~     component.~   "
194219|NCT01021319|"~     The aim of the study is to evaluate the use of combined fluid attenuated inversion recovery~     (FLAIR) imaging and diffusion weighted imaging (DWI) as surrogate marker of lesion age within~     the first 6 hours of ischemic stroke in order to identify patients ≤ 3 or ≤ 4.5 hours of~     symptom onset in a large multicenter study hours of ischemic stroke. The investigators~     hypothesize that the pattern of a visible lesion on DWI together with a negative FLAIR~     (DWI-FLAIR mismatch) will identify patients ≤ 3 hours of symptom onset with >80%~     specificity and positive predictive value.~   "
194220|NCT01021306|"~     At any given time, 10 million Americans suffer from temporomandibular disorders (TMD), with a~     lifetime prevalence of 45% and costs for direct care exceeding $2 billion/year. Little~     evidence exists regarding the efficacy of specific conservative interventions used to treat~     TMD and currently there is no gold standard of care that is widely accepted by the dental~     or medical community. This study is a prospective, randomized 4 arm parallel observer-masked~     pilot study comparing: 1) Activator Methods Chiropractic Technique (AMCT), 2) a conservative~     dental approach with reversible interocclusal splint therapy, 3) a sham AMCT, and 4) a~     self-care only group, which includes a standard checklist of self-care jaw relaxation~     techniques, for a total of 80 patients with chronic myofascial TMD.~   "
194221|NCT01021293|"~     The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when~     administered to healthy Chinese infants at 2, 3 and 4 months of age.~   "
194222|NCT01021280|"~     Parathyroid hormone (PTH) gland calcium sensing receptor (CASR) regulates PTH secretion. CASR~     is also expressed in nephron thick ascending limb (TAL). Bartter syndrome (BS), a~     normotensive hypokalemic tubulopathy, may be due to mutations in different TAL channels,~     including the potassium channel ROMK. Mutations in CASR may also cause BS through its effects~     on ROMK function. However, it is unknown whether ROMK mutations exert any effects on CASR~     function and PTH physiology. Preliminary data from our center shows that PTH levels were~     specifically elevated in type II (where ROMK is mutated) and not in type IV (where another~     gene, Barttin is defective) BS, without a common explanation. We assume that the mutation in~     ROMK may cause a dysregulation of PTH secretion via possible interaction with CASR.~      The purpose of this study is: to investigate the PT-gland function and regulation in BS.~      Methods: Patients with BS type II and IV and normal controls will undergo a standard protocol~     of controlled ionic hypo- and hypercalcemia, during which PTH secretion, phosphate balance~     and calcium excretion will be followed. Calcium Vs PTH response curves will be generated and~     compared.~      Expected impact and benefit: the results of this study will help understand the mechanisms of~     PTH regulation beyond CASR.~   "
194223|NCT01021267|"~     Assessment in an open trial if a standardized saw palmetto preparation has a positive~     influence on sexual dysfunctions in patients with BPH and sexual dysfunctions.~   "
194224|NCT01021241|"~     The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of~     single intravenous doses of Uricase-PEG 20.~   "
194225|NCT01021228|"~     The purpose of this study is to compare the impact and outcome of continuous volatile~     anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in~     liver surgery.~   "
194226|NCT01021215|"~     The goal of this clinical research study is to learn how zileuton alone or the combination of~     zileuton and celecoxib may affect certain chemicals in the body that may be linked with a~     risk for smoking-related lung disease. These effects will be measured by a urine test~   "
194227|NCT01021202|"~     The purpose of this study is:~        -  to evaluate the optimal time-point for percutaneous dilation tracheostomy in COPD~          patients in terms of duration on mechanical ventilation, length of stay on ICU and~          mortality;~        -  to evaluate the rate of infections and infectious complications of tracheostomized COPD~          patients;~        -  to evaluate the spectrum of pathogens in tracheostomized and intubated COPD patients;~        -  to evaluate the amount of sedatives used in mechanically ventilated COPD patients;~        -  to assess the quality of life in COPD patients tracheostomized after 3 or after 10 days.~   "
194228|NCT01021189|"~     The primary aim of this study is to assess the safety and tolerability of AZD1446 following~     single and multiple ascending doses of an orally administered solution of AZD1446 in healthy~     young and elderly Japanese subjects.~   "
194229|NCT01021176|"~     The purpose of this study is to determine whether the blood pressure medication, diltiazem,~     will temporarily decrease the sense of smell when given in a nasal spray which will then~     reduce food intake.~   "
194231|NCT01021150|"~     Primary Objective:~        -  To determine the maximum tolerated dose based on the incidence of dose limiting toxicity~          and the maximum administered dose of ombrabulin in combination with cisplatin~          administered every 3 weeks in patients with advanced solid tumors.~      Secondary Objectives:~        -  To assess the overall safety profile of the combination therapy.~        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR~          258063, and cisplatin in combination.~        -  To evaluate anti-tumor activity of the combination therapy.~   "
194232|NCT01021137|"~     The purpose of this project is to determine the effects of mild traumatic brain injury and~     blast exposure on the inner ear balance and central nervous systems.~   "
194233|NCT01021124|"~     The aim of this study is to estimate the usefulness of a T cell-based assay (i.e.~     Quantiferon-Gold In-Tube assay) for diagnosis of latent tuberculosis infection (LTBI) in bone~     marrow transplant recipients. For this purpose, the investigators enrolled bone marrow~     transplant recipients and observed the developement of tuberculosis after the~     transplantation.~   "
194234|NCT01021111|"~     The overall goal of this project is to reduce the risk for anterior cruciate ligament~     injuries by designing a targeted intervention that will alter the known kinematic and kinetic~     risk factors associated with ACL injuries.~   "
194235|NCT01021098|"~     Recently, the emergence and rapid global dissemination of novel swine-origin influenza A~     virus (H1N1) with unique epidemiologic characteristics has heightened awareness and concern~     of this viral pathogen, and its potential for major disruption of both civil and military~     stability. Although advances in medical and scientific technologies have improved our basic~     understanding of respiratory disease, many questions about the epidemiology and immunology of~     ARI remain unanswered. This study plans to initiate a multi-site, multi-disciplinary research~     collaboration, termed the Acute Respiratory Infection Consortium (ARIC) for the purpose of~     studying the etiology, epidemiology and immunology of influenza-like illness (ILI) in order~     to describe the natural history and risk factors for disease, as well as the characteristics~     of the host immune response.~      At the core of the ARIC is the proposed observational, longitudinal study of the Natural~     History Study of ILI among active duty military members, healthy retirees, and their~     dependents recruited from both inpatient and outpatient settings of military treatment~     facilities (MTF) in the continental US to be followed for a total of four (4) visits over a~     28-day period. Additionally, the investigators also propose to conduct a household-based~     study of influenza (Family Transmission Study) in which individuals who have a~     laboratory-confirmed influenza illness will be recruited and enrolled along with their family~     members for the purpose of studying transmission of influenza within households. Taken~     together, these studies will establish a longitudinal cohort of ILI among active duty members~     and their families, as well as a repository of biological specimens relevant to the~     epidemiology and immunology of infection. Ultimately, these studies will serve as a solid~     foundation on which future investigations of ARI epidemiology, treatment and prevention can~     be based.~   "
194236|NCT01021085|"~     Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56~     days as confirmed by artificial reproductive technology (ART). The samples will be used to~     develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal~     plasma or urine.~   "
194237|NCT01021072|"~     The purpose of this study is to block interleukin-1 alpha activity with a True Human~     monoclonal antibody, thus interrupting the inflammatory response that supports tumor~     growth/metastasis and which drives the cachexic process.~      An adaptive design will be employed which will allow for the exploration of different dosing~     regimens, as well as tumor types that show preliminary evidence of efficacy.~   "
194238|NCT01021059|"~     Background:~        -  Recombinant human interleukin-15 (rhIL-15) is a substance that is naturally produced in~          the body that has many properties that increase the activity and strength of the immune~          system, the body s natural defense system. It is hoped that rhIL-15 can boost or~          strengthen patients immune systems and restore immune responses against cancer and~          infectious diseases like HIV.~        -  rhIL-15 is being studied in patients with malignant melanoma, an aggressive type of skin~          cancer, and in patients with renal cell carcinoma, a type of kidney cancer that has~          spread to other parts of the body. Researchers are interested in determining if rhIL-15~          can help stimulate the immune system and aid in the treatment process for cancers that~          have not responded well to standard therapies.~      Objectives:~        -  To determine whether rhIL-15 is safe and effective in the treatment of metastatic~          malignant melanoma or metastatic renal cell carcinoma~        -  To examine how the body processes rhIL-15 after each infusion and determine how it acts~          on the treated cancer.~      Eligibility:~        -  Patients older than 18 years of age that have been diagnosed with metastatic malignant~          melanoma or metastatic renal cell carcinoma that has not responded to standard~          treatments.~        -  Eligible patients may not have received prior treatment with interleukin-2.~      Design:~        -  Prior to treatment, patients will have baseline blood tests and imaging scans.~        -  Participants will be admitted to an in-patient unit of the NIH Clinical Center for this~          treatment. rhIL-15 will be given intravenously once a day for 12 consecutive days, for a~          total of twelve doses of the drug. The injection of rhIL-15 will take about 30 minutes.~          Patients will be evaluated daily before each treatment and more frequently if necessary.~        -  During the 12-day treatment and for at least 42 days from the start of the treatment,~          patients will be closely followed for possible side effects and for tumor response.~          Blood will be drawn frequently for monitoring purposes, and other procedures such as~          chest x-rays and imaging scans will be performed to monitor the state of the tumor and~          the patient response to treatment.~        -  After completing the rhIL-15 treatment and discharge from the hospital, patients will~          have an evaluation with a member of the research team once a week from the end of the~          treatment period to 42 days from the start of the treatment.~        -  Study doctors may ask patients to return for evaluation (including blood draws) at 3 and~          6 months after the completion of the treatment, checking for potential long-term effects~          or toxicity of the treatment.~      Background:~        -  Recombinant human interleukin-15 (rhIL-15) is a substance that is naturally produced in~          the body that has many properties that increase the activity and strength of the immune~          system, the body s natural defense system. It is hoped that rhIL-15 can boost or~          strengthen patients immune systems and restore immune responses against cancer and~          infectious diseases like HIV.~        -  rhIL-15 is being studied in patients with malignant melanoma, an aggressive type of skin~          cancer, and in patients with renal cell carcinoma, a type of kidney cancer that has~          spread to other parts of the body. Researchers are interested in determining if rhIL-15~          can help stimulate the immune system and aid in the treatment process for cancers that~          have not responded well to standard therapies.~      Objectives:~        -  To determine whether rhIL-15 is safe and effective in the treatment of metastatic~          malignant melanoma or metastatic renal cell carcinoma~        -  To examine how the body processes rhIL-15 after each infusion and determine how it acts~          on the treated cancer.~      Eligibility:~        -  Patients older than 18 years of age that have been diagnosed with metastatic malignant~          melanoma or metastatic renal cell carcinoma that has not responded to standard~          treatments.~        -  Eligible patients may not have received prior treatment with interleukin-2.~      Design:~        -  Prior to treatment, patients will have baseline blood tests and imaging scans.~        -  Participants will be admitted to an in-patient unit of the NIH Clinical Center for this~          treatment. rhIL-15 will be given intravenously once a day for 12 consecutive days, for a~          total of twelve doses of the drug. The injection of rhIL-15 will take about 30 minutes.~          Patients will be evaluated daily before each treatment and more frequently if necessary.~        -  During the 12-day treatment and for at least 42 days from the start of the treatment,~          patients will be closely followed for possible side effects and for tumor response.~          Blood will be drawn frequently for monitoring purposes, and other procedures such as~          chest x-rays and imaging scans will be performed to monitor the state of the tumor and~          the patient response to treatment.~        -  After completi...~   "
194239|NCT01021046|"~     The purpose of this study is to study whether deep anterior lamellar keratoplasty (DALK)~     using acellular tissue will promote corneal graft survival in high risk patients.~   "
194240|NCT01021033|"~     Background:~        -  Stroke, also known as acute cerebrovascular attack, is the leading cause of long-term~          disability worldwide. Stroke survivors are often left with permanent physical and mental~          disabilities.~        -  Many stroke patients receive different therapies in an attempt to improve their~          independence and quality of life. However, current strategies are focused on the acute~          stage after stroke and are of limited influence in improving stroke outcome. One of the~          main problems of patients who have suffered a stroke is the difficulty in using the hand~          on the opposite side of the affected hemisphere of the brain; to date, researchers have~          no successful means to improve the hand function in chronic stages of stroke.~        -  Researchers are interested in developing a pool of individuals for further research into~          hand and motor function after a stroke.~      Objectives:~      - To perform a screening evaluation of patients referred with stroke to determine their~     eligibility for current and future protocols studying the effects of stroke on the nervous~     system and motor function.~      Eligibility:~      - Individuals who have experienced a single stroke on only one side of the brain that~     occurred at least 3 months prior to participation in the screening study. Individuals must~     have some residual hand motor function.~      Design:~        -  Participants in this study will be recruited from patient referrals.~        -  Eligible participants will undergo a 4- to 5-hour screening with a medical history,~          physical and neurological examination, stroke evaluation, and an anatomical magnetic~          resonance imaging (MRI) of the brain. The screening visit may be done over the course of~          more than one day, if needed for patient convenience or test availability.~        -  In addition to the initial outpatient visit, subjects may remain enrolled in this study~          for up to 15 years and may be contacted to see if they qualify for new branch studies.~          Subjects may be re-examined up to once per year while they remain in this protocol to~          confirm ongoing eligibility. The re-examination visits will involve a neurologic~          evaluation and possible repeat MRI.~        -  No clinical care will be provided under this protocol..~   "
194241|NCT01021020|"~     This randomized, single dose, three-way crossover study will evaluate the bioequivalence of~     two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed~     combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting~     conditions. It will also determine the bioavailability following a standard high-fat meal and~     evaluate the safety and tolerability of the test product.~   "
194242|NCT01021007|"~     Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation~   "
194244|NCT01020981|"~     This project will add an evaluation/research component to an existing peer outreach program,~     now implemented for over 1100 soldiers in the Michigan Army National Guard. Preliminary work~     will be completed in three areas. We will conduct semi-structured interviews with soldiers,~     Buddies, and National Guard leadership and develop and pilot test survey items relevant to~     implementation. Further, we will develop and pretest survey items relevant to determining~     soldier symptomatic and functional status. We will also conduct a small feasibility study,~     fielding the newly developed survey to a representative sample of recently returned National~     Guard members from Michigan and Indiana, to determine response rates and veteran willingness~     to allow access to linkable PDHA/PDHRA data and health services data. Finally, we will~     construct a merged, de-identified longitudinal dataset comprised of Post-Deployment Health~     Assessment and Reassessment data, Military Health System/TRICARE, and VA services data from~     National Guard soldiers in Michigan and comparison states of Indiana and Ohio. This will~     allow a longitudinal assessment of services initiation and retention for the entire Guard~     populations in these states.~   "
194245|NCT01020968|"~     This study is designed to assess the safety profile and the efficacy of cardiac repair cells~     (CRCs) administered via catheter in treating patients with dilated cardiomyopathy (DCM).~   "
194246|NCT01020955|"~     The aim of this study is to measure effects of the combined treatment with GH and IGF-I on~     glucose sensitivity and body composition in patients with GHD and IGT or diabetes.~   "
194247|NCT01020942|"~     Myocyte necrosis as a result of elective percutaneous coronary intervention (PCI) occurs in~     approximately one third of cases and is associated with subsequent cardiovascular events.~     This study assesses the ability of electroacupuncture (EA) pretreatment to attenuate cardiac~     troponin I (cTnI) release after elective PCI.~   "
194248|NCT01020929|"~     The investigator hopes to learn the incidence of needle placement in both the epidural and~     intravascular space, and learn mixed epidural-intravascular pattern related to needle type,~     gauge, and level of injection. We also hope to evaluate the length of fluoroscopy time when~     using real time fluoroscopy during contrast dye injection, evaluate the radiation exposure to~     the hands of the physician during this protocol, and confirm the incidence fo intravascular~     injection and sensitivity of needle flash of blood, In the lumbar spine, vascular contrast~     patterns are more than twice as likely to appear simultaneous to the anticipated epidural~     pattern, than they are to occur alone. This is important since practitioners are more likely~     to miss a vascular pattern that occurs simultaneous to epidural spread, than they are to~     occur alone. The incidence of intravascular penetration in cervical transforaminal epidural~     injections is known to exceed that of lumbar injections, however no study has determined the~     incidence of simultaneous epidural and vascular injection in the cervical spine. This study~     may prove that real time fluoroscopy during contrast injection is warranted to prevent~     intravascular injection and resultant side effects to support this as standard of care.~      Intermittent fluoroscopy can yield false-negative results for intravascular injection when~     simultaneous epidural and intravascular injection occurs. This could lead to an increased~     risk of complication from intravascular injection of medications and reduce overall efficacy.~     No studies to date have quantified the incidence of needle placement located in both the~     intravascular space and epidural space simultaneously.~   "
194249|NCT01020916|"~     Experimental studies and previous clinical trials suggest an improvement in mortality and~     neurological function with hypothermia after cardiac arrest. However, the accrued evidence is~     inconclusive and associated with risks of systematic error, design error and random error.~     Elevated body temperature after cardiac arrest is associated with a worse outcome. Previous~     trials did not treat elevated body temperature in the control groups. The optimal target~     temperature for post-resuscitation care is not known. The primary purpose with the TTM-trial~     is to evaluate if there are differences in all-cause mortality, neurological function and~     adverse events between a target temperature management at 33°C and 36°C for 24 hours~     following return of spontaneous circulation after cardiac arrest.~   "
194250|NCT01020903|"~     Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and~     vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize~     this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of~     post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive~     decadron and ondansetron. Half the patients will receive aprepitant in addition. The other~     half will receive placebo. The study will be randomized and double-blind.~   "
194251|NCT01020890|"~     The purpose of this study is to provide data on the gastroesophageal reflux disease (GERD)~     prevalence as percentage of patients with upper gastrointestinal (GI) symptoms that are~     identified with GERD using the Gerd-Q Questionnaire.~   "
194252|NCT01020877|"~     The primary object of this study was to evaluate the relative bioavailability of the test~     formulation of metronidazole vaginal gel with the already marketed reference formulation~     MetroGel-Vaginal Gel® in healthy adult female subjects.~   "
194253|NCT01020864|"~     This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of~     cetuximab in combination with carboplatin and vinorelbine as second line treatment in~     patients with recurrent or metastatic head and neck cancer who have progressed during or~     after treatment with first line cisplatinum.~   "
194254|NCT01020851|"~     National recommendations state that patients with a history of transient ischemic attack~     (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive~     medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm~     Hg systolic BP and <80 mm Hg diastolic BP. Statin treatment and lifestyle modification is~     also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a~     history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of~     secondary stroke prevention, there is a gap between evidence and implementation in clinical~     practice. By a randomized controlled trial, the investigators will test whether a tailored,~     telephone-delivered transtheoretical model-based behavioral intervention will improve~     adherence to treatment in veterans with a history of TIA or stroke, thereby leading to better~     control of BP and cholesterol levels, as compared to an attention placebo.~      The primary specific aims of this project are to:~        -  determine whether a behaviorally tailored intervention (TI) can effectively lower BP~          after 6 months of counseling as compared to an attention placebo (AP) in veterans with a~          history of stroke or TIA~        -  assess whether the TI is effective in improving adherence to diet after 6 months of~          counseling in veterans with a history of stroke or TIA.~      Secondary aims are to~        -  assess whether the TI is effective in improving cholesterol levels in post-stroke~          veterans after 6 months~        -  evaluate whether the TI is effective in improving adherence to antihypertensive and~          lipid-lowering medications after 6 months of counseling in veterans with a history of~          stroke or TIA~        -  determine whether the TI is effective in improving adherence to exercise recommendations~          after 6 months.~      To answer this, veterans (n=190) with a history of stroke or TIA will be randomized equally~     to the TI, which will use the transtheoretical framework to provide 6 monthly counseling~     phone sessions about adherence to diet, medication, and exercise recommendations, and the AP,~     in which 6 monthly counseling phone sessions about non-stroke-related health topics will be~     provided. Participants will make in-person visits at baseline and 6 months. BP (3 measures~     taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary~     outcomes will be total cholesterol/high density lipoprotein ratio, adherence to~     antihypertensive and lipid-lowering drugs, and exercise adherence.~   "
194260|NCT01020773|"~     Spontaneous breathing trial (SBT) has long been thought to be a essential process before~     extubation. In this study,the investigator hypothesized that SBT could be not essential~     during weaning from ventilator and investigated whether weaning could be better done without~     a spontaneous breathing trial in non-COPD（COPD, Chronic Obstructive Pulmonary Disease）~     critically ill patients. This study has revealed, for the first time, that compared with use~     of SBT in discontinuing ventilator process, patients underwent successful extubation without~     SBT. For this subset of patients the findings suggest that SBT may be excluded preceding~     extubation in a general intensive care population.~   "
194261|NCT01020760|"~     The purpose of this study is to determine the effect of postoperative posturing on the~     outcome of macular hole surgery. Current practice is divided; some individuals are advised to~     posture face-down for 10 days and others are advised that posturing is unnecessary. By~     evaluating the effect of posturing in a prospective randomised controlled trial the~     investigators hope to determine best practice, enabling surgeons and patients to make~     informed decisions regarding postoperative management.~   "
194262|NCT01020747|"~     This phase I single center open labeled study is planned to assess the safety and~     tolerability of bevacizumab for treating patients with bilateral Recurrent Respiratory~     Papillomatosis (RRP). Approximately 20 patients will receive bevacizumab directly injected~     into the vocal folds. Patients who enroll in the protocol will be injected with bevacizumab~     in one vocal fold that represents the more diseased of the two folds. A sham injection with~     saline will be administered to the other vocal fold as the control. This therapy will be~     administered once every 6 ± 1 week for 6 months, with the same vocal fold selected for the~     initial treatment always getting the drug injection. The investigator will also treat lesions~     by laser photoangiolysis of both vocal folds using the 532 nm potassium-titanyl-phosphate~     (KTP) laser.~   "
194263|NCT01020734|"~     RATIONALE: Giving chemotherapy before a donor bone marrow or peripheral blood stem cell~     transplant helps stop the growth of cancer cells. It also helps stop the patient's immune~     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are~     infused into the patient they may help the patient's bone marrow make stem cells, red blood~     cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can~     make an immune response against the body's normal cells. Giving cyclosporine and methotrexate~     before and after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well donor stem cell transplant or bone marrow~     transplant works in treating patients with acute myeloid leukemia in remission.~   "
194264|NCT01020721|"~     Primary congenital glaucoma, which presents at birth or in infancy, if left untreated, may~     threaten vision. The incidence of congenital glaucoma varies among different geographic~     locations and ethnic groups.~      Three genetic loci for primary congenital glaucoma (GLC3A in 2p21, GLC3B in 1p36, GLC3C in~     14q24.3) were identified. CYP1B1 (cytochrome P450 1B1 ) gene, in the GLC3A locus is the main~     known gene and different CYP1B1 mutations has been described.~      The genetic characteristics in south Korean patients with primary congenital glaucoma have~     not been reported yet and the genotype-phenotype correlations, the prognosis and the genetic~     counseling have not also been established. This study represents the first repot about the~     rate of CYP1B1 mutations, the genotype-phenotype correlations in south Korean patients with~     primary congenital glaucoma.~      Patients with primary congenital glaucoma and their family will be analyzed for CYP1B1~     mutations by direct sequencing of polymerase chain reaction fragments. Primary congenital~     glaucoma will be diagnosed according to the clinical parameters by glaucoma specialists.~     Patients were classified to several groups according to the pattern of mutations. Clinical~     parameters and genotype correlation will be compared between groups~   "
194265|NCT01020695|"~     In this study the Quantitative Electroencephalography and low resolution topographic analysis~     of chronic Post-traumatic stress disorder and normal subjects will be compared.~   "
194266|NCT01020682|"~     Apathy has been reported to occur after subthalamic nucleus stimulation (STN-DBS), a~     treatment of motor complications in advanced Parkinson's disease (PD). It is not known~     whether postoperative apathy is related to dopamine withdrawal or a side effect of STN DBS.~     The researchers investigated potential predictors of apathy, and the effect of dopamine~     agonist treatment.~   "
194267|NCT01020669|"~     Background:~      - Recent research has suggested that prenatal exposure to drugs may affect specific brain~     processes, including working memory, stress response, and decision making. However, most of~     the research on the effects of prenatal drug exposure in humans has been conducted early in~     life, and very little is known about effects of prenatal drug exposure during the crucial~     brain development period that takes place during puberty and adolescence. The biological and~     psychological changes associated with puberty may increase adolescents' sensitivity to~     prenatal substance exposure. Researchers are interested in using functional magnetic~     resonance imaging (fMRI) scans to study brain function and learn more about the effects of~     prenatal drug exposure on adolescents.~      Objectives:~      - To examine the effects of prenatal substance exposure on working memory, decision making,~     and normal brain activity in adolescents.~      Eligibility:~      - Adolescents between 12 and 17 years of age who are enrolled in a larger follow-up study of~     children exposed to drugs in utero.~      Design:~        -  The study will involve a single outpatient session with two fMRI scans that will test~          working memory and decision-making processes.~        -  Participants will have brief medical history, a physical examination, and a urine test~          for drugs of abuse.~        -  Participants will then be trained on the working memory and decision-making tasks before~          having an initial MRI scan to provide a baseline reading.~        -  The fMRI scans will take 40 to 45 minutes each, and participants will have break in~          between as needed.~   "
194268|NCT01020656|"~     Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in~     patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar~     anesthesia between users and non-users.~   "
194269|NCT01020643|"~     The purpose of this study is to compare the administration of a standard anesthetic drug~     (propofol) using an automatic, expert-based system versus a manually controlled system by the~     anesthesiologist. In addition, the performance of the decision support system will be~     evaluated.~   "
194357|NCT01019408|"~     The purpose of this study was to provide stronger evidence for extended-dose chloroquine~     treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP),~     Pakistan or justification for discontinuation of the policy.~   "
194270|NCT01020630|"~     This trial will be conducted to evaluate the efficacy, safety and tolerability of SUNITINIB~     as add-on therapy with a widely used second-line palliative FOLFIRI chemotherapy in patients~     with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus~     (mGC).~      There is a clear scientific rationale for the use of Sunitinib to treat patients with mGC.~     Despite recent therapeutic advances, the median overall survival (OS) in patients with mG is~     still ≤ 12 months. Therefore, newer agents with novel mechanisms of action are desperately~     needed for treatment of these patients.~   "
194271|NCT01020617|"~     Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and~     it is likely that this is also the case in children (Ley et al., 2005). It has also been~     shown that the gut microbiota is different in obese individuals compared to normal weight~     individuals and that the microbiota seems to have a role in fat storage (Backhead et al,~     2004).~      Intervention study with overweight and normal weight school age children. The children will~     be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be~     collected, and anthropometric measurements (weight, height, skin folds) will be recorded~     before and after the intervention. The dynamic of the microbiota of the GI will be monitored~     by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will~     be analysed. Blood samples will be analysed to evaluate how the intervention influence the~     systemic polarization of the immune response by means of cytokine analyses. Furthermore,~     blood pressure, blood lipid profile and early markers of metabolic syndrome will be~     evaluated. Hypotheses This study will examine if overweight in children is associated with a~     different intestinal microbiota and if a change in microbiota caused by probiotics can modify~     inflammation and risk factors for the metabolic syndrome.~   "
194272|NCT01020604|"~     The reports on relationship of obesity and biochemical or clinical recurrence of prostate~     cancer are controversial. Several reports have shown that obesity is associated with~     increased risk of biochemical or clinical failure after radical prostatectomy. Other~     prospective studies have shown no adverse effect of obesity on long-term outcomes after~     prostatectomy. Limited reports are available on the impact of obesity on prostate cancer~     progression after radiotherapy. Primary: to assess percentage recurrence rate among normal~     weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.~     Secondary: to determine the Quality of Life differences among normal and overweight or obese~     prostate cancer patients by a Quality of Life questionnaire~   "
194273|NCT01020591|"~     The purpose of this study is to determine if the use of osteopathic manual therapy can~     influence the vascular supply to the knee, knee range of motion, balance and knee pain, in a~     group of subjects with knee osteoarthritis. It is also the objective of this study to~     determine if there is a difference between the osteopathic evaluation and the combination of~     an osteopathic evaluation and treatment.~   "
194274|NCT01020578|"~     Impaired glucose tolerance is associated with an increased risk of developing cardiovascular~     disease and atherosclerosis for reasons not yet totally understood. Previous studies~     evaluated the kinetics of plasma LDL and a faster removal rate of free cholesterol in~     normolipidemic patients with diagnosed arterial coronary disease and deposits of this~     cholesterol on the blood vessel walls. This disassociation of the cholesterol may suggest a~     new mechanism for not only the genesis but for the progression of arterial coronary disease.~     The objective of this research was to study the plasma kinetics of free cholesterol and~     cholesterol ester in impaired glucose tolerance patient, asymptomatic for coronary artery~     disease (CAD), to elucidate mechanisms involved in atherogenesis in these patients.~   "
194275|NCT01020565|"~     The objectives of this study are to demonstrate that entecavir has antiviral activity with~     undetectable at Week 48, and to assess the safety and the pharmacokinetic in Japanese~     patients given entecavir at each dose of 0.1 and 0.5 mg for 52 weeks~   "
194276|NCT01020552|"~     A descriptive post-intervention study designed to provide data to decision-makers at the~     Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder~     International about whether and how to scale-up the ESD Project's postabortion care (PAC)~     services package. Approximately three months of data will be collected following the~     introduction of postabortion care job aids in eight public sector health facilities in~     Central Province and Nairobi, Kenya. Postabortion clients and providers will be interviewed;~     facilities providing PAC services will be inventoried using facility checklists.~   "
194277|NCT01020539|"~     Allogeneic stem cell transplantation (AlloSCT) followed by targeted immune therapy Gemtuzumab~     Ozogamicin patients with acute myeloid leukemia (AML)/juvenile myelomonocytic leukemia~     (JMML)/myelodysplastic syndromes (MDS) will be safe and well tolerated.~   "
194278|NCT01020526|"~     The main purpose of this study is to evaluate the long-term safety of pregabalin in~     adolescent patients who participated in the previous fibromyalgia study (A0081180) and who~     wish to recieve open-label pregabalin~   "
194279|NCT01020513|"~     This is an observational study examining the workflow dynamics and training requirements that~     support effective use of subcutaneous hydration delivery (a newly FDA approved Baxter~     product) compared to standard intravenous hydration/medication delivery. Emergency~     departments already using both Subcutaneous Recombinant Human Hyaluronidase and standard IV~     hydration will be enrolled. Patients will be receiving the hydration method selected by their~     emergency department physician and the investigators will then observe:~        1. Patient Throughput~             -  Efficiency of patient care and treatment areas~             -  Safety of patient care and treatment areas~             -  Support Service processes that impact patient flow~        2. Clinical Outcomes~             -  Time to conversion from dehydration to hydration'~             -  Rate of complications~        3. Satisfaction~             -  Staff satisfaction with Subcutaneous hydration vs. Intravenous hydration~             -  Patient satisfaction with Subcutaneous hydration vs. Intravenous hydration~   "
194280|NCT01020500|"~     The purpose of the study is to assess the responder rate as defined by the achievement of the~     primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in~     accordance with routine practices.~   "
194281|NCT01020474|"~     This study will compare pregabalin with placebo over a 15 week period in adolescents with~     fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.~   "
194901|NCT01012323|"~     The purpose of this study was to determine the efficacy of NewGam in preventing serious~     bacterial infections and to determine the pharmacokinetic profile of NewGam. The safety of~     NewGam and its effect on quality of life were also evaluated.~   "
194282|NCT01020461|"~     The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous~     blood sampling and placement of peripheral intravenous catheters in adults. This clinical~     protocol is designed to determine whether using Accuvein increases the ease and efficiency of~     venous cannulation (as perceived by the operator), decreases the time to effective~     cannulation, decreases the number of sticks, and decreases the patient's perception of the~     pain.~   "
194283|NCT01020448|"~     The purpose of this study is to evaluate the effect of an initial hormonal treatment~     gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in~     patients with histologically confirmed and advanced stages of prostate cancer. Their~     characteristics, according to risk factors such as PSA and Gleason score will be determined~     at baseline and 1, 3 and 6 month post-treatment.~   "
194284|NCT01020435|"~     The investigators propose a prospective randomized 2 arm parallel observer-blinded phase II~     clinical study comparing a distinct method of upper cervical chiropractic manipulation to a~     sham technique in 50 individuals with stage I hypertension (systolic blood pressure (SBP):~     140-159 mm Hg; diastolic blood pressure (DBP):90-99 mm Hg).~   "
194285|NCT01020422|"~     The aim of this study is to determine the impact of reduction mammaplasty on sexuality and~     depression predictors in women with macromastia.~   "
194286|NCT01020409|"~     The aim of the study is to evaluate a clinically and economically most effective diagnostic~     algorithm for prediction of inflammatory response related complications in patients~     undergoing heart surgery with use of cardiopulmonary bypass.~   "
194287|NCT01020396|"~     The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of~     Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M~     Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical~     equivalence in the treatment of bacterial vaginosis.~   "
194288|NCT01020370|"~     The primary goal of this study will be to explore the reparative and regenerative potential~     of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies~     using conventional and non-conventional MRI sequences.~   "
194289|NCT01020357|"~     Apnea of prematurity is a common condition that is usually treated with methylxanthines.~     Methylxanthines are adenosine receptor blockers that have powerful influences on the central~     nervous system. However, little is known about the long-term effects of methylxanthines on~     the developing brain.~      The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine~     for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of~     methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage~     of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive~     either caffeine or placebo, and are currently receiving detailed neurocognitive and~     behavioral assessments in the CAP trial.~   "
194290|NCT01020344|"~     A randomised controlled trial will be performed to evaluate the effects of lung volume~     reduction surgery (LVRS) in patients with COPD on systemic inflammation, oxidative stress,~     endothelial function, arterial stiffness and blood pressure. We hypothesize that LVRS will~     lead to a reduction of systemic inflammation, oxidative stress, arterial stiffness and blood~     pressure and to improved endothelial function.~      For this purpose 30 patients with severe/very severe COPD (GOLD III-IV) and pulmonary~     emphysema who are to undergo LVRS will be randomised to one of two groups: group 1 receiving~     immediate LVRS and group 2 receiving LVRS after a delay of 3 months.~      Measures of systemic inflammation, oxidative stress, endothelial function, arterial stiffness~     and blood pressure will be measured at baseline and 3 months after surgery and no surgery,~     respectively (group 2 receiving surgery only after a delay of 3 months will serve as control~     group) to investigate the effects of LVRS on the described outcomes.~   "
194291|NCT01020331|"~     Tau, a protein in the cerebrospinal fluid CSF is believed to be elevated in amyotrophic~     lateral sclerosis (ALS) patients. The investigators believe that Tau is truly a marker of~     increased neuronal death from any disease process. It is been shown that Memantine can~     inhibit and reverse the abnormal hyperphosphorylation of Tau and therefore the investigators~     are looking at the efficacy of Memantine at 10 mg twice a day (BID) to see if disease~     progression correlates with possible changes in Tau in ALS patients based on ALS Functional~     Rating Scale (ALSFRS) scores.~   "
194292|NCT01020318|"~     Background:~        -  Traumatic brain injury (TBI) is a significant injury in the Armed Forces, but it is also~          common in the general population. This condition poses significant challenges for both~          diagnosis and therapy. However, the biological and neurological reasons for TBI remain~          poorly understood and are in need of more in-depth study.~        -  The National Institutes of Health is collaborating with several military medical centers~          and research units in a multi-year study of TBI in civilian and military patients. In~          anticipation of these research projects, the Clinical Center s Rehabilitation Medicine~          Department needs to become familiar with the instruments they will likely need to~          evaluate this group of subjects.~      Objectives:~        -  To evaluate potential test instruments in patients with TBI.~        -  To evaluate patient tolerance of an extensive battery of assessments and the time~          required to complete the assessments.~        -  To improve staff competencies on new or novel assessments of the TBI patient population~      Eligibility:~        -  Individuals 18 years of age and older who have been diagnosed with a traumatic brain~          injury in the past 5 years.~        -  Healthy volunteers 18 years of age and older who have had no instances of significant~          head trauma.~      Design:~        -  This study requires approximately 3 days of outpatient or inpatient evaluation.~        -  Subjects will undergo cognitive and neuropsychological tests, physical assessments,~          speech and language evaluation, and balance testing. Tests will be given orally, in~          writing, and on computers. The testing will be done in blocks of 2 to 3 hours, with rest~          periods as needed.~        -  Subjects may undergo any or all of the following assessments and screening tools, as~          determined by the researchers:~        -  Cognitive, quality of life, and functional assessments~        -  Speech, language, and swallowing assessments~        -  Physical functional performance and environment assessments (including balance testing)~        -  Subjects will remain under the care of their own health care providers while~          participating in this study.~   "
194293|NCT01020305|"~     This study evaluates if temsirolimus causes a reduction in the serum levels of~     prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer~     (CRPC).~   "
194294|NCT01020279|"~     1. Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on~          muscle pain of the calf caused by eccentric contractions~        2. Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by~          eccentric contractions~        3. Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the~          calf caused by eccentric contractions~   "
194295|NCT01020266|"~     The purpose of this study is to evaluate the neuroprotective effect of electroacupuncture~     pretreatment in patients undergoing cardiac surgery as an preventive sequela in a randomized~     and controlled clinical trial. In addition, to investigate the role of inflammatory responses~     in the precess of the protection.~   "
194298|NCT01020227|"~     Background: This randomized controlled trial investigates the effectiveness of an Integrative~     Therapies (IT) health education intervention in improving physical and psychological~     functioning in female patients after coronary artery bypass graft (CABG).~      Methods: One hundred female cardiac surgery patients were assigned to either an intervention~     or standard care control group. Patients in the intervention group were given a cardiac yoga~     video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational~     booklet outlining recommendations for dietary change. Patients were followed for 6 months by~     a health educator who provided ongoing education and encouragement and were assessed at 6~     weeks and 6 months post surgery to determine between group differences on physical~     functioning and psychological distress using the SF-36 and the Profile of Mood States~   "
194299|NCT01020214|"~     The objective of this study was to investigate the bioequivalence of Mylan's olmesartan~     medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg~     tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under~     fasting conditions.~   "
194300|NCT01020201|"~     Risk factors for postoperative nausea and vomiting(PONV) such as past history of PONV and/or~     motion sickness, non-smoking status, female gender, planned opiate use for post-operative~     analgesia were identified in white people. Whereas, risk factors for PONV in female patient~     with mongolian race were not clear. As a different life style and genetic background, new~     risk factors may associate with PONV in this population. The present study is a prospective~     cohort study to identify risk factors for PONV within 24 postoperative hours in chinese~     female patients underwent gynecology operative under general anesthesia.~   "
194301|NCT01020188|"~     Paroxysmal nocturnal haemaoglobinuria (PNH) is a rare disease which results in breakdown of~     the red blood cells and bone marrow failure. It is associated with an increased risk of blood~     clots. Until recently, treatment has been with blood transfusions and in patients with a~     blood clot, blood thinners. A new treatment called eculizumab is now standard for patients~     who require regular blood transfusions. It works in the majority of patients by preventing~     the breakdown of red blood cells. This can eliminate the need for blood transfusion and~     reduce the risk of blood clots. It is not well understood why patients with PNH are at high~     risk of blood clots. The investigators plan to use specialised blood tests to assess the~     stickiness of the blood before starting eculizumab treatment and monthly after starting~     treatment. The investigators will compare these tests with standard tests of clotting.~   "
194302|NCT01020175|"~     350 patients with early leukemias were assigned to receive peripheral blood or bone marrow~     transplantation; the occurrence of acute and chronic graft versus host disease, survival,~     transplantation-related mortality, and relapse rates were compared.~   "
194303|NCT01020162|"~     Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of~     chronic pelvic pain. The objective of the present study was to assess pain and quality of~     life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after~     surgery but also found without previous surgery. In a controlled prospective cross-over study~     19 women were randomized either to medical treatment or to resection of the nerve.~     Statistically significant improvements were found after surgical resection.~   "
194304|NCT01020149|"~     To prospectively evaluate the nerve regeneration after traumatic nerve transsection using~     diffusion tensor magnetic resonance imaging (DTI MR imaging).~   "
194305|NCT01020136|"~     The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug~     concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing~     under fed conditions.~   "
194306|NCT01020123|"~     The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on~     Treatment to Metformin in TD2M Patients~   "
194307|NCT01020110|"~     Evaluation of fibrin and platelet deposition on a human umbilical endothelial cell surface in~     perfusion chamber experiments using human whole blood.~      Open-label, non interventional study Perfusion chamber experiment will be performed in 30~     healthy patients. The Impact of different pH-solutions on thrombus lysis will be evaluated in~     an in-vitro second step~      Outcome:~      D-Dimer content of the thrombus reflecting the size of the thrombus.~   "
194308|NCT01020084|"~     The purpose of this study was to investigate if salivary flow rate is important to maintain~     adequate oral functions.~   "
194309|NCT01020071|"~     Objective: The main objective of this study is to evaluate the efficacy of Pascal Laser~     Iridotomy and Pascal Laser Peripheral Iridoplasty in lowering intraocular pressure and~     opening up the angles in patients with narrow angles, primary angle closure and primary angle~     closure glaucoma.~      The specific objectives are to evaluate the pain and inflammation associated with the~     procedure and its possible adverse effects on the lens and corneal endothelium.~      Study Design: Prospective, interventional case series Study Population: Healthy males and~     females with appositional angle closure aged 21 y/o and above Methods: Potential participants~     are evaluated by a glaucoma specialist in National University Hospital. If they are~     identified as having appositional angle closure they are invited to participate in the study~     and assigned to either iridotomy or iridoplasty depending on the mechanism of angle closure~     present. Pupil block for Pascal Laser Iridotomy and plateau iris and angle crowding for~     Pascal Laser Peripheral Iridoplasty. If they agree to participate they will undergo visual~     acuity, slit lamp examination, intraocular pressure determination by Goldmann Applanation~     Tonometry, gonioscopy, optic nerve head evaluation by indirect ophthalmoscopy and lens~     evaluation by LOCS III opacity grading system. Humphrey visual field examination using 24-2~     SITA standard algorithm and stereodisc photos will be obtained if not done within the past 12~     months. Anterior segment OCT and laser flare meter will also be performed prior to the~     procedure. Enrolled patients will be divided into 2 groups. The first group will be assigned~     to Pascal Laser Iridotomy. The primary mechanism of angle closure in this group is pupillary~     block. The second group will be assigned to Pascal Laser Peripheral Iridoplasty. This group~     has non-pupil bock mechanisms which include plateau iris or angle crowding. After the laser~     procedure, follow-up examinations will be done 1 hr post laser, 1 week, 1 month, 3 months and~     6 months.~      Outcome Measures: The primary outcome measures are the intraocular pressure difference pre~     and post laser and the opening of angles. Secondary outcome measures are pain and~     inflammation associated with laser procedure, lens and corneal endothelial changes.~   "
194310|NCT01020058|"~     The purpose of this study is to compare the frequency of long-term post operative pain after~     an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an~     totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The~     investigators will also be assessing the cost for the procedures and hospital care as well as~     the cost for sick-leave depending on procedure performed. The study hypothesis is that the~     laparoscopic approach will be associated with less long term post operative pain.~   "
194358|NCT01019395|"~     This is a research study designed to look at the pharmacokinetics (distribution, breakdown,~     and removal) and tolerability of a single dose of daptomycin in patients aged 3 months to 24~     months who have proven or suspected infections that are caused by a specific group of~     bacteria (called Gram-positive bacteria)or perioperative subjects that are receiving~     prophylactic antibiotics .~   "
194311|NCT01020045|"~     Advances in HAART have been a huge success story in the management of HIV infection. However,~     serious metabolic complications including osteoporosis and bone fractures are increasingly~     been seen with HAART, and the responsible mechanisms remain poorly elucidated.~      The skeleton continually regenerates through homeostatic bone remodeling. Osteoclasts the~     cells responsible for bone resorption form under the influence of the key osteoclastogenic~     cytokine Receptor- Activator of NF-KB (RANKL). The osteoclastogenic and pro-resorptive~     activities of RANKL are moderated by its physiological decoy receptor osteoprotegerin (OPG).~     Increase in the ratio of RANKL to OPG accelerates the rate of osteoclastic bone resorption~     leading to osteoporosis.~      The investigators' preliminary studies have now demonstrated that in an animal model of~     HIV/AIDS, the HIV-1 Transgenic rat, the development of osteoporosis is recapitulated as~     observed in human patients. Furthermore, the investigators found that B cell expression of~     OPG is significantly downregulated, concurrent with a significant upregulation in production~     of RANKL.~   "
194312|NCT01020032|"~     The aim of study is to assess the effects of this new music therapy technique on pain~     treatment, anxiety and depression and on medicinal consumption.~   "
194313|NCT01020019|"~     The purpose of this study is to see if Lofexidine in combination with Marinol is superior to~     placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in~     cannabis-dependent patients seeking treatment for their marijuana use.~   "
194314|NCT01020006|"~     The purpose of this study is to evaluate the safety and tolerability of selected dose~     1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or~     locally advanced pancreatic cancer patients receiving concurrent therapy with intravenously~     administered gemcitabine for 12 weeks.~   "
194315|NCT01019993|"~     The investigators hypothesized that the application of volume-controlled HFPPV to the~     non-dependent lung during one-lung ventilation (OLV) for thoracotomy in patients with good~     pulmonary functions and mild-to-moderate pulmonary dysfunction may provide preservation of~     the right ventricular (RV) function, adequate oxygenation and optimum surgical conditions.~      The investigators evaluated the effects of IL-HFPPV on RV ejection fraction (REF), RV~     end-diastolic volume (RVEDVI), RV stroke work (RVSWI), pulmonary vascular resistance (PVRI),~     and stroke volume (SVI) indices, oxygen delivery (DO2) and uptake (VO2), shunt fraction (Qs:~     Qt), and surgical field conditions during OLV for thoracotomy in patients with good and~     mild-to-moderate impaired pulmonary functions.~   "
194316|NCT01019980|"~     The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg)~     is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of~     fever during 2 hours, in the treatment of febrile children with acute upper respiratory~     infections.~      This is a comparative double blind, double dummy, randomized study on the effectiveness of~     Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory~     tract infections. The patient will be randomized to either group: Group A (Diclofenac~     potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional~     trained will measure the temperature during 2 hours. During the study period, parents or~     legal representatives will be invited to fill a survey about the habits and knowledge~     regarding fever management at home.~   "
194317|NCT01019967|"~     Background:~        -  Obsessive-compulsive disorder (OCD) is a common childhood disorder that often does not~          respond to standard treatments. Researchers are exploring the role that a brain chemical~          called glutamate plays in symptoms of OCD, and are testing a drug called riluzole that~          reduces glutamate to see if changing the levels of glutamate in the brain will help~          treat the disorder.~        -  Researchers are interested in using magnetic resonance spectroscopy (MRS), a type of~          magnetic imaging, to take pictures of various chemicals in the brain. MRS images will be~          used to detect changes in brain levels of glutamate in children taking riluzole.~      Objectives:~      - To use magnetic resonance spectroscopy to study the levels of glutamate in the brains of~     children and adolescents who have been taking riluzole.~      Eligibility:~      - Children and adolescents ages 7 to 17 who are enrolled in the current NIMH riluzole trial~     protocol (05-M-0225), who are able to lie still in the scanner for about an hour each time,~     and who are willing to have up to three MRS scans.~      Design:~        -  Researchers will study some children/adolescents before they begin to take the study~          medication riluzole or placebo these children will have an MRS scan before starting the~          study medication. The scan will take about an hour.~        -  About 2 weeks after reaching the full dose on the study medication, participants will~          have a second hour-long MRS scan. Participants will have a third MRS scan after being on~          the study medication for 12 weeks.~        -  Some children who have already completed 12 weeks on riluzole or placebo, and are now~          taking riluzole, will have only one MRS scan.~   "
194318|NCT01019941|"~     The purpose of this study is to evaluate safety and the pharmacokinetic characteristics of~     docetaxel between two docetaxel products in patients with advanced solid cancer.~   "
194319|NCT01019928|"~     The purpose of the study is to compare sensitivity of visceral pain in the esophagus using~     different pain stimuli.~   "
194320|NCT01019915|"~     Heart failure patients with left bundle branch block have a poor prognosis. Biventricular~     pacing which synchronize the heart pump action is associated with improved functional~     capacity. This study aims to evaluate the basic changes in skeletal muscle functioning after~     a period of biventricular pacing in 21 patients with heart failure.~   "
194321|NCT01019902|"~     This study aims to determine how maternal Fe status influences placental and neonatal Fe~     status in pregnant adolescents and to assess the impact of the Fe endowment of birth on~     functional outcomes as assessed by auditory brainstem responses within 48 h of delivery in~     neonates born to these adolescents.~   "
194322|NCT01019889|"~     The purpose of this study is to determine whether Socheongryong-tang (SCRT) and~     Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection.~   "
194323|NCT01019876|"~     Reduced intensity conditioning followed by allogeneic stem cell transplantation will result~     in mixed/complete donor chimerism and potentially alter the natural history and outcome of~     patients with non-malignant diseases.~   "
194324|NCT01019863|"~     Evaluation of the efficacy, tolerance, quality of life and cost effectiveness of the~     association of Oxaliplatin, Gemcitabine, Rituximab and Dexamethasone for treatment of~     patients with refractory or relapsing non-Hodgkin lymphoma.~   "
194325|NCT01019850|"~     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Radioactive drugs, such as iobenguane I 131, may carry radiation~     directly to tumor cells and not harm normal cells. Giving vorinostat together with iobenguane~     I 131 may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of giving vorinostat~     together with iobenguane I 131 in treating patients with resistant or relapsed neuroblastoma.~   "
194326|NCT01019837|"~     The spread of Influenza H1N1 has prompted the development of vaccines against this virus. IBD~     patients are at increased risk of developing complications of Influenza H1N1. The efficacy~     and safety of H1N1 vaccination have not been evaluated in this population of patients. We~     would like to estimate the efficacy and safety of vaccination against influenza H1N1 in~     patients with IBD who treated with immunomodulatory drugs.~   "
194327|NCT01019824|"~     The aim of the study is to determine if an experimental drug, ralfinamide, relieves your~     neuropathic low back pain, and if it demonstrates superiority to placebo, a dummy or sugar~     pill that contains no active medication. Ralfinamide, given as either 160 mg/day or 320~     mg/day, taken in a divided dose twice-a-day, will be compared with placebo. If you are~     randomly (by chance) selected to receive placebo, you will receive this medication throughout~     the treatment period of the study. Data from this study will provide essential information~     for choosing the doses of ralfinamide to be used in the treatment of this type of pain and~     potentially other types of pain.~   "
194328|NCT01019811|"~     The purpose of this study is to introduce a new operative technique for reconstruction of~     fingertip degloving injury.~   "
194329|NCT01019798|"~     Sunitinib shows anti-tumor activity in a variety of human non-small cell lung tumor ex vivo~     models. Many Phases II and III clinical trials of sunitinib in several solid tumors are~     completed or still ongoing. So far, the efficacy of sunitinb has been confirmed by the phase~     III trial for imatinib-resistance or intolerance advanced gastrointestinal stromal tumor~     patients. And sutent was approved to effective by two phase II trials in advanced renal cell~     carcinoma patients after failure of immunotherapies, and one phase III trial in~     treatment-naive advanced renal carcinoma patients. Sunitinib (SUTENT ®) has been approved by~     U.S. Food and Drug Administration (FDA) for the treatment of advanced renal carcinoma~     patients and in gastrointestinal stromal tumor patients who are intolerant or progressed~     after imatinib mesylate. European Medicines Agency (EMEA) conditionally granted the marketing~     approval for the treatment of metastatic renal carcinoma patients after failure of~     immunotherapy.~      A phase II trial (A6181040 study) on non-small cell lung cancer patients treated with~     sunitinib alone showed anti-tumor activity. In 63 enrolled patients treated with 4/2 schedule~     (4 weeks treatment, then two weeks interruption), 7 patients are confirmed partial response~     (overall response rate, 11%), and median progress-free time is 14.3 weeks. Presently, a phase~     III study is underway on non-small cell lung cancer patients followed by and now is under~     recruiting.~      Non-small cell lung cancer cells often over-express vascular endothelial growth factor (VEGF)~     receptors. Besides, the expression of the VEGF ligands is also correlated with increased~     tumor angiogenesis, as well as shortened survival time. One study treated with VEGF-directed~     monoclonal antibody (bevacizumab) and VEGFR and platelet-derived growth factor receptor~     (PDGFR) small molecule inhibitors (sunitinib) showed that some non-small cell lung cancer~     patients are with anti-tumor activity.~      The chemotherapy drugs, such as docetaxel and platinum-based compounds, were with evidence~     that they have direct cytotoxicity to cancer cells. Therefore, the investigators are paying~     attention to the efficacy of combining sunitinib and conventional chemotherapy in this study.~      The study is designed as first line of salvage therapy on metastatic or unresectable~     non-small cell lung cancer patients. The main goals of this study is to evaluate the overall~     response rate (ORR) and duration of response (DR) of sunitinib in combinational with~     docetaxel and cisplatin in chemotherapy-naive advanced or metastatic non-small cell lung~     cancer patients.~   "
194330|NCT01019785|"~     During IVF treatment women will be randomized into supplementation with a high or a low dose~     of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home~     rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA,~     Diabetes) 2.Thrombin generation~   "
194331|NCT01019772|"~     The purpose of this study is to evaluate and compare the immunogenicity and safety of~     LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™~     at vaccination in healthy infants at their 2, 4, and 6 months of age.~   "
194332|NCT01019759|"~     The hypothesis being studied is that add-on arrhythmia surgery in patients with atrial~     fibrillation (AF) undergoing valvular or coronary surgery improves quality of life, is~     cost-effective, reduces perioperative and long-term morbidity associated with AF.~   "
194333|NCT01019746|"~     The purpose of this study is to compare the administration of the standard anesthetic agent~     (propofol) using this automatic system with the manual administration of propofol by the~     anesthesiologist.~   "
194334|NCT01019733|"~     The purpose of this study is to determine whether the plasticity of autologous intrathecal~     hematopoietic cells would improve the neurologic evolution of the pediatric patients with~     hypoxic/ischemic brain injury.~   "
194335|NCT01019707|"~     This is a study of 4 nontreatment seeking individuals who were MA-dependent and the safety~     and tolerability of atomoxetine. This double-blind, placebo-controlled, within-subjects study~     is to determine the safety and tolerability of atomoxetine.~      MA abusing participants will undergo a 1-day outpatient screening and if it is safe for the~     participants to proceed with the study they will participate in two inpatient components of~     the study that will occur in the University of California Los Angeles (UCLA) General Clinical~     Research Center (GCRC). The first inpatient stay will be 15 days, and the second will be a 9~     days stay that includes drug administration and assessments. There will be at least a two~     week interval between inpatient components. During the inpatient components participants will~     receive alternating study drugs; atomoxetine or placebo and four sessions of IV MA~     administration or saline.~   "
194336|NCT01019694|"~     The primary objective of this study is to evaluate long-term safety and patient acceptability~     of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol~     Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT~     Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.~   "
194337|NCT01019681|"~     The purpose of this study is to determine whether treatment with umbilical cord blood stem~     cells will improve blood flow to the most severely affected leg of a participant with~     medically refractory and non-surgical peripheral vascular disease of the lower extremity.~   "
194338|NCT01019668|"~     The purpose of this study is to evaluate the effectiveness as well as the detrimental~     influence of half-dose and half-fluence modification of verteporfin photodynamic therapy~     (PDT) for the treatment of prolonged unresolved central serous chorioretinopathy (CSCR).~   "
194339|NCT01019655|"~     The purpose of this study is to investigate whether heparin is an effective treatment in~     pregnant women at risk for thrombosis and other pregnancy-associated complications.~   "
194381|NCT01019044|"~     Prospective study in HIV-1 infected patients with a plasma viral load below the limit of~     detection and stable for at least 5 years.~   "
194340|NCT01019642|"~     Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation~     (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes~     mellitus.~      The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein~     (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM).~      The trial was conducted from March to October 2008 at the Hospital of the Mexican Social~     Security in Cuernavaca, Mexico.~   "
194341|NCT01019629|"~     To determine if patients with a deficiency of alpha-galactosidase A are at-risk for cardiac~     complications that commonly occur in the general population~   "
194342|NCT01019616|"~     The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled~     study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can~     increase distant disease free survival(DDFS) in operable patients non-response to primary~     chemotherapy.~   "
194343|NCT01019603|"~     The purpose of this study is to assess systemic exposure of a new foam formulation of~     tazarotene, 0.1% compared with Tazorac Gel, 0.1%. The study design and dosing regimen are~     based on previous clinical studies with Tazorac Gel and Tazorac Cream.~   "
194344|NCT01019590|"~     The objective of this study was to investigate the bioequivalence of Mylan's olmesartan~     medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg~     tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fed~     conditions.~   "
194345|NCT01019577|"~     The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in~     subjects with metastatic breast cancer previously treated with an anthracycline and who are~     taxane resistant.~   "
194346|NCT01019564|"~     The aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose~     solution in terms of lens cleanliness, subjective response and ocular response, when lenses~     are worn bilaterally on a daily wear basis for two months.~      The hypotheses for this trial are:~        -  Lens cleanliness measures between solutions will be no different.~        -  Subjective ratings between solutions will be no different.~        -  Ocular response between solutions will be no different.~   "
194347|NCT01019551|"~     Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral~     therapy plus immunomodulation~   "
194348|NCT01019538|"~     The purpose of this study is to evaluate if supplemental oxygen during air travel can be~     reliably titrated using a Hypoxia-altitude simulation test (HAST). Also, the effect of oxygen~     supplementation given with the various oxygen equipment allowed for air travel is studied.~   "
194349|NCT01019525|"~     The purpose of this study is to characterize the posture and respiratory function of~     mouth-breathing children.~   "
194350|NCT01019499|"~     The purpose of this study is to investigate the effects of berry consumption on indicators of~     cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).~   "
194351|NCT01019486|"~     Cardiovascular disease (CVD) remains the major cause of mortality and morbidity in both type~     1 (T1D) and type 2 (T2D) diabetes patients; modifications of traditional CVD risk factors~     have had a limited impact. This project called Regadenoson Blood flow in Type 1 Diabetes~     (RABIT1D) and is proposed as a sub-study of the Coronary Artery Calcification in Type 1~     Diabetes (CACTI) study, which has established a unique cohort of 656 T1D patients (age 20-55,~     minimal diabetes duration of 10 yrs) and 764 non-diabetic controls. This cohort is being~     followed for progression of coronary artery calcification (CAC) measured using the electron~     beam tomography (EBT) for development of clinical CVD. Participants have been well~     characterized during the baseline examination (4/00-3/02) and two follow-up re-examinations 3~     and 6 years later. The study has provided important insights into the risk factors and~     possible prevention of premature CVD in T1D. We are proposing assess a subset of this~     population to determine vasodilatory reserve as it relates to early coronary atherosclerosis~     in T1D.~      Hypothesis: that myocardial blood imaging (MBF) reserve can be measured in Type 1 diabetes~     mellitus (DM) using regadenoson stress cardiac magnetic resonance and that significantly~     reduced MBF is a marker of extensive atherosclerotic disease correlated to coronary arterial~     calcification, plaque formation and impaired vasodilatory reserve.~   "
194352|NCT01019473|"~     This study will assess the efficacy, safety and tolerability of AFQ056 when added to optimize~     standard therapy in patients that have Huntington's disease in reducing chorea.~   "
194353|NCT01019460|"~     The aim of this study is to evaluate three diagnostic methods for assessing small bowel~     disease in patients with suspected or known Crohn's disease. All patients are examined with~     ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. However,~     capsule endoscopy is not performed in patients with stenosis detected at ileo-colonoscopy,~     MRI and/or CT. All investigations are described in a similar pre-defined and standardized~     fashion and the radiologist and physician responsible for describing the findings at MRI, CT~     and capsule endoscopy are blinded to the findings at ileo-colonoscopy. The physician in~     charge of treatment receives a randomised result of either MRI, CT or capsule endoscopy.~     Thereafter patients are followed during 12 months to evaluate differences in clinical outcome~     depending on the randomized result. In combination with the diagnostic validity and~     inter-observer agreement of MRI, CT and capsule endoscopy we seek to establish the optimal~     diagnostic strategy in these two patient categories.~   "
194354|NCT01019447|"~     To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910~     antimicrobial sutures for the reduction of surgical site infections and any associated health~     and economic benefits.~   "
194355|NCT01019434|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Temsirolimus may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as temozolomide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet~     known whether radiation therapy is more effective when given together with temsirolimus or~     temozolomide in treating patients with glioblastoma.~      PURPOSE: This randomized phase II trial is studying giving radiation therapy together with~     temsirolimus to see how well it works compared with giving radiation therapy together with~     temozolomide in treating patients with newly diagnosed glioblastoma.~   "
194356|NCT01019421|"~     The purpose of this study is to accept or reject the hypothesis that Lu AE58054 improves~     cognition and functional outcomes in patients with moderate Alzheimer's Disease, already in~     treatment with donepezil.~   "
194359|NCT01019382|"~     Over 7000 patients are diagnosed with pancreas cancer every year in the UK. Only 10% have it~     caught early enough to have surgery to cure it. The rest at best can undergo chemotherapy to~     extend survival, but current treatments offer at best an improvement of only a few months~     compared to no treatment at all. In addition only about a quarter of patients will respond to~     the treatment. In addition these patients often experience profound weight loss, loss of~     appetite and energy primarily because of the cancer process itself. Our hypothesis is that~     the addition of fish oil infusion to gemcitabine chemotherapy will result in an improved rate~     of tumour response on CT imaging.~      Fish oils, or specifically the omega-3 fatty acid component, appear to have a range of~     powerful anti-cancer actions. This is supported by evidence from a wide range of sources,~     from laboratory experiments to basic human studies. Although this evidence specifically~     includes many pancreatic cancer studies in the laboratory it has not yet been confirmed in~     human trials.~      Contrary to conventional chemotherapy, fish oil is a naturally occuring non-toxic compound~     and so is not associated with the side-effects of chemotherapy. In fact a number of clinical~     studies have demonstrated significant improvements in quality of life for pancreas cancer~     patients treated with fish oil, particularly with reference to improvements in appetite and~     energy levels. This is of course in addition to the anti-cancer actions.~   "
194360|NCT01019369|"~     Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for~     many women. However, difficulty in access may cause many women to discontinue use, often~     without the use of another effective method of contraception, thereby leaving them vulnerable~     to unintended pregnancy. This study will randomly assign women who present for contraceptive~     services to two groups: self or clinic administered SC DMPA. The participants will be~     followed for one year to compare continuation rates, acceptability, cost effectiveness,~     evidence of skin changes, and need for continued support between the two groups.~   "
194361|NCT01019356|"~     The investigators hypothesis is that free fatty acids (FFA) accumulation in non fatty tissues~     would lead to insulin resistance and hyperandrogenism in PCOS women. Accordingly, Peroxisome~     Proliferator-Activated Receptor gamma (PPARγ) agonist (rosiglitazone) would be a great~     therapeutic option for PCOS as their activation induces transcription factors of gene~     implicated in fatty acids metabolism.~      The aim is to verify if insulin-related hyperandrogenism can be reversed in women having~     polycystic ovary syndrome following an 8-week treatment with rosiglitazone compared to simple~     insulin reduction with acarbose.~      For the purpose of this study, 14 lean women (BMI ≤ 25 kg/m2) and 36 obese women (BMI 30-39~     kg/m2) with PCOS as well as 14 lean and 14 obese control women will be recruited to determine~     their insulin sensibility (insulin levels, M-value, metabolic clearance rate of glucose)and~     FFA metabolism (FFA levels, rythm of apparition and disapearance of FFA) during a 75g oral~     glucose tolerance test and a 2-step insulin-glucose clamp.~   "
194362|NCT01019343|"~     Background:~        -  Previous studies have given researchers information on how the brain controls movement,~          how people learn to make fine, skilled movements, and why some people have movement~          disorders. However, further research is needed to learn more about the causes of most~          movement disorders, such as Parkinson's disease.~        -  By using small, specialized studies to evaluate people with movement disorders and~          compare them with healthy volunteers, researchers hope to learn more about the changes~          in the brain and possible causes of movement disorders.~      Objectives:~        -  To better understand how the brain controls movement.~        -  To learn more about movement disorders.~        -  To train movement disorder specialists.~      Eligibility:~        -  Individuals 18 years of age or older who have had a movement disorder diagnosed by a~          neurologist and are able to participate based on the specific requirements of the small~          study.~        -  Healthy volunteers 18 years of age or older.~      Design:~        -  Participants will have a screening visit with medical history, physical examination, and~          questionnaire to determine eligibility. Eligible participants will give consent to~          participate in up to seven additional outpatient visits for study procedures. The number~          of sessions and the procedures needed for participation depend on specific symptoms.~        -  Participants must avoid drinking alcohol or caffeinated drinks (sodas, coffee, and tea)~          for at least 2 days (48 hours) before each session.~        -  Potential studies may include magnetic resonance imaging (MRI) scans, functional MRI~          scans, electroencephalography, magnetoencephalography, transcranial magnetic~          stimulation, nerve and sensory stimulation, or movement and mental tasks during any of~          the above procedures.~        -  This study does not provide treatment for movement disorders. Participants will not have~          to stop any treatment in order to participate.~   "
194363|NCT01019330|"~     Cardiac catheterization has traditionally been performed via access to the arterial~     circulation from the femoral artery located in the groin. As an alternative to this approach,~     the radial artery, located in the arm, is gaining wider use in clinical practice. Multiple~     studies have demonstrated that cardiac catheterization via the radial approach has a very low~     complication rate, in the short term. This study is intended to determine if there are any~     differences in the long term complication rate between radial artery cardiac catheterization~     as compared with femoral artery cardiac catheterization.~   "
194364|NCT01019317|"~     The goal of this clinical research study is to learn if the combination of fludarabine and~     cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic~     Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this~     drug combination will also be studied.~   "
194365|NCT01019291|"~     It seems that the aldehydes and NO2, at the levels found indoor, could be the aggravating~     factors for an allergic response. However this effect has not been demonstrated. The~     investigators plan to study the effect of exposure to standard doses of these pollutants on~     the bronchial reactivity as measured by bronchial challenge tests with dust mite extract in~     volunteers asthmatic, allergic to house dust mite.~   "
194366|NCT01019265|"~     This trial was designed for comparison and evaluation of the efficacy and safety of~     buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol~     (Tridol® SR (slow release) tablet 100mg) in patients with moderate to severe pain due to~     osteoarthritis.~   "
194367|NCT01019252|"~     The proposed study will be an initial test of a cognitive-behavioral intervention for~     adolescents with ADHD who are receiving medication treatment. It is based on our successful~     work with adults with ADHD who have been treated with medicines but are still having~     symptoms. It involves learning skills for organization and planning, attention, and mood.~   "
194382|NCT01019018|"~     The purpose of this study is to compare the efficacy of olive tip cannula to the standard~     Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract~     surgery.~   "
194404|NCT01018706|"~     The purpose of this study is to confirm or confute the hypothesis that in patients treated~     with primary pci is not always possible to collect an adequate medical history, the~     investigators created a clinical registry in which the investigators collect current or~     previous medical history relevant to DES utilization , in two distinct times.~   "
194368|NCT01019239|"~     The aim of the study is to compare patient outcome following standard of care (Hartmann's or~     resection with anastomosis and defunctioning stoma) and a 'new therapy' (laparoscopic lavage~     alone) for the treatment of acute perforated non-faeculant diverticulitis in Irish hospitals.~      Perforated diverticulitis requires emergency surgery. This carries significant risks and~     mortality as high as 15% during the index admission has been reported. Our group has~     established the safety of laparoscopic lavage alone on the largest cohort to date in a~     prospective multi-institutional study of 100 patients, providing convincing evidence that~     laparoscopic lavage alone is a reasonable alternative to resection for non-faeculant~     perforated diverticulitis. Our aim now is to translate this well-established study design~     into a protocol for a multi-institutional randomised control trial as direct comparison is~     the only way to provide convincing evidence of one modality over another.~      All patients will be followed up for twelve months and primary (operative and in-hospital~     mortality) and secondary (in-hospital and post-discharge morbidity; rates of stoma formation;~     rates of re-presentation with diverticulitis with or without perforation.) end-points will be~     recorded.~      Sample size calculations reveal that a patient cohort of 100 in each arm will be sufficient~     to detect a difference in morbidity and mortality between groups The ratio between Hinchey 3~     and Hinchey 4 is estimated to be approximately 2:1. In order to guarantee sufficient sample~     size, therefore, 300 patients must fulfil the study criteria allowing for exclusion of 100 at~     time of operation~   "
194369|NCT01019226|"~     Trial of new work in progress (WIP) sequences in MRI.~   "
194370|NCT01019213|"~     Conventional right ventricular (RV) apical pacing may result in asynchronous ventricular~     contraction with delayed left ventricular activation, interventricular motion abnormalities,~     and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous~     contraction and may prevent a decrease in left ventricular ejection fraction.~      Hypothesis: His-pacing preserves left ventricular function and is a feasable alternative~     compared to RV septal septal pacing in patients with AV-block.~   "
194371|NCT01019200|"~     Psoriasis patients are known to be at increased risk for heart disease. This may be due to~     the increased prevalence of cardiovascular disease risk factors in this population, including~     high blood pressure, diabetes, obesity, and high cholesterol. Although cholesterol levels are~     known to be altered in psoriasis, most studies have used standard lipid profiles to measure~     cholesterol. These tests indirectly measure LDL (bad cholesterol) and become less accurate~     when triglyceride levels are high, as often see in individuals with psoriasis. We have~     designed a case-control study that uses a more specific and detailed cholesterol test to~     measure serum lipid levels in psoriasis patients, allowing for more accurate determination of~     LDL and better assessment of the lipid-contribution to cardiovascular risk. We will also~     measure other markers of inflammation that may contribute to cardiovascular disease.~   "
194372|NCT01019174|"~     The purpose of this study is to investigate the efficacy and tolerability of LEN/low-dose DEX~     and continuous low-dose CY administered orally compared to LEN in combination with low-dose~     DEX and single CY doses IV in patients with relapsed MM.~   "
194373|NCT01019161|"~     The purpose of the study is to assess how AZD1152 is absorbed or excreted in and out of the~     body in patients with Acute Myeloid Leukaemia (AML).~   "
194374|NCT01019148|"~     Recessive dystrophic epidermolysis bullosa (RDEB) is a disease caused by genetic mutations in~     the gene for type VII collagen. Patients with RDEB develop large, severely painful blisters~     and open wounds from minor trauma to their skin. We are screening subjects with RDEB to~     evaluate characteristics of the subjects and their cells in order to develop new strategies~     of therapy and determine whether subjects could be candidates for treatment studies.~   "
194375|NCT01019135|"~     The purpose of this study is to compare women's cardiac rehabilitation program adherence~     across three program models.~   "
194376|NCT01019109|"~     The purpose of this study is to find out the outcomes of using the PASS LP System to correct~     idiopathic scoliosis. This system is a unique set of spinal instrumentation used to~     surgically correct the rotation and deformity of the spine that is caused by scoliosis. Also,~     this study wants to find out the effects this system has on the physical appearance and~     quality of life for patients with scoliosis.~   "
194377|NCT01019096|"~     The three specific aims of this study are 1) to assess the impact of iron status on relative~     differences in absorption of heme and non-heme iron among pregnant women and non-pregnant~     women, 2) to assess the magnitude and the determinants of heme and non-heme iron transfer to~     the fetus over the last trimester of pregnancy, and 3) to characterize relationships between~     placental iron binding proteins with the enrichment of stable iron isotopes in the neonate at~     birth. The investigators hypothesize that there will be up regulation of heme and non-heme~     iron absorption and up regulation of placental iron transport proteins in response to low~     maternal iron stores.~   "
194378|NCT01019083|"~     The efficacy and immunogenicity of enteric vaccines have generally been found to be lower in~     children in the developed than in the developing countries. This has been observed with~     vaccines against cholera rotavirus, ETEC and typhoid vaccines. There are a number of factors~     that may contribute to such differences in vaccine take rates in children, e.g. breast~     feeding and nutritional status of the children might influence their immunogenicity and~     efficacy. Thus, breast feeding of newborn and young infants may adversely influence the~     immune response to vaccination, which might have more pronounced effect in developing than in~     developed countries. Breastfeeding has also been shown to interfere with the serum immune~     responses to rotavirus vaccine although this effect could be overcome by administering three~     rather than one dose of the oral rotavirus vaccine. Our recent study of Dukoral in~     Bangladeshi children aged 18 months or younger has shown that the response rates and the~     magnitude of responses improved when breast milk was temporarily withheld . Thus,~     administration of vaccines may have to be adjusted when given to breast fed children. Another~     factor that may affect the immunogenicity is the effect of zinc. Previous studies have shown~     that zinc enhances the immune response to cholera vaccine in participants > 2 years of age ,~     a recent study also observed a similar effect in infants.~      In this research project, we plan to study a number of different factors that might influence~     the immunogenicity of the two licensed oral model vaccines, specifically the inactivated~     killed oral cholera vaccine, Dukoral, and the live oral typhoid vaccine, Ty21a. We will also~     identify strategies that might improve the immunogenicity of the vaccines. The main objective~     of our study is to identify immunization regimens that may improve the immunogenicity of the~     vaccines in young children, which could be subsequently in field trials in Bangladesh and~     other developing countries. Specifically, we will determine if: (i) interventions identified~     to enhance immune responses to Dukoral, including zinc supplementation, could also enhance~     the immune responses to Ty21a; (ii) these two vaccines are able to induce both acute and~     memory B and T cell responses, (iii) treatment with antiparasitic drugs prior to immunization~     could modulate the immune responses to cholera and typhoid vaccines; and (iv) examine if~     arsenic exerts a suppressive effect on the immunogenicity of these vaccines.~   "
194379|NCT01019070|"~     The purpose of this study is to assess the effects of hepatic impairment on the multiple dose~     pharmacokinetics of BMS-650032.~   "
194380|NCT01019057|"~     Patients diagnosed with single-level degenerative disc disease (DDD) of the lumbar spine~     undergo a posterior decompression followed by a fusion complete with a spinous process plate,~     graft, and a biologic.~   "
194383|NCT01019005|"~     The aim to test whether continues local anaesthetic infusion via tibial catheter or wound~     catheter will improve pain relief following forefoot surgery~      In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing~     forefoot surgery will be randomized into three groups (tibial, wound, control). All groups~     will receive ankle block ± general anesthetic (standard technique). The tibial group will~     have a tibial catheter inserted through which local anaesthetic will be infused. The wound~     group will have a catheter inserted directly into the wound immediately after surgery. The~     control group will have a sham catheter (covered by a bandage across foot) attached to a pump~     which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/~     vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively.~     All groups will be then followed by telephone calls 48 hours. Patients will be instructed to~     come to the clinic on the 4th postoperative day where the catheter will be removed.~   "
194384|NCT01018992|"~     This study will test the hypothesis of whether an antagonist at the corticotropin releasing~     factor type 1 (CRF1) receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of~     post-traumatic stress disorder (PTSD).~   "
194385|NCT01018979|"~     A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell~     mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin~     disease.~   "
194386|NCT01018966|"~     The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of~     ixabepilone in Japanese patients with solid tumors.~   "
194387|NCT01018953|"~     The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's~     overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with~     carcinoid syndrome after 24 weeks of treatment.~   "
194388|NCT01018940|"~     To determine if prasugrel is superior to clopidogrel in providing adequate antiplatelet~     effect in a high risk population that requires concomitant use of a Proton Pump Inhibitor~     (PPI).~   "
194389|NCT01018927|"~     The purpose of this study is to see if MRI techniques can be used for early evaluation of~     cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. Cardiac~     amyloidosis is a medical disorder that decreases heart function.~   "
194390|NCT01018914|"~     To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release~     tacrolimus with Myfortic® in de novo liver transplant recipients.~   "
194391|NCT01018888|"~     The purpose of this study is to evaluate the stability of artificial cornea manufactured by~     Aurolab and to assess its visual outcomes.~   "
194392|NCT01018862|"~     The purpose of this study is to compare the effectiveness of an Investigational use of an~     allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a~     nasal spray that contains no medicine). In addition, the study will also compare the safety~     and effectiveness of an investigational use of another allergy medication (MP03-36) used to~     treat perennial allergic rhinitis to placebo.~   "
194393|NCT01018849|"~     The purpose of this study is to determine if Vitamin D supplementation helps prevent~     recurrent cardiovascular events, such as heart attack or stroke, in patients who have already~     experienced at least one cardiovascular event. This study will investigate if the addition of~     150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a~     subject's medication regimen will prevent further cardiovascular events.~   "
194394|NCT01018836|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as~     riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together~     with whole-brain radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of riluzole when given~     together with whole-brain radiation therapy in treating patients with brain metastases.~   "
194395|NCT01018823|"~     Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2~     Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability,~     pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.~   "
194396|NCT01018810|"~     In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics,~     pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in~     adults with plaque psoriasis.~   "
194397|NCT01018797|"~     To evaluate the clinical outcomes of Intrastromal Corneal Ring Segment (ICRS) implantation to~     correct high-degree astigmatism on eyes with prior penetrating keratoplasty (PK).~   "
194398|NCT01018784|"~     MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks~     as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated~     dose.~   "
194399|NCT01018771|"~     This is a prospective randomised study.~      Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone~     fusion.~      Secondary objectives: Assess clinical outcome measurements.~   "
194400|NCT01018758|"~     This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin~     Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified~     Hesketh classification for antiemetic therapy).~   "
194401|NCT01018745|"~     The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and~     recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when~     administered orally on a once daily schedule in subjects with advanced or metastatic solid~     tumors.~   "
194402|NCT01018732|"~     The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent~     subjects who completed study V59P6 in which they received either Novartis Meningococcal~     (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The~     study will also enroll age-matched subjects who have never received any other meningococcal~     vaccine (naïve subjects) to serve as an additional control group.~   "
194403|NCT01018719|"~     The current study is aimed to evaluate various imaging methods, including multidetector~     computed tomography (MDCT) as potential surrogates to assess the degree of damage caused to~     the heart by radiation therapy to the breast, in breast cancer survivors many years before it~     becomes clinically apparent.~   "
194405|NCT01018693|"~     The purpose of the study is to determine whether VAK694 when combined with subcutaneous~     immunotherapy leads to long term immune tolerance to allergen in individuals with seasonal~     allergic rhinitis.~   "
194406|NCT01018680|"~     The study will test the hypothesis that, in patients with knee pain due to osteoarthritis~     (OA) who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) but still have significant~     knee pain, duloxetine 60 to 120 milligrams (mg) daily for 10 weeks will provide additional~     reduction in pain.~   "
194407|NCT01018667|"~     The ADOPT study is a prospective, nested case-controlled and open label clinical trial. About~     40 centers across China participate in this study with a planned 800 Chinese cases~     enrollment. All patients will receive optimal medical treatment. Patients who have successful~     CRT-P/D implant will be assigned to CRT group. According to the baseline evaluation, matched~     cases will be selected from the enrolled OPT(optimal medical treatment) alone group (Group~     for Selection). After successful match, the cases in Group for Selection enters into~     follow-up and become control group. The unmatched cases in the Group for Selection will be~     removed. If patients agree, after re-evaluation of the baseline situation, she or he may~     enter into Group for Selection again. Since patients know she/he already have a device~     implant and the examiners are aware of the grouping of the patients after seeing the incision~     scar and post-implant electrocardiogram, this study is open-label designed, however the~     executive committee will be kept blind when making event-adjudication. Prospectively defined~     primary end points for the study include combined all-cause mortality and hospitalizations. A~     variety of secondary end points will further define the efficacy and mechanism(s) of action~     of cardiac resynchronization in heart failure. The last date of the study shall be the day~     after 24 months of follow-up of the last enrolled patient. All cases collection complete in~     2010 and study result will be reported in 2012.~   "
194408|NCT01018654|"~     The purpose of this study is to compare a culturally adapted and a non-culturally adapted~     group-based substance abuse treatment with Latino adolescents.~   "
194409|NCT01020708|"~     This Phase I study will be a closely monitored trial of a small number of subjects to~     establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations:~     ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be~     the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the~     comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of~     study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same~     assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive~     ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9~     patients will be enrolled in this study, allowing for up to 3 replacement or additional~     patients.~   "
194410|NCT01020487|"~     Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg~     paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney~     disease (CKD Stages 3 and 4).~      Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo~     in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with~     moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study~     drug followed by a minimum of 12 weeks of open-label active drug.~   "
194411|NCT01020383|"~     This is a multicenter, randomized and open-label Phase II study to compare the safety,~     tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro®~     in high risk PCI patients.~      Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and~     heparin. Eligible patients will be randomly assigned to receive open-label study treatment~     with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective~     or ad-hoc) and stent type (bare metal stent or drug eluting stent).~   "
194412|NCT01020292|"~     This phase I trial will determine safety, dose-limiting toxicities (DLT) and maximum~     tolerable dose (MTD) of the protease inhibitor, Nelfinavir (NFV), when given with~     chemoradiotherapy as post-operative therapy for glioblastoma multiforme (GBM). Oral NFV is a~     standard therapy for patients with HIV and the safety of 1250 mg BID NFV is well-established.~     Case studies have also reported that HIV patients have received radiotherapy for cancer,~     while on 1250 mg BID NFV. This is the first trial of oral NFV and chemoradiotherapy for GBM~     patients. Although unacceptable toxicity is unlikely, two NFV dose levels (625, and 1250 mg~     BID) will be evaluated in a cohort escalation design of 3-6 subjects. At the MTD, 19~     additional subjects will be enrolled to generate pilot data on radiographic response and to~     evaluate further toxicity. A maximum of 31 subjects will be enrolled on the trial.~   "
194413|NCT01020097|"~     Rationale: Diagnostic procedures, such as positron emission tomography, using the drug~     fluorine F 18-EF5 to find oxygen in tumor cells may help in planning cancer treatment.~      Purpose: This clinical trial studies fluorine F 18-EF5 positron emission tomography in~     assessing hypoxia in patients with newly diagnosed stage I, stage II, stage III, or stage IV~     squamous cell cancer of the oral cavity, oropharynx, and larynx.~   "
194414|NCT01019954|"~     This is a study to evaluate the safety and find the highest tolerable dose of Levulan® and~     Photodynamic Therapy (PDT) for premalignant tumors of the head and neck. Subjects will~     receive Levulan® by mouth and will undergo PDT. Levulan® goes throughout the body, but gets~     retained in cancer cells more than non-cancer cells. After 4-6 hours, the targeted area is~     treated with laser light which activates the Levulan® to kill the cells that contain it.~   "
194415|NCT01019512|"~     RATIONALE: The Flexitouch lymphedema system may lessen lymphedema caused by treatment for~     breast cancer. It is not yet known whether the Flexitouch lymphedema system is more effective~     than complex decongestive therapy in treating lymphedema. PURPOSE: This randomized clinical~     trial is studying the Flexitouch lymphedema system in treating stage II lymphedema in~     patients with breast cancer.~   "
194416|NCT01019278|"~     RATIONALE: Specialized radiation therapy, such as proton beam radiotherapy, that delivers a~     high dose of radiation directly to the tumor may kill more tumor cells and cause less damage~     to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving proton beam radiation therapy~     together with cisplatin works in treating patients with stage IB, stage II, stage III, or~     stage IVA cervical cancer and positive lymph nodes.~   "
194674|NCT01015287|"~     The purpose of this trial is to investigate the potential benefits/risks regarding~     pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants~     with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention~     (PCI).~   "
194417|NCT01019187|"~     RATIONALE: Sleep disorder counseling may reduce fatigue and insomnia as well as improve the~     well-being and quality of life of cancer survivors. Armodafinil may help relieve insomnia and~     fatigue in patients with cancer after chemotherapy. PURPOSE: This randomized phase II trial~     is studying how well cognitive behavioral therapy with or without armodafinil works in~     treating cancer survivors with insomnia and fatigue after chemotherapy.~   "
194418|NCT01019122|"~     In 2003, observational growth and bone density data was obtained on children with cerebral~     palsy (CP) living at Hattie Larlham as part of a study comparing growth with an existing~     database of children with CP who live at home. The original residents included in that study~     are now of adult age. Due to the lack of longitudinal bone density measurements in~     facility-based adults with severe CP, the investigators' objective is to obtain 6-year~     follow-up data from the residents enrolled in the original study.~   "
194419|NCT01018901|"~     RATIONALE: Gathering information about survivors of prostate cancer and their partners may~     help doctors learn more about the goals for sexual functioning after cancer treatment.~     PURPOSE: This clinical trial is studying the goals of sexual functioning in prostate cancer~     survivors and their partners after cancer treatment.~   "
194420|NCT01018875|"~     Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.~   "
194421|NCT01018641|"~     This study is a first-in-human (Phase 1) study using three dose levels of an investigational~     vaccine directed against Staphylococcus aureus (SA3Ag). This study is primarily designed to~     assess how safe and well tolerated SA3Ag is, but will also describe the immune response over~     12 months elicited by SA3Ag. Additionally, this study will assess the effect of SA3Ag vaccine~     on the number of Staphylococcus aureus bacteria that naturally occur on the skin and within~     the nose and throat.~   "
194422|NCT01018628|"~     The main purpose of this study is to assess the safety and pharmacokinetics of SRT2379 (25,~     75, 250, 500, 1000, 2000, and 3000 mg/day [fasted] and 500 mg/day [fed]) in healthy male~     volunteers.~      The purpose is also to explore the effect of SRT2379 on plasma concentrations of Fibroblast~     Growth Factor 21 (FGF21) and to identify other possible biomarkers suitable for future~     clinical assessment of oral SIRT1 activators.~   "
194423|NCT01018615|"~     The purpose of this study is to determine if the safety, metabolism, and antioxidant activity~     of silymarin and green tea extract are changed when they are given in combination to patients~     with chronic hepatitis C infection.~   "
194424|NCT01018602|"~     The aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily~     dose of 100 mg in scope of the development of type 2 diabetes in women with insulin dependent~     gestational diabetes in their last pregnancy not longer than 9 months after birth.~      In this randomized, placebo-controlled, double-blinded clinical phase II study, 140~     participants aged 18 years or older and an insulin dependent gestational diabetes in their~     last pregnancy should be included and treated with vildagliptin or placebo over 24 months,~     followed by a 12 months observation period. Exclusion criteria are pregnancy and lactation as~     well as a clinical overt diabetes or islet autoimmunity.~      The null hypothesis is that there is no significant difference of diabetes incidence~     (according to ADA criteria 1997) in both groups.~      Primary endpoint is the clinical manifestation of diabetes, secondary endpoints include the~     improvement of beta cell function (evaluable by C-peptide measurement) and of insulin~     sensitivity by the treatment with vildagliptin.~   "
194425|NCT01018589|"~     The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort)~     usage in the treatment of epidermic burns or post surgical scars. The duration of this phase~     2 clinical trial will be two months.~   "
194426|NCT01018576|"~     Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of~     premature infants. However this procedure is not standard due to concerns that the premature~     infant will get too cold. In this study the investigators look at using a plastic covering~     and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to~     clamp the umbilical cord.~   "
194427|NCT01018563|"~     An open label extension of the MORAb-003-002 study in order to continue the active patients~     in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.~   "
194428|NCT01018550|"~     The primary objective is to determine if AMG 853 is effective compared with placebo as~     measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from~     baseline to week 12.~   "
194429|NCT01018537|"~     This project is based on the idea that we can learn about the complexities of MS by following~     disease and treatment patterns in a large group of people over several years. The information~     gathered is used for research only. Results are presented in summary form only. All details~     submitted by registry participants is strictly confidential.~      To participate in NARCOMS complete the baseline enrollment survey online through~     www.narcoms.org (or directly using the following link: http://j.mp/2jJm5lK) or you can~     request a mail-in survey be sent to you by emailing MSregistry@narcoms.org. You will be asked~     to update your information, online or by mail, twice a year. Each update survey typically~     takes less than 20 minutes to complete.~      There is no cost to participate. For your participation you are offered a free subscription~     to the NARCOMS quarterly magazine, NARCOMS Now. NARCOMS Now provides a reliable source of~     information about the latest in MS research and disease management. You can stop~     participating in the registry at any time.~      You may also receive additional surveys or information on clinical trials. You are not~     obligated to participate and these additional studies will always come directly from NARCOMS.~     Your contact information will not be shared or sold to other parties.~   "
194430|NCT01018524|"~     The purpose of this study is to:~        1. compare the long term results of mesh versus suture repair in treatment of abdominal~          wall defects;~        2. find the optimal location of implanted prosthesis, comparing the two most useful~          position of mesh in abdominal wall hernia surgery.~   "
194431|NCT01018511|"~     Clinical study to examine the efficacy, safety and tolerability of combination therapy of~     tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin~     hydrochloride in the treatment of males with LUTS associated with BPH with a substantial~     storage component.~   "
194534|NCT01017159|"~     The purpose of this study is to determine whether subcutaneous immunoglobulin given in small~     doses, is effective in maintaining the force, in patients with chronic inflammatory~     demyelinating polyradiculoneuropathy compared with placebo (saline infusions), and~     intravenous immunoglobulin.~   "
194432|NCT01018498|"~     Malabsorption of certain foods (e.g. lactose) has been proposed as a cause of irritable bowel~     syndrome in adults and children. Recently, a diet that lowers intake of a combination of~     foods has been found to be effective in adults with IBS identified with fructose~     malabsorption.~      The purpose of this study is to determine whether a restricted fermentable substrate diet is~     effective in the treatment of irritable bowel syndrome in children.~   "
194433|NCT01018485|"~     The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds~     of patients. Over half of the tremors involve the upper limb and frequently lead to further~     disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine,~     clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and~     tetrahydrocannabinol have been reported to have some beneficial effect but published evidence~     of effectiveness is very limited. The investigators' experience to date suggests that many of~     the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy.~      Aims:~      1. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the~     patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects~     associated with this treatment.~   "
194434|NCT01018472|"~     Infants with congenital heart disease have more frequent infections and exposures to~     antibiotics than healthy infants. It is unknown how congenital heart disease affects the~     development of bacterial colonization of the intestines. It is also unknown whether~     probiotics will change the bacteria in the intestine of infants with heart disease to become~     more like those of healthy infants without heart disease. This pilot trial is designed to~     address these two questions.~   "
194435|NCT01018459|"~     The purpose of this study is to evaluate the safety of a malaria vaccine, Ad35.CS.01, and how~     the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and~     females ages 18-45 years in Burkina Faso. Volunteers for this study will be divided into 4~     groups. Members of each group (12 per group) will receive an increasing dose of vaccine or~     placebo (an inactive substance). Ten will receive the malaria vaccine and 2 will receive~     placebo. Study procedures include: physical exam, urine sample, and blood samples.~     Participants will be involved in study related procedures for about 13 months.~   "
194436|NCT01018446|"~     In this study the investigators plan to develop a method to determine optimal busulfan dose~     through pharmacokinetic study.~   "
194437|NCT01018433|"~     The purpose of this study is to investigate an intervention specifically for non-suicidal~     self-injury (NSSI) in young adults. The goal of this 9-session outpatient intervention is to~     reduce the frequency and severity of NSSI. During Phase I, 12 patients will be treated in an~     open pilot trial. During Phase II, 60 patients will be treated in a randomized controlled~     pilot study in order to determine the feasibility and acceptability of the intervention and~     to investigate change in NSSI frequency and severity over time.~   "
194438|NCT01018420|"~     This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen~     of 4.8 mg over 6 hours. In addition it will compare the electrocardiogram (ECG) changes, if~     any, from this dosing regimen to that of a single dose of moxifloxacin 400 mg, a positive~     control for the corrected QT interval (QTc) prolongation.~   "
194439|NCT01018407|"~     The goal of this project is to compare the efficacy of two interventions for improving spoken~     language and reducing symptoms of autism.~   "
194440|NCT01018394|"~     Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the~     risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking~     reduction increases smoking abstinence among smokers not interested in quitting. The~     overarching goal of this line of research is to develop a ST reduction intervention among ST~     users not interested in quitting tobacco. Our first step is to conduct the proposed pilot~     study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for~     reducing ST use or facilitating ST abstinence among ST users not interested in quitting.~   "
194441|NCT01018381|"~     Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide with an estimated~     626,000 new cases per year worldwide, accounting for 5.7% of new cancer cases. Although~     resection and transplantation offer the best 5-year survival rates, not all patients are~     suitable surgery candidates. Other treatments include pericutaneous ethanol injection (PEI),~     radiofrequency ablation (RFA), and transarterial oily chemoembolization (TOCE), all of which~     enhance the survival rate and aid in shrinkage of the tumor. The very low survival rate among~     HCC patients, 3-5%, reflects the inadequacy of conventional therapies for the disease and~     highlights the necessity of finding new treatments or modifying the current treatment.~      The hepatitis B virus (HBV) causes liver disease that can range in severity from a mild~     illness that lasts several weeks (acute hepatitis B) to a long-term chronic illness. An~     estimated 2 billion people have been infected with HBV worldwide, resulting in more than 350~     million individuals with chronic, long-term liver infections. Patients with chronic HBV~     infection are at a great risk for the development of cirrhosis, hepatic failure, and HCC.~     There is no cure for hepatitis B and care is mostly palliative. There are several anti-viral~     and interferon drugs, such as Entecavir and Interferon α therapy, which can help some~     patients. However, these drugs are costly, thousands of dollars per year, and are not widely~     available in many countries, especially in the developing world. Vaccination is available and~     effective and is recommended for all individuals at risk for HBV infection. However,~     vaccination is only effective in individuals who have not been exposed to HBV. Hepatitis B is~     closely linked to liver cancer, which is almost always fatal.~      MGN-3/Biobran is an arabinoxylan extracted from rice bran that is treated enzymatically with~     an extract from Shiitake mushrooms. MGN-3 demonstrated anti-cancer activity in vivo in mice~     and humans. The present study was carried out to examine whether combining the current~     conventional treatment with a food supplement, arabinoxylan rice bran (MGN-3/Biobran), may~     improve the outcome of the disease and increase the survival rate of patients with HCC or~     HBV. We hypothesize that a combinatory treatment of conventional therapy with MGN-3/Biobran~     will augment the therapeutic effect seen when patients are treated with conventional therapy~     alone.~   "
194442|NCT01018368|"~     The objectives of this study are to evaluate the effects of multiple doses of rifampin on the~     single-dose pharmacokinetics of VX 770.~   "
194443|NCT01018355|"~     The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet~     medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA)~     when compared to antiplatelet medical management alone in elderly patients above 50 years of~     age with a PFO and a history of cryptogenic stroke or TIA.~   "
194444|NCT01018342|"~     The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin~     monohydrate/macrocrystals capsules to Procter & Gamble Macrobid® capsules following a single,~     oral 100 mg (1 x 100 mg) dose under fed conditions.~   "
194445|NCT01018329|"~     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging, may help doctors~     predict a patient's response to treatment and help plan the best treatment. PURPOSE: This~     clinical trial is studying magnetic resonance imaging in response to radiation therapy in~     patients with high grade glioma.~   "
194446|NCT01018316|"~     The UMOX is a device that has been designed as an alternative to the conventional face mask~     for preoxygenation to be used when an optimal preoxygenation with a facemask is difficult to~     achieve(i.e: when a leak is present. A previous study in our hospital (unpublished data) has~     shown that the UMOX was only as effective as the conventional mask when a nose clip was used~     to prevent the patients from breathing in some air through the nose, thus preventing the~     dilution/contamination of the 100% oxygen delivered.In that study, the verbal indication~     giving to the subjects to breathe through the mouth was better than no indication at all but~     still yielded unsatisfactory results.~      For this reason, the present study was designed to verify the hypothesis that while using the~     UMOX for preoxygenation, the verbal indication of breathing 8 vital capacity breaths added to~     the indication of breathing through the mouth would bring equivalent results -measured by the~     expired fraction of oxygen- as a preoxygenation of normal tidal breathing through a facemask~     during 3 to 5 minutes.~      Preoxygenation was performed with the 60 volunteers placed in the supine position with 100%~     oxygen. All volunteers went though preoxygenation with two techniques: 1) breathing normal~     tidal volumes at a normal respiratory rate for a period of 5 minutes through a tight fitting~     conventional face mask, and 2) eight deep breaths (i.e. vital capacity breaths) through the~     UMOX device with verbal indication to use only the mouth to breathe.~   "
194447|NCT01018303|"~     The purpose of this study is to test the safety and efficacy of the final commercial~     formulation of an antioxidant enriched multivitamin supplement in softgel capsule form~     (AquADEKs) in increasing the plasma levels of certain nutrients and antioxidants in~     individuals with cystic fibrosis.~      Hypothesis: An oral antioxidant-rich multivitamin supplement (AquADEKs), which uses a~     Generally Regarded As Safe (GRAS) molecule to form micelle-like vehicles, will safely~     increase systemic levels of beta-carotene, coenzyme Q10, and gamma-tocopherol, decrease~     PIVKA-II levels, while maintaining levels of vitamins A and D in the normal range in persons~     with CF > 10 years of age.~   "
194448|NCT01018290|"~     Maximizing surgical removal of brain tumors while minimizing neurologic deficits is~     challenging. Functional brain tissue may reside close to or even within the abnormality, and~     inadvertent removal or disturbance of such areas can result in neurologic deficits. At~     present, the gold standard for identifying critical motor areas in tumor surgery is~     intraoperative invasive direct current stimulation (DCS) through a handpiece. More recently,~     new non-invasive preoperative method for brain mapping, functional magnetic resonance imaging~     (fMRI), may be used to identify the eloquent motor areas. fMRI signals used in localization~     of the motor areas are generated when the brain is activated during the performance of~     specific motor tasks. However, as fMRI signals are also generated by sensory input, the~     resulting fMRI map may include sensory as well as motor areas.~      Nexstim has developed a Navigated Brain Stimulation (NBS) system that uses TMS with a~     software based Navigational System that together may have more specific spatial accuracy.~      This study aims to determine whether navigated TMS is able to identify the eloquent motor~     cortical areas in patients with brain tumors and to determine the clinical accuracy of the~     procedure by comparing it to results obtained by intraoperative DCS and fMRI.~   "
194449|NCT01018277|"~     Aim of the present study is twofold.~        -  First we want to evaluate the effect of mobilization on acute postoperative pain~        -  Second to test weather chances in pain sensitivity are occurring following surgery and~          mobilization after total knee arthroplasty~   "
194450|NCT01018264|"~     This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing~     symptoms of overactive bladder in Parkinson's disease (PD) patients.~   "
194451|NCT01018251|"~     This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast~     cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to~     treatment. We will compare this technique with other imaging modalities as well as with~     tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive~     breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,~   "
194452|NCT01018238|"~     This trial is conducted in the United States of America (USA). The aim of this clinical trial~     is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of~     increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus~     (SLE).~   "
194453|NCT01018225|"~     The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of~     moderate to severe nocturia in patients with overactive bladder and who do not have~     non-urologic causes of nocturia.~   "
194454|NCT01018212|"~     The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort)~     usage in the treatment of cutaneous grooves. The duration of this phase 2 clinical trial will~     be 4 months.~   "
194455|NCT01018199|"~     In this study the investigators aim to test if C-reactive protein (CRP) or procalcitonin(PCT)~     - guided strategy allows to reduce the antibiotic use in patients wiht community-acquired~     pneumonia. Therefore, the safety of this intervention will be carefully measured.~   "
194456|NCT01018186|"~     The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444~   "
194457|NCT01018173|"~     This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and~     safety and the effects of taspoglutide on cardiovascular events in patients with inadequately~     controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be~     randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks~     followed by 20mg sc weekly, or weekly sc placebo, in addition to background~     anti-hyperglycemic medication and standard of care treatment for cardiovascular disease.~     Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.~   "
194458|NCT01018160|"~     The purpose of this study is to examine the treatment profile of approximately 1,000 adult~     patients with gastroesophageal reflux who begin raberpazole sodium treatment for 4 months,~     and assess patients' adherence to the study drug.~   "
194500|NCT01017601|"~     RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells~     without damaging normal cells. It is not yet known whether NTX-010 is more effective than a~     placebo in treating small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared~     with a placebo when given after chemotherapy in treating patients with extensive-stage small~     cell lung cancer.~   "
194459|NCT01018147|"~     This clinical trial studies 4-dimensional (4-D) image-guided radiation therapy treatment~     planning in patients with stage I-IV non-small cell lung cancer. Computed tomography (CT)~     scans and treatment-planning systems may help in planning radiation therapy for patients with~     non-small cell lung cancer. This is not a therapy study. Therefore no direct benefit from~     participating is expected. However, at the discretion of the treating physician, the~     information gained from the additional imaging will be used to improve treatment accuracy. No~     patient outcome data are gathered or analyzed by this study. This study is not a:Phase I, II,~     or III trial, trial with blinded treatment arm, gene or a vaccine trial, or a~     multi-institutional trial.~   "
194460|NCT01018134|"~     The objectives of this study are to evaluate the efficacy and safety of two dosing regimens~     of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients~     with moderate to severe plaque psoriasis.~   "
194461|NCT01018121|"~     The objective of this project is to pilot test a behavioral intervention for modifying the~     diet and physical activity patterns of overweight preschool children through improved~     parenting and nutritional education(LAUNCH). This intervention will be compared to standard~     of care for preschool overweight in the primary care setting using a randomized clinical~     trial design (RCT. The results of this pilot RCT will provide data integral to estimating the~     effect size for a more definitive RCT of the intervention in the future. The primary~     hypothesis is:~      H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the~     standard of care at 12 months post-treatment.~   "
194462|NCT01018108|"~     RATIONALE: New imaging procedures, such as single photon emission computed tomography, may~     help in learning how acupuncture affects serotonin levels in the brain of breast cancer~     survivors. PURPOSE: This phase I trial is studying the best way to visualize the effect of~     acupuncture on brain serotonin in breast cancer survivors.~   "
194463|NCT01018095|"~     The purpose of this study is to determine if the 2 gram single dose of metronidazole is as~     effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among~     HIV-infected women.~   "
194464|NCT01018082|"~     The overall goal of this 2-year pilot project is to utilize interdisciplinary strategies to~     determine the prevalence and type of neurodevelopmental impairment in PHACE syndrome, a rare~     vascular syndrome, and to rapidly translate discovery into clinical care guidelines that will~     identify at risk infants so early intervention can be initiated. Infantile hemangioma is the~     most common benign tumor of infancy, with an incidence estimated between 4-5%. A subgroup of~     patients with infantile hemangiomas exhibits additional associated structural anomalies of~     the brain, cerebral vasculature, eyes, aorta, heart, and chest wall in the rare~     neurocutaneous disorder called PHACE syndrome (OMIM 606519). PHACE refers to Posterior fossa~     anomalies, Hemangioma, Arterial lesions, Cardiac abnormalities/aortic coarctation, and~     abnormalities of the Eye. Affected children have multi-organ involvement, and an increasing~     number of cerebral, cerebellar, and cerebrovascular anomalies are being described; however,~     the significance of these neuroradiologic findings is not known. As the investigators'~     neonates with hemangiomas have grown into young children, neurodevelopmental impairment has~     become more evident, even among patients without MRI evidence of stroke or structural brain~     anomalies. Some infants develop progressive cerebral arterial disease leading to a~     moyamoya-like vasculopathy and ischemic stroke. An interdisciplinary research project~     studying brain and cerebral vascular imaging in concert with neurological, psychological,~     behavioral, neurodevelopmental, and quality of life outcome measures has never been~     conducted. Diagnostic and management guidelines are also lacking. The investigators'~     long-term goal is to develop medical and/or surgical therapeutic interventions that improve~     the overall health of children with PHACE syndrome. This novel project constitutes the first~     study of the most devastating feature of PHACE syndrome: the neurodevelopmental sequelae.~   "
194465|NCT01018069|"~     To determine if AEG35156 can enhance the combined complete remission (CR) and CR with~     incomplete platelet recovery (CRp) rate of high-dose cytarabine and idarubicin in AML~     following failure of a single standard dose cytarabine based frontline induction regimen.~   "
194466|NCT01018056|"~     A joint NIH -Tourette Syndrome Association Conference has emphasized the critical need for~     the testing and development of new pharmacotherapy for tic suppression in Tourette syndrome~     (TS). This submission is a safety, tolerability and efficacy pilot study using two~     medications that modulate glutamate neurotransmission, riluzole, a glutamate antagonist, and~     D-serine, a glutamate agonist. Glutamate is the primary excitatory neurotransmitter in the~     central nervous system, an essential component of pathways implicated in TS and an extensive~     modulator of dopamine, the major neurotransmitter associated with tics.~      This is a single site, short-term, proof of concept study of riluzole and D-serine for the~     treatment of tics. Each medication will be evaluated and compared to placebo as part of a~     double-blind, randomized, parallel, flexible dose, three-arm, 8-week, treatment protocol~     (D-serine, riluzole, or placebo). A total of sixty patients (age 8-17 years) with TS and~     moderate to moderately-severe tics will receive study medication according to a 2:1 (dopamine~     modulating drug: placebo), randomized schedule, i.e., riluzole (n=24), D-serine (n=24),~     placebo (n=12). The primary outcome measure is tic suppression as determined by changes in~     the Total Tic Subscore of the Yale Global Tic Severity Scale (YGTSS). Secondary tic outcome~     measures include changes in the YGTSS Total Score and two Global Impression Scales. Further,~     since both riluzole and D-serine have been proposed as treatments for obsessive-compulsive~     behaviors, a TS co-morbidity, these symptoms will be followed. Safety measures include serial~     physical examinations, vital signs, laboratory studies (comprehensive metabolic panel,~     complete blood count, plasma amino acids, and urine analyses), documentation of side effects~     and adverse events, and measurement of changes in ADHD, depression and anxiety.~      This pilot investigation will provide important proof-of-concept data on glutamate therapies~     for TS and, in turn, evidence for large-scale, multi-center clinical trials.~   "
194467|NCT01018043|"~     The purpose of this study is to create a large Thailand database documenting the severity of~     anemia and its management in the cancer population.~   "
194468|NCT01018030|"~     The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal~     spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent~     subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).~   "
194484|NCT01017822|"~     RATIONALE: Monoclonal antibodies, such as conatumumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy~     may uses high energy x-rays to kill tumor cells. Giving conatumumab together with gemcitabine~     hydrochloride, capecitabine, and radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of conatumumab when~     given together with gemcitabine hydrochloride, capecitabine, and radiation therapy and to see~     how well they work in treating patients with locally advanced pancreatic cancer.~   "
194485|NCT01017809|"~     The investigators propose to totally abolish the emesis (vomiting) associated with the~     regimen of oxaliplatin + topotecan by adding a daily administration of aprepitant (Emend) for~     17 days to the HT3 blocker routinely given on days 1 and 15.~   "
194535|NCT01017146|"~     The purpose of this study is to assess safety and efficacy of a new foam formulation of~     tazarotene in subjects with acne vulgaris.~   "
194469|NCT01018017|"~     Randomized, placebo-controlled, parallel-group, double-blind, multiple-dose, activity and~     safety clinical study of SRT2104 administered orally once daily for 28 consecutive days. This~     will be an inpatient/outpatient study to assess the safety and pharmacokinetics of SRT2104 in~     type 2 diabetic male and female subjects on an existing, stable, background metformin~     therapy. Approximately 80 subjects will be enrolled. Subjects will be evenly randomized to~     receive SRT2104 2.0 g/day or placebo in the fed state.~      Subjects will be required to stay overnight at the study center on Days -2, -1, 0, 1~     (optional discharge at investigator's discretion), 27, 28, 41, and 42. During these~     admissions, pharmacokinetic, biomarker and glycated albumin samples will be collected, and~     glucose profiling, OGTT, glucose stabilization, hyperinsulinemc euglycemic clamp (HEGC)~     studies with indirect calorimetry and various other safety and activity procedures will be~     performed. On Day 1 of the study, subjects will be randomized to receive SRT2104 or placebo.~     Day 43 will be the last day of the study and subjects will be released. In addition, subjects~     will be asked to return to the study center on Day 14 for interim safety assessments.~      During the dosing period, study personnel will contact subjects by telephone on Days 7 and 21~     to conduct a safety assessment. Subjects will be required to monitor their fasting blood~     glucose and complete a daily diary for the outpatient portion of the study between Days 1 and~     28. A follow-up, safety phone call will occur 30 days following their final dose of SRT2104~     or placebo (Day 58 of the study) to identify any possible additional adverse events or~     concomitant medications.~   "
194470|NCT01018004|"~     RATIONALE: Gathering information over time from follow-up visits may help doctors plan the~     best follow-up schedule. It is not yet known which follow-up schedule is more effective in~     improving patient quality of life.~      PURPOSE: This randomized clinical trial is comparing follow-up schedules to see how well they~     work in patients with newly diagnosed stage IB or stage II melanoma.~   "
194471|NCT01017991|"~     The purpose of the study is to assess if infants who have excessive crying and fussing have~     less of these symptoms when fed a formula containing a probiotic compared to those fed a~     standard infant formula.~   "
194472|NCT01017978|"~     To determine if MRI imaging can be used to accurately determine if a sarcoma is responding to~     the type of chemotherapy being used.~   "
194473|NCT01017965|"~     The objective of this study is to assess the impact of objective sleep duration on blood~     glucose control in type 1 diabetes adult patients.~      This study will also evaluate the impact of objective sleep duration on blood pressure over a~     24-hour period and the impact of objective sleep duration on quality of life.~      Last, it will investigate the influence of objective physical activity duration on blood~     glucose control, blood pressure and quality of life.~   "
194474|NCT01017952|"~     The Purpose of this study is to assess the efficacy and safety of three strengths of the~     FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)~   "
194475|NCT01017939|"~     The purpose of this study is to evaluate the effects of multiple doses of abiraterone acetate~     plus prednisone on the pharmacokinetics (study of what the body does to a drug) of single~     doses of dextromethorphan hydrobromide and theophylline in patients with castration resistant~     prostate cancer.~   "
194476|NCT01017926|"~     The purpose of this study is to compare the bioavailability of two oral formulations of~     Triazolam in healthy volunteers, in order to determine that they are bioequivalent.~   "
194477|NCT01017913|"~     The purpose of this study was to compare the effects of the TENS and IFC in patients with non~     specific chronic low back pain.~   "
194478|NCT01017900|"~     This study objectives are to compare the efficacy and safety between surgical excision and~     manual rupture for dorsal carpal ganglion.The participants with dorsal carpal ganglion will~     be randomized into 2 groups:surgical excision or manual rupture.The patients will be~     follow-up for at least 1 yr.Telephone interview will be used for outcome assessment.~   "
194479|NCT01017887|"~     The new AirSeal access port for laparoscopic surgery does not use a mechanical valve on the~     port to maintain gas in the peritoneal cavity. It uses an invisible barrier created by high~     flow gas jets within the port. The percentage of carbon dioxide, the standard gas used for~     laparoscopy, during laparoscopic surgery has not been previously measured, but is probably~     high. The investigators aim to measure the percentage of intraperitoneal carbon dioxide with~     standard ports and the AirSeal port during a variety of conditions during laparoscopic~     procedures including suturing and suctioning. The study period will commence at the start of~     the operation, and be completed upon discharge from the hospital or postoperative day 5,~     whichever is shorter. All devices are approved for use in humans by the FDA, and are being~     used for their intended purpose.~   "
194480|NCT01017874|"~     The purpose of this study is to compare two different approaches to treating non-small cell~     lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will~     receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib)~     and the other half of the participants will receive only the oral anti-cancer agent~     (gefitinib).~   "
194481|NCT01017861|"~     Recent studies have shown that women are more likely to experience pain in many medical~     situations. During pregnancy, women may experience an increase in pain threshold. This is~     thought to be related to hormonal changes and an increase in the level of certain natural~     pain-relieving substances in their bodies.~      It is important to develop simple tests to identify woman at higher risk for pain so the~     investigators can help them.~      Temporal summation is what happens when a person becomes more sensitive to a certain feeling~     on their skin when it is applied several times over the course of several seconds. The~     investigators hypothesize that pregnant women show decreased temporal summation and pain~     scores to venipuncture, compared to non-pregnant women.~   "
194482|NCT01017848|"~     Urine pH has been lately linked to insulin resistance. The early phase of Diabetes Mellitus~     involves insulin resistance. Thus, the investigators want to check if a simple cheap study~     like a urine analysis that can predict diabetes.~   "
194483|NCT01017835|"~     The purpose of this study is to determine whether combined therapy with simvastatin and~     hypotensive drugs (ACEI or ARB) may decrease the blood pressure. Moreover, we would like to~     assess the influence of isolated hypertension on endothelial injury, and on the development~     of atherosclerosis.~   "
194486|NCT01017796|"~     The use of N-acetylcysteine and ascorbic acid reduce the incidence of radiographic contrast~     agent induced reduction in renal function in Intensive Care Unit patients.~   "
194487|NCT01017783|"~     The primary objectives of this clinical trial are to determine if replacing sugar sweetened~     beverages with water consumption promote weight loss over 6 months in overweight adults and~     if replacing sugar sweetened beverages with water consumption promote greater weight loss~     over 6 months relative to replacement with other non-caloric sweetened beverages or control.~      The secondary objective is to identify mediators and moderators of the effect of water~     replacement including hydration status, glucose metabolism, anthropometrics, physical~     activity, dietary intake and resting metabolic rate.~   "
194488|NCT01017770|"~     Several countries in Africa have changed their first-line treatment for uncomplicated malaria~     to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and~     Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local~     effectiveness of these drugs when they are given to patients in real life conditions, without~     direct observation of the drug administration. Thus, this study aims at investigating the~     effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina~     Faso.~   "
194489|NCT01017757|"~     Immunosuppressive drugs such as tacrolimus, cyclosporine, mycophenolate mofetil, sirolimus~     and everolimus may have toxic pulmonary effects, particularly interstitial alterations. The~     aim of the present study is to explore the presence of subclinical interstitial lung~     abnormalities in stable renal transplant recipients taking the different immunosuppressive~     drugs used as maintenance therapy for renal transplantation.~   "
194490|NCT01017744|"~     Sevoflurane inhalational anesthetic has got pulmonary effects such as bronchodilatation.~     These effects could be of interest in intensive care patients ventilated in pressure support~     ventilation mode. The purpose of this study is to evaluate mechanical respiratory effects of~     sevoflurane administered through a new specific heat and moister exchanger called the~     Anesthetic Conserving Device (AnaConDa®) in pressure support ventilation in intensive care~     patients. In fact, dead space and resistance generated by the device could cancel and even~     deteriorate the potential positive effects of sevoflurane on ventilation.~   "
194491|NCT01017731|"~     The purpose of this study is to determine if Ramucirumab (IMC-1121B) causes prolongation of~     the QT/QTc interval in participants with advanced cancer.~   "
194492|NCT01017718|"~     The investigators intend to study children and adolescents from 8 to 18 years suffering from~     diabetes mellitus type 1 for more than one year. The patients will undergo a detailed~     clinical examination for anthropometric data, blood pressure, blood and urine. Motor and~     sensory nerve conduction velocity will be examined by electrical stimulation using surface~     patch electrodes. The nerves to be examined are the nervus tibialis anterior, nervus medianus~     and nervus peroneus.~      Primary outcome:~      How many children and adolescents suffering from diabetes mellitus type 1 (duration of~     disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d) show pathological nerve~     conduction velocity?~      Secondary outcome:~      Is there a significant difference in nerve conduction velocity between the group of diabetic~     patients and the control group of healthy young people? Does the quality of disease control~     have an influence on nerve conduction velocity? Is there a correlation between nerve~     conduction velocity in our study patients and the Young Score? Is there a correlation between~     pathological nerve conduction velocity and other long-term vascular complications~     (nephropathy, retinopathy)?~   "
194493|NCT01017692|"~     The objective of this study is to establish a relationship between the degree of~     radiologically established anatomical stenosis and the severity of self-assessed outcome~     measures in patients that have undergone and MRI.~   "
194494|NCT01017679|"~     This is a multi-center phase II randomized controlled study to assess the efficacy of~     Gefitinib 500mg in patients with IIIB/IV staged non-small cell lung cancer(NSCLC) with stable~     disease after a month treatment of 250mg Gefitinib by DCR,also PFS and OS.The side effect is~     evaluated as well.~   "
194495|NCT01017666|"~     The purpose of this study is to understand whether BIIB014 has potential to affect how~     certain drugs are broken down by the body.~   "
194496|NCT01017653|"~     This is a phase II study of the combination of panitumumab with irinotecan in malignant~     glioma patients. The primary objective of the study is to determine the activity of the~     combination of panitumumab with irinotecan as measured by 6-month progression-free survival.~     Secondary objectives include the following- to determine the safety of panitumumab in~     combination with irinotecan in patients with malignant glioma; to determine the effect of~     panitumumab in combination with irinotecan on corticosteroid dose for each patient; to~     explore any relationship between epidermal growth factor receptor (EGF-R) mutational analysis~     and efficacy or toxicity; and, to determine the response rate and overall survival of~     recurrent glioblastoma (GBM) patients treated with panitumumab in combination with~     irinotecan.~      The patients will have histologically documented grade 4 malignant gliomas (glioblastoma~     multiforme or gliosarcoma) that have failed at least one prior chemotherapy regimen and all~     patients will have received radiation therapy. This study will investigate second or greater~     line of therapy for recurrent grade 4 malignant glioma. The patient population will include~     32 patients.~      The patients will undergo a baseline magnetic resonance imaging (MRI) as well as a MRI after~     every six-week cycle to determine response and progression. After 16 patients with recurrent~     GBM are treated, an interim analysis will be conducted. The most common side effects~     associated with panitumumab have been dermatological (skin) problems such as erythema~     (redness of the skin), acneiform rash (skin eruptions of the face), skin exfoliation,~     pruritus (itching), skin fissures (skin tears), xerosis (dryness of the eye, skin, or mouth),~     and rash. The most common side effects associated with irinotecan have been decreased blood~     counts of platelets (increased risk of bleeding), white blood cells (increased risk of~     infection), red blood cells (anemia); diarrhea, constipation, nausea, vomiting, tiredness,~     fever, mouth sores, dehydration (excessive loss of body fluids), rash, itching, changes in~     skin color, swelling, numbness, tingling, dizziness, confusion, low blood pressure, sweating,~     hot flashes, hair loss, inflammation of the liver, flu-like symptoms, decreased urine output,~     shortness of breath, and pneumonia (inflammatory disease of the lungs).~   "
194497|NCT01017640|"~     This phase I trial studies the side effects and best dose of veliparib when given with or~     without mitomycin C in treating patients with solid tumors that have spread to other places~     in the body, cannot be removed by surgery or have come back. Veliparib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as mitomycin C, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving veliparib together with mitomycin C may kill more tumor cells.~   "
194498|NCT01017627|"~     The investigators hypothesize that the post-hospitalized patient status is characterized by~     subacute and reversible metabolic and hematological changes that, if addressed and treated in~     a timely manner, would result in a reduced risk for repeat hospitalization. Consequently, a~     structured quality improvement program, focused on increasing adherence to company wide~     anemia management policies (ie hemoglobin monitoring within the first 3-5 days~     post-hospitalization, followed by an appropriate EPO dose modification within the 7 days~     post-hospitalization), will significantly decrease the risk of hospital re-admission in the~     30 days after discharge.~   "
194501|NCT01017588|"~     This study aims to evaluate the efficacy of lumbar support for low back pain prevention in~     rubber tapper. The investigators will randomized the participants(rubber tapper) into 2~     groups;lumbar support and no support.The participant will be instructed for brace use. The~     sample size required are 200 subjects with 100 in each group. The subject will be evaluated~     every 3 month for the incidence of low back pain and quality of life after using the support.~   "
194502|NCT01017575|"~     The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined~     with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically~     infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is~     safe, well tolerated, and efficacious~   "
194503|NCT01017562|"~     In this study, the investigators utilized the 18F-fluoride PET method to evaluate THA cases~     with a stable, septic or septic loosened implant in order to differentiate these clinical~     settings using a novel uptake type classification approach.~   "
194504|NCT01017549|"~     The purpose of this multi-center clinical study is to compile post market performance and~     safety data on the Axxent System.~   "
194505|NCT01017536|"~     This was a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site~     in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either~     AERAS-402 at 3 x 10^10 vp (N=13) or placebo (N=13) on Study Days 0 and 28. Dose-escalation to~     a second group of 40 subjects was planned, but although no safety concerns were identified,~     the sponsor decided not to continue the study.~   "
194506|NCT01017523|"~     Research has shown that diabetes affects both the patient and family, and that support from~     family and partners helps diabetes patients manage their illness better. However, diabetes~     programs rarely involve the partner. The purpose of this study is to test an intervention~     that helps partners and patients who have type 2 diabetes better support each other. The~     intervention will be delivered over the telephone to reach more people. Our hypothesis is~     that an intervention that targets the couple has a greater effect on health and well-being of~     patients than one that targets the individual patient alone.~   "
194507|NCT01017510|"~     Conventional treatments include the use of steroids applied locally, or injection in to the~     legion, or oral therapy.~      Treatment is determined by the severity of the disease.~      Injection in to the legion can be done in two methods~        1. Subcutaneous injection syringe Lower~        2. Using syringe DERMOJET - a syringe without a needle. So far there are no publications in~          the medical literature of studies comparing efficacy, safety, convenience of use for~          doctor-patient, of both methods.~   "
194508|NCT01017497|"~     The purpose of this study is to estimate the rate of local control at the treated site of the~     metastasis as a function of 1mm versus 3mm expansion about the gross tumor volume (GTV). Each~     lesion, not each patient will be ranndomized to either the 1mm or 3mm margin with 40 lesions~     randomized to each arm.~   "
194509|NCT01017484|"~     Understanding the possible mechanism(s) by which the DASH dietary pattern lowers blood~     pressure will potentially enhance the value of this dietary intervention by elucidating the~     conditions under which it will be most effective, identifying target populations, examining~     its impact on vascular health beyond blood pressure, and enhancing the investigators'~     understanding of the interactions among diet, blood pressure and vascular function. In~     addition, results of this study may help to identify additional therapeutic targets.~     Therefore, the overall goal of the proposed study is to determine the mechanism(s) by which~     the DASH dietary pattern lowers blood pressure by using a controlled feeding design.~   "
194510|NCT01017471|"~     The investigators study aims to evaluate both efficacy and safety of carpal tunnel release~     using limited incision with the PSU retractor compared to standard incision.~      The investigators will do a randomized controlled trial in 60 patients with carpal tunnel~     release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score~     and complications at 6 months.~   "
194511|NCT01017458|"~     This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     MK0773 in healthy older men.~   "
194512|NCT01017445|"~     This study aims to compare the efficacy between Boonme stick exercise and quadriceps~     strengthening exercise in knee osteoarthritis.Patients diagnosed as knee osteoarthritis using~     Altman criteria will be randomized into 2 groups using simple random technique. Patients will~     be instructed and trained for both quadriceps or Boonme stick exercise by one-trained~     physical therapist. All patients will be treated with behavioral modification, NSAIDs and~     analgesic drugs and regularly follow-up . Assessment included visual analogue scale, exercise~     compliance, WOMAC and patient satisfaction were done by an assessor in a blinded fashion.~   "
194513|NCT01017432|"~     Many elderly patients have multiple medications and variable dosing regimens and the ability~     for hospitals to properly reconcile medications between what is given on paper to the patient~     and what the patients take at home depends on the patient's ability to get the medications.~     Some patients may delay in getting their medications from the pharmacy after being~     discharged. For some it may be a lack of transportation, others may feel too ill to travel~     and may not have family members who will be able to pick up the medications.~      It is for these reasons the authors of this study want to inventory the medications that an~     elderly patient is being discharged on during a home visit and check on the actual~     prescriptions that a patient has at their house the following 1-2 days after discharge.~   "
194514|NCT01017419|"~     Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are~     retained by new hearing aid users and analyze whether age, degree of hearing loss, academic~     and socio-economics status have an influence on this~   "
194515|NCT01017406|"~     The investigators study aim to evaluate the efficacy of PSU heel cushion in treatment of~     plantar fasciitis. The investigators will do a randomized controlled trial in patient with~     plantar fasciitis compared with stretching exercise alone. The outcome measurement include~     heel pain improvement, compliance, satisfaction, foot functional score at 6 months.~   "
194516|NCT01017393|"~     Chronic post-thoracotomy pain is the most common long-term complication that occurs after a~     thoracotomy with a reported incidence of up to 80%. While thoracic epidural analgesia has~     become the mainstay for managing acute post-thoracotomy pain, its effect on the chronic~     post-thoracotomy pain seems questionable. The objective of this prospective, double-blinded,~     randomized, controlled trial was to assess the effect of preemptive low-dose epidural~     ketamine in addition to preemptive thoracic epidural analgesia on the incidence of chronic~     post-thoracotomy pain.~   "
194517|NCT01017380|"~     The aims of this study was to compare analgesic efficacy of preoperative administration of~     etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior~     cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate~     ligament injury will randomized into 3 groups using opaque envelope. Both patients and~     surgeon were blinded to the allocation. All of the patients will be operated by one~     orthopaedic surgeon under regional anesthesia. Each group will be given either etoricoxib 120~     mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain~     intensity, time to first dose of analgesic requirement and numbers of analgesic used for~     rescue pain control and adverse events will be recorded periodically to 48 hours after~     surgery.~   "
194518|NCT01017367|"~     The purpose of this study is to:~        1. determine the American College of Rheumatology (ACR) 20 response rate at Day 85 in~          subjects with active rheumatoid arthritis(RA) administered MDX 1100 with methotrexate~          (MTX); and~        2. determine the tolerability and safety of multiple doses of MDX-1100 in combination with~          MTX in subjects with active RA.~   "
194519|NCT01017354|"~     This project was designed to optimizing vitamin D status in prefrail seniors age 70+ living~     at home and prevent their functional decline. We test 3 arms of monthly vitamin D~     supplementation. Intermittent dosing will improve adherence and simplify vitamin D~     supplementation.~   "
194520|NCT01017341|"~     This study aims to evaluate the efficacy of the investigators PSU hip protector for~     prevention of fracture in elderly.The eligible patients include those with previous diagnosed~     as unilateral hip fracture. They will be randomized into 2 groups;psu hip protector and no~     protector. The patients will be instructed to wear the protector fulltime.The inceidence of~     hip fracture will be compared between both group at the end of 1 year.~   "
194521|NCT01017328|"~     Effect of head rotation on overlap and relative position of internal jugular vein to carotid~     artery in infants and children: A study of the anatomy using ultrasonography.~   "
194522|NCT01017315|"~     This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast~     application in orthopaedic patients.~      The investigators will do a randomized controlled trial in patient with fracture distal end~     of radius treated conservatively.~      Pruritus score and satisfaction will be monitor along the entire course of cast retention.~   "
194523|NCT01017302|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type~     2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the~     study. There will be a 5-weeks exenatide run in period and a 5-weeks period when~     co-administered with the study drug. RO5095932 will be administered subcutaneously as a~     single dose or as escalating doses. Patients will be randomized to receive either active drug~     or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4~     weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5.~     Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of~     active drug in week 5. The anticipated time of study treatment is <6 months. The target~     sample size is <100 patients.~   "
194524|NCT01017289|"~     The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the~     Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.~   "
194525|NCT01017276|"~     This is a multi-center, open-labeled, non-comparative study to examine the safety and~     efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal~     dialysis.~   "
194526|NCT01017263|"~     The purpose of this study to assess the effects of chronic administration of Vyvanse~     (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with~     Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are~     obese.~   "
194527|NCT01017250|"~     The purpose of this study is to assess the central nervous system (CNS) toxicity in patients~     with recurrent malignant gliomas treated with concurrent Avastin and stereotactic~     radiosurgery (SRS).~   "
194528|NCT01017237|"~     Intravenous sedation is used frequently for the relief of pain and anxiety associated with~     oral surgical procedures performed under local anesthesia. The purpose of this study is to~     learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in~     combination with midazolam alone or with midazolam plus low dose ketamine while having wisdom~     teeth removed.~      The sedation produced by dexmedetomidine is unique in that it mimics natural sleep, a unique~     quality not shared by other drugs. Dexmedetomidine is often used in anesthesia in hospital~     operating rooms and has been approved by the US Food and Drug Administration for the use~     planned in this study.~   "
194529|NCT01017224|"~     Solid tumours contain varying degrees of hypoxia. Studies show hypoxia to be associated with~     poor local control and survival, as hypoxia is a cause of resistance to radio- and~     chemotherapy and the development of a more aggressive tumour.~      Previous attempts to measure hypoxia have been biased because the techniques have been~     invasive, not repeatable or difficult to apply on a routine basis. There is great interest in~     trying to measure hypoxia in tumours as this could lead to individualized hypoxia-modifying~     therapy and prediction of treatment response. Additionally the investigators' knowledge of~     change in hypoxia over time is limited, but of great interest as individualised treatment,~     such as intensity-modulated radiation therapy (IMRT) is emerging.~      18F-FAZA, appears promising. It is a nitroimidazole, which gets trapped in hypoxic cells and~     can be detected by a positron emission therapy (PET) scan. Compared to other nitroimidazoles,~     18F-FAZA has superior biokinetics and thereby is believed to provide a faster and clearer~     image of hypoxia.~      The investigators' hypothesis is that 18F-FAZA can be used as a prognostic marker in HNSCC.~   "
194530|NCT01017211|"~     Needle Electromyography (EMG) is an important test used to assess muscle and nerve function,~     but the test can be uncomfortable. It is currently not standard practice to provide any~     pain-relieving intervention for this procedure. The purpose of this research study is to~     determine whether auricular (ear) acupuncture will make EMG testing less painful.~   "
194531|NCT01017198|"~     This study is designed to assess the effect of food and antacid use on the pharmacokinetic~     properties of BIIB021.~   "
194532|NCT01017185|"~     The purpose of this study is to determine whether HF10 is safe and effective in the treatment~     of head and neck cancer or solid tumors with cutaneous and/or superficial lesions.~   "
194538|NCT01017107|"~     Activated protein C (APC)has been shown to reduce mortality in severe sepsis(Bernard et al.~     2001b). The clinical picture of severe acute pancreatitis (AP) is similar to that of sepsis.~     The investigators conducted a randomised double-blinded placebo-controlled pilot study in AP~     patients (16+16) with the same dose of APC that has been proven to be efficacious and safe in~     septic patients.~      The aim of the study is to investigate whether the APC replacement therapy diminishes the~     occurrence and severity of organ dysfunction in patients with severe AP. The effect of APC on~     inflammatory and hemostatic parameters is also assessed.~   "
194539|NCT01017094|"~     This study aimed to compare the efficacy of pin-tract infection prevention between~     silversulfadiazine and dry dressing.~      Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from~     September 2007 to June 2008 and treated by emergency debridement and external fixation were~     randomized into two groups, one treated with silversulfadiazine for infection prophylaxis~     (15) and a control group treated with dry dressing only (15). All patients were followed~     until the external fixator was removed. Pin-site infections were assessed and graded at each~     follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin~     site was done if an infection occurred.~   "
194540|NCT01017081|"~     Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia~     however there was no evidence to support a beneficial effect in pediatric patients.~   "
194541|NCT01017068|"~     The purpose of this study is to determine the effect of Aqueous mushroom extract (AME) on~     intra ocular pressure (IOP) in humans or as a potential anti glaucoma drug.~   "
194542|NCT01017055|"~     Evaluate voice and swallowing outcomes post operatively.~   "
194543|NCT01017042|"~     This study aims to characterize the pharmacokinetic profile of colchicine after a regimen of~     1.8 mg over two hours. A secondary goal is to evaluate the safety and tolerability of this~     regimen in healthy volunteers. To this end, all study subjects will be monitored for adverse~     effects throughout the entire study period.~   "
194544|NCT01017029|"~     The purpose of this study, in de novo heart transplant patients, is to evaluate whether~     delayed introduction of everolimus reduces the occurrence of wound healing problems,~     pericardial and/or pleural effusion and early acute renal insufficiency, as compared with~     immediate introduction of everolimus, in the firs six months after heart transplantation.~   "
194545|NCT01017003|"~     This open label, single group, sequential dose study will compare the single dose~     pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10~     days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.~   "
194546|NCT01016990|"~     RATIONALE: Valproic acid may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. It may also help cancer cells become more like normal cells, and grow~     and spread more slowly.~      PURPOSE: This phase II trial is studying how well valproic acid works in treating patients~     with previously treated non-Hodgkin Lymphoma, Hodgkin lymphoma, or chronic lymphocytic~     leukemia.~   "
194547|NCT01016977|"~     A single-blind (investigator-blinded), randomized, parallel group, single center study to~     evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac~     Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.~   "
194548|NCT01016964|"~     The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam~     model for androgenetic alopecia in females when treatment is applied as directed.~   "
194549|NCT01016951|"~     The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of inhaled AZD9164 following administration of multiple ascending doses in~     healthy male and female subjects and COPD patients.~   "
194550|NCT01016938|"~     Radiation treatment for each patient with cancer is designed based on CT scans. We know that~     tumors in the chest and abdomen move when you breathe. Because of this, there can be~     differences between planned treatment and the treatment actually delivered to the body.~     Usually with radiation a safety margin is added to ensure that radiation hits the entire~     tumor. This can damage healthy parts of the body because the exact location of the tumor is~     unknown.~      Magnetic resonance imaging (MRI) is a painless and safe diagnostic procedure that uses a~     powerful magnet and radio waves to produce detailed images of the body's organs and~     structures, without the use of X-rays or other radiation.~      The research doctors are studying to see if the position of a tumor can be tracked using MRI~     scans and tracking sensors placed on the skin. MRI scans and the tracking system used to~     calculate the location and position of the tumor are both FDA approved technologies.~      The research doctors will also use the MRI scans to evaluate any changes in your lung~     function during and following your radiation treatments.~      In this study the participant will undergo a series of MRI scans with and without contrast~     dye.~      This study is being funded through grants from the National Institutes of Health (NIH).~   "
194551|NCT01016925|"~     Background: Bacterial colonization of peripheral nerve catheters is frequent, although~     infection is relatively rare. With central venous catheters, the tunneling of catheter into~     the subcutaneous tissue significantly decreases catheter colonization and catheter-related~     sepsis.~      Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in~     adult patients with femoral tunnelized perineural nerve catheters.~      Methods: A total of 338 patients with femoral catheter will be included in the study. The~     patients will be randomized to be included in the control group (without tunnelling) or in~     the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be~     analyzed for colonization (primary outcome). Quantitative culture will be used as described~     by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily~     for any signs of infection (secondary outcome).~      Perspective: To show the incidence of femoral perineural catheter colonization is low with~     subcutaneous tunneling~   "
194552|NCT01016912|"~     The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well~     tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the~     treatment of hepatitis C virus genotype 1 in chronically infected patients who are~     treatment-naïve and nonresponsive to the standard of care~   "
194689|NCT01015092|"~     The purpose of the study is to determine the main factors contributing to predicted 10 year~     cardiovascular risk in an HIV infected cohort, and the role of anti-HIV drug use in altering~     this risk~   "
194553|NCT01016899|"~     The objective of this study is to record recurrence in patients treated for nonmelanoma~     (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic~     Brachytherapy System. Additional objectives include evaluate the appearance of the treated~     area in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic~     Brachytherapy System and record the occurrence of radiation therapy related skin changes in~     patients treated for nonmelanoma skin cancer.~   "
194554|NCT01016886|"~     While trastuzumab has been shown to prevent recurrences of breast cancer, some women may also~     experience damage to their heart muscle (including heart failure) as a result of their~     treatment. The investigators hope to learn if standard medications used in heart failure can~     prevent heart damage caused by trastuzumab in women with breast cancer. The investigators~     would also like to know if there are any ways to detect this damage earlier using magnetic~     resonance imaging (MRI) and blood tests.~   "
194555|NCT01016873|"~     The purpose of this study is to confirm the safety and establish the effectiveness of two~     doses from the IRay System for the treatment of wet AMD.~   "
194556|NCT01016860|"~     This study plans to learn more about an investigational drug called OSI-906. OSI-906 is being~     looked at to see if it could be a treatment for advanced cancer. The FDA is the U.S.~     government agency that reviews the results of research of drugs and decides if it can be sold~     in the U.S. OSI-906 has been given to over 185 people with cancer.~   "
194557|NCT01016847|"~     Obesity is associated with increased airway inflammation and asthma severity that results in~     suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS).~     The investigators suggested that the addition of Singular (montelukast)[LTRA] to moderate~     doses of inhaled corticosteroids will improve asthma control. This cross over study will be~     treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12~     weeks.~   "
194558|NCT01016834|"~     The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel~     DosePro to treat their moderate to severe migraines.~   "
194559|NCT01016821|"~     Childbirth is one of the most painful events that a woman is likely to experience, and thus~     is a major concern for most parturient. Severe pain releases stress mediators and may thus~     compromise fetus well-being if placental perfusion is decreased. Epidural analgesia is the~     golden standard for the management of severe labor pain. However, it could not always be used~     both due the parturient related factors and the organizational reasons.However, the knowledge~     on safety and efficacy of oxycodone involving mother, fetus and newborn is limited.~      Aim of the study is firstly, to evaluate the efficacy and safety of oxycodone in labor pain~     healthy parturients. Secondly, to measure parturient's blood oxycodone concentration during~     labour and fetal concentration from placental umbilical vein and artery right after birth.~   "
194560|NCT01016808|"~     This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8~     mg versus its individual morphine sulfate and oxycodone hydrochloride components for the~     management of acute moderate to severe postoperative pain following bunionectomy surgery.~   "
194561|NCT01016795|"~     Clinical Hypothesis:~      It is expected that by removing chemotherapy and adding ancestim to the mobilization scheme~     in most of the subjects sufficient PBPC will be harvested with a minimum of toxicity and side~     effects.~   "
194562|NCT01016782|"~     The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the~     Treatment of Inflammatory Lesions of Rosacea.~      Treatment medication will be administered as follows: A thin film of gel will be applied and~     rubbed into the entire face once daily for a period of 70 days.~   "
194563|NCT01016769|"~     The purpose of this study is to find out the good and bad effects that occur when~     temsirolimus is added to standard chemotherapy with carboplatin and paclitaxel.~   "
194564|NCT01016756|"~     1. PHACE syndrome(OMIM database number 606519) is the association of a vascular birthmark~          (hemangioma) on the face along with one or more of the following conditions: congenital~          heart defects, congenital anomalies of the cerebral arteries,brain, eyes, or sternum.~        2. A research study is currently being conducted at the Medical College of Wisconsin (MCW)~          to investigate if there is an inherited cause of PHACE syndrome.~        3. We are hoping that this study will lead to a better understanding of how and why~          children develop PHACE syndrome.~   "
194565|NCT01016743|"~     To test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective~     and cognitive deficits in patients with asymmetric Parkinson's disease (PD) and to establish~     its safety in this population. The investigators anticipate that reaching deeper brain layers~     and larger volume of activation with the novel H-coil may induce significantly better~     therapeutic effects in patients with PD and will pave the way for establishing a novel and~     effective treatment for this disorder.~   "
194566|NCT01016730|"~     This pilot, phase I trial studies the side effects and best dose of bortezomib in treating~     patients with acquired immune deficiency syndrome (AIDS)-related Kaposi sarcoma that has come~     back or has not responded to treatment. Bortezomib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
194567|NCT01016717|"~     To find out the impact of two different proton-pump inhibitors (PPIs) (Omeprazole and~     Pantoprazole) on platelet function in patients with stable coronary artery disease (CAD) on~     clopidogrel therapy.~   "
194568|NCT01016704|"~     The specific aims of the proposed study are to evaluate the effectiveness and~     cost-effectiveness of providing monetary incentives to therapists as a method to improve~     implementation of evidence-based treatments.~   "
194569|NCT01016691|"~     Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma~     or ocular hypertension.~   "
194570|NCT01016678|"~     The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4~     sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month~     period. They will be required to have three office visits during the six months. All subjects~     will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo~     (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm~     will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will~     prove to be a safe and effective treatment for this population, that has so few treatment for~     migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24~     hours.~   "
194571|NCT01016665|"~     Background: Identification of new biomarkers with potential predictive and prognostic role~     has contributed unequivocally to breast cancer treatment.~      Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER~     and progesterone- PR), some patients become hormone resistant. In order to identify a~     possible profile associated to hormonal resistance, some biomarkers have been assessed after~     short period primary hormone therapy (HT).~      Objectives: To compare the expression of Ki-67, Bcl2, Bax, Bak, ER and e PR in postmenopausal~     women with ER positive invasive ductal carcinomas (IDC), prior and after tamoxifen and~     anastrozole in short term hormone therapy.~   "
194572|NCT01016652|"~     The purpose of this study is to evaluate the effect of a multi-focal contact lens on~     symptomatic patients.~   "
194573|NCT01016639|"~     The purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and~     capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors.~     The trial consists ot two separate studies; CORGI-U in patients with stomach- bile ducts-~     gallbladder and pancreas cancer, and CORGI-L in patients with colorectal cancer.~      CORGI-U will be designed as a phase-I-II-study,in which the first part will be a chemotherapy~     dose finding study, followed by a phase II part to establish response rates. All subjects~     receives radiotherapy concommitant.~      CORGI-L is a phase II trial, in which patients are treated with chemotherapy at fixed doses~     with radiotherapy concommitant.~   "
194574|NCT01016626|"~     The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic~     characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when~     administered alone to healthy volunteers.~   "
194575|NCT01016613|"~     Chronic kidney disease (CKD) affects approximately 26 million Americans and~     disproportionately manifests in specific race and ethnic groups. Patients burdened with CKD~     have significant morbidity and reduced life expectancy. In addition to excessive suffering~     and lost productivity, the cost of managing this epidemic has reached $40 billion annually.~     The recognition that CKD is a major public health problem is reflected in the fourteen~     objectives outlined in Healthy People 2020 to begin to address the disease burden.~     Advancement in approaches to halt CKD progression has been slow despite growing global~     awareness of disease burden.~      This O'Brien Kidney Research Core will create opportunities for novel insights through~     characterization of tissue profiles that will define new disease markers and molecular~     pathways and will be available to all kidney investigators on the www. It will thereby~     fundamentally alter the starting point for research into prevention of progression of these~     kidney diseases. C-PROBE is an essential element of the center grant and presents a~     biomedical resource core consisting of: (1) clinical phenotyping (that is, systematic~     identification of observable physical and biomedical characteristics) of kidney disease~     patients including the accurate measurement of kidney function; and (2) a specimen BioBank~     which will store blood, urine and kidney tissue samples. A key component of C-PROBE is~     therefore that it contains a proven mechanism to collect samples from high risk groups~     including minorities, at the institutions of University of Michigan Health System, St. John~     Hospital, Wayne State University in Michigan, John H. Stroger Hospital in Illinois, Temple~     University Health System in Pennsylvania, and Levine Children's Hospital in North Carolina.~     This mechanism will feed the other Cores and provide biomedical investigators with approved~     projects the access to a dynamic pool of well characterized high risk kidney disease patients~     and their biological specimens to conduct high caliber translational research.~   "
194576|NCT01016600|"~     Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for~     patients with Acute Myeloid Leukemia~   "
194577|NCT01016587|"~     COPD patients often have a wide range of physical (e.g., dyspnea, fatigue, pain) and~     psychological (e.g., depression, anxiety) symptoms and various other debilitating conditions~     that cause considerable suffering for the individual. Unfortunately, many of the symptoms and~     health problems in patients with COPD are unrecognized and untreated. Due to the irreversible~     nature of COPD, the aim is not to cure the disease, but to reduce symptoms and improve~     quality of life.~      Therefore, the purpose of this project is to investigate the existence and nature of symptom~     clusters over time in patients with COPD and their effects on patient outcomes. Since this~     study aims to identify possible new subgroups of patients with COPD defined by the clustering~     of certain symptoms, the study also aims to investigate the relationship between the clinical~     presentation and certain immunologic and genetic factors.~   "
194578|NCT01016574|"~     The purpose of this study is to evaluate the Giro-couch, an innovative patient support device~     for the application of prone RT for treatment of breast cancer. This study will assess the~     feasibility of a new positioning approach to facilitate the delivery of external beam,~     delivered to the lumpectomy cavity, (the boost dose, partial breast therapy).~   "
194579|NCT01016561|"~     Rationale: Computer systems that allow doctors to create a 3 dimensional (3-D) picture of the~     tumor may help in planning radiation therapy and may result in more tumor cells being killed.~     Specialized radiation therapy that delivers a high dose of radiation directly to the tumor~     may kill more tumor cells and cause less damage to normal tissue. Drugs, such as cisplatin,~     may make tumor cells more sensitive to radiation therapy.~   "
194580|NCT01016548|"~     The purpose of this study is to determine whether adults with hematologic malignancies on~     active systemic therapy or shortly after bone marrow transplantation need one or two doses of~     adjuvanted vaccine to achieve best possible rates of protection. An additional research~     question is whether baseline biomarkers of the cellular and humoral immune systems are~     associated with an antibody response to vaccination.~   "
194581|NCT01016535|"~     This study aimed to identify the perceptions of family caregivers and professionals of the~     Family Health Strategy (FHS) for health care for children from 0 to 2 years, and actions on~     this issue developed by the FHS.~   "
194582|NCT01016522|"~     This research is being done to see if the ketogenic diet (which is high in fat and low in~     carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are~     fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective~     in the treatment of ALS.~   "
194583|NCT01016509|"~     A multicentric study will evaluate whether peri-procedural tight glycemic control during~     angioplasty revascularization for acute coronary syndrome (ACS) reduces circulating~     inflammatory cytokines and thrombus formation in hyperglycaemic patients. Moreover, the~     investigators will assess whether the tight glycemic control during the first month from~     coronary event reduces the incidence of coronary stent restenosis at 6-months from PCI.~   "
194609|NCT01016145|"~     The objective of this study is to evaluate predictors of response to antipsychotic medication~     in subjects with schizophrenia. The investigators will evaluate psychopathology,brain MRI,~     genetics and neuropsychological profile. Two groups of treatment will be compared: first~     generation antipsychotics vs. second generation antipsychotics. Participants will be~     randomized to one of the groups. Trial duration: 12 weeks.~   "
194584|NCT01016496|"~     Evidence exists that the activation of actions activates the same cortical motor areas that~     are involved in the performance of the observed actions. The neural substrate for this~     phenomena is the mirror neuron system. It is generally assumed that mirror neurons have a~     basic role in understanding the intentions of others and in imitation learning. There is~     evidence that action observation has a positive effect on rehabilitation of motor disorders~     after stroke. The aim of this study is to demonstrate that action observation followed by the~     repetition of the actions previously observed has a positive impact on rehabilitation of the~     upper limb in children affected by hemiplegia as a consequence of Cerebral Palsy. In~     particular, the purpose is to assess if mirror neurons could improve the amount, the quality~     and the velocity of movements and the cooperation between the two upper extremities.~   "
194585|NCT01016483|"~     The research trial is testing the experimental treatment MSC1936369B in combination with~     Gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. The study will be run in~     two parts:~      Safety Run-In: Will determine the Maximum Tolerated Dose (MTD) and the recommended Phase II~     dose of MSC1936369B, when combined with gemcitabine, in subjects with metastatic pancreatic~     adenocarcinoma.~      Phase II: Will assess the anti-tumor activity of MSC1936369B combined with gemcitabine~     compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic~     adenocarcinoma.~   "
194586|NCT01016470|"~     The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could~     improve the progression disease, in patients with Parkinson's Disease (PD).~   "
194587|NCT01016457|"~     The purpose of this study is to compare glucose control, quality of life and number of~     hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal~     hypoglycemia can be missed even when the parents check their children's blood glucose several~     times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by~     using the sensor in this age group. As a consequence, quality of life of the families will~     improve. The investigators also hypothesise that diabetes control will improve at 3-6 months~     from the beginning of the study.~   "
194588|NCT01016444|"~     The hypothesis to be tested is that acutely ill asthmatics who do not resolve their attacks~     following standard doses of albuterol and require admission to hospital have single~     nucleotide polymorphisms of their B2 adrenergic receptors that lower B2 agonist responsivity.~   "
194589|NCT01016431|"~     Chronotropic incompetence consists of an insufficient increase in heart rate during effort,~     and its presence is recognized as a common feature in patients with heart failure due to left~     ventricular systolic dysfunction, apparently suggesting a worse prognosis. Little is known~     about the possible benefits of its reversal in such patients.~      The investigators working hypothesis is that the modulation of chronotropic response, as~     obtained by means of atrial rate-adaptive pacing may improve functional capacity in persons~     with chronic heart failure and chronotropic incompetence.~      To explore this hypothesis,the investigators will enroll 20 patients with NYHA II/III heart~     failure, low left ventricular ejection fraction (<40%) and chronotropic incompetence (Maximal~     heart rate <80% of predicted value in a symptom-limited incremental test), who already~     underwent implantation of dual-chamber implantable defibrillator for prevention of sudden~     cardiac death. The study will have a randomized, double-blind, cross-over design.~      The procedures, to be carried out at one month from each reprogramming (VVI backup pacing vs.~     AAI-R active pacing), will comprise: blood sampling for NT-proBNP, incremental~     symptom-limited cardiopulmonary exercise testing (CPX), constant-workload cardiopulmonary~     test (50% of max WR), quality-of-life questionnaire, 24-hour ECG monitoring.~      The primary end-point will be peak oxygen consumption on CPX. Secondary end-points will~     include acute response to reprogramming, and data derived from constant-WR tests, Holter~     monitoring and QoL.~   "
194590|NCT01016418|"~     Trial Synopsis: Bovine Colostrum for patients with non alcoholic fatty liver disease (NAFLD).~      Design: This is a single-arm, open-label, before-and after exploratory trial of 30 days of~     Bovine Colostrum Powder (BCP) to improve NAFLD and the metabolic syndrome.~      Duration: 8 weeks per subject.~      Sample Size: 30 subjects.~      Population: Patients with biopsy proven NASH (NAS of > 4) and an ALT level of ≥ 30 (U/L).~      Regimen Study treatment will consist of BCP, three 1.2 g oral tablets (equivalent to 600 mg~     of BCP each) for 4 weeks, from cows immunized to insulin. Patients will be followed for~     safety monitoring for an additional 4 weeks.~   "
194591|NCT01016405|"~     This study will determine the incidence and severity of dry eye in patients undergoing~     cataract surgery as determined by grade on the International Task Force (ITF) scale.~   "
194592|NCT01016392|"~     Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is~     required by the body to use an amino acid called phenylalanine in order to build another~     substance called tyrosine.~      Kuvan® received marketed authorisation in Europe in December 2008 and is now available in~     several European countries for the treatment of Hyperphenylalaninemia (HPA).~      The primary objective is to assess the long-term safety in subjects treated with Kuvan®.~      Secondary objectives are to provide additional information regarding:~        -  Safety in specific subject groups (elderly, pediatric, pregnant women and subjects with~          renal or hepatic insufficiency).~        -  Growth and neurocognitive outcomes for subjects with hyperphenylalaninemia (HPA) who are~          receiving treatment with Kuvan®.~        -  Progress and outcome of pregnancy for women with HPA who become pregnant while receiving~          treatment with Kuvan® (these women will be enrolled in a dedicated sub-registry).~        -  Assessment of adherence to diet and to Kuvan®.~        -  Assessment of long-term sensitivity to Kuvan®treatment.~   "
194593|NCT01016379|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how well patients will respond~     to treatment.~      PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young~     patients with acute lymphoblastic leukemia.~   "
194594|NCT01016366|"~     The primary purpose of the study is to determine whether carbamylated erythropoietin is a~     safe treatment for patients who suffer from Friedreich's Ataxia.~   "
194610|NCT01016132|"~     The purpose of this study is to assess the performance of an investigational contact lens~     among contact lens wearers.~   "
194611|NCT01016119|"~     The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of~     the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.~   "
194595|NCT01016353|"~     This study is being done to gather data that will be used to compare two different TAC~     (Temporary Abdominal Closure) methods that your doctor may use. The two TAC methods being~     compared are the Barker's vacuum packing technique or BVPT and the Open Abdomen Negative~     Pressure Therapy System (ABThera) developed by the sponsor of this research (KCI, San~     Antonio, TX). The BVPT is made up of supplies that are stocked in most surgery rooms. The~     ABThera dressing is available commercially. Neither method will be supplied to the doctor~     (Principal Investigator), so that in no way would the subject's standard of care be different~     from what they would get if the study was not being done.~      This study is observational and only collects data about how the subject progresses after~     surgery TAC is used. When a study is observational it means that the subject's standard~     medical care will not be altered in any way, simply watched. The doctor will not change~     treatment of your open abdomen.~   "
194596|NCT01016340|"~     This is a phase II randomized, double-blind, placebo-controlled study where eligible~     subfertile male subjects (age 20 years).~   "
194597|NCT01016327|"~     The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase~     inhibitor, in adult patients with advanced solid tumors.~   "
194598|NCT01016314|"~     This is a multi-center, prospective randomized clinical study to evaluate the clinical~     outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental~     posterior fixation using ASPEN Spinous Process System compared to pedicle screw~     instrumentation.~   "
194599|NCT01016301|"~     The aim of the present study is to evaluate effects of a clinical pharmacist service on~     health-related quality of life and prescribing of drugs.~   "
194600|NCT01016288|"~     The aim of the study is to compare the performance characteristics of EUS-FNA 22 Gauge needle~     and EUS FNA 25 Gauge needle in terms of cellularity and diagnostic yield for diagnosis of~     various pathologies, including lymph nodes, pancreatic, luminal and other lesions outlined by~     EUS.~   "
194601|NCT01016275|"~     The objective of this clinical study is to evaluate, in a controlled setting, the long-term~     (up to 24 months) outcome of the self-expanding nitinol rapid-exchange Misago (Terumo) stent~     in TASC A and B iliac lesions.~   "
194602|NCT01016262|"~     Hypothesis: The responder rate of the MAX-002 will be superior to placebo after 6 weeks of~     treatment in patients with mild to moderate ulcerative proctitis.~      Summary: The primary purpose of this study is to evaluate the efficacy and safety of new~     mesalamine suppositories (MAX-002) as compared to placebo after 6 weeks of treatment in~     adults with mild to moderate ulcerative proctitis.~      Prior to randomization, all inclusion and exclusion criteria will be verified to confirm~     eligibility. Patients found to be eligible will be randomized in a 1:1:1 scheme to receive~     either MAX-002 1 g, Canasa® 1 g, or Placebo suppository once daily at bedtime for 6 weeks in~     a double-blind fashion. Completers at Study Week 6 will be offered to receive MAX-002 1 g~     suppositories on a voluntary basis during the next 8 weeks of the open-label phase.~     Regardless of the treatment groups, all patients will be evaluated through phone calls at~     Study Weeks 1 and 2 followed by clinical visits at Study Weeks 3, 6, and 14. Study-specific~     procedures include but are not limited to the following: flexible proctosigmoidoscopy;~     disease activity assessment; smoking habits description; health-related quality of life;~     compliance to treatment check and safety evaluations (physical examinations, ECG, vitals~     signs, clinical laboratory analyses). All patients will complete daily diaries and will be~     asked general open questions about any occurrence of adverse events/concurrent medical~     conditions, use of adjunctive therapy/procedure, and their intake of concomitant medication.~   "
194603|NCT01016249|"~     The investigators reasoned that a hypertonic saline concentration higher than 3% could be~     safe and more efficacious in the treatment of bronchiolitis, alleviating severe symptoms and~     preventing the need for hospitalization in some instances.~   "
194604|NCT01016223|"~     The investigators hypothesize that swallowed beclomethasone leads not only to improvement of~     symptoms and decreased number of eosinophils in esophageal mucosa, but also to a decrease in~     other markers of tissue inflammation like mast cells, CD4+ T lymphocytes, IL4, IL-5, IL13,~     GM-CSF and TGF-beta as well as serum ultra-sensitive C-Reactive Protein (CRP). The~     investigators aim to characterize the response of esophageal inflammation to swallowed~     topical glucocorticoids, and identify biomarkers to assess response to treatment.~      This research will elucidate the effect of treatment with beclomethasone on various~     inflammatory markers in EoE, which is currently not well-understood. This work will explore~     the pathophysiology of EoE, and has the potential to find a non-invasive biomarker such as~     high-sensitivity CRP that can be used to monitor the response to treatment.~   "
194605|NCT01016210|"~     To explore whether recombinant LH (rLH) supplementation (Leuveris) to recombinant follicle~     stimulating hormone (rFSH) following GnRH antagonist treatment has an advantage in infertile~     women with advanced reproductive ageing undergoing IVF-ET.~   "
194606|NCT01016197|"~     The investigators are investigating if surgical treatment of injuries to the tendon which~     straightens the finger tip gives a better functional outcome than treatment with a splint~     while the tendon heals.~   "
194607|NCT01016184|"~     Vitamin D has multiple systemic effects: bone and calcium metabolism, muscle function,~     insulin responsiveness, body-composition regulation, cell differentiation, and the immune~     system. Proper status of vitamin D is found to be related to risk reduction in hypertension,~     cardiac and vascular diseases, autoimmune diseases, and others. Furthermore, vitamin D~     supplementation resulted in improved endothelial function. Limited sun exposure may lead to~     vitamin D deficiency, and it may be assumed that modern life styles lead to a lack of sun~     exposure. Long work-days may be the primary risk factor for vitamin D deficiency. The purpose~     of this research is to study the effect of vitamin D treatment on multi systemic functions in~     young healthy men with vitamin D deficiency due to working conditions.~   "
194608|NCT01016158|"~     In the present study, the investigators investigated the efficacy of umbilical cord serum eye~     drops for the treatment of patients with recurrent corneal erosions. Group A were treated~     with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears,~     and group B were treated with artificial tears only. Ophthalmic examinations including visual~     acuity measurement and slit lamp biomicroscopy were performed before and every month after~     treatment. Recurrence was defined as the presence of clinical symptoms accompanied by~     epithelial defects in the cornea.~   "
194612|NCT01016106|"~     The investigators' primary objective is to identify common and rare mutations in the~     filaggrin gene in African American patients with a diagnosis of atopic dermatitis and~     ichthyosis vulgaris. Atopic dermatitis, or eczema, is a common, chronic, relapsing and~     remitting problem in many children and affects 10-20% of the pediatric population. Itch is a~     predominant feature of this disease and is quite disruptive to daily activities of life. In~     addition to itch, it is characterized by markedly dry skin, small red bumps that may have~     fluid. Ichthyosis vulgaris is characterized by extremely dry, scaly skin with a fine white~     scale and increased amounts of lines noted on the palms. Filaggrin is a protein that is~     essential for the skin to function properly as a barrier and found to be mutated in some~     European patients with ichthyosis vulgaris and atopic dermatitis. This association has not~     been looked at in the African American population. Genomic DNA (gDNA) will be purified from~     buccal swabs using commercially available kits and analyzed.~   "
194613|NCT01016093|"~     This is prospective randomized, double blind study designed to evaluate the use of zoledronic~     acid in the prevention prevention of bone loss post allogenic BMT done for beta-thalassemia~     major patients.~   "
194614|NCT01016080|"~     Oral and intravenous glutathione have been used widely to whiten the skin. The investigators~     tested this hypothesis by giving oral glutathione for 4 weeks to medical students.~   "
194615|NCT01016067|"~     Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to~     autograft in the treatment of tibial delayed healing.~   "
194616|NCT01016054|"~     This is a parallel arm study to evaluate AGS-8M4 administered in combination with~     chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion~     until disease worsens.~   "
194617|NCT01016041|"~     Instead of treating in-stent restenosis, the best strategy for patients is preventing~     in-stent restenosis. Recent advances in the understanding of the cellular mechanism~     responsible for smooth muscle cell proliferation (neointimal hyperplasia), together with~     improvement in stent coating and eluting technology have provided the scientific background~     to develop drug eluting stents. Drug eluting stents (DES) are now the most promising~     development in interventional cardiology. Different classes of drugs mounted in a polymer~     layer on the surface of the stent have shown to be very effective in preventing neointimal~     hyperplasia. Currently there are 7 DES stents CE marked and commercially available on the~     market. Two stents, respectively the sirolimus eluting Cypher™ stent and the paclitaxel~     eluting Taxus™ stent, are in clinical use since 2002. The Cypher™ stent consists of the Bx~     sonic stent/balloon platform. The stent is coated with a non-degradable biocompatible~     PBMA/PEVA polymer which elutes sirolimius. The Taxus™ stent consists of the Express2~     balloon/stent platform coated with non-degradable biocompatible Translute™ polymer which~     elutes paclitaxel.~      Recent large randomized trials like RAVEL, SIRIUS, E-SIRIUS C-SIRIUS (Cypher™ versus bare~     metal BX sonic™ stent), TAXUS II, IV, V, VI (Taxus versus bare metal Express™ stent) have~     shown that DES dramatically reduce the incidence of in-stent restenosis and subsequently the~     need for target lesion revascularization in patients with non complex and moderate long~     de-novo coronary lesions in vessels with a diameter between 2.5 -3.5 mm.1-11 Considering the~     very encouraging results of these early clinical trials with so far mid long term follow-up,~     there is the need to explore the utilization of DES in the other subsets of coronary lesions~     like: long lesions, chronic total occlusions, venous graft lesions, thrombotic lesions,~     restenosis lesions, ostial and bifurcation lesions and lesions in large vessels.~      As the result from the previous reported randomized trials, FDA and other regulatory~     institutes require that new DES are now being evaluated against one of the former DES (Cypher~     or Taxus). The XIENCE-V stent is a second generation DES, with thinner and more flexible~     Cobalt-Chromium stent struts, compared to the first generation Stainless Steel stent struts~     of Cypher and Taxus. This study addresses the questions whether the XIENCE-V™ stent has~     superior clinical results as the Taxus™ stent in the general population that is being~     referred for percutaneous coronary intervention (PCI).~      Objective of the study:~      The main objective of the study is a head tot head comparison of the everolimus coated~     XIENCE-V™ stent with the paclitaxel coated TAXUS™ stent in order to observe whether there is~     a difference in clinical outcome between both stents.~      Efficacy of both stents will be assessed by the composite end point of: all death, non fatal~     myocardial infarction and target vessel revascularization.~      Study design:~      Single center, randomised, open label study in all-comers referred for PCI.~      Study population:~      Approximately 1600 consecutive patients with coronary artery disease who are eligible~     according to the in- and exclusion criteria will be enrolled and randomized on a 1:1 basis.~      Primary study parameters/outcome of the study:~      The primary end point of the study is the composite end point of: all death, non fatal~     myocardial infarction, target vessel revascularization at 1 year.~      Secondary study parameters/outcome of the study:~      The secondary end points of the study are:~      A) The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven~     target lesion revascularization (TLR) rate at 1, 6 and 12 months follow-up.~      B) The combined endpoint of all death, non fatal myocardial infarction, target vessel~     revascularization (TVR) rate at 2, 3, 4 and 5 years.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      The burden for the patient consists of filling in 8 questionnaires (1 A4 per questionnaire)~     in 5 years time.~      The first 3 questionnaires in the first year are also requested for monitoring purposes by~     the Ministry of Health and the Dutch Cardiology Society (Nederlandse Vereniging Voor~     Cardiologie; NVVC).~      There is no risk for the patient related to participation in this study. The patient will~     receive a Taxus or Xience-V stent anyhow, if the indication for a DES stent exists.~   "
194618|NCT01016028|"~     The goal of this research study is to learn more about pain and other symptoms that patients~     may experience while receiving chemotherapy treatment with platinum agents, taxanes, and/or~     bortezomib.~   "
194619|NCT01016015|"~     This phase II trial studies how well temsirolimus and cixutumumab works in treating patients~     with locally advanced, metastatic, or recurrent soft tissue sarcoma or bone sarcoma.~     Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth by blocking~     the ability of tumor cells to grow and spread. Giving temsirolimus with cixutumumab may be an~     effective treatment for soft tissue or bone sarcoma.~   "
194620|NCT01016002|"~     The purpose of this study is to assess efficacy and safety of Foscan (temoporfin)~     photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma~     without distant metastases.~   "
194621|NCT01015989|"~     The purpose of this study is to see if a computerized counseling tool helps patients reduce~     their sexual transmission risk and improve their antiretroviral adherence.~   "
194622|NCT01015976|"~     The purpose of this study is to determine the difference, if any, in the area under the~     sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post~     Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and~     gender.~   "
194623|NCT01015963|"~     This research trial studies deoxyribonucleic acid (DNA) in blood samples from Caucasian and~     African-American cancer patients who received docetaxel on clinical trial CLB-9871. Studying~     samples of blood from patients with cancer in the laboratory may help doctors learn more~     about changes that occur in DNA and identify biomarkers related to cancer. It may also help~     doctors learn more about how docetaxel is used by the body.~   "
194624|NCT01015950|"~     The objectives of the study are to assess the impact of different dietary strategies for the~     management of children with MAM on: the children's continued participation in the nutritional~     rehabilitation program and their physical growth, recovery from MAM, and change in~     micronutrient status and body composition. The specific dietary regimens that will be~     compared are: 1) a ready-to-use, lipid-based supplementary food (Plumpy'Sup, Nutriset, Inc.),~     providing ~500 kcal/d for 12 weeks; 2) specially formulated CSB for malnourished children,~     providing ~ 500 kcal/d for 12 weeks; 3) Misola, a locally produced, micronutrient-fortified,~     cereal-legume blend, providing ~500 kcal/d for 12 weeks; or 4) packaged, home available foods~     (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder (Mix~     Me) for 12 weeks, as is currently recommended by the national CMAM protocol when special~     foods are not available.~   "
194625|NCT01015937|"~     The purpose of this study is to investigate whether turmeric is effective in improvement of~     diabetic nephropathy and in decrease in the amount of proteinuria and cytokine levels.~   "
194626|NCT01015924|"~     The purpose of this study is to compare two widely used operative techniques on displaced~     midshaft clavicular fractures. The hypothesis is that there is no difference in functional~     outcome.~   "
194627|NCT01015911|"~     This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of~     SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or~     metastatic renal cell carcinoma.~   "
194628|NCT01015898|"~     The purpose of this study is to evaluate the efficacy of photodynamic therapy in treatment of~     Basal cell carcinoma (BCC) and factors that affect response rate.~   "
194629|NCT01015872|"~     The purpose of this study is to evaluate the relationships between prostanoids and various~     outcomes such as sleep disturbance, hypertension and arteriosclerosis in patients with sleep~     apnea syndrome(SAS). In the patients introduced to continuous positive airway pressure(CPAP)~     treatment, the effects of CPAP are also evaluated.~   "
194630|NCT01015859|"~     The aims of this study are to assess the clinical benefits resulting from SafeR by comparison~     with standard dual chamber programming (DDD) with a long atrioventricular (AV) delay.~      The benefits will be assessed by comparing the percentage of ventricular pacing, the~     incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed~     through echo parameter and atrial natriuretic peptide/brain natriuretic peptide (ANP/BNP)~     measurements.~   "
194631|NCT01015846|"~     This study evaluates the ability of the transverse abdominis (TrA) to contract during and~     after two different types of exercise - either sling based exercise or traditional core~     stability exercise. The TrA is measured by real time ultrasound imaging. The investigators~     hypothesized that the sling based exercise would activate the TrA to a greater degree and~     that there would be a greater activation after the exercise.~   "
194632|NCT01015833|"~     This randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to~     see how well they work compared with sorafenib tosylate alone in treating patients with liver~     cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the~     body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. It is not yet known whether~     giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than~     sorafenib tosylate alone in treating liver cancer.~   "
194633|NCT01015820|"~     Pancreatic cancer is the fourth leading cause of cancer death in the United States and is~     associated with a poor prognosis. The average life expectancy after diagnosis is~     approximately 5 to 8 months. At present, successful surgical resection is the only curative~     therapy that can improve long-term survival. However, it can be achieved only when a tumor is~     detected at an early stage. Unfortunately, due to non-specific symptoms associated with~     pancreatic cancer, it is commonly detected in the later stages of the disease.~      The investigators hypothesized that pancreatic cancer could be detected by measuring the~     changes in the early increase in blood supply (EIBS) found in the surrounding~     normal-appearing duodenal tissue. The investigators tested a device called Four-dimensional~     Elastic Light-Scattering Fingerprinting (4D-ELF). The device used in this study is considered~     investigational, which means it has either not been approved by the Food and Drug~     Administration (FDA) for routine clinical use or for the use described in this study. However~     the FDA allowed the use of this device in this research study.~   "
194634|NCT01015807|"~     The purpose of this study is to determine whether a transversus abdominis plane (TAP) block~     with Clonidine added to the injectate (Clo-TAP) performed approximately 2hrs after the~     cesarean section (CS) will decrease the amount of postoperative hyperalgesia and ultimately~     reduce post-CS chronic pain.~   "
194635|NCT01015794|"~     In this study the investigators aim to quantitate the extent of cervical and upper thoracic~     brown adipose tissue (BAT) activation in lean and obese humans via positron emission~     tomography-computed tomography (PET-CT) in response to the non-specific beta adrenergic~     receptor (AR) agonist ephedrine. The investigators hypothesise that this pharmacological~     adrenergic stimulus will result in activation of BAT in these participants, and that this~     activation will be reduced in obese patients. This study will provide important preliminary~     information with respect to allowing the investigators to progress with longer trials with~     specific beta 3 AR agonists.~   "
194636|NCT01015781|"~     This multi-site study evaluated the implementation of Progressive Tinnitus Management (PTM),~     which combines both Audiology and Psychology approaches to Tinnitus Management. Those~     Veterans who require intervention for tinnitus have different levels of need, and this~     progressive approach gives them the appropriate level of intervention.~   "
194637|NCT01015768|"~     The purpose of this study is to assess corneal staining and to measure the relative corneal~     epithelial barrier function (the degree to which the cornea can prevent penetration of~     colored sodium fluorescein dye into the eye) after 8 hours of wear with a known soft contact~     lens and multipurpose lens care solution combination.~   "
194638|NCT01015755|"~     Patients in Intensive Care Units are often extremely thirsty due to their medicines, illness,~     treatments or medicines that they receive. This study will test whether patients who receive~     a easy to implement intervention for thirst will have greater relief from thirst than a group~     of patients who do not receive the intervention. The study will also identify the most~     important factors that make ICU patients thirsty so that future research studies can test how~     to relieve those factors and/or make interventions for thirst more readily available.~   "
194639|NCT01015742|"~     The purpose of this study is to determine the safety and feasibility of unrelated double~     umbilical cord blood units Transplantation in patients with haematological malignancies using~     Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin,~     methylprednisolone as GVHD prophylaxis.~   "
194640|NCT01015729|"~     The purpose of this study is to investigate whether a fixed dose combination (FDC) capsule of~     esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg has equivalent therapeutic efficacy~     compared to each of 2 free combinations of ASA tablet 81 mg plus esomeprazole 20 mg in~     patients at risk of gastrointestinal events using low dose ASA for cardiovascular protection.~   "
194641|NCT01015716|"~     The purpose of this study is to evaluate whether a 1 year worksite based life-style~     intervention can reduce body weight and increase physical capacity and subsequently reduce~     musculoskeletal disorders and increase workability in overweight health care workers.~   "
194642|NCT01015703|"~     The study is being conducted to explore the safety and tolerability of CoVaccine HT in~     healthy male and female volunteers. In this study volunteers will receive intramuscular~     injections of CoVaccine HT.~   "
194643|NCT01015690|"~     Unexplained fertility could be partly caused by a higher incidence of early pregnancy loss in~     this group. 65 women with unexplained infertility and 65 healthy controls will collect daily~     urine samples form the luteal phase. hCG and creatinine levels are measured in order to~     detect pregnancies and early pregnancy loss.~   "
194644|NCT01015677|"~     This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of~     moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal~     women. The primary study hypothesis is that one or more doses of MK-6913 will result in a~     significantly greater reduction from baseline, compared to placebo, in the number of moderate~     to very severe hot flashes after 4 weeks of treatment.~   "
194661|NCT01015456|"~     To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as~     compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary~     outcomes are complete and partial renal remission, as assessed by renal function, urinary~     sediment and proteinuria in patients with International Society of Nephrology/ Renal~     Pathology Society (ISN/RPS) class III or IV lupus nephritis.~   "
194662|NCT01015443|"~     The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in~     addition to best supportive care is effective in prolonging the lives of Asian subjects with~     unresectable stage III non-small cell lung cancer in comparison to a placebo plus best~     supportive care (a so-called placebo controlled study).~   "
194645|NCT01015664|"~     This study will accrue in two phases. During the first phase of the study, the optimal~     dose of temsirolimus in combination with cisplatin and cetuximab will be determined. It is~     expected that between 9-12 patients will be needed for this dose finding phase. Once the~     optimal dose has been determined, an additional 41 patients will be enrolled in the second~     phase of the study. The primary purpose of second phase of the study is to learn what~     effects, good and/or bad, temsirolimus in combination with cisplatin and cetuximab has on~     recurrent or metastatic head and neck cancer.~      Collection of additional blood and tissue specimens will make it possible to do special~     tests, which will provide us information about how tumors respond to the chemotherapy, how~     your body breaks down and processes the drug, how differences in the genetic makeup of each~     person affects how the drug may work and is processed in the body, and how the drug affects~     proteins and cells in the body. We hope to determine if results of the specialized tests done~     on blood will help to predict which patients are more likely to benefit from the use of the~     drugs used in this study.~   "
194646|NCT01015651|"~     The aim of the study is to assess the accuracy of a new paradigm in measuring the level of~     nociception during lumbar surgery. The paradigm is based the measurement of the baroreflex in~     response to noxious stimuli in anesthetized patients.~   "
194647|NCT01015638|"~     This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy~     volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test~     products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide~     2.5% and the other side of the face will remain non-treated to serve as a control.~   "
194648|NCT01015625|"~     Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of~     local therapy~   "
194649|NCT01015612|"~     To evaluate the performance, efficacy and safety of the percutaneous implantation of the~     CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve~     stenosis that have an elevated surgical risk~   "
194650|NCT01015599|"~     This study presents evaluates the effectiveness of the Healthy Opportunities for Physical~     Activity(HOP'N) After-School Program on preventing obesity in children. The investigators~     hypothesized that normal and overweight/obese children attending after-school sites~     randomized to the control condition will increase in weight status to a greater extent~     compared to children at sites randomized to receive the HOP'N program. The investigators also~     hypothesized that after-school intervention HOP'N sites will increase in physical activity~     and healthful eating opportunities compared to control sites.~   "
194651|NCT01015586|"~     The study will determine if individuals with co-occurring bipolar disorder and alcohol~     dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive~     performance if treated with lamotrigine plus their usual mood stabilizing medications~     relative to subjects treated with placebo plus usual mood stabilizing medications over a 16~     week period.~   "
194652|NCT01015573|"~     The purpose of this study is to create a database of quantified finger movements. Using the~     evaluation system with magnetic sensors, the movements of finger tapping are measured and~     assessed by various indices, such as finger tapping interval, maximum amplitude of finger~     taps, and so on. In this study, the investigators will accumulate the data from healthy~     subjects for the purpose of applying this evaluation system to diagnosis support of nervous~     diseases in the future.~   "
194653|NCT01015560|"~     RATIONALE: Monoclonal antibodies, such MLN1202, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying how well MLN1202 works in treating patients with~     bone metastases.~   "
194654|NCT01015547|"~     The objective of this study is to compare in very early polyarticular juvenile idiopathic~     arthritis (JIA) the efficacy, safety, and cost-benefit-ratio of three treatment strategies:~     biologic combination, combination of conventional disease-modifying drugs (DMARDs), and~     methotrexate alone.~   "
194655|NCT01015534|"~     RATIONALE~        -  Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High~          daily dose temozolomide combined with fractionated radiotherapy may make tumor cells~          more sensible to treatment.~      PURPOSE~        -  This randomized phase II trial, assess in patients with brain metastases from solid~          tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve~          the results obtained with WBRT.~   "
194656|NCT01015521|"~     This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative~     and ER+ breast cancer.~   "
194657|NCT01015508|"~     To demonstrate differences in response of subjects with a high, low or medium predisposition~     for weight regain after weight reduction in terms of: body composition; energy expenditure;~     physical activity; and adipogenic capacity.~   "
194658|NCT01015495|"~     The purpose of this study is to determine whether injections of ranibizumab into the eye are~     safe and well tolerated when given to subjects in multiple doses.~   "
194659|NCT01015482|"~     Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and~     leads to deterioration of quality of life. An injury or wound can lead to long term changes~     in the nervous system that make the skin more sensitive at and near the injury; this is~     termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the~     synaptic interaction between neurons.~      Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in~     animal studies the investigators have discovered previously unrecognized effects of opioids.~      UV-B irradaition of the skin of the thigh is an established model of priamary and secondary~     hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an~     ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human~     volunteers in a double blind cross-over prospective active placebo controlled clinical trial,~     at a dose corresponding to 0.7 µg kg-1 min-1.~   "
194660|NCT01015469|"~     Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY).~      The aim of this novel study is to evaluate, if an additional restrictive silastic ring can~     avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive~     better postoperative weight loss and significantly improved long-term weight maintenance.~      The study will not investigate the GaBP-Ring as medical product but the effect of the~     GaBP-Ring on weight loss in comparison to gastric bypass alone.~   "
194663|NCT01015430|"~     This randomized, double-blind multiple ascending dose study will evaluate the safety and~     tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome.~     The patients will be randomized to receive either active drug or placebo. The anticipated~     time on study treatment is 6 weeks. The target sample size is <100 patients.~   "
194664|NCT01015417|"~     Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic~     cholecystitis little or moderately severe, is effective and therefore justified.~      The main objective is to compare the occurrence of postoperative infectious complications~     including surgical site infections (SSI) and remote infections after early cholecystectomy~     (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC)~     little or moderately serious (without organ dysfunction) with and without postoperative~     antibiotics.~      The secondary objectives are:~        -  Rates of infectious complications according to duration of preoperative antibiotic~        -  Influence of surgical drainage after surgery for occurrence of postoperative infectious~          complications~        -  Analysis of the nature of infectious complications (surgical site infections, remote~          surgical site infections)~        -  Comparison of germs found in the bile during the postoperative infectious complications~        -  Duration of hospitalization~        -  Readmission rate for surgical site infections~        -  Rate of reoperation for surgical site infection~        -  Overall mortality rate at 30 days~        -  Mortality rates specific to 30 days~   "
194665|NCT01015404|"~     This study aims to investigate the safety in using Trafermin (recombinant human basic~     fibroblast growth factor) with periodontal surgery.~   "
194666|NCT01015391|"~     The purpose of this study is to see whether T2 versus Azathioprine is able to maintain the~     clinical and endoscopic remission in subjects with Crohn's disease after surgery-induced~     remission.~      The side effects related to T2 and AZA will also be monitored throughout the study.~   "
194667|NCT01015378|"~     Aim: This is a longitudinal cohort study to assess long-term clinical outcome of patients who~     were admitted in our institution for a first episode of uncomplicated sigmoid diverticulitis.~      Methods: All patients who were diagnosed with a first episode of sigmoid diverticulitis will~     be evaluated for inclusion in the study, pending informed consent. Those patients who have~     evidence of complicated diverticulitis (fistula, abscess) will receive a recommendation to~     undergo elective sigmoid resection, while those who have a simple attack will be recruited in~     the cohort. Follow-up will be performed at yearly intervals through telephone interview with~     the patient. The duration of study is expected to last 10 years (2010-2020), with >50 new~     patients/year, for a total of >500 patients.~      Endpoints:~        1. the occurrence of a second episode of diverticulitis~        2. severity and outcome of recurrent diverticulitis~        3. evolution in digestive symptoms and quality of life (QoL)~        4. need for subsequent elective or emergency sigmoid resection~      Rationale: This study will help in determining the risk/benefit of the current approach for~     this common condition, which is to manage patients conservatively with antibiotics and adopt~     a wait-and-see attitude. Specifically, the following events will be assessed quantitatively:~        -  the rate of relapse in an urban community.~        -  the burden of this common disease on QoL and digestive function~        -  the percentage of patients who may need emergency surgery~   "
194668|NCT01015365|"~     The investigators hypothesise that cementless one-stage exchange revision surgery can be~     performed in patients with chronically infected hip replacement with substantial benefits for~     the patients, in terms of fast rehabilitation, low re-revision rates and good long term~     results.~   "
194669|NCT01015352|"~     The study is aimed to treat low-risk MDS patients,who are dependent on red-blood cell~     transfusion due to disease-related anemia, and who have a proven resistance towards treatment~     with erythropoetin-stimulating agents (ESA). The study randomizes patients to receive a~     treatment with the demethylating agent 5-azacytidine alone or in combination with an ESA. The~     study thus evaluates, if efficacy of 5-azacytidine, notably on the red-blood cell~     transfusion-dependence is comparable/inferior to a combination treatment with azacitidine and~     an ESA (that is if 5-azacytidine can overcome the resistance towards ESA). Being a phase II~     study, the study assesses, duration of erythroid response, overall survival and time to~     progression as well as toxicity.~   "
194670|NCT01015339|"~     The purpose of this study is to investigate whether Paclitaxel Plus Capecitabine With~     Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is~     effective and safe.~   "
194671|NCT01015326|"~     Epidermal Growth Factor Receptor Inhibitors (EGFRI) are associated with skin toxicities.~     Clinical experience suggests that skin toxicities interfere with health related quality of~     life (HRQL) and may interfere with treatment adherence. No systematic investigations of~     EGFRI-associated dermatologic toxicities and impact on HRQL have been reported. No~     patient-reported outcome measures exist to capture the unique concerns of oncology patients~     who experience EGFRI-associated dermatologic toxicities.~      The purpose of this study is to develop a patient-reported outcomes measure to assess~     dermatologic-related symptoms burden and health-related quality of life among patients~     receiving an EGFRI, and to develop a grading system for EGFRI-associated dermatologic~     toxicities.~   "
194672|NCT01015313|"~     The primary aim of this study is to investigate whether intensive sodium management by~     dietary sodium restriction and by preventing positive sodium balance during dialysis can be~     successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium~     restriction has positive effects on the frequency of hospital admissions, blood pressure,~     fluid overload, quality of life and residual renal function.~   "
194673|NCT01015300|"~     Von Hippel-Lindau (VHL) disease is an inherited syndrome manifested by a variety of benign~     and malignant tumors. Hemangioblastomas are the most common lesion associated with VHL~     disease affecting 60-84% of patients with a mean age at diagnosis of 29 years. Standard~     treatment for this disease is by surgery or radiotherapy. No approved systemic therapy yet~     exists. Patients with VHL have an increased growth factor production, specifically vascular~     endothelial growth factor (VEGF), resulting in angiogenesis (growth of blood vessels).~     Studies show that Bevacizumab inhibits the growth of VEGF protein and will block the~     VEGF-driven angiogenesis and result in stabilization and regression of hemangioblastomas in~     VHL disease patients. The dose of bevacizumab will be 10 mg/kg every two weeks for up to 6~     months.~   "
194675|NCT01015274|"~     The long-term objective of this research is to develop a non-invasive approach for early~     assessment of which patients are at high risk for future development of skeletal muscle~     atrophy. The investigators hypothesize that the rate constant for the terminal portion of the~     isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine~     (D-3MH) provides an accurate measure of this increased risk and that this rate constant can~     be measured non-invasively from timed spot urine samples.~   "
194676|NCT01015261|"~     Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be~     screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day~     1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14~     patients will be randomized in two group. BMT group who have donor and Chemotherapy group who~     don't have suitable donor. BMT group treated with allogenic Bone Marrow Transplantation and~     Chemotherapy treated with Cyclophosphamide at day 15, Daunorubicin at day 15-18, Vincristine~     at day 15 and 22 and Dexamethasone at day 12-28 followed by standard chemotherapy. In BMT~     group patients will be received CNS radiotherapy at +100 day after transplantation.~   "
194677|NCT01015248|"~     The aim of the study is to assess the therapeutic activity and safety of the combination of~     Bendamustine and Rituximab in MALT lymphomas.~      Primary endpoint:~        -  Event-free-survival (EFS) (failure or death from any cause) for all patients.~      Secondary endpoints:~        -  Complete and partial remission rates for all patients~        -  Response duration (time to relapse or progression) for responder patients~        -  Progression-free-survival (PFS) (disease progression or death from lymphoma: for all~          patients~        -  Overall survival for all patients~        -  Acute and long-term toxicity~   "
194678|NCT01015235|"~     The purpose of this study is to determine whether KAI-1678 is effective in the treatment of~     postoperative pain following total hip or total knee replacement.~   "
194679|NCT01015222|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of dasatinib, bevacizumab, and paclitaxel with or without Methylnaltrexone that~     can be given to patients with advanced cancer. The safety of this drug combination will also~     be studied.~   "
194680|NCT01015209|"~     The dry eye syndrome DES is a highly prevalent ocular disease, in particular in the elderly~     population. One mainstay of therapy for patients suffering from DES is the use of topically~     administered lubricants. However, despite many efforts, no ideal formulation has yet been~     found.~      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for~     treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with~     favourable biological properties such as high biocompatibility and low toxicity.~     Additionally, the new formulation comprises N-acetylcysteine, which has been used in~     ophthalmology because of its mucolytic properties for several years. Based on theoretical~     considerations, one can hypothesize that the new chitosan derivative may show an increased~     adhesion to mucins of the ocular surface and may therefore be particularly beneficial in~     reducing the symptoms associated with DES.~   "
194681|NCT01015196|"~     First randomization:~      After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all~     courses of chemotherapy (induction, consolidation courses before ASCT)~      Second randomization:~      After achieving 1st CR: all patients received non intensive consolidation course Familial HLA~     typing required for all patients~      Patients with HLA-identical sibling:~      Patients with very good prognostic factors (CBF leukemias, WBC < 30 giga/l at diagnosis, 1st~     CR after one induction course) = arm C: no allogeneic stem cell transplantation in 1st CR;~     received 2 more courses of intensive consolidation chemotherapy All others patients received~     an allogeneic transplant For patients aged less than 51 = arm M: upfront myeloablative~     conditioning regimen For patients aged over 51 and less than 61= arm m: intensive~     chemotherapy consolidation course.~   "
194682|NCT01015183|"~     In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention~     mucositis due to high dose chemotherapy in the patients undergoing bone marrow~     transplantation whose received Busulfan and/or Cyclophosphamide. Patients randomized in two~     groups: intervention and control with balanced block randomization method. Intervention group~     received Zinc sulfate immediately after start conditioning regimen and continued for two~     weeks. Control group received placebo at the same manner. Prevalence and severity of~     mucositis will be compared in two groups.~   "
194683|NCT01015170|"~     Despite the significant health, social and economic costs of cigarette smoking, 17% of~     Ontarians still currently smoke. Use of smoking cessation pharmacotherapy such as Zyban~     (bupropion HCl) has been shown to double quit rates but such medications are under-utilized~     by smokers attempting to quit. It has been suggested that the high price of pharmacotherapy~     may act as a barrier to accessing such treatment.The main objective of this study is to~     evaluate the methods and effectiveness of providing smokers who want to quit with 8 weeks of~     free Zyban in combination with smoking cessation counselling through family health teams and~     community health centres across the province.~      Hypothesis: Ontario smokers who receive 8-weeks of free bupropion in combination with brief~     counselling will have higher smoking cessation rates than the standard population cessation~     rates.~   "
194684|NCT01015157|"~     Study objectives :~      Primary endpoint is to a assess the change in blood loss (originating from stapling the~     stomach) with the use of Seamguard reinforcement Secondary endpoint is to evaluate the~     difference in leak rate~      Methods :~      Prospective. Randomized study. Published data does not allow for clear determination of the~     number of patients required for the study. Based on our own experience. The investigators~     estimate that the average postoperative blood loss is 200ml with a standard deviation of~     100ml over 3 days. Based on this assumption. A total number of patients (control + Seamguard~     groups) of 60 is required if the expected reduction of the mean drainage volume is 100ml and~     82 patients for an expected drainage volume reduction of 85ml.~      All patients candidates to a laparoscopic gastric bypass will be enrolled in the study Under~     the conditions this is a primary bariatric procedure (no revision allowed)., no history of~     hiatal surgery such as anti-reflux nor significant upper abdominal surgery. The only~     associated surgical procedure allowed is the cholecystectomy.~      Patients' inclusion :~      Will be done immediately before surgical procedure following acceptance of a written consent.~      Bleeding from liver or slpeen injury will lead to patient's exclusion.~      Methods :~      Surgical procedures are identical for the 2 surgeons of the study (GB and PT) with 30-50ml~     gastric pouch. Linear. side to side. Antegastric and antecolic gastrojejunal anstomosis . Use~     of Echelon 60 linear stapler with GOLD cartridges on stomach. Blue to perform the~     gastrojejunal anastomosis and white on Small bowel. Peroperativeblood loss and need to apply~     clips or stitches on the gastric staple line are recorded. Operation time and patient~     information (BMI. Comorbidities) are recorded as well any noticeable or unexpected event.~      Postoperative blood loss is assessed by at least 1 abdominal closed circuit suction drain~     left for a minimum of 3 days (removal on postop day 3 at the earliest).~      In addition hemoglobin and red cell count is performed on postop day 1 and 2. Absence of~     leakage is confirmed by methylene blue test perop as well as on postop day 1 before resuming~     fluids and on postop day 2 by a gastrograffin swallow. Drinks and food are resumed according~     to the standard practice between postop day 1 and postop day 2.~      Duration of the hospital stay and postoperative course will be documented. Early follow up is~     clinically done at 1 month postop without any specific radiological or biological~     examination.~      Data collection Will be done on a form during and after the procedure~      BLOOD LOSS : peroperative volume as well as daily drainage output (postop day 1. 2 and 3) as~     well as the sum of the 3 postop days.~      Hemoglobin change is recorded on day 1 and 2. Need to leave drain(s) for more than 3 days is~     recorded.~      Study completion :~      Estimated time to complete the study based on the current experience is between 5 and 7~     months. Sudy is closed 1 month after the last inclusion.~   "
194685|NCT01015144|"~     The aim of the study was to assess of the influence of atorvastatin on selected indicators of~     an inflammatory condition, function of the left ventricle and factors affecting the~     occurrence of undesired events like rehospitalizations and mortality in patients with dilated~     cardiomyopathy.~   "
194686|NCT01015131|"~     This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell~     proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'[18F]-fluorothymidine~     (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy~     in participants with breast cancer.~   "
194687|NCT01015118|"~     The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and~     carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in~     first-line treatment of patients with advanced ovarian cancer. Safety information about~     BIBF1120/paclitaxel/carboplatin will be obtained.~   "
194688|NCT01015105|"~     The aims of this study is to study the occurrence of the troponin elevations, ECG changes,~     and cardiac symptoms in unselected consecutive patients with hip fracture.~      Followup will be carried out up to one year period.~   "
194690|NCT01015079|"~     To investigate the protective effect of cervical cancer incidence and mortality by screening~     attending frequency or screening pattern, and to evaluate the possible risk of developing~     malignancies among women with cervical lesions, inflammation or infection.~   "
194691|NCT01015066|"~     This study is designed to determine the relative effectiveness of buprenorphine/naloxone~     (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse~     prevention and opioid craving reduction among opioid-dependent adolescents and young adults.~     The investigators hypothesize that naltrexone treatment is as effective as~     buprenorphine/naloxone for these treatment outcomes.~   "
194692|NCT01015053|"~     The purpose of this study is to compare the use of ultrasound-guided bilateral rectus sheath~     blocks to local infiltration of anesthetic agent in the surgical wound in a pediatric~     population of patients undergoing umbilical hernia repair.~   "
194693|NCT01015040|"~     The objective of the study is to compare the relative bioavailability and pharmacokinetics of~     solifenacin succinate suspension versus tablet.~   "
194694|NCT01015027|"~     This study will test the safety and tolerability (how the body reacts to the drug) of REGN668~     and placebo (an inactive substance that contains no medicine) in healthy subjects.~   "
194695|NCT01015014|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile~     of an antibacterial compound for treatment of hospital acquired Gram negative infection.~   "
194696|NCT01015001|"~     The primary outcome of this study is to evaluate the effects of low frequency subthreshold~     repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of~     patients with refractory schizophrenia on the severity of auditory hallucinations.~      The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of~     life, functionality and general psychopathology.~   "
194697|NCT01014988|"~     The purpose of this study is to determine whether zanamivir aqueous solution given by~     intravenous injection is safe in treating hospitalized patients with confirmed influenza~     infection. A single arm open-label design has been selected to achieve the primary objective~     of providing regulatory authorities with safety data on IV zanamivir.~   "
194698|NCT01014975|"~     This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the~     middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot~     component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter~     to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg,~     and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by~     imaging of the affected artery and functional testing.~   "
194699|NCT01014962|"~     The purpose of this study is to determine an upper dose of albaconzole to be administered in~     a Thorough QTc study.~   "
194700|NCT01014949|"~     Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes~     and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear.~     The aim of this study is to invasively assess coronary microcirculation and to investigate~     the relationship of insulin resistance with coronary microvascular dysfunction.~      A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries~     without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will~     be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a~     5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR)~     will be calculated as the distal coronary pressure at maximal hyperemia divided by the~     inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal~     hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA)~     index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood~     examinations before the procedure.~   "
194701|NCT01014936|"~     This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore~     MSC2156119J, in subjects with advanced solid tumors who have not responded to previous~     therapies or for whom no other therapies are available.~      Subjects will be assigned one of the dosing regimens:~        -  Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment~          (21-day cycle)~        -  Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks~          (21-day cycle)~        -  Regimen 3: MSC2156119J every day for three weeks (21-day cycle)~   "
194702|NCT01014923|"~     We hypothesize that this intervention will increase the quality and quantity of parental~     interaction on safety driving with newly-licensed teen drivers. 250 parent/teen dyads will be~     individually randomized into intervention and control groups. The intervention group will~     receive a tailored, in-person intervention with a trained member of the research team, with~     follow-up intervention phone calls each month for the 3-month intervention. The control group~     will be a usual care group who will receive driving safety materials available to all new~     drivers and their parents. Parents and teens will be followed to see if intervention parents~     meet the intervention's driving goals and to see if the parent and teens report improved~     driving skills and behaviors in the intervention compared with the control group.~   "
194703|NCT01014910|"~     Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome cause by different types~     of viruses and occurs in young children. Although bronchiolitis is a widespread and fairly~     common illness in children, pediatricians vary significantly in how it is treated. This~     includes how children are monitored for their oxygen status when not receiving supplemental~     oxygen. Studies suggest that continuous pulse oximetry measurement of children admitted to~     the hospital with bronchiolitis regardless of use of supplemental oxygen prolongs their~     hospital stay. This increases the cost of care for these patients and increases their risk of~     hospital-associated complications.~      This study is a randomized trial of continuous pulse oximeter use in patients admitted with~     bronchiolitis versus transitioning patients not requiring oxygen to intermittent pulse~     oximetry monitoring. The investigators hypothesize that this will decrease length of stay as~     well as associated costs of care and number of medical interventions performed in the~     hospital.~   "
194704|NCT01014897|"~     The hypothesis of this study is that different subgroups of stroke will respond differently~     to direct current stimulation.~   "
194857|NCT01012895|"~     The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination~     alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in~     the treatment of Hepatitis C in patients who have not responded to prior therapy.~   "
194705|NCT01014884|"~     The investigators are studying the impact of the interventions of a multidisciplinary team~     (MDT) - consisting of a Coventry case manager, social worker, and medical director, alongside~     a Medco specialist pharmacist - on the hospitalization rates of high risk seniors with~     chronic conditions, compared with a usual care approach. The study will also examine the~     impact on quality of life, medication adherence, medical costs, hospital readmission rates,~     and a variety of other important measures. The outcome of COSS may support a means to further~     enhance and develop a comprehensive care model program by leveraging the partnership between~     a health plan and a pharmacy benefit manager.~   "
194706|NCT01014871|"~     Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison~     study in subjects with moderate to severe forehead wrinkles.~      One botulinum toxin type A will be injected in one side of the forehead and the other one~     will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to~     each side of the forehead will be randomized.~   "
194707|NCT01014858|"~     To demonstrate the superiority of donepezil over placebo in improving cognitive function,~     neuropsychiatric burden and functional ability in people with Parkinson's disease and mild~     dementia after 24 months of treatment.~      To demonstrate the superiority of donepezil over placebo in improving patient and carer~     quality of life and to establish the cost-effectiveness of donepezil.~      To determine the instrument most suitable for evaluating change in cognition in people with~     Parkinson's disease and mild dementia.~   "
194708|NCT01014845|"~     The primary purpose of this study is to determine whether the preventive hepatitis E are~     effective in the prevention of hepatitis E occurring at least 30 days after the~     administration of the third dose of vaccine.~      The secondary purpose of this study is to to evaluate the safety and immunogenicity and~     immunopersistence of the study vaccine.~      The initial study is planed to be ended on month 19 and the results were analysed and used~     for registration purpose. The extended study will be continued to assess the long-term~     efficacy, immunogenicity and safety.~   "
194709|NCT01014832|"~     The purpose of this study is to evaluate the efficacy and safety of frequently modified~     intensive insulin therapy in patients with Type-2 and Type-1 diabetes mellitus.~   "
194710|NCT01014819|"~     The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the~     skin's normal electric field and this abnormal electric field can be detected by the~     Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can~     provide useful data to guide in the diagnosis of skin disease.~   "
194711|NCT01014806|"~     -  To assess the tolerability and safety of a single injection of Influenza VLP Vaccine~          when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain.~        -  To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA~          per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of~          the component viral strains [A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and~          B/Brisbane/60/2008].~   "
194712|NCT01014793|"~     In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin~     analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy~     with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This~     study was designed to evaluate short and long term efficacy of cabergoline in controlling~     IGF-I levels in acromegalic patients receiving octreotide.~   "
194713|NCT01014780|"~     The aim of this investigation is to determine the thickness of the human preocular tear film~     using a new method based on laser speckle. This will be a preliminary study to generate~     normative tear film thickness data in normal (i.e., non dry eye) and dry eye subjects in a~     clinic-based population. In addition, we will examine the short term (i.e., one week)~     repeatability of the method in a single setting.~      The patients classified as having dry eye will also have their tear film thickness measured~     after instillation of an artificial tear. This will potentially reveal valuable data in~     retention of effect measured non-invasively as in prior studies that employed a fluorescein~     tracer.~   "
194714|NCT01014767|"~     This is a tissue banking and data review research study that also has a clinical research~     part:~        -  The goal of the tissue banking part of this study is to store tissue in a research~          tissue bank by the International Society for Pediatric Oncology (SIOP) at an~          international reference center for choroid plexus tumors. The tissue will be used in~          future research related to cancer.~        -  The goal of the data review part of this study is to collect information from the~          medical records of patients with choroid plexus tumors, and to store the information in~          SIOP databases for use in future research related to cancer.~        -  The goal of this clinical research study is to compare 4 chemotherapy treatments for~          choroid plexus tumors. The safety and level of effectiveness of these study treatments~          will be compared and studied. The study drugs include different combinations of~          etoposide, carboplatin, vincristine, cyclophosphamide, methotrexate, doxorubicin,~          cisplatin, dactinomycin, temozolomide, and irinotecan.~   "
194727|NCT01014598|"~     This phase I trial studies the side effects and best dose of cisplatin in treating patients~     with stage IIIB-IV non-small cell lung cancer or tumors that have spread from where they~     started to the lung (metastasis). Drugs used in chemotherapy, such as cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving cisplatin directly into the~     arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.~   "
194728|NCT01014585|"~     The purpose of this study is to evaluate the durability of effect of milnacipran for the~     treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to~     characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated~     by changes in symptoms following the discontinuation of milnacipran.~   "
194729|NCT01014572|"~     The purpose of this study is to determine whether an investigational drug (Alagebrium~     (generic: ALT-711), a type of medication referred to as an advanced glycaton end-product~     clever) can be combined with exercise training to reverse the stiffening of the heart that~     takes place naturally with aging.~   "
194730|NCT01014559|"~     The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged~     release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the~     reduction of the intensity of opioid-induced constipation symptoms in patients treated for~     cancer or non-cancer pain.~   "
194715|NCT01014754|"~     The primary objective of this study is to determine any causative or associated factors for~     the development of Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy~     (NFD), or related diagnosis. Our primary focus will be on the previous administration of~     gadolinium to these patients, but we will also look at other postulated causes and risk~     factors.~      The secondary objective of this study is to assess tissue gadolinium (Gd) levels in five~     groups of subjects:~        -  Those affected by NSF.~        -  Those with normal kidney function who have undergone a medical imaging procedure using~          Gd-based contrast agent (GBCA) in the 2 years prior to a skin biopsy.~        -  Those with normal kidney function who have never been exposed to GBCA and have had a~          skin biopsy.~        -  Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have had a medical imaging~          procedure using GBCA in the 2 years prior to skin biopsy.~        -  Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have never been exposed to GBCA~          and have had skin biopsy.~      We hypothesize that there is a correlation between the administration of Gd-containing agents~     usually associated with MRI procedures and the development of NSF in those with renal failure~     and some other predisposing condition. We also hypothesize that tissue Gd levels in those~     with NSF will be higher than in those who have been exposed to GBCA but do not have NSF. Of~     the two groups without NSF but with exposure to GBCA, we hypothesize that those with kidney~     dysfunction will have higher tissue Gd levels than those with normal kidney function. We~     hypothesize that in the two groups of subjects without exposure to GBCA, there will be no~     detectable levels of Gd, regardless of kidney function status.~   "
194716|NCT01014741|"~     Procedures for ablation of persistent or long lasting atrial fibrillation are frequently long~     and require extensive ablation. Some electrophysiologists administer the drug ibutilide~     during these procedures to help organize the fibrillatory activity of the left atrium with~     the hope that this may shorten the length of the procedure and duration of ablation needed.~     Currently there is no standardized approach of administering the drug ibutilide during these~     procedures, thus the investigators cannot be certain that administering this drug does in~     fact facilitate the procedure. The aim of the MAGIC-AF Trial is to see if administering a~     standard dose of the drug ibutilide at a standard time in the procedure can allow for a~     reduction in the ablation procedure time. The investigators hypothesize that administering~     ibutilide during these procedures will result in a reduction in the procedure and ablation~     time required.~   "
194717|NCT01014728|"~     The purpose of this study is to compare the blood loss during sinus surgery looking at two~     different types of anesthesia: either intravenous anesthesia with propofol or inhalational~     anesthesia with sevoflurane.~   "
194718|NCT01014715|"~     The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy~     is performed. By administering the PBI before the lumpectomy, a smaller volume of breast~     tissue may be exposed to radiation. The PBI method used in this study is 3D (three~     dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses~     an x-ray beam to deliver the radiation dose. Approximately 3 weeks after completion of the~     PBI, the cancer will be surgically removed.~      This study will learn about the good and bad effects of 3D-conformal external beam~     irradiation PBI when given before the cancer has been removed by lumpectomy. The study will~     also learn about the feelings women have about how their breast looks after PBI and surgery.~   "
194719|NCT01014702|"~     The LensAR Laser System is used to create an opening in the anterior capsule of the lens and~     fragments the cataractous lens. The study will evaluate clinical outcomes compared to the~     contra-lateral eye treated with conventional phacoemulsification surgery.~   "
194720|NCT01014689|"~     Randomized, controlled, multi-center, double-blind, parallel-group comparison study in~     Subjects with moderate to severe acne vulgaris on the face.~      The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide~     (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl~     Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of~     moderate to severe acne vulgaris.~      The safety of the two treatment regimens will also be evaluated.~   "
194721|NCT01014676|"~     The purpose of this study is to evaluate the effect of regular consumption of probiotic milk~     in preventing illnesses in Finnish children attending day care centres, and possible~     cost-benefits that could be associated with fewer illnesses.~   "
194722|NCT01014663|"~     The primary purpose of this study is to compare the effects of a non-traditional boxing~     training program to a traditional therapeutic exercise program on activity and participation~     outcomes in persons with Parkinson's disease. Thirty participants will be randomly assigned~     to participate in either non-contact boxing training or traditional therapeutic exercise for~     36 sessions over 12 weeks. Participants will be measured immediately before (pre-test) and~     after (post-test) the intervention.~   "
194723|NCT01014650|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a~     single IV dose of GLYX-13, an N-Methyl-D-aspartate (NMDA) receptor glycine site functional~     partial agonist, in normal, healthy human volunteers.~   "
194724|NCT01014637|"~     The purpose of the study is to evaluate and compare the efficacy of the sequential~     association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8%~     film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients~     with dermatophytic onychomycosis (toenail) without matrix involvement.~   "
194725|NCT01014624|"~     The primary objective of the study is to describe the cumulative proportion of subjects who~     return to baseline platelet P2Y12 receptor function over time (up to 12 days post last~     maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by~     Accumetrics VerifyNow P2Y12 reaction units (PRU) and described by Kaplan Meier curves. The~     primary analysis is descriptive and is intended to provide information relating to the return~     of baseline platelet function following discontinuation of maintenance therapy with either~     prasugrel or clopidogrel.~   "
194726|NCT01014611|"~     The aim of this project is to investigate the impact of heart failure (HF) on calcium~     homeostasis, mitochondrial function and oxidative stress in human skeletal muscle, before and~     after exercise training. The role playing by circulating factors such as cytokines and~     catecholamines will also be evaluated.~      24 HF patients will be enrolled in the study: 12 class II NYHA HF volunteers with a fraction~     of ejection between 40% and 30 %, and 12 class III NYHA HF volunteers with a fraction of~     ejection lower than 30 %. They will be compared to 24 sedentary healthy volunteers, matched~     on age and physical activity.~   "
194731|NCT01014546|"~     This phase I trial studies the side effects and best dose of arsenic trioxide with or without~     ascorbic acid in treating patients with myelofibrosis. Drugs used in chemotherapy, such as~     arsenic trioxide, work in different ways to stop the growth of cancer cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     arsenic acid together with ascorbic acid may kill more cancer cells.~   "
194732|NCT01014533|"~     Insomnia and other sleep abnormalities are common, persistent, and associated with relapse in~     alcohol-dependent patients. The overall, long-term objectives of the proposed research are to~     investigate the neurophysiologic mechanisms of sleep disturbance that are associated with~     relapse in patients with alcohol dependence, and to target those mechanisms with medication~     in order to reduce relapse risk.~      The specific research aims are:~        1. To investigate three potential mechanisms of sleep disturbance in alcoholic patients:~          impaired sleep drive, impaired circadian regulation of alertness, and brain~          hyperactivation;~        2. To investigate short-term effects of medication on sleep and its regulatory mechanisms~          in alcoholics;~        3. To investigate the short-term clinical course of alcoholism as a function of baseline~          sleep parameters.~      In Study Phases I & II (Screening & Baseline: 10+ days), subjects are assessed to diagnose~     alcohol dependence, determine baseline values for drinking and sleeping, and rule out~     confounding sleep-impairing causes.~      Phase III (Medication: 10 days), is a randomized, double-blind parallel design comparison of~     gabapentin vs. placebo on mechanisms of sleep. It is not a therapeutic or clinical trial.~     Phases II & III each have 7 days of monitoring sleep and activity, followed by 3 nights in~     the University of Michigan (UM) sleep laboratory to assess all-night EEG activity and~     Dim-Light Melatonin Onset (DLMO), a measure of circadian rhythm.~      Phase IV is a 2-day medication taper and Phase V (Follow-up) consists of one visit or~     telephone call after 12 weeks to assess course of drinking.~      In summary, sleep disturbance in alcoholic patients increases their risk of relapse. This~     study proposes to investigate the mechanisms causing sleep disturbance in alcoholics and to~     determine if those mechanisms predict return to drinking after 12 weeks.~      Relevance: Alcoholism is a devastating chronic disorder that in any one year affects 10% of~     adults, costs over $185 billion, and causes more than 100,000 deaths in the U.S. Despite~     treatment, most alcoholic patients achieve only short-term abstinence. Medically-based~     treatment improvements are needed that target neurophysiologic mechanisms of relapse. Overall~     public health will be improved by developing science-based treatments that can augment~     existing, but only partially effective, treatment approaches.~   "
194733|NCT01014520|"~     The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive~     analgesia to reduce postoperative pain after lumbar diskectomies.~   "
194734|NCT01014507|"~     This study is designed to test the the protective capacity of Goserelin compared with oral~     contraceptive~   "
194735|NCT01014494|"~     This study is being undertaken to verify the safety and performance of Adaprev™, a Class III~     medical device, when administered as a short term implant into the tendon sheath at the time~     of surgery, on the post-operative function of severed digital tendons. Subjects are~     randomised to either Adaprev or standard care and attend visits for 26 weeks following~     surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical~     trial sites.~   "
194736|NCT01014481|"~     To study the optimal timing to initiate antiretroviral therapy in HIV-infected patients who~     are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis~     treatment by comparing the composite end point of death rate, hospitalization rate and~     adverse drug reactions at week 48, 96 and 144.~   "
194737|NCT01014468|"~     To report the short term anatomic and visual acuity response after intravitreal injection of~     bevacizumab and ranibizumab in patients with choroidal neovascularization secondary to~     age-related macular degeneration.~   "
194738|NCT01014455|"~     Smoking causes 90% of all lung cancer deaths among men and 80% of lung cancer deaths in~     women. Surgery is a great opportunity to help patients quit smoking. Smokers are at increased~     risk for heart, lung, and wound complications around the time of surgery. Even a brief~     abstinence from smoking can produce benefits. Surgery can also motivate smokers to quit~     spontaneously. If the investigators can take advantage of this great opportunity, they may be~     able to help many smokers quit using simple means. However, currently most smokers continue~     to smoke cigarette on the morning before surgery, as shown by the measurement of exhaled~     carbon monoxide (CO) on the morning of surgery. CO is one of the many poisons in cigarette~     smoke. It only stays in the body for a few hours. By asking smokers to blow into a small~     machine, the investigators can test the CO level in the smokers' body and thus know if they~     have just smoked within the past few hours. The goal of this study is to determine the role~     of carbon monoxide monitoring as a means to decrease cigarette smoking before surgery. The~     investigators will identify a group of smokers who are scheduled for surgery and invite them~     to participate. One or two days before surgery, half of the patients will receive a brief~     advice about quit smoking. The other half of patients will be told that their CO will be~     checked before surgery, in addition to the brief advice. On the morning of surgery, the~     investigators will then check their CO level to determine if they have followed the advice.~     In order to have a better understanding about the factors influencing patients' intent to~     quit smoking, the investigators will ask all study participants to fill out a questionnaire.~     The questionnaire is constructed according to behavioral theories which provide good~     framework for studying people's intent and behavior. If the investigators are successful,~     they will determine how much of an impact the message of CO testing has on smoking before~     surgery. The investigators will also gain insights into facilitators and barriers to smoking~     cessation around the time of surgery. The brief intervention evaluated in this study has~     potential to be disseminated and to promote the long term health of surgical patients.~   "
194739|NCT01014442|"~     This open-label, single center study will assess the pharmacokinetics, efficacy and safety of~     mycophenolate mofetil in lung allograft recipients. Participants will be split into 2 groups~     according to the original disease: Group A (cystic fibrosis) and Group B (chronic obstructive~     pulmonary disease [COPD], emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin~     deficiency [A1AD]). All participants will receive mycophenolate mofetil orally, 1.5 grams (g)~     twice daily (BID) from Day 2 to 30 post transplantation, and 1 g BID from Day 31 to 90 post~     transplantation. Anticipated time on study treatment is 90 days, and target sample size is~     50-100 individuals.~   "
194740|NCT01014429|"~     The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a~     polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.~   "
194741|NCT01014416|"~     To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15,~     30 and 60 mg after single oral administration in healthy Korean male subjects.~   "
194742|NCT01014403|"~     Brain injured patients are at high risk for forming blood clots in the legs and lungs. For~     non-brain injured trauma patients, we decrease the chances of these blood clots forming by~     placing the patients on a low dose of the blood thinner enoxaparin. Starting patients with a~     brain injury on the blood thinner is problematic, however, as this can theoretically cause~     the brain injury to worsen. Trauma surgeons wait a variable period of time before starting~     this blood thinner because waiting too long can result in the formation of these blood clots~     in the legs and lungs. Previous research has shown that some brain injuries which are of~     lower severity can have enoxaparin started at 24 hours after injury if the brain injury is~     stable on a repeated computed tomography (CT) scan of the head. This is a pilot study~     designed to look at the rates of worsening of brain injury if the low dose blood thinner is~     started at 24 versus 96 hours post-injury.~   "
194743|NCT01014390|"~     The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary~     RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct~     strictures.~   "
194745|NCT01014364|"~     The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is~     rapidly progressing worldwide and a substantial number of patients get severe H1N1 related~     pneumonia that requires mechanical ventilation and admission to the intensive care unit. The~     acute respiratory distress syndrome is associated with a substantial mortality and morbidity~     partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are~     trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these~     drugs may cause super infection or metabolic disorders. Thus, there is a need for a~     randomized double blind, placebo controlled trial to define the benefit to risk ratio of~     corticosteroids in this patient.~   "
194746|NCT01014351|"~     Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin~     (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel~     with carboplatin should lead to improvements in efficacy as measured by progression-free~     survival and response rate.~   "
194747|NCT01014338|"~     A double blind randomised placebo controlled parallel trial of the effect of fosinopril, an~     angiotensin converting enzyme inhibitor, on the quadriceps muscle in 80 COPD patients who~     have quadriceps weakness. Patients will have a baseline assessment including measures of~     quadriceps strength and endurance and a quadriceps biopsy. Patients with weakness will be~     randomised to ACE inhibitor or placebo and re-assessed after three months of treatment.~      The investigators aim to show that ACE-inhibition will alter the IGF-1/AKT/FoXO/atrogene~     pathways involved in muscle wasting in COPD.~   "
194748|NCT01014325|"~     The objective of this clinical trial is to assess the safety and efficacy of sublingual~     application of allergen extracts for specific immunotherapy in patients suffering from~     perennial allergic rhinitis due to house dust mites.~   "
194749|NCT01014312|"~     This research study develop a collaborative depression care management model (C-DCM) that~     encourages collaboration between primary care physicians (PCPs) and trained social workers~     employed by community-based, public and nonprofit mental health clinics.~   "
194750|NCT01014299|"~     The purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver~     immediately after intubation in hypoxemic patients.~   "
194751|NCT01014286|"~     The primary objective of this protocol is to determine the frequency of oncogenic mutations~     in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational~     analyses will be used to determine the frequency of each mutation, its association with~     clinical features and outcome, and its association with other mutations. As future~     therapeutic protocols specific for these mutations are developed, patients may be notified of~     their eligibility for these studies. Future translational studies may be used to: a) unravel~     the complex biology of lung cancer; b) identify prognostic markers; c) define predictive~     markers of response/resistance to new therapies; d) identify new targets. A secondary goal is~     to establish a consortium of sites that have the capability of conducting multiple mutation~     testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.~   "
194752|NCT01014273|"~     This is a multi-national, multi-centre, randomized study comparing the trans-radial PCI~     access strategy and the trans-femoral PCI access strategy in ACS patients with UA or NSTEMI~     or STEMI planned to be treated with an invasive strategy (PCI).~      The hypothesis is that radial access site PCI will be associated with significantly less~     major bleeding and access site complications compared with a femoral approach, without~     increasing the risk of ischemic events. The overall benefit-risk profile will favor a~     trans-radial approach.~   "
194753|NCT01014260|"~     Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in~     SLE in developed countries. In a recent study the investigators have shown that high~     sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without)~     coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year~     intervention trial of atorvastatin, the investigators will determine if statins retard~     coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant~     of statins. The investigators want to now investigate whether there are additional, and~     potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will~     determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including~     interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell~     adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.~   "
194754|NCT01014247|"~     The aim of this study is to investigate the effect of moxifloxacin on the QT interval in~     order to gain information on the validity of results that will be collected during another~     clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1~     study).~   "
194755|NCT01014234|"~     The immune system response is mediated by the interaction between the antigen presenting cell~     (APC), CD4+ T helper cells (Th) and CD4+ CD25+ regulatory T cells, a subgroup of CD4+ T cell~     which express IL-2 receptor (CD25) and the transcriptional factor foxp3. Regulatory T cell~     may contribute to the maintenance of tolerance by suppressing the immune response to normal~     or tumor associated antigens.~      Regulatory T cell emerge from the thymus during ontogenesis and they represent about 10 % of~     the peripheral Cd4+ t cells.~      Rapamycin is one the most use treatment to prevent renal allograft failure. Differently from~     calcineurin inhibitors (cyclosporine and tacrolimus), that inhibit T-cell activation through~     the inhibition of calcineurin activation, rapamycin inhibits cellular proliferation by~     impairing the progression of the cellular cycle, in particular by interaction with mTOR.~     Recently Battaglia et al. have demonstrated a Treg amplification in murine CD4+ lymphocytes~     treated with rapamycin in vitro.~      Aim of the study is to evaluate the effect of different immunosuppressive regimens on~     regulatory T cell and to verify the hypothesis that rapamycin may induce tolerance in kidney~     transplanted patients, more than cyclosporine treatment.~   "
194756|NCT01014221|"~     To investigate the efficacy of acupuncture compared with steroid treatment in patients with~     mild-to-moderate carpal tunnel syndrome (CTS) as measured by objective changes in nerve~     conduction studies (NCS) and subjective symptoms assessment in a randomized, controlled~     study.~   "
194757|NCT01014208|"~     This study is being conducted to compare the efficacy and safety of ofatumumab in addition to~     salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive~     DLBCL subjects relapsing, or with persistent disease, after first-line treatment with~     rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.~   "
194758|NCT01014195|"~     1. This study will evaluate the association between changes in basic cognitive and~          behavioral functioning by the end of chemotherapy treatment, and the later development~          of higher order executive functions in pediatric acute lymphoblastic leukemia (ALL).~        2. The association between acute treatment-related changes in brain integrity and~          subsequent brain maturation in long-term survivors of pediatric ALL will be evaluated.~        3. The association between patterns of behavioral and executive dysfunction and brain~          maturation in long-term survivors of pediatric ALL will be examined.~        4. The association between genetic polymorphisms in key enzyme pathways and higher order~          brain development in long-term survivors of pediatric ALL will be explored.~        5. The associations between biologic and behavioral indices of fatigue/sleep and higher~          order brain development in long-term survivors of pediatric ALL will be explored.~   "
194759|NCT01014182|"~     Several recent trials (1,2) suggest that all STEMI patients receiving fibrinolysis in non-PCI~     centres should be routinely transferred for elective early PCI within 24 hours from~     hospitalization, with no additive risk of major bleeding complications or other severe~     adverse events compared standard therapy. These results in favour of a routine invasive~     strategy in STEMI patients suggest a potential change to the current approach of awaiting the~     response to treatment in patients receiving fibrinolysis, and draw the attention to the~     potential need for an appropriate network organization with adequate first hospitalization~     treatment (spoke) and prompt transfer to centres with 24/7 PCI capabilities (hub). The recent~     ESC (3) and ACC (4) guidelines on STEMI are consistent with the early ESC PCI Guidelines,~     recommending that angioplasty after fibrinolysis should be performed within a time-window~     ranging between 3 and 24 hours after successful lytic administration (level evidence IIA).~     The reason for the weighting of the recommendation is due to the heterogeneity of trial~     results with different planned-revascularization strategies, variable primary end-points~     definitions, and small individual trial sample sizes. Therefore, a consistent analysis of~     single patient dataset from all published randomized trials would be of value to better~     define the magnitude and duration of clinical benefit of the routine invasive strategy after~     lytic treatment as well as the potential optimal timing of such a strategy.~      The main aim of the OTTER meta-analysis is to define the benefits of immediate PCI after~     fibrinolysis for STEMI patients. Moreover, the OTTER meta-analysis will investigate the~     optimal timing of post-fibrinolysis elective revascularization.~   "
194760|NCT01014169|"~     The delivery of anticipatory guidance is an essential component of pediatric practice. Given~     the large amount of information to be shared during each encounter and the limited time~     available, there is a need for an effective and efficient means of communication between~     health care providers and families. The investigators hypothesize that more active parental~     participation in the form of note taking during the delivery of anticipatory guidance will~     lead to increased knowledge, higher levels of satisfaction with the encounter, and increased~     adoption of recommended parenting practices.~      In this study, the investigators propose a randomized controlled trial of the impact of note~     taking during the delivery of newborn anticipatory guidance on maternal practices related to~     newborn care. The investigators plan to compare a control group of mothers receiving standard~     of care anticipatory guidance with an intervention group of mothers who are encouraged to~     take written notes while receiving the anticipatory guidance. The primary outcome of interest~     is maternal practice related to infant sleep position, and the secondary outcomes of interest~     are maternal practice related to breastfeeding initiation and car seat use. The investigators~     also plan to evaluate the impact of note taking on mothers' knowledge of recommended~     practices related to newborn care and on mothers' satisfaction with the guidance received.~   "
194761|NCT01014156|"~     You are admitted to hospital because of pulmonary embolism. You are treated with~     anticoagulants.~      The investigators know that, despite this treatment, pulmonary embolism can be a threat~     especially if heart function is compromized.~      The investigators investigate a well known study drug (epoprostenol) on top of regular~     treatment with anticoagulants, to see if heart function can be optimized~   "
194762|NCT01014143|"~     Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and~     an oral rinse.~   "
194763|NCT01014130|"~     The purpose of this study is to investigate whether radiotherapy given as three large doses~     over a period of two weeks (hypofractionated radiotherapy) is more effective than standard~     radiotherapy for patients with non-small cell lung cancer that has not spread beyond the~     lung. Although surgery is the most effective treatment for early lung cancer, many patients~     are not fit enough for an operation. The alternative treatment to surgery is standard~     radiotherapy which is normally 'fractionated' that is, given as a number of small doses over~     a period of weeks. Experience has shown that many small treatments are safer than using a few~     large doses (hypofractionation) because there is less risk of damage to normal tissues.~      Recent advances in technology have however resulted in greater accuracy and with it a~     reduction in the amount of normal tissue affected by the radiation, so the risks of~     hypo-fractionation damaging normal tissue are of less concern. Initial results obtained with~     hypo-fractionated radiotherapy for early stage non-small cell lung cancer indicate that it~     may be more effective in controlling the cancer. However, it has never been compared directly~     with standard fractionation in a randomised trial, so this study aims to determine if~     hypo-fractionation is more effective, results in longer life expectancy and if it is just as~     safe as standard fractionation.~   "
194764|NCT01014117|"~     SRT2104 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic~     inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The~     objective of this study is to test if SRT2104 may be a novel compound for the treatment of~     inflammatory disorders in man.~   "
194765|NCT01014104|"~     This study is a prospective randomized clinical controlled trial to assess the efficacy of~     the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro~     fertilization (IVF) cycles.~   "
194766|NCT01014091|"~     The objective of this study is to evaluate the safety and immunogenicity study of GSK~     Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9~     years.~   "
194767|NCT01014078|"~     The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic~     solution, 1% in dry eye subjects over a four week treatment period, using placebo as a~     comparison.~   "
194768|NCT01014065|"~     While sunitinib can be very helpful to treat kidney cancer, these medications can also cause~     side effects, including heart damage. Studies performed in the past did not look at heart~     function in detail, so the investigators do not know what happens to the heart when people~     start sunitinib treatment. The aim of the study is to prospectively study acute effects of~     sunitinib on heart function, overall fitness and blood markers of heart disease.~   "
194769|NCT01014052|"~     The purpose of this study is:~        -  to evaluate the safety of oral QLT091001~        -  to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in~          subjects with LCA or RP due to RPE65 or LRAT mutations~        -  to evaluate duration of visual function improvement (if observed)~   "
194770|NCT01014039|"~     Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been~     implemented in many western countries. The estimated effect is based on case-control and~     observational studies. There are no randomized trials quantifying the effect of colonoscopy~     screening on CRC incidence and mortality.~      The present study investigates the effect of a population-based once-only colonoscopy~     screening with polypectomy on the incidence of CRC in an average risk population.~      In 1983, 900 individuals 55 to 64 years of age were randomly drawn from the population~     registry of Telemark county, Norway. 400 of these were invited to a flexible sigmoidoscopy~     screening examination, and 400 individuals were not offered any screening. In 1996, the~     remainder, both cohorts from 1983 were invited to a colonoscopy screening examination. A new~     age and sex matched control group, not being offered screening, was randomly drawn from the~     same registry. Both groups are to be followed with regard to CRC incidence, CRC mortality and~     all-cause mortality through national Norwegian registries.~   "
194771|NCT01014026|"~     Scientific Context~      High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer.~     Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's~     well-known that this test has significantly contributed to the reduction of mortality and~     morbidity due to cervical cancer. In France, it now seems that the screening strategy could~     be optimized. The two main ways are to reach the 7 million underscreened women (mass~     screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA~     testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA~     testing could be a relevant screening option: this technique appears reliable and it could~     allow to reach women who are never or seldom screened. Currently, there is no French data on~     the SCVS for HPV DNA testing.~      The goal of this study is to determine the performance and acceptability of a~     population-based strategy using self-collected vaginal samples for HPV DNA testing to reach~     women who are not participating in cervical cancer screening.~      Description of the project~      This project (APACHE-1) is a part of a project called APACHE. APACHE-1 will be dedicated to~     the SCVS technical validation and to the comparison between different transports medium. Nine~     hundred women will be recruited from the 20 to 65 years consultants in the Tours University~     Hospital (CHRU of Tours) and in the IRSA (health centre for routine medical checkup).~      Each woman will collect 2 SCVS with a nylon flocked swab (Copan® microRheologics™). The first~     SCVS will be put in a vial which contains a liquid medium. The second SCVS will be put in a~     dry vial. Then during the speculum examination the physician will collect a cervical sample~     with a Rovers® Cervex-Brush™ and then rinse it into a vial containing PréservCyt ™. A blind~     HPV DNA testing and genotyping (Inno-LIPA HPV Genotyping ™ Extra) will be performed in the~     virology laboratory of the CHRU of Tours on all samples (SCVSs and cervical samples performed~     by a physician). The performance of the SCVS to detect cervical HPV infection will be~     assessed (gold standard test = HPV DNA testing on cervical samples collected by the~     physician).~      In a second time (APACHE-2), the researchers will investigate to what extent offering home~     obtained SCVS leads to participation of unscreened women. APACHE-2 will be registered on~     Clinicaltrials as another project.~   "
194772|NCT01014013|"~     The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in~     treatment of complicated urinary tract infections with respect to the proportion of patients~     with a favorable microbiological response at 5-9 days post therapy.~   "
194773|NCT01014000|"~     Empirical implantation of the left ventricular lead is the prevailing practice in cardiac~     resynchronization therapy device implantation. The response rate to the therapy has been~     uniformly 70% only despite various methods to screen patients before device implantation.~     This study tested the hypothesis that echocardiography to assess acute resynchronization of~     the left ventricle during device implantation may improve the response rate to the therapy.~   "
194774|NCT01013987|"~     Phase 4, single arm, open label study designed to compare the safety and efficacy of~     antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and~     Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects.~      The purpose of this study is to look at the safety and efficacy of a combination of 3 new~     antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have~     multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48~     weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.~   "
194775|NCT01013974|"~     This is a single centre, randomized, double blind, placebo controlled, single and repeat dose~     study to investigate the safety, tolerability, and pharmacokinetics of inhaled dose of~     GSK573719 with lactose and containing magnesium stearate by a novel dry powder device in~     healthy Japanese male subjects.~   "
194776|NCT01013961|"~     RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer killing substances to them. Giving rituximab~     together with alemtuzumab may kill more cancer cells.~      PURPOSE: This randomized phase II trial is studying two different doses of rituximab to~     compare how well they work when given together with alemtuzumab in treating older patients~     with progressive chronic lymphocytic leukemia.~   "
194789|NCT01013792|"~     The primary objective is to:~        -  Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with~          PHI technology on wound healing in patients with a diabetic foot ulcer.~      Secondary objectives are to:~        -  Assess the adverse events that occur in subjects randomized to the investigational~          dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI~          technology.~        -  Assess the costs of using the investigational dressing compared to the Tegaderm Matrix~          Dressing with PHI technology.~        -  Assess and compare the impact that these dressings have on patients' quality of life.~        -  Assess the wound's biological response and pH to the study dressings.~   "
194790|NCT01013779|"~     A Phase II Study designed to evaluate the efficacy of Chemo-Radiotherapy in achieving~     loco-regional control in patients with Merkel Cell Carcinoma (MCC) of the skin. Patients will~     undergo PET scans to assist in staging and planning the patient's treatment as well as~     assessing response at the conclusion of treatment.~   "
194856|NCT01012908|"~     The primary objective of this clinical trial is to demonstrate non-inferiority clinical~     development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to~     pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of~     lipids in the feces of 72 hours after 14 days of treatment with each drug.~   "
194777|NCT01013948|"~     This is a cross-sectional study to determine the prevalence of symptomatic airway obstruction~     using the LFQ as a screening tool in primary care patients with a history of cigarette~     smoking and to provide descriptive data of this patient population. The study design is~     multicenter, cross-sectional, and involves a single visit. This study is not intended to~     evaluate the efficacy or safety of any investigational products. Following completion of~     written informed consent, eligible study subjects will complete a single study visit~     encompassing all required study assessments. Study subjects will not receive blinded study~     medication for evaluations of efficacy and safety.~      All eligible patients will complete a self-administered Web survey that will include the LFQ.~     To meet both the primary and secondary aims, all patients with LFQ ≤ 18 (current cut-off for~     obstruction), as well as 5% of patients who score > 18, will be candidates for spirometric~     assessment. Only this subset of patients will undergo pulmonary function tests. Albuterol~     will be self-administered for determination of post-bronchodilator forced expiratory volume~     in one-second (FEV1)/forced vital capacity (FVC) ratio and post-bronchodilator FEV1~     percentage of predicted normal. The study will end when 800 patients have been assessed~     spirometrically or 3,000 patients have completed the LFQ (whichever criterion is achieved~     first).~      Prior to implementation of the full study, a pilot study will be conducted at two of the~     chosen study sites to pretest the proposed study procedures.~   "
194778|NCT01013935|"~     The purpose of this study is to see if a computer counseling tool helps Spanish-speaking~     people living with HIV to have safer sex and to do well on their HIV medicines.~   "
194779|NCT01013922|"~     The purpose of this study is to explore if certain characteristics, easily detected within a~     regular primary care setting, may indicate that a patient at risk for COPD (45 ≤ age ≤ 80~     years and a smoking history of ≥ 15 pack years) is prone to have a diagnosis of COPD~     according to Medical Products Agency guidelines.~   "
194780|NCT01013909|"~     The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable~     efficacy to a Terbinafine solution applied once.~   "
194781|NCT01013896|"~     The investigators research group and others have found that patient-reported adherence to all~     aspects of the regimen is suboptimal and objective measures suggest even poorer adherence.~     There is little data, however that identifies and examines the reason for nonadherence in an~     adult Cystic Fibrosis (CF) population or identifies effective strategies for improving~     adherence.~      The investigators propose to evaluate the relative efficacy of a Motivational~     Interviewing-focused intervention (MI) in improving adherence and reducing CF-related~     morbidity compared to a CF education intervention (CFE; attention control group).~     Specifically, The investigators hypothesize that MI will result in improved regimen adherence~     and reduced CF morbidity compared to the CFE control group.~   "
194782|NCT01013883|"~     Having heart failure means the heart is unable to pump blood around the body effectively.~     This reduces life expectancy and hinders normal daily activities. Heart failure affects about~     one million people in the UK; it is a major cause of death but it is often undetected and~     under-treated. If diagnosed and treated properly, the symptoms of heart failure can be well~     controlled and the length and quality of life can be improved.~      Two drugs (called ACE-inhibitors and beta-blockers) help patients to live longer and suffer~     fewer consequences of heart failure. These drugs should be offered to all patients although~     this does not happen consistently for a variety of reasons. Doctors specialising in heart~     failure may help patients make better informed decisions about treatments and other aspects~     of care.~      The purpose of this research is to explore the diagnosis, management and outcome of patients~     with heart failure who are referred to the one stop diagnostic heart failure clinic between~     Jan 2002 and Dec 2007. This study will provide vital information about diagnosis, initiation~     and titration of evidence based medication in the hospital, their follow in the primary care~     and subsequent patient outcome in terms of mortality.~   "
194783|NCT01013870|"~     The purpose of this study is to improve the ability to diagnose problems after mild traumatic~     brain injury (MTBI) and to test a drug that may improve the outcome from these injuries. Of~     the more than 1.5 million people who experience a traumatic brain injury (TBI) each year in~     the United States, as many as 75% sustain a mild TBI which can cause long-term or permanent~     impairments/disabilities in a significant proportion of patients. In addition, traumatic~     brain injury has become a signature injury of the wars in Iraq and Afghanistan. For people~     with these injuries, it is difficult to determine whether symptoms are due to the head injury~     or another condition, such as Post-traumatic Stress Disorder. In this project, there are 3~     observational studies that involve testing of mental functions and behavior, imaging of the~     brain with special x-ray procedures, and blood samples to look at glandular function, which~     may be affected by head injury. A fourth study is a test of a drug, atorvastatin, which may~     provide protection for injured brain cells and improve outcome. By collecting and analyzing~     the information from these tests, it will be possible to make the process of diagnosing mild~     TBI or post traumatic stress disorder (PTSD) more precise, and also to see if atorvastatin is~     a helpful drug for patients with MTBI.~   "
194784|NCT01013857|"~     Patients with poorly controlled hypertension will have improved hypertensive control with~     telephone coaching and with telephone coaching combined with home-titration of medications.~   "
194785|NCT01013844|"~     This study is a behavioral science study designed to identify aspects of the dyadic~     relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing~     melanoma. The patient is randomized to receive the educational intervention either as a solo~     learner or with the partner.~   "
194786|NCT01013831|"~     This phase I trial studies the side effects and best dose of erlotinib hydrochloride in~     preventing cancer in patients with precancerous lesions of the lung. Erlotinib hydrochloride~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
194787|NCT01013818|"~     The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients~     with relapsed or refractory lymphoid malignancies.~   "
194788|NCT01013805|"~     The aims of the trial are (1) to determine the tolerability rate in the setting of a~     multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and~     complete pathologic response rate in patients with locally advanced rectal cancer who are~     treated with an integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.~   "
194791|NCT01013766|"~     This study is the second administration of GSK1362885 in humans. GSK1362885 is a novel,~     potent inhibitor of human glycogen phosphorylase (GP) under development for the treatment of~     type 2 diabetes mellitus (T2DM). This study will investigate the compound's safety,~     tolerability, pharmacokinetics, and pharmacodynamics in subjects with Type 2 Diabetes~     Mellitus.~   "
194792|NCT01013753|"~     The primary objective of this study is to determine the efficacy and safety of 4 doses of BI~     1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in~     patients with asthma in comparison to placebo.~   "
194793|NCT01013740|"~     This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the~     efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women~     with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one~     chemotherapeutic regimen in the metastatic setting.~   "
194794|NCT01013727|"~     To study in two cross-sections of healthy volunteers, with single photon emission computed~     tomography (SPECT), the possible changes generated in the mid-term by two rehabilitation~     techniques: the postural reconstruction and the muscular stretching. The changes in the~     cortical activation patterns will be estimated during a non-specific position of the ankle,~     held static.~      The influence of each technique will be estimated though the evidence of a change in the~     functional mapping of the areas activated during the defined motor task on healthy~     volunteers.~   "
194795|NCT01013714|"~     The purpose of this research study is to examine the effect of cardiac sympathetic~     denervation (CSD) surgery on life threatening abnormal heart rhythms called ventricular~     tachycardia or ventricular fibrillation that can lead to sudden cardiac death. Subjects will~     be asked to participate in this research study if they have recurrent ventricular tachycardia~     (at least one ICD shock for ventricular tachycardia) and have undergone at least one catheter~     ablation procedure or have ventricular tachycardia or fibrillation that is not ablatable. The~     goal of this study is to determine whether cardiac sympathetic denervation can prevent these~     abnormal heart rhythms from occurring and therefore, prevent, ICD shocks which are not only~     painful, but have been shown to reduce quality of life and/or lead to depression,~     particularly in the period immediately after the shock.~   "
194796|NCT01013701|"~     Fluticasone furoate is being studied to determine whether treatment with a topical nasal~     steroid, in patients with existing nasal polyps , can not only improve symptoms but also~     suppress the recurrence of clinically significant nasal polyp obstruction and prevent~     surgical intervention.~   "
194797|NCT01013688|"~     The purpose of this study is to determine whether concomitant radiofrequency Maze procedure~     for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could~     provide better sinus rhythm control, improved cardiac hemodynamic status and decreased~     thromboembolism events and to compare if biatrial is better than left atrial procedure? 150~     rheumatic valve patients with chronic atrial fibrillation (AF) having concomitant valve~     surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation~     group, and Amiodarone group. All patients were scheduled followed up before discharge and at~     3rd, 6th and 12th postoperative months. Standard 12-lead electrocardiography (ECG), 24-hour~     Holter and transthoracic echocardiography were used to determine the rhythm and cardiac~     hemodynamic status.~   "
194798|NCT01013675|"~     A controlled, double-blind study to determine the immunogenicity and safety of influenza cell~     derived vaccine in elderly subjects.~   "
194799|NCT01013662|"~     Study of the lipid metabolism under glycemic control in septic patients who got an university~     14 bed ICU.~      Hypothesis: establish a relationship between lipid metabolism alterations and glycemic~     control or infusion of exogenous insulin~   "
194800|NCT01013649|"~     This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without~     erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation~     therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was~     removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride,~     capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor~     cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation~     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known~     whether chemotherapy is more effective when given with or without erlotinib hydrochloride~     and/or radiation therapy in treating pancreatic cancer.~   "
194801|NCT01013636|"~     Anaplasmosis is a tick-borne transmitted infection. Its clinical expression include fever,~     cytopenia and hepatitis.This infection was initially described in United States. In Europe,~     its epidemiology is not well known. Some isolated cases have been diagnosed in several~     country, were the tick Ixodes ricinus is known to transmitted another infection :the Lyme~     borreliosis.The purpose of our study is to look systematically for Anaplasmosis, in patient~     living in Eastern France, and presenting with compatible clinical symptoms using a new~     diagnosis tool : PCR in blood samples. So we will have new data about epidemiology in our~     country and the clinical symptoms that are associated with Anaplasmosis.~   "
194802|NCT01013623|"~     This study will establish the role of surgical versus nonsurgical approaches in patients~     whose melanoma has spread to distant sites. Results will help clinicians develop a~     standardized initial approach that prolongs survival and optimizes quality of life. Results~     also will indicate whether Bacillus Calmette-Guerin (BCG) postoperative immunotherapy~     significantly improves the outcome of patients treated with surgery.~   "
194803|NCT01013610|"~     To evaluate the safety, tolerability, multiple dose plasma pharmacokinetics (PK) of LNK-754~     in male and female elderly volunteers after dosing with LNK-754 for 7 days and in subjects~     with mild Alzheimer's Disease after dosing with LNK-754 for 28 days.~   "
194804|NCT01013597|"~     The purpose of this study is to evaluate the tumor response rate in patients with metastatic~     medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC)~     after receiving treatment with LBH589 20 mg by mouth, three times weekly. Time to~     progression, overall survival, toxicity, tolerability, and Notch1 protein expression patterns~     will also be evaluated.~   "
194805|NCT01013584|"~     Vitamin D3 is a vitamin that is an essential component of biological regulating systems in~     humans. Sun exposure is the predominant source of vitamin D3. Previous research has shown~     that vitamin D3 deficiency is common worldwide. It is especially common in northern countries~     with long winters due to inadequate sun exposure during winter. In the US, an estimated 36%~     to 57% of healthy middle-aged to elderly adults have vitamin D3 deficiency. Current research~     indicates that obesity is associated with a low vitamin D3 level.~   "
194806|NCT01013571|"~     Primary Objective:~      The primary objective of this study is to demonstrate non-inferiority of a patient-managed~     titration algorithm (including blood glucose monitoring) for the addition of a single dose of~     insulin glulisine at breakfast in Canadian patients with inadequately controlled T2DM after~     optimization of basal insulin, compared with an HCP-managed titration algorithm. The primary~     endpoint for assessment of this objective is the percent of patients reaching a target HbA1c~     <=7.0% without severe hypoglycemia at the end of the study.~      Secondary Objective:~      Secondary objectives of the study are to compare the effect of the two different insulin~     glulisine titration algorithms (patient-managed versus HCP-managed) on the following:~        -  change in HbA1c, FG, and 7-point glucose profile at Week 24 and Week 36~        -  satisfaction with treatment (DTSQc for patient and questionnaire for HCP) at Week 36~        -  change in weight at Week 24 and Week 36~        -  incidence of hypoglycemia~        -  insulin doses~        -  resource utilization (rural/urban, blood glucose meter test strips, lancets, HCP visits,~          telephone calls, and hospitalizations)~        -  adherence with the patient-managed monitoring algorithm~   "
194807|NCT01013558|"~     The concept of fetal pain is becoming increasingly relevant due to growing possibilities for~     invasive intrauterine treatment. There is much debate as to whether the fetus is mature~     enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at~     least capable of exhibiting a stress response to intrauterine needling. Intrauterine~     transfusions are most commonly performed by inserting a needle either in the umbilical cord~     root at the placental surface, or in the intrahepatic portion of the umbilical vein of the~     fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in~     alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These~     changes were not observed in intrauterine needling in the umbilical cord root, or after~     administration of analgesics to the fetus. The investigators tested the hypothesis that~     remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The~     investigators performed a randomised controlled trial comparing fetal stress response between~     patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving~     remifentanil, or placebo.~   "
194808|NCT01013545|"~     This study will contrast two experimental treatment conditions by testing whether joint~     attention/joint engagement intervention using spoken communication (JAE-EMT) results in~     better outcomes than joint attention/joint engagement intervention that is instead~     supplemented with an individualized AAC system (JAE-AAC). Thus, the skills of joint~     attention/joint engagement (JAE) remain foundational to developing expressive language but~     the difference in the two treatments will be between whether the JAE is administered through~     the more traditional spoken means (EMT) or through an augmentative and alternative~     communication device (AAC).~   "
194809|NCT01013532|"~     Through this study, the investigators are to prove that Cilostazol effectively prevent~     cardiovascular events in ischemic stroke patients with high risk of cerebral hemorrhage,~     along with no significant increase in the risk of occurrence of hemorrhagic side effects.~      The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the~     risk of cerebral hemorrhage without increase of cardiovascular events compared to aspirin in~     the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.~      This study will prove the superiority of cilostazol on the prevention of cerebral hemorrhagic~     events without increasing the cardiovascular events against aspirin and the superiority of~     probucol on the prevention of overall cardiovascular events.~   "
194810|NCT01013506|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole +/- goserelin (the latter for pre-menopausal women only) may fight breast cancer by~     lowering the amount of estrogen the body makes. OSI-906 and erlotinib hydrochloride may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not~     yet known whether hormone therapy and OSI-906 are more effective when given with or without~     erlotinib hydrochloride in treating hormone-sensitive metastatic breast cancer.~      PURPOSE: This phase II trial is studying how well giving hormone therapy together with~     OSI-906 with or without erlotinib hydrochloride works in treating hormone-sensitive patients~     with metastatic breast cancer.~   "
194811|NCT01013493|"~     Myopia is the main reason of vision loss in the world which is seen in 30.4 million adults in~     USA (1). In a myopic eye, images are focused in front of retina because, cornea and~     crystalline lens become more powerful in focusing the image or the eye axis become too long~     (axial myopia) (2).~      Myopia prevalence in adolescents has been raised in recent years and nowadays it has reached~     to 10-25% and 60-80% in western and eastern countries respectively (3). Tehran eye study~     showed that the prevalence of myopia in Tehran is 21.8% and 17.2% based on manifest and~     cycloplegic refraction respectively (4). One study in Dezful, Iran showed that 3.7% of 7-15~     years old children are myopic (5).~      Today potential role of early life nutrition in myopia development in later life is becoming~     an attractive field of study. It has been shown that until weaning; breast milk is the main~     source of many nutrients [such as docosahexaenoic acid (DHA)] which are important for~     photoreceptors and cortical neuronal development (6). But results about the relationship~     between breastfeeding and likelihood of childhood myopia are controversial. A~     hypothesis-generating study (7) showed an independent and inverse relationship between~     breastfeeding and likelihood of myopia in 10-12 year old Singaporean children. However, data~     pulled from three English birth cohorts done in 10-11y and 15-16y children did not show any~     effect (8).~      To examine the association between breastfeeding pattern and likelihood of myopia in 6-7y~     children, a retrospective case-control study is designed in National Nutrition and Food~     Technology research Institute of Iran. This study will try to assess breastfeeding pattern~     and almost all cofactors which may relate to myopia.~   "
194826|NCT01013298|"~     The purpose of this study is to determine the feasibility, safety and effectiveness of an~     endotracheal tube embedded with a mini video-camera as a guiding tool for percutaneous~     tracheostomy.~   "
194812|NCT01013480|"~     Study 22001, A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy,~     Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile~     X Syndrome currently is evaluating the efficacy of STX209 (R-baclofen) for management of~     typical problem behaviors, such as irritability and aggression, in subjects with FXS. This~     study (22002) will enter subjects who complete Study 22001 into a long-term, open-label~     study.The open-label extension protocol will provide necessary data on the long-term safety~     and tolerability of STX209 among subjects with FXS who receive treatment under conditions~     more closely reflective of their general medical care.~   "
194813|NCT01013467|"~     Insufficient blood pressure control is a frequent problem despite the existence of effective~     treatment. One of the causes is insufficient self-monitoring and a lack of adherence to~     therapy. Blood pressure self-measurement at home (Home Blood Pressure Measurement, HBPM) has~     positive effects on treatment adherence and is helpful in achieving the target blood~     pressure.~      Only a few studies have investigated whether the adherence for HBPM can be improved through~     simple measures and better blood pressure monitoring can be achieved.~      Objective Improvement of self-monitoring by means of blood pressure self-measurement and~     improved blood pressure control by using a new colour-coded blood pressure diary~   "
194814|NCT01013454|"~     This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a~     varenicline patch applied to the skin.~   "
194815|NCT01013441|"~     The purpose of this research study is to test whether giving T-cells (type of white blood~     cell that are also known as immune cells) that have been specially processed in the~     laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system return to~     normal faster after chemotherapy. This research study will also look into the ability of the~     lab to process the T-cells for infusion and the side effects of giving T-cells to patients~     with chronic lymphocytic leukemia (CLL).~   "
194816|NCT01013428|"~     To prospectively assess the healing process following suture of profound fexor tendon due to~     traumatic rupture of FDP-Tendon in Zone II by ultrasound.~   "
194817|NCT01013415|"~     The purpose of this study is to find out the safety and activity of an experimental anti-HIV~     treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant~     interleukin2). The treatments that the investigators are studying try to improve the immune~     system by changing some of your T cells so they can find and destroy HIV infected cells (HIV~     is usually able to hide from your T cells). In this study, the investigators are also trying~     to find out if giving you more IL-2 at the same time as gene changed T cells will help the T~     cells to live longer or fight HIV better.~   "
194818|NCT01013402|"~     The purpose of this study is to compare the accuracies and the capillary and venous~     comparabilities of five different home glucose monitors; Optium Xceed, Contour Ts, Accu-chek~     Go, One Touch Select and Ez Smart in an adult population.~   "
194819|NCT01013389|"~     The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX~     and INFUSE in achieving bone fusion.~      The secondary objective of this clinical trial is to assess clinical outcome measurements.~   "
194820|NCT01013376|"~     The safety and comfort of repeated administrations of a topically-administered ophthalmic~     formulation of MC-1101 will be established through investigator assessments and subject~     reporting over a 3 day period. Safety assessments will be performed on both normal, healthy~     subjects as well as those with the signs and symptoms of early non-exudative age-related~     macular degeneration (dry AMD).~   "
194821|NCT01013363|"~     Most first trimester abortions are performed under local anesthesia using either manual or~     electric vacuum suction aspiration. The majority of women undergoing these procedures~     experience some amount of pain and anxiety. The investigators seek to understand if the~     provision of music during first trimester abortion will reduce pain and anxiety associated~     with this procedure. This study will involve the use of music during first trimester abortion~     as an additional method of pain and anxiety control. The investigators will recruit women~     seeking a first trimester suction aspiration procedure primarily for elective pregnancy~     termination or for other related indications such as an abnormal pregnancy, inevitable~     abortion, or retained products of conception. Participation will be voluntary and include~     informed consent. Recruited women will be divided into two groups: control group (no music)~     and intervention (music) group. All subjects will receive routine care and standard pain~     control measures, including local anesthesia, during their procedure. Those assigned to the~     intervention group will receive a portable digital music player (iPOD™ Nano) with headphones~     to listen to during their procedure. All subjects will complete preoperative and~     postoperative pain and anxiety questionnaires in addition to a patient satisfaction survey at~     the end of their visit. The provider will also assess and record the subject's pain~     experienced during the procedure. The investigators will also measure preoperative and~     postoperative vital signs on all participants. Subjects will be compensated for their time~     and study participation will not affect any care received at the clinic. Upon completion of~     their visit, there will be no additional followup for this study.~   "
194822|NCT01013350|"~     Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients who Have~     Participated in Cladribine Clinical Trials~   "
194823|NCT01013337|"~     RATIONALE: Acupuncture may help relieve moderate or severe joint pain caused by aromatase~     inhibitors.~      PURPOSE: This randomized phase II trial is studying acupuncture in treating women with stage~     I, stage II, or stage III breast cancer with aromatase inhibitor-related joint pain.~   "
194824|NCT01013324|"~     There has not been any systemic therapy approved in the United States or in Europe for~     treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety~     and preliminary efficacy of XL147 in advanced or recurrent EC.~      Constitutively active phosphatidylinositol-3 kinase (PI3K)/phosphatase and tensin homolog on~     chromosome 10 (PTEN) pathway signaling is common in EC and involved in the development and/or~     progression of the disease. PTEN deficiency and/or activating mutations/amplification in the~     PIK3CA gene that encodes the p110α catalytic subunit of PI3K have been frequently detected in~     EC patients. XL147 is a potent and highly selective inhibitor of the Class I PI3K family of~     lipid kinases. In addition, in vivo preclinical data have demonstrated that XL147 targets~     both proximal and distal signaling in the PI3K/PTEN pathway. Therefore, XL147 may have~     utility in the treatment of subjects with advanced or recurrent EC.~   "
194825|NCT01013311|"~     The purpose of this study is to identify patients with cardiac sarcoidosis who may be at risk~     for sudden death.~   "
194827|NCT01013285|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such~     as temozolomide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to~     kill tumor cells. Giving bevacizumab together with temozolomide and radiation therapy may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab~     together with temozolomide and external beam radiation therapy works when given as first-line~     therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.~   "
194828|NCT01013272|"~     Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no~     previous other antiviral treatment) will be invited to participate in this study. They will~     be eligible if their liver tests are normal and their viral load is undetectable. Patients~     will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate~     suppression of the hepatitis B virus after successful treatment with entecavir. Patients will~     be monitored closely after switching treatment at 1 months and then every 3 monthly. If there~     is any evidence of increase in viral load then patients will be given the option of changing~     back to entecavir.~   "
194829|NCT01013259|"~     Due to the worldwide increasing prevalence of the allergic rhinoconjunctivitis, new~     therapeutical strategies are needed. The symptomatic treatment with topical and systemic~     antihistamines and corticosteroids are often insufficient. E.coli Nissle 1917 has~     immunomodulatory capacities and reveals less side effects. E.coli Nissle 1917 has no sedative~     properties and exhibits no hepatotoxic qualities. Thus, E.coli Nissle 1917 represents a new~     relevant therapeutical agent.~   "
194830|NCT01013246|"~     The aim of this study is to examine the effects of playing video games on various components~     of energy balance and substrate metabolism as well as on glucose homeostasis and relevant~     hormonal systems that might be involved in the underlying mechanisms.~   "
194831|NCT01013233|"~     The purpose of this study is to improve cognitive dysfunction following chemotherapy, the~     investigators investigated to see whether a cognitive training for memory and concentration~     skills can improve cognitive performance in patients following cancer treatment.~   "
194832|NCT01013220|"~     Randomized trials demonstrate that depression management products can improve clinical and~     organizational outcomes sufficiently for selected employers to realize a return on~     investment. Rather than usual care marketing which uses voltage-enhanced promises to sell~     voltage-diminished products, the investigators designed an evidence-based (EB) intervention~     to encourage employers to purchase a depression management product that offers the type,~     intensity and duration of care shown to provide clinical and organizational value. In an RCT~     designed to examine employer benefit purchasing behavior of depression products in 360~     employer members of over 20 regional business coalitions, the research team proposes: (a) to~     compare the impact of evidence-based (EB) to usual care (UC) presentations on employer~     benefit purchasing behavior, and (b) to identify mediators and organizational moderators of~     intervention impact on employer benefit purchasing behavior.~      This study addresses what policy analysts argue is one of the most pivotal problems in the~     translation of evidence-based care to 'real world' settings: whether purchasers can be~     influenced to buy health care products on the basis of value rather than cost. In the likely~     event that EB > UC, the study will provide encouragement to use an evidence-based approach to~     market new health care products to private payers on the basis of the product's clinical and~     organizational value. UC may achieve comparable outcomes to EB if the limiting factors in~     benefit purchasing are organizational, purchasing group and vendor constraints that no~     intervention can meaningfully modify. Support for this scenario would encourage the targeted~     marketing of new products to coalition members with empirically identified organizational,~     purchasing group and vendor characteristics, using usual care strategies.~   "
194833|NCT01013207|"~     Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the~     upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway~     Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway~     pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy~     to improve the comfort of the delivered air and to alleviate nasal dryness/congestion.~      The latest design of a CPAP device, known as Nexus (S9), encompasses new features including~     an improved humidification system (heated tube and climate control), reduced noise, improved~     comfort of breathing, and a new user interface.~      This study will assess whether compliance on CPAP therapy is improved on the Nexus (S9) CPAP,~     and will assess the usability of the Nexus (S9) CPAP~   "
194834|NCT01013194|"~     The herein study consists in the transplantation of liver progenitor cells isolated from~     human fetal liver tissue with the aim of improving conventional liver therapy and broadening~     therapeutical options other than liver transplantation.~   "
194835|NCT01013181|"~     The purpose of this study is to review the charts of the first 100 patients included in the~     french compassionate program including patients with Immune Thrombopenia receiving~     romiplostim.~   "
194836|NCT01013168|"~     The purpose of this study is to collect further data for safety and feasibility for the use~     of the medical device OncoSorb® in clinical routine for the treatment of patients with solid~     metastatic cancer entities who have failed standard therapies. OncoSorb® device is intended~     to specifically adsorb three soluble receptors (sTNF-R1, sTNF-R2 and sIL-2R α), which are~     known to inhibit the natural immune response of cancer patients mediated via tumor necrosis~     factor α (TNF- α).~   "
194837|NCT01013155|"~     The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg~     tablet under fed conditions~   "
194838|NCT01013142|"~     The objective of this clinical study is to determine the safety of intravenous MN-221~     compared to placebo when administered in subjects diagnosed with stable moderate to severe~     COPD.~   "
194839|NCT01013129|"~     RATIONALE: Gathering information about genetic and environmental factors may help doctors~     learn more about a person's risk for developing prostate cancer.~      PURPOSE: This clinical trial is studying genes, environment, and prostate cancer risk in~     patients with or without prostate cancer and their first-degree relatives.~   "
194841|NCT01013103|"~     The present study constitutes a study examining the effect of atorvastatin on vascular~     function in high cardiovascular risk patients. For this purpose the investigators will record~     atorvastatin effects on statin-naïve patients (patients that start statins treatment for~     first time). More specifically the investigators will study atorvastatin effects on:~        1. Endothelial function~        2. Arterial elastic properties~        3. Systemic Inflammatory/thrombotic mechanisms~        4. Vascular and myocardial redox state~   "
194842|NCT01013090|"~     Hypotension resulted from neuraxial block is a common problem, of which is a special issue in~     patients undergoing Cesarean section. A large number of studies and clinical guidelines~     suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing~     hypotension. However, it is still a controversy because the fact of a relatively increased~     blood volume in parturients. In addition, although it is effective of fluid management, it's~     precise relationship between fluid (crystalloid or colloid) volume and the proportion of~     hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The~     investigators designed this trial to clarify the accurate relationship between fluid volume~     in an escalated manner and the occurrence of hypotension analyzed with a non-linear~     regression, and wanted to present the 50% effective volume (EV50) of fluid including~     crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.~   "
194843|NCT01013077|"~     The purpose of this study is to investigate how the addition of a new emulsion artificial~     tear to the tear layer of dry eye and normal patients affects aberrometry, contrast~     sensitivity, and reading ability over time. Previous studies have indicated that daily use of~     artificial tears over a two week period decreases the short term affect of drop application~     on aberrometry and contrast sensitivity measurements. The present study will examine the~     effects of 4 weeks of artificial tear use to determine when the responses stabilize.~   "
194844|NCT01013064|"~     Study design:~        -  Randomized, double-blind, placebo-controlled, sequential dose escalation~        -  Six ascending dose cohorts are planned~      Primary Objective:~        -  To evaluate the safety profile of single escalating intravenous dose levels of HM10760A~   "
194845|NCT01013051|"~     Background: Gastric bypass is the most commonly performed type of bariatric (obesity)~     surgery, has dramatically increased in popularity and is now considered to be preferred~     treatments in severely obese patients that fail non-surgical therapy - particularly in~     patients with type 2 diabetes. Drug malabsorption is a potential concern post-gastric bypass~     because intestinal length is reduced.~      Purpose: The purpose of this controlled, pharmacokinetic study is to determine whether the~     absorption of a single dose of metformin, the first line drug treatment in patients with type~     2 diabetes, is significantly reduced after gastric bypass.~      Methods: A single dose of standard release metformin 1000 mg will be administered to patients~     who have undergone gastric bypass and to patients who have not received surgery but are on~     the wait list (wait-listed controls). Blood sampling and urine sampling will occur in~     standardized fashion over the ensuing 24 hours to measure and compare the absorption of~     metformin between study arms. 34 patients total will be recruited.~      Significance: Following completion of this study, we will better understand how gastric~     bypass affects metformin absorption. Ultimately, this information will help to ensure that~     this patient population is receiving optimal doses of this important drug treatment.~   "
194846|NCT01013038|"~     In this trial, the investigators will evaluate the effect of thrombus aspiration followed by~     stent implantation in improving myocardial blush grade in patients with acute~     non-ST-elevation myocardial infarction compared to conventional percutaneous coronary~     intervention (PCI).~   "
194847|NCT01013025|"~     The main study objective was to collect implant retrieval information in 10 patients using~     Vantas®, the 50 mg histrelin implant. Patients who had been identified as having a difficult~     to locate or non-palpable implant were to have been enrolled. Sites were to adhere to the~     instructions in the Package Insert, which included specialized investigations such as~     ultrasound, CT, and MRI, to be used for the location and removal of implants.~   "
194848|NCT01013012|"~     The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for~     preventing postoperative nausea and vomiting in highly susceptible patients following spine~     surgery.~   "
194849|NCT01012999|"~     The purpose of this study is to determine the appropriate dose and effectiveness of~     intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to~     severe pain due to broken bone(s) in the arm or leg.~   "
194850|NCT01012986|"~     Theme: The reading of fixed texts in school are widely known, however it is not known how~     they read texts furniture and what skills are required for this type of reading.~      Objective: To evaluate the skills of reading film subtitles in students of 2nd and 4th grade~     of elementary school of a Public School.~      Method: Review the level and skills of reading movies subtitles (RMS), through the recounting~     of a section of film watched, alone, mute and legend, for 60 students (30 2nd grade and 30 of~     the 4th grade) matched for age and gender.~   "
194851|NCT01012973|"~     To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into~     the eye on vision function in subjects with macular edema as a consequence of central retinal~     vein occlusion~   "
194852|NCT01012960|"~     The purpose of this study is to evaluate if opioid-induced effects on the pharynx and~     esophagus is centrally or peripherally mediated.~   "
194853|NCT01012947|"~     This study was based on baseline data derived from a large prospective study called the Suwon~     Project (SP), a cohort comprising random clustering samples of elderly people, all of whom~     are ethnic Koreans aged over 60 years.~   "
194854|NCT01012934|"~     The objective of this study is to investigate the bioequivalence of Mylan's alendronate~     sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70~     mg) dose administration under fasting conditions.~   "
194855|NCT01012921|"~     The aim of the study is to test in a randomized comparative study the performance of~     Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared~     to that of a standard collagen membrane (BioGide®) in the bone regeneration around Straumann®~     SLActive bone level titanium implants.~      Furthermore the clinical evaluation and comparison of complementary parameters describing the~     bony and soft tissue environments at the surgical sites during the study period to evaluate~     effectiveness and performance of the membranes.~   "
194859|NCT01012869|"~     Chronically total occlusions (CTO) are difficult to treat and have high risk for restenosis.~     Although everolimus-eluting stents (EES) [(Xience, Abbott Vascular) or Promus (Boston~     Scientific)] are very promising for the treatment of CTOs due to their low late loss and~     excellent deliverability, there are currently no published data on EES implantation in CTOs.~      The specific aim of this proposal is to examine the 8-month incidence of binary angiographic~     in-stent restenosis (defined as a stenosis of > 50% of the minimum lumen diameter of the~     target stent) after implantation of the EES in CTO.~      It is the investigators hypothesis that EES-treated CTO lesions will have ≤ 20% 8-month~     in-stent binary angiographic restenosis rate.~   "
194860|NCT01012856|"~     The purpose of this study is to investigate, if exposure-based cognitive therapy (EBCT) is at~     least as effective as the established cognitive-behavioral therapy and more effective in its~     long-term efficacy. Moreover the mechanisms of change of the EBCT are investigated.~   "
194861|NCT01012843|"~     Purpose: This randomized study assesses the effects of antibiotics on the formation of~     fistulae after drainage of anorectal abscesses.~      Methods: Patients who underwent abscess drainage in 3 major colorectal units between~     September 2005 and January 2008 were included. Previous anorectal surgery history,~     immunecompromised states, pregnancy, inflammatory bowel disease, antibiotic usage prior to~     surgery and the presence of an anal fistulae at the time of surgery were the exclusion~     criteria. Patients were randomized and given either placebo or amoxicillin-clavulanic acid~     combination treatment for 10 days. Patients were followed one year for perianal fistulae~     formation.~   "
194862|NCT01012830|"~     Use Huperzine-A, a herbal supplement normally used for treatment of Alzheimer's disease, to~     potentially improve cognitive dysfunction (memory problems) and functional capacity (ability~     to perform common daily tasks such as cooking, bathing, telephone, shopping) in people with~     schizophrenia.~   "
194863|NCT01012817|"~     This phase I/II trial studies the side effects and best dose of veliparib and topotecan~     hydrochloride and to see how well they work in treating patients with solid tumors, ovarian~     cancer that has come back or does not respond to treatment, or primary peritoneal cancer.~     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving veliparib with chemotherapy may kill~     more tumor cells.~   "
194864|NCT01012804|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is looking at biomarkers in tissue samples from patients with~     metastatic colon cancer.~   "
194865|NCT01012791|"~     The main purpose of this study is to compare the effects on attention and memory functioning~     to participating in an aerobic and dance exercise called Zumba to educational program on~     exercise that encourages regular stretching and walking.~   "
194866|NCT01012778|"~     A multimodal intervention was rolled out at a large public school in Najibabad, Uttar Pradesh~     (UP). The program identified elementary school children with ADHD and Dyslexia using standard~     screening of all children who had performance impairment in at least one domain of the~     Vanderbilt questionnaire. The program consisted of play therapy, physical exercise, yoga and~     meditation. The program was established by High school volunteers from The US and UK over 6~     weeks. Once implemented during the morning of school, high school volunteers from the school~     were trained to continue the program. Vanderbilt questionnaires were completed at intervals~     to allow follow up.~   "
194867|NCT01012765|"~     This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on~     inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as~     comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In~     particular, spirometric timepoints are included to elucidate the peak-IC in a period of~     approximately 4 hour post inhalation~   "
194868|NCT01012752|"~     This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific~     immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.~   "
194869|NCT01012739|"~     This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different~     formulations of indacaterol, one administered via the Concept1 device and one administered~     via the Simoon device. The study aimed to determine whether the novel formulation (Simoon)~     had a similar profile to that of the established formulation (Concept1).~   "
194870|NCT01012726|"~     The investigators will study whether local instillation of Doxycycline and Acetylcystein~     results in fistula closure in CD patients.~   "
194871|NCT01012713|"~     This is a 12-week, open-label, pilot trial evaluating the efficacy and safety of the~     combination of Clobex® spray with excimer laser therapy as the initial treatment of~     generalized plaque psoriasis, followed by maintenance therapy with topical Vectical. The~     study will be conducted in three distinct periods, namely Period A, Period B, and Period C,~     each of 4 weeks duration. During Period A (weeks 1 through 4), patients will use Clobex®~     spray twice daily along with excimer laser treatments twice weekly with the Photomedex XTRAC®~     Velocity machine. The goal of Period A is to achieve Psoriasis Area Severity Index (PASI) 75~     in 100% of patients within four weeks. During Period B (weeks 5 through 8), patients would be~     treated with topical Vectical® twice daily. Thus, there is a steroid-free interval during~     which patients will not be using Clobex® spray. The goal of Period B is to maintain the~     patient's response using only non-steroid options. During Period C of the study, patients~     will use Clobex® spray BID and Vectical® BID. Period C (weeks 9 through 12) will be a~     booster period in which the goal is to see if 100% of patients can achieve Psoriasis Area~     Severity Index (PASI) 90-100. Regarding excimer laser therapy: all patients will be receiving~     excimer laser therapy twice weekly for the first 6 weeks of the study (up to the halfway~     point) which is 12 excimer laser treatments. At that point, only those patients achieving~     <Psoriasis Area Severity Index (PASI)75 response will continue to receive twice weekly~     excimer laser treatments for the remaining 6 weeks of the study.~   "
195034|NCT01010581|"~     The purpose of the study is to determine the efficacy, safety and pharmacokinetics of SC12267~     (4SC-101, 35 mg) in combination with methotrexate in comparison to methotrexate alone in the~     treatment of patients suffering from Rheumatoid Arthritis.~   "
194872|NCT01012700|"~     Vaccines induce protective immunity against numerous infectious diseases. However, current~     vaccines have limited efficacy against challenging infections like tuberculosis, malaria and~     HIV. Protein vaccines are safe but, typically, they induce weak T cell immunity when~     administered alone. Therefore, special attention is being given to adjuvants, which are~     enhancers of immunity, that mature antigen presenting immunostimulatory dendritic cells~     (DCs). Our goal is to study in humans the mechanism whereby synthetic adjuvants, acting on~     defined pattern recognition receptors (PRR), enhance T and B cell immunity. In preclinical~     studies, the investigators' laboratory has found in mice that poly IC and its analog poly~     ICLC are superior adjuvants for T cell mediated immunity relative to other agonists for PRR.~     In this study the investigators propose to study the safety and the innate immune responses~     to poly ICLC in multiple blood cell types, including three different subsets of DCs when~     administered subcutaneously or intranasally to healthy volunteers. Poly ICLC is a stabilized~     double stranded RNA which has been extensively studied in humans with a favorable safety~     profile.~   "
194873|NCT01012687|"~     The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg~     tablets under fasting conditions.~   "
194874|NCT01012674|"~     The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering~     from carotid or vertebral arterial disease.~   "
194875|NCT01012661|"~     To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler~     mixed with lidocaine.~   "
194876|NCT01012648|"~     RCT colloids versus cristalloids only in severe burn victims.~        -  Trial with medicinal product~   "
194877|NCT01012635|"~     This study compares five different procedures to see how they affect pain and brain activity.~     The procedures include neurofeedback, self-hypnosis training, meditation, and two different~     levels of transcranial direct current stimulation (tDCS). Subjects will be compensated for~     their time.~   "
194878|NCT01012622|"~     The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral~     System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder~     (ADHD).~   "
194879|NCT01012609|"~     Standard treatment for patients with diffuse pontine tumors is radiation therapy, but less~     than 10% of patients are cured. Adding standard chemotherapy has not improved the cure rate.~      Standard treatment for high-grade astrocytomas is surgery and radiation. The surgeon removes~     as much of the tumor as she or he can. Radiation after that tries to kill any cancer cells~     that are left. Some patients also get chemotherapy. These are anti-cancer drugs. They can be~     given during or after radiation. Current standard treatments do not cure many patients.~      In this study the doctors are adding a new medication called cetuximab to the treatment and~     will also use a chemotherapy medication (irinotecan) that has been promising for patients~     treated for recurrent disease.~   "
194880|NCT01012596|"~     The Creighton Model (CrM) FertilityCare System is a natural family planning method that~     teaches couples to recognize and chart the signs of fertility and infertility in the woman's~     cycle and to use that knowledge to either achieve or avoid a pregnancy. The method is~     natural, safe and effective, and it helps the couple understand their fertility. Trained~     practitioners at FertilityCare Centers teach the Creighton Model across the country,~     internationally and long distance.~      Several FertilityCare Centers and the University of Utah are conducting a study to evaluate~     the effectiveness of the Creighton Model (CrM) for new and return users wanting to avoid~     pregnancy. While past studies have shown that the Creighton Model is a highly effective~     method, this study will use new ways to measure how well it works. This is important because~     the knowledge gained will improve comparisons between the Creighton Model and other family~     planning methods. The study will also explore intentions and behaviors of couples to avoid or~     achieve a pregnancy.~      The investigators hypothesize that for the CrM the pregnancy rate during perfect use to avoid~     pregnancy will be about 1% and the behaviorally determined avoiding-related pregnancy rate~     for the CrM will be about 6%. The investigators will also evaluate the pregnancy rate during~     typical use without a previously stated intention to conceive (in CrM terms, a mixture of~     avoiding and achieving-related behavior).~   "
194881|NCT01012583|"~     BACKGROUND Treatment of coronary atherosclerotic disease has been significantly advanced by~     interventional cardiology, and the advent of coronary arterial stents. In comparison to~     angioplasty alone, stents have reduced the incidence of angiographic as well as clinical~     restenosis, the recurrence of angina, the need for coronary arterial bypass graft (CABG)~     surgery, repeat revascularization and the occurrence of major adverse cardiac events~     (MACE).However the long-term success of this therapy has been limited by the occurrence of~     in-stent restenosis. Despite the effectiveness of intracoronary stents in maintaining a~     larger luminal diameter, as compared to angioplasty alone, in-stent restenosis occurs within~     6 to 9 months after stent placement in 15% to 35% of patients. While stents can reduce~     restenosis by blocking vascular recoil and remodeling, mechanical intervention alone has been~     incapable of treating this biological problem of neointimal hyperplasia, particularly in the~     subset of patients with diabetes, long lesions or small vessel disease.Drug-eluting stents~     (DES) were developed as a viable method for focused delivery of anti-restenosis compounds to~     target lesions for the reduction of restenosis. Of the DES available and with the results of~     up to six (6) years clinical follow-up, the sirolimus-eluting stent (SES) has become the~     current gold standard for stent implantation. With the advent of using DES to treat complex~     lesions such as longer lesions requiring the use of multiple stents and the use in~     bifurcation lesions, the risk of stent thrombosis has increase.Late stent thrombosis has also~     been reported following DES implantation.Long term treatment with dual anti-platelet therapy~     following stent implantation has become the solution used to counteract the risk of stent~     thrombosis, this solution does not come without it's own risks and is an expensive therapy.~     Another specific problem of DES is delayed endothelization, and this may be and attributing~     factor in prolonging the period of thrombotic risk as shown by pathological findings at~     autopsy following SES implantation. These examinations have shown that even after 16 months,~     neointimal healing is still incomplete with approximately 20% of stent struts being found~     uncovered. Questions have arose that the problems of late thrombosis and delayed~     endothelization of stent struts with DES could be the result of the permanent polymer that is~     used as the bonding agent for the anti-restenosis compounds to the stents.Intravascular~     Ultrasound (IVUS) along with angiography has been the techniques used to gain data on DES to~     this point. Angiography is a 2 dimensional tool that gives a view of the vessel and IVUS~     gives a more 3 dimensional view of the vessel. IVUS does have its limitations, as stent~     struts are reflectors of sonic waves, shadowing around and behind the struts occurs. IVUS is~     also limited in detecting malapposition of the struts to the vessel wall especially if the~     area between the vessel wall and the strut in very small.~      RATIONALE Optical Coherence Tomography (OCT) is an optical analogue of IVUS that uses an~     infrared light source and measures the backscatter of the light. With this technique a higher~     level of resolution compared with IVUS has been reported.OCT has been reported as being able~     to visualize and detect atherosclerotic plaques and assess more accurately strut~     malapposition and the presence or thickness of neointimal hyperplasia as compared to IVUS.~     With the question of delayed endothelization due to the permanent polymer being a probable~     risk for late stent thrombosis, it is felt that OCT post stent implantation may give a more~     accurate assessment of stent strut endothelial coverage.~      This study is designed to compare the intimal hyperplasia following implantation of the Excel~     DES with a biodegradable polymer vs. the Cypher DES with a permanent polymer using OCT.~   "
194882|NCT01012570|"~     The investigators will study the effect of Adalimumab on the bone microstructure.~        -  Trial with medicinal product~   "
194883|NCT01012557|"~     Pregnant women are at particular risk during the imminent H1N1v influenza pandemic. The new~     H1N1v virus requires urgent political and medical decisions on vaccination strategies in~     order to minimize severe disease and death from this pandemic. However, there is a lack of~     evidence to build such decisions upon. A vaccine will be provided in the fourth quarter of~     2009, but there is little knowledge on the immunogenicity. Particularly its clinical~     effectiveness and duration of immunity in pregnant women and their newborn infants is~     unknown. Therefore, it will be important to study the optimal vaccination regimens with~     respect to dosing and use of adjuvant to decide future health policies on vaccination of~     pregnant women. We have a unique possibility to study these aspects of H1N1v infection in~     pregnant women in our ongoing unselected, prospective, birth-cohort study recruiting 800~     pregnant mothers between Q1- 2009 and Q4-2010. Pregnant women from East-Denmark are being~     enrolled during the 2nd trimester and their infant will undergo a close clinical follow-up.~     The H1N1v pandemic is expected to reach Denmark Q4-2009. The timing of this enrollment and~     the imminent pandemic allows for an experiment of nature whereby the first half of the~     mothers completes pregnancy before the H1N1v pandemic. The other half of this cohort will be~     pregnant while H1N1v is prevalent in the community and will require H1N1v vaccination. The~     aim of this randomized, controlled, trial is to compare and evaluate the dose-related immune~     protection conferred by vaccine and adjuvant (Novartis vaccine Focetria) in pregnant women~     and non-pregnant women. In addition the protocol will assess the passive immunity conferred~     to the newborn from these vaccine regimes. The study will provide evidence-based guidance for~     health policies on vaccination for the population of pregnant women during future H1N1v~     pandemics.~   "
194884|NCT01012544|"~     Recent studies have demonstrated a marked interindividual variability of clopidogrel's~     capacity to inhibit platelet aggregation with a substantial proportion (11-34%) of the~     patients considered non-responders to clopidogrel treatment. Variable intestinal absorption~     is suggested to contribute to the inconsistencies in response to clopidogrel. However, little~     is known about intestinal absorption in subjects who had suffered from a stent thrombosis.~     The MAPCAT-study has been designed to investigate whether plasma pharmacokinetics~     (represented by Cmax, Tmax and the AUC) after a 600 mg loading dose are significantly~     different between subjects who have suffered a stent thrombosis and subjects who have not~     suffered a stent thrombosis.~   "
194885|NCT01012531|"~     The objective of this study is to assess the efficacy and safety of cluster immunotherapy~     with highly polymerized allergen extracts.~   "
194886|NCT01012518|"~     The purpose of this study is to compare the feasibility, safety, efficacy and ease of~     performance of a video-assisted PCT (via an endotracheal tube embedded with a mini~     video-camera) with the standard (blind) PCT technique.~   "
194887|NCT01012505|"~     Mammalian fetal sensory development comes in an invariant series, with the~     tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to~     stimulation, implicating the importance of these foundational sensory systems for later~     development. Olfaction is essential for neonatal behavioral adaptation in many mammals,~     including humans. Experiments show that newborns recognize, and are soothed by, the smell of~     amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn,~     breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste~     input can facilitate recognition by the infant's mother at a later time and does not appear~     to be detrimental to the stability of the infant.~      Provision of the odor and taste of the mother's milk has been shown to facilitate the~     infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation~     for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will~     provide quantitive analysis to the effect of smell.~   "
194888|NCT01012492|"~     The primary objective of the study is to determine the safety and tolerability when adding~     abatacept to acute Graft versus Host Disease in transplants for malignant diseases using~     unrelated donor bone marrow or peripheral blood stem cell grafts.~   "
194889|NCT01012479|"~     The purpose of this study is to see if Candesartan, once daily (QD), added with~     Hydrochlorothiazide may be helpful in treating people with newly diagnosed severe essential~     hypertension.~   "
194890|NCT01012466|"~     The purpose of this study is to find out if negative thoughts have an effect on pain~     experienced during labor and how labor progresses. Other studies have shown that women who~     experience intense pain in the earliest stages of labor have a higher risk of complications.~     The investigators want to know if negative thoughts can predict this outcome.~   "
194891|NCT01012453|"~     Objectives and perspective:~        1. To estimate the prevalence of hand eczema in a cohort of health care workers and assess~          exposures in the hospital environment that can lead to hand eczema . To investigate the~          knowledge of skin protection among health care workers.~        2. To classify subtypes of hand eczema, assess severity of hand eczema and quality of life~          in health care workers with hand eczema~        3. To evaluate the effect of a combination of classification of hand eczema and individual~          work-related counseling in skin protective behavior.~      The overall perspective of the trial is to develop new strategies for prevention of~     occupational hand eczema in health care workers.~      Hypotheses:~        -  Irritant contact dermatitis is more common than allergic contact dermatitis.~        -  The combination of precise classification (subtyping of HE) and individual counseling~          will have a positive impact on the prognosis of hand eczema.~        -  The positive impact on the prognosis of hand eczema will have a positive impact on~          quality of life (QoL).~        -  The knowledge of protective behavior will increase.~        -  Education in a skin care program will have a positive impact on skin protective~          behavior.~   "
194892|NCT01012440|"~     The purpose of this study is:~        1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to~          neoadjuvant chemotherapy in patients with breast cancer?~        2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care~          bilateral breast MRI.~   "
194893|NCT01012427|"~     This study is being done to test how effective cryoablation is in killing cancer cells.~     Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating~     freezing temperatures within a needle probe. When this probe is inserted into a cancer, the~     freezing temperatures are used to try and kill the cancer. Unfortunately, the investigators~     don't know how well cryoablation works at destroying the cancer. This study will allow us to~     check to see how well cryoablation works for kidney cancers. After the investigators destroy~     the kidney cancers using cryoablation, the investigators will followup with you every 5-7~     months to make sure the cryoablation worked and that the cancer was destroyed.~   "
194894|NCT01012414|"~     The purpose of this study is to determine if vitamin D supplementation changes the results of~     certain tests associated with inflammation in the body using an oral, synthetic form of~     vitamin D called paricalcitol.~   "
194895|NCT01012401|"~     This study will examine the potential for an Interactive Cancer Communication System (ICCS)~     to impact not only psychosocial outcomes such as quality of life but also length of survival~     in an advanced stage lung cancer population. Two hypotheses will be tested: the Comprehensive~     Health Enhancement Support System- Lung Cancer (CHESS- LC) will significantly improve patient~     quality of life and length of overall survival as compared to a usual care control group.~   "
194896|NCT01012388|"~     Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and~     hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving~     nasolabial fold treatment with Radiesse® Injectable Dermal Filler~   "
194897|NCT01012375|"~     The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared~     to placebo improves ADHD symptoms and is well tolerated.~   "
194898|NCT01012362|"~     This is a Phase I study; dose escalating the combination of pazopanib when taken daily and~     ixabepilone when administered on day 1 of a 3 week treatment course.~   "
194899|NCT01012349|"~     This study aims is to evaluate, two hours after a single administration, the rate of~     sustained response produced by the association Geolab consisting of acetylsalicylic acid,~     sodium bicarbonate and anhydrous citric acid - oral powder, with the active comparator~     acetylsalicylic acid (Aspirin ® -- Bayer) - a simple tablet for the treatment of acute pain~     in patients with mild to moderate CTTE, using for both the visual analog scale pain - VAS.~   "
194900|NCT01012336|"~     The current recommended guideline for patients receiving moderately emetogenic chemotherapy~     (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of~     chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving~     MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been~     observed. Hence, there is clearly a need for more effective prevention of CINV in patients~     receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to~     these symptoms. Therefore the investigators designed a study with the objective to evaluate~     if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in~     ovarian carcinoma patients treated with taxane/carboplatin.~   "
194902|NCT01012310|"~     The purpose of this study is to determine the safety and toleration of single and multiple~     doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083~     and its metabolites, following single and multiple dose administration in healthy male and/or~     female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in~     metabolism of other drugs following multiple dosing).~   "
194903|NCT01012297|"~     This randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and~     bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and~     a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used~     in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether~     gemcitabine hydrochloride and docetaxel are more effective when given with or without~     bevacizumab in treating uterine leiomyosarcoma.~   "
194904|NCT01012284|"~     The purpose of this study is to assess the pharmacokinetics (what the body does to the~     medication), safety and tolerability of TMC207 and its N-monodesmethyl metabolite (M2) in~     healthy participants and in patients with moderate hepatic impairment after administration of~     a single 400 mg dose of TMC207.~   "
194905|NCT01012271|"~     The purpose of our study is to evaluate the diagnostic accuracy of MR arthrography of the~     wrist at 1.5, 3.0, and 7.0T with wrist arthroscopy as reference standard.~   "
194906|NCT01012258|"~     Primary objective: to assess the antitumor activity and safety profile of cetuximab when~     given in combination with radiotherapy (RT) for the treatment of locally advanced squamous~     cell carcinoma of the head and neck (SCCHN) in Chinese subjects.~      Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of~     cetuximab in Chinese subjects.~      Further objective: to identify for cetuximab potential predictive biomarkers of response and~     safety.~   "
194907|NCT01012245|"~     Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom~     in Germany and to assess the long-term efficacy and tolerability under routine conditions.~     Data were entered into an electronic case report form.~   "
194908|NCT01012232|"~     In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee~     arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus~     injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high~     concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at~     rest and with mobilization for 2 hours after injections.~   "
194909|NCT01012219|"~     This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of~     laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in~     combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3~     will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and~     laropiprant components of Tredaptive.~   "
194910|NCT01012206|"~     The aim is to investigate the development of overweight and obesity from infancy to school~     age, and to evaluate an intervention to prevent further development of overweight and obesity~     among children.~      A follow-up study will be conducted on 267 children and will allow comparison between~     children that developed overweight with the ones who did not. Subjects will be requited at 10~     years of age from a previous project. These children have been studied when they were 6-18~     months old and a follow-up was conducted at 4 years of age. Sixteen percent of the children~     were overweight at 4 years of age and retrospective data of e.g. food intake, blood lipids~     and anthropometric measurements exists. In the present follow-up data regarding food and~     physical activity habits, anthropometric measurements and blood samples of e.g. blood lipids,~     IGF1 will be collected.~      An intervention study will be conducted on 80-120 overweight children that will be randomized~     into one intervention and one control group. An intervention during two years will encourage~     long term healthy habits regarding diet and physical activity through group meetings and~     supervision. Information about food habits will be collected through questionnaires,~     interviews and diaries. Measurement of physical activity and energy expenditure will be made~     with Sense Wear and double labeled water, and will be used to validate reported food intake.~     Further, anthropometric measurements and blood samples will be collected.~   "
194911|NCT01012193|"~     The purpose of this study is to determine the impact of adjunctive cilostazol versus high~     maintenance-dose clopidogrel on platelet inhibition in carriers and non-carriers of the~     loss-of-function CYP2C19 mutant allele.~   "
194912|NCT01012180|"~     Background:~        -  Bipolar disorder is a common mood disorder that affects 1% to 2% of the population.~          Individuals with bipolar disorder tend to have periods of mania that are characterized~          by extra energy, very poor judgment or unrealistic beliefs about their thoughts and~          abilities, and an inability to complete thoughts and tasks; as well as major depressive~          episodes. The range and frequency of symptoms in affected individuals can vary greatly.~          Most individuals have cyclical symptoms and spend more time in a normal mood state than~          in an overtly symptomatic state.~        -  Relatives of individuals with bipolar disorder have an increased risk for bipolar~          disorder and other mood disorders. Currently, risk assessment for recurrence of a mood~          disorder is based on family and medical histories; genetic testing has not proved~          particularly useful to date for assessing risks of a mood disorder.~        -  Despite its prevalence, there is limited research on coping with bipolar illness. No~          published studies have examined adaptation to living with bipolar disorder or risk for~          bipolar disorder. More specifically, though a positive family history is the most~          important known risk factor for bipolar disorder, there are no published studies about~          response to the threat of future illness onset in children, risk modification efforts~          undertaken by affected parents, or coping with the risk for illness in children.~      Objectives:~        -  To examine parents appraisals of the impact and cause of bipolar disorder, and the~          association with their perceived risk for bipolar illness in their child and how they~          cope with their perception of risk to their child.~        -  To assess whether parents adaptation to their own illness is associated with coping with~          perceived risk to their child.~        -  To describe parents coping strategies related to perceived risk in their children.~      Eligibility:~      - Men and women at least 18 years of age who have been diagnosed with bipolar disorder and~     who have at least one biological child (30 years of age or younger). Participants must be a~     primary caregiver for their children.~      Design:~        -  Participants in this study will take an online survey and answer questions about disease~          perceptions, coping strategies, and adapting to a diagnosis of bipolar disorder,~          addressing issues such as the following:~        -  Assessing the threat of bipolar disorder and coping with one s own illness.~        -  Optimism/pessimism of the individual coping with the illness.~        -  Perception of risk to a child, and coping with the perceived risk.~        -  Data from this study will not be shared with the participants/respondents.~   "
195035|NCT01010568|"~     The purpose of this study is to evaluate the safety and effectiveness of the combination of~     bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia~     and small cell lymphoma. All subjects enrolled on this study will receive both drugs by~     intravenous (IV) infusion.~   "
194913|NCT01012167|"~     The project is designed to address the following two primary aims:~        1. To determine whether adjunctive oxytocin is superior to placebo for the treatment of~          persistent negative symptoms, as measured by the SANS total score, in people with~          schizophrenia.~        2. To determine whether adjunctive Galantamine is superior to placebo for the treatment of~          cognitive impairments, as measured by improvement on a composite neurocognitive score in~          people with schizophrenia.~      The investigators will also address the following secondary aims:~        1. To determine whether people with schizophrenia treated with adjunctive oxytocin,~          compared to placebo, will show greater improvement on markers of negative symptom~          liability including: social affiliation, facial affect recognition, olfactory~          discrimination, initiation of smooth pursuit and latency of internally-driven saccades.~        2. To determine whether people with schizophrenia treated with adjunctive Galantamine,~          compared to placebo, will show greater improvement on markers of cognitive impairment~          liability including: predictive pursuit, P50 sensory gating and visual-spatial working~          memory.~      The investigators will address the following exploratory aims:~        1. To determine whether changes in markers of negative symptom liability are correlated~          with changes in SANS total score.~        2. To determine whether changes in markers of cognitive impairment liability are correlated~          with changes in the composite neurocognitive score.~        3. To determine the response to oxytocin of all cognition domains assessed by the MATRICS~          battery, and to determine the response to Galantamine of all cognition domains assessed~          by the MATRICS, which are not included in the primary neurocognitive outcome score.~        4. To determine whether there is a differential response of oxytocin and Galantamine on the~          SANS total score, composite neurocognitive score, and with the phenotypic measures of~          negative symptom and cognitive impairment liability.~        5. To determine whether oxytocin and Galantamine are associated with:~             -  adverse effects on positive or depressive symptoms;~             -  adverse effects on motor symptoms;~             -  adverse effects on laboratory and EKG measures;~             -  increased occurrence of side effects;~             -  social interest that is independent of sexual desire.~   "
194914|NCT01012154|"~     This study aims to create an atlas based on the preliminary experience of the first~     feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used~     during neurosurgery to provide in vivo histology that enables documentation of neurological~     pathology across a range of tumor ypes and grades, suitable for comparison with traditional~     histopathology from site‐matched biopsies.~   "
194915|NCT01012141|"~     RATIONALE : Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary~     supplements, such as phytochemicals, may stop or delay the development of prostate cancer.~   "
194916|NCT01012128|"~     Preterm infants will have their body temperature measured by three different devices in order~     to evaluate whether the newest device, a temporal artery scanning thermometer, is accurate~     for patients in the preterm period.~   "
194917|NCT01012115|"~     In an effort to better understand the interaction between the different mediators, the~     investigators propose to examine the time course of mediators, the indexes of organ injury~     and the coagulation cascade.~   "
194918|NCT01012102|"~     To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with~     Montanide® ISA 51 VG with regard to immunological efficacy.~      The primary target variable is the immune response as assessed by ELISPOT before and until~     week 17 after vaccination with EMD 640744 in Montanide® ISA 51 VG.~   "
194919|NCT01012089|"~     The purpose of this study is to:~        1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and~          peritoneal dialysis (PD).~        2. Determine urine, HD and PD clearance of daptomycin.~   "
194920|NCT01012076|"~     Eighty parent-child dyads will be recruited and randomly assigned to either the experimental~     intervention or an active control condition. Subjects assigned to the experimental group will~     participate in 12 home-based intervention sessions.~   "
194921|NCT01012063|"~     The object of this study is to evaluate whether low dose intravenous iron and erythropoietin~     (Epo) can decrease transfusion requirement after the bilateral TKRA.~   "
194922|NCT01012050|"~     Despite the physiologic and clinical effects provided by coupling nebulization with~     noninvasive ventilation in asthma exacerbation, there are few and controversial studies~     reported in the literature.~   "
194923|NCT01012037|"~     The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg~     twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as~     add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient~     glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily~     compared to 5 mg once daily and each treatment's superiority over placebo.~   "
194924|NCT01012011|"~     This surveillance are to identify problems/questions regarding adverse events, factors that~     are considered to affect on safety and efficacy in the clinical practice of using Nexavar~   "
194925|NCT01011998|"~     The aim of this study is to test the effect of the combination of valproate in combination~     with imatinib with an aim of achieving a maximal molecular response as the primary goal.~   "
194926|NCT01011985|"~     To determine if the type of hemodialysis vascular access correlates with markers of~     inflammation, namely C-reactive protein and interleukin-6, and with both access and patient~     survival in the end stage renal disease population.~   "
194927|NCT01011972|"~     XMT-1107 has been shown in nonclinical studies to slow the growth of tumors. These effects~     may result from blocking the growth of new blood vessels that help the tumors survive.~   "
194928|NCT01011959|"~     This is a randomized study of the safety and tolerability of multiple doses of REGN88 in~     rheumatoid arthritis patients who are receiving treatment with methotrexate.~   "
194929|NCT01011946|"~     The purpose of this study is to determine if PEM scan can improve axillary lymph node staging~     by assessing if they are involved by cancer. Your doctor may refer you for a PEM scan, PEM~     stands for positron emission mammography, a relatively new and advanced application of~     positron emission tomography or PET scanning. For decades, PET has helped doctors diagnose~     and treat disease.~   "
194930|NCT01011933|"~     This phase II trial is studying how well selumetinib works in treating patients with~     recurrent or persistent endometrial cancer that has come back or is persistent. Selumetinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
194952|NCT01011647|"~     A novel technique in identifying unspecified sleep apnea has been developed. This technique~     uses signals typical acquired from a bedside monitor that is found in critical care~     environments. Those signals are then processed by a sleep analysis algorithm to provide an~     Apnoea Hypopnea Index (AHI) score. This study is intended to determine whether the prevalence~     of sleep disordered breathing identification among patients in a Coronary Care Unit (CCU)~     using this novel approach is significantly different than using routine techniques.~   "
194953|NCT01011634|"~     In the United States, the majority of first-trimester surgical abortions are performed in~     outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain~     control. The specific aim of this study is to evaluate the equivalency of intravenous~     moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis~     (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg) for~     first-trimester surgical abortions. The investigators hypothesize that oral moderate sedation~     and intravenous moderate sedation will be equivalent in controlling pain as measured by a~     difference of +/- 10 on a 100-point (range 0-100) visual analog pain scale.~   "
194931|NCT01011920|"~     This is a multicenter open label randomized phase II trial.~      Enrolled Primary Central Nervous System Lymphoma (PCNSL) patients will be stratified~     according to the IELSG score and randomized to receive one of the follows as primary~     chemotherapy:~        -  Arm A: Methotrexate (MTX) + Cytarabine (Ara-C)~        -  Arm B: MTX + Ara-C + rituximab~        -  Arm C: MTX + Ara-C + rituximab + thiotepa.~      Chemotherapy will be administered every three weeks. The maximum number of chemotherapy~     induction courses will be 4. Patients in Stable Disease (SD) or better after two courses will~     receive two more courses of the same primary chemotherapy regimen. Stem-cells harvest will be~     performed in the three arms after the second course. After 4 courses response assessment will~     be performed.~      Patients who will not achieve SD or better after the 4th course, as well as those who will~     experience Progressive Disease (PD) at any time and those who will not achieve a sufficient~     stem cell harvest, will receive Whole Brain Radiation Therapy (WBRT) 36-40 Gy +/- tumor bed~     boost of 9 Gy.~      Patients who will achieve SD or better after the 4th course will be stratified according to~     objective response to primary chemotherapy and to primary chemotherapy regimen and randomly~     allocated to receive as consolidation therapy one of the follows:~        -  Arm D: WBRT 36 Gy +/- boost 9 Gy~        -  Arm E: Carmustine (BCNU) + Thiotepa + Autologous Peripheral Blood Stem Cell Transplant~          (APBSCT) Patients in Complete Response (CR) after WBRT or APBSCT will remain in~          follow-up. Patients who will not achieve a CR after WBRT will be managed according to~          physician's preferences. Patients who will not achieve a CR after APBSCT will be~          referred to WBRT.~   "
194932|NCT01011907|"~     Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which~     either varenicline (twice daily) or placebo will be administered over a 12 week study period~     to examine genetic influences on treatment response to varenicline for reduction of hazardous~     drinking.~   "
194933|NCT01011894|"~     The purpose of this study is to:~      Determine the likelihood that lenalidomide will adequately control the disease for at least~     one year.~      Lenalidomide is a drug that alters the immune system and it may also interfere with the~     development of tiny blood vessels that help support tumor growth. Therefore, in theory, it~     may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and~     Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome~     (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have~     received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being~     tested in a variety of cancer conditions.~      In this case it is considered experimental. The lenalidomide being administered in this study~     is not a commercially marketed product. Although it is expected to be very similar in safety~     and activity to the commercially marketed drug, it is possible that some differences may~     exist. Because this is not a commercially marketed drug, lenalidomide can only be~     administered to patients enrolled in this clinical trial and may only be administered under~     the direction of physicians who are investigators in this clinical trial.~   "
194934|NCT01011881|"~     The purpose of this study is to determine pleural level of procalcitonin in differents~     situations of pleuritis.~   "
194935|NCT01011868|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in~     combination with basal insulin in patients with type 2 diabetes mellitus with insufficient~     glycaemic control.~   "
194936|NCT01011855|"~     The purpose of this study is to compare three radiant warmer beds that contain different~     computer heating software and different bed styles. Radiant warmers are used in many neonatal~     intensive care units (NICU) to provide heat to infants to help regulate an infant's~     temperature. It is common for babies to require care on an open bed that provides heat to the~     baby according to the baby's needs and at the same time allows easy access to the baby for~     care and necessary procedures. There are different styles of beds, each with unique computer~     software that can guide how a bed's heater output is automatically adjusted according to a~     baby's temperature needs. It is unknown which style of bed or method of heating might be~     best. This study seeks to evaluate infant responses to three different types of radiant~     warmer beds.~   "
194937|NCT01011842|"~     To determine if a new optical system that can track a patient's movement during treatment can~     be used to measure motion and allow for motion adjustments in order to decrease the amount of~     healthy tissue that receives radiation without limiting our ability to cure cancers using~     radiation.~   "
194938|NCT01011829|"~     Methamphetamine (MA) abuse is the fastest growing drug problem in the United States and is~     responsible for significant public health complications, including HIV infection. As a result~     effective treatments for MA dependence are urgently needed. There are currently no~     efficacious medications for MA dependence, although results from preliminary randomized~     trials of bupropion for MA dependence found bupropion to be more effective than placebo, but~     only among subgroups of participants, including those with lower frequency of MA use at~     baseline. A growing body of preclinical and clinical studies suggest that cholinergic~     mechanisms play an important role in the neurobiology of MA and other stimulant dependence,~     such as nicotine dependence. Mechanistically, cholinergic medications may alleviate~     MA-associated cognitive dysfunction, thereby improving outcomes of treatment for MA~     dependence. Varenicline is a partial agonist at α4β2 nicotinic receptors and a full agonist~     at α7 nicotinic receptors that has been approved as an anti-cigarette smoking medication. In~     order to assess the potential efficacy of varenicline for methamphetamine dependence, we will~     perform a clinical trial to assess if varenicline compared to placebo results in greater:~        1. reductions in methamphetamine use;~        2. treatment retention;~   "
194939|NCT01011816|"~     The purpose of this investigation is to establish the safety and efficacy of the Biostat~     System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal~     disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group~     receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another~     group receiving a preservative-free normal saline control delivered with the Biostat Delivery~     Device.~   "
194978|NCT01011309|"~     The purpose of this study is to determine the efficacy, safety, and immunogenicity of an~     investigational vaccine being developed for the treatment of leishmaniasis, including~     cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a~     Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.~   "
194940|NCT01011803|"~     Swallowing implies the appropriate use and sufficient function of specific muscles that are~     also used in speech. Theoretically, if these muscles are functionally affected then phonation~     and vocalization should be impaired, as well. The purpose of this study is to examine the~     relationship between functions of speech and risk of aspiration as defined by swallowing~     function, and to investigate the diagnostic potential that functions of speech may have in~     predicting the risk of aspiration. This could allow for earlier stratification of ICU~     patients for aspiration risks. Aspiration pneumonia has been reported in more than 20% of~     patients with health care-associated pneumonia. There are multiple tools to assess for risk~     of aspiration in the ICU, yet these are time consuming, often delayed and involve advanced~     testing that is performed by a certified speech-language pathologist and/or radiologist. A~     novel 3-step phonetic evaluation was created and will be implemented on ICU patients at risk~     for aspiration, and the results will be correlated to the standard swallowing tests. If~     strong correlation is found in this pilot study, then formal clinical trial will follow to~     confirm that the simple bed-side phonetic evaluation could allow for earlier identification~     of patients at risk for aspiration, and more efficient management relative to time and~     resources utilization.~   "
194941|NCT01011790|"~     The purpose of this study is to assess a novel meditation program which is biofeedback~     reinforced (Healing Rhythms™) as a means to improving stress management in a population of~     nurses practicing in the hospital setting.~   "
194942|NCT01011777|"~     The aim of this study is to study safety, tolerability and efficacy of muscle derived cell~     (MDC) therapy in children with bladder exstrophy epispadias induced urinary incontinence.~   "
194943|NCT01011764|"~     The goal of this study is to compare the effects of two separate, manualized group~     interventions designed to improve social outcomes for young children with autism. The first~     type of group intervention utilizes a social skill curriculum delivered to a small group of~     children with autism at their school. This type of group will be referred to as the Skills~     group (SKILLS intervention). The other intervention delivers a social engagement curriculum~     at the children's school site and includes children with autism and typically developing~     peers, from the same school. This type of group will be referred to as the School Engagement~     Group (ENGAGE intervention).~   "
194944|NCT01011751|"~     The purpose of this study is to compare the efficacy of three drugs (cyproterone acetate,~     medroxyprogesterone acetate and venlafaxine) in the treatment of hot flushes caused by~     leuprorelin LP 11.25 milligram (mg) in participants suffering from prostate cancer.~   "
194945|NCT01011738|"~     This observational, non-interventional cohort study will evaluate predictors of response in~     patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and~     safety parameters will also be evaluated. Patients included in the study will be followed for~     the duration of their treatment and for up to 3 years thereafter.~   "
194946|NCT01011725|"~     This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic~     efficacy of MK0773 in healthy postmenopausal women.~   "
194947|NCT01011712|"~     Background:~        -  Infections caused by viruses are common causes of illnesses: the common cold, many ear~          infections, sore throats, chicken pox, and the flu are caused by different viruses.~          Usually, these illnesses last only few days or, at most, a few weeks. Some virus~          infections like influenza are cleared from the body, and others such as the chicken pox~          virus remain in the body in an inactive state. However, some people may become quite ill~          when they are infected with a particular virus, possibly because part of their immune~          system does not respond properly to fight the virus.~        -  Researchers have discovered some reasons why a person may not be able to clear an~          infection caused by a virus. Some persons have changes in the genes that involve the~          immune system that result in the inability to properly control infection with a~          particular virus. Identifying changes in genes that involve the immune system should~          help scientists better understand how the immune system works to protect people from~          infection and may help develop new therapies.~      Objectives:~        -  To study possible immune defects that may be linked to a particular severe viral~          infection.~        -  To determine if identified immune defects are genetic in origin.~      Eligibility:~        -  Individuals of any age who have or have had a diagnosis of a virus infection that~          physicians consider to be unusually severe, prolonged, or difficult to treat.~        -  Relatives of the participants with a severe viral infection may also participate in the~          study. We will use their blood and/or skin specimens to try to determine if identified~          immune defects are hereditary.~      Design:~        -  Prior to the study, the participant's doctor will give researchers the details of the~          infection, along with medical records for review. Eligible participants will be invited~          to the NIH Clinical Center for a full evaluation as an outpatient or inpatient.~        -  At the Clinical Center, participants will be treated with the best available therapy for~          the particular viral infection, and researchers will monitor how the infection responds~          to the treatment.~        -  Researchers will take intermittent blood samples and conduct other tests (such as skin~          biopsies) to evaluate the immune system. - During and after the illness, researchers~          will conduct follow-up visits to determine the course of infection and response to~          therapy.~   "
194948|NCT01011699|"~     The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic~     hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the~     phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in~     other biological parameters, vascular calcification and bone mass loss and on the clinical~     and biological tolerance and finally to explore the roles of metabolites of nicotinamide.~   "
194949|NCT01011686|"~     Fecal incontinence affects 18.4% adults in the community and greatly impacts quality of life.~     There's a problem like inconvenience, pain or allergic response in many therapeutic methods~     such as a surgical operation or material injection. ANT-SM is autologous adipose-derived stem~     cell, and so, expect of no immune responses. In this study, patients are given injection of~     ANT-AM in anal sphincter and followed for 4 weeks to test the safety.~   "
194950|NCT01011673|"~     Occasionally, episodic tension-type headache may be severe enough to require an emergency~     department (ED) visit. The purpose of this study is to compare two commonly used medications~     to see which is better for tension type headache. Patients who present to the ED with an~     acute tension-type headache requiring treatment with injectable medication will be randomized~     to metoclopramide or ketorolac.~   "
194951|NCT01011660|"~     The aim of the study is to investigate the optimized treatment strategy of hypertension, so~     as to make more patients to reach the blood pressure goals and to reduce~     cardio-cerebrovascular events. Objective and Methods: Patients are eligible for inclusion in~     the study if they are essential hypertension, 50-79 years of age with at least one~     cardiovascular risk factor and sign the informed consent forms. This project is a~     multi-centre, prospective randomized,，openlabel blind-endpoint evaluation controlled (PROBE)~     trial. 12000 patients will be randomly assigned to either of low-dose Amlodipine+Telmisartan~     group or Amlodipine+ diuretics group. Among those patients with serum cholesterol between~     4.0-6.1mmol/L, they will be also randomized into small dose of statin-based regimen or~     standard management regimen; Patients will also randomly assigned to intensive lifestyle~     intervention group or standard intervention group according to the community area where the~     patients in.~   "
194954|NCT01011621|"~     Topical corticosteroids are largely used in dermatology. The major problem related to their~     use is that the same mechanisms underlying their therapeutic effects (antiinflammatory and~     antiproliferative) may lead to adverse events. Conditions sensitive to corticosteroids~     require formulations with mild to moderate potency while high-potency corticosteroids era~     required in less responsive conditions. The aim of the present study is to compare the safety~     and efficacy of prednisolone acetate 0.5% cream (mild-potency non-fluoridated corticosteroid)~     versus betamethasone valerate 0.1% cream (high-potency fluoridated corticosteroid) in the~     treatment of mild to moderate cortisosensitive dermatosis (atopic dermatitis, contact~     dermatitis, seborrheic dermatitis and psoriasis). The study hypothesis is that 0.5%~     prednisolone cream will be as effective as 0.1% betamethasone cream and will be an~     alternative option to treat corticosensitive dermatosis in body areas where the use of~     fluoridated corticosteroids is contraindicated, such as the face.~   "
194955|NCT01011608|"~     The objective of this study is to evaluate the effect of nutritional supplementation on the~     nutritional and clinical course of patients admitted to the hospital for hip fracture~     surgery.~   "
194956|NCT01011595|"~     The gold standard techniques to assess the extent of disease and decide on therapy for~     patients with lung cancer consists of cervical mediastinoscopy, which is a surgical procedure~     which entails an incision in the neck and the removal of lymph nodes from around the airway.~     Endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) are new, non-surgical~     techniques that have been available for the past several years and are proving invaluable in~     lung cancer evaluation. These techniques are minimally invasive and can be performed without~     surgery.~      To date, there have been no head-to-head studies on the same group of patients using both the~     old and new techniques. The study will consist of a study which compares traditional staging~     techniques in lung cancer patients to new, less invasive techniques.~      The significance of the proposed project is tremendous. If the new strategies prove to be~     equivalent (or superior) to traditional techniques, these techniques will be considered the~     new gold-standard tests. This will change the way lung cancer is evaluated. An equivalent or~     superior result will also significantly impact on patient care, cost and morbidity due to the~     speed, convenience and lack of operating room requirement as well as the lack of general~     anesthesia.~   "
194957|NCT01011582|"~     The purpose of this research study is to collect information on problems that patients with~     the novel H1N1 influenza and/or the seasonal influenza experience. Novel H1N1 flu is also~     called the swine flu. Seasonal influenza is also called the regular flu. The purpose of this~     study is to collect information from patients who are infected with either the novel H1N1 or~     the seasonal flu and to determine what makes patients critically ill with these infections.~     The goal is to develop a registry that will aid investigators in determining specific markers~     that lead to development of severe illness in these infections.~   "
194958|NCT01011569|"~     There are largely 2 surgical methods for one-level cervical disc disease; cage only and~     plate/graft. Even there are many reports about the efficacy of either cage only or~     plate/graft, prospective comparative study is few. The object of the present study is to~     present design of prospective study and to demonstrate preliminary result.~   "
194959|NCT01011556|"~     The primary purpose of this study is to help answer the following research questions:~        1. How teriparatide given using a skin patch (transferred through the skin using the~          ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a~          needle (pen injector) affects your bone density (how solid or porous your bones are).~        2. The safety of the teriparatide skin patch and any side effects that might be associated~          with it.~   "
194960|NCT01011543|"~     This is a randomised study that compares different diagnostic approaches for diagnosing~     pulmonary tuberculosis in patients suspected of pulmonary tuberculosis in whom the three~     classic (non-induced) sputum samples didn't show tuberculous bacillus on direct examination.~      The investigators compare the sensibility of induced sputum technique with an endoscopic~     approach (CT-scan followed by BAL and fluoroscopy-guided transbronchial biopsies and~     eventually sputum collection immediately after the bronchoscopy).~      People in high risk population for tuberculosis undergoing screening by chest X-ray or~     symptomatic patients will be admitted to the hospital if their chest X-ray shows a suspicion~     of active tuberculosis.~      According good clinical practice: (non-induced) sputum samples will be taken at admission and~     every following morning. If direct examination and PCR of the first three classic sputum~     samples are negative: patients will be randomised in two groups with a different diagnostic~     approach (induced sputum versus endoscopic approach) The aim of our study is to proof that a~     thoroughgoing endoscopic approach has a higher sensibility than an induced sputum in the~     diagnosis of pulmonary tuberculosis in patients with a high suspicion of active tuberculosis~     on the chest X-ray but with a negative direct examination and/or PCR on three consecutive~     normal sputum samples.~      The investigators will include 154 patients (based on a statistical analysis for a hypothesis~     that the endoscopic approach has a sensibility that's twice the sensibility of the induced~     sputum).~        -  first arm: 2 consecutive induced sputum using an ultrasonic nebulizer.~        -  second arm: CT thorax to evaluate the exact anatomic localisation of the disease~          followed by fluoroscopy-guided bronchoscopy for BAL (bronchoalveolar lavage) and~          transbronchial biopsies. A sputum sample immediately after the endoscopy will be~          collected if possible.~   "
194961|NCT01011530|"~     This is an open-label, multicenter, phase 1, dose escalation study that will evaluate the~     safety profile, establish Maximum Tolerated Dose (MTD), and inform the recommended phase 2~     dose of MLN4924 as well as evaluate antitumor activity in patients with metastatic melanoma.~   "
194962|NCT01011517|"~     The investigators sought to evaluate the effect of muscadine grape seed supplementation on~     brachial diameter and flow-mediated vasodilator responses in subjects with, or at risk for~     cardiovascular disease.~      Methods: In a randomized, double-blind, placebo-controlled crossover trial, 50 adults (25~     men, 25 women) with one or more cardiac risk factors were randomized to muscadine grape seed~     (MGS) supplement 1300mg daily vs.. placebo for 4 weeks each, with a 4-week washout between~     study periods. Resting diameter and endothelial function measured using brachial~     flow-mediated dilation (FMD) were determined at the beginning and end of each study period.~   "
194963|NCT01011504|"~     The objective of this study is to determine utilisation patterns in patients receiving~     Angiox® in participating European centres. Additionally, through the collection of~     descriptive safety and outcomes data, this study will contribute to the Risk Management~     strategy for Europe~   "
194964|NCT01011491|"~     Portion-controlled meal replacements have been shown to be an effective weight control~     strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the~     effect of Medifast's 5 & 1 program compared to an food-based diet plan of equal calories on~     the following indices: weight loss and maintenance of weight loss, satiety during weight~     loss, changes in biochemical markers of inflammation and oxidative stress following weight~     loss, and compliance and retention rates.~   "
194979|NCT01011296|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.~   "
194965|NCT01011478|"~     RATIONALE: Rosuvastatin may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving rosuvastatin after surgery may kill any tumor cells that~     remain after surgery. It may also keep polyps from forming or colon cancer from coming back.~     It is not yet known whether rosuvastatin is more effective than a placebo in treating colon~     cancer that was removed by surgery.~      PURPOSE: This randomized phase III trial is studying rosuvastatin to see how well it works~     compared with placebo in treating patients with stage I or stage II colon cancer that was~     removed by surgery.~   "
194966|NCT01011465|"~     Positive social relationships have consistently been associated with better health, although~     the neurobiological underpinnings of these observed effects remain largely unknown. The~     overall goal of the proposed work is to explore novel biological pathways that may explain~     how social relationships influence health. Recent theorizing suggests that the oxytocin~     system may underlie some of the observed beneficial effects. Four hypotheses will be~     examined:~        1. Oxytocin ameliorates the deleterious neuroendocrine, cardiovascular, and subjective~          effects of stress.~        2. Oxytocin and social support have similar and additive stress-buffering effects.~        3. Effects of oxytocin are evident among younger and older adults.~        4. Effects of oxytocin are stronger in women vs men.~   "
194967|NCT01011452|"~     Patients presenting to hospital with an acute asthma exacerbation severe enough to require~     admission would receive full standard treatment according to British Thoracic Society~     guidelines in addition they would be offered the opportunity to take part in the study which~     would requite them to take a capsule of either montelukast or placebo.~   "
194968|NCT01011439|"~     The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line~     treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously~     treated with chemotherapy.~   "
194969|NCT01011426|"~     The purpose of this study is to determine whether Bisacodyl, 5 mg usage decreases the~     incidence of nausea and abdominal pain after surgery, and also decreases the number of~     hospitalization days.~   "
194970|NCT01011413|"~     Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV),~     could be reduced without compromising its effectiveness. Lower drug doses could have fewer~     side effects and would make EFV more affordable. The purpose of this study is to compare the~     safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV~     in controlling HIV as part of initial combination antiretroviral therapy.~   "
194971|NCT01011400|"~     Abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies.~     To the investigators knowledge there is no published nomogram of the clitoris size through~     gestation and it's assessment is usually subjective. The purpose of this study is to create a~     nomogram of clitorial size through gestation by measuring its size in fetuses of different~     age in the second and third trimester.~   "
194972|NCT01011387|"~     Primary objective~        -  To assess wound healing and granulation tissue formation when using the NPWT system~      Secondary objectives~        -  To investigate the pain level at dressing removal~        -  To visually check exudate removal~        -  To investigate the ease of use for the subject and care giver when using the NPWT system~   "
194973|NCT01011374|"~     This is a prospective, single-center, non-randomized clinical study on the impact of~     intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning~     and emotional well-being in subjects with central or branch retinal vein occlusion.~   "
194974|NCT01011361|"~     On the basis that the clinical consequences of seemingly trivial levels of anemia are~     surprisingly severe, this study investigates if hemoglobin concentration accurately~     represents the underlying red cell mass in elderly patients with unresolved anemia.~   "
194975|NCT01011348|"~     Goal: The investigators propose to test whether giving the supplement coenzyme Q10 (Q10)~     improves symptoms and subjective health in Gulf War veterans (GWV) with chronic,~     multi-symptom health problems.~      Rationale: Direct empirical evidence, in groups that are not GWV, has supported benefit of~     Q10 to many of the symptoms that GWV are at heightened risk of experiencing - such as~     fatigue, muscle pain, and cognition, which are syndrome-defining conditions. In addition, Q10~     has also been reported to benefit other symptoms arising at increased rates in GWV, including~     headaches, sleep disturbances, and breathing problems. This provides a strong rationale for~     testing whether Q10 will have similar benefit to these symptoms in GWV.~      Method: 46 GWV with chronic health problems will participate.The design is a randomized,~     double-blind, placebo-controlled crossover study. Each subject will be crossed over between~     Q10 and an identical placebo, receiving each agent twice, for 3.5 month periods. In one of~     the Q10 phases, a lower dose of Q10 will be used - 100mg three times a day; while in one a~     higher dose will be used - 300mg three times a day. Neither subjects nor investigators will~     know which substance each subject is receiving in which phase. Subjects will be randomly~     assigned to one of four crossover orders.~      Assessments: Assessments will include subjective quality of life; symptoms that are syndrome~     defining for Gulf War illness (like fatigue and muscle problems); and other symptoms and~     conditions reported to occur more commonly in GWV (like sleep problems). Analyses will show~     whether Q10 led to improvements when compared to placebo; whether higher Q10 doses improved~     outcomes more than lower doses; and whether people with certain symptoms or characteristics~     get more benefit than people with other symptoms or characteristics.~   "
194976|NCT01011335|"~     This study involves the use of investigational vaccines. A vaccine is a medicine that causes~     the body to make antibodies. Antibodies help destroy foreign substances that enter the body.~     The purpose of this study is to find the right dose of a new vaccine that is safe and~     produces a good immune response (how well your body recognizes and defends itself against~     harmful foreign substances). There are two Staphylococcus aureus toxoids (components or~     antigens) under investigation in this study; one of them is a protein known as rAT and the~     other is a protein known as rLukS-PV. They are being developed to see if they are effective~     at preventing infections caused by the bacteria Staphylococcus aureus.~   "
194977|NCT01011322|"~     The participation in this clinical study will last approximately 21 weeks with a 1 week~     screening period and a 12 weeks treatment duration. If the study doctor finds, that the~     patients disease has significantly improved he/she will enter a treatment free follow-up~     period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1~     telephone follow-up call.~   "
194981|NCT01011270|"~     Workers in the various branches of the investigators industrial society can be considered as~     a group susceptible to risks due to the nature of its activities related to the intense~     demands of their work units with varying degrees of physical overload. Among the risk factors~     involved in postural genesis of occupational low back pain is work in uncomfortable~     positions, such as maintenance of static postures for long periods of time and frequent~     implementation of flexion, extension and trunk rotation.The association between body~     instability (lack of postural balance) and back pain is seen with some frequency, especially~     in working groups.~   "
194982|NCT01011257|"~     The investigators will test the hypothesis that aspirin or clopidogrel taken twice daily will~     augment their antiplatelet efficacy in patients with an elevated platelet turnover (as~     measured by the proportion of reticulated (young) platelets) compared with once daily dosing.~   "
194983|NCT01011244|"~     Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is~     high. On 15 October 2008, orphan designation was granted by Korea FDA for human~     adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study,~     patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to~     evaluate the safety and efficacy.~   "
194984|NCT01011231|"~     The purpose of this study is to assess the efficacy, of treating patients with recurrent~     glioblastoma using Gamma-Knife Radiosurgery (GKS) to target a tumor volume defined by a~     combination of gadolinium enhancement and magnetic resonance spectroscopy (MRS). This is a~     single center, Phase II trial. A total of 40 glioblastoma patients will be enrolled into the~     primary arm of the trial. In addition, a minimum of 10 patients with recurrent anaplastic~     (grade III) gliomas and a minimum of 10 patients with recurrent low-grade (grade II) gliomas~     will be enrolled into exploratory arms.~      The investigators hypothesize that the use of a combination of gadolinium enhancement and~     elevated Cho:NAA ratio via MRS to determine the treatment target volume for Gamma Knife may~     be an effective way to treat focally-recurrent glioblastoma.~   "
194985|NCT01011218|"~     Primary Objective:~        1. To provide preliminary data on the effects of armodafinil and Brief Behavioral Therapy~          for Insomnia (BBT-I) (alone or in combination) on insomnia in breast cancer patients~          receiving chemotherapy.~      Secondary Objectives:~        1. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in~          combination) on cancer-related fatigue (CRF) in breast cancer patients receiving~          chemotherapy.~        2. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in~          combination) on QOL in breast cancer patients receiving chemotherapy.~        3. To provide preliminary data on influence of armodafinil and BBT-I (alone or in~          combination) on endocrine and inflammatory physiological markers (measured by cortisol~          and inflammatory cytokines markers)~   "
194986|NCT01011205|"~     Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which~     may have the potential to cause fewer kidney problems.~   "
194987|NCT01011192|"~     The aim of this study was to assess the clinical performance of two different ke0s (fast and~     slow) in terms of propofol effect-site concentration (Ce) during the loss and recovery of~     consciousness, using Marsh's pharmacokinetic model.The hypothesis to be tested was that the~     Ce of propofol predicted by the slow ke0 in the loss and recovery of consciousness is~     similar, differently from the fast ke0.~   "
194988|NCT01011179|"~     This study will evaluate the feasibility of Teens Taking Charge: Managing Arthritis On-line~     intervention that will help adolescents with arthritis to better manage their disease and~     improve their health-related quality of life (HRQL).~   "
194989|NCT01011166|"~     This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of~     IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with~     hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for~     future, longer term studies.~   "
194990|NCT01011153|"~     This survey study purposes to determine and compare the biopsy/referral sensitivity and~     specificity of MelaFind to the average biopsy/referral sensitivity and specificity of~     dermatologists. 241 subjects logged into system but only 183 signed consents and completed~     the intake survey. Out of these 183, 155 were accounted for in the data analysis after~     exclusions were removed from the pool of subjects.~   "
194991|NCT01011140|"~     The purpose of this study is to assess palliative care physicians' attitudes, beliefs and~     practice patterns related to parenteral hydration at the end of life in Latin America and~     Spain.~      Objectives:~        1. To assess palliative care physicians' attitudes, beliefs and practice patterns related~          to parenteral hydration at the end of life in Latin America and Spain.~        2. To assess cross-national differences in practice patterns related to parenteral~          hydration at the end of life. (Latin America vs. Spain).~        3. To determine the percentage of physicians who practice parenteral hydration at the~          end-of-life in the hospital setting and the home setting.~        4. To examine the association between providers' parenteral hydration practice patterns~          and:~             -  1. provider demographic characteristics;~             -  2. specific characteristics of their practice settings; and~             -  3. training and experience in end of life care;~        5. To determine which factors most predict the practice of parenteral hydration at the end~          of life among palliative care physicians.~   "
194992|NCT01011127|"~     The investigators hypothesize that pravastatin and rosuvastatin may have different metabolic~     effects in hypercholesterolemic patients.~   "
194993|NCT01011114|"~     The purpose of the study is to determine whether cinacalcet, used in patients with secondary~     hyperparathyroidism to control excessive parathyroid hormone, can normalize low blood~     phosphorus that is commonly seen in patients who have had a kidney transplant.~   "
195019|NCT01010776|"~     The purpose of this study is to evaluate effectiveness, tolerability (how well a participant~     can stand a particular medicine or treatment), and safety of flexible-dose of paliperidone~     extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms~     of emotional instability, detachment from reality, often with delusions and hallucinations,~     and withdrawal into the self), previously taking risperidone (an antipsychotic), but who are~     not satisfied with their treatment.~   "
195020|NCT01010763|"~     The purpose of this study includes the investigation of Metal-ion release and Renal Function~     analysis in M2a Total Hip Arthroplasty.~   "
195021|NCT01010750|"~     To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based,~     battery of neuro-psychometric tests in adults with ADHD.~   "
194994|NCT01011101|"~     Background:~        -  Researchers are studying how humans are able to move our eyes to a remembered region~          even when the target has disappeared. The ability to do this suggests that the brain can~          keep track of where the eyes have looked, without an external target for continued~          reference. This is called corollary discharge.~        -  Other research has indicated that patients with schizophrenia might have difficulty~          monitoring their eye movements. The corollary discharge process may be defective in~          patients with schizophrenia, and perhaps delayed in time. Researchers have developed a~          test to examine this possibility in the hope of learning more about schizophrenia and~          eye movement.~      Objectives:~      - To assess whether there is a defect in internal monitoring of eye movements in patients~     with schizophrenia.~      Eligibility:~        -  Individuals over 18 years of age who are able to give informed consent and are able to~          concentrate on a 20-minute task that involves following projected targets and moving~          their eyes to remembered locations.~        -  Individuals with schizophrenia will be recruited from an ongoing NIH protocol studying~          schizophrenia.~        -  In addition healthy will be recruited for this protocol.~      Design:~        -  Researchers will check participants' vision in each eye, and ask them to sit at a~          machine that measures eye movement in order to complete research tasks. Researchers will~          monitor participants ability to complete these tasks.~        -  The first task involves simply following a target that jumps to different parts of the~          screen.~        -  The second is a 2-step task, in which a participant is asked to look at two separate~          light targets and then look at the remembered target positions when the lights are off.~        -  This protocol does not provide treatment. Participants will remain under the care of~          their own physicians during participation in this protocol.~   "
194995|NCT01011088|"~     A large number of studies have investigated the psychological disorders occurred in~     postpartum women, and found that postpartum psychosis is common in new mothers.~      However, the situation of paternal psychological status after they had their first baby is~     not assessed. The investigators hypothesized that they had a high occurrence of paternal~     psychosis after first baby born. In addition, different factors might influence its onset and~     development in new fathers.~   "
194996|NCT01011075|"~     This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a~     PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients~     with advanced, non-small cell lung cancer.~   "
194997|NCT01011062|"~     The study aims to investigate the effect of acute angiotensin receptor blockade on insulin~     action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose~     tissue in insulin-resistant subjects with type 2 diabetes and healthy controls.~      Hypothesis: Changes in adipocytokine concentrations and/or expressions and different~     reactions to acute in vivo induced hyperinsulinemia and angiotensin receptor blockade will be~     found in patients with type 2 diabetes compared to healthy subjects. A significant~     relationships between insulin sensitivity and selected adipokines and intracellular fat~     content and high energy phosphates in soleus muscle will be documented in healthy~     individuals, while no significant relation will be found in patients with type 2 diabetes.~   "
194998|NCT01011049|"~     The purpose of this study is to generate additional data on the immunogenicity and safety of~     revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.~      Primary Objective:~        -  To evaluate and describe the safety profile of revaccination with Fluzone ID for all~          participants.~      Secondary Objective:~        -  To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.~   "
194999|NCT01011036|"~     The investigators will use an intradermal capsaicin injection in the forearm to induce a~     state of localized pain. This localized pain will be measured by different means, and~     analysed locally and distally by so called quantitative sensory testing. The primary endpoint~     of measure is the difference in pain perception with and without~     benzodiazepines/GABA-Agonists around the injection point of capsaicin. The secondary~     endpoints are to measure pain modulation locally and distally by different quantitative tests~     as electricity, pressure pain thresholds, and ice water tests.~      The investigators' hypothesis is that clobazam induces higher pain thresholds as placebo and~     less sedation than the control medication clonazepam.~   "
195000|NCT01011023|"~     Objective. To study the role of nasogastric drainage to prevent postoperative complications~     in children with <b>distal</b> elective bowel anastomosis. Summary Background Data.~     Nasogastric drainage has been used as a routine measure after gastrointestinal surgery in~     children and adults, to hasten bowel function, prevent post operative complications and~     shorten hospital stay. However, there is no former study that states in a scientific manner~     its benefit in children. Methods. The investigators performed a clinical controlled,~     randomized trial, comprising 60 children that underwent distal elective bowel anastomoses~     comparing post operative complications between a group with nasogastric tube in place (n=29)~     and one without it (n=31). <b>As an equivalence study the investigators expected that the two~     techniques were equivalent.</b> Statistics: Descriptive statistics for global description.~     Student's t test for quantitative variables and chi square test for qualitative variables.~     Considering statistically significant a p-value less than 0.05. <b>Being an equivalence~     study, the default delta generated by the Stata command equim was used to demonstrate the~     equivalence between both groups.</b> Results: Demographic data and diagnosis were comparable~     in both groups (p=NS). No anastomotic leakage or entero-cutaneous fistulae was found in any~     patient. The investigators demonstrated equivalency since each confidence interval is~     entirely contained within delta, except for one variable (beginning deambulation), in which~     equivalency is suggested. There were no significant differences between groups in abdominal~     distention, infection, or hospital stay variables. Only one patient in the experimental group~     required placement of the nasogastric tube due to persistent abdominal distension (3.2%).~     Conclusions. The routine use of nasogastric drainage can be eliminated after distal elective~     intestinal surgery in children. It's use should be individualized.~   "
195001|NCT01011010|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as doxorubicin hydrochloride and mitomycin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking~     the blood flow to the tumor. Giving sorafenib tosylate together with chemoembolization may~     kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of sorafenib tosylate when given~     together with chemoembolization with doxorubicin hydrochloride and mitomycin in treating~     patients with liver cancer that cannot be removed by surgery.~   "
195002|NCT01010997|"~     The FORESEE HOME is intended for the early detection of central and paracentral~     irregularities (abnormalities) in the visual field, most commonly associated with AMD.~     However, the device has ability to detect the development of the lesion post treatment and~     therefore to asses in determination of the next treatment.~   "
195003|NCT01010984|"~     The purpose of this study is to determine if LC beads loaded with Doxorubicin are a safe and~     effective treatment for melanoma that has spread to the liver.~   "
195004|NCT01010971|"~     This clinical research study will evaluate the safety and effectiveness of two doses of an~     investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of~     seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm~     study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to~     the proper use of the study medication and to assess the subject's severity of SAR symptoms,~     followed by a 2-week double-blind treatment period to assess the safety and effectiveness of~     the study medication when given to eligible subjects.~   "
195005|NCT01010958|"~     For patients initially presenting with localized sarcoma the standard of care is surgery~     followed by with radiation therapy (if feasible). Subsequent or adjuvant cytotoxic based~     chemotherapy even for aggressive sarcoma histopathologies (as commonly done for colorectal~     cancer or breast cancer) is controversial since over 20 individual adjuvant randomized~     clinical trials have not been able to consistently demonstrate a statistically significant~     improvement in overall survival. Maturation or differentiation therapy provides an~     opportunity to fundamentally change the biology of the underlying cancer (and thus its~     overall prognosis) by promoting cellular maturation within that cancer. A change from a~     poorly 'differentiated/high grade' tumor to a well 'differentiated/low grade' tumor is~     attainable and can change an individual's median time of survival from months to decades. The~     investigators have significant preclinical data that differentiation therapy using a group of~     drugs referred to as histone deacetylase inhibitors (such as Valproate, also a commonly used~     and safe anti seizure medication) is feasible for sarcomas. This approach has not been~     clinically addressed in solid tumors. Since adjuvant therapy is controversial for sarcomas,~     and building on the investigators' preclinical data, adjuvant based differentiation therapy~     using valproate would be predicted to be both safe and potentially extremely beneficial in~     terms of a) increasing the time to disease recurrence, b) improving the histology upon~     recurrence; and c) improving overall survival in patients with sarcomas.~      Patients with high grade sarcomas will receive Valproate in the adjuvant setting daily and~     clinically/radiologically followed until recurrence. Relapse free survival, time to local~     failure, time to distant failure, overall survival, and comparative histopathology of primary~     and recurrence will be assessed.~   "
195006|NCT01010945|"~     This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib)~     and nab-paclitaxel in patients with advanced pancreatic cancer.~   "
195007|NCT01010932|"~     The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering~     from carotid or vertebral arterial disease.~   "
195008|NCT01010919|"~     Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of~     arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled,~     double blind, dose-escalating trial is to determine the safety and tolerability of a~     proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary~     objectives are to assess effects on the signs and symptoms of this disorder. Individuals~     greater than 50 years of age with OA of the hip or knee will be eligible for trial entry.~   "
195009|NCT01010906|"~     This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir~     (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy~     matched control participants. The primary hypothesis is that the area under the curve (AUC)~     (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic~     insufficiency is similar to that observed in healthy matched controlled participants.~   "
195010|NCT01010893|"~     To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in~     adults and elderly people, with the objective to verify efficacy and tolerability of the~     study drug.~   "
195011|NCT01010880|"~     BKT-140 drug substance is a highly selective chemokine receptor (CXCR4) antagonist, which is~     developed by Biokine as a novel therapy for Multiple Myeloma (MM, a type of blood cancer).~     The unique combination of activities of BKT140, i.e., the induction of the exit of blood~     cells such as stem cells and mature cells from the bone marrow to the peripheral blood,~     coupled with specific induction of MM cell death by BKT-140, represents a novel therapeutic~     strategy against MM.~   "
195012|NCT01010867|"~     Primary Objective:~      1. To evaluate the safety of orally administered Lactobacillus plantarum strains 299 and~     299v, a probiotic, in patients undergoing allogeneic myeloablative HSCT, as measured by~     incidence of Lactobacillus plantarum bacteremia.~      Secondary Objectives:~        1. To investigate the feasibility of administering Lactobacillus plantarum 299 and 299v to~          children and adolescents undergoing HSCT.~        2. To describe the overall incidence of bacteremia in HSCT patients who have been~          administered Lactobacillus plantarum.~        3. To describe the overall incidence of acute graft versus host disease (GVHD) in HSCT~          patients who have been administered Lactobacillus plantarum.~   "
195013|NCT01010854|"~     The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are one of the approved~     options to treat Locally Advanced or Primary Metastatic Breast Cancer. In this study, the~     investigators will add another drug called Valproic Acid (VPA) to see whether this makes the~     treatment better. The addition of Valproic Acid to chemotherapy has been studied in about 65~     subjects with cancer and was found to be safe and tolerable. Valproic Acid is approved by the~     Food and Drug Administration (FDA) for the treatment of seizures, mood swings, and migraine~     headaches. It is not currently approved for cancer, which is why the investigators are~     conducting this study.~      The results of a Phase I study of Valproic Acid and FEC100 in subjects with cancer that has~     spread has led the investigators to believe that this combination is better than just the~     standard treatment alone. The investigators are now testing the combination in a study with~     subjects who have either a large tumor, many lymph nodes involved or patients whose tumor has~     spread. In addition to the treatment, a main goal of the study is to find out which subjects~     will benefit from this combination. In the Phase I trial the investigators noticed that while~     this combination appears to make the chemotherapy more effective, it did not appear to cause~     more side effects induced by the chemotherapy.~   "
195014|NCT01010841|"~     The objective of this study was to investigate from 3 sites (University of Connecticut,~     University of Florida, and University of California, Irvine) whether enhancement of a~     modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy~     protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve~     cardiometabolic risk factors in women with metabolic syndrome.~   "
195015|NCT01010828|"~     This study will show whether Tri-Vector method can ensure more extensive visual field and~     conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types~     of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in~     Vanguard PS artificial knee joint total replacement observational period before and during~     surgery.~   "
195016|NCT01010815|"~     The researchers will investigate gut microbiome in Korean patients with ulcerative colitis~     and normal control subjects using metagenomic analysis to elucidate the significant~     difference between two groups This study will help to understand the association between gut~     microbiome and inflammatory bowel disease.~   "
195017|NCT01010802|"~     The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is~     safe in the treatment of patients with Parkinson's Disease.~   "
195018|NCT01010789|"~     The purpose of this research study is to study the effectiveness, tolerability and safety of~     armodafinil in outpatients with binge eating disorder.~   "
195036|NCT01010555|"~     The purpose of this study is to investigate the front surface wettability of soft contact~     lenses while on eye.~   "
195023|NCT01010724|"~     The study drug bIAP, or matching placebo, will be administered as a bolus of 1000 Units bIAP~     or matching placebo prior to anaesthesia (T = -15 minutes), directly followed by intravenous~     continuous infusion of about 5.6 units per kg bodyweight/hr at pump rate 4 ml/hr for~     approximately 36 hrs (total 200 IU/kg/36 hrs) into each of a total of 50 patients scheduled~     for coronary artery bypass graft surgery (CABG). Risk of surgical complications and mortality~     due to co-morbid conditions will be collected and the EuroSCORE will be used to screen~     patients prior to surgery.~   "
195024|NCT01010711|"~     Migraine in children and adolescents can be associated with low serum levels of coenzyme q10,~     the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an~     important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults~     it is hypothesized that daily supplementation of coenzyme q10 as well as different~     antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to~     reduce the days with migraine as primary parameter (open clinical trial).~   "
195025|NCT01010698|"~     The Biopharmaceutics Classification System (BCS) is employed by the US FDA to categorize drug~     substances into 4 classes and to characterize drugs in terms of aqueous solubility and~     intestinal permeability. The four BCS categories for a drug substance are Class 1, Class 2,~     Class 3, and Class 4. Biopharmaceutical properties of aqueous solubility and intestinal~     permeability with drug product dissolution determine the rate and extent of drug absorption~     from immediate-release (IR) and solid oral dosages forms (e.g. tablets,capsules). Each class~     exhibits information regarding biopharmaceutic properties and bioequivalence. For example,~     Class 1 drugs have the most favorable oral biopharmaceutic properties (high solubility and~     high permeability). With these biopharmaceutic properties for class 1 drugs, results in vivo~     bioequivalence (BE) studies for rapidly dissolving IR solid oral dosage forms the FDA~     provided waivers. This approach alone has resulted in new and generic drugs approved based on~     vitro data alone (i.e. biowaived), with great savings in resources and reduction in~     unnecessary human testing.~      Objectives: 1) The primary objective of this study is to assess whether common excipients~     cause bioinequivalence of Class 3 drugs. 2) The secondary objective is the results of the~     study will contribute towards providing scientific evidence to the FDA for consideration of~     Class 3 drugs for BCS-based biowaivers.~      Hypotheses: The investigators anticipate that common excipients do not cause~     bioinequivalence. 1) Hence, the hypothesize of this study is commonly used excipients in oral~     medications (tablets, capsules) modulate the rate or extent of Class 3 drug absorption and~     result in bioinequivalence. 2) Alternative hypothesis is that commonly used excipients in~     oral medications (tablets, capsules) do not modulate the rate or extent of Class 3 drug~     absorption and do not result in bioinequivalence.~   "
195026|NCT01010685|"~     The benefits of laparoscopic (minimally invasive or keyhole) surgery for gallbladder~     removal (cholecystectomy) over open surgical procedures in terms of significant reductions in~     pain, scarring and recovery time are well accepted. In a conventional laparoscopic~     cholecystectomy however, the excised gallbladder still has to be extracted through the~     abdominal wall skin via a laparoscopic port site using an incision of 10mm or greater.~     Despite being much smaller than that required for open surgery, this incision is painful,~     leaves a scar and can result in a port site hernia to follow requiring further surgery to~     repair it. Recent attempts to further reduce the invasiveness of the surgical procedure have~     suggested performing the operation via an endoscope passed through the mouth and through an~     incision in the stomach wall - so called Natural Orifice Translumenal Endoscopic Surgery~     (NOTES). Unlike a skin incision, an incision in the wall of the stomach (gastrotomy) should~     give no pain, visible scar or herniation risk yet still allow access to the peritoneal cavity~     for surgical procedures such as cholecystectomy. Against this, it has the potential risks of~     contamination and leakage of gastric contents into the peritoneal cavity. Whilst the~     limitations of present technology make it very difficult to perform an entire cholecystectomy~     through the stomach wall in patients, endoscopic methods for closing a gastrotomy are~     available that are approved for use in patients (CE marked) and it is hypothesised that~     removing the excised gallbladder through the stomach in this way would avoid the problems of~     extracting it through the abdominal wall described above. Data are required to determine~     whether the extraction of the gallbladder via a gastrotomy rather than through the skin is~     safe, producing smaller scars and a better cosmetic result. A secondary endpoint would be to~     assess possible reductions in pain and recovery from this less invasive approach.~   "
195027|NCT01010672|"~     The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to~     patients with metastatic bone or soft-tissue sarcoma in Japan.~   "
195028|NCT01010659|"~     The purpose of study is to investigate the safety and efficacy of lacrimal silicone~     intubation for the management of epiphora.~   "
195029|NCT01010646|"~     Three-parallel-arm, open-label, international (France and Romania) study, comparing three~     treatments~      The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and~     tolerability as compared with current marketed reference, while combined with ribavirin, in a~     3-month therapy setting.~   "
195030|NCT01010633|"~     This study is being conducted to compare the safety and efficacy of loteprednol etabonate~     compared to vehicle for the treatment of postoperative inflammation and pain following~     cataract surgery.~   "
195031|NCT01010620|"~     The Screening Protocol is a system devised to evaluate potential research participants for~     National Institute on Drug Abuse/Maryland Psychiatric Research Center (NIDA/MPRC) studies.~   "
195032|NCT01010607|"~     Upper limb paralysis following stroke is a very common problem. Only 30% of stroke patients~     who suffer from upper limb paresis experience a full recovery of function. There is a need~     for the development of more efficient rehabilitation methods for the improvement of the~     paralysed upper limb function.~      It has been shown that the use of mirror therapy after a stroke induces the activation of~     motor, sensory and associative regions in the affected hemisphere and is associated with an~     improvement in the function of the affected limb. Mirror therapy is a treatment modality in~     which the affected arm is hidden from the patient's sight; the patient is instructed to watch~     the reflection of his healthy hand on a mirror while he performs movements with his healthy~     hand and tries to move simultaneously his affected hand. This induces the illusion that his~     affected hand moves well.~      It has also been shown that applying vibration to a muscle tendon at frequencies between~     50-100 Hz induces an illusion of elongation of the vibrated muscle, if visual feedback is~     prevented. For instance, vibrating the triceps will induce a strong illusion of elbow~     flexion.~      In the present study the investigators will couple the use of a mirror with the application~     of vibration to tendons, in order to obtain a multisensorial and strong illusion of movement~     in the paralyzed limb.~      The study hypothesis is that the administration of mirror therapy together with vibration~     will induce the activation of multiple motor, sensory and associative areas in the affected~     brain hemisphere, resulting in improvement of the affected upper limb function, compared to~     the administration of mirror therapy alone or sham therapy.~   "
195033|NCT01010594|"~     It has been questioned whether patients with type 2 diabetes who are advised to restrict~     their fruit consumption to two or less pieces of fruits daily have better outcomes (HbA1c,~     body weight, fruit intake and serum lipids) after three months compared to patients with type~     2 diabetes who are advised to eat at least two pieces of fruits.~      To the investigators' knowledge, no randomized controlled trial has evaluated this.~      The investigators therefore perform a randomized controlled trial including 76 patients with~     type 2 diabetes to investigate this.~      The investigators' hypothesis is that:~      Type 2 diabetics who are advised to restrict their fruit consumption have the same Hba1c~     three months after an initially dietary treatment as type 2 diabetics who are advised not to~     restrict their fruit consumption.~   "
195037|NCT01010542|"~     The purpose of this research study is to evaluate the safety and tolerability of ILV-095 when~     it is given to individuals with moderate to severe chronic plaque psoriasis. Another purpose~     of the study is to observe how the drug enters the blood and tissues over time, how the body~     breaks down the drug and whether or not the body will develop an immune reaction~     (sensitivity) to the drug.~   "
195038|NCT01010529|"~     The purpose of this study is to determine the feasibility of a RCT evaluating the~     effectiveness of occupational therapy in Parkinson's disease.~   "
195039|NCT01010516|"~     Statin therapy does not fully eliminate the cardiovascular disease (CVD) risk associated with~     low high density lipoprotein-C (HDL-C) and high triglyceride levels. It is currently unknown~     what would be the best treatment option for patients with mixed hyperlipidemia who fail to~     meet their lipid targets with statin monotherapy at conventional does, i.e. high dose~     rosuvastatin or conventional statin dose plus micronized fenofibrate or conventional statin~     dose plus niacin/laropiprant. The aim of the present study is to compare the efficacy of~     high-dose rosuvastatin vs conventional statin dose plus micronized fenofibrate vs~     conventional statin dose plus extended-release niacin/laropiprant on lipid profile in~     patients with mixed hyperlipidemia. The primary efficacy endpoint will be changes in~     non-HDL-C levels at 6 months after treatment initiation.~   "
195040|NCT01010503|"~     This open-label, single-arm, non-randomized study will evaluate the adherence and persistence~     to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who~     have an inadequate clinical response to non-biologic DMARDs. Patients will receive~     tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with~     methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time~     of study treatment is 6 months. The target sample size is 20-50 patients.~   "
195041|NCT01010490|"~     To determine the differences in intra-operative complications, surgical duration, fluid~     usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial~     phacoemulsification (MCP) either with Torsional or longitudinal ultrasound during the surgery~     and at post-operative day 1, 1 month and 3 months.~   "
195042|NCT01010477|"~     This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine~     nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The~     objectives of this study are to determine the efficacy of NNS with behavioral intervention~     for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of~     subjects who receive NNS and behavioral intervention will be significantly greater than the~     quit rate of the control group who will receive the placebo spray plus same behavioral~     intervention. Quit rate is defined as the proportion of individuals who self report no~     tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10~     parts per million during these 4 weeks. The investigators will also assess abstinence rates~     at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been~     stopped. Since studies of this group suggest high relapse rates when treatments are~     discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the~     investigators will continue NNS treatment for a total of 20 weeks.~   "
195043|NCT01010464|"~     The purpose of this study is to determine whether an adhesion reduction plan, consisting of~     early adhesion prevention and application of a bioresorbable membrane is effective in~     reducing the severity of adhesions and the incidence of complications in managing the open~     abdomen in trauma and emergency general surgery.~   "
195044|NCT01010451|"~     There is a lack of evidence of the long-term successful outcomes of antimicrobial endodontic~     treatment for primary teeth. This study intended to evaluate (by survival analysis) the~     effectiveness of an antimicrobial pulpotomy (chloramphenicol, tetracycline, zinc~     oxide/eugenol) in primary molars compared to calcium hydroxide pulpectomy, testing the~     hypothesis that antimicrobial pulpotomy could be an alternative pulp therapy for primary~     teeth with pulp inflammation or necrosis.~   "
195045|NCT01010438|"~     The study is designed to compare the apnea event recognition capability of the Capnostream 20~     with investigational software to polysomnograph recordings scored by a trained analyst. The~     study will compare the apnea index score (AI) calculated by the Capnostream 20 algorithm~     based on capnography to that calculated by a trained analyst evaluating polysomnograph~     recordings.~      To this aim, subjects will be connected to EMBLA N7000 Polysomnograph, and to the Capnostream~     20, in order to monitor CO2 and SpO2 during routine overnight sleep studies.~      The Capnostream, using both its USB Data Port and Analog output port will simultaneously~     provide the monitored data both to a USB flash memory device and Polysomnograph for storage~     for future analysis.~      The data collected by the Polysomnograph including the Capnostream data will be analyzed by a~     trained expert for evaluation of apnea events obtained from both sources.~      In parallel, the Capnostream data as collected with the USB flash memory, will be downloaded~     onto a PC, and using the Oridion software algorithm designed for evaluating the data (to be~     implemented in the monitor when validated), the Apnea Index and Oxygen Desaturation Index~     will be calculated. The results of the Apnea Index scores calculated from the Polysomnograph~     and from the DUT will be compared.~      Based on the results, the study will then evaluate the ability of the~     Capnograph/Pulse-Oximeter as a tool for screening and assisting in the diagnosis of patients~     with obstructive sleep-apnea in the hospital environment, where it is being used as a~     ventilation monitor based on the demonstration of a high correlation with the gold standard~     in the sleep lab.~   "
195046|NCT01010425|"~     Double-blind, randomized, placebo and active controlled dose-ascending study to investigate~     safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).~   "
195060|NCT01010243|"~     To investigate the effect of an anti-inflammatory therapy consisting of lenalidomide in~     combination with pioglitazone, dexamethasone and metronomic low-dose chemotherapy with~     treosulfan on the response rate in patients with relapsed or refractory or progressive~     multiple myeloma(MM).~      Phase I: to determine the lenalidomide dse for the phase II part (5 mg or 10 mg or 15 mg) on~     the basis of dose-limiting toxicities (DLTs') in the first 4 weeks of treatment.~      Phase II: to determine~        -  response rate (primary objective)~        -  time to progression (TTP)~        -  time to partial response (TPR)~        -  overall survival (OS)~        -  quality of life~        -  tolerability and safety~   "
195729|NCT01001429|"~     The investigators would like to determine if using Dexmedetomidine alone or in a reduced dose~     can prevent or reduce the incidence of adverse effects, while providing adequate sedation,~     and respiratory stability as compared to propofol.~   "
195047|NCT01010412|"~     Hypothesis and Specific Aims:~      The investigators hypothesize that ultrasound (US) visualization is as effective as nerve~     stimulation (NS) for identification of peripheral nervous structures and may be associated~     with less trauma and patient discomfort. Specifically, the investigators believe that~     equivalent rates of surgical anesthesia are achievable with non-invasive ultrasonic needle~     guidance in comparison to needle guidance by intensity of motor fiber response to~     intermittent electrical nerve stimulation. Specifically, the number of needle sticks to~     identify the brachial plexus and total time to plexus sheath injection may be reduced while~     achieving similar efficacy rates. The investigators hypothesize that similar composite safety~     and efficacy endpoints but improved patient satisfaction and acceptance will favor US over NS~     guidance of nerve blocks indicated for surgery on the extremity surgery. However, the~     investigators believe that an economic assessment based upon capital hardware investment,~     operating room utilization, total block time, and pay for performance patient satisfaction~     metrics require examination prior to assimilation of new technology into clinical practice.~   "
195048|NCT01010399|"~     In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a~     switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result~     in 30% of patients achieving a reduction in fasting triglycerides < 200 mg /dL while~     maintaining virologic suppression.~   "
195049|NCT01010386|"~     Primary Aim~        -  Evaluate whether human embryo exposure to physiologic levels of oxygen during culture~          improves the percentage of women who deliver a baby following in vitro fertilization and~          embryo transfer.~      Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates~     the oxygen tension in the fallopian tube and uterus, improves live birth rate in clinical In~     Vitro Fertilization Embryo Transfer (IVF-ET).~      Secondary Aims~      Evaluate whether human embryo exposure to physiologic levels of oxygen during culture during~     in vitro fertilization and embryo transfer~        -  improves embryo cleavage~        -  improves clinical pregnancy rate~        -  reduces multiple pregnancy rate~        -  reduces miscarriage rate~      Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates~     the oxygen tension in the fallopian tube and uterus, improves embryo cleavage and clinical~     pregnancy rates and reduces miscarriage rates in clinical IVF-ET.~   "
195050|NCT01010373|"~     The purpose of this study is to determine whether addition of AS101 to the standard~     chemotherapy regimen is effective in the treatment of newly diagnosed elderly (≥60) AML~     patients and AML transformed myelodysplastic syndrome (MDS) patients.~   "
195051|NCT01010360|"~     Computer-aided image recognition will improve the technique of endoscopic ultrasound-celiac~     plexus block/celiac plexus neurolysis (EUS-CPB/CPN) and improved pain relief.~   "
195052|NCT01010347|"~     Background: distal radial buckle fractures are common injuries in children. the ideal~     immobilization technique is controversial. Few, retrospective studies have been conducted to~     evaluate bone healing after casting versus splinting. However, the impact of the~     immobilization technique on daily function and comfort has not been evaluated.~      Objective: To compare the impact on daily function, comfort and satisfaction of casting~     versus splinting in children with distal radial buckle fractures.~      Primary Hypothesis: Children with short arm casts to immobilize a distal radial buckle~     fracture will have a greater reduction in daily activities compared to those immobilized with~     a volar splint.~      Secondary Hypothesis: Children who are immobilized in a short arm cast will have less pain,~     less patient/parental satisfaction, more adverse effects, fewer follow-up visits, longer~     emergency department (ED) treatment time. Furthermore, we hypothesize that all fractures will~     have acceptable alignment/healing at the follow-up orthopaedic clinic evaluation.~   "
195053|NCT01010334|"~     Patient will choose to either receive the standard of care according to National~     Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be~     treated according to one arm of the protocol that they could not be enrolled on. The~     selection of the arm will be at physician discretion.~   "
195054|NCT01010321|"~     The investigators speculate that this tool may be used as an alternative and convenient~     non-invasive diagnostic of skin cancer.~   "
195055|NCT01010308|"~     The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of~     infancy.~      The secondary objective is to assess the feasibility of conducting a randomized controlled~     trial comparing nadolol with corticosteroids and propranolol.~   "
195056|NCT01010295|"~     Patients with mucosa-associated lymphoid tissue (MALT) lymphoma of the ocular adnexae (MLOA)~     will be eligible for treatment with doxycycline (part A: clinico-pathological study);~     patients with other types of ocular lymphoma, inflammatory lesions or those~     ineligible/unwilling for treatment with doxycycline can participate in the only pathologic~     study (part B).~   "
195057|NCT01010282|"~     This study will evaluate the safety, efficacy, and acceptability of two artificial tears~     compared to a currently available artificial tear in subjects with dry eye.~   "
195058|NCT01010269|"~     The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard~     Complete Knee System in Asian population in terms of early range of motion (ROM), clinical~     outcomes, and kinetic and kinematic characteristics in relation to healthy knees.~   "
195059|NCT01010256|"~     The purpose of this study is to evaluate the level of a specific protein (PTEN) in the cancer~     cells of chronic myelomonocytic leukemia (CMML) patients. This protein might be involved in~     the transformation from normal blood cells to leukemia cells. The PTEN protein has not been~     investigated in CMML specifically but it has been discovered in closely related cancers. If~     this study demonstrates an abnormality in this protein, future testing will be designed to~     evaluate the genetic abnormality that resulted in lack of the normal presence of this~     protein. The goal is that the results of this study will help to develop new drugs and~     strategies to treat the future patients with CMML by understanding the abnormality of the~     disease at the cellular and molecular levels. The results of this study can also be utilized~     by future studies to develop individualized treatment to patients who have abnormal levels of~     this protein.~   "
195313|NCT01006902|"~     The proposed project will document the degree of function decline, assess the relationship~     between function and cancer- related symptoms and evaluate relationships between function and~     quality of life. Participants are evaluated before therapy, after therapy and again 3 months~     post therapy to evaluate functional change. Knowledge gained will help us plan interventions~     around the time of cancer therapy to help older adults preserve or improve function.~   "
195061|NCT01010230|"~     Treatment for childhood cancer interferes with normal bone maturation such that maximal peak~     bone mass may never be attained by some survivors of childhood cancer. In childhood cancer~     survivors, a randomized trial evaluating the effectiveness of vitamin D and calcium~     supplementation among ALL survivors is currently underway; however, few other interventions~     have been offered for this at risk population. Recent evidence demonstrates that low~     magnitude; high frequency mechanical stimulation can improve bone quantity and quality,~     perhaps providing an alternative or adjunct to pharmacologic intervention in populations~     where additional medications are either contraindicated or not acceptable to the individuals~     at risk. This application proposes a prospective double blind randomized clinical trial of~     low magnitude, high frequency mechanical (LMHF) stimulation for childhood cancer survivors~     whose bone mineral density is one or more standard deviations below the mean for their age~     and gender.~   "
195062|NCT01010217|"~     The goal of this clinical research study is to learn about the safety of giving a stem cell~     transplant from a tissue-mismatched donor, followed by cyclophosphamide, to patients with~     certain types of blood disorders or blood cancers. Melphalan, thiotepa, and fludarabine will~     also be given before the transplant.~      Researchers will study the health status of these patients at 3 months after the transplant.~   "
195063|NCT01010204|"~     The investigators' hypothesis is that add-on varenicline will be effective (versus placebo)~     in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who~     are motivated to quit smoking within four weeks. This primary outcome will be assessed from~     randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the~     investigators also hypothesize that varenicline will prevent relapse in the subsequent~     12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the~     effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as~     well as its safety for use in stable bipolar patients when used as an add-on treatment for~     smoking cessation.~      The investigators plan to test these hypotheses by conducting a randomized,~     placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed~     with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up~     with them three months later to evaluate extended abstinence.~   "
195064|NCT01010191|"~     Irritable bowel syndrome patients will be given either placebo pill or no treatment for a~     period of 3 weeks.~   "
195065|NCT01010178|"~     Critical combination of various approved drugs in management for patients suffering with~     COPD.~   "
195066|NCT01010165|"~     Septic arthritis is a frequent, potentially disabling and/or life-threatening disease. To~     diagnose a septic arthritis is a complex procedure, first because of numerous differential~     diagnoses (such as crystal arthritis), second because of poor sensitivity of initial gram~     staining (for example after untimely antibiotic therapy).~      This protocol will use SELDI-TOF as a tool to analyse joint fluid of patients with various~     acute, polymorphonuclear-rich arthritis, as to determine specific and sensitive new~     biomarkers of a septic origin.~      Such biomarkers will allow rapid diagnosis of septic arthritis in the first hours of~     admission.~   "
195067|NCT01010152|"~     The objective of this study was to assess the comparative bioavailability of codeine from~     Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with~     codeine phosphate 30mg) under fasted conditions~   "
195068|NCT01010139|"~     The objective of this study designed to characterize the pharmacokinetics and comparative~     bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of~     60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.~   "
195069|NCT01010126|"~     This phase II trial studies how well temsirolimus and bevacizumab work in treating patients~     with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of~     cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may~     kill more tumor cells.~   "
195070|NCT01010113|"~     In this study the investigators want to evaluate the satiety of two infant formulas, one~     containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy~     measurement for the healthy development of an infant, will be assessed in both groups and~     compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non~     inferiority.~   "
195071|NCT01010100|"~     The purpose of the study is to determine if the administration of small doses of Acarbose can~     prevent or delay the appearance of Type 2 Diabetes Mellitus in a population of subjects with~     prediabetes.~   "
195072|NCT01010087|"~     Primary Objectives:~      The primary objective of the trial is to compare the antiviral efficacy of a 10 day course of~     standard (75 mg bid) and high-dose (225 mg bid) oseltamivir (or equivalent doses in~     mild-moderate renal failure) in the treatment of severe influenza infections.~      The hypothesis is that high dose oseltamivir will increase the proportion of patients with~     negative reverse transcriptase (RT)-PCR detection of influenza viral RNA (and viral culture,~     at selected sites) at Day 5 post-treatment.~      An important secondary objective of the trial, which reflects the main clinical objective, is~     to determine the difference in the numbers of ventilator days between the standard-dose and~     high-dose groups~   "
195086|NCT01009905|"~     This study is conducted in the United States of America (USA). The aim of this observational~     study is to collect data concerning the treatment outcomes and safety for children and adults~     who are prescribed Norditropin®. Specific objectives include: 1) developing models defining~     the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and~     treatment outcomes, accounting for independent factors such as age, gender and puberty and 2)~     determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and~     other factors before treatment to clinical outcomes.~   "
195087|NCT01009892|"~     The study was designed to assess the effect of food on the absorption of codeine from Roxane~     Laboratories' 60 mg Codeine Sulfate tablet~   "
195088|NCT01009879|"~     The purpose of the study is to determine the effects of TNF (tumor necrosis factor; a~     mediator of inflammation) on B cells in patients with rheumatoid arthritis. TNF and B cells~     are important in rheumatoid arthritis because they both appear to be involved in causing~     rheumatoid arthritis.~   "
195073|NCT01010074|"~     Parkinson's disease (PD) is a neurodegenerative disorder characterized by muscle rigidity,~     tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of~     physical movement. The primary symptoms are the results of decreased stimulation of the motor~     cortex arising from the basal ganglia normally caused by the insufficient formation and~     action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary~     symptoms may include high level cognitive dysfunction and subtle language problems. Included~     in the symptomatology experienced by patients with PD, visual abnormalities are not uncommon.~     Visual changes among patients with PD appear not only dynamic in nature, but differentially~     affected based on the course of the disease and, perhaps more importantly, its treatment.~     Parkinson's disease has significant ramifications not only in observation of irregularities~     in vision, but how vision interacts with entrainment of the circadian clock. The purpose of~     this study is to examine the relationship between PD and operation of a unique set of retinal~     cells known to regulate the circadian clock and sleep-wake cycles in human subjects.~   "
195074|NCT01010061|"~     This open-label, randomized, 3-arm study will evaluate the efficacy and safety of~     obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus~     chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic~     leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles~     of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and~     day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or~     rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil,~     or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for~     disease-progression and safety will be at least 5 years. In the US, this trial is~     sponsored/managed by Genentech.~   "
195075|NCT01010048|"~     The purpose of this study is to compare the stone clearance rate treated with different drugs~     after ESWL in urinary calculus,These drugs are often used in urinary calculus,such as~     progesterone,tamsulosin,propantheline Bromide and nifedipine.In these study the investigators~     want to investigate different effect of these drugs use to treat urinary calculus after ESWL.~   "
195076|NCT01010035|"~     The diabetic dyslipidemia is one of the most important risk factor in the development of~     coronary artery disease. The low density lipoprotein (LDL)-like nanoemulsions is being used~     to study the clearance of cholesteryl ester and free cholesterol from intravascular in~     patients with advanced coronary artery disease and it was shown a higher removal of free~     cholesterol and higher deposit in vases of this patients. The aim of this study is to analyze~     the plasma kinetics of both forms of cholesterol(free ad esterified) in type 2 diabetes~     patients without a previous history of cardiovascular disease.~   "
195077|NCT01010022|"~     The study shall evaluate the efficacy and safety of two different hydroxyethyl starch~     solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative~     therapy of hypovolemia and maintenance of circulating blood volume in patients undergoing~     orthopedic surgery. The primary efficacy endpoint will be the required volume of colloid~     solution infused from start until end of surgery. It is the aim of the clinical trial to~     demonstrate that comparable volumes of colloid solution are used between treatment groups.~   "
195078|NCT01010009|"~     Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by~     interacting with nitric oxide (NO). Research also shows that acute administration of~     metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance~     in young, healthy humans. The aim of this investigation was to determine if the consumption~     of resveratrol could modulate cerebral blood flow and if this in turn could influence~     cognitive performance by increasing access to blood borne metabolic fuel. Results showed that~     compared to placebo, after consuming 500mg pure trans-resveratrol, levels of total~     haemoglobin were significantly higher in the frontal cortex of young, healthy participants~     during cognitive task completion. Cognitive performance was not effected.~   "
195079|NCT01009996|"~     KISSING DEBBIE's aim at assessing angiographic and clinical outcomes of provisional treatment~     of coronary bifurca6on lesions according to TAP sten6ng with BMS and final kissing DEB~   "
195080|NCT01009983|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Other find tumor cells and~     help kill them or carry tumor-killing substances to them. Giving panitumumab together with~     paclitaxel and carboplatin may be a better way to block tumor growth.~      PURPOSE: This phase II trial is studying the side effects and how well paclitaxel and~     carboplatin together with panitumumab works in treating patients with metastatic triple~     negative breast cancer.~   "
195081|NCT01009970|"~     This is a multicenter study phase II, open-label for cardiopathic patients affected by~     Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to~     study the feasibility of R-COMP in this cohort of patients.~   "
195082|NCT01009957|"~     The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down~     the progression of CKD in ADPKD patients.~   "
195083|NCT01009944|"~     The purpose of this study is to develop an approach to provide personalized medicine to~     individuals who have hypertension (high blood pressure). The investigators plan to use~     people's genetic characteristics (traits) to determine what medication they should use to~     lower their blood pressure most effectively. The investigators will give individuals one of~     two medications to treat hypertension (lisinopril or atenolol). The investigators believe~     that depending on the individuals genetic background one medication will work better in~     lowering their blood pressure.~   "
195084|NCT01009931|"~     This phase II trial is studying the side effects and how well giving tetradecanoylphorbol~     acetate together with dexamethasone and choline magnesium trisalicylate works in treating~     patients with relapsed or refractory acute myeloid leukemia.~   "
195085|NCT01009918|"~     RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is~     not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing~     side effects caused by trastuzumab.~      PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work~     compared with a placebo in reducing side effects in patients with HER2-positive breast cancer~     receiving trastuzumab.~   "
195089|NCT01009866|"~     Purpose of the study:~      Primary Objective: Determine the maximum tolerated dose (MTD) and dose limiting toxicity~     (DLT) of MR1-1KDEL when delivered intracerebrally by convection-enhanced delivery (CED) in~     patients with supratentorial malignant brain tumors.~      Secondary Objective: Document any radiographic responses associated with intracerebral CED of~     MR1-1KDEL.~      Hypothesis: The investigators believe that MR1-1KDEL will be an effective anti-tumor agent~     for patients with supratentorial malignant brain tumors when delivered by CED.~      Design & procedures: This protocol is designed primarily to determine the MTD and DLT of a~     novel, tumor-specific immunotoxin, MR1-1KDEL. MR1-1KDEL will be delivered intracerebrally by~     CED using 2 intracerebral catheters with at least one catheter placed within the enhancing~     portion of the tumor. 124I-labeled albumin will be co-infused with gadolinium and PET and MRI~     images will be obtained at the conclusion of the infusion to monitor volume of drug~     distribution and leakage into the CSF space.~      Based on preclinical toxicity studies, the starting total drug dose will be 0.5μg (500ng)~     which represents 1/20th of the MTD in rats. The infusion flow rate will be fixed at 0.5 mL/h~     from each of two to four catheters. A total of 144 mLs of drug solution will be delivered~     over 72 hours. MR1-1KDEL dose escalation will be accomplished by increasing drug~     concentration allowing flow rate and infusion volume to remain unchanged. Drug dose will be~     doubled in successive cohorts so long as DLTs are not observed as follows: 25 ng/mL (2.4~     μg)(starting dose); 50ng/mL (4.8μg); 100 ng/mL (9.6μg); 200ng/mL (19.2μg); 400 ng/mL~     (38.4μg); 800 ng/mL (76.8μg); and 1600 ng/mL (153.6μg). At least 3 patients will be enrolled~     in each cohort. All patients in a given cohort will be observed for at least two weeks~     following infusion of the study drug before patients in the next cohort are treated. If no~     patients in a given cohort experience a DLT, the dose will be escalated in the next cohort.~     If 1 out of 3 patients in a given cohort experience DLT, 3 additional patients will be~     entered in that cohort. If 2 patients develop a DLT in any cohort of 3 or 6 patients, the~     previous dose will be declared the MTD. Patients will be followed at 1, 3, 6, 9, 12 month~     intervals for toxicity and adverse events, radiographic response, and survival. Patients will~     be off study when progressive disease is documented.~      Risk/benefit assessment: This is an experimental study and unforeseeable or unexpected risks~     may be involved.~   "
195090|NCT01009853|"~     Study to characterize the steady-state pharmacokinetics of codeine and its metabolites~     morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral~     administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15~     mg Q4H x 5 days.~   "
195091|NCT01009840|"~     Study for the outcome and safety of individualized busulfan dosing with bortezomib for~     patients preparing for a second stem cell transplant to treat multiple myeloma.~   "
195092|NCT01009827|"~     This study will collect information on health status and risk behaviors, as well as basic~     demographic and biomedical information for a group of HIV positive adolescents receiving care~     at the ATN sites.~   "
195093|NCT01009814|"~     Research Hypothesis: Administration of BMS-663068, a prodrug for HIV attachment inhibitor~     BMS-626529, will result in a mean decrease of at least 1 log10 in HIV RNA at Day 9 following~     8 days of therapy in at least one dosing regimen that is safe and well tolerated in Clade B~     HIV-1 infected subjects.~   "
195094|NCT01009801|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking~     the blood flow to the tumor. Everolimus may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet~     known whether transarterial chemoembolization with doxorubicin is more effective when given~     alone or when given together with everolimus in treating patients with liver cancer.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     everolimus when given together with transarterial chemoembolization with doxorubicin and to~     see how well it works compared with giving transarterial chemoembolization with doxorubicin~     alone in treating patients with liver cancer.~   "
195095|NCT01009788|"~     The purpose of this research study is to find out if the combination of ABT-888 and~     temozolomide is safe and effective in treating patients with metastatic breast cancer.~     ABT-888 works by obstructing a DNA enzyme called poly (ADP-ribose) polymerase (PARP) which~     helps repair cancer cells damaged by chemotherapy. By blocking the PARP enzyme, the cancer~     cells are unable to repair themselves and as a result die. The other drug in this study is~     temozolomide. Temozolomide is designed to damage DNA in order to prevent cancer cells from~     reproducing. Because PARP inhibitors, such as ABT-888, prevent cancer cells from repairing~     their own DNA, they enhance the potential of chemotherapy therapy like temozolomide to induce~     cell death. The combination of ABT-888 and temozolomide has been used in a clinical trial for~     treatment of other cancers and information for this research study suggests that the~     combination may help to inhibit growth in breast cancer.~      ONLY THE EXPANSION COHORT BELOW IS RECRUITING:~      BRCA CARRIER EXPANSION COHORT: The purpose of the expansion cohort is to further evaluate the~     activity and safety of this combination in BRCA mutation carriers with metastatic breast~     cancer.~   "
195096|NCT01009775|"~     The purpose of the study is to evaluate survival, response rate, safety and tolerability of~     YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and Stage~     IV melanoma.~   "
195097|NCT01009762|"~     Treatment: Immunization with a peptide-mix of 17 Clusters of Differentiation number 8 (CD8) T~     cell minimal epitopes and 3 Clusters of Differentiation number 4 (CD4) T cell epitopes and a~     new adjuvant (CAF01). The vaccine should induce cellular immunity against human~     immuno-deficiency virus type-1 (HIV-1).~      Target group: Untreated healthy individuals with chronic HIV-1 infection who are not in~     antiretroviral treatment.~      Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine.~      The secondary purpose is to evaluate the clinical effect of the vaccination treatment as~     measured by induction of new T cell immunity, lowering of HIV-1 ribonucleic acid (RNA) viral~     load in plasma, and improvement in the patient CD4 lymphocyte blood counts.~      Design: The experiment is designed as a single-blinded, placebo-controlled phase 1 clinical~     trial in HIV-1 infected individuals in Denmark.~      Numbers of individuals: 20 fully evaluable HIV-1-infected patients should enter the study (15~     vaccine treated and 5 placebo(saline) treated controls).~      The hypothesis is that a redirection of cytotoxic T lymphocyte (CTL) immunity to selected~     relatively immune silent (subdominant) but conserved CTL targets on multiple sites in HIV-1~     could provide a better immune control of the virus replication. This could result in lowering~     of viral load thereby prolonging the time to antiretroviral therapy.~   "
195117|NCT01009502|"~     Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      This was originally designed as a phase I/II trial studying the side effects of sodium~     stibogluconate and how well it works in treating patients with myelodysplastic syndromes.~     Unfortunately, due to funding issues, the phase II portion was never conducted.~   "
195324|NCT01006746|"~     Describe the mutual influences between trainings realized in implantation centers,~     medico-technical knowledges, technical implementation, perception, fears and appreciation~     felt by the patients during Home Monitoring implementation.~   "
195098|NCT01009749|"~     This is a two-phase study, consisting of the following plan:~      Phase I - This is a pre-test of the feasibility and acceptability of the beta version of a~     computer-delivered intervention, Motivational Enhancement System for Adherence (MESA), as~     well as the control intervention Motivational Enhancement System for Health (MESH) at three~     selected AMTUs. Following analysis of the responses in Phase I and further modification of~     the intervention, Phase II will be initiated.~      Phase II - This is a pilot, randomized, controlled trial (RCT) testing a two-session~     computer-delivered intervention, MESA, designed to increase motivation for adherence to~     Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin~     medications, as well as an attention control, MESH, matched for dose and delivery format.~     Phase II is open to all 15 AMTUs.~   "
195099|NCT01009736|"~     RATIONALE: Tomato-soy juice may slow the growth of tumor cells. Studying samples of blood and~     tissue from patients with prostate cancer in the laboratory may help doctors identify~     biomarkers related to cancer. It may also help doctors understand the effect of tomato-soy~     juice on biomarkers.~      PURPOSE: This phase I/II trial is studying the side effects of tomato-soy juice and its~     effect on biomarkers in patients with prostate cancer undergoing prostatectomy.~   "
195100|NCT01009723|"~     This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women.~     The biological specimens will be used to determine the predictive power of biochemical~     markers routinely used in Down syndrome screening in the assessment of patient's risk of~     preterm delivery.~   "
195101|NCT01009710|"~     A specific group of neurons in the brain produces hypocretin, a peptide which has been~     established as an important regulator of sleep and wakefulness. Activation of these neurons~     (increased hypocretin) stabilizes wakefulness; impairing or blocking these neurons (decreased~     hypocretin) promotes sleep. Evidence suggests that these neurons may be involved in the~     hypnotic properties of several anesthetics, and play a role in the induction and emergence~     from anesthesia. In humans there is a considerable inter-individual variability in hypocretin~     levels. This study aims to investigate how hypocretin levels affect the anesthetic care and~     recovery of patients undergoing elective hip surgery.~   "
195102|NCT01009697|"~     The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg,~     30 mg, and 60 mg codeine sulfate tablets under fasted conditions~   "
195103|NCT01009684|"~     The primary objective of the study is to assess the risks of short and long-term use of~     estradiol valerate/dienogest (EV/DNG) and of established oral contraceptives (OCs) in a study~     population that is representative for the actual users of the individual preparations. This~     includes an estimate of the absolute risk of rare serious adverse outcomes.~   "
195104|NCT01009671|"~     The primary objective of this study, comparing ART 44 to ART 50, will be the evaluation of~     digestive tolerability (and in particular of diarrhoea).~   "
195105|NCT01009658|"~     The purpose of this study is to clarify the physiological function of sodium glutamate by~     measuring its effect on upper GI motility ( gastric emptying).~   "
195106|NCT01009645|"~     The purpose of this study is to evaluate whether message design of educational materials~     increases vaccination rates among participants.~   "
195107|NCT01009632|"~     The purpose of this study is to explore quantitatively the hypothesis that resonant voice,~     may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human~     laryngeal secretions and secondarily, clinical tests.~   "
195108|NCT01009619|"~     Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans~     Syndrome after lung transplantation.~   "
195109|NCT01009606|"~     The bereavement generated by the loss of a family member can induce pathological situations:~     depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid~     factors can be influenced by the death circumstances and in particular by the possibility~     given to the family to attend the medical management of the patient. This clinical trial aims~     to evaluate the psychological consequences of bereavement on the relatives according to the~     possibility of witnessing the cardiopulmonary resuscitation of a family member. This~     possibility lies within the scope of a strategy of global management of the relatives.~   "
195110|NCT01009593|"~     The primary objective of this study is to assess the overall survival (OS) of oral linifanib~     given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per~     standard of care in subjects with advanced or metastatic HCC.~   "
195111|NCT01009580|"~     This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to~     compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects~     with type 2 diabetes.~   "
195112|NCT01009567|"~     The purpose of this study is to investigate the efficacy and safety of cabergoline in~     prevention of ovarian hyperstimulation syndrome versus albumin in ART program.~   "
195113|NCT01009554|"~     This study is 8 weeks long. People participating in this study will be asked to brush their~     teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse~     two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked~     at by a dentist. The dentist will look at the mouth to make sure the mouthwash does not~     irritate the mouth. The dentist will also look at the color of the teeth and amount of stain~     on the front teeth.~   "
195114|NCT01009541|"~     The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of~     three pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three~     pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate~     release capsule and 3) evaluate the safety and tolerability of multiple doses of three~     pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule.~   "
195115|NCT01009528|"~     The aim of this study is to determine whether electronic feedback to general practitioners on~     quality of Type 2-Diabetes care increases the quality of care measured on process and outcome~     measures contained in the national guidelines. Effect evaluation will be performed using a~     mixed method design.~   "
195116|NCT01009515|"~     The number of melanoma cases has been steadily increasing over the past few decades. For many~     patients with metastatic melanoma, there are no effective therapies. The goal of this study~     is to determine whether a combination drug treatment of carboplatin, paclitaxel and~     temozolomide is effective in the treatment of metastatic or recurrent melanoma.~   "
195118|NCT01009476|"~     The main objective of this non-interventional study was to document the long-term application~     of galantamine and nootropics (memory enhancing drugs) over a period of 1 year under~     conditions of daily routine. There were no predefined specifications of diagnostic and~     therapeutic measures. The decision for treatment with either galantamine or a nootropic had~     to be made by the treating physician prior to the start of documentation. The following~     measures were to be documented: safety, tolerability, dementia-associated symptoms (unstable~     walking, vertigo, awakening at night, shouting/screaming at night, perambulating at night,~     aggressiveness, agitation, apathy/social retreat, delusions, hallucinations, behavior that~     poses a risk to self or others, and daytime tiredness), frequency of admissions to nursing~     homes or nursing services, global functional level, caregiver's burden, and time spent on~     caregiving. Furthermore, this study aimed to gather knowledge on the differentiated use of~     the two treatment strategies considering the specific diagnosis of dementia (e.g. Alzheimer's~     disease only or mixed dementia, i.e. Alzheimer's disease and cerebrovascular disease) and~     risk profiles.~   "
195119|NCT01009463|"~     The Purpose of this study is to assess the efficacy and safety of three strengths of the~     FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)~   "
195120|NCT01009450|"~     This study included group (A) (60 patients with liver cirrhosis and complaining of gall~     stone) in whom LC was done using traditional method (TM) by clipping both cystic duct and~     artery and dissection of gall bladder from liver bed by diathermy, and group (B) (60 patients~     with liver cirrhosis and complaining of gall stone) LC was done using harmonic scalpel (HS)~     closure and division of both cystic duct, artery and dissection of gall bladder from liver~     bed by harmonic scalpel. The Intraoperative and postoperative parameters were collected~     included duration of operation, postoperative pain, and complications.~   "
195121|NCT01009437|"~     RATIONALE: Ritonavir may stop the growth of tumor cells by blocking some of the enzymes~     needed for cancer cell growth. Studying samples of blood and tissue from patients with breast~     cancer in the laboratory may help doctors learn more about the effects of ritonavir on~     biomarkers involved in breast cancer growth.~      PURPOSE: This phase I/II trial is studying the best dose of ritonavir and its effects on~     biomarkers in women undergoing surgery for newly diagnosed breast cancer.~   "
195122|NCT01009424|"~     This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of~     RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic~     Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled~     doses of R7103, as compared with placebo. The target sample size is approximately 30~     individuals.~   "
195123|NCT01009411|"~     Objective of the study: to obtain new data on the dynamics of the labor process, cervix~     dilatation and head station on the labor process and to develop a new progress indices.~      Background: the best method used today to supervise the labor process is to follow cervix~     dilatation and head station. Today, the physician or the midwife use manual examination to~     estimate cervix dilatation and head station. This examination is perform many times in a~     normal labor process, and even more if there is any delay. The information from these~     examinations is inaccurate and non-continuous. In case of delay in the labor process, the~     delay will diagnosed late, because the frequency of the manual examination is about once an~     hour.~      With the assistance of the BirthTrack device we can get continuous data on the labor process~     and get indices to estimate the labor process progress without the use of vaginal (manual)~     examination.~      40 women in an active labor will take part in the study.~      Method: by connecting sensors to the woman abdomen, to the cervix and to the baby head we~     follow the cervix dilatation and the fetus head station.~   "
195124|NCT01009398|"~     Thoracic operations are known to be painful and requiring an adequate postoperative pain~     therapy. A well documented technique to achieve postoperative analgesia is the use of~     paravertebral catheters. Theoretically the thoracic paravertebral block results in an~     unilateral thoracic anaesthesia. However, in the daily clinical practice it remains unclear~     whether catheters are placed correctly into the paravertebral region. The investigators'~     experiences with paravertebral catheters suggest that there may be many displacements of~     catheters since the pain control is reduced compared to epidural analgesia.~      The aim of this prospective observational clinical trial is to postoperatively evaluate the~     exact location of paravertebral catheter placed for thoracoscopic interventions by using the~     classical land-mark puncture technique. After radiological detection of the catheter~     position, the spread and distribution of contrast dye injected through the catheters will be~     evaluated.~   "
195125|NCT01009385|"~     Cervical epidural steroid injections~        -  The hanging drop (HD) technique is commonly used for identifying the cervical epidural~          space.~        -  The hanging drop (HD) technique is using the negative pressure in the epidural space.~        -  The subject of debate whether the epidural space exhibits negative pressure.~        -  In a previous study, EP might be influenced by body position~        -  No report or peer-reviewed literature to demonstrate the cervical epidural pressure~          (CEP) now.~      The hypothesis of this study~        -  There is a difference in the cervical epidural pressure between in the prone and sitting~          positions~        -  To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and~          compared in the two groups.~        -  Using a closed pressure measurement system~        -  Under fluoroscopic guidance.~   "
195126|NCT01009372|"~     Many people spanning from air traffic controllers to simple production line workers share~     regular compulsive breaks to revert fatigue whilst they work. This is uncommon for medical~     operators - a macho image is still as prevalent in real life as it is in countless TV series.~      We report on the first clinical trial on regular intraoperative breaks. For one time we~     turned our scientific curiosity to ourselves. This included the intraoperative collection of~     body fluids and required transparency which was not easy to obtain. It was rewarded with~     striking results: Regular intraoperative breaks lowered significantly the operators stress~     hormone levels, improved error-performance testing results and musculoskeletal fatigue~     scores. Subjectively the breaks enhanced the practitioners satisfaction.~      Surprisingly the operator's breaks were not at the cost of the patient: because the did not~     prolong the overall operation time at all and - in our setting- they significantly increased~     of cardiac output and urine production.~   "
195127|NCT01009359|"~     PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of~     neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and~     radiation dosimetry in healthy volunteer.~   "
195128|NCT01009346|"~     1. Phase I: To estimate the Maximum Tolerated Dose (MTD) of RAD001 in combination with~          cetuximab and cisplatin for treatment of metastatic squamous cell cancer of the head and~          neck (SCCHN).~        2. Phase II: To estimate the progression free survival (PFS) of RAD001 at MTD in~          combination with weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in~          patients with recurrent or metastatic SCCHN,~      Secondary Objectives~        1. To estimate the complete and partial response rate of RAD001 at MTD in combination with~          weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in patients with~          recurrent or metastatic SCCHN,~        2. To explore if the clinical activity of this regimen correlates with markers of the~          EGF-R/mTOR pathway in tumor tissue by serial sampling of tumor.~        3. To explore the role of FDG PET imaging as an early indicator of response to this~          combination.~   "
195129|NCT01009333|"~     This study assessed the effect of different InterStim rate settings on voiding diary~     outcomes. Specifically, the study evaluated how 3 different rate settings affected the number~     of urinary incontinent episodes per day collected through a voiding diary. The study also~     evaluated how the 3 different rate settings affected other voiding diary measures including~     number of voids per day, degree of urgency before each void, number of pads used per day, and~     number of fecal incontinent episodes, questionnaires, and adverse events.~   "
195130|NCT01009320|"~     Magnetic fields may interfere with the function of cardiac pacemakers. A magnetic drape to~     hold surgical instruments is widely used in surgery. The use of this drape on pacemaker~     patients has not yet been tested. Our objective is to conduct a clinical study to evaluate~     the potential interference of the surgical magnetic drape on patients with cardiac~     pacemakers. We are testing the magnetic drape on forty patients in the pacemaker clinic. The~     totality of the drape is applied over the pacemaker and depending on the result, the drape is~     either folded in two over the pacemaker or the magnets are applied individually up to the~     totality of the drape, 70 magnets. Thereafter, the drape is pulled in increments of 3 cm~     caudally until the interference is ceased. Results are in process as we are presently~     actively recruiting.~   "
195131|NCT01009307|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at blood and cheek cell samples from patients with~     glioma.~   "
195132|NCT01009294|"~     Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It~     is caused by a mutation in the gene for dystrophin, a protein that is important for~     maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility~     that leads to weakness and loss of walking ability during childhood and teenage years. A~     specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of~     DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally~     delivered, investigational drug that has the potential to overcome the effects of the~     nonsense mutation. This study is a Phase 2a trial that will enroll boys with nonsense~     mutation DMD/BMD who have lost independent mobility due to the disease. This study will~     evaluate the safety and tolerability of ataluren (PTC124) and will also evaluate efficacy~     outcomes in this patient population.~   "
195133|NCT01009281|"~     This study will assess the safety and tolerability of AIN457 in patients with moderate to~     severe Crohn's disease who already participated and completed the core trial CAIN457A2202.~   "
195134|NCT01009268|"~     The investigators' aim is to assess the effect of a model of preoperative as well as early~     postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a~     single-blind randomised study.~      The investigators' main hypothesis is that an orthogeriatric service may improve long-time~     cognitive outcome.~   "
195135|NCT01009255|"~     This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512~     compared to placebo in patients with mild to moderate Alzheimer's disease~   "
195136|NCT01009242|"~     The primary objectives are to determine the relationship between blood levels of CDP6038 and~     suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV)~     infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of~     CDP6038 will also be evaluated.~   "
195137|NCT01009229|"~     Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for~     donation according to official guidelines. An assessment of salt sensitivity, 11 beta HSD~     activity, 24 hour blood pressure, urine collection and physical exam will be performed prior~     nephrectomy and 14, 52, 156, 208 days post-nephrectomy.~   "
195138|NCT01009216|"~     The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics~     and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male~     volunteers.~   "
195139|NCT01009203|"~     The primary hypothesis of this study is that the addition of mammalian target of rapamycin~     (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result~     in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN),~     consistent with preclinical xenograft data. Patients will be treated with the combination of~     temsirolimus and erlotinib, at the previously established Maximal Tolerated Dose (MTD). The~     primary signal of efficacy will be progression free survival (PFS), anticipating that PFS~     will be prolonged compared to historical PFS in SCCHN patients treated with erlotinib or~     cetuximab monotherapy.~   "
195140|NCT01009190|"~     Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy~     in adult patients with advanced solid tumors~   "
195141|NCT01009177|"~     The study is designed as a multicenter, double blind, parallel-group, placebo-controlled,~     randomized, event driven Phase II study of DTIC with or without bosentan as first-line~     treatment in patients with stage IV melanoma.~   "
195167|NCT01008826|"~     The study hypothesis tested is that broccoli sprouts are effective at altering the urinary~     levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant~     phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study~     will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or~     sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the~     biomarkers.~   "
195730|NCT01001403|"~     This study intends to see the effect of nafamostat on the attenuation of postreperfusion~     syndrome (PRS) that frequently occurs during liver transplantation.~   "
195142|NCT01009151|"~     The proposed pilot project is aimed at assessing the feasibility, acceptability and impact of~     a web-based home tele-monitoring system among congestive heart failure patients at the~     University of Michigan Health System. The intervention consists of daily reporting via the~     internet on health parameters, such as weight, blood pressure, heart rate and heart failure~     symptoms. In addition to symptom and data reporting, the system provides links to educational~     material on heart failure and reminders for self-care measures. It is designed as an~     inexpensive, user-friendly, and clinically effective system.~      Each patient will be provided with a unique name and password, and will be instructed on how~     to use the self-management website.~      The proposed home monitoring system study holds the potential to improve the lives of heart~     failure patients treated at the University of Michigan Health System by empowering them to~     participate actively in their care and to reduce the risk of hospitalization. As heart~     failure represents the most common hospital diagnosis related group (DRG)among the elderly,~     this study offers a significant public health benefit.~   "
195143|NCT01009138|"~     This work is supported by the Kompetenznetz Diabetes mellitus (Competence Network for~     Diabetes mellitus) funded by the Federal Ministry of Education and Research (FKZ 01GI0809).~      Approximately one third of diabetic patients has elevated depressive symptoms. The majority~     of these patients are suffering from a subthreshold depression. In spite of the fact that~     subthreshold depression has an equivalent negative impact on the prognosis of diabetes as~     clinical depression, there is no specific intervention tool. The main objective of this~     project is to develop a diabetes specific cognitive behavioural treatment (DS-CBT) for~     diabetic patients with subthreshold depression. In a randomized trail DS-CBT is compared to~     standard diabetes education. A total of 188 diabetic patients will be recruited and randomly~     assigned to the two treatment conditions. The expected main outcome is the reduction of~     subthreshold depression under DS-CBT in a 12 month follow up. Secondary variables are~     improvement of glycaemic control, quality of life, diabetes self-management as well as~     reduction of health care costs and modification of inflammatory parameters.~   "
195144|NCT01009125|"~     This is a mailed survey to persons who served as living kidney donors at Saint Barnabas~     Medical Center. The experimental component of this study (the clinical trial) is a randomized~     trial of two monetary incentives for the living kidney donors invited to participate in the~     study. Kidney donors will be randomized to receive one of two incentives in the mailed survey~     packet: $2 cash vs. $5 cash. The main outcome measure is the response rate to the survey.~   "
195145|NCT01009112|"~     Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD),~     results in numerous negative consequences for patients, families, and society. Some of the~     most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and~     insomnia. This study will examine whether treatments specifically targeted at those sleep~     disorders can improve clinical outcomes and increase health-related quality of life in~     individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares~     and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of~     life.~   "
195146|NCT01009099|"~     This study will compare the effects of exercise training and breathing retraining (using~     metronome tones) to exercise training only. Exercise training lasts 12 weeks.~   "
195147|NCT01009086|"~     The purpose of this study is to evaluate the effectiveness (improvement of signs and~     symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.~   "
195148|NCT01009073|"~     This is a three arm study to determine the maximum tolerated dose (MTD) of ABT-263 when~     administered in combination with erlotinib (Arm A), to determine the maximum tolerated dose~     (MTD) of ABT-263 when administered in combination with irinotecan (Arm B), and to evaluate~     safety of ABT-263 monotherapy (Arm C).~   "
195149|NCT01009060|"~     This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512~     compared to placebo in patients with schizophrenia~   "
195150|NCT01009047|"~     The purpose of this study is to evaluate the efficacy and safety of extended-release (ER)~     paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having~     symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of~     emotional instability, detachment from reality, often with delusions and hallucinations~     [imagining things], and withdrawal into the self) .~   "
195151|NCT01009034|"~     The objective of this study is to determine if concentrations of maraviroc in semen exceed~     the 50% and 95% inhibitory concentrations of HIV during the dose interval.~      The secondary objective is to determine the extent of maraviroc penetration into semen by~     obtaining semen to plasma ratios across the dosing interval, to determine the area under the~     concentration time curve of maraviroc in semen, and to determine the variability in the~     penetration of maraviroc into the seminal compartment over the maraviroc dosing period.~   "
195152|NCT01009021|"~     The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac~     in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation.~      Two groups of patients were followed and the effect of the treatment (diclofenac plus laser)~     was compared to placebo (placebo plus laser). Pain associated with treatment was recorded~     using a Visual Analog Scale 15 minutes after the procedure.~   "
195153|NCT01009008|"~     The purpose of this study is to determine whether a patient controlled tissue expander can~     improve the results and patient experience in breast reconstruction. The study hypothesis is~     that patient controlled expansion will lead to rapid and more comfortable outcomes than~     historical precedents.~   "
195154|NCT01008995|"~     The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of~     ustekinumab in the treatment of patients with moderate to severe psoriasis in China.~   "
195168|NCT01008813|"~     A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The~     purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French~     National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with~     or without adjuvant, in HIV-infected patients after one or two injections.~   "
195169|NCT01008800|"~     This research is being done to test the effectiveness of two treatments aimed at increasing~     language and social skills in children with autism spectrum disorder. If children show~     improvement in these treatments, we hope that the availability of public services for~     minority and low income families will be increased. Minority and low income families with~     children between 22 and 33 months of age with Autism Spectrum Disorders may join.~   "
195155|NCT01008982|"~     Background and rationale Sjögren's syndrome (SS) is a systemic autoimmune disease~     characterized by chronic inflammation of salivary and lachrymal glands, frequently~     accompanied by systemic symptoms. The presence of various autoantibodies such as rheumatoid~     factor (RF) and anti-SSA/SSB antibodies, as well as hypergammaglobulinemia, reflect B cell~     hyperactivity. About five percent of patients with SS develop malignant B cell lymphoma,~     usually of the mucosa-associated lymphoid tissue (MALT) type and most frequently located in~     the major salivary glands. Currently, there is a lack of evidence-based intervention therapy~     which may influence SS-related chronic inflammation and lymphoproliferation. B cells are~     involved in the pathogenesis of SS, and B cell downregulation may lead to a decrease of~     disease activity. Patients with more residual exocrine gland function, e.g., those with SS of~     shorter duration, might better benefit from systemic therapy, as reported in a preliminary~     study on the efficacy of B-cell depletion in SS.This study will examine the effect of the~     drug Belimumab in patients with SS. Patients aged more than 18 years with SS may be eligible~     for this study. Candidates will be screened with complete history and physical examination,~     chest x-rays, and oral and eye examinations.~   "
195156|NCT01008969|"~     The purpose of this study is to develop a practice procedure for lymphatic drainage mapping~     with the intent of providing a new tool that could potentially be used for radiation~     treatment planning. High-risk prostate cancer patients who are scheduled to be treated with~     intensity-modulated radiotherapy (IMRT) may be eligible to enroll in this study. 99mTc-sulfur~     nanocolloid, a radiopharmaceutical (tracer) will be injected by a urologist using~     transrectal ultrasound guidance (TRUS)at the UCSF Urology Clinic. Participants will then~     undergo SPECT/CT imaging at the UCSF Nuclear Medicine Clinic. This study will evaluate the~     feasibility of transporting patients to the Nuclear Medicine Clinic for imaging within 1-3~     hours after administration of 99mTc-sulfur nanocolloid.~   "
195157|NCT01008956|"~     This study is designed to characterize the safety and immunogenicity of a' pandemic influenza~     (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.~   "
195158|NCT01008943|"~     The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety~     and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle~     Derived Cells for treatment of Stress Urinary Incontinence.~   "
195159|NCT01008930|"~     The goal of this clinical research study is to learn if using the PEMFlex Solo II, a~     high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected~     to have cancer will give researchers the same or better information about the disease~     compared to the images taken with a routine PET/CT.~      Researchers will compare the images taken using the PEMFlex Solo II to the images taken~     during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s),~     magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within~     the last 30 days or may have in the next 30 days.~   "
195160|NCT01008917|"~     This is a Phase I study, which means that the goal is to see if the combination of~     Temsirolimus and Sorafenib is safe in patients with Hepatocellular Carcinoma. Sorafenib is a~     standard treatment for Hepatocellular Carcinoma. Temsirolimus is used to treat cancer in the~     kidneys. It is hoped that the addition of Temsirolimus will make Sorafenib more effective~     against Advanced Hepatocellular Carcinoma, however this can not be guaranteed. The addition~     of Temsirolimus to Sorafenib is not an FDA approved treatment for Advanced Hepatocellular~     cancer.~   "
195161|NCT01008904|"~     RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.~      PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot~     flashes in menopausal women with cancer.~   "
195162|NCT01008891|"~     Study Objective: To demonstrate equivalent clinical and radiologic outcomes as gold~     standard (ABG) in a representative clinical model (foot and ankle fusions)~      Study Hypothesis: Augment™ Injectable is an equivalent bone grafting substitute to autologous~     bone graft in applications as shown by superiority analysis for safety and non-inferiority~     analysis for effectiveness~      Study Rationale: Evaluate a fully synthetic bone graft material to facilitate fusion in~     conditions or injuries requiring bone graft in a representative clinical fusion model and~     thus the opportunity to provide equivalent union rates as ABG without necessitating an~     additional invasive procedure to harvest the graft~   "
195163|NCT01008878|"~     This study is a randomized, controlled and opened trial designed to compare the effects of an~     interdisciplinary moderate-intensity lifestyle modification program vs. conventional~     treatment by primary care physicians.~      We want to show the benefits of coherent interdisciplinary care in the obesity clinic of CHUS~     (Centre Hospitalier Universitaire de Sherbrooke) in comparison to the conventional treatment~     in order to:~        -  Improve subjects' characteristic features of metabolic syndrome: weight, waist~          circumference, fatty mass, plasma lipid profile, blood pressure, fasting glycaemia, and~          HbA1c;~        -  Improve our patients' nutritive practices;~        -  Decrease our patients' sedentary lifestyle;~        -  Improve our patients' motivation to lose weight, and to improve their quality of life;~          We also wish to define predictors of answer in order to better select the patients if~          necessary, and evaluate the costs incurred by the health system.~   "
195164|NCT01008865|"~     This is a prospective, randomized study of two types of continent ileal neobladder~     construction in patients undergoing cystectomy for primary bladder cancer. Patients will be~     randomly assigned to have either a T-pouch or a Studer pouch constructed at the time of their~     surgery. They will be followed long-term to determine the relative advantages and~     disadvantages of the two types of diversion. The investigators' hypothesis is that the~     inclusion of an antireflux mechanism in the T-pouch will result in significantly fewer~     episodes of symptomatic urinary tract infection, and will have a lower incidence of upper~     tract dilation and loss of renal function over the long term.~   "
195165|NCT01008852|"~     This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of~     SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose~     of methotrexate.~   "
195166|NCT01008839|"~     The purpose of this study is to test a new imaging technique to help scientists study~     sarcopenia, the process by which muscle becomes weaker with age.~   "
195425|NCT01005420|"~     The purpose of this study is to evaluate the effect of blueberry powder on insulin~     sensitivity in obese, non-diabetic, and insulin resistant subjects. The investigators~     hypothesized that supplementation with blueberry powder will result in an increase in insulin~     sensitivity in obese subjects with insulin resistance.~   "
195170|NCT01008787|"~     The goal of this behavioral research study is to learn why some African American (AA) women~     choose not to exercise often and to learn if teaching African American women how to support~     the exercise habits of a partner will increase their physical activity and help them to stay~     more active over time.~      The primary goal of the proposed intervention is:~      Aim 1: To conduct formative research using semi-structured in-depth interviews and focus~     groups with sedentary AA women to investigate the role and importance of social support for~     PA;~      Aim 2: To determine the feasibility of recruiting and implementing Culturally Appropriate~     Physical Activity Motivational Interviewing (CAPMI) intervention in sedentary AA women;~      Aim 3: To pilot test and evaluate the efficacy of the CAPMI in increasing PA, social support,~     self-efficacy and reducing barriers to Physical Activity (PA) at post-intervention compared~     to an attention control group.~   "
195171|NCT01008774|"~     Primary objective:~        -  Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading)~      Secondary objective:~        -  Compliance to scalp cooling procedure~        -  Received number of cycles of chemotherapy in each subgroup~        -  Patient perception of scalp cooling procedure~        -  Side effects of scalp cooling systems~   "
195172|NCT01008761|"~     To determine if treatment of pre-school children with a history of wheeze who present to an~     Emergency Department with an acute wheezing episode with azithromycin for 5 days will resolve~     their symptoms more quickly, will require less short acting beta agonist (SABA), and allow~     these children to remain symptom free for a longer period of time.~   "
195173|NCT01008748|"~     The goal of this study is to learn how neighborhood and individual factors affect the ability~     to stop smoking among Spanish-speaking Mexican American (MA) smokers who want to quit~     smoking.~   "
195174|NCT01008735|"~     The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma~     (HL) since 1988. This archive represents a homogeneous series of consecutive patients with~     HL. The very long follow up and the availability of clinical and treatment data make it~     feasible to perform a study on the gonadal toxicity related to treatment for HL.~   "
195175|NCT01008722|"~     The study is conducted in patients with atrial fibrillation undergoing clinically prescribed~     ablation. The study hypothesis is that ablation at specific sites that are identified to~     'drive' the atrial fibrillation may improve the success of the ablation procedure.~   "
195176|NCT01008709|"~     Intracorporeal suturing and knot tying during robotic prostatectomy and laparoscopic and~     robotic renal surgery have historically been considered the most technically challenging and~     time consuming aspects of these procedures. With improved operative technique as well as the~     use of innovative surgical devices, vascular control during these surgeries is often less~     cumbersome as compared with traditional techniques. Current standard methods of hemostasis~     include the use of clips, of which the most popular design is the Hemolock, a locking,~     nonabsorbable plastic clip, or the use of the very expensive endomechanical stapler.~     Unfortunately while they are associated with time savings in the operating room, there is a~     great deal of disposable costs associated with these various devices as well as a not~     insignificant device malfunction rate reported in the literature. The aim of this~     case-controlled study is to evaluate the Aesculap U-clip device compared to our current~     technique of vascular control using the Teleflex Hemolock clip device during minimally~     invasive genitourinary surgery.~   "
195177|NCT01008696|"~     The purpose of this study is to compare the treatment effects of rabeprazole and lansoprazole~     depending on the genotyping (process of determining the genetic constitution) of CYP2C19 in~     treating reflux esophagitis (caused by gastroesophageal reflux; deterioration of the~     protective lining on the inner wall of the lower esophagus); and to evaluate the cure rate of~     reflux esophagitis on endoscopy (a thin flexible tube with a microscopic camera at the end~     which is passed down your throat into the esophagus, stomach, and duodenum) after treatment~     with rabeprazole and lansoprazole.~   "
195178|NCT01008683|"~     Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination~     according to the clinical guidelines.~      In these patients the investigators will measure the specific antibody production.~   "
195179|NCT01008670|"~     The primary goal of this study is to develop techniques to identify the course of the phrenic~     nerve in patients already undergoing cardiac resynchronization therapy (CRT) implantation or~     candidates for future CRT devices undergoing implantable cardioverter-defibrillator (ICD) or~     pacemaker implantation. Specifically, the study intends to identify the location and course~     of the left pericardiophrenic vein, and thus the left phrenic nerve, to guide the location~     for coronary vein lead placement and minimize the risk of phrenic nerve stimulation.~   "
195180|NCT01008657|"~     The primary purpose of the trial is to demonstrate that at least a 40% drop of recurrence~     rate can be achieve in hepatocellular carcinoma patients treated with no touch multipolar~     radiofrequency ablation technique compared to those treated with usual intranodular~     multipolar technique.~   "
195181|NCT01008644|"~     Primary hypothesis: osmolality changes influence the sensitivity of the respiratory center to~     carbon dioxide, hyponatraemia causing hyperventilation, and hypernatraemia depressing~     ventilation.~      Secondary hypothesis: There are gender differences in the sensitivity to osmolality changes.~      10 women and 10 men will on different occasions drink water or receive hypertonic saline~     intravenously, in order to lower or increase plasma osmolality. The women will participate~     during both faces of the menstruation cycle. On each occasion the subject´s sensitivity to~     carbon dioxide will be tested, and blood samples will be drawn for analysis of blood~     gases,electrolyte and osmolality.Subjects who interrupt participation before completion of~     all planned occasions, will be substituted, so that 10 subjects of either sex will have~     participated as planned. All results from all participants will be analyzed.~   "
195182|NCT01008631|"~     The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure~     and in healthy volunteers will be after two single shot applications.~   "
195183|NCT01008618|"~     The purpose of this study is to evaluate efficacy and safety of fentanyl in opioid-naive~     participants with osteoarthritis (disorder, which is seen mostly in older persons, in which~     the joints become painful and stuff) or low back pain who cannot obtain a sufficient~     analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).~   "
195184|NCT01008605|"~     The purpose of this study is to demonstrate the usability of the system.~   "
195185|NCT01008592|"~     Levocetirizine (Xyzal®), the active levorotatory enantiomer of cetirizine (Zyrtec®), is a~     FDA-approved drug used in the treatment of symptoms associated with seasonal and perennial~     allergic rhinitis and chronic idiopathic urticaria. The parent compound, cetirizine was shown~     to be effective against experimental dermatographism, however no study has been conducted so~     far on the effect of levocetirizine on the inhibition of dermatographism. It is known that~     cetirizine is a mast-cell stabilizer and decreases histamine levels and the number of~     tryptase positive mast cells. Cetirizine inhibits the production of interleukin 8 (IL8) and~     leukotriene B4 (LTB4) by immune cells - two potent chemoattractants - and induces the release~     from monocytes of prostaglandin E2 (PGE2), a suppressor of antigen presentation and MHC class~     II expression. However, the effects of the most active enantiomer levocetirizine on these~     inflammatory mediators have not been evaluated so far. Therefore, we aim to conduct a study~     in humans with dermatographism and chronic idiopathic urticaria to evaluate the effect of~     levocetirizine on the above-mentioned mediators. The study will involve the use of skin~     microdialysis, a minimally invasive technique to measure inflammatory mediators in the~     extracellular space in dermis.~   "
195186|NCT01008579|"~     Patient reported outcome measures (PROMs) are assessments of health status or health-related~     quality of life. The EuroQol-5D (EQ5D) is an example of a generic instrument to assess~     health-related quality of life. The investigators will use the EQ5D in the Falls Prevention~     Clinic as part of routine clinical assessment at baseline, 6 months and 12 months to track~     patient care in a cohort of 300 older adults who are at high-risk of falls.~   "
195187|NCT01008566|"~     This phase I trial is studying the side effects and best dose of cixutumumab when given~     together with sorafenib tosylate in treating patients with advanced liver cancer. Monoclonal~     antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with~     sorafenib tosylate may kill more tumor cells.~   "
195188|NCT01008553|"~     The purpose of this study is to evaluate the efficacy and safety of fentanyl in opioid-naive~     participants with post-herpetic neuralgia, complex regional pain syndrome or post-operative~     pain syndrome who cannot obtain a sufficient analgesic effect by the treatment of non-opioid~     analgesics (drug used to control pain).~   "
195189|NCT01008540|"~     The investigators aim is to determine the incidence of cytomegalovirus resistance to~     antivirals in a cohort study. The patients are included at their first CMV active infection~     and are followed during two years thereafter. When criteria for suspected resistance are~     meet, blood and urine samples are collected for virus isolation and further resistance~     phenotype, and for resistance genotype determination. Results are compared with baseline~     samples. Clinical information such as treatment, immunosuppressive regimen and clinical~     evolution will be collected. Through this study, the investigators aim to organize a national~     network for the detection and identification of CMV resistant strains that will be useful~     when new therapeutics will be available.~   "
195190|NCT01008527|"~     The purpose of this study is to determine what side effects CP 870,893 may cause when given~     with an immune stimulant called Oncovir poly IC:LC along with a melanoma vaccine. The CP~     870,893, the Oncovir poly IC:LC and the melanoma vaccine are investigational drugs that have~     not been combined in patients before, and that have not been approved for sale by the Food~     and Drug Administration. The Oncovir poly IC:LC is intended to stimulate the body's immune~     system.~   "
195191|NCT01008514|"~     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near~     a tumor to kill tumor cells. It may also cause less damage to normal tissue.~      PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in~     treating women with early-stage breast cancer.~   "
195192|NCT01008501|"~     The researchers' laboratory is studying a rare class of highly recurrent hydatidiform moles.~     These are usually complete hydatidiform moles (CHM), but sometimes they are partial~     hydatidiform moles PHM). With sporadic moles, the difference between CHMs and PHMs is that~     with CHMS, there is not typically an embryo or fetus at the time of diagnosis but with a PHM~     there may be a fetus. Also, CHMs have 46 chromosomes in each cell. While this is the number~     of chromosomes that should be found, the problem is that all the chromosomes come from the~     father. Normally, half the chromosomes should come from the mother and half should come from~     the father. Unlike CHMs, PHMs have 69 chromosomes. This means that PHMs have three copies of~     each chromosome when they should only have two. The extra copy comes from the father.~      The researchers' study focuses on moles that are genetically different from these sporadic~     moles in that they have 23 chromosomes from the mother and 23 chromosomes from the father -~     just like a normally developing pregnancy. These are called biparental moles because the~     mutation that causes the mole comes from both parents. This mutation occurs in a gene called~     NLRP7. The researchers' team is working to understand how mutations in NLRP7 leads to CHMs~     and how these mutations may lead to other types of pregnancy loss. The researchers are also~     trying to discover other genetic and epigenetic factors that may lead to moles.~   "
195193|NCT01008488|"~     The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of~     uncomplicated colonic diverticulitis.~      The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover~     the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to~     complications.~      The patients will be randomized to conservative treatment with and without antibiotic~     therapy.~   "
195194|NCT01008475|"~     The purpose of this study is to assess the safety and clinical activity of the experimental~     drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination~     with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.~   "
195242|NCT01007838|"~     The purpose of this study is to investigate the effects of a 12 week progressive resistance~     training during haemodialysis on muscle quantity and physical functioning in chronic kidney~     disease patients receiving maintenance haemodialysis.~      It is hypothesised, based on previous literature involving similar resistance training~     protocols in other catabolic conditions, that the resistance training will result in a~     significant increase in muscle quantity as well a physical function.~   "
195243|NCT01007812|"~     The purpose of this trial is to compare the performance of two different contact lenses for~     contact lens wearers with astigmatism.~   "
195195|NCT01008462|"~     This phase II trial studies autologous peripheral blood stem cell transplant followed by~     donor bone marrow transplant in treating patients with high-risk Hodgkin lymphoma,~     non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia. Autologous stem cell~     transplantation uses the patient's stem cells and does not cause graft versus host disease~     (GVHD) and has a very low risk of death, while minimizing the number of cancer cells.~     Peripheral blood stem cell (PBSC) transplant uses stem cells from the patient or a donor and~     may be able to replace immune cells that were destroyed by chemotherapy. These donated stem~     cells may help destroy cancer cells. Bone marrow transplant known as a nonmyeloablative~     transplant uses stem cells from a haploidentical family donor. Autologous peripheral blood~     stem cell transplant followed by donor bone marrow transplant may work better in treating~     patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic~     lymphocytic leukemia.~   "
195196|NCT01008449|"~     The objective of this randomized controlled trial is to compare wound morbidity (including~     disruption and infection) in surgical staples versus absorbable subcuticular suture for wound~     closure in cesarean deliveries.~   "
195197|NCT01008436|"~     The study enrolles all consecutive patients undergoing cardiac surgery at the European~     Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis~     or added topical application of Omni-stat Celox.~      The two populations are followed up prospectively as regarding blood loss and need for blood~     transfusions, as well as adverse events at 30 days after surgery.~   "
195198|NCT01008423|"~     The purpose of this study is to establish the efficacy profile of rectally administered~     budesonide foam administered as 2mg/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks,~     as compared to an equivalent volume of rectally administered placebo foam over the same~     dosing schedule, in subjects who present with a diagnosis of active, mild to moderate,~     ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible~     subjects will be allowed to maintain previously established oral 5-ASA treatment at doses up~     to 4.8g/day.~   "
195199|NCT01008410|"~     The purpose of this study is to establish the efficacy profile of rectally administered~     budesonide foam administered as 2mg/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks,~     as compared to an equivalent volume of rectally administered placebo foam over the same~     dosing schedule, in subjects who present with a diagnosis of active, mild to moderate,~     ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible~     subjects will be allowed to maintain previously established oral 5-ASA treatment at doses up~     to 4.8g/day.~   "
195200|NCT01008397|"~     Objectives:~      A) To gather pharmacodynamic measurements and assess blood levels of the active ingredients~     in AHIST over the dosage interval period of 12 hours.~      Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour~     dosage interval will substantiate S5 Symptom Diary scores (IE: evidentiary therapeutic window~     data);~      B) To report subjective scores by subjects rating the efficacy of a single dose AHIST in~     relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over a~     12-hour dosage interval.~      Hypothesis: Greater than 66% of subjects will document clinically significant relief over a~     12-hour period from one dose of AHIST;~      C) Report any side effects or adverse drug reactions and rate the severity of any incidence.~      Hypothesis: Not more than one patient will have an adverse event significant enough to~     warrant withdrawal; side effects will be mild with the most frequently reported side effect~     occurring in less than 10% of patients—drowsiness.~   "
195201|NCT01008384|"~     Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to~     others, and available as a dietary supplement. It is also produced in the body when~     ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D is~     essential for promoting calcium absorption and maintaining adequate serum calcium and~     phosphate concentrations to enable normal mineralization of bone and bone growth. Without~     sufficient vitamin D, bones can become thin, brittle, or misshapen. Vitamin D sufficiency~     prevents rickets in children and osteomalacia in adults. Together with calcium, vitamin D~     also helps protect older adults from osteoporosis. Many people have low levels of Vitamin D.~     Replacing Vitamin D is thought to help lower the risk of heart disease. Vitamin D may be~     helpful, but it could also be harmful. The investigators are studying the effect of Vitamin D~     on the level of a harmful kind of cholesterol. Participants will have their cholesterol~     levels measured and then receive either Vitamin D or a placebo. After 2 months of treatment,~     the investigators will measure their cholesterol levels again.~   "
195202|NCT01008371|"~     The purpose of this study is to determine abnormal neuro-hormonal mechanisms that may impair~     the ability to feel full and which therefore, may lead to obesity.~   "
195203|NCT01008345|"~     Randomized study. Patients with coronary artery disease equivalent will be randomized to~     receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day.~     Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment.~     Hypothesis is that ezetimibe will lower oxidized LDL~   "
195204|NCT01008332|"~     The prevalence of allergic sensitisation to House Dust Mite (HDM) varies from region to~     region and depends on the regional prevalence of HDM. In the third National Health and~     Nutrition Examination Surveys, 54.3% of the US population had positive test responses to one~     or more allergens, with the prevalence for HDM being 27.5%. Like many other allergens,~     exposure to HDMA in sensitised patients is associated with poorer lung function, greater~     medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms.~      ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine,~     currently being developed for the treatment of Houst Dust Mite allergy.~      The purpose of the present study is to evaluate the safety and tolerability of multiple~     ascending doses of ToleroMune HDM in subjects in subjects with a documented history of~     allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM~     will also be explored in these subjects using the Late Phase Skin Response, Early Phase Skin~     Response and Conjunctival Provocation Test.~   "
195205|NCT01008319|"~     The purpose of this study is to compare the length of time to achieve ovulation and pregnancy~     with a traditional protocol administration of clomiphene citrate versus a stair step~     administration.~      Our hypothesis is by using a stair-step approach in which a period is not induced between~     administrations of escalating doses of clomiphene citrate, the time to ovulation and~     pregnancy may be reduced.~   "
195244|NCT01007799|"~     The purpose of this study is to examine if vitamin D improves the symptoms of chronic~     sinusitis.~   "
195206|NCT01008306|"~     Renal transplantation of children started in Norway in 1970.Since the beginning, >80% of~     renal transplants are provided from Living Donors(mainly parents), short pre-transplant~     dialysis time( median 4 months) and 50% of transplantations are performed before dialysis is~     needed.This gives good premises for graft survival and avoidance of detrimental effects of~     dialysis. However, renal transplanted children are subjected to an increased cardiovascular~     morbidity and mortality in adulthood due to consequences of chronic renal failure and~     immunosuppressive treatment.Cardiovascular death comprises 30-40% of death causes. In this~     cross-sectional study we evaluate cardiovascular risk factors in childhood- and also in young~     adults renal transplanted in childhood.~      Focus is cardiorespiratory fitness using treadmill testing,24h BP measurements,~     anthropometrics including waist circumference,echocardiography,intima media thickness of~     carotids, glucose intolerance test.Participants are also requested to fill out physical~     activity recalls and Quality of life questionnaires.~   "
195207|NCT01008293|"~     This study is a randomized, open, parallel group, active comparator, single center trial.~     Objectives of the study are hereby given below:~        -  To study the health related quality of life (HRQOL) in patients with chronic liver~          disease.~        -  To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with~          chronic liver disease and assessment of HRQOL in patients with MHE.~        -  To compare the effect of probiotics and lactulose in the treatment of MHE~        -  To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.~   "
195208|NCT01008280|"~     Hepatitis C (HCV) is the most common blood born virus in the United States, affecting 1.8% of~     the general population and more than 5% of Veterans using VA facilities. As Veterans with HCV~     have high rates of co-morbid alcohol use disorders that accelerate greatly the liver damage~     caused by HCV, a safe and effective treatment for alcohol use disorders is needed. Baclofen~     is a novel treatment for alcohol use disorders that has minimal effect on the liver and may~     represent a safe and efficacious treatment option for Veterans with HCV and co-morbid alcohol~     use disorders.~   "
195209|NCT01008267|"~     SWL is widely used in the treatment of patients with renal and ureteral calculi. Several~     factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney~     stones: stone size, stone location within the collecting system, stone type, and the SWL~     machine used. Moreover, in some cases it is very difficult to focus on the stone because of~     its movement as a results of breathing. In order to prevent stone movement we want to use a~     bronchial blocker, processing a selective ventilation of the opposite side of stone location.~   "
195210|NCT01008254|"~     Musical reminder will raise compliance with mobility in the long-term care setting and reduce~     facility-acquired pressure ulcers.~   "
195211|NCT01008241|"~     The goal of this cross-sectional study is to gain an understanding of the knowledge and~     attitudes regarding end of life issues and hospice care among a sample of residents of South~     Florida recruited through time and space sampling. This study is being conducted by OMS3 COM~     research fellow Heather Ruff as part of the research fellowship requirements.~      Participants will complete a paper and pencil questionnaire that measures 4 domains of~     interest (advanced care planning; end of life care; hospice care and death and dying) as well~     as demographic factors (age, marital status, education etc.). It is estimated that the survey~     will take 15 minutes to complete. Data will be collected anonymously, with no personal~     identifying information. The instructions on the questionnaire state that by completing the~     questionnaire, the participant is providing consent to participate in the study. We will use~     time and space sampling methods to recruit up to 250 participants at community venues (i.e.,~     beaches, street corners, parks, pedestrian malls, and other public venues were people~     congregate) in South Florida. At each venue, we will define a specific area; persons who~     enter the defined area will be approached, screened for eligibility (18 years of age or older~     and a resident of South Florida), and if eligible, invited to participate by trained research~     staff. Sampling intervals will be determined by traffic flow at each venue. If a person~     agrees to participate they will be given a paper and pencil copy of the survey to complete on~     the spot. Participants will be given $1.00 as a token of appreciation. Data entry and data~     analyses will be done using SPSS.~   "
195212|NCT01008228|"~     Management of primary spontaneous pneumothorax (PSP) remains unclear. Primary therapeutic~     goals for PSP include removal of air from the pleural space an prevention of recurrences. The~     absence of generally accepted and methodologically sound recommendations may account for the~     extensive variation in practice for air evacuation techniques. Air evacuation may be achieved~     by simple aspiration (exsufflation) or conventional chest tube drainage. Chest tube~     thoracotomy remains the most popular technique.Aspiration is a more simple technique, that~     allows possibility of ambulatory management. The purpose of the present study is to compare~     simple aspiration performed with a specific thoracentesis device, versus conventional chest~     tube drainage. Comparison will be performed on immediate efficacity of resolution of the~     pneumothorax.The hypothesis is that simple aspiration performed with a specific device is not~     inferior to chest tube drainage for management of a first episode of large size primary~     spontaneous pneumothorax. A second goal is to measure the efficacy at one week, and the~     recidive at one year. The trial is randomized, controlled and will include 200 patients for~     each group. The patients will be enrolled in 29 hospitals in France. Emergency department,~     thoracic surgery and pulmonary departments of each hospital were primarily contacted for~     agreement to participate to the study.~   "
195213|NCT01008215|"~     Can a simple and cost-free tool help family physicians to improve dosing of the blood thinner~     warfarin?~      Warfarin is a blood thinner with a variable effect and requires regular blood monitoring and~     dose adjustments. Some family practices do not have the facilities or funding to use~     commercial tools than can assist with stabilizing the effect of warfarin. The investigators~     will test whether a simple and cost-free dosing tool can help these practices to improve~     warfarin management.~      If this simple tool improves warfarin management, it will be freely available for practices~     in Canada and around the world. This will help physicians who have no access to more costly~     and/or complicated tools improve their warfarin dosing practice in a systematic fashion, and~     thereby maximize the health benefit of warfarin.~   "
195256|NCT01007643|"~     To determine the utility of the Wii Fit TM interactive video game program in patellofemoral~     symptom resolution, development of increased muscle strength and flexibility as a result of~     increased compliance with home exercises in adolescent females with patellofemoral syndrome.~   "
195214|NCT01008176|"~     Cutting back on sleep duration has developed into a common, highly prevalent habit in the~     adult population, and may lead to a major health problem. Large epidemiological studies have~     demonstrated that short sleep duration is associated with increased risk of cardiovascular~     disease (CVD). The investigators' preliminary data on the effects of experimental sleep~     reduction have shown elevation of blood pressure (BP) and inflammatory markers, such as~     interleukin-6 (IL-6) and C reactive protein (CRP), suggesting that both may play an important~     role in linking sleep loss and CVD risk. With this background, the investigators hypothesize~     that restoring sleep homeostasis, i. e. getting adequate amounts of sleep, is an effective~     behavioral intervention in the treatment of elevated BP.~      The investigators will test this hypothesis in subjects with BP above normal and with short~     habitual sleep duration, as verified by sleep logs and actigraphic recordings. Subjects will~     either undergo 6 weeks of mild sleep extension, in which 60 min of bedtime will be added to~     the habitual sleep duration, or subjects will maintain their habitual sleep duration for the~     following 6 weeks.~      Regarding their first specific aim, the investigators expect that sleep extension across 6~     weeks will lower BP, inflammatory (IL-6, CRP, cell adhesion molecules) and autonomic markers~     (catecholamines). In particular, the investigators expect that in subjects with mild BP~     elevation, i. e. with pre-hypertension, sleep extension leads to normalization of BP.~      This study presents a very first approach in using sleep behavior components for the~     treatment of elevated BP. Therefore, the investigators' second specific aim will characterize~     the strength of associations between changes in sleep duration, BP, and inflammation, and~     they will explore factors that are predictive for these changes. In particular, adiposity, as~     measured by percent body fat, has frequently been shown to be related to short sleep duration~     and inflammatory processes, but the role of adiposity in modulating the physiological~     consequences of changes in sleep duration has never been addressed.~      If the investigators' hypothesis is correct, sleep extension may be considered as an~     additional component in current lifestyle intervention programs in combating and preventing~     hypertension.~   "
195215|NCT01008150|"~     FB-7 is a Phase II, multi-center randomized study of neratinib in combination with weekly~     paclitaxel with or without trastuzumab followed by doxorubicin and cyclophosphamide (AC) as~     neoadjuvant therapy for women with HER2-positive locally advanced breast cancer. Patients in~     the control arm will receive neoadjuvant trastuzumab in combination with weekly paclitaxel~     followed by AC. The primary aim of the study is to determine the pathologic complete response~     (pCR) rate in breast and axillary nodes following the neoadjuvant therapy regimens. The~     secondary aims include determination of the pCR rate in breast only, clinical complete~     response (cCR) rate, two-year recurrence-free interval, two-year overall survival, toxicity~     of the neoadjuvant regimens, and exploration of molecular and genetic correlates of response.~   "
195216|NCT01008137|"~     A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years)~     to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's~     H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).~   "
195217|NCT01008124|"~     This study is being done because the investigators would like to know how effective the~     Liberatory maneuver is in treating benign paroxysmal positional vertigo (BPPV).~   "
195218|NCT01008111|"~     The purpose of this research study is to test the safety of an oxygen producing gel (produced~     by combining baking soda and hydrogen peroxide) and see what effects (good and bad) it has on~     skin incisions in children.~      Baking soda and hydrogen peroxide have been approved by the US Food and Drug Administration~     (FDA), but have not been approved for use in this manner.~      It is hypothesized that a combination of sodium bicarbonate and hydrogen peroxide may enhance~     wound healing of incisional wounds for bilateral hernia repair.~   "
195219|NCT01008098|"~     The objectives of the current study are~        1. to evaluate the efficacy of escitalopram in treatment for post-traumatic stress~          disorder,~        2. to find the structural changes of brain using magnetic resonance imaging and its~          association with the symptoms reduction, and~        3. to look at the differences of brain imaging findings and symptoms changes according to~          genetic differences of brain-derived neurotrophic factor (a biological molecule~          facilitating neuronal growth in human).~   "
195220|NCT01008085|"~     Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the~     struts to the vessel wall than a balloon-expandable stent within a few days after the~     procedure in acute myocardial infarction patients.~   "
195221|NCT01008072|"~     The methods of detoxification under general anesthesia have been criticized because of~     limited data on safety and long-term follow-up. Premedication with buprenorphine has been~     advocated to improve safety. In current study we want to evaluate the importance of~     buprenorphine preparation in rapid opioid detoxification process, under general anesthesia.~   "
195222|NCT01008059|"~     To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A~     activity.~   "
195223|NCT01008046|"~     The purpose of this study is to compare and determine the efficacy of combined N-acetyl~     cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with~     Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.~   "
195224|NCT01008033|"~     The purpose of this study is to evaluate the safety and efficacy of topical application of~     IDP-108 versus vehicle in treating patients with onychomycosis.~   "
195225|NCT01008020|"~     The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the~     prevention of influenza infection.~   "
195226|NCT01008007|"~     The purpose of the study is to assess the safety and effect of Viusid (bags of 4 grams)~     administration in the treatment of acute fever of viral etiology as diagnosed by clinical,~     hematologic and serologic parameters. The duration of this open and randomized phase 2~     clinical trial will be 6 days. The estimated number of persons with acute fever of viral~     etiology to be recruited and randomized for the study is 200. The primary outcome measure:~     platelet, leukocyte and granulocyte count will be assessed at the beginning and the end of~     the study.~   "
195227|NCT01007994|"~     The proposed study will investigate the effect of chronotherapeutic alteration of~     anti-hypertensive medication on nocturnal hypertension and end-organ injury in pediatric~     renal transplant recipients who are non-dippers. Additionally, the investigators aim to~     examine the association between response to intervention, serum adiponectin levels and~     adiponectin gene polymorphisms. The investigators hypothesize that (1) evening administration~     of anti-hypertensive medication will convert subjects from non-dipper to dipper status,~     improve mean nocturnal blood pressure (BP), and improve nocturnal BP load, (2) evening~     administration of anti-hypertensive medication will reduce albuminuria, left ventricular mass~     index (LVMI), rate of decline of glomerular filtration rate (eGFR) and will decrease pulse~     wave velocity (PWV), and (3) lower adiponectin levels and presence of adiponectin gene~     polymorphisms will be associated with less of a response to the intervention.~   "
195228|NCT01007981|"~     The investigators hypothesize that the relation between mechanical and hemodynamic left~     ventricular dyssynchrony might better predict response to Cardiac Resynchronization~     Device(CRT) than currently existing echo indices.~   "
195229|NCT01007968|"~     Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel~     cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC~     inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients~     with solid tumors and hematological malignancies.~      To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with~     solid tumors and hematological malignancies participating in several phase I/II clinical~     studies. Panobinostat PK does not appear to be different in patients with solid tumors and~     hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is~     yet to be elucidated.~      Kidney and liver are involved in the elimination and metabolism of panobinostat. The current~     study is designed to evaluate the impact of hepatic function status on panobinostat PK.~   "
195230|NCT01007955|"~     The purpose of this research is to further study the effect weight loss after gastric bypass~     surgery has on the heart and blood pressure and on how the body uses or metabolizes the~     sugars, fats and proteins we eat. Additionally, the researchers want to study fat tissue for~     gene patterns which may be responsible for where we carry fat on our bodies, as well as look~     carefully at a possible link between adipose tissue and insulin resistance. The researchers~     also want to evaluate the liver for the presence of fatty liver, which is common in people~     with obesity and is associated with insulin resistance, as well as study the liver for gene~     patterns which may be associated with non-alcoholic liver disease.~      Evaluating cardiovascular function and endocrine function before and after gastric bypass~     surgery, as well as studying adipose and liver tissue may help us understand the link between~     obesity, insulin resistance, fatty liver disease, high blood pressure and health problems~     such as diabetes and heart disease. Consequently, this may help in the future by identifying~     those who will benefit most from gastric bypass surgery.~   "
195231|NCT01007929|"~     The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics~     of a single oral dose of [14C] AZD1236 in healthy male subjects.~   "
195232|NCT01007916|"~     The purpose of this study is to compare the performance of commercially marketed contact~     lenses to habitual contact lenses in a selected segment of the contact lens wearing~     population.~   "
195233|NCT01007903|"~     This is a pilot randomized controlled trial of feasibility and preliminary effects of a 12~     week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary~     disease~   "
195234|NCT01007890|"~     The objective of this study is to develop a biomarker to predict pathological complete~     response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker~     would assist physicians in selecting the most effective chemotherapy for the individual~     patient.~   "
195235|NCT01008358|"~     CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T~     lymphocytes and by enhancing their activation may produce a stimulation of the immune~     response against tumoral or viral antigens. In this clinical trial, the ability of~     tremelimumab to produce tumor responses among hepatitis C virus-infected patients with~     hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the~     effect on the replication of the virus will be analysed.~   "
195236|NCT01008189|"~     Six-years following participation in the Family Bereavement Program (FBP) participants in the~     program as compared to a self-study control group will have lower levels of mental health~     problems, lower one-year prevalence of mental disorder that meets diagnostic criteria, lower~     use of substances, higher levels of competence at achieving developmentally appropriate tasks~     in academic achievement and social competence, and better self-esteem. The effects of the FBP~     will be moderated by baseline levels of mental health problems and gender. Bereaved~     caregivers who participated in the program will also show lower levels of mental health~     problems as compared with controls.~      Program effects will be mediated by theoretical mediators targeted by the program.~   "
195237|NCT01008163|"~     The purpose of this trial is to determine the dosage selected and to evaluate the efficacy~     and safety of YY-351.~   "
195238|NCT01007942|"~     This phase III, double-blind, placebo-controlled multinational study will assess the~     combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine~     and trastuzumab with respect to progressive-free survival and over survival in HER2/neu~     positive women with locally advanced or metastatic breast cancer who are resistant to~     trastuzumab and have been pre-treated with a taxane.~   "
195239|NCT01007877|"~     Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed~     that a 15-minute break and consuming an energy drink such as Red Bull® Energy Drink~     counteracts driver sleepiness.~      Objective: The objective of this study is to compare driving simulator performance after (1)~     a 15-minute break with placebo, (2) a 15-minute break with Red Bull® Energy Drink, and (3)~     continued driving.~      Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy~     human volunteers, 21-35 years old.~      Intervention: Each subject performs 3 test days:~        1. 4 hours continued driving~        2. 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving~        3. 2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study~          parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of~          the car.~   "
195240|NCT01007864|"~     The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine~     agonist piribedil on vigilance and cognitive performances in patients with Parkinson's~     disease in comparison with other oral non-ergot dopamine agonists.~      It should be tested whether piribedil is superior to continued pramipexole or ropinirole~     treatment regarding improvement of reduced vigilance and cognitive performance in patients~     with Parkinson's disease.~   "
195241|NCT01007851|"~     GnRH agonist administration in the luteal phase was reported to beneficially affect clinical~     outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single~     dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles~     stimulated with the fixed GnRH antagonist protocol. Women undergoing embryo transfer~     following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were~     included. In addition to routine luteal phase support with progesterone women were randomized~     to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing~     pregnancy rate was the primary outcome measure.~   "
195753|NCT01001104|"~     The main purpose of this study is to assess dose-response characteristics in Japanese~     patients with Type 2 Diabetes taking LY2189265 monotherapy.~   "
195245|NCT01007786|"~     Shunt failure remains a significant problem in pediatric patients with hydrocephalus. If~     reliable techniques for the accurate placement of ventricular catheters can be developed,~     shunt survival may improve. The purpose of this study is to assess the efficacy and safety of~     the ultrasound guided shunt insertion technique in the hands of experienced surgeons. The~     primary outcome measure is ventricular catheter location determined from post-operative brain~     images. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a~     network established to conduct multi-institutional clinical trials on pediatric~     hydrocephalus. Pediatric neurosurgeons at HCRN centers enrolled in this study will perform~     either ultrasound guided shunt surgery or a conventional shunt surgery. Patients who undergo~     conventional shunt surgery will serve as a contemporary control group.~   "
195246|NCT01007773|"~     The aim of this study is to assess the safety and feasibility of dexmedetomidine as an~     adjunct to conventional sedative therapy compared to conventional sedative therapy alone in~     patients with severe traumatic brain injury.~   "
195247|NCT01007760|"~     The purpose of this study is to determine the vascular effects of brief second-hand smoke~     exposure on normal healthy individuals.~   "
195248|NCT01007747|"~     The purpose of this study is to determine if Geranium oil will relieve a variety of~     neuropathic pain and some pain relief will last more than 48 hours.~   "
195249|NCT01007734|"~     The purpose of this study is to evaluate with sufficient precision and according to gender~     the determining independent factors of quality of life related to respiratory status of~     patient with moderate to severe COPD.~   "
195250|NCT01007721|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     BI 671800 ED using three dose levels of BI 671800 ED (50 mg, 200 mg and 400 mg), administered~     twice daily compared to FP (fluticasone propionate) nasal 100 mcg per nostril qd in the~     morning or Montelukast 10 mg qd am given for 2 weeks in patients with SAR (seasonal allergic~     rhinitis) out of season using an environmental exposure chamber in patients known to be~     sensitive to the aero-allergen Dactylis glomerata.~   "
195251|NCT01007708|"~     The purpose of this study is to evaluate the safety and efficacy of topical application of~     IDP-108 versus vehicle in treating patients with onychomycosis.~   "
195252|NCT01007695|"~     The investigators' hypothesis is that valproic acid given before surgery for newly diagnosed~     breast cancer will increase breast tumor histone acetylation at tolerable doses and that the~     increase in breast tumor histone acetylation will correlate with valproic acid blood levels~     and changes in peripheral blood white blood cell histone acetylation. Published in vitro~     studies have shown sensitivity of breast cancer cells to histone deacetylase inhibitors~     (Fortunati et al., 2008; Fuino et al., 2003; Hodges-Gallagher et al., 2007; Olsen et al.,~     2004). The investigators' gene array data predict sensitivity to valproic acid in over half~     of breast cancers [Bild, unpublished]. The investigators hypothesize that in women with newly~     diagnosed breast cancers valproic acid will have an unacceptable toxicity rate less than 15%~     at doses that increase tumor histone acetylation and that valproic acid will decrease the~     Ki-67 in at least half of breast tumors by over 20%. The investigators also hypothesize that~     their genomically-derived signature for sensitivity to valproic acid (GDSS-VPA) can be used~     to predict which tumors will have a decrease proliferation as measured by Ki-67 by at least~     20%. The investigators hypothesize that valproic acid levels and histone acetylation levels~     in peripheral leukocytes will correlate with a decrease in the Ki-67 proliferation index by~     20%. The investigators hypothesize that DCE-MRI imaging studies will provide an accurate and~     quantitative means of assessing tumor response to valproic acid. Finally, the investigators~     hypothesize that response to valproic acid will not be affected by intrinsic breast cancer~     subtype.~   "
195253|NCT01007682|"~     This study aims at identifying risk factors for the development of intrusive reexperiencing~     symptoms. In particular, the investigators examine the influence of working memory capacity~     and thought suppression on the occurrence of unpleasant memories of a negative experience.~      Hypothesis: People with high working memory capacities (HWMC) are able to successfully~     suppress memories of an unpleasant experience (presentation of a distressing movie). In~     contrast, in people with low working memory capacities (LWMC), attempts to suppress memories~     of an unpleasant experience inadvertently lead to an increase of these memories.~      Study phase one: Assessment of working memory capacity in 200 healthy participants by means~     of a computerized task. Selection of 50 participants with HWMC and of 50 participants with~     LWMC who participate in study phase two.~      Study phase two: Presentation of a distressing movie and subsequent assessment of memories of~     the movie during several days in the daily life of participants. Comparison of 4 groups~     regarding the frequency of instructions in daily life:(group 1: HWMC participants who are~     instructed to suppress thoughts of the movie, group 2: LWMC participants who are instructed~     to suppress thoughts of the movie, group 3: HWMC participants who are instructed to allow the~     occurence of thoughts of the movie, group 4: LWMC participants who are instructed to allow~     the occurence of thoughts of the movie)~   "
195254|NCT01007669|"~     The purpose of this study is to evaluate the effect of specified worksite physical-activity~     interventions on musculoskeletal disorders in an industry with physical heavy workload.~   "
195255|NCT01007656|"~     -  Study design is multiple-dose, open-label study~        -  The purpose of this study is to evaluate the safety after twice daily GD Antrodia~          camphorata administration for 90 days in 30 healthy adult subjects.~             -  Primary objective: The mean change from baseline in laboratory assessment after~               twice daily GD Antrodia camphorata administration at 90th day in 30 healthy adult~               subjects.~             -  Secondary objective: The mean change from baseline in laboratory assessment after~               twice daily GD Antrodia camphorata administration at 10th, 20th, 30th, 45th and~               60th day in 30 healthy adult subjects.~        -  Safety Measurement:~             -  including SGOT(AST), SGPT(ALT), albumin, glucose, creatinine, uric acid,~               cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, D-Bil, BUN, TP, GLO~               will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.~             -  vital signs (heart rate, blood pressure, and body temperature) will be documented~               at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.~             -  Subjects will be monitored throughout the confinement portion of the study.~   "
195426|NCT01005407|"~     The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency~     of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years~     of age~   "
195257|NCT01007630|"~     A decrease or loss of the sense of smell is very common in patients with Parkinson's Disease~     even in the earliest stages of the disease. There have been no treatments that have been~     proven to improve sense of smell in patients with Parkinson's Disease.~      Rasagiline (brand name: Azilect) was approved by the U.S. Food and Drug Administration (FDA)~     on May 16th 2006 to be used by Parkinson's patients to treat the motor symptoms associated~     with the disease. The purpose of this study is to see if there is change in sense of smell~     after starting Rasagiline.~   "
195258|NCT01007617|"~     Oral mucositis represents a major complication of cytotoxic chemotherapy among cancer in~     children. Low-power laser therapy (LPLT) has been used to reduce the incidence of oral~     mucositis in patients who are receiving high-dose chemotherapy. The aim of this study is to~     compare two preventives energies delivered of LPLT to oral mucosa in decreasing the severity~     of mucositis in children.~   "
195259|NCT01007604|"~     The purpose of this study is to evaluate the efficacy of a non-invasive peristaltic pulse~     pneumatic device (PCD) in the treatment of intermittent claudication in patients having~     documented peripheral arterial disease (PAD). The pneumatic device to be studied is FDA~     approved for the treatment of venous disease. While anecdotal evidence exists supporting a~     decrease in claudication symptoms, there are no previously published data on studies~     employing this compression device in the treatment of arterial disease. The investigators'~     primary hypothesis is that patients randomized to the intervention arm of the trial will~     experience an increase in mean walking ability as compared to the group receiving medical~     standard of care.~   "
195260|NCT01007591|"~     An international, multi-centre, prospective, randomised, double-blind, active-controlled,~     2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17~     years) with psoriasis vulgaris on the face and on the intertriginous areas~   "
195261|NCT01007578|"~     The purpose of this study is to determine plasma levels of paclitaxel and catheter~     tolerability subsequent to treating patients with peripheral arterial occlusive disease~     (PAOD) with paclitaxel-coated balloon catheters.~   "
195262|NCT01007565|"~     The investigators undertook to evaluate early postoperative pain levels after the volar~     plating of distal radius fractures performed under regional anesthesia, and to determine~     whether periarticular multimodal drug injections into the joint, ligament, periosteum,~     subcutaneous tissue, and skin, and into interosseous and superficial radial nerves (as an~     additional sensory nerve block) provide additional pain management benefits.~   "
195263|NCT01007552|"~     To assess the proposed therapy for patients with advanced gallbladder or biliary cancers.~   "
195264|NCT01007539|"~     The purpose of the study is to determine if cytidine 5'diphosphocholine (CDP-choline, a~     naturally occurring chemical in your body) has efficacy in reducing the methamphetamine~     craving of the subjects with methamphetamine dependence craving and helping them maintain the~     abstinence. In addition, investigators will measure the brain N-acetyl aspartate (a biologic~     marker for neuronal viability) level of participants to determine if brain deficits induced~     by methamphetamine may recover by taking CDP-choline.~   "
195265|NCT01007526|"~     This study is to evaluate the efficacy of risk-adapted treatment strategy for stage I/II~     extranodal NK/T cell lymphoma. The risk stratification is based on the Korean NK prognostic~     index. Thus, the group I/II will receive concomitant chemoradiation followed by VIDL~     chemotherapy. The group III/IV will receive high dose-chemotherapy followed by autologous~     stem cell transplantation after the completion of VIDL chemotherapy.~   "
195266|NCT01007513|"~     Preterm birth rate is 7.2% in Quebec, it's risen worldwide in the past decade and it's the~     leading cause of perinatal mortality and morbidity. Preterm birth is a major public health~     problem. Preterm labor leading to preterm birth is difficult to diagnose and prediction of~     preterm birth is a medical challenge. In the past years, research found that transvaginal~     ultrasound to assess the cervix of the uterus and vaginal detection of inflammatory protein,~     specific bacteria and fetal fibronectin can help to detect women at increase risk of preterm~     delivery. The investigators believe that a combination of these tests can lead to a better~     prediction of preterm delivery. The investigators want to conduct a study among women judged~     at increase risk of preterm delivery by their physician (having contractions, modified~     cervix, past-history of preterm delivery or multiple pregnancy) and assess their cervix by~     ultrasound and sample their vaginal secretion. The investigators want to analyze the vaginal~     sampling and look for inflammatory proteins. The objective of this study is to prove the~     feasibility of this assessment method and elaborate a better predictive test that the~     investigators can easily use in obstetrics clinics and hospitals.~   "
195267|NCT01007500|"~     The purpose of this study is to study the effect of dexamethasone combined with ondansetron~     on postoperative nausea and vomiting in patients with patient-controlled analgesia after~     video-assisted thoracoscopic surgery.~   "
195268|NCT01007487|"~     Hypothesis: Plastic wound retractors reduce passage of bacteria from the abdomen to the~     surgical incision site in abdominal surgery~      Currently, plastic wound retractors are used in abdominal surgery to facilitate access to the~     abdominal cavity. This study aims to establish whether they also prevent bacteria crossing~     from the abdominal cavity to the surgical incision site. Patients undergoing abdominal~     surgery in which a plastic wound retractor (Alexis®)is used are eligible for inclusion in the~     study. Swabs are taken from the inside and the outside of the plastic wound retractor prior~     to removing the retractor from the abdomen. The bacterial flora from swabs taken inside and~     outside the plastic wound protector are then compared to see if there is any difference~     between inside and outside the retractor. Bacteria are classified as 'enteric'(i.e. from the~     gastrointestinal tract) or 'skin' bacteria, depending on their usual location. The study aims~     to establish whether a plastic wound retractor (Alexis®) reduces translocation of enteric~     bacteria to the surgical incision site.~   "
195311|NCT01006928|"~     Preterm birth is a traumatic event for parents. They cope with threatening and unfamiliar~     environment of hospital, losing the parental role, and frustration. The NICU team is the main~     support source for these parents. Support and providing information are most important for~     parents, as they can have some control, involvement and self confidence during the~     hospitalization, and also feel healthier. The hypothesis of this study is that better support~     to parents lead to better subjective health feeling by them.~      The study will be held among mothers to infants in NICU who are at least 7 days old. The~     study will use a questionaire to assess the subjective health feeling and the estimation of~     the support from the team. Sample size is about 150 mothers.~   "
195269|NCT01007474|"~     The One Hospital ClinicalService Project is an integrated system composed by a network of~     International Hospital Departments, a clinical data repository and a shared environment for~     the collection, management, analysis and reporting of clinical and diagnostics data from~     patients treated by Medtronic therapies or patients wearing Medtronic implantable devices~     used within their intended use. The One Hospital ClinicalService is composed by a suite of~     systematic, data-guided activities designed to bring about immediate improvements in health~     delivery in particular settings. Data are prospectively collected. An independent committee~     of physicians prospectively identifies key clinical questions on a yearly basis for~     development of quality improvement activities, analyses and publications. A charter, approved~     by Hospital Istitutional Review Boards or other Hospital entities, assigns the ownership of~     data to the centers and governs the conduct of the project and the relationship of the~     scientific committee and Medtronic. Hospital is the data controller, while Medtronic is the~     data processor on behalf of the Hospital. Data collected for quality improvement purposes may~     be mined to perform clinical research.~   "
195270|NCT01007461|"~     Myocardial Infarctions (MI) are commonly known as heart attacks. An ST-Segment Elevation~     Myocardial Infarction (STEMI) is a more severe type of heart attack. Myocardial Infarctions~     happen when a coronary artery is partially or fully blocked suddenly by a blood clot, causing~     damage to at least some of the heart muscle being supplied by that artery. In a STEMI, a~     blood clot completely blocks the coronary artery. This can result in damage to the heart~     muscle that is supplied by the affected artery. The purpose of the IK-1001 STEMI Study is to~     evaluate the safety and effectiveness of an investigational study drug (IK-1001). IK-1001 is~     being studied to determine if it is safe and if it can reduce the amount of damage caused to~     the heart from a STEMI. Potential subjects may be eligible if they have been diagnosed with a~     STEMI and undergo a primary percutaneous coronary intervention (PCI, a procedure where a~     blocked coronary artery is unblocked during a cardiac catheterization), as well as meet other~     entry criteria. Up to 446 men and women, aged 18-80, will participate in this study at about~     50 medical sites around the world. Study participation will last for about six months.~     Subjects will receive the study drug through an intravenous catheter over three hours during~     their PCI procedure. Subjects will be monitored in the hospital for approximately three to~     four days after the PCI. There are three follow-up visits at one, three and six months after~     the PCI with the study investigator after discharge from the hospital.~   "
195271|NCT01007448|"~     This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy,~     tolerability and safety of two initial dose levels of bexarotene capsules in patients with~     refractory cutaneous T-cell lymphoma (CTCL).~   "
195272|NCT01007435|"~     This randomized, double-blind, parallel group study will assess the safety, disease~     remission, and prevention of structural joint damage in patients with early moderate to~     severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with~     methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A)~     tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4~     weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks)~     plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po~     weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can~     receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104~     weeks.~   "
195273|NCT01007422|"~     RATIONALE: Opioids lessen pain caused by cancer. Titration of opioids in the hospice setting~     is suboptimal due to numerous barriers. Order sets may help to provide timely and effective~     medical and pharmaceutical intervention.~      PURPOSE: The purpose of this study was to identify barriers to good pain control in the~     hospice setting and to develop an order set that would safely address these barriers.~   "
195274|NCT01007409|"~     To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.~   "
195275|NCT01007396|"~     The present study was to evaluate the usefulness of a whole-blood interferon-r release assays~     (IGRAs) as diagnostic tool of the latent tuberculosis infection for healthcare workers.~   "
195276|NCT01007383|"~     The purpose of this first-in-man trial is to determine the safety and tolerability of~     ascending single and multiple doses of LEO 27847 in healthy male subjects. The trial will be~     performed in two parts. In Part 1, single doses of LEO 27847 will be administered to healthy~     male subjects. In Part 2, multiple doses of LEO 27847 will be administered to healthy male~     subjects.~   "
195277|NCT01007370|"~     The investigators aim to compare two different types of supraglottic devices for tracheal~     intubation in patients undergoing elective surgery under general anesthesia.~      Our hypothesis is that the use of the I-gel supraglottic airway will result in a higher first~     attempt success rate of blind tracheal intubation.~   "
195278|NCT01007357|"~     This project will facilitate the optimization of body MR imaging at 3 Tesla.~   "
195279|NCT01007344|"~     The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4~     weeks could potentially reduce the serum lipid levels in children and adolescents with~     familial or severe hypercholesterolemia compared to those on placebo.~   "
195280|NCT01007331|"~     The objective of the study is to examine whether 8 weeks intervention with probiotics~     influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence~     of the immunologic status and the intestinal microflora, inflammation and permeability will~     be investigated.~   "
195281|NCT01007318|"~     The aim of this study is to investigate the safety and efficacy of single port laparoscopic~     appendectomy compared with conventional laparoscopic appendectomy in adults with acute~     appendicitis.~   "
195307|NCT01006980|"~     This randomized, open-label study evaluated the efficacy, safety and tolerability of~     vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with~     metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally~     twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was~     continued until disease progression or unacceptable toxicity occurred. The data and safety~     monitoring board recommended that patients in the dacarbazine group be allowed to cross over~     to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both~     overall survival and progression-free survival endpoints had met the prespecified criteria~     for statistical significance in favor of vemurafenib.~   "
195282|NCT01007305|"~     This is a pilot study to assess the feasibility of conducting a randomized, blinded,~     controlled trial of bilateral salpingo-oophorectomy (BSO, removal of the ovaries and~     fallopian tubes) versus ovarian conservation among premenopausal women age 40 years and~     greater who plan to undergo hysterectomy for a benign gynecologic condition. Subjects will be~     randomized to BSO or ovarian conservation concomitant with hysterectomy and remain blinded to~     group assignment. The primary goal of this pilot is to determine the feasibility of~     recruiting and retaining study participants in anticipation of conducting a larger,~     multi-centered trial. However, the investigators will also obtain baseline data and follow-up~     measures at 6 weeks and 6 months after surgery. Outcomes will be assessed in several domains~     that the investigators hypothesize may be effected by oophorectomy: cardiovascular health,~     skeletal health, sexual functioning, and health-related quality-of-life.~   "
195283|NCT01007292|"~     The purpose of this study is to evaluate response rate, survival, safety and tolerability of~     YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.~   "
195284|NCT01007279|"~     An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after~     otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch~     occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after~     PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing~     obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent~     studies have suggested that pretreatment with Atorvastatin may be associated with a reduction~     in infarct size after elective PCI. (5-7 ).Actually the standard pretreatment in patients~     undergoing elective coronary-PCI and already treated with aspirin is copidogrel loading dose~     administration before procedure.(8,9 ) The investigators hypothesized that a high (40mg)~     loading dose of Rosuvastatin administered within 24h before the procedure may be effective in~     reducing the rate of periprocedural MI.Therefore, the investigators will conduct a single~     center,prospective randomized study to assess whether a single,high (40mg) loading~     (within24h)dose of Rosuvastatin is effective in preventing elevation of biomarkers of MI~     after elective coronary stent implantation.~   "
195285|NCT01007266|"~     Background:~        -  Type 2 diabetes mellitus (T2DM) is becoming more common among youth, particularly in~          minority populations. Few drug treatments are approved for T2DM in adolescents, and~          behavioral and lifestyle factors may contribute to their difficulties in following~          strict treatment regimens.~        -  It is unknown whether a minimally invasive patient partner ( buddy ) program, which has~          been developed to help improve diabetes control and quality of life, will be successful~          in a population of pediatric patients with T2DM.~      Objectives:~        -  To evaluate the effect of a minimally invasive intervention (being assigned a patient~          partner, or buddy ) on blood sugar levels in adolescents with T2DM.~        -  To assess changes between groups in body weight, number of home glucose monitor checks,~          compliance with medications, adherence to visit schedule, and psychological well-being.~      Eligibility:~      - Adolescents and young adults between 12 and 20 years of age who have been diagnosed with~     type 2 diabetes and whose blood glucose control needs improvement.~      Design:~        -  Participants will be divided by chance into two groups: in one group, participants will~          have a buddy and receive standard care; while in the other group, participants will~          receive standard care alone.~        -  The buddy is not a health care professional and is not authorized to provide any medical~          advice.~        -  Participants will be followed in the study for a total of 6 months. All study~          participants will receive standard treatment for T2DM.~        -  All patients will be asked to fill out a screening questionnaire (on paper or online) at~          the beginning of the study and a quality of life and eating behaviors questionnaire at~          the beginning and at the end of the study. These forms will include questions on medical~          history, emotions, well-being, and eating habits.~        -  Participants in both groups will have one diabetes clinic visit at the NIH Clinical~          Center or at Children s National Medical Center (CNMC) at the beginning of the study and~          two follow-up visits at the NIH or CNMC approximately 3 months apart. All visits include~          a physical examination, detailed medical history, and laboratory testing which is part~          of routine care for diabetes.~        -  Participants assigned to the buddy group will receive phone or online messages from the~          buddy once a week and will meet with the buddy once a month for less than 1 hour. The~          purpose of the in-person visit is to get to know each other better outside the usual~          hospital or clinic environment. The visits should take place at home, but may also take~          place elsewhere, for example, at schools, cafes, or libraries chosen by both the~          participant and the buddy. These face-to-face meetings may also take place at NIH or at~          CNMC if this is more convenient....~   "
195286|NCT01007253|"~     People who have hayfever or allergic rhinitis often complain about eye symptoms associated~     with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The~     purpose of this study is to better understand the generation of eye symptoms in patients with~     allergic rhinitis. We have previously shown that placing the substance that subjects are~     allergic to in their nose causes both nose and eye symptoms. This can be explain by a~     parasympathetic neurogenic reflex from the nose to the eye. Such a reflex would readily~     explain the tearing and watery eye symptoms, but does not explain the itch. In this study, we~     are going to address one possible explanation for the itch; does an axonal neurogenic reflex~     stimulate mast cells in the eye to release histamine, which then causes the itch? We will do~     this by placing an antihistamine drop in the eye and challenge the nose with allergen. We~     will also attempt to demonstrate that mast activation isn't effected by blocking the~     initiating of the reflex with a nasal steroid, as done in our previous study, and showing~     that the addition of an antihistamine does not add to the reduction of symptoms.~   "
195287|NCT01007240|"~     The aim of this study is to evaluate the antibacterial activity of crosslinked quaternary~     ammonium polyethylenimine (PEI) nanoparticles incorporated at 1-2% w/w in a commercial soft~     liner material when compared to the commercial soft liner material.~      The investigators' results in vitro showed a significant delay in bacterial growth.~      Therefore, the investigators assume to have the same delay in vivo- on patients.~   "
195288|NCT01007227|"~     Life-style intervention with dietetic and exercise therapy is an important fundamental~     approach to patients with metabolic syndrome (MetSyd) which may cause endothelial dysfunction~     leading to cardiovascular events. We investigated whether the life-style modification by~     dietetic and exercise instruction could improve endothelial dysfunction assessed by a new~     non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry~     (RH-PAT).~   "
195289|NCT01007214|"~     Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing~     prostatectomy.~   "
195308|NCT01006967|"~     The investigators are conducting a multi-central randomized prospective trial comparing a~     standard physical therapy gait and balance program with a gait and balance program that~     includes the ActiveStep™ treadmill.~      Subjects will be randomized to either have the ActiveStep™ as part of their therapy or to~     have their therapy without it. Data will be gathered from session notes, medical records and~     short interviews with the subjects at baseline and every 3 months over the telephone for the~     duration of the study.~   "
195309|NCT01006954|"~     About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to~     the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments~     have been suggested for increasing pregnancy rate. In this study, the investigators will~     compare the outcome of Microflare protocol and Flare up regimen in poor responders.~   "
195290|NCT01007201|"~     This is a laboratory-blinded study in healthy toddlers, children, and teenagers designed to~     investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1~     vaccine (AdimFlu-S). There are 3 age strata, and each contains at least 50 subjects: greater~     than or equal to 1 year to less than 3 years, greater than or equal to 3 years to less than 6~     years, and greater than or equal to 6 years to less than 18 years. In each age strata, all~     eligible subjects received 2 injections of AdimFlu-S (A/H1N1) at a designated dosage level~     (7.5 μg, 15 μg and 15 μg for 1~<3, 3~<6 and 6~<18 years, respectively) at 3 weeks apart.~      Following immunization, safety is measured by assessment of adverse events for 6 weeks~     following the first vaccination, serious adverse events and new-onset chronic medical~     conditions through 7 months post first vaccination, and reactogenicity to the vaccines for 7~     days following each vaccination. Immunogenicity testing includes hemagglutination inhibition~     (HAI) testing on serum obtained before first vaccination, and three and six weeks after first~     vaccination.~   "
195291|NCT01007188|"~     The U.S. Department of Agriculture (USDA) wants to learn more about the number of calories in~     almonds and the mechanisms of the health effects of almonds. Epidemiologic studies have~     demonstrated an inverse or no relationship between nut consumption and body weight, despite~     the fact that nuts are an energy dense food. Intervention studies have shown that consumption~     of nuts has no effect on body weight or an effect that is significantly less than predicted.~     Fecal analyses in studies with peanuts, almonds, and pecans have found increased fecal fat~     and energy loss with nut consumption; however studies with almonds are lacking.~   "
195292|NCT01007175|"~     This primary purpose of this study is to evaluate the safety, tolerability, and~     pharmacokinetic properties of multiple ascending doses of ATN-103 administered subcutaneously~     (below the skin) to Japanese subjects with active rheumatoid arthritis and on a stable~     background of methotrexate. Some subjects will receive ATN-103 while other subjects will~     receive a placebo.~   "
195293|NCT01007162|"~     To explore issues patient experience and satisfaction with a sample of patients recently~     discharged from critical care.~   "
195294|NCT01007149|"~     This study will assess the change in the expression of FcεRI receptors of blood basophils and~     dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in~     adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal~     therapy.~   "
195295|NCT01007136|"~     The purpose is to determine whether application of a non-invasive battery powered device~     called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness~     after stroke beyond what is achievable with rehabilitative treatment alone.~   "
195296|NCT01007123|"~     The purpose of this trial is to determine the efficacy and safety of A3309 administered to~     patients with chronic idiopathic constipation.~   "
195297|NCT01007110|"~     DHA, a type of fatty acid, is important in early development, both in terms of reproductive~     physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA~     has been shown to lower triglycerides and is important to cardiovascular health and autonomic~     control, lowering heart rate and blood pressure and increasing heart variability. Little is~     known about how fatty acids impact cardiac control in infants, children or the fetus. Our~     hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase~     fetal HRV.~   "
195298|NCT01007097|"~     The purpose of this study is to determine the safety and efficacy of multiple doses of~     TAK-875, once daily (QD), in subjects with Type 2 Diabetes Mellitus.~   "
195299|NCT01007084|"~     The purpose of this study is to determine whether propranolol can decrease pain symptoms in a~     common subset of patients admitted to a trauma center after injury.~   "
195300|NCT01007071|"~     Patients with Growth hormone (GH) deficiency often report impaired quality of life and~     difficulty with mental functioning. It has been suggested that GH replacement in such~     patients leads to improvement in cognitive function. The aim of this study is to elucidate~     the effects of GH replacement in patients with GH deficiency on cognitive function using~     structural and functional neuroimaging and cognitive testing.~   "
195301|NCT01007058|"~     The goal of this laboratory research study is to see if researchers can predict whose cancer~     will stay in remission and whose will return in patients receiving treatment for bladder~     cancer.~   "
195302|NCT01007045|"~     Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care~     for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as~     Well's criteria, D-dimer blood testing, and Radiology department ultrasound.~      The purpose of this study is to determine whether Emergency Physicians can safely rule out~     deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency~     department bedside ultrasound.~   "
195303|NCT01007032|"~     In this study, patients will initially receive intravenous (I.V.) IMC-A12 every 2 weeks or~     every 3 weeks for 6 weeks (one cycle). After the first cycle, patients experiencing a best~     overall response of complete response, partial response, or stable disease will continue to~     receive IMC-A12 at their cohort dose and schedule until there is evidence of progressive~     disease (PD), or until other withdrawal criteria are met. Patients will be enrolled at one~     study center, located in the National Cancer Center Hospital - East, Kashiwa, Japan.~     Approximately 20-30 patients are anticipated.~   "
195304|NCT01007019|"~     First in human study~   "
195305|NCT01007006|"~     The objective of this study is to evaluate whether use of TRMDU in addition to medication~     review leads to improved outcomes and reduced health care costs for patients when compared~     with medication review alone. The study will be conducted in patients assigned to Department~     of Defense (DOD) Warrior Transition Units (WTU's), similar DOD units, and VA polytrauma~     centers.~   "
195306|NCT01006993|"~     To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic~     stroke patients following administration of intravenous tPA.~   "
195310|NCT01006941|"~     The hypothesis of this study is that treatment with Trichuris suis ova will be safe and~     effective as an oral treatment of patients with relapsing multiple sclerosis.~   "
195312|NCT01006915|"~     The purpose of the study is to determine whether or not surgical decompression of the common~     peroneal, tibial, and deep peroneal nerves in the legs of persons with diabetic peripheral~     neuropathy is effective treatment.~   "
195754|NCT01001091|"~     The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment~     of the signs of inflammation associated with allergic conjunctivitis.~   "
195314|NCT01006889|"~     The primary aim of the study is to determine the impact on hepatic steatosis of replacing~     premeal rapid-acting insulin for exenatide (Byetta) while maintaining bedtime long-acting~     detemir (Levemir) insulin in well-controlled patients with type 2 diabetes mellitus (T2DM)~     and nonalcoholic fatty liver disease (NAFLD).~      Secondary aims are to learn: 1) the efficacy and safety of such approach and whether it is an~     acceptable treatment strategy compared to intensified insulin therapy alone; 2) mechanisms of~     action (effects on insulin secretion and insulin action); 3) its impact on weight (can it~     prevent insulin-associated weight gain or cause weight loss) and rates of hypoglycemia; 4) if~     it may improve specific plasma biomarkers of disease activity in NAFLD and inflammatory~     markers common to both conditions - T2DM and NAFLD (hsCRP, ICAM, VCAM).~   "
195315|NCT01006876|"~     This study aims to explore the risk of periprocedural thromboembolic events in continuous~     versus interrupted Coumadin therapy in a large, randomized high-risk patient population~     undergoing radio-frequency catheter ablation for atrial fibrillation.~   "
195316|NCT01006863|"~     The prophylactic use of small doses of ephedrine may be effective in obtunding of the~     hypotension responses to propofol with minimal hemodynamic and ST segment changes. The~     investigators aimed to evaluate the effects of small doses of ephedrine on hemodynamic~     responses of propofol anesthesia for valve surgery.~      There is widespread interest in the use of propofol for the induction and maintenance of~     anesthesia for fast track cardiac surgery. However, its use for induction of anesthesia is~     often associated with a significant rate related transient hypotension for 5-10 minutes. This~     is mainly mediated with decrease in sympathetic activity with minor contribution of its~     direct vascular smooth muscle relaxation and direct negative inotropic effects.~      Ephedrine has demonstrated as a vasopressor drug for the treatment of hypotension in~     association with spinal and general anesthesia. Prophylactic use of high doses of ephedrine~     [10-30 mg] was effective in obtunding the hypotensive response to propofol with associated~     marked tachycardia. However, the use of smaller doses (0.1-0.2 mg/kg) was successfully~     attenuated, but not abolished, the decrease in blood pressure with transient increase in~     heart rate. This vasopressor effect is mostly mediated by β-stimulation rather than~     α-stimulation and also indirectly by releasing endogenous norepinephrine from sympathetic~     nerves.~      Because the effect of decreasing the dose of ephedrine from 0.1 to 0.07 mg/kg may be~     clinically insignificant, the investigators postulated that the prophylactic use of small~     dose of ephedrine may prevent propofol-induced hypotension after induction of anesthesia for~     valve surgery with minimal in hemodynamic, ST segment, and troponin I changes.~      The aim of the present study was to investigate the effects of pre-induction administration~     of 0.07, 0.1, 0.15 mg/kg of ephedrine on heart rate (HR), mean arterial blood pressure (MAP),~     central venous and pulmonary artery occlusion pressures (CVP and PAOP, respectively), cardiac~     (CI), stroke volume (SVI), systemic and pulmonary vascular resistance (SVRI and PVRI,~     respectively), left and right ventricular stroke work (LVSWI and RVSWI, respectively)~     indices, ST segment, and cardiac troponin I (cTnI) changes in the patients anesthetized with~     propofol-fentanyl for valve surgery.~   "
195317|NCT01006837|"~     The purpose of this study is to analyze changes in core body- and skin temperature during~     pre-hospital and early in-hospital treatment of multi-traumatized patients. The researchers~     want to investigate when trauma patients get cold and to what extent.~   "
195318|NCT01006824|"~     This study compares wireless capsule endoscopy (patients swallow a pill-size camera that~     sends pictures of the intestine to a recorder worn on their belt) to an x-ray study (called~     dedicated small bowel contrast radiography) in patients who have bleeding from the~     gastrointestinal tract without a source of the bleeding identified on routine endoscopic~     examinations of the esophagus (food pipe), stomach, small intestine, and large intestine.~      The investigators hope to determine if the capsule is a better test in terms of decreasing~     further bleeding, decreasing the need for further diagnostic testing, and decreasing the need~     for blood transfusions and time spent in the hospital.~   "
195319|NCT01006811|"~     Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young~     children. The ketogenic diet has been shown to be very effective in these children. The~     modified Atkins diet is a less restrictive option than the ketogenic diet, which has been~     effective in preliminary studies on refractory epilepsy in children, adolescents and adults.~     Modified Atkins diet may be of special importance in infants, as proteins are not restricted,~     hence no problems with growth are expected. Hence this pilot study has been planned to~     evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms~     refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).~   "
195320|NCT01006798|"~     The purpose of this study is to compare the safety and immunogenicity over a 9-month period~     of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of~     the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in~     all Household Contacts residing with the vaccinated volunteers.~      Vaccinees also may participate in a substudy in which they receive a booster vaccination with~     the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).~   "
195321|NCT01006785|"~     The purposes of this study are :~        -  to investigate the safety and clinical efficacy of sole therapy with DLBS1425 in~          suppressing disease-(tumour) progression in subjects with advanced/metastatic breast~          cancer; and~        -  to determine the minimal effective and safe dose of DLBS1425 in the therapy of~          advanced/metastatic breast cancer~   "
195322|NCT01006772|"~     Stroke is a major cause of disabilities worldwide. Stroke survivors commonly exhibit walking~     defects which lead to an altered, slow speed and asymmetric gait pattern. The main aims of~     rehabilitation are to enhance recovery of movement control and regain walking ability.~     Ankle-foot orthoses (AFOs), braces which encompass the foot and ankle joint extending to a~     point below the knee, are commonly prescribed to address ambulation impairments in stroke~     patients. Their main function is to support the foot and allow a subject to walk safely with~     a gait approaching normality. This project will aim to evaluate the early provision of AFOs~     as an adjunct to standard physiotherapy on the walking ability of stroke survivors. Usual~     rehabilitation practice will be the control condition. Participants will be recruited from~     the stroke unit of Stobhill Hospital in Glasgow. They will be randomised into two groups.~     Participants allocated in the control group will receive usual clinical practice as per~     routine for stroke patients. The intervention group will receive custom made solid AFOs as an~     adjunct. They will be provided with three AFOs, one for use during rehabilitation and two~     which will be used only during the outcome assessment sessions for research purposes. The~     intervention phase will last 24 weeks. Gait analysis will be performed three times for each~     participant (at baseline, 12 and 24 weeks after enrolment) in the biomechanical laboratory of~     Strathclyde University. During these sessions force and movement data of patients walking~     will be recorded. Fortnightly time and distance factors of gait will be measured and a~     battery of functional tasks will be performed in the physiotherapy gym of the hospital using~     a simple video camera and a grid lino-mat. During all assessments participants with an AFO~     will be asked to walk with and without the AFO provided.~   "
195323|NCT01006759|"~     Leprosy is an infectious disease of slow evolution, manifested primarily by signs and~     symptoms dermatoneurological with skin lesions and peripheral nerve, especially in the eyes,~     hands and feet. The prevention of disability is essential for the control of complications.~     Objective: To evaluate the physical and functional status of hands, feet and eyes, for the~     appearance and evolution of sensory and motor deficiencies and classification of disability~     (WHO) of a group of leprosy patients to compare and monitor the result treatment on the~     progression of neuropathy and recurrence of reactions. Methodology: We performed initial~     physical therapy evaluation and final, after 12 months. We conducted a clinical trial of a~     series of 26 cases evaluated with newly diagnosed leprosy, treated by standard medication.~     There were used methods of qualitative and quantitative. An illustrated manual of guidelines~     was especially developed for this study.~   "
195325|NCT01006733|"~     Blood clots contribute to the death of at least 100,000 Americans each year. Because many of~     these deaths occur suddenly where treatment is impossible, the best treatment is prevention.~     With this grant, researchers in Missouri, New York, Utah, Illinois, and Texas are developing~     strategies to improve the safety and effectiveness of clot prevention by customizing a~     popular blood thinner (warfarin) to each person's genetic and clinical profile. They~     hypothesize that the use of genetics to guide warfarin therapy will reduce the risk of venous~     thromboembolism (VTE) postoperatively. They further hypothesize that using a target~     international normalized ratio (INR) of 1.8 is non-inferior to using a target INR of 2.5 in~     VTE prevention.~   "
195326|NCT01006720|"~     This study is designed to compare recovery times after reversal of a residual neuromuscular~     block (TOF-ratio 0.2) with different doses of either neostigmine or sugammadex.~   "
195327|NCT01006707|"~     Opioid medications are commonly used for pain relief. When given over time, physical~     dependence can occur. This results in unpleasant side effects--such as agitation and~     nausea--if opioid medications are suddenly stopped. However, we do not know how withdrawal~     affects the brain. We know that a medication named Ondansetron can help ease or prevent~     symptoms associated with opioid withdrawal. Through imaging of the brain by fMRI, we hope to~     see how opioid withdrawal, with and without the administration of ondansetron, affects brain~     activity.~   "
195328|NCT01006694|"~     Trained para-professional health care workers will implement a stepped-care model of~     depression care in commune health stations in Vietnam.~   "
195329|NCT01006681|"~     The spread of Influenza H1N1 has prompted the development of vaccines against this virus.~     Immunocompromised patients are at increased risk of developing complications of Influenza~     H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population~     of patients.~   "
195330|NCT01006668|"~     Endotracheal intubation is a painful and stressful procedure, which is associated with acute~     increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with high~     morbidity.~      The aim of the study is to compare recovery time, efficacy and tolerance in a randomized~     controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal~     Intensive Care Unit.~   "
195331|NCT01006655|"~     Respiratory diseases including Asthma are high prevalent among preschool children. Specific~     treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the~     amount of the drug reaching small airways and lungs is bigger how much smaller the particles~     liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately~     emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg,~     that is supposed to reach the small airways at higher concentrations and be more suitable to~     patients who don't cooperate properly to the procedure of inhalation.~      The investigators' group has reported successfully the possibility to perform Pulmonary~     Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported~     relation between asthma control and reduction in airway hyperreactivity. The purpose of this~     study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways~     hyperreactivity in preschool children, as demonstrated by adenosine challenge test.~   "
195332|NCT01006642|"~     There has been recent interest into the potential role of mucosal barrier defects in the~     pathophysiology of functional gastrointestinal disorders (FGIDs). There has been evidence of~     increased intestinal permeability in patients of IBS,and abnormal tissue resistance in NERD.~     Although the mucosa of Functional dyspepsia (FD) patients is endoscopically and~     histologically normal, it contains ultrastructural changes, activated immune cells, along~     with evidence of an increased release of mediators leading to gastric dysfunction. There is~     now consistent evidence indicating that mucosal barrier defects allow the passage of an~     increased load of bacteria, antigens and toxins which, in turn evoke activation of mucosal~     immune responses involved in the FD symptom.~   "
195333|NCT01006629|"~     100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or~     with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as~     prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the~     safety and efficacy of the drug in Russian subjects.~   "
195334|NCT01006616|"~     Neutrophils are thought to play an important role in the pathophysiology of chronic~     obstructive pulmonary disease (COPD). Navarixin (SCH 527123, MK-7123) is an antagonist of the~     cysteine-X-cysteine chemokine receptor 2 (CXCR2) and is thought to reduce neutrophil~     migration to the diseased lung. It is theorized that reducing neutrophil migration to the~     diseased lung will improve a participant's symptoms and the natural history of the disease.~      The study will consist of a 2-week screening period followed by a 2-year (104-week)~     double-blind treatment period. The 2-year Treatment Period will be made up of two phases: a~     26-week (6-month) dose range-finding phase with 3 active arms and 1 placebo arm (Period 1),~     followed by a 78-week (18-month) long-term safety and efficacy phase (Period 2). Participants~     participating in the original 6-month study (Period 1) may elect not to continue into the~     18-month extension study (Period 2).~      Hypothesis: navarixin, 50 mg, or the highest remaining dose if the 50-mg dose is~     discontinued, is superior to placebo with respect to improving airflow.~   "
195335|NCT01006603|"~     This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride~     in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on~     metformin monotherapy.~   "
195336|NCT01006590|"~     The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration~     of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a~     submaximal dose of metformin.~   "
195337|NCT01006577|"~     Primary hypothesis: Side-to-end anastomosis is non-inferior to colon J pouch for~     reconstruction after low anterior resection for rectal cancer in fecal incontinence (Wexner~     score).~      Research questions: Are there differences between side-to-end anastomosis and colon J pouch~     in~        -  bowel function (fecal incontinence, frequency of bowel movements, rectal urgency,~          incomplete evacuation)~        -  quality of life~        -  sexual function~        -  urinary function~        -  postoperative complications~        -  operation time/ institutional costs~   "
195338|NCT01006564|"~     To determine if functional MRI methods will aid planning of a radiation dose boost within the~     prostate in patients with prostate cancer potentially improving safety and efficacy.~   "
195339|NCT01006551|"~     This is an open trial of ziprasidone (ZIP) in children and adolescents. It is designed to~     provide pilot data on the magnitude of ZIP's antipsychotic effects in psychotic youth, dosing~     ranges, acute safety, and tolerability. This would then inform the design of a rigorous,~     randomized controlled trial of ZIP in the pediatric population. The primary study hypothesis~     is that the proportion of pediatric subjects responding to treatment with ziprasidone will be~     comparable or greater than reported in trials of ziprasidone in adults.~   "
195340|NCT01006538|"~     Wet age-related macular degeneration is the most common cause of blind registration in the~     UK. Standard treatment involves regular eye injections of a drug called ranibizumab~     (Lucentis). For most patients, ranibizumab maintains their vision but the effect of the drug~     is temporary, and they therefore require monthly hospital visits and typically six injections~     into the eye every year, probably for life.~      This study tests a new surgical device that delivers a focal dose of radiation (epimacular~     brachytherapy) to the macula (the part inside the back of the eye that gives fine central~     vision), to try and reduce or eliminate the need for ongoing, regular eye injections. The~     trial compares epimacular brachytherapy to ongoing standard treatment with ranibizumab.~      Whereas most studies of this new surgical device target patients who have not yet commenced~     any treatment, this study targets those who are requiring frequent eye injections, as there~     are limited surgical resources and these resources are best directed to those who have not~     fully responded to ranibizumab therapy, or whose response is shortlived. These patients have~     the most to gain from a device that may reduce their burden of treatment. The findings in~     untreated disease cannot be extrapolated to this discrete subset of patients, hence the need~     for a study that targets refractory disease.~      It is hypothesised that epimacular brachytherapy will reduce the frequency of Lucentis®~     (ranibizumab) re-treatment that patients require, whilst maintaining visual acuity.~   "
195341|NCT01006525|"~     The purpose of the study is to determine how safe and effective it is for people with~     insomnia to use zolpidem on a nightly basis for one year.~   "
195342|NCT01006499|"~     The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG~     or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.~   "
195343|NCT01006486|"~     A clinical trial designed to compare the oral anticoagulation control obtained by an~     anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.~   "
195344|NCT01006473|"~     The benefits of exercise training in heart failure are well established. Its effects,~     however, have not been evaluated in Chagas cardiomyopathy (ChC). The investigators hypothesis~     is that the exercise training may improve functional capacity, quality of life (QoL), and~     reduce brain natriuretic peptide (BNP) levels in patients with ChC.~   "
195345|NCT01006460|"~     This is clinical trial to document the efficacy of a proprietary standardized extract of~     Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an~     every day consumer perspective to ameliorate mild depression, reduce stress and improve~     quality of life. A newly developed adaptogenic formulation, Adapt 232, was included into the~     study in order to evaluate its effect in comparison to the others.~   "
195346|NCT01006447|"~     This randomized field trial uses a self-report daily exercise log to answer the research~     question: Does frequency of instruction influence tai chi/qigong home practice exercise~     persistence among residents of Senior housing?~   "
195347|NCT01006434|"~     Thrombolysis using Alteplase (tPA) is still the only approved specific therapy for acute~     ischemic stroke (AIS). Current guidelines in western countries recommend an tPA dose of~     0.9mg/kg up to a maximum dose of 90mg for patients weighing more than 100kg. However, larger~     dose-finding rtPA trials for intravenous thrombolysis in AIS are missing. Based on results~     from research on myocardial infarction only a few open label studies with low case rates were~     initiated to evaluate the optimal dose for tPA in cerebral ischemia. These studies suggested~     a narrow therapeutic range with decreased efficacy in lower dosages and an increased risk for~     thrombolysis related intracerebral hemorrhage (ICH) at doses above 0.95mg/kg. The ECASS-1~     trial which used a dosage of 1.1mg/kg rt-PA showed significantly higher rate of large~     parenchymal hemorrhages compared to trials using 0.9mg/kg. Therefore accurate dosing is~     crucial. In the acute phase two aspects complicate rtPA dosing in AIS: First, unlike in other~     diseases many stroke patients are unable to communicate information on their body weight (BW)~     because of their stroke symptoms (e.g. aphasia, decreased consciousness). In addition motor~     symptoms prohibit easy weighing procedures in many patients. Second, the ultra-early and~     narrow time window for treatment does not allow time loss to weigh each patient in the~     emergency situation. Therefore routinely the attending physician has to make a visual~     estimation of the patient's BW. This may be inaccurate and may cause dosing errors which has~     been shown for other weight based emergency medication. There is little data on tPA-dosing~     errors in stroke patients and prospective data are lacking. The aim of our study is to~     evaluate availability of BW-information, accuracy of estimations and final dosing of tPA in a~     routine clinical setting. Therefore the investigators evaluate different sources of body~     weight estimations and also compare visual estimation with recently proposed anthropometric~     measurements for body weight approximation. Finally, impact of dosing errors on safety and~     efficacy are analyzed.~      The initial phase will consist of 100 enrolled patients as a pilot phase for further power~     calculations. Based on the results of the pilot phase enrollment will continue. The~     envisioned inclusion target is up to 800 patients.~   "
195348|NCT01006421|"~     Vitiligo is a common chronic skin disease with 1-4% prevalence. It has a significant~     psychosocial impact on patients and society. Different treatment modalities with variable~     success rates are available.~      Phototherapy is among the successful treatments but gives modest results. Some reports~     documented the usefulness of Ginkgo Biloba (GB) when used alone in Vitiligo treatment.~   "
195349|NCT01006408|"~     The purpose of this research study is to determine if treatment with Low Level Laser Therapy~     (LLLT) is effective in treating the pain, numbness or tingling patients are experiencing~     following their chemotherapy. The investigators would also like to know the number of~     treatments that were needed in order to reduce their symptoms.~   "
195392|NCT01005849|"~     The present study is designed to evaluate the effect of a mixture of probiotics on the~     prevention of traveler's diarrhea (TD) in subjects who travel to a country with a high risk~     for developing TD. Subjects will be asked to take one capsule containing a mixture of~     probiotics or a placebo capsule a day, within the week before departure, during the travel~     and up to 3 days after return. They will note the following outcomes in a diary: occurence of~     diarrhea, number and consistency of stools, duration of the diarrhea, presence of~     diarrhea-related symptoms and need for rescue medication.~      The present study will examine if the use of the probiotics capsule reduces the occurence of~     traveler's diarrhea as compared to the placebo capsule.~   "
195472|NCT01004796|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at tissue samples from patients with breast cancer.~   "
195350|NCT01006395|"~     Less than 20% of men in whom prostate cancer is diagnosed early die from it. Cardiovascular~     disease is the most common cause of death in men with early prostate cancer. A commonly used~     form of treatment for prostate cancer is androgen deprivation therapy (ADT). ADT, while~     effective for the treatment of prostate cancer, has been linked to undesirable side effects,~     such as an increased risk of bone fractures and diabetes. Bisphosphonates, a class of drugs~     that prevent bone resorption, have been show to reduce the loss of bone mineral density that~     occurs as a consequence of ADT, but the effects of bisphosphonates on preservation of bone~     architecture is unknown.~      This project has two main goals:~      To assess prospectively, in men with prostate cancer receiving ADT, the effect of:~        1. the intravenous bisphosphonate zoledronic acidon ADT-induced microarchitectural decay of~          bone structure.~        2. ADT on insulin resistance and glucose metabolism. We will recruit 100 ambulatory men~          with non-metastatic prostate cancer who are about to commence a three year course of ADT~          as per routine clinical practice at Austin Health. Men will be randomised to receive~          either intravenous zoledronic acid (Aclasta, Novartis Pharmaceuticals) or placebo at~          baseline and after 12 months of ADT. Men with contraindications to zoledronic acid will~          be excluded from the study. All 100 study subjects will have clinical and laboratory~          assessment at baseline, and at 3, 6, 12, 18 and 24 months (study end), and imaging~          studies at baseline and at 6, 12 and 24 months.~      The study protocol is outlined in more detail below (Please see flow chart included in the in~      PICF):~      Clinical and laboratory assessment:~      Full medical history, physical examination and quality of life assessment using the SF-36~     questionnaire. Laboratory studies will include: oral glucose tolerance test (3, 12 and 24~     months Commercial-in-Confidence only) and measurements of measure total testosterone, fasting~     glucose, C-peptide, HBA1c, bone turnover markers.~      Imaging studies:~        1. Bony micro-architecture by high resolution quantitative computed tomography~        2. Bone mineral density and body composition by DEXA This project will have no direct~          benefit for the subjects involved in this study; however, it will improve our~          understanding on the effect of zoledronic acid on bone microarchitecture in men with~          prostate cancer receiving ADT. It will also help us to better understand the effect of~          ADT on insulin resistance and glucose metabolism.~   "
195351|NCT01006382|"~     Anaphylaxis is a severe and potentially life threatening allergic reaction which can affect~     the airway, breathing and/or circulation. This reaction can be triggered by a number of~     different allergens but the most common are food, medications, insect venom and latex.~     Because these reactions occur suddenly and are potentially very serious, the best management~     lies in the correct use of the prescribed emergency medication. Epinephrine, or adrenaline as~     it is more commonly known, is the recommended drug for the treatment of anaphylaxis.~     Injecting the epinephrine into the outer thigh muscle is the preferred route of~     administration. For health professionals, patients and carers, this rapid administration is~     facilitated by the manufacture of preloaded syringes and autoinjectors. Despite the~     availability of these devices, a review of studies shows poor knowledge and skills amongst~     both health professionals and patients with regards to using autoinjectable epinephrine~     devices correctly. These studies found that as well as poor knowledge in using the~     autoinjectors, there was a lack of confidence amongst patients and an unwillingness to carry~     the device with them at all times.~      In other disease groups like asthma and diabetes, psychological models which involve asking~     people how they think about their illness and their related behaviours, have been found to~     help in the understanding of why some people follow or adhere to health professionals advice~     and why others do not. Based on these findings, this study will look at two appropriate~     psychological models and their ability to predict variation in adherence to self-care~     regimens in adolescents and young adults with food allergy related anaphylaxis.~   "
195352|NCT01006369|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Hydroxychloroquine may help~     chemotherapy and bevacizumab work better and kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving hydroxychloroquine together with~     capecitabine, oxaliplatin, and bevacizumab works in treating patients with metastatic~     colorectal cancer.~   "
195353|NCT01006356|"~     The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride~     (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency~     for the management of breakthrough pain after the administration of hydromorphone HCl OROS in~     Korean cancer participants.~   "
195354|NCT01006343|"~     The entire study protocol will last 13 weeks. Women will be randomly assigned to one of two~     experimental groups: high and low protein. All women will consume their unrestricted habitual~     diet during week 1 while baseline testing and measurements are taken. Starting at week 2,~     women in both groups will be counseled to consume a 750 kcal/day energy deficit diet~     containing either the RDA (LP group) or more than the recommended dietary allowance (RDA) (HP~     group) for protein. The energy restriction period will continue for 12 weeks (through study~     week 13) and is expected to result in body weight reduction of approximately 17 pounds.~     Testing and measurements will be repeated during week 13.~   "
195355|NCT01006330|"~     Dysphagia in hospitalized elders is associated with less positive outcomes in rehabilitation,~     increased likelihood of readmission, increased comorbidity and mortality, and increased~     length of hospital stay. In light of an increase in the elderly population in Denmark, the~     consequences of dysphagia, and the importance of minimizing the risk of disability and~     frailty, it is vital to emphasize safe participation of the elderly dysphagic patient in~     eating, drinking and swallowing. Danish occupational therapists have an important role in the~     dysphagia management, but no Danish evidence-based occupational therapy assessments for~     dysphagia of elderly medical patients exist. In order to oblige this lack, the objective of~     the study is to provide an assessment tool with operational definitions of dysphagia which~     includes the complexity of performance in eating, drinking and swallowing, is evidence-based,~     and guides occupational therapists in the treatment planning in a client-centred and~     purposeful manner.~      The study involves a quantitative approach, and is initiated by a translation and cultural~     adaptation of the Canadian The McGill Ingestive Skills Assessment (MISA). Hereafter, the~     psychometric qualities are tested. On basis of the data collected for the psychometrics, the~     prevalence and characteristics of dysphagia in the study population are investigated.~     Provided that the psychometric testing of the MISA reveals satisfactory levels, the effect of~     using the MISA in the treatment planning is investigated.~      It is hypothesized that:~      The Danish translation of the MISA will demonstrates satisfactory content validity,~     reliabilities, convergent validity, known-groups validity, predictive validity, criterion~     validity, high levels of sensitivity/specificity and are responsive to change.~      Dysphagia is prevalent in elderly medical patients at the time of admission to acute medical~     care and there can be found a correlation between dysphagia severity and the presence of~     comorbidity, disability, frailty, the length of hospital stay, the place of discharge and the~     number of readmissions for elderly medical patients.~   "
195395|NCT01005810|"~     This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will~     reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is~     hypothesized that marijuana dependent adolescents who are treated with NAC will use less~     marijuana during treatment when compared to adolescents who receive a placebo.~   "
195396|NCT01005797|"~     The purpose of this study is to determine if a new investigational drug called Panobinostat~     is safe, tolerable and to obtain an initial assessment of efficacy, when given in combination~     with Sorafenib for the treatment of certain types of lung cancer, kidney cancer and soft~     tissue sarcoma.~   "
195356|NCT01006317|"~     This project aims to strengthen and improve the performance of health care system in rural~     China in order to improve maternal and child health. It also provides policy-makers and~     health service managers with evidence for the development of informed policy on maternal and~     child health (MCH). The research focuses on women of reproductive age in rural areas of China~     as well as on their antenatal and obstetric care service providers, both clinicians and~     policy makers. For the Member States and China, as well as other countries it will provide a~     comprehensive analysis and synthesis of current state of affairs, provider and user~     perspectives, of antenatal and obstetric care in rural China at national and local level.~     This study seeks to assess whether improving financial accessibility to and quality of~     maternal health care increase use of and impact of maternity services. This project is~     implemented in 3 provinces: Anhui, Shaan'xi and Chongqing. This project will provide a~     practical example and information on impact of abolishing user fees on MCH service~     utilisation and develop and disseminate evidence-based policy recommendations on how to~     improve access to and quality of antenatal and obstetrical care for local and central~     government and international organisations, and thus serve as a step toward reaching such~     important goals.~      CHIMACA includes 3 types of interventions, two behavioural interventions and financial~     intervention. Behavioural interventions are training for clinical skills and training health~     education.~   "
195357|NCT01006304|"~     This exploratory study will use a thermal-grill experimental model to assess the effects of~     JNJ-39439335 (50 mg, single oral dose) on the relief of pain.~   "
195358|NCT01006291|"~     This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical~     trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients~     with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should~     continue their current OAD treatment at the stable, prerandomisation dose level and dosing~     frequency.~   "
195359|NCT01006278|"~     This investigation describes a novel complex of structural degradation proteins that is~     associated with pain in individuals with meniscal pathology undergoing arthroscopic partial~     meniscectomy. The presence of the complex in the synovial fluid of the knee is sensitive and~     specific for the painful state compared with similar aged controls. The absence of the~     complex in asymptomatic controls makes it a useful biomarker for the disease state.~   "
195360|NCT01006265|"~     This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with~     relapsing-remitting multiple sclerosis.~   "
195361|NCT01006252|"~     The primary purpose of this study is to see how tasisulam affects metastatic melanoma when~     compared against paclitaxel as measured by overall survival.~   "
195362|NCT01006239|"~     The investigators propose to establish a Biorepository of both diseased and normal tissue~     collected from subjects undergoing surgery for solid tumor resection. In cooperation with the~     Scripps Cancer registry, the investigators will also establish an anonymized database of~     corresponding clinical information including response to treatment, disease status, and~     recurrence.~      The Biorepository for Scripps Health will be able to process, preserve, and distribute~     samples to scientific and medical researchers at Scripps.~   "
195363|NCT01006226|"~     The purpose of this study is to determine:~        -  Whether bevacizumab increases the amount of oxygen in cancer as measured by a special~          positron emission tomography (PET) scan using 64Cu-ATSM.~        -  Whether the amount of oxygen in cancer as measured by 64Cu-ATSM PET scan predicts how~          well the cancer responds to treatment with chemotherapy.~   "
195364|NCT01006213|"~     Overall mortality, such as that caused by cardiovascular disease, increases as weight~     increases. In the Framingham Study, it was shown that obesity is a cardiovascular risk factor~     independent of other risk factors such as type 2 diabetes mellitus, dyslipidemia and smoking.~      Objectives:~        1. To determine whether a group motivational intervention is more effective than the~          standard intervention for treatment of overweight and obesity and most importantly to~          maintain the attained weight loss on a permanent basis.~        2. To assess whether this intervention is more effective than reducing cardiovascular risk~          factors (lipid profile, apo B-100, apo A-1, fibrinogen, C-reactive protein,~          hypertension, diabetes mellitus) associated with overweight and obesity, and the overall~          cardiovascular risk in these patients.~      Design: Randomized, multicenter, interventional clinical trial in patients with overweight~     and obesity. Randomized assignment of the intervention by Basic Health Areas (BHAs). Two~     groups will be established in geographically separate areas, one of which will receive the~     group motivational intervention (intervention group) and the other will receive standard~     follow-up (control group). BHAs located in the same building will be assigned the same group~     (control or intervention) to avoid potential contamination. hypertensive treatment or with a~     diagnosis of hypertension in their clinical history.~      Study Scope: Primary care. The study will be conducted in 24 BHAs of Hospitalet de Llobregat~     and Barcelona during 26months follow-up period. Haematic analyses will be in the carried out~     at the reference laboratory.~   "
195365|NCT01006200|"~     This study is aimed to determine factors leading to obstructive granulation tissue formation~     after placement of Self-Expandable Metallic Stent (SEMS) in patients with benign tracheal~     diseases.~   "
195366|NCT01006187|"~     The purpose of this study is to compare four different analgesic strategies in adults~     undergoing routine influenza immunization~   "
195367|NCT01006174|"~     The purpose of this research study is to determine how dietary fats and oils influence the~     absorption of beneficial plant pigments (carotenoids) from vegetables. The study will examine~     changes in blood carotenoids in response to eating a salad with different fats/oils.~   "
195368|NCT01006161|"~     Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation,~     there is a theoretical reason for its use in patients with severe asthma where neutrophils~     are thought to play a significant role in the pathophysiology of the disease.~   "
195397|NCT01005784|"~     This is a comparison of pregnancy achievement between two GnRH antagonist protocols which~     differ in the timing of GnRH antagonist initiation.~   "
195398|NCT01005771|"~     This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.~   "
195473|NCT01004783|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This clinical trial studies biomarkers in tumor tissue samples from young patients~     with very low risk Wilms tumors.~   "
195369|NCT01006148|"~     In this study we want to compare the effectiveness of a bone substitute (Allogenix Plus, a~     product derived from a dead human being that has chosen to donate it prior to dying) and bone~     dust from the patient's own bone pieces, versus bone dust alone in filling in the gaps that~     sometimes occur after surgery for craniosynostosis . We will compare the percent of defect~     filled at 1 year in 5 patients 18 months or older with metopic craniosynostosis that received~     the bone substitute plus their bone dust with 5 previously operated patients with similar~     characteristics that received bone dust alone to fill in the gaps. The bone substitute that~     we are using will be provided at no cost by the company Biomet Microfixation. The bone~     substitute Allogenix Plus undergoes extensive screening for infectious diseases as well as~     processing to prevent a rejection. The product will be applied during standard surgery to 5~     patients with metopic craniosynostosis of 18 months or older with skull defects no larger~     than 25 cm2, so it does not require any additional surgeries. Aside from the placement of~     this bone substitute the patient will proceed to receive the standard of care which includes~     a pre-operative CT scan, immediate post-operative CT scan, and 1 year post-operative CT scan~     of the Head. We will review these scans and look at percent of bony growth in the bone~     substitute plus bone dust group . We will also see the patients in clinic, during standard of~     care follow-up visits at 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months, and 1 year~     post-operatively. During clinic visits we will monitor the patient closely for any potential~     side effects of the bone substitute as well as complications of the surgery. We will then~     review the charts of 5 patients 18 months or older that have undergone surgery for metopic~     craniosynostosis until 5 patients with similar characteristics and defect size have been~     obtained. We will compare their post-operative CT scans and pictures and we will look at bone~     growth, bone resorption, bone gaps present, and need for secondary surgeries.~   "
195370|NCT01006135|"~     The objective of this observational study is to collect and evaluate data on Health Related~     Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in~     the national samples of Central & Central European patients with varying severities of~     chronic obstructive pulmonary disease (COPD) in the real life setting over the 6 months.~   "
195371|NCT01006122|"~     Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a~     histaminergic agent which therefore may improve alertness and awakeness in patients with~     excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS~     when treated with this compound compared to placebo in patients with narcolepsy is~     hypothesized.~   "
195372|NCT01006109|"~     Background:~      - Most of the time, humans make decisions according to their consequences, especially if they~     will be beneficial, and will avoid or try to avoid doing an action if it has a bad outcome.~     The way that the brain prepares a movement has been studied in detail, but the way the brain~     makes decisions before carrying out an action is still poorly understood. Researchers are~     interested in learning more about the decision-making process and how it affects the brain.~      Objectives:~      - To record the activity of the brain during decision-making processes.~      Eligibility:~      - Healthy, right-handed volunteers between 18 and 40 years of age.~      Design:~        -  Potential participants will have a screening visit with a medical history and~          neurological examination to determine eligibility.~        -  This study requires seven visits: one magnetic resonance imaging (MRI) visit and 6~          magnetoencephalography (MEG) recording visits. The MEG recording visits will include~          transcranial magnetic stimulation (TMS). All visits will be spaced at least 1 week~          apart. Total participation will last about 6 weeks.~        -  Participants will have an MRI scan at the first study visit.~        -  The MEG procedures will record brain activity during a series of computer tests~          involving winning or losing money. TMS will be performed during these visits, separate~          from the test....~   "
195373|NCT01006096|"~     The purpose of this study is to determine whether erlotinib is effective in the treatment of~     psoriasis.~   "
195374|NCT01006083|"~     The objective of this study is to evaluate the safety of antiplatelet (APA)therapy~     continuation in patients undergoing lumbar spine surgery (laminectomy, discectomy and~     foraminotomy), and to gather evidence-based data regarding postoperative outcomes potentially~     related to APA management.~   "
195375|NCT01006070|"~     The purpose of this study is to create a prospective database of patients with myeloma~     affecting the spine. This database will define changes in health-related quality of life over~     time, and the effect of incident fractures and their treatment on specific measures of pain,~     physical function, pulmonary function, and future fractures. In 2008, the UCSF Myeloma~     Service was actively caring for 347 patients with myeloma, of which 150 patients had lytic~     lesions on radiographs, and 100 had a known vertebral fracture. This population, as well as~     any new myeloma patients, will serve as the source of the study population.~   "
195376|NCT01006057|"~     This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the~     NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent~     that the dose should be adjusted in subjects with impaired renal function compared to the~     dose for subjects with normal renal function.~   "
195377|NCT01006044|"~     1. Primary outcome measure:~           a.Evaluation of the treatment impact on progression-free survival.~        2. Secondary outcome measures:~             1. Safety evaluation.~                  -  Direct effects attributable cell obtaining and administration.~                  -  Adverse events during treatment.~                  -  Neurological deterioration quantified using the NIH Stroke Scale.~                  -  Autoimmune phenomena.~             2. Evaluation of impact on other efficiency clinical parameters.~                  -  Overall survival.~                  -  Quality of life measured with EORTC questionnaire.~             3. Study of specific immune response and correlates with clinical outcome.~                  -  Delayed hypersensitivity.~                  -  Humoral response to autologous tumor cells/tumoral lysate.~                  -  Cellular response (proliferation, cytokine production, specific cytotoxicity).~             4. Cell line characterization and correlate the final product with clinical efficacy.~                  -  Phenotypic studies.~   "
195393|NCT01005836|"~     Structured, manualized treatments have been developed for numerous mental health problems and~     disorders among children and adolescents, and a number of these have shown strong beneficial~     effects in clinical trials. Such findings have led to proposals that the empirically~     supported treatments be used to improve outcomes of conventional clinic treatment, which some~     research suggests may not be very effective. But can these lab-tested treatments actually~     work in service-oriented clinics with referred youth? Available evidence cannot tell us,~     because the therapists, conditions, and clientele in the laboratory efficacy tests tend to~     differ so markedly from those of clinical practice. To assess the clinical potential of~     efficacy-tested treatments, we need effectiveness research that tests these treatments in the~     crucible of clinical practice. To help begin this process, the proposed research focuses on a~     specific treatment program for a specific cluster of disorders: Kendall's (1994)~     cognitive-behavioral Coping Cat program for child and adolescent anxiety disorders. The~     program has shown unusually positive effects across a series of clinical trials in the U.S.~     and Australia, but it has never been tested in real-world clinical conditions. The proposed~     study will test the effectiveness of the treatment with clinic-referred youth, treated in~     community clinics, with the treatment carried out by clinic staff therapists. Some 128 youth,~     aged 9-14, referred for anxiety and diagnosed with anxiety disorders, will be randomly~     assigned to receive either the usual treatment in the clinic, or the Kendall program, carried~     out by clinic staff who have been trained to proficiency. Therapists for the two treatment~     conditions will also be chosen randomly, from a pool of volunteers. Outcome assessment at~     immediate post-treatment, 1-year, and 2-year follow-ups, will test effects across many~     outcomes. It is hypothesized that outcomes for youths treated using the cognitive-behavioral~     treatment will be superior to those treated using usual care.~   "
195378|NCT01006031|"~     Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a~     (360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated~     liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard~     dose treatment of both drugs.~      (*) Non previous virological response: no decrease of plasma RNA-HCV at least 2 log10 after~     12 weeks in treatment or breakthrough viremia while on treatment.~      Additionally, this study will evaluated the influence of simultaneous peginterferon-alfa 2a~     and ribavirin plasma concentrations on early viral response (EVR) and sustained viral~     response (SVR) in these patients.~      Method: Pilot clinical trial, phase II-III, open labeled multicenter in which patients from~     several hospitals of the Servicio Andaluz de Salud will be enrolled.~      The usual clinical and analytical follow up will be performed but additional blood samples~     will be obtained for determination of interferon and ribavirin plasma levels. The primary end~     point will be a sustained virologic response (defined as an undetectable serum HCV-RNA after~     24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks~     of treatment), early virological response (at 12 weeks), and end of treatment response rates~     will be evaluated as well as their relationships with the plasma interferon an ribavirin~     concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the~     studied medications will be evaluated by means of clinical adverse events, physical~     examination and laboratory results. The evolution of liver fibrosis will be evaluated~     comparing the basal and end of treatment results of transient elastometry.~   "
195379|NCT01006018|"~     To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or~     without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and~     insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.~   "
195380|NCT01006005|"~     The study is recruiting 50 patients initiating or switching to Atripla and comparing them to~     250 individuals previously followed in a prospective study of HIV+ low income individuals~     recruited from homeless shelters, single room occupancy hotels and free meal food lines as~     part of the UCSF Reach Study. Adherence will be measured through monthly unannounced pill~     counts and electronic medication monitors.~   "
195381|NCT01005992|"~     The aim of our study is to determine the effect of fractional photothermolysis laser in the~     treatment of burn scars.~   "
195382|NCT01005979|"~     The purpose of this study is to determine the maximum tolerated dose (MTD), safety and~     toxicity when cyclophosphamide, rituximab and lenalidomide (Revlimid) are combined for the~     treatment of relapsed/refractory of chronic lymphocytic leukemia (CLL) and small lymphocytic~     lymphoma (SLL).~   "
195383|NCT01005966|"~     This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial~     caries lesions in an in situ model~   "
195384|NCT01005953|"~     As the prevalence of autism spectrum disorders continues to rise and the shortage of special~     education resources becomes more dramatic, the need for electronic tools that reduce the time~     burden of implementing an individual education plan (IEP) with pencil and paper methods~     becomes more apparent. SymTrend is going to expand its Internet and mobile~     computer/phone-based system for 1) collecting behavior data, 2) charting progress, 3)~     creating forms for #1 and #2, and 4) communicating within the IEP team, to include digital~     pen technology. Although this system will be tested with monitoring lower functioning~     children with autism, it has immediate relevance to a wide range of special education, mental~     health, and medical applications. The hypothesis is that this digital pen-based system will~     save time and money in the education of children on the spectrum and will enhance~     communication between schools and families.~   "
195385|NCT01005940|"~     This study is being done to see if treatment of obstructive sleep apnea (OSA) with a~     mandibular advancement device (MAD) shows an increase in the quality of life. Many patients~     prefer to call them mandibular advancers, jaw advancers, jaw advancement splints, jaw~     advancement devices, anti-snoring mouthpieces, or oral appliances for the treatment of~     snoring and mild to moderate obstructive sleep apnea. The investigators will also see how~     helpful the mandibular advancement device is on insulin resistance.~   "
195386|NCT01005927|"~     Fructooligosaccharides (FOS) are believed to have positive effects on calcium absorption and~     bone accrual during growth. This study aims to see whether the addition of fiber in the form~     of FOS to a calcium-containing beverage will increase calcium absorption. During two clinical~     visits, participants will receive a beverage containing a small amount of calcium,~     supplemented with either no dietary fiber or a small amount of fiber. Height, weight, bone~     density and geometry, calcium absorption, and physical fitness will be measured. The effects~     of this fiber intervention may provide support for improving bone health with minimal fiber~     supplementation.~   "
195387|NCT01005914|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects of giving pegaspargase together~     with combination chemotherapy and to see how well it works in treating patients with newly~     diagnosed acute lymphoblastic leukemia.~   "
195388|NCT01005901|"~     A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients~     with moderate-to-severe chronic obstructive pulmonary disease (COPD).~   "
195389|NCT01005888|"~     The study objective was to determine the safety and efficacy of C1INH-nf for the prevention~     of acute HAE attacks.~   "
195390|NCT01005875|"~     This study is to determine the safety and efficacy of stereotactic body radiotherapy (SBRT)~     and treatment drug in patients with hepatocellular carcinoma.~   "
195391|NCT01005862|"~     The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of~     ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and~     healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365,~     pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and~     tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease~     and healthy volunteers.~   "
195394|NCT01005823|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7~     days treatment with LEO 29102 in adult patients with atopic dermatitis.~   "
195488|NCT01004575|"~     The purpose of this study is to assess whether the new Kaname coronary stent is safe and~     effective for the treatment of patients with coronary artery disease.~   "
195399|NCT01005758|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects of combination chemotherapy and to~     see how well it works in treating adult patients with newly diagnosed acute lymphoblastic~     leukemia.~   "
195400|NCT01005745|"~     The overall purpose of this research study is to find a better way to treat melanoma. This~     will be a single arm exploratory trial to evaluate prospectively the feasibility of, the~     toxicities of, and the persistence of TIL which can survive in vivo.~   "
195401|NCT01005732|"~     Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the~     prevention of hypertrophic scarring in healed burns.~      Background - Approximately one million people are burned each year in the United States. The~     most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that~     interferes with work and all other aspects of life. Pressure garment therapy is routinely~     used to minimize hypertrophic scarring even though there is no scientifically valid data that~     this therapy is efficacious. Pressure garments are extremely unattractive, expensive and~     uncomfortable and their use needs to be based upon valid data.~      Goals and Objectives - The investigators plan to determine the effectiveness of pressure~     garment therapy in the control of hypertrophic scarring in healed burns.~      Methods - The I-Scan® device was designed to measure pressure at the body/environment~     interface and allows clinicians to deal with pressure-related problems for at-risk patients.~     It has been widely used in rehabilitation medicine but not with burn survivors. The~     investigators will use this device to measure the pressure at the garment/skin interface. 2)~     Furthermore, the few studies that have been attempted to determine efficacy have used between~     subjects designs. Since burn depth is extremely variable from patient to patient and since~     hypertrophic scarring is greatly influenced by age and race/origin, the between subjects~     design requires very large numbers of subjects. The investigators will use a within wounds~     design studying forearm burns and applying pressure to half of the wound and no pressure to~     the other half. The investigators will then compare hardness, color, thickness and clinical~     appearance.~   "
195402|NCT01005719|"~     This study will determine differences between Proton Pump Inhibitors (PPI) formulations~     relative to their effects on gastric acidity.~   "
195403|NCT01005706|"~     This study's focus is to compare the level effectiveness and safety of regimens involving~     Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American~     recipients of kidney transplants.~   "
195404|NCT01005693|"~     RATIONALE: Questionnaires that measure how well older patients think, learn, remember, and~     make judgments and carry out daily activities may improve the ability to plan treatment for~     patients with cancer.~      PURPOSE: This clinical trial is studying testing for fitness to undergo chemotherapy to see~     how well it works in predicting treatment outcomes in older patients with cancer.~   "
195405|NCT01005680|"~     The purpose of this study is to compare the efficacy and safety of two different chemotherapy~     types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).~   "
195406|NCT01005667|"~     The purpose of this study is to test the hypothesis that using the BirthTrack for management~     of labor shortens the time to delivery and thus improves both maternal and perinatal~     outcomes.~   "
195407|NCT01005654|"~     Background:~        -  Endocrine neoplasms (tumors) are among the fastest growing tumors in incidence in the~          United States. Furthermore, it is often difficult to distinguish between benign or~          malignant tumors in cancers of the thyroid, parathyroid, adrenal gland, and pancreas.~          More research is needed to improve detection and treatment options for patients who~          develop these kinds of cancer.~        -  Researchers are interested in studying the molecular changes that are involved in~          endocrine cancer development and growth. To collect a sample of tumor specimens and~          healthy tissue for further study, researchers are specifically looking for samples from~          patients who are scheduled for surgery or biopsy on endocrine tumors.~      Objectives:~      - To collect samples of precancerous, cancerous, and healthy tissue from individuals who are~     scheduled for surgery or biopsy of endocrine system tumors.~      Eligibility:~      - Individuals who have a tumor in or around their thyroid, parathyroid, adrenal gland,~     pancreas, or any neuroendocrine tissue, and are scheduled for surgery at the National~     Institutes of Health Clinical Center.~      Design:~        -  Participants in this study will provide blood and urine samples prior to surgery.~        -  During the surgery or biopsy, pieces of the tumor or precancerous growth and pieces of~          normal tissue near to the tumor will be removed for ongoing and future research. The~          rest of the tumor or growth will be sent for analysis.~        -  After surgery, participants will receive routine care until discharge, and doctors will~          discuss possible treatment options. If there is an appropriate NIH protocol,~          participants may choose to be treated at the NIH.~        -  After discharge, participants will return to the clinic for a routine postoperative~          check about 6 weeks following the operation, and then may be followed yearly at the~          Clinical Center or by phone.~   "
195408|NCT01005641|"~     Aromatase inhibitors are the standard treatment for hormone responsive advanced breast~     cancer. The combination of the aromatase inhibitor exemestane with with another breast cancer~     drug that blocks epidermal growth factor receptor (EGFR) and Erb-2 activity (lapatinib) is~     being studied for the possibility of improving response to therapy, and delaying resistance~     to endocrine therapy.~   "
195409|NCT01005628|"~     After the KFDA (Korea Food and Drug Administration) approval of a new drug, an annual report~     of the drug's safety and efficacy data must be reported to the Health Authority in 6 years.~     In this Observational study, we will investigate the basic demographic, medical history,~     concomitant drug use, as well as dosing information of multiple myeloma patients using~     bortezomib (Velcade).~   "
195410|NCT01005615|"~     To determine whether functional electrical stimulation (FES) promotes neurological and~     physical recovery in patients with spinal cord injury (SCI).~      The researchers will investigate the extent of functional recovery in patients with spinal~     cord injury who receive functional electrical stimulation in the upper extremities compared~     with patients who do not receive FES.~   "
195411|NCT01005602|"~     Dosing methods for digoxin, a drug used to treat heart failure, have not been updated in~     decades despite evidence in recent years suggesting that blood levels of digoxin achieved~     with traditional dosing practices may increase the risk of adverse events. We developed a~     simple dosing tool that targets lower blood levels of digoxin that have been associated with~     improved outcomes compared to higher blood levels. The aim of this study is to determine if~     this simplified dosing tool is more effective than standard digoxin dosing practices at~     achieving lower blood levels and also to determine if digoxin dosing may be further optimized~     by incorporating patients' genetic information believed to influence the drug's properties.~   "
195489|NCT01004562|"~     RATIONALE: Collecting and storing information from patients with cancer to study in the~     future may help doctors learn more about cancer.~      PURPOSE: This study is collecting information from patients enrolled in the Breast~     Specialized Program of Research Excellence.~   "
195412|NCT01005589|"~     Bacterial infections are a major cause of death in newborn infants. And are linked to~     complications including: sepsis (an over exaggerated immune response to infection) and~     necrotising enterocolitis (a potentially fatal inflammatory bowel disease).~      Detecting infections at an early stage is difficult in newborns as the signs and symptoms can~     be non-specific, the most commonly used lab test is to culture a sample of blood, urine or~     spinal fluid to try and grow and identify any bacteria that is present; however these tests~     take 24-48 hours to give results, and this means that neonates who present with signs of~     infection are prescribed broad spectrum antibiotics whilst results are obtained.~      The lack of a test that can detect infection at an early stage and give rapid results is one~     of the major problems in the diagnosis and management of infection in newborns. This study~     will investigate neutrophils, which are white blood cells that are important in fighting~     infection. When neutrophils detect and infection they become activated, and produce a protein~     called CD64 (a cell marker) on their surface, and it is this protein that we want to measure.~     Neutrophils produce the CD64 protein within 1 hour of first detecting an infection, so we~     could hopefully detect and treat infections much quicker.~      The hypothesis this study will test are:~        1. Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker~          of infection in neonates AND:~        2. Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker~          of NEC in neonates~   "
195413|NCT01005576|"~     This study is being done to determine if blood cell transplants, with either bone marrow or~     cord blood from unrelated donors, are effective in children with severe thalassemia and if~     this treatment approach has acceptable risks and side effects.~      This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine,~     Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation.~     The primary hypothesis is that this regimen will promote stable engraftment of unrelated~     donor hematopoietic cells, support normal erythropoiesis, and result in an event free~     survival of > 75% of children with thalassemia major.~   "
195414|NCT01005563|"~     The primary aims of this study are to assess the effects of habitual dietary protein intakes~     across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as~     the predominate sources of protein on indices of daily appetite and mood, and on postprandial~     appetite, mood, energy expenditure, and glycemic responses during energy-restricted weight~     loss in overweight adults.~   "
195415|NCT01005550|"~     This is a prospective, monocentric, randomized study, comparing the effectiveness and~     tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal~     anaesthesia during traumatic femoral neck surgery in the elderly.~   "
195416|NCT01005537|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Biological therapy, such as cellular adoptive immunotherapy using autologous~     lymphocytes, may stimulate the immune system in different ways and stop tumor cells from~     growing. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Giving~     cyclophosphamide together with autologous lymphocytes and aldesleukin may be an effective~     treatment for metastatic melanoma.~      PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide~     together with autologous lymphocytes and aldesleukin and to see how well it works in treating~     patients with metastatic melanoma.~   "
195417|NCT01005524|"~     The main objective of this study is to evaluate the usability of a system to assist verbal~     communication based on BCI system using the P300 wave in patients with tetraplegia who can no~     longer communicate because of severe engine damage (tetraplegia) and respiratory damage~     requiring invasive mechanical ventilation (intubation or tracheostomy) preventing verbal~     communication.~   "
195418|NCT01005511|"~     To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms~     and at the jaw muscle activity during sleep.~   "
195419|NCT01005498|"~     The purpose of the clinical trial is to investigate whether low carbohydrate diet is better~     than the traditional diabetic diet in the treatment of patients with diabetes mellitus type~     2, for blood sugar and body weight.~   "
195420|NCT01005485|"~     The primary hypothesis of this study is that circulating endothelial cells (CECs) harbor key~     genetic and structural characteristics predisposing individuals to acute atherosclerotic~     plaque rupture and heart attack.~   "
195421|NCT01005472|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with~     sunitinib malate may kill more tumor cells.~      Phase II was never conducted due to toxicity in phase I.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate~     when given together with temozolomide and to see how well they work in treating patients with~     stage III or stage IV malignant melanoma.~   "
195422|NCT01005459|"~     The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for~     CSE labor analgesia volume will last a significantly longer period of time that that of~     spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects~     meeting criteria when analgesia is requested will be randomized to receive a combined~     spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or~     bupivacaine 2 mg with fentanyl and epinephrine.~   "
195423|NCT01005446|"~     The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder~     Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a~     total shoulder replacement (primary and revision subjects).~   "
195424|NCT01005433|"~     Regional anesthesia has become the anesthetic of choice for cesarean section in most~     countries; however, some women still prefer general anesthesia techniques. There are many~     trials for the pharmacological modifications of the sympathetic response to surgery,~     including opioids, tenoxicam, ketorolac, lidocaine and paracetamol. However, opioid~     administration to the mother before delivery has adverse neonatal effects. This research is a~     novel trial on the use of dexmedetomidine for suppression of the hemodynamic and hormonal~     responses of cesarean delivery.~   "
195490|NCT01004549|"~     This study will determine the ability of three different intraocular lenses to accommodate in~     patients who have previously undergone bilateral intraocular lens implantation.~   "
195427|NCT01005394|"~     The past 10 years of research in persons more than 6 months post stroke have shown certain~     types of rehabilitation can help re-wire the brain. Transcranial magnetic stimulation (TMS)~     can be used to monitor this re-wiring by mapping the brain's function (measuring brain~     activity). Recent research suggests that TMS can be used for both prognosis (determining~     future function) and to determine what type of rehabilitation therapy will work best after~     stroke. The purposes of this research study are to: 1) determine changes in brain activity~     during the first 6 months after stroke (to determine how the brain re-wires); 2) compare~     changes in recovery of motor function with changes in brain re-wiring; 3) determine the~     ability of TMS to predict functional outcome in the first 6 months after stroke.~      The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as~     measure motor threshold (MT), motor evoked potentials (MEPs) and recruitment curves; 2)~     baseline TMS will predict future functional outcomes at 3 and 6 months.~   "
195428|NCT01005381|"~     This study has two research arms:~      The purpose of the 1st is to determine if a smaller particle size calcium carbonate~     supplement (than that which is now commercially available) improves calcium absorption and~     retention in adolescents girls.~      The purpose of the 2nd is to determine if vitamin D supplementation improves calcium~     absorption and retention in adolescents girls.~   "
195429|NCT01005368|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from~     patients with previously untreated chronic lymphocytic leukemia.~   "
195430|NCT01005355|"~     This trial is testing the investigational drug IMC-1121B administered to Japanese~     participants with advanced solid tumors who have not responded to standard therapy or for~     whom no standard therapy is available. The rationale for performing this trial is to~     establish the safety profile and the pharmacokinetics of IMC-1121B.~   "
195431|NCT01005342|"~     The aim of this study is to~        -  Measure the effect on gene expression in leukocytes from a meal rich in oat bran~        -  Investigate the postprandial glucose, insulin and triglyceride responses after intake of~          meals containing fiber from different sources (oat, rye and sugar beet fiber) or a meal~          containing a mixture of these three fibers~   "
195432|NCT01005329|"~     This phase II trial studies the side effects of giving intensity-modulated radiation therapy~     together with cisplatin and bevacizumab followed by carboplatin and cisplatin and to see how~     well they work in treating patients who have undergone surgery for high-risk endometrial~     cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the~     tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in~     chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and~     spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the~     tumor. Giving intensity-modulated radiation therapy together with chemotherapy and~     bevacizumab after surgery may kill any tumor cells that remain after surgery.~   "
195433|NCT01005316|"~     The purpose of this study is to determine the clinical outcomes of sensitized pediatric heart~     transplant recipients with a positive donor-specific cytotoxicity crossmatch and to compare~     this group with outcomes in nonsensitized heart transplant recipients.~   "
195434|NCT01005303|"~     There is some evidence to suggest that patients with heart failure may have a reduced dietary~     intake of vitamins and essential minerals (micronutrients) and that this may worsen the~     function of the heart. This study is designed to investigate if supplementation with~     micronutrients (including high−dose vitamin D) will improve the function of the heart in~     patients with heart failure.~   "
195435|NCT01005290|"~     The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given~     together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and~     ramipril) to the effect on systolic pressure of ramipril given alone.~   "
195436|NCT01005277|"~     RATIONALE: Studying samples of DNA from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is looking at biomarkers in DNA samples from patients with acute~     lymphoblastic leukemia or acute myeloid leukemia.~   "
195437|NCT01005264|"~     1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable~          fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer~        2. Research design and methods: Forty-five adult diabetic patients with non-ischemic,~          non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable~          fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment~          duration was 90 days. Percent reduction in ulcer surface area and total healing rates~          were evaluated after treatment.~   "
195438|NCT01005251|"~     This study is being carried out to see whether AZD3355 is an effective treatment as an add-on~     to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial~     response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another~     goal of the study is to examine which of the investigated doses of AZD3355 is optimal for~     treatment of these patients. This study will also measure levels of drug in the blood and see~     how well it is tolerated.~   "
195439|NCT01005238|"~     The aim of this randomized clinical study is to show non-inferiority of a change of~     anti-viral therapy from telbivudine to lamivudine in patients who have achieved an~     undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment~     with telbivudine with respect to the viral breakthrough rate at week 108 as the primary~     clinical outcome.~   "
195440|NCT01005225|"~     The objective of this study is to obtain blood samples, solid tumor and/or benign hyperplasia~     samples to learn more about genetic differences that are linked to the formation of solid~     tumors.~   "
195457|NCT01004991|"~     This is a phase I/II open label, multi-center study of azacytidine in combination with~     standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at~     escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on~     day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion~     will then evaluate efficacy of the combination at the established MTD.~   "
195441|NCT01005212|"~     This study will be a cross-sectional survey of interobserver variability associated with~     contrast enhanced ultrasound (CEUS) to detect endoleaks using computed tomographic~     angiography (CTA) as the practice standard. The investigators will enroll 40 consecutive~     patients undergoing endovascular abdominal aortic aneurysm repair (EVAR). At the first~     follow-up visit after the procedure, participants will undergo two abdominal ultrasound~     examinations with and without contrast, and one CTA. Analyses will be conducted to examine~     interobserver variability in the detection and characterization of endoleaks using~     contrast-enhanced ultrasound (CEUS). Other endpoints include examination of sensitivity and~     specificity of CEUS compared to CTA, and characterization of the number and types of~     endoleaks detected.~   "
195442|NCT01005199|"~     RATIONALE: Sorafenib tosylate and everolimus may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This randomized phase II trial is studying giving sorafenib tosylate together with~     everolimus to see how well it works compared with sorafenib tosylate alone in treating~     patients with localized, unresectable, or metastatic liver cancer.~   "
195443|NCT01005186|"~     A lifestyle intervention aimed at improving exercise levels in primary school children.~   "
195444|NCT01005173|"~     This study is a non-intervention, multicenter study to address biomarkers of acetaminophen~     toxicity in children. Specifically, the study will examine acetaminophen (APAP) protein~     adducts and markers of liver injury in the blood samples of hospitalized children and~     adolescents who are receiving standard doses of acetaminophen, and children and adolescents~     who are status post acetaminophen overdose. Ultimately, the data generated from this study~     will be used to establish second generation biomarkers of acetaminophen toxicity, based on~     specific adduct proteins, which can be used in future risk assessment studies of children~     receiving acetaminophen.~   "
195445|NCT01005160|"~     The purpose of this study is to evaluate safety, tolerance by comparing availability and the~     pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone~     and combination to healthy male volunteers.~   "
195446|NCT01005147|"~     The investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to~     conventional therapy will lead to an improved outcome characterized by lower transfusion~     requirements.~   "
195447|NCT01005121|"~     Patients with diabetic nephropathy and proteinuria, despite maximal anti- hypertensive and~     anti-glucose treatment, will receive colchicine for six months, 2 mg a day, during which~     their 24 hour urine protein and renal function tests will be monitored. The investigators'~     hypothesis is that colchicine will diminish proteinuria and might also help slow down the~     development of end stage renal failure in the long run.~   "
195448|NCT01005108|"~     Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and~     gabapentin to their respective placebo controls in the treatment of hot flashes in breast~     cancer patients. The investigators primary specific aim will focus on determining the~     magnitude of response to placebo acupuncture versus placebo pills on hot flashes (HFs).~   "
195449|NCT01005095|"~     The investigators hypothesize that vitamin D supplementation may ameliorate interferon~     beta-induced flu-like symptoms, owing to reduced release and activity of the cytokines that~     are in correlation with this adverse event. Vitamin D supplementation may also positively~     affect injection site reactions due to its immunomodulatory effects. Vitamin D may also~     augment the therapeutic efficacy of interferon beta among multiple sclerosis (MS) patients.~     Vitamin D intake may influence melatonin levels of MS patients as they share the same nuclear~     receptor.~   "
195450|NCT01005082|"~     Randomized clinical trial comparing water therapy plus low-salt diet to water therapy alone~     in patients affected by idiopathic calcium nephrolithiasis.~      Treatment duration: three months Primary end-point: correction of hypercalciuria Main~     inclusion criteria: calcium stone formers with idiopathic hypercalciuria, with at least one~     stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (>300~     mg/day in males and >200 mg/day in females); 18-65 years.~      Main exclusion criteria: primary hyperparathyroidism, primary hyperoxaluria, enteric~     hyperoxaluria, bowel resection, inflammatory bowel disease, renal tubular acidosis,~     sarcoidosis, sponge kidney, hyperthyroidism, use of hypercalciuric drugs such as Vitamin D,~     acetazolamide, anti-epileptic drugs~   "
195451|NCT01005069|"~     The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the~     management of subjects with type-II-diabetes mellitus and to determine the minimal effective~     dose of DLBS 32 for subjects with type-II-diabetes mellitus.~   "
195452|NCT01005056|"~     The purpose of this study is to evaluate the efficacy and safety of Marvelon® in the~     prevention of pregnancy.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
195453|NCT01005043|"~     The primary objectives of this trial are the determination of feasibility and toxicity of~     Heavy Ion Radiotherapy (C12) in patients with non-resectable osteosarcoma. Secondary~     endpoints are tumor response, disease free survival and overall survival. The aim is to~     improve outcome for patients with non-resectable osteosarcoma.~   "
195454|NCT01005030|"~     The primary objective of the study is to determine the utility of blood plasma infrared~     spectroscopy (biospectroscopy) in distinguishing subjects with idiopathic Parkinson's disease~     from healthy controls.~   "
195455|NCT01005017|"~     Chronic pancreatitis is a progressive inflammatory disease resulting in slow destruction of~     the pancreas. This chronic inflammation can lead to chronic abdominal pain which can last for~     many years. Unfortunately, medical management often is of only limited benefit in treating~     the pain of chronic pancreatitis.~      Management of patients with intractable pain is difficult, often resulting in narcotic~     addiction.~      Early results in a small group of patients suggest that percutaneous radiofrequent lesioning~     of splanchnic nerves has good potential for pain control in a subset of patients with chronic~     pancreatitis. Given the simplicity of the procedure, it clearly warrants reappraisal to~     identify its current role in pancreatic pain management.~   "
195456|NCT01005004|"~     The purpose of this study is to determine the safety and preliminary effectiveness of human~     central nervous system stem cells (HuCNS-SC®) transplantation in patients with Connatal~     Pelizaeus-Merzbacher Disease (PMD).~   "
195458|NCT01004978|"~     This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how~     well they work compared with chemoembolization alone in treating patients with liver cancer~     that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin~     hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels~     near the tumor and then blocking the blood flow to allow a higher concentration of the drug~     to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether giving chemoembolization together with sorafenib tosylate is more effective than~     chemoembolization alone in treating patients with liver cancer.~   "
195459|NCT01004965|"~     This research study is looking at bone marrow and blood samples in patients with untreated~     acute myeloid leukemia or acute lymphoblastic leukemia enrolled on clinical trial CALGB-9621,~     CALGB-9720, CALGB 19808, and CALGB 10201. Studying samples of bone marrow and blood from~     patients with cancer in the laboratory may help doctors learn more about changes that occur~     in DNA and identify biomarkers related to cancer. It may also help doctors predict how~     patients will respond to treatment.~   "
195460|NCT01004952|"~     The purpose of this study is to understand how people make decisions about sun protection.~     This study is important in helping to protect against sun exposure, since it is a main risk~     factor for melanoma. The investigators would like to understand the decisions people make~     about sun protection so that they can improve their ability to help individuals who may be at~     risk for melanoma.~   "
195461|NCT01004939|"~     The objective of this retrospective study is to gather information about how fondaparinux is~     used pre-, peri- and/or postpartum for both the prophylaxis and treatment of venous~     thromboembolism (VTE) in order to fill an information gap concerning the off-label use of~     fondaparinux during pregnancy.~   "
195462|NCT01004926|"~     The aim of this work was to test the Echelon foot efficiency to offer enhanced safety,~     comfort and function over a wide range of walking surfaces, inclines and stairs, thereby~     improving the quality of life for amputees.~      Ten individuals with a unilateral trans- tibial amputation will participate in two test~     sessions- one while using their own prosthetic foot, the other while using the Echelon foot.~   "
195463|NCT01004913|"~     Benign Paroxysmal Positional Vertigo (BPPV) is the most frequent cause of vertigo of~     peripheral vestibular origin with life time incidence of 2.4%. BPPV is characterized by bouts~     of acute whirling vertigo lasting less than one minute provoked by changes in head position~     in relation to the gravitational vector. The vertigo is accompanied by typical rotational or~     horizontal nystagmus that is often demonstrated by the Dix-Hallpike maneuver and less~     frequently by testing for positional nystagmus. BPPV pathogenesis is currently explained by~     the fall of otoconia (calcium-carbonate crystals) or otoconial debris from the tectorial~     membrane of the otolithic organs into the dependant semicircular canals (canalithiasis) or~     adherence of such particles to the semicircular canal's cupula (cupulithiasis). Under these~     circumstances, the semicircular canal which normally responds only to angular velocity and~     acceleration is stimulated by gravity. Otoconial remnants as free floating particles inside~     the semicircular canal arms or attached to the cupula have been observed by few~     investigators. Although the presence of such particles explains most characteristics of the~     positioning nystagmus described in BPPV, it does not account for the dizziness and~     disequilibrium which are described by many patients even without changes in head position and~     the continuation of such symptoms after successful treatment of BPPV as evidenced by the~     resolution of positional vertigo and nystagmus.~      The study hypothesis is that otolithic pathology is an important component in the~     pathogenesis of BPPV explaining these symptoms, BPPV recurrence, and the refractoriness of~     some BPPV cases to the vastly employed particles repositioning treatments. In the present~     study the Vestibular Evoked Myogenic Potentials (VEMP) testing would be employed to measure~     the function of one of the otolithic organs - the saccule. The study objectives are: 1. To~     investigate possible malfunction of the saccule in patients suffering from BPPV. 2. To look~     for association between saccular pathology and BPPV recurrence and between such pathology and~     BPPV treatment failure. 3. To study possible relation between saccular pathology and~     continuation of dizziness and disequilibrium despite the resolution of positional vertigo.~   "
195464|NCT01004900|"~     Glaucoma affects 66 million people worldwide and is the leading cause of irreversible~     blindness, and Primary angle-closure glaucoma (PACG) is a major form of glaucoma in Asia.~      Laser peripheral iridotomy (LPI) has been advocated as the first line treatment in all cases~     of PACG. In addition to relieving the relative pupil block element of the condition, it can~     open up the drainage angle, alleviating appositional and synechial angle-closure and in the~     long-term this may control intraocular pressure (IOP) and prevent progression of glaucomatous~     optic neuropathy. However recent data indicate that iridotomy is not successful in~     controlling IOP in the long term, and the majority of cases develop a clinically significant~     rise in IOP requiring medical therapy or surgery.~      Laser trabeculoplasty has been a recognized treatment option for Primary open angle glaucoma~     (POAG) since the 1980s. Recently a more selective and less destructive method of performing~     laser trabeculoplasty has evolved. Selective Laser Trabeculoplasty (SLT) specifically targets~     the pigmented trabecular meshwork cells without producing collateral damage and destruction~     to adjacent structures. Morphologic study performed on human autopsy eyes treated with SLT~     noted no structural or collateral thermal damage to the trabecular beams in the uveal and~     corneoscleral meshwork. As SLT specifically has its effect on the targeted pigmented~     trabecular meshwork it is unlikely to generate PAS. It may be a useful treatment option for~     PACG patients in whom the angle has widened following laser peripheral iridotomy.~      The proposed study is a randomized controlled trial to assess the effectiveness of SLT in~     reducing IOP in cases of PACG in which the angle has opened up following LPI, but IOP remains~     high(>21 mmHg). 100 subjects will be randomized to receive either SLT or medical treatment to~     achieve IOP control. They will be followed up for 6 months.~   "
195465|NCT01004887|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This research study is looking at tissue and blood samples from patients with~     high-grade glioma.~   "
195466|NCT01004874|"~     This is a phase II study of the combination of radiation therapy, temozolomide and Avastin~     followed by Avastin, temozolomide, and topotecan in grade IV malignant glioma patients.~   "
195467|NCT01004861|"~     PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary~     objective of this study is to evaluate the safety and pharmacokinetics of orally administered~     PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are~     linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic~     activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.~   "
195468|NCT01004848|"~     The purpose of this study is to compare the effectiveness of a peer-led community-based~     lifestyle intervention, versus usual care, in achieving weight loss and prevention of~     diabetes among overweight adults with pre-diabetes in East Harlem.~   "
195469|NCT01004835|"~     The objective of this study is to obtain blood or saliva samples to define genes for migraine~     and pain diseases.~   "
195470|NCT01004822|"~     The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when~     given as weekly infusions to adult patients with advanced solid tumors.~   "
195474|NCT01004770|"~     This is a non-randomized dose-escalating study that will evaluate the safety and tolerability~     of GE-145 at four different dose levels through the assessment of clinical laboratories,~     vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity~     of adverse events (AEs). It will characterize the pharmacokinetic properties of GE-145~     through the evaluation of serum and urine. It will evaluate the radiographic density in~     regions of interest (ROI) and the overall diagnostic quality following administration of~     GE-145.~   "
195475|NCT01004757|"~     Compared to the traditional low fat diet for overweight patients with type 2 diabetes, recent~     evidence shows that low carbohydrate/high protein diets lower triglycerides and postprandial~     glucose levels more effectively. However, it is not known, whether this diet can also improve~     the subclinically impaired myocardial function in type 2 diabetes. This prospective parallel~     group and cross over design study compares the effects of a low glycemic and insulinemic diet~     (LOGI®) with an isocaloric traditional low fat diet during a three weeks rehabilitation~     programme with aerobic exercise for overweight type 2 diabetes patients testing the~     hypothesis, that the low carbohydrate diet improves myocardial function and insulin~     resistance.~   "
195476|NCT01004744|"~     The purpose of this study is to determine the feasibility of a short term administration of a~     targeted therapy (i.e., anastrozole) in women with newly diagnosed early invasive or non~     invasive breast cancer during the interval between their breast biopsy and surgery.~     Anastrozole is a form of hormonal therapy which is part of the standard treatment for hormone~     sensitive breast cancer in postmenopausal women. This clinical model is being used to~     evaluate the biologic effects of this drug on a specific molecular pathway called the~     PI3K/AKT signaling pathway.~   "
195477|NCT01004731|"~     The objective is to evaluate the toxicity profile, response rate, and time to progression of~     Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with~     advanced non-small cell lung cancer with positive EGFr expression.~   "
195478|NCT01004718|"~     RATIONALE: Imaging procedures, such as positron emission tomography or computed tomography,~     may help in detecting differences between Hodgkin lymphoma or diffuse large B-cell lymphoma~     cancer cells. PURPOSE: This clinical trial is studying positron emission tomogaphy and~     computed tomography in determining differences in Hodgkin lymphoma and diffuse large B-cell~     lymphoma.~   "
195479|NCT01004705|"~     This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the~     cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril)~     as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76~     subjects will be screened, 60 randomized in order about 52 subjects to finish the study.~   "
195480|NCT01004692|"~     Rationale: The effect of vertical dimension on sleep apnoea and respiratory variables in~     obstructive sleep apnoea patients.~      Objective: To what extend should a possible worsening of the OSA condition, caused by an~     increase of mouth opening be taken into consideration in daily dental practice, when an~     occlusal stabilization splint (OSS) is placed in the mouth.~      Study design: Cross over RCT-design Study population: OSA patients referred to ACTA from the~     Slotervaart Hospital, for treatment with a Mandibular Advancement Device (MAD), at least 18~     years old.~      Intervention: Occlusal stabilization splint (OSS) for the upper jaw and a controlled~     condition in a cross-over design Main study parameters/endpoints: Apnoea- Hypopnoea Index~     (AHI) and the Epworth Sleepiness Scale (ESS).~      The aim of this study is to determine the effect of vertical dimension of OS on sleep and~     respiratory variables in OSA patients. The hypothesis is that insertion of an OSS and an~     increase of the vertical dimension will result in a significant increase in the AHI.~   "
195481|NCT01004666|"~     Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose~     of the current study is to assess the clinical performance of the new scintigraphic~     technology, a dedicated breast gamma camera composed by the new generation of CZT~     detectors,for assessment of breast pathology specifically in women where current imaging~     techniques, mainly mammography are suboptimal. These cohort are patients with dense breast~     tissue and patients who are at high risk for breast cancer by a combination of other metrics,~     including family history and genetic testing. BRCA (breast cancer susceptibility gene), is~     particularly a relevant health problem among Ashkenazi Jews in Israel.~   "
195482|NCT01004653|"~     A single center, Open-Label phase IV clinical trial is to be conducted in healthy elders~     (equal to or more than 61 years to evaluate the immunogenicity and safety of Sinovac's 15μg~     H1N1 influenza A Vaccine (Split virion), Inactivated.~   "
195483|NCT01004640|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer may help~     doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at blood and bone marrow samples in patients with~     chronic myelogenous leukemia enrolled on a CALGB clinical trial.~   "
195484|NCT01004627|"~     Dialysis patients have their blood filtered by a machine as their kidneys no longer work. To~     get blood in and out of these patients it is possible to perform a surgical procedure to~     increase to size and durability of a vein in the arm to allow repeated needle insertion. This~     enlarged vein is called a fistula. There is some evidence that ultrasound scanning the blood~     vessels in the arm before surgery can improve the chances of a successful procedure. The~     investigators aim to test whether scanning all patients is better than scanning only those~     who are difficult to assess by physical examination alone.~   "
195485|NCT01004614|"~     This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD)~     tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are~     bioequivalent.~   "
195486|NCT01004601|"~     Docetaxel and pemetrexed have been validated for previously treated advanced non-small cell~     lung cancer (NSCLC); however, tolerability is a concern with the docetaxel (tri-weekly 75~     mg/m2 schedule). The investigators conducted this study to compare the efficacy and toxicity~     of weekly low-dose docetaxel versus tri-weekly pemetrexed for previously treated advanced~     NSCLC.~   "
195487|NCT01004588|"~     The main objective of this study is to examine the effects of resistance type exercise~     training combined with nutritional support on body composition and muscle characteristics in~     healthy elderly men and women. For a comprehensive insight into the potential underlying~     mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad~     range of tests will be performed before, during, and after the intervention period.~   "
195491|NCT01004536|"~     Silicone gel is a self-drying silicone polymer that forms thin film after application onto~     the skin. Because silicone film is a medical device, silicone gel is also regarded as a~     medical device. Silicone gel has been on the market for many years for the management of scar~     in the phase of treatment as well as in the phase of prevention. In contrast to other methods~     that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and~     also reasonably priced. However, the number of well-designed clinicial trials for efficacy~     and safety are not enough to provide robust evidences in making clinical decisions for scar~     management options. In a prospective, multi-center, investigator-blind randomized half-split~     study for patients undergoing cesarean sections, the investigators attempt to provide valid~     information for the efficacy and safety of silicone gel in the prevention phase of scar.~   "
195492|NCT01004523|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This research study is looking at tissue and blood samples from patients with~     low-grade glioma.~   "
195493|NCT01004510|"~     The purpose of this study is to evaluate whether the addition of the bisphosphonate Zometa~     (zoledronic acid) used along with standard regimens of chemotherapy, will help to control the~     need for palliative intervention of malignant pleural effusions due to non-small cell lung~     cancer.~   "
195494|NCT01004497|"~     The main aim of the present study is to evaluate the clinical efficacy of first-line~     dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive acute lymphoblastic~     leukemia. In this study, the investigators will analyze the clinical outcomes for entire~     patient population as well as those for transplants, respectively. In addition, the results~     of this study will be compared to those of the investigators current study (imatinib plus~     conventional chemotherapy). The safety of this treatment will also be studied.~   "
195495|NCT01004484|"~     Hypothesis:~        -  Daily consumption of yogurt containing probiotic bacteria (Bb12) and inulin will~          significantly decrease whole gut and intestinal segmental transit time~        -  The effect of accelerating intestinal transit will be associated with other GI~          physiology parameters including stool frequency and stool consistency.~   "
195496|NCT01004471|"~     The purpose of this exploratory study is to determine the effect of a prototype nasal dilator~     strip on nasal resistance during sleep in subjects who complain of chronic, nocturnal~     congestion and have trouble with their sleep.~   "
195497|NCT01004458|"~     Previous studies have shown that the disorder fibromyalgia often is preceded by long-term~     stress. Moreover, an association has been shown between stress, pain and co-morbidity in~     these patients. Cognitive behavioral therapy (CBT) has been shown effective in reducing~     stress, anxiety and pain in rheumatoid arthritis and fibromyalgia. The purpose of the present~     trial was to assess whether CBT may reduce pain and other symptoms and increase well-being~     and general function, affect biological markers for pain and long-term stress, to a larger~     extent than treatment as usual.~      Forty eight women with verified fibromyalgia were randomly allocated to an early treatment~     group or a waiting list group. The early treatment group received CBT group treatment during~     six months. Measurements of outcome and potential outcome affecting variables were made at~     baseline, after six months and one year after baseline. The waiting list group received the~     same CBT treatment as the early treatment group after six months on the waiting list.~      The design is thus a traditional waiting list design, allowing a two parallel group~     comparison during the first six months and a before-after analysis in both groups when the~     treatment was concluded.~   "
195498|NCT01004445|"~     This study is part of a research program too see if amikacin delivered as an aerosol directly~     to the lungs in combination with IV antibiotic therapy can help intubated patients with~     gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The~     primary purpose of this study is to determine the correct dose of amikacin which is delivered~     directly to the lungs as an aerosol via an investigational device called the Pulmonary~     Delivery Device System (PDDS).~   "
195499|NCT01004432|"~     The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid~     arthritis (RA) participants who have an inadequate response to their current treatment with~     either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50~     milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of~     upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also~     designed to evaluate the benefit and safety of switching participants from treatment with~     golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram~     per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a~     marked improvement of their RA at Week 16.~   "
195500|NCT01004419|"~     The purpose of this study is to evaluate the safety and tolerability of vandetanib and~     fulvestrant; to find the maximum tolerated dose of these two drugs; and to evaluate response~     rate and assess toxicity of this combination.~   "
195501|NCT01004406|"~     The purpose of this randomized, multi-site, clinical trial is to determine whether intensive~     therapy consisting of cholesterol-lowering statin drugs plus apheresis to cleanse the blood~     of low-density lipoprotein (LDL) cholesterol is more effective than statin therapy alone in~     reducing plaque volume in heart arteries of patients who have already suffered an acute~     coronary syndrome (ACS). The study will also investigate whether this intensive approach can~     help increase the presence of endothelial progenitor cells (EPC), stem cells that have been~     shown to reduce CV events in ACS patients. This study has II phases and FDA approval for~     phase II has been received.~   "
195502|NCT01004393|"~     The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving~     opioid-induced constipation in cancer patients at various stages of disease.~   "
195503|NCT01004380|"~     The purpose of this study is to evaluate whether combination therapy with farletuzumab~     (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.~   "
195514|NCT01004237|"~     The investigators hypothesize that pravastatin combined with valsartan may have additive~     effects in hypertensive, hypercholesterolemic patients.~   "
195515|NCT01004224|"~     The study will determine the maximum tolerated dose and thus the recommended phase II dose~     and schedule of the compound and characterize the safety.~   "
195504|NCT01004367|"~     Worldwide, low-income and middle-income countries are undergoing rapid demographic and~     nutritional changes. Populations tend to move from their traditional food habits towards~     dietary patterns characterized by a more energy-dense diet, while urbanization and technology~     (work, transport) play a role in the reduction of their physical activity. This shift towards~     energy-dense diets and lower levels of physical activity are key determinants of chronic~     diseases. Nowadays, childhood overweight and obesity are becoming a major threat to public~     health all in low-income and middle-income countries. Clearly, not properly addressing this~     health problem will only aggravate the already enormous impact of chronic diseases on the~     social and economic development of these countries. This study aims to develop a culturally~     relevant school-based prevention intervention among Ecuadorian adolescents (11-13 years old)~     in Cuenca. The intervention will target behavioural nutrition and physical activity.~     Intervention strategies will be developed based on theoretical behavioural change models~     integrated in two complementary frameworks, i.e. (i) the Intervention Mapping protocol, and~     (ii) the Comprehensive Participatory Planning and Evaluation protocol.~      The study includes two phases:~        1. A formative research, which will be conducted in order to understand the causality of~          the school environment and unhealthy eating and low physical activity levels in~          school-going adolescents, aged 12-13 years old.~        2. A paired, cluster-randomized controlled trial including 1400 adolescents (12-13 years~          old) from 10 pairs of schools (i.e. clusters). Within each pair of clusters, one cluster~          will be randomly assigned to the intervention and the other to the control group.~   "
195505|NCT01004354|"~     Children and adolescents with psychiatric illnesses who are treated with medications called~     second generation antipsychotic agents (SGA) often gain excessive weight during their~     treatment with these medications. This weight gain may result in the development of features~     of the metabolic syndrome or frank diabetes mellitus. There is no consensus on the best way~     to prevent these complications. The investigators' hypothesis is that daily vitamin D~     supplementation in these patients will result in decreased levels of the markers of metabolic~     syndrome with associated reduction in waist circumference.~   "
195506|NCT01004341|"~     The purpose of this study is to evaluate the role of different parenting skills and parenting~     styles in the success of children enrolled in a family-based behavioral weight control~     program and to compare these skills and styles to those used by families with normal weight~     children.~   "
195507|NCT01004328|"~     The incidence of drug-induced injury is high in the ambulatory geriatric population,~     especially for elders with complex healthcare needs during high risk transitions to the~     ambulatory setting. In a previous study funded by the National Institute on Aging and the~     Agency for Healthcare Research and Quality [AHRQ] (AG 15979), the investigators determined~     that drug-related injuries occur at a rate of more than 50 per 1000-patient years in older~     adults in the ambulatory setting and that 28% are preventable. Independent risk factors for~     adverse drug events among older adults in the ambulatory setting included advanced age,~     multiple comorbid conditions, and the use of medications requiring close monitoring. In this~     project, Using HIT to Improve Transitions of Complex Elderly Patients from SNF to Home (1 R18~     HS017817), the investigators are testing the use of an electronic medical record (EMR)-based~     transitional care intervention for complex elderly patients transitioning from subacute care~     in a skilled nursing facility (SNF) to the ambulatory setting. The growing trend for~     physicians and other healthcare providers to restrict their practices to single settings and~     not follow complex patients as they move between settings leaves older patients discharged~     from subacute care particularly vulnerable. This transition is uniquely challenging because~     of the complex healthcare needs of this population, who often require outpatient primary care~     physicians to coordinate with visiting nurses in order to manage complex medication regimens~     and fluctuating clinical status. To facilitate high-quality transitions from the subacute to~     the ambulatory setting and support interdisciplinary communication, the investigators will~     use the EMR to assure that physicians in the ambulatory setting receive key health~     information and alerts.~   "
195508|NCT01004315|"~     To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.~   "
195509|NCT01004302|"~     Up to 40% of Obsessive-Compulsive Disorder (OCD) patients do not respond to conventional~     treatments (medications or behavior therapy). For some of them, a neurosurgical treatment can~     be indicated. Among various surgical techniques, Gamma Knife radiosurgery has the advantage~     of not requiring the production of burr hole openings in the skull. However, there are no~     randomized controlled trials of radiosurgical procedures.~      The investigators' aim is to investigate whether radiosurgery for the treatment of severe and~     refractory OCD is efficacious and safe, by a double-blind, randomized controlled trial.~     Forty-eight refractory OCD patients will be randomized into two different groups: the first~     one will receive standard radiosurgery; the second group will be submitted to a false~     radiosurgery (sham operation). Patients who had been previously submitted to sham surgery~     will be able to undergo real operations after one year of follow-up, when blinding is broken.~     For a minimum period of one year, patients will be periodically followed-up in terms of~     psychiatric changes (including OCD symptoms), global functioning, cognitive/personality~     changes and neuroimaging findings.~   "
195510|NCT01004289|"~     The POST-conditioning during coronary angioplasty in Acute Myocardial Infarction (POST-AMI)~     trial will evaluate the usefulness of postconditioning in limiting infarct size and~     microvascular damage during the early and late phases after AMI.~   "
195511|NCT01004276|"~     This pilot study will determine the feasibility of studying a new smoking cessation~     management module in an existing chronic disease management system. The new module is~     intended to help healthcare providers deliver more smoking cessation counselling to their~     patients.~   "
195512|NCT01004263|"~     To provide long term safety data for rizatriptan in children and adolescents. The primary~     hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of~     acute migraine in pediatric patients age 12-17 years.~   "
195513|NCT01004250|"~     Participants with advanced non-small cell lung cancer (NSCLC) will receive a first-line~     treatment of Pemetrexed, Cisplatin and Bevacizumab as induction therapy followed by a~     maintenance treatment of Pemetrexed and Bevacizumab. Treatment will continue until disease~     progression or unacceptable toxicity occurs. The primary objective of this study is to~     measure how long this treatment could prevent the disease progression.~   "
195516|NCT01004211|"~     To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective~     within patient trials but only as an add on procedure. This results in a bias that does not~     allow to determine the real impact of such innovative technologies on bladder cancer~     management. Hereby we propose the first prospective randomized trial which compares narrow~     band imaging trans urethral resection as a stand alone procedure versus white light~     transurethral resection. The primary end point is to assess the recurrence rate of bladder~     cancer lesions with each treatment modality. The study is designed to disclose an inferior~     recurrence rate (estimated 10%) in the group treated by narrow band imaging transurethral~     resection respect to the control group, treated by standard transurethral resection.~   "
195517|NCT01004198|"~     MP4OX is a novel oxygen therapeutic agent specifically developed to perfuse and oxygenate~     tissue at risk for ischemia and hypoxia. MP4OX is a pegylated hemoglobin-based colloid and~     and as a result of its molecular size and unique oxygen dissociation characteristics, targets~     oxygen delivery to ischemic tissues by selectively off-loading oxygen in tissues predisposed~     to low oxygen tension. Sangart is currently evaluating MP4OX to reduce organ dysfunction and~     failure in trauma patients with lactic acidosis due to severe hemorrhagic shock.~   "
195518|NCT01004185|"~     The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and~     high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg~     delayed-release tablets given twice daily for 26 weeks to children and adolescents for the~     maintenance of remission of ulcerative colitis.~   "
195519|NCT01004172|"~     The purpose of this research study is to determine how well the combination of bevacizumab~     and carboplatin works in treating breast cancer that has spread to the brain. Bevacizumab is~     an antibody (a protein that attacks a foreign substance in the body) that is made in the~     laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Usually~     chemotherapy drugs attack fast growing cancer cells in the body. Bevacizumab works to slow or~     stop the growth of cells in cancer tumors by decreasing the blood supply to the tumors. When~     the blood supply is decreased, the tumors don't get the oxygen and nutrients they need to~     grow. Carboplatin is in a class of drugs known as platinum-containing compounds and has been~     approved for use in the treatment of ovarian cancer. Information from other research studies~     suggests that the combination of bevacizumab with carboplatin may be effective in treating~     breast cancer.~   "
195520|NCT01004159|"~     This study is being performed to test if the use of high dose of cetuximab in combination~     with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan~     in patients with wild type KRS tumors that have advanced colon or rectal cancer~   "
195521|NCT01004146|"~     The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as~     an aid to improve postoperative lung function. The hypothesis is that application of a~     standardized protocol of preoperative respiratory care teaching and exercise will improve~     lung performance that will subsequently result in prevention of postoperative pulmonary~     complications and that increasing the duration of preoperative use better improves lung~     mechanics postoperatively. The investigators propose to compare a patient population that~     uses IS as currently prescribed in the routine course of care (only to be familiar with~     preoperatively, but use postoperatively) against a population that uses IS with a~     standardized regimen for at least 3 days prior to the operation in terms of preoperative IS~     volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of~     postoperative pulmonary complications.~   "
195522|NCT01004133|"~     With the completion of the human genome project, investigators can now explore new questions~     in human biology. Previously human genetics focused on highly penetrant, Mendelian traits;~     however, now rare and common variants can be discovered that affect common diseases that~     have multi-gene architecture with variable penetrance such as breast cancer, diabetes~     mellitus, and coronary artery disease. This change took place because investigators now have~     the tools to illuminate the whole genome at once to discover the genetic variants responsible~     for different disease phenotypes through statistical differences between populations. Besides~     disease phenotypes, health can be considered a human phenotype that can be studied. Health is~     not merely the absence of disease but may be viewed as a dynamic ongoing interplay between~     the environment and the genome to maintain homeostasis. Individuals often attempt to optimize~     environmental conditions according to ones genome to maximize their health. All individuals~     possess potentially beneficial and harmful variants depending on the environment. How this~     dynamic interplay occurs between the genome and environment requires understanding the~     boundary conditions of the genetic architecture of health and disease and then modeling the~     system to simulate the observed data.~      The aging process also affects health. Aging involves a loss of the normal coping responses~     to internal and external environmental stressors or signals. Investigators now have the tools~     to uncover from the bottom up the mechanisms involved in maintaining the ability to overcome~     environmental conditions that can affect health.~      Against this genomic breakthrough of whole genome association studies, the demographics in~     the United States are quickly changing. The older population (age > 65 years) in 2030 is~     projected to be twice as large as in 2000 representing nearly 20 percent of the total US~     population. The first baby boomers turn 65 in 2011 and will challenge all facets of health~     care in the coming decades. The demographic changes underscore the need to understand the~     mechanisms that promote health and disease in this cohort. Genomic discoveries will help~     individuals and may reduce medical costs and benefit society.~      In summary, the objective of this study is to obtain blood and/or saliva samples in order to~     help model health and disease phenotypes through population genomics. The blood and/or saliva~     samples may allow for participants' entire genomes to be sequenced if such comprehensive~     analysis becomes feasible and economical.~   "
195523|NCT01004120|"~     The traditional risk factors for obesity are inappropriate diet, lack of exercise and genetic~     factors. However, recent observations have involved gut microbiota profiles as having an~     additional influence. In this case, there exists the possibility to modulate this through~     diet. Research has shown that the gut microbiota of both obese humans and mouse models of~     obesity is altered towards less beneficial one compared to lean counterparts. This raises the~     possibility of modulating the gut microbiota as a novel strategy in tackling the epidemic of~     obesity and diabetes sweeping the developed world. In addition, a more direct effect of~     high-fat induced disruption of the intestinal microbiota has also been seen with a murine~     model. Elevated circulating levels of lipopolysaccharide (LPS) a major building block and~     antigen of Gram-negative bacteria, was shown to generate a low grade chronic inflammation,~     termed metabolic endotoxemia, which then onsets insulin resistance. High-fat diets were shown~     to disrupt the Gram-negative intestinal populations of these animals, liberating LPS. The~     effects of prebiotics on the microbiota or metabolic syndrome (combination of disorders that~     increase the risk of developing cardiovascular disease and diabetes) in overweight adults~     have not been investigated thus far. The investigators therefore propose to investigate the~     effect of galactooligosaccharide (GOS) on the faecal microbiota and metabolic syndrome risk~     factors in overweight adults in a double-blind, randomised, placebo controlled, cross-over~     trial.~   "
195524|NCT01004107|"~     The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable~     Dermal Filler for hand treatment.~   "
195525|NCT01004094|"~     The primary purpose of this research is to test the effects of goal setting on fruit and~     vegetable goal attainment and consumption in a 10 episode video game. Factors associated with~     maintenance of behavior change will also be examined. Secondary purposes are to explore the~     impact of the intervention on psychosocial factors and the home environment. 400 parent-child~     pairs will be recruited for this research (800 participants total). Children will play the~     video game and participate in data collection activities. Parents will receive newsletters,~     have access to a healthy foods web site, and participate in data collection activities. A~     small subset will be randomly selected to participate in interviews about the intervention~     and its effect on the home food environment.~   "
195526|NCT01004081|"~     The purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing~     regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had~     progressed following treatment with a nonsteroidal aromatase inhibitor (AI).~   "
195527|NCT01004068|"~     Clomiphene citrate (CC) is the first-line therapy for infertile women with polycystic ovary~     syndrome (PCOS). Unfortunately, at least 20% of PCOS results are not responsive to CC.~     Structured exercise training (SET) and diet has been successfully employed to restore ovarian~     function and to improve reproductive outcomes in obese and overweight women with PCOS. The~     current study was aimed to test the hypothesis that a short-term SET program plus diet~     intervention can improve the ovarian response to CC in CC-resistant PCOS patients.~   "
195528|NCT01004055|"~     The purpose of this study is to determine whether a bioelectric wound dressing, a~     silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds~     resulting from curettage and electrodesiccation of skin lesions.~   "
195529|NCT01004042|"~     The primary objective of this study is to determine the alterations in quality of life and~     self-steem after BOTOX® injections in the glabella in depressed and non-depressed patients.~      The secondary objective of this study are:~        -  to elaborate a description of the muscles involved in the Veraguth Fold~        -  to evaluate depressive symptoms using Beck Depression Inventory before and after Botox®~          injections.~        -  to elucidate that depression is not a contraindication for botulinum toxin injections.~   "
195530|NCT01004029|"~     As part of the continuing effort to study the benefit and risks of 17P and preterm delivery,~     this study is designed as a multi-center, randomized, double-blind, vehicle-controlled~     clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of~     gestation in women with a singleton pregnancy, aged 18 years or older, with a previous~     singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic~     (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship~     and the effect of body mass index (BMI) on the PK of 17P.~   "
195531|NCT01004016|"~     To evaluate the efficacy and safety of KPS-0373 in patients with SCD.~   "
195532|NCT01004003|"~     The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC~     (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients~   "
195533|NCT01003990|"~     The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected~     subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS~     sponsored clinical trial and to collect long-term safety information on the treated~     population.~   "
195534|NCT01003977|"~     Single center registry of patients who have received a Xience V everolimus-eluting stent at~     the Washington Hospital Center, with the primary objective to assess clinical success and~     safety at 30 days, 6 months and 1 year post-implantation.~   "
195535|NCT01003964|"~     The primary objective of this randomized phase II study is to compare the Response Rate of~     each sequence of treatment approach in patients with advanced NSCLC. Additionally,~     development of gene expression profiles and genotypes that can predict response to commonly~     used chemotherapy may provide a unique opportunity to better utilize drugs shown to be~     effective in first- or second-line therapy. Here, the investigators will conduct a~     pharmacogenomic study to provide rational approach to the treatment of NSCLC by developing~     predictors of cisplatin (first-line agent) and pemetrexed or docetaxel (second-line agents)~     sensitivity and demonstrating the clinical value of identifying the most appropriate drug on~     the basis of sensitivity profile for the treatment regimen of each individual patient. Such~     an approach is likely to maximize response to chemotherapy and may change the current~     empirical paradigm of NSCLC therapy.~   "
195536|NCT01003951|"~     Lymphedema is an accumulation of lymphatic fluid in the tissues that causes swelling, most~     often in the arms and/or legs, and occasionally in other parts of the body. Lymphedema can~     occur when lymph vessels are damaged or lymph nodes are removed. Lymphedema can develop right~     after breast cancer treatment or weeks, months, or even years later. For many people,~     available treatments for lymphedema are not effective. Recent evidence suggests that~     acupuncture may help reduce the symptoms of lymphedema. The purpose of this study is to~     determine the effects of acupuncture on chronic lymphedema. This study will look further at~     whether acupuncture can reduce lymphedema and help us to understand immune changes that may~     be associated with improvements in lymphedema.~   "
195537|NCT01003938|"~     This is a single arm phase II study with a combination of Hycamptin® (topotecan) and~     erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent~     ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30~     patients will be enrolled in this study.~   "
195538|NCT01003925|"~     The purpose of this study is to develop a conjoint analysis-based questionnaire and decision~     aid for patients with osteoarthritis of the knee and to compare the responses of two groups~     of subjects, one receiving only printed information about knee osteoarthritis, the other~     participating in a computer-based adaptive conjoint analysis program.~   "
195539|NCT01003912|"~     The purpose of this study is to determine if it is safe to administer unrelated umbilical~     cord blood to pregnant women in their first trimester of pregnancy with a fetus that has a~     known diagnosis of certain lysosomal storage diseases. These diseases are known to cause~     severe and irreversible neurological disability in early infancy and which are lethal in~     childhood.~   "
195540|NCT01003899|"~     To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete~     Response, Partial Response) as determined by Response Evaluation Criteria in Solid~     Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the~     lung harbouring wild-type EGFR.~   "
195542|NCT01003873|"~     The aim of the study is to precise the effect of a large amount of weight loss induced by~     gastric bypass on the endocannabinoid system (plasma and adipose tissue) of morbidly obese~     patients and to determine the influence of a gastric bypass surgery compared to a lifestyle~     intervention with equivalent weight loss on the endocannabinoid system~   "
195543|NCT01003860|"~     A comparison was made regarding opioid analgesic usage immediately after elective shoulder~     replacement and for seven days at home between patients randomly given either 0.5% or 0.75%~     ropivacaine via interscalene block prior to surgery.~      It is hypothesized that no significant difference will exist between both groups with respect~     to pain medication used in the hospital and for a 7-day period at home.~   "
195544|NCT01003847|"~     The investigators hypothesize that fenofibrate and fatty acid may have different metabolic~     effects in hypertriglyceridemic patients~   "
195545|NCT01003834|"~     This is a randomized, controlled clinical trial to evaluate the effect of a computerized~     screening, assessment, and brief intervention on substance use in patients recruited from a~     primary care clinic. Study participants will be assigned to one of the following 4 study~     groups: computerized health screening alone (standard care) (SC); computerized~     assessment-only intervention (CA); computerized assessment followed by a computer-directed~     motivational intervention (CACI); or computerized assessment followed by a~     therapist-delivered motivational intervention (CATI). Data regarding substance use, medical~     and psychosocial functioning, and economic outcomes will be collected.~      The investigators hypothesize that patients randomized to CACI and CATI will be more likely~     to report drug abstinence at the 3-month follow-up visit and will show greater reductions in~     drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly,~     patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors,~     lower rates of medical and psychosocial problems, and increased economic gains at the 6-month~     follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes~     superior to those found for SC patients. A cost-effectiveness analysis will also be done~     comparing economic costs associated with CA, CACI and CATI and their relationship to~     substance use reductions and related improvements in medical and psychosocial outcomes at the~     6 month follow-up.~   "
195546|NCT01003808|"~     The purpose of this study is to determine the biological recommended dose of IMF-001.~   "
195547|NCT01003795|"~     Single-center registry of patients treated with at least one Promus, everolimus-eluting,~     Stent, with the primary objective to assess clinical success and safety at 30 days, 6 months~     and 1 year post-implantation.~   "
195548|NCT01003782|"~     Background: Antibiotic treatment of cholangitis often remains insufficient due to~     inappropriate antibiotic use or bacterial resistance.~      Objective: To evaluate the role of routine bile collection during endoscopic retrograde~     cholangiography (ERC) or percutaneous transhepatic cholangiography (PTC) for microbiological~     analysis in the antibiotic management of cholangitis and to identify risk factors of~     microbial growth.~      Design: Prospective, observational, diagnostic study.~      Setting: Hannover Medical School, Hannover, Germany. Patients and Interventions: Consecutive~     patients undergoing ERC/PTC for biliary complications after orthotopic liver transplantation~     , malignancy, primary sclerosing cholangitis, benign strictures and choledocholithiasis.~      Main outcome measurements: Microbiological examination of bile samples~   "
195549|NCT01003769|"~     This phase I/II trial studies the side effects and best dose of lenalidomide when given~     together with R-(-)-gossypol acetic acid and to see how well they work in treating patients~     with B-cell chronic lymphocytic leukemia (B-CLL) that has returned after a period of~     improvement (relapsed). Biological therapies, such as lenalidomide, may stimulate the immune~     system to attack cancer cells. R-(-)-gossypol acetic acid may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth and causing the cells to die. Giving~     lenalidomide with R-(-)-gossypol acetic acid may be an effective treatment for relapsed or~     refractory B-CLL. - Funding Source - FDA OOPD~   "
195550|NCT01003756|"~     This study is conducted in the Community Hospital in Svendborg (OUH Svendborg Sygehus) in~     collaboration with University of Southern Denmark and Odense University Hospital.~      The overall purpose of this study is to evaluate the effects of preoperatively delivered~     neuromuscular exercise on self perceived physical function, pain and Quality of Life in~     patients undergoing total hip or knee replacement. Secondary area of interest is physical~     performance, muscle function, and level of physical activity.~      The project will be conducted in two phases:~        -  A pilot project focusing on the logistics of the upcoming randomized controlled trial~          (RCT) and determination of test-retest reliability of specific muscle strength variables~          for the patients of interest~        -  A randomized and controlled trial where the intervention is preoperative neuromuscular~          exercise and the controls receive standard instructions.~   "
195551|NCT01003743|"~     Registry is designed to evaluate use of endolumenal tissue anchors for soft tissue~     approximation to repair a dilated gastric pouch and gastrojejunal anastomosis in~     post-Roux-En-Y gastric bypass patients presenting with weight regain. Registry will also~     assess tissue anchor durability.~   "
195552|NCT01003730|"~     This research is being done to determine if there is a way the investigators can improve the~     techniques that they use to assist patients with their breathing during surgery. The majority~     of surgeries require patients to concurrently undergo general anesthesia. This usually~     includes a breathing tube and a machine that breathes for the patient during the duration of~     the surgery. The doctors would like to investigate the effects of this type of anesthesia to~     healthy adult patients and whether they can improve the way they give general anesthesia to~     patients. The investigators plan to ask approximately 200 patients to participate. If the~     patients decide to participate in the study,some additions will be made to the standard~     anesthetic care they receive. The patients will additionally be monitored for adequate~     oxygenation in their blood as well as level of inflammation in their blood and lungs. The~     patients' breathing tube will be bathed with warm normal saline and suctioned twice during~     the operation. When these procedures are done the patients will be asleep and not be aware of~     what is happening.~   "
195553|NCT01003717|"~     Single-center registry of patients treated with at least one Endeavor, zotarolimus-eluting,~     Stent as the primary treatment for acute coronary syndrome at the Washington Hospital Center,~     with the aim of assessing clinical success and safety at 30 days, 6 months and annually for~     up to 3 years post Endeavor Stent implantation.~   "
195554|NCT01003704|"~     Phantom limb pain (pain originating from where an amputated limb once was) is a common~     occurrence after lower extremity amputations, with some sources noting incidence to be as~     high as 60-80% six months after surgery. This pain can eventually subside, however, cases~     have been reported of incidence 10 years after surgery. This pain is not only physically~     detrimental, but can also be psychologically detrimental after a difficult to accept change~     in the body. Prior studies have been performed using regional anesthetic techniques~     (including spinals and epidurals) and different medications to attempt to reduce the~     incidence of phantom limb pain, however, the data have been mostly inconclusive. Of interest,~     prior studies have not addressed peripheral nerve blocks, a method of anesthesia/analgesia~     more commonly employed for amputations recently. The purpose of our retrospective study is to~     look at the incidence of phantom limb pain at our institution over a two year period to~     determine if peripheral nerve blocks result in a significantly reduced incidence compared to~     other techniques (spinal, epidural, general anesthesia only). In addition, there is little~     data on relation of reason for amputation and presence of preoperative neuropathy and~     incidence of phantom pain. As secondary endpoints, the investigators wish to investigate if~     certain reasons for amputation (trauma, peripheral vascular disease, diabetes, and others)~     and/or neuropathy lead to a higher incidence of phantom limb pain. The results of this study~     could impact future management of patients who are to receive amputations and may lead to~     further prospective studies on the topics involved.~   "
195555|NCT01003691|"~     The purpose of this study is to determine the safety and tolerability of multiple doses of~     RN6G in subjects with advanced dry, age-related macular degeneration including geographic~     atrophy.~   "
195556|NCT01003678|"~     This is a Phase I trial for patients with intermediate or high risk myelodysplastic syndrome~     (MDS).~      The study agent, clofarabine, is produced by Genzyme Pharmaceuticals.~   "
195557|NCT01003665|"~     The purpose of this study was to compare the Continuous Non-invasive Arterial Pressure (CNAP)~     monitor with the gold standard of invasive arterial pressure monitoring during:~        1. induction and maintenance of general anaesthesia~        2. intensive care unit treatment of postoperative patients with an ASA 3 or 4 status~   "
195558|NCT01003652|"~     The purpose of this study is to evaluate the technical benefits, advantages and limits of the~     use of the Harmonic Focus curved shears in total thyroidectomy.~   "
195559|NCT01003639|"~     Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of~     elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991].~     Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age,~     and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about~     100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the~     optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop~     severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with~     unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic~     nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The~     purported goal of these therapies is to lower intracranial pressure; however, it is unclear~     which treatments work and by what mechanism. None of these strategies has been verified by~     properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific~     rationales to guide treatment decisions. This trial will study subjects who have mild visual~     loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to~     restore and protect vision, (2) follow subjects up to 4 years to observe the long-term~     treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be~     divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not~     required to complete the observational phase of the study, but will be asked to do so and~     consented for the observational phase of the study at the conclusion of the intervention~     phase (12 months).~   "
195560|NCT01003626|"~     The goal of this clinical research study is to learn about the side effects of measuring the~     tumor pressure in patients who have advanced melanoma and have not received chemotherapy.~     Researchers also want to learn if patients with a lower tumor pressure may respond better to~     chemotherapy.~   "
195561|NCT01003613|"~     Recurrent or secondary pterygium often has often a growing fibrovascular tissue more~     exuberant than the primary. Histological findings differ from the primary, since the typical~     changes in the degenerate connective tissue are absent. The strong immunoreactivity and~     release of basic fibroblast growth (b-FGF) in cultured fibroblasts of recurrent pterygia~     suggest that fibroblasts may play an important role in pterygium recurrence. Tranilast used~     is an antiallergic drug that has an inhibitory effect on the release of chemical~     transmitters, such as histamine and leukotrienes from mast cells as well as a suppressive~     effect on vascular permeability.This drug also reduces TGF-β1 production and collagen~     synthesis in various cells. Tranilast might reduce pterygium recurrence by suppressing TGF-β1~     synthesis in conjunctival fibroblast after pterygium surgery. The investigators want to~     confirm these findings and also compare the recurrence rate between the two types of surgery.~     Tranilast might be an alternative of mitomycin use, and also less toxic. This study aim to~     compare the effectiveness of preventing recurrence by using tranilast by topical~     subconjunctival administration previous to conjunctival autograft transplantation surgery in~     cases of primary pterygium, and will be perform clinical evaluation and TGF-beta-1~     immunohistochemical detection by the anti-TGF-beta 1 antibody as well as fibroblast culture.~   "
195562|NCT01003600|"~     We are doing this study to learn more about colon and rectal cancer survivors. We want to~     know if survivors want more information about life after cancer. Do cancer survivors want to~     know more about their own cancer? Do cancer survivors want to know about their treatment? Do~     cancer survivors want to know what health care they should get in the future? We want to know~     what information to give to cancer survivors when they finish treatment.~   "
195563|NCT01003587|"~     The purpose of this study is to assess the impact of disseminating information on comparative~     performance, along with actionable messages on how to improve health outcomes, to~     district-level decision-makers in India using a randomized, controlled design. This~     information should improve prioritization of health services by district health officers,~     budget allocation for health, and implementation of priority health services at the district~     level.~   "
195564|NCT01003574|"~     This study will test a 2-tiered tailored intervention and evaluation of cardiovascular health~     outcomes among survivors designed to inform childhood cancer survivors about their individual~     cardiac risk and follow-up recommendations and to provide motivational support for~     cardiovascular (CV) screening. This study will test if the addition of telephone motivational~     interviewing, tailored to behavioral constructs, is superior to the current standard of care~     in increasing survivors' CV screening.~   "
195565|NCT01003561|"~     The aim of this study is to evaluate the changes of venous flow, volume, and resistance in~     upper (basilic v.) and lower (popliteal v.) extremities of the elderly healthy patients~     compared with elderly hypertensive patients who undergoing spinal anesthesia for~     transurethral prostatectomy.~   "
195566|NCT01003548|"~     Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are~     cultured in microdrops of culture media in incubators with controlled temperature, humidity~     and atmosphere. However, these culture systems are static, while in vivo the initial growth~     of the embryo takes place in the uterine tube and they are submitted to a dynamic~     environment. The aim of this study is to compare the embryo development on days 2 and 3 of~     culture morphological features of embryos under static and dynamic(microfluidics) systems of~     culture.~   "
195567|NCT01003535|"~     Parkinson´s disease is based on a Lewy body degeneration of cerebral and extracerebral~     neurons. This Lewy body degeneration includes cerebral cholinergic neurons besides~     dopaminergic neurons.~      In previous studies the investigators found that some clinical parkinsonian symptoms -~     primarily hypokinesia and rigidity - significantly correlate with the dopaminergic~     nigrostriatal degeneration which was quantified by dopamine transporter imaging. In contrast~     to that, resting or postural parkinsonian tremor does not correlate with the dopaminergic~     nigrostriatal degeneration. Obviously further cerebral changes - for instance possible~     changes / degeneration of cerebral cholinergic neurons - contribute to parkinsonian tremor.~      In this study the investigators apply cerebral 5-IA-85380-SPECT to quantify the local density~     of cerebral nicotinergic cholinergic receptors in patients with Parkinson´s disease. The~     investigators will correlate the results of cerebral 5-IA-85380-SPECT with the clinical~     parkinsonian main symptoms hypokinesia, rigidity and primarily resting and postural tremor.~     In particular, it is of interest whether changes of cerebral cholinergic neurons are involved~     in the generation of parkinsonian tremor.~   "
195568|NCT01003522|"~     To investigate whether the use of airways stents (metal tubes to open and keep open narrowed~     airways) together with the standard treatment increases the proportion of patients who can~     complete a 6min walking distance (6MWD) test at 2 weeks +/- 2days in patients with~     breathlessness due to lung cancer, when compared to standard treatment alone.~   "
195569|NCT01003509|"~     This is a new inguinal hernia repair technique.~   "
195570|NCT01003496|"~     The purpose of this 2 year study is to conduct a fully powered effectiveness trial comparing~     recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly~     assigned to Treatment as Usual (TAU) or TAU + Long-Term Recovery Management (LTRM).~   "
195571|NCT01003483|"~     The purpose of this study is to compare the influence of Orlistat and Metformin on obesity~     treatment in obese PCOS women.~   "
195572|NCT01003470|"~     The purpose of this study is to evaluate the therapeutic effect of acupuncture method of~     Xing Nao Kai Qiao for paralysis as an apoplectic sequela in a multicenter randomized and~     controlled clinical trial and to compare the efficacy between acupuncture and rehabilitation~     therapy. In addition, evaluating the trial in the view of medical economics.~   "
195573|NCT01003457|"~     In the last decade, several authors proposed ultrasound measurement of Bladder wall thickness~     (BWT) for the screening of the voiding dysfunction and of the detrusor overactivity (DO). The~     aims of the investigator prospective study were:~        -  to compare the ultrasonographic measurement of BWT in women with DO vs women with other~          urodynamic diagnosis in a very large population.~        -  to verify whether the BWT in women with DO can be different in the clinically or~          urodinamically different forms of DO.~   "
195574|NCT01003444|"~     Biopsies of the outer thigh muscle and serum samples will be collected from untreated healthy~     subjects. These biological samples will be provided to the Diabetes Research Unit~     Translational Biomarker Laboratory for use in developing and validating human muscle malonyl~     CoA and serum malonate biomarker assays.~   "
195575|NCT01003431|"~     This study will evaluate the immunogenicity and safety of the pertussis component of DTwP~     (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or~     Rotatrix™.~   "
195576|NCT01003418|"~     The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1~     candidate vaccine administered in children aged between 8 and 12 weeks at the time of first~     vaccination.~   "
195577|NCT01003405|"~     To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients~     with overactive bladder.~   "
195578|NCT01003392|"~     Coffee is a worldwide drink, been part of any culture. There are some concerns about effects~     of coffee on the health. Recently, epidemiological studies have shown benefits of coffee~     drinking to diabetics and also to prevent diabetes in populations. We aim to understand some~     effects of coffee and not only caffeine over vascular system, in special coronary artery~     disease patients, diabetics end normal people.~   "
195588|NCT01003262|"~     Syncope, defined as a transient loss of consciousness, accounts for over 700,000 annual U.S.~     emergency department visits and may herald a life-threatening condition in older adults~     (age≥60 years). Existing risk prediction instruments cannot reliably identify who among such~     older patients can safely be discharged home from an emergency department. As a result, the~     majority of older patients without a clear cause for syncope are hospitalized for diagnostic~     evaluation. However, current admission practices are characterized by low diagnostic yield,~     do not clearly improve outcomes, and account for over $2.4 billion in annual hospital costs.~     Most admitted patients are discharged within 48 hours, and approximately 50% of patients do~     not have an identified cause of syncope after their hospitalization.~      The implementation of an expedited and standardized Emergency Department Observation Syncope~     Protocol (EDOSP) may safely reduce hospitalization of older patients with syncope. The~     investigators propose a pilot randomized trial to implement and evaluate EDOSP at two~     emergency departments. This study has the following exploratory Specific Aims:~        1. To compare admission rates and length-of-stay associated with EDOSP to standard care.~        2. To compare serious outcomes rates associated with EDOSP to standard care.~        3. To compare quality-of-life associated with EDOSP to standard care.~        4. To compare the incremental costs and cost-effectiveness of EDOSP to standard care.~      Over a one-year period, 120 intermediate-risk older adults who present with syncope at the~     two study sites will be randomized to 1 of 2 arms: 1.) intervention arm: expedited and~     standardized EDOSP care; or 2.) control arm: routine care consisting of admission from the~     emergency department.~      If this pilot trial suggests that EDOSP can safely reduce admissions, then the investigators~     will plan a larger study powered to evaluate clinical, quality-of-life, and economic~     outcomes. A successful EDOSP intervention would have important clinical policy implications~     and improve the emergency department care of older adults with syncope.~   "
195579|NCT01003379|"~     Schizophrenia affects approximately 1% of the population worldwide, and in about 80% of~     cases, it is a lifelong, disabling illness. It is a multi-dimensional disease that is~     associated with symptoms that have been characterized as positive, negative, and cognitive.~     CDS is a core feature of schizophrenia, and most individuals with schizophrenia exhibit~     cognitive impairment. Attention disorders, slow information processing, working memory~     disorders, and lack of flexibility for adaptive strategies are symptoms of cognitive~     impairment that have a devastating impact on the function, employment, and social status of~     patients with schizophrenia.~      Older typical neuroleptic medications (e.g., haloperidol, fluphenazine) do not improve~     cognition. In fact, haloperidol has been shown to induce cognitive impairment in~     schizophrenic patients.~      Novel atypical antipsychotics, such as risperidone, clozapine, and olanzapine, seem to~     produce gains in cognition. This improvement may reflect a diminution of extrapyramidal side~     effects of the typical high potency neuroleptics. Alternatively, it might reflect more~     effective symptom reduction by the novel antipsychotics, or direct cognitive enhancement~     through the effects of the newer agents on a variety of neurotransmitters, their receptors,~     and gene expression. Even when the newer antipsychotic medications improve cognition, they do~     not normalize it.~      Presently, there are no approved therapies for CDS. However, in schizophrenic patients,~     nicotine improves multiple cognitive domains, including working memory and attention.~     Furthermore, based on a strong body of evidence ranging from genetic mapping to clinical~     trials, the alpha7 NNR subtype has emerged as a primary therapeutic target relevant to CDS~     and other core symptoms of schizophrenia~   "
195580|NCT01003366|"~     To test the hypothesis that approaching the internal jugular vein with the needle bevel down~     would produce less injury to the vessel wall compared to the bevel up approach during central~     venous catheterization.~   "
195581|NCT01003353|"~     The study aims to investigate the effects of strength training on maximal strength, walking~     ability and neural function in chronic stroke patients. The strength training intervention in~     this study is different to all previous interventions for stroke patients.~      Maximal Strength Training (MST) involves weights of up to 90% of the participants 1~     repetition maximum and has a focus on the explosive development of force. This study will use~     these principles for unilateral leg press and plantarflexion exercises. Only 2 previous~     studies have investigated high intensity strength training for stroke patients and they used~     intensities of 80% 1RM. Previous MST interventions have shown large increases in strength,~     rate of force development and this has transferred to improved walking economy.~      The investigators predict that MST will give large increases in strength, improved rate of~     force development (RFD) and walking economy. The investigators expect that better neural~     function will account for the improvements. This study could provide evidence for the~     adoption of a completely different method of strength rehabilitation for stroke survivors.~   "
195582|NCT01003340|"~     The investigators propose to test the hypothesis that a home-based asthma intervention, the~     Wee Wheezers program, delivered by the Community Health Workers and tailored to the needs of~     the investigators community, will improve anti-inflammatory medication adherence, parental~     asthma knowledge and management behaviors, which in turn will reduce asthma morbidity~     (defined as days with asthma symptoms) and health care utilization (defined as asthma-related~     Emergency Department visits) among low-income, minority children with persistent asthma in~     the Bronx.~   "
195583|NCT01003327|"~     The intention of this study is to compare the performance of the single-use I-gel laryngeal~     mask with the classic laryngeal mask in 50 patients with a BMI>25 during elective surgery.~     Primary outcome is the leak pressure. Secondary outcomes include ease and duration of~     insertion.~   "
195584|NCT01003314|"~     This study aims to test the safety of two new malaria vaccines AdCh63 MSP1 and MVA MSP1.~     These vaccines consist of inactivated viruses which have been modified − so they cannot~     reproduce (replicate) in humans, and also to include genetic material (genes) for malaria~     proteins which are expressed by the malaria parasite during blood stage infection. The~     vaccines are designed to stimulate an immune response to these malaria proteins~     (immunogenicity describes the nature and magnitude of this immune response), to provide~     protection against malaria infection. This protection has been demonstrated in nonhuman~     studies. Although these vaccines have not been given to humans before, similar vaccines using~     the same viruses with different malaria genes have been given to humans before. In these~     studies, the vaccines have been shown to be safe. They have also provided evidence from~     laboratory tests of immunogenicity. In this study the investigators main aim is to ensure~     these new vaccines given alone and in combination are safe. The investigators will increase~     the dose of the first vaccine (AdCh63 MSP1) given to volunteers if the initial dose is safe.~     The investigators also wish to ensure that challenging a small number of volunteers who have~     received both vaccines with malaria infection from the bites of infected mosquitos(sporozoite~     challenge) is safe. Sporozoite challenge has been widely used in humans to test the~     effectiveness of malaria vaccines and is considered a well established, reliable, predictable~     and safe system.In the study the investigators will also look for evidence of immunogenicity~     of these new vaccines, and whether there is any delay to developing malaria following~     sporozoite challenge. The study will be conducted at the University of Oxfords Centre for~     Clinical Vaccinology and Tropical Medicine (CCVTM). The challenge part of the study will take~     place at the insectary at Imperial College, (Infection and Immunity Section)in London.~   "
195585|NCT01003301|"~     This research is being done to study the effects of the drug omalizumab (Xolair) in people~     with cat allergies. The investigators will use omalizumab to study changes in the cells in~     the nose, cells in the blood and cells in the skin that cause allergies. The investigators~     will compare the changes in the nose to changes in the skin and blood cells.~      Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal~     allergen challenge late-phase eosinophil count in nasal brushings at the time when blood~     basophils have become hypo-responsive to in vitro allergen exposure.~   "
195586|NCT01003288|"~     Haukeland University Hospital has approximately 8000 employees many of whom will be in the~     front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and~     immunogenicity study in these subjects~   "
195587|NCT01003275|"~     The purpose of this study is to determine if treatment with paricalcitol, an active form of~     vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic~     Kidney Disease (CKD).~   "
195614|NCT01002924|"~     This extension protocol is for those subjects that have completed the allowed duration of~     participation in an Endocyte-sponsored clinical trial of EC145 (vintafolide) and have~     continuing evidence of clinical benefit (stable disease or better) at the time that they~     completed participation in that study.~   "
195615|NCT01002911|"~     The goal of the pilot study is to compare conventional antibiotic therapy to an aggressive~     antibiotic therapy plan for the prevention of arrhythmia device infection in high-risk~     patients undergoing arrhythmia device procedures. All antibiotics are approved for use and~     readily available.~   "
195589|NCT01003249|"~     Dysfunctional voiding is often associated with constipation. The association of constipation~     with urologic pathologic processes has previously been described since the 1950's, but it was~     only over the past decade that clinicians have paid more attention to this relationship and~     recognized it existence with the term dysfunctional elimination syndrome (DES). This term is~     used to reflect the broad spectrum of functional disturbances that may affect the urinary~     tract including that of functional bowl disturbances and can be classified as follows:~        -  Functional disorder of filling: overactive bladder, over distention of bladder or~          insensate bladder, which may be associated with fecal impaction or rectal distention~          with infrequent bowel movements~        -  Functional disorder of emptying: over-recruitment of pelvic floor activity during~          voiding causing interrupted and/or incomplete emptying also associated with defecation~          difficulties due to non- relaxation of the puborectalis muscle, dyssynergic defecation~          or pain with defecation Several different therapeutic options have been used for~          patients with dysfunctional voiding mainly to decrease bladder outlet obstruction. These~          treatments including, alpha adrenergic antagonists, and botulinum toxin are less than~          optimum. One possible explanation for these drug failures includes the inability of~          these medications to relax the striated muscles of the pelvic floor necessary for~          voiding.~      To date there has been no data to evaluate the role of baclofen on the striated muscle of the~     external anal sphincter, essential in the defecation process.~   "
195590|NCT01003236|"~     There is considerable evidence that increased blood glucose results in the generation of~     reactive oxygen species, ultimately leading to increased oxidative stress in a variety of~     tissues. This may lead to the activation of stress-sensitive intracellular signaling~     pathways, causing cellular damage and late complications of diabetes including renal injury.~     Although the investigators understanding of how hyperglycemia-induced oxidative stress~     ultimately leads to tissue damage has advanced considerably in recent years, effective~     therapeutic strategies to prevent or delay the development of this damage remain limited. The~     flavonoid complex silymarin, an extract from the milk thistle, and its major pharmacological~     active component silibinin are free radical scavengers and potent membrane stabilizers by~     preventing lipid peroxidation. Furthermore, during early stages of diabetes, flavonoids~     minimize oxidative stress, and inflammation which represent important factors in the~     development of diabetic nephropathy.~      In this study the investigators plan to evaluate the renoprotective effect of milk thistle~     extract on type II diabetic patients with kidney disease.~   "
195591|NCT01003223|"~     Cardiovascular disease is a major cause of death in hemodialysis (HD) patients and is~     associated with widespread vascular calcification. There is a consensus that the chronic~     overload of calcium and phosphorus is a major factor in vascular calcification.~     Hyperphosphatemia, deleterious in dialysis patients, is aggressively monitored and treated.~     Phosphate binders - designed to bind dietary phosphate and thus prevent its absorption, are~     ubiquitous in the dialysis patient population, and calcium-based phosphate binders are often~     first line therapy because they are tolerated well by the patients and low in cost. Phosphate~     Kinetic Modeling (PKM) is a tool to help physicians manage a hemodialysis patient's phosphate~     level. Once a subject consents to participate in the study, the subject's dietary phosphate~     intake will be estimated and the appropriate dose of the phosphate binder calcium acetate~     (PhosLo) will be recommended accordingly. If necessary, the Ca++ concentration of the~     dialysate will be changed to remove any excess calcium absorbed as the result of an increase~     in the PhosLo prescription to control phosphorus.Ongoing recommendations regarding oral~     phosphate binders dialysate calcium will be made using a computer generated algorithm.~   "
195592|NCT01003210|"~     The purpose of this study is to determine if a commercially available homeopathic ear drop~     preparation is effective in reducing symptoms in children 6 months - 11 years old with acute~     otitis media in whom the health care provider has recommended that antibiotics not be~     immediately administered. A total of 150 study patients with otitis media will be randomized~     to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It~     is postulated that children using the ear drops will have more rapid resolution of symptoms~     and need fewer antibiotics than those randomized to not receive the ear drops.~   "
195593|NCT01003197|"~     To develop and validate a score to predict serious complications following liver resection~     using pre-operative risk factors.~   "
195594|NCT01003184|"~     The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin~     detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and~     patient reported outcomes.~   "
195595|NCT01003171|"~     This study is to examine the pharmacokinetics, absorption and serum concentrations of MCS and~     other components after once-daily oral dosing of MCS.~   "
195596|NCT01003158|"~     The main purpose of this study is to determine if AZD8931 can be safely administered in~     Japanese patients alone and in combination with weekly paclitaxel. The study will be~     conducted in two parts: a monotherapy and a combination part, where safe doses of study~     treatment will be determined.~   "
195597|NCT01003145|"~     This was a randomized, laboratory-blinded study in healthy male and non-pregnant female~     designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated~     influenza H1N1 vaccine (AdimFlu-S). In the adult cohort, all volunteers were randomized in a~     1:1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart, 2~     injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart or 1 injection of AdimFlu-S~     (A/H1N1) 15 mcg HA. In the elders cohort, all volunteers were randomized in a 1:1 ratio to~     receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart or 2 injections of~     AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart.~      Following immunization, safety was measured by assessment of adverse events for 6 weeks~     following the first vaccination, serious adverse events and new-onset chronic medical~     conditions through 7 months post first vaccination; and reactogenicity to the vaccines for 7~     days following each vaccination. Immunogenicity testing included hemagglutinin inhibition~     (HAI) testing on serum obtained before first vaccination, and three and six weeks after first~     vaccination.~   "
195616|NCT01002898|"~     To assess 48-week treatment responses, tolerability, and steady-state minimum plasma~     concentrations of ritonavir-boosted lopinavir monotherapy for salvage therapy in HIV-1~     infected patients who failed antiretroviral regimens containing NRTI and NNRTI.~   "
195598|NCT01003132|"~     This research investigates a new talking therapy aimed at helping people to come to terms~     with the experience of psychosis. The new therapy is called Acceptance and Commitment Therapy~     for psychosis (PACT). PACT aims to help people:~        1. Develop a sense of mindfulness. Mindfulness allows you to be fully aware of your~          here-and-now experience, with an attitude of openness and curiosity. It is hoped that~          this will help reduce the impact of painful thoughts and feelings.~        2. Take effective action that is conscious and deliberate, rather than impulsive. It is~          hoped that this will allow people to be motivated, guided, and inspired by the things~          that they value in life.~      It is hoped that PACT will help to reduce the level of distress that individuals diagnosed~     with psychosis have been experiencing and help them to stay well in the future.~   "
195599|NCT01003119|"~     The purpose of this grant is to develop and test a proven computer based quality~     improvement/behavior change e-Health system (CHESS--Comprehensive Health Enhancement Support~     System) to help prevent relapse in alcohol dependent patients being discharged from~     residential treatment. The investigators' primary hypothesis is that ACHESS (Addiction CHESS)~     will improve competence, relatedness and autonomy, which will reduce the days of risky~     drinking over a 12-month period.~   "
195600|NCT01003106|"~     The primary Objective of this study is to evaluate the safety and tolerability of intraocular~     injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal~     vein occlusion.~   "
195601|NCT01003093|"~     The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit~     vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior~     history of TB disease or known prior exposure to TB~   "
195602|NCT01003080|"~     The use of Aquamantys during total knee arthroplasty will reduce drain output and the~     necessity for blood transfusions.~   "
195603|NCT01003067|"~     Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation~     after laparotomy (Group 1) in a randomized control trial compared with patients with standard~     abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the~     feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound~     infection and incisional hernia.~   "
195604|NCT01003054|"~     The goal of this clinical research is to learn if treatment with high-dose busulfan and~     cyclophosphamide plus autologous bone marrow transplantation followed by treatment with~     Gleevec (imatinib mesylate) is effective in treating chronic myelogenous leukemia (CML).~      Objectives:~        1. To assess the efficacy of high dose busulfan-cyclophosphamide and autologous~          hematopoietic transplantation with post transplant Imatinib mesylate for the treatment~          of CML. The primary endpoint of the study is to determine the proportion of patients~          with CML alive in cytogenetic remission at one year following this treatment.~        2. Secondary endpoints are time to progression and survival.~   "
195605|NCT01003041|"~     The purpose of this study is to record voice samples of infant's mothers, process in samples~     to a phonetic musical piece, play the phonetic musical piece to 4-10 month old infants, and~     then test the infants in a conditioned head turning test in lab, and to analyze the results.~   "
195606|NCT01003028|"~     This study is intended to evaluate the effect of decreasing the maximum plasma concentration~     target of remifentanil of the Target Controlled Infusion system on the the incidence of major~     and minor side-effects.~   "
195607|NCT01003015|"~     The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink~     or delay the growth of tumors in patients with unresectable liver cancer.~   "
195608|NCT01003002|"~     Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and~     uncontrolled movements called dyskinesias (LID). The severity of these movements can range~     from subtle to extremely debilitating. These movements may or may not interfere with normal~     activities such as putting on a coat or brushing ones teeth. Current estimates of the~     occurrence rate of LID range from 12 % to 100% after one year of levodopa treatment. These~     estimates used reporting mechanisms such as self-report and doctor-reported. These reporting~     mechanisms are not reliable. We will use an objective measure of dyskinesia in the first 5~     years of treatment for Parkinson's disease. The purpose of this protocol is to use an~     objective measure to estimate dyskinesia onset.~   "
195609|NCT01002989|"~     Measurement of the ankle-brachial index (ABI) with the oscillometric device WatchBP Office~     will be assessed compared to the reference method (Doppler).~      Ninety three adult subjects assessed for hypertension, treated or untreated, with complete~     study data were included. Data on the presence of cardiovascular (CV) disease and classical~     CV risk factors were recorded.~      All the ABI measurements of each individual participant will be performed by the same~     observer in a randomized order (concerning Doppler and WatchBP)~   "
195610|NCT01002976|"~     Omalizumab is an anti-IgE recombinant humanized monoclonal antibody.The efficacy and~     tolerability of omalizumab have been demonstrated in patients with moderate-to-severe and~     allergic (IgE-mediated) asthma. Clinical benefit with omalizumab is observed when serum free~     IgE levels are reduced to 50 ng/mL or less. However, although the causal role of IgE in~     allergic disease is well established, the relationship between free IgE and clinical symptoms~     of asthma has not been accurately quantified. Recent study demonstrated that omalizumab and~     free IgE concentrations are correlated with clinical outcomes. In non responder to omalizumab~     the clinical symptoms show random fluctuations around baseline without any tendency toward~     improvement despite adequate suppression of free IgE. In these patients it may be the ratio~     of specific IgE to total IgE or inter-patient variability in the expression of FceRI on~     effector cells that define whether the patient will respond or not to omalizumab.~      This current study is designed to evaluate the mechanisms of responsiveness to omalizumab~     measuring the free IgE, specific IgE and the level of FceRI expression on the effector cell~     and the correlation to clinical response.~   "
195611|NCT01002963|"~     The purpose of this study is to investigate safety and toleration of single oral doses as~     well as the time course of PF-04418948 concentration in the blood following dosing by oral~     solution.~   "
195612|NCT01002950|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.~   "
195613|NCT01002937|"~     The purpose of this project is to analyze tumour tissue from a group of subjects with renal~     cell carcinoma, who have been treated at the Royal Marsden Hospital.~   "
195617|NCT01002885|"~     This study is being done to identify if certain sequences (patterns) of key genes (called~     polymorphisms) may predict a response to fertility medications. The investigators will also~     determine if the individual response to fertility medications affects pregnancy rates in~     in-vitro fertilization.~   "
195618|NCT01002872|"~     The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus~     binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD).~      Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease~     and patient mortality.~   "
195619|NCT01002859|"~     Observe the effect of preliminary cyclosporine administration on different markers of cardiac~     ischaemia led by the aortic cross-clamp during coronary artery bypass surgery with~     Cardiopulmonary bypass.~   "
195620|NCT01002846|"~     This is randomised, controlled study about effects of acupuncture on blood pressure and~     endothelial dysfunction in stage I hypertension patient without medication. Subject will~     receive 8 weeks of either acupuncture or sham acupuncture, measuring FMD and blood test~     before and after treatment.~   "
195621|NCT01002833|"~     Plasmodium falciparum isolates display a wide genetic diversity with possibly different~     properties to induce immune responses. These properties could directly influence the ability~     to induce protective efficacy. Since 1998 an experimental human malaria infection model at~     the Radboud University Nijmegen Medical Center (RUNMC) has been very successful in answering~     questions with regards to immunological mechanisms of human Pf infection. To date only the~     NF54 strain of Pf has been deployed in this Nijmegen model. However, investigation of~     heterologous Pf challenge is not only highly informative for our basic understanding of~     induction of immune responses but also provides an essential model for protective capacity~     testing in the clinical development of candidate malaria vaccines. Recently, the parasite~     culture laboratory of the RUNMC has been able to overcome technical hurdles to produce~     infectious mosquitoes of two genetically different isolates from different geographical~     regions to increase the portfolio for Phase IIa trials. These isolates, PfA and PfB will be~     compared with the NF54 strain for parasitic, immunological and clinical features in humans.~   "
195622|NCT01002820|"~     This study is designed to provide ganaxolone to those patients deriving significant benefit~     from current treatment in protocol 1042-0601.~   "
195623|NCT01002807|"~     To assess the relative bioavailability of dapagliflozin and metformin from the two FDC~     formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to~     coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in~     healthy subjects in a fasted state.~   "
195624|NCT01002794|"~     This study is conducted as a collaboration between NAR, Orthopedic Department, Oslo~     University Hospital,Ullevaal, Hjelp24Nimi Oslo, Norway, and University of Southern Denmark,~     Odense, Denmark.~      The investigators hypothesize that exercise is more effective than arthroscopic partial~     meniscectomy: a) on self-reported outcomes, functional performance and muscle strength in~     middle-aged patients subsequent to arthroscopic partial meniscectomy for a degenerative~     meniscus tear, and b) in preventing further development of knee osteoarthritis (OA).~   "
195625|NCT01002781|"~     Patients with adult's Still disease suffer from acute inflammatory symptoms such as fever,~     arthritis, rash, and acute phase response often requiring high dose corticosteroids. In view~     of several case reports which have shown dramatic improvement in patients treated with~     Tocilizumab and a phase 2 study of this drug in children with Still's disease, the objective~     of the current study is to assess the efficacy and safety of Tocilizumab in patients with~     adult's Still disease.~   "
195626|NCT01002768|"~     This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the~     hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in~     subjects with type 1 diabetes.~      The trial is designed as a two-period, crossover trial where the trial participant is~     randomised to one of two treatment periods.~   "
195627|NCT01002755|"~     The goal of this clinical research study is to learn if the combination of lenalidomide and~     ofatumumab can help to control CLL or SLL in patients who have already received therapy. The~     safety of this drug combination will also be studied.~   "
195628|NCT01002742|"~     The study is a Phase III, randomized double blind, placebo controlled, and trial evaluating~     the addition of Mycophenolate mofetil (MMF) vs. placebo to systemic corticosteroids as~     initial therapy for acute Graft Vs Host Disease (GVHD). The primary endpoint will be GVHD~     free survival at Day 56 post randomization.~   "
195629|NCT01002729|"~     This trial asks the question: do people of much greater than average body weight need more of~     a drug called oseltamivir than current recommendations suggest. Oseltamivir is a drug given~     to people who have influenza, and currently is also being used to fight the new H1N1~     influenza. Some people of larger than average body weight require larger amounts of drugs to~     see the same effects as others of an average body weight. No studies have ever been conducted~     looking at the possibility of oseltamivir being one of those drugs. Our Study's hypothesis~     states that those of an above average body weight will have different amounts of drug in~     their blood than those of people of normal body weight if they are given the normal amount~     prescribed for influenza. Our study will give oseltamivir to twenty people for 7 days. Half~     of the people will be of normal body weight and the others will be of a much higher than~     normal body weight. Using blood samples the investigators will determine if the amounts of~     oseltamivir are significantly lower in the blood of patients in the above normal body weight~     group.~   "
195630|NCT01002716|"~     The efficacy of vaccination against influenza in patients with rheumatoid arthritis has been~     assessed using humoral response. However, the cellular immunity is another important pathway~     of response to vaccination. The purpose of this study is to evaluate the degree of cellular~     immunity response to influenza vaccination. Patient with rheumatoid arthritis and healthy~     controls will participate in this study , will undergo a clinical evaluation the day of~     vaccination and 4 weeks after. The humoral and cell immunity response will be assessed the~     day of vaccination and 4 weeks later~   "
195631|NCT01002703|"~     Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.~   "
195663|NCT01002287|"~     This will be a prospective, multi-center, randomized, single blind study to collect and~     evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant~     to good surgical technique for the reduction of postoperative adhesion formation following~     major open abdominal surgery.~   "
195632|NCT01002690|"~     The study is part of a research programme into mechanisms of asthmatic airway obstruction,~     focusing on the role of lipid mediators such as the prostaglandins.~      To this end the effect of a non-steroidal anti-inflammatory drug, the selective COX-2~     inhibitor etoricoxib, will be evaluated in the allergen challenge setting in twelve subjects~     with intermittent allergic asthma. Active treatment for 10 to 13 days will be compared with~     an identical study period with no treatment in a cross-over, randomised design. Rising dose~     allergen challenges will be performed on three occasions to assess possible changes in~     airways responsiveness. Sampling of blood, urine, saliva and sputum will be done to allow for~     analyses of the production of prostaglandins and other lipid mediators, of the efficacy of~     COX-2 inhibition as well as of regulation of immune cells.~      It is hypothesized that inhibition of COX-2 by virtue of inhibition of bronchoprotective~     prostaglandin E2 leads to a slightly exaggerated airway response to allergen exposure.~   "
195633|NCT01002677|"~     The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical~     behavioral trial of advocacy skill training for individuals with traumatic brain injury~     (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a~     4-session advocacy training program to improve behavioral advocacy skills compared to~     self-directed advocacy training of the same session frequency. Groups will be randomly~     assigned to either a programmed group or a self-directed group in collaboration with the~     Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study~     period. The primary outcome is pre-post measures of written and verbal advocacy skill~     measured by the Advocacy Behavior Rating Scale.~      It is hypothesized that subjects who receive programmed advocacy training will show greater~     positive change on pre-post measures of advocacy skill measures than subjects receiving~     self-directed training.~   "
195634|NCT01002664|"~     The hypothesis of the study is to examine whether MCS-2 is safe and effective in the~     treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.~   "
195635|NCT01002651|"~     The investigational study product used in this clinical trial is a soft drink containing an~     arabinoxylan-oligosaccharides (AXOS) preparation extracted from wheat bran (hereafter called~     Wheat Bran Extract, WBE).~      The objective of this study is to analyze the effect of the intake of two WBE doses on~     various parameters of gastrointestinal health. Additionally, safety was analyzed using~     treatment emergent Adverse Events (AEs) and clinical blood parameters.~   "
195636|NCT01002638|"~     Fingers amputations are very common injuries among the patients arriving at the Emergency~     Department. Fingertips amputations classified in 2nd and 3rd zones, in accordance with~     Rosenthal's classification (after the solum unguis), constitute a large proportion of them.~     The treatment aims at restoring a pulp with its sensitivity and a good subcutaneous fat~     tissue. The usual care of these amputations is a surgical treatment: it consists of pulp~     reconstruction by a flap (for example palmar V-Y advancement flaps of Atazoy). These~     technique involve hospital admission, brachial plexus anaesthesia, a surgical approach with~     cicatrix and donor site morbidities, postoperative cares, post-surgical pain management. And~     of course attention must be paid to the risks of postoperative complications related either~     to anaesthesia and/or to surgery, like necrosis, infection, and others. We have developed a~     nonoperative treatment for fingertips amputations: the occlusive dressing. It's a technique~     that has been known for about twenty years, and that is currently developed by the teams SOS~     main of Professor Liverneaux in Strasbourg and of Professor Obert in Besançon. It consists of~     the occlusive application of two Tegaderm®, a plastic dressing. Then the finger macerates in~     an anaerobic medium, and could develop an uncomfortable smell induced by maceration process.~     The first results described by the preclinical studies of these two groups look satisfying on~     both the functional aspect (sensibility) and the aesthetic component (preservation of the~     finger length and curve), as well as for healing that occurs without infection. Moreover, the~     length of the treatment is of about only three or four weeks, and its cost is very low by~     comparison with the cost of the surgery itself. Nevertheless this technique is still not very~     common, and it has been reported in only five references in the literature [Mennen & Al.,~     Farrell & Al., Lee & Al., Allen & Al., Tago Hiroyuk & Al.]. On the other hand, the mechanism~     of action and/or the active components of this occlusive dressing have not yet been the~     objects of extended studies. An explanatory hypothesis is that some anaerobic germs and/or~     growth factors might play an active role in the process. However, they have not been~     identified yet. The aim of our study is to validate through clinical and biological criteria~     this non operative method and to compare with surgical treatment. The study will be held in~     the Hand Department of the University Hospital of Strasbourg, under the direction of the Pr~     Liverneaux. It will imply the collaboration of the laboratory of medical bacteriology~     directed by Pr Piemont, and the research department of INSERM (Parogène laboratory) will~     focus on the biochemistry. From a clinical point of view, a certain number of objective~     functional criteria will be measured: the pain will be evaluated by a visual analogic scale~     and the DN4 scale; the functional disability will be measured with the french version of the~     Disability Arm Shoulder Hand of Dubert; the pulpar 3D volume will be calculated from the~     numerical pictures with a computerized file, the cutaneous depth will be measured by 3D U.S;~     the tactile sensibility will be tested by standardized monofilaments and Weber's test and the~     dermatoglyphics of both handsides will be compared. In addition, the subjective feeling of~     the patients will be recorded through a visual and analogical scale of satisfaction. The~     purpose of the biological component of the study will be to put into light and to identify~     the components that are active in the process. This will be performed by the direct~     examination and by bacteriological cultures, and will look for the anaerobic, aerobic germs~     and the yeasts.The biochemical studies will first include a non specific search of growth~     factors, cytokines and interleukins. In a second step, specific researches will be undertaken~     if necessary in accordance with the results of the first investigations. By this study, the~     investigators would like to scientifically confirm the efficiency of this method with~     objective as well as subjective criteria, and to identify the underlying biomechanisms of the~     process.~   "
195637|NCT01002625|"~     PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats,~     which suggests that PF-04457845 is active in rat's brains. This study is designed to see~     whether this is also the case in man.~   "
195638|NCT01002612|"~     To reassess nutritional status of HIV-infected Thai children living in the family style~     community after receiving nutrition support program for 6 months.~   "
195639|NCT01002599|"~     This is a randomized controlled study in which morbidly obese patients undergoing bariatric~     surgery will be recruited in the preoperative clinic. Patients will be randomized into 2~     groups to receive oxygen with Boussignac TM continuous positive airway pressure (CPAP) or~     conventional Venturi mask postoperatively immediately after extubation. The objective of the~     study is to examine if Boussignac TM CPAP results in improved oxygenation versus Venturi face~     mask when it is applied immediately after extubation in morbidly obese patients post~     bariatric surgery.~   "
195640|NCT01002586|"~     Alzheimer's Dementia (AD) contributes to poor balance, impaired gait and functional status,~     thereby, increasing the risk of falls. AD is an independent risk factor for hip fractures.~     Those with balance problems and gait impairments are at higher risk for long term placement~     and death related to falls. Gait impairments in those with dementia include shortened step~     length, increased double support time, step to step variability, and decreased gait speed.~     These gait impairments worsen with dual tasking probably due to common brain areas involved~     in gait and other cognitive tasks.~      Exercise interventions improve gait and balance in the elderly. In subjects with existing AD,~     physical activity has shown to prevent further cognitive decline and improve quality of life~     and prevent falls. However, it is difficult to engage patients with AD in long term exercise~     programs. The expense of physical therapy limits its easy accessibility. Use of everyday~     technology might bridge this gap by providing high level of engagement via the use of~     multimedia while providing a cost effective alternative. Wii Fit is one such multimedia~     platform.~      Wii fit is a Nintendo gaming console used for aerobics, strength training and balance~     activities. This device includes a balance board that senses weight and shifts in movement~     and balance. Virtual trainers talk the user through the activity while tracking the user's~     progress.~      Although some skilled nursing facilities have started using Wii game system adjunct to~     routine physical therapy, there have not been any studies. Anecdotal reports note improvement~     in balance and social benefits using the Wii Fit program. Physical therapists report the~     ability to customize Wii for each patient. Wii Fit can be successfully used in a cognitively~     impaired population. A unique feature of this approach is the enjoyment and enthusiasm that~     many patients derive which is reflected in high levels of engagement.~      The invesitgators propose an 8 week prospective randomized study with the treatment group~     receiving the exercise program delivered by Wii-Fit system and the comparison arm receiving a~     walking exercise program in a community dwelling setting. Subjects in each arm will~     participate for 30 minutes daily five days a week.~   "
195641|NCT01002573|"~     The primary objective of the study is to determine the superiority of a single dose of~     intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first~     two hours of treatment.~   "
195642|NCT01002560|"~     The purpose of this project is to analyze tumour tissue from a group of subjects with~     malignant melanoma, who have been treated at the Royal Marsden Hospital.~   "
195662|NCT01002300|"~     Investigations into the components of cognition damaged in frontotemporal dementia (FTD)~     demonstrate that patients with FTD show deficits in facial and verbal expression recognition,~     lack insight into what others think or might do (theory of mind skills), and in decision~     making tasks requiring processing of positive versus negative feedback. These cognitive~     functions are thought to be critical for appropriate social behavioural regulation (Blair,~     2003). Recent studies in animal models and humans suggest that the neuropeptide oxytocin is~     an important mediator of social behavior and that oxytocin may facilitate emotion~     recognition, theory of mind processing, and prosocial behaviors (Donaldson and Young, 2008).~     Together, these findings suggest that upregulation of oxytocin dependent mechanisms of social~     and emotional cognition may be a valuable treatment approach in patients with FTD. The aim of~     this study is to determine how administration of intranasal oxytocin to patients with~     frontotemporal dementia affects behavior and processing of specific types of social and~     emotional information.The investigators' hypothesis is that oxytocin administration will~     improve emotional and social cognitive deficits in patients with FTD, resulting in improved~     decision making and behaviour.~   "
195643|NCT01002547|"~     Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition frequently associated~     with type 2 diabetes (T2DM) and characterized by insulin resistance and hepatic fat~     accumulation. Liver fat may range from simple steatosis to severe steatohepatitis with~     necroinflammation and variable degrees of fibrosis (nonalcoholic steatohepatitis or NASH). Up~     to 40% of patients with NAFLD develop NASH in recent series. Risk factors for progression to~     NASH are unclear, but appears to be more common and progress more rapidly in older~     individuals, and in the presence of obesity and T2DM. Because the VA population in San~     Antonio, Texas, frequently combine these risk factors for NASH it was felt that a study~     targeting this very high-risk population was needed.~      This study will establish the long-term efficacy (primary endpoint: liver histology) and~     safety of pioglitazone for the treatment of VA patients with T2DM and NASH. All patients~     diagnosed with NASH will be offered lifestyle modification/weight loss (current standard of~     care) while being randomized to pioglitazone, vitamin E or placebo for up to 3 years. We~     believe that in such a high-risk population for complications from NASH, a substantial~     benefit may be expected from early detection and treatment.~      Specifically, the arms are: a) pioglitazone + vitamin E; b) vitamin E + placebo of~     pioglitazone; c) placebo of both. Patients are randomized to one of these 3 arms, and~     followed in a double-blind fashion for up to 18 months. Patients are then offered to continue~     into an open-label phase with pioglitazone + vitamin E or vitamin E alone for another 18~     months.~   "
195644|NCT01002534|"~     The purpose of this study is to investigate the effect of a nasal instillation of Vardenafil~     on nasal potential difference in cystic fibrosis patients homozygous for the F508del mutation~   "
195645|NCT01002521|"~     This observational study aims to identify risk factors and molecular mechanisms of impaired~     wound healing, to guide better foot care in the diabetic population.~   "
195646|NCT01002508|"~     The safety and efficacy of vaccination against influenza in patients with scleroderma is not~     clear. The objective of this study is to assess its safety and efficacy in 50 patients with~     scleroderma in comparison with 30 controls~   "
195647|NCT01002495|"~     The purpose of this study is to evaluate the safety and tolerability of catheter based~     injections of VM202 into the heart.~   "
195648|NCT01002482|"~     The aim of the study is to determine whether the use of the CGAOtm software is associated~     with a decrease in 90-day mortality when compared with the use of standard care methods for~     glucose control with target blood glucose levels inferior to 180 mg/dl. The CGAOtm software~     is designed to assist physicians and nurses in achieving tight glucose control (defined by a~     target for blood glucose levels between 80 and 110 mg/dl) in critically ill patients.~   "
195649|NCT01002469|"~     In this short-term study a method for the evaluation of the metabolic competency of the urea~     cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for~     patients with urea cycle disorders and to monitor the severity of the disease, a reliable and~     safe quantitative method for the measurement of the urea cycle flux is required.~      Urea synthesis will be evaluated by administering sodium [1-13C]-acetate and measuring~     subsequent incorporation of [13C] label from Na-acetate into urea in healthy volunteers and~     asymptomatic subjects genetically disposed to urea cycle disorders.~   "
195650|NCT01002456|"~     The overall objective of the proposed pilot study is to begin evaluation of two methods for~     promoting adherence to guidelines for beta-blocker therapy in heart failure. The design~     includes site level baseline measurement, feedback, remeasurement after six months, and~     randomized (by site) comparison samples. The setting is VA sites, with intervention directed~     at the pharmacy.~   "
195651|NCT01002443|"~     Helicobacter pylori (H. pylori) is associated with gastric cancer in epidemiological~     studies.Gastric atrophy and intestinal metaplasia caused by H. pylori are considered as~     precancerous lesions, but whether H. pylori eradication improves these lesions is~     controversial.The primary objective of this study is to evaluate whether Helicobacter pylori~     eradication improves glandular atrophy and intestinal metaplasia which are known to be~     precancerous condition in patients undergoing subtotal gastrectomy for gastric cancer.~   "
195652|NCT01002430|"~     The purpose of the study is to evaluate the safety and efficacy of catheter mediated~     endocardial adenovirus VEGF-D gene therapy in patients with severe coronary heart disease.~   "
195653|NCT01002417|"~     The hypothesis of the study is to examine whether MCS-2 is safe and effective in the~     treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.~   "
195654|NCT01002404|"~     The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP~     with the angled tipped guide wire or the straight tipped guide wire.~   "
195655|NCT01002391|"~     This study was designed to determine whether the duration of dressing wear following~     reduction mammaplasty influence skin colonization and surgical site infections rates.~   "
195656|NCT01002378|"~     An open label, three way crossover study to determine the effect of a high fat breakfast or a~     low fat breakfast on the pharmacokinetics of a single dose of regorafenib.~   "
195657|NCT01002365|"~     Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized~     prospective study.~   "
195658|NCT01002352|"~     The primary purpose of the Bariatric Outcomes Longitudinal Database (BOLD) study is to assess~     the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship~     between these outcomes and 1) patient demographics and comorbidities, 2) clinical and~     surgical characteristics, and 3) pre-operative, peri-operative and post-operative care and~     treatment.~   "
195659|NCT01002339|"~     New onset diabetes after renal transplantation (NODAT) is a common and severe complication~     negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the~     basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection~     and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to~     CsA.~   "
195660|NCT01002326|"~     The purpose of this study is to develop and test the effectiveness of Cognitive-Behavioral~     Therapy (CBT) for children and adolescents suffering from Body Dysmorphic Disorder.~   "
195661|NCT01002313|"~     The primary objective of this study is to see whether systemic corticosteroids (such as~     Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with~     CRS. Patients are taking prednisone as part of their routine medical care.~   "
195665|NCT01002261|"~     The elimination of the carbohydrate galactose is used in daily clinical work with liver~     patients as a quantitative measure of metabolic liver function, as the liver test The~     Galactose Elimination Capacity, GEC. We are working to develop a PET/CT scanning procedure~     for providing 3D images of the hepatic galactose elimination and measurement of regional~     values. This may be used for example for planning resection or stereotactic radiotherapy of a~     patient with malignant tumor in the liver. Will the patient be able to tolerate removal of~     the necessary part of the liver? We will include 10 patients with liver cirrhosis and 6~     healthy human subjects. Direct measurements of the hepatic galactose elimination (successive~     constant iv infusions of galactose in increasing doses with measurements of blood~     concentrations of galactose in blood from an artery and a liver vein, and measurements of~     liver blood flow by indocyanine green, Ficks principle) are compared with PET/CT measurements~     after iv injection of a 18F-labelled galactose analog, FDGal.~      Based on previous studies in pigs, we perform detailed calculations of the hepatic galactose~     elimination kinetics by the two methods, including estimation of a factor (lumped constant)~     for recalculating PET/CT data to data for natural galactose.~      Besides possible practical clinical importance, the project elucidates basic problems~     concerning liver metabolism using PET.~   "
195666|NCT01002248|"~     This is a randomized Phase III study to evaluate the efficacy and safety of perifosine when~     added to the combination of bortezomib and dexamethasone in multiple myeloma patients who~     have relapsed on a prior bortezomib treatment regimen.~   "
195667|NCT01002235|"~     The purpose of this study is to assess the safety and tolerability of injecting VM202 in the~     leg muscle in patients with painful diabetic neuropathy (DPN). The study will also assess the~     potential of VM202 to reduce the pain associated with DPN.~   "
195668|NCT01002222|"~     This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who~     have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be~     eligible for this study.~   "
195669|NCT01002209|"~     This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is~     effective in reducing healing time and wound complications after lower extremity bypass~     surgery in patients with diabetes.~      Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients~     with diabetes undergoing peripheral vascular surgery~   "
195670|NCT01002196|"~     Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in~     central situations despite ability to talk. SM may cause great suffering and create problems,~     both socially and related to learning. SM is associated with social anxiety,~     neurodevelopmental delay and bilingualism. The prevalence is about .7-8 ‰. Adequate~     assessment and treatment of SM is seldom provided in the mental health services. SM is~     considered hard to treat, and randomised treatment studies are lacking. This study will~     examine the effect of a manual based treatment for SM. The treatment consists of home- and~     kindergarten /school based interventions including behaviour techniques and psychoeducation.~     Defocused communication is a general treatment principle. Comorbidity, including~     neurodevelopmental delay /disorder, and predictors of outcome, will be examined. A pilot~     study was conducted to ensure the feasibility of the planned effectiveness study. Seven~     children, aged 3-5 years were included. Six has started treatment, and all talked in the~     kinder garden within the first 3 months. The present study will have a randomised controlled~     design with 1. Manual based intervention for 6 months compared to 2. Waiting list controls (3~     months), and then manual based intervention. The sample: Children aged 3-9 years~     consecutively referred to the school psychology- or the mental health services in Oslo and~     Eastern Norway. Expected N = 24 based on the pilot study, is a sufficient sample size to~     answer our primary research question. The treatment will be given by a therapist from the~     research group or by a local clinician under supervision. The study can add essential~     knowledge on treatment of SM and make effective treatment available to clinicians in the~     community.~   "
195671|NCT01002183|"~     The aim of this study is to evaluate the role of clindamycin and artesunate as possible~     combination partners for fosmidomycin to protect it from its susceptibility to recrudescent~     infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining~     its excellent safety profile~   "
195672|NCT01002170|"~     In all treatments of tuberculosis, the second-line drugs are usually less effective but have~     more drug toxicity than the first-line ones. For the multidrug-resistant tuberculosis~     (MDR-TB) patients, who are resistant to the major first-line anti-tuberculosis drugs such as~     Rifampin and Isoniazid, the second-line agents, like Cycloserine in this research, are in~     frequent use. Taking patients' safety into consideration, therapeutic drug monitoring of~     Cycloserine has been listed as a routine examination during the tuberculosis treatment and~     established a suggested Cycloserine serum concentration of 20~35 mcg/mL.~      While this suggested drug concentration was set up, it isn't suitable to all races in the~     world. The investigators plan to develop the therapeutic drug monitoring protocols and a~     suggested treating concentration fitting for Asian (Taiwanese). In addition, through this~     research, the investigators can also realize that factors causing different pharmacokinetics~     and the clinical outcomes in different Cycloserine level.~   "
195673|NCT01002157|"~     Both Coronary Artery Calcification (CAC)and its annual progression are a strong predictors of~     cardiovascular events. The development of arterial calcification results from imbalance~     between calcification promoting and inhibiting factors. An important inhibitor of~     calcification is Matrix Gla Protein (MGP): a protein present in the vascular wall where it is~     synthesized by Vascular Smooth Muscle Cells (VSMC). MGP requires Vitamin K-mediated~     carboxylation to function properly. Deficiency of Vitamin K has been demonstrated to cause~     arterial calcification and a diet containing large amounts of Vitamin K2 was associated with~     lower CAC and cardiovascular risk. In animal studies, active supplementation of Vitamin K2~     caused regression of existing arterial calcification. Therefore, the aim of this randomized,~     double-blind, placebo-controlled clinical trial is to investigate whether daily~     supplementation of Vitamin K2 (Menaquinone-7) to patients with established CAC will lead to a~     decreased progression-rate of CAC after 24 months of follow-up in comparison to placebo.~   "
195674|NCT01002144|"~     Background: Increased serum high sensitivity C-reactive protein (hs-CRP) has been associated~     with airway inflammation in asthma and may serve as a surrogate marker for the presence of~     airway hyper-responsiveness (AHR) in this set-up. This study was designed to evaluate the~     predictive value of hs-CRP for AHR assessed by metacholine challenge test (MCT), in adults~     with suspected Asthma.~   "
195676|NCT01002118|"~     Cardiovascular disease and mortality is the largest comorbidity within the dialysis~     population. Nearly 50% of hemodialysis patients will have congestive heart failure at~     initiation. According to the most recent United States Renal Data System (USRDS), 40% of~     incident dialysis patients will have a cardiovascular event or die within the first 9 months~     of dialysis. It has been postulated that Omega-3 fatty acids could provide beneficial~     cardioprotection in hemodialysis patients. The investigators propose to evaluate Omega-3~     fatty acid doses on cardiovascular parameters in an incident hemodialysis population.~     Initially, this will be a pilot study. Ultimately, the information will be used to adequately~     plan for a larger intervention trial using Omega-3 fatty acids in incident hemodialysis~     patients.~   "
195677|NCT01002105|"~     This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent~     patients.~   "
195678|NCT01002092|"~     Purpose: This study will assess the safety and efficacy of Endostar combined with~     chemotherapy in osteosarcoma patients.~   "
195679|NCT01002079|"~     The purpose of the study is to determine if the concomitant administration of rifampin with~     BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and~     tolerability of co-administration BMS-708163 and rifampin~   "
195680|NCT01002066|"~     The purpose of this study is to study the effectiveness of wide scale RDT use at the primary~     health care level in previously high malaria endemic area during malaria pre-elimination~     phase for improved targeting of anti-malarial drugs, malaria surveillance and epidemic~     alertness.~   "
195681|NCT01002053|"~     The use of regional anesthesia for nerve block in diabetic patients with peripheral~     neuropathy is currently made on a case-by-case basis, also remains underlying uncertainty~     regarding the preferred technique and the likelihood of block-related nerve injury. For this~     many diabetic patients with otherwise healthy nerves may receive general anesthesia instead~     of regional anesthesia, thus giving up the benefits associated with the latter technique,~     including a decrease in health complications and superior analgesia following the operation.~     Ultrasound is used to identify the target nerve and guide needle insertion for nerve blocks,~     may be a useful tool to detect the presence and severity of neuropathy prior to block~     placement, a recent study demonstrated a statistically significant increase in the~     sonographic cross-sectional area of the posterior tibial nerve (PTN) in all diabetic patients~     who had abnormal motor transmission on nerve conduction studies. For regional~     anesthesiologists, the ultimate goal of detecting peripheral neuropathy and in particular,~     diabetic neuropathy by US is to avoid nerve injury. To do so, the association between~     US-detected diabetic neuropathy and block-related nerve damage must be first established,~     hence the purpose of this study. We aim to examine whether the cross-sectional area of PTN as~     assessed by preoperative US can predict nerve injury as assessed by worsening nerve~     conduction studies following PTN block inpatients scheduled to receive an ankle block. A~     further subgroup analysis will be performed in diabetic patients.~      We hypothesize that the cross sectional area of the PTN will correlate with motor conduction~     velocity on nerve conduction studies (NCS) following PTN block in patients with peripheral~     neuropathy. All eligible patients will undergo NCS to confirm or exclude distal neuropathy.~     Patients without neuropathy will be excluded from further participation in this study. Also~     excluded will be diabetic patients with neuropathy caused by genetic, metabolic and~     inflammatory diseases as well as toxic agents and drug induced. A systematic US examination~     of the PTN will be performed for all patients. After Block administration at surgery day the~     block successes will be assessed and for the purposes of the present study, patients in whom~     the block was not successful will be excluded from further intervention and data analyses.~     Eight weeks after surgery, all study patients will return to hospital for repeat NCS and US.~   "
195682|NCT01002040|"~     The purpose of this study is to assess the safety and effectiveness (immune response) to a~     licensed H1N12009 influenza vaccine in HIV-infected adults. The study will enroll 150 adults~     (ages 20-59 years). Participants will be randomized into 2 groups and will receive either one~     dose or two doses of a licensed H1N1 vaccine. Study procedures include: medical history,~     blood samples and completing a memory aid. Participants will be involved in study related~     procedures for approximately 6 days.~   "
195683|NCT01002027|"~     The study evaluates three best-practice care pathways for postnatal depression (PND) by~     comparing sole General Practitioner (GP) management to GP management in combination with~     CBT-based counselling from either a Psychologist or a Maternal and Child Health Nurse (MCHN).~   "
195684|NCT01002014|"~     The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and~     complications after skin sparing mastectomy with preservation of the nipple areolar complex.~     These outcomes will be observed in patients with both known cancer diagnosis and in those~     with indications for prophylactic mastectomy. The cosmetic appearance and complications will~     be followed through several post operative visits throughout the duration of the study. This~     study is conducted in conjunction with the plastic and reconstructive surgeons who will be~     performing the breast reconstruction procedures. Patient satisfaction will be measured via~     survey format. In addition, local recurrence rates will be compared to patients undergoing~     traditional mastectomy.~   "
195685|NCT01002001|"~     Sleep disturbance and sexual dysfunction are common complaints of patients with cirrhosis .~     The term sleep disturbance describes insomnia, poor quality sleep, circadian rhythm disorders~     and obstructive sleep apnea and is associated with reduced health-related quality of life~     (HRQoL) score indices. Sleep and sexual disorders have only been formally evaluated in small~     studies in these patients and to date, no studies have objectively assessed these patients.~     In addition, no studies have been performed in these patients after liver transplantation.~     The investigators' hypothesis is that sleep and sexual disturbance is commonly seen in~     patients with advanced cirrhosis and improves after liver transplantation. However, despite~     this, HRQoL remain impaired because of residual sleep disturbance.This study will be unique~     in providing cross-sectional follow-up of patients with cirrhosis at baseline and after liver~     transplantation (> 6 months).~   "
195686|NCT01001988|"~     This is a long-term follow-up of the persistence of immune response in participants who~     previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02~     (NCT00735644) . No vaccination was administered during the present long-term follow-up study.~      Primary Objective:~        -  To describe the yearly persistence of humoral immune response to Japanese encephalitis~          after a single dose of JE-CV~   "
195687|NCT01001975|"~     Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor~     (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with~     and without ensulizole.~   "
195688|NCT01001962|"~     Objectives:~      Primary~      1. Primary prevention of new onset of hypertension~      Secondary~        1. Reduction of 24h BP in type II diabetics with prehypertension~        2. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects~          receiving EMPAGLIFLOZIN~        3. Reduction in the total cardiovascular risk~        4. 3 years morbidity and mortality rates~        5. Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving~          EMPAGLIFLOZIN~   "
195689|NCT01001949|"~     The investigational product used in this study is a soft drink containing an~     arabinoxylan-oligosaccharide (AXOS) preparation extracted from wheat bran (hereafter called~     Wheat Bran Extract, WBE).~      The objective of this study is to analyze the effect of the intake of WBE on various~     parameters of gastrointestinal health in children (8-12 yrs). Additionally, safety was~     analyzed using treatment emergent Adverse Events (AEs).~   "
195690|NCT01001936|"~     The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100,~     200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant~     solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This~     study will also obtain preliminary information on the pharmacokinetics and antitumor activity~     of orally administered SKI-606 in subjects with advanced malignant solid tumors~   "
195691|NCT01001923|"~     Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain~     associated with chronic pancreatitis.~      Secondary objectives were:~        -  to assess the safety and tolerability of REGN475/SAR164877 in patients with chronic~          pancreatitis pain;~        -  to characterize the pharmacokinetic, pharmacodynamic, and immunogenicity profiles of~          REGN475/SAR164877 in this population;~        -  to measure the change in the total daily dose of rescue medications required.~   "
195692|NCT01001910|"~     This phase II trial studies how well pemetrexed disodium and carboplatin work in treating~     patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Drugs used in~     chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~   "
195693|NCT01001897|"~     The purpose of this study is to evaluate if the use of misoprostol can make it easier for a~     provider, and less painful for a woman, to place an IUD if she has never had a child before.~   "
195694|NCT01001884|"~     Aim:~      To examine the effects of the caregiver psychoeducational consultation program in reducing~     caregiver burdens, depression, sleep quality, and improving the experience in close~     relationship, positive meaning of illness and quality of life.~      This is the 2-year study. The design adopts the randomized controlled trial (RCT). The~     caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will~     be randomly assigned into two groups: one group receiving usual care, another group receiving~     the caregiver psychoeducational consultation program (CPCP). The usual care includes~     providing education materials only. Measurement time-points include pre intervention, post~     intervention, & then 1, and 3 months after the end of intervention for the maintenance~     effect.~   "
195695|NCT01001871|"~     Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient~     deficiencies on a worldwide basis, especially in developing countries. The impact of severe~     IDA can have mortal consequences, since without adequate hemoglobin, the brain and body~     become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown~     that iron supplementation in infants and young children can enhance child development,~     however, it may also result in increased rates of malaria in high burden areas.~      The primary objective of this study is to determine the impact of providing encapsulated iron~     (as a powder added to complementary foods) on the susceptibility to clinical malaria among~     anemic and non-anemic infants and young children (6-24 months of age) living in a high~     malaria burden area.~      The value of performing this research in Ghana is primarily that malaria and anemia remain~     the most important causes of death and morbidity.~   "
195696|NCT01001858|"~     The aim of the investigators study was to evaluate the effectiveness of a home programme~     (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated~     with CPAP and to analyze the cost of this approach.~   "
195697|NCT01001845|"~     For end-stage renal disease (ESRD) patients, cardiovascular disease remains the single most~     common cause of excess morbidity and mortality. Among the examined nontraditional risk~     factors, an increase in oxidative stress as well as inflammation are postulated to contribute~     to excessive cardiovascular risk in this population.~      Flavonoids are naturally occurring substances that possess various pharmacological actions~     and therapeutic applications. Some due to their phenolic structures have antioxidant effect~     and inhibit free radical-mediated processes, as well as anti-inflammatory effects.~     Silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (Silybum~     marianum) seeds, and is proven to have anti-oxidant, anti-inflammatory, cell regenerating,~     and antifibrotic action.~      In this study, the effect of silymarin on oxidative stress and inflammation (2 major risk~     factors for cardiovascular morbidity and mortality in hemodialysis patients)is evaluated, and~     compared to vit E, a well known antioxidant.~   "
195698|NCT01001832|"~     The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and~     immunogenicity of abatacept after subcutaneous and intravenous administration in Japanese~     participants with active rheumatoid arthritis and inadequate response to methotrexate.~   "
195699|NCT01001819|"~     Analysis of differential gene expression in patients with chronic rhinosinusitis without~     polyps compared to unaffected patients. Correlation of abnormal gene expression with surgical~     outcomes.~   "
195700|NCT01001806|"~     Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will~     be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects~     will be instructed to begin dosing the study medication in the operative eye the day before~     surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop~     of study medication will be instilled by operating room staff approximately every 15 minutes~     for a total of 3 doses. At the designated time a paracentesis will be performed at the start~     of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample~     will be immediately stored on dry ice and shipped to a laboratory for analysis.~   "
195701|NCT01001793|"~     The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory~     support in heart failure patients. The purpose of this clinical study is to determine its~     safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with~     presumed non-reversible left ventricular failure.~   "
195713|NCT01001637|"~     Curcumin is shown to impact several different pathways of neuroprotection, however clinical~     trials have not shown positive results, due to the poor bioavailability of curcumin. This~     study is designed to determine efficacy and safety of high-bioavailability curcumin~     formulation (Longvida) in subjects with Alzheimer's disease.~   "
195702|NCT01001780|"~     Chronic graft-versus-host disease (GvHD) is a severe, life threatening complication from~     getting a bone marrow or stem cell transplant. It is caused by certain cells from the donor~     that attack your cells. The usual treatments, prednisone and cyclosporine, don't work very~     well in chronic GVHD.~      This research is being done to determine if the combination of the chemotherapeutic and~     immunosuppressive, drugs pentostatin, cyclophosphamide and the monoclonal antibody rituximab,~     used as in the PCR combination will prove useful in the treatment of certain patients with~     chronic GvHD (namely those who are unlikely to respond to standard therapy).~   "
195703|NCT01001767|"~     Several studies have shown that there is an increased risk of heart disease in people with~     HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid)~     on improving endothelial function and decreasing inflammation which may contribute to this~     increased risk. The investigators will also be doing studies to analyze coagulation and~     inflammation markers.~   "
195704|NCT01001754|"~     Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral~     infections. The purpose of this study is to evaluate the safety and antiviral effects of~     several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in~     combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis~     C infection who have received no prior treatment for this disease.~   "
195705|NCT01001741|"~     While medication adherence is critical to successful treatment of HIV, there are few studies~     of interventions demonstrating improvements in adherence. This may be a particular challenge~     in the developing world, which has a larger burden of HIV but fewer resources than~     industrialized countries. The investigators propose a randomized controlled trial of cellular~     phone text message reminders to improve medication adherence. Our pilot study will be set in~     a large HIV clinic in Gaborone, Botswana, where Penn researchers have collaborated on~     research projects in the past. The primary study outcome will be antiretroviral medication~     adherence.~   "
195706|NCT01001728|"~     A randomised, two-arm, non-blinded crossover study investigating the impact of treatment~     position (prone versus supine) upon reproducibility of tumour bed position in patients~     undergoing breast radiotherapy following excision of early breast cancer.~   "
195707|NCT01001715|"~     Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain~     associated with vertebral fracture.~      Secondary objectives were:~        -  to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral~          fracture pain;~        -  to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in~          this population.~   "
195708|NCT01001702|"~     The purpose of this study is to test the long-term safety and tolerability of oral~     aripiprazole in adolescent patients with schizophrenia.~   "
195709|NCT01001689|"~     Fit for Delivery is a randomized, controlled study to examine the effects of an~     intervention during pregnancy which consists of exercise groups and nutritional counselling.~     We intend to study 600 women who are expecting their first child, and include them in our~     study at the time of their first appointment at their local healthcare clinic, when they are~     between 12 and 20 weeks of pregnancy. All women who wish to participate will sign an informed~     consent.~      Women who are randomly assigned to the intervention group will receive two telephone~     consultations with nutritional advice on healthy eating during pregnancy. They will also be~     counselled about appropriate weight gain during pregnancy given their pre-pregnancy body mass~     index. They will be assigned to an exercise group which will meet twice a week for a~     specially designed workout, and will be encouraged to exercise once or twice weekly on their~     own. Women in the intervention group will also have access to a password-protected internet~     site with information on healthy living during pregnancy, and be invited to 2 or 3 evening~     classes with nutritional information. Women who are randomly assigned to the control group~     will receive routine pregnancy care.~      All women in the study will be studied using:~        -  questionaires~        -  two ultrasound examinations (at 30 and 36 weeks of pregnancy),~        -  blood tests, including a 2 hour glucose challenge test, and measurement of hormones~          which regulate blood glucose levels~        -  weighing of the participant, including use of a bioimpedance scale~        -  weighing and measuring of her newborn baby,~        -  blood tests from the umbilical cord, measuring hormones which regulate blood glucose~          levels~        -  review of hospital records regarding mode of delivery, delivery complications and~          possible neonatal admissions for the newborn child.~      Our hypothesis is that an intervention in the form of nutritional information and exercise~     groups will:~        1. Affect the amount of weight women gain in pregnancy, and the amount of weight they~          retain 12 month after delivery~        2. Affect the percentage of newborns who have a birthweight over 4 kilo, or who have a~          birthweight at or above the 90th percentile for Norwegian newborns.~        3. Affect the blood sugar level and the incidence of gestational diabetes.~        4. Affect the incidence of operative deliveries and the delivery by Cesarean section.~        5. Affect the serum concentrations of hormones regulating blood sugar levels, measured in~          both participants and their newborns.~   "
195710|NCT01001676|"~     Introduction: Narrowing of the draining vein occurs in >50% of hemodialysis fistula and left~     untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in~     the vessel wall (intimal hyperplasia). The standard treatment is balloon dilatation. However,~     narrowing will inevitably recur in 2-3 months hence requiring further dilatation. Intimal~     hyperplasia also occurs in the heart and leg circulation. The drug paclitaxel has been used~     with great success in preventing intimal hyperplasia in these vessels following balloon~     dilatation. Administer locally, paclitaxel inhibits excess tissue growth in the vessel wall.~     The investigators believe that this drug will have similar effect in hemodialysis access..~      Objective: To assess the effect of paclitaxel in hemodialysis access with narrowing.~     Paclitaxel is delivered by a paclitaxel-coated balloon. This balloon dilates the narrow~     segment and simultaneously delivers paclitaxel to the vessel wall.~      Methodology: Patients with narrowed hemodialysis access are dilated with the~     paclitaxel-coated balloon or conventional balloon in randomized manner. The patency of the~     two groups are evaluated and compared at 6 months follow-up.~      Potential benefit: Decrease number of balloon dilatations and hence hospital admissions,~     improve dialysis fistula function, and decrease overall economic cost.~   "
195711|NCT01001663|"~     Is the FemoSeal® closure device safer and more comfortable than manual compression for~     femoral artery access closure after coronary angiography?~   "
195712|NCT01001650|"~     The purpose of this study is to determine the safety and tolerability of a non-replicating,~     metabolically active Plasmodium falciparum sporozoite (PfSPZ) vaccine in malaria-naïve~     healthy volunteers following multiple-dose subcutaneous (SC) or intradermal (ID)~     administration.~      In addition, the investigators wish to evaluate PfSPZ vaccine-mediated protection against P.~     falciparum challenge in the following 4 groups (see below) and compare protective efficacy of~     the PfSPZ vaccine when given by SC v ID administration in all these groups:~        -  Group 1: 4 doses of 7,500 PfSPZ/immunization,~        -  Group 2: 4 doses of 30,000 PfSPZ/immunization,~        -  Group 3: 4 doses of 135,000 PfSPZ/immunization~        -  Group 4: 4 or 6 doses of 135,000 PfSPZ/immunization.~      If > 80% protective efficacy is not achieved in Groups 1, 2, or 3, volunteers in Group 4 will~     receive a fifth and sixth dose.~   "
195728|NCT01001442|"~     This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define~     the best dose in treating patients with relapsed or refractory multiple myeloma with multiple~     doses of BT062.~   "
195714|NCT01001624|"~     The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment~     of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The~     control group will receive treatment with Hydroquinone (2%). The estimated number of subjects~     to be recruited and randomized for the study is 150. The primary outcome measure: Melasma~     Area and Severity Index (MASI) score will be assessed at the beginning of the study and at~     weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and~     54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will~     also be assessed.~   "
195715|NCT01001611|"~     The purpose of this study is to evaluate and confirm hypoglycemic efficacy and safety of~     CKD-501 as mono therapy in patients with type 2 diabetes treated once daily for 24 weeks in~     comparison to placebo.~   "
195716|NCT01001598|"~     Fanconi anemia (FA) and Dyskeratosis congenita (DC) are inherited bone marrow failure~     syndromes. The current androgen treatments (e.g., oxymetholone) used to treat FA and DC can~     cause unwanted masculinizing side effects, indicating a need for a different medication.~     Danazol is a less potent androgen,and may therefore have fewer masculinizing side effects.~     Danazol is currently approved by the Food and Drug Administration (FDA) for the treatment of~     other diseases, but it has never been studied in patients with FA and DC.~      The main purpose of this study is to see if danazol is a safe treatment for FA and DC.~     Specifically,we would like to determine:~        -  the best dose of danazol;~        -  how fast hemoglobin (a protein that carries oxygen in the blood) levels rise in FA and~          DC patients receiving danazol therapy; and~        -  the genetic pattern (known as expression profile) of certain cells in response to~          danazol, which can predict how well people respond to the medication.~      Subjects who enroll in the study will be treated with danazol for up to 24 weeks (about 6~     months), and will have up to 11 study visits, including followup visits at 38 weeks (9~     months) and 52 weeks (one year).~   "
195717|NCT01001585|"~     Summary. At the present, the investigators do not have the perfect anesthetic for~     mitochondrial patients. When possible, consideration should be given to the use of local~     anesthetics in small amounts. When a general anesthetic is necessary, they each carry~     significant risks and have been associated with poor outcomes. At present it is not possible~     to eliminate one group as less safe than others. What is clear is that these patients must be~     monitored more closely than other patients. The advent of the bispectral index (BIS) monitor~     may allow us to monitor their depth of anesthesia more closely and thus expose these patients~     only to the minimum amount of drug necessary to carry out the surgical procedure.~      Purpose. The investigators hypothesize that specific mitochondrial diseases, in particular~     those that decrease complex I function, make certain children hypersensitive to volatile~     anesthetics. These same patients may be at increased risk for adverse outcomes following~     general anesthesia. The specific aims of this application are:~        1. Determine which molecular defects in mitochondrial function lead to alter sensitivity to~          the VA sevoflurane.~        2. Establish the relative safety of sevoflurane in treatment of patients with mitochondrial~          disease.~      The investigators plan to monitor patients with mitochondrial disease using expanded measures~     of cardiovascular stability and measurements of brain electrical activity while slowly~     inducing general anesthesia. The investigators will use those measurements to limit the~     amount of anesthetic these patients receive in an attempt to minimize their risk. In~     addition, the investigators will correlate their sensitivity to the type of mitochondrial~     defect so that the investigators may be able to predict which patients are likely to have an~     increased sensitivity.~   "
195718|NCT01001572|"~     This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill~     combination in patients with uncomplicated essential hypertension not adequately controlled~     (MSDBP ≥90 mmHg and <110 mmHg) on valsartan 160 mg alone.~   "
195719|NCT01001559|"~     This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with~     an antidepressant is better than an antidepressant alone in adults with major depression.~   "
195720|NCT01001546|"~     The overarching aim of the study is to evaluate in a randomized trial the impact of an~     internet intervention compared to a standard clinic-based control group to promote smoking~     cessation among Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) veterans.~   "
195721|NCT01001533|"~     The aim of the study is to investigate the use of a new FDA-approved non-invasive~     bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in~     children undergoing radiology procedures. The purpose of the study is to determine the~     ability of the ICON monitor to identify the anticipated and documented hemodynamic changes in~     children which occur in response to Dexmedetomidine sedation. The investigators postulate~     that if the ICON device can trend hemodynamic changes, if any, during dexmedetomidine (DEX)~     sedation in children the investigators can delineate changes in cardiac output, stroke~     volume, and systemic vascular resistance associated with observed changes in heart rate and~     blood pressure.~   "
195722|NCT01001520|"~     This study will test the hypothesis that a medication called tolcapone (Brand Name: Tasmar)~     will help reduce cognitive problems that smokers experience when they quit. This study will~     also determine whether the benefits of this medication differ depending on a smokers' genetic~     background.~   "
195723|NCT01001507|"~     This is a cluster randomized trial comparing the integration of family planning services into~     HIV care and treatment programs versus the standard referral for family planning services~     outside of HIV care and treatment programs within Suba, Kisumu East, Rongo and Migori~     districts in Nyanza province.~   "
195724|NCT01001494|"~     The main purpose of this study is to assess the long term bronchodilator efficacy, safety and~     tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD~     patients and the benefits of the product in disease-related health status, COPD symptoms and~     COPD exacerbations.~   "
195725|NCT01001481|"~     The primary objective of this treatment review and feedback program is to quantify the risk~     status for medication adherence in a cohort of Australian patients diagnosed with~     schizophrenia.~   "
195726|NCT01001468|"~     The purpose of this study is to examine the efficacy, safety and tolerability of VB-201 as~     compared with placebo on measures of disease activity in patients with psoriasis.~   "
195727|NCT01001455|"~     The purpose of this study is to monitor the blood pressure level of the patient using a~     preformed cuff ranged 22 cm-36 cm.~   "
195731|NCT01001390|"~     This study is designed to see if children with acute lymphoblastic leukemia who have~     developed foot drop during treatment for their leukemia consume less oxygen when walking with~     or without an ankle brace designed to support their foot during walking. In this study~     children with foot drop are asked to walk for six minutes with and without brace on their~     ankle. During each walk, the amount of oxygen used is measured. The child wears a face mask~     which is attached to a device that records how much oxygen they use. The amount of oxygen~     used during the walk with the brace on will be compared to the amount of oxygen used with the~     brace off.~   "
195732|NCT01001377|"~     The primary objective of this study is to compare the effect of panitumumab versus cetuximab~     on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among~     patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.~   "
195733|NCT01001364|"~     This study primary objective is to compare the impact of two products containing budesonide~     and formoterol as individual capsules with inhalation powder for the pulmonary function of~     subjects with persistent asthma.~   "
195734|NCT01001351|"~     PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting~     dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to~     improve primary patency and long-term survival of AVGs and thereby provide patients with~     chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis.~     Recent data indicate that up to three quarters of patients have loss of graft patency at one~     year, indicating a substantial need for new therapies. This clinical trial will explore the~     safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly~     placed upper extremity AVG.~   "
195735|NCT01001338|"~     To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL~     following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to~     allopurinol alone in subjects with documented inadequate hypouricemic response with standard~     doses of allopurinol.~   "
195736|NCT01001325|"~     Since the onset of the 2009 pandemic, several observational public health investigations in~     Canada have identified evidence that suggests that adults, particularly younger adults, who~     have previously received seasonal influenza vaccine are at increased risk of infection with~     the 2009 pandemic strain of H1N1 (pH1N1). Investigations in Australia, the United States and~     the United Kingdom have not identified this effect. While it is not possible to have an~     answer to whether this affect is real prior to the second wave of the 2009 pandemic, it~     remains vital to future influenza vaccination programs that the hypothesis that, in 2009,~     seasonal vaccine increases or decreases the risk of pH1N1 infection be confirmed or refuted.~      The objective of this study is to determine whether Ontario adults aged 18-60 years who~     receive the 2009 seasonal influenza vaccine will be at a 2 fold or greater increased risk of~     infection with influenza pH1N1 during the second or third wave of the 2009 pandemic.~   "
195737|NCT01001312|"~     Heart failure is a common cardiac condition affecting nearly 6 million Americans. Silent~     blood volume overload is common in patients with heart failure and is associated with~     increased risk of death. This study is designed to determine if adjustment of therapy based~     on direct measurement of blood volume will reduce risk of hospitalization and death when~     compared with therapy based on clinical assessment of blood volume in patients with chronic~     heart failure.~   "
195738|NCT01001299|"~     This open-label single-arm study will evaluate the effect of RO5185426 [RG7204; PLEXXIKON:~     PLX4032] on the pharmacokinetics of five CYP450 substrates (caffeine, warfarin + vitamin K,~     omeprazole, dextromethorphan, midazolam) administered as a drug cocktail to patients with~     metastatic melanoma. The study will also evaluate efficacy and safety of RO5185426. On day 1,~     patients will receive the drug cocktail. On days 6 to 19, patients will receive RO5185426~     twice daily. On day 20, patients will receive RO5185426 and the drug cocktail and on days 21~     to 25, patients will receive RO5185426. Assessments will be made at regular intervals during~     the dosing periods and at follow-up. Patients may continue on study treatment (RO5185426)~     until the development of progressive disease or unacceptable toxicity. Target sample size~     <50.~   "
195739|NCT01001286|"~     This randomized controlled trial (RCT) evaluates the effectiveness of Questscope Non-Formal~     Education (QS NFE) on impacting psychosocial outcomes for out-of-school youth, ages 13-21, in~     Jordan. QS NFE is an empowerment-based education program. A unique agreement with the~     Jordanian Ministry of Education enables participating youth to receive a 10th-grade~     equivalent certificate upon successful completion of the 24-month non-formal education. The~     main components of QS NFE include retraining formal education teachers for fostering positive~     relationships with at-risk youth, asset-building learning and social activities, and a~     youth-driven learning environment.~      The study hypothesis is that by engaging youth in positive relationships with local teachers~     and enabling the youth to drive the learning experience, the intervention will have positive~     impacts on general self-efficacy, social supports, social skills, and strengths and~     difficulties.~   "
195740|NCT01001273|"~     This study proposes a simple and safe way of lowering this complicate rate, while improving~     graft recovering and protecting the graft as it recovers from the transplant. The~     investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin~     clamp during surgery and 72 hours post-operatively the investigators will be able to lower~     the complication rate by 50%.~   "
195741|NCT01001260|"~     To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty~     (PTCA) procedure.~   "
195755|NCT01001078|"~     This study will compare two supraglottic airway devices currently on the market. Supraglottic~     airway devices are used during general anesthesia to provide a patent airway. They are~     inserted blindly into the mouth once the patient has lost consciousness and they cover the~     laryngeal inlet. The I-Gel and the Supreme laryngeal mask airway (LMA) are the two devices to~     be compared. The I-Gel has no inflatable cuff, which makes it different from all other~     supraglottic airway devices currently in use. The Supreme shares some characteristics of the~     other LMA devices, but it is disposable. Our main goal will be to compare the airway leak~     pressure and the peak airway pressure of each devices. We will also measure the time needed~     for insertion, number of attempts needed to secure the airway and side effects related to the~     airway (cough, dysphagia, trauma, hoarseness of voice, sore throat).~   "
195756|NCT01001065|"~     Cross sectional observational ultrasound study of transplanted kidneys and the carotid artery~     in consecutive recruited outpatients.~   "
195742|NCT01001247|"~     The purpose of this study is to investigate the extent by which intake of 20 mg once daily~     (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d..~     This study also investigates - in case levels of TMC278 are reduced when co-administered with~     omeprazole - whether a double dose of TMC278 (50 mg q.d.) or a separation of intake of both~     drugs by 12 hours may circumvent a decrease of TMC278 levels in the blood below the clinical~     effective concentration. Omeprazole is prescribed to reduce the production of gastric acid.~     Since TMC278 requires gastric acid to be properly dissolved and taken up in the blood~     circulation, intake of omeprazole has an influence on the levels of TMC278 in the blood~     circulation. This effect has been revealed in a previously conducted clinical trial, using~     the combination of 150 mg TMC278 q.d. and 20 mg q.d. omeprazole. The currently proposed study~     will also further explore the relationship between the levels of TMC278 in the blood at~     several time points and the acidity of the stomach. Also the short-term safety and~     tolerability of co-administration of omeprazole 20 mg q.d. and TMC278 25 mg q.d. will be~     assessed.~   "
195743|NCT01001234|"~     This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment~     of Migraine in Children and Adolescents.~   "
195744|NCT01001221|"~     Primary Objectives:~        -  Study part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting~          Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination with~          gemcitabine, every 3 weeks in patients with advanced solid malignancies.~        -  Study part 2: To determine the antitumor activity of cabazitaxel in combination with~          gemcitabine, in an additional extended cohort of 15 patients with advanced solid~          malignancies treated with the defined MTD, as assessed by objective response rate (ORR)~          according to the revised guideline for Response Evaluation Criteria in Solid Tumours~          (RECIST 1.1 criteria).~      Secondary Objectives:~        -  To assess the safety profile of the combination regimen of cabazitaxel with gemcitabine.~        -  To assess the pharmacokinetics (PK) of cabazitaxel, gemcitabine and its metabolite 2',2'~          difluorodeoxyuridine (dFdU) when given in combination.~        -  To determine Time to Progression (TTP), Objective Response Rate (ORR), and Duration of~          Response (DR), in the extended cohort of patients treated at the MTD in Part 2 of the~          study and the patients who received the MTD in Part 1 component.~      For study part 1, dose levels were to be escalated according to predefined dose escalation~     decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at~     least 2 patients developed a DLT during the first 3 weeks of treatment. There was no further~     dose escalation when this dose was achieved. The MTD was defined as the highest dose at which~     0 or 1 of 3 to 6 patients, respectively, experienced DLT during the first 3 weeks of~     treatment.~   "
195745|NCT01001208|"~     The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept~     compared with etanercept monotherapy as measured by the percentage of participants achieving~     a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week~     24.~   "
195746|NCT01001195|"~     This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study~     will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).~   "
195747|NCT01001182|"~     Rheumatoid Arthritis (RA) is a chronic debilitating disease, causing severe pain and~     progressive joint destruction and leading to partial loss of mobility. The disease has a~     severe impact on patients' quality of life, due to the pain and physical impairment it~     causes, which can also result in psychological and social difficulties. Moreover, the chronic~     nature of the disease deems necessary the long-term use of medication, causing significant~     costs to the patient and the healthcare system. The decline in functional ability can cause~     problems at work, with reduced productivity or even unemployment. In addition, RA can limit~     the patients' ability for self-care, hence imposing a further burden on the patients'~     families and the society.~      Many international studies have confirmed the reduced quality of life for people suffering~     from RA [1-3], as well as the large economic impact of the disease on the patients, the~     health system and society [4-6]. However, no assessment of the above impact of RA on the~     Greek population has been published so far.~      A wide research of the literature confirms the relationship between costs and quality of life~     on the one hand and functional ability (as measured by the Health Assessment Questionnaire)~     on the other hand. [7-8] The impact of functional ability on quality of life is~     straightforward, however studies also demonstrate that as disease symptoms progress, without~     proper treatment, the overall costs undertaken by the patient or the healthcare system can~     rise significantly. On the other hand, if effective treatment can lessen or postpone the most~     serious consequences of the disease (such as extensive joint damage that could lead to~     surgical replacement), the savings on healthcare can offset some of the costs of the more~     effective drug therapies.~      In the light of the above findings, it seems important that in order to properly assess~     therapeutic strategies for RA patients it is necessary to have an accurate view of the total~     burden of RA on the population. It is also important to be able to establish a robust~     relationship between functional ability and impact of RA on costs and quality of life.~   "
195748|NCT01001169|"~     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     investigational influenza vaccine GSK2340274A following one dose and following a second dose,~     using the same dosage as has been used in the H5N1 development program in Japanese children~     aged 10-17 years and an alternative dose in children aged 6 months to 9 years.~   "
195749|NCT01001156|"~     The purpose of this study was to use associated breathing exercises the incentive inspiratory~     of load lineal pressoric, Threshold® IMT, or of load pressoric alinear, Voldyne®, in~     institutionalized elderly, comparing the effect of the same ones in the training of the~     breathing musculature, for the increment of the muscular strength, expressed by the maximum~     breathing pressures (MIP and MEP).~      From the total number of admitted people (n = 52), 12 individuals were excluded: one by~     appearance of cognitive deficit, one by death (stroke), one by visual deficit (glaucoma) and~     twelve by failure to continue the training. After selecting the sample, the 37 participants~     were randomly divided into three different groups: the Threshold Group (TG; n = 13, age = 70.~     93 ± 8.41 years old, BMI = 24.06 ± 3.69 kg/m²), the Voldyne Group (VG; n = 12, age = 70.54 ±~     7. 73 years-old, BMI = 27.17 ± 5.66 kg/m²) and the Control Group (CG; n= 12, age = 73. 92 ±~     7.28 years-old, BMI = 24.80 ± 5.42 kg/m²). The TG and VG received treatment with respiratory~     exercises and Threshold and Voldyne muscular training, respectively. The CG received only~     respiratory exercises.~   "
195750|NCT01001143|"~     The main objective is to determine the safety and tolerability of combination decitabine and~     bexarotene during four cycles of therapy.~   "
195751|NCT01001130|"~     Non-interventional, open-label, single group, multicentric post-marketing surveillance to~     monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients~     according to the prescribing information.~      AVAMYS is a registered trademark of the GSK group of companies.~   "
195752|NCT01001117|"~     The use of a femtosecond laser in cataract surgery that gives equivalent or improved results~     comapred to conventional phaco-emulsification surgery.~   "
195757|NCT01001052|"~     The purpose of this study is to evaluate and compare the relative bioavailability of a single~     dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects~     18-30 years of age compared to a group of older, generally healthy subjects 60 years of age~     or older following an overnight fast.~   "
195758|NCT01001039|"~     This study proposes to develop and validate a new instrument designed to measure facial and~     nasal discomfort related to chronic sinusitis. The second phase of the study will be to use~     this instrument to measure correlation with sinus computed tomography (CT) scans.~   "
195759|NCT01001026|"~     The purpose of this study is to assess the safety and effectiveness (immune response) to a~     licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll~     200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will~     receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed~     H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood~     samples and completing a memory aid. Participants will be involved in study related~     procedures for approximately 3 weeks (adults) or 6 weeks (children).~   "
195760|NCT01001013|"~     The objective of the study is to investigate the drug interaction between LC15-0444 and~     pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and~     pioglitazone are administered concomitantly and each alone in healthy male subjects.~   "
195761|NCT01001000|"~     Prospective observational ultrasound study of native arterio-venous fistula for haemodialysis~     with venous pressure measurement using controlled compression ultrasound.~   "
195762|NCT01000987|"~     The purpose of this study is the examine the effect of varenicline on cognition to a high~     dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of~     the blood alcohol curve.~   "
195763|NCT01000974|"~     The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the~     vaccine, to address the relevant concomitant vaccine administrations and to provide a~     comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib~     vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and~     15-18 months of age. This study is designed with a primary and a booster phase.~   "
195764|NCT01000961|"~     Cystinosis is an inherited disease that if untreated, results in kidney failure as early as~     the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate)~     which must be taken every six hours for the rest of the patient's life to prevent~     complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being~     studied to see if it may be able to be given less frequently, once every 12 hours, and have~     similar results to four times a day Cystagon®.~   "
195765|NCT01000948|"~     This is a prospective, open, one-arm, two-centre, Phase II clinical safety pilot-study. The~     trial is designed to gain initial safety and efficacy-related data on once-daily orally~     administered ZD4054 10 mg in prior chemotherapy treated patients with metastatic~     hormone-resistant prostate cancer.~   "
195766|NCT01000935|"~     Partial-thickness and full-thickness rotator cuff tears are common soft-tissue conditions~     that often require surgical treatment. Initial efforts to improve tendon healing centered on~     improving the strength of the repair construct. More recent studies have focused on biologic~     enhancement of the healing process. The use of platelet concentrates to improve healing, has~     been explored considerably during the last decade. Platelet Rich Plasma (PRP) is a fraction~     of plasma that has been isolated and used to enhance regeneration in bone and soft tissues.~      There is information on use of PRP in oral surgery, achilles tendon healing, limb lengthening~     procedures, chronic elbow tendinosis, ruptures/degenerative changes in the patellar tendon,~     and osteoarthritis of the knee. There are no randomized clinical trials to our knowledge that~     have examined the impact of PRP in patients with rotator cuff tear.~      The objective of the proposed pilot study is to examine the effectiveness of autologous~     Platelet Rich Plasma (PRP) application in promoting healing of the rotator cuff (RC) tendons~     following arthroscopic rotator cuff repair through a randomized controlled study.~   "
195767|NCT01000922|"~     Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal~     injections of individual doses of the study insulins.~   "
195768|NCT01000909|"~     Part I:~      Proof of concept trial to achieve normal venous pressure values under different provocation~     maneuvers in healthy persons~      Part II:~      Non invasive measurement of venous pressure under different provocation maneuvers in patients~     with chronic venous disease~   "
195769|NCT01000896|"~     The primary purpose of this study is to explore the safety and tolerability of AZD0530 in~     combination with carboplatin and paclitaxel in Japanese patients with non small cell lung~     cancer and epithelial ovarian cancer.~   "
195770|NCT01000883|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This research study is looking at tissue and blood samples from women with locally~     advanced or metastatic breast cancer~   "
195771|NCT01000870|"~     The purpose of the study is to evaluate the efficacy and safety of MNI-513 positron emission~     tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with~     Alzheimer's disease compared to healthy volunteers.~   "
195772|NCT01000857|"~     The primary purpose of this study is to compare the steady-state pharmacokinetic profile of~     paroxetine CR (controlled-release) at the dosage of 25mg/day using the proposed final market~     tablet of CR 25mg in Japan with that of standard paroxetine IR(immediate-release ) at the~     dosage of 20mg/day using the currently marketed tablet of IR 20mg in Japan.~   "
195785|NCT01000688|"~     Rationale: Cardiovascular complications in type 2 diabetes are the leading cause of morbidity~     and mortality associated with the disease. Endothelial dysfunction is regarded as an~     important factor in these vascular complications.~      The introduction of glucagon-like peptide-1 (GLP-1) analogues and dipeptidyl peptidase IV~     (DPP-IV) inhibitors for the treatment of type 2 diabetes is of special interest because of~     possible influences on endothelial function. Numerous reports have shown that GLP-1 improves~     endothelial function.~      Objective: To determine whether a four week treatment with vildagliptin compared to acarbose~     improves endothelial dysfunction in patients with type 2 diabetes mellitus.~   "
195773|NCT01000844|"~     The original Joint Outcome Study (JOS) enrolled 65 boys with hemophilia from 16 sites~     nationally. The subjects were randomized to one of two arms (prophylaxis or an enhanced~     episode-based treatment)and were followed prospectively until the age of six. At the age of~     six, the proportion of children on each treatment arm who developed bone or cartilage damage~     as determined by X-Ray or MRI was assessed. In addition, the function and structure of the~     index joints (defined as knees, ankles, and elbows)were evaluated using a physical assessment~     scale specially designed for preschool children.~      The specific aim of the Joint Outcome Study Continuation (JOSC) is to extend observations of~     the children participating in the original JOS until the subjects reach the age of 18 years~     in order to determine the natural history of joint development in hemophilia and the impact~     of primary or secondary prophylaxis on the prevention, limitation, or reversal of hemophilic~     arthropathy. In addition, plasma and DNA will be collected and banked yearly for current and~     future studies of biomarkers and predictors of hemophilia outcomes.~   "
195774|NCT01000831|"~     The purpose of this study is to compare the safety and effectiveness (immune response) to one~     or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an~     additive that can boost the immune response. The study will enroll 300 children (ages 6-35~     months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 3 weeks apart.~     Study procedures include: medical history, blood samples and completing a memory aid.~     Participants will be involved in study related procedures for approximately 6 weeks.~   "
195775|NCT01000818|"~     An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on~     MK0518 as part of a stable treatment regimen for HIV.~   "
195776|NCT01000805|"~     The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for~     8 weeks to patients diagnosed with major depressive disorder, who also report associated~     painful physical symptoms, is better than placebo when treating depression and its associated~     painful symptoms.~   "
195777|NCT01000792|"~     The prevalence of allergic rhinitis is high and appears to be rising worldwide. Therefore, it~     is important and necessary to understand and visualize therapy effects on this disease. In~     this study we will demonstrate the effect of levocetirizine on nasal cavity dimensions by~     assessing not only standard nasal flow diagnostics such as rhinomanometry and acoustic~     rhinometry, but supplement exami¬nation procedures with long-term rhinometry and magnetic~     resonance imaging (MRI). With the aid of a virtual model and computer fluid dynamics, we are~     able to simulate nasal air flow and provide three-dimensional visualization of the computed~     flow.~      In previous trials ([Bachert], [deBlic], [Day] and [Deruaz]) it has been shown that allergic~     symptoms, especially nasal congestion, diminish significantly under treatment with~     levocetirizine. We will demonstrate this anti-obstructive effect by comparing the reaction to~     nasal allergen challenge before and after four-week treatment with levocetirizine.~   "
195778|NCT01000779|"~     Background: Variceal bleeding is a major cause of morbidity and mortality in patients with~     Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation~     (EVL) have been used to prevent rebleeding in these patients, largely based on data from~     cirrhotic patients. Endotherapy in the form of EST has been well studied in preventing~     rebleed in patients with NCPH. Initial studies showed that EST significantly reduced the~     rebleeding rate in patients of NCPH. Data from these studies suggests a rebleed rate of~     approximately 25% at 2yr and 35% at 5 years.~      Beta blockers have been found to be quite effective in both primary as well as secondary~     prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. In contrast~     to liver cirrhosis, published data on the effect of beta blocker therapy on NCPH are scanty.~     Animal data and human data suggests that beta blockers reduce portal pressure in patients~     with NCPH. In two placebo controlled trials of propranolol on secondary prophylaxis of~     variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of~     propranolol in decreasing rebleed rate. However, no comparisons hae been made with EVL till~     date.~      Hypothesis: The investigators hypothesis that In patients with NCPH, treatment with beta~     blockers will lead to reduction in portal pressure and decrease in portosystemic shunting~     leading to reduction in variceal rebleeding Aim of the study: Aim: To compare the efficacy~     and safety of Propranolol and EVL in the prevention of variceal rebleeding in patients with~     NCPH.~   "
195779|NCT01000766|"~     The purpose of this study is to try to develop new blood tests that may help doctors identify~     if a drug is hurting a person's liver.~   "
195780|NCT01000753|"~     RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the~     laboratory may help the study of cancer in the future.~      PURPOSE: This research study is collecting and storing tissue samples from patients with rare~     or cutaneous non-Hodgkin lymphoma.~   "
195781|NCT01000740|"~     The primary objective is to describe the quality of life of long-term survivors who are not~     terminated from the EAP.~   "
195782|NCT01000727|"~     This study will test whether darapladib can safely lower the chances of having a~     cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g.~     medical procedures performed to restore the normal blood flow in patients with~     atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome~     (also called ACS).~   "
195783|NCT01000714|"~     Psoriasis is a chronic disorder characterized by erythematous scaly patches which affect the~     scalp, trunk, extensor surfaces of the limbs and the genital area. The common form of~     psoriasis is referred to as psoriasis vulgaris. There are several variants of psoriasis such~     as guttate psoriasis, inverse psoriasis, pustular psoriasis and erythrodermic psoriasis.~      Psoriasis is highly prevalent in the general population, mainly as a result of its chronicity~     and the absence of a cure. The estimates of psoriasis prevalence are within the range of 0.5%~     to 4%.~      The diagnosis of psoriasis is made on a clinical base, usually by physical examination,~     performed by a dermatologist. Although skin biopsy may be useful in some cases, there is no~     laboratory test which may serve as a reference standard to the clinical diagnosis of~     psoriasis.~      Psoriasis in its mild cases per se is not associated with excess mortality, however, the~     disease may affect quality of life of affected patients to a substantial degree. Psoriasis~     may be readily apparent to others because of scales and redness of the skin. The skin may~     itch and scales may shed from the patients to the environment or directly on other people.~     Feelings of stigmatization and major changes in life-style caused by psoriasis have been~     documented in numerous studies. The burden of the disease may be exaggerated due to expensive~     therapy and complicated therapeutic regimes Patients with mild to moderate psoriasis are~     usually treated with topical treatments. Photo-therapy or systemic treatments are reserved to~     patients with moderate to severe disease.~      Topical corticosteroids may lead to rapid improvement in psoriasis, however rapid relapse~     following discontinuation is the common practice leading to chronic use.~      Calcipotriene ointment may also be used and requires 8 to 12 weeks of use for maximal effect~     and often causes local irritation, particularly when used on the face. The use is limited to~     100 gr/week due to hypercalcemia that might follow systemic absorption.~      Vitamin A derivative tazarotene may be also be used for plaque psoriasis. Although it can~     produce longer remissions than topical steroids, local irritation, cost, and teratogenicity~     limit its use.~      Coal tar products may be used as steroid-sparing agents, especially useful for enhancing the~     efficacy of natural sunlight and phototherapy. Application can be cumbersome because of~     irritation, unpleasant smell, brown color that can stain clothing, and propensity to cause~     folliculitis.~      All of the above treatments are particularly problematic for the face and genital psoriasis~     due to the potential side effects and mainly possible severe irritation reducing patients~     compliance.~      Psirelax is a novel topical medication directed for the treatment of patients with psoriasis.~     The formulation of Psirelax includes the following substances: 5%-15% quince seeds jelly,~     10%-40% natural base cream (e.g. Ferntree Cottage Pure Base Cream), 55%-75% mixture of~     natural anti-oxidants (e.g. Vitamin E, wheat germ oil, Safflower oil), natural skin softening~     agents (e.g. sweet almond oil, sesame oil), natural absorption aids (e.g. jojoba oil,~     vegetable squalene), natural tissue regenerating and protecting agents (e.g. grape seed oil,~     sunflower oil), natural preservatives (e.g. paraben, tea trea essential oil, thyme essential~     oil, grapefruit seed extract, Vitamin E) and natural thickening agents (e.g. bee wax,~     aloevera, medicinal Vaseline, coconut oil, guar gum, palm oil, borax)~      In a preliminary observation, a patient with severe psoriasis applied Psirelax three times~     each day during four days. The patient reported complete disappearance of the psoriatic~     plaques and pruritus was reduced by 70%. It was suggested to conduct an open study to assess~     the effect of Psirelax in patients with psoriasis vulgaris.~      The aim of this study is to examine the safety and efficacy of Psirelax in the treatment of~     psoriasis.~   "
195784|NCT01000701|"~     Subproject 1: Optimize prevention after acute coronary syndromes (ACS) by improving caregiver~     and patient education (http://elips.hug-ge.ch/eng/index_eng2.htm)~      Subproject 2: Discover novel genomic biomarkers of ACS in leukocyte subsets by means of~     analyzing gene expression profiles and function~      Subproject 3: Evaluate novel diagnostic and prognostic biomarkers in soluble form in~     blood/plasma and urine~      Subproject 5: Visualize the vulnerable plaque using intravascular ultrasound/optical~     coherence tomography (IVUS/OCT) and correlate with outcome and biomarkers~      Subproject 7: Characterize the effects of inflammation on progenitor/stem cell-mediated~     repair after ACS by means of analyzing gene expression profiles and function~   "
195786|NCT01000675|"~     The current proposal describes a post-market, clinical registry of HydroSoft, aimed at~     gaining robust clinical data in a large set of patients to better define the advantages, and~     potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.~   "
195855|NCT00999765|"~     The purpose of this study is to evaluate the feasibility and short-term efficacy of MBCT as~     an add-on (i.e. patients must be stable with their regular mood stabilizing medication) for~     the maintenance therapy of bipolar disorder.~   "
195787|NCT01000662|"~     All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen~     of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly~     boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated~     as the daily boost during accelerated prone radiotherapy.~   "
195788|NCT01000649|"~     The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE~     202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood~     vessel) leakage. FE 202158 had previously been tested in healthy volunteers.~   "
195789|NCT01000636|"~     The aim of this study is to determine possible molecular changes on large scale gene~     expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic~     keratoses (AK) and cancerised field in renal transplant recipients.~   "
195790|NCT01000623|"~     Rationale: Venlafaxine may help relieve hot flashes in women who have had breast cancer.~     Hypnosis or focused attention may help control hot flashes in postmenopausal women. It is not~     yet known whether giving venlafaxine together with hypnosis or focused attention is more~     effective in treating hot flashes.~      Purpose: This randomized clinical trial is studying venlafaxine together with hypnosis or~     focused attention in treating patients with hot flashes.~   "
195791|NCT01000610|"~     In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in~     patients with active rheumatoid arthritis who have had an inadequate response to~     methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and~     background methotrexate (10-25mg po or sc weekly). After the initial study period of 24~     weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated~     time on study treatment is 1-2 years and target sample size is <50~   "
195792|NCT01000597|"~     Previous studies have shown potentially higher exposure to fluticasone furoate in Japanese~     subjects compared with Caucasian subjects. The reasons for these potential differences are~     unclear. Therefore this study is being done to look at and compare how fluticasone furoate is~     processed by the body in healthy Caucasian, Japanese, Korean and Chinese subjects after~     inhaled and intravenous administration. The data obtained will be used to help in the~     clinical development of the drug in Japanese and other East Asian populations.~   "
195793|NCT01000584|"~     The purpose of this study is to assess the safety and effectiveness (immune response) to a~     licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the~     seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants~     will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine~     and one dose of the seasonal influenza vaccine at the same time; the second group will~     receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009~     influenza vaccine. Study procedures include: medical history, blood samples and completing a~     memory aid. Participants will be involved in study related procedures for approximately 3-6~     weeks depending upon the group assignment.~   "
195794|NCT01000571|"~     This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin~     monovalent influenza vaccine in immunocompromised children and young adults.~   "
195795|NCT01000558|"~     RATIONALE: Collecting and storing samples of blood from patients with cancer to test in the~     laboratory may help the study of cancer in the future.~      PURPOSE: This research study is collecting and storing blood samples from patients with~     previously untreated non-Hodgkin lymphoma.~   "
195796|NCT01000545|"~     The purpose of this study is to determine the effect and safety of Sulodexide in Filipino~     patients with Chronic Kidney Disease (CKD).~   "
195797|NCT01000532|"~     This investigation is designed to demonstrate the clinical efficacy and safety of the~     low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical~     investigation.~   "
195798|NCT01000519|"~     Randomized study on the comparison between aerobic training versus progressive resistance~     training over a 2 months period for older adults with type 2 diabetes. The hypothesis is that~     progressive resistance training is just as effective as aerobic training on Hba1c and could~     be an alternative training for those older diabetic patients who cannot participate in~     aerobic exercise.~   "
195799|NCT01000506|"~     The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously~     (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma~     despite receiving high doses of standard asthma medications. The study will look at different~     doses of mepolizumab in comparison to a placebo.~   "
195800|NCT01000493|"~     This is a 12-week, randomized, multicenter, double-blind, placebo controlled, fixed-dose~     parallel group study to assess the efficacy and safety of orvepitant (60 mg/day) versus~     placebo in subjects with a diagnosis of noncombat-related Posttraumatic Stress Disorder~     (PTSD), whose symptoms are considered moderate or severe.~      Following an initial screening visit, subjects fulfilling the study inclusion and exclusion~     criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory~     and ECG assessments and to confirm eligibility for inclusion into the study. This screening~     phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the~     screening period, eligible subjects will be randomized at the baseline visit to receive~     either orvepitant 60mg/day or placebo (1:1 ratio). Those subjects randomized to receive~     placebo will receive study medication identical in appearance to that received by subjects~     assigned to receive orvepitant.~      Efficacy will be assessed using the Clinician Administered PTSD Scale (CAPS) as the primary~     efficacy measure. Key secondary efficacy endpoints will be based on the Davidson Trauma Scale~     (DTS), the Short PTSD Rating Interview (SPRINT), the Clinical Global Impression- Global~     Improvement and Severity of Illness Scales (CGI-I and CGI-S, respectively), the Hamilton~     Depression Rating Scale (HAM-D), the Cognitive and Physical Functioning Questionnaire (CPFQ)~     and the Pittsburgh Sleep Quality Index (PSQI).~      Safety will be assessed by monitoring for adverse events (side effects) and through periodic~     laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart~     rate, temperature) and heart function measurements (electrocardiograms, or ECGs).~   "
195801|NCT01000480|"~     This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in~     combination with radiotherapy in participants with locally advanced, non-small cell lung~     cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by~     progression free survival 1 year after start of treatment with study drug.~   "
195803|NCT01000441|"~     Approximately 30% of patients with rheumatoid arthritis have an inadequate response to~     anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second~     anti-TNF or change of biologic, with a different mechanism of action, such as abatacept,~     rituximab and tocilizumab. No controlled trial compared these two strategies face to face.~     The present objective is to investigate the issue whether one of these strategies could have~     a better efficacy in a pragmatic trial in the setting of current practice.~   "
195804|NCT01000428|"~     Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.~     Higher response rates were observed in a subset of patients with female gender, Asian~     ethnicity, no smoking history, mutations in EGFR tyrosine kinase, high EGFR gene copy number~     and adenocarcinoma histology. However, the therapeutic effect of Erlotinib is not confined to~     patients whose tumors harbor EGFR mutations and other predictors of efficacy of this agent.~     And these tests require time and sufficiently large specimens for processing, whereas many~     patients with advanced NSCLC are diagnosed based on cytology alone.~      This study was designed to evaluate FLT-PET or FDG-PET usefulness in the early assessment of~     treatment response and in predicting patient outcome after erlotinib monotherapy for patients~     with non-small cell lung cancer prospectively. Changes in tumor FLT or FDG uptake 7 days~     after the initiation of treatment will be compared between responders and nonresponders based~     on subsequent CT scans.~   "
195805|NCT01000415|"~     The purpose of this study is:~        -  to compare the effectiveness between the new strategy of treatment (given cis-platinum~          plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard treatment~          (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific~          group of cervical cancer patients (stage Ib2-early IIb)~        -  to evaluate quality of life in both group of patients(standard treatment vs.experimental~          group)~   "
195806|NCT01000402|"~     This is an outpatient program for children and adolescents with bipolar disorders. The~     naturalistic approach of the program will allow a proper investigation of the disorder,~     assessment of environmental and biological factors, the conduction of treatment studies, and~     follow-up of the subjects.~   "
195807|NCT01000389|"~     To investigate the effect of the treatment with Grindcare® on the parafunction of the~     muscles- and jaw activity (Bruxism) during sleep.~   "
195808|NCT01000376|"~     The purpose of this study is to investigate whether ketoconazole, taken orally, influences~     the level of eribulin in the blood when the two drugs are given at the same time. The study~     will enroll patients with solid tumors whose cancer became worse even after standard~     treatment, or for whom there is no standard treatment available. The study will also~     investigate whether eribulin given together with ketoconazole is safe (has few side-effects)~     and is effective against cancer.~   "
195809|NCT01000363|"~     This pilot study aims to increase access to diabetes education by delivering it in a~     culturally-appropriate community setting and by involving different members of the diabetes~     care team including physicians, diabetes educators, and health promoters/community health~     workers.~      Diabetes medical group visits will be held at the Grady North DeKalb satellite clinic the~     third Thursday of the month starting in October 2009. There will be two cohorts of patients-~     English speaking patients and Spanish speaking patients. Each group will be scheduled for 4~     2-hour group visits throughout a period of 9 months. These visits will be every 8 weeks for~     each group. During the visit, the patient will be seen by a physician, attend a diabetes~     education session, re-fill their diabetes medications and receive lab orders.~   "
195810|NCT01000350|"~     The investigators will test whether an intravenous infusion of saline (salt water) will~     improve the exercise capacity in patients with postural tachycardia syndrome (POTS).~   "
195811|NCT01000337|"~     Anesthesia may affect the function of vital organs. Liver is one of them. The investigator's~     hypothesis is that intravenous or inhalation anesthesia does not impair liver function as~     assessed by more elegant tests like markers indicating liver apoptosis. In the present~     randomized prospective trial female patients scheduled for mastectomy or thyroidectomy will~     receive inhalation or total intravenous anesthesia and markers for liver dysfunction will be~     determined.~   "
195812|NCT01000324|"~     This study will evaluate the persistence of the immune response to HAV (Hepatitis A Virus)~     antigens and HBs (Hepatitis B surface) antigens in healthy adults previously vaccinated with~     GlaxoSmithKline (GSK) Biologicals' Twinrix™ Adult. The subjects will be invited for blood~     sampling 16, 17, 18, 19 and 20 years after vaccination to evaluate the antibody persistence.~     For subjects in whom low circulating antibodies are detected, the presence of immune memory~     against hepatitis A & B antigens will be investigated by the administration of a challenge~     dose of the appropriate vaccine (Havrix™ and/or Engerix™-B) at the next planned visit.~      No new subjects will be recruited during this study.~   "
195813|NCT01000311|"~     This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and~     non-interference of concomitant routine vaccines by MenACWY in an infant age group.~   "
195814|NCT01000298|"~     The need for oral antibiotics as part of the case management of severe acute malnutrition~     (SAM) in the outpatient setting has not been studied in a prospective trial. This study will~     compare the recovery rates of children with SAM treated at home with locally-produced~     ready-to-use therapeutic food (RUTF) with and without prescribed antibiotics as part of their~     outpatient case management. The investigators hypothesize that there will be no significant~     difference in rates of recovery between children who receive and children who do not receive~     antibiotics.~   "
195815|NCT01000285|"~     The rationale of the current study is to explore the use of combination chemotherapy together~     with antiretroviral agents in order to determine the efficacy and toxicity of this approach,~     while also examining markers of virus replication and expression, and tumor cell~     proliferation to gain understanding of the biological basis of this malignancy and to~     identify predictors of response.~   "
195816|NCT01000272|"~     The purpose of this study is to determine whether inflammatory bowel disease in children~     involve the respiratory tract as expressed by increased levels of the Fraction of exhaled~     Nitric Oxide (FeNO) and spirometry.~   "
195817|NCT01000259|"~     This research study is looking at tumor tissue samples from patients who have undergone~     surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of~     tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor~     infiltrating T cells can predict how patients will respond to treatment.~   "
195818|NCT01000246|"~     Patients treated with chemotherapy or immunosuppressives are at higher risk of influenza~     infection and mortality and morbidity are higher compared to healthy adults. Vaccination~     against the influenza virus can prevent these complications. In this study it is investigated~     whether vaccination during chemotherapy is effective in reaching protective serum antibody~     concentrations and the relation between time of vaccination (day 4 +/- 1 day versus day 16~     +/- 1 day of the chemotherapy cycle).~   "
195819|NCT01000233|"~     Intervention study focused on preventing the progression of aortic valve calcification.~      Vascular and cardiac calcifications are a marker of risk and poor outcome, especially the~     severe calcified aortic stenosis and coronary calcification.~      Its increasing prevalence is now a health problem. The knowledge and the therapeutic~     objective of this condition have changed in recent years and pathophysiological aspects at~     present, focus on atherosclerotic disease and inflammation.~      Several clinical trials have failed to demonstrate that statins or ACE inhibitors prevent the~     progression of cardiovascular calcification.~      Taking into account the new concepts of ectopic calcification and research results from our~     group, the most logical approach to prevent progression would be an early intervention and~     management of the calcification inhibiting agents such as phytate (inositol six-phosphate --~     InsP6).~      Hypothesis: The phytate prevents or delays the progression of cardiovascular calcification.~      It is a clinical trial of intervention of oral phytate (InsP6) in patients with mild to~     moderate cardiovascular calcification (aortic valve and / or coronary arteries) compared with~     placebo over a period of 24 months.~      It is a prospective, randomized minimization of variables to ensure homogeneity of the~     groups.~      The primary analysis will be the time evolution of the extent of calcium in the aortic valve~     and coronary arteries made with CT.~      Secondary variables are the degree of progression of aortic stenosis and clinical events~     (death, stroke, angina, stroke and cancer of any type).~   "
195820|NCT01000220|"~     Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible~     inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions~     the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this~     Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need~     to take omeprazole due to GI problem are evaluated in two groups including placebo and drug~     users. The effect will be finally assessed.~   "
195821|NCT01000207|"~     This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule~     (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy~     children/adolescents based on European Medicines Agency's Committee for Medicinal Products~     for Human Use (EMEA/CHMP) criteria, and safety and tolerability.~   "
195822|NCT01000194|"~     The main objective of this study is to elucidate whether different dietary fatty acids (SFA,~     PUFA, butter fat and margarine fat) in a high fat load will have different effects on PBMC~     gene expression profiles. Secondary objectives are to elucidate the effects of these fat~     loads on individual plasma free fatty acid profiles, triglycerides and cholesterol levels.~   "
195823|NCT01000181|"~     The build up of plaque in the wall of the artery supplying blood to the brain poses a risk of~     stroke when the plaques become unstable and fragile. It is important to determine which~     patients are most at risk so that surgery can be performed. There is evidence that the risk~     is greatest when these plaques become oxygen deficient (hypoxic). The investigators wish to~     use PET imaging to identify hypoxic plaque, to help decide whether and when to perform~     surgery. The investigators have developed radiotracers (imaging agents) for this purpose, and~     this study is to determine whether they will work in patients.~   "
195824|NCT01000168|"~     Introduction.~        -  There is a demand for evidence whether treadmill therapy is more efficient than~          traditional walking training as an intervention for patients with hemiplegia after~          cerebral stroke.~      Design.~        -  A randomized controlled trial.~      Material.~        -  Stroke patients with moderate to severe functional deficits referred to inpatient~          medical rehabilitation.~      Method.~        -  Comparing a treatment group receiving treadmill training with body weight support with a~          treatment group receiving conventional walking training.~      Study aim:~        -  Investigate whether treadmill therapy is more effective than traditional functional~          training in restoring walking and transfer in patients with moderate to severe~          ambulatory deficits after stroke.~   "
195825|NCT01000155|"~     Sickle Cell Disease (SCD) is a hereditary anemia that causes the red blood cells to change~     their shape from a round and doughnut-like shape to a half-moon/crescent, or sickled shape.~     People who have SCD have a different type of hemoglobin (protein that carries oxygen). This~     different type of hemoglobin makes the red blood cells change into a crescent shape under~     certain conditions. Sickle-shaped cells are a problem because they often get stuck in the~     blood vessels blocking the flow of blood and can cause inflammation and injury to important~     areas of the body. All babies are born with hemoglobin called fetal hemoglobin (HbF). Soon~     after birth, HbF production slows down and another hemoglobin called adult hemoglobin (HbA)~     is made. Clinical studies have shown that increasing the amount of HbF in the blood may~     prevent sickling of the red blood cells. Vorinostat has been used in the treatment of cancers~     and in other research studies and information from those suggests that it may help treat SCD~     by increasing the amount of HbF in the blood. The purpose of this research study is to~     determine the effectiveness and safety of vorinostat when used to treat SCD.~   "
195826|NCT01000142|"~     This pilot research study will investigate the possible benefit that elderly nursing home~     patients may receive from regular Osteopathic Manipulative Medicine (OMM) care during the~     winter months. The study is based on the osteopathic philosophies that structure and function~     are interrelated and that the body has self-healing mechanisms. The body is expected to have~     optimized ability to heal itself when all its parts are in place (AT Still). This study is~     looking at subject population for whom their ability to take care of themselves is diminished~     by their underlying diseases. Based on the osteopathic philosophies, optimization of the~     nursing home patient's physical structure through osteopathic manipulative treatment (OMT)~     should enhance their body's homeostatic mechanisms. This study is assessing the validity of~     these philosophies by looking at the effect of OMT on the global health of these individuals.~   "
195827|NCT01000129|"~     To demonstrate that radiotherapy treatments for bladder cancer can be delivered with greater~     accuracy using a new planning method and that this method can be used simply and effectively~     by those delivering treatment.~   "
195828|NCT01000116|"~     In this study the researchers want to compare fibrin glue versus tacked fixation in fixation~     of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the~     first 3 days postoperative days. Moreover, the researchers investigate general well-being,~     fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are~     investigating chronic pain and clinical recurrence.~   "
195829|NCT01000103|"~     Visuospatial neglect is a common neurological symptom which appears following strokes on~     regions of the right hemisphere of the brain. It affects patient's self representation and~     awareness of the space, impairing functional rehabilitation and adaptation back to a normal~     life. The primary purpose of this protocol is to assess the impact of 10 daily sessions of a~     non-invasive brain stimulation technique, low frequency repetitive Transcranial Magnetic~     Stimulation (rTMS), applied on the intact hemisphere of the brain to treat post stroke~     visuospatial neglect at the chronic stage. The hypothesis is that a regime of real but not~     sham rTMS on the left posterior parietal cortex of the brain will long-lastingly ameliorate~     visuospatial neglect in stroke patients as revealed by clinical paper-and-pencil and~     computer-based tests assessing search, detection and discrimination of stimuli presented in~     different areas of the visual field.~   "
195830|NCT01000090|"~     Evaluate biochemical differences in acromegalic patients treated with surgery versus~     somatostatin analogues (SMS) (after surgery or alone).~      Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly.~   "
195831|NCT01000077|"~     The purpose of this study is to establish viable cell culture system techniques for a variety~     of healthy and diseased tissues for use in future in vitro and in vivo research studies in~     tissue engineering.~   "
195832|NCT01000064|"~     The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can~     help with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently~     approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this~     drug may have on attention deficits caused by TBI are not known, but we expect that Vyvanse~     will be of some help in treating those types of problems as well. The study will utilize~     functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to~     elucidate neural mechanisms of response.~   "
195833|NCT01000051|"~     The goal of this clinical research study is to learn if eltrombopag can help to improve~     platelet counts in patients with low platelets after they have had a stem cell transplant.~     The safety of this drug will also be studied.~   "
195834|NCT01000038|"~     Purpose of the study: Falls in Alzheimer's Disease (AD) are common and lead to fractures,~     acute hospitalizations and increased rate of institutionalization. Poor balance and gait~     abnormalities, commonly associated with AD, are risk factors for falls. Improving balance and~     gait abnormalities is critical to prevent falls in AD.~      Exercise interventions improve gait and balance in elderly. Walking is the most commonly~     recommended home-based exercise program for elderly by primary care providers. However, it is~     difficult to engage patients with AD in long term exercise programs. Barriers to exercise~     programs include lack of motivation, poor engagement, and external factors such as the cost~     of physical therapy (PT). Use of readily available technology might bridge this gap by~     providing high level of engagement via use of multimedia at an affordable price.~      Wii-Fit is a Nintendo gaming console used for aerobics, strength training, and balance~     activities. This device includes a balance board that senses weight, movement and balance.~     Wii-Fit is a TV based self-directed activity not limited by the constraint of a therapist's~     presence. Virtual trainers talk the user through the activity while tracking progress.~     Furthermore, visual and auditory feedback improves engagement. Some skilled nursing~     facilities have started using the Wii-Fit as an adjunct to PT, and note improvement in~     balance along with social benefits but no systematic studies are done to generalize the~     findings.~      The investigators propose an 8 week prospective randomized study with the treatment group~     receiving the exercise program delivered by Wii-Fit system and the comparison arm receiving a~     walking exercise program.~   "
195835|NCT01000025|"~     RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether PF-00299804 is more effective than a~     placebo in treating patients with advanced non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying PF-00299804 to see how well it works~     compared with a placebo in treating patients with stage IIIB or stage IV non-small cell lung~     cancer that has not responded to standard therapy for advanced or metastatic cancer.~   "
195836|NCT01000012|"~     To provide access of the Becker Expander/Breast implant to women who do not meet~     inclusion/exclusion criteria of the Becker Continued Access Study~      Patients' physician will contact Mentor to request use of the device and each request will be~     reviewed by Mentor, an IRB, and the FDA on a case-by-case basis~   "
195837|NCT00999999|"~     Main objective of this trial is to assess the hypothesis whether the application of TachoSil®~     as a dural sealant improves the quality of craniotomy procedure and outcome in general~     compared with standard dural closure techniques in a controlled and randomized way. As a~     primary endpoint the investigators look at possible postoperative occurrence of CSF pads or~     leakages needing any kind of intervention until day 30 after the primary craniotomy.~     Furthermore, the investigators will look at other surgery-related complications and at~     pharmacoeconomic endpoints such as hospital stay or cost of the implant. Overall, the results~     of this study will provide important information on whether or not the adjunct of a~     relatively expensive implant on a routinely basis for the closure of elective craniotomies is~     safe and effective, or not.~      To date, TachoSil® is often used in neurosurgery and other surgical disciplines in a~     non-standardized fashion also to prevent CSF leakage after dural closure. So far, adverse~     events directly related to the product have not been reported. Theoretically, any implant may~     be associated with a higher incidence of postoperative infections (e.g. epidural, subdural or~     subgaleal empyema). On the other hand, it is not known whether or not the application of~     TachoSil® on the dural suture may reduce CSF leakage.~   "
195853|NCT00999791|"~     Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.~      Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe~     dosage is identified that can be used in diffuse diabetic macular edema for treatment. in~     this study, we are going to compare the effect of intra vitreal injection of Diclofenac and~     Bevacizumab in primary treatment of diffuse diabetic macular edema.~   "
195838|NCT00999986|"~     Condylomata acuminata (CA) caused by human papillomavirus (HPV) is a common sexually~     transmitted disease with half a million new cases diagnosed in the United States per year.~     Recurrence is a major challenge for CA treatment. The investigators have demonstrated that~     FOXP3+ regulatory T (Treg) cells mediate the immunosuppression in large genital warts. And~     low-dose cyclophosphamide (CY), a conventional chemotherapy drug, has been reported to~     selectively deplete Treg cells in cancer patients. Therefore, the investigators hypothesized~     that low-dose CY can be used to treat genital warts. In this study, 104 CA patients have been~     recruited for clinical trial with a 1:2 randomization. Among them, 64 patients received~     low-dose cyclophosphamide and 32 received placebo. In 8 extra patients, high-dose~     cyclophosphamide was given.~   "
195839|NCT00999973|"~     In this study 126 eyes in 63 patients with moderate bilateral myopia and astigmatism between~     -3 and -5 (SE difference between two eyes should not be more than 0.75 and the residual~     corneal thickness>350 μ ) were entered in the study. One eye went randomly under PRK with~     mitomycin C 0.02% in 15 min and then the other eye went under the operation without MMC.~     UCVA,BCVA, refractory error after the operation and the number of endothelial cells before~     and after the surgery would be compared in 6 months.~   "
195840|NCT00999960|"~     To evaluate the clinical impact of an online video simulator during the learning period of~     laparoscopic radical prostatectomy.~   "
195841|NCT00999947|"~     The purpose of this trial is to study the genetic and phenotypic aspects of Arrhythmogenic~     Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C), and determine the impact of genetic~     testing in clinical practice.~   "
195842|NCT00999934|"~     The purpose of eye movements is to ensure clear, optimal vision. In order to see clearly,~     images must be held steady on the retina. Best visual acuity is achieved when the image of~     the object of interest is brought to and held on the fovea of the retina. Two main types of~     eye movements are responsible for that: those that keep images stable on the retina (gaze~     holding mechanisms) and those that change the line of sight (gaze shifting mechanisms).~     Several functional classes of eye movements have been defined; each has distinctive~     physiological properties that suit best to its particular task. Thus, vestibular and~     optokinetic eye movements hold images of the seen world steady on the retina during~     perturbations of the head. Saccades are rapid eye movements that bring the image of an object~     of interest, detected in the periphery of vision, onto the fovea where it can be seen best.~     Smooth pursuit eye movements place the images of a moving target close to fovea. Vergence eye~     movements place the images of a single object simultaneously onto both foveae.~      Each functional class of eye movements relies on a different neural substrate. The clinical~     significance of it is that impairment of a specific class of eye movement points to~     involvement of distinct structures or pathways within the brain. Thus, abnormalities of~     ocular motility are often the clue to the anatomical localization of neurological disorders.~      Significance: This study will contribute to understand how the brain governs production of~     eye movements, and provide better insight on interaction between sensory (visual) and motor~     (eye movement) system, i.e. sensory-motor interaction. It will also contribute to identify~     pathophysiological mechanisms underlying human diseases and will improve the investigators'~     ability to diagnose and encourage development of new therapeutic strategies.~      Methods: The investigators will measure eye and head movements using the magnetic scleral~     search coil technique. The magnetic search coil technique is the most sensitive and accurate~     technique used in modern ocular motor and vestibular research for measuring horizontal,~     vertical and torsional eye movements. The coils are easy to apply and well tolerated over a~     wearing period of up to 45 minutes per recording session.~      Population: A grand total of about 250 individuals (normal subjects and patients) will be~     recruited for the study. Patients will be recruited from the in- and out-patients of the~     Neurology and Neuro-ophthalmology services of Meir Medical Center. Healthy normal subjects~     will be recruited from faculty and staff of Meir Medical Center.~      Criteria for inclusion/exclusion: The investigators will study patients with neurological~     disorders causing abnormal eye movements: Degenerative CNS diseases, extrapyramidal~     disorders, Spino-cerebellar ataxias, Cerebrovascular diseases, demyelinating diseases, Ocular~     motor and vestibular palsies, Mitochondrial and other ocular myopathies. Only patients who~     are medically stable and are able to give informed consent will be included in the study.~     Criteria for excluding subjects will include eye disease such as corneal or scleral abrasion~     or disease, glaucoma, refractive errors greater than 2 diopters and concurrent medication~     with CNS-active agents.~   "
195843|NCT00999921|"~     The purpose of the study is to determine the efficacy and relapse rate of low dose, short~     duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with~     respect to etiology and estrogen receptor status and to realize its side-effects and cost of~     therapy.~      To do a comparative analysis of the results with evening primrose oil which is one of the~     first line management in benign breast disease.~   "
195844|NCT00999908|"~     This study compared the effects of a single dose of indacaterol with that of a single dose of~     tiotropium on inspiratory capacity.~   "
195845|NCT00999895|"~     The purpose of the study is to evaluate the outcome of treatment switch defined as an~     improvement in CGI-CB scale (Clinical Global Impression - Clinical Benefit).~   "
195846|NCT00999882|"~     The main purpose of the study is to establish a safe dose of AZD8055 in patients with mild or~     moderate liver disease by providing information on any potential side effects this drug may~     cause and collecting data about how hepatocellular carcinoma responds to the drug.~   "
195847|NCT00999869|"~     Alopecia areata is one of the most common cause of non-scarring alopecia. The pathogenesis is~     still unclear, however, it is believed to be an autoimmune disease. This disease is not a~     life-threatening condition but it has a significant psychological impact to patient's quality~     of life.~      Many triggers have been proposed such as viral infection, stress and neurologic factors.~     There are many studies show the correlation between disease activities and neurotransmitters~     level. Substance P and calcitonin gene-related peptide play major role in early stage of~     disease. These substances cause imbalance of CD4/CD8 lymphocyte in pathologic site and loss~     of immune privilege of hair follicles.~      The conventional treatment of alopecia areata with intralesional corticosteroid injection~     might treat the end of pathogenesis process.~      There is no therapeutic intervention for the origin of disease. Fortunately, botulinum toxin~     A could be a novel treatment of alopecia areata. The botulinum toxin A demonstrates~     inhibition release of substance P in many publications.~      To sum up, the treatment of alopecia areata with intralesional corticosteroid injection still~     be a standard treatment, nevertheless, patients have to receive this treatment every month~     until regrowth of scalp hair. Corticosteroid injection have several side effects, for~     example, skin atrophy, pigmentary change and hypothalamic-pituitary-adrenal axis suppression.~     Moreover, injection pain is also affect to psychological aspect .~      This study purpose is to evaluate the efficacy of botulinum toxin A for alopecia areata and~     reduce corticosteroid side effects, as well as, others opportunity cost. There is no~     prospective, randomized-controlled trial of comparison study between botulinum toxin A~     injection and corticosteroid injection for alopecia areata, therefore, investigators conduct~     this study for the greatest benefit to alopecia areata patients and for the future research~     in disease etiology.~   "
195848|NCT00999856|"~     The study is intended to evaluate a non-invasive method of glucose measurement in diabetics.~     The medical device that is evaluated consists on a sensor-insert which is placed under the~     conjunctiva of the eye of diabetic patients and a photometer. The goal is to prove that the~     sensor signal correlates with the blood glucose of the patients determined by standard~     laboratory blood glucose measurement.~   "
195849|NCT00999843|"~     Patients with liver cancer will receive interventional therapy plus radiotherapy. Maintenance~     Sorafenib will be taken after the completion of radiotherapy. Hypothesis of the current study~     is that Sorafenib as a maintenance therapy is safe and superior to radiotherapy combined with~     interventional therapy in terms of survival in comparison to historical data.~   "
195850|NCT00999830|"~     This is an open randomised phase II study evaluating the anti-tumour activity, safety and~     pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in~     patients with multiple myeloma in stable partial response after a first line therapy.~   "
195851|NCT00999817|"~     A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on~     dextromethorphan.~   "
195852|NCT00999804|"~     Breast cancer is the most common malignancy in the U.S. Targeted therapies such as tamoxifen~     have been revolutionary in reducing tumor recurrences and mortality in early breast cancer.~     Using this successful paradigm, there has been a continued search for other targeted biologic~     therapies directed at receptors with known potential for promoting tumor growth.~      The estrogen receptor (ER) and/or the HER signaling pathways are the dominant drivers of cell~     proliferation and survival in the majority of human breast cancers. Molecular targets of~     these pathways provide the most effective therapies in appropriately selected patients.~     However, de novo and acquired resistance remain major obstacles to successful treatment, and~     understanding the molecular pathways responsible for this resistance would enable the~     discovery of new strategies to overcome it.~      The superiority of multi-drug HER2-targeted therapy over single agent therapy has been~     demonstrated in the preclinical setting using mouse xenografts. Trastuzumab, pertuzumab,~     lapatinib, and gefitinib, represent a group of therapeutic agents that target the HER family~     by different molecular mechanisms. Used as single agents in the MCF7/HER2-18 xenograft model,~     these drugs restored or enhanced sensitivity to tamoxifen. However, tumor growth inhibition~     lasted only 2-3 months before resistance to treatments occurred. However, when gefitinib, a~     HER1 inhibitor, was added to the two-antibody (T+P) regimen to block signals from HER1~     dimers, a complete disappearance of nearly all xenograft tumors was observed; moreover, there~     was evidence of complete tumor eradication in 50% of the mice. The combination of lapatinib +~     trastuzumab was also highly effective in eradication of tumor burden, with no evidence of~     re-growth after 200 days. These xenograft models demonstrate that multi-drug HER2-targeted~     therapy more effectively induces apoptosis and inhibits proliferation, thereby resulting in~     tumor regression. Furthermore, HER2 combination therapy appears to more effectively reduce~     levels of phosphorylated pAKT and MAPK, thus resulting in sustained tumor inhibition.~   "
195854|NCT00999778|"~     This project will examine the efficacy of two different treatment approaches aimed at~     facilitating change in social and communications outcomes of toddlers with autism.~   "
195857|NCT00999739|"~     Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults~     with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under~     5logs), one with conjugated heptavalent vaccine(Prevenar, Wyeth-Lederle) followed by~     polysaccharide vaccine 4 weeks after (Aventis-Pasteur), and two with one dose of~     polysaccharide vaccine. Determination of secondary effects related to both vaccines and~     determination of antibody concentration (ELISA) and avidity (ELISA with thiocyanate) and~     opsonophagocytosis killing activity against the seven serotypes included in the heptavalent~     vaccine before vaccination, at 4 weeks, at 8 weeks, at48 weeks and 96 weeks. A sample of 220~     HIV-infected adults (110 in each group) will be needed to detect differences of 10% for a~     type I error o 5% for a limited population of 2500 HIV-infected adults. The main hypothesis~     are :the immunogenicity of pneumococcal vaccination with conjugate and polysaccharide~     vaccines is superior to immunogenicity induced by polysaccharide vaccination alone(antibody~     concentration), the avidity and opsonophagocytosis induced by two vaccines is better than the~     one after polysaccharide vaccine alone, both vaccinations are safe.~   "
195858|NCT00999713|"~     Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia~     and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these~     children represent a relatively small and unique patient population, they account for the~     largest proportion of deaths of all pediatric diseases. The long-term goal of this project is~     to improve outcomes among these patients. Recently, the intratracheal administration of~     calfactant has resulted in decreased mortality among children with ALI including promising~     results among children with cancer and following HSCT. Consequently, the primary specific aim~     of this study is to assess the effect of calfactant on intensive care (PICU) survival among~     pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment~     of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU~     stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung~     injury in the overall pediatric population by improving oxygenation and decreasing mortality.~     These findings, in conjunction with recent subgroup analysis in which calfactant therapy~     appeared to improve outcomes in immunocompromised children provide the rationale for~     assessing calfactant therapy in this patient population.~      Funding Source - FDA Office of Orphan Products Development (OOPD)~   "
195859|NCT00999700|"~     A phase III trial of induction chemotherapy followed by definitive radiotherapy plus~     Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of~     the head and neck (HNC).~   "
195860|NCT00999687|"~     The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract~     in treating nail psoriasis.~   "
195861|NCT00999674|"~     The present study aimed to investigate the effect of exercise program on health-quality of~     life (HQL) in older adults.~   "
195862|NCT00999661|"~     The purpose of this study is to evaluate the results patients are obtaining with the Realize™~     Adjustable Gastric Band-C during the first 24 months after surgery.~   "
195863|NCT00999648|"~     The objective of this study is to evaluate the efficacy of myofascial trigger (MTP) point~     deactivation for tinnitus control in a population with tinnitus and myofascial pain.~   "
195864|NCT00999635|"~     Importance of the topic:~      Lower extremity amputation is a costly complication of diabetes for both the NHS and the~     patient. Amputation may be avoided if the preceding foot ulceration can be prevented. One~     method of reducing the risk of ulceration in the neuropathic foot is through the provision of~     therapeutic insoles. The type of insole prescribed (prefabricated verses custom made) is~     currently based on anecdotal evidence. The idea held by many practitioners that the custom~     made insole is superior in its effect remains speculation, unsupported by the evidence. In~     the absence of economic analysis, the available data suggests that the custom insole is~     substantially more expensive to the NHS. This study, to determine which of two types of~     insole used in therapeutic shoes reduces peak pressure more in the at−risk diabetic foot, is~     therefore a very important topic and will provide both useful evidence for the NHS podiatry~     services. It is of course also very important for patients with diabetes as the personal~     suffering of those undergoing amputation is immense.~      The study is a single blind randomised controlled trial comparing custom made with 'off the~     shelf' insoles.~   "
195865|NCT00999622|"~     RATIONALE: Gathering information over time from laboratory tests of patients with newly~     diagnosed malignant supratentorial astrocytoma may help doctors learn more about the effect~     of treatment on white blood cell count and the risk of infection.~      PURPOSE: This clinical trial is studying blood samples and risk of infection in patients with~     newly diagnosed malignant supratentorial astrocytoma.~   "
195866|NCT00999609|"~     The study is a Phase 3, open-label, randomized controlled trial of gene therapy intervention~     by subretinal administration of AAV2-hRPE65v2 (voretigene neparvovec-rzyl). At least~     twenty-four subjects, three years of age or older, will be recruited. The intervention group~     will receive AAV2-hRPE65v2 at either The Children's Hospital of Philadelphia or University of~     Iowa to determine if it improves visual and retinal function in individuals with RPE65 gene~     mutations.~   "
195867|NCT00999596|"~     The purpose of this investigation, using hardcopy film, is to compare the accuracy of the~     Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of~     breast cancer among women undergoing screening or diagnostic mammography.~      Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no~     longer required.~   "
195868|NCT00999583|"~     The investigators hypothesised that the neuroprotective effects of erythropoietin and its~     analogues could lead to an improve outcome after cardiac arrest. To test this hypotheses, the~     investigators designed a randomized, multicentre, simple blind trial in which all~     participating patients will be receive usual treatments and 50% of them will also receive a~     high dose of epoetin alpha (an analogue of erythropoietin) in an add on fashion. The main~     end point will be the proportion of patients in each arm who will reach at day 60 the best~     level of recovery, using a 5 level score.~   "
195869|NCT00999570|"~     To determine whether specialty training or high volume of operative experience is associated~     with better clinical outcome and quality-of-life scores.~   "
195987|NCT00998023|"~     The purpose of this research study is to collect information on the amount of discomfort~     patients experience with one of two different vascular blood vessel closure devices, the~     MynxM5 Vascular Closure Device and the Angio-Seal Evolution Vascular Closure Device.~   "
195870|NCT00999557|"~     RATIONALE: Bimatoprost ophthalmic solution may help increase eyebrow and eyelash growth in~     patients who have undergone chemotherapy.~      PURPOSE: This randomized clinical trial is studying how wells bimatoprost ophthalmic solution~     works in increasing eyebrow and eyelash growth in patients who have undergone chemotherapy~     for breast cancer and in healthy participants.~   "
195871|NCT00999544|"~     Addressing the issue of opioid dependence and tolerance has public health implications for~     the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the~     treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in~     modulating both the acute and chronic response to opioids. The objective of this study is to~     determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist~     can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse~     liability and reinforcing effects.~   "
195872|NCT00999531|"~     The purpose of this study is to evaluate the safety and tolerability of repeated doses of~     GS-9411 in healthy volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway~     hydration and mucociliary clearance in the lung.~   "
195873|NCT00999518|"~     In a previous study in patients with interstitial cystitis/ painful bladder syndrome~     (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS,~     as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab~     was well tolerated. In this study, the hypothesis being tested is that tanezumab will show~     efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety~     will also be assessed at different dose levels~   "
195874|NCT00999505|"~     Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative~     and cognitive symptoms.~   "
195875|NCT00999492|"~     Given the availability of aspheric diffractive IOLs with varying negative spherical~     aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and~     thereby maximize visual performance.~   "
195876|NCT00999479|"~     The aim of this study is to determine whether or not continuous combined oral contraceptive~     pills (COCP's) decrease the risk of recurrent endometrioma formation. The investigators'~     hypothesis is that patients who have endometriomas surgically removed and then are started on~     COCP's will have a decreased incidence of recurrent endometrioma formation. The~     investigators' research protocol is designed to show a statistically significant decreased~     incidence of endometrioma formation in the hopes that physicians will use COCP's in patients~     they have removed an endometrioma in who do not desire immediate fertility. Long term, the~     investigators hope to establish a standard of care that COCP's be used postoperatively in~     appropriate candidates to decrease the chance of recurrent endometrioma formation.~   "
195877|NCT00999466|"~     AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis~     (hayfever). This study will be in two parts and will include 59 asthmatic patients in total.~     The first part will investigate the tolerability and safety of AZD8848 while the second part~     will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the~     drug.~   "
195878|NCT00999453|"~     Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in dialysis~     patients. Although significant improvements have been made in the management of CVD in the~     general population, it is not known whether these interventions would result in similar~     benefits in end stage renal disease patients.~      Clinical studies conducted in the general population and in patients with established~     cardiovascular disease have found a strong independent association between lipid lowering,~     primarily LDL-cholesterol, and the risk of all-cause and cardiovascular mortality.~      Therefore the National Cholesterol Education Panel (NCEP) has provided guidelines to lower~     LDL cholesterol levels to a goal of ≤100 mg/dl in patients with major risk factors of~     coronary heart disease. Moreover, the recent Adult Treatment Panel III (ATP III) guidelines~     provide an option to lower LDL cholesterol levels to a goal of <70 mg/dl in patients with~     very high risks for coronary heart disease.~      The National Kidney Foundation K/DOQI guideline regards dialysis patients as having high~     risks for coronary heart disease and consequently recommends the LDL cholesterol level to be~     maintained under 100 mg/dl. This recommendation is in parallel to the NCEP ATP III guideline~     which has been proposed for the general population. However, data regarding cholesterol~     levels in dialysis patients have been conflicting, with some observational studies~     demonstrating and some not demonstrating a clear, relationship between LDL and cardiovascular~     end-points. In addition few randomized studies have been conducted in CKD patients.~      An observational retrospective analysis of patients receiving hemodialysis, the U.S. Renal~     Data System Morbidity and Mortality Study, showed that the risk for cardiovascular mortality~     was decreased by 36 percent among patients receiving statins, compared to those who did not.~     Whereas, a most recent large prospective study in diabetic hemodialysis patients failed to~     demonstrate a significant reduction in cardiovascular endpoints with statin therapy.~      Moreover, although HD and PD patients both develop chronic hypervolemia and inflammation as~     common findings, the relationship between risk factors and outcome may differ between these~     two treatment methods. The likely role of glucose from the dialysate in causing dyslipidemia~     in PD patients inherits a different strength of association between cholesterol level and~     outcome in HD and PD patients.~      Therefore, this study aims to examine the clinical outcomes of treating chronic peritoneal~     dialysis patients with dyslipidemia to lower cholesterol levels, randomly assigning patients~     to either aggressive targets of LDL cholesterol of 70 mg/dl or current standard targets of~     LDLD cholesterol of 100 mg/dl.~   "
195879|NCT00999440|"~     QTc:~      Since the reports of three deaths attributed to Torsade de Point (TdP) related to treatment~     with the long-acting methadone derivative levomethadyl acetate HCl (LAAM), methadone has been~     scrutinized for any possible association with TdP. Since then, several studies among~     Methadone Maintenance Treatment (MMT) patients and chronic pain patients were done, reporting~     diverse results about possible association between methadone dose and QTc prolongation. Most~     studies however were cross-sectional and generally found insignificant clinical prolongation~     of QTc. A follow up studies are of importance, and although few studies have started~     evaluating QTc among MMT patients, none was done among chronic pain patients with no history~     of drug usage. One study of 8 chronic pain patients experiencing insufficient pain control or~     intolerable side effects during treatment with oral morphine switched to oral methadone~     showed insignificant modest increase QTc following 9 month.~      Perceived Sleep:~      Chronic pain patients as well as drug addicts are known to suffer from poor sleep. Some~     studies found possible relation to methadone dose, however, no causal association was found~     and importantly some also found association with duration of opiate usage before starting~     methadone when entry to MMT clinic. Thus, patients with no history of opiate addiction are an~     important interesting group that may help understand relation between methadone usage and~     sleep quality. However, sleep must be evaluate before opiate administration and a follow up~     study is needed~   "
195880|NCT00999427|"~     During a prostate biopsy, a needle is guided through the rectum into the prostate. Although~     patients are given antibiotics before the biopsy, there is still a risk of bacteria getting~     from the rectum into the bladder, prostate and bloodstream during the biopsy. For most~     surgical procedures, the surgical field is cleaned with antiseptic solution, but this is not~     common practice for prostate biopsies. In this study patients undergoing prostate biopsy will~     be randomly assigned to either receive an antiseptic preparation of the rectum or no~     preparation prior to biopsy, and the rate of infection after the biopsy will be determined.~   "
195882|NCT00999401|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) or~     recommended phase II doses of sapacitabine and seliciclib administered sequentially or~     concomitantly. The secondary objectives are to evaluate antitumor activity of this sequential~     or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin~     and peripheral blood mononuclear cells.~   "
195883|NCT00999388|"~     Background:~        -  Parkinson disease (PD) is the second most prevalent neurodegenerative disease, affecting~          more than 1 percent of the elderly population in the United States and other Western~          countries. Although effective treatments can alleviate symptoms in early PD, no cure or~          treatment slowing disease progression has been identified, and patients will eventually~          develop severe physical and mental disabilities and often die of complications. More~          research is needed on the causes of and appropriate preventive strategies for PD.~        -  The Shanghai Women s Health Study (SWHS) was established 10 years ago by investigators~          from the Vanderbilt University, the Shanghai Cancer Institute (SCI) and the National~          Cancer Institute (NCI) of the US. Their primary aim was to examine several unique~          dietary hypotheses on cancer among Chinese women. Researchers from the National~          Institute of Environmental Health Sciences and SWHS investigators are now interested in~          studying PD patients from SWHS to evaluate biological and environmental factors that may~          have put them at risk for PD.~      Objectives:~        -  To initiate a long-term prospective study on PD in Chinese women from the Shanghai Women~          s Health Study.~        -  To examine a set of biological and environmental factors that may raise or lower risk of~          developing PD.~      Eligibility:~      - All participants of the SWHS cohort are eligible.~      Design:~        -  Researchers will contact self-reported PD cases from the SWHS, confirm (or reject) the~          self-report, and invite them to a clinical examination at a coordinating hospital in~          Shanghai.~        -  Cases that confirm the self-report will be invited to visit the coordinating hospital~          for clinical examinations, including a PD clinical workup, blood and urine collections,~          a cognitive assessment and relevant neuropsychological testing, and an interview on~          additional risk factor exposures that are not available from baseline surveys.~        -  For those who could not participate in the clinical examination, researchers will ask~          for a few details about the diagnosis and treatment history and ask for permission to~          obtain medical records relevant to PD diagnosis from government or hospital agencies.~        -  For self-reported PD cases who are now deceased, researchers will follow a similar~          procedure by asking for consent and help from the next-of-kin.~   "
195884|NCT00999375|"~     Background:~        -  Type 1 diabetes (T1D) is a common chronic disease in children, occurring in~          approximately 1 of every 400 to 600 children. Children with T1D are unable to produce~          insulin, a hormone that allows the body to use glucose from food. Children with T1D~          manage their diabetes by taking insulin, monitoring their blood glucose levels, and~          watching their diet, including carbohydrates.~        -  Carbohydrates come from many different kinds of food, and recent research has shown that~          different foods have a different effect on the level of glucose in the blood. In~          general, whole, unprocessed foods (e.g., fruits, vegetables, whole grains, legumes) have~          a lower glycemic index (GI), which means that they cause smaller, more sustained blood~          sugar levels. Additionally, these foods are rich in nutrients. Nutrient-poor~          carbohydrates come from foods made with refined grains and sugars, such as breads,~          crackers, and breakfast cereals; they general cause a more rapid increases in blood~          sugar (i.e., a high GI). Lower GI diets may help people with T1D manage their blood~          glucose levels more easily.~      Objectives:~        -  To determine the utility of a whole foods, low GI diet in the management of T1D.~        -  To determine the utility of a behavioral intervention to promote healthful family~          dietary behaviors, including eating more fruits, vegetables, whole grains, and legumes,~          and fewer refined carbohydrates.~        -  To determine how the dietary intervention affects quality of life, satisfaction with the~          diet, and risk for problem eating behaviors.~      Eligibility:~      - Children 8 to 16 years of age who have been diagnosed with T1D for more than 12 months, and~     who use insulin injections to maintain normal blood glucose levels.~      Design:~        -  Families will be divided into two groups: an intervention group that will participate in~          intensive dietary intervention and continuous glucose monitoring (CGM) and a control~          group that will not have the dietary intervention but will have CGM and scheduled~          contacts with study staff.~        -  Intervention group families will have 11 family-based and 2 group-based sessions~          consisting of behavioral techniques and educational content about eating nutrient-dense,~          low GI foods. CGM results will give families feedback about how their diet affects blood~          glucose levels. At least one parent and the child with T1D will participate in the~          intervention.~        -  Intervention topics will consist of goal setting, behavior self-monitoring, educational~          information, and problem solving, among others. Parents and children will record the~          foods they eat.~        -  Control group families will participate in 11 family-based sessions consisting of CGM~          feedback.~        -  Assessments will be conducted at 6, 12, and 18 months, and medical record information,~          including blood and urine testing, will be obtained at each routine clinic visit.~   "
195885|NCT00999362|"~     The purpose of this study is to determine whether calcineurin phosphatase in the~     T-lymphocytes is up-regulated after long-term treatment with tacrolimus, a calcineurin~     inhibitor.~   "
195886|NCT00999349|"~     Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant,~     hepatoprotective and iron chelating activities. The present study has been designed to~     investigate the therapeutic activity of orally administered silymarin in patients with~     thalassemia major under conventional iron chelation therapy. A 6-month randomized,~     double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two~     well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three~     times a day plus conventional desferrioxamine therapy or the same therapy but a placebo~     tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are~     assessed at the beginning and the end of the trial.~   "
195887|NCT00999336|"~     The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and~     tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to~     healthy volunteers.~   "
195888|NCT00999323|"~     The objective of this study is to evaluate whether impaired endothelial function and low~     heart rate variability are associated with clinical restenosis after percutaneous coronary~     intervention with stent implantation in patients with angina or acute coronary syndrome.~      Furthermore, the study examines a potential correlation between biomarkers of endothelial~     cell activation and endothelial dysfunction.~   "
195889|NCT00999310|"~     The purpose of this study is to investigate the following:~        1. Whether Klinefelter Syndrome is associated with altered total and regional brain volumes~          and altered brain activity.~        2. The influence of genetic factors and testosterone treatment on the neuropsychological~          phenotype, total and regional brain volumes and brain activity in men with Klinefelter~          syndrome.~   "
195890|NCT00999297|"~     A 4 week intake of drug to find a natural substance that may modify energy balance and may~     enhance health in combination with lifestyle changes with possible decrease in body weight.~   "
195891|NCT00999284|"~     ZK 200775 is an antagonist at the α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA)~     receptor and had earned attention a possible neuroprotective agent in cerebral ischemia.~     Probands receiving the agent within a stroke therapy related Phase I trial reported on an~     alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system~     will be analyzed in detail.~      In a randomised, placebo-controlled, double-blind study eyes and vision will be examined~     before and after the intravenous administration of ZK 200775. The following methods will be~     applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute~     threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and~     full-field electroretinogram (ERG).~   "
195892|NCT00999271|"~     The aim of this proposal is to examine whether endogenous GIP and exogenous GIP alone and in~     combination with insulin affect gastric emptying (GE), appetite, energy intake, energy~     expenditure (EE) and plasma levels of triglycerides (TAG), free fatty acids FFA) and glycerol~     in man.~   "
195893|NCT00999258|"~     The objective of this study is to examine the effect on allograft function and histology of~     converting African American renal transplant recipients with chronic allograft nephropathy~     (CAN) from a tacrolimus-based regimen to a sirolimus-based maintenance immunosuppression~     regimen.~      The investigators hypothesize that the conversion from tacrolimus to sirolimus in African~     American renal recipients will stabilize or improve renal allograft function, and stabilize~     the histological progression of CAN. This conversion will have the potential to prolong~     long-term graft survival in African American renal transplant patients.~      GFR measurements, histological parameters on the allograft biopsy, as well as patient and~     graft survival, incidence of acute rejection, and specific side effects will be monitored and~     compared between the sirolimus conversion group and the patients who will be maintained on~     tacrolimus.~   "
195894|NCT00999245|"~     Patient-Controlled Analgesia (PCA) means that the patient is in control of his/her pain~     medicine. In this study two (2) different treatment plans of Patient-Controlled Analgesia~     will be used to treat people with sickle cell disease who are admitted to the hospital for a~     pain crisis. The purpose of this study is to find out if one plan is better than the other in~     controlling sickle cell pain.~      If you are eligible for the study, you will be assigned by chance (like flipping a coin) to~     either get a higher continuous amount of the pain medicine with a smaller amount for pain as~     you need it, OR to get a smaller continuous amount of pain medicine with a larger amount of~     pain medicine as you need it. You or your study doctor can not choose which plan you receive,~     and you will not be told which one you have been assigned to. The doctors and nurses taking~     care of you will know which plan you are assigned to so they can safely and effectively take~     care of your pain. Some members of the study team will not know which plan you are on.~      We will give you morphine sulfate or hydromorphone (dilaudid) for your pain. These medicines~     are approved by the Food and Drug Administration (FDA) and have been used for a long time to~     relieve pain. If you have been treated for pain before with hydromorphone (dilaudid) and you~     prefer it to morphine, then you may choose to get it during the study. If you have not~     received hydromorphone (dilaudid) before or you do not have a preference then you will be~     given morphine for pain.~      The pain medicine will be given through the IV in your arm. You will receive morphine or~     hydromorphone continuously through the IV and will also be able to use the PCA machine to~     give yourself extra pain medicine as you need it for pain. You will need to push a button to~     give yourself extra medicine for pain. The amount of pain medicine you get on these plans is~     based on how much you weigh.~   "
195895|NCT00999232|"~     The purpose of this study is to assess the effect of erythromycin on the Rate of Success in~     Placement of a Self-propelled Feeding Tube.~   "
195896|NCT00999219|"~     This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by~     polysomnography in patients with insomnia, excluding patients with schizophrenia or~     manic-depressive psychosis.~   "
195897|NCT00999206|"~     A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived~     seasonal trivalent subunit influenza vaccine in adult and elderly subjects without~     significant illnesses and to demonstrate consistency of the immunogenicity of the three lots~     of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine~     including assessment of non-inferior immunogenicity~   "
195898|NCT00999193|"~     Fractures of the proximal humerus are common in elderly patients. The optimal treatment of~     comminuted, displaced fractures is subject to controversy, and the results of operative~     treatment have not been shown to be superior to conservative treatment. The aim of the study~     is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty~     versus conservative treatment in a randomised, controlled protocol. The results of treatment~     are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures~     are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant~     Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm,~     Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction~     and costs. The study also has a cohort follow-up of the patiens who decline randomisation.~   "
195899|NCT00999180|"~     The objective of this study is to assess if the association of botulinum toxin type A and~     kinesitherapy is superior to kinesitherapy and 0,9% saline for the functional performance in~     post-stroke patients.~      Hypothesis H(0): BT-A associated to kinesitherapy is not superior to kinesitherapy in the~     function of hemiparetic post-stroke patients.~      H(1): BT-A associated to kinesitherapy is superior to kinesitherapy in the function of~     hemiparetic post-stroke patients.~   "
195900|NCT00999167|"~     This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of~     an open label safety lead-in (Part A), followed by randomized, double-blind,~     placebo-controlled treatment (Part B).~   "
195901|NCT00999154|"~     Background:~      - Obesity is the result of many factors, including genetics and lifestyle, such as~     over-eating high-calorie foods and not being physically active. Obesity affects approximately~     one third of adults in the United States. Researchers often study individuals who are already~     overweight and obese, but another approach is to examine people who stay thin despite eating~     whatever they want and not exercising. Studying these thin individuals will enhance~     understanding of why some people become obese and others do not, which may lead to novel~     treatments for obesity.~      Objective:~      - To study the metabolism, body composition, body temperature, physical activity, and blood~     chemistries of healthy lean adults before and after adding 1,000 extra Calories per day to~     their normal diet.~      Eligibility:~      - Healthy adults, 30 to 50 years of age, who have never been overweight after adolescence,~     who are currently weight-stable, sedentary, and eating without restrictions.~      Design:~      - The entire study will take about 9 weeks and will include the following outpatient and~     inpatient visits:~      <TAB>- Outpatient screening visit and monitoring: Physical examination and blood test at~     screening; then, one week of physical activity monitoring (e.g., with a pedometer-like device~     called an accelerometer) and completing a food diary.~      <TAB>- Baseline inpatient visit (5 days): Volunteers will eat a normal diet to maintain body~     weight. Energy expenditure, body composition, physical fitness, activity level, and eating~     behavior will be measured. Urine and blood samples will be taken. Volunteers may go home for~     the weekend or stay at the metabolic clinical research unit (MCRU).~      <TAB>- Inpatient feeding week 1 (5 days): Volunteers will eat a normal diet plus milkshakes~     for added calories. All the same measurements during the baseline week visit will be~     repeated.~      <TAB>- Outpatient feeding weeks 2 3: Volunteers will eat breakfast at the MCRU everyday for~     the next 2 weeks and take prepared meals home with them (volunteers may also stay at the MCRU~     for the 2 weeks if they prefer). Volunteers will drink a non-radioactive (heavy) water called~     doubly labeled water to measure energy expenditure in their normal living environment Daily~     urine samples will be collected.~      <TAB>- Inpatient feeding week 4 (5 days): Volunteers will continue eating a normal diet plus~     milkshakes for added calories. This stay and measurement is identical to inpatient feeding~     week 1.~      - Volunteers will be contacted at 6 and 12 months to assess any changes in body weight, diet,~     and physical activity.~   "
195902|NCT00999141|"~     The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus~     standard of care in adhering tissue and improving wound healing in subjects undergoing~     facelift.~   "
195903|NCT00999128|"~     This is a Phase I, randomized, two-part, single-center pharmacokinetics (PK) study to assess~     the relative bioavailability of capsule and tablet formulations of GDC-0941 in the fasted~     state (Part 1) and to determine the effect of food and proton pump inhibition on the PK of~     the tablet formulation of GDC-0941 (Part 2). Approximately 18 subjects will be enrolled in~     Part 1 and up to 32 subjects will be enrolled in Part 2. Subjects who participate in Part 1~     are not eligible to participate in Part 2.~   "
195904|NCT00999115|"~     The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded~     adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s~     disease.~   "
195905|NCT00999102|"~     Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is~     a recognized and common side effect of beta-blockers that can have significant effects on~     quality of life. Worse, many people taking a beta-blocker for years are not even aware of the~     reduction of energy with which they are living.~      A new vasodilating beta-blocker, nebivolol, which is approved by the FDA for treatment of~     hypertension, appears to be far less associated with fatigue than are most currently~     available beta-blockers. The purpose of this study is to compare nebivolol with the current~     best-selling beta-blocker, metoprolol, and determine whether there is a significant~     difference in side effects including fatigue, reduced exertion tolerance, and reduced quality~     of life.~      In this study, 30 subjects will take each of the 2 study drugs for 8 weeks, consisting of 4~     weeks at a lower dose, and 4 weeks ata higher dose. All dosages are FDA-approved for~     treatment of hypertension. Subjects and investigators will not know which drug is being~     administered until completion of the study. Subjects will undergo a treadmill stress test and~     will complete fatigue and quality of life questionnaires after each 4 weeks of treatment. An~     echocardiogram and non-invasive measurement of aortic blood pressure will be performed after~     8 weeks on each drug. Also, blood will be drawn and stored for possible measurement of drug~     levels, after 4 and 8 weeks on each drug. Results on each drug will then be compared. If~     nebivolol is found to cause significantly less fatigue, it would be of substantial importance~     to the many millions of people who are on life-long beta-blocker therapy, and are living with~     reduced energy.~   "
195906|NCT00999089|"~     The individual contribution of the specific injuring mechanisms surgical trauma,~     extracorporeal circulation, and ischemia/reperfusion to clinical outcome in coronary~     revascularisation remains to be elucidated. The effect of these factors is analyzed in this~     randomized clinical trial by comparing the 3 surgical approaches: Conventional Coronary~     Artery Bypass Grafting (CCAB), with extracorporeal circulation and cardioplegic arrest;~     Off-Pump Coronary Artery Bypass Grafting (OPCAB), avoids extracorporeal circulation and~     global myocardial ischemia; and Pump-Assisted Coronary Artery Bypass Grafting (PACAB), with~     an unloaded and beating heart. The hypothesis addressed by the study is that the surgical~     invasiveness increases in the order: OPCAB, PACAB, CCAB.~   "
195907|NCT00999076|"~     The aim of the study is to evaluate the polymerase chain reaction (PCR)-Reverse Blot~     Hybridization Assay (REBA) for identification of nontuberculous mycobacteria (NTM) species in~     acid-fast bacilli (AFB) smear-positive respiratory specimens.~   "
195908|NCT00999063|"~     This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000~     patients who suffer with upper gastrointestinal tract symptoms. Each patient will be assessed~     for GERD with GerdQ Thai Version.~   "
195909|NCT00999050|"~     The aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in~     controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be~     the reduction of HbA1c (< 7%), a standard measure of diabetes control; the secondary~     endpoints will be changes blood sugar , vitamin levels, insulin, c-peptide, and lipids~     levels, as well as retinal eye examinations, urinalysis to assess kidney function, carotid~     ultrasound as a marker of cardiovascular function, and alterations in diabetic medications.~     Fifty subjects with medically documented type 2 Diabetes Mellitus (T2DM) with BMIs between 26~     and 35 will undergo standard laparoscopic RYGB. Prior and after surgery, the subjects will~     undergo a clinical evaluation in regard to the primary and secondary endpoints listed. The~     pre-surgery evaluation is directed toward establishing the existence of diabetes related~     complications prior to surgery. After surgery subjects will be closely monitored for~     complications and required changes in their diabetes management. Repeat assessments will be~     made at 1, 3, 6, and 12 months and at two years.~   "
195910|NCT00999037|"~     FGF-23 is a newly described protein that is an important regulator of phosphorus in the body.~     This protein increases in people with kidney disease and people who need dialysis have very~     high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23~     levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be~     lowered in patients with kidney disease by preventing them from absorbing phosphorus from~     food. This study is designed to see what happens to levels of FGF-23 in the blood when~     patients with chronic kidney disease take medications to prevent phosphorus absorption. Since~     high levels of FGF-23 have been linked with increased rates of death in patients with~     advanced kidney disease, controlling the levels may, in the future, be a way to decrease~     heart disease in patients with kidney disease.~   "
195911|NCT00999024|"~     An adequate oxygenation and retinal perfusion is essential for the function of the inner~     retina. There is a wide range of autoregulation mechanisms to ensure a sufficient ocular~     blood and oxygen supply during changes in systemic blood pressure or intraocular pressure~     (IOP). Nonetheless, various retinopathies such as diabetic retinopathy, which is the leading~     cause of blindness in people aged 20-65 in the western world, are highly associated with~     hypoxia (Pemp and Schmetterer 2008). Hence, measurements of oxygen levels in retinal vessels~     are needed to further our understanding of these ischemic diseases. It is a well known fact~     and a commonly employed method to measure oxygen saturation of blood through light~     transmission (Kramer 1934). However, this approach is not feasible in the human eye.~     Therefore, reflection must be used, meaning the amount of incident light must be estimated~     based on the amount of light reflected (for a review see Harris 2003). This is a difficult~     task and investigators in this field have encountered several problems, including optical~     complexities, nonlinear sensors and eye movement (Beach et al 1999; Delori 1988). Nonetheless~     considerable progress has been made over the past decades and the development of an reliable~     oximeter reported (Hardarson et al 2006).~      In the present study this technique will be applied in healthy subjects as well as in~     patients with COPD during room-air conditions. The procedure takes approximately 15 minutes~     in each subject and will be performed in only one eye.~   "
195912|NCT00999011|"~     This study will examine the effects of once and twice daily activity performed with patients~     who are breathing with the aid of a machine in an intensive care unit. Activity can occur in~     bed. Activity can include transfer to a chair and even walking once the patient's condition~     allows safe, out-of-bed activity. The investigators hypothesize that early, progressive~     activity will reduce inflammatory molecules in the blood, promote muscle and physical health~     and help patients to recover more quickly from critical illness.~   "
195913|NCT00998998|"~     The purpose of this study was to determine if a home-based intervention to foster child~     development improved behavior and development in infants with IDA.~   "
195914|NCT00998985|"~     This multiple dose study will assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)-~     infected participants. The primary hypothesis is that administration of grazoprevir for 7~     days is sufficiently safe and well tolerated in HCV-infected males.~   "
195915|NCT00998972|"~     The goal of this study is to evaluate the effect of N-acetyl-cysteine (NAC) administration in~     organ donors on the kidney graft function of recipients.~   "
195916|NCT00998959|"~     The purpose of this study is to determine the usefulness of a stress reduction treatment in~     helping minority patients with major depression get better. Subjects will receive six weeks~     of either mindfulness-based stress reduction and problem solving therapy or psychoeducation.~   "
195917|NCT00998946|"~     The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and~     folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's~     lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12~     and folic acid in this patient population. Additionally, this study includes the collection~     of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient~     population (PK is the activity of a drug in the body over a period of time, including how the~     drug is absorbed, distributed in the body, localized in the tissues, and excreted from the~     body).~   "
195918|NCT00998933|"~     To further characterize the transfer potential of marketed testosterone gel and new 1.62%~     formulation.~   "
195919|NCT00998920|"~     The purpose of this study is to evaluate the safety and tolerability of escalating multiple~     doses of S-equol administered twice daily (BID) for 14 days to healthy male and female~     subjects and to describe the pharmacokinetic profile of S-equol.~   "
195920|NCT00998907|"~     The aim of this study is to ascertain if the use of PDS plus® reduces the number of wound~     infections and incisional hernia after midline and transverse laparotomy comparing to~     polyglactin suture.~   "
195921|NCT00998894|"~     The investigators propose to test the theory that smart alarms for the Triple Low State~     incorporated into a decision support system built into an electronic anesthesia record will~     prompt clinicians to intervene earlier in situations that would otherwise provoke little~     concern, and that the alert system will reduce 90-day mortality. Specifically, the~     investigators will test the hypothesis that providing Triple Low alerts reduces 90-day~     mortality.~   "
195922|NCT00998881|"~     The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in~     patients with type 2 Diabetes for 12 weeks administration.~   "
195923|NCT00998868|"~     The purpose of the study is to evaluate the prevalence of rotator cuff tears in the shoulders~     of hemiplegic patients of different severity.~   "
195924|NCT00998855|"~     A 12 wk aerobic exercise program will reduce visceral, hepatic and intramyocellular fat~     accumulation and improve insulin sensitivity and glucose metabolism in obese sedentary~     Hispanic adolescents.~   "
195925|NCT00998842|"~     To determine if there is a difference between wireless ECG and wired ECG findings.~   "
195926|NCT00998829|"~     This study aims to collect Australian data on the prevalence of undiagnosed psoriatic~     arthritis in patients with plaque psoriasis. In addition the study will assess disease~     severity and quality of life in Australian patients with psoriasis attending specialist~     dermatology clinics.~   "
195927|NCT00998816|"~     Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the~     likelihood of chronic post-thoracotomy pain syndrome (CPTPS).~   "
195928|NCT00998803|"~     Influenza virus infections are a major cause of morbidity and mortality. The limited existing~     knowledge about the impact of influenza in immunocompromised patients suggests that they are~     at increased risk of influenza virus acquisition, of developing complications and of~     prolonged illness and viral shedding. However, some other data about the effect of antiviral~     agents on the infection course, and risk of resistance in immunocompromised children are~     lacking. The emergence of the pandemic H1N1 swine-origin influenza A virus has generated an~     additional need to study the epidemiology, clinical course and outcome of influenza~     infections in immunocompromised children. This study proposed to conduct a prospective~     observational clinical study to answer these questions.~   "
195929|NCT00998790|"~     A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence.~     The purpose of this study is to obtain surgical technique data for use in physician education~     and training and to collect early clinical outcomes data for future publication. This study~     is not designed to statistically demonstrate safety and efficacy of the device.~   "
195930|NCT00998777|"~     The primary purpose of this study is to assess changes in shoulder muscle strength, shoulder~     movement, shoulder flexibility, muscle thickness, upper arm torsion angle, and subacromial~     width (space where the rotator cuff muscle passes through) after completing a 6-week shoulder~     strengthening and stretching program in division I collegiate swimmers. The result of this~     study may demonstrate the effectiveness of a strengthening and stretching program to~     positively influence factors that have been associated with pain and injury in division I~     collegiate swimmers and indicate the need to implement this program for the entire team.~     Following a 6-week strengthening and stretching program, it is believed that scapular~     kinematics, shoulder flexibility, and shoulder and scapular stabilizer strength will be~     improved compared to control subjects.~   "
195931|NCT00998764|"~     The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab~     in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over~     250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each~     subject's participation will last approximately 4 years.~   "
195932|NCT00998751|"~     The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the~     treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.~   "
195933|NCT00998738|"~     This randomized phase III trial studies calcium and magnesium to see how well they work in~     preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer. Giving~     calcium together with magnesium may stop or delay the development of peripheral neuropathy in~     patients with cancer who are receiving treatment with ixabepilone. It is not yet known~     whether calcium and magnesium are effective in preventing peripheral neuropathy caused by~     ixabepilone.~   "
195934|NCT00998725|"~     The purpose of this research study is to learn about the birth control pill called LoFemenal~     in HIV+ and HIV negative women who live in Malawi. This is a pilot study to determine the~     effect of antiretroviral therapy on the pharmacokinetics of the most commonly used oral~     contraceptive in HIV+ women; and to measure ovulation suppression in women taking the oral~     contraceptive pill and antiretroviral therapy at the same time. Nine women will be enrolled~     and will be followed for a total of 4 months.~   "
195935|NCT00998712|"~     The purpose of this research study is to look at whether there are differences in blood~     vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels,~     and levels of other blood markers between black women and white women who have or do not have~     gestational diabetes mellitus.~   "
195936|NCT00998699|"~     The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell~     regeneration.~      The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and~     insulin production.~   "
195937|NCT00998686|"~     The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over~     52 weeks.~   "
195938|NCT00998673|"~     Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue~     growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and~     will be hold in place by a secondary dressing for maintaining the moist wound environment.~     The study is aimed to demonstrate superiority over a standard wound treatment for chronic~     venous leg ulcers. The primary efficacy variable is time to healing.~   "
195939|NCT00998660|"~     The purpose of this study is to assess the recharge feature of the Activa RC System in~     patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD),~     Essential Tremor (ET), or dystonia.~   "
195940|NCT00998647|"~     The purpose of this study is to find out, whether filtration of the blood in patients~     undergoing cardiac surgery, beneficially influences the coagulation system.~   "
195941|NCT00998634|"~     The purpose of this study is to determine safety and tolerability of the treatment with~     lithium in Spinocerebellar Ataxia 2. Moreover, clinical symptoms, neuronal loss, quality of~     life and depressive symptoms, will be considered to further investigate the effect of lithium~     therapy.~   "
195942|NCT00998621|"~     Main objective: To study and validate a questionnaire measuring treatment adherence in~     patients with Hepatitis C virus (HCV) infection.~      Design of the study: Multicentric, prospective, epidemiological study in the field of usual~     clinical practice.~   "
195943|NCT00998608|"~     The purpose of this study is to compare the efficacy and safety of risperidone and~     risperidone plus low dose of haloperidol in the acutely schizophrenic patients.~   "
195944|NCT00998595|"~     The primary hypothesis underlying this proposal is that the introduction of a Promotora to~     provide education and proactive follow-up to women with GDM will increase compliance with~     postpartum glucose tolerance testing. The secondary hypothesis is that the Promotora will~     improve participation in referral visits for diabetes or preventive care. We will develop the~     promotora program and begin pilot implementation.~   "
195945|NCT00998582|"~     Recent research as suggested that use of the HIV medication abacavir (Ziagen, or~     co-formulated with lamivudine as Epzicom) may increase risk for heart disease, though~     findings from multiple studies have been inconsistent. This pilot study will examine vascular~     function, a marker of heart disease risk, among patients taking abacavir as part of their HIV~     medications and are then randomized to: 1) switch to tenofovir, another HIV medication, or 2)~     continue to take abacavir.~   "
195946|NCT00998569|"~     The purpose of this study is to examine the effects of neurocognitive enhancement on~     cognitive abilities and related social and adaptive behaviours in individuals diagnosed with~     major depressive disorder. Subjects in this study will be randomized to receive~     Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET . Secondary aims~     include examining whether the cognitive benefits are potentiated by repeated exposure during~     in-home practice with complementary exercises. Additionally, the investigators will examine~     the durability of the effects and their generalization to functional capacity and everyday~     functional performance after completion of the groups.~   "
195947|NCT00998556|"~     This is a randomized, controlled clinical trial to evaluate the efficacy and safety of~     bromocriptine for improvement of left ventricular function of women with Peripartum~     cardiomyopathy (PPCM). A Multi center trial in Germany.~   "
195948|NCT00998543|"~     The purpose of this study is to provide long-term follow-up immunogenicity and safety data on~     participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04~     (NCT 00258947).~      Primary Objectives:~      Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years~     post-vaccination.~      Safety: To follow-up the long-term safety up to 5 years post-vaccination.~   "
195949|NCT00998530|"~     The hypothesis to be tested in this trial is that the different epidemiologic (including~     racial differences) and phenotypic manifestations exhibited by Trichomonas clinical isolates~     during infection are correlated with their genotypic strain classification. Two specific aims~     are proposed to test that hypothesis. Specific aim 1. Assess the significance of genotypic or~     phenotypic differences in the Trichomonas strains among African American women by HIV status.~     Specific aim 2. Determine the significance of genotypic or phenotypic differences in the~     Trichomonas strains circulating among women from two different racial groups, African~     American women and Caucasian women. The overall goals of these specific aims are to identify~     racial differences in the genotypic and phenotypic characteristics of Trichomonas strains,~     and to develop the ability to identify and classify Trichomonas infections in order to~     prioritize treatment and epidemiologic follow-up of individuals infected with isolates~     associated with adverse clinical outcomes (HIV transmission or acquisition, pregnancy~     complications, virulence, or drug resistance).~   "
195950|NCT00998517|"~     The purpose of this study is to compare the recovery rates of moderately malnourished~     Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified~     spread or a commercially produced ready-to-use therapy food.~   "
195985|NCT00998049|"~     Rationale: Giving colony-stimulating factors, such as G-CSF and plerixafor helps stem cells~     move from the patient's bone marrow to the blood so they can be collected and stored.~     Purpose: This phase II trial is studying how well plerixafor works in patients with multiple~     myeloma previously treated with lenalidomide and planning to undergo autologous stem cell~     transplant.~   "
195951|NCT00998504|"~     There is now a general consensus that the combination of excessive energy intake and a low~     capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. It is~     known for many years that physical exercise is the most powerful treatment to combat insulin~     resistance, but it is also known that it is difficult to get people to exercise. A major~     breakthrough has come from the nutrition field, with the finding that resveratrol, a natural~     polyphenolic compound, could serve as an exercise mimetic by protecting mice from many~     detrimental effects of diet-induced obesity. Therefore the researchers would like to~     investigate if resVida can increase skeletal muscle mitochondrial function and fat oxidative~     capacity in obese subjects. The researchers hypothesize that an increased mitochondrial~     function together with an increased intrinsic activity will lead to a better control of fatty~     acid handling in muscle, upon a high-fat challenge.~   "
195952|NCT00998478|"~     The purpose of this study is to investigate the effects of a cross-curricular physical~     activity intervention on cardiovascular disease risk factors in 11-14 year olds. The null~     hypothesis states that the intervention will have no effect on cardiovascular disease risk~     factors.~   "
195953|NCT00998465|"~     The purpose of this study is to evaluate the effect of high vs. low sodium intake on blood~     pressure and system hemodynamics in patients with morbid obesity and to evaluate the impact~     of laparoscopic gastric bypass on blood pressure, salt sensitivity and body composition in~     morbidly obese patients. Furthermore, we wants to describe the hemodynamic mechanisms~     involved in the amelioration of blood pressure during long-term weight loss.~   "
195954|NCT00998452|"~     This study is being conducted with the Veterans Affairs National Center for Health Promotion~     and Disease Prevention (VANCP), which is overseeing the current dissemination of MOVE!~     (Managing Overweight/Obesity for Veterans Everywhere), a national weight management program~     for veterans. It will be based at 10 local sites in the national network of VA medical~     settings and community-based outpatient clinics and will compare two different models for~     disseminating and implementing MOVE! using a randomized experimental design. One study arm~     will implement the MOVE* VETS! (Volunteer Education and Tailored Self-management and support)~     model that includes tailored newsletters and peer counseling MI calls and activities, and the~     other will receive the standard MOVE! program.~   "
195955|NCT00998439|"~     The aim of the study is to assess the efficacy of the Paclitaxel-eluting PTCA - balloon~     catheter SeQuent® Please to treat in-stent restenoses (ISR) of various drug eluting stents in~     native coronary arteries with reference diameters between 2.5 mm and ≤ 3.5 mm and lesion~     lengths ≤ 22 mm. The vessel patency following treatment with SeQuent® Please will be~     documented in ISR patients that have been treated with the Cypher® or Taxus® drug eluting~     stent.~   "
195956|NCT00998426|"~     HepaGam B Hepatitis B Immune Globulin (HBIG) solution contains 10% maltose, which could~     possibly interfere with the measurement of glucose levels when using glucose non-specific~     tests. The purpose of this study is to determine whether use of HepaGam B HBIG shows an~     increase in glucose levels in the body using non-specific glucose monitoring, as well as~     specific glucose monitoring. The sponsor believes that this medication will not cause a~     significant increase in glucose levels in the body when measured by glucose non-specific~     tests.~   "
195957|NCT00998413|"~     The purpose of this study is to determine the efficacy of a multifactorial intervention with~     weight reduction, behavioural therapy, and physical exercise on the severity and control of~     asthma in obese children.~   "
195958|NCT00998400|"~     Emotional states of depression in association with ischemic heart diseases, such as~     myocardial infarction or unstable angina, are risk factors for subsequent cardiac events and~     mortality. However, the only psychological intervention trial attempting to reduce cardiac~     risk in depressed ACS patients showed that changes in depression did not translate into~     improved survival. Such intervention did not address issues such as lifestyle modification~     and improvement in psychological well-being, which were found to affect individual~     vulnerability to medical disease. Our research group has developed a well-being enhancing~     psychotherapeutic strategy, well-being therapy (WBT), which has been validated in a number of~     clinical trials. The aim of this project is to evaluate the efficacy of cognitive behavioral~     treatment (CBT) together with lifestyle modification and WBT in reducing cardiac risk in~     depressed and/or demoralized ACS patients compared to a standard clinical procedure of~     patients' management, the clinical management (CM). The same protocol will be carried out in~     two centres (Bologna and Torino). 100 patients after a first episode of myocardial infarction~     or unstable angina, meeting DSM-IV criteria for depressive disorders and DCPR criteria for~     demoralization will be randomized to one of two treatment groups: 1) CBT supplemented by~     lifestyle modification and WBT; 2) CM. In both groups, treatment will consist of twelve,~     45-minute sessions once a week. A two-year follow-up will be performed. It is expected that~     psychological treatment may significantly decrease cardiac morbidity and mortality at~     follow-up compared to clinical management. The findings may entail considerable preventive~     implications and possible large reductions in health costs.~   "
195959|NCT00998387|"~     The purpose of this study is to translate and validate the CAM-ICU for use in the Korean ICU~     setting.~   "
195960|NCT00998374|"~     This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that~     rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes~     reactive hypoglycemia. It is believed that the controlled release offered by an intact~     pylorus will be advantageous for long term results in bariatric surgery. This study can~     provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery,~     such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as~     compared to non-pyloric sparing surgery, namely the gastric bypass.~   "
195961|NCT00998361|"~     This is a perspective multicentric study for the treatment of patients aged equal or less~     than 60 years and submitted to an allogeneic hematopoietic stem cell transplantation from an~     HLA compatible related or unrelated donor because affected by resistent or refractory or~     relapsed after autologous stem cell transplantation Ewing Sarcoma or Soft tissues sarcoma who~     did not benefit from conventional therapy.~   "
195962|NCT00998348|"~     This purpose of this project is to determine whether this 8-month parenting for healthy~     weight intervention is able to help parents improve their parenting skills and make positive~     changes in the nutrition and physical activity environment at home.~   "
195963|NCT00998335|"~     The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty~     liver disease (NAFLD) has not been systematically studied before, and in particular, never~     when using the new insulin formulations detemir (Levemir®) or aspart (Novolog®). This study~     is to determine the effect on hepatic steatosis and insulin secretion/action of lowering the~     fasting plasma glucose (FPG) to target with once daily basal insulin detemir alone or~     combining insulin detemir with premeal insulin aspart in patients with uncontrolled type 2~     diabetes mellitus (T2DM).~      In the first 3 months the investigators will optimize metabolic control in all patients with~     intensive basal (bedtime) detemir insulin aiming at a normal fasting plasma glucose. After~     this treatment period, patients will be randomized in the second 3 months in a 2:1 ratio to~     insulin detemir or detemir plus aspart. The investigators propose that insulin will improve~     day-long glycemic control and A1c, reduce hepatic steatosis (NAFLD) (primary endpoint) and~     insulin secretion/sensitivity being well tolerated while causing minimal weight gain and~     hypoglycemia (secondary endpoints). The study will allow to assess if there is an additional~     benefit of adding pre-meal rapid-acting insulin aspart to basal insulin to these endpoints.~   "
195964|NCT00998322|"~     The purpose of this Phase 2 study is to investigate whether intravenous administration of~     REOLYSIN therapeutic reovirus in combination with gemcitabine is effective and safe in the~     treatment of patients with advanced pancreatic cancer.~   "
195965|NCT00998309|"~     To collect the efficacy and safety information of Zithromax-SR related to their appropriate~     use in daily practice.~   "
195966|NCT00998296|"~     The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the~     combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide~     dosing recommendation for subsequent phase II trials in patients with metastatic cancer.~   "
195967|NCT00998283|"~     -  Study Design~             -  Randomized, Double-blind, Placebo-controlled, escalating single-dose design.~             -  Five ascending dose cohorts.~             -  In each cohort, subjects will be randomized to receive a single dose of HM10460A or~               placebo (negative control)~        -  Objectives~             -  The primary objective of the study is to assess the safety and tolerability of~               single escalating subcutaneous doses of HM10460A in healthy adult Korean Subjects~   "
195968|NCT00998270|"~     A prospective, randomized trial of autologous bone marrow transplantation compared with~     allogeneic bone marrow transplantation in multiple myeloma.~   "
195969|NCT00998257|"~     The objective of this Post Marketing Surveillance (PMS) is to gain information about safety~     and efficacy in real practice.~   "
195970|NCT00998244|"~     The purpose of this research study is to learn if a very low carbohydrate (sugar) diet or~     traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux~     disease (GERD) in people who are overweight. Patients with GERD may experience all or some of~     the following symptoms: stomach acid or partially digested food re-entering the esophagus~     (which is sometimes referred to as heartburn or regurgitation) and belching. In this study,~     the investigators also hope to find out if acid in the esophagus is reduced more by a low~     carbohydrate diet than a low fat diet.~   "
195971|NCT00998231|"~     Major Depressive Episode (MDE) affects nearly 15% of the general population. In a preliminary~     study, the investigators identified 12 genes whose expression was either altered between~     patient and control samples and/or between first patient samples and samples from the same~     patients obtained 8 weeks later. However, this study did not assess evolution of these~     alterations beyond an 8-week window and only 2 time points were considered. The investigators~     aim to compare gene expression difference for 21 candidate genes, of which 12 were already~     investigated, in 2 groups of subjects. MDE and control samples will be analyzed across a~     large time window to draw a better picture of the complex progression during MDE.~   "
195972|NCT00998218|"~     The purpose this investigation is to more thoroughly investigate the effects of ranolazine on~     arrhythmias and microvolt t-wave alternans in patients who have an automatic implantable~     cardioverter defibrillator (AICD) implanted either prophylactically to prevent sudden cardiac~     death, as well as in patients who may have had a clinically significant arrhythmic event~     prompting the insertion of the automatic implantable cardioverter defibrillator. It is~     anticipated this study will provide valuable new insight into the potential use of ranolazine~     to treat arrhythmias in higher risk patients.~   "
195973|NCT00998205|"~     The heart becoming stiff due to increased fibrous tissue or decreased elasticity of the~     heart tissue is one of the earliest changes caused by heart failure. These changes can be~     detected by simple non-invasive echocardiogram techniques. However, these techniques usually~     detect the increased stiffness of the heart only after it has progressed to a significant~     extent. The investigators hypothesize that if they stress the heart using a Dobutamine~     infusion and measure the filling pressure using echocardiogram, it will provide them with~     tools to identify these changes earlier.~   "
195974|NCT00998192|"~     The purpose of this Phase 2 study is to investigate whether intravenous administration of~     REOLYSIN therapeutic reovirus in combination with paclitaxel and carboplatin is effective and~     safe in the treatment of squamous cell carinoma of the lung.~   "
195975|NCT00998179|"~     This study aims to investigate the effect of Acu-TENS on forced expiratory volume in one~     second (FEV1), a test of pulmonary function used to assess airway resistance, during~     sub-maximal treadmill exercise in healthy subjects.~   "
195976|NCT00998166|"~     In the past, patients with advanced lung cancer who were inoperable underwent chemotherapy~     with one or more chemotherapeutic agents. More recently, novel new agents targeting specific~     enzymes or pathways responsible for cell division have been developed and clinicians have~     begun to utilize various combinations of these drugs with standard chemotherapeutic agents~     for the treatment of NSCLC. Some of these approaches have demonstrated a small but~     significant increase in survival among patients with advanced disease. Because a recently~     completed Phase 3 study of bevacizumab + Taxol/Carboplatin in first line NSCLC therapy~     demonstrated a 23% improvement in median survival, it would be appealing to see if a regimen~     of bevacizumab/ cisplatin/Alimta would also demonstrate a similar, or perhaps better,~     response rate.~   "
195986|NCT00998036|"~     This is a Phase I research study designed to determine the maximum tolerated dose (MTD) of~     cisplatin, temsirolimus, and erlotinib in combination for treatment in triple negative breast~     cancer (TNBC) patients.~   "
195977|NCT00998153|"~     The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which~     integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors~     in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually~     assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors~     and revictimization. The principal purpose of this research proposal is to evaluate the~     efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and~     revictimization among adolescents who have been sexually assaulted. The Research Plan will be~     conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program~     as described in Rounsaville, Carroll, & Onken (2001). The final phase of the research will~     involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents,~     comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in~     the community. Participants will be adolescents (12-17 years) who have experienced a sexual~     assault. Assessment of substance use and other risk behaviors, trauma-related~     psychopathology, and incidents of revictimization will be collected at pre- and post-~     treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the~     primary method used to test study hypotheses. Development and evaluation of the proposed~     intervention will have significant implications for addressing public health problems in~     adolescent substance abuse and related high risk behaviors.~   "
195978|NCT00998140|"~     Resuscitative efforts have been shown to be unsuccessful in most cases of out-of-hospital~     cardiac arrest (OHCA), and survivors who do recover cardiac function often sustain severe~     hypoxic brain damage. Time to efficacious care is a primary determinant of disability-free~     survival. In the Jerusalem district, only 9% of OHCA patients present with ventricular~     tachycardia/ventricular fibrillation (VT/VF) as the primary rhythm, whereas 77% present with~     asystole; this seems primarily to be the result of long collapse-to-arrival times.~     Nevertheless, overly zealous resuscitation is undertaken in a high proportion of arrests with~     a futile prognosis, leading to excessive costs.~      Study hypotheses:~        1. Subpopulations for whom intervention is futile/counter-productive are identifiable~        2. Substantial waste of resources can be avoided~        3. Optimization of emergency medical services (EMS) reorganization without adding resources~          is an achievable goal~   "
195979|NCT00998127|"~     The purpose of this observational research study is to determine when and why patients~     discontinue, interrupt, or disrupt the regimen of anti-platelet medications prescribed~     following stent implantation, and to examine the relationship between specific patterns of~     non-adherence and patient outcomes.~   "
195980|NCT00998114|"~     The project aims to investigate the effect of a regular exercise for 6 months on diastolic~     parameters in patients who present with shortness of breath and who have evidence of early~     diastolic dysfunction on echocardiography. Patients will be enrolled from the VA General~     Medicine and Cardiology Clinics, and will be screened for diastolic dysfunction. Once~     enrolled, they will be on an exercise regimen that involves aerobic exercise for 30-45~     minutes five times a week at home. The participants will have an initial supervised exercise~     session with the VA Cardiac Rehabilitation team, and will have either every other week or~     monthly supervised sessions at the VA Cardiac Rehabilitation Center to monitor their~     progress. Clinical, biometric, laboratory and echocardiographic parameters will be obtained~     before and after the 6 month period.~   "
195981|NCT00998101|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as cetuximab, can block cancer growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry cancer-killing substances to them. Giving chemotherapy together with~     monoclonal antibodies may be a better way to block cancer growth.~      PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and~     ixabepilone together with cetuximab works in treating patients with stage III or stage IV~     non-small cell lung cancer previously untreated with chemotherapy.~   "
195982|NCT00998088|"~     Aim: to investigate whether the use of several transfusion alternatives (erythropoietin, the~     cell-saver or postoperative drainage and reinfusion systems) in patients undergoing elective~     total knee or hip replacement surgery can lead to allogeneic red blood cell (RBC) saving if a~     restrictive transfusion policy is used.~      Study design: a prospective, double randomized, open, multicenter study in which patients are~     stratified according to their preoperative hemoglobin(Hb) level: stratum I= Hb between 6,1~     and 8,2 mmol/l. These patients are first randomized for Erythropoetin (Epo) or no Epo.~      Stratum II= Hb of 6,1 and lower or 8,2 mmol/l and higher, are not eligible for Epo and thus~     not randomized. Patients in both strata will be randomized for three modalities: a cell saver~     (CS)(to wash, filter and reinfuse autologous shed blood) which is used intra- and~     postoperatively or a postoperative autologous reinfusion drainage system (D) only (to filter~     and reinfuse autologous shed blood) or a restrictive transfusion trigger only (controls).~      Inclusion criteria: All orthopedic patients of 18 years and older being considered for a~     primary or revision total knee- (TKR) or total hip replacement (THR).~      Outcome measures:~      Primary outcome: number of allogeneic red blood cell (RBC) transfusions.~      Secondary outcome: transfusion reactions, rehabilitation time, length of hospital stay~     (days), peri- and post-operative complications during hospitalization, quality of life, cost~     analysis~   "
195983|NCT00998075|"~     The purpose of this study is to investigate whether treatment with a combination capsule of~     Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within~     the body) as these medications taken separately. Two different forms of esomeprazole (tablets~     and capsules) will be investigated.~   "
195984|NCT00998062|"~     The present project is aimed at determining the prevalence of LDL-C <130 mg/dl with hsCRP~     ≥2mg/l, and of HDL-C < 40 mg/dl in Spain together with the estimation of cardiovascular risk,~     to analyze the contribution of measuring hsCRP for primary prevention purposes. In a subgroup~     of that population a number of inflammatory and oxidative status biomarkers would be also~     measured to better understand the meaning of elevated hsCRP.The study aim to analyze data~     already collected in studies (11 studies will participate) carried out in Spain, in 10~     Spanish regions, after the year 2000.~   "
196132|NCT00996138|"~     This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule~     (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults~     based on EMEA/CHMP criteria, and safety & tolerability.~   "
195988|NCT00998010|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as temozolomide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving bortezomib together with temozolomide and radiation~     therapy may kill more tumor cells and allow doctors to save the part of the body where the~     cancer started.~      PURPOSE: This phase II trial is studying the side effects and how well bortezomib works when~     given together with temozolomide and regional radiation therapy in treating patients with~     newly diagnosed glioblastoma multiforme or gliosarcoma.~   "
195989|NCT00997997|"~     This international, prospective, non-interventional, non-controlled observational study~     obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life~     treatment conditions. Specifically investigated are the improvement of clinical symptoms and~     the duration until infection improvement and cure.Any patient with a diagnosis of complicated~     skin and skin structure infection (cSSSI) treated with Avelox can be documented. The~     observation period for each subject covers the treatment period with Avelox. For each~     patient, the physician documents data at an initial visit and one or two follow-up visit(s)~     in line with routine practice.~   "
195990|NCT00997984|"~     The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1,~     2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children~     with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.~   "
195991|NCT00997971|"~     The purpose of this study is to assess growth and global tolerance in healthy new born~     infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental~     partially hydrolyzed rice protein infant formula.~   "
195992|NCT00997958|"~     Mycophenolate Mofetil (CellCept) is an FDA approved, well tolerated, oral medication used to~     prevent the body's immune system from attacking transplanted organs. It has never been~     studied in patients with pancreatic cancer but some preliminary studies have shown that it~     may antagonize tumor growth. The goals of this study are to find out how much of this drug~     can safely be taken by patients with advanced pancreatic cancer and to assess the variation~     of the level of the drug in the blood. Patients will take the drug twice a day at a given~     dose and the safety of the drug will be monitored through patient symptoms and blood tests.~     The disease burden will be assessed by radiographic studies at the beginning and end of the~     study. The patient will take the drug for a total of eight weeks.~   "
195993|NCT00997945|"~     The purpose of this study is to assess the pharmacokinetics of single and multiple doses of~     10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies.~   "
195994|NCT00997932|"~     This is a prospective clinical trial of ultrasound guided intrauterine contraception~     insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month~     follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.~      The objective of this study is to measure intrauterine device (IUD) expulsion and the~     feasibility of conducting a future clinical trial to evaluate placement of the~     levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.~   "
195995|NCT00997919|"~     This Phase I, single-dose, randomized, parallel-group, open-label study will evaluate the~     safety, tolerability, and pharmacokinetics of MABT5102A following subcutaneous (SC) and~     intravenous (IV) administration in healthy volunteers.~   "
195996|NCT00997906|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine hydrochloride,~     carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy my kill more~     tumor cells. It is not yet known whether giving cisplatin together with radiation therapy is~     more effective with or without gemcitabine hydrochloride, carboplatin, and paclitaxel in~     treating patients with nasopharyngeal cancer.~      PURPOSE: This randomized phase II/III trial is studying how well giving cisplatin together~     with radiation therapy works compared with giving cisplatin and radiation therapy together~     with gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with locally~     advanced nasopharyngeal cancer.~   "
195997|NCT00997893|"~     The purpose of this study is to examine the effects of soy (NovaSoy®) and estrogen on~     menopausal symptoms such as hot flashes, sleep disturbances, and mood alteration in~     perimenopausal women.~   "
195998|NCT00997880|"~     The purpose of this study is to evaluate the effect of statin therapy on the modification of~     atherosclerotic plaque composition and vulnerability in non-intervened coronary arteries with~     mild to moderate stenosis using VH-IVUS and OCT.~   "
195999|NCT00997867|"~     This is a research study to determine if the effects of continuous peripheral nerve blocks~     are influenced by the distance of insertion past the needle tip of the perineural catheter.~   "
196000|NCT00997854|"~     Doctors have tried many different methods of feeding to try to decrease feeding intolerance~     in preterm babies so that they spend less time receiving liquid nutrition and have fewer~     problems with feeding intolerance.~      The purpose of this study is to test two different methods of feeding preterm babies in the~     hopes of identifying a method that will decrease some of the feeding intolerance that can~     occur when feeding premature babies.~   "
196001|NCT00997841|"~     The purpose of the study is to determine the efficacy of two different algorithms for~     coagulation management in patients undergoing cardiac surgery suffering from increased~     bleeding tendency. Algorithm 1 is based on conventional coagulation analyses (INR, aPTT,~     platelet count, fibrinogen concentration,...) and Algorithm 2 is based on thrombelastometry~     using the ROTEM-device and impedance aggregometry using the Multiplate device.~   "
196002|NCT00997828|"~     The purpose of this study is to determine whether the safety and efficacy of coronary stent~     implantation using Everolimus-Eluting Coronary Stent System (Abbott, Boston Scientific) is~     not inferior to coronary artery bypass grafting (CABG) for the treatment of patient with~     multivessel coronary artery disease (CAD).~   "
196064|NCT00997022|"~     This Phase I study of sorafenib in high risk hepatocellular cancer patients after liver~     transplantation will study 24 subjects for about 5 years. Each subject will receive sorafenib~     for 6 months. Safety and effectiveness on the post transplant, high risk HCC patients will be~     studied.~   "
196003|NCT00997815|"~     The main purpose of this study is to determine the efficacy of intralesional botulinum toxin~     type A injection for recalcitrant alopecia totalis and alopecia universalis.~      Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for~     medical practice.The application of diphenylcyclopropenone (DPCP) is still being an standard~     treatment for the condition, however, there are at least thirty percentage of patients~     recalcitrant to this treatment.~      The complete etiology of this disease has yet to be clear.Nevertheless,recent studies have~     demonstrated the hypothesis of neurotransmitter involvements.~      There is numerous evidence in support of an imbalance of transmitters, including substance P~     and Calcitonin gene-related peptide.~      Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused~     alopecia areata. Both headache and hair loss have been made much in improvement. This data~     may support the neurotransmitter imbalance theory.~      The investigators have been informed about possible effects to the alopecia condition,~     therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel~     treatment for recalcitrant alopecia totalis and alopecia universalis.~   "
196004|NCT00997802|"~     The purpose of this study is to evaluate the sensitivity of computed tomographic colonography~     (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of~     colorectal cancer (CRC), using optical colonoscopy as the reference standard.~   "
196005|NCT00997789|"~     The aims of this study were to evaluate the pharmacokinetic properties and bioequivalence of~     two rebamipide preparations in healthy Korean male volunteers for generic substitution and to~     evaluate the association between the genetic polymorphisms in ABCB1 gene (exon 21 and 26) and~     rebamipide disposition.~   "
196006|NCT00997776|"~     The purpose of this trial was to examine the effectiveness of a short-term leg strengthening~     exercise program compared to attention control on improving leg strength, walking speed and~     endurance, physical performance, and physical function one year after hip fracture.~   "
196007|NCT00997763|"~     The purpose of this study is to establish the safety and effectiveness of coronary stenting~     with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment~     of de novo coronary stenosis in patients with diabetic patients.~   "
196008|NCT00997750|"~     The purpose of this study is to determine whether nonsteroidal antiinflammatory drug~     lornoxicam in combination with low dose aspirin (100mg/day) is effective and safe in patients~     with Acute Coronary Syndrome without persistent ST-segment elevation.~   "
196009|NCT00997737|"~     The objective of the present study is to evaluate diaphragm activity during three breathing~     exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and~     volume-oriented (Voldyne) incentive spirometry.~      Seventeen healthy subjects will be studied (8 man and 9 woman).~   "
196010|NCT00997724|"~     The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted~     thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell~     lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If~     success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures~     for non-small cell lung cancer.~   "
196011|NCT00997711|"~     The purpose of this study is to evaluate the safety and performance of the CYPHER SELECT™+~     Sirolimus-eluting Stent (SES) in Asian diabetic patients.~   "
196012|NCT00997698|"~     This is a prospective observational registry with intent to detect the prevalence of~     intracranial aneurysms with contrast-enhanced MR angiography (CE-MRA) at 1.5T, and to~     determine the risk factors such as high blood pressure and cigarette smoking relating to~     intracranial aneurysms.~   "
196013|NCT00997685|"~     This is a single arm, open-label phase II study to evaluate the efficacy and safety of~     Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with~     potentially resectable liver metastasis from colorectal cancer.~   "
196014|NCT00997672|"~     The purpose of this study is to determine safety and tolerability of the treatment with~     lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of~     life and depressive symptoms, will be considered to further investigate the effect of lithium~     therapy.~   "
196015|NCT00997659|"~     This research is to investigate the nutritional supplement chromium picolinate. A large~     number of people use chromium picolinate from health food stores to improve the function of~     the hormone insulin. The investigators are testing how effective this supplement is and are~     also monitoring its safety. In patients with diabetes, chromium has been shown to increase~     sensitivity to the hormone insulin. Since obesity can cause insensitivity or resistance to~     insulin, the investigators are studying obese individuals with documented insulin resistance.~     The investigators would like to know if chromium is also effective in treating the insulin~     resistance associated with obesity.~   "
196016|NCT00997646|"~     To realize performance of a new system - hospitalist-run ward in Taiwan.~   "
196017|NCT00997633|"~     SPECT was performed in 51 patients after cytoreductive surgery in combination with~     intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent~     sequential postoperative intraperitoneal chemotherapy courses that could be performed without~     further surgical intervention. SPECT data was found to predict feasibility of sequential~     postoperative intraperitoneal chemotherapy.~   "
196018|NCT00997620|"~     The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed~     thinking because of the hay fever will improve when treated with an effective anti-hay fever~     medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate~     better thinking.~   "
196019|NCT00997607|"~     This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if~     they are safe, if they have side effects, and if they create an immune response in people who~     receive them.~   "
196020|NCT00997594|"~     The purpose of this study is to evaluate changes in adrenal hormones during adrenal~     radiofrequency (RF) ablation.~   "
196034|NCT00997412|"~     This is an randomized, double-blind, double-dummy trial, and the objective is to compare the~     efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive~     drugs, in myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis~     (MG) patients who are poor controlled under prior steroid therapy. All subjects should be~     randomly assigned to MA group and AZA group that will receive routine pyridostigmine and~     prednisolone in combination with MA or AZA.~   "
196021|NCT00997581|"~     The purpose of the study is to learn about a possible new medicine, apremilast, for treating~     acute gout and compare how it works to indomethacin, a medication that has been used to treat~     gout for over 50 years.~      In order to learn about apremilast, half the participants in this study will receive~     apremilast and half the participants in this study will receive indomethacin.~      This study will measure the severity and duration of acute gout attacks in research~     participants, as well as measures of quality of life and any side effects or adverse~     reactions to the medication.~      There will be three study visits: a screening/baseline visit on Day 1, a visit to evaluate~     response to treatment with study medication at Day 7, and a follow-up visit at Day 21.~   "
196022|NCT00997568|"~     The purpose of this study is to demonstrate the safety of the redesigned transesophageal~     echocardiogram (TEE) transducer as it is inserted and transitioned into the esophagus through~     the mouth.~   "
196023|NCT00997555|"~     The investigators hypothesize that the scheduled use of bronchoscopy on a regular basis after~     inhalation injury in burn patients will improve outcome by providing pulmonary hygiene,~     decrease the incidence of pneumonia, and detect pneumonia earlier than standard treatment~     without bronchoscopy.~   "
196024|NCT00997542|"~     The purpose of this study is to discover whether the inhibition of the xanthine oxidase with~     allopurinol leads to a reduction of the production of oxygen free radicals in patients with~     CHF and thereby improves characteristics of oxydative metabolism, peripheral blood flow,~     immune function and functional status.~   "
196025|NCT00997529|"~     A major focus of recent research has been the development of effective ways of sensitizing~     the patient's immune system to recognize the cancer as foreign. Allogeneic stem cell~     transplantation represents a novel way of potentially achieving this goal. There is recent~     evidence that non-myeloablative allogeneic stem cell transplantation provides effective~     therapy for patients with metastatic renal cell carcinoma. Based on the preliminary reports~     from other investigators treating patient with breast and ovarian cancer, the investigators~     of this study would propose treating an expanded cohort of patients with any metastatic solid~     tumor.~      The principal endpoints of the trial will include incidence of durable engraftment, quality~     of hematopoietic and immune reconstitution, extent of donor chimerism, incidence and severity~     of acute and chronic graft versus host disease (GVHD), and incidence of long-term disease~     free survival (DFS). The investigators will evaluate the tumor response of patients with~     stable or progressive disease post-transplant to donor lymphocyte infusions (DLI). The~     investigators will also study the effects of DLI on T-cell immunity in the recipients.~   "
196026|NCT00997516|"~     Recent advances in laparoscopic instrumentation have made it possible to perform~     intra-abdominal operations entirely through a small incision that can be hidden within the~     umbilicus. The goal is to perform surgery with fewer incisions and no visible scars. Other~     potential benefits are faster recovery, less pain, and fewer wound complications. The term~     SILS (Single Incision Laparoscopic Surgery) is being used to describe such techniques, and~     many have touted SILS as a major breakthrough in minimally-invasive surgery, moving the field~     closer to surgery that is bloodless, incisionless, and painless. Despite the hype,~     prospective comparisons of SILS versus conventional laparoscopy are lacking. Results of SILS~     procedures have generally been limited to case reports and small case series that lack~     controls. The investigators propose to conduct a prospective, randomized, single-center trial~     of SILS appendectomy versus conventional laparoscopic appendectomy to treat acute~     appendicitis. Primary end-points are operative time, complication rate, postoperative pain,~     recovery time, and long-term cosmetic outcome. The investigators hypothesize SILS~     appendectomy is equivalent to laparoscopic appendectomy with respect to operative time,~     complication rate, postoperative pain, and recovery time while providing a better cosmetic~     outcome.~   "
196027|NCT00997503|"~     The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study~     designed to collect real-world safety and clinical outcomes in approximately 4,200 patients~     receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual~     antiplatelet therapy (DAPT) drug regimen.~      This study will also contribute patient data to an FDA-requested and industry-sponsored~     research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT~     Study).~   "
196028|NCT00997490|"~     The efficacy and tolerability of Neurapas® balance was compared against placebo in this~     single-centre, controlled, double-blind study in patients with a mild depressive episode.~      After a one-week placebo run-in phase to exclude placebo responders, patients were given the~     study medication (Neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily.~      The improvement in symptoms of depression was assessed on the basis of the internationally~     established Hamilton Depression Scale 21. The Self-Rating Depression Scale (SDS), the~     Hamilton Anxiety Scale (HAM-A), the Clinical Global Impressions (CGI), Quality of Life~     questionnaire (SF-36) according to Bullinger (German version) and a Sleep questionnaire (SQ)~     were used as further efficacy criteria.~   "
196029|NCT00997477|"~     This study will evaluate the correct use of sequential formoterol and budesonide inhaler~     capsule treatment via Aerolizer and patient satisfaction in adult asthmatics.~   "
196030|NCT00997464|"~     Study of the factors that affect interest in - and uptake of - genetic testing for variants~     that predispose to prostate cancer from the perspective of the patient.~   "
196031|NCT00997451|"~     This study will evaluate, in a primary care setting, the effectiveness of a brief~     self-management behavioral treatment in patients with medically unexplained chronic fatigue.~     The hypothesis will be tested that fatigue self-management will yield improvements in~     fatigue,functioning, and distress in comparison to the two control conditions: standard~     medical care alone or standard medical care plus an attention control symptom monitoring~     condition.~   "
196032|NCT00997438|"~     The purpose of this study is to learn about how the antioxidant, lipoic acid, works in the~     body and how it may help in the management of relapsing remitting and secondary progressive~     multiple sclerosis. This study will compare how subject's and healthy volunteers bodies~     absorb and break down the supplement. This information may help in developing new therapies.~   "
196033|NCT00997425|"~     Main hypothesis. Floor and door visual exit barriers will decrease exit-seeking wandering~     (exit door approaches) proximal to exit doorways by persons with dementia who wander.~   "
196035|NCT00997399|"~     Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel~     cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC~     inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients~     with solid tumors and hematological malignancies.~      To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with~     solid tumors and hematological malignancies participating in several phase I/II clinical~     studies. Panobinostat PK does not appear to be different in patients with solid tumors and~     hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is~     yet to be elucidated.~      Kidney and liver are involved in the elimination and metabolism of panobinostat. The current~     study is designed to evaluate the impact of renal function status on panobinostat PK.~   "
196036|NCT00997386|"~     The purpose of this study is to look at whether the combination of lower-dose chemotherapy~     with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody~     medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so~     that those cells take hold and build a healthy new blood cell factory after transplant. The~     study will also look at the safety of the combination of drugs and of the transplant of~     peripheral blood stem cells from a healthy relative or an unrelated donor.~   "
196037|NCT00997373|"~     Some cases of endometrial cancer are dependent on estrogen for their growth. Letrozole blocks~     estrogen production in the body. The purpose of this study is to determine if the~     investigators can predict which patients might benefit from Letrozole treatment by studying~     the many different forms of the estrogen receptor molecule that exist within the cancer~     tissues. To participate in this study, the patients must be 40 years of age or older and have~     biopsy-proven endometrial carcinoma, either well differentiated or moderately differentiated~     forms. Also, to be eligible to participate in this study, the patients need to be healthy~     enough to have a hysterectomy. If the patients are less than age 60, they will need a blood~     test (FSH) to confirm that they have gone into menopause.~   "
196038|NCT00997360|"~     This is an open label dose escalation study to find the maximum tolerated dose (MTD) of~     PKI-179 in subjects with solid tumors. Part 1 of the study will be the dose estimation phase~     and will be open to subjects with all solid tumors. Part 2 will be the dose confirmation~     phase and will be open to subjects with breast, non small cell lung, ovarian, endometrial, or~     colorectal cancer or glioblastoma. All subjects will receive daily oral dosing of PKI-179. A~     continuous reassessment method (CRM) design will be used, which will take into account dose~     limiting toxicity (DLT) information from each dose level explored in order to determine the~     next dose level.~   "
196039|NCT00997347|"~     This open-label, comparative study will compare the efficacy, safety, and acceptability of~     200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual~     misoprostol for termination of pregnancy in existing outpatient early medical abortion~     services among women 57-63 days' versus 64-70 days' gestation.~   "
196040|NCT00997334|"~     Erlotinib is a drug which targets non small cell lung cancer with a genetic change (mutation)~     in the epidermal growth factor receptor (EGFR). This drug has been used in other cancer~     research studies and information from those studies suggests that Erlotinib can control the~     growth of these cancer cells.~   "
196041|NCT00997321|"~     This study is a clinical trial of moderate sedation with propofol versus moderate sedation~     with ketamine for procedural sedation in the Emergency Department.~   "
196042|NCT00997308|"~     This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two~     doses of AZD1446 or placebo in subjects when given for 4 weeks.~   "
196043|NCT00997295|"~     The aim of the present study was to measure the inspired gas temperature and humidity of the~     anesthetic circuit in the Dräger Primus machine and esophageal temperature with or without~     and heat and moisture exchanger (HME) and low-flow gas during anesthesia in patients~     submitted to gynecological surgeries.~   "
196044|NCT00997282|"~     The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262~     (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a~     double-blind fashion and to evaluate the safety of OPC-262 to placebo.~   "
196045|NCT00997269|"~     This study will investigate whether a supplement called co-enzyme Q10 can help ease or~     eliminate some of the side effects that result from taking statin medications. These side~     effects include muscle pain, fatigue or muscle cramping.~   "
196046|NCT00997256|"~     To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and~     valerian on sleep structure, improvement of attention, and well-being in comparison to~     placebo.~   "
196047|NCT00997243|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as lintuzumab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal~     antibodies may be a better way to block cancer growth.~      PURPOSE: This phase II trial is studying the side effects and how well giving azacitidine~     together with lintuzumab works in treating patients with previously untreated myelodysplastic~     syndromes.~   "
196048|NCT00997230|"~     The primary objective of the study is to collect epidemiological data on EGFR mutation status~     (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation~     status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc).~     In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in~     patients with clinico-pathological characteristics that are not commonly associated with EGFR~     mutation positivity (i.e., smokers, men, and non-adenocarcinoma).~   "
196062|NCT00997048|"~     A pilonidal sinus is a cyst or abscess near or on the natal cleft of the buttocks that often~     contains hair and skin debris. The condition is common and requires surgery to be cured.~     Several surgical procedures are described in literature. The most common surgical procedure~     in Sweden is excision of the sinus followed by suturing the subcutaneous tissue and skin.~     This method, however, has some problems regarding healing and recidives. Therefore this study~     is comparing the standard excision procedure to another surgical procedure, laying open.~     Healing frequency is the main variable, but postoperative pain, sick leave time and patient~     satisfaction is also measured.~   "
196049|NCT00997217|"~     Perioperative myocardial injury is a serious complication of cardiac surgery. This~     complication increases both mortality and morbidity of cardiac surgery. Remote ischemic~     preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ~     can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical~     trials showed powerful myocardial protective effect of remote ischemic preconditioning by~     reducing postoperative cardiac enzymes. However, the evidence that remote ischemic~     preconditioning can improve the clinical outcomes such as mortality and morbidity, is still~     lacking. The investigators perform a multicenter randomized controlled study to evaluate that~     remote ischemic preconditioning can improve the outcomes of cardiac surgery.~   "
196050|NCT00997204|"~     This study is being conducted to explore the clinical safety, local tolerability, convenience~     and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous~     injections of icatibant.~   "
196051|NCT00997191|"~     Intravitreal triamcinolone has been effective for central macular thickness reduction and~     concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is~     a very effective inducer of permeability, being 50.000 times more potent than histamine, and~     may exert its effect on retinal vascular permeability by altering tight-junctions proteins,~     such as occluding and VE-cadherin. Based on these principles, there is a rationale for~     anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as~     diabetic macular edema. Therefore, the purpose of this study is to evaluate the effects of~     intravitreal bevacizumab and intravitreal triamcinolone associated to laser photocoagulation~     for diabetic macular edema.~   "
196052|NCT00997178|"~     The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and~     root planing and supportive periodontal therapy) is efficacious compared to delayed therapy~     in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in~     subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis.~      The secondary aims of the study are to:~        1. evaluate whether 6 month (or shorter-term (3 month)) changes in clinical measures of~          chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical~          attachment level) are related to changes in HbA1c and fasting glucose or insulin~          resistance as measured by the Homeostasis Model Assessment 2 (HOMA2).~        2. assess the 3 month and 6 month efficacy of periodontal therapy on all of the above study~          outcomes. If a treatment response is observed for any of the study outcomes at 3 months,~          then the trial can evaluate whether this response is sustained at 6 months.~   "
196053|NCT00997165|"~     The NUMEVOX cohort is intended to follow-up the macro and microvascular dysfunction in~     relation to adipose tissue repartition in patients with metabolic syndrome associated to~     liver steatosis, sleep apnea. Duration of the follow-up is 3 years for each patient entering~     the cohort.~   "
196054|NCT00997152|"~     The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the~     safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.~   "
196055|NCT00997139|"~     Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in~     about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils~     twice daily for 5 days is the current standard of care for treatment to clear this bacteria.~     This research study is designed to determine the rate of clearance of this bacteria in~     healthcare workers who are carriers when using triple antibiotic ointment instead of~     mupirocin ointment.~   "
196056|NCT00997126|"~     This is a clinical trial of propofol and alfentanil as agents for moderated procedural~     sedation in patients undergoing sedation in the emergency department (ED).~   "
196057|NCT00997113|"~     This is a randomized clinical trial of deep procedural sedation with propofol with and~     without supplemental alfentanil. Patients will be assessed for total and fractionated serum~     catecholamines before and after the procedure in addition to usual procedural sedation~     outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental~     opioid.~   "
196058|NCT00997100|"~     This is an exploratory open label single arm study to evaluate changes in disease activity~     and biomarkers in patients with mild active SLE, during treatment with ABR-215757 given as~     add-on to standard therapy. To be eligible for the study SLE patients should present with~     symptoms from skin, mouth and/or joints. After a screening period of one week patients will~     be treated with ABR-215757 for 12 weeks. The initial dose of ABR-215757 will be 1.5 mg/day.~     There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment.~     Follow-up visits will take place 4 weeks and 8 weeks after last day of treatment. Disease~     activity during treatment will be studied using the Systemic Lupus Erythematosus disease~     Activity Index (SLEDAI-2K) as well as organ system specific disease activity indexes (CLASI~     for skin involvement and number of swollen/tender joints using 28- and 66/68-joint counts).~     At specified time points during the study, blood samples and biopsies will be collected for~     analysis of established and exploratory biomarkers of SLE. Concomitant SLE treatment allowed~     include: prednisolone or equivalent at a dose of ≤15 mg/day, hydroxychloroquine,~     azathioprine, methotrexate and mycophenolate mofetil, all at stable doses from specified~     timepoints prior to the study and throughout the study.~   "
196059|NCT00997087|"~     The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient~     treatment of Obsessive Compulsive Disorder (OCD).~   "
196060|NCT00997074|"~     In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo~     for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks,~     in regard to the effect on pain relief and the overall procedure success.~      expected results:~      The prophylactic use of NSAIDs could offer significant pain relief and thereby a reduction in~     the need for additional pain relievers compared to the placebo, without interfering with the~     outcome of medical abortion~   "
196061|NCT00997061|"~     The registry is an international, multicenter, observational registry of newly diagnosed~     patients with SCLC.~      Data will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan~     remains the responsibility of the patient's physician and data collected in this registry~     will reflect a real world approach of the diagnosis and treatment of patients with SCLC.~      Approximately 60 centres in 13 countries will take part in this registry. It is expected that~     about 500 patients will be recruited during a period of 6 to 9 months according to the~     feasibility.~   "
196066|NCT00996996|"~     This is a single-arm, single-institution, phase II study of Iodine-131 Anti-B1 Antibody for~     patients with previously untreated, advanced-stage (stage III or IV) low-grade non-Hodgkin's~     B-cell lymphoma. A total of 75-80 patients will be enrolled.~      Patients will undergo two phases of the study. In the first phase, termed the dosimetric~     dose, patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70~     minutes (including a 10-minute flush) immediately followed by a 30-minute infusion (including~     a 10-minute flush) of Anti-B1 Antibody (35 mg) which has been trace-labeled with 5 mCi of~     Iodine-131. Whole body gamma camera scans will be obtained 5 to 8 times between Days 0 and 7~     following the dosimetric dose. Using the dosimetric data from 3 imaging timepoints (the~     imaging timepoints to be used in decreasing order of preference depending on availability of~     data are Days 0, 3, and 7; Days 0, 4, and 7; Days 0, 3 and 6; Days 0, 4, and 6; Days 0, 2,~     and 7; and Days 0, 2, and 6), a patient-specific dose of Iodine- 131 to deliver the desired~     total body dose of radiotherapy will be calculated. In the second phase, termed the~     therapeutic dose, patients will receive a 70-minute infusion (including a 10-minute flush)~     of unlabeled Anti-B1 Antibody (450 mg) immediately followed by a 30-minute infusion~     (including a 10-minute flush) of Anti-B1 Antibody (35 mg) labeled with the patient-specific~     dose of Iodine-131 to deliver a whole body dose of 75 cGy. Patients who are obese will be~     dosed based upon 137% of their calculated lean body mass. Patients will be treated with~     either saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide~     tablets starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1~     Antibody (i.e., dosimetric dose) and continuing for 14 days following the last infusion of~     Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose).~      The primary endpoint of the study is the determination of the response rate with Iodine-131~     Anti-B1 Antibody in previously untreated patients with low-grade non-Hodgkin's lymphoma~     (NHL). The secondary endpoints include duration of response, safety, radiation dosimetry, and~     the predictive value of detection of the presence or absence minimal residual disease by~     molecular techniques on response duration.~   "
196067|NCT00996983|"~     Neuropathic pain is difficult to control because it is only partially sensitive to opioid~     analgesics, and requires the addition of other therapies such as antidepressants and~     epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have~     had inadequate pain control with prior combination of medicines.~   "
196068|NCT00996970|"~     The purpose of this research is to determine the effectiveness of the novel H1Nl influenza~     (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons.~     The administration of the H1Nl vaccination is not part of the study's procedures, but is~     being given as part of routine care.~   "
196069|NCT00996957|"~     For cancer cells to grow, they need to have nutrients supplied to them through blood vessels.~     The study drug, ACE-041, is designed to work by blocking the growth of those blood vessels~     and preventing cancer cells from growing. The purpose of this study is to establish safe dose~     levels of ACE-041 in patients with advanced solid tumors or relapsed/refractory multiple~     myeloma following multiple dose administration. This study will also evaluate if ACE-041 has~     an effect on tumors.~   "
196070|NCT00996944|"~     This is a multicenter, placebo controlled, parallel group, double-blind, randomized~     comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally~     administered for 12 weeks in patients with symptomatic restless legs syndrome associated with~     Chronic kidney disease (CKD) managed with haemodialysis (including haemofiltration and~     haemodiafiltration) (hereinafter referred to as uRLS), to evaluate the efficacy and safety~     of long-term administration of ropinirole IR tablets, and assess the effect on the steady~     state pharmacokinetics in the long-term administration period of ropinirole IR tablets.~   "
196071|NCT00996931|"~     The purpose of this study is to determine if lenalidomide (Revlimid®)reduces proinflammatory~     cytokines including TNF-alpha and may actually alter the clinical course of autism for some~     children.~   "
196072|NCT00996918|"~     The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab~     in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over~     250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each~     subject's participation will last approximately 4 years.~   "
196073|NCT00996905|"~     Ultrasound scanning of the back has been shown to increase success when used to guide~     epidural catheter insertion. However, this technique is not applied widely in clinical~     practice. Stronger evidence is required to prove that it will improve the clinical experience~     of labour epidurals.~      The study hypothesis is that anesthesiologists (both residents and fellows), will have an~     increased rate of success and ease of insertion of labour epidural catheters, and that there~     will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done~     prior to the procedure.~   "
196074|NCT00996892|"~     This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the~     safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib~     administered in combination in patients with locally advanced or metastatic solid tumors.~   "
196075|NCT00996879|"~     The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of~     the CYP3A4 Probe Midazolam.~   "
196076|NCT00996866|"~     Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies~     were done with non-obese subjects. This study looks at vitamin D supplementation requirements~     in obese patients as compared to non-obese subjects. This study also looks at changes in~     vitamin D level in obese patients undergoing medical weight loss. It is thought that obese~     patients have vitamin D deficiency through storage of vitamin D in the fat compartment not~     readily available for blood measurement. The investigators' hypothesis is that with medical~     weight loss vitamin D levels will increase in obese subjects.~   "
196077|NCT00996853|"~     The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions~     as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid~     generation, communication and evaluation of safety data.~      This study is a commitment to the European Medicines Agency (EMEA), as part of~     GlaxoSmithKline Biologicals' (GSK Biologicals') risk management plan for pandemic influenza~     vaccination.~   "
196078|NCT00996840|"~     This is an early phase (Phase IIa), randomized, double-blind, parallel group, multi-centre~     study for subjects with trauma (physical injury) who are at risk for developing Acute Lung~     Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The primary purpose of the study~     is to evaluate the safety and tolerability of SB-681323, which is a potent, selective~     inhibitor of p38 alpha (MAPK) (prevents inflammation of tissue), in comparison to a placebo.~   "
196079|NCT00996827|"~     This project seeks to understand differences in the serum vitamin D levels and immune status~     in cutaneous malignant melanoma patients with different UV exposure histories in New Mexico.~   "
196092|NCT00996658|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to~     metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with~     insufficient glycaemic control.~   "
196184|NCT00995449|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of~     various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who~     have had an inadequate prior treatment outcome from biologic therapy.~   "
196080|NCT00996814|"~     The primary aim of the study is to demonstrate the value of a preemptive approach to ethics~     consultation in an ICU. The investigators hope to answer the question: Will proactive ethics~     interventions by a skilled and experienced ethicist, participating in treatment discussions~     with physicians and nurses, as well as discussions with patients/surrogates, improve the~     quality of ICU care experienced by patients requiring prolonged treatment in the ICU (5 days~     or longer) by increasing their perceived quality of care and reducing the length of stay in~     the ICU by non-survivors?~      The study is a randomized trial of the use of an ethics consultant to address latent or~     manifest ethical issues in patients who remain in the ICU for five days or more, as compared~     to usual care. The investigators are testing the hypothesis that expanding the role of ethics~     consultations in the ICU to make them proactive will improve the process and outcomes of~     patient care by shortening the length of stay in non-survivors, and reducing suffering and~     unwanted and/or unnecessary aggressive treatments.~   "
196081|NCT00996801|"~     This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be~     achieved by switching to MK-5442 from an oral bisphosphonate in participants who have been~     receiving oral bisphosphonate therapy for at least 3 years.~   "
196082|NCT00996788|"~     To study the anti free radical & inflammatory effect and safety of Rebamipide in patients~     suffering of dyspepsia due to chronic gastritis.~   "
196083|NCT00996775|"~     This research study will examine the effectiveness of a brief, computerized motivational~     intervention plus treatment-as-usual to treatment-as-usual alone for treating alcohol misuse~     in Veterans presenting to primary care. The investigators aim to recruit 162 Veterans~     screening positive on the AUDIT-C to participate in this study. Participants will be randomly~     assigned to one of the two intervention conditions and be asked to complete a baseline~     assessment and two follow-up assessments conducted at three and six months post treatment.~     Baseline assessments will be conducted in person by a trained research assistant, while all~     follow-up interviews will be conducted over the phone. The primary outcome for this clinical~     trial is the reduction in the number of heavy drinking days. Several secondary outcomes will~     be collected including health status, depressive symptoms, consequences of drinking, pain~     symptoms, and distress tolerance. The findings from this study may have large scale~     implications for how alcohol misuse is treated in primary care. In addition, this study will~     provide evidence for the feasibility of using the computer as a method for delivering~     evidence-based mental health interventions in primary care.~   "
196084|NCT00996762|"~     This study will assess alternative formulations of lapatinib for relative bioavailability and~     bioequivalence (BE) with the current commercial formulation (reference). Subjects will be~     dosed for at least one week (7 days) on each formulation and PK samples will be collected~     after each lapatinib formulation dosing Period on Period 1 Day 7 and Period 2 Day7 at~     pre-dose and up to 24 hrs post dose. The study may evaluate up to three alternative test~     formulations. After subjects complete the PK evaluation at the End of Study Visit, if they~     are eligible, they will have the option to enter EGF111767, an open-label, Phase Ib~     continuation study of lapatinib monotherapy or lapatinib in combination with other~     anti-cancer treatments.~   "
196085|NCT00996749|"~     This phase I trial is studying the best way to give omega-3 fatty acids in treating patients~     with advanced prostate cancer. Omega-3 fatty acids may slow disease progression and may be an~     effective treatment for patients with advanced prostate cancer~   "
196086|NCT00996736|"~     The purpose of this study is to determine if natamycin or voriconazole results in better~     visual outcomes in fungal corneal ulcers, especially visual acuity.~   "
196087|NCT00996723|"~     This is a Phase I clinical trial evaluating the combination of vandetanib and dasatinib~     during and after radiation therapy (RT) in children with newly diagnosed diffuse intrinsic~     pontine glioma (DIPG).~   "
196088|NCT00996710|"~     This study will look for new types of gene changes that may be related to cancer in some~     patients. Some gene changes (mutations) are passed on from parents to offspring (child).~     Other gene changes are new and are seen for the first time in a child. They are not seen in~     the parent.~      Some of these gene changes may cause cancers in the offspring. We will look for gene changes~     by studying patients with cancer their parents and family members without cancer. In this~     study, we will be able to find gene changes that occur in the cancer patient but not in the~     rest of the family. Knowing the role that new gene changes play in cancer risk may help us~     find people at a higher risk of getting cancer.~   "
196089|NCT00996697|"~     Different medications are often used in combination for the condition COPD (chronic~     obstructive pulmonary disease). Some medicines act by opening the airways (bronchodilators)~     and some act as anti-inflammatories (steroids). More recently an approach of using a~     combination inhaler (containing a steroid and a long-acting bronchodilator) at the same time~     as a long acting bronchodilator of a different group of medicines (anti-cholinergics~     inhalers) has been used. This approach is sometimes called 'triple therapy'. Studies which~     have looked at these combinations usually use only standard blowing tests (spirometry) to~     test these medicines and focus on the effects of the medicines at their highest (peak)~     levels. It is some ways more relevant to study these medicines towards to end of the dose~     period (trough)- just before the next dose. This is when there is less medicine in the~     system, and differences in drug effects are more obvious. There are also more detailed~     breathing tests than spirometry which get a more detailed picture of the way the lungs~     respond to bronchodilator medicines. The investigators have studied 'triple therapy' in COPD,~     by measuring the effects at the end of the dosing interval (trough) using a range of detailed~     respiratory tests.~   "
196090|NCT00996684|"~     The purpose of this study is to determine whether microplasmin given by intravitreal~     injection is effective and safe for the treatment of wet age-related macular degeneration~     (AMD) in patients who have focal vitreomacular adhesion (VMA)~   "
196091|NCT00996671|"~     The purpose of this study is to test the safety of a new drug and to look at how the drug is~     handled by your body. This is the first time the drug will be given to people, the drug has~     been safely given to animals over many days at higher doses than will be given in the study.~     The study will be done in healthy men and woman to determine what effects, good or bad, it~     has on thier health. This study will find out:~      If the drug has any side effects after one dose of the drug is given? How much of the drug~     gets into the bloodstream, and how long does the body take to get rid of it? If the drug~     causes any changes to a substance that is in skin, hair or blood.~   "
196093|NCT00996645|"~     There remains a large gap between ideal and actual care provided to patients with chronic~     diseases. Performance feedback reports are often used as a foundation for quality improvement~     interventions. There have been hundreds of trials investigating the use of feedback reports;~     the important question to ask now is not whether performance feedback reports can help to~     improve quality of care, but how to optimize feedback interventions to accomplish that goal.~     The purpose of this study is to test whether a theory-based intervention added to feedback~     reports sent to primary care providers can result in improved outcomes for patients with~     chronic disease.~   "
196094|NCT00996632|"~     Background: Lymphatic stasis and seroma formation are common complications of axillary~     lymphadenectomy in breast cancer surgery. The investigators aim is to test the hypothesis~     that the use of an ultrasonic knife for axillary dissection reduces the total amount and~     duration of persistent drainage and length of hospital stay. Method: The investigators have~     conducted a randomized trial on 94 patients (1 male, 93 females, mean age 64.7 years) who~     presented to the investigators unit with operable breast carcinoma. Patients in group A (38~     cases) were operated on using exclusively the ultrasonic knife. Patients in group B (56~     cases) were operated on using the conventional diathermy knife.~   "
196095|NCT00996619|"~     Lesions, polyps and other abnormalities in the gastrointestinal (GI) tract have a different~     composition compared to the normal mucose. The investigators plan to gather spectroscopic~     information from these features. Characterizing their unique spectrums, may help to enhance~     the detection and identification of these objects during endoscopy.~   "
196096|NCT00996606|"~     This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in~     combination with DMARDs in participants with moderate to severe active rheumatoid arthritis~     who have an inadequate response to DMARDs. Participants will receive tocilizumab as 8~     milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks in addition to~     their current DMARD therapy.~   "
196097|NCT00996593|"~     This is a single-arm, open-label, multicenter study of Iodine I-131 Anti B1 Antibody~     (Tositumomab and Iodine I 131 Tositumomab) for treatment of non-Hodgkin's lymphoma (NHL) who~     were previously treated with rituximab antibody. Patients must have been treated with at~     least 4 doses of rituximab and have progressed during or following rituximab therapy.~      Patients will undergo two dosing phases of study. In the first phase, termed the dosimetric~     dose, patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70~     minutes immediately followed by a 30-minute infusion of Anti-B1 Antibody (35 mg) which has~     been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained on~     Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Using the dosimetric~     data from three imaging timepoints, a patient-specific dose of Iodine-131 will be calculated~     to deliver the desired total body dose of radiotherapy. In the second phase, termed the~     therapeutic dose, patients will receive a 70-minute infusion of unlabeled Anti-B1 Antibody~     (450 mg) immediately followed by a 30-minute infusion of 35 mg Anti-B1 Antibody labeled with~     a patient-specific dose of Iodine-131 to deliver a whole body dose of 75 cGy to patients with~     no hematologic risk factors. Patients who have platelet counts of 100,001-149,999 cells/mm3~     will receive 65 cGy and patients who are obese will be dosed based upon 137% of their lean~     body mass. Patients will be treated with either saturated solution potassium iodide (SSKI),~     Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first~     infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and continuing for 14~     days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose).~      The endpoints of the study are to determine the response rate, complete response rate,~     duration of response, and time to progression or death, based on both a Masked Independent~     Randomized Radiographic and Oncologic Review (MIRROR) panel and the Investigators, and the~     Investigators' assessment of safety and survival of survival of Iodine-131 Anti-B1 Antibody~     therapy in NHL patients who have previously been treated with rituximab.~   "
196098|NCT00996580|"~     This is an open-label, single-treatment study. All subjects will receive 12 months of oral~     contraceptive therapy with DR-103. Study participants will receive physical and gynecological~     exams, including Pap smear. During the study, all participants will be required to complete a~     diary.~   "
196099|NCT00996567|"~     Multicenter, open phase 2 study on patients with malignant mesothelioma. Standardly, 4 to 6~     cycles of palliative chemotherapy, platinum in combination with pemetrexed, are given.~     Despite of this treatment, median survival is poor (9-12 months). By combining conventional~     cytotoxic agents with a novel agent, hopefully treatment and survival can be approved.~     Cetuximab or Erbitux is a monoclonal antibody against the EGFR (Epidermal Growth Factor~     Receptor). By blocking the receptor, it interferes with cel growth and division. Most~     mesothelioma show a strong expression of the EGFR protein. Apart from that, Cetuximab also~     has antibody-dependent cell-mediated cytotoxicity (ADCC).~      In this trial, patients will be treated with standard chemotherapy, combined with Cetuximab~     weekly. After a maximum of 6 cycles of chemotherapy, administration of Cetuximab will be~     continued until disease progression. Every 6 weeks, a CT scan will be done to evaluate~     therapy. Most common side effect of Cetuximab is acneiform rash.~      The translation research program consists of the determination of EGFR- and K-Ras mutations~     on the tumor tissue and the correlation with outcome.~      In the first part of the trial, 18 patients will be included. After a positive interim~     analysis, a total of 43 patients will be included.~   "
196100|NCT00996554|"~     The purpose of this study is to examine the frequency of postoperative complications~     depending on the number of suture layers in colo-colonic and ileo-colonic anastomoses~     Hypothesis: double-layer suture has less anastomotic leakages compared to single-layer~     suture.~   "
196101|NCT00996541|"~     Runaway and homeless youth are at risk for HIV based upon their rates of substance use,~     particularly injection drug use, unprotected sexual intercourse, multiple partners, and~     sexually transmitted diseases. Risk increases as the time away from home increases. STRIVE is~     a family intervention aimed at increasing residential stability, decreasing runaway episodes,~     and decreasing HIV risk. Families are randomly assigned to a cognitive-behavioral~     skills-building intervention consisting of five weekly sessions delivered at family homes, or~     are assigned to standard care. Sessions are aimed at increasing problem solving, role~     clarity, and positive interactions. It is hypothesized that the intervention will result in~     improved family dynamics, less runaway behavior, and less risky behavior.~   "
196102|NCT00996528|"~     The purpose of this study is to test a mother-to-mother intervention during pregnancy and~     after delivery with mothers in South Africa, most of whom are at risk delivering babies with~     fetal alcohol syndrome, babies that are underweight, or babies that are infected with HIV~     from an HIV-positive mother. The investigators hypothesize that the intervention will reduce~     the chance of these three health outcomes occurring in the babies and improve the health of~     the mother.~   "
196103|NCT00996515|"~     PRIMARY OBJECTIVES:~      I. To document the toxicities, and reversibility of toxicities, of this regimen of~     5-azacytidine (azacitidine) and erlotinib (erlotinib hydrochloride).~      SECONDARY OBJECTIVES:~      I. To determine any potential anti-tumor effects, as determined by the objective tumor~     response (complete and partial responses), clinical benefit (complete and partial responses,~     and clinical benefit), the time to tumor response, the time to tumor progression, and the~     overall survival.~   "
196104|NCT00996502|"~     The primary objectives of this study are to evaluate the safety and best dose of a regimen~     including bevacizumab and erlotinib in combination with docetaxel and prednisone. In~     addition, the investigators wish to evaluate how well these drugs might work against this~     disease. Bevacizumab and erlotinib are novel drugs that attack the blood vessels supplying~     the tumor cells and attack a receptor on the tumor cells, respectively. This study has two~     parts. In the first part of the study, eighteen patients will be enrolled. Patients will~     receive escalating doses of docetaxel in combination with standard doses of bevacizumab and~     erlotinib until the safest dose is determined. An additional 37 patients will enter into the~     second part of the study and all will receive the safest dose. In this part of the study, the~     effectiveness of this regimen against hormone refractory prostate cancer (HRPC) will be~     monitored by evaluating prostate-specific antigen (PSA) and objective response of the tumor.~   "
196105|NCT00996489|"~     This is a post approval study of Coaptite® in the treatment of female urinary incontinence.~   "
196106|NCT00996476|"~     The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores~     what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a~     and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never~     received treatment for their hepatitis C infection.~   "
196107|NCT00996463|"~     The rationales of a clinical trial comparing intralesional antimonial therapy versus wound~     care management in patients with old world cutaneous leishmaniasis (OWCL) are the following:~        1. The effectiveness of the current mainstay treatment with intralesional antimonials for~          CL is subject to discussion, especially in L. major lesions which are predominant in~          Northern Afghanistan~        2. The importance of wound care management in patients with OWCL has been emphasized by~          Gonzalez et al. (2008) and its efficacy is confirmed in the Kabul trial with L. tropica~          patients.~      Parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility~     of the treatment options under study.~   "
196108|NCT00996450|"~     To document pre-diagnosis educational abilities, to document any change in educational~     achievements following treatment, to document educational support given within the statement~     process and to document the timing of support.~   "
196109|NCT00996437|"~     This study is being conducted to determine if intravitreal injections of ranibizumab decrease~     the proportion of eyes in which vitrectomy is performed compared with saline injections in~     eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.~   "
196110|NCT00996424|"~     Inhalation treatment with mucolytics is one of the cornerstones of CF treatment for~     respiratory problems.~      The efficacy of inhalation treatment with recombinant DNAse and hypertonic saline is well~     established. The North American CF foundation reported that there is insufficient evidence~     for or against the chronic use of inhaled N-Acetylcysteine (NAC) to improve lung function and~     reduce exacerbations .~      In vitro tests proved the positive effect of NAC on sputum rheology . Evidence based research~     however on the in vivo effect of NAC on visco-elasticity and lung function is rare. There are~     only three randomized controlled clinical trials on nebulised NAC, none of them showing a~     statistically significant or clinically relevant beneficial effect. Nevertheless at least in~     Europe for many years inhalation treatment with NAC is advised. Because of the disgusting~     sulphur odour, many patients are reluctant to use this inhalation medication.~      We intend to start an open placebo controlled in vivo cross-over study to evaluate the effect~     of Acetyl cysteine compared to normal saline on the sputum visco-elasticity and on the short~     term effect on lung function.~      Sputum producing CF-patients, able to perform lung function tests will be enrolled.~      Sputum viscoelasticity will be measured by a controlled-stress rheometer (AR 1000-N;~     TA-Instruments, Ghent, Belgium) at 20° C, using a cone-plate geometry 8.~      Lung function measurement (FVC, FEV1, FEF 25-75) will be done in a Masterlab body~     plethysmograph (Jaeger®) Sputum samples will be collected before lung function test on a~     regular control visit. Three ml of NAC or 4 ml of normal saline will be inhaled, afterwards a~     second sputum sample will be collected and a control lung function test will be performed.~     Visco-elasticity measurements will be done on sputum samples before and after inhalation of~     NAC or normal saline. Patients will continue to inhale N-acetylcysteine or normal saline two~     times per day for one month. After one month a control lung function and a third sputum~     sample will be collected, visco-elasticity and lung function will be measured and compared to~     the initial values in both groups and between groups. After a wash-out period of normal~     saline inhalations during 2 weeks in both groups, patients in the initial control group will~     be asked to switch to inhalation of 3 ml of NAC two times per day and the former NAC group~     will continue to inhale two times 4 ml of normal saline during four weeks. After one month~     the same measurements of visco-elasticity and lung function tests will be done.~   "
196111|NCT00996411|"~     This study is characterizing the subject-rated and behavioral effects of salvinorin A in~     healthy volunteers. The investigators hypothesize the salvinorin A will have~     hallucinogen-like effects.~   "
196112|NCT00996398|"~     The aim of this project is to assess the effect of cold water immersion on knee joint~     re-positional sense in healthy subjects. Cryotherapy, in the form of cold water immersion,~     had previously been shown to improve athletic performance however, debate exists within the~     existing literature regarding whether proprioception, in the form or joint position sense, is~     effected post treatment.~      Null hypothesis (H0): Water immersion has no effect on joint position sense (JPS).~      Alternate hypothesis (H1): Water immersion has an effect on joint position sense.~   "
196113|NCT00996385|"~     Study chemotherapy will consist of four treatments with Velcade (days 1, 4, 15, and 18) and~     two treatments with Eloxatin(days 4 and 18). Patients will be undergo standard of care blood~     work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans~     performed to assess tumor response every 2 cycles (8 weeks). Each patient will be allowed to~     receive a maximum of 6 cycles of therapy. Following discontinuation of treatment due to~     disease progression or completion of therapy, patient's will be followed for survival, QOL~     assessments, and tumor assessments every 3 months (or as clinically indicated) for the first~     year and every 3 months thereafter for a maximum of 5 years.~   "
196114|NCT00996372|"~     The objective of this trial is to assess the safety and efficacy of 24-week course of~     flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally~     postmenopausal women.~   "
196115|NCT00996359|"~     RATIONALE: Giving low-dose total-body irradiation before a donor stem cell transplant helps~     stop the growth of cancer cells. It also stops the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune cells and help~     destroy any remaining cancer cells (graft-versus-tumor effect).~      PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant after~     total-body irradiation and to see how well it works in treating patients with relapsed or~     refractory hematologic cancer or acute myeloid leukemia or acute lymphocytic leukemia in~     complete remission.~   "
196129|NCT00996177|"~     The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled~     system to deliver fentanyl compared with a patient-controlled intravenous system to deliver~     morphine in the management of postoperative pain.~   "
196130|NCT00996164|"~     The object of this trial is to assess the safety and efficacy of a 24 week course of~     flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.~   "
196116|NCT00996346|"~     Refractory soft tissue sarcoma remains a difficult malignancy to treat. The mammalian target~     of rapamycin (mTOR) is an enzyme that plays an important role in cancer cell survival. mTOR~     inhibitors, like temsirolimus, have shown activity in sarcoma. Irinotecan is a chemotherapy~     drug that has also been used to treat sarcoma. However, it is unknown whether combining these~     two drugs would result in improved efficacy with acceptable toxicity.~      Therefore, the goal of this phase I study is to determine the maximum tolerated dose (MTD)~     and toxicity profile of combination temsirolimus and irinotecan both administered~     intravenously on a weekly basis to refractory soft tissue sarcoma patients.~   "
196117|NCT00996333|"~     This study is designed to determine whether an investigational drug combination consisting of~     Gemzar®, Taxotere®, and Xeloda®, (called GTX) is safe and effective in treating advanced~     pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of~     patients with pancreatic cancer.~   "
196118|NCT00996320|"~     The purpose of this study is to determine whether reducing intern work hours and eliminating~     extended shifts in the intensive care unit will reduce prescribing errors and improve intern~     well-being.~   "
196119|NCT00996307|"~     This study will evaluate the safety and immunogenicity of different combinations of A/H1N1~     2009 (swine flu) vaccine in healthy young children~   "
196120|NCT00996294|"~     Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to~     gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of~     the operations on diabetes control.~   "
196121|NCT00996281|"~     The purpose of this study is to compare the safety and tolerability of azilsartan medoxomil~     plus chlorthalidone, once daily (QD), versus olmesartan medoxomil-hydrochlorothiazide in~     adults with essential hypertension.~   "
196122|NCT00996268|"~     Sixteen healthy subjects will be randomized to each of the 3 parallel treatment groups.~     Eligible subjects will check in to the clinical unit on Day -2 and have 24-hr pharmacokinetic~     collections on Day -1 and on Day 1. Once the pharmacokinetic parameters of the formulations~     have been analyzed, doses of GSK2212836 will be selected for further study in Part B.~     Subjects from Part A will participate in Part B.~      Part B is a single blind, randomized, placebo controlled study that will consist of a 2-week~     repeat dose period with 3 dose levels and one dose of the marketed formulation of GSK2212836.~     Subjects will check in to the clinical unit on Day -3; will participate in a test meal on Day~     -2 and have 24-hr baseline pharmacokinetic profiles on Day -1 and Day 1. Subjects will be~     released from the clinic on Day 2, and return for daily dosing on Days 3 through 12. On Day~     6, they will also have a brief outpatient visit. Subjects will check into the clinic again on~     the evening of Day 12, and on Day 13 they will again have 24-hr pharmacokinetic profiles~     collected. Subjects will be released from the clinical research unit on Day 14, following a~     test meal, triglyceride sampling and check-out assessments, and will be released from the~     study 5-10 days later after completing a follow up visit.~   "
196123|NCT00996255|"~     The purpose of this open-label, multi center, phase I study, was to determine the safety~     profile of PHA-793887 administered by intravenous infusion to patients with~     advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum~     tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.~   "
196124|NCT00996242|"~     The objective of the present study was to investigate the possibility of using L-lysine, an~     amino acid that occurs naturally in food and which interferes with nitric oxide (NO)~     production, for the treatment of schizophrenia. L-lysine, 6 g/day, was administered to ten~     patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment.~     The study was designed as a single-blinded, cross-over study where patients were randomly~     assigned to initial treatment with either L-lysine or placebo and screened at baseline, after~     four weeks when treatment was crossed over, and after eight weeks when treatment was~     terminated. The four-week L-lysine treatment regimen caused a significant increased in blood~     concentration of the amino acid and was tolerated well. The analysis of outcome measures~     showed a significant decrease in symptom severity as measured by the Positive and Negative~     Syndrome Scale (PANSS). Furthermore, the patient's ability to solve the Wisconsin Card~     Sorting Task (WCST) was significantly improved indicating increased problem solving capacity~     and cognitive flexibility. Subjective reports from three of the patients also indicated~     decreased symptom severity and enhanced cognitive functioning. In summary, these findings~     suggest potential beneficial effects of L-lysine treatment on symptom severity and cognitive~     deficits in patients with schizophrenia.~   "
196125|NCT00996229|"~     The researchers will investigate whether caloric restriction or dietary supplementation could~     provide positive effects on general brain functions in healthy elderly people.~   "
196126|NCT00996216|"~     The purpose of this study is to test the safety and tolerability of eltrombopag when used to~     increase and maintain platelet count. Platelet count to be maintained at a level sufficient~     to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions,~     and to avoid permanent discontinuation of antiviral therapy.~   "
196127|NCT00996203|"~     This open-label single arm study will evaluate the efficacy and safety of tocilizumab added~     to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to~     severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will~     receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition~     to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is~     24 weeks, and the target sample size is 200.~   "
196128|NCT00996190|"~     During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low~     blood pressure is the most common side effect of the spinal medication used to anesthetize~     the patient prior to the start of surgery. This low blood pressure can also trigger~     unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.~      Currently there are 2 methods of phenylephrine administration during Cesarean section. One~     method is by intermittent bolus and the other is by continuous infusion. It is ideal to have~     a regimen for phenylephrine administration that maintains blood pressure without compromising~     cardiac output.~      In this study, cardiac output and blood pressure will be measured by transthoracic~     bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.~      The hypothesis of this study is that the continuous infusion of phenylephrine will be equally~     effective in maintaining blood pressure as compared to the intermittent injection, and will~     induce less hemodynamic changes.~   "
196133|NCT00996125|"~     This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline~     Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects~     aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group~     will receive the control.~   "
196134|NCT00996112|"~     The goal of this study is to further the investigators' understanding of community acquired~     methicillin-resistant Staph Aureus (CA-MRSA) and treatment of it by developing real-world~     sustainable strategies consistent with existing guidelines on treatment of CA-MRSA from the~     Centers for Disease Control and Prevention (CDC) and test these strategies in busy primary~     care settings.~   "
196135|NCT00996099|"~     The purpose of this study is to evaluate the safety and efficacy of a system combining~     continuous glucose measurement with a computer-based algorithm for insulin delivery in~     patients undergoing elective cardiac surgery.~   "
196136|NCT00996086|"~     This is an observational study to learn which patients benefit from CRT therapy and to track~     the clinical changes that help identify the risk-level of CRT patients.~   "
196137|NCT00996073|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in~     subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral~     levels between L1 and S1. All subjects in this study will undergo interbody fusion via~     Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF)~     procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior~     instrumentation.~   "
196138|NCT00996060|"~     1. Primary Objective:~           The primary endpoint to this study will be to document the toxicities, and reversibility~          of toxicities, of this regimen of hydralazine and valproic acid in patients with~          advanced, unresectable, previously treated lung cancers, for whom no acceptable standard~          therapy is available. A primary endpoint will be to determine any potential dose~          limiting toxicities, and the Maximal Tolerated Dose of this regimen.~        2. Secondary Objectives:~      The secondary endpoint of this study will be to determine any potential anti-tumor effects,~     as determined by the objective tumor response (complete and partial responses), clinical~     benefit (complete and partial responses, and clinical benefit), the time to tumor response,~     the time to tumor progression, and the overall survival.~   "
196139|NCT00996047|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This research study is looking at bone marrow and blood samples from patients with~     leukemia or other hematopoietic cancers.~   "
196140|NCT00996034|"~     This is a molecular imaging research study designed to examine how much nicotine gets into~     the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi~     Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine~     designed as an aid to smoking cessation and long-term abstinence, as well as an aid to~     prevent relapses of a treated smoker.~      In this project we want to understand the degree to which NicVAX administration changes how~     much nicotine enters the brain in smokers.~   "
196141|NCT00996021|"~     This will be a randomized, partial-blind, placebo-controlled, single dose, cross-over trial~     investigating the effect of GSK1349572 on cardiac repolarization as compared to placebo in~     healthy adult males and females. Approximately 42 subjects will be enrolled in this study and~     will be admitted to the clinic for three separate dosing sessions. Subjects will receive~     single dose administrations of placebo, a supratherapeutic dose of GSK1349572 (250 mg), and~     moxifloxacin (400 mg) in random sequence. Safety of subjects will be monitored by clinical~     observation, measures of vital signs, 12-lead ECGs and clinical laboratory measurements.~   "
196142|NCT00996008|"~     This study will look at how safe and effective, a novel agent, CT 327 cream is in treating~     patients with mild to moderate atopic dermatitis (AD). Patients will be treated twice daily~     for 14 days on specific lesions of AD and safety and symptoms of AD will be assessed~     throughout the treatment period.~   "
196143|NCT00995995|"~     Carry out the cost-effectiveness analysis of rosiglitazone on a population in line with the~     rosiglitazone license and using UK costs~   "
196144|NCT00995982|"~     Background:~        -  Vaccines are substances used to try to create resistance or immunity to a disease and to~          prevent an infection. Investigators are looking into improved ways to give and test the~          results of different kinds of vaccines.~        -  Researchers are interested in comparing the results of an experimental DNA vaccine for~          the prevention of seasonal influenza against a standard FDA-approved vaccine for the~          prevention of seasonal influenza. The experimental DNA vaccine is not yet approved by~          the FDA for preventing the flu.~      Objectives:~      - To test the safety and immune response of an experimental DNA vaccine for seasonal~     influenza, compared to the standard vaccine for seasonal influenza.~      Eligibility:~      - Healthy individuals between ages 45 and 70 who have not yet received the seasonal influenza~     vaccine.~      Design:~        -  Participants will have six planned clinic visits (Weeks 0, 1, 3, 4, 6, and 27) and two~          telephone follow-up contacts (within 2 days after each injection) during this study.~        -  Participants will be divided into two groups: one group will receive two standard (TIV)~          flu vaccine injections given using a needle and syringe, while the other will receive~          the DNA flu vaccine using a needleless injection system followed by the TIV vaccine.~        -  The vaccine injections for both groups will be given approximately 3 weeks apart,~        -  Clinic staff will observe participants for at least 30 minutes after each vaccination.~          One to two days after each injection, participants must telephone the clinic staff, and~          for 7 days after the vaccination participants will keep a diary card to report on~          possible side effects.~        -  During study visits, blood samples will be collected for research purposes to test for~          responses to vaccine.~   "
196145|NCT00995969|"~     This study will look at how safe and effective, a novel agent, CT 327 cream is in treating~     patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily~     for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed~     throughout the treatment period.~   "
196347|NCT00993304|"~     This trial is conducted in Europe. The aim of this trial is to investigate whether a new~     compound, liraglutide, reduces the level of lipids (fat), including cholesterol, in the blood~     of type 2 diabetics, following a meal with high fat content.~   "
196146|NCT00995956|"~     In this study we aim to investigate to what extent the serum albumin concentration in liver~     transplant patients treated with mycophenolic acid (MPA) affect the free fraction of MPA.~     Furthermore we will investigate if a change in free fraction has implications for the~     immunosuppressive effect of MPA by measuring the IMPDH activity. This might in the future~     provide opportunity for further individualisation of the treatment with MPA. We will also~     investigate if the stabilizers present in pharmaceutical-grade albumin have a displacement~     effect on MPA in Vitro (ref).~   "
196147|NCT00995930|"~     This study will evaluate the effect of ACZ885 on vascular function in patients with~     documented atherosclerotic disease and T2DM or IGT.~   "
196148|NCT00995917|"~     Many women, particularly adolescent women, suffer from painful menstrual cramps, medically~     referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal~     anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their~     use. Injection of vitamin K into an acupuncture point has been used as treatment for~     dysmenorrhea at the Obstetrics & Gynecology Hospital in Shanghai, China since at least 1985.~     More research is needed on the effectiveness of this treatment and its acceptability to~     different women. The objective of this study is to examine the feasibility and effectiveness~     of acupoint injection of vitamin K1 for the treatment of severe primary dysmenorrhea in the~     United States. Twenty participants will be randomized to receive either 1) vitamin K1~     injection into an acupuncture point at the start of their menstrual cycle followed by a~     saline injection in a non-acupuncture point two months later or 2) saline injection in a~     non-acupuncture point followed by vitamin K1 injection into an acupuncture point two months~     later. The primary outcome measure will be change in pain intensity measured before and after~     each treatment. Data on other menstrual symptoms will be collected by telephone or a~     web-based survey. Three additional participants will be recruited to receive vitamin K1~     injection into an acupuncture point and have blood samples drawn before and after injection~     to determine absorption of vitamin K1. The aims of the study are to collect preliminary data~     on the efficacy and safety of vitamin K1 injected in an acupoint for the treatment of severe~     primary dysmenorrhea; assess the feasibility and acceptability of the treatment among U.S.~     women; and test the blood absorption of vitamin K1 following acupoint injection treatment.~      The investigators hypothesize that:~        1. Vitamin K1 acupoint injection is a safe treatment for women with menstrual pain.~        2. Vitamin K1 acupoint injection reduces menstrual pain more than placebo saline injection~          does.~        3. The treatment of vitamin K1 acupoint injection is acceptable to U.S. women.~        4. Vitamin K1 is absorbed into the blood thru acupoint injection.~   "
196149|NCT00995904|"~     This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at~     three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable~     asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation~     aerosol delivery.~   "
196150|NCT00995891|"~     Background:~      - Laboratory research studies require control samples from healthy volunteers to compare with~     samples from patients. These studies will help researchers better understand and refine~     treatments for immune system and inflammatory diseases.~      Objective:~      - To obtain blood, urine, buccal (mouth) mucosa, normal tissue and bone marrow samples and/or~     leukopheresis cells from healthy volunteers.~      Eligibility:~      - Healthy individuals at least 8 years of age.~      Design:~        -  Volunteers will be recruited through the Program for Healthy Volunteers, Patient~          Recruitment and Public Liaison Office, or self-referral through the clinicaltrials.gov~          Web site.~        -  Health will be confirmed by a brief history and physical examination and blood work.~        -  Volunteers 8 years of age and older will provide blood and urine samples using standard~          procedures. Buccal mucosa samples will be obtained by scraping the insides of both~          cheeks with a sterile nylon brush.~        -  Bone marrow samples will be obtained from volunteers 18 years of age and older by taking~          two aspirates from the posterior iliac crest (an area near the hip).~        -  Normal tissue samples will be obtained from volunteers 18 years of age and older by~          taking superficial skin samples (punch biopsies)~        -  Leukopheresis or lymphapheresis will be performed on volunteers 18 years of age and~          older to obtain white blood cells for research~        -  Samples will be assigned a unique code and will be stored until they are no longer of~          scientific value or the volunteer withdraws consent for their use.~   "
196151|NCT00995878|"~     The primary goal of this study is to compare the safety and effectiveness of two standard~     fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization~     (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who~     do not plan to become pregnant.~      A second goal of this study is to better understand which symptoms bother women with fibroids~     the most. Understanding and addressing the symptoms of clinically-significant uterine~     fibroids is important in order to optimize treatment outcomes and control health care costs.~      Women who are eligible to participate in the study, are randomized to one of two treatment~     arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to~     choose which treatment she will receive.~      A comprehensive assessment of symptoms-including experienced pain- will take place at~     baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.~   "
196152|NCT00995865|"~     The Phase 1 trial is a single-center, randomized, double blind, placebo-controlled,~     dose-ranging out-patient study designed to provide the first clinical data on the safety,~     tolerability and immunogenicity of XRX-001 inactivated yellow fever vaccine in 60 healthy~     male and female volunteers, 18-49 years of age. Subjects will receive two inoculations of one~     of two dose levels of XRX-001 vaccine. A control group will receive placebo.~      Safety will be determined by the incidence and severity of adverse events in each treatment~     group and in the combined cohorts in the double blind treatment period up to 42 days~     post-vaccination. Subjects will also be followed-up at 3, 6 and 12 months to determine severe~     adverse events (SAEs) and changes in health status.~      Efficacy will be assessed by neutralizing antibody response to the vaccine. The co-primary~     immunogenicity endpoints will be the dose-response analysis of seroconversion rates (fourfold~     or greater increase in neutralizing antibody titer between baseline and Day 42) and of the~     50% plaque reduction neutralization test (PRNT50) geometric mean titers (GMT) at Day 42.~      Secondary immunogenicity endpoints will include:~        1. The seroconversion rates and GMT neutralizing antibody titers for all dose groups~          combined on Days 21 and 42.~        2. The reverse cumulative distribution curve of antibody titers on Days 21 and 42 for each~          dose group and for all dose groups combined~        3. The duration of antibody titers displaying the seroconversion rate and GMT across all~          time-points to Month 12, by treatment group and for both dose groups combined.~   "
196153|NCT00995852|"~     Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from~     unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.~   "
196154|NCT00995839|"~     The present study was conducted as a prospective, randomized study to investigate the effects~     of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and~     microcirculation in patients with catecholamine-dependent septic shock.~   "
196373|NCT00992966|"~     The VRI device may provide a complementary diagnostic tool for lung examination and aid the~     physician in determining whether a chest x-ray should be performed.~   "
196155|NCT00995826|"~     The purpose of this study is to test the safety and tolerability of an investigational~     multi-dose inhaled flu medication, CS-8958. Study participants will include 16 males and~     females, aged 18-55 years of age, inclusive. Participants will be divided into two treatment~     groups (Groups A and B) with each group consisting of 8 subjects. Participants will be~     involved in study related procedures for a maximum of 14 weeks from initial screen to the~     follow up visit. 6 subjects in Group A will be administered 40 mg of CS-8958 drug and two~     subjects will receive placebo (substance containing no medication), once a week for six~     weeks. In Group B six subjects will be administered 40 mg of CS-8958 drug and two subjects~     will receive placebo, twice a week for six weeks. Study procedures will include blood and~     urine samples, ECGs (measure of heart activity), blood pressure, pulse rate and functional~     oxygen saturation of arterial hemoglobin. Also continuous cardiac telemetry will be performed~     as well as physical examinations and spirometry assessments.~   "
196156|NCT00995813|"~     The purpose of this study is to assess the safety and immune response of the rotavirus~     vaccine in infants who have undergone abdominal surgery.~   "
196157|NCT00995800|"~     This is a dose-response study to determine how various measurements of airway inflammation~     respond to high and low dose FlutiForm®, and compared to placebo.~   "
196158|NCT00995787|"~     The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM~     patients treated with metformin and sulfonylurea.~   "
196159|NCT00995774|"~     The goal of this project is to develop and test a new robotic system to accommodate practice~     of tasks requiring reach, grasp and release of objects. Our previous work has shown that the~     MIME robot is safe and effective for improving reach in stroke subjects. But adequate control~     of hand movements is critical to a functional upper limb, and is often resistant to~     conventional therapeutic interventions. Many stroke survivors have residual ability to flex~     the fingers, but extension is often limited and impeded by increased passive stiffness in~     flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent~     study, 38% of stroke survivors reported that impaired hand function was the most disabling~     motor impairment they faced.~   "
196160|NCT00995761|"~     The rationale of phase II study of biweekly docetaxel and cisplatin in patients with~     unresectable NSCLC are follows:~      First, the optimal dose and schedule of combination with docetaxel and cisplatin are still~     controversial (3 weekly versus weekly).~      Platinum-based combination chemotherapy improves the survival of patients with advanced~     non-small cell lung cancer (NSCLC) in the first-line setting.~      Combination chemotherapy with docetaxel and cisplatin is one of the standard platinum-based~     regimens for treating NSCLC. However, usual standard 3 weekly regimen with docetaxel and~     cisplatin have consistently produced frequent Grade 3-4 neutropenia, and febrile neutropenia.~      Although weekly docetaxel and cisplatin is better tolerated than chemotherapy every 3 weeks,~     especially in the first line setting in terms of myelosuppression, the optimal dose and~     schedule for administration of the two drugs has not yet been determined.~      Both 3-weekly docetaxel plus cisplatin and weekly schedule showed similar response rates but~     had different toxicity profiles. The most frequent grade 3 or 4 toxicities were neutropenia~     in the 3 weekly schedule and fatigue or asthenia in the weekly schedule.~      Second, docetaxel and cisplatin have different action and mechanism. Docetaxel showed~     characteristic early bone marrow suppression 5-7 days after infusion compared with usual 14~     days after infusion of cisplatin. Thus, nadir period is not overlapped when the investigators~     administered both drugs concomittantly.~      Third, there are many feasible reports of biweekly administration of docetaxel in patients~     with NSCLC, breast cancer, stomach cancer, and ovarian cancer with better safety profiles.~      Therefore,the investigators designed this phase II study to evaluate the efficacy and~     toxicity of biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC~     and test the hypothesis that biweekly schedule of docetaxel and cisplatin is better tolerated~     than both standard 3 week and weekly schedule in terms of hematologic (neutropenia) and~     non-hematologic toxicities (asthenia, interstitial pneumonitis. Additionally the~     investigators will evaluate polymorphism associated with this study.~   "
196161|NCT00995748|"~     The Primary objective of this registry is to assess the control of Atrial Fibrillation (AF)~     over one year in patients attending clinical or specialized practices.~      The Secondary objectives are:~        -  To describe key demographics and treatment features in AF patients visiting~          cardiologists in various countries in Asia-Pacific.~        -  To establish correlation between control of AF and clinical outcomes.~        -  To establish correlation between treatment strategies and AF control.~   "
196162|NCT00995735|"~     Objectives: Since 2007, natural orifice surgery evolved from theory and animal research to~     clinical applications, but is still limited in the literature to small casuistic reports. A~     preliminary prospective evaluation of postoperative results of the early casuistic of Natural~     orifice Surgery for many indications may show advantages and disadvantages of the methods.~     The IMTN Multicenter Trial for Clinical NOTES was and early results are described.~   "
196163|NCT00995722|"~     The purpose of this study is to evaluate the efficacy and tolerability of prednisone in~     patients diagnosed with ocular myasthenia.~      Funding Source - FDA OOPD~   "
196164|NCT00995709|"~     The purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive~     therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to~     Behçet's disease during the 24 weeks of study therapy as compared to standard of care alone.~   "
196165|NCT00995696|"~     This study will assess the effectiveness of a medication safety monitoring method utilizing~     interactive voice response technology for youth recently prescribed anti-depressant~     medication.~   "
196166|NCT00995683|"~     The goal of this study is to evaluate the effect of preventive intravenous infusion of half~     molar sodium lactate on the onset of hypertensive intracranial episodes in severe head~     trauma. The investigators hypothesize that preventive intravenous administration of sodium~     lactate will decrease the number of treatments required to decrease intracranial pressure~     during 48 hours.~   "
196167|NCT00995670|"~     Anesthetic preconditioning (APC, a brief exposure to an anesthetic gas) has become an area of~     intense research interest because of its ability to protect tissue and organs from injury~     resulting from a cessation of blood flow and then a re-establishment of flow. The blood~     vessel lining plays a key role in this injury. This research will examine, in human~     volunteers, several important modifiers of APC in human blood vessels: high blood sugar,~     vitamin C, and statin drugs. Thus, the proposed studies will advance the investigators'~     understanding of mechanisms of this injury in humans and explore important modifiers of APC~     protection from injury.~   "
196209|NCT00995124|"~     The purpose of this study is to compare the ovicidal activity of three head lice treatment~     products.~      The study population will consist of Queensland primary school-aged children (Grades 1 - 7)~     who have at least 20 live eggs on the hair and who have not used any head lice product in the~     four weeks prior to the study.~      Enrollment will continue to achieve 30 subjects in each treatment group (total of 90~     subjects).~   "
196374|NCT00992953|"~     It is proposed that using Virtual Reality as part of therapy will result in improvements in~     Post Traumatic Stress Disorder for Service Members with PTSD related to service in Iraq~     and/or Afghanistan.~   "
196168|NCT00995657|"~     Asthma is a chronic disease, which means that it cannot be cured, but the investigators can~     use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and~     irritated which can cause coughing and make the airways tighten. This 'inflammation' is the~     root of the problem in asthma. Doctors have different ways to measure the inflammation in the~     airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by~     the lungs when asthmatic inflammation is present. The investigators have been using NO as a~     test in research labs for many years, but there are still unanswered questions about how it~     changes between morning and night and how quickly medicines work on it. In most asthmatics,~     even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in~     some people this does not seem to happen. The investigators now have portable NO machines~     that are designed for patients to use in the home. The investigators want to follow NO~     readings in patients with high levels to measure how they respond to different doses of~     steroid inhalers. The investigators hope this will help the investigators better understand~     asthma inflammation and treatments.~   "
196169|NCT00995644|"~     Smoking cessation can be enhanced either by increasing the success of quit attempts or by~     increasing in the number of quit attempts. The investigators are interested in what causes a~     smoker to make a quit attempt. The investigators will test whether certain events (e.g., a~     request from a child to quit smoking or exposure to a smoking-related health message)~     increase the probability of a quit attempt in the near future. The investigators are will~     test whether planning behaviors (e.g. seeking information about treatment) and setting a quit~     date are common and increase the probability of a quit attempt. Finally, the investigators~     want to see if spontaneous, unplanned quit attempts are common and are more or less~     successful than delayed, planned quit attempts. In a pilot study, the investigators will~     develop measures of the most common events and planning activities. In the main study, the~     investigators will recruit 200 adult daily smokers who are interested in quitting in the next~     3 months. They will call a phone daily and use the phone's keypad to enter data plus they~     will complete mailed or internet questionnaires weekly for 3 months. The results of this~     study will a) help us understand what prompts smoking cessation attempts, b) help develop~     media messages and individual interventions to motivate smokers to make a quit attempt, and~     c) help determine whether spontaneous, impulsive quit attempts or delayed, planned quit~     attempts should be encouraged.~   "
196170|NCT00995631|"~     The typical female pattern of accumulating fat in the hips and thighs has long been thought~     to confer less risk for disease than the typical male abdominal fat pattern. However, leg fat~     may not simply be benign with respect to disease risk, but may in fact protect against~     cardiovascular disease risk. Although the mechanism for this is unknown, the investigators~     hypothesize that removing a portion of this important fat depot (via liposuction) could~     increase disease risk. Such unfavorable results may or may not be transient depending on an~     individual's ability to defend their fat mass. Because sex hormones appear to play a role in~     regional fat accumulation, the investigators hypothesize that estrogen-deficient~     postmenopausal women may have an augmented abdominal fat accumulation and an attenuated hip~     and thigh re-accumulation compared to premenopausal women following lipectomy and compared to~     non-surgical controls. As a result, the increased abdominal fat accumulation may worsen~     disease risk in postmenopausal women. Menopause-related differences in fat storage at~     baseline are also expected to determine the degree to which lipectomy alters disease risk and~     the propensity for AT re-accumulation.~   "
196171|NCT00995618|"~     This is a randomized, double-blind, 3-period crossover phase 2 study in patients with~     documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics~     (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and~     PD as measured by reduction in serum uric acid levels.~   "
196172|NCT00995605|"~     The purpose of this study is to determine whether AMAP102 is safe and well tolerated by~     humans.~   "
196173|NCT00995592|"~     Malnourished children and babies with birth weights under 2500 grams are at high risk for~     negative outcomes over their lifespan. Philani, a paraprofessional home-visiting program, was~     mounted in neighborhoods in three townships in Cape Town, South Africa, from 2002 to 2004 to~     improve nutritional outcomes.~      One mentor mother was recruited from each of 37 neighborhoods. Mentor mothers were trained to~     conduct home visits to weigh children and to support mothers to problem-solve life~     challenges, especially around nutrition. Households were randomly assigned on a 2-to-1 ratio~     to the Philani program or to a standard care condition. Children were evaluated over a 1-year~     period.~      The investigators hypothesized that children in the intervention would gain more weight than~     children in the control.~   "
196174|NCT00995579|"~     The purpose of this study was to measure the actual energy expenditure (EE) using indirect~     calorimetry for the 10,000 steps goal, and compared to the estimated EE using predictive~     equation.~   "
196175|NCT00995566|"~     The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU)~     that is designed to supplement the reporting of spontaneous adverse events (AE) and better~     characterize known and potential safety signals for Thelin. The registry is a secure,~     restricted access, electronic system which collects anonymous, pre-defined, patient-level~     data on demographic variables, safety monitoring measurements (i.e. liver function tests,~     haemoglobin and international normalized ratio (INR) measurements), concomitant medications,~     information on AEs and Thelin drug discontinuation. Regular review of the data is conducted~     to assess the frequency of identified safety risks and to monitor for the emergence of new~     safety signals at monthly pharmacovigilance meetings, quarterly signal detection meetings,~     and for each Periodic Safety Update Report (PSUR).~   "
196210|NCT00995098|"~     There is increasing evidence that indicates early enteral nutrition may be associated with~     improved outcome in acute pancreatitis patients. However, most of the clinical trials~     regarding this targeted mild to moderated pancreatitis patients. In regard to severe acute~     pancreatitis (SAP) patients, current results from randomized control trials (RCTs) are~     inconclusive. The researchers of this study aim to investigate the impact of early enteral~     nutrition on the clinical outcomes of SAP patients.~   "
196211|NCT00995085|"~     This clinical study is designed to evaluate the safety and tolerability of a single oral~     administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD.~     Study also assess cognitive effects of such drug administration.~   "
196176|NCT00995553|"~     The primary aim of the study is to test the efficacy of a novel cognitive remediation~     intervention that targets working memory-related functions. To accomplish this goal, 80~     volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive~     remediation condition that targets working memory or a computer skills training intervention~     that teaches computer applications. In both conditions participants will receive computer~     training three times a week for 4 months. The investigators hypothesize that patients who~     receive the cognitive remediation intervention will demonstrate significantly greater change~     on neuropsychological measures of working memory and executive abilities than patients who~     receive the computer skills course. In addition, the investigators hypothesize that the~     intervention-induced cognitive change will be associated with concurrent improvements in~     functional capacity and psychosocial functioning in the community. A second study goal is to~     examine the stability of the intervention-induced changes in cognition. Cognition and~     psychosocial functioning will be reassessed 4 and 8 months after treatment termination to~     examine the stability of treatment effects and to assess whether a less intense maintenance~     training (once a week sessions) provides any additional benefit to participants. Lastly, this~     study will examine in an exploratory manner whether there are individual differences in~     treatment response. The Val158Met polymorphism of the COMT gene has been found to be~     associated with working memory and prefrontal dysfunction in schizophrenia. The study will~     test whether the COMT polymorphism is predictive of response to cognitive remediation.~   "
196177|NCT00995540|"~     INGAP Peptide acetate is the active ingredient of INGAP Peptide Solution for Injection. It is~     being developed as an antidiabetic agent for the restoration of endogenous insulin secretion~     in patients with type 1 diabetes mellitus (T1DM) and in insulin-deficient patients with type~     2 diabetes mellitus (T2DM). This clinical study is designed to generate additional data~     regarding the appropriate dose and dosing regimen and to evaluate safety and efficacy in~     patients with T1DM.~   "
196178|NCT00995527|"~     Background:~        -  The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is conducting~          research investigating how the swine flu (H1N1) vaccine affects the immune system. The~          exposure to the new swine flu vaccine gives us a rare opportunity to learn about how the~          human immune system responds to a new vaccine.~        -  Researchers are interested in collecting blood samples from individuals who have~          received the vaccine. Participants will be selected from a group of healthy volunteers~          who will be receiving the H1N1 vaccine because it is mandatory for their work at the~          National Institutes of Health. This protocol will be one of the first studies to~          characterize the human innate immune response to H1N1 vaccine.~      Objectives:~      - To collect blood samples for research purposes before and after participants receive a~     standard non-research vaccination against swine flu (H1N1).~      Eligibility:~        -  Healthy individuals 18 years of age and older who are employees of the National~          Institutes of Health.~        -  Individuals who have had confirmed cases of influenza in the past year are not eligible~          to participate.~      Design:~        -  Participants will be admitted for a 36-hour inpatient stay, during which blood samples~          will be taken frequently. Participants will have a standard intravenous catheter~          (similar to the one used for intravenous infusions) put in place to avoid multiple~          needle sticks.~        -  Participants will be assigned into one of two groups; the two groups differ in the~          timing of blood draws but not in the overall amount of blood drawn.~        -  Group 1: Blood samples 30 minutes before and immediately before vaccination. Additional~          samples will be taken 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 30, and 36 hours after~          vaccination.~        -  Group 2: Blood samples 30 minutes before and immediately before vaccination. Additional~          samples will be taken over the following 36 hours, with exact timing to be determined~          based on the findings from group 1.~        -  All participants will provide blood samples 7 days after being released from the~          inpatient stay.~        -  Because of the amount of blood being drawn for research, participants should not donate~          blood or take part in any other protocols that collect blood while participating in this~          study.~   "
196179|NCT00995514|"~     The primary objective of this trial is to demonstrate the non-inferiority of clopidogrel~     compared to prasugrel over 6 months in cardiovascular disease patients when the clopidogrel~     cohort is limited to the estimated 70% of the population that are CYP2C19 extensive~     metabolizers. This protocol will examine the comparative effectiveness of these two~     strategies.~   "
196180|NCT00995501|"~     Evidence thus suggests that steroid administration, tight glucose control, and avoidance of~     deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to~     surgery. Using a three-way factorial approach, the investigators thus propose to test the~     primary hypotheses that major perioperative morbidity is reduced by: 1) low-dose~     dexamethasone; 2) intensive perioperative glucose control; and 3) lighter anesthesia.~      Secondary hypotheses include that each intervention reduces circulating concentrations of the~     inflammatory marker CRP, and that there is a correlation between C-reactive protein (CRP) and~     post-operative complications. Anesthetic sensitivity predicts major and minor complications,~     and delirium Other secondary hypotheses are that each intervention, reduces minor surgical~     complications, reduces postoperative nausea and vomiting (PONV), reduces postoperative~     delirium, speeds hospital discharge, improves quality of life (SF-12v2 Health Survey,~     Christensen's VAS fatigue score), and reduces all-cause one-year mortality.~   "
196181|NCT00995488|"~     This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin~     and gemcitabine in the treatment of patients with advanced bladder cancer.~      Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based~     chemotherapy in this setting has activity but is not curative. Furthermore, patients with~     this disease have comorbidities that limit the use of cisplatin based therapy. Combination~     paclitaxel, carboplatin and gemcitabine is active and well tolerated in this patient~     population.~      Paclitaxel is formulated with ethanol and a Cremophor EL (polyoxyethylated castor oil) which~     contribute to the side effects associated with paclitaxel. ABI-007 (brand name Abraxane™) is~     a form of paclitaxel that does not contain these additives and may deliver more drug to tumor~     cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the~     treatment of metastatic (advanced) breast cancer based on superior anticancer effect, and is~     being evaluated in other cancers in research studies.~   "
196182|NCT00995475|"~     Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers~     are now an established treatment for COPD. Inhaled steroids can have a number of bad effects~     including suppression of the adrenal glands because of absorption. A previous study in~     patients with COPD.~      C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation.~     Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP~     have also been found in patients with COPD. In some studies, steroid inhalers have reduced~     CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown~     whether this reflects a reduction in lung inflammation or an effect of systemically absorbed~     corticosteroid.~      It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung~     inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.~   "
196183|NCT00995462|"~     This study assess whether a small-group seminar intervention to prevent weight gain is~     effective in a general university student population, and to address the relative role of~     biological vs. lifestyle factors in predicting weight gain in humans.~   "
196185|NCT00995436|"~     Research problem:~      Anchorage reinforcement is effective with headgear provided patient compliance is optimal.~     Nance palatal arch have also been shown to be effective. Microscrews despite their popularity~     however have no scientific evidence to support their use.~      Aim:~      To compare the effectiveness of 3 methods of anchorage reinforcement 1) headgear 2) Nance~     palatal arch 3) orthodontic micro-screws.~      Hypothesis:~      There is no difference in the amount of anchorage loss between the three methods of anchorage~     reinforcement.~      Design:~      Randomized clinical trial.~      Setting: District General Hospital orthodontic department~      Participants: 78 patients requiring absolute anchorage.~      Interventions: The subjects will be randomized into 3 groups. In group 1 headgear will be~     requested 12-14 hours per day. In group 2 a nance palatal arch will be placed for use as~     intra oral anchorage reinforcement. In group 3, orthodontic micro-screws will be used for~     anchorage.~      Method of investigation:~      The study will be of 78 'absolute anchorage' patients older than 12 years randomly assigned~     to one of three groups of anchorage reinforcement~      Outcome measures:~        1. Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning,~          records will be taken at three points~        2. Patient perception of the different treatment methods, including surgical experience~      Data analysis: The data will be analysed on an intention to treat basis. Basic descriptive~     statistics and uni-variate tests will initially be done to explore the data. Final data~     analysis will involve the relevant multi-variate statistical modeling.~      Dissemination: Conference proceedings, journal papers and the Cochrane oral health group.~   "
196186|NCT00995423|"~     The purpose of this study is to assess whether the outcome of treatment with CoroflexTM~     Please stent is not inferior to the outcome of treatment with TAXUS stent.~   "
196187|NCT00995410|"~     This study uses an open-label design and will be conducted in approximately 40 sites in the~     United States. Approximately 400 subjects will be enrolled in the study to ensure that~     approximately 300 subjects will have 6 months exposure to PA32540 and at least 100 subjects~     will have 12 months exposure to PA32540.~   "
196188|NCT00995397|"~     Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by~     mast cells in the skin. Topical anti-histaminics can be used to promote relief of these~     symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation~     approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the~     ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority~     of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the~     standard preparation (1% cream) for the relief of insect bite related symptoms and to~     demonstrate the safety of both preparations.~   "
196189|NCT00995384|"~     The purpose of this study is to assess the effectiveness of cardiac CT versus TEE in~     endocarditis patients.~   "
196190|NCT00995371|"~     This is a single-center, randomized, prospective, double-blind clinical study to assess the~     clinical application and outcomes with MILD® devices versus epidural steroid injection in~     patients with symptomatic moderate to severe central canal spinal stenosis.~   "
196191|NCT00995358|"~     The purpose of this study is to evaluate overall survival and immunological monitoring for~     peptide vaccination therapy using novel cancer testis antigens for locally advanced,~     recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).~   "
196192|NCT00995345|"~     The purpose of this study is to assess the safety and effectiveness of KRP-104 on glycemic~     control in patients with type 2 diabetes inadequately controlled on metformin alone.~   "
196193|NCT00995332|"~     Hypothesis: Combined treatment with valproic acid and ATRA can be used to achieve disease~     stabilization for a subset of patients with acute myelogenous leukemia (AML), and this effect~     can be improved without serious toxicity by adding low-dose cytarabine to this treatment.~      Adult patients >18 years of age who can be included:~      Elderly patients who cannot achieve standard chemotherapy, patients with relapsed or~     resistant AML.~      Treatment: Combined therapy with:~      Valproic acid, continuous therapy until disease progression ATRA, oral therapy for 14 days~     every three months Low-dose cytarabine 10 mg/m2 up to 10 injections during week 2 and 3,~     repeated every 3 months.~   "
196194|NCT00995319|"~     The purpose of this clinical investigation is to evaluate acute and longlasting side effects~     in patients undergoing radiotherapy for cancer treatment in the head and neck area.~   "
196195|NCT00995306|"~     To evaluate the safety and efficacy of Civamide Cream 0.075% as a treatment of the signs and~     symptoms associated with osteoarthritis of the knee.~   "
196196|NCT00995293|"~     The Primary Objective is to evaluate the progression-free survival after treatment with~     docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus~     5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to~     evaluate and compare the clinical response rate both before and after radiotherapy, the local~     symptoms, the duration of response, the time to treatment failure, the survival, the toxicity~     and the quality of life in the 2 study groups.~   "
196197|NCT00995280|"~     The aim of this study is to compare whether oocyte flushing during retrieval is effective or~     not.~   "
196212|NCT00995072|"~     Beta-blockers (BB) are an important treatment for high blood pressure and heart disease.~     However beta-blockers can cause sexual dysfunction (SD) and this common side effect limits~     successful use of this class of medications. Sexual side effects often result in drug~     discontinuation, compromising therapy goals. The investigators are conducting the study to~     determine if nebivolol, a newer beta blocker that is selective for receptors in the heart and~     causes vasodilation in the body causes fewer sexual side effects, or even improves sexual~     function, compared with metoprolol succinate.~   "
196213|NCT00995059|"~     Rationale: Giving bortezomib and low doses of chemotherapy and total-body irradiation before~     a donor stem cell transplant or peripheral blood stem cell transplant helps stop the growth~     of cancer cells. It also stops the patient's immune system from rejecting the donor's stem~     cells. The donated stem cells may replace the patient's immune cells and help destroy any~     remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a~     donor can also make an immune response against the body's normal cells. Giving sirolimus and~     tacrolimus before and after transplant may stop this from happening.~      Purpose: This phase I/II trial is studying the side effects and best dose of bortezomib~     before donor stem cell transplant in treating patients with multiple myeloma.~   "
196198|NCT00995267|"~     Purpose: In the framework of a randomized concurrent controlled trial, to assess the~     effectiveness of a feasible educational mechanism based on the principles of Alfred Adler,~     that focuses on the family, to improve the dietary habits of schoolchildren, to induce them~     to increase their physical activity, and to prevent obesity and diseases related to obesity.~     Primary Objectives for Children: 1.To increase intake of fruits and vegetables, to reduce~     intake of sweets and unhealthy snacks at home and in school, to increase exercise and to~     reduce sedentary activities. Primary Objective for the Parents: Increase the involvement of~     parents in the education of their children regarding nutrition.~      Description: Study population: Approximately 600 students and 600 parents from 24 first grade~     classes in 4 schools. Schools are randomized into intervention and control groups. The~     intervention comprises a 5-session parental workshop and 5 joint parent-child school-based~     activities. The control group will be offered the intervention after conclusion of the trial.~      Participants are recruited in first grade, anthropometrics are measured, and pupils and~     parents are interviewed on eating habits and exercise. Snacks are observed. The intervention~     takes place in the second grade, and outcome assessment is done at the end of the 2nd grade~     and beginning of the 3rd grade. In-depth interviews will be conducted with parents of obese~     children.~      Significance: Most interventions geared to prevention of childhood obesity have failed~     dismally. A new approach that focuses on the parent-child interaction may be contributory.~   "
196199|NCT00995254|"~     Second hand smoking (SHS) is a health hazard to infants and children, in whom it is~     associated with lower respiratory tract infections, wheezing, cough, middle ear infections~     and sudden infant death syndrome. Evidence from developed nations suggests that measures to~     reduce exposure to SHS can improve children's health outcomes; this has not been~     systematically studied in a developing country setting. The investigators hypothesize that~     implementation of a package of smoking hygiene intervention measures delivered by community~     health workers (CHWs) will reduce Chinese children's exposure to SHS and improve their~     respiratory health.~      To test this hypothesis, the investigators have identified three specific aims: (1) to obtain~     baseline data on second hand tobacco exposure among young children, health status of young~     children and smoking status of parents and other household members, (2) to generate~     preliminary effectiveness data for CHW-delivered SHI, and (3) to develop culturally~     appropriate biochemical measures to assess children's exposure to household SHS. The~     investigators propose to conduct this study in an urban district in Shanghai, China. After an~     initial assessment, the investigators will conduct a randomized controlled trial of~     households in a community, selected based on important study criteria, within the district.~     The investigators selected this design because it is most likely to produce a scientifically~     valid answer to our primary study question. All eligible smokers in the intervention group~     will receive behavioral counseling to address health hazards of SHS towards children, brief~     advice to quit or to adopt a no smoking policy around children, and educational pamphlets on~     the hazards of SHS, from a trained CHW in their community. A questionnaire will be used for~     data collection at the start and at 2 and 6 months. To assess the extent of total SHS~     exposure, children's urine cotinine (the indicator of nicotine) level will be measured at the~     first contact and at 2-and 6- months. To validate household members reported level of smoking~     the investigators will measure air nicotine levels of a sub-sample (10%) of households via~     passive monitors. The results of this study will provide clinical evidence for the~     development of CHW-delivered interventions designed to reduce exposure to SHS and improve the~     respiratory health of children in a resource-poor community. If successful, the program can~     serve as a model for implementation in other developing country settings. Furthermore,~     successful results could also be used to draft guidelines for health promotion interventions,~     which could be implemented as a policy for all primary health care settings. Finally, the~     study, which would be the first of its type in a developing country setting, will form the~     basis for future research and program development in the area of SHS.~   "
196200|NCT00995241|"~     The purpose of this study is to compare plasma and intracellular pharmacokinetic parameters~     of raltegravir 800 mg administered once daily in HIV infected patients.~   "
196201|NCT00995228|"~     Peri-operative fluid therapy is a controversial area with few randomized trials to guide~     practice. Fluid management has a significant influence on outcome following surgery. Yet~     practically, fluid prescription practice during this period is sub-optimal, resulting in~     avoidable iatrogenic complications.~      Several studies have assessed the effect of a 'liberal' vs. a 'restrictive' perioperative~     fluid regimen on post-operative outcome. However, most of these studies have focused~     primarily on intra-operative fluid management, whereas postoperative strategies have been~     less well defined, even though the immediate postoperative period is of critical importance~     to the patient's recovery. Moreover, whereas intra-operative fluid administration is~     monitored by the anesthesiologist, postoperatively it is less supervised and may result in~     excess or lack of intravenous (IV) fluids. Therefore, fluid management audit at the~     post-anesthesia care unit (PACU) is of paramount importance for patient healthcare. The~     objective of this study is to follow and report the current practice of fluid administration~     in the PACU of Tel Aviv Sourasky Medical Center, for an extended period of time as a first~     step towards establishing evidence-based guidelines for postoperative fluid management.~   "
196202|NCT00995215|"~     Respiratory infections, such as pneumonia and bronchitis, occur frequently in the spinal cord~     injured population, due to paralysis of the muscles responsible for coughing. Using spinal~     cord stimulation techniques, these muscles can be activated to restore an effective cough~     mechanism.~   "
196203|NCT00995202|"~     RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA~     assessment, may help monitor a patient's response to surgery. It is not yet known which~     follow-up regimen is more effective in patients who have undergone surgery for colorectal~     cancer.~      PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or~     without CEA assessments to see how well they work in patients who have undergone surgery for~     stage II or stage III colorectal cancer.~   "
196204|NCT00995189|"~     The purpose of this study was to clinically evaluate the potential causes of contact~     lens-related dry eye.~   "
196205|NCT00995176|"~     Approximately 30 percent of new HIV infections in the Unites States occur in women, with a~     disproportionate number occurring in women of color. This observational study has been~     designed to help determine the HIV incidence among women in the study communities as well as~     to identify steps that women can take to lower their HIV-infection risk.~   "
196206|NCT00995163|"~     The MBD-5D is a prospective observational study with a case-cohort and a cohort design.~     Eligible patients are receiving hemodialysis and have secondary hyperparathyroidism. The~     study's three goals are (1) to record the patients' characteristics, and variation in the~     patterns of their treatment; (2) to analyze factors associated with variation in those~     medical practice patterns; and (3) to identify practice patterns and other factors that~     affect hospitalization, mortality, and other patient-level outcomes.~   "
196207|NCT00995150|"~     The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing~     intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who~     request long-term, reversible contraception for up to 10 years.~   "
196208|NCT00995137|"~     This study will determine the maximum tolerated dose of genetically modified natural killer~     (NK) cells in research participants with relapsed or refractory B-lineage acute lymphoblastic~     leukemia (ALL).~   "
196214|NCT00995046|"~     Patients with severe haemophilia A lack clotting factor FVIII and suffer from spontaneous and~     traumatic bleeds. In the absence of treatment, frequent bleeds in joints lead to severe joint~     destruction. In 1960s, prophylactic therapy was developed involving the infusion of clotting~     factor on a regular schedule in order to keep clotting levels sufficiently high to prevent~     spontaneous bleeding episodes. Prophylaxis is started at an early age before the age of 2~     years or after the first joint bleed. The Malmö experience indicates that treatment is most~     effective when administered in large doses at least 3 times weekly. However, such an~     intensive treatment in young boys may be very difficult to carry out for home treatment.~     Currently, there is no international recommendation on prophylactic therapy regimens. Because~     of the high cost and limited availability of factor concentrates, dosing is an important~     issue in prophylaxis therapy. It was recently shown that 24 hours after FVIII concentrate~     administration, in patients presenting similar FVIIII levels, thrombin generation capacity~     may be significantly different. In addition, independently of the FVIII level, a correlation~     was found between severe clinical bleeding phenotype and thrombin generating capacity. The~     aim of the present clinical study is to assess the thrombin generation test as the main~     surrogate marker to evaluate the coagulating capacity of haemophiliacs on prophylaxis~     regimen. Optimizing prophylactic therapy to patient's phenotype with no loss of clinical~     effectiveness can significantly improve patients' quality of life, protect haemophilic~     children against arthropathy and possibly limit the cost of the prophylaxis therapy.~   "
196215|NCT00995033|"~     The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered~     with varenicline as an aid in smoking cessation over a one-year period in smokers who want to~     quit smoking.~   "
196216|NCT00995020|"~     The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of~     Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of~     Transformation Zone cone biopsy) in the management of pre-invasive endocervical disease.~      SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be~     compared to LLETZ cone, which is performed with a large loop electrode.~   "
196217|NCT00995007|"~     Background:~        -  Growth of new blood vessels (angiogenesis) provides many tumors, including brain tumors,~          with needed nutrients and oxygen for cancer cells to survive. One possible treatment for~          different kinds of cancer involves treatment with drugs that slow or stop angiogenesis~          and prevent further tumor growth.~        -  Vandetanib is an oral medication known to block angiogenesis and has shown significant~          antitumor activity in laboratory and animal studies. Vandetanib appears to be well~          tolerated by patients at specific daily doses.~        -  Carboplatin is a drug that interrupts division of cancer cells and has been shown to be~          a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating~          brain tumors, but researchers are interested in gathering more information about how it~          works as a treatment for patients who have not responded to initial surgery, radiation,~          or chemotherapy.~      Objective:~      - To determine the safety and effectiveness of vandetanib and carboplatin, given together or~     sequentially, against recurrent high-grade gliomas.~      Eligibility:~      - Adults diagnosed with a malignant glioma who have received standard treatments that no~     longer appear to be effective.~      Design:~        -  Patients will be assigned to one of two groups. Group 1 patients (combination group)~          will receive oral vandetanib for 28 days and intravenous (IV) carboplatin (once at the~          beginning of the 28-day cycle). Group 2 patients (sequential group) will receive IV~          carboplatin alone (once at the beginning of the 28-day cycle) and then oral vandetanib~          (300 mg daily) for 28 days if the tumor grows or the patient develops unacceptable~          carboplatin toxicity.~        -  Treatment will continue in 28-day cycles for 1 year for both groups.~        -  Patients will undergo a number of tests and procedures during the treatment cycle,~          including physical examinations, routine laboratory tests, electrocardiograms, and~          magnetic resonance imaging (MRI) scans~        -  At the end of 1 year of treatment, patients will be reevaluated for possible~          continuation of drug therapy.~   "
196218|NCT00994994|"~     Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery.~     Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict~     results. The reason why they showed mixed results would be the imbalance of patients~     population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric~     cardiac surgery with well balanced patients population.~   "
196219|NCT00994981|"~     The purpose of this study is to evaluate the effect of intravenous magnesium infusion before~     reperfusion with employing some clinical parameters including blood lactate levels, because~     the intraoperative changes in the blood lactate levels after hepatic allograft reperfusion~     served as an accurate predictor of the initial graft function in living donor liver~     transplantation.~   "
196220|NCT00994968|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,~     docetaxel, and S-1, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed.~      PURPOSE: This phase II trial is studying giving doxorubicin hydrochloride together with~     cyclophosphamide, docetaxel, and S-1 before surgery in treating women with stage II or stage~     III breast cancer.~   "
196221|NCT00994955|"~     Selective Retina Therapy (SRT) is an effective and safe laser treatment of clinically~     significant diabetic macular edema which targets the retinal pigment epithelium while sparing~     the neurosensory retina.~   "
196222|NCT00994942|"~     Determine the pharmacokinetics and optimize study design for subsequent studies with morphine~     sulfate tablets and solution.~   "
196223|NCT00994929|"~     The purpose of this study is to determine the biologic efficacy and safety of rhIL-11 when~     given subcutaneously in adults with moderate or mild hemophilia A or Von Willebrand disease~     unresponsive to DDAVP. Biologic efficacy will be measured by the number and percent increase~     of VWD coagulation tests (FVIII:C, VWF: Ag, VWF: RCo, closure time, APTT, and VWF multimers)~     to the normal range, or at least to 1.5-3 time baseline, following dosing of rhIL-11 when~     given daily for 4 days, and boosted by DDAVP infusion on day 4, in those in whom DDAVP is not~     contraindicated. Safety will be measured by the frequency of adverse events, including fever,~     headache, fatigue, myalgias, arthralgias, fluid retention, or edema.~   "
196224|NCT00994916|"~     The purpose of the study is to provide expanded access (compassionate use) of 3,4~     diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).~   "
196269|NCT00994331|"~     The Stereotaxis Niobe® II Magnetic Navigation System (MNS) is designed to direct and~     digitally control catheter and guidewire based therapeutic and diagnostic devices along~     complex trajectories within the heart and coronary vasculature.~      Navigation using vectors acquired from the CT Co-registration feature of Navigant™ provides~     clinical benefits for percutaneous coronary intervention (PCI) by decreasing the amount of~     contrast used during complex PCI procedures.~   "
196225|NCT00994903|"~     Statins (HMG-CoA reductase inhibitors) are a widely used class of cholesterol-lowering drugs~     that have an established role in the medical management of cardiovascular disease. Their~     benefits have also been shown in the surgical setting with decreased cardiovascular~     complications and lower perioperative mortality following cardiac and vascular surgery. There~     is now considerable evidence showing statins have useful pleiotropic properties that extend~     beyond cholesterol lowering, including anti-inflammatory, anti-oxidant, immunomodulatory and~     fibrinolytic effects. Growing evidence suggests these effects may be useful in attenuating~     the proinflammatory and metabolic stress response to surgery and the benefit of statins may~     extend to other surgical settings such as abdominal surgery.~      Laboratory studies demonstrate the surgically-relevant benefits of statins and show they~     decrease peritoneal inflammation, reduce the severity of intestinal ischaemia-reperfusion~     injury, improve survival in models of abdominal sepsis, decrease the formation of~     postoperative intraperitoneal adhesions and improve the healing of colonic anastomoses.~     Retrospective clinical studies show statins improve outcomes in sepsis, reduce the~     postoperative systemic inflammatory response syndrome (SIRS) and are associated with~     decreased rates of surgical wound infections and postoperative respiratory complications~     following various non-cardiac general surgical procedures. However, no prospective studies~     have specifically evaluated the perioperative use of statins in abdominal surgery. Using~     colorectal surgery as a model for major abdominal surgery, the investigators will conduct a~     randomised controlled trial evaluating the effect of perioperative statin use on~     postoperative morbidity, local and systemic inflammatory response, and functional recovery~     after surgery.~   "
196226|NCT00994890|"~     This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg,~     and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times~     during the study treatment period.~   "
196227|NCT00994877|"~     Methods:~      The study is an observational prospective trial that includes 150 patients 18 or older~     admitted to our icu because of severe sepsis or septic shock as defined by the American~     College of Chest Physicians/ Society of Critical Care Medicine consensus conference.~      Patients whose primary reason for hospital admission is sepsis or patients developing sepsis~     after elective invasive procedure will be included.~      Only patients with known former primary coagulation/hypercoagulability disorder wil be~     excluded.~      Procedure:~      Within 12 hours of admission to the intensive care unit (ICU) blood will be drawn for the~     following:~      Blood count, glucose, urea, creatinine, liver function tests, prothrombin time, partial~     thromboplastin time, Ddimer, fibrinogen and TEG (thromboelastography) assay will be~     performed.~      These blood tests will be also drawn on day 2 and 4 of admission. On day one, another 3 cc of~     blood will be drawn and frozen in -80 degrees for levels of coagulation factors: I, II, V,~     VII, VIII, IX, X, XI, XII, XIII, Antithrombin III, protein C, S.~      Demographic data will be collected according to patient chart, and the acute physiologic and~     chronic health evaluation (APACHE) II score will be assessed after 24 hours. Vital signs will~     be collected from monitors.~      Informed consent will be waved due to lack of any intervention and the general condition of~     patients unable to sign an informed consent.~      Control group will include 10 healthy individuals.~      End point:~      The primary end point is to determine the common hypercoagulable/coagulation disorders~     according to TEG.~      The secondary end point is to determine whether TEG results have prognostic implications on~     this group of severe septic patients.~   "
196228|NCT00994864|"~     The primary working hypothesis is that preoperative chemo-sensitivity testing using~     fluorodeoxyglucose positron emission tomography (FDG-PET) performed before and after one~     course of FOLFOX (folinic acid, fluorouracil, oxaliplatin) can identify the patients that~     will least likely have a significant benefit from adjuvant FOLFOX for stage III colon cancer.~     The benefit will be analyzed by correlating the preoperative FDG-PET uptake changes to the~     disease free and overall survival.~   "
196229|NCT00994851|"~     Primary Objective:~      To evaluate the clinical efficacy of Naturetti (capsules) , considering the following~     criteria:~        -  Evacuation frequency during the treatment and follow-up period~        -  Consistency of stools during the treatment and follow-up period~        -  Global evaluation, regarding increase in frequency of evacuation and shape of stools.~      Secondary Objective:~        -  Number of days without evacuation~        -  Proportion of evacuation with pain~        -  Proportion of evacuation with strain~        -  Proportion of evacuation with incomplete sensation~        -  Proportion of blocked stools~        -  Proportion of manual maneuvers to facilitate defecation~        -  Proportion of subjects that adhere to the diet recommended~        -  Proportion of the patients who have to use rescue medication~        -  Level of constipation improvement, according to the patient evaluation~        -  To evaluate clinical tolerability of the study medication by the continuous use~        -  To evaluate the occurrence of adverse events related to the study drug~        -  To identify any drug interaction.~   "
196230|NCT00994838|"~     The purpose of this study is to measure the effect of a reduced calorie diet intervention in~     new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin~     resistance.~   "
196231|NCT00994825|"~     Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or~     those undergoing major surgery, resulting in multiple organ damage with significant~     in-hospital and long-term morbidity and mortality, as well as prolonged hospital stay. In~     this setting the mortality rate is distressingly high despite improvements in intensive care~     treatment, but survivors have an acceptable quality of life.~   "
196232|NCT00994812|"~     The purpose of this study is to determine whether metformin may improve pregnancy rates, and~     decrease miscarriage rates and complications of pregnancy, such as toxemia and gestational~     diabetes, in women with polycystic ovary syndrome (PCOS).~   "
196233|NCT00994799|"~     This study investigates the hypothesis that ranibizumab injection given into the eye is an~     efficacious and safe treatment option applied for swelling of the macula (site of sharp~     vision) in diabetes.~   "
196234|NCT00994786|"~     This study will examine the efficacy of pregabalin (Lyrica) added to SRI treatment in OCD for~     individuals who have not responded or only partially responded to an adequate trial of SRI.~     Although SRIs have demonstrated efficacy in OCD in numerous placebo-controlled trials,~     response rates have been as low as 40%. Augmentation strategies would be beneficial to~     maximize treatment response in OCD.~      Pregabalin (Lyrica) is an anticonvulsant medication that appears to have a novel mechanism of~     action. It has been shown to enhance activity at gamma-amino-butyric acid (GABA) receptors as~     well as inhibit glutamate release. These two neurotransmitters systems have been implicated~     in the neurobiology of OCD.~      The study will consist of patients who have not attained full response to an SRI. The~     patients will be randomized in a double-blind fashion to augmentation with pregabalin~     (Lyrica) or placebo. The dose of study medication will be flexible, starting at 75 mg/day and~     increasing in 75 mg increments to a maximum of 600 mg/day, based on efficacy and any side~     effects. Patients' response to treatment will be measured by the Yale-Brown~     Obsessive-Compulsive Scale (Y-BOCS), the Montgomery Asberg Depression Rating Scale (MADRS),~     and the Clinical Global Impression Scale(CGI).~   "
196235|NCT00994773|"~     The investigators have shown robust in vitro anti-hepatitis B activity of simvastatin alone~     and synergistic activity with all four FDA-approved anti-hepatitis B oral drugs tested. The~     investigators propose phase 1 studies in 48 chronic hepatitis B human carriers who have never~     been treated before. Doses of drugs will remain at or below FDA-approved dosage levels for~     cholesterol lowering (simvastatin) or hepatitis B (tenofovir or entecavir). Arm 1 will have~     simvastatin monotherapy only. Arm 2 will combine simvastatin with tenofovir. Arm 3 will~     combine simvastatin with entecavir. For maximum safety, the 3 arms and the dose groups in~     each arm will be filled consecutively and not concurrently. The definition of efficacy for~     simvastatin alone will be a 1 log drop of hepatitis B virus in 14 days. Efficacy for~     combination of drugs will require a 2 log drop of hepatitis B virus in 14 days. Numerous~     safety tests and stop rules are noted in the protocol.~   "
196236|NCT00994760|"~     The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in~     cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP)~     attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study~     was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.~   "
196237|NCT00994747|"~     Flavor is the primary dimension by which young children determine food acceptance. However,~     children are not merely miniature adults since sensory systems mature postnatally and their~     responses to certain tastes differ markedly from adults. Moreover, emerging research has~     revealed that there are sensitive periods during infancy such that early flavor experiences~     serve to modify later responses to flavors and foods. The proposed study aims to investigate~     this important issue by using as a model system a class of infant formulas which are~     hydrolyzed protein based and thus have very pronounced and distinctive flavors which are~     unpalatable to older-aged infants and adults. This research was initiated because of~     anecdotal reports by pediatricians that although it is easy to introduce this type of formula~     to infants during the first months of life, it becomes extremely difficult to do so later in~     infancy. Indeed, recent studies in the investigators' laboratory provided the first~     experimental demonstration that infants younger than 4 months of age willingly accept~     substantial amounts of, and satiate while feeding, a novel, protein hydrolysate formula. In~     marked contrast, infants older than 4 months reject the protein hydrolysate formula and this~     rejection occurs within the first minute of a feed, a finding that strongly suggests the~     sensory qualities of the formula are responsible, at least in part, for this rejection.~     Moreover, this rejection is not evident when the investigators test older-aged infants with~     other unfamiliar, but non-hydrolysate, formulas. In other words, the rejection appears to be~     in response to a particular component or components of protein hydrolysate formulas. This~     shift in acceptability can be ameliorated by prior exposure. That is, if these formulas are~     introduced to infants within the first few months of life and are fed continuously, they~     remain highly acceptable throughout infancy and early childhood. These observations implicate~     a sensitive period during development, occurring somewhere before 4 months of age, during~     which exposure to a formula, which is unpalatable to adults and infants over 4 months of age~     without exposure, renders it acceptable and presumably palatable. To the investigators'~     knowledge, this is the clearest example of a sensitive period in the development of responses~     to foods and flavors in humans thus far identified.~      There is a paucity of information on whether and how the composition of formulas fed to~     infants influences their short-term feeding behaviors during the first few months of life.~     The primary objective of this longitudinal study is to determine the period during early~     infancy when exposure to the casein-hydrolysate formula, Nutramigen, renders it acceptable~     during later infancy. The study also aims to determine how early sensory experiences with~     formula impact upon food acceptance during infancy (8-9 months of age) and childhood. The~     investigators will also explore how variation in the genes that encode for taste receptors~     influence preferences for foods and other behaviors.~   "
196238|NCT00994734|"~     The primary aim of this study is to assess the acceptability of home-use mifepristone for~     termination of pregnancy among women who choose it and their providers. The investigators'~     secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost~     productivity, and to estimate the minimum proportion of women who choose home-use over clinic~     use of mifepristone.~   "
196239|NCT00994721|"~     Study Design： Adjuvant gemcitabine therapy has been shown to improve recurrence-free survival~     in pancreatic cancer underwent curative intent resection. This study is to evaluate whether~     combining concurrent chemo-radiotherapy can further improve the recurrence-free survival~     benefit of adjuvant gemcitabine chemotherapy in pancreatic cancer underwent curative~     resection.~      Research Objective and Study End Points~        1. Primary endpoint： The primary end point is disease free survival.~        2. Secondary endpoints： The secondary end points are to evaluate the overall survival,~          local and distant recurrence rate, and impact on quality of life after adjuvant~          gemcitabine with or without CCRT in curatively resected pancreatic cancer.~      Furthermore, the clinical, pathological and molecular prognostic factors in curatively~     resected pancreatic cancers will be evaluated.~   "
196240|NCT00994708|"~     Evaluate the prevalence of bronchial responsiveness (BHR) among patients with~     gastroesophageal reflux disease (GERD).~      Investigate correlation between bronchial reactivity and the severity of GERD, and similarly~     investigate the correlation between exhaled nitric oxide (NO) and the severity of GERD.~      Compare the effects of esomeprazole 40 mg twice daily and Nissen fundoplication on bronchial~     reactivity, exhaled NO, pulmonary function and quality of life.~   "
196241|NCT00994695|"~     Primary objective:~      To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days~     (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity~     between these age groups.~      Secondary Objectives:~        -  To estimate the incidence of common adverse events following immunization (AEFI) of GSK~          Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination~        -  To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23~          months post vaccination in 2-4, 5-14, 15-29 year age groups~      Study site:Two rural communities (Kebele) in Butajira district, Ethiopia.~      Methods:~        -  Phase II, open and parallel safety and immunogenicity trial.~        -  234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29~          years of age) were randomly selected from the demographic surveillance database and~          enrolled after screening and consenting.~        -  Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml~          subcutaneously.~        -  Blood samples for measuring SBA titres were collected at pre vaccination and on day 28~          (+6 days) post vaccination.~        -  Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, & 28.~        -  Primary end point was vaccine response defined as sero-conversion (in subjects initially~          seronegative) or a 4 fold increase (in subjects initially seropositive) in serum~          bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination~          day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28~          post vaccination.~        -  Secondary endpoints were incidence of general and local symptoms and other adverse~          events following immunisation during the post vaccination period day 0 to 28 and immune~          persistence on post vaccination month-11 and month-23.~      Results:~        -  No significant difference in the incidence of general or local AEFI was observed between~          the age groups~        -  The statistical analysis for the Immunogenicity data is in progress~   "
196242|NCT00994682|"~     Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver~     disease, which is a chronic liver disease associated with insulin resistance, impaired~     glucose intolerance, and hepatic fat accumulation. The thiazolidinedione pioglitazone~     improves glucose/lipid metabolism and histology in NASH by improving insulin resistance in~     the liver/peripheral/adipose tissues and reducing subclinical inflammation. The aim of this~     study is to assess the underlying mechanisms at the clinical and molecular level and the~     long-term efficacy and safety of pioglitazone in NASH in a multiethnic cohort of subjects~     (predominantly Hispanics, Caucasians and African-Americans - the most common ethnic groups~     locally) and examine the response including patients with normal glucose tolerance, impaired~     glucose tolerance or established type 2 diabetes mellitus (T2DM).~   "
196243|NCT00994669|"~     The long-term objective of this research is to develop a non-invasive approach for early~     assessment of which patients are at high risk for future development of skeletal muscle~     atrophy. The investigators hypothesize that the rate constant for the terminal portion of the~     isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine~     (D-3MH) provides an accurate measure of this increased risk and that this rate constant can~     be measured non-invasively from timed spot urine samples. In addition, the investigators~     hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal~     muscle proteins to a greater extent than a non-meat-containing meal.~   "
196244|NCT00994656|"~     Spine fusion is an involved procedure during which patients are at risk for significant~     intra-operative blood loss.This study will compare 2 ways of determining fluid status and~     response to fluid administration. One way is to measure the changes in the arterial wave form~     from the special IV that is usually placed in an artery (PPV). The second way is to use a~     non-invasive method of a finger probe that measures changes in the plethysmogram or the pleth~     variability index (PVI). No actual patient treatments will be based on these values during~     surgery.~   "
196245|NCT00994643|"~     This is a study to see if maintenance therapy with low dose interleukin-2 (IL-2) and~     rituximab can delay or prevent recurrences in patients with high risk Non-Hodgkin's Lymphoma~     (NHL). IL-2 is a naturally occurring cytokine in our immune system which may enhance the~     activity of a known therapeutic agent rituximab, a monoclonal antibody against CD-20, in the~     setting of NHL.~   "
196246|NCT00994630|"~     The purpose of this study is to determine expression of chaperones proteins from the~     endoplasmatic reticulum stress response system in bipolar I patients (manic phase) compared~     to healthy controls.~      Hypothesis: There is no difference in chaperones proteins expression between bipolar I manic~     patients and healthy controls~   "
196247|NCT00994617|"~     To test whether the current custom of initiating treatment for hypertension with a single~     drug is less effective in the short-term than initial combination therapy, and results in the~     eventual need for comparatively more antihypertensive drug therapy.~   "
196248|NCT00994604|"~     The purpose of this study is to examine whether broccoli sprout extract can effect lung~     function measurements in individuals with asthma and COPD.~   "
196249|NCT00994591|"~     Levels of cotinine, a biomarker for nicotine, have been found to be higher in infants and~     small children than adults. This pharmacokinetic study is designed to determine whether~     children metabolize cotinine differently than adults.~      Seventy-two healthy children between the ages of 2 months and 6 years will come with their~     mothers to SFGH GCRC for one approximately 9 hour visit. After being examined by a~     pediatrician, the child will be administered one dose of cotinine at .05 mg/kg.~      Saliva and urine samples will be collected prior to dosing and throughout the day to~     characterize the metabolism and excretion of cotinine. The investigators have previously~     shown that a ratio of 3'-hydroxycotinine/cotinine (3HC/Cot) in saliva correlates closely to~     nicotine metabolism.~      Following these one day hospital visits, a research assistant will visit the participants in~     their homes to collect urine and saliva samples at 1,2,3,7, and 10 days after the initial~     dose.~   "
196250|NCT00994578|"~     The overall goal of this study is to improve communication between patients with advanced~     cancer and their oncologists. A web-based communication intervention will be delivered to~     patients to help them to express their negative emotions and elicit empathic responses from~     their oncologists.~      The specific aims are to:~      AIM 1: Develop a web-based intervention that trains patients with advanced cancer to express~     their emotional concerns to their oncologists and to request emotional support during~     clinical encounters.~      AIM 2: Test whether this intervention can increase patient expression of emotional concerns~     and requests for emotional support, as well as improve patient affect by decreasing negative~     emotions.~   "
196251|NCT00994565|"~     The CoAct study is investigating a novel lifestyle intervention, aimed at the working~     population, with daily activity monitoring and distance counseling via telephone and secure~     web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle~     counseling on the level of physical activity in an occupational health setting. The purposes~     include also analyzing the potential effects of changes in physical activity on productivity~     at work and sickness absence, and health care costs.~   "
196252|NCT00994552|"~     This study is looking at whether there is a difference in outcomes using two different types~     of breathing support in those patients who have chronic respiratory failure (patients who~     under-breathe).~      There is little data to demonstrate which mode of ventilation is better in terms of~     physiological outcomes and outcome data relating to patient symptoms.~      We hypothesize that one type of breathing support: pressure support ventilation would be more~     comfortable for patients as it more closely matches a patient's own respiratory pattern and~     and so leads to improved adherence and consequent improvement in quality of life.~      Patients with respiratory failure will be randomly assigned to receive either pressure~     support ventilation or pressure control ventilation for the first 6 weeks and then cross-over~     to receive the mode not previously used for a further 6 weeks. They will have baseline data~     recorded and then be followed up after each 6 week block.~   "
196253|NCT00994539|"~     Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to~     examine the effect of food on absorption from the 30 mg tablet.~   "
196254|NCT00994526|"~     Colorectal cancer kills forty five people in France every day. Epidemiological studies~     suggest that two cases out of three could be prevented and show that processed meat intake is~     a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to~     find protective strategies, and to make compelling dietary recommendations.~   "
196255|NCT00994513|"~     The major objective of this study is to conduct a double-blind, placebo-controlled,~     randomized clinical trial to assess whether oral alpha lipoic acid supplementation will~     decrease cardiovascular disease and type 2 diabetes risk in obese subjects.~   "
196256|NCT00994500|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with bortezomib in treating young patients with refractory or recurrent solid~     tumors, including CNS tumors and lymphoma. Vorinostat and bortezomib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow~     to the tumor.~   "
196257|NCT00994487|"~     The purpose of this study is to compare female, preschool-aged children breastfed during~     infancy to female, preschool-aged children bottle-fed during infancy in their ability to~     adjust calorie intake in response to internal signals of hunger and fullness. Children and a~     parent will come to two sessions, with the children given drinks that are either high or low~     in energy, and then consume a lunch following the drink. The parent will be present during~     the lunch. Greater ability to self-regulate intake is demonstrated when less energy is~     consumed at lunch following the high energy drink as compared to the lunch following the low~     energy drink. Lunches will be videotaped so that parental feeding styles (i.e., how the~     parent interacted with the child during lunch) can be examined. The primary hypotheses are:~     1.) the exclusively breastfed children will have higher self-regulation ability than the~     exclusively bottle-fed children, and 2.) the mothers of the exclusively breastfed children~     will demonstrate a parental feeding style characterized by less control and restriction than~     the mothers (or parent primarily responsible for child feeding) of the exclusively bottle-fed~     children.~   "
196258|NCT00994474|"~     We previously published a comparative split-face study which has shown a significant, albeit~     moderate, effect of ablative fractional laser treatment. While indicating that a single~     session with fractional ablative lasers can be effective in the treatment of peri-orbital~     wrinkles, the trial also revealed substantial disagreement between the different end points~     (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a~     patient-related index it could not be included in the aforementioned split-face trial; the~     present study therefore attempts to further elucidate the patient-related benefit of a single~     fractional ablative laser treatment session as well as carefully analyse the respective~     correlations between the outcome parameters employed.~   "
196259|NCT00994461|"~     A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the~     incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.~   "
196260|NCT00994448|"~     Dr Keith Heinzerling, who is a doctor at UCLA, is doing a research study with Behavioral~     Health Services in the Lincoln Heights neighborhood of Los Angeles to find out if a~     medication called bupropion can help adolescents (age 14-21) reduce or stop using~     methamphetamine. Bupropion is a drug that is already on the market, which means it has been~     approved by the FDA, but it has not been approved to treat methamphetamine abuse. What the~     study is trying to find out is if bupropion helps people to stop using methamphetamine. The~     study lasts up to 14 weeks and involves visits to the BHS clinic in Lincoln Heights twice a~     week. The first two weeks involve completion of questionnaires and assessments, including a~     physical exam, a blood test, EKG (a test that checks for problems with the electrical~     activity of a person's heart), and a psychological interview, to see if you are eligible for~     the study. If you are eligible, then you will be assigned by chance to take either the~     bupropion pills or placebo pills, which are pills that look the same, but contain no~     medication. This type of study is called a double blind study because neither you nor any~     of the study staff will know which medication you are taking. During the 8 weeks of taking~     the pills, you'll visit the clinic to complete additional questionnaires and assessments, to~     provide urine samples for testing for methamphetamine, and for once a week drug abuse~     counseling. At the end of your treatment, you'll have another physical exam including blood~     tests and the same test on your heart and then we'll ask you to come to the clinic once a~     week for four weeks for follow-up assessments. You'll be compensated for time spent doing~     research activities and for returning empty medication packages. The total compensation~     possible is $332 in gift cards for places such as Target, iTunes, groceries, and gas.~      Your participation in the study is voluntary and deciding not to participate or deciding to~     stop participating at any time during the study is okay.~   "
196261|NCT00994435|"~     Insulin secretion and insulin sensitivity are related with an inverse, hyperbolic function,~     the so called disposition index, that shows the critical importance of the ß-cell dysfunction~     for the development of T2DM. A consequence of the hyperbolic relationship is that increased~     insulin resistance is compensated by up-regulation of insulin secretion, as it happens in~     obesity. However, when a defective insulin secretion in relation to insulin sensitivity takes~     place (i.e. reduced disposition index) then impaired glucose tolerance or type 2 diabetes~     develop. The investigators have recently demonstrated that bilio-pancreatic diversion~     determines a prompt reversibility of T2DM by normalizing peripheral insulin sensitivity and~     enhancing ß-cell sensitivity to glucose; these changes occur within few days after surgery,~     largely before changes in body weight occur. This operation may affect the entero-insular~     axis function, by diverting nutrients away from the proximal gastro-intestinal tract and by~     delivering incompletely digested nutrients to the ileum, thus abnormally stimulating the~     secretion of intestinal incretins. It has been shown that male Wistar rats undergoing three~     different types of small intestinal surgery, namely ileal transposition (either 10 or 20 cm~     of lower ileum transposed to mid-duodenum) or 85% jejuno-ileal bypass, showed a sustained~     post-operative reduction in food intake and a significant change in body weight gain. All~     experimental groups had a large increase in basal and meal-stimulated enteroglucagon, while~     the area under the curve of plasma levels of gastrin, gastric inhibitory polypeptide (GIP),~     insulin and blood glucose were significantly reduced. GIP is produced mainly in the duodenum~     and jejunum as shown in dogs .The aim of the present study is to investigate the intestinal~     site of production of incretins in response to intraluminal nutrients stimulation in order to~     establish the relationship between insulin resistance, insulin hypersecretion and different~     small intestinal segments in insulin resistance conditions, such as obesity and T2DM. To this~     purpose a mixed test meal will be infused in the duodenum, proximal jejunum or ileum and~     glucose uptake and insulin secretion studied, in relation to glucagon and incretin response.~     Studies are carried out in 20 obese subjects of both sexes, 10 of whom with type 2 diabetes~     and 10 with normal glucose tolerance.~   "
196262|NCT00994422|"~     The purpose of this study is to compare the safety and efficacy of a 0.5% ivermectin cream to~     a placebo in subjects infested with head lice when used in an at home environment.~   "
196263|NCT00994409|"~     The objective of this trial is to guarantee a follow-up of all stroke and transient ischemic~     attack (TIA) patients. With this follow-up assessment long term effects of therapy and~     prevention measures can be detected and monitored. It is part of quality assurance.~   "
196264|NCT00994396|"~     The investigators' project will study the effects of optimizing the vit D status of obese~     adolescents on markers of glucose metabolism and inflammation.~   "
196265|NCT00994383|"~     Characterize the steady-state pharmacokinetics of morphine after oral administration of~     Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to~     compare their pharmacokinetics to that of AVINZA.~   "
196266|NCT00994370|"~     This study is being done to investigate the influence of giving radiation to the liver on~     tumors involving the liver. Investigator is specifically looking at this effect on the blood~     vessels within the tumor. This effect will be measured by studying substances in the blood~     that the tumors produce and that cause blood vessels to grow. The effects seen on these~     substances may help design other treatments to improve the results of the radiation used to~     treat these tumors.~   "
196267|NCT00994357|"~     The purpose of the study is to investigate the effects of Real-time Continuous Glucose~     Monitoring on severe complications to pregnancy in women with diabetes.~   "
196268|NCT00994344|"~     The purpose of this study is to determine the non-inferiority in the efficacy of DRV/r~     (900/100 mg) monotherapy at 48 weeks versus LPV/r (400/100 mg) as simplification strategy in~     subjects with sustained viral suppression on stable PI or NNRTI-antiretroviral regimens.~   "
196270|NCT00994318|"~     Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using~     targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic~     kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).~   "
196273|NCT00994279|"~     RATIONALE: Yoga and wellness classes may reduce fatigue and improve mood, sleep, and quality~     of life in women receiving chemotherapy for breast cancer. It is not yet known whether yoga~     is more effective than wellness education for women with breast cancer who are undergoing~     chemotherapy.~      PURPOSE: This randomized phase II trial is studying a community-based yoga class to see how~     well it works compared with an educational wellness class for women with stage I, stage II,~     or stage III breast cancer undergoing chemotherapy.~   "
196274|NCT00994266|"~     The purpose of this study is to assess the efficacy of Diamel (dietary supplement)~     administration in the treatment of patients with type 2 diabetes receiving insulin therapy.~     The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.~     The estimated number of patients to be recruited and randomized for the study is 116. Daily~     insulin requirements, blood glucose (fasting and post-prandial) concentrations, glycosylated~     hemoglobin (HbA1c), triglycerides and cholesterol will be assessed at the beginning and after~     24 weeks of treatment.~   "
196275|NCT00994253|"~     The purpose of this study is to assess the effect of Tekturna (aliskiren), in combination~     with an ACE and calcium channel blocker in hypertensive patients diagnosed with Type II~     diabetes.~   "
196276|NCT00994240|"~     This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin~     (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no~     controls. Subjects meeting eligibility criteria are randomly divided into one of two~     treatment groups (ED&C x 1 cycle or ED&C x 3 cycles) using computer generated random numbers.~     One cycle of ED&C is defined according to standard technique currently employed. It involves~     scraping away the tumor with a curette (ring- shaped instrument) and then burning the~     curetted site with a small electric needle (electrodessication). During Visit 1, the surgical~     site is marked, local numbing medication is injected, and 1 or 3 cycles of ED&C is/are~     performed by board-certified dermatologists or a dermatology resident under the direct~     supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months~     after Visit 1) include skin evaluations by the physician who performed the ED&C. The lesion~     site is examined, measured, and photographed for clinical evidence of recurrence, as defined~     by a new lesion within the previously treated site. If there is evidence of possible tumor~     recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be~     biopsied using a shave procedure.~   "
196277|NCT00994227|"~     this study is to analyze and compare the ultrastructure of the retinal and vitreous plane of~     the epiretinal membrane and internal limiting membrane removed during macular surgery and to~     evaluate relation between the ultrastructure of the epiretinal membrane and internal limiting~     membrane and surgical outcomes.~   "
196278|NCT00994214|"~     The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin)~     injections at different doses of BIM 23A760 on growth hormone and insulin-like growth~     factor-1 levels in patients with acromegaly after 6 months of treatment.~   "
196279|NCT00994201|"~     The purpose of this study is to see if new techniques of measuring HNSCC tumors with magnetic~     resonance imaging (MRI) can help predict how well the tumors will respond to combined~     chemotherapy and radiation treatment. The investigators hope to find a reliable method to~     determine whether or not a patient's cancer is responding to chemo-radiation early in their~     treatment using an MRI, such that that cancer treatments could be tailored to the individual~     more effective in the future. The MRI techniques include dynamic contrast-enhanced magnetic~     resonance imaging (DCE-MRI), diffusion-weighted magnetic resonance imaging (DW-MRI), and~     magnetic resonance spectroscopy (MRS). Participants will be subjected to two sessions of MRI~     scans: one before the initiation of their regular treatment and the second before their~     second cycle of chemotherapy. Each scanning session will last approximately 45 minutes.~   "
196280|NCT00994188|"~     Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die~     every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000~     patients are registered with the Japan Organ Transplant Network (JOTN) with the hope for a~     renal transplantation. If the renal function is restored by transplantation, the quality of~     life (QOL) improves and more than 90% are reportedly comeback to their normal life activities~     and get relieved from the burden of dialysis. Furthermore, it can reduce the dialysis related~     medical cost by as much as 50%. However, only about 1,000 renal transplantation cases are~     annually carried out in Japan. Among them, 80-85% are living renal transplantations offered~     by family members or relatives, and the rest are from deceased donors.~      Due to the fact that the number of deceased donors are scarce and only living renal~     transplantations between the family members or relatives are currently allowed in Japan, the~     approximate waiting time to receive a renal transplantation is 16 years. For that reason,~     many patients travel abroad to receive a renal transplantation.~      There are reports that total nephrectomies are performed as a treatment for small size (4 cm~     or less) renal tumors, renal stones, ureteral tumors and ureteral strictures in many cases~     and that many of these nephrectomized kidneys can be successfully transplanted after surgical~     restoration with satisfactory results. However, due to the lack of necessary evidence it is~     currently not allowed in Japan.~      Therefore, the investigators planned the present clinical study to evaluate the curative~     efficacy (renal function, QOL) and safety (side effects, complications or occurrence of renal~     cancer) of living renal transplantations between family members and relatives with restored~     donor kidneys after the surgical removal or repairment of a small size (4 cm or less) renal~     tumor or renal stone, ureteral tumor or ureteral stricture, in order to acquire necessary~     clinical data for potential enrichment of the renal donor pool in Japan as well as to develop~     useful medical care for our patients who are on dialysis for many years due to the renal~     failure.~   "
196281|NCT00994175|"~     Background:~      - Individuals who have severe asthma that is not easily controlled by current treatments are~     in need of new treatments to prevent potentially life-threatening asthma attacks. Experiments~     in mice have found that a medication called pioglitazone hydrochloride (Actos ), which is~     used to treat patients with diabetes, may be effective for treating severe asthma.~     Researchers are interested in determining whether Actos is effective in improving the quality~     of life in subjects with severe asthma who continue to have symptoms despite maximum standard~     medical therapy.~      Objectives:~      - To assess the effectiveness of pioglitazone hydrochloride as a treatment for patients with~     severe asthma that is not controlled by standard treatments.~      Eligibility:~      - Individuals between 18 and 75 years of age who have been diagnosed with and treated for~     severe asthma for at least 1 year.~      Design:~        -  Potential participants will have a screening visit to determine eligibility for the~          study. The visit will involve breathing tests, chest x rays, heart and lung monitoring,~          and blood tests.~        -  Eligible participants will have a full medical history and will answer a series of~          questionnaires about their quality of life with asthma.~        -  Phase 1: Patients will record lung function and asthma symptoms morning and evening for~          4 weeks. At the end of this period, patients will be evaluated with breathing, allergy,~          and blood tests, as well as questionnaires. Patients will also provide a sputum sample.~        -  Phase 2: Patients will receive regular doses of either pioglitazone hydrochloride or a~          placebo for 16 weeks. Patients will return to the National Institutes of Health every 4~          weeks for tests.~        -  Phase 3: Wash-out period without study drugs for 4 weeks, similar to Phase 1.~        -  Phase 4: Patients will receive regular doses of either pioglitazone hydrochloride or a~          placebo for 16 weeks. Patients who received placebo will be given the study drug, and~          vice versa. Patients will return to the National Institutes of Health every 4 weeks for~          tests.~        -  Phase 5: Medications will be stopped, and patients will return to the National~          Institutes of Health 4 weeks later for final tests.~   "
196282|NCT00994162|"~     The aim of this evaluation is to assess the performance of the EZCare◊ product, in many~     different clinical environments, in order to gain a greater insight into the effects of this~     negative pressure wound therapy (NPWT) in a variety of wound types.~   "
196397|NCT00992654|"~     The new protocol will allow the patients enrolled on A4001050 to have continuous access of~     Maraviroc and the treatment will not be interrupted until the drug is commercially available~     in India.~   "
196283|NCT00994149|"~     Diazoxide is an oral hyperglycemic medication. Diazoxide has been proven effective for~     treating hypoglycemia in infants and children with some types of persistent hyperinsulinemic~     hypoglycemia. The mechanism of action results in decreased insulin secretion. One of the~     causes of hypoglycemia in infants of diabetic mothers occurs due to a transient~     hyperinsulinemic state postnatally. The investigators have clinical experience and success~     using diazoxide in their unit for patients with hypoglycemia not adequately managed with~     intravenous (iv) dextrose and enteral supplementation. In this randomized controlled study~     the investigators expect that by using diazoxide as the initial treatment for infants of~     diabetic mothers with asymptomatic hypoglycemia (blood glucose of 2.5 to 2.0mmol/L), the~     investigators will be able to decrease the number of infants requiring an intravenous by at~     least thirty percent.~   "
196284|NCT00994136|"~     Long-term central venous access devices are considered as safe for the administration of~     medication as chemotherapy, but are also used for blood sampling. For years these catheters~     have been locked with a heparin solution in order to avoid occlusion. However, no scientific~     evidence supports heparin locking when the device is not in use. Advanced technology as~     needleless caps and valved catheters and port reservoirs confirms this trend to use 'saline~     only' for locking these devices. Therefore the investigators hypothesize is that there will~     be no difference in proportion of occlusions and catheter related bacteremia in long-term~     venous access devices locked with 'saline only' versus with heparin.~   "
196285|NCT00994123|"~     A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung~     cancer (NSCLC).~   "
196286|NCT00994110|"~     The purpose of this study is to help us learn more about how to lower the patient's risk of~     the most common complications after their pancreas operation. After tumors are removed and~     the remaining part of the pancreas is connected to the intestine or closed, a leakage of~     pancreatic fluid may occur. This fluid may form an abscess (collection of pus) or fistula~     that would need to be drained. A fistula is a persistent leakage of pancreatic fluid that~     sometimes occurs after pancreatic surgery. Fistulas, leaks, and abscesses are complications~     that are seen in roughly every 15-20 patients out of every 100 that have pancreas surgeries.~     Complications like these extend the patient's stay in the hospital after surgery. These~     complications may require the patient's doctor to perform additional tests or procedures to~     treat them.~      The physical and emotional burden these complications place upon patients, as well as the~     financial cost to the health care system, can be great. The surgeons at Memorial~     Sloan-Kettering Cancer Center are conducting a study to determine if a drug, SOM230, can help~     reduce the rate of these complications. SOM230, also known as Pasireotide, is a drug that has~     been observed to reduce the rate of similar complications in other studies.~      The surgeon would like to compare the effects, good and/or bad, of SOM230 with placebo~     (solution without medication) to see if SOM230 reduces the rate of fistulas, leaks and~     abscesses.~   "
196287|NCT00994097|"~     The main objective of this study is to demonstrate superiority in progression-free survival~     (PFS) when NGR-hTNF is added to standard chemotherapy regimen (cisplatin/gemcitabine or~     cisplatin/pemetrexed) in locally advanced (stage IIIb with supraclavicular lymph node~     metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent~     non-small cell lung cancer (NSCLC).~   "
196288|NCT00994084|"~     The collaborative study is to determine the effectiveness of an after-school community-based~     program to prevent obesity among minority children.~   "
196289|NCT00994071|"~     Background:~      - An experimental drug called ABT-888 has been studied in combination with temozolomide (a~     type of chemotherapy) in adults who have certain kinds of cancer. ABT-88 has been shown to~     increase tumor sensitivity to temozolomide and improve treatment outcomes in people who have~     cancer. More research is needed to determine if this combination of drugs will work well as~     an effective treatment for children who have brain tumors. This will be the first time this~     combination has been studied in pediatric patients.~      Objectives:~        -  To determine the maximum doses of ABT-888 and temozolomide when given in combination in~          children with brain tumors.~        -  To learn how children metabolize and clear ABT-888 from their bodies so that appropriate~          doses of this medication can be recommended for future clinical trials of this drug.~        -  To learn what side effects may occur when ABT-888 and temozolomide are given together.~        -  To learn how certain tumors respond to this combination of drugs by studying the~          characteristics of these tumors in a laboratory.~      Eligibility:~      - Individuals less than 21 years of age who have been diagnosed with a cancer of the nervous~     system (including brain and brain stem tumors) that has not responded to standard therapy.~      Design:~        -  Before beginning the study, participants will have a full medical history and physical~          examination, and may also be required to have scans of the brain and spine or provide~          samples of cerebrospinal fluid.~        -  Treatment will consist of up to 13 28-day cycles of therapy, for a total of 52 weeks (1~          year). Participants will receive a dose of ABT-888 twice daily for 5 days, and will~          receive a dose of temozolomide once daily for 5 days, every 28 days. The morning dose of~          ABT-888 will be given 60-90 minutes before the dose of temozolomide.~        -  Participants will have routine blood tests at least once a week throughout the treatment~          cycles, and will have scans of the brain and spine performed as required by the~          researchers.~   "
196290|NCT00994058|"~     The objective is to test a novel paradigm for the inhibition of human preterm uterine~     contractions.~      The study hypothesis is that human preterm contractions can be safely inhibited with a weak~     electrical current provided by an electrical inhibition/uterine pacemaker device.~      Preterm birth is still a major problem. Current methods of preventing the uterine~     contractions of preterm are limited and associated with many side-effects affecting both the~     mother and baby. A reliable method of preventing preterm uterine contractions would be an~     important discovery. Such a method could eventually lead to a long-term goal of decreasing~     neonatal morbidity and mortality.~   "
196299|NCT00993941|"~     The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow~     mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and~     middle stage of liver cirrhosis on the basis of HBV infection. The evaluation of the efficacy~     includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST),~     total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ),~     collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1~     week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also~     observed simultaneously.~   "
196300|NCT00993928|"~     RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may~     help improve the sleep of cancer survivors. It is not yet known which home-based program is~     more effective in improving the sleep of cancer survivors.~      PURPOSE: This randomized phase II trial is comparing two home-based programs for improving~     sleep in cancer survivors.~   "
196301|NCT00993915|"~     In which CHD patients with high risk of CV complications are different doses of LIPRIMAR~     used? For this purpose, data on hyperlipidemia will be elicited over and above the basic~     nosographic and demographic data, concomitant diseases and cardiovascular risk factor.~   "
196291|NCT00994045|"~     Thoracoabdominal aneurysm (TAAA) repair is a major elective vascular operation associated~     with a large blood loss and potentially life-threatening clotting abnormalities. Theses~     clotting abnormalities are principally treated using fresh frozen plasma (FFP) (derived from~     human blood donations), the administration of which carries a number of risks including virus~     transmission (human immunodeficiency virus (HIV), hepatitis B, hepatitis C) and infection~     with variant Creutzfeld-Jacob disease (vCJD). FFP is no longer administered to children or~     high-usage adults in the UK because of the infection risk, and recently it was decided by a~     UK advisory body that the use of UK-derived FFP should cease.~      Fibrinogen concentrate is an alternative treatment option to FFP which is thought have less~     infection risk (purified, heat treated) and has been in licensed use for many years in other~     European countries. The investigators have been using fibrinogen concentrate recently in~     their department as an alternative to FFP with encouraging results.~      20 patients undergoing elective TAAA repair at The Royal Infirmary of Edinburgh will be~     randomly allocated to receive standard treatment (FFP) or fibrinogen concentrate as treatment~     for clotting abnormalities during their surgery. The investigators will take a number of~     additional blood samples which will provide valuable information about the pattern of~     clotting abnormalities during this type of operation. The investigators will also record~     blood loss and the number of allogeneic (derived from human donors) blood components~     transfused to the patient (red cells, FFP and platelets). Our primary objective is to assess~     the pattern of coagulation abnormalities in both groups. We will also examine whether the use~     of fibrinogen concentrate during TAAA repair avoids the need to administer FFP.~   "
196292|NCT00994032|"~     The purpose of this study is to determine whether percutaneous vertebroplasty is able to~     improve long-term quality of life in patients with pain secondary to osteoporotic vertebral~     fractures, compared to conventional medical treatment.~   "
196293|NCT00994019|"~     Recently human papillomavirus (HPV) has been recognized to cause some oropharyngeal (tonsil)~     cancer. But very little is known about oral HPV infection and risk factors. This study will~     evaluate how common oral HPV infection is, what sexual behaviors are associated with risk for~     infection, and how long infections tend to last.~   "
196294|NCT00994006|"~     The magnesium food content in the Western world is consistently reducing. Hypomagnesemia is~     common in hospitalized patients, especially in the elderly with coronary artery disease (CAD)~     and/or those with chronic heart failure. Hypomagnesemia is associated with increased~     incidence of diabetes mellitus, metabolic syndrome, mortality rate from coronary artery~     disease (CAD) and all cause. Magnesium supplementation improves myocardial metabolism,~     inhibits calcium accumulation and myocardial cell death; it improves vascular tone,~     peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and~     improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free~     radicals, improves human endothelial function and inhibits platelet function, including~     platelet aggregation and adhesion. The data regarding the absorption difference between~     supplemental magnesium oxide and magnesium citrate in humans is spare.~   "
196295|NCT00993993|"~     The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P)~     is multidisciplinary. The careful consideration of concerned families during the repetitive~     appointments required by these treatments show the importance of the psychological context~     and of the harmonious structuring of the parents-child relationships on the child's~     development. Yet the birth of a child affected by CL/P is a particularly stressing and~     traumatising event for the parents. The investigators' prospective, multidisciplinary and~     multi-centred research project aims to assess the psychological perceptions of parents of~     children affected by CL/P over the year following the birth and analyse the child's degree of~     psychological suffering as well as the parents-child relationships. The time of the first~     surgical intervention varies amongst the treatment centres. The investigators listed four~     centres that intervene at different times according to the more or less long waiting times~     between the child's birth and this first surgical intervention. The results obtained for each~     group will be compared to one another and according to two sub-groups: parents who found out~     about the CL/P through embryo diagnosis and those who found out at their child's birth. The~     mental and psychological dimension due to the malformation and its correction will be~     analysed in the parents group (importance of the prenatal diagnosis, relational development~     with the child, self-esteem, quality of life) but also in the child (likely distress and~     withdrawal symptoms).~   "
196296|NCT00993980|"~     The purpose of this study is to assess the effectiveness of qigong for the treatment of low~     back pain compared to a stabilizing exercise therapy.~   "
196297|NCT00993967|"~     This is an Extension study of the MICONOS main randomised placebo-controlled trial~     (NCT00905268), and open to those patients completing the main study. The scientific aim of~     this extension study is to monitor safety and tolerability of idebenone over two years in~     patients with Friedreich's Ataxia.~   "
196298|NCT00993954|"~     Radial head subluxation, also known as pulled elbow or nursemaid's elbow, is one of the most~     common upper extremity injuries in young children and a common reason for an emergency~     department visit.1 The injury typically occurs when a forceful longitudinal traction is~     applied to an extended and pronated forearm.2 Children with radial head subluxation are~     usually easily recognized by their clinical presentation and rapidly treated by a simple~     reduction technique involving either hyperpronation or supination and flexion of the injured~     arm.3-7~      Despite the relative ease of diagnosis and treatment, children with radial head subluxation~     often wait several hours in a pediatric emergency department for a reduction that takes only~     a few minutes.8 Such visits have direct health care costs and involve time and stress for the~     child and their family. While many factors are associated with parental and patient~     satisfaction in the emergency department, it appears that that early treatment or~     intervention and shorter waiting times correlate with patient and parent satisfaction.9,10 As~     well, patient satisfaction appears to be the same or better when emergency department care~     for minor injuries is provided by nurse practitioners compared to physicians.11-13~     Increasingly nurse initiated treatments and the use of medical directives and clinical~     pathways are becoming a focus in providing health care.14-17 While radial head subluxation~     treatment is an appropriate area to consider management by emergency department nurses, no~     studies have examined their role in the management of this common injury. Our study's~     objective was to examine whether triage nurses, trained in the use of a medical directive~     that taught recognition and treatment of radial head subluxation, could successfully reduce~     radial head subluxation at a rate similar to physicians. Given the practical constraints at~     the time of emergency department triage, this study was designed as a cluster randomized~     trial where the unit of randomization was a day and the patients on any given day were~     assigned to the nurse or physician arm for the entire day.~   "
196302|NCT00993902|"~     Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more~     than one dominant follicles (>16mm).~   "
196303|NCT00993889|"~     We would like to determine whether Virtual Reality (VR) analgesia continues to be effective~     for reducing pain when administered for a clinically relevant treatment duration over~     multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).~   "
196304|NCT00993876|"~     Cognitive deficits in major depression seem explicable by the well-recognized concept of~     impaired neuroplasticity in mood disorders. This concept initially emerged from preclinical~     evidence that antidepressants phosphorylate and therefore activate the cyclic AMP response~     element binding protein (CREB) that is essential for synaptic plasticity. Nevertheless, the~     question remains whether the activation of CREB by antidepressants is relevant for the~     remission of cognitive deficits in patients. We addressed this issue by investigating the~     cognitive improvement during treatment with either citalopram or reboxetine because these~     antidepressants are different in their capacity to increase phosphorylated CREB (pCREB).~     Besides the pharmacological treatment groups, another group of patients was treated~     exclusively with psychotherapy.~   "
196305|NCT00993863|"~     The objective of this study is to evaluate the analgesic efficacy and safety of ADL5859~     compared with placebo and an active control (ibuprofen) in subjects with acute dental pain~     after third molar extraction.~   "
196306|NCT00993850|"~     The study aims to evaluate a psychological intervention for individuals who suffer from sleep~     disturbance and bipolar disorder. We are hoping that this treatment will: (1) improve the~     quality of life of individuals with bipolar disorder who are suffering from sleep disturbance~     and (2) reduce the risk of, or help prevent, episodes.~   "
196307|NCT00993837|"~     Endoscopic thyroidectomy has been used to treat thyroid diseases in China. However, whether~     this technique is rational to treat thyroid carcinoma is still in controversy. The diagnosis~     of thyroid carcinoma is predominantly made according to intra-operative frozen section~     pathological examination in China. In this research, the investigators want to compare~     clinical index (blood loss, operation duration, number of lymph nodes dissected, complication~     rates, etc) between patients underwent endoscopic thyroidectomy ( total thyroidectomy) and~     those underwent conversion to open procedure. The investigators want to evaluate the~     technical feasibility of endoscopic thyroidectomy for treating thyroid carcinoma.~   "
196308|NCT00993824|"~     The purpose of this study is to obtain continuous glucose monitoring (CGM) data from~     individuals taking Welchol compared to placebo. The CGM data will determine the effect on~     glucose control of adding Welchol to an anti-diabetic medication regimen.~   "
196309|NCT00993811|"~     The purpose of this study is to evaluate the Shang Ring, a novel Chinese device for voluntary~     medical male circumcision, in order to improve the provision of male circumcision services~     for HIV prevention in Africa.~   "
196310|NCT00993798|"~     The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain~     control in patients undergoing elective arthroscopic shoulder surgery on the basis of~     pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening~     period up to 14 days and a treatment period 14 days with a long term follow up visit at 6~     months. The study will provide further data on safety.~   "
196311|NCT00993785|"~     To evaluate product performance and safety of the Catheter Design for the treatment of a~     single coronary lesion.~   "
196312|NCT00993759|"~     The purpose of this of this study is to determine if 3804-250A can prevent the common cold~     caused by the rhinovirus when applied to the hands. The study will also evaluate whether~     3804-250A can prevent rhinovirus infection or common cold illnesses.~      The study will also evaluate the safety of 3804-250A.~   "
196313|NCT00993746|"~     Will the technique of adding lidocaine to bupivacaine fasten the onset of bupivacaine alone~     for infraclavicular brachial plexus block in end-stage renal disease (ESRD) patient?~   "
196314|NCT00993733|"~     The prevalence of acute renal failure in intensive care is estimated at between 5 and 20%~     depending on diagnostic criteria retained. And half of patients require the use of~     hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis~     technique widely used in intensive care unit.~      The CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane,~     a blood circuit, a dialysate circuit and a feedback circuit.~      The implementation of a CVVHDF requires the use of large amounts of biological liquid~     essential to enable the purification of blood during its passage through the artificial~     kidney.~      The objective of this study is to assess time nursing work and the costs of each method.~   "
196315|NCT00993720|"~     The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on~     insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients~     with type 1 diabetes.~   "
196316|NCT00993707|"~     The purpose of the study is to evaluate the safety of administering repeated doses of CTX-100~     (formerly ETX-100) to subjects with smoking-related chronic obstructive pulmonary disease.~   "
196317|NCT00993694|"~     RATIONALE: Gathering information about how often methemoglobinemia occurs in young patients~     receiving dapsone for hematologic cancer or aplastic anemia may help doctors learn more about~     the disease and plan the best treatment.~      PURPOSE: This research study is looking at methemoglobinemia in young patients with~     hematologic cancer or aplastic anemia treated with dapsone.~   "
196318|NCT00993681|"~     The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine~     System to actively immunize against Enterotoxigenic Escherichia coli disease in a field~     setting.~   "
196319|NCT00993668|"~     The purpose of this trial is to assess the affect of Certolizumab Pegol (CZP) treatment on~     antibody response to T cell-independent and T cell-dependent immunizations using pneumococcal~     and influenza vaccines, respectively.~   "
196320|NCT00993655|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving~     them in different ways may kill more tumor cells. It is not yet known which combination~     chemotherapy regimen is more effective in treating patients with ovarian epithelial cancer,~     primary peritoneal cancer, and fallopian tube cancer.~      PURPOSE: This randomized phase II trial is comparing the side effects of three combination~     chemotherapy regimens and to see how well they work in treating patients with stage IIB,~     stage IIC, stage III, or stage IV ovarian epithelial cancer, primary peritoneal cancer, or~     fallopian tube cancer.~   "
196346|NCT00993317|"~     The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in~     combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in~     patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.~   "
196321|NCT00993642|"~     The long-term objective of this research is to understand the molecular mechanisms of~     acquired endocrine resistance in breast cancer. Identifying these mechanisms is critical to~     the implementation of novel therapeutic strategies that can target and overcome altered gene~     networks involved in controlling breast cancer progression. While patients with tumors over~     expressing HER1, 2, or 3 have been shown to have reduced survival, patients with those tumors~     which overexpressed HER4 (erbB4) had increased survival (Witton 2003).~      This is a non-randomized, single-arm, proof of principle trial. Selected are patients with~     advanced-stage breast cancer whose tumors are ER+, tamoxifen refractory. Histologically~     proven diagnosis of recurrent or metastatic breast cancer is advanced cancer for which there~     is no treatment available which would have a reasonable chance of cure. Treatment failure is~     defined as tumor progression after chemotherapy and tamoxifen therapy. Patients will be given~     five 30mg doses of HDAC inhibitor (LBH) over a period of two weeks. A dose will be taken on~     Days 1,3,5,8 and 10. Patients will have a diagnostic tumor biopsy prior to drug~     administration and a diagnostic biopsy within 48 hours (2 days) of the last dose. Primary~     endpoints are measured by biopsy of palpable tumor with immunohistochemical staining for~     ERBB4. Secondary end points include the evaluation of cell death, apoptosis, with~     immunohistochemical staining for DNA breaks by TUNEL assay.~   "
196322|NCT00993629|"~     This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone~     administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.~   "
196323|NCT00993616|"~     This phase II trial is studying how well giving belinostat together with carboplatin works in~     treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube~     cancer, or primary peritoneal cancer that did not respond to carboplatin or cisplatin.~     Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving belinostat together with carboplatin may kill~     more tumor cells.~   "
196324|NCT00993603|"~     The aim of this study is to investigate weather gradual weight loss achieved with healthy~     lifestyle changes influence hormonal factors affecting appetite and blood glucose control in~     obese people without presence of diabetes.~   "
196325|NCT00993590|"~     The primary aims are to test whether an asthma care management system (M-CHESS) delivered via~     a smartphone (cellular phone with internet access) can support low income teenagers (ages~     12-18) with significant asthma and can improve asthma control and reduce asthma-related~     emergency or urgent care visits and hospitalizations. Secondary aims include whether M-CHESS~     increases adherence to asthma control medication and reduces absenteeism from school, work or~     an event they wanted to attend.~   "
196326|NCT00993577|"~     To compare the efficacy of global postural reeducation (GPR) with static stretching exercises~     (SS) in the treatment of women with temporomandibular disorders (TMD).~      Physical therapy is of importance in the treatment of myogenic temporomandibular disorders~     (TMD). Both stretching exercise and global posture reeducation are equally effective in the~     treatment of TMD.~   "
196327|NCT00993564|"~     The investigators will determine if the MRI can be used to determine the temperature inside~     the brain. This is an important piece of information now that cooling the brain is being used~     to decrease brain damage in infants who had a decrease in brain oxygen or flow around the~     time of birth.~   "
196328|NCT00993551|"~     This trial is a randomised controlled trial with a parallel design taking place in centres~     across the UK, Scandinavia and Brazil.~      650 infants with a diagnosis of isolated cleft palate who are considered medically fit for~     operation at 6 months, and who meet the inclusion criteria, will be included in the trial and~     randomised to receive either:~        -  Surgery at age 6 months, OR~        -  Surgery at age 12 months.~      The main objective is to determine whether surgery for cleft palate, using a specified~     technique, at age 6 months, when compared to surgery using the same technique age 12 months,~     improves speech development. All infants will be followed up at age 12 months, 3 years and~     five years for the assessment of the primary outcomes(age 5) and secondary outcomes.~   "
196329|NCT00993538|"~     The main objective of this project is not only a better understanding of the human leukemic~     disease but also to find new anti-leukemic or improve existing ones. This study has, the~     following aims:~        -  To analyze the genetic and epigenetic regulation of the retinoic acid induced cascade~          which leads to the expression of TRAIL in blood cells of patients with acute leukemia.~          This study will be complemented by the analysis of global gene expression (DNA chips)~          and of the DNA methylation state, and by chromatin immunoprecipitation experiences.~        -  To determine the efficiency of inhibitors of enzymes responsible for the modification of~          chromatin (existing and new developments within the European consortium EPITRON~          coordinated by Dr Gronemeyer) as inducers of differentiation and / or apoptosis of~          leukemic blasts.~        -  To explore Ikaros genic and functional abnormalities (genomic deletions, mutations,~          abnormal transcripts and proteins) in acute leukemia. The aim is to determine if these~          abnormalities may play a prognosis role.~   "
196330|NCT00993525|"~     To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal~     injection of ranibizumab for the management of persistent new vessels associated with~     diabetic retinopathy.~   "
196331|NCT00993512|"~     This study is an open, non- randomized, phase I, dose-escalating study to evaluate the safety~     and tolerance of Amphinex based PCI of bleomycin in patients with local recurrent or~     advanced/metastatic, cutaneous or sub-cutaneous malignancies.~   "
196332|NCT00993499|"~     The primary objective of this trial is to identify the Maximum Tolerated Dose of BIBW 2992~     therapy when given continuously in combination with Sirolimus.~      The MTD will be based on the Dose Limiting Toxicity information collected during the first~     two cycles.~      Overall safety, pharmacokinetics and anti-tumour efficacy will be evaluated as secondary~     objectives.~   "
196333|NCT00993486|"~     The purpose of this study is to determine the maximum tolerated dose and evaluate the safety~     of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem~     cell transplant from a related, haploidentical donor, in patients with severe hematologic~     malignancies.~   "
196411|NCT00992472|"~     The purpose of this study is to compare prochlorperazine plasma concentrations produced after~     administration of the test formulation with those produced after administration of a marketed~     reference product.~   "
196334|NCT00993473|"~     The primary study objective was to compare the rate of all hypoglycemia (composite outcome~     of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous~     glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG),~     low FSBG readings performed at other times) between children treated with Lantus (insulin~     glargine) and Neutral Protamine Hagedorn (NPH) insulin.~      Secondary objectives were to compare insulin glargine and NPH in terms of:~        -  rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal~          symptomatic, and severe nocturnal symptomatic hypoglycemia~        -  HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment~        -  percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment~        -  average blood glucose over whole trial and at end of trial, as estimated by continuous~          glucose monitoring (CGM), and blood glucose variability~   "
196335|NCT00993460|"~     Research has shown that fat stored within muscles affects the muscle's sensitivity to insulin~     and ability to handle blood glucose. The purpose of this study is to examine the effects of~     weight loss surgery-induced caloric restriction on the accumulation and types of fats within~     skeletal muscle, as well as the effects of such caloric restriction on insulin sensitivity~     and inflammatory responses in skeletal muscle. The investigator proposes that caloric~     restriction will result in decreases in diacylglycerols enriched with saturated fat and~     increases in diacylglycerols enriched with monounsaturated fats.~   "
196336|NCT00993447|"~     Primary objectives:~        -  To describe the immune response to each dengue serotype before and after each~          vaccination with sanofi pasteur's CYD dengue vaccine.~        -  To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.~   "
196337|NCT00993434|"~     The purpose of the research is to learn whether written materials or handouts that are given~     to parents are helpful in changing knowledge or behavior.~   "
196338|NCT00993421|"~     The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604~     or sibutramine alone in the treatment of obesity.~   "
196339|NCT00993408|"~     This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study~     followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible~     subjects will undergo an open-label, single-dose acute hemodynamic study with~     ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive~     either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind~     study can enter the open extension study (separate protocol) and receive administration of~     ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.~   "
196340|NCT00993395|"~     Substance-using adults are admitted to hospital for medical complication from their drug and~     alcohol use at very high rates; yet, their care is often defined by low rates of referral to~     addiction treatment programs and recidivism. In 1997, we instituted an integrated~     medical-substance use treatment program at Johns Hopkins, the First Step Day Hospital,~     designed for intensive post-acute care of previously hospitalized substance using adults. We~     have shown that patients with dual diagnoses admitted to First Step more often complete their~     course of medical care and stay in recovery longer than patients not admitted to First~     Step.(1;2) On discharge from First Step, patients are medically stable and drug-free. Their~     substance abuse care is transferred to an out-patient substance abuse treatment facility and~     their medical care is transferred to their primary care provider. Unfortunately, many~     patients are lost to follow-up during this transition. We believe that a peer mentor-based~     disease management program (PM) can provide continuity of care that begins in First Step and~     continues after discharge thereby increasing the proportion of patients who remain in~     treatment for their addiction and medical conditions. Peer mentors are persons from the~     target community who have been in recovery for 5 or more years. In cooperation with patients~     and providers, peer mentors improve the integration of care, quality of care, and access to~     healthcare services. This pilot study will test the effectiveness of a peer mentor-based~     disease management program. The specific aims are to compare the impact of the PM~     intervention verses enhanced usual care on outcomes in three domains (1) medical/psychiatric~     health status, (2) addiction recovery, and (3) social resource acquisition. If successful,~     this study will provide evidence supporting a larger randomized controlled trial of the~     impact of field workers on post-acute care among patients with dual diagnoses.~   "
196341|NCT00993382|"~     The Primary objective was to assess the efficacy of Celivarone for the prevention of~     Implantable Cardioverter Defibrillator (ICD) interventions or death.~      Secondary objectives were:~        -  To assess the tolerability and safety of the different dose regimens of Celivarone in~          the selected population.~        -  To document Celivarone plasma levels during the study.~   "
196342|NCT00993369|"~     This is a proof of principle study that investigates heart rate variability differences in~     fetal and neonatal life in a longitudinal study design and compares two subject groups,~     offspring conceived using in-vitro fertilization and conceived naturally.~   "
196343|NCT00993356|"~     Previous studies addressing preoperative somatostatin analogs (SSA) treatment and subsequent~     surgical cure rates are conflicting, reporting a benefit, or no difference between groups.~     And most reported studies were rather small and were made in retrospect, we conducted a~     prospective, randomized study to investigate whether 4-month preoperative lanreotide~     treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with~     macroadenomas. The investigators also aimed to investigate whether there were differences in~     the incidence of surgical complications, and duration of neurosurgical hospital stay.~   "
196344|NCT00993343|"~     To evaluate if rapamune + tacrolimus immunosuppressive prophylaxis is better than the~     established therapy using cyclosporine and methotrexate, a Nordic prospective multicenter~     randomized study will be performed. Patients will be randomized to treatment with rapamune~     combined with tacrolimus, or the established therapy using cyclosporine and methotrexate.~   "
196345|NCT00993330|"~     The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein~     and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of~     lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the~     MP before reaching the photo receptors it absorbs a significant portion of short-wavelength~     light. There is evidence that these absorbing properties of the MP as well as the ability of~     inactivating highly reactive oxygen species are protective for the retina.~      Measurement of macular pigment is difficult and the investigators have recently proposed a~     way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There~     is increased interest in these measurements in the recent years, because a number of studies~     has provided evidence that low fruit and vegetable consumption increases the risk of age~     related macular degeneration (AMD). The present study investigates MP optical density (OD) in~     healthy volunteers and is used to form a database.~      Furthermore the nutritional habits and the influence on MP density will be evaluated.~   "
196412|NCT00992459|"~     This was a randomized, active-controlled, double-blind, cross-over study designed to enroll~     subjects with UCDs who are being treated with NaPBA.~   "
196348|NCT00993291|"~     In this study the investigators will evaluate the effect of both low and high frequency Deep~     Brain stimulation of the subthalamic nucleus (STN) in Parkinson's patients who have noted a~     change in their walking. The investigators' hypothesis is:~        1. Stimulation at 60 Hertz (Hz) is associated with improved gait with increased stride~          length and faster time on the Stand walk sit test.~        2. There is no worsening of the Unified Parkinson's Disease Rating Scale (UPDRS) at 60 Hz.~   "
196349|NCT00993278|"~     The purpose of this research is to assess the effects of a low-carbohydrate (modified Atkins)~     diet versus a low fat (Heart Healthy) diet on cardiovascular health.~   "
196350|NCT00993265|"~     Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with~     trichotillomania can experience significant impairment due to peer teasing, avoidance of~     activities (such as swimming and socializing), difficulty concentrating on school work and~     medical complications due to pulling behaviors. Despite the fact that trichotillomania has a~     childhood onset, no randomized, controlled trials have been completed in childhood~     trichotillomania.~      Research in adults with trichotillomania has demonstrated that most commonly currently~     prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake~     inhibitors) is ineffective in treating this condition. By contrast, randomized controlled~     trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral~     treatments such as Habit Reversal Therapy.~      The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric~     trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign~     side-effect profile.~   "
196351|NCT00993252|"~     Each year, Canadian emergency department physicians treat 600,000 patients with head injury.~     Many of these are adults with minor head injury, i.e. loss of consciousness or amnesia and~     a Glasgow Coma Scale (GCS) score of 13-15. Only 6.2% of these minor patients have some~     acute injury on computed tomography (CT scan) and only 0.5% have an epidural hematoma~     requiring surgery. Among Canadian teaching hospital emergency departments, we have shown a~     fourfold variation in use of CT and that a small but important number of intracranial~     hematomas are missed at the first visit.~   "
196352|NCT00993239|"~     A Phase 1 open-label, non-randomized dose escalation study to determine the maximum tolerated~     dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711).~   "
196353|NCT00993226|"~     The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain~     control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and~     safety evaluations. The study duration consists of a screening period up to 14 days and a~     treatment period 14 days with a long term follow up visit at 6 months. The study will provide~     further data on the efficacy and safety of the product.~   "
196354|NCT00993213|"~     Liposuction surgery is common, yet animal and limited human data suggest that fat returns~     when removed. This study was designed as a 1-year randomized-controlled trial of suction~     lipectomy versus no intervention to determine if adipose tissue is defended, and if so to~     determine the anatomic pattern of redistribution.~   "
196355|NCT00993200|"~     Warfarin is the most commonly used oral anticoagulant medicine (blood thinner). Although this~     medicine works well, it is difficult to know how much medicine a patient needs. Many things~     affect how much medicine a patient needs and doses can be very different from patient to~     patient. It is important for patients to get the right dose to prevent clotting or bleeding~     problems that can happen with this medicine if the dose is too low or too high. These~     problems can be life-threatening. To help find the right dose, patients on warfarin must have~     frequent blood tests to measure how well the medicine is working. The investigators know~     differences in people's genes can affect how much warfarin medicine someone needs, but they~     don't yet know with certainty how to use this information in making patient care decisions.~     The hypothesis of this study is that using a patients warfarin related genetic information~     incorporated into a computer algorithm to be used by a warfarin provider will lead to better~     warfarin management compared to usual care.~   "
196356|NCT00993187|"~     This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®),~     MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary~     hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior~     reduction in HbA1c (mean change from baseline) compared to glimepiride.~   "
196357|NCT00993174|"~     Adult patients requiring surgery for esotropia will be randomized to surgery under topical~     anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic~     procedures will be compared. Motor and sensory outcome of the two treatment groups will also~     be compared.~   "
196358|NCT00993161|"~     The aim of this study is to evaluate different devices to quantify upper limb function~     (Motriplate) and strength (Myogrip, Myopinch) in non-ambulatory patients with neuromuscular~     disorder. Motriplate measures the ability of the patient to reproduce a repetitive movement~     of the wrist to push two 5cm*5cm targets during 30 seconds. One hundred patients aged 8-30~     years and 60 controls will be evaluated during twelve months (M0, M6 and M12) with theses new~     tools, and results will be compared to other testing, such as wrist, grip and pinch strength,~     taping, MFM measurement, and self evaluation of hand ability.~   "
196359|NCT00993148|"~     The objective of this study is to evaluate the safety and efficacy of a novel combination~     antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in~     treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in~     treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy~     with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.~   "
196360|NCT00993135|"~     RATIONALE: Gathering information about how often kidney dysfunction occurs in children and~     young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn~     more about the disease and plan the best treatment.~      PURPOSE: This research study is looking at kidney dysfunction in children and young adults~     who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic~     leukemia.~   "
196361|NCT00993122|"~     The results of antiviral therapy in patients with recurrent hepatitis C after liver~     transplantation are lower than standard. Ribavirin has immune-modulating effects and seems to~     be crucial to optimize viral treatment. The aim of this multicenter controlled study is to~     examine the effect of Ribavirin pre-treatment preceding the combination therapy with~     peginterferon plus ribavirin on the sustained virological response.~   "
196362|NCT00993109|"~     This will be a multi-center, prospective, randomized, open-label, parallel design, two arm~     comparator trial. In the proposed study, the investigators will compare low-dose combination~     therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with~     respect to their blood pressure-decreasing effects in patients with essential~     hypertension.The study consists of a screening visit, followed by randomization and~     administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or~     Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP~     and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.~   "
196363|NCT00993096|"~     This trial was conducted in Europe. The aim of this clinical trial was to evaluate the~     pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at~     three therapeutically relevant doses in subjects with type 1 diabetes.~      The trial is designed as a four period, incomplete block cross-over trial where the trial~     participant will be randomised to a treatment sequence by which the subject will receive two~     matched dose levels of NN5401 and biphasic insulin aspart, respectively.~   "
196364|NCT00993083|"~     This is a Phase IIa open label, non placebo controlled, non-randomised controlled challenge~     study. The primary objective of this study is to assess the safety of a new influenza~     vaccine, MVA-NP+M1, when administered as a single dose to healthy volunteers.~      Initially two volunteers will be vaccinated and challenged with Influenza, followed by~     vaccination of a further 12 volunteers and an Influenza challenge of those 12 along with 12~     non-vaccinated controls.~   "
196365|NCT00993070|"~     Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical~     capsaicin has been used to treat the pain, but there is no data in lower concentration. This~     is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic~     polyneuropathy.~   "
196366|NCT00993057|"~     What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention~     for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients~     undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing~     craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to~     every hour will help them reach target glucose levels faster and maintain them more~     efficiently with the same insulin protocol.~   "
196367|NCT00993044|"~     This phase I study is designed to determine the maximum tolerated dose of Irinotecan given~     intravenous for 5 days every 3 weeks in combination with fixed doses of Vincristine,~     Temozolomide and Bevacizumab (VIT-B) in patients with refractory solid tumors.~   "
196368|NCT00993031|"~     This study is an open-label, single site, randomized controlled trial comparing protease~     inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected~     pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is~     designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will~     have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART~     regimen. The primary study endpoint of the study is placental malaria. This study also~     enrolls the infants of these women at the time of delivery.~   "
196369|NCT00993018|"~     The purpose of this study is to evaluate the analgesic efficacy, safety and tolerability of~     multiple doses of JNJ-42160443 when administered as a single, subcutaneous injection every 28~     days to patients with diabetic painful neuropathy (a disease condition in diabetic patients~     that affects all peripheral nerves including pain fibers, motor neurons and the autonomic~     nervous system).~   "
196370|NCT00993005|"~     The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort)~     usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind~     placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons~     to be recruited and randomized for the study is 90.~   "
196371|NCT00992992|"~     The primary efficacy endpoint of this study is to determine the duration of response of the~     sequential administration of Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP for~     patients with previously untreated Mantle Cell Lymphoma (MCL). The secondary efficacy~     endpoints for this study are to determine the response rate, confirmed response rate,~     complete response rate, confirmed complete response rate, duration of response for confirmed~     responders, duration of response for complete responders, duration of response for confirmed~     complete responders, progression-free survival, time to treatment failure, and the predictive~     value of detection of minimal residual disease by molecular techniques on response duration.~     The pharmacokinetic endpoint is to determine the total body residence time of Iodine-131~     Anti-B1 Antibody following the dosimetric dose. The safety endpoints are to determine the~     incidence of adverse experiences, hematologic toxicity, (e.g., nadir, time to nadir, and time~     to recovery), use of supportive care, percent of patients converting to human anti-murine~     antibody (HAMA) positivity, the effects of Iodine-131 Anti-B1 Antibody on the growth and~     function of hematopoietic progenitor cells, and survival of patients with previously~     untreated MCL treated with Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP.~   "
196372|NCT00992979|"~     In Canada, Addiction Prevention and Treatment Service's (APTS) offer programs specifically~     designed to help people withdrawal from psychoactive drugs. While participants of withdrawal~     management (Detox) programs generally reach their goals, the process is a difficult one often~     exacting an emotional and physical toll. Troublesome symptoms of withdrawal from psychoactive~     drugs may include anxiety and sleep disturbances. If untreated these symptoms can lead to~     discontinuation of withdrawal and /or affect the introduction of cognitive-behavioral and or~     motivational therapy components of Detox programs. In Detox the symptoms of withdraw are~     managed pharmacologically. Pharmacological tools for managing anxiety and sleep disturbances~     exist and while effective and safe, in many clinical settings, have limitations and liability~     in the addiction treatment setting. To address these concerns APTS has incorporated~     non-pharmacological anxiety management practices into its programs. Prominent among these is~     therapeutic massage (chair massage in the Swedish tradition). While therapeutic massage has~     been shown to reduce state and trait anxiety in a variety of clinical settings, no previous~     study has assessed its anxiolytic or sleep promoting efficacy in an addiction treatment~     setting. In keeping with ATPS's policy on evidence-based practice, evidence in support of~     this practice is now required.~      Research Objectives: We propose to test the Hypothesis: Therapeutic Massage is an effective~     therapy for managing withdrawal-related anxiety and for improving sleep effectiveness in~     patients withdrawing from psychoactive drugs. Our specific objective is to perform a~     randomized controlled trial (RCT) to determine whether therapeutic massage is effective in~     comparison to relaxation control treatment in reducing the levels of state and trait anxiety~     associated with withdrawal and in promoting sleep efficiency.~      Research Design: A RCT of the effects of therapeutic massage will be conducted on 80 patients~     (ages 18-65) attending an APTS Detox program. Patients will be assigned to 1 of 2 treatment~     groups (n=40/group) and will receive either: therapeutic massage or relaxation control~     treatment once a day for 3 consecutive days. Anxiety, state and trait, will be measured pre~     and post each treatment through a standardized tool and physiologic measures (heart rate &~     blood pre(state and trait) and sleep efficiency will be determined through actigraphy and~     daily sleep logs.~   "
196375|NCT00992940|"~     Awake craniotomy for removal of brain tumour is performed because the tumour may be located~     close to areas of the brain that control specific functions such as movement or speech. Local~     anaesthesia (freezing) and sedation are required to make the patient comfortable and free of~     pain, but also to be able to cooperate for testing of brain function (speaking, moving) in~     order to preserve these areas while removing the brain tumour. The patient will be~     administered routine anesthetic drugs (sedatives (propofol) and pain killers (remifentanil)).~     The amount of sedation and analgesia (pain killer) is individually tailored to each patient~     as each person has different requirements. The usual way to give these medications is by the~     anesthesiologist assessing pain level, watching the patient and monitoring blood pressure and~     heart rate. Another way to give this medication is now available. This is with a special~     device, known as a patient-controlled analgesia pump (PCA). This device allows the patient to~     push a button to give pain medicine through an intravenous line and is frequently used for~     pain treatment after surgery and for other types of procedures. This device may be helpful~     during awake craniotomy, as it would allow patient-controlled administration of pain medicine~     and relaxing medicine whenever required. The amount of medication can be increased by more~     presses of the pump. At all times during the operation, the anesthesiologist will monitor the~     patient.~   "
196376|NCT00992927|"~     The purpose of the study is to compare the efficacy of intra-articular hydraulic distension~     (IHD) for the treatment of painful stiff shoulders between capsule-rupturing and~     capsule-preserving IHDs.~   "
196377|NCT00992914|"~     This study is being done to determine whether stellate ganglion injection with local~     anesthetic (the study procedure) can reduce the number and severity of hot flashes in women~     who have hot flashes.~      Hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue~     and irritability during the day. Hot flashes are the most common reason that women seek~     hormonal therapy. However, for many women, including breast cancer survivors, this is rarely~     an option, and these women seek alternatives to hormonal therapy to treat hot flashes.~      The study procedure has been in clinical use for more than fifty years in treating certain~     disease states and chronic pain. The study procedure has not been used to relieve hot flashes~     and the use of the study procedure with local anesthetic for the reduction of hot flushes is~     considered experimental.~   "
196378|NCT00992901|"~     RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM)~     immediately after surgery before any significant weight loss. In addition, a growing number~     of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several~     years following their surgery. While the mechanisms by which RYGB improves glucose metabolism~     or alters islet cell function in patients after RYGB are not understood, recent studies~     suggest that increased secretion of GI hormones, primarily glucagon-like peptide 1 (GLP-1),~     as well as alteration in neural activity may contribute to enhanced insulin secretion in~     general, and to a greater extent in patients with hypoglycemia. The proposed research is~     designed to address the role of RYGB on insulin secretion by evaluating the contribution of~     stimulatory factors (neural and GI hormone) on islet cell function and the islet cell~     responsiveness to the physiologic stimulatory factors, in RYGB patients with and without~     hypoglycemia and non-operated controls.~   "
196379|NCT00992888|"~     The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated~     immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect~     of Liver assist (liver dialyses) intervention on these parameters in patients with severe~     alcoholic hepatitis.~   "
196380|NCT00992875|"~     Training in mindfulness, the non-judgmental observation of experiences as they arise in the~     present moment, has been increasingly and successfully applied to the treatment of normative~     stress conditions and mental disorders. Yet, the neurological mechanisms that underlie the~     reported improvements are still largely unknown. This longitudinal study will investigate the~     influence of mindfulness training on a key underpinning of mental health, namely emotion~     regulation, and its associated brain activity. Healthy participants will be randomly assigned~     to either a validated eight week Mindfulness-based stress reduction (MBSR) program or to a~     control condition. In a pre-post investigation, participants' subjective reactions to~     aversive emotional stimuli (affective facial expressions) will be assessed, as will the~     associated brain activation using functional magnetic resonance imaging (fMRI). The~     investigators hypothesize that after the training the MBSR participants will rate the~     pictures as less aversive compared to control participants. Furthermore, the MBSR~     participants will show a patter of brain activation indicative of improved emotion~     regulation, relative to control participants. Finally, the effect of MBSR on the gray matter~     structure of the brain will be investigated.~   "
196381|NCT00992862|"~     The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg~     tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz~     Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under~     fasting conditions.~   "
196382|NCT00992849|"~     The purpose of the current study is to assess the efficacy and safety of the inhibitory~     effect of bevacizumab (Avastin) with different routes including topical and subconjunctival~     application on corneal neovascularization in the human eyes.~   "
196383|NCT00992836|"~     Children and people infected with HIV are particularly susceptible to influenza infections.~     This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus~     in children and youth infected with HIV.~   "
196384|NCT00992823|"~     Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the~     mean life of red blood cells compared to weekly supplementation, in reducing the prevalence~     of preschool anemia.~      Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old~     were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous~     sulfate during a 10-month intervention period. Group 1 received once weekly supplementation~     and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one~     month of supplementation (20 workdays) and four months without supplementation.~   "
196465|NCT00991770|"~     The purpose of this study is to assess the feasibility and efficacy of massage therapy for~     reducing pre-operative anxiety and post-operative pain among predominantly low income~     minority cancer patients undergoing surgical placement of a Port-a-Catheter.~   "
196466|NCT00991757|"~     The purpose of this open-label extension study is to demonstrate that RWJ-333369 is safe as~     long-term add-on treatment of partial onset seizures.~   "
196385|NCT00992810|"~     The ultrasound guided supraclavicular block is a peripheral nerve block which is considered~     safe, has a fast onset, is dense and provides complete block of the nerves supplying the~     hand, forearm and arm. However retrospective studies done at Toronto Western Hospital have~     highlighted the fact that most commonly the ulnar nerve fibres (responsible for sensations in~     the ring finger, little finger and the corresponding part of hand), sometimes escape this~     block and need additional supplementary block at a distal peripheral nerve site. It is a~     confusing fact since all nerve fibres are compactly arranged in a sheath at the~     supraclavicular level. The local anaesthetic agent at this level should be equally~     distributed among all nerve fibres. The purpose of this study is to compare two different~     approaches (medial and lateral) adopted by our clinicians to perform this block and to test~     the effectiveness of each approach for successful ulnar nerve fibre blockade.~   "
196386|NCT00992797|"~     The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of~     vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main~     hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from~     supplementation with cholecalciferol in sufficient doses to optimize serum levels.~   "
196387|NCT00992784|"~     The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine.~     Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the~     same vaccine for the third time. For this study the masking is observer-blind for elderly~     subjects and open for young adult subjects.~   "
196388|NCT00992771|"~     Spinocerebellar ataxia (SCA) is a group of inherited disorders characterized by cerebellar~     degeneration leading to imbalance, incoordination, speech difficulties and problems with~     walking. Recently, individual case reports have suggested that varenicline, a drug used in~     smoking cessation, produces substantial improvement in patients with several inherited~     ataxias. A modest response was noted in 5 patients with SCA, suggesting that it is~     potentially efficacious in this disorder as well. Although this agent is available for~     off-label use, the severe side effects noted with its use and the lack of long-term toxicity~     data demand that it be systematically assessed. The present study will test whether~     varenicline is safe and potentially efficacious in a heterogeneous cohort of adults with SCA.~   "
196389|NCT00992758|"~     This is a phase I, dose escalation, open-label, multicenter study of iodine-131 Anti-B1~     Antibody for patients with non-Hodgkin's lymphoma (NHL) who have more than 25% bone marrow~     involvement with NHL. Prior studies with Iodine-131 Anti B1 Antibody for the treatment of NHL~     have excluded patients with more than 25% bone marrow involvement with NHL. To be eligible,~     patients must have been previously treated and failed to achieve an objective response on or~     relapse during or following their last treatment.~      Patients will undergo two dosing phases while on study. In the first phase, termed the~     dosimetric dose, patients will receive 450 mg unlabeled Anti-B1 Antibody infused over 1~     hour or longer followed by 35 mg of Anti-B1 Antibody of which 1-2 mg has been labeled with 5~     mCi of Iodine-131 infused over 20 minutes. Whole body camera scans will be obtained on Day 0,~     Day 2, 3, or 4, and Day 6 or 7 following the dosimetric dose. Using dosimetric data from~     three imaging time points, a patient-specific dose of Iodine-131 Anti-B1 Antibody to deliver~     the desired total body dose of radiotherapy will be calculated. In the second phase, termed~     the therapeutic dose, 450 mg Anti-B1 Antibody will be infused over 1 hour or longer~     followed by 35 mg of Anti-B1 Antibody labeled with the subject-specific dose of Iodine-131 to~     deliver the desired total body radiation, infused over 20 minutes. The dose escalation will~     be initiated at 45 cGy and will be increased in 10 cGy increments until the maximum tolerated~     dose (MTD) is reached.~      Patients will be treated with either saturated potassium iodide, Lugol's solution, or~     potassium iodide tablets starting at least 24 hours prior to the infusion of the dosimetric~     dose and continuing for 14 days following the last infusion of the therapeutic dose.~      The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti B-1~     Antibody in patients with previously treated NHL having more than 25% bone marrow involvement~     with lymphoma. Secondary endpoints include assessment of response rate, duration of response,~     relapse-free survival, time to treatment failure, safety, and survival.~   "
196390|NCT00992745|"~     This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and~     ProstaScint® (111-In-capromab pendetide)in patients with metastatic prostate cancer. Eligible~     patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety~     assessments (physical examination, vital signs, electrocardiogram, clinical laboratory tests)~     performed during the subsequent 24 hours. Two weeks later, patients will return for~     additional safety assessments and will receive ProstaScint® if they don't already have a~     pre-existing ProstaScint scan. Final assessments will be performed two weeks after the~     ProstaScint® scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint®~     scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later, and~     imaging studies repeated.~   "
196391|NCT00992732|"~     The purpose of this study is to determine if treatment with HQK-1004 and valganciclovir will~     result in complete or partial responses in patients with EBV-positive lymphoid malignancies~     or lymphoproliferative disorders.~   "
196392|NCT00992719|"~     The purpose of this study is to evaluate the safety of a 2009 H1N1 influenza vaccine in~     pregnant women and to determine how their body reacts to different strengths of the vaccine.~     Two strengths of the H1N1 influenza vaccine will be tested. Since it is not known if the~     response to the vaccine in pregnant women is the same or different than in non-pregnant~     women, the study also includes a group of women who are not pregnant for comparison.~     Participants include 200 pregnant women and 100 non-pregnant women ages 18-39. Study~     procedures include physical exams, several blood samples and maintaining a memory aid to~     document daily temperature and side effects for 8 days following vaccination. Participants~     will be involved in study related procedures for about 6 months.~   "
196393|NCT00992706|"~     RATIONALE: F511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women~     receiving doxorubicin hydrochloride liposome for metastatic breast cancer.~      PURPOSE: This randomized phase III trial is studying F511 cream to see how well it works~     compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients~     receiving doxorubicin hydrochloride liposome for metastatic breast cancer.~   "
196394|NCT00992693|"~     This is a Phase 2 study of the safety and efficacy of Intravenous (IV) Ribavirin in treating~     patients presenting with a probable or suspected case of viral hemorrhagic fever (either~     Crimean Congo or Lassa Fever) at a military medical treatment hospital. All patients will be~     treated with a 10 day course of IV Ribavirin if they meet all the inclusion and none of the~     exclusion criteria.~   "
196395|NCT00992680|"~     The purpose of this study is to evaluate the safety and preliminary performance of the ROX~     Anastomotic Coupler System (ACS), with standard of care (as defined per GOLD) in patients~     with Chronic Obstructive Pulmonary Disease (COPD) as compared to standard of care alone.~   "
196396|NCT00992667|"~     The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen~     species) and NOS (reactive nitrogen species) synthesis in 10 nonsmoking mild asthmatics.~     Effects of nebulized apocynin (0.5 mg/ml, 6 ml) are assessed in exhaled breath condensate~     (EBC) after 30, 60 and 120 minutes.~   "
196398|NCT00992641|"~     SYSDIET (Systems biology in controlled dietary interventions and cohort studies) is one of~     the three centres in the NCoE Food, Nutrition and Health, 2007-2011. It consists of 12~     partners from five Nordic countries working on multidisciplinary fields of science related to~     nutritional biology. The main objective of SYSDIET is to reveal mechanisms by which Nordic~     foods and diets could be modified to promote health and prevent insulin resistance, type 2~     diabetes and cardiovascular diseases, all of which being connected to metabolic syndrome.~     Furthermore, the aim is to build up a Nordic platform for cohort studies and carefully~     conducted multi-centre dietary intervention studies, where novel nutritional systems biology~     tools can be applied besides human studies also in animal and cell culture studies. In order~     to achieve the main objective a Nordic multi-centre randomized controlled human intervention~     study is being conducted in 2009-2010 in 6-8 centres of SYSDIET consortium.~      Health of the Nordic populations has substantially improved during the last 30 years. This is~     due e.g. to marked decline in cardiovascular morbidity and mortality. However, during the~     last 10-20 years increasing obesity and sedentary lifestyle have resulted in an increase of~     metabolic syndrome and type 2 diabetes.~      Having this background, the aim of the SYSDIET consortium is to carry out a controlled,~     randomized dietary intervention study in persons with features of metabolic syndrome to find~     out the effects of a healthy Nordic food on major abnormalities in metabolic syndrome.~      Altogether 167 persons aged 30 to 65 years were recruited from 6-8 centers (40-60~     subjects/center) of the SYSDIET cohort. The main inclusion criterion is BMI 27-38 kg/m2. The~     subjects should also have at least two other IDF criteria for metabolic syndrome. Recruited~     persons will start the study by following their conventional diet for one month as a run-in~     period. After that subjects will be randomly assigned into Experimental- or~     Control-diet-group for 6 months. Experimental diet is rich in whole grain products, berries,~     fruits, vegetables and fish, and its fat intake is modified according to current Nordic~     recommendations. Control diet is based on the current information of the mean dietary intake~     and food consumption. The diets will be realized according to eating habits in each Nordic~     country.~   "
196399|NCT00992628|"~     Patients undergoing surgery or intensive care management often require a tube to be inserted~     into the trachea allowing lung ventilation. Usually a laryngoscope is used to allow~     visualisation of the larynx and facilitate intubation.~      During direct laryngoscopy, the blade of the laryngoscope is inserted into the patient's~     mouth and the structures pulled upwards out of the line of vision. If visualisation is~     difficult, users often exert excess force on the tissues to obtain an adequate view.~     Generally the applied force is evaluated by the patient's stress response such as increased~     heart rate, blood pressure or plasma cortisol levels. These changes, while important, may be~     confounded by a variety of patient factors, as well as anaesthesia. An increased force may~     also be associated with tissue trauma, dental damage, and prolonged attempts.~      The investigators' objective is to compare the force exerted on patient's tissues by the~     Macintosh laryngoscope and GlideScope video-laryngoscope. Video-laryngoscopes may be~     associated with the application of reduced force to the soft tissues of patients during~     intubation. While this is a common contention, it has not been proven. The GlideScope has a~     micro camera in the distal portion of the blade meaning a direct line of vision is not~     required. An adequate view can therefore be obtained with less displacement of tongue tissue.~     If the force exerted by the video laryngoscope is less, this would have beneficial~     implications by reducing stress response, neck movement, and trauma.~   "
196400|NCT00992615|"~     The optimal number of prostate cores extracted during a prostate biopsy performed because of~     a suspected prostate cancer is still debated. The present consensus is to sample 12 cores.~     However, recent data published in the literature brought arguments in favour of a higher~     number, probably 20. This would have the advantages of decreasing the false negatives and the~     re-biopsy rate.~   "
196401|NCT00992602|"~     This phase II trial studies how well giving liposomal cytarabine and high-dose methotrexate~     works in treating patients with breast cancer that has spread to the central nervous system.~     Drugs used in chemotherapy, such as liposomal cytarabine and methotrexate, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving liposomal cytarabine with high-dose methotrexate may kill more tumor cells.~   "
196402|NCT00992589|"~     The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an~     inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with~     placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to~     11 months of age.~   "
196403|NCT00992576|"~     The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an~     improved bowel function for constipated pain patients.~   "
196404|NCT00992563|"~     The purpose of this study is to evaluate the safety, tolerability, and effects of~     investigational drug AL-39324 for the treatment of wet AMD.~   "
196405|NCT00992550|"~     The aim of this study is to compare exposure to tobacco smoke toxins in individuals who smoke~     both cigarettes and Hookah pipes. Sixteen subjects will be hospitalized on the research ward~     for two visits of 4 days each. At one visit they will smoke their usual cigarettes in~     approximately normal frequency, and at the other visit they will smoke Hookah at least twice~     per day. The order of the visits will be randomized. On the fourth day of each visit (when~     nicotine, carbon monoxide (CO), and some carcinogen levels will be in a steady state~     condition), circadian blood and urine and expired air samples will be collected.~   "
196406|NCT00992537|"~     This trial is conducted in Europe. The aim of this clinical trial is to compare the blood~     glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250~     (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where~     the trial participant will receive one single dose of each trial product in varying order.~   "
196407|NCT00992524|"~     The purpose of this study is to compare effectiveness and safety of an oral titrated solution~     of misoprostol with vaginal misoprostol for induction of labour with an alive fetus.~   "
196408|NCT00992511|"~     The objective of this study is to evaluate the immunogenicity and safety of one or two doses~     of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two~     different processes, in adults aged 18 to 60 years.~   "
196409|NCT00992498|"~     A retrospective analysis on a cohort of unselected COPD patients admitted to pulmonary~     rehabilitation (PR) performed in one rehabilitation centre has shown that the usual program~     is feasible and effective even in the presence of complex comorbidities, although some~     combined diseases might reduce the overall proportion of patients who respond to pre-defined~     outcomes criteria (Crisafulli E, et al. Thorax 2008;63:487-92).~      The aim of this prospective study is to describe the pattern of prevalence of the most~     frequently associated COPD-comorbidities and the clinical impact on rehabilitation outcomes,~     referred to 3 teaching and 1 private hospitals admitting for pulmonary rehabilitation~     purposes.~   "
196410|NCT00992485|"~     Up to date, a sure cure for Crohn's fistula has not known and the fistula recurrence rate is~     high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co.~     Ltd., for human adipose-derived stem cell. In this study, patients are given injection of~     ADIPOPLUS in fistula site and followed for 8 weeks to test the safety and efficacy.~   "
196413|NCT00992446|"~     This phase II trial studies the side effects and how well bortezomib and vorinostat work in~     treating patients with non-Hodgkin lymphoma (NHL) after patients' own stem cell (autologous)~     transplant. Bortezomib and vorinostat in the laboratory may stop the growth of lymphoma cells~     and make them more likely to die by blocking some of the enzymes needed for cell growth.~     Giving bortezomib together with vorinostat after an autologous stem cell transplant may thus~     kill lymphoma cells that remain after transplant.~   "
196414|NCT00992433|"~     The purpose of this study is to see how the body reacts to different strengths of the H1N1~     flu shot in persons infected with human immunodeficiency virus (HIV). This study will also~     compare how the CD4 count (cells that help fight disease) affects the body's response to the~     H1N1 flu shot. In this study, 2 strengths of the H1N1 flu shot will be given twice, about 3~     weeks apart. The results of this study will help researchers find out if the different~     strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at~     fighting H1N1 flu. About 240 HIV positive subjects, ages 18-64 years, will be asked to take~     part in this study. Study procedures include: blood sampling, physical exams, and use of~     memory aids to record temperature, medications and symptoms. The length of patient~     participation is about 7 months.~   "
196415|NCT00992420|"~     This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The~     purpose of this study is to assess which genes influence residual platelet reactivity on~     standard dose clopidogrel therapy, and also to determine whether certain genes influence the~     incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in~     patients who have high residual platelet reactivity on standard dosing.~   "
196416|NCT00992407|"~     The purpose of this study is to evaluate the efficacy and safety of long acting injectable~     (LAI) risperidone and oral risperidone treatment on participants with schizophrenia~     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often~     with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder~     (a mixed psychiatric disorder relating to a complex psychotic state that has features of both~     schizophrenia and a mood disorder such as bipolar disorder).~   "
196417|NCT00992394|"~     This study proposes to compare 2 different methods for managing a subject with psoriasis who~     has achieved good disease control, as defined by a clinical response with a Physician Global~     Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.~      The first method involves stopping etanercept treatment on entry into the study, with the~     option to reinitiate etanercept at 50 mg once weekly after medical review and agreement~     between the subject and the investigator. The second method involves continuing on etanercept~     at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical~     review and agreement between the subject and the investigator. Subjects will be randomized~     into one of these two study arms.~   "
196418|NCT00992381|"~     The purpose of this study is to determine whether the absorption of naproxen from the PN 400~     combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets~     (Naprosyn®), which are currently sold in Australia.~   "
196419|NCT00992368|"~     Several works show breast hypertrophy as pain cause, postural alterations, dermatitis and~     decrease of the functional capacity and of the self-esteem. The economical evaluations are~     destined to esteem the costs in alternative ways of attendance to the health, comparing, for~     instance, clinical strategies with surgical strategies.~      OBJECTIVE: To analyze cost-effectiveness in reduction mammaplasty.~   "
196420|NCT00992355|"~     This randomized controlled trial compares two regimens of topical therapy:~        -  tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day~        -  combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four~          times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three~          times/day. The topical treatment is administered for 28 days after phacoemulsification.~      Patients are independently assessed by two ophthalmologists. On day 28, patients are~     evaluated for~        -  corneal edema~        -  conjunctival redness~        -  anterior chamber reaction. Moreover, the cases necessitating continuation of treatment~          are compared in the two groups on day 28 and 42.~   "
196421|NCT00992342|"~     The purpose of this study is to investigate safety and toleration of multiple oral doses as~     well as the time course of PF-03893787 concentration in the blood following dosing by oral~     solution.~   "
196422|NCT00992329|"~     The purpose of this research is to see if certain tablet formulation factors affect oral drug~     absorption. Medications taken by mouth, such as tablets, need to be absorbed into the body in~     order to do any good. Tablets contain a drug, but also contain non-drug ingredients that are~     called excipients or fillers. Excipients in the tablet, and the way in which the tablet is~     manufactured, both can impact how much drug is absorbed into the body. That is, tablet~     formulation factors can cause a tablet to be effective or not effective.~      Tablets in this research contain the drug ciprofloxacin hydrochloride. Ciprofloxacin is an~     antibiotic to treat infections, such as lung infections. This drug is being used since it has~     low water solubility and is probably sensitive to tablet formulation factors.~   "
196423|NCT00992316|"~     The purpose of the study is to investigate the safety, toleration and pharmacokinetics of~     single oral doses of PF-04531083 in healthy male subjects.~   "
196424|NCT00992303|"~     RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the~     laboratory may help the study of cancer in the future.~      PURPOSE: This research study is collecting tissue samples from patients with cancer~     undergoing radiation therapy.~   "
196425|NCT00992290|"~     This research proposes to find whether the probiotic lactobacillus GG is safe and well~     tolerated in patients with minimal hepatic encephalopathy. We also want to get insight into~     the mechanisms of action of LGG.~   "
196426|NCT00992277|"~     This study will:~      Evaluate the in vivo histological and molecular effects of treatment with eMatrixCO2 and to~     determine the dynamics of their development over time following treatment.~      Determine the safety and efficacy of treatment with eMatrixCO2 for use in Aesthetic~     dermatological procedures requiring the ablation, vaporization, excision, incision, or~     coagulation of soft tissue.~   "
196467|NCT00991744|"~     -  Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with~          intrathecal liposomal cytarabine and prednisolone during maintenance therapy will~          decrease the CNS relapse rate in high-risk ALL patients.~        -  Both acute and long-term toxicity are equal in both treatment arms.~   "
196427|NCT00992264|"~     The current study tested the effectiveness of four potentially important tailoring factors~     (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the~     context of an online motivational intervention for smoking cessation. A fifth factor was~     originally planned by dropped during intervention development due to confounds with the other~     planned factors. Information learned from this study will inform how to best design an online~     interventions for smoking cessation. Participants were recruited from a large, regional U.S.~     health plan. Using a full factorial design to screen for important main effects and 2-way~     interactions, participants were randomized to receive one of 16 different experimental factor~     combinations and followed for one year to assess program impact on smokers' use of~     empirically-validated cessation treatment and abstinence.~   "
196428|NCT00992251|"~     The objective of this registry is to collect data on patient demographics, medical history,~     change in prostate, bone and overall health of the patients receiving androgen ablation~     treatment using Eligard. Data collected through this national registry program provides an~     opportunity to increase knowledge of efficacy and safety of the long term treatment with~     Eligard, provide a platform to better identify patient segments for the therapy with~     Eligard®. Furthermore registries are the only tools to accurately capture rare adverse~     events.~   "
196429|NCT00992238|"~     The purpose of this study is to compare the relative bioavailability of Flavoxate~     Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas®~     tablets 100mg by SmithKline Beecham Pharmaceuticals under fasting conditions.~   "
196430|NCT00992225|"~     The primary purpose of this study is to determine the objective response rate (complete and~     partial response) for patients who receive LY573636 for metastatic breast cancer.~   "
196431|NCT00992212|"~     This present study, a phase II, open label study will evaluate the immunogenicity,~     tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent~     Subunit Influenza Virus Vaccine in healthy subjects aged 18 years and above. This study will~     explore the effect of the previous and concomitant exposure to a seasonal influenza~     vaccination to the immunogenicity and safety profile of two different doses of an adjuvanted~     H1N1sw vaccine.~   "
196432|NCT00992199|"~     Gastric cancer is the leading cause of death from a intestinal tract cancer in China.In most~     cases, the high death rate is due to tumor that has spread beyond the gastric cancer at the~     time of diagnosis. In China, the standard chemotherapy for the initial treatment of gastric~     cancer is a combination of a platinum analogue with 5-Fu.With modern surgical interventions~     and contemporary chemotherapy, most patients attain better clinical remission.The majority of~     them, however, will eventually have a relapse and die of the disease.~      The peritoneal cavity is the principal site of disease in gastric cancer.Although the~     intensity of intravenous chemotherapy is limited mainly by myelotoxicity, several active~     drugs can be administered directly into the peritoneal cavity. The rationale for~     intraperitoneal therapy in gastric cancer is that the peritoneum, the predominant site of~     tumor, receives sustained exposure to high concentrations of antitumor agents while normal~     tissues, such as the bone marrow, are relatively spared.~      The investigators conducted this trial to investigate the efficacy and safety of~     intraperitoneal chemotherapy in advanced gastric cancer.~   "
196433|NCT00992186|"~     The purpose of this study is to determine the safety and effectiveness of the study drug~     carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the~     gland that makes fluid that aids movement of sperm).~   "
196434|NCT00992173|"~     This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I~     131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that~     has already been used in many children to treat neuroblastoma, and it is known to shrink some~     of the tumors, and cause manageable side effects. When administered intravenously, Iobenguane~     I 131 accumulates in the neuroblastoma cancer cells and causes them to die.~      In this study the investigators are investigating the use of a new form of Iobenguane I 131~     called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of~     radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to~     determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk~     neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when~     given to patients with high-risk neuroblastoma.~   "
196435|NCT00992160|"~     This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant~     15mg/day for treatment of Primary Insomnia in adults outpatients.~   "
196436|NCT00992147|"~     Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques~     including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells,~     and differentiation into pure and immature adipocytes. This was an open-label,~     dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed~     for 12 weeks according to the clinical trial protocol.~   "
196437|NCT00992134|"~     The objective of the study is to demonstrate the safety, tolerability, and activity of~     Rituximab-Bendamustine-Cytarabine(R-BAC) regimen in patients with mantle cell lymphoma (MCL)~     aged 65 years or more, as well as in younger patients who are not eligible for intensive~     regimens including/not including autologous transplantation.~   "
196438|NCT00992121|"~     This study will determine whether blood tests, tumour imaging and tumour tissue analysis can~     reveal effects of drugs that block blood vessel growth (angiogenesis) in patients with renal~     cancer.~   "
196451|NCT00991952|"~     This randomized phase II trial studies how well giving irinotecan hydrochloride with or~     without alvocidib works in treating patients with advanced stomach or gastroesophageal~     junction cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as~     irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Alvocidib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     irinotecan hydrochloride is more effective with or without alvocidib.~   "
196452|NCT00991939|"~     This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment~     with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP).~     The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a~     more durable remission than patients treated with prednisone.~   "
196439|NCT00992108|"~     Botulinum toxin-A (BTX-A) prevents the release of acetylcholine in presynaptic terminals of~     the neuromuscular junction. It has been proposed to be effective in spastic conditions of the~     head and neck including oromandibular dystonias, bruxism, and muscular hypertrophy (1,2,3,4).~     However, only one randomized, double-blinded, placebo controlled trial has been completed~     involving 20 patients demonstrating both objective and subjective improvement in the BTX-A~     treated group over those treated with saline at one week, one month, and six months (5).~      Currently, in most orofacial pain practices, when the diagnosis of masticatory myofascial~     pain in the head region is made, patients are treated with a standard myofascial protocol.~     This protocol involves stretching, application of moist heat, spray and stretch, and~     lidocaine trigger point injections into the masticatory muscles. This is considered the~     standard of care among most orofacial pain practioners.~      There have been no randomized, double-blinded, head-to-head trials comparing BTX-A injections~     to lidocaine injections in the treatment of masticatory myofacial pain. Moreover, in all~     studies, muscles were targeted using surface landmarks with no confirmatory tests to~     guarantee the medication was administered to the intended muscle. In previous studies, the~     medial and lateral pterygoid muscles, important masticatory muscles that is often hyperactive~     in masticatory myofacial pain was not injected due to lack of palpable surface landmarks.~     Ultrasound and electromyography (EMG) guidance will help us locate these muscles.~      The purpose of this study is to objectively measure functional improvement in patients with~     masticatory myofascial pain injected with lidocaine versus BTX-A. A pilot study enrolling 20~     patients is proposed. 20 patients will be randomized to receive either BTX-A or lidocaine~     injections into the bilateral temporalis, masseter, and medial and lateral pterygoid.~     Objective and subjective clinical parameters will be measured. These include pain at rest and~     with chewing, maximum non-assisted and assisted mouth opening, protrusive and laterotrusive~     jaw movements, subjective efficacy of treatment, and side-effects of treatment. Patients will~     be assessed at baseline, one week, one month, and three months after the procedure.~   "
196440|NCT00992095|"~     The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet~     under fasted conditions.~   "
196441|NCT00992082|"~     The purpose of this study is to determine whether local infiltration analgesia is more~     effective than intrathecal morphine in reducing postoperative pain in total knee~     arthroplasty.~   "
196442|NCT00992069|"~     Common treatments for tuberculosis (TB) can interfere with certain antiretroviral (ARV)~     medications used to treat HIV. People whose immune systems are weakened by HIV infection are~     susceptible to TB, so it is important to find treatments for both that can be given in~     combination. This study will test the safety of combining a new medication for TB with an~     already approved HIV medication in healthy adults.~   "
196443|NCT00992056|"~     Research objectives~      The objective of this randomized, placebo-controlled, 2 period crossover clinical trial is to~     determine the effects of nebivolol versus metoprolol on ambulatory blood pressure, the blood~     pressure response to dietary sodium loading, and renal handling of an acute sodium load in~     postmenopausal women with hypertension.~      Hypothesis~      Nebivolol will result in a blunted response of blood pressure to oral sodium administration~     and improved renal handling of an intravenous sodium load in comparison with metoprolol in~     hypertensive postmenopausal women.~      Research plan~      Study design~      The study consisted of a randomized crossover trial of the effects on sodium sensitivity and~     renal sodium handling of nebivolol versus metoprolol. All study procedures were carried out~     under the direct supervision of the Principal Investigator in the outpatient and inpatient~     research unit of the University of Miami Division of Clinical Pharmacology.~      Primary endpoint~      Change in 24-hour mean systolic blood pressure determined by 24-hour ambulatory blood~     pressure monitor (ABPM) from the final day of low sodium to the final day of high sodium in~     nebivolol versus metoprolol~   "
196444|NCT00992043|"~     Creatine supplementation is capable of improving glucose tolerance in healthy subjects. The~     researchers aim to investigate whether this supplement can affect metabolic control in~     diabetic patients.~   "
196445|NCT00992030|"~     Combined modality therapy has then emerged as the standard of care for limited-stage~     Hodgkin's lymphoma and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)~     chemotherapy that is devoid of alkylating agents and associated with a low potential for~     gonadal toxicity and leukemogenesis, is currently considered a gold standard. Nevertheless,~     the disadvantage to combine radiotherapy to ABVD is represented by late cardiovascular events~     (myocardial dysfunction and coronary or valvular disease), especially when the heart is~     within the radiation field; bleomycin pulmonary toxicity also is increased in conjunction~     with RT and secondary tumors, in particular in the RT fields. This study aims at treating~     patients with limited disease with multiagent chemotherapy alone, without irradiation, and~     using radiotherapy only for relapses.~   "
196446|NCT00992017|"~     Both pregnant women and people infected with HIV are at increased risk of viral infection,~     including influenza infection. Pregnant women infected with HIV may be at particular risk of~     infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity~     of an H1N1 influenza vaccine in pregnant women infected with HIV.~   "
196447|NCT00992004|"~     The purpose of this study is to determine the efficacy and the tolerance on 15 days of a~     turmeric extract (Arantal®) on pain related to gonarthrosis.~   "
196448|NCT00991991|"~     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer~     may help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at tumor tissue samples from patients with stage I,~     stage II, or stage III malignant melanoma.~   "
196449|NCT00991978|"~     Breast cancer is the most common cause of cancer death among women. Yearly around 12,500~     Dutch women are diagnosed with breast cancer and 3,500 die of this disease. One of the~     problems leading to such striking effect refers to late tumor detection due to inadequate~     sensitivity of current imaging techniques. Current screening is performed by means of~     mammography, consisting of traditional film-screen mammograms of digital mammograms. These~     digital mammograms offer digital enhancement to aid interpretation, which is especially~     helpful in women with dense breast tissue. Screening mammography is nowadays the single most~     effective method of early breast cancer detection. For screening of high risk individuals,~     increasingly the magnetic resonance imaging (MRI) technique is emerging. However, none of the~     above mentioned techniques has an optimal sensitivity and specificity, leading for instance~     to a significant portion of false positive results. The clinical consequence of this error is~     that additional tests and procedures are performed in women who may not have cancer. In the~     United States, for example, 11% mammograms require additional evaluation; the lesion turns~     out to be benign in more than 90% of cases [1].~      False-positive readings False positive readings are more common in younger women, both~     because the tests are less specific and because breast cancer is less common [2,3]. As a~     result, more follow-up procedures, including invasive procedures such as biopsies, will be~     done in younger women even though fewer cancers will be found. Furthermore, because breast~     cancer screening occurs repeatedly, the risk of a false-positive study is likely to rise with~     repeated screening [4].~      Emerging adjuncts to mammography include ultrasonography, which is helpful for further~     assessment of known areas of interest, and magnetic resonance imaging. Image-guided biopsy -~     directed by ultrasonography or stereotactic mammography views - plays a critical role in~     histological confirmation of suspected breast cancer.~   "
196450|NCT00991965|"~     The purpose of this research study is to shorten the treatment time course for patients who~     are scheduled for surgery to have a dental implant(s) placed into the upper front part of~     their mouths and need to have more bone in their jaws to support the implant.~   "
196464|NCT00991783|"~     The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and~     the safety of digoxin.~   "
196453|NCT00991926|"~     The beneficial effects on plasma lipids of Orlistat, a selective gastrointestinal lipase~     inhibitor, are largely independent of weight loss, and might include differential effects~     plasma non-esterified fatty acid (NEFA). Apart from their well-known effects on insulin~     resistance pathogenesis, elevated NEFA levels probably play also the most important role at~     peripheral levels in the pathogenesis of Growth Hormone (GH) insufficiency in obesity. Aim of~     this observational, mono-centre, randomized, simple-blind, cross-over study is to verify if~     the short-term treatment with Orlistat may results in decline in NEFA circulating levels when~     used in conjunction with low-fat diet and if this effect may restore the endogenous activity~     of GH/ Insulin-like growth factor (IGF)-1 axis, in the context of GH regulation of~     lipoprotein metabolism, thus adding a further benefit of Orlistat in obesity cross-linked~     neuroendocrine and metabolic dearrangement.~   "
196454|NCT00991913|"~     Despite recent advances in postoperative delirium research, the proportion of patients with~     postoperative delirium is still high ranging between 20-80%. Although postoperative delirium~     is a frequent complication and is associated with the need for more inpatient hospital care~     and longer length of hospital stay, little is known about risk factors for recovery room~     delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine~     pre- and intraoperative risk factors for the development of RRD among patients undergoing non~     cardiovascular surgery.~   "
196455|NCT00991900|"~     Adequate perfusion and oxygenation is essential for the function of the inner retina.~     Although this is a well known fact, measurement of oxygen saturation in the eye is still a~     delicate and not fully explored task. However, recently a new instrument for the non-invasive~     measurement of retinal vessel oxygen saturation has been introduced. Unfortunately, no data~     about reproducibility in humans is yet available for this instrument. Consequently, the~     current study seeks to evaluate the short term and day to day reproducibility of retinal~     vessel oxygenation in healthy volunteers.~      20 healthy volunteers will be included and oxygen saturation of retinal vessels will be~     determined. The reproducibility of the results will be tested by repeated measurements and~     the collected data will be independently analyzed by two observers.~   "
196456|NCT00991887|"~     The investigators hypothesized that radiation therapy could be safely administered acutely~     after elbow trauma, and it would decrease the number of patients that would require surgical~     excision of heterotopic ossification.~   "
196457|NCT00991874|"~     Five percent of children in the UK are prescribed steroid inhalers to control asthma symptoms~     but there is no test to determine whether the dose of steroids is correct. Too much steroid~     treatment has potential side effects and too little may lead to asthma attacks. Exhaled~     nitric oxide (ENO) is a gas present in everyone's breath and may be a useful meter for~     asthma control. In children, ENO can be measured easily and quickly, the results are~     available immediately to the doctor or nurse and for these reasons ENO is an attractive~     clinical test.~      Pioneering studies have used ENO to help clinicians treat asthmatic adults and children and~     the results are promising. Breathing tests improved among those where asthma treatment was~     guided by ENO and asthma symptoms were slightly less frequent. These studies all used a~     single ENO value to increase or reduce treatment and study authors have suggested there~     should be a range of ENO values where treatment is neither increased nor reduced; what is not~     known is what these ENO values may be. Elevated NO is associated with a number of factors~     other than asthma, including allergy and pollen exposure. What is not known is how factors~     other than asthma affect ENO measurements over time.~      The proposed study will answer two important questions: What values of ENO indicate that~     steroid treatment should be increased or reduced? And how much does ENO rise and fall~     normally? The investigators will recruit 200 asthmatic and non-asthmatic children. The~     investigators will measure ENO on six occasions over a 12-month period. The investigators~     will measure factors that may affect ENO other than asthma. For the asthmatic children, the~     investigators will also assess asthma control. The investigators' methodology is based on~     several years experience with ENO. The investigators' results will allow ENO to be used to~     monitor asthma.~   "
196458|NCT00991861|"~     The aim of this study is to determine the efficacy, safety and tolerability of either a once~     or twice daily topical application of LAS41007 compared to a twice daily application of~     LAS106521 in the treatment of actinic keratosis.~   "
196459|NCT00991848|"~     Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous~     manifestations. The objective of this study was to evaluate the effect of the combination of~     intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A~     prospective, randomized, double-blind, comparative study was conducted. All patient received~     25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients~     of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks.~     Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on~     a verbal numerical scale.~   "
196460|NCT00991835|"~     Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute~     coronary syndrome. Thus, identification of plaques vulnerable to rupture has become~     important. The natural history of individual plaques is unknown and needs to be established.~     Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality~     for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively~     investigate the relationship between the characterization of coronary plaques and~     cardiovascular events in a large multicenter study.~   "
196461|NCT00991822|"~     Glaucoma is one of the most common causes of blindness in the industrialized nations. For a~     long time glaucoma has been defined as a disease in which high intraocular pressure (IOP)~     leads to irreversible optic disk damage and concommitant visual field loss. However, recent~     investigations show that IOP is not necessarily an adequate measure of clinical severity or a~     predictor of clinical progression: about 20% of all eyes with high IOP do not develop visual~     field loss and some patients suffering from visual field loss due to optic disk damage have~     normal IOP. Hence, factors other than IOP are likely involved in the pathogenesis of~     glaucoma. The role of vascular factors in the pathogenesis of glaucoma has recently received~     much attention and optic nerve head hypoperfusion may play a critical role in the development~     of glaucoma. It may therefore be important for an optimal prevention of visual field defects~     in glaucoma that the topical antiglaucoma drugs used do not only reduce IOP but also~     stabilize or enhance the perfusion of the optic nerve head.~      Therefore, the aim of the present study is to compare the effect of a 3 months treatment with~     timolol or dorzolamide in patients with open angle glaucoma on optic disk blood flow.~   "
196462|NCT00991809|"~     The purpose of this study was to follow a person's response to experimental pain after~     multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can~     tolerate the pain more, less, or the same at the end of the study.~   "
196463|NCT00991796|"~     The purpose of this study is to determine the effect on toxicity of the addition of CS 1008~     to a platinum based chemotherapy regimen on the progression-free survival (PFS) in subjects~     with stage IIIB wet or stage IV NSCLC.~   "
196468|NCT00991731|"~     The purpose of this research study is to evaluate three different approaches for increasing~     physical activity in African American women who are not currently doing enough physical~     activity. One approach will teach people about physical activity, in groups, using general~     principles (general physical activity program). The second approach will teach people about~     physical activity, in groups, using principles from the bible (faith-based physical activity~     program). The third approach will teach people about physical activity by giving them written~     materials created at the National Institutes of Health (control group). Control groups are~     used in research studies to see if the program being studied really does have an effect on~     physical activity. At the end of the study, people in the control group will also participate~     in either the general physical activity program or the faith-based physical activity program.~   "
196469|NCT00991718|"~     This is an open-label, Phase I, single-center, single-dose administration study to determine~     the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and~     to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). Parts A~     and B will be conducted sequentially, with ≥ 7 days between dosing the sixth subject in Part~     A and dosing the first subject in Part B. In each part, 6 healthy female subjects of~     non-childbearing potential, between 18 and 65 years of age (inclusive), will be dosed.~   "
196470|NCT00991705|"~     The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics~     of fimasartan.~   "
196471|NCT00991692|"~     A multisite trial to testing different dosage levels of a systematic form of Pediatric~     Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6~     hours of daily therapy services for 21 days. This was compared to a moderate dosage level of~     3 hours of daily therapy services for 21 days. It was hypothesized that children receiving~     the higher therapy dosage would have greater and more clinically significant benefits from~     ACQUIREc Therapy but that both groups of children would benefit from the therapy services.~   "
196472|NCT00991679|"~     The aim of this study is to investigate the expression of CXCL9, CXCL10, CXCL11, and CXCR3 in~     the tear film and ocular surface of patients with dry eye syndrome.~      Thirty-three patients with dry eye (16 Sjögren's syndrome and 17 non-Sjögren's syndrome~     patients) and 15 control subjects were recruited. The concentrations of CXCL9, CXCL10, and~     CXCL11 in tears were measured using enzyme-linked immunosorbent assay. The correlation~     between chemokine levels and tear film and ocular surface parameters was analyzed. Expression~     of CXCL9, CXCL10, CXCL11, and CXCR3 in the conjunctiva was evaluated using~     immunohistochemistry. Flow cytometry was performed to count CXCR3+ cells and CXCR3+CD4+ cells~     in the conjunctiva.~   "
196473|NCT00991666|"~     Several methods have been proposed for the measurement of pulsatile ocular blood flow (POBF).~     The pneumatic tonometer, which is commercially available, assesses POBF by measurement of~     intraocular pressure (IOP) changes during the cardiac cycle. The investigators have recently~     developed a method for the measurement of ocular fundus pulsation, which is based on laser~     interferometry. In contrast to the Langham system the method is non-contractile and yields a~     high topographic resolution. Moreover, the pneumatic tonometer assesses the ocular pressure~     pulse, whereas ocular fundus pulsation is a point measure of the ocular volume pulse. These~     two parameters are related by the ocular rigidity, which refers to the mechanical properties~     of the eye coats.~      Age-related macular degeneration (AMD) is the most common cause of blindness in the~     industrialized nations. The mechanisms behind this severe eye disease are, however, still~     obscure. It has been hypothesized that alterations in choroidal blood flow and ocular~     rigidity may contribute to the development and progression of AMD. However, there is~     currently little data to confirm this hypothesis. The present study is an attempt to~     investigate choroidal blood flow and ocular rigidity by employing laser interferometric~     measurement of fundus pulsation and pneumotonometric measurement of fundus pulsation.~   "
196474|NCT00991653|"~     This study aims to identify and quantify the factors associated with excess weight gain~     following treatment for breast cancer. It is believed that breast cancer patients gain more~     than 4% of their weight at diagnosis which is likely accompanied by an increase in body fat~     and waist circumference. It is further thought that this excess weight and increase in body~     fat and waist circumference are associated to tumour characteristics, chemotherapy, menopause~     status at diagnosis and the presence of genes related to obesity. It is also thought that~     women treated with chemotherapy have higher levels of glucose and insulin.~   "
196475|NCT00991640|"~     The investigators developed a program aimed at enhancing primary care physician (PCP) teams'~     expertise, self-efficacy and attitudes with respect to obesity management. The investigators~     implemented and evaluated this obesity management system based on a preceptorship combined~     with a virtual learning community favouring continuous support of family medicine groups~     (FMGs, Groupes de Médecine Familiale) by a team of experts in obesity management; significant~     improvements regarding their attitudes and perception of self-efficacy were observed~     immediately after the preceptorship and maintained after one year. Furthermore, the~     investigators observed significant changes in their practice that were maintained one year~     later.~      The investigators hypothesize that their program combining preceptorships with a virtual~     community will improve: (1) management and weight loss of obese/overweight subjects who are~     treated by PCPs for hypertension (HTN), type 2 diabetes (DM2) or impaired glucose tolerance~     (IGT); and (2) screening and initial management of obesity among unselected patients of PCPs~     who practice in FMGs.~   "
196476|NCT00991627|"~     The aim of this study is to compare two different therapeutic approaches to blood pressure~     reduction: pharmacological vs. non-pharmacological. The setting is that of patients~     undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval~     compression syndrome, which causes a sudden drop in blood pressure.~   "
196477|NCT00991614|"~     The objective of this investigation is to compile clinical experience on the use of the~     Evolution® Duodenal Stent (Cook Ireland), a CE marked device intended for the palliative~     treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by~     malignant neoplasms. It is not the goal to change the usual treatment practice of the~     investigator or the center, nor to collect information on uses outside the product's~     indications. Patients will be treated as per usual medical practices.~   "
196478|NCT00991601|"~     Patients with tumors in liver or pancreas are randomized to ultrasound (UL)-guided FNAC~     biopsies with guidance method or UL-guided FNAC biopsies with free-hand method.~   "
196479|NCT00991588|"~     The purpose of this investigation is to determine the clinical outcome of surgical~     reconstruction of complete ruptures to the posterior cruciate ligament (PCL) and~     posterolateral structures of the knee joint. The outcome will be determined with validated~     and rigorous knee rating systems between 2 and 10 years postoperatively. The results will be~     determined by the analysis of subjective and functional factors, sports and occupational~     activity levels, a comprehensive physical examination, and a radiographic evaluation. We~     hypothesize that the appropriately indicated procedures will effectively restore normal knee~     stability and function in patients with isolated or combined injuries to these structures.~   "
196480|NCT00991575|"~     The main purpose of this study is to investigate progression of late complications of~     diabetes during the last ten years in a well characterized cohort of type 1 diabetes with a~     long duration of the disease, and to define factors responsible for the progression of late~     complications.~   "
196481|NCT00991562|"~     The purpose of this study is to test IMGN901 in combination with lenalidomide and~     dexamethasone every 28 days.~   "
196482|NCT00991549|"~     This study compared the efficacy at one year of an interdisciplinary approach including~     individual counseling and group seminars versus group seminars alone to induce weight loss in~     subjects at high risk of developing type 2 diabetes.~      This study also compare if a participant's presence in small informative meeting groups as~     the only form of intervention is sufficient to induce a lifestyle change, thus inducing the~     weight loss needed for the prevention of the diseases associated with obesity.~   "
196483|NCT00991536|"~     Quality of sleep is profoundly affected in patients with hypercapnic respiratory failure and~     restrictive disorders, with a decrease in rapid eye movement (REM) and slow wave sleep, and~     an increase in sleep fragmentation. Assisted ventilation aims at improving blood gases, but~     may also have a favorable impact on sleep structure. The investigators reviewed~     polysomnographic and blood gas data obtained between 1987 and 2008 in 95 patients with~     restrictive pulmonary disorders, before and after implementing non-invasive ventilatory~     support.~   "
196484|NCT00991523|"~     The purpose of this study is to examine the effects of post-exercise protein ingestion prior~     to sleep on overnight protein kinetics and muscle recovery.~   "
196485|NCT00991510|"~     The purpose of the study is to further investigate how much of the drug substance~     mycophenolate mofetil can be found in the blood of patients with kidney or renal~     transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side~     effects of the two products will be compared. All information already available on these~     products indicates that the safety profiles of the two products will be the same.~   "
196486|NCT00991497|"~     The purpose of this study is to compare the results of foam treatment of varicose veins (foam~     sclerotherapy) in patients who wear compression bandages for 24 hours or 5 days after~     treatment.~   "
196487|NCT00991484|"~     Analysis of collagen subtype subcutaneously and genetic analysis of patients from families~     with a tendency to hernias. Furthermore circulating biomarkers and biomarkers extracted from~     the subcutaneously tissue such as MMP's (matrix metallo proteinases) and TIMP's (tissue~     inhibitor of metallo proteinases) will be measured.~   "
196488|NCT00991471|"~     The primary objective of this study is to investigate whether the introduction of a~     physician-nurse supplementary triage assessment team (MDRN STAT) is effective in improving~     time-based performance indicators for wait times. Secondary objectives will examine the~     quality of patient care and health care worker satisfaction and the cost-effectiveness of the~     program~   "
196489|NCT00991458|"~     This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops~     administered twice daily before and following LASIK surgery.~   "
196490|NCT00991445|"~     The purpose of this study is to determine whether Minimal Invasive Surgery results in less~     postoperative pain and better mobilization than conventional technique in Unicompartmental~     Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.~   "
196491|NCT00991432|"~     The purpose of this research study is to determine whether this study treatment can improve~     the bone structure of the upper front part of the jaw in patients who are scheduled for~     surgery to have a dental implant(s) placed into the upper front part of their mouths and need~     to have more bone in their jaws to support the implant, so that a dental implant can later be~     inserted.~   "
196492|NCT00991419|"~     The purpose of this study is to compare PET measurements of fibrillar amyloid burden using~     [18F]AZD4694.~   "
196493|NCT00991406|"~     The purpose of this research is to find the optimal patterns of functional electrical~     stimulation (FES) of muscles in the lower legs that will improve walking ability in those who~     have had a stroke and at the same time ensure walking stability. FES involves applying small~     electric currents to the nerves, which cause the muscles to contract.~      FES research projects vary from simple investigations of the therapeutic effects of exercise~     on muscle function and skin health, to more complex studies of functional movements such as~     standing or walking.~   "
196494|NCT00991393|"~     The purpose of this research study is to shorten the treatment time course for patients who~     are scheduled for surgery to have a sinus lift and dental implant(s) placed into the upper~     front part of their mouth, and need to have more bone in their jaws and a thicker sinus floor~     to support the implant.~   "
196495|NCT00991380|"~     The investigators aim to establish the effectiveness of a prescribed, community-based~     lifestyle modification program for those with recently diagnosed diabetes. The investigators~     hypothesize that those who enter a 6 month program will report greater levels of physical~     activity compared to a group who do not enter the program but who continue to receive usual~     care.~   "
196496|NCT00991367|"~     The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort)~     usage in the treatment of recent post-surgical scars. The duration of this double-blind~     placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to~     be recruited and randomized for the study is 90.~   "
196497|NCT00991354|"~     An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study~     is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or~     without an IL-12 adjuvant when given using electroporation.~   "
196588|NCT00990145|"~     This was a Phase I, single-center, randomized, double-blind, placebo-controlled, ascending~     multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of orally~     administered EDP-322 in healthy adult volunteers.~   "
196498|NCT00991341|"~     The RECESS study will compare the effects of transfusing red blood cell units stored <= 10~     days vs. red blood cell units stored >= 21 days, in patients who are undergoing complex~     cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis~     is that there is a clinically important difference between the effects of shorter-storage red~     cell units and longer-storage red cell units on clinical outcomes and mortality risk.~   "
196499|NCT00991328|"~     The purpose of this study is to determine whether brain oxygenation measured by cerebral~     oximeter has an impact on neurocognitive dysfunction.~   "
196500|NCT00991315|"~     The primary objective of this study is to collect material for study's to assess mechanisms~     of tumor progression, mechanisms of resistance, isolation of stem cells and biologic markers~     in tissue, serum and peripheral blood mononuclear cells.~   "
196501|NCT00991302|"~     Adherence to highly active antiretroviral therapy (HAART) is critical to successful treatment~     of HIV. This study tested an intervention that helps people infected with HIV take all their~     medications when and how they were supposed to.~   "
196502|NCT00991289|"~     Infection with hepatitis C virus (HCV) can cause liver scarring, or cirrhosis, and this~     usually occurs more rapidly among people infected with both HCV and human immunodeficiency~     virus (HIV). People infected with both HCV and HIV have poor response to the current HCV~     treatments. This phase II pilot study evaluated whether adding a new HCV medication improves~     response to the current standard HCV treatment with pegylated interferon and ribavirin in~     people with both HCV and HIV.~   "
196503|NCT00991276|"~     The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole~     versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.~   "
196504|NCT00991263|"~     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer~     may help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at tissue samples from women treated with paclitaxel~     for breast cancer on clinical trial CALGB 9344 or CALGB 9741.~   "
196505|NCT00991250|"~     The purpose of this study is to elucidate whether SentoClone® gives improved treatment~     responses in patients with advanced malignant melanoma in comparison to established reference~     treatment(s).~   "
196506|NCT00991237|"~     The purpose of the study is to evaluate the effect of PRF treatment adjacent to the lumbar~     dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic lumbosacral radicular~     syndrome (LRS).~      Prospective, single blinded, multicenter clinical trial.~   "
196507|NCT00991224|"~     This research study is being carried out to study a new way to possibly treat HIV. T‐cells~     are one of the white blood cells used by the body to fight HIV. CD8 T‐cells are a type of~     T‐cell used by the body to detect and kill cells which have been infected by foreign viruses~     or organisms, including the HIV virus. CD8 T‐cells must identify the HIV virus in order to~     kill it. Because HIV is constantly changing the way it looks to the CD8 T‐cells, some of the~     HIV virus escapes detection and is not killed by the CD8 T‐cells.~      This research study uses a T cell receptor (TCR) protein specific for HIV (SL9 TCR) and adds~     it to the CD8 T‐cells in the laboratory in order to help the CD8 T‐cells recognize the~     constantly changing HIV virus and make it able to fight HIV more efficiently. TCR stands for~     T cell receptor. TCRs are found on the surface of T cells and allow the T cells to recognize~     other cells. Laboratory studies have shown that when CD8 T‐cells are modified with SL9 TCRs,~     they kill cells that are infected with HIV better than normal CD8 T‐cells can. On the basis~     of these laboratory results, there is the potential that SL9 TCRs may work in people infected~     with HIV and improve their immune system by killing HIV infected cells and thus may help~     control HIV infection.~      Two different SL9 TCRs will be tested in this study, WT‐gag‐TCR and α/6‐gag‐TCR. Two~     different types of SL9 TCRs are being used in this research study because the laboratory~     studies suggest that the different SL9 TCRs will function differently depending on the amount~     of virus in your body. A goal of this clinical study is to test the effects of infusions of~     either SL9 TCR in the presence or absence of a viral load.~      All subjects who receive WT‐gag‐TCR or the α/6‐gag‐TCR T cells will be enrolled in a Long~     Term Follow up study to monitor subjects. Subjects will be followed every 6 months for five~     years following the 1st infusion of the T cells. If the WT‐gag‐TCR or the α/6‐gag‐TCR T cells~     are no longer found in the blood after five years, then subjects will be contacted yearly for~     the next 10 years. If the WT‐gag‐TCR or the α/6‐gag‐TCR T cells are found in the blood at~     five years after the 1st infusion of T cells, then the subjects will continue to be seen once~     a year until the WT‐gag‐TCR or the α/6‐gag‐TCR T cells are no longer found in the blood for a~     maximum of 15 years.~   "
196508|NCT00991211|"~     The study addresses the question if the first line therapy of low malignant and mantle cell~     lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus~     rituximab with regard to progression free survival (PFS).~   "
196509|NCT00991198|"~     This study is an evaluation of the role of topical dissolved oxygen to lessen visible signs~     of photodamage using a select regimen of topical dissolved oxygen containing cosmeceutical~     products. Evaluation of the overall skin tolerability of topical dissolved oxygen (safety)~     utilizing the regimen of products.~   "
196510|NCT00991185|"~     The purpose of this study is to learn more about antimicrobials, especially drug levels in~     the CSF that would normally be used in young children as part of standard care. These drugs~     are approved by the Food and Drug Administration (FDA) for treating infections. They are used~     extensively in children in the United States, but they have not been extensively studied in~     children or babies. The investigators do not have very much information on how children and~     babies handle these drugs; that is, how long it takes for the drugs to be removed from the~     blood circulation and to pass out of the body and how much goes into the central nervous~     system. The investigators also do not have good information to guide how often the~     investigators should give the drugs to children and babies to get the maximum effect on~     infections with the minimum amount of drug. Thus, the investigators will collect more~     information about how these drugs should be used in children and babies by doing this drug~     levels research study.~   "
196511|NCT00991172|"~     This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate~     the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with~     sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is~     expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients~     will receive 1 injection under the skin of either active or placebo REGN475, and be followed~     over 10 visits for 12 weeks.~   "
196512|NCT00991159|"~     The study is designed to determine the safety and tolerability of RN316 when administered~     intravenously to healthy adult subjects. This is the first time RN316 has been given to~     humans.~   "
196540|NCT00990795|"~     Administration of cyclosporine has been found to have a myocardial protective effect,~     improving post-operative cardiac function in patients undergoing percutaneous coronary~     interventions by diminishing infarct size. The purpose of the proposed study is to conduct a~     randomized, controlled clinical trial in patients undergoing isolated valvular heart surgery,~     or coronary artery bypass surgery. Specifically the investigators will evaluate the~     cardio-protective effects of cyclosporine on post ischemic-arrest myocardium. The two factors~     will be treatment group and cyclosporine versus placebo.~   "
196513|NCT00991146|"~     To date there are no approved effective therapies for the treatment of cryopyrin-associated~     periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS),~     Muckle-Wells Syndrome (MWS), or Neonatal Onset Multisystem Inflammatory Disease (NOMID) in~     Japan.~      The study will assess the efficacy and safety of canakinumab in Japanese patients with~     cryopyrin-associated periodic syndromes (CAPS). In previous and currently ongoing CAPS~     studies (CACZ885A2102, CACZ885D2201, CACZ885D2304, CACZ885D2306), it has been observed that~     treatment with canakinumab in patients with CAPS contributed to ensure absence of relapse, to~     improve signs and symptoms and to prevent secondary disease complications. However, no~     Japanese patients have been included in those studies. This study will allow access for~     Japanese patients to a new potentially efficacious treatment for CAPS patients with a~     convenient dosing regimen.~   "
196514|NCT00991133|"~     This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase,~     and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric~     patients with first relapse Acute Lymphoblastic Leukemia (ALL).~   "
196515|NCT00991120|"~     The purpose of the Extension Phase of the COMPASS-HF study is to continue to observe the~     safety of the Chronicle® Implantable Hemodynamic Monitor (IHM) system and Chronicle ICD~     system and provide study doctors continued access to the heart pressure information recorded~     by the Chronicle devices which may be used to help manage heart failure. The Extension Phase~     of the COMPASS-HF study is limited to people who have already received the investigational~     system and are currently enrolled in a Chronicle IHM or ICD study.~   "
196516|NCT00991107|"~     The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of~     HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and,~     to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in~     obese insulin-resistant adult subjects.~   "
196517|NCT00991094|"~     The goal of this research study is to collect information on the side effects of proton~     therapy and detailed information on the proton therapy treatment plan itself so that~     researchers can develop methods to predict the risk of side effects for future patients.~      This is an investigational study. Researchers expect to have about 5,000 patients on the~     study. All the patients will be enrolled at MD Anderson.~   "
196518|NCT00991081|"~     The major purpose of this exploratory developmental study will be to develop a~     patient-centered and feasible protocol for communicating genetic data as it relates to drug~     efficacy for smoking cessation inpatients receiving medication that is matched to individual~     genotypes associated with increased efficacy for bupropion or nicotine replacement therapy.~   "
196519|NCT00991068|"~     The purpose of the study is to explore the potential usefulness of Synera for the treatment~     of pain associated with mild to moderate carpal tunnel syndrome.~   "
196520|NCT00991055|"~     The purpose of this trial is to study the efficacy and safety of pioglitazone added to~     combination therapy of sulfonylurea plus metformin with placebo in patients with type 2~     diabetes.~   "
196521|NCT00991042|"~     The purpose of this study is to:~        -  evaluate if there is an association between elevated levels of cytokines and chronic~          pain due to herniated disk disease~        -  measured cytokines levels in chronic low back pain and in healthy subjects.~   "
196522|NCT00991029|"~     A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused~     by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic~     stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor~     ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).~      TIAs are common [25], and are often harbingers of disabling strokes. Approximately~     250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8~     years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in~     fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a~     prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed~     transient neurological events, the true incidence of TIA may be twice as high as the rates of~     diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there~     were an average of 200,000 hospital admissions for TIA each year, with annual charges~     climbing quickly in the period to $2.6 billion in 2003.~      Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or~     ischemic vascular death at 90 days.~   "
196523|NCT00991016|"~     To assess the safety and tolerability of escalating single and multiple doses of the compound~     in healthy volunteers~   "
196524|NCT00991003|"~     Introduction:~      Prevention of colorectal cancer (CRC) is feasible through polypectomy on screening~     colonoscopy. Patient acceptance remains the main limiting factor for execution. Colon capsule~     endoscopy (CCE) might be a novel method for large populations.~      Aims and methods:~      Patients referred for screening means or lower gastrointestinal complaints were included in~     this single center pilot study. They underwent preparation and then ingested the capsule~     (PillCam Colon). Standard colonoscopy was performed the next morning. Significance was~     defined as polyps >5mm in size. Performance of exams was by independent physician with~     blinding of results.~   "
196525|NCT00990990|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium~     that causes tuberculosis (TB) will also be measured. The effect of adding an additional~     tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated.~     Linezolid open label to determine activity in whole blood assay (WBA).~   "
196541|NCT00990782|"~     This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a~     patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus~     has not been established.~   "
196542|NCT00990769|"~     The purpose of this study is to determine whether depth of anesthesia has an effect on~     emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric~     patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of~     anesthesia on EA has not been studied. The study will randomize 40 children undergoing~     ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or~     deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of~     Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a~     scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.~   "
196526|NCT00990977|"~     The number of Danish women treated for breast cancer rise every year, though survival rates~     have improved, women can still expect to experience the diverse late effects reported by this~     group of patients. Mindfulness labels the ability to be aware of the present moment - thereby~     avoiding speculations about both past and present. Mindfulness based stress-reduction (MBSR)~     is an 8-week program, covering 24 contact-hours and 45 minutes daily home practice. The~     program aims at developing participants' coping resources and developing participants'~     mindful awareness. Thus the program consists of guided meditations, guided body scan(a~     specific awareness exercise)and through meditation, yoga and psychoeducation concerning~     stress and stress-reactions, while meditation and bodyscan is practiced at home by the use of~     specific audio-CDs guiding the patient. The MBSR-program have shoved promising results among~     patients with anxiety-disorders, depression and chronic pain. Smaller studies have also found~     positive effects of the program among cancer patients. The investigators want to evaluate the~     effect of the MBSR program on levels of anxiety and depression as well as the possible~     influence of mindfulness training on health behaviors and existential concerns. The study are~     based on the following hypotheses:~        -  report of anxiety and depression will decrease among cases~        -  better compliance will lead to more decrease in levels of anxiety and depression~        -  cases will make lifestyle changes suitable with recommendations for BC patients in~          post-treatment phase of the illness~        -  decreased level of anxiety and depression will reflect improved spiritual well-being~        -  improved spiritual wellbeing will lead to decreased report of physical symptoms~      All participants in this randomized controlled trial will fill out questionnaires at~     enrollment and as 1, 6 and 12 months follow-up. Based on results from this trial clinicians~     and patients will be able to make decisions regarding post-treatment psychosocial~     intervention and researchers will have initial evidence of the effect of the intervention and~     thus possible indications for research on mindfulness among patients diagnosed with cancer at~     other stages or sites.~   "
196527|NCT00990964|"~     The purpose of the study is to assess lead implant success and complication rate using the~     Medtronic Attain Family of left-heart leads and delivery catheters.~   "
196528|NCT00990951|"~     The purpose of this study is to evaluate the efficacy of association of Senna alexandrina~     Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra~     mediterranea Taub. in patients with functional constipation.~   "
196529|NCT00990938|"~     Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose~     levels of IMO-2125 in combination with standard weight based ribavirin (investigational~     treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients~     will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo~     and RBV arm (3 patients).~   "
196530|NCT00990925|"~     The purpose of this study is to find out how effective lifestyle modification group therapy~     is on reducing body weight when compared to usual care in individuals with schizophrenia~     and/or schizoaffective disorder.~   "
196531|NCT00990912|"~     The purpose of this study is to determine the long term safety of patients with refractory~     solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in~     BMS Protocol CA124-001 or CA124-002.~   "
196532|NCT00990899|"~     The primary objective is to determine the prevalence of sleep disordered breathing in~     children with primary hypertension or pre hypertension. The secondary objectives are to~     determine any association factors for children with primary hypertension or prehypertension~     to have sleep disordered breathing be it gender, age, body mass index (BMI), family history~     (hx) or ethnic group.~   "
196533|NCT00990886|"~     The objective of this study is to evaluate the safety and efficacy of extended-release~     oxybutynin chloride for the treatment of vasomotor symptoms, also known as hot flashes, in~     healthy naturally postmenopausal women. This is a randomized, double-blind, multi-center,~     parallel group, placebo-controlled study evaluating the safety and efficacy of~     extended-release oxybutynin chloride on hot flashes in healthy naturally postmenopausal~     women. Patients will be randomized to extended-release oxybutynin chloride or placebo in a~     1:1 ratio. The total duration of the study for each treatment group is approximately 98 days.~     Patients will be seen for their Pre-Randomization Visit (Visit 1) fourteen (14) days prior to~     randomization and a physical examination, medical history, hot flash history, vital signs and~     laboratory tests will be performed. Patients will also have daily diaries dispensed to record~     their hot flashes (frequency for each severity). Patients who meet the eligibility criteria~     for this study will be randomized at Visit 2. At this visit, patients will have vital signs~     taken, adverse events recorded, study medication dispensed, and complete Quality of Life~     (QOL) questionnaires. The patient will be instructed to start her study medication beginning~     the morning after this visit (defined as Study Day 1). In both treatment groups, patients~     will return for follow-up visits between Study Days 8-14 (Visit 3), 22-28 (Visit 4), and~     50-56 (Visit 5). The Final Study Visit (Visit 6) will occur between Study Days 78-84.~   "
196534|NCT00990873|"~     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer~     may help doctors identify biomarkers related to cancer. It may also help doctors predict how~     patients will respond to treatment.~      PURPOSE: This research study is looking at tissue samples from patients with stage I~     non-small cell lung cancer enrolled on research study CALGB-140202.~   "
196535|NCT00990860|"~     TACE possibly plays a significant role in contributing to a subgroup of surviving residual~     tumor tissue which is characterized by more aggressive biology. This explains the strong~     scientific rationale for exploring the role of anti-angiogenic therapy such as sorafenib to~     remedy and strengthen the therapeutic efficacy of TACE to combat liver cancers. Sorafenib~     plays a prominent auxiliary role by further suppressing the tumor growth and prolonging the~     time to recurrence and progression. Performing TACE under sorafenib administration may have~     synergic effect on hepatic tumoral lesions.~   "
196536|NCT00990847|"~     The purpose of this study is to compare the efficacy and safety of nebule procaterol with~     nebule salbutamol in the treatment of moderate acute asthma.~   "
196537|NCT00990834|"~     The purpose of this study is to investigate the mechanism of statin-related myopathy by~     evaluating muscle samples before and after statin exposure.~   "
196538|NCT00990821|"~     This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two~     formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults.~     Parts I to IV of this study will examine different doses of MK-0517 as well as two different~     formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare~     single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The~     primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or~     115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg~     oral aprepitant capsule in young healthy participants.~   "
196539|NCT00990808|"~     This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with~     dyslipidemia already on statin therapy.~   "
196546|NCT00990717|"~     The purpose of this study is to find out how many irradiated natural killer (NK) cells can be~     safely given to patients with cancer that has recurred after an autologous stem cell~     transplant, and to see what effects (good and bad) it has on the patient and their cancer.~     This research is being done because currently, there is no cure or effective treatment for~     blood-borne cancers when it has come back after an autologous stem cell transplant.~   "
196547|NCT00990704|"~     This study is a exploratory comparison of the efficacy and safety of paricalcitol injection~     with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis~     with secondary hyperparathyroidism.~   "
196548|NCT00990691|"~     Rett syndrome is a neurodevelopmental disorder characterized by cognitive impairment,~     communication dysfunction, stereotypic movement disorder, and growth failure. Rett syndrome~     is caused by mutations in the Methyl CpG-Binding Protein-2 (MECP2) gene and has no treatment.~      A mouse experimental model of Rett syndrome created by genetic invalidation of the MECP2 gene~     is available. It had been then observed that adult MECP2-deficient mice show respiratory~     alterations and found that endogenous noradrenaline helps to maintain a normal respiratory~     rhythm. Desipramine, a selective inhibitor of norepinephrine reuptake, seems to be efficient~     to reduce the respiratory alteration occuring in MECP2-deficient mice (Insem patent 2005,~     Villard and Roux 2006).~      The aim of the study is to evaluate these obtained results in MECP2-deficient mice on~     patients with Rett syndrome.~   "
196549|NCT00990678|"~     The investigators want to investigate if HIV sero-positive males benefit from vitamin D~     supplementation. The study runs in 16 weeks and the participants are treated with one of~     three placebo controlled regimes (tablets):~        1. Calcium~        2. Calcium and 25-hydroxy-vitamin D~        3. Calcium and 25-hydroxy-vitamin D and 1,25-dihydroxyvitamin D~      The endpoints are:~        -  Serum vitamin D~        -  Parathyroid hormone~        -  ionized calcium~        -  T-lymphocyte fractions (naïve, mature, Tregs)~        -  Osteocalcin (bone metabolism)~   "
196550|NCT00990665|"~     The objective of this study is to assess the safety and efficacy of the Quartet™ lead and~     Promote Q® device system in a patient population indicated for cardiac resynchronization~     therapy.~   "
196551|NCT00990652|"~     Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     bortezomib before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed. Giving bortezomib together with temozolomide after surgery may kill~     any tumor cells that remain after surgery.~      This phase II trial is studying how well giving bortezomib before surgery followed by giving~     bortezomib together with temozolomide after surgery works in treating patients with recurrent~     malignant glioma.~   "
196552|NCT00990639|"~     Background:~      Alcohol is one of principal causes of hepatic fibrosis. Although the most effective treatment~     for alcoholic hepatic fibrosis is abstinence of alcohol consumption, additive treatment to~     reduce the accumulation of scar tissue can accelerate the improvement of hepatic fibrosis in~     alcoholic liver disease. The renin-angiotensin system can be an attractive antifibrotic~     target in liver. Several lines of evidence indicate that overproduction of angiotensin II(ANG~     II) in chronic liver injury stimulates the activation of hepatic stellate cells(HSCs)~     attributed to fibrogenesis. Additionally, the antifibrotic effect of ANG II blocking agent~     has been shown in various animal models and hepatitis C patients. Hence, drugs that inhibit~     the renin-angiotensin system have promise in ameliorating hepatic fibrosis in chronic liver~     injury. However, no study has been conducted in patients with alcoholic liver disease to~     evaluate the effect ANG II type I receptor blocking agent on hepatic fibrosis.~      Aim:~      This study aimed to investigate the safety and the efficacy of chronic administration of~     candesartan to hepatic fibrosis patients with alcoholic liver disease.~      Methods~      1) Patients with liver fibrosis(F2) were randomized to receive either the angiotensin~     receptor blocker(ARB), candesartan(8 mg/day) with ursodeoxycholic acid(UDCA)(600 mg/day)(n =~     42), or UDCA alone(n = 43) as control for 6 months. 2)All enrolled patients underwent liver~     biopsies twice for measurement of fibrosis score, area of fibrosis and alpha-smooth muscle~     actin(SMA) positive and hydroxyproline. 3) Transforming growth factor-beta1(TGF-beta1),~     collagen-1, angiotensin II type I receptor(AT1-R), tissue inhibitor of~     metalloproteinase-1(TIMP-1), Rac1 and p22phox which represent oxidant stress were also~     measured by real-time RT-PCR before and after 6 months of therapy.~   "
196553|NCT00990626|"~     The purpose of the study is to determine whether the Seroquel XR treatment for 6 months~     improve the relapse prevention in schizophrenic outpatients~   "
196554|NCT00990613|"~     To estimate the absorption, safety, and tolerability of a dimebon transdermal solution~     relative to the dimebon immediate release oral formulation.~   "
196555|NCT00990600|"~     Primary objective of the study is:~      To verify if simplification of the antiretroviral regimen, measured as the reduction of pill~     burden alone, may affect adherence rate of patients.~   "
196556|NCT00990587|"~     This is an open-label, single arm study. Approximately 3-30 patients will be enrolled.~     Patients will receive Oral ciclopirox olamine (aqueous suspension), initial starting dose of~     5 mg/m2/day administered as a single dose daily for 5 days. Three patients will initially be~     treated at each dose level in sequential cohorts. Dose escalation will continue for each~     subsequent cohort based on toxicity and plasma drug concentrations observed during the~     previous cohort. Dose escalation will continue until establishment of the maximum tolerated~     dose (MTD) has been met.~      Patients who have demonstrated response to treatment, up to 6 total cycles of treatment may~     be administered. If additional cycles are warranted, ciclopirox olamine will be given at the~     same dose and frequency as the patient initially received.~   "
196557|NCT00990574|"~     The purpose of this study is to compare single shot versus sequential bolus spinal technique~     via a catheter in patients undergoing Cesarean Section. We aim to determine which technique~     results in less blood pressure reduction and subsequent vasopressor use.~      Other study endpoints include the incidence of maternal post dural puncture headaches and~     nausea and vomiting. In addition blood and CSF will be collected to see if biochemical~     mediators are related to wound hyperalgesia and healing.~   "
196575|NCT00990327|"~     The purpose of this study is to see whether apadenoson is as effective as adenosine when used~     as a pharmacological stress agent in myocardial SPECT-Imaging to detect defects in the supply~     of blood to the heart muscle (myocardial perfusion defects). The study will also look at~     whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.~   "
196576|NCT00990314|"~     This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and~     have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release~     (BPS-MR) tablets.~   "
196558|NCT00990561|"~     This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy~     of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate~     0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the~     treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with~     combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis~     plaques will be evaluated to test efficacy of the medication. Half the subjects will be~     randomized to receive treatment with once a day Ultravate® ointment and twice daily~     Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment~     with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two~     weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment~     phase will consist of a four-week observation period. Subjects will be re-randomized to~     either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this~     second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily~     can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this~     clinical study consists of the use of patient and physician satisfaction questionnaires.~     These questionnaires will include questions about the satisfaction with the formulation of~     each agent, questions about compliance with treatment, etc. Such questions could be used to~     demonstrate patient and physician satisfaction with each agent, with combination therapy, and~     to compare patient satisfaction rates among those randomized to once daily versus twice daily~     application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in~     combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice~     daily in combination with Lac-Hydrin twice daily.~   "
196559|NCT00990548|"~     The purpose of the FIT-O study was to estimate the prevalence of having a caregiver (paid~     and/or informal) among hospitalized cardiac patients by demographic factors such as patient~     age and race/ethnicity, and to link caregiver status to clinical outcomes following~     hospitalization. A secondary aim was to collect anonymous family tree data to provide an~     estimate of the number of first degree family members, their basic demographics, and the~     distance at which they live from the medical center.~   "
196560|NCT00990535|"~     Octreotide (OCT) is a somatostatin analogue (SSA) available in a long-acting formulation,~     conventionally administered every 28 days at the maximum dose of 30 mg. Together with~     lanreotide, it is considered the therapy of choice in the control of endocrine syndromes~     associated with neuroendocrine tumors (NET)s. A complete or partial clinical response to SSA~     therapy is generally achieved in at least 50% of the patients with neuroendocrine syndrome.~     Many studies reported a clinical response in 70-90% of functioning NETs. In about 36-50% of~     the patients with progressive advanced well differentiated NET (WDNET), a stabilization of~     disease occurs after treatment with subcutaneous OCT. By developing long-acting slow-release~     SSA formulation, long-acting OCT (LAR), lanreotide-SR, lanreotide-Autogel, the patient's~     compliance to SSA therapy was improved and escape from treatment, which was common with the~     subcutaneous formulation, was avoided. However, rate of objective response was not~     significantly improved as compared to short-acting SSA. On the other hand, it has to be~     remarked that long-acting SSA are being used in NET patients at doses correspondent to the~     low doses of short-acting formulation. The higher commercially available doses of LAR is 30~     mg, which is assumed to be comparable to 300 µg of short-acting OCT in the therapy of~     acromegaly.~      Only one study was designed to investigate the use of high-dose LAR (160 mg every 28 days).~     In this study, objective and hormonal responses in patients with progressive metastatic ileal~     NET non-responder to standard doses, was significantly elevated. However, this compound has~     never been commercialized and, of consequence, this first preliminary observation has not~     been confirmed by further studies.~      No systematic studies were performed with the commercially available long-acting SSA used in~     high-dose treatments. In patients with progressive locally advanced or metastatic NET,~     increase of the dose or reduction of the interval between injections is a relatively common~     empirical clinical practice, but no studies have been performed to evaluate safety and~     efficacy of this treatment schedule.~   "
196561|NCT00990522|"~     Standard care of care and up to twelve (12) weekly debridements. Subjects randomized into the~     weekly debridement group will receive up to twelve (12) debridement during the twelve (12)~     weeks of the study. There will be two (2) subject groups in the study. Subjects will be~     randomized into either the monthly debridement group or the weekly debridement group.~   "
196562|NCT00990509|"~     The purpose of this study is to find out what effects, good and bad, the medication Albumin~     has on subjects who have experienced a type of stroke known as an intracerebral hemorrhage~     (ICH). An ICH is when spontaneous bleeding into the brain occurs due to fragile blood~     vessels.~      This research is being done because currently there is no effective treatment for ICH.~     However, study investigators believe that Albumin, the medication being tested in this study,~     is safe and may help improve patient recovery from ICH over time.~      Subjects will be enrolled in the study for a total of 90 days. Following enrollment, subjects~     will be randomized to receive 3 daily injections of either Albumin or Placebo (liquid with no~     drug), and will receive 3 brain MRI scans (with and without contrast), as described below.~      All subjects will be monitored continuously through 96 hours after enrollment (5 days) in the~     Georgetown ICU. Blood tests and clinical evaluations of neurological status, consisting of~     questions about subjects' functional abilities and medical history, will occur in the~     Georgetown ICU once every 24 hours through post-enrollment Day 5. Additionally, subjects will~     receive daily chest x-rays, and daily EKGs (exams that monitor how your heart is doing by~     placing electrodes, or small monitors, on your skin in specific locations).~      Similar clinical evaluations will occur at Day 30 and Day 90. Should subjects be discharged~     at these time points, day 30 assessments will occur over the phone, and day 90 assessments~     will occur in-person at Georgetown University Medical Center.~   "
196563|NCT00990496|"~     The primary purpose of this study is to determine the safety and efficacy of the infusion of~     partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM~     that have failed primary therapy.~   "
196564|NCT00990470|"~     In consideration of the limited supply of donor organs, the careful selection of transplant~     candidates is essential to optimize patient outcome after transplantation. Therefore an~     extensive evaluation of transplant candidates including among others~     esophagogastroduodenoscopy (EGD) and colonoscopy has been implemented in our centre. The data~     regarding the prevalence of upper and lower gastrointestinal (GI) pathology in transplant~     candidates are contradictory and are based on only a few retrospective studies, which often~     include only a subgroup of transplant candidates. The goal of this project is a prospective~     evaluation of the frequency of GI pathologies in transplant candidates with specific focus on~     the following questions:~        1. Are there GI-pathologies that occur at a higher prevalence in transplant candidates than~          described in the general population and is there an increase of GI-pathologies since the~          introduction of the urgency-based organ allocation leading to sicker transplant~          candidates?~        2. What is the influence of endoscopic findings on patient management before~          transplantation?~        3. Which risk factors can be identified that predict the presence of GI-lesions?~        4. Is there a subgroup of patients, in which screening colonoscopy before liver~          transplantation can not be recommended considering the cost/benefit ratio?~        5. Is there a correlation of endoscopic findings with outcome after liver transplantation~          or with gastrointestinal complications during or after transplantation (e.g.~          gastrointestinal bleeding, perforation or gastrointestinal malignancy)?~   "
196565|NCT00990457|"~     Abdominal obesity, which is affected by a lack of physical activity and excess weight, put~     people at an increased risk of cardiovascular disease. This study will compare the effects of~     two different dietary approaches to weight loss, each combined with exercise, for their~     effects on cardiovascular factors that are early predictors of future cardiovascular disease~     in overweight and obese people with excessive weight around their waist. The two diets are a~     low-carbohydrate versus a more traditional low-fat, low calorie diet.~   "
196566|NCT00990444|"~     Insulin is normally not bioavailable when taken through the oral route, as degradation of the~     molecule may occur both in the ventricle and in the intestine. Oral administration with~     uptake from the lesser intestine would offer major advantages if made possible. It would~     offer a simple non-injection method to administer insulin in connection with a meal and~     absorbed insulin would enter the blood stream and mimic the natural distribution in the body~     with a first pass through the liver. The sponsor of this study has developed a novel oral~     insulin formulation that is based on a proprietary dextran matrix. The investigational drug~     is a capsule containing 100 IU of human insulin in dextran matrix.~      The primary objective of this study is to establish the safety, tolerance and PD profile~     (i.e. pharmacodynamic parameters for glucose and insulin) of peroral insulin in dextran~     matrix in patients with type 2 diabetes.~      The phase I/II study protocol consists of two parts; part 1 (dose finding) and part 2 (dose~     verification). In study part 1 single escalating doses of oral insulin or placebo is given to~     the test subjects. Capillary blood glucose is used to assess the insulin effect.~     Subsequently, in study part 2, the investigational drug will be administered 3 times daily on~     6 consecutive days. The starting dose of part 2 will be the lowest effective dose found in~     study part 1. Dose escalation will be done in increments of 100 IU. The total number of~     subjects will be 32 (for part 1 and 2 combined).~   "
196567|NCT00990431|"~     Ablative fractional lasers were introduced for treating facial rhytides in an attempt to~     achieve results comparable to traditional ablative resurfacing but with fewer side effects.~     However, there is conflicting evidence on how well this goal has generally been achieved as~     well as on the comparative value of fractional CO2 and Er:YAG lasers. The present study~     compares these modalities in a randomized controlled blinded split-face study design:~      28 patients were enrolled and completed the entire study. Patients were randomly assigned to~     receive a single treatment on each side of the peri-orbital region, one with a fractional CO2~     and one with a fractional Er:YAG laser. The evaluation included Fitzpatrick wrinkle score,~     profilometric measurement of wrinkle depth (both before and 3 months after treatment) as well~     as assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after~     treatment).~   "
196568|NCT00990418|"~     The purpose of this study is to confirm that the two forms of the device the Integrated~     E-TRANS (fentanyl HCl) system and the Separated (Two-Part) E-TRANS (fentanyl HCl) System~     provide the equivalent blood levels of medication (fentanyl HCL).~   "
196569|NCT00990405|"~     The role of Helicobacter pylori infection in functional dyspepsia remains controversial.~     Several randomized controlled trials in western countries have shown no significant advantage~     over placebo. But some recent studies in Asian population were different compared to the~     result of studies in the Western population. At the present time, it seems to be difficult to~     conclude the efficacy of the H.pylori eradication therapy in patients with H. pylori-infected~     functional dyspepsia.~      The investigators hypothesize that eradication of Helicobacter pylori has a sustained global~     symptom improvement in patients with H. pylori infected functional dyspepsia.~   "
196570|NCT00990392|"~     The purpose of the study is to determine if the overall central venous catheter related~     infection rate can be reduced by the application of Polysporin Triple Therapy ointment to the~     insertion site.~   "
196571|NCT00990379|"~     This pilot study will assess the feasibility of using heavy water as a safe 'tracer' for~     biomarker studies of diseases of the brain and spinal cord, that, together, are also called~     the central nervous system (CNS). Heavy water, also called deuterated water or D20, is the~     same as normal drinking water except the hydrogen atoms have been replaced by deuterium, a~     naturally occurring isotope of hydrogen. In particular, this study will use heavy water to~     define: 1) The rate of immune cell proliferation (growth) in the cerebrospinal fluid (CSF)~     compared to blood. This study will be examining a particular type of immune cell called T~     lymphocytes. 2) This study will also examine selected molecules generated by nerve cells of~     the CNS to understand their rate of secretion and turnover in healthy control participants,~     HIV-1-infected participants and participants with a non-HIV-related neurodegenerative disease~     such as Parkinson's disease (PD).~      This study will involve the administration of heavy water orally for either seven days, 12~     days or six weeks. Measurements will be taken by lumbar puncture (LP, also known as a spinal~     tap). Blood (approximately five tablespoons per visit) will also be obtained at each of the~     lumbar puncture appointments.~      If this method can be used to establish the rates of immune cell turnover and the production~     rates of neuronal molecules using cerebrospinal fluid, it will provide unique data that is~     important to understand chronic neurodegenerative conditions, like PD, and to measure~     responses to targeted therapies.~      Hypothesis:~        1. D2O, administered orally, can be used to measure the proliferation rates of CSF T cells~          (and, eventually, of their major phenotypic subsets).~        2. D2O can be used to assess the turnover and production rates of CNS constituents that are~          normally or pathologically shed or secreted into the CSF, including (eventually): cargo~          molecules transported specifically in neurons in the CNS, such as chromogranin-A and -B,~          neuregulin-1 (specifically the extracellular secreted ectodomain of neuronal~          differentiation factor (NDF) isoform type α1, α2, β1, and the acetylcholine receptor~          inducing activity isoform (ARIA), secreted amyloid precursor protein (sAPP),~          alpha-synuclein; and APP metabolites amyloid beta (Aβ) 41 and 42.~   "
196572|NCT00990366|"~     Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage~     (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids~     through a stent is thought to be one of the causes of cholangitis. Stents with antireflux~     valves are designed to reduce the reflux from the bowel. The purpose of the study is to~     investigate prospectively whether it is possible to reduce the amount of infection and thus~     obstruction of biliary stent by using a stent with an antireflux valve compared to a normal~     stent without an antireflux valve.~   "
196573|NCT00990353|"~     This study examines methods to better predict improvement of a hidden disability of~     functional vision, spatial neglect, following stroke. Spatial neglect is a tendency to make~     visual judgment and movement errors mislocating the body and objects in space. The~     investigators are using specialized statistical methods to compute the proportion of~     improvement accounted for by personal characteristics of each stroke survivor, the proportion~     of improvement accounted for by the unique visual-spatial errors made by each subject, and~     the proportion of improvement accounted for by each treatment administered. The investigators~     will also examine whether brain imaging predicts how rapidly improvement occurs. Lastly, the~     study tests whether improvements that are meaningful to the survivor can be measured in a way~     that still allows detection of small and scientifically eloquent performance changes.~   "
196574|NCT00990340|"~     The purpose of this study is to obtain psychological response and user preference information~     on the use of the T jet® device versus the traditional subcutaneous injection administration~     of Tev Tropin®.~      This study will compare subject-reported injection anxiety immediately before the~     administration of each dose of Tev-Tropin® between a needle-syringe injection method and a~     needle-free injection method (T-jet®)~   "
196577|NCT00990301|"~     The purpose of this study was to evaluate the relative bioavailability of Paddock~     Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets~     with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets,~     under fasting conditions.~   "
196578|NCT00990288|"~     The purpose of this study is to determine if the agent, Floseal, can decrease the amount of~     blood patients lose after total knee replacement (TKR) surgery. If this product can be found~     to have an effect on bleeding, it may potentially reduce the problems associated with~     bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood~     transfusion. The subject's overall participation will be over a period of 6 weeks.~   "
196579|NCT00990275|"~     Alcohol has well-established consequences in the lung including increased risk for upper~     respiratory tract infections, pneumonia and acute respiratory distress syndrome (ARDS). There~     have even been a few reports of alcohol-induced asthma. Data from the investigators'~     laboratory have established that the airways are specifically impacted by alcohol exposure.~     Because the airways are heavily exposed to the vapor phase of alcohol during drinking and~     airway motor tone is modulated by cAMP, the investigators speculated that airway bronchial~     motor function would be altered in mice fed alcohol. The investigators' preliminary studies~     demonstrate that brief alcohol administration significantly attenuates airway~     hyperresponsiveness (AHR) in a mouse model. This novel finding has led us to hypothesize~     that:~      Alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.~   "
196580|NCT00990262|"~     The goal of this research is to determine noninvasively whether detection of coronary~     stenosis and plaque by multidetector computed tomography (MDCT) in patients with acute chest~     pain suspected of acute coronary syndrome (ACS) enhances triage, reduces cost and is cost~     effective. Among the 5.6 million patients with ACP presenting annually in emergency~     departments (ED) in the United States, a subgroup of two million patients is hospitalized~     despite normal initial cardiac biomarker tests and electrocardiogram (ECG). This subgroup is~     at low (20%) risk for ACS during the index hospitalization. Most (80-94%) patients with a~     diagnosis of ACS have a significant epicardial coronary artery stenosis ( >50% luminal~     narrowing). However, in -10% of patients non-stenotic coronary plaque triggers events, i.e.~     vasospasms, leading to myocardial ischemia. Since the absence of plaque excludes a coronary~     cause of chest pain, these patients could in theory be discharged earlier reducing~     unnecessary hospital admissions. Recent publications demonstrate high sensitivity and~     specificity of MDCT for the detection of significant coronary stenosis compared with coronary~     angiography and the detection of coronary plaque as validated with intravascular ultrasound.~     Using 64- slice MDCT we propose to study 400 patients with ACP, negative initial cardiac~     biomarkers and non-diagnostic ECG. We will analyze MDCT images for the presence of~     significant coronary artery stenosis and plaque and correlate the data with the clinical~     diagnosis of ACS (AHA guidelines) during the index hospitalization to determine the~     sensitivity and specificity. MDCT data, risk factors, and the results of standard diagnostic~     tests available at the time of MDCT will be used to generate a multivariate prediction~     function and derive a clinical decision rule. Based on this decision rule we will compare the~     diagnostic accuracies and cost effectiveness of competing strategies. We hypothesize that an~     MDCT- based diagnostic strategy will reduce the time to diagnosis of ACS, number of~     hospitalizations, and absolute cost of management of patients with acute chest pain compared~     to standard clinical care and is cost effective.~   "
196581|NCT00990249|"~     The goal of this clinical research study is to test the safety of giving clofarabine in~     combination with busulfan, followed by an allogeneic (from a donor) stem cell transplant, in~     patients with advanced leukemia or lymphoma.~   "
196582|NCT00990236|"~     The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many~     times enoxaparin (or Lovenox®) is given to patients who are at a higher risk of developing~     clots in their legs or lungs. Recent data suggest that a standard dose of Lovenox may not~     fully prevent the development of these clots especially in critically ill or obese patients.~     Routine enoxaparin dosing can also result in bleeding complications. Thrombelastography~     (TEG®) can be used to measure how blood clots. The purposes of this study are:~        -  to learn if the TEG® can better guide physicians in prescribing an effective dose of~          Lovenox compared to standard doses recommended by the drug company in preventing blood~          clots from developing in the legs and lungs, and~        -  to compare the development of blood clots in patients receiving the standard dose of~          enoxaparin compared to patients receiving a TEG® guided dose of enoxaparin.~        -  to determine if TEG guided dosing results in decreased bleeding complications compared~          to standard dosing.~   "
196583|NCT00990223|"~     To evaluate the changes in serum aldosterone and plasma renin activity on Day 0 and on Days 1~     and 10 after administration of 100 mg of eplerenone daily for 10 days.~   "
196584|NCT00990197|"~     Continuing to smoke after having a heart attack greatly increases the risk of death and~     cardiac illness. The nicotine patch is a commonly used pharmacotherapy for smoking cessation~     and has great potential to help heart attack patients quit smoking. However, due to safety~     concerns, physicians are often hesitant to prescribe the nicotine patch to patients who have~     just suffered a heart attack. The STADIA pilot study will assess the feasibility of a~     large-scale clinical trial investigating safety and efficacy outcomes associated with the~     nicotine patch immediately following a heart attack. Eligible subjects will be randomized~     within 48 hours of suffering a heart attack to wear a transdermal nicotine patch on either~     day 1 or day 2 of the study period. The nicotine patch will deliver nicotine to the patient~     over the period of 24 hours. Patients will be advised to discuss smoking cessation strategies~     with their treating physician and subsequent care will be left to the discretion of this~     physician. The duration of ischemia (loss of blood flow in the heart), patient adherence,~     incidence of arrhythmia (disorder of the heart rate or rhythm), heart rate, and blood~     pressure within the two groups will be used to evaluate the safety of transdermal nicotine~     use immediately after a heart attack.~   "
196585|NCT00990184|"~     The objective of this study is to determine the effect of 8 weeks of treatment with~     colesevelam HCl 3.75 g once daily with the evening meal on ß-cell function by evaluating the~     acute insulin response (AIRg) to an intravenous glucose load in subjects with prediabetes~     (impaired fasting glucose).~   "
196586|NCT00990171|"~     A prospective long-term follow up of peritoneal dialysis patients' outcome correlates with~     nutritional status and body composition.~   "
196587|NCT00990158|"~     Warfarin is highly effective for the prevention of both first and recurrent thrombotic~     events, however even minor excursions outside the reference INR range of 2.0 to 3.0 are~     associated with bleeding or thrombotic complications. The importance of maintaining the INR~     within the desired interval has led to the concept of time in therapeutic range (TTR) - the~     total proportion of time that the INR is between 2.0 and 3.0. The investigators propose a~     multicentre, double blind, randomized trial which will determine if 0.150 mg of oral vitamin~     K increases time in the therapeutic range for patients receiving warfarin.~   "
196589|NCT00990132|"~     This study is designed to investigate the effect of home mechanical ventilation (HMV) in~     patients with severe chronic obstructive pulmonary disease (COPD). The purpose of the trial~     is to test the hypothesis that HMV and longterm oxygen therapy (LTOT) increases admission~     free survival compared with LTOT alone. More specifically, compared with LTOT, HMV and LTOT~     reduces hospital re-admission in COPD patients who remain persistently hypercapnic following~     an acute exacerbation requiring non-invasive ventilation (NIV).~   "
196590|NCT00990119|"~     The aim of this study is to see if the Vapotherm High Flow Therapy (HFT) device is effective~     to provide breathing support to patients with Chronic Obstructive Pulmonary Disease or COPD.~     The investigators believe that patients using HFT will not require as much use of therapies~     that provide pressure through a face mask, and are already recognized by FDA as support~     therapies for respiratory insufficiency.~   "
196591|NCT00990106|"~     The purpose of this study is to determine whether prazosin will:~        -  reduce the incidence of nightmares and sleep disturbance~        -  increase functioning and sense of well being in combat-trauma exposed Operation Iraqi~          Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.~   "
196592|NCT00990093|"~     The purpose of this study is to evaluate that the test catheter is no less accepted than the~     SpeediCath (SC) catheter.~   "
196593|NCT00990080|"~     To demonstrate the safety and immunogenicity of two mixed primary immunization schedules:~     Pediacel® at 2 and 4 months of age followed by one dose of Infanrix™ IPV/Hib at 6 months of~     age; and, Infanrix™ IPV/Hib at 2 months of age, followed by Pediacel® at 4 and 6 months of~     age.~   "
196594|NCT00990067|"~     The purpose of this study is to determinate the effect of a pre-treatment with the combined~     serotonin (5-HT) and norepinephrine (NE) transport blocker duloxetine on the pharmacodynamics~     and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The~     investigators hypothesize that duloxetine will attenuate the subjective and cardiovascular~     response to MDMA.~   "
196595|NCT00990054|"~     The purpose of this research study is to determine if plerixafor can make cells more~     sensitive to killing by cytarabine and daunorubicin, an anti-cancer drug regimen referred to~     as 7+3 that is commonly used in treating acute myeloid leukemia (AML). In this study,~     plerixafor is used with treatments cytarabine and daunorubicin and with and without~     granulocyte-colony stimulating factor (GCSF). Subjects will be monitored to see how well they~     tolerate the use of these drugs together and how well they work to treat the leukemia.~      The purpose of the study is to determine the maximum tolerated dose (MTD) per plerixafor~     dosing schedule (once daily [QD] or twice daily [BID]), and/or recommended phase 2 dose~     (RP2D), by assessing safety and tolerability of plerixafor (Mozobil®) when used in~     combination with cytarabine and daunorubicin, and with and without granulocyte-colony~     stimulating factor (G-CSF)~   "
196596|NCT00990041|"~     Background and Objective: It has been reported that peripheral blood mononuclear cells (PBMC)~     from periodontal patients have a different profile of cytokine release when compared to the~     ones of healthy patients. Cigarette smoking is a recognized risk factor for periodontitis and~     is known to affect the systemic and local immune responses. Thus, the aim of the present~     study was to obtain preliminary data about the interaction of periodontal condition and~     smoking in the secretion of some cytokines by PBMC.~      Material and Methods: PBMC samples were isolated from 19 donors, divided into generalized~     chronic periodontitis (P; n=10) and periodontal health (H; n=9) groups. In addition, the~     smokers and non-smokers of each group were separately evaluated: SP- smokers with severe~     generalized chronic periodontitis (n=5); SH- periodontally healthy smokers (n=5); NSP-~     non-smokers with severe generalized chronic periodontitis (n=5) and NSH- periodontally~     healthy non-smokers (n=4). Cells were incubated for 24-48 hours in 500 µL wells containing~     RPMI 1640 and stimulated with 1.0 ng/mL of E. coli LPS. Supernatants were used to quantify~     the amounts of TNF-α, IL-6, IL-8 and IL-10 released using ELISA kits.~   "
196597|NCT00990028|"~     The purpose of this study is to determine whether rosuvastatin could alter the immunological~     response after head injury by modulating TNF-alpha,IL6,IL-1.~   "
196598|NCT00990015|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics~     (understanding how a drug is absorbed and moves through the body) and pharmacodynamics~     (understanding the effects of a drug on certain target sites of activity in the body).~   "
196599|NCT00990002|"~     Investigating different bioactive ingredients in children's beverages and the effect on blood~     serum markers.~   "
196600|NCT00989989|"~     This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as~     adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian~     patients with visual impairment due to Diabetic Macular Edema (DME).~   "
196601|NCT00989976|"~     The hypothesis for this study is that some individuals may be at much higher risk to develop~     type 2 diabetes and that the individual diabetes risk will be predicted by the individual~     level of slow wave sleep activity (SWA).~   "
196602|NCT00989963|"~     This is a 12-week, international, multicenter, double-blind, three-group, dose-response study~     to assess the safety and efficacy of BPS-MR in patients with PAH. Eligible patients will have~     been previously diagnosed with PAH and will be on a stable course of an ERA and/or PDE-5~     inhibitor for at least 60 days prior to Baseline.~      Patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio and will be~     stratified by PAH background therapy (Endothelium Receptor Antagonist (ERA),~     Phosphodiesterase-5 (PDE-5), and both). The treatment groups consist of one Maximum Tolerated~     Dose (MTD) and two Fixed Dose (FD) groups. Following randomization, patients will begin~     taking active drug (60µg) orally twice daily. Patients will visit their investigational site~     at Week 6 and Week 12 for study evaluations.~   "
196603|NCT00989950|"~     Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana~     (methylphenidate) patch for a longer time then 9 hours, many children report short sleep~     latencies and better quality of sleep.~   "
196604|NCT00989937|"~     The objective of the study is to compare the efficacy of intranasal oxytocin versus~     intranasal placebo to improve anxiety symptoms in patients with a variety of anxiety~     disorders.~   "
196605|NCT00989924|"~     The purpose of this study is to evaluate the correlation among magnetocardiography (MCG)~     patterns and various known cardiovascular risk factors.~   "
196606|NCT00989911|"~     Recent studies have shown beneficial effects of sildenafil in patients with single ventricle~     congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug~     with similar effects, will have similar benefit in this patient population.~   "
196607|NCT00989898|"~     Children and adolescents with type 1 diabetes need regular insulin injections or continuous~     insulin delivery with an insulin pump in order to keep blood sugar levels normal. The~     investigators know that keeping blood sugars in the normal range can prevent long term~     diabetes complications involving the eyes, kidneys and heart. However, achieving treatment~     goals can be very difficult as the tighter the investigators try to control blood glucose~     levels, the greater the risk for the young person to develop symptoms and signs of low~     glucose levels (hypoglycaemia). This is a particular problem at night. One solution is to~     develop a system whereby the amount of insulin injected is very closely matched to the blood~     sugar levels on a continuous basis. In a closed loop system, for example, a continuous~     glucose sensor communicates with a computer algorithm which drives an insulin pump. The~     investigators have been developing such a system in Cambridge over the last year with funding~     from the Juvenile Diabetes Research Foundation. The investigators have found that this system~     is very effective at preventing hypoglycaemia in young people with diabetes.~      Until now the information from the sensor has been entered manually into the computer and the~     pump settings have also been changed manually. The investigators now need to move onto the~     next step which is to fully automate the system. The studies will be done in a clinical~     research facility. The investigators will study the young people on two nights in order to~     find out if the closed loop system started early in the evening is as effective as when it is~     started later before sleep. 12 young people will be recruited from diabetes clinics in the~     East Anglia region. The studies will provide further important information concerning the~     safety, efficacy and utility of closed loop systems.~   "
196608|NCT00989885|"~     The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a~     recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients~     attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The~     data were collected from records, wich are of questionnaires, including the ESE, prepared by~     the CESF professionals and responded, previously, by the own patients. The study compared the~     result obtained in the scale of Epworth with the data of polysomnography. The analysis of~     data was performed using the SPSS, based on descriptive and inferential statistics, being~     used the average considering the standard deviation, and, to the crossing of variables, was~     used the chi-square test of Pearson, considering as significant statistically values of~     p<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.~   "
196609|NCT00989872|"~     This was a randomized, double-blind, placebo-controlled, ascending single dose safety,~     tolerability, and pharmacokinetic study of orally administered EDP-322. This study was~     conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in~     target patient populations.~   "
196610|NCT00989859|"~     The researchers want to determine if ambient light, plethysmographic , can monitor reliably~     heart rate, respiration rate and oxygen saturation in infant patients in a hospital setting.~   "
196611|NCT00989846|"~     Disease related biomarkers have been established decades ago, e.g. blood glucose for diabetes~     diagnosis and management. Their discovery has grown dramatically during the past decade and~     they have the potential to lead the physician in diagnosis -especially differential diagnosis~     - and therapy.~      However, a specific serum-biomarker in lung diseases has not been established. Aim of the~     current study is to to measure lung specific proteins in the serum in patients with various~     lung diseases and to correlate those with disease severity, lung function and other~     laboratory results~   "
196612|NCT00989833|"~     1. The primary objective of this study is:~             -  To evaluate the magnitude of the protective effect of the combination of budesonide~               and formoterol on an as-needed basis compared to the use of terbutaline as-needed~               on exercise induced bronchoconstriction in adults and adolescents with mild~               intermittent asthma~        2. The secondary objectives of this study are:~             -  To evaluate the magnitude of the protective effect of the combination of budesonide~               and formoterol as-needed compared to regular once daily use of budesonide plus~               terbutaline as-needed on exercise induced bronchoconstriction in adults and~               adolescents with mild intermittent asthma~             -  To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and~               regular use of budesonide + terbutaline as-needed as terms of adverse event~   "
196613|NCT00989820|"~     The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in~     the treatment of osteoradionecrosis (late damage after radiotherapy) of the jaw.~   "
196614|NCT00989807|"~     This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to~     its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa~     airway infection who have limited treatment options and are at risk for disease progression.~   "
196615|NCT00989794|"~     This is a single arm, open label multi-center study to determine safety and the performance~     of the treatment of cartilage lesions located on the femoral condyle with GelrinC.~      Patients meeting inclusion/exclusion criteria at screening will be enrolled into the study,~     and will receive treatment implantation into their cartilage lesions.~      Treatment will consist of GelrinC implantations at the symptomatic lesion of femur rated as~     ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate.~      The patients will undergo a rehabilitation program during the follow up period.~   "
196616|NCT00989781|"~     Jeffrey Chang MD is conducting a research study to learn more about the increased male~     hormone levels, otherwise known as androgens, seen in women with polycystic ovary syndrome~     (PCOS). Women with PCOS have ovaries that are comprised of many cysts, or follicles. They~     also have irregular or absent menstrual periods and symptoms of increased male hormones, such~     as facial hair or acne. In each part of the study (except part 4 which is for PCOS women~     only) we will be comparing responses of PCOS women to normal controls~   "
196617|NCT00989768|"~     The objective of this study is to compare the field of effects of the botulinum toxins~     (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such~     as more detailed data on the effectiveness in reduction of wrinkles and duration of action on~     the upper part of the face of both products, trough scales and photographs evaluations.~   "
196618|NCT00989755|"~     The purpose of this study is to evaluate Fax to Quit (F2Q) - a strategy that links state~     quitlines to health care delivery systems. FQ capitalizes upon the healthcare visit as an~     opportunity for intervention, consistent with the finding that approximately 70% of smokers~     visit a primary care physician each year. Successful integration of quitlines into healthcare~     delivery will transform regular healthcare visits into easily implemented, cost-beneficial~     avenues via which smokers all across America will be routinely inducted into effective~     cessation intervention. F2Q will be evaluated as follows:~        1. Does F2Q increase contacts and quality contacts, between the quitline and patients who~          smoke and receive health care at a participating clinic? A quality contact is defined~          as a quitline referral that results in the individual enrolling in the quitline~          counseling services. This aim will be assessed by measuring the rates of quitline~          referrals in 49 clinics before and after F2Q has been implemented.~        2. Are contact rates and enrollment rates of F2Q increased by Enhanced Academic Detailing~          at clinic sites (with enhanced academic detailing comprising ongoing training/technical~          assistance as well as performance feedback)?~        3. What are the features of the Fax to Quit (F2Q) and Fax to Quit plus Enhanced Academic~          Detailing (F2Q + EAD) interventions that key clinic personnel found helpful and easy to~          implement, as well as features that were unhelpful and difficult? This information will~          be gathered in qualitative assessments that also will identify clinic strategies and~          organizational features that facilitated successful implementation.~        4. What are the incremental costs of instating and sustaining F2Q and F2Q + EAD and how do~          these costs compare to other quitline promotional strategies (e.g., paid media,~          medication give-away programs)?~   "
196619|NCT00989742|"~     The purpose of the study is to test if the drug doxycycline is effective in slowing the~     progression of lung disease in LAM. Lymphangioleiomyomatosis (LAM) is a rare lung disease~     which affects young women. Women with LAM develop enlarged air spaces in the lungs called~     cysts, caused by an excess of matrix metalloproteinases (MMPs), protein-digesting enzymes.~     LAM is associated with kidney tumours, called angiomyolipomas, and causes recurrent lung~     collapse, breathlessness and death or need for lung transplant. There is no proven treatment.~     Doxycycline, a commonly used antibiotic can block MMP production and a small number of~     patients have shown some benefit from doxycycline. The investigators will perform a study to~     test if doxycycline can slow the fall in lung function in patients with LAM. Forty patients~     who consent to participate will take doxycycline or a placebo (dummy) tablet for two years in~     addition to their standard treatment.~   "
196620|NCT00989729|"~     The purpose of this study is to attenuate the systemic inflammatory response after~     Endovascular repair of abdominal aortic aneurysms, by administration of a single preoperative~     dosage of Methylprednisolone.~   "
196621|NCT00989716|"~     Nitric oxide is a multimodal candidate treatment for acute stroke having a number of~     properties which may be beneficial in acute stroke, including lowering blood pressure,~     causing cerebral vasodilation, and improving central and systemic haemodynamics. Nitric oxide~     donors are effective in experimental stroke and pilot studies in patients suggest that one,~     glyceryl trinitrate, can be delivered easily in a transdermal preparation. Around half of all~     patients admitted with acute stroke are taking antihypertensive therapy immediately prior to~     their stroke. No data exist as to whether it is beneficial or safe to stop or continue this~     treatment during the acute phase. ENOS is a prospective, international, multicentre,~     randomised, parallel-group, blinded, controlled, collaborative, factorial trial designed to~     test two questions related to the management of blood pressure immediately post-stroke:~        1. The safety and efficacy of nitric oxide, given as transdermal glyceryl trinitrate.~        2. The safety and efficacy of stopping or continuing prior antihypertensive medication.~      Previously independent adult patients who are conscious and have residual limb weakness are~     eligible for enrollment. Central randomisation will be performed via the internet. Treatment~     is initiated within 48 hours of stroke onset and is given as daily glyceryl trinitrate~     patches for 7 days. A computed tomography (CT) scan is required within 7 days of~     randomisation. Early follow-up is performed locally over the 7 days of treatment, including~     blood pressure, early stroke events, and adverse events. Telephone central follow-up by the~     trial co-ordinating centre will be performed at 3 months. The primary outcome is combined~     death or dependency (modified Rankin Score >2).~   "
196622|NCT00989703|"~     The purpose of the study is to evaluate the safety and tolerability of multiple increasing~     oral doses of GLPG0259 compared to placebo.~      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing~     oral doses, and potential drug-drug interaction with single dose methotrexate will be~     assessed.~   "
196623|NCT00989690|"~     RATIONALE: Studying the proteins expressed in samples of blood and tissue from patients with~     cancer may help doctors identify biomarkers related to cancer. It may also help doctors~     predict how patients will respond to treatment.~      PURPOSE: This randomized phase III trial is studying blood and tissue samples in predicting~     response to second-line therapy using erlotinib hydrochloride or chemotherapy in patients~     with advanced non-small cell lung cancer.~   "
196624|NCT00989677|"~     Background of the study:~      Rheumatoid Arthritis (RA) is an autoimmune disease. There are four stages of the disease:~        1. Synovial inflammation~        2. Swelling of synovium~        3. Pannus formation~        4. Advanced bone and cartilage destruction Currently, there is no cure for RA, making the~          disease a chronic condition. RA is more prevalent in elderly and women. With medication~          it is possible to delay the onset of complications. Over the last decade, the treatment~          of RA has changed. Where treatment was palliative until pain medication was ineffective,~          the treatment is now more aggressive with early administration of disease modifying~          drugs (DMARDs).~      The treatment for RA is staged. First, the patient receives generic, low-cost drugs. If this~     treatment becomes ineffective, the treatment is adjusted with different and usually more~     advanced drugs. Biologics are a category drugs that are considered most advanced and most~     expensive.~      For effective treatment, there are two unmet needs.~        -  A tool to aid early diagnosis, as this allows early treatment and delay of complications~          and physical restrictions for patients.~        -  A safe, simple and cheap tool to monitor disease progress to allow traceable,~          operator-independent informed decisions on treatment adjustments.~      Non-invasive optical methods offer several advantages over existing modalities. Optical~     contrast can be related to physiological parameters in the body, such as blood concentration~     and oxygenation. At relevant wavelengths and intensities, optical radiation is completely~     harmless. The cost of optical methods is low compared to other modalities. An important~     application, where optical methods can help diagnosis and treatment is detection of~     inflammation of joints in patients suffering from rheumatoid arthritis (RA). Due to the~     highly scattering nature of tissue, non-invasive optical methods for medical imaging are~     limited to the extremities of the human body. For application in joint diseases, this is~     acceptable, because imaging of hands can provide sufficient clinical information.~      Objective of the study:~      Primary objectives:~      This is a retrospective, nonrandomized controlled observational study, conducted in a single~     center to evaluate the potential of optical attenuation measurements to establish disease~     activity for rheumatoid arthritis patients.~      Secondary objectives:~      Establish parameters from transient optical transmission measurements of the joint that~     relate to clinical evaluation results of individual joints Evaluate relation between disease~     activity (DAS-28 score) and the optical attenuation spectra of the fingers of a patient.~      Study design:~      This is a cross sectional, nonrandomized controlled observational study, conducted in a~     single center to evaluate the potential of optical attenuation measurements to establish~     disease activity for rheumatoid arthritis patients.~      Study population:~      The subject population will be patients visiting the Regionaal Reuma Centrum Eindhoven for~     rheumatoid arthritis. Patient visiting this center will represent a cross section of RA~     patients that are taken care of in an outpatient setting.~      Primary study parameters/outcome of the study:~      Primary endpoint is a successful measurement of optical attenuation of a joint and the part~     of the finger next to the joint before, during and after two consecutive restrictions of~     venous blood flow by means of a pressure cuff.~      Secondary study parameters/outcome of the study (if applicable):~      Secondary endpoints are unsuccessful measurements related to early termination of the~     measurement related to patient discomfort or safety and equipment or software failure.~   "
196625|NCT00989664|"~     The results from Phase 1/2 (RIT-I-000) and Phase 2 (RIT-II-001) studies of Tositumomab and~     Iodine I 131 Tositumomab (TST/I-131 TST) demonstrated that TST/ I-131 TST produced a high~     response rate in patients with chemotherapy-relapsed/refractory, low-grade or transformed~     low-grade Non-Hodgkin's Lymphoma (NHL). On the basis of these results this study was designed~     to compare the efficacy of TST/ I-131 TST to the last qualifying chemotherapy regimen in~     patients with chemotherapy-refractory, low-grade or transformed low-grade NHL.~   "
196626|NCT00989651|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with carboplatin, paclitaxel, and bevacizumab in treating patients with newly diagnosed stage~     II-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer. Veliparib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cells to repair~     themselves from damage and survive. Drugs used in chemotherapy, such as carboplatin and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab, a~     type of drug called a monoclonal antibody, blocks tumor growth by targeting certain cells and~     preventing the growth of new blood vessels that tumors need to grow. Giving veliparib~     together with carboplatin, paclitaxel, and bevacizumab may kill more tumor cells.~   "
196652|NCT00989313|"~     This study is designed to follow up patients, who have participated in the PEP005-028 study~     and observed complete clearance of their Actinic Keratosis (AK) lesions, over a 12 month~     period to assess both recurrence of AK lesions and long term safety in the selected treatment~     area.~   "
196696|NCT00988741|"~     This is a global randomized, placebo-controlled, double-blinded Phase 2 study designed to~     compare treatment of ARQ 197 versus placebo in patients with unresectable HCC who had~     radiographic disease progression after systemic first line therapy or were unable to tolerate~     the therapy.~   "
196627|NCT00989638|"~     The purpose of this study is to develop a coordinated, standardized screening program for the~     early detection of breast cancer in high-risk women. This would include Breast Mammography~     and Magnetic Resonance Imaging (MRI) examination of your breasts. The University of Chicago~     Department of Radiology is performing research to develop better ways of imaging the breast.~     The investigators would like to be able to reliably identify abnormal tissue and determine~     whether abnormal areas contain cancer without surgical procedures (i.e., a biopsy which~     involves removing breast tissue with a needle or surgical instrument). Annual mammography has~     already been recommended for the patient based on family history or personal history of~     cancer. In young women, dense breasts sometimes make it difficult to find abnormal changes on~     breast cancer screening (mammograms). MRI, in combination with mammography, may increase the~     rate of detection of early cancers. In addition, MRI can provide better images of breast~     tissue. The investigators hope to prove that combining multiple screening measures including~     biomarkers improves the chances that, if you have a small cancer or pre-cancer, it will be~     found early. This study will also evaluate quality of life measures during breast cancer~     screening and compare breast MRI and mammogram in a high-risk population. The investigators~     will establish a database of clinical characteristics, blood biomarkers and interventions~     that will be saved for future analysis and aid in the development of more effective screening~     in high-risk women. This research will also help us develop tools for studies in the future.~   "
196628|NCT00989625|"~     This is a pharmacokinetic (PK) study designed to investigate a combination product containing~     sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg~     sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg~     sumatriptan/500mg naproxen sodium) in adolescent migraine patients. The same doses will be~     also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters~     will be compared between these two groups and between doses.~   "
196629|NCT00989612|"~     This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK~     Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged~     20-64 years.~   "
196630|NCT00989599|"~     To verify the efficacy of topical applications of Chamomilla recutita infusion for phlebitis~     treatment, before dose response curve study and pilot study.~   "
196631|NCT00989586|"~     A phase I dose escalation study of veltuzumab and milatuzumab in relapsed and refractory~     B-cell NHL. The phase I study will be followed by a pilot phase II study.~   "
196632|NCT00989573|"~     The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the~     optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8~     weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid~     [5-ASA] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active~     Crohn's disease.~   "
196633|NCT00989560|"~     This randomised, controlled study aims to evaluate the impact of endoscopic assessment, and~     adjustment of therapy, after surgery in patients with Crohn's disease. The primary endpoint~     is the severity of endoscopic recurrence. In addition, tissue will be collected for~     microbiological and immunological analysis.~   "
196634|NCT00989547|"~     Type 1 diabetes (T1D) is still associated with tremendous morbidity and premature mortality.~      Patients require multiple daily insulin injections throughout their lives as well as close~     monitoring of their diet and blood sugar levels to prevent complications. Unfortunately,~     there is presently no permanent cure for diabetes. Whole pancreas or islet cell~     transplantation is available only to a very limited number of patients and necessitates~     potential lifelong immunosuppressive therapy. Autologous stem cell transplants have been used~     successfully for ALL (acute lymphoblastic leukemia), AML (acute myeloblastic leukemia) and~     for the treatment of a variety of cancers including breast cancer and neuroblastomas, and~     more recently for the treatment of autoimmune disorders such as multiple sclerosis (MS),~     lupus-like disease, and rheumatic disorders. Recently it was shown that bone marrow-derived~     stems cells transplanted into diabetic mice led to reduced hyperglycemia within 7 days after~     transplantation and was sustained until they were sacrificed at 35 days post-transplantation.~     The investigators' goal is to transfuse autologous umbilical cord blood into 23 children~     (Germany 10 and 20 Controls) with T1D in an attempt to regenerate pancreatic islet insulin~     producing beta cells and improve blood glucose control. As secondary goals, the investigators~     aim to track the migration of transfused cord blood stem and study the potential changes in~     metabolism/immune function leading to islet regeneration.~   "
196635|NCT00989534|"~     This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk~     of diabetes, independently of the amount of sleep loss.~   "
196636|NCT00989521|"~     PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma.~      Study objectives are to :~        1. to evaluate the safety of PUR003 in subjects with asthma, and~        2. to evaluate the efficacy of PUR003 in assisting the treatment of asthma.~   "
196637|NCT00989508|"~     Open-heart surgery causes injury of the heart muscle. Although this is usually mild,~     temporary and reversible, if it is severe it can endanger life and require additional high~     cost care. During surgery, techniques are used to protect the heart from injury, but these~     remain imperfect. Patients with a thickened wall of the heart (left ventricular hypertrophy)~     may be at greater risk. This study assesses the effect of facilitating sugar metabolism (a~     more efficient fuel) by the heart muscle using the drug Perhexiline given before the~     operation.~      This treatment has a sound experimental basis for improving outcome. If this improvement is~     confirmed surgical results could be improved. The investigators will be studying heart~     function, heart muscle energy stores and chemicals which quantify the amount of heart muscle~     injury. The investigators' hypothesis is that Perhexiline will improve the protection of the~     heart by decreasing damage that may occur during heart surgery.~   "
196638|NCT00989495|"~     The purpose of this study is to gain initial experience and information for proper planning~     and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study~     of bracing).~   "
196697|NCT00988728|"~     The purpose of this study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is~     more effective than placebo in the treatment of patients with schizophrenia, using olanzapine~     15 mg once daily as active control.~   "
196639|NCT00989482|"~     The purpose of this study is to improve antibiotic prescribing practices of Mexican primary~     care physicians for patients seeking care for acute respiratory tract infections (ARIs). The~     investigators will employ a combination of qualitative and quantitative methods to develop~     and evaluate a patient education and physician decision-support intervention.~      Hypothesis 1: The investigators will identify barriers and facilitators of appropriate~     antibiotic use for ARIs that can be addressed through patient education and physician~     decision-support.~      Hypothesis 2: The proportion of patients who report desire for antibiotics as a very~     important reason for seeking care will decrease from 50% to 30% following exposure to the~     educational intervention; and 90% (95% confidence interval: 80% to 100%) of patients will~     report that they trust the information provided by the computer.~      Hypothesis 3: Antibiotic prescribing for adults with uncomplicated acute bronchitis will~     decrease from 80 percent to 40 percent following the introduction of a real-time clinical~     decision support tool.~   "
196640|NCT00989469|"~     A multicentre two-part phase I/II study evaluating response and safety of SORAFENIB in~     combination with irinotecan in the second line treatment or more of metastatic colorectal~     cancer with K-RAS mutation.~   "
196641|NCT00989456|"~     This study addresses self management and maintenance of health through evaluation of a~     program of patient education in combination with physical training and with a structured~     follow-up.~      It is hypothesized that such a program will:~        1. improve quality of life, physical functioning, coping in everyday-life~        2. reduce hospitalization and (re-)admissions for patients with chronic disease, reduce~          consumption of home care services and can increase consumption of general practice and~          physiotherapy services in primary health care.~        3. improve patient satisfaction and health care providers satisfaction~   "
196642|NCT00989443|"~     Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of~     cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the~     standard treatment is the conisation of cervix (surgical act). A local treatment with the~     antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and~     reduce obstetrical morbidity induced by the conisation.~      This clinical study is aimed at :~        1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix~          exhibiting high grade CIN lesions;~        2. evaluating the pharmacokinetic (PK) profile of cidofovir after local application.~   "
196643|NCT00989430|"~     The purpose of this research study with a randomized controlled design is to examine the~     effects of prism adaptation treatment on two visual-spatial recovery components. After a~     stroke, an internal GPS, locating where objects or people lie in a particular area of~     space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body~     aiming movements. The research team wishes to discover whether prism adaptation treatment~     (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects~     visual-spatial where or aiming errors selectively after stroke.~      This research represents one of the first attempts to apply what we know about the brain from~     neuroscience research, to modern clinical rehabilitation practices.~   "
196644|NCT00989417|"~     In many aspects of every-day life, modern communication systems bring about a remarkable~     increase in comfort and safety by transmitting data and information in an easy and reliable~     manner. In order to provide these advantages also to patients with implantable~     cardioverter-defibrillators, as well as to their physicians, BIOTRONIK has developed a~     long-distance implant telemetry to enable periodic trend and event-triggered transmissions of~     implant data and intracardiac electrogram over distances of several meters. The data is~     received by a patient device and subsequently automatically transferred to a BIOTRONIK~     Service Center that provides it to the physician on a password secured internet site. Hence,~     the physician receives diagnostic information without the patient having to visit the~     physician (Home Monitoring, HM). New possibilities will arise for a detailed medical and~     event-correlated supervision of the patient's therapy using electrically active implants.~   "
196645|NCT00989404|"~     The purpose of this study is to compare the safety and tolerability of Zanamivir using a~     Rotahaler device presentation to placebo within the Rotahaler presentation and to the~     Diskhaler device.~   "
196646|NCT00989391|"~     The purpose of this study in heathy people is to investigate the safety, toleration and time~     course of PF-03654764 in the blood, following multiple doses given once or twice daily by~     mouth for 10 days.~   "
196647|NCT00989378|"~     This study will examine the relationship between the amount of slow wave sleep (deep sleep)~     and the ability of the body to bring the blood sugar level to a normal range after receiving~     glucose.~   "
196648|NCT00989365|"~     The investigators hypothesize that aerobic training can reduce anxiety, depression and airway~     inflammation and those benefits may be related to changes in autonomic system.~   "
196649|NCT00989352|"~     The purpose of this study is to determine whether combined chemotherapy [rituximab plus high~     dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with~     procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in~     patients > 65 years.~   "
196650|NCT00989339|"~     Recent evidence suggests that increased levels of a circulation fat (free fatty acids or~     FFAs) can cause high blood pressure and cardiac complications. Intralipid is the only type of~     fat approved by the FDA for clinical use. It is usually used as nutrition support in~     malnourished patients. The investigators' preliminary studies indicate that Intralipid~     results in a significant rise in blood pressure, blood vessel stiffness, and inflammation in~     obese subjects. Olive oil can also be used as nutrition support. The effect of olive oil~     intravenous (IV) on blood pressure and inflammation is not known. In this study, the~     investigators will compare the effect of Intralipid and olive oil on blood pressure, blood~     vessel stiffness and inflammation in healthy subjects. The investigators hypothesize that~     Olive oil emulsions will result in less vascular changes and less inflammatory response than~     Intralipid solutions. Accordingly, the investigators propose a systematic evaluation of the~     effects of Intralipid, olive oil and normal saline on blood pressure, endothelial function~     (vascular stiffness), inflammation in normal subjects.~      A group of obese subjects will be admitted to the Clinical Research Center on 3 occasions.~     Subjects will receive repeated infusions of Intralipid, ClinOleic, and normal saline at 20~     ml/hour for 24 hours.~   "
196651|NCT00989326|"~     The study investigates whether home monitoring follow-up of Pace-Maker patients is as~     efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).~   "
196653|NCT00989300|"~     The purpose of this study is to assess, whether the administration of a proton pump~     inhibitor, Rabeprazole, has a negative effect on the activity of a concomitantly administered~     blood thinner drug. Proton pump inhibitors (PPI's) are prescribed for patients with gastric~     problems to reduce the gastric acid secretion. The blood thinner drug, Clopidogrel,~     administered in this trial is approved for the treatment of mild heart attacks; it works by~     preventing blood platelets from sticking together to form clots that would restrict blood~     flow. Previous trials have shown that the proton pump inhibitor omeprazole interacts with the~     blood thinning drug clopidogrel to reduce the active form of clopidogrel, thereby preventing~     the drug's blood thinning effect. In this trial, the effect of two different proton pump~     inhibitors, namely rabeprazole and omeprazole on the activity of the blood thinner drug~     clopidogrel will be assessed and compared to the effect of placebo on the activity of the~     blood thinner drug clopidogrel. This will be done in three sequential periods and each of the~     patients enrolled into this trial will be asked to participate in three different periods,~     during which clopidogrel with either rabeprazol, or omeprazol, or placebo will be~     administered daily.~   "
196654|NCT00989287|"~     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     investigational vaccine GSK2340272A in adults aged 18 to 60 years.~   "
196655|NCT00989274|"~     In agreement with the World Organization of the Health (WHO), during the annual epidemics of~     influenza they become infected between 10-20 % of the total population, appearing from a~     feverish disease up to leading to the hospitalization and in some cases to the death. To~     unpredictable intervals and due to the nature of the virus, this one can acquire new genes of~     others virus of the influenza that they concern birds or porks, of it it turns out to be a~     new virus with a completely new subtype of IT (HE,SHE) HAS and NA, and if this one is~     transmitted efficiently of person-to-person can cause a pandemic.~      This phenomenon has been the one that has given place to the appearance of a new causative~     virus of the outbreak of influenza humanizes in Mexico (A/México/2009 (H1N1)), and in~     agreement to official Mexican numbers(figures), until August 13 there have been~     brought(reported) a whole of 18,861 cases and 163 deaths. The measure of the most effective~     control against the influenza constitutes it the vaccine, by what study becomes imperative to~     possess (to rely on) a vaccine against the new virus To (H1N1) East is relevant, due to the~     level of response of alert to a level 6 (pandemic) that has passed the World Organization of~     the Health (WHO).~   "
196656|NCT00989261|"~     AC220 will be administered as a once daily oral solution given continuously as 28-day~     treatment cycles, without any rest periods, until disease progression, relapse, intolerance~     to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).~   "
196657|NCT00989248|"~     At the neck level immersion, the water pressure causes significant displacement of blood from~     the lower limbs to the Intrathoracic circulation, triggering adaptive physiological responses~     due to the increase in central blood volume and consequent cardiovascular burdens. Immersion~     in warm water breaks the homeostasis, stimulates regulation mechanisms and responses of~     organs and systems beneficial to healthy and heart failure individuals. In literature there~     are a growing number of studies demonstrating the efficacy of exercises performed in the~     water.~   "
196658|NCT00989235|"~     The purpose of this exploratory sub-study was to evaluate from a clinical perspective the~     impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in~     subjects who had achieved remission (Disease Activity Score 28 [DAS 28]-erythrocyte~     sedimentation rate [ESR] < 2.6) at Day 701 of study IM101023.~   "
196659|NCT00989222|"~     Promising results have been reported after volar locked plating of unstable dorsally~     displaced fractures of the distal radius. It offers stable fixation and early mobilization.~     The investigators' aim is to test if volar locked plating results in better~     patient-perceived, objective functional and radiological outcomes compared to the less~     invasive external fixation that has been the standard operation for decades.~   "
196660|NCT00989209|"~     Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin~     injection in patients with long standing facial unilateral palsy.~   "
196661|NCT00989196|"~     This is a clinical study to investigate the pharmacokinetics, efficacy, safety and~     immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant~     FVIII concentrate in previously treated patients with severe Hemophilia A.~   "
196662|NCT00989183|"~     The goals of this research proposal are to further our understanding of the reproductive~     aging process in women and to improve our ability to clinically assess and model reproductive~     aging. Reproductive aging is a continuous process that begins many years prior to menopause.~     Women in their late 30s and early 40s usually maintain normal menstrual function and~     ovulatory status, yet fertility in these women is considerably compromised compared to~     younger women. The primary mechanism of reproductive aging is through the process of ovarian~     primordial follicle (egg) depletion, a process that exhibits considerable variation between~     women. As a result, the age at which an individual begins to experience infertility and~     menstrual cycle changes secondary to follicle depletion also varies significantly and is~     difficult to predict. Multiple studies have investigated the impact of lifestyle choices~     (tobacco use, oral contraceptives, BMI, alcohol use, and parity) on reproductive lifespan by~     correlating the impact of these exposures with the age of spontaneous menopause. Although~     occasionally in agreement, many of these studies report contradictory findings. Alcohol use~     either delays or has no effect upon the age of spontaneous menopause. Similarly, oral~     contraceptive pill use has been suggested to both accelerate and delay the onset of~     menopause. The most consistent findings regarding the impact of these factors is an~     acceleration in the age of menopause by 1-2 years in smokers. Given the lack of consistent~     findings in these investigations, the exact impact of lifestyle factors on reproductive age~     is currently unknown. Nevertheless, the magnitude of such exposures in the U.S. population is~     considerable, with 19% of adult women using oral contraceptives and 19.2% current smokers~     according to recent statistics. This proposal seeks to develop better models of normal female~     reproductive aging through anatomical studies investigating the impact of lifestyle choices~     on ovarian primordial follicle number. A secondary aim is to determine the relationship~     between newly described markers developed to assess biological aging in other organ systems~     (white blood cell telomere length and the measurement of advanced glycation end products~     (AGEs) through skin autofluorescence) and reproductive age.~   "
196677|NCT00988988|"~     Participants are asked to be in this study because they have multiple sclerosis, are~     currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain,~     swelling, itching or a lump at the injection site.~      The purpose of this study is to determine if the use of ethyl-a-guanida-methyl ethanoate~     (AGEE) will decrease histamine response measured by redness, swelling, and itch response~     following subcutaneous injection of glatiramer acetate (GA) for the treatment of Multiple~     Sclerosis (MS).~   "
196770|NCT00987779|"~     Primary objective for this study is to demonstrate bioequivalence between Japanese commercial~     tablet and Japanese commercial image liquid formulation. Secondary objective for this study~     is to estimate the food effect for Japanese commercial image liquid formulation.~   "
196663|NCT00989170|"~     The long-term goal of this project is to develop, evaluate, and disseminate to Extension~     Service families across the state of Colorado, an engaging, interactive, and evidence-based~     Family Program in order to prevent weight gain in adults and excess weight gain in children.~     Excess weight gain in children is defined as an increase in body weight beyond the increase~     in weight associated with normal growth and development. The program will focus on small,~     easily adopted, sustainable, lifestyle changes.~      Project Objectives include:~        1. Enhancing a Family Program by including food and physical activity environmental~          assessments, an online social network, and a pre-programmed health-based text messaging~          system, and by gaining feedback from extension families through a series of 6 focus~          groups.~        2. Conducting a randomized trial to evaluate the impact of the enhanced Family Program on~          the prevention of weight gain in families with overweight children. The investigators~          hypothesize that excess weight gain will be prevented in subjects in the intervention~          group, while those in the control group will gain excess weight.~        3. Disseminating the Family Program through USDA Cooperative Extension Services in Colorado~          and evaluate the usefulness/effectiveness of the program for USDA Extension agents and~          participating families. The investigators will conduct 4 additional focus groups at the~          end of this objective to gain feedback on its usefulness in a real-life setting. This~          objective is different from objective 2 in that the investigators are evaluating the~          program in a real-life setting, using qualitative and self-reported data, rather than~          conducting a clinical trial.~      By conducting focus groups with Extension families during both objectives #1 and 3, the~     Family Program will help to improve knowledge regarding behavioral and environmental factors~     influencing obesity. After enhancing the Family Program (Objective #1), the investigators~     will test its effectiveness in a randomized study of 200 families (Objective #2). Finally,~     after having developed and tested this effective intervention strategy, the investigators~     will disseminate it through Extension Agents throughout the state to evaluate its usefulness~     in a real-life setting (Objective #3).~   "
196664|NCT00989157|"~     This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine~     between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control~     subjects matched for body mass index (BMI), age and gender.~   "
196665|NCT00989144|"~     The study of early, acute HIV infection is critical to understanding subtype-specific~     pathophysiologic differences, since up to 50% of acute HIV infections may be incapacitating.~     This study will establish whether the patient population of the Thai Red Cross Anonymous~     Clinic is suitable for the study of early, acute infection.~   "
196666|NCT00989131|"~     RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has~     a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor~     EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical®~     does not contain Cremophor EL, hypersensitivity reactions can be expected to be less.~      PURPOSE: To study the efficay and safety of two different formulations of paclitaxel,~     Paclical® and Taxol®.~   "
196667|NCT00989118|"~     This is a randomised study comparing the effect of two laparoscopic techniques for treatment~     of ovarian endometriomas on recurrence rate and ovarian reserve.~   "
196668|NCT00989105|"~     RATIONALE: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by~     single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer~     and learn the extent of disease.~      PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and~     to see how well it works for imaging procedures in patients with prostate cancer.~   "
196669|NCT00989092|"~     This phase 2, multicenter, randomized, open-label, comparative study was designed to~     determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health~     related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not~     receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to~     receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of~     observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).~   "
196670|NCT00989079|"~     Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2~     diabetes mellitus. The primary purpose of this study is to evaluate the safety and~     tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin~     under fed and fasted conditions in healthy volunteers.~   "
196671|NCT00989066|"~     To evaluate the performance and long-term clinical outcomes of the Xience V~     everolimus-eluting coronary stent system (EECSS) in the treatment of minimally selective,~     high risk patients in the real-world clinical practice.~   "
196672|NCT00989053|"~     Women undergoing IVF show a high prevalence of depressive and anxiety symptoms. Furthermore,~     stress has harmful consequences on IVF and pregnancy outcomes. An immunological cascade was~     suggested to be involved in the process. Treatment in this setting is usually psychotherapy~     rather than pharmacotherapy, despite reasonable biological evidence suggesting beneficial~     influence of antidepressant therapy on pregnancy and well-being. Moreover, pharmacotherapy is~     more available and affordable than psychotherapy in the public health system. The~     investigators suggest to study the efficacy of antidepressant treatment in women undergoing~     IVF treatment, presenting with mild mood symptoms. The investigators hypothesize that~     treatment will result in a greater attenuation of affective symptoms, as well as in higher~     pregnancy success rates. Furthermore, certain immunological stress-reactive factors, may~     prove to be the biological mechanism underlying these effects.~   "
196673|NCT00989040|"~     Pain is defined as a sensorial and emotional phenomenon and lead consequences on the~     cognition. These consequences could be increased with usual treatment. So the aim of this~     study is to explore these cognitive consequences.~   "
196674|NCT00989027|"~     The purpose of this study is to compare the ability of a sample of uterine muscle tissue to~     contract in the presence of various drugs. The drugs studied are typically used to contract~     the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic~     drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most~     effective one to use is not known.~      The investigators will be testing uterine muscle samples in the presence of these drugs at~     various concentrations, to see what their contractility measures over time, as compared with~     a control sample, in which no drugs will be applied.~   "
196675|NCT00989014|"~     This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to~     investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel~     (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis~     of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in~     a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%,~     0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once~     daily dosing for one day) of study medication.~   "
196676|NCT00989001|"~     The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in~     subjects with recent onset (AF > 3 hours to <= 7 days), symptomatic atrial fibrillation and~     no evidence or history of congestive heart failure.~   "
196693|NCT00988780|"~     The purpose of this study is to determine if Maraviroc administration can decrease IRIS~     incidence in HIV infected patients initiating ARV therapy.~   "
196678|NCT00988975|"~     Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health~     are eligible to enroll in this study. Two different methods of correcting rectocele at the~     time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and~     patient satisfaction with intercourse and bowel function. One of the surgical methods uses an~     additional graft material and one surgical method does not. It is hypothesized that the~     method which uses an additional graft material to strengthen the patient's tissues will have~     a better outcome.~   "
196679|NCT00988962|"~     Chronic back pain patients are often dismissed from a pain center or a primary care practice~     when they are noncompliant with opioid therapy, instead of being offered treatments to reduce~     misuse and to improve compliance. Unfortunately, there are few treatment resources for such~     patients. This study seeks to remedy that problem, with the goal of reducing the rate of~     prescription opioid misuse among noncompliant patients through the use of novel tracking,~     education, and counseling interventions.~   "
196680|NCT00988949|"~     This study will be a Proof of Mechanism (POM) study to establish evidence of central~     pharmacodynamic activity for PF 04455242, and will be a parallel group, randomized, double~     blind, sponsor open study conducted in healthy male subjects. Once subjects achieve steady~     state of PF 04455242, they will undergo PF 00345768 (spiradoline) challenge. Data will be~     analyzed to determine whether PF-04455242 blocks spiradoline induced prolactin release.~   "
196681|NCT00988936|"~     A Pilot Phase II Study~      The primary objective for this study is:~        -  To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response~          to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full~          course of treatment is completed~      The secondary objectives for this study are:~        -  To continue safety evaluation by collection of safety data from all patients~        -  To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and~          conduct of future studies~      Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy~     study~      Duration: Screening visit (3-4 hrs), pre-treatment imaging visit of [F-18]RGD-K5 PET/CT (~~     3-4 hrs) and the standard [F-18]FDG PET/CT (~ 3-4 hrs) or diagnostic CT, followed by two~     [F-18]RGD-K5 PET/CT scans, one after the second but before the third Avastin® treatment, and~     one after the fourth but before the fifth Avastin® treatment, and a follow up standard~     [F-18]FDG PET (~ 3-4 hrs) or diagnostic CT.~      Procedures: Informed consent, collection of demographic information, medical history, blood~     labs, physical examination, vital signs, ECGs, three sets of [F-18]RGD-K5 dosing and imaging~     scans including pretreatment, early mid-treatment, and later mid-treatment, concomitant~     medication collection, adverse event monitoring, and assessment of tumor response to~     treatment~      Patients: Approximately forty (40) patients with non-squamous non-small cell lung cancer,~     metastatic breast cancer, metastatic colon or rectum cancer who will receive chemotherapy~     plus Avastin®. This allows for approximately 30 evaluable patients to complete this study at~     approximately four to eight sites internationally~   "
196682|NCT00988923|"~     The purpose of this study is to verify the short-term effects of hyperthermia (HT) in pain~     relief and in functional impairment in patients affected by mild to moderate idiopathic~     carpal tunnel syndrome.~      A single blind randomized sham-controlled trial was performed. A 23 patients were affected by~     idiopathic CTS, 11 of them were affected by bilateral CTS.~      the intervention consists of Hyperthermia device treatment, treated for 20 minutes per~     session, a total of 8 sessions. Primary outcome is pain (Visual analogic scale).~   "
196683|NCT00988910|"~     The purpose of this study is to evaluate the symptoms and satisfaction for women taking~     drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking~     other kind of combined oral contraceptives.~   "
196684|NCT00988897|"~     Primary Objective:~        -  To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6)~          will provide a clinical disease control rate (DCR) of at least 20% at the end of the~          chemotherapy.~      Secondary Objective:~        -  To evaluate other measures of tumour's responses and safety.~   "
196685|NCT00988884|"~     This study will evaluate the tolerability and immunogenicity of administration of the first~     dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one~     month prior to administration of Menactra™ and Adacel™.~   "
196686|NCT00988871|"~     Background: Central venous pressure (CVP) monitoring from the peripherally inserted central~     venous catheter (PICC) has not often been used because of the higher inherent resistance of~     the PICC due to its longer length and narrower lumen. The objective of this study was to~     assess the reliability of the CVP measured from PICCs as a predictor of the CVP measured from~     CICCs in the setting of rapidly fluctuating hemodynamic conditions during liver~     transplantation.~   "
196687|NCT00988858|"~     The primary purpose of this study is to evaluate the efficacy and safety of LY2603618 in~     combination with pemetrexed and any side effects that might be associated with it along with~     determining the effects of LY2603618 in combination with pemetrexed in participants with~     advanced or metastatic Non-small Cell Lung Cancer (NSCLC).~   "
196688|NCT00988845|"~     This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen~     profile in women across a range of body mass index.~   "
196689|NCT00988832|"~     The aim of this study is to quantify how infliximab therapy is being used in the UK and the~     consequent impact on health care resources, which will help to inform budget holders and~     payers on the costs associated with the treatment of Crohn's Disease.~   "
196690|NCT00988819|"~     The overall objective of this study is to investigate in depth the nature of metabolic~     physiology, body composition and epigenetic differences of the different phenotypes of~     overweight and obese individuals who are otherwise overtly healthy among the three major~     ethnic groups in Singapore.~   "
196691|NCT00988806|"~     The purpose of this study is to determine whether the treatment strategy of long-term~     intermittent every 30 days, continuous intravenous infusion for 24 hours of Levosimendan,~     associated to optimal contemporary treatment for advanced heart failure reduce the incidence~     of admission for heart failure worsening at 12 months follow up, compared with the strategy~     based solely in the optimal contemporary treatment for advanced heart failure.~   "
196692|NCT00988793|"~     The study will randomized patients to either open or laparoscopic pancreatic surgery. The~     primary purpose of the study is to determine whether laparoscopic distal pancreatectomy is~     associated with improved outcomes compared to open distal pancreatectomy.~   "
196698|NCT00988715|"~     This phase I trial studies pretargeted radioimmunotherapy and donor peripheral blood stem~     cell transplant employing fludarabine phosphate and total-body irradiation (TBI) to treat~     patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or~     myelodysplastic syndrome. Giving chemotherapy drugs, such as fludarabine phosphate, and TBI~     before a donor peripheral blood stem cell transplant helps stop the patient's immune system~     from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies can be combined~     with fludarabine phosphate and TBI to find cancer cells and kill them without harming normal~     cells. Pretargeted radioimmunotherapy (PRIT) allows for further improved targeting of tumor~     cells over standard directly labeled antibodies.~   "
196699|NCT00988702|"~     The present study aimed to utilize these well-known neuroelectrophysiological techniques to~     investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique.~   "
196700|NCT00988689|"~     The investigators hypothesize that different types of starch vary in their effects on~     appetite, blood sugar and food intake. In this study, subjects consumed five soups containing~     50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added~     starch at one week intervals. The investigators measured food intake at 120 minutes, appetite~     and blood sugar.~   "
196701|NCT00988676|"~     High quality bowel cleaning preparation was most important prerequisites of a accurate~     colonoscopy, because even a small amount of residual fecal matter can obscure small polyps~     and increase unnecessary procedure time. Until now, several studies evaluated the impact of~     bowel preparation on the quality of colonoscopy using comparison of the polyp detection rate~     in patients with adequate bowel preparation status to that in patients with inadequate bowel~     preparation status during colonoscopy. However, there was no direct measurement the effect~     bowel preparation status on the polyp missing rate, the quality of colonoscopy, using tandem~     colonoscopic evaluation in prospective setting.~   "
196702|NCT00988663|"~     The purpose of this study is to determine whether memantine will enhance the therapeutic of~     effect on depression and prevent memory and other cognitive problems caused by ECT.~   "
196703|NCT00988650|"~     While there is now undisputable evidence relating elevated plasma low-density lipoprotein~     (LDL) cholesterol levels to an increased risk of coronary heart disease (CHD), it is being~     increasingly recognized that a significant proportion of CHD events occur in individuals~     characterized by a cluster of additional metabolic and physiological perturbations now~     defined as the metabolic syndrome. Epidemiological and clinical evidence have shown us that~     nutritional factors, often in conjunction with obesity, play a pivotal role in the~     pathophysiology of the metabolic syndrome. In that regard, accumulating evidence suggest that~     a Mediterranean-style diet (MedDiet) may beneficially modify several components of the~     metabolic syndrome including plasma triglycerides (TG) and high-density lipoprotein (HDL)~     cholesterol levels, insulin resistance, waist circumference and markers of vascular~     inflammation. However, the physiological mechanisms underlying the cardioprotective effects~     of the MedDiet on features of the metabolic syndrome and the importance of body weight~     reduction in maximizing these effects represent key issues that have yet to be investigated.~      The general objective of the study is to investigate for the first time in a controlled~     feeding study the mechanisms and factors underlying the impact of the MedDiet, with and~     without weight loss on the dyslipidemic features of the metabolic syndrome.~   "
196704|NCT00988637|"~     This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate)~     Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one~     of two different regimens:~        1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray~          treatment twice daily on weekends (Sat - Sun) for 28 days~        2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days~   "
196705|NCT00988624|"~     This study will evaluate four different modified release formulation to estimate the amount~     of dimebon available to the body relative to the current dimebon formulation that is given~     three times a day. The results of this study will help inform and guide further formulation~     development efforts with the ultimate goal of reducing dose frequency to once-a-day or~     twice-a-day.~   "
196706|NCT00988611|"~     The goals of this research proposal are to further our understanding of the reproductive~     aging process in women and to improve our ability to clinically assess and model reproductive~     aging. Reproductive aging is a continuous process that begins many years prior to menopause.~     Women in their late 30s and early 40s usually maintain normal menstrual function and~     ovulatory status, yet fertility in these women is considerably compromised compared to~     younger women. The primary mechanism of reproductive aging is through the process of ovarian~     primordial follicle (egg) depletion, a process that exhibits considerable variation between~     women. As a result, the age at which an individual begins to experience infertility and~     menstrual cycle changes secondary to follicle depletion also varies significantly and is~     difficult to predict. The clinical assessment of the number of primordial follicles remaining~     in the ovary has traditionally relied upon the measurement of ovarian or pituitary hormones~     such as FSH, estradiol, and inhibin B. Unfortunately, these measures are all indirect and~     poorly sensitive in the assessment of ovarian reserve. More recently, serum levels of~     anti-Müllerian hormone (AMH) and the ovarian antral follicle count have been utilized as~     clinical measures of ovarian reserve. Both have been correlated with chronological age and~     have some predictive power in determining stimulation quantity (the number of oocytes~     obtained at the time of egg-recovery) in in-vitro fertilization (IVF) treatment cycles.~     Reproductive aging in women; however, is more than just the depletion of oocytes from a~     woman's ovaries, but also involves a decline in oocyte quality. The predictive value of these~     clinical markers of ovarian reserve with regards to oocyte quality is unknown. Additionally,~     new tools developed to assess biological aging in other organ systems such as white blood~     cell telomere length and the measurement of advanced glycation end products (AGEs) through~     skin autofluorescence have not been evaluated with respect to the reproductive aging process.~     This proposal seeks to develop better models of normal female reproductive aging by~     identifying novel markers of ovarian reserve and determining their relationship with both~     oocyte quantity and quality obtained during IVF treatment cycles.~   "
196707|NCT00988598|"~     The purpose of the study is to evaluate the safety of PF-04447943 when given in combination~     with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the~     absorption and distribution of both PF-04447943 and donepezil.~   "
196708|NCT00988585|"~     The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont~     wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such~     a dietary supplement on the market. The goal of this study is to test this oil at doses of~     600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing~     600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will~     be randomized to one of four groups (30 in each group) and studied in both the fasting and~     post-prandial state.~   "
196803|NCT00987350|"~     This research study involves testing of a device that can give injections (shots) without the~     use of a needle.~   "
196709|NCT00988572|"~     Dizziness has been identified as a risk factor for fall and vestibular asymmetry has been~     found among patients with fall-related wrist fractures as well as among patients with~     hip-fracture. Since wrist fracture is a risk factor for hip-fracture, much effort is focused~     on preventing falls for risk-groups. Therefore, it would be interesting to find out if it is~     possible to influence vestibular asymmetry with vestibular rehabilitation.~      The aim of this study is therefore to find out if vestibular rehabilitation can have any~     effect on vestibular function among patients with fall-related wrist fracture.~   "
196710|NCT00988559|"~     This study will test the efficacy and safety of different routes of administration of a DNA~     vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment~     groups. Subjects enrolled in the first two groups will receive vaccination intradermally with~     a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination~     intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.~   "
196711|NCT00988546|"~     The purpose of this study is to compare C&P examination reports performed using a~     Compensation and Pension Examination Program (CPEP) computerized, templated documentation~     tool to a customary examination performed and then report dictated in quality, completeness,~     timeliness and veteran satisfaction.~   "
196712|NCT00988533|"~     The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a~     pediatric population aged 6 months to 3 years.~   "
196713|NCT00988520|"~     The purpose of this study is to compare the infusion rate of Org 9426 following intubating~     dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients.~   "
196714|NCT00988507|"~     Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with~     no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated~     with artesunate - for a 3-day treatment.~      Secondary objectives:~        -  To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment.~        -  To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine~          associated with artesunate and one dose level of ferroquine alone.~        -  To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse~          sampling schedules.~   "
196715|NCT00988494|"~     Safety and efficacy of DE-105 ophthalmic solution in patients with persistent corneal~     epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well.~   "
196716|NCT00988481|"~     The goal of this study is to generate pilot data exploring the addition of an augmentation~     (additional) medication to patients suffering from bulimia nervosa who have responded but not~     had complete symptom resolution with a course of standard medication treatment.~   "
196717|NCT00988468|"~     Earlier research has shown that exercising while receiving manual therapy improves function~     and reduces pain in people with knee osteoarthritis. However, very little is known about the~     mechanisms by which manual therapy and exercise reduce pain and improve function. This study~     will ask subjects with knee osteoarthritis to receive one of the following interventions: (1)~     no treatment, (2) exercise only, or (3) manual therapy only. Measures will be taken of the~     patient's knee range of motion, knee swelling and pain before and after receiving the~     intervention. These measures will be analyzed to determine what effect exercise and manual~     therapy applied to the knee have on improving knee range of motion and reducing knee pain and~     swelling. Swelling will be measured using an ultrasound device which is used to take pictures~     inside the knee. This type of ultrasound measurement is painless and harmless.~   "
196718|NCT00988455|"~     The purpose of this study is to evaluate the efficacy of photodynamic therapy (PDT)in~     treatment of Basal cell carcinoma (BCC) and recurrence rate after 6 months.~   "
196719|NCT00988442|"~     This study tested a system of nursing telephone support to determine if it improves adherence~     to antiretroviral therapy (ART) in at-risk, treatment-experienced people.~   "
196720|NCT00988429|"~     The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093) is an~     effective adjunct therapy in the treatment of refractory partial seizures~   "
196721|NCT00988416|"~     The purpose of the study is to prove the hypothesis that pancreas PET-CT can differentiate~     duct involved IPMN with malignancy from duct involved non-malignant IPMN.~   "
196722|NCT00988403|"~     Fructan is a carbohydrate polymer that is composed of fructose and a terminal glucose moiety~     . Fructans are naturally found in artichokes (6.1 grams/serving), leeks (5.9 grams/serving),~     onion bulbs (1.01 grams/serving), flour (4.0 grams/serving), garlic (.52 grams/serving),~     watermelon (.92 grams/serving), nectarines (.27 grams/serving) and white peaches (.50~     grams/serving). Because fructans are present in many common foods, people typically ingest~     high levels of fructan. The most common structural forms of fructan are inulin, levanare and~     geraminan . The human body absorbs only 5% of fructan, however it is estimated that the daily~     intake in the USA may vary between 1-20 grams, and possibly higher due to the recently~     discovered benefits of inulins . Dietary trends indicate that high levels of fructans are~     common in the European and American diet, as more wheat based products such as breakfast~     cereal, pasta, and bread are consumed.~      Fructans may not be well tolerated by some subjects and its malabsorption may result in~     gastrointestinal (GI) symptoms such as heartburn, belching, abdominal pain, diarrhea, gas,~     and bloating; and this is especially true when higher doses are ingested. Unlike glucose,~     fructans are not efficiently digested or absorbed by the small intestine. The mechanism for~     malabsorption is related to the inability to hydrolyze glycosidic linkages in the complex~     polysaccharide, resulting in the delivery of malabsorbed fructans to the large bowel1. In the~     colon, the malabsorbed fructans are rapidly fermented, and byproducts of this fermentation~     include H2, CH4, and other gases that may contribute to bowel symptoms. Furthermore, the~     small molecular nature of fructans results in an osmotic effect which draws more water into~     the small intestine and causes bloating and diarrhea.~      Ingestion of high doses of fructans can cause symptoms in healthy adults, but may cause more~     bothersome symptoms in subjects with Irritable Bowel Syndrome (IBS). Earlier studies have~     identified that IBS affects between 10 and 15% of the population in the United States.~     Ingestion of 10-20 grams of fructan daily may cause symptoms of IBS, and restricting fructan~     intake in a diet may reduce symptoms in a variety of gastrointestinal disorders. One study~     recently published found that dietary restriction of fructan and fructose was responsible for~     symptomatic improvement in patients with IBS.~      Hypothesis:~      The investigators hypothesize that healthy individuals will absorb fructan 7.5 gram and 10~     gram doses, and will experience malabsorption at the 12.5 gram fructan dose.~   "
196744|NCT00988117|"~     This is an open-label study to investigate the effects of the rivastigmine patch on attention~     and behavior in Parkinson's disease when associated with memory and/or thinking problems.~     Rivastigmine (also sold under the name Exelon) is an FDA approved medication used for the~     treatment of mild to moderate Alzheimer's Disease (AD) and memory or thinking problems due to~     Parkinson's disease. Recently a rivastigmine patch was developed, which has shown similar~     effectiveness with fewer side effects and increased caregiver preference when compared to~     capsules. This is an open-label 12 week study where 15 subjects diagnosed with Parkinson's~     Disease who have mild to moderate memory and/or thinking complaints will be treated with the~     rivastigmine patch at UCSF. This study also analyzes the mechanism by which the rivastigmine~     patch works in people with Parkinson's disease and memory and/or thinking problems.~   "
196723|NCT00988390|"~     -  Context: Mothers living with HIV (MLH) and their children face predictable challenges:~          maintaining physical and mental health, parenting while ill, and addressing HIV-related~          stressors.~        -  Objective: To evaluate the efficacy of a family-based intervention over time; to~          contrast the life adjustments of HIV-affected families and their non-HIV-affected~          neighbors in the current treatment era.~        -  Design: Randomized controlled trial of MLH and a longitudinal comparison of MLH to a~          neighborhood cohort using random effect regression.~        -  Participants and Intervention: MLH (n = 339) and their school-age children (n = 259)~          were randomly assigned to receive 1) an intervention of 16 sessions in a~          cognitive-behavioral, small-group format; or 2) control. MLH and their children were~          compared to non-HIV-affected families recruited at shopping markets. Participant~          retention was high: 84% at 6 months, 83% at 12 months, and 78% at 18 months.~        -  Main Outcome Measures: Family functioning and conflict, mental and physical health,~          sexual behavior, and substance use.~   "
196724|NCT00988377|"~     The objective of this study was to describe relationships among whey protein when consumed~     before a meal on food intake and pre- and post-meal satiety, blood glucose in healthy young~     adults.~   "
196725|NCT00988364|"~     The purpose of this study is:~        -  To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.~        -  To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting~          factor and reduce L5 in Metabolic Syndrome patients.~   "
196726|NCT00988351|"~     The purpose of this randomized prospective study is to compare the efficacy of two approaches~     to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having~     obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway~     involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended~     sleep study) followed by CPAP treatment. The other pathway involves treatment with~     auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP~     adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time~     (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep~     Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two~     study arms.~   "
196727|NCT00988338|"~     The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle~     fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The~     hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical~     outcomes similar to those obtained from autograft and other routinely used allograft~     materials; these include: fusion, improvement in pain, improvement in function, and absence~     of adverse events related to the use of the graft source.~   "
196728|NCT00988325|"~     This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir~     [Tamiflu] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours~     prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will~     receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10~     doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued~     study treatment for an additional 10 doses (5 days). The anticipated time on study treatment~     is 4 weeks, and the target sample size is 65-85 male and female infants.~   "
196729|NCT00988312|"~     Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune~     cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions~     every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in~     order to slow down or cure the disease.~   "
196730|NCT00988299|"~     In older, normal-weight women (60-75 yrs, BMI=18-28 kg/m2), an acute bout of higher-intensity~     (60% of maximum effort) aerobic exercise, in comparison to an isocaloric bout of~     lower-intensity (45% of maximum effort) exercise (caloric expenditure of 3.5 kcal/kg body~     weight for both), will result in differential:~        1. decline in non-exercise activity calorie expenditure in the subsequent 48 hours after~          exercise;~        2. increase in resting metabolic rate 48 hours after exercise;~        3. increase in serum free triiodo-L-thyronine (free T3) concentrations immediately~          following exercise;~        4. decline from pre-exercise in plasma leptin and serum free T3 concentrations 48 hours~          after exercise.~   "
196731|NCT00988286|"~     Biofeedback therapy improves bowel symptoms and anorectal function in patients with~     dyssynergic defecation, however its mechanism of action is not known. The investigators~     hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering~     cortical processing of information and improving cortically mediated neuromuscular function~     of the gut. The investigators' specific aims are; (1) To evaluate the afferent cortical~     evoked potentials in response to the electrical stimulation of the anorectum (i) before and~     after biofeedback therapy and (ii) compare responders with nonresponders. (2) To evaluate the~     corticofugal tracts (efferent) by recording the anal and rectal electromyographic responses~     following noninvasive lumbosacral and transcranial magnetic stimulation (i) before and after~     biofeedback therapy and (ii) compare responders with nonresponders.~      The investigators hypothesize that biofeedback therapy enhances gut-brain-gut communication~     and alters cortical and neuromuscular function. The investigators' specific aims are to~     evaluate 60 patients with dyssynergia (i) before and after biofeedback therapy and (ii)~     compare responders with nonresponders by examining:~      (A) The afferent cortical evoked potentials using electrical stimulation of the anus and~     rectum.~      (B) The efferent cortical evoked potentials by lumbosacral and transcranial magnetic~     stimulation and recording the anal and rectal electromyographic responses.~   "
196745|NCT00988104|"~     The purpose of this study is to determine whether a newly developed, brief cognitive~     behavioral intervention, relative to supportive counseling, is effective in reducing acute~     stress disorder (ASD) and preventing post traumatic stress disorder (PTSD) and depression.~   "
196746|NCT00988091|"~     Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of~     either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety~     for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium~     hyaluronate and be followed for another 26 weeks.~   "
196804|NCT00987337|"~     The primary objective for this study is to determine if the addition of filibuvir to a~     standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the~     proportion of subjects who achieve a sustained viral response (SVR) compared to~     peginterferon/ribavirin (pegIFN/RBV) therapy alone.~   "
196732|NCT00988273|"~     The main objective of this study is to determine the role of epithelial cell homeostasis in~     the pathogenesis of intestinal diseases.~      Background: Alterations in intestinal barrier function may play a significant role in the~     pathogenesis of chronic intestinal diseases such as inflammatory bowel disease (IBD). The~     intestinal epithelium functions as a barrier to the luminal contents, thereby preventing~     undesirable solutes, micro-organisms and other luminal antigens from entering the body.~     Confocal endomicroscopy has recently been shown that increased epithelial cell shedding may~     contribute to increased intestinal permeability, at least locally. In our study, we want to~     determine the contribution of epithelial cell shedding to intestinal permeability in vivo in~     patients with inflammatory bowel disease compared to controls.~      Scope:~      In inflammatory bowel disease patients and controls (patients undergoing endoscopy for other~     indications).~      Methods:~      We will perform confocal endoscopy during the patient's endoscopic procedure.~      Procedure:~      The patient will receive intravenous fluorescein, followed by confocal imaging of the~     gastrointestinal tissue. The images are captured on the computer. The proposed study will~     provide important insights into epithelial cell shedding as a contributor to altered~     intestinal permeability.~   "
196733|NCT00988260|"~     The purpose of this study is to find the optimal dose of Org 37462 for Japanese females~     undergoing controlled ovarian stimulation for in vitro fertilization intracytoplasmic sperm~     injection (IVF-ICSI).~   "
196734|NCT00988247|"~     Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone~     dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol.~     The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA~     is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be~     safe and effective as a dry nasal aerosol which may be preferred by some patients.~   "
196735|NCT00988234|"~     In the present study, the investigators will test the effect of two position on posterior~     lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block.~   "
196736|NCT00988221|"~     This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active~     polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or~     were intolerant of methotrexate. In Part I of the study, all patients received intravenous~     (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients~     < 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate~     response in Part I were randomized to receive either tocilizumab at the same dose as in Part~     I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received~     tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard~     of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID),~     corticosteroids, or methotrexate was continued throughout the study.~   "
196737|NCT00988208|"~     The purpose of the study is to determine whether lenalidomide is safe and effective for use~     in combination with docetaxel and prednisone for the treatment of subjects with metastatic~     Castrate-Resistant Prostate Cancer.~      The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life~     expectancy of these subjects.~   "
196738|NCT00988195|"~     The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is~     safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).~   "
196739|NCT00988182|"~     The purpose of this study is to describe relationships among whey protein and its hydrolysate~     when consumed before a meal on pre- and post-fixed meal satiety, blood glucose and insulin in~     healthy young adults.~   "
196740|NCT00988169|"~     Advanced stage lung cancer is generally treated with anti-cancer medication called~     chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers~     develop in people who never smoked or who only smoked for a short period of time. This type~     of lung cancer may respond to a medication called erlotinib (Tarceva). Erlotinib is an~     anticancer pill that is approved by the Food and Drug Administration (FDA) for use in~     patients with advanced lung cancer. Unfortunately, erlotinib does not work for all patients~     or only works for a period of time. The doctors are trying to find ways to improve the effect~     of erlotinib by combining it with another anti-cancer medication.~      Ascenta Therapeutics, Inc. has developed a drug called AT-101 as a potential treatment for~     cancer. AT-101 is an investigational drug. That means that AT-101 is not approved by the~     United States Food and Drug Administration (FDA) for general use. The FDA does permit its use~     in studies like this one to determine whether it is safe and effective.~      This is the first study to examine the effects of AT-101 and erlotinib. It is hoped that by~     combining AT-101 with erlotinib, AT-101 may help erlotinib work better to shrink lung cancer.~     Studies that have been performed in the laboratory suggest that AT-101 in combination with~     erlotinib may be more effective at shrinking tumors than erlotinib alone.~   "
196741|NCT00988156|"~     The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate~     (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial~     seizures whose condition has not been controlled by other drug treatments.~   "
196742|NCT00988143|"~     The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent~     Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the~     2008-2009 TIV among children and adults.~      Primary Objective:~      To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared~     with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults.~      Observational Objectives:~        -  To describe the safety of the 2009-2010 TIV among subjects ≥6 months to <5 years, 18-60~          years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype~          QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.~        -  To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to~          <5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of~          2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of~          age.~   "
196743|NCT00988130|"~     RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to~     kill tumor cells.~      PURPOSE: This phase II trial is studying the side effects of high-intensity focused~     ultrasound focal ablation and to see how well it works in treating patients with progressive~     prostate cancer.~   "
196747|NCT00988078|"~     The polycystic ovary syndrome is the most common endocrinopathy in reproductive age women.~     The pathophysiology of this syndrome remains unclear, but there are evidences that a~     decreased in insulin sensitivity may be related in this syndrome. There are studies that~     showed the action of factors on the sensitivity of the insulin receptor, such as melatonin.~     It is a hormone produced by the pineal gland, whose role is still uncertain in human~     reproduction, although many studies have found that it may relate sex hormone effect. Many~     patients with polycystic ovary syndrome (PCOS) may have hyperinsulinemia, and that~     pinealectomized rats determined hypoglycemia and hyperinsulinemia, with reduced release of~     insulin in response to glucose. Therefore, it is supposed that blood levels of melatonin~     might correlate with the blood insulin concentration in patients with the syndrome. Moreover,~     the insulin sensitizing agents have been used in the treatment of patients with insulin~     resistance and PCOS, based on its main pathophysiological substrate which is the~     hyperinsulinemia. In fact, the metformin is the most used in the literature. However, there~     are few studies on the use of metformin in adolescents. The evidences of this drugs in this~     group of patients have showed good therapeutic response with few side effects. The objective~     of the study is to evaluate the effects of metformin on insulin resistance and levels of~     melatonin in adolescents with PCOS. It will be performed a prospective, randomized,~     double-blind and placebo-controlled study with 90 adolescents with PCOS. It will be evaluated~     clinical and laboratory parameters (TSH, free T4, prolactin, FSH, LH, estradiol, total~     testosterone, androstenedione, DHEA-s, 17-OH progesterone, SHBG, free androgen index, index~     of HOMA-IR and QUICKI from fasting glucose and insulin, total cholesterol and fractions,~     triglycerides, creatinine, AST and ALT and creatinkinase, fibrinogen and PAI-1, and melatonin~     for 6 months of treatment.~   "
196748|NCT00988065|"~     This trial was conducted to study the potential for hypersensitivity symptoms at the time of~     initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the~     frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a~     prolonged period.~      In total 450 participants (all healthy subjects) were to be randomized to receive one of~     three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16~     mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36,~     and Day 78 of the study in order to determine the safety of each treatment dose.~   "
196749|NCT00988052|"~     The purpose of this study is to make laquinimod 0.6 mg available for all subjects who~     completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate~     the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6~     mg in subjects with relapsing multiple sclerosis.~   "
196750|NCT00988039|"~     The trial aim is to ascertain what, if anything, needs to be combined with a boosted protease~     inhibitor (bPI) backbone in second-line therapy in order to maximize the chance of a good~     clinical outcome following WHO-defined failure on a first-line nucleoside reverse~     transcriptase inhibitor (NRTI) and NNRTI-containing regimen with probable extensive NRTI and~     NNRTI resistance mutations.~   "
196751|NCT00988026|"~     This is a clinical trial to compare the benefits and possible adverse events of two~     antibiotic treatments for mild to moderate acne. It is expected that minocycline~     microgranules will be more effective than lymecycline with a better adverse events profile.~   "
196752|NCT00988013|"~     This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in~     addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for~     advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high grade~     non Hodgkin's or Hodgkin's lymphoma, chronic myelogenous leukemia, and plasma cell leukemia.~     Because the subjects participating in this study have a disease that is severe and has a high~     risk of relapse even after transplant, the investigators propose to use a chemotherapy~     regimen (fludarabine/busulfan), the name for the combination of chemotherapy drugs that is~     given to patients prior to transplantation of the donor stem cells, along with intensity~     modulated radiation (IM-TMI) to the bone marrow. Total body irradiation (TBI) in conjunction~     with chemotherapy is a standard of care as a pre-conditioning regimen prior to bone marrow~     transplant (BMT) in patients with hematologic malignancies. However, TBI can cause severe~     side effects due to irradiation of organs such as the lenses of the eye, whole brain, lungs,~     liver, kidneys, heart, small bowel and oral cavity. IM-TMI allows for the delivery of~     adequate doses of radiation to the bone marrow while sparing other organs and therefore~     limiting radiation side effects. The irradiation, along with receiving the chemotherapy drugs~     will suppress the subject's immune system and kill off tumor cells, but will also intensify~     the effect of the conditioning regimen thus allowing the bone marrow transplantation to have~     a greater chance of being successful.~      No investigational drugs are used in this study. The investigational part of this study is~     the use of intensity modulated total marrow irradiation instead of conventional radiation.~     IMTMI can deliver 99% of the prescribed treatment to the targeted bones and reduce the doses~     of radiation to surrounding organs, as received in conventional TBI, by 29% to 65%.~   "
196753|NCT00988000|"~     Consultations with patients by hospital consultants are organised today in a manner which is~     barely dissimilar from that offered 30 or 40 years ago. Whilst some attempts to improve this~     process, such as Choose and Book, shorter waiting times and patients' receiving a copy of the~     correspondence sent to their general practitioner (GP) have improved the situation, there has~     been little radical change and little thought given to the patient experience.~      The investigators wish to investigate whether patients' experience of attending respiratory~     outpatient clinics can be improved by a pre-clinic telephone call with a specialist thereby~     reducing the number of attendances at the hospital for appointments and investigations and~     improving overall patient satisfaction.~   "
196754|NCT00987987|"~     The investigators have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells~     (Treg) enhances the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after~     allogeneic hematopoietic stem cell transplantation (HSCT) in mice. The investigators thus~     propose a clinical trial to test whether Treg-depleted donor lymphocytes infusion (dDLI)~     could induce an improved graft-versus-tumor (GVT) effect in patients refractory to standard~     DLI (stdDLI) for treatment of relapse after HSCT.~   "
196755|NCT00987974|"~     Rationale:~      Apart from their cholesterol lowering effects, statins have cholesterol‐independent~     pleiotropic actions, such as upregulation of 5'‐ectonucleotidase and up‐regulation of~     NO‐synthase that may increase tolerance against ischemia‐reperfusion injury (IR‐injury).~     Several animal studies have shown reduction of IR‐injury as a result of statin treatment in~     both the heart and the kidney. Recently the investigators have shown, using Annexin A5~     targeting after voluntary ischemic exercise to assess IR‐injury, a protective effect of a 7~     day oral rosuvastatin treatment. A three day treatment with atorvastatin however failed to~     reduce annexin targeting.~      Assessment of the flow mediated dilation of the brachial artery as measure of endothelial~     (dys)function, is a validated model to research effects of possible protective strategies and~     perform mechanistic experiments on IR‐injury in humans in vivo.~      The investigators hypothesize that pretreatment with statins can increase endothelial~     tolerance against ischemia and reperfusion injury.~      Objective:~      To study the protective effect of pretreatment (both 3 day and 7 day) with rosuvastatin and~     atorvastatin on flow mediated dilation after 15 minutes ischemia and 15 minutes reperfusion.~      Study design: placebo‐controlled randomised double‐blind trial~      Study population: Healthy volunteers, age 18‐50~      Intervention: Treatment with either rosuvastatin 20 mg, atorvastatin 80mg or placebo during~     either 3 or 7 days~      Main study parameters: Difference in flow mediated dilation before and after 15 minutes~     ischemia.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Treatment with rosuvastatin or atorvastatin is not expected to harm the~     volunteers. Most reported side effects of rosuvastatin and atorvastatin are gastro‐intestinal~     complains and myalgia. The volunteers will not benefit directly from participating in this~     study.~   "
196756|NCT00987961|"~     This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization,~     and then providing an appointment (a link) for after discharge to maintenance buprenorphine~     in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.~   "
196757|NCT00987948|"~     High levels of HIV infection within blood monocyte/macrophages (a type of white cells in the~     bloodstream) increases risk of dementia in HIV-infected individuals. Maraviroc (Selzentry) is~     a HIV medication that works by blocking the entry of HIV in cells including~     monocytes/macrophages that use a receptor called CCR5. The study hypothesis is that the~     addition of Maraviroc to a HIV antiretroviral regimen in HIV-infected individuals with high~     levels of HIV-infected monocyte/macrophages will lead to a decrease in the levels of infected~     monocyte/macrophages and to decrease in brain inflammation as studied by magnetic resonance~     spectroscopy (MRS, a form of MRI study).~   "
196758|NCT00987935|"~     This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver~     cancer patients~   "
196759|NCT00987922|"~     Hypothesis: Mild hypothermia using non-invasive temperature management system in a stroke~     unit is safe and feasible in spontaneously breathing, alteplase-thrombolyzed patients with~     acute ischemic stroke.~   "
196760|NCT00987909|"~     The main purpose of this trial is to investigate if any of three different doses of cat hair~     immunotherapy is safe for treatment of cat allergic patients.~   "
196761|NCT00987896|"~     Megachannel is a newly developed colonic access system allowing rapid and multiple passes of~     the colonoscope to the right colon.~      The investigators want to conduct a multinational study to evaluate the safety and clinical~     feasibility of placing a 100 cm Megachannel prototype in the right colon.~   "
196762|NCT00987883|"~     Undernutrition is a state marked by energy and/or protein intake deficiency or~     mal-absorption, and is often described as protein energy malnutrition (PEM). Malnutrition is~     common in hospitalized patients worldwide. The prevalence of malnutrition in hospitalized~     patients range from 20% - 50%, depends on the varieties of diseases, health system,~     population and assessment tools. It is well documented in Western countries that malnutrition~     affects clinical outcomes negatively. Compared with well-nourished patients, patients with~     malnutrition stay longer in hospitals and related cost is significantly higher.~      There is increasing evidence which indicates that appropriate nutrition support (e.g.,~     standardized nutrition screening procedures, delivering nutrients with appropriate path, etc)~     may improve clinical outcome on malnutrition, along with cost saving.~      To date, there is no study to document specifically the impact of malnutrition and related~     nutrition support on the health economics in China. Considering China now is on its way to~     establish public health security system and a diagnosis-related grouping system, the~     understanding of the cost effectiveness of nutrition support under the current clinical~     conditions is crucial.~      This study aims to investigate the prevalence of perioperational malnutrition in~     gastroenterological cancer patient, the nutrition support status and related health economic~     effects.~   "
196763|NCT00987870|"~     This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety~     after multiple dosing.~   "
196764|NCT00987857|"~     RATIONALE: Screening tests may help doctors find cancer cells early and plan better~     treatment. It is not yet known whether endoscopy every 2 years is more effective than~     endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus.~      PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well~     it works compared with endoscopy only as needed in monitoring patients with Barrett~     esophagus.~   "
196765|NCT00987844|"~     Objectives: To evaluate the clinical long-term safety and the tolerability, patient~     satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg~     per day to patients with chronic constipation (CC).~   "
196766|NCT00987831|"~     Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted~     immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the~     variable effects on immune homeostasis of the background medications that must be continued,~     in most study designs, in these flare-prone patients.~      Purpose of Study: This study was designed to purposefully study a population equivalent to~     the placebo group of typical trials in SLE. In Group A patients entered the trial in~     mild-moderate flare, were treated with depomedrol, and any background immune suppressants~     withdrawn. Biomarkers at entry on various medications can be compared to biomarkers after~     steroid efficacy with background immune suppressants withdrawn. Depomedrol usually wears off~     over one to three months. Patients were closely observed, with serial biomarkers drawn at~     monthly intervals or immediately at the time of a new flare. Those patients developing new~     flares donated blood samples, were immediately treated as deemed appropriate, exiting the~     study. Group A was designed for up to 50 patients and recruited a total of 41. An additional~     group of 62 SLE patients donated blood once without additional interventions in order to~     increase the power of exploratory cross-sectional biomarker analysis on different immune~     suppressants (Group B). A control population of matched, healthy individuals donated blood~     twice for the same biomarker studies to validate these assays (Group C).~   "
196767|NCT00987818|"~     The adequacy of early empiric antimicrobial therapy is an important factor in determining the~     outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these~     patients however is less clear. Duration of antibiotic therapy in patients with sepsis in the~     ICU based on inflammatory markers has not been extensively studied.~      Procalcitonin (PCT) is an acute phase protein that has prognostic value in critically ill~     patients and can be used to monitor disease activity in sepsis and systemic inflammation.~     This study will examine the effect of PCT guided antibiotic therapy compared with~     conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the~     ICU.~   "
196768|NCT00987805|"~     The purpose of this study is to assess efficacy based on Gastrointestinal Symptom score and~     safety based on the rate of adverse event or laboratory findings of Banhasasim-tang~     administrated three times a day orally on functional dyspepsia.~   "
196769|NCT00987792|"~     The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP)~     patients on the disease including disease severity, clinical signs and symptoms and measures~     used for diagnosis in daily routine practice as well as data on Avelox® including information~     on the use, effectiveness, treatment outcome, safety and tolerability.~      As this is a non-interventional observational study, routine clinical practice is observed.~     The application of medications follows the normal routines and is decided by the treating~     physician under recognition of the package insert.~   "
196771|NCT00987766|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and~     oxaliplatin together with erlotinib hydrochloride may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib~     hydrochloride when given together with gemcitabine hydrochloride and oxaliplatin in treating~     patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary~     cancer.~   "
196772|NCT00987753|"~     The primary purpose of this study is to (1) determine the maximally tolerated dose (MTD) of~     L-377202 administered once every 3 weeks, (2) evaluate the safety and tolerability of~     L-377202 including the dose-limiting adverse effects of treatment with L-377202, and (3)~     assess the pharmacokinetics of various doses of L-377202 and the plasma profile of liberated~     doxorubicin and leu-doxorubicin.~   "
196773|NCT00987740|"~     The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory~     Assist System in patients with hypercapnic respiratory failure associated with acute~     exacerbation of chronic obstructive pulmonary disease (COPD) and a 50% likelihood of failure~     of noninvasive positive pressure ventilation leading to intubation and mechanical~     ventilation.~   "
196774|NCT00987727|"~     This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity~     in symptomatic dry eye condition in absence of obvious eye-lid inflammation.~   "
196775|NCT00987714|"~     The objective of this study is to determine whether protocol guided resuscitation of brain~     dead organ donors using Pulse Pressure Variation (PPV) will increase the number of organs~     transplanted per donor.~      Specifically the study aims to:~        1. improve resuscitation of potential organ donors.~        2. improve organ function in donors.~        3. increase organ recovery per donor.~      The investigators will randomize 960 subjects to either protocolized resuscitation (n=480)~     using a consensus-based PPV-guided algorithm or usual care using a 1:1 randomization scheme.~     The primary outcome is the mean number of organs transplanted per donor. Secondary outcomes~     include 6mHFS (six-month hospital-free survival) in the recipients, and mean number of organs~     procured per donor that are suitable for transplantation (intention to transplant). The study~     is powered to detect a 0.5 organ increase for transplantation per donor.~   "
196776|NCT00987701|"~     Early change in neurobehavior is strongly associated with the intelligence development of~     children. Previous studies reported that cesarean section itself could influence the later~     development of children. In addition, neuraxial anesthesia including epidural, spinal and~     combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery,~     and these anesthesia techniques will undoubtedly evoke hypotension and corresponding~     hemodynamic alteration, of which would result in decreasing in umbilical placental~     insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants.~     Fluid management, such as crystalloid and colloid, is the common ones given before or / and~     after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown~     whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior~     scorings, and could produce positive effect on later intelligence development. Herein the~     investigators hypothesized that effective perineuraxial anesthesia fluid management during~     cesarean section would prevent the occurrence of hypotension and improve infant's~     neurobehavior scorings.~   "
196777|NCT00987688|"~     Traumatic brain injury (TBI) is a leading cause of death and long term disability,~     particularly in young adults. Studies from Australia have shown that approximately half of~     those with severe traumatic brain injury will be severely disabled or dead 6 months post~     injury. Given the young age of many patients with severe TBI and the long term prevalence of~     major disability, the economic and more importantly the social cost to the community is very~     high.~      Pre-hospital and hospital management of patients with severe brain injury focuses on~     prevention of additional injury due primarily to lack of oxygen and insufficient blood~     pressure. This includes optimising sedation and ventilation, maintaining the fluid balance~     and draining Cerebrospinal Fluid (CSF) and performing surgery where appropriate. In recent~     years there has been a research focus on specific pharmacologic interventions, however, to~     date, there has been no treatment that has been associated with improvement of neurological~     outcomes.~      One treatment that shows promise is the application of hypothermia (cooling). This treatment~     is commonly used in Australia to decrease brain injury in patients with brain injury~     following out-of-hospital cardiac arrest. Cooling is thought to protect the brain using a~     number of mechanisms. There have been a number of animal studies that have looked at how~     cooling is protective and also some clinical research that suggests some benefit. However at~     the current time there is insufficient evidence to provide enough proof that cooling should~     be used routinely for patients with brain injury and like all treatments there can be some~     risks and side effects.~      The POLAR trial has been developed to investigate whether early cooling of patients with~     severe traumatic brain injury is associated with better outcomes. It is a randomised~     controlled trial, which is a type of trial that provides the highest quality of evidence.~      The null hypothesis is that there is no difference in the proportion of favourable~     neurological outcomes six months after severe traumatic brain injury in patients treated with~     early and sustained hypothermia, compared to standard normothermic management.~   "
196778|NCT00987675|"~     RATIONALE: High-intensity focused ultrasound ablation uses high-energy sound waves to kill~     tumor cells.~      PURPOSE: This phase II trial is studying the side effects of high-intensity focused~     ultrasound ablation and to see how well it works in treating patients with progressive~     prostate cancer.~   "
196779|NCT00987662|"~     Objective:~        1. To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory~          blood pressure values in obese subjects~        2. To study the drug specific effect in arterial stiffness~        3. To study possible drug mechanisms in obesity (reduction of central adiposity and~          changing the ratio of leptin to adiponectin)~   "
196780|NCT00987649|"~     The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA)~     is effective in the determination of a woman's risk of cancer when she is scheduled to have~     surgery to remove a pelvic mass.~      After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood~     sample will be collected within 30 days of the surgical procedure. Results of the surgical~     procedure will be collected and analyzed against the CA125 and HE4 results used in the~     calculation of the ROMA.~   "
196805|NCT00987324|"~     The purpose of this randomized study is to determine which treatment option, either~     paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most~     effective in the treatment of restenosis after implantation of Limus-eluting stents, (LES).~   "
196806|NCT00987311|"~     The purpose of this study is to investigate whether two different fermented dairy drinks~     consumed daily could have an effect on the intestinal immune response in healthy subjects.~   "
196781|NCT00987636|"~     Ewing Sarcoma~      Primary objectives:~      Standard Risk R1: in a randomised trial, to examine whether add-on treatment with zoledronic~     acid in addition to induction and maintenance chemotherapy improves event-free survival in~     patients with localised Ewing sarcoma and good histological response or with initial tumour~     volume <200 mL compared to no add-on treatment.~      *High Risk R2: in a randomised trial, to examine whether high-dose chemotherapy using~     busulfan-melphalan with autologous stem cell reinfusion, compared with standard chemotherapy,~     improves event-free survival in patients with localised Ewing sarcoma and poor histological~     response or tumour volume ≥200 mL (R2loc). In patients with pulmonary metastases high dose~     busulfan-melphalan chemotherapy with autologous stem cell reinfusion is randomised versus~     standard chemotherapy plus whole lung irradiation (R2pulm).~      Very High Risk R3: in a randomised trial, to examine whether the addition of high dose~     chemotherapy using treosulfan-melphalan followed by autologous stem cell reinfusion to eight~     cycles of standard adjuvant chemotherapy, compared to eight cycles of standard adjuvant~     chemotherapy alone, improves event-free survival in patients with primary disseminated~     disease.~      *R2 accrual discontinued on December 1st 2015.~   "
196782|NCT00987623|"~     The purpose of this study is to evaluate the performance of two daily disposable contact~     lenses in a population of neophytes (new wearers).~   "
196783|NCT00987610|"~     Under the circumstances that appropriate first-choice guidewires for percutaneous coronary~     intervention (PCI) for chronic total occlusion (CTO) have yet to be established, the~     objective of this study is to determine appropriate first-choice guidewires. G-FORCE study is~     a prospective multicenter randomized study between normal (distal tip size 0.014 inch) and~     slender (distal tip size 0.010 inch or less) guidewires. Primary end point is lesion~     penetration rate of the first choice guidewire.~   "
196784|NCT00987597|"~     The aim of the present study is to assess if a personal care program of smokers hospitalised~     for acute coronary syndrome can change the smoking habits as compared with similar patients~     in conventional care program at 6 months. The program includes a cognitive-behavioural~     approach associated with a nicotine replacement treatment presented as an obligatory non~     optional treatment. Patients are men and women of less than 70 years old hospitalised for~     acute coronary syndrome. Major exclusion criteria is the presence of another dependence. The~     program includes a cognitive-behavioural approach based on the specific technique of~     exposure and the prescription of nicotine patch considered as other usual cardiologic~     treatments for at least 6 months. The end point is the smoking habits at 6 months classified~     as: no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by~     the patient but a CO level > 10 ppm). 72 patients in each group will be included in 2 majors~     sites.~   "
196785|NCT00987584|"~     This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes~     (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples~     taken from participants participating in a clinical trial evaluating the efficacy and safety~     of investigational agent ON 01910.Na (eProtocol 16214). This study will use existing blood~     and marrow samples to determine the rate and duration of objective hematologic and marrow~     responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.~      This study will use existing blood and marrow samples to determine the rate and duration of~     objective hematologic and marrow responses, and duration of progression-free survival in~     ON01910.Na-treated MDS patients.~   "
196786|NCT00987571|"~     Carpal tunnel syndrome is caused by compression of the median nerve at the wrist. The~     hypothesis is that ultrasound imaging can be used to visualize nerve compression in carpal~     tunnel patients during hand activity, and normal subjects will not demonstrate any nerve~     compression.~   "
196787|NCT00987558|"~     The primary objective was to investigate whether multiple-dose administration of ESL 800 mg~     once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.~   "
196788|NCT00987545|"~     This is a 2-part study. In the first part (Part I, 8 subjects), biopsies will be obtained~     from the resection site after keloid shaving and two weeks following resection to assess and~     select biomarkers to determine the biologic effects that occur in shaved keloids. No drug~     will be administered.~      In Part II (32 patients) will be randomized to receive QAX576 or placebo. An initial drug~     infusion will be followed by shave removal of keloids 6 - 8 days later followed by two~     additional drug infusions 4 weeks apart. Two weeks following resection, punch biopsies will~     be performed to assess biomarker responses. Patients will be followed-up for 52 weeks after~     first drug administration to assess keloid recurrence (clinically and by 3D imaging), and by~     physician's and patient's cosmetic assessments, and safety.~   "
196789|NCT00987532|"~     The aim of this study is to test whether a parent-focused participatory intervention in~     addition to gym lessons can enhance preschoolers physical activity compared to gym lessons~     alone.~   "
196790|NCT00987519|"~     With the use of molecular methods new viruses have been detected in respiratory and~     gastrointestinal tracts of both patients and asymptomatic subjects in recent years. The~     clinical importance of these viruses has not been adequately studied.~      The aim of this study is to use molecular methods to detect viruses in upper respiratory~     tract and gastrointestinal tract of children with acute bronchiolitis, acute gastroenteritis~     and febrile convulsions and to try to correlate the severity of clinical picture with the~     amount of viruses present in clinical samples. The investigators will also try to detect the~     increase in specific antibodies in paired sera.~   "
196791|NCT00987506|"~     The objective of this study is to prepare elements of response to the Haute Autorité de Santé~     (High Health Authority) of France, which is expecting data relating to the routine use of~     XIENCE V® endoprothesis within the 5 years following its marketing.~   "
196792|NCT00987493|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cell-killing substances to them. Drugs used in~     chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide~     may stop the growth of cancer by blocking blood flow to the tumor. Giving rituximab together~     with bendamustine hydrochloride and lenalidomide may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving rituximab~     together with bendamustine hydrochloride and lenalidomide in treating patients with~     aggressive B-cell lymphoma.~   "
196793|NCT00987480|"~     This is a genetic disease (transmitted through the parents' genes) called Fanconi Anemia.~     Because of that genetic disease, the bone marrow has changed and now has failed, or has given~     rise to a preleukemia called myelodysplastic syndrome (MDS) or leukemia (acute myelogenous~     leukemia or AML).~      Without treatment these complications of Fanconia anemia (FA) are fatal. The only treatment~     that can cure these complications is an allogeneic transplant of stem cells, meaning, giving~     the patient bone marrow cells from a healthy donor that can produce normal blood cells that~     will replace the bone marrow that is sick.~      What has been given for the treatment of FA in the past is to use a combination of low doses~     of radiation to the whole body (total body irradiation) and low doses of the chemotherapy~     drugs (cyclophosphamide and fludarabine) before the transplant. However, the use of radiation~     can, later on, increase the chances of getting a second cancer of the skin, head or the neck.~     These chances of a second cancer are higher than normal in patients with FA.~      The purpose of this study is to find out if the doctors can do the same thing with the same~     chemotherapy drugs used in the past. However physicians will use another chemotherapy drug~     called busulfan instead of the radiation. The goal of this study is to get rid of the short~     term and long term risks of the radiation. The first new part of this treatment will be to~     replace drugs for radiation with chemotherapy drugs.~   "
196794|NCT00987467|"~     Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated~     with eczema. Over time, the complications from this disease process lead to loss of vision~     due to continual scarring of the corneal surface. The pathophysiology of AKC has not been~     fully elucidated, and the triggers are still unknown.~      Corticosteroids are very effective in controlling the acute symptoms of AKC. However, two~     thirds of patients managed with a combination of oral antihistamine, topical mast cell~     stabilizer, and intermittent topical steroid regimen eventually developed significant~     keratopathy and vision loss. Additionally, there are many side effects of corticosteroids,~     including local immunosuppression, cataract formation, and increased risk of glaucoma.~      Cyclosporin A is an immunomodulator that specifically inhibits T lymphocytes by blocking the~     expression of the interleukin-2 receptor. It also blocks the release of inflammatory~     mediators from mast cells and eosinophils. Cyclosporin has no known side effects except for~     burning upon instillation, and safe to use over long-term . The investigators have~     demonstrated that a 0.05% ophthalmic emulsion of cyclosporine has been shown to be effective~     at improving the ocular signs and symptoms of AKC over short-term. However, the long-term~     efficacy of cyclosporine A in slowing the natural history of AKC and possible steroid sparing~     effects have not been assessed. The investigators hypothesize that cyclosporine A can be used~     as a mainstay treatment of AKC to control signs and symptoms over a long period of time and~     also prevent the progression of this disease.~   "
196795|NCT00987454|"~     This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical~     care patients with moderate or severe traumatic brain injury improves neurological function~     assessed at six months after injury.~   "
196796|NCT00987441|"~     Infant neurobehavior alteration is predictor of later intelligence development. Many factors~     would influence or are associated with infant neurobehavior, of which exist or appear during~     perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective~     method in relieving labor pain. Although previous studies showed that opioid used in epidural~     analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation~     associated manner, whether epidural analgesia itself would produce unpredictable effect on~     newborn neurobehavior is still unknown. Hereby the investigators designed this trial to~     investigate the hypothesis that epidural analgesia for labor pain control itself would not~     produce negative effect on infant neurobehavior.~   "
196797|NCT00987428|"~     The primary purpose of this trial is to determine whether an early Early Endoscopic~     Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile~     duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis~     (ABP).~   "
196798|NCT00987415|"~     The purpose of this study is to determine whether allopurinol is effective in relieving~     symptoms of patients with heart failure and high blood uric acid levels.~   "
196799|NCT00987402|"~     Surgical site infections (SSI) constitute a significant health-economic and clinical~     challenge. The investigators conducted a cluster-randomized, cross-over study to compare the~     efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for~     surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main~     outcome measure.~      A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the~     study and followed up for 30 days.~   "
196800|NCT00987389|"~     The purpose of this study is to determine whether plasma exchange as well as~     immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD).~     The trial will also study whether a reduced cumulative dosing regimen of glucocorticoids is~     as effective as a standard disease regimen.~      The FDA-OOPD is one of the funding sources for this study.~   "
196801|NCT00987376|"~     Prostate cancer imaging using traditional anatomic modalities including CT, MR, and~     ultrasound is limited. Improvement in current imaging modalities or development of new ones~     should be a priority in prostate cancer research. Optimal treatment varies considerably for~     patients with different staging characterizations and new imaging methods that more~     accurately stage patients could lead to more appropriate treatment. The objective of this~     study is to obtain preliminary, comparative data on new, promising imaging methods for~     prostate cancer. PET/CT imaging using 11C-choline,11C-acetate, and Y86 or~     18F-Adenosylcobalamin and MRI spectroscopy (MRS) of prostate cancer will be compared. Direct~     comparison of these imaging methods has never been done and Mayo Clinic and Johns Hopkins are~     uniquely able to conduct such a trial as an inter-SPORE collaboration.~   "
196802|NCT00987363|"~     The aim of the study is to evaluate the safety and feasibility of autologous bone marrow~     mononuclear cells autologous administered intra-arterially in the affected limb of diabetic~     patients with chronic critical ischemia of the lower limbs (CLI) without possibility of~     revascularization or other therapeutic alternatives.~      The trial hypothesis we propose consists of mononuclear cells of bone marrow providing~     progenitor cells with regenerative capacity and secrete also several angiogenic factors, and~     their implantation into ischemic tissues with both elements should contribute to angiogenesis~     and tissue regeneration with recovery of the circulation in the affected limb~   "
196808|NCT00987285|"~     This project is primarily a behavioral study. We employed a three-arm, patient-randomized~     practical effectiveness trial to evaluate the impact of two different interactive, multimedia~     self-management programs, relative to enhanced usual care. The two interventions will be~     (a) the revised program from our present study, based on our social-ecological theory and the~     5 As self-management model, plus enhanced support (ASM+ES) that includes practical, but~     extensive, ongoing support and b) largely Automated Self-Management (ASM). These programs~     will be compared to a realistic enhanced usual care (UC) condition that will provide health~     risk appraisal feedback, control for computer interactions, and provide standardized advice~     on behavior change, but not the hypothesized key intervention processes of goal-setting,~     barriers identification, problem-solving, or social-environmental support. Patients will be~     randomized to conditions within clinic and will participate for 1 year.~      The proposed project will test the effectiveness of a practical, automated-based intervention~     for primary care patients to facilitate dietary and physical activity practices, and~     medication-taking. Analyses will focus on primary outcomes of (a) dietary, physical activity,~     medication-taking outcomes, and (b) the UKPDS risk equation as well as secondary~     quality-of-life, patient-activation, and patient care outcomes (Specific Aim #2). Using the~     RE-AIM measures, we will analyze the reach, effectiveness, adoption, implementation, and~     maintenance of the intervention programs (Specific Aim #3), and also factors related to~     program implementation, linkage to primary care, and program success with emphasis on cost,~     cost-effectiveness, and mediators and moderators of outcomes such as social-environment~     support (Aim #4).~      Primary hypotheses:~        1. That the Automated Intervention received by Automated self-management (ASM) condition~          and ASM plus enhanced support conditions (ASM+ES) will be superior to usual care on the~          primary outcomes.~        2. That the ASM+ES condition will be superior to the ASM alone condition on primary~          outcomes at the 12-month follow-up.~   "
196809|NCT00987272|"~     The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared~     to its vehicle in Japanese subjects in the treatment of acute allergen-mediated~     conjunctivitis using the conjunctival allergen challenge (CAC) test.~   "
196810|NCT00987259|"~     Despite recent improvements in treatment, myocardial infarction (heart attack) is still a~     leading cause of illness and death in the UK. Following the acute event, it is difficult to~     predict which patients are at risk of further problems, such as heart failure and is~     therefore difficult to know which patients need more aggressive/intensive treatment and~     monitoring.~      There needs to be a test which is safe, reliable and reproducible that can be used shortly~     after a heart attack to both predict future cardiac events and to allow the efficacy of new~     treatments to be assessed.~      Myocardial oedema (swelling of the heart muscle) has been demonstrated using Cardiac Magnetic~     Resonance (CMR), to occur following a heart attack and has been suggested as a marker for~     future cardiac events. The optimum time to perform this scan, the method of data analysis and~     it's effectiveness as a predictor of future cardiac events has not been adequately assessed.~      This trial will assess the amount and natural time-course of oedema in the first 10 days~     following a heart attack. It will also correlate the amount of oedema with the size of scar~     (damaged heart muscle) and left ventricular ejection fraction (heart function) at 3 months to~     assess if it is a predictive marker.~   "
196811|NCT00987246|"~     The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo~     and to LAS106521 in actinic keratosis (AK).~   "
196812|NCT00987233|"~     A randomized, double-blind, placebo-controlled parallel-group study, comparing the~     bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of~     Nasacort® AQ nasal spray (Sanofi-Aventis Pharmaceutical Products, Inc.) in the treatment of~     seasonal allergic rhinitis.~   "
196813|NCT00987220|"~     It is hypothesized that the acetylcholinesterase inhibitor, donepezil, will increase acute~     cerebrospinal fluid (CSF) actylcholine levels in healthy volunteers following a 5mg single~     dose oral administration.~   "
196814|NCT00987207|"~     Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a~     cardioprotection during the valvular surgery.~   "
196815|NCT00987194|"~     Background Recently, the CDC issued recommendations calling for HIV screening for patients~     aged 13-64, when the individual accesses the health care system. For many patients, the~     emergency department (ED) is the primary or only contact point for health care. The rapid HIV~     test can be done as a point of care test in the ED.~      Study Objectives~      A. Primary:~      1. To initiate HIV testing in the Baystate ED.~      B. Secondary:~        1. To estimate the resources involved in initiating a rapid HIV testing program in the ED.~        2. To describe the process of initiating a rapid HIV testing program.~        3. To compare the yield of testing for HIV in patients with known HIV risk factors compared~          to those without known risk factors.~        4. To describe the characteristics of the population tested for HIV in the ED.~        5. To determine the number of patients who declined testing and the reasons for declining~          testing.~        6. To analyze ED staff attitudes re: HIV rapid testing in the ED.~      Methods A trained HIV Educator/counselor will approach patients in the ED to offer free rapid~     HIV testing, at a time they are not currently engaged with the health care provider. Study~     informed consent and HIV consent will be obtained prior to testing. The HIV educator will~     obtain demographic and clinical information on the enrolled subjects including prior HIV~     testing and HIV risk factors. Patients testing negative will be counseled regarding HIV risk~     reduction strategies. Patients with an initial positive rapid HIV test will have blood drawn~     for confirmation (Western Blot) and will be referred to an HIV clinic for follow-up and~     treatment. Additionally, to assess acceptability of rapid testing in the ED, a brief~     anonymous electronic survey will be conducted of health care providers in the ED prior to~     starting this pilot program and following the program.~      Data Analysis The yield of testing will be calculated as will the seroprevalence of those~     tested. Among patients who decline HIV testing but agree to study participation (sign consent~     form), the number refusing testing will be recorded and reasons for refusing will be~     analyzed. The yield of testing will be compared in patients with to those without known HIV~     risk factors.~   "
196816|NCT00987181|"~     Reduced aortic stiffness is a powerful way to predict the outcome of cardiovascular (CV)~     disease. There are several non invasive methods for its estimation, most of which are based~     on the measurement of speed of the arterial pulse wave. (The stiffer the artery, the faster~     the pulse wave travels.) They rely on detecting the arterial pulse with 2 sensors placed on~     the skin a known distance apart and measuring the time for the pulse to travel between them.~     However all current methods require skilled operators and are of limited accuracy. Thus,~     there is a need for an easy to use and reliable device to measure pulse speed. The aim of~     this project is to develop a non contact device to detect the aortic pulse as it moves into~     the small arteries following the ribs, using the principle of thermal imaging, by means of a~     high sensitivity infra red camera, directed towards the subjects back. The investigators plan~     to validate the device and conduct a small feasibility study in patients undergoing elective~     angiography, by simultaneously measuring pulse speed using established methods. These are~     Doppler ultrasound (non-invasive) and direct intra-arterial measurement (the gold standard).~   "
196817|NCT00987168|"~     To replace Sandostatine® in three daily subcutaneous injections by a single intramuscular~     injection of Sandostatine® LP per month in patients with a diffuse form of hyperinsulinism.~   "
196865|NCT00986492|"~     Evidence that shortened period of sleep could be a risk factor for weight gain and obesity~     has grown over the past decade. Concurrent with the obesity epidemic, numerous studies have~     reported a parallel epidemic of chronic sleep deprivation. Sleep is important in maintaining~     energy balance (i.e. acute sleep deprivation impact the normal secretion of ghrelin and~     decreases leptin plasma levels). Surprisingly, in humans, there is no direct evidence that a~     shortened night has direct effect on energy metabolism during the following day.~      This study is set up to determine whether a partial sleep deprivation night has an impact on~     appetite and food energy intake and, concomitantly, on physical activity, during the~     following day.~   "
196818|NCT00987155|"~     1. Measurements of peak oxygen uptake (VO2peak) during passive leg cycling (PLC) combined~          with arm crank ergometry (ACE), leg vascular occlusion (100mmHg above systolic BP)~          combined with ACE, and FES isometric contractions combined with ACE in spinal cord~          injured (SCI). All the above mentioned parameters will be compared to Functional~          Electrical Stimulated (FES) lower extremity cycling combined with ACE (FEShybrid). The~          hypothesis is that VO2peak is significantly higher during FES hybrid cycling when~          compared to peak and submaximal PLC, leg vascular occlusion and ACE. But the values for~          VO2peak during FES isometric contractions combined with ACE is not significantly~          different from FES hybrid cycling.~        2. Comparison of sub-maximal and peak VO2 values during arm crank (ACE) and wheelchair~          ergometry (WCE) in persons with spinal cord injury. The hypothesis is that wheelchair~          propulsion due to higher energy expenditure show higher work output and VO2peak than~          ACE.~        3. Does 6 weeks of maximal strength training improve SCI subjects performance during WCE?~          WCE after 6 weeks maximal strength training is less strenuous owing to better work~          economy/ efficiency.~        4. Effect from aerobic high intensity hybrid training on stroke volume (SV) and VO2peak in~          spinal cord injured men.~      8 weeks of high intensity 4 times 4 interval training at 85-90% of peak heart rate during~     hybrid cycling. Hypothesis; VO2peak and SV will be significantly increased from training.~   "
196819|NCT00987142|"~     A phase II, comparative, open label, prospective, multicentre clinical trial where each~     patient will undergo two procedures; implant of a patch of cultured chimeric skin~     (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing~     (control) in the other half for 12 months of follow-up in two Spanish centres.~   "
196820|NCT00987129|"~     Docosahexaenoic acid (DHA) supplementation has been shown to prevent specific age-related~     changes in the retina through biochemical and functional evaluations, but it is unclear~     whether increased DHA intake-reflected through elevated DHA+EPA blood levels-can affect the~     natural history and progression of age-related macular degeneration (AMD). AMD is a disease~     affecting the macula, the part of the eye containing cone photoreceptors at the center of the~     visual field. The macula is responsible for vision in most daily functions, including~     reading, seeing fine details, and colour recognition. Severe AMD can lead to a central~     scotoma, severely impairing daily functioning. AMD can be divided into two forms: the more~     severe wet AMD, consisting of proliferation of new blood vessels in the retina, and dry AMD~     characterized by the development of drusen, a buildup of extracellular material . The~     investigators are focused on the group with the highest risk of developing the two advanced~     forms of AMD [wet AMD or central geographic atrophy]: patients with unilateral wet AMD and~     dry AMD in their other eye. The study will consist of following up a cohort of such subjects~     and monitoring their visual function in a comprehensive manner. Working in concert with~     clinical ophthalmologists and basic scientists, the investigators will monitor DHA+EPA and~     Omega6:Omega3 fatty acid ratio levels in the blood, inherited predispositions through~     genetic analysis, lipofuscin (an accumulated waste product) levels & AMD progression via~     fundus photography, visual acuity, and retinal function via full-field and multifocal~     electroretinograms. These different factors will be cross-correlated and evaluated to~     determine how omega-3 fatty acids affect the progression of AMD.~   "
196821|NCT00987116|"~     Pathology - Generalized myasthenia gravis (MG) is cause of muscle weakness that can have a~     significant impact on daily life activity but can also be, when respiratory or bulbar muscles~     are involved, life-threatening.~      Rationale - Additionally to thymectomy, which indication of is still debated in absence of~     thymoma, the long-term treatment of generalized myasthenia gravis includes usually prednisone~     and azathioprine. However, the most used scheme for prescribing and tapering corticosteroid~     in MG resulted in a very important cumulative dose of prednisone. Indeed, at twelve month,~     more than 50 percent of patients are still daily treated with at least 18 mg of prednisone~     and the proportion of patients who are in remission and no longer taking prednisone is very~     low (Palace and NEWSOM Davis, Neurology 1998). Prolonged corticosteroid therapy is~     accompanied with various and major side effects, hypertension, osteoporosis, weight gain,~     glaucoma. Therefore, tapering, eventually discontinuing, prednisone earlier is a relevant~     therapeutic goal.~      For this reason, the investigators will compare to the standard one, a strategy consisting of~     a rapid decrease in corticosteroid.~      Objective - To assess whether, in patients with generalized MG requiring a long-term~     treatment with corticosteroids and azathioprine, that the strategy of rapid tapering allows~     discontinuing more rapidly the prednisone for equivalent efficacy than the classical~     strategy.~   "
196822|NCT00987103|"~     The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual~     administration of tacrolimus and to compare with pharmacokinetics after oral administration~     of tacrolimus in renal transplant patients before transplantation.~   "
196823|NCT00987090|"~     Alzheimer's disease (AD) is usually associated with aging, age being the principal identified~     risk factor. However, younger subjects also develop AD and the prevalence of early onset AD~     is unknown. It is estimated that about 30 000 subjects develop symptoms of AD before the age~     of 65 in France. There is evidence that early onset AD differs from AD in older patients. In~     particular, clinical and neuroimaging studies suggest early involvement of neocortical brain~     regions and their functions in early onset AD, while mediotemporal areas and memory might be~     more involved in late onset AD. These differences could partly explain the atypical clinical~     and imaging features of younger patients, the diagnostic difficulties in these patients and~     the specific problems related to medical care of this age group. The present study uses a~     multidisciplinary approach with longitudinal followup in order to establish the impact of age~     on the clinical and neuroimaging picture of sporadic AD in a multicentric setting. Another~     aim of the project is to describe for each age group, and in particular for the younger~     patient group, the functional impact of disability in everyday life on both, patients and~     caregivers.~   "
196866|NCT00986479|"~     The purpose of this study is to determine the antidepressant effects of AZD6765 compared to~     placebo.~   "
196886|NCT00986206|"~     RATIONALE: Screening tests, such as the lysophosphatidic acid assay, may help doctors find~     cancer cells early and plan better treatment for ovarian cancer.~      PURPOSE: This clinical trial is studying using the lysophosphatidic acid assay to see how~     well it works in early detection of ovarian cancer in patients with ovarian cancer or who are~     at risk for ovarian cancer.~   "
196824|NCT00987077|"~     The purpose of this study is to evaluate the efficacy of Selective Retina Therapy (SRT) for~     treating acute idiopathic central serous chorioretinopathy (ICSC). Patients with acute~     symptomatic ICSC of at least 3 months duration were recruited. The patients were randomized~     by equal terms to SRT- (Treatment) and control group. After 3 months follow up patients of~     control group with persistence of disease activity were allocated to crossover group and~     received either SRT. Crossover group was followed up for further 3 months.~      The primary outcome measure of the study are the serial changes in Early Treatment of~     Diabetic Retinopathy Study (ETDRS) letterscore and edema in optical coherence tomography~     (OCT) at 3 months. Secondary outcome measures included the proportion of eyes with complete~     absorption of subretinal fluid, leakage in fluorescein angiography and the systemic and~     ocular complications during the study at 3 months.~   "
196825|NCT00987064|"~     The purpose of this study is to determine whether clean air administered to the breathing~     zone with Temperature controlled Laminar Airflow (TLA) during night is effective in the~     treatment of perennial allergic asthma.~   "
196826|NCT00987051|"~     The purpose of this study is to investigate the relevance of sentinel node in endometrial~     cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women~     with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is~     questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an~     alternative to complete lymphadenectomy.~   "
196827|NCT00987038|"~     The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on~     the blood levels (pharmacokinetics) of midazolam~   "
196828|NCT00987025|"~     The purpose of TEAhM is to determine if telehealth blood pressure stations can be installed~     and used in senior nutrition centers and to do a preliminary comparison of blood pressure~     outcomes among nutrition center clients who use the telehealth blood pressure stations~     compared to participants who do not use the stations. Specifically, the goals of the project~     are to determine if these monitors can be successfully implemented in this community-based~     setting, the degree to which older adults with hypertension are comfortable using the~     technology, and whether remote nurse monitoring of blood pressure using this technology is a~     feasible supplement to office-based care.~   "
196829|NCT00987012|"~     It has been shown in laboratory studies that pomegranate juice contains anti-viral action~     against influenza. The researchers wish to investigate the effect of pomegranate juice on~     patients suffering from influenza A (seasonal or swine flu).~   "
196830|NCT00986999|"~     Rosuvastatin belongs to a class of medications commonly called statins which are~     medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent~     atherosclerosis (hardening of blood vessels) and lower risk of heart attacks and other~     circulation problems. Recent studies in the general non-HIV infected population have shown~     that the beneficial effect of statins in preventing circulation problems is larger than would~     be expected from lowering of LDL-cholesterol alone. It has been suggested that the additional~     beneficial effect of statins may be due to the anti-inflammatory effect of statins.~      The risk of heart attacks and other circulation problems may be high in HIV infected~     individuals. This may be due to the inflammatory stress effects of HIV. The main purpose of~     the study is to see if rosuvastatin will have a beneficial effect on the circulatory system~     in HIV infected individuals even in those who do not have high LDL cholesterol levels.~     Therefore, in HIV-infected individuals with normal or low LDL cholesterol levels but with~     evidence of low HDL cholesterol levels which may be a sign of low grade inflammation, the~     study will look at whether 3 months of rosuvastatin will lead to improvement in brachial~     artery flow-mediated dilatation (FMD), a marker of early atherosclerosis (hardening of the~     blood vessels).~   "
196831|NCT00986986|"~     This study is a pilot study examining the effect of extended-release niacin (Niaspan ®) on~     flow-mediated vasodilation (FMD) of the brachial artery, among human immunodeficiency virus~     (HIV)-1 infected individuals with low high density lipoprotein (HDL). Brachial artery~     diameter will be measured by high-resolution ultrasound at entry and week 12 of study. The~     primary comparisons will be change in FMD from baseline to 12 weeks within each of the two~     arms. The second specific aim will be to investigate the proportion of the effect of~     extended-release niacin on other known cardiovascular markers.~   "
196832|NCT00986973|"~     The aim of this pilot study is to determine if there are any changes in brain glucose~     metabolism in the gray matter of patients with Phenylketonuria (PKU) and whether~     administration of Sapropterin (KUVAN) therapy can improve such deficits.~   "
196833|NCT00986960|"~     The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is~     effective in the treatment of relapsing remitting multiple sclerosis.~   "
196834|NCT00986947|"~     Some patients who need kidney transplants have high levels of antibodies that make them~     incompatible with most potential deceased donor kidney offers. These patients are considered~     highly-sensitized and are very difficult to transplant because the likelihood that they will~     receive a compatible organ is very low. There are some medications and procedures that can~     decrease the antibody levels and this can increase the chance of finding a compatible donor~     for these patients. In this study the investigators will give two medications (IVIg and~     Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor~     kidney transplant. After the investigators administer these medications, the investigators~     will continue to check for compatibility as organ offers are received. If a compatible organ~     offer is received, the investigators will perform the transplant using that organ. The~     investigators hypothesize that these medications will lower antibody levels and increase the~     chance that a these patients are able to receive a compatible kidney transplant.~   "
196835|NCT00986921|"~     Women who are requesting pregnancy termination at 14-16 weeks, who would normally have~     osmotic dilator insertion the day before their procedure, would be asked if they wanted to~     participate. Participants would be randomized to two groups: first, dilator insertion as~     usual, or second, mifepristone taken the day before the procedure.~   "
196836|NCT00986895|"~     The purpose of this study is to determine the safety and tolerability of GT4P administered~     orally as a single dose, and twice daily for 7 consecutive days, to subjects with hepatic~     impairment with cirrhosis (Child-Pugh scores of A, B, or C) and to a gender matched and~     similar age control group with normal hepatic function.~   "
196837|NCT00986882|"~     The study will assess the analgesic efficacy and safety and tolerability of a single oral~     dose of SAF312 in postoperative dental pain patients after 3rd molar extraction.~   "
196838|NCT00986869|"~     Background~      Flexible bronchoscopy (FB) is one of the most common invasive procedures performed by~     pulmonologists (1) . Typically performed under topical anesthesia and conscious sedation, the~     procedure is considered to be safe, effective and well tolerated in patients with a wide~     variety of pulmonary diseases (2). Complications associated with the procedure are rare and~     studies have estimated an incidence of 0.5-4% (3) The most commonly recognized complications~     include hypoxia, bleeding, bronchospasm, cardiac dysrhythmias, pneumothorax, and vagal~     reactions (4). Several conditions increase the risk of complications including pre-existent~     hypoxemia, use of mechanical ventilation, uremia, profound thrombocytopenia, coagulopathy and~     pulmonary hypertension (PH) (5). Although previous reports suggest that transbronchial~     biopsies increase the risk for hemorrhage in this population, data are is limited to survey~     analyses and isolated reports. Recently Guzman et al. reported a retrospective analysis about~     the safety of FB in PH. (6) They found that FB can be performed safely in patients with mild~     and moderate PH. However, the study was small and retrospective analysis. Furthermore, there~     is no consensus regarding levels of pulmonary artery pressure (PAP) considered to be safe for~     invasive diagnostic interventions such as TBLB or transbronchial needle aspiration.~      Objective~      To assess the safety of FB in patients with PH and to study the occurrence of complications~     associated with different diagnostic bronchoscopic procedures.~   "
196839|NCT00986856|"~     To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment~     of impetigo in paediatric patients.~      To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a~     prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin®~     cream.~      To investigate the genetic relationship between S. aureus-strains isolated from impetigo~     patients.~   "
196840|NCT00986843|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of~     OratecanTM. Eligible subjects of this study are patients with histologically or cytologically~     confirmed malignant solid tumor refractory to standard therapy.~      The irinotecan hydrochloric acid (HCl) tablet is escalated and administered per body surface~     area (BSA). The dose of HM30181A 60 mg is fixed.~      The Route of administration of irinitecan and HM30181A is oral. Each cycle consists of 21~     days. Drugs are administered daily for 10 consecutive days (D1, 2, 3, 4, 5, 8, 9, 10, 11 and~     12) followed by a washout of 9 days.~   "
196841|NCT00986830|"~     A prospective, non-randomized trial to evaluate post-operative health care resource~     utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the~     physician's office.~   "
196842|NCT00986817|"~     Ascites is a common complication of cirrhosis. Sodium restriction and diuretics are the first~     step treatment. Refractory ascites (not responding to first step treatment) is treated with~     repeated large volume paracentesis followed by intra venous albumin expansion. In pilot~     studies vasoconstrictor agents such as terlipressin have shown beneficial effect on ascites~     production. Therefore the investigators will study the effect of combined therapy with~     albumin and terlipressin on recidivation ascites.~   "
196843|NCT00986804|"~     Primary:~      To determine the maximum tolerated dose and schedule of decitabine when administered as~     maintenance therapy after allogeneic hematopoietic stem cell transplantation (alloHSCT)~     performed for AML or high-risk MDS.~   "
196844|NCT00986791|"~     Hazardous alcohol intake is an independent risk factor for postoperative complications after~     major and minor operations, elective and emergency procedures for men and women.~      The aim of this study is to evaluate the effect of a 6-week Gold Standard Programme for~     alcohol cessation intervention in the perioperative period compared to the daily routine~     guidelines for patients with hazardous alcohol intake undergoing ankle fracture surgery.~   "
196845|NCT00986778|"~     Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity~     compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in~     Chinese adults with lamivudine-resistant chronic hepatitis B infection~   "
196846|NCT00986765|"~     Preeclampsia (PE) complicates 2-8% of pregnancies. It is associated with an increased risk of~     adverse maternal (death, eclampsia, abruptio placenta, HELLP syndrome) and perinatal~     (perinatal death, growth restriction, prematurity) outcomes. The only definite treatment of~     PE remains pregnancy termination. Therefore, prevention of PE remains an important challenge.~     Low dose aspirin may be used in the prevention of PE, particularly in women who had a severe~     preeclampsia before 34 weeks. Its efficiency, however, is very weak. Recently, it has been~     suggested that low molecular weight heparin might be useful in the prevention of PE.~      The aim of this study is to analyze the usefulness of the enoxaparin 4000 UI/day in the~     prevention of a composite maternal or perinatal morbidity (occurrence of one of the following~     events: maternal death, PE, fetal growth retardation, abruptio placenta, perinatal death) in~     women who previously had a severe preeclampsia at less than 34 weeks' gestation. To answer~     this question, the investigators propose to conduct a multicenter prospective randomized~     trial that will compare two groups in parallel: a group where women will have an association~     of enoxaparin 4000 U/day and aspirin 100 mg/day and another group where women would have only~     aspirin 100 mg/day. The number of patients needed is 255 (amendment n°2-approved 06/12/2011)~     .~   "
196847|NCT00986752|"~     The purpose of the study is to evaluate the efficacy of stenting after dilation with or~     without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral~     artery disease.~   "
196848|NCT00986739|"~     The aim of this multicenter study is to investigate risk factors for unplanned~     hospitalizations, including individual and environmental factors, notably air pollution.~   "
196849|NCT00986713|"~     The purpose of this study is to determine whether inhalation with aerosolized amphoterin B~     10mg/d is more effective than aerosolized amphoterin B 2mg/d to reduce the incidence of~     invasive pulmonary aspergillosis.~   "
196850|NCT00986700|"~     High fasting glucose is a very common problem in type 2 diabetic patients. The cause is~     probably glucose production by the liver, known as the dawn phenomenon. The investigators~     hypothesize that a late night meal can lower the fasting glucose level by early morning~     insulin secretion stimulated by the food. In this study the investigators intend to test the~     effect of different kinds of late night meals on fasting glucose in type 2 diabetic patients.~   "
196883|NCT00986245|"~     1. In order to compare the benefit, side effects, and patient preference of Ropinirole~          prolonged release when used in once-daily or twice-daily dosing~        2. In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged~          release~   "
196851|NCT00986687|"~     Vitrification is a method to cryopreserve biological specimens that are sensitive to chilling~     injury such as oocytes and embryos, and it has been employed with increased survival rate and~     live births (Hong et al., 1999; Kuleshova et al., 1999; Yoon et al., 2000; Chung et al 2000;~     Wu et al., 2001: Kuwayama et al 2006). In their study the researchers propose to directly~     compare oocyte survival, fertilizaton and embryo development between sibling oocytes.~      The Cryotop method of vitrification, which the researchers aim to investigate in their study,~     has been reported as the most efficient method for human oocytes cryopreservation (Kuwayama~     et al, 2005, Antinori et al, 2006, Lucena et al, 2006, Cobo et al, 2008). Follow up of over~     200 infants conceived from vitrified oocytes (Chian et al, 2008) indicate that the mean birth~     weight and the incidence of congenital anomalies are comparable to that of spontaneous~     conceptions in fertile women or infertile women undergoing IVF treatment.~   "
196852|NCT00986674|"~     This randomized phase II trial is studying how well giving carboplatin and paclitaxel~     together with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stage~     IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin~     and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and~     cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill~     more tumor cells. It is not yet known whether carboplatin and paclitaxel are more effective~     when given with cetuximab and/or cixutumumab in treating non-small cell lung cancer.~   "
196853|NCT00986661|"~     This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on~     tumor growth following a single intralesional injection of PV-10 in subjects with either (a)~     hepatocellular carcinoma (HCC) that is not amenable to resection, transplant or other~     potentially curative therapy or (b) cancer metastatic to the liver.~   "
196854|NCT00986648|"~     The PALF study group began with 20 sites and now continues with 12 sites (11 in the United~     States and 1 in Canada) in the new funding period. The primary objective of the Pediatric~     Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical,~     epidemiological, and outcome data in children with ALF, including information derived from~     biospecimens.~   "
196855|NCT00986635|"~     Rivaroxaban represent a new class of anticoagulation agents. As an oral direct factor Xa~     inhibitor it has been effective in preventing venous thromboembolism in patients undergoing~     elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo~     effects of Xarelto® on different coagulation parameters.~   "
196856|NCT00986609|"~     RATIONALE:~      Vaccines made from peptides may help the body build an effective immune response to kill~     tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or~     delay the recurrence of cancer.~      PURPOSE:~      To evaluate the efficacy of poly-ICLC + MUCI peptide vaccine in boosting the immunologic~     response to MUCI in patients with triple-negative BC~   "
196857|NCT00986596|"~     The purpose of the study is to investigate the effect of vitamin D on muscle tissue and~     physical performance.~   "
196858|NCT00986583|"~     Based on available mechanistic and clinical information, the investigators propose a~     nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The~     investigators' purpose is to evaluate the effect of succinylcholine on patients taking~     statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal,~     vascular or muscle) with planned endotracheal intubation will be approached regarding~     participation in the trial. Design of the study is complex because there is no way to~     randomize patients to statins or no statins and also no way to take them off the statins~     prior surgery. So statin use will not be randomized; confounding factors will be accounted~     for by stratification (every 10 years of age from 40-80 and gender) and statistical~     adjustment. The investigators propose to test the hypothesis that succinylcholine~     administration increases plasma myoglobin concentration more in patients who are on statins~     compared to patients who do not.~   "
196859|NCT00986570|"~     The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe,~     effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or~     severe expression lines (wrinkles) in the upper third of the face. The main outcome was the~     change in appearance of the wrinkles two weeks (visit 3) after product application as~     compared with baseline assessment.~   "
196860|NCT00986557|"~     RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce~     cytomegalovirus infection during the first year after a donor stem cell transplant.~      PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it~     works compared with standard therapy in treating patients at risk of cytomegalovirus~     infection after a donor stem cell transplant.~   "
196861|NCT00986544|"~     The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.~   "
196862|NCT00986531|"~     The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral~     probes of attention, working memory and affective reactivity in patients with schizophrenia.~   "
196863|NCT00986518|"~     T regulatory lymphocytes were shown to be partly responsible for immune tolerance to cancer~     cells. In that respect these cells oppose to the mounting of an efficacious immune response~     needed to cure cancer. To treat advanced metastatic colorectal cancer, the investigators~     propose an immunotherapy consisting in autologous lymphocytes infusion depleted from~     T-regulatory cells, associated with a 5-day prior lymphoid-ablative chemotherapy associating~     cyclophosphamide (day 1 & 2) with fludarabine (day 1 to 5). To administer treatment and~     monitor chemotherapy safety, patients will be hospitalized for 3 weeks until complete~     recovery from chemotherapy. Patients will then be followed-up ambulatory for 9 months during~     which time they will be assessed for tumor size with computed tomography (CT) - scan (primary~     criteria).~   "
196864|NCT00986505|"~     The effect of intravenous lidocaine infusion on manifestations of fibromyalgia manifestations~     were recorded before and 4 weeks after treatment. Pain intensity was rated on a numerical~     scale.The combination of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline~     for 4 weeks did not modify pain intensity or manifestations in patients with fibromyalgia.~   "
196867|NCT00986466|"~     The aim of the study is to investigate the effects of exercise and vitamin D supplementation~     on reducing falls and injuries in community-dwelling, independent-living women aged 70-79~     years of age. The investigators will test the following hypothesis:~        1. Exercise including strength, balance and mobility training will improve muscle~          functioning and body balance, and thus reduce falls by 30% compared with non-exercisers.~        2. Vitamin D intake will improve muscle functioning and thus prevent falls by 30% compared~          with placebo.~        3. Together vitamin D and exercise have a stronger influence on fall prevention than either~          used alone.~        4. Training improves mobility functions and bone health.~        5. Supervised training twice a week with daily home training will improve physical~          functioning thus resulting in reduced fear of falling.~        6. Reduced fear of falling and improved physical functioning help older people to stay~          physically active, which further improve their quality of life.~   "
196868|NCT00986453|"~     The objective of this clinical study is to evaluate the operative performance of the PEAK~     PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain,~     adverse events and skin scarring following surgery; and compare these outcomes to the current~     standard of care (SOC).~   "
196869|NCT00986440|"~     Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who~     achieved an objective response of Disease Control on first line therapy with Folinic acid~     (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid~     (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.~   "
196870|NCT00986427|"~     This purpose of this study is to assess the safety and effectiveness of Restasis® ophthalmic~     emulsion versus emulsion alone( Refresh Dry Eye therapy) both for the treatment of brittle~     nails and for the enhancement of normal nail growth and texture. The investigators think that~     daily application of Restasis® to nails and nail beds in patients with brittle nails will~     enhance nail growth and improve nail texture in both affected and unaffected nails.~   "
196871|NCT00986414|"~     This phase IIb study is designed to determine the safe and efficacious dose or dose range of~     AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa~     induced dyskinesias.~   "
196872|NCT00986401|"~     The purpose of this study is to investigate the safety and tolerability of trospium chloride~     (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered.~   "
196873|NCT00986375|"~     The purpose of this study is to help Internet users to adopt and maintain a healthy~     lifestyle, it is imperative to increase self-management competencies to improve healthy~     eating and regular physical activity. Aim of this research project is to evaluate an~     evidence- and theory-based computerized expert system in comparison to a standard program. In~     addition, two different tailoring criteria are compared to each other with regard to the~     misclassification of study participants. Internet users will be treated psychologically and~     followed up over 12 weeks. The computerized expert system is expected to help users better~     than the standard program. Both interventions are hypothesized to improve self-management~     competencies over time.~   "
196874|NCT00986362|"~     To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to~     conventional vitrectomy for the treatment of pediatric patients.~   "
196875|NCT00986349|"~     The main objective of the study is to demonstrate the safety and efficacy of the~     Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2~     diabetes.~   "
196876|NCT00986336|"~     The purpose of this study is to assess the potential pharmacokinetic (absorption,~     distribution and excretion of the drug by the body) interaction between, and the safety of,~     topiramate and risperidone administered in combination in patients with a history of either~     bipolar spectrum or schizoaffective (bipolar type) disorders as defined by DSM-IV criteria.~   "
196877|NCT00986323|"~     The purpose of this study is to determine whether nocturnal environmental control with~     Temperature controlled Laminar Airflow (TLA) is effective as add on treatment in patients~     with perennial allergic asthma.~   "
196878|NCT00986310|"~     The purpose of this study is to determine the effects of fluoxetine on breathing mechanisms~     during seizures. Patients with partial epilepsy commonly have changes in their breathing~     mechanisms during seizures. These changes may increase the risk of serious side effects from~     seizures, including sudden unexplained death in epilepsy (SUDEP), which affects 2-10 per 1000~     patients with epilepsy each year. Fluoxetine (Prozac) may help to stimulate breathing through~     its actions in the brain and has been shown to improve breathing changes seen with seizures~     in certain animals. Fluoxetine is in a class of medications called selective serotonin~     reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural~     substance in the brain, at synapses, the junctions at which nerve cells in the brain~     communicate. Fluoxetine is currently approved by the United States Food and Drug~     Administration (FDA) for the treatment of patients with Major Depressive Disorder, Obsessive~     Compulsive Disorder, Bulimia Nervosa, Panic Disorder and Premenstrual Dysphoric Disorder.~   "
196879|NCT00986297|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of specialized~     radiation therapy in treating patients with stage II, stage III, stage IV, or recurrent~     non-small cell lung cancer and poor performance status.~   "
196880|NCT00986284|"~     This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in~     stage IIIA NSCLC patients.~   "
196881|NCT00986271|"~     To investigate whether extravascular lung water index (EVLI) is an independent predictor for~     multiorgan dysfunction syndrome (MODS) in patients with severe sepsis and to determine if~     increased EVLI may serve as an predictor for MODS and mortality in those patients.~   "
196882|NCT00986258|"~     The main objective of the study is to evaluate the effectiveness, tolerability, and safety of~     tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back~     pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This is a~     clinical effectiveness trial designed to establish a link between anticipated clinical~     outcomes and the clinical practice by means of selected measures of clinical and~     subject-reported outcome.~      The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with~     that of tapentadol hydrochloride prolonged release treatment during defined periods of~     evaluation.~   "
196889|NCT00986167|"~     This study is a multi-site study examining the use of Quetiapine XR for psychotic aggression~     in an acute psychiatric setting. The study aims to demonstrate that management with~     Quetiapine XR significantly reduces aggressive behaviour in acute patients with psychosis,~     significantly reduces psychotic symptoms and decreases the requirement for sedation using~     benzodiazepines.~   "
196890|NCT00986154|"~     Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing~     recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the~     legs and/or blood clots in the lungs.~   "
196891|NCT00986141|"~     Primary objective is to evaluate the effect of selective laser trabeculoplasty (SLT) on the~     diurnal intraocular pressure variation in open-angle glaucoma patients (OAG).~   "
196892|NCT00986128|"~     The purpose of this study is to determine the initial (after 1-week of maintenance dosing)~     and extended (after 3-weeks of maintenance dosing) effect of topiramate, at doses up to 600~     mg/day, on the steady-state pharmacokinetics (absorption, distribution and excretion of the~     drug by the body) of lithium carbonate in patients with bipolar disorders.~   "
196893|NCT00986115|"~     People with epilepsy often experience problems with their memories and other thinking skills~     that get worse over time. The investigators hope to learn more about whether a drug called~     memantine can help improve or stabilize (keep the same) memory and other thought processes in~     people with epilepsy by blocking a chemical that is released in the brain during seizures.~     The investigators also want to see if memantine changes the frequency (how often) people with~     epilepsy have seizures. Memantine is currently approved by the United States Food and Drug~     Administration (FDA) for treatment of patients with Alzheimer's disease.~   "
196894|NCT00986102|"~     The purpose of this study is to understand the utilization patterns of doripenem in Asia~     Pacific, including the profile of the patients treated with carbapenems.~   "
196895|NCT00986089|"~     To evaluate the continuation of the Copper IUD at one year after placement through the~     cesarean incision into the uterus at the time of cesarean section.~   "
196896|NCT00986076|"~     The purpose of this study is to determine if intraocular infusion of low-molecular weight~     heparin (enoxaparin) influences postoperative inflammation following pediatric cataract~     surgery with intraocular lens (IOL) implantation.~   "
196897|NCT00986063|"~     Genetic tests has been suggested to reduce side effects related to Nevirapine(NVP), a~     commonly prescribed component of highly active antiretroviral therapy(HAART) in developing~     countries. This clinical trials is designed to determine the efficacy and the~     cost-effectiveness of this approach in the developing countries setting.~      NVP-based HAART and efavirenz(EFV)-based HAART will be provided through Thai national~     universal health coverage. Information of the prescribed drug will be collected, and~     monitoring for the compliance with the prescribed highly active antiretroviral therapy will~     be conducted.~      Outcome measurements:~      The primary objective of this study is to evaluate the reduction in incidences of NVP~     associated cutaneous side effects by genotype based personalized prescription. The volunteers~     will be monitored for any solicited and non-solicited adverse effects for 6 months after drug~     administration, with first 6 weeks intensive monitoring for cutaneous adverse reactions.~     Laboratory safety profiles (Complete Blood Count(CBC), Alanine transaminase(ALT), Aspartate~     transaminase(AST), Blood Urea Nitrogen(BUN), creatinine, direct bilirubin, total bilirubin,~     lactate dehydrogenase, alkaline phosphatase) will be assessed during the intensive monitoring~     period (6 weeks).~      Statistical Methods:~      Descriptive statistics will be used to evaluate the conduct of the study. Analysis variables~     will include overall follow-up rate, drug compliance, and events of protocol violation.~      Laboratory and safety data will be presented using comparative statistics for each study~     group and compared within and between groups using standard parametric or non-parametric~     comparison tests, i.e., McNemar's test or paired t-test as appropriate.~      Comparison of rate of cutaneous adverse reaction, hepatitis and severe cutaneous adverse~     reaction(SCAR) will be made with chi-square test. Variable that shown significant different~     between the standard of care or control group and the genetic test or intervention group~     will adjusted for the final analysis with Poisson logistic regression.~      The overall rate of adverse events in all participants will be monitored whether the rate of~     adverse events is lower than the predefined criteria. The extension of trial may be~     considered based on the rate of adverse events.~   "
196898|NCT00986050|"~     The DEBATER study is designed to determine the superiority of abciximab over no abciximab and~     to determine the superiority of drug eluting stents over bare metal stents in patients with~     acute myocardial infarction who undergo percutaneous coronary intervention.~   "
196899|NCT00986037|"~     The primary purpose of this study is to determine the safety, tolerability and~     pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate~     controlled asthma.~   "
196900|NCT00986024|"~     The aim of the present study was to evaluate the effects of aerobic interval training versus~     strength training or a combination of these regimes on factors comprising the metabolic~     syndrome in order to find the most effective exercise regime for patients with metabolic~     syndrome.~   "
196901|NCT00986011|"~     RATIONALE: Overweight and obesity have been associated with multiple types of disease,~     including cancer. Living in a smart growth community may encourage behaviors that would~     reduce the risk of obesity.~      PURPOSE: This research study is looking at the effect of a smart growth community on~     prevention of obesity in middle-, moderately low- and low-income families.~   "
196902|NCT00985998|"~     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located~     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical~     efficacy has been shown in adult with head and neck cancer. The study assessed the safety,~     and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy~     in patients with advanced non-small cell lung cancer (NSCLC).~   "
196903|NCT00985985|"~     A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to~     evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult~     cigarette smokers who are motivated to quit smoking. Successful quitters or participants who~     smoke occasionally will be followed up after week 24 till 12 months.~   "
196914|NCT00985842|"~     Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance~     phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual~     limb and occlude blood flow. This occlusion can be relieved during swing phase, but may~     depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the~     range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees~     during gait and (2) to learn which of five different prosthetic limb systems provides greater~     tissue oxygenation.~   "
196915|NCT00985829|"~     The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors~     that affect response rate.~   "
196916|NCT00985816|"~     The investigators propose a Phase II interventional trial to investigate the role of~     Lactobacillus reuteri DSM 17938 on the intestinal motility and immune response of premature~     infants and further evaluate safety of the use of this probiotic in a population of premature~     infants.~   "
196904|NCT00985972|"~     The aim of this study focuses on obtaining accurate information on the effectiveness of~     interventions involving physical activity and/or nutrition education developed in the school~     environment. This study is intended to assist in future assembly and development of effective~     school practices related to preventing and reducing levels of overweight in children and~     adolescents.~      Updated data from the systematic review:~      5,899 studies were retrieved in 14 databases (Assia, Central Cochrane, CINAHL, EMBASE, ERIC,~     ISI, LILACS, Physical Education Index, PsycINFO, PubMed, Social Care Online, Social Services~     Abstracts, Sociological Abstracts, SPORTDiscus)~      1,228 were excluded as duplicates by Eppi Reviewer~      4,678 studies referred for evaluation by title and abstracts (4,671 by systematic searches, 7~     by cross-references list)~      211 full text papers reviewed by EPHPP and GRADE tools~      140 studies with data extracted~      Body Mass Index Results:~        1. Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. The effect of school-based physical~          activity interventions on body mass index: a meta-analysis of randomized trials. Clinics~          (Sao Paulo). 2013 Sep;68(9):1263-1273 - Isolated Physical Activity interventions: 0.02~          (95%CI: -0.13, 0.17; 11 trials; n=4,273; I2=77%)~        2. Silveira JA, Taddei JA, Guerra PH, Nobre MR. The effect of participation in school-based~          nutrition education interventions on body mass index: a meta-analysis of randomized~          controlled community trials. Prev Med. 2013 Mar;56(3-4):237-43 - Isolated Nutrition~          Education interventions: -0.33 (95%CI: -0.55, -0.11; 8 trials; n=8,491; I2=95%)~        3. Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. School-based physical activity and~          nutritional education interventions on body mass index: a meta-analysis of randomized~          community trials - Project PANE (manuscript under review) - Combined Physical Activity~          and Nutrition Education interventions: -0.03 (-0.09, 0.04; 38 trials; n=28,870; I2=83%)~          / All interventions included: -0.03 (95%CI: -0.09, 0.03; 55 trials n=41,634; I2=87%)~   "
196905|NCT00985959|"~     The purpose of the study in Phase I is to select the recommended dose of bortezomib in~     combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess~     the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I~     portion).~   "
196906|NCT00985946|"~     This summary will use Panobinostat (LBH589) in patients with neuroendocrine tumors to see how~     the patient's tumor responds to panobinostat. Additionally, this study will examine how long~     it takes neuroendocrine tumor patient's cancer to progress while taking the drug and examine~     the overall survival of patients using panobinostat. Also, the study will examine the~     toxicity and tolerability of panobinostat in the patient population. Finally, this study will~     look at the effect of panobinostat on Notch 1 signaling before and after treatment with~     panobinostat.~   "
196907|NCT00985933|"~     The purpose of this study is to assess if ketamine will induce, in healthy volunteers,~     impairment of working memory and if the drug AZD8529 will block the effects of ketamine on~     working memory as assessed by functional magnetic resonance imaging (fMRI).~   "
196908|NCT00985920|"~     Total knee arthroplasty (TKA), the definitive treatment of osteoarthritis, is often~     associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the~     objective of the proposed study is to determine the role of topical application of tranexamic~     acid (TA), an anti-fibrinolytic agent, into the knee joint just before closure during TKA to~     reduce perioperative bleeding. The investigators' hypothesis is that in patients undergoing~     unilateral primary TKA, intraoperative application of 1.5 g or 3.0g topical TA into the knee~     joint before closure reduces perioperative bleeding as depicted by a decrement in the maximal~     drop in hemoglobin concentration following surgery. This proposal describes a randomized,~     double-blinded, placebo-controlled clinical trial with three arms. The primary outcome is the~     extent of the postoperative reduction in hemoglobin levels. Secondary outcomes will include~     transfusion requirements, hospital stay, joint functionality, quality of life and safety of~     using topical TA. Topical application of TA is a novel intraoperative approach that has not~     been used or studied in TKA. However if it is effective, it will directly reduce~     postoperative intra-articular bleeding without subsequent systemic absorption and~     thromboembolism. In addition, the reduction in microvascular intra-articular bleeding will~     lead to less pain and infection rates as well as improved surgical functional outcomes.~   "
196909|NCT00985907|"~     The median overall survival (OS) of relapsed/refractory multiple myeloma (MM) is less than~     nine months. However, phase II data with the proteasome inhibitor bortezomib (Velcade®) has~     been heartening, with 35% overall response rates and median survival of 16 months. In-vitro~     data has shown that this agent dramatically increases the sensitivity to chemotherapeutic~     agents. Liposomal doxorubicin (Doxil), melphalan, and bortezomib all have different~     mechanisms of action and toxicity profiles. Clinical studies employing two drug combinations~     with these agents in patients with refractory MM have found favorable efficacy (nearly no~     progression of disease) and tolerance data. Thus, the investigators are initiating a phase~     I/II study to examine the safety and efficacy of combining all three agents into the regimen~     DMV (Doxil® + melphalan + Velcade).~   "
196910|NCT00985894|"~     The purpose of this study is to determine if an asynchronous online model of teledermatology~     can achieve similar clinical outcomes as compared to conventional in-office care for the~     management of atopic dermatitis. The investigators also aim to determine the effects of this~     online care model on patient quality of life as well as patient and physician satisfaction.~      The investigators' hypotheses include the following:~        1. Compared to in-person visits, the online care model will result in similar clinical~          improvement in atopic dermatitis disease severity.~        2. Compared to in-person visits, the online care model will result in similar improvements~          in quality of life.~        3. Providers and subjects in the online group will achieve a similar level of overall~          satisfaction as those in the in-person group.~   "
196911|NCT00985881|"~     The purpose of this study is to determine if subthreshold vibration, when applied to the~     residual limb of a lower limb amputee through their prosthetic socket, can sufficiently~     enhance peripheral sensation to result in an improved ability to balance and walk.~   "
196912|NCT00985868|"~     RATIONALE: AT9283 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in children~     and adolescents with relapsed and refractory solid tumors.~   "
196913|NCT00985855|"~     Phase II, randomised, controlled, non comparative study with 2 parallel groups:~        -  Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed~          by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine~          associated with a weekly cetuximab infusion during the radiotherapy.~        -  Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed~          by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide~          associated with a weekly cetuximab infusion during the radiotherapy.~   "
196973|NCT00985075|"~     The objective of this study is to evaluate ocular and nasal signs and symptoms in patients~     with seasonal allergic rhinoconjunctivitis following allergen exposure in the Allergen~     BioCube.~   "
196917|NCT00985803|"~     The purpose of this study is to check the improvement in quality of life in patients with~     systemic lupus incorporated into a routine of physical activity.~      Randomized controlled blinded trial, 63 patients aged 42.9 ± 14.4 and diagnosis of systemic~     lupus erythematosus (SLE) according to the criteria of the College American Rheumatology,~     1997. After randomization patients were allocated into 3 groups, control group (CG) (n = 21),~     training cardiovascular (CT) (n = 20), resistance training (RT) (n = 22), performing 12 weeks~     of intervention with a frequency of three times weeks and were evaluated at two different~     times (T0 and T12). As primary outcome quality of life was assessed by the inventory Generic~     Assessment of quality of life by the Medical Outcomes Study 36 -- Healthy ItemShort Form~     Survey (SF36) and as secondary outcomes functional capacity evaluation of pain symptoms~     (visual scale analogue pain [VAS]), intensity of symptoms of depression (Beck Depression~     Inventory [BDI]), index of disease activity (Systemic Lupus Disease Activity Inventory~     Erythmatodud [SLEDAI]), capacity aerobic (walking test of 12 minutes [T12]), subjective~     perception effort (subjective scale of Borg [Borg]), limb muscle strength lower (analog~     dynamometer [strength]), electrical activity member lower (surface electromyography [EMG]),~     amount of products (inventory amount of Medicines).~   "
196918|NCT00985790|"~     The purpose of the present study is to assess the immunogenicity and safety of vaccine~     GSK2321138A in children.~   "
196919|NCT00985777|"~     The purpose of this study is to determine the safest dose of the study drug Vitamin E~     Delta-tocotrienol, how often it should be taken, and how well people with pancreatic tumors~     tolerate Vitamin E Delta-tocotrienol.~   "
196920|NCT00985764|"~     Effects of placenta previa on incidence and severity of venous air embolism in patients~     during cesarean delivery~   "
196921|NCT00985751|"~     This study will assess the safety, reactogenicity and immunogenicity of different~     formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in~     combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a~     2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23~     months at the time of first vaccination. Considering that febrile reactions are frequently~     observed following pneumococcal vaccination, usually co-administered with other routine~     paediatric vaccines, the primary study objective will focus on evaluating the increase in~     grade 3 fever (i.e. rectal temperature >40.0°C).~   "
196922|NCT00985738|"~     The purpose of this study is to determine the effect of short-term intake of daily~     Dutasteride in patients with prostate cancer.~   "
196923|NCT00985725|"~     To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI)~     when used as an adjunct to stable, standard therapy in the setting of partial or full~     remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive~     Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult~     Version (BRIEF-A).~   "
196924|NCT00985712|"~     The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory~     function, when used over 24 weeks for prandial insulin injections achieves superior glycemic~     control, when compared to the conventional HumaPen Luxura without memory function.~   "
196925|NCT00985699|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at genes in tissue samples from patients with B-cell~     non-Hodgkin lymphoma.~   "
196926|NCT00985686|"~     The purpose of this project is to explore the potential value and practicality of an~     innovative depression intervention for young people. More specifically, the objectives of~     this project are:~        1. to pilot the Internet-based Spirituality Program with depressed young people (age 13-24)~          in Calgary by:~             1. obtaining preliminary estimates on the impact of the program on the primary outcome~               of depression severity, and secondary outcomes of spiritual well-being and~               self-concept.~             2. obtaining preliminary estimates on response rates and remission rates to guide~               sample size estimations for a full size randomized trial.~             3. evaluating if the suggested research methodology is feasible with respect to~               recruitment rate, patient burden and clinical implementation to guide design of a~               full size randomized trial.~        2. to gather feedback from depressed young people, their families and referral sources in~          the community (schools, family physicians, mental health outpatient services) on the~          perceived value of the program and on ways to eventually make it available as a~          community resource for others dealing with depression.~   "
196927|NCT00985673|"~     The purpose of this study is to characterize the safety and immunogenicity of the H1N1~     (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu~     vaccine in adults 19 to 40 years of age.~   "
196928|NCT00985660|"~     The objective of this study was to investigate the bioequivalence of nisoldipine~     extended-release 30 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release~     30 mg tablet (manufactured for First Horizon) following a single, oral 30 mg (1 × 30 mg~     tablet) dose administration in healthy adult subjects under fasting conditions.~   "
196929|NCT00985647|"~     The purpose of the study is to measure the pharmacokinetics (how a drug is absorbed,~     distributed and eliminated from the body) of lamivudine (3TC) and its active component after~     3TC is given at two different doses, 300mg and 150mg once daily.~   "
196930|NCT00985634|"~     The primary purpose of this study is to demonstrate the clinical safety and efficacy of~     LeGoo™ in comparison to a standard vessel occlusion method (i.e. vessel loops). Although~     LeGoo™ is suitable for use in any vascular surgery where temporary vessel occlusion is~     desired, this study specifically focuses on the use of LeGoo™ in off-pump coronary bypass~     (OPCAB), as a most sensitive model of adverse changes that may occur at any vascular site.~   "
196931|NCT00985621|"~     The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared~     to oxycodone CR and placebo in patients with osteoarthritis~   "
196983|NCT00984945|"~     The primary objective is to assess the safety and tolerability of two consecutive doses of~     plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21~     days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined~     with Alhydrogel®.~   "
196932|NCT00985608|"~     H pylori gastric infection is one of the most prevalent infectious diseases worldwide. The~     discovery that most upper gastrointestinal diseases are related to H pylori infection and~     therefore can be treated with antibiotics is an important medical advance. Currently, a~     first-line triple therapy based on proton pump inhibitor (PPI) or ranitidine bismuth citrate~     (RBC) plus two antibiotics (clarithromycin and amoxicillin or nitroimidazole) is recommended~     by all consensus conferences and guidelines. Even with the correct use of this drug~     combination, infection can not be eradicated in up to 23% of patients. Therefore, several~     second line therapies have been recommended. A 7 d quadruple therapy based on PPI, bismuth,~     tetracycline and metronidazole is the more frequently accepted. However, with second-line~     therapy, bacterial eradication may fail in up to 40% of cases. When H pylori eradication is~     strictly indicated the choice of further treatment is controversial. When available,~     endoscopy with culture and consequent antibiotic susceptibility testing remains the most~     appropriate option for patients with two eradication failures to avoid a widespread use of~     expensive antibiotics. The use of these drugs may also induce severe side-effects and~     development of H pylori resistant strains.~      Resistant strains of Helicobacter pylori can display a dense biofilm with mucus and~     microorganisms in a coccoid shape on the mucosal surface of stomach that may have a role in~     determining the resistance to the antibiotic therapies. Possibly, N-acetil-cysteine (NAC) may~     dissolve biofilm architecture and help to eradicate resistant strains of H pylori.~   "
196933|NCT00985595|"~     The objective of the study is to test the effectiveness, implementation quality, and cost~     effectiveness of family-based treatment services for adolescent substance abuse delivered in~     an agency setting.~   "
196934|NCT00985582|"~     The aims of this study are to characterise the clinical efficacy and virological clearance~     dynamics of orally administered oseltamivir in patients with influenza caused by novel~     influenza A(H1N1). This research will also contribute to enhancing research capacity in~     affected countries.~      The objectives are to assess the:~        -  viral replication levels over time in affected patients~        -  antiviral efficacy of oral oseltamivir~        -  patterns and compartments of viral shedding, tissue distribution~        -  innate inflammatory response and relation to viral replication~        -  kinetics of antibody response~        -  antiviral sensitivity of influenza viruses at baseline and during oseltamivir treatment~          using in vitro and molecular methods~        -  pharmacokinetic characteristics of oseltamivir and oseltamivir carboxylate~        -  all cause in hospital mortality~        -  clinical and radiological features, disease course and outcome~        -  length of stay in hospital~        -  risk factors associated with development of severe disease and death~   "
196935|NCT00985569|"~     The purpose is to assess the efficacy, clinical outcomes, and potential Quality Indicator~     benefits associated with the use of Lubiprostone in nursing home residents with a confirmed~     diagnosis of chronic idiopathic constipation.~   "
196936|NCT00985556|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, S-1, and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. It is not yet known whether giving oxaliplatin together with S-1 is more effective~     than giving oxaliplatin together with capecitabine.~      PURPOSE: This randomized phase II trial is studying how well giving oxaliplatin together with~     S-1 works compared to oxaliplatin given together with capecitabine in treating patients with~     recurrent, metastatic, or unresectable gastric cancer.~   "
196937|NCT00985543|"~     The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir~     over a 12-hour dosing interval, following administration to male and female HIV−negative~     healthy volunteers of:~        1. Lopinavir/ritonavir 400/100 mg twice daily~        2. Lopinavir/ritonavir 200/150 mg twice daily~        3. Lopinavir/ritonavir 200/50 mg twice daily~   "
196938|NCT00985530|"~     Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial~     treatment or has not gone away with initial therapy. This research study involves testing an~     investigational drug called Tamibarotene in combination with standard treatment for relapsed~     APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with~     relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans~     retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA~     and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia~     cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of~     this study is to determine if tamibarotene in combination with arsenic trioxide is safe and~     effective.~   "
196939|NCT00985517|"~     The purpose of this study is to evaluate the safety and potential benefits of CERE-120 in the~     treatment of Parkinson's disease. CERE-120 is an experimental drug that consists of an~     adeno-associated virus (AAV) that was engineered to carry the human gene for neurturin, a~     neurotrophic (growth) factor. Similar to other growth factors (such as GDNF), neurturin is~     capable of restoring function and protecting brain cells from further damage. The virus used~     in CERE-120 is not known to cause disease in people.~      CERE-120 is delivered directly to the brain cells most affected in Parkinson's disease - the~     dopamine producing neurons. CERE-120 is injected during brain surgery. Once in place,~     CERE-120 continuously produces neurturin.~   "
196940|NCT00985504|"~     The purpose of this study is to provide a comparison of the apathy, depression, and~     functional outcomes associated with switching to duloxetine or escitalopram in patients who~     have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI)~     for major depressive disorder and who have residual apathy in the absence of depressed mood.~   "
196941|NCT00985491|"~     The purpose of this study is to determine whether the GI Endobarrier Liner is safe and~     effective.~   "
196942|NCT00985478|"~     First in man study with single and multiple rising doses with SLV342~   "
196943|NCT00985465|"~     The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK~     Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster~     dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects~     previously enrolled in the primary vaccination study NCT00678301.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00678301).~   "
196944|NCT00985452|"~     The investigators hypothesize that providing subjects on a once-a-day hypertension medication~     with GlowCaps ConnectTM will lead to an improvement in their medication adherence. The~     investigators propose to conduct a 6-month randomized control trial to assess the effect of~     the GlowCaps Connect™ system on the enhancement of hypertension medication adherence among~     subjects with a diagnosis of hypertension recruited from the greater Boston area. 130~     subjects will be enrolled. Subjects will be randomized into either the control group or into~     one of two intervention groups.~   "
196945|NCT00985439|"~     The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are~     safe and effective for the treatment of dental pain.~   "
196946|NCT00985426|"~     The purpose of the study is to explore the safety and immunogenicity of a new investigational~     hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive~     loss of kidney function.~   "
196947|NCT00985413|"~     This is an Observational Study of children under the age of 11 diagnosed with Cockayne~     Syndrome to assess the natural progression of Cockayne Syndrome disease, with special~     attention to hearing and physical changes in length or height, weight, head circumference,~     and arm span during standard treatment.~      The primary analytical objective is to determine the rate of linear growth over a 6-month~     period in children < 2 years of age and over a 12-month period in children ≥ 2 years of age.~   "
196948|NCT00985400|"~     The goal of this study is to compare the effects of exercise with the effects of relaxation~     training on physical function (how well participants perform normal daily activities) and~     symptoms related to your cancer diagnosis (such as tiredness, pain, and nausea).~   "
196949|NCT00985387|"~     The purpose of the study is to assess patient's persistency in maintaining solifenacin~     treatment for overactive bladder.~   "
196950|NCT00985374|"~     This 2 part study will assess the safety, tolerability and efficacy of a combination of oral~     daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1~     of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001~     daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po~     RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with~     1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive~     the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507).~     The anticipated time on study treatment is until disease progression, and the target sample~     size is 100-500 individuals.~   "
196951|NCT00985361|"~     The purpose of this study is to determine if daily supplementation with 2000 International~     Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.~   "
196952|NCT00985348|"~     To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus~     Levetiracetam 500 mg oral tablet, used as reference, after single dose administration in~     healthy Japanese subjects.~   "
196953|NCT00985335|"~     This study intends to test the efficacy of the TheraNeem Lip Therapy balm for Herpes Simplex.~     The study will include a total of 5 people.~   "
196954|NCT00985322|"~     Background: Angiotensin-converting-enzyme (ACE) inhibitors have a specific cardioprotective~     effect and, compared to treatment not directly interfering with the renin-angiotensin-system~     (RAS), significantly reduce cardiovascular (CV) mortality and morbidity in subjects with~     normal renal function.~      Despite CV events are the leading cause of death in these patients, no adequately powered~     trial so far evaluated the specific cardioprotective effect of ACE inhibitors in this~     population.~      Objectives: This prospective, randomized, open label, blinded end point (PROBE) trial is~     primarily aimed at evaluating whether, at comparable blood pressure (BP) control, ACE~     inhibitor as compared to non-RAS inhibitor therapy significantly reduces the incidence of a~     composite end point of CV death (including sudden death) and non-fatal myocardial infarction~     or stroke in 624 patients with arterial hypertension (pre-dialysis systolic/diastolic BP~     >140/90 mmHg or post-dialysis systolic/diastolic BP >130/80 mmHg or antihypertensive therapy)~     and/or echocardiography evidence of LVH (cardiac mass index >130 g/m2 for men and 100 g/m2~     for women) who are on dialysis therapy since at least six months. Secondarily, the study will~     compare the incidence of single components of the primary outcome, new onset paroxysmal or~     persistent atrial fibrillation, thrombosis of the artero-venous fistula, new onset,~     progression or regression of LVH, changes in components of the metabolic syndrome, the safety~     profile of the two treatment regimens and their cost/effectiveness.~      Methods: After 1 month wash-out period from previous RAS inhibitor therapy and a baseline~     evaluation of main clinical and laboratory parameters, patients will be randomized on a 1:1~     basis to 2-year treatment with an ACE inhibitor or a BP lowering regiment not including RAS~     inhibitors. A balanced distribution according to centre, number of dialysis sessions per week~     (2 or 3), presence of diabetes (YES/NO), arterial hypertension (YES/NO), LVH (YES/NO) will be~     achieved by the minimization method. Treatment will be adjusted to achieve and maintain a~     target BP <140/90 mmHg (pre-dialysis) and a target BP <130/80 mmHg (post-dialysis) in both~     groups.~      Expected results: ACE inhibitor compared to non-RAS inhibitor therapy is expected to reduce~     more effectively fatal and non-fatal CV events, prevent or limit progression or induce~     regression of LVH, improve some components of the metabolic syndrome, and reduce treatment~     costs for cardiovascular complications. These findings might help achieving more effective~     cardioprotection in people on chronic dialysis at lower costs.~   "
196955|NCT00985309|"~     According the terminology of Bethesda 2001, the unsatisfactory cervical cytology can be~     categorized into specimen rejected, or specimen processed and examined, but unsatisfactory~     for evaluation of epithelial abnormality. Most of the unsatisfactory cervical cytology was~     due to scanty epithelial cells, which was defined by less than an estimated 8,000 to 12,000~     well-visualized squamous cells for conventional smears. Follow-up of unsatisfactory smear~     found an increased rate of cervical preinvasive and invasive lesions. Thus, an unsatisfactory~     smear deserves careful follow-up and studies. Although the Bethesda system allows criteria~     modification in cases of hysterectomy, pelvic irradiation therapy, or chemotherapy, no~     studies investigated the clinical factors related to the incidence of unsatisfactory smear.~     Thus, the investigators designed this trial to study the clinical factors relating to~     unsatisfactory cervicovaginal smear.The list of patients who received Papanicolaou smear~     between March 2006 and August 2006 in our hospital will be obtained from the Pathological~     Department first. Then the investigators will review the medical records from HIS system and~     pathologic files of these patients. On estimation, 7,437 cases will be enrolled for analysis.~     Clinical parameters for analysis include: age, gravidity, parity, abortion, menopause,~     location of Pap smear, history of pelvic malignancy, pelvic irradiation, cervical conization,~     hysterectomy; at pregnancy; three months postpartum; vaginal bleeding, vaginal abnormal~     discharge, intrauterine device, and cervical polyp found during pelvic examinations. Patients~     who missed any of above data will be excluded for analysis. The investigators will use~     univariate and multivariate analysis for data processing and statistic analysis to find out~     the relationship between clinical parameters and unsatisfactory cervicovaginal Pap smears.~   "
196956|NCT00985296|"~     To evaluate the effect of Conjunctival Allergen Challenge (CAC) with Dust Mites on nasal and~     ocular allergic symptoms following allergen exposure in the Allergen BioCube (ABC).~   "
196957|NCT00985283|"~     The goals of this project are to implement an innovative intervention for older adults and~     assess both its feasibility and effects on health and well-being. The investigators~     hypothesize that the intervention group will show a significantly better slope for a range of~     outcomes during and after the intervention.~   "
196984|NCT00984932|"~     Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the~     initial event and statins through their vasculoprotective effect might be of value in the~     treatment armamentarium of PAH related to SSc.~      The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and~     in the management of SSc-related PAH.~   "
196958|NCT00985270|"~     This clinical trial is designed to study the effects of rifampicin on the glucose, lipid and~     hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin lowers~     fasting glucose and enhances insulin sensitivity. The study is a randomized,~     placebo-controlled, open-label cross-over trial. Twelve subjects will be given 600 mg of~     rifampicin a day for a week compared to a one-week placebo arm. There is at least a 4-week~     wash-out between the arms. The main outcome measures are the changes in the fasting glucose~     and HOMA-IR-index (calculated based on fasting glucose and insulin).~   "
196959|NCT00985257|"~     The purpose of this study is to evaluate the performance of a new blood glucose meter in the~     hands of children, teens, young adults.~   "
196960|NCT00985244|"~     To assess whether maintenance treatment with macrolide antibiotics in COPD patients with~     three or more exacerbations in the preceding year of inclusion can decrease the exacerbation~     rate in the year of treatment.~   "
196961|NCT00985231|"~     This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses~     compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens~     wearers on a daily wear basis.~   "
196962|NCT00985218|"~     The purpose of this study is to compare the development of human embryos grown in a~     conventional culture dish to those grown in a new embryo culture device known as the SMART~     System.~   "
196963|NCT00985205|"~     The purpose of this study is to test the following hypotheses:~        1. Enteral glutamine administration decreases in-hospital mortality in adult patients with~          severe thermal burn injuries.~        2. Enteral glutamine administration decreases hospital-acquired blood stream infections~          from Gram negative organisms and length of stay in ICU and hospital for adult patients~          with severe thermal burn injuries.~        3. Enteral glutamine administration will improve the physical function of surviving burn~          injured patients and reduce their cost of care.~      The objectives of this trial are to determine the overall treatment effect and safety of~     glutamine in burn patients. Specifically, the investigators want to assess the following~     outcomes in a sample of 2,700 patients in 80 sites:~        1. In patients with severe, life-threatening burn injury, what is the effect of enteral~          glutamine on 6 month mortality?~        2. In patients with severe, life-threatening burn injury, what is the effect of enteral~          glutamine on time to discharge alive from hospital, hospital-acquired blood stream~          infections from Gram negative organisms, hospital mortality, duration of stay in ICU and~          hospital, health-related quality of life, and health care resources?~   "
196964|NCT00985192|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with~     previously treated unresectable or metastatic esophageal cancer or stomach cancer.~   "
196965|NCT00985179|"~     To help employees to adopt and maintain a healthy lifestyle, it is imperative to increase~     their self-management competencies. Aim of this research project is to evaluate an evidence-~     and theory-based computerized expert system in comparison to waiting control group. Employees~     will be treated psychologically and followed up over 18 months. The computerized expert~     system is expected to help employees significantly changing their lifestyle. The intervention~     is hypothesized to improve self-management competencies over and above the regular check-up~     at their medical appointment (i.e., waiting control group).~   "
196966|NCT00985166|"~     The study was conducted to determine if ProQuad may be used in place of the second dose of~     M-M-R II routinely given to children 4 to 6 years old who were previously immunized with~     M-M-R II and Varivax.~   "
196967|NCT00985153|"~     This study will compare three consistency lots of ProQuad to each other as well as to M-M-R~     II and Varivax, administered concomitantly at different injection sites, with respect to~     immunogenicity, safety, and tolerability.~   "
196968|NCT00985140|"~     To examine the efficacy and safety of total skin electron beam therapy to a dose of 12 Gray~     (TSEBT 12 Gy) in patients who have mycosis fungoides (MF) staged as IB to IIIA.~   "
196969|NCT00985127|"~     The study will be conducted in two parts. The first is a parallel-group design, evaluating~     doses of 40 mg, 80 mg or 120 mg BCX-4208. The second part is planned as a dose-escalation~     study, evaluating higher doses including 160 mg, 240 mg and 320 mg BCX-4208. The study's~     primary endpoint is the change in uric acid in the blood compared to baseline measurement~     prior to treatment, assessed on Day 22.~   "
196970|NCT00985114|"~     The purpose of this study is to evaluate the safety and efficacy of a second generation~     EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.~      This is a randomized, controlled study which will enroll approximately 70 Subjects with Type~     2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device~     Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will~     be offered the EndoBarrier device after 12 months on study at the investigator's discretion~     if treatment of the device subjects indicates adequate efficacy. This study will be conducted~     at three (3) investigational sites.~      The primary efficacy endpoint is:~        -  Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24~          weeks or last visit from baseline between the two groups.~      Secondary endpoints are:~        -  Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit~          from baseline.~        -  Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or~          discontinued at week 24 or last visit from baseline.~        -  Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced~          by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from~          baseline.~        -  Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.~        -  Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12~          months.~        -  Compare physical component summary (PCS), mental component summary (MCS) and quality~          adjusted life years (QALYs)via analysis of the SF-36v2 QOL.~   "
196971|NCT00985101|"~     The purpose of this study is to examine if an early detectable dysfunction in a cellular~     component (mitochondria) may predict complications in diabetes mellitus.~   "
196972|NCT00985088|"~     The purpose of this study is to characterize the safety and immunogenicity of the H1N1~     (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.~      This protocol posting has been updated for sections impacted by the Protocol amendment 1,~     Sept 2009.~   "
196974|NCT00985062|"~     In vitro fertilization (IVF) is an assisted reproductive technique to achieve pregnancy in~     subfertile couples of which the average success rate is only 25%. Mild ovarian stimulation~     treatment yields less oocytes, has less adverse effects but has a comparable clinical outcome~     compared to conventional stimulation treatment. There is high inter- and intra person~     variability in ovarian response and fertility outcome parameters after stimulation treatment~     and little is known about explanatory variables herefore.~      Nutrition and in particular folate, or its synthetic derivative folic acid, is a B-vitamin~     which has been widely asssociated with reproductive outcome and subfertility. Therefore, in~     this study we aim to investigate the influence of preconception nutrition and folic acid use~     on ovarian response after mild/conventional stimulation treatment and to identify biomarkers~     in the follicular fluid which can indicate oocyte quality and other fertility outcomes.~   "
196975|NCT00985049|"~     Hypothesis: The investigators hypothesize that genetic variants will alter gene expression in~     response to ischemia during cardiopulmonary bypass. To test this, the investigators will be~     taking small pieces of heart tissue from patients undergoing heart surgery before and after~     this period of ischemia. This will be compared to blood gene expression in blood cells and~     analyzed with the patients' genetic profile. This might allow us to assess the amount of~     inflammation that occurs when patients are on the heart-lung machine as well as examine the~     effects genes have on this critical time period.~   "
196976|NCT00985036|"~     Objectives: This study is looking at the level of vascular endothelial growth factor (VEGF)~     circulating in the blood stream of patients diagnosed with either a meningioma or a glioma.~     The questions that will be addressed include:~        1. Can VEGF level alert us to tumor progression or recurrence before MRI changes occur?~        2. Is the VEGF level an indicator of the response to treatment?~        3. Does the VEGF level correlate with tumor histology and behavior?~        4. Is there a relationship between VEGF level and outcome?~   "
196977|NCT00985023|"~     The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion~     of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of~     motion and shape to the foot. In certain foot fractures where the Lisfranc ligaments are~     damaged, the constraint and stability it had given to the middle of the foot is lost.~     Attempted activity at the foot will result in pain and abnormal motion. If injury to the~     Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and~     deformity.~      The current standard orthopaedic treatment of foot fractures with Lisfranc ligament injuries~     is surgery. The foot fractures are fixed with metal screws. The Lisfranc ligaments are fixed~     by compressing the space between the middle bones of the foot with steel screws. These screws~     allow for ligament healing. As the ligaments heal, the patient should not resume activity~     with the fixed foot too soon as the screw may break. Upon breakage, the ligament repair may~     fail and the screw is now difficult to surgically remove. Regardless of breakage, a second~     surgical procedure is often recommended to remove the steel screw 6 months after foot~     surgery. This allows for a complete return of normal foot range of motion, but at the cost of~     a second surgical procedure.~      The investigators hypothesize that absorbable screw fixation of the Lisfranc ligaments does~     not yield significant differences in postoperative foot stability, ligament function, and~     symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the~     Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw~     is not necessary.~   "
196978|NCT00985010|"~     Objective:~      Report manganese serum levels and mortality in encephalopathic patients.~      Patients and participants:~      Consecutive patients aged > 18 years, with hepatic encephalopathy and informed consent signed~     by their families.~      Interventions:~      Patients' clinical characteristics as well as biochemical tests of renal function,~     hemoglobin, glucose and albumin levels were obtained as well as a blood sample to analyze~     manganese levels with a graphite furnace atomic absorption spectrometer.~      Hypothesis:~      There is a difference in the manganese levels between male and female patients.~   "
196979|NCT00984997|"~     1. To determine the outcome of patients with potentially resectable superior sulcus tumors~          of non-small cell histology treated by surgery followed by accelerated radiation therapy~          and chemotherapy.~        2. To evaluate toxicity, the initial local-regional control rate, sites of and time to~          local and distant failures.~   "
196980|NCT00984984|"~     The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has~     not been proved. French neurologists treat such patients with intravenous corticosteroids.~     The aim of the study is to check if the efficacy of high dose oral methylprednisolone is~     similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is~     symptom recovery within 28 days after inclusion.~   "
196981|NCT00984971|"~     To date, the majority of microbicide research has focused on the assessment of the safety and~     effectiveness of vaginal microbicides used for the prevention of HIV transmission via the~     vaginal compartment. Receptive anal intercourse (RAI) is common among men who have sex with~     men (MSM), and there is increasing evidence that heterosexual women in the developed and~     developing world also practice anal sex. It can, therefore, be anticipated that once vaginal~     microbicides are licensed, they will be used in both the vaginal and rectal compartments. As~     a consequence, there is a need to evaluate both the rectal and vaginal safety profile of~     candidate microbicides. Therefore, the primary objective of this study is to evaluate the~     systemic safety of 1% vaginally formulated tenofovir gel applied rectally. In addition, this~     study will evaluate the immunotoxicity of the gel and evaluate its acceptability; it will~     also use the oral tenofovir disoproxil fumarate tablets (TDF), rectally-applied tenofovir~     gel,and a placebo gel to compare their systemic and compartmental pharmacokinetic (pK)~     profiles.~      This study was designed to address the following hypotheses:~        -  Vaginally-formulated tenofovir 1% topical gel when applied rectally will be safe using a~          combination of clinical and laboratory markers including assays specifically designed to~          measure mucosal toxicity~        -  Tenofovir will be detectable at different concentrations in the various anatomic~          compartments sampled for pharmacokinetics following single and 7-day topical exposures~        -  Exposure to tenofovir 1% gel will demonstrate prevention of ex vivo HIV-1 challenge~          using in vivo drug-exposed tissue as compared to baseline tissue samples~        -  Orally delivered, single dose, 300 mg tenofovir disoproxil fumarate tablets will have~          similar safety profiles using routine blood safety indices as have been established in~          other trials and will show no mucosal safety concerns~        -  The oral dose will have different multi-compartment concentration kinetics than the~          topical tenofovir and will also demonstrate preliminary (ex vivo) prevention using the~          explant infectivity assay~        -  Vaginally formulated tenofovir 1% topical gel applied rectally will be acceptable to~          participants, as indicated by a score in the upper one third of the 10-point Likert~          scale on intentionality to use in the product in the future~   "
196982|NCT00984958|"~     The aim of this prospective, randomized study of Bulkamid treatment is to investigate the~     efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to~     TVT-procedure because of suspected ISD.~   "
197085|NCT00983619|"~     The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551)~     in subjects with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose~     (MTD), or if not reached, at optimal biologic dose (OBD).~   "
196985|NCT00984919|"~     RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory~     may help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at a biomarker, 11-dh-TXB2, in blood and urine~     samples from patients with prostate cancer and healthy volunteers.~   "
196986|NCT00984906|"~     The aim of the study is to measure the inspiratory flow that the different patient groups~     (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease~     (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In~     addition, the handling and acceptability of the inhalers will be compared in asthmatic~     children.~   "
196987|NCT00984893|"~     The study will assess the real life effectiveness of zoledronic acid in the management of~     patients with osteoporosis over 4 years of treatment. Zoledronic acid will be compared to~     oral bisphosphonates (OBP) with respect to the change in Bone Mineral Density (BMD) and~     incidence of fractures.~   "
196988|NCT00984880|"~     The primary purpose of this study is to assess the safety and tolerability of AZD3043~     following administration of single ascending bolus doses (Part A) and single ascending bolus~     doses followed by infusion (Part B).~   "
196989|NCT00984867|"~     This study aims to investigate how dapagliflozin can control blood sugar in patients with~     type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with~     metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.~   "
196990|NCT00984854|"~     The purpose of this study was to investigate the safety and toleration of various doses of~     intradermal Juvidex (mannose-6-phosphate) administered to punch biopsies of normal subjects.~   "
196991|NCT00984841|"~     The purpose of this study is to determine if tailored letters sent to diabetic patients will~     improve care of diabetes.~   "
196992|NCT00984828|"~     The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. All~     patients will receive 4 cycles of velcade and Dexamethasone as front-line therapy. Then~     patients will be randomized into standard group which will receive a single autologous~     hematopoietic stem cell transplantation with standard conditioning of melphalan 200mg/m2 and~     the study group which will receive single autologous hematopoietic stem cell transplantation~     with conditioning of melphalan 200mg/m2 + velcade followed by 3 more cycles of velcade alone~     as consolidation.~   "
196993|NCT00984815|"~     The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a~     fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients~     that require long-term NSAID treatment.~   "
196994|NCT00984802|"~     This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV)~     injection, and to evaluate efficacy on the basis of the changes seen in the cardiac~     biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of~     the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be~     explored.~   "
196995|NCT00984789|"~     400 healthy women needed contraception will be asked to participate in this study. Half will~     be given EVRA, half will be given FC Patch low. They will be expected to apply the patches~     for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of~     menstrual bleeding on these two treatments, plus how effective they are at preventing~     pregnancy, general safety, and their acceptability to the participants.~   "
196996|NCT00984776|"~     MRI has the ability to visualize the arterial vessel wall. Wall thickening and~     atherosclerotic plaque components can be visualized in the carotid arteries and the aorta.~     Previous studies also demonstrated the ability of MRI to visualize the coronary vessel wall.~     The ultimate goal of coronary vessel wall imaging is to detect vulnerable atherosclerotic~     plaque thereby. This might prevent complications, e.g., chest pain (angina) or myocardial~     infarction.~      The goal of this study was to validate MRI of the coronary vessel wall by comparing it to~     intravascular ultrasound (IVUS), to detect atherosclerotic plaque in the coronary vessel wall~     and to look at the uptake of the albumin-binding contrast agent gadofosveset in~     atherosclerotic plaques. The main hypothesis is that due to the albumin binding~     characteristics, uptake of the contrast agent will take place in the more vulnerable plaques~     compared to less vulnerable plaques. MRI will be compared to X-ray coronary angiography and~     intravascular ultrasound, two techniques currently considered as the standard of reference~     for imaging of the coronary arteries and vessel wall.~   "
196997|NCT00984763|"~     Malaria is a parasite, infection with which kills over 2 million people each year. It is a~     major problem for those who live in endemic areas and for travellers. There is a great need~     for a safe effective malaria vaccine. The purpose of this study is to examine a new vaccine~     designed to provide immunity during the blood stage of the malaria parasite's lifecycle.~      The vaccine consists of AMA1-C1 which is a mixture of two recombinant synthetic AMA1 proteins~     from two Plasmodium falciparum strains, Alhydrogel® which is an aluminium-based adjuvant and~     CPG 7909 - an oligodeoxynucleotide, which enhances immune response.~      This study will enable the investigators to assess:~        1. The ability of of a growth inhibition assay to predict the effectiveness of a malaria~          vaccine.~        2. The safety of the vaccine in healthy volunteers~        3. The response of the human immune system to the vaccine~   "
197014|NCT00984542|"~     RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line~     therapy in treating patients with relapsed or refractory small cell lung cancer.~   "
197015|NCT00984529|"~     The purpose of this study is to determine whether treatment with candesartan cilexetil for at~     least 6 months in patients with chronic heart failure improves clinical signs and symptoms of~     chronic heart failure.~   "
197016|NCT00984516|"~     The purpose of this study was to investigate the scar-improvement efficacy of three doses of~     intradermal Juvidex given once only or three times in male and female subjects and to collect~     further safety and tolerability data for intradermal Juvidex in male and female subjects.~   "
197017|NCT00984503|"~     The purpose of this study is to investigate the accelerated-healing potential of injection or~     injection plus topical application of Juvista to minor split skin grafts (SSG).~   "
197086|NCT00983606|"~     The primary objective is to assess the burden of respiratory disease in outpatient settings~     among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV~     prophylaxis during the infants' first RSV season.~   "
196998|NCT00984750|"~     Decreased insulin sensitivity (or insulin resistance) is a major risk factor for type 2~     diabetes mellitus and renal and cardiovascular disease. It is the key component and,~     possibly, a pathogenetic factor of the metabolic syndrome - a clustering of arterial~     hypertension, obesity, impaired glucose tolerance, dyslipidemia, coagulation abnormalities,~     albuminuria and increased cardiovascular risk - that may precede or accompany type 2~     diabetes.~      Insulin function and the abnormalities associated with insulin resistance, may have a major~     role in preventing type 2 diabetes and, in the long-term, diabetes micro- and macrovascular~     complications. Carnitine is involved in lipids and carbohydrates metabolism and~     acetyl-L-carnitine (ALC), an intramitochondrial carrier of acylic group, may modulate cell~     fuel substrate utilization. Studies found that carnitine may improve insulin sensitivity and~     glucose disposal in healthy subjects and in patients with type 2 diabetes. A recent study~     found that a primed constant infusion of acetyl-L-carnitine (ALC) may increase glucose~     utilization in type 2 diabetic patients, possibly restoring the glycogen synthase activity.~      In a previous pilot study in healthy subjects with decreased insulin sensitivity, the~     investigators found that 6-month treatment with Acetyl-L-Carnitine - an ester of l-carnitine~     - improved the glucose disposal rate, taken as a marker of insulin sensitivity. Amelioration~     of insulin sensitivity was associated with a significant and clinically relevant reduction in~     systolic blood pressure without appreciable changes in diastolic blood pressure. Whether~     blood pressure reduction reflected the amelioration of insulin sensitivity or, rather, a~     direct, specific effect of Acetyl-L-Carnitine is still unknown.The antihypertensive effect~     ensued progressively and slowly waned after treatment withdrawal as documented by a slow and~     progressive increase in blood pressure levels toward baseline levels over the recovery~     period. This finding provided convincing evidence that blood pressure reduction throughout~     the observation period was not explained by a trial effect, but reflected a true treatment~     effect. Blood pressure was a secondary efficacy variable of the study and mechanisms~     underlying the antihypertensive effect of Acetyl-L-Carnitine (such as reduced peripheral~     resistances, decreased cardiac output, increased artery compliance and/or enhanced sodium~     excretion), in this population were not assessed.~      Acetyl-L-Carnitine was well tolerated in all of the patients and may provide a novel~     therapeutic tool for the treatment of arterial hypertension, and of dyslipidemia and could be~     safely used in people with type 2 diabetes.~      Thus, the investigators designed a prospective, randomized, double-blind, placebo-controlled~     trial to investigate whether Acetyl-L-Carnitine added-on stable and standardized blood~     pressure and lipid lowering therapy may help further improving control of hypertension and~     dyslipidemia and, therefore, decreasing the overall cardiovascular risk in hypertensive~     patients with type 2 diabetes.~   "
196999|NCT00984737|"~     Newly diagnosed hyperglycemia (NDH) and stress hyperglycemia (SH) during acute illness is~     reported as a non-physiological condition in hospitals. The investigators aim is to determine~     the rate of NDH and SH among cases admitted to coronary ICU with acute coronary disease and~     to inquire the relationship of SH with disease severity and functional outcomes such as~     longevity of ICU stay.~   "
197000|NCT00984724|"~     The goal of this research study is to learn the effectiveness of telephone-based counseling~     on helping smokers change their smoking patterns.~   "
197001|NCT00984711|"~     This study was designed to gather data regarding the efficacy and safety of Rituxan in~     clinical practice whereby patients may present with concomitant medical conditions,~     medications as well as varying presentations of rheumatoid arthritis not always captured~     within the purer population seen in an industry sponsored clinical trial.~   "
197002|NCT00984698|"~     The purpose of this study is to test the effectiveness of group psychotherapy designed~     specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder~     (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily~     routine.~   "
197003|NCT00984685|"~     The purpose of the study is to identify the barriers for effective treatment of depression,~     specifically whether modified CHIS Scale is a valid tool for identifying the high risk~     patients for depression.~   "
197004|NCT00984672|"~     Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved,~     has increased recently due to the morbidity associated with harvest of iliac crest bone graft~     in spinal arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT~     Cage, other clinical applications of these proteins is becoming widely adopted due to their~     effectiveness in forming bone and facilitating fusion. Clinicians have realized while these~     proteins are potent stimulators of bone formation there have been anecdotal reports of~     increased rates of radicular pain in the postoperative period when used in interbody~     arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to~     be due to the inflammatory effects of these proteins. Excess bone overgrowth around the~     spinal nerves in proximity to the fusion cage has been reported. No prospective studies have~     been performed assessing the incidence and etiology of this complication. The investigators~     propose a prospective study evaluating the incidence of this complication as well as~     postoperative imaging studies to help determine whether bony overgrowth is indeed occurring~     adjacent to the effected spinal nerves.~   "
197005|NCT00984659|"~     The purpose of this study is to evaluate a new questionnaire to capture the patient~     experience of COPD. The information collected will be used to validate the Shortness of~     Breath with Daily Activities Questionnaire.~   "
197006|NCT00984646|"~     The purpose of this study was to investigate the scar-reducing properties of eight doses of~     intradermal Prevascar (IL-10).~   "
197007|NCT00984633|"~     The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org~     9426 in maintenance of muscle relaxation in adult subjects undergoing general elective~     surgery.~   "
197008|NCT00984620|"~     To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI~     201335 at a dose of 120 mg once daily, with a 24-week background of pegylated~     interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with~     hepatitis C virus (HCV) genotype 1~   "
197009|NCT00984607|"~     The purpose of this study is to correlate accurate fluoroscopic measurement of gastric band~     stoma diameter with patient symptoms for optimal band stoma adjustment. Administration of a~     barium tablet to gastric band patients with dilute liquid barium allows the accurate~     measurement of the band stoma diameter. The technique is quick, easy to perform, and~     eliminates magnification error intrinsic to fluoroscopy. The study data suggests the optimal~     calibrated gastric band stoma diameter is 3.0 mm. The accurate fluoroscopic measurement of~     gastric band stoma diameter can optimize band stoma adjustment and improve patient outcomes.~   "
197010|NCT00984594|"~     The objective of this study is to determine how effective a plug made out of human bone~     (called CR-Plug) will be in the treatment of smaller, focal defects (like the injury the~     patient has to their knee).~   "
197011|NCT00984581|"~     To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal~     avotermin (Juvista) in young females.~   "
197012|NCT00984568|"~     This study will be performed to compare the efficacy and safety of the classical Step-Up~     approach for treatment of moderate-to-severe active ulcerative colitis using oral~     prednisolone + oral 5-aminosalicylic acid (5-ASA) or oral prednisolone + oral azathioprine~     (AZA) with a more intensive and early Top-Hold approach with intravenous infliximab (5~     mg/kg) administered at Weeks 0, 2, and 6 and 8 weeks thereafter.~   "
197013|NCT00984555|"~     The purpose of this study is to examine the vaginal residence time of certain semen~     biomarkers.~   "
197018|NCT00984490|"~     RATIONALE: Metformin hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying how well metformin hydrochloride works in treating~     women with stage I or stage II breast cancer that can be removed by surgery.~   "
197019|NCT00984477|"~     The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by~     the body when given to healthy, non smoking males at different dose levels. This is a 2 part~     study, in Part B a single group of subjects will be given both an oral dose and intravenous~     microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.~   "
197020|NCT00984464|"~     The purpose of this Phase 2 study is to investigate whether intravenous administration of~     REOLYSIN therapeutic virus in combination with paclitaxel and carboplatin is effective and~     safe in the treatment of metastatic melanoma.~   "
197021|NCT00984451|"~     Background:~        -  The influenza A virus can cause infections that lead to fever, cough, muscle aches,~          diarrhea, and headaches, and can even be fatal in some people. Seasonal influenza kills~          an estimated 36,000 people in the United States each year. In addition, more than~          200,000 people are hospitalized for flu-related complications. Influenza A has a~          substantial health effect on every age group.~        -  Currently, treatments are available for influenza A, but there is concern that the rate~          of complications or even death from this infection is still high despite treatment, and~          that over time this virus may become resistant to these treatments. Researchers are~          interested in developing a possible new treatment that uses antibodies against influenza~          A virus.~      Objectives:~      - To collect plasma (the liquid component of blood containing antibodies) from people who~     have high levels of antibodies against the influenza A virus because they either have been~     previously infected with the virus or have been vaccinated against the infection.~      Eligibility:~        -  Healthy male volunteers between 18 and 60 years of age who are eligible to donate blood.~        -  Individuals must have previously either recovered from influenza infection or have been~          vaccinated against the infection, and may be subject to other restrictions on~          participating in National Institutes of Health research studies.~      Design:~        -  Volunteers will undergo apheresis, an outpatient procedure in which researchers will~          collect plasma containing antibodies against the influenza virus by drawing blood into a~          special machine that separates blood cells from the liquid portion under sterile~          conditions and then returns the blood cells to the donor.~        -  Volunteers will be screened with blood tests to ensure that they are eligible to~          participate and donate blood.~        -  Volunteers are asked to undergo at least 3 sessions of apheresis; if willing, they can~          volunteer to participate in up to 20 sessions.~        -  After plasma is collected, it will be tested to ensure that it can be used to safely~          develop treatments for patients who have influenza A infection.~   "
197022|NCT00984438|"~     The purpose of this research study is to try and identify a more effective treatment plan to~     improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain~     tumor that can be removed by brain surgery.~      The study will record what effects (good and bad) the combination of surgery with~     chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery~     and post-operative chemotherapy has on the patient and their survival rate over the next 12~     months.~   "
197023|NCT00984425|"~     Over the last decade, improvements in the investigators' understanding of the molecular basis~     of cancer have led to the clinical development of protein kinase inhibitors, which target~     pivotal molecules involved in intracellular signaling pathways implicated in tumorigenesis~     and tumor progression. Lapatinib is an oral selective and reversible inhibitor of the~     tyrosine kinase domain of epidermal growth factor receptor (EGFR) and human epidermal growth~     factor receptor type 2 (HER-2), which are both frequently altered in human malignant tumors.~     Sorafenib is an oral multi-kinase inhibitor with a dual-action that prevents tumor cell~     proliferation and angiogenesis. The investigators suggest that through a complete blockade of~     ErbB signaling network it may be possible to ''sensitize'' tumor cells to antiangiogenic~     therapy, by lowering the tumor cell survival threshold, while through inhibition of vascular~     endothelial growth factor (VEGF) pathway to circumvent the problem of acquired resistance to~     EGFR inhibitors. Based on this theoretical rationale we decide to test the combination of~     Lapatinib and Sorafenib. This phase I trial will be undertaken to assess the maximum dose~     tolerated (MTD), safety/tolerability, pharmacokinetics and antitumor efficacy of this~     combination in patients with advanced, recurrent or metastatic solid cancers refractory to~     available standard treatment.~   "
197024|NCT00984412|"~     Refractory acute leukemia (AL) occurs in a significant percentage of the AL patients and~     presents a therapeutic challenge. Allogeneic stem cell transplantation (allo-SCT) is the only~     curative option for these patients. Although many of the patients with refractory AL that~     undergo myeloablative SCT initially achieve complete remission, most relapse later on, and~     the long-term disease free survival is poor. In order to achieve better leukemic control,~     most transplant centers employ post transplant early withdrawal of the anti-GVHD~     immunosuppression; hence exposing the patients to high risk of GVHD associated morbidity and~     mortality. This study will try to address this common scenario, namely early and late~     relapse. The investigators will try to attain better leukemic control by re-inducing the~     patients, 6 weeks after the 1st transplant with further myeloablative treatment (busulfex and~     thiotepa) followed by allogeneic stem cell support (transplant II).~   "
197025|NCT00984399|"~     The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast~     cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina.~     It relieves vaginal dryness. Women who have had breast cancer are usually told not to take~     estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new~     primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the~     vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise~     in your estrogen level. However, there is no clear evidence that this would cause any bad~     effects in patients with breast cancer. How much, if any, of these topical estrogens are~     absorbed through the vagina is not known. We also do not know what the impact is of low dose~     estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the~     mucus membranes are restored after estrogen exposure.~   "
197026|NCT00984386|"~     The purpose of this study is to investigate early wound healing of one application of four~     different doses of intradermal Zesteem (17β-Estradiol) in male subjects and female subjects~     two years post-menopausal.~   "
197027|NCT00984373|"~     The purpose of this study is to provide accurate, reliable information on schizophrenia~     clinical management in order to detect unmet medical needs of this disease in terms of:~        -  Patient characteristics.~        -  Diagnostic and treatment approaches: initial and subsequent.~   "
197028|NCT00984360|"~     The purpose of this study is to determine whether methamphetamine-dependent individuals will~     use less methamphetamine when treated with naltrexone. The study will also investigate~     whether individuals with the mu opioid receptor gene variant A118G will use less~     methamphetamine than individuals without A118G.~   "
197029|NCT00984347|"~     The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for~     induction of labor in term pregnancies.~   "
197030|NCT00984334|"~     For many patients taking opioids for pain relief one of the most distressing side effects is~     constipation. Naloxone is effective in the reversal of the effects of opioids and is used~     following opioid overdose. If naloxone is given by mouth it would relieve the effects of~     constipation but as it goes into the blood stream very quickly, it would also reverse the~     effects of the opioid and therefore stop the pain relief. The aim of this study is to examine~     a slow release formulation of naloxone to see if is can reduce constipation without reducing~     the pain relieving effects of the opioid.~   "
197031|NCT00984321|"~     The purpose of this study is to examine whether psychoeducation counseling for older cancer~     patients undergoing treatment is feasible and worthwhile. The investigators will test this in~     a group or individual phone counseling format. Many cancer patients seek counseling to help~     with the emotional burden of their illnesses. Counseling often helps them cope with cancer by~     giving them a place to express their feelings. This geriatric-specific psychoeducation is~     intended to help older cancer patients cope with the burden of cancer and aging. The purpose~     of this study is to see if this type of counseling helps reduce depressive symptoms, anxiety,~     perception of loneliness and isolation. In addition this counseling aims to improve coping~     and quality of life (QOL).~      Individuals who choose not to take part in the intervention study will be asked if they are~     willing to participate in a brief refusal sub study. The purpose of the refusal substudy is~     to compare levels of distress in patients that choose to participate and those that decline.~     This will yield valuable data that will help us distinguish between patients that decline due~     to lack of interest in research and those that decline due to high levels of distress.~     Participation in the refusal sub study consists of completion of 2 brief questionnaires.~   "
197032|NCT00984308|"~     Sleep apnea is common among Veterans with cerebrovascular disease (stroke or transient~     ischemic attack [TIA]), leads to hypertension, and is associated with recurrent stroke and~     death. Although continuous positive airway pressure (CPAP) safely treats sleep apnea, few~     Veterans with cerebrovascular disease are diagnosed with sleep apnea or offered treatment.~   "
197033|NCT00984295|"~     This study will assess the safety and immunogenicity of ProQuad when administered~     concomitantly and nonconcomitantly with Tripedia and Comvax.~   "
197034|NCT00984282|"~     Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic~     differentiated thyroid cancer refractory to radioiodine~   "
197035|NCT00984269|"~     This is a prospective, randomized, equivalence trial designed to evaluate postoperative~     complications following hand surgery with a brachial tourniquet and without a tourniquet in~     patients that have previously had a mastectomy with axillary node dissection with or without~     radiation treatment or history of lymphedema.~   "
197036|NCT00984256|"~     The purpose of this study is to determine whether Malarone ®, which is a drug approved to~     prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.~   "
197037|NCT00984243|"~     This study is being done to determine whether a substance called hematoporphyrin can be used~     to treat tumors in various locations in the body when used in association with a laser.~     Hematoporphyrin is a substance that is taken up by cancerous cells. When these cells are~     exposed to the energy emitted by a laser source, chemical reactions occur in the cell and~     cause the cells to die. It is hoped that this treatment method may be able to selectively~     destroy malignant cells without damaging surrounding healthy tissue.~   "
197038|NCT00984230|"~     The purpose of this clinical trial is to identify the infant formula(s) for which the~     investigators get the closest gut maturation index compared to the one they get with~     breastfed babies.~   "
197039|NCT00984217|"~     Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery~     followed by postoperative radiation therapy. Retrospective studies have shown the superiority~     of combined modality therapy compared to surgery alone for patients with advanced T or N~     stage. Despite the addition of postoperative radiation therapy, the five-year survival for~     locally advanced salivary gland malignancies is poor (less than 60%). In salivary gland~     malignancies, the epidermal growth factor receptor (EGFR) is expressed in 25-85%; in certain~     histological types, like salivary duct carcinomas, the expression is higher. EGFR is a~     promising target of anticancer therapy. In squamous cell carcinoma of the head and neck, a~     phase III trial utilizing cetuximab added to radiation therapy improved both locoregional~     control and overall survival compared to radiation alone. Panitumumab is a novel, human, IgG2~     EGFR monoclonal antibody that may be better tolerated and more efficacious than cetuximab.~     Here, the investigators suggest that the addition of panitumumab to standard radiotherapy in~     locally-advanced salivary gland malignancies will improve recurrence-free survival (RFS).~   "
197040|NCT00984204|"~     The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo~     cardiac ablation system can eliminate typical atrial flutter and that its use does not result~     in an unacceptable risk of serious adverse events (SAE's).~   "
197041|NCT00984191|"~     The purpose of this trial is to see if the 99mTechnetium-MIBI SPECT-CT can be a tool for~     preoperative evaluation of cervical node metastasis in papillary thyroid cancer.~   "
197042|NCT00984178|"~     The aim of this study is to compare the effectiveness of four different strategies for~     preventing the ventricular postinfarction remodelling: 1) Conventional treatment for~     reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells~     intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by~     granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells~     transplantation plus mobilization with G-CSF).~   "
197055|NCT00984009|"~     Grapefruit juice is an inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the~     enzyme systems responsible for the metabolism of colchicine. This study will evaluate the~     effect of multiple daily consumptions of grapefruit juice on the pharmacokinetic profile of a~     single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and~     tolerability of this regimen in healthy volunteers. All study subjects will be monitored for~     adverse events throughout the study period.~   "
197056|NCT00983996|"~     The objective of this study is to investigate the bioequivalence of Mylan's alendronate~     sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10~     mg) dose administration under fasting conditions.~   "
197043|NCT00984165|"~     Background:~        -  Allogeneic hematopoietic stem cell transplantation (allotransplant) has been used to~          treat many kinds of cancer that develop in cells from the blood or immune system. After~          allotransplant, donor cells take over production of the recipient s blood and immune~          cells, and donor immune cells can directly attack and control tumor. However, for~          cancers that do not respond to allotransplant, there are no proven cures.~        -  A single treatment with radiation can improve the potency of immune-cell therapies. This~          is probably because the tumor tissue is damaged in a way that new tumor proteins are~          exposed, attracting immune cells to the tumor. By giving only a single dose of~          radiation, the immune cells that are attracted to the tumor are allowed to survive and~          function in their usual way, traveling throughout the body and educating other immune~          cells to recognize tumor, and to activate and expand in order to kill the tumor cells.~          Some research has shown that radiation may have a widespread effect on stimulating the~          immune system, educating immune cells to recognize and control tumors that have not been~          radiated.~      Objectives:~      - To determine whether a single treatment of radiation will help donor immune cells control~     cancer after allotransplant without causing excessive side effects.~      Eligibility:~        -  Recipients: Individuals 18 years of age and older who have blood cancers that have not~          responded to allotransplant.~        -  Donors: Healthy individuals 18 years of age and older who were previous allotransplant~          donors for one of the study recipients.~      Design:~        -  Donors will provide additional blood immune cells, called lymphocytes, through~          apheresis. Apheresis involves drawing blood, separating out the lymphocytes, and~          returning the rest of the blood to the donor.~        -  Recipients will receive a single dose of radiation to the greatest amount of tumor that~          can be irradiated safely. Researchers will intentionally leave some tumor that will not~          be radiated in order to evaluate whether there is a widespread response to the~          treatment.~        -  There are two treatment arms on the study.~        -  Arm 1: Study participants who have donor lymphocytes available and who have not had~          major complications from the allotransplant will be given a dose of donor cells after~          they receive radiation, to provide an additional boost to the donor immune response.~        -  Arm 2: Study participants who cannot receive donor lymphocytes because their donor is~          not available, they received an allotransplant from a partially matched relative, or~          they have had significant complications from the allotransplant - will receive radiation~          without additional donor lymphocytes.~        -  All recipients will be followed closely for side effects and for tumor response to~          radiation with or without donor lymphocytes. Additional tests will be performed,~          including tumor biopsies, bone marrow samples, and blood draws, in order to study the~          immune effects of radiation and donor lymphocytes.~        -  A separate, control group of allotransplant recipients will not receive radiation. This~          group will include participants whose transplant doctors plan to use donor lymphocyte~          therapy alone to control cancer progression. This group will donate blood immune cells~          through blood draws and apheresis. These cells will be examined to study the immune~          effects of receiving donor lymphocytes without radiation.~   "
197044|NCT00984152|"~     Raltegravir not only has a unique mechanism of action, but may also have other unique effects~     on suppression of viral replication, viral reservoir, and immune reconstitution in blood and~     other important compartments. This may in part be due to the pharmacokinetics of Raltegravir~     in blood and gut tissue. Efavirenz will be the comparator antiretroviral drug in this study,~     with both drugs being used as part of a three-drug regimen with tenofovir and emtricitabine.~      The primary objectives are to determine differences in the effects of 2 anti-retroviral~     regimens, Raltegravir + Truvada versus Atripla, with respect to:~        1. Viral load in plasma, genital tract (vaginal secretions), and gut (by in situ~          hybridization).~        2. Latent viral reservoir (pro-viral DNA) in the peripheral blood and genital tract.~        3. Immune effects (CD4/CD8 immunophenotypes) in gut and PBMCs and plasma cytokine profiles.~      The secondary objective is to determine the pharmacokinetics of Raltegravir in blood and gut~     tissue; relative tissue/compartment penetration compared to Efavirenz.~   "
197045|NCT00984139|"~     This phase IV open study will evaluate the persistence of humoral antibodies against~     hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in~     adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals'~     recombinant hepatitis B vaccine (Engerix™-B) in infancy.~   "
197046|NCT00984126|"~     This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.~      The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in~     Haemophilia A patients.~      The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and~     NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600~     (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September~     2011) and NN7008-4015 (start: August 2012, stop: March 2013).~   "
197047|NCT00984113|"~     The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its~     metabolite in patients with mild, moderate, and severe renal impairment compared to healthy~     volunteers.~   "
197048|NCT00984100|"~     Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of~     investigational surgery which uses the endoscope as the primary operative tool. The insertion~     sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra.~     Multidisciplinary teams of surgeons and gastroenterologists collaborate to develop safe and~     effective surgical techniques via the natural orifice route in order to avoid surgical~     incisions. Early studies have focused on transvaginal surgery as the access route to the~     abdomen as it sidesteps troubling questions about infection and closure of the organ. This~     study is a pilot study to test the feasibility to NOTES transvaginal cholecystectomy using~     conventional surgical and endoscopic tools.~   "
197049|NCT00984087|"~     rTMS is a promising, though largely untested, option for treating adolescent and young adult~     depression. This study hypothesizes that rTMS will safely and significantly alleviate~     depression and decrease suicidal ideation in adolescents and young adults based on previous~     studies.~   "
197050|NCT00984074|"~     RATIONALE: Diagnostic procedures, such as specialized types of magnetic resonance imaging~     (MRI), may help in planning radiation therapy that does less damage to normal tissues.~      PURPOSE: This phase I trial is studying using functional MRI to see how well it works in~     planning radiation therapy in patients undergoing radiation therapy to the base of the skull~     and/or brain for nonmetastatic head and neck cancer.~   "
197051|NCT00984061|"~     Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and~     P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is~     responsible for the efflux of colchicine across membranes. This study will evaluate the~     effect of clarithromycin-related inhibition of CYP 3A4 and P-gp on the pharmacokinetics of~     colchicine. It will also evaluate the safety and tolerability of concurrent administration of~     clarithromycin and a single dose of colchicine.~   "
197052|NCT00984048|"~     This is a multicenter translational study to understand therapeutic resistance in patients~     undergoing first-line chemotherapy (FOLFOX/Avastin, or FOLFIRI/Avastin) for metastatic~     colorectal cancer. Tissue samples from liver metastasis will be collected and banked before~     the start of chemotherapy and at the time of progression. Additionally, blood samples will be~     drawn monthly and stored in the tissue biobank.~   "
197053|NCT00984035|"~     The purpose of this study is to identify novel biomarkers of kidney injury in patients~     receiving cisplatin.~      This study will also collect DNA for future analysis.~   "
197054|NCT00984022|"~     This study compares Aquacel against routine Iodoform packing for packing abscess cavities~     after incision and drainage. It is hypothesized that Aquacel will produce speedier healing of~     the abscess.~   "
197057|NCT00983983|"~     The purpose of this study is to determine the safety, tolerability, and preliminary efficacy~     of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic~     lateral sclerosis (ALS) (Lou Gehrig's disease).~   "
197058|NCT00983970|"~     Exercise is an important component in the treatment of of child obesity and associated~     medical conditions. However, one of the strongest predictors of non-compliance from exercise~     programs in obese youth is lack of enjoyment, thus creating a more pleasurable environment,~     by using TV or video games as incentives, may be an effective way of increasing exercise in~     obese youth. The purpose of this study was to compare interactive video game stationary~     cycling (GameBike ®) with cycling to music on aerobic fitness, body composition,~     cardiovascular disease risk markers, and exercise behaviour as measured by attendance, energy~     expenditure, duration, intensity and distance pedaled in obese adolescents. Twenty six obese~     adolescents had an equal chance of being assigned to either interactive video game cycling~     (n=13) or cycling to music serving as controls (n=13). The 10-week program consisted of twice~     weekly sessions lasting a maximum of 60 minutes per session.~   "
197059|NCT00983957|"~     The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of~     Ortho Tri-Cyclen® in healthy female subjects.~   "
197060|NCT00983944|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving rituximab together with combination chemotherapy may kill more~     cancer cells. It is not yet known which combination chemotherapy regimen is more effective~     when given with rituximab in treating large B-cell lymphoma.~      PURPOSE: This randomized phase II trial is studying how well rituximab and combination~     chemotherapy work when given with or without bleomycin sulfate in treating patients with~     primary mediastinal large B-cell lymphoma.~   "
197061|NCT00983931|"~     Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).~     Cyclosporine is a potent inhibitor of both CYP3A4 and P-gp. This study will evaluate the~     effect of single-dose cyclosporine on the pharmacokinetic profile of a single 0.6 mg dose of~     colchicine. A secondary objective is to evaluate the safety and tolerability of this regimen~     in healthy volunteers. All study subjects will be monitored for adverse events throughout the~     study period~   "
197062|NCT00983918|"~     To the investigators' knowledge, no study has looked at differences in postoperative pain~     when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and~     propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total~     intravenous anesthesia with propofol will lead to less postoperative pain in the first 24~     hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with~     isoflurane, desflurane or sevoflurane.~      PURPOSE~      To find out if maintenance of anesthesia with propofol leads to less postoperative pain after~     laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane,~     desflurane, or sevoflurane.~   "
197063|NCT00983905|"~     Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe~     substrate. When the two are co-administered the potential exists for a clinically significant~     drug interaction. This study aims to determine the effect of steady-state colchicine on the~     pharmacokinetics of theophylline administered as a single dose. A secondary goal is to~     evaluate the safety and tolerability of this regimen in healthy volunteers. All study~     subjects will be monitored for adverse events throughout the entire study period.~   "
197064|NCT00983892|"~     Given the growing strain on the Veterans Administration resulting from increasing caseloads~     of cancer patients, interventions are badly needed that assist patients in managing their~     illness, improve quality of life and avoid acute episodes that result in urgent care use and~     increased mortality. Previous studies have found that cancer patients undergoing chemotherapy~     can effectively manage their own symptoms when monitored using automated telephone calls.~     Such technology, however, may challenge the number of Veterans who lack social support and/or~     independence. The goal was to develop and test a technology that not only monitors patients~     automatically by telephone, but also gives them self management advice and engages a friend~     or family member to serve as a CarePartner willing to play a limited role in identifying~     patient symptoms and psychosocial needs to reinforce self management and provide social~     support. The investigators found that this technology indeed helped patients better control~     their symptoms, especially when a caregiver participated in the program along with them.~   "
197065|NCT00983879|"~     The purpose of this natural history study is to understand more about the progression of~     infantile Krabbe disease, a very rare genetic disease. There is very little published~     longitudinal data with only anecdotal cases. This natural history study will be important in~     understanding the effect of future therapies that are presently in the preclinical phase.~   "
197066|NCT00983866|"~     The goal of this study is to determine whether having a telephone discussion with a nurse~     educator about making treatment decisions and participating in a clinical trial increases~     trial participation.~      The investigators hypothesize that the participants in the intervention group will be more~     likely to take part in a clinical trial than those in the usual care group.~   "
197067|NCT00983853|"~     The purpose of this study is to determine whether the combination of telaprevir,~     peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus~     (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus~     (HIV).~   "
197068|NCT00983840|"~     Poor diets lead to weight problems, and may increase cancer risk. Cancers may develop over a~     long period of time, with some possibly initiating in childhood. Therefore, promoting healthy~     diets and preventing excess weight gain during childhood could be cancer protective. Families~     influence children's dietary behaviors by their actions and controlling the home food~     environment. The internet provides family access to interventions with the convenience of the~     home. An eight-session interactive web-based program promoting a healthy home food~     environment for African-American families with 9-12 year old daughters (Family Eats) was~     previously developed and tested. This study tests whether the Family Eats web program~     improves diet and weight outcomes among 320 African-American families with 8-12 year old~     children. This important study will pioneer a new channel for behavior change intervention~     with African-American families and holds the promise of reaching large numbers of children~     and their families, enabling all to adopt healthy eating behaviors and achieve energy balance~     and reduce cancer risks.~   "
197070|NCT00983814|"~     Attention Deficit Hyperactivity Disorder (ADHD) is a neurobiological disorder characterized~     by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness,~     restlessness, talking out of turn, difficulty waiting and interrupting others. ADHD is the~     second most common neuropsychiatric disorder affecting 4.4% of the US adult population, or~     between 8-9 million individuals (Kessler et al., 2006).~      Droxidopa (L-dihydroxyphenylserine (L-DOPS)) is a synthetic catecholamine which is converted~     to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE centrally in~     the CNS and peripherally. Co-treatment with carboxylase inhibitors, such as carbidopa, given~     with droxidopa, can increase the CNS levels of NE with greater crossing of the blood-brain~     barrier. Droxidopa has received orphan drug approval by the FDA for the treatment of~     symptomatic neurogenic orthostatic hypotension in individuals with primary autonomic failure.~     The half-life of droxidopa is approximately 2-3 hours, resulting in administration thee times~     daily.~      As adult ADHD is characterized as a disorder of decreased NE activity in the pre-frontal~     cortex, it is hypothesized that treating patients with droxidopa (in co-administration of~     carbidopa) will have a positive effect on adult ADHD.~   "
197071|NCT00983801|"~     The purpose of this study was to determine whether ixabepilone is effective in the treatment~     of unresectable or metastatic gastric cancer in Asian participants.~   "
197072|NCT00983788|"~     The investigators propose to evaluate the effect of bezafibrate on metabolism during exercise~     in 22 adult patients affected with carnitine palmitoyltransferase II (CPTII) or very-long~     chain acyl-CoA-dehydrogenase (VLCAD) deficiencies. This study will be an 9-month, randomized,~     double-blind, placebo-controlled crossover trial. The trial will be conducted in two centers:~     Institut de Myologie, Pitié-Salpêtrière Hospital in France, and Rigshospitalet, University of~     Copenhagen, in Denmark. The main criteria for assessing the potential effect of this drug~     will be the fat oxidation rate studied during a moderate workload on cycle ergometer, after~     infusion of stable isotopes (palmitate and glucose tracers).~   "
197073|NCT00983775|"~     The purpose of this study is to compare the pharmacological profile of insulin administered~     with jet-injection with that of insulin injected with a conventional insulin pen.~   "
197074|NCT00983762|"~     A functional outcomes comparison study of three surgical techniques using minimally invasive~     surgery mini-incision (MIS) for total knee arthroplasty (TKA), standard para-patellar TKA and~     the unicompartmental knee arthroplasty performed over a 2+ year post-op period.~   "
197075|NCT00983749|"~     The purpose of this study is to determine if external counterpulsation (ECP) is feasible to~     perform, tolerable, and safe as a treatment for patients with acute ischemic stroke (i.e., a~     blockage of one of the arteries supplying a part of the brain), and to assess what type of~     effect it might have on 1) the velocity of blood flow in the arteries supplying the brain and~     2) stroke symptoms. The hypothesis of the study is that ECP will be feasible and safe to~     perform, and will be tolerable for patients with acute ischemic stroke at pressures that~     increase the velocity of arterial blood flow to the brain.~   "
197076|NCT00983736|"~     The purpose of this clinical trial is to test an experimental drug therapy called Tramadol~     Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) (Tramadol HCl ODT or the study~     drug). The patient and the patient's partner are being asked to be in this clinical trial~     because they have a condition called Premature Ejaculation.~   "
197077|NCT00983723|"~     The study of plasma and urine proteomic profiles in patients with ischemic brain injury is~     important to better understanding of the mechanisms by which thrombolytic agents or other~     therapy affects clinical outcomes. The purpose of this study is to study the proteomic~     profile of patients with ischemic brain injury and compare it to control subjects without~     ischemic brain injury, subjects with other chronic neurologic diseases or systemic vascular~     diseases, and pre- and post- therapy which may be associated with, or predictive of,~     therapeutic outcome.~      The investigators hypothesize that there is a unique set of proteins expressed in serum and~     urine in patients with ischemic brain injury that may provide a more complete understanding~     of ischemic brain injury pathophysiology.~      Ultimately, this study may provide information of direct relevance to the medical care of a~     large proportion of patients with ischemic brain injury and other neurologic diseases in the~     future. And proteomic proteomic profile may provide important information about the roles of~     specific biomarkers. Perhaps the prevention of ischemic injury related complications.~   "
197078|NCT00983710|"~     This study will compare a newly-developed patient education program to help men with~     localized prostate cancer manage treatment-related side-effects versus usual care. The new~     intervention will be developed for men with lower health literacy. That means that the~     education materials will be developed for sixth grade reading level or lower. The materials~     will include lots of examples and illustrations to make it easier for people understand the~     information.~   "
197079|NCT00983697|"~     RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors~     find head and neck cancer and find out how far the disease has spread. It may also help~     doctors plan the best treatment.~      PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well~     it works in assessing the tumor and planning neck surgery in patients with newly diagnosed~     head and neck cancer.~   "
197080|NCT00983684|"~     The purpose of this study is to evaluate whether a single fraction of radiotherapy given~     intra-operatively and targeted to the tissues at the highest risk of local recurrence is~     equivalent to standard post-operative external beam radiotherapy after breast conserving~     surgery in women with early stage breast cancer in terms of local relapse within the treated~     breast.~   "
197081|NCT00983671|"~     Background: in various pediatric pulmonary diseases such as asthma, cystic fibrosis or~     bronchopulmonary dysplasia an increased inflammation is present. Measuring this inflammation~     is often hardly possible and requires invasive techniques such as bronchoscopy.~      With the use of exhaled breath condensate (EBC) or exhaled breath (EB) analysis it is~     possible to measure the inflammation in an non-invasive way. However, there is a great need~     to further standardise these measurements and to identify possible confounding factors.~   "
197082|NCT00983658|"~     This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed~     to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by~     IV infusion for the treatment of allergen-induced asthma.~   "
197087|NCT00983593|"~     The focus of the present study is to examine the relative efficacy of a mind-body method,~     know as Mind-Body Bridging, of treating DV offenders as compared to a treatment as usual~     (TAU) approach. The study will be conducted on-site at ACES, a non-profit agency that~     provides licensed domestic violence offender and substance abuse treatment services in the~     Salt Lake City area.~   "
197088|NCT00983580|"~     This phase II trial is studying how well giving acetylsalicylic acid together with~     eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention~     is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and~     eflornithine may prevent colorectal cancer.~   "
197089|NCT00983567|"~     This study will test a website for teens designed to help them improve both diet and physical~     activity. The website will have several components: educational messages, role model stories,~     goal setting, self-monitoring forms, problem solving, a monitored discussion forum, and diet~     and physical activity (PA) assessment questionnaires.~   "
197090|NCT00983554|"~     Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone;~     3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body~     composition by dual X-ray absorptiometry scan, hormone and lipid assays will be performed to~     monitor metabolic effects of each treatment group. We hypothesize that increasing~     testosterone levels would increase lean mass, decrease fat mass and improve insulin~     sensitivity. We further hypothesize that improvements in the metabolic profile would decrease~     with anastrazole and improve with dutasteride, given in conjunction with T administration.~   "
197091|NCT00983541|"~     OBJECTIVES: This study proposes to evaluate the feasibility of delivery of this treatment in~     terms of toxicity. If toxicity is not acceptable, the treatment is not feasible.~      Primary Objectives~        -  To establish a preliminary assessment whether toxicity rates are acceptable in patients~          with locally advanced intra or extrahepatic cholangiocarcinoma when treated with a~          regimen of gemcitabine every two weeks and continuous fluorouracil (5-FU) given~          concurrently with external beam radiation therapy to a total dose of 45 gray(Gy),~          followed by a brachytherapy or Stereotactic Body Radiation Therapy(SBRT) boost.~      Secondary Objectives~        -  To evaluate the overall survival rate, progression free survival rate, tumor response~          rate, local control rate and the rate of distant metastases following gemcitabine and~          continuous 5-FU concurrent with radiation therapy in patients with locally advanced~          intra or extrahepatic cholangiocarcinoma.~        -  To evaluate the rate at which patients with unresectable extrahepatic cholangiocarcinoma~          become resectable following gemcitabine and radiation therapy.~   "
197092|NCT00983528|"~     Clofarabine is approved by the FDA for the treatment of pediatric patients (1 to 21 years of~     age) with relapsed or refractory ALL. Alemtuzumab is approved by the FDA for treatment of~     B-cell chronic lymphocytic leukemia (B-CLL) in patients over the age of 18. These drugs have~     been used to treat patients with leukemia in other research studies like this one. Both drugs~     have individually been administered to adult patients with ALL with acceptable toxicity~     profiles. This study will evaluate the combination of clofarabine and alemtuzumab when~     administered to adult patients with relapsed or refractory ALL. Primary objectives of the~     study is to determine the maximum tolerated dose of clofarabine when administered with~     alemtuzumab, evaluate the safety of the combination, and assess for activity of the~     combination by evaluating response rate, effect on ALL progenitor cell population, and~     patients who are able to bridge to transplant.~   "
197093|NCT00983515|"~     Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism~     of colchicine. This study will evaluate the effect of multiple doses of ritonavir on the~     pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to~     evaluate the safety and tolerability of this regimen in healthy volunteers. All study~     subjects will be monitored for adverse events throughout the study period.~   "
197094|NCT00983502|"~     The investigators' long-term goal is to identify, and then provide general practitioners with~     evidence-based recommendations for therapeutic interventions for unexplained chronic fatigue~     (UCF). The investigators' central hypothesis guiding this application is that some~     complimentary and alternative medicine (CAM) practitioners have developed management~     approaches that are more helpful to patients with UCF than usual care.~   "
197095|NCT00983489|"~     The investigators hypothesize that counseling of mothers will increase exclusive breast~     feeding rates at six weeks postnatal age. In developing countries like India,there is~     shortage of staff and the number of newborns cared is huge. So counseling of mothers for~     breast feeding becomes difficult. In such a situation using audio-visual aids may be a more~     practical option to increase breast feeding rates. Therefore the investigators will compare~     the use of video demonstration with counseling for exclusive breast feeding.~   "
197096|NCT00983476|"~     Obesity and physical inactivity have reached epidemic proportions, resulting in increased~     rates of a variety of chronic diseases, increased risk of death, and substantial health care~     costs. Individuals with serious mental illness are even more likely to be overweight or~     obese, which contributes to the high rate of co-morbid medical disease and early mortality~     found among this population. Specific individual and group-based psychoeducational~     interventions have repeatedly and consistently been shown to help adults with serious mental~     illness improve their weight. However, these require substantial time from mental health~     clinicians, and frequent visits by patients to mental health clinics. This creates challenges~     for patients who may need to travel to a medical center that provides these services, and who~     often have limited transportation options. It is likely that these barriers can be addressed~     with a computerized, web-based intervention focused on diet and exercise education, and~     tailored for veterans with serious mental illness. Web-based systems can deliver content that~     is intensive, engaging, and tailored to the needs and preferences of specific patients.~     Web-based systems can be delivered using computers at community-based outpatient Clinics or~     other settings in the community. The objective of this project is to develop and evaluate the~     effectiveness of a web-based intervention to help patients with serious mental illness lose~     weight.~   "
197139|NCT00982917|"~     Playground injuries are common at childcare centers. Adequate adult supervision is an~     important component to reducing playground injuries in preschool children. The investigators~     studied the Stamp-in-Safety Program, an intervention to improve adult supervision and reduce~     children's risky playground behaviors.~   "
197097|NCT00983463|"~     Nonalcoholic fatty liver disease (NAFLD) is the most common type of liver disease in the~     United States. The incidence of NAFLD is very similar to that of obesity, type 2 diabetes,~     and the metabolic syndrome. The investigators hypothesize that there may be a relationship~     between over-nutrition, decreased physical activity and the development of fatty liver. The~     purpose of this study is to identify the types of fats and proteins, and the quantity of~     each, that are associated with increased severity of NAFLD.~   "
197098|NCT00983450|"~     The study will include 20 subjects who will be randomly divided to two groups: a ten person~     group being the study group and a ten person group acting as a control group (each group will~     include a similar number of females and males as the other group). In addition, the~     physiotherapy treatments at the rehabilitation center, the study group will gain an~     intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart~     of weekends). The intervention will include 6 minutes of watching a movie clip alternately~     showing a healthy man and a healthy woman at their sixties, walking while being filmed from~     various angles. Immediately after watching, the subject will perform 6 minutes of walking,~     under the experimenters supervision, but without his or hers intervention. Immediately~     following the walking, the whole procedure will be repeated (watching a clip and walking).~      The control group will undergo 12 treatments of the same nature, but will watch the movie~     clip shown backwards, so that the people filmed will seem to walk backwards (it was~     established that watching a reversed action does not activate the MNS system activated by a~     regular execution of the activity [Celnik et al., 2008]), followed by 6 minutes of walking~     under the experimenters supervision, then watching the movie again and walking again.~      The person performing the examinations will be blinded as to the division of the subjects to~     the study group and the control group. After performing the previously noted examinations~     needed to participate in the research, the subjects found fit will be examined before the~     beginning of the intervention, at its end and then three months after its conclusion. The~     examinations will include smart step and walking parameters.~   "
197099|NCT00983437|"~     The primary objective of this study is to evaluate the safety and tolerability of long-term~     (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild~     or moderate closed traumatic brain injury (TBI).~   "
197100|NCT00983424|"~     The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel~     and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells~     as well as or better than nab-paclitaxel alone.~   "
197101|NCT00983411|"~     The investigators hypothesized that increasing non intentional leaks could increase work of~     breathing and could lead to patient/non-invasive ventilation (NIV) asynchrony.~      The main objective is to compare ventilatory pattern (work of breathing, flow, pressure)~     under NIV with and without non-intentional leaks in 10 awakened healthy subjects and 10~     awakened and asleep obese hypoventilation syndrome (OHS) patients.~      Methods: While the subjects will be under NIV, several levels of leaks will be simulated in a~     random order with an automatically opening valve. Breathing pattern (work of breathing,flow,~     pressure, thorax and abdominal movements) will be recorded by Polygraphy. Healthy subjects~     will be recorded only during awakened state. OHS patients will be recorded both during awake~     and sleep sates.~      Analysis: A repeated measures analysis of variance (ANOVA) will compare work of breathing~     according to the different levels of leaks.~   "
197102|NCT00983398|"~     This phase I/II trial studies the side effects and best dose of melphalan when given together~     with carboplatin, mannitol, and sodium thiosulfate, and to see how well they work in treating~     patients with recurrent or progressive central nervous system (CNS) embryonal or germ cell~     tumors. Drugs used in chemotherapy, such as melphalan and carboplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD)~     uses mannitol to open the blood vessels around the brain and allow cancer-killing substances~     to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing~     loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving~     melphalan together with carboplatin, mannitol, and sodium thiosulfate may be an effective~     treatment for recurrent or progressive CNS embryonal or germ cell tumors.~   "
197103|NCT00983385|"~     The main objective of the study is to evaluate the effectiveness, tolerability, and safety of~     tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back~     pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics.~     This is a clinical effectiveness trial designed to establish a link between anticipated~     clinical outcomes and the clinical practice by means of selected measures of clinical and~     subject-reported outcome.~      The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I~     or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride~     prolonged release (PR) treatment during defined periods of evaluation.~   "
197104|NCT00983372|"~     Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).~     Extended-release diltiazem (diltiazem ER) is a potent inhibitor of both CYP3A4 and P-gp. This~     study will evaluate the effect of multiple doses of diltiazem ER on the pharmacokinetic~     profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the~     safety and tolerability of this regimen in healthy volunteers. All study subjects will be~     monitored for adverse events throughout the study period.~   "
197105|NCT00983359|"~     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor~     and cause less damage to normal tissue.~      PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in~     treating patients with brain metastases~   "
197106|NCT00983346|"~     OBJECTIVES~        -  Primary: To evaluate the bone anabolic effect of bortezomib in patients with smoldering~          myeloma.~        -  Secondary: To evaluate the effect of bortezomib on the natural history of smoldering~          myeloma.~   "
197140|NCT00982904|"~     This study is aimed at assessing the tolerability and pharmacokinetic parameters of the~     fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental~     Trypanosomiasis infections, fexinidazole shows highly promising efficacy.~   "
197314|NCT00980512|"~     The primary goal of this study is to examine the fidelity and generalization of parenting~     effects of the KEEP foster parent training intervention as it is being delivered within a~     child welfare system of care by a community mental health provider.~   "
197107|NCT00983333|"~     This research focuses on communication practices between patients and health care~     professionals, like nurses, doctors, or physician assistants. The goal is to help improve~     communication about heart health issues.~      This pilot (or Beta) study is designed to test our ability to recruit an appropriate sample~     of participants, and determine our ability to deliver and evaluate the effects of a web-based~     intervention. The investigators hypothesize that exposure to the intervention will result in~     measurable changes in self-reported knowledge, attitudes and behavior regarding communication~     between patients and health care professionals.~      Participants in this research study are being recruited from the people who currently receive~     care at the Richmond Family Health Center of the Oregon Health & Science University. People~     who participate in this study will be between 55 and 70 years old, speak English as their~     preferred language, and have one of several possible diagnoses related to heart health. These~     could include, for example, hypertension, diabetes, asthma, or obesity.~      Additionally, the investigators are recruiting a small number of health care professionals~     from the Richmond Family Health Center. Their participation will be similar to but separate~     from the participation of patients.~      All participants will take two web-based surveys. Some participants will use a web-based tool~     that hopes to help improve communication between health care professionals and patients.~      The surveys contain questions that explore the knowledge, attitudes, and behaviors of~     participants related to heart health and communication between health care professionals and~     patients.~      Data analysis will focus upon identifying any changes that occurred in knowledge, attitudes,~     or behaviors with respect to health communication after using the web-based tool, as well as~     learning about what influences the quality and nature of communication between health care~     professionals and the patients they serve.~   "
197108|NCT00983320|"~     This is a double-blind, randomized, placebo-controlled trial measuring the impact of~     quetiapine on clinical and experimental measures of pain in fibromyalgia and its biochemical~     correlates.~   "
197109|NCT00983307|"~     It is generally accepted that the presence of chronically hypoxic cells, or tumor cells which~     do not receive enough oxygen as a result of tumor growth, may be an important cause of~     resistance to radiation therapy (RT) and resultant tumor recurrence, particularly in large~     tumors such as advanced non-small-cell lung cancer (NSCLC). Therefore, delivering a higher RT~     dose, as is done with hypofractionated RT, to the tumor may result in higher success rate.~      Erlotinib (Tarceva, previously known as OSI-774) is an orally active, potent, selective~     inhibitor of the Epidermal Growth Factor Receptor (EGFR) tyrosine kinase. A recently~     completed trial has shown that Erlotinib as a single agent significantly improves the~     survival of patients with incurable Stage IIIb/IV NSCLC who have failed standard therapy for~     advanced or metastatic disease. Therefore, Erlotinib is an approved medication for~     second-line therapy in lung cancer following prior chemotherapy.~      This is a Phase II clinical research study to assess the efficacy and toxicity of~     hypofractionated radiation therapy in combination with Erlotinib in patients with locally~     advanced or inoperable non-small-cell lung cancer (NSCLC).~      The investigators' hypothesis is that the addition of erlotinib to RT will result in~     radiosensitization, therefore increasing the likelihood of local tumor control over RT alone.~     Maintenance erlotinib upon RT completion will result in further tumor growth inhibition, both~     systemically and locally, lengthening disease-free survival and overall survival.~   "
197110|NCT00983294|"~     Azithromycin is a possible weak to moderate inhibitor of CYP3A4, one of the enzymes~     responsible for the metabolism of colchicine. This study will evaluate the effect of multiple~     doses of azithromycin on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A~     secondary objective is to evaluate the safety and tolerability of this regimen in healthy~     volunteers. All study subjects will be monitored for adverse events throughout the study~     period.~   "
197111|NCT00983281|"~     This is a chart review of all trauma patients during the specified time period. The purpose~     of this study is to examine the effects of resuscitation with hextend after trauma, in the~     adult population. The authors hypothesize that when compared to patients resuscitated with~     standard of care, resuscitation with Hextend will result in a mortality difference.~   "
197112|NCT00983268|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving capecitabine~     and vorinostat together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when~     given together with capecitabine and radiation therapy in treating patients with~     nonmetastatic pancreatic cancer.~   "
197113|NCT00983255|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     single rising and multiple rising IV doses of TR-701 FA and to determine the absolute~     bioavailability of oral TR-701 FA following single oral and IV dose administrations in~     healthy adult subjects.~   "
197114|NCT00983242|"~     Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).~     Verapamil hydrochloride is a potent inhibitor of cytochrome P450 (CYP) 3A4 and P-gp. This~     study will evaluate the effect of multiple doses of extended-release verapamil hydrochloride~     (verapamil HCl ER) on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A~     secondary objective is to evaluate the safety and tolerability of this regimen in healthy~     volunteers. All study subjects will be monitored for adverse events throughout the study~     period.~   "
197115|NCT00983229|"~     Various supraglottic airways may be used as a dedicated airway for insertion of intubating~     fibrescope and tracheal intubation in the patients with difficult to manage airways~     (Difficult Airway Society Guidelines).~      The investigators aim to compare three different types of supraglottic device as a conduit~     for tracheal intubation - CTrach optical laryngeal mask, Intubating laryngeal mask airway and~     I-gel supraglottic airway. Null hypothesis for this study is that all three devices will~     perform without statistical difference in the means of success rate and time needed for their~     insertion and tracheal intubation.~   "
197116|NCT00983216|"~     Ketoconazole is a potent inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the~     enzyme systems responsible for the metabolism of colchicine. This study will evaluate the~     effect of multiple doses of ketoconazole on the pharmacokinetic profile of a single 0.6 mg~     dose of colchicine. A secondary objective is to evaluate the safety and tolerability of this~     regimen in healthy volunteers. All study subjects will be monitored for adverse events~     throughout the study period.~   "
197117|NCT00983203|"~     The purpose of this study is to describe the acute comfort and haze profile of FID 114657 in~     dry eye patients.~   "
197172|NCT00982488|"~     This study assesses the long-term safety and tolerability of dasatinib administered to~     patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute~     lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or~     imatinib in previous protocols.~   "
197118|NCT00983190|"~     Study Purpose~      The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non~     transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium~     and the Netherlands are equivalent to or better than published results in the scientific~     literature with approved devices. Implants will be performed following the HeartMate II~     guidelines.~      Characterization of Patient Population The HeartMate II will be implanted as destination~     therapy in patients who are not candidates for cardiac transplantation.~      Study Design~      The study is a prospective, non-randomized, non-blinded multi-center study with historical~     control. The study will consist of the assignment of eligible patients to treatment with the~     LVAD. The first 10 patients to have the device implanted will be enrolled in the study.~      Study End point~      Patients enrolled in the study will be followed until end points defined as death, 2-year~     support on the HeartMate II, device removal, transplantation, or recovery.~      Data Collection and Follow-up~      All data will be entered into INTERMACS® through their web-based data entry system. All data~     for the BeneMACs study will be held separately from the main INTERMACS database, and used~     only for the purpose of the BeneMACs study.~      Investigator sites~      Cliniques Universitaires St. Luc, Avenue Hippocrates 10, 1200 Brussels, Belgium Leuven~     Gasthuisberg University Hospital, Herestraat 49, 3000 Leuven, Belgium~   "
197119|NCT00983177|"~     Chronic pain due to calcific tendonitis of shoulder is a prevalent condition usually treated~     with recurrent courses of NSAIDs, physical therapy or surgical interventions. Colchicine has~     been reported to be effective in the acute attack of shoulder tendonitis, however, has never~     been examined in controlled study in patients with chronic shoulder pain secondary to~     calcific tendonitis. Eighty patients with chronic shoulder pain (at least 3 months duration)~     due to calcific tendonitis will be randomized to receive colchicine 0.5 mg twice daily or~     placebo (lactose capsules) for 4 months. At the end of this blinded part of the study,~     patients who received placebo and did not improve, will be eligible to continue study in the~     open mode for additional 4 months with study drug. Efficacy (VAS for shoulder pain, shoulder~     range of motion and shoulder pain and disability index) and safety (blood tests) follow-ups~     will be scheduled bi-monthly for all patients.~   "
197120|NCT00983164|"~     The objective of the present study is to evaluate the antioxidant status in the blood of HCV~     patients treated with pegylated interferon (2a 1.5 ug/kg; 2b 180 ug) combined with ribavirin~     (1000 to 1250 mg) before and after supplementation of vitamins E, C and the mineral zinc (800~     mg,500 mg and 40 mg; respectively) during six months.~   "
197121|NCT00983151|"~     The purpose of this clinical trial is to test an experimental drug therapy called Tramadol~     Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) (Tramadol HCl ODT or the study~     drug). The subject and his partner are being asked to be in this clinical trial because they~     have a condition called premature ejaculation.~   "
197122|NCT00983138|"~     This non-controlled multicentre phase II study is designed to assess the safety and to~     describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase~     (rASNase) for first-line treatment of infants (< 1 year of age at diagnosis) with de novo~     acute lymphoblastic leukaemia~   "
197123|NCT00983125|"~     In a prospective randomised study involving primiparous women in spontaneous uncomplicated~     labour with cervical dilatation < 5 cm, epidural analgesia will be given with an initial~     volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual~     injections to achieve analgesia, then by a patient-controlled regimen with 5-mL~     self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic~     solution will be levobupivacaine presented in 100-mL bags from the market (0.0625%), in which~     10 mL (50 g) of sufentanil will be added, as well as clonidine (150 µg) in one arm. The final~     concentration of clonidine in this arm will be 1.35 mg.mL-1. Parturients and midwifes~     assessing pain during labour will be blinded to the design.~   "
197124|NCT00983112|"~     Knee prothesis surgery is responsible of a risk of thrombosis and hemorrhage. To prevent~     thrombosis, patients have systematic anticoagulation after surgery which are responsible of~     hemorrhage. A local glue which improve local coagulation and have no impact of thrombosis can~     be a solution to limit hemorrhage. The purpose of this trial is to study the impact of a~     biological glue administration on the bleeding loss at five days after a total knee~     prosthesis surgery operation.~   "
197125|NCT00983099|"~     Part 1 (single dose)~      Primary parameters~        -  Area under the plasma concentration curve from zero to infinity [AUC0-inf] and observed~          maximum plasma concentration [Cmax] of Japanese and Caucasian subjects for each dose~          group~        -  If at least 20% of the Japanese or of the Caucasian subjects have an area under the~          plasma concentration curve extrapolation [AUCextrap%] >20% relative to AUC0-inf for one~          of the dose groups area under the plasma concentration curve from zero to the last~          measurable concentration [AUC0- tz] becomes primary parameter for Japanese and Caucasian~          subjects for all of the dose groups. In this case AUC0-tau will become a secondary~          parameter~      Secondary parameters and derived values from statistical analysis~        -  Dose proportionality and linearity in Japanese subjects~        -  Ratios (Japanese vs. Caucasian subjects) of AUC0-∞ and Cmax for each dose group~        -  Dose normalized AUC [AUC0-inf,norm], dose normalized Cmax [Cmax,norm], AUC0- tz, time of~          occurrence of Cmax [tmax], apparent terminal half life [t½], mean residence time [MRT],~          apparent (oral) total plasma clearance [CLtot/f], apparent volume of distribution during~          the terminal disposition phase [Vz/f], AUCextrap%, apparent terminal disposition rate~          constant [λz], weight corrected AUC0-inf, weight corrected AUC0-tz, weight corrected~          Cmax, weight corrected CLtot/f, cumulative amount of excreted Neramexane into urine~          [Ae0-tz], fraction of orally administrated drug excreted into urine [fe/f], renal~          clearance [CLR] and apparent non-renal clearance [CLNR/f]~        -  Safety and tolerability~      Other parameters~        -  Pharmacogenetics~        -  Amount of N-OH Neramexane excreted in urine [Ae0-tz] if a validated method will be~          available at the time of analysis~        -  Metabolite determination (N-OH Neramexane) in plasma and urine, optional (may be~          analyzed and evaluated if a validated method will be available at the time of analysis)~        -  Endogenous creatinine clearance [CLCR], amount of excreted creatinine into urine per~          hour [AeCR,hr]~        -  Evaluation of further metabolites will be described in detail in the Statistical~          Analysis Plan~   "
197137|NCT00982943|"~     During the past decade, the dramatic change in patterns of both psychiatric diagnoses and~     prescription of psychotropic agents has been noted since the introduction of newer~     antidepressant drugs. In the meantime, suicide has been recognized as a major public health~     problem all over the world. Research efforts have hence been spent in exploring the~     interrelationships between suicide rates and prescription of antidepressant drugs (as a proxy~     for the treatment of depression). However, most available studies came from developed~     countries despite that the majority of countries with rising suicide rates during the past~     decade were developing countries. Both suicide rates and prescription of antidepressant~     agents have been rising in Taiwan during the past decade; with a reliable mortality registrar~     and nationwide health insurance covering 99% of its population, Taiwan is distinctive in~     realizing a large-scale analysis on these interrelationships between suicide and prescription~     of antidepressant drugs. However, there has been no study in Taiwan exploring these potential~     associations up to now.~      This study aims at examining the interrelationships between suicide rates and prescription of~     antidepressant agents based on the health insurance data from persons who had diagnoses of~     ICD: 290-319 or were prescribed with antidepressant agents during the period from 1998 to~     2006. The investigators plan to first perform correlation analyses between the trends of~     suicide rates and prescription of antidepressants during the study period after taking into~     accounts potential confounding factors; analyses by age, gender groups and by administrative~     regions will also be performed. Besides, the investigators plan to analyze the change in the~     prescription pattern of psychotropic agents in Taiwan during the study period, with the~     particular focus on that of newer antidepressant drugs. The prescription of psychotropic~     agents in both psychiatric and non-psychiatric diagnoses will be explored.~   "
197126|NCT00983086|"~     Epidemiological studies have firmly established the health effects of high intakes of fruits~     and vegetables and in particular in regards to the prevention of cardiovascular diseases.~     Citrus fruits are the most widely consumed throughout the world, mainly as juice. Citrus~     fruits are rich in vitamin C but also in various plant micronutrients which are the most~     abundant polyphenols. Several in vitro studies and animal models suggest that the polyphenols~     of citrus are involved in the protective effects of citrus vis-à-vis the cardiovascular~     diseases. However, profits in health associated with taking these polyphenols are unknown and~     so far no clinical studies have been conducted to determine the contribution of polyphenols~     of citrus in this protection.~      The main objectives of this project are (1) to characterize the effects of single dose and~     made repeated consumption of orange juice on vascular protection and the immune response and~     (2) to assess the specific role of polyphenols present in citrus fruits in this protection.~     To do this the investigators will conduct a clinical study, randomized and crossover, among~     healthy men 50 to 65 years that are slightly overweight. These volunteers, who continue to~     follow their usual diet, should consume daily for 4 weeks (1) orange juice or (2) an~     isocaloric control beverage or (3) the same drink spiked with a dose of polyphenols similar~     to that given by orange juice.~   "
197127|NCT00983073|"~     The main objective of the study is to evaluate the effectiveness, tolerability, and safety of~     tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain~     due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or~     no regular analgesics. This is a clinical effectiveness trial designed to establish a link~     between anticipated clinical outcomes and the clinical practice by means of selected measures~     of clinical and subject-reported outcome.~      The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I~     or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride~     prolonged release (PR) treatment during defined periods of evaluation.~   "
197128|NCT00983060|"~     This is a study designed to identify a dose of NIM811 that has a good safety profile, is well~     tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral~     load reduction compared to SOC alone. This information will be used to support doses selected~     for future studies.~   "
197129|NCT00983047|"~     Nimotuzumab is a humanized monoclonal anti-body targeting the epidermal growth factor~     receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different~     indications. Nimotuzumab has demonstrated a unique clinical profile, where anti-tumor~     activity was observed in absence of severe skin, renal, gastrointestinal mucosa toxicities~     commonly associated with EGFR-targeting antibodies. Nimotuzumab has been granted approval for~     use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in~     many countries. The investigators compared docetaxel plus nimotuzumab with docetaxel alone in~     chemotherapy-refractory/resistant patients with advanced EGFR-positive non-small-cell lung~     cancer to assess the efficacy and safety.~   "
197130|NCT00983034|"~     Membranous nephropathy (MN) may also be secondary to many other diseases (e.g., infections,~     drugs, neoplasms and autoimmune diseases). In this study, the presence of Helicobacter Pylori~     (H. pylori) antigen was investigated in renal tissue from needle biopsy samples, and the~     prevalence of H. pylori infection and the effects of H. pylori eradication on proteinuria~     level in patients with MN will be investigated.~   "
197131|NCT00983021|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety, tolerability, level of drug exposure and effect of NN9068.~      The trial participants will be randomised to 4 different treatments in trial, receiving trial~     products in a pre-defined order.~   "
197132|NCT00983008|"~     This study will test the feasibility and effectiveness of protected time for physicians in~     training during 30 hour shifts in a medical intensive care unit. The primary outcome will be~     fatigue. Secondary outcomes include the amount slept while on call, depression, and burnout.~   "
197133|NCT00982995|"~     The primary objective of this study is to determine the complete response (no vomiting and no~     need for other medications to treat nausea) in terminally ill patients suffering from nausea~     and/or vomiting, who are treated with palonosetron. Another objective is to determine the~     partial response (relief of nausea and vomiting to the extent that the patient wishes to~     continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is~     currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy.~     The investigators are testing this medication to see if it can help to relieve nausea and~     vomiting not associated with chemotherapy.~   "
197134|NCT00982982|"~     The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or~     THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity~     of the brain (EEG). THC is the active ingredient of marijuana, cannabis, ganja, or pot.~     Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to~     determine whether the administration of iomazenil will alter the effects of THC.~   "
197135|NCT00982969|"~     The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the~     diagnosis of active tuberculosis in young adults group, highly clinically suspected~     tuberculosis.~   "
197136|NCT00982956|"~     Objective:~      The purpose of this study is to evaluate the application of computer-assisted navigation in~     Total Knee Arthroplasty (TKA ) by comparing it with conventional TKA.~      Methods:~      Gemini MK II implants (Link, Germany) were used. VectorVisionâ CT-free navigation system~     (BrainLab, Germany) was employed for the TKA. For each subject, computer-navigation TKA and~     the conventional TKA were separately performed on two knee joints. The operative method and~     order of the operations were decided on a randomized basis. All the patients and doctors~     conducting follow-up study and performing imaging measurement were blind to selection of the~     operation. Student t test was used for statistical analysis.~      hypothesis: computer-assisted navigation system can significantly improve the accuracy of~     tibial and femoral cuts on coronal and sagittal planes.~   "
197138|NCT00982930|"~     This is an open-label, single arm (uncontrolled) study in subjects suffering from cystic~     fibrosis, who have completed their study participation in CTBM100C2303 (all visits) and who~     were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.~   "
197173|NCT00982475|"~     Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients~     with drug refractory atrial fibrillation are not inferior to manual radiofrequency current~     ablation.~   "
197141|NCT00982891|"~     Chronic Obstructive Pulmonary Disease (COPD) affects at least 750,000 Canadians and is~     currently the 4th leading cause of death in Canada. Almost everyone with COPD suffers from~     shortness of breath (dyspnea) that worsens over time despite standard treatment (inhalers,~     exercise programs and oxygen). Patients and families have identified relief from dyspnea as a~     top priority for improved care. New approaches are needed for treating advanced COPD to~     lessen the burden that it places on the lives of patients and families alike. Opioid drugs,~     such as morphine, can help in COPD in many ways, including reducing dyspnea, fear and~     anxiety. Opioids are used widely in cancer for similar symptoms. However, there are~     historical biases against their use in advanced COPD (mostly due to fear of side effects when~     much higher doses than the investigators intend have been used in the past). No studies have~     assessed the value to patients of using low dose opioids in advanced COPD in addition to~     conventional treatment. The investigators are planning a study that involves recording~     interviews with about 30 patients and their partner or key family member before and after~     starting treatment with low dose morphine, to understand their experiences with using~     morphine. The investigators will also ask them to complete questionnaires about quality of~     life, dyspnea, anxiety, depression and fear. Descriptions of experiences of using morphine~     have the potential to inform patients, families, clinicians and professional societies about~     the benefits and harms of opioid use for dyspnea in the advanced stages of a common serious~     lung disease when traditional treatments often fail. The investigators will conduct the study~     in both urban (Halifax and Saskatoon) and in a rural setting (New Brunswick). The~     investigators' study of an inexpensive and widely available treatment has the potential to~     improve care and outcomes in advanced COPD for the many Canadians living and dying with this~     serious lung disease.~   "
197142|NCT00982878|"~     The purpose of this study is to describe the Central Nervous System exposure of maraviroc in~     HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at~     steady state.~   "
197143|NCT00982865|"~     This is a first in man trial with a primary objective being the determination of the Maximum~     Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK~     inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors~     to see how safe is treatment with MSC1936369B.~   "
197144|NCT00982852|"~     Patients enrolled will need treated with an IVUS- VH (intravascular ultrasound-derived~     virtual histology) which is an arterial stent procedure, that involves threading a tiny wire~     into the artery, followed by a balloon, a stent, or other device to treat a blocked artery,~     and often (though not always), a special ultrasound catheter to take pictures of the inside~     of the artery.~      Participants in the study, will have an additional procedure performed: a tiny tube will be~     advanced into the heart artery to collect a blood sample for research purposes, and a blood~     sample will be collected from the femoral (thigh) artery through the tube that will be placed~     there as a standard part of having this procedure.~      The blood that is collected will be analyzed for markers of inflammation or irritation in the~     blood (c-reactive protein, myeloperoxidase, Monocyte chemotactic protein-1), as well and a~     gene called Matrix Metallopeptidase 3, which is believe to influence the progression of~     plaque on the walls of arteries and the progression of coronary artery disease. .~   "
197145|NCT00982839|"~     At least 60% of patients with constipation and dyssynergic defecation (anismus) and between~     30-50% of patients with fecal incontinence exhibit impaired rectal sensation. The problem may~     be improved by biofeedback therapy. Traditionally, biofeedback therapy was performed by using~     a syringe-assisted technique. Although some respond to this method, many, particularly those~     with severe rectal hyposensitivity have proved to be refractory. Also, repeated inflation and~     deflation of a large volume of air, using a hand-held syringe is cumbersome and time~     consuming. Recently, in pilot observations, the investigators have seen that a~     barostat-assisted technique of biofeedback therapy was simpler and easier to perform and~     could possibly be more effective. The investigators' aims are:~        1. To perform a randomized controlled study that compares the syringe-assisted sensory~          conditioning (biofeedback therapy) technique with the barostat assisted sensory~          conditioning for improving the rectal sensation in patients with rectal hyposensitivity~          and bowel dysfunction.~        2. To investigate the impact of sensory conditioning on psychosocial issues and quality of~          life.~        3. To compare the cost-effectiveness of each therapeutic modality The specific hypotheses~          that will be tested are;~      When compared to those who receive syringe-assisted training, patients receiving barostat~     training will demonstrate:~        1. Lower sensory thresholds for rectal perception (first sensation, desire to defecate and~          urgency)~        2. Greater satisfaction with bowel function (VAS Score), stool frequency,consistency &~          straining.~        3. Better learning ability and greater ease of administering this training.~   "
197146|NCT00982826|"~     To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation~     administered as a single dose and then administered as multiple doses for 7 days. The effect~     of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be~     evaluated.~   "
197147|NCT00982813|"~     The aim of the study is to determine the influence of the periodontal diseases in patients~     giving pre-term birth in the maternity hospital of Nantes. A French population is observed.~     The clinical, bacteriological and microbiological aspects will confirmed a comparative study~     which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.~   "
197148|NCT00982800|"~     The Acute Pain Service (APS) at Sunnybrook has been using Gabapentin 200 mg three times a day~     (TID) resulting in anecdotal benefits in terms of analgesia and opioid sparing effects.~     Higher doses of Gabapentin were associated with an increased incidence of sedation. The~     purpose of the study is to investigate if Gabapentin 200 mg given three times a day for 72~     hours (9doses) results in a reduction in the total amount of opioid required after radical~     prostatectomy surgery as compared to placebo, and if analgesia is improved. This study will~     also examine the possible anxiety sparing effects and any health related quality of life~     (HRQL) changes, which may be a result of our perioperative use of gabapentin.~   "
197174|NCT00982462|"~     The hypothesis to be examined is that dietary LCP-supplementation in the second and third~     years of life will improve cognitive and visual maturation in early childhood.~   "
197175|NCT00982449|"~     This research is being done to determine whether viral thymidine kinase (TK) expression in~     Epstein-Barr virus (EBV) and Kaposi's sarcoma herpesvirus (KSHV) virus-associated tumors is~     sufficient to image.~   "
197176|NCT00982436|"~     The purpose of this study is to evaluate the effectiveness and safety of neoadjuvant~     chemotherapy (chemotherapy given before radiotherapy) using cisplatin and docetaxel, followed~     by carboplatin given at the same time as radiotherapy in the treatment of locally advanced~     head and neck cancer.~   "
197315|NCT00980486|"~     The purpose of this study is to determine whether the dose of prophylactic antibiotics at the~     time of cesarean delivery requires adjustment in obese and overweight patients in order to~     achieve optimal antimicrobial activity.~   "
197149|NCT00982787|"~     The purpose of the Phase II clinical trial will be to see if a botanical extract from the~     plant Passiflora incarnata can improve seizure control and reduce anxiety in patients~     diagnosed with partial epilepsy.~      The investigators will randomize approximately 25 participants with partial epilepsy for this~     placebo controlled, double blind, and crossover study. All patients will be scheduled for 10~     clinic visits and four telephone visits during the 32-week period of the trial. After~     enrollment into the study, all participants will begin a 9-week observation phase, which~     serves as an individual baseline control. After 9 weeks participants will be randomized to~     receive either study drug or placebo for an 11 week study period. After completion of the 11~     week study period, patients will crossover to the other study drug/placebo arm for another 11~     weeks. Epilepsy participants will continue taking their anti-epileptic medication as~     currently prescribed. The investigators will find participants through the OHSU clinics, by~     notifying local neurologists, anthroposophical and naturopathic practices, and by advertising~     the study via the local chapter of the American Epilepsy Society.~      Routine blood tests, physical examinations and tests to monitor heart, brain and muscle~     activities will screen for any adverse effects. The primary outcome measure will be seizure~     frequency through seizure diaries. Attention and performance tests, neurological and quality~     of life questionnaires will be completed to assess the secondary outcome measures of anxiety,~     cognitive function and quality of life.~   "
197150|NCT00982774|"~     A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety,~     tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given~     at 14-day intervals as an adjunct to standard chemotherapy with sodium stibogluconate (20~     mg/kg/day for 40 days) in patients with PKDL.~   "
197151|NCT00982761|"~     The purpose of this study is to discover the health status of occupational drivers. The~     health status includes data collection of body mass index, blood pressure, central obesity,~     anxiety scale scores, smoking habit and related cessation therapy, etc.~   "
197152|NCT00982748|"~     The purpose of this study is to determine the feasibility and efficacy of yoga breathing~     techniques to manage fatigue and other cancer-related side effects, in cancer patients~     undergoing chemotherapy.~   "
197153|NCT00982735|"~     The CONTROL study is an out patient based prospective observational cohort study. The main~     aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day~     under real life conditions in usual clinical practice in essential hypertensive patients in~     the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24~     weeks.~   "
197154|NCT00982722|"~     A randomised double blind clinical trial, accepted by the Medical Products Agency and~     registered in the European Clinical Trials Database. Aims to evaluate the prevalence of~     vitamin D deficiency in a pHPT population in relation to gender and age, the correlation~     between vitamin D status, pre- and postoperative parathyroid hormone level and bone density~     and the correlation between vitamin D status, metabolic, cardiovascular risk factors and QoL~     aspects before and after parathyroid adenomectomy.~   "
197155|NCT00982709|"~     Aim:~      To determine the Responsiveness of the iMOBILITY in response to intensive physical therapy~     exercise programs. (Is it sensitive to change?) Although exercise is thought to be the most~     effective intervention for balance and gait in PD (compared to dopaminergic medication or DBS~     surgery), the best exercise program for mobility in PD is unknown. The iMOBILITY will be used~     to quantify balance and gait performance before and after two PT-supervised, intensive,~     exercise programs, expected to improve balance and gait. The first program is a published~     Treadmill training program and the second is the investigators new Agility training program~     with sensorimotor progressions, targeted at specific impairments that underlie the~     abnormalities of balance and gait in PD (developed for the Kinetics Foundation). This pilot~     clinical trial will randomize 40 PD subjects into the two exercise programs at OHSU in~     preparation for a larger clinical trial to determine the most effective exercise for mobility~     disability in PD. The effects of exercise will be compared with no treatment during a 5-week~     delay prior to start of exercise.~      This trial will also determine the relative responsiveness (compared to traditional clinical~     scales) of the iMOBILITY for testing the hypothesis that intensive exercise can improve~     mobility in PD. We will use existing instruments (Berg Balance Scale, BEST of dynamic~     balance, UPDRS, PDQ-39, 5 times sit-to-stand time and the Functional Performance Battery) to~     show there is a difference between the exercise groups. Superior responsiveness of the~     iMOBILITY system will be determined by larger differences with exercise intervention with the~     iMOBILITY system than with traditional clinical measures of mobility in PD.~   "
197156|NCT00982696|"~     This study will investigate the efficacy of opioid growth factor (OGF) on tumor size and~     survival in patients with head and neck cancer who have failed standard therapy.~   "
197157|NCT00982683|"~     The potential influence of lunar phases on human life has been widely discussed by the lay~     press. The purpose of this study was to evaluate a possible relation between the lunar cycle~     and the hemorrhagic complication rate and surgical outcome.~      PATIENTS AND METHODS:~      The investigators tested this hypothesis by evaluating the complication rate for 18760~     patients who underwent surgery from January 2001 to December 2008 (103 lunar phases) at the~     National Institute for Cancer Research in Genoa.~      The date of definitive surgery was allocated to the lunar phases.~   "
197158|NCT00982670|"~     An increased prevalence of the metabolic syndrome has been found in patients with systemic~     lupus erythematosus in recent years.~   "
197159|NCT00982657|"~     The safety and tolerability of CVX-060 have been established in the first-in-human clinical~     trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics~     (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and~     to subsequently assess the treatment efficacy of the combination treatment, as well as that~     of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).~   "
197177|NCT00982423|"~     The investigators' objective is to define the effects of decreasing the furosemide dose on~     heart, kidney and humoral function in people with compensated heart failure and kidney~     dysfunction and also in people with compensated heart failure without kidney dysfunction.~     Secondly, to define the humoral activation in both groups.~   "
197348|NCT00980005|"~     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     investigational vaccine GSK1557482A.~   "
197160|NCT00982644|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in~     subjects with type 2 diabetes never treated with insulin followed by the extension trial~     investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin~     glargine in subjects with type 2 diabetes.~      All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant~     enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl~     peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment~     is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor~     treatment is also discontinued). Subjects who consent to participate in the extension trial~     will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to~     which they were randomly allocated in the 52 week main trial.~      The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension~     period is registered as NN1250-3643.~   "
197161|NCT00982631|"~     A study to examine the combination of temsirolimus and Caelyx® (chemotherapeutic) in advanced~     or recurrent breast, endometrial and ovarian cancer.~   "
197162|NCT00982618|"~     This is a blinded randomized controlled trial in patients undergoing laparoscopic colon~     surgery. The aim of this study is to assess whether perioperative intravenous lidocaine has~     an impact on the early post operative physical activity recovery of patients scheduled for~     laparoscopic colon surgery.~      Twenty patients will receive thoracic epidural analgesia, twenty patients will receive~     intravenous lidocaine plus patient-controlled analgesia (PCA) and twenty patients will~     receive only PCA.~      Hypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery~     will be faster and decrease pain intensity, opioid consumption and side effects, length of~     hospital stay; probably as a result of a significant opioid sparing and attenuated~     inflammatory response.~   "
197163|NCT00982605|"~     The purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of~     non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle~     aspiration (EBUS-TBNA).~   "
197164|NCT00982592|"~     This randomized phase II trial studies combination chemotherapy when given together with~     vismodegib to see how well it works compared with combination chemotherapy without vismodegib~     in treating patients with advanced stomach cancer or gastroesophageal junction cancer. Drugs~     used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells. Vismodegib may stop the growth of~     stomach or gastroesophageal junction cancer by blocking the growth of new blood vessels~     necessary for tumor growth. It is not yet known whether combination chemotherapy is more~     effective when given with or without vismodegib in treating stomach cancer and~     gastroesophageal junction cancer.~   "
197165|NCT00982579|"~     Objectives:~      Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to~     HIV-1/2-uninfected mothers.~      Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV)~     when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine~     within the first 4 weeks of life.~   "
197166|NCT00982566|"~     This is a randomized, single dose, open-label, multicenter crossover study to determine the~     oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263~     formulation being administered in ongoing Phase 1/2a studies. Approximately 48 evaluable~     subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors~     will be enrolled in this study.~   "
197167|NCT00982553|"~     The purpose of this study is to look at levels of both a new anti-HIV drug called raltegravir~     and an existing anti-hepatitis C drug called ribavirin to see if they affect the blood levels~     of each other when given separately and together. This is a phase I, open-label, prospective,~     three phase, pharmacokinetic study.~   "
197168|NCT00982540|"~     The main objective of this study is to test prospectively the performance of an algorithm~     stratified by an index based on neutrophil counts in association with galactomannan assay and~     image tests to start an antifungal early therapy (empirical/preemptive) in neutropenic~     patients. Ths specific objectives are to determine the overall incidence of invasive fungal~     infections, use of antifungal agents, duration of hospitalization and mortality in this~     cohort, and to evaluate if this strategy is associated with a reduction in the expected use~     of antifungal agents if a classical empiric antifungal strategy was used, without an increase~     in the incidence of invasive fungal infections.~      This is a prospective, non randomized, non comparative study. Patients aged ≥ 18 years are~     eligible if they have acute leukemia, myelodysplasia or other baseline disease submitted to~     chemotherapy or to allogeneic stem cell transplantation with an expected duration of~     neutropenia (neutrophil count <500cells/mm³) of at least 10 days. Exclusion criteria are~     patients with and a past history of or invasive mold infection and those who do not want to~     participate. The study has no comparator arm. However, the investigators intend to determine~     if the algorithm based on the D-index would result in a 50% reduction in the use of~     antifungal agents, if all patients with persistent fever and neutropenia received empiric~     antifungal therapy. Based on our database of ~2,000 episodes of febrile neutropenia, 36% of~     patients had persistent fever between days 4 and 7 of antibiotics and would receive empiric~     antifungal therapy. A total of 105 patients will be needed to demonstrate a 50% reduction in~     antifungal use if the investigators compared this cohort with a matched control historical~     cohort (alpha = 5%, beta = 20%).~   "
197169|NCT00982527|"~     The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary~     bypass in young children with congenital heart disease is able to reduce indicators of acute~     kidney injury (biomarkers reduction, diuresis increase) compared to a control group.~   "
197170|NCT00982514|"~     The study will examine the prevalence of venous thromboembolism in children with acute~     lymphoblastic leukaemia treated in accordance with NOPHO ALL-2008. The investigators will~     prospectively study clinical symptomatic thromboses, asymptomatic central line-associated~     thromboses, and infections.~   "
197171|NCT00982501|"~     The purpose of this study is to test:~        1. Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9~          kg/m²)~        2. Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking~          training in overweight subjects~   "
197178|NCT00982410|"~     The proposed project will provide crucial data on the effectiveness of a pain management~     intervention designed for veterans with co-occurring pain and substance use disorders. The~     development of an empirically validated psychosocial intervention for managing pain and~     substance misuse could greatly enhance the current set of options for treating this large and~     understudied group of veterans.~   "
197179|NCT00982397|"~     The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system~     performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate~     at one year of subjects implanted with a Medtronic Protecta implantable cardioverter~     defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be~     evaluated.~   "
197180|NCT00982384|"~     The purpose of this study is to determine whether comprehensive disease management program~     combined with best care recommended in clinical guidelines, is more effective than best care~     alone in patients with advanced chronic obstructive pulmonary disease (COPD).~   "
197181|NCT00982371|"~     The number of people with type 2 diabetes is growing. This puts a lot of pressure on the~     health care systems. Type 2 diabetes is often associated with health problems, like poor~     eyesight, muscle coordination, muscle strength, and blood flow. Poor bone health may also be~     a concern for people with type 2 diabetes.~      A large proportion of people with type 2 diabetes will break a bone in their lifetime. The~     risk of this happening in older people with type 2 diabetes is greater than the risk in older~     people without diabetes. Fracturing a bone can be very painful, and lead to serious~     consequences, especially if the individual experiences a hip fracture. The elevated fracture~     risk, seen in those with type 2 diabetes, is puzzling because people with type 2 diabetes~     often appear to have normal, healthy bones compared to people of the same age without~     diabetes.~      Bone micro-structure, which is not assessed by traditional bone densitometry systems (ie:~     DXA) contributes to overall bone strength.~      The hypothesis of this study is that bone micro-structure is of poorer quality (reduced~     trabecular thickness, increased trabecular spacing) in postmenopausal women with type 2~     diabetes, compared to age-matched control participants.~   "
197182|NCT00982358|"~     This study is designed to support the use of valsartan in the diabetic population. Two~     different groups will be studied, one with and one without coronary artery disease (CAD)~     documented by angiography.~      The study is intended to demonstrate that valsartan 320 mg has an anti-inflammatory~     potential, reducing inflammatory serum markers as well as inflammatory gene expression, and~     to show that valsartan is able to improve metabolic parameters in this patient population.~     Furthermore, in the subgroup of patients with documented CAD this study wants to show that~     valsartan improves coronary perfusion.~      3 Objectives~      Primary objectives:~        1. To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the~          hypothesis of superiority compared to placebo in the reduction of the inflammatory~          marker Tumor necrosis factor alpha (TNFα) in plasma after 16 weeks of treatment in~          hypertensive patients with type 2 diabetes mellitus.~        2. To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the~          hypothesis of superiority compared to placebo in the reduction of the inflammatory~          marker Interleukin 6 (IL-6) in plasma after 16 weeks of treatment in hypertensive~          patients with type 2 diabetes mellitus.~      Secondary objectives:~        1. To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.~        2. To explore the effect of 160/320 mg valsartan on additional inflammatory markers in~          plasma [e.g. C-Reactive protein (CRP), soluble intracellular adhesion molecule-1~          (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), serum amyloid A (SAA),~          soluble CD40 ligand (sCD40L), fibrinogen, Interleukin 1β (IL-1β), matrix~          metalloproteases -2, -3 and -9 (MMP-2, -3, -9), and sE-selectin)].~        3. To explore the effect of 160/320 mg valsartan on inflammatory gene expression from~          monocytes and fat tissue.~        4. To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat~          tissue.~        5. To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of~          patients with angiographically documented CAD.~   "
197183|NCT00982345|"~     The purpose of this study is to find out what parts of the brain have increased or decreased~     connectivity when people are depressed and how Seroquel extended release (XR) changes this~     connectivity in depressed patients. The genetic samples collected are to look at variation in~     a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin~     in the brain.~   "
197184|NCT00982332|"~     The study will examine the efficacy of a single intramuscular injection of betamethasone~     dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml)~     as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be~     randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution)~     immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy,~     starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the~     disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome~     measures: the total cumulative dose of glucocorticosteroids and disease duration.~   "
197185|NCT00982319|"~     The purpose of this research is to examine the effect of a broccoli sprout preparation on~     specific factors in breast tissue that are related to breast cancer risk and to assess~     whether sulforaphane a key component of broccoli sprouts increases the levels of protective~     enzymes in breast tissue. In addition, the investigators will also examine how acceptable the~     broccoli sprouts preparation is to the study participants.~   "
197186|NCT00982306|"~     Alcohol abuse is a widespread concern internationally with a significant threat to world~     health. Research suggests a relationship between heavy drinking and certain clinical~     presentations such as injuries, physical and psychiatric illnesses and frequent sickness~     absence from employment. This research aims to establish whether brief interventions~     delivered to harmful and hazardous alcohol drinkers admitted to hospital impacts of their~     alcohol consumption levels on discharge from hospital.~   "
197187|NCT00982293|"~     The purpose of this study is to see if using a device called the Resonator, that puts out~     very low level electromagnetic fields, effects blood glucose and A1c levels in people with~     Type 2 Diabetes.~   "
197188|NCT00982280|"~     The main objective of the study is to evaluate the effectiveness, tolerability, and safety of~     tapentadol hydrochloride prolonged release (PR) in participants suffering from severe chronic~     pain due to osteoarthritis of the knee who are taking WHO Step III analgesics and show lack~     of tolerability. This is a clinical effectiveness trial designed to establish a link between~     anticipated clinical outcomes and the clinical practice by means of selected measures of~     clinical and subject-reported outcome. The trial will compare the effectiveness of previous~     analgesic treatment (WHO Step III) with that of tapentadol hydrochloride PR treatment during~     defined periods of evaluation.~   "
197189|NCT00982267|"~     The purpose of this study is to define the Maximum tolerated dose of SU14813 when~     administered as single agent in patients with solid tumors.~   "
197190|NCT00982254|"~     This study compared the pharmacokinetic and pharmacodynamic properties of an oral insulin~     formulation with that of a standard subcutaneous injection of regular human insulin.~   "
197873|NCT00973024|"~     The purpose of this study is to compare the safety and effectiveness of different doses of~     JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain~     patients with a diagnosis of chronic low back pain.~   "
197191|NCT00982241|"~     The researchers want to investigate how fluid intake influences the symptoms of OAB. The~     researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups~     (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while~     filling in an standard micturation diary for 2 days. This micturation diary is coupled to:~     collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of~     Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine~     samples will be analysed for osmolality by the clinical chemistry department.~   "
197192|NCT00982228|"~     This trial is conducted in Africa, Europe and the United States of America (USA).~      The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue~     (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients~     with type 1 diabetes.~      The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension~     period is registered as NN1250-3644.~   "
197193|NCT00982215|"~     Paracetamol is the centrally acting analgesic most commonly used in the world, indicated for~     the symptomatic treatment of fever and pain in mild to moderate. It comes in different~     formulations for oral, intravenous and rectal. The IV route allows rapid passage of~     paracetamol in the systemic arterial circulation and thus the brain, faster distribution~     evidenced a higher plasma concentration compared with oral and rectal. However the IV route~     also has disadvantages well known risks iatrogenic perfusion is an invasive lengthy,~     unpleasant and painful.~      The way per-Albus not to date used for the administration of paracetamol. It is a path~     nonetheless very interesting for the rapid absorption of drugs such as nitrates used in~     angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival~     groove) and allows a very rapid action. Furthermore, the terminal per-oral mucosa, less~     restrictive than IV administration and faster than oral administration, requires a simple~     medical gesture without special surveillance after administration, produces no pain or risk~     of infection for the patient (in contrast to the IV). It is interesting to test a new dosage~     form per-oral mucosa of paracetamol and compare pharmacological level (pharmacokinetics and~     pharmacodynamics) with the only dosage form of reference used by the IV route.~   "
197194|NCT00982202|"~     This study was designed to assess the safety and tolerability of pioglitazone, an approved~     drug for type 2 diabetes, in non diabetic patients with Alzheimer's disease. It was also~     designed to generate preliminary information on whether pioglitazone might slow progression~     of Alzheimer's disease.~   "
197195|NCT00982189|"~     This study is funded by the American Heart Association. The goal of this research is to~     prevent early cardiovascular damage before symptoms develop for persons with HIV infection.~     Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces~     risk for heart disease in persons who are at increased risk (such as the case with HIV~     infection).~      Participants who are taking HIV treatment with an 'undetectable' viral load, and who do NOT~     need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants~     will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure~     medication (or a placebo), and will be seen at 3 study visits over 4 months.~   "
197196|NCT00982176|"~     The general purpose of the present pathophysiological study is to investigate the relation~     between cognitive impairment observed after an acute coronary syndrome and the presence of~     cerebral anatomo-functional abnormalities. This study will improve the investigators'~     understanding of the disease and will help in early diagnosis and prevention of vascular~     dementia in this population.~   "
197197|NCT00982163|"~     The study was designed to evaluate the pattern of seasonal allergic signs and symptoms~     consistent with ongoing ocular allergic inflammation during ragweed season. It was~     hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain~     subjects.~   "
197198|NCT00982150|"~     This will be an open label treatment extension phase in patients with ALS who have previously~     participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make~     talampanel treatment available to all subjects who completed the double blind~     placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider~     it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It~     will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.~   "
197199|NCT00982137|"~     The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the~     co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.~      Objectives:~      Safety:~        -  Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE~          administered concurrently, one month before or one month after STAMARIL® to adult~          volunteers (≥ 18 to ≤ 55 years) without prior Japanese encephalitis (JE) or yellow fever~          (YF) vaccination.~      Immunogenicity:~        -  Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE~          administered concurrently, one month before or one month after STAMARIL® to adult~          volunteers without prior JE (or YF) vaccination.~        -  Assess the durability of the immune response in adult volunteers 6 months after~          administration of ChimeriVax™-JE and STAMARIL®.~   "
197200|NCT00982124|"~     The investigators have currently finished conducting an international multi-center trial that~     compares the efficacy and safety of pamidronate and zoledronate in the treatment of moderate~     to severe forms of Osteogenesis Imperfecta (OI). This trial has included only children above~     one year of age. The aim of the current study is to extend the observations of that currently~     finished study to infants below 1 year of age. Moreover, it is possible to administer~     zoledronate in a single short infusion instead of the three-day cycles with Pamidronate,~     therefore decreasing patient and family burdens with shorter stays in the hospital.~   "
197201|NCT00982111|"~     The research study is testing the investigational drug necitumumab in the treatment of~     advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab,~     given together with a standard chemotherapy combination consisting of cisplatin and~     pemetrexed will be more effective in improving participant disease than the standard~     chemotherapy combination alone.~   "
197282|NCT00981032|"~     The investigators' aim is to implement an intervention to increase aspirin prophylaxis use~     among patients that is patient initiated, optimizes use of physician and staff time,~     appropriately compensates staff, provides clinicians with tools necessary for managing~     aspiring prophylaxis, and ensures continuous management.~   "
197202|NCT00982098|"~     Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative~     treatments are frequently utilized to reduce incontinence. However, their efficacy has not~     been completely investigated. In this study the investigators will compare the effect of an~     early rehabilitation programme (instruction of the patient, pelvic floor muscle training,~     electrical stimulation and biofeedback) versus instruction of the patient only.~      The investigators hypothesis is that early rehabilitation programme is more effective than~     patient's instruction alone in preventing urinary incontinence after radical prostatectomy.~   "
197203|NCT00982085|"~     The aim of this study is to evaluate the status of allergic diseases in the Korean military~     personnel.~   "
197204|NCT00982072|"~     The purpose of this study is to compare the effectiveness of tacrolimus (prograf) versus~     prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease.~   "
197205|NCT00982059|"~     The risk of colorectal cancer (CRC) is significant among cancer survivors treated with~     abdominal radiation therapy (RT). Further, CRC is once of the few cancers for which there is~     effective screening. Although some expert groups recommend early CRC screening for patients~     with prior abdominal RT, the effectiveness of early screening is unknown. It is also unknown~     if radiation-induced CRC passes through a pre-clinical phase in which precancerous polyps~     are detectable and treatable prior to becoming invasive cancers. This study will evaluate~     whether screening will detect pre-invasive colorectal polyps among survivors treated with RT.~   "
197206|NCT00982046|"~     The purpose of this study was to evaluate the clinical performance of three differing contact~     lens care solutions when used in conjunction with three contact lenses.~   "
197207|NCT00982033|"~     The primary objective of this study is to determine whether treatment with aliskiren (300 mg)~     compared to placebo will improve treadmill exercise time in older (age ≥ 55 years) patients~     with heart failure and normal ejection fraction (HFNEF).~   "
197208|NCT00982020|"~     Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years,~     with bipolar I disorder (manic or mixed episodes) or schizophrenia.~   "
197209|NCT00982007|"~     The main objective of this study is to demonstrate the efficacy and safety of an~     investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in~     subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to~     oral iron.~   "
197210|NCT00981994|"~     Inappropriate use of antibiotics to treat patients with acute bronchitis is a significant~     factor contributing to the selection of antimicrobial drug resistant pathogens, which~     threaten the effectiveness of available therapies to treat common community-acquired~     bacterial infections. A key factor driving overuse of antibiotics is inaccurate estimation of~     pneumonia risk among patients with acute cough illnesses. This study will use a cluster~     randomized trial design within the Geisinger Health System's integrated clinic network to~     measure the efficacy of an algorithm driven clinical decision support tool to safely reduce~     the frequency of unnecessary antibiotic prescriptions for adult patients with lower~     respiratory tract infections.~   "
197211|NCT00981981|"~     The purposes of this study were:~        1. To determine if a breakfast cereal containing 3g of high molecular weight oat~          beta-glucan fiber would lower low-density lipoprotein (LDL) - cholesterol (the bad~          cholesterol) compared to a control cereal containing wheat fiber.~        2. To determine if the LDL-cholesterol-lowering effect of oat beta-glucan fiber was reduced~          when the molecular weight of the fiber was reduced.~   "
197212|NCT00981968|"~     The purpose of this study is to investigate safety, tolerability and pharmacokinetics of~     sitaxentan following single and multiple oral administrations of sitaxentan sodium in~     Japanese healthy subjects.~   "
197213|NCT00981955|"~     Although the beneficial effects of caffeine on cognition and mood have been reported in a~     number of studies, relatively few studies have looked at the effects of caffeine in~     combination with other phytonutrients despite the fact that caffeine is seldom consumed in~     isolation. L-theanine is a naturally occurring amino-acid found in tea, and has been used~     historically as a relaxing agent (Haskell et al., 2008). Few have assessed the impact of~     l-theanine on cognition, but of those that have, the most interesting results were obtained~     when l-theanine was assessed in combination with caffeine (Haskell et al., 2008). It remains~     unclear what is underlying the reported effects.~      Near Infrared Spectroscopy (NIRS) is an emerging neuroimaging technology that is capable of~     determining changes in cerebral blood flow (CBF) by measuring the optical properties of~     oxygenated and deoxygenated blood (Bunce et al., 2006). No study to date has used NIRS to~     assess cerebral blood flow following treatment with either caffeine, l-theanine or a~     combination of both. It is anticipated that the proposed study will provide some insight into~     the mechanism of the previously observed effects both alone and in combination.~      A randomised, double-blind, placebo controlled, balanced crossover design study will assess~     the effects of 75mg caffeine, 50mg l-theanine and a 75mg caffeine/50mg l-theanine combination~     in 24 young healthy adults (18-35). Cognitive and mood assessments will take place at~     baseline and at 30 minutes following treatment whilst cerebral haemodynamics are measured via~     the technique of NIRS.~   "
197214|NCT00981942|"~     The investigators will study the effect of imatinib mesylate (Glivec) in treatment of~     moderate to severe nephrogenic systemic fibrosis (NSF).~      So far there is no evidence of adequately effective treatment options of NSF. Various~     treatments have been tried to stop the progressing disease. Corticosteroids, which suppress~     the early inflammatory stage of the disease, fail to halt disease progression.~      Other immunosuppressive agents, photopheresis, and kidney transplantations are reported to be~     partly beneficial to the patients.~      It has not been possible to confirm these findings in further studies because in~     photopheresis, and kidney transplantation, such effects are generally unreproducible.~   "
197226|NCT00981786|"~     The proposed crossover study will compare for the first time the quality of 24-hour~     intraocular pressure control with the combination of travoprost and brinzolamide/timolol~     compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently~     controlled with travoprost. This comparison may determine the real efficacy of the two fixed~     combinations when added to the prostaglandin. The design of the proposed study should~     facilitate a better understanding of the role of these medications in glaucoma management.~   "
197215|NCT00981929|"~     The Cytochrome P450 enzymes are responsible for the metabolism of a wide range of drugs and~     other xenobiotics. Genetic variants of the encoding P450 genes have shown to influence the~     rate of metabolism of many clinically used drugs.~      The drugs tramadol, omeprazole, losartan, quinidine and caffeine reflect the activity of~     CYP2D6 (tramadol), CYP2C19 (omeprazole), CYP2C9 (losartan), CYP1A2 (caffeine) and CYP3A4/5~     (quinidine).~      The aim of the study is to investigate if the cocktail of tramadol, omeprazole, losartan and~     caffeine can be used to simultaneously determine the activity of CYP2D6, CYP2C19, CYP2C9 and~     CYP1A2. Furthermore, will the natural occurring 4-beta-hydroxy-cholesterol in the blood be~     measured as a metric for CYP3A4/5.~      The study is divided in two. First part will include 12 healthy volunteers and consists of~     three arms separated by at least one week. In the first arm 50 mg of tramadol will be~     ingested and urine will be collected for 8 hours. In the second arm 20 mg omeprazole, 25 mg~     losartan and 200 mg caffeine will be ingested followed by 8 hours urine collection and a~     blood sample 4 hours after administration of the drugs. In the last arm 50 mg of tramadol, 20~     mg omeprazole, 25 mg losartan and 200 mg caffeine will be ingested followed by 8 hours urine~     collection and a blood sample 4 hours after administration of the drugs.~      Metabolic ratios will be calculated based on urine and plasma concentrations of the drugs and~     the relevant metabolites. Relevant genetic variants of the cytochrome P450 encoding genes~     will be determined.~      If the metabolic ratios of the drugs are not significantly different between the arms, Second~     part of the study will be conducted.~      This part is identical with the last arm and will include a maximum of 400 healthy~     volunteers: 50 mg of tramadol, 20 mg omeprazole, 25 mg losartan and 200 mg caffeine will be~     ingested followed by 8 hours urine collection and a blood sample 4 hours after administration~     of the drugs.~   "
197216|NCT00981916|"~     The introduction of local anesthetics and other medications into the epidural space is a~     principal technique in provision of anesthesia in many procedures. Typically the anesthetist~     accesses the epidural space blindly using palpation and visualization of external landmarks~     and then uses a needle to get to the epidural space. The investigators propose a prospective~     study of use of ultrasound in a large heterogeneous group of surgical candidates to define~     the relationship between the actual needle depth (ND) to the epidural space and measured~     ultrasound depth (UD). Establishing correctly the depth to the epidural space via ultrasound~     is a component of ultrasound imaging that might improve current technique, and might lead to~     faster performance of the epidural. Use of ultrasound may also improve the efficacy and~     safety of epidural placement.~      The null hypothesis of this study is that ultrasound depth is similar to the needle depth in~     adult non parturient patients undergoing lumbar and thoracic epidurals. A parturient in this~     case is defined as a female currently near or going through labor.~   "
197217|NCT00981903|"~     In this study the investigators will determine the safety and effectiveness of Tinzaparin in~     preventing blood clots for up to 12 months of treatment.~   "
197218|NCT00981890|"~     The purpose of this study is to determine the maximum dose of sunitinib that can be tolerated~     when treatment is combined with radiotherapy. Patients who decide to take part in the study~     will start taking sunitinib alone for 7 days. On the seventh day of taking sunitinib,~     patients will be given stereotactic radiosurgery (SRS).~      The dose of radiation that patients will receive when they are given SRS is a standard dose~     used to help shrink brain metastases. The dose of radiation and the way it is delivered is~     not experimental.~      Patients will then continue to take sunitinib seven days per week after SRS, and depending on~     how far along the study is when they join, they may continue taking the drug for up to 13~     weeks after SRS. Patients will undergo weekly assessment during study treatment.~   "
197219|NCT00981877|"~     The purpose of this study is to determine the effect of probiotics in rotavirus acute~     diarrhea in children. The investigators will compare the effect of two different probiotics~     products.~   "
197220|NCT00981864|"~     The primary aim of this study is to evaluate the feasibility of delivering 42.5 Gy to the~     breast with a concomitant 10 Gy boost to the tumour bed in 16 fractions for a total duration~     of 3.5 weeks using intensity modulated radiotherapy (IMRT). The primary end-point is the~     proportion of patients treated without major treatment deviation.~   "
197221|NCT00981851|"~     The final purpose of this study is to determine whether bronchodilation and cigarette smoking~     in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase~     of cardiovascular disease. The aim of this part of the study is to demonstrate the basic~     mechanism: Does increased respiratory function after administration of a bronchodilator in~     patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled~     cigarette smoke and to short-term biological effects associated with cardiovascular disease?~   "
197222|NCT00981838|"~     Background. Patients, especially children, with steroid-dependent or multirelapsing nephrotic~     syndrome (NS) secondary to minimal change disease (MCD) or idiopathic focal and segmental~     glomerulosclerosis (FSGS) on continuous treatment with steroids and/or other~     immunosuppressive agents to limit or prevent recurrences are at increased risk of severe~     drug-related adverse events. Case reports suggest that Rituximab, a B cell depleting~     monoclonal antibody, could be a safe and effective alternative to steroid or~     immunosuppressants to achieve and maintain remission in this population.~      Objectives. The study is primarily aimed at evaluating whether Rituximab may maintain stable~     NS remission after tapering and withdrawal of steroid and immunosuppressive therapy in~     patients with MCD or FSGS and steroid-dependent or multirelapsing NS. Secondarily, the study~     will assess whether Rituximab allows reducing maintenance doses of steroids and other~     immunosuppressants (in those who relapse), thus limiting treatment related side effects and~     costs.~      Methods. This prospective, sequential, open, study will include 20 patients with histology~     evidence of MCD or FSGS and steroid-dependant or multirelapsing NS, who are on stable~     complete or partial remission since at least 1 month and, based on their previous history,~     are expected to invariably relapse after steroid/immunosuppression withdrawal. After baseline~     evaluation of clinical, laboratory and kidney function parameters [including glomerular~     filtration rate (GFR), renal plasma flow (RPF), albumin and sodium fractional clearance and~     the glomerular albumin permeability assay (Palb)], patients will receive one Rituximab~     infusion that will be repeated 1 week later if CD20 cells are not fully depleted from the~     circulation. Then ongoing immunosuppression will be progressively tapered up to complete~     withdrawal over 6 to 9 months. 24h proteinuria will be monitored monthly and spot urine will~     be tested daily by albustix to early detect disease relapses. Baseline evaluations will be~     repeated at study end (1 year). Relapses will be treated with high-dose steroids as per~     center practice and the last immunosuppressive therapy effective in preventing disease~     reactivation will be reintroduced.~      Expected results. Rituximab is expected to prevent NS recurrence following tapering and~     discontinuation of steroid and other immunosuppressants. Maintaining remission without~     chronic immunosuppression is expected to minimize risks and costs of therapy and to~     remarkably improve patient outcomes.~   "
197223|NCT00981825|"~     Research study to compare the effects of brushing with two commercially available toothpastes~     on salivary bacteria after brushing~   "
197224|NCT00981812|"~     The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy~     Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on~     suspicious lesions. This study will also allow the doctors to describe the features of PEM~     detected lesions and the results obtained using the PEM guided biopsy and will compare the~     time it took to complete a pre-operative work up using PEM versus MRI in patients with a~     suspicious breast lesion resulting in cancer.~   "
197225|NCT00981799|"~     Nelarabine has shown significant activity in patients with T-cell malignancies. This study~     will determine the safety and maximum tolerated dose of the combination of nelarabine,~     cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first~     relapse of T-LL.~   "
197874|NCT00973011|"~     The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation~     study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal~     (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).~   "
197227|NCT00981773|"~     The aim of the study is to determine whether switching from an antiretroviral regimen~     containing abacavir and/or didanosine to one containing maraviroc will lead to a reduction in~     platelet reactivity and inflammatory markers at weeks 12 and 24 thereby conferring a~     reduction in cardiac risk.~      In addition the study will assess the efficacy of a maraviroc containing regimen in~     combination with a boosted protease inhibitor in terms of tolerability and achieving long~     term viral suppression as assessed at week 48.~      The investigators hypothesize that there will be a rapid reduction in platelet reactivity on~     switching to maraviroc and that a boosted protease inhibitor in combination with maraviroc~     will provide a safe and efficacious antiretroviral regimen enabling a reduction in cardiac~     risk whilst maintaining virological suppression.~   "
197228|NCT00981747|"~     The purpose of this study is to determine whether combination therapy with sildenafil and~     losartan can improve function and exercise tolerance in patients with idiopathic pulmonary~     fibrosis.~   "
197229|NCT00981734|"~     This is an experimental research study. The subjects were randomized into two groups:~     Experimental group (EG; n=58, age: 67 ± 6 old) and Control group (CG; n=40; age: 70 ± 6 old).~     All were physically active without strictly obeying in regularity of the program of physical~     activity.~      The functional autonomy was evaluated by the amount of tests of Group Development of Latin~     American Maturity (GDLAM). It consists of hiking ten meters (C10m); standing up from the~     sitting position (SSP); to stand up from the ventral decubitus position (SSPVD); to stand up~     from a chair and be able to walk around your home (SCWH); and to be able to wear and remove a~     t-shirt (DTS). These tests have showed similar results in indice of GDLAM (IG). The~     intervention took place three times a week, with intensity that has varied between fifty five~     to seventy five per cent of the frequency maximum from heart.~   "
197230|NCT00981721|"~     This study is being carried out to see how single and multiple doses of cediranib are handled~     by the body (that is how they are absorbed, broken down and got rid of from the body) by~     measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.~      The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and~     how the tumour responds to treatment with cediranib.~   "
197231|NCT00981708|"~     The purpose of this study is to determine the safety and activity of the combination of~     lenalidomide with intermediate dose dexamethasone and cyclophosphamide in patients with~     primary systemic (AL ) amyloidosis.~   "
197232|NCT00981695|"~     Objectives:~      Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants~     born to HIV-1-infected mothers.~      Secondary:~        -  HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control~          arms in each cohort (breastfeeding or formula feeding)~        -  HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants~          receiving MVA.HIVA~        -  HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the~          age-matched unvaccinated control group~        -  Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI)~          vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated~          controls in each cohort, between breast versus formula feeding infants in the~          age-matched unvaccinated control group, and between breast versus formula infants~          receiving MVA.HIVA~        -  Comparison of immune activation and phenotypic profile of lymphocytes between breast and~          formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control)~        -  Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.~   "
197233|NCT00981682|"~     The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic~     patients.~   "
197234|NCT00981669|"~     The purpose of this study is to describe the safety, tolerability and immunogenicity of the~     pentavalent rotavirus vaccine produced by Butantan Institute.~   "
197235|NCT00981656|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as~     cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving radiation~     therapy together with cisplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well radiation therapy given together with~     chemotherapy works in treating patients with stage I bladder cancer.~   "
197236|NCT00981643|"~     This study will evaluate the effects of mindfulness and concentration meditation on pain,~     fatigue, and physical functioning in patients with either multiple sclerosis or peripheral~     neuropathy.~   "
197237|NCT00981630|"~     The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new~     formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with placebo.~      Primary Objectives:~      Safety:~        -  To obtain safety and tolerability data for a single subcutaneous vaccination with~          ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old).~      Immunogenicity:~        -  To obtain data on the antibody response to a single subcutaneous vaccination with~          ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior Japanese~          encephalitis immunity.~        -  To assess the durability of immune response up to 12 months following a single~          subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.~   "
197238|NCT00981617|"~     This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo~     in adults with alcohol dependence. There will be 11 study visits conducted over a period of~     about 4 months. The study period includes a screening visit, a 12-week treatment period, and~     a follow-up visit.~   "
197239|NCT00981604|"~     Prospective randomized trial of single incision versus standard 4 port laparoscopic~     cholecystectomy. Hypothesis is that the operative time will be longer with single incision.~   "
197240|NCT00981591|"~     The purpose of this study is to determine whether inhaled iloprost is safe and effective in~     pediatric patients with pulmonary hypertension who are sick in the intensive care unit.~   "
197241|NCT00981578|"~     A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone~     System in the treatment of pain resulting from metastatic bone tumors.~   "
197242|NCT00981565|"~     Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is~     based on symptoms, clinical findings and electrophysiological examination. Several~     conservative and surgical treatment options have been described.~      Studies of surgical versus conservative treatment in mild carpal tunnel syndrome have not~     been done and it is still unclear whether or not surgical treatment is better than~     conservative treatment.~      The aim of this study is to research has surgery better outcome in mild CTS than conservative~     treatment. Patient satisfactory, clinical and electrophysiologic outcomes, direct and~     indirect costs will be evaluated.~   "
197243|NCT00981552|"~     A theoretical planning study to compare the normal tissue irradiation when using intensity~     modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive~     treatment of cervical cancer.~   "
197244|NCT00981539|"~     Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the~     night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped~     uterus). The belief is that there is then less or no stool present at the vaginal incision~     and less chance of infection of the wound by bowel bacteria. However, not all surgeons follow~     this practice. There is no evidence in the medical literature if one way is better than the~     other. In this study, patients scheduled for vaginal surgery to correct prolapse will be~     randomly assigned to perform an enema or not to perform an enema.~   "
197245|NCT00981526|"~     This is a 12-week, randomized, double-blinded, placebo-controlled trial of telmisartan 80~     mg/day as an adjunctive to clozapine or olanzapine therapy, in 70 schizophrenia subjects to~     examine telmisartan's effect on glucose metabolism, weight, food intake, resting energy~     expenditure, and body composition. In addition, the study will examine insulin's effects on~     psychopathology and cognition.~      Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or~     Massachusetts General Hospital. Approximately 70 subjects will be enrolled.~   "
197246|NCT00981513|"~     The purpose of this study is to determine the degree of indirect benefits to family members~     and classmates resulting from administration of influenza vaccine to children.~   "
197247|NCT00981500|"~     The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y~     gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the~     clinical trial. If your insurance does not cover the procedure, then you are responsible for~     payment of the surgical process. We are doing pre and post surgery testing to provide a~     better understanding of the effect of bariatric surgery-induced weight loss on metabolic~     function.~   "
197248|NCT00981487|"~     This study is to assess the effect of food on a single dose of Ondansetron when taken with a~     meal on an empty stomach.~   "
197249|NCT00981474|"~     Neurological complications from cardiac surgery are an important source of operative~     mortality, prolonged hospitalization, health care expenditure, and impaired quality of life.~     New strategies of care are needed to avoid rising complications for the growing number of~     aged patients undergoing cardiac surgery. This study will evaluate novel methods for reducing~     brain injury during surgery from inadequate brain blood flow using techniques that could be~     widely employed.~   "
197250|NCT00981461|"~     The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam~     model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment~     is applied as directed.~   "
197251|NCT00981448|"~     The purpose of this study is to evaluate the effect of zinc supplementation on insulin~     secretion by genotype of SLC30A8.~   "
197252|NCT00981435|"~     The purpose of this study is to determine whether the choice of post-operative eye drop~     administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in~     lowering intraocular pressure (IOP).~   "
197253|NCT00981422|"~     The aim of this study was to evaluate the lymphocyte phenotype in primary open- angle~     glaucoma (POAG) patients compared to healthy subjects of the same age, in order to confirm~     the importance of immune responses in glaucoma and the possible correlation to the severity~     of the disease.~   "
197254|NCT00981409|"~     The primary objective is to evaluate the efficacy (as measured by the rate of recurrent~     symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and Deep Vein~     Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects with acute PE~     in an open-label design.~   "
197255|NCT00981396|"~     The National Health Service (NHS) stop smoking service at the Central Lancashire NHS Trust~     serves a diverse population of smokers, with a very good quit rate and high standards.~     However, clinical experience predicts that some clients are unlikely to succeed through the~     NHS smoking cessation program. This special population has difficulty quitting for a variety~     of reasons. Some relapse over the course of the following two years and return repeatedly to~     the service. Others, for instance those with health problems, may be highly motivated to~     quit, but unable to resist their cravings. The purpose of this study is to determine if EFT~     makes a difference in quit rates with the most challenging population of clients.~   "
197265|NCT00981266|"~     The purpose of this study is to demonstrate safety and effectiveness of Mentor's~     Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision~     breast augmentation. Safety information on the rate of complications, such as infection, will~     be collected and used to help determine device safety. These implants are investigational~     devices.~      Approximately 450 patients at sites across the United States will be enrolled in this~     research study by up to 30 sites. These patients will be implanted with Spectra/Becker 80~     implant and monitored for 10 years to collect information on risks associated with the~     implant surgery as well as changes in the way these patients feel about themselves.~   "
197266|NCT00981253|"~     The purpose of this study is to assess the extent to which combining exercise and stress~     management training (SMT) is more effective at improving biomarkers in vulnerable cardiac~     patients compared to exercise-based cardiac rehabilitation alone.~   "
197283|NCT00981019|"~     The probably most commonly used measure for expressing the pay-offs of early detection and~     treatment are survival rates. Yet, over time and groups this metric comes with several biases~     and thus, is not reliable for judging such benefits. Epidemiologists recommend using~     reduction of disease-specific mortality rates instead, which is unbiased. The purpose of the~     study is to investigate how primary care physicians understand and use different survival~     measures for determining the benefit of cancer screening tests.~   "
197256|NCT00981383|"~     Depressive disorders are common in patients with Coronary Artery Disease (CAD), occurring in~     up to 47% of patients. Left untreated, these symptoms not only have a strong negative impact~     on quality-of-life, but also increase risk of future cardiac events and death. Unfortunately,~     about 64% of CAD patients do not respond to current antidepressant treatments.~     Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are two omega-3 (ω-3) fatty acids~     found in fatty fish that are important for brain function. Recent evidence showed that~     depressed CAD patients have lower levels of EPA and DHA than non-depressed CAD patients. This~     information, taken together with the known roles of ω-3 fatty acids in brain function,~     suggests that deficiencies may contribute to depression. However, it is unknown if increasing~     consumption of ω-3 fatty acids would alleviate depression and improve quality of life. While~     intake of adequate levels of ω-3 fatty acids is difficult to obtain through diet,~     concentrated supplements containing EPA and DHA that are safe, readily available, and~     inexpensive are now obtainable in Canada. CAROTID (CAD Randomized Omega-3 Trial In~     Depression) will randomize patients with CAD, with and without depressive symptoms, after 6~     months of cardiac rehabilitation and usual care to receive either ω-3 fatty acid supplements~     or placebo daily during their final 6 months of cardiac rehabilitation. The investigators~     hypothesize that CAD patients randomized to receive ω-3 fatty acid supplements will show~     greater improvement in depressive symptoms and quality-of-life over time. The investigators~     will also evaluate possible improvements in other important determinants of quality of life:~     memory and other cognitive abilities.~   "
197257|NCT00981370|"~     Hypothesis:~      The investigators suspect that significant degrees of iron overload in subjects with SCD~     result in decreased red cell survival, abnormal endothelial function and markedly~     dysregulated autonomic function. Furthermore, the investigators anticipate that the magnitude~     of these effects is proportional not only to the magnitude of total body iron stores but also~     to the duration of exposure to the high iron levels in tissues.~      Primary objective To determine if red cell survival as assessed by 51Cr red cell survival~     analysis, hemoglobin level, reticulocyte count, lactic acid dehydrogenase, and plasma~     hemoglobin in sickle cell patients is related to the degree of iron overload.~      Secondary objective(s)~        1. Determine if the magnitude of endothelial-dependant vasodilation is related to The~          degree of iron overload.~        2. Determine if the degree of change in cardiac beat to beat variability in response to~          hypoxic exposure or to cold exposure (cold-face-test) is related the magnitude of iron~          overload.~      The primary measure of iron overload will be MRI determination of liver iron concentration.~   "
197258|NCT00981357|"~     Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain~     and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme~     in animals and healthy human volunteers. The purpose of this study is to evaluate whether~     PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and~     whether this results in these patients experiencing less pain.~   "
197259|NCT00981344|"~     The project will examine how mobility performance in real life tasks and environments is~     impacted by the use of specific types of wheeled mobility devices (wheeled walker, manual~     wheelchair, power wheelchair/scooter). Specifically, the project will: 1) randomly recruit~     persons who were prescribed a mobility aid within the preceding 1 year and currently use the~     mobility aid, 2) define key mobility tasks within a public environment, 3) measure mobility~     performance of subjects as they perform the mobility tasks in each of the four devices, and~     4) synthesize and disseminate the results. Study results will be used to establish baseline~     performance data for researchers and clinicians and to identify design improvements for~     wheelchairs used by community dwelling elders.~      All study participants will be required to complete study related questionnaires about their~     family environment and familiarity with the various types of mobility aids. In addition,~     physical abilities will be measured at the start of the study, including measures of arm and~     leg strength, and the ability to walk and push a wheelchair. This will take about 30 minutes.~     A total of 150 subjects will be recruited among Veterans prescribed mobility aids in the~     preceding 3-12 months identified through administrative data sources.~      The mobility aids being studied are all standard types of mobility aids used by people with~     limited mobility (e.g., wheeled walker, manual wheelchair, power wheelchair/scooter).~     Analyses will proceed in a stepwise fashion. The first step will be to examine the primary~     study question relating device type to the dependent variable, with velocity being the~     primary outcome. The next step in the analysis will be to determine if there is an~     interaction between medical condition, mobility devices, and the dependent variable. Finally,~     exploratory analyses will be carried out to examine the relationship between baseline~     measures of physical function and mobility performance with each of the devices. Study~     related risks are minimal.~   "
197260|NCT00981331|"~     The purpose of the study is to determine whether manipulation of the subtalar joint (one of~     the two joints of the ankle) has an effect on ankle range of motion in a group of ankles that~     have sustained a subacute inversion ankle sprain.~      The investigators expect subtalar joint manipulation will increase ankle range of motion~     about the subtalar joint, but not at the talocrural joint (the other joint of the ankle).~   "
197261|NCT00981318|"~     This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no~     nucleoside medications) in HIV patients failing their initial antiviral therapy.~   "
197262|NCT00981305|"~     The purpose of this study is to determine whether lactate-containing vaginal lubricant is~     effective in the treatment of young breast cancer survivors with sexual dysfunction.~   "
197263|NCT00981292|"~     Epigallocatechin gallate (EGCG) is the most abundant catechin (sometimes referred to as tea~     flavonoids) in green tea extract. A review by Nagle et al (2006) identifies that a large~     amount of research indicates EGCG (amongst other catechins) is responsible for most of the~     potential health benefits associated with green tea. EGCG is brain permeable (Nakagawa &~     Miyazawa, 1997), and it is considered to have neuroprotective and neurorescue effects~     including modulation of cell survival and cell cycle genes (Levites et al 2002).~      Although there have been several human studies looking at the bioavailability of EGCG when~     administered in varying doses, there have been no studies that have specifically investigated~     the cognitive effects of this catechin in humans. Therefore, the purpose of this study is to~     assess the cerebral blood flow (using Near Infrared Spectroscopy), cerebro-electrical~     activity (EEG) and behavioural effects of EGCG. A randomised, double-blind,~     placebo-controlled, balanced crossover study will assess the effects of 135 mg and 270 mg~     pure EGCG in 24 healthy, young adults (18-35). Prior to the first active study day~     participants will attend a screening/training visit where relevant exclusion criteria will be~     assessed including any food sensitivities. They will also complete a caffeine consumption~     questionnaire in order to control for potential caffeine withdrawal effects as a result of~     restrictions of the study.~   "
197264|NCT00981279|"~     The aim of this study was to delineate the epidemiological profile of HIV seropositive~     patients on antiretroviral therapy at the Clinical Hospital of the Federal University of~     Goiás.~   "
197267|NCT00981240|"~     Primary objectives:~        -  To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose~          limiting toxicities (DLTs) in the proposed dose regimen~        -  To evaluate the pharmacokinetic (PK) profile of SAR103168~      Secondary objectives:~        -  To characterize the global safety profile of SAR103168~        -  To evaluate preliminary anti-leukemia activity~        -  To investigate the potential induction effect on CYP3A4 and persistence of this effect~          by using oral midazolam as a probe substrate in patients enrolled into the expanded~          cohort at the MTD~        -  To determine the metabolic pathways of SAR103168 and identify the chemical structures of~          metabolites~        -  To determine the potential impact of SAR103168 on the QTc interval in patients enrolled~          at the MTD~   "
197268|NCT00981227|"~     The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL)~     as therapy for patients with post-herpetic neuralgia.~   "
197269|NCT00981214|"~     This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand)~     pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic~     fibrosis (CF) and exocrine pancreatic insufficiency (EPI).~   "
197270|NCT00981201|"~     The purpose of this study is:~        -  To examine the effect of celecoxib treatment on Ki-67 expression, a marker of cell~          proliferation, in the bronchial epithelium of current and former smokers.~        -  To examine the toxicity associated with celecoxib administration.~        -  To measure the effect of celecoxib treatment on arachidonic acid metabolites in the~          bronchial epithelium of current and former smokers.~   "
197271|NCT00981175|"~     The purpose of this study is to assess the safety, tolerability, immunogenicity, and duration~     of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in~     adults.~      Objectives:~      Safety:~        -  Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE compared~          with a placebo in adult volunteers (≥ 18 to <55 years) without prior Japanese~          encephalitis (JE) vaccination.~      Immunogenicity:~        -  Obtain data on the antibody response in adult volunteers following administration of~          ChimeriVax™-JE~        -  Assess the durability of the immune response in adult volunteers over 60 months~          following one or two doses of ChimeriVax™-JE.~   "
197272|NCT00981162|"~     This phase I/II trial is studying the side effects and best dose of everolimus when given~     together with sorafenib tosylate and to see how well they work in treating patients with~     advanced solid tumors and metastatic pancreatic cancer that does not respond to gemcitabine~     hydrochloride. Sorafenib tosylate and everolimus may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the~     growth of pancreatic cancer by blocking blood flow to the tumor. Giving sorafenib tosylate~     together with everolimus may kill more tumor cells.~   "
197273|NCT00981149|"~     Temporomandibular joint disorders (TMJD) are a family of musculoskeletal disorders that~     represent the most common chronic orofacial pain condition. TMJD is associated with~     persistent pain in the region of the temporomandibular joint and muscles of the head and~     neck. The purpose of this study is to test duloxetine (Cymbalta) as a potential treatment for~     chronic facial pain. Duloxetine is FDA approved as an antidepressant and for the chronic pain~     conditions of fibromyalgia and diabetic neuropathy. Chronic facial pain may be linked to~     Temporomandibular Joint Disorder (TMJD) which currently has no standard treatment.~   "
197274|NCT00981136|"~     This is a prospective trial of single incision versus standard 3-port laparoscopic~     appendectomy.~      The hypothesis is that there may a difference in wound infection rates, operative time, doses~     of analgesics post-operatively, and patient/parent perception of scars.~   "
197275|NCT00981123|"~     Observational, non-comparative, epidemiological study to collect and analyse real life data~     on schizophrenic patients receiving quetiapine according to the standard medical practice in~     Croatia. The main objectives are to assess after 6 months of quetiapine therapy severity of~     illness and global improvement in patients using Clinical Global Impression (CGI) scale.~   "
197276|NCT00981110|"~     The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing~     in comparison with the efficacy of standard dressing in terms of prevalence of surgical site~     infections (SSI) in patients who underwent colorectal resection for malignancy.~   "
197277|NCT00981097|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research study is looking at blood and tissue samples from patients with~     aggressive non-Hodgkin B-cell lymphoma or Hodgkin lymphoma.~   "
197278|NCT00981084|"~     The investigation will involve a double-blind, placebo controlled, cross-over study examining~     the efficacy of armodafinil in improving neurocognitive functioning and reducing cognitive~     fatigue in MS. Patients who report MS-related cognitive difficulties and perform at least 1~     standard deviation below the mean on a brief cognitive screen will be given a thorough~     neuropsychological evaluation at two time points. Half of the patients will be randomized to~     receive a single oral dose of lactose placebo prior to the first testing session. After a~     washout period of one week, they will then receive 250mg of armodafinil prior to a second~     testing session (P/A group). The other half of patients will be randomized to receive the~     active drug first. After a washout period of one week, they will receive the placebo prior to~     a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours~     after administration, participants will be asked to take a single 250mg capsule 2 hours prior~     to the scheduled testing sessions.~   "
197279|NCT00981071|"~     The aim is to evaluate the time of positive conversion after exposure to smear positive~     pulmonary tuberculosis (TB) in a platoon of Korean military, a closed communal setting.~   "
197280|NCT00981058|"~     The research study is testing the investigational drug necitumumab (IMC-11F8) in the~     treatment of advanced non-small cell lung cancer. The aim of this study is to determine if~     necitumumab, given together with a standard chemotherapy combination consisting of cisplatin~     and gemcitabine will be more effective in improving participant disease than the standard~     chemotherapy combination alone.~   "
197281|NCT00981045|"~     The primary objective of this study is to examine the efficacy and safety (cardiovascular) of~     an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron~     sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal~     function.~   "
197284|NCT00981006|"~     The aim of this study is to evaluate the safety and efficacy on the transplantation of~     autologous human cardiac-derived stem cells (hCSCs) with the controlled release of basic~     fibroblast growth factor (bFGF) to severe refractory heart failure patients with chronic~     ischemic cardiomyopathy concordance with reduced left ventricular dysfunction (15%≦LVEF≦35%).~   "
197285|NCT00980993|"~     Patient anatomy and position during the course of radiation therapy can vary from those used~     for treatment planning; a function of patient movement, uncertainty in positioning system,~     and organ motion. Traditionally, treatment margins are designed to compensate for~     interfraction prostate setup variability. This approach has the potential to lower the~     overall effectiveness of treatment because the prostate gland is a continuously moving target~     whose motion cannot be accurately accounted for solely on the basis of interfraction~     movement. More recently, the dosimetric relevance of intra-fraction prostate motion has been~     recognized, and may be compensated for by continuous real-time adaptive radiation therapy~     afforded by the Calypso 4D Localization System™. In the current study, the investigators~     propose to characterize intrafraction prostate motion. The investigators hypothesize that~     intrafraction prostate motion is correlated with respiratory motion.~   "
197286|NCT00980980|"~     The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA~     (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three~     strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care~     units. The three strategies to be evaluated are:~        -  screening on admission followed by isolation of MRSA+ patients~        -  screening on admission followed by isolation and decolonization of MRSA+ patients~        -  universal decolonization on admission with no screening. The decolonization regimen~          involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main~          outcome will be MRSA+ clinical cultures.~      The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital~     Corporation of America.~   "
197287|NCT00980967|"~     Obliterative Bronchiolitis (OB) is the major cause of long-term lung allograft loss for~     patients with end stage pulmonary diseases like cystic fibrosis. Numerous cells and proteins~     are implicated in this process, which have never been studied prospectively in a multicentric~     longitudinal cohort. The aim of this study is to detect predictive risk factors of OB through~     a national multicentric cohort of 500 newly transplanted recipients (COLT). COLT will consist~     in a large database, associated with a recipient bio-collection, and specific projects using~     these resources. COLT will aggregate all the 11 French centres of pulmonary transplantation.~     Patient will be followed-up during 5 years. Blood samples will be obtained. Induced sputum,~     bronchoalveolar lavage fuid, exhaled breath condensate and trans bronchial biopsies will be~     also taken. T cells, known to be involved in chronic rejection will be studied, and genomic,~     microarray and proteomic approaches will be used to detect further predictive factors. A~     study on Circulating Endothelial Cells and Circulating Endothelial Progenitors is also~     realised from blood samples. COLT will prove molecular markers to be predictive of early OB,~     before the development of severe airway obstruction and will allow the identification of~     patients at high risk of OB. COLT will identify potential targets for future treatments of~     OB. This collaborative project makes research and clinical teams working together, and~     creates the conditions of a long term network, extendable to other laboratories with new~     projects and additional European transplant centres.~   "
197288|NCT00980954|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     It is not yet known whether chemotherapy and radiation therapy are more effective when given~     with or without additional chemotherapy in treating cervical cancer.~      PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation~     therapy to see how well they work when given with or without additional chemotherapy in~     treating patients with high-risk early-stage cervical cancer after radical hysterectomy.~   "
197289|NCT00980941|"~     The investigators hypothesize that different types of starch vary in their effects on~     appetite, blood sugar and food intake. In this study, subjects consumed five soups containing~     50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added~     starch at one week intervals. The investigators measured food intake at 30 minutes, appetite~     and blood sugar.~   "
197290|NCT00980915|"~     The purpose of the study is to identify the patients at high risk of developing Acute Lung~     Injury (ALI) at the time of hospital admission, and before intensive care unit admission.~      Aim 1- To validate the prediction model (Lung Injury Prediction Score) in a population based~     sample of hospitalized patients.~      Aim 2- To determine the significance of health-care related ALI risk modifiers in a~     population based sample.~      Aim 3- To compare the short and long term outcomes between patients at high risk who do, and~     do not develop ALI.~   "
197291|NCT00980889|"~     Less than 20% of patients with malignant distal bile duct (BD) obstruction (often pancreatic~     cancer) are suitable for resection surgery.In the rest,palliation treatment comes into focus.~     Jaundice caused by BD obstruction gives pain, infection (cholangitis), often itching and~     increased weight loss, and the patient is stigmatized by the deep yellow colour of the~     skin.Therefore palliation with endoscopic stenting by ERCP-technique is important. Modern~     self-expanding metal stents (SEMS) are now widely used in this context. Comparison in a RCT~     between steel and nitinol SEMS has never been performed.~      The steel stent (Wallstent®) is the original,is widely used, and has more expanding power.~     Nitinol stents are softer and claimed to be easier to insert,and are more and more popular.A~     newly developed nitinol stent (Wallflex®)may have these advantages, but is some 120 Euros~     more expensive.~      Regarding the most important outcome measure, time to stent failure (obstruction), no one~     knows if there is any difference.Our hypothesis is that there is no difference in this main~     outcome endpoint.~   "
197292|NCT00980876|"~     The objective of this study is to compare the efficacy and safety profiles of the test~     product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of~     hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.~   "
197349|NCT00979992|"~     This phase II trial studies the side effects of sunitinib malate and how well it works in~     treating patients with ovarian cancer that is persistent or has come back. Sunitinib malate~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and~     by blocking blood flow to the tumor.~   "
197293|NCT00980863|"~     Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases~     the risk for somatic disease and non-adherence to maintenance therapy. Therefore,~     interventions addressing weight gain are expedient for the management of this disorder. The~     investigators set out to evaluate the effects of a lifestyle intervention on body mass index,~     cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under~     mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood~     stabilizing treatment participated in a randomized controlled trial (waiting control group~     N=24 and multimodal lifestyle intervention N=26). Each experimental group consisted of two~     cohorts. The intervention lasted five months and consisted of eleven group sessions and~     weekly fitness training. Body Mass Index (BMI), body weight as well as cardiovascular,~     glycemic and metabolic parameters were determined as baseline (March and September 2005) and~     after five (July 2005 and January 2006) and eleven months (January and July 2006).~   "
197294|NCT00980850|"~     In the first half of this year a novel Influenza A H1N1 virus has resulted in an influenza~     pandemic. The United Kingdom has seen a particularly high incidence of disease. The highest~     rates of disease are being seen in young children. In anticipation of an influenza pandemic~     two vaccine manufacturers, Baxter and GlaxoSmithKline, have gained marketing authorization~     approval from the European Medicines Agency (EMEA) for a pandemic strain vaccine under the~     mockup dossier route based on limited clinical trial data for a candidate H5N1 vaccine.~     This mockup dossier route for pandemic influenza vaccines allows the submission of a core~     pandemic dossier during the interpandemic period, which results in the approval of a mockup~     pandemic vaccine. This is followed by a fast track approval of the pandemic vaccine based on~     the submission of the pandemic variation when the situation arises. The Baxter and~     GlaxoSmithKline vaccines have now been modified to cover the novel influenza A H1N1 strain.~      Given the high rates of swine flu disease in children, this age group is likely to~     particularly benefit from immunization against this virus, however there are few data on the~     use of these vaccines in a pediatric population. The proposed study therefore aims to assess~     the immunogenicity, safety, and tolerability of these two H1N1 vaccines when administered as~     two doses three weeks apart to children aged 6 months to 12 years of age.~   "
197295|NCT00980824|"~     Scotland has higher rates of suicide than other parts of the UK, an average rate of 15.1 per~     100,000 in Scotland compared to 11.4 for England and Wales. The Scottish Government is~     committed to reducing suicide by 2013. Choose Life has led to staff in services such as~     Accident and Emergency (A&E) receiving recent training in suicide prevention through ASIST~     and STORM.~      Evidence for interventions specific to A&E setting is limited despite the fact that this is~     the most likely point of first contact with health services for people at risk of this~     behaviour. Brief interventions that reduce repetition of self harm have not been particularly~     effective partly because of poor attendance and lack of focus on comorbidity. We propose to~     pilot an evaluation of a brief focused intervention, ENGAGE (based on MAnualised Cognitive~     Therapy,MACT, developed by the investigator (Kate Davidson) and Prof Ulrike Schmidt of the~     Institute of Psychiatry, London) for those who present at A&E with a suicide attempt and who~     have a complex presentation - a combination of substance abuse and or personality disorder,~     all of which are recognized as high risk factors for suicide. ENGAGE will specifically~     encourage patients to seek appropriate services to meet their mental health needs. This pilot~     will allow us to assess the feasibility of a full scale study.~   "
197296|NCT00980798|"~     This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a~     once-daily formulation of a strong opioid against placebo in patients, who are suffering from~     pain due to osteoarthritis of the hip or the knee and who previously did not receive any~     strong opioids.The clinical trial tests the effect of the treatment on symptoms of pain,~     stiffness and physical function. The effect of the treatment on parameters on health related~     quality of life as well as quality of sleep will be measured.~   "
197297|NCT00980785|"~     Angiotensin converting enzyme inhibitors (ACE-I) are a group of blood pressure-lowering~     medicines. Some studies suggest that ACE-I, such as ramipril, may help prevent Alzheimer's~     disease (AD). The purpose of the research is to see how ramipril affects a substance in the~     body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the~     brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of~     getting Alzheimer's disease. This study will see if ramipril can lower the amount of~     beta-amyloid in the spinal fluid. This study will also see if ramipril affects blood vessel~     function and memory and thinking. The investigators hope that future studies will show~     whether ramipril might prevent memory loss and decrease the chance of developing Alzheimer's~     disease.~   "
197298|NCT00980759|"~     This study is an open-label, multi-institutional, randomized phase II study, which is~     designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing~     recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival~     of locally advanced uterine cervical cancer. Radiotherapy is given as a conformal technique~     based on the individually taken CT scan and cisplatin is given concomitantly with~     radiotherapy in both EFI arm and pelvis only treatment arm. According to our past study~     result, patients with more hypoxic tumors are more likely to develop distant metastasis~     including the recurrences at PAN (1-3). This study started with examination of CA9 (hypoxia~     marker) expression in the primary cervical tumor before randomization because it was expected~     that there would be a differential benefit of EFI in patients with CA9-positive vs~     CA9-negative tumors. However, the study design was modified because there was too much delay~     in the patient with CA9-negative tumors. The patients are now registered and then immediately~     randomized to experimental (EFI) and control arm (pelvis only treated) with examination of~     CA9 expression at later time.~   "
197299|NCT00980746|"~     The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL)~     as therapy for patients with painful diabetic neuropathy.~   "
197313|NCT00980525|"~     The purpose of this study is to determine if certain levels of proteins lead to inflammation~     of the gums. One example of such proteins being studied is called Interleukin 1 (IL-1). This~     protein is found at higher levels in areas of inflammation. This type of study is called an~     experimental gingivitis study. It will involve stopping your routine oral health care for 21~     days. If you qualify, you will receive a full dental cleaning at the beginning and end of the~     study. Approximately 30 patients will participate in this study at the Michigan Center for~     Oral Health Research (MCOHR).~   "
197300|NCT00980733|"~     To evaluate the efficacy of consumption of yoghurt fortified with 30% recommended dietary~     allowance (RDA) of essential micronutrients (iron, zinc, vitamin A and iodine) for a period~     of one year in comparison to same yoghurt without fortification for change in mean levels and~     proportion deficient for markers of status of Iron (Hemoglobin, Serum ferritin, Serum~     transferrin, ZnPP), Vitamin A (Plasma retinol levels), Iodine (Urinary iodine levels), Zinc~     (Plasma zinc), and copper (Plasma copper levels, sub sample of children); improvement in~     cognitive development, reduction in episodes/days of illnesses (diarrhea, pneumonia, febrile~     illness), hospitalizations and morbidity causing absenteeism from school and improvement in~     growth. Additionally to evaluate the efficacy of consumption of fortified and non fortified~     yoghurt (plain yoghurt) for a period of 12 months in comparison to pure control that do not~     receive any intervention in the improvement in cognitive development and physical growth. The~     main objective is to evaluate the impact of addition of micronutrients to Yoghurt and can be~     best addressed by RCT. The effect of taking yoghurt per se cannot be blinded so for that the~     investigators have included a concurrent control.~      Hypothesis: Consumption of fortified yoghurt with 30% RDA of essential micronutrients (iron,~     zinc, vitamin A and iodine) for a period of one year will improve the micronutrient status~     indicators, cognitive development, and growth and reduce morbidity of children.~   "
197301|NCT00980707|"~     The purpose of this study is to determine the role of versican and hyaluronan measurements in~     induced sputum as biomarkers of asthma. Enroll 10 subjects with mild persistent asthma who~     are not receiving treatment with a controller therapy.~   "
197302|NCT00980694|"~     The death of brain cells in Huntington Disease (HD) is thought to be associated with a lack~     of normal cell energy and harmful brain substances called free radicals. Coenzyme Q10 (CoQ)~     is a marketed nutritional supplement that may prove useful in HD because it increases cell~     energy and combats free radicals.~      Most studies of CoQ have looked at only one formulation of CoQ (ubiquinone) in HD. The~     purpose of the study is to find out if people that switch from the common formulation of CoQ~     (ubiquinone) to a different formulation (ubiquinol) have higher levels of CoQ in their~     blood after taking the same dose. The investigators also want to find out if this different~     formulation is tolerable for individuals with HD.~   "
197303|NCT00980681|"~     The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA~     in patients suffering from renal arterial disease.~   "
197304|NCT00980655|"~     People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more~     likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people~     who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal~     polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study~     is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal~     vaccine (13vPnC) followed by 23vPS.~   "
197305|NCT00980642|"~     Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at~     the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal~     temperature and oral temperature for routine clinical use during hypothermic conditions, as~     well as during fever.~   "
197306|NCT00980629|"~     This study is to investigate the efficacy and safety of M516102 and to evaluate the dose~     response relationship of M516102 and placebo, in the treatment of pruritus associated with~     atopic dermatitis.~   "
197307|NCT00980616|"~     The aim is to determine if the use of infiltration with an adrenalin solution in the~     operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the~     cumulated volume of bleeding (pre and post operative) without increasing the per and post~     operative risks. At the same time, the effect on the post operational pains is evaluated.~   "
197308|NCT00980603|"~     The purpose of this study is to assess efficacy and safety of docetaxel alone, docetaxel plus~     cisplatin, and docetaxel plus S-1 in patients with metastatic gastric cancer after failing~     1st line chemotherapy with cisplatin plus S-1 or capecitabine~   "
197309|NCT00980590|"~     Pre-hospital intubation is often required in sub-optimal conditions, such as in patients~     lying on the ground. Direct laryngoscopy and intubation of a patient lying supine on the~     ground is difficult because the intubator's head is far above the head of the patient. It is~     thus tricky to align the intubator's visual axis with the patient's tracheal axis. The Airway~     Scope is a new laryngoscope designed to facilitate intubation without requiring alignment of~     the oral, pharyngeal, and tracheal axes. We thus tested the hypothesis that the intubation~     with the Airway Scope is faster than the Macintosh laryngoscope in subjects lying on the~     ground.~   "
197310|NCT00980577|"~     To study whether the combination of ultrasound guidance and stimulating catheter could reduce~     the time for needle and catheter insertion compared with using stimulating catheter alone.~     Secondary outcomes: analgesic effects after the surgery.~   "
197311|NCT00980551|"~     The investigators are testing subtenon carboplatin in combination with vincristine and~     topotecan given by vein in the hopes of finding a drug combination that may be effective~     against retinoblastoma that has come back (recurrent) or is resistant to other treatment~     (refractory).~      The goals of this study are:~        -  To decide if the drug combination is a useful treatment for recurrent or refractory~          retinoblastoma~        -  To test the safety of the drug combination and to see what kind of effects (good and~          bad) can be expected from the drug combination~        -  To measure visual changes before and after the study therapy~        -  To use a special MRI scan to measure brain function involved in vision processing, both~          before and after the study therapy~      In this study, the investigators are also testing a new experimental way of giving~     carboplatin subtenon carboplatin. The carboplatin will be given directly in the eye through~     a needle placed under the covering of the eye. This is to try to get more carboplatin to the~     retinoblastoma inside the eye.~   "
197312|NCT00980538|"~     The primary objective is to continue the provision of etravirine (ETR) for patients who~     previously received ETR in a clinical pediatric trial sponsored by or in collaboration with~     Janssen Research & Development, and who continue to benefit from the use of ETR, in countries~     where ETR is not commercially available for pediatric use, is not reimbursed, and cannot be~     accessed through another source (e.g. access program or government program), or where the~     patient is not eligible for ongoing trials/programs with ETR.~   "
197316|NCT00980473|"~     Glaucoma is the leading cause of irreversible blindness worldwide. With ageing of the~     population, glaucoma morbidity will rise, causing increased health care costs and economic~     burden for a condition in which visual loss, once established, cannot be reversed. In~     contrast to western countries, primary angle closure glaucoma (PACG) is a major form of~     glaucoma in Asia. In a recent population based survey in Singapore, the prevalence of~     glaucoma was 3.2% in the Chinese population over 40. Glaucoma was the leading cause of~     blindness, with PACG the most visually destructive form of the disease.~      Laser iridotomy is the current first line treatment for PACG. It acts by relieving pupil~     block, which in turn may reduce intraocular pressure (IOP) and prevent progression of~     glaucoma. However recent data indicate that iridotomy is not successful in controlling IOP in~     the long term, and the majority of cases develop a clinically significant rise in IOP~     requiring medical therapy or surgery.~      Argon laser peripheral iridoplasty (ALPI) offers a new therapeutic option for PACG. The~     procedure consists of placing contraction burns in the iris periphery which results in~     contraction of the iris stroma and opening of the angle.~      The proposed study is a 2-centre randomized controlled trial to determine whether ALPI is an~     effective and safe treatment in the management of PACG. 210 patients with PACG and high IOP~     (>21 mmHg) following laser iridotomy will be randomized to receive ALPI or medical treatment~     to achieve IOP control. Subjects will be followed up for 12 months and the outcome criteria~     will be the rate of medical treatment and surgery in each group, and the angle width and~     configuration.~      This will be the first RCT worldwide to address the role of ALPI in PACG. The study findings~     will have great relevance for the prevention of glaucoma blindness in the elderly.~   "
197317|NCT00980460|"~     This phase III trial studies the side effects and how well risk-based therapy works in~     treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs~     (cancer fighting medicines), and when necessary, liver transplant, are the main current~     treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best~     treatment. Treating patients according to the risk group they are in may help get rid of the~     cancer, keep it from coming back, and decrease the side effects of chemotherapy.~   "
197318|NCT00980447|"~     UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004).~      The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among~     three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per~     patient with a 3 week interval between vaccination in healthy young adults.~      Immunogenicity will be confirmed by both microneutralization (MN) antibody and~     hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving~     different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a~     total of 90 healthy young adults aged 20-40 years enrolled in this study.~   "
197319|NCT00980434|"~     The investigators are studying the clinical worth of the serum markers S-100B and NSE in~     patients with spinal cord injuries e.g. in patients with vertebral fractures. If there is a~     injury to the neuronal structures these two proteins could be secreted into the serum and add~     evidence to the severity of the injury.~   "
197320|NCT00980421|"~     The purpose of study is to evaluate and compare the effect of iron supplementation when given~     as iron tablet or fortified biscuit or combined with zinc in the form of tablet on morbidity~     and iron toxicity markers among children aged 24-36 months.~   "
197321|NCT00980408|"~     The hippocampus is particularly laden with n-methyl-d-aspartate (NMDA) receptors, and is at~     the same time one of the most important sites in declarative memory. The rationale of this~     study is that the NMDA partial agonist D-Cycloserine will promote learning compared to a~     placebo. On the other hand, the NMDA receptor antagonist Memantine might lead to reduced~     memory. We believe that the influence of NMDA receptors on memory can be determined via acute~     co-activation of the NMDA receptors with Cycloserine® (King Pharmaceuticals Ltd, active~     ingredient: DCycloserin, dose: 250 mg) and Memantine (Axura®, Merz, active ingredient:~     Memantine, dose: 20 mg)on both a behavioral and functional (fMRI) level.~   "
197322|NCT00980395|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Giving bortezomib together with~     cladribine and rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with cladribine~     and rituximab works in treating patients with advanced mantle cell lymphoma or indolent~     lymphoma.~   "
197323|NCT00980382|"~     This study is an open-label, single center, nonrandomized study, consisting of a~     dose-escalating phase I study in advanced solid cancer and a subsequent phase II study in~     metastatic gastric cancer. In phase I study, we aim to determine the MTD and the recommended~     dose of S-1 combined with docetaxel given every 3 weeks. Dose level and escalating schedule~     are followings~        -  S-1(level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14)~        -  Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) mixed in d5w 200 ml iv over 60 min:~          Days 1, 8with dexamethasone 8 mg po q 12hr for 3 days (total 6 doses: D0-2)and~          parenteral pheniramine maleate 1 ample (45.5mg) before docetaxel~   "
197324|NCT00980369|"~     The purpose of this study is to determine effective incision type for the treatment of~     chronic anal fissures.~   "
197325|NCT00980356|"~     The purpose of this study is to determine whether monotherapy with Vildagliptin improve~     glycemic control in kidney transplanted patients with newly diagnosed New Onset Diabetes~     after Transplantation (NODAT).~   "
197326|NCT00980343|"~     This randomized phase II trial is studying how well GDC-0449 works in treating patients with~     recurrent glioblastoma multiforme that can be removed by surgery. GDC-0449 may be effective~     in treating patients with glioblastoma multiforme.~   "
197327|NCT00980330|"~     The purpose of this study is to determine the efficacy, safety and tolerability of different~     regimens of TMC435 with standard treatment compared to standard treatment alone in~     participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed~     previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).~   "
197372|NCT00979693|"~     This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are~     safe and will help people who are anxious as a result of having stage IV melanoma and will~     involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin. The study~     will measure anxiety, depression, quality of life and spirituality before and after~     psilocybin-assisted psychotherapy, natural killer cells (a type of immune cell) will be~     counted from blood samples taken the day after psilocybin-assisted psychotherapy, and people~     will keep daily diaries reporting on how anxious they feel for each day in the study.~   "
197328|NCT00980317|"~     Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die~     every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000~     patients are registered to the Japan Organ Transplant Network (JOTN) with the hope for a~     renal transplantation. If the renal function is restored by transplantation, the quality of~     life (QOL) improves and more than 90% are reportedly come back to their normal life~     activities and get relieved from the burden of dialysis. Furthermore, it can reduce the~     dialysis related medical cost by as much as 50%. However, only about 1,000 renal~     transplantation cases are annually carried out in Japan. Among them, 80-85% are living renal~     transplantations offered by family members or relatives, and the rest are from deceased~     donors.~      Due to the fact that the number of deceased donors are scarce and renal transplantations~     between non-relatives (third parties) are currently not allowed in Japan, the approximate~     waiting time to receive a renal transplantation is 16 years. For that reason, many patients~     travel abroad to receive a renal transplantation.~      There are reports that total nephrectomies are performed as a treatment for small size (4 cm~     or less) renal tumors in many cases and that many of these nephrectomized kidneys can be~     successfully transplanted after surgical restoration with satisfactory results. However, due~     to the lack of necessary evidence it is currently not allowed in Japan.~      Therefore, the investigators planned the present clinical study to evaluate the curative~     efficacy (renal function, QOL) and safety (side effects, complications or occurence of renal~     cancer) of living renal transplantations between third parties (non-relatives) with restored~     donor kidneys after the surgical removal of a small size (4 cm or less) renal tumor, in order~     to acquire necessary clinical data for potential enrichment of the renal donor pool in Japan~     as well as to develop useful medical care for our patients who are on dialysis for many years~     due to the renal failure.~   "
197329|NCT00980304|"~     It is a phase II , multicenter, open label clinical trial. Only the relapsed DLBCL patients~     after 1st line induction treatment of 6~8 cycles of RCHOP-like chemo will be enrolled to~     receive 3 cycles of RICE as salvage therapy.~      After treatment each patient should be followed up for 2 years.~   "
197330|NCT00980278|"~     The purpose of this research is to determine if one's own bone marrow tissue can help~     regenerate (grow) bone in the area of the jaw where an implant will be placed. The name of~     the process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be~     collected and sent to a laboratory where it will be processed to form more cells. These new~     cells will then be transplanted in the regenerative site or sinus floor augmentation site.~     The researchers are testing to see if these cells (BRC) will help form bone indicating. The~     research will also determine if the implant will be more stable in the area with new bone~     growth.~   "
197331|NCT00980252|"~     This is a randomized pilot study of an intervention based on principles of Cognitive~     Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and~     will be compared to a traditional medical model of psychoeducation known as Team Solutions~     (TS) for first-episode schizophrenia patients. Outcomes include the acceptance of HDI and TS,~     compare adherence attitudes at the end of the treatment intervention, and to compare the time~     until the first episode of nonadherence.~   "
197332|NCT00980239|"~     The goal of this clinical research study is to learn the highest tolerable dose of irinotecan~     that can be given directly into the liver, in combination with other drugs given by vein.~      The other drug combinations given by vein include bevacizumab alone, bevacizumab plus~     oxaliplatin, and bevacizumab plus cetuximab.~      This will be tested in patients with advanced solid tumors that have spread to the liver. The~     safety of these drug combinations will also be studied.~   "
197333|NCT00980213|"~     Patient receiving sunitinib according the clinician's independent decision as first-line~     treatment of advanced renal cell carcinoma (RCC) will be asked for informed consent.~     Treatment with sunitinib will start and end solely on the treating clinicians and the~     patients independent discretion. Consenting patients will prospectively answer standardized~     quality of life questionnaires (15D, EQ-5D) during the treatment. Data on health care~     resource utilisation will be collected prospectively (outpatient visits, hospital stays,~     concomitant drugs, investigations, sick-leaves, travels). In addition, after treatment~     failure anti-cancer drugs, hospital stays and date of death will be recorded.~      The health economic data during sunitinib treatment and the length of the sunitinib treatment~     will be compared with the corresponding previously published data collected retrospectively~     from patients with the same condition treated with IFN-alfa. Stepwise regression analysis~     will be used to explore whether patient and tumor characteristics explain potential variation~     in treatment duration and costs that is not explained by the treatment.~      Health-related quality of life (HRQoL) data will be presented as descriptive data and~     compared to age-standardized general population.~      At least four major Finnish oncology centers have consented to participate in this study. The~     inclusion time will be approximately 24 months, and the study time approximately 48 months.~     Eighty patients will be included.~   "
197334|NCT00980200|"~     The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate~     the efficacy and safety of selected doses and dose intervals of the novel long acting beta~     agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving~     inhaled corticosteroid treatment.~   "
197335|NCT00980187|"~     The aim of this study is to evaluate the effects of indapamide SR 1.5 mg on blood pressure,~     blood tests (glucose metabolism, lipids, minerals, and uric acid), cardiac function,~     endothelial and arterial function, by comparison with hydrochlorothiazide 25 mg, in patients~     with hypertension and type 2 diabetes mellitus. In order to achieve a better control of blood~     pressure in these patients, each diuretic treatments will be added to an ACE inhibitor~     (quinapril 10-40 mg/day). Therefore, eventually, the study will provide data on the~     comparison between combination indapamide SR 1.5 mg + quinapril versus hydrochlorothiazide 25~     mg + quinapril.~   "
197336|NCT00980174|"~     The purpose of this study is to assess how effective and safe denosumab is in a population of~     males with low bone mass at risk of fracture. The primary clinical hypothesis is that in men~     with low bone mineral density, the mean percent change in lumbar spine bone mineral density~     at 12 months in subjects receiving denosumab will be greater than in subjects receiving~     placebo. Denosumab is a fully human monoclonal antibody with a high affinity for Receptor~     Activator of Nuclear Factor (RANK) Ligand that can bind and neutralize the activity of human~     RANK Ligand similar to the action of endogenous osteoprotegerin.~   "
197373|NCT00979680|"~     This phase III trial included patients with low rectal adenocarcinoma which initially~     required APR, with a mean clinical distance between the tumor inferior pole and the levator~     ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or~     radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the~     tumor status at surgery. All surgeons used a homogenous SSR technique such as~     intersphincteric resection. The primary endpoint was the SSR rate.~   "
197374|NCT00979667|"~     To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with~     its control arm with respect to symptoms duration among patients infected with influenza A~     (H1N1) virus.~   "
197337|NCT00980161|"~     Combination therapy with peginterferon plus ribavirin has become the current standard of care~     for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR)~     rate of 54-63%. Based on the ample evidence, a 48-week course of peginterferon plus~     weight-based ribavirin therapy is widely recommended to treat HCV genotype 1 infection in~     different parts of the world. Despite the increased SVR rates with the improved medical~     therapies, about 25-50% and 10-20% of HCV genotype 1 and HCV genotype 2/3 patients may~     experience relapse after the cessation of therapy with undetectable HCV viremia at the end of~     treatment. Moreover, combination therapy is costly and may cause various adverse events.~     Therefore, individualized therapy based on outcome analysis should be adopted to save medical~     cost as well as to lessen inadequate treatment. Few studies are aimed to evaluate the host~     responses of micro RNA regulation during interferon-based therapy and its relationships to~     the overall treatment responses.~      Micro RNA (miRNA) is a single-stand RNA composed of 21-23 nucleotides, which may regulate the~     function of messenger RNA (mRNA). The regulating mechanisms involving micro RNA between the~     hosts and the HCV virus include (1) auto-regulation of HCV mRNA by HCV miRNA; (2) regulation~     of host mRNA by HCV miRNA; and (3) regulation of HCV mRNA by host miRNA. MiR-122 is the~     abundant liver-specific miRNA which is crucial for efficient HCV replication in culture Huh7~     cells stably expressing HCV replicons. Recently, an in vivo study for hepatic miR-122 of 42~     patients with CHC who received IFN-based therapy showed that patients who did not respond to~     IFN therapy had markedly decreased pretreatment miR-122 levels. Although miR-122 is abundant~     in the liver, liver biopsy is still considered an invasive procedure, which prevents its~     widespread use in routine clinical practice. The miRNA can be detected in the sera and is~     stable after 24 hours of room temperature store or repeated freezing and de-freezing. The~     serum miR-122 levels can reflect the severity of liver injuries in a rat acetaminophen~     toxicity model. Because miR-122 is liver specific and the miRNA is stable in the sera, the~     investigators aimed to evaluate the role of serum and hepatic miR-122 on the viral kinetics~     and the treatment responses and in HCV patients receiving peginterferon and ribavirin~     combination therapy.~   "
197338|NCT00980148|"~     Chlamydia is a common infection among youth and can be given from one person to another~     during sex. Many people who have chlamydia have no signs of infection at all, but can pass~     the infection to anyone they have sex with. If not treated, chlamydia can lead to serious~     health problems. This study will look at how well medicines given for chlamydia infection~     work. The study requires 306 evaluable subjects, chlamydia-positive, males and non-pregnant~     females, ages 12-21, living in long-term, gender-segregated youth correctional facilities.~     Participants will be assigned to receive either doxycycline (2 times per day, by mouth, for 7~     days) or azithromycin (1 single dose by mouth). Study procedures will include collection of~     at least 3 urine samples to test for chlamydia. Study visits will occur during initial~     enrollment in the study, day 28 after starting treatment, and day 67. Participants will be~     involved in study related procedures for up to 67 days.~   "
197339|NCT00980135|"~     The study shall prove whether treatment of atopic dermatitis is equally effective with~     Sinecort cream as compared to standard therapy (Hydrocortisone cream).~   "
197340|NCT00980122|"~     Cancer is the commonest cause of death in Singapore, and many cancer deaths occur in~     hospital.~      Management of cancer patients is getting more complex with constant development of new drugs,~     interventional procedures and supportive measures. Despite this, the majority of advanced~     cancer patients will die from their disease or related complications.~      There is a lack of data on the utilisation of health resources in advanced cancer patients in~     this country. In this study the investigators ask themselves how aggressive care was in the~     last 3 months of the patient's life. The investigators will be collecting data on specific~     cancer treatments, interventional procedures, and supportive measures.~   "
197341|NCT00980109|"~     This is a multicenter, randomised, four arms placebo controlled study to evaluate the safety~     and tolerability of 10 mg inhaled zanamivir once a day and 75 mg oseltamivir capsule orally~     once a day relative to placebo over 16 weeks (112 days). Enrolled subjects will be randomly~     assigned to 2:1:2:1 ratio (active oseltamivir: placebo: active zanamivir: placebo) on one of~     the four study treatment groups.~      It is hypothesized that oseltamivir and zanamivir will protect participants from becoming~     infected with influenza.~   "
197342|NCT00980083|"~     Synthetic GLP-1 lowers postprandial (pp) glycemia by stimulating insulin, inhibiting~     glucagon, and delaying gastric emptying. However, the effects of the endogenous peptide are~     largely unknown. Using the specific GLP-1 receptor antagonist exendin(9-39)amide (Ex(9-39))~     the investigators recently showed that GLP-1 released during intestinal meal perfusion acts~     as an incretin hormone and as an enterogastrone. As the relative contributions of these~     effects to controll postprandial glycemia are unclear, the investigators used Ex(9-39) to~     investigate the mechanisms of action of GLP-1 after an oral meal in humans.~   "
197343|NCT00980070|"~     This is a pilot study to evaluate a restraint device for lumbar punctures. Designed to help~     improve the restraint techniques for lumbar puncture, the restraint device will be compared~     to the current standard of manual physical restraint in neonatal and pediatric patients (age~     1 day to 90 days of life). The investigators will study 30 subjects, with 20 randomized for~     the experimental device and 10 randomized for the control group, which is current standard~     of care. The investigators' primary outcomes will include time of procedure, red blood cells~     in the cerebrospinal fluid as well as physician satisfaction. Subjects will be eligible if~     they are 1-90 days of life, and their treating physician believes lumbar puncture is~     indicated. There is no follow-up once the lumbar puncture has been completed and the data has~     been obtained.~   "
197344|NCT00980057|"~     The purpose of this study is to show that Adaptive CRT is at least as good at optimizing a~     patient's cardiac resynchronization therapy (CRT) as the current method of using an~     echocardiogram. Adaptive CRT (aCRT) is an implantable heart failure device feature that~     attempts to optimize CRT without echocardiographic testing.~   "
197345|NCT00980044|"~     Prescription opioid addiction is a growing public health problem and more pharmacologic~     treatments are needed because current approved medications have had limited patient~     acceptance (naltrexone), limited availability (methadone), and concerns about misuse and~     diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to~     treat moderate-severe pain, and initial studies demonstrate that it may be useful for~     treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric~     effects. This study will determine whether two different doses of extended release tramadol~     can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no~     longer taken.~   "
197346|NCT00980031|"~     The goal of this project is to investigate the effects that the addition of aldosterone~     blockade with eplerenone will have on the progression of diastolic dysfunction in patients~     with controlled essential hypertension.~   "
197347|NCT00980018|"~     The purpose of this exploratory study will be to examine changes in chronic low grade chronic~     adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading,~     when patients are switched from imatinib to nilotinib therapy.~   "
197350|NCT00979979|"~     Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma~     (HCC) and liver transplantation, affects approximately 170 million individuals worldwide.~     Combination of peginterferon plus ribavirin therapy has become the current standard of care~     for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR)~     rate of 54-63% and more favorable response rates in patients with genotype 2/3 infection than~     those with genotype 1/4 infection. Therefore, accurate pre-treatment HCV genotype evaluation~     is of paramount importance to facilitate individualized therapy in the era of response guide~     therapy and specific-targeted antiviral therapy for HCV (STAT-C).~      Currently, direct HCV genetic sequencing for both the 5' untranslated terminal region (5'UTR)~     and non-structural 5B (NS5B) regions with subsequent phylogenetic tree analysis is considered~     the gold standard for determining HCV genotype and subtype. However, it is time-consuming and~     need special laboratory settings. Several commercial available reverse hybridization with~     type-specific probing assay (Inno-LiPA II) or simplified direct sequencing of the 5'UTR~     region were used to replace the two region sequencing method (Trugene HCV 5' NC genotyping~     kit). Nonetheless, data on the overall diagnostic accuracy varied.~      The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain~     reaction (RT-PCR) assay for determining the genotype(s) of HCV in plasma and serum from~     HCV-infected individuals. Based on genetic similarity, HCV has been classified into six major~     genotypes (1-6) and numerous subtypes. HCV genotype is predictive of the response of~     HCV-infected patients to peginterferon plus ribavirin combination therapy. The Abbott~     RealTime HCV Genotype II assay uses the Abbott m2000sp instrument for processing samples and~     the Abbott m2000rt instrument for amplification and detection. Furthermore, the Abbott~     m2000sp provides automated sample transfer and reaction assembly of the assay reagents in the~     Abbott 96-Well Optical Reaction Plate.~      The investigators aimed to evaluate the overall diagnostic accuracy of the currently~     available commercial HCV genotype kits (Abbott RealTime HCV Genotype II) by using 5'UTR and~     NS5A gene amplification and direct sequencing as the gold standard.~   "
197351|NCT00979966|"~     This will be a prospective, open-label, randomized multicenter phase-II study to evaluate~     progression free survival (PFS) in patients with locally advanced or metastatic non-clear~     cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib.~      In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included~     exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in~     ncc-RCC showing interesting response rates for both agents. However, randomized clinical~     trials in this specific patient population have not yet been performed.~      In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line~     therapy of ncc-RCC.~   "
197352|NCT00979953|"~     The purpose of this study is to determine the efficacy of ADL5859 versus placebo and ADL5747~     versus placebo in relieving pain in participants with osteoarthritis of the knee.~   "
197353|NCT00979940|"~     This research study plans to evaluate the use of atorvastatin in patients with coronary~     artery disease given immediately before PCI and whether it will decrease the amount of heart~     damage after PCI.~   "
197354|NCT00979927|"~     The purpose of this study is to investigate the safety and tolerability of SPC3649 given in~     multiple doses to healthy volunteers.~   "
197355|NCT00979914|"~     Osteoarthritis is a common disease. The core treatment is often patient education. The aim of~     this study is therefore to study the effect of a patient education programme for patients~     with osteoarthritis in primary health care.~   "
197356|NCT00979901|"~     This study will evaluate the ability of montelukast to improve the signs and symptoms of~     seasonal allergic rhinitis compared with loratadine and placebo.~   "
197357|NCT00979888|"~     RATIONALE: Gathering information about how patients, caregivers, and healthcare professionals~     cope with symptoms caused by lung cancer, such as breathlessness, cough, fatigue, anxiety,~     depression, pain, and difficulty sleeping, may help doctors learn more about non-drug methods~     of treating symptoms of respiratory distress.~      PURPOSE: This clinical trial is studying how caregivers help patients cope with respiratory~     and other symptoms caused by lung cancer.~   "
197358|NCT00979875|"~     This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to~     determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of~     subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20~     (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone,~     insulin aspart + rHuPH20, and insulin aspart alone.~   "
197359|NCT00979862|"~     This phase I trial is studying the side effects and best dose of cediranib maleate when given~     together with cilengitide in treating patients with progressive or recurrent glioblastoma.~     Cediranib maleate and cilengitide may stop the growth of tumor cells by blocking blood flow~     to the tumor. Giving cediranib maleate together with cilengitide may kill more tumor cells.~   "
197360|NCT00979849|"~     The aim of the study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male~     subjects.~   "
197361|NCT00979836|"~     The objective of the study is to assess the efficacy of calcium dobesilate for treating~     chronic venous wounds.~      The hypothesis is that venous ulcers treated with standards measures (compressive measures)~     and calcium dobesilate will heal-up better than venous ulcers treated with standards measures~     (compressive measures) and placebo.~   "
197362|NCT00979823|"~     The objective of this translational research is to study the effect of implementing an~     innovative simulated diabetes learning intervention within primary care residency programs.~     The intervention uses cognitive behavioral learning theory to provide goal-directed feedback~     to residents after every encounter over a series of virtual patient-physician encounters.~     Formulas derived from pharmacokinetic data and the experience of clinical experts model~     simulated physiologic responses to drug changes, health behaviors, and adherence factors. The~     online intervention is economical, sustainable, and addresses a number of current obstacles~     to outpatient diabetes training in primary care residency programs.~      In this group trial, we randomly assign about 20 primary care residency programs with up to~     700 residents total to either an (a) Early learning program group or (b) Delayed learning~     program group. We will assess the ability of residents to achieve evidence-based diabetes~     clinical goals and avoid potential medical safety issues for glycemia, blood pressure, and~     lipids on simulated assessment cases. Secondary analyses will evaluate the actual use of the~     tool by residents, direct costs of the program, and resident satisfaction.~   "
197375|NCT00979654|"~     The objective of this study is to assess the safety and tolerability of sifalimumab in adult~     participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or~     polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or~     MI-CP179.~   "
197376|NCT00979641|"~     The purpose of this study is to evaluate the efficacy and safety of the combination of~     biweekly docetaxel and bevacizumab in the first line treatment of metastatic breast cancer by~     using Response Evaluation Criteria In Solid Tumors (RECIST criteria) and NCI Common~     Terminology Criteria for Adverse Events (NCI CTC-AE) version 3. In addition several~     biochemical makers are tested as possible predictive factors.~   "
197363|NCT00979810|"~     The purpose of this study is to evaluate high and low areas of growth, or proliferation,~     within the tumor. An imaging technique using a very small amount of a radioactive tracer~     called 18Ffluoro-deoxy-L-thymidine (18F-FLT) can detect areas of rapid growth within the~     tumor. This imaging technique is called a FLT PET imaging. This present study involves~     obtaining one scan using FLT PET imaging. The goal of this study is to investigate~     associations between the imaging findings showing differences in growth rate within the tumor~     and the biology of the tumor that is measured in the sampled tumor tissue. This information~     may be used in future brain tumor patients to determine the best combination of treatment for~     individual patients. These studies may also improve our understanding of the types of changes~     taking place in brain tumor tissue that could improve individual patient outcome. FLT is~     produced for human use by the MSKCC cyclotron facility under an investigational new drug~     (IND) approval issued by the US Food and Drug Administration (FDA). This means that FLT is~     produced under strict rules and regulations, is considered safe, and has been approved for~     use in humans for certain disease conditions. 18F-FLT has been used in several research~     studies to date at this institution.~   "
197364|NCT00979797|"~     The proposed four-year randomized study will attempt to test the hypothesis that~     community-based child health interventions in conjunction with facility-based IMCI will~     improve child care practices, nutritional status and child survival. The objectives of this~     research are:~        1. To measure the effectiveness of the community-based interventions in improving selected~          child care practices in the community.~        2. To measure the effectiveness of the community-based interventions in improving child~          nutritional status and in reducing child morbidity and mortality.~        3. To document the process of implementation of community-based interventions at scale to~          promote selected key family and community practices related to child health.~        4. To undertake cost-effectiveness analysis of the interventions.~      Integrated Management of Childhood Illness (IMCI) is a strategy developed by the World Health~     Organization (WHO) and UNICEF to reduce childhood mortality and morbidity and to contribute~     to improved growth and development of children under-5 years of age Experience suggests that~     a purely facility based strategy will not reach the significant portion of the population~     that does not have access to or choose not to use a health facility. Links between the~     service providers and families at household levels is essential in order to ensure that~     families have the knowledge, skills and ability to provide appropriate preventative and~     curative care to their children. However, globally, actual evidence of effectiveness of~     community-based IMCI interventions implemented at scale is meager.~      C-IMCI in Bangladesh will be implemented by GoB in partnership with NGOs and also through~     active participation of different community groups, civil societies, and the private sector.~      Both GoB and UNICEF/Bangladesh have agreed that an evaluation of the C-IMCI implementation by~     GoB, as proposed here, would be very opportune and useful in providing the evidence and~     analysis of lessons that will guide further scale-up in the country.~      A cluster-randomized design will be used for this evaluation. Fourteen Upazilas where~     facility-based IMCI is already in place will be selected, and 7 upazillas will be randomly~     allocated to C-IMCI intervention and 7 to comparison. Community-based IMCI in the~     intervention upazillas will be implemented by GoB through the district health system while in~     the comparison upazillas existing services will continue, including facility-based IMCI.~   "
197365|NCT00979784|"~     The hypothesis of this study is that overweight and obese patients exposed to sleep focused~     counseling and standard dietary and exercise counseling will have better outcomes than~     similar patients exposed to standard dietary and exercise counseling only.~   "
197366|NCT00979771|"~     The purpose of this study is to determine if GSK706769 can maintain clinical remission~     established by Enbrel after withdrawal of Enbrel in rheumatoid arthritis patients.~   "
197367|NCT00979758|"~     The benefit of current stem cell transplantation therapy for myocardial infarction is limited~     by low survival rate for stem cell. The purpose of this study is to test whether intensive~     Atorvastatin therapy can improve the outcome of patients with impaired left ventricle~     function after myocardial infarction who underwent intracoronary transfer of autologous bone~     marrow cells.~   "
197368|NCT00979745|"~     Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP~     sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating~     hormone (alpha-MSH) and is not yet available on the market.~      The purpose of this study is to look at whether afamelanotide can reduce the number and~     severity of EPP symptoms when patients are exposed to light. This study will also look at how~     the drug is tolerated when taken by people with EPP.~      The study will involve the use of an implant, which comes in the form of a small rod~     (approximately 2 cm x 0.15 cm) to be administered under the skin. The implant may contain the~     study drug afamelanotide or a placebo (inactive medication).~      Over 450 subjects have been treated with afamelanotide to date with no serious safety~     concerns identified. For this study, afamelanotide has been formulated as a controlled~     release depot injection (implant). This means that the afamelanotide will be released slowly~     into the body over a few days. Once inserted, the implant will remain in the body after~     afamelanotide has been released and will slowly dissolve.~      This study will help to provide more information about afamelanotide. This information will~     be used to determine the safety and efficacy (the ability of the drug to produce an effect)~     of this drug in EPP sufferers.~      Up to 70 people will participate in this study from study sites across Europe.~   "
197369|NCT00979732|"~     In this research study, the investigators are interested in learning how extracts from grape~     seeds can help those individuals with high blood pressure. The investigators also hope to~     learn how grape seed extract effects your blood and cell functions.~      The grape seed extract the investigators will use in the study will be provided either in a~     beverage or a capsule form and is currently available on the market. This study is also using~     a placebo; therefore the treatment subjects receive may or may not contain the grape seed~     extract.~      The purpose of this study is to determine if the grape seed extract (GSE) will lower blood~     pressure in people with slightly high blood pressure (Pre-Hypertension).~   "
197370|NCT00979719|"~     To help rehabilitation patients to adopt and maintain a physically active lifestyle, it is~     imperative to increase self-management competencies. Aim of this research project is to~     evaluate an evidence- and theory-based computerized expert system in comparison to a well~     established standard program and a questionnaire-only group. Rehabilitation patients will be~     treated psychologically and followed up over 18 months. The computerized expert system is~     expected to help patients better than the standard program. Both interventions are~     hypothesized to improve self-management competencies over and above the rehabilitation~     treatment (i.e., questionnaire-only group).~   "
197371|NCT00979706|"~     Pilot study for the treatment of primary HIV infection with the objective to induce a strong~     specific HIV immune response able to control viral replication without HAART.~   "
197504|NCT00977938|"~     The DAPT Study is a double blind randomized controlled trial intended to determine the~     appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second~     anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet~     therapy to protect patients from stent thrombosis and major adverse cardiovascular and~     cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents.~     Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated~     subjects.~   "
197377|NCT00979628|"~     High blood glucose levels in medical and surgery patients with diabetes are associated with~     increased risk of in-hospital complications and death. Improved glucose control with insulin~     injections may improve clinical outcome and prevent some of the hospital complications.~     Numerous studies have shown that high blood glucose increases the risk of wound infection,~     kidney failure and death. It is not known; however, what is the best insulin regimen in~     patients who will undergo surgery. The use of repeated injections of regular insulin is~     commonly used for glucose control in hospitalized patients with diabetes. Recently, the~     combination of Lantus® and Apidra® insulins has been shown to improve glucose control with~     lower rate of hypoglycemia (low blood sugar). The investigators' recent preliminary data also~     indicate that a single daily dose of glargine plus corrective doses of glulisine before meals~     if needed (Basal Plus) is effective in the management of medical and surgical patients with~     type 2 diabetes mellitus (T2DM). The average daily blood glucose (BG) levels in patients~     treated with Basal Plus is equivalent to levels in patients treated with Basal Bolus with~     glargine once daily plus glulisine before meals (basal bolus regimen). The mean daily BG~     levels in patients treated with basal plus are lower than those reported in patients treated~     with sliding scale regular insulin (SSRI). Accordingly, the present study aims to determine~     which insulin treatment is best for glucose control in hospitalized patients with diabetes~     admitted to general medicine wards. Glargine, glulisine, and regular insulins are approved~     for use in the treatment of patients with diabetes by the FDA.~   "
197378|NCT00979615|"~     The purpose of this study is to examine safety and efficacy of Patanase and Astelin in~     treating the symptoms of non-allergic vasomotor rhinitis (VMR).~   "
197379|NCT00979602|"~     The purpose of this study is to characterize the safety, immunogenicity, and relative~     efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of~     age or older.~   "
197380|NCT00979589|"~     The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel~     initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days~     versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke~     (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom~     onset in high-risk patients with TIA or minor stroke.~   "
197381|NCT00979576|"~     The objectives of this trial are to estimate the following in Japanese patients with advanced~     NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.~      Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD)~     of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500~     mg/m^2) and to determine the Recommended Dose (RD) for the phase II part.~      Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed~     (500 mg/m^2) as compared to pemetrexed (500 mg/m^2) + placebo~   "
197382|NCT00979563|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of~     OratecanTM. Eligible subjects of this study are patients with histologically or cytologically~     confirmed malignant solid tumor refractory to standard therapy or for which no established~     therapy exists at the time of study participation.~   "
197383|NCT00979550|"~     The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser~     treatment of vascular malformations.~   "
197384|NCT00979537|"~     The objective of this study was to investigate the bioequivalence of nisoldipine~     extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release~     40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg~     tablet) dose administration in healthy adult subjects under fed conditions.~   "
197385|NCT00979524|"~     This project's focus is twofold—to change the culture of an employment training program for~     adolescents and young adults (Youth Opportunities, or YO) to more fully address the many~     mental health issues faced by its participants and to expand and improve the quantity and~     quality of mental health services for YO members. Four project components have been carefully~     selected to address the mental health issues of YO members: (1) Mental health~     education/training for YO staff and peer leaders, (2) Mental health education activities for~     YO members, (3) mental health screening on all newly enrolling YO members, and (4)~     comprehensive mental health services for YO members. These project components will be~     implemented at the HEBCAC YO Program (subsequently referred to as Eastside YO), with the~     Westside YO Program initially participating as a control site. Researchers at the Johns~     Hopkins University Center for Adolescent Health, led by Dr. Darius Tandon of the Department~     of Pediatrics, will conduct the research examining the effectiveness of these mental health~     services and supports.~      There are four project objectives. First, the proposed activities will increase YO members'~     knowledge of mental health resources and decrease stigma associated with seeking mental~     health services. Second, the investigators will see an increase in YO members' receipt of~     needed mental health services. Third, the investigators will see improvement in YO members'~     mental health. Fourth, as a result of their improved mental health, YO members will more~     actively engage in YO program activities and achieve more key program milestones (e.g., GED~     completion). These objectives are sequential, with later objectives predicated on the~     achievement of earlier ones.~   "
197402|NCT00979290|"~     The fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or~     tablet are available to prevent the development of drug resistance. However, the fixed-dose~     combination regimen is not consistent with the dosages that are usually given. The present~     available FDC chemotherapy (Rifater) for pulmonary tuberculosis that is used in Taiwan has a~     higher ratio of isoniazid to rifampin and pyrazinamide. The higher risk of drug toxicity and~     adverse reactions when using fixed-dose combinations regimen should be considered. The aim of~     the present study is to compare the toxicity between using FDC regimen (Rifater/Rifinah) in~     Taiwan and single drugs in the treatment of newly diagnosed pulmonary tuberculosis. The~     investigators also evaluate the efficacy of two regimens and determine the incidence of~     discontinuation of TB drugs and the predisposed factors between two regimens.~   "
197505|NCT00977925|"~     The objective of this study is to evaluate the safety and hemostatic effectiveness of the~     Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe~     soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic~     surgery.~   "
197506|NCT00977912|"~     The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence~     of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.~   "
197386|NCT00979511|"~     Osteoporosis has been described as a paediatric disease with a geriatric outcome. This is~     because bone mass is acquired during youth and is progressively lost later in life, without~     symptom or pain, until a fracture occurs. The proper management of osteoporosis includes~     improving bone mineral content in the first two decades of life so that reserves are built up~     before bone loss ensues.~      The investigators aim to determine the effect of a 10-month school-based provision of~     high-calcium milk and weight-bearing exercise program on the bone mineral status among~     prepubertal girls. The investigators' study is novel since it seeks to determine the effect~     of these interventions in girls, whose overall risks are much higher for osteoporosis later~     in life, and in a developing country population whose calcium intakes are more likely to be~     depleted.~      The investigators hypothesize that provision of either high-calcium milk or weight-bearing~     exercises will improve bone mineral density among prepubertal girls but that the bone accrual~     will be greater among those with both interventions. In addition, the investigators~     hypothesize that the changes will be more marked among those whose calcium intakes are lower.~      This study will use a two-by-two factorial design of 1) high-calcium milk (1000 mg/day) vs.~     placebo (115 mg/day) and 2) weight-bearing exercises (a total of 90 to 150 minutes per week~     divided into 3 to 5 schooldays) vs. no-exercise (passive activities) in a randomized~     controlled trial, for a total of 4 intervention groups: calcium+exercise, placebo+exercise,~     calcium+no exercise, placebo+no exercise.~      The study will be conducted among 80 prepubertal girls (on Tanner stage 1), aged 7-9 years~     and enrolled in one primary school in one of the metropolitan cities in the Philippines with~     an institution or a hospital with a Lunar Prodigy Central dual-energy x-ray absorptiometry~     (DEXA) machine.~      Osteoporosis has no treatment. The problem will continue to become burdensome in the future~     since population aging per se will increase the risk and incidence of fractures.~     Understanding the relationship between calcium and exercise is important since the greatest~     benefit is in the paediatric age range. The study results could provide information on a~     workable intervention that promotes the multiple health benefits of both exercise and~     high-calcium milk to young children.~   "
197387|NCT00979485|"~     The purpose of this study is to provide data correlating levels of microparticles that~     circulate in the blood and disease activity in children with inflammatory bowel disease~     (IBD). The hypothesis is that circulating microparticles will be higher in children with~     active IBD, show inflammatory activity, and will be low in patients in remission as well as~     in healthy controls.~   "
197388|NCT00979472|"~     The purpose of the study is to compare the effect of solifenacin succinate between frequent~     micturition patients with urgency and those without urgency.~   "
197389|NCT00979459|"~     This study will assess the pharmacokinetics of two formulations of MK-1006. The primary~     hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum~     concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and~     film coated tablet (FCT) formulations of MK-1006 will be similar.~   "
197390|NCT00979446|"~     Numerous modifiable lifestyle factors have been identified that may affect the risk of older~     adults developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Evidence~     suggests that interventions to reduce risk factors and enhance protective factors would be~     beneficial in slowing cognitive decline and decreasing the risk of incident MCI and AD. The~     overall objective of this pilot study, funded as a supplement to Keep Active Minnesota (KAM)~     (03-024; R01-AG023410) is to develop and test the feasibility of conducting a multi-domain~     intervention to maintain cognitive health in adults ages 60-80 with the goal of reducing the~     incidence of and slowing progression to MCI and other more severe forms of cognitive decline.~   "
197391|NCT00979433|"~     The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in~     a greater proportion of infants being successfully extubated when compared with management~     with ventilator derived CPAP.~   "
197392|NCT00979420|"~     The question that prompted this study is the extent to which results from clinical trials can~     be translated into everyday practice (external validity). An observation period of about 10~     years extends far beyond the duration of clinical trials. First and foremost are questions~     about tolerability and the efficacy of an antiretroviral combination treatment with Viramune~     and other antiretroviral partners. In particular, adverse events will be recorded and the~     therapeutic effect will be monitored via the course of viral load and improvement of the~     immune system, based on the CD4 cell count.~   "
197393|NCT00979407|"~     The primary purpose of the study is to assess the equivalence of the immune response elicited~     by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and~     GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate~     the safety and reactogenicity of these two vaccines.~   "
197394|NCT00979394|"~     This registery should show the medical care of patient with Type 2 Diabetes (T2D) at~     GP-offices. Furthermore data of co morbidities and risk factors should be evaluated.~     Objectives of this NIS (cross-sectional study) are:~        -  To evaluate which characteristics or co-morbidities are being existent for patient with~          T2D at GP level,~        -  To evaluate representative profile of patient with T2D in Austria,~        -  To evaluate which medical therapies are used.~   "
197395|NCT00979381|"~     In this study the researchers investigate the influence of the tyrosine kinase inhibitors~     sunitinib and sorafenib, on the normal humoral and cellular immuno response to influenza~     vaccination in patients with metastases of renal cell carcinoma or a GIST.~   "
197396|NCT00979368|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics~     following single oral doses of BMS-816336 in healthy male subjects.~   "
197397|NCT00979355|"~     A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an~     imaging modality for general nuclear medicine applications such as oncology.~   "
197398|NCT00979342|"~     The purpose of this study is to develop a recommended local anesthetic protocol and~     post-treatment pain management regimen, in order to assure patient comfort during~     office-based treatment with the MyoSure Hysteroscopic Tissue Removal Device. Subject~     self-reported pain scores (as rated on an 11 point scale) will be compared at multiple time~     intervals between all treatment groups.~   "
197399|NCT00979329|"~     The purpose of this study is to assess the influence of Sunitinib and Sorafenib on fatigue,~     quality of life and depression in patients with metastatic renal cell or colorectal cancer or~     GIST. In order to get more insight in the mechanism of vascular endothelial growth factor~     (VEGF) related fatigue and if possible to come to a resolution for this side effect.~   "
197400|NCT00979316|"~     The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT~     interval corrected for heart rate).~   "
197401|NCT00979303|"~     The purpose of this study is to determine whether the additional use of non-fluoroscopic~     imaging modalities can decrease the use of radiation exposure during standard ablation~     procedures for supraventricular tachycardia (SVT) in children.~   "
197525|NCT00977639|"~     The pathworks tissue of origin test is a microarray-based test with the goal of identifying~     the tissue of origin in patients with metastatic tumors of unknown primary site.~   "
197403|NCT00979277|"~     Recent studies from both human and mice cancer models have demonstrated a crucial role for~     monocytes/macrophages in contributing to cancer progression and disease prognosis. However,~     since each cancer subtypes is associated with a unique tumor microenvironment in terms of its~     anatomical location, cytokine/chemokine profiles and stromal components, the functional~     contribution of tumor infiltrating cells such as the monocytes/macrophages can be equally~     diverse, depending on the type of cancer. Therefore to obtain a global understanding of the~     role of host immune cells in cancer progression, it is necessary to accurately characterize~     these cells in the context of the tumor microenvironment for several cancer subtypes rather~     than a single cancer. In view of this, this pilot proposal aims to carryout a systems~     approach in characterizing the functional phenotype of monocyte/macrophage lineage in 4~     diverse human cancer types [e.g., Colorectal Cancer, Nasopharyngeal carcinoma, Hepatocellular~     (liver) cancer and Renal cell carcinoma (kidney cancer)] and the molecular basis of~     tumor-induced immunosuppression in each of these conditions. Besides providing a global view~     of the host innate immunity and its molecular basis in these human cancer, the outcome of~     this investigation will be crucial in defining the scopes of specific immunotherapy~     strategies to overcome tumor-induced immunosuppression and induce~     monocyte/macrophage-mediated antitumor response.~   "
197404|NCT00979264|"~     The objective of this study is to evaluate whether a quarterly feedback, education and~     performance improvement site-based intervention has a greater impact on quality performance~     and adherence to evidenced-based guidelines than existing on-demand feedback. This study will~     use a randomized design to compare changes in quality performance and adherence to selected~     measures among hospitals using existing on-demand reports and general quality improvement~     (QI) efforts versus those receiving intensive, targeted QI feedback via reports,~     teleconferences, webinars, and specialized tool kits.~   "
197405|NCT00979251|"~     This Phase 2, open label, randomized study will investigate the virologic benefit, clinical~     efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus~     oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised~     adult and pediatric subjects.~   "
197406|NCT00979238|"~     The purpose of this study is to determine the safety of giving a normal factor IX gene to~     treat individuals who have an abnormal or no factor IX gene. Recruitment will be limited to~     adults (≥ 18 years) with a confirmed diagnosis of hemophilia B (HB), resulting from a~     missense mutation in the coagulation factor IX (FIX) gene or a nonsense mutation that has not~     been associated with an inhibitor. Only subjects who have no evidence of active hepatitis or~     anti-hFIX antibodies, and who have been treated/exposed to Factor IX concentrates for at~     least ten years and have had an average of 3 bleeding episodes per year requiring FIX~     administration will be enrolled. Patients will be recruited within the United States for~     treatment at St. Jude Children's Research Hospital, and patients will be recruited in England~     and other countries for treatment in London by our British collaborators.~   "
197407|NCT00979225|"~     This three-year, grant funded project will be conducted by the Division of Clinical~     Informatics in the Department of Community and Family Medicine at Duke University Medical~     Center. The project seeks to improve care quality and safety in an ambulatory care setting~     through clinical decision support for evidence-based (EB) pharmacotherapy delivered as~     point-of-care reports to clinic-based practitioners and as population health-based alerts to~     care managers.~      This project will build upon a regional Health Information Exchange (HIE) network created to~     connect providers serving 37,000 Medicaid beneficiaries from both rural and urban settings in~     a 5 county region in the Northern Piedmont of North Carolina. This network includes 16~     private practices, 3 federally qualified health centers, 5 rural health centers, 3 urgent~     care facilities, 10 government agencies, 5 hospitals, and 2 cross-disciplinary care~     management teams.~      The proposed information system will be based on an emerging standard for decision support~     and will utilize routinely available claims and scheduling data in order to serve as a~     replicable model for broader use of decision support for medication management. Increased~     availability and use of decision support tools for medication management can be expected to~     reduce medication errors, improve health care quality at an acceptable cost, and augment~     disease management for patients and populations.~   "
197408|NCT00979212|"~     RATIONALE: Drugs used in chemotherapy (CT), such as paclitaxel and carboplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy (RT) uses high-energy x-rays to kill tumor cells.~     Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving these treatments before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is~     not yet known whether chemotherapy and radiation therapy are more effective when given with~     or without panitumumab in treating patients with non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy to see~     how well they work when given with or without panitumumab in treating patients with stage~     IIIA non-small cell lung cancer.~   "
197409|NCT00979199|"~     Main purpose of the study:~      To comparatively assess the diagnostic performance of non invasive anatomical and functional~     imaging modalities to detect significant obstructive coronary artery disease as demonstrated~     at invasive coronary angiography and functional evaluation of coronary lesions (fractional~     flow reserve).~   "
197410|NCT00979186|"~     The study will document being able to successfully perform transgastric cholecystectomy~     (laparoscopic visualization) using a small collection of study surgical tools.~   "
197436|NCT00978822|"~     This study is designed to assess how rapidly and how safely Clevidipine can be used to~     control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain~     bleed that happens because of a weak balloon like structure in one of the brain vessels.~     Control of blood pressure is of high value in preventing this balloon that ruptured and bled~     from rebleeding. The ultimate cure would be to shut down the aneurysm by a surgical~     procedure. Clevidipine is a drug that can lower blood pressure and it is given through the~     vein as a continuous infusion. It is a very short acting drug which is important in~     controlling labile blood pressure condition with rapid changes between up and down. This~     trial will test for its rapid actions and check for any side effects and possibly any other~     potential benefit.~   "
197411|NCT00979173|"~     The primary objective is to evaluate the intratumoral and plasma pharmacokinetics of AC480~     among patients who are candidates for a resection with a recurrent malignant glioma who are~     not on CYP-3A enzyme inducing anti-epileptic drugs (EIAEDS). Secondary objectives include the~     following: to evaluate the antiproliferative effect of AC480 by FDG-PET Scan; to evaluate the~     safety and tolerability of AC480; and, to describe 6-month progression-free survival (PFS)~     and radiographic response.~      This is a single institution, open label, pharmacokinetic study of AC480 in patients with~     recurrent malignant glioma. The study will enroll 5 patients who are not on enzyme inducing~     anti-epileptic drugs (EIAEDs) and are scheduled to undergo salvage surgical resection for~     preoperative treatment with AC480 at 300 mg orally twice daily (BID) for 14 (plus or minus 2)~     days before surgery (Part I- Induction Therapy). After surgery (Part II- Maintenance~     Therapy), patients will continue to be dosed with AC480 until disease progression or~     intolerance, and will be evaluated after every other cycle (1 cycle is 28 days).~   "
197412|NCT00979160|"~     This is a multicenter, open-label, single arm phase II non-randomized study of dasatinib in~     which subjects with systemic mastocytosis (SM) will be treated with a continuous regimen of~     dasatinib.~      Upon completion of a treatment induction period, subjects will be treated with dasatinib at a~     dose of 100 mg per os (OS) once daily (QD).~   "
197413|NCT00979147|"~     This study is designed to compare prospectively, in a randomized Level 1 evidence fashion,~     the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray~     with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT)~     design with GVF polyethylene. Comparing these two designs will afford us information in the~     following areas:~        1. Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF~          design?~        2. Is there a clear clinical advantage to the MPT/XLK design in certain patient populations~          that justify its use over the APT/GVF design?~      Answering these questions will allow surgeons to use both designs appropriately in different~     demand populations.~      This study is designed to address the questions of whether an MPT/XLK design offers~     improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic~     measures, over an APT design. The investigator's primary hypothesis is that there will be no~     difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis~     based on the long-term follow-up of this group, up to twenty years, is that there will be no~     difference in implant survival.~   "
197414|NCT00979134|"~     This study is primarily designed to assess the safety and tolerability of AZD4547 at~     increasing doses in patients with advanced solid malignancies and for whom no standard~     medication options are available. It also assesses the blood levels and action of AZD4547 in~     the body over a period of time.~   "
197415|NCT00979121|"~     Objective: assess the efficacy and safety of oral rosuvastatin in patients with~     sepsis-induced Acute Lung Injury (ALI).~      Hypothesis: Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.~   "
197416|NCT00979108|"~     The purpose of this study is to determine the effectiveness of adding mechanical traction to~     standard physical therapy treatments for patients with neck and arm pain.~   "
197417|NCT00979095|"~     The investigators are performing a genetic study of patients with multiple hernias (at least~     3 primary hernias) versus a healthy control group. This genetic information is compared with~     circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's).~      The hypothesis is that patients with multiple hernias have different expression of specific~     genes compared to the healthy control group.~   "
197418|NCT00979069|"~     The purpose of this study is to see if exercise can improve brain function in older adults~   "
197419|NCT00979056|"~     The aim of the study is to investigate the efficacy of the prophylactic treatment with~     rifaximin to prevent travellers diarrhoea.~   "
197420|NCT00979043|"~     The primary purpose of this study was to determine the effect of dietary weight-loss,~     exercise training, or a combination of both on physical function in overweight and obese~     adults with knee osteoarthritis (OA). In secondary analyses, the effect of weight-loss and/or~     exercise on OA progression, self-reported pain and inflammation were examined. In post-trial~     analyses, the effect of dietary weight-loss on total mortality was determined.~   "
197421|NCT00979017|"~     The primary objective of the study is to determine the efficacy of Avastin in combination~     with temozolomide and irinotecan in terms of response rate. The secondary objectives are to~     describe the overall and progression-free survivals of unresectable patients treated with~     upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin,~     temozolomide and irinotecan in unresectable glioblastoma patients.~      This is a phase II study with the combination of Avastin, temozolomide and irinotecan for~     unresectable or multifocal World Health Organization (WHO) grade IV malignant glioma~     patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan.~     Approximately 41 subjects will take part in this study at Duke.~   "
197422|NCT00979004|"~     Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic~     stimulation (IPS) will participate. Four subjects will be enrolled at each dose level and~     will receive a single dose of placebo and a single dose of ICA-105665 during the study, each~     followed by intermittent photic stimulation. The effects of ICA-105665 on the photoparoxysmal~     electroencephalography (EEG) response of each group will be reviewed before the dose is~     selected for each subsequent group of subjects.~   "
197423|NCT00978991|"~     The proposed project is aimed to build a Duke University-specific longitudinal urologic~     surgery database. It will be used as the main resource to support future research within~     Urology and Duke University.~   "
197424|NCT00978978|"~     Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional~     sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with~     liver diseases. The investigators' working hypothesis is that the use of propofol will be~     translated in a shorter recovery and discharge times with a higher patient satisfaction and a~     decrease in general complications in the context of patients with advanced liver disease.~   "
197437|NCT00978809|"~     The propose of this study is to compare two methods of physical treatment for benign~     paroxysmal positional vertigo, by evaluating treatment effects on postural stability.~      The trail design is a double blinded randomized controlled trail, with each patient going~     through three evaluations: before treatment, 1 week after treatment and 60 days after~     treatment.~   "
197425|NCT00978965|"~     This study is designed to define groups of patients (among patients with a heart or kidney~     graft or a glomerular disease and nephrotic range proteinuria) who would either not profit~     from a therapy with mycophenolate-mofetil (MMF) or need a higher than conventional dose to~     respond.~      Mainly there are 2 possible explanations for inter-patient differences in responsiveness to~     MMF therapy:~        1. Based on a mutation (in this study single nucleotide polymorphisms-SNPs-) in the inosine~          monophosphate dehydrogenase 2 (IMPDH 2) transcript as the target enzyme of mycophenolic~          acid (MPA) pathway, MMF cannot exert its effect.~        2. Based on a high enzyme activity of IMPDH 2 a higher MMF dose than in the conventional~          regimens is needed.~      To study the significance of these possible explanations there are 4 objectives in this~     study:~      Objective 1: Since there are no data on SNPs with functional relevance in IMPDH 2 transcript,~     we will first sequence all 14 exons of this gene in their entirety in 100 gender and age~     matched healthy individuals.~      Objective 2: The functional relevance of a detected SNP will be tested in vitro in a~     lymphocyte proliferation assay using various MPA concentrations.~      Objective 3: These functionally relevant SNPs will be searched in patients with kidney graft~     in a retrospective as well as prospective manner.~      Objective 4: Parallel to the genotyping experiments, IMPDH 2 activity and MPA plasma levels~     will be measured in all patients recruited in the study prospectively.~      An association between these SNPs or various IMPDH 2 activity / MPA plasma levels with MMF~     responsiveness will be examined.~      Objective 5: Strongyloides IgG titers are screened to evaluate the prevalence of helminth~     carriers in patients with immunosuppressive therapy.~   "
197426|NCT00978952|"~     This study is designed as a prospective, multicenter, non-randomized, single arm study to~     assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for~     stent implantation in coarctations of the aorta.~   "
197427|NCT00978939|"~     Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous~     pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency~     of pleural drainage and, if so, whether catheter-related complications can be minimized and~     spare patients the need for long term management of the Pleurx® catheter.~   "
197428|NCT00978926|"~     The well-established role of vascular endothelial growth factor (VEGF) in carcinogenesis and~     tumor angiogenesis has led to the development of agents that target this pathway. Anti-VEGF~     agents the VEGF monoclonal antibody bevacizumab, and the small molecule VEGF receptor~     tyrosine kinase inhibitors. Angiogenic factors play a key role in the maintenance of lung~     integrity and normal endothelial function. Endothelial dysfunction has been implicated in~     hypertension, proteinuria and retinopathy. One of the major issues of anti-VEGF agents is its~     long-term toxicity especially taking into account the lack of adequate knowledge in this area~     and the possibility of prolonged periods of therapy in non-progressing patients. Hypertension~     and proteinuria are commonly seen in patients treated with anti-VEGF agents. In addition, the~     investigators have also observed in a relatively high frequency of pulmonary air-filled~     lesions in patients with malignancy in the lung treated with an anti-VEGF agent. Objectives~     of this exploratory study are to 1) determine the effect of anti-vascular endothelial growth~     factor (VEGF) on endothelial function 2) determine endothelial dysfunction as a marker of~     early response and as an indicator for the development of hypertension and proteinuria 3)~     characterize the effect of anti-VEGF therapy on the pulmonary function of patients with~     malignancy (primary or secondary) involving the lung in patients treated with anti-VEGF~     agents. Pharmacodynamic endpoints to be assessed are: blood pressure, brachial artery~     reactivity, retinal microvessels, microalbuminuria and proteinuria, pulmonary function,~     assess the effects of anti-VEGF therapy by assessing brachial artery reactivity, retinal~     vasculature and pulmonary function in a subset of patients receiving anti-VEGF therapy. The~     development of markers of endothelial dysfunction may result in the early identification of~     patients who are non-responders or develop toxicity from anti-VEGF treatment.~   "
197429|NCT00978913|"~     The primary aim of this study is to evaluate the toxicity of the vaccine and the combination~     of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the~     vaccine. The secondary aim is to investigate the clinical tumour response and duration of~     tumour and immune response.~   "
197430|NCT00978900|"~     The purpose of this study is to examine the influence of artificial sweeteners (aspartame,~     acesulfame K, sucralose) and carbohydrate sugars (glucose, fructose) on the release of~     gastrointestinal satiety hormones in humans.~   "
197431|NCT00978887|"~     The purpose of the study is to assess the efficacy of Retorna facial cream usage in the~     reduction or total correction of facial wrinkles. The duration of this double-blind placebo~     controlled phase 3 clinical trial will be 4 weeks. The estimated number of women to be~     recruited and randomized for the study is 148. Occurrence of adverse effects will also be~     evaluated.~   "
197432|NCT00978874|"~     RATIONALE: Diagnostic procedures, such as fluorine F 18 EF5 PET/CT imaging, may help find~     oxygen in tumor cells. It may also help doctors predict a patient's response to treatment and~     help plan the best treatment.~      PURPOSE: This phase I trial is studying fluorine F 18 EF5 PET/CT imaging to see how well it~     works in finding hypoxia in tumor cells of patients with locally advanced or~     recurrent/metastatic cervical cancer.~   "
197433|NCT00978861|"~     The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.~   "
197434|NCT00978848|"~     The purpose of this study is to determine the prevalence and treatment rates of T. vaginalis,~     C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine~     pregnancy testing in the Magee-Womens Hospital outpatient clinic using a non-invasive urine~     STD test.~   "
197435|NCT00978835|"~     Diabetes and hypertension co-exist in approximately 10 million people in the USA and~     constitute severe risk factors for the development of such complications as heart and kidney~     disease. The investigators propose a randomized controlled trial in patients of community~     primary care practices to study a tailored telephone-administered behavioral intervention to~     improve control of blood pressure and blood sugar in patients with both hypertension and~     diabetes. The investigators hypothesize that 20% more patients talking to a nurse every other~     month about ways to improve blood pressure and blood sugar control will bring their blood~     pressure under control when compared to patients who talk with the nurse only about general~     health issues. If successful in improving control of these diseases this intervention can~     easily be adopted in other community primary care practices to lessen the burden of diabetes~     and hypertension in the USA.~   "
197438|NCT00978796|"~     The purpose of this study is to determine the effects of sitagliptin on glucose variability~     both after meals and overnight in adult patients with type 1 diabetes.~   "
197527|NCT00977613|"~     Given the apparent effect of 18 metabolic equivalent task-hours of activity/week in improving~     disease free survival in patients with treated stage 3 colon cancer and the survival benefit~     of exercise demonstrated in patients with stage II and III colorectal cancer, the primary~     objective is to evaluate compliance at 6 months with post-treatment recommendations for a~     minimum of 18 metabolic units of physical activity each week in patients who have completed~     therapy for stage 2 and stage 3 colorectal cancer.~   "
197439|NCT00978783|"~     Background:~      Many patients with respiratory failure related to neuromuscular disease receive chronic~     invasive ventilation through a tracheostomy. Improving quality of life, of which speech is an~     important component, is a major goal in these patients. The investigators compared the~     effects on breathing and speech of low-level positive end-expiratory pressure (PEEP, 5 cm~     H2O) and of a Passy-Muir speaking valve (PMV) during assist-control ventilation.~      Methods:~      Flow will be measured using a pneumotachograph. Microphone speech recordings were subjected~     to both quantitative measurements and qualitative assessments; these last consisted of a~     perceptual score and an intelligibility score determined by two speech therapists using a~     French adaptation of the Frenchay Dysarthria Assessment.~   "
197440|NCT00978770|"~     RATIONALE: Diagnostic procedures such as MRI scans may help predict early response to~     treatment in patients with breast cancer undergoing chemotherapy.~      PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in~     patients with locally advanced breast cancer.~   "
197441|NCT00978757|"~     The purpose of this study is to determine whether ketamine is effective to inhibit~     interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.~   "
197442|NCT00978744|"~     The Shared Health CHR™ (Clinical Health Record) offers point-of-care clinical reporting and~     decision support based primarily on patient claims data aggregated across various health care~     settings, and is one example of the types of health information data exchange efforts being~     implemented across the country. This study will evaluate how the CHR is used and its clinical~     and financial impact to better understand the CHR's value, and to identify opportunities to~     enhance the system to support patient care and practice efficiency. In addition, the results~     from this study will help to inform the national debate about the effectiveness of these~     types of tools to maximize patient quality of care, patient safety, and practice efficiency.~   "
197443|NCT00978731|"~     To determine the long term safety and tolerability of dasatinib exposure in subjects~     previously treated in CA180-002.~   "
197444|NCT00978718|"~     RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in~     patients at high risk of prostate cancer. It is not yet known which dose of selenium may be~     more effective in preventing prostate cancer.~      PURPOSE: This randomized phase III trial is studying how well selenium works in preventing~     prostate cancer.~   "
197445|NCT00978705|"~     The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.~   "
197446|NCT00978692|"~     The aims of this study are to investigate the effects of ortho-k for astigmatic and myopic~     reduction and myopic control in children, and the long term effects on corneal curvatures and~     biomechanics.~   "
197447|NCT00978679|"~     The primary objective of the current study is to investigate changes in peripheral refraction~     and aberration in children wearing orthokeratology lenses and single-vision spectacles.~   "
197448|NCT00978666|"~     The purpose of this study is to use fMRI imaging technology to examine areas in the brain~     related to appetite, reward and cognition in adolescent women with eating disorders as~     compared to those who have never had an eating disorder. Better understanding biologic~     vulnerabilities in women with anorexia is essential for developing more effective treatment~     options.~   "
197449|NCT00978653|"~     In this prospective study, the investigators aimed to evaluate the effects of improved~     hyperuricemia, a minor cardiovascular risk factor, on endothelial dysfunction in patients~     with chronic kidney disease.~   "
197450|NCT00978640|"~     Hypothesis: during fasting and exercise will there be an activation of sirtuins (Sirt1).~      Primarily the investigators will investigate Sirt1 activity in muscle- and fat-biopsies after~     fasting for 36 hours and after 1 hour of ergometer-cycling at 50 Vo2max.~      In addition to this the investigators will investigate the effect of fasting and exercise on~     the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.~   "
197451|NCT00978627|"~     This trial is conducted in Europe, Oceania, and the United States of America (USA).~      The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart~     (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes~     (main period) followed by the extension period comparing the long-term safety of NN5401 plus~     insulin aspart with insulin detemir plus insulin aspart.~      The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension~     period is registered as NN5401-3645.~   "
197452|NCT00978614|"~     Primary:~        -  To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at~          therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc~          interval) in healthy male and female subjects.~      Secondary:~        -  To assess the pharmacokinetics [PK] of neramexane and N-OH neramexane (if a validated~          method will be available for this metabolite) following repeated daily doses of 50 mg~          (steady state), 75 mg (steady state) and 87.5 mg (steady state).~        -  To assess the safety and tolerability of neramexane 50 mg, 62.5 mg, 75 mg and 87.5 mg~          repeated-dose treatments when gradually up-titrated in healthy subjects.~        -  To assess the concentration-QT relationship.~   "
197453|NCT00978601|"~     The purpose of this study is to evaluate a multimodal analgesic protocol used in minimally~     invasive surgery for myomectomies (laparoscopic myomectomy (LM) and laparoscopically assisted~     myomectomy (LAM)).~   "
197454|NCT00978588|"~     Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for~     cardiopulmonary bypass~   "
197455|NCT00978575|"~     The trial is a double-blind randomized trial designed to examine whether compliant iron~     therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more~     and faster than no treatment - in patients with acute bleeding from upper gastrointestinal~     tract. The trial will include 126 patients at Aarhus University Hospital. In addition to~     efficacy assessment quality of life assessment and health economic calculations between the~     treatments will be compared.~   "
197477|NCT00978289|"~     The purpose of this study is examine the relationship between adipose tissue inflammation and~     activation of the endocannabinoid system before and after Roux-en-Y gastric bypass surgery.~     The investigators hypothesize that the metabolic improvements and weight loss are due to~     mechanisms that antagonize the endocannabinoid system.~   "
197528|NCT00977600|"~     To determine the safety and tolerability of single oral doses of HPN-100 as a formulation~     (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy~     male subjects.~   "
197456|NCT00978562|"~     This clinical trial studies dynamic susceptibility-weighted contrast enhanced magnetic~     resonance imaging (DSC-MRI) after administration of ferumoxytol and dynamic contrast-enhanced~     MRI (DCE-MRI) after administration of a gadolinium-based contrast agent (GBCA) in viewing the~     vessels of the brain in younger patients with brain tumors. Ferumoxytol is an experimental~     form of very small iron particles that are taken by the blood stream to cells adjacent and~     inside the tumor. These iron particles may make it easier to see the areas of the brain that~     are affected by tumor. Ferumoxytol may work better than standard GBCA in viewing the vessels~     of the brain and brain tumor on MRI. Using ferumoxytol and GBCA in the same MRI session may~     provide more information about tumor blood supply and the extent of the tumor.~   "
197457|NCT00978549|"~     RATIONALE: Analgesics, antiemetics, steroids, and radiation therapy are effective in helping~     to control symptoms caused by cancer. It is not yet known whether these treatments are more~     effective when given with or without docetaxel in treating patients with relapsed esophageal~     cancer or stomach cancer.~      PURPOSE: This randomized phase II trial is studying symptom control given together with~     docetaxel to see how well it works compared with symptom control given without docetaxel in~     treating patients with relapsed esophageal cancer or stomach cancer.~   "
197458|NCT00978536|"~     In multiple sclerosis (MS) sub cortical cognitive impairments are frequently reported.~     Nevertheless, cortical cognitive troubles, with hippocampic memory troubles have been~     described. Besides inflammatory damage, early cortical and degenerative damage are well~     known. In neurodegenerative diseases, three biomarkers of the cerebro spinal fluid (CSF),~     reflecting lesional mechanisms, are measured: the beta amyloid peptide, the tau total~     protein, and the phospho tau protein. Preliminary studies shown increased level of tau in MS.~     No study compare cognitive impairment and biomarkers of CSF.The aim of this study is to~     measure in the CSF of MS patients these three biomarkers (beta amyloid peptide, tau total and~     phosphotau) in order to establish correlations between a profile of biomarkers and a pattern~     of cognitive troubles, cortical or subcortical.The possibility to show, in MS patients with~     memory hippocampic troubles, a profile of biomarkers closed from the one encountered in AD,~     could argue in support of the degenerative hypothesis in MS and lead to discuss the interest~     of the use of AD treatment in MS.~   "
197459|NCT00978523|"~     The primary objective of this study in adults with advanced or recurrent solid tumors or~     lymphoma is to evaluate the safety and tolerability of AR-12 by describing dose-limiting~     toxicities (DLTs), and thereby establishing the maximum tolerated dose (MTD) or, in the~     absence of reaching an MTD, a recommended dose (RD) for additional study of oral AR-12~     administered daily in cycles of 28 days (28 consecutive days of once daily treatment with at~     least a 7-day break between the first and second treatment cycles and recovery of toxicity to~     grade 1 or less, with no planned off-treatment days between subsequent cycles).~   "
197460|NCT00978510|"~     The purpose of this study is to evaluate in hospital environment the knowledge of the health~     care professionals about fundamental concepts on tuberculosis and the accomplishment to~     respiratory isolation practices for patients with pulmonary tuberculosis hospitalized in a~     public hospital in Fortaleza, Ceará, Brazil.~   "
197461|NCT00978497|"~     The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598~     when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared~     to placebo + SOC.~   "
197462|NCT00978484|"~     Therapy that uses Virtual Reality (VR) has been shown to help in the treatment of Post~     Traumatic Stress Disorder (PTSD). It is unclear what role the VR simulator itself plays in~     recovery. This study is examining if full-immersion in VR causes greater improvement in PTSD~     symptoms than does similar therapy that uses a simple, static, computer image.~   "
197463|NCT00978471|"~     Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to~     20% are metastatic.~      Further to the initial standard care, about 45% of the patients relapse within a median~     duration of 20 months.~      Result of the OS94 study results and of the investigation performed within the CRLCC,~     indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each~     year in FRANCE.~      According to several studies, the 5-year overall survival rate of patients in first relapse~     is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are~     also reported in the COSS study, with a median time to second relapse of 0.8 year.~      At present, there is no reference treatment for the standard care of osteosarcoma relapse in~     FRANCE.~      Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study~     from our institution reported that about 35% of all osteosarcoma relapses are treated with a~     high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never~     been assessed.~      These results highlight the need to the evaluate the efficacy and tolerance of this high-dose~     of thiotepa within a clinical trial and its inclusion in the standard care of the~     osteosarcoma at relapse.~   "
197464|NCT00978458|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known whether radiation therapy is~     more effective when given together with or without temozolomide in treating patients with~     low-grade glioma.~      PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it~     works when given together with or without temozolomide in treating patients with low-grade~     glioma.~   "
197478|NCT00978276|"~     The purpose of this study is the identification and classification of human tissues and~     cytology specimens and elements therein.~      Computer aided technology to assist the pathologists to identify, quantify, characterize and~     report their findings with regards to one or more diagnoses they should perform. In~     particular and for example: the scoring of the number of elements and their protein~     (antibody) expression level within a paraffin embedded tissue section.~   "
197479|NCT00978263|"~     The investigators designed this prospective, randomized control study to compare the efficacy~     and safety between the basal insulin glargine therapy and metformin-based OADs after~     correction of the glucose toxicity with a short period of intensive insulin therapy.~   "
197612|NCT00976495|"~     The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as~     assessed by glomerular filtration rate.~   "
197465|NCT00978445|"~     Long-term anticoagulation is indicated in patients for the prophylaxis and/or treatment of~     the thromboembolic complications associated with atrial fibrillation and/or mechanical~     cardiac valve replacement, prevention or treatment of venous thromboembolism (deep vein~     thrombosis and pulmonary embolism), to prevent thromboembolic events post-myocardial~     infarction, and in patients with systemic embolic events. Currently the only approved oral~     medication for anticoagulation is warfarin (Coumadin, Bristol-Myers Squibb and generic~     warfarin. Dosage is controlled by periodic determinations of the prothrombin time~     (PT)/International Normalized Ratio (INR). Under treatment may lead to venous or arterial~     thrombotic events or stroke, while over treatment may lead to major bleeding and even death.~     Patients require frequent INR monitoring to maintain a therapeutic level of anticoagulation.~     The therapeutic INR range varies by clinical indication, most commonly an INR 2-3 goal, but~     ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of~     4.0. The vMetrics - Anticoagulation Management System is a remote patient management solution~     for Oral Anticoagulation Care patients. This system provides confirmation of patient question~     and testing protocols as well as virtual patient management care capability for dosage and~     patient scheduling. This trial will provide end points to ascertain efficiency against~     standard care protocol and confirm equivalent care standards.~   "
197466|NCT00978432|"~     The purpose of this study is evaluate the response, safety and tolerability in subjects~     receiving the investigational drugs, RAD001 and LBH589. Subjects in Part 1 will receive one~     drug for four cycles followed by 4 cycles of the second drug unless they achieve complete~     remission. Subjects in a complete remission may receive up to 6 cycles of study drug and will~     not receive the next study drug until there is evidence of disease progression. Subjects in~     Part 2 will receive both drugs together for at least 2 cycles and up to 13 if tolerated.~   "
197467|NCT00978419|"~     This is a 90 day study, with patients receiving either oral Rosuvastatin or placebo for up to~     28 days. The study will assess the affect of statins administered soon after burn injury on~     C-reactive protein (CRP) levels, patient mortality and the incidence of septic shock. The~     investigators also seek to describe the correlation between exposure to statins and~     development of delirium and de-novo long-term cognitive impairment.~      Hypothesis:~        1. Statin administration within 96 hours of burn is safe, will decrease CRP, and will~          decrease septic shock and mortality in burn patients.~        2. The investigators hypothesize that burn patients will have a de-novo long term cognitive~          impairment at 3 months after burn.~        3. The investigators hypothesize the use of statins in burn patients will reduce the~          development and the degree of cognitive impairment at 3 months post burn.~   "
197468|NCT00978406|"~     Information about Americans food choices and opinions helps researchers and law makers to~     develop policies and programs to promote health. For this reason, it is important to be able~     to collect good quality information about how people think about food. This project will~     compare different ways of collecting information about food from adults.~   "
197469|NCT00978393|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate~     liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a~     two-period, six-sequenced, crossover trial where the trial participant will enter two~     treatment periods with a wash-out period of 6-8 weeks.~   "
197470|NCT00978380|"~     This trial is conducted in Asia, Europe and North America. The aim of the trial is to~     investigate the safety of monthly replacement therapy of recombinant factor XIII in patients~     with congenital FXIII deficiency. The trial continues until the product is commercially~     available, but an interim assessment will take place when all subjects have completed 52~     weeks in the trial.~   "
197471|NCT00978367|"~     The purpose of this study is to investigate the dosing frequency, wound healing~     (re-epithelialisation) and anti-scarring effects of one, three and five applications of two~     concentrations of intradermal RN1001 in healthy male subjects.~   "
197472|NCT00978354|"~     Acute renal failure, now referred to as acute kidney injury, is common in intensive care unit~     patients, contributes to high morbidity and mortality, and has no proven interventions with~     benefit once established. In addition to supportive care, these patients frequently receive~     diuretic therapy, most commonly furosemide.~      Prior trials showed no impact of furosemide on clinical outcomes and perhaps harm, however,~     these trials suffered from numerous limitations and lack applicability to modern intensive~     care unit patients. As a result, there appears a disconnect between clinical practice and~     available evidence. Survey data supports the view of clinical equipoise for use of furosemide~     in intensive care unit patients with early acute kidney injury. Moreover, these data also~     confirm there is an urgent need for higher quality and more definitive evidence from~     randomized trial on furosemide use in early acute kidney injury.~      Accordingly, the investigators propose to conduct a pilot phase II randomized, blinded,~     placebo-controlled trial comparing furosemide to placebo in ICU patients with early acute~     kidney injury.~      The specific aims of this study are:~        1. To compare the efficacy and safety of a continuous infusion of furosemide versus placebo~          titrated to the physiology parameter of urine output in early acute kidney injury on the~          primary outcome of progression in severity of kidney injury in intensive care unit~          patients with early AKI and stratified by the presence of sepsis.~        2. To evaluate selected secondary endpoints on the impact of furosemide versus placebo,~          specifically: fluid balance goals; electrolyte and acid-base balance; the need for renal~          replacement therapy (i.e. dialysis); total duration of acute kidney injury; the rate of~          renal recovery; and mortality.~        3. To compare the impact of furosemide versus placebo on the trajectory of serum and~          urinary biomarkers (neutrophil gelatinase-associated lipocalin [NGAL], interleukin-18~          [IL-18]) and evaluate whether these biomarkers perform superior to conventional measures~          (creatinine, urea) for monitoring the progression of kidney injury and the prediction of~          outcome.~      This trial represents part of a larger initiative aimed towards expanding our understanding~     of the treatment of acute kidney injury in intensive care unit patients and evaluating~     interventions that may potentially reduce kidney injury and improve clinical outcomes.~   "
197473|NCT00978341|"~     The study is designed to assess if spinal cord injury patients have reduced pain after taking~     either pregabalin or placebo in a cross over design. Patients had either pain at the level of~     their injury or below the level of their injury.~   "
197474|NCT00978328|"~     The purpose of this study is to describe clinical and demographic characteristics of patients~     receiving prescription medications containing oxycodone immediate release (OXYRX), to~     characterize patient and prescriber perceptions of the effectiveness outcomes and~     tolerability of OXYRX treatment, to describe prescriber decision-making about pain management~     with a Schedule II opioid and to explore how prescribers identify suspected abuse of pain~     medications.~   "
197475|NCT00978315|"~     The study null hypothesis is that vitamin D supplementation will not influence time to upper~     respiratory tract infection or time to severe asthma exacerbation in adult and adolescent~     patients with asthma.~   "
197476|NCT00978302|"~     The purpose of this study is to determine the safety and local toleration and histological~     effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male~     volunteers.~   "
197480|NCT00978250|"~     Background:~        -  Two experimental drugs, FdCyd (also called 5-fluoro-2'-deoxcytidine), and THU (also~          called tetrahydrouridine), are undergoing trials to test their effectiveness in treating~          cancer that has not responded to standard therapies. FdCyd is thought to work by~          changing how genes work in cancer cells. THU does not have any anticancer effects on its~          own, but it helps keep the other drug, FdCyd, from being broken down by the body.~        -  These drugs are being tested on several separate clinical trials.~      Objectives:~        -  To determine if FdCyd and THU can work together to control tumor growth.~        -  To evaluate the safety and tolerability of FdCyd and THU when given together.~      Eligibility:~      - Individuals 18 years of age and older who have advanced non-small cell lung cancer, breast~     cancer, bladder cancer, or head or neck cancer that has progressed after receiving standard~     treatment or for which no effective therapy exists.~      Design:~        -  The drugs are given over 28-day periods called cycles. FdCyd and THU are given through a~          vein for about 3 hours each day on days 1 5 and 8 12 of each cycle.~        -  Clinical Center visits: FdCyd and THU will be given through a vein each day on days 1 5~          and 8 12 of each cycle. During the Clinical Center visits, researchers will perform~          study tests and procedures to see how the study drugs are affecting the body.~        -  Patients will undergo a number of tests and procedures during the treatment cycle,~          including physical examinations, blood and urine samples for standard tests, imaging~          studies (ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) scans)~          to evaluate tumor growth, and blood and urine samples to evaluate the amount of FdCyd~          and THU in the body and the body's response to the drugs.~        -  Patients may continue to receive FdCyd and THU if their cancer does not grow, if they do~          not have too many side effects, and if they are willing to do so.~   "
197481|NCT00978237|"~     Eligible HIV-infected patients with clinically evident lipoatrophy despite treatment with~     efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and~     asked to enroll in the study; will be randomized (1:1) into two branches, A: EFV + Fixed~     combinations of analogue tenofovir + emtricitabine.B (experimental): LPV/r + combination of~     correspondent analogues. The main variable is the evaluation of the absolute change in limb~     fat mass at 24 months from baseline in both groups.~   "
197482|NCT00978224|"~     The purpose of the study is to determine whether Viusid administration improves malnutrition,~     atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects~     with Chronic Inflammatory Syndrome under hemodialysis treatment. The duration of this~     double-blind placebo controlled phase 3 clinical trial will be 60 weeks. All patients~     enrolled in the study will be receiving the standard treatment for Chronic Inflammatory~     Syndrome including hemodialysis and administration of a hypercaloric and hyperproteic diet.~     Efficacy assessment will be carried out 12 weeks after the end of Viusid or placebo~     treatment.~   "
197483|NCT00978211|"~     The investigators aim to explore the efficacy of [90Y-DOTA]-TOC and [177LuDOTA]-TOC therapy~     in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and~     long-term safety profile of systemic [90Y-DOTA]-TOC and [177LuDOTA]-TOC treatment in~     metastasized neuroendocrine cancer patients. Adverse events are assessed according to the~     criteria of the National Cancer Institute. Survival analyses are performed using multiple~     regression models.~   "
197484|NCT00978198|"~     The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single~     or multiple oral administration in healthy non-elderly adult male subjects.~   "
197485|NCT00978185|"~     RATIONALE: Acupressure wristbands may prevent or reduce nausea caused by chemotherapy. It is~     not yet known whether acupressure wristbands are more effective than standard care in~     controlling acute and delayed nausea.~      PURPOSE: This randomized phase III trial is studying acupressure wristbands to see how well~     they work compared with standard care in controlling nausea caused by chemotherapy.~   "
197486|NCT00978172|"~     The present study aims to investigate and to assess possible neurological and~     neuropsychiatric events in young children in west Africa with uncomplicated P. falciparum~     malaria after a 3-day treatment of Artequin Paediatric under real life conditions.~   "
197487|NCT00978159|"~     Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in 30%~     of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper endoscopy~     to exclude peptic ulcer disease or gastric cancers. For those without significant lesions in~     the stomach and duodenum (non-ulcer dyspepsia), the best approach in the management is~     unclear. The objective of this study is to compare the efficacy of esomeprazole and~     famotidine in the control of dyspeptic symptom. After giving consent, patients will be~     randomised to receive either esomeprazole 20 mg daily or famotidine 40 mg daily in a double~     blinded manner. The patient will be followed-up at the 2nd and 4th week. The study will be~     completed at the 4th week. The primary analysis will be the efficacy in the control of~     dyspepsia symptom between the two groups.~   "
197488|NCT00978146|"~     The purpose of this study is to examine the response rate of desmoid tumors to hydroxyurea.~     The investigators hypothesize that hydroxyurea will be a safe, non-toxic alternative to~     aggressive surgery or chemotherapy for this difficult to treat tumor.~   "
197489|NCT00978133|"~     2-octylcyanoacrylate (2-OCA) has been used extensively in clinical practice in trauma,~     plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. Most studies on~     2-OCA to date have focused on closure of short wounds, and only one has included closure of~     abdominal wounds in the context of general surgery. Here, the investigators will look at the~     results of closure of abdominal wounds in patients undergoing elective colectomies with~     2-OCA, which is commercially available to us, versus closure with skin staples, which is the~     current standard technique of skin closure employed in the Department of Colorectal Surgery,~     Singapore General Hospital. The primary objective was to measure effectiveness of 2-OCA in 2~     respects - the adequacy of wound healing and cosmesis, and the incidence of superficial wound~     infection.~   "
197490|NCT00978120|"~     The purpose of this study is to assess the safety and the body's immune response (body's~     defense against disease) to an experimental H1N1 influenza vaccine in people with asthma. The~     study will enroll 350, and possibly up to 400 healthy adults ages 12 and older with mild,~     moderate, or severe asthma. Participants will be randomly assigned to 1 of 2 possible vaccine~     groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1~     vaccine given as two 15 mcg injections. Both groups will receive vaccine injections on days 0~     and 21.~      Study procedures include: medical history, physical exam, spirometry, maintaining a memory~     aid and, and blood sample collection. Participants will be involved in study related~     procedures for approximately 7 months.~   "
197491|NCT00978107|"~     This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous~     intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of~     5-fluorocytosine in patients with primary or secondary hepatic tumors.~   "
197613|NCT00976482|"~     The study objective is to collect mid-term clinical outcome in a group of patients implanted~     with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and~     international environment.~   "
197492|NCT00978094|"~     Primary hypotheses:~      Ho1: In chronic neck pain patients, randomly treated with either a sham or real cervical~     manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal~     to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness~     will remain unchanged following the treatment procedure for both groups.~      Secondary (null) hypotheses:~        1. Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will~          remain unchanged in both groups;~        2. there will be no differences between groups with respect to 2a) neck joint cavitations~          and 2b) forces across the cervical spine measured during the manoeuvres.~   "
197493|NCT00978081|"~     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a~     certain kind of light. When the drug is active, tumor cells are killed.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of~     photodynamic therapy in treating patients with premalignant or early stage head and neck~     tumors.~   "
197494|NCT00978068|"~     HIV and malaria are major causes of morbidity and mortality in Sub-Saharan Africa and~     children bear the greatest brunt of both diseases. No single existing intervention is likely~     to control malaria in Africa. Rather, improvements in malaria prevention are likely to come~     from strategies that employ multiple proven interventions targeting different populations.~     HIV-infected children represent one of the most vulnerable subpopulations in these countries.~     It is possible that the use of protease inhibitor (PI) - based antiretroviral therapy (ART)~     in HIV-infected children living in areas of high malaria transmission could prevent malaria~     in this vulnerable population. An effective remedy that offers the possibility to further~     reduce malaria risk, such as PIs, is highly desirable. This study will determine whether a PI~     based ART regimen will reduce malaria among children living in a malaria endemic area of~     Uganda and receiving insecticide-treated bed nets (ITN) and TS. This study will compare two~     different ART regimens. Children enrolled in the study will start or continue to receive~     either standard Ugandan first line treatment ART regimen (NNRTI+2 NRTIs) or an ART regimen~     containing the HIV protease inhibitor (lopinavir/ritonavir +2 NRTIs) and followed for a~     period of 24 months.~   "
197495|NCT00978055|"~     The objective of this study was to investigate the bioequivalence of Mylan's liothyronine~     sodium 50 mcg tablets to King's Cytomel® 50 mcg tablets following a single, oral 100 mcg (2 x~     50 mcg) dose administration under fasting conditions.~   "
197496|NCT00978042|"~     Multicenter, single-blind, randomized, no-treatment control study to demonstrate the safety~     and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct~     age-related volume deficit in the mid-face.~   "
197497|NCT00978029|"~     The purpose of this study was to assess the safety and tolerability of a ragweed allergy~     immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years~     of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.~   "
197498|NCT00978016|"~     The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986)~     versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite~     therapy with approved doses of a Proton Pump Inhibitor (PPI).~   "
197499|NCT00978003|"~     Background:~        -  Patellofemoral pain syndrome is one of the most common knee problems. It is~          characterized by pain in the front of the knee that is aggravated by deep knee flexion,~          prolonged sitting, and repetitive movement. The most widely accepted theory regarding~          the source of this pain is that a force imbalance around the knee puts extra stress on~          the area, leading to pain.~        -  Researchers are interested in learning more about the muscle groups around the knee to~          better understand the causes of knee pain.~      Objectives:~      - To obtain more information on how muscles, tendons, and bones work together to cause motion~     in the knee, both in the normal state and after immobilizing certain muscles around the knee.~      Eligibility:~      - Healthy individuals between the ages of 18 and 55, who have no current or chronic muscle,~     bone, or joint problems and who have no implants or other problems that would prevent them~     from receiving a magnetic resonance imaging (MRI) scan.~      Design:~        -  This protocol will be carried out over two visits, both of which will involve using~          standard MRI sequences to look at the knee at rest and in motion.~        -  The first part will examine the knee under its natural state, with a standard MRI scan~          of the knee both at rest and in motion.~        -  The second part will involve temporarily reducing the force producing capabilities of~          one of the extensor muscles in the knee. To do so, study doctors will inject lidocaine~          into the muscle, which will temporarily (for approximately 2 hours) block the force~          producing capacity of this muscle, and then perform the MRI scan.~   "
197500|NCT00977990|"~     Background:~        -  Polyomavirus are DNA-based viruses that infect vertebrates, including humans. Most~          people are not harmed by polyomavirus infection, but people with compromised immune~          systems may be harmed by these viruses, and are at greater risk for developing certain~          types of rare cancers.~        -  A recently discovered virus called Merkel cell polyomavirus (MCV) is a type of skin~          infection commonly found in humans. By using skin swabs to collect MCV, researchers hope~          to develop a laboratory culture model of MCV for future research.~      Objectives:~      - To use skin swabs to collect samples of Merkel cell polyomavirus for future study.~      Eligibility:~      - Individuals 18 years of age and older who are employed in the National Cancer Institute's~     Laboratory of Cellular Oncology.~      Design:~        -  Participants will wipe a cotton swab across their forehead and eyebrows, and break off~          the end of the swab into a microcentrifuge tube. This procedure will be performed after~          work hours.~        -  No other treatment or procedure will be given as part of this protocol.~   "
197501|NCT00977977|"~     Background:~        -  Membranous nephropathy is associated with damage to the walls of the glomeruli, the~          small blood vessels in the kidneys that filter waste products from the blood. This~          damage causes leakage of blood proteins into the urine and is associated with low blood~          protein levels, high blood cholesterol values, and swelling of the legs. These problems~          can decrease or go away without treatment in about 25 percent of patients, but if they~          persist, some patients may experience impaired (or loss of) kidney function, blood~          vessel and heart disease, and a risk of forming blood clots in veins.~        -  Kidney biopsies that show that antibodies have been deposited along the glomeruli~          suggest that specialized cells of the immune system, called B and T cells, are causing~          damage to the kidneys through their increased activity. To suppress the action of B and~          T cells and to decrease the harmful deposits in the kidneys, drug treatments are~          required.~        -  Patients with membranous nephropathy are often treated with immunosuppressive drugs such~          as cyclosporine or cytoxan plus steroids that attempt to reduce or suppress the activity~          of the immune system, decrease antibody production, and reduce antibody deposits in the~          kidney. However, not everyone responds to these medications and the kidney disease can~          return in some patients when the drugs are stopped. Also, there are side effects~          associated with long term usage of these medications. Rituximab, a different~          immunosuppressant, has also been used for this purpose. Although cyclosporine and~          Rituximab have been used separately, they have not been tried in combination as a~          possible treatment for membranous nephropathy.~      Objectives:~      - To determine the safety and effectiveness of combining rituximab and cyclosporine to treat~     membranous nephropathy.~      Eligibility:~      - Individuals 18 years of age and older who have been diagnosed with membranous nephropathy~     based on a kidney biopsy done within the preceding 24 months, and who have had excess levels~     of protein in the urine for at least 6 months based on urine and blood tests.~      Design:~        -  Potential participants will be screened with an initial clinic evaluation and full~          medical history.~        -  Before the treatment, there will be a run-in period that will last up to 2 months.~          During this time, participants will be placed on a blood pressure lowering medication~          and will not take any other immunosuppressant medications.~        -  Participants will visit the NIH clinical center for a baseline evaluation, four~          intravenous infusions of rituximab, and also at 1- to 6-month intervals throughout the~          study.~        -  Active treatment period will involve a 6-month course of cyclosporine and a total of~          four doses of rituximab. Participants will take cyclosporine tablets twice daily, and~          have two infusions of rituximab given 2 weeks apart, After 6 months, the cyclosporine~          dose will slowly be decreased over several weeks and then completely discontinued.~          Participants will then receive another course (two doses 2 weeks apart) of rituximab,~          depending on results of blood work.~        -  Participants will have frequent blood and urine tests performed to monitor the results~          of treatment and reduce the chance of side effects.~   "
197502|NCT00977964|"~     The primary objective of this study is to assess the comparative gastrointestinal (GI)~     tolerance of normal term infants to six experimental milk protein-based powdered infant~     formulas.~   "
197503|NCT00977951|"~     The purpose of this study is to further determine the safety and toleration of intradermal~     avotermin (Juvista), confirm accelerated healing and investigate genomic expression profiles~   "
197614|NCT00976469|"~     The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza~     vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of~     immunogenicity and safety.~   "
197507|NCT00977899|"~     Background:~        -  Malaria, a disease transmitted by mosquitoes, affects millions of people with the~          highest frequency, morbidity, and mortality in infants and young children. Plasmodium~          falciparum and Plasmodium vivax, the most common and severe forms of malaria, have host-~          and stage-specific proteins that can induce immunity to the disease.~        -  Vaccines against stages that infect mosquitoes will prevent the spread of malaria.~          Researchers have developed a vaccine composed of a single protein, Pfs25, to induce~          antibodies in the human host that will be ingested by the mosquito and prevent the~          malaria parasite from reproducing and stop transmission of the disease. Because Pfs25 is~          present only in the mosquito, humans do not develop antibodies to this antigen even in~          endemic areas. Repeated injections of this vaccine may be necessary.~      Objectives:~      - To establish the safety and optimal dosage of a malaria vaccine developed with the Pfs25~     protein.~      Eligibility:~      - Healthy adults between 18 and 49 years of age who have never had malaria or received a~     malaria vaccine.~      Design:~        -  Two doses of Pfs25 conjugate (10 micrograms and 25 micrograms) will be evaluated in this~          study. Participants will receive only one of these doses in order to provide the best~          scientific data for evaluation.~        -  To determine eligibility, participants will provide a medical history and have a~          physical examination, and will provide blood and urine samples to test for HIV/AIDS,~          hepatitis, and other conditions that would prevent them from participating.~        -  Eligible participants will receive one injection of the vaccine. The injection will be~          followed 30 minutes later with a temperature reading and an inspection of the vaccine~          site.~        -  Upon leaving the clinic, participants will receive diary forms, a digital thermometer, a~          ruler, and instructions about how to take their temperature and to measure redness and~          swelling (if any) at the injection site. About 6 hours later, and daily for 3 days,~          participants will take their temperature at home and examine the injection site.~          Participants will be examined at the clinic at 48 to 72 hours and on day 7 after an~          injection. A blood sample will be taken 1 week after immunization. - Participants will~          receive a second and third injection of the same vaccine at 6-week intervals, and will~          follow the same recording procedure given above. Further blood samples will be taken at~          regular intervals for up to 12 months after the vaccination, as directed by the study~          researchers.~   "
197508|NCT00977886|"~     The purpose of this trial is to study the safety and tolerability of repeated oral doses of~     ELB353, to evaluate the plasma levels of ELB353 and to study their effect on substances~     mediating inflammation.~   "
197509|NCT00977873|"~     The study null hypothesis is that vitamin D supplementation will not influence time to upper~     respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive~     pulmonary disease.~   "
197510|NCT00977860|"~     The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts,~     the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity~     observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free~     Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at~     2 years following hypofractionated stereotactic body radiation therapy for low and~     intermediate risk prostate cancer.~   "
197511|NCT00977847|"~     In the 21st century, the importance of family health history will increase as it will be~     essential to put detailed personal genetic information into the context of an individual's~     health, namely the context of how the shared code has played out in an individual and his/her~     closest relatives. These scientific developments in the investigators' understanding of~     genetics will demand a more comprehensive family history dataset for all patients, and the~     time limitations on healthcare providers demand a technology-driven solution that integrates~     an individual's knowledge of their family history with the medical records maintained by~     their health care providers. A solution does not currently exist by which most Americans can~     organize their family health history and then place it into their electronic health record~     (EHR). The investigators propose to develop and compare three different ways of proactively~     collecting family history information from patients using computer technology independent of~     a health care visit, including telephone (interactive voice response technology), tablet~     computers in a physician's waiting room, and a secure internet portal at home. These tools~     will be based on the US Surgeon General's My Family Health Portrait, an electronic family~     history collection tool. Family history data will be transferred and integrated with a~     patient's EHR in a large primary care network. This project will seek to demonstrate that~     family history data can be accurately reported by diverse patients using these technologies,~     and that these data can be integrated to tailor an individual's health care based on their~     familial risk.~   "
197512|NCT00977834|"~     The purpose of this study is to evaluate the possibility of using a computer-based survey to~     gather information from older patients and their caregivers about the patient's daily~     activities, need for assistance, other medical problems, mood, nutrition and symptoms.~     Researchers will evaluate how many subjects are able to complete the survey on their own and~     the length of time needed to do so. Also, researchers will analyze the types of responses to~     each item and whether subjects are satisfied with the questionnaire.~   "
197513|NCT00977821|"~     For an efficient egg banking system, an equally efficient cryopreservation strategy that~     ensures the viability of the oocytes is required. Very recently, improved and new methods are~     yielding satisfactory results. In particular, vitrification is providing excellent results~     for both survival and clinical outcomes. However, to evaluate the over all out come there are~     other parameters to be considered. In this sense, capacity development of embryos generated~     after oocyte vitrification is a major factor when assessing the viability of vitrified~     oocytes. Accordingly, the evaluation of the capacity of vitrified oocytes to reach the~     blastocyst stage will be highly valuable to fully assess the effectiveness of the egg~     banking and its contribution to ovum donation programs.~      The aim of this study is to evaluate the developmental capacity of vitrified oocytes by their~     ability to reach the blastocyst stage. The study includes oocyte donation cycles conducted~     with vitrified versus fresh oocytes.~   "
197514|NCT00977808|"~     This study plans to link two existing technologies, the insulin pump and the continuous~     glucose monitor (CGM), to essentially develop an artificial pancreas, i.e., closed-loop. This~     will be done using two continuous glucose monitors (CGMs), a computer containing an~     investigational control algorithm that uses glucose information from the CGM to recommend~     insulin dosing, and an insulin pump. The purpose of this study is to test the ability of~     continuous glucose monitors together with an insulin pump and a mathematical formula to~     control blood sugar levels of people with type 1 diabetes.~      The Closed-Loop control algorithm will:~        1. Suggest adequate insulin delivery for blood glucose control in steady state (overnight);~        2. Cover adequately with an insulin bolus the pre-set carbohydrate content of a breakfast.~      If successful, this study will conceptually prove the feasibility of automated~     model-predictive closed-loop glucose control in T1DM.~   "
197526|NCT00977626|"~     Three-part study investigating the safety and tolerability of AZD2423 multiple doses in 98~     healthy volunteers: Part 1 80 young and elderly subjects in a parallel, double blind,~     randomised study. Part 2 - 6 subjects in an open, non-randomised study. Part 3 - 12 subjects~     in a three-way cross over, open label, partially randomised study.~      Part 1 has 2 Arms, AZD2423 or Placebo, Multiple dosing during 10-14 days . Part 2 has 1 Arm~     AZD2423 Multiple dosing and Part 3 has 3 Arms AZD2423 single dosing or AZD2423 single dosing~     with food or AZD2423 single dosing, Fasting Condition~   "
197515|NCT00977795|"~     Extent of resection is a very important prognostic factor affecting survival in individuals~     diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma~     tumor cells produces indistinct borders between normal and malignant tissues, and the lack of~     easily identifiable tumor margins confounds attempts at total resection. The investigators~     propose to identify the borders of malignant gliomas intraoperatively using oral~     5-aminolevulinic Acid (5-ALA) which results in fluorescence of the malignant cells and~     thereby provide an opportunity for more complete tumor resection.~      When exogenous 5-ALA is provided at increased concentration the tumor cells will become~     fluorescent under ultraviolet light. This feature identifies the tumor cells intraoperatively~     and facilitates complete resection.~      The following data will be collected:~        -  Dose-limiting toxicity data~        -  Tumor fluorescence assessed by neurosurgeon (0 to +++) in three distinct areas of~          fluorescence (Strong fluorescence, Weak fluorescence, No fluorescence)~        -  Tumor density from biopsies obtained by the neurosurgeon in the same three distinct~          areas of fluorescence and assessed by neuropathology (Solid tumor, Tumor mixed~          infiltrating normal brain, No tumor)~        -  Neurosurgeon's intra-operative estimate of residual tumor~        -  Neuroradiologist's estimate of post-operative residual tumor on MRI~        -  Time to progression by MRI~        -  Survival (time to progression, one year survival rate and total survival~      This trial will evaluate:~        -  The toxicity of a single dose of oral 5-ALA given pre-operatively.~        -  The sensitivity and specificity of 5-ALA - Protoporphyrin IX (Pp IX) as an~          intraoperative fluorescent detection agent and aid for resection of tumor tissue~          remaining in the walls of the resection cavity of primary and recurrent malignant brain~          tumors.~        -  The relationship of the neurosurgeon's estimate of the extent of malignant glioma~          resection (as guided by tumor fluorescence) to the actual extent of resection determined~          by post-operative imaging.~        -  The time-to-progression, one year survival rate and total survival as a function of the~          extent of resection.~      Following completion of the phase 1 portion of this trial, an additional 15 subjects will be~     entered at the recommended phase 2 dose level in order to further define the above parameters~     at the recommended phase 2 dose level.~   "
197516|NCT00977769|"~     A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with~     hemodynamic response as a primary outcome measure.~   "
197517|NCT00977756|"~     This study will examine drug and body interactions in children receiving anti-HIV treatment~     regimens using new medications. Drug regimens to be examined will feature the medications~     raltegravir (RAL), maraviroc (MVC), and etravirine (ETV). These drugs will not be provided~     through the study.~   "
197518|NCT00977730|"~     The purpose of this study is to evaluate the effect of Protandim on the degree of liver~     injury after one year of supplementation. Protandim is a nutritional supplement composed of~     the following 5 botanical extracts: Bacopa Moniera extract, Milk Thistle extract, Ashwagandha~     powder, Green tea, and Turmeric extract. Protandim is commercially available and can be~     purchased without a prescription. Our findings could lead to a better understanding of the~     role of oxidative stress and antioxidant therapy in NASH and may ultimately help improve~     patient care.~      Hypothesis #1: Protandim will lead to a significant improvement in NAS compared to placebo.~      Hypothesis #2: Protandim will lead to a significant decrease in serum markers of oxidative~     stress and liver chemistry tests.~      Hypothesis #3: Protandim will lead to decreased levels of TNF- α compared to placebo.~   "
197519|NCT00977717|"~     In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based~     chemotherapy, germinal gene polymorphisms will be analyzed.~   "
197520|NCT00977704|"~     This is an open-label study to assess safety using Restylane and Perlane in the correction of~     facial wrinkles.~   "
197521|NCT00977691|"~     Background:~        -  Bone marrow transplantation (BMT), which involves transplanting a donor s marrow stem~          cells, is capable of curing some congenital anemias. BMT usually involves high-intensity~          treatment with chemotherapy and radiation to kill abnormal cells, which affects all~          systems of the body.~        -  People with anemias often have damage to other organs such as the kidneys, which can be~          further damaged by the chemotherapy. Only approximately 20 percent of patients have a~          full-matched donor, making treatment for many people with anemias unavailable. However,~          90 percent of patients may have a half-matched donor, but using a half-matched donor~          increases the toxicity of BMT.~      Objectives:~        -  To determine if a research BMT with half-matched donor cells, low-intensity radiation,~          immunosuppressant drugs, and no chemotherapy will be effective in patients with sickle~          cell disease and Beta-thalassemia.~        -  To determine the effectiveness of cyclophosphamide, an immunosuppressant drug, in~          preventing rejection of the donor cells.~      Eligibility:~        -  Recipients are individuals at least 18 years of age who have been diagnosed with sickle~          cell disease and Beta-thalassemia, and who have a family member who is a haploidentical~          (i.e., half match) tissue match.~        -  Donors are healthy individuals between the ages of 2 and 80 who are found to be suitable~          donors.~      Design:~        -  Donors will undergo apheresis, which involves withdrawing blood from one arm vein,~          passing it through a machine that removes bone marrow stem cells, and returning the~          remaining blood through the vein in the other arm. Donors will receive a drug that~          causes the stem cells to be released into the bloodstream prior to the apheresis~          procedure.~        -  Recipients will undergo routine physical and laboratory examinations, including bone~          marrow sampling at the beginning of the study. After transplantation, physical and~          laboratory examinations will occur on a weekly or twice weekly basis at the outpatient~          clinic. Recipients will be examined every 6 months starting 100 days posttransplant for~          5 years.~        -  Recipients will receive low-dose radiation in two treatments 1 and 2 days before the~          transplant. They will also be given immunosuppressant therapy with alemtuzumab and~          sirolimus. Another immunosuppressant drug, cyclophosphamide, will be given in the future~          as needed to subsets of the recipients to prevent rejection of donor cells.~        -  Recipients will receive the donor stem cells through a previously inserted central line.~          The process takes up to 8 hours.~        -  Recipients will receive blood transfusions as necessary to prevent anemia and bleeding~          during the posttransplant period. They may also receive intravenous antibiotics to~          prevent infection.~   "
197522|NCT00977678|"~     The capacity for endoscopical procedures in the Norwegian health system is low in comparison~     to demands from patients and family practitioners.~      The studies aim is to evaluate the acceptance of a new concept: an open access gastroscopy~     clinic where patients can attend without a preceding appointment.~      The investigators wish to evaluate:~        1. Patient´s satisfaction.~        2. General practitioner´s satisfaction.~        3. Acceptance by the staff of the clinic.~   "
197523|NCT00977665|"~     To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.~   "
197524|NCT00977652|"~     Fecal incontinence is a major public health issue since 10% of the French population aged 45~     has to deal with it. Different treatments exist and have already been evaluated, like the~     sacral nerve stimulation (SNS) which has proved to be efficient in 75 to 100% of the anal~     incontinence patients without significant sphincteric lesions or rectal prolapse. However,~     the treatment is expensive and can have side effects. Moreover, about 20 to 30% of the~     patients can develop a resistance to the SNS only a few months following the definite~     implantation. Yet the development of the posterior tibial nerve stimulation (PNTS) offers a~     new perspective. It consists in stimulating the same metameric area as the sacral nerves. It~     is regularly used for the treatment of urinary incontinence caused by overactive bladder. It~     is a non-invasive technique, causing but a few side effects. A preliminary study showed that~     7 in 10 incontinent patients saw an improvement when treated with PTNS.~      Purpose:~      The aim of this study is to analyse and evaluate the PTNS technique in the short term as a~     treatment of anal incontinence. It is done through the means of a multi-centric prospective~     randomized study.~      Patients:~      Will be included: all patients followed for anal incontinence (either with liquid or solid~     stools) having at least one accident a month for 3months, and who are not diagnosed with~     colorectal lesions and who are without anal or rectal significant anatomic anomalies, without~     rectal prolapse, and who have failed to respond to medical treatment (such as medicine or~     perineal reeducation). The main criterium to analyze the efficiency will be the number of~     fecal incontinence episodes on a bowel diary. The investigators aim to incorporate 144~     patients, that is 72 in each group. 12 centers will take part in this study, that will last 2~     years and 3 months. They are the centers of: Bordeaux, Clermont-Ferrand, Grenoble, Lyon,~     Marseille, Nancy, Nantes, Paris, Diaconesses-Croix,Paris Rothschild, Rennes, Rouen, and~     Toulouse.~      Method:~      The PTNS consists in setting two electrodes on the posterial tibial nerve pathway. The~     electrodes are connected to an external stimulator. After having drawn lots, patients will be~     treated for 3months either with effective stimulation (frequency: 14hz; impulse duration:~     210usec;intensity:sensibility threshold), or with shame stimulation (intensity: 0mAmp). There~     will be two daily sessions of stimulation (effective, or shame), 20 min each. A pre-treatment~     assessment will be established, composed of a stool diary, a Cleveland Clinic score, a Fecal~     Incontinence Quality of Life scale and an anorectal manomety, that will all be repeated by~     the end of the treatment.~      Expected Results:~      The investigators hope to prove the short term efficacy of the PTNS on anal incontinence~     patients.~   "
197529|NCT00977587|"~     Irritable Bowel Syndrome (IBS) is a common condition characterised by abdominal pain or~     discomfort and altered bowel habit affecting up to 10% of the population. There are several~     groups of patients that are based on differing bowel patterns including IBS with diarrhea~     (IBS-D) and those with post infective IBS (PI-IBS) whose symptoms begin after an acute~     infection. Saccharomyces cerevisiae, the yeast used in bread making has been shown to reduce~     the duration of infectious diarrhoea. Part of the benefit maybe that it can destroy bacterial~     toxins. Recent studies suggest an increase in proteases (chemicals which breakdown proteins)~     in the stool of patients with IBS-D. The investigators think that this yeast may benefit~     patients with IBS-D and PI-IBS by reducing the amount of protease in stool. This is important~     because proteases have been shown to be potentially important in generating some of the~     discomfort experienced by patients. The investigators will study patients with chronic IBS-D~     who will receive 2 weeks treatment with the yeast or placebo followed by a 4 week gap and~     then a further 2 week treatment with placebo or the yeast, with the treatments allocated~     randomly. The investigators will also study 30 subjects who still have persistent loose bowel~     function 6 weeks after an infection with Campylobacter jejuni, one of the commonest causes of~     gastroenteritis in the UK. Subjects will be randomised to take either the yeast or placebo~     for 4 weeks . In both studies, the investigators will examine the effect of treatment on~     stool proteases, stool frequency and consistency and abdominal discomfort; the investigators~     will also take blood samples to examine some aspects of immune system function. The results~     of the study may suggest how yeast provides a benefit in patients with IBS and diarrhea and~     will provide data for a larger clinical trial.~   "
197530|NCT00977574|"~     This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or~     paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see~     how well they work in treating patients with stage III, stage IV, or recurrent endometrial~     cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ixabepilone, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the~     ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. It is not yet known which treatment~     regimen is most effective in treating patients with endometrial cancer.~   "
197531|NCT00977561|"~     This study will summarize the safety of patients receiving figitumumab combined with~     etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or~     carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung~     Cancer.~   "
197532|NCT00977548|"~     The purpose of this research study is to find out what effects, good and/or bad, erlotinib~     has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the~     Food and Drug Administration (FDA) to treat non-small cell lung cancer; however, erlotinib~     use in this study is considered investigational as the FDA has not approved it for the~     treatment of myelodysplastic syndrome.~   "
197533|NCT00977522|"~     This study is examining the efficacy of PF-03463275 compared to placebo in treating negative~     symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients~     with schizophrenia.~   "
197534|NCT00977509|"~     To compare the frequency of individual genetic abnormality between tumor cells and blood~     specimens.~   "
197535|NCT00977496|"~     The goal of this study is characterize the changes in bacterial diversity of the nares of~     hemodialysis patients. Another goal is to determine when hemodialysis patients become~     colonized with the bacteria Staphylococcus aureus, as nasal colonization with S. aureus is a~     major risk factor for invasive infection in hemodialysis patients. Fifteen subjects will be~     recruited into the study. Nasal swabs will be collected every month for six months or until~     one month after S. aureus colonization in order to determine any changes in the bacterial~     communities of the nose. Clinical data will also be collected to evaluate the possible~     influence of external factors on changes in the microbial communities in the patients' noses.~     This study will provide preliminary data on whether oral- and/or nasal-administered~     probiotics can eliminate nasal carriage of S. aureus.~   "
197536|NCT00977483|"~     To assess clinical efficacy and safety of long-term orally administered thioctic acid in the~     treatment of diabetic polyneuropathy.~   "
197537|NCT00977470|"~     The purpose of this research study is to learn if adding hydroxychloroquine (HCQ) to~     erlotinib helps treat non-small cell lung cancer (NSCLC). Another goal of this research study~     is to learn more about NSCLC and how it may respond to study treatment. Erlotinib (Tarceva)~     is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block a protein called the~     epidermal growth factor receptor (EGFR). EGFR may control tumor growth and tumor cell~     survival. However, although TKI drugs can work for some lung cancer patients for a period of~     time, eventually the tumor finds a way to resist or counteract the TKI treatment and it~     begins to grow again. Hydroxychloroquine (HCQ) is a drug approved by the FDA for treating~     malaria, rheumatoid arthritis, and several other diseases. Laboratory research suggests that~     when HCQ is given with a TKI, it may help delay or prevent TKI resistance from developing.~   "
197538|NCT00977457|"~     This trial studies the side effects and best way to perform genetic testing in predicting~     biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and~     storing samples of tissue, blood, and other body fluids from patients to test in the~     laboratory and collecting information about the patient's health and treatment may help~     doctors learn more about cancer and help predict the recurrence of prostate cancer~   "
197539|NCT00977444|"~     Abstract~      Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This~     study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of~     knee.~      A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried~     out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly~     injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8~     mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will~     be the change from baseline to final assessment in the Western Ontario and McMaster~     University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.~   "
197540|NCT00977431|"~     This study is a phase I, open label trial to determine the Maximum Tolerated Dose (MTD),~     safety, pharmacokinetics, and efficacy of BIBW 2992 (an epidermal growth factor~     receptor(EGFR)inhibitor) to be used in combination with:~        -  radiotherapy alone (in patients with an unmethylated (functioning) MGMT gene regulator)~          or~        -  radiotherapy and Temozolomide (in patients with a methylated (silenced) MGMT gene) to~          treat newly diagnosed patients with Grade IV Glioblastoma (primary brain cancer).~   "
197615|NCT00976456|"~     Multi-center, open, randomized (parallel) and comparative phase III.~      Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed~     by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.~      Arm A: Bevacizumab + pemetrexed~      Arm B: Bevacizumab + pemetrexed + carboplatin~   "
197541|NCT00977418|"~     Seniors 65 years of age and older represent one of the fastest growing segments of society~     with the population doubling within the next 25 years with dramatic rates of mental decline,~     costing society billions of dollars each year. The proposed research seeks to discover~     whether relatively short term mental or physical training can enhance gist reasoning,~     generalize to untrained cognitive areas and modify/strengthen brain function in areas~     susceptible to aging processes. To identify neuroprotective and non-pharmacological~     interventions to prevent mental decline and maximize cognitive brain health during the course~     of the adult lifespan has major public policy implications.~   "
197542|NCT00977405|"~     The investigators' hypothesis is that placement of CollatampG in the subcutaneous layer of~     contaminated abdominal wounds is effective prophylaxis for superficial surgical site~     infection (SSI). CollatampG is composed of highly purified type 1 collagen obtained from~     bovine tendon, which acts as a vehicle for the aminoglycoside antibiotic, gentamicin. This~     implant provides a high concentration of local gentamicin at the surgical wound to decrease~     the local microorganism load. It has been shown that if a surgical site is contaminated with~     > 10 to the power of 5 microorganisms per gram of tissue, the risk of infection is markedly~     increased. When a gastrointestinal organ is the source of pathogens, gram-negative bacilli~     (e.g., E. coli) are typical isolates, which are susceptible to gentamicin. Therefore, a high~     local concentration of gentamicin at the contaminated surgical wound provided by the~     CollatampG implant may prevent the local bacterial load from reaching levels high enough to~     cause a clinical infection.~   "
197543|NCT00977392|"~     RATIONALE: Women who do not undergo routine cervical screening may be more likely to collect~     a self-sample for human papillomavirus testing.~      PURPOSE: This randomized clinical trial is studying self-sampling in women who do not undergo~     routine cervical screening.~   "
197544|NCT00977379|"~     This open-label, randomized, parallel arm study will evaluate the effect of capecitabine~     administered concurrently with WBRT and as maintenance therapy in participants with breast~     cancer and newly diagnosed brain metastases. Participants will be randomized to receive~     either capecitabine with 10 days standard WBRT, or WBRT alone. Maintenance therapy will~     follow with capecitabine or another systemic therapy in the WBRT only group.~   "
197545|NCT00977366|"~     Central sensitisation is an increase in the excitability of nerves within the central nervous~     system, which can lead to heightened sensitivity to certain stimuli. This process is involved~     in some chronic pain conditions e.g. migraines and non−cardiac chest pain. Recent work by our~     group suggests central sensitisation may be an important mechanism leading to chronic cough.~      The main questions in this study include:~        1. Can the investigators induce temporary central sensitisation of the cough reflex in~          healthy volunteers for testing of new medications?~        2. Can the investigators demonstrate exaggerated sensitisation in patients with chronic~          cough (indicating these patients are already centrally sensitised)?~      In animal studies, acid infusion into the gullet (oesophagus) is able to induce central~     sensitisation of the cough reflex. Acid infusion into the oesophagus has also been shown to~     induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain~     on the front of the chest but this study did not test the the cough reflex. Using human~     participants, the investigators plan to test whether acid infusion into the oesophagus~     increases the sensitivity of the cough reflex in healthy volunteers and also patients~     complaining of chronic cough.~   "
197546|NCT00977353|"~     Major depressive disorder is a complex disease and most currently available antidepressants~     aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects.~     N-methyl-D-aspartate (NMDA), one subtype of glutamate receptors, plays an important role in~     learning and memory. N-methyl-D-aspartic acid (NMDA) enhancing agents, such as sarcosine~     (N-methylglycine), have been used as adjunctive therapy of schizophrenia. Sarcosine improved~     not only psychotic but also depressive symptoms in patients with schizophrenia. To confirm~     its antidepressant effect, the purpose of this study is to compare citalopram and sarcosine~     in efficacy for major depressive patients.~   "
197547|NCT00977340|"~     The purpose of this study is to determine whether a change in the content of nightmares is~     necessary at all in the treatment of chronic nightmares or if a single confrontation with~     their content is sufficient to reduce nightmare frequency significantly.~   "
197548|NCT00977327|"~     Purpose:~        -  Improvement of extent of resection by the use of intraoperatively acquired image data~          sets to navigate.~        -  Better define the role of different intra-operative imaging modalities, used to update~          the navigational data set, in aiding the surgeon during resection of intra-axial brain~          lesions.~        -  To examine the cost-effectiveness of different intraoperative navigational systems as a~          function of operative time and Operative time (Surgery including imaging)~      There is increasing neuro-oncological evidence that extent of resection might have an impact~     in particular in low-grade lesions.~   "
197549|NCT00977314|"~     The purpose of this study is to determine the safety and efficacy of using bone conduction~     via the teeth to treat Single-Sided Deafness (SSD).~   "
197550|NCT00977301|"~     The effect of fosamprenavir/ritonavir (steady state) on the pharmacokinetics of a single dose~     of olanzapine will be studied.~      In this study, the investigators expect an inducible effect of fosamprenavir/ritonavir on the~     CYP1A2 and UGT metabolism of olanzapine.~   "
197551|NCT00977288|"~     This study will investigate the effect of MK0859 when administered alone and when in~     combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in~     Japanese patients with dyslipidemia.~   "
197552|NCT00977275|"~     The purpose of this study is to evaluate radiation therapy directed to a small region of the~     breast in women who were recently diagnosed with early stage invasive breast cancer.~   "
197553|NCT00977262|"~     The main objective is to elucidate the acute effects of an oral intake of either saturated,~     monounsaturated or polyunsaturated fatty acids on peripheral blood mononuclear cells (PBMC)~     whole genome expression of obese and type 2 diabetic obese subjects.~   "
197554|NCT00977249|"~     Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?~      Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal~     dreams.~   "
197555|NCT00977236|"~     The purpose of this study is to evaluate and compare the eyeball elongation in high myopic~     children using partial correction orthokeratology and single-vision spectacles.~   "
197556|NCT00977223|"~     Data from the literature and previous in vitro research conducted in the investigators'~     laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid~     secretion might be controlled by sympathetic nervous system. This neurocrine regulation of~     corticosteroid secretion involves locally released neuropeptides. Among them, substance P is~     able to stimulate aldosterone and cortisol production via NK1 receptors.~      The aim of the present study is to investigate the effects of a NK1 receptor antagonist,~     aprepitant, on adrenocortical secretions in healthy volunteers. Aprepitant is a drug already~     available for the treatment of nausea induced by chemotherapy.~      In the present phase IV trial, plasma aldosterone and cortisol levels will be measured under~     treatment with aprepitant versus placebo, in both basal conditions and after activation of~     the adrenocortical function by various stimuli, including upright posture, metoclopramide,~     and insulin-induced hypoglycaemia. All healthy volunteers will be given the two substances~     (aprepitant and placebo) in a random order during two one-week periods separated by a 14~     day-wash-out.~      This study should allow to determine the role of substance P in the control of corticosteroid~     production in normal man.~   "
197557|NCT00977210|"~     The purpose of this study is to establish the Maximum Tolerated Dose (MTD) of OXi4503 given~     by weekly infusions to patients with advanced solid tumors.~   "
197558|NCT00977197|"~     This study is being done to see if Lyrica helps people with irritable bowel syndrome.~   "
197559|NCT00977184|"~     Background:~        -  In transcranial magnetic stimulation (TMS), a device creates a short-lasting magnetic~          field which induces an electric current in the brain leading to a change in the activity~          of brain cells. There are different effects on the brain with different rates of~          stimulation. In a previous study in people with Parkinson's disease, repetitive TMS~          (rTMS) given at a particular rate temporarily improved their ability to walk. A faster~          rate of rTMS may be more effective in treating symptoms than the rate originally used.~        -  This study will compare active rTMS to inactive (sham or Placebo) rTMS. Half of the~          people in this study will have active rTMS; the other half will have no brain~          stimulation with rTMS.~      Objectives:~      - To see if a faster rate of transcranial magnetic stimulation is a more effective treatment~     for the symptoms of Parkinson's disease than the slower rates that have been studied.~      Eligibility:~        -  Individuals between 40 and 80 years of age who have been diagnosed with mild or moderate~          Parkinson's disease.~        -  Participants must currently be taking Sinemet or dopamine agonists drugs (e.g.,~          bromocriptine, cabergoline, pergolide, pramipexole, ropinirole, apomorophine, and~          rotigotine), and are willing to continue their same treatments for the duration of the~          study.~      Design:~        -  This study requires 11 outpatient visits to the NIH Clinical Center over 6 weeks.~          Participants can also be admitted and stay as an inpatient in the NIH Clinical Center~          for the entire study period (for the 10 visits during the first weeks and the follow-up~          visit a month later).~        -  Initial visit will consist of a physical examination; a test of participants' time to~          walk 10 meters; and questions about memory, mood, and quality of life. Participants~          should not take Parkinson's disease medications for 12 hours before this visit; once the~          examinations and tests are complete, participants will be able to take the medications.~          Researchers will repeat the tests 1 hour after participants take the medication.~        -  TMS sessions: 8 TMS sessions (4 sessions per week) over 2 weeks. Each stimulation~          session will last half an hour. Half of the participants will receive active TMS; the~          other half will receive sham TMS.~        -  The first 10 participants will have additional tests to study the safety of rapid TMS in~          patients with Parkinson's disease.~        -  A day after completing the last TMS session, participants will repeat the same tests as~          the first visit before and after taking their medication as in the first assessment and~          respond to questions about mood, memory, and quality of life.~        -  One month after completing the last TMS session, participants will repeat the same tests~          as the first visit before and after taking their medication.~   "
197560|NCT00977171|"~     A subset of patients suffering from chronic fatigue syndrome exhibit symptoms of neurally~     mediated hypotension. While the underlying pathophysiology of chronic fatigue syndrome is not~     precisely understood, a dysfunction of the autonomic nervous system is thought to play a role~     in this subset of patients. In several small studies, subjects within this subset have noted~     improvement in their chronic fatigue symptoms when treated for their neurally mediated~     hypotension. As droxidopa acts on the autonomic nervous system and has been shown to~     ameliorate symptoms of neurally mediated hypotension, it is hypothesized that droxidopa could~     aid in the treatment of chronic fatigue symptoms.~      Neurally mediated hypotension has been associated with patients suffering from chronic~     fatigue syndrome. Droxidopa meanwhile has been approved in Japan for the treatment of the~     symptoms of neurogenic orthostatic hypotension. As such, it is hypothesized that regulating~     the autonomic nervous system in patients with Chronic fatigue syndrome may prove to be~     clinically beneficial.~   "
197561|NCT00977158|"~     The goal of this study is characterize the changes in bacterial diversity of the upper~     respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF~     patients become colonized with pathogenic bacteria that are responsible for the lethal lung~     damage in children with CF. Ten subjects will be recruited into the study. Throat swabs will~     be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order~     to chart any changes in the bacterial populations of the respiratory tract. Clinical data~     will also be collected to evaluate the possible influence of external factors on changes in~     the microbial communities. This study will provide preliminary data on whether probiotics can~     eradicate the colonization of the respiratory tract by pathogenic bacteria.~   "
197562|NCT00977145|"~     The goals of this study are to evaluate 1) the safety of administration of intratumoral~     interferon gamma with a peptide-based vaccine, in patients with melanoma and 2) the~     biological effects of the vaccine. These include an examination of changes within the tumor~     following vaccination and the evaluation of T cell responses to the vaccine both in the blood~     and at the sight of tumor.~   "
197563|NCT00977132|"~     As part of a palliative therapy concept, feasibility, toxicity, and effectiveness of~     treatment with the combination of Valproic acid and lenalidomide in Myelodysplastic Syndrome~     patients with a favorable risk profile will be investigated.~   "
197564|NCT00977119|"~     The purpose of this study is to identify possible genetic polymorphisms that contribute to~     specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and~     neutropenia).~      Additionally, this study will look at gene polymorphisms in patients experiencing the~     toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.~   "
197565|NCT00977106|"~     This study will assess the onset and maintenance of effect of tocilizumab on relief in~     patients with active moderate or severe rheumatoid arthritis who have had an inadequate~     response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will~     be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4~     weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every~     4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target~     sample size is >100.~   "
197658|NCT00975897|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors select the best treatment for patients and predict their~     response to treatment.~      PURPOSE: This randomized phase II/III trial is studying how well tumor tissue testing works~     in selecting treatment for patients with metastatic or locally advanced colorectal cancer.~   "
197566|NCT00977093|"~     The purpose of this study is to determine how well perfusion cardiac magnetic resonance (MR)~     imaging is able to detect certain heart abnormalities, such as a coronary artery narrowing.~      To this purpose, a conventional MR contrast medium (Gd-DTPA-BMA) will be used during an~     adenosine infusion (an approved substance which enlarges the arteries of the heart, so that~     the blood flow to the heart muscle increases). This magnetic resonance imaging technique will~     be compared with single photon emission computed tomography (SPECT), a well-established~     technique to detect this heart abnormalities.~      Both, cardiac MR and SPECT will be compared with invasive coronary angiography, a technique~     which directly visualized the heart vessels and narrowings of these (=standard of reference).~   "
197567|NCT00977080|"~     Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin~     D.~   "
197568|NCT00977067|"~     The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be~     determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.~   "
197569|NCT00977054|"~     Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma~     (HCC) and liver transplantation, affects approximately 170 million individuals worldwide. The~     prevention of HCV transmission and early intervention of HCV infection are urgently needed to~     reduce or halt the liver-related morbidity and mortality. Double filtration plasmapheresis~     (DFPP) has been with widespread use in clinical practice for several indications with plasma~     filters optimized for the respective elimination targets with excellent safety. By way of the~     plasma separator, the blood is separated into plasma and cell components. Separated plasma is~     then led into the plasma component separator where the pores of the plasma component~     separator further fractionate the plasma into large and small molecular components. The large~     molecular components, including pathogenic substances, is removed and discarded and the small~     molecular components, including proteins such as albumin and gamma-globulin, are returned to~     the patient and mixed with the cell components. After the initiation of pegylated interferon~     plus ribavirin (Peg-IFN+RBV) therapy, the rapid first phase relates to a significant~     reduction in virus production and the degradation of free virus particles, which is followed~     by a second much slower one reflecting the elimination and clearance of infected cells. In~     HCV patients, high baseline viral load at the initiation of therapy is considered to be a~     negative predictor for systemic vascular resistance (SVR) for HCV genotype 1 patients.~     Reduction of baseline viral load by means of therapeutic double filtration plasmapheresis~     (DFPP) may represent a plausible adjunct for improved antiviral therapy to reduce the virus~     load with the initiation of treatment in synergy with Peg-IFN and RBV combination therapy.~     Recently, several clinical studies in evaluating the therapeutic efficacy and safety of DFPP~     in conjunction with IFN-based therapy were conducted for treatment-naïve genotype 1 high~     viral load CHC patients, and CHC patients who underwent liver transplantation. These studies~     showed that patients with DFPP treatment had more favorable HCV early viral kinetics to those~     without DFPP treatment. Furthermore, all these studies showed excellent safety after DFPP~     treatment. Therefore, the investigators aimed to conduct a large-scaled randomized controlled~     trial to evaluate the overall response of DFPP for HCV genotype 1 patients with high viral~     load.~   "
197570|NCT00977041|"~     A number of studies suggest that training to increase different types of brain waves is~     related to pain relief. The purpose of the second phase of this study is to see if~     neurofeedback training might help people with chronic pain control their pain better. The~     information from the study may help the investigators treat chronic pain better in the~     future.~   "
197571|NCT00977028|"~     This pharmacokinetic clinical trial is a dose ranging study of lidocaine in tumescent local~     anesthesia. The goal is to understand the absorption pharmacokinetic of tumescent lidocaine~     and to determine an objective (statistical) estimate of the maximum safe mg/kg dosage of~     lidocaine in tumescent local anesthesia without liposuction.~   "
197572|NCT00977015|"~     The purpose of this study is to investigate the time course of PF-04764793 concentration in~     the blood following dosing by oral inhalation from dry powder inhalers.~   "
197573|NCT00977002|"~     Child extubation failure range from 4.1% to 19%. Studies in adults and children showed that~     extubation failure increases mortality mainly in those who need reintubation as this is a~     invasive procedure associated with many complications. Therefore, patients are reintubated~     when they worsen, which can contribute to organ dysfunction and increased mortality.~      Positive Pressure Noninvasive ventilation (PPNIV) has been proposed as a way to treat acute~     respiratory distress, avoiding complications of intubation and invasive ventilation. Most of~     the studies in adults are not conclusive on the benefits of PPNIV as a way to treat~     post-extubation acute respiratory distress. However, studies that evaluated the early use of~     PPNIV in post-extubation period as a way to prevent respiratory failure tend to show some~     advantages as decrease of reintubation, decrease number of respiratory distress, decrease of~     hospital infection frequency and lower mortality rate in the intensive care unit (ICU) for~     those who use PPNIV.~      In a prospective study on the use of PPNIV in 114 children, Essouri at al avoided invasive~     ventilation in 77%, being the group in patients with post-extubation respiratory distress.~      As far as the investigators know there is not any randomized, controlled study in children~     examining the PPNIV as a way to prevent post-extubation respiratory distress. The~     investigators' hypothesis is that PPNIV decreases the extubation failure rate and, as a~     consequence, the Pediatric Intensive Care Unit (PICU) and hospital length of stay, and~     mortality rate.~      The objective is to compare PPNIV and inhalatory O2 (catheter or facial mask) in children~     after extubation, evaluating the need of reintubation, hospital and PICU mortality rate and~     length of stay in PICU and hospital.~   "
197574|NCT00976989|"~     This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment~     regimens in participants with locally advanced, inflammatory or early stage human epidermal~     growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be~     randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with~     5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6,~     or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles~     4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab~     will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly,~     trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m^2~     iv, increased to 100 mg/m^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard~     doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a~     total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on~     study treatment is 4-12 months, and target sample size is 200-300.~   "
197629|NCT00976274|"~     Five factor consisting of Metabolic syndrome is closely linked by insulin resistance. Until~     now, several studies have been performed about effects of Korea red ginseng on hypertension,~     diabetes, and hyperlipidemia, but not metabolic syndrome.~      The investigators hypothesize that Korean red ginseng could improve each constituents of~     metabolic syndrome, arterial stiffness, and inflammatory markers.~      The aim of this study is to determine effects of Korean red ginseng on cardiovascular risks~     in subjects with metabolic syndrome.~   "
197659|NCT00975884|"~     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     investigational vaccine GSK2340272A.~   "
197575|NCT00976976|"~     Despite the improvement of surgical resection as primary curative treatment for gastric~     cancer, more than 70% of patients with stage IIIB and IV disease undergoing radical primary~     tumor resection relapse and die within 5 years. Therefore, there is an urgent need to further~     improve the treatment for gastric cancer in this population. Recently reported phase III~     study comparing capecitabine/cisplatin (XP) versus 5-FU/cisplatin (FP), XP showed better~     activity and tolerability compared with FP. To improve treatment outcomes of XP chemotherapy,~     the investigators performed a phase I-II study of docetaxel, capecitabine and cisplatin in~     advanced gastric cancer (AGC). Phase I-II study of docetaxel, capecitabine and cisplatin as~     first-line chemotherapy in advanced gastric cancer (Kang et al, Proc Am Soc Clin Oncol~     22,328.2003). The docetaxel/capecitabine/cisplatin (DXP) chemotherapy was highly active for~     the 1st-line chemotherapy of AGC. These findings and experience encourages the investigators~     to design the adjuvant trial of DXP chemotherapy in patients with resected gastric cancer.~     The aim of this study is to assess the efficacy and safety of adjuvant DXP in this patient~     population.~   "
197576|NCT00976963|"~     Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting~     approximately one-half of women by their late 20's. One of the most common antibiotics used~     to treat UTIs is Trimethoprim-sulfa (TMP-SMX), usually for total of three days. However,~     concerns about increased antibiotic resistance have led to increased interest in studying~     other antibiotics for UTI.~      An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin~     (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not~     well studied. The purpose of this research study is to determine what the cure rates are with~     a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.~   "
197577|NCT00976950|"~     The aim of this trial is to evaluate the safety and virological and immunological efficacy of~     Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed~     resistance to more than one protease inhibitor.~   "
197578|NCT00976937|"~     The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in~     comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index~     [BMI] greater than or equal to 30 kilogram per square meter [kg/m^2]) type 2 diabetic~     patients less than 50 years of age, over a period of 24 weeks of treatment.~      The primary objective of this study is to assess the efficacy of lixisenatide, in comparison~     to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic~     control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24.~      Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin,~     as an add-on treatment to metformin on absolute changes in HbA1c values and body weight;~     fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin~     during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model~     assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model~     assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and~     anti-lixisenatide antibody development.~   "
197579|NCT00976924|"~     Blood glucose test strips are tested with the test meters to test the accuracy of the blood~     pressure monitoring function.~   "
197580|NCT00976911|"~     This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin~     added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian,~     fallopian tube or primary peritoneal cancer with disease progression within 6 months of~     platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or~     topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive~     Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on~     study treatment is until disease progression. Patients will then receive standard of care,~     those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target~     sample size is 100-500 individuals.~   "
197581|NCT00976898|"~     In this study the investigators will be studying the effects of proton beam radiation~     therapy. This is a very accurate kind of treatment that has been shown to affect less normal~     tissue than a photon radiation beam. The accuracy allows the investigators to more safely~     increase the amount of radiation delivered to eliminate cancer. This accuracy will~     potentially reduce side effects that participants would normally experience using photon~     radiation therapy. The purpose of this study is to determine if radiation using proton beam~     therapy will kill the cancer cells in the participants liver.~   "
197582|NCT00976885|"~     The aim of this study was to measure the oxygen consumption and peak heart rate achieved~     during Modified Rivermead Mobility Index (MRMI) assessment in age-matched, healthy and stroke~     patients, and assess the efficacy of the MRMI tasks for aerobic training in patients with~     stroke.~   "
197583|NCT00976872|"~     Recent evidences showed beneficial effects of omega-3 fatty acids on cardiovascular morbidity~     and mortality.~      Regular Omega-3 fatty acid consumption reduces cardiovascular mortality, ischemic heart~     disease and stroke mortality. There is probably no single mechanism of action that explains~     this beneficial effect; but possible mechanisms include reduce susceptibility of the heart to~     ventricular arrhythmia, antithrombogenic effect, reduce triglyceride level, promotion of~     nitric oxide-induced endothelial relaxation, and retard growth of atherosclerotic plaque.~      The combination of satins and omega3 was proved to be better the any of the drugs alone in~     several studies.~      The purpose of the study is to investigate several possible mechanisms that may explain the~     add on beneficial effect of omega-3 in hypercholesterolemic patients already treated with~     satins.~   "
197584|NCT00976859|"~     The purpose of this study is to determine whether a short term programme with internet~     research on the frequency of skin exchange and guided imagery modification is effective in~     the treatment of the feeling of being contaminated in female victims of childhood sexual~     abuse (CSA).~   "
197585|NCT00976846|"~     The proposed study seeks to determine the appropriate balance between the removal of~     undesirable small molecular substances (urea, creatinine, phosphate) and large molecular~     substances (ß2-m) and the retention of important substances (e.g.albumin) for the Baxter~     Xenium XPH dialyzer type under defined therapeutic conditions of olHDF primarily concerning~     filtration flow rates in relation to blood flow/plasma water flow rates. Furthermore the~     possibility of the removal of certain protein-bound substances shall be investigated together~     with the impact of increasing ultrafiltration on the parameters of the micro-inflammation.~   "
197586|NCT00976833|"~     Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the~     4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients~     with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days,~     respectively, with median hospital costs greater than $30,000 United States. Patients with~     ARF experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and~     reduced health-related quality of life, all of which may contribute to prolonged~     hospitalization and increased costs. Mechanistically, it is understood that patients with ARF~     demonstrate acute inflammation which may contribute to the above cited problems. While the~     investigators' research and that of others has shown that rehabilitation therapy can increase~     functional outcomes while lowering biomarkers of inflammation in the frail aged and other~     clinical populations, it is not known whether such rehabilitation therapy can result in~     improved functional capacity and functional performance and reduce inflammation in ARF~     patients. There is previous evidence for the feasibility and safety of rehabilitation therapy~     in ARF patients. Therefore, the investigators propose a two-arm, randomized trial in 326~     patients with ARF to compare Standardized Rehabilitation Therapy initiated in the ICU and~     administered throughout the hospitalization versus usual care (control). Standardized~     Rehabilitation Therapy will consist of: passive range of motion, physical therapy and~     progressive resistance exercise (strength training). The regimen will be administered 7~     days/week by a Mobility Team consisting of a critical care nurse, physical therapist and~     nursing assistant.~      The investigators will determine whether standardized rehabilitation therapy will reduce~     hospital LOS, improve functional capacity and performance, improve quality of life, reduce~     inflammation and reduce hospital costs as compared to usual care.~      This study's primary objective is to determine whether standardized rehabilitation therapy~     will decrease hospital length of stay.~      Hypothesis: Compared to usual care, standardized rehabilitation therapy will reduce hospital~     length of stay for patients with Acute Respiratory Failure.~   "
197587|NCT00976820|"~     The purpose of this study is to characterize the safety and immune response of the H1N1~     (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of~     age.~      This Protocol Posting has been updated following the Protocol amendment 1 & 2, September and~     October 2009. The sections impacted are study design, objectives and analysis methods.~   "
197588|NCT00976807|"~     The principal research question to be answered by this study is whether an exercise based~     rehabilitative intervention following critical illness can generate improvements in exercise~     capacity and quality of life beyond current (usual) care. The investigators will also aim to~     demonstrate that such an intervention is both practical and cost-effective.~   "
197589|NCT00976794|"~     The purpose of this study is to determine the efficacy of the combination of lithium and~     carbamazepine compared with lithium and valproate treating young bipolar patients.~   "
197590|NCT00976781|"~     The purpose of this study is to identify the gaps in diagnosing and managing hepatitis C~     infected patients so that interventions can be targeted to address these problem areas in~     order to optimize care of these patients.~   "
197591|NCT00976768|"~     The purpose of this study is:~        -  To observe the feasibility of biweekly oxaliplatin and infusional 5-fluorouracil~          (FU)/Leucovorin (LV) in patients with advanced gastric adenocarcinoma who have prior~          exposure to taxane, fluoropyrimidine, and cisplatin~        -  To determine the activity of this combination regimen.~        -  To evaluate the treatment-related toxicities.~   "
197592|NCT00976755|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying the side effects of everolimus and to see how well~     it works as first-line therapy in treating patients with prostate cancer.~   "
197593|NCT00976742|"~     The investigators hypothesize that the degree to which older generally healthy but sedentary~     men and women improve a number of cardiovascular (CV) disease risk factors with 6 months of~     highly-standardized endurance exercise training will be a function of common genetic~     variations in candidate genes.~   "
197594|NCT00976729|"~     This is the first time NOX-E36 will be administered to man. The principal aim of this study~     is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous~     (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information,~     together with the pharmacokinetic and pharmacodynamic data, will help establish the doses,~     dosage regimen and route of administration suitable for multiple dose administration to~     healthy volunteers, followed by the studies in the patient population.~   "
197595|NCT00976716|"~     To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic~     pain for the duration of 8 days.~   "
197596|NCT00976703|"~     This study aims to determine what type of traction, weighted bag or inner thigh taping, on~     foley catheters for cervical ripening results in a greater cervical dilation and shorter~     length of labor.~      The primary outcomes are post-ripening dilation of 3 cm or more and time to delivery.~      The secondary outcomes are patient pain/comfort rating and method of delivery. The~     investigators hypothesize that the use a weighted bag will result in a 20% increase in~     post-ripening dilation of at least 3 cm and a shorter average length of labor.~   "
197597|NCT00976690|"~     To show the superiority of Azathioprine comparing Mesalazine in the prevention of~     postoperative recurrence in Crohn's Disease.~   "
197598|NCT00976677|"~     This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab work~     with or without erlotinib hydrochloride in treating non-smokers with advanced non-small cell~     lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and~     by blocking blood flow to the tumor. It is not yet known whether giving combination~     chemotherapy together with bevacizumab is more effective with or without erlotinib~     hydrochloride in treating patients with non-small cell lung cancer.~   "
197599|NCT00976664|"~     The purpose of this research study is to determine the change in perceived levels of pain and~     dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe~     orthotics for a three month period. The hypothesis of this study is that custom orthotic~     intervention will improve the patients' low back pain and dysfunction symptoms.~   "
197600|NCT00976651|"~     The purpose of the present study is to assess the influence of the administration of low dose~     hCG on the endometrium. The study is a randomised trial where 2 groups of patients,~     undergoing a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization,~     are studied. In addition to the histological findings, by analysing the correlation of the~     morphological pattern and gene expression profile of human endometrium on the day of oocyte~     retrieval in patients of both treatment groups, the investigators want to study the~     implantation potential.~   "
197601|NCT00976638|"~     Colonization of patients with Antimicrobial Resistant Bacteria (AMRB) like Methicillin~     Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and~     Extended-Spectrum Beta-Lactamases (ESBL) enterobacteriaceae leads to infections; and~     ultimately to adverse outcomes (eg prolonged hospital stay, death). This is an urgent problem~     in Europe, especially in Intensive Care Units (ICUs).~      In this trial, colonization of patients with these AMRB will be assessed in the baseline~     period (6m). In phase 2 the effect of a Hygiene Improvement Program, including Chlorhexidine~     body washings and a Hand Hygiene training program, will be assessed (6m). In phase 3 units~     will be randomized to either Active Surveillance with Chromagar based tests or a Molecular~     based tests.~      Study Hypothesis: the abovementioned interventions will reduce ICU-acquired colonization~     rates with MRSA, VRE and ESBL.~   "
197602|NCT00976625|"~     Follow-up study in patients with severe aortic regurgitation after successful valve~     replacement. Systolic and diastolic function were assessed and persistent diastolic~     dysfunction was observed late (7-10 years) after operation.~   "
197603|NCT00976612|"~     In patients who are receiving nilotinib, nilotinib plasma levels will be measured after 1~     month of nilotinib treatment. The relationship between surgery type and nilotinib~     pharmakokinetic properties will be investigated in this study.~   "
197604|NCT00976599|"~     To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid~     arthritis. To evaluate the safety, tolerability and efficacy of CP-690,550.~   "
197605|NCT00976586|"~     Incontinentia Pigmenti (IP) is an X-linked dominant ectodermal dysplastic disorder. It is due~     to loss of function of NF-Kappa B Essential Modulator (NEMO, inhibitor of Kappa light~     polypeptide gene enhancer in B cells, Kinase of Gamma, IKBKG), an important regulator of the~     NF-kB pathway. Major clinical manifestations of IP include swirling skin pigmentary changes,~     and anomalies in organs including the eyes, dental, bones, nervous system, and heart.~     Affected male mostly die before birth. Older patients might have immunodeficiency,~     psychomotor retardation, and seizures. Prenatal diagnosis is difficult. IKBKG gene is 35 kb~     in length, and contains 10 exons. A pseudogene (∆NEMO, IKBKGP), located distal and in inverse~     direction to the true gene, contains only exon 3-10. In patients with IP, the most common~     mutation was exon 4-10 large deletion. But the investigators have found small mutations~     derived from the pseudogene in Taiwanese patients.~      The three aims of this study are the role of pseudogene in IP, the frequency of recombination~     between IKBKG and IKBKGP, and possible treatment. To achieve the first aim, the investigators~     first develop a pseudogene-specific polymerase chain reaction (PCR). The investigators will~     first obtain the frequency of IKBKGP gene mutation in normal individuals. The investigators~     will then detect IKBKGP related mutations in IP patients presenting classical or~     non-classical symptoms. The latter group of patients, who may have isolated hair, teeth,~     retinal, or immune problems, are more likely to be caused by point mutations. The second aim~     of this study is to estimate the incidence of IKBKG and IKBKGP recombination. Because these~     two genes are in opposite position, recombination after DNA loop back is likely to occur in~     somatic cells. The investigators will transform lymphocytes containing IKBKGP mutation, and~     culture them continuously. IKBKG mutation will be check intermittently and the incidence can~     be estimated. The third aim is to find a treatment. The investigators will test the~     read-through drug gentamycin and PTC2124 for nonsense mutation. Either fibroblast or~     Epstein-Barr virus (EBV) - transformed lymphoblasts will be tested. The investigators hope~     this study with not only increases our understand to IP, and also improves the investigators'~     knowledge toward genetic diseases.~   "
197606|NCT00976573|"~     This randomized phase II trial is studying how well carboplatin, paclitaxel, and bevacizumab~     work when given with or without everolimus in treating patients with malignant melanoma that~     has spread from where it started to other places in the body. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab, may block the ability of tumor cells to grow and spread. Everolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking~     blood flow to the tumor. It is not yet known whether combination chemotherapy given together~     with bevacizumab is more effective with or without everolimus in treating patients with~     metastatic melanoma.~   "
197607|NCT00976560|"~     In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive~     design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be~     investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of~     GW856553 or placebo for six weeks. Safety, tolerability, pharmacokinetics and~     pharmacodynamics, defined as biomarkers in blood and clinical symptoms, will be assessed.~      The primary endpoint is the change from baseline associated with GW856553 versus placebo at~     Week 6 in the Bech (6-item HAMD-17) score. Interim analyses of the primary endpoint will be~     performed throughout the study to potentially adapt the study design by changing the~     randomization ratio and/ or reducing the total number of subjects to be randomized into the~     study. Exploratory analyses will be performed by associating changes in cytokine levels and~     selected clinical symptoms; PK/PD modelling will also be used to identify the most sensitive~     clinical and biological markers.~   "
197608|NCT00976547|"~     Objective: To evaluate the correlation between audiometric thresholds, pitch matching (PM),~     minimum masking level (MML), Tinnitus Handicap Inventory (THI) and the Beck Depression~     Inventory (BDI) in tinnitus patients.~      Subjects: 48 patients with tinnitus as the main complaint from OTOSUL, Otorrinolaringologia~     Sul-Fluminense, Volta Redonda, RJ, Brasil and Centro de Tratamento e Pesquisa em Zumbido,~     Belo Horizonte, MG, Brasil.~      Method: Subjects performed tonal audiometry, Pitch Matching (PM) and Minimum Masking Level~     (MML) for tinnitus. They also fulfilled the Tinnitus Handicap Inventory (THI) and Beck~     Depression Inventory (BDI). Data was statistically compared for correlation between~     audiometric thresholds, psycho-acoustic measures and questionnaires.~   "
197609|NCT00976534|"~     The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in~     patients with peripheral neuropathic pain. This will be done by comparing the effect of~     AZD1386 to placebo (inactive substance) on pain.~   "
197610|NCT00976521|"~     This is a multicenter, open-label, controlled, single-blind, randomized study with up to 452~     subjects enrolled in up to 50 US and European sites. Subjects who present with anterior~     ST-elevation myocardial infarction (STEMI) and an occluded proximal or mid left anterior~     descending (LAD) with TIMI 0/1/2 flow will be eligible for randomization to one of the~     following arms:~        1. Local infusion of abciximab following thrombus aspiration~        2. Local infusion of abciximab and no thrombus aspiration~        3. No local infusion and thrombus aspiration~        4. No local infusion and no thrombus aspiration~      In addition, a cardiac magnetic resonance imaging (MRI) sub-study evaluating microvascular~     obstruction (MVO) will be performed with up to 160 subjects at up to 20 sites.~   "
197611|NCT00976508|"~     This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus~     Pegvisomant for treatment of advanced solid tumors.~   "
197616|NCT00976443|"~     Obesity is an important public health problem in the United States. The investigators~     hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an~     endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation,~     and reduction in body weight. This protocol is designed to study the effects and safety of~     gastric BTA injections. Subjects are randomized to receive placebo or one of two different~     doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric~     emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric~     intake are recorded before and after injections, and subjects are seen in follow-up for 24~     weeks.~   "
197617|NCT00976430|"~     This study is intended to look at the safety and efficacy of the use of autologous bone~     marrow derived stem cell transplant in patients with advanced Parkinson's disease.~   "
197618|NCT00976417|"~     It is known that a significant proportion of patients with heart failure have sleep~     disordered breathing (SDB). Some of these patients will have Central Sleep Apnoea which is~     one form of SDB. The SERVE-HF study aims to look at the effect of a breathing support~     machine, or ventilator called Adaptive Servo-ventilation (ASV) on mortality in heart failure~     patients with central sleep apnoea. In this related sub-study the investigators want to look~     at how the ASV machine has its effect. The investigators will be carrying out tests in the~     laboratory to measure various aspects of the way that breathing is controlled to measure the~     effect that ASV has on patients.~      In addition measurements looking at activity levels will be made using an actiwatch device~     worn by patients for 14 consecutive days and nights.~      Healthy controls will be recruited to all parts of this protocol (ie measurements at baseline~     and 3 months) to allow comparison of data between patients and controls.~   "
197619|NCT00976404|"~     The objective of this study is to discover a new approach in which human immunodeficiency~     virus (HIV) can be eradicated from an infected individual by intensified antiretroviral~     treatment coupled with immunomodulation. The hypothesis is that eradication is possible only~     if very potent antiretroviral drugs are delivered in conjunction with an immunomodulatory~     agent that simultaneously attack the viral reservoirs.~   "
197620|NCT00976391|"~     This study will examine the safety and efficacy of albiglutide in combination with insulin~     glargine as compared with the combination of insulin glargine and preprandial lispro insulin~     in subjects with type 2 diabetes.~   "
197621|NCT00976378|"~     This is the first time NOX-A12 will be administered to man. The principal aim of this study~     is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous~     (IV) doses to healthy male and female subjects. This information, together with the~     pharmacokinetic and pharmacodynamic data, will help establish the doses and dosage regimen of~     administration suitable for subsequent studies in the patient population.~   "
197622|NCT00976365|"~     The purpose of this study is to obtain evidence from test article with efficacy in Metastatic~     Breast Cancer patients. The average of all changes from baseline to post-treatment~     evaluations in global health/quality of life (QoL) subscale assessed by self-administered~     European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -~     Core 30 (EORTC-QLQ-C30).~   "
197623|NCT00976352|"~     Pompe disease is an inherited condition of acid alpha-glucosidase (GAA) deficiency resulting~     in lysosomal accumulation of glycogen in all tissues. Glycogen accumulation leads to muscle~     dysfunction and profound muscle weakness. A wide spectrum of disease is characteristic and~     the most severe patients have cardiorespiratory failure, often fatal in the first two years~     of life. Researchers have developed a way to introduce the normal GAA gene into muscle cells~     with the expectation that the GAA protein will be produced at levels sufficient to reduce~     glycogen accumulation. This study will evaluate the safety of the experimental gene transfer~     procedure in individuals with GAA deficiency. The study will also determine what dose may be~     required to achieve improvement in measures of respiratory function.~   "
197624|NCT00976339|"~     This proposal is for a pilot study of 20 premenopausal women at high risk for breast cancer~     development who will receive high dose vitamin D3, cholecalciferol 20,000 IU (2 capsules)~     weekly, or 30,000 IU (3 capsules) weekly, for 1 year. The primary objective of this study is~     to determine the feasibility of a 1-year intervention of vitamin D in this study population.~     Secondary objectives include evaluating the biologic effects of vitamin D supplementation on~     blood based and image-based biomarkers.~   "
197625|NCT00976326|"~     This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the~     pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an~     extent that the dose should be adjusted in subjects with impaired liver function compared to~     the dose for subjects with normal liver function.~   "
197626|NCT00976313|"~     Under the influence of epidural analgesia, patients may not feel the urge to urinate, which~     can result in urinary retention and bladder overdistension.~      The use of a transurethral catheter is associated with significant morbidity such as patient~     discomfort, urinary tract infections, urethral trauma and stricture.~      Urodynamic changes under thoracic epidural anaesthesia are still unknown. The aim of this~     study is to compare lower urinary tract function before and during thoracic epidural~     analgesia within segments T2 to T10 for postoperative pain treatment in patients undergoing~     thoracotomy or sternotomy.~   "
197627|NCT00976300|"~     Intravenous cyclophosphamide is considered to be the standard of care for treatment of~     proliferative lupus nephritis. However, its use is limited by potentially severe toxic~     effects. Cyclosporine A has been suggested to be an efficient and safe treatment alternative~     to cyclophosphamide. In a randomized, multicenter, open-label, controlled trial the~     investigators sought to compare the efficacy of oral cyclosporine A with intravenous pulse~     cyclophosphamide to induce durable remission in patients with lupus nephritis III-IV.~   "
197628|NCT00976287|"~     The purpose of this study is to investigate the efficacy of autologous bone marrow~     mesenchymal stem cells (MSCs) transplantation via hepatic artery in the treatment of liver~     cirrhosis. Liver function was monitored by serum examination. The levels of serum alanine~     aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) and albumin (ALB) were~     examined at pre-transplantation, and 3 days to 2 years post-transplantation. Child-Pugh~     scores and clinical symptoms were also observed simultaneously.~   "
197657|NCT00975910|"~     The purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage~     on postoperative cognitive dysfunction in supratentorial craniotomy.~   "
197630|NCT00976261|"~     The purpose of Part A of this study is to test whether repeated doses of the study drug~     (GSK1614235) are safe and well tolerated (i.e. do not produce unacceptable side effects) and~     whether we can obtain some preliminary information as to whether it works in lowering blood~     glucose levels. We will do this by comparing the effect of the study drug with placebo (no~     drug present) and against a drug (sitagliptin) known to control blood glucose in the~     treatment of diabetes.~      The purpose of Part B of this study is to determine the how the timing of dosing, relative to~     meals, affects the response to study drug.~   "
197631|NCT00976248|"~     The purpose of this research study is to determine the safety of RAD001(Everolimus) and the~     highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug~     that works by preventing cells in the body from growing and dividing. Information from basic~     and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor~     growth in people with relapsed or refractory lymphoma.~   "
197632|NCT00976235|"~     This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by~     Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope~     prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to~     monitor long-term safety. Patients will undergo examinations at six-month intervals up to a~     total of 5 years following implantation.~   "
197633|NCT00976222|"~     The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with~     retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).~   "
197634|NCT00976209|"~     This is a randomized, two-way crossover, multicenter study evaluating the consumer preference~     of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or~     Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every 4 hours in~     subjects with at least mild allergic rhinitis and nasal congestion. Approximately 250~     participants will complete a questionnaire after taking one test product for 3 days followed~     by a 3 day (± 1 day) washout period; and then taking the alternate test product for 3 days.~     Analysis of which product the consumer preferred, if any, and which product was more~     convenient, if any, will be evaluated.~   "
197635|NCT00976196|"~     The PHP study aims to delineate gene products involved in high on-treatment platelet~     reactivity in aspirin-treated cardiovascular patients.~   "
197636|NCT00976183|"~     Since the mortality rates for patients with advanced ovarian carinoma are high, the most~     likely way to improve progression free and overall survival is with maximal upfront therapy~     (Morrow & Curtin, 1998). Currently, no triplet regimen has demonstrated compelling~     superiority. Therefore, the combination of Paclitaxel, Carboplatin, and Vorinostat is~     intriguing because of their potential synergy, distinct mechanisms of action, and~     non-overlapping toxicity.~   "
197637|NCT00976170|"~     This phase I trial is studying the safety and best dose of GC33 and Sorafenib in combination~     in patients with advanced or metastatic liver cancer.~   "
197638|NCT00976157|"~     Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that~     plays an important role in myeloid cell-activated inflammatory responses. The aim of this~     study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in~     bronchoalveolar lavage (BAL) fluid of clinically diagnosed ventilator-associated pneumonia~     (VAP) and its correlation with response to treatment and outcome.~   "
197639|NCT00976144|"~     GW642444 is a potent and selective long-acting beta2 agonist; GSK573719 is a long-acting,~     inhaled, muscarinic receptor antagonist (or anticholinergic) bronchodilator. Both are in~     development as once daily (QD) monotherapies for the treatment of Chronic Obstructive~     Pulmonary Disease (COPD). Development of these two inhaled drugs as a combination therapy is~     also planned and would have potential for improved efficacy and patient benefit as they both~     work through different receptor pathways and the combined bronchodilatory effect might be~     additive.~      This study is a randomised, double blind, placebo-controlled, four-way crossover study which~     will assess the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of~     GSK573719 and GW642444 in sixteen healthy Japanese subjects. Subjects will receive four~     possible treatments as single inhaled doses, receiving the two monotherapies separately, the~     monotherapies concurrently, and placebo.~      Blood samples for PK analysis will be taken at regular intervals after dosing. Safety will be~     assessed by measurement of heart rate, blood pressure, ECG and twenty-four hour Holter~     monitoring, potassium, safety laboratory data and review of adverse events.~   "
197640|NCT00976131|"~     This research study hopes to examine the effects of Coenzyme Q10 on doxorubicin (Adriamycin)~     metabolism during breast cancer treatment.~   "
197641|NCT00976118|"~     This phase 2 study was designed to evaluate the activity of oral masitinib (AB1010)~     administered at 2 dose levels during 24 weeks to patients with mild to moderate confirmed~     Alzheimer's type disease.~   "
197642|NCT00976105|"~     The overall purpose of this study is to see whether the drug is safe and well tolerated when~     given to overweight or obese but otherwise healthy volunteers for 10 days. Up to 4 groups of~     people will be given the drug at variable strengths. The blood levels of the drug will be~     measured and the effects on mood and cognition (the mental processes involved in awareness,~     learning and judgement) will be assesed.~   "
197643|NCT00976092|"~     Randomized comparison of two different anticoagulation strategies: prasugrel plus bivalirudin~     versus clopidogrel plus heparin in patients with acute myocardial infarction undergoing~     emergency catheterization and coronary intervention.~   "
197644|NCT00976079|"~     Participants diagnosed with tibial femoral knee osteoarthritis will be assigned to one of~     three treatment groups including: active transcutaneous electrical nerve stimulation (TENS),~     placebo TENS, and a control group. Assignment of conditions will be concealed. All~     participants in each of the three groups will receive physical therapy for all 4 weeks of the~     intervention. Main outcome measures will include quadriceps central activation ratio,~     quadriceps torque production, WOMAC scores, visual analog pain scores during gait as well as~     knee joint kinetics and kinematics during gait. The purpose of this study is to to determine~     if the continuous use of TENS therapy for activities of daily living and rehabilitation will~     positively impact all outcome measures.~   "
197645|NCT00976066|"~     The purpose of this study is to determine whether GSK1521498 attaches to sites in the brain~     called mu-opioid receptors that are involved in the liking reactions to palatable high fat~     and high sugar foods. We hope that blocking these receptors may modify certain behaviours~     that may lead to obesity.~   "
197646|NCT00976053|"~     The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with~     pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head~     comparison in the same patient. The investigators hypothesize that pharmacologic stress~     myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion~     SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery~     disease (CAD) who present with symptoms consistent with possible worsening of their CAD.~   "
197647|NCT00976040|"~     The goal of this randomized clinical trial is to compare early versus standard timing of~     initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus~     neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal~     Meningitis.~      The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans~     from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units~     (CFUs) during the first 28 days after initiating antifungal treatment.~      Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C.~     neoformans, as manifested by increases in the number and function of C. neoformans-specific~     peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In~     addition, patients randomized to the intervention arm will have more rapid clearance of~     antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse~     events.~   "
197648|NCT00976027|"~     The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of~     Fluzone® vaccine in the elderly.~      Primary objective:~      To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed~     influenza caused by viral types/subtypes that are antigenically similar to those contained in~     the respective annual vaccine formulations.~      Secondary objectives:~        -  To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone®~          vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused~          by any type or subtype of influenza virus.~        -  To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone®~          vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by~          viral types/subtypes antigenically similar to those contained in the respective annual~          vaccine formulations.~   "
197649|NCT00976014|"~     This observational study looks at Carotid Stenosis in two groups of subjects using a~     non-invasive procedure, B-mode ultrasound.~      One group of subjects has had long-term intensive lipid altering therapy (lowering LDL-C plus~     raising HDL-C). The second group of patients has been on conventional standard of care~     treatment for carotid stenosis.~      The study will look at the Carotid Intima-media Thickness (CMIT) in both groups.~      Hypothesis: CIMT will differ between the two groups, such that the CIMT will be less in the~     subjects on intensive lipid altering therapy.~   "
197650|NCT00976001|"~     This is a randomized follow-up study after discharge from a stroke unit after a first stroke.~     The patients are randomized either to follow-up at a special out-patient stroke unit or with~     their general practitioners. The hypothesis is that follow-up with specialists is superior to~     follow-up with general practitioners. Endpoints are mortality, recurrent stroke and handicap~     measured with different scales.~   "
197651|NCT00975988|"~     Non-interventional, open-label, single group, multicentric post-marketing surveillance to~     monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients~     according to the prescribing information TYKERB® is a registered trademark of the~     GlaxoSmithKline group of companies.~   "
197652|NCT00975975|"~     The purpose of this study is to compare the effects (good and bad) of the medication~     basiliximab in combination with cyclosporine (investigational therapy) for the prevention of~     a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD~     is a complication in which the cells of the transplanted bone marrow react against organs and~     tissues.~   "
197653|NCT00975962|"~     This study is a blinded randomized study. Randomization for treatment/not treatment with~     remote perconditioning takes place during transportation to the hospital. This is because the~     investigators' hypothesis states that remote perconditioning is neuro-protective and the~     effect is proportionally larger with early treatment. As the size of the effect is unknown,~     the investigators will use multiple magnetic resonance imaging (MRI) scans to determine the~     size of a potential neuro-protective effect.~      The aims of this study are:~        1. To describe method of remote perconditioning in clinical practice regarding feasibility.~          Pros and cons and potential limitations.~        2. To estimate the size of the effect of remote perconditioning in combination with~          recombinant tissue plasminogen activator (rtPa) treatment within four and a half hours~          of onset of symptoms.~   "
197654|NCT00975949|"~     The purpose of this study is to compare the neurodevelopmental outcome and quality of life~     between the fluconazole-treated and the placebo-treated patients that were enrolled in a~     fluconazole prophylaxis study that occurred in the investigators' neonatal intensive care~     unit (NICU) between 1998-2000.~   "
197655|NCT00975936|"~     This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction~     (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well~     as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in~     healthy adult subjects. This will be an open-label fixed-sequence 2-period study in healthy~     male volunteers after oral administration of [14C]-GSK706769 alone and in the presence of~     Ketoconazole.~   "
197656|NCT00975923|"~     One group of hospitals participated in a collaborative approach for healthcare quality~     improvement while another group was provided only a tool kit. The investigators' objective~     was to determine if the Collaborative would perform better at preventing central~     line-associated bloodstream infections (CLABSI) and ventilator-associated pneumonias (VAP).~     Hospitals were randomized to the Tool Kit or Collaborative conditions. The investigators'~     study evaluated the effects on care processes and outcomes of a multi-institutional quality~     improvement initiative focused on preventing hospital associate infections. The~     investigators' hypothesis was that the strategies for implementing safe critical care~     practice will differ in level of achievement whereby the Collaborative group will perform~     better than the Tool Kit group. The outcome measure comprised clinical event rates and an~     index of safe practices that represent a bundling of key process measures related to~     evidence-based practices for preventing catheter-related blood-stream infections and~     ventilator-associated pneumonia in the intensive care unit.~   "
197660|NCT00975871|"~     Livedo vasculitis is disease with recurrent courses of painful foot or ankle ulcerations,~     followed by healed white scars. The actual mechanism of its pathophysiology is not yet clear.~     It has been reported to be associated with some gene mutations, for example, factor V Leiden~     gene. This study is aimed to find the possible relation of these gene mutations in Taiwanese~     patients.~   "
197661|NCT00975858|"~     The randomized comparison of two strategies in coronary revascularization: bypass surgery~     without the use of a heart lung machine and coronary stenting procedure.~      The comparison comprised the occurrence of cardiac adverse events after the procedure. In~     addition, costs, cognitive outcomes and angiography were assessed.~   "
197662|NCT00975845|"~     To compare the outcome of Anterior Cruciate Ligament (ACL) reconstruction performed using the~     tibialis allograft to historical outcomes of ACL reconstruction patients and to establish if~     any correlation exists between the age of the graft donor and the clinical outcomes.~   "
197663|NCT00975832|"~     Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this~     study, the investigators investigated the expression of different mediators of inflammation~     in fatty tissue and in blood in women with and without PCOS.~   "
197664|NCT00975819|"~     The purpose of this study is to determine if the use of sirolimus in the treatment of~     children and young adults with complicated vascular anomalies will prove to be safe and~     provide objective response resulting in improved clinical status and quality of life.~      Funding Source - FDA OOPD (Food and Drug Administration - Office of Orphan Products~     Development)~   "
197665|NCT00975806|"~     The purpose of this study was to determine the maximum tolerated dose, safety, and~     effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as~     treatment for patients with renal cell carcinoma.~   "
197666|NCT00975793|"~     The ARISE RCT is a multi-centre, randomised, controlled trial of EGDT compared to standard~     care in patients with severe sepsis presenting to the ED. The study will be conducted in~     multiple sites with 1600 patients enrolled into the study.~      Hypothesis to be tested: EGDT, compared to standard Australasian resuscitation practice,~     reduces 90-day all-cause mortality in patients presenting to the ED with severe sepsis.~   "
197667|NCT00975780|"~     The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol~     in preventing pneumonia among nursing home residents.~   "
197668|NCT00975767|"~     The main purpose of this study is to assess the safety profile of MGCD265 when administered~     in combination with the marketed anticancer drugs erlotinib and docetaxel.~   "
197669|NCT00975754|"~     The purpose of this study is to assess the deposition of budesonide to the lung after~     inhalation with 5 different devices and to relate the findings to in vitro properties of~     inhaled budesonide.~   "
197670|NCT00975741|"~     Mometasone furoate (MF) is a new potent synthetic corticosteroid. Internationally, MF is~     administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be~     administered through a monodose device that would offer an alternative to MF DPI multidose~     treatment in terms of cost-effectiveness were developed in Brazil. The aim of the present~     non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety.~   "
197671|NCT00975728|"~     The purpose of this study is to evaluate the antioxidant activity on skin photo induced~     damage of a food supplement and its anti-age properties.~   "
197672|NCT00975715|"~     This study is designed to provide short term efficacy and safety data of TRI476 in children~     with inadequately-controlled partial seizures. Patients will be randomized into either drug~     treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks.~     The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.~   "
197673|NCT00975702|"~     Does remote ischemic preconditioning (RIPC) induced by a brief period of occlusion of blood~     flow to the lower extremity prior to organ recovery in deceased donors, improve short and~     long term outcomes after transplantation of kidneys, livers and pancreas? To test this~     hypothesis deceased organ donors will be randomized to receive either RIPC or No RIPC before~     organ recovery. RIPC will be induced in the operating room after commencement of procurement~     surgery. RIPC will be induced by tourniquet-induced occlusion of blood flow to the lower~     extremity for 10 minutes in each side, for a total duration of 20 minutes. The remainder of~     the organ recovery and organ preservation will be as per standard of practice. Recovered~     livers, kidneys and pancreas will be transplanted into allocated recipients. Transplantation~     and patient management after transplantation will be as per standard of practice.~      Organ-specific function and cell injury parameters will be utilized to assess the early~     postoperative outcomes of individual organs and recipients. Long term outcomes will be~     assessed by graft and recipient survival.~   "
197674|NCT00975689|"~     Background:~        -  Niemann-Pick disease type C (NPC) is a genetic disorder that results in progressive loss~          of nervous system function by affecting the membranes of nerve cells. There is no known~          cure for NPC.~        -  N-acetyl cysteine (NAC) is a drug that has been approved by the Food and Drug~          Administration to use either orally or IV for the treatment of acetaminophen (Tylenol)~          poisoning or as an aerosol to reduce the stickiness of mucous in patients with cystic~          fibrosis. In the body, NAC is converted to an amino acid called cysteine, which cells~          can convert to a chemical called glutathione. Glutathione is important in helping cells~          deal with oxidative stress. Based on a number of experiments in cells, mice and patients~          with NPC, we believe that oxidative stress is increased in NPC. If we can increase~          glutathione levels, we may be able to decrease the oxidative stress.~      Objectives:~      - To test the safety and effectiveness of N-acetyl cysteine to treat Niemann-Pick disease~     (type C).~      Eligibility:~      - Individuals at least 1 year of age who have been diagnosed with NPC.~      Design:~        -  Patients entering this study will be seen at the National Institutes of Health Clinical~          Center four times during the 20 weeks of the study. These admissions will occur at the~          start of the study and at weeks 8, 12, and 20. The first NIH visit will last 2 days, and~          the other visits will last 1 day.~        -  Patients will participate in a two-stage study: a period of 8 weeks receiving NAC and a~          second period of 8 weeks when receiving a placebo (a pill without NAC). Every patient~          participating in this study will receive NAC during one of the two time periods.~        -  The two treatment periods will be separated by a wash-out period, 4 weeks when patients~          will receive neither NAC nor placebo. Patients will also have a 4-week wash-out period~          at the beginning of the study. Most physician-prescribed medications, such as seizure~          medications, will be allowed.~        -  During each visit, examinations, procedures, and tests will be done, including blood and~          urine samples.~   "
197675|NCT00975676|"~     RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may~     help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane~     works in lowering estrogen levels.~      PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have~     undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or~     exemestane on clinical trial IBCSG-2402.~   "
197676|NCT00975663|"~     The purpose of this study is to evaluate in lung or heart-lung transplant patients on~     tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug~     monitoring and dose adjustment of both drugs on the incidence of treatment failure over the~     first three years post-transplantation.~   "
197677|NCT00975650|"~     This clinical trial is being performed to compare the pharmacokinetic profile of testosterone~     after repeated intra-nasal administration of products of different strengths in subjects with~     hypogonadism.~   "
197678|NCT00975637|"~     The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent~     of improvement in PASI score at week 12.~   "
197679|NCT00975611|"~     The purpose of this study is to show that amantadine might help to reduce the side effect of~     the medications which are prescribed to treat schizophrenia or schizoaffective disorder. High~     level of hormone prolactin, or hyperprolactinemia, is one of the side effects which might be~     developed in patients treated with the paliperidone ER or risperidone Consta.~      High level of prolactin might stimulate breast development, might decrease sexual desire~     (libido). The goals of this study are to demonstrate that amantadine lowers prolactin levels,~     decreases side effects, and improves psychiatric symptoms.~   "
197680|NCT00975585|"~     The purpose of this study is to compare the clinical performance of two contact lenses.~   "
197681|NCT00975572|"~     The primary safety objective of this study is to assess the safety of split- virion~     inactivated H1N1 vaccine with and without adjuvant when administered at the 7.5,15 or 30 mcg~     dose. The primary immunogenicity objective is to assess the antibody response following each~     dose of split- virion inactivated A(H1N1) vaccine with and without adjuvant. Participants~     will include up to 2200 healthy persons age 3 and older who have no history of novel~     influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized,~     double-blinded, Phase II study in healthy males and non-pregnant females, aged 3 years and~     older. Subjects will be stratified by elders (equal to or more than 61 years), adults (18-60~     years), adolescents (12-17 years) and children (3-11 years), elders and adolescents will be~     randomized into 5 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or~     non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), children will be randomized into 4~     dose groups (adjuvanted H1N1 vaccine of 7.5 or 15 mcg per dose or non-adjuvanted H1N1 vaccine~     of 15 or 30 mcg per dose), adults will be randomized into 6 dose groups (adjuvanted H1N1~     vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose~     or placebo), 110 subjects per dose and age stratum will be to receive intramuscular influenza~     H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. Following~     immunization, safety will be measured by assessment of adverse events through 21 days~     following the last vaccination (Day 42 for those receiving both doses), serious adverse~     events and new-onset chronic medical conditions through 6 months post the final vaccination~     (Day 180 after second vaccination), and reactogenicity to the vaccine for 8 days (Day 0-7)~     following each vaccination. Immunogenicity testing will be hemagglutination inhibiting (HAI)~     on serum obtained on the day 21 of each vaccination (prior to vaccination), on Day 21 after~     first vaccination, and 21 days following the second vaccination (Day 42).~   "
197682|NCT00975559|"~     The aim of this study is to measure how different people respond to mental stress. The~     investigators will measure if there are differences in cardiovascular responses to mental~     stress among different groups of subjects. In one part of the study the investigators will~     compare the cardiovascular responses to mental stress between healthy women and healthy men.~     In another part of the study, the investigators will compare the cardiovascular responses to~     mental stress between women with apical ballooning syndrome and healthy post-menopausal~     women. The investigators hypothesize that healthy men will have an increased vascular~     response to and decreased endothelial function in response to to mental stress, compared to~     health women. Furthermore, the investigators hypothesize that women with apical ballooning~     syndrome will have an increased vascular response to and decreased endothelial function in~     response to mental stress.~   "
197683|NCT00975546|"~     The investigators propose to treat couples who wish to have a child in which the man is~     HIV-positive and the woman is HIV-negative. The investigators call these couples~     HIV-discordant. On the average, an HIV-positive man, who does not participate in high-risk~     activities, will transmit HIV to a female partner one in every one thousand acts of~     intercourse without a condom. To reduce transmission of HIV, HIV-discordant couples are~     counseled to avoid intercourse altogether, or to use condoms during every act of intercourse.~     In order to have a child, these patients can use donor insemination. If they wish to have a~     natural child of the infected man, they can use a combination of medication of the man to~     reduce the amount of virus in his semen, and condom use except at the time of ovulation when~     the woman produces an egg. This reduces the chance of infecting the woman, but studies have~     shown that about 4% of women will be infected with HIV using this approach. Alternatively,~     they can use vitro fertilization (IVF) with intra cytoplasmic sperm injection (ICSI) in which~     eggs are collected from the woman after hormone-stimulation and are fertilized in the~     laboratory by injecting a single washed sperm from her husband into each egg. The resulting~     embryos can be transferred to the wife's uterus and/or frozen for later use. These procedures~     are believed to minimize the risk of HIV transmission (although the number of cases is low),~     but IVF-ICSI is very expensive and are not an option for everyone. A simpler method used for~     over 15 years in Europe is to collect the man's semen, wash the sperm in the laboratory, and~     test the sperm sample for HIV before placing it in the woman's uterus (intrauterine~     insemination; IUI). Although the risk of HIV transmission to the woman is presumably not zero~     with this method, over 4000 inseminations reported have not resulted in infection of any~     female patients or resulting children.~   "
197684|NCT00975533|"~     This study aims to analyze the pre- and post-operative clinical, hormonal and biochemical~     changes in moderately obese type 2 diabetic patients who are sub-optimally controlled on at~     least 2 anti-diabetic agents. Study participants will either receive implantation of the~     gastric contraction modulator or conventional treatment with insulin therapy.~   "
197685|NCT00975520|"~     This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus~     post-operative radiation therapy for patients with completely resected primary melanoma~     showing histological features of neurotropism. Uncontrolled studies suggest that this form of~     primary melanoma has a high risk of local recurrence and that postoperative radiation therapy~     may substantially reduce that risk. Patients who are eligible on the basis of the pathology~     of the excised melanoma will be offered the opportunity to take part in the trial. Those~     randomised to receive radiation therapy will be treated with a simple technique encompassing~     the surgical bed plus a margin. Radiation will commence within 3 months of surgery (maximum~     of 14 weeks from surgery to start of radiotherapy).~   "
197686|NCT00975507|"~     This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant~     administration of Varivax and M-M-R II vaccines in healthy children.~   "
197687|NCT00975494|"~     In heart failure (HF), a defective nitric oxide (NO) signaling may be involved in left~     ventricular (LV) diastolic abnormalities and LV remodelling progression. PDE5-inhibition, by~     blocking NO degradation and overexpressing cellular cyclic guanosine monophosphate (cGMP)~     pathways might be beneficial. Several short term studies have demonstrated safety and~     clinical improvement in stable heart failure (HF) patients.~      The purpose of this study is to test the effects on LV diastolic function, cardiac geometry~     and clinical status in a cohort of HF patients.~   "
197688|NCT00975481|"~     Dimebon will not exhibit abuse potential when compared to placebo or a positive control~     (alprazolam).~   "
197927|NCT00972322|"~     This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering~     activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study~     is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted~     mean glucose (WMG) from baseline than placebo.~   "
197689|NCT00975468|"~     Compared with the information available in sepsis and trauma-associated ARDS, less is known~     about the cause and pattern of lung injury after thoracic surgery. Definition of lung injury~     in this context is difficult. Most now use the joint North American-European consensus~     conference definitions, but these are based only on gas exchange and radiology criteria.~     While gas exchange measures are reliable, thoracotomy inevitably causes radiological change~     and the interpretation of plain chest films becomes subjective. Definitions based on~     permeability and inflammatory changes would improve diagnosis, but are not routinely~     available in most units.~      Pressure-controlled volume (PCV) may be useful to improve gas exchange and alveolar~     recruitment with associated lower airway pressures and shunt fraction during one-lung~     ventilation (OLV).~      However, a recent prospective randomized study of the effects of PCV during OLV did not lead~     to improved oxygenation during OLV compared with VCV, but PCV did lead to lower peak airway~     pressures. To date, there are no reports of the effects of PCV versus VCV during OLV on the~     acute lung injury (ALI) after thoracotomy.~   "
197690|NCT00975455|"~     The purpose of the study is to evaluate subjects with gross or microscopic hematuria~     undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.~   "
197691|NCT00975442|"~     The purpose of this study is to evaluate eccentric training as an intervention for lateral~     epicondylalgia (tennis elbow) in a clinical setting.~   "
197692|NCT00975429|"~     The aim of this trial is to determine the optimal treatment conditions to achieve prostate~     cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted~     Photodynamic therapy (VTP) treatment in patients with localized prostate cancer.~      The secondary objectives are to assess the safety and quality of life following~     WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a~     second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the~     duration of the VTP procedure.~   "
197693|NCT00975416|"~     Background:~      - The therapeutic alliance between therapist and patient may contribute to favorable outcomes~     in all types of psychotherapy, including cognitive behavioral therapy (CBT) for drug~     dependence. Oxytocin, a hormone and neurotransmitter, has been shown to increase trust in~     other people and may reduce stress and improve comfort in social situations by decreasing the~     sensation of social anxiety. Researchers are interested in determining if oxytocin can~     improve the outcomes of therapy for drug dependence by strengthening perceived levels of~     trust between therapist and patient.~      Objectives:~      - To determine whether oxytocin enhances the therapeutic alliance and treatment retention for~     CBT for drug use.~      Eligibility:~      - Individuals between 18 and 65 years of age who are healthy volunteers with no history of~     drug abuse, participants in outpatient or inpatient treatment programs for cocaine use,~     methadone-dependent participants in a treatment program, or non-treatment-seeking cocaine~     users.~      Design:~        -  Participants in each treatment arm who comply with the study requirements will be~          randomly assigned to receive one dose of oxytocin or placebo approximately 1 hour before~          each weekly CBT session.~        -  The outpatient treatment intervention will be 12 weeks of weekly individual CBT. The~          inpatient treatment intervention will be 6 weeks of twice-weekly individual CBT~          sessions. Sessions will be audiotaped. Participants and counselors will be told that the~          sessions are to be taped.~        -  During treatment, participants will provide urine and breath samples under staff~          observation. Participants will also complete questionnaires about mood and mental~          health, provide other samples as required, and participate in computerized psychological~          testing as directed by researchers.~   "
197694|NCT00975403|"~     Chronic obstructive pulmonary disease (COPD) is a growing cause of death, disability and~     health care costs in Canada. Nevertheless, COPD remains largely under-diagnosed and~     under-treated, particularly in its early stages. Patients with mild COPD have variable~     respiratory symptoms and often go unrecognized by their caregivers. Recent studies indicate~     that even smokers with near normal breathing test results can have extensive small airway~     disease/dysfunction at rest, which becomes more pronounced during the stress of exercise thus~     leading to unpleasant breathing difficulty. This study seeks to better understand the nature~     and causes of breathing discomfort and activity limitation in a group of patients with mild~     COPD. The investigators will compare detailed tests of small airway function and conduct an~     evaluation of several key physiological parameters during the stress of exercise in patients~     with mild COPD and in healthy, age-matched, non-smoking control subjects. The investigators~     will also compare detailed physiological responses to exercise under conditions of chemical~     loading and mechanical unloading of the respiratory system in patients with mild COPD.~      The proposed study will be the first to systematically test the hypothesis that~     pathophysiological abnormalities in ventilatory demand, pulmonary gas exchange, small airway~     function, dynamic ventilatory mechanics and respiratory muscle function contribute~     significantly to exertional dyspnea and activity-limitation in patients with mild COPD. This~     study will be the first to determine if these abnormalities can be manipulated.~   "
197695|NCT00975390|"~     The aim of the present study is to investigate the effect of added protein+leucine or~     caffeine to 1.2 g/kg/h CHO on the rate of post-exercise muscle glycogen re-synthesis in~     healthy, recreational athletes.~      The investigators hypothesize that both interventions (the addition of caffeine or~     protein+leucine) will lead to higher glycogen re-synthesis compared to the ingestion of CHO~     only, and that the co-ingestion of protein and leucine will result in the highest muscle~     glycogen synthesis rates.~   "
197696|NCT00975377|"~     The objective of this study is to determine whether hair clipping is non-inferior to no hair~     removal in preventing superficial, deep, and organ space surgical site infections (SSI) in~     patients undergoing various general surgical procedures, evaluated after surgery by an~     assessor blinded to treatment allocation. Additional goals include evaluating wound~     complications that arise in patients that have hair clipped and in patients that do not have~     hair removed and determining the impact of clipping versus no hair removal and SSI versus no~     SSI on length of hospital stay.~   "
197697|NCT00975364|"~     This pilot study is designed to investigate differences in folate-related genes (single~     nucleotide polymorphisms) and their relationship to the species of folate present on red~     blood cells.~   "
197698|NCT00975351|"~     The aim of this study is to calculate the plasma apparent volume of distribution of natural~     folate to give a more accurate value for use in a mathematical model of apparent folate~     absorption.~   "
197708|NCT00975208|"~     The closure of the alveolar cleft as part of cleft lip and palate deformities is a procedure~     that, to this date, still demands great efforts from plastic surgeons. The feasibility of~     periosteoplasty for reconstruction of the alveolar arcade as well as the use of electrical~     stimulation in order to increase osteoneogenesis have been proven in the past. The present~     study attempts to combine both procedures that have only been reported separately worldwide.~     The objective of this study is to increase the osteogenic capacity and hence, dental~     eruption.~   "
197699|NCT00975338|"~     This project will describe and evaluate the impact of a unique partnership model designed to~     coordinate transfer of care by formally linking pediatric and adult heath care services. The~     experiences of young people receiving this model of care will be compared and contrasted~     against the experiences of young people receiving the current standard of care. Young people~     with a diagnosis of CP, ABIc, and SB will be followed during the transition period.~     Preparation for transition, health care, and transfer of care service delivery will be~     detailed in a process evaluation. An outcome evaluation will measure the ability of the two~     models of service to enable youth to maintain continuity within the health care system after~     transitioning from pediatric to adult care. Secondary outcomes, including how health,~     well-being, social participation, transition readiness, and health care utilization are~     affected will also be explored.~   "
197700|NCT00975325|"~     -  Type: Bioequivalence study in male healthy volunteers, therapeutical indication~          (erectile disfunction) not studied~        -  Products, dosage, and route of administration:~             -  Test 1: Yohimbin Spiegel® (Desma GmbH, Germany), tablet containing 5 mg yohimbine~               hydrochloride, oral administration~             -  Reference: Yocon-Glenwood® (Glenwood GmbH, Germany), tablet containing 5 mg~               yohimbine hydrochloride, oral administration~        -  Duration of treatment:~           2 single-dose administrations of 5 mg yohimbine hydrochloride each under fasting~          conditions separated by a wash-out period of at least one week i.e. 6 treatment free~          days between all administrations~   "
197701|NCT00975312|"~     Background~        -  Lentigines are usually the first sign of photoaging and may produce a significant impact~          on patients' quality of life.~        -  There is no a treatment of choice for this condition.~        -  Solar lentigines and melasma share similar physiopathologic characteristics.~        -  The triple combination (TC) cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone~          acetonide 0.01%) has been effective and safe for the treatment of melasma and other~          hyperpigmented lesions.~      Hypothesis~      * The TC cream will be effective and safe for the treatment of solar lentigines on the back~     of the hands.~      Patients and methods~        -  22 patients with solar lentigines were selected and their right hand or left hand were~          selected at random to be treated with either TC cream or tretinoin 0.05% cream once~          daily for up 12 weeks.~        -  Patients were instructed to apply both creams on the whole back of the hand and not only~          in the lentigines, and to use a broad-spectrum sunscreen (SPF 50+, UVA-PF 28) daily in~          both hands.~        -  Clinical assessments of Target Lesion Pigmentation, Physician's Global Assessment of~          Improvement and a Subject's Self-Assessment questionnaire were collected for data~          analysis at weeks 4, 8, and 12 after starting the treatment and 3 month post-treatment.~        -  Statistical methods: The ordinally scaled efficacy measures underwent rank~          transformation and were analyzed by analysis of variance to test the null hypothesis of~          no differences among treatments. We performed Mann-Whitney and Wilcoxon tests and the~          XLSTAT 2009 software was used.~   "
197702|NCT00975299|"~     Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)~     images obtained after a single intravenous injection of BAY86-4367 in patients with cancer~   "
197703|NCT00975286|"~     The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in~     comparison to placebo, as an add-on treatment to insulin glargine and metformin with or~     without thiazolidinediones (TZDs), over a period of 24 weeks of treatment.~      The primary objective is to assess the effects of lixisenatide in comparison to placebo, when~     added to insulin glargine and metformin, on glycemic control in terms of glycosylated~     hemoglobin (HbA1c) reduction (absolute change) at Week 24.~      The secondary objectives are to assess the effects of lixisenatide on the percentage of~     patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%,~     plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self~     monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability~     (including anti-lixisenatide antibody assessment), and to assess the impact on treatment~     satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the~     participating countries where it is validated.~   "
197704|NCT00975273|"~     For the proposed randomized controlled treatment study, the investigators plan to compare the~     effects of this hypoventilation-based breathing training with a control intervention that~     will focus on breathing regularity and awareness. The two therapeutic procedures are closely~     matched on important variables such as duration and the nature of patient-therapist~     interaction, monitoring asthma related status and the medication intake, use of scientific~     equipment and monitoring devices to increase adherence, and initial plausibility. Asthma~     patients who will be evaluated before, during, directly after, and at 2 months and 6 months~     after training.~   "
197705|NCT00975247|"~     Background: Achievement of colonoscopy outcomes depends on high-quality bowel preparation by~     patients; yet inadequate preparation is common.~      Objective: To develop and test an educational booklet to improve bowel preparation quality.~      Design: Before-and-after study followed by randomized controlled trial.~      Setting: Veteran Affairs medical center.~      Patients: Patients undergoing outpatient colonoscopy~      Measurements: The investigators first performed cognitive interviews to identify knowledge~     and belief barriers to high-quality colonoscopy preparation. The investigators then created a~     patient educational booklet addressing patient barriers to improve preparatory behaviors. The~     investigators tested the booklet in 2 sequential studies: (1) controlled before-and-after~     study in patients undergoing colonoscopy during 2 consecutive months: 1 without and 1 with~     the booklet; (2) randomized controlled trial. The outcome in both studies was bowel~     preparation quality measured on a 6-point Likert scale (>5=good). In each study the~     investigators compared the proportion achieving a good preparation between groups and~     performed logistic regression to measure the effect of the booklet on preparation quality~     while adjusting for the purgative received.~      Limitations: Unknown impact on polyp yield and cancer reduction.~   "
197706|NCT00975234|"~     The purpose of this study is to determine the benefit of autologous skeletal myoblast~     injection in patients with old myocardial infarction and ventricular dysfunction versus~     conventional revascularisation therapy.~   "
197707|NCT00975221|"~     This study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for~     the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom~     parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but~     who are unable to undergo parathyroidectomy.~   "
197709|NCT00975195|"~     This is a randomised study to be conducted in patients with severe to very severe Chronic~     Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients~     to be continuously treated with an inhaled corticosteroid on top of two potent long-acting~     bronchodilators. The study also aims to identify the type of patients who are likely to~     benefit from inhaled corticosteroid maintenance therapy.~   "
197710|NCT00975182|"~     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination~     with PO erlotinib in patients with advanced solid tumors and patients with locally advanced~     or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior~     chemotherapy regimen.~   "
197711|NCT00975169|"~     According to the above evidence, though the exact mechanism contributing to the~     Thiazolidinediones (TZDs) associated peripheral edema is still unclear, the investigators~     hypothesize that the genetic variations of certain candidate genes involved in peroxisome~     proliferator-activated receptor (PPAR) gamma itself and PPAR gamma-regulated genes may~     contribute to TZDs-associated peripheral edema. Therefore, the investigators plan to conduct~     a case-control study to test the association between single nucleotide polymorphisms (SNPs)~     in certain candidate genes and TZDs related peripheral edema.~      A large fraction of individuals, both with type 2 diabetes (38-41) or who are at risk for~     type 2 diabetes, do not respond to TZD therapy. In individuals with type 2 diabetes,~     non-response has not been carefully characterized, but data from studies in at-risk~     individuals suggests that a lack of improvement in insulin sensitivity (Si) may account for~     the lack of response to TZD therapy. In the Troglitazone In the Prevention Of Diabetes~     (TRIPOD) study, around 30% of treated women did not show an improvement in Si; they gained no~     protection from type 2 diabetes when compared with the placebo group. Assessment of baseline~     clinical and physiologic measurements revealed similar levels of adiposity, fasting glucose~     and insulin, Si and β-cell function, fasting lipids, contraceptive use, and compliance with~     study medication between responders and nonresponders, suggesting that these measures do not~     predict TZD response.~      The adipose tissue-derived hormone adiponectin improves insulin sensitivity and its~     circulating levels are decreased in obesity induced insulin resistance. In ob/ob mice lacking~     adiponectin, the ability of PPARγ agonists, TZDs, to improve glucose tolerance is diminished.~     It implied that adiponectin is an important contributor to PPARγ-mediated improvements in~     glucose tolerance through mechanisms that involve the activation of the AMPK pathway. On the~     other hand, it has been shown that FOXO1 repressed PPARγ1 and γ2 promoters in primary~     adipocytes. It has also been reported that peroxisome proliferators activated receptor-γ~     coactivator-1α (PGC-1α) gene expression in brown and white adipocytes is a direct target of~     TZDs and activators of retinoid X receptor (RXR). Taken together, both FOXO1 and PGC-1α~     potentially played important roles on the antidiabetic action of TZDs.~      In summary, though TZDs have been widely used in patients with type 2 diabetes mellitus, some~     of patients experienced TZD-related peripheral edema and some of patients had no good~     responsiveness to TZDs. The underlying contributing factors and molecular mechanisms have not~     been clearly elucidated. In this study, the investigators will identify the contributing~     factors of TZD-related peripheral edema and responsiveness to TZDs. The investigators will~     also identify the association of single nucleotide polymorphisms (SNPs) of certain candidate~     genes with TZD related peripheral edema and responsiveness to TZDs. It may identify some~     clinical and pharmacogenetic factors to predict the occurrence of TZD-related edema and the~     responsiveness to TZDs.~   "
197712|NCT00975156|"~     The purpose of this research study is to look at a new rehabilitation technique for~     individuals who have suffered a stroke and have difficulties walking. This study is designed~     to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in~     order to improve walking post-stroke. This research project will be conducted as a pilot~     randomized controlled trial that compares the effectiveness of Lokomat versus conventional~     physical therapy in improving the ambulation and gait of chronic stroke patients. The project~     will provide important pilot data that could indicate whether or not the effectiveness of~     Lokomat training is superior to that of standard physical therapy and if a definitive and~     larger clinical trial is warranted.~   "
197713|NCT00975143|"~     The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a~     marketed (generic) formulation of isotretinoin when both are administered twice daily with~     meals.~   "
197714|NCT00975130|"~     Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab~     administered by autoinjector once monthly, when combined with different disease-modifying~     antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2~     will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC~     golimumab to retain remission is superior to continuing a SC regimen.~   "
197715|NCT00975117|"~     The purpose of this study is to determine whether the administration of the dietary~     supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility~     unrelated to major testicular conditions. The duration of this double-blind placebo~     controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with~     infertility to be recruited and randomized for the study is 86.~   "
197716|NCT00975104|"~     Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and~     Efficacy of AMG 745 in Age-associated Muscle Loss~   "
197717|NCT00975091|"~     The purpose of the study is to determine if treatment with entecavir is safe and well~     tolerated in patients who completed dosing in a previous entecavir study in China, but are~     requiring further treatment of their chronic hepatitis B virus infection.~   "
197718|NCT00975078|"~     Suppression of the adrenal function is a common, potentially dangerous and unpredictable~     consequence of short term high dose glucocorticoid treatment. Identification of patients at~     risk would be of high clinical importance. The investigators hypothesized that the~     dexamethasone-suppression-test predicts the subsequent development of corticosteroid induced~     adrenal insufficiency.~   "
197719|NCT00975065|"~     The study design of this trial is open-label, randomized, multi-center, parallel-group study.~   "
197720|NCT00975052|"~     This study will determine the effect of concomitant administration of sitagliptin and~     metformin on post-meal incretin hormone concentrations in healthy adults.~   "
197721|NCT00975039|"~     The aim of this study is to evaluate the safety of Vascular Targeted Photodynamic therapy~     with WST11 in patients with non-resectable or inoperable biliary carcinoma.~   "
197722|NCT00975026|"~     The purpose of this study is to determine whether the effects of chair massage and/or chair~     massage with stretching may reduce musculoskeletal pain and discomfort related symptoms~     associated with the job duties of a cardiac sonographer.~   "
197723|NCT00975013|"~     The objective of this study is to assess changes bone mineral density and bone metabolism~     after laparoscopic Roux-en-Y gastric bypass surgery. The investigators hypothesize that~     weight loss after laparoscopic Roux-en-Y gastric bypass surgery will be associated with~     increased bone turnover, changes in bone metabolism, and loss of bone mass.~   "
197744|NCT00974740|"~     Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on~     beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent~     immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of~     beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated~     C-peptide levels.~   "
197745|NCT00974727|"~     The purpose of this study is to examine the impact of a summer gardening program on summer~     weight gain in overweight middle school children.~   "
197724|NCT00975000|"~     Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT~     often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the~     neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can~     cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT~     may include increases in blood levels of calcium (hypercalcemia) and low blood levels of~     phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body~     tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation,~     itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant~     dysfunction (worsening of kidney transplant function). The purpose of this study is to~     evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in~     patients with HPT after a kidney transplant.~   "
197725|NCT00974987|"~     RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and~     other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving boron neutron capture therapy followed by~     radiation therapy and temozolomide may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture~     therapy together with radiation therapy and temozolomide in treating patients with newly~     diagnosed glioblastoma multiforme.~   "
197726|NCT00974974|"~     This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's~     disease.~   "
197727|NCT00974961|"~     The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous~     system smaller than that of bupivacaine.~   "
197728|NCT00974948|"~     Pancreatic cancer presents with pain in the majority of cases. Destruction of the celiac~     ganglia by ultrasound guided injection of sclerosing agents such as alcohol is sometimes used~     for pain that no longer responds to treatment with narcotics. The investigators compare~     standard narcotic treatment to celiac plexus alcohol injection (celiac plexus neurolysis) and~     do so in patients with early, mild pain to see if celiac plexus neurolysis is more effective~     than narcotics and prevents escalating narcotic use.~   "
197729|NCT00974935|"~     The main purpose of this study is to test the safety of a new vaccine, STEBVax, which may~     lead to a useful treatment for toxic shock syndrome. The second purpose is to determine~     whether STEBVax causes the body to produce antibodies (proteins that fight infection) to help~     the body resist disease. Researchers expect STEBVax shots will cause the development of~     antibodies in the blood. Study participants will include up to 42 healthy adults, ages 18-40,~     from the University of Maryland Baltimore community. Participants will be assigned to one of~     7 vaccine dose groups. Assignment to dosage groups will depend on when individuals are~     enrolled in the study. Study procedures will include blood sampling, urine collection, and~     physical examinations. Subjects will maintain a memory aid documenting daily oral~     temperatures and possible vaccine side effects. Participants will be involved in study~     related procedures for up to 201 days.~   "
197730|NCT00974922|"~     This study will evaluate the effects of Vitamin D replacement and the effects of an approved~     medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who~     have low levels of vitamin D in their blood. The study will compare the effects of vitamin D~     or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.~   "
197731|NCT00974909|"~     Background of the study:~      Fecal incontinence is a complex problem. The social consequences of this problem result in a~     lower quality of life. The exact prevalence of FI is unknown, literature reports vary from~     13-19%. There are variable treatment options depending on the patient and the etiology of the~     FI. Dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well~     as surgical interventions are currently used to treat FI.~      A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS). The nerves in~     the spine that control bowel function also have branches which go to the ankle. Stimulating~     these nerves in the ankle has shown to be an effective treatment for FI in the short-term.~     The treatment has been shown to be safe and well tolerated by subjects with almost no~     morbidity in prior urology trials.~      Objective of the study:~      The objective of this study is to show that the results of PTNS are based on the treatment of~     electrical stimulation and not on a placebo effect with a sham treatment.~      Study design:~      This study is a multicenter, single-blinded, randomized, placebo-controlled trial.~      Primary study parameters/outcome of the study:~      The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from~     baseline after 9 weeks of treatment.~      Secondary study parameters/outcome of the study (if applicable):~      Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score)~      Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive~     Health Status Instrument (DHSI), and Fecal Incontinence Quality of life)~      Subject's and Physician's Global Impression~   "
197732|NCT00974896|"~     To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in~     combination with bevacizumab, sorafenib, panitumumab, erlotinib, or gemcitabine in subjects~     with advanced solid tumors. Up to 126 subjects may be enrolled. Sorafenib and erlotinib combo~     cohorts are enrolling. All other combo cohorts are closed to enrollment.~   "
197746|NCT00974714|"~     The purpose of this study is to evaluate the effects of oral L-arginine administration on~     pregnant women at second trimester of gestation with chronic hypertension, respect with~     placebo.~   "
197747|NCT00974701|"~     This study is aimed at assessing the capability of the PillCam Platform using the PillCam ESO~     2 Capsule in:~        -  Determining whether there is 1) active bleeding in the Upper gastrointestinal (UGI)~          tract, 2) identifying the anatomic location of acute overt UGI bleeding, and 3)~          discriminating a variceal versus non-variceal source of UGI bleeding.~   "
197748|NCT00974688|"~     Quality of life and heart health are intimately connected to childhood physical activity~     participation (PAP). Physical activity is critical to childhood growth, development,~     learning, socialization, and quality of life and is an essential component of life-long heart~     health. Research by the investigators of this study and others has shown that low PAP levels~     are common among children with heart defects, and that these sedentary lifestyles are not~     related to exercise capacity, medical status or heart function.~   "
197749|NCT00974675|"~     The study includes participants with moderate asthma who were randomly assigned to receive~     the study medication (CAT-354) or placebo.~   "
197733|NCT00974883|"~     Giant Cell Arteritis (GCA) causes inflammation and narrowing of blood vessels and can cause~     blindness in one third of patients. It is important that a prompt, accurate diagnosis of GCA~     is made and treatment given as steroids for two or more years. Currently there is no 100%~     accurate test for GCA. Patients usually have new headache and scalp tenderness, typically~     with an abnormal blood test. However, it can be difficult to distinguish non-serious forms of~     headache from GCA; infection produces similar abnormal blood results. If there is a suspicion~     of GCA, treatment with steroids is started straight away. To confirm a diagnosis, the patient~     will need a biopsy of a temporal artery (a minor procedure performed under local anaesthetic~     to remove a sample of one of the scalp arteries). However, up to 44% of patients will have a~     normal biopsy. Therefore it is difficult to know if a patient with a normal biopsy does or~     does not have GCA. Withdrawing steroid treatment may increase the risk of blindness.~     Continuing treatment in a patient without GCA increases the risk of side effects (e.g.,~     weight gain, infection risk, osteoporosis and fracture risk, high blood pressure, diabetes,~     cataracts). It is important to improve diagnostic tests for GCA. Another test to help in~     diagnosing GCA is an ultrasound scan of the arteries in the side of the head and under the~     arms. Ultrasound does not involve surgery; it is a simple test which can be performed as an~     out patient. Gel is applied to both sides of the head and under each arm. A sound probe is~     placed over the artery at each site to produce the scan.~      The investigators' study will examine the role of ultrasound in diagnosis of 402 patients~     with suspected GCA. All patients will have an ultrasound examination in addition to biopsy~     within a week of starting steroids. Patients will be treated according to usual practice.~     After six months, the investigators will reassess the diagnosis. The investigators will look~     at the accuracy of ultrasound compared with or combined with biopsy. The investigators will~     look at how a doctor's knowledge of ultrasound results or biopsy results alone would affect~     the diagnosis and recommendation to continue or stop steroid treatment. The investigators~     will assess whether knowledge of both results together would alter the diagnosis and~     treatment. The investigators will collect information to estimate the costs of different ways~     of diagnosing GCA in relation to the impact on quality of life.~   "
197734|NCT00974870|"~     The primary objective of this study is to determine the efficacy of a needling device for~     treatment of acne scars.~   "
197735|NCT00974857|"~     This prospective, randomized, controlled study aims to evaluate the usefulness of the new~     body composition monitor (BCM) device as a method to improve volume control in hemodialysis~     (HD) patients and compare the results with those obtained by conventional volume control~     modalities.~   "
197736|NCT00974844|"~     Dropping of nucleus is a common complication during cataract extraction by~     phacoemulsification. The investigators describe a new technique to retrieve the dropped~     nucleus by using an instrument called Pars Plana Levitator (ASICO-LLC, USA).~   "
197737|NCT00974831|"~     The primary objective is to compare the postprandial glycemic response of healthy overweight~     adults after consuming an amino acid drink mix versus a control drink.~   "
197738|NCT00974818|"~     The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and~     Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will~     get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get~     both.~      The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the~     diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even~     after the doctor removes the tumors, the cancer can return. In this case, the doctor will put~     medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The~     two most commonly used drugs for this purpose are MMC and BCG.~      Both drugs have been studied for many years. They both show good results when compared to~     other treatments. They have not been studied using the schedule that will be used in the~     study. The doctor does not know if these two drugs are equally effective in treating the~     cancer and preventing recurrence.~      BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG~     is better than a short schedule of MMC. They have also shown that the side effects of BCG are~     more intense than with MMC. A recent study showed that a new dose of MMC is better than the~     old standard dose. Since the side effects of MMC occur less often, it is important to learn~     whether the two drugs are equally effective. That could help us decide between the~     treatments. In this study, the doctor will compare MMC and BCG when given for the same amount~     of time. The doctor hopes the study will tell us which drug is more effective in preventing~     the return of the cancer.~   "
197739|NCT00974805|"~     This study is investigating the possible mechanisms of action of an inhaled treatment~     (Seretide), currently used worldwide in millions of patients with COPD (Chronic Obstructive~     Pulmonary Disease) and how it improves the symptoms of these patients. Previous research has~     failed to identify the mechanisms at play other than dilation of the airways. The research~     community has long thought the mechanism to be immune based or anti inflammatory but despite~     intensive research this has not yet been identified.~   "
197740|NCT00974792|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as rituximab, can block cancer cell growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cell-killing substances to them. Giving more than one drug (combination chemotherapy)~     together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with rituximab works in treating patients with diffuse large B-cell non-Hodgkin lymphoma.~   "
197741|NCT00974779|"~     The purpose of this study is to test whether a dialyzer with a higher than usual permeability~     for proteins can eliminate proinflammatory proteins from the blood of patients on regular~     maintenance hemodialysis who have chronically elevated levels of inflammation markers such as~     C-reactive protein (CRP) in their blood.~   "
197742|NCT00974766|"~     Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex~     hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral~     corticosteroids are currently the treatment of choice for ABPA associated with bronchial~     asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory.~     However, there is no data to guide the dose and duration of glucocorticoids and different~     regimens of glucocorticoids have been used in literature. The disorder is highly prevalent in~     India. The investigators have previously reported their experience with screening stable~     outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have~     also recently reported the prognostic factors associated with clinical outcomes in patients~     with ABPA.~      The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and~     safety of two different glucocorticoid dose protocols in patients with ABPA.~   "
197743|NCT00974753|"~     Evaluate the efficacy of ketorolac 0.5%, a topical non-steroidal anti-inflammatory drug~     (NSAID), to prevent macular edema after epiretinal membrane surgery. Patients undergoing~     epiretinal membrane surgery have increased risk of macular swelling which can adversely~     affect vision. Since post-intraocular surgery inflammation is a contributing factor to~     macular swelling and loss of vision, NSAID drops may be able to prevent or minimize the~     deleterious effects of macular swelling after epiretinal membrane surgery.~   "
197751|NCT00974649|"~     The current study aims to explore and analyse the decision making process of couples in~     regards to continuing or discontinuing infertility treatment. A longitudinal, prospective~     cohort design is used which allows the monitoring of patients over a longer period of time.~     Data will be collected quantitatively (questionnaires) as well as qualitatively (in-depth~     interviews) to allow for a more specific and in depth experience than can be obtained by~     using a questionnaire study. Innovative aspects of the study include:~        1. exploration of determinants of continuing and discontinuing infertility treatment by~          using a comprehensive psychological theory (both surface and in-depth)~        2. exploration of gender differences in the decision making process in continuing or~          discontinuing treatment~        3. longitudinal and prospective arm of the study will allow to gain insight into the~          'process'~        4. prediction of continuing/discontinuing treatment based on psychological variables.~   "
197752|NCT00974636|"~     ABSTRACT~      Background:~      It is well recognized that excess dietary salt intake plays a major role in the development~     of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and water~     retention (excess volume) which is associated with hypertension.~      Hypotheses:~      Hypothesis 1:~      Dietary salt restriction will improve volume status in subjects with CKD stages 3-4 as~     assessed by Bioelectrical Impedance Analysis (BIA).~      Hypothesis 2:~      Dietary salt restriction will result in improved blood pressure control in patients with CKD~     stages 3-4.~      Hypothesis 3:~      Dietary salt restriction will decrease albuminuria in patients with CKD stages 3-4.~      Patients and Trial Design: This randomized crossover pilot study is designed to assess the~     effect of salt restriction on volume status in patients with CKD stages 3 and 4.~      Subjects will be randomized to a treatment order: (1) 4 weeks of salt restriction of <85 mmol~     sodium per day, a 2 week washout period, and 4 weeks of usual salt diet, OR (2) 4 weeks of~     usual diet, 2 weeks washout, and 4 weeks of salt restriction. Patients will receive dietary~     counseling in person at each study visit and at weekly intervals by phone calls from study~     dieticians. At weeks 0, 4, 6 and 10, patients will undergo assessments for (i) physical~     examination with assessments for weight, blood pressure, pulse, anthropometrics and a~     standardized clinical assessment of volume status. (ii) volume status using bioelectrical~     impedance analysis (BIA) (iii) 24-hour urine testing for, albumin, creatinine and aldosterone~     Every 2 weeks throughout the study, a 24-hour urine sodium will be measured for compliance,~     and serum electrolytes will be assessed for safety.~      Data Analysis: BIA measurements in the low salt group will be compared with the regular diet~     group using the standard linear model analysis for 2x2 crossover trials. Additionally,~     24-hour ambulatory and static blood pressure and 24-hour urine aldosterone levels will be~     compared between the two groups.~      Future Implications: A significant reduction in the degree of volume expansion (as assessed~     by BIA) and blood pressure as a result of a salt restricted diet would have implications for~     renal and cardiovascular protection and would warrant confirmation by a larger randomized~     trial.~   "
197753|NCT00974623|"~     A multi-center, prospective, observational patient registry to collect information on the~     clinical outcomes and real world use of approved and commercially available bone graft~     substitutes, autograft and allograft.~   "
197754|NCT00974610|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in peptides and proteins and identify biomarkers~     related to cancer.~      PURPOSE: This research study is looking at blood samples from patients with malignant~     melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal~     cancer.~   "
197755|NCT00974597|"~     The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of~     donor sites in burn surgery.~   "
197756|NCT00974584|"~     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with one of three~     planned regimens: Arm A: paclitaxel and carboplatin in bevacizumab-ineligible NSCLC patients,~     Arm B: paclitaxel, carboplatin, and bevacizumab in bevacizumab-eligible NSCLC patients and~     Arm C: pemetrexed, cisplatin, and bevacizumab in bevacizumab-eligible, non-squamous NSCLC~     patients.~   "
197757|NCT00974571|"~     This study will assess the ability of montelukast to improve the signs and symptoms of~     perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an~     active control.~   "
197758|NCT00974558|"~     The aim of the study is to investigate if the use of a handheld fan directed to the cheeks~     alongside conventional medical treatment partially or totally relieves breathlessness and if~     this effect lasts for at least 30 minutes in patients irrespective of the underlying disease~     process.~   "
197759|NCT00974532|"~     Subjects with normal kidney function are able to excrete in their urine the calcium and~     phosphorus absorbed via the gastrointestinal tract and are thereby are able to maintain~     calcium and phosphorus balance. Patients with chronic kidney disease often have normal blood~     levels of calcium and phosphorus but no research has been conducted to determine if they are~     able to excrete their daily intake of these minerals. If they are not able to excrete their~     daily intake, these minerals could be deposited in soft tissue and blood vessels and~     contribute to the increased risk of cardiovascular disease seen in patients with chronic~     kidney disease. This study will determine if subjects with chronic kidney disease are in~     balance primarily with regard to calcium and at what level of kidney function they are no~     longer able to maintain balance. Understanding whether patients with chronic kidney disease~     are in balance will help direct future therapeutic interventions.~   "
197760|NCT00974519|"~     Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The~     long-term clinical application has proved the safety and effect. It can improve the symptoms~     and signs in AIDS patients with the effective rate of 70% and can significantly improve the~     quality of life. It can also improve and stabilize immune function and inhibit viral~     replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral~     replication from multi-target, multi-link, enhance immune function, increase the secretion of~     IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote~     CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity.~   "
197761|NCT00974506|"~     In a randomized controlled pilot study the investigators include geriatric patients living in~     a geriatric residential community. Two interventions are compared:~        1. a complex intervention containing exercise therapy, nutritional advice, homeopathy and~          naturopathy in addition to routine therapy by the general practitioner~        2. routine care by general practitioner~      The investigators assess the effect of the complex intervention on activities of daily living~     (AMPS, Barthel Index, Nosger), quality of life (Qualidem, Profile of Wellbeing), risk of~     falls (Tinetti), falls, cognition (Minimental Status Test), hospital admissions, medication~     use.~      The results of this exploratory study are needed to plan a randomized controlled trial (RCT)~     with confirmatory design in the future.~   "
197778|NCT00974285|"~     The average period of asymptomatic HIV-infection is 8 years, at this stage, CD4+ T lymphocyte~     count was reduced gradually at the rate of 50~100cells/ul/year. When the CD4 T lymphocyte~     count dropped below 350cells/ul and viral load increased to 105 in AIDS patients, HAART will~     be carried out. But, CD4 T lymphocyte was 350~550 cells/ul, there is no intervention~     measures.~   "
197762|NCT00974493|"~     The study will compare the outcomes of treating bone and joint infections with 6 weeks of~     intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic~     strategy rather than of individual antibiotics. The study will be open label, but the~     primary outcome will be proven failure of infection treatment, determined by pre-established~     objective criteria for treatment failure. The null hypothesis tested is that there will be no~     difference in treatment failure rates.~   "
197763|NCT00974480|"~     Facial skin aging is a complex process combining factors such as sun exposure, smoking and~     those that are believed to be inherited. Changes in the skin over time including decreased~     thickness result in skin atrophy, wrinkling, sagging, yellowness and changes in pigmentation.~     Redermic is a cosmetic cream that has been evaluated clinically but not in comparison to~     tretinoin nor in combination with tretinoin. There is no data on the safety and efficacy of~     Redermic as compared to topical tretinoin.~      Rejuva is a cream currently approved by Health Canada for the treatment of photodamaged skin.~     It contains 0.025% tretinoin one of the most widely studied topical product for skin aging.~     Studies have shown that topical tretinoin increases collagen synthesis and epidermal~     thickness thereby improving the appearance of skin aging. The efficacy of Rejuva combined~     with another topical cosmetic cream such as Redermic in the treatment of skin aging is~     unknown.~      One hundred and twenty (120) subjects with signs of skin aging participated in this~     single-blind study to evaluate the efficacy and tolerance of Redermic versus Rejuva-A™~     (0.025% tretinoin) and Redermic in combination with Rejuva-A™ (0.025% tretinoin).~   "
197764|NCT00974467|"~     The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website~     to increase parent knowledge and skills.~   "
197765|NCT00974454|"~     Chinese prescriptions can inhibit viral replication according to the course of viral~     replication, and the effects is similar to the effect of HAART, and even better than the~     anti-viral and immune reconstitution of HAART due to its effect on improve immune system~     function. Over the past decades, many researchers have screened the effective Chinese~     medicines to treat AIDS.~   "
197766|NCT00974441|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 500~     mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that~     of Depakote® ER Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult~     subjects administered under fasting conditions.~   "
197767|NCT00974428|"~     The objective of this study is to determine the most effective dose of Wobenzym® N versus~     placebo at reducing pain severity as measured by the WOMAC pain score in subjects with~     symptomatic knee osteoarthritis (OA) at 6 weeks of treatment.~   "
197768|NCT00974415|"~     The primary objective of this study is to demonstrate the efficacy and safety of the carbon~     dioxide for subcutaneous fat reduction.~   "
197769|NCT00974402|"~     The purpose of this study is to evaluate Cognitive-behavioral therapy (CBT) for~     deployment-related post-traumatic stress disorder (PTSD) that can be used by behavioral~     health consultants working with Service Members in the primary care clinic. CBT is a~     well-researched, very effective individual (one-to-one) treatment that is designed to help~     people to directly deal with traumatic events they have suffered in the past, including~     combat. Many Service Members prefer to see behavioral health providers in primary care rather~     than the mental health clinic. The researchers hope to learn if a brief treatment for PTSD in~     primary care can be just as useful as more traditional treatment given in the mental health~     clinic. This study will enroll approximately 45 participants overall; with approximately 30~     participants at Wilford Hall Medical Center or Brooke Army Medical Center, and 15~     participants to be enrolled at the South Texas Veterans Health Care System over a period of~     one year.~   "
197770|NCT00974389|"~     RATIONALE: Drugs used in chemotherapy, such as S-1, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Giving S-1 together with bevacizumab may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving S-1 together with bevacizumab works~     as third-line therapy in treating patients with colorectal cancer that is recurrent or that~     cannot be removed by surgery.~   "
197771|NCT00974376|"~     This is a clinical study to evaluate the efficacy of the medication gabapentin in treating~     persons with cannabis dependence.~   "
197772|NCT00974363|"~     Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24~     months after vaccination and the subjects who were vaccinated in the primary study will be~     enrolled in this extension phase. No new subjects will be enrolled.~   "
197773|NCT00974350|"~     This is a research study testing SABER™-Bupivacaine (an experimental pain-relieving~     medication). SABER™-Bupivacaine is designed to continuously deliver bupivacaine, a common~     local anesthetic, for a few days in order to treat local post-surgical pain. This study is~     testing SABER™-Bupivacaine in people having surgery to repair a hernia.~      The purpose of the study is to measure and compare the safety (side effects), tolerability~     (ability to tolerate), and efficacy (how well it works) of two different volumes of~     SABER™-Bupivacaine with SABER™-Placebo.~   "
197774|NCT00974337|"~     The objective of this study is to estimate the prevalence of relative adrenal insufficiency~     in preterm very low birth weight infants with and without shock.~   "
197775|NCT00974324|"~     The role of angiogenesis has been less clear in lymphoma than in solid tumors, in part~     related to the heterogeneity of disease and technical issues. In addition to vascular~     endothelial growth factor (VEGF) effects on angiogenesis and the integrity of tumor~     vasculature, autocrine VEGF-receptor (VEGF-R)-mediated signaling may play a role in lymphoma.~     Microvessel density, a measure of angiogenesis, is highest in peripheral T-cell lymphomas~     (PTCL), followed by diffuse large B-cell (DLBCL) and intra-follicular follicular lymphoma~     (FL).~   "
197776|NCT00974311|"~     This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients~     with castration-resistant prostate cancer who have been previously treated with~     docetaxel-based chemotherapy.~   "
197777|NCT00974298|"~     The purpose of this study is to document the performance and clinical outcomes of uncemented~     total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand~     Center. The press-fit use technique is often used because of complications with cement~     loosening.~   "
197779|NCT00974272|"~     The primary goal of this study is to determine the acute effects of exenatide on postprandial~     hypertriglyceridemia. Secondary goals are to determine whether there are additional~     improvements in postprandial lipids and lipoproteins and whether (by the reduction of~     hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the~     pro-inflammatory potential of the postprandial period.~   "
197780|NCT00974259|"~     Traumatic brain injury (TBI) is a major cause of death and disability, with an estimated cost~     of 45 billion dollars a year in the United States alone. Every year, approximately 1.4~     million sustain a TBI, of which 50,000 people die, and another 235,000 are hospitalized and~     survive the injury. As a result, 80,000-90,000 people experience permanent disability~     associated with TBI. This project is designed to determine whether a device designed to~     measure brain tissue oxygenation and thus detect brain ischemia while it is still potentially~     treatable shows promise in reducing the duration of brain ischemia, and to obtain information~     required to conduct a definitive clinical trial of efficacy.~      A recently approved device makes it feasible to directly and continuously monitor the partial~     pressure of oxygen in brain tissue (pBrO2). Several observational studies indicate that~     episodes of low pBrO2 are common and are associated with a poor outcome, and that medical~     interventions are effective in improving pBrO2 in clinical practice. However, as there have~     been no randomized controlled trials carried out to determine whether pBrO2 monitoring~     results in improved outcome after severe TBI, use of this technology has not so far been~     widely adopted in neurosurgical intensive care units (ICUs). This study is the first~     randomized, controlled clinical trial of pBrO2 monitoring, and is designed to obtain data~     required for a definitive phase III study, such as efficacy of physiologic maneuvers aimed at~     treating pBrO2, and feasibility of standardizing a complex intensive care unit management~     protocol across multiple clinical sites.~      Patients with severe TBI will be monitored with Intracranial pressure monitoring (ICP) and~     pBrO2 monitoring, and will be randomized to therapy based on ICP along (control group) or~     therapy based on ICP in addition to pBrO2 values (treatment group). 182 participants will be~     enrolled at four clinical sites, the University of Texas Southwestern Medical Center/Parkland~     Memorial Hospital, the University of Washington/Harborview Medical Center, the University of~     Miami/Jackson Memorial Hospital, and the University of Pennsylvania/Hospital of the~     University of Pennsylvania. Functional outcome will be assessed at 6-months after injury.~   "
197781|NCT00974246|"~     The purpose of this study is to assess the effect of treatment with Advair Diskus on~     depression using the Cornell depression scale in COPD patients in the nursing home.~   "
197782|NCT00974233|"~     The purpose of this research is to evaluate a new combination of chemotherapy drugs for~     CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an~     intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).~      The purpose of this study is to see if giving the chemotherapy pill lenalidomide after~     treatment with bendamustine and rituximab is able to prolong the period of time before the~     cancer starts growing again and causing symptoms.~   "
197783|NCT00974220|"~     Breathing discomfort (dyspnea) and activity limitation are dominant symptoms of chronic~     obstructive pulmonary disease (COPD) and contribute to poor health-related quality of life in~     this population. Several small, uncontrolled studies and published case reports have provided~     evidence that inhaled fentanyl, a powerful pain relieving (opioid) medication, may be used to~     effectively reduce breathing discomfort in patients with advanced disease. However, the~     mechanisms of this improvement remain unclear. Therefore, the investigators plan to conduct~     the first randomized, double-blind, placebo-controlled, crossover study designed to explore~     the possible mechanisms of action of inhaled fentanyl on activity-related dyspnea and~     exercise performance in patients with advanced COPD.~   "
197784|NCT00974194|"~     Many feasibility studies have been published on Single Port surgery, but no comparative~     studies have shown any advantages compared to standard laparoscopy. The purpose of this study~     is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies~     using single port transumbilical approach and three trocars.~   "
197785|NCT00974181|"~     Two consecutive cohorts of subjects were each treated with the CoStar stent loaded with a~     different paclitaxel dose regimen. The first 145 subjects (Arm I), enrolled between 20~     January 2004 and 26 May 2004, were treated with 10 µg paclitaxel and the subsequent 137~     subjects (Arm II), enrolled between 15 December 2004 and 9 March 2005, were treated with 30~     µg paclitaxel. Both dose formulations eluted over 30 days (in-vitro).~      Subjects in both arms completed clinical follow-up at 1, 6 and 12 months post-index~     procedure, with angiographic follow-up at 6 months as outlined in the original study~     protocol.~      Based on results from previous studies and the initial EuroSTAR Trial results, Conor~     Medsystems decided to pursue the dosage used in Arm I, 10 μg/30 days, as the commercial dose~     formulation for the CoStar® stent. The EuroSTAR Trial addendum was proposed for the purpose~     of evaluating the long-term clinical outcomes of the CoStar stent.~   "
197786|NCT00974168|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy~     may be effective in treating malignant spinal cord compression in patients who have received~     previous radiation therapy to the spine.~      PURPOSE: This phase II trial is studying radiation therapy in treating patients with~     malignant spinal cord compression.~   "
197787|NCT00974155|"~     The EMC trial investigates for the first time prospectively whether Major Depression Disorder~     patients with non-improvement after 14 days of antidepressive treatment with EMC are more~     likely to become remitters compared to patients treated according to current guidelines,~     i.e., with a medication change after 28 days of treatment in case of non-response.~   "
197788|NCT00974142|"~     This is a randomized, double-blinded, placebo-controlled trial of oral Cyclosporine A (CsA)~     in patients with advanced stage chronic obstructive pulmonary disease. The purpose of the~     study is to evaluate the safety and effectiveness of CsA as a therapy for the adaptive immune~     response in advanced stage Chronic Obstructive Pulmonary Disease (COPD).~      Subjects between 45 and 80 years of age with a confirmed diagnosis of advanced stage COPD,~     not responsive to conventional inhaler therapy, who meet all the study requirements, will be~     enrolled in this study. A total of 30 subjects of either sex will be enrolled in this study.~   "
197789|NCT00974129|"~     The purpose of this study is to evaluate the genotype of CTCF, a proven transcription factor,~     in patients with infantile hemangiomas and to monitor tumor growth. The investigators aim to~     determine whether or not the CTCF genotype might serve as an early and reliable predictor of~     tumor growth.~   "
197803|NCT00973947|"~     RATIONALE: Using a customized headrest to hold patients in one position may help doctors plan~     treatment for patients with head and neck cancer. It is not yet known whether a customized~     headrest is more effective than a standard headrest in holding patients still during~     radiation therapy.~      PURPOSE: This randomized clinical trial is studying a customized headrest to see how well it~     works compared with a standard headrest in holding patients still while undergoing radiation~     therapy for head and neck cancer.~   "
197790|NCT00974116|"~     The number of children who are obese in the UK is steadily increasing with both short and~     long term consequences for health. The aim of this study is to determine whether the MEND~     Programme (a new national initiative for the treatment of childhood obesity) is a successful~     and sustainable treatment for childhood obesity and obesity related health problems.~      300 overweight and obese children will be randomly assigned to start immediately on the MEND~     Programme for 6 months or join a waiting-list control group for 6 months. Measurements of~     health outcomes will be taken at baseline, and at 6, 12 and 24 months after the Programme.~     After 6 months of waiting-list time, the control group will follow the same protocol as the~     immediate starters. The researchers will be unaware (blinded) to which group each child has~     been assigned to. The study will examine the effects of the MEND Programme on body~     composition, cardiovascular health and psychological health.~   "
197791|NCT00974103|"~     The purpose of this study is to identify how many females have persistent low back pain~     and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can~     continue in the study and be examined by a chiropractor. They will then divide the females~     into Hanne Alberts 5 subgroups of pelvic pain. The females that have one-sided pelvic pain~     will be invited to participate in a randomised controlled study where chiropractic~     intervention is compared to exercises.~   "
197792|NCT00974090|"~     The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in~     combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration~     and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an~     extension treatment for up to 52 weeks.~   "
197793|NCT00974077|"~     The study investigates cognitive attention, rumination and psychophysiological (EEG)~     processes in healthy subjects and remitted patients with at least three previous depressive~     episodes. The investigators expect that Mindfulness Based Cognitive Therapy prevents future~     depressive episodes and has influence on cognitive and psychophysiological measures.~   "
197794|NCT00974064|"~     Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD,~     commonly known as chronic bronchitis and emphysema). Despite this clear link, only 15-20% of~     smokers develop COPD suggesting that genetic factors affect the lung's susceptibility to the~     stress of cigarette smoke. The cells lining the airways (epithelium) and cells that help~     defend the lung (alveolar macrophages) of smokers develop gene expression changes that are~     different from that of nonsmokers. In the investigators' previous studies they have~     demonstrated that there are greater than 200 genes that are responsive to cigarette smoke in~     these cells. But the investigators do not know whether the gene expression is static or~     changes as a function of time. Genes that show significant changes over time may be relevant~     to the progression of the disease. Even though quitting smoking reduces the rate at which the~     lungs decline, many-smokers still go on to develop COPD. This study will provide insights~     into the natural history of smoking-related gene expression of the lung cells in health and~     disease.~   "
197795|NCT00974051|"~     The investigators hypothesize that the use of an oral dose of Terbutaline or a 20% basal~     reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session.~     This is a randomized three period cross-over study including treatment with Terbutaline, a~     20% basal reduction for six hours, or no treatment (control).~   "
197796|NCT00974038|"~     We are interested in studying two different psychological treatments for eating disorders for~     adolescents (ages 12-18). The study is designed to help adolescents who are having problems~     with binge eating and/or purging. The treatment consists of 14 sessions of approximately~     one-hour each over about three months.~   "
197797|NCT00974025|"~     In this study, investigators will evaluate the effect of vitamin C on endothelial function,~     exercise tolerance and quality of life in patients with a single ventricle who have been~     palliated to Fontan physiology. The hypothesis is that vitamin C will result in improved~     exercise tolerance and endothelial function in patients who have undergone the Fontan~     operation, compared to placebo.~   "
197798|NCT00974012|"~     This study was designed to compare the relative bioavailability (rate and extent of~     absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg~     following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy,~     adult subjects under non-fasting conditions.~   "
197799|NCT00973999|"~     TITLE~      A randomised placebo controlled trial to explore the effectiveness of Botulinum Toxin~     injection at reducing oral secretions and frequency of tracheal suctioning in tracheotomised~     patients.~      DESIGN~      Randomised controlled single blinded experimental design~      AIMS~      The purpose of this study is to determine if ultra-sounded guided injections of Botulinum~     Toxin into the salivary glands (Parotid and sub-mandibular glands) of patients with a~     tracheostomy tube in-situ assists in the reduction of oral secretions.~      OUTCOME MEASURES~      Amount of saliva production / frequency of tracheal suctioning / questionnaires.~      POPULATION~      In-patients at the Wellington Hospital based in London will be invited to participate within~     the study. Participants will be recruited from a range of wards which will include the~     Intensive Treatment Unit (ITU), acute medical wards and rehabilitation wards. All~     participants will have a tracheostomy tube in-situ and be breathing on room air, without the~     need for any mechanical ventilation. Participants will be receiving tracheal suctioning to~     assist in the clearance of saliva to maintain a clear airway.~      A total of 40 participants will be recruited to the study across a two year period.~      Each participant will have no prior history of the following:~        -  swallowing disorders~        -  stroke~        -  myocardial infarction~        -  head or neck surgery~        -  respiratory disease~        -  acute or progressive neurological disease~        -  structural abnormalities that could affect swallowing~        -  other medical conditions requiring medication that could affect swallowing.~      ELIGIBILITY~      Male and female adults over the age of 18 years~      TREATMENT~      Injection of Botulinum Toxin into both pairs of the parotid salivary glands and submandibular~     glands, using ultrasound guidance~      DURATION~      Data collection over a two year period / six weeks for each participant~   "
197800|NCT00973986|"~     The aim of the study is to investigate the effects of CYP3A polymorphisms on the~     pharmacokinetics of Atorvastatin in Chinese subjects with coronary heart disease.~   "
197801|NCT00973973|"~     The purpose of this study is to evaluate NBI-56418 compared to placebo (also known as a sugar~     pill) for its effects on endometriosis related pelvic pain and its safety.~   "
197802|NCT00973960|"~     The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier~     Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes.~      The primary efficacy endpoint is an assessment of glycemic control at week 24 or last~     assessment measured via HbA1c.~   "
197804|NCT00973934|"~     This two-center, between-subject, randomized, double-masked study (n=20) will provide the~     first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast~     the therapeutic properties and side effects of two forms of MST in patients in a major~     depressive episode (MDE).~   "
197805|NCT00973921|"~     The primary objective of this study is to determine the diagnostic efficiency and accuracy of~     using the StentOptimizer. The ability of StentOptimizer to influence post deployment~     treatment strategy will be assessed and compared to the IVUS system. In addition, the~     correlation of diameter measurements between the StentOptimizer, IVUS and 2D QCA will be~     assessed. The StentOptimizer software, IVUS and 2D QCA were all part of the clinical~     procedure outside the study. The analysis of post deployment treatment decisions and diameter~     measurements using those modalities retrospectively make this an observational study.~   "
197806|NCT00973908|"~     The investigators aim to investigate whether the routine use of the probiotic formulation~     VSL#3 co-prescribed with antibiotics reduces the incidence of both Antibiotic associated~     diarrhoea and Clostridium Difficile associated diarrhoea.~   "
197807|NCT00973895|"~     Background:~        -  Vaccines are substances used to try to create resistance (or immunity) to a disease and~          to prevent an infection. Researchers are testing a new DNA vaccine designed for a new~          type of influenza, often referred to as swine flu. The DNA vaccine will instruct the~          body to make a particular kind of influenza protein that the immune system will be able~          to recognize.~        -  Researchers are interested in determining if the vaccine is safe and effective in~          humans, and would like to study the immune system's response to the vaccine. The vaccine~          will not give participants influenza; however, it may not be effective in preventing~          them from getting influenza at a later date.~      Objectives:~        -  To evaluate the safety and tolerability of the VRC-FLUDNA057-00-VP influenza vaccine as~          administered to healthy adults.~        -  To evaluate antibody responses to the new influenza vaccine.~      Eligibility:~      - Healthy adults between the ages of 18 and 70.~      Design:~        -  Participants will have seven planned clinic visits during this study (enrollment day and~          study weeks 1, 4, 8, 9, 12, and 32).~        -  All participants will receive three injections of the test vaccine, given as individual~          doses on day 0, day 28, and day 56 of the study. The vaccine will be given in the upper~          arm muscle.~        -  Injections will be given using a needleless system that delivers the vaccine through the~          skin by using the pressure of carbon dioxide to inject the vaccine through the skin and~          into the muscle. Participants will remain at the National Institutes of Health (NIH)~          Clinical Center for at least 30 minutes after the injection to be monitored for any~          reaction.~        -  Participants will be asked to keep a 7-day diary card after each injection to record~          their physical reactions to the vaccine.~        -  Participants will be asked to return to the NIH Clinical Center as requested by~          researchers for additional blood tests and other procedures, as required by the study.~   "
197808|NCT00973882|"~     The aim of our study is to assess the efficacy and toxicity of a chemotherapy regimen~     combining carboplatin and etoposide in patients with metastatic hormone-resistant prostate~     cancer and neuro-endocrine differentiation. Eligible patients are treated with the~     combination of carboplatin AUC4 on day 1 and etoposide 100 mg/m2 on day 1, day 2 and day 3~     repeated every 3 weeks for a maximum of 6 cycles. Efficacy endpoints include Prostate~     Specific Antigen (PSA) and neuro-endocrine marker response (defined as a 50% or greater~     decrease from baseline serum values), objective response rate (according to RECIST criteria),~     and toxicity.~   "
197809|NCT00973869|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of curcumin may prevent or treat colorectal cancer.~      PURPOSE: This phase I trial is studying the side effects of curcumin in preventing colorectal~     cancer in patients undergoing colorectal endoscopy or colorectal surgery.~   "
197810|NCT00973856|"~     The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to~     treat warts located on the hands.~   "
197811|NCT00973830|"~     Objective: to evaluate the efficacy of the American College of Physicians Foundation (ACPF)~     Diabetes Guide (Living with Diabetes: An Everyday Guide for You and Your Family) to improve~     diabetes self-management.~      Study Sites: Nine Federally-qualified health centers or safety-net clinics at three sites in~     Missouri. Sites are urban (St. Louis), midsize (Columbia) and rural (Kirksville). Three FQHCs~     or safety net clinics are located at each of the sites.~      Methods Overview and Design: A randomized controlled trial will be conducted. Patients will~     be recruited from identified health centers. As the intervention itself is directed to the~     clinic and not patient, the clinics will be randomly assigned to either 1) usual care (no~     treatment), 2) Carve-In - patients receive the Diabetes Guide and clinic staff follow-up~     and work with patients to create and complete action plans or 3)Carve-Out - patients~     receive the Diabetes Guide and a diabetes educator in Chicago follows up and works with~     patients to create and complete action plans. Recruited subjects will be administered a~     baseline assessment, and 3-month and 1-year follow-up assessments.~      Sample: The investigators will recruit a total of 1,080 patients (n=120 per clinic)~     anticipating 80 percent retention through both follow-up assessments (final estimated number~     of patients = 720). Eligibility to participate will be defined as patients 1) ages 30 and~     older (to better represent disease distribution), 2) English or Spanish-speaking, 3) a~     confirmed (by chart) diagnosis of uncontrolled diabetes (HBA1c 7.0 or more).~   "
197812|NCT00973817|"~     The purpose of this study is to investigate the safety and efficacy of the use of ELAD in~     patients with diagnosed Acute On Chronic Hepatitis, including Acute Alcoholic Hepatitis.~   "
197813|NCT00973804|"~     Background:~        -  Allogeneic stem cell transplantation (SCT) has been used to treat many kinds of cancer~          or pre-cancerous conditions that develop in blood or immune system cells. Umbilical cord~          blood transplantation (UCBT) is a type of allogeneic transplant that is used when none~          of a patient s siblings are a match and an acceptable match cannot be identified from~          one of the bone marrow registries. Prior to receiving the cord blood stem cells, large~          doses of chemotherapy drugs and/or radiation have been traditionally used to eliminate~          most of the cancerous or abnormal cells from the recipient s system, along with most of~          his or her own stem cells and immune cells. Donor stem cells then replace the recipient~          s stem cells in the bone marrow, restoring normal blood production and immunity. In this~          way, an allogeneic SCT provides not only new blood cells but an entire new immune~          system.~        -  In the past, allogeneic SCT was performed with very high doses of chemotherapy and/or~          radiation to get rid of as much of the recipient s cancer as possible and prevent~          rejection of the treatment. However, intensive chemotherapy or radiation can cause~          serious side effects, including death. A newer method uses smaller, less toxic doses of~          chemotherapy and/or radiation before allogeneic SCT. In these reduced-intensity stem~          cell transplants, the recipient s stem cells and immunity are not completely eliminated,~          but they are weakened enough to help prevent the donor s cells from being rejected.~      Objectives:~      - To study the safety and effectiveness of reduced-intensity stem cell transplants given with~     immune-depleting chemotherapy and umbilical cord blood provided by an unrelated donor.~      Eligibility:~        -  Individuals between 18 and 69 years of age who have been diagnosed with any of a number~          of cancerous and pre-cancerous blood conditions, including lymphoma and leukemia.~        -  Participants must not have a potential donor sibling or a readily available unrelated~          donor identified through one of the bone marrow donor registries.~      Design:~        -  Patients will be matched with at least two umbilical cords with an acceptable cell dose.~          The two frozen umbilical cord blood units will be sent to the NIH prior to the date of~          transplant.~        -  Patients will receive one, two, or three cycles of chemotherapy (based on the type of~          disease) to treat the disease and to weaken the immune system. Patients who already have~          a weakened immune system from other treatments will not receive this round of~          chemotherapy.~        -  Patients will then receive 4 days of reduced-intensity transplant chemotherapy (also~          called the conditioning regimen ) to prepare for the transplant.~        -  Two days after transplant chemotherapy, patients will receive the transplant, with the~          two umbilical cords infused one after the other on the same day. Patients will receive~          additional treatment to prevent complications.~        -  Patients will remain in the hospital for 4 to 6 weeks after the transplant, and will be~          discharged for outpatient treatment when the study doctors deem it appropriate.~        -  Patients will continue on medications at home to lower the risk of complications and~          infections, and will visit the NIH clinic regularly for the first 6 months after the~          transplant, and then less often for at least 5 years afterward.~   "
197953|NCT00971971|"~     Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of~     this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and~     ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI)~     patients submitted to sustained low-efficiency dialysis (SLED).~   "
197954|NCT00971958|"~     Background: Novel HIV prevention approaches are urgently needed in Botswana and elsewhere in~     sub-Saharan Africa. Although adult male circumcision (MC) has been shown to reduce the~     heterosexual acquisition of HIV by men by about 60%, MC in infancy is optimal for its~     relative ease, lower cost and low rate of complications. We have conducted focus groups and~     semi-structured interviews that suggest neonatal MC (< 28 days of life) would be an~     acceptable public HIV prevention strategy in Botswana. The government of Botswana is~     committed to scaling up MC services in the immediate future and they plan to include~     neonates. Understanding decision-making around infant MC will be essential to maximize the~     effectiveness of this HIV prevention strategy.~      Specific Aims: The investigators propose to: 1) determine the acceptability and actual uptake~     of neonatal MC in southeastern Botswana and identify barriers to uptake; 2) ascertain the~     feasibility and safety of neonatal MC in Botswana; 3) Estimate what, if any, advantages would~     exist for scale up of Mogen Clamp, Plastibell or AccuCirc with regard to human resources,~     equipment needs, adverse events and acceptability to health-care providers and families in~     Botswana.~      Study Design and Schema: The investigators will conduct structured interviews with early~     postpartum mothers and fathers to determine correlates of neonatal MC acceptability and~     uptake, defined as neonatal MC following informed consent. Male infants will be circumcised~     by a trained doctor in a hospital / clinic setting by one of three FDA-approved devices that~     are currently in use in US hospitals: Mogen clamp, Plastibell or AccuCirc. Circumcision with~     Mogen Clamp or Plastibell will be done before 29 days of life. Circumcision with AccuCirc~     will be done before 11 days of life (FDA approval limit for device). The investigators will~     also administer questionnaires to the parents at the regular pediatric follow-up visit(s) to~     assess impressions of / satisfaction with the infant's procedure outcome over time. Provider~     impressions of the three methods will also be evaluated. Sample size will be 150 infants per~     arm for a total of 450 infants males circumcised (and an estimated 800 parental~     questionnaires).~      Public Health Significance: The World Health Organization (WHO) and UNAIDS state that~     countries with severe, generalized HIV epidemics but low rates of MC should offer this~     surgery as an important, evidence-based HIV prevention intervention, including among~     neonates. These two agencies also recommended that additional research on the most feasible,~     safe, and sustainable ways of scaling up MC intervention should be performed. This study will~     be in keeping with these recommendations.~      Please note the Mogen clamp and Plastibell study arms began as a randomized trial before the~     initiation of the AccuCirc single-arm portion. Although the settings in which the three~     devices were studied were similar, the AccuCirc trial enrollment began at two sites (Gaborone~     and Molepolole) only after completion of the Mogen clamp and Plastibell arms, which was~     conducted in three sites (Gaborone, Molepolole and Mochudi). Although Lobatse was a site for~     the first acceptability study with mothers, no procedures were performed there.~      Regarding the reported sample size: the total, final sample size includes both parents of~     newborn boys (because enrolled consenting parents completed questionnaires as part of this~     study), and boys whose parents consented to circumcision. We anticipated that not all parents~     who completed the questionnaire would consent to circumcising their baby; therefore, when~     planning the study it was necessary to estimate the number of parents who would participate~     in the survey (700), to achieve an enrollment of 300 neonates (therefore the initial estimate~     of 1000). The original study in fact enrolled 302 infants, 600 mothers and 19 fathers (total~     study population 921). The addition of the AccuCirc arm led to a revised estimate of total~     number of neonates and their parents (total=1250). The final enrollment was of 1,235~     participants, that includes all the participating neonates and parents.~   "
197814|NCT00973791|"~     Fluid management plays an essential role in cesarean section. In previous study (NCT00488111)~     the investigators found that prior-epidural anesthesia fluid management produced a more~     significant role in stabilizing the blood pressure and better prognosis after cesarean~     delivery than that of the posterior-anesthesia ones. Given epidural anesthesia has a time~     interval before reaching the best state of anesthesia, so the fluid management also has a~     relatively adequate time to resuscitation. In reality, spinal anesthesia is used popularly~     except for the epidural anesthesia, whereas spinal anesthesia would produce more significant~     fluctuation of the hemodynamics compared with the latter. Herein the investigators proposed~     whether the prior-spinal anesthesia fluid management also produced similar effect on~     hemodynamic characteristics to the epidural anesthesia.~   "
197815|NCT00973778|"~     Intensity modulated radiotherapy (IMRT)-based radiation therapy that delivers a high dose of~     radiation directly to the tumor may kill more tumor cells and cause less damage to normal~     tissue. Investigators initiated a prospective study to evaluate the efficacy and toxicity of~     short course preoperative chemoradiotherapy utilizing Intensity Modulated Radiation Therapy~     (IMRT) in combination with capecitabine in patients with resectable rectal carcinoma.~   "
197816|NCT00973765|"~     Patients will be enrolled in a multi-center study to prospectively evaluate outcome after~     treatment for an uncomplicated skin abscess. All patients will receive incision and drainage~     and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7~     days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the~     emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary~     outcome is treatment failure rates at 7 days after incision and drainage. Patients who are~     clinically worsening or not improving after 48 hours will then be treated with additional~     antibiotics or admission if needed. Data will be analyzed both by initial randomization and~     intention to treat.~   "
197817|NCT00973752|"~     The purpose of this study is to determine the safety and effectiveness of a multi-drug~     regimen (which includes prednisone, vincristine, cytarabine, doxorubicin, 6 mercaptopurine,~     and methotrexate) which is considered standard treatment for children and young adults with~     acute lymphoblastic leukemia (ALL), in combination with PEG-asparaginase and clofarabine to~     treat older adults with ALL. PEG-asparaginase has been used in chemotherapy treatment~     regimens for both children and adults with ALL. Clofarabine has been used in chemotherapy~     treatment regimens for children with ALL and has been shown to decrease the number of~     leukemia cells. Participants with leukemia that has an abnormal chromosome, called the~     Philadelphia chromosome, will also be given imatinib.~   "
197818|NCT00973739|"~     The purpose of this study is to determine if Lapatinib has any effect on tumors found in~     patients with Neurofibromatosis Type 2 (NF2). NF2 is a condition that mainly affects the skin~     and nervous system. It causes non-cancerous tumors (which are known as neuromas) to grow on~     the nerves around a person's body. Some signs of NF2 include a gradual loss of hearing and~     tumors growing on the skin, the brain and the spinal cord which can lead to complications.~      Lapatinib is an oral drug that is approved by Food and Drug Administration (FDA) for other~     types of tumors, it is not approved by the FDA for treatment of NF2 related tumors. The~     investigators know a lot about how well it is tolerated, but the investigators do not know if~     it is effective in treating your condition, therefore it is considered to be an~     investigational medication. This study will test whether Lapatinib may shrink tumors commonly~     found in patients with NF2 or stop them from growing. This will help us to decide if~     Lapatinib should be used to treat NF2 patients in future. Lapatinib is a drug that has been~     used for over 10 years to treat various forms of cancer. It has not been studied for the~     treatment of tumors in NF2 patients.~   "
197819|NCT00973726|"~     This project has the following specific purposes:~        -  To develop a clinically usable test to determine the blood glucose level or HbA1c-level,~          to which the retina is adapted. This will be performed by means of ERG implicit time~          measurements in relation to the blood glucose level during an oral glucose tolerance~          test (OGTT) and inter- or extrapolation to the level of blood glucose (or HbA1c) where~          implicit time is normal.~        -  To examine darkadaptation in diabetics in relation to changes in the glucose level.~        -  To examine vessel diameter changes in diabetic individuals when changing the glucose~          level transiently~   "
197820|NCT00973713|"~     This is a clinical trial investigating the effectiveness and safety of the study drug RAD001~     in patients with advanced (metastatic) cholangiocarcinoma. Palliative chemotherapy provides~     some benefit to this group of patients. However, chemotherapy treatment only shows low rates~     of radiological response and short times to tumour progression. Therefore, further treatment~     options are urgently required.~      In laboratory studies, RAD001 has been shown to interrupt the signals that cancer cells use~     to grow, spread and form new blood vessels (angiogenesis). RAD001 has been approved for the~     treatment of kidney cancer. It has also been approved for use in Australia for the treatment~     of patients with kidney and liver transplants, and has been used in thousands of patients~     worldwide for this indication. Preliminary studies suggest that RAD001 may have activity in a~     range of other cancers. This study will evaluate the activity of RAD001 in advanced~     cholangiocarcinoma.~   "
197821|NCT00973700|"~     This study will evaluate the safety and immunogenicity of different combinations of A/H1N1~     S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.~   "
197822|NCT00973687|"~     The purpose of this study is to assess whether smaller volumes of oral dexamethasone result~     in better tolerability, specifically less vomiting, in pediatric patients during an acute~     asthma exacerbation.~   "
197843|NCT00973414|"~     Regional anesthesia, including epidural, spinal and combined epidural spinal anesthesia~     (CSEA), is a pivotal part in modern anesthesiology. Previously, the investigators found that~     epidural and spinal anesthesia during cesarean section possesses different responsiveness to~     fluid (including crystalloid and colloid) management given prior or posterior to anesthesia.~     Although CSEA is also widely used as an alternative of single epidural or spinal anesthesia~     for its combined effect of fast onset of anesthesia of spinal anesthesia and the property of~     duration of epidural catheterization, the fluid resuscitation during CSEA is still unknown.~     The investigators hypothesized that fluid management during CSEA would produce different~     effect on hemodynamics in cesarean section compared with epidural and spinal anesthesia.~   "
197823|NCT00973674|"~     Each year in the United States alone, a third of a million persons are hospitalized for~     traumatic brain injury (TBI), of whom approximately 1/4 die. Most are less than 30 years of~     age. Not only are the health care costs staggering for both initial care and rehabilitation,~     but the societal loss in terms of economic impact reaches into the billions of dollars~     annually in the U.S. alone. Despite advances in neurosurgical interventions and intensive~     care management, many survivors do not fully recover. A significant cause of this mortality~     and morbidity is thought due to potentially preventable secondary injury, namely oxidant~     injury, inflammation, and apoptosis in the penumbra (the area of brain surrounding the~     primary lesion, which is at-risk, but potentially salvageable), beginning in the first few~     hours after the severe traumatic event.~      Despite the current bleak outlook for many of these patients, a series of animal~     investigations have uncovered a promising solution to the problem of the secondary injury~     seen in severe TBI and other similar processes, namely the early administration of estrogen,~     a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound. Based on these~     encouraging results from animal studies, the investigators hypothesize that early~     administration of IV Premarin® in patients with severe TBI will safely reduce secondary brain~     injury, improve neurological outcomes, and improve survival.~   "
197824|NCT00973661|"~     The purpose of this study is to design and assess the impact of an electronic alert and tool~     set to assist with physician identification and counseling of overweight patients.~   "
197825|NCT00973648|"~     This pilot study aims to increase the understanding of tinnitus through the identification of~     potentially altered brain networks in patients who are able to voluntarily control or alter~     their tinnitus. Upon completion of this study, new knowledge will be gained about the changes~     in brain activity in people who are able to modify their tinnitus.~   "
197826|NCT00973635|"~     A handoff is defined as the transfer of role and responsibility from one person to another in~     a physical or mental process. Current evidence shows that handoffs between medical providers~     are both common, and fraught with potential for harm. In spite of these problems, handoff~     skills are rarely discussed or practiced. Currently, there are few curricula available in the~     literature regarding the teaching of handoff skills. The purpose of the investigators' study~     is to develop a curriculum focusing on key handoff safety issues. The investigators plan to~     create an independent learning tutorial that would be easily administered to all beginning~     interns (medical subinterns and 2nd month pgy1 medical interns), that would be accessible~     across multiple sites, that would increase learner knowledge regarding key handoff safety~     issues, and would improve trainee satisfaction with the handoff process. The investigators'~     goal is to make this curriculum practical and time efficient. The investigators' hope is that~     the educational intervention would also have a measurable impact on the quality of patient~     care.~   "
197827|NCT00973622|"~     This study will examine the effects of high frequency, repetitive Transcranial Magnetic~     Stimulation (rTMS) on decision-making and smoking behavior.~   "
197828|NCT00973609|"~     Investigating the efficacy of maintenance and reinduction treatment or no treatment and~     watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic~     colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-,~     oxaliplatin- and bevacizumab-based chemotherapy.~      The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be~     compared with a maintenance treatment with bevacizumab alone or no maintenance treatment.~     Reinduction treatment will be done in case of progression.~   "
197829|NCT00973596|"~     The purpose of this prospective multicenter cohort study is to examine long-term medical~     outcomes, quality of life, and medical resource utilization in elderly patients (>= 65 years)~     with acute venous thromboembolism (i.e., acute pulmonary embolism and/or deep vein~     thrombosis)~   "
197830|NCT00973583|"~     The investigators earlier clinical study in 754 young Finnish men demonstrated a significant~     negative association of serum 25-OHD concentration with acute respiratory tract infections.~     The present study aimed to determine whether vitamin D supplementation may decrease the~     incidence of acute respiratory tract infections.~   "
197831|NCT00973570|"~     Background: Most of the efforts to fight against young people's tobacco addiction have~     focused on smoking prevention and little on smoking cessation. A smoking cessation program,~     associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable~     population (vocational trainees), was developed by a team of tobacco addiction specialist~     physicians. We developed a study to evaluate the efficacy of the program. Its main objective~     is to compare the efficacy of a smoking cessation program offered to all smokers in a~     population aged 15 to 20 years in Vocational Training Centers (VTC) with that in a control~     population. The objective of this paper is to present the TABADO study protocol and the~     results of the pilot study.~      Methods: The study is quasi-experimental, prospective, evaluative and comparative and takes~     place during the 2 years of vocational training. The final population will be composed of~     2000 trainees entering a VTC (in Lorraine, France): The intervention group (1000 trainees)~     benefited from the TABADO program while no specific intervention took place in the control~     group (1000 trainees) other than the treatment and education services usually available. Our~     primary outcome will be the tobacco abstinence rate at 12 months.~      The pilot study is a descriptive monocentric cross-sectional study conducted among the whole~     group of students, completed by a longitudinal prospective study of smoker volunteers.~   "
197844|NCT00973401|"~     The purpose of this study is to measure the amplitude and implicit time of electroretinogram~     (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical~     treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months.~     Newly diagnosed type 1 and type 2 diabetics as well as dysregulated type 1 and type 2~     diabetic individuals will be included. Retinal vessel calibre measurements will be used as an~     estimation of changes in the retinal perfusion.~   "
197845|NCT00973388|"~     The purpose of this study is to evaluate the effect of telaprevir on the results of~     electrocardiograms in healthy volunteers. An electrocardiogram is an electric recording of~     the heart. Telaprevir is being investigated for the treatment of chronic hepatitis C virus~     infection.~   "
197846|NCT00973375|"~     The purpose of this study is to investigate if there is any different follow-up results by~     angiography and IVUS between two different drug-eluting stents after implanted simultaneously~     in same individuals.~   "
197832|NCT00973557|"~     The purpose of this research is to determine whether the drug, Bevacizumab (a monoclonal anti~     VEGF-A antibody), which is approved to treat patients with metastatic colon cancer induces~     hyperprolactinemia (increased prolactin secretion) in humans with intact pituitary function.~     Past studies have shown Bevacizumab to shrink tumor size and also increase prolactin levels.~     The mechanism of the hyperprolactinemia might be inhibition of pituitary portal vein~     transport, suggesting that Bevacizumab induces prolactin secretion from normal lactotrophs in~     the pituitary gland.~      Patients who have been treated with Bevacizumab for at least one month will be recruited to~     participate.~      The subjects who are being treated with Bevacizumab by Dr. Stephen Wolin (a sub-investigator)~     will be screened by him for study eligibility. Dr. Wolin will approach eligible patients with~     all the information and background of the study and see if they have an interest in being~     consented.~      If consented, there will be 2 blood draws for the research that is not part of their standard~     care in which 10 ml of blood is collected and prolactin, growth hormone, IGF-I, TSH,~     thyroxine, ACTH, and cortisol will be measured. One 5ml blood draw will occur before the~     administration of Bevacizumab and the second 5 ml blood draw will occur after the~     administration of the Bevacizumab. The investigators will then review the laboratory results.~     The blood tests are of the hormones of the pituitary gland to test pituitary function and see~     if there are any abnormalities with the secretions of the gland. Pituitary function~     abnormalities and hyperprolactinemia are diagnosed by looking at hormone levels in the blood~     and comparing them to the normal reference ranges.~      This study will only involve 10 subjects and will be conducted entirely at Cedars-Sinai~     Medical Center.~   "
197833|NCT00973544|"~     The purpose of this study is to describe the relations between closed suction drains~     placement in breast reconstructions procedures with silicone prothesis to the development of~     local wound complications (seroma, hematoma, infections).~   "
197834|NCT00973531|"~     The investigators would like to investigate the effects of treating sleep apnea with a~     positive airway pressure device, either continuous (titrated) versus auto titrated on the~     control of blood pressure in patients with Resistant Hypertension.~   "
197835|NCT00973518|"~     The current study is intended to enrich and extend the database of Alzheimer's Disease (AD)~     and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for~     dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of~     normal neurological function. This study will include 2 MEG and electroencephalography (EEG)~     scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All~     subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day~     of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects~     will undergo 2 standard functional tests.~      This study will test the following hypotheses:~        -  MEG scans of resting-state, eyes-open brain function reveal patterns of correlated~          activity that differ between HC subjects and subjects diagnosed with dementia of~          Alzheimer's type;~        -  Patterns of correlated activity measured in AD subjects correspond to other measures of~          disease severity such as standard functional test scores;~        -  MEG scan patterns for HC subjects are consistent across repeated measures taken over a~          30 day period.~   "
197836|NCT00973505|"~     The purpose of this study is to investigate the relationship between the side~     effects(especially arthralgia and arthritis) which appear in the patients who are prescribed~     aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.~   "
197837|NCT00973492|"~     The primary objective of this trial is to assess whether functional insulinotherapy decreases~     blood glucose variability at 3 months and 6 months, compared to initial values in type 1~     diabetes patients.~      So, this study measures the impact of functional insulinotherapy on several blood glucose~     variability indicators in patients with type 1 diabetes.~      This trial also has a secondary objective: to measure the effect of functional~     insulinotherapy on oxidative stress and inflammation.~   "
197838|NCT00973479|"~     The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with~     methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.~   "
197839|NCT00973466|"~     There has been an increase in incidence in sexually transmitted infections in HIV infected~     patients in the last years. In this study the investigators will prospectively evaluate the~     prevalence of symptomatic and asymptomatic infections with N. gonorrhea and Ch. trachomatis~     as well as the seroprevalence of Herpes simplex Type 2 infection in HIV-infected patients~     attending the clinic for infectious diseases at the Berne University Hospital. In addition,~     participants will be asked to fill out a questionnaire on sexual behaviour and sexual health.~      Study hypothesis: STI prevalence is high in certain risk-groups to justify screening in~     regular intervals.~   "
197840|NCT00973453|"~     The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is~     achieved by 90% of the patients with less than 20% of the injections giving rise to a~     swelling of > 5 cm and the optimal regimen to reach this maximum dose will be determined.~   "
197841|NCT00973440|"~     Older individuals account for one-third of new cancer cases and cancer-related deaths in the~     United States. Older individuals are more susceptible to having a decrease in physical and~     mental function following chemotherapy treatment. Geriatric assessment may provide a way to~     identify those older individuals at greatest risk of functional decline before treatment~     starts and during the period of treatment. Geriatric assessment includes a set of screening~     questions and tests designed to determine the physical and mental status of the individual at~     a point in time. Geriatric assessment also includes review of medications and other medical~     conditions the individual may have that may affect function. The investigators are conducting~     this study to determine if older individuals are able to complete the geriatric assessment~     using a computer format and how that corresponds to their treating physician's assessment of~     their functional status before and after starting a new chemotherapy treatment for colon,~     rectal, breast or lung cancer. The investigators will also evaluate the usefulness of a~     computerized form of geriatric assessment.~   "
197842|NCT00973427|"~     The purpose of the study is to determine whether a DNA chip, designed by Medical Prognosis~     Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous~     and large cell lung cancer).~   "
197847|NCT00973362|"~     The purpose of this study is to provide data on the performance of the APTIMA HPV Assay using~     the TIGRIS System in detecting HPV types that may cause cervical cancer.~   "
197849|NCT00973336|"~     Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium~     efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again~     which may result in secondary hyperparathyroidism or even hungry bone syndrome. Until today~     there are no studies about this problem helping to develop recommendations or guidelines how~     to prevent these symptoms.~      Study hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by~     keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents~     hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).~   "
197850|NCT00973323|"~     This study was a randomized, parallel group, open label trial using warfarin as comparator.~     Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups~     (originally described in Japanese).~   "
197851|NCT00973310|"~     The purpose of this study is to determine the safety and efficacy of the concurrent use of~     erlotinib and radiation therapy in the treatment of locally advanced non-small lung cancer.~   "
197852|NCT00973297|"~     Falls are a major complication in patients treated in rehabilitation departments, yet studies~     evaluating different interventions to reduce falls-risk are rare and inconclusive.~      The aim of the present study is to evaluate the efficacy of a multidisciplinary~     fall-prevention program to reduce falls and injury in stroke patients treated in a~     rehabilitation department.~      All stroke patients consecutively admitted to the department of rehabilitation at~     Hadassah-Hebrew University Medical Center for a period of one year will be eligible for~     inclusion. Upon receiving an informed consent subjects will be randomized to the intervention~     group or the control (convention care) group.~      There are no exclusion criteria. The Intervention includes group education on risk of falling~     and safe mobility and transfers; physical therapy of balance training at the patients'~     bedside twice weekly and medical assessment of medication use (anxiolytics/hypnotics,~     neuroleptics, antihypertensives and other vasodilators), orthostatic hypotension, urinary~     frequency/incontinence, delirium and visual problems.~      Intervention therapy will not be given as an extra time, rather at the same treatment time as~     the control group.~      Primary outcomes are rate of falls and related injuries.~   "
197853|NCT00973284|"~     The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle~     (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during~     the inpatient stay.~   "
197854|NCT00973271|"~     The hypothesis of this study is that DCCR is effective as both monotherapy and in combination~     with a statin in lowering triglycerides in subjects with very high triglycerides~   "
197855|NCT00973258|"~     The aims of this proposed community-based randomized controlled trial are to evaluate the~     effectiveness of nutritional, physical exercise and cognitive training interventions for~     at-risk and frail elderly, to elucidate the biological determinants and changes associated~     with frailty, and to develop, evaluate and demonstrate the feasibility of screening~     instruments for frailty.~   "
197856|NCT00973245|"~     This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD)~     effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in~     Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).~   "
197857|NCT00973232|"~     The objectives of this two-part study were to compare the single-dose and multiple-dose~     pharmacokinetics of extended release and immediate-release fixed combination formulations~     containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the~     extended-release formulation.~   "
197858|NCT00973219|"~     Rationale:~      Worldwide, approximately 400 million people are chronically infected with hepatitis B virus~     (HBV). Chronic HBV infection increases the risk of developing cirrhosis, hepatic~     decompensation and hepatocellular carcinoma (HCC). The risk of developing hepatocellular~     carcinoma is highest in HBeAg positive patients with high HBV DNA levels, but still the~     relative risk remains 10 for HBeAg negative patients. Furthermore it has been shown that when~     HBsAg is cleared before cirrhosis has developed, the prognosis is excellent. Recently the~     investigators have shown that HBeAg negative patients with high HBV-DNA load and low baseline~     HBsAg levels had a significantly higher HBsAg clearance (positive predictive value of 85%)~     after combination therapy with peginterferon alfa2a (Peg-IFN) and adefovir.~      Based on these results, a trial was designed to investigate whether combination of a~     nucleos(t)ide analogue combined with PegIFN, could also provoke a high rate of HBsAg~     clearance in chronic hepatitis B patients with low (HBV DNA <20,000 IU/mL) viral load.~      Study design:~      This is a three arm open-label prospective randomized controlled trial. 150 patients will be~     enrolled into the study after assessment of eligibility. All patients must have documented~     HBsAg positivity for longer than 6 months, HBeAg negativity, anti-HBe positivity, HBV DNA <~     20,000 IU/mL and ALT < 5 * upper limit of normal. Patients with a Child Pugh class B or C~     will be excluded. Group 1 will consist of patients treated with Peg-IFN and adefovir, group 2~     will consist of patients treated with Peg-IFN and tenofovir and group 3 will consist of~     untreated controls. Patients in group 1 and 2 will receive medication for the period of one~     year. For enrolment into the study a liverbiopsy at time of enrolment is compulsory and is~     advisable at end of treatment (week 48).~      Study population: The study population will consist of 150 patients chronically infected with~     hepatitis B virus with low viral load and HBeAg negativity.~      Main study parameters/endpoints:~      The aim of this study is to investigate what proportion of HBeAg negative, inactive carriers~     of the hepatitis B virus with low (< 20,000 IU/mL) load will lose HBsAg when treated with~     nucleot(s)ide analogue/Peg-IFN combination therapy.~      In this study the investigators hypothesize that both treatment with peg-interferon and ADF~     or Peg-IFN and TDF in HBeAg negative chronic hepatitis B patients with low HBV DNA viral load~     will induce a high rate of HBsAg loss, comparable to that in patients with high viral load~     after treatment with ADF and Peg-IFN.~   "
197859|NCT00973206|"~     The purpose of this study is to identify risks for cardiovascular events in a follow up~     period of 10 years.~   "
197860|NCT00973193|"~     The purpose of this study is to investigate the activity of panitumumab in combination with~     standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete~     surgery and adjuvant chemotherapy.~      The main hypothesis of the study is that the association of EGFR-targeting agent and~     radiation therapy could be as effective or even improve the rate of pathological complete~     tumoral response with fewer toxicities in comparison to the standard of care using~     chemoradiation therapy.~   "
197875|NCT00972998|"~     This is an open label, dose-finding study. Approximately 8 healthy subjects will be~     participating in this study.~      A screening will be used to determine subject suitability for inclusion in the trial.~     Subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one~     day treatment period. During this period, 4 anal manometric studies will take place. Study~     medication (Coated Phenylephrine suppositories at various doses) will be administered at~     pre-determined intervals.~   "
197955|NCT00971945|"~     The purpose of this study is to evaluate the safety and efficacy of continued administration~     of paclitaxel given weekly in subjects considered to need to continue treatment after~     completion of the preceding Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with~     Advanced Breast Cancer (Protocol No. CA139-371)~   "
197861|NCT00973180|"~     The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx~     container label design to improve patients' understanding of instructions for use.~      The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy~     of the enhanced Rx container label to improve patients' understanding of actual prescribed~     medicines, compared to a standard label format. Patients with type II diabetes and/or~     hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts~     Central - NSC) receive their prescribed medicines from this location. Recruited subjects in~     this study will be randomly assigned to either intervention (enhanced Rx container label) or~     control (standard Rx label). All pill-form, regular dosing schedule medicines, including~     diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment~     will be labeled according to study arm by the central-fill pharmacy. Study subjects will be~     interviewed at the time of dispensing the prescribed medicines at the clinic, again three~     months later (dispensing of refill), and finally nine months after baseline (dispensing of~     refill). Pharmacy refill data and medical record information - linked at these clinics - will~     be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label~     instructions, including auxiliary warnings, will be the primary outcomes. Other exploratory~     outcome measures will also be measured, including 1) adverse effects associated with~     medication use defined by a) the rate of physician visits, b) the rate of emergency room~     visits, and c) the rate of hospitalizations and hospital admissions via emergency rooms for~     medication side effects (e.g. hyperglycemia or hypoglycemia); and 2) health outcome as~     measured by the change from baseline in hemoglobin A1c (HbA1c) and blood pressure~     measurements. Data from the actual use trial will be processed, reviewed, analyzed (in order~     of hypotheses), and reports prepared during the final months of this last phase of the study.~   "
197862|NCT00973167|"~     Fragility fracture is common due to global aging problem, incurring huge healthcare~     expenditure. The occurrence of fragility fracture is usually caused by a fall incidence of an~     elderly with low bone quality and poor balancing ability. Therefore, any approach to improve~     or retard both sarcopenia and osteoporosis will be helpful to prevent osteoporotic fracture~     incidence. With the intensive research on low magnitude high frequency vibration (LMHFV),~     many scientific evidences support the application of this biophysical modality on elderly to~     maintain or improve the musculoskeletal tissues in elderly.~      Many previous studies showed the osteogenic properties of vibration treatment and its~     positive effects on muscular performance and blood circulation. The investigators' previous~     reports also indicated that LMHFV could enhance the bone quality in spine and tibia in~     elderly after one-year intervention, as well as the balancing ability with high compliance.~     In animal studies, the application of LMHFV on fracture healing also demonstrated the~     significant acceleration of healing by inducing callus formation and maturation, from which~     upregulation of collagen I, II and BMP-2 gene expression was detected at molecular level. To~     date, the long-term efficacy of LMHFV on reducing fracture risks and fracture rate is,~     however, not available, which needs a systematic large-scale study to answer this important~     research question.~      Therefore, the hypothesis of this study is that LMHFV can maintain or enhance the performance~     of various tissues of the musculoskeletal system in community elderly, thus reducing the~     fracture risks and fracture rate. A large-scale prospective randomized clinical trial will be~     conducted in multiple communities to investigate the long-term effect of LMHFV on fracture~     rate and reduction of fracture risks in community elderly, in which multi-factorial effects,~     in terms of muscle and bone, on musculoskeletal system will also be evaluated. A total of 704~     elderly from 28 community centres will be recruited within 1.5-year time for a 18-month LMHFV~     treatment, who will be assessed on the fracture risks at fixed time points while their~     fracture rates on the third year of this study will be regarded as primary outcome for~     analysis. The findings of this study will provide very useful scientific data to support the~     application of LMHFV for elderly. The ultimate goal is to reduce the fracture rate and the~     quality of life of community-living elderly.~   "
197863|NCT00973154|"~     Background: An intact hypothalami-pituitary-adrenal (HPA) axis with an effective~     intracellular anti-inflammatory activity of glucocorticoids is indispensable for host~     survival during stress upon exposure to an infectious agent. Community-acquired pneumonia~     (CAP) is characterized by significant mortality and increased circulating inflammatory~     cytokines. Despite adequate antimicrobial therapy mortality rates for CAP have not changed~     over several decades. The use of corticosteroids in patients with CAP is inconclusive.~      Study aim: To compare a 7 days treatment with prednisone and placebo in patients with~     community-acquired pneumonia with respect to time to clinical stability.~      Study hypothesis: The investigators hypothesize that use of corticosteroids will lead to a~     25% relative risk reduction for death and clinical instability.~      Study type: randomized double blind intervention study~      Patients: 800 patients with community-acquired pneumonia~   "
197864|NCT00973141|"~     The purpose of this study is to compare the safety and effectiveness of different doses of~     JNJ-42160443 with placebo in the treatment of chronic, moderate to severe knee or hip pain in~     patients with a diagnosis of osteoarthritis.~   "
197865|NCT00973128|"~     The present study was designed as a randomized, single blind, placebo-controlled, study to~     evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and~     associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d~     for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat~     cutaneous leishmaniasis ulcers.~   "
197866|NCT00973115|"~     The purpose of this study is to evaluate the efficacy and safety of morning versus evening~     intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with~     hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL)~     cholesterol percent change.~   "
197867|NCT00973102|"~     Annually in the United States, approximately 30 million people require treatment for~     traumatic injuries in emergency departments. Two million of these patients require~     hospitalization, with several hundred thousand ultimately dying, often due to extreme blood~     loss. Importantly, these traumatic injuries are the leading cause of death and disability for~     children and young adults under the age of 44, with the total cost of trauma in the U.S.~     approaching $260 billion each year.~      Despite advances in pre-hospital care, early resuscitation, surgical interventions and~     intensive care monitoring aimed at the primary traumatic injury, many survivors never~     recover. A significant cause of this mortality and morbidity is thought due to potentially~     preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in~     the first few hours after the severe traumatic event.~      In spite of the current bleak outlook for many of these patients, a series of animal~     investigations have uncovered a promising solution to the problem of the secondary injury~     seen in hemorrhagic shock and other similar processes, namely the early administration of~     estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound. Based on~     these encouraging results from animal studies, the investigators hypothesize that early~     administration of IV Premarin® in patients with hemorrhagic shock will safely reduce~     secondary injury, and improve survival.~   "
197868|NCT00973089|"~     The purpose of this study is to evaluate the success rate of alternative treatment of deep~     carious lesions in asymptomatic primary teeth with no clinical nor radiographic signs of~     pulpal inflammation. The treatment includes leaving a thin layer of caries that is present~     near the pulp chamber and includes liner placement and tooth sealing. This alternative~     treatment is to be compared with the treatment provided today to these teeth, which includes~     complete removal of caries and probably includes pulpotomy and wide preparation of the tooth.~     The study also evaluates the cost-effectiveness of both methods of treatment of deep carious~     lesions.~   "
197869|NCT00973076|"~     The primary objective is to assess the safety and tolerability of AZD8055 in Japanese~     patients with advanced solid tumours.~   "
197870|NCT00973063|"~     The purpose of this study is to determine whether routine sterile gloving can lower~     contamination rates in blood culture.~   "
197876|NCT00972985|"~     This placebo-controlled crossover study is intended to measure the effect of three, common~     neuroactive medications on brain activity measured by magnetoencephalography (MEG) and~     electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple~     cognition testing on 15 healthy volunteers over 4 study days. Subjects will receive placebo~     on one of the study days, and either 100 mg modafinil p.o., 20 mg methylphenidate p.o., or 1~     mg lorazepam p.o. on remaining study days. Medication administration will be randomized~     according to study day so that each subject will receive the medications in random order.~     Brain activity will be measured by MEG and EEG in each subject a total of 4 times each study~     day: prior to medication administration and 2, 4, and 6 hours after medication~     administration. Cognition testing will be performed at pre-medication baseline and~     immediately after each post-medication scan time. This study will test the hypothesis that~     changes in brain functional activity can be accurately measured in healthy volunteer subjects~     after single, acute doses of modafinil, methylphenidate and lorazepam.~   "
197877|NCT00972972|"~     The purpose of this study is to determine whether dietary intervention with blueberry and~     grape juice extracts in elderly men with subjective memory problems would raise performance~     on neuropsychological memory tests and change biomarker of muscle damage and whole blood gene~     expression profiles.~   "
197878|NCT00972959|"~     The aim of this study is to evaluate the effect of bortezomib in combination with~     dexamethasone and zoledronic acid on bone mineral density (BMD) and skeletal related events~     (SREs) in Patients with Multiple Myeloma who Have Relapsed after 1-3 Prior Lines of Therapy~   "
197879|NCT00972946|"~     The ability to label specific cells and image their natural movements in vivo would allow~     researchers to investigate the mechanisms of disease progression. In addition, cell-based~     therapy, especially stem cell therapy, requires non-invasive monitoring of transplanted cells~     to follow their bio-distribution and biological function. Because of recent interest in stem~     cell treatment, several methods have been investigated for in vivo cell tracking. The~     investigators propose to assess whether the magnetic resonance imaging (MRI) contrast agent~     Endorem (superparamagnetic particles of iron oxide) can be used to label cells for in vivo~     tracking using MRI. The investigators will use 20 healthy human volunteers to:~        1. Assess the feasibility of imaging Endorem-labelled cells in vivo~        2. Compare the distribution of Endorem-labelled cells with that of intravenous injection of~          Endorem~   "
197880|NCT00972933|"~     Ipilimumab is a manufactured monoclonal antibody, much like the antibodies usually made by~     the human body to fight off infection; however it is not known why the human body does not~     fight off a cancerous tumor. The idea behind developing this experimental drug is to~     stimulate the immune system to make antibodies to kill cancer cells. This research study is~     considered experimental because it has not received approval from the Food and Drug~     Administration (FDA) for the treatment of this type of cancer.~      This monoclonal antibody has been specifically made to block Cytotoxic T Lymphocyte Antigen 4~     (CTLA4), which is a protein found on cells of the immune system. CTLA4 seems to slow down the~     immune response, so blocking it with an anti-CTLA4 antibody may make the immune response more~     active. The purpose of this study is to see if Ipilimumab affects the response of the~     patient's immune system toward their cancer.~   "
197881|NCT00972920|"~     Transversus abdominis plane (TAP) block is an application of local anaesthetic solution into~     the plane between internal oblique and transversus abdominis muscles at the triangle of Petit~     located superiorly to the iliac crests bilaterally. Anterior divisions of segmental spinal~     nerves, which provide innervation to the abdominal wall, run inside this compartment. TAP~     block been shown to provide good postoperative pain relief following surgical laparotomies,~     gynaecological laparotomies, appendicectomies, inguinal hernia repairs and open~     prostatectomies. The goal of this study is to compare the effect of blind and~     ultrasound-guided TAP block on postoperative pain relief and morphine consumption following~     to gynaecological laparotomies. Null research hypothesis for the study is that there is no~     difference between the performance (as defined by morphine consumption and patient~     satisfaction/ pain scores) of the TAP block procedure via 'blind' or ultrasound guided~     techniques for gynaecological laparotomies.~   "
197882|NCT00972907|"~     This is an open label study. The study will consist of 1 treatment group: coated Nifedipine~     suppository containing 12 mg of Nifedipine, administered BID to subjects with chronic anal~     fissure.~   "
197883|NCT00972894|"~     The investigators are comparing three different methods of testing for an infection which is~     commonly found in women. The infection is caused by a bacterium called Group B Streptococcus.~     About 10−30% of women carry GBS in the vagina or rectum.~      During labour this infection can be passed to the neonate. This can lead to the baby~     developing a serious infection.~      However, research has shown that if antibiotic treatment is given to GBS carrying women~     during labour most of these infections can be avoided.~      A new bedside test known as PCR has been shown to produce a GBS diagnostic result in less~     than an hour. In clinical trials conducted in the US and France this method has been shown to~     be more accurate than either prenatal vaginal swabs or risk factor assessment. For this~     reason, PCR may be helpful in screening and treating GBS positive women in the UK.~      In this study the investigators will compare each of the following three methods of diagnosis~     to a gold standard.~        -  Prenatal vaginal culture swab (at 35 to 37 weeks gestation)− The US approach.~        -  Risk factor assessment (at the time of admission for labour)− The UK approach~        -  The new PCR test (at the time of your labour admission)~      The investigators will compare the accuracy of each of these methods with the most accurate~     method for determining the GBS status during labour. This 'most accurate' method is a highly~     sensitive swab test which unfortunately takes several days to produce a result. For this~     reason this test will not tell the investigators whether prophylactic antibiotics may be~     useful during labour (Receiving them after birth is ineffective).~      If PCR is shown to be a more accurate method of identifying GBS positive women this may help~     to reduce the number of infections in new born infants and as a result may help to save~     lives.~   "
197901|NCT00972660|"~     Study Design: Treatment, Randomized, Open Label, Parallel Assignment,Safety/Efficacy Study.~      The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells~     (MSC) expanded ex-vivo infusion for the treatment of patients who have developed a newly~     diagnosed extensive or refractory chronic graft versus host disease (chronic GVHD) to the~     usual therapeutic measures.~   "
197884|NCT00972881|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy, cetuximab, and~     radiation therapy before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed.~      PURPOSE: This phase I/II trial is studying the side effects of giving capecitabine and~     irinotecan hydrochloride together with cetuximab and radiation therapy and to see how well it~     works in treating patients undergoing surgery for locally advanced rectal cancer.~   "
197885|NCT00972868|"~     The purpose of this study is to determine the feasibility, safety and efficacy of a~     unidirectional breathing mask (breathe in through the nose and out through the mouth or~     breathe in through the mouth and out through the nose) in COPD patients with breathing~     difficulties requiring noninvasive positive pressure ventilation (NPPV).~   "
197886|NCT00972855|"~     The objective of this study is to compare the rate and extent of absorption of bicalutamide~     50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under fed~     conditions.~   "
197887|NCT00972842|"~     A standard therapy is neither established in first-line patients nor in relapsed patients~     with PTCL, and there is still an unmet medical need to identify novel efficacious and safe~     therapy regimens.~      The aim of this study is to evaluate the potential of a Lenalidomide plus Vorinostat and~     Dexamethasone combination therapy as an effective and safe therapeutic regimen, in the~     treatment of relapsed PTCL following failure of prior regimens.~   "
197888|NCT00972829|"~     Recently, research studies have shown that patients who have had trouble taking statins every~     day, are able to take statins if they take them only once or twice a week. The investigators~     are doing a research study which involves switching people who are taking ezetimibe to the~     statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it~     is tolerated.~   "
197889|NCT00972816|"~     This study will evaluate the safety and immunogenicity of different combinations of A/H1N1~     S-OIV (swine flu) vaccine in healthy young children.~   "
197890|NCT00972803|"~     Dental plaque is a well known etiologic factor for gingivitis. Recently, herbal extracts are~     a matter of scientific interest to inhibit plaque accumulation on teeth. The purpose of this~     study was to evaluate the effects of pistacia Mutica (PM) mouth wash on de novo dental plaque~     plaque formation, gingival inflammation indices and oral microorganisms.~   "
197891|NCT00972790|"~     The objective of this study is to demonstrate that scalp nerve blocks (scalp freezing),~     performed at the end of supratentorial brain surgery, will reduce post-operative pain,~     opioids side effects, and the time required for post-anaesthesia care unit (PACU)/Intensive~     Care Unit (ICU) and hospital discharge.~   "
197892|NCT00972777|"~     This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin~     ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis.~     This study was conducted as a phase IIb study and continued with further enrollment as a~     phase III study.~   "
197893|NCT00972764|"~     The purpose of this study is to expose some of the factors that may be associated or~     predisposing to development of laryngomalacia.~   "
197894|NCT00972751|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at protein expression in tumor tissue samples from~     patients with stage II or stage III rectal cancer enrolled in clinical trial SWOG-9304.~   "
197895|NCT00972738|"~     This study will assess the treatment effect of montelukast versus placebo over a 2 week~     period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an~     active comparator.~   "
197896|NCT00972725|"~     The purpose of this study is to evaluate the safety and reactogenicity of one booster dose of~     a HIV candidate vaccine after administration of one oral dose of chloroquine.~   "
197897|NCT00972712|"~     The purpose of this study is to test the effect of the combination of bortezomib and~     tipifarnib. Bortezomib (VELCADE) is approved by the Food and Drug Administration (FDA) for~     the treatment of multiple myeloma patients who have received at least one prior therapy.~     Tipifarnib is not yet approved by the FDA and is an investigational drug. Investigational~     means that the drug is still being studied and that research doctors are trying to find out~     more about it. Because these drugs have not been used together before, it is not clear which~     dose of each agent is optimal when used in combination.~      This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drugs to use for further studies. The investigators will test the safety of~     BORTEZOMIB and TIPIFARNIB together and see what effects (good and bad) it has on you and your~     MULTIPLE MYELOMA, and to find the highest dose of both agents that can be given without~     causing severe side effects.~   "
197898|NCT00972699|"~     The purpose of this study is to test a mother-to-mother intervention during pregnancy and~     after delivery with Mothers Living with HIV (MLH)in South Africa. We hypothesize that the~     intervention will enhance the adjustment of the children of MLH by improving the health and~     mental health of MLH which benefits their children, as well as the MLH.~   "
197899|NCT00972686|"~     P3K112826 is a Phase I, first-time-in-human dose escalation study in subjects with refractory~     malignancy. The primary objective of this study is to determine the recommended Phase II dose~     of GSK2126458 based on safety and tolerability, pharmacokinetics, pharmacodynamics and~     preliminary evidence of clinical activity. Secondary objectives are to characterize the~     pharmacokinetics of GSK2126458; and to explore relationships between GSK2126458~     pharmacokinetics, pharmacodynamics, response prediction biomarkers and clinical endpoints.~   "
197900|NCT00972673|"~     This is a randomized, double blind, placebo controlled, parallel-group, repeat dose study to~     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose~     from a novel dry powder device in healthy Japanese male subjects.~   "
197902|NCT00972647|"~     Introduction: The orthopaedic surgeon is frequently exposed to ionizing radiation, especially~     during intraoperative fluoroscopy. It is expected that using a laser guided fluoroscopy~     technique, which should improve accuracy of radiography, should also reduce the amount of~     time of exposure to radiation. Finally, the literature appears controversial in this matter~     with no clear conclusions that could be drawn from such.~      Hypothesis: The test hypothesis is that the use of the laser-aiming device for fluoroscopy in~     several orthopaedic procedures will reduce the exposure of the patient and the surgeon to the~     damaging effects of radiation. The null hypothesis then states that there will be no~     difference in exposure to radiation between the group using the laser device and the group~     not using the apparatus.~      Methods: A prospective randomized controlled trial will be performed in which patients~     undergoing fluoroscopy will be randomly allocated to two groups. One group will undergo~     imaging with use of the device throughout the procedure and the other group will undergo~     radiation without the laser guided device. Number and time of exposure will be recorded for~     each procedure. It is of the utmost importance that the complexity of the procedures remains~     relatively similar. It is believed that a good measure of complexity is the surgical time.~     Therefore, any procedures that are statistically similar from a set mean (p > 0.05) would be~     included into the study. It is also important that one or two surgeons with similar expertise~     and years of experience perform the surgeries to avoid confounding factors. It is expected~     that throughout the duration of the study (8 weeks) 50-100 cases would be reported which~     would produce statistically significant results. The results will be analyzed by calculating~     confidence intervals and differences between means of continuous data and significance levels~     by the Student's t test. Statistical significance will be set to P < 0.05.~      Risks and Benefits: This study involves minimal risk. The use of the laser guide will not~     increase or introduce any risks other than the associated inherent surgical risks. The risks~     usually associated with this type of studies concern breach of confidentiality. To reduce~     this risk, research numbers will be assigned to subjects' data collected during the~     procedure, whose personal information will be found in another password-protected database.~      This study will help the investigators to investigate a technique that may help reduce the~     amount of time that a patient is exposed to radiation.~   "
197903|NCT00972634|"~     RATIONALE: A computer-based system for assessing symptoms may be effective for patients with~     metastatic or advanced cancer.~      PURPOSE: This clinical trial is studying how well computerized questionnaires work in~     assessing symptoms, pain, depression, and physical function in patients with metastatic~     and/or advanced local/regional cancer.~   "
197904|NCT00972621|"~     The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic~     viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared~     to a currently marketed viscoelastic material.~   "
197905|NCT00972608|"~     The purpose of this study is to utilize cardiac imaging data acquired as part of the standard~     of care for these patients, such as MRI, 3D echo, and CT, and existing 3D reconstruction~     protocols to assess the feasibility of using surgical planning in the treatment of patients~     with complex cardiac defects. The specific aims of the project are as follows:~        1. Develop a protocol to reconstruct heart models from patient imaging data and perform~          virtual surgery on reconstructed 3D anatomy using appropriate, pre-existing patient~          datasets.~        2. Use the developed protocol to prospectively plan and evaluate the possible surgical~          options for new patients.~        3. Validate that the optimal virtual anatomy agrees with what was surgically implemented~          using post-operative patient scans, when available.~   "
197906|NCT00972595|"~     This study will assess the bioequivalence of a Merck clinical trial formulation of~     ondansetron compared to a non-U.S. marketed formulation of ondansetron.~   "
197907|NCT00972582|"~     When dietary amino acid supplements are consumed by humans they are normally in addition to~     their normal daily requirements. The investigators' laboratory played a leading role in~     defining the estimated average requirement (EAR) and the recommended dietary intake for the~     essential amino acids (Dietary Reference Intakes 2005). The other important but less well~     studied component of Dietary Reference Intakes (DRI) is - What is a safe upper limit of~     intake? The investigators now propose to determine the safe upper limits of the dietary~     essential amino acids. The recently published DRI (2005) defines the Tolerable Upper Intake~     Level (UL) as 'the highest average daily nutrient intake level that is likely to pose no risk~     of adverse health effects to almost all individuals in the general population.' As intake~     increases above the UL, the potential risk of adverse effects may increase'. In this~     proposal, the investigators define a novel method to define the safe upper limit where the~     'maximum oxidative potential' of an amino acid identifies the 'metabolic limit' to dispose~     the amino acid. Intakes of amino acid above this level will increase the potential for~     adverse effects to appear.~   "
197908|NCT00972569|"~     The purpose of the study is to determine if low doses of BNP can improve renal function in~     people with chronic heart failure with renal dysfunction, also to determine whether~     Sildenafil assists with improvement. This study will enroll only hospitalized patients with~     heart failure.~   "
197909|NCT00972556|"~     This prospective clinical randomized controlled trial is established to compare the clinical,~     radiographic, and histological treatment outcomes between MTA and FC in pulpotomized human~     primary molars at 6, 12, 18, 24 month post-treatment and to test the hypothesis that Gray~     Mineral Trioxide Aggregate (GMTA) is a viable alternative to Diluted (20%) Formocresol (DFC)~     in pulpotomies treatment of human primary molars.~   "
197910|NCT00972543|"~     The primary purpose of the study is to evaluate the safety and efficacy of Raptiva® compared~     to placebo in controlling moderate to severe chronic plaque psoriasis involving palms and/or~     soles scoring Palmo-plantar Pustular Psoriasis Area and Severity Index (PPPASI) ≥5 in~     subjects that are candidates for phototherapy or systemic therapies.~      The rational of the trial is that psoriasis involving palms and/or soles is a painful~     condition associated with fissuring, scaling and in some instances with pustulation. Because~     of its localization, it is a disabling condition that limits dexterity and affects social~     interaction, leading to compromised quality of life; and this confers additional severity to~     that of plaque psoriasis on the body. The therapeutic approach for palm and sole plaque-type~     psoriasis usually begins with topical corticosteroid treatment. If the disease reaches a~     certain extent, the next step involves the addition of systemic treatments. Substances like~     methotrexate, retinoids and cyclosporine have shown to be efficacious, but their long-term~     usage is often limited by toxicity. Biologic treatments for psoriasis avoid this toxicity and~     offer a new therapeutic approach.~      The therapeutic potential of Raptiva® to treat palm and sole psoriasis refractory to systemic~     treatments has been described in numerous case reports and in one placebo-controlled phase IV~     study. However, in all cases, the number of subjects included was low, and in most cases the~     trials were not prospectively designed.~      Since the efficacy of Raptiva® on psoriasis of palms and soles must be determined using the~     validated PPPASI measure, it is necessary for scientific and ethical reasons to include a~     placebo arm during the first 12 weeks. Finally, as the clinical response may sometimes take~     longer than 12 weeks, subjects must be treated and evaluated during an additional 12-week~     open-label extended treatment period.~   "
197925|NCT00972348|"~     This is a research study to determine if a personal health record, called myHERO, will help~     improve health. A personal health record is a secure internet (also called online) tool that~     contains personal health information like medications, diagnosed conditions, allergies and~     laboratory values (like CD4 cells and viral load). This study will also help explain if a~     personal health record influences the relationship with a doctor or nurse practitioner and~     their patients. The purpose of this study is to determine if a personal health record will~     influence health. The content of your personal health record is as secure as possible for any~     online health information.~   "
197911|NCT00972530|"~     BACKGROUND: Intra-articular glucocorticoid injections are frequently used to relieve symptoms~     of arthritis. Postinjection rest has been shown to improve the outcome of knee joint~     injections, but not for wrist injections. Consequently, different joints respond differently~     on postinjection regimens.~      OBJECTIVES: To investigate whether better treatment results might be achieved of~     post-injection rest following intra-articular glucocorticoid treatment for elbow synovitis.~      METHODS: 90 patients with rheumatoid arthritis (RA) and elbow synovitis were treated with 20~     mg intra-articular triamcinolone hexacetonide and randomised to either a 48 hour~     immobilisation in a triangular sling (n=46) or normal activity without restrictions (n=44).~     Primary endpoint was relapse of synovitis. In addition, pain, function according to a self~     assessment questionnaire (PREE) and range of movement were followed for six months.~   "
197912|NCT00972517|"~     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     investigational vaccine GSK2340272A in children aged between 3 and 17 years.~   "
197913|NCT00972504|"~     This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess~     the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg)~     and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal~     allergic rhinitis.~   "
197914|NCT00972491|"~     Laryngeal mask airway (LMA) is routinely used for some patients who have surgery under~     general anesthesia. LMA is placed in the mouth and allow the anesthesia to be given without~     having to put a breathing tube in the throat. Previous studies have focused on the effect of~     different anesthesia medicines on optimal condition for LMA use. The objective of the present~     study is to find the optimal time for LMA insertion.~   "
197915|NCT00972478|"~     This phase I/II trial is studying the side effects and best dose of vorinostat when given~     together with rituximab and combination chemotherapy and to see how well it works in treating~     patients with newly diagnosed stage II, stage III, or stage IV diffuse large B-cell lymphoma.~     Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as~     rituximab, can block cancer cell growth in different ways. Some block the ability of cancer~     cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing~     substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin~     hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     vorinostat together with rituximab and combination chemotherapy may kill more cancer cells.~   "
197916|NCT00972465|"~     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical~     efficacy has been shown in adult with head and neck cancer. The study assessed the safety,~     and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy~     in patients with advanced colorectal cancer.~   "
197917|NCT00972452|"~     The investigators wish to determine whether a short period of exercise training (5-10 days)~     improves the metabolic and cardiovascular response of people with or at risk of developing~     type 2 diabetes to eating a meal. In healthy people, blood flow to skeletal muscles increases~     after eating a meal, and this helps to regulate blood sugar levels by delivering blood sugar~     to muscles where it can be stored or metabolized. In people with or at risk of type 2~     diabetes, blood flow does not increase as much after eating a meal, and this may contribute~     to elevated blood sugar concentrations observed in these individuals. The investigators wish~     to determine whether exercise can improve this response.~   "
197918|NCT00972439|"~     The purpose of this research study is to gain a better understanding of the changes that may~     occur in the breast when a woman uses an oral contraceptive (birth control pill). Some~     research indicates that women who use birth control pills with lower amounts of progestin (a~     hormone in the birth control pill) may have lower breast cell growth than women who use birth~     control pills with a higher amount of progestin; this research will examine that in detail.~   "
197919|NCT00972426|"~     The primary objective of the clinical study is to evaluate the efficacy and safety for~     Mikelan LA eye drops 2% (once per day) of intra-ocular pressure decreased.~   "
197920|NCT00972413|"~     The primary aim of this study is to investigate the use of cone beam computed tomography~     (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of~     evidence incorporating both non-contrast and contrast enhanced CBCT in the study protocol.~     The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the~     diagnostic work-up of breast lesions.~   "
197921|NCT00972400|"~     RATIONALE: Gathering information over time from blood samples and measurements of activity,~     sleep, mood, and cognition may help doctors learn more about fatigue in breast cancer~     survivors and plan the best treatment.~      PURPOSE: This clinical trial is studying fatigue in breast cancer survivors.~   "
197922|NCT00972387|"~     The purpose of this study is to assess whether the greater performance benefits from~     ingesting carbohydrate-protein supplements during endurance running, in comparison to the~     traditionally used carbohydrate supplement, is attributed to the extra calories contained in~     the carbohydrate-protein supplement or the presence of protein.~   "
197923|NCT00972374|"~     This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200~     μg and 400 μg brimonidine tartrate) on visual function in patients with previous~     rhegmatogenous macula-off retinal detachment.~   "
197924|NCT00972361|"~     Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or~     ventilation tubes insertion in children.~      A proportion of those children reveal borderline abnormal values of Partial Prothrombin Time~     (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for~     further evaluation and recommendations before surgery.~      The purpose of this study is to summarize the causes of referrals in a cohort of 200 children~     and to assess the further laboratory analysis preformed and the results obtained.~   "
197926|NCT00972335|"~     In this multicenter, Phase II trial, the investigators plan to evaluate the activity of the~     combination of bevacizumab and everolimus in patients with recurrent, progressive meningioma~     following maximal treatment with surgical resection and local radiation therapy. Although~     these patients are relatively rare, there is currently no established standard of treatment~     for a disease that causes a great deal of morbidity, and that is eventually fatal.~   "
197928|NCT00972309|"~     Background:~        -  PSA (prostate specific antigen) is a protein found on normal and cancerous prostate~          cells. Levels of this protein are used to identify men who are at risk for prostate~          cancer and to monitor responses to treatment in men who have been diagnosed with~          prostate cancer.~        -  Research has shown that men who continue to have an elevated PSA level following primary~          treatment for prostate cancer are at increased risk for cancer progression. Studies have~          shown that the change in PSA levels over time, or PSA doubling time (PSADT), can be~          accurate in predicting how quickly the cancer is likely to progress. Individuals with a~          PSADT of less than 3 months are at extremely high risk for disease progression and death~          from prostate cancer. Individuals with a PSADT of greater than 15 months have a very low~          risk of death from prostate cancer.~        -  TARP is a protein that is found in about 95% of prostate cancers and is known to~          stimulate the immune system. The TARP prostate cancer vaccine is made from pieces of the~          TARP protein called peptides and includes peptides that have been modified to make them~          more effective at stimulating immunity. Although these TARP peptides have been shown to~          stimulate the immune systems of mice, information is needed to determine if they also~          stimulate the immune system in humans. Since it is unclear what is the best way to give~          peptide vaccines, the TARP peptides will be given with substances known to stimulate the~          immune system or in a vaccine made with the patient s own cells.~      Objectives:~        -  To determine the immune system s response to vaccination with TARP peptides.~        -  To determine the safety and toxicity of TARP peptide vaccination.~        -  To determine if vaccination with the TARP prostate cancer vaccine can slow down PSADT in~          men with an intermediate PSADT of 3 to 15 months.~      Eligibility:~        -  Males 18 years of age and older who have completed their primary treatment for prostate~          cancer, have stage D0 disease, are HLA A*0201 positive and who have a PSADT greater than~          3 and less than 15 months.~      Design:~        -  Patients will be randomized to one of two treatment arms:~        -  Arm A will receive the TARP vaccine with other substances that stimulate the immune~          system.~        -  Arm B will receive the TARP vaccine that includes a patient s own white blood cells.~        -  First week of study, after screening for eligibility has been completed:~        -  Day 1: Apheresis procedure to extract white blood cells to test the immune response to~          the vaccine.~        -  Day 3: Flu vaccine to allow researchers to determine how well a patient s immune system~          is working.~        -  Clinic visits in Weeks 3, 6, 9, 12, and 15 for physical examination, blood samples, and~          administration of the TARP peptide vaccine.~        -  Physical examination and blood samples only in Weeks 18 and 36.~        -  Additional blood samples and apheresis procedures in Weeks 24 and 48.~        -  A 6th dose of TARP peptide vaccine will be administer to those patients who have a~          response to vaccination at week 24.~        -  No follow-up or long-term study is associated with this study.~   "
197929|NCT00972296|"~     This project proposes to examine the difference in effectiveness of fracture boots and carbon~     fiber braces in the management of gait abnormalities and pain relief due to ankle pain from~     arthritis due to ankle bleeds. Fracture boots are walking casts that you can put on and~     take off. They prevent the ankle from moving and have a curved sole to mimic normal walking.~     They can help relieve pain of ankle arthritis from ankle bleeds by stopping ankle motion and~     absorbing some of the body's own weight while walking. Carbon fiber braces use newer~     technology resulting in lighter and smaller braces. They are designed to assist with helping~     clear the toe and straighten the knee while walking.~      Gait analysis wearing both the fracture boot and carbon fiber brace will be performed by~     walking on a mat equipped with pressure sensors and will examine the effect of the fracture~     boot and the carbon fiber brace on how you walk. These tests will be compared to walking on~     the mat without either brace. The sensors on the mat will measure different aspects of gait~     such as step length and foot position. You will be asked questions about how much ankle pain~     you have using no brace compared to each brace.~      People with hemophilia A or B and ankle pain from bleeds will be asked to participate. They~     will be approached during routine clinic visits and will also be contacted by telephone.~      Levels of pain will be measured before, during and after each trial using standardized visual~     analog and ordinal pain scales. Measurements from the gait mat and levels of pain relief will~     be used to determine effectiveness of each type of support.~      Statisticians will be used to analyze results of the gait mat and pain scale measurements.~   "
197930|NCT00972283|"~     This trial is conducted in Africa, Asia, Europe, and the United States of America (USA).~      The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin~     glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without~     pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the~     long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with~     or without metformin and with or without pioglitazone in subjects with type 2 diabetes.~      All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial~     participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.~      Subjects who consent to participate in the extension trial (NN1250-3667) will continue to~     receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.~      The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension~     period is registered as NN1250-3667.~   "
197931|NCT00972270|"~     This is a randomized trial investigating the use of the IMPELLA RECOVER LP 2.5 compared to~     Intra-aortic balloon pump (IABP) in patients with Acute Myocardial Infarction.~   "
197932|NCT00972257|"~     The proposed study will compare for the first time the quality of 24-hour IOP control with~     Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination~     (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may~     determine the real efficacy of the two fixed combinations and the design of the proposed~     study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less~     than might be anticipated.~   "
197933|NCT00972244|"~     The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in~     Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of~     dapagliflozin to placebo when given in oral doses.~   "
197934|NCT00972231|"~     Iron overload impaired growth in Thalassemia patients due to iron deposition in the endocrine~     glands, including the hypophysis and gonads. The issue of iron overload in Sickle Cell Anemia~     is recently studied more extensively and preliminary studies shows that endocrine damage is~     rarer in those patients.~      Growth velocity was not systematically studied in patients with Iron Overload, even in~     thalassemia patients in spite several studies that assess the endocrine function in those~     patients. In Sickle Cell Patients this issue was not studied.~      The purpose of this study is to assess the growth velocity in a cohort of Thalassemia Major~     and Intermedia patients and compare the results to another group of Sickle Cell patients,~     including Sickle cell thalassemia.~   "
197935|NCT00972218|"~     Adalimumab is an antibody treatment that targets and neutralizes a molecule produced in the~     body that is associated with inflammation, tumor necrosis factor (TNF). This molecule is an~     important factor in causing the inflammation seen in people with a form of inflammatory~     spinal arthritis called spondylitis as well as inflammation in the bowel called Crohn's~     disease. Spondylitis and Crohn's disease tend to go together and this study will assess to~     what degree this treatment is effective for those patients that have both disorders at the~     same time.~   "
197956|NCT00971932|"~     The primary objective of this trial is to assess the antitumor activity of cetuximab when~     given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of~     recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese~     subjects.~   "
197936|NCT00972205|"~     Background:~        -  Some cancer cells have a large amount of a protein called P-glycoprotein, which can pump~          certain chemotherapy drugs out of their cells. This pump may be part of the reason why~          it is difficult to shrink some cancers with chemotherapy.~        -  In laboratory experiments, the drug CBT-1(Registered Trademark) blocked the~          P-glycoprotein pump, resulting in accumulation of higher amounts of chemotherapy inside~          the cancer cells, making the chemotherapy more effective.~        -  Paclitaxel is a cancer drug that has caused tumors to shrink in many types of cancers,~          including lung, ovarian, breast, renal, cervical and others.~      Objectives:~        -  To determine whether CBT-1(Registered Trademark) can block the P-glycoprotein pump on~          cancer cells and whether it inhibits the action of the pump found in normal blood cells~          and liver tissue.~        -  To evaluate the effectiveness of combination therapy using CBT-1(Registered Trademark)~          and paclitaxel in treating solid tumors and to determine whether the two drugs together~          are more effective than paclitaxel alone.~      Eligibility:~      -Patients over 18 years of age who have a solid tumor that cannot be treated successfully~     with standard treatments.~      Design:~      -Patients receive CBT-1(Registered Trademark) and paclitaxel in 21-day cycles. Treatment~     continues for two cycles after all the cancer is gone, or until it is decided to surgically~     remove some or all of the remaining cancer, or until the cancer has grown to the point where~     it defined as progressive disease.~      For each cycle, patients take CBT-1(Registered Trademark) by mouth in three divided doses~     daily for 7 days. On day 6, paclitaxel is given through a vein over 3 hours.~      Blood tests are done before starting CBT-1(Registered Trademark) and repeated periodically~     throughout treatment.~      Imaging studies computed tomography or magnetic resonance imaging (CT or MRI) are done every~     two cycles. In addition, for the first cycle only, patients undergo imaging of tumors and~     normal tissue with a 99mTc-sestamibi radionuclide scan before and after administration of~     CBT-1(Registered Trademark). This scan helps show how well the P-glycoprotein pump is being~     blocked by the treatment.~   "
197937|NCT00972192|"~     This study compared the effectiveness of inpatient routine VCT to referral for post-discharge~     VCT in terms of the number of new HIV infections identified, linkage to care for HIV infected~     individuals and reduction in HIV risk behavior.~   "
197938|NCT00972179|"~     This study will follow a randomized, multiple-dose, double-blind, placebo-controlled,~     sequential dose-escalation study design. This healthy volunteer study will consist of five~     subcutaneous (SC) cohorts and one intravenous (IV) cohort. Each dose cohort will enroll 8~     subjects, randomized such that 6 subjects will receive AMG 157 and 2 will receive placebo~     (3:1 ratio). The doses of AMG 157 planned to be evaluated include 35 mg (SC every 28 days,~     Cohort 1), 105 mg (SC every 28 days, Cohort 2), 210 mg (SC every 28 days, Cohort 3), 210 mg~     (SC every 14 days, Cohort 4), 210 mg (SC every 7 days, Cohort 5) and 700 mg (IV every 28~     days, Cohort 6).~   "
197939|NCT00972153|"~     The objective of this study is to determine whether the Air Barrier System device reduces~     airborne particulate and airborne colony forming units present at a surgery site.~   "
197940|NCT00972140|"~     The purpose of this study is to demonstrate the clinical equivalence of formoterol-HFA pMDI~     12µg/actuation administered twice daily to formoterol DPI 12µg/capsule delivered by the~     Aerolizer inhaler and administered twice daily in patients with COPD.~   "
197941|NCT00972127|"~     Primary:~        -  To assess the influence of acidified urinary pH on the renal excretion of Neramexane~      Secondary:~        -  To assess the influence of acidified urinary pH on the renal excretion of N-OH~          Neramexane~        -  To assess the steady state plasma pharmacokinetics (PK) of Neramexane and N-OH~          Neramexane under physiological conditions and under the conditions of urine~          acidification~        -  To assess safety and tolerability of a repeated dose treatment of Neramexane under~          physiological conditions and under the conditions of urine acidification~   "
197942|NCT00972114|"~     The purpose of this study is in a phase I/II safety and efficacy study to evaluate the~     clinical effect of coronary artery bypass graft (CABG) combined pedicled omentum wrapped~     autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy.~   "
197943|NCT00972101|"~     The goal of this clinical research study is to learn if treating umbilical cord blood with~     growth factors before a transplant can help to improve the body's ability to accept the cord~     blood transplants.~   "
197944|NCT00972088|"~     To show that prevalence of inflammation of the small bowel in patients with anorectal disease~     is under-diagnosed based on colonoscopy ileoscopy alone.~   "
197945|NCT00972075|"~     The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™~     2 mg in improving total night sleep duration and stabilizing the circadian clock phase in~     totally blind subjects with non-24 hour sleep-wake disorder.~   "
197946|NCT00972062|"~     The purpose of this study is to determine if an herbal over-the-counter cream can decrease~     skin site reactions in multiple sclerosis patients who currently take either Betaseron,~     Copaxone or Rebif as their subcutaneous medication for managing their multiple sclerosis.~     Injection site reactions have been indicated as one of the major reasons for discontinuing~     treatment with the subcutaneous medications (Betaseron, Copaxone, and Rebif) for multiple~     sclerosis.~   "
197947|NCT00972049|"~     The primary purpose of this study is to assess the safety and tolerability of AZD2516~     following administration of a single dose to Japanese healthy subjects.~   "
197948|NCT00972036|"~     This study is being done with a new therapy called Selective Internal Radiation Therapy~     (known as SIRT). Radiation is an effective treatment for destroying tumors. It is widely used~     in cancer treatment. However, radiation can harm normal tissue. SIR-Spheres are tiny plastic~     beads. They contain a radioactive agent called Yttrium-90. These beads can be delivered~     through a small tube inserted into the blood vessel that goes directly to the tumor. The~     radiation goes directly to the tumor. This spares healthy parts of your liver.~   "
197949|NCT00972023|"~     RATIONALE: Dehydroepiandrosterone (DHEA) may slow the growth of tumor cells and be an~     effective treatment for women with breast cancer.~      PURPOSE: This phase I trial is studying how well DHEA works in treating women undergoing~     surgery for stage I, stage II, or stage III breast cancer.~   "
197950|NCT00972010|"~     The purpose of this research study is to find out more about distinguishing between cancerous~     and non-cancerous breast cancer cells at the edges of tumors. Using an FDA approved device to~     remove tumors, this device will be tested to see if it causes less tissue damage and~     therefore makes it easier to examine the tumor and make sure it is all excised. The tumors~     will be excised by standard surgical technique, and then the effects of the device on the~     removed tissues will be studied.~   "
197951|NCT00971997|"~     The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c)~     level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day~     (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic~     control on oral antidiabetic drugs (OADs).~   "
197952|NCT00971984|"~     The study intends to summarize the clinical and laboratory characteristics of children with~     hemolytic anemia diagnosed as having alpha thalassemia mutations.~   "
197957|NCT00971919|"~     RATIONALE: Learning about chronic pain in women who have undergone surgery for breast cancer~     may help improve the quality of life for these patients and may help doctors plan the best~     treatment.~      PURPOSE: This clinical trial is studying chronic pain in women who have undergone surgery for~     stage I, stage II, or stage III breast cancer.~   "
197958|NCT00971906|"~     This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate~     immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new~     swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly~     subjects. A booster dose will be administered 12 months after the first vaccination.~   "
197959|NCT00971893|"~     The present study is designed to collect data on real world experience on use of Medrol in~     acute asthma in Indian patients.~   "
197960|NCT00971880|"~     Patients suffering from Thalassemia or another hemoglobinopathies required regular blood~     transfusions. The complications and adverse effects of blood transfusions can be classified~     as immediate and late. Among the immediate effects the most common are allergic reactions and~     fever, besides congestive heart failure in patients with cardiomyopathy. The late effects are~     mostly related to blood transmitted infections like HIV or Hepatitis C infections.~      The purpose of this study is to summarize the data of those complications in a cohort of 100~     patients receiving regular blood transfusion.~   "
197961|NCT00971867|"~     The purpose of this study is to provide access to paclitaxel therapy to subjects with~     advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388)~     and should have continued therapy with paclitaxel as the discretion of the investigator, and~     to evaluate the frequency and the severity of observed adverse reactions in treated subjects~   "
197962|NCT00971854|"~     Deep brain stimulation (DBS) involves placing electrodes into the brain. Through these~     electrodes, artificial electrical signals are chronically delivered into deep brain regions~     in order to alter abnormal brain activity. The artificial electrical signals are generated by~     a battery that is inserted under the skin of the chest. DBS is used to treat several~     disorders of movement, including dystonia. In dystonia, the electrodes are inserted into a~     brain region called the globus pallidus.~      Globus pallidus stimulation can be very effective therapy for dystonia. However not all~     patients are equally responsive and therapeutic outcomes can be frustratingly variable. The~     reason for this variability is unclear. Such variability in response may need to be met by~     tailoring stimulation to individual patients.~      Another issue with deep brain stimulation is battery life. Eventually, batteries become~     depleted and need to be replaced. Such battery replacements require an operation, hospital~     stay and the risk of introducing infection. The high electrical energy that has been used to~     treat dystonia means that batteries are typically replaced every year or two.~      The artificial electrical signals of deep brain stimulation are delivered with three~     parameters; frequency (Hertz - Hz), voltage (volts) and pulse width (microseconds). It has~     recently been reported that lower frequency stimulation, at 60Hz rather than 130Hz, can be~     used effectively to treat dystonia. Such 60Hz stimulation may be more effective for some~     patients than others. The lower energy demands of 60Hz stimulation would also greatly improve~     battery life (potentially doubling battery life).~      The aim of this study is to assess if 60Hz stimulation is more effective in ameliorating the~     dystonia of patients who have responded poorly to 130Hz pallidal stimulation. The current~     status of the evidence is one of clinical equipoise (uncertainty) and therefore suits a~     double blinded randomised trial.~   "
197963|NCT00971841|"~     The purpose of this study is to provide access to paclitaxel therapy to subjects with~     advanced or recurrent esophageal cancer who have completed the previous Phase 2 study~     (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating~     investigator(s). To evaluate the severity of observed adverse reactions in treated subjects~     for assessment of long-term safety.~   "
197964|NCT00971828|"~     This study will be co-ordinated by Dr Hector Chinoy, Dr Robert G Cooper (Salford Royal NHS~     Foundation Trust / The University of Manchester) and Dr Ian N Bruce (Central Manchester~     University Hospitals NHS Foundation Trust/ The University of Manchester). An initial pilot~     study will be completed, to establish proof of concept of the study and to examine whether~     trends may observed of differences between cases and controls.~      Twenty five prevalent UK Caucasian adult IIM cases, confirmed by internationally accepted~     criteria, will be recruited via the Adult Onset Myositis clinic, Salford Royal NHS Foundation~     Trust. Age, gender and race-matched controls will be recruited on a 'best friend' system. At~     the Wellcome Trust Clinical Research Facility (WTCRF), The University of Manchester,~     facilities are already available for B-mode ultrasound CIMT measurement, Endo-PAT, lean body~     mass measurement and contrast echocardiography. Cases and controls will have their~     cardiovascular risk factors assessed using a standardised questionnaire and blood tests.~     Further tests performed will include blood pressure, electrocardiogram, lean body mass,~     B-mode ultrasound CIMT measurement and Endo-PAT. IIM cases will have additional blood tests~     and a clinical assessment to assess their disease status, and contrast echocardiography. As~     part of a linked study, subjects (but not controls) will also have Gd-DTPA-MRI of the heart~     performed.~   "
197965|NCT00971815|"~     Chronic stress has been proposed to be involved the development of western life-style~     diseases such as cardiovascular disease and type 2 diabetes (T2DM). At the same time chronic~     stress is also believed to cause psychiatric disease such as melancholic depression (MD)and~     anxiety disorders.~      Accordingly, humans born with low birth weight (LBW) (ei. less than 5,0 LB) display an~     increased risk for T2DM and MD. Studies suggest stress and adrenal stress hormones~     (glucocorticoids) (GCC) might be involved in the development of both of these conditions.~      Recent studies of animals born LBW suggest, that SSRI-compounds, usually employed in the~     treatment of MD-related diseases, reduces stress-responses and levels of stress hormones such~     adrenal steroids and at the same time has a positive influence on glucose metabolism.~      In present study, the investigators aim to measure levels of GCC and stress and assess~     glucose metabolism in healthy young men (20-35 years) born LBW (40 subjects). The volume and~     structure of a certain brain area (ie. hippocampus) involved in regulation of adrenal GCC and~     known to be malfunctioning in chronically stressed individuals will be assessed by magnetic~     resonance imaging (MRI). Further metabolic examination will be accompanied by MRI~     spectroscopy of liver and muscle fat content as well as total fat content (Dexa-scanning) and~     contents of fat in the abdomen (by MRI) . Psychiatric well-ness and symptoms will be~     characterized by well-established questionnaires such as MDI and SCL-92 and responses as~     regards blood pressure, heart rate and changes in basal plasma concentrations of GCC and~     Epinephrine will be assessed while performing a Stroop Stress Test. Finally, a 24 hour blood~     pressure profile test will be included.~      After this extensive examination program, subjects will be randomized to 3-4 months of~     treatment with either Escitalopram (an SSRI-compound) or Placebo. Subsequently, at the end of~     the treatment, the whole examination program will be repeated to detect potential beneficial~     changes.~      A group of young normal birth weight men (20 subjects) will serve as a healthy baseline group~     for comparison and will not be exposed to any medical treatment.~      This trial will add understanding to the mechanism underlying the development of type 2~     diabetes and depression in LBW. Additionally, present trial might be capable of proposing a~     novel treatment strategy to prevent the development of these diseases in LBW man.~   "
197966|NCT00971802|"~     To evaluate the safety and tolerability of PF-03882845 in Healthy Volunteers. To evaluate the~     pharmacokinetics of PF-03882845 in Healthy Volunteers. To evaluate the pharmacodynamics of~     PF-03882845 in Healthy Volunteers.~   "
197999|NCT00971360|"~     The aim of this study is whether the proinflammatory cytokine levels in patients with~     conversion disorder is increased or not changed in the acute phase and subacute - chronic~     periode, compared with controls.~   "
197967|NCT00971789|"~     Background:~      People with phosphatase and tensin homolog deleted on chromosome 10 (PTEN) hamartomatous~     tumor syndromes (PHTS) have a mutation in one of their genes called PTEN that can lead to~     benign tumors called hamartomas throughout the body. This puts them at increased risk for~     breast, thyroid and endometrial cancer.~      People with a PTEN mutation have increased activity of proteins such as protein kinase B~     (AKT) and mammalian target of rapamycin (mTOR), which may be responsible for tumor growth and~     their increased risk of these cancers.~      Experiments show that a drug called sirolimus, which is used to prevent the immune system~     from rejecting transplanted organs, can inhibit cancer cell growth by blocking the mTOR~     protein.~      Objectives:~      To test the ability of sirolimus to decrease the activity of proteins that are regulated by~     mTOR in both benign and cancerous tumor tissue.~      Eligibility:~      People 18 years of age and older with Cowden syndrome or other PHTS.~      Design:~      Sirolimus treatment. Patients take sirolimus once a day in 28-day treatment cycles. Patients~     who do not have cancer take the drug for a total of two cycles (56 days) unless they develop~     unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until~     their disease worsens or they develop unacceptable side effects.~      Evaluations. Patients come to the clinic for a history and physical examination on day 1 of~     every treatment cycle, then every month for the first two months off therapy, and then at 6~     and 12 months. In addition, they have the following procedures:~        -  Positron emission tomography (PET) scan and neuropsychological testing before starting~          treatment.~        -  Clinical photography (photographic documentation of skin lesions) before starting~          treatment. Patients who do not have cancer have repeat photography at 2 and 8 weeks and~          then, if the lesions shrink or go away while on therapy, again every month for the first~          2 months off sirolimus, then at 6 months and 1 year. Patients who have cancer and~          continue treatment beyond 8 weeks have repeat photography every 8 weeks while on the~          study.~        -  Digital dermoscopy (skin lesion examination using a high resolution camera). This is~          done at the same intervals as clinical photography.~        -  Multiple biopsies of the skin and lower intestine, and possibly the tumor in patients~          with cancer, before starting treatment, at 2 weeks of treatment and at 8 weeks of~          treatment.~        -  Blood and urine tests every week while on treatment for the first two cycles, then every~          4 weeks for patients who continue treatment beyond two cycles.~        -  Imaging studies, such as computerized tomography (CT), ultrasound or magnetic resonance~          imaging (MRI) in patients with cancer before starting treatment and again every two~          cycles to monitor the tumor size and location.~   "
197968|NCT00971776|"~     The AB Portable Driver System will allow patients supported with the Circulatory Support~     System to be discharged home when their medical condition improves to an ambulating status~     and will continue to receive the assistance of the AB 5000 ventricle for their heart~     recovery.~   "
197969|NCT00971763|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cyclophosphamide,~     vincristine sulfate, and prednisolone, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Giving more than one drug (combination chemotherapy)~     together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying giving gemcitabine hydrochloride, cyclophosphamide,~     vincristine sulfate, and prednisolone together with rituximab to see how well it works in~     treating patients with newly diagnosed diffuse large B-cell lymphoma.~   "
197970|NCT00971750|"~     The objective of this study is to prospectively compare laparoscopic ultrasound to~     transabdominal ultrasound for the detection of gallbladder pathology in obese patients~     presenting for laparoscopic gastric bypass. We hypothesize that laparoscopic ultrasound will~     be more sensitive and specific for cholelithiasis than transabdominal ultrasound in morbidly~     obese patients.~   "
197971|NCT00971737|"~     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective~     immune response to kill tumor cells. Biological therapies, such as cyclophosphamide and~     trastuzumab, may increase the number of immune cells and make the immune response stronger.~     It is not yet known whether giving cyclophosphamide together with vaccine therapy is more~     effective with or without trastuzumab in treating patients with metastatic breast cancer.~      PURPOSE: This randomized phase II trial is studying the side effects of giving~     cyclophosphamide together with vaccine therapy and to see how well it works compared with~     giving cyclophosphamide and vaccine therapy together with trastuzumab in treating patients~     with metastatic breast cancer.~   "
197972|NCT00971724|"~     Primary objective:~        -  To identify a biomarker or biomarker-set for the adverse metabolic effects of various~          doses of prednisolone treatment.~      Secondary objectives:~        -  To describe the PK of prednisolone and PD of a series of biomarkers.~        -  To identify biomarkers that reflect side effects of prednisolone.~        -  To elucidate part of the mechanisms by which prednisolone induces metabolic changes.~   "
197973|NCT00971711|"~     Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS.~   "
197974|NCT00971698|"~     The spleen in Sickle Cell Anemia and Sickle Cell Thalassemia is usually enlarged in the first~     years of life but the immune protection provided is considered insufficient. In homozygous~     Sickle cell patients the spleen usually developed recurrent infarcts and after the first~     decade of age become fibrotic. Acute splenic sequestration is also frequent in those patients~     and this is considered as an indication for splenectomy.~      In comparison in Sickle cell thalassemia patients, hypersplenism is more frequent.~      The purpose of this study is to compare the clinical and laboratory issues related to the~     spleen in two groups of Sickle cell patients.~   "
197975|NCT00971685|"~     Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity.~     Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and~     vascular endothelial growth factor (VEGF). The association with dexamethasone increased~     Lenalidomide response rate.~      More recently the efficacy of Lenalidomide has been reported in a patient with POEMS~     (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)~     syndrome with improvement of clinical condition and reduction of vascular endothelial growth~     factor (VEGF) and interleukin-6 (IL-6) level.~   "
197976|NCT00971672|"~     The frequency of iron deficiency anemia was extensively studied in infants on the first year~     of life. There is not enough information about the frequency of iron deficiency during the~     second and third years of life. In a previous study performed in Israel and published in~     Pediatrics 2006 the incidence of anemia does not decrease towards age 18 months. Then there~     is reasonable to study the iron deficiency frequency beyond this age.~   "
197977|NCT00971659|"~     This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or~     a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and~     their effect on blood glucose control, versus insulin glargine alone as active comparator in~     type 2 diabetes.~   "
198025|NCT00971022|"~     The goal of this study is to learn about the factors that influence people to take part in~     discount generic prescription programs.~      The primary objective of this study is to identify the factors associated with awareness and~     utilization of discount generic prescription programs and how two low-income populations in~     Houston utilize the $4 for a 30-day supply or $10 for a 90-day supply, Generic Prescriptions~     Program offered by Kroger, Randalls, Target, Walmart, HEB, CVS, and Walgreens.~   "
197978|NCT00971646|"~     Over the past few years it has become clear that our understanding of bladder physiology is~     inadequate to explain urge incontinence. This has forced us to re-evaluate what we know and~     do not know about bladder function and dysfunction. This has led to the identification and~     study of novel systems within the bladder that may contribute to abnormal sensations.~      The investigators now suspect that the organic changes occurring in the bladder are not the~     whole story. For one group of patients with pathological urge there is growing evidence~     suggesting that there may be a strong psychological component. The idea now being put forward~     is that normal afferent peripheral information is perceived as abnormal and excessive,~     resulting in an increased desire to go to the bathroom: 'perceptual urge'. It is important to~     identify this group of patients since it will direct their treatment towards more cognitive~     approaches. Also, if such a psychological aetiology can be eliminated it would lead to a more~     focused and effective management of peripheral pathology with surgery or pharmacology.~   "
197979|NCT00971633|"~     This study will assess the bioequivalence of a Merck clinical trial formulation of~     ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.~   "
197980|NCT00971620|"~     Cutaneous leiomyomas are benign tumors of smooth muscle origin. They can be very painful, and~     current treatments for the tumors and for the associated pain do not produce satisfactory~     results. One potential treatment for localized severe muscle pain involves injections with~     botulinum toxin A. This study will investigate the effectiveness, side effects, and dosage of~     botulinum toxin A (BOTOX) as a treatment for patients with pain associated with cutaneous~     leiomyomas.~      This study will include 18 subjects, all of whom will be 18 years of age and older, who have~     pain associated with cutaneous leiomyomas.~      For the 24-week study, patients will be randomly assigned to one of two treatment groups.~     Neither the study team nor the patient will know to which group patients have been assigned.~     Before the study begins, all participants must provide a full medical history for research~     and evaluation purposes, fill out pain and quality-of-life questionnaires, and undergo an ice~     test in which researchers will apply ice to the site of the cutaneous leiomyomas and ask~     participants to evaluate the level of pain before and after ice application. Both groups will~     be required to keep a pain diary throughout the study to record their level of pain on a~     daily basis, and will be asked to avoid or restrict the use of specific medications or other~     remedies to treat the pain.~      At the first visit (Week 0), one group will receive a prescribed dose of botulinum toxin A,~     which will be administered as an injection into the leiomyoma, and the other (control) group~     will receive a placebo injection of a saline solution. Patients will return 4 weeks later, at~     which time they will undergo a medical examination, and the ice test, and complete~     questionnaires to assess responses and level of pain. Patients will return in Week 12, at~     which time the group assignment will be revealed (un-blinded) to investigators and patients.~     Patients who received placebo injections will be offered the opportunity to receive injection~     of botulinum toxin A into their leiomyomas. All patients will undergo a medical examination,~     the ice test, complete questionnaires, and continue completing their daily pain diaries at~     home. The final visit, in Week 24, will follow the same procedure as the Week 4 visit.~      At the end of the study, patients may be eligible to have one or more of the painful~     cutaneous leiomyomas surgically removed if the researchers believe that the skin lesions can~     be removed with a reasonable cosmetic result.~   "
197981|NCT00971607|"~     Ischemic postconditioning can reduce myocardial injury following myocardial infarction.~      A potential pharmacological agent is the anesthetic Sevoflurane. The investigators'~     hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will~     reduce infarct size.~   "
197982|NCT00971594|"~     The purpose of this study is to investigate the mechanisms by which physical inactivity and~     obesity alter skeletal muscle insulin signaling to cause insulin resistance and increase the~     development of impaired glucose tolerance (IGT).~   "
197983|NCT00971581|"~     Primary Objective:~      To confirm the safety and tolerability of the fixed dose combination of a Non-Steroidal~     Anti-Inflammatory Drug (NSAID), ketoprofen, associated to a Proton Pump Inhibitor (PPI),~     omeprazole, in Mexican patients.~      Secondary Objective:~      To confirm the efficacy of the combination:~        -  Relief of pain (Visual Analyzed Score (VAS))~        -  Patients global assessment of disease activity, scored as a scale of 1 (no limitation of~          normal activities) to 5 (inability to carried out all normal activities)~   "
197984|NCT00971568|"~     This is a retrospective study of urine samples stored in the Beaumont BioBank for future~     research. The urine samples will be drawn from the urine back with patients previously~     diagnosed with severe interstitial cystitis (IC), mild IC and no IC.~      Interstitial Cystitis (IC) also known as Painful Bladder Syndrome (PBS) is a chronic~     inflammatory disease. It has an unknown etiology, symptoms which present to varying degrees,~     as well as an uncertain natural history. Diagnosis of IC is based on symptoms after excluding~     more common and dangerous pathologies.~   "
197985|NCT00971555|"~     Transient hypothyroxinemia (TH) is a condition characterized by low levels of serum thyroxine~     (T4) and normal levels of thyroid stimulating hormone (TSH). TH in premature infants has been~     found to be related to severity of illness. T4 levels in very low birth weight infants born~     prematurely has been found to be inversely correlated to severity of illness. In very low~     birth weight infants, TH has been associated with poor outcomes. Little is known about~     thyroid function in late preterm infants.~      Hypotheses:~        1. Ill late preterm infants will have lower total T4 levels than healthy late preterm~          infants.~        2. Total T4 and possibly TSH levels will be inversely correlated with short-term outcomes.~        3. Late Preterm infants born by cesarean section will have lower T4 levels compared to~          those born by vaginal birth.~   "
197986|NCT00971542|"~     The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate~     immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new~     swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and~     adolescents. A booster dose will be administered 12 months after the first vaccination.~   "
197987|NCT00971529|"~     Cigarette smoking is the major risk factor for a series of life threatening diseases~     including cancer and heart attack, which causes millions of deaths each year worldwide. Many~     of the harmful effects of cigarette smoking can be reversed by quitting; however, due to the~     addictive nature of nicotine, quitting smoking is extremely difficult. Despite the efforts,~     currently available methods produce only modest smoking cessation rates with relapse.~     Previously, tea components were shown to protect effect against cigarette smoke-induced~     toxicity. Here the investigator reported an unprecedented smoking cessation effect of tea.~     Green tea was made into cigarette filters and tested for its smoking cessation effect in a~     double-blind clinical study. The tea filter could effectively achieve abstinence relapse~     using smoking process to quite smoking and easy to be used by smoker without any side effects~     and psychological obstacles. This work provides a new idea and innovative method to combat~     tobacco epidemic. Its implementation and popularization may make a great contribution towards~     to reducing the smoking-related diseases, and relieving the public health burden and~     pollution caused by cigarette smoking.~   "
198063|NCT00970528|"~     The purpose of this study is to evaluate the efficacy and safety of acarbose in comparison~     with voglibose in type 2 diabetic patients whose blood glucose levels were inadequately~     controlled with insulin glargine alone or in combination with metformin.~   "
197988|NCT00971516|"~     The main goal of this study is to look at the way gums heal around dental implants placed in~     healthy patients compared to patients with type 2 diabetes. This study is designed to answer~     the following questions:~        -  How much swelling occurs around dental implants placed in patients with type 2 diabetes?~        -  Is swelling (inflammation) present or absent in the initial healing phase after~          placement of dental implants?~        -  What are the differences in the amount of swelling (inflammation) in patients with and~          without type 2 diabetes? Are patients with type 2 diabetes more likely to have bone loss~          around dental implants?~   "
197989|NCT00971503|"~     Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute~     a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the~     body's own immune system attacks and destroys the cells that make insulin. Exogenous~     administration of insulin is the primary method of controlling type 1 diabetes by regulating~     blood glucose levels, but this treatment does not reverse nor prevent disease progression.~      Our hypothesis is that when implanting stimulated total bone marrow by arterial injection~     directly into the pancreas, we will achieve functional recovery of insulin-producing cells.~     This study will include patients with chronic type 1 diabetes and absence of lesions in~     target organs. We will follow the evolution of patients receiving autologous total bone~     marrow implantation by selective catheterization and compare to a non-treatment control~     group. All subjects will continue to use insulin therapy as needed to maintain the best~     possible glucose control.~      The objective is to achieve a significant increase in C-peptide levels indicating a~     regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least~     70% of the patients.~      This study is a follow-up to our initial study in which 22 patients received autologous total~     bone marrow. The initial study was 100% safe but additional studies like the one described~     above are needed to show efficacy.~   "
197990|NCT00971490|"~     The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous~     electrical nerve stimulation applied on acupoints) on lung functions and quality of life and~     to explore the associated underlying mechanisms in subjects with COPD.~   "
197991|NCT00971477|"~     The purpose of this study is to determine if an asynchronous online model of teledermatology~     can achieve similar clinical outcomes as compared to conventional in-office care for the~     management of psoriasis. The investigators also aim to determine the effects of this online~     care model on patient quality of life as well as patient and physician satisfaction.~      The investigators' hypotheses include the following:~        1. Compared to in-person visits, the online care model will result in similar clinical~          improvement in psoriasis disease severity.~        2. Compared to in-person visits, the online care model will result in similar improvements~          in quality of life.~        3. Providers and subjects in the online group will achieve a similar level of overall~          satisfaction as those in the in-person group.~   "
197992|NCT00971464|"~     Patients with advanced Age-Related Macular Degeneration will be randomized into one of two~     treatment groups. One group will receive eccentric view (EV) training while the other a~     closed circuit television (CCTV) training for 6 weeks. Reading speed and accuracy will be~     assessed pre- and post- treatment to determine if one treatment is superior to the other.~   "
197993|NCT00971451|"~     Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and~     scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be~     recruited to participate.~      All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior~     to their surgery. Each session will include supervised therapeutic exercises. Subjects will~     be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS)~     during each session or knee joint cryotherapy prior to each exercise session. The~     investigators will measure quadriceps function before and after this 2-week intervention~     (both sessions occur prior to reconstruction surgery). This study will also have a true~     control group that will not receive either exercise of modality intervention. The~     investigators will collect subjective and objective outcomes data at regularly scheduled~     post-operative visits.~   "
197994|NCT00971438|"~     Patients with acute abdominal pain and suspicion of appendicitis are common. The management~     of these patients is controversial with large variations between hospitals. The clinical~     diagnosis is regarded as insufficient necessitating the use of diagnostic techniques like~     ultrasound, computerized tomography and diagnostic laparoscopy. However, the role of these~     diagnostic techniques is not clear.~      This aim of this prospective interventional study is to analyze the impact of the~     implementation of a clinical score to improve the clinical diagnosis and to serve as a basis~     for a structured management of these patients by comparison of the results after the~     implementation of the score with that of a baseline period. In the group of patients with~     indeterminate diagnosis according to the clinical score, the value of diagnostic imaging will~     be evaluated and compared with a period of in-hospital observation by randomization. The~     hypothesis is that a clinical score will decrease the use of unnecessary diagnostic imaging~     and unnecessary admissions to hospital for observation.~   "
197995|NCT00971425|"~     The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals'~     investigational vaccine GSK2340272A.~   "
197996|NCT00971399|"~     The purpose of this study is:~        1. To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced~          nausea and vomiting in the treatment of gastrointestinal cancer.~        2. To verify an improvement of 20% in complete response rate in term of radiotherapy~          induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).~   "
197997|NCT00971386|"~     Heart failure is associated with faster breathing, which has a negative impact on the~     functioning of the heart. This leads to fatigue, shortness of breath, and exercise~     intolerance. It has been shown that when slow breathing technique was taught to patients with~     heart failure, they had a reduction in their sensation of shortness of breath and an~     improvement in their exercise performance.~      The study will compare the short-term effects of controlled slow breathing with biofeedback~     in normal healthy subjects, acute heart failure, and chronic stable heart failure. The~     purpose is to see if there is any change in the objective measurements of heart function~     while breathing at normal rates compared to a controlled slower rate.~   "
197998|NCT00971373|"~     This is a pilot study to determine the effectiveness of antimicrobial scrubs on bacterial~     burden of HCW's hands and clothing in a clinical setting.~   "
198000|NCT00971347|"~     This is a randomized controlled trial of the effects of chewing gum on body weight. The~     investigators will randomly assign 200 overweight or mildly obese adults to one of two~     groups. Participants must be otherwise healthy and ages 19-50. The control group will receive~     only printed information on optimal diet and increasing physical activity. The intervention~     group will be instructed to chew gum following meals and in place of snacks for a minimum of~     90 minutes per day. The intervention group also will receive the same information on optimal~     diet and increasing physical activity as the control group. In this 8-week intervention, the~     primary outcome will be change in body weight, and secondary outcomes will be changes in body~     mass income (BMI), waist circumference, and blood pressure. The protocol includes 3 clinic~     visits to assess outcomes: baseline, 4 weeks after randomization, and 8 weeks after~     randomization. Adherence to the gum chewing protocol will be assessed at clinic visits and~     during 2 telephone calls at 2 weeks and 6 weeks post-randomization. The investigators'~     hypothesis is that gum-chewers will lose more weight than those who receive information only.~   "
198001|NCT00971334|"~     The purpose of this study is to collect samples for the purpose of developing a prenatal~     aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from~     pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by~     chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff~     aneuploid test will be compared to the chromosomal analysis obtained via CVS or~     amniocentesis.~   "
198002|NCT00971321|"~     This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of~     GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35~     months.~      This protocol posting has been updated following protocol amendment 4, March 2010. The~     protocol posting sections impacted are number of subjects, primary and secondary endpoints~     and intervention.~   "
198003|NCT00971308|"~     The purpose of this study is to determine the antiviral effect following three days of dosing~     with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected~     subjects.~   "
198004|NCT00971295|"~     The primary objective was to investigate whether multiple-dose administration of~     eslicarbazepine acetate affects the pharmacokinetics of metformin.~   "
198005|NCT00971282|"~     This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral~     (split-face) comparison.~      The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in~     reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.~   "
198006|NCT00971269|"~     The study is an open, prospective, single-site study where 16 patients suffering from fecal~     incontinence will be included. Change in fecal incontinence episodes after intersphincteric~     injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.~   "
198007|NCT00971256|"~     Review bladder cancer patients and form a database in regards to urine cytology.~   "
198008|NCT00971243|"~     The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination~     with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate~     the safety and efficacy of MP-513 in combination with Metformin with an extension treatment~     for up to 52 weeks.~   "
198009|NCT00971230|"~     This study will evaluate the safety and acceptability of an intermittent and daily PrEP~     regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at~     risk for HIV, and it will directly compare adherence and intracellular drug levels in daily~     and intermittent PrEP recipients. It will also evaluate the relationship between drug~     adherence, sexual behavior and intracellular drug levels with an intermittent PrEP regimen.~     In addition it will evaluate the relationship between adherence to an intermittent PrEP~     regimen and timing of sexual activity in relation to PrEP dosing. The study will use~     objective medication event monitoring medication event monitors (MEMS) adherence measurement~     and evaluate the feasibility of newer adherence measurements such as hair sampling and plasma~     drug levels. The study will also evaluate the feasibility of using SMS (text messages) to~     collect sexual activity data in an African setting. It will allow study teams and communities~     to prepare for potential subsequent larger trials of intermittent PrEP. This study is not~     sized to evaluate efficacy. If the intermittent PrEP regimen is shown to be safe, feasible in~     terms of adherence, and achieves intracellular drug levels similar to daily PrEP, these data~     could be used to design a larger phase 2 study with one or more intermittent PrEP regimens.~     The goal of such a trial would be to provide bridging data if daily PrEP regimens are found~     to be effective or to prepare for efficacy or non-inferiority trials of intermittent versus~     daily PrEP.~      Investigation of immune responses associated with FTC/TDF will also be evaluated in the pilot~     study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due to~     exposures that did not lead to established HIV infection, will be assessed at 2-3 time points~     and compared to responses in volunteers assigned to placebo. Immune responses may be~     correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type.~     As noted above, very few HIV infections are expected to occur during the study, so~     correlation of HIV-specific immune responses and protection from infection or attenuation of~     disease progression will not be possible until a larger study is conducted.~   "
198010|NCT00971217|"~     To date very little research has focused on the mental health of young men. The main aim of~     the proposed research is to explore the effectiveness of a combined exercise and~     internet-based cognitive behavioral therapy (CBT) intervention (called Back of the Net) on~     indices of suicide risk in young men. A second aim is to explore the relationship between~     physical self-concept, self esteem, body fat composition, body circumference and changes in~     depression as a result of an exercise intervention. It is hypothesised that the combined~     exercise and internet-delivered CBT intervention will have greater benefits for indices of~     suicide risk compared to an exercise-only intervention, an internet-delivered CBT-only~     intervention and a control condition.~   "
198011|NCT00971204|"~     This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation~     in the treatment of paroxysmal atrial fibrillation.~   "
198012|NCT00971191|"~     This study will enroll patients who are planned to undergo surgical removal of their tumor.~     The goal of the study is to evaluate the changes that occur in the tumor after brief (about 8~     days) exposure to the study drug.~   "
198021|NCT00971074|"~     The investigators' objective is to analyze a group of patients who have had a partial~     meniscectomy but continue to have knee pain after surgery with a double-blind, randomized~     prospective study comparing the use of Hylan G-F 20(single injection of a~     viscosupplementation) versus placebo injection. The investigators would expect patients who~     receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in~     the placebo group (had the needle injected into the knee but no medication or substance~     injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.~   "
198022|NCT00971061|"~     The purpose of this study is to investigate the efficacy and safety of the Ahmed valve~     implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma~     during a follow-up period of 24 months.~   "
198023|NCT00971048|"~     To compare HP828-101 to standard of care for the management of partial or full thickness~     wounds~   "
198013|NCT00971178|"~     Dexmedetomidine is an alpha 2-adrenoreceptor agonist, which provides sedation, analgesia and~     anxiolysis in clinical practice (Cortinez et al., 2004,Hall et al., 2000). Three types of~     alpha 2-adrenergic receptor subtypes are found in the human body and they have been~     designated alpha 2A, alpha 2B and alpha 2C. The alpha 2A subtype is most likely responsible~     for the analgesic properties of dexmedetomidine in both peripheral and central sites (Kingery~     et al., 2000, Smith et al., 2001). Activation of central alpha 2-adrenoreceptors in the locus~     ceruleus (Correa-Sales et al., 1992) and the dorsal horn of the spinal cord (Gaumann et al.,~     1992b) are responsible for both analgesic and sedative effects. Dexmedetomidine has a very~     high alpha 2 to alpha 1 selectivity, 1620 to 1, or approximately 8 times that of clonidine.~     It is also 4 to 6 times more potent than clonidine by weight (Bhana et al., 2000).~      Although dexmedetomidine produces dose dependent sedation upon intravenous administration,~     its the analgesic effect is of dexmedetomidine is more variable and controversial. In an~     ischaemic pain model in healthy volunteers, a single bolus of dexmedetomidine produced a 50%~     reduction in pain scores when compared to placebo (Jaakola et al., 1991). In another~     volunteer study using the cold pressor test, dexmedetomidine 1 µg/kg over 10 minutes followed~     by an infusion of 0.2 to 0.6 µg/kg/hour reduced pain by approximately 30% (Hall et al.,~     2000). However, when administered as a target controlled infusion at concentrations ranging~     from 0.09 to 1.23 ng/mL, dexmedetomidine had no analgesic effect in human volunteers~     subjected to heat and electrical pain, although sedation was produced (Memis et al., 2004).~      Clonidine and dexmedetomidine are two common alpha 2 agonists used clinically. Although~     clonidine former has been used successfully in regional analgesia and anesthesia (Gabriel et~     al., 2001)., There are only very few studies evaluating the peripheral analgesic effects of~     dexmedetomidine. Since acute postoperative dental pain is a common analgesia model (Cooper,~     1991; US Food and Drug Administration 1992), the investigators conducted this study, aiming~     to assess the postoperative analgesic efficacy of peripheral dexmedetomidine after bilateral~     third molar surgery under general anaesthesia. The analgesic effects were compared up to the~     72nd hour postoperatively in order to evaluate any potential preventive analgesic effect.~   "
198014|NCT00971165|"~     High blood pressure is the major risk factor for Cardiovascular disease (CVD). The prevalence~     of hypertension in Brazil was established in population-based studies conducted in different~     cities and States, varying from 22.3 to 44% of adults.~      The benefit of drug treatment of hypertension to prevent major cardiovascular events was~     consistently demonstrated in a large series of clinical trials controlled by placebo.~      Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well~     tolerated, have longer duration of action and the advantage of very low cost to be used in a~     population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is~     to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized~     by a potassium-sparing diuretic, as amiloride.~      A study comparing diuretic with an ARB agent is therefore recommendable in Brazil, in order~     to support the decisions of the Health Secretary in regard to blood pressure agents supply~     for the Brazilian population. Such a study was demanded and funded by the Health and~     Technology Ministries in Brazil.~   "
198015|NCT00971152|"~     This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where~     a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily~     dose is administered for women who are at risk of a poor ovarian response in order to~     determine if one dose or the other results in improved cycle outcomes.~   "
198016|NCT00971139|"~     This interdisciplinary, international collaboration study, including the the Norwegian Health~     Economy Administration (HELFO) will evaluate the effectiveness and real-world implementation~     of an online patient-provider communication (OPPC) service into rout ine practice. In Phase I~     we will identify patients and care providers requirements and organizational contexts, and~     use participatory design methods to adapt the OPPC service to users needs and the context of~     clinical practice. In Phase II we will offer study participants access to the OPPC service to~     understand implementation issues. In addition, we will conduct a pilot randomized clinical~     trial (usual care; OPPC) with 40 patients in each group that will be followed over 6 months.~   "
198017|NCT00971126|"~     The purpose of this phase I study is to determine the maximal tolerable dose (MTD) of~     thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment~     of advanced or metastatic HCC.~      The Phase II purpose of this study is to determine the disease control rate (complete~     response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®)~     plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic~     HCC.~   "
198018|NCT00971113|"~     The human intestinal microflora is characterized as a complex and dynamic microbial ecosystem~     with crucial contribution to our nutrition and welfare. Health-promoting genera such as~     Bifidobacterium spp. and Lactobacillus spp. play a key role in digestion of nutrients,~     production of short chain fatty acids and vitamins, inhibition of harmful bacteria,~     immunostimulation, reduction of blood cholesterol and ammonia levels and restoration of~     normal flora after antibiotic therapy. Proteolytic species such as toxin-producing clostridia~     and toxigenic E. coli are considered as potential pathogens with detrimental effects to human~     host.~      Recently, part of novel food research is directing towards the concept of prebiotics e.g.~     food ingredients that are not hydrolyzed by the human gastrointestinal tract and beneficially~     affect the host by selectively stimulating the growth and/or activity of one or limited~     number of bacteria in the colon that can improve host health.~      Fructo-oligosaccharides and inulin, are considered as the most extensively studied and~     well-established prebiotics. In vitro and in vivo data suggest the bifidogenic effect of~     inulin and oligofructose, which can be attributed to their selective fermentation by~     Bifidobacterium species. Due to their documented prebiotic properties, both inulin and FOS~     are increasingly applied in novel food product development through the fortification of~     commonly ingested foodstuffs.~      The aim of this study is to evaluate the in vivo prebiotic effect of a functional food~     containing short-chain fructo-oligosaccharides (sc-FOS) and Sideritis euboea extract on the~     faecal microflora composition of healthy human volunteers.~   "
198019|NCT00971100|"~     The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate~     immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new~     swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and~     adolescents. A booster dose will be administered 12 months after the first vaccination.~   "
198020|NCT00971087|"~     The purpose of this image acquisition study is to compare, in a Reader Study, the~     Tomosynthesis System used in conjunction with a conventional 2-D digital imaging system (2-D~     plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to~     determine whether the 2-D plus 3-D images compared to the 2-D images alone will improve~     receiver operating characteristic (ROC) area under the curve.~   "
198024|NCT00971035|"~     This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The~     purpose is to evaluate the relationship between the dose of lebrikizumab and the response in~     terms of the efficacy, safety, and tolerability in patients with asthma who are not on~     inhaled steroids.~   "
198064|NCT00970515|"~     The aim of this study is to compare immediate and long-term (24 months) results of~     laparoscopic and open mesh repair of incisional and umbilical hernia.~   "
198026|NCT00971009|"~     Being diagnosed and treated for cancer is usually associated with severe physical symptoms,~     impaired functional status, complex emotional, psychosocial and existential issues and~     substantial worries. Failure to help patients with their problems and worries can~     unnecessarily delay patients' recovery and rehabilitation, lead to chronic functional~     impairments, anxiety and depression and prolong patients' needs for health care and social~     services. The objectives of this interdisciplinary, international research project that~     includes collaboration with HELFO (The Norwegian Health Economy Administration), are to test~     and compare, in a randomized, controlled trial (RCT), the effects of (1) a~     practice-integrated online patient-provider communication (OPPC) service including access to~     asking questions to HELFO, (2) a multi-component Interactive Health Communication Application~     (IHCA) called WebChoice, and (3) usual care on: patient outcomes, health care and social~     services use and costs. Breast cancer patients undergoing treatment at three different~     hospitals in Norway will be randomized into two experimental and one control groups and will~     be followed with 5 repeated measures over one year. The proposed study will contribute to~     innovative methods and technologies that can radically improve patient-provider~     communication, care quality, and continuity of care. The two interventions tested in this~     study, the OPPC service with and without additional features of WebChoice, represent new~     forms of interactions and information sharing between patients and clinicians where patients~     can get seamless access to communication and information services from where and whenever~     they need it. This could significantly contribute to reducing unnecessary suffering, less~     fragmented health care, better efficiency, patient safety, patient satisfaction and have an~     impact on patients' health services utilization. The investigators' work addresses,~     therefore, important health policy goals with the potential for considerable societal gains.~   "
198027|NCT00970996|"~     The goal of this clinical research study is to find the highest tolerable dose of Abraxane~     (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon~     alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma.~      Primary Objective:~        -  The primary objective of the Phase I is to determine the toxicity, safety and the~          maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin,~          Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.~      Secondary Objectives:~        -  To assess responses to the combination.~        -  To evaluate the duration of response and the overall survival.~        -  To determine the effectiveness in delaying the appearance of Central Nervous System~          disease.~   "
198028|NCT00970983|"~     The purpose of this study is to evaluate the disease free and overall survival of patients~     with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non~     palpable axillary lymph nodes, undergoing either conservative surgery and axillary~     dissection, or a similar treatment for the primary tumor and rapid analysis of the sentinel~     lymph node, the result of which determines axillary node dissection or its avoidance is~     based.~   "
198029|NCT00970970|"~     Von Hippel Lindau disease (VHLD) is an inherited syndrome characterized by vascular~     malformations, kidney cancer, adrenal gland and pancreas tumors. The VHL protein is not~     functional in the different disease associated lesions which results in production of high~     amounts of vascular endothelial growth factor (VEGF). Currently there are no clinical,~     radiographic or molecular markers that can predict the natural history of a given lesion.~     With 89Zr-bevacizumab positron emission tomography (PET) scanning, VEGF can be visualized and~     quantified.~      The investigators hypothesize that 89Zr-bevacizumab PET imaging is a useful tool to predict~     the behaviour of disease associated lesions in patients with VHLD.~      Adult patients with VHLD who have had routine magnetic resonance imaging (MRI) scans of~     central nervous system (CNS) and abdomen will undergo a 89Zr-bevacizumab PET scan. MRI will~     be repeated within 12 months.~   "
198030|NCT00970957|"~     Lack of an effective treatment for macular edema secondary to central retinal vein occlusion~     and the bad response to grid laser treatment in patients with macular edema secondary to~     branch retinal vein occlusion, together with the high incidence of the pathology and the~     great functional loss in the patients that suffer from it has motivated the search for new~     therapeutic approaches.~      In recent times, intravitreal bevacizumab has been tested in clinical practice in small~     series of patients with this pathology, whether as first treatment or after failure of grid~     laser treatment with good functional results in short series.~      However, no retreatment information is available, although preliminary results from published~     series are good.~   "
198031|NCT00970944|"~     This is a controlled trial of amantadine to improve level of function following severe~     traumatic brain injury.~      The purpose of this study is:~        1. To determine whether amantadine hydrochloride, given in a dose of 200-400 mg, improves~          functional recovery from the vegetative and minimally conscious states~        2. To determine whether amantadine-related gains in function persist following drug~          discontinuation~        3. To determine the safety profile of amantadine in patients with disorders of~          consciousness~   "
198032|NCT00970931|"~     The incidence of hypertension in individuals with pre-hypertension was 80% in ten years in a~     study conducted in Southern Brazil. The effectiveness of non-drug interventions to prevent~     hypertension is low in the long term. It may be hypothesized that a population-based drug~     intervention could reduce relevantly the burden of hypertension and cardiovascular disease.~      Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well~     tolerated, have longer duration of action and the advantage of very low cost to be used in a~     population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is~     to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized~     by a potassium-sparing diuretic, as amiloride.~      A study with this objective is therefore recommendable in Brazil, in order to support a plan~     of precocious intervention in individuals with pre-hypertension. Such a study was demanded~     and funded by the Health and Technology Ministries in Brazil.~   "
198033|NCT00970918|"~     The purpose of this study is to obtain the distribution of measurements of the intima media~     thickness of carotid arteries in people with high cardiovascular risk.~   "
198034|NCT00970905|"~     Severe nausea and/or vomiting in patients receiving radiotherapy to the upper abdomen is~     common despite having received pre-medication with ondansetron, a standard preventive~     treatment. This study aims to reduce the incidence of significant nausea and/or vomiting with~     the addition of the NK1-antagonist aprepitant to standard ondansetron treatment. This study~     will also assess the safety and tolerability of prolonged administration of aprepitant over~     the 4 to 6 week period of radiation treatment.~   "
198049|NCT00970710|"~     This study aims to prevent childhood obesity with early life (pregnancy) intensified~     counselling. The recruited intervention group is pregnant mothers who are at risk to get~     gestational diabetes. Lifestyle intervention (nutritional and physical activity) begins~     during pregnancy in maternity clinics and continues in child wellfare clinics until the child~     is 5 years of age.~   "
198099|NCT00970047|"~     Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.~   "
198035|NCT00970892|"~     The investigators aimed to use pharmacogenetic information in clinical practise which may~     lead to rapid, efficient, and safe warfarin dosing in this observational prospective study.~     In this context, the investigators plan to develop an algorithm for estimating the~     appropriate warfarin dose that is based on both clinical and genetic data from the Turkish~     study population. This study is unique not only investigating clinical factors, demographic~     variables, CYP2C9, and VKORC1 gene variations which contribute to the variability among~     patients in dose requirements for warfarin but also including thrombogenic single nucleotide~     polymorphisms (SNP) in the same patient population. Thus, warfarin would be a good example by~     being the first cardiovascular drug for pharmacogenetic guided personalized medicine~     applications.~   "
198036|NCT00970879|"~     The purpose of this study is to evaluate the efficacy of cotrimoxazole prophylaxis in~     prevention of malaria during pregnancy in HIV-infected women, compared to intermittent~     preventive treatment with mefloquine.~   "
198037|NCT00970866|"~     In Ghana, low micronutrient intakes among pregnant women are a major problem. The standard~     nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is low.~     The investigators have pioneered the use of multiple micronutrient-fortified semi-solid~     pastes called Lipid-based Nutrient Supplements (LNS) (made using vegetable oil, groundnut,~     milk, sugar, and micronutrients), and the investigators' previous studies show that the~     approach could have great potential for use by pregnant and lactating women.~      This study aims to evaluate the effects of LNS-P&L designed for pregnant and lactating women~     and LNS-20gM designed for infants. Pregnant women (n=864) randomly selected from ante-natal~     clinics in Yilo and Manya Krobo districts of Ghana will be randomized to receive daily (a)~     Group 1: Iron/ Folic Acid tablets during pregnancy, and a tablet containing calcium (Ca) only~     (akin to a placebo) during lactation (6 mo), (b) Group 2: Multiple Micronutrient tablets~     during pregnancy and the first six months of lactation, or (c) Group 3: LNS-P&L during~     pregnancy and lactation, whilst their infants receive LNS-20gM daily from 6 to 18 months.~     There are two primary outcomes namely:~        1. Maternal primary outcome: Birth length~        2. Child primary outcome: Child length-for-age z-score at 18 mo.~      The investigators hypothesize that a) mean birth length and length-for-age at 18 mo will be~     greater in children whose mothers are in Group 2 than those whose mothers are in Group 1, and~     b) children whose mothers are in Group 3 will have greater birth length and length-for-age at~     18 mo than the children in either of the other two groups.~   "
198038|NCT00970853|"~     Study measures will evaluate cognitive, academic, and behavioral outcomes for the children,~     school services received, and caregiver stress and depression. The main study outcome~     measures include cognitive status, school functioning, and behavior. Long-term outcomes will~     be studied in attempt to verify the 33 and 60 month significant differences found in school~     participation and behavior between the intervention and control groups.~   "
198039|NCT00970840|"~     Inadequate micronutrient intakes during pregnancy, lactation and infancy remain a major~     problem in Ghana. Lipid-based nutrient supplements (LNS) made using vegetable oil, groundnut~     paste, milk, sugar, and micronutrients may offer a solution.~      The proposed study will test the acceptability of a lipid-based nutrient supplement designed~     for infants (LNS-20gM) and another designed for pregnant and lactating women (LNS-P&L).~     Participants will consume a test meal consisting of LNS-20gM (20 infants) or LNS-P&L (20~     pregnant and lactating women) mixed with fermented maize porridge, after which they will be~     given the respective LNS supplement for use at home for 14 d. Primary outcome is the~     proportion of the test-meal consumed. The investigators hypothesize that subjects will~     consume at 75% of the test meal offered.~   "
198040|NCT00970827|"~     Angioplasty is a commonly performed procedure for treating blockage of the blood vessels in~     the heart. Although this procedure is usually successful, it is often accompanied by a small~     degree of damage to the heart (i.e., small heart attack).~      The purpose of this study is to find out if inflating a blood pressure cuff on the arm or the~     leg at the time of angioplasty for several minutes has a beneficial effect.~      Patients will be assigned to one of three treatment groups: inflating blood pressure cuff on~     the arm, inflating blood pressure cuff on the leg and a control group.~   "
198041|NCT00970814|"~     The primary objectives of this study are to assess the efficacy of levetiracetam XR in~     increasing the percentage of subjects with no heavy drinking days and in reducing the weekly~     percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV~     criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more~     drinks per drinking day for women (designated as very heavy drinkers).~   "
198042|NCT00970801|"~     The incidence of pulmonary disease caused by nontuberculous mycobacteria (NTM) has been~     increasing, and a substantial proportion of these patients have no preexisting lung disease~     and no demonstrable immunodeficiency. These patients are predominantly nonsmoking elderly~     women. High-resolution computed tomography scans revealed the characteristic findings of~     multifocal bronchiectasis combined with multiple small nodules. NTMs are ubiquitous~     environmental organisms. Because exposure to these organisms is universal and the occurrence~     of the disease is rare, normal host defense mechanisms must be effective enough to prevent~     the infection.~      All patients with NTM lung disease do not need to receive long-term antibiotic treatment. As~     the American Thoracic Society guidelines point out, one of the most difficult questions may~     be when to start antibiotic therapy in patients with NTM lung disease. The decision to begin~     treatment is made by weighing the anticipated benefits and risks. The decision is relatively~     easy in patients with profound symptoms and destructive lesions; however, the decision is~     difficult in patients with mild symptoms and non-advanced lesions. Factors that must be~     considered include the patients' age, whether the symptoms are mild or equivocal, and the~     presence of comorbidities. In all cases, close observation is necessary if treatment is not~     performed. However, few studies have shown that patients with certain characteristics show~     disease progression.~      The treatment of NTM pulmonary disease depends on the infecting species, but decisions~     concerning the institution of treatment are never easy. Treatment requires the use of~     multiple drugs for 18 to 24 months. Thus, treatment is expensive, often has significant side~     effects, and is frequently not curative. Therefore, clinicians should be confident that there~     is sufficient pathology to warrant prolonged, multidrug treatment regimens. In all of the~     situations, outcomes can be best optimized only when clinicians, radiologists, and~     laboratories work cooperatively.~      This study will examine why some people are more susceptible to NTM lung disease and why some~     people of NTM lung disease are more difficult to treat. This study will examine the patient~     and bacterial characteristics, course of disease and treatment of NTM infections, as well as~     the genetics involved in these infections.~      Patients with diagnosed NTM lung disease may be eligible for this study. All participants~     will have a medical and family history, blood tests, imaging studies that may include X-rays,~     computed tomography (CT) scans, and genetic and serologic studies. The aim of this study is~     to identify patient and bacterial characteristics that contribute to disease susceptibility,~     disease progression, and treatment failure. Subjects are recruited from among patients who~     are diagnosed to have NTM lung disease at the Samsung Medical Center in the Republic of~     Korea.~   "
198043|NCT00970788|"~     A randomized controlled trial of a video decision aid in 50 patients with advanced brain~     cancer.~   "
198044|NCT00970775|"~     This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel~     group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following~     single ascending dose administration to healthy Japanese subjects.~   "
198045|NCT00970762|"~     This study was conducted to determine and compare the safety and effectiveness of two~     neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are~     undergoing general elective surgery with sevoflurane anesthesia.~      Study participants received an intubating dose of a neuromuscular blocker (to enable~     insertion of a tube through the nose or mouth into the trachea to provide artificial~     ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed,~     to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular~     blocker (onset time) after the intubating dose was measured and compared as the primary~     outcome.~   "
198046|NCT00970749|"~     This is an exploratory study in which the investigators will develop a way to identify the~     cell responses most strongly associated with protection against chlamydia infection. This~     study is not driven by a hypothesis.~   "
198047|NCT00970736|"~     The goal of this project is to examine the area of the brain that controls muscle movement~     for a group of muscles important for swallowing, and to see how that area changes over 2~     weeks of time.~   "
198048|NCT00970723|"~     Macular edema remains a major cause of vision impairment in diabetic patients. Its~     pathogenesis is multifactorial and incompletely understood. Systemic factors seam to play a~     role in this pathogenesis, including high blood pressure. The objective of the study is to~     evaluate the effect of an intensified intervention on blood pressure and sleep apnea with~     that of conventional treatment in patients with type 2 diabetes and diabetic macular edema.~   "
198050|NCT00970697|"~     Background: No medical treatment has proved its efficacy for the treatment of hypertensive~     leg ulcers in a well designed trial.~      Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated~     with becaplermin gel (Regranex Gel®) daily application versus the application of the same~     quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin~     gel.~      Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were~     randomized to receive either a daily application of becaplermin gel or hydrogel during 8~     weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.~      Primary aim of the study: Complete closure at week 8~      Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12,~     pain and quality of life during treatment~      Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be~     an alternative medical treatment to the skin graft usually proposed~   "
198051|NCT00970684|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab~     together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel~     and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or~     recurrent non-small cell lung cancer.~   "
198052|NCT00970671|"~     The purpose of this study is to determine whether treatment of fresh surgical scars with a~     pulsed dye laser using purpura-inducing settings will improve clinical appearance better than~     one using non-purpura-inducing settings or no treatment.~   "
198053|NCT00970658|"~     The purpose of this study is to evaluate the efficacy in reducing signs and symptoms in~     patients with contusions, sprains, muscular injuries and injuries with less than 24 hours~     early or holders of myalgia, pain and tendonitis in regions miofasciais articulated with~     Salonsip compared to Sabiá plaster.~      It is clinical, open, multicenter, randomized, prospective and comparative, with patients~     entering at random.~      Patients will be included in sufficient quantity to achieve the minimum number of 70~     evaluable patients.~   "
198054|NCT00970645|"~     This is a prospective randomized clinical trial with the study cohort comprised of all male~     and female patients over the age of 21 presenting to the study site for evaluation of lung~     cancer. The study will enroll 300 subjects, with 150 in each arm. Three sites will be in the~     study, Mayo Rochester, Mayo Jacksonville and Medical University of South Carolina. Mayo~     Rochester will enroll approximately 125 subjects. This study does not require subjects to~     undergo any additional procedures than what they would receive per standard medical care. The~     consenting subjects will receive EUS and /or EBUS- guided FNA or~     Mediastinoscopy/Thoracoscopy.~   "
198055|NCT00970632|"~     The purpose of this study is to determine whether an experimental drug known as tadalafil~     given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia~     (straining, urinary frequency, feeling like your bladder is still full etc.)~   "
198056|NCT00970619|"~     Rationale: Iliofemoral deep venous thrombosis (IFDVT) is associated with significant post~     thrombotic morbidity. The presence of both obstruction and reflux significantly increases the~     chances for development of post-thrombotic syndrome (PTS). Early thrombolysis may reduce the~     incidence of PTS as compared to treatment with conventional anticoagulant medication alone.~     Improvement of the health related quality of life (HRQOL) has been reported after surgical~     clot removal. The investigators hypothesize that such improvements could also be reached~     after catheter directed thrombolysis.~      Objective: To assess whether catheter directed thrombolytic therapy for the treatment of~     IFDVT can safely and effectively reduce post thrombotic morbidity after one year. The~     secondary objective is to study whether catheter directed thrombolytic intervention has a~     positive effect on the quality of life of patients with IFDVT and to assess late PTS.~      Study design: prospective, non blinded, randomized, controlled, multicenter, intervention~     study~      Study population: The study population includes all consecutive patients with IFDVT~     presenting at the emergency or outpatient departments of the participating centres. The~     thrombus should not be older than 14 days at randomization.~      Intervention: After randomization patients will be allocated to either conservative~     anticoagulant treatment or to catheter directed thrombolysis combined with conservative~     anticoagulant treatment.~      Main study parameters/endpoints: The primary efficacy outcome is the incidence of PTS at one~     year; a decline in PTS incidence from 25% to 8% is anticipated. The secondary outcome is the~     Health related Quality of life and late PTS during follow-up. The principal safety outcome is~     major bleeding during anticoagulant therapy. Bleeding as well as events of recurrent~     thrombosis will be monitored. The patency of the venous system of the affected lower limb~     will be assessed as well as the percentage of clot lysis, after thrombolytic intervention.~     Additionally, measurements of markers of coagulation and inflammation will be performed~     during follow-up.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: For patients who are randomized to the intervention arm of the study a hospital~     stay for 24-36 hour is mandatory during catheter directed thrombolysis. All patients will~     undergo additional imaging by MRA-vasovist and air phletysmography (APG) at baseline and~     after 12 months. Clinical follow-up visits will be matching usual care at 3, 6, 12 months;~     blood will be taken at these visits. Health-related quality of life (HRQOL) questionnaires~     will be filled out by all patients at baseline, 3, 6 and 12 months after the event; and once~     a year during the entire study duration. Further treatment will be in accordance with current~     guidelines for antithrombotic treatment. There may be an enhanced risk of bleeding in the~     thrombolysis group. The expected benefit is reduction of PTS from 25% to 8%, together with an~     improved quality of life.~   "
198057|NCT00970606|"~     To assess the efficacy and safety of oral rosuvastatin in patients with suspected or~     confirmed influenza who require intensive care unit (ICU) admission due to respiratory~     distress.~   "
198058|NCT00970593|"~     This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects~     with type 2 diabetes who are taking metformin for their diabetes.~   "
198059|NCT00970580|"~     The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are~     effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.~   "
198060|NCT00970567|"~     The purpose of this study is to investigate individuals with type 1 diabetes who were~     disconnected from their insulin pump and insulin therapy was started again after positive~     ketones (U) in the urine or blood β-hydroxybutyrate.~   "
198061|NCT00970554|"~     Amblyopia is a visual impairment of one eye that results from disuse of that eye during early~     brain development. The standard treatment for amblyopia consists of patching or~     pharmacological penalization of the sound eye. Unfortunately, approximately 50% of amblyopic~     children do not respond to these therapies, with poor compliance being a major factor in~     treatment failure. One new treatment strategy involves patching the sound eye while using a~     telescopic device on the amblyopic eye to magnify the images formed in the amblyopic eye.~     Children were randomized to receive either daily patching of the sound eye for 30 minutes~     only (patching only group), or daily patching of the sound eye for 30 minutes plus~     simultaneous use of a telescopic device by the amblyopic eye during patching (patching plus~     telescope group).~   "
198062|NCT00970541|"~     The purpose of this study is to determine whether Cinnamon from the Cassae Plant is effective~     in the body as insulin could lower blood sugar levels.~   "
198065|NCT00970502|"~     There is no optimal treatment for patients with recurrent head and neck cancer after previous~     radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10~     months. Surgery is not always possible and often cannot remove every cancerous cell. On the~     other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has~     significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal~     complications. Therefore, less toxic and more effective reirradiation regimens are urgently~     needed. There are extensive data from animal studies and preliminary human studies showing~     that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and~     is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of~     EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans~     and appear to have less severe toxicity than conventional chemotherapeutic agents.~   "
198066|NCT00970489|"~     This is a large multi-center study to examine whether peri-operative intake of n-3~     polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial~     fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).~   "
198067|NCT00970476|"~     To determine if arterial stiffness as measured by non-invasive pulse wave velocity can~     predict the response to resynchronization therapy in heart failure.~   "
198068|NCT00970463|"~     To test the hypothesis that both lack and excess of growth hormone (GH) is associated with~     cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and~     after treatment.~   "
198069|NCT00970450|"~     1. Introduction~           Paracetamol, an analgesic prescribed daily, has been in use for more than 50 years.~          Surprisingly, its mode of action is still unclear. One postulated mechanism is the~          reinforcement of descending inhibitory pathways. A recent publication in a human pain~          model raises the question of whether or not Paracetamol acts according to a central~          serotonergic mechanism. Unfortunately, the chosen model was unable to differentiate~          between overall pain, secondary hyperalgesia and allodynia. In particular, secondary~          hyperalgesia and allodynia are central effects.~           The planned study will examine the central analgesic effects of paracetamol on allodynia~          and hyperalgesia by blocking the central effect by adding tropisetron. It will be based~          on an internationally accepted model for the initiation of secondary hyperalgesia, which~          was developed and tested by colleagues in Erlangen.~        2. Study work plan~           This prospective, randomized, placebo-controlled, double-blinded, cross-over trial in 16~          male volunteers will address pain ratings and the area of secondary~          hyperalgesia/allodynia in a human model of electrically evoked pain and compare four~          different treatment scenarios:~             -  Paracetamol 1 g;~             -  Paracetamol, 1 g and Tropisetron 5 mg;~             -  Tropisetron, 5 mg; and~             -  Saline.~           Each volunteer will be allocated to each scenario in a cross-over fashion. Four separate~          treatment trials, at least two weeks apart, will be performed. Each volunteer will be~          familiarized with the stimulation procedure prior to participation.~        3. Ethical considerations~           Informed consent will be obtained from each volunteer. In addition, each volunteer will~          receive remuneration after participating in the study.~           Paracetamol is considered to be a very safe drug in healthy patients. Tropisetron,~          another safe medication, is routinely used in anaesthetic practice as an antiemetic~          drug. Headache, flush and liver parameter elevation are very rare side effects of minor~          importance in our daily clinical work as anaesthetists.~           This pain provoking procedure was developed at the University Erlangen Germany. It is a~          standardized method and has repeatedly received approval by research ethics committees~          internationally. Furthermore, the investigators applied this model to a recent study in~          Basel (cf your decision study protocol 330/07; unpublished data, analysis and writing~          in progress).~        4. Patient number and timetable~           The investigators will examine 16 volunteers and expect the experimental component to~          last 3 months. The investigators plan to complete this study within one year.~        5. Study importance~      The mode of action of paracetamol remains unclear. The investigators think that this study~     will enable them to answer important questions concerning the action of paracetamol. The~     investigators hope that further understanding of this regularly prescribed drug will help us~     to better understand the complex mechanisms of pain.~   "
198070|NCT00970437|"~     The purpose of this study is to compare the efficacy of the Cognitive Behavioural Analysis~     System of Psychotherapy (CBASP) with the non-specific System of Supportive Psychotherapy~     (SYSP)in early onset chronically depressives.~   "
198071|NCT00970424|"~     This study will evaluate the safety and efficacy of dutogliptin in patients with type 2~     diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.~   "
198072|NCT00970411|"~     The purpose of this study is to assess the safety and tolerability of KRN951 administered to~     patients with solid tumors. In the single dose period, patients in each cohort will receive~     one oral dose of KRN951 in the first day, followed by a 6-day rest period during which no~     treatment is received. After that, patients in each cohort will receive one oral dose of~     KRN951 daily over a 21-day treatment period, followed by a 7-day rest period during which no~     treatment is received. Treatment will be continued in the absence of disease progression or~     unacceptable adverse events.~   "
198073|NCT00970398|"~     The specific objectives of this study are to evaluate the effects of bovine milk osteopontin~     added to infant formula on infant growth, health and immune functions.~   "
198074|NCT00970385|"~     This is a multicenter randomized trial evaluating induction treatment with~     VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T~     cell lymphoma.~   "
198075|NCT00970372|"~     The Norwegian Social and Welfare Act of 1992, opened for compulsory commitment of patients~     with serious alcohol and drug problems to inpatient care. Clinical research of compulsory~     committed dual diagnosed patients is to date unavailable and is demanded by the health~     authorities of Norway. Because there has been limited examination/screening and no~     post-treatment research efforts on this group of patients, the investigators have limited~     knowledge of the treatment as well as the patient group. Do compulsory treated patients~     differ from those voluntarily admitted? Does this type of treatment influence the patients'~     motivation to change their behaviour, and does the treatment effort lead to positive outcome~     effects in the long run?~      The primary aim is to acquire new and in depth descriptive knowledge about the compulsory~     treated group of patients according to: Drug dependence, psychiatric and somatic co-morbidity~     and socio-demographic characteristics, and investigate whether the treatment yields the~     intended outcomes in terms of improved substance abuse measures.~      A second aim is to compare the group with a corresponding group of voluntarily admitted~     patients within the same wards. A follow-up interview focusing on motivational issues within~     6 months post treatment to evaluate the long-term results of the treatment is planned.~      A quasi-experimental, prospective case-control study will be conducted. Compulsory committed~     patients in five counties during a two year period, will be compared to a group of~     voluntarily admitted patients. The groups will be compared regarding 1) description and~     screening 2) motivation to change and 3) outcome results after 6 months.~      Both official authorities as well as clinical practitioners would benefit from valid~     Norwegian results and knowledge within this field to form further policies and evidence based~     best practice for this vulnerable group of patients.~   "
198100|NCT00970034|"~     The aim of this project is to determine the morphological criteria of apoptosis in atrial~     tissues of patients with AF versus SR at transcriptome and genomic size.~   "
198101|NCT00970021|"~     Extract from the mushroom Agaricus blazei Murill har been shown to have strong~     immunomodulating properties both in cell cultures, animal models and in humans. Furthermore~     antitumor properties have been shown in animal models, among them in mice with multiple~     myeloma. The investigators now want to investigate the effect of Agaricus as supplementary~     treatment in addition to chemotherapy in patients with multiple myeloma.~   "
198144|NCT00969449|"~     To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen~     sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration~     for 36 hours under fasted conditions~   "
198076|NCT00970359|"~     The purpose of this study is to find out if the drug AZD6244 can improve the radioactive~     iodine uptake by the patient's metastatic thyroid cancer. The investigator will also be~     testing the tumor specimen taken at the time of your surgery for specific genetic changes to~     see if one of them in particular (the BRAF oncogene) makes your cancer more likely to become~     sensitive to radioactive iodine after treatment with the drug.~      The investigators want to find out if AZD6244 helps to increase the entry of radioactive~     iodine into thyroid cancer cells that have spread and are resistant to radioactive iodine~     therapy, especially if they have the BRAF mutation. To measure how much iodine can enter your~     cancer, the investigators will use iodine-124, a different form of radioactive iodine.~     Iodine-124 allows the investigators to measure precisely how much radioactivity can enter the~     cancer cells, whereas iodine-131 does not. The process of scanning with iodine-124 is called~     lesional dosimetry. Iodine-124 is an investigational agent approved by the FDA (Food and~     Drug Administration) for use in this research study.~   "
198077|NCT00970346|"~     Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic~     fibrosis transmembrane regulator protein. As a result mucus stagnation, obstruction and~     plugging take place in the respiratory and gastrointestinal tract, the biliary and pancreatic~     duct, and in the reproductive system. The objective of this study is to determine the safety~     and tolerability of 3 days of daily dosing of OligoG CF-5/20 versus placebo in healthy~     volunteers.~   "
198078|NCT00970333|"~     Ultimately a marker of microglial activation could be used for large-scale quantitative brain~     imaging trials in Alzheimer Disease (AD), Parkinson Disease (PD) or Multiple Sclerosis (MS),~     specifically to investigate the agent as an objective biomarker in treatments aimed at~     reducing inflammatory changes in these conditions. The significance of this work lies in~     applying state-of-art quantitative neuroimaging tools to develop a relevant biomarker in~     individuals with neurodegenerative diseases with the intention of using this efficiently in~     large clinical imaging trials.~   "
198079|NCT00970320|"~     Traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary~     and anal incontinence, particularly in primiparas.~      The efficacy of pelvic floor muscle exercise (PFME) in treating urinary incontinence (UI)is~     well documented, however, to date there is little evidence to support the efficacy of PFME in~     treating symptomatic anal incontinence.~      This project consists of three separate studies. The prevalence survey/ study (1),~     investigates the prevalence of symptomatic anal incontinence among primiparas at Ostfold~     Hospital Trust Fredrikstad, Norway and St Olav's Hospital, Trondheim University Hospital,~     Norway, and the results in this study will form the basis of the two identical randomized~     controlled trials (RCT) investigating the treatment efficacy of PFME two groups of postpartum~     women. Women reporting symptomatic anal incontinence at six months postpartum (2) and women~     who have sustained a traumatic 3rd or 4th degree tear of the sphincter ani muscles during~     delivery (3), respectively, are randomized to an intervention group receiving PFME treatment~     for six months, or a control group. All RCT participants will undergo examination of PFM~     strength and activity, as well as anal ultrasound prior to randomization and after the~     intervention period.~   "
198080|NCT00970307|"~     This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A~     vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A)~     vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.~   "
198081|NCT00970294|"~     Limited participation in health promotion activities is noted in people with diabetes, even~     though lifestyle changes have been found to be essential in decreasing the risk of~     complications of the disease. The purpose of this study is to gather preliminary data to~     assess the feasibility of an intense, customized health promotion program in people with~     diabetes, and to evaluate outcome measures following participation to determine effect size~     for future studies. Subjects with type 2 diabetes will participate in a 10-week health~     promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic~     and strength training exercises with a schedule of progression, individual nutrition~     counseling, and diabetes health education sessions.~   "
198082|NCT00970281|"~     The primary objectives of the study is to confirm if the efficacy of intramuscular injection~     (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with~     acute psychotic agitation is greater than intramuscular placebo by comparing changes from~     baseline to 2 hours after the first IM injection of agitation.~   "
198083|NCT00970268|"~     The purpose of this extension study is to evaluate the long-term safety, tolerability, and~     efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe~     chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a~     52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week~     lead-in study. All patients will be randomized from the lead-in study at one of two doses of~     aclidinium.~   "
198084|NCT00970255|"~     Upper lingual frenulum have been implicated as a cause for pain during breastfeeding and~     latch problems. The investigators hypothesize that performing frenotomy of the frenulum may~     improve breastfeeding. The investigators will include breastfeeding infants with pain or~     latch problems in whom the lingual frenulum had been treated but breastfeeding problems were~     not resolved. The investigators plan to study the effect of frenotomy of the upper lingual~     frenulum on maternal pain (using pain score by visual analog scale) and/or latch score.~   "
198085|NCT00970242|"~     Ambulatory Urodynamic measurement on patients with diminished or absent bladder contractility~     before and after trial with Sacral Neuromodulation therapy.~   "
198086|NCT00970229|"~     The underlying goal of this study is to assess [123I]MNI-420 SPECT imaging as a tool to~     detect A2aR density in the brain of PD and HD research participants to be compared with~     similarly aged healthy subjects.~   "
198087|NCT00970216|"~     The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of~     telbivudine by maintained suppression of hepatitis B virus (HBV) DNA (<=300 copies/ml or~     60IU/ml, undetectable by current polymerase chain reaction (PCR) - based assays) in HBeAg~     positive/negative patients at physician's general practice.~   "
198117|NCT00969813|"~     This study is designed to evaluate how CP-690,550 is handled by the body in healthy~     volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with~     normal hepatic function. This study will also evaluate the safety and tolerability of~     CP-690,550.~   "
198088|NCT00970203|"~     This study will evaluate the feasibility, safety, and efficacy of intradermal vaccination of~     prostate cancer patients with alpha-type-1-polarized dendritic cells (DC1) loaded with~     apoptotic allogeneic tumor (LNCap). The study will target men with recurrent prostate cancer,~     who failed local therapy, have no measurable metastasis, but have a rising PSA with a~     doubling time of less than 10 months. The selection of this study group enables us to~     evaluate time to PSA progression, a highly relevant, clinical primary endpoint of efficacy in~     this two arm study. In order to facilitate infiltration of vaccination-induced T cells into~     tumor site(s) and to reduce tumor-specific tolerance, subjects will receive the vaccine in~     combination with limited androgen ablation (AA) with a LHRH analogue for 3 months. Subjects~     will be randomly assigned to one of two cohorts. In cohort A subjects will be first treated~     with limited AA alone for 3 months, and at the time of PSA relapse (PSA ≥ 1 ng/dL) will~     receive the DC vaccine in conjunction with AA. In cohort B, the sequence of treatment will be~     reversed. Efficacy will be estimated as the within-subject difference in time to PSA relapse~     following the combination treatment as compared to the AA alone, thus, each subject will~     serve as his own control. All subjects will commence the DC1-based vaccination 2 weeks prior~     to treatment with the LHRH analogue. Each subject will receive 1 intradermal (i.d.) dose of~     the vaccine at weeks 1, 5, 9, and 13 for a total of 4 doses. Additional courses of~     vaccination may be administered to subjects without evidence of disease progression every 3~     months (±1 month) for up to 12 months depending on the number of doses originally produced~     and available after the 4 intended protocol doses. All doses of the vaccine will be~     administered intradermally (i.d.).~   "
198089|NCT00970190|"~     The study examines the biochemistry underlying human olfaction in both normal and diseased~     states.~      The study aims are: 1. to determine the levels of cAMP in olfactory tissue from people with~     chronic rhinosinusitis and other nasal disorders. 2. to correlate preoperative olfactory~     function with cAMP levels from biopsied olfactory tissue. 3. to determine odorant and~     pheromone-mediated activation of cultured human olfactory sensory neurons using calcium~     imaging and 4. to determine odorant and pheromone-mediated activation of cultured human~     olfactory sensory neurons using smell-chip technology.~   "
198090|NCT00970177|"~     This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate~     immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new~     swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly~     subjects. A booster dose will be administered 12 months after the first vaccination.~   "
198091|NCT00970151|"~     The hypothesis of this study is that maternal and fetal biologic variation in the balance~     between pro-inflammatory and anti-inflammatory mediators can be measured by currently~     available techniques. In addition, the investigators hypothesize that a pro-inflammatory~     maternal phenotype increases the risk of fetal exposure to intrauterine hyperthemia and~     inflammatory cytokines; and that intrapartum events, especially known risk factors for fever~     at term such as epidural analgesia and prolonged rupture of membranes, may interact with~     underlying maternal factors to increase fetal exposure to inflammatory cytokines.~      This experiment aims to establish the first large-scale cohort to evaluate biomarkers for~     maternal and fetal inflammation in term pregnancy and to elucidate the relative antepartum~     and intrapartum contributions to fetal inflammation.~   "
198092|NCT00970138|"~     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor~     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The~     investigators' phase I study has shown that the drug's toxicity is manageable and the maximum~     tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib~     can improve progression free survival compared with placebo in patients with metastatic~     gastric carcinoma who failed two lines of chemotherapy.~   "
198093|NCT00970125|"~     The purpose of this study is to study whether preferences for the goals of care for 80~     subjects with end-stage cancer are altered after viewing a video outlining the goals of care~     compared to their initial preferences after hearing a verbal description of the goals of care~     alone.~   "
198094|NCT00970112|"~     The purpose of this study is to investigate whether preemptive medication with dexamethasone~     or etoricoxib provides better pain management and control than placebo following periodontal~     surgery.~   "
198095|NCT00970099|"~     The study is designed to test the following primary hypothesis:~        -  Aerobic exercise training will improve insulin sensitivity in insulin resistant subjects~          through changes in the major cellular signaling pathways and and/or their regulators.~      Accordingly, the proposed study is designed to accomplish the following specific aims:~        -  Quantitate how exercise training improves insulin sensitivity and decreases~          cardiovascular risk factors in a general population of lean, nondiabetic, insulin~          resistant subjects. Effects on known cardiovascular risk factors including blood~          pressure and serum lipoproteins will be evaluated. Change in regional adiposity will~          also be measured~        -  Determine the effects of a program of regular aerobic exercise on in the insulin~          receptor signaling pathway. Biopsies of vastus lateralis muscle from insulin resistant~          subjects will be obtained before and after a hyperinsulinemic glucose clamp. This~          procedure will take place in the untrained state and after exercise training. The~          investigators will measure changes in the insulin receptor and the activity of the major~          components of the intracellular insulin signaling pathway. The investigators will also~          look intracellular proteins that regulate this signaling pathway.~   "
198096|NCT00970086|"~     For surgery in the region of the lower abdominal wall the administration of local anesthetic~     drugs in the epidural space via the caudal route is the preferentially used technique since~     several decades.~      The transversus abdominis plane (TAP) block features the advantages of a peripheral nerve~     blockade. The aim of this study is to evaluate potential differences in the effectiveness of~     postoperative analgesia and to test the hypotheses that the duration of pain relieve ist~     prolonged after a TAP block when compared with an epidural technique.~   "
198097|NCT00970073|"~     This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed~     start of the anti-rejection drugs (10 days after liver transplant), compared to the current~     approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2~     days after the liver transplant.~   "
198098|NCT00970060|"~     The purpose of this study is to describe the effect of a 10-week exercise program on nerve~     function and number of nerve fibers in the skin in the lower leg in people with diabetic~     neuropathy.~   "
198102|NCT00970008|"~     In 2004, we conducted a pilot randomized, wait list controlled, trial (RCT) of massage~     therapy for OA of the knee in 68 subjects. That study, supported by CDC grant SIP-14-00,~     revealed the potential efficacy of Swedish massage therapy in the treatment of OA of the~     knee, with benefits of increased function and decreased pain persisting at least eight weeks~     following treatment cessation. The results of that trial, the first RCT of massage for OA,~     were published in the Archives of Internal Medicine in 2006 (See reference in More~     Information section). This current project builds on the design and findings of the pilot~     trial to determine the optimal dose and treatment regimen and provide longer term follow up.~     This project is a dual-site, randomized, dose-ranging trial to compare four dose/regimens in~     order to identify the optimal protocol for clinical practice.~      The primary study hypothesis is that an eight (8) week course of Swedish massage therapy of~     one of the four proposed doses (by frequency and duration of massage treatment session) will~     be effective in reducing pain and improving function in patients with confirmed OA of the~     knee.~   "
198103|NCT00969995|"~     Migraine is prevalent in 10-12% of the population. It involves the development of a cranial~     perivascular neurogenic inflammation. Recent information suggests that migraine might be a~     risk factor to stroke. The possible mechanisms that might relate migraine and stroke are: 1.~     Migraineous infarction 2. A primary endothelial disorder. 3. Genetic relation 4. An ongoing~     inflammatory process. C reactive protein (CRP) is a sensitive marker for an inflammatory~     process.The data on the relation of migraine to inflammation is limited. The aim of the~     current study is to assess inflammatory factors as possible markers for migraine.~   "
198104|NCT00969982|"~     The primary goal of this study is to determine the clinical advantage of pre-treatment with~     mifepristone in second trimester misoprostol induction abortion. This will be a randomized~     controlled double-blinded trial of 120 women in each country comparing misoprostol alone to~     mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.~   "
198105|NCT00969969|"~     This study will evaluate whether Cartiva is an effective treatment for individuals with~     osteoarthritis of the great toe.~   "
198106|NCT00969956|"~     Diabetes causing serious complications is well known. In this study the aim is to follow 950~     patients with diabetes for 15 years to study when, in who and how the diabetes complications~     occurs.~   "
198107|NCT00969943|"~     The purpose of this study is to evaluate whether men and women respond differently to seeing~     items related to cocaine use or to remembering stressful events. Four groups of individuals~     will be recruited to participate in this study: men with cocaine dependence, women with~     cocaine dependence, men without cocaine dependence, and women without cocaine dependence.~      Hypothesis #1: Cocaine-dependent women will demonstrate smaller increases in neuroendocrine,~     but greater increases in heart rate and more cocaine craving and subjective distress when~     exposed to stress as compared to cocaine-dependent men and non cocaine-dependent men and~     women.~      Hypothesis #2: Cocaine-dependent men will demonstrate greater increases in neuroendocrine,~     but greater increases in heart rate and more cocaine craving and subjective distress when~     exposed to cocaine-related cues as compared to cocaine-dependent women and non~     cocaine-dependent men and women.~      Hypothesis #3: Cocaine-dependent women will demonstrate greater increases in heart rate and~     more cocaine craving and subjective distress when exposed to stress inducing stimuli as~     compared to their own responses to a cocaine-related cue.~      Hypothesis #4: The neuroendocrine response to a stress hormone (corticotropin releasing~     hormone; CRH) will be greater in cocaine-dependent women as compared to cocaine-dependent~     men.~   "
198108|NCT00969930|"~     This is a genetic association study of cognitive impairment in young bipolar disease type I~     patients without medications in mania, depression, hypomania or mixed states.~   "
198109|NCT00969917|"~     The primary objective of the study is to determine the safety profile and overall response~     rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.~   "
198110|NCT00969904|"~     Studies suggest that N-acetylcysteine (NAC) potentially reduces inflammation and~     hyperinflation in patients with COPD.~      In this pilot study the efficacy, safety and tolerability of high dose NAC in 12 patients~     with moderate COPD will be examined. These patients will receive a placebo for 12 weeks and~     NAC for 12 weeks in a dosage of 3 times 600 mg a day on top of their usual medication in a~     randomized crossover design. All subjects will be followed for 28 weeks.~      The effect of high dose NAC on small airways will be assessed by measuring the total and~     peripheral airway resistance calculated with Computational Fluid Dynamics (CFD). The effect~     on oxidative stress will be assessed by measuring exhaled NO and specific markers (CRP,~     erythrocyte sedimentation rate, IL-6, 8-isoprostane, H2O2, TNF-alfa, glutathione, GPX, SOD~     and IL-8) in blood and Exhaled Breath Condensate (EBC). Dynamic and static lung volumes will~     be assessed by spirometry, body plethysmography and diffusion. Quality of life and symptoms~     will be assessed by the St George Respiratory Questionnaire.~   "
198111|NCT00969891|"~     The present study is not hypothesis driven but will explore the ability of~     pharmacokinetic-pharmacodynamic modelling to predict optimal dosage of the chemotherapeutic~     drugs used in therapy in adult patients with acute myeloid leukemia.~   "
198112|NCT00969878|"~     The purpose of this study is to test the efficacy of a newly developed active vaccine against~     cocaine (TA-CD).~   "
198113|NCT00969865|"~     This study will evaluate the effectiveness of an individualized approach to diagnosing and/or~     treating atherosclerosis. This will be done by combining genetic information, lifestyle~     information, participant education, and imaging tests to track diagnoses, therapies, and~     treatment on two groups: 1) Standard Management Group (diagnosed and/or treated according to~     standard of care) and 2) Individualized Management Group (standard of care plus genetic~     testing and coronary artery calcium scans).~   "
198114|NCT00969852|"~     This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline~     with [11C] sertraline positron emission tomography (PET) study.~   "
198115|NCT00969839|"~     This post-market clinical study is being done to evaluate the use of the NovaLign™~     Intramedullary Fixation System in the treatment of humeral fractures.~   "
198116|NCT00969826|"~     This study is a four arm, parallel study.~      Ten were administered a single subcutaneous administration of 30, 100 and 300 μg/kg of GCPGC~     or placebo for each group (active:placebo=8:2). Eight were administered a single subcutaneous~     administration of 100 μg/kg of Neulasta (an active comparator).~   "
198118|NCT00969800|"~     This study is to test whether a chlorine dioxide gas-generating device, which releases a low~     concentration gas of chlorine dioxide in a sustained manner, can protect against respiratory~     infections in elderly individuals living in nursing homes. Such a device is used as a~     deodorant for normal domestic purposes. The investigators reasoned that the antiviral and~     antibacterial properties of chlorine dioxide might lead to a lowering in the incidence of~     respiratory infectious diseases. The study is designed as a randomized placebo-controlled~     double-blind crossover multicentre trial involving approximately 1500 subjects.~   "
198119|NCT00969787|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.~   "
198120|NCT00969774|"~     Introduction:~      Human face with its bony and muscular structures has singular and peculiar characteristics.~     It may be classified in three types, associated with the variation of shape and craniofacial~     configuration, both in vertical and horizontal planes, directly affecting dental occlusion,~     face harmony, orofacial musculature and oral functions. Aim: to correlate cephalometric with~     anthropometric and facial analysis findings on determining the facial type.~      Method:~      105 leukoderm adults were involved, 34 male and 71 female aging between 20 and 40 years old.~     Data were collected in December 2006 in an orthodontic clinic located at Belo Horizonte- MG,~     Brazil. Cephalometric findings to determinate facial types were compared to seven~     anthropometric facial measurements, three anthropometric facial proportions and three~     anthropometric facial indices, in addition to facial type identification through clinical~     facial analysis of photographs.~   "
198121|NCT00969761|"~     The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI~     6727 therapy in terms of drug-related adverse events when combined with a platinum therapy~     (cisplatin or carboplatin).~      Secondary objectives are the collection of overall safety and antitumour efficacy data and~     the determination of the pharmacokinetic profile of BI 6727 combination treatment with~     cisplatin and carboplatin.~   "
198122|NCT00969735|"~     This is a prospective single-center randomized trial comparing the efficacy and safety of PV~     cryoablation with the Arctic Front® catheter versus the standard PV isolation using~     radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated~     from a clinical point of view and from the detection and quantification of AF episodes by~     means of the Reveal XT® implantable loop recorder.~   "
198123|NCT00969722|"~     This is a multicenter, randomized, controlled, open-label study. Patients meeting~     inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus~     GM-CSF or RA plus GM-CSF. Patients who do not respond to their assigned treatment after two~     cycles may cross-over to receive the alternate treatment. Disease response and safety will be~     assessed in all patients after cycle 2 and after cycle 4.~   "
198124|NCT00969709|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major~     depressive disorder.~   "
198125|NCT00969696|"~     To evaluate galantamine's effects on cognitive performance in marijuana users. Galantamine,~     an acetylcholine esterase inhibitor, is approved for treatment of Alzheimer's disease.~     Current marijuana users show impaired cognitive functioning, which predicts poor treatment~     response to behavioral treatments in this population. Whether cognitive impairment in~     marijuana users will improve with medication treatment has not been evaluated. We hypothesize~     that galantamine, compared to placebo, will improve cognitive performance in marijuana~     users.Galantamine, compared to placebo, will improve working memory, verbal learning/memory~     and response inhibition functions in marijuana users.~   "
198126|NCT00969683|"~     Most teams use a left double-lumen tube. The double-lumen tube is available with or without a~     carinal hook. The hook is supposed to facilitate the positioning of the tube and avoid the~     mobilization of the tube during surgery. The use of double-lumen tubes with a hook is large~     in Europe and quite unknown in US. The literature is poor, containing only few case reports.~      The purpose of this research is to compare the two types of left double-lumen tube.~   "
198127|NCT00969670|"~     Samples of sputum from asthmatic children, between 5-17 years, will be collected during two~     years of the study period to perform tests Particle Size Distribution (PSD) and Shape~     Analysis (SA) of the particulate matter in the sputum and a biochemical reaction to evaluate~     the activity of Heme Oxygenase-1 protein in sputum cell supernatants.~      Each child will perform Pulmonary Function Testing (PFT) and Induced Sputum (IS) as a routine~     part of diagnosis of asthma.~      Parents will be asked to complete a questionnaire including questions on their child's~     respiratory symptoms in the last 12 months as well as socioeconomic factors. Parents will be~     asked to give informed written consent for their child's participation in the study.~   "
198128|NCT00969657|"~     Background of the study:~      Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in~     individualizing treatment strategies, i.e., selecting patients who need less invasive surgery~     or another radiotherapy strategy instead of resection. For rectal cancer it is known that~     10-30% of the patients will respond with a pathologic complete response (pCR) after CRT. From~     a retrospective study with multivariate analysis of both clinical and 2-[18F]~     fluoro-2-deoxy-D-glucose and positron emission tomography (FDG-PET) data, it was found that~     adding FDG-PET data collected before and after CRT leads to a more predictive model compared~     to evaluating only pretreatment clinical data. To validate this model, this registration~     study is proposed. Furthermore, it has been found that FDG-PET during treatment is very~     predictive for response and a more favorable time point to adapt treatment. Also, there are~     indications that adding blood biomarkers to the data, results in higher accuracy for response~     prediction compared to clinical and imaging data alone. Therefore, FDG-PET during treatment~     and blood sampling are included in the protocol to improve the accuracy of the prediction~     models.~      Objective of the study:~      The long-term research objective is to be able to select rectum cancer patients who could~     receive a less invasive treatment. If prediction of response is possible, surgery may be~     avoided when complete response after chemoradiotherapy is expected or performed with smaller~     incisions if stage reduction is significant. This support decision system helps to~     individualize patient treatment and can improve the quality of life for the patient.~      Study design:~      28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1 PET-CT scan~     Before radiotherapy, on day 15 and 8 weeks after radiotherapy: blood sample taken.~   "
198129|NCT00969644|"~     Observations in patients with growth hormone (GH)-disturbances have suggested that GH/IGF-I~     might have anti-inflammatory effects. To elucidate this hypothesis the investigators have~     planned a study to investigate if 3 weeks administration of GH and subsequently the GH~     antagonist Pegvisomant (or vice versa) influence serum levels of different inflammatory~     markers in healthy volunteers.~   "
198130|NCT00969631|"~     The purpose of this study is to compare and determine the efficacy of combined metformin and~     Clomiphene citrate administration to that of laparoscopic ovarian diathermy (LOD) in~     infertile women with Polycystic ovary syndrome (PCOS) not responding to treatment with~     Clomiphene alone.~   "
198132|NCT00969605|"~     Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as~     pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows~     promising results mainly in post-cardiac surgery patients. The aim of this randomized~     controlled study was to test the hypothesis that weaning with ASV could reduce the weaning~     duration in patients with chronic obstructive pulmonary disease (COPD) when compared with~     PSV.~   "
198133|NCT00969592|"~     The purpose of this study was to compare the pharmacodynamics (course of the blood~     glucose-lowering effect and duration of effect) and pharmacokinetics (course of the~     concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg~     of insulin glulisine and insulin aspart in a direct head-to-head comparison during two~     euglycemic glucose clamps in healthy subjects.~   "
198134|NCT00969579|"~     This study will describe the perceptions of support and distress outcomes of single/lone~     parents of a child with cancer.~      Background:~        -  Parents and families of children with chronic illnesses have stressors, including~          financial stress, role strains, separations, and interruptions in daily routines and~          plans for the future. All of these experiences may lead directly and indirectly to~          parental stress.~        -  The number of families headed by single or lone parents is increasing. Little work has~          been done to better understand if the needs of parents who are providing care for a~          child on their own differ from parents who do not classify themselves as lone.~          Identifying parents who may need additional support within a pediatric oncology setting~          is very important so that appropriate support is provided.~      Objectives:~      - To better understand the social, emotional, and practical effects of lone parents on~     children with cancer.~      Eligibility:~        -  All parents whose child has been diagnosed with cancer between 6 and 18 months before~          enrolling on the study.~        -  Participants must be able to speak and read English~      Design:~        -  Parents will be asked to complete a questionnaire during one of their child s clinic or~          hospital visits.~        -  The questionnaire will ask about the parenting experience since the child was diagnosed~          with cancer. It will ask about the support the parent has received from family and~          friends since the diagnosis.~        -  The questionnaire will take approximately 20 minutes to complete.~   "
198135|NCT00969566|"~     It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose~     levels in both fasting and postprandial states and preserves pancreatic beta cell function in~     patients with type 2 diabetes. Their mechanism of action is derived from increased incretin~     (GLP-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit~     glucagon secretion from pancreas. Recent studies reported that combination therapy with~     DPP-IV inhibitors and metformin have additive or synergistic effects in lowering glycose~     level, preserving beta-cell mass and function as well as enhancing insulin sensitivity.~     However, there have been few studies about the difference of glucose lowering effect of~     combination therapy of DPP-IV inhibitors and metformin according to the secretory capacity of~     pancreas.~      The researchers hypothesized that combination therapy with DPP-IV inhibitor and metformin may~     have more favorable glucose lowering effect in type 2 diabetic patients who have preserved~     pancreatic secretory function. The researchers plan to investigate the difference of glucose~     lowering effect of 24 weeks treatment with sitagliptin (DPP-IV inhibitor) in combination with~     metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.~   "
198136|NCT00969553|"~     The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI~     6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse~     events.~   "
198137|NCT00969540|"~     Sleep quantity and quality can be influenced by the type of mattress used. This study is~     being done to see if a mattress cover with optically active particles can help back pain and~     improve sleep quality.~   "
198138|NCT00969527|"~     The purpose of the study is to assess the efficacy of Oncoxin+Viusid administration in the~     treatment of rheumatoid arthritis. The duration of this double-blind placebo controlled phase~     3 clinical trial will be 12 weeks. The estimated number of persons with rheumatoid arthritis~     to be recruited and randomized for the study is 86. The primary outcome measure: DAS28 score~     will be assessed at the end of the study.~   "
198139|NCT00969514|"~     Robotic cystectomy is a relatively new procedure previously described only at university~     centers. These studies have all been reviews of single surgeon's experiences.~   "
198140|NCT00969501|"~     The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an~     improvement in pain levels and range of motion.~   "
198141|NCT00969488|"~     Nearly 20% of women do not return to their pré-gestacional body weight. The purpose of this~     study is to investigate the effect of diet and socio-demographics factors during gestation~     and postpartum period to body weight change after delivery. This is a clinical trial with 180~     women interviewed at 1 (baseline), 2, 3, 4, 5 and 6 months postpartum. The dietary data were~     obtained by employing the Food Consumption Frequency Questionnaire with reference to the~     first and sixth months of postpartum.~   "
198142|NCT00969475|"~     The purpose of this study is to determine if fractional carbon dioxide laser treatment of a~     fresh wound at the time of surgery, decreases scar formation. Scar revision is commonly done~     at 6-10 weeks following surgery. Therefore, it may be more beneficial, for both the patient~     and physician, to perform scar revision at the time of surgery.~   "
198143|NCT00969462|"~     In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL)~     treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of~     alopecia may predict for a poor response to treatment [complete remission (CR) rate 79%~     versus 31%, P < 0.0005, respectively]. Also, patients without alopecia had fewer episodes of~     either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose~     reduction [88% vs. 62.5%, P=0.05, for the presence of at least one of them].~      One of the explanations for this phenomenon is related to a lower systemic exposure of~     chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient~     variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic~     exposure and the degree of myelosuppression.~      In a pilot study on 18 patients the investigators could not find the previous association~     between alopecia, response to chemotherapy and bone marrow depression. However, when~     analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC~     (area under the curve) and 3 fold lower peaks (p=0.06). The investigators' lack to approve~     the previous findings might be explained by the small study group.~   "
198145|NCT00969436|"~     The purpose of this study is to assess non-inferiority of two different vaccination regimens~     using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and~     one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™~     administered at 9 months of age followed by concomitant administration of Priorix™ with~     Varilrix™ at 15 months of age in a measles endemic environment such as India.~   "
198146|NCT00969423|"~     The study will investigate characteristics of chronic pain after VATS surgery with two~     different sizes of videoscopic equipment.~   "
198147|NCT00969410|"~     A pharmacodynamic study to evaluate the effect of AV-299 on exploratory pharmacodynamic~     markers in subjects with advanced solid tumors who have liver metastases.~      To evaluate safety and tolerability of AV-299 administered IV in subjects with advanced solid~     tumors who have liver metastases.~   "
198148|NCT00969397|"~     The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser~     therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL)~     therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.~   "
198149|NCT00969384|"~     Aim of the study: To investigate if the intervention described in this protocol has an effect~     on patients' and staff's physical health.~      Null hypothesis: There is no difference in waist circumference, body weight, quality of life~     and the rate of polypharmacy between the intervention and control groups after six months.~   "
198150|NCT00969371|"~     The purpose of the following clinical protocol is to evaluate the safety and effectiveness of~     the Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) for the protocol~     inclusion/exclusion criteria.~   "
198151|NCT00969358|"~     Fast track programs, multimodal therapy strategies, have been introduced in many surgical~     fields to minimize postoperative morbidity and mortality. This study is intended to evaluate~     a rehabilitation program in comparison with a historical series.~   "
198152|NCT00969345|"~     The decreases of physiological capacities which take place with senescence include~     diminishing respiratory capacity as well as a reduction of heart rate variability and~     baroreflex sensibility. Altogether, these alterations increase elderly people's frailty and~     have a negative impact over quality of life. Since Yoga (Indian auto-discipline) has a wide~     range of respiratory exercises already investigated as components for non-pharmacological~     treatments for hypertension (situation in which heart rate variability is also diminished),~     the investigators hypothesis is that the training of respiratory exercises of Yoga may have a~     significant positive effect on heart rate variability and baroreflex of health elderly~     subjects, increasing quality of life and reducing frailty.~      We included 30 health elderly subjects (both sexes, from 60 years-old onwards) divided into 2~     randomized experimental groups: control (C) and respiration (R). Each group underwent an~     entry evaluation, followed by a 4-months training period, after which they were re-evaluated.~     Control consisted of 2 stretching classes per week, and respiration consisted of 2~     respiratory exercises classes a week. Both groups were instructed to perform the exercises at~     home twice a day, and to keep a record of each session in a log sheet. Evaluations were:~     WHOQOL-OLD questionnaire for quality of life, 20 minutes of seated rest with heart rate,~     respiration and blood pressure acquired continuously for further spectral analysis.~   "
198153|NCT00969332|"~     The purpose of the study is to investigate if intravenous fish oil, commercially available as~     Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in~     children.~   "
198154|NCT00969319|"~     The aim of this international prospective post-marketing surveillance study is to obtain data~     on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE~     Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.~   "
198155|NCT00969306|"~     Chloroquine might very well be able to increase overall survival in small cell lung cancer by~     sensitizing cells resistant to chemotherapy and radiotherapy.~   "
198156|NCT00969293|"~     The purpose of the study is to evaluate the safety and tolerability of a single~     administration of FOV2302 (ecallantide) in patients with macular edema associated with~     central retinal vein occlusion.~   "
198157|NCT00969280|"~     This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study~     hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture~     in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham~     acupuncture controlled study. Additionally, the investigators will assess the safety of~     acupuncture treatment.~   "
198158|NCT00969267|"~     The aim of the study is to examine whether the ear acupoint stimulation is effective on obese~     women.~   "
198159|NCT00969254|"~     Clinical Study, prospective, comparative, randomized, double-dummy entry with random from a~     total of 80 patients, 40 patients will receive the test medication (Pílulas de Lussen®) plus~     placebo and 40 patients will receive the comparative (Pyridium®) plus placebo.~   "
198160|NCT00969241|"~     This study will examine the relationship between free radicals in the saliva and~     periodontitis. 30 adults, 15 with periodontitis and 15 as a control group will give a sample~     of saliva before treatment and after treatment. The investigators will examine the free~     radicals in both groups.~   "
198161|NCT00969228|"~     The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human~     rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately~     6-12 weeks at the time of first vaccination.~   "
198162|NCT00969215|"~     The purpose of this study is to determine if fractional carbon dioxide laser treatment of a~     burn scar is a more effective method for improving the appearance of scars than the current~     available treatments.~   "
198163|NCT00969202|"~     The purpose of this trial is to evaluate a short course of very focused (stereotactic)~     external beam radiation therapy for the treatment of early stage prostate cancer.~      The investigators will gather scientific information about the tolerance and side effects~     this type of radiation. The investigators will then compare these results with those of~     standard 8 week course of external beam radiation therapy to see if this study treatment is~     equally or more effective in treating prostate cancer.~   "
198193|NCT00968812|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of~     canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes~     mellitus with inadequate control despite treatment with metformin.~   "
198164|NCT00969189|"~     Once a child has been anaesthetised and is fully asleep, a special airway tube called a~     laryngeal mask is often inserted into their mouth to help with their breathing. This tube is~     removed just before the child wakes up.~      A new type of airway tube, called an i-gel airway, has been developed for children, which is~     hoped will be easier to insert, safer once in position, and will be less likely to cause a~     sore throat after the anaesthetic than a standard laryngeal mask. The adult i-gel airway has~     been available for adults since 2007, and early trials have shown very encouraging results.~   "
198165|NCT00969176|"~     The purpose of this study is triple, i.e. document single dose pharmacokinetics and -dynamics~     of intravenous paracetamol in preterm and term neonates after a loading dose (20 mg/kg iv~     bolus paracetamol), document multiple dose pharmacokinetics and -dynamics of intravenous~     paracetamol in preterm and term neonates, based on the daily doses routinely used within the~     neonatal intensive care unit and as reported in literature. Finally, document safety of~     single and repeated dose of intravenous paracetamol in preterm and term neonates.~   "
198166|NCT00969163|"~     Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum~     excretion rates will be measured before and after 6 weeks of treatment.~   "
198167|NCT00969150|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive~     disorder.~   "
198168|NCT00969137|"~     To determine if the mu opioid receptor gene (OPRM1) A118G polymorphism moderates the~     subjective-rewarding effects of intravenous (IV) nicotine in male and female smokers. The~     subjective effects of nicotine will be measured with a Drug Effects Questionnaire, including~     the ratings of good effects and drug liking. We hypothesize that smokers with the AG/GG~     genotype for the OPRM1 A118G will have attenuated subjective-rewarding effects from IV~     nicotine when compared to those with AA genotype.~   "
198169|NCT00969124|"~     The Third Eye Retroscope is a device that can be used with a colonoscope to improve the~     ability of a physician to see areas of the colon that may be hidden from the view of the~     colonoscope.~      Previous studies have shown that physicians are able to detect additional polyps when they~     use the device along with the colonoscope. The purpose of this study is to determine whether~     physicians can detect greater numbers of additional polyps as they gain in experience with~     the device.~   "
198170|NCT00969111|"~     The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or~     conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has~     already returned or the risk of prostate cancer returning.~   "
198171|NCT00969098|"~     Recently, a few small trials have shown promising results on value of~     fluoro-2-deoxy-D-glucose and positron emission tomography imaging in response assessment in~     Malignant Pleural Mesothelioma. These studies considered different parameters in Positron~     Emission Tomography (PET) analysis, mainly the standardized uptake value and volume-based~     parameters such as total glycolytic volume.~   "
198172|NCT00969085|"~     The goal of this clinical research study is to learn if treatment with curcumin can help to~     decrease the size of lesions and/or decrease itching in patients with MF or SS. The safety of~     curcumin will also be studied.~   "
198173|NCT00969072|"~     The primary objective is to assess the safety of GI198745 0.05mg, 0.5mg, 2.5mg once daily for~     52 weeks.~   "
198174|NCT00969059|"~     This study will be a double-blind, placebo-controlled, parallel group study. After enrolment~     and initial assessments, subjects will receive oral GW856553 7.5 milligram (mg) twice daily~     (BID) or matching placebo for 28 days in a 1:1 ratio. Sufficient numbers of subjects will be~     recruited to obtain 142 evaluable subjects. This is a double-blind, randomized,~     placebo-controlled, parallel group study. Subjects will undertake a screening period which~     may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomized~     treatment period of 4 weeks and a follow-up period of approximately 2 weeks. This is a~     multi-centre, double-blind, randomized, placebo-controlled study in subjects who have at~     least moderate intensity of neuropathic pain resulting from peripheral nerve injury due to~     trauma or surgery. It will investigate the efficacy, safety and tolerability of GW856553 over~     28 days of treatment. Approximately 158 subjects will be randomized to ensure 142 evaluable~     subjects. Randomization ratio will be 1:1 for placebo or GW856553 respectively. The dose of~     GW856553 will be 7.5 mg BID.~   "
198175|NCT00969046|"~     This study is exploring different administration schedules (short versus prolonged infusion)~     to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with~     pretreated advanced colon cancer.~   "
198176|NCT00969033|"~     The purpose of this study is to determine the effect of CS-1008 in combination with~     irinotecan compared to irinotecan alone on Progression-Free Survival (PFS) in subjects with~     metastatic or advanced colorectal cancer (CRC) who have failed oxaliplatin-based first-line~     treatment.~   "
198177|NCT00969020|"~     The RRS project is a Randomized Clinical Trial documenting the effect of Remote~     Rehabilitation and Support via a telemedicine solution for patients undergoing an optimized~     fast-track orthopedic surgery procedure with the implementation of a total hip arthroplasty.~     With the telemedicine solution the investigators will support and try to motivate the patient~     to be discharged after only one day of hospitalization.~   "
198178|NCT00969007|"~     The primary objective of the study is to identify baseline and early predictors of favorable~     and unfavorable response to lifestyle intervention. As a secondary objective, the~     investigators would like to validate our questionnaire or other identified predictors as~     clinical tools to guide us in selection of the most suitable candidates for lifestyle~     intervention programs. Assuming the same capacity of our questionnaire to predict an absence~     of weight loss (≥5%) or a loss to follow-up (likelihood ratio for a positive test, LR+ =~     9.9), 70 subjects need to be included in this study in order to find a lower limit of the 95%~     confidence interval above 2.0 for this LR+, which is the limit of an acceptable test. The~     investigators will enroll participants with pre-diabetes and BMI 27-40 in our program and~     administer to them at baseline and at 3 months the designed questionnaire, as well as other~     already well validated questionnaires assessing state of change and readiness to implement~     diet or exercise modifications.~   "
198249|NCT00968071|"~     The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine~     (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or~     high-risk MDS. The safety of this drug combination will also be studied.~   "
198179|NCT00968994|"~     This randomized, controlled trial is designed to evaluate split-thickness donor sites treated~     with exSALT SD7™ compared to donor sites treated with Xeroform®. For the purpose of this~     study, subjects enrolled will have selected donor sites or portions of donor sites designated~     as Test Sites. The selected locations will be randomly assigned treatment with either the~     Test Dressing or the Control Dressing.~      The primary objective of the trial will be to quantify the proportion of the donor sites in~     each group that are healed at 10 and 14 days. Secondary objectives will include: time to~     re-epithelialization, pain with dressing changes and mobilization, ease of use, resource~     utilization and safety, as well as quality of healing and overall cosmetic result. A total of~     25 subjects will be enrolled in the trial.~      The trial duration will be 12 weeks. For the purposes of this trial, healing will be defined~     as ≥ 90% re-epithelialization and must be visually confirmed by the investigator or designate~     and two other people (i.e., research nurse, burn resident, member of the Wound Care Team).~     The maximum time to evaluate healing will be 14 days +/-2 days. A final visit will be~     conducted at 12 weeks for safety and to evaluate the quality of healing.~   "
198180|NCT00968981|"~     This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in~     patients with advanced solid tumors that are refractory to treatment or for whom no standard~     therapy exists.~   "
198181|NCT00968968|"~     This is a randomized, open-label, multi-center Phase III study evaluating the efficacy and~     safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued~     HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible~     subjects will have completed 12 to 24 weeks of first- or second-line treatment with~     trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic~     lesions, or persistence of metastatic disease (stable disease) without unequivocal~     progression or the occurrence of new lesions, and been indicated to continue to receive~     trastuzumab alone as maintenance therapy. Eligible subjects entering the LPT112515 study on~     first-line treatment will have no known history of central nervous system (CNS) metastases;~     subjects entering the study on second-line treatment will have no known history of CNS~     metastases or have stable (asymptomatic and off steroids ≥3 months) CNS metastases. The~     primary objective of this study is to compare progression-free survival (PFS) in subjects~     with HER2-positive MBC randomized to receive treatment with lapatinib plus trastuzumab versus~     those randomized to receive trastuzumab alone. The secondary objectives include overall~     survival, clinical benefit response rate (CR, PR or SD ≥24 weeks) and the qualitative and~     quantitative adverse event profile of the 2 treatment arms. It is estimated that 280 subjects~     (140 per group) will be required to observe 193 PFS events.~   "
198182|NCT00968955|"~     The purpose of the study is to compare the effects of per-operative local infiltration~     analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain~     intensity after total hip arthroplasty.~      The hypothesis is that local infiltration analgesia reduces the acute postoperative pain~     intensity.~   "
198183|NCT00968942|"~     The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of~     RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.~   "
198184|NCT00968929|"~     Recombinant streptokinase (r-SK) is an effective thrombolytic agent developed with gene~     engineering. Its characteristics of high output and low production cost make it affordable in~     treating acute myocardial infarction (AMI) in developing countries. It is unclear whether~     r-SK can be used in patients with pulmonary embolism (PE). The aim of this study was to~     investigate the efficacy and safety of 1.5 million IU r-SK by 2 hours infusion and 20,000~     IU/kg urokinase (UK) by 2 hours infusion in selected PE patients.~   "
198185|NCT00968916|"~     Primary objective: To determine the maximum tolerated dose based on the incidence of dose~     limiting toxicity and the maximum administered dose of AVE8062 administered every 3 weeks in~     patients with advanced solid tumors.~      Secondary objectives:~        -  To assess the overall safety profile of the drug.~        -  To characterize the pharmacokinetic profile of AVE8062 and its active metabolite RPR~          258063.~        -  To evaluate anti-tumor activity of the drug.~   "
198186|NCT00968903|"~     The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg~     iv) versus placebo on postoperative outcome after hip arthroplasty.~      The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to~     fulfill discharge criteria.~   "
198187|NCT00968890|"~     The purpose of the present study is to assess the immunogenicity, safety and reactogenicity~     of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals'~     Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged~     61 years and older.~   "
198188|NCT00968877|"~     Purpose of this study is to investigate the effect of treatment with vitamin D3~     (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients~     with vitamin D deficiency.~   "
198189|NCT00968864|"~     The primary purpose is to determine the ability of CD34+ selection and T cell depletion using~     the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients~     receiving a stem cell transplant from an alternative (unrelated and mismatched related)~     donor. The secondary objectives include evaluation of engraftment, immune recovery, and~     post-transplant infections.~      Patients requiring stem cell transplants for either malignant (cancerous) or non-malignant~     disease will be included in the study. The recipients will be grouped into one of two groups~     based on whether the donor is mismatched related (Cohort A) or unrelated (Cohort B). The~     patient will receive a conditioning regimen including chemotherapy drugs and/or total body~     irradiation based on the disease for which the transplant is performed.~   "
198190|NCT00968851|"~     This study is being conducted to determine the safety and effect on cognitive function of two~     different doses of an investigational medication, EVP-6124, in individuals with schizophrenia~     who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and~     psychotic symptoms will be evaluated.~   "
198191|NCT00968838|"~     The goal of this clinical research study is to compare the effectiveness of a white blood~     cell transfusion with radiated cells to a white blood cell transfusion with cells that have~     not been radiated. The safety of this procedure will also be studied.~   "
198192|NCT00968825|"~     The purpose of this study is to evaluate the efficacy and safety of a single administration~     of RT001 compared to placebo gel for the treatment of moderate to severe lateral canthal~     lines.~   "
198194|NCT00968799|"~     Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the~     cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to~     systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be~     a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by~     the body surface is still highly variable and thus dosing on the body surface is increasingly~     considered controversial for systemic administration.~      For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes~     even less sense, since the aim is the highest possible drug concentration in the peritoneum~     without undue local and systemic toxicity. Furthermore, most studies using intraoperative~     chemotherapy vary the volume of the perfusate according to the size of the patient. Since the~     amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] =~     dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can~     vary considerably between patients. On the other hand pharmacokinetic analyses have shown~     that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy~     even if the amount of the drug remains the same.~      In this study the safety of a new dosing regime will be evaluated. The concentration of~     cisplatin in the perfusate will be held constant independent of body weight or size to~     achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of~     the treatment. All patients should be able to receive full dose systemic carboplatin~     chemotherapy after completion the trial treatment.~   "
198195|NCT00968786|"~     The home monitoring of automated measuring devices may improve the management of the chronic~     diseases, and may decrease the incidence of fatal disease. The investigators conducted a~     small sample and short observation time research to explore the feasibility to carry out~     later large-scale research.~   "
198196|NCT00968773|"~     This is a post-market study of the Rebound Hernia Repair Device to further establish the~     safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population.~     The Rebound Hernia Repair Device will be used for its approved indication in comparison to~     standard hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used~     to detect differences in variables. The study is sufficiently powered to detect a 25%~     difference.~      The study data will include quality of life assessments, visual analogue scale , SF-36,~     Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain)~     and complications/adverse events.~   "
198197|NCT00968760|"~     Sometimes researchers change the DNA (genetic material in cells) of donated T cells (white~     blood cells that support the immune system) using a process called gene transfer. Gene~     transfer involves drawing blood from the patient, and then separating out the T-cells using a~     machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject~     the changed T-cells into the body of the patient.~      The goal of this clinical research study is to learn if an investigational type of gene~     transfer can be given reliably and safely in patients with advanced B-cell lymphoma. B cells~     are a type of white blood cell that fights infection and disease. Lymphoma is a type of~     cancer that affects the immune system, including B cells.~      The gene transfer involves drawing blood, separating out T cells (white blood cells that~     fight infection and disease), changing the T cells' DNA (genetic material) in a specific way,~     and returning the changed T cells back to the body.~      Researchers want to learn the highest dose of the changed T cells that can be given safely.~     Researchers also want to learn how long the changed T cells remain in the participant's body,~     and if the changed T cells can reliably treat B-cell lymphoma. Finally, researchers want to~     learn if interleukin-2 (IL-2) can help the changed T cells last longer in the body.~   "
198198|NCT00968747|"~     The purpose of this study is to examine how acute nutritional challenges affect levels of~     several proteins involved in metabolism. These proteins will be measured in blood and fat~     tissue.~      This study will have several aims.~      One aim is to examine the effect of 72 hours of fasting on fibroblast growth factor-21~     (FGF-21) levels. Participants will spend 3 days and nights in the Clinical Research Center at~     the Beth Israel Deaconess Medical Center in Boston, MA. Daily blood samples will be taken.~     Two fat samples will be taken prior to and at the end of the fast. A subset of participants~     will also have two MRIs, one prior to and one at the end of the fast. We will study healthy~     adults and obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease~     (NAFLD). THIS STUDY ARM IS CURRENTLY NOT RECRUITING~      Another aim is to examine the effect of low-calorie diet on FGF-21 levels. Subjects will~     follow a hypocaloric diet that will be designed to achieve 3-5% weight loss. We will enroll~     participants with liver-biopsy-diagnosed non-alcoholic fatty liver disease. Participants will~     report weekly to the Clinical Research Center at Beth Israel Deaconess Medical Center for~     weight measurements. Blood will be drawn before and after the weight loss. Participants will~     also have an MRI before and after the weight loss.~      THIS ARM IS CURRENTLY NOT RECRUITING~      Another aim of the study is to examine the effect of acute ingestion of glucose, fructose,~     and other sugars on serum FGF21 levels. Subjects in this study will be lean volunteers and~     individuals with metabolic syndrome.~      THIS ARM IS CURRENTLY RECRUITING~   "
198199|NCT00968734|"~     The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3~     (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal~     associated with the administration of the supplement.~   "
198200|NCT00968721|"~     The primary purpose of this study is to pilot test an instrument that the investigators will~     develop to assess decision influences on inflammatory bowel disease patients' medication~     adherence decision-making.~      This pilot study will use an exploratory, descriptive cross-sectional survey approach to~     pilot test the instrument and answer the research questions.~      The main hypothesis is that patients at risk for intentionally modifying their prescribed~     medication regimen will differ on influences on decision-making, health status, and~     utilization of the IBD clinic services compared to those who are intentionally adherent and~     who continue adherence over time.~   "
198201|NCT00968708|"~     The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once~     daily (QD), compared with placebo, in addition to standard of care, in patients with type 2~     diabetes mellitus and acute coronary syndrome.~   "
198202|NCT00968695|"~     Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged~     administration of human albumin in the cardiocirculatory and renal function and hepatic~     hemodynamics in patients with advanced cirrhosis and ascites.~   "
198203|NCT00968682|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer treated with~     trastuzumab may help doctors learn more about biomarkers related to heart dysfunction. It may~     also help doctors predict which patients will develop heart dysfunction.~      PURPOSE: This clinical trial is studying biomarkers to see how well they predict heart~     dysfunction in women with breast cancer treated with trastuzumab.~   "
198204|NCT00968669|"~     To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in~     adult participants with uncontrolled, moderate-to-severe, persistent asthma.~   "
198205|NCT00968656|"~     The main purpose of this study is to see if Positron Emission Tomography (PET) imaging with a~     radioactive tracer called 18F-ISO-1 can accurately identify how quickly cancer cells are~     growing or dividing. A second purpose for this study is to determine, by taking pictures,~     what tissues and organs of the body take up 18F-ISO-1 naturally and to determine how that~     uptake changes over time.~   "
198206|NCT00968643|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known~     which radiation therapy schedule is more effective in treating patients with malignant spinal~     cord compression.~      PURPOSE: This randomized phase III trial is studying two different radiation therapy~     schedules to compare their side effects and how well they work in treating patients with~     malignant spinal cord compression.~   "
198207|NCT00968630|"~     This phase II trial studies the immune response after stem cell transplant in human~     immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer).~     Studying samples of blood from HIV-positive patients with cancer in the laboratory may help~     doctors learn more about changes that occur in the immune system after stem cell transplant.~   "
198208|NCT00968617|"~     This study will define an effective starting dose for subcutaneous administration of MK2578~     to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic~     kidney disease (CKD) who are not on dialysis while evaluating its safety.~   "
198209|NCT00968604|"~     The goal of this clinical research study is to find the highest tolerable dose of BikDD~     nanoparticle that can be given to patients with advanced cancer of the pancreas. The safety~     of this drug will also be studied.~   "
198210|NCT00968591|"~     This clinical pharmacology research study will assess the safety and pharmacokinetics of the~     drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.~   "
198211|NCT00968578|"~     The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg~     iv) versus placebo on postoperative outcome after knee arthroplasty.~      The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and~     improve outcome.~   "
198212|NCT00968565|"~     The purpose of this study is to determine the safety and efficacy of citrate to provide~     anticoagulation of an ECMO circuit without patient anticoagulation. The standard method of~     providing ECMO circuit anticoagulation is the use of heparin which also anticoagulates the~     patient and increases the risk of patient bleeding.~   "
198213|NCT00968552|"~     The investigators' believe that it is important to medical practice to obtain information on~     how expandable metal stents work in a large group of patients who have metal stents placed in~     the gastrointestinal system. The purpose of this research study is to collect information on~     the stent placement in our facility and how the patients responded to the stent placement.~   "
198214|NCT00968539|"~     The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals'~     investigational vaccine GSK2340272A.~   "
198215|NCT00968526|"~     The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals'~     investigational vaccine GSK2340272A.~   "
198216|NCT00968513|"~     This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying~     intensities for smokers hospitalized on acute psychiatric inpatient units.~   "
198217|NCT00968500|"~     The purpose of this study is to understand the experiences and needs of parents who have lost~     a child to cancer. This will aid us in developing an intervention that may help parents cope~     with their loss.~   "
198218|NCT00968487|"~     A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy~     volunteers.~   "
198219|NCT00968461|"~     The goal of this clinical research study is to learn the highest tolerable dose of phenethyl~     isothiocyanate (PEITC) that can be given to patients who have a lymphoproliferative disorder~     that has been treated with fludarabine. The safety of PEITC will also be studied.~   "
198220|NCT00968448|"~     The purpose of this study is to determine weather well trained athletes benefit from~     inspiratory (respiratory) muscle training.~   "
198221|NCT00968435|"~     The purpose of this study is to determine the effectiveness of treatment with bevacizumab +~     cisplatin + cetuximab + IMRT. The doctor wishes to monitor patients for 2 years after the~     completion of study treatment to determine if they are cancer-free during that time. They~     also want to evaluate the side effects that patients experience with this treatment regimen.~   "
198222|NCT00968422|"~     The objectives of this study are to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ABT-384 in elderly subjects.~   "
198223|NCT00968409|"~     The purpose of this study is to see if Positron Emission Tomography (PET) imaging with a~     radioactive form of the hormone progesterone called FFNP will give the same results as~     hormone receptor testing already performed on tissue used to diagnose breast cancer.~   "
198224|NCT00968396|"~     The goal of this clinical research study is to learn if cleaning the stem cells of a patient~     who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product~     capable of replacing the bone marrow after standard treatment with chemotherapy.~   "
198225|NCT00968383|"~     The purpose of this study is to determine whether opening an occluded infarcted artery 3-28~     days after an acute myocardial infarction in high-risk asymptomatic patients with preserved~     infarct zone viability improves left ventricular systolic function and volumes at 6 months~     follow-up. The secondary purpose is to assess the changes in myocardial tissue~     characteristics after late percutaneous coronary intervention (PCI).~   "
198251|NCT00968045|"~     The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding~     and transfusion requirements after coronary artery bypass surgery (CABG) in patients with~     endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a~     prospective, randomized double-blind placebo-controlled single center study.~   "
198226|NCT00968370|"~     The impetus for this study came from the findings of the investigators' recently published~     study entitled Day-care management of severe and very severe pneumonia, without associated~     co-morbidities such as severe malnutrition, in an urban health clinic in Dhaka, Bangladesh.~     If day-care management is found to have comparable efficacy to that of hospital management of~     severe and very severe pneumonia in children then they could be managed at outpatient,~     day-care set ups reducing hospitalization and thus freeing beds for management of other~     children who need hospital care. Such management could also be implemented in rural areas of~     Bangladesh and potentially to other developing countries. Additionally, availability of the~     treatment facility in community set-ups will be cost and time saving for the population. But,~     as patients with severe malnutrition were excluded from the pilot study for ethical reasons,~     the peer reviewers of the manuscript felt that the study findings cannot be applied to the~     treatment of severe and very severe pneumonia in general. Similarly, management of severely~     malnourished children with associated complications relies on hospital-based treatment. In~     another study, a day-care clinic approach by providing antibiotics, micronutrients, diet and~     supportive care to severely malnourished children showed that they could be successfully~     managed at existing day-care clinics using a protocolized approach. Therefore, after the~     successful conduction and publication of these two study results in international journals~     with severe and very severe pneumonia as well as severe malnutrition at the day-care clinic,~     it is mandatory to perform the final study where the investigators will include severe~     malnutrition as well as associated co-morbidities to be applied to the treatment of severe~     and severe pneumonia in children in general to make the treatment approach more widely~     applicable.~   "
198227|NCT00968357|"~     SCV-07 (γ-D-glutamyl-L-tryptophan) is a new immunomodulatory compound that has been developed~     and patented both for composition and immunomodulatory use and is a synthetic dipeptide. The~     efficacy of SCV 07 in treating chronic hepatitis C virus (HCV) infection is expected to arise~     from the drug's ability to stimulate the T-helper 1 (Th1) type immune response and to block~     signal transducers and activator of transcription 3 (STAT3) mediated signaling. The purpose~     of this study is to determine if SCV-07 alone and/or SCV-07 in combination with ribavirin is~     safe and potentially effective for the treatment of genotype 1 compensated chronic hepatitis~     C in subjects who have relapsed after a response to a previous treatment course of at least~     44 weeks with pegylated interferon and ribavirin. All subjects will receive 4 weeks of SCV-07~     (Lead-in Phase), followed by 4 weeks of treatment with SCV-07 in combination with ribavirin~     (Combination Treatment).~   "
198228|NCT00968344|"~     The investigators will test the following hypotheses:~        1. Bedrest will blunt the anabolic response to a mixed nutrient meal, facilitating a loss~          of muscle mass and functional capacity that is only partially restored during~          rehabilitation.~        2. Enriching daily meals with leucine will promote protein synthesis and maintain the~          anabolic response to mixed nutrient meal ingestion. This will preserve lean muscle mass~          and function during bedrest and facilitate the recovery of functional and metabolic~          capacity during rehabilitation.~   "
198229|NCT00968331|"~     Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days~     with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1~     and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles.~      After this induction phase, the CR, PR and SD will continue Lenalidomide with the same~     schedule for other 8 months.~   "
198230|NCT00968318|"~     Tissue expansion has enjoyed a wide range of applications since the technique was popularized~     in the latter quarter of the last century. During the expansion process, subcutaneous fat~     liquefies, skin becomes thinner, muscles atrophy, blood inflow increases, and lymphatics get~     occluded. All these factors predispose to seroma formation and implant extrusion.~      A similar problem occurred with lymphoedema patients, and one of the lines of treatment was~     creation of a connection to the deep lymphatics to facilitate absorption of accumulated~     fluid. The same principle is to be extrapolated to patients having tissue expanders inserted~     in the neck and limbs and its effect is to be noted on the incidence of seroma .~   "
198231|NCT00968305|"~     Asthma is a very common childhood chronic illness and is generally more severe in African~     Americans. The investigators attempted to determine whether a specific immune marker is~     associated with lung function and asthma severity.~   "
198232|NCT00968292|"~     The investigators are currently verifying early data showing that the K3 Promoter prosthetic~     foot affects walking efficiency or stability in transtibial, unilateral amputees when~     compared to their current prostheses. Phase II funds are being used to address these metrics.~     These studies are important basic research, however, while Tensegrity has the unique~     opportunity to study amputee gait and movement in the CGMA's state-of-the-art facility the~     investigators will expand these studies with BRDG-SPAN funding by studying the following~     metrics:~        1. Four Square Step Test (FSST)~        2. Amputee Mobility Predictor (AMP)~        3. Timed Up and Go Test (TUG)~        4. Quality of life (QOL) index (SF-36)~        5. Activity-specific Balance Confidence Questionnaire (ABC)~        6. 3D motion analysis~   "
198233|NCT00968279|"~     The primary objective of this study is to analyze the diagnostic accuracy of coronary CT~     angiography using 320 simultaneous detector results in patients with atrial fibrillation.~   "
198234|NCT00968266|"~     The purpose of this study is to determine if a short motivational patient-centered~     intervention for non-adherent patients is more successful in improving beliefs about~     medication (and adherence) compared to a usual care control group of non-adherent patients.~   "
198235|NCT00968253|"~     The goal of Phase I of this clinical research study is to find the highest tolerable dose of~     RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to~     patients with ALL.~      The goal of Phase II of this study is to learn if the drug combinations can help to control~     ALL. The safety of these drug combinations will be also studied in both phases.~   "
198250|NCT00968058|"~     Children and adults frequently need a 'breathing tube' when having anesthesia for surgery.~     The breathing tube is usually inserted after the anesthesia doctor puts a patient to sleep~     with medicine, so they do not feel the breathing tube. In children, there is often a leak of~     air between the tube and the windpipe, as the tube is not an exact fit. Anesthesia doctors~     usually listen for this leak around the tube by listening to the chest with a stethoscope~     while gently filling the lungs with oxygen from the anesthesia machine. The leak tells them~     if the tube is the correct size, or too small, or too tight. If it is too small, or too~     tight, they usually change the tube for a better fit.~      The purpose of this study is to see what happens to this leak in the 30 minutes after the~     tube is placed. No one really knows if the leak gets bigger, smaller, or stays the same.~     Knowing what happens to the leak will help anesthesia doctors to decide whether to change the~     breathing tube or not. This is important, as a tube that is too tight can lead to breathing~     difficulty after removing the tube at the end of surgery, and a tube that is too small may~     make it difficult for the breathing machine to work effectively for the patient as a result~     of a large leak of air or oxygen.~   "
198236|NCT00968240|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic~     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of~     tumors also exhibits the most aggressive behavior, resulting in median overall survival~     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of~     either surgical resection, external beam radiation or both. All patients experience a~     recurrence after first-line therapy, so improvements in both first-line and salvage therapy~     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently~     used intravenous (IV) therapies even cross the blood brain barrier (BBB). Superselective~     Intraarterial Cerebral Infusion (SIACI) is a technique that can effectively increase the~     concentration of drug delivered to the brain while sparing the body of systemic side effects.~     One currently used drug called, Bevacizumab (Avastin) has been shown to be active in human~     brain tumors but its actual CNS penetration is unknown. This phase I clinical research trial~     will test the hypothesis that Bevacizumab can be safely used by direct intracranial~     superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival~     of patients with relapsed/refractory GBM/AA. By achieving the aims of this study we will~     determine the toxicity profile and maximum tolerated dose (MTD of SIACI Bevacizumab. We~     expect that this project will provide important information regarding the utility of SIACI~     Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to~     our patients in the near future.~   "
198237|NCT00968227|"~     The purpose of this study is to determine if giving blood transfusions to anemic patients~     with subarachnoid hemorrhage will reduce their chances of having a stroke from vasospasm.~   "
198238|NCT00968214|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This research study is looking at tumor and blood samples from postmenopausal women~     with primary breast cancer enrolled on clinical trial CAN-NCIC-MA27.~   "
198239|NCT00968201|"~     A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and~     placebo administered once daily at bed time.~   "
198240|NCT00968188|"~     The purpose of this study is to develop an empirically validated, scientifically-based HIV~     and STI prevention program that can be delivered online to young men who have sex with men~     (YMSM) who were recently tested for HIV.~   "
198241|NCT00968175|"~     The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis~     (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to~     decreasing the severity of abdominal pain when compared to analgesic therapy alone.~   "
198242|NCT00968162|"~     Most bone marrow transplants for children with sickle cell disease are performed using high~     doses of two chemotherapy agents: busulfan and cyclophosphamide for the pre-transplant~     conditioning. This approach produces cure in most cases (approximately 95%). It, however, has~     serious side effects, including seizures and infertility. The primary goal of this study is~     to determine how much we can lower the dosages of busulfan and cyclophosphamide by~     incorporating fludarabine, a safer chemotherapy agent, into conditioning. The secondary goal~     is to develop a better understanding of how bone marrow transplants cause neurologic problems~     like seizures.~   "
198243|NCT00968149|"~     This study will evaluate the effect of montelukast compared to placebo in children during the~     spring allergic rhinitis season.~   "
198244|NCT00968136|"~     This is a randomized, controlled study to compare Short-term ketogenic diet with conventional~     long-term trial in refractory infantile spasms.~   "
198245|NCT00968123|"~     The Purpose of this study is to report a new single portal endoscopic release technique and~     the sequence of the first 50 patients who underwent this release.~      This will be a chart review of the demographics, outcomes, and complications of a sequential~     series of patients undergoing a Seg-Way Endoscopic carpal tunnel release (ECTR).~   "
198246|NCT00968110|"~     This is a pilot feasibility study, using Xolair pretreatment for oral milk desensitization.~     The major assessment will be safety, and the investigators will evaluate for any type of~     reaction, including allergic reactions that occur during the course of the study.~   "
198247|NCT00968097|"~     The main objectives of this proposal are as follows:~      To assess the dynamic uptake and washout of 123-I MNI-340, a potential imaging biomarker for~     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in~     similarly aged Alzheimer's (AD) subjects and healthy controls~      To perform blood metabolite characterization of 123-I MNI-340 in healthy and AD subjects to~     determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-340 as a~     single photon computed tomography (SPECT) brain imaging agent~   "
198248|NCT00968084|"~     Background:~        -  For every CHI research study, patients must fulfill a list of criteria, based primarily~          on their medical condition. To determine whether a patient meets these eligibility~          criteria to participate in a research protocol, researchers must perform a series of~          diagnostic tests and procedures.~        -  These evaluations are designed to evaluate a participant s general medical condition~          (i.e., blood tests, function of certain organs such as the lungs, heart, liver, or~          kidneys), and to confirm a diagnosis or ensure that a healthy volunteer is in good~          condition. They maximize the safety for the patients and healthy volunteers at CHI.~      Objective:~      - To determine the eligibility of patients and healthy volunteers for active CHI research~     protocols.~      Eligibility:~        -  The procedures included in this protocol will determine eligibility for active CHI~          research protocols.~        -  Both healthy volunteers and patients will be evaluated.~      Design:~        -  Required tests and procedures for various research studies may include the following:~          history and physical examination, blood and urine tests, lung and heart function tests~          (echocardiogram, electrocardiogram, stress test), imaging studies (X-rays, magnetic~          resonance imaging (MRI), computerized tomography (CT), and tissue collection.~        -  Participants will be asked to undergo tests only for the study or studies for which they~          are being considered. The research team will provide further information on any~          additional tests that may be required.~        -  After all eligibility assessments are complete, participants may be offered~          participation in one or more CHI research protocols or referred back to a home~          physician.~   "
198252|NCT00968032|"~     The foramen ovale is an opening in the interatrial septum. It results from an incomplete~     coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis~     of the interatrial septum is a clinical finding and is defined as a patent foramen ovale~     (PFO). The Nit-Occlud® PFO umbrella is a permanent implant for closing PFOs that is implanted~     in the PFO using minimally invasive catheter technology. The umbrella is made from Nitinol, a~     material with superelastic properties, which, in its relaxed state, has the form of a double~     umbrella. This is a single-center, non-comparative, prospective interventional clinical~     investigation involving 1 center in Germany to assess the effectiveness, safety and~     practicability of implantation of the Nit-Occlud PFO® Closure Device.~   "
198253|NCT00968019|"~     The purpose of this study is: To evaluate the safety and performance of the Presillion stent~     in routine clinical practice.~   "
198254|NCT00968006|"~     Endothelial progenitor cells (EPCs) are involved in cardiovascular homeostasis, through~     angiogenesis and endothelial healing. Diabetic patients have a high risk of cardiovascular~     events and low levels of circulating EPCs.~      Sitagliptin is an oral DPP-IV antagonist, approved for the treatment of type 2 diabetes. It~     increases the bioavailability of endogenous incretins, thus improving insulin and glucagon~     secretion. SDF-1, one of the major EPC regulators, is also a substrate of DPP-IV. This study~     tests the hypothesis that sitagliptin increases the levels of circulating EPCs in type 2~     diabetic patients.~   "
198255|NCT00967993|"~     The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a~     dietary phosphate binder in controlling and managing serum phosphorus levels in patients with~     end-stage renal disease (ESRD).~   "
198256|NCT00967980|"~     The purpose of this research study is to determine if the insertion site of a perineural~     catheter, or tiny tube placed next to the nerves that go to the hip which you will have~     surgery, affects the amount of pain relief that is experienced after surgery.~   "
198257|NCT00967967|"~     Many patients suffering from allergic rhinitis do not recognize or perceive their symptoms.~     Instruments have been developed to assess quality of life in rhinitis, asthma or both, but~     there is a need to develop validated tools or methods to assess rhinitis control among~     rhinitis and/or asthmatic patients. The aim of this study is to assess the discriminative and~     evaluative properties of the RCSS in asthmatic patients with allergic rhinitis.~   "
198258|NCT00967954|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at blood and tissue samples from patients with~     prostate cancer receiving androgen deprivation therapy.~   "
198259|NCT00967941|"~     This study prospectively selects the patients to examine the effectiveness of the~     investigators' current standard of prophylaxis prior to vascular surgery and to compare the~     effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular~     surgical patients.~   "
198260|NCT00967928|"~     This Phase 1, single-site, dose-escalation study is being conducted to determine the maximum~     tolerated dose (MTD) of RAD001 as part of a specified combination regimen.~   "
198261|NCT00967915|"~     The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant~     breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the~     hypothesis that frenotomy will do all of the above.~   "
198262|NCT00967902|"~     To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting~     Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery~     lesions.~   "
198263|NCT00967889|"~     RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat the cancer.~      PURPOSE: This research study is looking at tissue, blood, and urine samples from patients~     with advanced prostate cancer.~   "
198264|NCT00967876|"~     The investigators aim at analyzing the diagnostic accuracy of 320-row CT for coronary stents.~   "
198265|NCT00967863|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. It is not yet known which dose of~     radiation therapy is more effective in treating patients with prostate cancer.~      PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in~     treating patients with prostate cancer receiving hormone therapy.~   "
198266|NCT00967850|"~     The purpose of this study is to determine the efficacy and safety of intravitreal injections~     of bevacizumab in High Myopia´s choroidal neovascularization versus the standard treatment of~     Photodynamic therapy.~   "
198267|NCT00967837|"~     One of the significant complications associated with some patients with diabetes is the~     inability for wounds to heal regardless of enrolling and participating in a traditional wound~     healing program. There have been a number of anecdotal evidence presented by patients~     receiving pulsatile intravenous insulin therapy for other complications with non healing~     wounds lasting from several months to several years whose wounds healed while receiving~     therapy. This study was designed to specifically monitor the progress of diabetic patients~     who have failed traditional wound care therapy and monitor the progress of their wounds while~     receiving pulsatile intravenous insulin therapy.~   "
198268|NCT00967824|"~     RATIONALE: Evaluating a decision aid that describes the risks and benefits of taking~     tamoxifen citrate to prevent breast cancer may be helpful for women at increased risk of~     breast cancer.~      PURPOSE: This randomized phase I/II trial is studying tamoxifen citrate decision aids for~     women at increased risk of breast cancer.~   "
198269|NCT00967811|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of two~     formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle~     glaucoma.~   "
198292|NCT00967512|"~     The purpose of this study is to assess whether treatment with cenersen in combination with 4~     cycles of high and low-dose chemotherapy (idarubicin and cytarabine) improves the complete~     response rate in acute myelogenous leukemia (AML) patients ≥ 55 years of age who did not show~     a response (CR, CRi, or PR) to a single aggressive frontline induction course.~   "
198270|NCT00967798|"~     Acute systemic hyperglycemia causes oxidative stress and a pro-inflammatory response. The~     pro-inflammatory cytokines induced by hyperglycemia are toxic to islet insulin producing~     cells, and thus worsen glucose intolerance. Patients with cystic fibrosis (CF) have a high~     prevalence of CF related diabetes (CFRD) and up to 40% of CF adults develop CFRD. During the~     prediabetic phase in CF, there is progression from normal glucose homeostasis to high risk~     prediabetes characterized by episodes of acute hyperglycemia after meals and during~     respiratory exacerbations. The mild hyperglycemia seen in CF patients with high risk~     prediabetes following a meal would be expected to induce a degree of systemic inflammation~     and oxidative stress. These repetitive episodes, if left unchecked, could lead to progression~     of glucose impairment, worsening severity of oxidative stress and inflammation, and~     ultimately the development of CFRD, all via hyperglycemia-induced toxicity to beta cells.~     Furthermore, this process may be accelerated in CF because lung disease and resultant~     respiratory exacerbations are associated with oxidative stress and inflammation and this will~     further contribute to beta cell damage.~      Sitagliptin is a recently approved agent for type 2 diabetes and markedly enhances insulin~     secretion in the presence of hyperglycemia and has been shown to be effective in preventing~     postprandial hyperglycemia. The hypothesis to be tested in this project is that sitagliptin~     will prevent the development of CFRD in CF subjects with high risk prediabetes by blocking~     postprandial hyperglycemia. The investigators propose a randomized, double-blind,~     placebo-controlled, multicenter, 15-month longitudinal study in 118 CF subjects with high~     risk prediabetes to test this hypothesis. Specifically, the investigators aim to show that~     chronic treatment with sitagliptin: prevents the conversion to diabetes; results in~     preservation of beta cell function; reduces systemic measures of oxidative stress and~     inflammation; and slows the rate of progression of lung disease.~      Funding Source - FDA Office of Orphan Products Development~   "
198271|NCT00967785|"~     Background:~        -  WHIMS (warts, hypogammaglobulinemia, infection, and myelokathexis syndrome) is caused by~          various genetic changes that increase the activity of the CXCR4 gene. Excessive function~          of this gene causes mature neutrophils (part of white blood cells) to be retained within~          the bone marrow rather than being released to the general blood circulation, and is one~          of the causes of severe inherited neutropenia (low white blood counts). In neutropenia,~          the body is less able to fight off infection. Patients with WHIMS usually are at risk~          for skin, soft tissue, sinus, and lung infections, which can result in loss of hearing,~          teeth, and lung function.~        -  Current treatment for WHIMS consists of regular injections of a white blood cell growth~          stimulating medication called granulocyte colony stimulating factor (G-CSF), and monthly~          infusions of intravenous immunoglobulin (IVIG). These therapies are expensive,~          nonspecific, have significant side effects and toxicities, and do not fully correct all~          problems, especially warts and cancers related to human papillomavirus (HPV).~        -  A drug called Mozobil has been approved for use in combination with G-CSF to increase~          the number of stem cells that can be collected prior to bone marrow transplantation.~          Mozobil may offer a specific and well-tolerated new treatment for WHIMS and other~          syndromes characterized by neutropenia.~      Objectives:~        -  To evaluate whether Mozobil is safe and effective to treat neutropenia (low white blood~          cell count) in patients with WHIMS.~        -  To determine an appropriate treatment dose of Mozobil, within currently approved dosage~          levels.~      Eligibility:~      - Individuals between 18 and 75 years of age who have been diagnosed with WHIMS and have a~     history of severe infections.~      Design:~        -  Potential participants will undergo a screening study, with a medical history, physical~          examination, questionnaire, heart and lung function scans, and blood and urine samples.~          Tests will also be done for hepatitis B and C virus, and human immunodeficiency virus~          (HIV) that causes acquired immunodeficiency syndrome (AIDS), as well as to check~          neutrophil function.~        -  Patients who are being treated with G-CSF will stop injections for 5 days before being~          admitted to the National Institutes of Health (NIH) Clinical Center. While off the~          medication, patients will keep a diary to report information about their general~          well-being while off the medications and will bring it to NIH when admitted.~        -  Patients will be admitted to the NIH Clinical Center inpatient until 2 days before~          starting the treatment and will stay for approximately 10 days. Before the treatment,~          patients will have blood samples taken regularly.~        -  Patients will receive increasing doses of Mozobil over 5 days of treatment until their~          white blood cell count improves sufficiently or the maximum approved dose is reached.~          Blood samples will be taken regularly throughout the treatment process. Patients will~          then receive an additional dose of Mozobil at the maximum approved dose or the dose~          sufficient to cause improvement, before restarting the G-CSF injections.~        -  Between 4 and 6 weeks after the treatment phase, patients will return to the NIH for an~          outpatient study completion and evaluation visit.~   "
198272|NCT00967772|"~     The safety/tolerability and pharmacokinetics (PK) of Naftopidil (commercial name: Flivas)~     after oral administration will be investigated in Korean healthy male volunteers. All~     volunteers will be assigned to 2 groups and administered a lower single dose tablet (Period~     1). After one week's wash-over period, the volunteers take higher dosages (Period 2).~   "
198273|NCT00967759|"~     The primary outcome of this study is to evaluate the clinical efficacy of the dose fixed~     combination and each drug, that composes it, isolated, regarding the respiratory symptoms~     improvement in superior air passages acute affection in children between 2 and 6 years old.~   "
198274|NCT00967746|"~     This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind~     trial of three different doses of etonogestrel releasing medicated intrauterine systems~     (ENG-MIUS) in healthy parous women in need for contraception.~      The primary trial objective is to explore safety and acceptability of three doses of an~     ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.~   "
198275|NCT00967733|"~     The optimal type of oil to prevent cardiovascular disease (CVD) is uncertain. In general,~     unsaturated oils with higher content of cis-monounsaturated fatty acids (MONO) or~     cis-polyunsaturated fatty acids (PUFA) are preferable over those rich in saturated fatty~     acids. However, unsaturated oils can vary in their relative contents of n-6 and n-3 fatty~     acids (specifically alpha-linolenic acid (ALA)). Some investigators advocate that oils rich~     in ALA are cardioprotective, while others suggest that optimal cardioprotective effects can~     only be obtained when oils are lower in n-6 fatty acids (mainly linoleic acid) in addition to~     being higher in ALA. It is hypothesized that increased ALA would result in beneficial effects~     on inflammatory markers. The objective of this trial is to establish definitively the~     biological effects of ALA with and without reductions in linoleic acid on inflammatory~     markers linked to CVD.~   "
198276|NCT00967720|"~     Poor adherence to appropriate asthma medications is an important risk factor contributing to~     high asthma morbidity and mortality in urban African American adolescents. As part of the~     ADEPT (Adolescent Disease Empowerment and Persistency Technology) for Asthma Pilot 2 study, a~     focus group was developed specifically to explore existing barriers to adherence among inner~     city African American adolescent asthmatics.~   "
198277|NCT00967707|"~     The primary objective of this study is to develop a pharmacokinetic (PK) and a~     pharmacokinetic-pharmacodynamic (PK-PD) model for gabapentin in patients with neuropathic~     pain.~      The secondary objectives are to investigate whether adjuvant therapy of venlafaxine or~     donepezil contributes to 1) improved analgesic efficacy and 2) improved health-related~     quality of life (assessed by the SF-36 questionnaire) in neuropathic pain patients treated~     with gabapentin.~   "
198278|NCT00967694|"~     The purpose of this study is to learn if breathing nitrous oxide (also known as laughing~     gas) changes the pressure in a person's eyes. Some patients who need regular eye exams to~     measure their eye pressure often need to be put to sleep with medicine in order to complete~     the eye exam. Some of these medicines are known to cause changes in a person's eye pressure.~     Because of this, such medicines are avoided if the eye doctor needs to measure the patient's~     eye pressure. One medicine that is frequently used to put patients to sleep is nitrous oxide.~     No one really knows what effect nitrous oxide might have on a persons' eye pressure. The~     investigators are interested to see if nitrous oxide causes an increase, decrease, or no~     change in eye pressure. The investigators also want to investigate if there is a difference~     in the effects of nitrous oxide on eye pressure between males and females. Understanding~     these effects of nitrous oxide is important because during such eye exams, the eye doctor~     uses the pressure measurements to make important decisions about treatment and surgery~     options for the patient.~      The investigators hypothesize that the use of inhaled nitrous oxide (N2O) will result in a~     decrease in IOP in healthy volunteers.~      The investigators aim to determine the magnitude and duration of change, if any, in IOP~     caused by inhalation of N2O, and to assess if the gender of the patient has a role in this~     effect.~   "
198279|NCT00967681|"~     The purpose of the study is to evaluate whether Oncoxin, a nutritional supplement, improves~     the clinical and ultrasonographic results in comparison with placebo during 24 weeks of~     treatment.~   "
198280|NCT00967668|"~     ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in~     a study that is examining the impact of an innovative approach to weight loss (Aspiring to~     Lifelong Health in VA, aka ASPIRE-VA). ASPIRE-VA has 3 key features: 1) lifestyle coaches~     who encourage behavior change through a small steps approach; 2) a simplified Stoplight~     diet; and 3) user-friendly enhanced pedometers to help participants monitor their physical~     activity.~   "
198293|NCT00967499|"~     The purpose of this study is to investigate palonosetron versus ondansetron as rescue~     medication in subjects that develop postoperative nausea and vomiting (PONV) in the~     Postanaesthesia Care Unit (PACU).~   "
198294|NCT00967486|"~     The project involves prospectively randomizing patients to either routine carotid shunting or~     selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA)~     to see the difference in post-op complications and occurence rates. Patients will be~     randomized to Routine shunt vs selective groups.~   "
198281|NCT00967655|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Radiation~     therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy, monoclonal antibody~     therapy, and radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying the side effects of giving capecitabine and~     panitumumab together with radiation therapy with or without irinotecan hydrochloride and to~     see how well it works in treating patients undergoing surgery for localized rectal cancer.~   "
198282|NCT00967642|"~     The purpose of this study is to evaluate the effects of intravenous insulin/24 hours to~     normalize glycemia upon markers of oxidative stress (protein oxidation and total antioxidant~     defense) and inflammation (C-reactive protein (CRP) and sCD40L) in diabetic patients~     submitted to PCI with stent.~   "
198283|NCT00967629|"~     The purpose of this study is to determine whether oral sevelamer carbonate binds advanced~     glycation end products (AGEs) in the gastrointestinal (GI) tract of patients with diabetic~     nephropathy leading to decrease body AGE load and therefore decreases the inflammation and~     oxidative stress in these patients.~   "
198284|NCT00967616|"~     This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study~     will be conducted at up to 18 study centers in the US, Central America, and South America.~     Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy~     will participate in the study, which will be conducted on an outpatient basis. It is~     anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.~   "
198285|NCT00967603|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether~     sunitinib malate is effective as maintenance therapy in delaying tumor progression in~     patients with metastatic pancreatic cancer who are progression-free after 6 months of~     induction chemotherapy.~      PURPOSE: This randomized phase II trial is studying sunitinib malate as maintenance therapy~     to see how well it works compared with observation in avoiding tumor progression after~     induction chemotherapy in patients with metastatic pancreatic cancer.~   "
198286|NCT00967590|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety~     and tolerability of RO5036505 in patients with inadequately controlled moderate to severe~     asthma. Patients will be randomized to receive either RO5036505 (380mg iv infusion once~     weekly) or placebo for 8 weeks. Patients will be on a standardized inhaled~     corticosteroid/long-acting beta-agonist regimen during study treatment. Target sample size is~     50-100 individuals.~   "
198287|NCT00967577|"~     The purpose of this study is to evaluate changes in tumor blood flow and disease response to~     the investigation agent, 177Lu-J591.~   "
198288|NCT00967564|"~     The purpose of this study is to evaluate the correlation between quality of life (QoL) and~     hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS~     (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation~   "
198289|NCT00967551|"~     Diarrheal diseases are a major cause of morbidity and mortality globally in children less~     than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in~     developing countries are usually a consequence of micronutrient deficiencies including zinc.~     The primary aims of the proposed study are to evaluate the effect of the use of multiple~     micronutrient sprinkles including zinc on compliance of supplement use and the incidence of~     recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the~     Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da~     Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind~     placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group~     of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into~     2 groups of 60 children each. The intervention group will receive sprinkles containing zinc~     while the control group will receive micronutrient sprinkles without zinc. The primary~     outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both~     groups of infants will be monitored at monthly intervals for an initial duration of 180 days~     for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for~     the establishment of a cohort of children who will be monitored in a micronutrient~     supplementation trial using sprinkles.~   "
198290|NCT00967538|"~     The purpose of this study is to evaluate safety and efficacy of etanercept in patients with~     psoriasis who had an unsatisfactory response to adalimumab and infliximab.~   "
198291|NCT00967525|"~     In this trial the investigators seek to determine if injecting cord blood cells directly into~     the bone marrow (intraosseous injection), rather than infusing them intravenously, can~     improve engraftment. The rational for doing this is that most hematopoietic stem cells (HSCs)~     infused intravenously never reach the bone marrow, getting trapped by other organs, such as~     the lungs, instead. The potential advantage of intraosseous infusion is suggested by studies~     in rodents that have demonstrated that in HSC transplants where the cell dose is limiting~     intraosseous injection is a more effective route of administration. The safety of~     intraosseous injections, in general, is underscored by the vast experience using intraosseous~     injections for resuscitation of critically ill children. The safety of injecting HSCs~     intraosseously has been demonstrated in a clinical trial of transplanting bone marrow cells.~      To safeguard against problems that might result, if intraosseous infusion fails to improve~     engraftment in this trial, the investigators will integrate a recently introduced strategy~     proven to improve engraftment-the transplantation of two cord blood units. Transplanting two~     unrelated cord blood units by intravenous infusion has been shown to improve engraftment~     (although there is still room for improvement). In this trial one unit will be injected~     intraosseously and the other unit will be infused intravenously.~      This study is being conducted as a forerunner to a larger, multi-center trial. The~     investigators intend to enroll five patients over 1-2 years.~   "
198345|NCT00966823|"~     The purpose of this phase 2 limited study is to examine whether prenatal intervention correct~     the lung underdevelopment associated with severe diaphragmatic hernia.~   "
198295|NCT00967473|"~     The purpose of this study is to describe rates of spatial distortions related to intraocular~     lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when~     implanted bilaterally into the capsular bag following phacoemulsification in adult patients~     with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the~     Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in~     the second operative eye.~   "
198296|NCT00967460|"~     The purpose of the study is to evaluate the effect of a project promoting unstructured~     spontaneous physical activity (PA) through an adaptation of the built environment and the~     provision of a supportive social environment of childcare centers on motor skills, physical~     activity, desire to move around, body mass index (BMI), quality of life and PA and behavior~     of the family.~   "
198297|NCT00967447|"~     Open, prospective, uncontrolled, observational cohort study.~   "
198298|NCT00967434|"~     Patients undergoing non-cardiac surgery frequently experience perioperative cardiac~     complications that may be due to excess inflammatory reactions. Lipid lowering drugs called~     HMG-CoA reductase inhibitors or statins, have anti-inflammatory effects. Although favourable~     evidence suggests these drugs could also prevent perioperative cardiac complications,~     definitive evidence of anti-inflammatory effects and benefit is lacking. The purpose of this~     study to measure the impact of a atorvastatin on patients undergoing surgery. It will attempt~     to determine the speed of drug effect as measured by the impact the drug has on the levels of~     the inflammatory mediator called C-reactive protein after surgery. It is hypothesized that~     the perioperative use of atorvastatin will safely reduce the postoperative rise in CRP levels~     at 48 hours after elective vascular surgery. This effect, would then translate into a~     reduction of adverse perioperative complications including reduction in postoperative~     myocardial ischemia episodes (as measured through Holter monitoring).~   "
198299|NCT00967421|"~     The purpose of the validation study is to develop a valid test battery for assessing driving~     ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented~     and well-characterized effects on driving behaviour and accident risk, and will be used to~     assess the simulator test scenarios' sensitivity to drug effects. Once the test scenarios~     have been refined and their ability to predict driving accident risk have been validated, we~     plan to use the simulator to assess driving ability under the influence of different drugs~     suspected to produce driving impairment.~   "
198300|NCT00967408|"~     Rehabilitative treatment in stroke survivors has shown to be effective in improving~     functional outcome and reducing dependency. Plasticity of the central nervous system, along~     with coping strategies and adaptations, seems to play a key role in functional recovery. Some~     data support the hypothesis that drug which improve dopaminergic, serotoninergic and~     noradrenergic transmission in the central nervous system could improve recovery in stroke~     patients. In this population, antidepressants as selective serotonin reuptake inhibitors~     (SSRI) are associated to better outcomes, as evidenced by small clinical trials. However,~     since depression is a common consequence of stroke, observed improvements could be biased by~     the action of these drugs on depressive symptoms, thus improving participation in~     rehabilitative treatment.~      The hypothesis of this study is that SSRI could improve functional outcome in stroke~     survivors not only because of their action on depressive symptoms, but mainly because of a~     direct effect on neural repair and neuronal growth.~      The aim of the study is to evaluate the effect of a SSRI, escitalopram, on functional outcome~     of stroke patients.~   "
198301|NCT00967395|"~     The hypothesis is that healing may influence the patient's general status by altering~     psychological as well as other body functions of importance for the rheumatoid arthritis.~     This is tested in a three group design with a control group and two groups receiving healing~     with or without a healer present. The study is randomized and double blind.~   "
198302|NCT00967382|"~     The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight~     heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and~     venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research~     question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental~     vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE),~     intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?~   "
198303|NCT00967369|"~     The goal of this clinical research study is to learn if bortezomib when given in combination~     with ifosfamide, carboplatin, and etoposide (a routine chemotherapy combination called ICE)~     can help to control Hodgkin's lymphoma better than ICE when given alone. The safety of this~     drug combination will also be studied.~   "
198304|NCT00967356|"~     The aims of this study are to assess the safety, tolerability and pharmacokinetics of single~     ascending oral doses of AZD5985 in healthy male subjects.~   "
198305|NCT00967343|"~     The purpose of this study is to determine whether the administration of a donor lymphocyte~     preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted~     stem cell transplant from a related, haploidentical donor enhances survival by improving the~     immune effect against infections while preventing graft-versus-host disease .~   "
198306|NCT00967330|"~     This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in~     combination with conventional involved field radiotherapy, in patients with newly diagnosed~     glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive~     Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide~     75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po~     daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until~     disease progression, and the target sample size is 100-500 individuals.~   "
198307|NCT00967317|"~     To evaluate the efficacy and tolerability of Auris-Sedina in the symptomatic control of~     otalgy in patients with and without acute external otitis compared with use of Otosynalar®.~   "
198308|NCT00967304|"~     The main objective of this study is to verify whether a new clinical decision rule~     identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence~     can safely stop oral anticoagulant therapy after 5-7 months of treatment.~   "
198513|NCT00964574|"~     Primary Objective:~      To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM)~     patients~      Secondary Objective:~      To evaluate the insulin glulisine doses To assess the patient satisfaction~   "
198309|NCT00967291|"~     RATIONALE: Drugs used in chemotherapy, such as mitomycin C and ifosfamide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving mitomycin C together with ifosfamide~     works in treating patients with metastatic pancreatic cancer.~   "
198310|NCT00967278|"~     The purpose of this study is to study the positioning and stabilization of different cardiac~     walls performed during off-pump coronary artery bypass grafting (CABG) may have dissimilar~     impact on hemodynamics.~      The objective is to evaluate hemodynamics during distal coronary anastomoses in different~     cardiac walls.~   "
198311|NCT00967265|"~     Patient participation is a central concept in Norwegian health policy. It is mandatory in~     hospitals and emphasised as one of the most prioritised areas by the Government. Studies from~     Norway have repeatedly found that patients who seek help in community mental health centres~     (DPS) are dissatisfied with the information they receive and about their possibility for~     real influence in their treatment.~      One way to improve individual patient participation might be to give patients information~     before they start their treatment. This can be done as group based patient education to~     reduce the resources needed. Furthermore, as there are waiting lists for treatment, such~     introduction seminars could be held while patients are waiting to use this time in a~     meaningful way.~      The present study therefore aims at testing the effect of an introduction seminar for~     patients on waiting list in a community mental health centre.~   "
198312|NCT00967252|"~     Despite improvements in perioperative care, non-cardiac surgery remains associated with~     significant and costly complications. Analysis of perioperative deaths in the United Kingdom~     suggests that roughly 80% are directly attributable to infectious and cardiovascular~     complications. The best available evidence suggests that medical optimization is the~     preferred strategy to reduce cardiac risks but there has been no novel strategy to reduce~     nosocomial infection rates in over 20 years.~      Emerging evidence in both the non-operative and operative setting suggest that statin drugs~     may prevent both infectious and cardiac events. The mechanism(s) of action are not entirely~     clear but appear to independent of lipid lowering effects and are often referred to as~     pleiotropic effects. Two key elements of the pleiotropic effects of statins appear to be~     their anti-inflammatory properties and improved endothelial vascular reactivity. The statin~     dose required to maximize these effects is unknown. A large observational trial suggests a~     contradictory dose effect with higher doses associated with reduced infectious complications~     and lower doses associated with fewer cardiac complications. Doctors therefore still have~     many unanswered questions about the use of statins in the perioperative setting. Should they~     be routinely started on all or only certain surgical patients? What dose of statin should be~     used? If a patient is already on a statin, should their dose be altered perioperatively? The~     latter question is particularly relevant in light of the marked increase in statin use.~     Recruitment logs for an ongoing trial demonstrate that over 70% of patients undergoing~     high-risk surgery were taking a statin but at markedly variable doses. This population~     presents an ideal opportunity to determine if there is a dose response relationship between~     statins and pleiotropic effects. We therefore propose an observational study that will~     determine anti-inflammatory and endothelial effects in high-risk surgical patients on varying~     doses of a perioperative statin drug.~      Atorvastatin diminishes the rise in C-reactive protein (CRP), measured 48 hours after~     elective vascular surgery, in a dose dependent fashion.~      Secondary Hypotheses:~      Atorvastatin reduces endothelial dysfunction after elective vascular surgery, as measured by~     brachial artery ultrasound, in a dose dependent fashion.~   "
198313|NCT00967239|"~     RATIONALE: Studying the genes expressed in samples of blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is looking at blood samples from high-risk postmenopausal women~     who received treatment on breast cancer prevention clinical trials NSABP-P-1 or NSABP-P-2.~   "
198314|NCT00967226|"~     Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one~     year of life and do not need treatment. Others require treatment because they cause~     significant symptoms such as pain, or difficulty with breathing, eating or ambulating.~     Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3~     of patients. Unfortunately, steroids have many side effects in babies so physicians have~     sought other ways to treat them. Recently, the use of propranolol, a heart medication, was~     serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side~     effects than steroids but it is not yet known if it works as well as steroids. This study~     seeks to compare the effect and the side effects of propranolol versus steroids for treating~     hemangiomas that cause symptoms in infants.~   "
198315|NCT00967213|"~     The purpose of this study is to evaluate changes in preferential hyperacuity perimeter (PHP)~     and fundus autofluorescence (FAF) in patients with neovascular age-related macular~     degeneration receiving combination of ranibizumab (LucentisTM) and verteporfin (Visudyne®)~     therapy~   "
198316|NCT00967200|"~     RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This research study is looking at tissue samples from patients with glioma or other~     brain tumors.~   "
198317|NCT00967187|"~     To evaluate the antiretroviral activity and safety of 200 mg BID and 300 mg BID doses of~     MPC-4326 administered as monotherapy for 14 days to HIV-1 positive patients. Patients with an~     initial treatment response will have the option to continue MPC-4326 in combination with an~     Optimized Backround Regimen for a maximum of 72 weeks.~   "
198318|NCT00967174|"~     An investigation on the cumulative skin irritation potential of a newly developed 25 mg~     nicotine patch. Evaluation of skin irritation of a newly developed 25 mg nicotine transdermal~     patch~   "
198319|NCT00967161|"~     The purpose of the current study is to analyze and compare the lower-limb joint motions and~     muscle activation patterns during activities of daily living as well as self reported health~     related functional outcomes for patients with osteoarthritis of the knee undergoing one of~     two types of knee replacements: the Evolution Medial Pivot knee (Wright Medical) or the~     Triathlon Posterior Stabilized (PS) knee (Stryker Orthopaedics).~   "
198320|NCT00967148|"~     The blood thinner tinzaparin might increase survival in patients with colon cancer~     undergoing surgical resection. The investigators want to assess if a trial allocating~     patients to prolonged treatment with tinzaparin versus standard of care is feasible.~   "
198347|NCT00966784|"~     The study hypothesis is that 2 Months Daily Supplementation of Orange juice with fibers will~     effect the weight and the plasma lipids.~      This will be a double-blind parallel controlled study. Study population will include 50~     subjects, who will be divided randomly into two groups. The first group will get the Orange~     juice with fibers, and the second group will get Orange juice with out the fibers.~   "
198514|NCT00964561|"~     The purpose of this study is to evaluate the safety and tolerability of short-term dosing of~     IV ciprofloxacin when administered concomitantly with IV Valortim in healthy normal human~     subjects.~   "
198321|NCT00967135|"~     This study is designed to assess:~        1. The impact of taking perioperative pregabalin on the incidence of chronic neuropathic~          pain and postthoracotomy syndrome at 3 months in patients who have undergone a~          thoracotomy with a thoracic epidural as the basic analgesic modality.~        2. The impact of taking perioperative pregabalin on the relief of acute pain, and on the~          use of additional analgesics, such as opioids, for the relief of such pain in patients~          who have undergone thoracic surgery with a thoracic epidural as the basic analgesia.~        3. The impact of taking perioperative pregabalin on the quality of life and level of~          functioning of patients who underwent thoracic surgery 3 months earlier.~        4. The safety profile of pregabalin in this patient population.~      Hypothesis: The basic hypothesis in this study is that a dose of pregabalin administered~     preemptively 1 hour before a thoracotomy, then repeatedly during the postoperative period,~     when neuronal hyperexcitability is at a maximum (i.e., 4 days), will lead to a 33.3% decrease~     in the prevalence of chronic pain 3 months after surgery.~   "
198322|NCT00967122|"~     AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before~     and after a band holiday, in addition to surveying hunger/satiety and behavior changes.~   "
198323|NCT00967109|"~     The purpose of this study is to determine whether a higher threshold for transfusion with red~     blood cells improves the tissue oxygenation.~   "
198324|NCT00967096|"~     Acute graft versus host disease is a frequent and often life threatening complication of~     allogeneic blood and marrow transplantation. The bacteria that normally reside in the~     intestine play a critical role in its development. Injury to the lining of the bowel that~     results from the high dose chemotherapy or radiation that transplant patients receive during~     the week preceding the transplant allows the bacteria to invade the intestines and spread to~     nearby lymph nodes. This, in turn, causes inflammation which has been shown to promote GVHD.~     Both pre-clinical and clinical research has demonstrated that oral antibiotics can prevent~     graft versus host disease by inhibiting these gut bacteria. Rifaximin has several features~     that suggest it could be effective in preventing GVHD. Rifaximin prophylaxis might also~     provide an added benefit by protecting highly immunocompromised transplant patients from~     severe bacterial infections. This pilot trial will allow the investigators to determine the~     feasibility of using Rifaximin for prevention of GVHD and infection in patients undergoing~     allogeneic blood and marrow transplantation. The preliminary results will be used to plan a~     more definitive trial.~   "
198325|NCT00967083|"~     This study is being done to learn what the needs are in relation to the family members. Some~     family members seek counseling; others do not. The institution wants to try to understand why~     and wants to see if they can improve our support services for family members.~   "
198326|NCT00967070|"~     An investigation on the skin sensitization potential of a new nicotine patch. Evaluation of~     the potential of a new nicotine transdermal patch to cause sensitization in the skin after~     repeated applications.~   "
198327|NCT00967057|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. It is not yet known~     which combination chemotherapy regimen is more effective in treating young patients with~     acute lymphoblastic leukemia.~      PURPOSE: This partially randomized phase III trial is studying how well combination~     chemotherapy works in treating young patients with relapsed or refractory acute lymphoblastic~     leukemia.~   "
198328|NCT00967044|"~     Objectives:~      Primary:~        -  Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the novel~          combination of everolimus + Panobinostat (LBH589) in a phase-I study in patients with~          relapsed lymphoma (Hodgkin and non-Hodgkin).~        -  Determine the safety and efficacy of this novel combination in a phase-II study in~          patients with relapsed Hodgkin and non-Hodgkin lymphoma~      Secondary:~        -  Determine the in vivo effect of therapy on selected serum cytokines/chemokines~          (TGF-beta, thymus and activation-regulated chemokine (TARC), IL-6, IL-10, VEGF).~        -  Examine pre-treatment level of selected molecular targets (HDACs 1-11, STAT6, pSTAT6,~          STAT3, pSTAT3, Myc, Akt, Pichia anomala killer toxin (pAkt), S6, pS6, p21, cyclin D1) in~          primary lymphoma cells and the surrounding reactive inflammatory cells obtained by core~          needle biopsies from patients with relapsed lymphoma.~        -  Examine the correlation between molecular and biologic markers and clinical response~          and/or treatment-related toxicity.~   "
198329|NCT00967031|"~     RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate~     together with capecitabine may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with~     capecitabine works in treating patients with stage IV breast cancer and brain metastases.~   "
198330|NCT00967018|"~     Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30~     (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of~     degarelix until the drug is launched in their country. Safety parameters such as~     electrocardiogram (ECG), blood and urine samples and general health state will be studied.~     Note: patients completing the CS27 trial did not participate in the CS34 trial.~   "
198331|NCT00967005|"~     The objective of this application is to examine whether, given its mechanism of action, the~     dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and pathological~     gamblers (PG) symptoms in nicotine dependent pathological gamblers.~   "
198346|NCT00966810|"~     Allogeneic stem cell transplantation, the only known curative modality for CML, was abandoned~     in recent years for a very effective and much less toxic targeted therapy with the tyrosine~     kinase inhibitors (TKIs). However, approximately one third of patients still need another~     treatment including stem cell transplantation. The study protocol comprised a cohort of~     consecutive patients with CML who received allogeneic stem cell transplantation using partial~     T cell depletion, with no post-transplant GvHD prophylaxis. Forty consecutive patients with~     CML underwent allogeneic stem cell transplantation from a matched sibling using partial T~     cell depletion (TCD), in a single institution. Escalated dose of donor lymphocyte infusion~     (DLI) was given in case of either relapse or presence of minimal residual disease (MRD) as~     detected by cytogenetic or molecular analysis.~      The purpose of the study is to decrease transplant-related toxicity.~   "
198332|NCT00966992|"~     The treatment of cervical cancer with chemotherapy and radiation will make women post~     menopausal (no estrogen from the ovaries), if a woman is not already in menopause. Estrogen~     plays a key role in maintaining bone health. Therefore, these women are at higher risk of~     getting osteoporosis (decrease minerals in the bone) and bone fractures. The overall purpose~     of this research is to look at the effects of zoledronic acid (Zometa) on preventing bone~     loss. Studies have also shown that zoledronic acid may prevent metastasis to the bone which~     can occur in women with cervical cancer. Zometa is investigational (not approved by the Food~     and Drug Administration (FDA)) in this study to prevent metastasis to the bone in women with~     cervical cancer. Therefore, the goal of this study is to also look at the effects of~     zoledronic acid (Zometa) on circulating tumor cells in the bone marrow and blood. This study~     is being done to find a way to prevent bone loss and metastasis to the bone in women~     undergoing chemotherapy and radiation for cervical cancer. An additional component of the~     study is to assess the importance of stress on immune markers in blood during standard~     treatment.~   "
198333|NCT00966979|"~     The purpose of the study is to evaluate the Triathlon® PKR Knee System and determine whether~     or not the success rate of this device is no worse than the reported success rate of similar~     devices.~   "
198334|NCT00966966|"~     The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the~     plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to~     assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.~   "
198335|NCT00966953|"~     Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a~     4-day brushing regiment~   "
198336|NCT00966940|"~     The purpose of this study is to assess the safety and efficacy of Travoprost 0.004% and~     Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when~     both medications are administered in the evening.~   "
198337|NCT00966927|"~     The purpose of this study is to investigate the level of functional independence and the~     quality of life of adolescents and young adults with spina bifid in an Italian population.~   "
198338|NCT00966914|"~     Tavocept is an investigational drug that is being developed to see if it can increase the~     survival of patients who are being treated with chemotherapy as well as to see if it can~     prevent or reduce side effects of chemotherapy. This research study is aimed at trying to~     find out if people with advanced adenocarcinoma of the lung who are treated with a standard~     combination of chemotherapy drugs will live longer if they are also treated with an~     investigational drug called Tavocept. Another objective of this research study is to find~     out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage,~     anemia, and nausea and vomiting that can occur with these drug combinations. The drug~     combinations that will be used in this research study will include either paclitaxel and~     cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to~     treat people with advanced NSCLC. Every patient on this research study will be treated with~     standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these~     will be recommended by your research study doctor), which will be given in combination with~     cisplatin.~   "
198339|NCT00966901|"~     An evaluation of the effects of UV exposure following the use of a new nicotine patch.~   "
198340|NCT00966888|"~     RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill~     tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain~     after surgery. It is not yet known whether radiation therapy is more effective than~     observation after mastectomy in treating women with stage II breast cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared with standard therapy in treating women with stage II breast cancer who have~     undergone mastectomy.~   "
198341|NCT00966875|"~     The primary purpose of the study is to help answer the following research questions, and not~     to provide treatment for Rheumatoid Arthritis (RA):~        -  The safety of LY2439821 and any side effects that might be associated with it.~        -  Whether LY2439821 can help participants with active RA.~        -  How much LY2439821 should be given to participants.~   "
198342|NCT00966862|"~     The aim of this study is to investigate the glycemic effect of supplementation Fibers in~     orange juice.~      This will be a double-blind parallel controlled study. Each subject will serve as his own~     control.~      Study population will include 10 subjects. The subjects will be randomly assigned to receive~     one of two juices in occasion, in two visits. Each drink will be containing orange juice~     with\without fibers.~   "
198343|NCT00966849|"~     The purpose of this study is to determine whether cash transfers (conditional and~     unconditional) can improve health and social outcomes amongst children living in vulnerable~     households in Manicaland, eastern Zimbabwe. The study hypotheses are:~        1. Cash transfers will increase the percentage of vulnerable children aged 0-4 years with a~          birth certificate.~        2. Cash transfers will increase the percentage of vulnerable children aged 0-4 years with~          up-to-date vaccinations.~        3. Cash transfers will increase the percentage of vulnerable children aged 6-12 years~          attending primary school at least 80% of days per month.~   "
198344|NCT00966836|"~     Cardiac allograft vasculopathy (CAV) is the major cause of long-term graft failure in heart~     transplant recipients. Although several immune-mediated and metabolic risk factors have been~     implicated in the pathogenesis of CAV, no effective therapy is currently available to treat~     established CAV and prevent its adverse outcomes. Therefore, the main clinical strategy is~     based on prevention and treatment of factors known to trigger its development. Although the~     mechanism is vague, cytomegalovirus (CMV) infection is believed to play a key role in CAV~     progression.~      Two strategies involving administration of specific anti-CMV agents are recommended for~     prevention of CMV infection/disease: universal prophylaxis and preemptive therapy. The pros~     and cons of the two strategies are still debated, in the absence of randomized studies~     addressing graft-related outcomes and viral mechanisms of graft damage, and without any clear~     evidence of superiority of either approach.~      The investigators conceived this randomized prospective project to compare the effect of~     preemptive anti-CMV strategy with universal anti-CMV prophylaxis on CMV infection and on~     one-year increase in coronary intimal thickening. Patients will be additionally randomized to~     receive either mycophenolate mofetil or everolimus, in light of the possible anti-CMV~     properties of everolimus.~   "
198348|NCT00966771|"~     The purpose of this study is to see if women presenting for emergency contraception (EC) and~     choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next~     year compared to women who choose oral levonorgestrel for EC. The study will also compare use~     of an effective method of contraception in the year after they received EC.~   "
198349|NCT00966758|"~     In this open prospective study, 6 well controlled asthmatic patients will undergo a~     high-resolution multi-slice computed tomography (CT) scan, lung function tests and a SPECT~     scan to obtain patient specific geometries of the central and peripheral small airways,~     patient specific boundary conditions and the in-vivo spatial distribution of inhaled~     aerosols.~   "
198350|NCT00966745|"~     Maintaining a low central venous pressure during living donor hepatectomy is routine~     practice. The investigators tried to test the hypothesis that using milrinone to maintain a~     low central venous pressure (CVP) during is associated with a superior surgical field and~     less blood loss.~   "
198351|NCT00966732|"~     Fibromyalgia is a common, costly and debilitating illness which affects mostly women.~     Fibromyalgia patients report widespread musculoskeletal pain, fatigue, stiffness, and~     distress. Several consensus statements indicate that optimal care combines medication,~     exercise, and psychology. Yoga is a popular mind/body discipline which holds promise for~     reducing fibromyalgia symptoms. The aim of this pilot study is to evaluate the effects of an~     innovative program, Yoga of Awareness, in which yoga poses are complemented by meditation and~     breathing exercises, presentations on healthy coping, and group discussions. Fifty-six women~     with fibromyalgia will be recruited and randomly divided into two groups. One group will~     receive the yoga program right away, and the other group will wait 3 months before receiving~     the program. Information about fibromyalgia symptoms and functioning will be collected from~     both groups before and immediately after the first group receives the yoga program. When~     results from the 2 groups are compared, the investigators expect patients who received the~     yoga program will have greater gains in fibromyalgia symptoms, physical function and pain~     coping capacities then those waiting to receive the program. If this study shows the yoga~     program is effective, the investigators will use this data in 2010 to apply to the National~     Institutes of Health for a more complete study of its benefits.~   "
198352|NCT00966719|"~     Breastfeeding decreases the risk of many infantile infectious diseases and certain types of~     cancers in women. It strengthens the bond between mothers and babies and decreases the health~     care cost to society by making children healthier. Although it is controversial,~     breastfeeding has been reported to increase the risk of jaundice in the neonatal period.~     There is some evidence that mothers of hospitalized jaundiced infants discontinue~     breastfeeding early, as they feel responsible for the baby's condition.~      The main objective of this study is to determine the effect of a breastfeeding intervention~     on breastfeeding duration in jaundiced infants. All eligible infants will be randomized to~     one of two groups (an intervention or a control group). Mothers of infants in the~     intervention group will meet with a lactation consultant during their hospital stay, and~     three times post hospital discharge. Lactation consultants are individuals who have received~     certification in breastfeeding support from an international board, ensuring safe and~     effective practice. Mothers of infants in the control group will receive the current standard~     of care, which is typically support from the nursing staff, who are often not trained in~     lactation support. Information will be collected on length of time that infants are fed only~     breast milk, future visits to health care providers, mothers' need for breastfeeding support~     post hospital discharge, mothers' perception of their physicians' attitudes towards~     breastfeeding, and mothers' experiences at the hospital, as well as feedback on the~     intervention. Phone follow-up will occur one week post hospital discharge, and when the child~     is 2, 3, 4 and 6 months old.~      The results of this study will clarify the importance of offering sound breastfeeding advice~     to mothers of young infants hospitalized with jaundice and help determine whether there is a~     need for trained lactation specialists in children's hospitals. It will allow us to examine~     whether such an intervention can have a quantifiable impact on children's health in their~     first 6 months of life, as measured by physician encounters and hospitalizations. It will~     also allow collection of information on advice and support given to breastfeeding women by~     primary care physicians, potentially identifying needs for more rigorous breastfeeding~     training during medical training.~   "
198353|NCT00966706|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine~     hydrochloride, epirubicin hydrochloride, and docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known~     whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given~     together with epirubicin hydrochloride or docetaxel in treating patients with advanced or~     metastatic pancreatic cancer.~      PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin,~     capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared~     with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel~     and to see how well it works in treating patients with stage III or stage IV pancreatic~     cancer.~   "
198354|NCT00966693|"~     The goal of the Phase I portion of this clinical research study is to find the highest~     tolerated dose of the combination of thalidomide, lenalidomide, and dexamethasone that can be~     given to patients with relapsed or refractory MM.~      The goal of the Phase II portion of this study is to learn if the drug combination can help~     to control the disease.~      The safety of the drug combination will be studied in both phases.~   "
198355|NCT00966680|"~     The researchers wish to undertake a simulation based study to compare the speed of general~     versus spinal anesthesia for emergency cesarean delivery. Minutes may matter for the baby in~     an emergency. It is unknown which technique is quicker. Their hypothesis is that surgical~     anesthesia can be achieved as quickly with spinal as with general anesthesia.~   "
198356|NCT00966667|"~     RATIONALE: Gathering information over time from patients who have finished treatment for~     colorectal cancer may help doctors predict which cancer survivors will improve their physical~     activity and diet.~      PURPOSE: This clinical trial is studying health behaviors in patients who have finished~     treatment for stage I, stage II, or stage III colorectal cancer.~   "
198357|NCT00966654|"~     This research is being done to see if giving a hormone called GLP-1 can improve heart~     function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in~     people who have non-emergent coronary artery bypass graft (CABG) surgery.~   "
198358|NCT00966641|"~     The purpose of this study is to determine the single-dose pharmacokinetics of the~     investigational drug PL 3100 following oral administration to healthy volunteers and to~     compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.~   "
198370|NCT00966485|"~     The investigators prospectively studied the effect of aspirin on platelet function in 106~     stable outpatients 6 months after successful percutaneous coronary angioplasty. Participants~     were randomized in a double-blind, double-crossover study (80 or 500 mg per day for 6~     months).T~   "
198371|NCT00966472|"~     The purpose of this study is to determine the recommended phase II dose (RP2D) of~     rosuvastatin that can be given in combination with standard erlotinib treatment in patients~     with advanced incurable squamous cell cancer and NSCLC.~   "
198359|NCT00966628|"~     Dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) are among the leading causes~     of pediatric hospitalization in Asia.Mortality rates range from 1% at centres experienced in~     fluid resuscitation, to upto 44% in established shock.The mainstay of DSS treatment is~     prompt, vigorous fluid resuscitation with isotonic crystalloid solutions, followed by plasma~     or colloid solutions for profound or continuing shock. However, this administration is often~     associated with fluid overload and induces edema in these patients.~      Hence, we planned a parallel, randomized controlled trial comparing the efficacy and safety~     of solution containing half molar sodium lactate (Totilac™) with standard treatment(isotonic~     crystalloid Ringer's Lactate) in pediatric Dengue Shock Syndrome patients, using plasma~     soluble Vascular Cell Adhesion Molecule(sVCAM-1) levels as an indicator.~      Hypertonic solutions restore hemodynamic status rapidly with increased cardiac performance~     and improved tissue perfusion. This is obtained with much smaller volumes.We plan to assess~     the efficacy and safety of hypertonic sodium lactate in resuscitation of DHF/DSS patients.~   "
198360|NCT00966615|"~     Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated~     as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD~     patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a~     superior profile of PD effluent mesothelial cell marker and a lower degree of systemic~     inflammation as compared to conventional PD solution. The investigators propose a prospective~     randomized control study to compare the arterial stiffness, nutrition and body fluid status~     between PD patients treated with conventional solution and those with neutral pH low GDP~     solution. The investigators plan to study 100 new PD patients. They will be randomized to be~     treated with neutral pH low GDP solution or conventional solution. All patients will be~     followed for 52 weeks. In addition to routine clinical measurements, the investigators will~     measure their body water composition by bioimpedance spectroscopic method, arterial pulse~     wave velocity by pressure transduction method, as well as radiographic parameters of~     intravascular volume status, based on the routine chest radiograph. The study would help to~     define the clinical benefit of biocompatible PD solution.~   "
198361|NCT00966602|"~     The purpose of this study is to assess the pharmacokinetics and safety of co-administration~     of VX-770 and VX-809 in healthy adults.~   "
198362|NCT00966589|"~     Five to ten percent of athletes and physical active adults are suffering chronic groin pain.~     The most common diagnoses are adductor tendinitis, sportsman hernia and osteitis pubis.~     Sportsman hernia is not a real hernia in the groin, but overuse injury of the groin muscles~     and tendons. No evidence-based treatment of this disabling condition has been found so far.~     Experimental surgical treatments are based on various hernioplasties. Laparoscopic~     extraperitoneal hernioplasty (TEP) is a mini-invasive and effective method to heal sportsman~     hernia in non-randomized cohorts.~   "
198363|NCT00966576|"~     The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma~     patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin~     monotherapy.~   "
198364|NCT00966563|"~     The present feasibility study is designed to find out whether pre-treatment with the compound~     mangafodipir (PP-099) provides an additional reduction in myocardial infarct size in patients~     treated with primary percutaneous coronary intervention (PCI) during acute myocardial~     infarction (AMI).~   "
198365|NCT00966550|"~     The purpose of this research study is to test whether certain compounds in tomatoes will help~     reduce factors in the subject's blood associated with disease risk. The investigators want to~     know if the tomato-associated compounds will lower or improve the status of these factors,~     like cholesterol and inflammation. In this research study, the subject will be asked to~     consume high fat test meals on two separate occasions. The investigators want to see how the~     subject's body responds to a standard high fat meal, one meal with tomato products and one~     meal without tomato products. The investigators will measure the subject's blood throughout~     the study period to determine if consumption of tomato products reduces factors in their~     blood associated with disease risk.~   "
198366|NCT00966537|"~     The aim of this study is 1) to study the clinical application of 3D/4D ultrasound for fetal~     scanning during pregnancy; 2) ) to study the clinical application of 3D/4D ultrasound for~     pelvic scanning; 3) to demonstrate how to optimally display the different organs. 4) to~     correlate our findings with other diagnostic tools like MRI, CT; 5) to correlate our findings~     with clinical outcome.~   "
198367|NCT00966524|"~     Purpose: This study is designed to assess the impact of teaching tracheal intubation using~     video-guided feedback on the ability to perform and maintain this clinical skill by medical~     students.~      Hypothesis: We hypothesise that, for novices, video-guided feedback provided during tracheal~     intubation will improve learning and retention of this clinical skill compared to standard~     teaching using direct visualization feedback.~   "
198368|NCT00966511|"~     The primary purpose of the study is to investigate the use of VRI to guide the selection of~     patients for lung surgery. Perfusion scintigraphy is the current method to assess the~     fractional contribution of lung function of the remaining lung.~      The hypothesis is that VRI can determine quantitative postoperative lung function equally~     accurately as a quantitative perfusion scan.~   "
198369|NCT00966498|"~     Before the transplant, the patient will have a pre-transplant evaluation. This will help find~     out whether there are health problems that will prevent the transplant. It also provides~     baseline tests that will be used later to see whether or not organs have gotten better or~     worse after the transplant. Prior to the stem cell collection, the patient will get~     chemotherapy to help try to put him/her in remission and to push more stem cells into the~     peripheral blood (mobilization). The study doctor will decide which chemotherapy will be used~     for this part of the study. Once mobilization is completed, the peripheral blood stem cell~     collection (apheresis) will be done in the clinic. The apheresis machine will draw blood out~     of the central line. The blood then passes through the apheresis machine and the stem cells~     are separated out. The remaining blood is sent back through the central line. If the~     investigators are unable to collect enough peripheral blood stem cells, a bone marrow harvest~     may be necessary to collect more stem cells.~      The patient will then be admitted to the hospital for the first transplant. He/she will get~     Thiotepa and Cyclophosphamide. Then the patient will be given back the cells that were~     collected. The cells are given in the same manner as a blood transfusion. The patient will be~     kept in the hospital until he/she is stable and blood counts are increasing. Approximately 6~     to 8 weeks after Day 0 of the 1st transplant, the patient will be admitted for the second~     transplant. At this time, he/she will get Busulfan and Melphalan and then the collected cells~     will be given back. The patient will be kept in the hospital until he/she is stable and blood~     counts are increasing. Frequent clinic follow-up is required.~      This study is open to patients who are less then 21 years of age with refractory or relapsed~     high-risk, solid tumors, excluding neuroblastoma (there is a cooperative group trial for~     these patients). Patients will be identified by the Transplant team and eligibility will be~     verified by a member of the clinical research team. Patients will be cared for by members of~     the Transplant team and various other subspecialty physicians.~   "
198372|NCT00966459|"~     In this study, 20 COPD patients will undergo a high-resolution/multi slice CT scan and lung~     function tests to obtain patient specific geometries of the central and peripheral small~     airways and patient specific boundary conditions.~      With Computational Fluid Dynamics (CFD), the investigators will be able to reconstruct the~     geometry and measure the resistance of the peripheral airways.~      In a later stage, CFD will be used to simulate the reaction of the airways on various~     inhalation medications.~   "
198373|NCT00966446|"~     The overall goal of this project is to elucidate the epidemiology of MRSA transmission in the~     community and test an intervention to prevent MRSA transmission in this setting.~   "
198374|NCT00966433|"~     The purpose of this research study is to compare difference between breathing by oneself or~     with the partial help from an anesthesia machine in children under general anesthesia.~   "
198375|NCT00966420|"~     The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the~     large (and small) intestine can be facilitated by using a traction on the lesions.~   "
198376|NCT00966407|"~     The AIMM Young study is a collaboration between Children's National Medical Center (CNMC) and~     colleges/universities nationwide--currently including Howard University (HU), East Carolina~     University (ECU), and University of Massachusetts, Amherst (U Mass). This study obtains a~     variety of baseline measures (such as serum biomarkers related to metabolic syndrome,~     anthropometrics, muscle strength, and fitness testing) along with genetic information from~     healthy college-age (18-35 years) young adults in efforts to identify phenotype-genotype~     associations that may predispose individuals to developing metabolic syndrome, type 2~     diabetes, and/or related diseases such as obesity.~      We hypothesized that certain genetic variations will be protective against metabolic~     syndrome, while others will show a strong correlation with specific components of metabolic~     syndrome disease. We expect that the study of pre-symptomatic, young individuals will~     facilitate the identification of genetic risk loci for metabolic syndrome and type 2~     diabetes. Younger populations typically have less confounding variables, and this facilitates~     normalizing of metabolic syndrome features and environment/lifestyle. Additionally, young~     subjects can provide more robust longitudinal data, and be recruited into subsequent~     interventions to reverse the trend towards metabolic syndrome, rather than the more difficult~     task of reversing type 2 diabetes in older populations. The data collected will be stratified~     according to gender, age, ethnicity, genotype, and other phenotypic measures to determine how~     these factors influence disease risk.~   "
198377|NCT00966394|"~     Attention deficit and hyperactivity (ADHD) affect 6% of school-aged children. Few studies~     reported higher prevalence of caries and restorations among children with ADHD.~     Methylphenidate is the drug of choice to treat ADHD. according to the medical literature~     methylphenidate can cause xerostomia.~      Our study will investigate saliva parameters (such as quantity, bacteria in saliva, buffer~     capacity), oral hygiene and diet habits and their influence on caries among children with~     ADHD and among healthy children.~      Our hypothesis is:~        -  Children with ADHD will have more caries.~        -  Children with ADHD will have more detrimental oral hygiene and diet habits.~        -  There will be a difference in the saliva parameters between children with ADHD and~          healthy children.~   "
198378|NCT00966381|"~     Approximately 8 million American women suffer from osteoporosis, and one out of every two~     women over the age of 50 will have an osteoporotic-related fracture in their lifetime (42).~     While epidemiological studies suggest that pregnancy and lactation are not associated with~     risk of fractures later in life, these studies did not control for site-specific decrements~     in bone mineral density (BMD). In addition, 55% of American women between the ages of 20 to~     39 are overweight (14). Excess weight retention after pregnancy increases a woman's risk for~     developing a chronic disease later in life (44). There is a paucity of research on exercise~     and dietary interventions in postpartum lactating women aimed at promotion of bone health and~     weight loss.~      The goal of this study is to promote long-term lifestyle changes through a home based~     strength training, aerobic, and nutrition intervention targeting overweight lactating women.~     The objective is to attenuate lactation-induced bone loss and promote weight loss. We~     hypothesize that the intervention group will lose a greater amount of fat mass while~     preserving lean mass and bone mineral mass and increase levels of anabolic hormones through~     diet and exercise compared to the minimal care group. Additionally, the acquisition of such~     knowledge is unique since no other studies have measured growth hormone and insulin-like~     growth factor-1 in lactating women with respect to bone and exercise. This intervention will~     encourage breastfeeding, weight loss and an increase in bone density resulting in healthy~     infants and mothers.~      The proposed research is the first to examine the effects of a resistance exercise and weight~     loss intervention on attenuation of lactation-induced bone loss in overweight women. To our~     knowledge, this is the first study to use MyPyramid for Menu Planner for Moms for dietary~     counseling using the total diet approach. The expected outcomes are the intervention group~     will lose weight while preserving lean body mass, bone mineral mass and increase~     cardiovascular fitness and strength compared to the minimal care group. Additionally, the~     exercise group will improve the overall quality of their diet using internet based~     technology. An increase in activity and promotion of weight loss through a modest reduction~     in calories may lead to overall improvement of the mother's bone and health status later in~     life.~   "
198379|NCT00966368|"~     This trial was conducted in North America. The aim of this clinical trial was to investigate~     if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the~     body.~   "
198380|NCT00966355|"~     This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide~     in patients with variceal bleeding for the control of variceal bleeding in combination with~     endoscopic therapy.~   "
198381|NCT00966342|"~     This is an invitation to consider taking part in a research study occurring just before the~     upcoming influenza vaccination program across Canada. The purpose of the study is to closely~     assess influenza vaccine safety and immune responses, as part of a nationwide, annual~     surveillance project sponsored by the Public Health Agency of Canada. Such scrutiny is~     important given the changing nature of flu vaccines from year to year.~   "
198382|NCT00966329|"~     Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the~     following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the~     NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.~   "
198383|NCT00966316|"~     The purpose of this study is to determine whether the clinical pathway for acute ischemic~     stroke(with combination of traditional Chinese medicine and western medicine) is able to~     improve the outcome of acute ischemic stroke and evaluate its effect on hospital day and~     cost, etc. Meanwhile, the study will discuss the safety and efficiency of this kind of~     Clinical Pathway~   "
198384|NCT00966303|"~     This quantitative study aimed to evaluate the respiratory muscle strength, pulmonary~     function, cardiovascular function, and impact on quality of life in patients after cardiac~     rehabilitation associated with the diaphragmatic muscle training.~   "
198401|NCT00966082|"~     This study is performed to compare the efficacy and safety of EBL alone and EBL combined with~     propranolol in patients who were previously performed endoscopic variceal treatment.~   "
198385|NCT00966290|"~     Background: Whether the management of vitamin K antagonists (VKA) therapy by general~     practitioners with the collaboration of anticoagulation clinics (ACC) provides better~     clinical outcomes than that accomplished by general practitioners alone (usual care [UC]~     management) is not clear.~      Objectives: To compare ACC-based shared-care management with UC management of VKA therapy~     with respect to clinical events.~      Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at~     least three months. The primary study outcome is a composite of confirmed symptomatic~     thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All~     outcomes are reviewed by a central, independent adjudication committee.~   "
198386|NCT00966277|"~     The goal of this clinical research study is to learn if dalteparin can lower the risk of VTE~     occurring in the legs and lungs. This will be tested in patients with pancreatic cancer who~     are going to receive chemotherapy. Some patients will receive dalteparin and some will~     receive no study drug.~      The safety of dalteparin will also be studied.~   "
198387|NCT00966264|"~     A randomised study including 236 women referred for essential menorrhagia to five university~     hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life~     issues in the treatment of menorrhagia.Participants were randomly assigned to treatment with~     LNG-IUS (n=119), or hysterectomy (n=117), and were monitored for ten years. The primary~     outcome measures were health related quality of life (HRQoL), other measures of psychosocial~     well-being (anxiety, depression, sexual functioning), and costs.~   "
198388|NCT00966251|"~     The objective of this pilot study is to evaluate the safety, tolerability and activity of the~     monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular~     Carcinoma.~   "
198389|NCT00966238|"~     A multi-center, open-label, escalating dose-ranging study to assess the safety,~     reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg,~     2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125~     is safe and immunogenic at one or more of the doses tested.~   "
198390|NCT00966225|"~     The purpose of this study is to determine a safe and tolerable dose of LIP-01~   "
198391|NCT00966212|"~     The study has the potential to improve understanding of the link between early alcohol and~     sexual initiation and to provide a proven, selective, female-focused intervention for~     addressing these risks. The goal is to set young women on a course that protects their health~     and reduces the burden that problem drinking and HIV disease is taking on African American~     and Latino communities.~   "
198392|NCT00966199|"~     The purpose of this study is to determine if a reduction in systolic blood pressure induced~     by anti-hypertensive medication results in changes in cerebral perfusion and cognition in~     hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive~     medication for 8-12 weeks. Changes in cerebral perfusion and cognition will be assessed~     before and after treatment.~   "
198393|NCT00966186|"~     The purpose of this study is to compare two insertion techniques of large size ProSeal~     laryngeal mask airway. We hypothesized that insertion of ProSeal laryngeal mask airway with~     90-degree rotation would reduce the contact surface between the device and pharyngeal wall~     and make it easy to advance the device over the smooth angle against the posterior pharyngeal~     wall.We compared the success rate and incidence of complication of the standard technique~     with the rotational technique.~   "
198394|NCT00966173|"~     This is an international, multicenter, prospective, non controlled, non randomized, clinical~     study to collect electrical impedance data of potentially malignant pigmented nevi and~     histological diagnoses (International Melanoma Algorithm Training Study [IMATS]). The study~     objective is to collect data for training and optimization of an algorithm that can classify~     skin lesions using electrical impedance, i.e., to identify malignant melanomas.~   "
198395|NCT00966160|"~     Therapy guidelines recommend the use of either the non-nucleoside reverse transcriptase~     inhibitor (NNRTI) efavirenz or a ritonavir-boostered protease inhibitor (PI) plus 2~     nucleoside reverse transcriptase inhibitors (NRTI) as first-line treatment regimes of HIV-1~     infection. Recent clinical studies suggest potential advantages of NNRTI- over PI-based~     regimes in therapy initiation due to lower rates of virologic failure and less metabolic~     side-effects. In contrast, PI regimes were claimed to cause greater increases in CD4 cell~     count than NNRTI regimes, which has been attributed to intrinsic antiapoptotic effects of the~     PI. However, it is still unclear whether the immunological response to a PI-containing regime~     is greater than to an NNRTI-containing regime, whether there is a difference in the extent of~     reduction of apoptosis between PI and NNRTI regimes and whether a difference in apoptosis is~     associated with a difference in CD4 cell recovery.~      We conducted a controlled, long-term, random matched pair design study in HIV-1 infected~     individuals under sustained virologic suppression to evaluate in head-to-head comparison the~     clinical effects of a constant PI-based or NNRTI-based regime on CD4 cell recovery and the~     underlying molecular, biochemical and functional mechanisms.~   "
198396|NCT00966147|"~     The purpose of this study is to determine whether increasing cardiac output by a combination~     of intravenous fluids and inotropic drugs can reduce mortality and morbidity in radical~     cystectomy operations.~   "
198397|NCT00966134|"~     Regulation of ghrelin, growth hormone and growth factors at high altitude and their change~     during ascent to high altitude has not been studied in depth yet. The study includes 33~     volunteers (12f) investigated at sea level, 4 days after ascent to 3440m and 14 days after~     ascent to 5400-5900m.~      The investigators hypothesized that during ascent growth hormone levels would increase to~     compensate for the higher energy needs at high altitude.~   "
198398|NCT00966121|"~     Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal~     rebleeding. Recently several studies compared the efficacy of EBL alone and with a~     combination of propranolol and EBL. However, the results of recent studies showed~     discrepancy. This study is performed to compare the efficacy and safety of EBL alone and EBL~     combined with propranolol in patients without previous history of endoscopic variceal~     treatment.~   "
198399|NCT00966108|"~     Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring~     with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens~   "
198400|NCT00966095|"~     The purpose of this study is to develop and validate a blood-based diagnostic test that will~     predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will~     serve to reduce the number of unnecessary prostate biopsies.~   "
198402|NCT00966069|"~     The investigators are aiming to learn more about respiratory infections in young children in~     the community. To prepare for a larger project, the investigators are conducting this study~     to get information about the best way to collect and transport respiratory specimens from~     young children. The investigators would like to test whether parents are more likely to~     collect a simple respiratory specimen themselves during a child's illness, compared to the~     likelihood of specimen collection when a home visit is made by a health care worker. Further,~     the investigators want to compare the likelihood a virus will be identified in both groups.~   "
198403|NCT00966056|"~     This study evaluates whether Mitomycin C is an effective alternative to septal splints in the~     treatment of nasal synechiae.~   "
198404|NCT00966043|"~     CYPTAM-BRUT 3 is a prospective, multicentric study in Belgium within the CYPTAM study of the~     Leiden University Medical Center (NTR1509) including postmenopausal women receiving tamoxifen~     for estrogen-receptor positive breast cancer in the adjuvant setting. The primary endpoint is~     the difference in uterine changes between women with a normal versus low TAS after 3 months~     of tamoxifen use. Secondary endpoints are serum metabolite concentrations, serum~     follicle-stimulating hormone level, serum sex hormone-binding globulin level and menopausal~     symptoms. These patients are registered in the Leiden protocol with time to breast cancer~     event as primary endpoint.~   "
198405|NCT00966030|"~     This study will demonstrate the definitive bioequivalence of a solid dose formulation of~     MK0974 to the liquid filled capsule formulation of MK0974.~   "
198406|NCT00966017|"~     The purpose of this study is to develop small molecule radio-labeled probes of beta-amyloid,~     to be used with positron emission tomography (PET) for early detection and treatment~     monitoring of Alzheimer disease (AD). The study hypothesis is that PET imaging of small~     molecule probes, in the form of novel fluorescent dyes with radioactive labels, will~     demonstrate cerebral patterns in patients with AD that are distinct from those of age-matched~     persons who are cognitively intact.~   "
198407|NCT00966004|"~     The purpose of the study is to evaluate the effect of YM178 in patients with overactive~     bladder for 12-week administration.~   "
198408|NCT00965991|"~     Our hypothesis is that metformin and glyburide will have equal efficacy in controlling blood~     glucose in gestational diabetics with no increase in adverse maternal, fetal or neonatal~     outcomes.~   "
198409|NCT00965978|"~     The aim of the study is to evaluate the effects of food intake on the plasma concentration~     profile of YNO-5920/YM529 in post menopausal women.~   "
198410|NCT00965965|"~     The purpose of this study is to determine whether a newly developed patient education~     document concerning colorectal cancer screening will be better understood and have greater~     effects on patient knowledge of and motivation for screening than a standard educational~     document.~   "
198411|NCT00965952|"~     The purpose of this pilot study is to perform a procedure to evaluate the safety of the~     placement of a new device (known as the VFIX device).~   "
198412|NCT00965939|"~     CYPTAM-BRUT 2 is a prospective, multicentric study including postmenopausal women receiving~     tamoxifen for metastatic, locally advanced (stage IIIB/C) or in the neoadjuvant setting for~     measurable estrogen-receptor positive breast cancers. The primary endpoint is the difference~     in efficacy of tamoxifen, defined as the objective response rate using RECIST criteria,~     between women with a normal versus low Tamoxifen Activity Score (TAS) after 3-6 months of~     tamoxifen use. The TAS score is based on the presence of genetic variations and drug~     interactions. Secondary endpoints are time to progression, clinical benefit, serum metabolite~     concentrations, endometrial changes and menopausal symptoms. Patients using tamoxifen in the~     neoadjuvant setting needs being operated between 4-6 months following the start of tamoxifen.~   "
198413|NCT00965926|"~     The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of~     YM178 in healthy, non-elderly adult subjects.~   "
198414|NCT00965913|"~     An investigation on the cumulative skin irritation potential of a newly developed 15 mg~     nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal~     patch.~   "
198415|NCT00965900|"~     This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL~     combined with propranolol in patients with medium or large varices.~   "
198416|NCT00965887|"~     This study will evaluate the bioequivalence of two solid dose formulations of MK0974.~   "
198417|NCT00965874|"~     Objective:~      To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the~     immediate treatment of rapid AF.~   "
198418|NCT00965861|"~     Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical~     research and correlative science. To this end, the SCRI Oncology Research Consortium will~     collect written consent from patients allowing the use of their tumor tissue sample(s) for~     testing/analysis at a future date. Future testing may include assays for newly identified~     markers of potential prognostic and/or therapeutic value. These markers may be specific to an~     individual cancer type, or they may be present more generally in cancer and/or other~     conditions.~   "
198419|NCT00965848|"~     The purpose of this study is to assess the safety and efficacy of doripenem in participants~     with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy;~     pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal~     (in belly) infections and complicated urinary tract infections (bladder infections).~   "
198420|NCT00965835|"~     The purpose of this study is to develop small molecule radio-labeled probes of beta-amyloid,~     to be used with positron emission tomography (PET) for early detection and treatment~     monitoring of Alzheimer disease (AD). The study hypothesis is that PET imaging of small~     molecule probes, in the form of novel fluorescent dyes with radioactive labels, will~     demonstrate cerebral patterns in patients with AD that are distinct from those of age-matched~     persons who are cognitively intact.~   "
198433|NCT00965653|"~     This open-label randomized 2arm study will investigate the pharmacokinetics,~     pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients~     with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients~     will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in~     combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals~     during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.~   "
198421|NCT00965822|"~     Parents with children aged 3-11 will participate in this study. About 500 children will take~     part in the study. We expect about half of those children will develop symptoms of a~     respiratory infection. Active participation in this study will last 14 days after a parent~     reports symptoms of a respiratory infection in a participant. Those children who do meet the~     study criteria of symptoms will then be randomly placed (like a flip of a coin) into one of 2~     groups to take either COLD-FX® or placebo for 3 days. A placebo will look exactly like~     COLD-FX® but contains no active ingredients. The participant has an equal chance of being~     placed in either of the above groups. The study is double-blind, so neither the participant~     nor the study staff will know which study group the participant was placed in until the study~     is completed. If this information is needed in an emergency at any time throughout the study,~     it is quickly available from the sponsor.~      Participation in the study will be for 14 days after symptoms of a respiratory infection are~     reported to study staff. Your child will take the study product for 3 days, you will complete~     a daily diary, receive 4 phone calls and be seen for a final study visit to review the diary~     and complete a final health check of your child.~   "
198422|NCT00965809|"~     Stress Disorder (PTSD) is a chronic and debilitating anxiety disorder which is widespread in~     every social level and is very prevalent in outpatient and inpatient settings.~      A recent open-label study showed that the synthetic cannabinoid receptor agonist Nabilone had~     beneficial effects abolishing or greatly reducing nightmares that persisted in spite of~     treatment with conventional PTSD medications. Furthermore, a big number of patients suffering~     from chronic PTSD report using smoked marijuana because its tranquilizing effect and sleep~     quality improvement. According to clinical and epidemiological data different derivates from~     the cannabis plant are illegally and pervasively consumed by PTSD patients in order to reduce~     distress.~      The aim of the proposed study is to broaden the previous observations and to measure the~     extent to which Δ 9-THC will bring to significant improvement on the full spectrum of PTSD~     symptoms.~   "
198423|NCT00965796|"~     The objective of the present study was to evaluate the effect of intraoperative intravenous~     lidocaine on postoperative pain after hysterectomy.~   "
198424|NCT00965783|"~     To test whether baseline levels of slow wave activity (SWA) during sleep are lower in obese~     adults, and even lower in persons with sleep disordered breathing (SDB) compared to lean~     adults.~      To compare levels of SWA in individuals in relation to their sleep time, blood pressure,~     heart rate, and markers of glucose metabolism.~   "
198425|NCT00965770|"~     It has been shown that the immediate insertion of intrauterine devices (IUDs) post-abortion~     prevents repeat abortions. The researchers hypothesize that providing free IUDs post-abortion~     will be associated with a lower rate of repeat abortion in a Canadian population. Further,~     the researchers hypothesize that providing free IUDs post-abortion will be associated with~     decreased costs for the health care system.~   "
198426|NCT00965757|"~     The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when~     added to ongoing, stable-dose methotrexate therapy in patients with persistently active~     rheumatoid arthritis~   "
198427|NCT00965744|"~     The aim of this trial was to verify the efficiency of a new surgical device (the LigaSure~     vessels sealing system) in esophagogastric decongestion and splenectomy in patients with~     portal hypertension.~   "
198428|NCT00965731|"~     This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone~     versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell~     lung cancer.~   "
198429|NCT00965718|"~     Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte~     (Immuncell-LC) cell therapy in Gemcitabine refractory advanced pancreatic cancer~   "
198430|NCT00965705|"~     Temple University is looking for women to participate in a study to evaluate the treatment~     options available to women living with binge eating disorder.~      Binge-Eating Disorder is a significant public health problem for women. Despite this, there~     is limited research on how best to treat this disorder at varying levels of severity. The~     purpose of this NIMH-funded study is to enroll individuals in a brief form of~     cognitive-behavior therapy. If more intense treatment is needed, individuals will be randomly~     assigned to more intensive group and individual treatments (Cognitive-Behavior Therapy or~     Dialectical Behavior Therapy). Both of these treatments are talking therapies that have been~     adapted for women living with binge-eating disorder and are free of charge.~   "
198431|NCT00965679|"~     Background:~        -  Computed tomography (CT) creates three-dimensional images based on X-ray imaging. CT is~          useful for determining treatment approaches for certain diseases, such as calcific~          aortic stenosis (narrowing of the aorta because of calcium deposits).~        -  Comparing the data received from CT scans with the data received from heart~          catheterization (which assesses the heart's condition and function) can be used to~          improve treatment in patients with certain heart conditions. Researchers are interested~          in looking at the effectiveness of both procedures in assessing possible surgical~          treatments for patients with calcific aortic stenosis.~      Objectives:~      - To analyze cardiac CT scans in conjunction with existing heart scan results to improve~     treatments for future minimally invasive aortic valve replacement.~      Eligibility:~      - Patients 18 years of age and older who have been diagnosed with aortic valve stenosis that~     may be treated surgically, and who will undergo or have recently undergone heart~     catheterization.~      Design:~        -  Participants will have a CT scan within 90 days of the medically necessary heart~          catheterization, but before any other surgical or catheter treatment.~        -  During the CT scan, patients will be asked to hold their breath intermittently for about~          5 to 20 seconds. Patients will be inside the scanner for less than 30 minutes.~        -  Patients will be asked to return in 3 to 7 days for a blood test to check kidney~          function.~        -  Researchers will analyze the results of the CT scan in conjunction with the previous~          results from the catheterization to determine possible improved treatment options.~   "
198432|NCT00965666|"~     The purpose of this research study is to evaluate the safety of the drug Etanercept (Enbrel)~     and to determine if this drug can help in the treatment of early bone marrow failure in~     patients with Fanconi anemia.~   "
198434|NCT00965640|"~     This proof of concept study seeks to demonstrate that Botulinum toxin injections are a safe~     and effective method for treating this form of hair loss.~   "
198435|NCT00965627|"~     This is a retrospective analysis of biological characteristics of thymoma and thymic~     carcinoma patients.~   "
198436|NCT00965614|"~     ECG is one of the most important non-invasive method to diagnose CAD and arrhythmia. However,~     clinically it still has its limitation. Because the electrical field could induce a magnetic~     field, the newly developed non-contact technique, magnetocardiography, was established to~     detect the local magnetic field component of the heart. It is safe and more convenient. In~     this study, we try to define and validate the magnetocardiographic patterns in the patients~     with cardiac arrhythmias or ischemia.~   "
198437|NCT00965601|"~     The investigators are doing this study to better understand the role of the central nervous~     system in processing painful stimuli in patients with fibromyalgia. Specifically, the~     investigators would like to know whether the central nervous system processing of painful~     stimuli changes with time and with talk therapy. In addition, the investigators are~     investigating how changes in your fibromyalgia symptoms may affect certain markers or~     proteins in your blood.~   "
198438|NCT00965588|"~     The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the~     amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients~     diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the~     target antigen based on supporting evidence of the hypothesis that places the accumulation of~     amyloid beta at the initiating step of AD.~   "
198439|NCT00965575|"~     The prevalence of epilepsy is 1% in the USA. About 30% of epilepsy patients eventually become~     refractory to medical treatment. Co morbid conditions are becoming as important as seizure~     control as these affect overall wellbeing. Sleep related complaints are frequent in them~     including, frequent arousals, difficulty falling asleep and excessive daytime sleepiness.~     Polysomnography shows increased arousal index, sleep onset latency, and stage shifts and~     fragmented REM sleep. Poor sleep efficiency causes daytime fatigue, poor cognition and~     behavior and can worsen seizure control. Stabilizing sleep may improve seizure control.~     Melatonin is a naturally occurring hormone in the body involved in the regulation of~     circadian rhythm and exogenously given, has been shown to decrease sleep onset latency,~     arousals, and there-by increase sleep efficiency in healthy pediatric patients. Similar data~     does not exist in the patients with epilepsy. As sleep has important impact on epilepsy and~     overall functioning, it is important to study effect of melatonin in children with epilepsy.~      We propose a randomized double blind placebo controlled trial with a cross-over design. Our~     hypothesis is that, for patients with epilepsy, administration of melatonin 30 minutes before~     bedtime for four weeks may:~        -  Improve the quality of sleep;~        -  Improve daytime functioning in terms of cognition, behavior and quality of life;~        -  Decrease epileptic potential. We will use polysomnography, electroencephalogram,~          psychomotor vigilance task, seizure diary, and questionnaires to assess the effect of~          melatonin on these domains. This study may help to improve the care of children with~          epilepsy.~   "
198440|NCT00965562|"~     The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in~     the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo~     control. Third, to evaluate the efficacy of each treatment for specific symptom clusters~     (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on~     going fluoxetine treatment leads to additional therapeutic benefit.~   "
198441|NCT00965549|"~     The primary objective is to demonstrate the non-inferiority at six months of a basal plus one~     insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin~     regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes.~      The secondary objective are:~        -  To compare the proportion of patients in each treatment group reaching HbA1c target (<~          7%) at the end of the treatment period~        -  To compare the rates of hypoglycaemia (total, severe, nocturnal)~        -  To compare the change in body weight from visit 10 to visit 24~        -  To compare the change in diabetes specific quality of life and other patient reported~          outcomes from visit 10 to visit 24~             -  Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c)~             -  Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire~             -  Insulin Treatment Satisfaction Questionnaire (ITSQ)~             -  EuroQoL 5 Dimensions (EQ5D) questionnaire~        -  To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10~          to visit 24~   "
198442|NCT00965536|"~     The general aim of this non interventional study is to clarify what are the current clinical~     treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release. The~     primary objectives of the study are:1.To collect information on the used Quetiapine Immediate~     Release or Quetiapine Extended Release medication 2.To collect information on duration and~     number of hospitalisation days 3.Change of GAF points~   "
198443|NCT00965523|"~     The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate~     the safety of patients who continue to receive E7389 after completing the Phase II clinical~     study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed~     breast cancer by intravenously administering E7389.~   "
198444|NCT00965510|"~     The purpose of this study is to determine whether it is possible to improve health outcomes~     for patients with Type II diabetes, a community-based health care agency will offer care~     coordination to half of a study group in a family practice office. The intervention will~     include assessing patients' status using two instruments:~      a depression screen (the PHQ9) and a motivation to change scale (the Patient Activation~     Measure, PAM). A masters-level social worker will counsel patients in the intervention group.~     Changes in patients' health status, PHQ9 scores and PAM scores over one year will be~     measured. Outcomes will be compared between the study group and the group without~     intervention.~   "
198445|NCT00965497|"~     The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major~     depressive disorder in patients who have ALS or MS.~   "
198446|NCT00965484|"~     Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and~     preference of Genotropin injection pen. Patients already on genotropin will be asked to use a~     genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire~     at baseline and 2 months.~   "
198447|NCT00965471|"~     The purpose of this study is to built the standard of Chinese Traditional Medicine test for~     Post percutaneous coronary artery intervention and coronary artery bypass graft，also for~     acute coronary syndrome，according to the multi－site、random large sample test.~   "
198448|NCT00965458|"~     The purpose of this trial is to test whether a drug called alefacept will slow or halt~     destruction of the beta cells in the pancreas. If the destruction of the beta cells is~     stopped, the patients might be able to produce insulin on their own longer, which could stop~     or slow the progression of their type 1 diabetes.~      This is a multi-center prospective, placebo-controlled, double-blind and randomized trial to~     investigate the ability of alefacept to protect residual beta cells from ongoing autoimmune~     destruction in adolescents and young adults with newly diagnosed Type 1 Diabetes Mellitus~     (T1DM).~   "
198449|NCT00965445|"~     Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been~     demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The~     aims of this study are(1)to develop an accurate liquid chromatography-tandem mass~     spectrometry methods for the detection of urinary isoprostane isomers in samples collected~     from healthy volunteers(for method quality control) and patients receiving a cardiac surgery~     (2)to investigate the change of isoprostanes after cardiopulmonary bypass(CPB) (3)to~     investigate the effect of different anesthetics on isoprostanes.~   "
198450|NCT00965432|"~     The objectives of this study are to determine the safety and tolerability of single oral~     doses of STX107 and to determine basic pharmacokinetic (PK) parameters following single oral~     doses of STX107 when administered via an oral suspension~   "
198451|NCT00965419|"~     The primary purpose of the study is to assess long-term safety and tolerability of~     Edivoxetine in pediatric participants with attention deficit hyperactive disorder (ADHD).~   "
198452|NCT00965406|"~     The aim of this study is to evaluate the effect of the glucose insulin potassium (GIK)~     infusion associated with intensive insulin therapy compared to GIK alone and control group in~     patients presenting to the ED with acute coronary syndrome.~   "
198453|NCT00965393|"~     Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the~     heart. Current treatments are designed at relieving this blockage as quickly as possible to~     minimize damage to the heart muscle. However in restoring the supply of blood local damage~     known as ischaemia-reperfusion injury may occur. The aim of this study is to assess how~     clot forming and clot dissolving pathways are affected during this process, and examine the~     role of a natural inflammatory hormone, bradykinin. This will help the investigators to~     understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new~     treatments for heart attacks.~   "
198454|NCT00965380|"~     The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody~     spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients~     to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that~     Trinity Evolution combined with an interbody spacer and supplemental posterior fixation will~     result in fusion rates and clinical outcomes similar to those with other routinely used~     autograft and allograft materials including: fusion, improvement in pain and function,~     maintenance of lower extremity neurological function, and absence of serious adverse events~     related to the use of the Trinity Evolution product.~   "
198455|NCT00965367|"~     Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators~     practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would~     therefore be appropriate to consider the use of non-pharmacological methods in preventing~     PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV,~     and the adverse effects are minimal.~      Consequently, the investigators will investigate if acupuncture and acupressure can be~     implemented as a supplementary to the ordinary treatment in children undergoing surgery for~     tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for~     acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion~     decisions are conducted after the intention-to-treat principle. 126 patients are included,~     divided into two groups:~        1. Treatment Group - standard treatment and acupuncture performed after induction of~          anaesthesia, acupressure administered before awakening~        2. Control Group - standard treatment~      The primarily endpoints in this study are nausea, retching and vomiting. The effect of~     acupuncture/acupressure will be studied with regard to any association with possible factors~     of predisposition to PONV, as well as with other factors registered during the study. Adverse~     effects from the acupuncture site and wristband will be registered.~   "
198456|NCT00965354|"~     Influenza A is one of the best studied viruses, but continues to have a very large impact on~     human and animal health. In addition to causing outbreaks of winter flu, it sometimes mutates~     to create a new virus that spreads quickly around the world. It is puzzling that the same~     virus appears to cause minor or absent symptoms in some people while killing others. Much~     remains to be understood.~      We have assembled an unprecedented group of internationally renowned scientists from England~     and Scotland who will together focus on studying a few hundred people hospitalised during the~     current swine flu pandemic. Such a largescale project has never before been attempted, but we~     are now poised to work together and integrate the many recent advances in biomedical science~     that relate to understanding how influenza causes disease.~      The ultimate goal of this collaborative, intensive study is to discover new and effective~     treatments and to develop better vaccines that can be used in future outbreaks. By~     integrating the information that we will gather, we will create a unique overview of how~     influenza causes illness and what might be done to improve patient management.~   "
198457|NCT00965341|"~     The goal of this clinical research study is to learn if and how testosterone replacement~     therapy may affect fatigue in males with advanced cancer and low testosterone levels.~   "
198458|NCT00965328|"~     The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal~     hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for~     intensive care patients with acute renal failure. Up to now it is not known whether~     nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of~     bleeding.~      Aim of the present study is to determine~        1. whether nadroparin accumulates in plasma~        2. whether nadroparin is removed by filtration and whether removal depends on~          hemofiltration dose~        3. the effects of nadroparin during critical illness on coagulation and anticoagulation~   "
198496|NCT00964795|"~     The primary objective is to assess long-term safety and tolerability of Intravitreal~     Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.~   "
198459|NCT00965315|"~     Diabetic patients have an excess risk of mortality due to cardiovascular diseases (CVD)~     compared to non-diabetics. Cardiovascular disease mortality rate is reportedly on the rise in~     several countries in the region, including urban China, Malaysia, Korea and Taiwan.~     Cardiovascular diseases and stroke are always the number 2 and 3 killers for Taiwanese~     population in recent years, and they really cost much from our medical resource. For treating~     dyslipidemia, one of the major risk factor for CVD, statins have been well documented to~     reduce CV deaths both for primary and secondary prevention in several large-scale trials. It~     has been reported that the clinical benefits of treating dyslipidemia in patients with~     diabetes mellitus should be at least equivalent to the benefits observed among those with~     cardiovascular disease. A meta-analysis of seven trials of statins found that treatment for~     about 5 years resulted in a 25% reduction in the combined outcome of coronary heart disease~     death and non-fatal myocardial infarction. Fibrates are another group of hypolipidemic drugs~     that regulate lipid metabolism and are used quite often in daily practice for diabetic~     dyslipidemia, because of its beneficial effect to reduce high TG and increase low HDL-C,~     which are the characteristic lipid abnormalities commonly seen in the patients with diabetes~     or metabolic syndrome. However, in recently published FIELD study, fenofibrate did not~     significantly reduce the risk of the primary outcome of coronary events in 9,795 participants~     with type 2 diabetes mellitus. The higher rate of starting statin therapy in patients~     allocated placebo might have masked a moderately larger treatment benefit. Furthermore, all~     the treatment trials to back up the lipid treatment guideline were conducted in Caucasians~     and no data about the combination therapy with fibrate and statin was published before.~   "
198460|NCT00965302|"~     The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to~     medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with~     medical management, with a primary endpoint of diabetes remission (normal fasting glucose,~     off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature~     gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection~     of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension,~     sleep apnea, c-reactive protein, and fasting lipid profile.~   "
198461|NCT00965289|"~     A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI,~     up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like~     regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who~     achieved at least a PR, ASCT started with a BEAM regimen.~   "
198462|NCT00965276|"~     This study will examine the relationship of a protein called pAKT to survival of breast~     cancer patients with one or more positive axillary lymph nodes. Akt plays a role in cell~     survival, tumor formation, and the development of drug resistance.~      The study will use tumor tissue obtained from 2,000 patients enrolled in a National Surgical~     Adjuvant Breast and Bowel Project study that is evaluating whether adding the drug paclitaxel~     (Taxol (Registered Trademark)) to a treatment regimen of doxorubicin (Adriamycin (Registered~     Trademark)) and cyclophosphamide (Cytoxan (Registered Trademark)) improves disease-free~     survival and overall survival in patients with node-positive breast cancer. The current study~     will measure levels of pAkt in the tissues and correlate the results with clinical outcome to~     see if pAkt levels are associated with improved patient survival.~   "
198463|NCT00965263|"~     Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces~     selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct~     effects is unknown. The objective of this human laboratory study was to measure the~     relationship between antibody titers and the effects of smoked cocaine on ratings of~     intoxication, craving and cardiovascular effects.~      Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks~     inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and~     at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.~   "
198464|NCT00965250|"~     Background:~        -  Cisplatin-containing chemotherapy is the standard of care for advanced thymoma and~          thymic carcinoma that cannot be treated with surgery. New options for treatment are~          necessary in patients with advanced thymoma and thymic carcinoma that have progressed on~          cisplatin-containing therapy.~        -  IMC-A12 is a new (experimental) agent that has not yet been approved by the Food and~          Drug Administration. IMC-A12 blocks the Insulin-like Growth Factor 1 receptor (IGF-1R).~          IGF-1R is found on many types of cancer cells, including cancer of the thymus, and is~          thought to play an important role in helping these cells to grow and divide.~      Objectives:~        -  To determine if IMC-A12 has an effect on tumor growth in patients with cancer of the~          thymus.~        -  To evaluate the safety and tolerability of IMC-A12 in treatment for cancer of the~          thymus.~      Eligibility:~      - Individuals older than 18 years of age who have cancer of the thymus (thymoma, thymic~     carcinoma, or thymic carcinoid tumors) that has progressed in spite of standard treatment.~      Design:~        -  Treatment will take place in 21-day cycles. Patients will receive one dose of IMC-A12~          intravenously once every 3 weeks at the Clinical Center. During the Clinical Center~          visits, researchers will perform study tests and procedures to see how the study drugs~          are affecting the body.~        -  Patients will undergo a number of tests and procedures during the treatment cycle,~          including physical examinations, blood and urine samples for standard tests, imaging~          studies (ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) scans)~          to evaluate tumor growth, and blood and urine samples to evaluate the amount of IMC-A12~          in the body.~        -  Patients may continue to take the drug as long as there are no adverse side effects and~          as long as the tumor does not grow.~   "
198465|NCT00965237|"~     The purpose of this study is to evaluate the use of a multifocal contact lens in people who~     previously wore contact lenses but discontinued due to age-related, near vision demands.~   "
198466|NCT00965224|"~     Dendritic cell therapy is a promising strategy for adjuvant cancer therapy in the setting of~     minimal residual disease (MRD) to fight off cancer relapse and/or progression. The~     investigators already performed a phase I safety study in leukemia patients that were in~     complete remission demonstrating the absence of side effects and feasibility of the therapy.~     Here, the investigators want to extend on this strategy by studying the clinical efficacy of~     autologous DC vaccination in patients with acute and chronic myeloid leukemia and myeloma~     patients. Effects of DC therapy on the immune reactivity towards leukemia cells as well as~     clinical parameters such molecular MRD monitoring, time to relapse (TTR), progression-free~     survival (PFS) and overall survival(OS) will be studied in vaccinated and non-vaccinated~     (control) patients. Patients will be vaccinated using their own dendritic cells~     electroporated with mRNA coding for the full-length Wilms' tumor antigen WT1.~   "
198467|NCT00965211|"~     This is an open study.approximately 20 patients diagnosed with tourette's syndrome and under~     pharmAcological or psychotherapy treatments will participate.patients will be recruited from~     Schneider hospital and all his extensions. subjects would undergo rTMS (repetitive~     Transcranial Magnetic Stimulation) for five days a week, for four weeks,and will be~     clinically evaluated in order to monitor for improvement.~      We anticipate a significant reduction in symptoms severity at the end of the treatment~     compared to study entry.~   "
198497|NCT00964782|"~     The study will test the hypothesis that a single dose of sildenafil can increase the exercise~     capacity of pediatric patients with a Fontan Circulation.~   "
198544|NCT00964158|"~     This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of~     GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.~   "
198468|NCT00965198|"~     Intravenous catheters are placed in nearly every hospitalized patient. These catheters, since~     they are breaks in skin integrity, are potential sources of infection that occur in the~     bloodstream. Bloodstream infections can result in higher rates of death and lengths of~     hospital stay, as well as increase healthcare costs. Blood is drawn or medications delivered~     through a catheter access device attached to the catheter. In looking at new ways to decrease~     infections associated with healthcare, the investigators plan to test whether the use of a~     silver-coated catheter access device (VLINK) compared to the standard, non-coated device~     (CLEARLINK) can reduce infection rates. These devices are identical in design other than the~     silver coating of the VLINK, that imparts a brown color to the device. Silver can prevent the~     growth of bacteria inside the device (biofilm formation) in the laboratory, but this has~     never been proven in patients.~      The investigators propose to do a crossover study in two Emory-owned hospitals (Emory~     University Hospital and Emory University Hospital at Midtown), anticipated to last 10 months.~     Currently, both types of devices, (standard and silver-coated) are FDA approved for clinical~     use and are in use at both hospitals. The investigators plan to have each hospital use only~     one type of catheter access device for a period of time (approximately 5 months), and then~     switch (crossover) to other type of device for the rest of the study. All patients admitted~     to either hospital (excluding newborns and patients with infections attributed to~     hemodialysis catheters) will be enrolled since both devices meet the standard of care. During~     the study, the infection prevention department, as a continuing part of their regular duties~     will measure infection rates. A small subset of catheters that are removed during routine~     clinical care (none will be taken out solely for the study) will be sent to CDC to determine~     the amount of bacteria inside catheters and catheter access devices (look for biofilm).~     Finally, the microbiology lab, again as part of its routine function will determine the rate~     at which blood cultures are falsely positive. All of these measures will be compared using~     statistical methods to see if there is a difference between the standard and silver-coated~     catheter access devices.~      In undertaking this study, the investigators will be using a type of vascular access device~     (valve, not positive pressure) already in use in both hospitals and not changing the delivery~     of care to patients while, in a rigorous, systematic manner, obtaining samples and data for~     analysis.~   "
198469|NCT00965185|"~     In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques less~     vulnerable, will deter plaque progression, and improve endothelial function. In addition to~     known cholesterol-lowering and C-reactive protein lowering effects, immunomodulatory effects~     of statins will lead to a shift from pro-inflammatory monocyte and T cell subsets to less~     atherogenic subpopulations.~   "
198470|NCT00965172|"~     The goal of this clinical research study is to find out if Caphosol® (calcium phosphate)~     mouthwash is more effective than a baking soda solution at preventing and treating mucositis,~     in patients with sarcoma who are to be treated with chemotherapy. The safety of this drug~     will also be studied. Researchers also want to learn about the way calcium phosphate may~     affect mucous membranes.~      The goal of this clinical research study is to see if Caphosol® (calcium phosphate) mouthwash~     is better than baking soda solution in patients with sarcoma who are to be treated with~     chemotherapy . Caphosol will also be studied to see if it lessens the incidence and severity~     of oral mucositis (painful sores in the mouth).~   "
198471|NCT00965146|"~     The purpose of this study is to evaluate the design and functional performance of the~     Scorpio® Cruciate Retaining (CR) Total Knee System.~   "
198472|NCT00965133|"~     The hypotheses of the study are that children / youth with CP will by possibly use of~     technical aids be able to perform high intensity endurance training by walking / running on a~     treadmill, and that this training will improve their health by increased aerobic capacity and~     quality of life.~   "
198473|NCT00965120|"~     Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the~     heart. Current treatments are designed to relieve this blockage as quickly as possible to~     minimize damage to the heart muscle. However in restoring the supply of blood local damage~     known as ischaemia-reperfusion injury may occur. The aim of this study is to assess how~     clot forming and clot dissolving pathways are affected during this process, and examine the~     role of a natural inflammatory hormone, bradykinin. This will help the investigators to~     understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new~     treatments for heart attacks.~   "
198474|NCT00965107|"~     This study is aimed at increasing the safety of the use of anaesthesia in an elderly~     population (> 60 years). Patients with decreased physiological reserve, including all elderly~     patients, have an increased risk of getting an erroneous induction bolus. This project will~     investigate how fast elderly patients (> 60 years) fall asleep during bolus induction of~     anaesthesia with two of the most used hypnotics, thiopental and propofol, evaluated with~     BIS-monitoring and clinical signs of anaesthetic depth. The hemodynamic response will also be~     evaluated.~   "
198475|NCT00965094|"~     The primary objective of this trial is to show non-inferiority of a CNI-free regimen with~     respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate -~     Nankivell method - as compared to the standard CNI-based regimen in de novo renal transplant~     patients.~   "
198476|NCT00965081|"~     The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is~     effective in the treatment of fibromyalgia compared to placebo.~   "
198477|NCT00965068|"~     Background:~      - Autism spectrum disorders (ASD) are developmental disabilities characterized by impaired~     social interaction and repetitive and/or stereotypical behaviors. Research studies suggest~     that some individuals with ASD have very low blood cholesterol levels. This low cholesterol~     level and other abnormal sterol levels may be important markers for~      subtypes of ASD. Providing additional cholesterol to the diets of children with ASD may help~     improve behavior.~      - These findings will guide the medical community in identifying individuals who should be~     tested for sterol disorders. This study will also help researchers learn whether adding extra~     cholesterol to the diet will improve behavioral and other autism spectrum characteristics~     seen in individuals with ASD and low cholesterol.~      Objectives:~        -  To determine cholesterol levels in children with autism spectrum disorders.~        -  To compare behavioral and other characteristics among children who have autism spectrum~          disorders and high, low, or normal cholesterol levels.~        -  To determine whether adding cholesterol to the diet will improve behavioral and other~          characteristics in individuals with ASD and low cholesterol.~      Eligibility:~      - Children between the ages of 4 and 12 who have been diagnosed with an autism spectrum~     disorder.~      Design:~        -  Initial screening study will involve a collection of blood samples (for study purposes~          and cholesterol testing).~        -  Children who have low cholesterol levels will take part in a study in which they will~          receive either cholesterol supplementation or a placebo, and will have detailed physical~          and psychological examinations to measure possible improvement in behavioral or other~          characteristics.~        -  Children who have high or normal cholesterol levels will have further blood samples~          taken, and will undergo an additional set of examinations for comparison purposes.~        -  Researchers may request blood or DNA samples from other family members (parents or~          siblings), which will be collected through blood draws and cheek swabs.~   "
198478|NCT00965055|"~     Response to statin therapy for elevated low density lipoprotein is variable and may be~     influenced by cholesterol absorption. This study will evaluate whether combination therapy~     with atorvastatin/ezetimibe will be superior to atorvastatin alone in subjects who have less~     than 25% LDL reduction on starting dose statin (eg, atorvastatin 10 mg daily or simvastatin~     20 mg daily).~   "
198479|NCT00965042|"~     The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal~     microflora in healthy volunteers.~   "
198480|NCT00965029|"~     Patients with COPD who deteriorate to Respiratory Failure pose a challenge to the intensivist~     both in ventilating an obstructed patient and in weaning from mechanical ventilation.~      Currently there are no accepted extubation criteria in COPD patients that could predict~     successful weaning from mechanical ventilation. In this study we will attempt to correlate~     spirometric data to eventual weaning from mechanical ventilation.~   "
198481|NCT00965016|"~     Background： Cardiopulmonary resuscitation (CPR) with closed-chest cardiac massage has been~     shown that survival to discharge rate is poor. Attempt to increase success, some aggressive~     methods such as extracorporeal membrane oxygenation (ECMO) has been used (also known as~     extracorporeal cardiopulmonary resuscitation, ECPR). Otherwise, anoxic brain injury is~     another issue after CPR. In recent years, some randomized prospective controlled trials of~     induced hypothermia (IH) to 33℃ for 12 to 24 hours has been demonstrated to significantly~     improve outcome in cardiac arrest patients. Because ECMO also could provide hypothermia~     management, we plan this study to evaluate the cerebroprotective effect of ECPR with induced~     hypothermia. We will try to analyze risk factors influencing patient survival and weaning~     from ECPR and the optimal management for this ominous prognosis group.~      Method:~      The patients were recruited into the ECPR group only if they:~        1. in cardiac arrest that necessitated external or open-chest cardiac massage and a large~          amount of epinephrine (＞5 mg) during CPR.~        2. Could not be returned to spontaneous circulation within 10 to 20 min. After ECPR, the~          body temperature was started to be cooled down. Within 3 hours, the patients have been~          well studied to search for potential reason of CPR. If the patients have no heart~          problem or only intervention needed, they can be grouped into 1. Group 2 is the group,~          which some further operation must be delivered. Group 3 is the group who cannot afford~          to receive hypothermia (The physician in charge don't agree the trial.) In~          ECMO-supported patients, two resulting comparisons were of concern: 1) ECMO weaning~          versus nonweaning and 2) survival-to-discharge versus in-hospital death. We attempted to~          identify the risk factors that affected weaning and survival, and we analyzed the effect~          of ECPR with hypothermia on survival.~      Expected result:~      We will prove ECPR with hypothermia is a perfect strategy. And within three groups of the~     patients, ECMO +induced hypothermia will be the most optimal choice.~   "
198482|NCT00965003|"~     To determine if high resolution MRI can detect early invasion of cartilage by laryngeal~     carcinoma, and to determine if high resolution MRI may be superior to conventional MRI~     imaging or CT imaging to detect cartilage invasion.~   "
198483|NCT00964990|"~     The purpose of this study is to evaluate the safety and effectiveness of JNJ-42160443 in the~     treatment of moderate to severe neuropathic pain in patients with a diagnosis of postherpetic~     neuralgia and post-traumatic neuralgia.~   "
198484|NCT00964977|"~     Radiotherapy with or without adjuvant chemotherapy represents an important column of modern~     therapy in advanced squamous cell originated tumours of the head and neck. However to date no~     studies are available which study the effectiveness of radiotherapy in patients with resected~     small tumours (T1, T2) and concomitant ipsilateral metastasis of a single lymph node (pN1)~     for general treatment recommendation. The present study is designed as non-blinded,~     prospective, multicenter randomized controlled trial (RCT) for comparison of overall-survival~     as primary clinical target in patients receiving radiation therapy vs. patients without~     adjuvant radiation following curative intended surgery. Aim of the study is to enroll 560~     adult males and females for 1:1 randomization to one of the two treatment arms~     (radiation/non-radiation. Secondary clinical endpoints are as follows: Incidence and time to~     tumor relapse (locoregional relapse, lymph node involvement and metastatic spread), Quality~     of life as reported by EORTC (QLQ-C30 with H&N 35 module) and time from operation to~     orofacial rehabilitation.~   "
198485|NCT00964964|"~     This trial is conducted in Europe. The aim is to compare changes in blood sugar and the~     number of periods where carbohydrate supplementation is needed to treat low blood sugar,~     during two different treatments with NN1250 (insulin degludec), a soluble insulin basal~     analogue (SIBA) in subjects with type 1 diabetes.~   "
198486|NCT00964951|"~     The purpose of this study is to see how the body reacts to different strengths of the H1N1~     flu shot when it is given with or without an adjuvant. An adjuvant is a substance that may~     cause the body to produce more antibodies when it is given with a vaccine. This study will~     also compare how age affects the body's response to the H1N1 flu shot. In this study, 3~     strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2~     strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the~     same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will~     include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250~     individuals greater than or equal to age 65. Study procedures include: physical exam, blood~     samples, completing a memory aid to record vaccine side effects, medications and daily oral~     temperature. Participants will be involved in study related procedures for up to 13 months.~   "
198487|NCT00964938|"~     The purpose of this study is to evaluate the effects of multisite left ventricular (LV)~     biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the~     effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be~     superior to conventional BiV pacing.~   "
198488|NCT00964912|"~     The purpose of this study is to determine the safety and tolerability of BMS-820836 after~     single doses~   "
198489|NCT00964886|"~     This 12 week placebo controlled clinical trial tests the individual and combined effects of~     an antidepressant medication and cognitive behavioral therapy for chronic back pain.~   "
198490|NCT00964873|"~     An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090~     (ganetespib) in subjects with AML, ALL and blast-phase CML.~   "
198491|NCT00964860|"~     This is a randomized, controlled, examiner-blind, parallel group, four week clinical study~     comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing~     gingivitis.~   "
198492|NCT00964847|"~     The purpose of this study is to compare the effects of 24 weeks of either a blood pressure~     education and walking program versus a yoga exercise program versus the combined intervention~     of blood pressure education and yoga on reducing mild to moderate high blood pressure in~     pre-hypertension and stage 1 hypertension subjects.~   "
198493|NCT00964834|"~     The purpose of this study is to evaluate the safety and tolerability of short-term dosing of~     IV doxycycline when administered concomitantly with IV Valortim in normal healthy human~     subjects.~   "
198494|NCT00964821|"~     RATIONALE: Studying immune response to flu vaccine in patients who have undergone a stem cell~     transplant may help doctors plan the best treatment.~      PURPOSE: This clinical trial is studying flu vaccine to see how well it works in preventing~     infection in patients who have undergone a stem cell transplant and in healthy volunteers.~   "
198495|NCT00964808|"~     Effective treatment of pain after hip fractures is very important but difficult. It is often~     an old patient who has many adverse effects with the use of morphine.~      This is a randomized pilot study where the investigators want to compare Norspan plaster to~     Oxycontin tablets to patients with particular kind of hip fractures. The investigators will~     evaluate mobilization, pain, use of rescue medicine, adverse effects and length of stay. No~     clinical study about the effect of Norspan as acute painkiller has never been done before.~     Can the investigators get the patients mobilized earlier with less adverse effects?~   "
198498|NCT00964769|"~     The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure~     the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA,~     pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after~     immunization (pneumococcal PS vaccine) in children, adults and elderly.~   "
198499|NCT00964756|"~     In spite of surgical and chemotherapeutic advances, long term survival for advanced and~     recurrent gynecologic cancers remains dismal and no curative treatment for recurrent disease~     exists. Novel treatment strategies are needed. This is a study to determine the maximally~     tolerated dose of and toxicities associated with intraperitoneal delivery of an infectivity~     enhanced adenovirus that expresses a suicide gene and an gene that allows imaging of gene~     transfer. This vector will be given in combination with intravenous ganciclovir in patients~     with recurrent ovarian and other gynecological cancers.~   "
198500|NCT00964743|"~     The purpose of this study is to determine the tolerability and side effects of oral sorafenib~     in combination with intrathecal DepoCyt.~   "
198501|NCT00964730|"~     The purpose of this study is to assess whether multiple doses of Talampanel increase the QT~     interval when compared to placebo~   "
198502|NCT00964717|"~     This study aims to examine the efficacy of an Integrative approach utilizing Chiropractic as~     an add-on therapy for the treatment back and neck pain in an emergency department setting~      Chiropractic is well established as an effective treatment for back pain. The investigators~     cumulative experience in Asaf Harofeh Medical Center has shown Chiropractic to be an~     effective therapy for simple back and neck pain in an emergency room (ER) setting.~      This study will examine weather Chiropractic can decrease pain, increase range of motion and~     decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain~     without neurological findings. Chiropractic will be performed as an add on therapy on top of~     analgesic therapy.~   "
198503|NCT00964704|"~     This single arm, open-label study will evaluate the safety and efficacy of Herceptin in~     combination with Avastin and sequential Xeloda in patients with locally recurrent or~     metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy.~     Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every~     three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda~     1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3~     weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until~     disease-progression on second line treatment and target sample size is <100.~   "
198504|NCT00964691|"~     The purpose of this study is to assess the effectiveness of intermittent preventive treatment~     in pregnancy (IPTp) with Sulphadoxine-pyrimethamine compared to chloroquine prophylaxis in~     Honiara, Solomon Islands for prevention of malaria and it's adverse effects in pregnancy.~   "
198505|NCT00964678|"~     The purpose of this study is to determine whether carvedilol treatment of patients with~     pulmonary arterial hypertension and associated right heart failure is safe and results in an~     improved function of the right heart.~   "
198506|NCT00964665|"~     This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg~     positivity. The study is designed to establish a dose response and safety relationship~     sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also~     designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements~     in China.~   "
198507|NCT00964652|"~     Background: Studies about the effects of walking training with additional body load in~     Parkinson's disease (PD) are lacking. There is evidence that the increase of body load during~     treadmill walking improves reflex activity and leg extensor muscle activity, which are~     impaired in subjects with PD.~      Purpose: The purpose of this study was to assess the effects of treadmill walking training~     with additional body load on the ground reaction forces, spatiotemporal, and kinematic~     variables of the gait of subjects with moderate PD.~      Design: This study was an A1-B-A2 single-case. Setting: The evaluation and the training were~     conducted in a movement analysis laboratory, and at the rehabilitation unit of the~     University, respectively.~      Participants: Nine patients with PD (Hoehn and Yahr 2 through 3) and gait disturbances.~      Interventions: Phases A1 and A2 included 6 weeks of gait training on a treadmill with 10%~     increase of normal body mass. Phase B included 6 weeks of conventional physical therapy.~      Measurements: Measures included the ground reaction forces, spatiotemporal, and kinematic~     variables during overground walking, at baseline and after each phase.~   "
198508|NCT00964639|"~     This study is a comparison of postoperative pain in children with cerebral palsy after~     surgery on the hip or femur. One group is treated with p.o. (by mouth) or intravenous (i.v.)~     analgesia, and the other group is treated with local infiltration analgesia with Naropine.~      Pain is measured with r-FLACC, a pain-score validated for children with cerebral palsy.~   "
198509|NCT00964626|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving paclitaxel together with~     cisplatin as first-line therapy and to see how well it works in treating patients with stage~     I, stage II, stage III, or stage IV ovarian epithelial cancer.~   "
198510|NCT00964613|"~     Cataract is a leading cause of Global blindness. After cataract surgery nearly half of the~     people become blind due to posterior capsular opacification. The only solution for this~     problem is LASER capsulotomy. Laser machine is not available in remote areas especially in~     underdeveloped countries. The solution of this problem is surgical capsulotomy which can be~     performed any where.~   "
198511|NCT00964600|"~     The patients planned to go under elective cesarean delivery under general anesthesia are~     randomly assigned to have either bilateral transversus abdominis plane (TAP) block or usual~     standard analgesics after cesarean. Pain score (Verbal Analog Scale VAS) and analgesic~     requirements are recorded. It's supposed that both are significantly reduced in patients~     undergoing TAP block.~   "
198512|NCT00964587|"~     The purpose of this study is to determine if patient education and problem-solving training,~     delivered in self-study, group, and individual intervention modalities, will produce~     substantial improvements in CVD risk profile via improved self management in urban African~     Americans with type 2 diabetes and a high CVD risk profile.~   "
198515|NCT00964548|"~     Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the~     brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain~     arteries) is a known complication after SAH and significantly increases disability and death~     after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown~     that the muscles in the artery wall play a role in cVSP.~      Dantrolene has been FDA approved and extensively used in clinical practice as a muscle~     relaxant for more than 30 years. It has been shown to provide some benefit in animal studies~     of cVSP, as well as in a small number of humans. Therefore, we plan to undertake this study~     to evaluate the safety and tolerability of treatment with dantrolene in patients with cVSP~     after SAH, and to determine the maximal tolerated dose to be used in future studies to~     determine if treatment with Dantrolene can improve the outcome of patients with cVSP after~     SAH.~   "
198516|NCT00964535|"~     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with~     the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.~   "
198517|NCT00964522|"~     The purpose of this study is to evaluate the effects of a nurse education and care program~     for patients with breast cancer, in terms of use of the health services, quality of life,~     satisfaction and security.~      Hypothesis:~      Nurse education and care program will reduce the use of health resources and will improve the~     toxicity, quality of life and satisfaction of the patients with breast cancer who initiate~     chemotherapy.~   "
198518|NCT00964496|"~     Background: Repeated episodes of bleeding from gastrointestinal vascular malformations~     refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.~      Methods: The investigators performed a randomized, parallel controlled study of thalidomide~     as a therapy for recurrent gastrointestinal bleeding due to vascular malformation. Patients~     with at least six episodes of bleeding in the prior year due to vascular malformation were~     randomly grouped, prescribed a four-month regimen of either 25 mg of thalidomide or 100 mg of~     iron orally four times daily, and monitored for at least one year. The primary end point was~     defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months and the~     cessation of bleeding. Rebleeding was defined based on a positive fecal occult blood test~     (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary~     outcomes included the participants dependent on blood transfusions and changes from baseline~     in transfused packed red cell units, bleeding episodes, bleeding durations, and hemoglobin~     levels at 12 months. Statistical significance was defined at P < 0.05.~   "
198519|NCT00964483|"~     A diet that is rich in fruits, vegetables, and low fat dairy foods is known to lower blood~     pressure in adults. This research project seeks to promote the adoption of the Dietary~     Approaches to Stop Hypertension(DASH)eating pattern by African American adults with~     hypertension or prehypertension living in a lower income minority community. The randomized~     trial phase of this project will test a group-based intervention using materials adopted from~     prior studies and tailored to the community of interest.~   "
198520|NCT00964470|"~     The purpose of this study is to compare the rate of healing and the non-adherence of three~     types of dressings. The study will also compare rate of infection, scarring and perception of~     pain associated with treatment.~   "
198521|NCT00964457|"~     response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced~     rectum cancer~   "
198522|NCT00964444|"~     This study is an observational study to prove that a new device, which measures the force of~     delivering a baby, (US patent 6,684,165) functions as described in the patent. This is the~     first time this has been used with patients.~   "
198523|NCT00964431|"~     The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are~     safe and effective for the treatment of dental pain.~   "
198524|NCT00964418|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood~     glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type~     1 diabetes.~   "
198525|NCT00964405|"~     This is a randomised, double blind, placebo-controlled, 2-parts study to investigate the~     safety, tolerability, and pharmacokinetics of single and repeat inhaled doses of GSK233705~     from a novel dry powder device in healthy Japanese male subjects.~   "
198526|NCT00964392|"~     The purpose of this registry is to provide additional corroborative short-term safety and~     long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters~     in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).~   "
198527|NCT00964379|"~     This is a prospective randomized trial of intraperitoneal versus extraperitoneal techniques~     for construction of terminal iliac fossa colostomies.~   "
198528|NCT00964366|"~     This is a randomized, half-face study. On 1 side of the face, the subject will apply 1 of the~     2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side~     of the face will remain non-treated to serve as a control.~   "
198529|NCT00964353|"~     The purpose of this study is to explore how knowing genes that individuals inherit from their~     parents can make warfarin dosing more safe and effective. This study is being done to~     determine whether providing doctors with data on the genes their patients inherited and~     warfarin dosing recommendations based on those genes affects the costs and outcomes of care~     and after hospitalization for patients from different ethnic/racial backgrounds, and how~     physicians use this information in decision making.~   "
198530|NCT00964340|"~     The primary objective is to determine the pharmacokinetics, safety and tolerability of~     SRT2104 in healthy elderly subjects following single and 28 days dosing.~      The secondary objectives of the study are:~        1. To contrast changes in leg muscle function following repeat doses of SRT2104 or placebo:~           Endurance exercise tolerance 31P MRS measures of mitochondrial oxidative capacity in the~          gastrocnemius muscle~        2. To test for a change in the ratio of visceral to subcutaneous body fat following repeat~          doses of SRT2104 relative to placebo using MRI~        3. To estimate any changes in insulin sensitivity (using mOGTT) following repeat doses of~          SRT2104 or placebo~        4. To test for dose-related effects on the exploratory pharmacodynamic measures above~   "
198682|NCT00962299|"~     The aim of the study is to investigate whether inhaled corticosteroids after a first hospital~     admission for acute dyspnea and wheeze is effective in reducing subsequent episodes of these~     complaints in children aged 1 to 4 years.~   "
198531|NCT00964327|"~     The purpose of this study is to determine the antiviral activity, safety and tolerability of~     14 days of different doses of TMC114 to treat HIV-1 positive patients whose condition is~     failing on a current treatment regimen that includes a protease inhibitor (PI) (a medication~     used to reduce the amount of HIV virus in the blood).To be considered for the study, patients~     must have a documented resistance to at least 2 of the current PIs. Pharmacokinetics and~     pharmacodynamics of TMC114 will also be assessed.~   "
198532|NCT00964314|"~     The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM)~     five elements music therapy improving quality of life for patients with advanced cancer, as~     well as establishing the standard operating procedures (SOP) for it.~   "
198533|NCT00964301|"~     The investigators will implement an interactive school-based telemedicine education program~     for rural low-income, minority children with asthma, their caregivers, and school nurses in~     the Delta region of Arkansas.~      Specific aims:~        1. The investigators will examine changes in asthma symptoms control and other health~          outcomes such as activity levels and family/child emotional health in the intervention~          group compared to a usual care group.~        2. The investigators will examine changes in asthma knowledge, self-efficacy, and quality~          of life in the intervention participants and their caregivers compared to a usual care~          group.~   "
198534|NCT00964288|"~     This study is being conducted to assess the effects of GSK1014802 and a positive control,~     lidocaine, on tests of peripheral nerve excitability. This will be a double blind, placebo~     controlled, 4-period cross over study. Approximately 20 subjects will be randomised to one of~     two doses of a GSK1014802, lidocaine and placebo with at least 2 weeks between sessions. A~     follow-up will occur 7-15 days after the last dose.~      During treatment session 3 on the 6th October 2009, one subject had a pattern of AEs of~     severe intensity, suggestive of brain stem toxicity / encephalopathy during the~     lidocaine/saline infusion period. Although recognised in the literature when lidocaine was~     used in patients for treatment of pain, these AEs were unusual in studies in healthy~     subjects. The study was suspended to allow re-evaluation of the risk:benefit balance of~     lidocaine/saline infusion in healthy subjects in this study. It was decided that continuation~     of the use of lidocaine (positive control) would risk the safety of subjects. Continuation~     without the positive control was not possible as it would compromise the scientific integrity~     of the design.~   "
198535|NCT00964275|"~     RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography,~     may help find and diagnose cancer. It is not yet known whether standard diagnostic procedures~     are more effective when given with or without fludeoxyglucose F 18 positron emission~     tomography in finding cancer.~      PURPOSE: This randomized clinical trial is studying fludeoxyglucose F 18 positron emission~     tomography given together with standard diagnostic procedures to see how well it works~     compared with standard diagnostic procedures alone in finding cancer in patients with a blood~     clot in a vein.~   "
198536|NCT00964262|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics~     of SR exenatide (PT302) in healthy subjects.~   "
198537|NCT00964249|"~     This is a randomized, double blind, placebo controlled, parallel-group, 7 day repeat dose~     study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     inhaled dose of GW642444M from a novel dry powder device in healthy Japanese male subjects.~   "
198538|NCT00964236|"~     The objective of the study is to determine whether Kuvan™ (sapropterin) improves the strength~     of the functional connectivity between brain regions in individuals with PKU.~   "
198539|NCT00964223|"~     Multi-center, single-blind, randomized, comparative, split-face study. The duration of the~     study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and~     benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion~     (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3,~     subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face~     for an additional 6 weeks.~   "
198540|NCT00964210|"~     A research project is currently being undertaken looking at Human Papilloma Virus (HPV)~     vaccination in special risk groups. It aims to see if young women with a chronic illness~     respond well to the HPV vaccine or whether they may require additional doses to ensure~     protective immunity. The four valent HPV vaccine protects against HPV types 16 & 18, cervical~     cancer and HPV types 6 & 11, anogenital warts.~      The six special risk groups include:~      Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia~     Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow~     Transplants This immunity is measured by antibody levels of the HPV types, which requires a~     single blood test one month after the final dose of HPV vaccine.~      This is compared to healthy controls using antibody response to HPV vaccine. This will assess~     directly whether these special risk groups respond as well to the HPV vaccine.~   "
198541|NCT00964197|"~     FemmeJock is a pelvic floor support system developed by pelvic floor physiotherapists for~     patients with pelvic organ prolapse in order to ameliorate symptoms of pelvic floor pressure~     and discomfort. The device is a girdle to be worn on the outside of underwear. The device is~     machine washable and there are no documented risks with wearing it. This product is currently~     being used by pelvic floor physiotherapists and has been subjectively reported by individual~     accounts as being successful in improving pelvic floor symptoms. The efficacy of this product~     has not been previously studied in women with pelvic organ prolapse. The investigators are~     proposing a pilot study with the following specific aims:~        1. to assess patient satisfaction and continuation of use of the FemmeJock support system~          after 3 months of treatment.~        2. to describe, if any, the reasons for discontinuation associated with the use of this~          product, and~        3. to assess whether women experience improvement of pelvic floor symptoms after using this~          product.~   "
198542|NCT00964184|"~     This is a phase IV study of 3.5 years duration to evaluate the phenotypic and genetic~     correlates of diabetes (non-Type 1 in young non-obese Asian Indians in North India and pilot~     case control study to evaluate the efficacy of sitagliptin (DPP-4 inhibitor) in a sub-group~     of the study population.~   "
198543|NCT00964171|"~     RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well efavirenz works as second-line therapy in~     treating patients with metastatic pancreatic cancer.~   "
198545|NCT00964145|"~     The purpose of the study is to characterize the levator ani structures (pubovaginalis,~     puboperinealis, puboanalis, puborectalis, and the iliococcygeous) using 3-D ultrasonography~     in nulliparous women 21-70 years old.~      Hypothesis 1: Prevalence of abnormalities in levator ani muscle structure will be associated~     with increasing age independent of vaginal parity. To investigate the age-related symptoms of~     pelvic floor dysfunction in nulliparous, women 21-70 years old.~      Hypothesis 2: Anatomical abnormalities of the levator ani muscles will be associated with~     symptomatic pelvic floor dysfunction. To investigate the age-related pelvic floor function in~     nulliparous, women 21-70 years old.~      Hypothesis 3: Age-related anatomical abnormalities of the levator ani muscles will be~     associated with levator ani muscle weakness.~   "
198546|NCT00964132|"~     The purpose of this study is to determine whether NRX 194204 is effective in the treatment of~     advanced Non-Small Cell Lung Cancer (NSCLC).~   "
198547|NCT00964119|"~     This is a prospective study, that will follow participants over their course of treatment on~     Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are~     registered in iPLEDGE. The iPLEDGE program involves a set of steps that the patient,~     physician and pharmacist must follow for the patient to take Isotretinoin. Patients will be~     asked if they are willing to participate in this research study to determine musculoskeletal~     changes in adolescents and young adults on systemic therapy using the highly sensitive~     magnetic resonance (MR) imaging modality. In addition to the MRI, participants will be asked~     if they are willing to give an extra sample of blood when their routine blood work is being~     done for iPLEDGE. This blood sample will be used to determine if there are any effects of~     isotretinoin on bone turnover markers.~   "
198548|NCT00964106|"~     The purpose of this study is to identify and validate a probe cocktail for use in future~     drug-drug interaction studies. Cytochrome P450 enzymes and transport proteins play important~     roles in the disposition of drugs. Changes in the activity of these pathways can be assessed~     using probe drugs selected on the basis of their metabolic or transport pathway. This will be~     a two part study with the same subjects participating in both parts to decrease variability~     in data. The purpose of Part 1 is to identify a set of probe drugs ('cocktail') which do not~     interact with one another; groups of healthy volunteers will receive 7 probe drugs~     individually and as a combination of the 7 drugs given together as a cocktail. Part 2 will~     assess the performance of the probe cocktail using three known inhibitors (validation). The~     inhibitors plus probe cocktail will evaluate the ability of the newly established cocktail to~     accurately quantify metabolizing enzyme or transporter inhibition, representing a fundamental~     advance in probe cocktail validation and utility for drug development.~   "
198549|NCT00964093|"~     The purpose of this study is to determine whether silver alginate (Algidex) patch is~     effective in the prevention of central line infections in very low birth weight infants.~   "
198550|NCT00964080|"~     The ongoing study is a Phase II, open-label study to evaluate the efficacy of MBP-426 at a~     dose of 170 mg/m2 in combination therapy in patients with second line metastatic gastric,~     gastro-esophageal junction or esophageal adenocarcinoma.~   "
198551|NCT00964067|"~     The purpose of the study is to compare home-based aerobic interval training with supervised~     interval training performed in groups or on a treadmill at the hospital.~   "
198552|NCT00964054|"~     This pilot study may yield important research findings on how to adapt exercise treatment for~     depression among adolescents. Potential public health benefits from this study include a~     reduction of adolescent depression and problems associated with untreated depression in young~     adults including suicide, substance abuse, cigarette smoking, teen pregnancy, impaired~     psychosocial functioning and school failure. In addition, because this study prescribes~     physical activity as a treatment for depression, additional public health benefits may~     include a reduction in chronic diseases such as obesity, diabetes and heart disease, all of~     which are associated with sedentary behavior.~   "
198553|NCT00964041|"~     This is a parallel-group, placebo-controlled trial examining the cognitive effects at weeks~     1, 4, & 8 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for~     8 weeks in adult outpatients with schizophrenia.~   "
198554|NCT00964028|"~     This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a~     three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.~   "
198555|NCT00964015|"~     When people undergo major surgery, they require intravenous supplementation of fluids for a~     number of reasons:~        -  to compensate for no oral intake~        -  to support blood pressure and organ function during and after surgery~        -  to replace lost fluid or blood volume~      There are a variety of fluid choices doctors have to provide to patients, and it is still not~     definitively known whether some fluids are better than others in specific situations. This is~     a particularly interesting question in patients undergoing heart surgery because of the~     significant volume of fluids used over the entire course of hospitalization, including before~     the operation, during the operation, and after the operation.~      There has been some scientific evidence that the use of starch-based fluids (synthetic~     colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given,~     providing for better recovery from surgery. However, there has also been some scientific~     evidence that the use of these fluids can harm kidney function. Importantly, none of these~     large-scale studies were carried out specifically in patients undergoing heart surgery.~      The purpose of this study is to answer the question of whether the use of starch-based fluid~     in the heart surgery patient makes for a safer and faster recovery, causes kidney~     dysfunction, or makes no discernable difference.~   "
198556|NCT00964002|"~     RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with~     metastatic prostate cancer.~   "
198557|NCT00963989|"~     The primary objective of this clinical evaluation is to determine the safety and~     effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from~     symptom and with a known core infarct volume at admission. The secondary objective is to~     determine if there is a correlation between infarct volume and functional outcome in treated~     patients at 90 days post-procedure.~   "
198802|NCT00960687|"~     This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145~     mg fenofibrate tablets in healthy volunteers when administered following a breakfast of~     standard composition. Safety and tolerability of this regimen will also be evaluated.~   "
198558|NCT00963976|"~     Rationale: Management of blood pressure (BP) in the acute phase of intracerebral hemorrhage~     (ICH) remains controversial. Although it has been established that there is a transient~     moderate reduction of perihematoma cerebral blood flow (CBF) in acute ICH, the effect of BP~     treatment is unknown. The potential for exacerbation of CBF has precluded routine aggressive~     BP reduction.~      Aim and Hypothesis: The primary study aim is to demonstrate the feasibility and safety of~     acute BP reduction to < 150 mmHg systolic using a standardized protocol in ICH patients. It~     is hypothesized that CTP will not demonstrate evidence of perihematoma ischemia following~     acute BP reduction.~      Design: ICH ADAPT is a randomized blinded endpoint trial. Acutely hypertensive ICH patients~     are randomized to a target systolic BP of < 150 mmHg or < 180 mmHg. Patients are treated with~     intravenous (IV) labetalol/hydralazine/enalapril.~      Study Outcomes: The primary outcome is cerebral blood flow in the perihematoma region,~     measured with CT perfusion, 2 hours after randomization. Secondary outcomes include the~     difference in BP at 1 and 2 hours post-randomization in the two treatment groups and hematoma~     expansion rates at 24 hours.~      Discussion: ICH ADAPT is the only randomized trial designed specifically to identify any~     hemodynamic changes in the perihematoma region secondary to aggressive BP management. The~     results of this trial will facilitate ongoing and future studies aimed at determining the~     efficacy of rapid BP reduction in acute ICH.~   "
198559|NCT00963963|"~     This study is developing and testing an innovative, parent education intervention, Preparing~     Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among~     African American and other Black youth living in high-poverty urban neighborhoods.~     Investigators, working with a community advisory board and focus groups of youth and parents,~     will develop a multi-year set of audio-CDs to promote positive parenting practices that~     support young adolescents in establishing healthy patterns of behavior. This parent education~     intervention will be tested in a field trial with families of 6th graders recruited from~     multiple schools in New York City. Baseline and annual follow up surveys will be conducted~     until youth enter high school. Families receiving the intervention will be compared to those~     assigned to either an attention-controlled print materials condition or a non-attention~     controlled condition. It is hypothesized that youth whose parents receive the intervention~     will delay sexual initiation and report fewer sexual risks, and that their parents will~     report more positive parenting practices.~   "
198560|NCT00963950|"~     A safe and effective transvaginal approach accessing the abdominal cavity through the vagina~     rather than the abdominal wall is today considered a routine approach for many gynecologic~     surgeries.~      First described by Dr. Ott in Germany in 1901, it is used routinely for transvaginal surgery,~     for example, transvaginal hysterectomies. This transvaginal technique has been shown to~     compare favorably to a laparoscopic abdominal approach because of less postoperative pain,~     the total elimination of abdominal wall hernias and wound infections, earlier recovery and~     better cosmesis.~      Although routinely used in gynecological surgery, the advantages of the vaginal approach have~     not been utilized for general surgery applications such as cholecystectomies. Open or~     laparoscopic cholecystectomy accessing the abdominal cavity through abdominal wall incisions~     is currently still considered the standard of care in general surgery for patients with~     symptomatic gallbladder disease.~      The investigators intend to access the abdominal cavity through the posterior vaginal fornix~     instead of the transabdominal approach that is now performed routinely. So far, this method~     of accessing the abdominal cavity through the transvaginal approach for the purpose of~     performing intraabdominal general surgery.~      The investigators' transvaginal approach has the strong potential to further decrease~     invasiveness and take minimally invasive surgery to the next level in order to benefit the~     patient even more by minimizing postoperative pain, eliminating the risk of abdominal hernias~     and wound infections, improving cosmetic appearance and enabling the patient to return to~     routine activity and work earlier. First preliminary studies show these advantages but~     further research needs to be done to confirm these early positive results.~   "
198561|NCT00963937|"~     The purpose of this study is to evaluate the efficacy and safety of a range of doses of oral~     sumatriptan for the acute treatment of migraine in children ages 10 to 17.~   "
198562|NCT00963924|"~     This study seeks to examine the effects of D-cycloserine augmentation on cognitive~     remediation for patients diagnosed with schizophrenia. We will test the hypotheses that~     D-cycloserine will significantly improve cognitive performance, negative symptoms, and~     measures of functioning compared to placebo when combined with eight weeks of cognitive~     remediation. We expect that these effects will persist when assessed at six-month follow up.~   "
198563|NCT00963911|"~     RATIONALE: A screening questionnaire may help doctors plan better treatment for older~     patients with cancer.~      PURPOSE: This clinical trial is studying a questionnaire in screening older patients with~     cancer.~   "
198564|NCT00963898|"~     The aim of this study is to evaluate benefits of the method of dental sedation using Target~     controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with~     Mental Retardation and challenging behavior.~   "
198565|NCT00963885|"~     This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with~     RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and~     Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus~     infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591~     300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12~     hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety~     and virological response data from Part 1 of the study are supportive, in Part 2 patients~     will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12~     hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys~     and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample~     size is 100-500 individuals.~   "
198578|NCT00963716|"~     A new electrocautery bronchoscopy biopsy forceps is now commercially available and may~     prevent bleeding following biopsy. Only one study used this device wherein the authors~     concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have~     a negative impact on the pathological samples, and that there was a statistically~     significant, albeit clinically insignificant reduction in bleeding score with hot biopsy~     forceps. Therefore, a randomized controlled study is required in which the hot and cold~     biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on~     histopathological diagnosis.~   "
198566|NCT00963872|"~     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor~     umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect).~      PURPOSE: This phase I trial is studying the safety of donor umbilical cord blood transplant~     after fludarabine phosphate, cyclophosphamide, and total-body irradiation in treating~     patients with high-risk hematologic cancer (now closed).~      The Phase II part of this trial is studying whether priming one of two UCB units with C3a~     facilitates engraftment of the treated unit.~   "
198567|NCT00963859|"~     The goal of this clinical research study is to evaluate how many lymph nodes are left behind~     after robotic-assisted removal and are then found after a wider incision is made, in patients~     who are having their bladder removed for the treatment of bladder cancer.~      The primary objective is to compare the lymph node yield achieved by performing a~     robotic-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) compared to a~     second-look open lymph node dissection (O-PLND) among patients undergoing radical cystectomy~     for transitional cell carcinoma of the bladder.~      The secondary objectives will be to collect prospective outcomes data related to the~     performance of RA-PLND and robotic-assisted cystectomy (RA-C) including operative times,~     estimated blood loss, transfusions, complications, return to diet, utilization of pain~     medication, hospital length, return to regular activities.~   "
198568|NCT00963846|"~     Huperzine is a natural plant product with procognitive properties in patients with~     Alzheimer's disease. Cognitive difficulties hamper functioning in schizophrenia as well. The~     present study will investigate whether huperzine improves cognition and functioning in~     patients with schizophrenia.~   "
198569|NCT00963833|"~     Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but~     approximately 5% of all MS cases worldwide involve children that are younger than 16 years.~      The aim of care of children with Multiple Sclerosis is to prevent or at least to delay any~     neurological and cognitive impairment as well as progression of the disease as far as~     possible. Therefore, it is very crucial to diagnose the disease at an early stage as~     immunomodulatory treatments are available that can delay the progression of Multiple~     SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS~     and being 12 years or older has been approved by the health authorities. The aim of this~     observational study is to obtain further data on the safety, tolerability, and effectiveness~     of Betaferon® under daily living conditions.~      As this is a non-interventional observational study, routine clinical practice is observed.~     The application of diagnostic measures and medications as well as physician visits follow the~     normal routine and is decided upon by the treating physician under recognition of the package~     insert.~   "
198570|NCT00963820|"~     The primary objective of this study is to determine the safety profile, tolerability, and~     maximum tolerated dose of ixazomib citrate (MLN9708) when taken orally on a weekly dosing~     schedule by patients with relapsed and refractory multiple myeloma (RRMM). Secondary~     objectives include pharmacokinetics and response rates.~   "
198571|NCT00963807|"~     This study is being done to compare a special type of Positron Emission Tomography (PET) scan~     with CT scan in patients with surgically removable lung cancer to see which method is more~     useful in measuring a response to treatment. A PET scan uses small amounts of radioactive~     material injected into the blood to show the internal workings of the body. In this study, we~     will use two radioactive materials: 18F-FLT (referred to as FLT) and 18F-FDG (referred to as~     FDG). FDG is used routinely in the staging of lung cancer and is approved by the FDA for that~     purpose. FLT is used in the special type of PET scan being assessed by this study. In~     addition the study will assess the effects of the combination of docetaxel and cisplatin~     (chemotherapeutic drugs) on certain pathological characteristics of the tumor. The~     combination of docetaxel and cisplatin is approved by the Food and Drug Administration (FDA)~     for the treatment of advanced/metastatic NSCLC (non-small cell lung cancer). It is not~     approved for use in patients who have surgically removable NSCLC. In such cases cisplatin is~     used as a single drug therapy before surgery. The FDA is allowing the use of docetaxel along~     with cisplatin in this research study.~   "
198572|NCT00963794|"~     The aim of the present prospective study was to evaluate the prediction accuracy of~     electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively~     enrolled in the investigators' Institute and subjected to electromagnetic detection followed~     by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was~     attributed to subjects showing an electromagnetic signal < 50 units (U).~   "
198573|NCT00963781|"~     Despite the benefit of drug-eluting stents (DES) to reduce the need for repeat~     revascularization procedures, concerns regarding late stent thrombosis (ST) have led to~     recent guidelines advocating extended prescription of dual antiplatelet therapy (DAPT) with~     aspirin and a thienopyridine (clopidogrel or ticlopidine]) beyond that described in the~     product labeling. Specifically, an advisory has recommended at least 1 year DAPT following~     treatment with DES in patients without contraindications. However, this recommendation was~     largely empiric and not based on any trial showing reductions in ST with long-term DAPT, nor~     are potential safety differences between DES considered. Further, no study has examined the~     balance in potential efficacy with long-term DAPT relative to an increased bleeding risk.~      A consistency across clinical trials involving the Endeavor DES has been very low rates of~     late myocardial infarction, cardiac death and ST. Unlike other DES, recent studies indicate~     that the Endeavor stent may permit more rapid and complete healing over stent struts in~     addition to restoring normal blood vessel function. Further, in patients treated with the~     Endeavor stent, long-term safety outcomes are similar through 3 years follow-up irrespective~     of whether patients were adherent to DAPT for durations of ≤ 6 months, 12 months or 24~     months.~      In this study, long-term safety and effectiveness will be examined for patients treated with~     the Endeavor stent and assigned to DAPT for reduced duration of 6 months. If the study~     demonstrates safety and efficacy, it could influence treatment guidelines in favor of an~     abbreviated duration of DAPT for patients treated with the Endeavor stent. This would mean~     that should a bleeding complication or need or surgery arise less than 12 months post-PCI,~     patients treated with the Endeavor stent could stop DAPT after 6 months with reasonable~     estimate of safety. Furthermore, it is possible that patients who are currently denied DES~     due to known need for elective surgery could be treated with the Endeavor stent in cases~     where surgery can be temporarily delayed. Finally, it could be an additional option for~     patients who forgo treatment with DES in favor of bare metal stent (BMS) out of fear of~     possible bleeding with long-term DAPT.~      Finally, it is recognized that not all patients respond the same way to anti-platelet~     therapy. Recent studies have indicated that inherited genetic variations in the way the body~     metabolizes anti-platelet medications may be important determinants of responsiveness to~     thienopyridine therapy, and that such differences may also confer a higher likelihood of~     adverse outcome. Patients agreeing to the additional genetic sub-study will have a DNA sample~     taken at baseline to test for the presence of such genes related to antiplatelet therapy~     metabolism and effectiveness. The results of these tests could help the medical community to~     better understand individual variation in response to anti-platelet therapy and the role that~     genetics may play in determining the response. It is possible that the information gained~     could help physicians tailor DAPT on a patient by patient basis.~   "
198574|NCT00963768|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie,~     blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of~     JNJ-28431754 compared to placebo in patients with Type 2 diabetes mellitus.~   "
198575|NCT00963755|"~     The purpose of this study is to demonstrate that realization of guided biopsies by multimodal~     imaging with 18F-fluorocholine PET / CT and MR Imaging/spectroscopy would allow to increase~     the rate of detection prostate cancer compared with the current approach and give an~     information about location and tumoral volume before surgery.:~   "
198576|NCT00963742|"~     The objectives of this multi-center clinical investigation are to determine the safety and~     effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one~     year of post-operative assessment.~   "
198577|NCT00963729|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Estrogen can stimulate~     the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by~     reducing the production of estrogen. It is not yet known whether giving more than one drug~     (combination chemotherapy) or giving letrozole before surgery is more effective in treating~     women with breast cancer.~      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before~     surgery to see how well it works compared with letrozole given before surgery in treating~     postmenopausal women with breast cancer that can be removed by surgery.~   "
198579|NCT00963703|"~     The purpose of this study is to determine how well Rituximab works in early stages of disease~     and the effects it has on an inflamed joint and blood cells.~      This will allow the investigators to get a better understanding of how this treatment affects~     the inflamed joints of rheumatoid arthritis (RA) patients.~   "
198581|NCT00963677|"~     Difficult airways is still a challenging issue for the anesthesiologists in spite of the~     development of various techniques.Shikani optical stylet(SOS), combining the features of~     fiberoptic bronchoscope and a lightwand, has been used for orotracheal intubation with~     difficult airways. As compared with fiberoptic bronchoscope, SOS is less expensive, easy to~     learn and more durable. However, it remains elusive whether SOS can be used in the~     nasotracheal intubation in the oral and maxillofacial surgery, which normally requires the~     nasotracheal intubation. The present study evaluates the safety and efficacy of SOS for~     nasotracheal intubation in the oral and maxillofacial surgery requiring nasotracheal~     intubation.~   "
198582|NCT00963664|"~     The purpose of this study is to determine whether an outpatient combination of lovastatin and~     low-to-moderate dose interferon is effective in the treatment of patients with malignant~     melanoma.~   "
198583|NCT00963651|"~     To perform a multiple reader, multiple case (MRMC) observer study assessing the detection~     performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.~   "
198584|NCT00963638|"~     The goal of this study is to evaluate the effectiveness of magnesium supplements (MagTabSR~     168 mgs twice daily) for relief and/or improvement in the frequency, duration, and intensity~     of chronic leg cramps. Improvement in sleep disturbances and quality of life will also be~     evaluated.~   "
198585|NCT00963625|"~     This study tests the hypothesis that controlled ovarian stimulation impairs endometrial~     receptivity in normal responders.~   "
198586|NCT00963612|"~     Liver resection and liver transplantation are the acceptable treatment of Hepatocellular~     Carcinoma (HCC). But the long-term survival is unsatisfactory as a result of high rate of~     intra and extra hepatic recurrences. Microvascular invasion (MVI) is the most significant~     risk factor affecting recurrence-free survival in patients following liver resection and~     liver transplantation. Tumor hypoxia (lack of adequate blood supply) is the single most~     important factor that predict MVI and post surgical prognosis.~      Blood Oxygen Level Dependent (BOLD) MRI is a non-invasive diagnostic method of assessing~     tumor hypoxia by detecting signal changes secondary to changes in blood flow and oxygenation.~     BOLD MRI assessment of tumor hypoxia in HCC has never been correlated with pathological~     confirmation of MVI, the gold standard to assess MVI in HCC. In this study, the investigators~     propose to assess the ability of BOLD MRI to provide a discriminating quantitative threshold~     of intratumoral oxygenation predictive of MVI.~   "
198587|NCT00963599|"~     This study will evaluate the ability of oral montelukast/loratadine to improve the signs and~     symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and~     placebo.~   "
198588|NCT00963586|"~     Rationale: Due to advanced technologies in the last decade, increasingly more treatment~     options are available for head and neck cancer (HNC). As a consequence decision-making with~     regard to choosing the best available treatment option is becoming increasingly relevant.~     Quality of life weights (utility scores) are an important outcome measure in this~     decision-making process. Utility scores can be combined with life expectancy, resulting in~     the Quality Adjusted Life Year (QALY). If in economic evaluation the outcomes are expressed~     in QALYs gained, it is possible to compare the efficiency of different interventions for~     different indications. However, limited evidence on utility scores after treatment for HNC is~     available.~      Objective: The investigators' main objective is to examine quality of life (QoL), both~     utility scores and disease specific quality of life, for different treatment modalities in~     HNC. Secondary objectives are to examine whether QoL differs across health states, and which~     factors influence QoL. As extensive data are available on disease-specific quality of life,~     another objective is to examine whether utility scores can be derived from a commonly used~     disease-specific questionnaire, the EORTC QLQ-C30/QLQ-H&N35. If this would be possible, this~     would limit patient burden in future clinical trials. Finally, by means of measuring~     patients' ability to perform their work, diet and dental consequences the investigators aim~     to measure the impact of HNC and its treatment.~      Study design: The investigators' study design is a cross-sectional survey.~      Study population: The study population consists of patients with HNC who are treated at least~     six months ago for curative radiotherapy and/or surgery with or without chemotherapy.~      Intervention/method: Patients are asked to fill out a single set of questionnaires~     (once-only). The set of questionnaires consists of three validated questionnaires, concerning~     health state utility (EuroQol-5D), disease-specific quality of life (EORTC QLQ-C30/QLQ-H&N35)~     and productivity losses (PRODISQ). In addition, two questions inquiring about patients' diet~     and three questions considering the dental status of these patients are added to the~     questionnaires. To classify patients into certain health states, physicians are asked to~     score adverse events in patients during follow-up visits (according to the RTOG~     classification).~      Main study parameters/endpoints: The main study parameter is QoL (both disease specific~     quality of life and utility scores) in a certain health state. These utility scores can be~     used in future cost-effectiveness studies to identify the best available treatment option.~     Other important study parameters are the factors influencing QoL, and the relationship~     between utility score and disease-specific quality of life.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: As the study involves a once only set of questionnaires, the burden is only~     minimal. No risks are expected to be associated with participation. It is important to gain~     insight into QoL, patients' ability to perform their work, diet and dental consequences in~     long-term follow-up of HNC patients, to allow for evidence-based decision-making regarding~     treatment options for HNC.~   "
198589|NCT00963573|"~     This study attempts to document the therapeutic value of combining loratadine antihistamine~     action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may~     facilitate treatment adherence by patients whereas providing an effective and rapid perennial~     allergic rhinitis (PAR) symptoms relief.~   "
198590|NCT00963560|"~     The purpose of this study is to prospectively evaluate postoperative visual and refractive~     parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting~     Intraocular Lenses (IOLs).~   "
198591|NCT00963547|"~     This study will find the maximum tolerated dose of MK2206 in combination with both~     trastuzumab and trastuzumab/lapatinib in patients with HER2+ breast cancer and other solid~     tumors.~   "
198592|NCT00963534|"~     In phase I: Establishing maximally tolerated dose of lenalidomide in combination with~     bendamustine and rituximab.~      In phase II: Evaluation of progression free survival with treatment with lenalidomide,~     bendamustine and rituximab~   "
198593|NCT00963521|"~     RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune~     response to kill cancer cells.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how~     well it works in treating patients with acute myeloid leukemia in complete remission.~   "
198594|NCT00963508|"~     In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for~     head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an~     established head lice treatment. The new formulation has been evaluated in 2 previous studies~     of patients 2 years of age and older.~   "
198595|NCT00963495|"~     This is an open-label, single arm phase 1 study to evaluate the dose-limiting toxicity,~     maximum tolerated dose, and recommended phase II dose of Clioquinol in patients with relapsed~     or refractory hematologic malignancies. The study will also characterize Cliquinol's safety,~     tolerability and pharmacodynamic effect.~   "
198596|NCT00963482|"~     Most alcohol-dependent individuals are heavy smokers. The aim of this study is to evaluate~     whether a specific smoking cessation program (based on cognitive-behavioral therapy) for~     inpatient alcohol-dependent smokers is more effective than a control condition (treatment as~     usual).~   "
198598|NCT00963443|"~     The purpose of the study is to determine the effectiveness of an acetylsalicylic acid~     (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms~     compared to the effectiveness of the individual components of the medicine and the placebo~     (dummy treatment that looks like the real thing).The combination product of acetylsalicylic~     acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.~   "
198599|NCT00963430|"~     The purpose of this study is to evaluate an investigational 2009 H1N1 influenza vaccine to~     determine vaccine safety in pregnant women and the body's immune response (body's defense~     against disease) to different strengths of the H1N1 influenza vaccine. In this study, 2~     strengths of the H1N1 influenza vaccine will be tested (given 3 weeks apart). Participants~     will include approximately 120 healthy pregnant women, ages 18-39 years, in their second or~     third trimester of pregnancy (14-34 weeks gestation). Study procedures will include 2 doses~     of vaccine, blood samples, cord blood samples at delivery, and recording temperature and~     vaccine side effects in a memory aid for 8 days following each vaccination. Participants will~     be involved in study related procedures for about 7 months.~   "
198600|NCT00963417|"~     RATIONALE: Gathering information over time from bone density and laboratory tests of women~     with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of~     breast cancer in the future.~      PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast~     cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).~   "
198601|NCT00963404|"~     The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The~     bladder cancer patients included in the study will undergo tumor demarcation. The bladder~     demarcations will then be the target for an image-guided boost delivered precisely to the~     expected tumor site.~   "
198602|NCT00963391|"~     The purpose of this study is to conduct a Randomized Control Trial (RCT) in a developing~     country setting in order to evaluate the role of alcohol based hand sanitizers (ABHS) in~     preventing the transmission of infectious diseases in areas where water is a scarce resource.~     The investigators want to find out if the use of ABHS reduces the incidence of two leading~     causes of morbidity and mortality in children under 5 years of age in the developing world:~     acute diarrheal disease (ADD) and acute respiratory infections (ARI).~   "
198603|NCT00963365|"~     The purpose of this study is to determine the safety of AZD6765 when given in single and~     multiple oral doses and to compare an oral and intravenous (IV) formulation of AZD6765 to~     placebo.~   "
198604|NCT00963352|"~     1. Radical surgery. It is supposed to improve prognosis of colon cancer. A surrogate~          measure of achievement of radical surgery is the number of lymph nodes removed with the~          specimen.~        2. Markers. There may be variables that may make patient assessment more sound. The project~          is including investigation of such markers (genes, old age, comorbidity, and others).~        3. Laparoscopic resections. This is being used more and more in cancer surgery but the~          feasibility of this approach remains to be proven compared with conventional open~          surgery. The project compares these according to 1) and 2).~        4. Morbidity and mortality must be surveilled to keep at a minimum. Many patients have~          comorbidity and are old to make this factor extra important, including perioperative~          care.~        5. Proper treatment of colon metastases may prolong life. Treatment of lung-metastases will~          be studied in particular.~   "
198605|NCT00963339|"~     The purpose of this study is to evaluate the usability of the Foresee Home device with~     intermediate AMD patients.~   "
198606|NCT00963326|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is looking at blood and tissue samples from patients with larynx~     cancer, pharynx cancer, or oral cavity cancer.~   "
198607|NCT00963313|"~     Based on published data and according to the approved product label for ankylosing~     spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days~     should be effective in psoriatic arthritic patients with axial involvement.~   "
198608|NCT00963300|"~     RATIONALE: Diagnostic procedures, such as MRI, may help measure oxygen levels in tumor cells.~     It may also help doctors predict a patient's response to treatment and help plan the best~     treatment.~      PURPOSE: This clinical trial is studying how well MRI works in assessing hypoxia in patients~     with localized prostate cancer undergoing stereotactic body radiation therapy.~   "
198609|NCT00963287|"~     The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription~     on Ulcerative Colitis.~   "
198610|NCT00963274|"~     This phase I trial studies the side effects and best dose of giving bortezomib and romidepsin~     together in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic~     lymphoma (SLL), indolent B-cell lymphoma, peripheral T-cell lymphoma (PTCL) or cutaneous~     T-cell lymphoma (CTCL). Bortezomib and romidepsin may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth.~   "
198611|NCT00963261|"~     The purpose of this study is to analyse the physical and psychological side-effects in the~     course of treatment with IFN-alpha. The effectiveness of a specific intervention for the~     management of these side-effects is evaluated.~   "
198612|NCT00963248|"~     Question:~      In which stage of an EBV-infection is a selective reduction of immunosuppressive medication~     reasonable to minimize the risk for PTLD, without putting the transplant recipient at risk of~     acute rejection episodes due to under immunosuppression?~      Aim of study:~      Identification of patients at high-risk for PTLD.~   "
198613|NCT00963235|"~     The study will evaluate the safety, tolerability and immunogenicity of a 13-valent~     pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who~     have been previously immunized with at least one dose of 23-valent pneumococcal~     polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study~     vaccine dose given approximately 6 months apart.~   "
198614|NCT00963222|"~     The aim of this study is the comparison between the effects of supplementation with 25000 IU~     preformed vitamin A (retinyl palmitate) or placebo for 3 months on immune system and Th1/Th2~     balance in patients with and without atherosclerosis (documented with angiography).~   "
198615|NCT00963209|"~     RATIONALE: Estrogen can promote growth of endocrine sensitive breast cancer cells. Endocrine~     therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the~     tumor cells. Pharmacokinetics and -genomics can have an impact on the efficacy of the~     treatment.~      PURPOSE: This phase III trial is studying blood samples to see if the level of active~     metabolites of tamoxifen can be improved in patients with breast cancer.~   "
198616|NCT00963196|"~     This study will be a randomized controlled trial set in an outpatient clinic, involving~     patients with major depressive disorder, who will be treated with antidepressant therapy,~     which will be individually agreed upon by the subject and his or her physician. Patients will~     be randomized to receive either placebo or fish oil capsules containing eicosapentaenoic acid~     (EHA) and docosahexaenoic acid (DHA) in addition to their antidepressant medication. Subjects~     will complete a brief dietary and exercise habits survey at the beginning of the trial to~     take into account lifestyle factors that may be significant in symptom resolution. Their~     progress will be monitored over a period of twelve weeks, with standardized rating scales~     completed by subjects and treating physicians. At the end of the study, scores will be~     compared between groups to look for differences in timing and degree of symptom improvement~     to analyze whether improvement occurred faster in the group receiving essential fatty acids~     (EFAs) than in the one receiving placebo. The primary hypothesis is that supplementation of~     antidepressant therapy with omega-3 fatty acids will decrease the lag period between the~     start of therapy and the time of clinically significant symptom improvement. A secondary~     hypothesis is that the results of this study will be consistent with numerous previous~     studies showing improvement in symptom control in major depressive disorder when~     antidepressants are supplemented with omega-3 fatty acids.~   "
198617|NCT00963183|"~     The aim of the study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male~     subjects.~   "
198618|NCT00963157|"~     The purpose of this study is to see how the body reacts to different strengths of the H1N1~     flu shot when it is given with or without an adjuvant. An adjuvant is a substance that may~     cause the body to produce more antibodies when it is given with a vaccine. This study will~     also compare how age affects the body's response to the H1N1 flu shot. In this study, 3~     strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2~     strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the~     same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will~     include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250~     individuals greater than or equal to age 65. Study procedures include: physical exam, blood~     samples, completing a memory aid to record vaccine side effects, medications and daily oral~     temperature. Participants will be involved in study related procedures for up to 13 months.~   "
198619|NCT00963144|"~     The purpose of the study is to determine the applicability and utility of Gerd Q in the~     diagnosis of GERD and in the assessment of treatment response.~   "
198620|NCT00963131|"~     Central serous chorioretinopathy (CSC) is the serous neurosensory detachment that usually~     involves the macular area. It is common in patients between 30-50 years old and effects male~     more often than female with the ratio of 5-10. The common risk factors are psychologic~     stress, type A personality, systemic steroid use, hypertension and pregnancy. The treatment~     is usually observation especially in the first three-months. The laser or photodynamic~     therapy should be considered when the condition does not improve after that time.~     Nevertheless, the pathogenesis of CSC is still not well understood but the study from~     indocyanine green angiography showed the choroidal vascular hyperpermeability and abnormal~     leakage. The causes of this abnormality are supposed to be from nitric oxide, prostaglandins~     or even free oxidative radicals. From this hypothesis, the oxidative process might be~     involved in the pathogenesis of the disease especially in the early stage. This study is to~     determine the effect of antioxidants drugs in the acute stage of CSC and to determine whether~     they can improve the outcomes of the disease.~   "
198621|NCT00963118|"~     To achieve optimal health and to reduce the risk of age-related chronic diseases through an~     easily achievable dietary modification not achievable by the limited mixture of antioxidant~     supplements in older subjects, the investigators will focus their attention on the biological~     functions of bioactive plant food (Angelica keiskei and/or Glycine max) and its effect on~     genomic stability using noble assays.~      The investigators propose to study the ability of bioactive plant-based food (Nutrition bar~     made from Angelica keiskei and/or Glycine max) to 1) exert biological functions: increase~     total antioxidant performance, decrease oxidative stress in vivo, and 2) affect genomic~     stability: decrease DNA damage and modify DNA methylation. The investigators hypothesize that~     bioactive plant food (green leafy vegetable power, and/or black bean power) will exert~     biological functions and affect genomic stability far more efficiently than the limited~     mixture of purified antioxidant supplements in the vulnerable population, older subjects (>~     50 years, men and postmenopausal women) with and without metabolic syndrome.~   "
198622|NCT00963105|"~     The purpose of this study is to determine the safety and effectiveness of different dose~     regimen of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia.~   "
198623|NCT00963092|"~     RATIONALE: Collecting and storing samples of tissue, blood, and saliva from patients with~     cancer to test in the laboratory may help the study of cancer in the future.~      PURPOSE: This research study is collecting blood and tissue samples from patients with~     stomach cancer, esophageal cancer, or gastroesophageal junction cancer, studying them in the~     laboratory, and storing them for future studies.~   "
198624|NCT00963079|"~     This study tests the hypothesis that controlled ovarian stimulation impairs endometrial~     receptivity in high responders.~   "
198625|NCT00963066|"~     Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist NAVA in patients~     who recover spontaneous breathing after acute lung injury.~   "
198626|NCT00963053|"~     The purpose of the study is to investigate how effective VA111913 is at preventing menstrual~     pain in women with primary dysmenorrhoea.~   "
198696|NCT00962117|"~     The purpose of the study is to determine whether the presentation of various foods produces~     an increase or decrease in responses on a motivational computer task. In addition, the study~     determines if energy intake or motivation to obtain food is related to the dopamine receptor~     genotype.~   "
198627|NCT00963040|"~     The objective of this prospective, randomized, double-blind, parallel-group,~     placebo-controlled study is to determine the effectiveness of intranasal oxytocin in subjects~     suffering from chronic daily headache. The primary outcome measure is the reduction in~     headache intensity after drug administration; secondary outcome measures are the headache~     symptoms, nausea, vomiting, photophobia, and phonophobia. Additional secondary outcome~     measures are intake of rescue medication and patient satisfaction over a period of 24 hours.~   "
198628|NCT00963027|"~     The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor,~     on treprostinil pharmacokinetics.~   "
198629|NCT00963001|"~     The purpose of this study is to assess the pharmacokinetic and safety profile of a single~     dose of oral treprostinil following four different meals of varying caloric and fat content.~   "
198630|NCT00962988|"~     Research Aims~      The aims of this research study are to determine whether cost-free smoking cessation~     pharmacotherapy:~        1. Helps smokers with Transient Ischemic Attack (TIA) or stroke to quit smoking over the~          long-term, compared to simply providing a prescription for these medications;~        2. Is a more cost-effective alternative to providing a prescription only for these~          medications in this high risk population.~      Hypotheses to be Tested~      The hypotheses to be tested include the following:~        1. The CO-validated continuous abstinence rate at weeks 26 and 52 following a target quit~          date will be at least 10% higher for the cost-free smoking cessation pharmacotherapy~          intervention group compared to the prescription only usual care group;~        2. Cost-free smoking cessation pharmacotherapy will have a greater cost-effectiveness~          (i.e., cost/quit) than providing a prescription only.~   "
198631|NCT00962975|"~     In this open-label multicenter study the long-term effect of Pegasys monotherapy on~     pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis~     B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512)~     and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once~     weekly) for up to 48 weeks. Target sample size is <100.~   "
198632|NCT00962962|"~     The purpose of the study is to evaluate the effects of different amounts and intensities of~     aerobic exercise training programs, with and without weight loss, in people who are at risk~     for diabetes. An additional purpose of the study is to evaluate the factors in the blood and~     in exercising muscles that contribute to the improvement in those risk factors. This~     information will be used to improve exercise training guidelines for improving cardiovascular~     and metabolic health in people with abnormal fasting glucose, also known as prediabetes.~   "
198633|NCT00962949|"~     The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in~     the pathophysiology of postural tachycardia syndrome, and to provide an insight about the~     disease process in this disorder.~   "
198634|NCT00962936|"~     This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe~     to give and if it helps patients with hepatitis C virus (HCV). Monoclonal antibodies are a~     type of drug that is typically given by infusion into a vein (intravenously). Results of this~     trial will help doctors obtain additional information with regard to the safety and efficacy~     of CT-011 as a potential treatment for HCV.~   "
198635|NCT00962923|"~     This study will explore safety and efficacy of allogeneic mesenchymal stem cells~     transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have~     been resistant to multiple standard treatments. The underlying hypothesis is that the SSc~     condition is caused by an abnormal immune homeostasis that can be restored by MSCT.~   "
198636|NCT00962910|"~     Care pathways, a complex intervention to (re)organise, standardize and evaluate care~     processes, are used worldwide and in different kinds of settings. Although their~     international use, the impact is unclear. The European Quality of Care Pathways Study is the~     first international cluster Randomized Controlled Trial on the effect of care pathways for~     proximal femur fracture patients (PFF).~      The hypothesis is that teams who work with care pathways for PFF patients deliver care that~     is more compliant to evidence based key interventions, have better patient outcomes and~     higher scores on team indicators than teams who do not work with care pathways.~   "
198637|NCT00962897|"~     A retrospective review with four year followup on patients that had previously been enrolled~     in a study to evaluate blockages in the lower legs. The study looked at patients that had~     undergone a bypass of the leg from the groin to the knee area with an incision in each area~     using general anesthesia. These patients were compared to others who had undergone treatment~     with balloon dilatation and stents in the arteries in the thighs with only numbing medicine.~     The study was completed two years ago and was initially designed to look at outcomes at 24~     months. Now the investigators are trying to go back and look at outcomes of these patients'~     treatment at 4 years by simply reviewing their records.~   "
198638|NCT00962884|"~     The investigators will test whether breathing through an inspiratory resistance device will~     improve the ability to be upright and decrease blood pressure drops on standing in patients~     with orthostatic hypotension.~   "
198639|NCT00962871|"~     This open-label, randomized, parallel-arm study will assess the early immunologic response in~     treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment~     with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4~     cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally~     daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may~     opt to receive standard of care treatment with Pegasys. Target sample size is <50.~   "
198640|NCT00962845|"~     RATIONALE: Studying samples of blood, tumor tissue, and skin in the laboratory from patients~     with melanoma receiving hydroxychloroquine may help doctors understand the effect of~     hydroxychloroquine on biomarkers.~      PURPOSE: This early phase I trial is studying hydroxychloroquine in patients with stage III~     or stage IV melanoma that can be removed by surgery.~   "
198641|NCT00962832|"~     This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to~     evaluate the efficacy and safety of rontalizumab compared with placebo in patients with~     moderately to severely active systemic lupus erythematosus (SLE).~   "
198697|NCT00962104|"~     The purpose of this study is to assess the efficacy, the quality of life, and the safety of~     multiple dosing atomoxetine in Asian adult subjects with attention deficit/hyperactivity~     disorder (ADHD).~   "
198642|NCT00962819|"~     This study will lay the foundation for determining the underlying reasons for lack of~     immunity to mumps that led to the 2006 mumps outbreak on college campuses in the Mid West,~     and it will assess the potential for similar outbreaks of measles and rubella. A total of 70~     to 80 college students (age 18 to 22) on the Emory campus (or nearby college campuses or the~     community) will be assessed for antibodies to measles, mumps or rubella by drawing a one-time~     blood sample. Their medical records will be verified for documentation of immunization with~     MMR vaccine prior to enrollment in the study. If a study volunteer is found to not have MMR~     immunity, they will be offered an MMR-II vaccine. For this group, additional blood specimens~     will be obtained.~   "
198643|NCT00962806|"~     Obesity and type 2 diabetes are occurring at epidemic rates in the United States and~     worldwide. The global burden of diabetes is estimated to double over the next 25 years. Obese~     children are at risk for the development of insulin resistance, relative insulin deficiency~     and type 2 diabetes mellitus (DM). The prevention of type 2 DM is hindered by the lack of a~     non-invasive predictive test, knowledge as to individual risk and effective preventative~     measures. There is increasing evidence that alterations in mitochondria contribute to the~     development of diabetes in humans. Therefore, it is important to explore mitochondrial~     dysfunction as a potential predictor of diabetes in children and a potential target for~     prevention. The aims of the proposed protocol are to determine whether an intensive exercise~     intervention can improve mitochondrial function in children identified as having~     mitochondrial dysfunction and insulin resistance. The use of a non-invasive imaging technique~     will allow for a functional in vivo assessment of mitochondrial activity. The investigators~     propose the investigation of an intensive exercise protocol designed to improve mitochondrial~     function in children who are insulin resistant and have documented mitochondrial dysfunction~     by magnetic resonance spectroscopy. The study is designed to investigate the plasticity of~     abnormal mitochondrial function in high risk children. In summary, the proposed projects will~     investigate mitochondrial function as a non-invasive predictive marker for the development of~     insulin resistance and type 2 diabetes mellitus in children and attempt to modify~     mitochondrial function with an intensive exercise intervention. The study of mitochondrial~     dysfunction in children may both identify those at risk for disease and provide a molecular~     therapeutic target for prevention and treatment.~      The investigators hypothesize that children with insulin resistance and mitochondrial~     dysfunction who are randomized to intensive exercise versus standard lifestyle advice will~     show improvement in mitochondrial function and insulin sensitivity.~   "
198644|NCT00962793|"~     The investigators think that the health care workers who contact frequently with active~     tuberculosis patients have more increased prevalence of LTBI compared with those who don't.~   "
198645|NCT00962780|"~     The study will evaluate the safety, tolerability and immunogenicity of a 13-valent~     pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who~     have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3~     doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with~     each dose given approximately 1 month apart.~   "
198646|NCT00962767|"~     The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL~     patients in achieving first hematological complete remission and molecular remission.~   "
198647|NCT00962754|"~     The purpose of this study is to determine if routinely recording fluid balance in sick~     neonates admitted to the pediatric ward is reliable and useful. The investigators' hypothesis~     is that it is not useful and reliable.~   "
198648|NCT00962741|"~     This study will evaluate the effect of etanercept on the clinical benefit, safety, and~     physical functioning (ability to function in daily life) in children and adolescent subjects~     with 3 subtypes of childhood arthritis.~   "
198649|NCT00962728|"~     The investigators will test whether breathing through an inspiratory resistance device will~     improve the ability to be upright and decrease heart rate increases on standing in patients~     with postural tachycardia syndrome.~   "
198650|NCT00962715|"~     The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon~     (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in~     increasing the body's immune reaction against the flu virus in patients with Chronic~     Lymphocytic Leukemia (CLL).~   "
198651|NCT00962702|"~     The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include~     the rate of device related adverse and serious adverse events and the extent of complete~     exclusion of the LAA with minimal residual cavity.~   "
198652|NCT00962689|"~     Chronic rhinosinusitis (CRS) is the most common chronic medical condition that affects~     Americans between 18-44 years of age. While significant advances have been made in the~     understanding of the molecular pathogenesis underlying many subtypes of CRS, this has not~     translated into widespread changes in how physicians manage adult or pediatric CRS. The focus~     of this study is intended to develop testing methods to improve the objectivity and~     specificity of diagnosis and allow for individualized therapy with less invasive, customized~     treatments instead of the traditional, empiric based, and radically exenterative therapies~     commonly employed in clinical practice. Specifically, it is now known that many patients with~     CRS have a greater concentration of non-typeable Haemophilus influenzae (NTHI) in the~     bacterial biofilms located within their sinus cavities compared to healthy patients. The~     specific hypothesis behind the proposed research is that the presence of NTHI biofilms, which~     are known to be highly recalcitrant, are positively correlated with the development of CRS~     and that unique lipooligosaccharides and inflammatory byproducts obtained from nasopharyngeal~     lavage fluids and/or swabs of sinus secretions may be used as a non-invasive biomarker for~     CRS. As a result, patients with symptoms of CRS specifically associated with NTHI biofilms~     could possibly obtain a non-invasive test in the physician's office that would allow the~     clinician to make a more accurate diagnosis and objectively follow each patient's~     responsiveness to customized therapy.~   "
198653|NCT00962676|"~     For diagnosis of active tuberculosis, interferon-γ release assay based mycobacterium~     tuberculosis specific antigen may show higher sensitivity than tuberculin skin test in~     immunocompromised patients. Therefore, interferon-γ release assay have a role as a rapid~     diagnostic adjunctive methods for active tuberculosis in immunocompromised patients.~   "
198654|NCT00962663|"~     The purpose of this study is; to determine the pharmacodynamic (PD) effects of ICA-105665~     using the intradermal (ID) capsaicin model in healthy male subjects, and to investigate the~     effect of ICA-105665 on inflammatory hyperalgesia using the ultraviolet B (UV-B) model in~     healthy male subjects.~   "
198655|NCT00962650|"~     The study will document being able to successfully perform transgastric diagnostic~     peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.~   "
198698|NCT00962091|"~     This is an open-label, multicenter, phase 1 study to evaluate the safety and pharmacokinetic~     properties of an oral solution and enteric-coated tablet (ECT) formulations of MLN8237 in~     patients with advanced solid tumors. This study will be conducted in 3 parts, A, B, and C.~   "
198656|NCT00962637|"~     Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene~     (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum~     testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1~     of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit.~     Subjects took their medications orally or by rubbing it onto the skin (depending on the~     treatment assignment) once daily for up to 6 months. Treatment visits occurred at~     approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months~     4, 5, and 6.~   "
198657|NCT00962624|"~     The study involves the measurement of immune response to vaccination with three doses of a~     meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in~     healthy adults (Laboratory workers). The study will be completed at the Manchester Medical~     Microbiology Partnership in the UK and will enrol staff who may be at potential occupational~     exposure to meningococci. Blood samples will be taken before and after each vaccination and~     used to determine if the vaccines induce protective responses.~   "
198658|NCT00962611|"~     The purpose of this study is to determine the tolerability, maximum tolerated dose and~     pharmacokinetics of this drug.~   "
198659|NCT00962598|"~     The purpose of this study is to examine the effects of a 10-week Omega-3 Fatty Acid treatment~     phase on brain chemistry of adolescents with major depressive disorder (MDD) using proton~     magnetic resonance imaging.~   "
198660|NCT00962585|"~     The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal~     patients with hot flushes and night sweats.~   "
198661|NCT00962572|"~     A study to see if coordinated aggressive patient management will improve patient treatment~     outcomes and is cost effective.~   "
198662|NCT00962559|"~     Introduction:~      Almost 50% of patients die after aneurismal subarachnoid hemorrhage (aSAH). 30% of the~     survivors suffer from neurological handicap and need permanent care (Suarez et al.). Even~     when neurological outcome is good, neuropsychological deficits are frequently observed (Ogden~     et al., Anderson et al.) The incidence rate of aSAH is almost 8 of 100.000 per year. Due to~     similar clinical symptoms to patients with hypopituitarism, several studies have analyzed the~     incidence of hypopituitarism after aSAH. Dysfunction of the anterior pituitary gland was~     found in up to 47% (Schneider et al.). GH deficiency was demonstrated in almost every fourth~     patient and an association with poor recovery was postulated. In Germany, the investigators~     would therefore expect as many as 1200 patients with incident GH deficiency. The KIMS-study~     is an observational GH-treatment study in adult onset growth hormone deficiency. Within the~     epidemiological data of KIMS, aSAH is not known as a relevant contributing cause (Brabant et~     al.). This resembles much of the investigators clinical experience that there is no huge~     prevalence of hypopituitarism after aSAH.~      Objective: Evaluation of the frequency of hypopituitarism and neuropsychological dysfunction~     of any degree in patients with aSAH in a prospective approach.~      Methods:~      The investigators conduct a prospective study for the evaluation of endocrine deficiency with~     aSAH. The investigators study patients 3, 6 and 12 month after aneurismal bleeding. Patients~     diagnosed with aSAH with a clinical grade of I-IV according to Hunt and Hess are included in~     the study. The investigators perform basal testing for the pituitary by measuring: TSH, LH,~     FSH, IGF-1, GH, prolactin and ACTH. For evaluation of the adrenal function the investigators~     perform an ACTH-stimulation test (Lindholm et al.). Subjects with evidence for adrenal or GH~     insufficiency are further analyzed by insulin-induced hypoglycemia testing (GH Research~     Society). In the neuropsychological examination, the investigators screen for verbal~     comprehension (Token Test, short form) and visual neglect (line bisection). Verbal and visual~     short term memory (digit and spatial span), visuospatial construction and figural memory (Rey~     Osterrieth Complex Figure Test), psychomotor speed, attention and concentration (Trail Making~     Test Part A and B, d2) as well as mental flexibility (word fluency) are assessed. Patients~     additionally fill out a questionnaire measuring actual depressive symptoms and anxiety~     (Hospital Anxiety and Depression Scale).~   "
198663|NCT00962546|"~     Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage after cerebral~     aneurysm rupture leading to cerebral ischemia and potentially cerebral infarction. The~     current gold standard diagnostic imaging study for cerebral vasospasm is catheter cerebral~     angiography, an invasive diagnostic procedure carrying a complication rate of 1-2% per~     procedure. Computed tomographic perfusion imaging (CTP) and computed tomographic angiography~     (CTA) are noninvasive diagnostic imaging studies frequently utilized in the evaluation of~     embolic and thrombotic cerebral infarct. The investigators hypothesize that CTP and CTA may~     be utilized as screening tools for cerebral vasospasm following aneurysmal subarachnoid~     hemorrhage requiring treatment and provide prognostic information.~   "
198664|NCT00962533|"~     The purpose of this trial is to prove that the strategy of treatment adjustment at W24~     according to virological response based on ROADMAP concept is better than standard of care~     strategy.~   "
198665|NCT00962520|"~     This study is a phase II trial of erlotinib in combination with chemoradiation in patients~     with resected stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant~     chemoradiation. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus~     Capecitabine 800 mg/m2 by mouth twice daily (PO BID) (5 days on/2 days off regimen) and~     External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after~     pancreatectomy (dosing for capecitabine and erlotinib was amended after considering the~     toxicity profile of the first 6 patients). Approximately 4-8 weeks after the conclusion of~     chemoradiation, it is recommended patients will continue treatment with 4 cycles of~     gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.~   "
198666|NCT00962507|"~     RATIONALE: Panobinostat and everolimus may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving~     panobinostat together with everolimus may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when~     given together with everolimus in treating patients with relapsed or refractory lymphoma or~     multiple myeloma.~   "
198667|NCT00962494|"~     Cancer: Surviving and Thriving is a 6-week workshop for cancer survivors. The overall goal of~     the study is to determine whether an online cancer survivor education and support workshop~     can have lasting beneficial effects in helping survivors improve their self-management of~     health skills and quality of life.~   "
198668|NCT00962481|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of repeated~     inhalative doses of Bimosiamose on ozone induced sputum neutrophilia in healthy subjects.~   "
198669|NCT00962468|"~     Care pathways, a complex intervention to (re)organise, standardize and evaluate care~     processes, are used worldwide and in different kinds of settings. Although their~     international use, the impact is unclear. The European Quality of Care Pathways Study is the~     first international cluster Randomized Controlled Trial on the effect of care pathways for~     COPD patients.~      The hypothesis is that teams who work with care pathways for COPD patients deliver care that~     is more compliant to evidence based key interventions, have better patient outcomes and~     higher scores on team indicators than teams who do not work with care pathways.~   "
198670|NCT00962455|"~     Spirometry is a biomedical test to measure lung function in subject who (may) have a chronic~     respiratory condition. Performing the test requires a certain level of training and~     experience from the health care professional who conducts the test, and sufficient~     cooperation of the patient. Although the test is widely used in primary care in many~     countries, the quality of the test performance seems limited and needs improvement in order~     to avoid false-positive and false-negative test interpretations. In this study, the~     researchers investigated whether a combination of e-learning and bimonthly written~     performance feedback to family practice nurses and assistance regarding their spirometry~     tests improves the rate of adequate tests.~   "
198671|NCT00962442|"~     Acute alcoholic hepatitis (AAH) is the most severe form of alcoholic liver disease (ALD) and~     is associated with a high risk of dying in the short term. Corticosteroids are generally~     recommended in patients with severe AAH, but its use is still controverted and~     contraindicated in case of active infection or gastrointestinal bleeding. Therefore,~     alternative therapeutic options are needed.Ethanol consumption results in the depletion of~     endogenous antioxidant capabilities and patients with ALD have evidence of antioxidant~     deficiencies.Due to its effects on glutathion stores restoration and as such the limitation~     of the oxidative stress and its good tolerance and safety profile, N-acetylcysteine (NAC) is~     an attractive agent for the treatment of AAH.In this context, we hypothesized that NAC might~     be beneficial in severe AAH.~   "
198672|NCT00962429|"~     The purpose of the study is to examine if alpha lipoic acid is an effective treatment for~     chronic inflammatory demyelinating polyneuropathy (CIDP).~   "
198673|NCT00962416|"~     Stent study:~      Treatment of patients with acute myocardial infarction with drug eluting stents (DES) is~     effective but there remain concerns regarding the long-term safety and adverse effects on the~     adjacent arterial wall. The biolimus-eluting Biomatrix stent addresses the issues by~     incorporating modifications as a biodegradable polymer and a drug application solely to the~     abluminal stent surface. While clinical data about the biolimus-eluting stent show a~     favorable safety and efficacy profile, they require confirmation in a dedicated randomised~     trial in the subset of patients with STEMI. Therefore, the study is designed to compare the~     safety and efficacy of biolimus-eluting Biomatrix stent as compared to a bare metal stent of~     otherwise identical design in a prospective, multicenter, randomized, controlled superiority~     trial in patients with acute ST-elevation myocardial infarction.~      Stent and Plaque Imaging Substudy:~      In a substudy of the above mentioned stent trial, the investigators will perform a~     prospective, multicenter, longitudinal cohort study of 100 consecutive STEMI patients~     undergoing urgent coronary angiography and will employ high-resolution Optical Coherence~     Tomography (OCT) imaging technology and intra-vascular ultrasound and virtual histology~     (IVUS-VH) of the culprit STEMI lesions pre- and postprocedural as well as at a 13 months~     follow up. Assessment of vascular wall responses, including volumetric measurements of~     vessel, stent, lumen, peri-stent plaque, and intimal hyperplasia, indices of remodeling,~     stent expansion, and stent-vessel wall apposition in response to biolimus-eluting and~     bare-metal stent implantation will be performed. Moreover, IVUS, IVUS-VH and OCT will be~     performed in all three epicardial vessels in order to quantify and map the number, frequency~     and distribution of ruptured plaques at baseline and follow-up and quantify the morphological~     changes of ruptured and vulnerable plaques at baseline and follow-up and quantify the~     morphological changes over time in response to standard medical treatment. Therefore, new~     insight regarding the frequency, distribution, composition and evolution of coronary artery~     plaques and their prognostic impact on patients clinical outcome can be expected from the~     present study. Since patients suffer from a recurrent ischemic event rate of 5-10% during the~     first year, these findings may have important therapeutic implications for the medical~     treatment of affected patients to further reduce the risk of recurrence and improve~     prognosis.~   "
198674|NCT00962403|"~     The main objective of this preliminary randomized controlled clinical trial is to establish~     efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared~     to a delayed yoga treatment (waitlist control) group. Secondary objectives are to evaluate~     PTSD characteristics that may also be improved with the treatment and acceptability and~     compliance with the treatment.~   "
198675|NCT00962390|"~     The purpose of this study is to assess the safety and effectiveness of S-equol in men with~     benign prostatic hyperplasia.~   "
198676|NCT00962377|"~     This study is designed to evaluate the safety and efficacy of a peripheral blood mononuclear~     cell gene expression profiling method (AlloMap) in monitoring asymptomatic heart transplant~     patients for acute rejection beginning 2-6 months(≥ 55-185 days) after transplantation.~   "
198677|NCT00962364|"~     This study will provide follow-up information and care of patients who have undergone~     autologous intracoronary bone marrow cell administration at our institution. Patients are~     monitored for their response to treatment, progression of heart failure and coronary artery~     disease, and potential later occurring effects of the administered bone marrow cells.~      Patients are eligible for this follow-up study if they have received their first~     intracoronary bone marrow cell administration for the treatment of cardiac disease at our~     institution from 2001 ongoing.~      Participants are generally seen in the clinic at 12 months and 5 years after cell~     administration, in the meantime regular yearly telephone contacts are performed until 10~     years after cell transplantation.~      The detailed description contains the planned procedures that are performed during the~     clinical visits and, if necessary, at additional contacts.~   "
198678|NCT00962351|"~     This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and~     titanium ion levels of a metal-on-metal articular bearing coupled with two different head~     sizes to that of a conventional metal-on-polyethylene bearing.~   "
198679|NCT00962338|"~     The investigators want to identify limiting factors for short convalescence after~     laparoscopic groin hernia repair. Before the operation patients are given intensive~     structured information about one day´s convalescence. Patients fill out questionnaire before~     operation about several clinically relevant parameters. This is also done first 3 days after~     operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and~     6 months.~   "
198680|NCT00962325|"~     For the growing number of severely obese individuals, there are currently few effective~     long-term weight control options with the exception of bariatric surgery. However, behavioral~     factors including low physical activity can undermine successful surgical outcomes. This~     study will compare the effects of a behavioral physical activity intervention with a standard~     care control condition on changes in physical activity among inactive adult bariatric surgery~     patients.~   "
198681|NCT00962312|"~     RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with~     capecitabine works in treating patients with metastatic pancreatic cancer.~   "
198683|NCT00962286|"~     Background: Obesity is associated with a high prevalence of chronic kidney disease. The~     glomerular hyperfiltration associated with obesity may play a role in the pathogenesis of~     obesity associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological~     means may slow down the development and progression of chronic renal failure. The~     investigators have previously shown that acetazolamide, a proximally acting diuretic that~     activates TGF by increasing solute delivery to the macula densa, abates glomerular~     hyperfiltration. The present study was designed to test the hypothesis that this decrease in~     hyperfiltration is specific to acetazolamide and not due to a non specific diuretic effect.~     The aim of the present study is to evaluate the effects of the administration of furosemide~     p.o. to subjects with severe obesity on glomerular hemodynamics.~      Methods: Ten obese subjects will participate in the study. They will undergo measurement of~     glomerular filtration rate (inulin clearance) (GFR), renal plasma flow (RPF) (p-aminohippuric~     acid clearance), filtration fraction, fractional excretion of lithium (FE LI) and blood~     pressure, before and after administration of oral furosemide 20 to 40 mg bid for 3 days. The~     effects of furosemide on glomerular hemodynamics in obese subjects will be compared to the~     previously studied effects of acetazolamide.~   "
198684|NCT00962273|"~     The purpose of this study is to determine the effects of an interactive, computerized~     learning resource designed to increase resilience in hospital-based health care workers~     preparing for an influenza pandemic. The effects of the learning resource will be compared to~     a non-interactive learning resource condition and a control condition. It is hypothesized~     that (a) online pandemic-related education reduces absenteeism and interpersonal problems for~     healthcare workers (HCWs), and improves their pandemic self-efficacy in the short and~     long-term, and (b) an interactive format for online education is necessary for its benefits.~   "
198685|NCT00962260|"~     This is an open-label expanded access trial of prGCD in patients with Gaucher disease who~     require enzyme replacement therapy (ERT) and who have been treated with imiglucerase but for~     whom the dose has been reduced or discontinued due to shortage of the product.~   "
198686|NCT00962247|"~     The primary aim is to examine how reduction in sedentary behaviors influences physical~     activity and energy intake.~   "
198687|NCT00962234|"~     The causes of failing nutrition status in advanced cancer are not well known. The way fat is~     moved, stored, burned or changed into other compounds may be affected and will be followed in~     patients using a tracer and other blood tests. The investigators hypothesize that fat loss~     and wasting results from low essential fatty acid availability in the body. Changes may occur~     in the liver that limits distribution and availability of fat to the body as an energy source~     or for other essential functions.~   "
198688|NCT00962221|"~     Overt hypothyroidism is associated with increased risk for cardiovascular disease (CVD) as~     indicated by hypertension, hypercholesterolemia, and increased low-density lipoprotein~     cholesterol (LDL-C) levels. Mild hypothyroidism, also called subclinical hypothyroidism [SH]~     is highly prevalent in elderly subjects, especially in women older than 50 years of age.~     Whether SH is related as a risk for premature CVD is controversial. It was shown that SH is~     associated with elevated lipids levels, particularly LDL-cholesterol. However recent evidence~     suggests that the 'quality' rather than only the 'quantity' of LDL-cholesterol exerts a~     direct influence on the cardiovascular risk. LDL-cholesterol comprises multiple distinct~     subclasses that differ in their atherogenic potential. Thus, the proposed study protocol is~     intended to evaluate the different LDL lipoproteins subclasses in patients with subclinical~     hypothyroidism.~   "
198689|NCT00962208|"~     The primary aim of this study is to evaluate and compare the eyeball elongation in children~     wearing orthokeratology lenses and single-vision spectacles.~   "
198690|NCT00962195|"~     Purple Sweet Potato juice (PSP-juice) is a juice based on purple-fleshed sweet potato~     concentrate, containing a high level of anthocyanins. Purple-fleshed sweet potatoes have~     attracted attention to industry and scientists due to multiple physiological functions such~     as radical-scavenging, ACE-inhibitory and α-glucosidase inhibitory activities in vitro, and~     also hepato-protective, antihypertensive and antihyperglycemic effects in vivo. Previous~     studies in Japanese subjects showed potential beneficial effects of PSP beverages on liver~     function and blood pressure in volunteers with impaired hepatic function and/or hypertension.~      The main objective of this study is to examine the effect of PSP-juice on liver enzymes and~     blood pressure. The secondary objective is to examine the effects of PSP-juice juice on~     insulin resistance.~   "
198691|NCT00962182|"~     The purpose of this study is to examine whether a cocktail of two common food-grade enzyme~     supplements leads to decrease of serum activity markers in celiac disease patients~     insufficiently treated by previous gluten exclusion.~   "
198692|NCT00962169|"~     The purpose of this study is 1) to develop an intervention strategy to increase~     physiotherapists' adherence to evidence-based practice guidelines, 2) to try out this~     intervention on a small scale to determine what efficacy may be expected from it, and 3) to~     determine the value of a planned, systematic and theory-based approach that was followed in~     developing and implementing the intervention.~   "
198693|NCT00962156|"~     -  By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation~          in critically ill.~        -  High molecular weight HES may, however, cause acute kidney failure in patients with~          severe sepsis.~        -  Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian~          intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.~        -  HES 130/0.4 is largely unstudied in ICU patients.~        -  This investigator-initiated Scandinavian multicentre trial will be conducted to assess~          the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with~          severe sepsis.~        -  The trial will provide important data to all clinicians who resuscitate septic patients.~   "
198694|NCT00962143|"~     The purpose of this study is to assess the clinical performance of the OrthADAPT Bioimplant~     in patients with acute mid-substance Achilles tendon tears requiring surgical repair.~   "
198695|NCT00962130|"~     The purpose of this study is to determine if 1) a continuous glucose monitoring system can~     measure glucose levels in transferred tissue during reconstructive surgery, and 2) if glucose~     measurements from a continuous glucose monitoring system correlate with tissue blood~     perfusion.~   "
198752|NCT00961350|"~     Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for~     developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.~   "
198699|NCT00962078|"~     The purpose of this study is to study the effects of a complex pulmonary rehabilitation~     program on mobility measured by 6 minute walking distance (6MWD) and physical activity,~     measured via Dynaport and Actibelt Aktivitätsmonitor, dyspnoea (VAS), quality of life (HRQL~     (SF36, EuroQul)), anxiety and depression (HADS)and PaCO2-behavior under physical activity.~   "
198700|NCT00962065|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211~     versus a placebo control in subjects with type 2 diabetes mellitus.~   "
198701|NCT00962052|"~     The investigators' long-term objective is to research and develop innovative new tests which~     diagnostic laboratories can use to 1) detect methylated DNA targets, 2) tumor specific~     antigens, and 3) markers of Bacillus Calmette-Guerin (BCG) treatment in patient urine~     samples. The investigators plan to detect methylated DNA targets and control targets by~     methylation-specific polymerase chain reaction (msPCR) on DNA isolated from urine samples~     from bladder cancer positive and negative patients to determine its sensitivity and~     specificity in detecting bladder cancer. The investigators plan to use patient sera as a tool~     to detect tumor specific antigens expressed by bladder cancer cell lines. Once a bladder~     tumor specific protein is identified, the investigators will assess its presence in the urine~     of bladder cancer patients and absence in healthy patients by enzyme-linked immunosorbent~     assay (ELISA). The investigators plan to use both in vitro models and patient clinical~     samples to elucidate the role of bladder epithelial cells in mediating BCG immunotherapy and~     identify biomarkers of treatment effectiveness. Once a biomarker is identified, the~     investigators will assess its presence in the urine of bladder cancer and absence in healthy~     patients.~      Once the investigators determine the feasibility of these tests, the investigators will~     further perform an extensive clinical study, comparing the tests to existing diagnostic~     methods. This study will provide the foundation for FDA approval, which is required for tests~     to become widely accepted tools for clinicians to use in bladder cancer diagnosis. The~     investigators' tests will improve early detection of bladder cancer, thereby improving~     patient health and decrease cancer deaths, a key mission of the National Institutes of~     Health.~   "
198702|NCT00962039|"~     This study aims to determine whether citalopram is a useful, well-tolerated, and safe~     treatment for children and adolescents ages 7 to 18 years with functional abdominal pain. The~     study hypothesis is that citalopram will be better than placebo in producing clinical~     improvement and reductions in abdominal pain. It is also hypothesized that citalopram and~     placebo will not differ in terms of safety and tolerability.~   "
198703|NCT00962026|"~     This study is being done to see if an investigational drug called rilonacept is safe to use~     in patients with type 1 diabetes, and if it can slow the loss of the body's ability to~     secrete insulin in patients who are still able to make a small amount of insulin.~   "
198704|NCT00962013|"~     The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.~   "
198705|NCT00962000|"~     The purpose of this study is to look at how the dose of dialysis is affected by the rate at~     which dialysate flows through the dialyzer. The dose of dialysis (Kt/V) will be determined by~     measuring blood levels of urea at the beginning and end of dialysis at two different~     dialysate flow rates.~   "
198706|NCT00961987|"~     The aim of this pilot project is to determine if there are differences in patient outcomes~     and healthcare utilization between patients randomly assigned to usual care (a collaborative~     model of maternity care with co-located healthcare professionals but with referrals to~     off-site obstetricians) or to a collaborative model of maternity care with co-located~     healthcare professionals, including obstetricians. It is hypothesized that by creating a~     seamless interface between obstetrical consultation and ongoing longitudinal maternity care,~     patient outcomes (birth outcome data), patient satisfaction and healthcare utilization,~     including number of outpatient visits, ultrasounds, laboratory tests, consultations, etc,~     will be improved in the intervention group compared with the group receiving usual care. The~     results could potentially lead to other sites adopting this innovative model of maternity~     healthcare delivery.~   "
198707|NCT00961974|"~     The purpose of this study was to determine the ability of a family-focused, office-based~     intervention to improve medical and behavioral outcomes for children and adolescents with~     type 1 diabetes.~   "
198708|NCT00961961|"~     The purpose of this study is to determine whether the long-term use of combined~     antidepressant plus mood stabilizer therapy is superior to mood stabilizer therapy alone in~     preventing the relapse and recurrence of bipolar depression.~   "
198709|NCT00961948|"~     A prospective, randomized trial to determine indigo carmine dye spraying and narrow band~     imaging (NBI) of colonic mucosa to detect dysplasia in ulcerative colitis (UC). Confocal~     laser microscopy may be beneficial in the further assessment of abnormalities identified by~     these methods.~   "
198710|NCT00961935|"~     The UCLA Semel Institute for Neuroscience in Los Angeles, CA, is conducting a study looking~     at similarities and differences in how the brain works between bipolar disorder and attention~     deficit hyperactivity disorder (ADHD).~   "
198711|NCT00961922|"~     Introduction:~      The aim of this study is to investigate the efficacy of neurofeedback (NFB) to improve~     attention, memory and processing speed in children treated for a Brain Tumour (BT). In the~     Netherlands every year approximately 100 children are diagnosed with a BT. Nowadays over 65%~     of these children have a 5-year survival. Treatment for a BT consists of neurosurgery and /~     or local or craniospinal radiation and / or adjuvant chemotherapy. Neurotoxicity caused by~     radiotherapy and / or chemotherapy (especially methotrexate) is a major cause of~     neurocognitive decline in Childhood Brain Tumour Survivors (CBTS).~      Approach:~      Studies have shown that NFB has the capacity to improve the brain systems mediating selective~     attention and response inhibition in children with Attention Deficit/Hyperactive Disorder~     (ADHD). The effectiveness is reported as comparable to methylphenidate (Ritalin) without side~     effects of medication. CBTS exhibit symptoms comparable to those of children with ADHD and~     positive response to methylphenidate has been found in CBTS. However, NFB has not been used~     as an intervention in CBTS yet. The effectiveness of NFB in children treated for a BT will be~     investigated in a randomized controlled trial. The intervention group of 30 patients will~     receive approximately 30 sessions of NFB; the control group will receive 30 session of~     placebo neurofeedback. Neuropsychological tests will be used to evaluate pre- and post-NFB~     intervention as well as at a 6-month follow-up.~      Relevance:~      If NFB proofs to be effective for CBTS this will be a great improvement for their (neuro-)~     psychological functioning and quality of life, without the disadvantage of the side effects~     of medication. The implementation of this intervention might increase cognitive and social~     functioning and thus facilitate integration of these children in society during childhood and~     school carrier as well as in adult life.~   "
198712|NCT00961909|"~     This randomized, double-blind, placebo-controlled study will assess the efficacy, safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2~     diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously~     once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current~     stable doses of metformin.~   "
198713|NCT00961896|"~     Part I was a double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to~     evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple~     topical administrations of LDE225 (a specific Smoothened inhibitor) on skin basal cell~     carcinomas in Gorlin's syndrome patients.~      Following a 21-day screening period, patients were exposed to multiple doses of topically~     applied LDE225 twice daily for 4 weeks in a double-blind manner. The patients returned weekly~     for visits where each BCC was clinically evaluated and digital photographs taken. Local~     safety and tolerability was also assessed. After the last application of treatment, biopsies~     were taken from treated (both vehicle and LDE225) BCCs (three per patient) for histology,~     biomarker evaluation and for pharmacokinetics (skin exposure). In addition, a biopsy from~     LDE225-treated uninvolved perilesional skin was taken for pharmacokinetic evaluation. In~     total, 4 biopsies were taken: 2 for histology and biomarker and 2 for PK.~      Part II of this study consisted of a 21-day screening period, a baseline period (directly~     before commencing the treatment period) and a treatment period of 6 or 9 weeks, depending on~     randomization. A clinical assessment was performed on site on the last treatment day and if a~     full clinical response had been observed, approximately 3 weeks after the last treatment an~     excision of the BCC(s) would have been performed. The study completion visit occurred either~     1 week after the excision (when this visit was planned) or 1 week after the last treatment.~     For a subset of patients, skin biopsies were collected on the last treatment day and an~     excision of a BCC was also performed at that same visit.~   "
198714|NCT00961883|"~     Investigators will examine the safety of and immune responses to two vaccines expressing~     synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus). The study will~     compare responses in participants receiving NYVAC-B first, and rAd5 later, to those who~     receive rAd5 first, and NYVAC-B later. A different dose of rAd5 will be tested in each group.~   "
198715|NCT00961870|"~     This study hypothesize that radius subjecting to mechanical loading may affect excitability~     of alpha motor neuron innervating muscle, based on its bone mineral density. If this~     hypothesis is valid, it can be firstly suggested that the relationship between bone mineral~     density and muscle strength is bidirectional.~      A total of 80 voluntaries are planned to include in this study.~      After forearm vibration is applied, bone mineral density (BMD) and bone mineral content (BMC)~     will be measured in all cases. Alpha motor neuron excitability (H/M ratio, recruitment),~     background muscle activity will be evaluated by electromyography at pre-treatment,~     post-treatment and, during treatment in cases.~      Forearm vibration will be applied by forearm vibration device (FAV). FAV with mechanical~     loading will apply forearm. Cases will sit on armchair. Two intervals of FAV will be applied~     at a frequency of 45 Hz. Each interval will consist of 60 second of FAV followed by rest.~      The right radius BMD and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO).~      Motor unite potentials at rest, Hoffman reflex, F response, M response will be measured by~     electromyography at right flexor carpi radialis. Medtronic Keypoint Portable 2 channel~     electromyography and Neurotrac ETS device will be used.~   "
198716|NCT00961857|"~     A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image~     (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet~     and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg)~     as individual tablets. Subject will only participate in one part, receiving treatment A and B~     (Part I) or Treatment C and D (Part II).~   "
198717|NCT00961844|"~     In this trial the investigators want to combine chemotherapy with immunotherapy by giving the~     patients Temozolomide, before vaccination. The investigators have also included hTERT and~     survivin mRNA in the vaccine. Finally, the investigators want to introduce ex vivo T cell~     expansion after lymphodepletion for the patients who show an immune response.~   "
198718|NCT00961831|"~     This study is a visual assessment of diagnostic PET/CT images obtained after a single~     intravenous injection of BAY85-8050 in patients with cancer~   "
198719|NCT00961818|"~     The objective of this clinical and experimental study was to verify the immediate effect of~     vocal techniques: vibration, nasal sound and articulation in women without vocal complaints.~   "
198720|NCT00961805|"~     The aim of the present study is to assess the effectiveness of belly dance as a treatment for~     pain and improving the quality of life of patients with fibromyalgia.~      Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a~     dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks~     of belly dance twice a week, while the patients in the control group remained on a waiting~     list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute~     walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck~     Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder~     Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and~     after 32 weeks.~   "
198721|NCT00961792|"~     This study attempts to elucidate the factors that contribute to escalation and maintenance of~     excessive ethanol drinking in young adults by:~        1. Examining subjective and objective response differences to alcohol and other common~          substances in a sample of young, adult social drinkers with varying consumption~          patterns.~        2. Determining whether response to alcohol and other substances is predictive of future~          consumption patterns through longitudinal follow-up interviews.~        3. Examining the relationship between responses to alcohol and other substances at baseline~          and re-examination testing to evaluate if consumption patterns moderate this~          relationship.~   "
198722|NCT00961779|"~     The purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female~     volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female~     volunteers.~   "
198723|NCT00961766|"~     The primary objective of the study is to determine the safety/tolerability profile, systemic~     PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica~     participants.~   "
198724|NCT00961753|"~     The purpose of this study is to determine if increasing the ibuprofen dose will increase the~     likelihood of closing the patent ductus arteriosus in premature babies.~   "
198753|NCT00961337|"~     The purpose of this study is to determine whether inactivated influenza vaccines are~     effective to protect school children and their households from getting influenza infection~     and further prevent student's absenteeism.~   "
198725|NCT00961740|"~     The study is evaluating the effect of a 14-session cognitive behavioural treatment for~     childhood obesity. The treatment is family based and 49 families with children with obesity,~     aged 8-12, will be recruited. Outcome measures are: BMI, waist circumference, self-esteem,~     social- and psychological functioning, cholesterol, glucose and insulin values, activity~     level (actigraphs) and a measure of food intake.~   "
198726|NCT00961727|"~     Timely identification, referral and treatment of children who are clinically deteriorating~     while admitted to hospital wards is a fundamental element of inpatient care. In community~     hospitals, advantages including greater continuity of inpatient-outpatient care, improved~     geographic access for families, and lower healthcare system costs, may be undermined if~     children with evolving critical illness are not recognized and transferred in a timely~     manner. The Bedside Paediatric Early Warning System (Bedside PEWS) is a system of care~     designed to augment existing expertise and to provide a safety net for children who are~     clinically deteriorating while admitted to hospital wards. The Bedside PEWS is comprised of 4~     components; [1] an expert derived, multi-centre validated severity of illness score, [2] an~     inter-professionally developed documentation record into which the severity of illness score~     is embedded, [3] a series of score-matched care recommendations based on the opinions of over~     280 paediatric health care professionals, and [4] an educator-developed~     education-implementation program.~   "
198727|NCT00961714|"~     The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures~     by providing internal fixation and stabilization using a titanium implant in conjunction with~     OsseoFix+™ polymethylmethacrylate (PMMA) bone cement.~      The purpose of the study is to provide reasonable assurance on safety and effectiveness of~     the OsseoFix Spinal Fracture Reduction System for market release approval in the US.~      This investigational device is intended to restore biomechanical integrity to a vertebral~     body that has suffered a painful compression fracture in the thoracic or lumbar spine between~     levels T6 and L5.~   "
198728|NCT00961701|"~     Severe Primary hyperparathyroidism (PHP) has been associated with increased cardiovascular~     morbidity and mortality. Hypertension, dyslipidemia and impaired glucose tolerance were~     demonstrated in severe PHP, with improvement after surgery in these variables. Recent~     evidence suggests that the 'quality' rather than only the 'quantity' of low-density~     lipoprotein (LDL)-cholesterol exerts a direct influence on the cardiovascular risk. Thus, the~     proposed study protocol is intended to evaluate lipoprotein phenotype and LDL size and~     subclasses in patients with primary hyperparathyroidism.~   "
198729|NCT00961688|"~     Women with Polycystic Ovary Syndrome (PCOS) between the age of 18 and 55 are being recruited~     to participate in an online survey to determine the impact of PCOS on quality of life and~     interaction with the healthcare system. This online survey will take 15-20 minutes to~     complete. Participants will receive no direct benefit, but the information provided will~     contribute to the knowledge of this condition and the development of improved healthcare for~     women with PCOS. For more information or to participate in this study, please visit~     http://pcossurvey.vze.com~   "
198730|NCT00961675|"~     The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in~     the treatment of acute otitis externa. This study will be conducted at one site, the LBJ~     Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.~   "
198731|NCT00961662|"~     This study is a six-month, prospective, randomized, multicenter, single- blind, controlled~     clinical study to evaluate the effect of three low-doses of Naturlose (Tagatose) on glycemic~     control and safety in subjects with Type 2 diabetes under diet control and exercise. The~     subjects were randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose.~   "
198732|NCT00961649|"~     The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering~     efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to:~        -  its individual components (Brinz and Brim), and~        -  the concomitant administration of Brinz and Brim (Brinz+Brim).~   "
198733|NCT00961636|"~     This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms~     beyond 6 months and will measure the impact of withdrawal of laropiprant in patients~     following 20 weeks of stable maintenance therapy.~   "
198734|NCT00961623|"~     The diagnosis and monitoring of clinically-significant pathologies of the knee remains~     challenging, and it is unknown why only some injuries become painful or respond to surgical~     intervention. The limitations of diagnostic magnetic resonance imaging result in arthroscopy~     that is not always beneficial. Elucidation of biochemical pathways underlying pain in this~     condition may aid patient selection for surgery and provide pharmacotherapeutic targets.~     Cytokines or a novel yet uncharacterized protein may be involved in pain following meniscus~     injury and diagnostic cytokine assay may help physicians differentiate patients that may~     benefit from arthroscopy from those that may not. Additionally, evaluating post-operative~     biochemical profiles may provide a method of monitoring surgical outcome and understanding~     post-operative continuation or remission of pain.~   "
198735|NCT00961610|"~     This 2-arm randomized trial assessed the incremental effect of providing a lecture on~     Internet use followed by participation in an Internet-based peer support group following a~     week-long rehabilitation program, over and above any possible general effect of participation~     in the rehabilitation program.~      Primary outcome measures are adjustment to cancer and mood disturbance.~   "
198736|NCT00961597|"~     The purpose of this investigation is to determine the clinical outcome of repair of meniscus~     tears located in the red/white region using a well-known suture technique combined, when~     indicated, with platelet-rich plasma to enhance healing. The outcome of this operation will~     be determined in a consecutive group of patients with an established, rigorous knee rating~     system a minimum of 2 years postoperatively. Results will be determined by the analysis of~     subjective and functional factors, sports and occupational activity levels, a comprehensive~     physical examination, and a radiographic evaluation using standard plain x-rays and magnetic~     resonance imaging. The investigators hypothesize that meniscus repairs will significantly~     reduce tibiofemoral compartment pain and allow for increased knee function and activity~     levels. The platelet rich plasma adjunct will be used in complex meniscus tears in which a~     portion of the tear extends into the avascular region classified as either longitudinal,~     horizontal, or radial. The investigators hypothesize that the healing rate of these repairs~     will be superior to those previously reported in clinical studies in patients who had the~     suture repair technique alone.~   "
198737|NCT00961571|"~     This study is for patients with metastatic colorectal cancer who have not been treated with~     chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and~     Sunitinib can be used together to improve progression-free survival in colorectal cancer.~      All patients will take two medicines (Sunitinib and Capecitabine) by mouth every day until~     their cancer gets worse.~   "
198738|NCT00961558|"~     A varicocele is the presence of dilated testicular veins in the scrotum. Although it is~     generally agreed that a varicocele is the most common identifiable pathology in infertile men~     (detected in up to 40% of men in some series of men with infertility), the influence of a~     varicocele on male fertility potential and role of varicocelectomy in restoring of fertility~     remain the subject of ongoing controversy. The present controversy on the effect of~     varicocelectomy on male fertility potential has led many clinicians to dismiss the diagnosis~     of a varicocele altogether and instead, offer alternative treatments to the couple. Many of~     these alternative therapies are expensive and risky for the patients and their children.~     Several recent reviews have critically examined the results of randomized, controlled trials~     of varicocelectomy on fertility potential. The effect of varicocelectomy on spontaneous~     pregnancy rates remains controversial.~      The investigators hypothesize that a varicocelectomy will result in a significant improvement~     in fertility and testicular function in infertile men with a clinical varicocele.~   "
198739|NCT00961532|"~     The investigators intend to show that DDAVP improves platelet activity from baseline to 60~     minutes after treatment start.~   "
198740|NCT00961506|"~     Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and~     recovery compare to laparoscopic cholecystectomy.~   "
198741|NCT00961493|"~     The purpose of this study is to determine whether acceptance-based behavior therapy for GAD~     results in greater symptom reduction and increased quality of life than applied relaxation.~   "
198742|NCT00961480|"~     A three part study to demonstrate the bioequivalence of a single dose of the Final Market~     Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination~     (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as~     individual tablets. Subject will only participate in one part, receiving treatment A and B~     (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).~   "
198743|NCT00961467|"~     After the discovery of melphalan and prednisone (MP), many clinical trials evaluated the~     efficacy of combination chemotherapy, such as VMCP, VBAP, MOCCA in multiple myeloma (MM)~     patients, without significant clinical benefit. After 40 years, the combination of MP with~     thalidomide (MPT) or lenalidomide (MPR) or bortezomib (MPV) have finally and consistently~     shown additive or synergistic effects.In advanced MM, the combination of melphalan,~     prednisone and thalidomide induced 12% very good partial response (VGPR) rate, while the~     combination of melphalan and bortezomib showed 15% near complete remission (nCR) rate. In~     relapsed patients, the combination of bortezomib with MPT (VMPT) induced 43% VGPR rate.~     Preliminary results indicate that VMPT may induce a CR rate of around 50% in newly diagnosed~     patients (unpublished results).In preclinical studies thalidomide showed more~     anti-angiogenesis activity, while lenalidomide showed more immunomodulatory effects, thus~     suggesting a combined clinical approach for these two drugs. The toxicity profile of~     lenalidomide is completely different from that of thalidomide and no cumulative toxicities~     are expected, again suggesting a combination approach. This study will evaluate the safety~     and efficacy of combining Lenalidomide, Melphalan, Prednisone and Thalidomide (R-MPT) as~     salvage treatment for relapsed/refractory myeloma patients. This association might further~     increase the response rate achieved by the standard oral MPT or MPR regimens.~   "
198744|NCT00961454|"~     A pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in~     the frontal poles and to affect the emotional status of patients with major depression.~   "
198745|NCT00961441|"~     To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both~     children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.~   "
198746|NCT00961428|"~     The purpose of this research study is to determine the importance and level of physical~     activity in people with Anorexia Nervosa.~   "
198747|NCT00961415|"~     This open-label study will assess the efficacy and safety of Avastin with or without~     pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent~     non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with~     Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of~     each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive~     further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed~     (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease~     progression. Target sample size is <500 individuals.~   "
198748|NCT00961402|"~     The purpose of this study is to examine the feasibility and efficacy of an exercise~     intervention for the prevention of postpartum depression. If efficacious, our intervention~     could be disseminated in real world settings in an effort to prevent postpartum depression.~   "
198749|NCT00961389|"~     The objective of this study is to determine the incidence of delirium in adults patients who~     are admitted at the critical care unit of a Dutch University Hospital with the mapping of~     relevant delirium risk factors The primary aim is to validate the investigators' developed~     delirium prediction model for critical care patients.~      A secondary aim is to find differences between delirious patients and non-delirious patients~     on different aspects of diagnostics, treatment and care, outcome, length of stay, and~     inflammation.~      According to Dutch law, the need to obtain informed consent was waived by the Committee on~     Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).~   "
198750|NCT00961376|"~     The objective of this study is to evaluate the safety and immunologic effects of autologous~     tumor vaccination administered with human granulocyte-macrophage colony-simulating factor~     (hGM-CSF), and subsequent boosting vaccinations in patients made lymphopenic by treatment~     with chemotherapy and infused with autologous PBMC (Cohort A) or CD25 depleted PBMC (Cohort~     B). Clinical observations and laboratory measurements will be monitored to evaluate safety,~     toxicity, immune responses, and anti-tumor effects. Additionally, the effects of treatment on~     tumor response will be evaluated.~   "
198751|NCT00961363|"~     The purpose of this study is to examine the safety and efficacy of sitagliptin 100 mg every~     day (q.d.) in improving hyperglycemia and endothelial dysfunction in subjects with impaired~     glucose tolerance.~   "
198756|NCT00961298|"~     The investigators propose to evaluate the effectiveness of duloxetine in treating subjects~     with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The~     investigators hypothesize that duloxetine as a single therapeutic agent will effectively~     target pain and other core symptoms of IBS as well as GAD in this patient population with~     both conditions.~   "
198757|NCT00961285|"~     Identification of alterations potentially involved in the complex mechanisms of~     leukemogenesis and at the identification and validation of novel biological factors which may~     serve as predictors of drug-response and drug-resistance or which may be suitable for~     targeted therapy.~   "
198758|NCT00961272|"~     The purpose of this study is to characterize the pharmacokinetics of raltegravir in~     cervicovaginal fluids as compared to blood plasma of HIV-infected pre-menopausal women.~   "
198759|NCT00961259|"~     This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose~     and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total~     single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each~     dose is administered under fasted conditions. Safety and tolerability of these regimens will~     also be evaluated.~   "
198760|NCT00961246|"~     This study compares the feasibility and efficacy of an individually tailored, child-centered,~     Internet-based behavioral intervention with that of general Internet-based health information~     for improving health behaviors and relative weight in Chinese-American children during a~     6-month period. A total of 60 children (age 10-14) and their families will be randomized to~     either the intervention group or control group. The intervention is based on the Social~     Cognitive Theory and Transtheoretical Model.~   "
198761|NCT00961233|"~     The purpose of this study is to conduct a clinical trial of two formulations of budesonide~     (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if~     medication contact time and distribution in the esophagus relates to treatment response. The~     investigators will also determine if there is systemic absorption of these topical steroids.~     The investigators hypothesize that tissue and symptom response will correlate with esophageal~     medication contact time and distribution, and that significant systemic absorption will not~     be seen.~   "
198762|NCT00961220|"~     This phase I/II trial studies the side effects and best dose of carmustine when given~     together with O6-benzylguanine and to see how well they work in treating patients with stage~     IA-IIA cutaneous T-cell lymphoma. Drugs used in chemotherapy, such as carmustine, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. O6-benzylguanine may help carmustine work better by making cancer cells~     more sensitive to the drug. Giving O6-benzylguanine with carmustine may kill more cancer~     cells.~   "
198763|NCT00961207|"~     Study Hypothesis:~      Reduction in albuminuria has been shown to decrease progression of diabetic~      nephropathy. In diabetic nephropathy patients treated with maximal~      antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320~      mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent~      albuminuria reflects further additional RAAS activation. Microvascular renal~      disease due to increased RAAS activation may be more effectively treated with~      triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.~   "
198764|NCT00961194|"~     Nowadays, available drugs cannot always produce pain relief in patients with neuropathic pain~     disease.~      It is believed that drugs acting as antagonists of the N-methyl-D-aspartic acid (NMDA)~     receptor may have been efficient in the treatment of neuropathic pain disorders.~      Ketamine is the only NMDA receptor antagonist commercially available in France. Ketamine is~     usually administered intravenously for surgical anesthesia.~      The intravenous administration of ketamine will be difficult to manage in the treatment of~     chronic neuropathic pain.~      Some trials using oral ketamine for the treatment of neuropathic pain were conducted but~     results were heterogeneous. This may be explained by the different range of ketamine doses~     tested.~      The aim of this clinical trial is to identify a safe and an efficient dose of orally~     administrated ketamine for the treatment of peripheral neuropathic pain.~      The clinical trial will be conducted in Toulouse Hospital, France. This study is a~     randomized, double-blind, placebo-controlled trial. The study will be conducted using 4~     parallel groups (three doses of ketamine versus placebo).~   "
198765|NCT00961181|"~     The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel~     releasing balloon in patients with in-stent restenosis in a coronary artery.~   "
198766|NCT00961168|"~     The primary goal of this study is to measure changes in biological markers of inflammation in~     critically-ill patients with acute lung injury (ALI) or acute respiratory distress syndrome~     (ARDS) while they are treated with different styles of lung-protective, artificial breathing~     assistance.~      Secondary goals are to measure the breathing effort of patients using different artificial~     breathing patterns from the breathing machine.~      The primary hypothesis is that volume-targeted artificial patterns will produce less~     inflammation. The secondary hypothesis is that volume-targeted artificial patterns will~     increase breathing effort compared to pressure-targeted artificial patterns.~   "
198767|NCT00961155|"~     Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment~     of airway inflammation, and it provides information on airway lining fluid composition.~     Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy~     and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very~     uncomfortable procedure especially for young patients. The aim of this study is to evaluate~     the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway~     inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma~     allergic to house dust mite. Also, we aim to assess correlations between cytokine~     concentrations in EBC and clinical characteristic of the patients with exercise-induced~     bronchoconstriction as another phenotype of asthma.~   "
198768|NCT00961142|"~     Feasibility and toxicity of haploidentical allogeneic HCT after a reduced intensity~     conditioning regimen with CD3/CD19 depleted grafts. This study enrolls patients with acute~     leukemia in complete remission with an indication for allogeneic HCT but without a suitable~     HLA-identical donor~   "
198769|NCT00961129|"~     The aims of this study are to:~        1. explore supportive care needs in colorectal cancer patients with treatment and~          survivors;~        2. compare the supportive care needs in different stage of colorectal cancer;~        3. identify the significant factors for the supportive care needs;~        4. explore the supportive care needs within one year after newly diagnosis.~   "
198770|NCT00961116|"~     This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145~     mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective~     is to characterize the pharmacokinetic profile of fenofibric acid when administered as a~     single 105 mg dose to healthy volunteers in a fasted state. Safety and tolerability of this~     regimen will also be evaluated.~   "
198771|NCT00961103|"~     Spinal Muscular Atrophy (SMA) is neurodegenerative disease of anterior horn cells of spinal~     cord and represents the second more frequent pathology in childhood.~      According to the age of onset and the maximum motor function the disorder is classified in 4~     types. Patients with SMA II and SMA III often use orthoses to achieve postural and dynamic~     functions.~      In this retrospective observational study the investigators describe the characteristics of~     sitting position, standing and walking correlated to type and time of orthoses used.~   "
198772|NCT00961090|"~     A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible~     under ultraviolet light which allow the surgeon to see more of the tumor for a more complete~     removal.~   "
198773|NCT00961077|"~     Stomach cancer is the most common malignant disease and the second most common cause of~     cancer-related deaths in the Korea. The elderly are primarily affected by the disease with~     most gastric cancer-related deaths occuring in patients aged 65 years or older. Systemic~     chemotherapy improves the quantity and quality of life in patients with gastric cancer when~     compared with best supportive care. However, elderly cancer patients often present with~     concomitant co-morbidities and age-associated physiologic problems that make the selection of~     optimal treatment difficult. There is also uncertainty about the use of systemic palliative~     chemotherapy in elderly patients because of under representation of this age group in~     clinical trials. Therefore, this phase II trial was planned to investigate efficacy and~     toxicities of combination chemotherapy with attenuated dose of S-1 and oxaliplatin~     (attenuated SOX)in patients with elderly AGC~   "
198774|NCT00961064|"~     Background:~        -  Myelodysplastic syndromes (MDS) are bone marrow disorders characterized by anemia,~          neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet~          counts). Patients with MDS are at risk for symptomatic anemia, infection, and bleeding,~          as well as a risk of progression to acute leukemia. Standard treatments for MDS have~          significant relapse rates. MDS patients with thrombocytopenia who fail standard~          therapies require regular, expensive, and inconvenient platelet transfusions, and are at~          risk for further serious bleeding complications.~        -  Eltrombopag is a drug designed to mimic the protein thrombopoietin, which causes the~          body to make more platelets. Eltrombopag has been able to increase platelet counts in~          healthy volunteers and in patients with chronic ITP (a disease where patients destroy~          their own platelets very rapidly and thus develop thrombocytopenia), but researchers do~          not know if the drug can increase platelet counts in patients with MDS.~      Objectives:~        -  To find out whether eltrombopag can improve platelet counts in patients with MDS.~        -  To determine whether eltrombopag is safe for patients with MDS.~      Eligibility:~      - Patients 18 years of age and older who have consistently low blood platelet counts related~     to MDS that has not responded to conventional treatment.~      Design:~        -  Treatment with eltrombopag tablets once per day for 90 days.~        -  Participants will be monitored closely throughout the initial treatment, with weekly~          blood tests and separate evaluations at the National Institutes of Health (NIH)~          treatment center every 4 weeks. Bone marrow biopsies may be conducted to check for~          abnormalities in bone marrow.~        -  If patients show signs of improved platelet counts after 90 days, treatment will~          continue with additional doses of eltrombopag.~        -  Patients who discontinue taking eltrombopag will be evaluated at the NIH treatment~          center 4 weeks after ending treatment, and again 6 months after ending treatment to~          check for potential side effects.~   "
198775|NCT00961051|"~     The purpose of this study is to evaluate the safety and effectiveness of an investigational~     multi-purpose contact lens solution.~   "
198776|NCT00961038|"~     Objectives of the study are to investigate the safety, tolerability and levels of~     ciprofloxacin in the lung after single and multiple inhalative administration to patients~     with moderate to severe COPD (stage II-III according to GOLD Criteria)~   "
198777|NCT00961025|"~     This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing,~     dose-escalation study. The study is designed to describe the relationship between multiple~     doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.~   "
198778|NCT00961012|"~     Older adults with a disability tend to spend greater periods of time in bed each day and~     often over a mealtime. To make it safe for them to eat in bed, the patient is placed in a~     high Fowler's position. This means that the head and the foot of the bed are raised to sit~     the person up.~      Sitting up in bed increases pressure over the buttocks which can lead to the development of a~     pressure ulcer. The purpose of this study is to evaluate the impact of the positional change~     called the trunk release on pressure over the buttocks, on breathing and on comfort.~      Primary Hypothesis - Performing the trunk release with an older adult population at low risk~     for pressure ulcer will result in a 5mmHg decrease in the peak pressure index over the~     sacral-coccygeal area as measured by the peak pressure index using a Force Sensitive~     Applications (FSA) Pressure Mapping System.~      Secondary Hypotheses - Performing the trunk release with an older adult population at low~     risk for pressure ulcer will result in:~        -  Improved ventilation as measured by a 0.5 liter increase in slow vital capacity.~        -  Greater comfort as measured by a two point change on a horizontal numeric scale with~          word anchors combined with the Wong-Baker faces scale (Appendix D).~        -  A four-centimetre displacement of the trunk as it extends up towards the head of the~          bed.~   "
198779|NCT00960999|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. It is not yet known which regimen of~     stereotactic body radiation therapy is more effective in treating patients with non-small~     cell lung cancer.~      PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy~     regimens and to see how well they work in treating patients with stage I non-small cell lung~     cancer.~   "
198780|NCT00960986|"~     The purpose of this study is to assess nausea severity in response to four different drug~     dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60~     mg without food) in Korean patients with major depressive disorder (MDD).~   "
198781|NCT00960973|"~     The purpose of this study is to test whether vitamin K supplementation has an effect on~     glucose metabolism in terms of acute beta cell response.~   "
198782|NCT00960960|"~     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or~     intravenous (IV) paclitaxel with and without IV bevacizumab or IV trastuzumab in participants~     with locally recurrent or metastatic breast cancer. The study consists of three parts. Part 1~     (pictilisib will be administered in 21+7 schedule along with paclitaxel and/or bevacizumab),~     Part 2 (pictilisib will be administered in 5+2 schedule along with paclitaxel and/or~     bevacizumab or trastuzumab) and Part 3 (pictilisib will be administered in combination with~     letrozole). Part 1 and Part 2 consists of two stages; a dose escalation stage and a~     cohort-expansion stage.~   "
198783|NCT00960934|"~     The purpose of this study was to identify an appropriate dose of~      MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal~     women with osteoporosis.~   "
198784|NCT00960921|"~     Body iron levels may be important in determining how the blood pressure in the lungs changes~     in response to low oxygen levels. At high altitude, where oxygen levels are low, some~     patients develop elevated lung blood pressure. The investigators hypothesize that, in high~     altitude residents with elevated lung blood pressure, iron supplementation will cause a~     reduction in lung blood pressure.~   "
198785|NCT00960908|"~     The objective of this study is to evaluate the safety and long-term effectiveness of coronary~     stenting with the zotarolimus eluting stent (ZES) and to determine clinical device and~     procedural success during commercial use of ZES.~      The investigators will compare 2nd generation ZE (Endeavor resolute, active prospective arm)~     with 1st generation ZES (Endeavor Sprint, retrospective arm).~   "
198786|NCT00960895|"~     This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary~     pulmonary hypertension.~   "
198787|NCT00960882|"~     The purpose of this study is to determine the gastric tolerability and the pharmacokinetics~     of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.~   "
198788|NCT00960869|"~     Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for~     developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.~   "
198789|NCT00960856|"~     The primary objective of this study is to characterize the single-dose pharmacokinetic~     profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat~     compositions on the rate and extent of absorption. Additionally, the safety and tolerability~     of this dose and regimen of fenofibric acid will be evaluated.~   "
198790|NCT00960843|"~     The purpose of this protocol is to determine how band fill volumes that are based on~     intraband pressure readings can influence the comfortability of the band and to compare~     weight loss with this methodology to weight loss with the conventional approach recommended~     in existing product labeling.~   "
198791|NCT00960830|"~     The purpose of this study is to evaluate if the use of antidepressant medication in depressed~     patients with implantable cardioverter defibrillator reduces the number of ICD's shocks as it~     improves depressive affect.~   "
198792|NCT00960817|"~     The investigators will investigate patients undergoing coronary angiography with normal~     coronary but slow blood flow that was normalized after adenosine injection into the coronary~     artery. The investigators believe that they have small vessel coronary disease which is the~     initial presentation of coronary disease prior to anatomical narrowing. To alleviate this~     phenomenon the investigators intend to examine the long-term clinical response of these~     patients to treatment with dipyridamole, a well-known medication with almost no side-effects~     that increases the level of adenosine in the tissue.~   "
198793|NCT00960804|"~     Tanezumab, administered for up to 1 1/2 years, reduces the pain of osteoarthritis without~     affecting how nerve impulses are transmitted in sensory nerves~   "
198794|NCT00960791|"~     The purpose of the study is to evaluate the absorption, distribution, metabolism and~     excretion of AZD1656 after administration of a single oral dose of 14C-labelled AZD1656~     solution in male Type 2 Diabetes Mellitus patients.~   "
198795|NCT00960778|"~     This study will investigate the underlying neurobiology of differences between male and~     female smokers. Research suggests that women are less responsive to nicotine replacement~     therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking.~     This study proposed that male smokers will have a greater response to NRT demonstrated by~     reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional~     magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues~     as compared to female smokers treated with NRT. Additionally, female smokers will have a~     greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and~     less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.~   "
198796|NCT00960765|"~     This research project is designed to investigate endotoxin (a toxin present in the wall of~     certain kinds of bacteria) levels and the type of bacteria present in the intestine before~     and after Roux-en-Y gastric bypass or gastric banding surgery in patients that meet the~     classification for morbid obesity (body mass index >40 kg/m2) and type 2 diabetes. It is~     known that the type of bacteria present in the intestines of normal weight and obese~     individuals are different, and it is also known that people with obesity and type 2 diabetes~     have higher levels of endotoxin. It has been shown that the bacteria change over the long run~     after Roux-en-Y gastric bypass surgery, but the short-term effects are not known and the~     endotoxin levels after this procedure have never been studied.~   "
198797|NCT00960752|"~     The goal of this clinical research study is to learn if the vaccines, gp100(g209-2M), and~     MAGE-3, when given in combination with resiquimod (R848), can help to stimulate the immune~     system against melanoma.~   "
198798|NCT00960739|"~     RATIONALE: Radioactive drugs, such as iodobenzylguanidine meta-I131, may carry radiation~     directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as~     topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. A stem cell transplant may be able to~     replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan~     hydrochloride.~      PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131~     given together with topotecan hydrochloride and to see how well it works in treating young~     patients with refractory or relapsed metastatic neuroblastoma.~   "
198803|NCT00960674|"~     Tactile massage is a gentle form of massage that probably exerts its effect through~     relaxation. In a pilot study of 11 subjects an effect on HbA1c of 0.8%-units was seen.~      The study aimed at comparing the effect of tactile massage sessions for one hour given once a~     week for 10 weeks in comparison with relaxation through a relaxation CD performed once a week~     during 10 weeks. Primary outcome was HbA1c measured after completed intervention and after~     yet another 12 weeks. Secondary outcomes were quality of life by SF-36, other markers of~     metabolism (fasting glucose, insulin resistance by HOMA-model), inflammation (CRP, cytokines)~     and stress (cortisone, catecholamines).~   "
198804|NCT00960661|"~     The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a~     day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine~     (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects~     with Type 2 Diabetes Mellitus who have inadequate glycemic control.~   "
198805|NCT00960648|"~     The objective of this study is to evaluate the safety and long-term effectiveness of coronary~     stenting with the everolimus-eluting stent (EES) and to determine clinical device and~     procedural success during commercial use of EES in the real world.~      The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting~     stent (SES, Cypher, retrospective arm).~   "
198806|NCT00960635|"~     This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the~     daily intake of 1,25-dihydroxy-vitamin D3 [1,25(OH)2D3], improves beta cell function in~     patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral~     administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time~     without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed~     meal tolerance test are measured at the beginning of the study, as well as at the end of the~     treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no~     difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at~     month 18.~   "
198807|NCT00960622|"~     Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to~     switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on~     Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after~     randomization to either continuing on trizivir or combivir, or to switching to Truvada.~     Measurements include maximal or peak oxygen consumption, lactate production and clearance,~     subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat~     contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is~     that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors~     (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction~     in several organ systems.~   "
198808|NCT00960609|"~     The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its~     rationale from living donor liver transplantation (LDLT). Parenchymal sparing procedures~     although HVs are resected suggest that probably their presence is underestimated.~      Taking profit from new improvements in ultrasound technology the investigators aim to better~     estimate the rate of CVs in a consecutive series of patients in whom resection of one HV at~     caval confluence is needed.~   "
198809|NCT00960596|"~     Under environmental intervention programs, to explore the associations between Environmental~     Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between~     different groups.~   "
198810|NCT00960583|"~     The purpose of the study is to compare, after functional multidisciplinary rehabilitation for~     chronic low back pain, an exercise program to the routine follow-up which is simply to advice~     patients to exercise regularly at home. The exercise program should help patients stay~     active, which should translate into a better long term quality of life and decreased days off~     work.~   "
198811|NCT00960570|"~     Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an~     inhibitor of CYP 2B6. This study will evaluate the effect of multiple doses of fenofibric~     acid at steady-state on the pharmacokinetics of single-dose efavirenz in healthy adult~     subjects.~   "
198812|NCT00960557|"~     The purpose of this study is to determine the safety and tolerability of OXi4503 in subjects~     with relapsed or refractory carcinomas with hepatic tumor burden.~   "
198813|NCT00960544|"~     The goal of this clinical research study is to find out how gene expression (as well as how~     often this expression occurs) in patients with breast cancer affects how Xeloda®~     (capecitabine) is cleared (passed through the urine) from the body. The safety of~     capecitabine will also be studied.~   "
198814|NCT00960531|"~     The purpose of this study is to assess the long term safety, tolerability, and immunogenicity~     of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate~     Alzheimer's disease.~   "
198815|NCT00960518|"~     Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies in China, and~     approximately 90% of the patients with HCC are also infected with hepatitis B virus (HBV).~     For patients with unresectable disease, the goal of palliative treatment is to control~     symptoms and prolong survival. Transarterial chemoembolization (TACE) using iodized oil and~     chemotherapeutic agents combines the effect of targeted chemotherapy with that of ischemic~     necrosis induced by arterial embolization. It can be administered repeatedly and can prolong~     survival in patients with unresectable hypervascular HCC. The long-term prognosis, however,~     remains guarded because of frequent development of locoregional tumor recurrence, which,~     together with concomitant hepatic decompensation, is the main cause of death. Adefovir works~     by blocking reverse transcriptase, an enzyme that is crucial for the hepatitis B virus (HBV)~     to reproduce in the body. Based on these results, the investigators conducted a randomized~     controlled trial to test the hypothesis that adefovir treatment would reduce or postpone the~     recurrence rate and improve the overall survival rate in patients after TACE treatment of~     HBV-related unresectable HCC.~   "
198816|NCT00960505|"~     The proposed research will demonstrate that alternate day modified fasting (ADMF) is a~     suitable alternative to daily calorie restriction (CR) for weight loss, weight maintenance,~     and heart disease prevention. Since many overweight and obese individuals find it difficult~     to adhere to daily CR, this diet option may improve adherence with these dietary restriction~     protocols. This, in turn, will allow a greater percent of the overweight and obese population~     to lose weight, maintain weight loss, and prevent future occurrences of coronary heart~     disease.~   "
198817|NCT00960492|"~     The purpose of this study is to determine the highest safe dose of XL184 administered orally~     in combination with temozolomide (TMZ, Temodar®) and radiation therapy (RT). XL184 is a new~     chemical entity that inhibits VEGFR2, MET, and RET, kinases implicated in tumor formation,~     growth and migration. Temozolomide (TMZ, Temodar®) is an orally administered alkylating~     agent. It is approved by the Food and Drug Administration (FDA) for the treatment of newly~     diagnosed glioblastoma (GB) patients when given in combination with radiation therapy (RT)~     followed by maintenance treatment. First-line treatment for patients with GB consists of a~     concurrent phase (6-7 weeks in duration) during which TMZ is given with RT, followed by a~     rest phase (4 weeks in duration; to allow for recovery from delayed toxicity, if present),~     and a maintenance phase, during which patients receive TMZ for approximately twelve 28-day~     cycles. To determine the highest safe dose, subjects will receive different amounts of XL184~     at different times according to the phase of TMZ and radiation therapy. The first group of~     subjects will receive the lowest dose of XL184. As long as no medically unacceptable side~     effects are noted, the dose will be increased for the next group. If the dose is not~     well-tolerated by the first group of subjects, the dose will be lowered for the next group.~   "
198818|NCT00960479|"~     The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200~     capsules and Rebetol 200 mg capsules in females under fasting conditions.~   "
198819|NCT00960466|"~     The diagnosis and treatment of cancer has been shown to lead to very high levels of distress~     among patients. Although treatments for a range of different cancers have become much better~     in recent years, the distress that accompanies diagnosis and treatment can have serious~     negative effects for patients. Research has shown that, for a number of reasons, patients~     find it difficult to inform healthcare professionals about the cause of their distress~     whether it is physical (e.g. pain), psychological (anxiety and depression), personal partners~     and family) or social (finances). Also, medical staff often fail to detect even high levels~     of distress. This means that a great deal of distress is not being treated and this may lead~     to more hospital and GP visits, and dissatisfaction with care. The Distress Thermometer and~     Problem List (DT&PL) is a simple method of identifying distress in cancer patients using the~     familiar image of a thermometer. It offers patients a list of common treatment-related~     difficulties to help them identify any problems that cause distress. A trained staff member~     uses the DT&PL to discuss with the patient different options for addressing each concern:~     directly where possible (action taken by the patient or the staff member present) or leading~     to a referral to a specialist where necessary. Our research aims to measure whether the DT&PL~     is effective in quickly identifying and treating cancer-related distress and therefore~     preventing longer-term problems developing. The investigators also want to know whether~     patients find it helpful to complete the DT&PL and whether using the DT&PL saves NHS time and~     money.~   "
198820|NCT00960453|"~     The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of~     sitagliptin in healthy volunteers.~   "
198821|NCT00960440|"~     This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients~     taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor~     treatment.~   "
198822|NCT00960427|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients respond to~     treatment.~      PURPOSE: This phase I trial is studying biomarkers in tumor tissue and blood samples from~     patients undergoing chemotherapy and radiation therapy for stage II or stage III rectal~     cancer that can be removed by surgery.~   "
198823|NCT00960414|"~     The purpose of this study is to compare two approaches to a diet and exercise-based weight~     loss program.~   "
198824|NCT00960401|"~     The purpose of this study is to compare plaque burden in the coronary and carotid arteries 5~     years after adjuvant radiotherapy in women with right sided breast cancer vs left sided~     breast cancer.~   "
198825|NCT00960375|"~     The investigators have developed an intervention called Behavioral Treatment of Smoking~     Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and~     education with contingency management and a multifaceted behavioral group treatment program~     that lasts for three months (24 group meetings). BTSCS is designed to address the cognitive,~     motivational, and social support problems characteristic of people with SPMI.~      The investigators propose to conduct a randomized trial for persons with SPMI that compares~     (1) BTSCS: a 6-month manualized smoking cessation program adapted from an effective substance~     abuse treatment program for this population to (2) StSST: a standard manualized smoking~     cessation program which reflects current best practices.~   "
198826|NCT00960362|"~     This trial is conducted in North America. The aim of this clinical trial is to investigate~     the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses~     of AGS-009 in patients with systemic lupus erythematosus (SLE).~   "
198827|NCT00960349|"~     The primary objective of the study is to assess the safety and tolerability of cediranib in~     combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese patients~     with previously untreated locally advanced or metastatic unresectable gastric cancer (GC).~   "
198828|NCT00960336|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing.~      PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as~     first-line therapy in treating older women with metastatic breast cancer.~   "
198829|NCT00960323|"~     Colchicine is a substrate for cytochrome P450 3A4 (CYP3A4). In-vitro studies have indicated~     that the ortho-and para-hydroxylated metabolites of atorvastatin may be CYP3A4/5 competitive~     and mechanism-based inhibitors (MBI). This study will evaluate the effect of multiple doses~     of atorvastatin on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A~     secondary objective is to evaluate the safety and tolerability of this regimen in healthy~     volunteers. All study subjects will be monitored for adverse events throughout the study~     period.~   "
198830|NCT00960310|"~     The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50~     mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.~   "
199933|NCT00945763|"~     To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction~     surgery.~   "
198831|NCT00960297|"~     The rationale for this multicenter, phase II trial is to examine the impact of~     carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage~     IB (> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and~     active in this setting, this would provide rationale for further investigation in a larger,~     prospective, randomized setting.~   "
198832|NCT00960284|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin,~     epirubicin hydrochloride, fluorouracil, and capecitabine, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether~     gemcitabine hydrochloride is more effective when given alone or together with combination~     chemotherapy and radiation therapy in treating patients with pancreatic cancer.~      PURPOSE: This randomized phase II/III trial is studying gemcitabine hydrochloride to see how~     well it works when given alone or together with combination chemotherapy and radiation~     therapy in treating patients with stage IB, stage II, or stage III pancreatic cancer.~   "
198833|NCT00960271|"~     This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non~     small cell lung cancer staging. This controlled multicentric study will be conducted in 22~     centers in France. The study design includes two prospective phases. In phase 1, one~     investigator in each center will prospectively be evaluated for its ability to perform EBUS,~     with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2~     will include the medico-economic assessment of the technique in the preoperative setting. A~     maximum of 420 patients for each phase is forecasted.~   "
198834|NCT00960258|"~     This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg~     once daily administered orally as a single agent in Japanese patients with advanced solid~     tumors.~   "
198835|NCT00960245|"~     The purpose of this study is to demonstrate the relative bioavailability of Nadolol (1 x 80~     mg) tablets under fasting conditions.~   "
198836|NCT00960232|"~     There are numerous indications for a relation between low serum levels of 25(OH)D and blood~     pressure, lipid levels, frequency of infections and tendency towards depression. Whether it~     is a causal relationship it is not known, and can best be studied with a vitamin D~     intervention. The investigators hypothesis is that supplementation with a high dose vitamin D~     (40.000 IU per week) will have a beneficial effect on these parameters.~   "
198837|NCT00960219|"~     Adjuvant N-methyl-D-aspartic acid (NMDA)-enhancing agents, such as GlyT-1 inhibitors and~     NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia~     patients. The purpose of this study is to evaluate efficacy and safety of add-on treatment of~     an inhibitor of D-amino acid oxidase (DAAOI), DAAOI-1, in chronically stable schizophrenia~     patients who have been stabilized with antipsychotics.~   "
198838|NCT00960206|"~     The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to~     demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with~     the appropriate shell in a cementless application.~   "
198839|NCT00960193|"~     Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one~     of the enzymes responsible for the metabolism of colchicine. This study will evaluate the~     effect of multiple daily consumptions of Seville orange juice on the pharmacokinetic profile~     of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and~     tolerability of this regimen in healthy volunteers. All study subjects will be monitored for~     adverse events throughout the study period.~   "
198840|NCT00960180|"~     This is a first-in-human study of MR1817. This study will provide an initial assessment of~     the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after~     administration of ascending single oral doses to healthy adult subjects.~   "
198841|NCT00960167|"~     Hepatocellular carcinoma (HCC) is one of the leading malignancies in Taiwan. Surgery and~     local ablative therapy remain the treatment of choice for curative purpose. Transarterial~     chemoembolization has been the mainstay of intrahepatic control for patients not being~     candidates for local modalities of treatment. Sorafenib is recently integrated into the~     treatment options, mainly for intrahepatic or extrahepatic wide spread disease~     contraindicated for the other modalities. External radiotherapy (RT) has been selectively~     used for patients with the localized hepatic tumor(s) refractory to the above treatment~     options. The data from the retrospective studies were biased by the patient selection and~     uncontrolled comparison with patients not receiving RT. The obstacles for RT to HCC remain~     unanswered with heterogeneity in dose of radiation and lower tolerance of liver to RT in~     viral hepatitis carriers. Such a sublethal dose might be associated with unsatisfactory tumor~     control, intra-/extra-hepatic metastasis, and radiation-induced liver disease in a~     significant proportion of HCC patients.~      The purposes of this phase I study are primarily to determine the maximally tolerated dose of~     RT, and secondarily to evaluate the tumor control, to assess patterns of failure and~     survival, to analyze the characteristics of radiation-induced liver disease, as well as to~     collect blood samples for translational research. HCC patients who are hepatitis B virus~     carriers and graded as Child-Pugh A cirrhosis are enrolled. This dose escalation trial is~     conducted with the 7-Gy increase in 2 fractions (3.5 Gy per fraction) for a total of four~     levels, from 42 Gy up to 63 Gy. Conformal RT with three-dimensional design, intensity~     modulated RT, or volumetric modulated arc therapy is used with the defined dose-volume~     threshold for normal liver and the other structures. Five patients are treated for each dose~     level, with dose limiting toxicity in less than 2 patients judged to be acceptable. A minimum~     of 15 patients are required for the starting dose level of 49 Gy if the treated tumor~     diameter is less than 10 cm. Imaging modalities are used for estimating treatment response~     and detecting metastasis. Serum analyses are done for evaluating hepatic function, viral~     load, hematological toxicity, and translational research for angiogenic and inflammatory~     studies.~   "
198842|NCT00960154|"~     The purpose of this clinical study is to quantify the difference in thermal injury depth at~     the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to~     subjectively assess histopathologic sample quality metrics; to examine the role that~     electrosurgical artifact may play in revision lumpectomy procedures; and to compare these~     endpoints to the standard of care (SOC) technology.~   "
198843|NCT00960141|"~     A study of the ability of montelukast to improve signs and symptoms of seasonal allergic~     rhinitis compared with placebo. Loratadine is included in the study as an active control.~   "
198844|NCT00960128|"~     This observational study is conducted globally. The aim of the study is to investigate the~     effectiveness and safety of real-life treatment with Norditropin®. The study population will~     consist of children and adults who are on treatment with Norditropin® in accordance with~     normal clinical practice.~   "
198845|NCT00960115|"~     This is a phase I/II study in Japan to evaluate the safety of EMD531444 and its effects on~     survival time in patients with stage III unresectable non-small cell lung cancer.~   "
198846|NCT00960102|"~     The purpose of this study is to evaluate short and long term outcomes (benefits and~     side-effects) of bilateral cochlear implantation in Finnish children.~   "
198847|NCT00960089|"~     There is a major clinical need for an inexpensive topically-applied product that can inhibit~     the growth of the dermatophytes that cause nail fungus. Chesson Labs has developed LIQUICURE~     with a longer drying/curing time that will allow better nail penetration or adsorption.~     Though the product may have inherent antimicrobial activity, the product does not contain a~     drug or antimicrobial agent.~      Consistent use of LIQUICURE as described will clear fungal nail infection. Clearing of nail~     fungal infection is defined by negative dermatophyte culture and visual improvement in nail~     characteristics within six months, with few, if any product-related adverse events.~   "
198848|NCT00960076|"~     The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and~     Metformin XR vs. uptitrated Metformin XR.~   "
198849|NCT00960063|"~     This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH~     717454, MK-7454) administered in combination with chemotherapy in pediatric participants with~     solid tumors, to be conducted in conformance with Good Clinical Practices. This study will~     evaluate the safety, tolerability and dose-finding of robatumumab when administered in~     combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and~     vincristine (Arm B), or ifosfamide and etoposide (Arm C).~      The primary study hypothesis is that robatumumab can be safely administered in combination~     with chemotherapy regimens in pediatric participants with solid tumors.~   "
198850|NCT00960037|"~     This study is an extension of an earlier study of vitamin D supplementation conducted on~     normal weight individuals by Dr. John Aloia of the Bone Mineral Research Division at Winthrop~     University Hospital. The investigators plan to compare the response to vitamin D~     supplementation in obese individuals with the response already measured in normal weight~     individuals. The same dosing schedule of vitamin supplementation will be used as in the past.~     The doses used in the past have demonstrated safety in a number of trials, here at Winthrop~     as well as outside of Winthrop Hospital. Sixty study volunteers are planned for enrollment in~     the study. The study participants will mainly be recruited from a group of patients who have~     in the past been enrolled in the weight loss program at Winthrop Hospital. Each participant~     will be on vitamin D supplementation for a total of 8 weeks. Vitamin D blood levels will be~     measured before and at the end of the supplementation period. They will then be compared to~     see the change over time as a result of supplementation.~   "
198851|NCT00960024|"~     This project aims at generating evidence of a work-rehabilitation strategy that benefits the~     people with severe mental illness (SMI) who want to work, increase their sense of well-being~     and integration in society, decrease their financial dependence and experiences of stigma and~     discrimination. The project is likely to help form the basis of how to implement the evidence~     based supported employment (SE)-model, Individual Placement and Support model (IPS), in a~     Swedish work-rehabilitation context. In the long run, evidence of SE in a Swedish context~     could help to decrease the period of sick-leave and increase fulfilling and productive~     lifestyles among people with severe mental illness. In all, the effectiveness of SE can~     improve the quality of life for the target group, the quality in mental health care~     rehabilitation and decrease the costs of treatment and care.~   "
198852|NCT00960011|"~     Tension-less mesh repair is the most common procedure for inguinal hernia. Conventional heavy~     weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is~     responsible for mesh shrinkage and postoperative chronic groin pain. Moreover, the fixation~     of the mesh with sutures is a tedious procedure and accounts for the majority of the~     operating time. A self gripping semi-absorbable mesh has been developed for anterior tension~     free inguinal hernia repair. It has the benefit of light weight property and does not require~     sutures for fixation. This study aims to compare the outcome of this self-gripping light~     weight mesh with the conventional heavy weight polypropylene mesh in inguinal hernia repair.~   "
198853|NCT00959998|"~     Persistent cancer related fatigue (PCRF) is a common symptom experienced by many cancer~     survivors, which may last for as long as 10 years following treatment. PCRF is currently~     under diagnosed, with between 20% to >60% of survivors experiencing this symptom. Currently~     there are few effective treatment options for these patients. Acupressure offers a potential~     low-toxicity self-administered treatment option to treat PCRF.~      The investigators performed a pilot randomized single-blinded controlled trial of acupressure~     in cancer survivors experiencing moderate to severe PCRF. Potential participants were~     excluded if they had other causes of fatigue such as anemia, malnutrition, or chronic fatigue~     syndrome. Participants were randomized to one of three treatment groups: 1. relaxation~     acupressure (RA), 2. high intensity stimulatory acupressure (HIS), and 3. low intensity~     stimulatory acupressure (LIS). Participants performed acupressure for 12 weeks between 3 to~     14 times per week depending on group. Fatigue was measured with the Brief Fatigue Inventory~     (BFI). Secondary outcomes included beliefs and expectations, assessment of blinding,~     compliance to treatment, demographics, and clinical parameters. The effect of group on BFI~     was assessed with ANOVA and linear regression. Correlations were also made between compliance~     and change in BFI.~   "
198854|NCT00959985|"~     Women who have been treated for breast cancer may be at risk for lymphedema or arm swelling.~     Currently, there are no clear treatment guidelines for lymphedema. One treatment method used~     to treat lymphedema is the use of compression sleeves to encourage the flow of lymph fluid~     out of the arms and prevent arm swelling in the future. Another treatment method is more~     intensive and involves wearing compression sleeves as well as special compression bandages~     overnight. It is unclear whether the use of compression with both sleeves and bandaging is~     more effective in treating lymphedema than the use of compression sleeves alone. The purpose~     of this research study is to evaluate the effectiveness of the use of compression garments in~     preventing or slowing the progression of lymphedema in breast cancer patients.~   "
198855|NCT00959972|"~     The purpose of this study is to determine if a new drug, varenicline, for smoking cessation~     is more effective than the standard nicotine replacement therapy aide currently used, the~     patch among smokers hospitalized with coronary heart disease.~   "
198856|NCT00959959|"~     The purpose of this study is to determine whether TOK-001 is safe and shows biological effect~     in the treatment of castration resistant prostate cancer (CRPC).~   "
198868|NCT00959803|"~     This study is designed to investigate the safety, tolerability, and pharmacokinetics of~     PF-04447943 after single and multiple-dose administration to healthy young adult and elderly~     Japanese subjects, respectively.~   "
201983|NCT00918606|"~     An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.~   "
198857|NCT00959946|"~     This is a research study in 2 parts assessing the following parameters of the combination of~     the study drug called bosutinib, and a drug called capecitabine: the safety, how well the~     subject's body handles the study drug, and preliminary anti-tumor activity as treatment for~     different types of cancers in part 1, and breast cancer only in part 2.~      In part 1, subjects will receive bosutinib and capecitabine daily at different dose levels of~     each drug in order to determine the highest tolerated dose of the combination study~     treatment. In part 2, subjects will receive bosutinib and capecitabine at this highest~     tolerated dose to see how well the study treatment works to treat breast cancer. In addition,~     genetic research testing (research analyses involving genes and gene products) will be~     performed on biological samples from subjects.~   "
198858|NCT00959933|"~     The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200~     capsules and Rebetol 200 mg capsules in females under non-fasting conditions.~   "
198859|NCT00959920|"~     The goal of this study is to compare two clinically-relevant bladder drainage techniques.~     This is a randomized controlled trial with a single primary outcome of time to delivery. The~     results will inform clinical decisions about method of catheterization during labor.~   "
198860|NCT00959907|"~     The objective of this study is to compare the action halos of the botulinum toxins (Dysport®~     and Botox®) using two equivalence-ratios and to gather supportive information, such as more~     detailed data on the effectiveness in reduction of wrinkles and duration of action on the~     upper part of the face of both products, trough scales and photographs evaluations.~   "
198861|NCT00959894|"~     The main study is a single arm, open-label, prospective study to assess antiretroviral~     activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose~     tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a~     genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of~     the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in~     genital secretions when subjects are taking etravirine. The purpose of the metabolic~     sub-study is to learn about the effects of etravirine on body composition, as well as lipid~     and glucose levels.~   "
198862|NCT00959881|"~     This study examines the cardiac effects (effects on the heart) of administering donepezil and~     begacestat together to healthy subjects.~   "
198863|NCT00959868|"~     This is a single centre, open label, phase I dose escalation trial using a modified~     accelerated titration design. Patients with superficial bladder tumour (Ta or T1) or CIS and~     candidates for transurethral resection or muscle invasive disease (>T2) and candidates for~     radical cystectomy will be enrolled.~      OGX-427 will be given neoadjuvantly over 8 days, followed by a transurethral resection (for~     superficial disease) or radical cystectomy (for muscle invasive disease).~      Baseline Hsp27 levels will be determined from pre-treatment cytological samples from bladder~     washings and tumour biopsies performed prior to therapy.~      Post-treatment PK and PD data will be determined from TUR (for Ta, T1 tumours) or radical~     cystectomy (for T2 tumours) specimens. A recommended phase II dose will be determined from~     the toxicity, tissue pK, and percentage of Hsp27 knockdown. Effects of treatment on Hsp27~     client protein levels and apoptotic index will also be evaluated.~      Evaluation during protocol treatment will take place to assess toxicity. Assessments will~     occur on various visits as per Evaluation Schedule. Adverse event evaluation based on NCI~     CTCAEv3.0. For quality of life assessment during treatment, the EORTC QLC-BLS24 will be used~     before first treatment (day 1) and prior to surgery (TURBT or radical cystectomy). The Day 1~     QOL assessment will serve as baseline.~      After removal from protocol treatment, all subjects will be followed for toxicity related to~     study drug for 30 days.~      After the study, subjects will be followed according to standard of care. Follow-up for~     tumour recurrence or superficial tumours will be assessed every three months by cystoscopic~     examination for two years, then every six months for the next two years, and then yearly~     thereafter.~   "
198864|NCT00959855|"~     This study has been designed to capture a large group of patients who undergo pulmonary~     rehabilitation and map their progression over a 5 year time-frame.~      The outcome measures have been chosen to capture physiological, functional capacity,~     free-living activities plus admission and exacerbation rates thereby enhancing our~     understanding of the potential effects exercise and self management techniques may have on~     the disease progression.~      Pulmonary rehabilitation has not been shown to reduce inflammation; therefore, unlike acute~     exacerbation's where a decrease in inflammation indicates recovery, the exact mechanisms~     responsible for improvement during pulmonary rehabilitation are as yet unknown.~   "
198865|NCT00959842|"~     This study will build upon a previous finding that showed a triglyceride lowering effect of~     prescription omega-3 in combined therapy with statins. The proposed study will use a simple~     change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin~     therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 -~     screening (blood draw for qualification and safety); day 7 - before taking prescription~     omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking~     prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study~     will include up to 15 subjects and will utilize several different measures of lipoprotein~     structure and function. The investigators will measure functional parameters such as the~     binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The~     investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma,~     very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density~     lipoprotein (HDL).~   "
198866|NCT00959829|"~     Objectives: (1) To check music and voice message influence on vital signs and facial~     expressions of patients in physiological or induced comas; (2) To connect the existence of~     patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale.~      Method: This was a randomized controlled clinical trial with 30 patients, from two Intensive~     Care Units, being divided in 2 groups (control and experimental). Their relatives recorded a~     voice message and chose a song according to the patient's preference. The patients were~     submitted to 3 sessions for 3 consecutive days.~   "
198867|NCT00959816|"~     The objective of this study is to determine the amount of ABT-614 in the cerebral spinal~     fluid and blood after administration of a single dose and after administration of daily doses~     for 14 days in healthy volunteers.~   "
199059|NCT00957268|"~     The purpose of this study is to determine the pharmacokinetic and safety profile of~     alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.~   "
198869|NCT00959790|"~     Rationale: Consumption of vegetables is generally considered to be associated with several~     positive effects on health. Vegetables are a heterogeneous group of our diet which is rich in~     bio-actives. The vegetables contain a range of vitamins, minerals, dietary fibres and~     phytochemicals like potassium, flavonoids, carotenoids, and vitamin C. The recommended intake~     of vegetables by the Dutch Health Council is 200 grams daily (Health Council, 2006).~      Health in this project is defined as the possibility of a subject to change and adapt easily~     in response to a certain challenge. Healthy subjects show resilience in different~     physiological processes related to oxidative stress, metabolic stress, neurological stress~     and inflammatory stress. The reaction/response to a challenge might be changed when subjects~     have consumed more or less vegetables and have an improved health status. The response might~     also differentiate between subjects differing in BMI (healthy weight versus~     overweight/obese). Supplementation of vegetables will be provided in two conditions: a low~     and a high daily intake (50 versus 200 grams daily). An intervention known to have positive~     effects on health is weight loss. This will be studied in relation to health (the reaction to~     the challenge test) as well.~      A beneficial effect is present when 5% improvement of health markers is shown with vegetable~     supplementation, similar as is known from weight loss studies.~      Objective: The primary objective of the present study is to set-up a methodology to~     investigate health based on the resilience to challenge. A secondary objective is the~     effectiveness of the challenge concept with a food intervention. The vegetable~     supplementation study is a first example to test the challenge concept. Therefore, vegetable~     consumption according to the recommendations of the Dutch Health Council of 200 grams of~     vegetables daily will be studied with an exercise challenge test, to investigate the~     beneficial 'health' effects.~   "
198870|NCT00959777|"~     The safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031~     (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were~     investigated in healthy volunteers. PK/PD of filgrastim (Dong-A) following repeated dose~     delivered by SC injection were investigated in healthy volunteers. PK/PD from a single dose~     of DA-3031 and repeated dose of filgrastim (Dong-A) were compared.~   "
198871|NCT00959764|"~     The purpose of this study is to compare the effectiveness and tolerability of two~     medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal~     women with osteoporosis. Osteoporosis is the term used to describe a large group of diseases,~     which are characterized by loss of bone density, which makes the bones weaker. Osteoporosis~     often occurs in postmenopausal women.~      Calcitonin is a hormone found in the human body. Together with other substances, it regulates~     the concentration of calcium in the blood and inhibits the natural resorption of bone. Both~     medications in this study contain salmon calcitonin (sCT), because this form of calcitonin is~     more active than human calcitonin when used as a medicine.~      The calcitonin Nasal Spray used in this study is registered and available to doctors in~     United States for the treatment of osteoporosis. The medication being tested in this study is~     an oral tablet form of salmon calcitonin.~   "
198872|NCT00959751|"~     This is a a multi-center, randomized, double-blind, parallel group, and placebo controlled,~     two-arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache~     without aura. Up to 120 migraineurs will be enrolled. Approximately 60 subjects having a~     headache history of migraine without aura will complete each of the two treatment arms to~     evaluate NXN-188 600 mg or placebo.~   "
198873|NCT00959738|"~     Diverting ileostomies are created to protect a rectal anastomosis or in situations with a~     risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the~     loop is an established technique to perform a diverting loop ileostomy. However, various~     rod-less techniques have been described and are performed with similar success. The aim of~     this study is to determine, whether a modification (without rod) of the current standard~     method of protective loop ileostomy formation (with rod) could improve ileostomy specific~     morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma~     function.~   "
198874|NCT00959725|"~     The purpose of this study is to determine if intravitreal infliximab is a safe and effective~     treatment for macular edema secondary to diabetes.~   "
198875|NCT00959712|"~     This proposal is a randomized control trial using innovative interactive health technologies~     to promote and sustain walking behavior among elderly patients. The technology uses an~     Embodied Conversational Agent (ECA), a computer character that simulates face-to-face~     conversation. The trial will be block randomized by literacy status and include an intensive~     two-month, daily contact intervention via a Tablet PC ECA in the subject's home, an automated~     telephone program, and then an in-clinic, kiosk-based ECA for an additional 10 months, to~     promote maintenance of walking behavior. The study will occur in 2 phases, a pilot phase in~     which 20 subjects will be enrolled for the purpose of pre- testing the intervention and all~     data collection instruments, and a main study phase in which an additional 264 subjects will~     be enrolled.~   "
198876|NCT00959699|"~     The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034) 800~     mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b (PegIFN-2b)~     1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (RBV)~     (600 mg/day to 1400 mg/day) PO to therapy with PegIFN-2b + RBV alone in adult participants~     coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis~     C virus (HCV) genotype 1.~      Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically~     designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit~     viral replication in HCV-infected host cells. The mechanism of inhibition represents a new~     mechanism of action compared to both interferon alfa and ribavirin. Based on previous~     experience with PegIFN-2b and RBV in combination with boceprevir in the HCV-monoinfected~     population, this combination treatment is expected to provide significant benefit to the~     HIV/HCV coinfected population. Given the high unmet medical need of these participants and~     the benefit of the addition of boceprevir to PegIFN-2b/RBV, it is important to demonstrate~     the safety and efficacy of boceprevir in combination with PegIFN-2b/RBV in participants~     coinfected with HIV/HCV.~      This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in~     combination with open-label PegIFN-2b/RBV in participants coinfected with HIV and previously~     untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical~     Practice (GCP). This trial consists of two arms, one control arm (Arm 1) and one experimental~     arm (Arm 2). Participants in the control arm (Arm 1) may receive boceprevir/PegIFN-2b/RBV via~     a crossover arm.~   "
198877|NCT00959686|"~     A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell~     lymphoma BENTLY.~   "
198878|NCT00959660|"~     The purpose of this study is to examine the effects of weight loss via hypocaloric diet,~     aerobic exercise training, combined hypocaloric diet and exercise training, and attention~     control in patients with heart failure and a normal ejection fraction (HFNEF) and body mass~     index greater than or equal to 30.~   "
199539|NCT00950898|"~     The purpose of this study was to determine the acute effects of decaffeinated coffee,~     caffeinated coffee and caffeine on glucose metabolism in humans~   "
198879|NCT00959647|"~     This was a multicenter, open-label extension study. Patients who received vismodegib~     (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who~     continued to receive vismodegib at the time the parent study closed were eligible for~     continued treatment in this protocol.~   "
198880|NCT00959634|"~     This is a study to investigate the process by which ABT-126 is absorbed, distributed,~     metabolized and eliminated by the body of a healthy volunteer.~   "
198881|NCT00959621|"~     1 % of all pregnancies end in habitual/recurrent abortion. In about half of women with~     habitual abortions (HAB) hereditary or acquired (antiphospholipid antibodies) thrombophilia~     are observed. The investigators wanted to test whether antithrombotic treatment~     (Low-Molecular Weight Heparin, LMWH, ASA or both combined)would prevent these women from a~     subsequent abortion. Depending on thrombophilic status the women included in one of the three~     sub-studies: HABENOX 1 (mild, single thrombophilia), HABENOX 2 (no known thrombophilia),~     HABENOX 3 (moderate to severe thrombophilia, with combined thrombophilia or moderate to high~     titer antiphospholipid antibodies).~      Study design: Randomised placebo controlled multicenter study.~      Number of patients per study: 90 patients per group, 270 altogether.~      Timetable: Starting 2/2002, finishing 31.12.2007.~      Time frame: >37 weeks of gestation and >24, but <37 weeks of gestation (premature)~      Treatment started before 7. gw.~      HABENOX 1 and 2:~      Study groups:~      Group 1 : Enoxaparin 40 mg+ placebo, Group 2: Enoxaparin 40 +ASA 100 mg, Group 3: ASA.~      HABENOX 3:~      Study groups:~      Group 1: Enoxaparin 40 twice daily+ placebo o.d., Group 2: Enoxaparin 40 mg twice daily +ASA~     100 mg o.d.~      Primary end-points:~      Pregnancy outcome: livebirths ( ≥37 weeks of gestation), premature livebirths (≥24, but <37~     weeks of gestation)~      Secondary end-points: Bleeding complications, intrauterine growth retardation (<-2SD),~     pre-eclampsia, abruptio placentae,~      Ending: In the group of combined medication, tablets will be stopped at 36 weeks of~     gesta-tion. LMWH will be started in all patients after delivery and continued 6 weeks~     postpartum.~   "
198882|NCT00959608|"~     Think Health! A Personal Weight Management Program, or ¡Vive Saludable! Un programa~     personalizado de control de peso aims to improve the treatment of obesity in adults in the~     general population, by conducting research with men and women recruited from primary care~     medical practices. The study has a particular focus on African Americans and Latino. The~     design is randomized trial of the effectiveness of two versions of a lifestyle weight loss~     program called delivered by primary care providers (PCP) and ancillary staff at 5 clinical~     practice sites to their own patients. The two versions of the lifestyle weight loss program~     are called Basic (minimal counseling provided by PCP every four months) and Basic Plus (same~     PCP counseling plus additional counseling by specially trained ancillary practice staff~     acting as Lifestyle Coaches (LC), monthly for the first 12 months and then every other month~     for up to 2 years).~   "
198883|NCT00959595|"~     Sensory input from the foot as well as all other body parts results in activation of sensory~     cortex.~      It is well known that the cortical body map is experienced-dependant and can rapidly change~     in response to changes in activity and sensory input from the periphery [10-12]. Increased~     activity and sensory input from the hand results in expansion of the cortical hand~     representation [13-15], while decreased sensory input, for instance by anaesthesia,~     amputation or nerve injury, results in shrinkage of the cortical hand representation [16-21].~     Due to the constant ongoing cortical competition between body parts the adjacent cortical~     areas expand and take over the silent area, deprived of sensory input.~      The investigators have recently described striking examples of such rapid cortical~     re-organisations induced by selective cutaneous anaesthesia of the forearm: application of~     EMLA cream to the volar aspect of the forearm results in improved sensory functions of the~     hand [18] linked to expansion of the hand representational area in sensory cortex . In~     analogy, EMLA application to the lower leg in healthy controls results in improved sensory~     functions in the sole of the foot linked to expansion of the foot representational area in~     sensory cortex.~      To test the hypothesis that EMLA application to the lower leg of diabetic patients will~     result in improved sensory functions in the sole of the foot as well as expansion of the foot~     representation in sensory cortex. The investigators hypothesize that repeated applications of~     EMLA will result in a long lasting sensibility improvement.~   "
198884|NCT00959582|"~     This study will characterize FDG-PET (18F-Fluorodeoxyglucose-Positron Emission Tomography) as~     an early response marker in recurrent, platinum-sensitive ovarian cancer treated with~     platinum-based therapy.~   "
198885|NCT00959569|"~     This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients~     undergoing cardiac surgery to study the additive cardiac protection of this therapeutic~     strategy.~   "
198886|NCT00959556|"~     RATIONALE: Studying the genes expressed in samples of blood from patients with cancer may~     help doctors identify biomarkers related to cancer. It may also help doctors predict how~     patients will respond to chemotherapy.~      PURPOSE: This clinical trial is studying blood samples in patients with breast cancer.~   "
198887|NCT00959543|"~     MRI examination of 60 shoulders of waterpolo players (30 throwing shoulders as well as the~     opposite side) and 15 healthy probands as control group (30 shoulders of non waterpolo~     players. The correlation of MRI alteration and clinical symptomatic findings in both groups~     will be investigated. The clinical examination is performed by 2 board certified orthopedic~     surgeons and based on the Constant Murley Score.~   "
198888|NCT00959530|"~     The purpose of this study is to find the difference between patient satisfaction, masticatory~     performance and cost between two occlusal schemes for complete denture prosthodontics.~   "
198889|NCT00959517|"~     This study is an evaluation of the benefit of adding artesunate to existing first and second~     line antimalarial therapies in Pakistan.~      A placebo controlled trial was carried out to assess two potential benefits of Artesunate~     Combination Therapy (ACT): efficacy and potential for transmission reduction.~   "
198890|NCT00959504|"~     As an external validation test of the performance of the VeraCode Genotyping Test for Factor~     V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites.~     This study will assess genotyping accuracy as compared to bidirectional sequencing and~     genotyping reproducibility across variables such as user, day, and site.~   "
198891|NCT00959491|"~     The purpose of the investigators study is to evaluate the diagnostic ability of a new~     immunological fecal occult blood test in Cuban patients undergoing colonoscopy .~   "
198892|NCT00959478|"~     Carbon Monoxide (CO) exposure kills and injures thousands of children and families each year.~     Although there is growing concern about the need to increase carbon monoxide detector use,~     little is known about how best to do so, especially for low-income families. The objective of~     this research is to determine whether a brief intervention, Project Carbon Monoxide Detector~     Education (Project CODE), will increase CO detector use. For this study, parents of children,~     18 years or younger, will be randomly assigned to receive Project CODE (an educational tool~     and a CO detector) or usual care (a flyer on CO poisoning); both of which will be delivered~     in the Pediatric Emergency Department (PED) examination rooms. The use of a CO detector and~     the participant's current stage in the theory of stage-based behavior change—the Precaution~     Adoption Process Model (PAPM), will be assessed at enrollment and then again at the home~     visits which will occur two-weeks and six-months following the PED visit. The investigators~     hypothesize that parents receiving Project CODE will have working CO detectors and will be~     further along in the PAPM than parents in the control group at the two-week and six-month~     home visits. The long term goal of this research is to reduce the number of injuries and~     deaths from CO poisoning.~   "
198893|NCT00959465|"~     The purpose of the study is to obtain immunogenicity and safety data at different dose levels~     of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and~     older.~   "
198894|NCT00959452|"~     Research has shown that cognitive behavioural therapy is effective in treating hypochondria.~     However, no studies have examined the long term effect. The investigators have followed 56~     patients treated for hypochondria between 1997 and 2001 and the investigators are now doing a~     10 year follow-up (Part I). In another part of the study (Part II) the investigators compare~     the effect of 16 sessions vs. 5 sessions, with a follow-up period of at least 2 years. The~     investigators hypothesis is that the initial 1 year improvement will be sustained and that 5~     sessions will yield the same results as 16 sessions.~   "
198895|NCT00959439|"~     The purpose of this study is to demonstrate the relative bioavailability of Naproxen~     delayed-release tablets (375 mg).~   "
198896|NCT00959426|"~     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The~     primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics,~     and pharmacodynamics, of multiple oral doses of PF-04620110.~   "
198897|NCT00959413|"~     The mouth may play an important part in monitoring HIV progression. Mucosal lesions of the~     mouth are often the first sign of infection and their development in already diagnosed~     individuals indicates disease progression. In addition, saliva may provide a non-invasive way~     to track viral load. The purpose of this study is to establish standardized practices for~     examining the mouth and identifying oral mucosal lesions as well as to establish a~     correlation of viral load with HIV particles found in saliva.~   "
198898|NCT00959400|"~     Eligible patients who agree to participate will migrate from oral opioids to transdermal~     patches and be followed for four weeks. Oral morphine will be provided as pain rescue~     medication. The patients will inform the adverse events and rescue medication consumption.~     The number of Fentanest® patches will be adjusted every visit aiming to reduce the rescue~     medication consumption and adverse events to a minimum. The WHO-QOL- bref (quality of life~     questionary) will be filled before and after the use of Fentanest®. Patients showing benefit~     are eligible to a 3 weeks compassionate study.~   "
198899|NCT00959387|"~     Over the last 30 years, induction chemotherapy (IC) has become important for the management~     of patients with locally advanced HNSCC (LAHNSCC), particularly since the introduction of~     taxanes. The results reported in the TAX 323 and TAX 324 trials indicate that the TPF regimen~     (docetaxel, cisplatin and 5-fluorouracil) improves overall survival comparing with the PF~     regimen (cisplatin and 5-fluorouracil), and the TPF regimen is globally the most accepted~     induction regimen for the treatment of LAHNSCC.~      However, the TPF regimen has been associated with high toxicity rates, and patients~     frequently decline cisplatin during concurrent radiotherapy and require the use of infusion~     pumps and a central venous catheter.~      Extensive efforts are ongoing to identify alternative schemes that are less toxic than the~     TPF regimen but are as effective for LAHNSCC and safely allow the use of definitive~     concurrent treatment based on cisplatin and radiotherapy.~   "
198900|NCT00959374|"~     The objective of this study is to evaluate the use of an absorbable barbed suture as compared~     to a conventional absorbable suture when used for dermal closure during certain body~     contouring procedures.~   "
198901|NCT00959361|"~     INTRODUCTION: Studies prove that the pharmaceutical care (PC) increases the adherence to the~     antiretroviral; thus, they increase the undetectable viral load. The viral load diminishes,~     and the prevalence of undetectable viral load increases, as the levels of adherence to the~     treatment increase, being in general necessary high adhesion to reach the effectiveness~     therapeutic. Increasing the adherence levels, it increases the surviving chances and quality~     of life and diminishes the transmission risks. Studies demonstrate that the~     self-effectiveness expectation to use the medication correctly is the main predictor of~     adherence, and that the more complex the therapeutic regimen is, and the perception of side~     effects, the smaller the adherence is, highlighting the importance of preventing, identifying~     and solving the problems during the treatment with antiretroviral, problems related to the~     medication (PRM) through the PC.~      OBJECTIVES: To evaluate the effectiveness of the PC on the adherence of HIV-patients to the~     antiretroviral therapy, identify, prevent and solve PRMs during the treatment.~      METHODOLOGY: One-side randomized clinical trail controlled by non-intervention in parallel.~     332 patients randomized are included in the control and intervention groups (PC).~     Questionnaires will be applied: sociodemographic, adherence to the antiretroviral through~     self-report, smoke, BECK (depression), CAGE (problems related with alcohol consumption) of~     self-effectiveness, expectation of results and social support. Each 4 months measure of viral~     load and CD4 will be carried out. The ones from the PC group will receive a card with~     information about the medication and all the medicines will be identified by different~     colors. The follow-up will last one year according to the instructions of DADER program.~   "
198925|NCT00959049|"~     The purpose of this study is to determine the immunogenicity and safety profile of CSL~     Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus~     Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18~     years.~   "
200505|NCT00938262|"~     To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.~   "
198902|NCT00959348|"~     Inhaled steroid has been the cornerstone in the treatment of asthma, which carries a huge~     patient population worldwide including Hong Kong. In general, the safety of long-term use of~     inhaled steroid has been well documented. Yet, long-term users of such treatment carry~     increased risk of complications like cataract. In particular, the exact association of~     inhaled steroid use and development of diabetes mellitus is not known, despite a clear causal~     relationship between oral steroid use and diabetes. Therefore this epidemiology study (based~     on questionnaire and blood tests) aims to investigate the effect of inhaled corticosteroid on~     the risk of diabetes, impaired glucose tolerance and insulin resistance in adults with~     asthma. The impact of this study is expected to affect the current practice of long-term use~     of inhaled corticosteroid especially among patients with asthma.~   "
198903|NCT00959335|"~     The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50~     mg tablet and Casodex following a 50 mg dose in healthy subjects under fasting conditions.~   "
198904|NCT00959322|"~     The LenSx 550 laser system is a femtosecond laser intended for use in performing anterior~     capsulotomy during cataract surgery. The anterior capsulotomy creates a circular opening in~     the anterior surface of the capsular bag that contains the cataractous crystalline lens. The~     objective of this study is to evaluate the ability of the LenSx 550 laser to successfully~     perform anterior capsulotomy during cataract surgery.~   "
198905|NCT00959309|"~     Childhood obesity is an epidemic and increasing. There are very few effective treatments for~     obesity in children. Recent studies have shown an association between obesity and sedentary~     behaviors such as television, video viewing and playing video games ('screen time') in~     preschool aged children. A school based intervention to reduce screen time in older children~     has been effective in preventing obesity.~      The reduction of screen time may lead to the prevention of obesity and its complications in~     preschool children.~   "
198906|NCT00959296|"~     The Implantable Systems Performance Registry (ISPR) was developed to evaluate the long-term~     reliability and performance of market-released Medtronic Neuromodulation infusion and~     stimulation products.~      Completion Notice: The ISPR was created by Medtronic to monitor the performance of~     commercially available products. This registry was initially designed to track performance of~     Medtronic's implantable infusion and spinal cord stimulation systems beginning in August 2003~     and June 2004, respectively. Medtronic DBS Systems were added to the ISPR in June 2009, and~     Sacral Neuromodulation Systems in April 2010. Medtronic retired the ISPR in April 2016 and~     merged the data collected from this registry into the Product Surveillance Registry (PSR).~     Please refer to that record, Clinical Trials identifier: NCT01524276, for further~     information.~   "
198907|NCT00959283|"~     RATIONALE: Studying the genes expressed in samples of blood from patients with Down syndrome~     may help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at blood samples from newborns with Down syndrome.~   "
198908|NCT00959270|"~     The purpose of this study is to develop a cohort of volunteers that can be studied and~     followed up into the future for changes in health behaviors and development of health~     problems.~   "
198909|NCT00959257|"~     Cardiovascular disease is a major cause of morbidity and mortality worldwide. It is the~     second leading cause of death in Hong Kong. The disease burden is huge and effective control~     measures should target at prevention level. As the disease pathophysiology is linked to~     chronic low grade systemic inflammation, any therapeutics having the potential to reduce~     systemic inflammation should be vigorously explored.~      The use of long-term inhaled corticosteroid (ICS) treatment in recent 2 decades has become~     the cornerstone in the treatment of most patients with persistent asthma with reduction in~     its mortality and hospital utilization. The long term safety of ICS in adults is generally~     very high.~      Recent epidemiological studies utilizing large numbers of patients with asthma have shown~     that long term use of ICS is independently associated with a protective effect towards the~     development of myocardial infarction and cardiovascular mortality, with protective risk at~     0.35 (95%CI 0.13-0.93). This effect is possibly mediated through the reduction of low grade~     systemic inflammation as reflected by plasma hs-CRP, from systemic absorption of the ICS.~      The purpose of this study is to explore the potential protective effect of ICS on~     cardiovascular morbidities and its underlying link with systemic inflammation in Chinese~     adults with asthma compared with matched controls from the general population.~   "
198910|NCT00959244|"~     RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at urine samples from women with newly diagnosed~     breast cancer.~   "
198911|NCT00959231|"~     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor~     umbilical cord blood transplant helps stop the growth of abnormal cells. It also stops the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining abnormal cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving cyclosporine and mycophenolate~     mofetil before and after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying the side effects of donor umbilical cord blood~     transplant after cyclophosphamide, fludarabine phosphate, and total-body irradiation in~     treating patients with hematologic disease.~   "
198912|NCT00959218|"~     The purpose of this study is to determine whether Dronabinol is effective and safe in~     relieving central neuropathic pain in multiple sclerosis patients.~   "
198913|NCT00959205|"~     The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging~     compared to conventional method in patients with VT.~   "
198914|NCT00959192|"~     The purpose of this study is to assess the safety, tolerability, and immunogenicity of~     ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in~     Japan.~   "
198915|NCT00959179|"~     The purpose of this study is to evaluate the functional outcomes of resynchronization~     management and to describe the patient psychosocial characteristics (depression ad anxiety)~     and associated outcomes with electrophysiologic device therapy for chronic congestive heart~     failure.~   "
201410|NCT00926302|"~     The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra~     administered under fasting conditions to healthy adult subjects.~   "
198916|NCT00959166|"~     Subtle changes to the brain, which doctors find difficult to detect through conversation or~     examination, may occur in patients with HIV and/or hepatitis C infection. It is not currently~     known whether the brain is affected in early (or acute) hepatitis C.~      This study plans to evaluate what happens to the brain in patients with HIV and early~     hepatitis C. The investigators will be comparing 3 groups of individuals:~        -  Group 1: Individuals with HIV infection and acute (early) hepatitis C infection~        -  Group 2: Individuals with HIV infection~        -  Group 3: Healthy volunteers~      Individuals wishing to take part will complete a series of tests assessing different aspects~     of their brain including:~        -  2 brain scans using different technology:~             -  Magnetic resonance imaging (MRI) brain scan with spectroscopy~             -  CT PET brain scan~        -  A computer game test which measures brain function~        -  2 short questionnaires~      Results of these tests will be analyzed and compared between 3 groups.~   "
198917|NCT00959153|"~     A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be~     treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects~     will be followed for 14 days. If at the 14 day follow-up visit the subject continues to~     present with a stone size 4 mm or greater will have an option of retreatment or other~     intervention. If the subject consents to be retreated at this time, this subject will be~     followed up for another 14 days.~   "
198918|NCT00959140|"~     Stem cells collected from sibling donors for allogenic transplants contain various types of~     cells. The predominant immune cells are called CD3+ T cells. The amount of these T cells vary~     vastly from donor to donor. This study is to determine if standardizing the CD3+ T cell dose~     will benefit the recipient (patient). As well as to help discover if dose standardization~     causes less variation in outcomes between patients and to make transplantation more~     predictable and complications easier to manage.~   "
198919|NCT00959127|"~     This is a Phase 1 study during which patients with advanced solid tumors will receive~     investigational study drug ARRY-438162 (MEK162).~      This study has 3 parts. In the first part, patients with advanced solid tumors will receive~     increasing doses of study drug in order to achieve the highest dose of the study drug~     possible that will not cause unacceptable side effects. Approximately 30 patients from the US~     will be enrolled in Part 1. (Active, not recruiting)~      In the second part of the study, patients with advanced or metastatic biliary cancer will~     receive the best dose of study drug determined from the first part of the study and will be~     followed to see what side effects and effectiveness the study drug has, if any, in treating~     the cancer. Approximately 25 patients from the US will be enrolled in Part 2. (Active, not~     recruiting)~      In the third part of the study, patients with metastatic colorectal cancer (CRC) will receive~     the best dose of the study drug determined from the first part of the study and will be~     followed to see what side effects and effectiveness the study drug has, if any, in treating~     the cancer. Approximately 25 patients with KRAS mutation (Active, not recruiting) and 15~     patients with BRAF mutation (Active, not recruiting) from the US will be enrolled in Part 3.~   "
198920|NCT00959114|"~     A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.~   "
198921|NCT00959101|"~     This trial is conducted in Asia. The aim of this clinical trial is to investigate the~     bioequivalence of repaglinide and metformin combination tablet versus repaglinide and~     metformin as coadministered tablets after meal.~      The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic~     trial where the trial participant is randomised to one of six possible treatment periods~     (Williams design). The trial participant will receive one single dose of each trial product~     in varying order.~   "
198922|NCT00959088|"~     Early identification of tuberculosis (TB) is of particular importance in HIV-infected~     individuals, as a delay of therapy can be devastating in those with compromised immune~     systems. Diagnosis of TB in HIV is difficult, however, because 24-61% of HIV co-infected~     individuals with pulmonary TB have negative TB test results. In addition, conventional~     testing can take 6 weeks or longer and may not be available at all in many settings. This~     study is being conducted to see whether some new tests for identifying TB and for identifying~     resistance to TB drugs are at least as accurate as the current testing methods when used on~     HIV-infected individuals. The study will also assess whether the new tests can provide~     accurate results faster than the current methods.~   "
198923|NCT00959075|"~     Background: Patients with heart failure (HF) are at increased risk of developing thiamin~     deficiency (TD). Thiamin (vitamin B1) is required for the production of energy and therefore~     TD may contribute to the energy depletion commonly observed in the failing heart. Thiamin~     supplementation trials to date have shown conflicting results and therefore further studies~     to explain the impact of thiamin supplementation on HF patients with TD is necessary.~      Objective: The purpose of this study is to determine whether thiamin supplementation in an~     ambulatory cohort of patients with systolic heart failure will provide any benefit in terms~     of improved heart function, symptoms, exercise capacity, and quality of life.~      Description: Patients involved in the study will be given either thiamin supplements or a~     matching placebo (pills containing no thiamin) for 6 months. The ability of the heart to pump~     before and after the supplementation will be measured using cardiac magnetic resonance~     imaging (MRI)and/or 3D echocardiography.~      Relevance: This study will determine whether thiamin supplementation improves cardiac~     function, exercise tolerance and quality of life. Thiamin supplementation is widely~     available, inexpensive, and safe. Therefore this trial may have a major impact on the optimal~     management of the expanding population of heart failure patients.~   "
198924|NCT00959062|"~     Almost all critically ill children who are mechanically ventilated require sedation and~     analgesia. Providing effective sedation for children in the PICU requires careful balancing~     of the need for sedation with the adverse effects associated with sedative medications.~     Clonidine is often used as an adjunctive sedative and analgesic in children but a well~     designed and adequately powered randomized trial is required to test the effect of~     clonidine-based sedation. Because there are no large randomized trials of sedation related~     interventions among critically ill children there are many unknown factors. This pilot trial,~     focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a~     larger randomized controlled trial which will focus on clinically important outcomes.~   "
198926|NCT00959036|"~     The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered~     to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a~     stable dose and route of methotrexate.~   "
198927|NCT00959023|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify genes~     related to cancer.~      PURPOSE: This clinical trial is studying blood and tumor samples from men with an inherited~     risk of prostate cancer.~   "
198928|NCT00959010|"~     Essential fatty acids (EFA) deficiency has been often reported in patients with cystic~     fibrosis (CF), particularly in those homozygous for the DF508 mutation. Clinical symptoms of~     CF may be influenced by correcting EFA deficiency. Nevertheless, the value of EFA~     supplementation in CF remains controversial. Within this multicentric and international~     randomized placebo-controlled trial it will be evaluated, according to recommendations of~     Cochrane analysis, beneficial effects of an oral supplementation with polyunsaturated fatty~     acids on selected biochemical and functional outcome parameters such as inflammatory~     biomarkers, incorporation into cell membrane phospholipids, lung function, exercise~     tolerance, clinical and nutritional status and properties of transepithelial ion transport.~     The study will be undertaken in a cohort of CF patients aged over 6 years old (60 patients),~     homozygous for the DF508 mutation and treated by Azithromycine. Supplementation will be~     performed with a triglyceride source at a daily dose of 60 mg/kg of omega-3 polyunsaturated~     fatty acids (Omega 3 Premiumâ, Laboratoires Ponroy, France). Before enrolled into the trial~     and during the study, patients will undergo nutritional assessment by evaluation of total and~     fat dietary intake and overall calorie intake using a 3-days diet records and a food~     frequency questionnaire. Plasma and erythrocyte membrane EFA profiles and inflammatory~     markers will be monitored in baseline conditions, at 3, at 6 and 12 months after starting the~     treatment. Lung function will be performed at each patient visit and an exercise test will be~     done before and at the end of the treatment. Properties of ion transport will be searched by~     sweat testing before and at the end of the treatment.~   "
198929|NCT00958997|"~     Pancreatic Islet beta-cells are responsible for synthesizing and secreting appropriate~     amounts of insulin to regulate blood glucose levels. One factor in the development of~     diabetes is the loss of beta-cells. Developing treatments to prevent or restore islet~     beta-cell mass (BCM) in diabetic patients is hampered by a lack of methods for the~     non-invasive imaging of these cells. This study is designed to evaluate a radiolabeled~     compound that binds to the pancreatic islet. The investigators will test the ability of one~     promising imaging compound, 18F-9-fluoropropyl-(+)-dihydrotetrabenazine (18F-FP-DTBZ), to~     measure the amount of pancreatic islet beta-cells in patients with long-standing type-1~     diabetes and in age-weight-matched healthy control subjects.~   "
198930|NCT00958984|"~     The purpose of this study is to determine the clinical utility of non-invasive monitoring of~     Hemoglobin (Hgb) and Plethysmograph Variability Index (PVI) values during the intraoperative~     period of visceral solid organ transplantation in children. Hemoglobin values reflect~     oxygen-carrying capacity of the blood and PVI reflects fluid balance and perfusion.~   "
198931|NCT00958971|"~     The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 4~     groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and~     hormone receptor (HR) status.~   "
198932|NCT00958958|"~     Phase 1: An observational study (registry) will be conducted which will objectively document~     the ACS clinical practice in Brazilian public hospitals, and identify the important barriers~     for the evidence usage incorporation in the clinical practice.~      Phase 2: A Cluster randomized clinical trial in which public hospital will be randomized to~     receive or not a multifaceted strategy in order to increase evidence based therapy in~     clinical practice.~   "
198933|NCT00958945|"~     The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total~     hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis~     postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and~     Hematocrit which usually occurs postoperatively.~   "
198934|NCT00958932|"~     The primary aim of this project is to conduct a randomized practical clinical trial within a~     large health maintenance organization to test a telephone intervention designed to improve~     adherence to daily asthma medications and thereby improve asthma outcomes. The investigators~     hypothesize that adherence with inhaled corticosteroid medications in the TEAM intervention~     group will be greater than in the usual care group.~   "
198935|NCT00958919|"~     Endorphins are released in response to breathing difficulty and can modify the perception of~     breathlessness. In this randomized placebo-controlled trial, resistive breathing loads are~     used to provoke breathlessness in patients with chronic obstructive pulmonary disease. The~     hypothesis of the study is that intravenous (IV) administration of naloxone, a medication~     which blocks endorphin activity, will increase the perception of breathlessness experienced~     by patients while breathing through a resistance device, compared with IV administration of~     normal saline.~   "
198936|NCT00958906|"~     The purpose of this study is to determine if intravitreal infliximab is a safe and effective~     treatment for macular edema secondary to uveitis.~   "
198937|NCT00958893|"~     An open label, extension study for subjects completing the ZPU-003 Ext 1 study.~   "
198938|NCT00958880|"~     The purpose of this study is to investigate the utility of Yohimbine hydrochloride for~     facilitating fear extinction in a sample of patients with social phobia who will be treated~     with CBT.~   "
198939|NCT00958867|"~     Alzheimer's disease (AD) is a major health issue in Canada; it affects over 8% of the~     population aged over 65 years. Persons with AD have a reduced quality of life as they become~     dependent on others for activities of daily living (ADLs). This problem of loss of~     independence - functional dependence - is one focus of this grant application. It is~     projected that by 2020, Canada will have well over 10 million seniors with moderate to severe~     functional dependence. Functional dependence was the most significant contributor to an~     annual cost of dementia that had already reached $4 billion in the 1990s.~      Mild cognitive impairment (MCI) is a well-recognized risk factor for both AD and functional~     dependence. Within the broader assessment of cognitive function, the literature suggests that~     executive functioning - the ability to concentrate, to attend selectively, to plan and~     strategize - is a robust cognitive predictor of functional status in seniors. Specifically,~     Royall and colleagues demonstrated executive functioning independently explained 43% of the~     functional status in community-dwelling seniors dementia. The researchers will investigate~     executive functioning in seniors with MCI.~      Randomized trials of various exercise interventions have proven that exercise has many~     systemic benefits. Data are emerging that physical activity may improve cognition -~     specifically executive function - in healthy adults. The researchers' own pilot data suggest~     that resistance training in seniors may improve executive functioning as assessed by~     neuropsychological tests and neuro-imaging. However, at present the Cochrane Database of~     Systematic Reviews indicates there are insufficient published data to guide exercise~     prescription to prevent AD. In persons with MCI, no published studies have reported on~     whether physical activity can improve executive function, or delay its decline and thus,~     prevent or delay the onset of functional dependence (and later, dementia).~      Therefore, among seniors with MCI, the researchers will investigate whether or not specific~     exercise prescription can: 1) provide absolute or relative improvement in cognitive function,~     particularly executive function; and 2) help maintain functional independence. This will~     facilitate the development of effective exercise-based strategies for the prevention of both~     cognitive and functional decline in the large population of seniors with MCI - people at~     greatly increased risk for AD.~      The researchers' proposed research aims to ascertain whether a six-month, twice-weekly~     aerobic training (AT) program and a six-month, twice-weekly resistance training (RT) program,~     compared with a six-month, twice-weekly stretch & relax (S & R; control) program, will~     significantly improve cognition and functional status in community-dwelling women with MCI~     aged 70 years and older.~      Primary Hypothesis:~      At the end of six-month randomized trial, compared with the S & R program, both the AT and RT~     programs will significantly improve cognitive performance, as assessed by neuropsychological~     testing.~      Secondary Hypotheses:~      At the end of the six-month randomized trial, compared with the S & R program, participants~     of the AT and RT programs will:~        1. Demonstrate evidence of cortical plasticity by fMRI, such as increased activation in~          cortical regions responsible for item and relational memory; and~        2. Will significantly improve their everyday problem solving ability.~   "
198940|NCT00958854|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the~     cancer. Giving fludarabine and cyclophosphamide together with thalidomide may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide~     together with thalidomide works in treating patients with angioimmunoblastic T-cell lymphoma.~   "
198941|NCT00958841|"~     This study will assess the effectiveness and safety of pasireotide long-acting release in~     patients who have rare tumors of neuroendocrine origin.~   "
198942|NCT00958828|"~     The purpose of this study is to evaluate the performance of two daily disposable contact~     lenses in a population of daily disposable contact lens wearers.~   "
198986|NCT00958243|"~     The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425~     (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.~   "
198943|NCT00958815|"~     People with diabetes are at increased risk for atherosclerosis and have high CVD morbidity~     and mortality rates. Tools for detecting and quantifying atherosclerotic pro/regression in~     people with diabetes and other CVD risk factors lack sensitivity and specificity for~     molecular level events that occur during the early stages of atherogenesis. Inflammatory~     macrophage infiltration in the vessel endothelium is an early, molecular level proatherogenic~     event. Activated macrophages consume glucose at a high rate. Novel in vivo radiotracer PET/CT~     techniques have been developed to detect, image and quantify molecular level events like~     macrophage inflammation and glucose utilization (18FDG) in human vessels. We propose to~     develop and test this novel technique in the Center for Clinical Imaging Research (CCIR) at~     WUMS. We propose that HIV-infected people with significant CVD risk profiles are a suitable,~     unique human model for testing these novel imaging techniques. HIV-infected people taking~     anti-HIV medications develop insulin resistance, T2DM, dyslipidemia, central adiposity, and~     hypertension. HIV replicates in macrophages and represents a chronic proinflammatory~     condition. Recent data indicate that HIV+ CVD risk have greater risk for atherosclerosis and~     MI than HIV-negative people. To test feasibility, we hypothesize that: a.18FDG-PET/CT imaging~     will detect more macrophage glucose uptake and inflammation in the carotid and aorta arteries~     of HIV-infected people with CVD risk than in HIV-negative controls; b. radiotracer PET/CT~     measures of proatherogenic processes will correlate with carotid intima media thickness; a~     standard measure of carotid atherosclerotic burden. We propose to obtain pilot data that~     shows feasibility for a novel analytical approach that will expand capabilities for~     researchers interested in studying the links between diabetes, inflammation, and CVD in~     humans.~   "
198944|NCT00958802|"~     Platelet-rich plasma (PRP) has mixed growth factors such as TGF-ß1 and TGF-ß2, vascular~     epithelial growth factor (VEGF), platelet-derived growth factor (PDGF), and insulin-like~     growth factor (IGF). These growth factors appear to play an important role in wound healing~     and are assumed as promoters of tissue regeneration. Moreover, PRP was used as injectable~     scaffold seeded with chondrocytes to regenerate cartilage. In their previous study, the~     investigators concluded that growth factors in PRP can effectively react as a growth factor~     cocktail to induce human nucleus pulposus proliferation and differentiation, and also promote~     tissue-engineered nucleus pulposus formation. The investigators also have a hypothesis that~     PRP can promote tissue-engineered microtia auricular cartilage formation. TGF- ß1 exists in~     the highest concentration and is more important among all of the growth factors released from~     PRP. So TGF- ß1 can be used as the core ingredient and the indicator for applying PRP in~     these studies. The aim of this study was to compare the histological and biochemical~     character of microtia chondrocytes treated with and without PRP.~   "
198945|NCT00958789|"~     This study will be a prospective, non-randomized evaluation of the change between~     preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee~     System for a revision knee operation. The mean total Knee Society Score (for pain, motion and~     function) change is not 10% worse than, or is superior to, the expected change according to~     published revision total knee replacement data, for cases implanted with the Triathlon® TS~     Total Knee System as compared from preoperative to 2 years postoperative.~   "
198946|NCT00958776|"~     A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy~     and safety of peramivir administered intravenously in addition to standard of care compared~     to standard of care alone in adults and adolescents who are hospitalized due to serious~     influenza.~   "
198947|NCT00958763|"~     The Alcohol Use Reduction in Methadone Individuals with HCV was designed to compare three~     different types of programs for methadone maintained men and women to determine which of the~     three programs is most effective for:1) reducing alcohol consumption; 2) improving knowledge~     of and attitudes toward the disease of hepatitis and the treatment of hepatitis; 3) improving~     willingness to seek medical care for hepatitis C; 4) completing the 3 sessions on alcohol use~     reduction; 5) completing the 3 session Hepatitis A and B vaccine; and 6) determining the~     number of self-reported 12 step alcohol treatment program sessions attended.~   "
198948|NCT00958750|"~     The purpose of this study is to determine in women the risk/benefit profile and~     non-inferiority of a topical 5% Minoxidil foam formulation applied once daily for the~     treatment of androgenetic alopecia in comparison to 2% MTS used twice daily, using objective~     and subjective efficacy measures and safety assessments for a study period of 24 weeks.~   "
198949|NCT00958737|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known whether giving more than one~     drug (combination chemotherapy) is more effective when given for 3 months or 6 months in~     treating patients with colon cancer.~      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy for 3~     months to see how well it works compared with giving combination chemotherapy for 6 months in~     treating patients with stage III colon cancer.~   "
198950|NCT00958724|"~     The purposes of this study are to evaluate the safety and tolerability of neratinib in~     combination with vinorelbine at the maximum tolerated dose (MTD) determined in a previous~     study, or to determine a lower MTD of the two drugs, as well as to obtain preliminary~     information on whether the combination of the two drugs has any effect on solid tumors in~     Japanese patients.~   "
198951|NCT00958711|"~     The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and~     compare its performance with the standard of care, saline moistened gauze, for the treatment~     of diabetic foot ulcers.~   "
198952|NCT00958698|"~     This randomized clinical trial is studying two different symptom management programs to see~     how well they work compared with usual care in patients with recurrent or persistent ovarian~     cancer, fallopian tube cancer, or primary peritoneal cancer. Developing a symptom management~     plan may help relieve symptoms related to cancer or cancer treatment and help improve quality~     of life.~   "
198953|NCT00958685|"~     An enteral diet supplemented with ginger extract in acute respiratory distress syndrome~     (ARDS) patients may be beneficial for gas exchange and could decrease duration of mechanical~     ventilation and length of stay in intensive care unit (ICU).~   "
198954|NCT00958672|"~     The aim of this prospective study is to determine prevalence and characteristics of small~     intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule~     endoscopy. The investigators' findings may improve management of small intestinal involvement~     in patients with systemic sclerosis.~   "
198955|NCT00958659|"~     This research trial studies specimens from young patients with neuroblastoma. Studying the~     genes expressed in specimens from patients with cancer may help doctors identify biomarkers~     related to cancer. It may also help doctors predict how patients will respond to treatment.~   "
198956|NCT00958646|"~     The purpose of this study is to identify non-invasive biomarkers of the physiologic response~     to Osteopathic Manipulative Treatment (OMT).~   "
203746|NCT00894881|"~     The Effect of Gut Cleaning as a Preparation to Colonoscopy on resting energy expenditure~     (REE).~   "
198957|NCT00958633|"~     Patients with bipolar I disorder (BD) experience depression 3 times more frequently than~     mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of~     patients. However, no placebo-controlled trials have assessed the efficacy or safety of~     modern antidepressants in combination with mood stabilizers in the maintenance treatment of~     BD. The investigators propose a multicentre, randomized, double-blind clinical trial~     comparing mood stabilizer plus antidepressant (escitalopram or bupropion XL) to mood~     stabilizer plus placebo in the maintenance treatment of BD.~      The investigators hypothesize that in clinically representative patients with bipolar~     disorder, who respond to acute treatment with a newer antidepressant medication in~     conjunction with a mood stabilizing medication, continuing the antidepressant for 12 months~     will reduce the risk of relapse into any mood episode, including depression, mania, and~     hypomania, compared to stopping the antidepressant after 8 weeks.~   "
198958|NCT00958620|"~     Chronic Achilles tendinopathy is a painful condition with frequently unsatisfactory results~     of conservative treatment. Extracorporal Shock Wave Therapy (ESWT) has been introduced in the~     management of various soft tissue conditions. The objective of the study was to investigate~     the effect of supplementary ESWT versus placebo to conservative treatment of chronic Achilles~     tendinopathy.~   "
198959|NCT00958607|"~     About 50% of stroke survivors have limitations in their activities of daily living on return~     to the community. Family caregivers provide invaluable support to these individuals during~     their recovery and rehabilitation. Unfortunately, there is no standard clinical practice to~     prepare caregivers for this role and, as a result, many experience stress and poor health~     that can compromise stroke survivor recovery and threaten the sustainability of the care~     needed to thrive in their home. To address this gap, the investigators have developed the~     Timing it Right Stroke Family Support Program that aims to meet the evolving needs of~     caregivers. The objective of this multi-province randomized controlled trial is to determine~     if this program delivered across the stroke care continuum improves caregivers' sense of~     being supported and emotional well-being. Ultimately this program could be used by stroke~     care programs from across Canada.~   "
198960|NCT00958581|"~     Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood~     loss in the cardiac surgery literature but they have not been reported in use head-to-head in~     the orthopedic surgery literature. In a randomized, double-blind, prospective study we~     believe that TXA will be more effective than both EACA and placebo at reducing blood loss for~     corrective spinal surgery.~   "
198961|NCT00958568|"~     The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC)~     if used for a long time (47 weeks) makes patients suffering from Treatment Resistant~     Depression stable, determine if OFC is safe when used to treat patients with Treatment~     Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and~     fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression~     when treated for a long time (up to 47 weeks) and to assess the quality of life during~     treatment.~   "
198962|NCT00958555|"~     1. To establish a retrospective compilation of clinical, histopathological, treatment and~          follow-up (clinic pathological) data of previous non-small cell lung cancer (NSCLC)~          cases.~        2. To establish a prospective collection of clinic pathological information from NSCLC~          patients with corresponding blood and tissue samples~        3. To discover and validate molecular biomarkers of survival and treatment outcome in NSCLC~      One of the current difficulties in the management of lung cancer is the decision to treat and~     the type of treatment to select. Thus there is a need for additional prognostic (indicative~     of disease aggressiveness) and predictive (indicative of likely response to treatment)~     markers for lung cancer. To conduct a successful prognostic and predictive marker program,~     several factors are required, including: a comprehensive database linking clinical,~     histopathological, treatment and outcome characteristics of each case, a collection of~     samples linked to the database that is suitable for the testing of candidate markers, and a~     multi-disciplinary, interdepartmental level of expertise in the management of lung cancer.~      Objective 1:~      A review of the case records will be conducted to extract clinical, treatment and follow-up~     data~      Objective 2:~      Patients aged 21 years or more with newly diagnosed, untreated non-small cell lung cancer~     shall be approached for consent. Patients will be identified through the pathology records,~     and from the study investigators' clinic. After subject consent, baseline characteristics~     will be obtained. Follow up data on therapies received and toxicities encountered will be~     obtained. Tumor samples will be obtained only from patients with NSCLC undergoing surgery as~     part of routine clinical care. The surgical specimen will be sent to Pathology to verify the~     adequacy of the diagnostic sample as per usual practice. Blood will be collected at the~     baseline (or prior to any anti-cancer treatment) and will be sampled again at the time of~     relapse or disease progression. Collection will entail drawing 7ml blood into a Vacutainer~     CPT tube (Becton Dickinson, USA), centrifugation, extraction of a separated layer of~     mononuclear cells (MNC), labeling followed by storage below -80oC. The frequency of blood~     drawn will be about 1-5 times (7-35mls total). The number of times depends on whether the~     lung cancer relapses and in the advanced stage, how often the lung cancer relapses after~     treatment. DNA and RNA will be extracted by CSIS and stored in freezer space there. Stored~     samples will be used for investigation of prognostic and predictive markers of outcome and~     for discovery of novel molecular alterations~      Objective 3:~      Biomarker analysis of tumor and blood. Blood will be enriched for circulating tumor cells~     (CTC) using previously optimized methods (11) and DNA will be extracted from CTC and tumor~     using the Tri-Reagent (Molecular Research Center, Cincinatti, OH). DNA will be extracted from~     tumor, CTC and mononucleated cells and tested for somatic lung mutations by sequencing (2).~     Germline DNA will be analysed for genes linked to genetic risk for NSCLC and, for treatment~     toxicities, for genes related to NSCLC chemotherapy metabolic pathways.~      Tissue microarray (TMA) is a high-throughput method of analysing large numbers of~     formalin-fixed, paraffin-embedded tumor at a minimal cost and effort. To analyse the~     expression of proteins of putative relevance to EGFR function, cell proliferation,~     angiogenesis, apoptosis, metastasis, and hormonal, TMA will be utilised. PTEN and C/EBPa will~     also be analysed.~   "
198963|NCT00958542|"~     This is a prospective, multi-centre study that will be looking at two groups of males and~     females over the course of their operative treatment for cerebral palsy (CP) scoliosis and~     the years following that treatment. The first group the study will be looking at is those~     individuals who undergo surgery for CP Scoliosis. The second group will be those individuals~     who do not undergo surgical treatment for CP Scoliosis, either because the family declines~     surgery or surgery is not recommended during the course of study participation.~   "
198964|NCT00958529|"~     The intake of inulin products has been linked to multiple health benefits which has lead to~     inulin fortification in food products.~      The investigators hypothesis that doses of up to 10 grams of inulin products should be well~     tolerated and not result in a significant increase in gastrointestinal symptoms.~   "
198965|NCT00958516|"~     The purpose of this trial is to evaluate the phototoxic potential of a single application on~     healthy skin of LEO 29102 cream in different doses.~   "
198966|NCT00958503|"~     The purpose of this study is to determine if two-weeks of dosing with thiamphenicol is safe~     and is able to change the levels of certain pre-specified biomarkers in nervous tissue taken~     from the nasal passages.~   "
198967|NCT00958490|"~     Overall Objective: To evaluate the efficacy of an interventional walking program on the~     quality of life and functional status of patients with Lumbar Spinal Stenosis, post-surgery,~     using subjective (VAS, ODI, RMDQ, SF-36), and objective measures (triaxial accelerometry,~     step count, weight).~      Design and Methods: Two groups of subjects will be examined; patients diagnosed with lumbar~     spinal stenosis (LSS) that progress to surgical management, with one group of subjects~     staring on the walking program at 2 months postop, and the other group starting on the~     walking program at 3 months postop.~      Subjects who agree to participate will be assessed (assessments listed below) after the~     diagnosis preoperatively and 2 months postoperatively. One half of the group will start the~     walking program at the 2 months postop visit and be assessed again at the end of the walking~     program, the other half will be assessed again at 3 months postop and start the walking~     program at that time and be assessed again at 4 months postop. All subjects will be contacted~     by phone during their walking program to allow for questions from the subjects and to offer~     support and encouragement. Subjects will be given instructions and a daily diary to track~     steps taken each day (appendix A).~      Subjects will be recruited from the referrals to the practices of the Orthopedic and~     Neurosurgery Spine Surgeons at the Health Sciences Centre in Winnipeg. This encompasses the~     majority of new and currently managed cases in the Manitoba and Northwestern Ontario.~      Subjects will be between the ages of 18 and 90. Male and female subjects will be recruited~     into the study. All LSS patients will demonstrate intractable neurogenic claudication and~     radiographically confirmed lumbar spinal stenosis. Exclusion criteria will be any previous~     lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac~     condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal~     injury) preventing the subject from participating in regular activity and the walking~     program. Subjects participating will be required to speak English.~   "
198968|NCT00958477|"~     This study is intended to test an experimental new drug called, EMD 525797 (Study Drug). This~     drug is not yet approved for sale and has only been tested in a small number of people to~     date (prior to this study starting another research study was carried out involving 37~     healthy volunteers receiving the Study Drug). Until more is known about this Study Drug, it~     can only be used in research studies.~      This research study is planned to answer important questions about how the Study Drug is~     tolerated and how it may work in patients with prostate cancer with bone metastases.~      This is a small study which is expected to include 24 patients, and will be conducted in~     approximately 3 hospitals in Germany and 1 hospital in Brussels, Belgium. The study will last~     until the last patient has had their last study visit which is expected to be about 18 months~     in total.~   "
198969|NCT00958464|"~     The purpose of this study is to determine whether Perthes' disease has caused detectable hip~     cartilage damage in young people who have reached the healed stage of the disease.~   "
198970|NCT00958451|"~     This is an open label, single center, randomized, active comparator controlled study,~     comparing the effects of vitamin D replacement using oral ergocalciferol versus paricalcitol~     on parathyroid hormone (PTH) levels in patients with stage 3 and 4 CKD and vitamin D~     deficiency or insufficiency. The purpose of this study is to determine which of these two~     approaches is more successful.~   "
198971|NCT00958438|"~     The purpose of this clinical research study was to determine the safety and effectiveness of~     an experimental drug called rilonacept in participants with gout who are beginning~     allopurinol treatment for gout. Participants will participate in this study for approximately~     22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.~   "
198972|NCT00958425|"~     The purpose of this study is to determine the efficacy of hyaluronic acid gel injections~     compared to saline injections in improving scar quality in patients undergoing breast~     reduction surgery. Hyaluronic acid has been implicated in scarless fetal healing, and the~     investigators therefore hypothesize that injections of hyaluronic acid gel into breast~     reduction incisions will improve their appearance compared to injections of saline.~   "
198973|NCT00958412|"~     This is an extension of the phase II, three-arm, parallel design, dose-ranging,~     placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1)~     of two (2) dose levels of Proellex® was administered once-daily for four (4) months.~   "
198974|NCT00958399|"~     Research suggests dietary fiber may play a role in weight management, and fiber consumption~     is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These~     effects may be mediated by increased satiety, reduced food intake, or changes in blood levels~     of glucose, insulin, and gut hormones.~      The purpose of this study is to determine the satiety, glycemic, hormonal, and~     gastrointestinal responses of novel fiber supplements.~   "
198975|NCT00958386|"~     The purpose of the study is to evaluate the efficacy and safety of the combination of~     Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer~     refractory to irinotecan based chemotherapy.~   "
198976|NCT00958373|"~     The purpose of this pilot study is to determine the presence, frequency, and severity of~     mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.~   "
198977|NCT00958360|"~     This study will determine if the interdisciplinary team low vision rehabilitation program is~     more effective than basic low vision care provided by an optometrist working alone in~     improving visual reading ability in veterans with macular diseases and best corrected visual~     acuity of 20/50 to 20/200.~   "
198978|NCT00958347|"~     The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit~     Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system~     for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces~     of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum~     of clinical circumstances.~   "
198979|NCT00958334|"~     ZPU-003 EXT is a 2-year extension study of ZPU-003 to determine the continued safety and~     efficacy of Proellex in women who have previously completed the double-blind portion of the~     study.~   "
198980|NCT00958321|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography and computed~     tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional~     conformal radiation therapy.~      PURPOSE: This phase II trial is studying the side effects of positron emission tomography and~     computed tomography and to see how well it works in planning treatment for patients~     undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that~     cannot be removed by surgery.~      This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot~     study is investigating the technological feasibility - The Phase II study will be a 2-stage~     Phase II study~   "
198981|NCT00958308|"~     The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the~     prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated~     Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.~   "
198982|NCT00958295|"~     Acute uncomplicated bacterial cystitis is common in general practice. Cystitis is at the~     second raw of antibiotic treatment indications. It has been now recommended not to perform~     any urine culture for more than 20 years; hence, the bacterial epidemiology of acute~     uncomplicated cystitis is surprisingly relatively unknown. The available bacteriological data~     mainly describe the epidemiology of complicated urinary tract infections or upper urinary~     tract infections, but the causative bacteria and the resistance rates might differ from those~     of uncomplicated cystitis. As an example, it is unknown to what extent Staphylococcus~     saprophyticus is the causative agent of uncomplicated cystitis.~      Moreover, the urine dipstick test have been evaluated in laboratories. But their~     interpretation in current practice might not be so easy: in particular, the nitrite detection~     depends on the bacterial concentration. The nitrite detection, produced in enterobacteriaceae~     related infections might have therapeutical consequences: trométamol-fosfomycine is almost~     constantly active on enterobacteriaceae, but ineffective on staphylococci. Knowing the~     increasing prevalence of fluoroquinolone-resistant enterobacteriaceae, the use of fosfomycin~     in nitrite positive uncomplicated cystitis might preserve the susceptibility of~     fluoroquinolones during pyelonephritis.~      This study will describe:~        -  the bacterial epidemiology of acute uncomplicated cystitis in general practice,~        -  the correlation in between urine dipstick and urine culture in general practice,~        -  the prediction of enterobacterial infection by the nitrite detection, AND~        -  the antibiotics prescribed by the practitioners for uncomplicated acute cystitis.~   "
198983|NCT00958282|"~     This protocol is a 2-group double-blind placebo-controlled outpatient study investigating~     lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100~     subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and~     secondary objectives will be cocaine craving and impulsivity.~   "
198984|NCT00958269|"~     The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2~     diabetic subjects with moderate or severe renal impairment.~   "
198985|NCT00958256|"~     The goal of this clinical research study is to learn if bortezomib when given in combination~     with cyclophosphamide and rituximab can help to control mantle cell lymphoma. The safety of~     this drug combination will also continue to be studied.~   "
208189|NCT00835952|"~     Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty~   "
198987|NCT00958230|"~     The study is designed to produce early safety and performance data in a small group of~     patients requiring repair of a peripheral vascular endarterectomy (incision into an artery~     feeding the limbs which requires a patch to repair the incision after removal of an~     atherosclerotic plaque that was stopping usual blood flow to the limbs).~      Data is being collected to show the procedure is safe and allows for normal blood flow to be~     resumed.~      Data will be used to facilitate CE Mark submission.~   "
198988|NCT00958217|"~     This study will compare two different types of psychotherapy for Veterans with depression,~     addiction, and a past traumatic experience. Everyone in the study will receive 12 weeks of~     group cognitive behavioral therapy focused on depression and addiction, followed by 12 weeks~     of individual psychotherapy sessions. For the second 12 weeks, half of the people will~     receive a review of the initial therapy, and half will receive a cognitive behavioral therapy~     focused on trauma. Everyone will complete research interviews every 3 months for a total of~     18 months.~   "
198989|NCT00958204|"~     This study will investigate the additional benefits of light and ion therapy as added~     treatments to an antidepressant (fluoxetine) in subjects with major depressive disorder~     (MDD), versus treatment with fluoxetine alone. Outcomes will include depressive symptom~     rating scales and measures of quality of life, work absence and productivity, and use of~     health care services. The primary hypotheses are that, in patients with nonseasonal major~     depressive disorder (MDD) of at least moderate severity: 1) bright light therapy or negative~     ion therapy will be superior to a placebo condition in reducing symptoms of depression, and~     2) the combination of fluoxetine and either bright light or negative ion therapy is more~     effective than either monotherapy condition.~   "
198990|NCT00958191|"~     The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3~     polyethylene insert are superior to a polyethylene control group wear rate at 5 years~     postoperative. This measurement will be evaluated by comparing digitized images of serial~     radiographs obtained over a follow-up period of 5-years.~   "
198991|NCT00958178|"~     The purpose of this study is to determine whether rebreathing for a short time (a bit like~     breathing into a paper bag) will stimulate faster breathing and thus make the giving of~     Oxygen more effective.~      The hypothesis is that the investigators method (rebreathing) will be faster than the current~     method of administering Oxygen.~   "
198992|NCT00958165|"~     The purpose of this study is to determine the safety and effectiveness of the endoscopic~     ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF)~     with pulmonary vein isolation (PVI).~   "
198993|NCT00958152|"~     The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of~     the co-administration of VCH-222 and telaprevir in healthy subjects.~   "
198994|NCT00958139|"~     Hypothesis: Does treatment of lower extremity clothing with permethrin prevent Lyme disease?~      This is a double-blind, randomized clinical trial using permethrin treatment of clothing to~     prevent Lyme disease.~   "
198995|NCT00958126|"~     The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for~     eliciting an immune response to H1N1 influenza in healthy adults~   "
198996|NCT00958113|"~     The hypothesis of this project is that specific genes can be identified that contribute to~     genetic susceptibility to autoimmune thyroid disease (AITD) in different populations. The~     specific aim of this project is carry out one or more genomewide association studies (GWAS)~     to map and ultimately identify genes that confer susceptibility to AITD. AITD consists~     principally of Hashimoto's Thyroiditis (HT) and Graves' Disease (GD), characterized~     clinically generally by hypothyroidism and hyperthyroidism, respectively. Both HT and GD are~     autoimmune diseases characterized by infiltration of the thyroid by T and B cells that are~     reactive with thyroid antigens and by the production of thyroid autoantibodies (TAB). While~     there is some evidence that there may be genes specific to either GD or HT, other genes~     appear to be common to both, and some genes may furthermore be in common to susceptibility to~     other autoimmune diseases. Genes known to play a role in AITD include HLA, CTLA4,~     thyroglobulin (TG), THSR, and CD40, PTPN2, and PTPN22, several of which are also involved in~     susceptibility to other autoimmune diseases. All of these genes interact in a complex manner~     that has yet to be understood. Furthermore, it seems clear that relatively few of the genes~     involved in susceptibility to AITD have thus far been discovered.~   "
198997|NCT00958100|"~     This study aims to verify the persistent control of the virus replication at 48 weeks after~     the simplification to tenofovir + emtricitabine + raltegravir or to~     lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any~     virological failure to previous combined antiretroviral therapies needing a therapeutic~     switch for toxicity related issues or adverse events.~   "
198998|NCT00958087|"~     Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the~     formation of non-caseating granulomas in involved organs. Its cardiac involvement may be~     potentially fatal. Although endomyocardial biopsy is required for deﬁnitive diagnosis of~     cardiac sarcoidosis, it is invasive and lacks sensitivity. The specific diagnostic tool for~     cardiac sarcoidosis is far from satisfactory. Recent studies have revealed that FDG-PET with~     under fasting conditions is a useful method for identiﬁcation of cardiac sarcoidosis~     patients. However, to our knowledge, no investigations have been published with regard to FDG~     quantification for the diagnosis and management of cardiac sarcoidosis by PET.~   "
198999|NCT00958074|"~     This phase II trial studies the side effects and how well vorinostat works in treating~     patients with primary cutaneous T-cell lymphoma. Vorinostat may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth~   "
199012|NCT00957905|"~     This phase II trial is studying alvocidib and oxaliplatin to see how well they work when~     given with or without fluorouracil and leucovorin calcium in treating patients with relapsed~     or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin,~     fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving alvocidib~     together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more~     tumor cells.~   "
199060|NCT00957255|"~     Prospective, randomized, multi-center, controlled study for patients undergoing open rotator~     cuff repair. Patients are stratified based on tear size to one of three groups. Each group is~     then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.~   "
199000|NCT00958061|"~     Little is known about the long-term health and mental health status of women Vietnam~     veterans. For many of these women, the effects of this war are still present in their daily~     lives. As these women approach their mid-sixties, it is important to understand the impact of~     wartime deployment on health and mental health outcomes nearly 40 years later. The~     investigators propose to assess the prevalence of posttraumatic stress disorder (PTSD) and~     other mental and physical health conditions for women Vietnam veterans, and to explore the~     relationship between PTSD and other conditions and the Vietnam deployment experience. The~     investigators are interested in studying women Vietnam veterans who may have had direct~     exposure to traumatic events. For the first time, the investigators also want to study those~     who served in facilities near Vietnam. These women may have had similar, but less direct~     exposures. This cross-sectional study will seek to contact approximately 10,000 women for~     participation in a mailed survey, telephone interview and a review of their medical records.~     Women identified as serving in Vietnam, near Vietnam (in Asia during the Vietnam Ware) and in~     the U.S. during the Vietnam War will be identified from an established cohort and sent a~     survey on demographics, behaviors, disability, health-related quality of life, and medical~     conditions. Women agreeing to be contacted will also be interviewed by study investigators~     using the modified CIDI to ascertain current and lifetime mental health conditions (including~     PTSD) and exposure to traumatic events. A more extensive chart review will be conducted by a~     clinician to validate self-report of key medical conditions.~   "
199001|NCT00958048|"~     Specific aims:~      Aim 1. To determine the incidence of hypoventilation in Amyotrophic Lateral Sclerosis (ALS)~     patients.~      Aim 2. To identify the clinical characteristics and risk factors associated .~      Aim 3. To determine the effect of early intervention with nocturnal NIV on the prognosis of~     ALS patients.~   "
199002|NCT00958035|"~     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to~     the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in~     increasing overall eyelash prominence in self-identified African American/ethnic black~     subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).~   "
199003|NCT00958022|"~     The subjects are being asked to take part in the Phase I or Phase II portion of a research~     study of a new investigational drug, LBH589, in combination with chemotherapeutic agents,~     carboplatin with etoposide. LBH589 (made by Novartis Pharmaceuticals Corp.) is considered~     investigational because it has not been approved for commercial use in the treatment of~     cancer by the U.S. Food and Drug Administration (FDA). Etoposide and carboplatin are~     chemotherapeutic agents approved by the FDA for the treatment of for small cell lung cancer.~      LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by~     blocking certain enzymes (proteins produced by cells). LBH589 has shown effects against~     cancer in laboratory studies and in studies using animals; however, it is not known if this~     medicine will show the same activity in humans. As of May 2006, approximately 100 patients~     have received treatment with either an intravenous or capsule form of LBH589. Only the~     capsule form of LBH589 will be used in this study.~      The main goal during the Phase I portion of this research study is to find out the highest~     and safest dose of LBH589 that can be given in combination with carboplatin with etoposide in~     subjects with lung cancer without causing severe side effects. The main goal of the Phase II~     portion of this study is to find how the subject's lung cancer responds to the LBH589 in~     combination with carboplatin and etoposide at the highest and safest dose that was given in~     Phase I.~      The subject may be enrolled in either Phase I or Phase II of the trial, depending on when~     they entered the study, but they will not be enrolled in both phases.~      This study will also investigate how the subject's body processes the combination of LBH589~     and carboplatin with etoposide. To determine this, the investigators will measure the amount~     of study drug in the subject's blood. This will be done with a series of blood tests, called~     pharmacokinetic (PK) tests. Pharmacokinetics is the study of how the study drug moves through~     the body. Other purposes of this study will be to sample the subject's genetic material~     (DNA/RNA) as well as to determine biomarkers in their blood. (For some cancers, biomarkers~     are a way to measure the extent of their disease or the effects of treatment.) These samples~     will also be stored for future studies.~   "
199004|NCT00958009|"~     The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b)~     multiple domains related to subject's acceptability and satisfaction, and c) reliability of~     the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing~     multiple sclerosis (RMS).~   "
199005|NCT00957996|"~     This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and~     tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected~     influenza infection.~   "
199006|NCT00957983|"~     The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the~     headache expected during a Prostaglandin E2 infusion.~   "
199007|NCT00957970|"~     The purpose of this study is to determine if there is a difference in stress shielding and~     bone resorption of the proximal femur in two anatomical stem total hip designs.~   "
199008|NCT00957957|"~     This study will examine changes in various gut-derived hormones in obese type 2 diabetic~     patients before and after elective bariatric surgery.~   "
199009|NCT00957944|"~     The major aim of this study is to investigate and compare the drug amount delivered to the~     body after sequential application of 2 rotigotine transdermal patches from 2 different~     manufacturing sites.~   "
199010|NCT00957931|"~     The main purpose of this project is to cure patients with high risk Sickle cell disease and~     other red cell disorders including thalassemia and diamond-blackfan anemia by bone marrow~     transplantation. The patients enrolled in this study will be those who lack matched sibling~     donors and therefore have no other option but to undergo bone marrow transplantation using~     matched but unrelated bone marrow or umbilical cord blood from the national marrow donor~     program registry. Since bone marrow transplantation for these disorders using matched~     unrelated donors has two major problems i.e. engraftment, or , the process of new marrow~     being accepted and allowed to grow in the the patient; and graft-versus-host disease, or the~     process where the new marrow rejects the host or the patient, this study has been devised~     with methods to overcome these two problems and thus make transplantation from unrelated~     donors both successful in terms of engraftment and safe in terms of side effects, both acute~     and long term.~      In order to accomplish these two goals, two important things will be done. Firstly, patients~     will get three medicines which are considered reduced intensity because they are not known to~     cause the serious organ damage seen with conventional chemotherapy. These medicines, however,~     do cause intense immune suppression so these can cause increased infections. Secondly, in~     addition to transplantation of bone marrow from unrelated donors, patients will also~     transplanted with mesenchymal stromal cells derived from the bone marrow of their parents.~     Mesenchymal stromal cells are adult stem cells that are normally found in the bone marrow and~     are thought to create the right background for the blood cells to grow. They have been shown~     in many animal and human studies to improve engraftment. In addition, they have a special~     property by which they prevent and are now even considered to treat graft versus host~     disease. Therefore, by using a reduced intensity chemotherapy regimen before transplant and~     transplanting mesenchymal stromal cells, we hope to improve engraftment while at the same~     time decrease the potential for severe side effects associated with a conventional transplant~     which uses extremely high doses of chemotherapy.~   "
199011|NCT00957918|"~     The study is designed to answer the question: will nicotine at doses that do not cause~     serious side effects, show feasibility in treatment of levodopa-induced dyskinesia in~     patients with Parkinson's disease?~   "
199023|NCT00957762|"~     The purpose of this research is to evaluate different methods of measuring body composition~     (amount of fat, muscle, bone, and water in your body) and to determine relationships between~     body composition and other medical problems associated with spinal cord injury (SCI).~   "
201726|NCT00921986|"~     Biorepository of blood and or tissue samples from patients presenting with cardiac arrhythmia~     syndromes.~   "
199013|NCT00957892|"~     There is a paucity of information on whether and how the composition of formulas fed to~     infants influences their short-term feeding behaviors during the first few months of life.~     The purpose of this study is to investigate whether the composition of infant formula affects~     infants' feeding behaviors, in particular, how much formula is consumed within a given feed~     (i.e., measure of satiation) and how much time elapses after the feed until the infant~     exhibits signs of hunger (i.e., measure of satiety). The investigators will also examine the~     relationship between the composition of infant formula consumed and infant temperature,~     activity, sleep, and mothers' perceptions of infants' intake and regulatory behaviors.~   "
199014|NCT00957879|"~     Fibroblast growth factor 23 (FGF23) is a new hormone which controls phosphate and vitamin D~     levels in humans. Excess FGF23 is associated with an increased risk of death in patients with~     chronic kidney disease. In this study the investigators are investigating the effects of~     different forms of vitamin D on FGF23 levels in the blood in order to increase our~     understanding of how this important hormone works.~   "
199015|NCT00957866|"~     Background:~      According to recent estimates, the prevalence of Chronic Hepatitis C (CHC) in Canada is three~     times more common in First Nations (FN)and Metis compared to non-FN populations. Moreover,~     once infected, the progression of CHC to cirrhosis and/or hepatocellular carcinoma is greater~     in FN patients due to the increased prevalence of alcohol abuse, obesity and diabetes in this~     segment of the population.~      Research Plan:~      This research proposal consists of three parts. The objective of Part I is to document the~     response to anti-viral treatment for CHC among treatment-naïve FN and Metis and Caucasian~     (hereafter referred to as non-FN) patients residing in three urban Western Canadian centres~     (Winnipeg, Saskatoon and Regina). Demographic, clinical and response to treatment data in a~     total of 160 patients (80/group) will be collected at the above centres and transferred to~     the Section of Hepatology at the University of Manitoba for statistical analyses. In Part II,~     the applicants will document and compare the immune responses to HCV proteins throughout the~     course of therapy in FN, Metis and non-FN patients. In the final part, direct economic costs~     of CHC care in FN, Metis and non-FN patients will be ascertained and future costs predicted.~      Hypotheses:~      Part I - The rate of sustained virologic response (SVR) to treatment for CHC is higher in FN~     and Metis compared to non-FN and no Metis patients.~      Part II - The immune response to HCV proteins during anti-viral therapy for CHC is enhanced~     in FN and Metis compared to non-FN and non-Metis patients.~      Part III - The direct costs of health care utilization and delivery for CHC are similar among~     FN and Metis and non-FN and non- Metis patients.~   "
199016|NCT00957853|"~     The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery~     for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may~     cause changes in biomarkers. Biomarkers are chemical markers in the blood and/or tissue~     that may be related to a reaction to study treatment.~      The safety of the study treatments will also be studied.~   "
199017|NCT00957840|"~     Intraventricular hemorrhage and its resultant post-hemorrhagic hydrocephalus are significant~     risk factors for the development of neurodevelopmental delays in preterm infants. The purpose~     of this study is to determine 1) the incidence of progressive post-hemorrhagic ventricular~     dilatation (PHVD) in infants with severe intraventricular hemorrhage (IVH), 2) the effect of~     ventricular dilatation on brain status (cerebral oxygenation, electrical activity, and~     biomarkers of cerebral damage and repair), and 3) if using ventricular measurements, derived~     from cranial ultrasound to guide removal of cerebral-spinal fluid through an Omaya reservoir,~     will help resolve ventricular dilatation and decrease the need for ventriculo-peritoneal (VP)~     shunt insertion. The hypothesis of this research project is that, by using ventricular~     measurements to guide the frequency of CSF removal, the rate of VP shunt insertion will be~     decreased in preterm infants with severe IVH and PHVD. The investigators further hypothesize~     that cerebral injury, as measured by cerebrospinal fluid (CSF) concentration of biomarkers of~     neuronal and glial damage and inflammation, will decrease over time with resolution of PHVD.~   "
199018|NCT00957827|"~     Facial lacerations are a commonly encountered problem in the emergency department. Despite~     this, few original articles have been written concerning the management of lacerations of the~     lip which communicate with the oral cavity. Specifically, no study has been able to~     definitively show whether the use of antibiotics for these wounds decreases the infection~     rate. These cutaneous wounds are a unique type of laceration because they are continuously~     contaminated with oropharyngeal flora. Contaminated wounds result in larger, less cosmetic~     scars. Scars which involve the face have been shown to have a negative psychological impact.~     In this study, the investigators aim to determine whether the use of antibiotics decrease the~     rate of infection in lacerations of the lip which communicate with the oral cavity. Patients~     will be randomized to one of two currently practiced therapies. Patients will receive either~     cephalexin or no treatment following the repair of their through-and-through lip lacerations~     to determine whether antibiotics decrease the infection rate in these wounds.~   "
199019|NCT00957814|"~     The nutritional systematic orientations in outpatients with heart failure throughout 1 year~     in comparison to conventional treatment is estimated to lead to higher nutritional treatment~     adherence and improved nutritional status, clinical and life quality parameters.~   "
199020|NCT00957801|"~     Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level~     that compromises health and quality of life. Age-associated increases in cytokine and~     inflammatory signaling may be important contributors to this process.~      The investigators will assess the practical question of whether testosterone injection and~     gel application elicit similar responses. Resistance exercise will be used as a means of~     stimulating both inflammatory and anabolic responses in skeletal muscle. In order to assess~     the effects of testosterone on these responses, subjects will perform resistance exercise on~     two occasions separated by 7 days. The first session will be performed prior to the~     initiation of testosterone and/or medrol therapy and the second session will be performed~     after receiving therapy for 7 days.~   "
199021|NCT00957788|"~     This research study involves an experimental drug (NST_001) and a delivery system. The main~     purpose of this research study is to investigate the safety of NST-001, delivered directly to~     the inner ear for the treatment of tinnitus.~   "
199022|NCT00957775|"~     The purpose of this study is to develop and evaluate the acceptability and preliminary~     efficacy of a web-based, skills training program for adolescents with substance use~     disorders.~   "
199024|NCT00957749|"~     Molybdenum Cofactor Deficiency Type A (MoCD) is a very rare autosomal recessive disorder that~     is essentially fatal early in life. Naturally occurring cPMP is present in the body of all~     healthy normal individuals. It is processed to molybdopterin, which is further processed to~     molybdenum cofactor. Molybdenum cofactor is essential for the function of important enzymes.~      There is currently no treatment for MoCD, and affected infants develop severe neurological~     damage which often results in infant death.~      This study is the first clinical trial to investigate the potential of replacement of cPMP to~     infants with MoCD Type A. The safety, tolerability, and pharmacodynamics of daily intravenous~     administration of cPMP over 3 months will be determined.~   "
199025|NCT00957736|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to chronic~     graft-versus-host disease in patients who have undergone donor stem cell transplant.~      PURPOSE: This phase I trial is studying chronic graft-versus-host disease in patients who~     have undergone donor stem cell transplant.~   "
199026|NCT00957723|"~     The purpose of this study is to evaluate the clinical outcomes (range of motion, pain,~     function, radiographic stability, and health related quality of life) of patients receiving~     the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by~     comparing pre-operative to post-operative scores, as well as to a control group. The control~     group is the Scorpio® CR Total Knee System.~   "
199027|NCT00957710|"~     Progressive aphasia is characterized by a steady and progressive loss of language skills in~     the presence of relatively preserved memory, attention, and thinking. The aim of this study~     is to slow the progression of language decline in progressive aphasia via language therapy.~     The first goal of this study is to improve naming abilities of individuals with progressive~     aphasia. This will be accomplished by carrying out an intensive treatment program for anomia.~     The second goal is to evaluate whether this intense language treatment re-activates affected~     areas and/or connections within the language network, using functional Magnetic Resonance~     Imaging (to measure neural activity in specific brain regions) and Diffusion Tensor Imaging~     tractography (to measure the connectivity between specific brain regions). This is the first~     study on progressive aphasia addressing both treatment and imaging in the same patients.~   "
199028|NCT00957697|"~     The purpose of this study is to investigate the prevalence of characteristics of pain in a~     cohort of patients with prior stroke suspected of having central post stroke pain, identified~     through a postal questionnaire.~   "
199029|NCT00957684|"~     This was a phase III 4-part study in multiple centres. Part I was a 26-week parallel-group,~     randomised, placebo-controlled period (8 weeks single-blind placebo baseline, 2 weeks~     double-blind titration, 12 weeks maintenance, and 4 weeks tapering off). After completing the~     baseline period, patients were randomised in a 1:1:1:1 ratio to 1 of 3 ESL dose levels or to~     placebo. Part II was a 1-year open-label extension for patients who had completed Part I. The~     starting dose was 800 mg once daily and could be titrated up or down at 400-mg intervals~     between 400 and 1200 mg. Part III was an additional 1-year open-label extension for patients~     who had completed Part II, had participated in the post-Part II study extension, which~     allowed patients to continue treatment with ESL, or had continued to take ESL in a~     compassionate use program. ESL starting doses were the same as received at the end of Part~     II, during post-Part II study extension, or under compassionate use, and could be titrated up~     or down at 400-mg intervals between 400 and 1200 mg once daily. Part IV was a study extension~     to allow patients to continue ESL treatment after the end of Part III until marketing~     authorisation or discontinuation of clinical development.~   "
199030|NCT00957671|"~     Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires~     hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by~     GH stimulation testing. Moreover, abnormalities have also been established for the cortisol~     and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients~     with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle~     function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH,~     thyroid, cortisol).~   "
199031|NCT00957658|"~     The purpose of this study is to evaluate clinical and radiographic outcome data in patients~     implanted with the Accolade® TMZF® femoral stem.~   "
199032|NCT00957645|"~     Part 1: The purpose of the first part of the study is to investigate the prevalence of pain~     at stroke onset and 3 and 6 months after stroke in a consecutive cohort of stroke patients~     admitted to a stroke unit.~      Part 2: The purpose of the second part of the study is to identify patients who develop~     central post-stroke pain within the first 6 months following stroke and to try to identify~     early prognostic factors for the development of pain.~   "
199033|NCT00957619|"~     The investigators hypothecate that pentoxyfilline increase significantly the liver~     regeneration and reduces significantly ischemia and reperfusion (I/R) injury in major liver~     using aspartate aminotransferase (AST) and alanine aminotransferase (ALT) as marker of I/R~     injury.~   "
199034|NCT00957606|"~     The purpose of this study is~        -  to determine the rate of osteoporosis among patients with advanced prostate cancer.~        -  to propose an algorithm for early detection of patients with advanced prostate cancer~          who are at risk of developing osteoporosis.~   "
199035|NCT00957593|"~     The investigators propose to perform a prospective randomized control trial to compare the~     rate of cesarean delivery in women where Oxytocin (OT) is discontinued once active labor~     begins (5 cm dilation) when compared with women where OT is continued at a maintenance level~     per the usual protocol.~      One study group will follow an oxytocin protocol which is incremental until 5 cm dilation and~     then maintained at the same level throughout labor. The second arm will follow an oxytocin~     protocol also incremental, but then discontinued once the cervix is 5 cm. The primary outcome~     will be the rate of cesarean delivery between the groups. Secondary outcomes to be evaluated~     will include duration of the labor, fetal heart rate abnormalities, and frequency of uterine~     hyperstimulation, maternal and neonatal outcomes.~      As mentioned in the study proposal, the proposed experimental arm is currently not performed~     as part of the oxytocin guidelines at the investigators' institution. One study from Israel~     suggests no difference in pregnancy outcomes with the proposed use of oxytocin. Although some~     providers stop the oxytocin in active labor for their patients, this is not a commonly~     performed procedure at the investigators' institution. The investigators are not aware of~     other institutions employing the above practice.~   "
199036|NCT00957580|"~     This is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in~     blood and bone marrow cancers. The trial will be conducted in two parts:~      Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study~     drug in subjects with advanced hematological malignancies.~      Part 2: Will assess the anti-leukemic activity of the study drug in older subjects with newly~     diagnosed poor prognosis acute myeloid leukemia (AML) who are not candidates for intensive~     chemotherapy.~   "
199037|NCT00957567|"~     Early diagnosis is one of the most important factors in the survival of patients diagnosed~     with breast cancer. To aid in the early detection of breast cancer, a new technology, called~     tomosynthesis imaging is being developed. The idea behind tomosynthesis imaging is to look~     at the breast from different points of view by obtaining x-ray flat images from different~     angles while the breast does not move, and then mathematically combine these flat images into~     a three-dimensional image. The benefit of these three dimensional images is that the~     radiologist can look at the different tissues of the breast in their real positions, as~     opposed to all the tissues being flattened into a flat image, like that of a normal~     mammogram. Since tomosynthesis images of the breast show the tissues in their real position,~     the radiologist should be able to more easily find a tumor and also be able to reduce the~     number of time he or she thinks there is a tumor present when in reality there is not one~     there.~      Before this new technology can be used in the clinic routinely, it is necessary to perform a~     large number of studies to find the optimal way to use it. In this study, the investigators~     are aiming to find how thick the slices or layers representing the breast should be in the~     image when shown to the radiologist. The difference between these two thicknesses in how~     useful the images are to the radiologist could be important. The investigators are trying to~     determine if slicing the image of the breast into thicker slices will make the job of the~     radiologist easier or not when deciding to recommend or not a biopsy (laboratory analysis) of~     what the previous mammogram found. To find the answer to this question, the investigators~     will image patients with their tomosynthesis machine and look at the tomosynthesis images~     with the thin and thick slices. The radiologists that read each image will decide if they~     would have recommended the patient to get a biopsy based only in each of these images. The~     recommendations based on the images with thin slices and the recommendations based on the~     images with thick slices will be compared with what was actually recommended using the~     standard clinical tests. The investigators hope to find that the thicker slices help more~     than the thinner slices when trying to decide if biopsy is needed or not.~   "
199038|NCT00957554|"~     Primary Objective:~      To demonstrate that the antihypertensive efficacy of the fixed combination~     irbesartan/amlodipine 300/5 mg is superior to that of irbesartan 300 mg monotherapy in~     lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM)~     after 10 weeks of treatment (W10)~      Secondary Objective:~        -  To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine~          300/5 mg with that of irbesartan 300 mg monotherapy after 10 weeks of treatment (W10)~        -  To compare the antihypertensive efficacy of the fixed combination therapy~          irbesartan/amlodipine 150/5 mg with that of irbesartan 150 mg monotherapy after 5 weeks~          of treatment (W5)~        -  To examine in each treatment group the change from week 5 to week 10 in SBP and~          diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement~          (OBPM)~        -  To determine the incidence and severity of adverse events~   "
199039|NCT00957541|"~     The purpose of this study is to evaluate the performance of a new sensor-based diagnostic~     feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This~     trial will study the effectiveness of the diagnostic feature to detect heart failure events~     in medically stable, ICD-indicated, congestive heart failure patients.~   "
199040|NCT00957528|"~     The purpose of this study is to determine whether testosterone (male hormone) therapy is~     effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing~     in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body~     composition, muscle metabolism, muscle strength, and bone metabolism.~   "
199041|NCT00957502|"~     This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue~     approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be~     used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be~     implanted with product that has been aged for a specified amount of time.~   "
199042|NCT00957489|"~     Twin-Block treatment and Dynamax treatment for Class II division 1 malocclusion do not have~     different effects with regards to treatment duration, the quality of dento-occlusal outcome,~     skeletal and soft tissue profile, patient discomfort and gingival health.~   "
199043|NCT00957476|"~     Randomized, double-blind placebo controlled trial of fish oil to decrease inflammation in~     pregnancy.~   "
199044|NCT00957463|"~     The hypothesis of this study is that either obstructive sleep apnea (OSA) or cigarette~     smoking (CS) exposure would produce oxidative stress and inflammation leading to endothelial~     injury, and the combined exposure would be additive or synergistic.~   "
199045|NCT00957450|"~     Patients with cervix cancer having radiotherapy experience side-effects because the~     radiotherapy fields have to be quite large to account for tumour movement in the pelvis~     during treatment, this irradiates a lot of normal tissues. This study aims to characterize~     and model the tumour motion, as well as the motion of surrounding normal tissues, during~     treatment. By doing this, the investigators can look at ways to minimise tumour motion and~     spare more normal tissues. By tailoring the radiotherapy dose more accurately, the~     investigators will reduce the side-effects of treatment and improve local control of the~     tumour. By doing multiple magnetic resonance imaging (MRI) scans of the patients during~     treatment, the investigators can identify where the tumour and surrounding normal tissues are~     at that point in time. Collecting all the information from these scans, will allow the~     investigators to model the motion of the tumour and these pelvic organs, and investigate the~     best way to target the tumour while still sparing normal tissues.~   "
199046|NCT00957437|"~     The purpose of this study is to evaluate the pharmacokinetics of different extended-release~     formulations of AZD1305 when given as single and multiple oral doses to healthy male~     volunteers.~   "
199047|NCT00957424|"~     RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and~     nicotine replacement therapy may be useful in helping smokers stop smoking.~      PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to~     cigarettes.~   "
199048|NCT00957411|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. It is not yet known whether radiation therapy given together with cisplatin is more~     effective with or without cetuximab in treating patients with cervical cancer.~      PURPOSE: This randomized phase II trial is studying giving radiation therapy together with~     cisplatin to see how well it works compared with radiation therapy and cisplatin given~     together with cetuximab in treating patients with stage IB, stage II, or stage IIIB cervical~     cancer.~   "
199049|NCT00957398|"~     The hypothesis of the study is that the motility of the small intestine and the colon will~     alter according to the subtype of the irritable bowel syndrome (IBS) patient.~      IBS is currently classified into following subtypes:~        -  Diarrhoea-IBS (IBS-D)~        -  Constipation-IBS (IBS-C)~        -  Mixed-IBS (IBS-M)~        -  Unsubtyped-IBS (IBS-U)~      according to the Bristol scale.~      Magnetic Tracking System (MTS) is a new minimal invasive technic that allows motility studies~     of the whole human gastrointestinal tract.~      The magnetic cylindrical pill (6x15mm) is swallowed at 9 AM on day one. The recording is made~     until 4 PM and again from 8 AM until 2 PM on day two. The patient is placed in a bed and will~     be supplied with standardized food and fluid.~      The Magnetic Tracking System consists of a 4 x 4 matrix of sensors positioned with respect to~     the anatomical reference points. Before measurements, the matrix is calibrated by offsetting~     the earth's and environmental magnetic fields. During the experiment, the magnet coordinates~     are continuously monitored and transmitted to a computer for processing and storage.~     Respiratory artifacts will be filtered out. Digestive movements will then be classified as 1)~     non-propulsive or 2) propulsive and transformed into either trajectory or dynamic graphs of~     the digestive motility.~      The Magnetic Tracking System has the advantage from both radiographic and scintigraphic~     methods of conducting the tests without any radiation exposure to the patient. Preliminary~     studies have shown good concordance between the transit measured with the magnet and~     radiographic transit times.~      The investigators wish to use this method, MTS, to compare the motility of the small~     intestine and the colon in patients with IBS-D and IBS-C as well as to compare these to~     groups to MTS done on healthy volunteers under the same conditions as the IBS patients.~   "
199050|NCT00957385|"~     The purpose of this study is to determine if Revlimid will help maintain patients with acute~     myeloid leukemia in remission.~   "
199051|NCT00957372|"~     The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL)~     administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in~     patients with refractory partial epilepsy over a 12-week maintenance period.~   "
199052|NCT00957359|"~     The primary objective of this double-blind, placebo-controlled pilot study is to assess the~     efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a~     serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome~     variable being anxiety associated with cancer. Secondary outcome measures will look at the~     effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual~     distress, attitudes towards disease progression and death, quality of life, and~     spiritual/mystical states of consciousness. In addition, a secondary objective of the study~     is to determine the feasibility of administering psilocybin to this patient population, with~     regards to the following issues: safety, patient recruitment, consent for treatment, and~     retention. The duration of the proposed investigation will be long enough to administer the~     drug one time to each of thirty-two patients and to conduct follow-up assessments. This study~     is separate but similar to a recently completed study at the Los Angeles Biomedical Research~     Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although~     the outcomes measures would be similar to those used as in the Grob study, the proposed dose~     of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead~     of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up~     of 6 months duration. This study has been approved by the Bellevue Psychiatry Research~     Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through~     the issuance of an IND (77,138), the New York University School of Medicine Institutional~     Review Board (NYU IRB), the Health and Hospitals Corporation (HHC)-New York University (NYU)~     Clinical Translational Science Institute (CTSI), the NYU Bluestone Center for Clinical~     Research, and the Drug Enforcement Agency (DEA) through the issuance of a schedule I license.~      It is hypothesized that a one time experience with psilocybin will occasion dramatic shifts~     in consciousness and awareness that will lead to short-term (ie hours to days) and long-term~     (up to 6 months in this study, following the administration of the second dosing, either~     psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced~     cancer. The exact mechanism of action is unclear but based on studies done in the 60's using~     serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels,~     mood and pain were reported. However, a treatment model developed by the famous British~     psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic~     hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access~     novel dimensions of consciousness and their efficacy or lack thereof relies on whether a~     transcendent and mystical state of awareness is attained. Another possible mechanism relates~     to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,'~     where the power of suggestibility, occurring in a safe setting, allows one to transcend a~     particular state of consciousness (i.e. anxiety and depression associated with advanced~     illness) as a means to facilitate emotional discharge and to manage irreconcilable conflict.~   "
199053|NCT00957346|"~     The primary goal of this study is to determine the clinical advantage of pre-treatment with~     mifepristone in second trimester misoprostol induction abortion. This will be a randomized~     controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus~     misoprostol for second trimester (14-21 weeks' LMP) medical abortion.~   "
199054|NCT00957333|"~     This study is aimed to evaluate the relationship between ketamine abused and bladder~     dysfunction and its possible mechanisms.~   "
199055|NCT00957320|"~     The goal of this study is to find a safe dose of sirolimus that can be used with a standard~     dose of L-asparaginase. To find the safe dose, the investigators will give the first patient~     a very small dose of sirolimus (smaller than the dose used in organ transplant children) and~     the standard dose of L-asparaginase. The investigators will then look for side effects. If~     side effects develop, the investigators will decrease the dose of sirolimus. If they do not,~     the investigators will increase the dose of sirolimus in the next patient on the study. The~     investigators will continue this method until fewer than one-third of patients have a side~     effect that would require stopping the drug or changing the dose.~      The investigators plan to enroll up to 15 children with relapsed ALL. The enrolled patients~     must have recovered from other treatment before starting this study. Also, they cannot have~     severe side effects from their earlier therapy that will possibly make these drugs less safe.~      The investigators will collect information on whether these drugs help to cure the ALL, but~     the purpose will be to find a dose of sirolimus that does not cause too many side effects~     when combined with L-asparaginase. This will be explained to the families and they will sign~     a written consent. The patients will provide either verbal or written assent when~     appropriate.~   "
199056|NCT00957307|"~     Lay Summary~      The American Cancer Society has recommended that all women over the age of 40 have an annual~     mammogram for many years. This recommendation has been associated with a substantial decrease~     in breast cancer deaths. When something suspicious is seen in one of these mammograms, the~     woman is called back to the clinic for more imaging tests to better determine if that~     suspicious feature might be breast cancer. These additional imaging tests include repeated~     mammograms, magnification mammograms and/or ultrasound. Depending on what is seen in these~     images, the radiologist will provide a diagnosis that the suspicion is probably cancer,~     probably benign, or that the suspicion is a false alarm. If it is a false alarm, then the~     woman is sent home and she should come back after a year for another standard annual~     mammogram. If the diagnosis is that it is probably benign, then the woman should come back~     after 6 months so that the suspicion can be tested again. If the diagnosis is that it is~     probably cancer, the woman is recommended to have a biopsy so that the cancer can be~     confirmed. Both fortunately and unfortunately, 80% of the biopsies turn out to be false~     alarms. Although confirming that a woman does not have cancer is always a very good thing,~     having put her through the anxiety, expense, and risk of a biopsy for what turned out to be~     nothing should be avoided. Therefore, it would be desirable to reduce the number of~     unnecessary biopsies that are performed.~      Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has~     been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to~     show the breast in its real three dimensional shape. The investigators propose to use breast~     CT as a new, better tool for the radiologist to perform the diagnosis, and therefore~     hopefully result in fewer biopsies, which should decrease the false alarms. Before breast~     CT can be used clinically as a diagnostic tool, extensive testing must be performed. In this~     first step, the investigators propose to acquire breast CT images of only 10 patients that~     have been recommended to have biopsies, to see if the radiologist would have arrived at a~     different diagnosis if he/she had based his/her decision on the breast CT images. Since this~     has never been attempted before, this is an initial small study to test the feasibility of~     this method.~   "
199057|NCT00957294|"~     The metabolic syndrome (MetS) is highly prevalent in patients with schizophrenia and is a~     major risk factor of type-2 diabetes, cardiovascular disease and early death. Genetic~     factors, antipsychotic medication, sleeping disturbances and unhealthy lifestyle are possible~     causes of developing metabolic syndrome. Several studies have investigated the metabolic~     side-effects of antipsychotic medication. However it is still unanswered how unhealthy~     lifestyle, comprising physical inactivity, smoking, unhealthy dieting, and sleeping~     disturbances adds to the metabolic risk of patients with schizophrenia. The aim of this study~     is to investigate the prevalence and development of MetS in first-episode patients with~     schizophrenia and 1 year after onset of treatment. The study's main hypothesis is that~     physical inactivity, regardless of medication, is an independent risk factor for metabolic~     syndrome in patients with schizophrenia. In comparison inpatients with major depression and~     healthy controls, both matched on gender, age and level of education will be included in the~     study. It is anticipated that the study's results will provide new knowledge about the risk~     of developing metabolic syndrome in first-episode schizophrenia and how different risk~     factors contribute to this.~   "
199058|NCT00957281|"~     Asthma is a chronic airway inflammation which involves the interplay of different types of~     inflammatory cells and cytokines in the airway. The presence of systemic inflammation and~     oxidative stress in asthma suggests that it has a propensity to develop cardiovascular~     morbidity. Recent small scale studies have demonstrated that asthma severity may be~     associated with both airway and systemic inflammation. The investigators' study aims at~     linking asthma severity to airway and systemic inflammation, and subsequently to~     cardiovascular morbidity if a significant association of the aforementioned is present. The~     role of airway inflammation in contribution to systemic inflammation , and potential~     interaction between these two conditions will also be studied.~   "
199061|NCT00957242|"~     This study will test the effectiveness of warfarin in patients with IPF. Approximately 256~     patients will be randomized 1:1 to either warfarin or placebo. Patients will return at week 1~     for a safety review and every 16 weeks for 48 weeks. The primary endpoint in the study is the~     time to either death, non-bleeding/non-elective hospitalization, or a drop of greater than~     10% in forced vital capacity (FVC) from baseline.~   "
199062|NCT00957229|"~     The purpose of this study is to reduce the number of new surgically eligible BCCs by 50%~     appearing during month 3-18 of medication ingestion.~   "
199063|NCT00957216|"~     This is a Physician-sponsored pilot study, whose purpose it is determine if high-dose oral~     Coenzyme Q10 (CoQ10) is safe and tolerated in patients with sporadic forms of adult-onset~     spinocerebellar ataxias (SAOA), a group of degenerative neurological disorders affecting the~     cerebellum and pathways to and from the cerebellum, with or without additional central~     nervous system (CNS) manifestations, in the absence of family history of degenerative~     ataxias.~   "
199064|NCT00957203|"~     Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are~     eligible to enter into this long-term study. The purpose of this study is to evaluate the~     safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's~     disease treated with levodopa.~   "
199065|NCT00957190|"~     Diurnal and intervisit fluctuations in IOP are strongly associated with progression of open~     angle glaucoma and therefore need to be minimized. Control of diurnal fluctuations of IOP~     with different ocular hypotensive medications has been studied in some detail. But how do IOP~     changes contribute to progressive glaucomatous optic nerve damage? It is reasonable to assume~     that there are two principal effects of IOP changes. First, IOP fluctuations result in~     changes in the stresses and strains on the ONH which in turn result in morphological changes~     to the ONH. These morphological changes could in turn result in stretching and damage to~     axons of the ONH. Secondly, IOP fluctuations results in changes to the forces acting on the~     ONH vasculature, leading to changes in ONH vascular perfusion. These changes to perfusion~     could in turn result in relative ischemia of the ONH and consequent ONH damage.~      The investigators propose to monitor diurnal fluctuations in IOP and choroidal blood flow~     (Pulsatile Ocular Blood Flow,POBF), and intervisit ONH topographical and blood flow~     changes—ie to monitor the direct ONH consequences of IOP . Open angle glaucoma patients are~     commonly prescribed topical latanoprost as first line therapy. The EXACCT study, for which I~     was the principal investigator and which is now submitted for publication, demonstrated that~     COSOPT was an efficacious choice as second line therapy for patients not controlled on~     latanoprost monotherapy. The investigators will therefore recruit 20 OAG patients on~     latanoprost monotherapy, perform diurnal curves of IOP, as well as a.m. ONH morphology and~     ONH blood flow. Cosopt will then be added and at the next visit the same measurements will be~     repeated.~      The investigators expect that when Cosopt is added the investigators will demonstrate~     improved IOP, morphology and blood flow compared to the latanoprost baseline. Furthermore the~     investigators expect the the diurnal fluctuation of IOP and choroidal blood flow will be~     stabilized on Cosopt therapy. The implications are that adding Cosopt to latanoprost can~     stabilize not only the IOP but also the damaging consequences of IOP to the optic nerve head.~   "
199066|NCT00957177|"~     Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing~     elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device~     for self delivering opioids. Morphine consumption in the first 48 hours is documented.~      Hyperalgesia is measured by von-Frey-Filaments.~   "
199067|NCT00957164|"~     The purpose of this study is to examine the efficacy of multiple treatment options in~     addressing the co-morbidity between pain and PTSD symptoms. Recent research has suggested~     that pain and PTSD co-morbidity presents unique problems for pain and PTSD treatment, and new~     approaches are desperately needed to address this issue. To this end, the investigators hope~     to identify the efficacy of a combined pain and PTSD psychosocial treatment protocol compared~     to that of stand-alone psychosocial treatments for pain and PTSD. The primary measure for~     treatment efficacy will be treatment-related changes in measures of psychosocial and~     functional outcomes associated with chronic pain and PTSD conditions. The investigators will~     additionally measure socioeconomic outcomes including return to pre-trauma job (or a job of~     similar capacity), maintenance of active duty work at pre-trauma capacity for 6 and/or 12~     months after return, and number of healthcare appointments made between follow-ups for pain~     or PTSD treatment.~   "
199068|NCT00957151|"~     The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation~     capability of patients with chronic pancreatitis.~   "
199069|NCT00957125|"~     Patients with localized primary breast cancer including inflammatory breast cancer suitable~     for primary medical treatment and/or regional lymph node metastases receive six cycles of~     chemotherapy with epirubicin and docetaxel. Treatment evaluations are performed after the~     second, fourth and sixth cycle. In case of SD/PR after the second course, bevacizumab is~     added to the combination for the remaining four courses.~      Besides standard response evaluation clinically and by mammography and ultrasound, several~     functional imaging techniques including MR, CT-PET and contrast-enhanced ultrasound are~     investigated. Fresh tumor tissue samples from the primary tumor are collected before start,~     after two courses and in connection with surgery. The aim of the trial is to detect~     biological factors and functional imaging techniques with the ability to predict response at~     an early stage of treatment.~   "
199070|NCT00957112|"~     RATIONALE: Acupuncture may help relieve fatigue caused by breast cancer. It is not yet known~     whether acupuncture is more effective than self-acupuncture in managing fatigue in women with~     breast cancer.~      PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works~     compared with self-acupuncture in managing cancer-related fatigue in women who have received~     chemotherapy for stage I, stage II, or stage IIIA breast cancer.~   "
199081|NCT00956956|"~     The goals of this study are to evaluate the safety and tolerability of multiple ascending~     doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma~     and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to~     healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of~     PF-04455242 on serum prolactin concentration will be explored.~   "
199082|NCT00956943|"~     Unfortunately, the investigators still need to assess and identify novel ways to help people~     quit smoking. Differences between people in terms of how fast they metabolize nicotine~     influences response to transdermal nicotine patches, the most popular nicotine dependence~     treatment, and it affects plasma levels of nicotine from treatment. These studies suggest~     that fast metabolizers of nicotine may show better quit rates if they receive higher doses of~     transdermal nicotine. This preliminary study is designed to assess, for the first time,~     whether fast nicotine metabolizers show higher quit rates if given high dose transdermal~     nicotine, versus standard dose. The study findings may help to support a subsequent large~     trial to assess standard versus high dose transdermal nicotine for slow versus fast~     metabolizers of nicotine, which may lead to a more personalized approach to treating nicotine~     dependence using the nicotine patch to improve therapeutic benefits of transdermal nicotine.~   "
207916|NCT00839566|"~     Examination of CRT efficacy in patients with progressive heart failure and atrial~     fibrillation at the same time~   "
199071|NCT00957099|"~     Lay Summary~      After patients are diagnosed with breast cancer, they undergo breast magnetic resonance (MR)~     imaging to determine if the cancer is located in more than one place in the breast. Breast MR~     imaging is a good option for this test because it has very high sensitivity (catches almost~     all breast tumors). However, breast MR is slow: it takes about two minutes to acquire one~     image, and is very low resolution. The points that make up the breast MR image are around 1~     to 3 mm in size.~      Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has~     been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to~     show the breast in its real three dimensional shape. Combined with the use of special~     chemicals called iodine contrast enhancement, breast CT can provide images of both the~     anatomy and the blood flow in the breast. As opposed to breast MR, breast CT is very fast. An~     image can be taken in 10 seconds, and has very high resolution. The points in the breast CT~     image are only 0.14 mm in size. The investigators propose to use breast CT instead of breast~     MR imaging to determine if the patient's breast cancer is located in more than one place.~     This is the first time anybody has proposed to use breast CT for this, so the investigators~     aim to test the feasibility of the idea with only 6 patients.~      Since the patients will undergo breast MR as part of the standard of care, the investigators~     will be able to compare the breast CT images to the current standard, breast MR. This work~     will lay a foundation for performing this very important test before breast cancer treatment~     planning with a new, fast, high resolution imaging method, breast CT.~   "
199072|NCT00957086|"~     The aim of the study is to improve the loco-regional control rate and overall survival of~     locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that~     the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both~     epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold~     standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after~     resection of their locally advanced HNSCC will confer therapeutic advantage.~   "
199073|NCT00957073|"~     The purpose of the HOPE4HF trial is to demonstrate the safety and efficacy of the Rheos~     Baroreflex Activation Therapy System in subjects with heart failure with an EF ≥ 40% in a~     prospective, randomized trial.~   "
199074|NCT00957060|"~     Primary Objective:~      To determine the superiority of glimepiride over sitagliptin in the reduction of HbA1c after~     6 months of treatment in patients with monotherapy until the end of the trial.~      Secondary Objective:~      To evaluate the effect of glimepiride compared to sitagliptin in:~      Glucose in fasting conditions; Postprandial glucose; Percentage of patients with HbA1c < 7%~     and < 6.5%; Symptomatic Hypoglycemia; Body weight; Percentage of withdrawal and percentage of~     patients with rescue therapy; Safety (adverse events and serious adverse events,~     hypoglycemia, vital signs and laboratory results).~   "
199075|NCT00957047|"~     The primary objective of the study is to evaluate the efficacy of eslicarbazepine acetate~     once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy~     in patients with refractory partial epilepsy over a 12-week maintenance period. Patients who~     complete Part I may enter a 1-year open-label extension.~   "
199076|NCT00957034|"~     Heart failure (HF) is a complex condition resulting from structural or functional heart~     diseases that impair the ability of the heart to fill with or pump out blood. The main~     manifestations of HF are shortness of breath and tiredness which may limit the ability to~     exercise or perform simple daily physical activities such as walking. Heart disease leading~     to HF is associated with reduced muscle mass and reduced strength and low blood levels of~     testosterone; a hormone normally produced by the human (male and female) body. Recent studies~     have shown improvements of symptoms and ability to exercise in patients with heart failure~     receiving testosterone.~      This is a placebo controlled study to determine the efficacy and safety of low dose~     testosterone (300 and 450 microgram/day) delivered by a transdermal system (patch) in women~     with significant HF.~   "
199077|NCT00957021|"~     The purpose of this study is to evaluate the clinical outcomes (range of motion, pain,~     function, radiographic stability, and health related quality of life) of patients receiving~     the Triathlon® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated~     using pre-operative scores and comparing them to post-operative scores in addition to being~     compared with cases who received the Scorpio® PS implant.~   "
199078|NCT00957008|"~     Although weight loss programs are effective in the short-term, maintaining weight loss is~     more challenging. Regularly tracking and logging physical activity (PA) and diet is related~     to greater improvements in PA and diet and to greater weight loss over time. Receiving~     continuous real-time feedback regarding calories burned and calories consumed could enhance~     weight loss maintenance. This study will examine whether a device that provides such~     feedback, called the SenseWear armband, enhances weight maintenance.~      200 overweight adults aged 18 to 65 years will be randomly assigned to one of four groups:~     (1) a standard behavior change weight loss group-based program (14 group sessions over a 4~     month period followed by 6 phone calls over a 5 month period), (2) a standard behavior change~     weight loss group-based program (15 group session over a 4 month period followed by 6 phone~     calls over a 5 month period) combined with the armband, (3) the armband alone (training in~     the use of the armband and a follow up telephone call), or (4) a self-directed weight loss~     control group.~      Participants will be recruited through USC through listserv emails, flyers, and worksite~     advertisements. Interested individuals will take part in a telephone screen, an orientation,~     a run-in visit (which includes 2 weeks of PA and dietary logging), a baseline assessment, and~     a randomization visit. The intervention will then take place over a 9-month period with~     eligible participants. Participants will take part in follow-up assessments at month 4 and 9.~     Assessments at all three times will include questionnaires assessing diet, PA, psychosocial~     factors related to diet and PA, and quality of life related measures. They will also have~     their fasting blood drawn to assess lipids, glucose, and insulin, and staff will measure~     their blood pressure, waist circumference (size), skinfold, height, and weight.~   "
199079|NCT00956982|"~     The purpose of this study is to analyze the efficacy and safety of a combination therapy of~     pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients~     (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65~     years old).~   "
199080|NCT00956969|"~     This interventional, randomized controlled study seeks to test the effects of a novel~     emotional awareness and expression intervention against relaxation training or no~     intervention for college students with chronic headaches. These two interventions are~     conceptually quite distinct, as the former seeks to activate and process anger, whereas the~     latter, more commonly used technique, seeks to suppress or avoid it.~   "
199115|NCT00956501|"~     The purpose of this pilot study is to characterize changes in postural orientation and~     equilibrium in early diagnosed ALS patient. The investigators plan to cross validate the use~     of a standardized test of equilibrium (EquiTest, Computerized Dynamic Posturography - CDP) in~     early diagnosed ALS patients.~   "
199083|NCT00956930|"~     RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and~     keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking~     the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet~     known which treatment regimen is more effective in treating patients with liver cancer.~      PURPOSE: This randomized phase II trial is studying radioembolization to see how well it~     works compared with chemoembolization in treating patients with liver cancer that cannot be~     treated with Radiofrequency Ablation or removed by surgery.~   "
199084|NCT00956917|"~     The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance~     analyzer is comparable to a predicate device in measuring human body composition.~   "
199085|NCT00956904|"~     A new solution for guiding the surgeon in robot-assisted laparoscopic radical prostatectomy~     (RALP) is image-guided navigation using transrectal ultrasound (TRUS). A TRUS-guided~     intraoperative navigation system using a robotic ultrasound probe manipulator (TRUS Robot)~     has been developed. The proposed research is a pilot clinical trial of the TRUS Robot and~     three-dimensional (3-D) navigation software to test its image-guidance ability of helping the~     surgeon during RALP. This is a dual robot approach, a Tandem-RALP (T-RALP). The TRUS Robot~     allows a steady holding as well as remote manipulation of the TRUS probe. In addition, the~     TRUS Robot can track the accurate position of TRUS probe which allows 3-D reconstruction of~     the images. While the intraoperative TRUS findings will not be used in surgical decision~     making in this trial, the use of TRUS imaging during radical prostatectomy can potentially~     improve the visualization of the NVB and subsequently improve postoperative recovery of~     potency in men. In addition, the 3-D reconstruction images of the prostate gland can~     potentially provide clear and accurate guidance of surgical landmarks to the surgeon..~   "
199086|NCT00956891|"~     The study aimed to investigate the short-term efficacy and long-term prognosis of liver~     failure patients caused by hepatitis B after single transplantation with autologous marrow~     mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited~     and received the same medical treatments, among whom some patients underwent single~     transplantation with autologous MMSCs and other patients with matched age, gender and~     biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL),~     prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were in control group. A~     total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs~     suspension were slowly transfused into the liver through the proper hepatic artery by~     interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in~     translation group were compared with those in control group. In 3 ~ 48 months of follow-up,~     differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and~     mortality between two groups were compared.~   "
199087|NCT00956878|"~     Cancer pain is common in advanced cancer patients. Opioids are the mainstay of treatment in~     cancer pain. Responsiveness to and tolerability of opioids is, amongst others, determined by~     small variations in human DNA. Using blood samples from clinically well-defined cancer pain~     patients, the investigators are going to analyze single nucleotide polymorphisms (SNPs) in~     genes that are known to be involved in responsiveness to opioids and sensitivity to pain.~   "
199088|NCT00956865|"~     The purpose of this study is to determine if one of three interventions improves follow-up~     rates for screening exam participants who are instructed to have a definitive eye exam.~   "
199089|NCT00956852|"~     Lung cancer has remained as the top cancer killer in Hong Kong. Even for early resectable~     stage of lung cancer, only around 60-70% of patients can survive for 5 years after operation,~     mostly related to disease recurrence. Therefore there is urgent need for predictive~     biomarkers that can potentially help in monitoring patients for risk of disease recurrence~     after operation. Recent studies have suggested an important role of oxidative stress in the~     development of lung cancer and our preliminary data have suggested that some of the oxidative~     stress markers in blood could be predictive of response to systemic chemotherapy for lung~     cancer. Apart from potential biomarkers from blood, ongoing study has also been conducted to~     investigate the predictive role of biomarkers in exhaled breath condensate in lung cancer~     patients undergoing chemotherapy. Exhaled breath condensate can be collected simply with a~     disposable commercially available device that allows trapping of breath condensate via a~     cooling column during normal breathing for 20 minutes. Therefore this study aims at~     investigating the role of blood and exhaled breath condensate oxidative stress biomarkers~     before and after surgical lung resection for lung cancer in predicting subsequent clinical~     outcome, i.e., timing of disease recurrence. Recruited subjects will undergo interval~     sampling of blood and exhaled breath condensate, without any additional invasive~     interventions. The study subjects will be followed up for 5 years for subsequent disease~     recurrence.~   "
199090|NCT00956839|"~     The purpose of this study is to determine the efficacy of 2 different doses of intramuscular~     (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in~     the blood of patients with tropical calcific pancreatitis.~   "
199091|NCT00956826|"~     The investigators have added an additional electrode to the vacuum device for birth in which~     they can monitor the fetus during delivery.~   "
199092|NCT00956813|"~     RATIONALE: Estrogen can relieve the symptoms of menopause, but can also cause the growth of~     breast cancer cells. Flaxseed may reduce the number of hot flashes and improve mood and~     quality of life in postmenopausal women not receiving estrogen therapy.~      PURPOSE: This randomized phase III trial is studying flaxseed to see how well it works in~     treating postmenopausal women with hot flashes who have a history of breast cancer or other~     cancer or who do not wish to take estrogen therapy.~   "
199093|NCT00956800|"~     The purpose of this study is to determine if providing some care to diabetic patients~     remotely, using Accuchek 360 yields at least the same clinical results for their diabetes~     care, according to existing guidelines, as providing all care to patients in person.~   "
199094|NCT00956787|"~     The purpose of this study is to determine if AR-67 is effective in the treatment for patients~     with MDS.~   "
199116|NCT00956488|"~     The purpose of this study is to find out if supervised exercise training using a treadmill~     with partial weight support is safe and has an impact on gait and function of persons with~     Amyotrophic lateral sclerosis.~   "
199230|NCT00954993|"~     This study will evaluate the hepatic (liver) and plasma pharmacokinetics of Vaniprevir~     (MK-7009) by evaluation of ribonucleic acid (RNA) of the hepatitis C virus (HCV) in genotype~     1, HCV-infected participants.~   "
199095|NCT00956774|"~     The aim of this study is to compare the three commonly used hysterosalpingography (HSG)~     injection devices on the basis of patient pain perception, total fluoroscopic and procedural~     time, and side effects in a prospective, randomized study. An important and novel secondary~     outcome is the comparison of the quality of images obtained with these three devices. The~     investigators hypothesize that the balloon catheter and cervical vacuum cup will be less~     painful than the acorn tipped cannula and that there will be no difference in image quality~     between the three groups.~   "
199096|NCT00956761|"~     This is a trial for annual registration of the updated seasonal influenza vaccine~     formulation.~   "
199097|NCT00956748|"~     Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of~     patients do not respond to routine antibiotic or surgical treatments. The current treatment~     involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex~     (ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of~     symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that~     the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis~     media with effusion compared to the use of Ciprodex alone.~   "
199098|NCT00956735|"~     This study is investigating the effects of three different diets, including a diet with~     pistachios, on cardiovascular disease risk markers in people with type 2 diabetes.~   "
199099|NCT00956722|"~     This is an exploratory trial of Bovine Colostrum powder to decrease translocation of~     gut-derived microbial products and immune activation in HCV infection.~      The study is designed as a single-arm, open-label, before-and after exploratory trial of 10~     weeks of Bovine Colostrum Powder (BCP) to reduce translocation of intestinal microbial~     products and immune activation in patients suffering from chronic hepatitis C virus (HCV)~     infection.~      The study population will include HCV-infected (genotype 1) men and women, ≥ 18 years of age,~     not receiving anti-viral therapy at the time of enrollment and for at least the previous 3~     months. Having failed previous anti-viral therapy (non responders), HCV recurrence after 72~     weeks of therapy, developed side effects which mandated stopping anti viral therapy, or not~     considered eligible for initiation of such treatment, with a plasma HCV RNA level ≥ 1000 I.U.~   "
199100|NCT00956709|"~     Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major~     surgery of the foot. The literature does not highlight a significant difference in terms of~     onset of action between these two molecules to block the sciatic nerve [4]. Our hypothesis is~     that this lack of difference is due to the use of a neurostimulator for locating the~     injection site (indiscriminate nature of the anatomical approach to the sciatic nerve).~     Indeed, the sensitivity of neurostimulation is low compared with ultrasound [58] and~     ultrasound, for accurate visualization of the deposit of the local anesthetic around the~     nerve to improve the quality of the block and reduce the onset of action of local anesthetic~     [46, 47].~      The investigators propose to make a comparative trial between levobupivacaïne 0.5%~     ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block.~     The use of ultrasound will reduce the variability of results because the changes would be~     linked exclusively to the local anesthetic. The investigators test the hypothesis that~     levobupivacaïne gives better results in terms of onset of action than ropivacaine.~   "
199101|NCT00956696|"~     It has been estimated that 22 - 32% of people with mental retardation or learning disability~     have co-existing epilepsy. Despite such high prevalence and although there may be particular~     concerns over the effects of treatment on behaviour and cognition in this population, few~     studies have specifically addressed these concerns. Topiramate (TPM) is one of the modern~     antiepileptic drugs that has been approved for the treatment of a broad range of seizure~     types in both children and adults. There is evidence of associated improvement in behaviour~     with treatment but data is conflicting. The investigators aim to further study the effect of~     TPM on seizure control and behaviour using the Scales of Independent Behavior-Revised (SIB-R)~     which has been applied in similar patient populations and is widely adopted locally to assess~     the behaviour of people with mental retardation. This is a naturalistic, open label, single~     arm prospective study of 16-week in duration. Eligible adult patients will be initiated on~     TPM. Patients will be evaluated at baseline, end of weeks 4, 10 and 16. At each visit seizure~     control and any adverse events will be assessed. Behaviour will be assessed using SIB-R~     (Chinese version) at baseline and each study visit. At the end of the study period the~     patient's overall improvement will be rated by the investigator and the caregiver using~     global evaluation scales. Patients with improvement will be maintained on TPM after the end~     of the study period Titration schedule Topiramate will be administered orally as per usual~     clinical practice. Treatment will be initiated at 25 mg daily for 1 week, and increased in~     25- to 50-mg increments at one- to two-weekly intervals, to an initial target dose of 100 -~     200 mg daily in 2 divided doses according to each individual's response. Further dose~     adjustment can be made in response to further seizures or emergence of adverse events..~   "
199102|NCT00956683|"~     Current best practice for performance of infraclavicular block dictates the use of a~     dual-endpoint nerve stimulation technique that still only results in a 79% success rate. Use~     of an ultrasound-guided technique has the potential to significantly improve success. A~     randomized, controlled study to evaluate this area remains to be performed and is required to~     demonstrate to anesthesiologists that an ultrasound-guided approach should supersede nerve~     stimulation as the technique of choice for infraclavicular block.~   "
199103|NCT00956670|"~     This clinical trial studies lymphedema after surgery in patients with endometrial cancer,~     cervical cancer, or vulvar cancer. Collecting information over time about how often~     lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer,~     cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the~     best treatment.~   "
199117|NCT00956475|"~     RATIONALE: Collecting information about the effect of hematologic cancer and its treatment on~     quality of life may help doctors learn more about the disease and plan the best treatment.~      PURPOSE: This phase I trial is studying quality of life in younger leukemia and lymphoma~     survivors.~   "
199118|NCT00956462|"~     This study aims to evaluate the eye pressure response to non-steroidal anti-inflammatory eye~     drops as compared to steroid eye drops following glaucoma surgery.~   "
199119|NCT00956449|"~     The purpose of this study is to evaluate the antibody response to each of the three influenza~     vaccine strains included in the licensed seasonal flu vaccine, as measured by~     hemagglutination inhibition (HI) at 21 days post immunization in non−elderly and elderly~     subjects in compliance with the requirements of the current European Union (EU)~     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed~     flu vaccine (CPMP/BWP/214/96).~   "
199120|NCT00956436|"~     This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced~     hepatocellular carcinoma.~   "
199231|NCT00954980|"~     The overall objective will be to evaluate clinical predictors of outcomes in patients who~     undergo endovenous sclerotherapy for the treatment of varicose veins.~   "
199104|NCT00956657|"~     Cardiac rehabilitation (CR) programmes typically offer patients with heart disease a~     long-term programme of medical evaluation, exercise, education and counseling. National~     guidelines have recognized the positive impact that attendance at CR can have following heart~     attacks, angina and other heart problems. Patients who attend such a programme have been~     shown to have reduced health problems. Despite this, research suggests that the use of these~     services is poor and that the majority of patients eligible for these programmes do not~     continue to attend after their first class. A range of factors have been associated with~     non-adherence to CR, including psychological factors such as people's beliefs about their~     illness. For example, patients with high levels of perceived control over their illness after~     a heart attack appear to be more likely to attend CR classes than those with low levels of~     perceived control. Such findings suggest that changing patients' illness beliefs,~     specifically those associated with illness control and illness consequences, could help to~     increase adherence to CR programmes. Increased adherence to CR could improve health outcomes~     for patients with cardiac illnesses. The present study is therefore investigating the~     effectiveness of a one-session psychological intervention, based on a theory called the~     Self-Regulatory Model, in altering beliefs about illness among patients starting cardiac~     rehabilitation. Participants will be randomly assigned to a treatment or a non-treatment~     group. It is hoped that those who receive the treatment session will attend more CR classes.~   "
199105|NCT00956644|"~     Primary Objective:~        -  To demonstrate that the antihypertensive efficacy of the fixed combination~          irbesartan/amlodipine 150/5 mg is superior to that of amlodipine 5 mg monotherapy in~          lowering systolic blood pressure (SBP) as measured by home blood pressure measurement~          (HBPM) after 5 weeks of treatment (W5)~      Secondary Objective:~        -  To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine~          150/5 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment (W5)~        -  To compare the antihypertensive efficacy of the fixed combination therapy~          irbesartan/amlodipine 150/10 mg with that of amlodipine 10 mg monotherapy at the end of~          treatment (W10)~        -  To examine in each treatment group the change from week 5 to week 10 in SBP and~          diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement~          (OBPM)~        -  To determine the incidence and severity of adverse events~   "
199106|NCT00956631|"~     This is a multi-center, prospective, clinical study to assess the clinical application and~     outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal~     stenosis.~   "
199107|NCT00956605|"~     This study examines the efficacy of two computer-based training systems to teach children~     with ADHD to attend more effectively.~   "
199108|NCT00956592|"~     This study aims to evaluate the utility of a video assisted device for intubation (placement~     of a breathing tube) during surgery. This study specifically aims to compare a video assisted~     intubation with the CMAC laryngoscope to conventional devices in the setting of intubations~     predicted to be difficult.~   "
199109|NCT00956579|"~     Among the most commonly reported symptoms of autism is heightened sensitivity to sensory~     stimuli. Children and adults with autism spectrum disorders often react with aversion to~     various sounds (e.g., by covering their ears and screaming) especially at an early age. The~     investigators believe that this is because autism spectrum disorders affect how sensory input~     is experienced. Therefore, the purpose of this study is to investigate sensory processing~     abnormalities in autism spectrum disorders, or, in other words, to evaluate how and why~     children and adults with autism spectrum disorders experience external sensory information~     (vision, audition, touch) differently than healthy children and adults.~      Because some of the same abnormalities are also reported in children and adults with~     developmental language disorders such as language delay or dyslexia, the investigators are~     also interested in how that population experiences external sensory information.~   "
199110|NCT00956566|"~     The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body~     weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the~     investigators will measure cardiovascular and metabolic variables and will take blood samples~     in order to determine whether certain metabolites may predict the diet success.~   "
199111|NCT00956553|"~     This is a phase IV study to evaluate the body's immune response of participants to the~     Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with~     increased risk of cervical cancer.~   "
199112|NCT00956540|"~     The purpose of this study is to determine whether deflating the tracheal cuff in~     tracheostomized patients, during disconnections from ventilatory support along the weaning~     phase shortens the weaning time.~   "
199113|NCT00956527|"~     This is a Stage 1A/1B behavioral therapy development project with the aim of developing and~     piloting an early intervention based upon traditional martial arts for adolescents who are in~     the early stages of substance use/misuse.~      The primary aims of this study are:~      1) To develop a manualized version of an existing, typical traditional martial arts program,~     modified to target a reduction in substance use and the associated behavioral and~     psychosocial problems for adolescents in the early stages of substance use or misuse, based~     on principles derived from empirically-based prevention programs. 2) To obtain preliminary~     pilot data on recruitment feasibility, validity of assessments, and estimates of the effect~     size of the intervention in reducing substance use and improving prosocial behavioral and~     psychosocial outcomes. 3) To refine and further develop the manualized program based on pilot~     data and utilizing feedback from the initial cohort of participants, traditional martial arts~     program instructors and substance abuse treatment experts. The goals of these revisions would~     be to maximize the impact of the program on substance use and behavioral outcomes, while~     retaining the core features of a traditional martial arts program to ensure the feasibility~     of implementing, sustaining, and disseminating such a program in existing community-based~     martial arts programs. 4) To develop procedures for training interventionists (i.e., martial~     arts instructors and research assistants) and for monitoring program adherence to ensure~     fidelity. 5) To conduct a small pilot study of the refined manualized program to enable us to~     estimate the effect size of the intervention and provide information for estimating power for~     a larger randomized controlled trial should the results of this intervention prove promising~     in terms of positive impact on the primary and secondary outcome measures: decreased drug use~     and improvement in psychosocial functioning and behavioral problems (including aggression).~   "
199114|NCT00956514|"~     Transcranial magnetic stimulation (TMS) therapy has proven to lead to symptom improvement in~     many individuals with major depressive disorder (MDD), yet there is heterogeneity in outcome,~     with some patients showing robust remission and other showing minimal symptom change.~     Identifying which individuals are likely to benefit from TMS therapy early in the course of~     treatment would support continued treatment for those predicted to do well, and consideration~     of alternative treatments for others individuals. This study will test specific hypotheses~     about the relationships between early neurophysiologic changes and later clinical outcome~     with TMS treatment.~   "
199170|NCT00955786|"~     This phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe~     dose level of this drug in patients with advanced solid tumor cancers.~   "
199121|NCT00956423|"~     The purpose of this study is to compare the efficacy of two different physical activity~     regimens as complementary or alternative treatment options for the treatment of obstructive~     sleep apnea. A secondary purpose of the study is to examine the effects of these activity~     regimens on various health consequences of obstructive sleep apnea, including blood pressure,~     systemic inflammation, and daytime functioning.~   "
199122|NCT00956410|"~     This study will evaluate the safety and tolerability of repeated subcutaneous injections of~     CAD106 in patients with Alzheimer's disease.~   "
199123|NCT00956397|"~     The prevalence of functional dyspepsia (FD) is estimated to be 15% of the adult population.~     FD is commonly described as a condition of chronic abdominal discomfort localized to the~     upper abdomen. Postprandial bloating, pain, nausea, vomiting, belching, and early satiety are~     common symptoms of the FD patient. FD is defined by >12 weeks of symptoms, which need not be~     consecutive, within the preceding year consisting of a) persistent or recurrent dyspepsia and~     b) an absence of organic disease after a gastrointestinal endoscopy or x-ray series. FD is~     therefore considered a disorder of function because no mucosal pathology is seen in these~     patients, as in patients with other functional disorders such as irritable bowel syndrome~     (IBS) and fibromyalgia (FM). There is a remarkable degree of overlap among these three~     disorders. These 3 disorders share the finding of hypersensitivity and the symptom of~     postprandial bloating to suggest the possibility of a common origin.~   "
199124|NCT00956384|"~     Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast~     reconstructive option for breast cancer patients selected for immediate, skin-sparing~     mastectomy. This procedure has been demonstrated to be oncologically safe in patients with~     specific criteria for early stage breast cancer. The primary drawback, however, is that it~     requires two separate procedures under general anesthesia and multiple office visits for~     expander inflation to create the breast mound. Acellular dermal matrix has gained widespread~     acceptance for use in breast reconstruction and other areas and has the potential to provide~     support to the breast implant without tissue expansion in a one-stage procedure. The purpose~     of the study is to test this new procedure and to evaluate the impact of one-stage breast~     reconstruction using acellular dermis compared to the standard two-stage expander/implant~     technique on measures of patient satisfaction and quality of life.~   "
199125|NCT00956371|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in~     healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and~     pharmacodynamic profiles of ONO-7746.~   "
199126|NCT00956358|"~     Haemopoietic stem cell transplantation (HSCT) has become a major life-saving treatment for~     many haematological conditions, mostly malignancies.~      However, there are lots of potential complications that hinder the long-term success of HSCT,~     in which bronchiolitis obliterans syndrome (BOS) is one of such serious complications.~     Basically, BOS represents a form of graft-versus-host immunological damage of small airways~     (bronchioles), leading to progressive narrowing of small airways and thus obstructive lung~     function abnormalities. With progressive loss of lung function in BOS, patients after HSCT~     can be complicated by intractable respiratory failure that results in mortality. Up until~     now, there is still no reliable way to accurately predict or detect BOS early to allow~     pharmacological interventions.~      Therefore there is intense interest in the search for biomarkers that can help to predict the~     occurrence of BOS after HSCT. Apart from biomarkers (e.g., cytokines) in blood, there has~     been recent development in the sampling of airway lining fluid by a non-invasive method,~     i.e., collection of exhaled breath condensate (EBC). In airway diseases such as asthma or~     chronic obstructive pulmonary disease, EBC has been found to have various cytokines which can~     serve as potential biomarkers of disease activity. Since BOS is largely a small airway~     disease, it becomes logical to investigate the profile of biomarkers in EBC as predictors for~     BOS after HSCT.~      Therefore this study has been designed to look into the role of biomarkers in blood and EBC~     in early detection of BOS after HSCT.~   "
199127|NCT00956345|"~     This trial is conducted in Europe, Japan and the United States of America (USA).~      The aim of this clinical trial is to investigate the safety and pharmacokinetics (the~     determination of the concentration of the administered medication in blood over time) of~     Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with~     Haemophilia B.~   "
199128|NCT00956332|"~     The purpose of this study is to evaluate the safety and activity of two doses of~     MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential~     treatment for patients with chronic critical limb ischemia.~   "
199129|NCT00956319|"~     The purpose of the study is to investigate the efficacy and safety of zolpidem modified~     release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary~     insomnia.~   "
199130|NCT00956306|"~     This study is designed to assess the effect of hepatic impairment on the pharmacokinetics,~     safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy~     subjects.~   "
199131|NCT00956293|"~     This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks~     after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well~     tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in~     renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft~     nephropathy.~   "
199132|NCT00956280|"~     The purpose of this study is to characterize the demographic and clinical aspects, and~     describe the frequency and type of KRAS mutation in a Brazilian population sample with~     advanced non-small cell lung cancer (NSCLC).~   "
199133|NCT00956267|"~     The purpose of this study is to compare and determine the efficacy of letrozole~     administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with~     Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.~   "
199134|NCT00956254|"~     This was an open-label, single-dose study to assess the safety, tolerability, and~     absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in~     opioid-tolerant cancer subjects, with or without oral mucositis.~   "
199135|NCT00956241|"~     The objective of this study was to compare the functional and surgical results of the J-pouch~     with those of the side-to-end anastomosis and their impact on quality of life.~   "
200506|NCT00938249|"~     The purpose of the study is to determine the effect of monascus garlic fermented extract on~     serum lipid concentrations in subjects with moderately elevated serum triglyceride.~   "
199136|NCT00956228|"~     The current study involves a novel and aggressive therapeutic approach for patients' prostate~     cancer. In addition, the investigators propose to administer hormonal therapy to patients~     with an especially high risk: those with initial Gleason scores of > 6, PSA > 10 ng/ml, T3/T4~     primary tumors, and those found to be node positive (N+). The use of hormonal therapy in~     these specific settings correlates with our current standard of care. IMRT is better able to~     spare and protect normal tissues from receiving radiation than 3-D conformal RT. The~     radiotherapy would be followed by continued hormonal therapy for a total of 6 months in those~     who have one of the following Gleason 7 and PSA 10-20 and as per the previous version of this~     trial, 1 year similar to that delivered by the EORTC for higher risk patients, (those with~     initial Gleason scores of > 8, PSA > 20 ng/ml, or T3/T4 tumors). Those found to be N(+) would~     have the hormonal therapy continued indefinitely or until disease progression occurred in a~     manner analogous to the Messing et. al. series in prostatectomy patients. The goals are to~     develop and administer a program of treatment that includes the most recent developments in~     imaging, integrating data from both the CT scan and the ProstaScint scan to optimize prostate~     cancer RT. The CT scan will be used for staging and to determine the exact location of the~     entire prostate which will receive a reasonable dose of RT. The ProstaScint will be used to~     assess the spread of disease to lymph nodes as well as to determine the exact location of the~     tumor within the prostate gland. This region will then be boosted to a tumorcidal dose. The~     investigators then plan to monitor the toxicity and outcome of this treatment. The~     investigators expect that this program of radioimmunoguided IMRT will likely result in~     similar or less toxicity and increased cure rates when compared to conventional radiotherapy~     and standard IMRT programs.~   "
199137|NCT00956215|"~     The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and~     vomiting and is also approved for post-operative nausea and vomiting. The investigators'~     evaluation of it in morbidly obese patients will demonstrate its ability to control nausea~     and vomiting post-operatively in this subset of patients.~   "
199138|NCT00956202|"~     The purpose of this study is to generate data on immunogenicity and safety of the monovalent~     H1N1 vaccine in support of the development and registration.~      Primary objectives:~        -  To describe the immune response to vaccines 21 days after each vaccination in all~          participants.~        -  To describe the antibody persistence eight months after the first vaccine administration~          using HAI method, in a subset of participants who received two injections.~        -  To describe the immune response against the A/H1N1 strain using HAI method 21 days after~          a vaccination with the 2010-2011 NH seasonal TIV administered approximately 13 months~          after the first vaccination in the subset of participants who received two injections.~        -  To describe the safety profile of each vaccine in all participants.~   "
199139|NCT00956189|"~     The investigators developed an easy identification model to identify metabolic syndrome in~     patients with schizophrenia or schizoaffective disorder who received treatment of clozapine,~     olanzapine, or risperidone. The accuracy of the investigators' models showed well. In the~     study, the investigators aim to (1) to examine whether the developed identification models~     can be generalized to patients taking other antipsychotics or patients with other diagnoses;~     (2) to develop an easy risk score and validate it; (3) to switch antipsychotics to~     amisulpride or aripiprazole for those with metabolic syndrome, and compare the changes of~     metabolic parameters including adiponectin, and analyze their association with genetic~     variants, demography, and clinical variables; (4) to establish models using artificial neural~     network and statistic method to predict metabolic response after a switch to amisulpride or~     aripiprazole; (5) to investigate the effect of antipsychotics on adiponectin gene expression~     and secretion during the differentiation process of 3T3L1 adipocytes.~   "
199140|NCT00956176|"~     The goal of this clinical research study is to learn how the body absorbs and processes 1~     dose of cidofovir that is given directly into the bladder, in patients with a viral infection~     that is causing bleeding from the bladder.~      The safety of this drug dose and the investigational way it is given (directly into the~     bladder) will also be studied.~   "
199141|NCT00956163|"~     This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission~     tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging~     (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures,~     such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help~     find and diagnose bone metastases.~   "
199142|NCT00956150|"~     The adverse impact of Gulf War Syndrome (GWS) on the health of veterans and on the resources~     of the VA Healthcare System underscores the need to resolve its underlying cause. In~     response, the investigators propose to investigate the central hypothesis that gut bacteria~     may be responsible for symptoms associated with GWS. The investigators will enroll a total of~     120 patients with GWS and 90 healthy controls.~   "
199143|NCT00956137|"~     Spinal anesthesia is the technique of choice in patients undergoing total joint arthroplasty~     at Toronto Western Hospital (UHN). The most significant predictor of the ease of performance~     of spinal anesthesia is the quality of palpable surface landmarks (the spinous processes of~     the lumbar vertebrae). These surface landmarks may be absent, indistinct or distorted in many~     of the patients presenting for total joint arthroplasty. This is because of obesity, previous~     spinal surgery, scoliosis and degenerative changes of aging. The investigators have shown in~     a previous study that a pre-procedural ultrasound scan of the spine can reliably identify an~     appropriate site for needle insertion in spinal anesthesia, and that this results in a high~     success rate on the first needle insertion attempt (84% vs 61-64% in published studies). The~     investigators therefore believe that this ultrasound-assisted technique of spinal anesthesia~     is extremely useful, especially in patients with poor-quality surface landmarks. However~     there are no published randomized controlled trials to date that compare the efficacy of the~     ultrasound-assisted technique with the traditional surface landmark-guided technique of~     spinal anesthesia.~   "
199144|NCT00956124|"~     The aim of this study is to determine whether fundus autofluorescence and macular pigment~     distribution in inflammatory and diabetic macular edema are altered.~   "
199145|NCT00956111|"~     A single center, stratified, randomized and double-blind phase IV clinical trial is to be~     conducted in healthy elders (equal to or more than 61 years), adults (18-60 years),~     adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity~     of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.~   "
199146|NCT00956098|"~     This study investigated the effectiveness and safety of oltipraz therapy in treating patients~     with cirrhosis induced by chronic hepatitis type B or C.~   "
199171|NCT00955773|"~     The purpose of this study is to determine the recommended dose and regimen for the orally~     administered MEK inhibitor GSK1120212 dosed in combination with everolimus in subjects with~     solid tumors. The escalation part of the study will determine the MTD. The combination will~     be further explored in the expansion part in subjects with metastatic pancreatic cancer. In~     addition, subjects with KRAS mutant non-small cell lung cancer will be enrolled.~   "
199147|NCT00956085|"~     Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3%~     of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as~     obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only~     medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with~     SRI treatment, most patients continue to experience significant OCD symptoms, impaired~     functioning, and diminished quality of life. Recent evidence suggest that a different~     neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target~     glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from~     OCD. In this study the investigators are recruiting patients to receive the drug memantine,~     which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD~     medications they are taking.~      Open label memantine will be titrated in 5mg increments weekly to target dose of 10mg po bid~     for up to 6 weeks. Memantine will be continued to 12 weeks in those with treatment~     response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV~     ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks~     of memantine).~   "
199148|NCT00956072|"~     RATIONALE: Surgery may remove residual disease in patients with gastrointestinal stromal~     tumor that is responding to imatinib mesylate. It is not yet known whether surgery is more~     effective than continued imatinib mesylate in treating patients with metastatic~     gastrointestinal stromal tumor.~      PURPOSE: This randomized phase III trial is studying giving imatinib mesylate therapy~     together with surgery to see how well it works compared with imatinib mesylate alone in~     treating patients with metastatic gastrointestinal stromal tumor that is responding to~     imatinib mesylate.~   "
199149|NCT00956059|"~     The aim of this clinical trial is to determine the effect and security of low-dose Prednisone~     Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis.~   "
199150|NCT00956046|"~     The purpose of this study is to generate data on immunogenicity and safety of the monovalent~     H1N1 vaccine in support of the development and registration.~      Primary objectives:~        -  To describe the immune response to vaccines 21 days after each vaccination in all~          participants.~        -  To describe the antibody persistence eight months after the first vaccine administration~          using hemagglutination inhibition (HAI) method in a subset of participants who received~          two half-doses of either formulation 1 or 2.~        -  To describe the immune response against the A/H1N1 strain using the HAI method 21 days~          after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV)~          administered 13 months after the first vaccination in a subset of subjects who received~          two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as~          primary series.~        -  To describe the safety profile of each vaccine in all participants.~   "
199151|NCT00956033|"~     Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple~     myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these~     drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose~     and quantify using conventional electromyography. Determining intra-epidermal nerve fiber~     density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more~     sensitive and more specific ancillary investigation to establish the diagnosis of small fiber~     neuropathy. In this study the investigators aim to establish the sensitivity of IENFD~     measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.~   "
199152|NCT00956020|"~     Autologous platelet rich fibrin matrix will release growth factors which could increase the~     production of dermal proteins or affect the vascularity and status of neighboring tissues.~     This study is designed to evaluate the histologic and biochemical effect of injection of~     platelet rich fibrin matrix into the skin.~   "
199153|NCT00956007|"~     RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to~     help focus thin beams of radiation directly on the tumor, and giving radiation therapy in~     higher doses over a shorter period of time, may kill more tumor cells and have fewer side~     effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. It is not yet known whether radiation~     therapy is more effective when given alone or together with cetuximab in treating patients~     with head and neck cancer that has been removed by surgery.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared with radiation therapy given together with cetuximab in treating patients who~     have undergone surgery for locally advanced head and neck cancer.~   "
199154|NCT00955994|"~     The treatment of acute pain in patients with irritable bowel symptoms is suboptimal. This is~     a placebo controlled study of the on demand treatment of pain experienced over a 4 week~     period in patients with irritable bowel syndrome. Patients will record the severity of pain~     when they take the study medication and two hours later.~   "
199155|NCT00955981|"~     To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28~     days of dosing by treatment group.~   "
199156|NCT00955968|"~     This study was a randomized strategy trial conducted among women who received highly active~     antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child~     transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their~     own health. The study was designed to determine whether continuation of HAART after delivery~     or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and~     re-initiation of HAART when protocol specified criteria were met.~   "
199157|NCT00955955|"~     The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin) is safe and effective~     in relieving depression when it is added to standard kinds of antidepressants called~     serotonin reuptake inhibitors (SSRIs).~   "
199158|NCT00955942|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Flaxseed may help~     protect normal cells from the side effects of radiation therapy.~      PURPOSE: This randomized phase I trial is studying the side effects of flaxseed supplement in~     treating patients with locally advanced or metastatic non-small cell lung cancer undergoing~     chemotherapy and radiation therapy.~   "
199322|NCT00953771|"~     The purpose of the study is to find out if administration of danazol with plasma exchange and~     corticosteroids will reduce the number of plasma exchanges required to control Thrombotic~     Thrombocytopenic Purpura (TTP).~   "
199159|NCT00955929|"~     When a bilateral nerve-sparing radical prostatectomy (RP) is performed, recovery of erectile~     function (rigid erections) is reported for up to 80% of patients, who are less than 60 years~     old. Erectile function recovery is also impacted by patient age, erectile function before~     surgery, and the length of time after surgery.~      Current evidence from studies suggests that developing erections is important, however, these~     studies have been small, and the evidence is not definite. Animal studies suggest that~     erection medication (Viagra, Levitra, Cialis) may protect erection tissue, even in the~     absence of erections. However, the correct treatment plan is unknown. For example, how often~     does a man need to take sildenafil (Viagra®) to protect his erectile function or to maximize~     his erectile function recovery? Is only using erection medication enough for erectile~     function recovery? Would penile injections, which almost ensure production of an erection, be~     better than using sildenafil (Viagra®), or might a combination be even better at helping~     recovery of erections? These are types of questions this study might answer.~   "
199160|NCT00955916|"~     The purpose of the study is to find out what effects (good and bad) Gleevec® (Imatinib~     mesylate) combined with chemotherapy has on participants and their acute myeloid leukemia.~   "
199161|NCT00955903|"~     The investigators want to determine if the benefits of weight loss outweigh the potential~     risk in a group of older adults. The investigators will test the hypothesis that changes in~     diet composition alone or in conjunction with weight loss will have a significant effect on~     fat stores, and as a result, improve cardiometabolic risk factors and functional status in~     adults 65 and older.~   "
199162|NCT00955890|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the~     side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor~     cells and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Radiation therapy uses high-energy x-rays to damage tumor cells. CTnT/cTnI/ANP/BNP~     were proved to be used as a biomarker of drug related cardiotoxicity. There are excellent~     correlations between the total cumulative dose of doxorubicin, the severity of the resulting~     cardiomyopathy, and the level of serum troponin-T.~   "
199163|NCT00955877|"~     The purpose of this proposal is to improve the investigators' current Selective Dorsal~     Rhizotomy (SDR) analgesia protocol by eliminating or minimizing the use of fentanyl in the~     post-operative period.~      Children undergoing SDR for spastic cerebral palsy have significant post-operative pain. The~     procedure requires dissection of the lumbar back musculature and removal of the L1 lamina~     (the bony posterior part of the vertebra). The majority of the operation is intradural, and a~     water-tight dural closure at the termination of the operation is critical in order to prevent~     leakage of cerebrospinal fluid (CSF) from the wound. In fact, these children must remain flat~     on their back for 48 hours to allow the dural incision to heal prior to mobilization. Thus,~     adequate pain control is essential not only for patient comfort, but also to prevent~     agitation and additional stress on the dural closure.~      Currently, the investigators' patients undergoing SDR are treated for 48 hours with scheduled~     intravenous (IV) narcotic (continuous fentanyl infusion at 0.5-2.0 μg/kg/hour) in addition to~     the sedative/muscle relaxant Valium (0.2 mg/kg IV every 4 hours for 24 hours, then every 6~     hours for 24 hours). The IV fentanyl, and to a lesser degree Valium, carries a real risk of~     hypotension and respiratory depression and requires frequent dose adjustments to achieve~     adequate analgesia.~      By improving the current SDR analgesia protocol, the investigators hope to maximize patient~     safety and comfort while maintaining the effectiveness of the operation by minimizing the~     risk of CSF leak.~   "
199164|NCT00955864|"~     Background:~        -  The uterine cervix is composed of muscle and collagen, which change as women age and~          under hormonal influences like puberty, pregnancy, and menopause. Yet even though~          knowledge of structure of the cervix (especially the collagen network) is important to~          detect problems that may affect pregnancy and other women s health issues, no~          noninvasive techniques are available to evaluate such changes.~        -  A specially designed polarized camera attached to a conventional colposcope can be used~          to take cervical images. Analyzing these images may enable researchers to better~          visualize the collagen network in the cervix.~      Objectives:~        -  To explore and gain experience with the use of a polarized imaging system to study~          cervical structure.~        -  To evaluate the usefulness of a polarized imaging system in studying the cervical~          structure of healthy nonpregnant women.~      Eligibility:~      - Adult females (at least 18 years of age) who are having regular menstrual cycles and are~     not on hormonal medications.~      Design:~        -  Images will be takes from the cervix in two different phases of menstruation cycle time,~          one in the follicular phase (before ovulation) and another one in the luteal phase~          (after ovulation).~        -  The images of the cervix will be taken with a vaginal speculum in place with the camera~          attached to a colposcope. The colposcope will illuminate the cervix using polarized~          light. Three random cervical locations will be photographed~   "
199165|NCT00955851|"~     Investigators in the Division of Infectious Diseases and the Division of Hospital Medicine of~     The George Washington University Medical Center are carrying out a study to determine if~     hospitalized patients receiving the polyvalent pneumococcal vaccine during an acute illness~     develop an adequate antibody response. The study group will consist of individuals diagnosed~     with pneumonia and admitted to the Medicine ward under the Pneumonia Core Measure Protocol,~     which assigns appropriate patients for vaccination based on the current guidelines from the~     Advisory Committee on Immunization Practices (ACIP).~   "
199166|NCT00955838|"~     The trial aims to test a novel rehabilitation device for subacute stroke hemiplegic upper~     limbs based on state-of-the-art non invasive Brain-Computer Interface (BCI) robotic~     rehabilitation in a clinical setting. The investigators aim to prove the clinical efficacy~     and safety of BCI therapy over traditional rehabilitation methods.~   "
199167|NCT00955825|"~     The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of~     grass pollen allergen extract compared to placebo in adult patient with allergic~     rhinoconjunctivitis.~   "
199168|NCT00955812|"~     The goal of this clinical research study is to find the highest tolerable dose of OPB-31121~     that can be given to patients with an advanced solid tumor. The safety of this drug will also~     be studied.~   "
199169|NCT00955799|"~     The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in~     the treatment of subjective tinnitus in comparison to placebo.~   "
199172|NCT00955760|"~     Primary Objectives:~      • Assess the effects of poly-specific cytochrome P450 and drug-transporter induction by~     repeated dose Rifampicin (600 mg/day) co-administration on the single-dose pharmacokinetics~     of Neramexane.~      Secondary Objectives:~      • To assess safety and tolerability of Neramexane single dose treatment alone and~     co-administration of a Neramexane single dose with a Rifampicin repeated dose treatment.~   "
199173|NCT00955747|"~     The purpose of this trial was to evaluate the effectiveness and safety of Naturlose~     (Tagatose) for glycemic control in people with Type 2 diabetes who were not taking other~     medications for the condition and who were under diet control and exercise.~      The study lasted approximately one year. HbA1c was monitored every 2 months after entry into~     the study. Safety and tolerance for tagatose were assessed every 2 months throughout the~     study. A total of 14 visits were made to the study site.~   "
199174|NCT00955734|"~     Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist~     motion. Early motion is generally prescribed in the belief that it will result in greater~     final motion without compromising fixation. However, studies have failed to demonstrate~     clinically significant improvement in final wrist motion (> 1 year follow up) compared to~     treatments requiring longer immobilization such as external fixation or bridge plating.~   "
199175|NCT00955721|"~     The purpose of this study is to build on the efficacy of the GEMOX regimen by adding~     Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination~     of these three agents, the investigators plan to evaluate the safety in a run-in phase I~     portion in order to define the recommended phase II dose (RPTD). The phase II trial will~     enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary~     estimate of progression-free survival (primary endpoint of the trial) in the target~     population.~   "
199176|NCT00955708|"~     The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term~     performance of the ACUITY Spiral Left Ventricular Lead.~   "
199177|NCT00955695|"~     RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in~     patients with advanced non-small cell lung cancer. It is not yet known whether radiation~     therapy is more effective than observation in patients with advanced non-small cell lung~     cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see~     how well it works compared with observation in preventing brain metastases in patients with~     advanced non-small cell lung cancer.~   "
199178|NCT00955682|"~     Subjects were previously vaccinated at 12 to 23 months of age. This extension study starts 24~     months after vaccination and the subjects who were vaccinated in the primary study will be~     enrolled in this extension phase. No new subjects will be enrolled.~   "
199179|NCT00955669|"~     Objective:~      To compare the effect and safety of autologous transplantation of bone marrow mesenchymal~     stem cells(MSCs) and mononuclear cells(MNCs) on Diabetic patients with Critical Limb Ischemia~     and Foot Ulcer.~      Methods:~      patients were randomized into the A group and the B group by use of a randomization table.~     One lower limb in A group or in B group was selected randomly for MSCs or MNCs~     transplantation as MSCs or MNCs group, the other lower limb in the same patient was selected~     for placebo（normal saline ,NS）injection as NS group.~      The whole procedures of this clinical trial were blinded to both patients and~     investigators.Patients in both groups received the same ordinary treatment. Meanwhile, MSCs~     and MNCs were transplanted into the impaired lower limbs respectively. Follow-up index~     include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial~     index,Transcutaneous oxygen pressure,magnetic resonance angiography) and safety (infection of~     the injection site, immunological rejection, and tumour generation).~   "
199180|NCT00955656|"~     The proposed study will utilize a survey format to examine the attitudes, perceptions, and~     practices of primary care providers in the Delta region of Arkansas.~   "
199181|NCT00955643|"~     Evaluation of the clinical effect of hyperbaric oxygen therapy (HBOT) adjunctively to scaling~     and root planing (SRP) in the treatment of severe case of chronic periodontitis.~   "
199182|NCT00955630|"~     The purpose of this study is to evaluate the safety and effectiveness of intravitreal~     ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular~     histoplasmosis.~   "
199183|NCT00955617|"~     This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced~     MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.~   "
199184|NCT00955604|"~     To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients~     receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline~     without antidepressant medications and compared to PD patients receiving antidepressants, but~     not rasagiline.~   "
199185|NCT00955591|"~     RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human~     papillomavirus. It is not yet known which type of swab is more effective in collecting cell~     samples for anal Pap tests and human papillomavirus tests in men who have sex with men.~      PURPOSE: This clinical trial is comparing two types of swabs in collecting cell samples for~     anal Pap tests and human papillomavirus tests in men who have sex with men.~   "
199186|NCT00955578|"~     The investigators' goal is to identify the mutation in the gene that is responsible for the~     development of segmental dysplastic nevi. To identify the gene the investigators may use a~     candidate gene approach (i.e. sequence specific genes that are thought to be involved: NRAS,~     BRAF, etc) or a genome-wide approach trying to implicate regions in the genome~     (Loss-of-heterozygosity or copy number changes on comparative genomic hybridization).~   "
199187|NCT00955565|"~     The purpose of this study is to compare the precision of computer-assisted navigation for hip~     screw implantation to conventional fixation without navigation.~   "
199188|NCT00955552|"~     The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin~     sulfate association in the treatment of patients with osteoarthrosis of the knee.~   "
199189|NCT00955539|"~     30% of heart failure patients that receive a device for cardiac resynchronization therapy~     fail to show clinical improvement. The reason for lack of response is still unclear but~     factors such as scar tissue in the heart musculature, inadequate lead placement,~     device-settings and the degree of dyssynchrony before implant seems to be important. In this~     study, these factors are further investigated.~   "
208724|NCT00828919|"~     To allow continuation of treatment of patients experiencing benefit from AG 013736~   "
199190|NCT00955526|"~     The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of~     istradefylline for reducing the mean total hours of awake time per day spent in the OFF state~     in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet~     entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses~     of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks~     and will have interim visits and end of treatment visit to assess the efficacy and safety of~     istradefylline.~   "
199191|NCT00955513|"~     The main purpose of this trial is to compare the efficacy and safety of diclofenac~     diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in~     the treatment of acute ankle sprains (distortions).~   "
199192|NCT00955500|"~     The purpose of this study is to compare a normal-protein diet containing branched-chain amino~     acids to a low-protein diet in patients with non-terminal cirrhosis (MELD < 25) who have~     developed an episode of hepatic encephalopathy within two months prior to inclusion.~   "
199193|NCT00955487|"~     Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns.~     The condition involves abnormal development of lung tissue and is characterized by~     inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce~     the incidence of BPD and another commonly associated condition called pulmonary hypertension,~     which is high blood pressure in the vessels carrying blood to the lungs.. This study will~     determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary~     hypertension, and death in premature newborns.~   "
199194|NCT00955474|"~     The purpose of this study is to compare the efficacy and tolerability of Seroquel monotherapy~     for the treatment of Major Depression with Psychotic features with Seroquel plus Selective~     Serotonin Reuptake Inhibitor.~   "
199195|NCT00955461|"~     The purpose of this study is to compare the results of treatment between the side of the face~     treated with the RevLite Laser and the side of the face treated with a fractionated laser~     system.~   "
199196|NCT00955448|"~     Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An anterior~     wall prolapse occurs when the front of the vagina loses its support, and the bladder drops~     down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.~      One of the treatment options available is to repair the anterior wall surgically. The goals~     of surgery are to return the anatomy to its usual position, ensuring that all the pelvic~     floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair~     would also be long lasting.~      Two surgical options are routinely performed in Calgary for repair of an anterior compartment~     prolapse. One option involves fixing the organs back in place using sutures. The other option~     uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for~     use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The~     investigators do not know which of these two options is the best surgical procedure. Both may~     have different advantages that would result in better results. This study is designed to try~     and find out if one of these procedures is better, and if a larger study may be needed.~   "
199197|NCT00955435|"~     RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This clinical trial is studying blood and urine samples in patients with newly~     diagnosed localized prostate cancer treated with hormone therapy and radiation therapy.~   "
199198|NCT00955422|"~     Background:~        -  Individuals who demonstrate symptoms of Alzheimer s disease, such as progressive memory~          loss, may be eligible to participate in National Institutes of Health research studies.~          However, other physical and psychological conditions may produce symptoms similar to~          those of Alzheimer s disease. To determine whether a patient meets the eligibility~          criteria to participate in a research protocol, researchers must perform a series of~          diagnostic tests and procedures.~        -  These evaluations are designed to evaluate a participant s general medical condition~          (for example, blood tests and neurological exams) and to confirm a diagnosis or rule out~          an individual for consideration. They maximize the safety for participants in studies~          conducted at the National Institutes of Mental Health.~      Objective:~      - To determine the eligibility of individuals for active Alzheimer s disease protocols.~      Eligibility:~      - Individuals 45 years of age and older who have been having memory problems that have been~     getting worse with time and have been interfering with everyday life.~      Design:~        -  Required tests and procedures for various research studies may include the following:~        -  Medical history and physical examination, including a psychiatric evaluation.~        -  Neuropsychological tests to test memory, mood, concentration, and thought processes.~        -  Blood and urine tests.~        -  Imaging studies (X-rays, magnetic resonance imaging (MRI), computerized tomography (CT),~          positron emission tomography (PET)).~        -  Additional blood samples and MRI data for future use.~        -  After all eligibility assessments are complete, participants may be offered~          participation in one or more research protocols~   "
199199|NCT00955409|"~     The purpose of this study is to assess the long term safety, tolerability, and immunogenicity~     of ACC-001, an investigational active immunization product+, in subjects with mild to~     moderate Alzheimer's disease.~   "
199200|NCT00955396|"~     In this study the investigators will determine whether there is any effect of GSK1014802 on~     ambulatory blood pressure. This will be a randomized, double-blind, placebo-controlled,~     repeat dose, 2 period cross-over study conducted in healthy male and female subjects.~     Approximately 60 subjects will be randomised to receive GSK1014802 400 mg bid and placebo for~     36 days with at least 1 week between treatment sessions. A follow-up will occur 7-14 days~     after the last dose.~   "
199227|NCT00955032|"~     The purpose of this research study is to attempt to treat apathy in Parkinson's disease (PD)~     using high-frequency repetitive transcranial magnetic stimulation (rTMS) of the brain and to~     investigate the patterns of brain activation that may be involved in apathy. It is~     hypothesized that high-frequency rTMS of the left mid-dorsolateral frontal cortex will~     improve apathy in PD.~   "
199228|NCT00955019|"~     This study is being done to see how biomarkers (abnormalities in molecules of cells ) present~     in their Barrett's esophagus agree with results from surveillance biopsies; and to compare~     three different brush devices used to collect cells to see which of these 3 brush devices~     obtains a higher number of cells.~   "
199201|NCT00955383|"~     GSK2190915 is currently in development for the treatment of asthma. This study aims to assess~     the safety and tolerability of single doses of GSK2190915 in healthy Japanese subjects. The~     study will also look at the pharmacokinetics (PK) and pharmacodynamics (PD) of single doses~     of GSK2190915 and aims to characterise the PK/PD relationship in healthy Japanese subjects.~     Twelve healthy Japanese subjects will take part in this single escalating dose study and~     subjects will receive one of five possible treatments, 10 mg, 50 mg, 150 mg, 450 mg~     GSK2190915 or placebo in each treatment period. Blood samples (for safety, pharmacokinetics~     and pharmacodynamics), urine samples (for safety and pharmacodynamics) and ECGs, blood~     pressure readings, physical examinations and a review of adverse events will take place at a~     number of timepoints pre and post each dose. A minimum 7 day washout between treatment~     periods will be required. Regardless if a subject completes or prematurely withdraws from the~     study, a follow up visit will be completed 7-10 days following last dose.~   "
199202|NCT00955370|"~     Background:~        -  Rare and undiagnosed conditions are often chronic and disabling, with symptoms affecting~          different organ systems at various levels of severity. Perhaps the most challenging~          feature of an undiagnosed medical condition that has lasted 2 or more years is its~          characteristic uncertainty. In the absence of a diagnosis, health care professionals can~          provide only limited treatment and prognostic information.~        -  In the case of a child with an undiagnosed condition, the uncertainty that accompanies~          what is often a chronic, debilitating medical condition and an undefined prognosis may~          have physical, psychological, social, and spiritual implications for the entire family.~          Research suggests that parents of a child with an undiagnosed medical condition may be~          at significantly increased risk of anxiety, depression, poor health, and overall lower~          quality of life.~        -  It is not well understood how individuals cope with and adapt to chronic uncertainty,~          and the factors that influence this process. To design future interventions, descriptive~          studies are needed to reveal predictors that can be manipulated to improve outcomes.~      Objectives:~        -  To examine whether perceptions of uncertainty, and perceived personal control, are~          associated with coping and adaptation.~        -  To examine how the length of time elapsed since child was identified as sick and~          perceptions of uncertainty affect coping and adaptation.~        -  To assess how perceptions of uncertainty, time elapsed since child became sick,~          optimism, and perceived personal control affect coping and adaptation.~      Eligibility:~        -  Parents (older than 18 years of age) of children who have an undiagnosed medical~          condition.~        -  Participants must have a working e-mail address or fixed postal address.~      Design:~        -  Parents will be recruited from Web-based support networks for parents of undiagnosed~          children through Web site postings, electronic mailing lists, and printed newsletter~          postings.~        -  Participants will be asked to complete a questionnaire about their experiences in living~          with a child who has an undiagnosed but chronic medical condition. The main outcome~          variable is adaptation to living with one's child's undiagnosed medical condition.~        -  Participants have the option to complete an online or paper version of the~          questionnaire. The questionnaire should take between 20 and 30 minutes to complete.~        -  No medical treatments are specifically offered as a part of this study.~   "
199203|NCT00955357|"~     To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects~     with uncontrolled partial-onset seizures after prior treatment with a monotherapy~     Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at~     least 2 AEDs.~   "
199204|NCT00955344|"~     The purpose of the study is to determine if a Web-based intervention increases physician~     rates of colorectal cancer recommendation rates in a group of physicians participating in the~     American Board of Internal Medicine's Maintenance of Certification Program. This study will~     also compare the content of practice improvement plans submitted by the diplomats in each~     study arm to determine the components of the plans that are associated with colorectal cancer~     rates.~   "
199205|NCT00955318|"~     The purpose of this study is to evaluate the safety and efficacy of KW-6500 when administered~     as long-term subcutaneous self-injections in Parkinson's disease patients with motor response~     complications on levodopa therapy.~   "
199206|NCT00955305|"~     This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab~     (CPB) work when given with or without cixutumumab in treating patients with non-small cell~     lung cancer that is stage IV or has come back (recurrent). Drugs used in chemotherapy, such~     as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of~     tumor cells to grow and spread. Other types of monoclonal antibodies, such as cixutumumab,~     may find tumor cells and help kill them. It is not yet known whether giving more than one~     drug (combination chemotherapy) together with bevacizumab is more effective when given with~     or without cixutumumab in treating patients with non-small cell lung cancer.~   "
199207|NCT00955292|"~     This phase 1 study of quarfloxin (CX-3543) is designed to test the safety, tolerability, and~     highest safe dose of this drug when administered intravenously weekly for three weeks of a~     four week cycle in patients with advanced solid tumors.~   "
199208|NCT00955279|"~     This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo~     (placebo looks like the drugs being studied, but has no active ingredients). The purpose of~     this research study is to determine if ustekinumab or golimumab is safe and to determine its~     effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin~     involvement. Patients with pulmonary involvement constitute the primary population for~     analysis, and patients with skin involvement constitute the secondary population; a patient~     may be in both populations. The study will be conducted at approximately 40 sites globally.~   "
199209|NCT00955266|"~     Successful heart surgery requires the resumption of a strong beating heart prior to~     separation from the heart and lung machine. There are different ways to do this. At this~     hospital, the surgical team usually gives calcium to people when they come off of the heart~     and lung machine because some doctors believe that calcium can jump start the heart. Not~     every hospital does this.~      Some people think that calcium may have a side effect of making the heart more stiff. Stiff~     hearts do not beat as well or receive as much blood to tissues as non-stiff hearts. If~     calcium makes the heart stiff, then doctors may have to use other medicines to support the~     heart in the operating room and the intensive care unit. This may ultimately lead to poorer~     outcomes including a longer stay in the intensive care unit and in the hospital.~      This study is being performed to find out if calcium has the side effect of making the heart~     more stiff. This study compares calcium to placebo. The placebo looks exactly like the~     calcium, but it contains no calcium. During this study patients may receive placebo instead~     of calcium. Neither the doctor nor the study team will know which drug the subject will~     receive.~   "
199210|NCT00955253|"~     To find out if spatial neglect following stroke and brain injury can be reduced using~     guanfacine, a drug that was shown to improve neglect in two stroke patients in a previous~     pilot study (Malhotra et al, 2006). In this trial, the effects of guanfacine will be examined~     in a larger number of patients, and there will also be a systematic assessment of whether the~     drug is only effective in patients with particular patterns of brain damage.~   "
209537|NCT00818181|"~     This trial is performed to assess safety of a sublingual birch pollen extract.~   "
199211|NCT00955240|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Giving radiation therapy together with combination~     chemotherapy and cetuximab may kill more tumor cells.~      PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin,~     fluorouracil, and cetuximab to see how well it works in treating patients with locally~     advanced anal cancer.~   "
199212|NCT00955227|"~     The objective of this study is to determine if the administration of a cholesterol lowering~     drug like ezetimibe will reduce circulating omega-3 fatty acid (ALA) levels in patients with~     heart disease and hypercholesterolemia.~      The investigators hypothesize that their data will discover that patients receiving ezetimibe~     require additional dietary supplementation with omega-3 supplements to insure that these~     beneficial fatty acids are available to these patients.~   "
199213|NCT00955214|"~     The utilization of paclitaxel-eluting coronary stents in small vessel diseases is effective~     in reducing both repeat revascularization and major adverse cardiac events within two year~     follow-up. To evaluate the procedural, short and long term clinical outcomes of the Taxus~     Liberte™ Paclitaxel-Eluting Coronary Stent in small coronary arteries of ≤ 2.5 mm in the~     reference vessel diameter.~   "
199214|NCT00955201|"~     This study will determine the type and combination of exercise needed to rehabilitate the~     neuro-compromised diabetic Veteran. Guided exercise protocols may prove to be practical~     therapeutic options for the prophylactic management of diabetic subjects with neuropathy.~   "
199215|NCT00955188|"~     RATIONALE: A computer program that provides information on colorectal cancer screening based~     on a patient's test preferences may be more effective than a computer program that gives~     standard information in helping patients get regular colorectal cancer screenings.~      PURPOSE: This randomized clinical trial is studying computer-based tailored information to~     see how well it works compared with standard information for colorectal cancer screening.~   "
199216|NCT00955175|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor over a shorter period of time may kill more tumor cells and cause less damage to~     normal tissue.~      PURPOSE: This phase II trial is studying the side effects of hypofractionated 3-dimensional~     radiation therapy and to see how well it works in treating patients with newly diagnosed~     stage I, stage II, or stage III non-small cell lung cancer.~   "
199217|NCT00955162|"~     Patients who admit to using buprenorphine by the intravenous route will be randomized to~     either Subutex or Suboxone and be followed up for 3 months to determine if there is less~     injection with Suboxone than with Subutex based primarily on patient diaries.~      Patients randomized to Suboxone may continue to receive the product for a further 9 months at~     their request and will be monitored at 3 month intervals.~      Patients will receive a payment for the inconvenience of keeping a daily diary and to cover~     their travel expenses.~   "
199218|NCT00955149|"~     Primary sclerosing cholangitis (PSC) is a chronic inflammatory condition of the bile ducts of~     unknown etiology. It is characterized by diffuse inflammation and stricturing of the entire~     biliary tree, eventually resulting in cirrhosis of the liver. Patients with PSC are at~     increased risk for the development of cholangiocarcinoma (CCA), a cancer arising from bile~     duct epithelium. This risk is estimated to be approximately 1 to 1.5% per year. It is~     postulated that chronic inflammatory changes in the biliary epithelium promote CCA formation.~     The prognosis of CCA is fatal. The only potentially curative therapy is surgical; however,~     only a minority of patients qualify for surgical treatment.~      Several studies have demonstrated overexpression of the epidermal growth factor receptor~     (EGFR) in CCA cells. EGFR is a type 1 tyrosine kinase promoting cell proliferation, migration~     and altered cell adhesion - typical characteristics of malignant neoplasias. In CCA cells,~     EGFR-activation is sustained resulting in cancer progression. In human CCA samples,~     EGFR-expression correlates with higher histologic grade, poor prognosis, and risk of~     recurrence. The EGFR gene is located on the short arm of chromosome 7 (7p12). Chromosomal~     abnormalities of the bile duct epithelium, particularly trisomy 7 (i.e. three copies of~     chromosome 7) can be detected in biliary epithelial samples obtained by endoscopic retrograde~     cholangiopancreatography (ERCP) in PSC patients. The finding of cells with trisomy 7 has~     preceded the development of aneuploidy and multiple chromosomal abnormalities in a number of~     patients, the latter chromosomal abnormalities are characteristic of CCA. Trisomy 7 amplifies~     the gene for EGFR thereby presumably promoting overexpression of this growth factor receptor.~     In a cohort of patients with Trisomy 7 and Primary Sclerosing Cholangitis patients followed~     for 1 year, the rate of development of Cholangiocarcinoma was 35% (n=37, Dr. Gores,~     unpublished observation). Patients without cytologic abnormalities were at minimal risk for~     the development of CCA.~      Erlotinib (Tarceva) is a human EGFR type 1 tyrosine kinase inhibitor. Tarceva received FDA~     approval as single agent treatment for patients with locally advanced or metastatic non-small~     cell lung cancer. In a randomized, double blind, placebo controlled trial of 731 patients,~     receiving 150 mg of Tarceva or placebo once daily, median survival was prolonged to 6.7~     months from 4.7 months (p<0.001). Analysis of epidermal growth factor receptor expression~     (45% of total study patients) demonstrated greater survival benefit in EGFR positive~     patients. Tarceva in combination with Gemcitabine is also FDA approved as first line therapy~     in patients with locally advanced, unresectable or metastatic pancreatic cancer.~      Our central hypothesis is that patients with trisomy 7 will have carcinogenic changes~     including EGFR overexpression. EGFR blockade will inhibit a growth/survival advantage for~     these premalignant clones eliminating them from the biliary epithelium. As an initial step~     towards testing this hypothesis, the tolerability of Tarceva in this patient population needs~     to be established. This study will assist in determining the safety and tolerability of~     Tarceva in patients with primary sclerosing cholangitis. This study will be followed by a~     Phase 2 randomized controlled trial of Tarceva in patients with Primary Sclerosing~     Cholangitis with Trisomy 7.~   "
199219|NCT00955136|"~     The study will see if mechanical impulses delivered by an echocardiographic probe during a~     continuous infusion of MRX 801 are capable of improving blood flow in smaller heart vessels~     in patients with acute coronary syndromes.~   "
199220|NCT00955123|"~     Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with~     active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver~     plays an important role in this stress-catabolism by increasing the production of urea during~     the inflammatory process.~      The purpose of this study is to examine the effect of the anti-inflammatory drugs~     prednisolone and infliximab on the regulation of the urea synthesis in patients with active~     ulcerative colitis and Crohn's disease.~   "
199221|NCT00955110|"~     The purpose of this study is to compare the subjective and objective effects of Oxymorphone~     ER (Opana ER) versus Oxycodone CR (Oxycontin).~   "
199222|NCT00955097|"~     The primary purpose of this study is to demonstrate the safety and effectiveness of using an~     intra-operative ultrasound contrast agent(Definity®) for the identification of known liver~     tumors.~   "
199223|NCT00955084|"~     The primary objective of this study is to allow rollover of the two remaining subjects from~     the other XL999 studies to continue to receive XL999.~      The secondary objectives of this study are as follows:~        -  To evaluate tumor response after long term repeat administration of XL999 in two~          subjects rolled over from other XL999 studies.~        -  To characterize the long term safety and tolerability of XL999 after repeat~          administration in two subjects rolled over from other XL999 studies.~        -  To characterize the long term effects of XL999 on cardiac function after repeat~          administration in two subjects rolled over from other XL999 studies.~   "
199224|NCT00955071|"~     The investigators will randomize abdominally obese men and women at increased health risk to~     one of the following 4 conditions: 1) No-exercise, wait list controls (C), 2) Low volume, low~     intensity exercise (LVLI), 3) High volume, low intensity exercise (HVLI), 4) Low volume, high~     intensity exercise (LVHI).~      The primary aim of the trial is to determine the effects of varying exercise dose (energy~     expenditure, kcal) or intensity (relative to VO2max (cardiorespiratory fitness)) on waist~     circumference and glucose tolerance. The investigators will test the following hypotheses: 1)~     That the reduction in waist circumference and improvement in glucose tolerance in response to~     all treatments will be greater than controls. 2) That reduction in waist circumference and~     improvement in glucose tolerance in HVLI and LVHI will be greater than LVLI. 3) That~     hypotheses 1 and 2 are true independent of gender.~   "
199225|NCT00955058|"~     The purpose of this study is to evaluate the effect of oral contraceptive on the serum free~     prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with~     cyproterone compound.~   "
199226|NCT00955045|"~     The primary objective of this study was to establish the long-term tolerability and safety of~     istradefylline treatment in subjects with Parkinson's disease treated with~     levodopa/carbidopa. In addition, treatment response and maintenance of response were~     assessed.~   "
199229|NCT00955006|"~     The purpose of the study is to determine the safety of mucosal immune responses to a DNA HIV~     vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.~   "
199232|NCT00954967|"~     This study addresses an important problem in public health, smoking in diabetics. The~     morbidity and mortality observed in diabetics is linked to macro and microvascular problems.~     The consumption of tobacco has a multiplying effect on these vascular problems in diabetics.~     This study aims to evaluate the effectiveness of an intensive intervention in tobacco~     addiction in diabetic patients in primary care.~   "
199233|NCT00954954|"~     The aim of this prospective study is to compare the clinical and radiographic outcomes of~     standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB)~     total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed~     with a high-flexion PS RP-MB design would improve range of motion, and that this would be~     reflected by a better clinical outcome and greater patient satisfaction.~   "
199234|NCT00954941|"~     The goal of this clinical research study is to compare the effectiveness of receiving a~     combination of ondansetron and aprepitant to receiving ondansetron alone in helping to~     prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk~     (HR) Myelodysplastic syndromes (MDS) who are receiving cytarabine. The safety of this drug~     combination will also be studied.~   "
199235|NCT00954928|"~     If operating on the anticoagulated patient has been safe for one of the investigators'~     surgeons for the past 10 years then providing prospective data that substantiates this could~     prevent complications related to the discontinuation of anticoagulation for hand surgery~     patients in the future.~   "
199236|NCT00954915|"~     The purpose of this study is to determine whether teplizumab is safe when administered~     subcutaneously (by needle under the skin) in subjects with psoriasis. The study will also~     evaluate how long teplizumab stays in the blood and how long it takes for it to leave the~     body, what is the highest dose that can safely be given, and whether it improves psoriasis.~   "
199237|NCT00954902|"~     The purpose of this study is to assess whether feeding highly antioxidant spices of providing~     these same antioxidants as capsules is able to affect cardiovascular risk measures. Because~     this is a new area of research, the investigators will use many measures to assess this~     question including blood markers, tests of blood vessel health, measures of blood pressure~     responses, measures of clotting activity, and other inflammation measures.~   "
199238|NCT00954889|"~     The purpose of this study is to explore the efficacy and safety of tamsulosin 0.4mg (Harnal®~     D. 0.2mg, 2T) in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® D 0.2mg, 1T).~   "
199239|NCT00954876|"~     The combination of capecitabine and cetuximab as first-line therapy will result in improved~     progression free survival compared to single agent capecitabine in patients with KRAS wild~     type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan~     combination therapy are eligible for this study.~   "
199240|NCT00954863|"~     Based on the investigators previous study, seventy-four of 786 HIV-1 isolates (9.4%),~     collected between 1999 to 2006, harbored one or more primary mutations associated with~     antiretroviral resistance to reverse-transcriptase inhibitors (RTIs) or protease inhibitors~     (PIs) in naïve patients. However, the drug resistance profiles for the HIV-1 integrase gene~     is unclear. Three objectives are proposed:~        1. To investigate and compare the drug resistance profiles for the HIV-1 integrase gene~          between experienced and naive patients, who has not being exposed to Raltegravir.~        2. To investigate and compare the drug resistance profiles for the HIV-1 integrase gene~          between different subtypes (subtype B, CRF01_AE and CRF07_BC).~        3. To identify potential amino acid mutations in the integrase gene, which might affect the~          efficacy of Raltegravir.~   "
199241|NCT00954850|"~     The Canadian Severe Asthma Network (CSAN) was developed to gain a better understanding of the~     clinical, environmental, socio-economic, work-related, and biological characteristics of~     severe asthmatics (SA) that may account for poor response to clinically available therapies~     for asthma.~      This network of clinical and basic researchers will be a means by which Canadian~     investigators can develop and conduct research in this small patient group, which could lead~     to better clinical management of SA.~      Patient information will be entered into the CSAN database (created by PI Dr. Vethanayagam in~     connection with Mr. Jack Yeung) and will help researchers and doctors from multiple hospitals~     and universities across Canada to understand this subpopulation of asthmatics better. It will~     help to answer questions regarding SA epidemiology, asthma education, inflammatory~     monitoring, risks of near fatal asthma (NFA), symptom perception, changes in lung structure~     and function, co-morbidities, and the effectiveness of developing regional severe asthma~     clinics. Two of the early projects the investigators will be working on are psychosocial~     co-morbidities in asthma and medication coverage related to asthma.~      There will also be biobanking of sputum samples and/or bronchoscopy samples (such as BALs &~     lung washings) that are being obtained for clinical purposes. Also, for those consented for~     biobanking blood and urine will be collected, separate from clinical care, and stored in the~     biobank. The Canadian Biosample Repository (CBSR) will be storing our biobanked samples. The~     investigators will be following the CBSR policies for storage and security. Tissue research~     will be conducted in the future, and separate ethics approval will be obtained for each~     project.~   "
199242|NCT00954837|"~     Thyroid nodules are common (prevalence of 12.7% in women), but are malignant in only 5% of~     cases. International experts agree that a preliminary cytological examination by fine needle~     aspiration (FNA) is required. The management of patients with cytological results consistent~     with malignant or suspicious for malignancy nodules is well codified and generally involves~     surgery. However, there is no consensus concerning 1) the utility of a second FNA during the~     monitoring of benign nodules. Certain studies have recommended a second FNA, whereas others~     have recommended ultrasound monitoring alone; 2) the contribution of ultrasound criteria to~     the decision as to whether to carry out a second FNA, particularly if the nodule increases in~     size; 3) the management of nodules classified as doubtful or suspect on needle biopsy, many~     of which prove to be benign (20 to 30% are malignant), raising questions about the utility of~     systematic thyroid surgery or the justification for a second FNA; 4) the management of~     patients with non significant (NS) findings on FNA, for whom immediate surgery, monitoring or~     a second FNA may be recommended and 5) the procedure to be followed for nodules present in~     patients with multinodular thyroid disease.~   "
199323|NCT00953758|"~     This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on~     select hematologic malignancies.~   "
227400|NCT00580970|"~     Lovastatin may protect against late effects of radiation therapy in patients with prostate~     cancer~   "
199243|NCT00954824|"~     People who are overweight are at increased risk of heart disease. Being overweight and having~     heart disease are linked in that both involve inflammation. Inflammation refers to the body's~     first line of defense against infection and injury. Metabolic changes in cholesterol,~     triglycerides (fat in the blood) and sugar in the blood caused by inflammation are similar to~     that in some people who are overweight. The investigators wish to examine the effects of~     inflammation on these metabolic changes that may lead to heart disease.~   "
199244|NCT00954811|"~     Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six~     doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of~     OHSS.~   "
199245|NCT00954798|"~     The purpose of this study is to generate data on immunogenicity and safety of the monovalent~     H1N1 vaccine in support of the development and registration.~      Primary objectives:~        -  To describe the immune response to study vaccine 21 days after each vaccination.~        -  To describe the antibody persistence 8 months after the first vaccine administration~          using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects~          who received two injections.~        -  To describe the immune response against the A/H1N1 strain using HAI method 21 days after~          a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza~          vaccine (TIV) administered 13 months after the first vaccination in a subset subjects~          who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin~          A/H1N1 strain.~        -  To describe the safety profiles of study vaccines in all participants.~   "
199246|NCT00954785|"~     The aim of the study is to measure the effectiveness of treatment over 7 days with commonly~     used anti-inflammatory medications namely etoricoxib and diclofenac (Voltaren) on reducing~     the severity of pain, swelling and loss of function (range of movement, proprioception)~     arising from a mild to moderate sprain (partial tear) of the lateral (outer) ligaments of the~     ankle joint. This injury is commonly known as an ankle sprain.~   "
199247|NCT00954772|"~     The purpose of this research study is to investigate any changes seen in mood or behavior~     following deep brain stimulation for movement disorders.~   "
199248|NCT00954759|"~     Infantile colic is a condition that affects more than 10% of babies and their families. The~     reason, and hence the proper treatment, for this condition is unknown and many causes have~     been suggested. One of the treatments that parents choose is chiropractic manipulation. In~     Denmark, around 4,000 babies are treated for colic by chiropractors each year although the~     effect of chiropractic treatment of infantile colic has not been properly scientifically~     evaluated.~      The effect of chiropractic treatment on infantile colic needs to be investigated since this~     is a very common disorder with no known effective treatment but with good empirical evidence~     of the value of chiropractic treatment. Although it is usually considered to be a benign and~     self-limiting condition, some studies suggest there might be long-term effects in terms of~     psychomotor problems. In worst case, the infants' crying may also lead to violence and~     'shaken baby syndrome'.~      Null hypothesis: There is no effect of chiropractic treatment on the course of infantile~     colic.~      This study is a controlled clinical trial, where infants fulfilling the diagnostic criteria~     for colic will be randomized into two groups. One group will receive treatment and the other~     won't. This will determine the overall effect and furthermore, subgroup analyses will be~     performed to identify possible subgroups of infants who will benefit the most from the~     treatment.~      The results from subgroup analyses can help to identify children who might benefit from the~     treatment. Then treatment can be initiated early and a lot of hardship can be avoided for~     both the babies and the families.~   "
199249|NCT00954746|"~     The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500~     treatment regimen. This study will also evaluate long-term safety and progression of disease~     in joints.~   "
199250|NCT00954733|"~     The estimation of the partial pressure of carbon dioxide (PCO2) in the arterial blood is used~     to judge the adequacy of ventilation during spontaneous and controlled ventilation. Although~     the gold standard for monitoring PCO2 remains arterial blood gas sampling, this requires an~     invasive procedure and provides only an intermittent estimate of what is frequently a~     continuously changing value. The solution to this problem has been the development and~     validation of accurate noninvasive monitoring techniques which provide a continuous~     intraoperative estimate of PCO2.The most commonly used noninvasive technique to monitor PCO2~     is measurement of the end tidal CO2 (PECO2) . However, sampling errors and patient -related~     issues such as ventilation-perfusion mismatch, patient positioning or decreases in pulmonary~     blood flow may influence the accuracy of PECO2 monitoring (1-3). Nasal capnography has been~     proved to be an accurate monitor during the post-operative period (4) but its ability to~     accurately detect hypoventilation associated with deep sedation has not been studied.~      According to the American Society of Anesthesiologist standards for basic monitoring,~     continuous capnography is required for all patients undergoing general anesthesia but it is~     optional for MAC/sedation cases. The need for CO2 monitoring has been studied by other~     medical specialties that use procedural sedation, including gastroenterology (12) and~     emergency medicine (13, 14) and many specialties now recommend capnography as a standard~     monitor.~      Patients receiving supplemental oxygen may experience significant persistent hypoventilation~     leading to progressive hypercarbia and acidosis which may go undetected for a significant~     time interval since the routinely monitored SpO2 may be maintained within normal range. A~     recent study has shown that despite the fact that end tidal CO2 is reliable in detecting~     apnea , increasing oxygen flow rates decrease the amplitude of measured CO2, probably via~     dilution, making the quantitative value less reliable as an assessment of adequacy of~     ventilation (15). Furthermore, during hypoventilation there is reduced alveolar ventilation~     and the end tidal CO2 is not a true reflection of arterial CO2.~      Transcutaneous measurement of PCO2(PtcCO2) is a non-invasive method of measuring PCO2 that~     has been used much less frequently due to technical difficulties with earlier transcutaneous~     electrodes. Preliminary studies of the reliability of the current PtcCO2 electrodes (TOSCA,~     Linde Medical Sensors, and Basel, Switzerland) have shown good correlation of arterial and~     transcutaneous measurements in both adult volunteers and anesthetized subjects (5). PtcCO2 is~     measured with a sensor attached by a low pressure clip to an earlobe. The sensor probe heats~     the earlobe to 42 degrees Celsius to enhance blood flow. The current sensors have also been~     evaluated in anesthetized children (7, 8), anesthetized adults (9, 10) and critically ill~     neonates (11) and all these studies revealed a good correlation between PtCO2 and PaCO2.~   "
199251|NCT00954720|"~     Recent retrospective studies have suggested that iron overload is a clinically important~     problem in patients undergoing ablative stem cell transplantation. However, these studies~     relied on serum ferritin as a surrogate of iron overload, which limits the conclusions that~     can be drawn from such analyses. Therefore, the investigators are conducting a prospective~     study to more rigorously examine the prevalence, mechanisms, and consequences of iron~     overload in this patient population.~   "
199252|NCT00954707|"~     CYPRESS: A Prospective,Randomized,Multi-Center,Double-Blind Trial to Assess the Effectiveness~     and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing~     Percutaneous Coronary Intervention with the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER®~     Stent)~   "
199253|NCT00954694|"~     The purpose of this research study is to determine if participation in a fifteen week~     introductory exercise regimen using the NuStep by sedentary adults diagnosed with Type 1 or~     Type 2 diabetes will affect exercise adherence and lifestyle adjustment. This study will~     examine if using the NuStep encourages participants to seek other modes and facilitates~     interest in exercise. Age, gender, weight, height, waist-to-hip ratio, heart rate, blood~     pressure, 6-minute walk test, and A1C will be recorded pre, mid-point, and post-test. During~     each NuStep exercise session heart rate, blood pressure, blood glucose level, oxygen~     saturation, METs, and the Borg rate of perceived exertion will be monitored.~      Associations between NuStep use and exercise adherence are investigated through the following~     hypothesis and null hypothesis. There is an association between using the NuStep as an~     introductory exercise regimen by sedentary adults diagnosed with Type 1 or Type 2 diabetes~     and exercise adherence. The null hypothesis states there is no association between using the~     NuStep as an introductory exercise regimen by sedentary adults diagnosed with Type 1 or Type~     2 diabetes and exercise adherence. The primary endpoint of the study is the qualitative~     measurement, by use of a questionnaire, of attitude and interest toward exercise in~     participants by assessing if they choose to seek and perform other modes of exercise.~     Secondary endpoints are the quantitative measurement of the change in weight, waist-to-hip~     ratio, heart rate, blood pressure, 6-minute walk test, and A1C levels.~   "
199254|NCT00954681|"~     Marijuana is the most commonly used illicit drug in the United States. However, the treatment~     options for cannabis dependence are limited; notably, no effective pharmacotherapy has been~     developed. Conceptually, the ideal medication treatment for cannabis dependence would:~        1. be safe when administered to patients actively using cannabis~        2. reduce cannabis intake and promote abstinence~        3. treat the symptoms of cannabis withdrawal~        4. reduce craving and relapse risk~        5. have a low abuse liability.~   "
199255|NCT00954668|"~     Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany~     per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The~     currently available evidence led to current guideline recommendations that a systematic~     approach of immediate angiography in NSTEMI patients stabilized with contemporary~     antiplatelet treatment is not mandatory. However, this immediate invasive approach is~     appealing because it allows treating the underlying cause (the plaque rupture) as early as~     possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL~     NSTEMI trial we test an immediate invasive approach (<2 h) with an approach 12-72 h according~     top guidelines with respect to 6 months death and mortality.~   "
199256|NCT00954655|"~     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer~     may help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at tumor samples in patients undergoing treatment for~     gastrointestinal stromal tumors on clinical trial ACOSOG-Z9001.~   "
199257|NCT00954642|"~     This is a Phase Ib, open-label, dose-escalation study of MNRP1685A given by intravenous (IV)~     infusion as therapy for locally advanced or metastatic solid tumors.~   "
199258|NCT00954629|"~     The purpose of the study is to demonstrate the superiority of topically administered 2PX~     versus placebo (vehicle) control in terms of reduction in pain intensity and physical~     function.~   "
199259|NCT00954616|"~     In each of the 7 French areas that should be involved, patients aged 75 years and over from~     three different sectors will be included: the geriatric consultation unit (60%) and two kinds~     of nursing homes, private (20%) and state (10%). Outpatients will be included in~     chronological order; patients in nursing homes will be included at random. The patients and~     their families will be asked about the treatments received on the day of inclusion. The~     inclusion period will extend over a year. The investigating practitioners will be asked to~     fill in a questionnaire reporting the main clinical data, adverse effects occurrence, and~     information on the treatment given.~   "
199260|NCT00954603|"~     The purpose of this study is to determine whether quetiapine, and haloperidol are effective~     and safe in the treatment psychiatric symptoms in patients with delirium.~   "
199261|NCT00954590|"~     The purpose of this study is to determine if Dimebon is safe and effective in patients with~     moderate to severe Alzheimer's disease.~   "
199262|NCT00954577|"~     This study examines risk factors for type 2 diabetes in children representing multiple~     discrete ethnic groups. It also examines the short term effects of school-based health~     education supervised exercise on metabolic risk factors for type 2 diabetes mellitus in~     children. The investigators hypothesize that exercise and health education will significantly~     improve insulin sensitivity in all children, especially in children who are already insulin~     resistant, thereby lowering the risk that they will go on to develop type 2 diabetes~     mellitus. The specific hypotheses being tested are:~        1. Insulin resistance will be most evident in overweight children while an impaired ability~          of the pancreas to release insulin will be most evident in children with a family~          history of type 2 diabetes mellitus.~        2. Exercise will significantly improve insulin resistance (as measured by the fasting~          glucose/insulin ratio) with little effect on insulin secretory capacity in children.~        3. Participation in a school-based health, nutrition, and exercise education program will~          have long term beneficial effects on health related behaviors and on insulin resistance~          in all children, regardless of their level of diabetes risk.~   "
199263|NCT00954564|"~     RATIONALE: Gathering information over time about joint pain and stiffness from postmenopausal~     women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors~     plan treatment and help patients live more comfortably.~      PURPOSE: This observational epidemiologic cohort is designed to study arthralgia,~     patient-reported outcomes, and medication adherence in postmenopausal women with early-stage~     breast cancer who are receiving aromatase inhibitors.~   "
199264|NCT00954551|"~     Systemic inflammatory response syndrome (SIRS) is characterized by changes in body~     temperature, heart rate, respiratory rate, or peripheral blood white cell count, and is often~     a heralding manifestation of blood infection (ie., sepsis or bloodstream infection). SIRS~     however can occur as a result of a stroke without sepsis. When SIRS occurs after stroke,~     patients are subjected to blood cultures and tests to exclude sepsis, and are often~     empirically treated with antibiotics potentially leading to a serious gastrointestinal~     infection called C. difficile enterocolitis, and bacterial antibiotic resistance. Development~     of a blood test that could provide sufficient sensitivity to exclude blood infection in~     stroke would therefore prevent numerous tests, cultures, antibiotics, and costs. In recent~     years, there has been increasing evidence that procalcitonin (PCT) may serve as diagnostic~     marker to distinguish between infectious and non-infectious SIRS. The investigators~     hypothesize that PCT can differentiate SIRS after stroke into patients with infection and~     those without infection. Such screening tests would provide crucial information to clinicians~     that could improve patient care by reducing the number of tests and antibiotics used, as well~     as antibiotic-related infections, bacterial resistance and hospital costs.~      Hypothesis: The investigators hypothesize that PCT can be used to define normal (SIRS without~     infection) and abnormal values SIRS with infection (i.e., blood, lung, urinary, spinal fluid)~     in a population of patients with aneurysmal subarachnoid hemorrhage (SAH).~      Specific Aim 1.) To establish normal values of PCT in patients with aneurysmal subarachnoid~     hemorrhage and SIRS.~      Specific Aim 2.) Derive the sensitivity and positive predictive value of abnormal PCT values~     in patients with aneurysmal SAH, SIRS with true systemic infection.~   "
199265|NCT00954538|"~     This study will estimate the radiochemical and radiation safety and assess the efficacy of~     [18F]MK-3328, a novel positron emission tomography (PET) tracer. The study safety hypotheses~     will test whether [18F]MK-3328 is sufficiently safe and well-tolerated, based on an~     assessment of clinical and laboratory evaluations and adverse experiences in healthy~     participants, including healthy elderly (HE) participants, and Alzheimer's disease (AD)~     participants, to permit continued investigation. The study efficacy hypothesis will test~     whether [18F]MK-3328 can discriminate between AD participants and cognitively normal elderly~     control participants based on tracer volume of distribution, or one of its surrogates, in~     brain posterior cingulate gyrus.~   "
199266|NCT00954525|"~     Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis~     with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging~     (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation~     therapy. Full inclusion/exclusion criteria are available. History and physical examination,~     and laboratory and imaging analyses will be done within 14 days prior to registration. The~     three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid,~     three times per week for 8 weeks. Subjects will also have co-administration of the~     chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9~     to 18 participants will be enrolled in this Phase I study.~   "
230852|NCT00534807|"~     The purpose of this study is to test how vinflunine interacts with rifampin in the human body~   "
199267|NCT00954512|"~     This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label study designed~     to evaluate the safety and tolerability of robatumumab (SCH 717454, MK-7454) in combination~     with standard treatment in participants with advanced solid tumors to be conducted in~     conformance with Good Clinical Practices.~      Six different treatment regimens will be investigated in combination with robatumumab.~      The study will be divided into two parts. Part 1 will consist of initial safety evaluation~     and dose-finding of robatumumab in combination with each treatment regimen. Part 2 will~     consist of an expansion of each robatumumab regimen at a newly established dose level, to~     better define safety, tolerability, and initial efficacy in specific target populations.~   "
199268|NCT00954499|"~     The aim of this study is to answer the following question: In healthy infants aged four to~     six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis,~     inactivated poliovirus and Haemophilus influenzae type B (DTaP-IPV-Hib) and pneumococcal~     conjugate vaccine (PCV) while receiving a combination of proven analgesic interventions~     (least painful injection technique, holding by parent, and oral sucrose solution) and~     non-procedural talk by the parent, does the addition of rubbing near the site of injection~     reduce pain as measured by the Modified Behavioral Pain Scale (MBPS) to a greater extent than~     no rubbing?~   "
199269|NCT00954486|"~     The primary objective of this study is to assess the ability of epoetin alfa to raise~     hemoglobin (Hb) levels in elderly outpatients with unexplained anemia. The secondary~     objectives of this study are to assess the ability of epoetin alfa to improve physical~     function; cognitive function; and quality of life, and to assess the safety of epoetin alfa~     in the study population.~   "
199270|NCT00954473|"~     This research trial studies blood samples from patients with osteosarcoma. Studying the genes~     found in samples of blood from patients with osteosarcoma may help doctors identify~     biomarkers related to the disease.~   "
199271|NCT00954460|"~     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme~     glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside~     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ~     system dysfunction. The purpose of this treatment protocol is to observe the safety of~     velaglucerase alfa in patients with type 1 Gaucher disease who are either treatment naive~     (newly diagnosed) or who are currently being treated with the Enzyme Replacement Therapy~     (ERT) imiglucerase.~   "
199272|NCT00954447|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and~     longer) in combination with basal insulin in patients with type 2 diabetes mellitus with~     insufficient glycaemic control.~   "
199273|NCT00954434|"~     Fifty healthy human subjects are randomized to not to consume any alcohol at all or to drink~     1 glass of red wine/day for women or 2 glasses for men for three months. Outcomes are changes~     in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body~     composition.~   "
199274|NCT00954421|"~     The purpose of this research study is to:~        1. Determine whether deep brain stimulation (DBS) with two leads (very thin coiled wires)~          placed unilaterally (on one side of the brain) is beneficial to patients with multiple~          sclerosis (MS) tremor.~        2. Compare the two different locations of the DBS lead placement in effectiveness for~          treatment of muscle tremors that do not respond to treatment with medication caused by~          multiple sclerosis.~        3. Evaluate any side effects that may result from the two DBS leads.~   "
199275|NCT00954408|"~     The purpose of this study is to determine how common fatigue and sleepiness are in patients~     with dystonia.~   "
199276|NCT00954395|"~     The purpose of this study is to evaluate the efficacy and safety of a standardized procedure~     to establish the optimal duration of anticoagulation in patients with venous thromboembolism.~   "
199277|NCT00954382|"~     Previous foreign studies revealed that the IQ in Down syndrome (DS) declines with age, but~     not any investigation of domestic data in Taiwan was available. Individuals with DS are~     characterized by limited verbal development, and in this article, authors look into the~     diverging verbal-nonverbal abilities in the DS phenotype.~   "
199278|NCT00954369|"~     PHASE: Phase 0, Exploratory Study~      OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection~     of PET/CT imaging data, to acquire experience to improve study design and the conduct of~     future studies.~      DESIGN: Exploratory, open label, non-randomized, multi-center study.~      DURATION: Three visits - one screening, one imaging, and one follow-up visit at 24 hours~     post-dose~      PROCEDURES: Informed consent, collection of demographic information and medical history,~     administration of mental status exam, physical examination, vital signs, 12-lead ECGs,~     routine blood tests to assess major organ functions, complete blood counts and clinical~     chemistries for safety, dosing with [F-18]W372, PET imaging scans of brain (in sixteen~     subjects), whole body PET imaging and urine collections for dosimetry evaluation (in four~     subjects only), observation and interviews following imaging to collect adverse events.~      SUBJECTS: Twenty (20) subjects ≥ 55 years old:~      Group 1 will consist of 10 subjects who have a low probability of being currently positive~     for Alzheimer's Disease (AD) as defined by the protocol criteria (MMSE ≥ 28). Four of the 10~     subjects will undergo whole body PET imaging for dosimetry evaluations, and 6 of the 10~     subjects will undergo PET imaging of the brain only.~      Group 2 will consist of 10 subjects who have a high probability of currently being positive~     for AD as defined by the protocol criteria (MMSE < 24); these 10 subjects will undergo PET~     imaging of the brain only.~   "
199279|NCT00954356|"~     The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain~     following third-molar/wisdom tooth extraction.~   "
199292|NCT00954174|"~     This randomized phase III trial studies paclitaxel and carboplatin see how well they work~     compared with paclitaxel and ifosfamide in treating patients with fallopian tube, or~     peritoneal cavity cancer that is newly diagnosed, persistent, or has come back (recurrent).~     Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether~     paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients~     with uterine, ovarian, fallopian tube, or peritoneal cavity cancer.~   "
200507|NCT00938236|"~     This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the~     prevention of chronic rejection in lung transplant recipients.~   "
199280|NCT00954343|"~     Extracorporeal Shock Wave treatment is a well established treatment in orthopedics.~     Considerable success has been reported after treatment of various soft tissue pathologies~     (Tendinitis, heel spur etc). In recent years, encouraging results have been reported~     concerning the effect of the shock-wave on chronic wounds. It has been reported that healing~     time can be considerably shortened if shock-waves are applied to the wound in addition to~     conventional wound treatment. Yet, randomized, controlled, prospective trials are missing.~      In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed.~      The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with~     a different protocol). One group serves as an untreated control group. All groups get~     standardized wound treatment and wound dressing.~      That shock-wave application protocol that shows the best results (rate of completely healed~     ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned,~     two-armed, randomized controlled trial (RCT).~   "
199281|NCT00954330|"~     The aim of this prospective randomized controlled trial was to compare the effectiveness of~     surgical and conservative treatment in acute lateral ligament injury of ankle. The more~     detailed aims were to assess the function, physical activity level, re-injuries, objective~     stability and radiographic changes seen by magnetic resonance imaging in patients randomized~     to surgery or to functional treatment after a mean of 14 years follow-up.~   "
199282|NCT00954317|"~     The investigators wish to compare the analgesia provided by epidurals placed high in the~     lumbar spine versus epidurals place low in the lumbar spine.~   "
199283|NCT00954304|"~     The purposes of this study are to investigate the duration of P-glycoprotein inhibition after~     oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK~     tablet.~   "
199284|NCT00954291|"~     The objective of the study is to characterize the pharmacokinetic profile of granisetron~     patch after single administration to healthy subjects.~   "
199285|NCT00954278|"~     The purpose of this study is to determine the number of patients with advanced, relapsed~     non-small cell lung cancer who can tolerate dose escalation sorafenib from 400 mg twice daily~     to either 600 mg twice daily or 800 mg twice daily. Safety and tolerability of sorafenib will~     also be examined.~   "
199286|NCT00954265|"~     To access whether the ovulation triggering with rec-HCG instead urinary-HCG has any impact on~     the blastulation rate and pregnancy rate of patients undergoing IVF treatment~   "
199287|NCT00954252|"~     The purpose of this study is to evaluate the safety and tolerability of single oral doses of~     CHF 5074 in young healthy male volunteers.~   "
199288|NCT00954226|"~     The goal of this clinical research study is to learn the effects of the standard dose of~     erlotinib and the higher dose of erlotinib on biomarker levels in patients with head and neck~     cancer. Biomarkers are chemical markers in the blood and/or tissue that may be related to~     your response to the study drug. The safety of the drug will also be studied.~   "
199289|NCT00954213|"~     Thirty eight autistic spectrum disorder children age 2-6 years recruited into the study. The~     new treatment intervention is based on the DIR Model. Parents will be coached at the start~     and then every 3-4 months for 1 year. Outcome will be measured at the first session and at~     the end of the study using Functional Emotional Assessment Scale and Childhood Autism Rating~     Scales, Functional Emotional Level, and parent satisfaction rating.~      Hypothesis of the study: Children who get additional treatment of DIR/floortime show much~     improvement in climbing the developmental ladder and declining in the autistic behaviors.~   "
199290|NCT00954200|"~     Scientific background: Bronchoscopy is a procedure commonly performed in the management of~     persistent respiratory illness. In the last decades this exam has become a routine and safe~     procedure even in children and there are few side-effects. However, one known side effect is~     transient fever and even high fever a few hours after the bronchoscopy. This side effect is~     not dangerous but very uncomfortable for the patients and it would be interesting to try to~     reduce this phenomena. This fever is due to a release of cytokines during the~     broncho-alveolar lavage procedure and not to sepsis. In a previous study a single dose of~     dexamethasone was shown to prevent the fever post bronchoscopy with no apparent detriment to~     the child. It is well known that steroids are immunosuppressive. Even though the~     post-bronchoscopy fever is not caused by an infection, it seems preferable to use other~     anti-inflammatory drugs to fight this very inconvenient side effect.~      Ibuprofen (Nurofen*) is known as an effective medication to reduce fever in infectious~     illnesses and is even considered as superior to paracetamol. It has no immunosuppressive~     effect and is usually well tolerated by children with very few side effects when taken in the~     normal therapeutic dose of 10mg/Kg. The investigators postulate that a dose of Nurofen prior~     to bronchoscopy could significantly reduce fever post bronchoscopy.~   "
199291|NCT00954187|"~     Purpose: To compare the efficacy of oral gabapentin and its newer analogue pregabalin in~     postoperative pain control after photorefractive keratectomy (PRK).~      Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one~     or both eyes will be randomized into one of two treatment groups. Those in group A will be~     treated with gabapentin, and those in group B will be treated with pregabalin to control~     postoperative PRK pain. Patients in both groups will begin treatment two hours prior to~     surgery in order to achieve therapeutic blood levels of each medication. After surgery the~     patients will assess their pain level using the visual analogue scale (VAS) at different~     intervals of time - one hour after surgery, the evening of the surgery, and three times each~     day for three subsequent days. Patients will also daily assess their level of somnolence~     using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness for the same~     amount of time. On the fourth day they will return to clinic for a postoperative appointment.~     At that time the pain, sleepiness, and dizziness assessment scales will be collected and~     analyzed. The patients will return one month later to further assess long-term pain and~     healing after PRK.~      Results: Both gabapentin and pregabalin have been shown in previous studies to treat~     postoperative pain effectively. The effects of gabapentin 300 mg TID for 3 days versus~     pregabalin 50 mg TID for 3 days on decreasing overall postoperative pain following PRK will~     be presented.~      Conclusion: The effectiveness of the two different treatment medications will be analyzed,~     and the conclusion will be based on the results.~   "
199293|NCT00954161|"~     The objective of this study is to measure the effect of an innovative training programme on~     the help seeking behaviour and helping rates of bystanders in medical emergencies.~   "
199294|NCT00954148|"~     This is a comparison, at this VA Hospital,of routine multi-visit and multi-testing for solid~     tumor recurrence in four tumor groups to a limited scheduled 5 visit history/physical with~     PET/CT only, over a five year period. The purpose is to show through utilization of the~     single most sensitive and specific test currently available-PET/CT-that survival for patients~     in follow-up can be improved.(Plus lowering medical costs and increasing patient confidence~     and compliance with follow-up appointments).~   "
199295|NCT00954135|"~     Endocrine therapy is the mainstay of systemic treatment in patients with endocrine responsive~     breast cancer. Aromatase inhibitors are the most active agents in post-menopausal women.~     Randomized comparisons either in primary/adjuvant setting or in metastatic disease setting~     have demonstrated the superiority of these drugs over tamoxifen.~      Primary systemic treatment administered to breast cancer patients is a useful model to~     identify baseline features able to predict which patients are most likely to benefit from~     cytotoxic treatment and is a way to study new biological markers in relation to the~     predictive information they provide.~      This treatment modality represents therefore the best way to explore new treatment strategies~     in particular treatment strategies involving target therapies.~      We have conducted a randomised phase II trial in which the activity of Letrozole plus/minus~     oral metronomic cyclophosphamide as primary systemic treatment has been investigated in a~     patient population of elderly breast cancer patients. The conclusions were that the~     combination of letrozole with metronomic cyclophosphamide was a very active scheme. In~     addition this was the first study demonstrating in vivo the antiangiogenic effect of~     metronomic scheduling. This study suggests that chemotherapy administered on a metronomic~     schedule, targeting therefore the neo-angiogenesis, could be synergistic with endocrine~     therapy with aromatase inhibitors.~      Sorafenib is a multi-kinase inhibitor targeting Raf, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-alfa,~     Flt-3, c-Kit, and p38.~      There is a strong rationale of combining different anti-angiogenic agents. At the ASCO 2007~     meeting the data of a phase I study exploring the toxicity of a combination of sorafenib and~     bevacizumab have been presented. The results showed an increased toxicity being dose limiting~     in some patients. To our knowledge there are no data un activity and toxicity of adding~     sorafenib to metronomic chemotherapy.~   "
199296|NCT00954122|"~     The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR)~     tablets for 3 weeks will improve their agitation when they have acute psychosis.~   "
199297|NCT00954109|"~     The overall aim of the project is to determine whether or not exercise influences~     cardiovascular or nervous responses to meal ingestion in individuals with insulin resistance~     or type 2 diabetes.~   "
199298|NCT00954096|"~     This study will address the hypothesis that nicotine, like cigarette smoking acting as a~     pro-oxidant may have adverse effects on arterial function.~   "
199299|NCT00954083|"~     Thirty two children age 2-6 years are recruited into the study and the randomization will be~     stratified for chronological age and symptom severity into 2 main groups, intervention and~     control. The intervention group will receive an additional target treatment of DIR/Floortime~     parent training intervention, while the control group will continue on their routine care for~     3 months.~      Hypothesis: Children in the intervention group show much improvement in climbing the~     developmental ladder and declining in the autistic behaviors.~   "
199300|NCT00954070|"~     This is an observational, prospective and pilot study to determine through confocal~     endomicroscopy diagnostic microscopic features detectable at the gastroesophageal junction of~     patients with non-erosive gastroesophageal reflux disease.~      The hypothesis is that minimal mucosal changes occur in non-erosive gastroesophageal reflux~     disease. Although these minimal changes are not always visible on white-light endoscopy, it~     is detectable using high-resolution confocal endomicroscopy and these confocal features are~     diagnostic of non-erosive reflux disease (NERD).~   "
199301|NCT00954057|"~     This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.~   "
199302|NCT00954044|"~     The purpose of this study is to explore the benefits of Exercising Together-a partnered~     strength training program for married couples coping with prostate cancer- on the physical~     and emotional health of prostate cancer survivors and their spouse and on marital quality.~   "
199303|NCT00954031|"~     Analyze in children and adults, risk factors in the onset of the APA. The main hypothesis~     focuses on the use of anti-inflammatory in the context of pharyngitis or sore throat before~     the symptoms of ABS. Secondary objectives:~        1. - Analyze the implementation of a rapid diagnostic test and its result on the occurrence~          of an ABS~        2. - Measure the frequency of prescription and describe the reasons for not prescribing an~          antibiotic for patients who consulted for a sore throat and having developed a PLA~        3. - Describe the microbial flora could puncture of patients hospitalized for APA~   "
199304|NCT00954018|"~     Scientist have begun to realize that many types of bacteria often live together as a complex~     community, and the investigators wish to apply that idea to the bacteria in the respiratory~     system of people with Cystic Fibrosis (CF). It is possible that the survival of the many~     millions of bacteria in the CF lung depends on the production of special chemicals that might~     be made only by very few types of bacteria. If that is true, medicines that interfere with~     those chemicals could treat the lung infections that cause trouble for nearly all people with~     CF. The investigators wish to study the production of several potentially critical chemicals~     by the respiratory bacteria and to examine the effect of those chemicals on the makeup of the~     entire community of bacteria. To detect all the bacteria in that community, the investigators~     will use new methods that use bacterial genetic information and can detect hundreds of~     different types of bacteria in respiratory samples of individual CF patients.~   "
199305|NCT00954005|"~     The purpose of the phase I part is to determine the tolerability, the initial safety profile~     and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent~     lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine~     and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent~     lymphoma.~   "
199306|NCT00953992|"~     -  To investigate the etiology, epidemiology and prognostic factors of acute kidney injury.~        -  To find out risk factors that relate with the prognosis of acute kidney injury,focusing~          on inflammation, oxidative stress and nutritional status.~        -  To study on the relationship between gene polymorphism and prognosis of acute kidney~          injury.~   "
199307|NCT00953979|"~     This is a prospective randomized controlled study to evaluated the efficacy and safety of~     kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major~     outcome index is proportion of patients achieving ASAS20 response at week12, and minor~     outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events~     at any time were recorded to evaluate the safety.~   "
199308|NCT00953966|"~     Starches from genetically modified potatoes, which differed in terms of amylose, amylopectin~     and phosphate content, were tested in a human randomized controlled trial.~   "
245103|NCT00345696|"~     The purpose of this study is to determinate progression free survival after 9 months of~     treatment.~   "
199309|NCT00953953|"~     Heart failure has become one of the major epidemics of the modern era. Despite optimal~     standard drug therapy, the prognosis of patients with heart failure remains poor. Patient~     with Heart Failure are prone to have dyssynchrony which means that there are electrical~     disturbances that cause the heart to pump blood in an inefficient way. Ventricular~     dyssynchrony has been associated with increased mortality in patients with heart failure.~     Based on these observations, techniques have been developed to correct dyssynchrony. The~     investigators propose to investigate the change of dyssynchrony in relation to intravascular~     volume status and exercise in heart failure patients. The investigators also propose to~     examine dyssynchrony in the setting of acutely decompensated heart failure. The change in~     dyssynchrony will be followed to examine if it translates into clinical significance.~   "
199310|NCT00953940|"~     The purpose of this study is to measure the acute renal dysfunction on the first, second,~     seventh and twentieth days.~   "
199311|NCT00953927|"~     This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity~     and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without~     tuberculosis or HIV infection. This study planned to enroll 2784 infants (126 to 182 days of~     age) who received study vaccine or control and were followed for 15 - 36 months. The study~     was conducted at a single site in South Africa.~   "
199312|NCT00953914|"~     The purpose of the study is to determine if pyridostigmine bromide improves heart rate~     variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.~   "
199313|NCT00953901|"~     Blood clotting abnormalities or problems that happen during surgery ? even minor surgery ?~     are serious because of the possibility of serious bleeding that cannot be stopped. The~     current standard practice for people with clotting abnormalities is to transfuse additional~     blood before the surgery, in an effort to decrease bleeding problems. However, transfusing~     blood before the surgery is not very effective in decreasing bleeding complications. In~     addition, it may be associated with other complications, including fluid buildup and swelling~     in the lungs. For this study, a person with a mild clotting problem is defined as one with an~     INR (International Normalized Ratio) between 1.5 and 3. Severe clotting is defined as an INR~     greater than 3. This study will aim to test if limiting or restricting transfusion for those~     patients with severe clotting problems (an INR greater than 3) will result in fewer~     transfusion problems and fewer unnecessary transfusions in comparison with the current, more~     liberal, transfusion use for all patients with both mild and severe clotting problems (an INR~     greater than 1.5).The investigators will also determine if liberal blood transfusion~     decreases the risk of bleeding after surgical procedures.~   "
199314|NCT00953888|"~     The purpose of this study is to determine how well tolerated and safe AZD5069 is at different~     dose levels in healthy male and/or females. The study will also investigate how quickly~     AZD5069 is absorbed into and cleared by the body.~   "
199315|NCT00953862|"~     Although Attention Deficit/ Hyperactive Disorder (ADHD) is a common comorbidity in~     individuals diagnosed with Substance Use Disorder (SUD), little data currently exists on the~     utility of screening tools in large samples of adult patients with SUD in inpatient~     treatment. This was a 10-week, 2-phase, open label trial of atomoxetine for ADHD in adult~     patients being treated for a co-morbid SUD in a residential treatment facility (RTF). The~     primary objective of the study was to assess the efficacy of atomoxetine in adults with an~     SUD and ADHD. Secondary objects included assessment of the co-morbidity of ADHD and the~     safety and tolerability of atomoxetine in this population.~   "
199316|NCT00953849|"~     The poor survival of Veterans with oral cancer underscores the significance of identifying~     new treatment approaches. The proposed studies will test a new 2 pronged immunotherapeutic~     approach for oral cancer patients which lessen the immune inhibitory environment while~     maturing cells that can stimulate T cell reactivity against oral cancer cells.~   "
199317|NCT00953836|"~     The purpose of this study is to investigate the kinetics of two known alkylresorcinol~     metabolites in human subjects after intake of high-fiber rye bread. Whole grain rye is the~     most abundant source of alkylresorcinols.~   "
199318|NCT00953823|"~     Patients with heart failure are at an increased risk for thiamin deficiency (TD), for many~     reasons such as malnutrition and the use of diuretic drugs. Thiamin is a B vitamin that plays~     an important role in the production of energy in body. Therefore, low levels of thiamin may~     limit the amount of energy available for the heart to pump blood. Recent thiamin~     supplementation trials have demonstrated significant improvements in heart function. However,~     while clinically important, the results of these studies are limited by their small sample~     sizes, indirect measurement of thiamin status and reliance on hospitalized patients.~     Therefore, the investigators' goal is to determine the prevalence of thiamin deficiency in~     ambulatory patients with heart failure by direct measurement of thiamin in red blood cells.~   "
199319|NCT00953810|"~     The main aim of this randomized study was to evaluate the effect of educational intervention~     on patients with heart failure and their care-giver with regard to patients' prognosis.~   "
199320|NCT00953797|"~     High Blood Pressure or Hypertension is one of the main causes of stroke, heart disease, heart~     attack and kidney disease. Traditionally physicians use diet and lifestyles change and~     medications to control patient's blood pressure. There are however, some patients whose blood~     pressures are difficult to control and their blood pressure remains elevated despite multiple~     medications. When blood pressure remains above goal (greater then 140/90 or greater then~     130/80 mmHg in patients with diabetes or kidney disease) despite 3 or more blood pressure~     medications, the investigators call it Resistant Hypertension.~      Enhanced External Counterpulsation (EECP) is a new method of treatment currently used in~     people with heart disease and chest pain. EECP therapy uses three sets of balloon like cuffs~     that are wrapped to the calves, lower thighs, and upper thighs. These cuffs inflate and~     deflate with every heart beat, causing increased blood return to the heart and better blood~     flow. It has also been found to improve the function of endothelial cells, a type of cells~     that lines the wall of blood vessel through out the body which helps to regulate and maintain~     blood pressure. This leads us to believe that EECP therapy, although not used at present for~     treating patients with Resistant Hypertension, may be useful in decreasing blood pressure.~   "
199321|NCT00953784|"~     This is a comparison, at this VA Hospital, of standard operating room management in~     colorectal surgery to a more rigid management using an additional five previously tested~     treatments to determine if this changes the rate of post operative wound infections.~   "
199324|NCT00953745|"~     Aripiprazole has been approved by the FDA for augmenting ineffective/partially effective oral~     antidepressant therapy in patients suffering from major depression. The mechanism by which~     this augmentation is achieved is not known. This study has been designed to test the~     hypothesis that the primary mechanism of action of aripiprazole (ARP) antidepressant~     augmentation is through the dopaminergic pathway. Two positron emission tomography (PET) scan~     procedures and a functional magnetic resonance imaging (fMRI) scan will be used to test this~     hypothesis.~   "
199325|NCT00953732|"~     This study is designed to follow up patients who have achieved complete clearance of AK~     lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12~     month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety~     in the selected treatment area.~   "
199326|NCT00953719|"~     This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to~     evaluate artificial hips with a 28 mm ceramic head and liner to determine whether they~     perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.~      This arm of the study is designed to compare a 36 mm ceramic head and sleeve with a subset of~     the control (28mm ceramic head and a polyethylene sleeve) from the original study (G030075)~     (NCT#00208507) with additional follow-up, to determine if they perform as well.~   "
199327|NCT00953706|"~     The purpose of this study was to evaluate the safety and efficacy of ivacaftor in~     participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous~     for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent~     and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR~     protein. Potentiators are pharmacological agents that increase the chloride ion transport~     properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent~     protein kinase A (PKA) activation.~   "
199328|NCT00953693|"~     Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically~     reprogrammed to an embryonic stem cell-like state by being forced to express genes and~     factors important for maintaining the defining properties of embryonic stem cells. The~     reprogramming of adult cells into embryonic stem (ES) cells enables the generation of~     patient-specific stem cells and thus has enormous potential for the treatment and analysis of~     degenerative diseases. In this project the investigators are going to induce pluripotent stem~     cells from cell cultures from skin biopsies of patients. The iPS cells will be developed for~     modeling diseases and drug discovery as well as basic research.~   "
199329|NCT00953680|"~     This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ)~     combination tablet and coadministration of losartan and hydrochlorothiazide.~   "
199330|NCT00953667|"~     The purpose of this study is to determine genetic factors that affect responses to niacin~     therapy and endotoxemia in healthy volunteers.~   "
199331|NCT00953654|"~     The purpose of this study is to compare the effects of 6 weeks of endurance or strength~     training and a wait list comparison condition on symptoms of Generalized Anxiety Disorder~     (GAD).~   "
199332|NCT00953641|"~     The purpose of this study is to determine whether using Misoprostol vaginally before an~     office endometrial biopsy is performed, will make it easier, more successful and less painful~     to do the procedure.~      The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial~     biopsy will increase the ease of performing office endometrial biopsy by reducing the need to~     use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.~   "
199333|NCT00953628|"~     The purpose of this study is to investigate any potential advantages of replacing human~     chorionic gonadotropin (uhCG) with recombinant human chorionic gonadotropin (recHCG) for~     final oocyte maturation with regard to Ovarian hyperstimulation syndrome~     (OHSS)pathophysiology, endometrium receptivity and embryo quality and clinical pregnancy.~   "
199334|NCT00953615|"~     The purpose of this study is to determine the safety and benefit of Thalidomide with primary~     sclerosing cholangitis (PSC). This is a six month study.~   "
199335|NCT00953602|"~     In this study the effects of genetically modified potatoes on the human metabolism will be~     observed. Healthy volunteers receive for one week muffins, produced with starch from a~     genetically modified potato or with a normal available starch, in a randomized trial.~   "
199336|NCT00953589|"~     The purpose of this 12-week study was to assess in subjects with chronic hepatitis C~     (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic~     response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5~     ug/kg PEG-Intron™ dosed weekly.~   "
199337|NCT00953576|"~     The purpose of this research study is to determine the safety of giving ketoconazole,~     hydrocortisone and dutasteride (KHAD) with lapatinib. The investigators believe that there is~     evidence in castrate resistant prostate cancer that two growth factor receptors (EGFr and Her~     2 /neu )are increased in prostate cancer cells. Both these receptors are turned off by the~     drug lapatinib. By adding lapatinib to this trial, the investigators hope that the~     investigators can turn off the signaling from the receptors and therefore make the~     participant's cancer more responsive to KHAD treatment.~   "
199338|NCT00953563|"~     The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and~     compare its performance with the standard of care, compression therapy alone for the~     treatment of venous leg ulcers.~   "
199339|NCT00953550|"~     Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs~     of stomach content. It is typically used in acute settings that require acute surgery or in~     prehospital settings, but also in specific risk patients requiring elective surgery. The~     reason for conducting rapid sequence intubation is to minimize the risk of pulmonary~     aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid~     sequence intubation is a procedure with a high risk of complications in itself. The time~     period from induction of anaesthesia to intubation is particularly risky, because the patient~     is apneic. This study addresses this problem by investigating, how quickly spontaneous~     respiration can be reestablished after a rapid sequence intubation when using~     Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended~     to establish a sample size for the full protocol.~      Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter~     when using Rocuronium/Sugammadex compared to Succinylcholine.~   "
209076|NCT00824317|"~     The purpose of this study is to compare the response to methylphenidate treatment of children~     with two different subtypes of ADHD.~   "
199340|NCT00953537|"~     RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused~     by capecitabine may help doctors plan better treatment.~      PURPOSE: This clinical trial is studying blood samples in predicting response to capecitabine~     in women with metastatic breast cancer.~   "
199341|NCT00953524|"~     The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic~     vaccine.~      Primary Objectives:~        -  To describe the immunogenicity of the candidate vaccines after each injection.~        -  To describe the safety of the candidate vaccines after each injection.~   "
199342|NCT00953511|"~     RATIONALE: The prognosis of patients with advanced esophageal cancer may be improved by~     preoperative chemoradiation. But only those patients have a benefit from this additional~     therapy, whose tumor shows a response after chemoradiation. Molecular markers may help to~     identify before starting the therapy those patients who response.~      PURPOSE: This is the first prospective, clinical trial to study the impact of ERCC1 to~     predict histopathological response to neoadjuvant radiochemotherapy (RTx/CTx) in patients~     with cancer of the esophagus.~   "
199343|NCT00953498|"~     HDL from patients with type 2 diabetes show a significant reduction of their~     endothelium-dependent vasodilatory effect.~      The primary objective of the study is to analyze whether treatment with glitazones~     (pioglitazone and rosiglitazone)may improve the endothelium-dependent vasodilatory effect of~     HDL lipoproteins in patients with type 2 diabetes.~      The secondary objectives are:~        -  to analyze the effect of glitazone treatment on phospholipase A2~        -  to look for possible differences between the effects of pioglitazone and those of~          rosiglitazone~        -  to analyze the glycemic response to glitazone therapy according to clinical and~          biological baseline characteristics.~   "
199344|NCT00953485|"~     This study will explore safety and efficacy of allogeneic mesenchymal stem cells~     transplantation (MSCT) to treat patients with diagnosis of primary Sjögren's Syndrome (pSS)~     who have been resistant to multiple standard treatments. The underlying hypothesis is that~     the pSS condition is caused by an abnormal immune homeostasis that can be restored by MSCT.~   "
199345|NCT00953472|"~     The investigators working hypothesis is that human hypertension is in part due to a~     derangement in the endocrine function of the heart - a primary or secondary mechanism -~     resulting in a relative deficiency of the natriuretic peptides (NP). The remodeled~     hypertensive heart could result in altered processing and degradation of B-type NP resulting~     in altered molecular forms with decreased biological activity. The investigators further~     hypothesized the chronic administration of BNP in subjects with hypertension, is feasible,~     safe and will induce a sustained reduction in blood pressure.~   "
199346|NCT00953459|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients~     with small cell lung cancer.~   "
199347|NCT00953446|"~     The purpose of this study is to assess magnetic resonance imaging (MRI) as a tool to track~     tumor growth for renal cell carcinoma while participants are on clinical treatment therapy of~     sunitinib and AMG386. An MRI is a type of scan that uses powerful magnets to make clearer~     images or to focus on detailed medical information in the abdomen and pelvis. The imaging~     done for this study will use the arterial spin labeling (ASL) MRI technique that allows us to~     see blood flow changes which possibly may indicate changes in tumor growth. Participants will~     be on a clinical trial for the treatment.~   "
199348|NCT00953433|"~     This study is aimed at reducing the risk of hoarseness and damage to the vocal cords~     following general anaesthesia. Conventional endotracheal intubation with use of a stylet will~     be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is~     dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid~     sequence intubation settings the enhanced dirigibility can be crucial, which is why most~     anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with~     a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the~     conventional stylet enforced endotracheal tube.~      Study hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when~     compared to the conventional stylet enforced endotracheal tube under optimal intubation~     conditions.~   "
199349|NCT00953420|"~     Patients have a type of cancer called nasopharyngeal carcinoma (NPC) that has either come~     back or not gone away after the best known standard treatments.~      Most patients that respond to chemotherapy once their NPC tumors have come back have been~     treated with a platinum-based medication like cisplatin. However, since many patients are~     given cisplatin during their initial treatment for NPC, in this study, they will be treated~     with another platinum-based chemotherapy medicine that has been used in patients with NPC~     called carboplatin. In this study, carboplatin will be used in combination with another drug~     called docetaxel. Other studies in patients with advanced head and neck cancer have shown~     that docetaxel can cause tumors to respond better and allow patients to survive longer when~     added to the standard treatments for those diseases.~      Some patients with NPC show evidence of infection with the virus that causes infectious~     mononucleosis, known as the Epstein Barr virus (EBV), before or at the time of their cancer~     diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage~     disease, suggesting that it may play a role in causing NPC. Previously, patients have been~     treated with high-risk NPC using EBV-specific cytotoxic T cells. These cells are grown in the~     laboratory and taught to recognize and attack EBV infected cells. In the past, patients were~     either given the cells alone or just after they had received a medication to briefly lower~     their white blood cell count. In both cases, many patients had their tumors shrink and in~     some cases completely disappear after being treated with these EBV-specific cytotoxic T~     cells.~      Investigators have now decided to look at how patients with NPC and their tumors respond to~     the treatment combination of chemotherapy and EBV-CTL. Patients are being asked to~     participate in this study since the NPC tumor is associated with EBV and has either come back~     or not responded to standard treatment. This combination of chemotherapy and EBV-CTLs is an~     investigational treatment not approved by the Food and Drug Administration.~      The purpose of this study is to see how relapsed or refractory, EBV-associated NPC tumors~     respond when treated with carboplatin and docetaxel followed by EBV-CTL.~   "
199350|NCT00953407|"~     The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic~     contact lens wearers when fit with one of 5 different daily disposable contact lenses.~   "
199351|NCT00953394|"~     Well differentiated neuroendocrine carcinomas have low proliferative activity and~     conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent~     administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties.~     Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing~     metronomic chemotherapy in this clinical setting.~      A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU)~     infusion plus long-acting release (LAR) octreotide for patients with neuroendocrine~     carcinoma.~   "
199399|NCT00952718|"~     The purpose of this study is to determine whether inspiratory muscle training could improve~     and/or prevent the deterioration of inspiratory muscle strength, clinical cardiopulmonary~     outcome, systemic immunologic responses and quality of life in patients with bronchiectasis.~   "
199352|NCT00953381|"~     Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a~     randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into~     four groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of~     ilaprazole, 5, 10, and 20 mg/day, and one of omeprazole 20 mg/day as positive control. The~     primary endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its~     resolution from active to scarring stage. Symptoms relief was evaluated as secondary end~     points by using a graded score. Safety and tolerability were evaluated on basis of clinical~     assessments.~   "
199353|NCT00953368|"~     The aim of this study is to evaluate the effects of remote ischemic preconditioning on~     cognitive function in patients undergoing off-pump coronary artery bypass graft.~   "
199354|NCT00953355|"~     Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves~     hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and~     intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin~     B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus~     patients treated with metformin.~      Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if~     folate supplementation may improve endothelial structure and function in PCOS patients.~   "
199355|NCT00953342|"~     Asthma is a chronic disorder of the airways primarily driven by increased airway~     inflammation, and is an escalating medical problem in Canada. For example, between 1994 and~     2001 there was a 40% increase in the number of Canadians who had asthma. Not only is the~     prevalence of asthma increasing but there has been a rapid rise in the number of asthma~     events and costs associated with asthma and poor asthma control. It has been estimated that~     the global cost of caring for asthma exceeds that of AIDS/HIV and tuberculosis combined.~     These increases have occurred in spite of the development of clear asthma management~     guidelines. There is evidence to suggest that aerobic exercise, e.g., running or cycling, may~     improve asthma symptoms and control in children. However, there are currently no studies that~     have systematically assessed the effects of exercise on asthma control or symptoms in adults.~     The current proposed study will assess the effects of aerobic exercise in sedentary patients~     with poorly controlled asthma. In addition to usual medical care, 52 patients will~     participate in a supervised aerobic exercise program. The program will consist of 3 X 1hr~     sessions of supervised exercise per week for 12 weeks. Another 52 patients will only maintain~     usual medical care. The asthma control, quality of life, and inflammatory profile will be~     evaluated at baseline and following the 12 weeks of treatment. The investigators believe~     that: (1) The exercise intervention will significant improve asthma control and asthma~     quality of life; (2) The exercise intervention will result in significant improvements in~     inflammatory profiles; and (3) These changes in the inflammatory profile will be directly~     related to the improvements in asthma control and quality of life.~   "
199356|NCT00953329|"~     Study Status:~      Duke University Health System Institutional Review Board has received notification of study~     termination; final IRB closure date is 12/12/2008. Study enrollment is now closed.~      Enrollment Update:~      Only one subject was entered into this study out of an expected enrollment of 15 patients in~     this single site clinical trial. With no recruitment interest, the financial sponsor and~     Sponsor-PI chose to close the clinical trial.~   "
199357|NCT00953316|"~     This research study has been developed to obtain preliminary information about safe timing of~     the transition of infants from car beds to car seats, and to find out if initial failure of~     the car seat challenge is associated with small jaw size or increased respiratory illness.~   "
199358|NCT00953303|"~     Evidence showed that glucocorticoids could induce potent diuretic actions and improve renal~     functions in patients with decompensated congestive heart failure. Thus we design this study~     to determine the efficacy of glucocorticoids on cardiovascular mortality in the 30 days~     following randomization.~   "
199359|NCT00953290|"~     The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new~     indication of reduction of thigh circumference.~   "
199360|NCT00953277|"~     The purpose of this study is to determine if it is technically feasable to repair nerves that~     are injured as part of a planned surgical removal of the prostate and the surrounding tissue~     in subjects with prostate cancer. The study will also examine the long term outcomes on~     erectile function, continence and overall quality of life in the enrolled subjects.~   "
199361|NCT00953264|"~     The investigators here propose to evaluate the hormonal and metabolic effects of weight loss,~     including evaluation of changes in several tissues.~   "
199362|NCT00953251|"~     BACKGROUND: We sought to determine the diagnostic value of the new TnThs assay for early~     detection of evolving non-STEMI in patients with acute coronary syndrome and a negative 4th~     generation cTnT result on admission.~      METHODS: We evaluated several statistical patterns of blood results of TnT hs and cTnT of 115~     patients and calculated necessity of prediction of evolving non-STEMI within 6 hours.~      RESULTS: Based on the results of the 4th generation cTnT assay, an evolving non-STEMI was~     diagnosed in 26 patients, 31 were classified as unstable angina. The TnThs lead to an~     increase of non-STEMI diagnosis as compared to the 4th generation assay. We could calculate~     increased sensitivities for earlier detection of evolving non-STEMI from 61.5% on admission~     to 90.9% within 3 hours and 100% within 6 hours compared to cTnT.~      CONCLUSIONS: The TnThs assay enables earlier detection of non-STEMI and allows identification~     of an additional percentage of cases with non-STEMI previously classified as unstable angina.~   "
199363|NCT00953225|"~     Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated~     phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising~     the possibility that vitamin D deficiency over time promotes the progression of subclinical~     prostate cancer to clinical disease. The investigators propose to conduct a clinical study~     aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans~     diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease~     monitored through active surveillance. The successful completion of this proposed clinical~     study will allow us to determine whether correcting vitamin D deficiency in Veterans~     diagnosed with early-stage prostate cancer will prevent progression of their disease and~     improve their prognosis.~   "
199430|NCT00952315|"~     The investigators plan to compare three different devices that are used to break up large~     kidney stones during surgery for removal to see if one is faster or more efficient than the~     others.~   "
199364|NCT00953212|"~     Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring~     in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart~     valve repair/replacement patients. Efforts to decrease the high rates of AF have not made~     great inroads to the problem. The current standard of care is the use of preoperative and~     postoperative beta blockers. We propose to compare the use of prophylactic oral ascorbic acid~     with and without prophylactic oral amiodarone, in combination with oral beta blockers, for~     the prevention of atrial fibrillation after open heart surgery. The hypothesis is that either~     drug, or a combination of the two drugs, will be superior and safe when compared to beta~     blockers alone.~   "
199365|NCT00953199|"~     The purpose of this study is to determine if lidocaine is effective in reducing the incidence~     of post-ERCP pancreatitis.~   "
199366|NCT00953186|"~     The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers~     as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.~   "
199367|NCT00953173|"~     A prospective, international, multi-center study of clinical outcomes and estimated~     healthcare resource expenditures associated with the treatment of obesity using the LAP-BAND~     AP® Adjustable Gastric Banding System.~   "
199368|NCT00953160|"~     The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new~     indication of reduction in size of localized areas of the body.~   "
199369|NCT00953147|"~     This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group,~     efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male~     and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).~   "
199370|NCT00953134|"~     The investigators hypothesize that periconceptional iron supplementation to married,~     nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin~     concentrations before and during pregnancy.~   "
199371|NCT00953121|"~     The purpose of this study is to determine whether Bevacizumab, CPT-11 and Carboplatin in~     combination are effective in the treatment of recurrent malignant glioma.~   "
199372|NCT00953108|"~     In former studies of the investigators research group the investigators could also~     demonstrate acute inhibitory effects of the antidepressant mirtazapine on ACTH and cortisol~     release in normal controls (Schüle et al. 2002), most likely mediated via antagonism at~     central 5-HT2- and H1-receptors. In contrast to mirtazapine, serotonin or norepinephrine~     reuptake inhibiting antidepressants acutely stimulate ACTH and cortisol secretion (Schüle~     2007). The investigators also performed a study in depressed patients who were treated either~     with mirtazapine or with reboxetine using serial dexamethasone/CRH tests (week 0, 1, and 5)~     as a parameter for HPA axis activity. Mirtazapine, but not the norepinephrine reuptake~     inhibitor reboxetine was able to significantly reduce HPA axis activity already within one~     week (Schüle et al. 2006). Mirtazapine is known to have an earlier onset of antidepressant~     action than do SSRIs such as sertraline (Behnke et al. 2003) or antidepressants with dual~     mechanism of action such as venlafaxine (Benkert et al. 2006), possibly due to its rapid~     inhibition of HPA axis activity in unipolar depressed patients.~      Since mirtazapine and quetiapine have similar effects on the HPA system in healthy male~     volunteers (i.e. inhibition of ACTH and cortisol secretion), a rapid attenuation of HPA axis~     activity is also expected during quetiapine XR treatment in depressed patients.~      Therefore, in the present study the investigators goal is to investigate whether quetiapine~     fumarate XR at a dosage of 300 mg per day has an impact on HPA axis activity in unipolar~     depressed patients, as measured by serial dexamethasone/CRH tests (week 0, 1, and 5) and~     salivary cortisol profiles and whether putative effects of quetiapine XR on the HPA system~     are related to its antidepressant efficacy.~   "
199373|NCT00953095|"~     The goal of this project is to test an intervention program for caregivers and their young~     children with autism that is focused on improving social communication. This study~     specifically targets underserved populations, specifically children from low SES and~     racial/ethnic minority families. Participants will include 40 children (aged 24 months to 60~     months) and their caregivers who will be randomized (as if by flipping a coin) to one of the~     two treatments: Parent education sessions for two hours a week for 12 weeks or parent-child~     intervention sessions with the child for one hour, twice a week for 12 weeks. Young children~     with autism have difficulty with engaging in joint attention with others (e.g. pointing,~     showing. Joint attention skills are important to later development of language. Therefore,~     targeting this problem in young children may result in better language outcomes for these~     children.~      In order to examine the effects of the interventions, all participants will be complete~     cognitive, language, communication and play-based assessments prior to treatment, at the end~     of the first 12 weeks of the intervention, and post-treatment immediately following the~     intervention (approximately 2.5 to 3 hours each).~   "
199374|NCT00953056|"~     This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese~     populations. Approximately 144 participants will be enrolled and equally stratified into~     three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages~     6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted~     sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then~     participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator~     and the Ethics Review Committee will review blinded safety data and make decision based on~     their best clinical judgment to move study forward between cohorts. Duration for the entire~     study will be approximately 6-9 months.~   "
199375|NCT00953043|"~     This study is being done to evaluate the effects of lubiprostone, a drug approved and used~     for constipation, on pattern of contractions of the colon and the colon's sensitivity to~     distension.~   "
199400|NCT00952705|"~     The purpose of this study was to show that quadrivalent live attenuated influenza vaccine~     (Q/LAIV-BFS; MEDI8662) was at least as immunogenic as two different forms of the commercial~     vaccine, FluMist, by comparing the strain-specific antibody levels in the blood.~   "
199431|NCT00952302|"~     The study hypothesis is that body iron levels are important in determining the increase in~     lung blood pressure that occurs in response to low oxygen levels. The purpose of this study~     is to determine whether this is true at high altitude, where oxygen levels are low.~   "
200538|NCT00937833|"~     The purpose of this study is to determine the impact of an absorbable urethrovesical sling on~     the post-operative return of urinary continence after robot-assisted radical prostatectomy.~   "
199376|NCT00953030|"~     This project tests the cost-effectiveness of two promising evidence-based health promotion/~     behavior change interventions. The first intervention is the COACH Program, a revised version~     of the Health Enhancement Program (HEP) that has been implemented to date with older adults~     at multiple Senior Centers across the country (Leveille et al, 1998). The second is the~     web-based RealAge program which is also being implemented for older adults at multiple sites~     nationally and internationally. The Coach program combines a web-based risk assessment with~     individualized counselling. In contrast, RealAge is a totally web-based program.~      The specific hypotheses that we will test in the proposed cost-effectiveness study are shown~     below.~      Primary Study Hypotheses:~      COACH participants will experience significantly greater reductions in absenteeism,~     disability days, and healthcare use and cost at 6 and 12 months than RealAge participants.~     Participants in both the COACH and RealAge treatment groups will experience significantly~     greater reductions in absenteeism, disability days, and healthcare use and cost than control~     group participants at 6 and 12 months.~      Secondary Study Hypotheses:~      COACH participants will experience significantly greater levels of adherence to health~     promotion Action Plans and greater reduction in weight, body mass index, blood pressure and~     depression and greater increase in vitality and quality of life than RealAge participants at~     6 and 12 months. Participants in both the COACH and RealAge treatment arms will experience~     significantly better outcomes on these measures at 6 and 12 months than control group~     participants.~   "
199377|NCT00953017|"~     Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to~     colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel~     cleansing regimen in adults and to determine the benefit of adding a pretreatment medication~     to this bowel preparation. The tolerability of Miralax will hopefully improve patient~     satisfaction with colonoscopy and decrease their reluctance to be screened because of the~     uncomfortable taste and side effects of bowel preparation regimens.~   "
199378|NCT00953004|"~     The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat~     and energy digestibility in young adults.~   "
199379|NCT00952991|"~     Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to~     enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In~     addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric~     accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D).~     However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be~     administered by continuous intravenous infusion. This would be a drawback in clinical usage.~     LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and~     potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of~     LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to~     study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with~     T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of~     this compound on postprandial glucose metabolism.~   "
199380|NCT00952978|"~     Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a~     randomized, double-blind, parallel and positive-controlled trial. They were randomly assigned~     into two groups, 10 mg/day ilaprazole and 20 mg/day omeprazole, to be treated for up to four~     weeks and be seen at week 1, 2 and 4. The primary endpoint was the ulcer healing rate at week~     4. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms~     relief was evaluated as secondary end points by using a graded score. Safety and tolerability~     were evaluated on basis of clinical assessments.~   "
199381|NCT00952965|"~     The purpose of this study is to monitor the blood pressure level of the patient using a wrist~     cuff ranged 14 cm-25 cm.~   "
199382|NCT00952952|"~     Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Pregnant or~     nursing females are excluded. They can't have other untreated diarrheal conditions. Subjects~     will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects~     will be monitored weekly. A pathologist will review pre and post treatment biopsies. Subjects~     that show improvement will be followed for 4 weeks post medication.~   "
199383|NCT00952939|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This clinical trial is studying tumor samples in patients undergoing surgery or~     radiation therapy for primary melanoma of the eye.~   "
199384|NCT00952926|"~     The purpose of this study is to investigate if operation and permanent stoma can be omitted~     in patients with cancer in the lower part of the rectum.~   "
199385|NCT00952913|"~     The purpose of this study is to see if there is an effect on the pharmacokinetics of~     bosutinib when administered with lansoprazole.~   "
199386|NCT00952900|"~     With the great economic costs and traditionally poor outcomes among chronic temporomandibular~     joint and muscle disorder (TMJMD) patients, it has become important to treat patients in the~     acute state, in order to prevent these more chronic disability problems. This has been the~     goal of two past funded grant projects. Results of the initial project isolated risk factors~     that successfully predicted the development of chronicity with a 91% accuracy rate. A~     statistical algorithm was developed which was used in the second project to screen out~     high-risk patients. These patients were then randomly assigned an early intervention or~     non-intervention group. One-year follow-up evaluations documented the treatment efficacy and~     cost effectiveness of early intervention. These results have major implications for effective~     early intervention and significant health care cost savings for this prevalent pain and~     disability problem. For the present proposed project, we plan to implement this treatment~     program in order to evaluate its effectiveness in more community-based dental practices. This~     is in response to NIH's request for the implementation of evidence-based treatment~     approaches, developed in controlled clinical settings, to the real world of diverse~     practices in the community. Acute TMJMD patients will be recruited from two community-based~     clinics. Based upon our risk screening algorithm, high-risk patients will be randomly~     assigned to one of two groups (n=225/group): an early biobehavioral intervention or an~     attention-control group. It is hypothesized that the attention control high-risk patients~     will display more chronic TMJMD problems, relative to the high-risk early intervention~     patients, at one- and two-year follow-ups. A number of biopsychosocial measures will be~     evaluated, including chewing performance, the RDC/TMD, self-reported pain and stress, etc.~     Such a multi-level, multi-systems approach has not been applied to better understand the~     biopsychosocial underpinnings of TMJMD. Results from this component of the project will~     greatly aid in stimulating future research leading to the better understanding of TMJMD, as~     well as better tailoring of prescribed treatment regimens.~   "
199387|NCT00952887|"~     The purpose of this study is to establish safe dose levels of ACE-031 in healthy~     postmenopausal women following multiple dose administration. This study will also evaluate if~     ACE-031 has an effect on muscle.~   "
210615|NCT00803907|"~     This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the~     periorbital region.~   "
199388|NCT00952874|"~     The molecular mechanisms involved in squamous cell carcinoma of the anus (SCCA) are poorly~     elucidated. HIV-positive and renal transplant patients are at high risk for developing SCCA,~     indicating that immune suppression plays a facilitating role. The investigators previously~     demonstrated that chromosomal instability (CIN) was more prevalent in SCCA of HIV-negative~     than HIV-positive patients. Hence, the investigators postulate that microsatellite~     instability (MSI), another molecular pathway, might be a feature of SCCA progression in the~     HIV-positive population.~      Study Aims:~        1. to determine the prevalence of MSI in paraffin-embedded tumor specimen of 15 patients~          from the Swiss HIV cohort who underwent surgical excision for SCCA; and~        2. eventually, to test our hypothesis by assessing the MSI status of SCCA in 15 recently~          operated HIV-negative patients.~      Study Design:~      The study is designed in two steps:~        1. Firstly, the investigators will retrieve tumor specimen from 15 HIV-positive patients,~          with a biopsy-confirmed diagnosis of SCCA, in three institutions. DNA from tumor and~          normal tissues will be extracted, and then amplified by PCR. Presence of MSI in tumors~          will be determined by assessing the microsatellite markers BAT25, BAT26, and CAT25.~        2. Secondly, the results of molecular analysis will be compared with a population of~          HIV-negative patients, with the same tumors, using the same detection technique for MSI.~   "
199389|NCT00952861|"~     It is not clear whether antibiotic therapy is needed in patients with mild to moderate~     exacerbation of chronic obstructive lung disease. The aim of the study is to compare the~     effect of 1 day of treatment with 6 days of treatment in patients who are admitted to~     hospital and being clinical stable (as judged by their physician) 24 hours after~     hospitalization~   "
199390|NCT00952848|"~     RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients~     who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.~      PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing~     peripheral neuropathy caused by chemotherapy.~   "
199391|NCT00952835|"~     In this study will be consecutive enrolled children with asthma (classified according to GINA~     guidelines) and rhinitis (classified by ARIA guidelines); the investigators will research~     clinical personal and parental history regarding allergic diseases, exposition to passive~     smoking and interpretate hematochemical parameters markers of atopy. Skin Prick Tests will be~     performed. In this study the investigators will evaluate lung function parameters (spirometry~     with bronchial reversibility test and exercise induced bronchoconstriction, oscillometry,~     respiratory plethysmography, etc.), airway inflammatory indices such as exhaled nitric oxide~     at different flows, exhaled and nasal temperature, nasal cytology.~      The aim of the study will be to evaluate possible correlation between these different~     parameters and clinical status of the patients.~   "
199392|NCT00952822|"~     The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic~     factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water~     for injection (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.~   "
199393|NCT00952796|"~     On the basis of monotherapy for intra-abdominal infection, the investigators are conducting~     this study to identify the difference of drug efficacy between ampicillin/sulbactam and~     moxifloxacin.~   "
199394|NCT00952783|"~     This study is designed to follow up patients, who have achieved complete clearance of AK~     lesions (lesion count of 0) at Day 57 in the PEP005-020 study, over a 12 month period to~     assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected~     treatment area.~   "
199395|NCT00952770|"~     The first event of the atherosclerotic plaque formation is the accumulation of the low~     density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall.~     After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and~     recruitment of monocytes to the intima and media are the next steps. The thickening of~     intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily~     measured by high-resolution ultrasonography in various arteries including carotid, brachial~     and radial arteries. The increased carotid IMT can be used as a non-invasive independent~     parameter indicating increased cardiovascular mortality. Some investigators reported~     increased radial IMT is associated with increased early failure of the radiocephalic~     arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in~     patients underwent radial artery intervention because of denudation injury of the radial~     artery. Recently, the use of statin can halt the progression of the carotid IMT progression.~     However, it is unknown that the use of statin can prevent the progression of radial IMT after~     the transradial coronary intervention. The investigators want to evaluate the effect of~     statins on the progression of the radial IMT after the transradial intervention.~   "
199396|NCT00952757|"~     Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some~     atypicals. Clinical consequences of hyperprolactinaemia are broad including amenorrhea,~     galactorrhea, tender breasts, gynecomastia and sexual dysfunction. Less known but also~     present is the increased cardiovascular risk, specially in women, disorders of osteoporotic~     type and a potential increased risk of breast and prostate cancer.~      Despite this growing evidence, there are no consistent published data in order to adopt~     evidence-based decisions that may be beneficial for the patient.~      This naturalistic observational 6 months follow-up study on patients with APS-induced~     hyperprolactinemia aims to obtain more information about the switching approach in cases of~     hyperprolactinemia secondary to APS and to better establish the role of switching to~     quetiapine (APS not related with the increase prolactin levels) in this problem.~   "
199397|NCT00952744|"~     While troponin is not detectable until several hours after an Acute Myocardial Infarction~     (AMI), copeptin is expected to be elevated very early after an AMI. A combination of both~     markers for the diagnosis of AMI early after the event is therefore expected to be~     advantageous.~   "
199398|NCT00952731|"~     This randomized phase II trial is studying 4-hydroxytamoxifen to see how well it works~     compared with tamoxifen citrate in treating women with newly diagnosed ductal breast~     carcinoma in situ. Estrogen can cause the growth of breast cancer cells. Hormone therapy~     using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells.~     It is not yet known whether topical tamoxifen causes less damage to normal tissue than~     systemic tamoxifen in treating patients with ductal carcinoma in situ.~   "
200539|NCT00937820|"~     The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in~     patients with a history of venous thromboembolism.~   "
199401|NCT00952692|"~     This is a phase I/II study to determine the safety and gain insight into the immune response~     of the immunologic agent dHER2+AS15 ASCI when administered in combination with lapatinib.~     This study is for patients with metastatic breast cancer (invasive breast cancer with stage~     IV disease) that overexpresses HER2 and is resistant to trastuzumab (Herceptin).~      The dHER2 + AS15 candidate Antigen-Specific Cancer Immunotherapeutic (ASCI) contains a~     recombinant protein termed dHER2, which is a truncated version of the HER2 protein. HER2 is a~     protein that is commonly overexpressed in breast cancer. This protein is combined with the~     immunological adjuvant AS15 Adjuvant System from GSK (GlaxoSmithKline), which is a liposomal~     formulation containing three immunostimulatory components.~      Lapatinib is FDA approved for use in combination with capecitabine for the treatment of~     subjects with advanced or metastatic breast cancer whose tumors overexpress HER2.~   "
199402|NCT00952679|"~     Breast cancer patients who diagnosed by core needle biopsy or excisional biopsy underwent CT~     scan to locate the sentinel lymph node (SLN) before SLN biopsy (SLNB) at the same day of~     surgery. When CT examination performed, those patients were in supine position, with the arms~     stretched upward but bent at the elbow with the hands at the side of the cranium which~     similar to the surgical position. After local anesthesia, 2mL of iopamidol was injected~     subcutaneously to the peritumoral and peri-areolar areas followed by gentle massage for about~     1 minute. Contiguous 2-mm-thick CT images that included the breast and axilla were obtained~     prior to administration of the contrast agent. After 3D CT reconstruction, the SLN was~     identified as the most inferiorly visible nodule in the axilla connected to the lymphatic~     vessel on the CT imaging monitor. A professional intervention doctor punctured the defined~     lymph node guided by the CT monitor using the Breast Lesion Localization Needles (interv).~     The needle would stay in the patient's axilla until the surgery. All the lymph nodes~     including the CT defined one and which marked by methylene blue dye or 99mTc-sulfur colloid~     tracers were removed, which then would be tested by touch imprint cytology for the~     intraoperative diagnosis. Patients who had positive SLN would receive axillary dissection.~     The investigators evaluated the new method by comparing lymph nodes defined by CT and~     traditional ways.~   "
199403|NCT00952666|"~     Neurovascular bundle (NVB) contains capsular vessels to the prostate and cavernous nerves~     that provides the macroscopic landmark used during nerve-sparing radical prostatectomy. The~     preservation of NVB during radical prostatectomy improves postoperative recovery of potency~     and continence. However, the visualization of the NVB during radical prostatectomy can be~     challenging.~      Recently, an attempt has been made to use a transrectal ultrasound (TRUS) imaging to~     delineate the anatomy of the prostate gland and NVB during laparoscopic radical~     prostatectomy. However, it is difficult to obtain a steady image of TRUS with an operator.~     The investigators plan to perform a feasibility study to obtain TRUS imaging of the prostate~     and NVB during robot-assisted laparoscopic radical prostatectomy (RALRP). The investigators~     plan to use a robot-assisted TRUS probe holder to gently manipulate the probe to obtain~     steady TRUS images that may aid in visualization and dissection of the NVB during RALRP.~   "
199404|NCT00952653|"~     The main purpose of this study is to evaluate the effect of desvenlafaxine administered as~     DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount~     of drug in the body and the effect of the drug will also be evaluated.~   "
199405|NCT00952640|"~     Background:~      Vitamin A is of utmost importance for health and survival of children. A recent series in The~     Lancet on maternal and child health put vitamin A deficiency at the top of most important~     micronutrient deficiencies, responsible for more than 600.000 child deaths/year worldwide.~     Vitamin A status of mothers and infants is closely linked. Hence, a mother with vitamin A~     deficiency cannot give enough vitamin A to her fetus to build stores during the last months~     of pregnancy, and will also have insufficient amounts of vitamin A in her breast milk,~     resulting in a high risk for vitamin A deficiency in her newborn infant. The World Health~     Organization (WHO) has implemented several strategies to fight vitamin A deficiency in~     mothers and children. One of these is to give women after delivery a high dose vitamin A~     supplement, to improve vitamin A status of mother and, via breast milk, her infant.~     Surprisingly however, several recent studies investigating the effect of a high dose vitamin~     A supplement for mothers directly after birth found no effect on vitamin A status in infants~     6 months of age. In contrast, earlier studies in Bangladesh and Indonesia, in which women~     received a high dose vitamin A supplement somewhere in the first 6 weeks after delivery,~     reported a large impact on vitamin A status in the infants at 6 mo of age. The WHO~     recommendation on post-partum vitamin A supplementation was based on these earlier studies~     from Bangladesh and Indonesia. The more recent studies suggest however that this intervention~     is not effective, and that millions of women currently receive a high dose vitamin A~     supplement without clear benefits for vitamin A status in either the women or their children.~      The human body reacts to infection or injury with an inflammatory response, which kicks off~     with the acute phase response. The acute phase response helps the body to fight the~     infection. It is characterized by many altered physiological processes, including changed~     availability of vitamins and minerals. Recently, we found that delivery in itself causes a~     major acute phase response. We have formed the hypothesis that the acute phase response~     initiated by delivery prevents the high dose vitamin A supplement given to the mother~     directly after delivery from being absorbed and from being available for breast milk. If this~     is true, the current WHO recommendation to give the vitamin A within the first 6 weeks~     post-partum should be changed to giving the vitamin A 4 - 6 weeks post-partum instead, to~     allow the acute phase response induced by delivery to fade.~      Objective(s) and Hypothesis(es):~      The main objective is to improve the effectiveness of the current WHO policy of vitamin A~     supplementation after delivery to improve vitamin A status and health of mothers and their~     infants.~      Methodology:~      In a randomized, placebo-controlled, double-blind trial, 400 women will receive a high dose~     of vitamin A (200.000 IU) within 6 weeks of delivery, as recommended by WHO. Half of the~     women will receive the vitamin A directly after delivery (within 3 days, current practice),~     whereas the other women will receive the vitamin A 6 weeks after delivery. To guarantee~     blinding, women will receive a placebo capsule if they are not receiving a vitamin A capsule.~      Main outcomes will be maternal and infant vitamin A status 6 months post-partum and the~     time-course of the acute phase response, to establish the optimal time after delivery for the~     initiation of the vitamin A supplementation.~      Secondary outcomes will be the morbidity of the infants during the first 6 months of life and~     growth performance of the infants at 6 mo of age.~      Potential Impact:~      The results of this study will enable WHO to improve the effectiveness of the current WHO~     recommendations concerning post-partum vitamin A supplementation. If our hypothesis is true,~     postponing the timing of the post-partum vitamin A supplement from directly after delivery to~     6 week post-partum, will significantly increased the availability of the supplement for the~     mother. This will increase the vitamin A status of both mother and infant. Moreover, there~     are several significant implications for global health policies, with important consequences~     for infant survival worldwide by reducing morbidity and mortality from infectious diseases~     during the first 6 months of life. Results of the study will also have important consequences~     for other micronutrient health programs, such as vitamin A supplementation for children above~     6 months of age and iron supplementation in areas with endemic malaria, as these are also~     subject to the effects of the acute phase response~   "
199406|NCT00952627|"~     The purpose of this study is to determine whether Pycnogenol, a natural pine bark extract, is~     effective in modifying the age-dependent process of cardiac fibrosis and diastolic function~     in aged hypertensive subjects.~   "
199407|NCT00952614|"~     The purpose of this study is to determine whether a fluocinolone sustained drug delivery~     implant is effective in the treatment of central retinal vein occlusion that has caused~     persistent macular edema and decreased visual acuity.~   "
199408|NCT00952601|"~     Pharmacotherapy has long been considered the primary approach for tic suppression in Tourette~     syndrome (TS). Unfortunately, medications are often ineffective and frequently have~     significant side-effects. This is a pilot therapeutic study using a dietary approach, the~     modified Atkins diet (MAD). The goal of this study is to establish the safety, tolerability,~     and efficacy of dietary therapy in patients with TS (proof of concept) and to determine~     whether this intervention is worthy of evaluation in large-scale clinical trials. The~     modified Atkins diet mimics the well established ketogenic diet, but in a less-restrictive~     dietary manner. Dietary approaches using the MAD/ketogenic diet are currently under~     investigation for neurological conditions other than epilepsy, including Alzheimer disease,~     headaches, autism, narcolepsy, brain tumors, traumatic brain injury, Parkinson's disease, and~     depression.~   "
199409|NCT00952588|"~     The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone~     and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in~     AML patients.~   "
199410|NCT00952575|"~     This phase II study is designed to demonstrate the ability of LFB-R593 to effectively~     eliminate exogenously-administered RhD-positive red blood cells from the circulation of an~     RhD-negative individual, thereby preventing RhD-alloimmunisation.~   "
199411|NCT00952562|"~     A randomized placebo controlled trial evaluating the effect of the recently recommended high~     doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave~     analysis in healthy individuals.~   "
199412|NCT00952549|"~     The primary objective of this study is to determine the efficacy of a facial yoga exercise~     program on appearance and to measure patient satisfaction with facial yoga practice.~   "
199429|NCT00952328|"~     The aim of this study is to conduct a pilot randomized controlled trial of the effect of~     early limited formula supplementation on breastfeeding-related outcomes for infants with high~     early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at~     24-48 hours of age and will randomly assign them to early limited formula supplementation~     following nursing (intervention group) or to no formula feeding (control group). Both groups~     will receive intensive lactation support. Outcome variables will include breastfeeding status~     on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and~     exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that~     early limited formula supplementation might help infants with early weight loss avoid~     eventual weight loss ≥ 10% and associated breastfeeding problems.~   "
211431|NCT00793026|"~     The purpose of this study is to prove the safety of the gynaecological formulation in normal~     conditions of use.~   "
199413|NCT00952536|"~     There are 3 hypotheses to be tested:~        1. That daily supplementation with Juice Plus+ will significantly improve treatment~          outcomes over placebo supplementation, at 3-months post-therapy, when used as an adjunct~          to conventional non-surgical periodontal therapy.~        2. Triple therapy with Juice Plus+ (fruit, vegetable & berry) will produce additional~          treatment benefit over dual therapy (fruit & vegetable) and over placebo.~        3. Improved treatment outcomes with Juice Plus+ will be maintained at 9-months~          post-therapy.~      Brief Summary:~      Periodontal diseases are highly prevalent chronic inflammatory diseases and a major cause of~     tooth loss. Data supports an association between periodontitis prevalence and reduced serum~     levels of antioxidants. Anecdotal reports from periodontal specialists indicate significant~     improvements in clinical outcomes from periodontal therapy where adjunctive Juice Plus+ is~     used, in agreement with research data from other systemic diseases where hyper-inflammation~     is implicated in disease pathogenesis. There is however, a lack of scientific evidence from~     clinical trials of periodontitis. Given the demonstrable antioxidant deficiency in~     periodontitis patients (both locally and peripherally), the excess oxidative stress in~     periodontitis patients, and the anecdotal evidence of clinical benefit from the adjunctive~     use of Juice Plus+, this study proposes to investigate the impact of daily supplementation~     with Juice Plus+ as an adjunct to traditional non-surgical periodontal therapy, in improving~     therapeutic outcomes.~   "
199414|NCT00952523|"~     A study to compare the skin irritation potential of two marketed gels for acne treatment,~     each applied to half of the face of healthy volunteers.~   "
199415|NCT00952510|"~     Rationale: Neck complaints are often caused by motor vehicle accidents and particular after~     rear-end collision. Patients complain about neck pain after a whiplash trauma, which lead to~     mobility restrictions of the cervical spine. It is estimated that 20% develop a chronic pain~     disorder after 1 year, called a chronic whiplash syndrome.~      Objective: the primary objective is to investigate the natural course of active-and passive~     range of motion and principally the difference score between active-and passive cervical~     range of motion after a whiplash trauma. The secondary objectives are: investigate the~     predictive value of active-and passive range of motion and chronicity. Further, the~     correlation between the degree of restriction of the active and passive backward flexion and~     chronicity will be investigated. Finally, the correlation between the possible predictive~     factors such as pain, ideas and feeling about pain, memory and attention, events of the last~     year and complaints after the motor vehicle accident and chronicity are examined.~      Study design and study population: a prospective cohort of 100 whiplash patients which~     underwent a measurement of the cervical movements and gave permission to recontact them for~     further research.~   "
199416|NCT00952497|"~     The objectives of this study are to evaluate the anti-tumor activity, safety, and~     tolerability of telatinib when used in combination with chemotherapy (capecitabine and~     cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary~     objective is to assess progression free survival (PFS) in subjects receiving telatinib in~     combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to~     assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and~     biomarkers.~   "
199417|NCT00952484|"~     This clinical trial studied the safety and efficacy of asfotase alfa in children with HPP~     compared to a historical control group.~   "
199418|NCT00952471|"~     Selective redesign of order sets using different ways to frame the order and physician~     decision-making in a computerized provider order entry system could increase adherence to~     evidence-based care and reduce population-specific variance.~   "
199419|NCT00952458|"~     This randomized study investigates the benefits of an additional Bispectral Index monitoring~     of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral~     index (BIS) monitor is a neurophysiological monitoring device which continually analyses a~     patient's electroencephalograms during general anaesthesia to assess the level of~     consciousness during anaesthesia.~   "
199420|NCT00952445|"~     The purpose of the study is to determine if repeated daily doses of T0903131 (INT131)~     Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes~     Mellitus.~   "
199421|NCT00952432|"~     The goal of the study is to utilize BCTQ(Boston Carpal Tunnel Questionnaire), VAS (Visual~     Analog Scale), NCS (Nerve Conduction Study), and MET(Multiple Excitability Test) to evaluate~     and compare the efficacy of Acupuncture Therapy and Carbamazepine in Patients with Carpal~     Tunnel Syndrome.~   "
199422|NCT00952419|"~     The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic~     vaccine in toddlers and children.~      Primary Objectives:~        -  To describe the immunogenicity of the candidate vaccines after each injection.~        -  To describe the safety of the candidate vaccines after each injection.~   "
199423|NCT00952406|"~     Study Aims:~        1. To validate a new measure of sexual function and activity in women with PFDs;~        2. To establish the responsiveness to change of the new measure.~      The investigators hypothesis is that the investigators can create a new questionnaire that~     accurately measures sexual health in women with pelvic floor disorders that improves on the~     already published questionnaires.~   "
199424|NCT00952393|"~     The study determines if a new preparation of a drug designed to treat schizophrenia is more~     slowly released into the body.~   "
199425|NCT00952380|"~     Three month treatment of acute VTE with Fragmin in pediatric cancer patients~   "
199426|NCT00952367|"~     This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus~     influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged~     12-18 months in order to estimate the prevalence of pathogens that commonly cause infection~     in Chinese young children. The antibiotic resistance of all isolates and the serotypes~     distribution of S.p. isolates will also be tested. Potential risk factors for nasopharyngeal~     carriage will be collected.~   "
199427|NCT00952354|"~     The objective of this research is to verify the language of children with Down syndrome~     concerning lexical, syntactic and semantic aspects using MLU. The hypothesis is that children~     with Down syndrome will present low performance, regarding not only the quantitative measures~     as MLU-m, MLU-w, GM-1 and GM-2, but also regarding the qualitative aspects of their~     production, when compared to children with typical development.~   "
199428|NCT00952341|"~     This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment~     of chemotherapy-induced nausea and vomiting in Chinese patients.~   "
199432|NCT00952289|"~     This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib~     (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis~     (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or~     Post-Essential Thrombocythemia Myelofibrosis (PET-MF).~   "
199433|NCT00952276|"~     The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic~     vaccine in adults and the elderly.~      Primary Objectives:~        -  To describe the immunogenicity of the candidate vaccines after a single injection.~        -  To describe the safety of the candidate vaccines after a single injection.~   "
199434|NCT00952263|"~     This is a phase I, open-label, dose escalation study to evaluate the safety of MBL-HCV1 in~     healthy adult volunteers. Eligible volunteers will be admitted to a phase 1 unit for study~     infusion. A single dose of human monoclonal antibody will be administered. The study duration~     is 56 days. During this time, safety will be assessed via physical examinations, laboratory~     testing, concomitant medication usage and review of treatment emergent adverse events should~     they occur. Pharmacokinetics will be derived from analysis of blood samples obtained during~     the 56 day study.~   "
199435|NCT00952250|"~     This project is designed to examine the impact of tailored feedback on site performance.~      The investigators' objective is to evaluate whether a 'personalized and targeted' feedback,~     education and performance improvement intervention has a greater impact on adherence to~     recommended guidelines than standard feedback.~      The investigators hypothesize that a site-specific report with centrally identified targets~     for improvement paired with target specific interventions will enable sites to quickly~     identify and prioritize salient problem areas, have ready access to an analysis of factors~     that underlie problems, and formulate an effective action plan. The investigators also~     hypothesize that those hospitals randomized to receive intervention will be more likely to~     improve their overall performance, as well as their target specific performance, during the~     period of observation in direct response to activated QI processes.~      Outcomes:~      The primary outcome is improvement in the overall composite of all metrics eligible for~     intervention regardless of their selection as targets.~      The secondary outcome is improvement in the composite of targeted metrics.~      Outcomes will be assessed in all participating sites, and in among relevant performance~     subgroups (low performers, academic centers, full service, and among medication versus~     process metrics).~   "
199436|NCT00952237|"~     We postulate that the combination of IL-2 and GM-CSF immunotherapy will efficiently mobilize~     autologous peripheral blood stem cells and activated immune effector cells in patients with a~     hematologic malignancy. These activated effector cells will improve the immune function of~     the graft. These hypotheses will be tested using this proposed clinical trial to mobilize~     autologous peripheral blood stem cells pre-transplantation.~   "
199437|NCT00952224|"~     In acute myocardial infarction cardiovascular magnetic resonance imaging can retrospectively~     detect the myocardium at risk and the irreversible injury. This allows for quantifying the~     extent of salvaged myocardium after reperfusion as a potential strong end point for clinical~     trials and outcome. The aim of the present study is to determine the prognostic significance~     and determinants of myocardial salvage assessed by CMR in reperfused ST-elevation myocardial~     infarction (STEMI).~   "
199438|NCT00952211|"~     There are two purposes of this study. The first purpose is to define the frequency of~     obstructive sleep apnea in stroke survivors as well as its association with fatigue and~     quality of life. The second purpose is to determine if continuous positive airways pressure~     (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.~   "
199439|NCT00952198|"~     This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of~     investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin~     therapy) in patients with Type 2 diabetes. Approximately 128 patients from the US will be~     enrolled in this study.~   "
199440|NCT00952185|"~     RATIONALE: The influenza vaccine may help prevent flu in patients who have undergone stem~     cell transplant.~      PURPOSE: This clinical trial is studying how well the influenza vaccine works in preventing~     flu in patients who have undergone stem cell transplant and in healthy volunteers.~   "
199441|NCT00952172|"~     This 3-year prospective, randomized, control, longitudinal study is aimed to (1) examine the~     effect of stair stepping exercise training on cardiopulmonary fitness and sleep situation in~     patients with Obstructive Sleep Apnea Syndrome (OSAS), and (2) follow the longitudinal change~     after stair stepping exercise training in patients with OSAS. Patients meet the following~     criteria will be invited to participate in this study: being diagnosed with AHI~     (Apnea-hypopnea index)＞15/hr and ODI (oxygen desaturation index)＞10/hr by Polysomnography,~     aged 19 or older. Based on the power analysis, 70 patients with OSAS treated in the~     outpatient department of Chang Gung Medical Center will be recruited over a period of 26~     months. Each patient will participate in this study for seventeen weeks. Patients will be~     randomly assigned to receive stair stepping exercise in addition to nursing education and~     standard care, or nursing education and standard care alone. Stair stepping exercise will be~     performed at home daily for eight weeks. Outcomes will be determined by changes in the scores~     of cardiopulmonary fitness index, VO2max, six-minute walking distance, daytime sleepiness~     measured by Epworth Sleepiness Scale, sleep time measured by Actigraphy, and AHI measured by~     Polysomnography; those taken four times: before treatment (baseline), five weeks, nine weeks,~     and seventeen weeks of the study. Data will be analyzed using descriptive statistics and~     Generalized Estimating Equation (GEE).~   "
199454|NCT00952003|"~     The primary objective of this study is to determine the efficacy of an Oxaliplatin /~     Irinotecan / Bevacizumab therapy followed by Docetaxel / Bevacizumab therapy followed by~     Bevacizumab until progression in the treatment of locally advanced metastatic gastric cancer,~     in terms of response rates (complete or partial response, determined by radiologic evaluation~     according to Response Evaluation Criteria in Solid Tumors (RECIST)).~      Secondary objectives Secondary Objective: To determine the safety profile of a an~     Oxaliplatin/Irinotecan/Bevacizumab therapy followed by Docetaxel/Bevacizumab therapy followed~     by Bevacizumab until progression in terms of qualitative and quantitative toxicities from~     first study treatment dose until completion of study treatment due to progression or for any~     other reason.~      Secondary Objective: To evaluate the study population with respect to the following: overall~     survival (from treatment start until death from any cause) and progression free survival~     (from treatment start until progression or death from any cause).~   "
199442|NCT00952159|"~     Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based~     on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on~     genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research,~     in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population.~     Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs,~     particularly of two opioids involved in pain management: codeine and tramadol, their~     metabolites representing the most effective part of the drug effect. So prescribing codeine~     or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain~     management.~      O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, is important to consider because~     its analgesic effect is 2 to 4 times more potent than tramadol.~      The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol~     by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in~     comparison with genotype, and to find a threshold to determine poor metabolizers. As already~     described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in~     poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a Caucasian population. Sampling will be~     executed at two times (H24 and H48 after surgery) and only with blood (three EDTA tubes)~     during the post-operative monitoring of the patients. This study is likely to include 320~     post-operative patients treated with intravenous tramadol during one year in three university~     hospitals centers (CHU of Caen, Creteil and Rouen).~      The first aim of this study is the validation of monitoring seric concentrations of~     O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor~     metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a~     poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding~     tramadol and codeine. The final objective of this research is to be able to determine the~     CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take~     of blood and a rapid response, this method should be liked to improve pain management.~     Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs~     depend on this way of metabolism.~   "
199443|NCT00952146|"~     This study is a feasibility study. Patients with acute abdominal pain who are planning to~     undergo a diagnostic laparoscopy are asked to participate in the study. The aim of the study~     is to evaluate if transgastric peritoneoscopy is feasible.~   "
199444|NCT00952133|"~     The purpose of this study is to determine if subjects who receive Palonosetron plus~     Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive~     Palonosetron alone.~   "
199445|NCT00952120|"~     The purpose of this study is to compare how well two methods (VAC and G-SUC) of securing skin~     grafts using negative pressure wound therapy work. Negative pressure wound therapy is a~     commonly used method of applying suction on wounds to remove fluid from wound and to promote~     healing. The VAC system is widely used and consists of a foam dressing and a portable~     computerized suction pump. The G-SUC method uses commonly available dressing supplies~     attached to vacuum (suction) pump located on the wall above a hospital bed. The investigators~     have frequently used both methods over the past 10 years and have not observed any specific~     negative side effects of either.~   "
199446|NCT00952107|"~     The main purpose of this study is to test the ergonomics of an investigational imaging system~     that can take pictures of blood vessels under the skin. In plastic and reconstructive~     surgery, blood flow to tissue determines whether the tissue can be transplanted from one~     location to another. This new imaging device uses invisible near-infrared fluorescent light~     to see blood vessels that otherwise could not be seen by eye. This study will test the~     system's basic operation and ergonomics in the operating room.~   "
199447|NCT00952094|"~     Randomized, open, single ascending dose, parallel study to evaluate the pharmacokinetics,~     pharmacodynamics and safety of KRN1493 after single oral administration in healthy Korean~     male volunteers.~   "
199448|NCT00952081|"~     This protocol describes a study to gain experience in the use of Clevidipine for~     perioperative blood pressure control in patients undergoing craniotomy for brain tumor or~     epilepsy focus resection. The purpose of this study is to establish the efficacy of~     Clevidipine for intraoperative blood pressure control in patients undergoing intracranial~     procedures, and gather information on the dosage and adverse effects of Clevidipine in~     neurosurgical patients. This initial pilot experience serves to familiarize the investigators~     with the use of this drug prior to initiating a planned randomized trial versus institutional~     standard-of-care therapy. The investigators will obtain greater familiarity with the dosing~     of clevidipine in this patient population and collect information on the incidence of adverse~     effects.~   "
199449|NCT00952068|"~     The primary objective of this study is to determine the time of onset of analgesic effect of~     Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include~     determining the relationship between analgesic effect and plasma levels for Tramadol~     Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol~     Contramid® OAD.~   "
199450|NCT00952055|"~     This is a prospective observational study focused on monitoring the effects of various~     treatment options for acute coronary syndrome (ACS) patients by measuring serum neopterin~     levels. Serum neopterin is a marker for measuring macrophage activation. Prior studies have~     illustrated that there are elevated serum neopterin levels in ACS. Patients enrolled are~     those with ACS. Blood samples are drawn at presentation, and at 72 hours after admission, or~     at office visits and at 72 hours later. Neopterin levels are measured via a commercially~     available assay..~   "
199451|NCT00952042|"~     The use of eccentric resistance training as management of Achilles tendinopathy is~     widespread. The investigators have recently demonstrated that heavy slow resistance training~     was superior in the management of patellar tendinopathy.~      Hypothesis: heavy slow resistance training is more effective than eccentric resistance~     training in the clinical management of Achilles tendinopathy.~   "
199452|NCT00952029|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium,~     and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Bevacizumab may stop the growth of colorectal~     cancer by blocking blood flow to the tumor. It is not yet known whether giving more than one~     drug (combination chemotherapy) is more effective when given with or without bevacizumab in~     treating patients with metastatic colorectal cancer.~      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or~     without bevacizumab to see how well it works in treating patients with metastatic colorectal~     cancer.~   "
199453|NCT00952016|"~     To assess the efficacy of methotrexate in a genetically selected population of patients with~     advanced colorectal cancer, who have loss of a particular gene, MSH2. The efficacy of~     methotrexate will be evaluated by the proportion of cases that have a significant response to~     treatment (objective response rate).~   "
199584|NCT00950313|"~     The purpose of this study is to establish the most effective method of increasing attendance~     to screening of type 2 Diabetes within a primary care setting within the backdrop of the NHS~     Health Check programme.~   "
199681|NCT00949052|"~     RATIONALE: Identifying genes that increase a person's susceptibility to second cancers may~     help the study of cancer treatment.~      PURPOSE: This study is looking at genetic susceptibility and risk of second cancers in~     patients who have undergone stem cell transplant for cancer.~   "
199455|NCT00951990|"~     Despite the widespread use of hip and knee replacement surgery, there is a considerable lack~     of consensus regarding postoperative treatment and rehabilitation, mostly because of the lack~     of well-designed studies testing the efficacy and effectiveness of such practices.~      In particular there are no recommendations regarding the use of ergometer cycling after hip~     or knee replacement surgery.~      Therefore the investigators initiated a multicenter controlled clinical trial evaluating the~     effect of ergometer cycling versus no ergometer cycling after hip or knee replacement~     surgery.~   "
199456|NCT00951977|"~     Kidney transplantation from living donors has been shown to carry many benefits over deceased~     donor transplantation. Because of benefits such as shorter waiting times and improved outcome~     for transplant recipients, living kidney donation accounts for an increasing number of kidney~     transplants nationwide. Most published studies about living kidney donation demonstrate that~     the procedure is safe, but they also emphasize concerns that long-term data on live donor~     outcomes are insufficient. The purpose of this study is to assess the long term outcomes and~     risks that may arise from living kidney donation.~   "
199457|NCT00951964|"~     Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of~     cutaneous bullous lesion arising spontaneously or after mechanical trauma.~      These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no~     treatment available. Cares are consisting to dress lesions and to protect the skin.~      The investigators have recently observed on patients having residual expression of collagen~     VII that phenotype severity is modulated by activation degree of dermic metalloproteinase.~     The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be~     regulated this activity.~      The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease~     the number of cutaneous bullosa after four month of treatment.~      The primary outcome measure is the rate of patient presenting a decrease of 20% or more of~     the number of cutaneous bullosa.~      Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the~     average duration of cicatrisation and treatment tolerance.~      This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.~      When patients are included, they will be randomized and receive the treatment (or placebo)~     for 4 months.~   "
199458|NCT00951951|"~     The primary objectives of the study is to compare gait kinematics and the return to~     normalization of gait in patients that have undergone a Total Hip Arthroplasty (THA) via the~     direct anterior approach versus the posterior approach. Gait kinematics will be measured~     using the IDEEA LifeGait device from Minisun (Fresno, CA).~   "
199459|NCT00951938|"~     The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody~     spacer and supplemental anterior fixation of the surgeon's choice and to follow the patients~     to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that~     Trinity Evolution combined with an interbody spacer and supplemental anterior fixation will~     result in fusion rates and clinical outcomes similar to those with other routinely used~     autograft and allograft materials including: fusion, improvement in pain and function,~     maintenance of upper extremity neurological function, and absence of serious adverse events~     related to the use of the Trinity Evolution product.~   "
199460|NCT00951925|"~     Potential donors who are undergoing bone marrow biopsy or bone marrow donation as part of~     clinical care will be asked by the principal investigator (PI) if they might be interested in~     donating marrow for this research project. If they are interested, the PI will meet with the~     prospective donor to review the information contained in the informed consent document and to~     answer any questions the potential subject may have. Bone marrow aspirates of approximately~     5cc will be obtained from the posterior iliac crest of subjects using standard techniques.~   "
199461|NCT00951912|"~     Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular~     disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of~     purified isoflavone components (genistein and daidzein) on glucose metabolism. This~     double-blinded, randomized, placebo-controlled trial will examine the effects of purified~     genistein and daidzein on glucose metabolism in prediabetic or diabetic women. One hundred~     and eighty eligible women age 30-70 years(without any treatment of diabetic drugs) will be~     recruited and randomly allocated into the following three arms: Placebo (10g isolated soy~     protein, ISP); Genistein (10g ISP + 50mg genistein); Daidzein (10g ISP + 50mg daidzein) per~     day for 6 mo. Fasting glucose, lipids, insulin, inflammation marks and post-load for glucose~     and insulin will be determined at 0, 3th, and 6th month. Changes in these indices will be~     compared among the three groups.~   "
199462|NCT00951899|"~     The goal of this study was to determine the metabolic mechanism for a certain type~     medication's ability to lower blood sugar after a meal in Type 2 Diabetics, in order to~     develop a better understanding of it's potential role in the treatment of obesity.~   "
199463|NCT00951886|"~     Rationale: Forced spirometry maneuvers are not routinely performed in patients with Ataxia~     Telangiectasia (A-T), even though they suffer from respiratory illnesses.~      Objectives: To study the feasibility and validity of forced spirometry in A-T patients.~      Methods: Patients will perform spirometry during clinical visits. Parameters studied will be~     technical quality, relation to predicted values, age, pulmonary illness, body mass index,~     mutational status and mutation.~   "
199464|NCT00951873|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety, local tolerability and pharmacokinetic profile (the determination of the~     concentration of the administered medication in blood over time) of long acting activated~     recombinant human factor VII when injected subcutaneously (under the skin).~   "
199474|NCT00951743|"~     This is a 24 week placebo controlled, double-blind, 2-arm study of ADAPTAVIR, Monomeric~     Dala1-peptide T-amide (mDAPTA) compared to placebo, in HIV infected individuals with~     suppressed plasma viral loads < 200 copies/ml by highly active antiretroviral therapy (HAART)~     treatment for at least 3 months prior to entry with at least 6 continuous months of HAART~     treatment preceding entry. 20 treatment and 20 placebo individuals will be enrolled in each~     arm. The study duration is 24 weeks on placebo or mDAPTA administered intranasally at 0.01 mg~     two times a day.~      The main (intent to treat) analysis is planned for the 24 week endpoint. The virological~     outcomes of interest in the present study are infectious virus recoverable from cellular~     (PBMC) sources and cellular viral mRNA and DNA copy numbers. Immune outcomes (plasma~     cytokines) associated with HIV disease, HIV replication, or immune function will be studied.~   "
199465|NCT00951860|"~     The heart rate variability assessment of the sympathetic-parasympathetic balance is a strong~     analytical tool in the autonomic nervous system (ANS) physiology, at each end of life.~      In neonatology, it represents an important marker for understanding the breath and cardiac~     dysfunction, incriminated in the pathophysiology of unexplained death syndrome and~     apnea-bradycardia of prematurity.~      If recent clinical studies conducted by our team highlight a close link between the~     maturation degree of the ANS and gestational or postnatal age, with a substantial autonomic~     dysfunction in preterm infants, no study to date has focused profile autonomic maturation in~     the first two years of life, as that period for the infant is a vulnerability window~     especially cardiopulmonary and neurological.~      Psychomotor prognosis of newborns is more serious if prematurity is important and if~     periventricular leukomalacia or cortical anatomical brain lesions are obvious. However, the~     conventional imaging (Trans fontanel ultrasound, CT, MRI) is not sufficient in the neonatal~     period to thoroughly evaluate the neurological risk situations. During the neonatal period,~     the assessment of autonomic control, in practice easily quantifiable from time and~     frequency-domain analysis of cardiac RR variability, could be a strong marker, at a given~     time, from a neurological disorder undetectable by imaging, including sympathetic and~     parasympathetic nerve conduction dysfunction in some brainstem nuclei and cortical areas.~      The postnatal profile of the autonomic balance, as a marker of well ANS regulation could~     become an additional support to correlate transient or permanent autonomic deficit with a~     psychomotor development disorder at 2 years of age or later. This tool could be a help to~     target the children with a neurological risk and to schedule early therapeutic interventions~     and psychological or educational support.~   "
199466|NCT00951847|"~     The purpose of this study is to compare the single-dose oral bioavailability of oxcarbazepine~     300 mg/5mL oral suspension of OHM Laboratories, USA (a subsidiary of Ranbaxy Pharmaceuticals~     Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of~     Novartis Pharmaceutical Corporation, USA in healthy, adult, male, human subjects under fed~     conditions.~   "
199467|NCT00951834|"~     EGCG has shown a neuroprotective effect in cell-experimental and animal studies. The~     neuroprotective mechanism of EGCG probably bases - besides the known antioxidant effect -~     amongst others on the modulation of several signal transduction pathways, the influence on~     the expression of genes which regulate cell survival resp. programmed cell death, as well as~     the modulation of the mitochondrial function. In different Alzheimer models EGCG seems to~     cause an induction of alpha-secretase and the endothelin-converting-enzyme, as well as to~     prevent the aggregation of beta-amyloid to toxic oligomers through the direct binding to the~     unfolded peptide.~      The investigators therefore expect EGCG to have a positive influence on the course of the~     Alzheimer´s Disease.~   "
199468|NCT00951821|"~     This study will develop an integrated treatment for adolescents who are depressed and~     suicidal and their parents who are depressed and have a history of suicidality.~   "
199469|NCT00951808|"~     Acute chest syndrome (ACS) is similar to severe pneumonia and is a common cause of~     hospitalizations for people with sickle cell disease (SCD). Blood transfusions are one~     treatment option for ACS. High levels of an enzyme called secretory phospholipase A2 (sPLA2)~     may be present in people before they develop ACS. This study will determine how well sPLA2~     levels can predict the onset of ACS and whether identifying high sPLA2 levels allows enough~     time to prevent ACS with blood transfusions. Results from this study will help to determine~     the feasibility of conducting a larger study that would further examine the use of sPLA2~     levels and blood transfusions to prevent ACS in people with SCD.~   "
199470|NCT00951795|"~     This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate~     CD4+ T-cells in whole blood over the measurement range expected for the intended population.~     The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and~     determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.~   "
199471|NCT00951782|"~     Deep transcranial magnetic stimulation (TMS) is currently being evaluated as a treatment~     option in major depression. It has been shown to be a safe procedure . Deep transcranial~     magnetic stimulation coils are designed to maximize the electrical field deep in the brain by~     the summation of separate fields projected into the skull from several points around its~     periphery. The device is planned to minimize the accumulation of electrical charge on the~     surface of the brain. Such accumulation can give rise to an electrostatic field that might~     reduce the magnitude of the induced electric field both at the surface and inside, thus~     reducing the depth penetration of the induced electric field . Deep transcranial magnetic~     stimulation could be more effective than repetitive transcranial magnetic stimulation due to~     its deeper penetration into brain tissues . The deeper penetration should produce greater~     action on nerve fibers connecting the prefrontal cortex to the limbic system.~      The ability of high-frequency repetitive transcranial magnetic stimulation (rTMS) to alter~     dopaminergic neurotransmission in subcortical structures could explain recent reports, which~     suggest that it has the potential to reduce smoking and nicotine craving. Ecihhammer et al~     demonstrated a reduction in the number of cigarettes smoked and in the desire to smoke after~     a single rTMS treatment (Eichhammer et al., 2003). In addition, Johan et al in a cross-over,~     double-blind, placebo-controlled study demonstrated a reduction in cigarette consumption and~     desire to smoke after a single repetitive transcranial magnetic stimulation treatment (Johann~     et al., 2003). Recently, the investigators have finished a complete study on nicotine~     addiction using repetitive transcranial magnetic stimulation for 10 consecutive days. They~     have found that 10 days of rTMS reduced significantly better from placebo the number of~     cigarettes smoked, nicotine dependence and craving (Amiaz et al 2007, in preparation).~     Interestingly, some of the effects were stronger in the sub-group of patients that were~     presented with smoking-related pictures immediately prior to stimulation onset. Although,~     these results are interesting and exciting, they have two important caveats. First, only~     about 50%-60% of the smokers responded to the repetitive transcranial magnetic stimulation~     treatment. Second, among those responded to the treatment, only 10% had quit totally from~     smoking. Therefore, the potential therapeutic benefit of this treatment is limited. The~     investigators' hypothesis is that deep transcranial magnetic stimulation may be more~     efficient in smoking cessation due to it's deeper penetration and therefore it's capability~     to stimulate deeper fibers of the dopamine-reward-activating system.~   "
199472|NCT00951769|"~     This is a non-human study, conducted in a simulation environment, with simulator manikins,~     and volunteers from anaesthesia. Trainees in their first 2 years of anaesthetics training~     will be randomised to a control group, a group following the Difficult Airway Society UK's~     Guidelines and the Australian Difficult Airway management algorithm. A simulated difficult~     airway will be created during the induction of anaesthesia. The investigators will examine~     adherence to guidelines, which would have been provided to participants before the~     experiment, as well as compare their performance with the guidelines.~   "
199473|NCT00951756|"~     The purpose of this study is to determine the effect of dietary fat, in standard formulation,~     on the composition of the human microbiome in a prospective study of normal volunteers.~     Participants will be randomly assigned to either a high fat or low fat diet for 10 days. The~     gut microbiome will be phylotyped in fecal samples as well as in bacteria adherent to the~     colonic mucosa prior to, and during the course of the dietary interventions.~   "
199489|NCT00951548|"~     This is a double-blind, randomized, placebo controlled study to assess the beneficial effects~     of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in~     patients affected by mild to moderate active ulcerative colitis.~   "
199596|NCT00950157|"~     The purpose of this study is to test whether cautions about the evidence, in this case an~     open questions statement, decreases enthusiasm for drugs that are approved on surrogate~     outcomes (compared to patient outcomes) alone.~   "
201858|NCT00920270|"~     Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram~     Negative Bacteria should be more effective than conventional therapy~   "
199475|NCT00951730|"~     People with Down syndrome are at increased risk of sleep apnea, not only from obstruction of~     the upper airway, but also of central origin. According to published data, sleep apnea may~     occur in at least 40% of children and adults with Down syndrome. Consequences of these sleep~     apnea are numerous : failure to thrive, cognitive decline, high blood pressure, heart~     disease, accident due to day sleepiness, fatigue. This condition is treatable in people with~     Down syndrome, as it is in ordinary people.~      Diagnosis of sleep apnea in people with Down syndrome is therefore a major concern. In~     addition, data regarding age of apparition of this complication are missing, making repeated~     screening necessary.~      Polysomnography is the method of choice for the diagnosis of sleep apnea. Unfortunately, it~     is time consuming and sleep departments are heavily busy.~   "
199476|NCT00951717|"~     This study will test an intervention that aims to prevent postpartum depression by providing~     new mothers with information on and resources for dealing with the disorder.~   "
199477|NCT00951704|"~     The prognosis of cardiac arrest patients is generally poor. Recent studies have showed that~     the high quality of CPR increases the survival after cardiac arrest. Therefore the~     investigators planned this prospective observational study to determine the epidemiology of~     sudden cardiac arrest in the prehospital setting of Tampere area, the quality of the CPR, and~     also the associations between depth and frequency of chest compressions and invasive arterial~     pressure, EtCO2,cerebral oxygenation and iatrogenic injuries associated to chest compressions~     1) in patients resuscitated out of hospital by emergency medical service's (EMS's) personals~     and 2) in-hospital by hospital resuscitation team members. In addition, the investigators~     will analyze the effects of the chosen method of resuscitation on critical vital signs (Etco2~     and invasive pressures): closed-chest CPR is compared to open-chest CPR, or mechanical CPR~     with a device (AutoPulse-CPR, Cardio Pump) compared to manual CPR guided with quality CPR~     device. The results will give the investigators important insights into the haemodynamics of~     CPR which may guide future strategies for the management of cardiac arrest. The research~     group is also interested in CPR related injuries and mattress effect. Quality of life after~     CA is evaluated among survivals and the cause of death among non-survivors.~   "
199478|NCT00951691|"~     This study will develop and test a new program of enhanced medical rehabilitation for elderly~     people who have had an acute disabling medical event and are admitted to a skilled nursing~     facility for post-acute rehabilitation.~   "
199479|NCT00951678|"~     Central venous catheterization is a common and important procedure done in the emergency~     department. The internal jugular vein (IJV), subclavian vein (SV) and femoral vein (FV) are~     commonly used for central venous access. Unfortunately, this procedure has high-risk~     complications.~      Traditionally, physicians have relied on the use of anatomic landmarks and physical~     manipulation such as moving the head or rotating the leg in order to place central catheters;~     however, studies have demonstrated that significant anatomic variations exist within large~     percentages of study populations. In addition, although studies have demonstrated that the~     use of ultrasonography for placement of femoral catheters leads to lower rates of~     complications, no previous studies have specifically determined anatomic variations in the~     femoral triangle. Therefore, this study will examine the anatomic variation of the IJV vs.~     carotid artery and the femoral vein vs. femoral artery in the emergency room setting. The~     investigators will study the variation as a function of sex, age, race, body habitus and~     degree of head rotation (measured using a goniometer) and in doing so, the investigators will~     demonstrate the utility of using ultrasound to place central lines in order to decrease~     morbidity.~   "
199480|NCT00951665|"~     This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to~     evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine~     (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and~     pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive~     (HER2-positive), locally advanced or metastatic breast cancer.~   "
199481|NCT00951652|"~     This study will test a version of cognitive behavioral therapy for generalized anxiety~     disorders that incorporates interpersonal and emotional processing techniques.~   "
199482|NCT00951639|"~     The purpose of this study was to compare the acute effects of 5g of Cassia cinnamon, 50~     minutes of endurance exercise performed at 70% of the heart rate reserve (correlated to~     VO2max), and 5g of cellulose placebo on blood glucose, serum insulin and insulin sensitivity~     following an oral glucose tolerance test 3 hours after administration of each intervention.~   "
199483|NCT00951626|"~     RATIONALE: Visiting patients at home to teach them about self care after a stem cell~     transplant may be more effective than standard therapy in improving quality of life.~      PURPOSE: This clinical trial is studying home visits to see how well they work compared with~     standard therapy in treating patients undergoing donor stem cell transplant for hematologic~     cancer.~   "
199484|NCT00951613|"~     The purpose of this study is to determine whether NK012 is safe and effective in the~     treatment of relapsed small cell lung cancer.~   "
199485|NCT00951600|"~     The study was conducted as an open label, balanced, randomized, two-treatment, two-period,~     two-sequence, single- dose, crossover bioavailability study comparing oxcarbazepine 300~     mg/5mL oral suspension of OHM Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc.)~     with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis~     Pharmaceutical Corporation in healthy, adult, male, human subjects under fasting conditions.~   "
199486|NCT00951587|"~     The purpose of this study is to evaluate the effect of the night procedure in regards to~     colon cleansing level and capsule excretion rate.~   "
199487|NCT00951574|"~     In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal~     (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy~     will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in~     double-blind conditions to a treatment with subcutaneous low molecular weight heparin~     (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy~     or up to a maximum of 4 months (+/- 10 days).~   "
199488|NCT00951561|"~     The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in~     women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject~     was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their~     treatment for two intervals.~   "
249890|NCT00281541|"~     A study with YM155 for the treatment of unresectable stage III or metastatic stage IV~     melanoma.~   "
199490|NCT00951535|"~     This is a prospective, phase II non-randomised controlled clinical study. Dose escalation~     will be implemented using 1.8 Gy increments from baseline 75.6 Gy. Patients' RT prescription~     may be escalated up to max 81 Gy once dose volume constraints are adhered to.~      All patients will be treated using the participating institution's standard rectal~     preparation protocol, bladder-filling protocol and appropriate immobilisation device(s).~      Cone beam CT on-treatment imaging is recommended for this study. However, the use of~     individual institutional imaging equipment and techniques is permitted.~      Acute GU/GI toxicities will be assessed weekly during treatment.~      GU/GI toxicities will also be assessed 2 months post RT, 8 months post RT and 6 monthly~     thereafter to year nine and in line with the participating institution's standard routine~     follow-up (FU) thereafter.~   "
199491|NCT00951522|"~     The purpose of this study is to evaluate the safety and tolerability of escalating doses of~     GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore~     airway hydration and mucociliary clearance in the lung.~   "
199492|NCT00951509|"~     The purpose of this research study is to examine whether computer based or virtual reality~     based driving assessments are as useful as real-world power wheelchair driving tests in~     measuring driving performance and whether they may be useful in helping to identify the~     problems that some individuals may have with driving power wheelchairs. The specific aims are~     as follows:~      Specific Aim 1: To develop computer-based and VR-based wheelchair driving assessments for~     both drivers and non-drivers that correspond to an accepted real-world driving assessment~     (Power Mobility Road Test) and compare them to the real-world assessment and to each other.~      Specific Aim 2: To develop additional features of the computer-based and VR-based assessments~     that present dynamic tasks and determine whether skills on these tasks can be delineated~     within the virtual environment.~   "
199493|NCT00951496|"~     This randomized phase III trial studies bevacizumab and intravenous (given into a vein)~     chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (given~     into the abdominal cavity) chemotherapy in treating patients with stage II-III ovarian~     epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal~     antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread by~     blocking the growth of new blood vessels necessary for tumor growth. Drugs used in~     chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing. It~     is not yet known whether giving bevacizumab together with intravenous chemotherapy is more~     effective than giving bevacizumab together with intraperitoneal chemotherapy in treating~     patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.~   "
199494|NCT00951483|"~     No suitable treatment has been identified to reverse and ideally prevent, the cardiovascular~     disease risk associated with depression and anxiety. The purpose of this study is to~     determine if quetiapine treatment of depression can reverse the signs of arterial stiffening~     that often occurs in depression and anxiety, and which are believed to be risk factors for~     future heart disease.~   "
199495|NCT00951470|"~     Objectives:~      Specific Aim 1: Estimate the prevalence of head and neck lymphedema in patients who have been~     treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and~     oropharyngeal cancer.~      Compare functional outcomes in patients with and without lymphedema using cross-sectional~     survey methods.~      Specific Aim 2: Evaluate the effect of Complete Decongestive Therapy (CDT) provided in an~     outpatient setting or a home-based program in reducing lymphedema in patients previously~     treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and~     oropharyngeal cancer at 1, 3 and 6 months follow-up. Patient characteristics, treatment~     variables, and the health care environment will be analyzed as possible explanatory variables~     that influence the effect of lymphedema treatment.~      Specific Aim 3: Evaluate the effect of lymphedema treatment on symptom burden, self-image,~     and functional performance status in patients previously treated with surgery and/or~     radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer.~   "
199496|NCT00951457|"~     The primary objective of this study is to determine the percentage of patients achieving a~     response, defined as the percentage of patients achieving complete response, partial response~     and stable disease/ no change upon treatment with the combination therapy according to NCI~     response criteria (also established according to IWCLL guidelines) upon treatment with a~     combination of bendamustine and alemtuzumab.~   "
199497|NCT00951444|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as MK-0646, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known~     whether gemcitabine hydrochloride and carboplatin are more effective when given together with~     or without MK-0646 in treating patients with non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying how well gemcitabine hydrochloride and~     carboplatin work when given together with or without MK-0646 as first-line therapy in~     treating patients with stage IIIB or stage IV non-small cell lung cancer.~   "
199519|NCT00951158|"~     It has become apparent that many cancers depend on specific fats (lipids) for their continued~     growth. Conjugated linoleic acid (CLA) is a safe, popular, and well-tolerated dietary~     supplement that promotes weight loss and loss of fat. CLA was recently shown to block the~     metabolism (uptake and production) of lipids required for growth of some cancers, resulting~     in killing of cancer cells. The investigators will conduct a clinical trial to test whether~     oral CLA blocks metabolism of lipids in patients with advanced cancers. Since the dose of CLA~     that may do this is not yet known, the investigators will start at a dose of CLA known to be~     tolerable and effective for weight loss. If this dose does not block lipid metabolism, the~     investigators will test higher doses in successive groups of patients until the investigators~     identify an effective dose, unless the investigators find that these higher doses cannot be~     tolerated. In order to verify that CLA is absorbed, it is necessary to measure CLA levels in~     blood before and after doses are given. Likewise, in order to verify that CLA blocks lipid~     metabolism, the investigators will need to obtain small samples of abdominal fat (and, in~     some patients, samples of tumors).~   "
222098|NCT00651638|"~     To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as~     defined by CYP 2C19 genotype~   "
199498|NCT00951431|"~     Functional dyspepsia is one of the most common digestive disorders. The pathophysiology of~     functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the~     first line treatment for functional dyspepsia. However, the mechanism of symptom relief is~     unclear. Most of the previous studies were performed on healthy volunteers who received only~     a very short course of PPI. The correlation between symptom and gastric emptying is lacking~     in these studies.~      Demographic data and anthropometric measurements will be obtained for baseline assessment.~     Patients are required to complete FGI Screening Questionnaire, Functional dyspepsia symptom~     questionnaire, gastroesophageal reflux disease (GERD) symptom questionnaire and irritable~     bowel syndrome (IBS) symptom questionnaire to have a thorough assessment of their GI~     symptoms. (1) Satiety test and ghrelin profile, and (2)gastric emptying test will be arranged~     as two individual visits.~      After baseline investigations, patients will be randomly assigned to either Nexium 20 mg~     daily or identical looking placebo for 8 weeks. The patients will report their individual~     dyspeptic symptoms on weekly basis using a self-administered symptom questionnaire.~      Satiety test and ghrelin profile, gastric emptying study will be repeated at the end of~     8-week treatment.~      Hypothesis: Long-term PPI relieves dyspeptic symptom through acceleration of gastric emptying~     rate.~   "
199499|NCT00951418|"~     This study aim to investigate the relationship between serum levels of clozapine and~     cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine~     monotherapy. The hypothesis is that higher serum levels of clozapine are associated with~     cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine~     are studied. The design is cross-sectional.~   "
199500|NCT00951405|"~     This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical~     trial is to investigate the safety and the efficacy of a prophylactic treatment option with~     long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.~   "
199501|NCT00951392|"~     An increase of longevity and of the number of men and women older than 60 years old is~     observed in most industrialized countries. Aging is a complex, multifactorial and continuous~     process involving physical and biological modifications such as a notably decrease in glucose~     tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult~     mainly because of many confounding factors (environment, lifestyle).~      In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in~     former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to~     study the link between a low antioxidant intake and risk of cancer or ischemic heart disease.~     The subjects recently had a health check-up including complete information about their diet,~     physical and neurosensory status. Based on these data, a score was established to classify~     subjects according to their quality of aging (successful aging versus problematic aging)~     These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute~     the reference population to determine the mechanisms involved in the insulin resistance~     development in aging.~      The purpose of our research work is to determine whether the quality of aging could influence~     insulin sensitivity, by studying metabolic profile and change in gene expression (genes~     involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.~   "
199502|NCT00951379|"~     The goal of this clinical research study is to learn how Actos (pioglitazone) may affect oral~     premalignant lesions (OPLs) and/or the risk of mouth cancer. The safety of this drug will~     also be studied.~   "
199503|NCT00951366|"~     The goal of the Bronchopulmonary Dysplasia (BPD) Patient Registry is to collect data on~     individuals with neonatal lung disease to better understand the illness and ultimately~     improve their care and survival. The Patient Registry was established in 2008 as a means to~     monitor important trends in the BPD population and to improve understanding, treatment, and~     survival.~   "
199504|NCT00951353|"~     Transplantation is the preferred method of treatment for end-stage renal disease (ESRD) in~     children. Over the past forty years, the use of newer immunosuppressive drugs has decreased~     the risk for organ rejection considerably, and improved short-term outcomes. However, these~     costly and complicated life-long treatment regimens also cause serious side effects. This has~     been particularly true for children, who undergo treatment with these drugs at the same time~     they are transitioning, physically and emotionally, from childhood to adulthood. These~     factors lead to significantly reduced life-spans, decreased drug regimen adherence, and an~     increased need for re-transplantation, as compared with adults.~      Current immunosuppressive procedures and strategies for children mimic those for adults,~     despite the difference between the two populations' immune systems and needs. New strategies~     aimed at tailoring to an individual child's needs would both reduce the risk of complications~     and improve outcomes. The purpose of this study is to generate information which will help to~     change the current practice of pediatric transplantation into one that is more individualized~     and preventative.~   "
199505|NCT00951340|"~     This study will test the feasibility and safety of adding interpersonal and emotional~     processing techniques to standard cognitive behavioral therapy for generalized anxiety~     disorder.~   "
199506|NCT00951327|"~     Patients with primary sclerosing cholangitis (PSC) are affected by an inflammatory condition~     of the bile ducts. Unfortunately, patients with PSC have a 10 to 15 percent lifetime risk of~     developing gallbladder and bile duct cancers. Gallbladder and bile duct cancers have a~     five-year survival of only 5 to 10 percent. Surgery to provide a cure must remove all cancer~     confined to one area.~      In order to increase survival rates there is a need to identify cancer and pre-cancer early.~     This has been difficult to do.~      Patients who have lab tests, positive imaging tests or obstructions will usually have a test~     called ERCP (Endoscopic Retrograde Cholangiopancreatogram) to take biopsies and enlarge bile~     ducts or opening bile ducts with stents. Patients usually have cells in the bile ducts~     removed and analyzed, but there are not studies to show how sensitive this may be to~     determine if the cells are cancer or pre-cancerous. A new scope with a system using light~     filters called Narrow Band Imaging (NBI) may help detect cancer and pre-cancer more often and~     at an earlier stage.~   "
199520|NCT00951145|"~     This is a retrospective/prospective study evaluating the clinical and radiographic outcome of~     total hip arthroplasty (THA) performed using Accolade femoral stem in a consecutive group of~     patients. All patients eligible for inclusion will be identified. The investigators~     hypothesize that the outcome of THA performed using Accolade femoral stem is equal or~     superior to historical survivorship of THA using other types of collarless, proximally~     coated, tapered stems.~   "
199507|NCT00951314|"~     Objective:~      Cocaine addiction continues to be an important public health problem with over 1.7 million~     users in the US alone. Cocaine addiction is characterized by compulsive drug use despite~     adverse consequences and high rates of relapse during periods of abstinence. Cocaine~     addiction may be mediated by neuroadaptations in reward-related learning and memory processes~     in the mesocorticolimbic dopamine system and glutamatergic corticolimbic circuitry.~     Metabotropic glutamate subtype 5 receptors (mGluR5) likely play essential roles in mediating~     some of the actions of drugs of abuse. Animal studies have shown that mGluR5 knock-out or~     blockade reduces self-administration of cocaine and cocaine-induced hyper-locomotion.~     However, to what extent mGluR5 are involved in the pathophysiology of cocaine addiction in~     humans is currently unknown, partly due to the lack of suitable methods to reliably quantify~     mGluR5 in the living human brain.~      This protocol aims to determine whether the density of mGluR5 in brain is altered in~     participants with cocaine addiction compared to healthy controls using positron emission~     tomography (PET) and the recently developed radiotracer for mGluR5, [18F]SP203. We also aim~     to determine whether this density is related to genotype, history of cocaine use, and/or~     craving for cocaine.~      Study Population:~      The study populations will consist of healthy adults with no history of substance abuse and a~     matched group of healthy current primary cocaine dependent male and female participants~     (20-50 years old.; N=40/group).~      Design:~      Density of mGluR5 will be measured in cocaine dependent participants and healthy adults~     volunteers with PET and (18F)SP203, a radioligand with specificity for mGluR5. All~     participants will undergo genotyping to identify normal or variant mGluR5 gene associated~     with drug abuse. The intensity of craving for cocaine will be assessed while watching a video~     about cocaine use.~      Outcome measures:~      Density of mGluR5 will be compared between cocaine dependent participants and healthy~     controls. In addition, correlation among the genetic polymorphism, the craving response, and~     the density of mGluR5 will be determined.~   "
199508|NCT00951301|"~     This study is being done to see if the addition of mangosteen juice to standard medical care~     will reduce the risk of atrial fibrillation (AF) recurrence following direct current (DC)~     cardioversion. The study will also look at the effects the mangosteen juice may have on~     biomarkers of inflammation and endothelial cell dysfunction (the tissue lining the arteries~     does not function properly).~   "
199509|NCT00951288|"~     This is a pilot interventional study whose aim is to determine the effect of a dietary~     supplementation with a Crocus Sativus extract, Saffron, on macular cone-mediated function in~     patients with early age-related macular degeneration (AMD). Pre-clinical evidence ( Maccarone~     R, Di Marco S, Bisti S. Saffron supplement maintains morphology and function after exposure~     to damaging light in mammalian retina. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1254-61.)~     indicates the potential effectiveness of Saffron as a retinal neuroprotectant in animal~     models of retinal degenerative disorders.The macular function will be tested by visual acuity~     and macular cone-mediated electroretinogram (focal electroretinogram, FERG) according to a~     standardized technique (see citations).~   "
199510|NCT00951275|"~     This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying~     Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe~     active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs~     will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6~     months. The anticipated time on study treatment is 3-12 months, and the target sample size is~     100-500 individuals.~   "
199511|NCT00951262|"~     This study aims to develop a life review program and test its effectiveness on a sample of~     patients with advanced cancer patients receiving palliative care at home in Fuzhou.~   "
199512|NCT00951249|"~     It has been estimated that black men who have sex with men (MSM) account for one quarter of~     all new HIV infections in the US annually, yet little prevention work has been directed~     towards this population. The purpose of this study is to research and potentially design a~     new and better way to try and slow the spread of HIV among black MSM.~   "
199513|NCT00951236|"~     Trigger finger, also known as stenosing tenosynovitis, is a painful condition that can cause~     discomfort and disability. Many physicians choose to locally inject cortisone into the~     infected finger although there is no current consensus as to how many injections are needed~     to achieve maximum relief. This study will be a prospective, randomized study to compare one~     versus two injections for the treatment of trigger finger.~   "
199514|NCT00951223|"~     This observational prospective registry is designed to evaluate the safety, adherence, and~     efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1)~     and other prescribed therapies in patients chronically infected with HCV. The primary~     endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends.~   "
199515|NCT00951210|"~     The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections~     for the treatment of CLI patients.~   "
199516|NCT00951197|"~     Capturing the earliest stages of Dementia especially Alzheimer's Disease (AD) is a great~     challenge. Until now the NINCDS-ADRDA and the DSM criteria for AD were largely used as~     diagnostic standards in research. However, the research on AD progresses and some biomarkers~     have been recently suggested to improve the diagnostic criteria of AD, such as cerebrospinal~     fluid markers, neuroimaging with Positon Emission Tomography (PET) or Magnetic Resonance~     Imaging (MRI).~   "
199517|NCT00951184|"~     RATIONALE: Gathering information about depression in patients with cancer may help doctors~     learn more about the disease and plan the best treatment.~      PURPOSE: This clinical trial is studying depression screening in patients undergoing~     radiation therapy for cancer.~   "
199518|NCT00951171|"~     Study Hypothesis: There is a difference in pregnancy rates between intrauterine insemination~     (IUI) in cycles performed with cervical occlusion by a balloon catheter designed for~     sonohysterograms as compared to those performed with a standard inseminator.~      The investigators will compare pregnancy rates in patients undergoing routine IUI either with~     balloon occlusion or with standard insemination. The patients will receive the standard~     clinical care per the investigators' office guidelines, except they will be randomized to~     insemination with either of two catheters.~   "
199521|NCT00951132|"~     The purpose of this study is to investigate whether rosuvastatin decreases measures of~     inflammation in depressive patients.~   "
199540|NCT00950885|"~     Melatonin supplements have been reported to be an effective treatment for circadian rhythm~     sleep disorders, including shift work dyssomnia, jet-lag, delayed sleep phase syndrome, and~     sleep disruption suffered by many blind individuals. However, the mechanism(s) by which~     melatonin affects the timing of sleep are not well-understood. The purpose of this study is~     to determine if melatonin improves sleep and performance on a schedule simulating eastward~     travel. This study will provide information regarding the mechanism of action of melatonin~     that will be critical for the use of melatonin as a treatment for circadian rhythm sleep~     disorders.~   "
199541|NCT00950872|"~     The objectives of this clinical trial are the overall performance and safety of the ENDO GIA~     Staplers with ENDO GIA SULUs with Duet TRS TM.~   "
199522|NCT00951119|"~     Rationale: Hypertension is an important risk factor of cardiovascular disease, especially in~     patients with type 2 diabetes mellitus (T2DM). A relatively recent development for the~     treatment of hypertension is the use of breathing exercises. The investigators' previous~     studies with a breathing device did not show any positive results. However, these studies and~     other trials investigating the effects of breathing devices had not a double-blind design.~     Therefore, the investigators want to perform a randomized, double-blind, controlled trial in~     a population of T2DM patients.~      Objective: To determine the effect of a device slowing breathing (Resperate©) on office~     systolic blood pressure (SBP) in diabetic patients with treated hypertension with moderate BP~     control.~      Study design: A randomized, double-blind, controlled trial.~      Study population: Patients with type 2 diabetes mellitus, over 18 years old and a baseline~     systolic blood pressure between 140-160 mm Hg.~      Intervention: One group receives treatment with a breathing device (Resperate©) and the other~     group receives treatment with a control breathing device. The latter device does not try to~     alter the breathing pattern.~      Main study parameters/endpoints: The effect of the breathing device on SBP is the main study~     parameter. Secondary endpoints include diastolic blood pressure (DBP) and quality of life.~   "
199523|NCT00951106|"~     The purpose of this study is to determine the efficacy of pyrimethamine/sulfdoxine~     (Fansidar®) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.~     Reports in the mid 1990s indicated that Fansidar was failing to cure patients with confirmed~     falciparum malaria. The study design was based on accepted WHO parasitological and clinical~     outcomes to determine the overall efficacy of Fansider and inform the Peruvian National~     Malaria Control authorities as to the continued wisdom of recommending Fansidar as first line~     treatment for uncomplicated falciparum malaria in the Peruvian Amazon.~   "
199524|NCT00951093|"~     The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal~     reflux disease (GERD) in morbidly obese patients.~   "
199525|NCT00951080|"~     The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT)~     device called the SNaP device compared to a traditional NPWT device for the treatment of~     lower extremity diabetic and venous ulcer wounds.~   "
199526|NCT00951067|"~     The purpose of this study is to determine how well different treatments for acquired~     lymphedema work.~      The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm~     to see which treats lymphedema best.~   "
199527|NCT00951054|"~     The purpose of this study is to determine whether NK012 is safe and effective in the~     treatment of advanced and metastatic triple negative breast cancer.~   "
199528|NCT00951041|"~     The purpose of the study is to evaluate the safety and immunogenicity of GSK Biologicals'~     influenza vaccine GSK2340272A.~   "
199529|NCT00951028|"~     This study will test a therapy for both helping people adhere to their HIV medication~     regimens and treating them for depression.~   "
199530|NCT00951015|"~     This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal~     once daily dose of GSK1349572 from a range of doses for future evaluation.~   "
199531|NCT00951002|"~     The purpose of this study is to determine whether human acellular dermal matrix plug is~     effective in the treatment of anal fistula~   "
199532|NCT00950989|"~     Randomized, double-blind, placebo-controlled study in subjects with RA who have an inadequate~     response to methotrexate.~   "
199533|NCT00950976|"~     To determine the level of citrulline to produce a given amount of arginine in healthy~     volunteers and surgical patients. Arginine-related amino acids are expected to increase as a~     result of increased substrate provided by citrulline.~   "
199534|NCT00950963|"~     The current project is evaluating the effect of a nurse-administered phone care in diabetes~     to improve access to care and healthcare delivery. The setting is a federally qualified~     community health center serving over 1600 diabetic patients, 80% of whom are Latino. Using~     our diabetes registry, we have randomly assigned 762 patients to either participate in a~     telephone-based, nurse-run outreach program (N=381) or to continue with usual care(N=381).~     Three of our registered nurses learned algorithms addressing management of cholesterol, blood~     pressure, kidney disease, aspirin use, eye screening, and pneumovax and influenza vaccines.~     The program began recruitment in September 2005 and has finished follow up in May 2007. The~     program initially focused only on cholesterol management utilizing national guidelines and~     algorithms on patients with elevated cholesterol (LDL) levels but has expanded to include~     glycemic and blood pressure control. We found that Registered Nurses were able and willing to~     provide telephone care to diabetic patients according to moderately complex algorithms and to~     track patient data electronically with overall job satisfaction. Overall, the nurses have~     expressed enthusiasm but have also experience frustrations with maintaining contact and~     improving motivation in patients. The impact of this program on diabetes outcomes and its~     cost-effectiveness is currently being analyzed with the goal of implementing this program in~     our institution.~   "
199535|NCT00950950|"~     The purpose of this study is to evaluate the effect of AMG 785 on parameters of bone quality~     of the forearm using peripheral Quantitative Computed Tomography (pQCT) following multiple~     subcutaneous dose administrations of AMG 785 in postmenopausal women with low bone mass.~   "
199536|NCT00950937|"~     The purpose of this study is to compare oxidative stress markers and the immunologic~     characteristics of HIV-infected and non-HIV subjects during a bout of moderate aerobic~     exercise followed by resistance exercises~   "
199537|NCT00950924|"~     Axial hyperopia results when the length of the eye is too short for the eye to properly focus~     distance objects on the retina while the focusing system is relaxed. Emmetropization is the~     process by which the eye actively adjusts various components of the eye to gradually improve~     the focus of the eye. Emmetropization frequently involves either an increase or a decrease in~     the growth of the eye, particularly during infancy and childhood. Numerous animal studies~     suggest that if an animal is exposed to retinal images located behind the retina either~     centrally or peripherally, the eye will grow in the direction of the focused image. If an~     abnormally short eye has resulted in hyperopia, exposing such an eye to retinal images~     partially located behind the retina might encourage axial elongation, thus reducing the~     hyperopia.~   "
199538|NCT00950911|"~     The purpose of this study is to describe the safety and tolerability of denosumab~     administration as measured by adverse events, immunogenicity, and safety laboratory~     parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.~   "
199542|NCT00950859|"~     Integrase is an enzyme produced by HIV so that the virus can multiply in the human body.~     GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from~     working properly and therefore prevents the virus from multiplying.~      GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in~     adults with no previous exposure to integrase inhibitors. The purpose of this study is to~     determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no~     longer respond to treatment with the approved integrase inhibitor raltegravir and carry~     viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily~     in combination with the background HIV drugs previously administered (unless discontinuation~     of a particular drug is required) will be assessed over 10 days (functional monotherapy~     phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new~     optimised background regimen from Day 11 through at least Week 24.~   "
199543|NCT00950846|"~     The purpose of this study is to determine the safety and effectiveness of Umbilical Cord~     Blood Transplant (UCBT) to treat the patient's disease, and to see if this treatment can~     decrease the incidence of GVHD.~      This study is for patients that were born with a disease that affects their body's metabolism~     or immune system. The doctor plans to treat the patient for this illness with a stem cell~     transplant.~      While improved medical care has allowed many people with these diseases to live longer, the~     only way to truly cure the diseases is by means of a stem cell transplant from a donor who~     does not have the disease. A stem cell transplant will replace sick cells with new healthy~     donor cells. Stem cells grow into different types of blood cells that people need, including~     red blood cells, white blood cells, and platelets. In a stem cell transplant, the patients~     own stem cells would be killed by chemotherapy drug and then replaced by stem cells from the~     donor. Stem cells can be collected from the bone marrow, peripheral blood or umbilical cords.~     In this study, umbilical cords will be the source of the stem cells.~      Currently, large inventories of umbilical cord blood units are available in public banks for~     transplantation in those lacking bone marrow donors. UCB transplants offer several advantages~     over adult bone marrow or peripheral blood stem cell transplants, including:~        1. Rapid availability,~        2. Absence of donor risk,~        3. Low risk of transmissible infectious diseases,~        4. Low risk of acute GvHD (as compared to recipients of unrelated donor marrow and~          peripheral blood cells).~      The two main causes of death after umbilical cord blood transplantation for disorders for~     these kinds of patients, are graft failure and infection.~      In this study we are trying to address these two problems by using different drugs to prepare~     patients for the transplant.~      To help improve engraftment (cells begin to grow), we will include the drug Fludarabine to~     the usually used Busulfan and Cytoxan that the study patients will receive before their~     transplant.~      We will try to decrease the chance of developing graft-versus-host disease (GvHD) by using~     Cyclosporin A (CSA) and Mycophenolate Mofetil (MMF), instead of Anti-Thymocyte Globulin (ATG)~     which is normally used.~   "
199544|NCT00950833|"~     The objective of this study is to evaluate the immune memory through the administration of an~     additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody~     persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H.~     influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate~     vaccine GSK1024850A in previous primary and booster studies. For subjects that did not~     receive the investigational vaccine during the primary and booster study, the objective is to~     evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK~     Biologicals' pneumococcal conjugate vaccine GSK1024850A.~      This protocol posting deals with objectives & outcome measures of the extension phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT00370318). The objectives & outcome measures of the booster phase are presented~     in a separate protocol posting (NCT00496015).~   "
199545|NCT00950820|"~     The purpose of this interventional study is to investigate whether there is evidence that~     panitumumab in combination with XELOX (capecitabine plus oxaliplatin) chemotherapy will~     safely increase progression-free survival, above that of XELOX alone in subjects with KRAS~     wild-type metastatic colorectal cancer who have not responded to or progressed after first~     line therapy with irinotecan and a fluoropyrimidine.~      Further Objectives Exploratory objectives may include investigation of potential correlations~     between the treatment regimen and epidermal growth factor receptor (EGFR) expression,~     detection of the functional genetic polymorphisms of the EGFR gene, EGFR gene amplification~     (FISH), EGFR downstream protein and gene expression parameters, proteomics and epigenetics.~   "
199546|NCT00950807|"~     The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared~     with placebo in subjects with COPD.~   "
199547|NCT00950794|"~     To demonstrate the efficacy (non-inferiority) of Salmeterol 50mcg bid (100mcg/day), compared~     with Hokunalin (tulobuterol) tape 2mg once a day, in terms of improvement in pulmonary~     function (peak expiratory flow: PEF) in a randomized, double-blind, parallel-group~     comparative study in adult patients with bronchial asthma on ICS 400mcg/day of FP equivalent.~   "
199548|NCT00950781|"~     This is an ancillary study to Protocol 16997 to examine the stress hormone level in women~     with menopausal symptoms. This ancillary project will collect additional data from the 45~     subjects enrolled in Protocol 16997 (no subjects have enrolled in Protocol 16997 so far).~     This study protocol differs from the main protocol (16997) because it will include an ACTH~     (Hormone) Stimulation Test which will assess the functioning of stress response in the~     subjects at entry and exit.~      Subjects will undergo the ACTH test for this ancillary protocol in the morning when they~     complete 24-hour urine collection for Protocol 16997. The ACTH (Hormone) Stimulation Test~     will not be done in the main protocol 16997. During the ACTH test an IV will be placed in~     subjects arms, 25mL of blood will be drawn at -30 minutes and 6mL of blood will be drawn at~     -15 minutes and 0 minutes respectively. Following, 0.25mg of ACTH will be injected~     intravenous over 60 seconds, and a final 12mL of blood will be drawn 60 minutes later. That~     is, a total of 50mL of blood will be drawn to test serum blood hormone levels from the~     subjects during the ACTH (Hormone) Stimulation Test.~      The 24 hour cortisol data collected in the main protocol 16997 will be used for this study~     analysis.~      When subjects are consented for Protocol 16997, they will also be consented for this~     ancillary study. In addition to the consent visit, subjects will have two study specific~     visits (entry and exit) for this ancillary study. The PI will schedule the specific visits~     for this study to be in conjunction with those scheduled for Protocol 16997.~      There is no collaborations with other sites in the ancillary study.~   "
199580|NCT00950365|"~     RATIONALE: Erlotinib may stop the growth of tumor cells, and even shrink the tumors in some~     patients, by blocking some of the enzymes such as epidermal growth factor receptor (EGFR)~     needed for cell growth and spread. Pemetrexed is a drug that inhibits several key proteins~     that require folic acid to synthesize DNA. Blocking DNA synthesis in tumor cells has been~     shown to decrease tumor growth. can block tumor growth in different ways. Giving erlotinib~     together with pemetrexed at a specific schedule may kill more tumor cells than giving only~     pemetrexed.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and~     cetuximab and to see how well they work in treating patients with advanced solid tumors or~     progressive or recurrent stage III or stage IV non-small cell lung cancer.~   "
199549|NCT00950768|"~     In this study will be randomised before induction treatment either to receive two courses of~     melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent~     will be obtained upon enrolment. Inclusion criteria included: diagnosis of untreated Durie e~     Salmon stage IIA-IIIB measurable multiple myeloma; age < 65 years. Exclusion criteria~     included: prior treatment for myeloma; abnormal cardiac function, defined as systolic~     ejection fraction <50%; abnormal pulmonary spirometry test; serum bilirubins > 2.5 times~     normal and ALAT and/or ASAT > 2 times normal; seropositivity for HIV, HCV or HBV, active~     non-hematologic malignancies.~      Induction therapy, PBSC mobilization, and autografting Initial treatment plan included~     induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2~     on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by~     peripheral blood stem cell (PBSC) mobilisation and harvest after 1 or 2 cycles of~     cyclophosphamide, 4 g/m2, and G-CSF, 10 ug/kg given i.v. or subcutaneously. After at least~     one month from PBSC collection, autografting consisted of melphalan, 200 mg/m2 or melphalan,~     100 mg/m2, on day -2, and cryopreserved PBSC infusion on day 0. Patients received G-CSF, 5~     ug/kg, from days +3 until neutrophil count > 1000/ul were achieved.~      Supportive care and toxicity grading Following autografting, all patients received standard~     prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster~     virus reactivation; and Pneumocystis carinii. Cytomegalovirus CMV reactivation was monitored~     through levels of CMV antigenemia and/or serum CMV DNA levels and treated with ganciclovir or~     foscarnet as clinically indicated. Standard criteria (Common Toxicity Criteria version 3.0)~     were used for grading hematological and non-hematological toxicity.~   "
199550|NCT00950755|"~     This is a single-arm, open-label study of Iodine 131 Anti B1 Antibody for the treatment of~     1st or 2nd relapsed indolent B cell lymphomas or B cell lymphomas that have transformed to a~     more aggressive histology. The primary endpoint of the study is to determine the response~     rate. Secondary endpoints of the study is to determine the duration of response, time to~     progression, time-to-treatment failure, safety, and survival.~      Forty patients will receive therapy on this study at the 2 clinical sites. Patients will~     undergo 2 phases of the study. In the first phase, termed the dosimetric dose, patients~     will receive an infusion of unlabeled Anti B1 Antibody (450 mg) over 70 minutes (including a~     10 minute flush) immediately followed by a 30 minute infusion (including a 10 minute flush)~     of Anti B1 Antibody (35 mg) which has been trace-labeled with 5 mCi of Iodine 131. Whole body~     gamma camera scans will be obtained on 1) Day 0; 2) Day 2, 3, or 4; and 3) Day 6 or 7~     following the dosimetric dose. Using the dosimetric data from the 3 imaging timepoints, a~     patient-specific dose of Iodine 131 Anti B1 Antibody to deliver the desired total body dose~     of radiotherapy will be calculated. In the second phase, termed the radioimmunotherapeutic~     dose, patients will receive a 70 minute infusion (including a 10 minute flush) of unlabeled~     Anti B1 Antibody (450 mg) immediately followed by a 30 minute infusion (including a 10 minute~     flush) of 35 mg Anti B1 Antibody labeled with the patient-specific dose of Iodine 131 to~     deliver a whole body dose of 75 cGy to patients with no hematologic risk factors. Patients~     who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy and patients who~     are obese will be dosed based upon 137% of their lean body mass (see Appendix A). Patients~     will be treated with either saturated solution potassium iodide (SSKI), Lugol's solution, or~     potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine~     131 Anti B1 Antibody and continuing for 14 days following the last infusion of Iodine 131~     Anti B1 Antibody (i.e., therapeutic dose).~   "
199551|NCT00950742|"~     Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with~     Herceptin®~   "
199552|NCT00950729|"~     Abstract Background: Effects of orthopedic immobilizations of the lower right limb on driving~     performances are unknown. Therefore, clinicians and legislators cannot put forth~     recommendations for road safety for patients requiring such immobilizations. The objective of~     the present study was to evaluate the effects of different orthopedic immobilizations on~     braking performances in simulated driving conditions.~      Methods: The braking performances of 48 healthy volunteers were evaluated under 3 conditions:~     wearing their running shoes, and 2 types of orthopedic immobilizations of the lower right~     limb, a walking cast and an Aircast walker. A computerized driving simulator was used to~     measure the maximum force applied on the brake pedal during braking, the braking reaction~     time and the total braking time during emergency braking with and without a distracter.~   "
199553|NCT00950716|"~     Quality diabetes care requires informed-decisions of motivated care providers and diabetes~     patients. The investigators aim to use peer support and information technology to facilitate~     care providers to implement structured care and empower diabetes patients acquire~     self-management skills in a multi-component program.~      The investigators will make use of the following tools: (1) The Joint Asia Diabetes~     Evaluation (JADE) Program. JADE Program uses a web-based electronic portal to establish a~     registry and stratify diabetes patients to care protocols based on their risk profiles with~     features of decision support and data management. (2) The Australasian Telephone Linked Care~     (TLC) system. TLC system utilizes an automatic, interactive, computer-controlled telephone~     system to monitor and promote diabetes self-management.~      Amongst 600 diabetes patients receiving structured care in Hong Kong through the JADE~     Program, half of them will be randomized to receive peer support (n=300) including personal~     coaching by 30 trained mentors (1 mentor to 10 diabetes patients or mentees) through regular~     phone calls and sharing sessions, and the other half (n=300) will continue the usual diabetes~     care in their clinic. The 30 mentors are themselves diabetes patients who have good self care~     and are motivated to support their peers. The mentors will be trained to deliver peer support~     intervention under supervision by a program manager. The 300 diabetes patients (mentees)~     randomized to the peer support group are the intervention targets of these 30 mentors. They~     will be reminded to use the TLC for knowledge enhancement and motivational support.~      The investigators will analyse the changes in risk factor control (blood glucose parameters,~     blood pressure, body weight, lipids), quality of life and cognitive-psychological-behavioral~     parameters after 12 months. Effects of various components of peer support on these outcomes~     as well as user acceptability and cost-effectiveness of these programs will be examined.~      The investigators will test the hypothesis that in a multi-component program, the use of a~     peer support program delivered by diabetes patient-mentors, to influence and motivate other~     diabetes patients receiving structured care made possible through a web-based disease~     management program, delivered by a doctor-nurse team, will further improve metabolic control,~     QOL and self care compared to diabetes patients receiving the same standard of care.~   "
199554|NCT00950703|"~     1. Assessing the perception of Canadian Primary Care Physicians towards global~          cardiovascular risk assessment.~        2. Correlating physician perceptions to actual practice data, gathered via a retrospective~          chart audit.~        3. Evaluating the impact of a prospective educational and peer-practice pattern~          intervention on future assessment o cardiovascular risk and~        4. Assessing the role of carotid atherosclerosis assessment(Carotid IMT and plaque) as an~          adjunct to global risk prediction.~   "
199555|NCT00950690|"~     Efficacy data was not collected or analyzed. This study did assess safety and tolerability of~     Xalatan.~   "
199556|NCT00950677|"~     The purpose of this study is to see if giving study drugs before a meal may lower blood~     sugars after the meal. An improvement in blood sugar control may prevent long-term problems~     of diabetes.~   "
199557|NCT00950664|"~     1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in~          comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment~          of Cervical dystonia.~        2. double blind, randomised, multi center, crossover study~   "
199558|NCT00950651|"~     A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to~     compare the efficacy, safety, and clinical benefit of the test and reference product after~     treatment for 84 days in patients with osteoarthritis of the knee.~   "
199559|NCT00950638|"~     The objectives of this study are to evaluate the safety and tolerability of ARC1905~     intravitreous injection in subjects with geographic atrophy secondary to dry age-related~     macular degeneration (AMD).~   "
199581|NCT00950352|"~     The purpose of the study is to determine if citicoline (a nutritional supplement) is~     effective in helping people reduce their dependence on methamphetamine. The investigators~     will use neuroimaging to look at the structure and chemical make up of the brain at the start~     of the study and after 8-9 weeks of treatment of citicoline or placebo.~   "
249907|NCT00281320|"~     This study evaluates the safety and tolerability of Asenapine in elderly patients with~     psychosis.~   "
199560|NCT00950625|"~     Although laparoscopic cholecystectomy is associated with less pain than contemporary open~     procedures; it is definitely not pain free and the magnitude of postoperative shoulder and~     abdominal pain in the early postoperative period is still quite significant. This~     postoperative pain is a major concern not only for the patients, but also healthcare workers;~     and it often contributes to overnight hospital stay after this minimally invasive surgical~     procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to~     control pain after laparoscopic cholecystectomy has been extensively studied in numerous~     randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two~     commonly used local anesthetic agents. In view of contradictory results from previous~     studies, it is not yet clear which of these two agents is superior to the other for pain~     control in this setting. To answer this question, we have designed a prospective randomized~     controlled trial and the specific aim of the study is to compare the analgesic efficacy of~     intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting~     after laparoscopic cholecystectomy.~      If we can improve pain control after this minimally invasive procedure, it might result in~     decreased postoperative requirement of narcotic analgesia and its associated side-effects. It~     may also result in early recovery and the same day discharge of the patients with significant~     cost-containment for the patient and healthcare systems in future.~   "
199561|NCT00950612|"~     This observer blind study will assess the safety and immunogenicity of GSK Biologicals'~     investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a~     TB-endemic region.~   "
199562|NCT00950599|"~     To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects~     with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12~     weeks of double-blind treatment.~   "
199563|NCT00950586|"~     GSK1034702 is being developed for improving cognitive impairment in diseases such as~     Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no~     child beading potential to investigate repeated doses of the study medicine. The study will~     investigate the following questions, do repeated doses of the study medicine have any~     important side effects when taken by mouth? How much of the study medicine gets into the~     bloodstream, and how quickly does the body get rid of it? Does the study medicine affect~     memory, attention and problem-solving skills? What are the effects when the study medicine~     and dextromethorphan are taken together.~   "
199564|NCT00950573|"~     Objective:~        1. To assess whether nocturnal hemodialysis and renal transplantation are associated with~          less progression of coronary arterial calcification, compared with conventional~          hemodialysis and peritoneal dialysis;~        2. To identify the risk factors for coronary arterial calcification in dialysis and~          transplant patients, and to assess a possible interaction with treatment modality.~   "
199565|NCT00950560|"~     The authors employ a questionary approach to understanding the relational among patients'~     perceptions of inpatient, outpatient and emergency room service and their overall perceptions~     of service quality, satisfaction with hospital.The questionary was applied in total 300~     patients (100 inpatients, 100 outpatients and 100 emergency patients).~   "
199566|NCT00950547|"~     PURPOSE: Autotransfusion devices may be employed in cardiac surgery to decrease allogenic~     blood requirements. Limitations of previous trials include the use of cell saver systems in~     selected high risk patients only or the lack of blood transfusion-sparing strategies. The aim~     of this prospective randomized study is to evaluate the efficacy of cell salvage CardioPAT~     routinely used in cardiac surgery.~      METHODS: The investigators will randomize 350 patients in two groups: group 1 receives a~     CardioPAT cell saver device (175 patients), group 2 doesn't receive any cell saver device.~     The incidence of allogenic blood transfusion and clinical outcome in both groups are~     evaluated.~   "
199567|NCT00950534|"~     The primary objective is to demonstrate the improvement in glycosylated haemoglobin (HbA1c)~     levels after general practitioner (GP) initiation and management of type 2 diabetes mellitus~     (T2DM) with insulin glargine compared with their usual clinical practice.~      The secondary objective is to demonstrate the importance of GP initiation of insulin glargine~     for the treatment of T2DM.~   "
199568|NCT00950521|"~     The objective of the study is to determine the efficacy of brain transplants of CD34+ stem~     cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.~   "
199569|NCT00950508|"~     The aim of this study is to examine if high-volume plasma exchange has a positive effect on~     mortality in patients with acute liver failure.~   "
199570|NCT00950495|"~     The aim of the study was to compare the effects of a mandibular advancement device (MAD) with~     those of nasal continuous positive airway pressure(nCPAP) and of an intra-oral placebo device~     in obstructive sleep apnea (OSA) patients. The hypothesis for this study was that both MAD~     therapy and nCPAP therapy have similar, better treatment effects than placebo therapy in OSA.~     The study was performed according to the CONSORT (consolidated standards of reporting trials)~     statement (Altman et al., 2001), employing a parallel-group, randomized, placebo-controlled~     trial design.~   "
199582|NCT00950339|"~     Current guidelines recommend the addition of proton pump inhibitors (PPI) to patients taking~     double anti-platelet therapy (Aspirin and Clopidogrel) to prevent upper GI bleeding1. Many~     post percutaneous coronary intervention (PCI) patients are treated with dual anti-platelet~     medications as well as PPI to prevent upper GI bleeding.~      Recently, it was shown that PPI interact with the P450 system in the liver and reduce the~     platelet inhibitory effect of Clopidogrel2,3. Clopidogrel is activated by CYP2C19, which also~     metabolizes PPI4. Furthermore, a recent article showed increased mortality in patients taking~     PPI and clopidogrel compared with patients taking clopidogrel without PPI protection5. The~     degree of reduction in the platelet inhibitory properties of clopidogrel might vary among the~     different PPI4.~      The use of PPI for GI protection in patients treated with dual anti-platelet therapy is not~     based on randomized trials, but rather on expert opinion. Since H2 blockers are also~     effective in preventing acid secretion and are not known to interact with the P450 system~     that affects clopidogrel, the investigators hypothesized that these group of drugs will not~     interfere with the positive antiplatelet effects of clopidogrel and therefore will offer a~     good alternative treatment option.~   "
199736|NCT00948337|"~     The purpose of this study is to provide educational material to promote screening for second~     primary cancer for the intervention group, or educational material to instruct appropriate~     use of dietary supplement for the control group.~   "
199571|NCT00950482|"~     This pilot project is a randomized research study to examine the effects of acupuncture on~     menopausal symptoms. The investigators will recruit up to 45 Cedars employees (excluding Dr~     Bairey Merz's employees) with menopausal symptoms by posting a study flyer on Exchange. If a~     patient is interested in this study, she may contact the research team for further~     information. Once a patient is identified as being eligible for the study, she will be~     contacted to schedule the screening visit. They will receive an explanation of the study.~     They will be sent the consent form to review prior to the initial visit. At the initial~     visit, prior to any study-related procedures, the consent will be reviewed with the patient.~     After all questions have been answered and the patient appears to fully understand the study,~     the patient will be asked to provide written consent.~      This pilot project will collect data from three study groups as stated in the NIH application~     proposal. The first research study group will undergo traditional acupuncture (TA). The~     second research study group will receive alternative acupuncture (AA). The third group will~     be a waiting control group (WC) that will receive four weeks of acupuncture following~     completion of the study duration.~      Traditional acupuncture means that the needle is inserted in true acupuncture point~     locations. Alternative acupuncture is a technique that varies slightly from traditional~     acupuncture and is used to assess which technique, if any, produces the best therapeutic~     results. Waiting control is a group of subjects who get neither traditional nor alternative~     acupuncture during the duration of treatment, which in this case, is 3 months.~      Patients will be randomized into one of the three study groups, and will have one in three~     chance of being placed in one of the three groups. Neither patients nor the investigators can~     choose which group patients are assigned to. Patients from TA and AA groups will be asked to~     come to Cedars-Sinai a total of 39 times (36 sessions and 3 clinic visits) over a three-four~     month period. It will compare the effects (good or bad) of traditional acupuncture (TA) with~     alternative acupuncture (AA) on the menopausal symptoms to be studied in this research.~     Patients from WC group will be asked to come to Cedars-Siani a total of 15 times. Other study~     procedures include physical exam, blood and urine collection for hormone tests, questionnaire~     interview, etc.~      During the pilot phase of this study subjects will record the number of mild, moderate,~     severe and/or very severe hot flashes that occur each day in a hot flash diary. There is also~     an option for patients to record other symptoms they may experience during that week other~     then hot flashes as well as a place for additional comments. Subjects will complete the diary~     for seven consecutive days. It is a simple form that takes very little time to complete each~     day (only 5-10 minutes) and will not impact the duration of the study participation.~      No genetic study will be conducted in this pilot project.~   "
199572|NCT00950469|"~     OBJECTIVES/BACKGROUND: We sought to determine the early diagnostic value of the new high~     sensitive cardiac troponin T assay (TnThs) in suspected acute coronary syndrome (ACS) and to~     compare it with the 4th generation cTnT assay from the same manufacturer, myoglobin and~     heart-type fatty acid binding protein (h-FABP).~      METHODS: The study consisted of 94 patients with chest pain admitted to the chest pain unit~     with the diagnosis of suspected ACS without ST-Elevation. Patients were divided according to~     time from onset of symptoms to presentation into an early presenter group (<4 hours) and a~     late presenter group (≥4 hours).~      A median of 6 samples (range 2-8) were available per patient. The diagnostic performance of~     TnThs was assessed using ROC analysis and areas under the curve (AUC) of baseline and~     follow-up results of TnThs, cTnT, myoglobin, and h-FABP were compared using c-statistics.~      RESULTS: The TnThs assay allows an excellent prediction of non-ST-segment-elevation~     myocardial infarction (non-STEMI) at presentation.A follow-up sample improves diagnostic~     performance in a time dependent manner. The AUC of the TnThs was superior to cTnT at all time~     points.~      CONCLUSIONS: A baseline sample of TnThs allows an earlier prediction of non-STEMI than the~     less sensitive and precise 4th generation cTnT assay. The excellent performance of TnThs at~     baseline and follow-up might obviate the need for other early necrosis markers.~   "
199573|NCT00950456|"~     The purpose of this observational study, which will be initiated as soon as the licensed H1N1~     Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the~     incidence of any medically-attended adverse events in all vaccinated subjects.~   "
199574|NCT00950443|"~     Upper airway obstruction (UAO) is very common in children. Presently, the importance of the~     UAO is evaluated by the physician during an endoscopic evaluation under general anaesthesia.~      The aim of the study is to evaluate two new techniques to quantify the importance of the UAO~     in children; the acoustic reflection method and the measurement of the work of breathing.~      80 children will be included in this monocentric, prospective, open labelled study.~   "
199575|NCT00950430|"~     This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of~     this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to~     ascertain the relationship between change in amyloid burden over time, and concurrent change~     in clinical status.~   "
199576|NCT00950417|"~     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located~     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical~     efficacy has been shown in adult with head and neck cancer. The phase I study assessed the~     safety, and efficacy of the combination of Nimotuzumab administered concomitantly with~     chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.~   "
199577|NCT00950404|"~     The bioavailability of the oral disintegrating tablet formulations given without water will~     be similar to an equivalent dose of the standard oral tablet given with water.~   "
199578|NCT00950391|"~     Tacrolimus (FK506) is an immunosuppressive medication that promotes organ allograft survival.~     It has also been shown to enhance nerve regeneration and muscle reinnervation in animals but~     these properties have not previously been studied in patients. Moreover, currently there is~     no method in clinical use to speed the rate of recovery after nerve injury. The objective of~     this study is to explore the ability of tacrolimus to benefit the treatment of patients with~     peripheral nerve injury. To minimize the morbidity of tacrolimus therapy, its phase-specific~     effects on nerve regeneration and muscle reinnervation will be defined in the murine model to~     permit further limitation of the duration of therapy. The investigators hypothesize that~     treatment with tacrolimus after autogenous peripheral nerve reconstruction will accelerate~     nerve regeneration, reduce the period of denervation and improve muscle reinnervation and~     recovery in patients with peripheral nerve injury.~      There are 2 specific aims:~        1. Determine the safety and efficacy of tacrolimus following reconstructive nerve surgery~          in a double-blind placebo-controlled randomized pilot clinical trial of patients with~          severe nerve injuries of the extremities;~        2. Correlate the quality of life outcome with assessment of functional recovery after~          surgical reconstruction of patients with severe peripheral nerve injuries of the~          extremities.~   "
199579|NCT00950378|"~     The purpose of this study is:~      -item one to use two new non-invasive technologies to evaluate scarring and swelling~     associated with chronic venous insufficiency.~      The study hypothesis:~      - item one non-invasive technologies can provide a tool for assessing risk of ulcer~     development based on the tissue edema and alteration.~   "
199583|NCT00950326|"~     The study design consists of a prospective randomised controlled three-armed clinical trial,~     which will be carried out at a specialist clinic for integrative medicine, to investigate the~     clinical effects of hydrotherapy on osteoarthritis of the knee or hip joint, in comparison~     with conventional physiotherapy.~   "
201859|NCT00920257|"~     This study is a first time in human, Phase I, open-label, dose-escalation study of the oral~     AKT inhibitor GSK2141795 in subjects with solid tumors or lymphomas.~   "
199585|NCT00950300|"~     In this open-label multicenter trial, participants with operable or locally advanced breast~     cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles~     of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide)~     concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive~     a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of~     treatment. All cycles will be 21 days in length. After the end of study treatment,~     participants will be followed for safety and efficacy for up to 5 years or until disease~     recurrence, whichever is earlier.~   "
199586|NCT00950287|"~     Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with~     short term complications and alterations in neurodevelopment. Duration and amplitude of the~     bradycardias depend on the time delay between the beginning of the bradycardia and the~     intervention of the nurse.~      The purpose of the study is to test a new method set for early detection of bradycardia in~     preterm infants.~   "
199587|NCT00950274|"~     In spite of the fact that the post-myocardial infarction survival rate has improved with~     recent medical advances, reduced heart function attributed to irreversible loss of viable~     cardiomyocytes is still a major clinical problem.~      The aim of the current study is to determine whether intramyocardial injection of autologous~     CD133+ bone marrow stem cells yields a functional benefit in addition to coronary artery~     bypass graft (CABG) surgery in patients with chronic ischemic coronary artery disease.~   "
199588|NCT00950261|"~     The standard postoperative treatment for patients with cervical cancer who had high-risk~     factors is chemoradiation. Generally, weekly cisplatin or 5FU+cisplatin every 3 week have~     been used as chemotherapy regimens of chemoradiation. Based on their experience, the~     investigators hypothesized that tri-weekly cisplatin could be superior to weekly cisplatin.~     Therefore, the investigators are going to perform the efficacy study of postoperative,~     tri-weekly cisplatin chemoradiation for patients with cervical cancer.~   "
199589|NCT00950248|"~     Background:~        -  Multiple sclerosis (MS) is an inflammatory disorder of the central nervous system that~          progressively weakens and destroys the pathways of the nervous system. About 10 percent~          to 15 percent of patients develop primary-progressive MS (PP-MS), characterized by~          progressive accumulation of disability from the disease onset, without any marked~          improvements or relapses. There are currently no effective treatments for PP-MS.~        -  Idebenone is a manmade drug that is similar to a naturally occurring compound known as~          coenzyme Q10, a common dietary supplement. Research data suggest that idebenone may be~          able to limit demyelination and death of brain cells and thereby slow or halt the~          progression of neurological dysfunction such as that occurring in MS.~      Objectives:~      - To evaluate the safety and effectiveness of using idebenone to treat primary progressive~     MS.~      Eligibility:~      - Individuals between 18 and 65 years of age who have been diagnosed with primary progressive~     multiple sclerosis.~      Design:~        -  The study will last 3 years and will be divided into two parts: a 1-year pretreatment~          baseline and 2 years of treatment with either idebenone or a placebo.~        -  Pre-treatment study: approximately 5 clinic visits over 1 year.~        -  Visit 1: Comprehensive medical history and neurological examination, with brain scans~          and neurological tests.~        -  Visit 2: Magnetic resonance imaging (MRI) scan of the spine and lymphocytapheresis~          (withdrawal of white blood cells for testing).~        -  Visit 3: Lumbar puncture.~        -  Visit 4: Skin biopsy.~        -  Visit 5: Repeat MRI of the brain and spinal cord, as well as neurological tests; these~          tests will be scheduled over 2 days.~        -  After the five pretreatment visits, patients will receive a 6-month supply of study~          medication (either idebenone or a placebo) to take three times a day with food~        -  Patients will continue to have regular followup clinic visits with brain MRI scans,~          blood tests, and other evaluations of brain and nervous system function. Randomly~          selected participants will have additional MRI scans for further safety precautions.~   "
199590|NCT00950235|"~     This study will examine the safety and effectiveness of a dietary intervention in pregnant~     women. Women who are obese will be invited to participate. The control arm will receive~     routine prenatal care and one in-person nutritional and dietary counseling session to promote~     healthy eating during their pregnancy. The intervention arm will receive a more intensive~     dietary program that will include in-person counseling and group support sessions. The goal~     of the intervention will be weight maintenance (weight at 2 weeks after delivery should be~     within 3% of baseline weight) and avoidance of postpartum weight retention~   "
199591|NCT00950222|"~     The study is a prospective open trial conducted in 4 centers, and designed to determine if~     pharmacokinetic (PK) and pharmacodynamic (PD) parameters of imipenem, associated with~     amikacin as empirical therapy, impact microbiological and clinical outcome of patients with~     Gram negative bacilli (GNB) ventilator-associated pneumonia (VAP).~   "
199592|NCT00950209|"~     Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality~     at type 2 diabetes. The typical dyslipidemia that is associated with insulin resistance,~     which includes a postprandial elevation of triglyceride-rich lipoproteins (TRLs) with excess~     of intestinal triglyceride-rich-lipoprotein-apoB48 (TRL-apoB48), is felt to play an important~     role in the accelerated ASCD.~      The investigators' objectives in this study are to determine whether an acute elevation of~     plasma insulin, secondarily to plasma insulin infusion, modulates the production and the~     clearance rates of intestinal TRL-apoB48 in type 2 diabetic patients in the fed state and to~     determine if this is a direct effect of insulin or an indirect effect due to the decrease of~     plasma FFA or the decrease of plasma glucose.~   "
199593|NCT00950196|"~     Ataxia-Telangiectasia A-T is a neurodegenerative disorder of the cerebellum, manifesting with~     ataxia, as well as extrapyramidal features. Treatment of A-T is discouraging, since no~     treatment seems to change the course of disease, but improvement can be achieved by~     symptomatic treatment of the bothersome movement disorder . While various dopaminergic agents~     are occasionally used, reports of benefit are rather sparse and anecdotal. Amantadine, a well~     known drug used in influenza as well as movement disorder of Parkinson, has been proved to~     improve various other types of movement disorder as ataxia, chorea, dystonia, akinesia and~     attention span. The purpose of this study is to investigate weather amantadine sulphate~     improves ataxia and the movement disorder (bradykinesia, parkinsonism, dystonia, chorea), as~     well as the general well being in patients with A-T.~   "
199594|NCT00950183|"~     This study will compares differences in pain level, narcotic consumption, wound healing,~     patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho,~     Inc) versus those who use ice. This will be assessed postoperatively following the foot and~     ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament~     reconstruction (LAR).~   "
199595|NCT00950170|"~     Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe~     hemophilia A in patients who have not yet received treatment for their hemophilia. Study~     subjects will be males less than 6 years old who have not taken any clotting factor or other~     blood products before the study. The safety and effectiveness of ReFacto AF will be~     determined in this study by tests and procedures done at the doctor's office.~   "
199597|NCT00950144|"~     RATIONALE: Studying a patient's understanding of his or her illness, pain, symptoms, and~     quality-of-life may help the study of advanced cancer and may help patients live more~     comfortably.~      PURPOSE: This clinical trial is studying pain and symptom distress in patients with advanced~     colon cancer, rectal cancer, pancreatic cancer, or liver cancer.~   "
199598|NCT00950131|"~     The purpose of this study is to test whether a new drug warning decreases enthusiasm for new~     drugs.~   "
199599|NCT00950118|"~     The goal of this study is to identify genes that convey susceptibility to congenital~     diaphragmatic hernia in humans. The identification of such genes, and examination of their~     structure and function, will enable a delineation of molecular pathogenesis and, ultimately,~     prevention or treatment of congenital diaphragmatic hernia. There are many different possible~     modes of inheritance for congenital anomalies, including autosomal dominant, autosomal~     recessive, and multifactorial. Multi-factorial inheritance is responsible for many common~     medical disorders, including hypertension, myocardial infarction, diabetes and cancer. This~     type of inheritance pattern appears to involve environmental factors as well as a combination~     of genetic variations that together can predispose to or produce congenital anomalies, such~     as congenital diaphragmatic hernia.~      Our study is designed to establish a small, well-defined genetic resource consisting of 1)~     Nuclear families suitable for linkage analysis by parametric,non-parametric (e.g. sib pairs,~     TDT) and association techniques, 2) Individuals with congenital diaphragmatic hernia who can~     be directly screened for allelic variation in candidate genes, and 3) Individuals who can~     serve as controls (are unaffected by congenital diaphragmatic hernia). Neonates and their~     families will be collected from homogenous and heterogeneous populations. By characterizing~     diverse populations, it should be possible to increase the likelihood of demonstration of~     genetic variation in selected candidate genes that can then be used in association and~     linkage studies in individual subjects with congenital diaphragmatic hernia.~   "
199600|NCT00950105|"~     This study will be conducted in healthy male or female subjects using a double-blind,~     randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3~     healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3~     to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg,~     90 mg, and 270 mg.Safety will be evaluated throughout the study and include physical~     examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical~     laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and~     adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed~     repeatedly over the 24-hour observation period. Venous blood samples will be taken at~     specified intervals and tested for the presence of CPSI-2364.~   "
199601|NCT00950092|"~     This is a multi center, non-randomized, prospective, open label, clinical trial evaluating~     the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when~     used to treat patients with persistent and longstanding persistent AF during concomitant~     cardiac surgery.~   "
199602|NCT00950079|"~     The aim of this study is to determine whether sodium bicarbonate is superior to sodium~     chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary~     angiography or intervention.~   "
199603|NCT00950066|"~     The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood~     Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its~     individual constituents administered as monotherapy and placebo.~      The secondary objectives are:~        -  to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8~          weeks from baseline between each FDC, its individual constituents administered as~          monotherapy and placebo.~        -  to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each~          FDC, its individual constituents administered as monotherapy and placebo.~   "
199604|NCT00950053|"~     The purpose of this study is to determine whether Achilles tendon debridement and~     decompression augmented with flexor hallucis longus (FHL) tendon transfer results in improved~     clinical and functional outcome as measured by ankle plantar flexion strength and American~     Orthopedic Foot and Ankle Society (AOFAS) score compared to debridement and decompression~     alone in patients over 50 years of age with chronic insertional Achilles tendinosis.~      H0: There will be no difference in ankle plantar flexion strength measured using a handheld~     dynamometer between patients randomized to achilles tendon decompression and debridement~     alone (Group 1) and patients randomized to achilles tendon decompression and debridement~     augmented with FHL transfer (Group 2).~      HA: Patients randomized to achilles tendon decompression and debridement alone (Group 1) will~     have less ankle plantar flexion strength compared to patients randomized to achilles tendon~     decompression and debridement augmented with FHL transfer (Group 2).~   "
199605|NCT00950040|"~     This study is designed to test an intervention to reduce at-risk drinking among Type 2~     diabetic patients. At-risk drinking is associated with inferior diabetes treatment adherence~     and control. The investigators hypothesize that our brief alcohol intervention will result in~     a reduction in drinking and better diabetes treatment adherence and control. If successful,~     this intervention could help diabetics to gain better control of their diabetes and live~     healthier lives.~   "
199606|NCT00950027|"~     Head trauma and severe cerebral hemorrhage are major risk factors for development of~     ventilator-associated pneumonia. In a previous open labelled, single center study the~     investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be~     an effective strategy to decrease the prevalence of ventilator-associated pneumonia in~     patients with head trauma. The present study aims to confirm these results in a multicenter,~     double blind study including patients suffering from head trauma or cerebral hemorrhage.~   "
199607|NCT00950014|"~     The purpose of this study is to test comprehension of five numeric formats used to present~     data about treatment benefits and harms.~   "
199608|NCT00950001|"~     The goal of this clinical research study is to learn if stereotactic radiosurgery can help to~     reduce the risk of a brain tumor returning after surgery. The safety of this treatment will~     also be studied.~   "
199654|NCT00949403|"~     The purpose of this study is to evaluate how the liver receives and uses fats for energy.~     This will help the investigators further understand the physical and chemical processes~     responsible for Non-Alcoholic Fatty Liver Disease (NAFLD) in overweight females with or~     without NAFLD who are scheduled to undergo gastric bypass surgery.~   "
199609|NCT00949988|"~     This is an open-label phase I/II study that will investigate the combination of dasatinib and~     rituximab therapy in patients with relapsed/refractory CLL. In phase I, eligible subjects~     will take either 100 mg or 140 mg of dasatinib daily along with rituximab on day 1 of each~     cycle for 6 cycles. In phase II, eligible subjects will all receive the same dose of~     dasatinib, as established in the phase I portion, along with rituximab on day 1 of each cycle~     for 6 cycles.~      The investigators hypothesize that the combination of dasatinib and rituximab will~     demonstrate efficacy in the treatment of patients with relapsed/refractory CLL.~   "
199610|NCT00949975|"~     The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668~     at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on~     lung function and symptoms of COPD.~   "
199611|NCT00949962|"~     RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help~     focus thin beams of radiation directly on the tumor. Giving conformal external-beam radiation~     therapy in higher doses over a shorter period of time may kill more tumor cells and have~     fewer side effects. Androgens can cause the growth of prostate cancer cells. Hormone therapy,~     such as leuprolide acetate, may lessen the amount of androgens made by the body. It is not~     yet known whether radiation therapy is more effective when given together with or without~     hormone therapy in treating patients with prostate cancer who have undergone surgery.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared with radiation therapy given together with hormone therapy in treating~     patients who have undergone surgery for stage I, stage II, or stage III prostate cancer.~   "
199612|NCT00949949|"~     This randomized phase I trial is studying the side effects and best dose of everolimus,~     gemcitabine hydrochloride, and cisplatin in treating patients with unresectable solid tumors~     refractory to standard therapy. Drugs used in chemotherapy, such as everolimus, gemcitabine~     hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells.~   "
199613|NCT00949936|"~     The purpose of this European Union (EU) study to evaluate the safety and performance of the~     CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar~     intervertebral discs (L3 to S1) for patients requiring surgical intervention for total lumbar~     disc replacement for the treatment of debilitating, chronic low back pain.~   "
199614|NCT00949923|"~     Prognostic factors for breast cancer beyond stage at diagnosis and tumor characteristics have~     not been well studied. Of special interest are lifestyle factors that can be modified by~     women after diagnosis to increase disease-free survival. Green tea is rich in polyphenols~     consisting primarily of epicatechins, epigallocatechin, epicatechin gallate, and~     epigallocatechin gallate (EGCG). The investigators hypothesize that there will be a reduction~     in proliferation and/or an increase in apoptosis in association with short-term EGCG~     treatment.~   "
199615|NCT00949910|"~     This study will provide treatment with erlotinib to participants with advanced NSCLC who have~     received at least one course of standard chemotherapy or radiation therapy, or who are not~     medically suitable for either. Efficacy and safety will be monitored throughout the study.~   "
199616|NCT00949897|"~     The purpose of this study is to compare the clinical and radiographic outcomes of a~     randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a~     lateral column lengthening using an allograft bone wedge versus a titanium porous metal~     implant (Biofoam, Wright Medical).~      Null hypothesis: At six months postoperatively, there is no difference in the degree of~     correction as measured by the talonavicular coverage angle between patients randomized to~     allograft and Biofoam.~      Alternative hypothesis: At six months postoperatively, the degree of correction as measured~     by the talonavicular coverage angle will be less in patients randomized to allograft than the~     degree of correction in patients randomized to Biofoam.~   "
199617|NCT00949884|"~     This study will evaluate the efficacy and safety of the FDA approved blood pressure~     medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.~   "
199618|NCT00949871|"~     RATIONALE: A study that evaluates successful Los Angeles-based, peer-led African American~     breast cancer survivor support groups may help in developing a guide on how to organize and~     maintain breast cancer support groups.~      PURPOSE: This clinical trial is studying support groups for African-American breast cancer~     survivors.~   "
199619|NCT00949858|"~     The purpose of this study is to develop statistical and informatics tools for analyzing and~     visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients.~   "
199620|NCT00949845|"~     Recent research has demonstrated a relationship between depression and immune system~     activity, specifically proinflammatory cytokine activity. Although experimentally-induced~     immune activation leads to increases in depressed mood, the neural correlates associated with~     these changes have remained largely unexplored. Based on relationships between cytokine~     activity, depression, and heightened physical and social pain sensitivity, I propose to~     investigate the effect of proinflammatory cytokine activation on the neural correlates of~     socially painful experience that may contribute to depression. Our previous work has shown~     that the dorsal anterior cingulate cortex (dACC), typically associated with physical pain~     distress, also plays a role in the distressing feelings associated with social rejection or~     social loss. Moreover, recent pilot data has revealed that individuals with elevated levels~     of baseline proinflammatory cytokines report feeling more distressed and show more dACC~     activity during social rejection. To investigate the causal role that cytokines may play in~     the heightened social pain sensitivity that can contribute to depression, participants will~     be randomly assigned to receive either endotoxin (which increases proinflammatory cytokine~     activity) or placebo. Subsequently, participants will complete a neuroimaging study in which~     they will be rejected during an online ball-tossing game. We hypothesize that individuals~     exposed to endotoxin will report more social distress and depression following rejection and~     will show more dACC reactivity during rejection. The proposed study is the first to~     investigate the effect of systemic inflammation on neural reactivity related to social and~     affective processes that may increase the risk of depression.~   "
199678|NCT00949091|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple ascending-doses of TAK-875 in subjects with type 2 diabetes~     mellitus.~   "
199621|NCT00949832|"~     The purpose of this study is:~        1. To compare the response of rickets to calcium with and without vitamin D.~        2. To assess whether vitamin D increases calcium absorption in calcium deficiency rickets.~        3. To compare the response of children with and without rickets to orally administered~          vitamin D3 and vitamin D2~        4. To identify mutations that influence calcium and vitamin D metabolism among families of~          children with rickets in Nigeria and Bangladesh.~        5. To assess the functional status of the 25-hydroxylase enzyme in families possessing a~          25-hydroxylase mutation.~   "
199622|NCT00949819|"~     Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with~     low-risk, localized lesions, with curative treatment of those whose tumors show substantial~     progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative~     treatment of men with progressive prostate cancer.~   "
199623|NCT00949806|"~     Restless Legs Syndrome (RLS) is a common sensori-motor disorder that causes sensory~     discomfort and motor restlessness, most often in the legs, which improves with movement.~     Although medications are available to treat the disorder, many people either experience side~     effects that prevent them from continuing on the medication or do not sufficiently respond to~     current RLS medications. Recently, botulinum toxin type A (BNT) has been reported to relief~     RLS in patients with severe symptoms but this was not confirmed by other anecdotal reports.~     The investigators propose to test the efficacy of BNT on RLS symptoms by designing a more~     controlled study. Ultimately, this may lead to extend the therapeutic arsenal of this~     disorder.~   "
199624|NCT00949793|"~     The purpose of the study is to test the feasibility of obtaining interpretable in vivo~     endomicroscopy images which can be compared with traditional histopathology.~      Hypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide~     in vivo histology that enables differentiation of tumour tissue from normal adjacent brain~     tissue.~   "
199625|NCT00949780|"~     Chloral Hydrate (CH) is a well known drug for sedative and hypnotic purposes used in~     pediatric and dental procedures owing to the low depressive effect it has over respiratory~     and cardiac systems. Despite that, the literature reports cases of heart arrhythmia and~     sudden death in children, especially when using high doses, probably due to accumulation of~     serum trichloroethanol, an intermediate metabolite resulting from the liver metabolism of the~     drug. A possible carcinogenic action observed in guinea pigs has also been reported, even~     though it has not been confirmed in human beings.~      Among the least severe complications there are paradoxical agitation, nausea, vomiting and~     excessive sleepiness.~      CH is the drug of choice to sedate children undergoing Auditory Brainstem Response test~     (ABR), in which any movement or muscle contraction may generate artifacts that interfere in~     the analysis.~      Profound sleep that lasts on average one hour is rapidly induced depending on the used dose,~     causing no residual sleepiness after this period; however, there is consensus in the~     literature about the best dose, which may range from 40 to 100 mg/kg.~      Objective:~      To assess the efficacy of CH as a sedative agent in performing ABR in children and to~     systematize its use.~   "
199626|NCT00949767|"~     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics~     and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.~   "
199627|NCT00949754|"~     The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation~     of osteoarthritis of the knee.~   "
199628|NCT00949741|"~     The purpose of this study is to define if flow cytometry has more sensitivity for detecting~     neoplastic cells in cerebrospinal fluid versus conventional cytology.~   "
199629|NCT00949728|"~     To evaluate the recurrence and postoperative complications rates after conjunctival autograft~     surgery using fibrin adhesive for primary pterygium~   "
199630|NCT00949715|"~     The purpose of the Optimize RV Follow-Up study is to determine the long-term effect of~     selective site pacing. Selective site pacing refers to which area of the right ventricle the~     lead is placed. The goal of selective site pacing is to improve how the heart contracts when~     paced.~   "
199631|NCT00949702|"~     This open-label single arm study will assess the efficacy, safety and tolerability of~     Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive~     oral Vemurafenib [RG7204; PLEXXIKON: PLX4032] at a dose of 960 mg b.i.d. continuously until~     disease progression or withdrawal from study and will be assessed at regular intervals for~     tumour response and tolerability. Target sample size is <100 patients.~   "
199632|NCT00949689|"~     This study will develop and test a youth cognitive behavioral insomnia intervention to be~     employed as an adjunct to depression-focused cognitive behavioral treatments. The primary~     goal of the study is to improve the treatment and prevention of youth depression beyond that~     achieved with depression-focused pharmacotherapy and psychotherapies. The investigators'~     ultimate aim in developing this intervention is to enable a series of future outcome trials~     focused on improving unipolar depression outcomes in youth with comorbid insomnia, by~     addressing sleep dysfunction. The study will be recruiting from Kaiser Health Plan members in~     the Portland,Oregon metropolitan area and participants from the Bay Area region of~     California.~   "
199633|NCT00949676|"~     The purpose of this study is to determine whether heart rate variability-like parameters are~     related to changes in the disease status of a subject that suffers from a disease that~     decreases the pumping function of the heart.~   "
199634|NCT00949663|"~     An intestinal hormone called Glucose-dependent Insulinotropic Polypeptide (GIP) is released~     into the blood immediately after ingestion of a meal and plays an important role in~     regulating blood sugar levels. However, GIP is not active in persons with type 2 diabetes~     mellitus (T2DM) which is also known as adult onset or non-insulin-dependent diabetes. This~     study is being conducted to determine whether a hormone called xenin-25 can restore the~     activity of GIP in persons with T2DM.~   "
199635|NCT00949650|"~     This randomised, open label phase III trial will be performed in patients with adenocarcinoma~     of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation.~     The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A,~     with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of~     patients.~   "
199636|NCT00949637|"~     The purpose of the study was to evaluate the effectiveness of an intervention designed to~     prevent obesity by improving the environmental characteristics of Girl Scouts troop meetings.~   "
199637|NCT00949624|"~     A5301005 is a phase 1 study in patients with solid tumors which is testing the safety and~     tolerability of adding targeted agents to a standard chemotherapy. CP-868,596 is a~     platelet-derived growth factor receptor inhibitor (PDGFR) and AG-13736 is a vascular~     endothelial growth factor receptor inhibitor (VEGFR). This study will test the use of~     docetaxel (the standard chemotherapy) with either CP-868,596 or the combination of CP-868,596~     and AG-13736.~   "
199638|NCT00949611|"~     Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk.~     Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis~     treatment by providing an absolute fracture risk. FRAX combined with a decision aid may~     promote a shared decision making approach with patients, allowing the clinician and patient~     to weigh potential fracture risk (without treatment), versus risk reduction with medication~     (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:~        -  FRAX~        -  FRAX + decision aid~        -  Usual care (no decision aid and no FRAX given to clinician)~   "
199639|NCT00949598|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may~     fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known~     whether letrozole or tamoxifen citrate is more effective when given before surgery in~     treating older women with breast cancer.~      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works~     compared with tamoxifen citrate in treating older postmenopausal women undergoing surgery for~     breast cancer.~   "
199640|NCT00949585|"~     Chronic kidney disease is associated with high blood pressure, heart disease, and strokes.~     Potassium lowers blood pressure and may help prevent heart disease and strokes in the general~     population, but has not been well-studied in people with kidney disease. This study will look~     at the benefits and safety of two levels of potassium intake in patients with kidney disease.~     We expect that a higher level of potassium intake safely lowers blood pressure compared to a~     lower level of potassium intake. We hope that this and other research projects will help us~     to learn more so that guidelines can be created for potassium intake in patients with chronic~     kidney disease~   "
199641|NCT00949572|"~     This study is a preliminary investigation of immune responses, in the blood and in cervical &~     vaginal secretions, to proteins (antigens) taken up across the undersurface of the tongue.~   "
199642|NCT00949559|"~     This study is being done to:~        -  Test the safety of EP-100 and see what effect (good and bad) it has on the patient and~          their cancer;~        -  Find the highest dose of EP-100 that can be given without causing bad side effects;~        -  Examine how much EP-100 is in the blood at certain times after it is given and how~          quickly the body gets rid of it;~        -  Observe whether there is any effect of EP-100 on the size and activity of cancer in the~          patient's body.~   "
199643|NCT00949546|"~     Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality~     of life and allow healing of HS.~   "
199644|NCT00949533|"~     This open-label randomized 2 arm study will determine the emergence of viral resistance in~     participants with seasonal influenza A infection treated with oseltamivir. Eligible~     participants less than or equal to (</=) 5 years of age will be randomized to receive~     oseltamivir at either standard dose (30-75 milligrams [mg] orally twice daily [bid]) or~     double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (>) 100.~   "
199645|NCT00949520|"~     The goal of this study is to evaluate the ability of MDCT under stress to assess myocardial~     ischemia. There is some preliminary data in the literature showing the ability of MDCT under~     stress to bring relevant information about myocardial ischemia. Stress MDCT will have several~     advantages over single photon emission computed tomography (SPECT) imaging namely: shorter~     acquisition time, lower irradiation dose, lower cost. The feasibility of such experiment is~     still debated and need to be address in a clinical study.~   "
199646|NCT00949507|"~     Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing~     MRI in general anesthesia.~   "
199647|NCT00949494|"~     Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative used to treat knee~     osteoarthritis (OA). Animal studies have shown that Synvisc can have favorable effects on~     cartilage when injected into joints. This study attempts to evaluate the effects of Synvisc~     when injected into knees of patients with knee OA by means of a specialized MRI technology~     (dGEMRIC).~   "
199648|NCT00949481|"~     The rationale for the study stems from the goal of reducing the very high unmet need for~     family planning among women in their first year postpartum. It is understood that the reason~     this need is so high in general is because postpartum women do not always demand family~     planning services, and family planning providers do not always supply services to~     postpartum (amenorrheic) women who do demand them. To address these supply and demand~     problems, corresponding supply and demand solutions will be tested.~        1. Demand Generating Strategy—Integrate into Immunization Services Following birth, return~          to fertility among postpartum women is dependent on many factors. These include time~          since last birth, breastfeeding intensity, and menstrual status. However, when and how~          fertility returns is often misunderstood by women. For instance, many women think that~          they can not get pregnant before their menses return, or that as long as they are~          breastfeeding they are protected from pregnancy. Educating women about their return to~          fertility following giving birth, and reminding women about the importance of birth~          spacing for their health and the health of their children is the focus of the~          demand-generating strategy.~           To reach postpartum women with these messages a demand generating activity at~          immunization clinics will be conducted, as immunization services are well attended.~          Based on the recommended immunization schedules for infants, women will make several~          visits to these clinics throughout the course of their first year postpartum, which~          provides an ideal opportunity to hit them with family planning messages more than~          once.~           To aid providers of immunization services in their delivery of family planning messages,~          a simple job aid was developed. The job aid takes providers through a series of 3~          questions that will allow the provider to determine a mother's immediate risk for~          pregnancy (based on LAM criteria). If a woman is currently at risk for pregnancy, it~          prompts the provider to give a healthy timing and spacing message and to make a referral~          to the family planning clinic. If a woman is not currently at risk for pregnancy, the~          job aid helps the provider instruct the mother about when her risk for pregnancy will~          change, and therefore when she will need to seek family planning services to achieve~          proper birth spacing (should this be desirable to the mother).~           Also, in the family planning (FP) clinics that are located in the same facility as the~          immunization clinic, providers will be given the pregnancy checklist. This job-aid has~          already been researched (refer to citations). The purpose of providing it is to make~          sure that when women are referred to FP clinics by immunization providers, FP providers~          will supply them with a method. As a consequence, it hoped that by the time women are~          9-12 months postpartum, there will be an increase in uptake of non-condom family~          planning methods.~        2. Supply Solution—Diversify Tools Available to Rule-Out Pregnancy The supply strategy~          focuses on giving providers the tools to give contraceptive methods to women who are~          amenorrheic. As recommended by the WHO, it is standard practice for FP providers to rule~          out the possibility of pregnancy before providing many types of methods to their~          clients. The presence of menses is often used to make this determination. However,~          return of menses can be delayed for many months in the postpartum period, limiting a~          provider's ability to supply postpartum women with contraceptive methods. To overcome~          this challenge, the Pregnancy Checklist was developed. It is a job-aid designed to rule~          out pregnancy based on client responses to questions concerning her recent sexual and~          reproductive history. Urine pregnancy testing is another viable option for ruling out~          pregnancy in non-menstruating FP clients, especially in situations where providers feel~          they cannot trust women to answer questions honestly. Thus, family planning clinics will~          be provided with free pregnancy test strips, and the change in same day uptake of FP~          methods will be measured.~      Hypotheses~        1. Providing family planning messages to women attending immunization clinics with their~          child will cause them to seek family planning services in a greater proportion at 9-12~          postpartum.~        2. The availability of free pregnancy testing will increase same day method provision for~          new and restarting family planning clients.~   "
199649|NCT00949468|"~     The purpose of this study is to identify the predisposing factors, epidemiological features~     and clinical and microbiological diagnosis of infectious keratitis in two public referral~     centers of ophthalmology in a countryside city of Brazil.~   "
199650|NCT00949455|"~     RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. It is not yet known whether lapatinib ditosylate is more~     effective than a placebo in killing tumor cells.~      PURPOSE: This randomized phase II/III trial is studying how well lapatinib ditosylate works~     compared to a placebo in treating patients with stage IV bladder cancer.~   "
199651|NCT00949442|"~     Primary Objective:~      To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin~     Hagedornon) the change in HbA1c from baseline to the end of the treatment period.~      Secondary Objective:~      To compare between treatment groups:~        -  Plasma glucose (fasting, nocturnal) over time,~        -  Changes from baseline in HbA1c over time,~        -  Percentage of patients who reach the target of HbA1c <7 and <6.5,~        -  Use of prandial insulin as rescue medication at month 6,~        -  Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and~          severe),~        -  Daily dose of insulin,~        -  Change in body weight from baseline,~        -  Evolution of 8-point plasma-glucose (PG) profiles,~        -  Overall safety,~        -  Patient reported outcomes (treatment satisfaction).~   "
199652|NCT00949429|"~     The purpose of this study is to determine the incidence and risk factors of moderate to~     severe pain after cardiac surgery, and compare the preoperative pain expectation and~     postoperative pain experience in the same patient.~   "
199653|NCT00949416|"~     Objective: Recruit 3 cohorts with 1000-1200 subjects each: people with normal glucose~     metabolism, impaired glucose regulation (IGR), and with Type 2 diabetes. To study the risk~     factors in development of type 2 diabetes.~   "
251266|NCT00263055|"~     Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian~     patients~   "
199655|NCT00949390|"~     Primary Objective:~      · The primary objective is to estimate the prevalence of use of complementary and alternative~     medicine (CAM) in patients with advanced malignancies who are seen in the Phase I clinic at~     MD Anderson Cancer Center (MDACC).~      Secondary Objective:~      · Examine the association between prevalence of CAM use and demographic and socioeconomic~     characteristics (age, gender, race, income, and education level), participation in a phase I~     clinical trial, disease characteristics (diagnosis), patients' perceptions about their~     prognosis, physicians' information and permission for patients' CAM use, decision-making, and~     types of CAM used by patients.~   "
199656|NCT00949377|"~     The investigators want to prove that people WITHOUT advanced cancer who are taking opioid~     medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since~     the FDA has only approved MNTX for advanced cancer patients, the investigators' research is~     investigating how MNTX can work for NON-cancer patients. This research is being conducted to~     prove that MNTX can work for non-cancer patients with opioid related constipation.~   "
199657|NCT00949364|"~     This is a phase II, multi-center study of pomalidomide in adult patients with PMF, SMF, and~     unclassifiable MPN showing at least grade 1 bone marrow fibrosis and requiring therapy. All~     patients will receive per oral pomalidomide on a daily basis.~      First cohort (Before Amendment No. 1 ID 1-41):~      Treatment starts with a phase of pomalidomide therapy with 2 mg per day. Individual dose~     reduction as outlined in the safety section is allowed. If no response was achieved (no~     complete remission (CR), partial response (PR), clinical improvement (CI) and no progressive~     disease according to the IWG-MRT criteria) after 3 months, prednisolone is added in a~     starting dose of 30 mg per day. In the absence of progressive disease, at least 6 months of~     treatment with pomalidomide is intended. In patients without disease progression after 6~     months and those with response to treatment are intended to receive pomalidomide for at least~     12 months. Additional antiproliferative treatment with hydroxyurea for leukocytosis (>20 x~     109/l) and/or thrombocytosis (>750 x 109/l) and/or symptomatic splenomegaly in a starting~     dose of 2g/day with individual dose adjustment is allowed.~      Second cohort (After Amendment No. 1 ID > 41):~      To evaluate the relative impact of prednisolone to the objective response rate, a~     randomization has been integrated into the study concept. The addition of prednisolone is~     up-front randomized for the start of prednisolone either after 3 or 6 cycles of treatment~     with pomalidomide as single agent if no response occurred during this period. This results in~     the following treatment arms:~      Treatment Arm A) Pomalidomide 0.5 mg per day + additional prednisolone at start of cycle 4~     (day 85), in case no response was achieved until end of cycle 3.~      Treatment Arm B) Pomalidomide 0.5 mg per day + additional prednisolone at start of cycle 7~     (day 169), if no response was achieved until end of cycle 6.~      Treatment for all patients starts with pomalidomide as single agent at a dose of 0.5mg per~     day. The addition of prednisolone will be initiated as randomized either at start of cycle 4~     or start of cycle 7 (starting dose 30 mg per day). In the absence of progressive disease, at~     least 12 cycles of treatment with pomalidomide are intended.~      Additional antiproliferative treatment with hydroxyurea for leukocytosis (>20 x 109/l) and/or~     thrombocytosis (>750 x 109/l) and/or symptomatic splenomegaly in a starting dose of 2g/day~     with individual dose adjustment is allowed.~   "
199658|NCT00949351|"~     Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin~     converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown~     renoprotection whether it was used alone or in combination. Aliskiren is a direct renin~     inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to~     date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic~     nephropathy patients remains to elucidate.~   "
199659|NCT00949338|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Having a full~     bladder may improve the effectiveness of radiation therapy to the bladder. It is not yet~     known which set of bladder-filling instructions is more effective in helping patients keep~     their bladder full during radiation therapy.~      PURPOSE: This randomized clinical trial is comparing two sets of bladder-filling instructions~     in treating patients with prostate cancer undergoing radiation therapy.~   "
199660|NCT00949325|"~     The purpose of this study is to identify a safe dosing regimen for the combination of Torisel~     and liposomal doxorubicin in patients with recurrent sarcoma. A secondary purpose of the~     study is to determine how effective this combination is for the treatment of recurrent~     sarcoma.~   "
199661|NCT00949312|"~     RATIONALE: Diagnostic procedures that look for micrometastases in lymph nodes removed during~     surgery for colon cancer may help doctors learn the extent of disease.~      PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer.~   "
199662|NCT00949299|"~     Recent reports showed that the opioid buprenorphine is a very potent sodium channel blocker.~     Buprenorphine not only exerts a strong antinociception, but also a long lasting~     antihyperalgesic effect. This antihyperalgesic effect is not observed for other clinically~     employed opioids but is common for local anaesthetics.~      The principal aim of the study is to compare the speed of onset and the time of recovery of~     motor blockage achieved by lidocaine and buprenorphine, respectively. The investigators~     hypothesize that the blocking capacity of buprenorphine is equal to the one of lidocaine.~   "
199663|NCT00949286|"~     The study is designed to determine the long term, post trial effects of the two interventions~     studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared~     with placebo and intensive gliclazide-MR based glucose control as compared to standard~     guideline based glucose control) in individuals with type 2 diabetes at high risk of~     cardiovascular events. The long term, post randomization effects of the two study~     interventions will be investigated separately as they were for the main trial. This study~     will clarify and quantify the long-term, post trial (often referred to as legacy) effects of~     these two interventions in a broader population of patients with type 2 diabetes from high~     and low to middle income countries, and in the setting of comprehensive cardiovascular risk~     factor treatment. With the ADVANCE trial infrastructure and surveillance system already in~     place, the implementation of extended follow-up will be feasible. The conclusions of this~     follow up study will have profound clinical implications for the care of patients with type 2~     diabetes around the world.~   "
199664|NCT00949273|"~     The purpose of this study is to determine whether cylindrical abdominoperineal resection is~     effective in the treatment of advanced very low rectal cancer~   "
199665|NCT00949260|"~     The purpose of this study is to determine whether a noninvasive method of measuring certain~     aspects of blood circulation (e.g., blood pressure, cardiac output) is an accurate and~     reliable method to detect changes in pregnant patients. Specifically,the investigators are~     interested in patients diagnosed with high blood pressure during their pregnancy, as compared~     with normal pregnant patients. A noninvasive, accurate method of taking these measurements in~     pregnant patients is not currently available.~   "
199679|NCT00949078|"~     The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can~     eliminate or reduce symptoms of peanut allergy.~   "
199680|NCT00949065|"~     The purpose of this study is to determine whether intravenous immunoglobulins are effective~     in the treatment of complex-regional pain syndrome.~   "
199751|NCT00948142|"~     The purpose of this study is to determine the safety and efficacy of CEM-102 compared to~     Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).~   "
199666|NCT00949247|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as trastuzumab and bevacizumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy~     together with monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: This clinical trial is studying how well giving docetaxel and carboplatin together~     with trastuzumab and bevacizumab works in treating patients with stage I, stage II, or stage~     III breast cancer and bone marrow micrometastases.~   "
199667|NCT00949234|"~     The purpose of this program is to evaluate an effort to provide a comprehensive package of~     HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent~     HIV infection after an exposure) can be a part. It will also include risk reduction~     information and testing for other sexually transmitted infections.~   "
199668|NCT00949221|"~     Glycemic control in children and adolescent with type 1 diabetes remains inadequate, exposing~     them to the risk of vascular complications in adulthood.~      One of the limiting factors is the daily number of self measurements of blood glucose~     required to optimize intensive insulin therapy.~      Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation.~     A randomized clinical study has shown its efficacy at short term (3 months). However, optimal~     clinical use of these devices requires rigorous assessment of their effectiveness on glycemic~     control, tolerance and acceptability in medium and long term.~      Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM~     (continuous or discontinuous) on glycemic control compared to conventional blood glucose~     self-monitoring (SMBG).~      Population: Children and adolescents with type 1 diabetes with inadequate glycemic control~     despite intensive insulin therapy.~   "
199669|NCT00949208|"~     The purpose of this study is to support the development of Given® Diagnostic System~     applications.~   "
199670|NCT00949195|"~     Background:~      The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in~     patients with COPD is unpredictable from lung function data. The non-invasive assessment of~     pulmonary hemodynamics during exercise and flow-mediated vasodilatation measurement may give~     useful data in the rehabilitation of COPD patients.~      Methods:~      Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine~     echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange~     detection. Serum hsCRP level is also determined in COPD patients. Endothel dysfunction is~     detected by flow mediated vasodilation measurement after arm strangulation with Doppler~     ultrasonography.~      Primary endpoint:~      The degree of pulmonary artery systolic pressure change during exercise?~      Secondary endpoint:~        1. The degree of right ventricular function change during exercise?~        2. Is endothel dysfunction manifested with pulmonary artery pressure rise?~        3. What is the correlation between the systemic inflammatory marker hsCRP and the degree of~          pulmonary artery pressure rise?~   "
199671|NCT00949182|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as doxorubicin hydrochloride and mitomycin C, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and~     blocking blood flow to the tumor. Giving sorafenib tosylate before and after~     chemoembolization may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib~     tosylate before and after hepatic arterial chemoembolization with doxorubicin hydrochloride~     and mitomycin C works in treating patients with localized liver cancer that cannot be removed~     by surgery.~   "
199672|NCT00949169|"~     The aim of this study was to investigate whether carotid IMT can predict the presence of more~     advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by~     MDCT and whether MDCT could be useful next step for more aggressive treatment modality in~     Korean type 2 diabetic patients.~   "
199673|NCT00949156|"~     With the preliminary anatomical and histological study, the membranous structures of the~     sellar region was considered to be closely related with the growth pattern of~     Craniopharyngiomas(CP). By combined considering of the tumor-membrane relationship, this~     project was trying to classify the CP through retrospectively summarizing the pre- and~     postoperative imaging (MRI and CT), the intrasurgical findings, and the endocrine data of 198~     CPs with primary surgery in our hospital (since 1997 until now). As a result, a distinct and~     systematic CP classification was proposed. The possible originate site, surgical skills and~     postoperative treatment of all the subtype tumors were discussed and analyzed to provide a~     normalized surgical treatment for this kind of tumor. Then in the prospective cohort, the~     anticipated 100 CP patients will accept the normalized surgical treatment. And by the long~     term follow up, the postsurgical quantity of life (QOL) of patients was evaluated with aspect~     in cognition, circadian rhythm, endocrine, Water-Electrolyte and body weight, et al. By~     comparing with the long-term results of the retrospective cohort, the totally follow up data~     was statistically analyzed to assess the rationality of this standard treatment of CP.~   "
199674|NCT00949143|"~     The aim of this study is to investigate the effects of altering the wheelchair set-up on~     mobility and safety by changing the rear-axle position on a manual wheelchair.~   "
199675|NCT00949130|"~     The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs.~     established treatment of acute bacterial infection in adults.~   "
199676|NCT00949117|"~     RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss~     caused by cancer or cancer treatment. It is not yet known whether cyproheptadine~     hydrochloride is more effective with or without nutritional supplementation in improving~     weight and quality of life of young patients with weight loss caused by cancer or cancer~     treatment.~      PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how~     well it works when given together with or without nutritional supplementation in treating~     young patients with weight loss caused by cancer or cancer treatment.~   "
199677|NCT00949104|"~     RESEARCH HYPOTHESIS Orally administered sucrose 2 minutes prior to the procedure of OGT~     insertion reduces pain associated with the procedure.~      AIMS AND OBJECTIVES:~      To study the effect of 24% oral sucrose on decreasing the painful response to orogastric tube~     insertion .~   "
199682|NCT00949039|"~     Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis~     perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).~      Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.~      The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated~     pelvic perfusion.~   "
199683|NCT00949026|"~     The primary purpose of this study is to determine if it is effective to take samples of fluid~     from the patient's brain tumor with a microdialysis catheter for Torisel measurement. The~     investigators are also doing it to learn if it is safe to do so. The investigators will use~     these samples to measure how much Torisel reaches the patient's brain tumor. The use of the~     microdialysis catheter to collect brain fluid is an FDA approved method. This catheter is~     already being used in patients who have sustained severe brain trauma from head injuries. The~     catheter itself is smaller in size than the standard needle that will be used to take the~     patient's biopsy. To obtain additional information Torisel will also be measured at the same~     time in the patient's cerebral spinal fluid by taking it from a catheter placed in the~     patient's cerebral spinal fluid producing spaces in their brain and in their blood from a~     catheter in one of their vessels.~   "
199684|NCT00949013|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients enrolled on clinical trial SWOG-9313~     will respond to doxorubicin and cyclophosphamide.~      PURPOSE: This laboratory study is looking at tumor tissue samples from women with early-stage~     breast cancer enrolled on clinical trial SWOG-9313.~   "
199685|NCT00949000|"~     The objective of the study is to collect information on the naturally occurring variations in~     ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel~     Implantable Cardioverter Defibrillators (ICD).~   "
199686|NCT00948987|"~     The purpose of this research is to study why some people do not respond to the benefits of~     aspirin therapy. The benefit of aspirin is cardioprotection, or decreasing the risk of heart~     attack and/or stroke. Aspirin works by disabling the platelets, part of the blood cells used~     in clotting, from sticking together and forming blood clots, thus protecting the heart. It~     has been observed that failure to respond to aspirin therapy occurs in about 10% of the~     general population and that despite taking aspirin everyday, this group of non- responders is~     not getting protection for their heart. The investigators would like to determine why and how~     this happens.~   "
199687|NCT00948974|"~     The purpose of this study is to compare the efficacy of two variants of cognitive behavioral~     therapy (CBT) (cognitive therapy (CT) and acceptance and commitment therapy (ACT)), for the~     treatment of generalized social anxiety disorder.~   "
199688|NCT00948961|"~     The main purpose of this study is to examine the safety and tolerability of CDX-1401 when~     given in combination with an immune stimulant (resiquimod) to patients with advanced cancers~     that are known to express the NY-ESO-1 protein.~   "
199689|NCT00948948|"~     Mentor is undertaking a five-year prospective clinical study designed to collect safety data~     associated with the implantation of its gel-filled mammary prostheses. This study is an~     adjunct study, which will encompass clinical reviews of reconstructive cases in all~     patients who meet clinical and regulatory criteria for breast reconstruction with gel-filled~     mammary prostheses. This adjunct study will be accomplished under a limited clinical~     protocol in which specific parameters will be required but with controls somewhat less~     stringent than those normally required in Investigational Device Exemption (IDE) Trials.~   "
199690|NCT00948935|"~     This study evaluates the combination chemotherapy with gemcitabine, irinotecan and~     panitumumab in patients with advanced biliary cancer.~   "
199691|NCT00948922|"~     The purpose of this study is to evaluate the effectiveness of Bortezomib when added to~     standard chemotherapy medicine(s) for treatment of Multiple Myeloma.~   "
199692|NCT00948909|"~     This is a efficacy and safety study evaluating new treatment for subjects with mild to~     moderate Alzheimer's Disease.~   "
199693|NCT00948896|"~     Young African children living in high transmission areas suffer the greatest burden of~     malaria. In most African countries, such as Uganda, the only current preventive measure~     against malaria in high transmission settings is the use of insecticide treated bednets~     (ITNs). Preliminary data show that even in the setting of ITN use, young children living in a~     high transmission setting suffer almost 4 episodes of clinical malaria per year, highlighting~     the need for new preventive strategies. Chemopreventive strategies offer a potential means of~     reducing the burden of malaria among young children living in a high transmission setting.~     This study will compare the efficacy and safety of 3 promising chemopreventive strategies~     (monthly dihydroartemisinin-piperaquine, monthly sulfadoxine-pyrimethamine, daily~     trimethoprim-sulfamethoxazole) with the current standard of no chemoprevention and will be~     conducted in two distinct patient populations: 1) HIV-unexposed children (HIV-uninfected~     children born to HIV-uninfected mothers) and 2) HIV-exposed children (HIV-uninfected children~     born to HIV-infected mothers). The intervention will begin in HIV-unexposed children when~     they reach 6 months of age, the time at which the incidence of malaria begins to increase,~     and will be continued until the children reach 24 months of age, which prior data suggest is~     when the incidence of malaria begins to decline due to the development of semi-immunity. In~     addition, study participants will be followed for one additional year following~     chemopreventive therapy to examine for rebound in the incidence of malaria following our~     intervention. HIV-exposed children will begin the intervention when they have completed~     breastfeeding and have been confirmed to remain HIV-uninfected. The intervention will~     continue until study participants reach 24 months of age and then the study participants will~     be followed for an additional year to examine for rebound in the incidence of malaria. It is~     anticipated that the results of this study will provide valuable comparative data on the~     effect of different chemopreventive strategies on malaria incidence in two distinct patient~     populations at high risk for malaria. In addition it is anticipated the results of this study~     will provide insight into the development of naturally acquired antimalarial immunity in the~     setting of chemopreventive therapy that will differ in terms of the drug regimens, the age at~     which the intervention is started, and the HIV status of the mothers.~   "
199730|NCT00948415|"~     Obesity is a major health problem that has reached epidemic levels. Efforts are needed to~     develop cost-effective public health approaches for weight loss and maintenance. One such~     approach is to develop team-based programs that may motivate people to lose weight and/or~     increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI).~     The current trial is investigating whether adding both a behavioral intervention delivered~     online PLUS automated feedback to self-monitoring would enhance the outcomes of SURI~     participants.~   "
199734|NCT00948363|"~     The purpose of this study is to determine whether the intake of kiwi fruits will reduce~     systolic and diastolic blood pressure compared to intake of apples. The investigators~     hypothesize that the increased intake lutein or other components in the kiwi fruit will~     enhance nitric oxide bioavailability and lead to vascular relaxation.~   "
199735|NCT00948350|"~     This is a prospective, comparative, randomized, monocentric, clinical open study, to compare~     two anesthesia techniques (translaryngeal injection vs. spray as you go) in patients with~     cervical instability with regard to technical modalities and quality of fiberoptic awake~     intubation.~   "
199694|NCT00948883|"~     About 1500 solid organs transplants are performed each year in the Paris agglomeration.~      Cancer risk in the transplanted is about three times higher than in a population of the same~     age without any organ transplant. Thus cancer is an important problem for organ transplant.~      These cancers can be related to many factors :~        -  Post-transplant cancers are due in part to the non specific immunosuppression, which~          leads to oncogenic viruses replication, and then produces virus inducted cancers (as~          lymphoma due to EBV virus).~        -  Post-transplant cancers can also be due to the carcinogenic factors of the~          immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance~          of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear~          to have anti-cancer properties.~        -  Post-transplant cancers which are not virus-inducted can be relied to genetic factors of~          the transplanted patient and/or the transplant donor.~      There are 4 axes in this study :~        -  Axis 1 : Epidemiological, clinical and biological study of the incident cancers in~          transplanted patients.~        -  Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the~          transplanted patient (determine their characteristics when a cancer appears).~        -  Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the~          cancer is caused by the donor or the recipient). Creation of a biobank.~        -  Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of~          patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).~   "
199695|NCT00948870|"~     The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription~     Shugan decoction on irritable bowel syndrome（diarrhea type）.~   "
199696|NCT00948857|"~     The experimental focus of this project is on the interaction of DHEA treatment on pregnancy~     in women with open tubes, fertile male partners and evidence of premature ovarian failure.~   "
199697|NCT00948844|"~     The aim of this study is to develop an algorithm to automatically detect falls and near~     falls, in the elderly and in Parkinson's Disease patients. Subjects will arrive at the~     investigators' gait laboratory for assessment. A sub-group of the subjects, will receive a~     monitoring device, to be worn at home for three days.~   "
199698|NCT00948831|"~     This study is being conducted to determine the percentage of patients with solid spinal~     fusions after being treated with Osteocel Plus in an ALIF procedure. Due to the unique~     processing conditions, Osteocel Plus retains a high concentration of stem cells in~     conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with~     Osteocel Plus will be comparable to published data for autograft. The Osteocel product family~     has already been used in approximately 15,000 cases worldwide.~   "
199699|NCT00948818|"~     The objective of this trial is to determine the efficacy and safety of linaclotide~     administered to patients with irritable bowel syndrome with constipation (IBS-C).~      The primary efficacy parameter is the percentage of patients in each treatment group that~     meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC)~     Responder.~   "
199700|NCT00948805|"~     This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh)~     agonist to prevent the rise of progesterone during controlled ovarian stimulation for in~     vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on~     the first day of menses.~   "
199701|NCT00948792|"~     To evaluate changes in platelet counts and hemodynamics between rapid and long platelet~     infusion groups.~   "
199702|NCT00948779|"~     The purpose of this study is to determine if a patient education in acute condition about the~     intake of oral solution antibiotic in children under 6 year-old are effective to improve the~     satisfaction about the therapeutic education, the knowledge about antibiotics among the~     patients' families and thereby decrease the misuses of antibiotics.~   "
199703|NCT00948766|"~     The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h~     transdermally (15 cm^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h~     transdermally (5 cm^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a~     24-week study. The extension study obtained additional safety and efficacy data, as well as~     provided the higher dose rivastigmine patch to all patients who completed the core study for~     an additional 24 weeks.~   "
199704|NCT00948753|"~     This study investigates the effectiveness and safety of Maraviroc (an oral medication given~     twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus~     Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell~     transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD~     prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day~     30 after stem-cell infusion.~   "
199705|NCT00948740|"~     The investigators hypothesize that a 3 month course of vitamin D supplementation to treat~     25(OH)D deficiency in stone formers with high levels of 24-hour urinary calcium will not~     increase urinary calcium excretion by greater than 10%.~   "
199706|NCT00948727|"~     The purpose of this trial is to assess whether an adaptation of cyclosporine (CsA) dose~     according to a longitudinal calcineurin (CN) activity monitoring would prevent the onset of~     graft-versus-host disease (GVHD).~   "
199731|NCT00948402|"~     Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS)~     physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein~     related to insulin sensitivity, is over-expressed in type 2 diabetic patients and in PCOS~     women, independently of obesity. The effectiveness of oral contraceptives pills (OCP) or~     metformin (MET) in PCOS management is still uncertain. Aim of this pilot clinical study was~     to compare the effects of OCPs or MET on the expression of PED/PEA-15 in association with~     insulin sensitivity in obese PCOS women. Outcome measures: PED/PEA-15, BMI, plasma glucose~     and insulin, 1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI,~     quantitative insulin sensitivity check index; ISI: whole-body insulin sensitivity index.~     Study design: twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were randomized~     according to insulin sensitivity to receive 30 µg ethinylestradiol plus 30 mg drospirenone 21~     day/month or MET 1250 mg three times daily for 6 months. Results: At baseline, age and BMI~     were not different in the two groups; PED/PEA-15 protein expression was higher in MET than in~     OCP group (p=0.011), along with higher 1/HOMA-IR (p=0.004), and lower QUICKI and ISI (p=0.003~     and p<0.001, respectively). After treatment, independently of body weight, only in MET group~     PED/PEA-15 decreased (p=0.004), along with insulin and 1/HOMA-IR (p<0.001), and QUICKI and~     ISI increased (p<0.001). Insulin sensitivity indexes improvement correlated significantly~     with PED/PEA-15 protein expression, but not with BMI. Conclusions: PED/PEA-15 protein~     over-expression in obese PCOS women with IR reduced after a six month treatment with MET,~     while remained unchanged in the OCP group. The reduction was independent of body weight, and~     correlated with insulin sensitivity indexes. This effect further supported MET as a more~     effective therapy than OCPs for obese PCOS women with IR, also when fertility is not~     required.~   "
199732|NCT00948389|"~     To determine whether dasatinib plus lomustine are effective for treatment of recurrent~     glioblastoma~   "
199707|NCT00948714|"~     Project Overview:~      Poor hypertension control has dire consequences for the African-American population who~     suffer greater death and disability from heart disease, stroke, and renal failure than~     whites. To reduce these health disparities it is critical to promote of a healthy lifestyle~     in regard to diet, exercise, adherence to medications, as well as other behaviors. However,~     physicians usually fail to address lifestyle behaviors in the context of the harried patient~     visit. Therefore, the investigators hypothesized that the investigators could reduce~     cardiovascular risk by providing additional support to persons with poorly controlled~     hypertension through phone calls from trained peer patients and visits to an office support~     staff member.~      Study Design:~      A single-blind, randomized, controlled trial in 280 African-American primary care patients~     aged 40-75 with poorly controlled hypertension (HTN). The intervention group receives a~     practice-based team intervention that combines peer coach with office staff (i.e., medical~     assistant or licensed practice nurse) visits to address lifestyle challenges. Both~     intervention and control groups receive informational materials and healthy soul food recipes~     from the American Heart Association. The 6 month intervention alternates monthly phone calls~     from peer coaches about lifestyle behavioral changes with office-based visits with the~     support staff member during which patients review and discuss low literacy slide shows about~     healthy behaviors as well as examine their personal cardiovascular risk profile.~   "
199708|NCT00948701|"~     Physical activity programs, when offered in research settings, have been shown to improve~     quality of life and reduce fatigue among breast cancer survivors. The investigators are~     training Reach to Recovery volunteers at the American Cancer Society (New England Division)~     to provide a 12-week telephone-based physical activity program (RTR Plus) for breast cancer~     survivors. The comparison group of survivors will receive Reach to Recovery services (RTR).~     Physical activity, fatigue and other outcomes will be examined among 108 breast cancer~     survivors at the start of the program, at 12 weeks and 24 weeks. If the physical activity~     program is found to be effective, there is a potential for dissemination among the 13,000~     Reach to Recovery volunteers across the U.S.~   "
199709|NCT00948688|"~     The durg vorinostat (Zolinza) is a type of drug called an histone deacetylase (HDAC)~     inhibitor. It inhibits a group of enzymes called histone deacetylases. These enzymes help~     cancer cells survive. By inhibiting these enzymes, vorinostat helps kill cancer cells. In~     this research study vorinostat will be given along with radiation therapy and the drug 5-FU.~     This is the first research study in which vorinostat will be given along with radiation~     therapy and 5-FU. The purpose of this research study is to find the highest dose of~     vorinostat that can be given safely along with radiation therapy and 5-FU. The investigators~     will also begin to get information about whether vorinostat combined with radiation and 5-FU~     may help to treat pancreatic cancer.~   "
199710|NCT00948675|"~     The purpose of this study is to compare the regimens of pemetrexed, carboplatin with~     pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance~     in participants with Stage IV nonsquamous non-small cell lung cancer.~   "
199711|NCT00948662|"~     This study will assess the safety and tolerability of ascending single oral doses of SAM-760~     in healthy young adult and healthy elderly subjects. The secondary objectives are to provide~     the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on~     the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and~     to evaluate the effects of concomitant administration of ketoconazole on the safety and the~     concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult~     subjects.~   "
199712|NCT00948649|"~     The goal of the proposed study is to validate an experimental paradigm to assess medication~     effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence~     and a programmed cigarette lapse.~   "
199713|NCT00948636|"~     The study tests the hypothesis that related hematopoietic stem cell donors are at a higher~     risk for acute medical and psychological toxicity associated with the donation process~     compared to adult unrelated hematopoietic stem cell donors.~      The study will also assess the hypothesis that young (<18 years) and older (>60 years)~     related donors are at increased risk for toxicity associated with donation compared to~     younger adult donors by describing the adverse events reported in these populations.~      An ancillary study of the psychological impact of donation on health-related quality of life~     (HRQoL) will enroll related donors and compare them to an age-matched normative cohort.~   "
199714|NCT00948623|"~     This randomized controlled trial will assess the effect of adding intensive physical activity~     counseling to an outpatient pulmonary rehabilitation program. Counseling including real-time~     feedback on daily activities from an activity monitor will be offered to improve~     participation in physical activities in daily life during and after an outpatient pulmonary~     rehabilitation program.~   "
199715|NCT00948610|"~     More than half of rheumatoid arthritis (RA) patients complain of sleep disturbance and this~     cardinal complaint is associated with fatigue, pain, and depressed mood in patient with~     chronic inflammatory disorder. Despite the frequency of this complaint, there is limited~     efforts to evaluate sleep or the abnormal increases in the expression of pro-inflammatory~     cytokines play a key role in the progression of RA, we hypothesize that the cytokine network~     is one physiological system that is associated with sleep disturbances in RA patients.~     Pro-inflammatory cytokines signal the central nervous system and are associated with~     increased symptoms of pain, fatigue, and depressed mood in rheumatic patients. The specific~     aims of the study are to examine the contribution of cytokines on sleep by administering a~     TNF antagonist vs. placebo to probe the action of pro-inflammatory cytokines on sleep in RA~     Patients. Examination of sleep and its consequences for pro-inflammatory cytokine activity~     within the framework of an observational and experimental research design will have~     implications for understanding the psycho-biological mechanisms that link sleep and the~     clinical manifestations of RA. Results from this study will guide the developments of~     interventions that target disordered sleep with potential effects on disability in RA.~   "
199733|NCT00948376|"~     The aim of the project is to prospectively analyze at a clinical and molecular level a series~     of 50 asphyxiating thoracic dysplasia (ATD) patients and 20 fetuses to further define the~     natural history of the disorder and to contribute to the identification of its molecular~     basis.~   "
199805|NCT00947440|"~     The purpose of this study is to assess the bioavailability, safety, tolerability and~     pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended~     in liquid.~   "
199716|NCT00948597|"~     The U.S. National Health and Nutrition Examination Survey of 1994 indicated that 59% of~     American men and 49% of women have body mass indexes (BMIs) over 25. Extreme obesity, defined~     as a BMI of 40 or more, was found in 2% of the men and 4% of the women~     [http://www.cdc.gov/nchs/nhanes.htm]. The newest survey in 2007 indicates an alarming~     increase in BMI; 63% of Americans are overweight, with 26% now in the obese category. With~     extreme obesity as high as 26-30% in adults, obesity percentages in children are also sharply~     on the rise. These alarming numbers pose a major clinical problem in terms of the safe and~     effective use of drugs in children.~      Obesity may alter the disposition and/or clearance of drugs in the body as well as the~     response, which should be considered when using anesthetics in these patients. Total~     intravenous anesthesia (TIVA) with propofol is widely used in children, adolescents and~     adults undergoing surgery, because of rapid onset of action, ease of titration and rapid~     offset of action. While extensive research on optimal propofol dosing has been performed in~     non-obese adults, including in critically ill mechanically ventilated adult patients by the~     investigators' collaborators, there is no evidence on required dosages in morbidly obese~     adult or pediatric patients of this highly lipophilic agent. As a consequence, serious~     problems do arise due to under- and overdosing, increasing the risk of inadequate effects and~     adverse events, respectively. Crucial additional information is needed on the~     pharmacokinetics of drugs used in morbidly obese children to improve safety and efficacy.~      This proposal will test a novel approach by identifying pharmacokinetic/pharmacodynamic~     (PK/PD) factors that are associated with response to therapy and adverse events. If~     successful, this study will provide proof of concept data for PK/PD model-based dosing~     strategy that can be implemented into daily clinical care to allow tailoring of dose to~     individual needs. Propofol is a versatile anesthetic agent which if dosed to individual needs~     based on a patient's characteristics and specific PK/PD parameters, will allow individualized~     dosing, thereby greatly reducing related toxicities. The prospective identification of~     predictive factors in these morbidly obese high-risk patients represents a new approach to an~     increasingly common clinical problem. The investigators expect that this study will generate~     the PK/PD data necessary to continue with a well powered prospective clinical trial.~   "
199717|NCT00948584|"~     The investigators designed the system in type 2 diabetic patients treated with long acting~     insulin to produce an automatic adjustment of insulin dose based on real time glucose level~     data and to provide to the patients the needed insulin dose by using a short message service~     (SMS) and apply to the clinical practice.~   "
199718|NCT00948571|"~     Perioperative airway resistance and lung function are evaluated perioperatively in patients,~     who undergo surgical procedures in different postures and with or without gas insufflation~     into the peritoneal cavity.~   "
199719|NCT00948558|"~     1. To compare the differences of citrate pharmacokinetics in healthy individuals and~          critically ill patients as well as the influential factors.~        2. To validate a pharmacokinetic model which has been established in a formal paper.~        3. To create a safe and effective RCA-CRRT protocol.~   "
199720|NCT00948545|"~     In the proposed study, the investigators will explore three specific aims. First, the~     investigators will examine cross-sectionally the association of obesity on sympathetic,~     parasympathetic, and sympathetic/ parasympathetic nerve fiber balance. In addition, the~     investigators will determine the relationship of the ANS and osteocalcin. Osteocalcin will be~     measured before and after a mixed meal tolerance test.~      In the second specific aim, the investigators will prospectively follow-up these individuals~     (n=30) following bariatric surgery. The effect of weight loss on measures of the ANS and~     osteocalcin will be examined 6 months following surgery with participants serving as their~     own control, pre- and post-surgical intervention.~      Thirdly, the investigators will address whether the effect of weight loss on the ANS and~     osteocalcin differ between those who had a history of diabetes at baseline versus those with~     no history of diabetes.~   "
199721|NCT00948532|"~     This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus~     in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two~     levels. These subjects will present with degenerative conditions in the lumbar spine that are~     amenable to surgical treatment and will be screened prior to study enrollment. Subjects will~     receive Osteocel Plus during their XLIF operation. Subjects will be followed for 24-months~     following surgery to determine the number of study subjects that are solidly fused at or~     before 24 months postoperatively, and to determine the mean time to fusion. This data will be~     compared to published and/or retrospective data for autograft, synthetic ceramics and Bone~     Morphogenetic Protein (BMP).~   "
199722|NCT00948519|"~     Chronic rhinosinusitis (CRS) is common disorder which affects up to 13% of the US population.~     CRS affects numerous Quality of Life (QOL) factors including smell, sleep and communication.~     The common treatment for medically noncompliant CRS is Functional Endoscopic Sinus Surgery~     (FESS).~      As the disease course is generally idle, prolonged medical treatment guidelines are for~     antibiotic treatment, prescribed accordingly following appropriately obtained nasal cultures,~     lasting weeks with or without additional topical or oral steroid treatment. While FESS~     success rate is a general notion, a failure rate of primary FESS is as high as 2-24%2, with a~     Cochrane review even suggesting that FESS though a safe procedure is of no benefit more than~     medical management.~      With that in mind as we address the failed FESS, new bacteria emerge. The new bacteria in CRS~     are Coagulase-negative staphylococci were the most common isolates (36%), followed by~     Staphylococcus aureus (25%), Streptococcus viridans (8.3%), Corynebacterium (4.6%), and~     anaerobes (6.4%).~      Patients not relieved by primary FESS demonstrate a significant rise in Pseudomonas and MRSA~     bacteria positive cultures. Moreover surgical success for patients with Staphylococcus aureus~     and Pseudomonas aeruginosa positive cultures is usually reduced.~      Bacterial killing, by usage of light-activated agents such as Indocyanine Green (ICG) with~     exposure to the specific wavelength, eventually produces bacterial killing. Mechanisms~     primarily involved are production of reactive oxygen species (i.e. singlet oxygen and free~     radicals) which can then kill bacteria. ICG by itself does not have any bacterial killing~     effect.~      Low level laser therapy (LLLT) was shown to be effective as a bactericidal by single and~     multiple wave exposures.~      The study purpose is to treat CRS with an alternative to antibiotics, thus sparing volunteers~     from prolonged antibiotics use and its possible side effects, not to mention the cost and~     growth of resistant bacteria. We believe that by combining ICG with light or even by light~     alone we can produce you a beneficial effect. Although this has been shown to kill bacteria~     in lab or animal studies it is still investigational for humans. The study will have two~     arms: ICG + laser and laser only arm. ICG will be applied locally in the nasal passage~     (internally) followed by laser activation with a power setting of 6W. The laser will be~     activated with a diffuser mode meaning light of a specific known wavelength will be delivered~     evenly in the nasal cavity and not as a beam. Laser only treatment plan will be the same only~     without ICG. Volunteers will be assigned to one of the groups randomly meaning you have a 50%~     chance of enrolling to each treatment group. Volunteers will not know to which group. Weekly~     visits with a total of three visits will follow. With each visit Volunteers will receive~     additional treatment as the initial treatment was and a nasal culture will be taken.~     Volunteers will have to fill a questionnaire with each visit.~   "
199723|NCT00948506|"~     This is a two-arm, single center placebo-controlled double-blind proof of concept study which~     will evaluate the safety and efficacy of topical cidofovir (both 1% and 3%)compared to~     placebo for the prevention of hair growth.~   "
199724|NCT00948493|"~     The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with~     serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory~     alternative therapy available for treatment of diabetes, and who are not eligible to~     participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is~     intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.~   "
199725|NCT00948480|"~     This protocol was conducted as a single institution trial at Hoag Cancer Center, Hoag~     Hospital, Newport Beach, California. It was a single-arm phase II trial in which patients~     with metastatic melanoma received subcutaneous (s.c.) injections of irradiated autologous~     tumor cells that had been established as short-term cell lines, in conjunction with their own~     dendritic cells (DC) and granulocyte macrophage colony-stimulating factor [GM-CSF]. Eligible~     patients had regionally recurrent and/or distant metastatic cancer.~   "
199726|NCT00948467|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and~     maximum tolerated dose of TAK-733 in patients with advanced, nonhematologic tumors. The~     expansion stage of the study will evaluate evidence of antitumor activity of TAK-733 in~     patients with advanced metastatic melanoma.~   "
199727|NCT00948454|"~     The current proposal, will elucidate the role of oxidant stress (OS) on arterial function as~     measured by flow mediated vasodilation. In addition, the investigators will address the~     hypothesis, that a pro-oxidant might have different degrees of effects on different~     biological targets, by performing quantitative assessment of the effects of OS on lipids,~     proteins and DNA.~   "
199728|NCT00948441|"~     This study is a double-blind crossover design to compare prophylaxis with ethanol lock~     therapy versus placebo lock therapy (heparin). The primary outcome measure will be the number~     of catheter related blood stream infections (CRBSI) in each time period.~   "
199729|NCT00948428|"~     At the end of the study, safety and efficacy outcome measures will be compared to determine~     a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently~     marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in~     comparison to the Vehicle cream.~   "
227241|NCT00583063|"~     Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with~     advanced solid tumors.~   "
199737|NCT00948324|"~     The purpose of this study is to investigate and evaluate the effects of different~     interventions (1.continuous subcutaneous insulin infusion,2.continuous subcutaneous insulin~     infusion combined with rosiglitazone 3.continuous subcutaneous insulin infusion combined with~     metformin,4.continuous subcutaneous insulin infusion combined with α- thioctic acid daily~     injections,) on glycemic control, B-cell function and the remission rate in newly-diagnosed~     type 2 diabetic patients.~   "
199738|NCT00948311|"~     The purpose of this study is to develop and validate a survey instrument to be used by~     persons with type 1 diabetes aged 12 and older to screen for an eating disorder.~   "
199739|NCT00948298|"~     Vitamin D is a natural nutrient. A little comes from our normal daily diet. Most of it comes~     from our skin after we have been in sunlight. If we have darker skin, we make less vitamin D.~     Vitamin D balances the calcium in our body. If our vitamin D levels get too low it can cause~     health problems. It may increase our chance of getting high blood pressure or diabetes.~     Another problem we may have if our vitamin D levels are low is that our blood vessels may not~     work normally. These are important health problems for anyone. Because African Americans have~     darker skin, they are more likely than most other racial/ethnic groups to have low vitamin D~     levels. This study will look at treating African Americans with low vitamin D levels.~      The goal of this study is to see how vitamin D helps blood vessels work. The investigators~     will do this study in African Americans who are overweight, have high blood pressure and have~     low vitamin D levels. The investigators will see if getting the vitamin D level to a normal~     value will improve how blood vessels work. The dose of vitamin D that will be given in this~     study is a high dose that is given to people with low vitamin D levels.~   "
199740|NCT00948285|"~     The purpose of this study is to determine if the use of magnetic resonance imaging (MRI) for~     breast cancer translates into better surgical outcomes. MRIs may help ensure that as little~     healthy tissue is removed as is possible and may help prevent the need for additional~     surgical procedures.~   "
199741|NCT00948272|"~     The purpose of this study is to generate data in human on immunogenicity and safety of~     Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.~      Primary Objective:~        -  To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab,~          in terms of seroconversion rate at Day 42 of the primary vaccination series.~      Secondary Objectives:~        -  To assess the clinical safety of VRVg after each vaccination when administered in a~          pre-exposure vaccination schedule with a booster at 12 months after the first~          vaccination in all subjects.~        -  To describe the immune response induced by VRVg 21 days after two vaccinations in a~          subset of randomized subjects and 14 days after the last vaccination of the primary~          vaccination series.~   "
199742|NCT00948259|"~     The purpose of this study is to evaluate if 4 escalating doses during 20 weeks of NP031112~     are safe and tolerated in patients with Alzheimer´s disease.~   "
199743|NCT00948246|"~     The purpose of this study is to collect additional safety, performance and effectiveness data~     of the Easyband gastric band medical device in the treatment of morbid obesity in 4 European~     countries where the device is a CE marked approved product.~   "
199744|NCT00948233|"~     The goal of this behavioral research study is to test a new multimedia anti-tobacco video~     game tailored to the U.S. Army. Researchers want to study how using the program affects~     tobacco use in soldiers, as compared to standard anti-tobacco programs.~   "
199745|NCT00948220|"~     One single study has suggested that bone mineral density (BMD) is reduced in patients with~     non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard~     interferon and ribavirin may further decrease BMD. The aim of this study is to systematically~     investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard~     therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.~   "
199746|NCT00948207|"~     The investigators will test whether narrative life review and web-based social networking for~     middle aged adults with advanced cancer will improve:~        1. existential well being (and reduce psychological distress)~        2. generativity and relationship quality, thereby mediating the intervention effects~      The investigators will also conduct exploratory process analyses of each participant's social~     network.~   "
199747|NCT00948194|"~     In this study, the researchers propose to investigate the efficacy of inhaled nitric oxide to~     prevent ischemia-reperfusion (I/R) hepatocyte injury in patients who receive extended donor~     criteria(EDC)liver grafts based on changes in proteomic and metabolomic markers following~     revascularization of the donor graft.~      In reviewing the literature, no uniform extended criteria donor classification exists. The~     characteristics most associated with liver graft failure appear to be cold ischemia time~     greater than 10 hours, warm ischemia time greater than 40 minutes, donor age > 55 years of~     age, donor hospitalization > 5 days, a donation after cardiac death (DCD) graft, and a split~     graft. The researchers will exclude warm ischemia time as this is impossible to predict prior~     to the transplantation. Any donor meeting at least one of the other criteria will be~     classified as an EDC donor.~      Hypothesis 1: Inhaled nitric oxide will improve overall outcome of liver recipients after EDC~     liver transplantation~        -  Suppression of oxidative injury will improve graft function postoperatively as measured~          by International Normalized Ratio (INR) bilirubin, transaminases, and duration of~          hospital stay.~      Hypothesis 2: The mechanisms of therapeutic efficacy of inhaled nitric oxide is based on~     reduction in post-reperfusion oxidative injury as readily measured by the detectable changes~     in the protein and metabolic profiles in plasma of patients treated with inhaled-NO~        -  Nuclear Magnetic Resonance (NMR)-based metabolic markers (xanthine end-products,~          lactate, and hepatic osmolytes) that are consistent with acute liver injury will be~          decreased in NO-treated recipients.~        -  Protein markers of reperfusion injury (argininosuccinate synthase (ASS) and estrogen~          sulfotransferase (EST-1) will be greater in the plasma of patients who are not treated~          with inhaled-NO~        -  Reduced oxidative injury will be reflected by a decrease in the number of mitochondrial~          peroxiredoxins isoforms and the number that are oxidized in NO-treated liver recipients.~   "
199748|NCT00948181|"~     Stress during surgery leads to significant increase in plasma catecholamine concentrations in~     surgeons, anesthesiologists, and patients.~   "
199749|NCT00948168|"~     The purpose of this study is to determine in type 2 diabetic patients in secondary failure to~     combined oral therapy whether, besides improvement in glycemic control, addition of~     exenatide, a new drug introduced to treat diabetes before addition of insulin to current~     therapy, over 6 months is associated with improvement in beta-cell function, insulin~     sensitivity following 24-hours discontinuation of the drug.~   "
199750|NCT00948155|"~     This study will demonstrate the behavioral responses to varenicline, helping to better~     understand its mechanisms. Hypotheses for the study are to observe decreases in smoking~     topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases~     on day 21 relative to day 7 during varenicline treatment. We also propose to examine if~     extended duration of treatment has clinical significance in decreasing smoking behaviors,~     thus increasing the efficacy of varenicline.~   "
199752|NCT00948129|"~     The goal of this study is to learn which of 3 methods is best for helping people quit~     smoking.~      Objectives:~      Specific Aim 1: Specific Aim 1: Compare the efficacy of three smoking cessation interventions~     targeting community based low-income uninsured and underinsured individuals in a~     group-randomized trial. The interventions will include a Standard Care (SC) approach,~     consisting of brief advice to quit smoking, nicotine replace therapy (NRT), and self-help~     written materials; an Enhanced Care (EC) approach, consisting of the standard care components~     and a cell phone-delivered text/graphical messaging component; and an Intensive Care (IC)~     approach, consisting of all SC and EC components plus a series of 11 cell phone-delivered~     proactive counseling sessions and a cell phone-delivered text/graphical messaging component.~      Hypothesis 1.1. Participants randomized to the EC condition will have higher smoking~     abstinence rates at 12-month follow-up compared to participants randomized to the SC~     condition.~      Hypothesis 1.2. Participants randomized to the IC condition will have higher smoking~     abstinence rates at 12-month follow-up compared to participants randomized to the EC~     condition.~      Specific Aim 2: Evaluate the role of quit motivation, nicotine withdrawal, risk perception,~     self-efficacy, social support, and negative affect as potential mediators of smoking~     abstinence~      Hypothesis 2.1: The EC's and IC's effects on abstinence will be mediated by quit motivation,~     nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect.~      Specific Aim 3: Compare the cost-effectiveness of the three treatment conditions.~      Hypothesis 3.1: Compared to SC and EC, the IC is a cost-effective use of health care~     resources.~   "
199753|NCT00948116|"~     Patients living with diabetes mellitus have double the risk of kidney failure compared to~     patients without diabetes following use of dye in many x−rays and procedures to diagnose and~     treat narrowing of the arteries (blood vessels) in the heart that can lead to angina or a~     heart attack. Heart disease is the commonest cause of death in patients with diabetes. People~     with diabetes are more likely to need these tests/treatments. By identifying those at greater~     risk of kidney complications we may be able to make these tests/treatments safer and offer~     them to more patients with diabetes.~   "
199754|NCT00948103|"~     Second line treatment for detrusor hyperreflexia is the intravesical BTX-A injections. First~     300 units Botox are diluted with 30 ml of preservative-free saline. Using a rigid cystoscope~     and an injection needle, BTX-A is injected into 30 sites within the detrusor muscle.~      The used of KALINOX® (50% nitrous oxide and oxygen) inhalation has demonstrated analgesic~     efficacy in various procedures (obstetric, liver biopsy, transrectal ultrasound guided~     prostate biopsy, emergency) The aim of this study is to investigate the safety and efficacy~     of analgesia with N2O/O2 inhalation for detrusor BTX-A injections using a rigid cystoscope.~   "
199755|NCT00948090|"~     This is a study for the outcome and safety of individualized busulfan dosing with~     cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat~     Non-Hodgkin or Hodgkin's Lymphoma.~   "
199756|NCT00948077|"~     The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of~     multiple doses orally administered first-line anti-tuberculosis drugs in subjects with~     pulmonary tuberculosis.~   "
199757|NCT00948064|"~     The goal of this clinical research study is to learn if the combination of azacitidine and~     vorinostat can help to control AML or MDS better than azacitidine alone. The safety of this~     drug combination will also be studied.~   "
199758|NCT00948051|"~     In this study the investigators hypothesized that the chronic intake of~     fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus~     vaccination and bifidobacteria in infants.~   "
199759|NCT00948038|"~     The objective of this study is to determine the acute effects of a dairy supplement compared~     to a soy supplement on oxidative and inflammatory stress in overweight and obese subjects in~     the absence of any changes in adiposity.~   "
199760|NCT00948025|"~     This study is a comparison of sensory recovery outcomes from the use of AVANCE and hollow~     tube conduits for peripheral nerve gap repairs in the hand.~   "
199761|NCT00948012|"~     Pulmonary hypertension (PH) at rest is a risk factor for death in patients with sickle-cell~     anemia (SCA). Exercise echocardiography (EE) can detect latent PH. We sought to investigate~     the occurrence of exercise-induced PH in patients with SCA and normal pulmonary pressure (PP)~     at rest, and its relationship with clinical and echocardiographic variables.Forty-four~     patients with SCA and normal PP at rest were studied and divided into two groups: exhibiting~     normal PP after treadmill EE (TRV≤2.7m/s) (G1), and exhibiting exercise-induced PH~     (TRV>2.7m/s) (G2). TRV cutoff points at rest and during exercise were based on data from~     healthy control subjects, matched for age, sex, and body surface area. Data obtained from EE~     were correlated with clinical, echocardiographic and ergometric variables.Exercise-induced PH~     occurred in 57% of the sample (G2), significantly higher than those of G1. Exercise-induced~     PH was related to higher levels of creatinine (p<0.05), increased left atrial volume (p<0.05)~     and right ventricular diastolic area (p<0.05), larger E/Em waves ratio derived from spectral~     and tissue Doppler (p<0.05), and higher TRV at rest (p<0.005).We concluded that patients with~     SCA and normal PP at rest may exhibit exercise-induced PH, which was related to renal~     function, increased cardiac chambers, abnormal indices of diastolic function and baseline TRV~     levels.~   "
199762|NCT00947999|"~     There has been little research on how chronic pain is related to brain activity. The purpose~     of this study is to learn more about pain and brain activity by finding any differences in~     brain activity among people who have moderate to severe chronic pain and a spinal cord~     injury, those who have a spinal cord injury but do not experience chronic pain, and people~     who have neither a spinal cord injury nor chronic pain (please note: subjects do not have to~     have pain to participate in this study). The information we collect will help the~     investigators get a better understanding of chronic pain.~   "
199763|NCT00947986|"~     The investigators are looking at the effects of baby shampoo nasal irrigation on the movement~     of mucous in the nose in patients who have undergone sinus surgery for chronic sinus~     problems.~   "
199764|NCT00947973|"~     This study will compare the efficacy and cost effectiveness of two methods of treating~     adolescents with attention deficit hyperactivity disorder in school.~   "
199765|NCT00947960|"~     The purpose of the study is to determine if triheptanoin is an effective treatment for the~     symptoms of Adult Polyglucosan Body Disease.~   "
227725|NCT00576576|"~     The purpose of this study is to evaluate the effects of Atorvastatin on the coronary~     atherosclerosis plaque morphology.~   "
199766|NCT00947947|"~     The purpose of the current study is to test a computerized HIV/STD prevention program with~     heterosexual African Americans. The hypothesis is that those exposed to the program will~     increase their correct and consistent use of condoms compared to those not exposed to the~     program.~   "
199767|NCT00947934|"~     Alzheimer's Disease (AD) is the most common cause of dementia. Today no treatment had shown~     consistent efficacy to stop or slow down the disease. Recent report of enhancement of memory~     abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the hypothalamus~     suggests that neuromodulation of circuits involved in memory processes may have therapeutic~     implications in AD patients with memory decline.~      The primary objectives of this prospective, non-controlled, pilot study are to assess the~     feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and~     to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD~     (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and~     specific impairment of episodic memory will be included in a 2-year period. The evaluation~     criteria for feasibility will be the proportion of patients undergoing the procedure, chronic~     stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated~     using numerous cognitive and memory testing including classical instrument used in AD~     clinical trials. Changes in behavioral scales, and changes in hypothalamic functions~     (clinical, biological and hormonal assessment) will evaluate safety and tolerance. Clinical,~     neuro-psychological, biological and imaging assessment will be performed 3 and one month~     before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will~     be implanted, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix,~     and then connected to the generator (Kinetra, Medtronic). Chronic high-frequency stimulation~     will be delivered immediately after surgery.~      The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and~     ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to~     AD patient the possibility to slow down/stabilize their symptoms, which no other treatment~     can currently offer, and to increase their quality of life.~   "
199768|NCT00947921|"~     Functional Mitral regurgitation is a now well known entity due to tethering of the valve~     either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in~     dilated cardiomyopathy. Treatment of this pathology, either conserving the valve and~     addressing regurgitation by mean of restrictive annuloplasty, or implanting a prosthesis~     remains controversial in terms of mid and long term benefit for the patient. The~     investigators propose a randomized controlled study to compare the efficacy of both technique~     in terms of mortality and freedom from reintervention.~   "
199769|NCT00947908|"~     Dendritic cells (DC) play a key role in the pathogenesis of allergic diseases. The regulation~     of blood dendritic cells in patients with hymenoptera venom allergy before and during immune~     therapy is unknown.~   "
199770|NCT00947895|"~     The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone)~     and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple~     Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV~     methylprednisolone.~   "
199771|NCT00947882|"~     A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to~     investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS)~     associated with benign prostatic hyperplasia (BPH)~   "
199772|NCT00947869|"~     The primary aim of the Erlangen´s Glaucoma Contrast Sensitivity-Study (EGCS-Study) is the~     evaluation of the diagnostic and prognostic validity of a diagnostic procedure, measuring~     contrast sensitivity. No therapeutic studies are performed.~   "
199773|NCT00947856|"~     This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with~     brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab~     vedotin study.~   "
199774|NCT00947843|"~     The purpose of this study is to compare the efficacy and tolerability between clopidogrel~     resinate and clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD~     equivalents.~   "
199775|NCT00947830|"~     The purpose of this study is to find out if the level of imatinib in the bloodstream, and the~     level that leukemia cells will predict how quickly your chronic myeloid leukemia improves~     with the treatment.~      1.1 Primary Objectives~      To determine if intracellular levels of Imatinib in leukemic blood cells within two weeks of~     treatment initiation of patients with chronic myeloid leukemia in chronic phase predicts~     molecular and cytogenetic response at 6 and 12 months post treatment~      1.2. Secondary Objectives~      1.2.1 To determine if hOCT-1 mRNA levels at diagnosis predict Imatinib intracellular levels~     within two weeks of treatment initiation.~      1.2.2 To determine the correlation between intracellular Imatinib levels at two weeks of~     treatment initiation with plasma Imatinib levels at two and four weeks after treatment~     initiation.~      1.2.3 To determine if plasma Imatinib levels four weeks after treatment initiation correlate~     with plasma Imatinib levels 12 months after treatment initiation.~      1.2.4 To determine if intracellular levels of Imatinib in leukemic blood cells within two~     weeks of treatment initiation correlate with intracellular levels of Imatinib in normal~     leukocytes 12 months after treatment initiation.~   "
199776|NCT00947817|"~     Prospective study including all the consecutive patients admitted at the Department of~     Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke~     criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched~     control subject will be included. Primary end point are EE occurring during the antimicrobial~     treatment and secondary end points will be 6-month mortality, vegetation length and the~     impact of antimicrobial treatment on inflammation-induced procoagulant changes and~     endothelial cell activation.~   "
199777|NCT00947804|"~     The Simple Acute Coronary Syndrome (SACS) Score was developed as a Risk Stratification Tool~     for Acute Coronary Syndrome (ACS). It is a tool which rates a patient's: SYMPTOMS, EKG~     FINDINGS, RISK FACTOR PROFILE, and CARDIAC MARKERS on a scale of zero to six.~      The purpose of this study is to validate the SACS Scoring tool by establishing a correlation~     between the score's numerical values and the degree of obstructive cardiovascular disease~     visualized during cardiac catheterization.~   "
199778|NCT00947791|"~     The purpose of this study is to determine whether a single intravenous administration of an~     N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar~     depression.~   "
199827|NCT00947154|"~     No medication has been reliably shown to benefit those suffering from trichotillomania~     (compulsive hair pulling). The current study proposes to evaluate the effectiveness of the~     medication aripiprazole for treatment of trichotillomania (TTM). Patients will take a~     gradually increased dose of the medication in an open-label study to see whether it relieves~     hair-pulling urges, decreases hair pulling behavior and is well tolerated.~   "
200283|NCT00941161|"~     The aim of the study is to determinate the effect of combined oral therapy of long acting~     metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and~     monotherapy failure.~   "
199779|NCT00947778|"~     The cochlear implant appears today as one of the best technique so as to lead the congenital~     deaf children to speak. However the results in terms of accurate access to language remain~     partial. These results are usually due to the children own factors (social, educational and~     handicap ones), one which any action has a limited effect.~      Besides, there are external factors on which one can rely :  treatments . For instance, an~     early cochlear implant on a child is the main stream to a better access to speak properly~     later. Another essential point to tackle is the early re-education training which remains~     essential to the treatment. Yet, there is a gap to fill between the theory and the main~     assistance in the auditory education practice.~      The main objective of this survey is to evaluate the efficiency of this auditory teaching~     programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of~     sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf~     children aged from 4 to 10.~      This study will be divided into two phases separated by 3 sessions of evaluation tests.~      The first session T1 will occur in the two groups (experimentation on G1 and control on G2),~     then the first training session will start in group G1.~      The second session T2 will occur in the two groups, then the first training session will~     start in group G2.~      The third session T3 will occur in the 2 groups at the end of the experiment.~      By training the 4 perceptible operations with different auditory stimulations (speech, music,~     sounds and electro-acoustic sounds), we are looking for better performance in the trained~     skills as well as a teaching transfer on other linguistic abilities (phonetics discrimination~     and speech).~   "
199780|NCT00947765|"~     Lateral epicondylitis, is a common problem encountered in the orthopaedic practice.~     Histopathological reports have shown that lateral epicondylitis is not an inflammatory~     process but a degenerative condition termed 'tendinosis'. Beneficial effects of local~     corticosteroid infiltration have sound lack of scientific rationale, since surgical specimens~     show lack of any inflammatory process. Recently an injection of autologous blood injection~     has been reported to be effective for both intermediate and long term outcomes. It is~     hypothesized that blood contains platelet derived growth factor induce fibroblastic mitosis~     and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate~     and specialize and have been found to induce healing cascade. The objective of the study is~     to evaluate the efficacy of autologous blood injection versus local corticosteroid injection~     in the management of lateral epicondylitis.~   "
199781|NCT00947752|"~     The purpose of this study is to compare pain associated with injections and injection-site~     reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational~     formulation of GA. In addition, the investigators will evaluate the side effects of the two~     formulations of GA.~   "
199782|NCT00947739|"~     This is a phase I and pharmacology study of Camptothecin-20-O-Propionate Hydrate (CZ48) in~     Patients with Solid Tumors or Lymphoma.~      OBJECTIVES~      Primary:~        1. To describe the dose limiting toxicities and adverse event profile of~          Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day.~        2. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48)~          administered orally every day.~           Secondary:~        3. To perform a pharmacokinetic study of orally administered CZ48 in the plasma.~        4. To assess responses by RECIST criteria.~        5. To follow patients for survival.~   "
199783|NCT00947726|"~     We believe that using a ceramide based foot cream two times a day for two weeks will prevent~     water loss and overall foot dryness in patients with non-insulin dependent diabetes.~   "
199784|NCT00947713|"~     The purpose of this study is to compare the effectiveness of low dose human chorionic~     gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its~     endocrine response in patients who had previously failed to ovulate on clomiphen citrate~     alone. The investigators will also compare the effectiveness and endocrine response of this~     approach with the regimen of adding HMG to clomiphen citrate.~   "
199785|NCT00947700|"~     Early connections has two broad goals:~        -  to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants~          who have an older sibling with ASD or infants who have an older neurotypical sibling.~        -  to assess whether it is possible to alter risk processes through early intervention with~          high-risk infants, thereby reducing social-communication delays or the severity of~          autism symptoms.~   "
199786|NCT00947687|"~     The objectives of the study are to demonstrate the effectiveness, safety and tolerability of~     multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults~     experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus.~   "
199787|NCT00947674|"~     This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.~   "
199788|NCT00947661|"~     A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy~     and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar~     active ingredient but containing a different preservative as that in Reference0912. Patients~     with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to~     receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.~   "
199789|NCT00947648|"~     The purpose of this study is to evaluate the infection rate of leukemia patients who eat two~     different diets. Patients in the raw group will eat cooked food and the addition of raw~     fruits and vegetables. Patients in the cooked group will eat only cooked foods and this is~     the standard neutropenic diet with no fresh fruits or vegetables allowed. The primary~     objective of the study is to evaluate the infection rate of leukemia patients who eat two~     different diets. The secondary objectives will be the incidence of fever requiring~     intravenous antibiotics in each group and death rate.~   "
199790|NCT00947635|"~     The purpose is to investigate possible mechanisms of increased blood lipid levels following~     transplantation, and also to see if a comprehensive dietary intervention is effective in~     reducing blood lipid levels in post-transplant patients.~   "
199791|NCT00947622|"~     The aim of this study is to investigate whether transcranial direct current stimulation is~     effective in the treatment of fibromyalgia related pain. The study provides a placebo arm and~     the design is a cross-over design.~   "
199877|NCT00946504|"~     To demonstrate the relative bioequivalency comparing Geneva's 10 mg Glipizide tablets to~     Roerig's 10 mg Glucotrol tablets.~   "
199878|NCT00946491|"~     To demonstrate the relative bioequivalency of generic Haloperidol tablets versus Haldol in~     normal volunteers.~   "
199792|NCT00947609|"~     The study is a prospective study to improve the diagnosis and management of latent TB in~     HIV-infected and HIV uninfected children in Thailand. The objectives are to assess the~     sensitivity and specificity of IGRAs (T-Spot®.TB, a T-cell-based assay, and QuantiFERON®-TB~     Gold In-tube, a whole blood assay), TST, and a refined symptom-based questionnaire in~     diagnosing latent TB in 166 HIV-infected and HIV uninfected children in Thailand, and to~     evaluate the influence of age, nutritional and immune status on children's response to the~     IGRAs. These children will be screened for TB with a detailed TB contact history,~     symptom-based questionnaire, physical examination, TST, chest radiograph (and abdominal~     ultrasound for those with abdominal symptoms), IGRAs, and clinical specimens for acid fast~     bacilli stain and culture. A diagnostic algorithm will be generated using the combination of~     test modalities with the highest sensitivity and specificity results.~   "
199793|NCT00947596|"~     MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This~     pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by~     the ADPI to atropine delivery from the AtroPen autoinjector.~   "
199794|NCT00947583|"~     This study is being conducted to determine the percentage of patients with solid spinal~     fusions after being treated with Osteocel Plus in a TLIF procedure. Due to the unique~     processing conditions, Osteocel Plus retains a high concentration of stem cells in~     conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with~     Osteocel Plus will be comparable to published data for autograft. The Osteocel product family~     has already been used in approximately 15,000 cases worldwide.~   "
199795|NCT00947570|"~     This study will examine the effects of cognitive behavioral therapy on brain function in~     people with anxiety disorders.~   "
199796|NCT00947557|"~     This study will evaluate the safety and efficacy of dutogliptin in patients with type 2~     diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without~     metformin.~   "
199797|NCT00947544|"~     Protocol HPN-100-005 was the first study of HPN-100 in pediatric subjects with urea cycle~     disorders (UCDs) and was a fixed-sequence, open-label, switch over study of HPN-100 with a~     long-term (12 month) safety extension designed to assess the safety of HPN-100 and to~     prospectively assess its ability to control blood ammonia as compared with Sodium~     Phenylbutyrate (NaPBA). Upon DSMB review of the first ten subjects who completed the switch~     over part of the study, and with DSMB approval, up to an additional 20 subjects were enrolled~     into the safety extension part of the study. HPN-100 is a triglyceride that has a similar~     mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of~     HPN-100 (~17.4mL) delivers an equivalent amount of PBA to 40 tablets of NaPBA.~   "
199798|NCT00947531|"~     This clinical trial was performed to assess the clinical efficacy and safety of two 4 week~     treatment courses of daily intravenous administration of Cerebrolysin (20mL [milliliter] IV~     [intravenous] per day). The study was performed as prospective, randomised, double-blind,~     placebo-controlled, parallel group, multicentre study with 2 study groups.~      Group 1: 20 mL Cerebrolysin and 100 mg (milligram) acetylsalicylic acid Group 2: Placebo~     (0.9% NaCl [sodium chloride]) and 100 mg acetylsalicylic acid The study drug was given once~     daily by intravenous infusion (20ml in 250ml saline solution) for 4 weeks on five consecutive~     days per week. This treatment regimen was repeated after a two-month treatment-free interval.~     Acetylsalicylic acid was given orally, once daily throughout the study duration of 24 weeks.~      Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24~     were necessary.~   "
199799|NCT00947518|"~     The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine~     affects skin condition, temperature, and bacterial colonization in stable preterm (28-36~     weeks gestational age) low birth weight (1001-2000 g) infants admitted in a health facility.~   "
199800|NCT00947505|"~     The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam~     model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment~     is applied as directed.~   "
199801|NCT00947492|"~     PBMNC DNA is considered a limit above which patients will develop EBV associated post~     transplant lymphoproliferative disorder.~      we showed that methotrexate tended to decrease EBV load over time, but this did not reach~     significance and that TNFa inhibitors did not significantly modify EBV load over time.~      Our objective is to monitor Epstein Barr Virus load over time in patients with Rheumatoid~     arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab), to detect possible~     immunosuppression associated EBV dysregulation, as seen in post transplant~     lymphoproliferative disease.~   "
199802|NCT00947479|"~     Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an~     increasing medical problem with important social and financial implications worldwide. OSA is~     a well established risk factor for systemic hypertension myocardial infarction or stroke and~     it has been documented that blood pressure rises in a very consistent fashion during apneic~     episodes. The incidence of the episodes of apnea during sleep causes repeated subclinical~     acute kidney injuries (AKI) contributing to the development of CKD. One of the mechanisms~     responsible for AKI might be endothelial injury followed by an increase of central aortic~     pressure.~   "
199803|NCT00947466|"~     The purpose of this study is to characterize the pharmacokinetics and tolerability of~     buprenorphine patches in children who require opioid pain relief for moderate to severe mouth~     pain.~   "
199804|NCT00947453|"~     Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These~     enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a~     predominant role in ECM homeostasis, but it is now clear that they have much wider~     functionality. An imbalance between MMP activity and that of their inhibitors (tissue~     inhibitors of metalloproteinases, TIMPs) is considered to play a critical role in the~     synthesis or degradation of the extracellular matrix of the airway architecture which results~     in fixed airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD).~     Using quantitative real time polymerase chain reaction (RT-PCR) the investigators have~     identified a difference between the level of steady state mRNA for MMP-9, MMP-14 and MMP-2 in~     2 patients with asthma compared to 4 healthy controls using our method. However the~     investigators require further refinement of the process in order to optimise RNA quality and~     to evaluate the effect of montelukast across the entire family of MMPs and their inhibitors~     (TIMPs).~   "
230080|NCT00545025|"~     The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after~     revaccination.~   "
199806|NCT00947427|"~     Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1~     class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the~     bioactivity of this pro-inflammatory cytokine.~      The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical~     trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous~     injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive~     standard intensive diabetes treatment with insulin and dietary management.~      Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12~     injections over one year.~      All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up~     until study end. Enrollment is expected to occur over two years.~   "
199807|NCT00947414|"~     Hypothesis: The combination of extracorporeal shockwave and a daily gluteal muscle strength~     programme is superior to the gluteal muscle strength programme alone in cellulite.~      Study design: Randomized-controlled trial~      Analysis: Intention-to-treat~      Outcome parameters: a) Photo, b) Nürnberger Score, c) circumference measurements, d)~     capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow~      Intervention: Extracorporeal shock wave for six sessions with 2000 impulses at both gluteal~     and thigh regions plus a specific gluteal strength exercise training~      Follow-up: 12 weeks~   "
199808|NCT00947401|"~     The objective of the present study is to describe the current practice of postoperative fluid~     management in the Post Anesthesia Care Unit (PACU) of the Shaare Zedek Medical Center,~     Jerusalem, Israel.~   "
199809|NCT00947388|"~     This phase I trial is studying the side effects and best dose of alemtuzumab when given~     together with bendamustine hydrochloride in treating patients with relapsed chronic~     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that did not respond to~     fludarabine phosphate. Drugs used in chemotherapy, such as bendamustine hydrochloride, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can also block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or carry cancer-killing substances to them.~     Giving bendamustine hydrochloride together with alemtuzumab may kill more cancer cells.~   "
199810|NCT00947375|"~     The purpose of this study is to determine the effect of lamotrigine augmentation of~     Haloperidol decanoate in the treatment of Resistant Schizophrenia predominantly by verbal~     resistant hallucinosis: A randomized, double-blind, placebo-controlled, study.~      Nadir A.Aliyev & Zafar N.Aliyev~      Central Mental Clinic for Outpatients of Baku city of Azerbaijan Republic~      Abstract:~      OBJECTIVE: The current paper reports on a double-blind, randomized study of the role of~     lamotrigine as an augmentation agent to haloperidol decanoate in the treatment of out~     patient's schizophrenia with verbal resistant hallucinosis.~   "
199811|NCT00947362|"~     The aim of the randomized double blind trial with 134 patients presenting old world cutaneous~     leishmaniasis is:~        -  to evaluate the clinical efficacy of electro-thermo-cauterisation (ETC) followed by~          moist wound treatment versus ETC followed by moist wound treatment plus 0.05 %~          pharmaceutical chlorite that has been used in three European countries (Germany, Austria~          and Switzerland) in wound care management for more than 20 years;~        -  to judge whether early wound care management would present a viable improvement to the~          actual anti-parasitic treatments mostly neglecting the chronic wound problem and to~          evaluate its long-term effect on immunity through relapse control 6 months after wound~          healing.~   "
199812|NCT00947349|"~     The current Standard of Care (SOC) for chronic HCV infection, which is pegylated~     interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is~     effective in only part of the patients and is often associated with severe adverse effects~     leading to discontinuation of treatment and dose modifications.~      A number of compounds with direct activity are currently under clinical development, incl. BI~     201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to~     the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see~     how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN~     and RBV in HCV infected patients~   "
199813|NCT00947336|"~     Background: Spontaneous bacterial peritonitis (SBP) is a serious complication in patients of~     cirrhosis with ascites and may occur despite antibiotic prophylaxis. Small bowel dysmotility~     and bacterial overgrowth have been documented to be related to SBP. Aims: To investigate~     whether addition of prebiotic plus probiotics (synbiotics) to norfloxacin enhances the~     efficacy of norfloxacin in prevention of SBP in high risk patients with ascites.~      Methods: A prospective, double blind, randomized controlled trial was conducted in~     consecutive high-risk cirrhotic patients with ascites who had either recovered from an~     episode of SBP (secondary prophylaxis) or who never had SBP but were at high risk for~     development of SBP (low ascitic fluid protein or serum bilirubin ≥2.5 mg/dL; primary~     prophylaxis). Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis~     JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million,~     Lactobacillus sporogenes 50 million spores) 2 t.i.d. (group I) or norfloxacin 400 mg once~     daily with placebo (group II) was given and occurrence of SBP within a period of 6 months~     (primary endpoint) or side-effects of therapy and mortality (secondary endpoints) were~     recorded. Every patient received IV albumin to maintain a serum albumin level of >3.2 g/dl.~     SBP was treated with intravenous antibiotics with albumin.~   "
199814|NCT00947323|"~     This is a randomized clinical trial, double-blind, placebo controlled, to verify if~     simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any~     cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function,~     improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in~     improvement of erection.~   "
199815|NCT00947310|"~     This study will assess the impact of higher rate cutoffs and longer delays than standard~     programming on inappropriate therapy in primary prevention ICD and CRT-D patients.~   "
199816|NCT00947297|"~     This was a long-term safety study HPN-100 in urea cycle disorder (UCD) subjects. Subjects~     were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events~     were characterized with respect to contributing factors, such as intercurrent illness, diet,~     and noncompliance with medication.~   "
201860|NCT00920244|"~     The purpose of this study is to analyse transitions in cardiac rhythm and hemodynamic~     variables during resuscitation of patients with in-hospital cardiac arrest.~   "
199817|NCT00947284|"~     In previous clinical studies of post-surgical pain the investigators found that nalbuphine~     (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose~     naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was~     particularly true in men. The purpose of this study is to find out if nalbuphine combined~     with naloxone is more effective in relieving experimentally produced pain than either drug~     alone. A second reason for this study is to find out if study medications work more~     effectively in women or in men. Subjects will come to the University of California at San~     Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a~     2-hour screening to assess the subject for study eligibility. During the other three visits,~     the investigators will use a thermal stimulating device to produce temporary, non-injurious~     skin sensitivity that subjects will feel as painful. Changes in pain will be measured~     following the intravenous (i.v.) administration of study drugs. Three drug combinations will~     be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2)~     naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug~     combinations will be administered in random order; all subjects will receive all three~     combinations.~   "
199818|NCT00947271|"~     This study will determine whether showing an educational DVD to people at sexually~     transmitted infection clinics can reduce incidence of new infections and risky sexual~     behaviors and improve overall health.~   "
199819|NCT00947258|"~     The stretching is performed within sports to improve muscle performance and prevent muscle~     injury. However, recent studies are contradictory with common practice. Then raised the~     possibility that stretching before physical activity performed can decrease the muscle~     performance of healthy subjects.~   "
199820|NCT00947245|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics~     following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.~   "
199821|NCT00947232|"~     This study compares two approaches to helping people who are aging with MS or SCI and are~     experiencing depressed mood to become more physically active. The study is carried out~     entirely by telephone. There is no need to travel and participants may reside anywhere within~     the United States. We will examine the effects of the intervention on overall physical~     activity, mood, pain, fatigue and general health. Participants will complete surveys over the~     phone throughout the study and wear an activity monitor 3 times. The study is 6 months in~     length and participants may receive up to $120 for their time and effort.~   "
199822|NCT00947219|"~     The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks~     compared to baseline measurements.~   "
199823|NCT00947206|"~     This proposed project seeks to expand understanding of what constitutes a lay health worker~     (LHW), how those characteristics determine the effectiveness of LHWs as health educators on~     colorectal cancer (CRC) screening, and the relationship of those characteristics to a~     particular community and culture. Using quantitative and qualitative methods and a~     community-based participatory research (CBPR) approach, the project will develop and~     implement a group randomized controlled trial to evaluate LHW effectiveness in promoting CRC~     screening among Chinese Americans age 50 to 75 with a pilot component to evaluate the role of~     Traditional Chinese Medicine (TCM) healers as health educators.~      The investigators will conduct focus groups with community participants to revise training~     materials developed in a prior pilot project. The investigators will also conduct~     ethnographic observations of TCM healers and focus groups with their clients to refine the~     training materials. The investigators will recruit 26 LHWs to be assigned to the intervention~     arm and 26 to the comparison arm. The LHWs will each recruit 12 participants from their~     social network for a total of 312 participants in each arm. The intervention group~     participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing~     their CRC screening receipt. The comparison group will receive a bilingual CRC brochure as~     well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO~     session on CRC screening. Effectiveness of the intervention will be measured by~     pre-intervention and post-intervention surveys of community participants' CRC screening~     behaviors, with validation of self-reports. An additional 10 TCM healers will also~     participate as LHWs. They will each recruit 12 participants for LHWO. There will be extensive~     ethnographic observations as well as post-intervention focus groups of LHWO activities, LHWs,~     and LHWO participants to assess the factors that contribute to effective LHWO.~      The primary hypothesis is that the increase in the proportion of participants who report ever~     having had a CRC screening test in the experimental group (LHWO about CRC) will be greater~     than the increase in the comparison group (nutrition education + CRC brochure).~   "
199824|NCT00947193|"~     Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations~     in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are~     essential for blood clotting. The lack of FVIII/FIX can produce bleeding episodes that cause~     damage of the bone, muscles, joints, and tissues. A specific type of mutation, called a~     nonsense (premature stop codon) mutation, is the cause of the disease in approximately 10-30%~     of patients with hemophilia and results in severe manifestations. Ataluren (PTC124) is an~     orally delivered, investigational drug that acts to overcome the effects of the premature~     stop codon, potentially enabling the production of functional FVIII/FIX. This study is a~     Phase 2a trial evaluating the safety and efficacy of ataluren in patients with HA or HB due~     to a nonsense mutation. The main purpose of this study is to understand whether ataluren can~     safely increase FVIII/FIX activity levels.~   "
199825|NCT00947180|"~     This study has been completed. The following is a brief description of the aims, methods, and~     results of the study:~      Previous small studies suggest that chronic proctalgia (chronic recurring pain in the anal~     canal or rectum), which is also called levator ani syndrome, can be treated with biofeedback~     to teach relaxation of pelvic floor muscles, or electrogalvanic stimulation (electrical~     stimulation to relax muscles), or massage of pelvic floor muscles. The aim of this study was~     to compare the effectiveness of these three treatments, to determine how they work~     physiologically, and to identify which patients are most likely to benefit.~      Methods: Subjects had to meet the diagnostic criteria for chronic proctalgia and to report~     pain at least once a week. They had to also be free of medical or psychiatric disorders that~     could explain their chronic proctalgia. Patients qualified to enter the study were separated~     into two groups based on whether they reported tenderness when the examining physician~     pressed on the levator ani muscles of the pelvic floor. All 157 patients who were enrolled~     received 9 sessions of psychological counseling plus biofeedback or electrogalvanic~     stimulation or massage. The results of treatment were assessed at 1, 3, 6, and 12 months~     after the end of treatment.~   "
199826|NCT00947167|"~     To determine objective response rates (RR) by RECIST guideline version 1.1 for all patients~     treated with this strategy consisting of initial therapy with pertuzumab as a single agent~     and then addition of erlotinib for those who have stable disease or progressive disease at~     three months (Simon design).~   "
199879|NCT00946478|"~     The purpose of this study is to determine the effect of topical pimecrolimus on the immune~     system by assessing the levels of antimicrobial peptides in the skin of patients with eczema.~     It is hypothesized that pimecrolimus applied topically will repair the body's immune system~     in patients with eczema by increasing antimicrobial peptides.~   "
199828|NCT00947141|"~     This study aims to determine: a) whether those patients with 'low level' viral load results~     (between 200 and 3,000 copies/ml) could be monitored as opposed to starting preemptive~     therapy with valganciclovir, ganciclovir and/or foscarnet; b) whether those patients with~     'high level' viral load results (above 3,000 copies/ml) could stop preemptive therapy~     earlier, thus maximising the benefits of therapy and minimising its risks.~   "
199829|NCT00947128|"~     To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under~     non-fasting conditions.~   "
199830|NCT00947115|"~     Infection with human papillomavirus (HPV) has been clearly established as the necessary cause~     of cervical cancer. This study is designed to evaluate the long-term immunogenicity and~     safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the~     first dose of HPV vaccine (Month 0) in primary study NCT 00196937. This protocol posting~     deals with objectives & outcome measures of the extension phase from Year 5 to Year 10. The~     objectives & outcome measures of the primary phase and extension phase up to year 4 are~     presented in a separate protocol posting (NCT 00196937).~   "
199831|NCT00947102|"~     Observational study of influence of gemcitabine treatment on serological and immunological~     status and gene expression profile in patients with pancreatic tubular carcinoma after tumor~     resection.~   "
199832|NCT00947089|"~     The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is~     effective to reduce the risk of surgical site infections (SSI).~   "
199833|NCT00947076|"~     To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.~   "
199834|NCT00947063|"~     To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under~     fasting conditions.~   "
199835|NCT00947050|"~     The purpose of this study in humans with stable coronary artery disease (CAD) treatable by~     PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to~     an instantaneous improvement of coronary collateral function.~   "
199836|NCT00947037|"~     An extension of study IN 09 004 testing the long term safety of the Accordion Pill~     Carbidopa/Levodopa (AP-CD/LD)~   "
199837|NCT00947024|"~     To demonstrate the effect of food on the bioavailability of Glipizide.~   "
199838|NCT00947011|"~     This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a~     naturally occurring hormone) on insulin release and to examine whether there is extra insulin~     release when GLP-1 is not allowed to be rapidly inactivated.~   "
199839|NCT00946998|"~     This is a randomized double-blinded placebo-controlled trial to see if treatment with~     sertraline as compared with placebo tablets will improve depression symptoms in patients with~     chronic kidney disease who have not yet started dialysis or received a kidney transplant. The~     investigators will also investigate whether sertraline treatment will improve quality of life~     and whether it is safe to use in patients with kidney disease. The study subject will be~     randomly assigned to take either sertraline or a placebo tablet for 12 weeks.~   "
199840|NCT00946985|"~     The study will assess the use of paliperidone palmitate compared with oral risperidone in~     delaying time to relapse in patients recently diagnosed with schizophrenia who are at high~     risk of relapse.~   "
199841|NCT00946972|"~     This study will assess the safety, tolerability, pharmacokinetics (explores what the body~     does to the drug), and pharmacodynamics (explores what a drug does to the body) of multiple~     doses of JNJ-38431055 in volunteers with type 2 diabetes mellitus.~   "
199842|NCT00946959|"~     The real impact of cardiac surgery and coronary angioplasty remains to be clarified and,~     where appropriate, the influencing factors in a way beneficial or deleterious remain to be~     identified.~      The identification of such factors could make even faster screening, prevention and therefore~     open therapeutic prospects for those patients.~      The objective of the study is to constitute a prospective cohort to assess the occurrence of~     cognitive decline after cardiac surgery (200 patients) and coronary angioplasty (200~     patients) using the scale Dementia rating scale (DRS) of Mattis. In addition, the~     investigators will identify factors that influence positively or negatively, the occurrence~     of such a cognitive decline. The study based on a systematic monitoring of clinical,~     biological, imaging and pharmacological factors and, to correlate the respective influence of~     these factors on the incidence of cognitive decline.~   "
199843|NCT00946946|"~     This study aims to compare azathioprine versus mesalazine tablets for the prevention of~     clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe~     endoscopic recurrence.~   "
199844|NCT00946933|"~     Approximately 30% of people aged 65 years and older experience breathlessness (perceived~     respiratory difficulty) during daily activity. The main causes of increased breathlessness in~     the healthy elderly are poorly understood and are the main focus of the proposed study. Some~     possible contributing factors include abnormalities in the control and/or mechanics of~     breathing. To evaluate these possible contributory factors, the investigators will compare~     ventilatory and perceptual responses to: 1) exercise, 2) increased levels of inspired carbon~     dioxide, and 3) reduced levels of inspired oxygen under strictly-controlled experimental~     conditions where the investigators increase or decrease breathing requirements by altering~     dietary salt intake in healthy 40-80 year old men and women.~      Exercise and rebreathing tests will be performed at baseline and at the end of each 3 day~     treatment period. Breathlessness intensity will be measured and compared at a standardized~     work rate, ventilation or end-tidal PCO2 during these tests.~   "
199845|NCT00946920|"~     A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of~     degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in~     patients with prostate cancer.~   "
199880|NCT00946465|"~     To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under fasting~     conditions.~   "
199881|NCT00946452|"~     To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma~     sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in~     Malaysia.~   "
199934|NCT00945750|"~     This study will determine whether the CT formulation of famotidine taken with and without~     water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under~     the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single~     dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg~     FCT with water.~   "
199846|NCT00946907|"~     Treatment of pericarditis largely remains empirical due to the relative lack of randomized~     controlled trials. Nevertheless, some recommendations have been formulated to guide~     management and follow-up of acute pericarditis. Aspirin or an NSAID at medium to high dosages~     is the mainstay of treatment. Optimal length of treatment is not established.~      PERICARDITE is a French multicentric placebo controlled double blind randomized trial~     assessing efficacy of a brief treatment based on Aspirin (4 days) versus a longer treatment~     (21days) in treating a first episode of probably idiopathic acute pericarditis. It is a non~     inferiority trial.~      Exclusion criteria are: diseases known to cause pericarditis: (recent myocardial infarction,~     autoimmune disease, postpericardiotomy syndromes, connective tissue disease, tuberculosis,~     neoplastic disease).~      Primary endpoint is: 30 days recovery defined as the normalization of all clinical and~     paraclinical initial abnormalities.~      Secondary endpoint is: 6-month recurrence.~   "
199847|NCT00946894|"~     The aim of this three-arm randomized study was to evaluate results of different thyroid~     resection modes among patients with bilateral multinodular non-toxic goiter, with special~     emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.~   "
199848|NCT00946881|"~     The aim of this study is to determine the optimal treatment conditions (WST11 dose and light~     energy dose) to achieve ablation in one lobe of the prostate and to evaluate the safety and~     quality of life of WST11 medicated Vascular-Targeted Photodynamic therapy (VTP) in men with~     localized prostate cancer.~   "
199849|NCT00946868|"~     Metabolic syndrome, a group of cardiovascular risk factors related to insulin resistance, is~     a major determinant of cardiovascular mortality.~      Intermittent claudication is a symptom of an early stage of atherosclerosis.~      The aim of this study is to determine the prevalence of the metabolic syndrome in patients~     with intermittent claudication and its correlation with age, gender, localization of arterial~     obstruction and association with coronary artery disease.~   "
199850|NCT00946855|"~     Repeated blood sampling within a regular soccer season of German first league clubs shall~     serve to define soccer-specific reference values for routine parameters determined from~     venous blood. It was hypothesized that only for a minor number of parameters common reference~     values will have to be adapted for soccer players during their competitive season.~   "
199851|NCT00946842|"~     The purpose of this study is to determine the relative oral bioavailability (the extent to~     which a medication or other substance becomes available to the body as compared with another~     form of medication or other substance) of TMC207 after single-dose oral administration of the~     Phase II clinical study tablet formulation, and a newly developed tablet formulations, under~     fed (with food) and fasted (without food) conditions.~   "
199852|NCT00946829|"~     The aim of the observational study is to ascertain the degree of blood pressure control in~     the early-morning hours after 8 weeks of treatment with~     Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients~     with hypertension using home blood pressure measurements.~   "
199853|NCT00946816|"~     Diseases characterized by abnormal low and high body weight are common in the community and~     are associated with significant morbidity, mortality and health care related costs.~      Genetic, dietary, social and psychologic factors all play an important part in these~     conditions; however the central role of gastrointestinal (GI) function and the control of~     nutrient delivery to the small bowel has not been well described in health or disease.~      We propose that the GI response to feeding varies inversely with body weight. This hypothesis~     predicts that as body weight increases, the response to a given meal decreases in terms of~     motility, neurohormonal feedback, sensation and satiety. This provides an attractive~     explanation for why thin individuals stop eating after a small amount of food (i.e. limited~     gastric relaxation, rapid gastric emptying, powerful nutrient feedback with early~     satiety)and, conversely, why obese patients continue to eat even after nutritional~     requirements have been met (i.e. large gastric relaxation, slow gastric emptying, weak~     nutrient feedback with delayed satiety).~      This project will apply MRI and Breath Tests to assess GI motility, hormonal feedback,~     visceral sensation and satiety in patients with pathologically low (anorexia nervosa) and~     high (morbid obesity) body weight and in healthy, normal weight controls.~      Participants will include: Group A: normal weight, healthy volunteers (n=24: BMI: 18.5-24.9~     kg/m2) Group B: patients with anorexia nervosa (DSMIV criteria and BMI: <16 kg/m2) B1:~     anorexia restricting type (n=12-20 over 2 years) and B2: anorexia bulimia type (n=20 over 2~     years) Group C: patients with morbid obesity (BMI: 30-40 kg/m2) C1: obese (n=20 over 2 years)~     and C2: obese with DM type II (n=20 over 2 years).~      Two studies will be performed~        1. Cross-sectional study: The effects of a test meal on GI motility, hormonal feedback,~          visceral sensation and satiety in healthy controls and in patients with anorexia and~          obesity~        2. Longitudinal study: The effects of dietary treatment (i.e. weight change) on GI~          motility, hormonal feedback, visceral sensation and satiety in patients with anorexia~          and obesity~   "
199854|NCT00946803|"~     Patients receiving treatment for advanced cancer often experience co-occuring pain, fatigue,~     and sleep disturbance that are not relieved with medications. Brief cognitive-behavioral~     coping strategies such as relaxation or imagery have been shown to be useful for these~     symptoms individually and may be effective for the cluster of co-occuring pain, fatigue, and~     sleep disturbance. Because single cognitive-behavioral strategies don't work equally well for~     all persons, providing training in multiple cognitive-behavioral strategies is necessary.~     However, oncology nurses report having insufficient time and are often not available to~     deliver the interventions exactly when patients experience symptom exacerbation. This~     application proposes a patient-controlled cognitive-behavioral (PC-CB) intervention, using an~     MP3 player to deliver recorded cognitive-behavioral strategies. The PC-CB intervention would~     allow patients to select from a variety of cognitive-behavioral strategies based on their~     personal preferences, and facilitate self-administration of those strategies at whatever time~     and place the symptoms occur, without increasing burden on nursing staff. Primary aims are~     (1) to explore acceptability and patterns of use of the recorded cognitive-behavioral~     strategies and (2) to pilot test efficacy of the PC-CB intervention compared to a waitlist~     control.~   "
199855|NCT00946790|"~     To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.~   "
199856|NCT00946777|"~     The primary objective is to determine if there is a correlation between reductions in corneal~     staining and improvements in corneal barrier function.~   "
199857|NCT00946764|"~     To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50~     mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.~   "
199858|NCT00946751|"~     To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750~     mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.~   "
199859|NCT00946738|"~     The effect of deep oscillation and biofeedback on Raynaud`s phenomenon secondary to systemic~     sclerosis (SSc) remains to be determined. A prospective randomized controlled pilot study was~     performed in SSc patients receiving either deep oscillation, biofeedback thrice a week for~     four weeks or were randomized to the control group.~   "
199860|NCT00946725|"~     To demonstrate the relative bioavailability of atenolol tablets, 100 mg.~   "
199861|NCT00946712|"~     This randomized phase III trial studies carboplatin and paclitaxel to compare how well they~     work with or without bevacizumab and/or cetuximab in treating patients with stage IV or~     non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs~     used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that~     tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and~     interfering with a protein on the surface of the tumor cell that is needed for tumor growth.~     It is not yet known whether giving carboplatin and paclitaxel are more effective with or~     without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer.~   "
199862|NCT00946699|"~     The primary objective of this study is to evaluate the safety and tolerability of~     intravenously administered MEDI-551 over escalating single doses in adult subjects with~     Scleroderma~   "
199863|NCT00946686|"~     To demonstrate the relative bioavailability, parallel study Of Leflunomide 20 mg tablets~     under fasting conditions.~   "
199864|NCT00946673|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat~     given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer~     (NSCLCA) brain metastases in patient with 1-4 lesions.~   "
199865|NCT00946660|"~     This research deals with behaviors that are part of drug dependence. The purpose is to study~     how certain factors, including money, the amount of drug available, and the amount of work~     effort, affect cocaine drug choice. Specifically, we will examine the effects of two~     issues/factors. The first is how hard individuals are willing to work to obtain a drug; the~     second is how much drug would individuals choose instead of money, when the amount of~     probability of money is predictable or unpredictable.~   "
199866|NCT00946647|"~     The purpose of this randomized, two-arm, open-label expansion phase study is to collect~     preliminary efficacy data of panobinostat at the recommended phase II dose (RPIID) level in~     combination with azacytidine (5-Aza) versus an active control arm 5-Aza alone. This~     randomized phase II part allows also collecting safety data of panobinostat in combination~     with 5-Aza in comparison to single-agent 5-aza.~   "
199867|NCT00946634|"~     The ozone therapy has been coming up as a new therapeutic modality. Medicine has been~     practicing since XIX century and counted great results. It is indicated for the treatment of~     260 different pathologies. The researches in Dentistry has showed promising results,~     indicating a wide spread action in whole dental specialties. The great oxidative power of~     ozone provides a great antimicrobial effect and it increases the adenosine triphosphate (ATP)~     synthesis that can be considered as a general improvement of the cell metabolism, which can~     potentize the repair process. Thus, these facts justify the present study which will assess~     the increase of speed of apical periodontite repair.~   "
199868|NCT00946621|"~     To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under~     non-fasting conditions.~   "
199869|NCT00946608|"~     To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.~   "
199870|NCT00946595|"~     A 2-year multicenter, phase II/III, randomized active-controlled trial to evaluate the~     efficacy and tolerance of two maintenance strategies in HIV-1 infected patients with HIV RNA~     below 50 copies/mL : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy~     (EFV/FTC/TDF).~   "
199871|NCT00946582|"~     The purpose of this study is to explore the therapeutic effects of Barkley's parenting~     management program for Taiwanese school-aged children with ADHD. The investigators~     hypothesized that Barkley's parenting management program might empower the parents'~     competence to manage their school-aged children's ADHD-related disturbing behaviors as its~     previously-proven effects for parents and their preschool-aged children with ADHD.~   "
199872|NCT00946569|"~     The purpose of this study is to evaluate the safety and effectiveness of once daily oral~     administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with~     persistent asthma.~   "
199873|NCT00946556|"~     Herpes simplex virus type 2 (HSV2), the most common cause of genital herpes, increases a~     woman's risk of HIV acquisition from 3-6 fold, perhaps because HSV2-infected women have~     increased numbers of HIV target cells (CD4 T cells and dendritic cells) in the cervical~     mucosa. However, recent clinical trials showed no impact of HSV2 suppression on HIV~     acquisition rates. The reasons for this negative result are unclear. The investigators~     propose to examine the effect of valacyclovir (a widely used herpes medication) treatment on~     cervical immunology and HIV target cells in the cervix. The study will take the form of a~     randomized, double-blind, placebo-controlled crossover trial. Primary endpoints will be (1)~     the number of CD4 T cells on a cervical cytobrush and (2) the number of immature dendritic~     cells per cervical cytobrush.~   "
199874|NCT00946543|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation~     therapy in treating patients with prostate cancer.~   "
199875|NCT00946530|"~     The aim of this study is to demonstrate the efficacy of timed exposure to bright light for~     the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia~     patients and their caregivers, and to determine if there are genetic relationships between~     memory problems and sleep problems~   "
199876|NCT00946517|"~     This study will test the hypothesis that certain parenting styles are associated with greater~     non-adherence to therapy in children and teens with type 1 diabetes. To test their~     hypothesis, the investigators will use standardized and validated questionnaires for parents~     and children to determine: parenting styles (the investigators will measure parental~     strictness, parental attachment, and parental monitoring), parent ability to cope with~     stress, parent comfort with the parenting role, parent and child level of depression and~     parent perception of financial resources. The investigators will also measure parent and~     child's perception of the child's underlying temperament and parent-child conflict. The~     investigators will correlate these findings with both parent and child subjective measures of~     adherence to therapy. The investigators will also obtain objective measures of therapy~     adherence including: HbA1c, number of hospitalizations for diabetes ketoacidosis and number~     of missed outpatient appointments. These measures will be correlated with our other findings.~   "
199882|NCT00946439|"~     The purpose is to evaluate the effects of adding a wheel assisted running training (WART) to~     a conventional mixed physical activity training (CT) program on walking and gross motor~     function in trained children with cerebral palsy (CP).~      Method entails recruiting thirty children with CP (16 females, 14 males), with mean (SD) age~     11.8 (3.5) and training experience 3.4 (3.5), years were assigned to either WART or CT~     groups. The energy Expenditure Index (EEI), the Gross Motor Function Measure 66 (GMFM),~     self-selected and fast walking velocity (SSV and FV, respectively), and cadence are~     administered by a trained physical therapist. The intervention period is six months, with two~     sessions per week.~   "
199883|NCT00946426|"~     24 children (12 African-American, Hispanic, or American Indian, 12 Caucasian) previously~     diagnosed with type 1 diabetes mellitus will participate in this pilot study to evaluate the~     presence of hepatic and peripheral insulin resistance. The investigators will use this pilot~     information to test the hypothesis that insulin resistance occurs in some children with type~     1 DM, is secondary to underlying risk factors, and is responsible for increased insulin~     needs. Methods will include a step-up hyperinsulinemic euglycemic clamp and infusion of the~     stable isotope 6,6-[2H2]-glucose. Patient and parent interviews will be conducted to gather~     information about nutritional intake, ethnicity, family history, and socioeconomic status.~     The investigators will also measure inflammatory cytokines and free fatty acids to determine~     whether they are associated with differences in insulin resistance among type 1 diabetes~     mellitus patients.~   "
199884|NCT00946413|"~     Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has~     potential in preventing and treating adolescent depression. The purpose of this study was to~     compare the short- and long-term effectiveness of CBT alone and CBT plus parental education~     for community-based adolescents at risk for depression and suicide in Taiwan. It is~     hypothesized that the CBT alone and CBT with parental education group are more effective than~     the control group.~   "
199885|NCT00946400|"~     The purpose of this study is to evaluate a scoring tool to help determine the presence of~     Heparin Induced Thrombocytopenia (HIT), which is an adverse reaction to heparin. We~     hypothesize that this scoring tool will be very useful in excluding patients who are~     suspected of having HIT.~   "
199886|NCT00946387|"~     To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under~     fasting conditions.~   "
199887|NCT00946374|"~     The purpose of this study is to improve the overall survival of Mantle-Cell-Lymphoma (MCL) by~     a new concept of treatment with primary curative intention consisting of six courses of~     immunochemotherapy followed by high-dose chemotherapy and autologous stem cell~     transplantation (SCT) and HLA-identical allogenic SCT after a dose-reduced conditioning~     regimen of total body irradiation (TBI) with 2 Gy and Fludarabine in younger patients with~     primary Mantle-Cell-Lymphoma~   "
199888|NCT00946361|"~     The investigators will prospectively recruit 26 children with moderate - severe active Crohn~     disease (PCDAI >30). Results will be compared to 26 patients in sustained remission (PCDAI~     <10 and physician global assessment of remission over the previous 6 months) who are matched~     for age and gender. Subjects will be studied at baseline and six months. The primary study~     end-points will be leucine rate of appearance (a measure of protein breakdown) and IGF-1~     levels.~      This study will test the hypothesis that children with greater disease severity will have~     worse longitudinal growth and protein catabolism. The investigators will also explore the~     secondary hypothesis that children with Crohn disease have abnormal IGF-1 generation which is~     linked to underlying inflammation and disease severity.~   "
199889|NCT00946348|"~     The first aim of this study is to determine whether a brain reward center (BRC) deficiency in~     patients with schizophrenia (SCZ) and cannabis use disorder (CUD) will be normalized when~     patients are given cannabis or dronabinol. The second aim will serve to further assess the~     effects of dronabinol on symptoms and medication side effects in this population.~   "
199890|NCT00946335|"~     This phase I trial is studying the side effects and best dose of ABT-888 when given in~     combination with temozolomide in treating young patients with recurrent or refractory CNS~     tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving ABT-888 together with temozolomide may kill more tumor cells.~   "
199891|NCT00946322|"~     The purpose of this study is to develop and test a couple-based treatment for Veterans with~     an alcohol use disorder and post-traumatic stress disorder.~   "
199892|NCT00946309|"~     The investigators proposed to identify the biological effects of a high-sulforaphane broccoli~     sprout extract in normal prostate tissue.~      The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract~     every other day will inhibit growth of prostate cancer cells.~   "
199893|NCT00946296|"~     The purpose of this study is to determine whether a brief course of SSKI (saturated solution~     of potassium iodide) administered preoperatively provides any benefit in the surgical~     management of patients undergoing thyroidectomy as definitive management of their Graves~     Disease.~   "
199894|NCT00946283|"~     RATIONALE: Probiotics, such as Lactobacillus, may be effective in preventing infections in~     patients with suppressed immune systems.~      PURPOSE: This phase I trial is studying the side effects and how well giving enteral~     nutrition, including Lactobacillus, works in preventing infections in patients undergoing~     donor stem cell transplant for hematologic cancer or myelodysplastic syndrome.~   "
199895|NCT00946270|"~     The goal of this clinical research study is to learn if CC-4047 (now called pomalidomide) and~     prednisone can help to control MMM. The safety of this therapy will also be studied.~   "
199896|NCT00946257|"~     This study will assess the subcutaneous administration of otelixizumab to T1DM patients. The~     study will provide safety, tolerability, pharmacodynamic and pharmacokinetic information~     which will enable the identification of appropriate safe and well-tolerated subcutaneous~     dosage regimens to be used in subsequent clinical studies. This study will consist of a~     screening phase, followed by an in-house phase whereby otelixizumab will be administered to~     cohorts that will be staggered at each dose level.~   "
199931|NCT00945789|"~     In this prospective trial the investigators plan to study the efficacy of erythropoietin as a~     therapeutic agent in neonates who suffer from brain injury following perinatal asphyxia.~   "
199897|NCT00946244|"~     The main purpose of this study is to extend the investigators' previous research to~     longitudinally examine the effectiveness of three early intervention programs: usual care~     program, clinic-based intervention program and home-based intervention program for very low~     birth weight preterm children at 3 and 4 years of age. Normal weight full-term children will~     also be included to serve as the reference group. Effectiveness assessments will include~     child, parenting, and transactions measures. Child outcome measures will include health~     status, growth, neurodevelopment and behavior; parenting outcome measures will include~     parental stress, competence, efficacy and family support; transactions outcome measure will~     include parent-child interaction procedures.~   "
199898|NCT00946231|"~     The HABIT clinical study is being performed to determine the benefit and optimal frequency~     for at home testing of B-type natriuretic peptide (BNP) for heart failure patients following~     hospitalization from decompensation. Subjects will be enrolled following hospitalization for~     decompensated heart failure. Enrolled subjects will be trained on the use of the Triage Touch~     meter for fingerstick BNP assessment; these subjects will then test their BNP levels daily~     using the Triage Touch product for approximately 60 days.~   "
199899|NCT00946218|"~     Dengue virus is an arbovirus transmitted by mosquitoes which causes significant morbidity and~     mortality among children in tropical regions, especially in resource limited countries. The~     objective of this protocol is to compare the sensitivity and specificity of clinical gestalt~     and two rapid antigen tests for dengue virus and to compare the gene expression of leukocytes~     in distinct dengue fever disease phenotypes module-based RNA microarray technology.~   "
199900|NCT00946205|"~     The aim of the present prospective, double-blind, randomized study is to study whether~     laparoscopic anterior mesh rectopexy is as good as laparoscopic posterior rectopexy with~     respect to obstructive defecation afterwards.~   "
199901|NCT00946192|"~     One aim of this study is to determine changes in body composition and hormones that~     differentiate athletes who stop getting their periods versus those who continue to get their~     periods and non-athletes. The second aim of this study is to determine whether transdermal or~     oral estrogen (versus no estrogen) is effective in increasing bone density and improving bone~     microarchitecture in adolescent athletes who are not getting their periods and are thus~     estrogen deficient. The investigators hypothesize that transdermal estrogen will be more~     effective than oral estrogen or no estrogen in improving bone health in amenorrheic~     adolescent athletes.~   "
199902|NCT00946179|"~     This study is in support of the annual application for the variation of the vaccine strains~     for a marketing authorization.~      Objectives:~        -  To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split~          virion, inactivated) Northern Hemisphere (NH) 2009-2010 formulation in two adult groups,~          aged 18 to 60 years and aged 61 years or older.~        -  To describe the safety of the influenza vaccine (split virion, inactivated) NH 2009-2010~          formulation in both adult groups.~   "
199903|NCT00946166|"~     The investigators are conducting a study to determine the effects of a cholesterol-lowering~     medication, called simvastatin on pneumonia. People in the study will be in the hospital~     because they have pneumonia. The people will also have a medical condition like heart~     disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has~     been shown to prevent future disease and/or death but are not taking a cholesterol-lowering~     medication when they go to the hospital. Some people will get treated with antibiotics only~     and other people will get antibiotics and simvastatin while they are in the hospital. The~     study will compare the effects the combination of simvastatin and antibiotics has on people~     with pneumonia to treatment with antibiotics alone.~   "
199904|NCT00946153|"~     The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and~     tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is~     administered continually once daily in patients with advanced hepatocellular carcinoma.~   "
199905|NCT00946140|"~     The purpose of this study is to develop new image analysis method using Dynamic Contrast~     Enhanced Magnetic Resonance Imaging (DCE-MRI) for ovarian cancer. MRI is not currently part~     of the standard care for ovarian cancer. In this method, a contrast agent is used to make~     ovarian cancer visible during imaging.~   "
199906|NCT00946127|"~     The purpose of this study is to test and compare the efficacy of Endoscopic Third~     Ventriculostomy with shunting of Cerebrospinal fluid (CSF)for treatment for patients of~     Normal pressure Hydrocephalus.~   "
199907|NCT00946114|"~     The purpose of this study is to provide sildenafil therapy to eligible adult patients with~     pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study~     for the treatment of PAH in Poland. Only safety and tolerability data will be collected in~     these patients.~   "
199908|NCT00946101|"~     The purpose of this study was to determine the safety and descriptive immunogenicity of the~     H1N1 influenza vaccine in healthy children.~   "
199909|NCT00946088|"~     Preterm delivery is the most common cause of infant morbidity and mortality in the United~     States. Some women have episodes of preterm labor during their pregnancy which can be~     temporarily stopped. These women, however, are at high risk for delivering before term. At~     this time, we do not have sufficient evidence to use any medication to help prevent these~     women from delivering early. Recently, preliminary studies have shown that progesterone may~     help prevent some women at high risk for preterm delivery from delivering early. Our study~     will investigate whether progesterone can help this specific group of women, women with~     arrested preterm labor, deliver healthy infants at term.~   "
199910|NCT00946062|"~     The purpose of this study is:~        1. to develop a standardised orientation and mobility training (O&M-training) in the use of~          an identification/symbol cane by older adults with low vision, and;~        2. to evaluate this newly developed standardised O&M-training with respect to effectiveness~          and feasibility in a randomised controlled trial.~   "
199911|NCT00946049|"~     Antibacterial Triclosan-coated suture material (VICRYL PLUS®, Ethicon) and non-coated~     (VICRYL®) was compared for bacterial colonization after third molar extraction. Sutures were~     removed postoperatively and adhered bacteria were investigated.~   "
199912|NCT00946036|"~     -  Objective:~             -  To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited,~               India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100~               mg tablet, under fasted conditions.~        -  Study Design:~             -  Single-dose, open-label, randomized two-way crossover.~   "
199913|NCT00946023|"~     This phase II trial is studying how well giving fludarabine and cyclophosphamide together~     with total-body irradiation and rituximab works in treating patients with B-cell lymphoma or~     chronic lymphocytic leukemia who are undergoing an allogeneic (donor) bone marrow transplant.~     The type of bone marrow transplant is a less intensive or mini transplant using a relative~     as the bone marrow donor. The donated bone marrow stem cells may replace the patient's immune~     system cells and help destroy any remaining cancer (graft-versus-tumor effect). Patients~     undergoing this type of transplant often have more than one relative who could be a donor.~     The trial is also studying a new way of choosing amongst possible donors which might improve~     how the rituximab works.~   "
199914|NCT00946010|"~     The purpose of this study is to investigate the differences of genotypes of hepatitis B and~     hepatitis C in Taiwan.~   "
199915|NCT00945997|"~     To compare the efficacy of two different dose regimens of misoprostol administered vaginally~     in combination with mifepristone in second trimester termination of (non)viable pregnancy.~   "
199916|NCT00945984|"~     Surgical resection is the only potential curative treatment available for renal cell~     carcinoma. The purpose of this study is to clarify the surgical and oncologic outcomes of~     laparoendoscopic single-site radical nephrectomy for localized Renal Cell Carcinoma.~   "
199917|NCT00945971|"~     The study will investigate catecholamines responses, and cognitive effects of exercise in~     children with attention deficit hyperactivity disorder, and the effect of exercise training~     on these measures.~   "
199918|NCT00945958|"~     The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter,~     open label, non-randomized, uncontrolled, single group assignment, safety study of subjects~     with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive~     study medication for a period of 24-weeks.~   "
199919|NCT00945945|"~     The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces~     pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.~   "
199920|NCT00945932|"~     This study will measure the effect of repeat inhaled doses of GW870086X on lung function.~   "
199921|NCT00945919|"~     This project will explore the safety and feasibility of performing a successful intravenous~     patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER~     Oxymorphone (extended release or OPANA ER) in the outpatient setting.~   "
199922|NCT00945906|"~     Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with~     potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose~     blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual~     clotting process, thereby preventing bleeding.~      In this study, patients will be treated with FXIII Concentrate (Human) and followed closely~     to determine that they receive the dose of FXIII Concentrate (Human) that will best minimize~     the chance of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate~     (Human) to patients until the product becomes commercially available in the United States.~   "
199923|NCT00945893|"~     The purpose of this study was to determine the safety and descriptive immunogenicity of the~     H1N1 influenza vaccine in healthy adults.~   "
199924|NCT00945880|"~     The purpose of this study is to test the hypothesis that clemizole hydrochloride is safe and~     well tolerated when administered to subjects who are infected with hepatitis C virus and have~     not yet received treatment. This study will also examine how the virus and body respond to~     clemizole hydrochloride.~   "
199925|NCT00945867|"~     The determination of the 2D6 genotype will enable us to determine the way flecainide is~     metabolized by the liver. Some individuals are poor metabolizers and some individuals are~     extensive metabolizers of the drug. This will also determine which patients will benefit from~     the drug.~   "
199926|NCT00945854|"~     A diet with the multiple beneficial characteristics of whole grains and, more in general, of~     healthy cereals favorably influences glucose and insulin metabolism in subjects with~     metabolic syndrome. Therefore, the aim of the study is to evaluate the long term effects of a~     diet containing healthy cereals versus a control diet, on glucose and insulin metabolism in~     subjects with metabolic syndrome.~   "
199927|NCT00945841|"~     This study is an annual trial for registration of inactivated split influenza vaccine with~     strain composition for season 2009/2010.~   "
199928|NCT00945828|"~     Neurodevelopmental outcomes in children treated for cancer involving the central nervous~     system (CNS) provide educators with new challenges with regards to classification,~     monitoring, and intervention in the regular or special education classroom setting.~     Recommendations resulting from serial neurodevelopmental evaluations for these children often~     do not overlap with traditional special education recommendations commonly included in~     Individual Education Plans (IEPs) for children with congenital or genetic learning problems.~     The investigators currently do not know whether or not school-based treatment for learning~     problems, based on the child's IEP, incorporates recommendations made based on a~     neurodevelopmental evaluation appropriately. In addition, it is not clear whether or not the~     recommendations that are included in a child's IEP have any beneficial outcome on the child's~     learning and academic achievement over time. The purpose of this project is to examine the~     relationship between neurodevelopmental outcomes, recommendations for intervention, special~     education services and accommodations included in a child's school IEP, and outcome for the~     child following implementation of the IEP. The study has two major specific aims:~        1. To quantify the clinical and educational contributions of recommendations resulting from~          neurodevelopmental evaluations and the subsequent development of IEPs.~           Hypothesis 1.1: Higher concordance between recommendations made based on~          neurodevelopmental evaluations and criteria written into children's IEPs will be~          associated with more positive academic outcomes (i.e. maintenance or improvement in~          academic skills).~           Hypothesis 1.2: Children who have higher concordance between criteria written into their~          IEPs and academic services actually received will show more positive academic outcomes~          than children whose IEP criteria and academic services are less concordant.~        2. To evaluate an intervention that will improve academic outcomes for children treated for~          cancer.~      Hypothesis 2.1: Children whose IEPs are monitored more frequently will show more positive~     academic outcomes than their peers whose IEPs are monitored less frequently.~   "
199929|NCT00945815|"~     RATIONALE: Monoclonal antibodies, such as epratuzumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving epratuzumab together~     with cytarabine and clofarabine may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab~     together with cytarabine and clofarabine works in treating patients with relapsed or~     refractory acute lymphoblastic leukemia.~   "
199930|NCT00945802|"~     The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in~     the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug~     Application in support of FST-201 for the indication of acute otitis externa.~   "
199932|NCT00945776|"~     The purpose of this study is to compare the effects of three interventions on CPAP adherence.~   "
199935|NCT00945737|"~     The objectives of the trial are to determine whether a non-commercial soy protein product,~     consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol~     (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and~     affects other aspects related biomarkers.~   "
199936|NCT00945724|"~     This trial is a phase II non-comparative study aimed to determine the feasibility and~     toxicity of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and~     systemic intermediate-dose methotrexate followed by loco-regional radiotherapy.~   "
199937|NCT00945711|"~     The purpose of this study is to analyze a chart audit of patients seen at Park Nicollet~     Eating Disorder Institute (EDI) to identify and compare general characteristics of eating~     disorders with type 1 diabetes patients to a matched eating disordered population without~     type 1 diabetes, also seen at EDI.~   "
199938|NCT00945698|"~     The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have~     been associated with improved growth and development outcomes among infants in Ghana and~     Malawi. Modified versions of such supplements have been developed to improve their nutrient~     density and quality and to lower their costs. Such modified products have proven acceptable~     to infants and their guardians in Malawi and Ghana. In the present trial, the investigator~     aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the~     investigators will test a hypothesis that LNS that does not contain milk promotes growth as~     well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month~     old infants in rural Malawi.~   "
199939|NCT00945685|"~     Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis~     and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin~     dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen~     modification, skin laxity and cellulite (dermis and hypodermis).~      EndyMion has developed the Imagine™ system - Computerized Radiofrequency System for Skin~     Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern~     can be produced allowing to selectively heating one or more of the target tissues (epidermis,~     dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be~     targeted, creating enough thermal effect to induce collagen remodeling with no ablative~     thermal damage in the epidermis or dermis. This post marketing study is intended for~     evaluation of safety and efficacy of the Imagine™ system.~   "
199940|NCT00945672|"~     The purpose of this study is to determine whether multiple dose administration is safe and~     well tolerated in patients with mild to moderate Alzheimer's Disease.~   "
199941|NCT00945659|"~     The incorporation of continuous glucose sensors (CGS) into management of type 1 diabetes in~     adolescence could improve treatment outcomes. But, behavioral barriers may prevent~     adolescents from enjoying optimal benefits from this new technology. This study will~     randomize adolescents (11 to not yet 17 years old) with type 1 diabetes for at least 2 years~     who are not achieving targeted HbA1c levels (> 7.5%) to continue in standard care (SC), to~     add continuous glucose monitoring (CGM) to their care with appropriate education and medical~     management (CGS) or to add CGM to their care as above but to also receive support and~     assistance from a behavior therapist who will assist the patient and family in optimizing the~     adolescents' therapeutic benefit from CGS (CGS+BT). A variety of outcomes will be measured,~     including blood glucose control, quality of life, and CGS satisfaction and impact. An~     enrollment criterion for this study is that the adolescent must have established consistent~     care for type 1 diabetes at a Nemours Children's Clinic location either in Wilmington, DE,~     Philadelphia, PA, Orlando, FL or Pensacola, FL for at least 12 months prior to enrollment in~     the study. Adolescents treated elsewhere are not eligible to enroll in the study.~   "
199942|NCT00945646|"~     The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the~     treatment of acute fungal otitis externa. This trial is designed to enable filing of a New~     Drug Application in support of FST-201 for the indication of acute fungal otitis externa.~   "
199943|NCT00945633|"~     Dietary intervention and other strategies to prevent unhealthy weight gain and the~     development of obesity should be based on knowledge of dietary, physiological, genetic and~     behavioral determinants and their contributing interactions. Identifying these determinants~     is difficult because physiological susceptibility to specific dietary and behavioral factors~     implicated in unhealthy weight gain differs between populations and individuals within the~     populations. The research challenge is identifying specific determinants in a free-living,~     adult population.~      Understanding the interaction between diet and the underlying susceptibility factors such as~     physiologic, genetic and epigenetic, and behavioral factors mandate an integrated approach.~      This integrated approach should include understanding the interplay of physiological factors~     (genetics, epigenetics, taste preferences, susceptibility to energy excess, etc.) and~     behavioral factors (food cravings, restraint, disinhibition, physical activity) as each of~     these domains is a potential driving force in energy expenditure, food preference, dietary~     choices, and food intake.~      Which of these factor(s) is most important? The investigators propose that by examining~     dietary, physiological, genetic, and behavioral factors in an integrated fashion we will gain~     insight into the obesity epidemic and identify the most important determinants of weight~     gain. As a secondary aim, the investigators will identify a single parsimonious collection of~     factors and develop strategies to mitigate the risks of developing obesity.~   "
199956|NCT00945464|"~     Breast cancer is a disease of complex origin with a strong genetic component. The incidence~     of breast cancer is very high in monozygotic twins of patients, and it is thought that a high~     proportion and perhaps the majority of breast cancers arise in a small number of genetically~     susceptible women. Recent studies in human genetics have discovered several intervals in the~     human genome containing inherited variants that are statistically associated with the~     propensity to develop breast cancer. The investigators plan to use this knowledge to design a~     genetic screening test to guide recommendations for breast cancer screening with mammography.~     If the small group of genetically susceptible women can be identified, more effective breast~     cancer screening strategies can be implemented. In contrast, a very large proportion of women~     who undergo yearly mammography are at exceptionally low risk from a genetic perspective.~     Using genomic guidance could eventually reconfigure the most efficacious strategy to screen~     women for early detection of breast cancer.~      By developing a genetic screening panel based on genetic markers for breast cancer, the~     investigators will be able to more accurately determine a woman's individual risk for~     developing breast cancer.~   "
199944|NCT00945620|"~     The primary aim of this study is to measure the magnitude and duration of trans-abdominis~     plane (TAP) block analgesia in parturients undergoing elective cesarean section with~     concurrent standard of care operative analgesic regimens including intrathecal morphine~     sulfate (ITMS). A one sided block model takes advantage of the bilateral nature of the pain~     created by a bilateral surgical wound and allows each patient to serve as her own control.~     Reduced variability allows a more definitive establishment of analgesic benefit for this~     block.~      The current reports of conflicting data regarding efficacy make uncertain the role of TAP~     block in post cesarean section pain relief. This model would have a better potential for~     measuring the block's effectiveness. Quantitative sensory evaluation tools such as the von~     Frey hair tool provides a quantitative reproducible measure of skin sensation and also allows~     for assessment of block regression over time. Pressure algometry has been established as a~     clinical and research tool for quantitative assessment of pain levels in multiple pain~     conditions. A useful inexpensive reliable pressure algometer has recently been described.~      The assessment of serum ropivicaine levels with this block will provide useful data regarding~     the systemic absorption of local anesthetic compared to other peripheral nerve blocks and~     establish the safety of the technique.~      In addition this study will help establish a model for the study of TAP block modifications~     in the future. If block effectiveness is demonstrated, this model can be used to examine~     numerous block parameters including choice of local anesthetic and dose response analysis for~     optimal volume and concentration. Potential future study may be done also in the area of~     adjuncts found to have increased duration and effectiveness as used in other peripheral nerve~     blocks.~      Expected duration of this study is 18 months.~   "
199945|NCT00945607|"~     The primary objectives of this study are to determine if the use of Guided Relaxation~     Training (GRT) during cancer treatment in individuals with newly diagnosed breast cancer~     increases their ability to cope as measured by the Coping Self-Efficacy Scale (CSES) and~     reduces their perceived stress as measured by the Perceived Stress Scale (PSS).~   "
199946|NCT00945594|"~     The primary purpose of this study to assess patient pain scores comparing rigid to flexible~     cystoscopy in females; to assess post procedural complications, including frequency, urgency,~     infection and time to resolution of these symptoms between the two procedures; to assess~     physician perception of patient pain or discomfort with flexible or rigid cystoscopy.~   "
199947|NCT00945581|"~     The primary objectives are to evaluate the effect of AN777 on muscle strength loss that~     occurs during bed rest, and to investigate whether AN777, in association with resistance~     training, will support muscle strength recovery following bed rest in healthy elderly~     subjects.~   "
199948|NCT00945568|"~     The aims of this study are (1) to study the benefit of branched-chain amino acids enriched~     nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the~     duration of hospitalization after the surgery, and (2) To investigate the postoperative~     quality of life (QOL) in receiving peri-operatively branched-chain amino acids enriched~     nutrient-mixture in patients who undergone the hepatic management for hepatocellular~     carcinoma (HCC) with chronic liver disease.~   "
199949|NCT00945555|"~     The purpose of this study was to define and classify antibacterial agents used in Turkey for~     patients with febrile neutropenia.~   "
199950|NCT00945542|"~     Background: Bleeding and coagulopathy still accounts for the majority of early in-hospital~     deaths following trauma. There have been lately several published studies suggesting that~     higher transfusion ratios of fresh frozen plasma (FFP), platelets (PTL) and cryoprecipitate~     (CRYO) to red blood cell (RBC) are associated with survival advantages. However, the evidence~     comes from retrospective data limited by a significant number of unaddressed confounders. In~     addition, the use of blood products bears known and important risks of complications.~      Hypothesis: The adoption of a formula-driven transfusion practice with pre-defined ratios of~     FFP to PTL to RBC transfusion (1:1:1) is feasible and superior to current laboratory-guided~     transfusion practice in treating and/or preventing early coagulopathy improving survival~     rates in massively bleeding trauma patients .~      Objective: To exam the feasibility of implementing a pre-defined ratio of FFP to PTL to RBC~     (1:1:1) transfusion protocol and its impact on a population of bleeding trauma patients.~      Design: A two-year pilot feasibility randomized control trial at Sunnybrook Health Sciences~     Centre. Randomization: 70 patients are expected to be randomized to lab-driven or to~     formula-driven massive transfusion protocol and followed-up to 28 days or hospital discharge.~      Study outcomes: protocol violation; in-hospital mortality by exsanguination; death at 28~     days; coagulation competence defined by current standard coagulation tests (INR & PTT < 1.5~     times normal; PTL ≥ 50 and Fibrinogen ≥ 1.0) or clotting factor levels ≥ 30%; correlation of~     current standard coagulation tests with clotting factors levels; cessation of bleeding;~     incidence of ALI, sepsis, MOF, transfusion-related circulatory overload, transfusion~     reactions; Ventilator-free days; ICU & Hospital LOS; thromboembolic events.~      Intervention protocol: Transfusion of pre-defined ratios of FFP and PTL to RBC (1:1:1)~     (formula-driven) for the first 12h of hospitalization without coagulation tests guidance~     while patient is hemorrhaging or before if bleeding stops.~      Statistical analysis: protocol compliance rate and in-hospital mortality rates within 24h and~     at 28 days will be assessed using Chi-square test. ROC analysis will be used to analyze~     coagulation competence.~      Main expected outcomes: implementation of a formula-driven transfusion protocol is feasible~     and coagulation competence will be achieved faster and more efficiently in the study group.~   "
199951|NCT00945529|"~     Pleural effusions continue to be a post-operative complication seen after Fontan operation.~     This study will examine the use inhaled nitric oxide given for 54 hours after Fontan~     operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after~     Fontan operation will improve fluid balance, thus decreasing the incidence of pleural~     effusions and shortening hospital stay.~   "
199952|NCT00945516|"~     The purpose of this study is to determine the feasibility, easy removability, safety, and~     migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring~     FCSEMS for benign biliary stricture.~   "
199953|NCT00945503|"~     A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over~     time for GSK1018921.~   "
199954|NCT00945490|"~     This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the~     treatment of BPH (benign prostatic hyperplasia) as compared to placebo.~   "
199955|NCT00945477|"~     A growing body of literature supports the role of angiogenesis in the development and spread~     of a variety of human cancers including prostate cancer.~        -  Vascular endothelial growth factor (VEGF) expression is low in normal prostate tissue,~          but markedly increased in tumor tissues, and has a positive association with tumor stage~          and grade~        -  Plasma VEGF levels are significantly elevated in patients with hormone refractory~          prostate cancer (HRPC) compared to those patients with localized disease and have been~          associated with disease progression in other cancer patient population.~        -  The Cancer and Leukemic Group-B demonstrated that VEGF levels correlate with survival.~      Pazopanib is a potent multi-target receptor tyrosine kinase inhibitor of vascular endothelial~     growth factor receptors.~   "
199957|NCT00945451|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less~     damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic~     radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well~     it works in treating patients with stage III non-small cell lung cancer.~   "
199958|NCT00945438|"~     This study is in support of the annual application for the variation of the vaccine strains~     for a marketing authorisation.~      Objectives:~        -  To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the~          intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation.~        -  To describe the safety of the corresponding strength of the ID influenza vaccine, NH~          2009-2010 formulation.~   "
199959|NCT00945425|"~     The purpose of this study is to evaluate the safety and tolerability after repeated ascending~     doses of AZD7325 in Japanese healthy male subjects.~   "
199960|NCT00945412|"~     The ultimate goal of this work is to establish a method for control bleeding after~     tonsillectomy in awake children. Treatment of post-tonsillectomy bleeding in children~     typically requires general anesthesia with currently used electrocautery techniques.~     Micropolysaccharide hemosphere technology is a unique absorbable agent that helps clot form.~     These hemospheres consist of 100% purified plant starch that enhances natural clotting by~     concentrating blood solids such as platelets, red blood cells, and blood proteins on the~     particle surfaces to form a gelled matrix. This device provides painless, non-irritating~     control of bleeding, and has been used effectively for control of nosebleeds in awake adult~     patients. This device, however, has not been tested in the tonsillar fossae in children;~     thus, this study is performed to determine if at least 50% of children with bleeding~     tonsillar fossae can be spared rescue treatment with electrocautery.~   "
199961|NCT00945399|"~     CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a~     matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted~     protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial,~     sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare~     the clinical improvement of the IKDC subjective score between the microfracture-treated group~     and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several~     secondary objectives were determined. The microfracture procedure will be conducted in one~     operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two~     operative steps:~        1. Arthroscopy to collect cartilage;~        2. Implantation following arthrotomy about 6 weeks following arthroscopy.~      Both groups will follow the same rehabilitation program.~   "
199962|NCT00945386|"~     Pediatric patients, during their illness often treated with furosemide (Lasix) continuous~     drip, often, with dosages above 4-6mg/kg/day (the recommended dose).~      This study will monitor hearing status of these children prior to their therapy with~     furosemide, during this therapy and after.~   "
199963|NCT00945373|"~     The purpose of this study is to determine the efficacy of calcium dobesilate in combination~     with pulsed dye laser for the treatment of rosacea.~   "
199964|NCT00945360|"~     Fibroids are benign tumors that might results in bleeding. Surgery is their definitive~     treatment. Some medical therapies have been tried for women who wish to preserve their~     uterus. Recent reports have demonstrated a role for a new category of drugs called aromatase~     inhibitor (such as Femara) in the treatment of fibroids. This study is conducted to assess~     the effect of Femara (letrozole) on the size of fibroids in women around menopause.~   "
199965|NCT00945347|"~     The purpose of this study is to investigate within a short delay the effect of nasal~     instillation of Miglustat on nasal potential difference in cystic fibrosis patients~     homozygous for the F508del mutation.~   "
199966|NCT00945334|"~     In this study the investigators aim to compare the efficacy of neomycin to a combination of~     rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test.~     This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in~     Scottsdale, AZ and Dr. Satish Rao in Georgia Regents University in Augusta, GA.~   "
199967|NCT00945321|"~     This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a~     single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food~     on the bioavailability of oral aprepitant.~   "
199968|NCT00945308|"~     The achievement of high local concentration of Eptifibatide, a GP 2b3a inhibitor,via direct~     intracoronary injection, promotes (in vitro) clot disaggregation. It remains unclear if it is~     of superior benefit than the routine intravenous administration of these agents.~      In patients presenting with acute myocardial infarction, and undergoing primary coronary~     intervention, intracoronary administration of Eptifibatide may increase local drug~     concentration by several orders of magnitude and promote clot disaggregation with a minimal~     increase in systemic drug concentration, and in that way enhancing myocardial perfusion and~     survival.~   "
199969|NCT00945295|"~     The purpose of this study is to determine if a combination of botulinum neurotoxin A and~     rehabilitation therapy is better than botulinum neurotoxin A alone for improvement in~     function based on the Fugl-Meyer and other validated measures.~      Hypothesis: The combination of botulinum neurotoxin A and rehabilitation therapy will produce~     better functional improvement than botulinum neurotoxin A alone in post-stroke upper limb~     spasticity measured by the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke.~   "
199970|NCT00945282|"~     GSK has in-licensed a novel NNRTI-class candidate (GSK2248761, IDX12899) for the treatment of~     subjects with HIV-1 infection from Idenix Pharmaceuticals. Idenix Pharmaceuticals completed a~     proof-of-concept study evaluating GSK2248761 monotherapy over seven days in forty~     treatment-naïve subjects infected with HIV-1. GSK2248761 doses sequentially evaluated were~     800 mg QD, 400 mg QD, 200 mg QD and 100mg QD.~      This study will evaluate a lower dose, or doses, of GSK2248761 to better characterize the~     dose-response and concentration-response curves. The results from this study will be used to~     select doses for future clinical studies in HIV-1 infected subjects.~   "
199971|NCT00945269|"~     RATIONALE: White blood cells that have been treated in a laboratory may be able to kill tumor~     cells in patients with melanoma. Aldesleukin and denileukin diftitox may stimulate the white~     blood cells to kill melanoma cells. Giving therapeutic autologous lymphocyte therapy together~     with aldesleukin and denileukin diftitox may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving therapeutic autologous~     lymphocytes together with aldesleukin and denileukin diftitox and to see how well it works in~     treating patients with stage III-IV melanoma~   "
200015|NCT00944697|"~     To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of~     pregabalin compared to pregabalin alone.~   "
199972|NCT00945256|"~     The purpose of this study was to examine the role skeletal muscle perfusion plays in~     mediating muscle protein synthesis in healthy older and younger individuals. The~     investigators hypothesized that normalization of muscle perfusion in older men and women via~     exercise or infusion of a vasodilator would enhance nutritive flow and skeletal muscle~     protein synthesis in the elderly similar to that of their younger counterparts.~   "
199973|NCT00945243|"~     This is a multi-center, prospective, outcomes study. In this study, the Zero-P PEEK implant~     will be used in patients undergoing ACDF for treatment of SCDD at a single level between C3~     and C7. The cohort will be followed over time to twenty-four (24) months after surgery. Up to~     fifteen (15) sites will participate in this study. This is not a controlled study.~   "
199974|NCT00945230|"~     The study examines and illustrates the utility of utilizing actigraphic measurements to~     assess treatment response.~   "
199975|NCT00945217|"~     Atherogenic dyslipidemia is characterized by high levels of apolipoprotein B~     (apoB)-containing lipoproteins, including very-low-density lipoprotein (VLDL) and its~     remnants and small, dense LDL (sdLDL) particles, and reduced levels of high-density~     lipoprotein cholesterol (HDL-C). The National Cholesterol Education Program (NCEP)~     recommended using non-high-density lipoprotein cholesterol (non-HDL-C) to surrogate~     atherogenic lipoproteins in clinical practice. Recently, the investigators have done a pilot~     study to study the associations between SAH gene variants and atherogenic dyslipidemia~     (surrogated by non-HDL-C) in postmenopausal women. The investigators found that homozygosity~     for SAH haplotype 3 was associated with increased adiposity, insulin resistance, and elevated~     levels of non-HDL-C in the postmenopausal women. Based on the findings of the pilot study,~     the investigators plan to expand the cohort of postmenopausal women to about 800 women, that~     is, recruited 660 new subjects in two years. The associations between non-HDL-C and the SAH~     gene family will be done. Fasting blood sampling for buffy coats and lipids is the core test~     of Study 2. A 75-g oral glucose tolerance test (OGTT) will be available as an optional test~     for a better phenotyping of insulin resistance for the participants. Detailed lipid profiling~     including measurements of VLDL cholesterol, VLDL-TG, remnant lipoprotein, LDL particle size,~     apoA1, apoB, and apoCIII will be done in the second year of the study if significant~     associations between gene variants of the SAH gene family and non-HDL-C are detected.~   "
199976|NCT00945204|"~     The aim of this trial is to assess the effectiveness of intermediate care clinics for~     diabetes, compared to usual care.~   "
199977|NCT00945191|"~     This is a trial to see what effects a combination therapy with CS-1008 and~     Paclitaxel/Carboplatin will have on a patient's response in locally advanced or metastatic~     ovarian cancer.~   "
199978|NCT00945178|"~     The study will investigate how a new formulation of the study drug is absorbed, metabolised~     and distributed through the body, as well as its safety and tolerability in higher doses when~     given as single and multiple doses and as a single dose in the presence and absence of~     naproxen.~   "
199979|NCT00945165|"~     Hyperglycemia is an independent risk factor for the development of diabetic complications in~     type 2 diabetes. Exercise improves glycemic control, however, the role of exercise~     characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be~     elucidated.~      This study aims to assess the effect of several exercise characteristics on hyperglycemia in~     various subgroups of type 2 diabetes patiënts.~   "
199980|NCT00945152|"~     Based on personal experience and the literature it is reasonable expectation that Vancomycin~     is a viable treatment in a direct contact form to eliminate MRSA from open wounds in order to~     heal the wounds by conventional means. The key question in my research has been to measure~     the effectiveness of my Vancomycin Gel by culturing the wound, applying the Gel in a~     controlled manner and then culturing the wound after one week. The end point to achieve in~     the process, is a clinical response of accelerated healing and negative culture report.~     Another question to solve is the duration of potency and stability of the Vancomycin gel over~     time.~   "
199981|NCT00945139|"~     The purpose of this research study is to test the safety, tolerability, and effectiveness of~     two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin).~     How Doxil is metabolized and excreted from the body will also be studied.~   "
199982|NCT00945126|"~     The aim of the study is to investigate the feasibility and toxicity of allogeneic~     haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with~     a reduced or a standard conditioning regimen in pediatric patients with malignant and~     non-malignant high-risk diseases, for whom allogeneic stem cell transplantation represents~     the only possible therapy option and no human leukocyte antigen (HLA) compatible related~     donors are available.~   "
199983|NCT00945113|"~     The aim of the study is to answer the question: Is a large-scale research study of the~     effectiveness of group speech and language therapy (SALT) for young people who stammer~     possible?~      The study will look at the issues involved in setting up a large-scale investigation of~     treatment for young people who stammer. It will inform the investigators whether larger~     studies would be possible and give some early-stage information on the effectiveness of group~     SALT for these young people. The findings will pave the way for building and testing out~     treatment programmes where there will be clear positive benefit for young people who stammer~     and their families.~      To answer the research question, the study will tell the investigators (a) how easy/difficult~     it was to get people to take part, (b) young people and parents'/carers' views on taking part~     and (c) whether the assessments were able to pick up changes in speech and attitudes towards~     stammering reported by the young people and their carers.~      Sufficient numbers of participants were not recruited to carry out the intended rehearsal~     pilot RCT study design.~   "
199984|NCT00945100|"~     This study is designed to evaluate the effectiveness of increasing prescribed patching~     treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment~     and amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to~     20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching~     until no improvement, followed by randomization of eligible patients to patching 2 hours~     daily versus an average of 6 hours daily (42 hours per week). The primary objective is to~     determine if increasing patching dosage will improve visual acuity in patients with amblyopia~     still present after visual acuity has stabilized with initial treatment.~   "
202599|NCT00910533|"~     The purpose of this study is to determine clinical course and the sequelae of early Lyme~     neuroborreliosis after treatment with ceftriaxone.~   "
199985|NCT00945087|"~     The primary purpose of this experimental therapy is to treat, with the aid of bacteriophages,~     patients with non-healing postoperative wounds or bone, upper respiratory tract, genital or~     urinary tract infections in whom extensive antibiotic therapy failed or the use of the~     targeted drug is contraindicated.~   "
199986|NCT00945074|"~     The objective of this study is to test the efficacy of a symptom management treatment~     strategy, namely, Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with~     Irritable Bowel Syndrome (IBS) in persons between the ages of 18 to 70 years.~      IBS has been defined as abdominal pain or discomfort in the mid or lower gastrointestinal~     (GI) tract, associated with defecation or a change in bowel patterns and with features of~     disordered defecation. Current therapies include dietary modification, psychotherapy and~     pharmacological therapies. Traditional eastern approaches offer a therapeutic approach to~     symptom management that is subtle, holistic and holds promise as an intervention for IBS.~      This study will enroll 171 men and women experiencing IBS with diarrhea (IBS-D) defined by~     the ROME III criteria. Subjects will be randomized (by chance) to one of three experimental~     intervention conditions: Condition 1,subjects receive Standard Acu/Moxa; Condition 2,~     subjects receive Individualized Acu/Moxa and Condition 3, subjects receive Sham~     Acupuncture/Placebo Moxibustion(control group).~      Subjects will attend a screening/intake session followed by two treatment sessions per week~     for 4 weeks, one treatment session per week for 4 weeks, and 2 non-treatment follow-up~     sessions at weeks 12 and 24. All subjects will be assessed by a diagnostic acupuncturist~     (blinded to treatment assignments), receive interventions appropriate to their condition~     assignment by treating acupuncturists, be administered the same instruments, and submit their~     symptom diaries for data entry and analysis. All subjects will complete a prospective symptom~     diary for the duration of the study.~   "
199987|NCT00945061|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. It is not yet known whether a single dose of radiation therapy is more effective~     than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.~      PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works~     compared with radiation therapy during surgery in treating patients with recurrent breast~     cancer.~   "
199988|NCT00945048|"~     The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac~     diseases. The current standard methods for the determination of the CO, however, are either~     invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic~     resonance tomography, MRT). Therefore the aim of the study at hand was to evaluate the~     electrical velocimetry technique as a new method for determining the CO and to compare this~     new technique with the Inert Gas Rebreathing Method and with the Magnetic Resonance~     Tomography~   "
199989|NCT00945035|"~     This study will establish the bioequivalence of the 20%, milled, roller compaction final~     market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib~     tablets.~   "
199990|NCT00945022|"~     Following waking up from surgery performed under general anesthesia, patients are suffering~     from discomforting oral dryness, and moreover, they are not allowed drinking for 24 hours.~     The current management involves the wetting of patient's lips using wet bandage. This action~     is dependent on the presence of a family member or a nurse, which is not always possible.~     Many patients describe the oral dryness as a suffering, added to the suffering anyway~     entailed by surgery.~      The investigated Lipsus device is intended for oral wetting, relieving patient's suffering~     and minimizing the dependence on continuous presence next to patient's bed.~   "
199991|NCT00945009|"~     This phase III clinical trial is studying how well combination chemotherapy and surgery work~     in treating young patients with Bilateral Wilms tumor and children who are a special risk for~     forming tumors in both kidneys. Drugs used in chemotherapy work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination~     chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed. Giving it after surgery may kill any tumor cells that remain after~     surgery.~   "
199992|NCT00944996|"~     The neuropeptide Pituitary Adenylate Cyclase Activating Polypeptide (PACAP) and its receptors~     PAC1 and VPAC2 are widely expressed in the nervous system. The investigators found that PACAP~     treatment of neuronal cell cultures increases expression of Brain Derived Neurotrophic Factor~     (BDNF) that plays an important role in the etiology of psychiatric disorders and action of~     antidepressants. For the first time, the investigators demonstrated that treatment by~     Paroxetine and Citalopram significantly decreases PAC1 and VPAC2 and upregulates PACAP mRNA~     expression, whereas Imipramine shows an opposite effect. Moreover, PACAP, PAC1 and VPAC2~     expression is highly correlated with BDNF expression. Their in vivo studies show that~     Imipramine reduces BDNF and increases PAC1 mRNA expression in murine hippocampus, suggesting~     that antidepressants may affect neuronal plasticity through PACAP-BDNF interactions. Based on~     their observations in experimental systems, the investigators hypothesize that PACAP~     signaling system may be involved in the etiology of depression and mechanism of~     antidepressant action. The investigators will evaluate this hypothesis by examining serum~     PACAP levels, effect of antidepressants on PACAP levels, and gene polymorphisms of PACAP and~     its receptors in major depressive disorder patients. This study will enhance the~     investigators' understanding of PACAP's role in the etiology of depression and antidepressant~     treatment and will provide a basis to evaluate PACAP pathway as a potential target for~     diagnostics and novel antidepressants drug discovery.~   "
199993|NCT00944983|"~     Clinical validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitoring~     system according to the accuracy guidelines of the ISO 80601-2-30 Standard in Adults,~     Adolescents, and Children.~   "
199994|NCT00944970|"~     Binodenoson (an experimental drug) and adenosine (an FDA-approved drug that is currently used~     by doctors) are used to increase blood flow to the heart just like when a person exercises on~     a treadmill. Using imaging techniques, this increased blood flow can help determine if areas~     of the heart are not getting enough blood and oxygen during exercise. The purpose of the~     study is to determine if binodenoson is as good as adenosine in determining if there are~     areas of the heart not getting enough oxygen when blood flow to the heart is increased.~   "
200595|NCT00937079|"~     The purpose of this study is to determine whether the investigators' new imaging modality~     (111In-exendin-4) has advantages in detecting insulinomas in comparison to conventional~     imaging.~   "
199995|NCT00944957|"~     Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams,~     dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of~     treatment, with subsequent attenuation but may not completely resolve even years after~     efavirenz initiation.~      The investigators plan a four week, randomized, placebo-controlled, double-blind study. In~     group 1, efavirenz will be replaced with efavirenz placebo plus raltegravir, in group 2,~     efavirenz would be continued, and raltegravir placebo given in addition. After two weeks,~     patients in group 1 would switch to the regimen of group 2, and vice versa.~      The primary endpoint of the trial will be patient preference. Sleep quality, daytime~     sleepiness, and anxiety will also be investigated.~   "
199996|NCT00944944|"~     The purpose of this study is to evaluate if the Gynecologic Cancer Lymphedema Questionnaire~     (GCLQ) truly detects symptoms or signs of lower extremity lymphedema in patients with~     diagnosed lower extremity lymphedema. Lymphedema is a chronic condition in which fluid~     accumulates in the tissues of the body. Many cancer survivors are living with discomfort and~     changes in their activities due to limb swelling following cancer treatment. If the GCLQ is~     able to do detect signs and symptoms of lymphedema, the investigators hope to use it as a~     tool in the clinical care setting to help identify women at risk for or with lymphedema. In~     the future, this could improve clinical care through the use of a more simple and feasible~     way to identify lower extremity lymphedema than measuring limbs.~   "
199997|NCT00944931|"~     Background:~        -  Direct current (DC) brain polarization is a technique in which very weak electricity is~          applied to the head. Doctors have used DC polarization for many years on patients and~          healthy people with no known serious side effects. Earlier, researchers found that DC~          polarization can temporarily improve the ability of healthy people to think of certain~          words.~        -  A disadvantage of existing methods of DC polarization is that they use large electrodes~          and the current spreads over a large area of the brain. This makes it difficult to~          target particular brain areas. High-density DC polarization uses several small~          electrodes to focus the current in a small area of the brain. This study will test~          high-density DC polarization for the first time in humans.~      Objectives:~        -  To see how well high-density direct current polarization works in the brain.~        -  To test a new method of performing direct current brain polarization.~      Eligibility:~      - Healthy, right-handed adults, ages 18 and older, who have no history of neurological or~     psychiatric illnesses.~      Design:~        -  After an initial screening visit with clinical examination, participants may be assigned~          to one or both experiments of the study.~        -  Experiment 1: Participants will have electrodes placed on the left side of their heads,~          and will be asked to say aloud as many words as they can think of that begin with~          certain letters. After the high-density DC polarization current is turned on and run for~          10 minutes, participants will say words beginning with a different set of letters and~          perform reaction time and thinking speed tests. Some participants will receive real~          polarization and others will not, although all participants will be told that they are~          receiving the polarization.~        -  Experiment 2: Participants will have DC brain polarization performed with transcranial~          magnetic stimulation (TMS), which uses magnetic pulses to activate nerve cells in the~          brain. We will use TMS to help us understand how far the effect of DC polarization~          spreads in the brain. After attaching electrodes to a point on the scalp above the ear,~          researchers will give about 50 TMS pulses to five different places near this area. These~          pulses will produce some painless muscle twitches in the hand or arm. The TMS pulses~          will be followed by the DC brain polarization, and then by another set of TMS pulses to~          see if there are any differences in muscle response.~   "
199998|NCT00944918|"~     A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant~     Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally~     advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to~     Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex~     treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.~   "
199999|NCT00944905|"~     The purpose of this study is to determine if MDX-1203 is safe for the treatment of renal cell~     carcinoma or non-hodgkin's lymphoma.~   "
200000|NCT00944892|"~     This is a double-blind, prospective, randomized study in which patients will be randomized to~     1 of 4 treatment arms (3 active and 1 placebo).~      Each patient will receive two doses of active medication or placebo, with study drug~     administered intravenously (IV). The primary goal of the study is to assess the safety and~     tolerability of repeat administrations of REGN475 compared to placebo in patients with~     osteoarthritis (OA) of the knee.~   "
200001|NCT00944879|"~     This study will use the licensed HPV vaccine, Gardasil, as a surrogate for an HIV vaccine, in~     order to explore some of the ethico-legal,psycho-social and logistical challenges involved in~     running an HIV vaccine trial in adolescents.~   "
200002|NCT00944866|"~     The selective cyclooxygenase-2 (COX-2) inhibitors have been associated with increased~     cardiovascular risk. The goal of the present study is to investigate the impacts of COX-2~     inhibitors on biochemical indices in cardiovascular disease. As the reviewer suggested, the~     investigators propose to study the effects of Cox-II inhibitor using experimentally induced~     hyperlipidemic rats. Plasma total cholesterol, LDL and triglyceride concentrations will be~     determined before and after animals treated with cyclooxygenase-2 (COX-2) inhibitors.~     Biochemical markers related to cardiovascular events including prostaglandin I2,~     thromboxaneA2 and others will also be investigated. The investigators will also investigate~     these biochemical markers in patients taking Celecoxib and NSAIDs. The investigators hope~     these studies will reveal clinically useful biochemical markers for cardiovascular events in~     patients taking Cox-II inhibitor.~   "
200003|NCT00944853|"~     The study aims to compare the effects of two different formulations of zinc supplements on~     plasma zinc concentrations among young Burkinabe children.~   "
200004|NCT00944840|"~     Malaria in African countries remains an important cause of mortality and morbidity among~     young children. The global malaria control strategies include prompt treatment with an~     effective antimalarial drug, vector control using ITNs or curtains, indoor residual spraying~     (IRS), and intermittent preventive treatment. However, individually these interventions~     provide only imperfect protection. Thus, there is a need to investigate whether additional~     control measures provide added benefit in reducing mortality and morbidity. Therefore, 1312~     children under 5 years of age living in villages and hamlets near Farafenni, The Gambia,~     which form part of the rural Farafenni Demographic Surveillance system (FDSS) in North Bank~     Region(NBR) were randomly allocated to receive IPTc or placebo from village health workers~     based in primary health care villages. Treatment with a single dose of sulfadoxine~     /pyrimethamine plus three doses of amodiaquine or placebo was given to all study subjects at~     monthly intervals on three occasions during the months of September, October and November. In~     addition, VHWs were trained to administer treatment with coartem to children if they develop~     symptoms compatible with malaria during the malaria transmission season. The primary end~     point was the incidence of clinical attacks of malaria detected during the study.~   "
200342|NCT00940394|"~     The mutual support group intervention would significantly improve the families' burden of~     care, functioning and social support, reduce the patients' severity of symptoms and~     re-hospitalizations, and reduce the demands for utilization of family services, when compared~     with the standard care group.~   "
200005|NCT00944827|"~     There is a positive correlation between serum's cholesterol levels and death from~     cardiovascular disease, especially coronary artery disease. The reduction of plasma lipids~     levels is one of the main goals of prevention. Research has shown that green tea has~     beneficial effects on health due to the polyphenolic substances (catechins) that it contains.~     Studies have shown that prolonged consumption of polyphenols has a positive effect on factors~     related to cardiovascular risk such as obesity, dislipidemia and various indicators of~     oxidative stress.~      The aim of this study was to examine the possible effects of catechin supplementation, in~     combination with the classic treatment for the reduction of hypercholesterolemia, statin~     therapy, on the treatment's effectiveness and in the reduction of classic side effects.~   "
200006|NCT00944814|"~     The purpose of the study is to assess the acceptability of the two lipid-based nutrient~     supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g~     dose of LNS). The hypothesis is that both products will be equally accepted by children and~     mothers.~   "
200007|NCT00944801|"~     Glioblastomas represent 40% of all tumors of the central nervous system (CNS) and are among~     the most lethal tumors. Temozolomide (TMZ) combined with radiotherapy was the first substance~     to significantly improve the overall survival (to 14.6 months) as compared to surgery and~     radiotherapy alone and increased the proportion of patients surviving more than 2 years to~     26%. TMZ showed the best efficacy in patients with a methylated O6-methylguanine-DNA~     methyltransferase (MGMT) promoter in part by eliminating stem cell-like tumor cells. Among~     patients with a methylated MGMT promoter, the median survival after treatment with combined~     radio-chemotherapy was 21.7 months, as compared to 15.3 months among those who were assigned~     to radiotherapy only. In the absence of methylation of the MGMT promoter, there was a smaller~     and statistically insignificant difference in survival between the treatment groups.~      Doxorubicin is one of the most effective substances in vitro against cells derived from~     glioblastoma. However, it has no significant effect in vivo due to poor blood-brain-barrier~     penetration. In a tumor model, tissue and CSF-concentrations of doxorubicin were~     substantially increased when sterically stabilized liposomes were used resulting in a~     comparable clinical response using approximately half of the dose of stabilized liposomes~     compared to conventional doxorubicin. A pegylated formulation (PEG-liposomal Doxorubicin)~     even further improved the penetration of the blood-brain barrier. Case series and two phase~     II-studies in patients with recurrent glioblastoma have shown modestly promising results for~     PEG-Dox.~      In this study, the investigators treated patients with recurrent glioblastoma with 20 mg/m2~     PEG-Dox on days 1 and 15 of each 28-day cycle. To determine the dose limiting toxicity of~     PEG-Dox combined with prolonged administration of TMZ, the investigators performed a phase I~     part ahead of the phase II study. To investigate, by means of a historical control analysis,~     if the addition of PEG-Dox to TMZ and radiotherapy improves the survival of patients, the~     investigators chose similar inclusion criteria and identical TMZ and radiotherapeutic regimes~     as in the EORTC26981/NCIC-CE.3 study.~   "
200008|NCT00944788|"~     The purpose of this study is to test the effects on a number of health outcomes and the~     feasibility of a structured program of qi-gong, a form of tai-chi which has been previously~     tested in older populations, in older hospitalized patients. In particular, this pilot study~     aims to assess changes in quality of life and depressive symptoms after 4 weeks of treatment,~     with the hypothesis that this intervention will have a positive impact on these two domains,~     compared to usual care. Adherence will be also monitored in the intervention arm.~   "
200009|NCT00944775|"~     Background: The impact of the known non-invasive cardiac indices for identification of~     hemodialysis (HD) patients at high-risk for sudden cardiac death (SCD) has not been~     evaluated.~      Patients: Fifty-nine HD patients were randomized into 2 groups. Thirty of them (group A-aged~     54.6±8.9 years) participated in a supervised training program with stationary bicycles during~     their HD sessions (3/weekly) for 10 months, while the rest (group B-aged 53.2±6.1 years)~     remained untrained and were used as controls.~      Study hypothesis: Exercise training will affect most of the non-invasive cardiac markers of~     SCD and the total score positively.~      Method: At entry, as well as at the end of the study all subjects underwent a cardiopulmonary~     exercise testing (estimation of aerobic capacity-VO2peak), an echocardiographic study (LV~     ejection fraction -LVEF evaluation), an ambulatory 24-hour Holter monitoring for cardiac~     autonomic nervous system activity evaluation by time- and frequency- domain heart rate~     variability (HRV) calculation (measurement of SDNN, mean RR and low to high frequency~     ratio-LF/HF), a signal-averaged ECG (late potentials-LP documentation) and a submaximal~     exercise test for microvolt-T-wave alternans (TWA) detection.~   "
200010|NCT00944762|"~     This study will determine the effectiveness of a specialized psychotherapy for treating~     elderly stroke survivors who are depressed.~   "
200011|NCT00944749|"~     Background:~        -  Severe plastic anemia can lead to problems with bone marrow platelet production and~          result in low blood platelet counts, which require frequent platelet transfusions to~          improve blood clotting.~        -  A standard treatment for SAA involves injections of rabbit-antithymocyte globulin~          (r-ATG). r-ATG is developed by injecting horses with a type of human white blood cells~          called thymocytes. The horse's immune system reacts against these cells and makes~          antibodies that can destroy them. These antibodies are collected and purified to make~          r-ATG. Horses can also be used for this procedure to make horse-antithymocyte globulin~          (h-ATG).~        -  h-ATG is approved by the Food and Drug Administration for the treatment of aplastic~          anemia. h-ATG is a standard first-line method to treat aplastic anemia, but researchers~          do not know how effective it is in patients who were first treated unsuccessfully with~          r-ATG.~      Objectives:~      - To evaluate the effectiveness and safety of horse-ATG (with cyclosporine) in increasing~     blood counts and reducing the need for transfusions in aplastic anemia patients who have~     failed to respond to prior immunosuppressive treatment with rabbit-ATG and cyclosporine.~      Eligibility:~      - Patients 2 years of age and older who have consistently low blood platelet counts related~     to aplastic anemia that has not responded to conventional treatment with rabbit-ATG.~      Design:~        -  After initial screening, medical history, and blood tests, patients will be admitted to~          the inpatient unit at the National Institutes of Health Clinical Center. Researchers~          will perform a skin test with h-ATG to check for allergic or other adverse reaction.~        -  After the skin test, h-ATG will be given into a vein continuously over 4 days.~        -  Cyclosporine will also be given to improve the response rate of ATG treatment. Treatment~          with cyclosporine will start the same day as the h-ATG, either in liquid or capsule~          form, and continued for 6 months. The dose of cyclosporine will be monitored and~          adjusted based on blood levels and signs of side effects in the kidney and liver.~        -  To prevent or treat infections that may result from cyclosporine s effect on the immune~          system, patients will also take inhaled or capsule doses of pentamidine.~        -  After the study is completed, patients will have followup evaluations every 3 months, 6~          months, and annually for 5 years. Evaluations will include blood samples and periodic~          bone marrow biopsies.~   "
200012|NCT00944736|"~     The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on~     intestinal permeability in pediatric patients with Crohn's disease.~   "
200013|NCT00944723|"~     The purpose of the study is to evaluate the use of plasma zinc concentration for assessing~     the impact of mass zinc fortification programs.~   "
200014|NCT00944710|"~     This study is designed to evaluate the effectiveness of adding a plano lens to weekend~     atropine after visual acuity has stabilized with weekend atropine but amblyopia is still~     present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic~     eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed~     by randomization of eligible patients to weekend atropine treatment with a plano lens over~     the sound eye versus without a plano lens over the sound eye. The primary objective is to~     determine if adding a plano lens to weekend atropine will improve visual acuity in patients~     with amblyopia still present after visual acuity has stabilized with initial treatment.~   "
200016|NCT00944684|"~     Treatment of patients with chronic hepatitis C infected with genotype 1 hepatitis C virus~     (HCV) consists of combined peginterferon/ribavirin for 48 weeks. Approximately 50% of~     patients experience sustained virological response which equals cure. All other patients~     either do not respond or experience recurrence of HCV virus and chronic hepatitis. Important~     predictors of successful treatment are sustained dosing of both peginterferon and ribavirin.~     With regard to the latter, clinical evidence indicates that higher ribavirin doses may in~     fact even improve treatment outcome. However, high ribavirin doses cause hemolytic anemia~     which require dose reductions. Recent clinical experience show that erythropoetic growth~     factors, including erythropoetin, can counteract hemolytic anemia caused by antiviral~     treatment in chronic hepatitis C patients. Therefore, the current trial aims to test whether~     higher ribavirin doses adapted to a target plasma concentrations instead of a weight-based~     dosing result in better healing rates, and whether ribavirin-associated hemolytic anemia can~     be compensated by concommitant erythropoetin treatment.~      Using a randomized, controlled, open-label design, the investigators hypothesize that~     patients with high ribavirin doses adapted to plasma levels experience better viral clearance~     than patients treated with standard weight-based ribavirin doses. In addition, the~     investigators hypothesize that erythropoetin treatment will counteract hemolytic anemia~     induced by ribavirin thereby allowing maintenance of target plasma concentrations without~     ribavirin dose reductions.~   "
200017|NCT00944671|"~     A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew~     tablet taken without water and with water compared to the Famotidine/Antacid tablet taken~     with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.~   "
200018|NCT00944658|"~     Presently, there are very few treatments available which affect the progression of the~     disease in the spine. The only proven treatment is the use of drugs inhibiting tumour~     necrosis factor alpha (TNF). However, there are limitations with this treatment in that it~     needs to be administered via an injection and is also very expensive. Therefore it is~     necessary to develop new therapeutic agents for this condition.~      Apremilast (the study drug) is an oral tablet which has been shown to inhibit TNF production~     in a mouse model of inflammation. It has also been used in clinical trials for asthma and~     psoriasis in humans with good affect and tolerability.~      These studies were funded by Celgene Corporation and they will be funding this study.~      This study will evaluate the effectiveness of apremilast in AS as measured by improvement in~     patients' signs and symptoms of the disease and changes in imaging. Additionally the safety~     and tolerability of apremilast in AS will be assessed. The patients will be recruited from~     hospitals by Consultant referral. The patients will have had AS for at least 2 years and~     their symptoms will have been uncontrolled on conventional non−steroidal anti−inflammatory~     drugs such as ibuprofen. Patients will be randomised to either receive apremilast or a~     placebo and treated over a period of 12 weeks. They will then be followed up for 28 days~     after the treatment period.~   "
200019|NCT00944645|"~     This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg~     Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.~   "
200020|NCT00944632|"~     The purpose of this study is to determine the safety and efficacy of three concentrations of~     ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic~     dermatitis and to obtain dose-response information for the three concentrations.~   "
200021|NCT00944619|"~     The main objective is to assess the efficacy and safety of overnight automated closed loop~     glucose control using a computer-based algorithm compared with conventional insulin pump~     therapy in adults with type 1 diabetes following the consumption of a moderate amount of~     alcohol at dinnertime.~   "
200022|NCT00944606|"~     Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain.~      Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal~     pain in children.~   "
200023|NCT00944593|"~     Diabetic 'Gastroparesis' or 'Gastroenteropathy' is a condition in which patients suffer~     episodes of nausea, vomiting, abdominal bloating and pain after eating. These symptoms occur~     in the absence of any structural abnormality of the stomach, rather abnormal gastric function~     underlies the condition. Up to one in five patients with type I diabetes experience symptoms~     consistent with this diagnosis. The effects on diabetic control, physical health and~     emotional quality of life are severe. Patients do not respond reliably to general supportive~     management or conventional medications. Surgical options have disappointing results. The need~     for more effective treatment is acknowledged universally.~      Feeding into the small bowel beyond the stomach (jejunal feeding) is established management~     in diabetic patients with gastroenteropathy that are malnourished due to poor oral intake.~     The benefits have been assumed secondary to improved nutrition and diabetic control; however~     this assertion has never been studied. Recently we observed that patients with severe~     gastroenteropathy recovered promptly and could eat normally during and for a few hours after~     jejunal feeding. These observations suggest that jejunal feeding has 'quasi-pharmacological'~     effects in patients with gastroenteropathy. One attractive explanation for these observations~     is that gastroenteropathy represents a failure of oral intake to 'switch' the stomach from~     the fasted to the fed state. According to this hypothesis, jejunal feeding 'restores' the~     normal fed state by bypassing the dysfunctional stomach.~      This project will assess the effects of feeding on gastrointestinal (GI) sensory and motor~     function in diabetic gastroenteropathy. Healthy volunteers and diabetic controls without~     symptoms will also be investigated. Studies will assess:~        1. Effects on GI symptoms and function to gastric distension in fasted and fed states~        2. Effects on GI symptoms and function to oral vs. nasogastric delivery of a test meal~        3. A trial of gastric feeding with and without prior jejunal feeding on GI symptoms and~          function Non-invasive magnetic resonance imaging (MRI) techniques will be applied to~          assess complex gastric response to feeding. In addition the effects of feeding on~          symptoms and gastric function will be related to alterations in GI hormones and~          autonomic nervous activity (eg cardiovagal tone) to assess how the integrated response~          of the GI tract to feeding fails in patients with diabetic gastroenteropathy.~      The primary aim of this project is to assess the effectiveness of jejunal feeding in the~     management of diabetic gastroenteropathy. However, by defining the processes that 'switch'~     gastric function between the fasted and the fed states and control gastric emptying, we hope~     also to identify candidate targets for more effective pharmacologic treatment of this severe~     disease.~        -  Trial with medical device~   "
200024|NCT00944580|"~     The purpose of this study is to determine the safety and immunological effects of a vaccine~     for people diagnosed with high risk neuroblastoma, osteogenic sarcoma, and rhabdomyosarcoma.~     It is hypothesized that this vaccine could reduce the incidence of relapse.~   "
200025|NCT00944567|"~     A non-profit study designed with the aim of analysing the phenotype and molecular~     characteristics (central review) and evaluating prospectively the role of PET-scans in the~     management of primary mediastinal lymphoma treated with conventional approaches.~   "
200026|NCT00944554|"~     This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation~     aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the~     laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking~     and will delay or prevent relapse compared to placebo.~   "
200343|NCT00940381|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of sirolimus and cetuximab that can be given to patients with advanced cancer.~     The safety of this drug combination will also be studied.~   "
200027|NCT00944541|"~     This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV~     infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6~     months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL~     during last 24 months).~      The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment~     period will be maintained for 12 months.~   "
200028|NCT00944528|"~     This study seeks to determine the maximum tolerated dose of a single-dose partial breast~     radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be~     performed within 3 weeks (+/- 1 week) of completing radiation.~   "
200029|NCT00944515|"~     The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing~     recurrent acute sinusitis in children.~   "
200030|NCT00944502|"~     To evaluate the efficacy and tolerability of Vitatonus Dexa compared with dexamethasone in~     the signs and symptoms of neuralgia of various origins.~      Clinical study, randomized prospective and random in nature, with a patients diagnosed with~     neuralgia of diverse origin.~      Patients will be include in sufficient quantity to achieve the minimum of 104 evaluable~     patients.~   "
200031|NCT00944489|"~     The main goal of this study is to achieve a deeper knowledge of the adherence to~     antihypertensive drug treatment and to evaluate the quality of life in this population. This~     work has the following goals: primary objective is to assess the antihypertensive treatment~     adherence in patients with essential hypertension on treatment for more than 6 months.~      The secondary objectives include the assessment of quality of life, identification of~     associated factors that affect adherence, knowledge of drugs used and comparison of levels of~     adherence according to the different drug regimes~      Two questionnaires shall be prepared The first questionnaire shall be anonymously completed~     by the patient willing to participate. It is divided into two parts:~        1. Treatment Adherence Scale (MMAS): this survey is made up of 4 questions having YES/No~          answers and it grants 1 point per every NO answer, and zero points to every YES~          answer.~        2. The second part is the health-related quality of life Questionnaire (MINICHAL). The~          questions refer to the last 7 days with 4 possible answer options: 0 (no, absolutely~          not), 1 (yes, sometimes), 2 (yes, frequently) and 3 (yes, a lot). It is made up of 16~          items, 10 correspond to the State of Mind dimension and 6 to the Body-related~          Symptoms, also described as Physical symptoms.~      The second questionnaire shall be completed by the intervening physician as regards patients~     that attend medical visits, and who have answered the anonymous questionnaire.~   "
200032|NCT00944476|"~     Magnetic resonance imaging (MRI) is presently the best study for assessing the size and~     extent of the patient's sarcoma. Many sarcomas contain fat that can interfere with the~     accuracy of sarcoma detection. The investigators have developed a new MRI method that can~     suppress all the fat signals in the patient's tumor and this may improve the investigators'~     ability to see the patient's sarcoma. The purpose of this study is to determine if the~     investigators' new fat-free imaging methods provides them with images that are better than,~     equal to, or worse than those images obtained by standard MRI methods. This study may help~     the investigators develop a more accurate MRI examination.~   "
200033|NCT00944463|"~     The purpose of this study is to determine whether simvastatin is effective in the treatment~     of advanced pancreatic cancer patients.~   "
200034|NCT00944450|"~     This study will establish that the MK0431 100 mg anhydrous formulation tablets are~     bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.~   "
200035|NCT00944437|"~     The aim of this study is to compare two methods of delivery of noninvasive mechanical~     ventilation (NIV).~      Since patient compliance and mechanical characteristics of the delivery devices are two~     fundamental variables in the success of NIV during acute respiratory failure, our hypothesis~     is that an improved patient-ventilator interface may improve the efficacy of therapy.~   "
200036|NCT00944424|"~     Randomized phase III trial to determine the effectiveness of High dose versus Standard dose~     of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer~   "
200037|NCT00944398|"~     The purpose of the study is to evaluate the use of plasma zinc concentration for assessing~     the impact of targeted zinc fortification programs.~   "
200038|NCT00944385|"~     According to TEG (thromboelastography), as maximum amplitude is increased the amount of~     bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin.~   "
200039|NCT00944372|"~     The objective of this study was to evaluate the effect of age (geriatric) and renal function~     on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose~     in this patient population.~   "
200040|NCT00944359|"~     Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency~     or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to~     determine how best to integrate programs designed either to prevent zinc deficiency or to~     treat diarrhea.~      The overall objective of this project is to determine the most effective approach to prevent~     zinc deficiency and treat diarrhea, such that a single approach could provide the maximal~     beneficial impact on the health and nutritional status of young children and greatest~     simplicity of implementation.~   "
200041|NCT00944346|"~     -  Objective:~             -  A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the~               Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to~               an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®,~               Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.~        -  Study Design:~             -  Randomized,single-dose,2-way crossover.~   "
200062|NCT00944073|"~     The purpose of this study is to assess the safety and the body's immune response (body's~     defense against disease) to an experimental H1N1 influenza vaccine. Up to 650 healthy~     volunteers from three age groups (greater than or equal to 6 months to less than 36 months,~     greater than or equal to 36 months to 9 years, and 10 - 17 years) with no history of~     influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination will participate.~     Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups.~     Group 1 will receive 15 mcg of vaccine; Group 2 will receive 30 mcg of vaccine. Participants~     will receive vaccine injections on Days 0 and 21 in the arm or thigh muscle. Study procedures~     include: medical history, physical exam, maintaining a memory aid, and blood sample~     collection. Participants will be involved in study related procedures for approximately 7~     months.~   "
200042|NCT00944333|"~     Prospective, randomized, non-inferiority, multicenter, international study.In total 4000~     patients (70 centers in Europe) with de novo lesions in native coronary arteries who meet the~     eligibility criteria randomized to 6 versus 12 month dual antiplatelet therapies following a~     second generation DES implantation.~      Assuming that the true proportion of thrombotic events is equal to 2.3% for both regimens~     (6-month and 12-month clopidogrel) 2000 patients for each treatment group are necessary to~     demonstrate a non-inferiority of the 6-months regimen if the proportion of thrombotic events~     will be no more than 3.5% with a power of 0.80 and a significance level of 0.05 (one-tail).~      If the non-inferiority hypothesis will be rejected, the superiority hypothesis (12-months~     regimen is superior to the 6-months-regimen) will be tested at a significance level of 0.05~     (two-tails).~      The maximal not clinically relevant difference for the non-inferiority hypothesis of 1.2 %~     more thrombotic events has to be considered together with the lower expected number of~     bleeding events in the 6-months regimen.~      All the analysis will be done as intention-to-treat analysis.~   "
200043|NCT00944320|"~     Polymorphisms occur in several genes encoding key enzymes in the folate pathway may affect~     drug metabolism in patients with rheumatoid arthritis. Whether these genetic variations~     contribute to differential responses to antifolate drug in patients with rheumatoid arthritis~     (RA) remains to be investigated in the Taiwanese population.~      Objective. The goal of the present study is to investigate the interactions between genetic~     variations in folate genes and the efficacy/side effects of anti-folate disease-modifying~     antirheumatic drug in Taiwan.~      DESIGN. A cross-sectional study involving 100 patients with RA were enrolled from TCVGH.~     Genotypes in methylenetetrahydrofolate reductase (MTHFR677C>T), tandem repeat polymorphism in~     thymidylate synthase enhancer region (TSER) and folylpoly-gamma-glutamate synthetase~     (FPGS1901T>C) were determined by RFLP or pyrosequencing.~   "
200044|NCT00944307|"~     The purpose of this study is to test whether there is a drug interaction between raltegravir~     (a medicine used to treat the human immunodeficiency virus or HIV) and antacids.~   "
200045|NCT00944294|"~     Binodenoson (an experimental drug) and adenosine (an FDA-approved drug that is currently used~     by doctors) are used to increase blood flow to the heart just like when a person exercises on~     a treadmill. Using imaging techniques, this increased blood flow can help determine if areas~     of the heart are not getting enough blood and oxygen during exercise. The purpose of the~     study is to determine if binodenoson is as good as adenosine in determining if there are~     areas of the heart not getting enough oxygen when blood flow to the heart is increased.~   "
200046|NCT00944281|"~     To assess zinc-related biochemical and functional responses among young Burkinabe children~     with a presumed high risk of zinc deficiency who receive micronutrient products containing~     different amounts of zinc, provided with or between meals.~   "
200047|NCT00944268|"~     To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L,~     Crataegus oxyacantha and Salix alba L in mild and moderate anxiety.~      Clinical study phase III, multicenter, prospective, open.~      Patients will be included in sufficient quantity to achieve the minimum number of 124~     evaluable patients.~   "
200048|NCT00944255|"~     BACKGROUND. Polymorphisms occur in several genes encoding key enzymes in the folate pathway~     may affect drug metabolism in patients with rheumatoid arthritis. Whether these genetic~     variations contribute to differential responses to antifolate drug in patients with~     rheumatoid arthritis (RA) remains to be investigated in the Taiwanese population.~      OBJECTIVE. The goal of the present study is to investigate the interactions between genetic~     variations in folate genes and the efficacy/side effects of anti-folate disease-modifying~     anti-rheumatic drug in Taiwan.~      DESIGN. A cross-sectional study involving patients with RA were enrolled from TCVGH. Disease~     activity, drug efficacy and associated side-effects were assessed.~      Genotypes in folylpoly-gamma-glutamate synthetase and reduced folate carrier were determined~     by RFLP or pyrosequencing.~   "
200049|NCT00944242|"~     -  Objective:~             -  To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited,~               India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administered as a~               1X100 mg tablet, under fasted conditions.~        -  Study Design:~             -  Single-dose, open-label, randomized two-way crossover.~   "
200050|NCT00944229|"~     A diet rich in Omega-3 (fish oil) reduces plasma triglycerides and the risk for ischemic~     heart disease. Recently, a large trial evaluating treatment with Omega 3 in heart failure~     patients suggested that omega 3 may lower the risk of death from CHF. The mechanism of this~     potential benefit is not well understood.~      Methods:~      Forty patients will be enrolled in the study. Twenty patients will receive Omega 3 (lovaza 4~     gm a day) and 20 patients will receive placebo. All subjects will have assessment of their~     exercise capacity and blood vessel function before and after an 8 week treatment period.~     About 4 table spoons of blood will be drawn throughout the study.~      Expected results:~      The investigators believe that omega 3 may improve the ability to exercise and improve blood~     vessel function.~   "
200051|NCT00944216|"~     Keratosis pilaris (KP) is a benign skin condition that often is very frustrating for the~     patients and treating physicians. The investigators are interested to see if the study~     product is effective in treating moderate to severe KP.~   "
200052|NCT00944203|"~     This is an open label, prospective, test of superiority efficacy trial of Ipomea pes-caprae~     ointment as an add-on therapy in patient with jellyfish dermatitis. Each patient will receive~     standard medical treatment depend on the severity of the disease. The doctor will divide the~     dermatitis area of each patient into two parts. Ipomea pes-caprae ointment will be applied as~     an add-on therapy to the test area, while the ointment will not be applied to the control~     area. Patients will be asked to come for follow up 6 times in the 28-days study period.~     Primary objective is to compare the healing time of dermatitis in both areas.~   "
200063|NCT00944060|"~     1) to evaluate treatment fidelity of DRRP: study design, training of interventionists,~     delivery and receipt of the intervention, and application of the intervention in real-life~     settings; 2) to identify successful strategies for participant recruitment and maintaining~     active participation; 3) to collect and analyze preliminary indicators of DRRP's effect on~     dietary intake, physical activity, stress responses, and body weight; and 4) To evaluate~     sample representativeness of the target audience, implementation and acceptability of DRRP,~     and attrition rate.~   "
200064|NCT00944047|"~     The purpose of this study is to find out if there is a benefit of adding Herceptin~     (trastuzumab) to standard chemotherapy in this type of breast cancer.~   "
200053|NCT00944190|"~     The proposed project will evaluate the efficacy of a telephone-delivered self-management~     (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple~     sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is~     hypothesized that if the effects of these conditions are reduced, study participants will~     demonstrate improved participation in the community and improved employment outcomes. This~     project is important because the majority of persons with MS experience one or more of the~     following secondary conditions: fatigue, pain, depression, and cognitive impairment. These~     secondary conditions are not always readily apparent and constitute what has been described~     by our Rehabilitation Research and Training Center as hidden disabilities. Secondary~     conditions such as pain, depression, fatigue, and cognitive impairment frequently not only~     cause distress in their own right but also affect employment, participation, and quality of~     life. Having more than one often compounds the effect; the effect of all may be greater than~     the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment~     can worsen depression).~      It is critical that this constellation of secondary symptoms be addressed using state of the~     art techniques based on self-management training and that intervention effects be documented~     with carefully controlled treatment efficacy studies.~   "
200054|NCT00944177|"~     -  Objective:~             -  A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the~               Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to~               an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®,~               Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.~        -  Study Design:~             -  Randomized,single-dose,2-way crossover.~   "
200055|NCT00944164|"~     The overall objective of this pilot is to demonstrate the feasibility of a low-cost~     intervention targeting obesity prevention among children in a primary care setting.~      Specifically, the investigators aim to answer the following questions:~      Can the investigators recruit and retain patients using the methods proposed, and how easy or~     difficult will this process be?~      Can physicians deliver the proposed intervention messages in the time the investigators have~     proposed?~      Can the phone counselor reach participants and accomplish the goals outlined for these calls?~      Can the investigators obtain the data proposed and within the proposed time frame?~   "
200056|NCT00944151|"~     Research study to determine if putting local anesthetic through one or two tiny tubes next to~     the nerves that go to the area the patients are having surgery on (abdomen or pelvis), will~     improve pain control following surgery. This study will also help determine if patients~     require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with~     their postoperative pain control.~   "
200057|NCT00944138|"~     Obesity plays a causal role for kidney disease incidence and progression. Moderate weight~     loss reduces the high metabolic demands on the kidney and decreases proteinuria in both~     diabetic and non-diabetic nephropathies. However, maintaining behavioral changes for weight~     loss is very challenging, and common chronic kidney disease (CKD) co-morbidities such as~     decreased exercise capacity only compound this difficulty. Moreover, no weight loss~     medications have been adequately tested in adults with CKD and most are contraindicated in~     this population. Mindful meditation or mindfulness in addition to other relaxation~     techniques may help adults lose weight by interrupting learned behavior, curbing compulsive~     eating, and reducing stress and appetite. Although mindful meditation and other relaxation~     techniques have gained the attention of the mainstream media for obesity treatment,~     scientific data on its efficacy remain limited. Due to the short duration of this study,~     substantial weight loss in any participant is not expected. Instead, the primary purpose of~     this study is to examine the feasibility of a randomized controlled trial of mindful~     meditation relaxation techniques combined with standard care compared to standard care alone~     for the treatment of obesity among Veterans with CKD.~   "
200058|NCT00944125|"~     The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single~     LV pacing (BiV pacing) to see if Dual LV pacing:~        1. Improves the way the heart's left ventricle functions~        2. Decreases the number of hospital and clinic visits for heart failure related symptoms~        3. Slows the rate patients experience certain heart failure symptoms~        4. Reduces uncoordinated heart contractions~   "
200059|NCT00944112|"~     The most effective transfusion practice in critically ill ICU patients is unknown. Currently~     the data is unclear as to whether a liberal or restrictive transfusion policy is of most~     benefit to patients in the short and longer term. The aim of this study is to test the~     hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110~     g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion~     trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill~     patients requiring prolonged ICU stay (≥4 days).~      Patients will be randomised to one of two transfusion strategies on a 1:1 basis~      Group 1 Restrictive RBC Transfusion group:~      Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with~     a target Hb concentration of 71-90 g/L during the intervention period.~      Group 2 Liberal RBC transfusion group:~      Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with~     a target of 91-110 g/L during intervention. These patients will all receive a transfusion on~     the day of randomisation.~      Duration of Intervention:~      Remainder of ICU stay or 14 days from randomisation, whichever is longer~      Follow-Up~      Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.~      This is a feasibility study that will provide essential data to ensure the success of the~     full trial. A qualitative study will also be carried out to explore potential reasons for~     non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker~     sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused~     group associated with transfusions.~   "
200060|NCT00944099|"~     The purpose of this research is to test the effect of manipulating eating frequency on hunger~     and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month~     behavioral weight loss intervention.~   "
200061|NCT00944086|"~     In This Study, Our Goal is to Compare the Effects of Recruitment Manoeuvre Which is Applied~     With Different Oxygen Concentrations on Oxygenation and Respiratory Mechanics During~     Pneumoperitoneum~   "
200726|NCT00935363|"~     The purpose of this study is to investigate if the drugs rifampin and fluconazole when given~     together increase the concentrations in the body of the oral diabetes medication glyburide.~   "
200065|NCT00944034|"~     This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of~     a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously~     primed with rMenB+OMV NZ according to two different three-dose immunization schedules in~     infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will~     also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following~     the two different immunization schedules, in order to identify the optimal timing for~     boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12~     (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort~     of subjects enrolled). These subjects will generate data for assessing the safety and~     immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls~     for a descriptive comparison of antibody persistence and booster responses for the other~     groups.~   "
200066|NCT00944021|"~     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral~     administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly~     diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive~     standard TB treatment.~   "
200067|NCT00944008|"~     The primary objective is:~        -  To determine the efficacy and safety of DepoCyte®, as the only intrathecal (IT)~          prophylaxis of neuromeningeal relapse for patients between 16 and 30 years old diagnosed~          with acute lymphoblastic leukemia of standard risk treated with the PETHEMA LAL-RI-08~          Protocol Chemotherapy schedule.~      The secondary objectives are:~        -  To evaluate the tolerability of IT DepoCyte® as CNS prophylaxis of CNS via IT for~          patients between 16 and 30 years old with ALL of standard risk.~        -  To compare the frequency of relapse in CNS for patients between 16 and 30 years old with~          standard risk ALL treated with the PETHEMA LAL-RI-08 Protocol Chemotherapy schedule and~          receiving DepoCyte® as the only IT CNS prophylaxis, with that observed in an historic~          group of patients of identical risk that were treated with the PETHEMA LAL-RI/96~          protocol (same systemic chemotherapy and double administration of triple intrathecal~          chemotherapy)~        -  To evaluate the frequency of systemic relapses of standard risk ALL patients between 16~          and 30 years old treated with the PETHEMA LAL-RI-08 Protocol and who receive DepoCyte®~          as the only IT prophylaxis of CNS involvement and to compare with those observed in the~          identical risk patients treated with PETHEMA LAL-RI/96 protocol (same systemic~          chemotherapy and double administration of triple IT chemotherapy)~   "
200068|NCT00943995|"~     Hypotheses:~        1. The provision of thrice weekly subcutaneous (SQ) recombinant growth hormone (rGH)~          therapy to children receiving in-center hemodialysis (HD) will result in improved~          growth.~        2. The provision of thrice weekly SQ rGH therapy to children receiving in-center HD will~          result in improved lean body mass, nutritional status and quality of life.~      TIW rGH treatment regimen (0.35 mg/kg/week divided into 3 doses, each dose being given at the~     conclusion of the dialysis treatment) for up to 2 years; growth response, Dual energy X-ray~     absorptiometry (DEXA), and quality of life (QOL) will be measured. The goal is to enroll 20~     children who are Tanner 1 with decreased height SDS and/or decreased height velocity standard~     deviation scoreS (SDS).~      If this therapy is demonstrated to be efficacious and improves growth and QOL, this therapy~     could be easily implemented for all eligible children on HD, since parental acceptance should~     be better without having to administer the rGH at home and compliance for the child will be~     assured.~      The investigators thus propose an important study that has the ability to advance their~     understanding and provide evidence for the best methods to promote growth in children on~     dialysis. The results of this study will result in important information that will be of~     value to the entire pediatric nephrologist community, including health care professionals,~     patients, and families. In a real sense, this study will build on the 2006 Consensus~     Conference guidelines for evaluation and treatment of growth failure in children with chronic~     kidney disease (CKD). This will provide evidence for critical management decisions that can~     help insure better growth opportunities to more children with CKD.~   "
200069|NCT00943982|"~     Background:~        -  Uveitis is a serious inflammatory condition that affects the eye and can cause vision~          loss. A common secondary problem associated with uveitis is macular edema (swelling).~          The macula is the part of the eye that is important for central vision, and swelling of~          the macula can lead to further vision loss. This condition is usually treated by~          medicines that target the immune system, but these medicines sometimes do not work or~          may cause side effects.~        -  Interferon gamma-1b (Actimmune(Registered Trademark)) is a bioengineered protein that~          can alter the way inflammatory cells work in the immune system. Interferon gamma-1b is~          given as an intramuscular injection; however, this study will use the drug as an eye~          drop. This study represents the first time that interferon gamma-1b is given as an eye~          drop. Researchers hope that interferon gamma-1b will treat macular edema by decreasing~          the swelling in the back of the eye.~      Objectives:~      - To investigate the safety and effectiveness of treating uveitis-associated macular edema~     with interferon gamma-1b.~      Eligibility:~      - Individuals 18 years of age and older who have been diagnosed with macular edema associated~     with uveitis (in one or both eyes) for at least 3 months.~      Design:~        -  Participants will have three planned clinic visits during this study over the course of~          2 weeks.~        -  All participants will have a medical history and eye examination.~        -  When receiving the drops, participants will have optical coherence tomography (a~          detailed scan of the retina) 60 minutes and 30 minutes before the drops; upon receiving~          the drops; and 30, 60, and 120 minutes after receiving the drops.~        -  After receiving the drops, participants will have another eye examination, blood drawn~          for samples, and further scans.~        -  Participants will be asked to return to the NIH Clinical Center 1 week after receiving~          the drops for an evaluation....~   "
200070|NCT00943969|"~     The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the~     most frequently surgical methods performed and combines restrictive and malabsorptive~     procedures. Different data suggest that this surgery may modify drug absorption and we think~     it would be clinically relevant to describe the consequences of gastric bypass on drug~     systemic exposure in obese patients, since no data on the comparison between the~     pharmacokinetics (PK) of a drug before and after surgery are available and help to predict~     the drugs posology.The investigators decided to study the morphine because there is a lack of~     information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese~     subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range~     frequently prescribed in obese patients.~   "
200090|NCT00943709|"~     RATIONALE: Controlling blood sugar levels may be effective in preventing infections in~     patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.~      PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels~     works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic~     leukemia.~   "
200766|NCT00934830|"~     Question: Is the effect of therapeutic ultrasound equally effective to antibiotic for~     treatment of sinusitis? Design: A randomized clinical trial with concealed allocation,~     self-assessment by the subjects and intention-to-treat analysis.~   "
200071|NCT00943956|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Androgens can cause the~     growth of prostate cancer cells. Antihormone therapy, such as bicalutamide and leuprolide~     acetate may lessen the amount of androgens made by the body. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving everolimus together with bicalutamide,~     leuprolide acetate, and radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with bicalutamide and leuprolide acetate in treating patients with high-risk~     locally advanced prostate cancer undergoing radiation therapy.~   "
200072|NCT00943943|"~     The goal of this clinical research study is to learn the most tolerable dose of Nexavarâ~     (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim)~     to patients with AML. The safety of this combination will also be studied.~      Funding Source - FDA OOPD~   "
200073|NCT00943930|"~     This study is designed to investigate the associations among marijuana's discriminative~     stimulus, reinforcing, subjective (e.g. craving) and physiological effects, and to assess the~     relative ability of oral THC to block these effects.~   "
200074|NCT00943917|"~     The purpose of this study is to determine safety, efficacy and tolerability of various doses~     of ITCA 650 in subjects with type 2 diabetes.~   "
200075|NCT00943904|"~     Sacral nerve stimulation (SNS) implantation is a minimally invasive procedure which has~     current FDA approval for urinary urge incontinence, urgency-frequency syndrome and~     non-obstructive urinary retention, and has been available in the United States since 1997.~     The SNS delivers non-painful, mild electrical pulses to the sacral nerves to modulate the~     reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal~     voiding function. While SNS has been shown to have efficacy for the aforementioned~     conditions, the exact mechanism of action is unknown, but it is believed to work primarily~     through the somatic afferent system in promoting inhibitory reflex pathways to facilitate~     urine storage. The degree of stimulation is thought to be at a level that only evokes a~     sensory and not a motor response; however this has not been tested.~   "
200076|NCT00943891|"~     1. To determine the association between LVD and clinico-pathologic variables in archived~          colorectal cancer and Nasopharyngeal carcinoma specimens~        2. To determine the association between VEGF-C,-D expression with COX-2 expression and~          clinico-pathologic variables in colorectal cancer and Nasopharyngeal carcinoma~        3. To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma~          Lymphangiogenesis and factors modulating lymphangiogenesis are associated with~          clinico-pathological outcome in Nasopharyngeal carcinoma and colorectal cancer.~          Celecoxib down-regulates lymphangiogenesis Archival colorectal cancer and Nasopharyngeal~          carcinoma tumor specimens will be obtained from the Department of Pathology. To~          determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma, the~          investigators intend to analyze archived specimens collected in a previously conducted~          study. Colorectal tumor and nodal specimens and Nasopharyngeal carcinoma primary will be~          examined for MVD, LVD and growth factor expression using established haematoxylin and~          eosin and immunohistochemical techniques. Quantification of LVD and MVD shall be~          performed by two pathologists blinded to clinico-pathological variables using~          standardised methods.~   "
200077|NCT00943878|"~     The purpose of this study is to assess the safety and immune response (body's defense against~     disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study~     will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make~     it most effective. Participants will include up to 850 healthy adults, ages 18 and older.~     Participants will receive 2 H1N1 vaccines in addition to placebo (inactive substance) and the~     seasonal flu shot over 3 study visits about 21 days apart. Study procedures include: medical~     history, physical exam, maintaining a memory aid, and blood sample collection. Participants~     will be involved in the study for about 8 months.~   "
200078|NCT00943865|"~     Obese patients with metabolic syndrome without diabetes or ischemic heart disease were~     randomized to three lifestyle interventions: 1. hypocaloric tailored diet with standard~     recommendations 2. pragmatic healthy style diet adapted to brazilian habits with portion~     control and pedometers to perform 10000 steps daily recorded or 3. pragmatic healthy style~     diet adapted to brazilian habits with portion control plus fitness three times a week under~     direct supervision. The main outcome was brachial reactivity, a surrogate marker of~     atherosclerosis, and secondary outcomes were cardiometabolic profile, arterial pressure and~     anthropometric measures: weight,waist circumference and bioimpedanciometry to access fat~     proportion and insulin sensitivity.~   "
200079|NCT00943852|"~     This study will qualify a functional model that can measure central blood pressure and~     vascular compliance effects through noninvasive means.~   "
200080|NCT00943839|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients~     with kidney cancer.~   "
200081|NCT00943826|"~     This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the~     current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide~     followed by adjuvant temozolomide) as compared to the current standard of care alone.~     Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram~     (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with~     radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus~     temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6~     weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10~     mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4~     week cycle) for 6 cycles of maintenance treatment or until disease progression or~     unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab~     (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study~     treatment was until disease progression.~   "
200117|NCT00943358|"~     The purpose of this study is to evaluate the antibody response to one and two doses of~     influenza A/H1N1v vaccine in healthy adults.~   "
200972|NCT00932100|"~     The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation~     System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.~   "
200082|NCT00943813|"~     At Memorial Sloan-Kettering Cancer Center the investigators want to provide the best care to~     their patients. One way to do this is to evaluate the ways that doctors communicate with~     patients. To this end, the Department of Psychiatry and Behavioral Sciences runs a~     Communication Skills Training and Research Laboratory. One goal of this laboratory is to~     evaluate doctor-patient communication and provide training in how to improve the quality of~     this communication.~      Invitation to participate in this pilot project does not mean that a problem with~     communication has been identified in your doctor's practice. Rather, it is because your~     doctor and the fellow working with your doctor have agreed to cooperate with us as the~     investigators develop strategies to train physicians, nurses and other clinical personnel to~     communicate with cancer patients in as effective and sensitive a manner as possible.~   "
200083|NCT00943800|"~     The primary objective is to assess the rate of engraftment with combined haploidentical-cord~     blood transplantation. The secondary objective is to evaluate the incidence and severity of~     acute and chronic graft-versus-host disease (GVHD).~   "
200084|NCT00943787|"~     The researchers plan to test the following hypothesis:~      A good level of glucose control in Type 1 Diabetes Mellitus (T1DM) is dependent on two levels~     of feedback from the body:~        1. the transport of insulin through small blood vessels: suggesting that hypoglycemia leads~          to increased insulin sensitivity which then causes recurrent hypoglycemia;~        2. the endocrine level, defined as insulin-glucose interaction and hormonal~          counter-regulation.~      The researchers plan to investigate the relationships between hypoglycemia, insulin~     transport, and counter-regulation. This study will ultimately lead to a better understanding~     of risk for recurrent hypoglycemia.~   "
200085|NCT00943774|"~     Baroreflex sensitivity is integral to blood pressure regulation, and varies among healthy,~     normotensive individuals. A reduced compensatory ability of baroreflex buffering in patients~     with carotid denervation results in blood pressure variability and an elevated blood pressure~     response to mental stress. Furthermore, 24-hour ambulatory blood pressure variability may~     also be a significant and independent risk determinant of cardiovascular disease. It remains~     unknown whether the degree of baroreflex sensitivity and ambulatory blood pressure~     variability are predictive of the pressor response to sympathoexcitatory stress in healthy~     humans. In this study the investigators propose a comprehensive evaluation of the~     relationships among the pressor and forearm vasodilator response to sympathoexcitation,~     ambulatory blood pressure variability, and baroreflex sensitivity in healthy normotensive~     subjects. Ultimately this study will provide preliminary data and protocol development for~     large-scale high resolution phenotyping in population-based trials aimed at determining the~     functional relevance of candidate gene variation in intermediate physiological traits~     pertinent to the pathogenesis of hypertension and cardiovascular disease.~   "
200086|NCT00943761|"~     This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated~     interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV)~     infection who did not achieve viral eradication while participating in a prior vaniprevir~     clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184;~     and MK-7009-029, NCT00954993).~   "
200087|NCT00943748|"~     Few available drugs can slow the progression of neurodegenerative pathologies such as~     Parkinson's disease (PD). One of the recent hypotheses concerning the reduction of oxidative~     stress and neuron death features a harmful effect of iron, which may reach abnormally high~     levels in the substantia nigra (SN) pars compacta (iron overload has been seen in the~     substantia nigra in parkinsonian patients and in the~     1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) mouse model of PD). Iron overload is~     harmful because it reacts with hydrogen peroxide (H2O2) produced during the oxidative~     deamination of dopamine, generating hydroxyl radicals which then damage proteins, DNA and~     phospholipid membranes and may be responsible for neuron death. The use of an iron chelator~     (clioquinol) produces a reduction in neuron death in the MPTP mouse model. In humans, a~     special, partially refocused interleaved multiple echo (PRIME) MR sequence has been used to~     study the relaxation time (T2*) and quantify iron overload in the SN of PD patients and the~     nucleus dentatus of patients with Friedreich's ataxia. T2* sequences have revealed a decrease~     in iron overload following treatment with the chelator deferiprone, in parallel with a~     clinical improvement in these patients. Furthermore, the very recent open label use of~     deferiprone in rare serious, systemic, neurological iron overload diseases (Neurodegeneration~     with Brain Iron Accumulation (NBIA)) has revealed a clinical improvement after 6 months, with~     2 case reports from our group and another from an Italian group (Forni et al., 2008). The~     safety of the low dosages of deferiprone (20 to 30 mg/kg/day) used in neurology appears to be~     much greater than for the high dosages (75 to 100 mg/kg/day in 3 doses) used in hematology to~     decrease post-transfusion iron overloads in thalassemia major.~      Hence, the investigators wish to evaluate the effect of treatment with an oral iron chelator~     which is capable of crossing the blood-brain barrier (deferiprone) on iron overload in the~     SN(as assessed by the T2* sequence) with respect to the progression of clinical sign in PD.~     It is expected a 6-month course of deferiprone able to produce a moderate reduction in iron~     overload of the SN, associated with a drop in the motor handicap score. Depending on the~     risk/benefit balance determined in this initial pilot study, a larger, multicenter~     neuroprotection study could be envisaged.~   "
200088|NCT00943735|"~     The primary objective of the study is to assess the level of medication adherence observed~     among subjects receiving a specific combination of education and support materials (YourWay~     plan) along with a prescription for fesoterodine.~   "
200089|NCT00943722|"~     This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human~     papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent~     participants between 9 and 15 years old and demonstrate the consistency of the manufactured~     vaccine through assessment of 3 different final manufacturing process lots of V503.~      The primary hypotheses are as follows:~        1. The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys~          and girls 9 to 15 years of age and young women 16 to 26 years of age is generally~          well-tolerated.~        2. 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and~          adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV~          type compared to young women 16 to 26 years of age who are seronegative at Day 1 and~          polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type,~          as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers~          (GMTs) at 4 weeks post-dose 3.~        3. The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent~          and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant~          HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and~          PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6,~          11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.~        4. Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine~          induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33,~          45, 52, and 58 GMTs at 4 weeks post-dose 3.~   "
200091|NCT00943696|"~     Tradition holds that the intake of different drinks with a meal has an important influence on~     the digestion of food and postprandial symptoms such as fullness, bloating and satiety;~     however this assumption have never been subjected to controlled study~      A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry~     schnapps (Kirsch) are often attributed either positive or negative effects on the~     gastrointestinal tract.~      In this study the effect of white wine vs. tea intake during and an alcoholic digestive~     following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral~     perception will be investigated using a randomized, controlled study design.~      The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric~     emptying by breath-test.~   "
200092|NCT00943683|"~     A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.~   "
200093|NCT00943670|"~     This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect~     of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive~     locally advanced or metastatic breast cancer and to make preliminary assessments regarding~     the safety, tolerability, and efficacy of combined T-DM1 and pertuzumab in patients with~     early disease progression.~      The QT interval is a measure of time between the start of the Q wave and the end of the T~     wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated~     using Fridericia's correction; the QTcB interval is the QT interval as calculated using~     Bazett's correction.~   "
200094|NCT00943657|"~     The purpose of this study is to verify the immunogenicity and tolerance of a trivalent~     seasonal influenza vaccine with strain composition according to World Heath~     Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly~     licensing application.~   "
200095|NCT00943644|"~     This study is being done to test the ability of an investigational mammography camera to find~     small tumors in patients' breasts.~   "
200096|NCT00943631|"~     The purpose of this study is to assess the safety and the body's immune response (body's~     defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and~     elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no~     history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old,~     and the other 200 will be greater than or equal to 65 years of age. Participants will be~     randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1~     vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine~     injections on days 0 and 21 in the arm muscle. Study procedures include: medical history,~     physical exam, maintaining a memory aid, and blood sample collection. Participants will be~     involved in study related procedures for approximately 7 months.~   "
200097|NCT00943618|"~     The goal of this clinical research study is learn if the combination of Chantix (varenicline)~     and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline~     when given alone. Researchers also want to learn if this drug combination can reduce cravings~     and other negative symptoms of nicotine withdrawal better than varenicline does alone. The~     safety of this drug combination will also be tested.~   "
200098|NCT00943605|"~     The objective of this clinical study is to evaluate the incidence of partial skin necrosis~     following modified-radical mastectomy with or without same-day (two-stage) reconstruction~     with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative~     pain, drain output, and skin scarring following surgery; and to compare these endpoints to~     the current standard of care (SOC).~   "
200099|NCT00943592|"~     This is a clinical research study designed to evaluate whether a conditioning regimen~     consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine~     supported by donor blood cells will result in rapid recovery and a high rate of long-lasting~     remissions in patients with leukemia, lymphoma and myeloma.~   "
200100|NCT00943579|"~     This is an open-label extension study available only to subjects who completed an earlier~     double-blind, placebo-controlled study of sapropterin in children with autism.~   "
200101|NCT00943566|"~     The study hypothesis is that the safety and efficacy of sufentanil following transdermal~     application is comparable to sustained release morphine sulphate tablets in patients with~     chronic pain due to cancer.~   "
200102|NCT00943553|"~     The purpose of this study is to evaluate the efficacy and safety of decitabine when used~     before chemotherapy to treat leukemia in pediatric patients. The study will also evaluate the~     ways decitabine is affected or changed when used in the human body.~   "
200103|NCT00943540|"~     The licensed dose of raltegravir is 400 mg twice daily with or without food. Raltegravir is~     metabolized predominantly through glucuronidation by UGT1A1. Atazanavir increases the plasma~     concentrations of raltegravir 400 mg twice daily by 72% due to inhibition of UGT 1A1.~      This suggests that combined use of atazanavir and a lower dose frequency of raltegravir, once~     daily for example, is possible. Another reason why raltegravir most likely can be applied is~     that its pharmacodynamic effect is not related to Cmin but to AUC which is expected to be~     similar for an 800mg QD dose when compared to 400mg BD. Phase III clinical trials evaluating~     QD dosing of raltegravir are currently ongoing and interim results are expected to be~     published in mid 2009.~      A regimen of atazanavir and raltegravir in combination with lamivudine or emtricitabine may~     be a well tolerated and effective NNRTI-, and ritonavir-sparing regimen that could be an~     attractive option for both first and second line (after NRTI/NNRTI failure) treatment~     regimens.~   "
200104|NCT00943527|"~     This study is to examine the effects of menstrual cycle, hormone therapy, and the use of~     tamoxifen on Tc-99m sestamibi uptake.~   "
200129|NCT00943202|"~     The purpose of this study is to assess the safety and immune response (body's defense against~     disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study~     will help determine how and when the H1N1 flu shot should be given with the seasonal flu shot~     to make it most effective. The 650 participants will be divided into the following age~     groups: infants from 6 months-36 months old, children 36 months-9 years old, and adolescents~     10-17 years old. Each age group will have 200 children. There are 4 treatment groups in each~     age level. Study procedures include: medical history, targeted physical exam based on~     history, maintaining a memory aid, and blood sample collection. Participants will be involved~     in the study for about 8 months.~   "
200130|NCT00943189|"~     Purpose: Fetal anomalies scan at the time of Nuchal Translucency (NT) study.~   "
200105|NCT00943514|"~     Background:~        -  Bronchiectasis is a disease characterized by airways that are inflamed, abnormally~          dilated, and chronically infected. Individuals with bronchiectasis have a history of~          chronic and recurring respiratory infections. Depending on the underlying cause, these~          infections may involve the entire respiratory tract, resulting in sinus, ear, and lung~          disease.~        -  Bronchiectasis continues to be a significant problem in developing countries and in~          specific groups of individuals, particularly in people who have cystic fibrosis.~          Although treatments are available or under development for bronchiectasis related to~          cystic fibrosis, many of the disease-specific treatments may not be effective for~          bronchiectasis not related to cystic fibrosis.~      Objectives:~      - To study the natural history of bronchiectasis to identify inherited and immune factors~     that may explain why certain individuals have chronic recurring infections.~      Eligibility:~        -  Individuals 5 years of age and older who have an established diagnosis of bronchiectasis~          or a history of chronic/recurring respiratory infections.~        -  Direct family members (e.g., parents, siblings, children) of patients in the study may~          also be asked to participate.~      Design:~        -  Potential participants will be screened with an initial clinic evaluation and full~          medical history, as well as a general quality of life and respiratory symptom~          questionnaire.~        -  The following standard procedures may be done as part of the study: air sampling from~          the nose; imaging studies, which may include an x-ray or computed tomography (CT), lung~          function tests; and collection of samples of blood, urine, and sputum (phlegm or mucus).~          Other tests may be performed as required by the researchers, and will be explained to~          patients as needed.~        -  Both patients and relatives (if asked to participate) will provide the following~          samples: blood or buccal (cheek swab) cells for genetic testing, sputum, and urine.~        -  To prevent infections and potential disease progression, patients may receive standard~          medical care and treatment for bronchiectasis and related infections during this~          protocol.~        -  Patients older than 18 years of age will be invited to join the Bronchiectasis Research~          Registry, a program supported by the Chronic Obstructive Pulmonary Disease (COPD)~          Foundation. The purpose of the program is to identify a group of people who are~          interested in receiving information about research studies focused on bronchiectasis and~          possibly participating in these research studies. Participants may be offered the~          opportunity to participate in selected clinic trials related to bronchiectasis or~          related medical conditions.~   "
200106|NCT00943501|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     clinical trial is to investigate the safety, tolerability, pharmacokinetics (the~     determination of the concentration of the administered medication in blood over time) and~     pharmacodynamics (the determination of the effect over time and the duration of action) of~     multiple doses of liraglutide in the pediatric population (children).~   "
200107|NCT00943488|"~     The purpose of this study is to assess the safety and immune response (body's defense against~     disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations.~     The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1~     infection or vaccination. Two hundred individuals will be 18-64 years old, and the other 200~     will be greater than or equal to 65 years of age. Participants will be randomly assigned to 1~     of 2 possible vaccine groups: group 1 will receive 15 micrograms (mcg) of H1N1 vaccine; group~     2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine injections on days 0~     and 21 in the arm muscle. Study procedures include: medical history, physical exam,~     maintaining a memory aid, and blood sample collection. Participants will be involved in study~     related procedures for approximately 7 months.~   "
200108|NCT00943475|"~     The surgery stress relives systemic inflammatory response by hormones and adrenergic~     receptors. When the pro-inflammatory mediator is higher than anti-inflammatory response, the~     physiologic status is impaired and the patient is more susceptible an infection and~     cardiovascular collapse. The anesthesia can abolish or minimize the surgery stress, improved~     more safety to the patient.~      This study is a double blind controlled trial with 40 patients divided in two groups (EMLA~     and Dorsal Penile Nerve Block - DPNB) submitted a standard inhalator anesthesia and~     postectomy surgery by Plastbell®. The investigators will be observe heart rate, respiratory~     rate, arterial pressure, involuntary movements during the surgery and pain in the~     pos-operatory.~      With this study, the investigators can define what tactic (EMLA or DPNB) associated a general~     anesthesia is more effective to relive the pain when children are submitted a postectomy by~     Plastbell®.~   "
200109|NCT00943462|"~     Positron Emission Tomography-Computed Tomography (PET-CT) with injection of~     18F-fluoroethylcholine (FEC) could be a useful tool in the evaluation and follow-up of~     patients who have been diagnosed with glioblastoma multiforme (GBM) and who are treated with~     radiotherapy and temozolomide by allowing, for example, the distinction of necrosis from~     tumour tissue. This tool could help the clinician in making therapeutic decisions for GBM~     patients.~   "
200110|NCT00943449|"~     The purpose of the study is to determine whether 4SC-201 alone or in combination with~     Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients~     refractory to Sorafenib monotherapy.~   "
200111|NCT00943436|"~     The purpose of this study is to determine whether or not energy and macronutrient intake~     changes when comparing habitually active and habitually sedentary college-aged males in two~     different sessions of one resting and one exercise.~   "
200112|NCT00943423|"~     RATIONALE: A PET scan may help doctors learn how the cancer responded to combination~     chemotherapy and whether radiation therapy is also required.~      PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it~     works in deciding whether patients who have received combination chemotherapy for stage IA or~     stage IIA Hodgkin lymphoma also need radiation therapy.~   "
200113|NCT00943410|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Trastuzumab may make tumor cells more sensitive to radiation~     therapy. Giving trastuzumab together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving trastuzumab~     together with external beam radiation therapy works in treating women with stage III or stage~     IV breast cancer.~   "
200114|NCT00943397|"~     Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who~     completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study.~     Additionally, patients with asthma who were 6 to 11 months of age and who had not~     participated in Protocol MK0476-176-01, could also enroll.~   "
200115|NCT00943384|"~     The chronOS Strip is a synthetic bone void filler manufactured from chronOS beta-tricalcium~     phosphate (β-TCP) granules and a resorbable polymer [poly(lactide co-ε-caprolactone)]. The~     chronOS Strip, combined with autogenous bone and/or bone marrow or autograft, is intended to~     be used in the spine for posterolateral fusion.~      The purpose of this prospective, multi-center clinical case series was to evaluate~     posterolateral fusion rates in a prospective series of patients with degenerative disc~     disease. The surgical procedure consisted of instrumented posterolateral fusion with~     interbody support. The chronOS Strip, combined with bone marrow aspirate and local bone, was~     applied to the posterolateral gutters.~   "
200116|NCT00943371|"~     A single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics~     of MK6349 in Type 2 Diabetics.~   "
200118|NCT00943345|"~     Introduction: The primary function of the gastrointestinal (GI) wall is digestion and~     absorption of nutrients that are important for growth and development. The second important~     function of the GI wall is forming an effective barrier to prevent penetration of potentially~     harmful components from the inside of the gut (lumen), via the GI wall, into the body.~      A compromised barrier function may play an important role in the development of a range of~     inflammatory GI diseases such as coeliac disease, Inflammatory Bowel Disease (IBD), food~     allergy, but also in the pathophysiology of postoperative complications. It is important and~     clinically relevant to have reliable GI permeability tests, however the existing test leave~     room for improvement.~      Rationale/aim: Three new tests are developed to assess gastrointestinal permeability in both~     normal controls with and without raised permeability, and in patients with coeliac disease.~     In the current study these new permeability tests will be evaluated and compared with the~     golden standard permeability test, the dual sugar test.~   "
200119|NCT00943332|"~     Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting~     for patients 6 years and younger and for patients over 6 years and older is percutaneous or~     open placement of titanium elastic intramedullary nails. The investigators would like to~     evaluate the current treatment protocol by comparing those patients 6 years and younger~     treated with closed reduction and spica casting to those 6 years and younger treated with~     percutaneous pinned with titanium elastic intramedullary nails or submuscular plating. The~     investigators will be comparing their post-operative functional level, pain management,~     impact on family and complications through chart and x-ray reviews. The goal is to improve~     patient care pre and post-operatively for those who have sustained a femoral shaft fracture 6~     years old and younger and increase the knowledge of those residents/physicians who care for~     this patient population.~   "
200120|NCT00943319|"~     The purpose of this study is:~        1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in~          combination with fludarabine as conditioning regimen for transplantation with in-vivo~          T-cell depletion.~        2. To evaluate disease free and overall survival after this conditioning regimen in~          patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).~        3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen.~        4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.~   "
200121|NCT00943306|"~     This was a long term follow on study to assess the continued long term safety and efficacy of~     lomitapide in patients with homozygous familial hypercholesterolemia.~   "
200122|NCT00943293|"~     This is a clinical research study designed to evaluate whether the administration of a~     vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag~     peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate~     increased graft versus leukemia (GVL) responses without causing graft-versus-host disease~     (GVHD).~   "
200123|NCT00943280|"~     To compare participation rates in screening for Barrett's Esophagus (BE) using sedated~     esophagogastroduodenoscopy (EGD), unsedated transnasal endoscopy and capsule endoscopy in a~     population based cohort. An age and gender stratified random sample of 300 patients from a~     previously defined (in terms of the presence or absence of symptoms of gastroesophageal~     reflux using a validated questionnaire) population based cohort from Olmsted County11, 12~     using the Rochester Epidemiology Project (REP), who have not undergone endoscopy, will be~     randomized to undergo screening using capsule endoscopy OR transnasal endoscopy OR~     conventional sedated endoscopy. The investigators will compare participation rates in the~     three arms.~      To identify factors associated with non-participation in population screening for BE. The~     investigators will compare demographic and clinical factors in participants and~     non-participants, to help predict non-participation using data from prior surveys (data has~     been collected on patient demographics, bowel and reflux symptoms, employment, education,~     somatization behavior, psychological profiles using the validated Gastroesophageal Reflux~     questionnaire [GERQ] and the Bowel Disease Questionnaire [BDQ]) which have been completed by~     all targeted subjects. This preliminary will allow us to identify barriers to screening and~     develop interventions to increase participation in future larger studies.~   "
200124|NCT00943267|"~     Recombinant human Activated Protein C (rhAPC) has been shown to reduce the mortality of~     patients with severe sepsis. The biological effects of APC are pleiotropic, and can be~     roughly divided in anticoagulant and cytoprotective effects. Lung infection and inflammation~     are associated with reduced bronchoalveolar levels of endogenous APC. Recent evidence derived~     from animal studies indicates that local administration of rAPC into the lungs exerts local~     anti-inflammatory and anticoagulant effects. In this study we propose to study the potential~     of locally administered APC, within a lung subsegment, to inhibit lipopolysaccharide (LPS)~     induced lung inflammation and coagulation in humans.~   "
200125|NCT00943254|"~     This study is being done to gain knowledge on how effective different approaches of providing~     a diagnosis and varying educational tools that include DVDs and multimedia or printed~     instruction sheets on your readiness to increase the subject's level of exercise, lose more~     weight, eat a healthier diet; and to assess the subject's awareness of their risk of heart~     disease and their readiness to participate in a comprehensive lifestyle modification program.~   "
200126|NCT00943241|"~     To expand the understanding of the uptake and distribution of Tc-99m sestamibi in the breast~     in a normal female population undergoing myocardial perfusion imaging using Molecular Breast~     Imaging (MBI).~   "
200127|NCT00943228|"~     The primary objective of this study is to determine whether 4 grams daily of mycophenolate~     mofetil (MMF) results in a greater proportion of individuals adequately exposed as measured~     by drug levels (area under the curve of > 40 mg*hr/L).~   "
200128|NCT00943215|"~     The purpose of this study is to gain knowledge about how participants behave and respond on~     their own after completing a 2-year intervention of calorie restriction.~   "
200131|NCT00943176|"~     The purpose of this study is to evaluate the use of modafinil in the treatment of fatigue in~     patients with Primary Biliary Cirrhosis.~      The general aim of the study is to identify a safe and effective therapy for fatigue in~     patients with primary biliary cirrhosis.~   "
200132|NCT00943163|"~     Cyclorotation of eyes may be affected by motion and orientation of the head and body. An~     automated alignment method with the technique of iris recognition was used to assess the~     amount and orientation of position-induced cyclorotation between preoperative wavefront~     measurement and laser refractive surgery.~   "
200133|NCT00943150|"~     The objective of this clinical study is to evaluate healing of incisions made with the PEAK~     PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and~     record key post-operative metrics following abdominoplasty with the PEAK PlasmaBlade 4.0~     versus current standard of care (SOC); and to evaluate performance metrics of the PEAK~     PlasmaBlade 4.0 during abdominoplasty.~   "
200134|NCT00943137|"~     The purpose of this study is:~        1. To determine the proportion of Asian patients achieving a target area under the curve~          (AUC) of 20-24 mg.h/L using a pharmacokinetically guided 5-fluorouracil (5-FU) dose~        2. To determine the safety and tolerability of dose adjusted 5-FU~        3. To correlate 5-FU pharmacokinetics with gene variants associated with the 5-FU pathway~          and with clinical outcomes~      Based on Western data, levels of 5-FU are highly variable when doses are based on BSA. A~     relationship between systemic plasma levels of 5-FU and treatment toxicity and efficacy~     exists. Whilst pharmacokinetically-guided dose management has been shown to improve 5-FU~     efficacy and tolerance, there is currently no data in Asian patients using this approach.~     Using pharmacokinetically guided 5-FU-dose adjustment, the investigators hypothesize the~     proportion of Asian patients achieving a target AUC of 20-24 mg.h/L is similar to that of~     Caucasians.~      METHODS:~      This is an open, non-randomised single center Phase II study evaluating dose adjusted 5-FU in~     patients receiving de Gramont, FOLFIRI or mFOLFOX-6 schedules.~   "
200135|NCT00943124|"~     This study will evaluate:~        1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin~          (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple~          combination tablet MK0524B.~        2. the bioequivalence of laropiprant and ER niacin when administered as the triple~          combination tablet MK0524B or as the double combination tablet MK0524A given together~          with simvastatin.~   "
200136|NCT00943111|"~     This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate~     (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals~     with enzyme replacement therapy (ERT).~   "
200137|NCT00943098|"~     The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD~     75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment~     of acute moderate-to-severe pain after dental impaction surgery.~   "
200138|NCT00943085|"~     This study will test a family-based therapy aimed at preventing or reducing the symptoms of~     bipolar disorder in at-risk children.~   "
200139|NCT00943072|"~     This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on~     vision function in subjects with macular edema as a consequence of central retinal vein~     occlusion.~   "
200140|NCT00943059|"~     Accumulation of lipid in skeletal and cardiac muscle has been associated with insulin~     resistance and diabetic cardiomyopathy. In skeletal muscle, lipotoxic damage has been~     suggested to lead to dysfunction of mitochondria. It remains unknown whether lipotoxicity~     leads to mitochondrial dysfunction in heart as well, and if so, whether this also leads to~     cardiomyopathy (failure of the heart). Although it has been shown that lipid lowering agents~     can improve insulin sensitivity, the effect of lowering free fatty acids on cardiac and~     skeletal muscle mitochondrial function remains unknown. In this study the investigators want~     to investigate whether lowering cardiac and muscular lipid content will improve mitochondrial~     and cellular function in type 2 diabetic patients.~      To this end, type 2 diabetic patients and body mass index (BMI)-matched controls will be~     included in a blinded cross-over design, in which subjects will receive a lipid lowering~     agent (Acipimox) or placebo for 2 weeks in random order. During treatment, diabetes~     medication will be stopped. Baseline measurements will be performed prior to the study and~     after each treatment to assess cardiac and muscular lipid accumulation, cardiac function,~     mitochondrial function and insulin sensitivity.~   "
200141|NCT00943046|"~     The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker~     leads.~   "
200142|NCT00943033|"~     Research aimed at assessing changes in depressogenic thinking and the ability to disengage~     from depressogenic thinking following Mindfulness-Based Cognitive Therapy~   "
200143|NCT00943020|"~     Surgical patients are usually starved for 8 hours before operation in order to ensure the~     stomach is empty and thus reduce the chances of vomiting during the anaesthetic. Recent~     studies have shown that this period of starvation is harmful as it 'weakens' the body before~     operation. To avoid the harmful effects of starvation, patients are now given carbohydrate~     (sugar-containing) drinks 2 to 4 hours before surgery. These drinks have been shown to make~     patients feel better, reduce sickness after the anaesthetic/surgery and result in a quicker~     recovery from operation. The optimum time of giving these drinks to patients before operation~     is unknown. Previous studies have shown that the drinks empty from the stomach within 2 - 4~     hours depending on their ingredients. The investigators would like to study the effects of~     adding protein and fat to these drinks on how quickly the drinks empty from the stomach. This~     study will investigate the hormone responses of the body following intake of 3 different~     drinks in order to determine the mechanisms that underlie the control of stomach emptying.~     This information will also allow us to improve the design of these drinks and this could help~     patients who undergo surgery who receive them.~   "
200144|NCT00943007|"~     The treatment of a specific subtype of highly malignant brain tumor (called glioblastoma or~     glioblastoma multiforme) consists of neurosurgical resection, followed by radiotherapy and~     mostly chemotherapy as well. Increased extent of tumor resection is associated with prolonged~     survival. The standard treatment uses conventional neuronavigation systems to increase extent~     of tumor resection. However, the quality of this form of neuronavigation decreases throughout~     surgery because of brain shift. This is caused by edema, loss of cerebrospinal fluid and~     tumor resection. A new form of neuronavigation uses intraoperative MRI to compensate for~     brain shift, and to check for the presence of residual tumor that can be removed.~      This study aims to compare the extent of glioblastoma resection between the standard~     treatment and intraoperative MRI.~   "
200145|NCT00942994|"~     The purpose of the study is to compare the combination of aliskiren, amlodipine and~     Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in~     minority Stage 2 hypertensive patients.~   "
200973|NCT00932087|"~     Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12~     metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls~   "
200146|NCT00942981|"~     Background:~        -  Some illnesses, such as schizophrenia, have effects on brain cells called dopamine~          receptors, which are required for normal brain function. People with schizophrenia have~          difficulty thinking and experience hallucinations and delusions. Medications that change~          brain dopamine receptors can decrease these hallucinations and delusions.~        -  The cause of schizophrenia and its association with brain dopamine receptors is not~          known but may be clarified by studying dopamine receptors in people who have dopamine~          disorders (such as schizophrenia) and those who do not. Researchers are interested in~          studying the dopamine system to gain a better idea of how dopamine disorders develop,~          which may lead to better medical care for people with schizophrenia.~      Objectives:~      - To study the amount and distribution of two types of dopamine receptors.~      Eligibility:~        -  Individuals between the ages of 18 and 60 who have schizophrenia.~        -  Healthy volunteers between the ages of 18 and 90.~      Design:~        -  Participants will undergo a full screening, with physical and psychological history, a~          neurological examination, and blood and urine samples.~        -  Participants will have a blood flow map of the brain recorded with a positron emission~          tomography (PET) brain scan. A magnetic resonance imaging (MRI) scan will also be~          performed to determine brain anatomy.~        -  To study the amount and distribution of dopamine receptors in the brain, participants~          will receive a small amount of a radioactive chemical in the vein, followed by a PET~          scan.~        -  The procedure will be performed twice in two separate sessions, once for [18F]fallypride~          and once for [11C]NNC-112.~   "
200147|NCT00942968|"~     The purpose of this study is to determine the long term tolerability and safety of dalteparin~     in subjects with cancer.~   "
200148|NCT00942955|"~     The hypothesis of this study is that POCT will shorten ED turn-around-time (TAT) such as~     blood drawing TAT, lab TAT, and decision TAT.~   "
200149|NCT00942929|"~     The investigators hypothesize that lung function would be adversely affected at the~     hypocaloric stage of adolescents suffering from anorexia nervosa.~   "
200150|NCT00942916|"~     This study is for those who had nontuberculous mycobacterial pulmonary infection with higher~     a serum inflammatory marker than those who had colonization.~   "
200151|NCT00942903|"~     This study is a short term feasibility study that aims to investigate patient satisfaction~     with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are~     considered are for example performance for stoma occlusion, speaking, breathing, appearance,~     compliance, and short-term impact on pulmonary symptoms.~   "
200152|NCT00942890|"~     The purpose of this randomized control study is to determine if administering neuromuscular~     electrical stimulation (NMES) to the thigh muscles of a below the knee amputee is more~     effective than the current standard of care in preserving thigh muscle strength. In addition,~     this study will examine the NMES treatment effects on the participant's gait, quality of~     life, functional performance of standing, walking, and stair climbing, and symptoms~     associated with residual and phantom limb pain. The primary aim is to compare NMES plus~     standard rehabilitation (treatment group) to the standard rehabilitation (control group) by~     measuring lower extremity muscle strength. The secondary aims are to compare NMES treatment~     group to the control group by measuring Quality of Life (QOL) and the symptoms associated~     with residual & phantom limb pain. In addition to the specific aims, this study will also~     examine the two groups for functional performance and gait patterns after prosthetic fitting.~   "
200153|NCT00942877|"~     Background:~        -  Alveolar soft part sarcoma is a type of cancer that develops in tissues that connect,~          support, or surround other organs in the body. It relies heavily on new blood vessels to~          grow and spread through the body. There is no effective systemic treatment for patients~          with alveolar soft part sarcoma.~        -  The drug AZD2171 (cediranib) is an experimental drug, not yet approved by the Food and~          Drug Administration. The drug blocks the creation of new blood vessels. The drug has had~          initial clinical trials, and researchers are interested in determining whether cediranib~          is effective in inhibiting tumor growth in individuals who have alveolar soft part~          sarcoma.~      Objectives:~      - To find out whether AZD2171 works in patients who have alveolar soft part sarcoma.~      Eligibility:~      - Individuals 18 years of age and older who have been diagnosed with alveolar soft part~     sarcoma.~      Design:~        -  After an initial screening visit, patients will take AZD2171 by mouth once a day, every~          day for the duration of the study. The treatment will be given in 28-day cycles.~        -  Patients will keep a study diary to record the doses taken, any missed doses, and any~          side effects.~        -  Patients will have the following tests and procedures during the treatment period:~          clinic visit with physical examination every 2 weeks, regular blood pressure monitoring,~          blood and urine tests, heart function tests, imagining scans to evaluate tumor size and~          response to the treatment, and possible tumor biopsy.~   "
200154|NCT00942864|"~     The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab)~     and investigate the anatomical and functional improvement following this treatment in~     patients with macular edema due to retinal vein occlusion (RVO).~   "
200155|NCT00942851|"~     Background:~        -  Blepharospasm is caused by excessive contraction of the muscles that close the eye. It~          can be treated with injections of botulinum neurotoxin (BoNT), which works by weakening~          those muscles.~        -  Acetyl Hexapeptide-8 (AH-8) is the active ingredient in a number of cosmetic creams used~          to treat wrinkles, and is marketed under the trade name Argireline(Copyright). Like~          BoNT, AH-8 works to weaken the muscles, but is available as a skin cream instead of an~          injection. AH-8 has never been used to treat people with blepharospasm.~      Objectives:~      - To determine if AH-8 can be used as part of a treatment regimen for blepharospasm.~      Eligibility:~      - Individuals 18 years of age and older who have blepharospasm and have been receiving~     successful treatment with botulinum toxin injections.~      Design:~        -  Participants will be involved in the study for a maximum of 7 months.~        -  Patients will have a complete physical and neurological exam, and will be asked~          questions about their blepharospasm. Patients will then receive BoNT injections in the~          same areas of the muscle around the eye and at the same doses that have been effective~          previously.~        -  After the injections, patients will receive a container of either the active cream (with~          AH-8) or cream without AH-8, and will be instructed on how to apply it.~        -  Patients will return 1 month after the first visit for another neurologic exam and~          questions, and will be asked about any side effects. Another supply of cream will be~          given.~        -  Five additional visits will take place on a monthly basis, and patients will be given~          additional supplies of the cream as needed. Patients will stop participating in the~          study if they require another BoNT injection for blepharospasm. The study will end after~          7 months.~   "
200344|NCT00940368|"~     Ginger root powder is found to be significantly effective,when given as an add-on therapy in~     reducing chemotherapy induced nausea and vomiting in children and adolescents receiving~     chemotherapy.~      It is very cost effective and as compared to the other add-on therapy drug like aprepitant.~   "
200156|NCT00942838|"~     The proposed study is a prospective cohort study incorporating patients with first recurrence~     ovarian or primary peritoneal cancer who will receive intraperitoneal chemotherapy in~     conjunction with whole abdomen radiation. The primary end point of this investigator~     initiated research study is to determine the toxicity associated with whole abdomen radiation~     in combination with intraperitoneal chemotherapy.~      Primary Objective:~        -  Determine the maximum tolerated dose (MTD) of whole abdomen radiation in conjunction~          with intraperitoneal cisplatin chemotherapy in the treatment of women with small volume~          (< 1 cm) recurrent ovarian cancer confined to the abdominal peritoneal cavity.~      Secondary Objective:~        -  Quality of Life assessment.~   "
200157|NCT00942825|"~     This is a randomized, open-label, multicenter, phase II study to compare a triplet~     combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered~     to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial~     effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according~     to a once-every-3-weeks schedule.~      The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501.~     Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or~     pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or~     not patients are eligible for bevacizumab therapy.~      Preclinical and clinical findings that support this protocol are:~        -  CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines.~        -  Synergism was documented with CBP501/cisplatin in the preclinical studies with lung~          cancer cell lines.~        -  The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was~          suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of~          potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I~          trial, and the toxicity of the combination, primarily related to cisplatin, is~          manageable. It is expected that CBP501 and pemetrexed will display non-overlapping~          toxicity profiles in combination, given that hematological toxicity and gastrointestinal~          toxicity are the principal toxicity types of the latter.~        -  Given the acceptable safety of the cisplatin/ pemetrexed combination, it is anticipated~          that the addition of CBP501 to this combination can be evaluated without excessive risk~          in the phase II programs.~        -  The phase I study of CBP501 in combination with pemetrexed/cisplatin (phase I part of~          the mesothelioma program) did not show DLTs or evidence of enhancement of toxicities~          with the triplet combination. The RD of CBP501 25 mg/m², cisplatin 75 mg/m² and~          pemetrexed 500 mg/m² is currently in use in the phase II study with first line~          mesothelioma patients.~        -  Hints of activity were observed during the phase I study with CBP501 and cisplatin.~        -  No pharmacokinetics (PK) interaction was documented between cisplatin and CBP501.~   "
200158|NCT00942812|"~     Diarrhoeal diseases are still the major paediatric health concern worldwide, contributing for~     2.5 million annual deaths in children. Although the treatment of diarrhoeal illness as per~     the World Health Organization (WHO) guidelines brings about a considerable decline in the~     burden of the disease but there is still a lot to be done for this issue. Zinc~     supplementation along with Oral Rehydration Solution (ORS) has emerged as a potent approach~     to treat diarrhoea. It is believed that the children having zinc deficiency are at high risk~     of developing infectious diseases which eventually lead to a high burden of mortality.~      In order to prevent and effectively manage diarrheal episodes, it is important that water~     purification tablets, zinc and oral rehydration salt is always available in each household.~     Though, these products are easily available in the market separately, but are rarely~     available together in any household. If these products are made available in a single packet,~     it is likely to be an effective strategy in combating diarrheal diseases in the community.~   "
200159|NCT00942799|"~     This is a Phase I, open-label, multicenter, dose-escalation study designed to assess the~     safety and tolerability of Genz-644282, administered as an intravenous (IV) infusion, to~     patients with advanced malignant solid tumors. Each 28 day cycle of treatment will consist of~     3 consecutive weeks of treatment every 28 days(i.e., treatment will be administered on Days~     1, 8, and 15 every 28 days). Each 21 day cycle of treatment will consist of 2 consecutive~     weeks of treatment every 21 days(i.e., treatment will be administered on Days 1 and 8 every~     21 days). Treatment with Genz-644282 will continue until disease progression or unacceptable~     toxicity is observed. Approximately 110 patients will be enrolled in this study. Patients~     will be enrolled in escalating dose cohorts until the Maximum Tolerated Doses (MTDs) for the~     2 dosing schedules are established. To further evaluate safety, approximately 40 additional~     patients with advanced malignant solid tumors will be enrolled and treated at the MTDs (20~     for each dosing schedule) during an expansion phase.~   "
200160|NCT00942786|"~     The investigators hypothesize that the level of perioperative natriuretic peptides is~     associated with in-hospital and long term major adverse cardiac events.~   "
200161|NCT00942773|"~     The purpose of this study is to:~        -  Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.~   "
200162|NCT00942760|"~     Brain imaging tests are routinely used to detect the presence of a brain tumor or to evaluate~     the response to treatment. Sometimes the images obtained are not specific and the only way to~     establish a diagnosis is by obtaining a tissue sample. The hypotheses of the study is to~     determine if multimodal MR technique will provide tissue signatures that differentiate~     between tumor progression and treatment related necrosis in high grade glioma patients.~   "
200163|NCT00942747|"~     This is an open-label trial investigating the efficacy of temsirolimus in recurrent or~     refractory primary CNS lymphoma (PCNSL) after initial chemotherapy with a high-dose~     methotrexate containing regimen. 37 patients are planned to be treated with weekly infusions~     of 25mg Temsirolimus (first 3 patients) or 75mg Temsirolimus (all other patients) up to a~     maximum of 12 months. The trial is designed in two stages, if less than one of the first 12~     patients responds to treatment, the trial is stopped. In addition to efficacy, safety and~     penetration of temsirolimus into the cerebrospinal fluid will be investigated.~   "
200164|NCT00942734|"~     The goal of this clinical research study is to learn if RAD001 in combination with Tarceva~     (erlotinib hydrochloride) can help to control head and neck squamous cell cancer (HNSCC). The~     safety of this drug combination will also be studied.~   "
200165|NCT00942721|"~     This study will develop and test a Web-based program to treat women with postpartum~     depression.~   "
200166|NCT00942708|"~     This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for~     three months among patients with pulmonary arterial hypertension.~   "
200167|NCT00942695|"~     The objective of this study is to measure the energy value of pistachios in the human diet~     and study molecular mechanisms that may help explain the beneficial health effects of~     pistachios.~   "
200168|NCT00942682|"~     The purpose of this research study is to find out more about the combination of RAD001 and~     sorafenib such as the safest dose to use, the side effects it may cause, and if the drug is~     effective for treating neuroendocrine tumors.~   "
200169|NCT00942669|"~     The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip~     OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic~     (PSG) study.~   "
200170|NCT00942656|"~     The objectives of this study are to : 1) determine if vaccenic acid (trans-11-octadecenoic, a~     naturally occurring trans fatty acid isomer from ruminant animal products) raises LDL~     cholesterol in a quantitatively comparable manner as mixed trans fatty acid isomers from~     partially hydrogenated vegetable oils at 3% of energy intake, 2) determine if cis-9, trans-11~     conjugated linoleic acid (a naturally occurring polyunsaturated fatty acid from ruminant~     animal products) raises LDL cholesterol compared to a control diet, and 3) demonstrate that~     mixed trans fatty acid isomers from partially hydrogenated vegetable oil raises LDL~     cholesterol compared to a low trans fatty acid diet.~   "
200171|NCT00942643|"~     The investigators hypothesize that obstructive sleep apnea (OSA) may lead to increased~     formation/accumulation of advanced glycation ends (AGEs), and that the increase in AGEs is~     contributed in part by increased insulin resistance. The investigators further hypothesize~     that AGEs contribute to vascular endothelial damage and ultimately atherosclerosis in OSA.~      The objectives of this study are:~        1. To explore the relationship between insulin resistance and AGEs in OSA~        2. To study the relationship between AGE and vascular endothelial dysfunction in OSA~        3. To study the relationship between AGE and early atherosclerosis in OSA~   "
200172|NCT00942630|"~     In a prospective study the investigators perform repeated cholangioscopies in all patients~     that received percutaneous transhepatic biliary drainage (PTBD) for a variety of malignant~     and benign diseases. Endoscopic findings and their correlation with clinical features will be~     recorded prospectively. The impact on clinical decision will be evaluated.~   "
200173|NCT00942617|"~     Aspirin has been shown to reduce cardiovascular events in at risk individuals. Elucidation of~     mechanisms of aspirin resistance and a possible loss of effect of aspirin over time with~     chronic aspirin treatment necessitate a more precise method of measuring the release phase~     of platelet activation, including the release of dense granules from platelets.~   "
200174|NCT00942604|"~     The purpose of this study is to determine whether topical application of PEP005 is effective~     for the treatment of actinic keratoses.~   "
200175|NCT00942591|"~     Title: Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with~     relapsing-remitting multiple sclerosis treated with interferon-beta-1b SWiss Atorvastatin and~     Interferon-Beta 1b Trial In Multiple Sclerosis~      Short title: SWABIMS~      Study phase: Phase IIb study~      Study design: Multi-center, randomized, rater-blinded, parallel-group-study in Switzerland~      Investigational product: Atorvastatin 40mg every day (oral) plus Interferon-beta~      Reference product: Interferon-beta-1b 250mg given~      Indication: Relapsing-remitting multiple sclerosis (RR-MS)~      Study objectives: Comparison of efficacy, safety and tolerability of combination of~     Atorvastatin 40mg (per os) daily and Interferon-beta-1b e.o.d in patients with~     relapsing-remitting multiple sclerosis compared to monotherapy with Interferon-beta-1b e.o.d.~      Primary Endpoint: Proportion of patients with new T2 lesions after 15 months of treatment.~   "
200176|NCT00942578|"~     Background:~        -  Prednisone and docetaxel have been used successfully in treating patients with prostate~          cancer, either when used alone or in combination with other agents. Researchers believe~          that these anticancer effects can be increased by giving them in this specific~          combination.~        -  A previous study at the National Cancer Institute combined docetaxel and prednisone with~          bevacizumab and thalidomide. The results of this study were promising; however, most~          patients in the study required a dose reduction of thalidomide because of its side~          effects.~        -  Lenalidomide, a drug similar to thalidomide, may have less severe side effects. Based on~          previous studies, lenalidomide is well tolerated in patients with solid tumors when used~          alone or in combination with docetaxel, and it may be a good substitute for thalidomide.~      Objectives:~        -  To determine if lenalidomide is an appropriate and effective substitute for thalidomide~          in treating prostate cancer.~        -  To evaluate the safety and effectiveness of bevacizumab, lenalidomide, docetaxel, and~          prednisone as a prostate cancer treatment, and to study any side effects.~      Eligibility:~      - Men 18 years of age and older who have been diagnosed with metastatic prostate cancer that~     has not responded to standard treatment, including surgical removal of the testicles or~     treatment with androgen (sex-hormone) suppressing drugs.~      Design:~        -  Participants will have a complete medical history and physical examination before~          beginning the study.~        -  Patients will be treated with 21-day cycles with a combination of four drugs:~        -  (1) Docetaxel, which will be given into a vein for 60 minutes on the first day of each~          21-day cycle. Patients will take dexamethasone (a steroid agent) before and after taking~          docetaxel.~        -  (2) Prednisone, which will be taken by mouth daily.~        -  (3) Bevacizumab, which will be given through a vein over 30 to 90 minutes on the first~          day of each 21-day cycle following the infusion of docetaxel.~        -  (4) Lenalidomide, which will be taken by mouth during the first 2 weeks of each 21-day~          cycle. The dose of lenalidomide may be adjusted if side effects develop.~        -  Patients will also receive enoxaparin, a subcutaneous injection administered daily, to~          prevent blood clots and/or pegfilgrastim, a subcutaneous injection on day 2 of each~          cycle, to improve white blood cell counts, as directed by researchers.~   "
200177|NCT00942565|"~     Patient experience moderate to severe pain after abdominal surgery. This post-operative pain~     can also contribute to complications such as respiratory impairment, cardiovascular events,~     ileus, sleep deprivation and mood disturbance. Opioid based patient-controlled analgesia~     (PCA) is commonly employed but opioids have the side effects such as respiratory depression,~     nausea and vomiting, sedation, pruritus and urinary retention. Bowel motility can also be~     affected. Consequently alternative or adjunct analgesic medications without these~     side-effects have been investigated in order to reduce opioid consumption.~      Multimodal analgesia is a technique whereby a combination of analgesic drugs with different~     modes of action can be used to improve analgesia and decrease adverse effects by virtue of~     synergism. Postoperatively, with adjunctive analgesia, PCA morphine consumption as well as~     the side effects may be reduced. Non-steroidal anti-inflammatory drugs (NSAIDs) have been~     shown to be opioid sparing and decrease the adverse effects of PCA morphine. A recent review~     showed that acetaminophen combined with PCA could induce a significant opioid-sparing effect~     but the incidence of PCA morphine related side effects were not reduced.~      It is common nowadays to give oral analgesic supplements to post-operative patients on PCA~     morphine. Tramadol, an analogue of codeine, is one of the choices. However, some of the~     patients cannot tolerate the side effects such as nausea, drowsiness, sweating, postural~     hypotension and dry mouth. Combination of tramadol 37.5 mg and acetaminophen 375 mg, which~     has been used successfully to treat post-operative pain, may improve analgesic response with~     better tolerability.~      This study is to assess tramadol 37.5 mg and acetaminophen 375 mg combination on the efficacy~     of pain control, down stepping of morphine consumption and related adverse events with PCA~     use after open colorectal surgeries.~      Objectives:~      This study aims to compare and evaluate:~        -  The efficacy of tramadol/acetaminophen combination on postoperative pain relief after~          lower abdominal surgeries~        -  The effects of tramadol/acetaminophen combination on the consumption and the duration of~          PCA morphine use~        -  The adverse effects related to this regimen~        -  The effects on postoperative bowel function, tolerability of fluid and diet, ambulatory~          function, sleep, and duration of hospital stay~        -  The overall satisfaction of the patients~   "
200178|NCT00942539|"~     Lumbar puncture is one of the most common painful procedures performed on neonates in the~     Emergency Department (ED). The investigators will study in a randomized controlled trial, the~     efficacy of intravenous administration of a single dose of Midazolam in reducing pain and~     anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse~     sedation reactions. The investigators hypothesize that compared with placebo, single dose~     Midazolam would significantly decrease pain and anxiety and will have low rate of adverse~     reactions.~   "
200179|NCT00942526|"~     Anastomotic leakage is still to be a major cause of considerable morbidity and mortality~     after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of~     anastomotic leakage, including blood supply, graft tension, and comorbidity, have been~     performed, but few studies have produced strategies that have improved operative results.~     This study will be performed to identify prognostic variables that might be used to develop a~     strategy for optimizing outcomes after esophagogastrectomy.~   "
200180|NCT00942513|"~     Does the consumption of various combinations of mono and disaccharides (lactose, sucrose and~     fructose) and protein isolates (whey or soy) result in altered substrate absorption,~     substrate oxidation, and glucose regulation? This proposed research will provide data to~     determine the relative contribution of source of protein (whey vs soy) and carbohydrate~     (mono- and disaccharides) on the observed effects of dairy products on absorption, substrate~     oxidation and glucoregulation mechanisms that affect body composition.~   "
200181|NCT00942500|"~     The purpose of this study is to investigate the effects of postconditioning on myocardial~     reperfusion in patients with ST-segment elevation myocardial infarction.~   "
200182|NCT00942487|"~     Summary:~        -  Study title: Effects of Nebivolol on subclinical left ventricular dysfunction. A~          comparative study against Metoprolol. (ENESYS study)~        -  Study phase: 3~        -  Study design (parallel, cross-over, etc.), randomisation and blinding procedures, type~          of control (placebo or active): randomised, parallel, active-controlled, open label~        -  Study treatment(s)/drug(s): Nebivolol versus Metoprolol~        -  Patients:~             -  characteristics: patients with hypertension and left ventricular hypertrophy~             -  planned total number: 50~        -  Study duration:~             -  total enrolment period (months): 18~             -  treatment period (months): 6~             -  follow up period (months): 6~        -  Total study duration (months): 24~             -  Number of Centres: 1~             -  Country(ies): Romania (RO)~   "
200183|NCT00942474|"~     The purpose of this study is to assess the ability of the nerve access tool to facilitate~     nerve stimulation lead placement.~   "
200184|NCT00942461|"~     This study is designed to measure and compare the inflammatory response in laparoscopic and~     open colon cancer surgery~   "
200185|NCT00942448|"~     The present study is proposed to evaluate the efficacy and safety of single doses of~     Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute~     moderate-to-severe pain after dental impaction surgery.~   "
200186|NCT00942435|"~     The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for~     prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.~   "
200187|NCT00942422|"~     RATIONALE: Green tea extract contains ingredients that may prevent or slow the growth of~     monoclonal gammopathy of undetermined significance and/or smoldering multiple myeloma.~      PURPOSE: This phase II trial is studying how well green tea extract works in treating~     patients with monoclonal gammopathy of undetermined significance and/or smoldering multiple~     myeloma.~   "
200188|NCT00942409|"~     This is a Phase II, open label, fixed dose, repeat injection, single institution study.~     Eligible subjects will receive up to six doses of Ad-ISF35 injected directly into a selected~     lymph node under ultrasound guidance. The primary goal is to determine and monitor clinical~     and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.~   "
200189|NCT00942396|"~     Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography~     (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast~     cancer.~   "
200190|NCT00942383|"~     The purpose of this study is to investigate the potential for visualizing~     radiofrequency-induced (RFA) and microwave-induced (MWA) hepatic thermal ablation lesions~     using a novel, high resolution, and freehand ultrasound elasticity imaging method in human~     subjects.~   "
200191|NCT00942370|"~     The purpose of this study is to assess the delay between the detection (by~     mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough~     effort.~   "
200192|NCT00942357|"~     This randomized phase III trial studies carboplatin and paclitaxel to see how well they work~     with or without cisplatin and radiation therapy in treating patients with stage I-IVA~     endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after~     surgery may kill any tumor cells that remain after surgery. It is not yet known whether~     carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy~     in treating patients with endometrial cancer.~   "
200193|NCT00942344|"~     The purpose of this study is to evaluate the safety and efficacy of fixed combination of~     amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in~     reducing blood pressure. The study will investigate the dose response relationship for the~     combinations and monotherapies.~   "
200194|NCT00942331|"~     This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab~     to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating~     patients with urinary tract cancer that has spread to other places in the body. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with~     the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine~     hydrochloride and cisplatin are more effective when given with or without bevacizumab in~     treating patients with urinary tract cancer.~   "
200195|NCT00942318|"~     A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control~     despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous insulin~     infusion (CSII), using an external pump, could be a solution to improve diabetes control.~      The aim of this study is to compare, over a one-year period, the efficacy of CSII (with~     aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x 2/d~     and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen~     for at least 6 months, who didn't reach adequate target for glycemic at baseline (HbA1c>7~     -10%).~   "
200196|NCT00942305|"~     This is a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study of~     CMX001 administered once weekly for up to 11 weeks. Dosing will be initiated immediately~     following engraftment (between Days 14-30 post-transplant) to prevent/control CMV infection~     or prevent disease in R+ allogeneic stem cell transplant recipients.~   "
200197|NCT00942292|"~     The purpose of this study is to determine whether fish oils - a known source of omega-3 given~     intravenously (via a 'drip') will help cure secondary deposits in the liver from bowel~     cancer.~   "
200198|NCT00942266|"~     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin~     calcium, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known which dose of vorinostat is more~     effective when given together with combination chemotherapy in treating patients with~     metastatic colorectal cancer. PURPOSE: This randomized phase II trial is studying the best~     dose of vorinostat to see how well it works when given together with fluorouracil and~     leucovorin calcium in treating patients with metastatic colorectal cancer that has not~     responded to previous treatment.~   "
200199|NCT00942253|"~     Uremic etiology Restless legs syndrome (RLS) has been associated with poorer quality of life~     (QoL) compared to RLS-free counterparts mainly due to sleep deprivation factors. Exercise~     training in hemodialysis (HD) patients with RLS has been proven to be a safe approach in~     temporally ameliorating RLS symptoms similarly to the use of pharmacological treatment with~     dopamine agonists. However it not known whether the exercise anabolic stimulus and the~     dopamine agonist treatment could act synergistically for the improvement of physical~     functioning and muscle performance as well as in the amelioration of augmentation symptoms in~     hemodialysis patients with RLS.~   "
200200|NCT00942240|"~     The purpose of this study is to evaluate the safety and tolerability of repeated doses of a~     new investigational drug (ACU-4429) in healthy human subjects.~   "
200201|NCT00942227|"~     The purpose of this study is to determine the effectiveness of adding mechanical traction to~     standard physical therapy treatments for patients with low back pain.~   "
200202|NCT00942214|"~     Information from blood samples may help us for choosing the best treatment in future~     personalized medicine. Natalizumab (NTZ) a current treatment for MS can be used as a second~     line therapy if a suboptimal response to disease modifying drugs. When to introduce NTZ is~     not consensual. The investigators hypothesized that biological information could rationalize~     choice and thus designed a prospective open label trial to test biological markers before~     treatment.~   "
200203|NCT00942201|"~     Hypothesis: A 2-day course of oral dexamethasone is the superior option for the resolution of~     symptoms and prevention of relapse in the emergency department (ED) management of~     mild-moderate asthma exacerbations.~   "
200204|NCT00942188|"~     Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2~     diabetes.~   "
200205|NCT00942175|"~     The purpose of this study is to assess the potential effect and safety of multiple oral doses~     of dexlansoprazole, lansoprazole, omeprazole or esomeprazole, once daily (QD), on the~     steady-state pharmacokinetics and pharmacodynamics of clopidogrel, and to assess the safety~     of multiple doses of clopidogrel in healthy participants.~   "
200206|NCT00942162|"~     The objective of this study is to evaluate the clinical activity of the GSK2132231A~     immunotherapeutic in patients with MAGE-A3 positive unresectable metastatic melanoma~     presenting with the predictive gene signature.~   "
200207|NCT00942149|"~     This is a safety and pharmacokinetic study of single-dose daptomycin in infants > 48 hours~     and < 120 days of age with suspected systemic infections. The investigators will enroll a~     total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be~     performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6~     mg/kg of daptomycin will yield an AUC <740 mch*hr/mL.~   "
200208|NCT00942136|"~     GSK1349572 is an integrase inhibitor that is currently being evaluated for the treatment of~     HIV infection. The primary objective of this study is to determine whether the addition of a~     proton pump inhibitor, omeprazole, to GSK1349572 impacts the blood levels of GSK1349572. It~     will also evaluate if a high fat meal impacts the blood levels of GSK1349572. In addition,~     the safety, tolerability, and pharmacokinetics of single supratherapeutic (high) dose of~     GSK1349572 will be evaluated.~   "
200209|NCT00942123|"~     Metformin is the first line drug of choice for the treatment of type II diabetes. Lactic~     acidosis can develop as a side effect, especially when renal failure leads to drug~     accumulation. Lactic acidosis is usually attributed to an abnormal inhibition of hepatic~     lactate clearance.~      Growing evidence suggest that metformin can dose-dependently inhibit hepatocyte mitochondrial~     function. Whether a similar effect occurs in extra-hepatic human tissues remains unknown.~      The investigators hypothesize that mitochondrial dysfunction occurs during metformin~     intoxication even in tissues other than the liver, thus contributing to the development of~     lactic acidosis. The aim of this study is to investigate mitochondrial integrity in~     circulating platelets of patients with lactic acidosis due to metformin intoxication.~   "
200210|NCT00942110|"~     The purpose of this study is to examine postprandial glucose and lipid metabolism in patients~     with obstructive sleep apnea.~   "
200211|NCT00942097|"~     The purpose of this study is to evaluate the efficacy of homeopathic treatment in pregnant~     women with overweight and class I obesity with suspicion of a mental disorder.~   "
200212|NCT00942084|"~     Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in babies.~     Appropriate dosing of acyclovir is known for adults and children but acyclovir has not been~     adequately studied in full-term or premature neonates. HSV is a very serious infection in~     babies <6 months of age and often results in death or profound mental retardation. HSV leads~     to profound mental retardation in young infants because the virus attacks the central nervous~     system.~      The investigators hypothesize that the currently recommended dose of acyclovir is inadequate~     to produce adequate blood levels to combat herpes simplex infection. The investigators~     propose to study acyclovir levels in the blood of babies who are placed on acyclovir to treat~     a suspected HSV infection. This will allow them to determine the appropriate dose in~     premature infants. This is an unmet public health need because it is likely that the drug~     behaves differently in premature infants than it does in term infants and older children.~     Premature babies have more body water and less body tissue. Their kidneys are more immature~     and do not function as well as full term infants. Premature neonates are also at the greatest~     risk from herpes infection because they have poorly functioning immature immune systems.~     Early and appropriate treatment with acyclovir has resulted in improved outcome in term~     infants.~   "
200501|NCT00938314|"~     The purpose of this study is:~        -  To assess the neurological outcome in acute ischemic stroke patients treated with~          NTx®-265, when compared with patients given a placebo control.~        -  To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke~          patients.~   "
200213|NCT00942071|"~     This is an open label phase I study, to assess the safety of a novel influenza vaccine,~     MVA-NP+M1. All volunteers recruited will be healthy. Twelve volunteers will be administered~     with a single dose of 5 x 10^7 pfu of MVA-NP+M1 via the Intradermal (ID) route (group 1).~     Sixteen volunteers will receive Intramuscular (IM) MVA-NP+M1. The first 8 volunteers will be~     administered a single dose of 5 x 10^7 pfu of MVA-NP+M1 followed by a further eight receiving~     2.5 x 10^8 pfu of MVA-NP+M1 (group 2). The 3rd group will be split into 3 groups of 10~     volunteers in the age ranges 50-59, 60-69 and 70 and above and administered intramuscularly~     with a single dose of 1.5 x 10^8 pfu of MVA-NP+M1. Safety data will be collected. The~     secondary aim of this study will be to assess the cellular immune responses generated by each~     dose.~   "
200214|NCT00942058|"~     One third of patients with kidney cancer are diagnosed in the metastatic stage, and among~     patients with a localized form, about 30 to 40% will develop metastases after surgery.~      Medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or~     IL-2, or targeted therapies such as anti-angiogenic (anti-vascular endothelial growth factor~     (VEGF), anti-tyrosine kinase inhibitors and m-TOR). These treatments sometimes associated (or~     IL2 + INF or INF AntiVEGF) do allow for objective response in 15 to 30% of cases (net benefit~     of targeted therapies), but are carriers of potentially significant side effects and are very~     expensive. The treatment response is considered on imaging exams repetitive, costly and~     inconsistently reliable. A serum marker of tumor development would be particularly welcome.~      CA9 is an oncogene also know as CA IX, carbonic anhydrase 9 or MN/CA9. The gene encoding an~     oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX~     CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in~     tumor tissue can be used as a predictive marker of response to immunotherapy.~      In previous studies, the investigators tried to use CA9 to improve the differential diagnosis~     of kidney tumors using tumor biopsy or fine needle aspiration. More recently, the~     investigators have developed the ELISA and quantitative reat time polymerase chain reaction~     (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic~     kidney cancer. The investigators have thus shown that CA9 was overexpressed prior to surgery~     and that this expression disappeared after tumor ablation.~   "
200215|NCT00942045|"~     This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus~     in subjects who receive ACDF surgery at one or two levels. These subjects will present with~     degenerative conditions in the cervical spine that are amenable to surgical treatment and~     will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any~     other biologic product, during their ACDF operation. The ACDF procedure will be conducted~     with a radiolucent graft containment device such that progression of fusion can be adequately~     assessed via radiograph. Subjects will be followed for 24-months following surgery to~     determine the number of study subjects that are solidly fused at or before 24 months~     postoperatively, and to determine the mean time to fusion. This data will be compared to~     published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic~     Protein (BMP).~   "
200216|NCT00942032|"~     The aim of this observational study is to collect and evaluate the current clinical~     experience gained from the Hindfoot Arthrodesis Nail (HAN) for ankle and hindfoot fusions.~   "
200217|NCT00942019|"~     The investigators want to assess differences in lung function and bronchial inflammation of~     young smokers and non-smokers with (BMI > 30) and without obesity (BMI < 25)(4 patient~     groups). The aim of the study is to compare differences in lung function (VC, FEV1, VC/FEV1,~     metacholine challenge) and bronchial inflammation in relation with smoking history and levels~     of exhaled CO. For the latter the investigators will analyze the levels of IL-8, IL-6, TNF~     alpha and INF gamma and mRNA of LBP, TLR2 and TLR4 in sputum. Further, inflammatory markers~     e.g. low CRP and inflammatory cytokines levels in the blood will be investigated. The aim is~     to describe a early stage of chronic obstructive pulmonary disease caused by cigarette smoke~     in juvenile smokers, and the relationship between bronchial inflammation and obesity in~     adolescents.~   "
200218|NCT00942006|"~     The investigators will compare doxycycline and ceftriaxone in treatment of patients with~     suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that~     the efficacy and adverse effects of both antibiotics are comparable.~   "
200219|NCT00941993|"~     This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the~     effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine~     solution for provision of tympanic membrane anesthesia in patients who are indicated for an~     ear procedure requiring penetration of the tympanic membrane, including, but not limited to,~     myringotomy, tympanocentesis with culture or tympanostomy with tube placement.~   "
200220|NCT00941980|"~     This study is being conducted to determine the percentage of patients with solid spinal~     fusions after being treated with Osteocel Plus in a PLIF procedure. Due to the unique~     processing conditions, Osteocel Plus retains a high concentration of stem cells attached to~     the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will~     be comparable to published data for autograft. The Osteocel product family has already been~     used in approximately 20,000 cases worldwide.~   "
200221|NCT00941967|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. It is not yet known whether sorafenib tosylate is more effective when given with or~     without gemcitabine hydrochloride and oxaliplatin in treating patients with liver cancer.~      PURPOSE: This randomized phase II trial is studying sorafenib tosylate to see how well it~     works when given with or without gemcitabine hydrochloride and oxaliplatin in treating~     patients with locally advanced, unresectable, or metastatic liver cancer.~   "
200231|NCT00941837|"~     In this study, the investigators address the research question of whether palm olein will~     have a positive influence on plasma total homocysteine levels in human volunteers provided~     with high-protein diets formulated from common Malaysian foods.~      Hypothesis: There is a significant difference on the effects of the three experimental oils~     (palm olein, olive and coconut oil) on plasma tHy levels and the other markers of coronary~     heart disease (CHD) risk measured.~   "
234978|NCT00480155|"~     To assess the safety of a vaccine in healthy adults prior to the release of the vaccine~     (FluMist®) containing it.~   "
200222|NCT00941954|"~     Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical~     activity is a key factor driving this epidemic and it is therefore vital that workable~     methods of encouraging people to exercise and reducing inactivity are developed and tested if~     we are to stem the rising tide of diabetes.~      This cluster randomised controlled trial will investigate whether a person−centred group~     educational programme can increase walking activity and reduce the risk of developing~     diabetes in high−risk individuals identified in primary care settings. In total 804 patients~     will be recruited to the study. Physical activity levels, glucose control, incidence of type~     2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis~     over three years.~      This trial will be the first to test the feasibility, efficacy and value for money of a~     physical activity intervention aimed at reducing the risk of diabetes in a community setting~     in a multi−ethnic population in the UK.~      Primary research hypothesis: A pragmatic structured education programme aimed at promoting~     walking activity initiates long−term increases in physical activity in individuals identified~     through a risk score as having an increased risk of developing type 2 diabetes.~   "
200223|NCT00941941|"~     The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the~     treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used~     in India, the Desarda method is reported to offer superior outcomes such as minimal~     postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based~     repairs, it is a simple and affordable technique suitable for the resource-constrained~     communities. It is devoid of complications associated with foreign body implants. Early~     clinical outcomes which include acute groin pain, time to resumption of normal gait,~     operative time and complications will be assessed. Participants will be followed at 2 hours,~     3 days, 7 days and 14 days postoperatively.~      The investigators hypothesize that the mean postoperative acute groin pain score, or the mean~     postoperative day of return to normal gait is different in adult patients who undergo the~     non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein)~     technique of hernia repair.~   "
200224|NCT00941928|"~     The goal of this clinical research study is to learn if transferring the donor's NK cells, in~     combination with an antibody called epratuzumab and low-dose interleukin (IL-2), into your~     body can be done safely. Researchers want to find out if the infused NK cells will survive~     after the infusion and if the NK cell infusion helps to destroy cancer cells in the~     recipient's body and possibly to help control the disease.~      Primary Objectives:~      · Evaluate the feasibility of collecting an adequate number of natural killer (NK) cells from~     a donor and evaluate the safety of a haploidentical donor-derived NK cell infusion,~     Epratuzumab, and low-dose interleukin-2 (IL-2).~      Secondary Objectives:~        -  Quantification and persistence of the infused donor NK cell in vivo;~        -  Quantification and persistence of cytokine levels;~        -  Assessment of NK cell immunophenotype and function;~        -  Correlate above with anti-tumor effect.~   "
200225|NCT00941915|"~     The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute~     and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the~     prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period.~     The prostate is localized and the plan is reoptimized as needed prior to each treatment.~   "
200226|NCT00941902|"~     Soluble secreted proteins that are expressed uniquely in specific organs and whose formation~     of secretion is regulated by disease states are excellent markers for the disease. This is~     because the disease can be diagnosed by simply measuring the levels of the secreted protein~     in serum. A soluble form of the asialoglycoprotein receptor could be a promising candidate~     for such marker in the case of liver fibrosis secondary to steatohepatitis for which the~     existing markers are not satisfactory. The human asialoglycoprotein receptor (ASGPR) is~     expressed only in hepatocytes. The H2a alternatively spliced variant of the ASGPR H2 subunit~     differs from H2b variant only by the presence of an extra pentapeptide. EGHRG, in the~     exoplasmic domain next to the membrane-spanning segment. H2a is rapidly cleaved to a36 kDa~     fragment, comprising the entire ectodomain, which is secreted. H2a does not participate in a~     membrane bound receptor complex with H1 as in the case for H2b and thus it is not a subunit~     of the receptor but a precursor for a soluble secreted form of the protein (sH2a). Although~     H2a is a type II transmembrane protein, signal peptidase is probably responsible for the~     cleavage to the soluble form.~      The objective in this research proposal is to study the association between the level of~     sH2a. in the serum and the severity of fibrosis in steatohepatitis in patients undergoing~     bariatric surgery due to morbid obesity.~      The existence of sH2a in normal human serum is at very constant levels. On the other hand the~     membrane ASGPR (expressed exclusively in hepatocytes) is profoundly down - regulated in liver~     cancer and cirrhosis. The investigators will analyze the levels of sH2a in serum from~     patients with steatohepatitis in different stages of fibrosis and compare with healthy~     subjects. A possible early down-regulation of sH2a in fibrosis may prove to be a valuable~     diagnostic tool.~   "
200227|NCT00941889|"~     The primary objective of this pilot study is to evaluate the effect of the HPV vaccine~     Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.~   "
200228|NCT00941876|"~     HIV positive women and couples have broad reproductive health needs that are not always met~     within HIV services. The integration of family planning (FP) services into Tanzania's HIV~     Care and Treatment Clinics (CTC) will address the fertility desires of CTC clients and~     ultimately result in the reduction of unintended pregnancies and HIV incidence. One strategy~     for integrating FP and CTC services is to use a facilitated referral model. Facilitated~     referrals are enhanced referrals for additional services that have been used in other~     settings and which are the preferred intervention strategy the Government of Tanzania would~     like to pilot test. This study will evaluate the feasibility, effectiveness, and costs of~     implementing a facilitated referrals intervention by examining FP use among female clients~     attending HIV/AIDS Care and Treatment Centers. This study will measure whether there is a~     reduction in unmet need for contraception among female CTC clients after the facilitated~     referral integration intervention has been implemented.~   "
200229|NCT00941863|"~     The primary objective of the study was to define the safety profile and maximum tolerated~     dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy~     in patients with advanced, refractory solid tumors.~      The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these~     patients being treated with sorafenib in combination with paclitaxel and carboplatin.~   "
200230|NCT00941850|"~     Patients are randomised to receive ongoing optimised device and medical therapy or triple~     ventricular site resynchronisation. The hypothesis states that patients receiving triple-site~     resynchronization will exhibit a better response.~   "
200502|NCT00938301|"~     The purpose of this first in human (FIH) study is to investigate the safety, tolerability,~     pharmacokinetics ( how the body handles the drug) and pharmacodynamics (how the drug affects~     the body) of PF-04455242-01 in healthy adult volunteers.~   "
200232|NCT00941824|"~     Mycophenolate acid (MPA) has been developed and approved in combination with cyclosporine and~     has been used in kidney transplantation for more than a decade. At present, combination of~     tacrolimus and mycophenolate acid tends to be considered as the standard of care for~     maintenance immunosuppression in kidney transplantation. Mainly due to a different effect on~     the entero-hepatic recycling pathway, cyclosporine and tacrolimus differently interfere with~     MPA clearance. When used with tacrolimus, MPA dosage has thus to be adjusted and cannot be~     extrapolated from what is recommended for a cyclosporine-based treatment. However, there is~     currently no clear guideline for MPA dosing when this drug is used in combination with~     tacrolimus. This is potentially detrimental for patients since under-or overexposure of MPA~     has been clinically linked to the outcome of transplantation.~      The purpose of this study is to pharmacologically validate an original MPA dosing regimen in~     combination with tacrolimus within the three months post-kidney transplant. This regimen~     consists in an intensified dosing of mycophenolate sodium during the earliest period of~     transplantation in order to rapidly reach the appropriate MPA blood exposure followed by a~     gradual decrease in dose in order to prevent MPA overexposure.~   "
200233|NCT00941811|"~     The occurance and clinical course of human papillomavirus (HPV)-induced lesions is largely~     determined by the nature of the cellular immune defense generated. Even tough both genital~     warts and vulvar intraepithelial neoplasia (VIN) are HPV-associated genital lesions they~     differ in their risk of malignant progression. Imiquimod (IMQ) is a topically applied~     Toll-like receptor (TLR) 7 agonist that has been approved for the treatment of superficial~     (pre-) carcinomas of the skin (basal cell carcinomas, actinic keratosis) and HPV-associated~     lesions (genital warts). It acts by activation of the immune system exerting anti-tumor and~     anti-viral properties. The aim of the study is to evaluate the mechanisms of IMQ treatment~     and to analyze the differences in HPV-affected and non affected tissue at cellular and~     molecular level as determined by immunofluorescence stainings and real time PCR,~     respectively.~   "
200234|NCT00941798|"~     Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose~     combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an~     inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The~     objective of this safety trial was to assess the effect of treatment on the incidence of~     serious asthma exacerbations, defined as asthma related hospitalization and/or intubation~     and/or death. This was an event driven trial.~   "
200235|NCT00941785|"~     The aim of the study is to determine whether piperaquine plus dihydroartemisinin (DHA-PQ) is~     as effective, and better tolerated, than sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ),~     when used for seasonal Intermittent Preventive Treatment (IPT) to prevent malaria in children~     aged 3 to 59 months in Bobo-Dioulasso, Burkina Faso and to determine the pharmacokinetics of~     piperaquine in children.~   "
200236|NCT00941772|"~     The purpose of the study is to determine if ultrasonography is an adequate means for~     confirmation of nasogastric tube placement and that ultrasonography is more time efficient~     than radiography confirming nasogastric tube placement.~   "
200237|NCT00941759|"~     The purpose of this study is to study patients presenting with stage IV breast cancer. Stage~     IV means that the breast cancer has spread to another part of the body outside the breast.~     This study is important because in different parts of the country some patients are being~     offered surgical treatment for the breast tumor and some are not. The doctors do not know if~     surgery for the breast tumor is helpful in patients with stage IV breast cancer. The doctors~     will collect information about the patient and their treatment to learn more about how~     patients and doctors make treatment decisions. The doctor will also collect blood samples and~     tissue samples for laboratory studies to learn more about tumors that have spread to other~     parts of the body.~   "
200238|NCT00941746|"~     The purpose of this study is to evaluate the safety and tolerability of a single intravenous~     dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring~     substance, nerve growth factor (NGF).~   "
200239|NCT00941733|"~     This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with~     critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of~     the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular~     procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard~     (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with~     pre-study, post-study, and follow-up evaluations.~   "
200240|NCT00941720|"~     RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the~     growth of cancer cells by stopping them from dividing or killing them. An autologous stem~     cell transplant may be able to replace the blood-forming cells that were destroyed by the~     chemotherapy.~      PURPOSE: This phase II trial is studying how well giving busulfan together with~     cyclophosphamide followed by an autologous stem cell transplant works in treating patients~     with multiple myeloma.~   "
200241|NCT00941707|"~     The purpose of this study is to evaluate the efficacy, tolerability and safety of~     JNJ-38518168 compared with placebo in adult participants with active rheumatoid arthritis~     (long time systemic disease of the joints, marked by inflammatory changes in the synovial~     membranes and bones) despite methotrexate (MTX) therapy.~   "
200242|NCT00941694|"~     Asthma self-management is an effective way to improve the outcomes of patients with asthma.~     However, to be most effective these interventions should be targeted and designed toward a~     specific population or group. There is currently no asthma self-management intervention~     directed towards older adults. The hypothesis is that a 6-session asthma self-management~     intervention will improve the outcomes of older patients with asthma.~   "
200243|NCT00941681|"~     This study is designed to understand the pharmacokinetics of different oral formulations of~     CK-1827452 being considered for future studies in patients with heart failure. This study~     will compare the pharmacokinetics and safety and tolerability of both modified-release (MR)~     and immediate-release (IR) oral formulations of CK-1827452.~   "
200244|NCT00941668|"~     The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice~   "
200257|NCT00941499|"~     The goal of this clinical research study is to find the best combination of oxaliplatin,~     bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with~     advanced cancer that has spread to the liver. Different combinations of these drugs will be~     used, and the safety of all drug combinations will also be studied.~   "
200245|NCT00941655|"~     Background:~        -  Gastric (stomach) cancer is a rare cancer. In most cases, by the time it has been~          diagnosed it has spread to other organs in the body and the chance of a cure is very~          small. The standard treatment for gastric cancer is a combination of chemotherapy drugs.~        -  Researchers are interested in finding out if surgically removing all tumors before~          beginning chemotherapy for stomach cancer can slow or halt its spread better than giving~          chemotherapy alone.~      Objectives:~      - To determine whether tumor removal surgery followed by chemotherapy is more effective in~     treating gastric cancer than chemotherapy given alone.~      Eligibility:~      - Patients 18 years of age and older who have been diagnosed with gastric cancer.~      Design:~        -  All patients will undergo an initial physical examination, blood tests, imaging scans,~          and a laparoscopy to determine the extent of the disease.~        -  Half of the participants will be assigned to have surgery first and then chemotherapy;~          the other half will be assigned to have chemotherapy alone.~             -  The surgery-plus-chemotherapy group will have major surgery to remove all tumors in~               the stomach and abdominal area, followed by a recovery time of up to 4 weeks.~               Chemotherapy will begin 6 to 8 weeks after surgery.~             -  The chemotherapy-only group will begin treatment within 2 weeks of laparoscopy.~        -  All patients will receive four chemotherapy drugs: 5-Fluorouracil, leucovorin,~          oxaliplatin, and irinotecan. The drugs are given intravenously over 2 days every 2 weeks~          (one cycle) for 12 cycles (about 6 months), either at the National Institutes of Health~          (NIH) Clinical Center or at home with a referring oncologist. Patients in the surgery~          group who have tumors in the peritoneum will receive an additional set of chemotherapy~          drugs in a separate treatment.~        -  During the chemotherapy cycles, patients will provide blood samples approximately once a~          week and will have physical examinations and scans on a regular basis.~        -  Patients will return to the NIH Clinical Center for follow-up visits about every 4~          months for 2 years, then every 6 months for 3 years and yearly thereafter.~   "
200246|NCT00941642|"~     Lovaza is the only fish oil supplement approved by the FDA. It is available by prescription~     for the treatment of hypertriglyceridemia (> 500 mg/dl). The primary mechanism appears to be~     a reduction in hepatic production of triglycerides. Also decreases the hepatic production of~     very low density lipoprotein (VLDL). There also may be antioxidant properties as well. The~     thought behind using Lovaza as a treatment for non-alcoholic fatty liver disease (NAFLD) is~     two fold. It would help in the decrease production of triglycerides by the liver and have~     antioxidant properties decreasing the production of free radicals in the liver. In doing so,~     steatohepatitis, fibrosis, and perhaps cirrhosis and liver cancer would be prevented.~   "
200247|NCT00941629|"~     The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely~     via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF)~     treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related~     stressor (i.e., combat, sexual assault, non-combat physical assault). The secondary objective~     is to determine if patients' ratings of PTSD symptoms, affect, social adjustment, therapy~     alliance, treatment satisfaction and therapist satisfaction, are equivalent between~     service-delivery conditions (TMH vs. FTF). A final objective is to develop web-based practice~     assignments to assist participants in the TMH condition with treatment adherence (completion~     of the between- session practice assignments).~   "
200248|NCT00941616|"~     The aim of this study is to assess the pharmacokinetics (PK), efficacy, and safety of~     Biostate® in subjects with Von Willebrand Disease (VWD).~      Pharmacokinetic Component:~      PK parameters will be determined from a subgroup of subjects. Subjects who complete the PK~     component will subsequently continue in the efficacy component of the study, either~     continuing on a previously established prophylaxis regimen or continuing to receive on-demand~     treatment with the occurrence of non-surgical bleeding (NSB) events.~      Efficacy Component:~      Three treatment arms are defined for the efficacy component of the study. (1) Subjects who~     are currently being treated on a set prophylaxis regimen with a VWF product at the time of~     study entry will be enrolled in the Prophylaxis arm. (2) Subjects not being treated on a~     set prophylaxis regimen at the time of study entry who require a VWF product for the~     treatment of NSB events will be enrolled in the On-demand arm and commence using Biostate~     in the treatment of NSB events. (3) Subjects enrolled in the On-demand arm have the~     possibility to enter the Cross-over to Prophylaxis arm to receive an additional 12 months~     of prophylactic treatment.~   "
200249|NCT00941603|"~     The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the~     reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of~     treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or~     mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high~     density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The~     safety of SCH 900271 in this participant population will also be evaluated.~   "
200250|NCT00941590|"~     The purpose of this study is to assess clinical outcome in patients with tick borne~     encephalitis.~   "
200251|NCT00941577|"~     To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in~     subjects with mild asthma inhaling an allergen.~   "
200252|NCT00941564|"~     The objective is to assess the comparative calcium absorption and gastrointestinal (GI)~     tolerance in healthy normal term infants fed two commercially available powdered milk-based~     formulas which contain different fat blends.~   "
200253|NCT00941551|"~     The aim of this study was to compare the prevalence of recurrent nodular goiter in the~     contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral~     multinodular goiter receiving versus not receiving prophylactic levothyroxine treatment~     postoperatively in a five-year follow-up of a randomized study~   "
200254|NCT00941538|"~     Compared with the early diagnosis rate and the mortality rate between the patients of~     nasopharyngeal carcinoma (NPC) from the screening group and the control group, new screening~     protocol is conducted into high-risk population in Guangdong Province, China. Meanwhile, we~     also perform epidemiological surveys of the screening population to acquire the baseline~     information. Through analyzing the risk factors, this study can provide a population-based~     prospective evidences to better understand the reasons of NPC onset in high-risk population.~   "
200255|NCT00941525|"~     The purpose of this study is to determine whether 24-hour fluctuation of intraocular pressure~     (IOP) is associated with central corneal thickness (CCT) in subjects with ocular hypertension~     or open angle glaucoma and in age-matched controls. Also to evaluate whether mean IOP~     reduction as a response to latanoprost (0.005% Xalatan) is associated with CCT, after a~     4-weeks period of treatment.~      Also, to evaluate whether 24-hour fluctuation of IOP is associated with corneal hysteresis~     (CH) measured by Ocular Response Analyzer (ORA).~   "
200256|NCT00941512|"~     This study was designed to gather digital pictures of the cervix and correlate it to its~     histopathology, and then use those relationships to teach a computer how to objectively find~     cervical dysplasia and cancer.~   "
200258|NCT00941486|"~     The objective of this study is to evaluate the efficacy of FST-100 (0.1% dexamethasone)~     Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.~   "
200259|NCT00941473|"~     To evaluate for the effect of corticosteroid epidural injections on bone mineral density in~     postmenopausal women. Candidates for the study: Post menopausal women between the ages of 55~     and 80. No history of bone disease. No thyroid/parathyroid disorder. not used injected or~     oral steroids in the last year. No recent smoking.~      The purpose is to identify any significant change in bone mineral density with the use of~     epidural steroid injections. This may implicate the need for patient counseling regarding~     this possible side effect and the possible use of preventive measures to avoid this adverse~     effect.~   "
200260|NCT00941460|"~     For patients with progressive or recurrent glioblastoma there is no standard therapy. One~     strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done~     by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity.~     In study arm A patients receive temozolomide for one week, followed by a week without~     temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a~     week without temozolomide. The regimen that is less toxic will be selected for further~     evaluations.~   "
200261|NCT00941447|"~     The purpose of this investigation is to conduct a 12-week study to compare the effects of a~     self-regulation intervention (SR), in which participants will self-monitor their blood~     glucose (BG) and adjust dietary intake and physical activity through the use of current~     dietary and physical activity guidelines to help regulate their BG, to an education and~     self-monitoring only intervention (SM), on blood glucose, self-efficacy, and diabetes~     self-management activities.~   "
200262|NCT00941434|"~     Malnutrition is the leading cause of death in children in developing countries, especially~     Pakistan. According to World Health Organization about 60% of all deaths, occurring among~     children aged less than five years in developing countries, could be attributed to~     malnutrition.~      Community-based therapeutic care attempts to maximize population-level impact through~     improved coverage, access, and cost-effectiveness of treatment. Such community-based~     nutrition packages can provide effective care to the majority of acutely malnourished~     children as outpatients, using techniques of community mobilization to engage the affected~     population and maximize coverage and compliance. Children with SAM without medical~     complications are treated in an outpatient therapeutic program with ready-to-use therapeutic~     food and routine medications.~      The Ready-to-use Therapeutic Food (RUTF) and Fortified Supplementary food has revolutionized~     the treatment of moderate and severe malnutrition. The advantage of these commodities is that~     they are ready-to-use paste which does not need to be mixed with water, thereby avoiding the~     risk of bacterial proliferation in case of accidental contamination.~   "
200263|NCT00941421|"~     The purpose of this study is to determine the equivalence or not of diagnosis ability of~     oesophagal videocapsul versus oeso-gastro-duodenal fiber endoscopy in the screening of~     oesophagal varix.~   "
200264|NCT00941408|"~     This protocol aims to create a tissue bank of breast tumors obtained at the time of diagnosis~     for the identification of biomarkers for diagnosis, prognostication, and prediction of~     treatment response in breast cancer. While tissue banks now exist in major hospitals in~     Singapore to collect tumor specimens at the time of surgery, specimens collected at surgery~     from patients who had undergone pre-operative treatment represent a post-treatment sample and~     not a baseline, untreated sample. Such samples are intrinsically different from untreated~     samples, and have to be analyzed separately from untreated samples. However, they remain~     valuable samples, particularly if a pre-treatment sample has been obtained, providing paired~     pre- and post-treatment samples, which could provide valuable information on~     treatment-related tumor biomarker changes. A tissue bank comprising of samples collected~     during the diagnostic core biopsy thus represents a valuable supplement to existing tissue~     banks.~      Approximately 10-20% of patients diagnosed with non-metastatic breast cancer will require~     neoadjuvant chemotherapy. In addition, future clinical trials may include~     'window-of-opportunity' studies during which biological therapy is administered for a short~     period (2-3 weeks) while an operable breast cancer patient is awaiting definitive surgery.~     The majority of early-stage breast cancer patients would be eligible for such trials,~     allowing the rapid recruitment of breast cancer patients. When coupled with analysis of~     surrogate markers of response (eg apoptosis, anti-angiogenic effects, etc), these unique~     clinical trials could provide valuable insights into the biological effects of new~     therapeutic agents in evaluation.~   "
200265|NCT00941395|"~     Objectives:~      This study will help to establish the feasibility of a new smoking cessation and prevention~     intervention including two new modules addressing alcohol use and depression. In addition, we~     will demonstrate the feasibility of a smoking prevention website. Both cessation and~     prevention programs will be tailored to the needs of culturally diverse urban (University of~     Houston) and rural (Texas A&M) university campuses.~   "
200266|NCT00941382|"~     The aim of this study is to evaluate the effect of sibutramine and metformin combination~     therapy in comparison with sibutramine or metformin monotherapy over weight, adiposity,~     glucose metabolism and inflammatory state in obese patients.~   "
200267|NCT00941369|"~     Primary Objective:~      To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin~     on a composite diabetes related quality of life score (DRQoL).~      Secondary Objective:~      A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn~     basal insulin from baseline to endpoint in terms of:~        -  Glycaemic parameters: 7 blood glucose profiles~        -  Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia~        -  Change in lipid status~   "
200268|NCT00941356|"~     Trial Objectives:~      Primary objective:~        -  To evaluate the efficacy of Bio-K+CL1285® in patients with Methicillin-Resistant S.~          aureus (MRSA) nasal colonization by comparing the MRSA decolonization following either~          Bio-K+CL1285® or placebo treatment.~      Secondary objective:~        -  To evaluate the safety profile of Bio-K+CL1285®.~   "
200269|NCT00941343|"~     Primary Objective:~        -  To assess the sexual function of Benign Prostatic Hyperplasia patients~      Secondary Objective:~        -  To evaluate the association between Lower Urinary Tract Symptoms severity and sexual~          disorders~        -  To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic~          Hyperplasia patients on XATRAL 10mg OD among the different regions~        -  To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the~          International Index of Erectile Function (IIEF-5)~        -  To assess the onset of action of XATRAL 10mg OD~        -  To assess the peak urinary flow rate~        -  To assess the safety and the tolerability of XATRAL 10mg OD~   "
200270|NCT00941330|"~     The patients are being asked to take part in this study because they have a hormone~     receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their~     doctor has told them that they have an option to receive chemotherapy or hormonal therapy~     before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and~     cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor~     and allow them to preserve the breast or have less extensive surgery on their breast.~   "
200271|NCT00941317|"~     Based on manufacturer testing, no major difference in drilling condition is expected in this~     study compared to the drilling conditions previously established. However clinical testing is~     needed to establish optimal drilling conditions to be used for further development in both~     unaffected and affected parts of the nail. The aim of this study is to determine the optimal~     drilling condition that could be used in future studies of this device in combination with~     topical treatment for onychomycosis.~   "
200272|NCT00941304|"~     The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl)~     buccal film in the treatment of dental pain.~   "
200273|NCT00941291|"~     The purpose of this study is to evaluate the role of cataract surgery and cystoid macular~     edema (CME) on reopening of idiopathic macular holes (IMH).~   "
200274|NCT00941278|"~     PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical~     administration to the skin, and is being studied for the treatment of cutaneous skin~     disorders, specifically psoriasis and atopic dermatitis. This phase 2 efficacy and safety~     study will assess topical PH-10 applied once daily to areas of mild to moderate plaque~     psoriasis.~   "
200275|NCT00941265|"~     The investigators have been offering computer assisted therapy of aphasia (CAT) as a~     complement to traditional treatments to aphasia patients of the Service of~     Neurorehabilitation for some years. The investigators have shown its efficacy in~     hospitalised patients with recently acquired aphasia.~      In addition to studies stressing the importance of treatment intensity, several studies~     suggest that pharmacological treatment can also improve recovery after a cerebral lesion. The~     underlying idea is that the administration of medication influencing the system of~     neurotransmitters can play a role in functional recovery. Studies have assessed mainly~     substances acting on the dopaminergic (amphetamine and bromocriptine) and GABAergic system~     (piracetam).~      The main objective of the present study concerns the evaluation of the effects of levodopa on~     recovery of anomia in patients with aphasia. In particular, the investigators use CAT to~     control intensity and quality of therapy and they will assess whether the administration of~     levodopa promotes recovery.~      In each patient, two periods of anomia therapy with CAT, each performed with a different word~     list, will be compared. In addition to speech therapy, each period will be associated with~     the administration of either levodopa and benserazide (Madopar ®), or placebo. Evaluations at~     baseline and after each treatment period will be performed with the material and denomination~     battery~   "
200276|NCT00941252|"~     The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and~     persistent CIN 2 represents conisation. Surgical treatment can cause perioperative~     (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor)~     complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%.~     Imiquimod is an immunomodulating drug, that has been reported to be effective in human~     papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal~     intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present~     randomised, placebo controlled, double blind study evaluates the efficacy of a topical~     treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.~   "
200277|NCT00941239|"~     The purpose of this study is to determine the gastric tolerability and the pharmacokinetics~     of an extended release metformin compared with an immediate release metformin in healthy~     subjects.~   "
200278|NCT00941226|"~     Cerebral Palsy (CP) is characterized by a sensory-motor deficiency, involving disturbance of~     muscle tone, posture and voluntary movement. Children who are afflicted need special intense~     care for their carers~   "
200279|NCT00941213|"~     This study was undertaken to investigate the effect of using ultrasound scissors in the~     preparation for Thoracoscopic Ventral Spondylodesis. Quantity of bleeding and the duration of~     operation in Thoracoscopic Ventral Spondylodesis are compared to the preparation with~     monopolar electrosurgery.~   "
200280|NCT00941200|"~     Aims of Research Proposal:~        1. To build a DNA bank in association with a comprehensive database of treatment outcomes~          and toxicities of cancer patients.~        2. To carry out genotyping of potential candidate genes in relation to specific anti-cancer~          agents and to correlate genotype with treatment outcomes and toxicities.~      The investigators hypothesize that genetic variations between different individuals and~     ethnic groups may account for inter-individual and inter-ethnic differences in treatment~     response and toxicities to anti-cancer therapy. The understanding of the contribution of~     these genetic variations may help to individualize therapy to optimize treatment outcomes and~     reduce toxicities. Patients will be recruited from the National University Hospital Cancer~     Centre. Any individual aged 18 or above who has been diagnosed with cancer is eligible. 20 ml~     of blood will be collected from each subject for DNA extraction and pharmacogenetics~     analysis. At the time of recruitment, demographic characteristics, cancer history, and past~     and present cancer treatment history of the study subject will be collected. The patients'~     progress will be followed up periodically (approximately every 6 months) through the medical~     records, and subsequent cancer treatments, progression of cancer, and survival outcome will~     be updated. Follow-up will occur until death. Important treatment information that will be~     collected include the drug regimen, drug doses, intent of treatment, aematologic and~     non-haematologic toxicities, and hospitalization episodes that may be related to treatment.~     Known functional single nucleotide polymorphisms (SNPs) of drug metabolizing enzymes,~     transporters and targets of different anti-cancer agents will be characterized. More~     comprehensive genotyping will be carried out in 'outliers' who experience exceptional~     toxicity or biological response to identify novel functional SNPs using high throughput~     sequencing techniques. Correlation will be made between genotype and treatment-related~     outcomes (tumor response, progression-free survival) and toxicities. For selected patients,~     lymphoblastoid transformation will be carried out to maintain an infinite supply of DNA.~   "
200281|NCT00941187|"~     The purpose of this monocentric, preliminary study is to assess the evolution of pulmonary~     capillary blood volume (Vc), measured by the double diffusion nitric oxide/carbon monoxide~     (NO/CO) method (Guenard et al.; Respir Physiol 1987), from the starting of the anticoagulant~     therapy to 6 months after, and to search correlations with the evolution of clinical (dyspnea~     and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic~     (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung~     scan data.~   "
200282|NCT00941174|"~     The objective of this study is to determine whether the intact human colon with an unaltered~     microflora distribution absorbs folate and to what extent it is absorbed into the systemic~     circulation using a dual/oral intravenous route. This will elicit an understanding of colonic~     folate absorption and metabolism.~   "
200284|NCT00941148|"~     The aim of the study is to show that treatment with Glargine will lead to an improvement in~     beta cell function especially within times of maximal beta cell stress occurring after a~     meal. For this reason three different standardized test meals (breakfast, lunch, dinner) will~     be performed and the postprandial secretion of intact proinsulin levels will be measured.~     These measurements will be performed with patients treated in combination with metformin and~     insulin glargine versus metformin plus NPH insulin (within the core study) and if significant~     difference is observed, with a third treatment arm with metformin plus insulin detemir.~      Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours~     after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin~     levels of metformin plus NPH insulin.~   "
200285|NCT00941135|"~     To evaluate the progression free time in patients with completed or partial response > 30%~     evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin,~     5-FU) treated with RT + Cetuximab over 2 years.~   "
200286|NCT00941122|"~     1.To assess whether the Elution swab (ESwab) is superior to Amies transport swabs for the~     detection of Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant~     Enterococci (VRE) in colonized patients and to determine whether nasal cultures alone is~     sufficient for detection of MRSA isolates in hospitalized patients. 2.To assess patient~     comfort in the use of the ESwab vs. Amies Transport swab for screening patients for~     methicillin resistant Staphylococcus aureus and vancomycin-resistant Enterococcus.~   "
200287|NCT00941109|"~     The purpose of this study is to determine how the body absorbs decitabine when taken orally~     in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral~     dose.~   "
200288|NCT00941096|"~     The purpose of this study is to examine the ocular hypotensive effect of Bimatoprost and the~     potential additional effect of the Bimatoprost/Timolol fixed combination in eyes with ocular~     hypertension, primary open angle glaucoma or exfoliation glaucoma.~   "
200289|NCT00941083|"~     A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically~     and immunologically. Moreover, it will be associated with significant improvements in the~     lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a~     day (QD) will perform as well as RAL twice a day (BID).~   "
200290|NCT00941070|"~     This phase II trial is studying how triapine and cisplatin given together with radiation~     therapy works in treating patients with cervical cancer or vaginal cancer. Triapine may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving triapine together with cisplatin may make~     tumor cells more sensitive to radiation therapy.~   "
200291|NCT00941057|"~     Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after~     administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest~     and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg~     Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium~     after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg~     Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing~     0.451 mg levomefolate calcium~   "
200292|NCT00941044|"~     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA~     delivers assistance to spontaneous breathing based on the detection of the electrical~     activity of the diaphragm. The investigators will study the effects of non-invasive NAVA in~     respiratory muscle unloading in healthy volunteers.~   "
200293|NCT00941031|"~     The purpose of the study is to determine whether, in patients with moderate to severe~     plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis~     symptoms and the extent to which the patient's body area is affected by the disease (compared~     to placebo).~   "
200294|NCT00941018|"~     This study is being conducted to determine the safety, tolerability, pharmacodynamics and~     pharmacokinetics of RX-10001.~   "
200295|NCT00941005|"~     Introduction: Current rates of postoperative nausea and vomiting (PONV) experienced by~     outpatient surgery patients are as high as 20-30%. Electroacustimulation (EAS) therapy has~     been demonstrated to be effective in controlling these symptoms, but trials identifying their~     efficacy in the outpatient surgery population are lacking. This study integrates conventional~     pharmacotherapy with alternative medicine in prevention of PONV.~      Materials and Methods: One hundred twenty two patients undergoing surgery procedures at an~     outpatient surgery center were randomized to two treatment arms. The first arm was~     standardized pharmacologic PONV prevention typical for patients undergoing outpatient~     surgery, while the second arm employed the use of ReliefBand, an FDA-approved~     electroacustimulation (EAS) device with pharmacologic treatment to relieve symptoms of PONV~     and pain. EAS is a derivative of acupuncture therapy that uses a small electrical current to~     stimulate acupuncture points on the human body and is thought to relieve nausea, vomiting and~     pain. Outcomes measured were post-op questionnaires evaluating pain and nausea symptoms,~     emetic events, the need for rescue medications and the time to discharge.~   "
200296|NCT00940992|"~     To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients~     with rosacea.~   "
200297|NCT00940979|"~     The purpose of this study is to prove a reduction of postoperative wound infections after~     direct preoperative use of a microbial sealant in the form of Integuseal for vascular~     procedures on lower extremities.~   "
200298|NCT00940966|"~     The purpose of this study is to determine the effectiveness of two different non-energy~     restricted controlled carbohydrate programs with the American Diabetes Associations' diet on~     glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic~     syndrome, a constellation of symptoms associated with the development of type 2 diabetes and~     cardiovascular disease.~   "
200299|NCT00940953|"~     The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide +~     Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients~     with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.~   "
200503|NCT00938288|"~     The aim of this study is to determine the pharmacokinetics, safety and tolerability of~     KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.~   "
200300|NCT00940940|"~     Varicella zoster virus is part of the herpesvirus group and causes chickenpox in exposed~     individuals. The majority of the population is seropositive for this virus. Reactivation of~     varicella zoster virus occurs in up to 30% of the general population over 60 years old.~      Solid organ transplant recipients receive lifelong immunosuppression drugs and are at great~     risk of reactivation of all herpesviruses including the varicella zoster virus regardless of~     age. The vaccine has been shown to be effective in preventing shingles in the general~     population. The investigators' purpose is to determine how well the vaccine works in patients~     on renal replacement therapy and post-transplant.~   "
200301|NCT00940927|"~     The purpose of this study was to determine the lung function response after increasing doses~     of albuterol (a bronchodilator) in children and adults with asthma.~   "
200302|NCT00940914|"~     About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson~     disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess~     the relationship between the loss of dopaminergic neurons and the existence of pain in~     Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging~     (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain~     threshold, the investigators will establish correlations between dopaminergic degeneration~     and pain perception.~   "
200303|NCT00940901|"~     This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor~     sildenafil has an effect on the frequency of recurrent priapism and the quality of life of~     males with sickle cell disease (SCD).~   "
200304|NCT00940888|"~     The purpose of this study is to characterize the chronic performance of the St. Jude Medical~     SJ4 connector and RV high voltage SJ4 leads.~   "
200305|NCT00940875|"~     This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva~     and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients,~     or patients with ECOG performance status of 2, with advanced non-small cell lung~     cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on~     days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine~     monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on~     study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
200306|NCT00940862|"~     This study is to determine the effect of adalimumab on inflammation of blood vessels that~     could lead to heart attack in patients with psoriasis. Changes to the carotid artery and~     ascending aorta will be evaluated in patients treated with adalimumab (systemic treatment)~     and compared against patients treated with a topical treatment that does not affect the~     entire body.~   "
200307|NCT00940849|"~     Background of the study:~      Plant sterols can play an important role in lowering plasma cholesterol. The extent to which~     plant sterols can reduce plasma cholesterol levels depends on the intake scenario. We suggest~     that the difference in these effects depends on gastric emptying and bile secretion.~      Objective of the study:~      The aim of this study is to gain insight in the mechanisms that may be involved in the~     effects of plant sterol drinks on gastric emptying and gallbladder motility. In order to test~     this, we compare the different effects of the consumption of a plant sterol containing drink~     prior to, during and after a standardized meal.~   "
200308|NCT00940836|"~     The aim of this study is to assess the efficacy and safety of an anti-cold preparation~     compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and~     flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled~     clinical trial.~   "
200309|NCT00940823|"~     The purpose of this study is to compare the safety and efficacy of the Ahmed valve and the~     Baerveldt implant in treating refractory glaucoma. Eligible patients will be recruited from~     multiple study centers and randomized to a glaucoma drainage device for implantation. They~     will be followed long-term based upon outcome measures including intraocular pressure,~     glaucoma medication use, visual acuity, complications of the surgery and further treatments~     required.~   "
200310|NCT00940810|"~     The purpose of this study is to compare the plasma disc decompression (PDD) procedure to~     conservative care (physiotherapy) for the treatment of patients with radicular pain~     originating from a disc protrusion. Treatment efficacy and rate of improvement is evaluated~     at 8 weeks after treatment start and followed-up for 1 year after treatment start.~   "
200311|NCT00940797|"~     The aim of this study is to determine the effect of DMMET-01 on insulin sensitivity by~     Glucose CLAMP technique in Mexican type 2 diabetes patients, after 2 months of treatment.~   "
200312|NCT00940784|"~     Clopidogrel (Plavix) and aspirin are two antithrombotic agents (blood thinners) commonly used~     in patients with previous thrombotic events (stroke or heart attack). Thrombosis is the~     formation of a blood clot in a blood vessel. Patients with polycythemia vera are routinely~     treated with aspirin which has been shown to be effective in reducing their thrombotic risk.~     However, in polycythemia vera patients with previous thrombosis, a further benefit might be~     obtained by using the combination of aspirin and clopidogrel which is routinely used in~     patients with recent acute myocardial ischemia (reduced blood supply to the heart muscle).~     The study will assess whether this combination therapy greatly increases the risk of bleeding~     versus aspirin alone, if clopidogrel reduces biological factors that might lead to a stroke~     or heart attack, and whether a high number of patients with polycythemia vera are resistant~     to clopidogrel.~      Approximately 200 subjects will be enrolled to the Myeloproliferative Disorders-Research~     Consortium (MPD-RC) study in Europe and the United States with participation expected to last~     for 7 months (6 months of receiving study medication plus a 30 day follow-up visit).~   "
200345|NCT00940355|"~     The purpose of this study is to determine the effectiveness of an intervention conducted by a~     pulmonary nurse in patients with COPD.~      The hypothesis is that in a sample of COPD patients with clinically relevant problems in~     health status (physiological functioning, symptoms, functional impairment and quality of~     life), a motivational intervention conducted by a pulmonary nurse will lead to~     patient-tailored treatment and an improved health status.~   "
200346|NCT00940342|"~     The goal of this clinical research study is to learn if giving granulocyte-macrophage~     colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of~     rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of~     this combination treatment will also be studied.~   "
238160|NCT00438087|"~     Facial palsy after surgical removal of cranial base tumors adherent to the nerve can partly~     be explained by inflammation.~   "
200313|NCT00940771|"~     The hypothesis for this study is will a treatment regimen containing Atazanavir in~     combination with Ritonavir work as well as other regimens containing a protease inhibitor~     (PI, one of 5 classes of HIV Medications) and/or a Non-nucleoside Reverse Transcriptase~     Inhibitor (NNRTI, another of the classes of HIV medications) at controlling HIV disease in~     children who are HIV+ and have high cholesterol or high triglycerides. . In this study,~     children who have high cholesterol or high triglycerides as a result of their HIV medicines,~     will have the PI or NNRTI in their medication regimen changed to Atazanavir, which is a PI in~     combination with a low dose of Ritonavir (another PI). Atazanavir has been shown in adults to~     result in lower cholesterol and triglycerides than other PI's and NNRTI's. The dose of~     atazanavir and ritonavir will be according to the Package Insert for this drug that is FDA~     approved for children. They will continue taking the other medications from the pre-study~     regimen. Children will take study drug for 24 weeks, and will be able to continue study drug~     after the study using commercially available drug. Lab tests and a physical exam will be~     undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine how~     effective the new drug is and to monitor for possible side effects.~   "
200314|NCT00940758|"~     The purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile,~     maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02~     treatment.~   "
200315|NCT00940745|"~     The purpose of this study is to evaluate the superiority of effect of the modified~     micro-invasive aspiration and drainage and conservative medical therapy in the treatment of~     ICH spontaneously hypertensive scientifically.~   "
200316|NCT00940732|"~     The purpose of this study is to determine whether positive mental health help-seeking~     attitudes, and behaviour in elite athletes can be increased through an online intervention.~   "
200317|NCT00940719|"~     In patients with Relapsing Remitting Multiple Sclerosis (RRMS), the investigators observed a~     positive correlation between regulatory T cell (Treg) function and vitamin D status. The~     present goal is to assess whether Treg function improves on supplementation with vitamin D3.~   "
200318|NCT00940706|"~     There is increasing evidence that physical activity during childhood and adolescence has an~     important impact on health and behavior outcomes. Lack of physical activity is currently a~     major concern for the total population and especially for children and adolescents. People~     with disabilities are at risk for the same health problems as the general population. Due to~     their disabilities, they have a higher risk for developing secondary conditions that may~     further affect their health and quality of life.The goals of this project are to develop and~     evaluate new approaches of treatment for children with cerebral palsy (CP) and to develop low~     cost tests for evaluating motor functions in natural environments.~      The overall aim is to raise awareness of, and promote, a physically active lifestyle for~     Middle East teenagers with disabilities due to CP by means of a collaborative~     Jordanian-Israeli-Palestinian-Moroccan applied research project. Specific objectives include:~        1. Evaluation of baseline levels of physical activity in large populations of children and~          teenagers with CP in the communities of the participating countries by long-term~          monitoring by accelerometers.~        2. Conducting a randomized clinical trial to compare the efficacy of an experimental~          physical training program with a treadmill training program in two groups. The~          experimental training program is based on results of recent motor control studies, as~          well as the motor learning approach to facilitate transfer and retention of learned~          walking activities.~        3. Disability Advocacy through dissemination of activity focus programs, raising awareness,~          making use of new technologies and enhancing and developing the skills and training of~          personnel working with populations with CP.~        4. Continuing the expansion of collaborative research efforts pertaining to children and~          teenagers with physical disabilities between Arab countries and Israel through sharing~          of skills and knowledge by exchange visits, meetings and seminars and joint training,~          pediatric physiotherapists and physical educators.~   "
200319|NCT00940693|"~     The purpose of this study is to determine whether duloxetine is an effective treatment of~     attention deficit disorder in adults.~   "
200320|NCT00940680|"~     The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan~     and losartan alone in patients with essential hypertension inadequately controlled on~     losartan monotherapy.~   "
200321|NCT00940667|"~     The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan~     and amlodipine alone in patients with essential hypertension inadequately controlled on~     amlodipine monotherapy.~   "
200322|NCT00940654|"~     The purpose of this multination multicenter observational study is to determine the impact of~     fever and antipyretic on outcomes in critically ill patients.~   "
200323|NCT00940641|"~     The purpose of this study is to evaluate the absorption, distribution, metabolism and~     excretion of AZD7325 after intravenous and 14C labeled oral dose~   "
200324|NCT00940628|"~     This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or~     overweight adolescents. Patients will be randomised into one of 2 groups; both groups will~     undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also~     receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the~     target sample size is <100 individuals.~   "
200325|NCT00940615|"~     The current project will examine the effects of aerobic exercise on cognition among a group~     of veterans who have suffered a mild traumatic brain injury.~   "
200326|NCT00940602|"~     The primary purpose of this study is to prospectively assess the efficacy and safety of iron~     chelation therapy with deferasirox compared to placebo in patients with myelodysplastic~     syndromes (low/int-1 risk) and transfusional iron overload.~   "
200327|NCT00940589|"~     The aim of this exploratory randomized, placebo controlled study is to evaluate the efficacy~     of Circadin® 2mg in patients with mild to moderate Alzheimer Disease (AD) treated with the~     acetylcholinesterase (AChE) inhibitor. The effects of add-on Circadin® 2mg vs. placebo on the~     decline in cognitive skills and global functioning, as well as on daytime somnolence and will~     be assessed.~   "
200328|NCT00940576|"~     Mare's milk consumption could improve the well-being in patients with Crohn's disease and~     ulcerative colitis, respectively.~   "
200329|NCT00940563|"~     Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced~     gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding~     its best clinical use in terms of tumor response, survival, tolerability and safety profile~     will be prospectively collected.~   "
200381|NCT00939887|"~     This is a subject blind, investigator and sponsor open, randomized study consisting of 2~     parts. Up to 15 healthy subjects will be included in the study. In the first part of the~     study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will be~     assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid receptor~     occupancy (RO) will be assessed in up to three cohorts of subjects.~   "
242889|NCT00375180|"~     The investigators hope to learn more about how side-effects of RT or RTchemo affect food~     intake and nutrition status.~   "
200330|NCT00940550|"~     This study has been designed to compare the effects of melatonin with those of drugs~     (temazepam and zolpidem) regularly prescribed for the treatment of insomnia, in healthy,~     middle-aged volunteers.~      The study will take place at one centre. Volunteers consenting to participate in the study~     will have their eligibility confirmed by a screening panel, including spending one night in~     the sleep clinic to acclimatize to the study procedures. Blood and urine samples will be~     collected during this overnight visit.~      Volunteers continuing to remain eligible will receive, in turn, melatonin, temazepam,~     zolpidem and placebo as a single dose during 4 treatment phases lasting one night and~     separated by at least five days. Neither the volunteer nor the study staff will be aware of~     which drug each volunteer is receiving at each treatment phase.~      The volunteer's electrical brain activity will be measured whilst sleeping. Other aspects of~     sleep, including measures of sleep quality, will also be measured. Urine samples will be~     collected during each treatment phase.~      Volunteers will undergo an assessment of health prior to departure from the clinic at their~     last treatment phase, and study staff will telephone 2 weeks later to obtain further~     information on their health status.~      The primary study objective is to compare EEG power spectra during nonREM sleep in the~     slow-wave frequencies following administration with melatonin to temazepam.~   "
200331|NCT00940537|"~     The purpose of this study is to see how effective the investigators' optimized magnetic~     resonance spectroscopy (MRS) sequence in quantifying hepatic triglyceride content (HTGC) to~     enhance MRS as a diagnostic tool in non-alcohol fatty liver disease (NAFLD).~   "
200332|NCT00940524|"~     This research study is for people with a specific type of leukemia called Philadelphia~     chromosome positive acute lymphoblastic leukemia (the type the patients have). The~     investigators plan to give you combination of 3 drugs (dasatinib, mitoxantrone, cytarabine)~     for the first part of the chemotherapy (called Induction). The investigators have previously~     shown that the combination of mitoxantrone and cytarabine is very effective in your kind of~     leukemia. The purpose of this study is to establish a safe dose range of dasatinib in~     combination with this standard induction chemotherapy based on side effects. If possible, the~     trial will also give us an idea of how well this combination might work in treating your~     leukemia. Previous studies have shown that dasatinib can produce responses when given alone~     for your kind of leukemia. By using the dasatinib together with the chemotherapy, the~     investigators believe that we can kill even more leukemia cells than with either treatment~     alone. The investigators will initially treat patients with a low dose of dasatinib and~     monitor for side-effects. If the initial group of patients is able to tolerate this low-dose~     of dasatinib, then future patients will receive higher doses of dasatinib. Mitoxantrone and~     cytarabine chemotherapy is the standard therapy at the investigators' institution for the~     patient's leukemia and it is the combination of dasatinib with this chemotherapy that is new~     and investigational in this study.~   "
200333|NCT00940511|"~     The purpose of this study is to improve the quality of care for individuals with multiple~     chronic conditions, health care systems have begun turning to coordinated care. Although~     coordinated care can refer to many different things, it usually includes activities such as~     assessing patients' needs, referring them to the right doctors, helping them make and keep~     appointments, and helping them comply with medical or dietary recommendations. To understand~     the effects of coordinated care for high-needs Medicaid recipients, MDRC is conducting a~     randomized trial of a pilot coordinated care program run by Kaiser Permanente for blind and~     disabled Medicaid recipients in the Denver area.~   "
200334|NCT00940498|"~     This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The~     purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a~     Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In~     Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and~     preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer,~     ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of~     brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who~     consent to provide tumor biopsies while participating in the study.~   "
200335|NCT00940485|"~     This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential~     treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who~     have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to~     one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po~     daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study~     treatment is 3-12 months.~   "
200336|NCT00940472|"~     The aim of this clinical trial is to compare the efficacy of DMMET-01 versus metformin~     hydrocloride on metabolic control in mexican type 2 diabetes patients without prior~     pharmacological treatment.~   "
200337|NCT00940459|"~     The purpose of this study was to evaluate the effect of different contact lens edge designs~     on the circumlimbal conjunctiva.~   "
200338|NCT00940446|"~     The purpose of this study is to compare the use of INSORB absorbable staples with metal~     staples on surgical incision healing after total hip replacement. The study evaluates wound~     healing, complications, and patient satisfaction regarding wound comfort and appearance after~     surgery.~   "
200339|NCT00940433|"~     This study compares the outcome of the four most commonly used operations for the repair of~     primary groin hernia including the new key hole surgical techniques. It aims at answering the~     question of whether the new technology really improve the outcome, saves time and reduce~     patient suffering.~   "
200340|NCT00940420|"~     This 2 arm open-label study will assess the safety and tolerability of combination treatment~     with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis~     C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week~     and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the~     treatment arms is to the discretion of the investigator (mainly according to genotype).~     Adverse events will be monitored throughout the study and hematologic parameters every 2~     weeks and twice during the 24-week follow-up.~   "
200341|NCT00940407|"~     The purpose of this study is to evaluate clinical outcomes of Photobiomodulation treatment on~     patients with dry Age Related Macular Degeneration (AMD).~      Photobiomodulation is the use of non thermal, non laser light of specific wavelengths and~     energy directly on the eye to improve retinal function and delay AMD progression.~      This is a prospective 2 center phase 2 clinical pilot study with no placebo group.~   "
200347|NCT00940329|"~     This Phase I, open, randomized controlled, multiple-dose, parallel-group study investigated~     the potential pharmacodynamic and pharmacokinetic interactions between multiple doses of oral~     roflumilast and inhaled formoterol. Healthy male subjects were assigned to treatment A or~     treatment B. Subjects in treatment A received 500 μg/d roflumilast from day 2 to day 18 and~     48 μg/d formoterol from day 12 to day 18. Subjects in treatment B received 48 μg/d formoterol~     from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18. Impedance cardiography,~     ECG, serum potassium and glucose concentrations and effects on blood eosinophils assessed~     potential pharmacodynamic interactions. In addition, the safety and tolerability were~     evaluated. Pharmacokinetic parameters were assessed for roflumilast, roflumilast N-oxide, and~     formoterol.~   "
200348|NCT00940316|"~     RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab~     may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used~     in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet~     known whether erlotinib hydrochloride given together with panitumumab is more effective with~     or without irinotecan in treating patients with metastatic colorectal cancer.~      PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together~     with panitumumab to see how well it works with or without irinotecan hydrochloride as~     second-line therapy in treating patients with metastatic colorectal cancer.~   "
200349|NCT00940303|"~     This single arm study will assess progression-free survival, feasibility of use and safety of~     Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line~     treatment in patients with metastatic colorectal cancer. Patients will receive up to 12~     bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant~     chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The~     anticipated time on study treatment is until disease progression, and the target sample size~     is <100 individuals.~   "
200350|NCT00940290|"~     Clinical practice guidelines (CPG) are systematically developed statements to assist~     practitioner and patient decisions about appropriate health care for specific clinical~     circumstances. They are developed to give a recommendation based on the best evidence~     available. Through a randomized trial, the investigators intend to provide information about~     which of the four grading systems most used today to grade evidence and recommendations in~     CPGs, could change physician´s behavior towards a common clinical situation in daily~     practice.~   "
200351|NCT00940277|"~     The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions~     developed to reduce the psychological distress on women and their partners during and after~     the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG),~     incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills)~     as well as basic relationship communication and support skills (e.g., expressing support~     needs constructively). The second group, a Couples' Support Group (SG), is a non-structured~     group where general topics are discussed. The investigators will evaluate the impact of each~     group condition on patients' psychological adaptation, social and role functioning, and~     cancer treatment adherence. The investigators will also evaluate whether patient and partner~     perceptions of relationship support, relationship intimacy, stress management skills, and~     intervention group support mediate the groups' effects on each other's psychological~     adaptation.~      The investigators hypothesize that ECG will have stronger positive effects on patient general~     and cancer-related distress and well-being than SG.~      The investigators hypothesize that group support will mediate greater improvements in patient~     psychological functioning in both groups but that the effects of group support will be~     significantly stronger in SG than ECG.~   "
200352|NCT00940264|"~     Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of~     interest as an available NOTES-Procedure for the clinical routine. Few authors have~     demonstrated the feasibility and safety in a selected patient collective. The aim of this~     prospective data collection is to evaluate the feasibility in the clinical routine in a non~     select patient collective.~      Therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy~     will be included and assessed concerning feasibility to perform the transvaginal approach and~     complete the operation transvaginally.~   "
200353|NCT00940251|"~     To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic~     patients with secondary failure to oral hypoglycemic agents, a randomized double blind,~     single centre, study of 3 months duration was carried out.~   "
200354|NCT00940238|"~     -  Objective:~             -  To compare the rate and extent of absorption of Citalopram Hydrobromide Tablets 40~               mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured by Torrent~               Pharmaceuticals Limited, India Reference Product: CelexaTM Tablets 40 mg (Reference~               Listed Drug) manufactured by Forest Pharmaceuticals Inc., Missouri under fasting~               conditions in 36 healthy, adult, human subjects in a randomized crossover study.~        -  Study Design:~             -  Open-label, randomized, two period crossover studies in 36(Fasting)healthy, normal~               subjects to compare the single dose bioavailability of Torrent's Citalopram~               Hydrobromide tablets 40 mg and Forest Pharmaceutical's Celexa 40mg tablets.~   "
200355|NCT00940225|"~     The purpose of this study is to determine whether or not XL184 demonstrates anti-tumor~     activity in selected tumor types under a randomized discontinuation trial (RDT) design.~     Subjects who have responded to study drug after 12 weeks of open-label XL184 administration~     will continue to take XL184. Subjects who are clearly progressing will discontinue study~     treatment and subjects who demonstrate stable disease will be randomized to either XL184 or~     placebo. For individual patients, once disease progression is observed, the blind will be~     broken and subjects who were randomized to placebo will be offered the option to receive~     open-label XL184. Subjects who progressed while taking XL184 will discontinue study~     treatment.~      Emerging data may support enrollment in an open-label, non-randomized expansion cohort (NRE).~     There will be NRE cohorts for prostate and ovarian cancers.~   "
200356|NCT00940212|"~     The primary aim of this study is to investigate the safety and tolerability of AZD2423 single~     doses in healthy volunteers.~   "
200357|NCT00940199|"~     Patients with breast cancer scheduled to undergo sentinel lymph node mapping and biopsy will~     be randomly assigned to one of four treatment groups:~      I: (Standard of Care at WRAMC): Application of L-M-X topical anesthetic cream 4% to the~     breast within one hour of sub-areaolar injection of 4 ml 99mTc-sulfur colloid (1 mCi in~     normal saline)~      II. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium~     bicarbonate)~      III. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in 1% Lidocaine)~      IV. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium~     bicarbonate + 1% Lidocaine)~      The primary study outcome is pain, which will be evaluated for each study group before, and~     after radiocolloid injection utilizing a standardized 10-point Likert scale, the Wong-Baker~     FACES Pain Rating Scale, and the McGill Pain Questionnaire. Physician appraisal of patient~     pain (Wong-Baker FACES Pain Rating Scale) will be estimated during the radiocolloid injection~     and compared with that of the patient.~   "
200358|NCT00940186|"~     Study on the phamacokinetics of Pikamilone in healthy Chinese subject and provide~     informations for further phase II study.~   "
200359|NCT00940173|"~     The purpose of this study is to establish the safety of xenotransplantation of~     DIABECELL(R)[immunoprotected (alginate-encapsulated) porcine islets] in patients with~     established type 1 diabetes mellitus, and to establish preliminary evidence of the efficacy~     of DIABECELL(R), as measured by a reduction in serial hemoglobin A1c (HbA1C) levels.~   "
200360|NCT00940160|"~     This study is designed to investigate the safety and tolerability of multiple doses of QAX576~     in controlled or partially controlled asthma patients.~   "
200361|NCT00940147|"~     Airway complications are a significant cause of morbidity after lung transplantation (LTx).~     Bronchoscopic evaluation may help to identify risk factors for requiring interventions later.~   "
200362|NCT00940134|"~     The purpose of this study is to investigate the effects of intravenous infusion of two~     gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in~     healthy obese men. The investigators hypothesize that an intravenous infusion of each hormone~     alone will decrease food intake at a buffet meal and decrease appetite, and that in~     combination, there will be a greater decrease in food intake and appetite compared to each~     hormone alone.~   "
200363|NCT00940121|"~     The purpose of this study is to assess the pharmacokinetics of three doses of oral mirabegron~     formulations with three different release rates versus three doses of mirabegron administered~     intravenously; to study safety and side effects of the oral and IV doses of mirabegron.~   "
200364|NCT00940108|"~     The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for~     eliciting an immune response to H1N1 influenza in healthy children.~   "
200365|NCT00940095|"~     The aim of this study is to demonstrate that clazosentan, administered as a continuous~     intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid~     hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and~     all-cause mortality within 6 weeks post-aSAH treated by endovascular coiling.~      The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity,~     and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the~     following:~        1. Death (all causes).~        2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant~          contributing cause, or not adjudicated to be entirely due to causes other than~          vasospasm.~        3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the~          primary or relevant contributing cause, or not adjudicated to be entirely due to causes~          other than vasospasm.~        4. Administration of a valid rescue therapy in the presence of confirmed cerebral vasospasm~          on angiography (DSA or CTA).~      An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet~     the primary endpoint and its individual morbidity components.~   "
200366|NCT00940082|"~     Objectives: To investigate the cardiac condition of the diabetic patients in our hospital in~     order to seek for the new diagnostic method of warning its cardiovascular complications in~     early times.~      Methods: 317 diabetic patients in our hospital from January in 2004 to July in 2008 were~     divided into 2 groups: group A (106 patients whose age ranged from (31-59) and group B (211~     patients whose age ranged from (60-90). The height, weight, blood glucose, glycosylated~     hemoglobin, lipid, blood pressure, course of disease, ejection fraction (EF), fractional~     shortening(FS), diameter of left ventricle in late diastolic stage(LVEDd), the thickness of~     the ventricular septa（IVSDand the posterior wall of the right ventricle in late diastolic~     stage (LVPWd)were recorded respectively. Left ventricular mass index (LVMI), relative wall~     thickness (RWT) were calculated and High-sensitive C-reactive protein (HsCRP), homocysteine~     and TNF-α were detected. Multifactor logistic regression was made based on the comparison and~     contrast between all indexes to analyze the correlations between age and the positive~     indexes.~   "
200367|NCT00940069|"~     The investigators performed a multicenter, open trial of using TS gene polymorphism to~     predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as~     first-line treatment.~   "
200368|NCT00940056|"~     Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to~     rate control management of AF.~      Secondary Objectives~      Does totally endoscopic ablation:~        -  reduce atrial fibrillation symptoms?~        -  increase working capacity and improve quality of life?~        -  improve atrial function?~        -  reduce the risk for stroke?~   "
200382|NCT00939874|"~     The purpose of this study is to determine if low bone mineral density (a measurement of how~     thick and strong bones are) improves in adults with HIV infection who switch their HIV~     medication tenofovir to another HIV medication raltegravir.~      Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic~     patients switching from ART including tenofovir disoproxil fumarate (TDF) and a~     ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.~   "
200383|NCT00939861|"~     Study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection~     for endometriosis on digestive, gynaecologic, general symptoms and quality of life. Morbidity~     and fertility outcomes will also be evaluated.Primary purpose of the protocol is the~     evaluation of dyschesia.~   "
200508|NCT00938223|"~     This is an open-label, phase II study of a vaccine comprising melanoma peptides and a tetanus~     helper peptide, administered in GM-CSF-in-adjuvant. Patients will be randomized to receive~     one of two different vaccine regimens. Patients will be stratified by stage of disease (IIB~     versus III versus IV).~   "
200369|NCT00940043|"~     Prematurity represents 8% of birth and it is one of the leading causes of infant~     complications. The preterm premature rupture of membranes (PPROM) represents one-third of~     preterm birth and the rupture of membranes increase the risk of fetal exposition to infection~     which could lead to neurological sequels. Classic management of women with PPROM before 32SA~     is based on the extension of the pregnancy with the risk of adding complications like a~     secondary infection. Moreover, different studies have shown that fetal infection could be one~     of the most important risk factor for subsequent neurological complications. However, it is~     difficult to know if it is better to extend the pregnancy to gain in maturity or to arrest~     the pregnancy to avoid the risk of intrauterine infection. The research objective is to~     suggest a new strategy to manage women with PPROM. With this new strategy, the investigators~     seek to extend pregnancy as much as possible but the investigators would like to give birth~     before the intrauterine infection. The investigators suggest detecting protein associate with~     neurological complications of preterm child in the amniotic liquid found in the vagina of the~     mother. A positive test will lead to the delivery of the newborn before its infection. The~     hypothesis is that it is possible to study changes in the inflammatory status of patients who~     presented an PPROM from repeated detection of interleukins in vaginal secretions.~   "
200370|NCT00940030|"~     The purpose of this study is to evaluate mechanical bowel preparation (MBP) with polyethylene~     glycol plus bowel enema versus bowel enema alone in patients candidates to colorectal~     resection for malignancy.~   "
200371|NCT00940017|"~     The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to~     determine the drug concentration in the lung.~   "
200372|NCT00940004|"~     Objectives:~      This is an exploratory study, consisting of two parts. In part I a dose escalation is~     performed and the primary objective is the safety of different doses of TLR-dendritic cell~     (TLR-DC). In part II TLR-DC vaccination will be compared with cytokine-matured DC vaccination~     and the primary objective of this part is the immunological response to TLR-DC vaccination,~     with toxicity and clinical efficacy being secondary objectives. These studies will provide~     important data on the safety and immunological effects of TLR-matured DC.~      Study design:~      This study is an open label prospective exploratory intervention study.~      Study population:~      The investigators' study population consists of HLA-A2.1 positive melanoma patients, with~     proven expression of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma~     patients with regional lymph node metastasis in whom a radical lymph node dissection is~     planned or performed within 2 months of inclusion in this study (further referred to as stage~     III) and melanoma patients with measurable distant metastases (further referred to as stage~     IV) will be included.~   "
200373|NCT00939991|"~     This is a Phase I/II open-label, single-arm study among recurrent malignant glioma patients.~     Patients will be treated with Vorinostat in combination with Bevacizumab (BV) (10 mg/kg) and~     Temozolomide (T) (50 mg/m2/day) BV is administered every 2 weeks. Temozolomide will be taken~     orally once every day. Vorinostat will be taken orally on days 1-7 and 15-21 of each 28-day~     cycle. In the phase I portion of this study, the dose of Vorinostat will be escalated in~     successive cohorts of patients to determine the maximum tolerated dose (MTD) based on~     dose-limiting toxicities (DLTs). In the phase II portion of this study, the dose of~     Vorinostat will be the MTD determined in the phase I portion. The primary endpoint of the~     phase II study is 6-month progression-free survival (PFS) for recurrent GBM (Glioblastoma)~     patients. This study will be conducted at The Preston Robert Tisch Brain Tumor Center at~     Duke.~   "
200374|NCT00939978|"~     The administration of rhEPO on the one day before cardiac surgery will be effective to~     decrease the bleeding due to the surgery.~   "
200375|NCT00939965|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors plan better treatment for patients receiving isotretinoin.~      PURPOSE: This clinical trial is studying the side effects and best dose of isotretinoin in~     treating young patients with high-risk neuroblastoma.~   "
200376|NCT00939952|"~     The objective of this study is to characterize the pharmacokinetic profile of ertapenem~     during continuous ambulatory peritoneal dialysis (CAPD).~   "
200377|NCT00939939|"~     The goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein~     metabolism in type 2 diabetic patients.~   "
200378|NCT00939926|"~     Objective:~        -  To assess the bioequivalence of Risperidone 1.0 mg tablets of Torrent Pharmaceuticals~          Limited., India and Risperdal® (Risperidone) 1.0 mg tablets of Janssen Pharmaceutical~          Products, LP, USA, in healthy human adult subjects, under fed conditions.~      Study Design:~        -  A randomized, open label, two treatment, two period, two sequence, single dose,~          crossover study, under fed conditions.~   "
200379|NCT00939913|"~     In patients undergoing coronary angiography, the incidence of contrast induced~     nephropathy(CIN)varies widely and ranges from < 5% in the lowest risk patients, to nearly 50%~     in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be~     effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the~     bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence~     of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic~     administration of intravenous NAC.~      This is a prospective, randomized, double-blind, placebo-controlled single center clinical~     trial designed to evaluate the effects of intravenous NAC on patients with acute coronary~     syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention~     (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc~     (www.cumberlandpharma.com).~      Patients will be excluded if they have end-stage renal disease requiring dialysis,known~     hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point~     is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration~     of hospitalization and change in serum cystatin C level.~   "
200380|NCT00939900|"~     The purpose of this study is to test the effect of zoledronic acid over 2 years in preventing~     early collapse and progression of joint dome depression (≥ 2 mm by X-ray) of the femoral head~     in patients with large (> 30%: criteria according to Kim et al) nontraumatic osteonecrosis.~   "
200418|NCT00939406|"~     The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients~     undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk~     herniation. The device is used as an adjunct in lumbar spine surgery to prevent post-~     surgical fibrosis and adhesions, and improve patient outcomes.~   "
200384|NCT00939848|"~     As a result of our previous NCRN study (ABC-02) cisplatin and gemcitabine (CisGem) is likely~     to become the international standard of care for patients with advanced biliary tract cancer~     (submitted: ASCO 2009).~      This study, ABC-03, will determine whether the addition of cediranib(an oral Vascular~     Endothelial Growth Factor Receptor inhibitor) to CisGem will improve the time to disease~     progression in this patient group.~   "
200385|NCT00939835|"~     -  Objective:~             -  The objective of this study is to compare the rate and extent of absorption of the~               Test Product, Citalopram Hydrobromide 40 mg (Torrent Pharmaceutical Limited) to the~               Reference Product, RLD Tablets 40 mg (Forest Pharmaceuticals Inc, Missouri) under~               fed condition~        -  Study Design:~             -  Randomized, Single Dose, Open Label, Non-Replicate, Two-period, Two-treatment, Two-~               Sequence Crossover Bioequivalence Study comparing Citalopram Hydrobromide Tablets~               40 mg (manufactured by Torrent Pharmaceuticals Ltd). With RLD Tablets 40 mg~               (manufactured by Forest Pharmaceuticals Inc Missouri) in 24+2 normal healthy male~               subjects with a wash out period of 15 days between the two study periods, in fed~               condition.~   "
200386|NCT00939822|"~     The purpose of the research is to see how simvastatin affects a substance in the body called~     beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and~     spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting~     Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid~     in the spinal fluid. This study will also see if simvastatin affects memory and thinking,~     blood flow in the brain, and blood vessel function. The investigators hope that future~     studies show whether simvastatin might prevent memory loss and decrease the chance of~     developing Alzheimer's disease.~   "
200387|NCT00939809|"~     This phase II trial is studying the side effects and how well A6 works in treating patients~     with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary~     peritoneal cancer. A6 may stop the growth of tumor cells by blocking blood flow to the tumor.~   "
200388|NCT00939796|"~     The objective of this investigational study is to evaluate the safety and performance of the~     Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube~     [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME)~     or recurrent acute otitis media (AOM).~   "
200389|NCT00939783|"~     The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in~     patients with Alzheimer's disease.~   "
200390|NCT00939770|"~     RATIONALE: Crizotinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of crizotinib and~     to see how well it works in treating young patients with relapsed or refractory solid tumors~     or anaplastic large cell lymphoma.~   "
200391|NCT00939757|"~     The purpose of this study is to assess the effect of food on the pharmacokinetics of a single~     oral dose of mirabegron in healthy male and female subjects.~   "
200392|NCT00939744|"~     Recent studies show that EET and 20-HETE have important biological effects, particularly in~     the vascular system. The investigators studied the effect of eicosanoids on the gravid rat~     uterus. The results suggest that 20-HETE had an tocolytics effect on gravid uterus. In the~     previous study, we demonstrated that the enzymes of the pathway of EET were present in human~     uterine tissues. Moreover, the addition of an inhibitor of degradation of EET had an~     tocolytic effect on the human myometrium, as the exogenous addition of 8.9, 14,15-EET and~     20-HETE.~      Objectives:~      Primary objective: To compare the balance of different metabolic pathways of arachidonic acid~     (AA) of the pregnant human myometrium in pathological situations (preterm labor, uterine~     atony, prolonged pregnancy).~      Specific objectives: i) To study the effect of derived from the AA on in vitro contractile~     activity of normal and pathological uterine tissues, and ii) detect and quantify the~     different sub-products of metabolism of AA in the uterine tissues (myometrium, fetal~     membranes and placenta).~      The management of uterine contraction is in the heart of modern obstetrics year, yet the~     progress made in other specialties, based on the study of smooth muscle have not yet been~     transposed in obstetrics. A better understanding of systems for regulating the contraction is~     important in terms of 1) new physiological knowledge, but it could also be the source of 2)~     modification of strategies to take care of premature delivery (new Tocolytic), or 3)~     improving the efficiency of uterine muscle during delivery or 4) for treatment of patients~     with prolonged pregnancy.~   "
200393|NCT00939731|"~     The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over,~     single-dose study employing administration of two PF-02341066 formulations in the fasted~     state to healthy adult volunteers.~   "
200394|NCT00939718|"~     While treating depression, significant numbers respond poorly to anti-depressants; one cause~     is vitamin B12 deficiency. The investigators are conducting an open label randomized~     controlled trial to investigate difference in response to SSRI monotherapy alone versus SSRI~     and intramuscular B12 replacement in people with low-normal B12 levels. 300 participants will~     be allocated to each arm of intervention at out patient clinics of the department of~     Psychiatry at Aga Khan University Hospital, Karachi Pakistan. Baseline and 3 month~     measurement of depression will be on Hamilton Rating Scale for Depression (Urdu version) and~     response rates compared.~   "
200395|NCT00939705|"~     -  Objective:~             -  Compare the bioequivalence of a test topiramate formulation (Torrent~               Pharmaceuticals Limited) to an equivalent oral dose of the commercially available~               topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of adult~               subjects under fed conditions.~        -  Clinical Design:~             -  Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human~               adult subjects.~   "
200396|NCT00939692|"~     -  Objective:~             -  Compare the bioequivalence of a test topiramate formulation (Torrent~               Pharmaceuticals Limited) to an equivalent oral dose of the commercially available~               topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26~               adult subjects under fasted conditions.~        -  Clinical Design:~             -  Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human~               adult subjects.~   "
200974|NCT00932074|"~     The purpose of this study is to assess the safety, tolerability and efficacy of KP‑413~     topical ointment compared with vehicle ointment in treating adult subjects with atopic~     dermatitis (AD).~   "
200397|NCT00939679|"~     The purpose of this study is to investigate the short term and long term effects of Roux-en-Y~     gastric bypass (RYGB) surgery on energy expenditure, gastrointestinal and appetite regulating~     hormone levels, and appetite sensation. We hypothesize that following RYGB surgery,~     metabolism will be elevated in comparison to patients who have not yet had RYGB but who are~     losing weight simultaneously using a low calorie diet. We further hypothesize that this~     higher metabolism will be associated with alterations in fasting and postmeal levels of~     gastrointestinal and appetite regulating hormones. Long term (1.5 years after RYGB), we~     hypothesize that differences in metabolism, body composition, and hormone levels will~     distinguish between patients who have maintained their weight loss after RYGB vs those who~     have regained weight.~   "
200398|NCT00939666|"~     The high proportion of complete and good responders with modern chemoradiation and the~     improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest~     to the question whether in patients with complete or good response the overall benefits of a~     'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive~     follow-up may outweigh the benefits associated with conventional surgery (total mesorectal~     excision (TME)or abdominoperineal resection (APR)). On the one hand, less invasive strategies~     will expose subjects to more diagnostic procedures and possibly a slightly higher risk of~     local failure and the need for salvage surgery. On the other hand, mortality and morbidity~     associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic~     infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary~     incontinence and sexual dysfunction) can be avoided. The investigators believe that~     wait-and-see policy for complete responders and TEM for good responders after chemoradiation~     is a feasible alternative to standard surgery, provided these patients are intensively~     followed.~   "
200399|NCT00939653|"~     Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating~     children (age 1-21) with leukemia. This research study will use clofarabine with two other~     cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and~     cyclophosphamide (Cytoxan®).~      Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study to~     find out the highest doses of these drugs that can be safely given to children with relapsed~     or refractory leukemia. This study is a phase II study which will use the drugs to study how~     well these drugs work against AML. This study will also examine the safety of this drug~     combination.~   "
200400|NCT00939640|"~     Heart failure with preserved systolic function (HF-PSF, or 'diastolic heart failure')~     accounts for half of hospitalizations for heart failure in patients over the age of 65. Most~     HF-PSF patients have systemic hypertension (HTN), and characteristic HTN-induced~     cardiovascular changes contribute to HF-PSF. However, it is unclear why most patients with~     HTN never develop HF-PSF or which specific aspects of HTN predispose to HF-PSF.~      In the Dahl S rat, the primary animal model of HF-PSF, high dietary sodium intake suppresses~     the systemic renin-angiotensin-aldosterone system, but upregulates renal and cardiac~     renin-angiotensin-aldosterone system by inducing oxidative stress. In humans, the magnitude~     of blood pressure response to sodium ingestion and depletion can categorize subjects as~     salt-resistant and salt-sensitive. Human salt sensitivity is associated with structural~     and loading conditions that increase the risk for HF-PSF, including HTN, ventricular~     hypertrophy and diastolic dysfunction, arterial stiffening, and increased plasma volume. High~     dietary sodium intake induces oxidative stress in salt-sensitive humans. In humans with HTN~     and normal ventricular systolic function that do not have heart failure, increased oxidative~     stress predicts impaired exercise capacity, ventricular hypertrophy, diastolic dysfunction,~     arterial stiffening, and vascular endothelial dysfunction. The investigators have proposed~     that salt sensitivity and the accompanying oxidative stress on the typical high-sodium~     Western diet may contribute to the initiation and progression of HF-PSF.~      In patients with HF-PSF, the investigators will relate dietary changes to biochemical and~     cardiovascular functional measures. The investigators will study subjects on ad-lib diet and~     and following three weeks of rigorous dietary modification with the Dietary Approaches to~     Stop Hypertension (DASH)/sodium-restricted diet (SRD). This diet is richer in natural~     antioxidants and lower in sodium than the usual American diet. The DASH/SRD is recommended to~     lower blood pressure in patients with HTN, and is particularly effective in elderly, obese,~     and salt-sensitive hypertensives. Dietary sodium restriction is recommended for all HF~     patients including those with HF-PSF. The investigators hypothesize that the DASH/SRD will~     have favorable effects on oxidative stress, ventricular and vascular function, and blood~     pressure control in patients with hypertensive HF-PSF.~   "
200401|NCT00939627|"~     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow~     to the tumor. It is not yet known whether cetuximab is more effective when given alone or~     together with sorafenib tosylate in treating patients with head and neck cancer. This~     randomized phase II trial is studying cetuximab to see how well it works when given together~     with or without sorafenib tosylate in treating patients with refractory, recurrent, and/or~     metastatic head and neck cancer.~   "
200402|NCT00939614|"~     -  Objective:~             -  A randomized, open label, two treatment, two period, two sequence, single dose,~               crossover, bioequivalence study of Lamotrigine 2 x 25mg IR tablets of Torrent~               Pharmaceuticals Limited, India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of~               Glaxo-SmithKline, USA, in healthy human adult subjects, under fasting conditions.~        -  Study Design:~             -  Randomized, open label, two treatment, two period, two sequence, single dose,~               crossover, in 24+2 healthy human adult subjects to compare the single dose~               bioavailability of Torrent's Lamotrigine Tablets 2 × 25 mg and Lamictal® Tablets 2~               × 25 mg of GlaxoSmithKline. Dosing periods were separated by a washout period of at~               least 21 days.~   "
200403|NCT00939601|"~     Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops~     breathing or experiences shallow breathing for short periods of time during sleep. The most~     common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine,~     but many people have trouble adhering to the treatment schedule. This study will evaluate the~     effectiveness of two behavioral therapy programs used in combination with CPAP for improving~     treatment adherence in people with OSA.~   "
200404|NCT00939588|"~     This study is designed as a mechanistic study to compare the effect of two different~     combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and~     ramipril) on the renin-angiotensin-aldosterone system (RAAS) in patients with moderate~     hypertension.~   "
200419|NCT00939393|"~     Endoscopic sinus surgery will be performed either in the physician's office or in the~     operating room (OR). Patients treated in the physician's office will have endoscopic sinus~     surgery performed with balloon sinuplasty devices. Patients treated in the OR will have~     endoscopic sinus surgery performed with or without balloon sinuplasty devices.~   "
200681|NCT00935948|"~     The aim of our study was to assess the clinical efficacy and safety of the drug Imescard~     compound water smartweed, adrenalin and hamamelis ointment in the treatment of hemorrhoidal~     disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.~   "
200405|NCT00939575|"~     The hypertensive disorders of pregnancy are the medical complications more prevalent during~     pregnancy. In Canada, approximately 1% of pregnancies have complications due to a~     pre-existing hypertension, 5-6% because of hypertension of pregnancy without proteinuria and~     1-2% by preeclampsia. Metabolomics involves a new technology to investigate small molecules~     that characterize biochemical pathways of interest. The change in concentration levels of~     these molecules in various biological samples such as urine and blood in the presence of a~     disease or a patient can be particularly useful for identifying new biomarkers. Our~     hypothesis is that metabolic patterns in blood and urine of pregnant women who had~     preeclampsia differ from the metabolomics patterns of patients without preeclampsia.The whole~     research program has two complementary objectives in order to expect a decrease of~     prematurity: a) better understanding of all the physiological mechanisms leading to~     prematurity and b) better identification of patients at high risk for a better management of~     these women.~   "
200406|NCT00939562|"~     The purpose of this protocol is to study if two different tablet formulations of doxycycline~     are bioequivalent to each other.~   "
200407|NCT00939549|"~     The purpose of this study is to determine if high-dose cyclophosphamide followed by a~     maintenance dose of glatiramer acetate is safe in patients with relapsing remitting multiple~     sclerosis (MS). The investigators hypothesize that institution of glatiramer acetate~     treatment following high-dose cyclophosphamide treatment will extend the period of disease~     free activity and further reduce the disability in patients with relapsing remitting multiple~     sclerosis. The investigators plan to investigate the properties of glatiramer acetate against~     the recurrence of MS disease activity following high dose cyclophosphamide induced cessation~     detectable autoimmunity. The investigators hypothesize that glatiramer acetate, given in the~     phase of immune reconstitution after high-dose cyclophosphamide, may bias the immune system~     to a more tolerated state, thus leading to more stable and potentially permanent remissions.~   "
200408|NCT00939536|"~     -  Objective:~             -  To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test~               Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited,~               India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured~               by Sanofi- Synthelabo Inc. under fasting conditions in 24 healthy, adult, human~               subjects.~        -  Study Design:~             -  Open label, randomized, two-period, two-treatment, two-sequence single dose~               crossover design.~   "
200409|NCT00939523|"~     PURPOSE~      The drug Lapatinib has been shown to inhibit both epidermal growth factor receptor (EGFR) and~     erbB2 tyrosine kinases resulting in an effective slowing of disease progression in breast~     cancer. It has also been demonstrated that erbB is overexpressed in human pituitary adenomas.~     The investigators are therefore assessing tumor size stabilization and pituitary tumor~     secretory profiles during the course of a six month therapy of lapatinib. The purpose of this~     trial will be to estimate the activity of lapatinib in slowing the growth rate of pituitary~     tumors. Lapatinib is an FDA approved drug used to treat breast cancer. However, in this~     study, the drug will be used to treat pituitary cancer.~      STUDY POPULATION~      This study will recruit patients from the Pituitary Center at CSMC who are over the age of 18~     that have a recurrent nonfunctioning adenoma after at least one surgical resection as well as~     patients with prolactinomas who are resistant to dopamine agonist therapy and patients with~     recurrent Cushing's disease.~      PARTICIPANT'S JOURNEY THROUGH THE RESEARCH~      The principal investigator (PI) or co-investigator will determine patients' potential~     eligibility for the study based on inclusion and exclusion criteria.~      The PI or the co-investigator will then approach subjects with recurrent nonfunctioning~     adenomas or prolactinomas resistant to dopamine agonist therapy or recurrent Cushing's~     disease during a visit in the clinic office and ask if these subjects would be interested in~     participating in this study. If the subjects express interest, they will be given the consent~     form to review. They will be encouraged to review it with family, friends, and/or other~     physicians. The PI, co-investigators, or research nurse will be available for any questions~     the subjects might have. If the subjects are still interested, they will be asked to sign and~     return the consent form to the office and a study visit will be scheduled.~      The PI, co-investigator, or member of study staff may also attempt to contact current~     patients by phone to assess interest in participating in the study. The purpose and overall~     structure of the study will be discussed with the possible participant. They will be reminded~     that the study is strictly voluntary and that their involvement or disinterest in the study~     will not affect their ongoing care. If the patient is interested they will be mailed a~     consent to review and will be asked to call the center to schedule an appointment to further~     discuss the study if they decide they are interested.~      Each participant will undergo 8 visits of the course of the study. Each participant will have~     a baseline visit where a medical history will be taken, a physical, visual field test,~     electrocardiogram (ECG), echocardiogram (ECHO), and blood draw will be performed. At this~     point lapatinib therapy will begin and the patients will be asked to take the drug daily for~     the next six months. Patients will take Lapatinib 1250 mg daily (orally), which is the~     standardized dose used to treat breast cancer patients. Visit 2 will be 1 month after the~     participant has started lapatinib. At visit 2 all participants will receive a physical exam,~     a history will be taken, an ECG will be performed, and a blood draw will occur. Visit 3 will~     be 2 months after starting lapatinib. A physical exam and history will be performed along~     with an ECG and echocardiogram and blood draw. Visit 4 will be 3 months after starting~     lapatinib. A physical, history, blood draw, ECG, visual field test, and a magnetic resonance~     imaging (MRI) of the pituitary will be performed. Visit 5 will occur 4 months after starting~     lapatinib. A physical exam and history along with a blood draw and ECG and echocardiogram~     will occur. Visit 6 will be 5 months after starting lapatinib. A physical exam, history, ECG,~     and a blood draw will occur. Visit 7 will occur 6 months after the start of lapatinib. A~     physical exam, history, blood draw, visual field test, ECG, echocardiogram and MRI of the~     pituitary will occur. At this point lapatinib will be discontinued. Visit 8 will occur 1~     month after visit 7 and a physical exam, history, blood draw, and ECG and and echocardiogram~     will occur.~   "
200410|NCT00939510|"~     RATIONALE: Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the~     tumor. GM-CSF may stimulate the immune system in different ways and stop tumor cells from~     growing. Giving lenalidomide together with GM-CSF may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide~     when given together with GM-CSF and to see how well it works in treating patients with~     prostate cancer.~   "
200411|NCT00939497|"~     Objective:~        -  To assess the bioequivalence of Risperidone 1.0 mg tablets of Torrent Pharmaceuticals~          Limited., India and Risperdal® (Risperidone) 1.0 mg tablets of Janssen Pharmaceutical~          Products, LP, USA, in healthy human adult subjects, under fasting conditions.~      Study Design:~        -  A randomized, open label, two treatment, two period, two sequence, single dose,~          crossover study, under fasting conditions.~   "
200412|NCT00939484|"~     This phase II trial is studying how well vismodegib works in treating adult patients with~     recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells and~     may be an effective treatment for medulloblastoma.~   "
200413|NCT00939471|"~     A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety~     and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis~     following failed medical management.~   "
200414|NCT00939458|"~     -  Objective:~             -  To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent~               Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of~               Glaxo-SmithKline, USA, in healthy human adult subjects, under fed conditions.~        -  Study Design:~             -  A randomized, open label, two treatment, two period, two sequence, single dose,~               crossover study, under fed conditions.~   "
200415|NCT00939445|"~     1. To compare the efficacy of~        1. Short Daily Hemodialysis~        2. Online HDF in term of adequacy of dialysis.~   "
200416|NCT00939432|"~     Objective/study hypothesis To evaluate how much of a taboo UI is and how it compares to other~     medical conditions that may also pose a taboo issue like depression and cancer.~      Background Urinary incontinence (UI) is a highly prevalent condition with more than 200~     million people worldwide being affected. While physical health does not necessarily have to~     be impaired much, restriction of social activities leads to isolation, a significant~     reduction in quality of life and will often bring about subsequent morbidity. Despite its~     prevalence, many patients suffering from UI go undiagnosed and untreated. Patients often~     hesitate to report the problem, and health care professionals often do not ask about it. In a~     study Minassian (2003) estimated that just one in four patients actively seeks medical~     attention. The reason for this may lie in the shame, embarrassment, and stigma associated~     with this condition, which in turn pose significant barriers to seeking professional~     treatment. Although mentioned by many narrative reviews and included in some epidemiological~     papers on UI, surprisingly we found no data addressing the taboo of UI exclusively. The aim~     of our study therefore was~      Methods/Design A 13-question self-administered questionnaire was developed and face validity~     tested by 2 of the authors (KH, EH). The anonymous questionnaire contained simple questions~     on gender and age and then asked yes/no questions on whether test persons knew people with~     UI, or suspected other people to be incontinent, if they would address this issue with the~     suspected person, and if they thought that UI was a taboo issue in the society. On a scale~     from 0 - 10 they were then asked to grade the amount of embarrassment and anxiety if they~     themselves were incontinent, compared to depression or cancer. A few questions on knowledge~     of the condition of UI and to whom test persons would turn to in case of UI concluded the~     short questionnaire, which took about 5 minutes to fill in. A convenience sample of 150 test~     persons from waiting areas of a teaching hospital and in private practices of general~     practitioners in Austria agreed to take part in the study, with an additional 10 persons~     (6.2%) declining after being informed about the subject. Data were analysed with the SPSS~     10.0.5 software package using the U-test, Chi-square-test, Yates-correction, Fisher's exact~     test and Kolmogorov-Smirnov normality test where appropriate.~   "
200417|NCT00939419|"~     The purpose of the study is whether the provision of tuberculosis care using volunteer~     community health workers or self-administered treatment for 7 months is equally effective~     with the existing 8 months of TB care in public health facilities by health workers. Patient~     care by volunteer community health workers and 7 months of self-administered treatment are~     more patient-convenient delivery options than the ongoing TB care in health facility.~   "
244823|NCT00349401|"~     The purpose of this study is to determine how the drug ketorolac, when given with the spinal~     morphine, affects pain.~   "
200420|NCT00939380|"~     The investigators have developed a parent social-cognitive processing intervention (P-SCIP)~     to help decrease distress among parent caregivers of children undergoing hematopoietic stem~     cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing~     short- and long-term distress and parenting stress among 300 parents of children undergoing~     HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is~     specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g.,~     acceptance) processing of the transplant experience. The intervention includes five in-person~     sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials~     in the in-person sessions and provides parents with the opportunity to enhance and deepen~     their cognitive and social processing of the HSCT experience. The intervention will be tested~     against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT~     settings across the United States. P-SCIP will be provided to both Spanish- and~     English-speaking parents. Participants will complete measures of psychological distress,~     well-being, and social and cognitive processing at the time of HSCT, two, six and twelve~     months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent~     psychological adaptation and social and cognitive processing, as well as evaluate parent~     personal resources as well as child medical course variables that contribute to intervention~     response. The investigators will also examine barriers to participation in the intervention~     by comparing barriers to participation among parents who refuse participation in the trial~     and parents who accept.~   "
200421|NCT00939367|"~     -  Objective:~             -  To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test~               Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited,~               India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured~               by Sanofi- Synthelabo Inc. under fed conditions in 30 healthy, adult, human~               subjects in a randomized crossover study.~        -  Study Design:~             -  Open label, randomized, two-period, two-treatment, two-sequence single dose~               crossover design.~   "
200422|NCT00939354|"~     This study will investigate the importance of exhaled nitric oxide measurements in subjects~     with asthma age 65 and older. This group of patients has been ignored in most previous asthma~     studies.~   "
200423|NCT00939341|"~     The purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy~     (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a~     real life situation.~   "
200424|NCT00939328|"~     RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help~     kill them or carry cell-killing substances to them. Giving bendamustine together with~     rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects of giving bendamustine together~     with rituximab and to see how well it works in treating patients with B-cell chronic~     lymphocytic leukemia that has not responded to previous treatment.~   "
200425|NCT00939315|"~     The aim of this study is to establish the diagnostic value of~     O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) PET-CT, [18F]-fluorocholine (FCH) and magnetic~     resonance imaging (MRI) combined with magnetic resonance spectroscopy (MRS) in patients with~     suspected cerebral glioma using neuronavigated biopsies with histopathological analysis as~     reference.~   "
200426|NCT00939289|"~     The purpose of this pilot study is to evaluate performance of the SEVEN System and the~     Navigator System when both devices are worn concurrently by subjects with type 1 diabetes~     mellitus.~   "
200427|NCT00939276|"~     The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who~     developed macular edema (ME) within 90 days following cataract surgery.~   "
200428|NCT00939263|"~     Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus affecting~     children and adults. The most frequent symptoms are swallowing difficulties and thoracic~     pain. The disease has first been described in the 1980s and is found with rapidly increasing~     frequency mainly in industrialized countries. The factors that lead to EoE are until now~     incompletely understood, of importance, the disease is found more frequently in men and~     patients suffering from allergic diseases (e.g., Asthma). So far there exists no activity~     index to define the severity of EoE; such an index is urgently needed for future clinical~     trials to determine the efficacy of current and future therapies. The investigators' 3-year~     project, carried out in cooperation with international EoE experts, aims at the development~     of an activity index for adult and pediatric EoE patients that will be used in future~     clinical trials as well as observational studies.~   "
200429|NCT00939250|"~     The study involves a 32-week randomized controlled trial in primary care of a comprehensive~     diabetic and depression intervention in patients with type 2 diabetes and comorbid MDD,~     compared to a group treated with usual care for MDD plus disease self-management and~     measurement-based care for diabetes.~   "
200430|NCT00939237|"~     The purpose of this study is to determine whether Ateronon, a nutritional supplement that~     contains lycopene from tomatoes has a favorable effect on carotid atherosclerosis, lipid~     levels, and other biomarkers of coronary heart disease.~      The trial was stopped early due to insufficient financial support from the initial study~     collaborator, Cambridge Theranostics Ltd. Collected patient data are sufficient for final~     trial-based analyses to be conducted with financial support from the new study collaborator,~     CamNutra Ltd. The data will still be analyzed according to the original study aims.~   "
200431|NCT00939224|"~     The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device~     to measure regional oxygen saturation in a cohort of children with cardiovascular disease~     undergoing cardiac catheterization.~   "
200432|NCT00939211|"~     Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with~     deteriorating lung function over the years. Patients with COPD experience symptoms of~     shortness of breath, cough and sputum production. This study is to assess the treatment~     effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg)~     and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator.~     25 patients are to participate in the study and all will be recruited in Sweden. Each patient~     will visit the study doctor 9 times during the study, whereof 5 visits will be overnight~     visits. All examinations, treatment and the follow-up is free of charge.~   "
200433|NCT00939198|"~     Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life~     cycle. In a clinical study in previously hookworm-infected adults in Brazil, this protein~     induced urticarial reactions (rash) in a subset of volunteers. The clinical trial component~     of this study involves skin testing for immediate-type hypersensitivity to the Na-ASP-2~     Antigen. Both prick-puncture and intradermal tests will be applied.~   "
200434|NCT00939185|"~     The objective of this study was to obtain data on the safety, tolerability and compliance~     with Zithromax in children with bacterial infections of the upper and lower respiratory~     tract.~   "
200435|NCT00939172|"~     The goal of this clinical research study is to find the highest tolerable dose of TTP607 that~     can be given to patients with a solid tumor or lymphoma. The safety of TTP607 will also be~     studied.~      Researchers will also do pharmacokinetic (PK) testing of TTP607. PK testing measures the~     amount of a drug in the body at different time points.~   "
200436|NCT00939159|"~     The goal of this clinical research study is to learn if LBH589 can help to control lower-risk~     (low or intermediate-1 risk) MDS. The safety of this drug will also be studied.~   "
200437|NCT00939146|"~     This study will demonstrate whether an end-of-life preparation and completion intervention~     reduces anxiety, depression, pain and other symptoms and improves functional status,~     spiritual well-being, and quality of life. If effective, the intervention offers a brief,~     inexpensive, and transportable non-physician treatment method for improving the experience of~     individuals in the latter stages of life-limiting illness.~   "
200438|NCT00939133|"~     The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the~     progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for~     non-inflammatory papules and comedones to recur. However, there has been no formal study to~     look at the prevention of recurrence of these acne lesions post isotretinoin in a long term~     basis. This may enhance the therapeutic options for post isotretinoin patients in order to~     prevent recurrence of their disease.~      Hypothesis Tretinoin microsphere 0.04% will prevent recurrence of acne lesions.~   "
200439|NCT00939120|"~     This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride~     given for 18 months, including a 1-year double-blind randomized co-administration with either~     tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including~     urgency and frequency, with or without urgency urinary incontinence (i.e., overactive bladder~     (OAB) symptoms).~   "
200440|NCT00939107|"~     Introduction:~      The McKenzie method as well as spinal manipulation is commonly used for the treatment of low~     back pain throughout the western world. Recently, the need for studies testing the effect of~     treatment strategies to specific diagnostic subgroups of patients has been emphasized. The~     present study aims to compare the effectiveness of the McKenzie method and chiropractic~     manipulation, information, and advice for patients with clinical signs of persistent symptoms~     originating from a diskus in the low back.~      Methods:~      After clinical screening 350 patients with or without leg pain who presented with~     centralization of symptoms or signs of disc herniation were randomized to the McKenzie group~     or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11~     point numerical pain scale, 6 point global perceived change scale, and quality of life (Short~     Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.~   "
200441|NCT00939094|"~     The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to~     placebo can relieve the pain arising from the nervous system when the patients are touched by~     something that should not cause pain or have severe pain when they are touched by something~     that should only cause a little pain.~   "
200442|NCT00939081|"~     The purpose of this study is to examine whether pedometer step count recommendations (10,000~     steps/day versus an adaptive recommendation) are differentially associated with the primary~     outcome of adherence to the pedometer-based physical activity regimen and the secondary~     outcomes of change in physical activity and body mass index (BMI).~   "
200443|NCT00939068|"~     The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy~     for the prevention of HBV perinatal transmission in highly viraemic mothers.~   "
200444|NCT00939055|"~     The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a~     small gastric pouch and rearrangement of the small intestine. Although RNYGB has been~     demonstrated as an effective bariatric procedure, a significant number of patients experience~     weight regain that is often associated with distended gastric anatomy. Open and laparoscopic~     approaches for revision are associated with higher complication rates than de novo~     procedures. This study will evaluate the safety and effectiveness of a revisional~     incisionless natural orifice surgery of the gastric pouch and stoma in producing weight loss~     in post-RNYGB patients who have experienced weight regain.~   "
200445|NCT00939042|"~     Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy~     concerning left ventricular ejection fraction as measured by echocardiography.~   "
200446|NCT00939029|"~     Smokeless tobacco use (chewing) is associated with negative health effects. To date, no~     medications have been shown to help chewers quit long-term. High dose nicotine patch therapy~     may improve the chances that chewers can quit for good. If found to be effective, chewers may~     use this treatment to help them quit and reduce their risk for negative health effects.~   "
200447|NCT00939016|"~     The purpose of this study is to evaluate the influence of dietary restraint, social~     desirability, and food type on the accuracy of dietary intake reported during a 24-hour~     recall.~   "
200448|NCT00939003|"~     This study will evaluate how well adalimumab works in the short and long term in patients~     with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or~     psoriatic arthritis.~   "
200471|NCT00938704|"~     To compare the efficacy and safety of two non-preserved artificial tears,~     (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the~     treatment of the signs and symptoms of dry eye disease.~   "
200504|NCT00938275|"~     The primary objective of this study is to assess the pharmacokinetic profile of a single 500~     mg dose of SRT2104 administered as an oral suspension and a capsule formulation to normal~     healthy male and female volunteers in both the fed and fasted state.~      The secondary objective is to assess the safety and tolerance of SRT2104 administered as an~     oral suspension and as a capsule formulation to healthy male and female volunteers in both~     the fed and fasted state.~   "
200449|NCT00938990|"~     Rationale: The drug etomidate causes increased mortality if used for continuous sedation in~     mechanically ventilated patients; however, etomidate continues to be widely used as a~     single-bolus induction agent for endotracheal intubation because of its favorable hemodynamic~     properties. Recent data have raised questions regarding the safety of using etomidate for~     even a single bolus in patients at risk of adrenal insufficiency, emphasizing the fact that~     single bolus doses of etomidate cause measurable adrenal suppression, and consequently may~     cause increases in vasopressor requirements and in hospital length of stay. Alternative~     FDA-approved induction agents, such as midazolam, may be safer than etomidate; however, no~     studies have formally compared these agents.~      Research Hypothesis: The investigators hypothesize that in critically ill trauma patients~     presenting to the emergency department requiring rapid sequence intubation, the hospital~     length of stay for patients given etomidate will be greater than for patients given midazolam~     for induction.~      Specific Aims: The specific aim is to determine the difference in hospital length of stay~     between trauma patients given etomidate and those given midazolam for induction during rapid~     sequence intubation in the emergency department. The investigators plan to compare the two~     groups in terms of hospital length of hospital stay, length of stay in the intensive care~     unit, and duration of intubation by performing a prospective, randomized, trial of critically~     ill trauma patients presenting to the emergency department requiring intubation. The~     investigators will also compare the mortality rates in these two groups while controlling for~     severity of illness and the use of steroids while hospitalized.~      Significance: If the use of etomidate to induce anesthesia prior to intubation adversely~     affects the hospital length of stay of trauma patients, this length of stay might be reduced~     in such patients by using alternative agents for induction. Since etomidate is currently in~     widespread use as an induction agent, the results of this study could have significant~     implications for patient management.~   "
200450|NCT00938977|"~     Main objective:~      To describe clinical and functional characteristics of the obese hypoventilating patient; to~     study the relation between the obesity-hypoventilation syndrome (OHS) and the obstructive~     sleep apnea hypopnea syndrome (OSAHS). In the second stage of the study, to assess patient~     response to non-invasive mechanical ventilation (NIV) and continuous positive airway pressure~     (CPAP), and to identify predictors of unfavourable response to treatment.~      Methodology:~        -  Patients: Patients with obesity degree I-III, with pCO2 awake and at rest > 45 mmHg,~          with no underlying pulmonary or neuromuscular lung disease; two control groups, one of~          non-hypoventilating obese patients and the other of obese patients with OSAHS, will also~          be studied over the same period.~        -  Design: Prospective observational study. In the first stage anthropometric, clinical,~          functional and metabolic data will be recorded for the obese hypoventilating patients~          and the two control groups (obese patients without respiratory pathology, and obese~          patients with OSAHS).~      In the second stage patients with OHS will be divided into two subgroups: group 1: patients~     with polysomnography (PSG) suggestive of hypoventilation, in whom NIV treatment will be~     initiated; group 2: patients with PSG suggestive of OSAHS (apnea-hypopnea index >15), who~     will be administered CPAP. Patients will be examined one month and three months after the~     start of treatment. The same measurements will be carried out as at the beginning of the~     study, with the exception of the polysomnographic study. Nonetheless, pulse oximetry and~     arterial gases will be performed on waking.~      Expected Results:~      Patients with OHS may be characterized and differentiated from obese patients without~     associated respiratory pathology on the basis of clinical, functional and metabolic data.~      There is a group of patients with association between OSAHS and OHS that do not respond to~     treatment with CPAP, and this unfavorable response can be predicted in advance.~   "
200451|NCT00938964|"~     The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a~     decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is~     commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking~     nerves). The investigators are enrolling subjects in this research project to see if~     lidocaine will reduce the high incidence of cognitive injury seen after heart surgery. As~     part of this study, the investigators will also evaluate the relationship between cognitive~     injury and genetic makeup and the chemical changes in the subjects blood during and after~     surgery.~   "
200452|NCT00938951|"~     The primary objective of this study is to compare visual degradation in a stressed (forced~     stare) environment in patients before and after acute administration of Systane Ultra.~   "
200453|NCT00938938|"~     The purpose of this study is to test the effect of adding a press guide to standard~     materials that journalists routinely receive regarding research published in medical~     journals.~   "
200454|NCT00938925|"~     Onychomycosis occurs in more than 50% of all pathologies unguinal, affecting the health and~     quality of life of the patient. Although the investigators have a wide therapeutic arsenal,~     there is still a disparity when carrying out an effective processing.~      Hypothesis/Objectives:~      To analyze if the use of the podiatric technique of aggressive unguinal abrasion with~     micrometer sports, in combination with topical treatment with amorolfin 5% in hairspray,~     significantly increases the effectiveness clinically as well as mycology.~      The investigators will analyze the relationship between this intervention and the quality~     perception of life related to the health of the nails and the foot.~      The investigators will Use results for next validation study in Spanish of the questionnaire~     NailQoL, as well as validation and reliability of the index SCIO and cost study-effectiveness~     of the processing.~      Method:~      The investigators will design a randomized control trial. The town will be recruited,~     informed prior consent will be obtained from patients of 5 Spanish centers of chiropody, with~     sample size of 313 patients. There will be a screening of 4 weeks to select patients with~     onychomycosis infections (clinic and mycology both positives); later the patients will be~     distributed randomly in 2 groups:~        -  GROUP AM+AU: Will be administered aggressive unguinal abrasion, weeks 0 (baseline), 12~          and 24, followed by standard treatment of amorolfin 5%, two weekly applications during~          36 weeks.~        -  GROUP AM: Will be administered exclusively standard treatment of amorolfin 5%, according~          to common format. The duration will be 48 weeks.~   "
200455|NCT00938912|"~     SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in~     children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as~     adjunctive therapy.~   "
200456|NCT00938899|"~     The purpose of this study is to examine the safety, tolerability and pharmacokinetics of~     increasing oral doses of TMC435350 after single and repeated dosing, followed by an open~     label repeated dosing session in 6 HCV genotype1 infected patients.~   "
200457|NCT00938886|"~     To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking~     cessation outcomes in heavy drinkers seeking smoking cessation treatment.~   "
200458|NCT00938873|"~     Mindfulness based cognitive therapy (MBCT) is a group psycho-educational treatment designed~     to reduce the risk of recurrent depression by integrating mindfulness based meditation~     practices with cognitive therapy techniques. MBCT comprises eight weekly two-hour group~     sessions. Additionally, participants are required to commit to one hour per day of between~     sessions meditative homework assignments six days per week. Existing quantitative research~     suggest that MBCT is an effective intervention for preventing depressive relapse in patients~     with three or more episodes of depression (Teasdale et al.2000, Ma & Teasdale, 2004). The~     focus of qualitative research has been on evaluating the acceptability of MBCT for various~     clinical populations; participants' accounts have been positive indicating MBCT may be a~     potential therapeutic tool for treating older adults (Graham & Senthinathan, 2007), psychosis~     (Abba, Chadwick, & Stevenson, 2008), Parkinson's disease (Fitzpatrick, Simpson, & Smith,~     2010) as well as acute depression (Mason & Hargreaves, 2001).~      The benefits of undertaking meditative mindfulness practice in the context of MBCT have been~     linked to changes in metacognitive processes. Two distinct multi-level information processing~     frameworks dealing with how thoughts are processed from a metacognitive perspective have been~     proposed: The Interacting Cognitive Subsystems (ICS; Teasdale, 1999a, 1999b) and the Self~     Regulatory Executive Function (S-REF; Wells, 2000) theory. The ICS framework forms a~     rationale for meditative aspects of the MBCT programme. The S-REF model differs from the ICS~     theory in its conceptualisation of the object or 'being' mode of metacognitive processing.~      Regular daily practice of mindfulness meditation has been regarded as among the most~     essential aspects of mindfulness programmes (Kabat-Zinn, 1990; Mason & Hargreaves, 2001).~     Existing studies, with their focus on effectiveness or acceptability of MBCT as an~     intervention, have thus far excluded an important aspect of the course involving the~     experience of meditative homework assignments. Therefore, the aim of this study was to~     explore subjective accounts of the meaning of carrying out meditative homework assignments in~     the context of a National Health Service (NHS) run MBCT course. The research questions~     focused on the impact of meditative homework on thought processes as well as an exploration~     of barriers and facilitating factors from a participant's perspective.Six individual in-depth~     interviews were conducted with participants all of whom had completed the full MBCT~     programme. Interpretive phenomenological Analysis (IPA) was used as the methodology for~     analysing interview transcripts. Data analysis began with a detailed examination of one case~     until a thorough analysis was completed after which subsequent cases were analysed. Finally a~     cross case analysis was carried out where individual themes were interrogated for~     similarities and differences (Smith, et al., 2009).~      Two master themes were presented: 'The relationship of meditative homework to metacognitive~     experience' and 'Motivating and discouraging factors for engagement in meditative practice'.~     Results reveal a transformation in metacognitive processes as a result of undertaking~     meditative homework. The subjective experience of metacognitive processes is examined in the~     context of existing psychological theories including the ICS (Teasdale, 1999a, 1999b) as well~     as the S-REF (Wells, 2000) theory involving metacognitions. A model for perceived~     facilitating factors and difficulties experienced in carrying out meditative homework is~     constructed based on the Integrated Theoretical Foundations Model for CBT homework assignment~     (Kazantzis, et al., 2005). The model explores participants' motivation in three stages of the~     homework process: firstly during assignment of the meditative homework task, secondly in~     completing the planned task and finally carrying out review of the task in question.~     Implications of the present study are discussed in relation to psychological literature,~     homework assignment and the practise of MBCT.~   "
200459|NCT00938860|"~     This study will assess the rates of Sustained Virological Response following anti-viral~     therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with~     recurrent Hepatitis C and treated with Neoral or tacrolimus.~   "
200460|NCT00938847|"~     Evaluative pilot study for safety and feasibility with administration of autologous bone bone~     marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo~     the ischemic lesion.~   "
200486|NCT00938509|"~     The study will evaluate the efficacy of Ibuprofen administered as suppositories in the~     treatment of fever in infants and children. Ibuprofen as suppositories is not yet registered~     in Israel, although widely used in Europe.~   "
200487|NCT00938496|"~     This is a prospective, open label NIS, which is to assess the efficacy of Zoladex in adjuvant~     setting after operation in moderate to severe endometriosis patients.~   "
200488|NCT00938483|"~     The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with~     cow's milk allergy.~   "
200461|NCT00938834|"~     Fibromyalgia is a syndrome characterized by widespread musculoskeletal pain and hyperalgesia~     with a prevalence of 2-4% in the general population; it is often accompanied by fatigue,~     insomnia, anxiety, depression and other conditions. It is a difficult condition to treat, and~     only recently have drugs been approved by the FDA specifically for the treatment of this~     condition (Lyrica was approved in 2007, Duloxetine in 2008). There are now several clinical~     trials of drugs commonly used to treat neuropathic pain (amitriptyline, gabapentin,~     pregabalin, acetaminophen/tramadol, duloxetine, minserin) reporting some degree of efficacy~     in treating fibromyalgia. This efficacy makes it practical to consider fibromyalgia along~     with other neuropathic pain conditions. However, such drug trials report only partial~     efficacy in relieving pain and/or other symptoms. Current treatment recommendations indicate~     the need for a multimodal approach; this includes medical management using appropriate drug~     therapies, psychological therapies, exercise and complementary approaches. The current~     proposal is for a randomized controlled trial to compare qigong (a complementary modality) to~     a wait list control to determine if qigong is a useful complementary therapy for~     fibromyalgia.~      The investigators recently completed a pilot trial in which they examined a specific form of~     qigong (CFQ Qigong, available locally in Halifax), and observed beneficial effects against~     pain, fibromyalgia impact, and on quality of life scores; importantly, these benefits were~     all sustained for 6 months to the end of the trial. On the basis of these preliminary~     observations, the investigators now propose a controlled trial in which CFQ Qigong is~     compared to a wait list control group. The latter group will be offered qigong training at~     the end of the trial, so could really be characterized as a delayed treatment group. The~     study will consist of a 3-day training period, weekly review of technique sessions for 8~     weeks, daily practice for 8 weeks, with assessments at baseline, at 8 weeks following the~     training and practice, and follow-up assessments at 4 and 6 months. Study outcomes will~     include: (a) pain (numeric rating scale - pain intensity), (b) impact (fibromyalgia impact~     questionnaire), (c) quality of life measures (SF-36), (d) patient assessments (patient global~     impression of change and satisfaction scales), (e) sleep measures (Pittsburgh sleep quality~     index, actigraphy, sleep diary). In addition to these assessments, the investigators will~     also conduct qualitative assessments in which participants provide a more open-ended~     assessment of their health status at these same intervals. The main hypothesis being examined~     is that CFQ Qigong will produce benefits compared to the wait list group.~   "
200462|NCT00938821|"~     This is a chart review. The aim of this study is to investigate the effectiveness and side~     effects of very low dose morphine administered caudally to children that went to surgical~     procedures that used caudal anesthesia. The study compares caudal block with Bupivacaine (1~     ml kg_1 of bupivacaine 0.25% and saline 0.02 ml kg_10) with very low dose morphine (a mix of~     1 ml kg_-1 of ropivacaine 0.2% and preservative-free morphine: 10 µg kg-1).~   "
200463|NCT00938808|"~     Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.~      The two diseases intertwine in several ways. The evolution in the population shows a tendency~     towards deterioration of both by increasing general age and weight. The two diseases share~     pathogenetic features and the development of one disease increases the risk of the other and~     may be the onset of a vicious circle.~      There is a link between treatments of these two diseases as well. There is now solid (gold)~     evidence that by treating effectively the obesity of patients with co-occurring OA, the~     functional status is dramatically ameliorated; the short-term results are equal to that of a~     joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is~     definitely one of many diseases in which obesity must be taken seriously into account when~     planning a correct treatment of patients. This trial is an extension of the former CAROT~     trial NCT00655941. The participants of this trial are recruited for a prolongation of the~     dietary intervention consisting of a group therapy with low-energy diet in a randomized, two~     group (each n = 75 patients) study of maintenance of weight loss by continuing with~     supplementary either 3 x 5 weeks dietary supplements only or once-daily supplement. The~     hypothesis is that maintenance of the already induced weight loss is most efficiently ensured~     by the once-daily program.~   "
200464|NCT00938795|"~     The goal of this study is to improve symptoms and quality of life for end-stage liver disease~     patients awaiting a liver transplant and their caregivers by providing them with the~     resources and tools to self-manage their complex concerns.~   "
200465|NCT00938782|"~     Asses the effect of the use of Patient State Index (PSI) monitoring on difference in~     emergence profiles in the elderly (age >65 yrs) population to develop a cost-benefit profile.~      Assess differences in Quality of Life using the QoR-40 (a validated 40-item questionnaire on~     quality of recovery from anesthesia) between the two treatment groups.~   "
200466|NCT00938769|"~     The goal of this study is to examine the effects of an enhanced caregiver training protocol~     that not only teaches informal caregivers knowledge and skills for managing patient symptoms,~     but also provides strategies for managing their own psychological distress. The investigators~     anticipate this training will increase caregivers' self-efficacy and improve important~     caregiver outcomes (depression, anxiety, burden, quality of life) and patient outcomes~     (symptom distress/intensity, depression, anxiety, and quality of life). The study will~     compare the effects of this protocol to an education control condition that equates for~     interventionist time and attention.~   "
200467|NCT00938756|"~     RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal~     syndrome may help doctors identify biomarkers related to cancer.~      PURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing~     carcinomatous meningitis in patients with cancer or meningeal syndrome.~   "
200468|NCT00938743|"~     According available data individuals with ADHD are impaired in their driving ability which~     can be improved by stimulant medication. The impact of the specific~     noradrenalin-reuptake-inhibitor atomoxetine on driving ability of patients with ADHD has~     never been studied so far.~      The present study aims to evaluate the effects of atomoxetine treatment in patients with ADHD~     on practical driving abilities which will be assessed with a standardized driving test, a~     structured one-week driving diary and driving related neuropsychological processing~     especially different aspects of attention and executive functions which will be assessed with~     a neuropsychological test battery designed for the assessment of drivers fitness. A~     functional magnetic resonance imaging (fMRI) - investigation will also be performed at the~     beginning and after a 10-week treatment with atomoxetine. The study will be conducted in a~     single-blind placebo controlled parallel group design in cooperation of the academic Adult~     ADHD-outpatient clinics of the Central Institute of Mental Health, Mannheim and the Institute~     of Legal and Traffic Medicine of the University of Heidelberg, Germany.~      It is expected that treatment with atomoxetine will improve practical driving abilities and~     driving related neuropsychological processing. It is expected that risk taking and impulsive~     decision making will be reduced and sustained attention and overview of complex traffic~     situations will be improved while driving.~   "
200469|NCT00938730|"~     The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150~     in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and~     tolerability data.~   "
200470|NCT00938717|"~     The purpose of this study is to determine the safety and efficacy of linaclotide administered~     to patients with Irritable Bowel Syndrome with Constipation (IBS-C).~   "
200472|NCT00938691|"~     Certain parts of the body, such as the chest, back, and shoulders, are notorious for~     producing cosmetically poor scars after cutaneous surgery. While very little research has~     been done to understand these poor outcomes, it is generally thought that increased tension~     across the skin inherent to these body areas leads to significant widening of the final scar.~     Historically, the only way to combat this tension was to support the deeper portion of the~     wound with sutures that dissolve over several weeks. However, scars take many months to fully~     develop their greatest strength. So even with the standard technique, wounds in areas of high~     tension still show spreading of the scar with time. The investigators believe that these~     wounds require an extended duration of support throughout the scar's maturation period. Until~     recently, there did not exist a suture that could provide this long duration of support~     without also carrying the risk of the body rejecting it. Recently, a new extremely long~     acting absorbable biomaterial has been FDA approved for use as a suture. The investigators~     plan to use this suture to test the theory that alleviating stress on high tension wounds~     throughout the period which they gain their maximal integrity produces less scar spread and~     ultimately better cosmetic outcomes.~   "
200473|NCT00938678|"~     This study compared the pharmacokinetics, pharmacodynamics and the safety of Pegfilgrastim~     Hospira and Neulasta® following a single dose of 6 mg of each product administered~     subcutaneously in Treatment Periods 1 and 2, respectively, in healthy volunteers.~   "
200474|NCT00938665|"~     The proposed study is designed to evaluate the performance of the COGNISION™ System as a tool~     to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings.~     The design of this study is guided by two overriding factors: 1) to optimize the performance~     of the event related potentials (ERP) classifiers, the subjects making up the training sets~     must be well characterized as to their clinical diagnosis, and 2) all ERP tests must be~     performed and reproduced in real-world clinical settings.~   "
200475|NCT00938652|"~     The goal of this study was to determine the effect on overall survival and progression free~     survival by adding iniparib (BSI-201/SAR240550) to the combination of gemcitabine/carboplatin~     in adult patients with triple negative breast cancer (estrogen receptor (ER)-negative,~     progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2~     (HER2)-negative).~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact~     mechanism has not yet been fully elucidated, however based on experiments on tumor cells~     performed in the laboratory, iniparib is a novel investigational anti-cancer agent that~     induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in~     the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging~     modalities in tumor cell lines. Investigations into potential targets of iniparib and its~     metabolites are ongoing.~   "
200476|NCT00938639|"~     The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for~     eliciting an immune response to H1N1 influenza in healthy adults.~   "
200477|NCT00938626|"~     RATIONALE: Giving chemotherapy followed by treated T cells before a stem cell transplant~     stops the growth of cancer cells by stopping them from dividing or by killing them. After~     treatment, stem cells are collected from the patient's blood and stored. High-dose~     chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells~     are then returned to the patient to replace the blood-forming cells that were destroyed by~     the chemotherapy.~      PURPOSE: This phase I trial is studying the side effects and best way to give treated T cells~     followed by stem cell transplant in treating patients with multiple myeloma.~   "
200478|NCT00938613|"~     The primary objective of this study was to compare the relative efficacy of Budesonide~     administered via Captisol-Enabled Budesonide nasal solution and Rhinocort Aqua in patients~     with seasonal allergic rhinitis (SAR) exposed to controlled ragweed pollen using an EEC~     model.~   "
200479|NCT00938600|"~     This is a preliminary study of oral vitamin D3 supplementation in pregnant and non-pregnant~     women of reproductive age in Bangladesh. The primary objective of the study is to identify a~     dose of vitamin D3 that can safely be administered during pregnancy to improve the vitamin D~     status of the mother and infant.~   "
200480|NCT00938587|"~     This study will investigate the safety and efficacy of an investigational drug, PF-04171327~     on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids~     while on background methotrexate. This study will also look at the response of chemical and~     biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK~     (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.~   "
200481|NCT00938574|"~     This is a phase I, prospective, open-label, single center, dose finding study with Atu027 (an~     siRNA formulation) given as single treatment followed by repeated treatment (repeated~     treatment phase: 8 treatments within 4 weeks) as therapy in subjects with advanced solid~     cancer.~   "
200482|NCT00938561|"~     Glomerular filtration rate (GFR) is widely accepted as the best index of kidney function in~     health and disease, and accurate values are required for optimal clinical decision making and~     in large-scale epidemiologic studies and clinical trials. Current recommended methods for~     measuring GFR are expensive, cumbersome to administer and assay and requires urine collection~     and administration of radioactive materials. The purpose of this study is to evaluate two~     non-radioactive markers (iohexol and gadolinium) compared to urinary clearance of inulin and~     iothalamate. The investigators hypothesize that plasma clearance of non-radioactive markers~     will be unbiased compared to a gold standard and more precise than currently used urinary~     clearance methods.~   "
200483|NCT00938548|"~     The investigators hypothesize that pregabalin will decrease post-operative pain scores and~     analgesic use following total mastectomy compared to placebo. The primary outcome will be~     acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total~     analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1~     week and 1 month after operation.~   "
200484|NCT00938535|"~     This study will evaluate the efficacy of a behavioral intervention, designed to prevent~     weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared~     to usual care.~   "
200485|NCT00938522|"~     The purpose of this study is to investigate the effect of cilostazol loading before planned~     PCI on major adverse cardiac and cerebrovascular events in patients with coronary artery~     disease.~   "
200489|NCT00938470|"~     This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine,~     fluorouracil, and radiation therapy works compared with fluorouracil when given together with~     oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or~     gastroesophageal junction that has spread from where it started to nearby tissue or lymph~     nodes. Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from dividing. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination~     chemotherapy) together with radiation therapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed.~   "
200490|NCT00938457|"~     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor~     and cause less damage to normal tissue.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic~     radiation therapy in treating patients with liver metastases.~   "
200491|NCT00938444|"~     This protocol is designed to evaluate the BRADA and ABILHAND questionnaires in rheumatoid~     arthritis (RA) patients that will be treated with an effective therapy. Patients with~     moderate to severe RA treated with tocilizumab will be asked to complete the BRADA and~     ABILHAND questionnaires at screening, baseline, after 12 weeks and after 24 weeks of~     treatment. All other assessments and questionnaires from daily clinical practice (such as the~     global assessment of disease activity by the patient, the Health Assessment Questionnaire~     (HAQ), the SF36 questionnaire, measurement of ESR and CRP and the DAS 28 calculation), will~     also be used to evaluate these questionnaires.~   "
200492|NCT00938431|"~     The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in~     children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to~     3 other antiepileptic drugs (AEDs).~   "
200493|NCT00938418|"~     Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and~     radiation. However, the cure rate is low.~      This study is carried out to find out whether giving radiotherapy at a higher dose over fewer~     treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment~     outcome.~      This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng~     Hospital over a period of about 2 years.~   "
200494|NCT00938405|"~     This is a prospective, randomized, double blind, parallel, placebo controlled clinical trial~     evaluating the efficacy of colesevelam HCl in reducing LDL in subjects with type 1 diabetes~     mellitus over a 12 week treatment period. The aim is to highlight the effect of colesevelam~     on LDL cholesterol and glycemia in a type 1 diabetic population. The colesevelam group is~     anticipated to demonstrate a mean reduction in LDL by 10% compared to the placebo group,~     indicated by A1c and glycemic target range CGM readings.~   "
200495|NCT00938392|"~     The objective of the study is to evaluate immunogenicity between different formulations of~     GSK Biologicals' investigational vaccine GSK2186877A.~   "
200496|NCT00938379|"~     Rural communities involved in agriculture are often at highest risk of insect-borne diseases~     in Southeast (SE) Asia.~      Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases~     for those people working outdoors in high risk areas.~      This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce~     incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to~     1000 households from 100 villages in rural Laos. In each house the investigators shall~     recruit up to 5 individuals. Half of households will be randomised to repellent, half to a~     placebo. All individuals will be provided with insecticide treated bed nets for use at night.~     All household occupants will be followed for 7 months to record malaria cases by Rapid~     Diagnostic Test every month. Blood spots will be collected at start and end of study to~     measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated.~     Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese~     Encephalitis (secondary outcomes).~   "
200497|NCT00938366|"~     The purpose of the study is to assess the influence of pantoprazole on the pharmacokinetic~     profile of cladribine, especially in terms of extent of absorption of cladribine since~     pH-modifying drug may potentially affect the stability of cladribine and thereby its~     bioavailability~   "
200498|NCT00938353|"~     Acute laryngotracheobronchitis, better known as croup, is one of the common respiratory~     complaints among children and the most common cause of airway obstruction in children aged~     six months to six years. Patients with croup are typically visited by physicians during two~     peak time periods throughout the year. The first one is in the autumn, usually as a result of~     parainfluenza virus, and the second peak occurs in early winter, a consequence of RSV. Croup~     affects males more commonly than females and affects children between the ages of 6 months to~     6 years. The incidence of croup peaks in children at 2 years of age; croup in older children~     is uncommon, and recurrent episodes are frequently observed.~      Croup symptoms are generally short-lived, with about 60% of children showing resolution of~     their barky cough within 48 h. However, a few children continue to have symptoms for up to 1~     week. Although most children with croup recover without specific treatment, up to 15% require~     hospital admission, and, among those admitted, up to 5% may require intubation.~      Nebulised adrenaline is effective but it has a short duration of action and potentially~     dangerous side effects, and it is therefore not recommended for use in the community in~     mild-moderate Croup.~      Oral and intramuscular steroid treatment, when given in adequate doses in hospital, has been~     shown to be effective for moderate to severe croup in a number of trials and a meta analysis.~      It has been suggested that nebulised administration is superior to the oral or intramuscular~     route of administration for a more rapid onset of action and fewer side-effects.~      This study is aimed to demonstrate the effectiveness of nebulised steroid administration as~     beclomethasone dipropionate in croup patients compare to placebo.~   "
200499|NCT00938340|"~     The purpose of this study is to evaluate the acute, postprandial effects and mechanism of~     action of various walnut components (separated nut skins, de-fatted nut meat, nut oil) versus~     whole walnuts on oxidative stress, inflammation and measures of platelet and endothelial~     function in healthy adults with moderately elevated cholesterol levels.~   "
200500|NCT00938327|"~     This post marketing surveillance will evaluate reactogenicity and safety data of human~     rotavirus vaccine when administered to healthy infants according to the Prescribing~     Information in India.~   "
200509|NCT00938210|"~     The standard procedure for treating colonic cancer is changing from open surgery to~     laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass~     and have a reduction in physical function, but the investigators do not know if this is also~     the case following laparoscopic surgery.~      This study examines how fatigue, quality of life, physical function, and body composition~     changes following laparoscopic colonic surgery.~      Patients are examined preoperatively and postoperative day 10 and 30.~   "
200510|NCT00938197|"~     To evaluate the pharmacokinetic drug interaction after oral concurrent administration of~     fimasartan and amlodipine in healthy male volunteers~   "
200511|NCT00938184|"~     The primary purpose of this study is to to assess the pharmacokinetics of paroxetine after~     single doses of paroxetine CR at the dose levels of 12.5, 25 and 50mg in healthy Japanese~     male volunteers.~   "
200512|NCT00938171|"~     The purpose of this study is to determine therapeutic benefits by local anesthetic technique~     for breast cancer.~   "
200513|NCT00938158|"~     The purpose of this study is to assess the pharmacokinetics and safety of a single~     subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with~     varying degrees of renal function, including subjects requiring hemodialysis.~   "
200514|NCT00938145|"~     RATIONALE: New diagnostic procedures, such as 3 Tesla magnetic resonance imaging (MRI), may~     help find bladder cancer and learn the extent of disease.~      PURPOSE: This clinical trial is studying how well 3 Tesla MRI works in finding cancer in~     patients with bladder cancer.~   "
200515|NCT00938132|"~     To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety~     of warfarin in healthy male volunteers.~   "
200516|NCT00938119|"~     This multicenter, prospective, observational registry will assess efficacy and safety~     outcomes associated with percutaneous coronary intervention (PCI) with implantation of the~     CYPHER Select™+ Sirolimus-eluting Coronary Stents in Chinese diabetic patients with coronary~     artery disease in routine clinical practice.~   "
200517|NCT00938106|"~     Patients with cervix cancer usually require external radiation given to the whole pelvis then~     an internal radiation boost, also called brachytherapy, to treat any remaining tumour.~     Standard brachytherapy has been used successfully for many years, but does not take into~     account differences in the shape of the tumour or normal structures between patients. This~     study aims to implement individualized -optimized- brachytherapy, based on international~     recommendations. MR scanning with the intra-uterine applicator in place allows improved~     identification of residual tumour and normal structures, allowing brachytherapy to be~     individualized for each patient with the aim to reduce side-effects and improve outcome.~     Additionally, repeating MR scans during brachytherapy treatment will allow further assessment~     on motion of the applicator during treatment and the effect on radiation dose. Sexual health~     assessments aim to identify the relationship between sexual health and treatment effects.~   "
200518|NCT00938093|"~     The research study proposed is designed to examine the outcomes of a cognitive behavioral~     guided self-care intervention with older adults diagnosed with generalized anxiety disorder~     and recruited from a primary care setting. It is hypothesized that the cognitive behavioral~     guided self-care intervention will produce greater declines in worry and anxiety than~     enhanced usual care.~   "
200519|NCT00938080|"~     The purpose of this study is to assess the safety and tolerability of AG013 (genetically~     modified L. lactis bacteria engineered to secrete human Trefoil Factor 1), and to explore the~     ability of AG013 to attenuate the course and severity of oral mucositis (OM) in subjects~     receiving induction chemotherapy for the treatment of head and neck cancer.~   "
200520|NCT00938067|"~     The purpose of this study is to provide American Indian trauma patients, treated at the~     Harborview Level 1 urban trauma center, compassionate and culturally sensitive care and to~     link them to care in their distant tribal communities. The specific aims include 1) interview~     Native healers to gather information on culture-specific aspects of recovery from traumatic~     injury and on linking care to tribal communities, 2) conduct a randomized controlled trial to~     evaluate the implementation and effectiveness of the intervention. The investigators~     hypothesize that intervention patients will demonstrate greater improvement than controls in~     post-traumatic stress disorder (PTSD) symptoms, depression, functioning, diagnoses, and fewer~     new injuries during the 6 months after the index injury.~   "
200521|NCT00938054|"~     Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery~     is considered rare. Reports by Lovaas and McEachin, Smith & Lovaas and more recently by~     Cohen, Amerine-Dickens, & Smith, Smith Groen et al. and Sutera Pandey et al suggest that~     intensive behavioral intervention programs during preschool years may result in improvement~     to the point where some children no longer meet criteria for autism by the time they reach~     school age. Similarly, there are a large number of anecdotal reports of children with autism~     who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin~     supplements, chelation), are indistinguishable from their typically developing peers. The~     goal of the current research is to characterize the behavioral and biological profiles of~     children with autism who show significant symptom reduction such that they no longer meet~     criteria for autism (Remitted Autism [REM-AUT]) and to contrast them with a group of children~     who continue to meet criteria for autism (AUT) and to typically developing (TD) group of~     children. Examining whether neurobiological and neurobehavioral symptoms commonly reported in~     autism are as frequent and severe in children who have responded to treatment is an important~     first step in determining what factors may contribute to symptom remission in autism. In~     addition, understanding how children with remitted autism compare to typically developing~     children will help us better understand whether symptom improvement is through remediation~     (normalization of function) or compensation (achieving the same behavioral/adaptive outcome~     but through an alternative process).~   "
200535|NCT00937872|"~     The primary objective of this study is to determine the absolute bioavailability of SRT2104~     as a 250 mg suspension, and to define the intravenous pharmacokinetics of SRT2104.~      The secondary objective of this study is to assess the potential systemic metabolite burden~     of SRT2104, and to provide plasma and urine samples for subsequent metabolite profiling and~     identification.~   "
200536|NCT00937859|"~     The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that~     SER120 will decrease the number of nocturic episodes compared to placebo.~   "
200522|NCT00938041|"~     This multicenter study will determine the response rate, the complete response rate, duration~     of response, time to progression, time-to-treatment failure, safety, and survival following~     treatment with Iodine-131 Anti-B1 Antibody for the retreatment of patients with non-Hodgkin's~     lymphoma who previously responded with a duration of response of at least 3 months to~     Iodine-131 Anti-B1 Antibody therapy. Patients will undergo two phases of study. In the first~     phase, patients will receive a dosimetric dose of unlabeled Anti-B1 Antibody (450 mg)~     followed by Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131.~     Whole body gamma camera scans will be obtained after the dosimetric dose and data from three~     imaging time points will be used to calculate a patient-specific dose to deliver the desired~     total body dose of radiotherapy. In the second phase, patients will receive the therapeutic~     dose of unlabeled Anti-B1 Antibody (450 mg) followed by 35 mg of Anti-B1 Antibody labeled~     with the patient-specific dose to deliver the desired whole body dose of radiation. Patients~     will be treated with thyroid blocking medication at least 24 hours prior to the first~     infusion and continuing for 14 days following the last infusion.~   "
200523|NCT00938028|"~     The purpose of this study is to evaluate the effects of storage and handling on fecal samples~     collected for metabolomic, proteomic and microbiomic and analysis.~   "
200524|NCT00938015|"~     The aim of this study is to evaluate if the data obtained in controlled clinical trials are~     confirmed when Enbrel is used in usual clinical practice in Belgium according to local~     reimbursement criteria.~   "
200525|NCT00938002|"~     Critically ill patients on a breathing machine are at risk of developing a type of pneumonia~     called Ventilator Acquired Pneumonia (VAP). The purpose of this study is to determine if~     regular lung rinses sent for microbiological testing can reduce the time to diagnose VAP. The~     study also plans to test the accuracy and speed of a new technology, using multiplexed~     automated digital microscopy, to identify the germs causing the VAP.~   "
200526|NCT00937989|"~     RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help~     doctors learn more about improving the treatment process and improve patients' quality of~     life.~      PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for~     patients with breast cancer.~   "
200527|NCT00937976|"~     The primary objective is to test the hypothesis that periodontal intervention in dialysis~     patients who have both periodontal disease and a historically high burden of cardiovascular~     disease will result in a reduction of inflammatory markers and improvement markers of~     nutrition health like albumin. Patients will be randomized to one of two treatment arms:~     intensive periodontal therapy or control-delayed periodontal therapy. Eligible patients will~     have 5 study visits over 7 to 12 months.~   "
200528|NCT00937963|"~     Diacylglycerol (DAG) is a molecule that consists of two fatty acid chains bound by ester~     links to a glycerol molecule, in the form of 1,2 and 1,3 structural isomers. Approximately~     10% of the edible oils on today's market are comprised from DAG. DAG oil has a similar taste,~     appearance, and fatty acid composition as conventional triacylglycerol oil (TAG; consists of~     3 fatty acids chains bound to a glycerol molecule), yet recent studies suggest that due to~     its different chemical structure, DAG oil may induce cardiovascular (CV) benefits.~     Specifically, human studies in the United States (US) and Japan have shown that long-term~     consumption of a diet containing DAG oil enhances loss of body weight and body fat compared~     with TAG oil of similar fatty acid composition. In postprandial studies, serum triglycerides~     (TG) and remnant like particle cholesterol concentrations, have shown to be lower following~     ingestion of DAG-enriched oil compared to conventional dietary oil (e.g., soybean, corn), or~     TAG oil. Therefore, DAG oil appears to be effective for preventing postprandial~     hyperlipidemia, which is a risk factor for arteriosclerosis.~      The hypothesis that the investigators propose in this pilot study is that intake of DAG oil,~     compared to TAG oil will result in a lower LDL-C, and lower LDL-C/HDL-C ratio, as well as a~     reduction in TG levels. Given the significance of such findings, if confirmed, the~     investigators will evaluate other important clinical biomarkers for chronic disease (CV~     Disease, type 2 diabetes, metabolic syndrome), such as insulin sensitivity and inflammation~     [as determined by C-reactive protein (CRP), interleukin (IL)-1, IL-6 & tumor necrosis~     factor-alpha (TNF-α)], which also may be beneficially affected by consumption of the palm DAG~     oil. During the pilot study, the investigators will reserve serum/plasma samples so that~     these additional assays may be run upon approval of the modification.~   "
200529|NCT00937950|"~     This study is designed provide up to four years of annual oncogenic HPV DNA testing and~     cervical cytology examination for NCT 00122681 study subjects who displayed normal cervical~     cytology but tested positive for oncogenic HPV infection at their last NCT 00122681 study~     visit (Visit 10, Month 48).~      This follow-up study will also be offered to subjects who were pregnant at their last NCT~     00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at~     that visit.~      The objectives & outcome measures of the primary phase (study 008/580299) are presented in a~     separate protocol posting (NCT00122681).~   "
200530|NCT00937937|"~     This phase II trial is studying the side effects and how well dinaciclib works in treating~     patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
200531|NCT00937924|"~     The purpose of this study is to compare meperidine/midazolam with diphenhydramine,~     meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation~     methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine~     and promethazine) will improve sedation.~   "
200532|NCT00937911|"~     The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of~     venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower~     extremities.~   "
200533|NCT00937898|"~     The study is designed to assess the effects of a heart-healthy diet that includes lean beef~     as the primary source of high quality protein on risk factors for cardiovascular disease.~   "
200534|NCT00937885|"~     Reminiscence is the systematic use of memories and recollections to strengthen self-identity~     and self-worth. The study aim was to investigate the consequences for nursing home residents~     and staff of integrating reminiscence into daily nursing care. Ten nursing homes were~     randomised into either an Intervention Group, who implemented reminiscence, or a Control~     Group, who continued with usual care. Data were collected at baseline and again 6 and 12~     months after the intervention start. Results suggested that use of reminiscence can improve~     residents' quality of life and possibly delay progression in dementia symptoms. Nursing staff~     can experience greater satisfaction with personal and professional roles and develop a more~     positive view of the residents.~   "
200537|NCT00937846|"~     GSK1034702 is being developed for improving cognitive impairment in diseases such as~     Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate~     how much of the study drug gets into the brain. This will be done using Positron Emission~     Tomography (PET).~   "
200540|NCT00937807|"~     The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents~     (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid~     endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100~     % v/v) allows to obtain per-operating hemodynamic stability non inferior than with~     sevoflurane.~   "
200541|NCT00937794|"~     This study is being conducted to identify pediatric patients with Hunter syndrome who have~     neurodevelopmental disease characteristics, who are currently receiving treatment with~     Elaprase, and who may be suitable to participate in a clinical study with an investigational~     agent.~   "
200542|NCT00937781|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at tumor tissue samples from patients with melanoma~     treated on clinical trial EST-1690.~   "
200543|NCT00937768|"~     This randomized phase II trial studies the side effects and how well giving leuprolide~     acetate or goserelin acetate works compared to observation in treating patients with~     high-risk prostate cancer who have undergone radical prostatectomy. Androgens can cause the~     growth of prostate cancer cells. Antihormone therapy, such as goserelin acetate and~     leuprolide acetate, may lessen the amount of androgens made by the body and thus control~     prostate cancer growth. Many times, after surgery, the tumor may not need more treatment~     until it progresses. In this case, observation may be sufficient. However, in some prostate~     cancers there is a chance that tumors can re-grow despite surgery based on certain high risk~     features.~   "
200544|NCT00937755|"~     Schizophrenia is one of the most severe mental illnesses. The antipsychotic drugs, introduced~     in early 1950s, have revolutionized the treatment of schizophrenia. About 2 to 4 times as~     many patients relapse when treated with a placebo as do those treated with antipsychotic~     drugs. For these medications to be maximally beneficial, they must have an acceptable side~     effect profile and be taken as prescribed. One untoward effect of many antipsychotic drugs is~     weight gain. The extent of weight gain apparently varies by drug, which may be because of~     drugs'differing degrees of action on serotonergic, dopaminergic, histaminergic, and other~     neurotransmitter systems. Obesity is a threat to health and longevity. Weight gain may also~     cause patients taking antipsychotic medication to discontinue their medication, which may~     predispose them to relapse.~      The pattern of weight gain and metabolic disturbance may vary between the different~     antipsychotic agents. The underlying mechanism and treatment of these adverse metabolic~     effects remain unclear. This study will recruit 60 schizophrenic patients during. The~     patients received monotherapy with atypical antipsychotics (olanzapine, quetiapine, or~     risperidone). The assessment of metabolic profile will be monitored at baseline, week 2, week~     4, and week 8. The measurements include anthropometrical parameters, body composition,~     glucose level, insulin level, lipid profile, and leptin level. Intra-venous glucose tolerance~     test will be used to assess the insulin secretion and insulin sensitivity.~      This proposal broadly aims to discover the underlying mechanism of antipsychotics induced~     metabolic disturbance and develop efficient treatment to correct it.~   "
200545|NCT00937742|"~     The primary working hypothesis is that consuming processed tomatoes frequently/daily will~     favorably improve endothelium and platelet function disease-risk biomarker profiles in adult~     men and women compared to consuming no or relatively low amounts of processed tomatoes.~   "
200546|NCT00937729|"~     In case of lack of compliance in HIV1 patients, the investigators hope to prove that~     enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic~     education may contribute to obtain a good compliance more than 95% in these patients.~   "
200547|NCT00937716|"~     The overarching goal is to identify imaging markers that will predict treatment response, and~     to confirm or validate these biomarkers using anatomical studies of postmortem tissue. Early~     detection of drug response would yield specific treatment strategies that are tailored to the~     individual, thus improving both the quality of life of the patients and drastically reducing~     the costs associated with unsuccessful treatment strategies.~   "
200548|NCT00937703|"~     TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of~     the study is to show that during the initiation of a basal insulin treatment , a computerized~     decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks~     to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at~     the end of 4 mouths as compared with conventional care.~      Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a~     telemonitoring system compared to the reference group at 4 months.~   "
200549|NCT00937690|"~     Design: this is a pilot study of infrared imaging of cutaneous lesions in patients and~     volunteers with and without clinically detectable melanoma, and with one or more palpable~     cutaneous lesions eligible for this imaging study. Participants will be evaluated with~     infrared camera imaging at cutaneous sites with known melanoma deposits, suspected melanoma~     deposits that are to be biopsied, or at cutaneous sites with other lesions, including other~     skin cancers, benign inflammatory lesions, benign neoplastic lesions (lipomas, epidermal~     cysts, dermatofibromas, scar, healing wound, etc.).~   "
200550|NCT00937677|"~     The primary objective of this study is to define the effect of Tysabri in patients with~     relapsing-remitting (RR) multiple sclerosis (MS) over 2 years. The investigators will also~     explore the extent of remyelination in MS patients treated with Tysabri over 2 years.~      A secondary objective of this study is to investigate differences in the capacity for~     remyelination between patients who do or do not respond to Tysabri monotherapy during the~     same 24 months.~      A tertiary objective of this study is to monitor Tysabri effect in MS antiphospholipid~     antibodies positive and MS antiphospholipid antibodies negative patients and to determine~     perfusion differences according to the antiphospholipid antibodies positivity status.~   "
200551|NCT00937664|"~     The primary purpose of this study is to find out what the maximum tolerated dose is for an~     experimental drug called AZD7762 when given with the approved drug gemcitabine based on the~     side effects experienced by patients that receive both drugs.~   "
200710|NCT00935571|"~     The purpose of this study is to evaluate the incidence of postthoracotomy pain between total~     intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.~   "
244904|NCT00348335|"~     The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective~     in the treatment of ocular rosacea~   "
200552|NCT00937651|"~     Study objective:~        1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the~          oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential~          hypertension.~        2. To review the pharmacokinetic profile after the multiple administration and the~          pharmacodynamic profile regarding the renin-angiotensin system, after the oral~          administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential~          hypertension.~        3. To determine the dose for the clinical study at the next phase by analyzing the~          relationship between the antihypertensive efficacy and pharmacokinetic • pharmacodynamic~          results.~   "
200553|NCT00937638|"~     The proposed research will provide important information about the role of 2 intervention~     diets that provide different amounts of lean beef and meet current nutrient recommendations~     for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing~     in prevalence at alarming rates. The experimental and diet designs will enable us to evaluate~     lifestyle interventions for MetSyn for persons who maintain weight, lose weight and maintain~     their weight loss, as is currently recommended in clinical practice. Importantly, the~     investigators will compare a diet high in lean beef (5 oz/day) which is compositionally~     similar (i.e., energy and nutrients) to the modified-DASH diet, a low beef diet which has~     become the Gold Standard for the management of cardiovascular disease (CVD) risk factors,~     including MetSyn. In addition, the investigators also will evaluate a moderate-high protein~     diet (BOLD+) that is higher in total protein (from mixed sources including lean beef,~     7oz/day) than the BOLD diet, on CVD risk factors in persons with MetSyn. A follow-up study~     was conducted to assess dietary compliance in a sub-sample of the population at 12-months;~     participants were not informed of this end-point and additional consent was obtained.~      Hypotheses:~        1. Healthful isocaloric diets that include lean beef as the primary source of protein (BOLD~          diet) with average (18%; BOLD) or moderate-high (28%; BOLD+) total protein intake will~          show similar or greater reductions in CVD risk, respectively when compared to a~          modified-DASH diet.~        2. A healthful weight-loss diet, including lean beef as the primary source of protein in a~          high-moderate protein diet (BOLD+ diet), plus regular exercise (BOLD+ + ex) will reduce~          body weight equal to that of a BOLD + ex and DASH + ex intervention, but may improve CV~          risk factors (such as BP and TG), and therefore reduce the prevalence of MetSyn more~          than a BOLD + ex and DASH + ex intervention.~        3. The BOLD diet will be more effective than the modified-DASH diet, and the BOLD+ diet~          more effective than the BOLD diet in maintaining the CVD benefits attained during phases~          1 and 2. Dietary adherence will be better on the BOLD and BOLD + diets compared with the~          modified DASH diet.~   "
200554|NCT00937625|"~     The aim of this study is to investigate the toxicity and clinical response of therapy with~     tumor infiltrating lymphocytes as treatment for advanced melanoma.~      Patient will receive a single treatment consisting of conditioning chemotherapy for seven~     days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of~     high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with~     daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and~     immune response.~      After the first 6 patients the treatment with IL-2 has been changed to include higher doses~     of IL-2 (see intervention)~   "
200555|NCT00937612|"~     The purpose of this study is to determine the treatment outcome of postoperative concurrent~     chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.~   "
200556|NCT00937599|"~     The purpose this research is to check if Brazil Nuts consumed improvement the metabolic~     profile, state redox and endothelial function in obese adolescents.~   "
200557|NCT00937586|"~     The overall purpose of this research is to determine if certain genes increase the chance of~     developing prostate cancer and once diagnosed increase the chance of the prostate cancer~     spreading to other parts of the body.~   "
200558|NCT00937573|"~     The effectiveness, safety, and deliverability of second generation drug eluting stents (DES),~     including Xience V, will need to be examined in real world patients to provide the same level~     of evidence base and comfort that has accompanied the use of the first generation devices.~     Randomized clinical trials provide the fairest evaluation of outcomes by controlling for~     confounding patient and procedural characteristics; however, randomized clinical trials also~     exclude the very high risk patients that account for upwards of 80% of real world patient~     populations such as those at Wake Forest University Baptist Medical Center (WFUBMC).~      Clinical follow-up data including non-fatal MI, all cause mortality and stent thrombosis, as~     well as medications compliance, of patients undergoing stent therapy including Xience V in a~     real world patient population will be collected at WFUBMC. Existing data for several control~     groups will be used to compare outcomes with Xience V including a consecutively treated bare~     metal stent (BMS) cohort of 1,200 patients, and a DES cohort of 1,200 patients (900~     sirolimus-eluting and 300 paclitaxel-eluting) treated between April 2004 and April 2005.~     Patients undergoing stent therapy in the year prior to use of Xience V, and contemporaneous~     patients receiving non-Xience V stent therapy during Xience V use will serve as additional~     controls. All patient data will be de-identified using unique blinded identification codes~     after data collection is completed.~      The null hypothesis of this study states that safety outcomes (stent thrombosis, non-fatal~     MI, death) with Xience V will be equivalent to historical and contemporaneous controls;~     effectiveness outcomes (target lesion and target vessel revascularization) with Xience V will~     be superior to historical and contemporaneous BMS controls, and equivalent to historical and~     contemporaneous DES controls; and the need for crossover to another stent type will be equal~     to that observed with historical DES controls. Outcomes will be reported using contemporary~     measures of clinical outcomes and analyzed using Cox proportional hazards survival analysis~     methodology. These data should provide important information on the clinical effectiveness~     and safety of Xience V in routine practice.~   "
200559|NCT00937560|"~     This single arm study evaluated the efficacy and safety of first-line chemotherapy with~     carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with~     epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8~     3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each~     cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an~     area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy,~     bevacizumab could be continued to be given as a monotherapy.~   "
200560|NCT00937547|"~     1. Hypothesis:~           If high risk genotypes of human papillomavirus (HPV) is the cause of cervical cancer~          worldwide, the genotypes associated with cervical cancer in Venezuela would be the same~          types found in other countries.~        2. Objectives:~      Primary objective:~      The objective of this investigation is to determine the presence and genotypes of HVP~     infection in cervical intraepithelial neoplasia grade 2/3 (CIN 2/3), and Stage I cervical~     epidermoid carcinoma and cervical adenocarcinoma.~      Specific objectives:~      To establish the presence of HPV in cervical cancer patients in Venezuela by geographic~     distribution.~      To establish which HPV types are linked with cervical cancer in Venezuela by geographic~     distribution.~   "
200561|NCT00937534|"~     The purpose of this study is to compare and assess the safety and pharmacokinetic~     characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and~     young male volunteers.~   "
200562|NCT00937521|"~     This study is aimed at assessing the safety and immunogenicity of different doses and~     formulations of a new Novartis Meningococcal B Recombinant Vaccine.~   "
200620|NCT00936754|"~     The primary endpoint of this trial will be to evaluate the safety of a single administration~     in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a~     test meal. The secondary endpoint of this trial will be to evaluate if a single~     administration in human of a dose of 500 mg of a polyphenol-rich algal powder is able to~     reduce the rate of carbohydrate absorption as measured by following postprandial glycemia and~     insulinemia.~   "
200563|NCT00937508|"~     This study is a randomized, double-blind, placebo-controlled clinical trial which evaluates~     the efficacy of preoperative smoking counseling and varenicline (a medication approved by~     Health Canada and FDA for quitting smoking) to provide long term smoking cessation (i.e.,~     abstinence for at least one year) in surgical patients.~      The primary hypothesis is as follows: A significant percentage of surgical patients will be~     receptive to smoking cessation interventions in the pre-admission clinic and will refrain~     from smoking at 24 and 52 weeks after starting the treatment. The secondary hypothesis is as~     follows: Patients who receive interventions but do not quit smoking will have reduced number~     of cigarettes consumed/day or improved their readiness to quit smoking at 24 and 52 weeks~     after starting the treatment.~   "
200564|NCT00937495|"~     This phase II trial is studying how well giving vorinostat together with bortezomib works in~     treating patients with advanced soft tissue sarcoma. Vorinostat and bortezomib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     vorinostat together with bortezomib may kill more tumor cells.~   "
200565|NCT00937482|"~     This phase I trial is studying the side effects and best dose of cediranib maleate when given~     together with whole brain radiation therapy in treating patients with brain metastases from~     non-small cell lung cancer. Cediranib maleate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Radiation~     therapy uses high-energy x-rays and other types of radiation to kill cancer cells and shrink~     tumors. Giving cediranib maleate together with radiation therapy may kill more tumor cells~   "
200566|NCT00937469|"~     The primary purpose of the trial is to examine the effect of the combination of social skills~     training, parental training and standard treatment versus standard treatment in ADHD~     patients.~      The secondary purpose is to examine differences in the effect of the treatment in relation to~     the different competences of attachment: secure attachment: unsecure dismissing, unsecure~     preoccupied or disorganized attachment and in the categories; emotional openness, balance of~     positivity / negativity to attachment figure/s, idealisation of attachment figure/s,~     dismissal and/or derogation of attachment, the ability of conflict resolution,~     disorganisation and coherence of the narrative description.~      The tertiary purpose of the trial is to examine differences in the effect of the treatment in~     relation to the degree of parents symptoms of ADHD.~   "
200567|NCT00937456|"~     To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in~     Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.~   "
200568|NCT00937443|"~     The incidence of heart failure grows as the population continues to age. Heart failure~     incidence approaches 10 per 1,000 persons after the age of 65. Although pharmacotherapy~     improves the treatment of heart failure it remains insufficient in preventing the progression~     of this debilitating disease. Cell based therapy has gained great strides over the last~     decade, launching cellular therapy into the mix of artillery for the treatment of chronic~     heart failure and coronary disease. While early pre-clinical work demonstrates that stem cell~     based therapy improves heart failure the exact mechanism in which these endothelial~     progenitor cells (EPC's) are recruited from the bone marrow, proliferate under the mediation~     of growth factors, and migrate to the injured tissues endogenously still remains obscured.~     Therefore in order for clinicians and scientist to impact heart failure treatment, a greater~     understanding of the physiological changes in EPC's and other modulators of cardioreparative~     process need further investigation.~   "
200569|NCT00937430|"~     The purpose of this study is to find out if performing a bowel preparation prior to pelvic~     organ prolapse surgery has any effect on the return of bowel function after surgery.~   "
200570|NCT00937417|"~     RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as docetaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving vandetanib together with~     docetaxel may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib given~     together with docetaxel in treating patients with advanced solid tumors.~   "
200571|NCT00937404|"~     The study will evaluate the safety and reactogenicity of PoliorixTM given as primary~     vaccination course to Chinese children at 2, 3 and 4 months of age.~   "
200572|NCT00937391|"~     The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist~     in children 2 months to < 2 years of age~   "
200573|NCT00937378|"~     The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that~     SER120 will decrease the number of nocturic episodes compared to placebo.~   "
200574|NCT00937365|"~     This study compares three treatments for low back pain that started during pregnancy. The~     study hypothesizes that exercise, spinal manipulation, and a mind-body technique called~     neuroemotional technique (NET) equally affect pain intensity and disability associated with~     pregnancy-related low back pain. The study also hypothesizes that pain intensity and~     disability levels do not influence maternal heart rate variability (a measure of stress) and~     intrauterine attachment (a measure of relationship quality). Ten women will additionally~     provide blood and salivary oxytocin samples during pregnancy and periodically for three~     months after birth. These women and their babies will also be videotaped playing for 5~     minutes at 2 weeks, 6 weeks, and 3 months postpartum.~   "
200575|NCT00937352|"~     The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab~     (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study~     ELN115727-301 or study ELN115727-302.~   "
200621|NCT00936741|"~     Participants in study C-1073-400 (NCT00569582) will be invited to participate in this~     extension study to examine the long term safety of mifepristone in the treatment of the signs~     and symptoms of endogenous Cushing's syndrome. Total treatment duration may be up to 12~     months or longer at the discretion of the Investigator.~   "
200622|NCT00936728|"~     RATIONALE: It is not yet know whether white wine is more effective than a nutritional~     supplement in improving appetite.~      PURPOSE: This randomized clinical trial is studying white wine to see how well it works~     compared with a nutritional supplement in improving appetite in patients with cancer~   "
200623|NCT00936715|"~     The objective of this study is to provide open label emtricitabine/tenofovir disoproxil~     fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study~     GS-US-203-0107.~   "
200576|NCT00937339|"~     The overall aim of the proposed study is to determine whether whole body vibration is~     beneficial in promoting bone health, physical fitness and neuromotor performance in patients~     with chronic stroke.~      Subjects in the experimental group will undergo whole body vibration therapy (1 session per~     day, 3 sessions per week) for 8 weeks. The vibration frequency used in this study will be~     30Hz. The total duration of exposure to vibration for the experimental group will be 10~     minutes. While standing on the vibration platform, patients will be instructed to repeat the~     following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side~     weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the~     spot. The control exercise group, on the other hand, will perform the same exercise program~     on the platform, but no vibration will be given. The training will be conducted by a~     qualified personnel with physiotherapy background.~      The outcome measurement will be performed 4 times: (1) immediately before the commencement of~     intervention, (2) immediately after termination of treatment, (3) at 1 month after~     termination of treatment. Each subject will be evaluated for bone markers, leg muscle~     strength, balance, spasticity, and walking ability.~   "
200577|NCT00937326|"~     The primary purpose of this study is to determine the safety and tolerability of SRT2104~     (0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for~     28 consecutive days, and to characterize the pharmacokinetic profile of SRT2104 after a~     single dose and multiple administrations in type 2 diabetic subjects.~      The secondary purpose of this study is to determine the effect of SRT2104 (0.25, 0.5, 1.0,~     and 2.0 g/day) when administered once daily for 28 consecutive days on fasting blood glucose~     and insulin and post-prandial blood glucose and insulin in type 2 diabetic subjects.~   "
200578|NCT00937313|"~     -  To assess whether acute, moderate Champagne wine consumption modulates endothelial~          function in healthy human volunteers.~        -  To establish the bioavailability of Champagne wine polyphenols and their metabolism.~   "
200579|NCT00937300|"~     The aim of this study is to investigate the toxicity and immune response of therapy with~     tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary~     operation and radiotherapy.~      Patient will receive a single treatment consisting of conditioning chemotherapy for seven~     days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of~     high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with~     daily low-dose interleukine-2. Patients will be evaluated for toxicity and immune response.~   "
200580|NCT00937287|"~     African American women living in the rural South are twice as likely as Caucasian women to~     develop cervical cancer and die of invasive cervical cancer at a higher rate than any other~     racial/ethnic group in the US (1). Reasons for low HPV vaccination rates among rural African~     Americans are not well understood. HPV vaccination compliance is likely influenced by~     barriers to health care access, misinformation regarding vaccinations, religious beliefs~     related to sexual health and behaviors, and mistrust of the medical community (2, 3). Because~     the vaccination of minors requires primary caregiver consent, vaccination commitment and~     compliance is strongly influenced by family beliefs and communication regarding health and~     sexuality. To date, little research has examined the cultural, familial, and intrapersonal~     influences on HPV vaccination compliance among rural African American women. This study will~     address these gaps in the literature and provide data needed to develop effective~     interventions and health promotion materials to encourage HPV vaccination among rural African~     American women.~      From a pool of approximately 800 families who are participating in ongoing longitudinal~     research through the Center for Family Research at the University of Georgia, the~     investigators will recruit 200 rural female African American youth aged 13-17 who have not~     received the HPV vaccine and their primary caregivers (n=200) into an observational,~     prospective study on vaccination commitment and compliance. The investigators hypotheses are~     as follows:~        1. Sociocultural factors that rural African Americans experience, including discrimination,~          previous health care experience, religious beliefs, and community norms regarding HPV~          vaccination and adolescent sexual behavior, will forecast primary caregivers' HPV~          vaccination commitment and compliance for their daughters. The investigators also~          predict that primary caregivers' HPV-related knowledge and attitudes will mediate this~          association.~        2. Sociocultural factors will influence sexual health-related family communication and~          interaction, primary caregivers' and youths' HPV-related attitudes, and HPV vaccination~          commitment and compliance.~        3. Primary caregivers' attitudes, youths' attitudes, and family health communication will~          contribute to youths' and caregivers' vaccination commitment and compliance.~        4. Youths' sexual behavior will influence their attitudes, family health communication, and~          vaccination commitment and compliance.~   "
200581|NCT00937274|"~     This study hopes to demonstrate the potentials of a new form of therapy for childhood~     diarrhea, a major cause of morbidity and deaths in Bangladesh and other developing countries,~     and thus a priority for improving child health.~   "
200582|NCT00937261|"~     The purpose of this study is to better understand brain function and psychiatric and~     neurological illness when taking Invega or Risperdal. The objective is to compare the brain~     effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be~     evaluated with PET imaging, fMRI, and neurological ratings and assessments.~   "
200583|NCT00937248|"~     This study is designed to investigate whether or not the use of a customized vacuum~     immobilization device (CVID) to immobilize rectal cancer patients undergoing preoperative~     pelvic radiation therapy improves the positional stability of patients during each radiation~     treatment. This question is more relevant now in the era of image-guided radiation therapy~     (IGRT). Using state of the art IGRT technologies such as cone beam CT (CBCT) scanning,~     assessments of the accuracy of treatment delivery can be made during a course of radiation~     therapy allowing for patient set-up corrective strategies to be implemented. The use of CBCT~     scanning may minimize any potential benefit of of a CVID if the patient's pretreatment~     position can be corrected prior to treatment and our current immobilization strategy results~     in a stable patient position. While it is seemingly intuitive to assume that the use of CVID~     results in better patient stability, there is actually little data to support this.~   "
200584|NCT00937235|"~     This study will examine the effect of combining prolonged exposure, a cognitive-behavioral~     treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and~     counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month~     treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged~     exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the~     end of treatment and 6-month follow-up.~      We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease~     in cigarettes smoked will be greater among participants who receive the combined treatment~     for both PTSD and smoking.~   "
200624|NCT00936702|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel~     and everolimus works in treating patients with previously untreated cancer of unknown~     primary.~   "
201776|NCT00921336|"~     This study will determine the maximum dose of KW-2450 that can be administered safely to~     subjects with advanced previously treated solid tumor and evaluate its effectiveness.~   "
200585|NCT00937222|"~     Peanuts and peanut butter contain high levels of monounsaturated fat (MUFA), arginine, fiber,~     phytosterols, resveratrol and vitamin E that have the potential to reduce cardiovascular~     disease (CVD) risk through improved blood glucose control and favorable modification of blood~     lipids. When substituted for saturated fat in the diet, MUFA may have important metabolic~     benefits for persons with diabetes. Therefore, the investigators propose to study the effects~     of a peanut and peanut butter-enriched diet on markers of CVD risk factors in free-living~     adults with diabetes residing in Southern California. This study's primary clinical outcome~     will be high-density lipoprotein (HDL) - cholesterol. Secondary outcomes will include~     additional serum lipids (total cholesterol, low-density lipoprotein (LDL) - cholesterol and~     triacylglycerol), glucose, HbA1c, and anthropometry (body weight, body composition and waist~     circumference). This study will provide vital information about the role of peanuts and~     peanut butter in modulating blood glucose homeostasis and CVD risk factors among adults with~     diabetes.~   "
200586|NCT00937196|"~     The objective of the present study was to examine the effects of a single placebo~     intervention on blood pressure and to investigate autonomic and psychological mediating~     mechanisms.~   "
200587|NCT00937183|"~     RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's~     cancer cells, may stimulate the immune system in different ways and stop cancer cells from~     growing.~      PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to~     see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma.~   "
200588|NCT00937170|"~     The purpose of this study is to compare results obtained with gender-specific and traditional~     knee replacement systems design among women undergoing total knee replacement surgery. Women~     who qualify and agree to participate will be randomly assigned to receive either a~     traditional or gender-specific knee replacement. During surgery, measurements of bone~     resection and bone-to-implant relationships will be recorded. At selected time intervals,~     participants will be asked to fill out questionnaires regarding pain and function, will be~     examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a~     subset of participants will be randomly selected to undergo gait analysis to evaluate knee~     motion and muscle function.~   "
200589|NCT00937157|"~     This study will:~        -  Explore whether GA decreases inflammation more on the 3T optimized protocol when~          compared to the 1.5T standard protocol.~             -  Compare whether the decrease in the cumulative number of Gd-enhancing lesions~               significantly differs between pre-treatment (day 0) and post-treatment (12 months)~               using 1.5T standard and 3T optimized protocols.~        -  Investigate the correlation between MTR and the cumulative number and volume of Gd~          enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with~          GA.~      This study suggests that GA may favorably affect early events in lesion formation, in~     addition to exerting more transient beneficial effects on established areas of inflammation~     and demyelination, and that this effect may be observed only with the 3T optimized protocol.~   "
200590|NCT00937144|"~     The investigators would like to study the endothelial function in sickle cell patients~     without pulmonary hypertension in an in vivo method during a steady state condition before~     and after sildenafil treatment for 1 month, and to study the effects of this nitric oxide~     donor by measuring the Flow Mediated Dilatation, by measuring endothelial progenitor stem~     cells colonies, and by measuring the effect of therapy on markers of inflammation (cell~     adhesion molecules and cytokines).~   "
200591|NCT00937131|"~     TTP is a rare and serious blood disorder, characterized by the formation of small clots~     (micro thrombi) within the circulation and can be fatal. The formation of blood clots occurs~     primarily in the smaller blood vessels, the arterioles and capillaries, associated with~     multisystem organ involvement, especially the brain and kidneys. TTP has an incidence of~     approximately 1-3 people/million of the population/year.~      TTP is due to a decrease in an enzyme, ADAMTS 13 that is released by cells lining blood~     vessels (endothelial cells). ADAMTS 13 'cleaves' or breaks down very large von Willebrand~     Factor (vWF) strands. vWF is used in blood clotting. Deficiency or inhibition of the enzyme,~     results in release of the ultra large vWF into the circulation. Platelets bind to these ultra~     large vWF multimers, promoting blood clot formation and platelet consumption~     (thrombocytopenia). In more then 70% of TTP cases no precipitating cause can be found and the~     majority of these patients have antibodies against ADAMTS 13. Plasma Exchange (PEX) was~     introduced in the management of TTP in 1977 and the mortality of TTP patients has since~     decreased from approximately 90% to 15-20%. PEX is essential in TTP treatment as plasma~     contains the missing enzyme ADAMTS 13.~      Rituximab (licensed and internationally used monoclonal antibody) selectively acts on white~     blood cells known as B-lymphocytes or B cells that produce the antibody to ADAMTS 13. By~     inhibiting ADAMTS 13 antibody production, ADAMTS 13 activity increases, resulting in~     remission. Rituximab has been used in our institutions in patients with acute TTP that are~     refractory to standard treatment - PEX. The resulting remission has been dramatic, with a~     non-toxic side effect profile and no patients to date has relapsed (longest follow-up 19~     months) following Rituximab therapy. Therefore, we plan to use Rituximab with PEX in patients~     who present with acute TTP.~   "
200592|NCT00937118|"~     The management of significant duodenal injuries and combined duodenal-pancreatic injuries~     continues to be challenging and controversial, and several techniques have been advocated~     over the years. One technique surgeons employ is the damage control/planned reoperation~     strategy. At the trauma center, the advent of damage control and other planned re-operation~     strategies has resulted in an evolution in the investigators management of duodenal~     lacerations and combined duodenal-pancreatic injuries. In this retrospective review, the~     investigators intend to quantify the investigators change in practice and to report its~     outcome compared to previous practice.~      Using the OHSU Trauma Laparotomy Outcomes Database, the investigators will identify all~     patients receiving trauma laparotomy for a duodenal or duodenal/pancreatic injury for a~     period of 20 years, from 1989-2009. A number of data points will be retrieved from patients'~     medical records, including but not limited to grade of duodenal injury, mechanism of injury,~     Injury Severity Score, and others.~   "
200593|NCT00937105|"~     This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and~     marketed lotrafilcon A (Ciba Vision, Air Optix Night & Day Aqua) soft contact lenses for~     daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic~     (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use~     will be followed for 1 year. The primary outcome is the risk of development of a corneal~     inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main~     exposure of interest is microbial contamination of study lenses.~   "
200594|NCT00937092|"~     The aim of this study is to compare the effects of high-dose furosemide versus low-dose~     furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance,~     and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart~     failure.~   "
200596|NCT00937066|"~     This study is an economic evaluation of Symbicort (Budesonide/formoterol) as maintenance and~     reliever therapy (SMART) versus its competitive alternatives.~      The aims of this study are:~        -  To estimate the relative effectiveness of each one of the alternatives in the management~          of patients with moderate to severe asthma through a systematic review for the following~          outcomes:~             -  Cumulative incidence of asthma severe exacerbations symptoms~             -  Safety of each alternative (frequency of adverse events and complications due to~               the medications)~        -  To estimate the direct medical costs of treating with each pharmacologic alternative:~          Symbicort as SMART versus increased use of inhaled corticosteroids or Adding long-acting~          inhaled beta 2 agonist plus inhaled corticosteroids.~        -  To create a decision analysis model (decision tree) that allows comparisons between the~          alternatives on expected values and costs.~        -  To calculate the average and incremental cost-effectiveness ratios.~        -  To carry out a sensitivity analysis to test de robustness of the cost-effectiveness~          results allowing for reasonable changes in expected values and costs.~   "
200597|NCT00937053|"~     The purpose of this study is to determine if maintaining a high hemoglobin level in children~     that underwent bone marrow transplant will accelerate the neutrophil recovery.~   "
200598|NCT00937040|"~     The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated~     with OROS MPH to those treated with placebo.~   "
200599|NCT00937027|"~     The purpose of this study is to compare the safety and pharmacokinetic properties (the~     absorption, distribution and excretion) of two preparations of aminopterin (0.25 mg tablets~     and 1.0 mg tablets) following oral administration by subjects with moderate to severe~     psoriasis.~   "
200600|NCT00937014|"~     The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day)~     of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the~     first four months of life as compared to infants fed a standard infant formula.~   "
200601|NCT00937001|"~     ICU-acquired weakness represents a common and often devastating disease process which affects~     greater than 50% of critically ill patients. This pathogenesis of this acquired disease is~     multifactorial and results in variable severity, ranging from mild, transient to severe,~     permanent dysfunction of peripheral nerves in additional to muscle. In affected patients,~     weakness may persist for months to years after the acute phase of their illness, and has been~     implicated as a major contributor to decreased functional status and quality of life. Muscle~     ultrasound has been validated for assessment of muscle size as well as diagnosis of myopathic~     and neuropathic changes in patients with other known neuromuscular diseases. The use of~     muscle ultrasound or other imaging modalities for diagnosis or monitoring of ICU-acquired~     weakness has not been studied, although a single study using muscle ultrasound has shown~     significant change in muscle size in ICU patients receiving high dose corticosteroids and a~     prolonged course of paralytic agents. The investigators plan to use multiple modalities to~     examine skeletal muscle catabolism, function, and structure in patients during critical~     illness and recovery. The investigators will combine physical exam, hand grip dynamometry,~     electrophysiologic studies, serum biomarkers, muscle biopsies, and muscle ultrasound to~     assess a group of critically ill patients during their hospital stay. The investigators will~     obtain additional data, including neuropsychiatric assessments, severity of illness scores,~     administration of potentially harmful medications, and pertinent daily laboratory data. This~     study will last approximately 12 months.~   "
200602|NCT00936988|"~     This multicenter, open-label, single-arm, extension study was designed to evaluate long-term~     tolerability, safety, and efficacy of cinacalcet. Subjects were enrolled immediately after~     they completed the parent study, 990120. All subjects began treatment with 30 mg cinacalcet~     twice daily (BID), with dose adjustments made per protocol-specified guidelines. The study~     consisted of 2 consecutive phases that occurred in the following order: a dose-titration~     phase lasting 12 weeks and a maintenance phase lasting approximately 4½ years.~   "
200603|NCT00936975|"~     This phase II trial is studying how well fluorine F 18 sodium fluoride positron emission~     tomography (PET) works in evaluating response to dasatinib in patients with prostate cancer~     and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride PET, may~     help doctors predict a patient's response to treatment and help plan the best treatment.~   "
200604|NCT00936962|"~     The purpose of the study is to see which of the three current provincial Meningococcal C~     Conjugate vaccine schedules in Canada provide the longest lasting protection against~     Meningococcal C disease and to see if a booster vaccination is needed.~   "
200605|NCT00936949|"~     It has been reported that the operative approaches have an effect on clinical outcome in~     total hip arthroplasty. The purpose of this prospective study was to compare clinical and~     radiological outcomes between anterolateral approach and posterolateral approach in total hip~     arthroplasty.~   "
200606|NCT00936936|"~     The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy~     can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs~     gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will~     include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug~     combinations will also be studied.~      This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin,~     and etoposide are all FDA-approved and commercially available for the treatment of germ-cell~     tumors.~      Up to 67 patients will be enrolled in this study.~   "
200607|NCT00936923|"~     A prospective, randomized, open-label, stratified, controlled clinical trial to evaluate~     whether long term furosemide therapy (1 year) would preserve urine volume and/or residual~     renal function (RRF) and improve fluid state in continuous ambulatory peritoneal dialysis~     (CAPD) patients.~   "
200641|NCT00936481|"~     Obstructive sleep apnea is a condition in which people have decreased breathing during their~     sleep. Untreated sleep apnea has been linked to increased risk for cardiovascular diseases.~      This research study is looking at blood clotting factors and blood vessel function in health~     volunteers and patients with newly diagnosed or untreated obstructive sleep apnea to better~     understand the underlying mechanisms for increased cardiovascular risk.~   "
200642|NCT00936468|"~     This study is designed to determine the optimal dose of JVRS-100 and assess safety,~     tolerability and immunogenicity of Fluzone® vaccine administered with JVRS-100 adjuvant at~     one of three dose levels compared to Fluzone® vaccine administered alone, in 472 adults aged~     ≥65 years.~   "
200608|NCT00936910|"~     The purpose of this study is to evaluate the usefulness of antifungal lock therapy with~     liposomal amphotericin B (Ambisome), in combination with systemic antifungal(s), in patients~     with catheter-related blood stream infections with fungal organisms, whose catheter has not~     been removed because of the continuing critical need for central line access. The primary~     group of potential patients will be those with intestinal insufficiency, including post-op~     small bowel transplant recipients.~      The recommendation of the Infectious Disease Society of America (IDSA) is to remove all~     catheters with fungal infections and treat systemically for 14 days after the last positive~     culture. However, in certain intestinal failure patients, removal of an infected line might~     significantly reduce or eliminate intravenous (IV) access and create a life threatening~     situation. Thus, the investigators' aim is to determine the usefulness of antifungal lock~     therapy in intestinal failure patients whose catheter has not been removed. The~     investigators' hope is to salvage central line catheters rather than to remove them.~   "
200609|NCT00936897|"~     This is a multi-center, randomized, open-label, parallel group, study being conducted in the~     United States and in Europe in postmenopausal women. Approximately 800 subjects will be~     randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or~     ibandronate 150mg PO QM.~   "
200610|NCT00936884|"~     The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of~     subcutaneous (injection beneath the skin) MOA-728 versus placebo in Asian Adult subjects with~     opioid-induced constipation and advanced illness~   "
200611|NCT00936871|"~     This study has been designed to investigate the effect of lersivirine on the QT/QTc interval~     in order to help establish the safety profile of lersivirine.~   "
200612|NCT00936858|"~     Since thyroid cancer becomes refractory to radioactive iodine, treatment options are very~     limited. Tyrosine kinase inhibitors such as sorafenib have recently shown promise. This trial~     seeks to expand treatment options for this disease with a new, oral drug called RAD001. It is~     an inhibitor of the mTOR pathway and has shown activity in neuroendocrine cancers of the~     gastrointestinal tract and has been approved for the treatment of metastatic renal cell~     cancer.~   "
200613|NCT00936845|"~     To collect and analyze data on females with hemophilia so as to better define the difference~     between the study population and the male population with hemophilia.~   "
200614|NCT00936832|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) together with~     sunitinib malate may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving sunitinib malate together with~     combination chemotherapy works as front-line therapy in treating patients with metastatic~     rectal cancer that cannot be removed by surgery.~   "
200615|NCT00936819|"~     This will be the first clinical trial to include a strategy designed to enhance the function~     of autologous progenitor cells by overexpressing eNOS, and the first to use combination gene~     and cell therapy for the treatment of cardiac disease.~   "
200616|NCT00936806|"~     Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during~     anaesthesia.~   "
200617|NCT00936793|"~     Patients with human immunodeficiency virus (HIV) and respiratory disease commonly require~     protease inhibitors (PIs) and orally inhaled corticosteroids. Inhaled corticosteroids alone~     do not generally cause systemic adverse effects because of low systemic bioavailability, but~     the combination of inhaled fluticasone and various PIs has led to increased systemic~     fluticasone levels and multiple cases of secondary adrenal insufficiency. A study in healthy~     volunteers showed > 350-fold increase in fluticasone area under the curve when ritonavir~     (RTV) 100mg twice daily was coadministered with intranasal fluticasone compared to intranasal~     fluticasone alone. The mechanism of this drug interaction is presumably secondary to PI~     inhibition of cytochrome P450 3A4, the enzyme responsible for fluticasone metabolism. As a~     result, inhaled fluticasone is not recommended in combination with most PIs unless the~     benefit outweighs the risk. One possible alternative to fluticasone is inhaled~     beclomethasone, which has not been studied in combination with PIs. Although beclomethasone~     also undergoes metabolism via CYP3A4 in vitro to its more active metabolite,~     beclomethasone-17-monopropionate, it appears to be largely hydrolyzed by esterases in vivo.~     Furthermore, the pharmacokinetic properties of beclomethasone-17-monopropionate, such as~     relatively short half-life, low maximum plasma concentration, and low volume of distribution,~     suggest that systemic accumulation leading to significant adverse effects is unlikely even in~     the presence of a CYP3A4 inhibitor such as a PI.~      In this open-label study, 46 subjects will receive inhaled beclomethasone for 6 weeks from~     Days 1 to 42. Subjects will be randomized into 1 of 3 groups, such that from Days 15 to 42,~     18 subjects will add no additional study drugs, 14 subjects will add RTV 100mg twice daily,~     and 14 subjects will add DRV/r 600/100mg twice daily. Pharmacokinetic sampling for~     beclomethasone and beclomethasone-17-monopropionate levels will occur on Days 14 and 28.~     Pre-cosyntropin cortisol levels and a low-dose adrenocorticotropic hormone (ACTH) stimulation~     test will be performed on all subjects on Days 1, 14, 28, and 42. Data from this~     investigation will determine whether RTV and/or DRV/r, potent CYP 3A4 inhibitors, alter the~     pharmacokinetics of beclomethasone and its active metabolite,~     beclomethasone-17-monopropionate (primary objective), and whether or not a possible increase~     in systemic bioavailability of beclomethasone and beclomethasone-17-monopropionate alters~     pre-cosyntropin cortisol levels and responses to ACTH stimulation test over a 4-week period~     (secondary objective). Results from this investigation will provide pharmacokinetic and~     pharmacodynamic data to assist clinicians in determining whether inhaled beclomethasone is an~     appropriate option in HIV-infected patients requiring concomitant therapy with an inhaled~     corticosteroid and PIs.~   "
200618|NCT00936780|"~     The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the~     Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.~   "
200619|NCT00936767|"~     It has now been demonstrated clearly that in Western Cambodia parasitological responses to~     artesunate and artemether containing treatment regimens for uncomplicated falciparum malaria~     are slower than elsewhere in the world. Median parasite clearance time (PCT) in patients~     treated with artesunate 4 mg/kg/day was 78 hours and with 2 mg/kg/day 82 hours, compared to~     54 and 48 hours, respectively, in Western Thailand; at 72hours peripheral blood parasitaemia~     was still detectable in 55% of patients in Western Cambodia, compared to 7.5% in Western~     Thailand. Although occasional poor responses to artesunate have been described previously the~     current reports suggest a consistent problem. These antimalarials are central to current~     treatment strategies, and so spread of parasites with reduced artemisinin susceptibility~     outside this area would be a disaster. A recent consensus meeting Pnomh Penh agreed that this~     should indeed be termed resistance, and represented a major threat to malaria control.~     Radical containment measures would be needed. This study aims to address whether a~     semi-synthetic or fully synthetic peroxide antimalarial would be more effective than~     artesunate and could therefore be used in Cambodia as part of the elimination strategy.~     Artemisone is a semisynthetic derivative of dihydroartemisinin, which importantly changes its~     tertiary structure. This drug has also shown promising efficacy for the treatment of~     uncomplicated falciparum malaria in phase II trials in Thailand and seems to be at least as~     efficacious as artesunate. No significant toxicity has been reported for artemisone and it is~     very well tolerated. If sensitivity for artemisone has remained intact in Western Cambodia,~     this will have important implications for the strategies available for containment of the~     threatening problem of artesunate resistance in Western Cambodia. It will also have important~     implications for further development of these drugs for the use in artemisinin combination~     therapies (ACTs).~   "
200665|NCT00936169|"~     The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS)~     optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions~   "
200625|NCT00936689|"~     Background~      Hepatic intra-arterial chemoembolization (TACE) is proposed when potentially curative therapy~     (eg. surgical resection, percutaneous ablation)is no longer possible. Prospective and~     non-randomized retrospective studies showed TACE to be capable to increase survival vs~     controls. In 2002 the first results of two RCTs were published which had been conducted on~     unresectable HCC patients, designed to assess the impact produced by TACE on survival,~     demonstrated a statistically significant advantage in TACE treated patients compared to~     controls. The same results have been confirmed by a meta-analysis conducted on 14 trials~     published in literature. The limitations of TACE are represented however by the difficulties~     in obtaining a complete necrosis of the lesion treated and for this reason new embolization~     agents are being developed to increase the efficacy of TACE in HCC as the microsphere, in~     poly vinyl alcohol and co-acrylic acid that are not reabsorbable and induce permanent~     embolization. The first experimental studies using microsphere showed the good tolerability~     and the higher rate of tumor necrosis, but no RCTs have been conducted to investigate their~     impact on survival. Objectives. The primary aim of this study is to compare 2 years survival~     of patients randomized to selective traditional TACE or selective TACE via microspheres~     loaded with Doxorubicin. Secondary objectives investigate the time to progression of disease~     (radiologic and symptomatic) by radiologic, laboratory tests and the QoL questionnaire~     administration. Methods. This is a multicentre, randomized, open-label, active controlled~     study in HCC patients treated with standard TACE vs TACE with doxorubicin - loaded~     microsphere. The study comprises a selection period, a treatment period and a follow up phase~     with a total duration of 2 years from randomization. Expected results. The sample size(alfa~     5%, power 80%) is adequate to detect a 20% difference between TACE with microsphere vs~     traditional TACE.~   "
200626|NCT00936676|"~     Eligible participants, who participated in the ADAGIO trial and who sign an approved informed~     consent form, will be enrolled into the study at their original study locations. participants~     who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical~     benefit from restarting treatment can also be considered for enrollment in the Core follow-up~     study period. Use of any other anti-PD treatment is permitted as deemed necessary by the~     treating physician (according to the participants clinical status).~   "
200627|NCT00936663|"~     This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin~     resistance) will delay or prevent kidney transplant patients from getting diabetes.~   "
200628|NCT00936650|"~     This randomized, placebo-controlled study in patients with primary HPT was designed to~     evaluate the efficacy, safety, pharmacokinetics, and health-related quality of life (HRQOL)~     of AMG 073 when administered 2 times a day (BID). The study consisted of 3 phases: a 12-week~     dose-titration phase, a 12-week maintenance phase, and a 28-week follow-up phase.~   "
200629|NCT00936637|"~     The purpose of this study is to assess growth in infants who are fed an extensively~     hydrolyzed formula.~   "
200630|NCT00936624|"~     This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent~     asthma.~   "
200631|NCT00936611|"~     The purpose of this research study is to assess the response rate of LBH589 in patients with~     relapsed or refractory Waldenstrom's Macroglobulinemia. LBH589 is a newly discovered compound~     that has killed Waldenstrom cells in laboratory studies, however, it is not known if LBH589~     will show the same activity in people with Waldenstrom's Macroglobulinemia. This drug has~     been used in research for the treatment of other types of cancer, such as multiple myeloma.~   "
200632|NCT00936598|"~     This study proposes to test the hypothesis that zolpidem taken the night before major surgery~     for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as~     reduce the need for analgesic medication.~   "
200633|NCT00936585|"~     The objective of this NIH-specific substudy is immunologic monitoring of cytokine and immune~     cell responses in subjects undergoing treatment with AIN457 (human monoclonal anti-human~     interleukin-17A) for moderate to severe Crohn's disease. Recent data suggests that~     interleukin-17 (IL-17) is an important mediator of inflammation in certain animal models of~     Crohn's disease, and treatment aimed at blocking the IL-23-IL-17 axis can ameliorate the~     inflammatory changes. In addition, elevated expression of IL-l7 has been found in the gut~     tissue of patients with active Crohn's disease. This substudy will measure changes in~     cytokine production, relevant RNA expression, and immune cell populations (in the periphery~     and lamina propria) for correlation with clinical outcomes in order to explore the mechanisms~     of therapeutic response.~   "
200634|NCT00936572|"~     Design: double blind controlled randomized trial with a parallel design and 3 treatment~     groups Description of subjects: Patients admitted in study centers for colorectal surgery~     under laporoscopy and/or laparotomy.~      Product:~      Product 1: BB536 and LA1 (10E9) Product 2: BB536 and LA1 (10E7) Placebo: Maltodextrin Number~     of patients: enrolled subjects: n=33, ITT data set: n=31, PP data set: n=30~      Primary objective:~      Colonization (biopsy+stools) of each bacteria for one of the dose at D0 (surgical procedure)~      Secondary objectives:~        -  Influence of the probiotic bacteria on the gut microflora~        -  Modulation of the immune and inflammatory response~      Additional objectives:~        -  Investigate dose effect on La1 colonization~        -  Investigate the effect of La1 colonization, treatment without La1 colonization, and~          absence of treatment and La1 colonization on other bacteria and on immunological~          parameters~   "
200635|NCT00936559|"~     Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full~     thickness Rotator Cuff Tears (RCTs).~   "
200636|NCT00936546|"~     This study will evaluate the safety and efficacy of the combination of rituximab and~     methotrexate to treat disabling fibrosing skin disorders.Rituximab will be administered at~     baseline and month 6. The drug will be considered efficacious if the skin thickness~     diminishes substantially.~   "
200637|NCT00936533|"~     This study evaluates the clinical effect of foot injection of the bacteria protein Botulinum~     toxin A on plantar pain in patients with EBS (epidermolysis bullosa simplex) or PC~     (pachyonychia congenita).~   "
200638|NCT00936520|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of~     SAR 1118 within the anterior and posterior chamber of the eye and plasma in subjects~     undergoing elective vitrectomy when treated with escalating concentrations of the study drug~     for approximately 1 week.~   "
200639|NCT00936507|"~     The purpose of this randomized controlled study using a crossover design is to investigate~     the main effect of portion size and food type (low-energy dense vs. high-energy dense) on~     caloric intake.~   "
200640|NCT00936494|"~     This study will examine whether treatment of inferior turbinates in patients with continued~     symptoms of obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed~     sleeping, open mouth breathing, and upper airway resistance syndrome after tonsillectomy and~     adenoidectomy will improve these symptoms and should be included in the treatment paradigm~     for treatment of sleep related breathing disorders in infants, children, and adolescents.~   "
200643|NCT00936455|"~     SPECIFIC AIM: The specific aims of this study are to evaluate the long term outcomes of~     patients previously enrolled in the STRokE DOC (STRokE DOC Trial (NCT00283868))~     telemedicine clinical trial.~      AIM 1: Aim 1 is a non- randomized, retrospective, data collection study assessing long term~     patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical~     trial (STRokE DOC Trial (STRokE DOC Trial (NCT00283868)); now completed). STRokE DOC-LTO~     will evaluate, (only for those patients previously enrolled in the original telemedicine vs.~     telephone clinical research trial), the long term patient outcomes; comparing telemedicine~     versus telephone-only consultations.~   "
200644|NCT00936442|"~     ARTEMIS is a study to assess how educational material affects overall adherence to~     anastrozole by evaluation of patients' electronically compiled dosing histories. Patients'~     dosing times are compiled electronically using Medication Event Monitoring System (MEMS®) in~     order to be able to gather accurate, objective and up-to-date patients' dosing histories. For~     subjects in Group A, the control group, the adherence to anastrozole in the standard clinical~     practice will be evaluated. For subjects in Group B, on top of the standard clinical~     practice, they will also receive educational material by mail at week 0 (study registration),~     week 2, week 4, week 6, week 8, week 12, month 5, month 7, and at month 10. This procedure is~     the same as in the ongoing CARIATIDE study. One of the reasons of poor adherence (either~     early discontinuation of the treatment or missing doses while still engaged to the therapy)~     can be some side effects experienced by the patients during the anastrozole treatment.~     Recording the reasons at discontinuation allows us to identify reasons for treatment~     discontinuation. Recording reasons of anastrozole interruptions during the study period~     allows us to relate these events to patients' adherence to anastrozole. During the study, no~     pro-active safety data collection will take place. Spontaneous reported adverse drug~     reactions (ADRs) will be reported according to local post-marketing pharmacovigilance~     regulations.~   "
200645|NCT00936429|"~     This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and~     tolerability of HBV-001 D1 in healthy adult subjects.~   "
200646|NCT00936416|"~     Estimation of Glomerular Filtration Rate (GFR) is the primary test used to assess patients~     with renal disease. Although serum creatinine based GFR and nuclear medicine based~     estimations are routinely used in clinical practice, GFR estimation by Inulin is the~     recommended gold standard. Inulin based estimation of GFR is cumbersome and time consuming.~      A decrease in blood flow to the kidney (Renal Blood Flow (RBF)) is known to cause a decrease~     in GFR. RBF is typically determined using radioactive tracers, contrast MRI or a cumbersome~     para-aminohippuric acid (PAH) clearance method.~      MRI based assessment of GFR and RBF have been suggested to provide reasonable accuracy. Most~     of these studies did not compare the GFR and RBF estimation directly to Inulin and PAH~     clearance which are ther gold standards . In this study we propose to estimate MRI based GFR~     estimation directly to Inulin and noncontrast MRI based derived RBF to PAH to assess if MRI~     is an accurate test of kidney function.~   "
200647|NCT00936403|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety, tolerability, pharmacokinetics (the determination of the concentration of the~     administered medication in blood over time) and pharmacodynamics (the determination of the~     effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in~     growth hormone deficient children.~   "
200648|NCT00936390|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells.~     Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not~     yet known whether radiation therapy is more effective with or without androgen-deprivation~     therapy in treating patients with prostate cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared with radiation therapy given together with androgen-deprivation therapy in~     treating patients with prostate cancer.~   "
200649|NCT00936377|"~     This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol~     withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive~     dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while~     maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a~     dose-dependent profile of action when it is used for this indication. In addition, this study~     will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and~     potential serum biomarkers of alcohol withdrawal.~   "
200650|NCT00936364|"~     This partially randomized clinical trial studies short-term fasting in reducing side effects~     in patients receiving gemcitabine hydrochloride and cisplatin for advanced solid tumors.~     Short-term fasting before chemotherapy may reduce the side effects caused by chemotherapy.~     Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing.~   "
200651|NCT00936351|"~     The purpose of this study is to develop a treatment manual for mindfulness meditation to be~     taught in a group format to individuals with schizophrenia who are engaged in vocational~     rehabilitation. This study will also determine whether mindfulness meditation is beneficial~     in terms of improving work function by reducing distressing emotional states and thinking~     patterns.~   "
200652|NCT00936338|"~     The effectiveness of physical therapy for treatment of anterior disc displacement without~     reduction of temporomandibular disorders has not been well defined. This study compared the~     treatment method with conservative splint therapy. Fifty two subjects were assigned at random~     to either of two treatment groups: one is a splint treatment group, and the other is a joint~     mobilization self exercise group. Each treatment was evaluated using four outcome variables:~     (i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and~     (iv) limitation of daily activities. All outcome variables were significantly improved after~     eight-week of treatment in the exercise group. Meanwhile, the splint treatment improved three~     variables, other than mouth opening with pain; however, the degree of improvement was less~     than that seen in the exercise group. This result demonstrates that the joint mobilization~     self exercise improves jaw function and relieves pain as compared to the splint treatment.~   "
200666|NCT00936156|"~     Primary objective : To increase the 3 year progression-free survival from 40% to 60%.~     Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged~     over 5 years.~   "
200653|NCT00936325|"~     Background:~        -  Systemic Capillary Leak Syndrome (SCLS) is a disorder of unknown cause characterized by~          episodes of life-threatening drop in blood pressure and leakage of fluids into tissues.~          The outcome from an episode of SCLS may be mild and resolve on its own, or may be severe~          and result in death. Although SCLS likely involves abnormalities in the cells lining~          blood vessels, the specific cause(s) of this disorder are not known.~        -  The treatment of choice for an acute SCLS episode is intravenous fluids and drugs such~          as norepinephrine (adrenaline), which are given to keep blood pressure at a level that~          will maintain vital organ function. This may be followed by a course of intravenous~          steroids and IVIG. Currently, there is no cure, but IVIG has been effective in~          diminishing the frequency and/or intensity of SCLS episodes when given regularly, as~          long-term effective preventive therapy for many patients who experience recurrent~          episodes of SCLS.~        -  This protocol is focused on understanding what causes SCLS with the hope that research~          findings will lead to the design of safe and more effective treatments.~      Objectives:~      - To investigate mechanisms that may cause Systemic Capillary Leak Syndrome.~      Eligibility:~        -  Patients between 16 and older who have been diagnosed with SCLS. Patients who have been~          diagnosed with SCLS and are between the ages of 7 and 16 may participate off-site, by~          sending specimens to the NIH. Patients 16 and older who have been diagnosed with SCLS~          and cannot travel to the NIH may also participate off-site.~        -  Patients must have a documented history of at least one episode of SCLS with all three~          of the following documented on at least one occasion: low blood volume, low blood~          pressure without cause, and evidence of protein leakage during the episode. A letter of~          a referral from a treating physician is also required.~      Design:~        -  Patients seen on site will be evaluated at the National Institutes of Health (NIH) for~          approximately 4 to 5 days on an inpatient basis, and will undergo the following~          procedures:~             -  Medical history and physical examination.~             -  Blood samples for evaluation and research purposes, as well as possible genetic~               testing.~             -  Apheresis procedure, if needed, to obtain a larger volume of blood cells for~               research.~             -  Bone marrow biopsy, if medically indicated.~             -  Other medically indicated tests, such as skin tests to check for possible allergic~               reactions.~        -  Patients who have a capillary leak episode while at NIH will be treated with the~          standard of care for treating SCLS.~        -  Patients will be discharged from the protocol 1 year after the NIH visit.~        -  Patients participating off-site will be asked to collect and send specimens (such as~          blood) to the NIH for research purposes and evaluation.~        -  Unaffected Biological relatives of SCLS patients and Unrelated Normal Volunteers may~          also enroll on the study. Relatives and Normal Volunteers may be asked to provide~          research samples for the study, such as skin biopsy and research blood specimens.~   "
200654|NCT00936312|"~     This is a multi-center, international study designed to collect clinical, genetic and quality~     of life information on females with hemophilia, an inherited bleeding disorder. The study is~     designed to determine whether there are problems and issues unique to females with~     hemophilia.~   "
200655|NCT00936299|"~     Attention deficit hyperactivity disorder (ADHD) is one of the most common co-occurring~     psychiatric disorders (30-50%) in adolescents with substance use disorders (SUD). Yet, little~     is known about the safety and efficacy of medications for ADHD in adolescents with SUD, since~     such youths have been excluded from most medication trials. Clinicians are therefore~     understandably reluctant to treat ADHD in substance abusing adolescents, often first~     referring such youths to substance treatment. Untreated ADHD is associated with poorer~     substance treatment outcomes. We address this research gap by proposing a randomized~     controlled trial of bupropion vs placebo in 130 adolescents (13-19 years) with Diagnostic and~     Statistical Manual (DSM IV) ADHD, nicotine dependence and cannabis use disorder (not~     excluding other SUD). Participants in both bupropion and placebo treatment groups will~     receive weekly individual manualized-standardized cognitive behavioral therapy (CBT)~     targeting SUD (at no cost to them) throughout the 16 weeks of the medication trial. Bupropion~     also is effective in treating nicotine dependence in adults; the majority of adolescents with~     marijuana and other drug abuse also smoke tobacco. More recent research in adults indicates~     that bupropion may reduce craving and use of other substances of abuse (e.g. methamphetamine,~     cocaine). It's possible impact on cannabis use disorder (the addiction for which most teens~     are referred to treatment) has not yet been evaluated. However since all drugs of abuse have~     a final common pathway leading to addiction via action in the so called brain reward system~     (ventral tegmental area (VTA), accumbens) -an important secondary aim is to evaluate~     bupropion's potential impact on craving and use of marijuana (MJ) in addition to its known~     similar action on nicotine.~   "
200656|NCT00936286|"~     The purpose of this study is to determine whether respiratory muscle training by means of~     normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with~     mild to intermediate sleep apnea syndrome.~   "
200657|NCT00936273|"~     The purpose of this study is to determine the double loop index (DLI) threshold with optimal~     sensitivity and specificity. The investigators hypothesize that the DLI gives a better~     reflection of the pathophysiology of the disease than the apnea-hypopnea-index (AHI).~   "
200658|NCT00936260|"~     The purpose of this study is to determine the duration of the treatment with alendronate in~     postmenopausal women with osteoporosis.~   "
200659|NCT00936247|"~     This investigational study will investigate two different volume replacement regimes in~     patients suffering from compromised renal function.~   "
200660|NCT00936234|"~     SDF-1, an important cytokine for neovascularisation is cleaved by (dipeptidyl peptidase IV)~     DPPIV.~      The aim of this study is to assess the effect of the dipeptidyl peptidase IV inhibitor~     vildagliptin (Galvus®) on endothelial function as well as number and functional activity of~     progenitor cells in patients with documented diabetes mellitus.~   "
200661|NCT00936221|"~     To assess the efficacy in terms of overall survival of AZD6244 in combination with~     dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation~     positive advanced cutaneous or unknown primary melanoma~   "
200662|NCT00936208|"~     PRO-POWER is an observational cohort study for a period of 24 weeks. All recruited patients~     will have essential hypertension. In addition, the patients will have at least one other~     contributing risk factor for cardiovascular events. The study aims to evaluate the safety,~     efficacy and protection of Micardis 80mg/Micardis plus 80/12.5mg from cardiovascular risks in~     patients with essential hypertension~   "
200663|NCT00936195|"~     To assess the maternal and infant safety of a single daily fixed-dose combination of~     TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and~     3TC/ZDV (Combivir®) given to African women to prevent overall MTCT in populations practicing~     breastfeeding.~   "
200664|NCT00936182|"~     Antifungal therapy is widely used for individuals with Autism Spectrum Disorders (ASD). The~     current investigation will examine the effects of fluconazole on behavioral functioning among~     children with ASD. This is a double-blind, randomized, placebo-controlled study of oral~     fluconazole in children who meet criteria for ASD. Pre- and post-treatment behavioral ratings~     will be used to evaluate the efficacy of fluconazole therapy. In addition, children will~     undergo comprehensive medical history, physical examination, and laboratory analyses.~      Our objective is to quantify differences in behavioral functioning between the fluconazole~     treatment and a placebo. Our primary hypothesis is that, on average and relative to the~     placebo, children with ASD who receive fluconazole will show greater improvements in symptoms~     of autism.~   "
200667|NCT00936143|"~     This is a prospective open-label study to evaluated the efficacy and safety of~     infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS).~     Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th~     week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes~     include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not~     necessary. The adverse events at any time were recorded.~   "
200668|NCT00936130|"~     The purpose of the study is to determine the effect of three weight loss surgeries compared~     to a low calorie diet with regard to energy expenditure, body composition, insulin~     sensitivity, and the response of gastrointestinal peptides to a standard meal. Baseline~     assessments will be conducted in all four groups and changes will be compared six and~     fifty-two weeks post-operatively.~   "
200669|NCT00936117|"~     The goal of this clinical research study is to learn the amount of posaconazole that is in~     the body at different time points when given to patients with leukemia. The safety of this~     drug will also be studied.~      Objectives:~      Primary:~      To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute~     myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing~     induction chemotherapy or relapsed or refractory patients who will receive salvage~     chemotherapy.~      Secondary:~      To evaluate the safety of posaconazole given as prophylaxis.~   "
200670|NCT00936104|"~     In the current project we aim to study the oncological process of pancreatic cancer, from a~     perspective of the CSC-theory and in particular through the 'side population' (SP)-approach.~     The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After~     isolation from pancreatic cancer resection specimens, SP cells will be characterized by~     gene-expression profiling based on microarray analysis. We'll identify markers and pathways~     (with emphasis for stem cell and cancer -related ones) that are differentially expressed in~     SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the~     prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring~     technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective~     database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents~     in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant~     molecular targets and pathways obtained from the Nanostring results.~   "
200671|NCT00936091|"~     Intestinal parasitic infections, malnutrition and iron deficiency anaemia (IDA) are still~     considered as public health problems in rural Malaysia especially among Orang Asli children.~     Despite intermittent control programmes, the prevalence of these problems is still high~     suggesting the need of other control and interventions measures. This randomized~     double-blind, placebo-controlled trial was carried out among Orang Asli schoolchildren from~     Sekolah Kebangsaan Betau in Pos Betau, Pahang (200 km northeast Kuala Lumpur) to investigate~     the effects of vitamin A supplementation on intestinal parasitic reinfections, growth, iron~     status and educational achievement.~      HYPOTHESES~        1. Vitamin A supplementation has a negative effect on intestinal parasitic reinfections and~          the worm burden of infections among Orang Asli schoolchildren in Pos Betau, Kuala Lipis,~          Pahang.~        2. Vitamin A supplementation has a positive effect on growth (weight and height) among~          Orang Asli schoolchildren.~        3. Vitamin A supplementation is effective in improving serum iron status among Orang Asli~          schoolchildren.~        4. Vitamin A supplementation has a positive effect on cognitive function and educational~          achievement among Orang Asli schoolchildren.~   "
200672|NCT00936078|"~     Living kidney donors and non-donor controls will be studied before and after the living donor~     transplant. The donor and non-donor will be followed for up to 5 years. The purpose of this~     study is to see if there are any differences between the two groups in regards to blood~     pressure, rate of hypertension, kidney function and psychological well being and economical~     status.~   "
200673|NCT00936065|"~     To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a~     maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice~     Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.~   "
200674|NCT00936052|"~     Standard treatment for glioblastomas includes radiation and chemotherapy with a drug called~     temozolomide (Temodar); however, glioblastomas frequently develop resistance to standard~     treatment and recur or progress. Glioblastomas are known to have decreased levels of oxygen~     compared to normal tissues. There is evidence that these lower oxygen levels in glioblastomas~     may contribute to their ability to resist treatment effects of radiation and chemotherapy. In~     this study we will look to increase the oxygen concentration within the glioblastoma by~     adding hyperbaric treatments (the experimental part of this study) to standard treatment with~     radiation and temozolomide in order to see whether increasing the oxygen concentration within~     the tumor increases the tumor-killing ability of standard radiation and chemotherapy.~      In addition, the investigators are interested to evaluate the effect of this treatment~     protocol on a person's quality of life and level of stress, and, therefore, the investigators~     will ask subjects to complete several brief questionnaires while they are on-study.~   "
200675|NCT00936039|"~     In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber~     characteristics will be determined. In addition, the effects of 6 weeks of recovery will be~     assessed.~   "
200676|NCT00936026|"~     Primary:~      To assess the effects of CYP2B6 inhibition by repeated dose Clopidogrel (75 mg/day)~     co-administration on the single-dose pharmacokinetics of Neramexane~      Secondary:~      To assess safety and tolerability of Neramexane single dose treatment alone and~     co-administration of a Neramexane single-dose with a Clopidogrel repeated dose treatment~   "
200677|NCT00936013|"~     The purpose of the study is to determine whether the combination treatment of Chinese~     medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel~     influenza A (H1N1) pneumonia.~   "
200678|NCT00936000|"~     Alcohol is one of the most commonly abused drugs in the world. Up to 40% of medical and~     surgical patients have alcohol related problems, and alcohol use accounts for more than 10%~     of U.S. health care costs. In the intensive care unit (ICU), patients with a history of~     alcohol abuse are common where their rates of mortality and ICU-related morbidity are~     significantly higher when compared to patients without a history of alcohol abuse. Though ICU~     patients are a heterogeneous group, Acute Respiratory Distress Syndrome (ARDS), a devastating~     form of acute lung injury, is one of the more frequent diagnoses among these critically ill~     patients.~      In 1996, we made the novel observation that a prior history of chronic alcohol abuse is~     associated with an increased incidence and severity of ARDS in critically ill patients. In~     our epidemiological studies of over 570 critically ill patients, 50% of all patients with~     ARDS have a significant history of chronic alcohol abuse. Since ARDS affects approximately~     150,000 patients per year in the United States, and mortality is 40-50% even in previously~     healthy individuals, alcohol-related ARDS is an enormous national health care problem. We~     estimate that between 15,000 and 25,000 deaths per year in the United States are associated~     with alcohol-related ARDS, a number consistent with or even exceeding the number of deaths~     due to many other alcohol-related diseases such as cirrhosis of the liver and alcohol-related~     traffic accidents. Further investigations of the association between chronic alcohol abuse~     and ARDS are needed to develop therapies that improve morbidity and mortality in this~     important patient population.~      The clinical syndrome of ARDS is defined as refractory hypoxemia with bilateral infiltrates~     on chest radiograph in the absence of left atrial hypertension. Pathophysiologically, ARDS is~     characterized by diffuse alveolar damage, increased pulmonary alveolar-capillary~     permeability, and the subsequent accumulation of extravascular lung water. In animal models~     of chronic alcohol abuse, we showed that chronic ethanol ingestion causes chronic oxidative~     stress, depletes lung glutathione, impairs alveolar-capillary barrier function, and~     exaggerates endotoxin-mediated acute lung injury. Ethanol-mediated disruption of the~     alveolar-capillary barrier, and the associated susceptibility to acute edematous injury, is~     modified by glutathione (GSH) replacement therapy in animal models.~      Responding to NIH emphasis on studies of the mechanisms of disease and evaluation of~     therapies in human subjects, our group has initiated translational studies that expand our~     basic observations of the effects of chronic alcohol abuse on ARDS to the clinical setting.~     We recently reported that lung epithelial lining fluid from individuals with a prior history~     of chronic alcohol abuse is deficient in GSH, an essential antioxidant. The translational~     experiments outlined in this proposal will identify alterations in the structure and function~     of the lung in individuals with a history of chronic alcohol abuse and test a novel medical~     therapy that may ultimately decrease the morbidity and mortality for 50,000-75,000 ARDS~     patients with a prior history of chronic alcohol abuse per year in the United States.~      We propose the following hypothesis that antioxidant deficiency is a cause of abnormal~     alveolar-capillary barrier function in individuals with a history of chronic alcohol abuse,~     and oral anti-oxidant replacement therapy will correct the abnormality.~      If this hypothesis can be confirmed, this work would pave the way for testing antioxidant~     replacement as prophylaxis against acute lung injury in alcoholic patients at risk for the~     development of ARDS.~      Specific Aim: To determine the safety and efficacy of in vivo antioxidant replacement therapy~     on alveolar-capillary barrier function in individuals with a history of chronic alcohol~     abuse.~   "
200679|NCT00935987|"~     This study seeks to (i) determine a safe and tolerated dose of CYT387 given to patients with~     PMF, post-PV or post-ET and, (ii) assess the effectiveness of orally-administered CYT387 as a~     treatment for PMF, post-PV or post-ET.~   "
200680|NCT00935961|"~     The purpose of this study is to test the safety of RAD001 (everolimus) tablets at different~     dose levels, when added to docetaxel and cisplatin. The investigators want to find out what~     effects, good and/or bad, that everolimus has when added to docetaxel and cisplatin as~     treatment for head and neck cancer.~   "
200682|NCT00935935|"~     This study will look to see if there are changes in the blood cells that are associated with~     bone disease and sort out effects that are due to the HIV virus itself, the medications and~     see if faster aging occurs in the cells of HIV infected persons. Bone disease will be~     measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if~     someone has normal bone mass for their age or if there is thinning of the bones.~      The purposes of this study are:~        -  to learn how common bone disease is in HIV infected patients over the age of 50 years~          that receive their care at the CORE Center~        -  to see what are the common causes of bone disease in older HIV infected persons~        -  to see if there are differences in blood cells and levels of cytokines in patients who~          do or do not have bone disease, as this may help researchers determine the cause of bone~          disease.~   "
200683|NCT00935922|"~     The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma~     inflammatory markers, and insulin sensitivity.~      We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease~     triglyceride, total and LDL-cholesterol and increase HDL-cholesterol).~      Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG).~     Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and~     have been associated with cardiovascular benefits due to their antioxidant activity.~     Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL~     oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6),~     IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high~     density lipoprotein (HDL-SAA).~   "
200684|NCT00935909|"~     The primary purpose of this prospective, randomized trial is successful intravenous (IV)~     cannulation on first attempt with the use of either the Vein Viewer (VV) or standard~     cannulation method. The secondary purpose is to find out if there is a difference in the~     total time to successful cannulation.~   "
200685|NCT00935896|"~     Objective: To compare the effects of a protective versus a conventional ventilatory strategy,~     on systemic and in lung production of tumor necrosis factor-alpha (TNF-alpha) and~     interleukin-8 (IL-8) in patients without lung disease.~      Hypothesis: High tidal volumes induce inflammation in patients without lung disease Design:~     Prospective control-randomized study. Patients and Setting: Twenty patients without lung~     disease and submitted to mechanical ventilation admitted to one trauma and one general adult~     intensive care unit of two different university hospitals.~      Interventions: Patients were randomized to receive mechanical ventilation either with tidal~     volume (VT) of 10-12 ml/kg predicted body weight (high VT group) or with VT of 5-7 ml/kg~     predicted body weight (low VT group) with an O2 inspiratory fraction (FIO2) enough to keep~     arterial oxygen saturation > 90% with positive end-expiratory pressure (PEEP) of 5 cmH2O~     during 12 hours after admission to the study.~   "
200686|NCT00935883|"~     To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated~     by the change in drusen volume and area of geographic atrophy.~   "
200687|NCT00935870|"~     The main aim is to evaluate the long-term safety and bone healing in the operated area and to~     compare bioactive glass granules with autogenous bone as a filler material.~   "
200688|NCT00935857|"~     Patients with a prior incomplete colonoscopy will be enrolled in this study. Patients will be~     randomized to either an initial repeat attempt with a standard colonoscope or the single~     balloon enteroscope. If the procedures is unsuccessful, the patient can be crossed-over to~     the other group. The primary endpoint of the study is a complete colonoscopy.~   "
200689|NCT00935844|"~     This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose~     (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will~     help to identify the recommended phase 2 dose and infusion duration, and describe the~     pharmacokinetics of TAK-901.~   "
200690|NCT00935831|"~     The purpose of this study is to characterize the safety and tolerability of single doses of~     compound 1278863A in subjects with renal impairment.~   "
200691|NCT00935818|"~     This study provides an opportunity to combine varenicline and bupropion SR and capitalize on~     the potential additive benefit. The investigators hypothesize that this will further increase~     long-term (≥ 6 months) smoking abstinence rates.~   "
200692|NCT00935805|"~     The aim of this study is to to analyze if it is possible to reach the goals of HbA1c <7.0%~     and blood pressure <= 130/80 mm Hg in a cohort of patients with type 2 diabetes attending a~     primary care unit, using ony those resources available at the unit, and provided by the~     Brazilian National Health System. It is an open label, observational study, with a duration~     of 4-6 years. Patients attending a primary care outpatient facility will be sequentially~     included in the study provided they give consent. They will be followed on a monthly basis by~     a team of physicians and nurses. Glucose, A1c, Blood PRessure will be the outcomes.~   "
200693|NCT00935792|"~     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the signaling~     molecules needed for cell growth. Monoclonal antibodies, such as alemtuzumab, can bind to and~     kill malignant lymphocytes.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when~     given together with alemtuzumab and will see how well they work in treating patients with~     recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL).~   "
200694|NCT00935779|"~     Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma.~     Involved mechanisms are poorly understood though experimentally it has been demonstrated that~     neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of~     damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic~     microscopy in control subjects and in patients with early or locally advanced gastric cancer~     looking for spontaneous changes in peritoneal surface not related with surgical injury.~   "
200711|NCT00935558|"~     The primary aim of this study is to investigate time to progression in breast cancer patients~     vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant~     aromatase inhibitor (AI), Thymosin 1 alpha and interleukin-2. The secondary aim is to~     investigate whether a measurable immune response can be induced, and to evaluate the clinical~     effect (objective response rate) of the vaccination regime.~   "
200727|NCT00935350|"~     Reductions of postprandial glucose levels have been demonstrated previously with the addition~     of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This~     study explores whether these reductions are sustained when NVP is added to a range of~     commonly consumed foods.~   "
200695|NCT00935766|"~     The overall objective of LUCHAR Specific Aims 4.1 and 4.2 is to assess the additional~     contribution of cardiovascular disease (CVD) risk markers to traditional biomedical risk~     factors in the prediction of pre-clinical CVD. Specific Aim 4.3 will test the impact of~     omega-3 fatty acid supplementation on risk markers and pre-clinical markers of CVD in~     Hispanic patients.~      Specific Aim 4.3: Conduct a randomized, placebo-controlled trial of the effect of omega-3~     fatty acid supplementation on vascular function as measured by brachial artery reactivity~     (BAR) and on circulating inflammatory markers.~      Hypotheses:~        1. Daily omega-3 fatty acid supplementation will improve vascular function in subjects at~          high risk for CVD.~        2. Daily omega-3 fatty acid supplementation will reduce inflammatory protein panel scores~          in subjects at high risk for CVD.~   "
200696|NCT00935753|"~     To assess the possibility that treatment with Kuvan (a form of tetrahydrobiopterin) will~     lessen the abnormal behavior and/or neurology commonly found in Lesch-Nyhan disease (LND); to~     assess biochemical changes as measured in blood and urine.~   "
200697|NCT00935740|"~     Monocyte tissue factor (TF) was characterized in Class C heart failure (HF) vs. 25~     age-matched volunteers. TF was 2.9 fold higher (p < 0.001) in HF patients vs. controls. HF~     patients showed increased clinical events (RR=1.29, p=0.04) when comparing procoagulant~     activity above/below median. HF is associated with increased TF expression.~   "
200698|NCT00935727|"~     The study was developed to acquire images of normal, then abnormal, then unknown diagnosis~     for transplanted kidneys in order to determine whether the elastography imaging modality, a~     type of ultrasound imaging, can provide data useful for diagnosis of renal transplant~     abnormalities.~      The specific aims of this study are:~        1. To define normal elastography imaging by correlation with clinical findings.~        2. To define specific abnormal elastography images by correlation with clinical findings.~        3. To determine whether elastography could be useful in early diagnosis of abnormalities of~          renal transplants, especially in early rejection.~   "
200699|NCT00935714|"~     Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.~   "
200700|NCT00935701|"~     The purpose of this study is to see if children with autism spectrum disorder (ASD) will~     tolerate an acupressure and acupuncture intervention twice weekly over a 3 month period of~     time that targets regulatory and behavioral functions. It is anticipated that: 1) children~     with ASD will tolerate acupressure and, when properly prepared, acupuncture; 2) parents and~     children will attend bi-weekly appointments over a 3 month period; 3) parents will find~     administered acupressure technique beneficial to their child and the parent/child~     relationship; 4) parents will report lower levels of stress regarding their parenting~     experience. In addition, we will learn information about specific child regulatory and~     behavior functions (including sleep and attention) from parent and teacher reports while the~     child receives acupressure and/or acupuncture. A small clinical trial will be conducted with~     50 eligible children (3-10 years of age) with ASD (and one parent each) who will be enrolled~     into two groups: Phase 1 pre-pilot group of 10 children who will complete 8 weeks of~     treatment to help develop a treatment protocol; Phase 2 with 40 children treated for 12~     weeks. Parents and teachers will complete pre-intern and post surveys, and children who do~     not tolerate acupressure/acupuncture will be counted as treatment failures for analyses.~   "
200701|NCT00935688|"~     In areas of which are co-endemic for vivax and falciparum malaria, treatments for the two~     diseases often differ and this may lead to mistreatment. This places an emphasis on diagnosis~     at the health service provision level. Diagnosis is also important when malaris endemicity is~     low - most fevers are not caused by disease. These two issues mean that most malaria and~     fevers are not adequately treated, even though the drugs may be effective; many patients who~     do not have malaria are treated for the disease, and patients with malaria may get the wrong~     treatment for their species. The study aims to test the effectiveness of employing rapid~     diagnostic tests and will study the effect on correct treatment.~   "
200702|NCT00935675|"~     Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in~     patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and~     hypopharynx) and with an HADS total score > 11~   "
200703|NCT00935662|"~     The primary objective for this study is to assess the safety and tolerability of AZD8329 when~     given as a single dose in increasing dose strength, and also to identify the highest~     tolerated dose for future studies.~   "
200704|NCT00935649|"~     To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected~     toenails.~   "
200705|NCT00935636|"~     The purpose of this study is to collect relevant airway data using the GlideScope Cobalt~     Video Baton 1 and 2 for intubation in a large cohort of neonates and infants weighing 10 kg~     or less.~   "
200706|NCT00935623|"~     The purpose of this study is to demonstrate that volunteers can be safely and reproducibly~     infected with Plasmodium vivax (P. vivax) by the bites of experimentally infected Anopheles~     dirus (An. dirus) mosquitoes carrying P. vivax sporozoites in their salivary glands.~   "
200707|NCT00935610|"~     Aging is typically associated with a decrease in skeletal muscle mass and muscle function,~     which contributes decisively to disability in old age and to the loss of quality of~     life.Resistance exercise can increase muscle strength, function and mass in older adults.~      The primary aim of this study is to determine whether the combination of resistance training~     with a supplementation of a cysteine- rich whey protein isolate (Immunocal) compared to~     combination of resistance training with casein used as control (casein contains little~     cysteine) could have the potential to provide a synergic beneficial impact on muscle mass and~     function which could translate to an improved quality of life in elderly persons.~   "
200708|NCT00935597|"~     The purpose of this study is to assess preliminary efficacy and to determine the safety and~     feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor~     lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). We also wish to~     establish the feasibility of apheresis shipment as well as vaccine shipment and stability in~     the population.~   "
200709|NCT00935584|"~     The VHA is a leader in electronic medical records (EMR) use for patient care. It is believed~     that EMR use by doctors will improve patient-centeredness of visits, and improve clinical~     care. The proposed study will determine how doctors should use the EMR during patient~     consultations. We will also develop a training program to improve doctors ability to~     communicate with patients while using EMR.~   "
200712|NCT00935545|"~     This is an open-label, single arm study evaluating a multi-peptide (tumor-associated~     antigens)/Montanide vaccine in patients < 21 years of age with recurrent or refractory CNS~     tumors. The study primarily evaluates the safety of this regimen. Secondarily, immunogenicity~     and anti-tumor effects will be assessed.~      The primary aim is to evaluate the safety of subcutaneous injections of tumor associated~     antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain~     tumors.~      The secondary aims are to evaluate cellular immune responses induced in patients after~     subcutaneous injection of TAA mixed with Montanide ISA-51VG and to document tumor response in~     patients with measurable disease or time to progression in patients without measurable~     disease following subcutaneous injection of TAA mixed with Montanide ISA-51VG.~   "
200713|NCT00935532|"~     The objectives of this clinical trial are to compare the effects of exenatide once weekly and~     insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.~   "
200714|NCT00935519|"~     This study will evaluate a midterm clinical and radiologic outcome patients who undergo new~     alumina-zirconia composite ceramic bearing THA.~   "
200715|NCT00935506|"~     Purpose of study is to evaluate a thrombosis chamber model~   "
200716|NCT00935493|"~     This proposal aims to determine whether low does of the alpha-2A-adrenoceptor agonist~     guanfacine can improve deficits in prefrontally-mediated cognitive functions in healthy~     elderly subjects.~   "
200717|NCT00935480|"~     To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective~     conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors~     and one boosted protease inhibitor), on residual HIV replication and blood cell and~     gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted~     protease inhibitors: PI/r).~      To evaluate the effect of therapy intensification by means of an integrase inhibitor with or~     without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected~     with HIV-1, successfully treated with conventional triple therapy, measured by:~        -  residual plasma replication between 0 and 50 copies/ml~        -  intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in~          gut-associated rectal lymphoid tissue (RL).~        -  proviral HIV DNA levels in PBMC and RL.~   "
200718|NCT00935467|"~     To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered~     twice daily with meals to healthy subjects~   "
200719|NCT00935454|"~     This clinical investigation of the hepatocyte matrix implant is an evaluation blinded~     non-randomized and monocentric pilot study of Phase I, which is conducted as a therapeutic~     investigation. Randomization is not possible due to ethical and practical reasons. Pending~     approval of the ethical committee the study will also be conducted in Indonesia.~      This new treatment procedure has already been successfully used on the basis of compassionate~     use in Germany. The hepatocyte matrix implant is a new patented procedure consisting of~     bio-matrix technology. A formaldehyde-free special matrix consisting of self-dissolving~     polymers is applied as a carrier substance and is cultivated with human autologous cells~     using a special technique. Clinically the bioartificial liver replacement tissue for patients~     with end-stage hepatic disease has been developed as a first application. In this procedure~     autologous hepatocytic tissue and pancreatic tissue is removed (liver resection and~     pancreatic biopsy) from the patient in a first surgical procedure. The tissue is sent to a~     specialized Cell Culture Laboratory. The laboratory is GMP certified for this procedure. The~     cells are processed according to SOPs in a special perfusion procedure and prepared on~     several platelets of matrices (platelets of 20 mm diameter and 4mm thickness). After~     completion of the laboratory process the biotissues are implanted into the mesentery of the~     small intestine during a second operation. The cells are growing controlled on the matrix,~     take on the capillaries of the patient and thus connect to the blood circulation. The~     implanted cells multiply by a specific factor and independently take over the metabolic~     function of the original liver after two to four weeks. In the following process the carrier~     matrix dissolves completely and implanted cells develop into liver cell tissue.~   "
200720|NCT00935441|"~     This is a randomized trial designed to determine if adoption of the chronic care model in~     conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can~     improve glycemic control compared to patients receiving usual case management. We hypothesize~     that nurse case management, with home telemonitoring of blood sugars and home HbA1c~     measurement will result in additional improvements in glycemic control compared to isolated~     nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower~     compared to usual nurse case management. Secondary aims include an additional 5 mmHg~     improvement in systolic blood pressure (among patients with hypertension at the time of~     enrollment), improved patient satisfaction with treatment, improved medication adherence,~     reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home~     HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients~     with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for~     telephone communication. Patients will be enrolled and actively case managed for 9 months.~   "
200721|NCT00935428|"~     Horse-related activity can be risky. Horses are the leading cause of animal-related~     fatalities in Oregon and Oregon's annual death rate from animals is 45% higher than the~     national rate. By interviewing injured equestrians, the investigators may be able to~     determine patterns of decision-making and behavior from their collective experience and~     develop useful safety recommendations. The investigators will also determine the impact that~     the injury has had on quality of life. The long-term goal of the investigators research is to~     develop safety and prevention recommendations and a horse-related injury prevention program~     to reduce the number of horse related injuries.~   "
200722|NCT00935415|"~     The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic~     children by evaluating different time intervals between dosing and challenge, after a~     single-dose and after three days of once a day MNT administration.~   "
200723|NCT00935402|"~     Observational and epidemiological studies have found a link between obesity and short sleep~     duration with the prevalence of both increasing in the past decades. At this time, it is~     unknown whether short sleep is a cause of obesity and how short sleep would lead to obesity.~     Some studies associate short sleep with increased levels of hormone that stimulate appetite.~     This study will examine how food intake and energy expenditure can be modified by sleep~     duration as a means of understanding a potential causal pathway.~   "
200724|NCT00935389|"~     The purpose of this study is to analyze the clinical effects and adverse reactions of~     tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.~   "
200725|NCT00935376|"~     The pilot project will investigate three short-term intervention programs for sleep~     management in cancer survivors in a randomized controlled clinical study. Three programs to~     be examined in the study are:~        1. the mind-body bridging program (MBBP),~        2. mindfulness meditation program (MMP), and~        3. sleep education program (SEP).~   "
200728|NCT00935337|"~     The first part of the pilot study, as detailed in Unique Protocol ID No. 27522, is a~     randomized clinical trial that compares the effects of a mind-body bridging program with a~     sleep hygiene program to improve sleep quality in patients suffering from sleep disturbances.~     In Part II of the study, the investigators will perform a six month follow-up on the same~     subjects.~   "
200729|NCT00935324|"~     Prospective, within-subject controlled study on multiple subject groups to evaluate the~     meaning of CK18-fragments in the diagnosis, biological activity and prognosis of~     graft-versus-host disease (GvHD). Groups consist of patients scheduled for allogenic stem~     cell transplantation (allo-SCT) (Group A) and healthy voluntary blood donors (Group B).~   "
200730|NCT00935311|"~     The purpose of this study was to evaluate analgesic efficacy and safety of~     hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar~     extraction.~   "
200731|NCT00935298|"~     Acute rejection (AR) is the main complication after transplantation, which is a severe risk~     of chronic rejection and implant devitalization.~      Tacrolimus (FK506) is an immunosuppressant used for the prevention of episodes of acute~     rejection. Tacrolimus is characterized by a narrow therapeutic index and important~     interindividual variations of its pharmacokinetic characteristics.~      Tacrolimus is metabolized through the liver by the cytochrome P450 system, the cytochrome~     P450 3A5 (CYP 3A5) isoenzyme specifically. Polymorphisms in the CYP 3A5 gene have been~     associated with changes in metabolic function of the translated isoenzyme. These~     polymorphisms result in metabolism acceleration of tacrolimus as compared to subjects having~     the wild type gene, consequently leading to insufficiency of tacrolimus; it is theorized that~     this leads to higher risk of acute rejection. Several retrospective studies suggested an~     association between a genetic polymorphism of CYP3A5 and the interindividual variations of~     tacrolimus blood concentration. In particular, our initial study showed that adult renal~     transplant recipients with the CYP3A5*1/*3 and *1/*1 （expressors） genotype require higher,~     fixed, starting dose compared with CYP3A5*3/*3 （nonexpressor）to reach the predefined target~     exposure early after transplantation.~      This prospective study is designed to evaluate whether genetic testing of CYP 3A5 can improve~     tacrolimus initiation better than usual care. This study is a prospective, multicentric,~     open, parallel , efficacy study. 300 receivers of a renal transplant in 8 centres will be~     included.~      The genotyping of gene CYP3A5 will be carried out in the 4-7days before renal~     transplantation. After transplantation, the patients will be treated by MMF, corticosteroids~     and tacrolimus at a dosage adapted to their genotype(0.15mg/kg/d for CYP3A5*1/*1 type and~     CYP3A5*1/*3 type，0.08mg/kg/d for CYP3A5*3/*3 type).~      The determination of tacrolimus blood concentration will be carried out on Day~     3,5,7,14,18,21,28,35,49,63,77,90. The daily amounts of tacrolimus could be modified if~     necessary to reach the desired blood concentrations. The total duration of the study for a~     patient is 3 months after transplantation.~      The objective of this study is to determine the initial dosage of tacrolimus in Chinese renal~     transplantation patients by genotyping of the cytochrome P450 3A5~   "
200732|NCT00935285|"~     Ventilator-associated pneumonia (VAP) is very common in the intensive care unit (ICU),~     affecting 9 to 40% of ICU patients and mortality rates range from 20 to 50% and may reach~     more than 70% when the infection is caused by multi-resistant and invasive pathogens. The~     most common pathogens that cause VAP are the Gram(-) bacteria. Findings indicate that TLRs~     serves as an important signal in the generation of protective innate responses to bacterial~     pathogens of the lung and that is required for effective innate immune responses against~     Gram-negative bacterial pathogens. There is genetic evidence that mutations in TLRs increase~     the risk of developing nosocomial infections. Understanding the TLR system should offer~     invaluable opportunity for manipulating host immune responses.~   "
200733|NCT00935272|"~     To determine the safety and effectiveness of Restylane® when used for lip augmentation.~   "
200734|NCT00935259|"~     The purpose of this study was to provide human lipidomics standards with simvastatin~     treatment that were to be used for comparison with similar preclinical studies.~   "
200735|NCT00935246|"~     To reveal the genetic determinants of the treatment outcome of escitalopram in depressed~     patients (by using candidate gene approach and whole genome scanning).~   "
200736|NCT00935233|"~     RATIONALE: Studying genes in samples of blood and/or tumor tissue from patients with cancer~     may help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at blood and/or tumor tissue samples from patients~     with ductal carcinoma in situ and blood samples from healthy volunteers.~   "
200737|NCT00935220|"~     The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of~     linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of~     African American origin.~   "
200738|NCT00935207|"~     The purpose of this study is to show the impact of a pain diary on the communication of pain~     by pediatric patients. Participants will be given a pain diary after consent and asked to~     complete the record each time they have pain. A survey about the efficacy of the pain diary~     will be taken prior to discharge by the nurse, physician, patient and parents. The hypothesis~     is that the pain diary will improve the communication.~   "
200739|NCT00935194|"~     The purpose of this study is to determine whether Chinese medicinal herbs are effective and~     safe for treating novel influenza A (H1N1) infection.~   "
200740|NCT00935181|"~     Objective: The investigators studied the effects of respiratory muscle stretching in an~     8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled~     trial, conducted an out-patient clinic. Twenty six patients with COPD (mean age 68 ± 6 y,~     percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching~     group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise~     program that had 3 sessions per week. The investigators measured inspiratory and expiratory~     muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise~     capacity (by 6-minute walk distance), dyspnea and quality of life.~   "
200741|NCT00935168|"~     The aim of this study is to determine whether patients in the Intensive Care Unit who receive~     fluid resuscitation with either hydroxyethyl starch (a synthetic colloid solution) or saline~     (a salt solution), have an increased rate of survival at 90 days.~   "
200742|NCT00935155|"~     No randomized trials have tested the effectiveness of acupuncture as a supplement to~     rehabilitation after total knee replacement. Studies from related fields, however, have shown~     reduction of symptoms as a result of acupuncture treatment in patients with knee pain caused~     by severe osteoarthritis in the knee. Furthermore, studies have reported that the need of~     pain medication was lower when acupuncture treatment was performed immediately after knee~     surgery.~      The aim of this study is to test whether acupuncture can reduce pain and improve disability~     as a supplement to rehabilitation after total knee replacement.~      One hundred and seventy patients will be allocated by drawing lots to either a treatment~     group receiving exercise therapy and acupuncture or a group receiving exercise therapy alone.~     Treatment will start 3 weeks after surgery at the latest.~      Outcome of treatments will be measured at completion of treatment and at 3 months follow-up~     by pain- and disability questionnaires as well as the recording of walking capacity.~   "
249697|NCT00284102|"~     The investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on~     gas exchange.~   "
200743|NCT00935142|"~     The purpose of this study is to determine the toxicity of the hypoxia PET-tracer~     [18F]-VM4-037 in cancer patients in two dose-steps:~        -  Step 1 (3-6 patients): a single dose of maximum 8 mCi (296 MBq) dose of [18F]VM4-037 via~          a bolus IV injection.~        -  Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of [18F]VM4-037~          via a bolus IV injection~   "
200744|NCT00935129|"~     Randomized, two arms, open study in order to evaluate treatment satisfaction of using OmniPod~     system compared with conventional insulin pump in adults with type 1 diabetes.~      The study will include two consecutive 12 weeks treatment periods. According to~     randomization, each patient will be treated consecutively with both treatment arms: 12 weeks~     with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.~   "
200745|NCT00935116|"~     The purpose of the study is evaluate the analgesic efficacy and safety profile of the Cox-2~     specific analgesic Etoricoxib (arcoxia®) when administrated pre and postoperatively for~     controlling pain in adult patients undergoing thyroid surgery. Patients will be followed up~     in the immediate postoperative period, during the first postoperative (POD) day and in POD 2,~     3 and 7. It is expected that with the addition of Etoricoxib, patients will experience less~     pain during the overall postoperative period and also a better quality of recovery when~     compared with the traditional analgesic regimen.~   "
200746|NCT00935103|"~     The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug abuser for reducing high-risk~     behavior~   "
200747|NCT00935090|"~     RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) PET~     imaging, may help find and diagnose cancer. It may also help doctors predict a patient's~     response to treatment and help plan the best treatment.~      PURPOSE: This phase I trial is studying FLT PET imaging in patients with cancer.~   "
200748|NCT00935077|"~     The purpose of the study is to determine the degree to which pharmacist-physician~     collaborative management (PPCM) of hypertension can be adopted and implemented in clinics~     with geographic and racial diversity and whether patients in clinics which implement PPCM~     achieve greater blood pressure control than patients in clinics which do not implement PPCM.~      Primary Hypothesis: BP control at 9 months will be significantly greater in patients from~     clinics randomized to the two PPCM BP intervention groups compared to the control group.~   "
200749|NCT00935064|"~     This study will assess the effect of direct renin inhibition on nerve function in persons~     with diabetes using a double-blind, placebo-controlled randomized trial involving two~     treatment arms (i.e., [1] 30 participants enrolled and randomized to 300 mg of Aliskiren; [2]~     30 participants enrolled and randomized to placebo).~   "
200750|NCT00935051|"~     The primary objective of this study is to assess the sensitivity and specificity of a~     MMP-1/TIMP-1 ratio equal to 0.24 at study entry to predict wound healing at 12 weeks' follow~     up visit.~   "
200751|NCT00935025|"~     This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending~     dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305~     extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if~     needed) dose levels will be given to Japanese subjects and one of the doses will also be~     given to Caucasian subjects.~   "
200752|NCT00935012|"~     Open-label Safety and Efficacy Evaluation of Fx-1006a in Patients with V122i Or Wild-type~     Transthyretin (ttr) Amyloid Cardiomyopathy.~      Patients who successfully complete Fx1B-201 will report to the clinical unit on Day 0 to sign~     the informed consent form and determine eligibility for Protocol Fx1B-303. In addition, on~     Day 0, patients will have their entrance criteria reviewed, and medical histories and~     demographic characteristics obtained.~      The physical examination (including weight and vital signs) and the relevant end of study~     clinical laboratory tests (alkaline phosphatase, alanine aminotransferase, aspartate~     aminotransferase, blood urea nitrogen, gamma glutamyl transferase, creatinine, total~     bilirubin, international normalized ratio, troponin I, troponin T, and amino-terminal B-type~     natriuretic peptide) from Protocol Fx1B-201 will be used for Protocol Fx1B-303. If more than~     30 days has elapsed between the final study visit of Protocol Fx1B-201 and Day 0 of Protocol~     Fx1B-303, an abbreviated physical examination (including weight and vital signs) and clinical~     laboratory assessments must be performed on Day 0.~      Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e.,~     first dose) and will return to the clinical unit for study visits every 6 months.~      Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit~     to the clinical unit. Blood draws for clinical safety laboratory tests and abbreviated~     physical examinations (including weight and vital signs) will also be performed at each~     6-month clinic visit. ECGs will be performed every 12 months on an annual basis. A telephone~     call will be made at 3-month intervals between clinic visits to assess safety and use of~     concomitant medications.~      For the evaluation of efficacy, the Patient Global Assessment, NYHA classification, KCCQ,~     6-minute walk test, and efficacy-related clinical laboratory tests (serum levels of troponin~     T, troponin I, and NT-pro-BNP) will be determined every 6 months. In addition,~     echocardiograms will be performed every 12 months on an annual basis.~      An end of study visit including all safety and efficacy assessments will occur upon patient~     completion of the study, premature withdrawal (for any reason), or in the event of program~     discontinuation by the Sponsor.~   "
200753|NCT00934999|"~     I. Specific Aims~      Pelvic organ prolapse is a common and distressing condition that is frequently associated~     with stress urinary incontinence (SUI) and often requires surgical repair. Abdominal sacral~     colpopexy is the preferred operation for repairing pelvic prolapse. As many as 91% of women~     with pelvic organ prolapse undergoing sacral colpopexy also experience SUI. In addition, up~     to 44% of previously continent women develop SUI incontinence after sacral colpopexy: perhaps~     because a sacral colpopexy may predispose to opening of the bladder neck if secured too~     tightly. The selection of a surgical procedure to prevent and manage SUI in women undergoing~     sacral colpopexy is empiric rather than evidence-based. Conceptually, a mid-urethral sling~     may be more effective than a Burch procedure for preventing urinary leakage because a sling~     provides outlet resistance beyond the bladder neck and therefore it may compensate for a~     downward tension on the bladder neck resulting from the sacral colpopexy. Indeed, clinical~     observations suggest that a mid-urethral sling is effective among women who have persistent~     urinary incontinence after sacral colpopexy with a Burch procedure. Therefore, the~     investigators' global hypothesis is that a mid-urethral sling is preferable to a Burch~     procedure for preventing and improving stress urinary incontinence in women undergoing sacral~     colpopexy for pelvic organ prolapse. The investigators' SPECIFIC AIMS are to evaluate~     objective and subjective outcomes at 6, 12 and 24 months in 124 women with urinary~     incontinence and advanced pelvic organ prolapse. All women will be undergoing a sacral~     colpopexy and will be randomized to either a Burch procedure or a mid-urethral sling. The~     primary endpoint is composite continence at 6 months while secondary endpoints will include~     composite continence and subjective measures of incontinence, patient satisfaction and~     morbidity associated with these procedures. The investigators' hypotheses are as follows:~        1. At 6 months, urinary continence rates will be higher after a mid-urethral than after a~          Burch procedure. Urine continence will be assessed by composite measure of incontinence:~          no subjective complaint, no interim treatment, and negative standardized stress test~          performed by a masked observer. This assessment will be repeated at 12 and 24 months~          post-operatively to establish the medium term continence of the two procedures.~          Subjective continence and patient satisfaction measures will be obtained at each of the~          above visits using standardized questionnaires and pelvic organ support will be~          quantified by Pelvic Organ Prolapse-Quantification (POP-Q) scores.~        2. Early events (e.g., blood loss, operative time, intra-operative complications (vascular,~          bowel and urological injuries), in-hospital complications (need for transfusion, febrile~          morbidity, thrombotic events, wound infection, length of stay, duration of bladder~          catheterization and ileus) and delayed postoperative complications (e.g., wound~          infection, mesh erosion, bowel obstruction and obstructed voiding) will be collected to~          compare the safety of each procedure.~   "
200754|NCT00934986|"~     Purpose:~      The involvement of Natural Killer cells (NK) in the efficiency of the treatment in lymphoma~     and the beginning of new therapies based on function and activation of NK, justify an~     improvement of knowledge about the status of the population of NK (number, function, genic~     expression) in Chronic Lymphocytic Leukemia (CLL).~   "
251887|NCT00254761|"~     To determine if smoking marijuana will reduce neuropathic pain without causing too much~     drowsiness or feeling too dopey.~   "
200755|NCT00934973|"~     Background:~      Irritable bowel syndrome (IBS) affects 10-22% of the United Kingdom (UK) population, with~     National Health Service (NHS) costs over £200 million a year. Abdominal pain, bloating and~     altered bowel habit affect quality of life, social functioning and time off work. Current~     general practitioner (GP) treatment relies on a positive diagnosis, reassurance, lifestyle~     advice and drug therapies, but many suffer ongoing symptoms.~      A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither~     GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are~     widely used: NHS costs 2005 of nearly £10 million for mebeverine and over £8 million for~     fiber-based bulking agents.~      Cognitive behavioral therapy (CBT) and self-management can be helpful, but poor availability~     in the NHS restricts its use. Development of web-based CBT could increase access without~     increased costs.~      Aims:~        1. To pilot an randomized, controlled trial (RCT) to assess the effectiveness of the~          commonly prescribed medications in UK general practice for IBS: mebeverine~          (anti-spasmodic) and methylcellulose (bulking-agent) and of the patient CBT based~          self-management website.~        2. To assess the level of support needed for patients using the patient CBT based~          self-management website for IBS (i.e., initial 30 minute telephone support session with~          a nurse and email support or not).~      Plan of Investigation:~      135 patients aged 16-60 years with IBS symptoms fulfilling the Rome III criteria, recruited~     via GP practices, will be randomised to: mebeverine, methylcellulose or placebo for 6 weeks~     and to the CBT based website with a nurse telephone session and email support, website with~     minimal support, or no website, thus creating 9 groups.~      Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6~     and 12 weeks. An intention to treat analysis will be undertaken by analysis of covariance~     (ANCOVA) for a factorial trial.~      Potential Impact:~      Development of a web-based self-management CBT program for IBS developed in partnership with~     patients has the potential to benefit large numbers of patients with low cost to the NHS. CBT~     has been shown to be of benefit for IBS but it's availability is limited due to the high cost~     and therapist time required for face-to-face CBT. A website can be accessed at a time and~     place convenient to the patient and the CBT program undertaken at a pace determined by~     patient needs. The website could be used as a long term support for self-management.~      Determining the effectiveness of commonly used drug treatments will help patients and doctors~     in making informed treatment decisions regarding the drug management of IBS symptoms,~     enabling better targeting of treatment to those who may benefit.~   "
200756|NCT00934960|"~     The purpose of this study is to evaluate vision at different distances (far (13 ft),~     intermediate (2.0 ft) and near (13 to 15 in)) with and without the patient's glasses (if the~     patient wears them), range of vision (the difference between the farthest distance and the~     closest distance that the patient can comfortably read 20/25 of the near card), and patient~     satisfaction (how satisfied/happy is the patient with their vision) following bilateral~     implantation of different multifocal IOLs after routine phacoemulsification.~      The patients are being asked to participate in this study because you have had cataract~     surgery and have received one of the IOLs implanted: ReSTOR +4.0 D, ReSTOR +3.0 D,~     Crystalens, and/or ReZoom. The investigator in charge of this study is Dr. Helga Sandoval.~     This study is being conducted at Storm Eye Institute at the Medical University of South~     Carolina and will involve approximately 50 volunteers.~   "
200757|NCT00934947|"~     The purpose of this study is to investigate the ability of propranolol to decrease pain and~     improve recovery in burn patients with a common genotype.~   "
200758|NCT00934934|"~     The purpose of the study is to determine whether the effect of treating Candida spp. isolated~     in the respiratory tract secretions of patients with a clinical suspicion of ventilator~     associated pneumonia (VAP) on clinical outcomes will be feasible and supported by biomarker~     data obtained.~   "
200759|NCT00934921|"~     The objective of this study was to compare the relative bioavailability of the test~     formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT~     under non-fasting conditions in healthy, non-smoking, adult subjects.~   "
200760|NCT00934908|"~     The purpose of this study is to determine if taking green tea capsules can help prevent~     weight gain in patients that start therapy with Zyprexa® (olanzapine).~   "
200761|NCT00934895|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~     Giving paclitaxel albumin-stabilized nanoparticle formulation together with everolimus may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when~     given together with paclitaxel albumin-stabilized nanoparticle formulation and to see how~     well it works in treating women with locally advanced or metastatic breast cancer.~   "
200762|NCT00934882|"~     This multi-center, open-label, non-randomized, non-placebo-controlled, Phase I study will~     define the safety profile and tumor response profile of the multi-kinase inhibitor BAY73-4506~     as oral treatment in combination with the chemotherapy regimen mFOLFOX6 or FOLFIRI in~     patients with metastatic CRC. It will also determine the impact of the combined~     administration on the concentration of drugs over time (pharmacokinetics) of BAY73-4506,~     oxaliplatin, 5 FU, and irinotecan.~      This study will be conducted at approximately 5 - 8 study centers in Germany. Up to 60~     patients will be enrolled into this study to ensute that at least 12 - 15 patients for each~     combination regimen can be evaluated for safety and pharmacokinetics. For this reason a~     minimum of 20 patients will receive mFOLFOX6 in combination with BAY73-4506 and at least 20~     patients will receive FOLFIRI in combination with BAY73-4506.~   "
200763|NCT00934869|"~     Rotational deformity or malunion causes the most significant functional deficit in these~     common fractures. The evaluation of the rotation may be performed with the~     metacarpophalangeal joints flexed although postoperative swelling may not enable this~     examination with flexion of the fingers. Furthermore, it has been shown that swelling may~     cause rotation of the digit itself. The investigators propose that the swelling may cause a~     mistake in the estimation of rotation, during surgery and early follow up period. This is of~     special importance when open reduction and rigid fixation is performed.~      Methods:~      Prospective analysis of XX isolated metacarpal fractures treated, in YY patients was~     performed. End-on view of the finger-nail was taken with a digital camera on the day of OR,~     at 2 weeks and at 1 year. The photos were taken on a standard apparatus and from a distance~     of XX cm and evaluated using ZZ software in comparison with photos taken of the other hand,~     according to the involved digit. Range of motion, type of fracture and type of fixation were~     compared.~   "
200764|NCT00934856|"~     This is an open-label, multi-center, non-randomized study of the safety and tolerability of~     the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic~     breast cancer (MBC) and of T-DM1 plus docetaxel with or without pertuzumab, for the treatment~     of participants with locally advanced breast cancer (LABC). The study comprises an initial~     dose finding (feasibility) part to determine the maximum tolerated dose (MTD) of T-DM1 and~     docetaxel, followed by an extension part aiming to consolidate the safety and efficacy of the~     recommended docetaxel/T-DM1 combination regimen.~   "
200765|NCT00934843|"~     Randomized controlled trial of the use of glucocorticoids to improve the clinical course of~     neonates post-cardiopulmonary bypass (CPB).~   "
200767|NCT00934817|"~     The pharmacokinetics of glimepiride and metformin HCl will be compared after single dose~     intake of both combinations in order to answer the following questions:~        -  Is Amaryl-M 1/500 mg (Test tablet) proportional to Amaryl-M 2/500 mg tablet with regard~          to the glimepiride component?~        -  Is Amaryl-M 1/500 mg (Test tablet) tolerable comparing with Amaryl-M 2/500 mg?~   "
200768|NCT00934804|"~     The purpose of this study is to determine the accuracy of the Galilei corneal analyzer to~     calculate the effective corneal power (keratometry, corneal curvature) in patients who have~     undergone both corneal refractive surgery and lens extraction with intraocular lens~     implantation.~   "
200769|NCT00934791|"~     The purpose of this study is to see if one kind of immunosuppressive drug has better effects~     for the patient's polycystic liver disease than another type. Tacrolimus and Sirolimus are~     the two immunosuppressive drugs that will be compared for this study. Both drugs have been~     commonly prescribed to prevent rejection.~   "
200770|NCT00934778|"~     We want to compare 2 new systems for obtaining very detailed images of the smallest airways,~     in the hope that they can be used to provide useful information about lung diseases without~     the need for invasive tests.~      Two new systems have been developed for use down the bronchoscope, which provide video~     imaging of the smallest airways, each system looking at a different aspect of the structure~     of the airway walls. In principal, this method could provide useful information which may~     reduce the need for a surgical lung biopsy. We will therefore be assessing the value of the~     additional information obtained with these two new systems.~      The purpose of this research project is to gather information using both systems to gain a~     greater understanding of the tissue characteristics of various diseases without the need for~     a biopsy.~   "
200771|NCT00934765|"~     Obesity has been found to be a risk factor for female infertility. Studies have indicated~     that obese men often have poor semen quality and require increased time to make partner~     pregnant. To date, no studies have investigated the effect of weight reduction on male~     fertility. The purpose of this study is to investigate the effect of weight reduction in~     overweight and obese men on their reproductive function.~   "
200772|NCT00934752|"~     The study will enroll patients with angiographically significant coronary de novo lesions.~     Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after~     bare-metal stenting (BMS). The purpose is to assess the feasibility, safety and efficacy of~     the Lutonix Catheter for treatment of de novo coronary artery stenosis using two distinct~     treatment strategies.~   "
200773|NCT00934739|"~     Objectives:~        1. To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk~          oral cavity cancer patients after curative local treatment.~        2. To study the toxicity and compliance of post-operative anti-angiogenesis therapy~      Study design:~      This is a multi-center randomized controlled phase II/III two-stage study.~      Study endpoints:~      The primary endpoint is the tumor-free survival (primary and second primary malignancies) and~     the primary analysis is to compare the tumor-free survival between groups.~   "
200774|NCT00934726|"~     Since subjective well-being and quality of life (QoL) are increasingly being recognized as~     important treatment outcomes in patients with schizophrenia (Hofer et al., 2004; Becker et~     al., 2005), the aim of this study is to investigate the effect of treatment with quetiapine~     XR on these parameters in the acute hospital and the subsequent ambulant care setting. The~     study is planned to be conducted in 15 centers all over Austria and, overall, about 150~     inpatients with a ICD-10 diagnosis of acute schizophrenia are planning to be enrolled. The~     duration of the whole trial will be approximately 4 months, whereas 2 visits during~     hospitalization and two further visits after discharge will be scheduled. At each visit,~     adverse events and safety parameters, patient satisfaction and effectiveness of the current~     treatment, as well as concomitant medication and dosing schedules will be assessed and~     documented.In addition to that, the patients' overall satisfaction with antipsychotic therapy~     and their current quality of life will be determined using a QoL questionnaire, focussing on~     the subjective experience with quetiapine XR.~   "
200775|NCT00934713|"~     The study is designed to evaluate the efficacy of montelukast on symptom-free days in~     unselected group of very young children with wheeze and recurrent asthma like symptoms. The~     secondary aim was to evaluate the effect of montelukast on lung function, airway~     responsiveness, airway inflammation and use of rescue medication.~   "
200776|NCT00934700|"~     This is a randomised controlled trial in newborn infants with perinatal asphyxial~     encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve~     cerebral metabolism and structure.~   "
200777|NCT00934687|"~     Depression is frequently accompanied by a specific sad facial expression. This expression is~     in part mediated by the same muscle activity that produces frown lines. Based on the~     assumption that there is a positive feedback between depressed mood and the correspondent~     facial muscle activity (facial feedback) the investigators will conduct a randomized~     controlled pilot study in which the investigators will apply a classical cosmetic treatment~     of frown lines with injections of botulinum toxin to depressed patients who did not~     sufficiently respond to antidepressant medication. The investigators hypothesize that this~     treatment will contribute to the amelioration of depressive symptoms in these patients. This~     hypothesis is supported by a previous open case series in which remission of depression was~     reported after such treatment (Finzi and Wasserman, 2006).~   "
200778|NCT00934674|"~     This study is comparing 2 formulations of bosutinib in healthy subjects.~   "
200779|NCT00934661|"~     At Wake Forest University, the investigators have been using Extended Release Epidural~     Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having~     gynecologic surgeries and hip arthroplasties.~      Hypothesis:~      In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in~     conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in~     increasing proportion of patients who meet discharge criteria within 24 hours.~   "
200780|NCT00934648|"~     This study will evaluate the safety and efficacy of MabThera in patients with active~     rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with~     methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on~     days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly).~     After the initial study period of 24 weeks, eligible patients may receive up to 3~     re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the~     target sample size is <100 individuals.~   "
200781|NCT00934635|"~     The primary objective of this study is to compare the effect of two different antipsychotic~     compounds which are used in the treatment of schizophrenia (paliperidone ER and risperidone)~     at their target sites in two specific areas of the brain in patients with schizophrenia. A~     specialized X-ray known as Positron Emission Tomography (PET) Imaging is used to assess the~     areas of the brain targeted by both compounds.~   "
200782|NCT00934622|"~     This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed~     pre-operatively, and at subsequent visits (following the implantation of the intraocular lens~     in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.~   "
200783|NCT00934609|"~     The study investigates the safety and effectiveness of a 12 week endurance training program~     for patients with chronic heart failure~   "
200784|NCT00934596|"~     To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing~     technique) can shorten the left heart de-airing time and prevent or minimize cerebral air~     emboli during open surgery involving exposure of the left heart to the ambient air.~      To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique~     compared to Lund de-airing technique.~   "
200785|NCT00934583|"~     This study will examine the ability of an Internet-based program to prevent college-aged~     women from developing eating disorders.~   "
200786|NCT00934570|"~     The purpose of this study is to assess the sustainability of a two-year intervention aimed at~     improving body mass index (BMI) and metabolic and vascular health in obese youth. The study~     will compare lifestyle changes with diet and exercise alone with changes in lifestyle in~     combination with metformin medication. An initial intensive exercise program will also be~     compared with a standard exercise program.~      Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese~     children and adolescents will be associated with reduced rate of weight gain, improved BMI,~     body composition, physical activity, physical fitness, insulin sensitivity, blood lipid~     profiles, adipocytokines and vascular function.~   "
200787|NCT00934557|"~     Paediatric patients affected by haematological malignancies and eligible to undergo HSCT from~     an unrelated volunteer will be stratified according to the degree of compatibility with their~     donor, the source of haematopoietic stem cells employed (BM vs. PB) and the disease phase~     (good vs. poor prognosis). In particular, on the basis of compatibility with their donor,~     patients will be allocated to 2 different arms: those transplanted from an unrelated donor~     either perfectly matched or with a single allelic disparity at one of the HLA loci (i.e. A,~     B, C, and DrB1) vs. those transplanted from an unrelated donor either with 2 allelic~     disparities or with an antigenic disparity at the HLA loci (i.e. A, B, C, and DrB1).~      Patients enrolled in the study will be randomized to receive ATG (Fresenius) at a dosage of~     either 30 mg/Kg (10 mg/Kg on days -4, -3 and -2) or 15 mg/Kg (5 mg/Kg on days -4, -3 and -2).~      Good prognosis patients are defined as follows: ALL in 1st CR; ALL in 2nd CR belonging to S2~     group; AML in 1st CR, AML in 2nd CR and relapsed more than 6 months after stopping therapy;~     NHL in 2nd CR; Ph+ CML in 1st CP; refractory cytopenia.~      Poor prognosis patients are defined as follows: ALL in 2nd CR belonging to the S3-S4 group;~     ALL in ≥ 3rd CR; AML in 2nd CR and relapsed less than 6 months after stop therapy; secondary~     AML; NHL in 3rd CR; Ph+ CML in 2nd CP, as well as in AP; RAEB, RAEB-t, JMML.~   "
200788|NCT00934544|"~     This is an open label, randomized study comparing the efficacy and safety of randomized 2:1~     INC424/INCB018424 tablets versus best-available therapy, as selected by the investigator. The~     purpose is to compare the efficacy, safety and tolerability of INC424/INCB018424 given twice~     daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post~     polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis~     (PET-MF).~   "
200789|NCT00934531|"~     Compared with cognitively normal older adults, those with mild cognitive problems (MCI) have~     a two-fold higher rate of falls, sustain more fractures, and have a higher rate of mortality~     due to falls. Why older adults with cognitive problems fall more frequently is not completely~     understood. What is known, however, is that attention is a necessary cognitive resource for~     normal walking and impairments in attention are associated with increased risk of falls in~     older adults.~      It has been suggested that cholinesterase inhibitors (ChEI), medications used for treatment~     of dementia, may improve motor function and walking (gait performance). Since ChEI are known~     to improve attention, we hypothesized that ChEI will reduce falls risk in people with MCI by~     improving their gait velocity, improving their balance, and reducing their gait variability;~     a well-established risk factor for falls.~      In the proposed study, we will evaluate the effect of donepezil (ChEI) on gait velocity, gait~     variability, and the balance on 140 elderly individuals with MCI (70 intervention and 70~     controls). Gait variables will be measured using an electronic walkway, and balance~     confidence using a validated scale (Activities-Specific Balance Confidence Scale; ABC) over~     four months.~      By characterizing and understanding the effects of cognitive enhancers on fall risk in older~     adults with cognitive impairments, we will be able to pave the way for a new approach to fall~     prevention in this population. We would establish that medications that augment cognitive~     function could be a complementary therapeutic option for reducing fall risk in people with~     MCI. This may lead to new approaches to prevent and treat fall risk in this population, which~     will lead to improve the autonomy and quality of life of seniors in early stage of dementia,~     and a decreased burden for the Ontario health care system.~   "
200790|NCT00934518|"~     The standard treatment for head and neck cancer relapses in previously irradiated patients is~     controversial. Reirradiation has had some success, but many patients still die from their~     disease. Cetuximab is helpful in relapsed head and neck cancer, and it improves the~     effectiveness of radiation in some head and neck cancer patients. But, it has not been~     studied with reirradiation. The purpose of this study is to see the effects, both good and~     bad, of reirradiation with cetuximab.~   "
200791|NCT00934505|"~     The poor prognosis in the early-stage of oesophageal carcinoma cancer is due to potential~     worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity~     of actual treatments.~      FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose~     consumption. Then, this exam is used for pathology staging, target volume definition for RT,~     and treatment efficiency few months after CRT. Our assumption is that an FDG-PET exam during~     the course of CRT might be predictive of the treatment efficiency few months later.~      In this study, we propose to perform 4 FDG-PET: first PET1 before chemo-radiotherapy,~     second PET2 during the chemo-radiotherapy (see RTEP1), third and fourth PET3 PET4~     3month and 12 month after the end of radiotherapy.~      We will investigate the performances of FDG-PET performed during CRT for the prediction of~     the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, we would be~     able to optimize the planning treatment during the course of the therapy.~   "
200828|NCT00934024|"~     The purpose of this study is to evaluate the impact of varenicline treatment on cue induced~     craving to smoking using brain imaging. The investigators hypothesize that participants will~     report reduced urges to smoke and will have less activation in parts of the brain associated~     with craving.~   "
200792|NCT00934492|"~     This trial aims to test the hypothesis that mortality among Kenyan children with severe~     malnutrition following initial stabilisation is due to ongoing vulnerability to infectious~     disease, and that long term daily co-trimoxazole prophylaxis will reduce mortality.~      The objective is to conduct a randomized, double blind, placebo-controlled trial of~     cotrimoxazole prophylaxis for 6 months among HIV-uninfected children with severe malnutrition~     following stabilization. The primary outcome will be survival at one year. Secondary outcomes~     are toxicity, growth, the frequency and causes of hospitalisation and microbial resistance to~     antibiotics.~      Cotrimoxazole has striking protective efficacy against mortality among children with HIV,~     despite not altering the underlying immune deficiency. It is hypothesised that co-trimoxazole~     prophylaxis will have a similar effect in children immunocompromised because of severe~     malnutrition. Worldwide, severe malnutrition is commoner than HIV in childhood and~     co-trimoxazole is cheap and widely available, making it easily translatable to policy.~   "
200793|NCT00934479|"~     The purpose of this study is to determine whether the bacteria normally present in the bowels~     are different in people with constipation and to see what effect the treatment with the Food~     and Drug Administration (FDA) - approved drug, lubiprostone, has on these bacteria.~   "
200794|NCT00934466|"~     This study will assess transcranial magnetic stimulation (TMS) as a biomarker and~     characterize TMS readouts of the activity of MK2637 and dextromethorphan. Resting~     quantitative electroencephalography(qEEG) readouts are also characterized with MK2637 and~     dextromethorphan.~   "
200795|NCT00934453|"~     This study is a single site, Phase I, masked, randomized study to evaluate the safety and~     tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy~     adult volunteers. Study drug capsules (1x10^10 LGG/capsule or placebo) will be taken by mouth~     twice a day with cow's milk or soy milk on an outpatient basis. Volunteers will have study~     visits at baseline, 1 month, 3 months, 6 months, 7 months, and 12 months where they will be~     asked about any medical problems that have come up since the last study visit, have vital~     signs taken, review current medication use, and review any signs of potential adverse events.~     Blood and urine samples will also be collected at these visits, as well as throat and stool~     samples.~      Our goal is to assess the safety and tolerability of LGG when administered to healthy adult~     volunteers twice a day. Assessment of safety will be determined by vital sign measurements,~     physical examinations, clinical laboratory tests, and from the incidence and severity of~     adverse events that occur during study participation. Additionally, we will assess whether~     LGG colonizes the throat and/or gastrointestinal tract of healthy adult volunteers and assess~     the effect of LGG on the bacteria that normally live in the throat and GI tract by using~     culture-independent techniques. Volunteers enrolled in this study will also be invited to~     participate in a companion genetic study that will investigate the host immune response to~     the bacteria in LGG.~   "
200796|NCT00934440|"~     To identify the maximum tolerable dose and assess qualitative/quantitative toxicities in~     patients with advanced renal cell cancer treated with combination of 5-azacitidine and~     bevacizumab.~   "
200797|NCT00934427|"~     The purpose of this study is to determine if Vascana, a novel topical formulation of~     nitroglycerin, is effective in the treatment and prevention of the symptoms associated with~     Raynaud's Phenomenon.~   "
200798|NCT00934414|"~     Twelve smoking and twelve non-smoking subjects with Type 2 Diabetes Mellitus will be enrolled~     in this study to determine the effect of Technosphere® Insulin Inhalation Powder on insulin~     in the body during a clamp procedure.~   "
200799|NCT00934401|"~     Positron Emission Tomography Imaging with 3-Deoxy-3'-[18F]Fluorothymidine (FLT) can~     selectively identify proliferating and non-proliferating tissues, including tumors. FLT~     uptake in the tumor is an indirect marker of DNA synthesis activity, which is a target of~     chemotherapy. Our hypothesis is that early change in FLT uptake in tumor with chemotherapy~     will predict pathological response to neoadjuvant therapy in breast cancer. Tumor uptake of~     FLT will be imaged and measured with positron emission mammography (PEM), a PET scanner~     optimized for breast imaging with a significantly improved resolution compared to~     conventional whole-body PET imaging systems.~   "
200800|NCT00934388|"~     Chronic groin pain is a frequent cause for referral to general surgeons. In some cases this~     pain may be due to the presence of a hernia. However, if on clinical examination there is no~     palpable lump or bulge, the cause of the pain may be difficult to elucidate. Some of these~     patients may have the diagnosis of sportsman's groin. Other names which have been attached to~     this condition include Gilmores groin and sportsmans hernia. These conditions are more~     commonly associated with sportsmen and women but those who do not play sport may also receive~     this diagnosis. Sportsman's groin is thought to be a syndrome of weakness of the posterior~     inguinal wall without a clinically recognisable hernia. Differing explanations for~     sportsman's groin include avulsion of the conjoint tendon from the pubic tubercle, weakening~     of the transversalis fascia, tears in the internal or external oblique, superficial inguinal~     ring dilatation and abnormalities of the rectus abdominus insertion.~      There is some evidence that pre peritoneal mesh placement in these patients may be~     beneficial. The theory being that the mesh prevents pressure transmission to the damages~     structures, allowing them to heal more rapidly.~      Aim. To assess the potential benefit of pre peritoneal mesh placement using the TAPP~     technique in patients with chronic groin pain.~   "
200801|NCT00934375|"~     This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive~     Impairment who have completed the double-blind study (E2020-A001-412).~   "
200802|NCT00934362|"~     Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive~     forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve~     lung health. The investigators propose to measure mucus clearance before and after~     lucinactant or vehicle administration in patients with cystic fibrosis.~   "
200803|NCT00934349|"~     The purpose of this study is to assess the existence of a genetic factor, suspected to be~     involved, aside from likely food deficiency contribution, in occurrence of dry beriberi, in~     patients who experienced dry beriberi and in a case group composed of 3 people, free from~     beriberi, within the same household.~   "
200829|NCT00934011|"~     In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT)~     - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and~     septic shock. Therefore, the safety of this intervention will be carefully measured.~   "
200804|NCT00934336|"~     The aim of this study is to determine whether postprandial hyperglycaemia plays an important~     role in oxidative stress phenomena and influences their harmful effects on the arterial wall.~      25 type 1 diabetic patients practicing FIT and with an HbA1c value of 8 percent or less at~     the beginning of the study will be recruited. The 25 control subjects will be recruited after~     the patients, so that they can be paired by age and sex.~      Patients will be randomized via an alternative cross over study design for 2 periods of 3~     months, i.e. preprandial or postprandial injection of an ultra fast acting analog. During the~     6 months of the study, slow acting analog doses will be adjusted on the basis of basal~     glycaemia values. The fast acting analog doses will be adjusted on the basis of an optimized~     algorithm available on each patient's PDA phone electronic diary.~      Blood and urine samples will be collected at M0, M3 and M6 to evaluate the stress oxidant~     grade and its consequence on atherogenesis:~      Oxidative Stress evaluation: plasma parameters (lipid peroxide derivatives, semicarbazide~     sensitive oxidase amine activity), erythrocyte and leukocyte cell parameters (reduced and~     oxidised glutathion, dismutase superoxide activity (SOD) Cu and Mn dependent, glutathion~     peroxidase, and catalase), urinary parameters (isoprostane F2) Evaluation of consequences of~     oxidative stress on atherogenesis processes: inflammatory parameters (CRP, TNFa, IL 6),~     adhesion molecules (VCAM 1, ICAM 1, P selectine), adipokines (leptine, resistine,~     adiponectine), coagulation factors (PAI 1), platelet and endothelial microparticles, The pre~     and postprandial glycaemic stability of each patient will be monitored using PDA phone~     systems, and HbA1c will be measured at M0, M3 and M6.~      Expected results and outcomes:~      It is important to know if, in patients with comparable glycaemic stability, these two~     insulin treatment regimens are associated with significant differences in oxidative stress~     and anti oxidant defenses.~      These results may help us to define a postprandial insulin treatment regimen (which is more~     flexible as regards meals) or a preprandial insulin treatment regimen (less flexible for~     meals but maybe less harmful in terms of limitation of oxidative stress).~   "
200805|NCT00934323|"~     The pharmacokinetics of glimepiride and metformin will be compared after single dose intake~     of both combinations in order to answer to the following questions:~        -  Is there a dose proportionality effect between Amaryl M SR 1/500 mg and Amaryl M SR~          2/500 mg?~        -  What is the safety profile of Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?~   "
200806|NCT00934310|"~     In January of 2007, the World Health Organization's (WHO) World Alliance for Patient Safety~     initiated a project called Safe Surgery Saves Lives to identify minimum standards of~     surgical care that can be universally applied across countries and settings. Through a two~     year process involving international input from surgeons, anesthesiologists, nurses,~     infectious disease specialists, epidemiologists and others, the WHO created a surgical safety~     checklist that encompasses a simple set of surgical safety standards that can be used in any~     surgical setting. Each safety step on the checklist is simple, widely applicable, and~     measurable. The Surgical Safety Checklist was piloted in 8 hospitals around the world and~     results demonstrated a significant decrease in death rate and postoperative complications.~      This study proposes to introduce an adaptation of the Surgical Safety Checklist for an~     ambulatory care surgical program and to assess the efficacy of its adaptation and~     implementation on staff safety attitudes and patient outcomes. Specific ambulatory-based~     items will be included in the checklist and patient outcomes will be assessed using the~     Institute for Health Improvement's Perioperative Surgical Outcomes Tool which will also be~     adapted for use for the ambulatory setting as well as routine follow up phone calls with~     patients on the 1st postoperative day.~   "
200807|NCT00934297|"~     Magnetic resonance imaging (MRI) is commonly used for the detection of breast lesions in~     genetically high-risk women due to its high sensitivity. As non-cancerous conditions~     including normal changes due to a woman's menstrual cycle may have the appearance of cancer~     on MR images, a biopsy (generally performed under ultrasound-guidance) of the suspicious mass~     is required for definitive diagnosis. However, only a limited percentage of MRI-visible~     lesions are also visible on ultrasound (US). Even if found, it is often unclear whether the~     lesion identified on US corresponds to the MRI-detected lesion in question. The investigators~     have developed a visualization tool to assist the visualization of MRI-detected lesions in~     US-guided procedures (e.g., biopsy). This tool provides a simultaneous display of the~     previously acquired MRI data alongside real-time US images. The investigators propose a pilot~     study to assess the usefulness of this tool in identifying MRI-detected lesions using~     real-time US-guidance.~   "
200808|NCT00934284|"~     The purpose of this study is to determine if participation in physical therapy in conjunction~     with a selective nerve root block in the lumbar spine is more effective than just receiving~     the injection alone for patients with low back and leg pain from a disk herniation~     (sciatica).~   "
200809|NCT00934271|"~     Hypothesis: Fractionated stereotactic radiotherapy is a safe therapy for treatment of~     patients with acromegaly in terms of both tumour control and biochemical remission~   "
200810|NCT00934258|"~     Previous studies indicate that the variant status of detoxification proteins is different~     among Taiwanese and other ethnic groups. For example, in Taiwanese, the major SNPs of CYP2C9~     are CYP2C9*2 (430C>T) and CYP2C9*3 (1075A>C) and their frequencies are different from that in~     Caucasians [11]. The second example is that the frequency of the A(TA)7TAA allele in the~     promoter area of the UGT1A1 gene is substantially lower, while for the rate of variation~     within the coding region is much higher in Taiwanese than that in Caucasians (14.3% vs. 35.7-~     41.5% and 29.3% vs. 0.1%, respectively) [12]. The third example is that the frequency of~     388A>G of the OATP2 gene in Taiwanese (0.68) [13] is in between that in European Americans~     (0.30) and African Americans (0.74) [14]. Therefore, the investigators hypothesize that, in~     Taiwanese the SNPs of detoxification proteins modulate the lipid-lowing effects of RVA and~     fenofibrate may be different from those for Caucasians.~   "
200811|NCT00934245|"~     The study described here will immunize children with trivalent influenza vaccine (TIV) and~     determine whether this reduces influenza illness among the immunized children and their older~     family members. The comparison or control group for the children receiving influenza vaccine~     will be children immunized with inactivated poliovirus vaccine (IPV). The study will also~     provide information on the amount of disease produced by influenza in the study population.~   "
200812|NCT00934232|"~     Two main objectives of the study are:~      Primary:~      To determine the MTD of Busulfex ® that can be given safely over the least number of days to~     myeloma patients who are either ≥65 years of age (Group 1) or have renal insufficiency (Group~     2), defined as creatinine >3mg/dL or creatinine clearance <30 mL/min.~      Secondary:~      To perform pharmacokinetic (PK) studies to evaluate individual variability and the~     relationship to toxicities in each of the two groups at each proposed dose level.~   "
200813|NCT00934219|"~     Lovaza is a special fish oil concentrate, that prescribed at 4 g a day to reduce certain fat~     (triglycerides) levels in blood.Our goal is to study how Lovaza at doses of 4, 8, and 12~     grams per day will reduce fats in the blood of the patients with very high level of~     triglycerides. Our hypothesis is that patients with very high triglycerides will respond more~     with higher doses of Lovaza (8 g per day and then 12 g per day).~   "
200814|NCT00934206|"~     Physical exercise elicits beneficial changes in the body. These concern physical performance~     but also improvements in virtually all known risk factors for cardiovascular disease. Yet,~     the extent of individual benefit differs considerably even within homogenous groups and the~     prediction of individual training effectiveness is not yet possible. This study aims to find~     predictors of individual training effectiveness.~   "
200815|NCT00934193|"~     The primary objective of this study is to determine if gabapentin can decrease or prevent~     chronic post-thoracotomy pain.~   "
200816|NCT00934180|"~     The objective of this study was to compare the relative bioavailability of the test~     formulation of Ondansetron HCl with the already marketed reference formulation Zofran ODT~     under fasting conditions in healthy, non-smoking adult subjects.~   "
200817|NCT00934167|"~     The aim of this study is to verify, through clinical examination and doppler, the~     non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to~     the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous~     thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of~     this pathology.~   "
200818|NCT00934154|"~     This is a multi-centre Phase III randomized controlled study of patients with multiple~     myeloma (MM). Eligible patients who are not candidates for transplantation will be randomized~     to receive eight courses of Melphalan/Prednisolone with or without Thalidomide treatment.~     Thalidomide will be initiated at the dose of 100 mg/day and maintained at 100 mg/day. The~     patients will be assessed for any responses at the end of 2nd, 4th, 6th and 8th cycles of~     treatment. The toxicities will be assessed at monthly intervals. Patients will be assessed~     for the:~        1. Incidence and grade of any toxicity~        2. Level of maximum disease response~        3. Time to disease progression~        4. Time to death~   "
200819|NCT00934141|"~     Addiction treatment is often characterized by long delays between first contact and treatment~     as well as high no-show and drop out rates leading to unused capacity in apparently full~     agencies. Patients do not get needed care and agency financial stability is threatened. The~     Network for Improvement of Addiction Treatment (NIATx) began as a high-intensity improvement~     collaborative of 39 addiction treatment agencies distributed across 25 states. NIATx~     substantially improved time to treatment and continuation in treatment by making improvements~     to organizational processes (such as first contact, intake and assessment, engagement, level~     of care transitions, paperwork, social support, outreach, and scheduling) in preliminary~     studies. While the results are very encouraging, they have, by intent, been obtained from a~     select group of agencies using a high-cost combination of services. A more practical~     diffusion model is needed to spread process improvements across the spectrum of treatment~     agencies. This study is a cluster-randomized trial to test the effectiveness and cost of less~     expensive combinations of the services that make up the NIATx collaborative (interest~     circles, coach calls, coach visits and learning sessions).~   "
200820|NCT00934128|"~     The goal of this clinical research study is to learn if specialized breathing devices reduce~     the sensation of shortness of breath in patients with advanced cancer who are experiencing~     shortness of breath. Researchers want to learn if these devices can help to control shortness~     of breath.~      The 2 devices being tested and compared are called BiPAP (bilevel positive airway pressure)~     and Vapotherm.~   "
200821|NCT00934115|"~     Infections are common causes of morbidity and mortality in pediatric cancer patients. Today,~     there are limited data on the incidence, distribution of specific infections, causative~     agents and risk factors for severe infections in this population. Moreover, little data exist~     on the epidemiology of infections among pediatric patients with solid tumors.~      The objectives of the present study are to define the incidence, categories of infections by~     organ systems, etiologic agents and risk factors for infections in different pediatric~     malignancies. The results of this study will help the investigators to better understand the~     epidemiology of infections in the different types of pediatric malignancies, enable the~     investigators to identify high risk patients, and design a better approach to empiric~     treatment of these patients.~      A prospective, multi-center study, conducted in 5 pediatric hematology-oncology units across~     Israel (Rambam Medical Center, Haemek Medical Center, Schneider Children's Medical Center,~     Hadassah Medical Center, Soroka Medical Center). All children aged 0-18 years of age, newly~     diagnosed with cancer and admitted to day care or inpatient departments with fever of >38.0 C~     will be included in the study. Demographic, clinical and microbiological figures will be~     collected in each center by a research assistant supervised by the infectious disease~     specialist. Data will be collected according to a pre-defined Patient Data Form and entered~     into an electronic data base that will be analyzed accordingly. In each event of febrile~     episode during chemotherapy, the following data will be collected by a research assistant~     using a patient data form and computerized software:~        -  Demographic data: age, gender, ethnicity.~        -  Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of~          central venous catheter, intensity of chemotherapy, duration of fever, duration and~          severity of neutropenia, diagnosis of present event.~        -  Imaging data~        -  Microbiological data~        -  Outcome~      The statistical analysis will be performed by an epidemiologist and statistician using the~     SPSS 12.0 software.~   "
200822|NCT00934102|"~     The purpose of this study is to assess the ophthalmic compatibility of three different~     silicone hydrogel lenses worn on an overnight basis for six nights.~   "
200823|NCT00934089|"~     This study will characterize the effect of PF-04217329, alone and in combination with~     latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood~     samples will be collected to measure the amount of active metabolite of PF-04217329 in the~     plasma following dosing.~   "
200824|NCT00934076|"~     The purpose of this study the safety and effectiveness of oral AT-101 when given with the~     standard dose of erlotinib (Tarceva)to patients who are older that 18 and who have advanced~     non-small cell lung cancer, who have relapsed or progressed on prior platinum-based~     chemotherapy.~      It is proposed that the effects of AT-101 may improve the clinical benefit of erlotinib in~     patients with advanced NSCLC.~   "
200825|NCT00934063|"~     This observational study is conducted in Europe. The aim of this observational study is to~     investigate the changes in a score (GET-score) which includes quality of life, body~     composition and cholesterol metabolism in patients on growth hormone treatment. The GET score~     stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative~     measurement of the efficacy of the treatment with growth hormone in adults.~   "
200826|NCT00934050|"~     The purpose of this study is to evaluate the long-term safety and tolerability of ELND005~     beyond the 18 months of treatment in original randomized and blinded clinical trail~     ELND005-AD201.~   "
200827|NCT00934037|"~     The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed~     tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥~     50% and a corresponding myocardium perfusion defect in a patient with suspected coronary~     artery disease compared with conventional coronary angiography and single photon emission~     computed tomography myocardium perfusion imaging.~   "
200830|NCT00933998|"~     The purpose of this research study is to determine if Metanx improves sensory neuropathy in~     persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a~     physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which~     are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be~     assigned to receive Metanx for 12 months. Baseline quantitative sensory testing will be done~     before the patient receives Metanx. Additional quantitative sensory testing will be done at 6~     and 12 months to evaluate.~   "
200831|NCT00933985|"~     This phase I trial is studying the side effects and best dose of obatoclax mesylate when~     given together with vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane~     hydrochloride in treating young patients with relapsed or refractory solid tumors, lymphoma,~     or leukemia. Obatoclax mesylate may stop the growth of cancer cells by blocking some of the~     proteins needed for cell growth and causing the cells to self-destruct. Drugs used in~     chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving obatoclax mesylate together with~     combination chemotherapy may kill more cancer cells.~   "
200832|NCT00933972|"~     This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of RO4998452 in~     type 2 diabetes patients with varying degrees of renal impairment. Eligible patients will be~     divided into 4 groups, with normal renal function, or mild, moderate or severe renal~     impairment. All patients will receive a single oral dose of RO4998452 in the fasted state.The~     anticipated time on study treatment is <3 months (single dose study)and the target sample~     size is <100 individuals.~   "
200833|NCT00933959|"~     The aim of the proposed pilot study is to scientifically evaluate the use of Mind-Body~     Bridging Program (MBBP) as an effective intervention for improving health outcomes in~     veterans exhibiting sleep disturbance in the Primary Care Clinic at the Veterans~     Administration Salt Lake City Health Care System (VASLCHCS).~   "
200834|NCT00933946|"~     Primary Objective:~      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated~     dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.~   "
200835|NCT00933933|"~     To test blood specimens using a new investigational test that detects antigen and antibody to~     human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test~     and supplemental testing performed to determine HIV status.~   "
200836|NCT00933920|"~     The purpose of this study is to determine the effect of a light meal on the pharmacokinetics~     and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.~   "
200837|NCT00933907|"~     Primary Objective:~      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated~     dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFR.~   "
200838|NCT00933894|"~     The purpose of this study is to investigate the effect of steady-state telaprevir (TVR) 750~     mg q8h (3 times a day, every 8 hours) on the steady-state pharmacokinetics of escitalopram 10~     mg q.d. (once a day), and vice versa. Steady state is a term which means that the drug has~     been given long enough so that the plasma concentrations will remain the same with each~     subsequent dose. TVR is being investigated for the treatment of chronic hepatitis C virus~     (HCV) infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream,~     distributed in the body and eliminated from the body.~   "
200839|NCT00933881|"~     This study is designed to evaluate the amount of heart rate variability (HRV) for women with~     gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient~     sleep-disordered breathing (SDB) during pregnancy.~   "
200840|NCT00933868|"~     The purpose of this study is to evaluate the effect of six intravenous (IV) infusions of~     magnesium chloride versus placebo in patients who have residual muscle weakness from a stroke~     that occurred three months to four years ago.~   "
200841|NCT00933855|"~     The purpose of this study is to test a class for Queens Cancer Center patients. We want to~     find out if patients think this program is helpful.~   "
200842|NCT00933842|"~     Primary Objective:~      To demonstrate the absence of photoirritation and photosensitization potential of the product~     Dermacyd PHDESILSTYFL.~      Secondary Objective:~   "
200843|NCT00933829|"~     The primary objective of this prospective, randomized study is to compare cosmetic outcomes~     between absorbable and non-absorbable sutures in truncal and extremity lacerations in the~     pediatric and adult population. Secondary outcome measures include wound complications such~     as infection and wound dehiscence at the initial visit; and parental satisfaction and keloid~     formation after three months post repair.~   "
200844|NCT00933816|"~     The purpose of this study is to determine the recommended dose of the combination therapy of~     sorafenib with hepatic arterial infusion of low dose cisplatin and fluorouracil on patients~     with advanced hepatocellular carcinoma (Phase I), and to evaluate the efficacy of this~     combination therapy in the recommended dose (Phase II).~   "
200845|NCT00933790|"~     Acquired Rifampicin Resistance has emerged as an important issue in the treatment of HIV-TB~     patients. It has not been a major problem in HIV-negative individuals treated for TB treated~     with standard intermittent regimens. The study would generate data on the efficacy of daily~     and thrice weekly regimen of ATT in pulmonary TB patients with HIV in the presence of highly~     active antiretroviral therapy (HAART). Not many trials have compared sputum conversion and~     adverse drug reaction between daily and intermittent regimens of ATT in HIV positive~     patients. This study provides a unique opportunity for comparison of daily and intermittent~     therapy for HIV patients with pulmonary TB looking into multiple dimensions of HIV-TB~     treatment namely efficacy, drug resistance, toxicity , drug interaction and immune~     reconstitution inflammatory syndrome. The primary outcome of the study is to compare the~     efficacy of three anti-TB regimens in a) reducing bacteriological failures and b) decreasing~     the emergence of Acquired Rifampicin Resistance (ARR). The secondary outcomes include~     unfavourable responses (clinical failures, deaths, relapses) as whole, treatment emergent~     adverse drug reactions, pharmacokinetic levels of ATT and incidence of immune reconstitution~     syndrome.~   "
200846|NCT00933777|"~     Dose finding part: A phase I clinical trial to evaluate the safety of combined sorafenib and~     everolimus treatment in patients with relapsed solid tumors (finished).~      Extension part:Treatment of non-small cell lung cancer (NSCLC) with KRAS mutation after ≥ 1st~     relapse (recruiting)~   "
200847|NCT00933764|"~     This is a multi-center study designed to assess the accuracy and precision of the Cholestech~     LDX Cardiac hsCRP test for the quantitative determination of C-reactive protein (CRP) in~     whole blood, serum and plasma from individuals being assessed for risk of cardiovascular~     disease. The Cholestech LDX Cardiac hsCRP test consists of the CRP cassette and LDX analyzer~     and measures CRP with high sensitivity on fingerstick or venous whole blood at the~     point-of-care (POC). The results of this study are intended to be used for regulatory 510k~     filings for use as an in vitro diagnostic test.~   "
200848|NCT00933751|"~     Tissue hypoxia is one of the most important factors leading to the development of multiorgan~     failure. Patients presenting for emergent major abdominal surgery might suffer from organ~     hypoperfusion. Thus, early detection of the imbalance between oxygen supply and demand may~     improve the outcome. The investigators believe that hypoperfusion of the abdominal organs~     will cause a decrease of the saturation in the hepatic vein and in the IVC.~   "
200849|NCT00933738|"~     This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio~     Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally~     modified for low sample volume. The INRatio test strip is used for the quantitative~     determination of PT and International Normalized Ratio (INR) results in fingerstick blood~     from subjects on oral anticoagulation therapy (OAT) with warfarin. This study is designed to~     evaluate the accuracy of the modified INRatio test strip during heparin-warfarin bridge~     therapy with unfractionated heparin (UH) or low molecular weight heparin (LMWH), such as~     enoxaparin or dalteparin. These INR results will be compared to the INR results obtained on~     plasma from the same subjects as analyzed at a central laboratory with the~     heparin-insensitive reference method: the Sysmex CA-560 System. The levels of UH or LMWH in~     the plasma samples will be assessed using activated partial thromboplastin time (aPTT) and~     anti-factor-Xa assays respectively.~   "
200850|NCT00933725|"~     The purpose of this multiple-centered, randomized, controlled study is to investigate the~     efficacy and safety of a combination using herbs prescription and traditional Chinese~     medicine (TCM) emotion treatment in women with menopausal syndrome.~   "
200851|NCT00933712|"~     Primary Objective:~      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated~     dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Floral~   "
200852|NCT00933699|"~     Primary Objective:~      To prove the safety of the gynaecological formulation in normal conditions of use.~   "
200853|NCT00933686|"~     The purpose of this study is to evaluate the efficacy of recombinant human growth hormone~     (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.~   "
200854|NCT00933673|"~     The purpose of this study is to evaluate the efficacy and tolerability of the combination~     chemotherapy of L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell~     lymphoma.~   "
200855|NCT00933660|"~     The hypotheses that will be studied are:~      H0: Providers trained by a web based application for skill competency in basic life support~     (BLS) and automated external defibrillation (AED) are as competent as those who were trained~     by certified instructors using the European Resuscitation Council (ERC) curriculum~      H00-1: Providers who trained themselves with the used of web based training are more~     competent when they had a personal manikin for home exercise compared to providers who~     trained themselves with only a web based training~      H0-2: Providers who did not receive any training will score lower than those who did.~      Research questions for this study are:~        1. What are the results in skill competency for non trained people?~        2. What are the results in skill competency for trained people immediately after training?~        3. What is the retention of skills for trained and non trained people after six months?~   "
200856|NCT00933647|"~     The investigators aim to study the effects of green tea and maté consumption on lipid and~     inflammatory profiles in dyslipidemic and overweight subjects.~   "
200857|NCT00933634|"~     The optimal strategy to restore sinus rhythm in patients with atrial fibrillation (AF) of~     less than 48 hours' duration is still controversial. The investigators performed a controlled~     single-center trial to compare electrical and pharmacological (propafenone) cardioversion to~     restore the sinus rhythm in selected patients with acute atrial fibrillation.~   "
200858|NCT00933621|"~     The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow~     (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for~     revascularization.~   "
200859|NCT00933608|"~     Recent data show that marked cell damage precedes the clinical manifestation of Alzheimer's~     disease (AD). Hence, targeting populations at risk with pharmacological interventions is a~     possible strategy to lessen the burden of the disease. Cognitively normal individuals with~     subjective memory complaints (SMC) manifest biological characteristics consistent with early~     AD and are at risk for future cognitive decline. Family history of AD also constitutes a~     risk. In a previous study the investigators showed that memantine slows down the accumulation~     of phosphorylated tau in normal SMC subjects. Using a multivoxel high field MR spectroscopy~     (MRS) technique, the investigators also demonstrated that memantine decreased hippocampal~     glutamate. Both these findings may be consistent with the drug's anti-excitotoxic activity.~     In this new project the investigators propose to treat a sample of 12 presymptomatic~     individuals at risk (SMC and family history of AD) with memantine. This will be a double~     blind, placebo controlled study with a control group (12 non-treated subjects). The~     investigators will determine whether the effects of memantine as assessed by cognitive~     performance and MRS are present after 4 months of treatment and persist 2 months after~     discontinuation. MRS will be used to evaluate the effect of memantine on levels of the~     neurotransmitter glutamate and neuronal viability marker N-acetylaspartate (NAA) in the~     hippocampus. The investigators will test the following hypotheses:~        1. In subjects with SMC, memantine has modifying effects on brain biochemistry as reflected~          in MRS reductions in glutamate (reduced excitotoxicity) and increases in NAA (neuronal~          integrity).~        2. The effects of the drug persist (as a marker of sustained neuroprotection) and can be~          measured 2 months after discontinuation of the treatment.~   "
200860|NCT00933595|"~     The Lung HIV goal is to facilitate the data and specimen collection efforts of eight~     individual HIV and pulmonary studies that operate under the direction of the NHLBI. The Lung~     HIV study will build on existing studies to facilitate the start-up of new projects to~     further the understanding of the relationship between pulmonary disease and HIV infection.~     There is only one clinical trial being performed in this network at Ohio State University and~     it will be reported here.~   "
200884|NCT00933283|"~     The purpose of this study is to evaluate the effect of steady-state (constant concentration~     of medication in the blood) telaprevir 750 mg every 8 hours on the steady-state~     pharmacokinetics (how the drug concentrations change over time) of R- and S-methadone.~   "
202221|NCT00915499|"~     The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or~     continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over~     time.~   "
200861|NCT00933582|"~     The purpose of this single-center study is to evaluate the potential analgesic effects of a~     single oral dose (50 mg) of JNJ-39439335, an investigational drug being developed for the~     treatment of pain in patients with chronic osteoarthritis pain of the knee. The study will~     also evaluate the pain treatment response assessments and methods being used in this study.~     Participants will also take naproxen (500 mg) and placebo (an inactive substance) during the~     study. Pain assessments after taking JNJ-39439335, naproxen and placebo will be compared.~   "
200862|NCT00933569|"~     Primary Objective:~      To prove the safety of the gynaecological formulation in normal conditions of use.~   "
200863|NCT00933556|"~     The purpose of this study is to investigate the feasibility, safety and efficacy of oral~     probiotic, VSL#3 versus oral placebo for reducing colonization by VRE.~   "
200864|NCT00933543|"~     The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from~     9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream~     without occlusion and red light(dose: 37J/cm2)~   "
200865|NCT00933530|"~     The purpose of this study is to determine the safety and tolerability of SRT2104 (0.03, 0.1,~     0.25, 0.5, 1.0, 2.0, and 3.0 g/day) in healthy male volunteers when administered after a~     single dose and once daily for 7 consecutive days.~      The purpose is also to characterize the pharmacokinetic profile of SRT2104 (0.03, 0.1, 0.25,~     0.5, 1.0, 2.0, and 3.0 g/day) after a single dose and multiple administrations in healthy~     male volunteers.~   "
200866|NCT00933517|"~     The purpose of this study is to assess the pathological response rate in operable breast~     cancer patients treated by neoadjuvant combination: FEC-Taxotere/Vectibix.~   "
200867|NCT00933504|"~     Primary Objective:~      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated~     dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFL.~   "
200868|NCT00933491|"~     Dental implants are regarded as a standard of care in restoring missing teeth. Although there~     is a high prevalence of diabetics who receive dental implants, the relationship between~     dental implants and diabetes has not clearly been investigated.~      A total of 32 subjects (14 patients with type II diabetes and 18 non-diabetes subjects) who~     have dental implants were recruited. The purposes of this research study were: (1) to~     evaluate diabetes patients to determine risk factors for bone loss at dental implants and~     teeth; and (2) to evaluate bone-resorptive biomarkers (proteins related to bone loss) present~     in saliva and blood serum, comparing the two groups.~   "
200869|NCT00933478|"~     The Eustachian tube is a tube that connects the back of the nose with the ear. Its job is to~     keep the pressure on the inside of the eardrum close to the pressure outside the eardrum, so~     that the eardrum can vibrate properly. Usually this tube is closed, but it opens briefly~     during swallowing. In the condition called patulous eustachian tube, this tube is open all~     the time. This is a benign condition but it can be very bothersome to patients.~      The incidence of patulous Eustachian tube dysfunction is about 0.3-6.6% of the population.~     However, about 15% of the people who have this condition are bothered enough by it that they~     seek medical attention. This condition is more common in females than males and is more~     common in adults than children.~      Some of the common symptoms of patulous eustachian tube can include roaring tinnitus~     synchronous with nasal respiration, audible respiratory sounds, sensation of a plugged ear~     and fluctuating aural fullness.~      In most cases the cause is idiopathic. Some predisposing factors include weight loss,~     stress,anxiety,fatigue, pregnancy, and temporomandibular joint syndrome. It can also be~     caused by adhesions in the nasopharynx following surgery on the adenoids. Sometimes it can be~     associated with medications such as diuretics and oral contraceptives. Neuromuscular~     disorders that cause atrophy such as multiple sclerosis, stroke and motor neuron disease have~     also been postulated to cause patulous eustachian tube.~      The purpose of this trial is to learn more about the condition and help us learn about how~     the eardrum might be treated to prevent it vibrating with sounds or noises coming up the~     Eustachian tube.~      The first part of the study will consist of a questionnaire to help to further define the~     symptoms of patulous eustachian tube, and to measure how severe these symptoms are.~      Currently there are few treatments that are satisfactory for patients. Common surgical~     therapies include injections of various substances into the Eustachian tube opening including~     paraffin, Teflon,or gelfoam. Unfortunately, these methods are either temporary or have lead~     to serious complications including cerebral thrombosis and death (due to inadvertent~     injection into the carotid artery). Other treatments have focused on cauterizing the~     Eustachian tube opening but these have been either unsatisfactory or caused damage to the~     trigeminal nerve. Myringotomy and insertion of a ventilation tube has helped some patients~     but others have found that this increased the patient's discomfort.~      The investigators have been treating patients recently by placing some putty like clay~     material on the eardrum, which stops it vibrating so much with the patient's own voice, and~     this appears to be quite effective for many patients. It is also easily removed if the~     patient does not find it helpful. However, the investigators do not really have a good idea~     of exactly which patients are helped by this, and which are not, and just how much their~     symptoms are helped, as well as how long the treatment helps them for.~   "
200870|NCT00933465|"~     Faecal incontinence (FI) is a debilitating and often neglected problem. It can be defined as~     the loss of voluntary control of liquid or solid stool.It is estimated that 2-3% of western~     adults suffer from FI with prevalence increasing with age, further to this up to 50% of~     nursing home residents suffer too with it more common in females. Aetiology is often~     multi-factoral, where obstetric anal sphincter injury is most common is females and~     iatrogenic anal sphincter injury is most common in males.~      Loperamide (imodium) is a constipating agent used as first choice pharmacological agent due~     to its high efficacy. Trials have suggested it thickens stool consistency and may raise~     resting anal sphincter pressure, associated with improved clinical function with a reduction~     in bowel frequency and urgency, a reduction in incontinence and less need for pads.~      Loperamide is well tolerated but has been known to cause side effects of abdominal pain and~     distension, nausea and vomiting and constipation.~      Imodium can be taken in two ways; as syrup (1mg/5mls) or tablets (2mg). There have been no~     comparative studies. Side effects are mainly seen with the tablet form and so it is~     hypothesized that the syrup form is better tolerated because it is more accurately titrated~     to effect.~      This is a NHS funded single blinded, randomised, cross-over study to assess the clinical~     effects of Imodium, in tablet and syrup form, on patients presenting with faecal~     incontinence. Each subject will act as their own control. Patients will be recruited through~     out-patient visits for their FI, where they will be made aware of the trial. During the trial~     they will be asked to fill out FI scoring questionnaires and quality of life scores. Also~     they will undertake two assessments of anal physiology testing squeeze pressures, sensation~     and compliance at baseline and at the end after three months.~   "
200871|NCT00933452|"~     The primary objective of this study is to evaluate the pharmacokinetics of duloxetine~     hydrochloride tablets in Chinese Han Healthy Subjects. The single oral dose and multiple oral~     dose of the drug in the body and the effects of different dosages of the drug will also be~     evaluated.~   "
200872|NCT00933439|"~     The purpose of this study is to study the effect of duloxetine treatment on (1) cognitive~     functions, the brain mechanisms involved with thinking, reasoning, learning, and remembering;~     (2) psychosocial functions, how someone interacts with his/her social environment; and (3)~     the relationship between these two functions, in people who have major depressive disorder, a~     severe form of depression.~   "
200873|NCT00933426|"~     The goal of the Phase I part of this clinical research study is to find the highest tolerable~     dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients~     with prostate cancer who have failed treatment with taxanes.~      The goal of the Phase II part of this clinical research study is to learn if lenalidomide and~     paclitaxel can help to control prostate cancer.~      The safety of this combination treatment will be studied in both phases of the study.~      UPDATE:~      Study was terminated early due to slow accrual as a Phase I dose escalation study, without~     progression to Phase II study portion.~   "
200874|NCT00933413|"~     Primary Objective:~      To prove the safety of the gynecological formulation in normal conditions of use.~   "
200875|NCT00933400|"~     This multi-center, randomized, controlled trial conducted in Emergency Departments (ED)~     compares computed tomography (CT) coronary angiography with the traditional approach (usual~     care) for low- to intermediate-risk chest pain patients. The primary objective is to estimate~     the rate of major cardiac events (heart attack or cardiac death) within 30 days in trial~     participants in Group B who were not found to have significant coronary artery disease by CT~     coronary angiography. Additional evaluations will comprise health care utilization~     assessments, including length of hospital stay and re-admissions, cost analysis, and 1-year~     post-triage/presentation major cardiac event rates.~   "
200885|NCT00933270|"~     This is a prospective, multicenter, non-randomized, single arm, pivotal trial.~      The main objective of this study is to demonstrate the safety and effectiveness of the IDev~     SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery~     (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12~     months. The outcome will be compared to a performance goal based on clinical trials of~     percutaneous transvenous angioplasty (PTA) alone.~   "
200886|NCT00933257|"~     Primary Objective:~      To demonstrate the absence of photoirritation and potential photosensitization of the product~     Dermacyd PHDESILSTYFR.~   "
200876|NCT00933387|"~     Surgical resection followed by concurrent chemoradiotherapy is considered as the standard of~     care for locally advanced OSCC (LAOSCC). Although the treatment could provide prompt local~     control, but it is also associated with high incidence of distant failure. Systemic~     chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment~     has been extensively evaluated to improve the clinical outcome in LAOSCC. Regimens of~     taxane/cisplatin-based combinations have been shown to improve the treatment outcome of~     patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in neoadjuvant~     setting. Recently, cetuximab (Erbitux®), a monoclonal antibody against epidermal growth~     factor receptor (EGFR), has also been proven to be an efficient agent for advanced and/or~     refractory HNSCC with acceptable toxicity profiles. In current study, we shall evaluate the~     feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab,~     paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (CBRT) in~     patients with LAOSCC.~   "
200877|NCT00933374|"~     This is a single arm open- label phase II- trial evaluating safety and efficacy of paclitaxel~     and RAD001 in patients with metastatic urothelial bladder cancer who failed prior~     platin-based systemic therapy.~   "
200878|NCT00933361|"~     Cachexia, a condition of severe malnutrition, negative nitrogen balance, muscle wasting,~     weight loss, and anorexia, is a frequent affecting more than 80% of patients in advanced~     cancer disease causing a high burden on patients and their families. Nutritional,~     pharmacological, and behavioural interventions for cancer-related ACS and associated symptoms~     have, despite the importance for cancer care, limited effect on only a minority of patients.~     New strategies are required.~      Ghrelin, a 28 amino acid peptide discovered in 1999, is predominantly secreted by gastric~     endocrine cells and is an endogenous ligand for the growth hormone secretagogue (GHS)~     receptor. When administered peripherally it stimulates growth hormone secretion, food intake,~     triggers a positive energy balance, produces weight gain through a central mechanism~     involving hypothalamic neuropeptides and has anti-inflammatory effects. A recently completed~     trial on intravenous ghrelin in advanced cancer patients with ACS reports good tolerability~     and safety of single intravenous application of 2 and 8μg/kg Ghrelin.~      Given the facts that ACS is a major burden in patients suffering advanced cancer disease and~     ghrelin is a major signal for stimulating food intake, promoting positive energy balance and~     weight gain and may have anti-inflammatory effect it remains to be determined whether the~     administration of ghrelin will have a positive clinical effect on cancer anorexia/ cachexia~     syndrome ACS. The next logical clinical development step is a proper dose-finding study of~     twice daily subcutaneous administration and proof-of-concept of main outcomes.~   "
200879|NCT00933348|"~     The purpose of this study is to examine the safety and efficacy of the fruit-based product~     OPAL A for the treatment of chronic venous and pressure ulcers.~   "
200880|NCT00933335|"~     This is a single-arm, single institution, phase II study of fludarabine monophosphate~     followed by Iodine I 131 Tositumomab for patients with previously untreated, advanced-stage~     (stage III or IV) low-grade, transformed low-grade and follicular non-Hodgkin's lymphoma. The~     primary objective of the study will be to evaluate the safety of this treatment combination~     and the secondary endpoint will be to evaluate efficacy.~   "
200881|NCT00933322|"~     The aim of the study is to compare a diet rich in trans fatty acids (TFA) from ruminant~     sources with a diet rich in TFA from hydrogenated vegetable oils (PHVO) in regard to their~     effects on cardiovascular risk markers (endothelial function, blood lipids, inflammation and~     coagulation parameters in the blood).~      After a two week run-in period (diet without TFA) volunteers are randomized into three groups~     with different diets: diet rich in TFA from ruminant sources, diet rich in TFA from PHVO and~     diet without TFA. The intervention period lasts four weeks.~      A nutritionist introduces the basic issues of the study diets. All volunteers supply~     themselves according to the recommendations of the Swiss food pyramid. Fat free food can be~     chosen individually in the context of defined guidelines. The amount and source of the fat in~     the diet are strictly defined. During the whole study, volunteers meet the nutritionist every~     2 weeks, and in the weeks between, the volunteers are contacted by phone.~      The volunteers will continue their normal daily life and physical activities. At the~     beginning of the run-in period and at the beginning and the end of the intervention period~     the endothelial function of the brachial artery will be assessed using flow-mediated dilation~     (FMD)/nitro-mediated dilation (NMD) methods and blood samples will be collected to analyze~     blood lipids, inflammation and coagulation parameters in the blood.~      Hypothesis:~        1. Diet enriched with ruminant TFA has not the same negative effect on cardiovascular risk~          markers as diet enriched with the same amount of industrial TFA compared with a diet~          without TFA.~        2. Diet enriched with ruminant TFA has not a more negative effect on cardiovascular risk~          markers as diet without TFA.~   "
200882|NCT00933309|"~     The goal of this clinical research study is to find the highest tolerable dose of Avandamet~     that can be given in combination with exemestane to patients who are obese and postmenopausal~     with hormone-receptive-positive breast cancer that has spread to other parts of the body.~   "
200883|NCT00933296|"~     The Schnitzler syndrome is a rare entity characterized by an urticarial rash and recurrent~     fever in a patient with a monoclonal IgM component. Other frequent signs include joint, bone~     and muscle pain, enlarged spleen, liver and lymph nodes, increased blood sedimentation rate~     (BSR), elevated neutrophil count and abnormalities on bone morphologic investigations. In~     2001, the investigators proposed criteria to diagnose this syndrome, which are currently~     admitted in the literature. The main complications of the Schnitzler syndrome are a~     difficult-to-control inflammatory anemia, AA-amyloidosis and malignant B lymphoproliferative~     disorders. About 15% of patients with a Schnitzler will eventually develop a~     lymphoproliferative disorder; thus this syndrome allows studying the relationship between~     lymphomagenesis and inflammation. By many aspects, the Schnitzler syndrome is reminiscent of~     auto-inflammatory syndromes. Though the term auto-inflammatory disease is as to yet~     restricted to diseases with Mendelian inheritance, some polygenic inflammatory diseases like~     for example Crohn's disease clearly involve pathogenetic pathways shared with the monogenic~     auto-inflammatory syndromes. The investigators stipulate that this could also be the case in~     the Schnitzler syndrome for the following reasons: (1) this is a recurrent fever of unknown~     cause; (2) the peculiar eruption, characterized pathologically by a neutrophilic infiltrate~     very similar to the one observed in the auto-inflammatory cryopyrinopathies (CINCA/NOMID~     syndrome, Muckle-Wells syndrome and familial cold-urticaria); the investigators recently~     individualized this particular eruption, significantly associated with systemic inflammatory~     disease, within the group of neutrophilic urticarias (Kieffer et al. Medicine, in press); (3)~     the occurrence of aseptic neutrophilic osteitis, very similar to the one reported in patients~     with Majeed syndrome, another auto-inflammatory syndrome; (4) a significant increase of~     neutrophil count, not otherwise explained; (5) a spectacular response to the IL-1 inhibitor,~     within hours after the first injection, similar to what is reported in the PAPA (pyogenic~     arthritis, pyoderma gangrenosum and acne) syndrome or the cryopyrinopathies, suggesting a~     direct pathogenic effect of IL-1.~   "
200887|NCT00933244|"~     The purpose of this study is to answer the following questions: Does vitamin D increase~     calcium absorption, bone mass and muscle mass and function in women past menopause who have~     mildly low vitamin D levels? Do these benefits require prescription-strength vitamin D, or is~     an over the counter vitamin D dose enough?~   "
200888|NCT00933231|"~     This is a multicentre study examining the use of Advagraf-minimization strategy and/or the~     use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal~     allografts.~   "
200889|NCT00933218|"~     The purpose of the study is to determine the myocardial function and vascular adaptation~     after strenuous exercise in association with consumption of polyphenols. The investigators~     aim to investigate the effects of extreme endurance exercise on the inflammatory system.~     Furthermore, the role of the cardiovascular response and adaptive mechanisms of the~     vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being~     investigated.~   "
200890|NCT00933205|"~     The purpose of this Open Label Safety Study is to provide access to and evaluate the safety~     and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who~     have failed at least two PI-containing regimens, and have limited treatment options.~   "
200891|NCT00933192|"~     The evaluation of skeletal muscle strength in severly ill or cognitive impaired patients is~     an unresolved problem especially during the rehabilitation process. The aim of this study is~     to correlate morphological parameters assessed with muscle ultrasound and isometric muscle~     strength to establish an objective progression parameter for rehabilitation therapies.~   "
200892|NCT00933179|"~     The aim of the present study is to investigate the effects of the transdermal patch on the~     parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism~     in healthy women who require contraception.~   "
200893|NCT00933166|"~     The purpose of this trial is to assess the performance of an investigational contact lens~     over a three month period.~   "
200894|NCT00933153|"~     Researchers will measure weight, height, hand grip strength and quality of life information~     of Meals on Wheels (MOW) clients who are considered to have nutrition problems. Participants~     will randomly be put into a group that receives either typical meals from Meals on Wheels or~     Ensure Plus supplements with their meals. Three months later the same data will be collected~     again. The objective of this study is to demonstrate the effectiveness of providing oral~     nutritional supplements (ONS) to MOW clients with or at risk of malnutrition on nutritional~     status over a 3-month period.~   "
200895|NCT00933140|"~     The population of HIV infected women seen at Boston Medical Center may have a higher~     frequency of anal cytologic and histologic abnormalities than what is reported for the~     non-HIV infected population.~   "
200896|NCT00933127|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at blood and tissue samples from patients with~     follicular lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride,~     vincristine, and prednisone.~   "
200897|NCT00933114|"~     Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted~     (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography~     (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and~     normal tissues based on physiologic properties including perfusion, vascular permeability and~     glucose metabolism. Demonstrating that these parameters are associated with clinical outcome,~     either efficacy or toxicity, could enhance the ability to select patients for different~     treatment strategies and improve the therapeutic ratio.~   "
200898|NCT00933101|"~     The purpose of this study is to find out if diabetes damages the blood vessels of adolescents~     with good diabetes control compared to adolescents with less optimal control.~   "
200899|NCT00933088|"~     The aims of this study are to determine the differential coping strategies used by adolescent~     daughters whose mothers have breast cancer, and how this relates to the stress responses they~     exhibit.~   "
200900|NCT00933075|"~     Primary Objective:~      To demonstrate the absence of photoirritation and photosensitization potential of the product~     Dermacyd Silver Frutal.~   "
200901|NCT00933062|"~     The purpose of this study is to assess the pharmacokinetic profile, safety, and tolerability~     of SRT2104 following administration of single and multiple oral doses (once a day for seven~     days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.~   "
200902|NCT00933049|"~     The investigators hypothesized that Oral amoxicillin (25mg/kg/dose bid) given to children~     aged 2-59 months with pneumonia, would lead to better clinical outcome on day three in 89.9%~     of the children compared to 77.0% of children receiving oral cotrimoxazole (8 mg/kg/dose~     trimethoprim, 40 mg/kg/dose sulphamethoxazole). A double blind randomized controlled trial~     was conducted in the Assessment Center of Mulago Hospital. Children with non-severe pneumonia~     were randomized to receive either oral amoxicillin (25 mg/kg/dose) or cotrimoxazole~     (trimethoprim 8 mg/kg and sulphamethoxazole 40 mg/kg) and followed up on day 3 and 5 of~     treatment. The primary outcome measures were normalization of respiratory rate by day 3 of~     treatment. Secondary outcome measures were antimicrobial susceptibility to cotrimoxazole and~     amoxicillin.~   "
200903|NCT00933036|"~     The clinical trial is being conducted to evaluate the performance of the Crosstrees System in~     reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and~     kyphoplasty.~   "
200904|NCT00933023|"~     Topical steroids are used as treatment for non-retractile foreskin in children for decades,~     but, there are disagreement among physicians about the optimum potency of the agent used.~     This study is designed to determine any difference in the beneficial effects of mild versus~     potent topical corticosteroids in treatment of non-retractile foreskin in children.~   "
200905|NCT00933010|"~     The aim of the study is to assess the prevalence of Metabolic Syndrome in Italy on a regional~     basis, defined according to NCEP/ATPIII Guidelines criteria.~   "
200951|NCT00932373|"~     This is a phase I, multicenter, open-label, dose-escalation study of single-agent~     trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive~     metastatic breast cancer (MBC) who have previously received trastuzumab. The study will~     assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine~     the dose and schedule to be used in Phase II.~   "
200906|NCT00932997|"~     RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the~     psychological and physical impact of breast cancer and increase awareness of available~     resources. It is not yet known whether survivorship booklets are more effective when given~     alone or together with individual telephone sessions in informing breast cancer survivors.~      PURPOSE: This randomized clinical trial is studying individual telephone sessions given~     together with survivorship booklets compared with survivorship booklets alone to see how well~     they work in increasing knowledge about the impact of breast cancer in African American and~     Latina breast cancer survivors.~   "
200907|NCT00932984|"~     Primary Objective:~      To demonstrate the absence of photoirritation and potential photosensitization of the product~     Dermacyd Silver Floral.~   "
200908|NCT00932971|"~     Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus~     placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta~     hepatitis. 70 Patients will be randomized 1:1 into the two groups. Treatment duration: 96~     weeks. Follow-up: 24 weeks. Long-term-follow-up: until week 358.~   "
200909|NCT00932958|"~     This protocol describes an observational study whose goal is to collect de-identified~     Coronary CT Angiography (CCTA) acquisition factors and interpretations (findings) from~     several hundred U.S. and international imaging facilities. The study uses an electronic data~     capture tool to collect de-identified CCTA utilization parameters and clinical findings in~     order to create a multi-center registry. This registry will be used for scientific analysis~     and publication of pertinent medical trends such as CT utilization, radiation dose, and~     common cardiovascular findings. The registry will be used to determine areas of interest for~     future randomized controlled trials.~      All data will be collected with patient identifiers removed and in complete accordance with~     HIPAA regulations. All data will be analyzed in aggregate, thus further minimizing the risk~     of patient confidentiality violations.~   "
200910|NCT00932945|"~     Primary Objective:~      To prove the safety of the gynecological formulation in normal conditions of use.~   "
200911|NCT00932932|"~     The purpose of the study is to find out if people with Prader-Willi syndrome have a~     difference in the protein which changes inactive cortisone to the active stress hormone~     cortisol.~   "
200912|NCT00932919|"~     The purpose for this study is to find out if Thought field therapy has the same effect as, or~     better effect than, Cognitive therapy for Agoraphobia.~   "
200913|NCT00932906|"~     This study is a prospective, randomized trial that compares the effectiveness and retention~     of four different training methods for the use of an AED:~      A. Traditional instructor based learning;~      B. The use of a personal manikin with a DVD training to practice the necessary AED skills;~      C. The use of a personal manikin with a DVD training to practice the necessary AED skills and~     additional scenario training;~      D. Watching a 2.5 minutes DVD which shows the use of an AED.~      It is hypnotised that there are no differences between these training methods, in which case~     method D is most efficient to reach large number of people to learn BLS/AED skills.~      There are two interesting target groups to reach:~        1. Younger people, as they might give the highest interest after training, as they normally~          live longer.~        2. Older people as they are member of the most important group in risk and have therefore a~          higher change of being a witness of cardiac arrest.~      As there might be differences in the results between different training methods than can be~     related to age, each training group is distinguished to three different groups:~        1. 21 years of younger;~        2. between 21 and 50 years;~        3. older than 50 years.~      It is hypnotised that there are no differences between younger and older students within each~     of the four training methods.~   "
200914|NCT00932893|"~     This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus~     pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific~     gene profile involving the ALK gene after failure of one previous chemotherapy regimen that~     included one platinum drug.~   "
200915|NCT00932880|"~     -  Objective:~             -  The objective of this study was to compare the rate and extent of absorption of the~               test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.),~               with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.),~               when administered under fed conditions.~        -  Study Design:~             -  This was an open-label, randomized, two-way crossover study in which 18 healthy~               subjects were scheduled to receive a single dose of each of two treatments in two~               assigned dosing periods. Each dose administration was separated by a minimum 14-day~               washout period.~   "
200916|NCT00932867|"~     Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension,~     who do not tolerate ACE inhibitoR treatment~   "
200917|NCT00932854|"~     Enlarged glands in the chest (mediastinal lymphadenopathy) is a common problem and may have a~     variety of different causes. In the past an operation (mediastinoscopy) was required to~     diagnose the glands. Endobronchial ultrasound (EBUS) is a new procedure that may be able to~     diagnose these glands without the need for mediastinoscopy. The REMEDY trial aims to examine~     whether EBUS can reduce the number of mediastinoscopies and healthcare costs in patients with~     enlarged glands in the chest.~   "
200918|NCT00932841|"~     The goal of this study is to determine whether the oral administration of the probiotic VSL#3~     under randomized, placebo-controlled conditions will improve symptoms of irritable bowel~     syndrome in children, safely.~   "
200919|NCT00932828|"~     Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is~     to produce a new treatment that would benefit young subjects who have recently been diagnosed~     with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and~     changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).~   "
200920|NCT00932802|"~     The observation period for each patient covered an initial treatment period with Avelox® plus~     optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician~     documented data at any initial visit (baseline) and at least one short-term follow-up visit~     (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were~     documented, and a patient questionnaire was filled in.~   "
200967|NCT00932165|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
200921|NCT00932776|"~     Patients undergoing intubation and mechanical ventilation require removal of secretion by~     means of trachoebronchial suctioning. Timing of the procedure is mainly based on clinical~     parameters. TBA Care® is a new commercially available device designed to generate a signal~     when secretions are present in the respiratory tract of intubated patients, thus indicating~     the need for endotracheal suctioning only when necessary and prior to clinical deterioration.~     In a prospective randomized trial in intubated and mechanically ventilated patients of a~     general ICU the researchers investigated the efficacy of TBA Care® in detecting the presence~     of retained secretions compared to the standard indicators.~   "
200922|NCT00932763|"~     -  Objective:~             -  The objective of this study was to assess the relative bioavailability of two~               formulations of immediate release amlodipine 10 mg under fasted conditions, in~               healthy subjects.~        -  Study Design:~             -  This was an open-label, single-dose, 2-treatment, 2-period, randomized, crossover~               study.Twenty-two healthy subjects were enrolled. Subjects who successfully~               completed the screening process checked into the research center the night before~               first dose. Subjects who continued to meet inclusion/exclusion criteria the morning~               of dose were assigned a subject number, based on the order in which they~               successfully completed the screening process and procedures as outlined in the~               study protocol. Subjects were randomly assigned to a treatment sequence and~               received two separate single-dose administrations of study medication, one~               treatment per period,according to the randomization schedule. Dosing days were~               separated by a washout period of at least 14 days. Subjects received each of the~               treatments listed below during the two treatment periods following an overnight~               fast of at least 10 hours: amlodipine by Torrent Pharmaceuticals Ltd. and Norvasc~               by Pfizer, Inc.~   "
200923|NCT00932750|"~     The goal of this study is to establish the role of coffee mannooligosaccharides (MOS),~     provided in a beverage format, on body weight regulation. Overweight and obese men and women~     will be randomized to one of 2 groups: placebo or MOS beverage. They will be required to~     consume 2 beverages/day for the duration of the 2 phases of the study. The MOS beverage will~     provide 2 g of MOS (total of 4 g/d). This dose level has been found to be well tolerated and~     safe. In the first phase, subjects will be counseled once monthly on a nutrition-related~     topic on an individual basis. They will be asked to maintain their regular eating and~     exercise habits for the duration of the 12 week period. An 8-week washout period will follow~     during which time they will not be required to consume the beverages. The second phase of the~     study will be a weight loss phase. For this phase, subjects will be re-randomized and may~     consume the alternate or the same beverage as the first phase, depending on the outcome of~     randomization. During this phase, they will undergo group counseling on a weekly basis.~     Counseling sessions will focus on weight loss and ways to achieve moderate weight loss of~     approximately 1-2 lbs/week. Measurements will be taken at the beginning and end of each~     phase. This study will allow us to determine whether MOS helps maintain body weight and~     prevent weight gain (first phase) and whether it helps to stimulate weight loss (second~     phase). The results will allow us to find ways in which overweight and obese individuals can~     incorporate beverages in their diets that will help promote weight loss.~   "
200924|NCT00932737|"~     The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB)~     20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment~     of intensity of abdominal pain associated with cramping (APC) in the treatment of two~     episodes.~   "
200925|NCT00932724|"~     This trial is designed as a phase II evaluation of the effect of CY-503 or placebo on~     progression free survival (PFS) defined as the time from start of treatment until the~     objective observation of progressive disease (PD) or death from any course in patients with~     chemotherapy-refractory metastatic colorectal cancer.~   "
200926|NCT00932711|"~     The purpose of this study is to determine if educational intervention is effective in~     reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk~     disease.~   "
200927|NCT00932698|"~     This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD)~     and disease response of IXAZOMIB administered orally in patients with relapsed and/or~     refractory multiple myeloma.~   "
200928|NCT00932685|"~     Preoperative anxiety is characterized by subjective feelings of tension, apprehension,~     nervousness and worry. In children, preoperative anxiety is reported to result in~     postoperative negative psychological effects, including nightmares, eating problems and~     increased fear of doctors. Previous studies have assessed anxiety in children during the~     preoperative period and the effects of premedication and parental presence. Midazolzam has~     been shown to reduce preoperative anxiety in children but post operative recovery maybe~     delayed for children undergoing a short operative procedure. Distraction may be particularly~     helpful in children ages 6-12 as these children are curious about their environment. An~     association between preoperative anxiety and emergence agitation has been suggested.~     Emergence agitation in children is not well understood but is a frightening experience for~     child and parent. A previous study demonstrated the efficacy of hand held video games used as~     an interactive distraction to allay preoperative anxiety. The purpose of this study is to~     treat preop anxiety with premedication, or video game and to evaluate the impact of these~     interventions on the incidence and severity of emergence agitation.~   "
200929|NCT00932672|"~     This study will test the hypothesis that a low-carbohydrate Atkins diet will prevent or at~     least minimize the metabolic consequences of androgen deprivation therapy (ADT).~   "
200968|NCT00932152|"~     This research study will test whether dual anti-estrogen therapy (anastrozole and~     fulvestrant) slows the time to when the cancer progresses.~   "
200969|NCT00932139|"~     Based on previous published research in animals, the investigators hypothesize that~     electroacupuncture (EA) will have a positive effect on hypertension.~   "
200970|NCT00932126|"~     This is the first study using PF-03758309, an oral compound, in patients with advanced solid~     tumors. In this study different doses of PF-03758309 will be administered to different groups~     of patients. The study will assess the compound's safety, the blood levels of PF-03758309~     during the treatment and the effect of the compound on the tumor cells.~   "
200971|NCT00932113|"~     The objective of this study is to compare the mechanism of action between adalimumab and~     methotrexate in subjects with psoriasis.~   "
200930|NCT00932659|"~     Hemodialysis patients have a rate of fatal arrhythmias that is 40 times greater than the~     general population, but the causes and types of fatal arrhythmias they experience is unclear.~     The purpose of this prospective observational cohort study is to capture and characterize~     occult arrhythmias which occur in hemodialysis patients over a 6 month period. After informed~     consent and baseline assessment, 30 adult hemodialysis patients without a prior history of~     cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device~     (REVEAL, Medtronic). Three followup visits will be scheduled to download device data and~     quantify the number of potentially malignant arrhythmias which occur in study subjects during~     the 6 month period. Additionally, captured events will be monitored remotely via regular~     patient initiated transmission of device data every 2 weeks. Any serious occult arrhythmias~     detected will be immediately acted upon with a predefined management algorithm. Descriptive~     data and simple proportions will be used to describe the incidence and types of arrhythmias~     among the study cohort. Risks of this study include 1) potential loss of patient~     confidentiality 2) risks related to insertion of device including pocket hematoma, device~     infection, pain and discomfort secondary to procedure. These will be minimized by strict~     security measures to protect each patient's protected health information (PHI), preprocedural~     screening and insertion of monitoring devices by highly trained operators, and frequent~     careful direct patient followup.~   "
200931|NCT00932646|"~     The study is intended to characterize the lung function profile of BI1744 in COPD patients~     where patients will perform pulmonary function tests at regular intervals for 24 hours at the~     end of a 6 week treatment period. Each patient will receive all four treatments.~   "
200932|NCT00932633|"~     Infants with congenital heart disease (CHD) requiring surgery frequently have brain injury~     seen on magnetic resonance imaging (MRI). This occurs in approximately 40% of these newborns,~     and even though these are full-term infants, the injury seen closely resembles the same form~     of brain injury that can be seen in premature babies. Much like premature newborns, infants~     with CHD also have long-term neurodevelopmental problems (in over 50%).~      The investigators do not know why infants with CHD get this specific form of brain injury.~     One risk factor is felt to be the inflammation that occurs in response to heart-lung bypass~     (cardiopulmonary bypass, or CPB), a necessary feature of open-heart surgery. Newborns have a~     stronger inflammatory reaction to CPB than older children or adults. The investigators do~     know from animal experiments and other human data that inflammation can be harmful to the~     developing brain.~      The investigators hypothesize that children with CHD requiring surgery as a newborn have~     brain injury due to toxicity from the inflammatory response. The investigators will test this~     by enrolling newborns undergoing heart surgery to measure markers of inflammation, measure~     brain injury by MRI, and then test their developmental outcome at 1 and 2 years of age.~      An association between inflammation and injury might impact what medicines are chosen to~     protect the brain in future studies, even in other populations such as preterm infants.~   "
200933|NCT00932620|"~     Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein~     cholesterol (LDL-C) reductions of approximately the same magnitude. However, the differential~     effects of these two treatment options on small dense LDL-C (sdLDL-C) concentration have not~     been assessed.~      The aim of the present study is to compare the effects of simvastatin 40 mg versus~     simvastatin/ezetimibe 10/10 mg on sdLDL-C concentration. The primary efficacy endpoint will~     be changes in LDL subfraction profile (i.e. mean LDL particle size, sdLDL-C levels) at 3~     months after treatment initiation.~   "
200934|NCT00932607|"~     Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC~     Birch is also effective compared to treatment with Staloral Birch by means of reduction in~     allergic symptoms during nasal provocation in subjects suffering from IgE mediated allergic~     complaints triggered by birch pollen.~   "
200935|NCT00932594|"~     The purpose of this study is to look at temporomandibular joint (TMJ) pressure as a guideline~     to analyze the different treatments for temporomandibular disorder (TMD), and judge the~     feasibility of the adjust TMJ pressure treatment and to reach a conclusion on the different~     treatments for different types of TMD, and determine the new serial treatment of~     temporomandibular disorders.~   "
200936|NCT00932581|"~     The purpose of this study is to examine whether scores on questionnaires that rate how much~     Parkinson's Disease (PD) has slowed movements of the body differ when the order of the~     questions are changed. The consistency and accuracy of the questionnaires will also be~     examined. It is hypothesized that there will not be a difference.~   "
200937|NCT00932555|"~     The aim of this international prospective post-marketing surveillance study is to obtain data~     on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE~     Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.~   "
200938|NCT00932542|"~     Assess the efficacy and safety of the topic use of an eutectic mixture of local anesthetics~     for postoperative pain control of patients submitted to hemorrhoidectomy. Patients will be~     operated and discharged at the same day in a day hospital clinic. During the fourteen days~     recovery period, they will apply the study medication to the anal region 4 times daily. The~     Visual Analog Pain Scale (VAS) will be answered twice daily. Patients will also take 100 mg~     oral nimesulide twice daily and 50 mg tramadol on demand up to 4 times daily. The tramadol~     demand will be tabulated. A rescue medication for analgesia will be provided (sodium~     diclofenac IM).~   "
200952|NCT00932360|"~     Fibromyalgia as a clinical syndrome is defined by chronic widespread muscular pain, fatigue~     and tenderness with hyperalgesia to pressure over tender points. Pain associated with~     fibromyalgia can interfere with daily function, work, and social activities. Thus, one of the~     main treatments for patients with fibromyalgia must focus on pain relief to allow the person~     to function more independently both at home and at work. Although the etiology of~     fibromyalgia is unknown, there is clearly enhanced sensitization in the central nervous~     system pain pathways as demonstrating by decreases in pressure pain thresholds, reduced~     central inhibition, and enhanced temporal summation. Reducing pain in people with~     fibromyalgia would help increase the patient's ability to return to work, perform activities~     of daily living and thus improve the quality of life for the patient. Transcutaneous~     electrical nerve stimulation (TENS) is a modality utilized in physical therapy that delivers~     electrical stimulation through the skin and is used for both acute and chronic pain. TENS~     works by reducing central excitability and increasing central inhibition. Thus, the~     investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation~     (TENS) to patients with Fibromyalgia (FM) will reduce pain, reduce central excitability by~     restoring diffuse noxious inhibitory controls (DNIC), and reduce temporal summation and that~     this decrease in pain and/or central excitability will improve function. The primary aim of~     the study is to test the effectiveness of TENS on pain and central excitability in a~     crossover design study for patients with Fibromyalgia with random assignment to three~     treatments: no treatment control, placebo TENS and active high frequency TENS. A secondary~     aim is to test the effect of decreased pain and central excitability on function in patients~     with Fibromyalgia.~   "
200939|NCT00932529|"~     Despite different pharmacological properties, the scientific evidence is inconclusive~     regarding which of the first-line second generation antipsychotics (SGAs) should be preferred~     for the individual patient suffering from psychosis. The limitations of the evidence base may~     be related to the highly selected samples, short duration, and rigid experimental designs of~     most randomized clinical trials of efficacy. Moreover a high proportion of the clinical~     trials are drug company sponsored which could introduce funding bias. The purpose of this~     non-commercially funded study is to investigate whether effectiveness differences exist among~     the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are~     used in a representative clinical setting. Eligible patients are those admitted to hospital~     for acute psychosis and candidates for oral antipsychotic treatment. The investigators~     hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse~     sample representative of most patients admitted for symptoms of acute psychosis, differential~     effectiveness among the SGAs could be disclosed when the patients are followed for up to 2~     years. This could deliver valuable information regarding which SGA should be the starting~     antipsychotic drug in order to facilitate the most beneficial outcome.~   "
200940|NCT00932516|"~     The purpose of this study is to examine the effectiveness of the South Beach Diet™ and South~     Beach Diet™ products compared to a traditional calorie restricted diet.~   "
200941|NCT00932503|"~     The aim of this study was to ascertain if the use of Vicryl plus® reduced the number of wound~     infections after transverse laparotomy comparing to polydioxanon suture.~   "
200942|NCT00932490|"~     The primary aim of study is to:~        1. Test the effectiveness of a tailored protocol in promoting adherence to oral~          chemotherapeutic agents in adults receiving a new oral chemotherapeutic agent for~          breast, colorectal, GIST, renal cell,and hepatocellular cancers.~           Exploratory Aims:~        2. Examine adherence to oral chemotherapeutic agents over time at 2, 4 and 6 months in a~          sample of breast, colorectal, GIST, renal cell,and HPCC cancers patients.~        3. Examine the effects of age, gender, caregiver availability, personal involvement in~          health care, and depression on adherence to oral chemotherapeutic agents.~   "
200943|NCT00932477|"~     The safety and tolerability of two new artificial tears will be compared to a~     currently-available artificial tear in subjects with dry eye. Each subject will receive all~     three products in a randomly assigned order. The subject will use one product at a time for a~     duration of one week before switching to the next assigned product.~   "
200944|NCT00932464|"~     This study is being conducted to see if neratinib is absorbed, distributed, or eliminated~     differently when administered in the fasting state versus after a high-fat meal.~   "
200945|NCT00932451|"~     This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients~     with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene.~     This trial will also allow patients from a Phase 3 trial who received standard of care~     chemotherapy (Study A8081007) to receive PF-02341066.~   "
200946|NCT00932438|"~     This is a multicentre, open labeled, controlled phase study designed to assess effectiveness~     of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the~     treatment of unresectable liver metastases in patients with colorectal cancer.~   "
200947|NCT00932425|"~     Atrial fibrillation (AF) is a common and treatable cause of ischemic stroke, but it can be~     paroxysmal and asymptomatic, and therefore difficult to detect. Patients with stroke~     routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke~     as a means of excluding AF. Small studies indicate that extending the duration of monitoring~     with portable outpatient telemetry devices detects more cases of AF. However, these studies~     are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring~     detects more cases of AF than routine clinical follow-up. The investigators therefore propose~     a pilot study to determine the feasibility of randomizing patients to prolonged cardiac~     monitoring or routine clinical follow-up. The investigators will enroll 40 consecutive adult~     patients seen at the University of California at San Francisco (UCSF) Neurovascular service~     with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater). Enrolled patients will~     be randomized in a 1:1 fashion. Group A will be assigned to wear an ambulatory cardiac event~     monitor for 21 days. Group B will be discharged home without a monitor and will serve as~     controls during routine clinical follow-up. The investigators' primary outcome will be~     feasibility, defined as more than 80% of randomized patients completing full clinical~     follow-up and more than 70% of cardiac monitoring if applicable. The investigators' secondary~     outcomes will be diagnoses of AF at 90 days and 1 year and diagnoses of recurrent stroke at 1~     year.~   "
200948|NCT00932412|"~     This study is a phase II randomized multicenter study. Patients will be enrolled at time of~     diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without~     indication of intensification by allogeneic stem cell transplantation and/or without HLA~     (Human Leukocyte Antigen)-compatible donor, who attain a CR after one or two cycles of~     induction chemotherapy, will be eligible for the study Clofarabine / Intermediate-Dose~     Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC)and will be randomized between 3 courses~     of CLARA chemotherapy and 3 courses of HDAC chemotherapy as consolidation.~      We will compare efficacy and toxicity among the two arms.~   "
200949|NCT00932399|"~     The purpose of this study is to assess weight change in a population of Veterans with~     amputations. Little is known about the how weight changes following an amputation. It is~     widely believed that many patients experience weight gain following amputation. This study~     aims to identify magnitude of weight changes following amputation and determine~     characteristics associated with weight gain. Information on weight change trajectories would~     be useful to better understand long-term health consequences associated with amputation and~     to design and target interventions to encourage weight maintenance and general health~     promotion for groups at high risk of weight gain.~   "
200950|NCT00932386|"~     This study is being done to determine if the drug known as dexmedetomidine improves the way~     we care for patients when their surgery involves the use of a tourniquet on the leg. A~     tourniquet is sometimes used for lower leg or foot surgery to decrease the blood loss for the~     patient and to make it easier for the surgeon to do his work.~   "
200953|NCT00932347|"~     The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis~     extracts on oral malodor and gingival inflammation in gingivitis subjects.~   "
200954|NCT00932334|"~     Title: Culturally tailored behavioral interventions to enhance living kidney donation/living~     kidney transplantation Applicants: Johns Hopkins Medical Institutions, National Kidney~     Foundation of Maryland Principal Investigator: Neil R. Powe, MD, MPH, MBA Address: 2024 E.~     Monument Street, Suite 2-600, Baltimore, MD, 21205 Phone: 410-955-6953; Email:~     npowe@jhmi.edu; Fax: 410-955-0476 Rates of kidney donation have been largely stagnant for the~     past 10 years, resulting in large imbalances in numbers of persons on transplant waiting~     lists and the number of persons receiving kidney transplants. Slow improvement in donation~     and transplantation rates are exacerbated by ethnic/racial disparities in kidney transplants,~     in which minorities, particularly African Americans, are far less likely to receive deceased~     kidney transplants. Although living related kidney donation (LD) offers patients an~     opportunity to bypass many barriers contributing to disparities in kidney transplantation~     (e.g. waiting lists and immunological incompatibility issues), African Americans remain less~     likely to receive living related kidney transplants (LRT), further exacerbating disparities~     in transplant rates. Recent research demonstrates many ethnic minorities desire kidney~     transplantation, but rates of patient-physician and patient-family discussions regarding~     LD/LRT are suboptimal. Compared to Whites, African Americans have also been shown to have~     disproportionately greater rates of culture-specific concerns (such as mistrust in health~     care) that could impede them from seeking important medical therapies. It is unknown whether~     culturally tailored behavioral interventions to enhance patient/family decision-making~     regarding LD/LRT before the onset of end stage renal disease could improve rates of LD/LRT or~     could narrow racial disparities in the receipt of transplantation. The primary goal of this~     proposal is a) to use focus group methodology to develop culturally tailored educational~     materials for patients/families considering LD/LRT and b) to perform a randomized controlled~     trial to test the effectiveness of a culturally tailored social-worker led intervention~     (using established behavioral problem-solving therapeutic techniques) in enhancing rates of~     family communication, donor evaluations, and transplantation. The substantial experience of~     our consortium, including the National Kidney Foundation of Maryland and the Johns Hopkins~     Medical Institutions (Welch Center and the Medical Surgical Transplant Services in the School~     of Medicine), in the evaluation/ implementation of donor/recipient educational programs as~     well as the conduct of behavioral, epidemiologic and interventional studies related to~     donor/recipient health and psychology provides a strong foundation for the conduct of this~     study.~   "
200955|NCT00932321|"~     This is a comparative study. The primary objective of the study is to assess the efficacy of~     a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to~     assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol~     (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the~     safety and tolerability of the product.~   "
200956|NCT00932308|"~     The investigators are involved in a research program to understand how different diets may~     affect the risk of colorectal polyps and cancer. To that end, the investigators are~     conducting a study of a western style diet versus a prudent style diet in which volunteer~     subjects are provided a different diet for 2 separate 4 week periods at the Rockefeller~     University Hospital. During one of these 4 week inpatient periods they receive a Western~     style diet and during the other 4 week inpatient period they receive a Prudent style diet.~     The investigators will determine changes within the colon as a result of the two different~     diets. A more detailed description of the study is provided below.~   "
200957|NCT00932295|"~     The study's aim is to develop a clinical model that can be used to measure the nicotine~     delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that~     are marketed as a means to deliver nicotine to cigarette smokers. The study will compare the~     nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two~     devices currently marketed in the U.S.: Crown Seven and NJOY. Specifically, the effects of~     these devices will be compared with the effects of own brand cigarettes (positive control),~     and an abstinence condition (sham smoking; puffing from an unlit cigarette). The primary~     hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of~     electronic devices marketed as a means to deliver nicotine to smokers can be measured during~     a period of acute exposure.~   "
200958|NCT00932282|"~     The purpose of this study is to determine whether the addition of anti-IgE treatment will~     make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut~     allergy.~   "
200959|NCT00932269|"~     This is a randomized cross-sectional study of the Swedish population. Blood samples will be~     collected from a subpopulation in order to estimate the age specific sero-prevalence of the~     Swedish population for diseases included in the National Immunization Program (NIP), and to~     affirm the population's protection against polio. To be able to recommend complementary~     immunizations to immigrated children, a sub study focusing on foreign born teenagers will~     also be done and compared to children of the same age born in Sweden.~   "
200960|NCT00932256|"~     MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small~     amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug~     treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). The phase~     1 single-dose trial will consist of 21 subjects: 1) to gather pharmacodynamic measurements~     and blood levels of active ingredients over 12 hours; 2) To report subjective scores by~     subjects rating efficacy of single dose of STAHIST; 3) To report any side effects or adverse~     drug reactions and rate the severity of incidence.~   "
200961|NCT00932243|"~     The presence of bacteremia and sepsis in percent of critically ill patients and none at all,~     associated with different expression and faction of Toll-Like-Receptors (TLRs.~   "
200962|NCT00932230|"~     This study examines the effect of kinesiology tape on proprioception and postural control in~     subjects with sub-acute and chronic ankle sprains/strain.~   "
200963|NCT00932217|"~     To evaluate the difference in the incidence of febrile episodes in patients undergoing stem~     cells mobilization with chemotherapy and filgrastim versus chemotherapy and lenograstim.~      A febrile episode will be considered as: body temperature > 38°C for two measurements in the~     24 hours with an interval of 6 hours at least between the two measurements.~   "
200964|NCT00932204|"~     The purpose of the present study was to investigate possible therapeutic effects and safety~     of sequentially combined low-frequency repetitive transcranial magnetic stimulation (rTMS) to~     the right dorsolateral prefrontal cortex (DLPFC) and supplementary motor area (SMA) in~     patients with treatment-resistant obsessive-compulsive disorder (OCD).~   "
200965|NCT00932191|"~     The purpose of this study is to compare two cataract surgical technique variations for~     removing the nucleus of the lens (central part of the lens) in terms of damage to the inner~     layer of the cornea which is called the endothelium. One variation uses more ultrasound~     energy and the other more mechanical force to break up the nucleus.~   "
200966|NCT00932178|"~     Calmer Life is a research study for older adults with anxiety. In the program participants~     will have the opportunity to learn skills that may help cope with anxiety. Participants have~     the option of including religion and spirituality into the skill. Skills participants can~     learn include: how to relax, how to change the way you think about things, and how to solve~     problems more effectively.~   "
255487|NCT00206674|"~     The purpose of this study is to evaluate if Leukine can induce clinical response or remission~     in patients with Crohn's disease.~   "
200975|NCT00932061|"~     The hypothesis of this study is that biological markers are present in the body that are good~     indicators of chronic pain. Eligible participants will be assessed at baseline and after~     receiving a series of acupuncture or sham acupuncture (something that resembles, but is~     not, active acupuncture) sessions. If the subject qualifies for the investigators' research~     and are subsequently enrolled in this study, they will be randomly assigned (like the flip of~     a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to~     improvements in both clinical and evoked pain associated with fibromyalgia. The study~     involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at~     the end of the study. Another optional portion of the study would involve 2 PET (positron~     emission tomography) scans of the subject's brain, one at the beginning and one at the end of~     the study; this type of scan allows us to get more specific information about the subject's~     brain function during an acupuncture session.~   "
200976|NCT00932048|"~     Type 2 diabetes mellitus significantly increases the risk for the development of~     atherosclerosis. Recently, atherosclerosis imaging with 18F-FDG PET (18F-Fluorodeoxyglucose~     Positron Emission Tomography) is useful for tracking inflammation within plaque and~     monitoring the response to drug therapy~      The purpose of this study is to determine whether FDG-PET is capable of detecting~     atherosclerotic vascular inflammation and monitoring the early effects of statins in type 2~     diabetic patients. The usefulness of FDG-PET in risk stratification is also investigated.~   "
200977|NCT00932035|"~     This pilot phase I and randomized phase II trial studies the best way to perform axillary~     lymph node preservation surgery and to see how well it works in preventing lymphedema in~     patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast~     cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary~     lymph node dissection is more effective than standard axillary lymph node dissection in~     preventing lymphedema.~   "
200978|NCT00932022|"~     This study evaluated the effectiveness of trospium chloride extended release (XR) in obese~     female patients with overactive bladder (OAB). Patients received either placebo and trospium~     chloride XR or placebo only. The study assessed the change from baseline in urinary~     frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The~     study was 14 weeks in duration.~   "
200979|NCT00932009|"~     The purpose of this study is to determine the prevalence and type distribution of genital~     human papillomavirus (HPV) infection in Tanzanian men.~   "
200980|NCT00931996|"~     DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control~     and spatial cognition are well-established deficits in schizophrenia. However, the regional~     disturbances in brain function causing these deficits are not yet known. This application~     proposes a series of integrated behavioral studies designed to identify causes of deficits in~     schizophrenia.~   "
200981|NCT00931983|"~     --Participation open to all Canadian residents--~      The purpose of this study is to address how well children with incomplete spinal cord~     injuries of greater than 12 months duration who remain non-functional ambulators improve~     through body weight assisted treadmill training (BWATT).~   "
200982|NCT00931970|"~     The purpose of this study is:~      1. to compare complications and mortality of hemodialysis with those of peritoneal dialysis~     in Korean end stage renal disease (ESRD) patients; 2. to analyze the treatment effects on~     quality of life (QOL) by dialysis modality; and 3. to analyze cost-effectiveness by dialysis~     modality.~   "
200983|NCT00931957|"~     The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions~     of Behcet's Disease treated with Methotrexate and Prednisolone~   "
200984|NCT00931944|"~     This is an open-label, multi-center study designed to extend the evaluation of the safety,~     tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.~   "
200985|NCT00931931|"~     Patients with relapsed solid tumors such as sarcomas and neuroblastoma have a poor survival,~     generally < 20%. There is an urgent need for new treatments that are safe and effective.~      HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the~     RL1 gene which encodes the protein ICP34.5, a specific determinant of virulence. Mutants~     lacking the RL1 gene are capable of replication in actively dividing cells but not in~     terminally differentiated cells - a phenotype exploited to selectively kill tumor cells. In~     previous clinical studies, HSV1716 has been shown to be safe when injected at doses up to~     10^5 plaque forming units (pfu) directly into human high-grade glioma and into normal brain~     adjacent to tumour, following excision of high-grade glioma. In an extension study, HSV1716~     has been shown to be safe when injected at a dose of up to 10^6 pfu directly into brain~     tumours. Replication of HSV1716 in human glioblastoma in situ has been demonstrated.~     Following a single administration of HSV1716 by direct injection into active recurrent tumor~     or brain adjacent to tumor, some patients have lived longer than might have been expected.~     This study seeks to evaluate the safety of a single injection of HSV1716 in the treatment of~     extracranial solid tumors in adolescents and young adults.~      HSV1716 has also proved safe when given by direct intra-tumoural injection in patients with~     squamous carcinoma of the head and neck, and in patients with malignant melanoma.~      Replication of HSV mutants in human sarcomas and neuroblastoma in cultured cells and human~     xenograft models has been demonstrated.~      This study is designed in two parts. PART 1 of the study specifies a single dose of virus.~     Participants who experience at least stable disease or relapse following a determination of~     stable disease, may qualify for subsequent doses in PART 2. PART 2 requires signing of a~     separate consent.~      Funding Source - FDA OOPD~   "
200986|NCT00931918|"~     This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without~     VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse~     Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to~     RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.~   "
200987|NCT00931905|"~     Saturnism, or lead poisoning, is defined by clinical symptoms (affecting primarily the~     nervous, hematopoietic, gastrointestinal, cardiovascular, musculoskeletal, renal and~     reproductive systems) compatible with exposure, in the short or long term, to lead or to its~     compounds, and can manifest as acute or chronic symptoms, pursuant to the intensity and~     duration of the signs and symptoms. Measuring serum concentration is the primary method for~     diagnosing and accompanying exposed workers. Presently, elevated lead counts are reversed by~     using drugs whose effectiveness is contested on various fronts. Experimental studies shows~     the efficacy of homeopathic preparations in controlling blood lead levels in laboratory~     animals, creating the need for controlled studies that evaluate the effectiveness and safety~     of these preparations in humans.The objective of this study was evaluate the effectiveness of~     the homeopathic preparation Plumbum metallicum in reducing the blood lead level of workers~     exposed to this metal.~   "
201291|NCT00927875|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923~     administered in combination with carboplatin and etoposide followed by BMS-833923 alone in~     subjects with extensive-stage Small Cell Lung Cancer (SCLC).~   "
200988|NCT00931892|"~     1. The purpose of this research study is to evaluate non-invasive markers of celiac disease~          activity in subjects that are on a gluten-free diet, in remission from celiac disease~          who undergo gluten challenge.~        2. The secondary aims of this protocol are to identify novel mediators important in the~          pathophysiology of celiac disease and to evaluate changes in metabolism with gluten~          exposure.~   "
200989|NCT00931879|"~     The objective of this study is to determine the efficacy of 6 months of 4 g/day oral Lovaza®~     on endothelial-dependent and heat-induced vasodilation in type 2 diabetics with neuropathy~     and elevated triglyceride levels. Omega-3 fatty acids appear to exert beneficial effects on~     vascular function that are independent of the changes in serum triglycerides. The efficacy~     will be compared with a placebo given at the same duration. Efficacy of the drug will be~     evaluated after 3 and 6 months of treatment. This timeline should be adequate for evaluation~     of the primary neurophysiological endpoints. Previously, the investigators have demonstrated~     that it is feasible to pharmacologically alter nerve fiber density in as little as 18 weeks~     and that this correlates with subjective and objective measures of neurovascular function.~     The investigators are predicting an enhancement of post-ischemic hyperemia of the foot~     dorsum, where the dilative mechanism is primarily endothelium-dependent and a similar~     improvement in heat-induced hyperemia.~   "
200990|NCT00931866|"~     The primary purpose of this study is to assess the effectiveness of once daily application of~     a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when~     applied to the painful area.~   "
200991|NCT00931853|"~     Primary Objective:~        -  To evaluate the clinical efficacy of Naturetti (jelly sugar free)~        -  To test medication on subjects who suffer chronic functional constipation in 30 days~          use.~      Secondary Objectives:~        -  To demonstrate the clinical tolerability when daily used (repeated doses) of the~          components of the study drug. The components will be evaluated by the adverse events~          occurrence classified by possibly related, probably related and definitely related~        -  To demonstrate the clinical tolerability of the study medication by the continuous use~          during the second phase study~        -  To identify any adverse events related to the study drug~        -  To identify any drug interaction.~   "
200992|NCT00931840|"~     This is a Phase 2, multicenter, multiple-arm, open-label study to evaluate the efficacy,~     safety, and tolerability of EZN-2208. EZN-2208 will be administered as a single agent in~     patients with K-RAS mutations in the tumors. Patients with wild type K-RAS in tumors will be~     randomized to EZN-2208 + cetuximab or to standard of care (Camptosar® + cetuximab), patients~     must have failed regimens containing irinotecan (Camptosar®, CPT-11), oxaliplatin~     (Eloxatin®), and fluoropyrimidine.~      After discontinuation of study treatment, patients will receive care as considered~     appropriate by the investigator. Patients will continue to be followed for disease~     progression, subsequent anticancer therapy, and survival.~   "
200993|NCT00931827|"~     The study examines the use of Mirena or Implanon for long-term contraception in women. The~     duration of therapy use is the key focus of the study. Also, any reasons for discontinuation~     and the safety profile will be examined. In addition, patients are asked to fill out a short~     questionnaire about their menstrual bleeding before and during therapy.~   "
200994|NCT00931814|"~     The purpose of this study was to investigate the effects of 8-week exercise training on~     depression symptoms, physical functions, and quality of life in the community-dwelling~     elderly.~   "
200995|NCT00931801|"~     The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and~     satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen~     for participants fully suppressed on an atazanavir/ritonavir based highly active~     antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several~     pharmacologic factors support this concept including the favorable drug interaction between~     atazanavir and raltegravir. Participants will be randomized to either continue on their~     current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus~     raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice~     daily). Participants will be followed for 48 weeks for safety, tolerability, and~     satisfaction. After baseline, the participants will have six clinic visits for evaluation and~     labs.~   "
200996|NCT00931788|"~     People who have had a stroke or transient ischemic attack (TIA or mini-stroke) are at high~     risk of having another stroke or a heart attack. Conditions like high blood pressure and high~     cholesterol, along with other lifestyle behaviors (e.g., smoking), substantially increase the~     risk of stroke and heart disease. Aggressive treatment of these risk factors however, can~     significantly reduce the chance of another stroke, heart attack or death.~      This study will look at different ways to optimize blood pressure and cholesterol levels and~     educate people about positive lifestyle changes.~   "
200997|NCT00931775|"~     The purpose of this study is to examine whether the speed of the clinical antidepressant~     action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day,~     tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.~   "
200998|NCT00931762|"~     This study will assess the safety and efficacy of Panobinostat as a single agent in the~     treatment of Primary Myelofibrosis, Post-Polycythemia Vera and Post-Essential~     Thrombocythemia. There will be two cohorts - patients with JAK2 mutation and patients without~     JAK2 mutation.~   "
200999|NCT00931749|"~     The purpose of this study is to determine the effects of low intensity ultrasound therapy~     over the cartilage morphology (thickness and volume) of patients with mild or moderate knee~     osteoarthritis.~   "
201021|NCT00931437|"~     Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9)~     and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in~     green vegetables. A new dairy product is developed containing both vitamin K1 and~     K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from~     such a mixture is not known. In this study the absorption profile of phylloquinone and~     menaquinones from this new dairy product containing several K-vitamins is investigated. This~     study describes a dietary intervention experiment for one single cocktail containing several~     K-vitamins as part of a dairy product.~   "
201022|NCT00931424|"~     A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive~     surgery on Primary Chronic Venous Insufficiency.~   "
201000|NCT00931736|"~     On a global scale, tuberculosis (TB) is the single most important infectious cause of~     morbidity and mortality. The World Health Organization has estimated that one-third of the~     entire world's population carries latent TB infection. A key TB control strategy is therapy~     of latent TB infection (LTBI). The current standard regimen is 9 months of Isoniazid (9INH).~     This regimen has excellent efficacy if taken regularly, but its effectiveness is~     substantially reduced by poor compliance. Serious side effects, such as hepato-toxicity can~     occur. Three shorter alternatives have been recommended: 6 months INH (6INH), 2 months~     Rifampin - Pyrazinamide (2RIF-PZA) and 4 months Rifampin (4RIF). The regimen of 6INH is less~     efficacious than 9INH, while 2RIF-PZA has been largely abandoned because of serious toxicity.~     Based on some evidence in treatment of LTBI, and extrapolating from extensive experience with~     treatment of active TB, it is believed that 4RIF has similar efficacy as 9INH. Therefore, the~     investigators are initiating the first multi-site international randomized trial that will~     compare the effectiveness of 4RIF and 9INH in preventing active tuberculosis.~   "
201001|NCT00931723|"~     The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added~     to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in~     treating acute mania and if so, how it compares with placebo (a non-active capsule, like a~     sugar pill, that looks like lithium).~   "
201002|NCT00931710|"~     This study will compare the antihypertensive efficacy and safety of a~     valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2~     systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and~     less than 200 mmHg).~   "
201003|NCT00931697|"~     Mefloquine is a quinolinemethanol antimalarial that is effective as therapy and prophylaxis~     for all species of malaria infecting humans, including multi-drug resistant Plasmodium~     falciparum. The marketed anti-malaria drug consists of two enantiomers of mefloquine.~      Mefloquine's clinical utility has been impaired by its association with neuropsychiatric side~     effects. The pharmacological basis of mefloquine's side effects is not known but two of the~     most reported hypotheses relate to its action on (i) the adenosine receptor and (ii) its~     effect on the cholinesterase enzyme. For both of these mechanisms, there is a significant~     stereoselective activity of the two enantiomers. In vitro studies show that the (-) isomer is~     50-100 fold more potent towards adenosine receptors compared with the (+) isomer. In~     addition, (-)-mefloquine has considerably more anti-cholinesterase activity. It has therefore~     been hypothesised that (+)-mefloquine may have a better central nervous system (CNS) safety~     profile compared with either the racemate or (-)-mefloquine.~      This study is a randomized, ascending dose, double-blind, active and placebo-controlled,~     parallel group study in healthy male and female volunteers designed to investigate this~     hypothesis and to describe the comparative pharmacokinetics of the racemate and the single~     enantiomer.~   "
201004|NCT00931671|"~     The study is designed to investigate (1) the effects of task-oriented aerobic exercise~     training on cardiorespiratory fitness, cerebral blood flow, oxygenation, functional~     performance, and physical activity in patients with chronic stroke. (2) the association~     between outcomes~   "
201005|NCT00931645|"~     Phase III trial evaluating the role of autologous stem cell transplantation in previously~     untreated patients under 65 years with stage B and C B-cell chronic lymphocytic leukemia.~      Endpoints of the trial :~        -  major : progression free survival at 3 years~        -  secondary : overall survival, tolerance, prognostic factors according to baseline~          clinical stage and biological characteristics (IgHv mutational status, expression of~          ZAP70 and CD38, cytogenetics).~   "
201006|NCT00931632|"~     This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will~     attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive~     pressure support at any point during days 5 to 14 after birth may benefit from treatment with~     iNO.~   "
201007|NCT00931619|"~     Objective: To study the relative balance of GABA (A) binding potential and glutamate~     utilization in subjects with localization-related epilepsy with and without depression,~     subjects with major depressive disorder alone, and in subjects with generalized epilepsy~     (expected not to have significant comorbid depression). Pilot data shows that GABA(A) binding~     potential and glutamate utilization are tightly coupled in healthy subjects particularly in~     the mesial temporal lobe. We hypothesize that subjects with epilepsy will not exhibit the~     same degree of coupling, and that subjects with both epilepsy and depression will exhibit an~     even more pronounced decoupling.~      Study Population: Subjects aged 18-55 with localization-related epilepsy with and without~     depression, subjects with generalized epilepsy, subjects with major depressive disorder (MDD)~     alone, and healthy controls.~      Design: This is a neuroimaging study, using positron emission tomography (PET) with~     [11C]flumazenil, to measure GABA(A) binding potential, and [18F]fluorodeoxyglucose, to~     measure glucose utilization (reflective of neuronal glutamate release) Magnetic resonance~     spectroscopy (MRS), will be used to measure GABA and glutamate in the mesial temporal cortex,~     and corroborate the PET results. Structural magnetic resonance images (MRI) will be obtained~     for MRS localization and partial volume correction of PET images.~      Outcome measures: The binding potential of GABA(A), the regional rate of glucose metabolism,~     and the levels of GABA and glutamate as measured by MRS. Patients will be stratified by~     seizure type and depression ratings.~   "
201008|NCT00931606|"~     Anemia can be caused by the chemotherapy treatment that is used to treat metastatic breast~     cancer. This study will be used to find out if ACE-011 can help treat chemotherapy induced~     anemia in patients with metastatic breast cancer.~   "
201009|NCT00931593|"~     Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of~     gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in~     healthy volunteers. They are induced by meal.~      The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.~      Esophageal high resolution manometry with solid state sensors was developed in the 90s. The~     examination is easier and more accurate than perfused manometry. The aim of this study is to~     validate in healthy volunteers the use of high resolution manometry (Sierra Scientific~     Instruments, California CA) to detect tLESr.~   "
201010|NCT00931580|"~     While a large percentage of children have low blood vitamin D levels, the significance of~     these low levels and the impact on health is unclear. The purpose of this project is to~     determine the effects of varying doses of vitamin D supplementation over 12 weeks on blood~     indicators of health in white and black children, aged 9 to 13 years, from both the northern~     and southern US.~   "
201011|NCT00931567|"~     This study is a clinical, multicentric, randomised open trial. The objective is to evaluate~     the efficiency, in terms of wound healing speed, of peroperative application of autologous~     platelets gel versus standardized wound dressing. The wound Healing model used in this study~     is the  open palm  surgical treatment of Dupuytren's disease.~      Dupuytren's disease is a fibroproliferative disease of the palmar and digital fascia of the~     hand that may lead to a fixed flexion contracture of the fingers.~      The main indication for surgery is the loss of finger extension. In some cases of palmar~     Dupuytren's disease the surgical removal of diseased tissues may lead to a cutaneous loss of~     substance ( open palm technique ). This loss of substance is treated using vaseline~     dressing and the wound healing is obtained in 4 weeks.~      Autologous platelets gel (Platelet Rich Fibrin) is obtained from the patient's own blood.~     Some recent studies have shown that it speeds up the wound healing and enhances the quality~     of the scar.~      PRF belongs to a new generation of autologous platelet gel that are easily obtained after~     centrifugation of patient's own blood.~      The Platelet Rich Fibrin (PRF) contains many wound healing factors : Three pro inflammatory~     cytokines ( IL1,IL6, TNF-alpha) , one anti-inflammatory cytokine (IL4) and a growth factor~     (VEGF).~      The study will be running on 60 days, starting from the operation day. The wound healing~     evaluation will be achieved at day1, day2, day7, day14, day 21 day 28 and day 60.~      The inclusion criteria are : age over 18, Dupuytren's disease with an indication of surgical~     treatment using the open palm technique, patients having signed the agreement form.~      80 patients will be included in the study and divided into 2 groups . The first group of~     patients will receive PRF and the other group will receive vaseline dressings.~      The speed and the quality of wound healing will be compared.We will also compare the number~     of patients with a complete wound healing at day 21 . Moreover,we will evaluate the pain~     during the dressings' change and the bleeding of the palmar wound.~      For the wound healing speed , a difference of 7 days between the two groups will be~     considered as statistically significant.~      Statistical analysis will be achieved using Chi2 test and Logrank test.~   "
201012|NCT00931554|"~     Despite a substantial decrease in postoperative mortality, morbidity after pancreatic~     resections is still high, even at high-volume centers. It has been recently suggested that~     early removal of postoperative drainages is associated to a decreased rate of intra-abdominal~     complications, with particular regard to pancreatic fistula. Furthermore, our research group~     demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a~     cardinal role in predicting the developement of abdominal complications, including pancreatic~     fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were~     considered at low risk of fistula. Therefore, the investigators designed a randomized~     prospective trial on early (postoperative day 3) versus standard (postoperative day 5)~     drainages removal after pancreatic resections in patients at low risk of developing~     pancreatic fistula (AVD < 5000 IU/L in postoperative day 1) to test whether drainages per~     se influence postoperative complication rates and to eventually validate a fast-track policy~     in pancreatic resections.~   "
201013|NCT00931541|"~     The aims of the study are to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of AZD6088 following single ascending dose administration in healthy male~     and non-fertile females.~   "
201014|NCT00931528|"~     RATIONALE: Tadalafil may help prevent erectile dysfunction (ED) in patients with prostate~     cancer that has been treated with radiation therapy. It is not yet known whether tadalafil is~     more effective than a placebo in preventing erectile dysfunction.~      PURPOSE: This randomized phase III trial is studying tadalafil to see how well it works~     compared with a placebo in preventing erectile dysfunction in patients with prostate cancer~     treated with radiation therapy.~   "
201015|NCT00931515|"~     The NuBac device is indicated for reconstruction following nucleotomy in skeletally mature~     patients at least 18 years of age with symptomatic single level degenerative disc disease~     (DDD) at L4/L5 only.~      DDD is defined as discogenic back pain with or without leg pain; with degeneration of the~     disc as confirmed by patient history, physical examination, radiographic studies showing:~     decreased disc height, contained herniated nucleus, vacuum phenomenon (dark disc) OR positive~     discography at the affected level.~      These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level~     and should have failed at least six months of conservative, non-operative care.~      Demonstrate non-inferiority compared to ProDisc.~   "
201016|NCT00931502|"~     The purpose of this study is to better understand what treatment methods result in the best~     outcomes for patients who have heart attacks due to blood clots forming within stents.~   "
201017|NCT00931489|"~     The investigators hope to determine if wet AMD patients differ from patients with dry AMD~     or normal eyes in the production of anti-retinal pigment epithelium (anti-RPE) or~     anti-retinal antibody formation. To explain: the immune system can make antibodies that~     attack our own cells, specifically the RPE and the retina. Normally the RPE and retinal cells~     are ignored by the immune system, but when disease occurs, immune reactions can occur, making~     an autoantibody that can attack the patient's own cells and make things worse. This~     production of autoantibodies that react with our own RPE and retinal cells is what the~     investigators want to test in this proposal to see if they may contribute to, or are~     responsible for, a poor response to treatment.~      The investigators also want to know how those patients who initially respond to the~     standard-of-care treatment, ranibizumab injections, differ in the production of anti-RPE or~     anti-retinal antibody formation, from those patients who do not respond initially after 4~     consecutive injections.~   "
201018|NCT00931476|"~     This trial was conducted in the United States of America (USA). The aim of this clinical~     trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian~     subjects, and to identify somatostatin-related adverse events.~   "
201019|NCT00931463|"~     The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI~     regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and~     2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and~     raltegravir.~      The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.~      The primary endpoint is virological: a comparison of virological suppression in plasma < 200~     copies/mL between the randomized arms after 48 weeks.~      Secondary and exploratory endpoints include virological, immunological, safety, clinical,~     metabolic, drug adherence, drug resistance and quality of life.~   "
201020|NCT00931450|"~     RATIONALE: Sunitinib malate and exemestane may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving sunitinib malate and exemestane before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     sunitinib malate to see how well it works when given together with exemestane in treating~     postmenopausal women with breast cancer.~   "
201033|NCT00931281|"~     The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of~     multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir~     in healthy volunteers.~   "
201034|NCT00931268|"~     The study is being undertaken to establish the effectiveness and safety of Macrolane volume~     restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks~     lipoatrophy.~   "
201023|NCT00931411|"~     Atopic dermatitis is one of the most frequent skin diseases. The disease is often worst~     during winter months when the skin is drier. Mild to moderate cases of atopic dermatitis are~     often controlled by a moisturizer alone. The use of moisturizers has been shown to have~     beneficial effects on atopic dermatitis. It can break the dry skin cycle by hydrating the~     upper layer of the skin which may prevent the recurrence of the disease and can reduce the~     use of cream or ointment medications such as corticosteroids. Formulation 609580 20 was~     developed to keep the moisturizing efficacy of formulation 609209 but to improve its~     tolerance and cosmetic acceptability (easier to apply, nicer texture, etc.). The new~     formulation contains the same quantity of shea butter and glycerin but in a different~     excipient (inactive substance) than the commercial product. In addition, vitamin B3 was added~     to see if it could help in reducing itching.~      The purpose of this study is to determine the safety and efficacy of two study products in~     children with atopic dermatitis. One of the study products (formulation 609580 20) is not~     commercially available (outside of clinical trials such as this one). The other study product~     (formulation 609209) has been approved in Canada and is currently available commercially~     under the trade name Lipikar Baume.~      For this study the child will be randomly assigned to one of the following two groups:~        -  Group 1: 50 children will receive formulation 609209, the commercial formula for 42 days~          and will receive formulation 609580 20, the new formula, for 14 days.~        -  Group 2: 50 children will receive formulation 609580 20, the new formula, for 42 days~          and will receive formulation 609209, the commercial formula, for 14 days.~   "
201024|NCT00931398|"~     The purpose of the proposed study is to determine the effectiveness of methylphenidate HCl~     (Concerta) in college students with ADHD. This study will consist of 110 college students~     between the ages of 18 and 25 who are enrolled full-time in a local or junior college. The~     study consists of an 8-week double-blind, placebo-controlled trial of placebo versus~     methylphenidate HCl (Concerta®) followed by a 10-week extension of open label methylphenidate~     HCl (Concerta®).~   "
201025|NCT00931385|"~     The study is intended to characterize the lung function profile of BI1744 in COPD patients~     where patients will perform pulmonary function tests at regular intervals for 24 hours at the~     end of a 6 week treatment period. Each patient will receive all four treatments.~   "
201026|NCT00931372|"~     The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase~     and improves second phase insulin response in subjects with diabetes mellitus type 2.~   "
201027|NCT00931359|"~     This is a prospective, multi-center, parallel, randomized, blinded study. The study has two~     groups, where in one study group the subjects receive treatment for axillary hyperhidrosis~     (excessive underarm sweating) with the DTS-G2 System in both axilla (treatment group). The~     other study group receives a sham treatment in both axilla where the subjects will have the~     same procedure performed but no energy from the device will be applied (sham group).~     Subjects will be randomized in a 2:1 ratio (treatment group: sham group).~      Subjects enrolled in the study will be blinded regarding which study group they are in. The~     study hypothesis is that subjects that receive the treatment will have a reduction in~     underarm sweating compared to those in the sham group, as measured by a quality of life~     questionnaire.~      All subjects will undergo follow up assessments at 14 days, 30 days, 3 months and 6 months~     post final treatment session. Subjects randomized to the treatment group will also have~     follow-up visits at 9 months and 12 months post final treatment session.~   "
201028|NCT00931346|"~     This study will evaluate the safety and acceptability of intermittent and daily pre-exposure~     prophylaxis (PrEP) regimens with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in HIV~     discordant couples, and it will directly compare adherence and intracellular drug levels in~     daily and intermittent PrEP recipients. It will also evaluate the relationship between drug~     adherence, sexual behavior and intracellular drug levels with an intermittent PrEP regimen.~     In addition it will evaluate the relationship between adherence to an intermittent PrEP~     regimen and timing of sexual activity in relation to PrEP dosing. The pilot will use~     objective medication event monitoring (MEMS) adherence measurement and evaluate the~     feasibility of newer adherence measurements such as hair sampling and plasma drug levels.~     This study will also evaluate the feasibility of using text messaging (SMS) to collect sexual~     activity data in an African setting. It will allow study teams and communities to prepare for~     potential subsequent larger trials of intermittent PrEP. The study is not sized to evaluate~     efficacy. If the intermittent PrEP regimen is safe, feasible in terms of adherence, and~     achieves intracellular drug levels similar to daily PrEP, the data could be used to design a~     larger phase 2 study with one or more intermittent PrEP regimens. The goal of such a larger~     trial would be to provide bridging data if daily PrEP regimens are found to be effective or~     to prepare for efficacy or non-inferiority trials of intermittent versus daily PrEP.~      Investigation of immune responses associated with FTC/TDF will also be evaluated in the pilot~     study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due to~     exposures that did not lead to established HIV infection, will be assessed at 2-3 time points~     and compared to responses in volunteers assigned to placebo. Immune responses may be~     correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type.~     As noted above, very few HIV infections are expected to occur during the study, so~     correlation of HIV-specific immune responses and protection from infection or attenuation of~     disease progression will not be possible until a larger study is conducted.~   "
201029|NCT00931333|"~     The macroporous calcium phosphate cement, MCPC, which composition is close to bone, is~     malleable and biocompatible, and has intrinsic radio opacity and good ability to undergo~     mechanical constraints. After the filling of the bone cavity, the cement hardens.~     Interestingly, this calcium phosphate cement has no exothermic hardening (on the contrary,~     the ordinary cements used nowadays cause necrotic lesions in tissues around during this~     phase) and favours vascularisation, cellular colonisation and bone healing. Thanks to its~     resorbability, the MCPC cement is replaced little by little by a physiologic bone. This last~     property is very important for young people needing a vertebroplasty after a traumatism.~      Thus, it will be tested in a low-invasive surgery, a non-percutaneous vertebroplasty,~     consisting in filling with the MCPC the body of the broken vertebra, after its stabilization~     thanks to 4 interpedicular screws. This protocol will be proposed to patients 1 to 3 weeks~     after the trauma having caused the fracture.~      The follow up will last 12 months with 5 visits (2 days, and 3, 4, 6 and 12 months after~     vertebroplasty), 2 CT scanners before inclusion and at 12 months, 2 EOS (ultra low dose~     imager replacing classical radiography) at 5 and 12 months, questionnaires (visual analogic~     scale for pain, and quality of life with OSWESTRY and SF36 scales) before inclusion and at 2~     days, and 3, 4, 6 and 12 months, and biological exams (CRP/VS, for inflammation) at each~     visit except 2 days after surgery. An osteodensitometry will be performed at 3 months.~   "
201030|NCT00931320|"~     An observational, non-interventional, multi-centre study to provide further information on~     the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.~   "
201031|NCT00931307|"~     The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a~     3-month period.~   "
201032|NCT00931294|"~     The hypothesis was that a one-year experience of choir singing once a week is more beneficial~     than group discussions to saliva concentration of testosterone.~   "
201035|NCT00931255|"~     The objective of this study is to evaluate the safety and efficacy of conversion from~     tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft~     function (DGF)and slow graft function (SGF) in improving graft function and delaying chronic~     allograft nephropathy. The investigators hypothesize that conversion from tacrolimus to~     sirolimus in renal transplant recipients with DGF/SGF in early months after surgery will~     improve graft function and decrease the progression of graft fibrosis.~   "
201036|NCT00931242|"~     The objective of this study is to evaluate the efficacy of apremilast in patients with~     recalcitrant atopic or contact dermatitis.~   "
201037|NCT00931229|"~     This is a single-arm study. Key eligibility criteria include (1) newly diagnosed, diffuse~     large B-cell or follicular cell non-Hodgkin's lymphoma; (2) negative test for hepatitis B~     surface antigen (HBsAg) and positive for antibody to hepatitis B core antigen (anti-HBc); (3)~     adequate bone marrow, liver, and kidney function. All eligible patients will receive~     rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy~     according to current treatment guidelines. The primary endpoint of this study is the~     incidence of hepatitis B virus (HBV) reactivation, defined by a greater than 10-fold~     increase, compared with previous nadir levels, of HBV DNA during rituximab-CHOP chemotherapy~     and within 1 year after completion of the last course of rituximab-CHOP chemotherapy.~     Patients who have HBV reactivation during the study period will receive free entecavir~     treatment, one of the standard treatment for chronic hepatitis B, for 48 weeks. The secondary~     endpoints include the incidence of hepatitis flare, defined as a greater than 3 fold increase~     of serum alanine aminotransferase (ALT) level that exceeded 100 IU/L, and the efficacy and~     safety of rituximab-CHOP chemotherapy.~      In the T1408 study we enrolled patients with newly diagnosed lymphoma who were HBsAg (-) and~     anti-HBc (+) and were to receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine,~     prednisolone)-based chemotherapy. Key findings of this study included (1) HBV reactivation,~     defined as a greater than 10-fold increase in HBV DNA compared with previous nadir levels,~     occurred to 10-20% of patients, depending on the sensitivity of the HBV DNA tests; (2) no~     HBV-related death with the prompt anti-viral therapy upon HBV reactivation; (3) patients with~     HBV reactivation were associated with poorer progression-free survival and overall survival;~     (4) serological breakthrough (i.e., re-appearance of HBsAg) is an important predictor of~     HBV-related hepatitis flare.~      In this amendment we will enroll more patients to clarify the above findings: (1) the~     association between HBV reactivation and survival; (2) diagnostic value of quantitative HBsAg~     and anti HBc tests on HBV reactivation; (3) whether host factors (DNA polymorphism) may help~     predict HBV reactivation. A larger patient cohort is needed to identify (1) baseline features~     that may help predict HBV reactivation, and (2) on-treatment features that may help timely~     anti-viral therapy.~   "
201038|NCT00931216|"~     This study seeks to determine the most effective way to reach and provide pregnant women with~     accessible, comprehensive, and high quality HIV care and treatment.~   "
201039|NCT00931203|"~     This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and~     preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end~     point is pathological complete response (pCR) rate. The secondary endpoints are toxicities of~     combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor~     response by magnetic resonance imaging (MRI), sphincter preservation rate, disease-free~     survival and overall survival.~   "
201040|NCT00931190|"~     The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial~     neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human~     papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV~     testing, as compared to cytology, to predict recurrence of high-grade CIN.~   "
201041|NCT00931177|"~     This is a study to evaluate the validity, reliability, and clinical usefulness of a new~     dehydration scoring system (DSS).~   "
201042|NCT00931164|"~     WHO: The investigators are recruiting children and young adults to participate in a research~     study who:~        1. Have been diagnosed with Alternating Hemiplegia of Childhood (AHC)~        2. Are between the ages of 6 months - 25 years old~        3. Have at least three 10-minute-long AHC episodes during a typical week~        4. Can commit to 12 weeks of completing of a daily log describing AHC episodes and to a~          multi-night hospital stay at the University of Utah Center for Clinical and~          Translational Science (CCTS)~      WHY: The goal of this study is to evaluate whether the study drug can safely and effectively~     decrease AHC episodes and improve the quality of life of individuals with AHC.~      WHAT and WHERE: This study involves at least 12 weeks of completing and submitting daily AHC~     Episode Logs and a five-day hospital stay at the University of Utah CCTS.~      There are 4 phases of the study, and they include:~        1. Six weeks of daily log completion prior to starting study drug~        2. Five day stay at the University of Utah CCTS~        3. Six additional weeks of daily log completion while using study drug at home~        4. One day clinic visit to the University of Utah for follow up~      COMPENSATION:~      There is no fee to participate. All procedures performed specifically for this study will be~     covered by the study and will not be billed to you or your insurance company.~      The study drug will be dispensed to you free of charge. Meals and lodging at the study site~     will be provided free of charge for the study participant and one care provider.~     Additionally, the research team will assist subjects with booking and obtaining free~     transportation, such as an airline tickets, to and from the study site.~   "
201043|NCT00931151|"~     Dietary protein differing by their amino acid composition could modulate undesirable~     metabolic and functional responses to a meal rich in saturated fat and sugars. This study~     aims at examining the specific effects of dairy protein with different cysteine contents on~     the postprandial undesirables effects elicited by the ingestion of a high fat meal in~     overweight subjects.~   "
201044|NCT00931138|"~     Randomized comparison of standard induction treatment with daunorubicin for 3 days and~     Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of~     maintenance treatment with IL2~   "
201045|NCT00931125|"~     This study investigates the hypothesis that ranibizumab injection given into the eye is a~     safe, efficacious and helping treatment option applied before surgical intervention of the~     proliferative diabetic retinal eye disorder.~   "
201046|NCT00931112|"~     The study is designed to investigate individualized exercise training effects on arterial~     function, walking ability and quality of life in subjects with peripheral arterial disease~     post surgery.~   "
201047|NCT00931099|"~     Sleep disordered breathing (SDB) is a frequent disorder characterized by some combination of~     repeated events of partial or complete upper airway obstruction during sleep, disruption of~     normal ventilation, hypoxemia, and sleep fragmentation. When untreated, SDB is associated~     with serious cardiovascular and neurobehavioral morbidities. Many physiologic changes that~     occur during pregnancy may compromise the respiratory system and place women at risk for~     developing SDB. Indeed, snoring has been reported in up to 46% of pregnant women. Preliminary~     evidence suggests that SDB is associated with the hypertensive conditions of pregnancy and~     that oxidative stress and endothelial dysfunction are mechanisms important in the development~     of both conditions. Moreover, early reports in animals and in humans suggest that maternal~     SDB may affect the developing fetus and that the intermittent hypoxia and increased~     sympathetic activity induced by SDB could potentially contribute to adverse maternal-fetal~     outcome. However, previous reports have focused on crude and non specific measures of fetal~     outcome such as birth weight and APGAR (Appearance, Pulse, Grimace, Activity, Respiration)~     score and currently there is no data on the mechanisms underlying the adverse effect of~     maternal SDB on the fetus and the newborn infant.~      Hypothesis: SDB during pregnancy imposes a risk to the developing fetus and the newborn~     infant through mechanisms mediated by maternal hypoxia.~      Objectives:~        1. To prospectively investigate the incidence and severity of SDB during pregnancy using an~          objective tool, i.e., overnight polysomnography (PSG) or at-home sleep study using~          portable device in a large cohort of pregnant women.~        2. To examine the effect of maternal SDB on fetal and neonatal outcome. Methods: 300 women~          in the third trimester of a singleton uncomplicated pregnancy, who attend a low risk~          obstetric surveillance will be recruited. Hundred women hospitalized at the Antenatal~          department due to pregnancy related hypertensive disorder, intrauterine growth~          restriction (IUGR), diabetes mellitus or premature labor will also be recruited. In~          addition, 200 women of a singleton uncomplicated pregnancy will be recruited during~          labor at the delivery room. All participants will be asked to complete a designated~          sleep questionnaire. Based on the questionnaires, women in the third trimester will~          undergo a sleep study. Medical records review will be conducted after delivery and will~          include information of maternal blood pressure, labor duration, route of delivery,~          infant birth weight and APGAR score. Placentas will be collected immediately after~          delivery from all women. Cord blood will be obtained immediately after delivery and will~          be analyzed. Post-natal neurobehavioral evaluation will be conducted. Data analysis will~          be performed on 4 population subgroups: (1) Sleep study proven SDB, (2) Sleep study~          proven non-SDB, (3) SDB per questionnaire, (4) non-SDB per questionnaire. Comparisons of~          fetal outcome measures according to group assignment will be performed. In addition, the~          association between the severity of SDB based on sleep studies (degree of hypoxemia,~          degree of sleep fragmentation, amount of respiratory events) and outcome measures will~          be performed.~   "
201048|NCT00931086|"~     An expanded access trial of belimumab for named patients who participated in LBRA99.~   "
201049|NCT00931073|"~     This study will evaluate the potential for a drug-drug interaction of Dimebon with~     ketoconazole and omeprazole, potent inhibitors of the drug metabolizing enzymes CYP3A4 and~     CYP2C19, respectively.~   "
201050|NCT00931060|"~     The purpose of this study is to determine whether Branched chain Amino Acids enhances the~     uptake of ammonia in muscle tissue.~   "
201051|NCT00931034|"~     The purpose of this study is to examine the effectiveness of the South Beach Diet and~     products compared to the American Diabetic Association Diabetes Meal Plan.~   "
201052|NCT00931021|"~     This is a pilot research study examining the use of varenicline (Chantix) and the nicotine~     patch. The study is designed to find out whether one of these medications is more effective~     for smoking cessation with head and neck cancer patients. The study has three parts: 1) two~     intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.~   "
201053|NCT00931008|"~     This is a multi-center, randomized, blinded, two-period, two-sequence, crossover study, with~     a minimum 3-week washout period between treatments.The study is designed to evaluate the~     bioequivalence of SID530 to Taxotere.~      It will be conducted in study participants with locally advanced or metastatic NSCLC who have~     failed platinum therapy and also in participants with locally advanced or metastatic breast~     cancer who have failed at least one line of chemotherapy.~      Eligible study participants must be planning to have at least two consecutive 21-day cycles~     with 75 mg/m2 docetaxel monotherapy.~      The duration of study participation will be approximately 7 weeks. The study has three study~     phases: Screening (<=1 week), Cycle 1 (21 days), and Cycle 2 (21 days).~   "
201054|NCT00930995|"~     Hepatitis C is the most common reason for liver transplantation in the United States and~     affects nearly 4 million Americans. Treatments for hepatitis C are available but are poorly~     tolerated and are not always effective. Morbidity and mortality from hepatitis C are related~     to the development and progression of hepatic fibrosis to cirrhosis and end stage liver~     disease. Efforts to block progression of liver disease would thus result in prevention of~     morbidity and mortality as well as costs incurred by the health system in the care of these~     conditions.~      Scar tissue in the liver is secreted by a type of cell, called the stellate cell, in an~     activated state. This cell carries a receptor for angiotensin, a hormone, when activated. If~     this receptor is blocked, the cell becomes inactive and does not participate in scar tissue~     formation. Thus, we hypothesize that using a drug such as candesartan, which blocks~     angiotensin receptors, should result in less scar tissue formation in the livers of patients~     with hepatitis C.~   "
201055|NCT00930982|"~     The purpose of this study is to find out if bacterial load in the airways can be reduced~     after inhalation of ciprofloxacin for 28 days.~   "
201056|NCT00930969|"~     The purpose of ST Detect study is to evaluate whether naturally occurring spontaneous~     coronary events and exercise induced cardiac ischemia, give rise to detectable changes on~     intracardiac electrogram (EGM) signals in patients that are indicated for an Implantable~     Cardioverter Defibrillator (ICD) who have coronary artery disease.~   "
201057|NCT00930956|"~     This study is to determine whether different types of resistant starch have different effects~     on blood glucose in healthy adults.~   "
201058|NCT00930943|"~     The purpose of the study is to determine whether extended-release oxymorphone hydrochloride~     taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts~     cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB)~     tests, to a greater extent than when taking under conditions of fasting.~   "
201059|NCT00930930|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving chemotherapy together~     with everolimus before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed. It is not yet known whether cisplatin and paclitaxel are~     more effective when given together with or without everolimus in treating patients with~     breast cancer.~      PURPOSE: This randomized phase II trial is studying how well cisplatin and paclitaxel work~     when given together with or without everolimus in treating patients with stage II or stage~     III breast cancer.~   "
201060|NCT00930917|"~     It is apparent that the head of a preterm infant should not be left uncovered, however it~     remains unclear whether covering the head of a preterm baby with plastic wrapping is~     effective in preventing heat loss.~      We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate~     if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive~     wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after~     admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap~     prevents postnatal heat loss.~   "
201061|NCT00930904|"~     The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This~     evaluation is based on the number of lead-related complications occurring during the study~     compared to the number of leads enrolled in the study. The leads will be followed for 5 years~     after implant. This study is required by FDA as a condition of approval of the Model 4196 LV~     Lead and is integrated within the Product Surveillance Registry (PAN Registry).~   "
201062|NCT00930891|"~     Despite the fact that a substantial response rate may be obtained in small-cell lung cancers~     (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More~     aggressive regimens remain controversial and recent attempts at increasing dose-intensity~     have been restricted to patients with a more favourable presentation.~      Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial~     Growth Factor). In association with double-drug standard chemotherapies, it has been proven~     that bevacizumab can improve survival of previously untreated advanced non-small-cell lung~     cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on~     NSCLC deserve to be tested on small-cell lung cancers.~      In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to~     experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC~     patients.~   "
201063|NCT00930878|"~     The purpose of this study is to collect real-life data of the Promus™ stent, the Cypher™~     stent and the Endeavor™ stent in routine clinical practice, and compare outcomes.~   "
201064|NCT00930865|"~     To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin~     following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects~   "
201065|NCT00930852|"~     The purpose of this study is to determine whether there is an association between migraine in~     children and certain patterns of appetite or eating behaviour that may lead to later obesity.~   "
201122|NCT00930098|"~     This study is for a population of patients with few or no alternative options that was~     conducted to determine the response rate to clofarabine. Additionally the study will provide~     information on the safety profile, impact of overall survival, and impact on remission~     duration with clofarabine. It is a single arm study and has no comparator.~   "
201066|NCT00930839|"~     This study will focus on investigating the nicotinic acid stimulated release of prostaglandin~     D2 in normal controls. In subsequent studies, the investigators would like to further explore~     this pathway in people with type 2 diabetes. Enhanced blood flow (or flushing) may be~     compromised or exaggerated in type 2 diabetes particularly in those with impairment of~     autonomic function measured as the respiratory heart rate variability (HRV) of different~     frequencies reflecting the balance between the sympathetic and parasympathetic nervous~     systems. The investigators hypothesize that the vasodilatory effects induced by nicotinic~     acid will be different in glabrous and hairy skin and that autonomic imbalance may alter the~     response.~   "
201067|NCT00930826|"~     Childhood Asthma and Schooling: The Truth Unveiled.~   "
201068|NCT00930813|"~     The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for~     treatment of stenosis of the femoropopliteal arteries by direct comparison to standard~     balloon angioplasty.~   "
201069|NCT00930800|"~     The purpose of this study was to investigate the effects of exercise training on exercise~     capacity, physical activity (PA), health-related quality of life (HRQoL), and the~     psychosocial factors affecting PA in sedentary congenital heart defect (CHD) children and~     healthy sedentary children. The degree of improvement after exercise training were compared~     between CHD children and healthy sedentary children.~   "
201070|NCT00930787|"~     Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in~     a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia~     repair is at increased risk of wound related complications, which may be exacerbated by the~     choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia~     recurrence. It is hypothesized that patients receiving a mesh of biologic origin may~     experience fewer wound related complications and hence at least an equal rate of hernia~     recurrence, compared to those receiving a synthetic mesh.~   "
201071|NCT00930774|"~     Many soldiers returning from their recent service in Operation Iraqi Freedom/Operation~     Enduring Freedom (OIF/OEF) were exposed to blasts during combat. About 60% of blast-injured~     soldiers are diagnosed with traumatic brain injury (TBI), with approximately 18% having a~     mild TBI (mTBI). mTBI is associated with many symptoms, including memory problems, headaches,~     difficulty concentrating, increased anxiety, and, especially relevant here, reports of~     difficulty understanding speech in noisy environments and/or when people speak rapidly. While~     problems understanding rapid speech or speech in noise are associated with hearing loss, many~     of the OIF/OEF veterans with these complaints have clinically normal hearing. Although there~     is no physical damage to their ears, these veterans' hearing problems have a negative impact~     on their quality-of-life and functioning. Thus it is incumbent upon the VA to examine~     intervention approaches for veterans with normal/near-normal auditory sensitivity and~     significant complaints of difficulty hearing. Currently, there is no standard-of-care for~     these veterans other than providing information about hearing, hearing conservation, and the~     use of communication strategies. Two forms of rehabilitation likely to be more effective than~     such an informational-counseling approach are: (1) the use of personal miniaturized Frequency~     modulation (FM) systems, and (2) the provision of auditory training with Posit Science Brain~     Fitness Program (BFP). Personal FM systems increase the loudness of the speech signal~     relative to that of the unwanted noise, while the BFP training improves the ability to listen~     by taking advantage of the brain's ability to change (i.e., neural plasticity). In this study~     veterans will randomly be selected to receive one of four treatments: (1) FM use alone, (2)~     BFP training alone, (3) FM+BFP training combined, and (4) informational-counseling. The~     effectiveness of the interventions will be compared using self-report of hearing functioning~     on standard questionnaires. Results will contribute to the development of evidence-based~     intervention approaches for blast-exposed veterans with reported functional hearing~     difficulties and normal/near-normal auditory sensitivity.~   "
201072|NCT00930761|"~     The purpose of this study is to evaluate the impact of music therapy on breastfeeding rates~     among mothers of premature newborns.~      Hypothesis: Music therapy applied to mothers of premature newborns increases the rates of~     maternal breastfeeding at the time of the infant hospital discharge and at follow-up visits.~   "
201073|NCT00930748|"~     The objective of this study is to evaluate imaging quality and correlation with~     histopathology in prostate cancer.~   "
201074|NCT00930735|"~     The presence of scar within heart muscle can act as a substrate for abnormal rhythm problems~     and lead to the developement of heart failure~      Clinical significance Correlation with biomarkers and genetic markers~   "
201075|NCT00930722|"~     This is a prospective, non-interventional, non comparative drug study. The efficacy of~     Quinapril in Asian population has been evaluated, but specifically in Indian patients the~     data is sparse. Data in a real world setting in a large population of Indian patients would~     shed more light on the safety, tolerability and effectiveness of Quinapril in the Indian~     population.~   "
201076|NCT00930709|"~     The purpose of this study is to compare efficacy, feasibility and cost effectiveness of~     botulinum toxin type A injections to active nine weeks strength training and stretching~     program in the treatment of the chronic lateral epicondylitis.~      The main hypothesis is that the botulinum toxin type A injections may enable more rapid pain~     relief while strength training may provide better functional results and less relapses during~     the follow-up.~   "
201077|NCT00930696|"~     Surgical treatment of deep endometriosis with bowel involvement is widely accepted to require~     complete excision of all endometriosis also when invading the bowel. In case of opening of~     the bowel a subsequent inflammatory reaction follows the surgery, as demonstrated by the~     increase in blood levels of C-reactive protein during the first post-operative week.~     Furthermore it increases the risk of post-operative bowel complications. In case of~     peritonitis the general surgeons use extensive lavage in order to decreases mortality,~     morbidity and post-operative adhesions formation, as demonstrated in animal models and~     clinically in patients with peritonitis. Considering the efficacy of extensive lavage for~     peritonitis and the inflammatory reaction as judged by the increased C-reactive protein (CRP)~     following full thickness deep endometriosis resection from the bowel, the study aims to~     evaluate, in women undergoing this procedure, the effect of extensive abdominal lavage on~     abdominal inflammation and post-operative bowel complications.~   "
201078|NCT00930683|"~     To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with~     scleroderma.~   "
201079|NCT00930670|"~     There is conflicting evidence in the literature suggesting that the use of proton pump~     inhibitors (PPIs), and/or some statins can interfere with clopidogrel antiplatelet effect and~     result in adverse cardiovascular outcomes in patients treated with coronary artery stents and~     dual antiplatelet therapy.~      The primary aim of the study is to determine the effect of various currently used PPI on~     platelet aggregation in patients undergoing percutaneous coronary intervention (PCI) and~     treated with dual antiplatelet therapy.~      The secondary aim of the study is to evaluate how statins and 2C19*2 polymorphism modulate~     the effect of PPI on clopidogrel efficacy.~   "
201080|NCT00930657|"~     Objective:~      To examine respiratory/physiological and subjective responding as well as genetic~     transmission among offspring of parents with a history of or current panic disorder (PD)~     diagnosis to determine whether diagnoses/symptoms, endophenotypes, or genetic profiles in~     offspring is differentially related to parent PD subtypes (i.e., respiratory and~     non-respiratory panic).~      Study population:~      Approximately 400 offspring of about 200 parents with current or past PD. Approximately 200~     offsping/100 parents with PD will be enrolled at NIH/NIMH and the remainder at Virginia~     Commonwealth University in Richmond, VA.~      Design:~      A high-risk family design will be used wherein parents with either a current or past~     diagnosis of PD who have an offspring(s) (ages 9 to 20) will be recruited.~      <TAB>~      Outcome measures:~      Outcome measures will include physiological recordings of respiratory, cardiac, and~     electrodermal responding during a 10 minute baseline followed by 15 minutes of 5% carbon~     dioxide enriched air (CO2). Research participants also will complete parent and child~     self-report measures and provide a DNA sample using a saliva protocol. A full listing of~     self-reports is provided in the Outcome Measures Section.~   "
201081|NCT00930644|"~     This study is a 2-year open label extension study to collect long term efficacy and safety~     data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.~   "
201082|NCT00930631|"~     The purpose of this clinical study is to assess the safety, extent and route of [3H]~     BMS747158 radioactivity eliminated (mass balance) in urine and feces of healthy male~     subjects. The safety of [3H] BMS747158 administration will also be assessed, as well as~     pharmacokinetics of [3H] BMS747158 and metabolite identification.~   "
201083|NCT00930618|"~     The purpose of this trial is to determine whether cervical ripening with isosorbide~     mononitrate reduce caesarean section in women with post term pregnancies.~   "
201084|NCT00930605|"~     1. Primary Research Question What are the rates of complete response (CR), partial response~          (PR), progression free survival (PFS) and overall survival (OS) in adult patients newly~          diagnosed with Peripheral T-Cell Lymphoma (PTCL) who are treated with alemtuzumab given~          in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone)~          and ESHAP (etoposide, methylprednisolone, cisplatin, cytosine arabinoside) administered~          as an up-front treatment?~        2. Secondary Research Question What is the incidence of life-threatening toxicities (grade~          3 and 4, according to WHO criteria, Appendix A) in the patients?~   "
201085|NCT00930592|"~     The objective of this study is to assess whether there is an increased risk of the metabolic~     syndrome in children with psoriasis compared to children without psoriasis.~   "
201086|NCT00930579|"~     The purpose of this pilot study is to use a pre surgical intervention model to evaluate the~     biologic effects of metformin in women with newly diagnosed early invasive breast cancer.~     Metformin is a drug commonly used to treat patients with diabetes. This model will be used to~     evaluate the effects of metformin.~   "
201087|NCT00930566|"~     ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson & Johnson] according~     to the following schedule:~      Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the~     first 2 weeks, and 1 ECP per week during 1 month.~      Total = 8 ECP after transplantation.~   "
201088|NCT00930553|"~     This open-label, rater-blinded extension study enrolled participants who had~     relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior~     Genzyme-sponsored studies of alemtuzumab (CAMMS223 [NCT00050778], CAMMS323 [NCT00530348] also~     known as CARE-MS I, or CAMMS324 [NCT00548405] also known as CARE-MS II). The purposes of this~     study were:~        1. To examine the long term safety and efficacy of alemtuzumab treatment in participants~          who received alemtuzumab as their study treatment in one of the prior studies.~        2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for~          participants who received Rebif® (interferon beta-1a) as their study treatment in one of~          the prior studies.~        3. To determine the safety and efficacy of additional as needed alemtuzumab treatment~          courses. This applied both to participants who received alemtuzumab for the first time~          in one of the prior studies or for the first time in this extension study.~   "
201089|NCT00930527|"~     There are no data regarding the use of supplements to alleviate the musculoskeletal pain and~     stiffness inducted by the use of aromatase inhibitors. This study is designated to test the~     safety and efficacy of omega 3 fatty acid supplementation to alleviate musculoskeletal pain~     in postmenopausal breast cancer patients.~   "
201090|NCT00930514|"~     This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and~     intravenous rituximab in participants with follicular lymphoma. In the first stage,~     participants who have achieved at least a partial response after induction treatment with~     intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab~     375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625~     mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of~     the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C~     trough) values comparable to those achieved with the intravenous formulation, participants in~     the second stage of the study will be randomized to receive either the subcutaneous or~     intravenous formulation to demonstrate comparability of the C trough levels with both routes~     of administration. Maintenance therapy will continue every 2 or 3 months with the~     subcutaneous formulation.~   "
201091|NCT00930501|"~     young female cancer patients have improving chances of survival. the main risk is a chronic~     damage to their ovarian reserve. This may lead to future infertility.~   "
201092|NCT00930488|"~     For each patient, an initial visit and at least one follow-up visit at the end of treatment~     should be documented by the treating physician in the case report form.~   "
201093|NCT00930475|"~     This is an open-label, mono-center phase I/II study designed to determine the maximum~     tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with~     carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic~     breast cancer. Additionally, the study is designed to characterize the safety, the~     tolerability and efficacy of this study.~   "
201094|NCT00930462|"~     The aim of this study is to compare the colonoscopy success rate, cecal time and polyp~     detection rate between cap-fitted colonoscopy and conventional colonoscopy.~   "
202273|NCT00914810|"~     The purpose of this study is to determine whether or not vitamin D supplementation can~     improve physical performance in persons with severe chronic obstructive pulmonary disease~     (COPD).~   "
201095|NCT00930449|"~     Our primary aim is to determine whether a computerized working memory (WM) training program~     will help students with severe learning and attention problems, in terms of improving their~     WM. Additional aims are to determine whether the WM training will also result in improvements~     in the students' concentration and school work, and how long any beneficial effects will last~     (i.e., whether the students will continue to show improvements once the training program has~     stopped).~   "
201096|NCT00930436|"~     Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography~     procedure with contrast agent will be asked if they are willing to join the trial. If so they~     will be screened and randomized to receive either sodium bicarbonate or saline before, during~     and after the contrast media is given. They will be asked for serum samples 1 to 3 days, 7,~     30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has~     reduced the incidence of contrast induced chronic kidney disease by measuring their serum~     creatinine, as well as whether they have required renal dialysis or other renal replacement~     therapy.~   "
201097|NCT00930423|"~     Atypical hemolytic uraemic syndrome is caused by defects in the regulating factors in the~     alternative pathway of the complement system. Triggering can cause an uncontrolled complement~     activation with endothelial damage and thrombotic micro-angiopathy, especially in the~     kidneys. This can result in endstage renal failure. Complement activation during hemodialysis~     has been described as a result of contact between blood and the dialysis membrane. Our~     hypothesis is that patients with atypical hemolytic uraemic syndrome have a stronger~     complement activation during hemodialysis than patients with another underlying kidney~     disease. This could be a reason to treat patients with endstage renal failure due to atypical~     hemolytic uraemic syndrome preferentially with peritoneal dialysis instead of hemodialysis.~   "
201098|NCT00930410|"~     The endomicroscopy is an adaptation of traditional optical microscopy in the digestive~     endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a~     videoendoscope, it's possible to study the digestive mucous by optical biopsy. This~     monocentric, non randomized and prospective study uses the Intra-ductal confocal~     endomicroscopy for the characterization of pancreas and bile duct tumor.~   "
201099|NCT00930397|"~     Pre-eclampsia and intra uterine growth restriction (IUGR) represent major complications for~     pregnant women, with a high related maternal and fetal morbidity and mortality. It is now~     widely admitted that these pathologies, which can concern up to 7% of pregnancies, are in~     relation with hypo-perfusion of the placenta because of an early deficient trophoblast~     invasion and uterine vascular remodelling.Advances in ultrasound imaging now permit non~     invasive 3D volume and Doppler signal quantification using automatic~     acquisitions.Quantitative comparison of volumes and Doppler parameters between control~     pregnancies and IUGR ought to confirm the theory of UTERO-placental hypo-perfusion. This~     technique might allow an earlier prediction for IUGR. The aim of this study is to evaluate~     the interest of 3D Doppler quantification as a new screening tool for pre eclampsia and IUGR.~   "
201100|NCT00930384|"~     Main objectives~      1. Establish the association of psoriasis and the presence of NAFLD in the patients with~     psoriasis attending dermatologic clinic center.~      Secondary objective~        1. Evaluate for the presence of other components metabolic syndrome in this group of~          patients including hypercholesterolemia, hypertension, obesity, and insulin resistance~        2. Determine if there is an association between the extent and severity of psoriasis and~          the presence of NAFLD.~        3. Identify an association between BMI and presence of NAFLD in people with psoriasis and~          use it as a predictive index for primary screening of NAFLD in psoriatic patients.~   "
201101|NCT00930371|"~     This study is designed to determine if the amount of fat and saturated fat in the diet~     contributes to the development of a condition called fatty liver disease in the absence of~     changes in weight.~   "
201102|NCT00930358|"~     The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation~     or general anesthesia for colonoscopy~   "
201103|NCT00930345|"~     The aim of this study is to identify and/or validate biomarkers and imaging markers to~     predict and monitor the activity of a new class of therapeutic agents called antiangiogenics~     for the treatment of metastatic renal cell carcinoma (mRCC). Suntinib, approved for this~     indication, will be administred before and after nephrectomy and biomarkers sampling and~     imaging will be operated to monitor the activity and identify prognostic factors in mRCC.~   "
201104|NCT00930332|"~     RATIONALE: Methadone hydrochloride may reduce chronic neuropathic pain in patients with~     cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of methadone~     hydrochloride as first-line therapy in treating patients with chronic neuropathic cancer~     pain.~   "
201105|NCT00930319|"~     Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced~     Hormone-dependent Prostate Carcinoma. The period until Prostate Specific Antigen (PSA)~     progression during the Firmagon® therapy is to be documented and related to the testosterone~     values measured in the course of therapy (if available). Other clinical parameters, the~     patients' quality of life and the direct and indirect costs incurred by the medical care for~     the advanced hormone-dependent prostate carcinoma and its consequences will be evaluated. In~     this context the medical outcome and the life quality are defined as effectiveness and~     benefit value parameters. Both the effectiveness under daily life circumstances and economic~     variables of the therapy can thus be shown and compared within an analysis of costs vs.~     benefits or costs vs. effectiveness.~   "
201106|NCT00930306|"~     The aims of this study are to examine the effect of repeated doses of AZD2066 and of~     caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood~     concentrations of each other~   "
201107|NCT00930293|"~     This study will examine the feasibility and efficacy of a personalized psychotherapy~     treatment for people with depression and co-occurring anxiety.~   "
201108|NCT00930280|"~     The purpose of this study is to find risk factors for hemorrhagic stroke, specifically~     intracerebral hemorrhage (ICH). ICH, a type of bleeding into brain tissue, is a type of~     stroke that can result in death or disability in a large number of people. Our study hopes to~     identify a specific genetic risk factor that will help identify at risk individuals and~     target treatment strategies.~   "
201505|NCT00925067|"~     A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses~     during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on~     postoperative discomfort, chronic pain development, recurrence and male fertility aspects.~   "
201109|NCT00930267|"~     A prospective epidemiological study conducted in pediatric hematology oncology center in~     Hadassah medical center. The study will include all newly diagnosed pediatric cancer patients~     age 0-18 years admitted with fever during chemotherapy.~      In each event of febrile episode during chemotherapy, the following data will be collected~     using a patient data form and computerized software.~      Demographic data: age, gender, ethnicity. Clinical data: Underlying disease, immunizations,~     prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy,~     duration of fever, duration and severity of neutropenia, diagnosis of present event.~      Imaging data Microbiological data Outcome The statistical analysis will be performed by an~     epidemiologist and statistician using the SPSS 12.0 software.~   "
201110|NCT00930254|"~     This research, aimed to verify whether the use of vascular ultrasonography (VUS) could lead~     to better results in the peripheral venous access implementation in children.~      Objectives: To compare, regardless of the number of venous puncture attempts, peripheral~     venous access obtained in children, according to VUS use or traditional method for peripheral~     intravenous catheter (PIC) insertion; assertiveness in the use of PIC in children, defined as~     success in the first attempt of puncture and PIC withdrawal according to release of~     treatment, related to VUS or traditional method and to describe the influence of VUS on PIC~     dwell time and development of local complications related to the use of intravenous therapy~     in children.~   "
201111|NCT00930241|"~     This study is a prospective randomized trial to compare twice daily to once daily~     administration of the basic immunosuppressive regimen in lung transplanted patients.~   "
201112|NCT00930228|"~     The purpose of this study is to determine whether a testosterone receptor blocker (flutamide)~     will normalize sleep-wake luteinizing hormone pulse frequency relationships in women with~     polycystic ovary syndrome.~   "
201113|NCT00930215|"~     The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is~     bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5~   "
201114|NCT00930202|"~     The investigators plan to utilize conivaptan (Vaprisol) to promote isolated water loss, in~     combination with normal (physiologic) fluid replacement to maintain a normal blood volume~     status, in patients with severe TBI. The goal of this therapy is to raise blood sodium in a~     controlled fashion in subjects with severe TBI, and reduce the use of hypertonic saline~     infusion. We hypothesize that this therapy will maintain a stable state of high blood sodium,~     while decreasing the overall sodium load needed to achieve these goals.~   "
201115|NCT00930189|"~     The purpose of this study is to compare the efficacy of photodynamic therapy with verteporfin~     (PDT) and IVTA vs triple therapy (TT) in patients with subfoveal choroidal neovascularization~     (CNV) secondary to age-related macular degeneration (AMD).~      The investigators designed a prospective, comparative, randomized, double blind, controlled~     study. 15 patients with classic subfoveal choroidal neovascularization secondary to~     age-related macular degeneration were randomized. Triple therapy can potentially offer a new~     treatment modality for choroidal neovascularization in patients with macular degeneration and~     other diseases.~   "
201116|NCT00930176|"~     The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single~     dose of 25IU/kg.~      The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the~     treatment of bleeding episodes over at least 6 months.~   "
201117|NCT00930163|"~     This is a randomized, double-blind, placebo-controlled study to evaluate the effects of~     lebrikizumab in patients with asthma who remain inadequately controlled while on chronic~     therapy with inhaled corticosteroids (ICS).~   "
201118|NCT00930150|"~     This study will test whether a cognitive remediation program to treat people with~     schizophrenia can be successfully implemented in a network of research clinics.~   "
201119|NCT00930137|"~     While the deleterious effects of trans fat from industrial sources (iTFA) on cardiovascular~     health are well established, the impact of TFA from ruminants (rTFA) on cardiovascular risk~     factors has not been as well characterized. We have previously shown in men that a very high~     dietary intakes of rTFA (>3.5% of energy) leads to unfavourable changes in lipid~     cardiovascular risk factors that are similar to those seen with iTFA. However, our data also~     indicated that achievable intakes of rTFA that remain well above the current human~     consumption (1.5% of energy intake) had neutral effects on plasma lipids and other~     cardiovascular disease (CVD) risk factors in men. Other studies have also suggested that the~     LDL and HDL response to very high dietary intakes of rTFA (>5% of energy) in women may be~     different than in men.~      The general objective of the study is to investigate for the first time in a double-blind~     randomized controlled study the impact of high but yet achievable intake of ruminant trans~     fatty acids on plasma LDL-Cholesterol and other risk factors for CVD in healthy women.~   "
201120|NCT00930124|"~     Cleft lip and palate patients normally present with a sunken face due to collapse in the~     middle part of the face and inability of the upper and lower teeth to meet during chewing.~     This situation constitutes a serious aesthetic and mastication problem. A single surgical~     operation known as orthognathic surgery was traditionally performed to move the upper jaw~     forward to a more normal position and allow chewing function to be regained. However, due to~     scar tissue from the original surgical repair of the cleft palate, this procedure is known to~     be unstable causing bone to rapidly go back to its original position. A new concept of moving~     the upper jaw bone gradually by 1mm per day using a special device attached to the bone~     called distraction osteogenesis was established in 1996. Animal studies have shown that this~     technique can produce stable results with minimal relapse. The feasibility of correcting~     cleft deformities by gradual distraction has been confirmed by our own clinical studies. The~     aim of this study (which is the first of its kind) is to conduct a prospective randomized~     controlled study and compare the treatment outcomes of the current standard (orthognathic~     surgery) with distraction osteogenesis (gradual bone movement). The objectives focus on four~     aspects: morbidity, stability, speech function and psychological impact. The results from~     this study will clarify several clinical dilemmas in decision making when choosing whether to~     use orthognathic surgery or distraction osteogenesis in the treatment of cleft lip and palate~     patients. In addition, it will also inform our multidisciplinary research team to improve the~     total care of the cleft lip and palate patients.~      Gradual bone distraction of the midface in cleft palate patients is more stable, less~     detrimental to speech, and no more troublesome to the patient than conventional osteotomy and~     bone transposition (orthognathic surgery).~   "
201121|NCT00930111|"~     The investigators are testing the effects of a change in teaching attending physicians'~     rotations (from 4- to 2-week blocks) on patient outcomes (unplanned urgent visits to the~     health care system, inpatient mortality, and length-of-stay), the educational experiences of~     residents and medical students and on the quality of the professional lives of the attending~     physicians.~   "
201506|NCT00925054|"~     The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia~     lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether~     repeated administration is safe.~   "
201123|NCT00930085|"~     The mortality induced by infections in onco-hematological patients is abnormally high at the~     acute phase of septic shock. Consequently, it is important to detect the population with a~     high risk of short term mortality among patients with a septic shock. The aim of this study~     is the evaluation of predictive proteic profile on the short term mortality in the acute~     phase of septic shock in cancer patients.~   "
201124|NCT00930072|"~     To evaluate the feasibility of performing a cervical sympathetic block in patients with~     severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal~     SAH.~   "
201125|NCT00930059|"~     The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on~     cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and~     tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in~     the plasma over the course of the study.~   "
201126|NCT00930046|"~     The investigators propose a prospective blinded randomized control trial (RCT) to assess the~     efficacy and safety of a simple method of continuous infusion of a local anesthetic,~     ropivacaine, via a surgical wound to control pain after ureteropelvic junction (UPJ) stenosis~     correction in children during the first 48 hrs after surgery. The investigators hypothesize~     that this technique will provide greater pain relief post-operatively and reduce the need for~     systemic opioid use along with a reduction in associated side effects of such analgesics.~   "
201127|NCT00930033|"~     The study compare the standard treatment with nephrectomy + sunitinib to treatment with~     sunitinib alone without nephrectomy. This study will be the first trial on this competitive~     context~   "
201128|NCT00930020|"~     Background: Stroke is a leading cause of death and chronic serious disability worldwide.~      Minocycline, a semisynthetic tetracycline, has consistently been shown in recent years to be~     neuroprotective in animal models of brain ischemia. Furthermore, a small, open label study~     done in humans with acute ischemic stroke published late last year showed that minocycline,~     when administered for 5 days, within 6 to 24 hours after stroke onset was highly effective in~     improving functional outcome even as early as 7 days after stroke onset. However, further~     well-conducted, randomized controlled translational studies using minocycline are currently~     lacking.~      Objective: To determine if minocycline, administered within 3 to 48 hours after acute~     ischemic stroke onset is superior to placebo in reducing neurological deficit and improving~     functional outcome at 90 days post stroke.~      Methods: The investigators plan to do a multi-centre randomized, double-blind, placebo~     controlled trial in which ischemic stroke patients will be randomized to treatment with~     either oral minocycline or placebo within 3 to 48 hours of symptom onset. The primary~     efficacy endpoint will be the modified Rankin scale (mRS) score for all randomized subjects~     at 90 days.~      Secondary endpoints will include improvement of the NIH Stroke Scale (NIHSS) score from~     baseline and Barthel index at 90 days.~      NeuMAST will test the following hypotheses:~      Primary Hypothesis: Minocycline, compared with placebo, when administered between 3 to 48~     hours after the onset of acute ischemic stroke improves recovery and functional outcome as~     assessed by mRS scores on day 90 post-stroke.~      Secondary Hypotheses:~        1. Minocycline compared to placebo, when administered between 3 to 48 hours after onset of~          acute ischemic stroke improves recovery and functional outcome as assessed by~          improvement of NIHSS score on day 90 post-stroke.~        2. Minocycline compared to placebo, when administered between 3 to 48 hours after onset of~          acute ischemic stroke improves functional outcome as assessed by the Barthel Index (BI)~          score on day 90 post-stroke.~        3. Minocycline, compared with placebo reduces 90 day risk of recurrent stroke, MI or death~          when administered between 3 to 48 hours after acute ischemic stroke onset.~      A positive result will have a significant impact in the management of acute ischemic stroke~     and pave the way for future studies aimed at finding the optimal dose and formulation of~     minocycline for treating acute ischemic stroke.~   "
201129|NCT00930007|"~     The purpose of this study is to determine whether sleep-wake changes of luteinizing hormone~     pulse frequency are different in early pubertal girls with high testosterone levels compared~     to early pubertal girls with normal testosterone levels.~   "
201130|NCT00929994|"~     It is hypothesized that the addition of formal cardiac rehabilitation to standard care will~     result in long-term improvements in cardiovascular fitness and functional capacity in~     individuals who have suffered a transient ischemic attack (TIA) or minor stroke.~      Furthermore, it is proposed that the addition of cardiac rehabilitation will influence stroke~     risk, physical activity participation, strength, and quality of life.~   "
201131|NCT00929981|"~     This study will be a prospective, non-interventional, single arm and open label study, in~     patients with contact dermatitis requiring systemic steroid therapy with a purpose to obtain~     the real life effectiveness and tolerability of Medrol in treating contact dermatitis in~     Indian patients. Patients with contact dermatitis who have been prescribed for Medrol will be~     enrolled into the study and will be followed up for the resolution of symptoms~   "
201132|NCT00929968|"~     This study will assess the safety and tolerability of multiple doses of VAK694 as well as~     change in symptoms and biomarkers in patients with seasonal allergic rhinitis~   "
201133|NCT00929955|"~     There is some evidence that anti-inflammatory treatment may have beneficial effects in~     schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical~     trials for schizophrenia and depression, showing favourable effects compared to placebo~     (Muller and Schwarz et al 2009).~      Statins were introduced as cholesterol-lowering agents but have found much wider usage. They~     are anti-inflammatory agents and thus similar to the Cox-2 inhibitors, which have shown some~     ability as adjuncts to improve the symptoms of schizophrenia in preliminary studies. The~     statins are also known to decrease C-reactive protein (CRP), which has been shown in an~     SMRI-funded study to be elevated in a study of individuals with schizophrenia. Fan et al~     (2007) demonstrated in a small study in patients with schizophrenia that higher than normal~     levels of CRP (>0.50 mg/dl) was associated with marked negative symptoms and higher total~     PANSS scores.~      Ondansetron is a serotonin (5-HT3) receptor antagonist that is generic and widely used to~     prevent nausea and vomiting in patients receiving chemotherapy for cancer. GSK did a small~     study on it as an antipsychotic in the 1980s. Since then, several small studies have~     suggested that it is effective as an adjunct drug in improving the symptoms of schizophrenia.~      Statins are widely used in schizophrenia sufferers, particularly those taking second~     generation antipsychotics, to treat hypercholesterolemia. Both drugs are well tolerated and~     their side effect profiles well understood.~      We propose to conduct a feasibility study in patients with chronic schizophrenia to explore~     the adjunct use of simvastatin and ondansetron on positive, negative and general~     psychopathology in comparisons to treatment as usual (TAU) over a 12 week period.~   "
201134|NCT00929942|"~     A prospective observational trial involving 10 patients is planned. Intervention SX-ELLA~     Stent Degradable DV Bronchial (DV Stent) will be implanted in the target lesion in general~     anesthesia under fluoroscopy or by direct vision. Before dilatation, extension of the airway~     complications will be measured by bronchoscopy and documented.~   "
201135|NCT00929929|"~     The purpose of this study is to determine whether a nutritional supplement with an amino acid~     called leucine along with resistance exercise are effective in the improvement of muscle~     strength and quality of life in elderly people.~   "
202176|NCT00916084|"~     A new fixed appliance will be used to transfer the tongue force during its physiological~     activity to advance the nasomaxillary complex; this method will be compared with the~     traditional method which uses a facemask with a fixed appliance in the mouth.~   "
201136|NCT00929916|"~     This study will evaluate whether morning-only dosing of MoviPrep® (2L) for afternoon~     colonoscopy is as effective as a standard dosing regimen of half of the volume of MoviPrep®~     (1L) solution the evening prior, and half (1L) the morning of, colonoscopy. MoviPrep® is a~     low volume (2 liters) polyethylene glycol (PEG)-based purgative that is approved for~     evening-only or split (evening and morning) dosing to cleanse the colon prior to colonoscopy.~     Patients undergoing afternoon colonoscopies often have inferior colon cleansing. There is~     evidence that morning-only purgative administration of large volume PEG (4L) is safe and~     effective. This study will assess whether administration of a low volume PEG regimen will~     maintain efficacy and improve tolerance by changing a 2-day preparation procedure into a~     regimen that is completed in 1 day.~   "
201137|NCT00929903|"~     This phase I trial is studying the side effects and best dose of pazopanib hydrochloride in~     treating young patients with solid tumors that have relapsed or not responded to treatment.~     Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~   "
201138|NCT00929890|"~     This study tests the hypothesis that exercise training can confer additional benefit to~     patients in weight-loss programs in the form of improvements in either metabolic or vascular~     parameters or both. Patients will be randomized to either diet plus conventional physical~     activity or diet plus a planned exercise training. The interventions will be carried out~     until the patients lose between 5% and 7.5% of their initial weight. At entry and at the end,~     all subjects will be evaluated for outcomes such as blood glucose, lipid profile, insulin,~     c-reactive protein, fibrinogen, vascular reactivity (doppler ultrasound) and total and~     abdominal visceral fat (CT-scan). Both groups will be compared.~   "
201139|NCT00929877|"~     Primary Objective:~      To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg~     ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120)~     after the first intake of study drug.~      Secondary Objectives:~      To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with~     placebo after the first intake on:~        -  the total pain relief summed over 15 to 360min (TOTPAR15-360)~        -  the changes from baseline of global throat pain intensity assessed over 15 to 120min and~          over 15 to 360min.~        -  the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min~        -  the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To~          compare pain relief, global throat pain intensity, throat soreness and swollen throat in~          the evening of days 1, 2 and 3~      To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at~     follow-up visit on:~      Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed~     by a clinical examination if needed)~   "
201140|NCT00929864|"~     The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no~     worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis~     who are biologic naive~   "
201141|NCT00929851|"~     a 48-week, 2-arm parallel group, fixed combination beclomethasone dipropionate plus~     formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary~     disease~   "
201142|NCT00929838|"~     Blacks or African Americans have greater risk of and are more likely to die from type 2~     diabetes (T2DM). Major barriers to effective diabetes care for Blacks include poor diabetes~     knowledge, self-management skills, empowerment, and perceived control. Few prior studies have~     tested interventions to address these barriers in combination, especially among Blacks who~     have the greatest burden of diabetes related complications. This study provides a unique~     opportunity to address this gap in the literature by testing the efficacy of separate and~     combined telephone-delivered, diabetes knowledge and motivation/behavioral skills training~     intervention in high risk Blacks with poorly controlled T2DM. The findings of this study, if~     successful, will provide new information on how to improve quality of care for diabetes in~     ethnic minorities and reduce the disproportionate burden of diabetes complications and deaths~     in this population.~   "
201143|NCT00929825|"~     The transplantation of hematopoietic stem cells (THSC) is a therapeutic modality developed~     for the treatment of various diseases such as leukemia, bone marrow aplasia, lymphomas,~     multiple myeloma, among others. Most patients who undergo the THSC usually have oral~     manifestations as a result of immunosuppression achieved by chemotherapy and/or radiotherapy.~     The most common complications are the reduction of salivary flow, mucositis and~     graft-versus-host disease (GVHD). These conditions can be very debilitating and interfere~     with medical therapy, leading to systemic complications, affecting the prognosis and~     increasing the length of hospitalization of the patient and the costs of treatment. To date,~     there is no protocol that prevents the reduction of salivary flow and minimizes the~     occurrence of mucositis and GVHD in these patients. This study aims to verify the~     effectiveness of treatment with two sialogogues (Hyperboloid and TENS [transcutaneous~     electrical stimulation]) to restore the flow and biochemical composition of saliva in~     patients undergoing THSC myeloablative and non-myeloablative conditionating regime.~   "
201144|NCT00929812|"~     As a counterregulatory hormone for insulin, glucagon plays a critical role in maintaining~     glucose homeostasis in vivo. It is well known that intramuscular glucagon administration~     stimulates growth hormone (GH), adrenocorticotropic hormone (ACTH) and cortisol release in~     humans. Recently, it has been shown that glucagon induces a remarkable decrease in ghrelin~     levels. The mechanisms underlying this effect are unclear and the role of changes in glucose,~     insulin, glucagon-like peptide-1 (GLP-1) and catecholamines are widely discussed. The aim of~     the present study is to further evaluate the effect of glucagon on ghrelin secretion and the~     possible role of the above mentioned factors in mediating this effect.~   "
201170|NCT00929461|"~     Pre- and intra-operative nutritional support in patient undergoing major surgery results in~     decreased morbidity and mortality. Studies investigating the role of omega-3 fatty acids in~     these patients are increasing. Some are focused on perfusion at the cellular level. This~     study was undertaken to address the effect of postoperative administration of omega-3 fatty~     acids on cellular hypoperfusion associated with major gastric surgery.~   "
201248|NCT00928434|"~     The purpose of this study was to see if giving Degarelix every month for 7 months then stop~     treatment for 7 months (intermittent therapy) would show a reduction of negative effects of~     androgen deprivation therapy by increasing the quality of life while keeping prostate~     specific antigen (PSA) levels suppressed.~   "
201145|NCT00929799|"~     The aim of the study is to investigate changes in insulin sensitivity and ß-cell function~     after 24 and 48 weeks of low-dose growth hormone (GH) therapy in adult patients with severe~     GH deficiency using highly standardized techniques. Insulin sensitivity was estimated using~     euglycemic, hyperinsulinemic clamps, while insulin secretion and hepatic insulin clearance~     were determined by changes in insulin and C-peptide levels during hyperglycemic~     hyperinsulinemic clamps with consecutive intravenous (i.v.) L-arginine stimulation tests.~     Moreover, the researchers investigated changes in body composition, lipolysis and~     cardiovascular risk markers. Furthermore, in order to verify the mechanisms involved in the~     pathogenesis of GH-induced insulin resistance and the GH-induced improvement in insulin~     resistance under long term treatment, the researchers intend to establish changes in~     intramyocellular lipid (IMCL) in patients with GH deficiency by magnetic resonance~     (MR)-spectroscopy before and during GH-treatment and to correlate IMCL with insulin~     resistance, insulin secretion and insulin clearance. Finally, the researchers aim to justify~     the effect of GH on adiponectin secretion as well as on the 11-ß hydroxylase activity.~   "
201146|NCT00929786|"~     The purpose of this study is to evaluate plasma levels of hepatotoxic anti-tuberculous drugs~     (isoniazid, rifampicin, pyrazinamide plus significant metabolites) among patients on~     antituberculosis treatment (ATT) and compare the same among those who develop drug induced~     hepatitis on follow up versus those who do not.~   "
201147|NCT00929773|"~     The purpose of this study was to determine whether low level laser light directed at the neck~     and shoulders could be effective in the temporary reduction of chronic pain in the neck and~     shoulder region.~   "
201148|NCT00929760|"~     This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney~     disease (CKD) in order to determine the impact of specialised care by nephrologists compared~     to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical~     outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation~     RRT) and c) patient satisfaction.~   "
201149|NCT00929747|"~     A prospective evaluation of postoperative corneal aberrations and visual parameters in~     patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group~     implanted with a SN60WF IOL and having concomitant limbal relaxing incision.~   "
201150|NCT00929734|"~     The purpose of this study is to investigate whether rosuvastatin improves measures of~     endothelial function, decreases measures of inflammation, and improves pulmonary function in~     patients with stable chronic obstructive pulmonary disease.~   "
201151|NCT00929721|"~     This study is an observational surveillance study to identify adults 50 years and older who~     present to a study healthcare facility with signs and symptoms of Community-Acquired~     Pneumonia.~   "
201152|NCT00929708|"~     The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks~     treatment with AZD3199 in moderate to severe COPD.~   "
201153|NCT00929695|"~     This randomized phase III trial is studying low-dose prednisone or methylprednisolone to see~     how well they work compared with standard-dose prednisone or methylprednisolone in treating~     patients with newly diagnosed acute graft-versus-host disease (GVHD). Glucocorticoids, such~     as prednisone or methylprednisolone at a starting dose of 2 mg/kg/day are standard treatment~     for acute graft-versus-host disease caused by a donor stem cell transplant. It is not yet~     known whether low-dose glucocorticoids are more effective than standard-dose glucocorticoids~     in treating acute graft-versus-host-disease~   "
201154|NCT00929682|"~     In a prospective randomised study involving primiparous women in spontaneous uncomplicated~     labour with cervical dilatation > 7 cm, epidural analgesia will be given with an initial~     volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual~     injections to achieve analgesia, then by a patient-controlled regimen with 5-mL~     self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic~     solution will be levobupivacaine presented in 100-mL bags from the market, 0.0625%, or~     0.125%, in which 10 mL (50 µg) of sufentanil will be added. The final concentrations will be~     0.568 and 1.136 mg.mL-1 respectively, both with sufentanil 0.45 µg.mL-1. Parturients and~     midwifes assessing pain during labour will be blinded to the design~   "
201155|NCT00929669|"~     The purpose of this study is to determine if administration of pasireotide LAR for one year~     to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce~     the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.~   "
201156|NCT00929656|"~     Stroke is the leading cause of long-term disability in this country with more than 1 million~     Americans reporting difficulty with daily activities. Loss of independence in self-care tasks~     is primarily due to limited recovery of the arm. This study will determine if the addition of~     Transcranial Magnetic Stimulation (TMS) to excite the lesioned hemisphere (side of the brain~     affected by the stroke), to progressive functional task exercise either of the weakened arm~     alone or of both arms together will improve arm recovery to a greater degree than one of~     these two types of arm exercise alone. Individuals post-stroke will participate in 16~     sessions of 1) arm rehabilitation alone (with the weaker arm only or with both arms together)~     or 2) arm rehabilitation plus TMS. The investigators will assess arm movement ability and~     function immediately following the 4-week intervention and at a 30-day follow-up to determine~     retention of immediate gains. The investigators hypothesize that those who receive TMS as an~     adjuvant will have improved arm movement ability than those who only exercise.~   "
201157|NCT00929643|"~     The objective of this study is to estimate the costs of empiric antibiotic therapy and~     hospitalization costs for patients with a complicated intra-abdominal infection, and to~     assess the impact of treatment failure of initial antibiotic empiric therapy on~     pharmacological and total healthcare costs for these patients in Greece.~   "
201187|NCT00929240|"~     This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda~     (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer~     who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients~     will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each~     cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not~     progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of~     each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone.~     Study treatment will continue until disease progression, unacceptable toxicity, patient~     request for withdrawal or end of study, and the target sample size is 100-500 individuals.~   "
201158|NCT00929630|"~     Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving~     techniques like loose or cutting seton and fistulectomy with advancement of an endorectal~     flap have been advocated to minimize the risk of sphincter injury, but patients often~     complain of a prolonged healing period and major discomfort. Furthermore, the healing rate~     varies widely according to the type of fistula and the surgeon's experience.In the early '90s~     the treatment of perianal fistulas by autologous or commercial fibrin glue was suggested and~     the American FDA approved the use and marketing of a human fibrin glue in 1998.~      Since then, several studies have evaluated the effectiveness of human fibrin glue in the~     treatment of different types of perianal fistulas, reporting a wide range of success rates~     ranging from 31 to 85%.~      Primary aim of this study is to conduct a prospective randomized trial evaluating the~     effectiveness of glue treatment of perianal fistulas as compared with the classical seton~     treatment. Secondary aims are to compare postoperative faecal incontinence, postoperative~     anal pain, healing time and length of hospitalization.~   "
201159|NCT00929617|"~     The purpose of the study is to compare the effects of one exercise/counseling protocol with~     usual care on long term exercise adherence and on changes in health related outcomes after~     breast cancer diagnosis.~   "
201160|NCT00929604|"~     No randomized clinical trial to date has demonstrated a survival benefit of using regular~     HIV-1 ribonucleic acid (RNA) viral load (VL) testing to monitor patients' responses to~     antiretroviral therapy (ART) for HIV infection. The measurement of VL is recommended to~     monitor the response to ART in developed countries. In resource-constrained settings, the~     World Health Organization (WHO) does not recommend routine VL testing, in part due to the~     cost and complex infrastructure needed for reliable results. In these settings, WHO has~     proposed the use of clinical and CD4+ lymphocyte-based criteria to guide treatment decisions.~     However, multiple studies have demonstrated the poor performance of these criteria in~     sub-Saharan Africa and the frequent discordance between immunologic and virologic responses~     to ART.~      The use of routine viral load monitoring should be evaluated in resource-constrained~     settings. The investigators hypothesize that routine viral load testing of patients on ART~     will improve patient survival, decrease disease progression and development of drug~     resistance, and will be feasible and cost-effective for resource-constrained settings.~   "
201161|NCT00929591|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Drugs~     used in chemotherapy, such as doxorubicin, cyclophosphamide, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. It is not yet known whether giving tamoxifen alone is more effective in~     treating breast cancer than giving tamoxifen together with chemotherapy or after~     chemotherapy.~      PURPOSE: This randomized phase III trial is studying giving tamoxifen with or without~     combination chemotherapy to compare how well they work in treating postmenopausal women who~     have undergone surgery for breast cancer.~   "
201162|NCT00929578|"~     The objective of this study is to assess the safety and biologic activity of intralesional~     injection of fluphenazine in adult subjects with psoriasis.~   "
201163|NCT00929565|"~     Some of the risk factors for bleeding following bronchoscopy is having a malignancy or an~     immunocompromised state. The etiology of this remains uncertain. The investigators suspect~     that individuals with malignancy have abnormalities involving certain factors that influence~     the coagulation pathway.~      The investigators plan to measure these factors prior to and after bronchoscopy.~   "
201164|NCT00929552|"~     The aim of the study is to investigate if dietary fish oil has a beneficial effect on blood~     pressure, insulin sensitivity, blood lipid profile, body composition and metabolic rate in~     healthy, but slightly overweight, teenage boys.~      We hypothesized that the n-3 long chain polyunsaturated fatty acids from fish oil might have~     greater effect during growth and development, as intervention trials studying the effect of~     fish oil on babies have shown greater effects than in adults.~   "
201165|NCT00929539|"~     The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the~     safety and tolerability of JTT-130 in obese Type 2 diabetic patients.~   "
201166|NCT00929526|"~     This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against~     cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological~     abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic~     HPV types for an additional two years. All subjects who participated in the primary~     vaccination study NCT00316693 and who confirmed their interest in participating in a long~     term follow up study will therefore be invited to be followed for up to 48 months after~     administration of the first dose of vaccine. In addition, safety and persistence of the~     humoral immune response will be evaluated in this study.~      This protocol posting deals with objectives & outcome measures of the extension phase at~     Months 36 and 48. The objectives & outcome measures of the primary phase are presented in a~     separate protocol posting (NCT number = NCT00316693).~   "
201167|NCT00929500|"~     The purpose of this study is to test whether a supervised mixed aerobic and strength training~     (MAST) program is effective in improving overall physical fitness and blood flow in the brain~     and lowering risk factors of coronary artery disease (CAD) in women with metabolic syndrome.~   "
201168|NCT00929487|"~     The purpose of this study was to clinically evaluate lens care solutions used with soft~     contact lenses.~   "
201169|NCT00929474|"~     Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in~     patients with left ventricular systolic dysfunction and congestive heart failure.~     Additionally in CRT patients it has been demonstrated that optimizing paced/sensed~     atrioventricular (AV) and interventricular (V-V) timings leads to immediate hemodynamic~     benefits and further improves cardiac function. Recent studies have shown that optimal~     paced/sensed AV and V-V delays change over time, which raises the question of how often~     optimization should be repeated. Thus, frequent re-optimization of these delays might be~     beneficial for maintaining significant improvement of cardiac function. However, it remains~     to be evaluated whether timing optimization may be beneficial on patients who have received~     CRT for a number of years and are now having the CRT device replaced.~   "
201249|NCT00928421|"~     To determine the effect and safety of Varisolve® 0.125% [0.2%]~   "
202215|NCT00915577|"~     Determine patient satisfaction with the single-use autoinjector for the delivery of~     pre-filled Avonex syringe.~   "
201171|NCT00929448|"~     The development of pneumonia and other infections is one of the most common complications of~     a traumatic brain injury (TBI). Prior studies have also found that patients suffering from~     TBI also develop immune dysfunction consistent with an immunosuppressed state shortly after~     the traumatic event. Specifically, it has been shown that patients with a TBI have impaired~     delayed type hypersensitivity (DTH), cellular immunity and humoral immunity. The humoral arm~     of the immune system is particularly involved in defending the host against extracellular~     bacteria and is primarily composed of B-cells, immunoglobulins and complement. Surgery and~     trauma impair the clonal expansion of antibody producing B lymphocytes causing~     hypogammaglobulinemia, through a mechanism involving T lymphocytes. In addition, during the~     systemic inflammatory process, pro-inflammatory cytokines such as tumor necrosis factor alpha~     (TNF-alpha), interleukin 1 (IL-1beta) and interleukin 6 (IL-6) are released. Nuclear factor~     kappa beta (NF-kB) is a transcriptional regulatory protein that is involved in the expression~     of proinflammatory cytokines and appears to act at a critical step in the transcription of~     many proinflammatory genes.~      The hypothesis of this study is that the hypogammaglobulinemia from the immune dysfunction~     and the induction of NF-kB from the inflammatory process are, in part, responsible for the~     development of pneumonia and other infectious complications identified after TBI. This study~     has two specific aims: The primary specific aim of this study is to determine the association~     between serum immunoglobulin or NF-kB levels and the development of pneumonia in patients~     suffering from traumatic brain injury (TBI). The secondary specific aim of this study is to~     determine the relative contribution of clinical variables such as APACHE II-III Score and~     Injury Severity Score as compared to immunological variables (serum immunoglobulins and~     NF-kB) to the development of pneumonia in patients suffering from TBI.~   "
201172|NCT00929435|"~     One hundred new residents will be recruited prior to the start of residency and followed~     prospectively for a year. Monthly nasal swabs will be performed to identify colonization with~     methicillin resistant staphylococcus aureus (MRSA).The proportion of study subjects colonized~     with MRSA at the end of 1 year will be calculated.~   "
201173|NCT00929422|"~     Background: Spinal cord injury (SCI) results in dysfunction of motor and sensory system and~     the hormonal secretion. Not only the change of peripheral hormonal organs, the central~     neurotransmitters were also affected. We consider there are some changes in cerebral~     physiology, anatomy or function after SCI.~      Objective: Use PET imaging to investigate the brain functional difference among the SCI and~     control group.~   "
201174|NCT00929409|"~     200 patients with post partum anemia will be randomised to receive either intravenous iron~     (intervention group) or peroral iron (control group).~      The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.~   "
201175|NCT00929396|"~     The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit~     vaccine administered at 0 and 2 months.~   "
201176|NCT00929383|"~     The IRISS study is designed to collect clinical and angiographic outcomes data when stenting~     intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA~     Balloon Catheter in routine clinical practice.~   "
201177|NCT00929370|"~     The purpose of this study is to understand safety and tolerability of the drug GSK1018921~     after 14 days of dosing in healthy volunteers and then in patient volunteers.~   "
201178|NCT00929357|"~     This study involves review and analysis of disease activity in patients with rheumatoid~     arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic~     Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and~     feet taken as part of routine treatment monitoring within a time interval of 12 to 36 months.~   "
201179|NCT00929344|"~     A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150~     outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d,~     duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and~     follow-up visits 1 week and 3 months post-treatment.~   "
201180|NCT00929331|"~     This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010~     Season) in adults aged 18 to 60 years and over 60 years.~   "
201181|NCT00929318|"~     Main goal of this clinical investigation is to investigate different cytokines in wound~     fluids of euthyroid vs. hypothyroid patients. As a primary endpoint we want to evaluate if~     different cytokine levels in euthyroid vs. hypothyroid patients exist and to what extent~     these cytokines differ. Our targeted cytokines are: IL6, IL10, TNFa and MCP-1. From the~     literature these 4 factors seem to be the most reasonable to measure and to focus on.~     Additionally we focus on these 4 factors for financial reasons, technically there wouldn't be~     a problem to measure more, which is correlated with higher costs. Besides, more than 6~     factors would mean larger amounts of sample fluids needed, which would cause technical~     problems. These factors don`t have to change in the same direction. Secondarily, we believe~     that differences in cytokine profiles of hypothyroidism vs. euthyroidism will correlate to~     differences in duration and clinical characteristics of the wound healing process.~   "
201182|NCT00929305|"~     The purpose of this study was to determine whether the application of low level laser light~     therapy to the neck and shoulder region is effective in reducing chronic neck and shoulder~     pain of musculoskeletal origin.~   "
201183|NCT00929292|"~     The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance~     and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant~     formula.~   "
201184|NCT00929279|"~     In full responders to clopidogrel scheduled to undergo PCI for NSTEACS, the use of abciximab~     bolus only plus 600 mg clopidogrel loading dose will result in a non-inferior inhibition of~     platelet aggregation after 4 hours as measured by LTA (20micromol ADP) when compared with~     abciximab plus infusion and 300 mg clopidogrel loading dose.~   "
201185|NCT00929266|"~     To study the in vivo life span in healthy volunteers of red blood cells generated in vitro~     from autologous peripheral stem cells. The study will be carried out in 4 phases :~        -  production in vitro of the equivalent of 1 ml of blood, i.e. 5x10e9 enucleated RBC from~          mononuclear cells isolated from an HSC graft obtained from a healthy volunteers donor.~        -  labeling of these cRBC with 51 Cr~        -  reinjection of the autologous cRBC~        -  follow up of the receivers for a maximum 33 days to measure the half-life span of the~          injected cells.~   "
201186|NCT00929253|"~     This study is designed to examine the effects of combined buprenorphine and voucher~     incentives to promote abstinence from illicit opiate use, along with or without~     computer-delivered therapy, during treatment of opioid dependence.~   "
201214|NCT00928876|"~     Obesity is characterized by continuous low-grade inflammation. This is an important link~     between obesity and insulin resistance.~      Results from the investigators' own group of in vitro and in vivo research on mice show that~     Interleukin-1 is involved in the process of developing insulin resistance. Earlier it has~     been shown that interleukin-1 receptor antagonist in human subjects improves glycemic~     control. The investigators' hypothesis is that this is due to improved insulin sensitivity.~   "
201188|NCT00929227|"~     Background:~        -  Noninvasive cardiac stress testing is imperfect. Inconclusive test results generate~          further expensive testing.~        -  In patients with known or suspected coronary artery disease, both computed tomography~          (CT) and magnetic resonance imaging (MRI) have been shown to provide suitable results~          for detecting the disease. However, both types of scans have limitations in their~          usefulness, and it is not known whether one is preferable in either accuracy or~          cost-effectiveness.~      Objectives:~      - To determine the accuracy and cost-effectiveness of CT and MRI in subjects with a prior~     inconclusive heart stress test.~      Eligibility:~      - Patients 18 years of age and older who have had an inconclusive heart stress test within~     the past 90 days.~      Design:~        -  A blood test will be obtained prior to both heart tests. This will require less than a~          teaspoon of blood.~        -  A CT scan will be performed, accompanied by beta blocker medications (to slow heart~          rate) or nitroglycerin (to enlarge blood vessels) to improve picture quality, as needed.~        -  An MRI scan will be performed. Scans will be taken before, during, and after the patient~          receives vasodilators (to increase blood flow to the coronary arteries and detect~          blockages in heart blood vessels).~        -  Heart rate and function will be monitored with an electrocardiogram.~   "
201189|NCT00929214|"~     The goal of this clinical research study is to find out if adding local therapy (surgery~     and/or radiation) to standard therapy (chemotherapy or endocrine therapy) in the treatment of~     patients with metastatic breast cancer can help to control the disease for a longer period of~     time than standard therapy alone.~   "
201190|NCT00929201|"~     This study will demonstrate the bioequivalence of metformin after single dose administration~     of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant~     administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual~     tablets after consumption of a high-fat meal.~   "
201191|NCT00929188|"~     The purpose of this study is to compare the safety and effectiveness of JNJ-42160443 with~     placebo in the treatment of chronic, moderate to severe cancer-related pain in terminally ill~     patients with a diagnosis of active cancer.~   "
201192|NCT00929175|"~     Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the~     effect of treatment of OSAS on the resistant hypertension have no been established. In a~     double-blind randomized clinical trial patients with resistant hypertension with at least~     moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight~     weeks in an ambulatory set. The investigators want to determine any difference on~     hypertension control between the 2 management strategies.~   "
201193|NCT00929162|"~     The purpose of this study is to compare progression-free survival in patients with advanced~     ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo~     in combination with carboplatin+paclitaxel.~   "
201194|NCT00929136|"~     The aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and~     protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin~     will induce insulin resistance, lypolysis and proteolysis acutely.~   "
201195|NCT00929123|"~     The purpose of this study was to determine the effect of a manual therapy technique (neural~     mobilization) on measures of clinical pain and function, experimental pain sensitivity, and~     on the function of the median nerve in individuals with carpal tunnel syndrome. The~     investigators hypothesized that individuals receiving a neural mobilization technique known~     to directly stress the median nerve would demonstrate greater improvements in clinical pain~     and function, experimental pain sensitivity, and median nerve function than those receiving a~     sham technique.~   "
201196|NCT00929110|"~     This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily~     (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic~     obstructive pulmonary disease.~   "
201197|NCT00929097|"~     The aim of this study is to improve clinicians' calculation, interpretation and communication~     of familial colorectal cancer risk, as well as patients' risk perception and uptake of~     referral for genetic counselling or for surveillance by colonoscopy for their relatives at~     risk.~   "
201198|NCT00929084|"~     The purpose of this study is to evaluate in a randomized controlled trail, an innovative~     cancer communication strategy to help African American breast cancer patients cope with a~     variety of challenges during and after treatment and to better adhere to recommended~     treatment guidelines and follow-up care.~   "
201199|NCT00929071|"~     The study doctor will give EVOLENCE® mixed with Lidocaine to people in this study to see if~     it effectively reduces pain while injecting and works to correct nasolabial wrinkles.~      The product being used in this study is EVOLENCE®, which is currently marketed in the United~     States for the cosmetic correction of soft tissue contour deficiencies (including wrinkles),~     and been approved by the U.S. Food and Drug Administration (FDA).~   "
201200|NCT00929058|"~     Rationale: The introduction of angiogenesis inhibitors has remarkably improved treatment of~     patients with several types of cancer. One of the most common side effects of angiogenesis~     inhibitors is hypertension. In patients treated with bevacizumab hypertension had an overall~     incidence up to 32%. The etiology of hypertension caused by treatment with angiogenesis~     inhibitors is unclear.~      Objective: To study if arterial bevacizumab infusion causes acute vasoconstriction using~     plethysmography in healthy volunteers.~   "
201201|NCT00929045|"~     The purpose of this study is to look at the relationship between growth hormones, and~     recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with~     the body's ability to produce growth hormones. These hormones may be needed by the body for~     growth, mental development and sexual maturation.~   "
201215|NCT00928863|"~     The objectives of this study is first to asses to what extent the guidelines of the Dutch~     Society of Obstetrics and Gynaecology (NVOG) and the MOET (Management of Obstetric and~     Emergencies and Trauma) instructions for haemorrhagia postpartum have been implemented in~     current care in the Dutch practice. Second to study barriers and facilitators for guideline~     adherence and to develop and test a tailored implementation strategy, based on these~     findings.~   "
201250|NCT00928408|"~     This is a multicentre, descriptive observational study of adult patients with primary HPT~     receiving cinacalcet in clinical practice in a number of countries in Europe. Patients will~     be enrolled within 1 month of initiating cinacalcet treatment, and data will be collected~     prospectively for up to 1 year from initiation. Data will continue to be collected from~     patients discontinuing cinacalcet before the end of this period.~   "
201202|NCT00929032|"~     Study summary: Liver transplantation and the reticuloendothelial clearance capacity.~      The purpose of this study is to evaluate the effect of liver transplantation on the immune~     system.~      This study will involve the taking of a number of observations but does not involve any~     treatment, which differs from normal care. Indications for transplantation are solely based~     on the best clinical practice, which is usually performed at the department.~      The study measures liver function based on the clearance of different marker substances by~     the liver. These substances are given intravenously and their clearance will be measured from~     bloodstream.~      All substances used in this study are registered in the United Kingdom for clinical~     applications and already used in clinical practice over years. They are safe and without any~     risk to harm individuals under study. Furthermore no side effects or any symptoms caused by~     the administration of these substances are expected.~      Measurements of liver function are undertaken before transplantation, 1 and 7 days following~     the transplant. There is no restriction from any of the patient's prescribed medication. All~     blood samples will be removed from the cannula (drip) and will not require repeated~     injections. It is hoped that this research will lead to a greater understanding of the~     effects of liver transplantation on the immune system.~   "
201203|NCT00929019|"~     1. Rationale~           Immunotherapy applying ex vivo generated and tumor antigen-loaded dendritic cells (DC)~          has now successfully been introduced in the clinic. A limited, but consistent, number of~          objective immunological and clinical responses have been observed. Most of the~          successful results have been observed in patients with minimal residual disease, rather~          than patients with advanced metastatic disease. Moreover, the investigators' preliminary~          results show that presence of tumor epitope specific T cells in biopsies taken from~          delayed type hypersensitivity (DTH) reaction sites highly correlates with prolonged~          progression free survival (PFS).~           Within uveal melanoma patients, a group with high risk of metastatic disease can be~          identified on basis of tumor specific genetic changes in loss of chromosome 3.~           At present no standard adjuvant or systemic treatment is available. Applying DC-based~          immunotherapy in this group of high risk patients might reduce the risk of recurrence~          without interference in the current treatment guidelines.~        2. Objectives~           In this joint clinical study of Radboud University Nijmegen Medical Centre (RUNMC) and~          Rotterdam Eye Hospital, the investigators aim to determine the in vivo immunological~          response induced in high risk uveal melanoma patients vaccinated with mRNA-transfected~          DC.~        3. Study design~           This study is an open label non-randomized phase II intervention study.~        4. Study population~           The investigators' study population consists of HLA-A2 positive patients with a high~          risk uveal melanoma with proven expression of melanoma associated antigens tyrosinase~          and/or gp100.~        5. Main study endpoints~      This is an exploratory study aiming to demonstrate proof of principle. The first study~     endpoints are in vivo immunological response induced in high risk uveal melanoma patients~     vaccinated with mRNA-transfected DC, administered i.v./i.d. and toxicity. Secondary study~     endpoints are progression free survival, overall survival, and toxicity.~   "
201204|NCT00929006|"~     The purpose of this study is to determine if in late pubertal girls without hyperandrogenemia~     (HA), progesterone (P) will acutely reduce waking lutenizing hormone (LH) frequency to a~     greater extent than sleep-associated LH frequency. We hypothesize that in late pubertal girls~     with HA: (a) waking and sleep-associated LH frequency will be elevated (compared to~     controls); and (b) P will suppress waking LH frequency to a lesser degree than it does in~     girls without HA.~   "
201205|NCT00928993|"~     The purpose of this study is to learn how well an instrument called an Actiwatch-2 can~     determine whether a child is asleep or awake. The Actiwatch-2 (manufactured by~     Minimitter/Respironics of Bend, Oregon) is the brand name for an actigraphy monitor; that is,~     a motion sensor that is typically worn on the wrist and looks like a wrist watch. It measures~     and records the amount of movement a person makes each minute. After being worn overnight,~     data are transferred from the Actiwatch to a computer, and a program estimates whether a~     person is awake or asleep by analyzing the recorded movement data. The enrollment target is~     80 participants. Although other actigraphy equipment has been used to monitor sleep in~     children, the Actiwatch-2 has not been validated in the pediatric population.~   "
201206|NCT00928980|"~     The purpose of this study is to investigate the (cost)effectiveness of mindfulness based~     cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination~     with regard to the prevention of relapse or recurrence in patients with recurrent depression.~   "
201207|NCT00928967|"~     To evaluate the evolution of the impact on daily life activities over the first 12 months~     following the introduction of interferon beta-1b treatment in patients presenting RRMS or~     patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating~     event~   "
201208|NCT00928954|"~     Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients,~     who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV.~     Two medicines have been reported to suppress nystagmus and improve vision in such patients:~     gabapentin and memantine. The investigators set out to test which of these two drug was more~     effective by carrying out a double-blind cross-over study. In this way, we could determine~     which drug worked best in each patient.~   "
201209|NCT00928941|"~     Post Traumatic Stress Disorder (PTSD) is an emotional disorder that can also lead to problems~     with attention and memory. Cognitive training has been successfully used to improve attention~     and processing speed in other patient populations as well as healthy elderly. The purpose of~     this study is to examine how effective cognitive training will be in Veterans with PTSD.~   "
201210|NCT00928928|"~     Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for~     colorectal cancer~   "
201211|NCT00928915|"~     Intracerebral haemorrhage (ICH) is the most feared complication in patients on vitamin K~     antagonists (VKA). VKA related ICH occurs 8-10 times more frequently and the mortality is 2~     times higher than in non-anticoagulated patients. Mortality may rise up to 67%. The higher~     mortality rate may in part be due to the higher rate of haematoma expansion (HE) over a~     longer period after symptom onset. International guidelines recommend treatment of VKA-ICH~     with prothrombin complex (PCC) or fresh-frozen plasma (FFP) both in combination with~     Vitamin-K. But these recommendations are not based on randomized controlled trials. It is~     known that these drugs lower the INR, and thus it is assumed that normalization of~     coagulopathy may lead to haemostasis and reduction of HE. Safety and efficacy of these~     treatments have never been studied in a prospective controlled trial.~      The investigators' questions are: How potent are PCC and FFP in normalization of the INR?~     What is the safety profile of each of these drugs?~   "
201212|NCT00928902|"~     This clinical pilot study will test the hypothesis that systemic low-dose IL-2 therapy~     significantly enhances the immunologic efficacy of a vaccine comprising melanoma peptides~     plus GM-CSF-in-adjuvant.~   "
201213|NCT00928889|"~     This study was conducted to demonstrate superiority of nateglinide in postprandial glucose~     fluctuation, dyslipidemia, and inflammatory status improvement.~   "
201216|NCT00928850|"~     This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are~     able to randomize patients to test modifications of surgery to remove the prostate. Surgery~     to remove the prostate is known as a radical prostatectomy. Surgeons know many things about~     the best way to do a radical prostatectomy. However, there is disagreement about some aspects~     of surgery. Two modifications of surgery to remove the prostate (radical prostatectomy)~     identified for this study include Irrigation, and Fascial Suturing.~      Two aspects of the operation may vary, fascial suturing and urethral irrigation. For each~     aspect, surgeons will use their clinical judgment as to the best interests of the patient. In~     other words, if there are clear reasons to use or avoid a fascial suturing approach, the~     surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid~     irrigating the urethra, the surgeon can make the appropriate clinical decision. If the~     surgeon is unsure as to which approach to take, then the randomization scheme will be~     followed.~      All of the surgeons who are taking part in this study have used these techniques at different~     times. However, they are unsure as to the best approach. Sometimes, they use different~     treatments with different patients.~      Irrigation. Cancer cells can spill during surgery and this can cause cancer to return~     (recur). Some surgeons believe that irrigating could help stop spilling of cancer cells.~     Irrigating means washing the surgical area with sterile water and sucking the water back up~     through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will~     examine irrigation of the urethra. This is the part of the body that carries urine from the~     bladder to the penis.~      Fascial suturing. Surgeons believe that what happens to the urethra can affect the risk of~     incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea~     is that additional stitches (sutures) to the connective tissue (fascia) could be helpful,~     but this is not known for sure.~   "
201217|NCT00928837|"~     The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with~     Naproxen and placebo in OA of the knee.~   "
201218|NCT00928824|"~     The purpose of this study is to determine whether traditional japanese diet blood pressure in~     healthy volunteers.~   "
201219|NCT00928811|"~     The study is undertaken to explore the safety of using Simulect at monthly dose intervals to~     reduce the need of high dose/level CNI's such as Prograf.~   "
201220|NCT00928798|"~     The purpose of the study is to determine whether topical application of rapamycin can lead to~     reduction in size and/or number of fibrofolliculomas in BHD patients and may prevent the~     growth of new ones. Secondary we evaluate rapamycin safety, formula acceptance and patient~     satisfaction.~   "
201221|NCT00928785|"~     The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®)~     will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid~     vaccine alone in healthy adults.~   "
201222|NCT00928772|"~     Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without~     excessive drowsiness in preoperative settings.~   "
201223|NCT00928759|"~     The purpose of this study is to learn if obese pre- and early pubertal girls with~     hyperandrogenemia (HA) are more insulin resistant (i.e., have lower insulin-stimulated~     glucose disposal) compared to obese peripubertal girls without HA; and that overnight mean~     luteinizing hormone (LH) concentration is also an independent predictor of free testosterone~     concentrations, especially in mid- to late pubertal girls.~   "
201224|NCT00928746|"~     The primary objective of this study is to evaluate the performance, accuracy, and handling of~     the actuation indicator in patients with COPD. The actuation indicator is integrated into~     mouthpiece of the ipratropium bromide HFA inhalation aerosol device. As part of Boehringer~     Ingelheim's program to qualify an actuation indicator for use with the ipratropium bromide~     HFA inhalation aerosol device, this study is intended to complement the results from the~     ongoing in-vitro studies.~   "
201225|NCT00928733|"~     Alcohol consumption is a major health problem worldwide. It affects all systems of the body~     especially the gastrointestinal tract. Acute or chronic alcohol consumption has deleterious~     effects on the gastrointestinal mucosa vary from increased intestinal permeability,~     structural changes to sever destruction of the epithelial lining cells. Human data are still~     limited and most of the studies were performed in chronic alcohol abusers.~      The investigators hypothesize that moderate alcohol drinking also may increase small~     intestinal permeability and contribute to the subsequent disruption of the tight junction~     complex. This study may provide more insight into the effects of moderate alcohol drinking on~     the small intestinal permeability.~   "
201226|NCT00928720|"~     The purpose of this study is to determine the effects of mild cranial electrical stimulation~     on pain, fatigue, sleep disturbances, perceived stress, blood pressure, and functional status~     in persons with fibromyalgia.~   "
201227|NCT00928707|"~     This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in~     combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia~     Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3~     months.~      Recruited patients will be randomly assigned to one of the following treatment groups:~        -  group A: 50 mg o.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum~          tolerated dose of hydroxyurea monotherapy already in use before admission to the study;~        -  group B: 50 mg b.i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum~          tolerated dose of hydroxyurea monotherapy already in use before admission to the study.~      The two groups will be balanced for number and for Centre in order to provide valuable~     information on both treatment regimens.~      In both groups assigned doses shall remain stable until week 12, which is when the primary~     endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.~      After the primary endpoint assessment at week 12, one of the following treatment schedules~     will be chosen case by case on the basis of the achieved clinical response and continued for~     up to 12 further weeks:~        -  Partial or Complete Response at week 12:~        -  group A: continue 50 mg o.d.;~        -  group B: continue 50 mg b.i.d.;~        -  No Response at week 12:~        -  group A: increase to 50 mg b.i.d.;~        -  group B: increase to 50 mg t.i.d.. At any time during study course, if toxicity is~          observed, GIVINOSTAT (ITF2357) treatment will be discontinued until recovery and then~          restarted at a reduced dose level. The drug will be definitively withdrawn in case of~          reappearance of toxicity even at a reduced daily dose. Overall, the treatment will last~          up to a maximum of 24 cumulative weeks of drug administration.~      The study will recruit subjects of both genders with an established diagnosis of JAK2V617F~     positive Polycythemia Vera according to the revised WHO criteria, in need of cytoreductive~     therapy, non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least~     3 months.~   "
201228|NCT00928694|"~     This study will determine definitive bioequivalence of the United States (U.S.) and United~     Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy~     adult subjects.~   "
201229|NCT00928681|"~     study to investigate the safety and efficacy properties of PF-00547659 in patients with~     active ulcerative colitis~   "
201230|NCT00928668|"~     The primary objective of this study is to assess the efficacy (bronchoprotection) and safety~     of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the~     Respimat® inhaler, in patients with intermittent asthma.~   "
201231|NCT00928655|"~     The purpose of the study is to investigate the effect of nasal continuous positive airway~     pressure in combination with acetazolamide as a treatment for sleep related breathing~     disturbances in patients with the obstructive sleep apnea syndrome living at low altitude~     during a sojourn at moderate altitude.~   "
201246|NCT00928460|"~     A preoperative electrocardiogram (ECG) is nearly routinely performed by anesthesiologists in~     elderly non-cardiac surgery patients as part of pre-anesthesia evaluation. However, the added~     value of this routine ECG beyond patient history and physical examination is questionable.~     The ECGtrial will investigate the efficacy of routine preoperative electrocardiography in~     patients undergoing non-cardiac surgery.~   "
201232|NCT00928642|"~     This study will evaluate the efficacy and tolerability of the combination of Gleevec and~     Gemzar in patients with ovarian cancer, who have progressed after receiving at least one~     prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and~     Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study~     will continue as long as the patient's tumors shrink or remain stable and as long as the~     patient is able to tolerate the study drug. The follow-up portion of the study will last for~     5 years.~   "
201233|NCT00928629|"~     The primary objective of the study is to establish the prevalence of lower extremity~     peripheral arterial disease (PAD), defined as an ankle-brachial index of less than or equal~     to 0.9, in subjects with at least two of the specified cardiovascular disease (CVD) risk~     factors, with no overt cardiovascular disease.~   "
201234|NCT00928616|"~     The purpose of this study is to evaluate the effects of a diet supplementation with plant~     sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.~   "
201235|NCT00928603|"~     Surgery and irradiation for organ confined prostate cancer provide excellent long-term cancer~     control but they may be accompanied by a risk of side effects that decrease quality of life.~     Due to the stage migration of prostate cancer, the potential for patients to undergo~     unnecessary treatment and the risk of treatment related morbidity, has been~     increased.Alternative strategies that offer the possibility of delaying, obviating or~     minimizing the impact of treatment maintaining the same oncological long term results have~     been investigated. Despite pros and cons active surveillance has not gained popularity in men~     with low risk prostate cancer as only 7% of men with localized prostate cancer remain in~     active surveillance.~      Traditionally solid tumors have been treated with radical surgery but selective, organ~     sparing therapies are now common for tumors of the breast, skin and kidney, resulting in~     equivalent rates of cancer control, lower morbidity rates and less disfigurement. With this~     in mind the potential role of focal ablative therapy for localized prostate cancer might be~     considered.~      The researchers will investigate the feasibility and the efficacy in term of quality of life~     and oncologic results of focal therapy by a pilot not randomized prospective study in a~     patients with localized prostate cancer who meet low risk criteria based on clinical, biopsy~     and imaging data.~   "
201236|NCT00928590|"~     The purpose of this study is to describe the long-term safety of a fixed combination product~     containing an alternative preservative, dosed once daily for 12 months, in patients with~     open-angle glaucoma or ocular hypertension.~   "
201237|NCT00928577|"~     Primary Objectives:~        -  To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed)~          in deploying military subjects who received ACAM2000® vaccine to rates among subjects~          positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do~          not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD~          healthcare providers) or due to conditions or characteristics of their contacts.~        -  To identify cases of subclinical myopericarditis in deploying military subjects who~          received ACAM2000 vaccine.~      Secondary Objectives:~        -  To compare the rates of severe and serious dermatologic adverse events observed in~          deploying military subjects who received ACAM2000® vaccine to rates among subjects~          positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do~          not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD~          healthcare providers) or due to conditions or characteristics of their contacts.~        -  To compare the rates of severe and serious neurological adverse events observed in~          deploying military subjects who received ACAM2000® vaccine to rates among subjects~          positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do~          not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD~          healthcare providers) or due to conditions or characteristics of their contacts.~        -  To compare the rates of adverse events observed in subjects approximately 10 days~          following their ACAM2000® vaccination to rates among subjects positioned to deploy who~          would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000~          vaccine due to recency of prior vaccination (as determined by DoD healthcare providers)~          or due to conditions or characteristics of their contacts.~        -  To evaluate potential risk factors associated with the development of confirmed,~          probable, and/or suspected ACAM2000-associated myopericarditis.~   "
201238|NCT00928564|"~     Pelvic floor tension myalgia (PFTM) is increasingly noted in patients with chronic pelvic~     pain. Pelvic floor physical therapy is typically utilized and is at times combined with other~     therapies such as botox injections, trigger point injections or pudendal blocks. The~     investigators' study will randomize newly diagnosed patients with PFTM to weekly physical~     therapy with weekly pudendal blocks or placebo saline injection. Participants randomized to~     physical therapy with placebo injections that have a visual analog scale score of greater~     than 4 at 6 weeks may cross-over to the pudendal block group. Final patient assessment will~     be performed at 6 months to assess durability of response.~      Primary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy~     will result in lower pain and pelvic floor muscle tension scores, lower baseline vaginal~     pressure and increase pelvic floor strength.~      Secondary hypothesis: The addition of pudendal blocks to standard pelvic floor physical~     therapy will result in a lower pain score in a shorter time frame, resulting in faster~     progress through physical therapy.~   "
201239|NCT00928551|"~     This study will compare two different formulations of vabicaserin.~   "
201240|NCT00928538|"~     The purpose of this study is to determine whether nurses can help at-risk women reduce the~     incidence of unintended pregnancy by providing them access to hormonal contraceptives in~     their homes.~   "
201241|NCT00928525|"~     The purpose of this study is to determine whether Imatinib Mesylate is active in diseases -~     such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived~     growth factor (PDGF) both in its isoform alpha and beta~   "
201242|NCT00928512|"~     This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in~     patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48~     with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457~     treatment in combination with MTX in RA.~   "
201243|NCT00928499|"~     Sacral Nerve Stimulation (SNS) delivers non-painful, mild electrical pulses to the sacral~     nerves to modulate the reflexes that influence the bladder, sphincter, and pelvic floor to~     improve or restore normal voiding function. Sacral nerve stimulation is indicated for~     refractory voiding dysfunction including urinary urgency/frequency, urinary urge~     incontinence, and nonobstructive urinary retention. Since its introduction, SNS has undergone~     significant improvements in design and application so that implantation is now a minimally~     invasive procedure under local and intravenous (IV) sedation. However, despite the progress~     made in advancing this therapy to a minimally invasive procedure, there are neither data nor~     guidelines on ideal program settings. The purpose of this study is to evaluate the~     programming parameter of cyclic versus continuous stimulation on efficacy of the therapy. If~     the therapy is equally efficacious at both settings, the cyclic setting has the advantage of~     resulting in a longer battery life.~   "
201244|NCT00928486|"~     To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients~     with previously treated multiple myeloma.~   "
201245|NCT00928473|"~     The Danish Childhood Obesity Biobank collects blood from obese and normal weighted children~     to produce a scientific platform for research in obesity.~   "
201247|NCT00928447|"~     The purpose of this study is to compare the effect and safety of rHuPH20 or placebo for the~     treatment of skin allergic reaction to nickel. The study drug and placebo will be~     administered by intradermal injection.~   "
201251|NCT00928395|"~     This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe~     and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have~     completed the 12 weekly treatments of the original protocol, the 13 week follow up~     assessment, be randomized to the PTNS arm, and be considered a positive responder with~     moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All~     consenting responders will continue with active PTNS therapy at an initially prescribed~     protocol for approximately 3 months followed by individualized symptom-based frequency of~     visits as determined by the subject along with their treating clinician, for up to a total of~     33 months post initial 12-week therapy for a total of 3 years.~   "
201252|NCT00928382|"~     One of the complications of having cancer in the spinal vertebrae is that it can spread and~     lead to compression of the spinal cord. Spinal cord compression is a serious event that needs~     to be treated quickly in order to prevent permanent damage to the spinal cord and nerves.~        -  Researchers currently do not have the ability to accurately predict whether cancer of~          the vertebrae will cause spinal cord compression. It is possible that accurate~          predictions could allow doctors to treat patients even before they develop symptoms of~          spinal cord compression, thereby preventing some of the long-term consequences.~      Objectives:~        -  To compare patients with cancer of the spinal vertebrae with and without symptoms of~          spinal cord compression by looking at markers in the blood and changes on novel magnetic~          resonance imaging (MRI) techniques that might allow researchers to predict who will~          experience spinal cord compression before they actually begin to have symptoms.~      Eligibility:~        -  One group of healthy volunteers 18 years of age and older.~        -  One group of patients 18 years of age and older who have cancer that has spread to the~          vertebrae without symptoms of spinal cord compression.~        -  One group of patients 18 years of age and older who have cancer that has spread to the~          vertebrae with symptoms of spinal cord compression.~      Design:~        -  Healthy volunteers:~        -  Blood will be drawn from each volunteer for initial tests and for more specific~          biomarker tests.~        -  Comprehensive MRI of the spine, followed by a special type of MRI called diffusion~          tensor imaging (DTI). It is believed that DTI may be even more sensitive in revealing~          spinal cord abnormalities than regular MRI sequences.~        -  Patients with cancer of the vertebrae:~        -  Researchers will obtain information such as pathology reports, laboratory results,~          diagnosis and treatment history, physical exam (PE) information, results of scans such~          as x-rays, MRI, computerized tomography (CT), and positron emission tomography (PET),~          and planned treatment details.~        -  Additional blood samples will be taken for specific biomarker tests.~        -  Questionnaire about pain, unusual sensations or numbness, bladder or bowel problems, and~          mobility.~        -  Comprehensive MRI of the spine, followed by a DTI.~        -  Patients who appear to have symptoms of spinal cord compression will be offered standard~          radiation treatment.~   "
201253|NCT00928369|"~     Young patients with adnexal lesions may have variable presenting symptoms. In this study, we~     reviewed the clinical characteristics of young Korean patients who took the operation in~     university hospital with adnexal lesions over the past 14 years.~   "
201254|NCT00928356|"~     The primary objective of this study is to assess the safety and effectiveness of same~     sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and~     percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary~     artery disease. A secondary objective is the assessment and standardization of optimal~     operator techniques and comparative study of patients undergoing CABG during study period.~   "
201255|NCT00928343|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)~     subcutaneous and single oral dose of GLPG0187 compared to placebo.~      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous~     and oral administration will be evaluated, and, if applicable, the maximum tolerated dose~     determined.~   "
201256|NCT00928330|"~     This multicenter, Phase Ib study is an open label, dose escalation, three-arm study~     evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941~     administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of~     trastuzumab.~   "
201257|NCT00928317|"~     The purpose of this clinical trial is to assess the safety, efficacy, tolerability,~     immunogenicity and pharmacokinetics of 3 dose levels of ART621 in the treatment of rheumatoid~     arthritis.~   "
201258|NCT00928304|"~     To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting~     cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals~     without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the~     age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.~   "
201259|NCT00928291|"~     In this study the investigators aim to test if a procalcitonin (PCT) - guided strategy allows~     to reduce the antibiotic use in patients with febrile neutropenia hospitalized in a Brazilian~     tertiary university hospital, causing no harm.~   "
201260|NCT00928278|"~     The purpose of this study is to investigate the time course of PF-04764793 concentration in~     the blood following dosing by oral inhalation from dry powder inhalers.~   "
201261|NCT00928265|"~     This is a prospective observational multicenter registry to evaluate safety and efficacy data~     on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an~     intent to treat basis.~      The objectives of this study are:~        1. Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of~          the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the~          modified Rankin scale (mRS).~        2. to evaluate adverse events.~        3. Angiographic assessment at 12-18 months compared to the initial post-treatment~          assessment via the modified Raymond scale and same/better/worse scale.~   "
201262|NCT00928252|"~     The purpose of this study is to determine whether imaging with 18F-choline PET/CT can provide~     information that may help guide subsequent investigational or clinical treatments for~     patients with advanced (hormone-refractory) metastatic prostate cancer.~   "
201263|NCT00928239|"~     The purpose of this study is to compare postoperative complications and outcome two different~     attachment sites of the dorsal mesh support in laparoscopic sacropexy.~   "
201264|NCT00928226|"~     The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery to treat~     brain metastases greater than 4.2 cm3 in size will be determined.~      This study investigates if increasing radiation dose improves outcome for patients without~     greater toxicity (side effects).~   "
201265|NCT00928213|"~     Assessment of biochemical and sonographic marker to predict the risk for developing~     preeclampsia Among biochemical markers are serum level of Placental Protein 13 (PP13) and~     Placenta Growth factor (PIGF). For sonographic marker Doppler pulsatility Index of the blood~     flow through the uterine maternal arteries is assessed.~      PP13 is produced by the placenta and released to the maternal blood circulation. It has been~     shown to be an effective serum marker for early onset preeclampsia (Nicolaides KH et al.,~     2005). The purpose of this study is to combined the assessment of the biochemical markers~     with Doppler in the first and the second trimester to provide a comprehensive evaluation of~     various methods for sequential and combined analysis to assess the risk for developing~     preeclampsia.~   "
203082|NCT00904072|"~     The purpose of this study is to understand the impact of CDSS by knowing the prescribers~     actions to the CDSS, also the influence of prescribing error announced by pharmacists.~   "
201266|NCT00928200|"~     This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form~     using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients~     with relapsed ALL who have developed an allergy to the E. coli formulation. This study will~     administer the drug intravenously instead of the usual intramuscular route. The dose of~     Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first~     or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.~   "
201267|NCT00928187|"~     Since the first line antiretroviral (ARV) treatment is now largely accessible in the~     Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns~     and second line treatment evaluation are still to be consolidated in settings where viral~     load monitoring is not available and non-B HIV subtype is predominant.~      This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment~     strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor~     associated with a ritonavir boosted protease inhibitor~     (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir);~     the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet~     evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a~     better tolerance and its single daily administration may facilitate treatment adherence.~   "
201268|NCT00928174|"~     The purpose of this study is to determine whether positron emission tomography / computed~     tomography (PET/CT) using fluorine-18 fluorocholine as an imaging agent can characterize~     regional responses to anti-androgen therapies in a manner that in the future aid in the~     customized planning of treatments for patients with androgen-insensitive prostate cancer.~   "
201269|NCT00928161|"~     The goal of this clinical research study is to learn if radiation-induced xerostomia [RIX]~     (dry mouth) causes, or worsens the effects of, acid reflux (heartburn and heartburn-like~     symptoms) in head and neck cancer (HNC) patients receiving radiation therapy.~      Objectives:~      Primary Objective:~      Determine if radiation induced xerostomia (RIX) increases the frequency or duration of~     acid-reflux when re-measured approximately 6-12 weeks after RT (measured by # episodes, their~     duration, and Reflux Area Index (RAI). Reflux Area (RA) is the sum of the area under the~     curve for all episodes of pH<4 recorded during the study in units of Ph*minutes. The Reflux~     area index (RAI) is the RA corrected for the duration of the study (RA x 100/study duration).~      Secondary Objectives:~        1. To demonstrate that patients undergoing RT for OPC have reflux into the irradiated field~          that is anticipated to exacerbate mucositis symptoms~        2. Correlate RAI and # episodes of acid reflux with salivary flow before and after RT to~          determine if radiation induced hyposalivation is associated with more reflux events and~          symptoms.~        3. For patients with no pre-RT pathologic acid reflux, determine if RIX leads to conversion~          to acid-positive reflux measured approximately 6-12 weeks after RT.~        4. Correlate office indirect laryngoscopy findings (posterior commissure thickening,~          cobble-stoning, granulomas, and arytenoids erythema or edema) suggestive of acid reflux~          in OPC patients with pH-probe findings as was done in larynx cancer (Lewin et al)~        5. Compare findings from the patient reported outcome (PRO) instruments used~   "
201270|NCT00928148|"~     This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover~     study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg)~     compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults~     with ADHD. The controlled environment used in this study is an analog classroom setting~     adapted for a 16-hour adult day.~   "
201271|NCT00928135|"~     Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and~     recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt~     concentration has been shown to increase activity of salt sensitive antimicrobial peptides.~      Xylitol is a 5-carbon sugar that can lower the ASL salt concentration, thus enhancing innate~     immunity. In this study, the investigators propose to test the safety and tolerability of~     aerosolized xylitol used daily for 2 weeks in subjects with cystic fibrosis. In a pilot,~     2-week study, 60 subjects with cystic fibrosis with an FEV1(Forced expiratory volume in 1~     second ) >30% predicted will be randomized to receive aerosolized 7% hypertonic saline (5 ml)~     or 15% xylitol, (5 ml) twice a day for 14 days. The primary outcomes will be safety as~     assessed by FEV1 change from baseline, adverse events and respiratory symptom score. Outcomes~     for trend in efficacy include density of colonization of sputum, time to next exacerbation,~     sputum cytokines and revised CF quality of life questionnaire.~   "
201272|NCT00928122|"~     This study evaluates the intrastromal correction of ametropia with a femtosecond laser made~     by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which~     enables very precise cuts in the cornea. By these cuts lamellae of the cornea are separated~     locally, and in the consequence the curvature of the cornea is changed, and the correction of~     the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a~     sharp knife, the cuts generated when using a laser can be generated just inside the cornea~     without opening the surface of the cornea. This means the procedure is minimal-invasive.~      The study hypothesis is: Different types of ametropia can be corrected safely and on~     long-term by intrastromal cuts.~   "
201273|NCT00928109|"~     UCAN is a research program funded by the National Institute of Mental Health and is part of~     the UNC Eating Disorders Program. UCAN aims to help couples work together in the treatment of~     anorexia nervosa. Couples participate in UCAN over a period of six months and return for~     follow-up treatment three months after the end of the original six-month period. Patients~     receive weekly individual therapy, monthly psychiatry consultations, monthly dietary~     consultations in addition to being randomized to one of two types of weekly couples therapy.~     Participation in UCAN can help participants gain new confidence in facing anorexia as a team~     and can help us understand how best to involve partners in the treatment of eating disorders.~   "
201274|NCT00928096|"~     In this study, radiation therapy plans will be made for 20 consecutive patients with~     mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphoma. One plan is done using a~     breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan and another~     plan is done using the standard procedure with pre-chemo PET-CT fused with post-chemo~     planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in~     each patient. The best radiation therapy plan will be used to treat the patient.~   "
201275|NCT00928083|"~     OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent.~      This was a Phase I, single-centre, multi-component, double-blind, randomised,~     placebo-controlled study in healthy male and female subjects. The study was conducted in 3~     parts:~        -  Part A investigated the safety, tolerability and pharmacokinetics (PK) of single oral~          escalating doses of OZ439. Up to 6 dose levels will be investigated to estimate dose~          proportionality.~        -  Part B, the effect of food on a single oral dose of OZ439 was investigated in a 2-way~          crossover design.~        -  Part C investigated the safety, tolerability and PK profile of multiple oral doses of~          OZ439.~      The starting oral dose was 50 mg and the maximum single dose to be administered did not~     exceed 1600 mg per subject. The maximum duration of dosing proposed was 3 days.~   "
201276|NCT00928070|"~     This study is designed to assess the efficacy and safety of a flexible dose regimen of~     fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects~     with overactive bladder (OAB).~   "
201277|NCT00928057|"~     Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin~     therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy~     profile of currently marketed pen needles may appeal to many diabetic patients as the new~     needle may be perceived as less intimidating and more comfortable. Currently marketed pen~     needles range in length from 5 to 12.7 millimeters (mm).~      The primary purpose of this study was to evaluate whether the investigational 4mm x 32~     Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent~     glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G~     and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.~   "
201278|NCT00928044|"~     Besides the removal of lesions, the purpose of surgeries has been extended to the improvement~     of quality of life after procedures. Minimally invasive surgeries enabled women to experience~     less pain, less hospital days. It is important to maintain the ovarian function because~     ovarian hormones have protective effects about bone and cardiovascular diseases. Until now~     many operation techniques for preserving ovarian function were used in gynecological field,~     however, how much these methods affect on ovarian function is seldom known. For the~     evaluation of remained ovarian function, ultrasound examination is useful method. However, it~     might take several months till one can determine ovarian function and could not exactly~     evaluate ovarian reserve. Until now, there have been controversies regarding ovarian function~     after gynecological surgeries. These inconsistent results might derive from the methods for~     assessing ovarian function because serum gonadotropins and sex steroids levels vary according~     to the menstrual cycle.~      In this aspect, anti-Müllerian hormone (AMH) has recently been advocated as a good marker for~     ovarian reserve. AMH is one of the TGF-beta superfamily and induces the regression of~     Müllerian duct. Studies with AMH showed no significant variation throughout the menstrual~     cycle and cycle-to-cycle consistency, therefore, it will provide more reliable data on the~     changes of ovarian reserve after operations.~   "
201279|NCT00928031|"~     The objective of this study is to collect disease status and overall survival information for~     all Subjects in MDX-010 studies.~   "
201280|NCT00928018|"~     This trial is comparing whether using a drug called sirolimus for graft versus host disease~     (GVHD) prevention can decrease the chance of the participant's lymphoma relapsing after~     transplantation, compared to using a standard GVHD prevention regimen without sirolimus.~     Since mTOR inhibitors have anti-lymphoma activity, their use after transplantation may lead~     to a decreased risk of relapse and hence better transplantation outcome.~   "
201281|NCT00928005|"~     Type 2 diabetes and prediabetes, which are mainly caused by a lack of physical activity and~     excess weight, put people at an increased risk of cardiovascular disease. This study will~     compare the effects of a weight loss diet versus a weight loss diet plus an exercise program~     on body composition and cardiovascular factors that are early predictors of future~     cardiovascular disease in overweight and obese people with type 2 diabetes and prediabetes.~   "
201282|NCT00927992|"~     This study will analyze survival and outcome of patients with severe haemophilia who undergo~     liver transplantation in Spain~   "
201283|NCT00927979|"~     In our prospective, randomized, placebo controlled and double-blinded study we will study the~     efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecologic~     laparoscopic surgery. This is a second steady with protocol of general anesthesia used of~     Remifentanil.~   "
201284|NCT00927966|"~     The purpose of this research study is to determine the safety of the combination of RAD001~     and CP-751,871, as well as the highest dose of this combination that can be given to people~     safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally.~     This drug has been extensively studied in many cancers. In particular, it has shown to be~     effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered~     drug that may stop tumor growth. It is currently being studied in a wide variety of cancers,~     and information from those other research studies suggests that these two drugs in~     combination may help to stop cancer growth.~   "
201285|NCT00927953|"~     This study will test a drug called MGAWN1 for the treatment of West Nile infections.~   "
201286|NCT00927940|"~     The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting~     Coronary Stent for the treatment of de novo lesions in native coronary arteries.~   "
201287|NCT00927927|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and~     signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002~     in patients with rheumatoid arthritis.~   "
201288|NCT00927914|"~     The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on~     peroneal motor nerve conduction velocity relative to placebo in subjects with mild to~     moderate diabetic sensorimotor polyneuropathy.~   "
201289|NCT00927901|"~     This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate,~     xinafoate and acetate) in patients with asthma.~   "
201290|NCT00927888|"~     The aim of the study is to quantify postoperative pain after functional endoscopic sinus~     surgery (FESS) and investigate whether preemptive analgesia may positively impact~     intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and~     improve patient functional outcomes.~   "
201292|NCT00927862|"~     The purpose of this study is to determine whether DNA analysis improves the efficiency of~     dosing and safety in patients who are being started on warfarin therapy.Warfarin, a blood~     thinner (anticoagulant) prescribed to 1-2 million patients in the United States, is a leading~     cause of drug-related adverse events (e.g., severe bleeding), in large part due to dramatic~     (20-fold) differences between individuals in dose requirements. At least half of this~     variability now can be explained by 3 common genetic variants, age, body size, and sex;~     however, warfarin therapy continues to begin with the same dose in every patient with the~     correct individual dose determined by trial and error. This study proposes to determine~     genetic variations the same day from DNA simply obtained by swabbing the inside of the cheek~     and use this information to determine the proper dose regimen individually in each patient.~     The aim is to show that the investigators can achieve more rapid, efficient, and safe dosing~     in up to 500-1000 individuals who are initiating warfarin therapy for various clotting~     disorders across a large healthcare system in order to demonstrate improved dosing~     effectiveness, efficiency, and safety with genetic-based dosing, which could lead to a~     nationwide application resulting in as much as a $1 billion dollar annual benefit in~     healthcare outcomes.~   "
201293|NCT00927849|"~     Idiopathic hypertensive anal canal is a fact and already exists presented by anal pain~     aggravated by defecation. It can be managed safely by closed lateral sphincterotomy but~     chemical sphincterotomy had a minor role in its management.~   "
201294|NCT00927836|"~     The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of~     acute ischemic stroke and to assess the safety and tolerability of AX200.~   "
201295|NCT00927823|"~     A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of~     PF-04691502 in adult cancer patients with solid tumors.~   "
201296|NCT00927810|"~     This 24-week open-label extension study is designed to provide additional long-term safety~     data up to a total of 1-year for patients rolling over from the core study, and to collect~     further efficacy and tolerability data for all the patients, irrespective whether they have~     an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885)~     in this extension study.~   "
201297|NCT00927797|"~     The combination of Fludarabine and Cyclophosphamide have yielded overall response rates of~     over 80% in previously untreated patients with indolent Non-Hodgkin-Lymphoma. However,~     hematotoxicity rates were high with Grade 3 and 4 toxicities of over 50%. Several studies~     have indicated that the treatment with Pentostatin and Cyclophosphamide causes lower~     hematotoxicity rates than the combination of Fludarabine and Cyclophosphamide. To evaluate~     the efficacy and safety of treatment with Pentostatin/Cyclophosphamide immuno-chemotherapy~     for patients with newly diagnosed or relapsed Immunocytoma/Morbus Waldenström, B-cell chronic~     lymphocytic leukemia (B-CLL) and other indolent CD20-positive B-NHL, an open, non-randomized,~     multi-center prospective phase II-study to evaluate the efficacy and safety of treatment with~     immuno-chemotherapy is conducted. Treatment consists of 6 courses of Pentostatin (4mg/m² on~     day 1), Cyclophosphamide (600mg/m² on day 1) and Rituximab (375mg/m² on day 0) administered~     every three weeks. Patients achieving complete or partial remission undergo maintenance~     therapy consisting of 8 courses of Rituximab (375mg/m²) administered every three months over~     a period of 2 years.~   "
201298|NCT00927784|"~     Left ventricular assist devices (LVADs) are one treatment option for people with congestive~     heart failure. This study will evaluate the safety of injecting mesenchymal precursor cells~     (MPCs) into the heart during LVAD implantation surgery and examine if injecting MPCs into the~     heart is effective at improving heart function.~   "
201299|NCT00927771|"~     The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to~     Hydroquinone Cream in the treatment of melasma.~   "
201300|NCT00927758|"~     To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with~     inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for~     Asthma (GINA) guidelines.~   "
201301|NCT00927745|"~     The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical~     ventilation in ICU patients~   "
201302|NCT00927732|"~     The specific aim of this study is to determine whether hydroquinidine administration can~     prevent heart from appearance of ventricular arrhythmia detected by the automatic implantable~     defibrillator (ICD).~   "
201303|NCT00927719|"~     This is an enhanced safety surveillance study that will occur within the military Service~     Member population.~      Primary Objective:~        -  To evaluate the rates of suspected, probable, and confirmed myocarditis and/or~          pericarditis in temporal association with ACAM2000® vaccination.~      Secondary Objectives:~        -  To evaluate the rates of cardiovascular adverse events in temporal association with~          ACAM2000® vaccination.~        -  To evaluate the rates of neurological adverse events in temporal association with~          ACAM2000® vaccination.~   "
201304|NCT00927706|"~     The purpose of this study is to determine the effectiveness of an assistive technology~     updating and tune up intervention on users and their caregivers. This intervention includes 4~     components:~        -  an in-residence assessment of the mobility preferences of the older person and his/her~          caregiver~        -  a detailed review of forms of assistance, technological and human, that are currently~          being used~        -  recommendations by an occupational therapist for possible changes in the older person's~          mobility assistive technology or assistance strategy~        -  therapist negotiation of an mobility assistive technology updating and tune-up~          intervention plan with the individual and his or her caregiver. The intervention is~          provided to the immediate treatment following the administration of baseline measures~          and the delayed intervention group six weeks later, after an additional baseline~          measurement. The treatment is six weeks long and the follow-up is 26 weeks.~      Hypothesis 1: For community-dwelling older people, an intervention that increases the~     appropriateness of existing or new assistive technology(AT) for mobility or self-care will~     alter established patterns of human assistance, such that caregiver burden is reduced or~     eliminated.~      Hypothesis 2: At the same time, AT users will report less difficulty in mobility or~     self-care, as well as enhanced subjective well-being, and satisfaction with their modified~     personal assistance strategy.~      Hypothesis 3: Following the AT intervention, caregivers will report reduced physical and/or~     psychological demands and increased satisfaction with their caregiving-related activities~     compared with~        -  the pre-intervention period~        -  caregivers in a delayed intervention control group. Hypothesis 4: Decreased physical~          and/or psychological demands on helpers will be associated with increases in device~          users' satisfaction with their personal assistance strategies.~   "
201305|NCT00927693|"~     Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research (EISNER)~     is a multi-study research program being conducted at Cedars-Sinai Medical Center.~      The principal objective of this randomized trial (referred to as Study 1) is to assess~     whether coronary artery calcium (CAC) scanning provides clinical benefit thus improving~     patient outcomes in asymptomatic subjects with intermediate coronary artery disease (CAD)~     risk. Additionally, the study is designed to assess the value of combining the CAC scan with~     the Framingham risk score (FRS) and measurements of serum or plasma biomarkers to predict~     outcomes.~   "
201306|NCT00927680|"~     Colorectal cancer (CRC) is the second leading cause of cancer in Puerto Rico (PR) accounting~     for approximately 1,500 individuals annually, which represent 12% of all cancer cases in the~     island. The genetic epidemiology of CRC among Hispanic populations is not well studied, hence~     studies focused on large, well defined ethnic groups such as Puerto Ricans, are clearly~     warranted. The first step towards evaluating the molecular, environmental, and genetic~     epidemiology of CRC in PR is to establish a population-based familial CRC registry. The~     following specific aims have been proposed:~      Specific Aim 1: To prospectively identify and recruit approximately 300 CRC probands from two~     distinct geographical areas in PR (Metropolitan and Southern Region). From each proband the~     investigators will obtain a pedigree extended to second-degree relatives and cousins.~     Assuming 10% will be positive for a family history of CRC, the investigators will then~     recruit all 30 probands with a family history of CRC and a sample of 15 family-history~     negative probands and obtain: paraffin-embedded tumors blocks, blood samples, risk factor and~     food frequency questionnaires.~      Specific Aim 2: To prospectively identify and recruit selected relatives (parents,~     grandparents, and same generation relatives - cousins and siblings) from the 45 probands~     identified in Specific Aim 1. In addition, for siblings and cousins of probands (i.e.~     relatives in the same generation as the proband), the investigators will obtain risk factor~     and food frequency questionnaires, and for colorectal cancer cases, tumor blocks and~     pathology reports of their cancers.~      Specific Aim 3: To estimate from this pilot study the following parameters: (a) response rate~     of probands and their selected relatives; (b) response rate of participants for each data~     item; (c) family history of CRC and other cancers; (d) number of living first- and~     second-degree relatives and cousins of probands; (e) number of these relatives who live in~     the same household and region/municipality; (f) prevalence/distribution of selected risk~     factors from the administered questionnaires.~   "
201307|NCT00927667|"~     The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little~     blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging~     session. No study medication is given.~   "
201308|NCT00927654|"~     In this study effects of the intra operative, prophylactic inhalation of Iloprost (Ventavis)~     before and during extracorporal circulation on perioperative morbidity and outcome in high~     risk cardiac surgical patients is investigated in comparison to placebo.~   "
201309|NCT00927641|"~     The objective of this study is to demonstrate the multiple-dose efficacy and safety of~     HKT-500 for the treatment of ankle sprain.~   "
201310|NCT00927628|"~     The purpose of this investigation was to determine the incidence and the factors that cause a~     reopening of a macular hole (MH) after a surgical closure.~   "
201311|NCT00927615|"~     The primary objective of this study is to investigate whether intracoronary bolus~     administration of abciximab is superior to intravenous bolus administration in improving~     myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing~     primary percutaneous coronary intervention.~   "
201312|NCT00927602|"~     Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous~     thromboembolism in high risk medical patients. A relevant proportion of medical patients have~     moderate to severe renal insufficiency, which is an independent risk factor for bleeding.~     This risk may be further increased when low molecular weight heparin or fondaparinux are~     administered in patients with severe renal insufficiency, defined by a creatinine clearance~     of lower than 30 mL/min. No clear indications are available to reduce such risk in patients~     who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently~     approved for the prevention of venous thromboembolism in the specific population of patients~     with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization).~     However, there are to our knowledge no clinical studies that have assessed the safety and~     efficacy of this reduced dosage in medical patients.~   "
201313|NCT00927589|"~     This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect~     of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin~     pharmacokinetics in patients with HER2-positive metastatic or locally advanced inoperable~     cancer.~      The QT interval is a measure of time between the start of the Q wave and the end of the T~     wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated~     using Fridericia's correction; the QTcB interval is the QT interval as calculated using~     Bazett's correction.~   "
201314|NCT00927576|"~     The investigators evaluated whether it was possible to improve the measurement of memory,~     attention, and executive function in patients who have suffered traumatic brain injury~     through the use of computer-based testing.~      Note: the original design of the study was altered due to failure to recruit sufficient~     numbers of patients who were willing to undergo prolonged cognitive training.~   "
201315|NCT00927563|"~     The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in~     pathological gambling.~   "
201316|NCT00927550|"~     The principal clinical question is whether lithium is effective in reducing the risk of~     suicidal behaviour in subjects with treatment-resistant depression and suicide risk.~     Additionally aims of the study are: (a) to assess whether lithium is effective in improving~     depressive symptomatology in subjects with treatment-resistant depression and suicide risk;~     (b) to assess the tolerability profile of lithium.~   "
201317|NCT00927537|"~     The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed~     over 3-4 months~   "
201318|NCT00927524|"~     Intensive control of Type 1 Diabetes is critical in prevention of long term complications.~     Unfortunately, there is a three-fold increase in hypoglycemia with intensive control.~     Hypoglycemia is often the major limiting factor in achieving good control. Insulin treatment~     of diabetes is composed of some form of short acting insulin regimen in order to provide~     control of blood glucose excursions that are the result of glucose intake as well as a basal~     insulin regimen either in a continuous administration (as in continuous subcutaneous insulin~     infusion-pump therapy), once a day injection (insulin Glargine), twice a day (ultralente or~     NPH or lente insulin) or a premixed version that is combined with the short acting insulin~     (70/30 or 75/25). Often low blood sugars are the result of less physiologically absorbed~     insulins whose peak of action is earlier or later than the peak absorption of glucose from a~     meal.~      Apidra (glulisine insulin) is a new short acting insulin analogue whose peak and duration of~     action are ideal in that it may be administered more appropriately prior to and even after a~     meal with evidence of good control of blood glucose excursions from a meal. The purpose of~     this study is to compare the effect of Apidra upon meal related blood glucose profile as~     compared to those treated with 70/30 insulin in patients with Type 1 Diabetes. The~     investigators also will study healthy volunteers as controls who will not be treated with~     insulin but will be evaluated for mealtime absorption and blood glucose profile during~     similar meal intake. The investigators will use a stable isotope tritiated glucose.~   "
201677|NCT00922636|"~     The primary purpose of your child's participation in this study is to determine whether~     LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD);~     and assess the safety of LY2216684 and any side effects that might be associated with it.~   "
201319|NCT00927511|"~     In post-menopausal metastatic hormone-responsive breast cancer women.~      This study is a two arm randomized trial to evaluate the effectiveness of dose-titration~     regimen of fulvestrant compared with the approved dosing regimen. Patients will be randomized~     to one of the following treatment arms:~      Arm A: Fulvestrant 500 mg days 0, 14, 28, then 250 mg every 2 weeks for 5 administrations,~     then 250 mg every 28 days, until progression or unacceptable toxicity Arm B: Fulvestrant 250~     mg every 28 days until progression or unacceptable toxicity~   "
201320|NCT00927498|"~     The main objective of this study is to compare conventional chemotherapy: daunorubicin and~     the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg~     in divided doses.~   "
201321|NCT00927485|"~     Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the~     formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually,~     all patients with FAP will develop colorectal cancer on average by the 5th decade of life if~     prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer~     surveillance of the remaining colorectum or ileum.~      Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which~     selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2~     (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the~     rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with~     significant comorbidity including renal and gastric toxicity and increased risk of vascular~     events. Therefore, identification of a chemopreventive agent that would have similar efficacy~     but less toxicity would enhance our ability to treat these patients. Therefore the following~     specific aim has been proposed:To determine in a randomized, double-blinded,~     placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal~     adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients~     with FAP.~   "
201322|NCT00927472|"~     In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for~     head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an~     established head lice treatment. The new formulation has been evaluated in 2 previous studies~     of patients 2 years of age and older.~   "
201323|NCT00927459|"~     This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human,~     single-ascending dose study in male and female subjects with high cholesterol. A maximum of~     32 subjects is planned for enrollment in this study.~   "
201324|NCT00927446|"~     Patients with head and neck cancer frequently develop synchronous or metachronous esophageal~     malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for~     esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an~     optical technology that enhances the visualization of superficial vascular network, may be~     superior to the conventional white light endoscopy for the detection of neoplastic lesions.~     However, whether the application of NBI improves the detection results have not been~     critically evaluated.~      This study aims to investigate the diagnostic value of the NBI system in the endoscopic~     screening for esophageal neoplastic lesions in patients with head and neck cancer.~   "
201325|NCT00927433|"~     Background: Result from an earlier study I carried out in the late 1990 showed that cancer~     patients were overall well informed about diagnoses, prognoses, symptoms, treatment,~     side-effects of treatment e.g. pain, nausea and vomiting and hair loss. Their knowledge about~     fatigue as a side -effect to cancer and cancer treatment was however different. Patients had~     minimal knowledge about fatigue and they were not prepared for this side-effect and as a~     result of this they did not know how to handle fatigue and fatigue was seen as a very~     frightening experience.~      As a result of the findings I wanted to carry out an intervention study, where the aims were~     to develop an educational programme about fatigue and to evaluate the effect of the~     programme.~      Purpose: The purpose of the project is to develop and describe a structured educational~     programme. The structured educational programme will serve as the intervention. The purpose~     is also to evaluate whether or not the structured educational programme increase the cancer~     patients knowledge about cancer related fatigue and to find out if increased knowledge about~     cancer related fatigue ease the experience of cancer related fatigue.~      Another purpose of the study is to investigate the connection between fatigue and other~     symptoms and to find out how other symptoms influence the patients experience of fatigue.~      The study will consist of 3 stages.~        -  Development of structured educational programme~        -  Implementation of structured educational programme~        -  Evaluation of the effect of the structured educational programme~      Materials and methods: The study is a randomised experimental design. An intervention group~     and a control group, each consisting of 100 Breast Cancer patients (Stadium I or II)~     receiving chemotherapy or/and radiation therapy after surgery are included in the study. On a~     NR-scale (0-10) the patients had a fatigue score of 2,5 or more to be included in the study.~      The intervention is an educational package of 120 minutes x 3 over three weeks. The~     intervention is given in groups of 10 patients. Both groups are responding to questionnaires~     just before the intervention, just after the intervention and three months after finishing~     the intervention. The educational package consisted of basic knowledge about fatigue, and~     strategies or techniques for coping with fatigue.~   "
201326|NCT00927420|"~     The purpose of this study is to estimate adherence to treatment in bipolar patients, to~     characterize patients based on adherence degree and to describe the variables linked to poor~     adherence to treatment in real-life practice.~   "
201327|NCT00927407|"~     In this study, 24 adult patients with head lice will be treated with a topical malathion head~     lice treatment; 12 patients will be treated with a novel product, Malathion Gel, 0.5%, and~     other 12 patients will be treated with Ovide Lotion 0.5% marketed by Taro Pharmaceuticals~     USA, Inc. The primary objective of this study is to compare the blood level exposure of~     Malathion 0.5% Gel to that of the OVIDE Lotion 0.5%.~   "
201328|NCT00927394|"~     The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the~     combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy~     in Type II Diabetic patients with Stage II hypertension.~   "
201329|NCT00927381|"~     Retrospective observational review of severe envenomation treatment with CroFab~   "
201330|NCT00927368|"~     This is a randomized study which will compare three femoral nerve catheter insertion~     techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided~     femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2:~     ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating~     catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.~   "
201331|NCT00927355|"~     We will prospectively study 2 groups of diabetic patients treated with pioglitazone or~     placebo for 26 weeks. Bone marrow aspirates will be obtained from these patients at baseline~     and after 26 weeks of treatment, and hBMCs will be isolated from these bone marrow~     aspirations. The ability of hBMCs to differentiate into osteoblast and adipocytes lineages~     will be compared before and after treatment with pioglitazone and compared to placebo. In~     parallel, clinical markers of bone formation and resorption as well as bone mineral density~     will be assessed before and after 26 weeks of treatment. Primary endpoint for this study will~     be detection of change in number of osteoblasts or adipocytes from cultured hBMCs between~     study groups and within each group.~   "
201332|NCT00927342|"~     Following lung surgery air may continue to leak from the surface of the lung. Chest drains~     are placed to allow this air to be removed safely and prevent the lung from collapsing.~     Drains need to remain until the air leak from the lung has ceased.~      Air which continues to leak results in longer chest drainage times which cause increased~     discomfort and immobility for patients. These patients are at risk of secondary complications~     such as infection. Longer hospital stays and increased costs ensue. A randomised controlled~     trial (RCT) conducted at The Royal Brompton Hospital has shown clear benefits in the~     management of difficult air leak with the use of BioGlue. BioGlue is a surgical sealant~     applied to the surface of the lung at the time of surgery.~      BioGlue is of bovine origin. Concerns exist regarding the potential risk of transmission of~     blood borne diseases with bovine derived medical products. Should a surgical adhesive without~     these potential risks prove as effective as BioGlue then its use could be commended.~      The Vivostat System is a medical system that derives a sealant from the patient's own blood.~     A small study has shown that it may also be of benefit in the management of difficult air~     leaks. The principal aim of our RCT is to compare the duration of air leak, length of chest~     drainage and hospital stay associated with BioGlue to that of Vivostat.~   "
201333|NCT00927329|"~     The purpose of this study is to serve as a pilot safety study for nasal allergen challenges.~   "
201334|NCT00927316|"~     This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli~     83972) protect against symptomatic urinary tract infections in individuals with bladder~     emptying dysfunctions and prone to recurrent infection episodes? The study is performed using~     a double-blind randomized study protocol with a cross-over, with re-inoculations being~     patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had~     bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded~     inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients~     are unaware of urine culture results.~   "
201335|NCT00927303|"~     Retinal thickness measurement is one of the most important examinations in the follow up of~     exudative age-related macular degeneration. Prior studies have shown that there are a series~     of algorithm line failures in OCT examinations. This study is conducted to compare the~     quality of the examinations of to different spectral domain OCT machines concerning the~     positioning of algorithm lines. Furthermore the reproducibility of the examinations id~     tested, both machines provide different techniques to guarantee that in repeated examinations~     the same location is examined.~   "
201336|NCT00927290|"~     The purpose of this study is to test whether the correction of insulin resistance with~     pioglitazone, will improve the response to antiviral treatment.~   "
201337|NCT00927277|"~     The purpose of this study is to determine whether low level laser therapy can help the~     recovery process for the procedure of liposuction of the thighs, hips and stomach.~   "
201338|NCT00927264|"~     Environmental tobacco smoke (ETS0, also known as secondhand smoke, is the combination of~     smoke given off by the burning end of a tobacco product and the smoke exhaled by the smoker.~     Children exposed to ETS are at an increased risk of sudden infant death syndrome (SIDS), ear~     infections, colds, pneumonia, bronchitis and more severe asthma. ETS can also slow the growth~     of children's lungs and can cause them to cough, wheeze and fell breathless. The purpose of~     this study is to determine the effectiveness of a motivational interviewing-based program in~     reducing ETS exposure and improving lung health among children who are enrolled in a Head~     Start program and whose households include a smoker.~   "
201339|NCT00927251|"~     This study is designed to show that a new lead, which paces the left bottom chamber (left~     ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown~     to potentially improve heart failure symptoms. The shape and size of this new lead may make~     it a good choice for patients or physicians.~   "
201340|NCT00927238|"~     The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients~     with single-level degenerative disc disease compared to other devices approved by the FDA for~     the same or similar indications.~   "
201341|NCT00927225|"~     Local infiltration analgesia is effective in total knee arthroplasty for postoperative pain~     management, but the efficacy of subcutaneous wound infiltration has not been evaluated. This~     study aims at evaluating the efficacy of subcutaneous wound infiltration in total knee~     arthroplasty in 16 patients undergoing bilateral knee arthroplasty.~   "
201342|NCT00927212|"~     Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The~     purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for~     the treatment of Atopic dermatitis.~   "
201343|NCT00927199|"~     The purpose of this study is to assess the efficacy of high-oleic canola oil and a high-oleic~     canola/flaxseed oil blend as compared to a typical Western diet on plasma lipids, fatty acid~     profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic~     patients. Furthermore, the metabolism of dietary oleic acid and alpha-linolenic acid~     contained in high-oleic canola oil and flaxseed oil will be investigated.~   "
201344|NCT00927186|"~     The purpose of this study is to investigate how teriparatide or zoledronic acid affects the~     bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone~     biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12~     months of treatment all participants are eligible to participate in an additional 12-month~     open label extension.~   "
201345|NCT00927173|"~     The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS,~     (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in~     subjects with Major Depressive Disorder that have been previously unsuccessfully treated with~     antidepressant medications.~   "
201346|NCT00927160|"~     The purpose of this study is to determine if a new model of care, the Mobile Acute Care of~     the Elderly Unit is beneficial in improving patient outcomes for elderly patients admitted to~     the hospital.~   "
201393|NCT00926523|"~     We hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage~     migration inhibitory factor (MIF), that remodeling is in fact the reflection of a chronic~     inflammatory process, and that MIF may be a useful biomarker of the severity and progression~     of both ILD and PH.~   "
201678|NCT00922623|"~     This is a study to assess how safe and effective an investigational product, Belotero® is in~     people with all skin types with facial wrinkles, such as nasolabial folds. Nasolabial folds~     are wrinkles on the face that go from outside of the nostrils to the edges of the mouth.~   "
201347|NCT00927147|"~     The purpose of the study is to investigate efficacy and safety boron neutron capture therapy~     (BNCT) administered in combination with cetuximab in the treatment of head and neck cancer~     that has recurred locally following conventional cancer treatment (surgery and radiation~     therapy). Boron neutron capture therapy is a special form of radiation therapy, which is~     based on interaction between boron atoms taken up by the cancerous tissue and neutron~     irradiation. The boron atoms, located within cancer cells, may capture low-energy neutrons~     obtained from a nuclear accelerator, which results in splitting up (fission) of the boron~     atoms, and a high radiation effect within the tumor. Cetuximab is an antibody directed~     against certain proteins found on cancer cell surface (epidermal growth factor receptors).~     When administered immediately after BNCT, cetuximab may or may not improve treatment~     efficacy.~   "
201348|NCT00927134|"~     The aim of the study is to evaluate the side effects and risks after infusion of retroviral~     gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned~     (busulphan) children with chronic granulomatous disease (CGD). Also gene corrected and~     functional active granulocytes in the peripheral blood and the engraftment in the bone marrow~     of the patients will be monitored an documented.~   "
201349|NCT00927121|"~     There are many treatments for chronic tinnitus that have been claimed, with varying degrees~     of statistical reliability. None of those treatments can eradicate the tinnitus completely.~     Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there~     is still a need of new treatments that can reduce considerably the tinnitus symptoms and~     improve the QOL of subjects.~      Trial objectives:~        -  The aim of this trial is the improvement of the QOL (quality of live) by reducing the~          Tinnitus- Symptoms of the patient.~        -  To confirm the efficacy and safety of the coordinated reset technology.~      These objectives will be assessed:~        -  By subjective and objective measurements of the Tinnitus symptoms, loudness and~          annoyance.~   "
201350|NCT00927108|"~     To study the success of Oligodendrocyte progenitor cell culture project in Rajavithi Hospital~     to identify an unlimited clone human neuronal progenitor stem cells from the human brain in~     the Biomolecular Research Center. This study aims to produce the reproductive clone of~     neuronal development protocols and advance projects. Neuronal cells such as pyramidal cells,~     oligodendrocyte, and dopaminergic neuron differentiation protocol/projects for treatment of~     Alzheimer's disease, Multiple sclerosis, and Parkinson's disease respectively in next phase~     of clinical trials.~   "
201351|NCT00927095|"~     The purpose of this study is to compare a low dose oral contraceptive (OC) given continuously~     (every day for three months) with the same low dose oral contraceptive given in an~     interrupted regimen (one week of inactive placebo pills each month) and with continuous~     placebo (inactive placebo given every day for three months). The primary hypothesis is that~     continuous OC will be significantly more effective in reducing premenstrual symptoms compared~     with either the interrupted OC or continuous placebo.~   "
201352|NCT00927082|"~     This study is a long-term post-treatment follow-up to study WV19432, which evaluated the~     efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B~     (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to~     enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the~     target sample size is 100-500 individuals.~   "
201353|NCT00927069|"~     This study will provide data on additional therapeutic benefits in administering Adalimumab~     in patients with plaque psoriasis that showed an unsatisfactory response after at least 3~     months of treatment with etanercept.~   "
201354|NCT00927056|"~     Overall Objective: To evaluate pain and functional status of patients undergoing surgical~     correction for lumbar herniated disc, pre- and post-surgery, using subjective (VAS, Oswestry,~     PSQI, Patient Expectation), as well as, objective measures of physical activity (triaxial~     accelerometry).~      Design and Methods: Two groups of subjects will be examined; 1) patients diagnosed with~     lumbar herniated disc undergoing minimally invasive microdiscectomy (MD), and 2) patients~     diagnosed with lumbar herniated disc undergoing open microlumbar discectomy (OD).~      Subjects who agree to participate, will be assessed (assessments listed below) after the~     diagnosis and prior to surgery. The subject will then be assessed postop and they will~     continue with follow-up after surgery with a visit at 3 weeks postop. Both methods of~     discectomy will be discussed with the subject. Once the subject has consented to participate~     (and prior to surgery), subjects will be randomized with a 50/50 chance of being placed in~     the MD or OD groups. Subjects will be distributed into the MD group and the OD group using a~     block randomization method. The study will be single blinded. A longitudinal, within group,~     comparison will be made to assess the change in the measured parameters. Data involving the~     MD and OD groups will be accumulated in a cross-sectional fashion.~      Subjects will be recruited from the referrals to the practices of the Orthopedic and~     Neurosurgeon Spine Surgeons at the Health Sciences Centre. This encompasses the majority of~     new and currently managed cases in the Manitoba and Northwestern Ontario.~      Subjects will be between the ages of 18 and 90. Male and female subjects will be recruited~     into the study. All patients will clinically demonstrate unilateral lower extremity pain in~     greater proportion to low back pain symptoms if present. Imaging (CT) will document single~     level lumbar herniated nucleus pulposis. Exclusion criteria will be cauda equina syndrome,~     progressive neurologic deficit, bilateral lower extremity symptoms, low back pain more than~     leg pain, the existence of significant co-morbidity (e.g. cardiac condition, disease, etc.)~     of any form, and any other physical limitations (musculoskeletal injury). Subjects~     participating will be required to speak and read English.~   "
201355|NCT00927043|"~     This is an epidemiological, prospective, multicenter study designed to identify the~     pre-treatment clinical, molecular and genetic prognostic factors associated with progression~     free survival in patients naïve to renal cell carcinoma (RCC) treatment.~   "
201356|NCT00927030|"~     The purpose of this study is to determine if liquid supplemental melatonin is an effective~     treatment for children with autism who have sleep problems related to insomnia (difficulty~     falling asleep).~   "
201357|NCT00927017|"~     The hypothesis is that liquorice lowers plasma potassium. This study aims to elucidate the~     dose-response of this effect with two doses of liquorice (66 grams or 102 grams) per day for~     two weeks.~   "
201358|NCT00927004|"~     This study aims to better understand the way in which painful osteoarthritis affects~     different people and whether an anti-inflammatory medication such as Arcoxia (etoricoxib) can~     help to modify this pain. The study will use questionnaires and tests of pain sensitivity to~     identify arthritis sufferers with more widespread, nerve-type pain and then to investigate~     whether a daily dose of Arcoxia is more effective than a placebo pill in reducing these~     symptoms and improving functional movements. The study will also be comparing the same test~     results of a small group of subjects without knee pain.~   "
201359|NCT00926991|"~     This is a prospective, observational trial of 50 patients who have multiple, severe rib~     fractures following trauma. The investigators will follow their hospital stay for outcomes~     (infections, length of stay and medical care) as well as their early post-hospital course.~   "
201360|NCT00926978|"~     This research study is to compare the radiopharmacokinetics of I-124 to the~     radiopharmacokinetics of I-131 in patients who have well-differentiated thyroid cancer after~     recombinant human thyroid-stimulating hormone (rhTSH) injection. I-131 is routinely used for~     imaging and dosimetry for patients with well-differentiated thyroid cancer. In this study,~     I-124 is administered orally in capsular form, and the radiopharmacokinetics of I-124 is~     compared with I-131. I-124 is another isotope of iodine, which is cyclotron-produced. I-124~     has multiple advantages:~        -  Ideal Half-Life (4.2 days) for delayed imaging.~        -  High resolution tomographic imaging.~        -  Feasibility of quantitating lesion uptake.~        -  Potential of dosimetry for the planning of radioiodine therapy.~      Voluntary patients will have I-124 dosimetry performed in addition to the I-131 dosimetry,~     which is planned as part of routine clinical care. I-124 dosimetry is composed of four parts:~     (1) two extra doses of injections of rhTSH, (2) the administration of I-124, (3) PET imaging,~     and (4) drawing blood samples.~      Patients will receive two additional injections of rhTSH. This is similar to the procedure~     for I-131 dosimetry. Second, they will receive I-124. I-124 is similar to I-131 except I-124~     decays in a different way to emit a positron so that the PET scanner can be used for imaging.~     I-124 is given in the form of one or several capsules, which are taken by mouth. This is also~     similar to I-131. Third, PET/CT imaging is done for approximately 30 minutes to one hour on~     five consecutive days. Radiation from PET/CT scan is far less than what they receive from a~     diagnostic CT scan. For the fourth part, a technologist will draw about 5 cc from the forearm~     on each of the five consecutive days. This is also similar to I-131.~      Initially, all patients will be randomized to one of two study groups. The first group will~     have the I-131 dosimetry performed first followed by the I-124 dosimetry, and the second~     group will have the I-124 dosimetry performed first followed by the I-131 dosimetry.~      The risk of this study is considered very low, and the potential benefits to the patient are~     considered very high.~   "
201361|NCT00926965|"~     Previous researchers indicate that impaired cognitive flexibility was the primary factor~     distinguishing patients with from those without tardive dyskinesia (TD)1, and cognitive~     dysfunction correlates positively with the severity of TD2. Longitudinal data raised the~     possibility that the association between cognitive dysfunction and TD may reflect not organic~     vulnerability to but rather a state marker for this movement disorder as tardive dementia3.~     Atypical antipsychotic had been reported to alleviate the severity of TD4 and improved~     neurocognitive function separately5. But no researchers ever investigated the correlation of~     the two effects simultaneously. This randomized, single-blind and controlled study compared~     the effect of atypical antipsychotic on TD, neurocognitive function and associated factors~     for these changes.~   "
201362|NCT00926952|"~     Actinic keratoses on the face are often numerous and widespread. The application of~     Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic~     film on each lesion is difficult and takes time for subjects with many actinic keratoses. The~     waiting period of 3 hours between MAL cream application and red light exposure is also long~     for patients. The goal of this study is to evaluate the safety and efficacy of photodynamic~     therapy (PDT) with MAL with a shorter cream application time (90 minutes) and when MAL is~     applied on the entire face without the plastic film.~   "
201363|NCT00926939|"~     The purpose of the study is to evaluate a sustainable and broadly accessible treatment~     delivery model (Motiv8) for smoking cessation based on abstinence-reinforcement.~   "
201364|NCT00926926|"~     This study explores the effect of oxybutynin topical gel on gastric emptying~   "
201365|NCT00926913|"~     With the aging of the population, the prevalence of age-related macular degeneration (AMD)~     eye disease has resulted in a large number of people suffering from central vision loss. In~     fact, the most prevalent cause of blindness among veterans is AMD. Since the number of~     elderly veterans is expected to double in the next 10 years, loss of vision due to AMD is~     also expected to proportionally and considerably escalate. People with impaired vision have~     difficulty with daily activities, such as, reading, driving, and recognizing faces. The goal~     of the research project is to provide information on factors that contribute to visual~     impairment. This knowledge is necessary for the development of innovative approaches that~     will optimize the benefit of vision rehabilitation techniques, aimed at improving vision,~     thus allowing our veterans to maintain function and productivity. The findings from the~     proposed research will benefit our veterans and all aging people.~   "
201366|NCT00926900|"~     The aim of this project is to explore whether the extinction of cue-reactivity following a~     cue-exposure based intervention in volunteers with an alcohol dependence is facilitated by~     drugs that increase NMDA-receptor function.~      It is hypothesised that targeted treatment with D-Cycloserine prior to each extinction~     training session enhances the effects on cue-reactivity.~      Further, a significant correlation between the reduction of cue-reactivity and both reduced~     craving and relapse probability is expected.~   "
201367|NCT00926887|"~     The goal of the clinical study was to see if applying low level laser light therapy to the~     breasts during breast implant surgery could lessen pain experienced by 24 hours after the~     surgery.~   "
201368|NCT00926874|"~     A pilot, prospective, comparative study. To include both male and female patients who have~     presented an ischaemic stroke (full stroke or TIA) or an ACS, 5 to 30 days prior to~     inclusion.~      The proposed study aims to investigate and analyse the differences in functional and~     structural arterial properties between the patients who presented an ischaemic stroke and~     those who presented ACS. The hypothesis is that the patients in both groups will present~     differences partly in terms of their traditional cardiovascular risk factors, but also in~     terms of their arterial properties. All of the confounding factors studied (cardiovascular~     risk factors, treatments) will be taken into account in order to explain the differences in~     the arterial properties found between the two groups. Furthermore, the prevalence of signs~     and symptoms in the two populations will be studied.~   "
201369|NCT00926861|"~     Choroidal neovascularisation in age related macular degeneration is one of the major causes~     of legal blindness in the western world existing in two major occurences, the dry and the wet~     form.The etiology of age related macular degeneration is yet unknown. Genetic factors,~     oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as~     etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may~     transform to a wet form. From a prior study the investigators know that the posterior hyaloid~     is significantly more frequent attached in wet AMD. This study is conducted to examine~     whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.~   "
201370|NCT00926848|"~     The objective of the proposed study, using an experimental, two-group (n = 30 couples in each~     group) repeated measures design, will be to pilot test the effects of the PaTH Intervention~     versus a usual care group in improving the following outcomes: a) physical activity and~     healthy eating behaviors, b) functional capacity; c) quality of life (physical,~     psychological, and relational); and d) risk level for heart disease. The primary variables~     will be change in outcomes from baseline to 3 and 6 month time points in both the coronary~     artery bypass graft (CABG) patient and his/her partner.~   "
201371|NCT00926835|"~     The primary purpose of this study is to investigate the effectiveness of antidepressants on~     the treatments for non-psychotic major depressive disorder (MDD) in Korea. The study divides~     MDD patients into 3 level groups according to their past histories to treatments and compares~     the effectiveness of various treatment regimens at each level.~      The treatment level groups are: 1) patients who have never been treated with appropriate~     medications for their current depressive symptoms before, 2) who received an appropriate SSRI~     (Selective Serotonin Reuptake Inhibitor) once but did not respond to it, 3) who received two~     types of SSRI antidepressant treatments without much effects in reducing their depressive~     symptoms.~      The first level group will be treated with a single SSRI antidepressant treatment. The second~     and third level groups, who received SSRI treatment before, will be treated with alternative~     SSRI antidepressants (switching), combined multiple SSRI treatments (antidepressant~     combination), or SSRI treatments combined with mood stabilizer or anti-psychotics~     (augmentation). This study does not use placebos. Patients will visit 5 times for 6 weeks at~     each level for treatments. Patients will be evaluated for the severity of depressive~     symptoms, functional level, and side effects at each visit. Afterwards, the investigations~     will combine to monitor the patients depressive symptoms in every 3 months for the next 24~     months. 18 nationwide university hospitals will participate in this study. This multi-site,~     prospective, and naturalistic study for patients with depression in Korea is a main project~     of 'Clinical Research Center for Depression' funded by the Ministry for Health, Welfare, and~     Family Affairs (MIHWAF) in Korea for a highly-qualified research achievement.~   "
201372|NCT00926809|"~     This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing~     of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic~     lesions and is a multicenter, randomized, double blind, and placebo controlled trial.~   "
201373|NCT00926796|"~     The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is~     a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However,~     some gonorrhea is not cured with a single antibiotic. The study will look at how well~     treating gonorrhea with 2 antibiotics works. Participants will be assigned to 1 of 2~     treatment groups each receiving a combination of 2 antibiotics. Sites in the United States~     will recruit 500 male and female participants. Participants must be 15 to 60 years old, in~     good health and identified in participating sexually transmitted disease clinics as having~     uncomplicated cervical or urethral gonorrhea. Procedures include collection of current~     symptoms, medical and sexual history, sexual orientation, vital signs, height, weight,~     cervical/urethral cultures and clinical examinations. Volunteers will be involved for about~     17 days.~   "
201374|NCT00926783|"~     This study will be a multicenter, open, prospective, randomized trial. Patients with either~     paroxysmal or persistent atrial fibrillation will be considered for the study. (For US, only~     paroxysmal atrial fibrillation will be considered.) Eligible subjects will be randomized into~     one of two arms in the study: (1) targeted CFAE ablation or (2) generalized CFAE ablation.~     Both techniques will then be followed by PVAI (pulmonary vein antral isolation) as part of a~     hybrid ablation strategy. The nature of the ablation procedures does not allow physicians to~     be blinded to the randomization.~   "
201375|NCT00926770|"~     Preterm infants often need peripheral artery catheters for invasive blood pressure recording~     and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral~     oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling~     volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while~     changes of cerebral oxygenation are measured. The investigators hypothesise that slower~     sampling decrease changes in cerebral blood flow.~   "
201376|NCT00926757|"~     Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is~     common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous~     infected by HBV but negative for HBsAg have a the risk of HBV reactivation during~     chemotherapy, but prophylactic antiviral treatment is not a routine by current American~     Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might~     reduce the risk of HBV reactivation in such patients.~   "
201377|NCT00926744|"~     The purpose of the present study was to clarify the effects of increase in physical activity~     on incidence and surrogate marker of cardiovascular diseases. The working hypothesis of the~     present study was that the physical activity to satisfy the Japanese guideline of Ministry of~     Health, Labour and Welfare is effective for the primary prevention of the lifestyle-related~     disease.~   "
201378|NCT00926731|"~     A study to assess the safety and tolerability of AZD1152 in combination with low dose~     cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three~     patients to complete a 28 day cycle in the cohort, before the second three patients start~     treatment.~   "
201379|NCT00926718|"~     Eighty subjects will be recruited from those scheduled for surgery requiring general~     anesthesia at St Vincent's Hospital. Subjects must have American Society of Anesthesiologists~     (ASA) status of 1 or 2 (be fairly healthy), a BMI between 18-35 (reasonably healthy weight),~     and be between the ages of 18 and 75. They will not be eligible if they take certain~     medications or are expected to have a difficult intubation.~      Subjects will be randomized (assigned by chance) to one of four rocuronium doses of 0, 0.2,~     0.4, or 0.6 mg kg-1. All are acceptable clinical doses for performing a laryngoscopy. In the~     operating room, routine monitors will be applied, including a Bispectral Index (BIS) sensor~     and an M-Entropy sensor. Subjects will receive 0.025 mg kg-1 midazolam (a standard pre-op~     dose) and will be put to sleep. Once asleep, the subject will receive a rocuronium dose,~     followed by laryngoscopy three minutes later. The anesthesiologist performing the~     laryngoscopy will not know what dose of rocuronium the subject received. CVI, entropy, amount~     of muscle relaxation, and vital signs will be monitored and recorded throughout the~     procedure.~      Subjects will receive propofol and remifentanil infusions during the case. These are commonly~     used medications for anesthesia. The subjects will also be randomized to two additional~     groups. One group will receive a remifentanil infusion of 2ng ml-1 and the other group will~     receive a 8ng ml-1 remifentanil infusion. Both doses are acceptable and often used during~     standard clinical care. The propofol infusion will be adjusted to keep the BIS number between~     45-60. The anesthesiologist will not be able to see the CVI value. The times of certain~     intraoperative events, such as intubation and incision, will be recorded. All subjects will~     receive a morphine bolus (0.10-0.15 mg/kg) towards the end to reduce post-operative pain, as~     per standard clinical care. As the subject wakes up, time to eye opening and orientation will~     be recorded. The subject will rate their pain on a numerical pain scale and the quality of~     emergence will be assessed.~      Upon arrival in the post anesthesia care unit (PACU), subjects will be asked to rate their~     pain again using the same pain scale. The pain score will be evaluated every 10 minutes for~     half an hour, then every hour until they are discharged from PACU.~   "
201380|NCT00926705|"~     The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for~     pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for~     intraoperative and postoperative analgesia.~   "
201381|NCT00926692|"~     The aim of this research is to define the human equivalent of mouse B1 cells.~   "
201382|NCT00926666|"~     Studies have suggested a link with effective pain relief and reduced illness and death in~     high risk patients. Ultrasound guided nerve blocks have been associated with an increased~     success rate and allow visualization of all the anatomical structures and the distribution of~     the local anesthetic on injection. The hospital mortality for patients admitted to hospital~     from home in the UK in 2006 with a fractured hip is 14.3% (Bottle and Aylin 947-51).~      The aim of this clinical trial is to determine the effective dose of local anesthetic to~     provide pain relief to patients with a broken hip using ultrasound to guide needle insertion.~     The hospital mortality for patients admitted to hospital from home in the UK in 2006 with a~     fractured hip was 14.3%. Patients for emergency surgical fixation or replacement of broken~     hip will be recruited prior to surgical fixation. All patients recruited to this study will~     receive standard anesthesia and surgical fixation of their broken hip.~      The trial can be divided into two sequential parts; the results of part A will be an amount~     of local anesthetic which will relieve pain of a broken hip in 95% of all patients. Part B~     will determine the duration of pain relief provided by the amount of local anaesthetic from~     part A and blood levels of local anesthetic.~      In parts A and B a standard pain relieving nerve block to numb the nerves supplying the hip~     joint will be administered using ultrasound to guide the injection of local anesthetic. The~     patient will then be observed for 30 minutes during which time the feeling in the upper leg~     and pain scores will be recorded. Patients with ineffective nerve blocks will be given~     immediate pain relief and withdrawn from further participation in the study.~      In part A the amount of local anesthetic for the next patient will be increased or decreased~     if the nerve block is ineffective or effective respectively.~      In part B the dose will be the same (calculated from the results of part A). In order to~     determine the duration of pain relief pain scores will be recorded hourly for up to 24 hours.~     Blood samples will be taken before the pain relieving nerve block and at 5, 10, 20, 30 and 60~     minutes afterwards.~   "
201383|NCT00926653|"~     This study will examine differences in activity of the anterior cingulate cortex, a brain~     area involved in emotion and cognitive regulation, between older adults with and without~     depression.~   "
201384|NCT00926640|"~     BACKGROUND:~        -  The histone deacetylase (HDAC) inhibitors are a novel class of anticancer agent. These~          agents lead to the increased acetylation of both histone and non-histone proteins, which~          leads to rapid cell death in many tumor models. It is thought that the cell death~          observed with this class of agents may be mediated, in part, through the selective~          acetylation of histone proteins resulting in increased expression of specific genes.~        -  For solid tumors in general, cell death in preclinical models has not translated to~          activity in patients. For this reason, studies increasingly have combined chemotherapy~          with HDAC inhibitors to achieve additive and potentially synergistic effects on cancer~          cells.~        -  This protocol will study a continuous infusion of the HDAC inhibitor belinostat in~          combination with cisplatin and etoposide for patients with advanced cancer.~      OBJECTIVES:~        -  To determine a safe and tolerable phase 2 dose for the combination of belinostat with~          cisplatin and etoposide.~        -  Evaluate molecular markers of HDAC inhibition.~      ELIGIBILITY:~        -  The protocol will be open to all patients with recurrent or advanced cancer (small-cell~          lung cancer and other advanced cancers) for whom standard therapy offers no curative~          potential.~        -  Age greater than or equal to 18 years~        -  ECOG Performance Status 0-2~      DESIGN:~        -  The study will begin with belinostat 400 mg/m (2)/24h administered by continuous IV~          infusion on days 1 and 2, cisplatin at 80 mg/m (2) IV on day 2, and etoposide at 100~          mg/m (2) IV daily times 3 on days 2 - 4. Dose escalation of belinostat will follow~          according to traditional 3 patient cohorts.~        -  Treatment schedule and dose escalation schemata.~   "
201385|NCT00926627|"~     Progressive pulmonary sarcoidosis occurs in up to twenty percent of patients who require~     persistent treatment, but available treatment options have shown considerable long-term~     toxicity and uncertain or unproven efficacy. In these patients, pulmonary fibrosis and~     pulmonary hypertension are common complications which have major prognostic impact.~     Endothelin-1 (ET-1) has been demonstrated to play a key role in pulmonary fibrosis and~     pulmonary hypertension, and a potential role in pulmonary sarcoidosis. ET-1 is a potent~     vasoconstrictor and can promote fibrosis, cell proliferation, and remodeling, and is~     pro-inflammatory. Preliminary data have shown the therapeutic potential of the endothelin~     receptor antagonist (ERA) bosentan in sarcoidosis associated pulmonary hypertension.~      In this light, the therapeutic potential of bosentan as an add-on treatment in progressive~     pulmonary sarcoidosis needs to be evaluated.~   "
201386|NCT00926614|"~     The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a~     lipid lowering agent (statin) improves sustained virologic response rates in patients who~     have previously not responded or relapsed on standard pegylated interferon and ribavirin~     therapy.~   "
201387|NCT00926601|"~     Several case report showed that the co-infection of Mycoplasma pneumoniae in patients with~     pulmonary tuberculosis. The aim of this study is to elucidate the prevalence and its clinical~     significance of co-infection of Mycoplasma pneumonia in patients with newly diagnosed~     pulmonary tuberculosis.~   "
201388|NCT00926588|"~     Pain is the most common physical symptom in primary care, accounting for an enormous burden~     in terms of patient suffering, quality of life, work and social disability, and health care~     and societal costs. Pain is particularly prevalent among veterans. Four major barriers to~     optimal care include underdetection of pain, inadequate initial treatment, failure to monitor~     adherence and symptom response, and failure to adjust treatment in patients not responding or~     intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize~     Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary~     care.~   "
201389|NCT00926575|"~     Use of an oral topically-active glucocorticoid with limited side effects will control the~     gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.~   "
201390|NCT00926562|"~     The investigators intend to find out which contrast agent has less kidney toxicity in renal~     impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).~   "
201391|NCT00926549|"~     The purpose of this study is to analyze macular retinal thickness and macular volume using~     the spectral domain - optical coherence tomography (SD-OCT) in normal eyes and in eyes with~     various ocular diseases.~   "
201392|NCT00926536|"~     Patients will be enrolled based on presence of HCC and eligibility for TACE. They will be~     randomized to one of two arms for imaging navigation to the optimal catheter location for~     chemotherapy injection to treat the first (possibly sole) tumor target. The two arms will be:~     TACE using C-arm CT supplemented by DSA or DSA only (only DSA images will be used for~     navigation and tumor vessel tracking). Navigation to subsequent treatment targets in all~     patients will be done with fluoroscopy, CACT, and DSA, as is standard of care at Stanford~     University Medical Center, and is not part of the study. Vascular complexity, which affects~     navigation difficulty and thus the need for imaging, will be assessed separately for use in~     data analysis by two radiologists on a four-point scale.~   "
201409|NCT00926315|"~     The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor~     cell proliferation and influence gene expression profile of breast cancer samples from~     post-menopausal patients.~   "
201394|NCT00926510|"~     To investigate whether young children with isolated expressive language delay benefit from~     early intervention with a simple language toolkit and brief instructions provided to their~     caregivers.~      We hypothesize that children whose families are provided the language toolkit will develop~     more words over the subsequent 3 months.~   "
201395|NCT00926497|"~     Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic~     therapy is crucial for treatment success.~      Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf~     antibiotic therapy in suspected neonatal early-onset sepsis.~   "
201396|NCT00926484|"~     GC Tooth Mousse, a complex containing amorphous calcium phosphate (ACP) and casein~     phosphopeptide (CPP), is recommended in dentin hypersensitivity reduction due to its ability~     to block opened dentinal tubules. It acts synergistically with fluorine in slowing caries~     progression. Whether CPP-ACP can act synergistically with fluorine in the dentin~     hypersensitivity treatment is unknown. The aim of this study was to assess the effect of~     CPP-ACP combined with fluoride varnish in cervical dentin hypersensitivity treatment.~   "
201397|NCT00926471|"~     This study will develop and test a treatment aimed at reducing anxiety in social situations~     for children and adolescents with autism spectrum disorders.~   "
201398|NCT00926458|"~     The aim of the study is to evaluate and compare the value of 5 different non-invasive~     diagnostic methods in patients with chest pain suspected for coronary artery disease. The~     investigators intend to include 200 patients over a 3 year period in the study. The~     participants will be recruited from patients referred to coronary angiography at the~     institution. Before the angiography the participants will (1) test the effect of sublingual~     Nitroglycerin, (2) give their medical history so mathematical models can estimate the~     probability of the presence of coronary artery disease, (3) take part in a contrast stress~     echocardiography and (4) a 2D-strain stress echocardiography and a myocardial scintigraphy.~     Stenosis found at the angiography will be the gold standard.~   "
201399|NCT00926445|"~     Preterm and critically ill neonates experience many painful manipulations. The aim of the~     study is to evaluate the influence of these experiences and maternal deprivation on later~     pain behavior. Using Scoring systems, Prechtl general movements, skin conductance, testing~     flexor reflex levels with von Frey filaments and measuring salivary cortisol levels the~     investigators compare pain behavior of preterm (birth weight (BW) < 1500 grams), term~     neonates with need of ventilation (> 48 hours) with healthy neonates at the time of their~     first vaccination at the age of 3-4 months. The investigators are also testing flexor~     reflexes and skin conductance and general movements in regular intervals during the initial~     hospital stay. The investigators hypothesize that pain behavior is different at the age of~     3-4 months in children with many early painful experiences.~   "
201400|NCT00926432|"~     Description of the geometrical configuration of the skeleton with regard to gravity line by~     patients suffering from spinal disorders that may induce postural troubles~   "
201401|NCT00926419|"~     This study aims to assess immunogenicity and safety of nd influence of the delivery system~     (needle-free injector or syringe with needle) of fractional doses (dose sparing) of two~     vaccines (Varicella and Hepatitis A vaccines) in children aged 13 to 30 months.~   "
201402|NCT00926406|"~     One thousand patients with LHD who have no history of exposure to lead will be observed for~     18 months. Blood lead level(BLL), biochemical data, hemoglobin, albumin, Cr, high sensitivity~     C-reactive protein (HsCRP), and blood cell counts are assessed at baseline. The morbidity and~     mortality are recorded in detail. Then, one hundred subjects with high BLL (>20μg/dl) will be~     randomly assigned to the study and control groups. For 3-6 months, the 50 patients in the~     study group will receive lead-chelation therapy with calcium disodium EDTA weekly until the~     BLB falls below BLL< 5 μg/dl, and the 50 control group patients receive weekly placebo for 12~     weeks. During the ensuing 18 months, the BLL, biochemical data will be regularly followed up~     every 3 months. BLL is measured every 6 months. If BLL of the study group patients increase~     >10 μg/dl, the chelation therapy will be performed again until their BLL is <5 μg/dl. The~     primary end point is morbidity or mortality during the observation and follow-up period. A~     secondary end point is the change in hemoglobin, albumin, Cr and Hs CRP during the follow up~     period.~   "
201403|NCT00926393|"~     The purpose of the study is to compare the sedation profile one hour after dose~     administration between Seroquel IR and Seroquel XR.~   "
201404|NCT00926380|"~     The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis~     therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will~     increase bone mineral density more than either one alone in postmenopausal osteoporotic~     women.~   "
201405|NCT00926367|"~     This is a single-blind (blinded expert grader), randomized, half-face study being conducted~     at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products,~     antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral~     side of the face will remain non-treated to serve as a control. Approximately 25-30 male and~     female healthy subjects will be randomly assigned to each product~   "
201406|NCT00926354|"~     Chemotherapy Induced Thrombocytopenia is a common side-effect of bone marrow suppression as a~     result of a chemotherapy treatment. AS101 is a tellurium based small compound with~     immunomodulating characteristics which attributed to the direct inhibition of the~     anti-inflammatory cytokine IL-10. AS101 was previously shown to induce a significant~     reduction in thrombocytopenia that accompany cancer therapy with no major toxicity . This~     phase II randomized open study will evaluate the efficacy of AS101 for the treatment of~     chemotherapy induced thrombocytopenia in patients with various solid tumors.~   "
201407|NCT00926341|"~     Metabolic syndrome, labeled as the world's latest epidemic, is the force behind the global~     epidemic of Type 2 Diabetes Mellitus and Cardio Vascular Diseases. This emerging epidemic is~     an important public health problem for South Asians in their homeland and worldwide.~      Pharmacological therapy is a critical step in the management of patients with metabolic~     syndrome. In general, treatment for metabolic syndrome, that targets all or most of the~     components of metabolic syndrome is either deficient or non-existent. The study presented~     here is the pioneering work in the management of metabolic syndrome, the emerging global~     epidemic.~   "
201408|NCT00926328|"~     The objective of this study is to evaluate the performance of two toothpastes in controlling~     established gingivitis and dental plaque in adults.~   "
201411|NCT00926289|"~     The primary objective of this trial is to demonstrate that the fixed-dose combination of~     T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood~     Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3~     hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).~   "
201412|NCT00926276|"~     The purpose of this study is to evaluate the efficacy of fundoplication in premature infants~     with GERD and BPD.~   "
201413|NCT00926263|"~     This study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its~     effect on QT interval prolongation.~   "
201414|NCT00926250|"~     Sarcopenia, the age-associated loss of skeletal muscle mass and strength, is a frequent~     precursor to functional impairment, disability, falls, and loss of independence in the~     elderly. The prevalence of sarcopenia is high, with ≥ 45% of the U.S. population aged 60~     years or older sarcopenic. Some possible causative factors include a decline in muscle~     protein synthesis, inactivity, hormonal changes, pro-inflammatory conditions, and reactive~     oxygen species within the muscle mitochondria, which may all be exacerbated by inadequate~     nutritional intake. Since dietary protein is targeted to muscle and muscle mass represents~     the largest tissue in the body, protein nutrition plays a significant role in muscle~     metabolism.~      SPECIFIC AIMS The specific aim of this proposed study is to determine the effect of PS-IPC~     supplementation on muscle mass, muscle strength, muscle quality, and inflammatory / immune~     markers in healthy older adults. Subjects scoring 4 - 10 on the Short-Physical Performance~     Battery and aged 60-85 years will consume PS-IPC supplements or placebo three times daily for~     12 weeks.~      HYPOTHESES~        1. Subjects consuming PS-IPC will have a greater increase in muscle mass and muscle~          strength compared to a control group consuming a placebo supplement.~        2. Subjects consuming PS-IPC will demonstrate a greater increase in the fractional rate of~          muscle protein synthesis compared with a placebo control group.~        3. Subjects receiving PS-IPC will have a reduction in plasma concentrations of various~          inflammatory markers of immune function, compared to subjects consuming the placebo.~   "
201415|NCT00926237|"~     One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in~     the ear) ranging from mild to severe impairment. To date, there are no effective therapies~     available that have been shown to decrease tinnitus loudness. The purpose of this study is to~     develop a new treatment option for tinnitus using a technique called Repetitive Transcranial~     Magnetic Stimulation (rTMS), which will hopefully prove to be an effective means of~     alleviating or reducing the symptoms of tinnitus.~   "
201416|NCT00926224|"~     The main objective of the study is to evaluate the diagnostic performance of the XL probe for~     estimating degree of liver fibrosis/cirrhosis in obese patients > 28 kg/m² with various liver~     diseases in patients with chronic liver disease scheduled for a liver biopsy.~   "
201417|NCT00926211|"~     The objective of this clinical study is to investigate and compare the safety and efficacy of~     the Restoration Robotics Computer-Assisted Harvesting System to the manual hair follicle~     harvesting method following a nine-month period of post-procedural evaluation.~   "
201418|NCT00926198|"~     Acute pharyngotonsillitis is one of the most common infections encountered by pediatricians.~     Most children with acute pharyngotonsillitis have symptoms that can be attributed to viral~     infection. However 30-40% of cases is of bacterial etiology.~      The purpose of this study is to examine frequency, age distribution, clinical picture and~     pathogen distribution in acute pharyngotonsillitis in children in a large urban setting.~   "
201419|NCT00926185|"~     The purpose of this study is to evaluate the efficacy of three different concentrations~     (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of~     dry eye.~   "
201420|NCT00926172|"~     The Chinese Cerebral Aneurysms Survey is a continuing prospective study among middle-aged and~     older individuals (35 - 75 years) that aims to determine the prevalence of cerebral~     intracranial aneurysms in the general population with MRA at 3.0 Tesla (T).~   "
201421|NCT00926159|"~     Prophylactic implant of an ICD (implantable cardioverter defibrillator) for prevention of~     sudden cardiac death from a life-threatening heart rhythm abnormality is a standard~     recommendation for patients with ejection fractions (EFs) of 35% or less. The main purpose of~     the trial is to determine why patients who are receiving care at a community-based cardiology~     program and are known to have a low ejection fraction (EF) measurement of 35% or less per~     echocardiogram and/or cardiac nuclear scan testing are not being approached for ICD~     (implantable cardioverter defibrillator) implant. Additionally, other secondary purposes of~     the trial are: 1) to determine if these patients are or are not receiving recommendation from~     their provider to undergo prophylactic ICD implant 2) identify the reasons providers are not~     recommending ICD implant for their patients with reduced EFs 3) determine reasons patients~     recommended for ICD implant by their provider elect not to have the implant.~   "
201422|NCT00926146|"~     In this study, researchers from UCLA and Friends Community Center will work together in~     designing a program to assist young homeless stimulant-using gay and bisexual homeless men to~     complete the hepatitis vaccine and in reducing drug and sexual activity. Using nurse case~     management strategies, found successful with homeless adults as well as contingency~     management strategies, found successful with gay and bisexual homeless adults by the~     community partners, the investigators will evaluate the effectiveness of a program that~     combines both strategies. As stimulant use threatens to increase homeless persons' risk of~     exposure to hepatitis A and B viruses, particularly among young users who may not yet be~     HBV-infected, this research is targeted to engage this group in treatment, until they are~     suitably protected from HBV, and hopefully reduce risk for HCV and HIV as well.~   "
201423|NCT00926133|"~     The present study was designed to determine the prevalence of previously unknown impaired~     glucose tolerance and type 2 diabetes in patients with acute ST-elevation myocardial~     infarction subjected to acute PCI. Secondary, a possible association between inflammation,~     haemostasis and abnormal glucose regulation was studied.~   "
201424|NCT00926120|"~     The purpose of this study is to determine if administering Mogroside Sweetener PureLo (the~     study substance) for 14 days will lower the hepatitis C viral load and liver function alanine~     aminotransferase (ALT) levels.~   "
201425|NCT00926107|"~     The primary objective of this study is to determine the efficacy of Temsirolimus in patients~     with ovarian cancer with CA125 only relapse after first-line platinum-based chemotherapy.~   "
201426|NCT00926094|"~     Idiopathic Adhesive Capsulitis, Frozen Shoulder is a condition in which there is a limitation~     and significant pain at the shoulder and it is increases with shoulder movements. The causes~     are not clear. The prevalence of this condition is four times higher in diabetic patient~     compare to the general population.~      The relation between frozen shoulder and impaired glucose tolerance remain unclear.~      Our hypothesis is that patients with no diabetes and that suffer from frozen shoulder have a~     higher prevalence of impaired glucose tolerance than the general population age matched.~   "
201427|NCT00926081|"~     The aim of the investigators' study is to analyze the value of supervised exercise training~     combined with medical therapy versus best medical treatment only with respect to quality of~     life. Furthermore, the investigators aim to evaluate the effect of supervised exercise~     training on microcirculation, peripheral endothelial progenitor cells as well as on future~     major cardiovascular adverse events.~   "
201428|NCT00926068|"~     A prospective, double blind, randomized, placebo controlled, outpatient, parallel group~     comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied~     topically once daily for up to 14 weeks in at least 196 subjects diagnosed with Diabetes~     Mellitus and having a single target non-healing Plantar Neuropathic Diabetic Foot Ulcer.~   "
201429|NCT00926055|"~     18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for~     identifying and quantifying vascular inflammation within atherosclerotic plaques. Therefore,~     in this study the investigators intend to compare the effect of ezetimibe monotherapy or~     ezetimibe plus statin combination therapy on the atherosclerosis regression using FDG-PET.~   "
201430|NCT00926042|"~     Registry program for volunteers who are willing to serve as control subjects in future~     research studies.~   "
201431|NCT00926029|"~     Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival~     inflammation.~   "
201432|NCT00926016|"~     The purpose of this study is to determine if rosiglitazone, a medicine used to treat~     diabetes, improves response to anti-viral treatment.~   "
201433|NCT00926003|"~     Research Topic: Over 110,000 HIV Ugandan children are at risk for neurocognitive disorders~     due to the progressive encephalopathy of CNS HIV infection. Even if clinically stable, these~     children can have motor, attention, memory, visual-spatial processing, and other executive~     function impairment. One-hundred and fifty school-age children with HIV in Kayunga District,~     Uganda, will serve as our participants. Fifty of these children will be randomly selected to~     receive 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT)~     program called Captain's Log, marketed mostly for American children with attention or~     learning problems. A locked version of Captain's Log which does not direct the child's~     training in a progressive manner will be administered to a second active control group;~     while a third group will be a passive control group not receiving any computer training~     intervention. Study Aim 1: To compare the neuropsychological benefit of 24 training sessions~     of Captain's Log CCRT to the active and passive control groups over a 8-week period, and at~     3-month follow-up. Study Aim 2: To compare the psychiatric benefit of 24 training sessions of~     Captain's Log CCRT to the active and passive control groups over an 8-week period, and at~     3-month follow-up. Study Aim 3: To evaluate how HIV subtype, ART treatment status, and the~     corresponding clinical stability of the child modifies CCRT neuropsychological performance~     gains and psychiatric symptom reduction. Outcome Assessments: The Kaufman Assessment Battery~     for Children, 2nd ed. (KABC-2), Tests of Variables of Attention (TOVA) visual and auditory~     tests, CogState computerized neuropsychological screening test, Bruininks-Oseretsky Test of~     Motor Proficiency (BOT-2), and Achenbach Child Behavior Checklist (CBCL) will be administered~     before and after the 8-week training period and at 3-month follow-up. We have previously used~     all these assessments with Ugandan children with HIV to effectively evaluate~     neuropsychological and psychiatric problems. Captain's Log has an internal evaluator feature~     which will help us monitor the specific training tasks to which the children best respond.~     Based on our prior research with Kayunga children with HIV, we anticipate that about 40% of~     our sample will be on ART at study enrollment, and about 20% will be Subtype D while 60% will~     be subtype A. We also observed that children with HIV Subtype A are at greater risk for~     neurocognitive deficits. Analyses: We will compare neuropsychological and psychiatric gains~     over the 8-week training period and at 3-mo follow-up for our three study groups,~     anticipating that they will be significantly greater for the CCRT intervention children~     (Study Aims 1 & 2). These neuropsychological gains will be associated with improved school~     performance over the long-term. Intervention children on ART will have greater gains than~     those not on ART, and HIV subtype D children will have lower viral loads and higher~     lymphocyte activation levels, resulting in greater gains from CCRT (Study Aim 3). Conclusion:~     CCRT will prove effective and sustainable in potentiating the neurocognitive benefit of ART~     in HIV children. It will prove viable for assessing and treating children in resource-poor~     settings.~   "
201434|NCT00925990|"~     The study is intended to determine whether CTS-1027 either alone or in combination with~     ribavirin is safe and effective in Hepatitis C patients who have not previously been treated~     with interferon.~   "
201435|NCT00925977|"~     A randomized, crossover, open study in order to compare treatment satisfaction with insulin~     Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children~     and adolescents with type 1 diabetes.~      The study will include two consecutive periods: 2 weeks run in period and 24 weeks~     intervention period, divided into two separate treatment periods of 12 weeks. According to~     randomization, each patient will be treated consecutively with both treatment arms: 12 weeks~     with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than~     12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction~     Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.~   "
201436|NCT00925964|"~     To investigate whether the presence of a Systolic pressure index (<0.9 or> 1.4) is a marker~     of risk of cardiovascular events after peri-operative high-risk surgery outside the cardiac~     and vascular surgery.~   "
201437|NCT00925951|"~     The hypothesis of this study is that the improvement of Numeric Rating Scale (NRS) for Pain~     at the end of the study will be greater in the Wet Cupping Treatment group than in the~     Waiting Control group.~   "
201438|NCT00925938|"~     A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to~     assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol~     Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office~     hysteroscopy procedure. Each subject will be randomized to receive one vaginal insert. The~     study drug will be administered vaginally by a member of the clinical research team (Part I)~     or insert herself (Part II) 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~     The internal os of the cervix will be measured at baseline, just prior to the hysteroscopy~     and at the follow up visit. The primary outcome measure is change in diameter of the internal~     cervical os from baseline (pre-treatment) to just prior to the hysteroscopy procedure~     (post-treatment). The hypothesis is that treatment with the MVPI will soften and dilate the~     cervix better than placebo.~   "
201477|NCT00925431|"~     Research has shown that weight problems are very common in fibromyalgia. Research also~     suggests that overweight and obesity may contribute to worsening of fibromyalgia symptoms and~     biochemical vulnerability associated with fibromyalgia. Effective weight management may be~     important in not only improving general health but also better management of fibromyalgia~     symptoms. Research has indicated that nutrition and coping education is important aspects of~     successful weight management. In this study, the investigators are evaluating the effect of~     nutrition and coping education on weight and symptom management of fibromyalgia among~     overweight and obese patients.~   "
201439|NCT00925925|"~     Low birth weight (LBW) status (< 10% for gestational age at birth) is associated with~     increased risk for diseases such as type II diabetes mellitus, hypertension, chronic~     obstructive pulmonary disease and coronary artery disease in adults, and represents one~     example of the fetal onset of adult disease hypothesis. Recent data strongly associates LBW~     status with impaired innate and adaptive immunity leading to increased risk for severe~     infections during adolescence or early adulthood. Animal studies suggest that the ratio of~     certain B lymphocyte subpopulations, the B1a and B1b cells, determines whether deficits in~     immunity occur.~      This study will determine the ratio of B1b to B1a lymphocyte subpopulations in the cord blood~     of infants born LBW in the late preterm to term gestations (> 34 weeks at birth) and compare~     those ratios with those of normal birth weight (NBW) controls in a nested case control study~     design.~      Furthermore, animal studies suggest that the expression patterns of CD5 and CD19 proteins~     determines the cellular phenotype of the B lymphocyte, that of a B1a or a B1b cell, and that~     the regulatory regions controlling their expression are epigenetically vulnerable. The~     investigators will therefore isolate DNA and RNA from both B lymphocyte subpopulations and~     determine whether epigenetic changes to the regulatory regions of the genes coding for CD5~     and CD19 protein expression occur in LBW lymphocyte subpopulations as compared to the~     lymphocytes from NBW infants.~      This proposal will be the first human study to examine epigenetic determination of a~     maladaptive phenotype following LBW status at birth in a specific cell type leading to a~     specific impairment of innate and adaptive immunity.~   "
201440|NCT00925912|"~     Hemorrhoidectomy can be carried out under several modes of anesthesia. In western country~     hemorrhoidectomy usually be performed under general anesthesia, however there may be the~     complications resulted from general anesthesia together with associated diseases in advanced~     age, caudal or spinal anesthesia has been used as an alternative to general anesthesia (GA)~     for hemorrhoid surgery but they all require a trained anesthetist and have numerous known~     complications. Since, anesthesiologists are not always available then local anesthesia is an~     alternative mode of anesthesia that surgeon can safely carry out by their own. Local~     anesthetic produce a loss of sensation and muscle paralysis in a circumscribed area of body~     by localized effect on peripheral nerve endings. The local anesthesia is able to provide~     fully relaxation of the anal canal which is an ideal setting for various anal surgical~     procedures. The results of hemorrhoid surgery under this mode of anesthesia have been~     demonstrated in many publications. Local anesthesia is a safe and effective technique while~     fewer risks and complications compared with general or spinal anesthesia. In Thailand both~     spinal anesthesia and local perianal block have routinely been used for various kinds of~     anorectal surgery. However, so far there has no any trial conducting to compare between these~     two techniques.~   "
201441|NCT00925899|"~     BACKGROUND:~      Patients with advanced cancer often suffer from fatigue and other symptoms and problems such~     as insomnia, appetite loss and pain. Problems that may have great consequences for their~     quality of life. Several studies suggest that a supplement of the hormone melatonin (MLT) may~     have a beneficial effect on these symptoms/problems. This needs further investigation.~      AIM:~      To investigate if a supplement of melatonin have an effect on a) fatigue (the primary outcome~     of the trial), b) the symptoms insomnia, appetite loss, depression and pain, and c) overall~     quality of life.~      METHODS AND PATIENTS:~      The trial takes place in the Department of Palliative Medicine, Bispebjerg Hospital, and 50~     patients will participate. The participants have to be 18 years or above, have advanced~     cancer, and suffer from quite a bit or very much fatigue.~      The study consists of two parts. In part I it is investigated if melatonin has a better~     effect than placebo on the outcomes mentioned above. This part is a consecutive, prospective,~     double blinded, randomized (MLT vs. placebo), cross-over study where the patients serve as~     their own control. In part II the effect of melatonin over time is investigated. Part II is a~     consecutive, prospective, open-label study.~      The outcomes are assessed with weekly questionnaires (MFI-20 and EORTC QLQ-C15PAL) and a few~     daily diary questions.~      Melatonin has been used in several studies, and the general conclusion is that it is a safe~     substance with few adverse drug reactions.~      PERSPECTIVES:~      If melatonin has the potential to alleviate fatigue and other symptoms in patients with~     advanced cancer and enhance the quality of life of these patients, this will be of benefit to~     many future patients. Trials such as this are important both nationally and internationally~     to develop an evidence-based palliative medicine.~   "
201442|NCT00925886|"~     The purpose of this study is to evaluate neutralization of keratometric astigmatism in~     patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the~     implantation of a toric intraocular lens.~   "
201443|NCT00925873|"~     In this study, patients were randomly assigned to either receive fludarabine or not (20~     mg/m2/d) in addition to induction chemotherapy, consolidation chemotherapy and the 3~     subsequent re-induction courses during maintenance.~   "
201444|NCT00925860|"~     The study is aimed to assess the possible benefit of non-positive pressure mechanical support~     in front of conventional ventilation in patients admitted to the intensive care unit (ICU)~     because of pure hypoxemic respiratory failure.~   "
201445|NCT00925847|"~     The purpose of the study is to determine whether lithium is safe and effective in the~     treatment of ALS~   "
201446|NCT00925834|"~     The aim of this randomized controlled pilot study was to answer the following questions:~        1. Is it possible to affect the diameter of coronary arteries through a placebo injection,~          which is administered intracoronarily together with a standardized verbal suggestion of~          coronary vasodilation?~        2. Is it possible to affect the diameter of coronary arteries through a pharmacologically~          underdosed nitroglycerine injection, which is administered intracoronarily together with~          a standardized verbal suggestion of coronary vasodilation?~   "
201447|NCT00925821|"~     Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment~     are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is~     permitted. After enrollment, patients are to receive four cycles of RAD induction treatment:~     a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a~     minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide,~     etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan~     chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such~     as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype)~     were present at diagnosis, patients will be allocated to a consolidative allogeneic~     transplant following dose-reduced conditioning. If no appropriate donor is available, the~     patient does not consent or lacks of high-risk features a second autograft following~     high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance~     (one year) following hematopoietic reconstitution.~   "
201548|NCT00924482|"~     1. Compare measurements of cardiac output derived from electrical measurements from~          electrodes on an endotracheal tube (ECOM or Endotracheal Cardiac Output Monitor) to~          those made from a pulmonary artery thermodilution catheter.~        2. Establish the safety and efficacy of the ECOM system.~   "
201448|NCT00925808|"~     This is a prospective study with the following objectives:~      Primary Objective:~        1. To estimate the prevalence of unsuspected VTE in oncology patients on routine staging CT~          scans of the thorax, abdomen and pelvis.~           Secondary Objectives:~        2. To identify symptoms commonly associated with VTE that are present in cancer patients~          undergoing routine staging CT scans with findings of unsuspected VTE.~        3. To identify the risk factors and demographic characteristics in outpatient cancer~          patients associated with the development of unsuspected VTE.~        4. To determine the incidence of recurrence of new VTE in patients with unsuspected VTE at~          3 and 6 months of follow-up.~   "
201449|NCT00925795|"~     HIV infection is associated with systemic inflammation that is involved in pathogenesis of~     atherosclerosis. Treatment of HIV infection may cause lipid profile disturbance and~     consequently, atherosclerosis progression. In general, extra virgin olive oil (EVOO) has~     beneficial effect on atherosclerosis markers. Our goals are to examine the effect of EVOO on~     atherosclerosis markers in HIV-treated patients. A controlled randomized cross-over study~     will be performed on 40 participants. They will consume EVOO and ROO (refined olive oil)~     during two 20 days intervention periods, interrupted with 14 days wash-out period. Before the~     trial and after both intervention periods we will analyze participants' blood for: ESR, white~     blood cell count, hsCRP, interleukin-6, oxidized LDL, glutathione peroxidase, superoxide~     dismutase, malondialdehyde, triglycerides, total cholesterol, HDL and LDL cholesterol,~     fibrinogen, factor VII and von Willebrand factor. We expect an improvement of these~     parameters after three weeks of EVOO consumption.~   "
201450|NCT00925782|"~     To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene~     Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing~     autologous stem cell transplant (ASCT).~   "
201451|NCT00925769|"~     This 2 part study will evaluate the safety and efficacy of a combination of Avastin, Tarceva~     and Xeloda (ATX) as second-line treatment in patients with locally advanced and/or metastatic~     pancreatic cancer. In the first part of the study, cohorts of patients will receive~     escalating doses of combination treatment to determine the maximum tolerated dose. The~     recommended dose will be used in the second part of the study to determine the efficacy of~     the ATX regime, in terms of its effect on disease progression. The anticipated time on study~     treatment is 3-12 months, and the target sample size is <100 individuals.~   "
201452|NCT00925756|"~     CCTG 590 is a open-label study to evaluate the impact of therapy intensification with~     Maraviroc (MVC) (a CCR5 inhibitor) to a stable suppressive HIV antiretroviral regimen on the~     rate of CD4+ T-cell recovery and gene expression profiles. Patients on a stable first-line~     HIV regimen with continued viral suppression and sub-optimal CD4+ T-cell counts will be~     eligible for this study. Those who are found to be eligible will have MVC (dose-adjusted to~     background HIV regimen) added to their current HIV regimen for 24 weeks. After the 24 week~     intensification, the MVC will be discontinued, the original antiretroviral regimen will be~     continued and the subjects will be followed for an additional 12 weeks.~      The investigators hypothesize that MVC will improve the rate of CD4 recovery. This improved~     CD4 recovery will be associated with favorable changes in gene expression profiles of genes~     involved with CD4 maintenance and circulation.~   "
201453|NCT00925743|"~     This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation,~     study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics~     (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment,~     crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK~     of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).~      There are 4 parts to the study:~      Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based~     on safety.~      Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated~     Dose (MTD) in an extended cohort of patients.~      Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the~     pharmacokinetic (PK) of Cabazitaxel.~      Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic~     (PK) of Cabazitaxel.~   "
201454|NCT00925730|"~     This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream~     1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a~     plastic film) over 8 days in patients with moderate to severe atopic eczema.~   "
201455|NCT00925717|"~     An observational, non-interventional, multi-centre study to provide further information on~     the utility of test for a predictive marker by investigating the current prevalence of high~     sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.~   "
201456|NCT00925704|"~     To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on~     the pharmacokinetics of oral calcitriol (ROCALTROL)~   "
201457|NCT00925691|"~     The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular~     septal position of the right ventricular lead in patients implanted with a pacemaker for~     conventional anti-bradycardia pacing indications requiring permanent right ventricular pacing~     ; the primary endpoint is the evolution of the left ventricular ejection fraction assessed by~     contrast echocardiography at 18-months follow-up.~   "
201458|NCT00925678|"~     Investigate safety/tolerability after a single dose intranasal administration of DSP-3025~     comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients~     out of season.~   "
201459|NCT00925665|"~     This study is a comparison of two techniques for endotracheal intubation (Glidescope versus~     Macintosh) in patients with odontogenic abscesses.~   "
201478|NCT00925418|"~     Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the~     stop of the epithelial proliferation), abscess, or pain. In this context, this randomized,~     monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention~     of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.~      Primary objective:~      Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with~     Taxotere®.~      Secondary objectives:~      Analysis of time of protection against onycholysis Estimation of the efficiency of~     cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove~   "
201692|NCT00922441|"~     The purpose of this study is to evaluate the antihypertensive efficacy and safety of~     Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential~     hypertension.~   "
201460|NCT00925652|"~     If residual breast cancer is found in the breast or lymph node tissue removed after~     preoperative chemotherapy, one may be at increased risk of breast cancer recurrence in the~     future. The purpose of this research study is to determine if having additional treatment~     after preoperative chemotherapy and surgery with bevacizumab and metronomic chemotherapy~     would make a difference in reducing the participants chance of breast cancer recurrence~     compared to the standard of care, which is observation alone. This study will evaluate the~     potential additional benefits from participating in an exercise and dietary intervention~     compared to the dietary intervention alone. Bevacizumab is an antibody that is made in the~     laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Bevacizumab~     works to slow or stop the growth of cells in cancer tumors by decreasing the blood supply to~     tumors. Bevacizumab has been approved by the U.S Food and Drug Administration to treat~     advanced colorectal, lung and kidney cancers. Metronomic chemotherapy also attacks tumor~     blood supply. Standard chemotherapy drugs are used, cyclophosphamide and methotrexate (CM),~     but in very small daily doses by mouth, well below the threshold where they can cause people~     to feel sick. Previous research studies have shown that women with breast cancer who take~     metronomic CM and bevacizumab feel very well, and the combination therapy is active in~     reducing their cancer. Participants in this study will also be provided with diet or diet and~     exercise counseling over the telephone. Studies have shown that many women who are treated~     for breast cancer will gain weight during and after their treatment, and may also experience~     fatigue and weakness. Many studies have shown that making changes in diet and increasing~     exercise can help prevent weight gain and also may increase energy and decrease other side~     effects of chemotherapy and other breast cancer treatments.~   "
201461|NCT00925639|"~     Hypoestrogenism, common in menopause, is responsible for systemic and metabolic changes~     affecting women's wellness, favoring hot flashes, urogenital atrophy and bone mass loss.~     Hormone reposition therapy (HRT) with estrogen or estrogen associated to progesterone is~     administered to minimize these effects. Meanwhile, the beneficial effects of HRT are known,~     there is still concern about its adverse effects such as thromboembolic and cardiovascular~     effects, increased risk of breast and endometrial cancer. Thus, there is an increasing~     interest in the development of phytohormonal HRT. The aim of the investigators' study is to~     evaluate the effects of concentrated extract of soy on hypercoagulation markers in menopausal~     women.~   "
201462|NCT00925626|"~     Randomized, single-blind trial in which one group of patients will be operated with a~     Mid-Vastus approach of the knee joint and the other group will undergo knee surgery with a~     Sub-Vastus approach.~   "
201463|NCT00925613|"~     The purpose of this study is to determine whether exchange of the double lumen tube before~     emergence with a laryngeal mask airway (Proseal) or a tracheal tube will reduce cough at~     emergence.~   "
201464|NCT00925600|"~     This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or~     worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab~     for bone loss due to androgen deprivation therapy.~   "
201465|NCT00925587|"~     The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin~     alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the~     correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.~   "
201466|NCT00925574|"~     The purpose of this study is to evaluate the safety and how the body affects a drug (CNTO~     1959) in healthy volunteers and in patients with psoriasis.~   "
201467|NCT00925561|"~     Coronary artery disease (CAD) is an important health concern for African Americans, who are~     diagnosed with CAD at high rates. Coronary artery calcification, which is characterized by~     calcium deposits in the coronary arteries, is a contributing factor to CAD. This study will~     examine the possible genetic causes of coronary artery calcification in African Americans.~   "
201468|NCT00925548|"~     EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the~     indication of breast cancer following the clinical hold on the investigational new drug~     application for tecemotide (L-BLP25).~   "
201469|NCT00925535|"~     Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis~     (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may~     decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of~     drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.~   "
201470|NCT00925522|"~     To demonstrate that ablation with the Therapy Cool Path Duo cardiac ablation system can~     eliminate ischemic VT and that its use does not result in an unacceptable risk of serious~     adverse events.~   "
201471|NCT00925509|"~     Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by~     curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of~     the study is to Investigate the accuracy of implants insertion in the anteroposterior way,~     using radiosurgical guidance.~   "
201472|NCT00925496|"~     Overall study design:~      This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study~     with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and PROMOS~     REVERSE™ (group B). The study will collect efficacy and safety data over 10 years.~   "
201473|NCT00925483|"~     Given the known increased risk of heart disease in hemodialysis patients, this study aims to~     evaluate the change in both size and function of the heart by using cardiac magnetic~     resonance imaging (MRI) in patients undergoing either daily long (4 hours, 6 times weekly),~     daily short (2 hours 6 times weekly), or alternate day conventional (4 hours, 3 times weekly)~     and alternate day long (8 hours, 3 times weekly) dialysis for 6 months from randomization.~     The patients are randomly put in the groups based on predetermined randomization schedule and~     the cardiologist trained in cardiac MRI readings is blinded to the patient treatment~     schedule. Given that changes in heart function may be seen with cardiac imaging techniques~     within 6 months, the expectation is that groups on daily treatment may have better outcome~     for this parameter as changes in volume and blood pressure may also be affected in a positive~     way in patients on daily dialysis.~   "
201474|NCT00925470|"~     Evaluation of target organs impairment on patients suffering from high blood pressure without~     known cardio vascular or renal disease, stratified on blood pressure control.~   "
201475|NCT00925457|"~     The purpose of this retrospective observational study is to obtain information to confirm or~     contradict the results of prior studies on domperidone and sudden cardiac death. The~     population studied are the Saskatchewan residents who used domperidone or another type of~     medication known as a Proton Pump Inhibitor (PPI) between 1990 and 2005. Information will be~     collected from various sources including the Saskatchewan Health (SH) database and Cancer~     Registry.~   "
201476|NCT00925444|"~     The aim of this study is to compare the efficacy of FORESEAL with stapling alone or~     associated with tissue sealant or glue in terms of air leakage duration after lung resection~     for cancer.~      Hypothesis: to show a significant difference of 1 day in the average duration of air leakage~     between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).~   "
201479|NCT00925405|"~     Objectives:~      The objective of this single-arm, prospective study is to perform annual mammography and MRI~     breast cancer screening in women who underwent mantle-field irradiation between 1970-1995 at~     M. D. Anderson Cancer Center in order to compare the ability of MRI and standard mammography~     to identify breast cancer. In addition, we will determine whether the combination of breast~     MRI and mammography identifies smaller, earlier-stage tumors, which would lead to improved~     cure rates. We will also take the opportunity to determine the incidence and stage of breast~     cancer in this high-risk cohort.~   "
201480|NCT00925392|"~     This study is being performed to measure the amount of the antibiotic doripenem (study drug)~     found in the fluid and cells of the lung and blood after receiving three doses of doripenem.~     The major objectives of this research are to see how much and for how long doripenem gets~     into the fluids and cells of the lungs of healthy adult subjects.~   "
201481|NCT00925379|"~     Evaluation of the frequency of familial cases of renal HYPODYSPLASIA~   "
201482|NCT00925366|"~     At this point in time the approach to the diagnosis of rotator cuff tendon tears is not~     consensual. The French surgeons, considering they have a good experience of this method,~     preferably use a shoulder CT-arthrography. Whereas in the United States surgeons rather rely~     on MRI or MR-arthrography of the shoulder. However, nobody can say which of these three~     examinations is most precise and gives the best information. We proposed to carry out the~     three examinations at the same time in a large number of patients who needed to be operated~     for a rotator cuff tendon tear and then to compare the results of each of these examinations~     with the operative observations.~   "
201483|NCT00925353|"~     The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine~     gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication~     to reduce discomfort during screening mammography does not result in adverse effects,~     electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or~     its principal metabolite, monoethylglycinexylidide (MEGX).~   "
201484|NCT00925340|"~     A two group randomized design will be used to test the primary hypothesis that the~     experimental intervention will reduce alcohol consumption and alcohol-related negative~     consequences significantly more than a comparison family-based psychoeducation condition in~     both an identified alcohol-using adolescent (12- 18 years old) and his/her teenage sibling~     (the sibling can be 3 years older or younger than teen with the sibling's age between 12-21~     years old). The experimental condition consists of the Family Check-up, while the comparison~     condition is a less intense parenting psychoeducation program. Time points will include~     follow-ups at 3, 6, and 12 months.~   "
201485|NCT00925327|"~     This is a compassionate treatment protocol for the use of the UV-X system for corneal~     collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have~     conditions that limit their capacity to comply with the cross-linking treatment procedures~     required by ongoing clinical trials.~   "
201486|NCT00925314|"~     The purpose of this study is to assess the safety, efficacy, and immunological response to~     the study product, TLI, as an adjuvant therapy in subjects with Stage III Melanoma.~      Normal cells in the body have an established lifespan. Cancer cells on the other hand have~     the ability to continue to divide into new cells indefinitely. More than 85% of cancer has~     this ability because of an enzyme found in the cancer cell. The Investigational Product,~     Transgenic Lymphocyte Immunization (TLI), is aimed at helping the immune system target this~     enzyme found in most cancerous cells.~      Subjects who meet all inclusion and exclusion criteria will undergo a leukapheresis in which~     white blood cells will be collected and used to manufacture their own personal study product.~     Subjects will receive 3 infusions of TLI roughly 1 month apart and will be followed over a 2~     year period with routine laboratory draws, computed tomography (CT) scans and physical exams.~   "
201487|NCT00925301|"~     The purpose of this study is to compare the effect of AT1001 (migalastat hydrochloride)~     versus placebo on kidney GL-3.~   "
201488|NCT00925288|"~     The primary objectives of this study are to determine the acceptance and potential for the~     effective use of HPV vaccine in the standard and a modified schedule in female sex workers.~     Secondary objectives include ascertaining the prevalence of HPV types among female sex~     workers by age and sexual experience.~   "
201489|NCT00925275|"~     The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry~     and pharmacokinetics of I-131-CLR1404.~   "
201490|NCT00925262|"~     The purpose of this study is to determine the relative effectiveness of three different~     mental health counseling interventions in the treatment of mental health problems commonly~     affecting torture and trauma survivors living in Kurdistan, Iraq.~   "
201491|NCT00925249|"~     This research will help doctors interested in the usefulness of a new test to discover hidden~     tuberculosis infections in patients diagnosed with rheumatoid arthritis (RA). This new test~     is called Quantiferon-Gold (QFT-G). After immune system medicines that block TNF-alpha (a~     protein manufactured by white blood cells to stimulate and activate the immune system in~     response to infection or cancer) started to be used, the rate of tuberculosis infections in~     patients treated with these medicines has increased. Doctors think that the investigators may~     be missing some tuberculosis infections that were hidden before the medicine is started. This~     new QFT-G test might better diagnose these hidden tuberculosis infections than the current~     tuberculosis skin test, also known as a PPD/TST. The investigators would like to compare~     these two tests to find out which is better at detecting these hidden infections. At the same~     time the investigators will measure the strength of the patient's immune system with a blood~     test. If you are being considered for a TNF-alpha inhibitor medicine, or are getting the~     patient's routine PPD/TST, the investigators are asking for the patient's participation.~   "
201492|NCT00925236|"~     The research involves the establishment of a cohort including as much as possible cases of~     macrothrombocytopenia related to a MYH9 syndrome and the study of mutations and~     polymorphisms of MYH9 gene in all these patients. As MYH9 syndrome is an autosomal dominant~     disorder, patients should be heterozygous for a MYH9 gene mutation.~      The main goal of our project is looking for correlations between genotype and phenotype. It~     is planned to characterize the phenotype and genotype of a cohort of patients, including~     family members that will be addressed during the study in order to better understand the~     platelet disorder and improve the epidemiological knowledge of MYH9 syndrome. The data will~     be recorded in a database.~   "
201493|NCT00925223|"~     Brain-derived neurotrophic factor (BDNF), originally known to be a member of the nerve growth~     factor family, has aroused attention as a modulator in visceral hyperalgesia recently.~     Visceral hypersensitivity is recognized as a clinical hallmark in IBS patients. So in this~     study, the investigators will focus on the role of BDNF in colonic hyperalgesia in IBS~     patients.~   "
201494|NCT00925210|"~     Patients presenting with solitary or multiple lung nodules often require tissue confirmation~     in order to guide further management and determine if the lesion is benign or malignant.~     Several bronchoscopic techniques have emerged which have significantly improved the~     diagnostic yield of bronchoscopy in this setting, and in particular the combination of~     peripheral Endobronchial Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy~     (ENB) has resulted in diagnostic yields of nearly 90%. In an attempt to reduce the~     significant cost of this combined approach, the sequential use of pEBUS followed by the more~     costly ENB technique only if a lesion is not identified on the ultrasound image could be as~     accurate. This study aims to determine the diagnostic yield of this sequential approach in~     patients with lung nodule(s).~   "
201495|NCT00925197|"~     The aims of the study are to prove correlation between laboratory and patient self-testing~     (PST) measurements, estimation of INR variability within a target therapeutic zone and~     frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve~     replacement.~   "
201496|NCT00925184|"~     The aim of this research project is to establish a students' perspective to most medical~     schools in Taiwan. We expect that these surveys will provide helpful information to~     candidates for selection of medical school before admission, and will also be a useful~     reference guide to improve quality of medical education to our governmental policy makers.~   "
201497|NCT00925171|"~     Chronic obstructive pulmonary disease (COPD), a preventable and treatable condition, is a~     major healthcare problem with huge human and economic costs. It affects 3 million people,~     results in 1.4 million consultations, causes 30,000 deaths, and costs £800M per year in the~     UK. Considerable research expenditure is devoted to finding new and expensive interventions.~     However pulmonary rehabilitation (PR) is an available therapeutic option with good evidence~     of benefit for patients in terms of quality of life and daily functioning.~      The primary objective of the study is to evaluate the effectiveness and cost effectiveness of~     the addition of a maintenance programme following pulmonary rehabilitation in patients with~     COPD when compared to standard care.~      The secondary objective is to identify baseline characteristics that will predict improvement~     in pulmonary rehabilitation programmes and adherence to maintenance strategies. By measuring~     a series of demographic, clinical, physiological, psychological and biochemical parameters~     the researchers hope to be able to predict those patients who are likely to receive the~     greatest benefit from pulmonary rehabilitation.~      An additional objective will be to prepare a detailed maintenance programme manual. This will~     be available to other centres providing pulmonary rehabilitation at the conclusion of the~     study~   "
201498|NCT00925158|"~     BACKGROUND: Endoscopy was first used in plastic surgery for the treatment of frontal~     rhytides. This minimally invasive approach allows the treatment of frontal wrinkles using a~     practical procedure that does not directly interfere with the frontalis muscle, acting only~     on its antagonists.~      It is also possible to treat the middle third of the face, but these evolutions depends on~     special surgical instruments. Videoendoscopic approach in rhytidoplasty have been improved by~     new devices and surgical instruments.~      The mid third of the face can be treated in different ways. Zygomatic projection can be~     achieved by the use of the Dissector Assisted Malar Elevation (DAME) procedure.~      AIM: Evaluate the zygomatic projection achieved by DAME in videoendoscopic rhytidoplasties.~      METHODS: 30 non-white female patients, 30 to 59 years old, will be submitted to~     videoendoscopic rhytidoplasty with malar elevation by the DAME. Pre- and post-operative~     facial appearance will be evaluated by digital photogrammetry.~   "
201499|NCT00925145|"~     There is a move to scarless surgery and this achieved by doing laparoscopic abdominal~     surgery though a single small umbilical incision. A technique for laparoscopic appendectomy~     done through a single incision utilizing conventional instruments has been developed. The~     operative risk of the single incision approach is no different that the standard three~     incision laparoscopic appendectomy. The goal is to study the operative time, length of~     hospital stay, and complications from this operation.~   "
201500|NCT00925132|"~     The purpose of this study is to treat metastatic melanoma with a combination of standard~     chemotherapy (decitabine and Temozolomide in a dose escalation scheme) with an study drug~     called panobinostat. This combination is proposed to unlock genes that may contribute to~     mechanisms that cause tumor growth.~      The primary objectives of this study are:~        -  To evaluate the safety and tolerability of the proposed schedule of decitabine,~          temozolomide and panobinostat in the treatment of metastatic melanoma.~        -  To define any Dose Limiting Toxicity (DLT) and maximum tolerated dose (MTD) of the~          combination of decitabine, temozolomide and panobinostat.~   "
201501|NCT00925119|"~     Beta-blockers are medications used to treat cardiovascular disease (CVD) symptoms, including~     high blood pressure and chest pain. People with diabetes who receive beta-blockers may~     experience adverse health effects, but the exact cause of why this happens remains unknown.~     This study will examine the genetic factors that may influence how atenolol, a beta-blocker~     medication, affects fat breakdown, blood sugar levels, and heart function in people with type~     2 diabetes.~   "
201502|NCT00925106|"~     The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected~     to provide more favorable bioavailability characteristics than the present commercial~     formulation.~   "
201503|NCT00925093|"~     Three different antibiotics are used to prevent infection in case of neurosurgery - this~     study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal~     fluid (surrounding the brain).~   "
201504|NCT00925080|"~     The purpose of this study is to evaluate safety and accuracy of the IVBG System (the~     System) when used to track blood glucose in insulin treated subjects with diabetes mellitus~     in an in-clinic setting for up to 72 hours (per subject). Reference blood glucose~     measurements will be collected across the entire reportable range of the System (e.g., 40 400~     mg/dL) with adequate sampling at the upper and lower ends of this range. IVBG System accuracy~     will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI~     glucose levels < 75 mg/dL, and within ±20% at YSI glucose levels >75 mg/dL).~   "
201507|NCT00925028|"~     Atrial Fibrillation is a heart condition in which people are treated with blood thinners such~     as warfarin to decrease the risk of stroke. Large studies have shown that when patients~     adjust their own dose of warfarin, similar to insulin, results are better.~      The purpose of this study is to evaluate whether implementing this method of warfarin~     management is beneficial in a Canadian primary care clinic. Patients will be educated on how~     to adjust their own warfarin doses when necessary using simple charts. The success of patient~     self management will be compared against management by a physician.~   "
201508|NCT00925015|"~     The purposes of this study were to assess the safety, tolerability, pharmacokinetic~     interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab~     and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.~   "
201509|NCT00925002|"~     This is a Phase 3, open-label study designed to obtain additional, long-term, open-label~     safety and efficacy data for Fx-1006A and to continue to provide patients with 20 mg oral~     Fx-1006A (soft gel capsule) who have completed either Protocol Fx-006 (a 1 year, open-label~     extension study to Protocol Fx-005 which is a randomized, double-blind, placebo-controlled,~     18-month study to evaluate the safety and efficacy of Fx-1006A) or Protocol Fx1A-201 (a Phase~     2, open-label study to evaluate TTR stabilization as well as the safety and tolerability of~     Fx-1006A) until market availability of Fx-1006A in individual patients' country of residence.~      Patients who successfully complete Protocol Fx-006 or Fx1A-201 will report to the clinical~     unit on Day 0 (Baseline) to sign the informed consent form and determine their eligibility~     for Protocol Fx1A-303. In addition, on Day 0 (Baseline), patients will have their entrance~     criteria reviewed and medical history and demography for all patients will be obtained. The~     relevant end of study assessments from Protocols Fx1A-201 and Fx-006 will serve as Baseline~     assessments for Protocol Fx1A-303 if these examinations were performed within 30 days of Day~     0 (Baseline). For any patient successfully completing Protocol Fx-006, the Karnofsky~     Performance Scale Index will be assessed and the cranial nerve and upper limb components of~     the NIS will be performed and combined with the NIS-LL data from the end of study visit from~     Protocol Fx-006.~      If there is more than 30 days between the final study visit of Fx-006 or Fx1A-201 and Day 0~     (Baseline) of Fx1A-303, all Day 0 study procedures will be performed (i.e., no data from the~     final study visits from the previous studies will be utilized).~      Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e.,~     first dose) and will return to the clinical unit for study visits every 6 months.~      Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit~     to the clinical unit and, if female, a urine pregnancy test will be performed. An abbreviated~     physical examination (including weight and vitals signs) will be conducted at every other 6~     month visit. A telephone call will be made at 3-month intervals between clinic visits to~     assess safety and the use of concomitant medications.~      For the evaluation of efficacy, the NIS, Norfolk QOL-DN, and Karnofsky Performance Scale~     Index will be performed on an annual basis (i.e., every other 6-month visit).~      An end of study visit will occur upon patient withdrawal (for any reason), program~     discontinuation by the Sponsor, or upon market availability of Fx-1006A in individual~     patients' country of residence.~   "
201510|NCT00924989|"~     A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent~     OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who~     received at least 1 but no more than 2 prior drug regimens~   "
201511|NCT00924976|"~     Representative payees, mostly family members, manage Social Security Administration funds of~     more than one million people with psychiatric disabilities. Although studies show payeeship~     can be used coercively, foster dependency, reduce work incentives, lead to family conflict~     and even violence, there has been little systematic research on how to lower these~     significant barriers to community integration.~      The investigators' long term goal is to promote recovery among adults with psychiatric~     disabilities who have payees by reducing downsides associated with what has been called the~     nation's largest guardianship system. The investigators' objective in the current~     application is to evaluate a pilot-tested, stakeholder-informed intervention that is grounded~     in principles of psychiatric rehabilitation and encourages consumers with psychiatric~     disabilities and their family members to collaborate within the representative payee~     arrangement.~   "
201512|NCT00924963|"~     To measure and compare pain associated with venipuncture and peripheral intravenous catheter~     insertion among pediatric emergency department patients randomized to treatment with one of~     three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine,~     J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream. The~     investigators hypothesize that J-Tip® jet injection of 1% buffered lidocaine will provide~     superior local anesthesia compared to saline or lidocaine cream.~   "
201513|NCT00924950|"~     The purpose of this study is to determine whether using Taclonex ointment under a hydrogel~     patch is more effective than using the ointment alone in treating psoriasis. Taclonex~     ointment is currently FDA approved for use on psoriasis. The hydrogel patch is a type of~     adhesive pad and contains no medications. It is currently FDA approved and has been shown to~     be safe and virtually free of side effects. The hypothesis is that psoriatic plaques which~     are treated with Taclonex ointment under a hydrogel patch will be more effectively treated~     compared to psoriatic plaques treated with Taclonex alone.~   "
201514|NCT00924937|"~     The purpose of this study is to compare the effects of the consumption of two different~     dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular~     events of persons with coronary disease.~   "
201515|NCT00924924|"~     The purpose of this project is to determine if a worksite wellness intervention using a~     theoretically-based self-management model increases confidence for carrying out healthy~     behaviors and improves health practices of participating employees. The research questions~     are: 1) does the intervention produce between group differences in behavior self-efficacy and~     actual health behaviors, 2) are self-efficacy and performance of health behaviors related,~     and 3) do changes in self-efficacy result in changes in behavior.~   "
201516|NCT00924911|"~     Part 1 of this study will assess the relative bioavailability of GSK1322322 administered as~     one of three investigational tablets compared to powder in a bottle formulation.~     Pharmacokinetics of these three tablets will be evaluated and the investigation tablet with~     the optimal PK profile will be progressed to Part 2. In Part 2 the investigational tablet~     selected from Part 1 will be coadministered with food alone, an H2 blocker alone, or an H2~     blocker given in combination with ascorbic acid to evaluate the effect on GSK1322322~     pharmacokinetics. Plasma GSK1322322 PK profile, safety, and tolerability will be assessed~     from each dose group.~   "
201517|NCT00924898|"~     This is a pilot study of treatment of acute HIV infection with a once daily regimen of~     Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are:~        1. To determine the safety and tolerability, and the virologic and immunologic efficacy of~          FTC, TDF, and efavirenz given once daily to patients with acute HIV infection.~        2. To assess the impact of once daily therapy combined with a standardized adherence~          program on treatment adherence, virologic suppression, and rate of viral load decline in~          blood and infectious fluids (semen, cervico-vaginal secretions).~        3. To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents~          among persons diagnosed with acute HIV infection in the Southeastern United States.~   "
201518|NCT00924885|"~     The purpose of the study is to compare the pain experience between the patients that have had~     their transvaginal oocytes retrieval with ultrasound guidance performed with reduced single~     lumen needle (Vitrolife Sweden AB, Gothenburg) with the patients that have had follicle~     aspiration needle, 1.4 outer diameter (Vitrolife Sweden AB, Gothenburg), during the~     procedure.~   "
201519|NCT00924872|"~     To test the hypothesis that persons with stroke can safely and effectively learn to use power~     mobility devices. The primary objective of this project is to test the hypothesis that, with~     formal wheelchair skills training, people who have had a stroke and have been prescribed a~     power wheelchair will have a larger improvement in performance and safety scores on the~     wheelchair skills test than people who have not received wheelchair skills training.~   "
201520|NCT00924859|"~     The investigators aim to assess the overall accuracy of D-dimer values and FXIII activation~     peptide (FXIII-AP), using a newly developed ELISA test, to exclude CVT in patients with~     clinical suspicion of CVT.~   "
201521|NCT00924846|"~     Background/Objectives: Acute hypoxemic respiratory failure (AHRF) is a frequent cause of~     pediatric ICU admission. Early treatment with inhaled nitric oxide (iNO) plus conventional~     mechanical ventilation (CMV) improves oxygenation, responsiveness being significantly~     influenced by alveolar recruitment level. High-frequency oscillatory ventilation (HFV) is~     conceptually very attractive as constant mean airway pressure optimizes lung recruitment;~     this could maximize iNO effects.~      Aims: To analyze the effects of HFV on oxygenation indexes in AHRF children under CMV and~     iNO.~      Methods: Children with AHRF (oxygenation index ≥10) aged between one month and 14 years under~     CMV with PEEP≥10cmH2O and 5ppm iNO for 1h were randomly assigned to CMV (CMVG, n=12) or HFV~     (HFVG, n=12) in a crossover design. Children with chronic cardiac or pulmonary diseases were~     excluded. Patients were kept under one of the two ventilation modes for 8h, crossing to the~     other for 8h, and then back again to complete 24h observation. Blood gas analysis,~     oxygenation indexes, and hemodynamic variables were recorded at enrollment (Tind), 1h after~     iNO start and then every 4h (T4h etc). The Mann-Whitney U test compared group ages and PRISM~     scores, and the Fisher test genders. Moments and groups were compared by repeated measure~     analysis for independent groups. Significance was considered at p<0.05.~   "
201522|NCT00924833|"~     Exposure of healthy subjects to high altitude hypoxia elicits changes in cardiovascular,~     respiratory and metabolic features as weel as in exercise performance similar, for some~     aspects, to those observed in chronic heart failure. Exposure to high altitude hypoxia~     represents a suitable model to assess different treatments proposed for this pathological~     condition. Our aim was to evaluate the impact of two different third-generation beta-blockers~     used in heart failure (carvedilol and nebivolol) on cardiovascular, respiratory, metabolic~     profile and on exercise performance at high altitude.~   "
201523|NCT00924820|"~     The goal of this clinical research study is to learn if and how Avastin (bevacizumab) may~     affect cancer that has spread to the meninges of the brain or the spinal cord. The safety of~     this drug will also be studied.~      Objectives:~      1. Primary:~      1. Determine preliminary response data of intravenous bevacizumab in patients with NM~      a. As measured by clearance of malignant cells from the Cerebrospinal fluid (CSF) at 2, 4, 6,~     12, 18, and 24 weeks, then every 8 weeks up to 54 weeks, and~      b. Time to neurological progression (TTNP)~      2. Secondary:~        1. Evaluate the safety of intravenous bevacizumab in patients with NM~        2. Further describe the efficacy of this intervention as measured by~             1. improvement of MR imaging evidence of disease~             2. overall survival~             3. maintenance of quality of life~        3. Determine effects of systemically administered bevacizumab on CSF, serum, and urine~          Vascular endothelial growth factor (VEGF)levels levels~        4. Correlate changes in CSF VEGF with response measurements.~        5. Correlate primary tumor tissue VEGF expression with CSF VEGF levels~        6. Correlate urine VEGF levels with serum and CSF VEGF levels~        7. Evaluate serum and CSF VEGF index~   "
201524|NCT00924807|"~     The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be~     administered at the same time as standard treatment, which includes hormonal therapy and~     external beam radiotherapy.~   "
201525|NCT00924794|"~     This is a register-based, epidemiological study of HPV type distribution in women aged 18~     years and above with recurrent conization following a primary conization for high grade~     lesions/ microinvasive carcinomas. This study will involve data collection from different~     databases in the Cancer Registry of Norway.~   "
201526|NCT00924781|"~     This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance~     treatment for renal anemia in chronic kidney disease patients on dialysis who were previously~     receiving erythropoietin stimulating agents.~   "
201527|NCT00924768|"~     The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is~     safe (does not cause prolonged cough, shortness of breath or other problems), but causes~     changes in sputum cell samples that the scientists can measure. The investigators are also~     interested in seeing if the exposure to the endotoxin decreases the body's natural ability to~     clear mucus from the lungs.~   "
201528|NCT00924755|"~     The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as~     a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary,~     unilateral, open inguinal hernia repair.~   "
201529|NCT00924742|"~     The purpose of this study is to examine the pharmacokinetic properties of Tapimycin injection~     (piperacillin 4 g + tazobactam 0.5 g powder for injection) in healthy volunteers under~     fasting conditions.~   "
201530|NCT00924729|"~     This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5%~     ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after~     pre-operative topical administration in subjects undergoing cataract surgery.~   "
201531|NCT00924703|"~     This study is an extension of previous rAvPAL-PEG studies. Administration of rAvPAL-PEG will~     be continued to assess whether long-term dosing of rAvPAL-PEG is safe and can maintain~     reduced blood Phe concentrations in PKU subjects.~   "
201547|NCT00924495|"~     The purpose of this study is to explore the cortical regulation of the paraspinal muscles in~     chronic low back pain. These (possible) changes in regulatory mechanisms are being compared~     to other motor control tests in order to determine whether correlations are found.~     Furthermore the patients are being treated with repetitive transcranial magnetic stimulation~     (rTMS) and tested afterwards. The purpose is to find out if rTMS-therapy is capable of~     normalizing motor control deficits.~   "
201532|NCT00924690|"~     The goal of this research study is to design messages which can help people learn more about~     how to prevent colon cancer. Eligible participants will be asked to review a series of short~     cancer prevention messages and share their opinions on them. Participants also need to fill~     out a short survey with questions on their background and attitudes and knowledge about~     physical activity and colon cancer. The whole study can be completed online and will take~     less than 1 hour. After completing the entire study, participants will receive $25.~      If you are interested in participating in this study, please visit the following website:~      https://surveys.chaicore.com/preventcancer/~   "
201533|NCT00924677|"~     Chronic osteoarthritis (OA) pain of the knee is not effectively abrogated by the available~     non-pharmacologic or pharmacologic treatments. Radiofrequency (RF) neurotomy is a therapeutic~     alternative for chronic pain. Here, the researchers investigate the efficacy of RF neurotomy~     applied to articular branches (genicular nerves) in treating knee joint pain.~   "
201534|NCT00924664|"~     The purpose of this study is to investigate the safety and efficacy of tanezumab for chronic~     low back pain. Patients who were randomized and treated with study medication in a previous~     chronic low back pain parent study will be eligible to enroll in this safety extension~     study at the Preferred Rollover Time Point visit or at the Early Termination visit of the~     parent study upon discontinuation due to lack of efficacy.~   "
201535|NCT00924651|"~     RATIONALE: Physical activity may help lessen fatigue caused by cancer in patients receiving~     chemotherapy. It is not yet known whether a home-based walking and resistance-band exercise~     program is effective in lessening fatigue.~      PURPOSE: This randomized phase III trial is studying how well exercise works in lessening~     fatigue caused by cancer in patients undergoing chemotherapy.~   "
201536|NCT00924638|"~     The 2006 American Heart Association / American Stroke Association Council on Stroke~     Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic~     recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in~     order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation~     (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin~     for stroke prevention. Physicians can best optimize the use of medicines only if they can~     precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the~     time to first AF by 6 months' continuous rhythm monitoring versus control treatment in~     subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history~     of AF.~   "
201537|NCT00924625|"~     This study will be a small randomized clinical trial to test the effectiveness of~     neuromuscular electrical stimulation (NMES) to improve physical function and reverse muscle~     atrophy in patients with rheumatoid arthritis (RA). The investigators will also determine the~     mechanism by which NMES affects muscle hypertrophy and physical function. The proposed study~     will be the first step in demonstrating that NMES training is an effective alternative to~     highly intense volitional exercises (VE) in individuals with RA. After baseline testing, 60~     individuals with RA will be randomly assigned to a 16-week NMES program or highly intense VE~     program. Both programs will be applied based on the best current clinical evidence. Subjects~     will be re-assessed after intervention. Groups will be compared for differences in~     performance-based and self-reported lower extremity function, muscle volume, muscle strength,~     proportion and area of type I and II muscle fibers, fat content, and muscle oxidative~     capacity from pre- to post-intervention. Changes in physical function, muscle volume, and~     muscle strength will be correlated with proportion and area of type I and II muscle fibers,~     fat content, and markers of muscle oxidative capacity.~   "
201538|NCT00924612|"~     The purpose of the study is to determine the effect of food with various amounts of fat on~     the absorption of an oral testosterone undecanoate formulation.~   "
201539|NCT00924599|"~     The purpose of this study is to examine the feasibility of recruiting and providing a~     behavioral weight loss program prior to pregnancy to reduce gestational diabetes recurrence.~   "
201540|NCT00924586|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients~     scheduled for multi-slice CT, in a double-blind, randomized, placebo-controlled, parallel~     group, multi-center study.~   "
201541|NCT00924573|"~     Primary objective of this study is to confirm the efficacy of HOE490 O~     (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change.~      Secondary objectives of this study is to evaluate the safety of HOE490 O~     (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy~     parameters~   "
201542|NCT00924560|"~     This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a~     28-day OC regimen on bone mineral density (BMD) in adolescent females.~   "
201543|NCT00924547|"~     Oral supplementation of patients affected by cystic fibrosis with docosahexanoic acid (DHA)~     will result in normalization of the known fatty acid derangements in these patients and will~     diminish the production of proinflammatory isoprostanes such as 8-isoprostane-PGF2α.~   "
201544|NCT00924534|"~     The purpose of this study is to assess safety, tolerability, pharmacokinetics and~     pharmacodynamics of SLV337 in patients with type 2 diabetes~   "
201545|NCT00924521|"~     Whole grain intake beneficially affects body weight, body fat and glucose metabolism, and the~     investigators' previous work has shown that a high whole grain intake significantly reduced~     body fat in the abdominal region as measured by dual energy X-ray absorptiometry (DEXA)~     compared to a refined grain intake. Additional research is needed with regard to the~     mechanisms by which whole grains may affect visceral adiposity and the adipokines, which have~     been associated with risk for insulin resistance and type 2 diabetes. Therefore the proposed~     study aims to address these issues and in addition, includes exploratory work with adipocytes~     in cell culture to evaluate the effects of whole grains on adipocyte function.~      Hypothesis:~      There will be a greater reduction in visceral adiposity, indicators of insulin resistance~     (HOMA score), improvement in inflammatory status and improvement in adipokine levels after~     six weeks of a weight stable period and after six weeks of weight loss in subjects consuming~     6-9 servings compared to 0 servings of whole grains per day.~   "
201546|NCT00924508|"~     The primary objective of this clinical study is to determine whether occlusion of~     triamcinolone 0.1% cream (TAC) with hydrogel patch improves its efficacy in treating eczema.~     A secondary objective is to determine whether eczema improves under occlusion with hydrogel~     patch alone, without TAC.~   "
201549|NCT00924469|"~     The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus~     leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with~     prostate cancer (a disease in which cells in the prostate gland become abnormal and start to~     grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery~     to remove all or part of the prostate gland).~   "
201550|NCT00924456|"~     The purpose of this trial is to show that the Transcendental Meditation program can decrease~     blood pressure in young adults (college students) and is associated with decreased~     psychological distress and coping ability.~   "
201551|NCT00924443|"~     The purpose of the study is to determine if treatment of older patients indicated with~     untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive~     chemotherapy, can effectively be treated with Clofarabine.~   "
201552|NCT00924430|"~     To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin~     and simvastatin acid when co-administered in healthy male subjects~   "
201553|NCT00924417|"~     This is a randomized, controlled trial of a distraction protocol for peripheral intravenous~     line placement in the pediatric emergency department. Patients and parents will be randomized~     to one of two interventions: routine care or a teaching session about the cognitive technique~     known as distraction. The study seeks to enroll children ages 4-9, who are cognitively~     normal, who are without significant chronic medical illness, who are receiving intravenous~     line placement as part of routine care in the pediatric emergency department. Study~     investigators hypothesize that patients in the intervention group will report less pain than~     patients in the control group.~   "
201554|NCT00924404|"~     Is a xylitol nasal rinse better or worse than saline on patient satisfaction.~   "
201555|NCT00924391|"~     It is becoming increasingly clear that North Americans prefer dietary approaches to enhance~     health in favour of pharmaceutical approaches. Although the consumption of various~     phytosterol (PS)-enriched foods have been shown to be effective in lowering plasma~     cholesterol in a variety of food matrices, the lipid-lowering potential of PS-enriched~     soymilk has not been investigated. Therefore, the objective of this investigation was to~     examine the lipid-lowering efficacy of a PS-enriched soymilk beverage in comparison to a 1%~     dairy milk control. Twenty-three hypercholesterolemic subjects (Total-cholesterol and~     LDL-cholesterol ≥ 5.0 and 3.5 mmol/L, respectively) consumed 3 tetrapacs per day of a~     phytosterol-enriched soy beverage providing 1.95g PS/d or a 1% dairy milk control. The study~     was conducted as a 28 d controlled dietary intervention according to a completely randomized,~     two-period cross-over design.~   "
201556|NCT00924365|"~     Background:~        -  About 10,000 children in the United States have been living with HIV infection since~          birth. Little is known about the long-term effects of HIV infection and its treatment on~          the growth and development of these children.~        -  Because of their disease, many children with HIV face additional difficulties with their~          health, well-being and development, such as success in school and peer relationships.~      Objectives:~        -  To better understand how HIV infection and the medicines used to treat it affect the~          growth and development of children, adolescents and young adults who have been infected~          since birth or when they were very young.~        -  To develop ways to improve the quality of life for these individuals.~      Eligibility:~      -HIV-infected patients who were followed by the pediatric HIV program in NCI as of December~     2004, or an HIV-infected sibling of a participant.~      Design:~        -  Periodic evaluation of pubertal development; bone mineralization; body composition and~          fat distribution; liver, kidney and heart status; and behavioral, cognitive and academic~          or vocational outcome of the study group. Evaluations include the following:~        -  Physical examinations, including height and weight measurements and skin-fold thickness~          testing to measure body fat.~        -  Review of medical records and family history.~        -  Blood and urine tests, including pregnancy test in females who can bear children.~        -  DEXA scans (X-ray test to measure bone strength and how much fat, muscle and bone is in~          the body).~        -  Neuropsychological testing, including evaluation of language, thinking and~          problem-solving abilities.~        -  Magnetic resonance imaging (MRI): Test using a magnetic field and radio waves to examine~          brain structure and function.~        -  Oral glucose tolerance test: Blood sampling before and one time after the subject drinks~          a sugary solution to measure the body's ability to use sugar~   "
201557|NCT00924352|"~     The primary objective for the Phase I portion of the study is to determine the maximum~     tolerated dose (MTD) and dose limiting toxicities (DLTs) and for the Phase II portion of the~     study is to evaluate progression free survival (PFS). Secondary objectives are response rate,~     clinical benefit rate, and overall toxicity.~   "
201558|NCT00924339|"~     Familial hypercholesterolemia (FH MIM#143890), an inherited disorder of lipoprotein~     metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease~     is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL)~     and total cholesterol (TC), typically well above the 95th percentile for age and sex (1). A~     defective gene for the LDL-receptor is inherited from one parent (2). The disorder was first~     noted by Müller in 1939, including familial clustering of tendon xanthomas, high serum~     cholesterol and early MIs (3).~      The present study aims: a) to strengthen the evidence for the hypocholesterolaemic effect of~     soy protein in children and adolescents affected with FH b) to monitor the compliance of soy~     consumption as a possible causal factor linked to the variable lipaemic response observed in~     the previous study c) to assess certain safety markers of soy food consumption (hormone~     status, thyroid function, bone metabolism) 4) to monitor the adherence to the soy~     intervention additionally comprise collections of blood and urine samples.~      Hypothesis 1: Soya protein-substituted diets change total and LDL-cholesterol, Apolipoprotein~     B and uric acid serum concentrations.~      Primary parameters: Blood analysis~      Hypothesis 2: Children and adolescents with FH, in which the cholesterol, LDL-lipoprotein and~     Apolipoprotein B concentration is not influenced by means of soy protein substituted diet -~     is it because of a) the effect of non-responder? or b) subjects, who have no regularly~     dietary soya intake.~      Secondary parameters: isoflavones daidzein, glycetein, genistein and equol in the urine~     samples~   "
201584|NCT00923975|"~     The purpose of this study is to evaluate a Diabetes data management program in the hands of~     potential users, both lay persons and healthcare professionals. With this data management~     system glucose results from the DIDGET TM meter can be uploaded to a secure website and used~     by adults with diabetes, by parents and guardians of children with diabetes, and by health~     care professionals to monitor diabetes by recognizing trends and patterns in blood sugar~     levels.~   "
201693|NCT00922428|"~     The purpose of this observational study is to give an overview of the use of PASCOE-Agil~     HOM-Injektopas in a 2-4 week treatment of rheumatic disorders.~   "
201862|NCT00920218|"~     The purpose of this observer-blind study is to evaluate the safety and immunogenicity of~     GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when~     administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.~   "
201559|NCT00924326|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with B~     cell lymphomas or leukemias that involves taking white blood cells from the patient, growing~     them in the laboratory in large numbers, genetically modifying these specific cells with a~     type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to~     the patient. This type of therapy is called gene transfer. In this protocol, we are modifying~     the patient s white blood cells with a retrovirus that has the gene for anti-CD19~     incorporated in the retrovirus.~      Objective:~      The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these particular tumor-fighting cells (anti-CD19 cells) cause tumors to shrink.~      Eligibility:~      - Adults age 18-68 with B cell lymphomas or leukemias expressing the CD19 molecule.~      Design:~      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo~     a history and physical examination, scans, x-rays, lab tests, and other tests as needed~      Leukapheresis: If the patients meet all of the requirements for the study they will undergo~     leukapheresis to obtain white blood cells to make the anti-CD19 cells. {Leukapheresis is a~     common procedure, which removes only the white blood cells from the patient.}~      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the~     conditioning chemotherapy and the anti-CD19 cells. They will stay in the hospital for about~      4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.~   "
201560|NCT00924313|"~     Background:~        -  Prostate cancers are difficult to see on most imaging studies such as X-rays, computed~          tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and~          conventional positron emission tomography (PET) scans.~        -  An experimental radioactive tracer called 11C-acetate accumulates in prostate tumor~          cells and may help find prostate cancers more accurately than other imaging methods.~      Objectives:~        -  To determine the accuracy of prostate tumor imaging using the tracer 11C-acetate.~      Eligibility:~        -  Patients 18 years of age and older who are undergoing surgery for localized prostate~          cancer at the National Institutes of Health (NIH) Clinical Center.~      Design:~        -  Patients have a positron emission tomography (PET scan). For this test, an intravenous~          (IV) line is placed in the patient's arm and the patient lies on a table inside the~          donut shaped scanner. (11)C-acetate is injected into the vein through the catheter and~          images of the lower pelvis and abdomen are obtained over 30 minutes.~        -  Patients have an endorectal coil MRI scan. For this test, a tube is placed in the~          rectum, just behind the prostate, to increase the amount of signal received by the~          magnetic resonance (MR) unit. Other coils may be wrapped around the pelvis to further~          improve the quality of the scan. The patient lies on the scanning table for about 75 to~          90 minutes while images are obtained. During the scan, a contrast agent called~          gadolinium is injected through an intravenous (IV) line to brighten the images.~   "
201561|NCT00924300|"~     The primary objective of this protocol is to test the feasibility and utility of obtaining~     magnetoencephalography (MEG) recordings in healthy children and also in children who have a~     psychiatric or developmental disorder. Secondary objectives are to examine and compare~     typical and atypical motor, sensory, and cognitive functioning as recorded by MEG, and to~     identify subpopulation groups for which MEG may be optimal in order to establish feasibility~     of future hypothesis-driven MEG research.~   "
201562|NCT00924287|"~     Background:~        -  Human epidermal growth factor receptor-2 (Her-2) is a gene found in both normal cells~          and cancer cells. Extra copies of the gene (overexpression) can cause too many Her-2~          proteins (receptors) to appear on the cell surface and cause tumors to grow.~        -  An experimental procedure developed for treating patients with cancer uses blood cells~          found in their tumors or bloodstream. The cells are genetically modified using the~          anti-Her-2 gene and a type of virus. The modified cells (anti-Her-2 cells) are grown in~          the laboratory and then given back to the patient to try to decrease the size of the~          tumors. This is called gene therapy.~      Objectives:~        -  To determine whether advanced cancers that overexpress Her-2 can be treated effectively~          with lymphocytes (white blood cells) that have been genetically engineered to contain an~          anti-Her-2 protein.~      Eligibility:~        -  Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond~          the original site) and for whom standard treatments are not effective.~        -  Patient's tumor overexpresses Her-2.~      Design:~        -  Workup with scans, x-rays and other tests.~        -  Leukapheresis to obtain cells for preparing the anti-Her-2 cells for later infusion.~        -  1 week of chemotherapy to prepare the immune system for receiving the anti-Her-2 cells.~        -  Infusion of anti-Her-2 cells, followed by interleukin-2 (IL-2) treatment. The cells are~          given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a~          vein every 8 hours for a maximum of 15 doses.~        -  Periodic follow-up clinic visits after hospital discharge for physical examination,~          review of treatment side effects, laboratory tests and scans every 1 to 6 months.~   "
201563|NCT00924274|"~     Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a~     risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized~     by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total~     cholesterol (TC). The purpose of this study is to compare the effect of a diet low in~     saturated fats but enriched either with rapeseed oil (RO) or sunflower oil (SO) in children~     and adolescents with FH on serum lipoproteins.~   "
201564|NCT00924261|"~     Based on their preliminary quantitative gait findings suggesting that limited passive hip~     extension range is a key functionally limiting impairment affecting gait, the investigators~     propose a supervised, specific stretching exercise with the aim to improve both peak hip~     extension and overall gait performance. While one goal is to demonstrate that reduced peak~     passive hip extension is a key, functionally significant, but reversible, impairment another~     is to improve our understanding of the relationship between impairment, functional limitation~     and gait ability.~   "
201565|NCT00924248|"~     The objective of this Post Marketing Surveillance (PMS) is to gain information about safety~     and efficacy in real practice~   "
201566|NCT00924222|"~     Organ protection, volatile anesthetics, postconditioning.~      Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either~     propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the~     blood.~   "
201567|NCT00924209|"~     Background:~        -  Surgical resection is the treatment of choice for patients with lung cancer, and cure~          after resection generally depends on whether lymph nodes are involved. A patient with~          Stage IIIA (N2) lung cancer has cancer in the lymph nodes involving the center of the~          chest (mediastinum).~        -  Studies have shown that surgery alone as a treatment for Stage IIIA (N2) lung cancer is~          not as effective as chemotherapy followed by surgery.~        -  Giving chemotherapy upfront may prevent the spread of Stage IIIA (N2) lung cancer~          tumors, and may shrink the tumors to allow adequate surgery to be performed. It is also~          thought that chemotherapy is usually better tolerated before major surgery than after,~          so higher doses can be given.~      Objectives:~        -  To determine the effectiveness of the combination of three anti-cancer drugs~          (gemcitabine, cisplatin, and bevacizumab) given before surgery.~        -  To find out what effects this drug combination may have on the patient and the cancer.~        -  To determine if the combination of all three drugs given prior to surgery is more~          effective and as safe, safer, or less safe than other drug combinations given before~          surgery.~      Eligibility:~        -  Patients with Stage IIIA (N2) lung cancer who have not had chemotherapy, radiation, or~          surgery to treat the cancer.~      Design:~        -  Evaluations before the treatment period to determine eligibility:~        -  Physical examination, including vital signs and body weight checks, and pregnancy test~          for women who can become pregnant.~        -  Tests to evaluate heart and lung function, such as an echocardiogram.~        -  Blood and urine tests.~        -  Disease evaluation with computed tomography (CT), chest X-ray, positron emission~          tomography (PET) scans, and bronchoscopy/mediastinoscopy (examinations of the inside of~          the chest and lungs).~        -  Treatment with intravenous gemcitabine, cisplatin, and bevacizumab for three 21-day~          cycles.~        -  Cycles 1 and 2 - Gemcitabine on day 1 and day 8, cisplatin on day 1, bevacizumab on day~          1.~        -  Cycle 3 - Gemcitabine on day 1 and day 8, cisplatin on day 1 (no bevacizumab).~        -  Physical examinations and tests will be conducted throughout each cycle.~        -  Surgery will take place 4 to 6 weeks after the last cycle if heart and lung functions~          are satisfactory and if the cancer remains stable.~        -  Chemotherapy (four 21-day cycles of cisplatin and etoposide treatments), further~          evaluations and examinations, and followup studies will take place 4 to 8 weeks after~          the surgery.~   "
201568|NCT00924196|"~     Background:~      Neurofibromatosis Type 1 (NF1) is a genetic disorder in which patients are at increased risk~     of developing tumors (usually non-cancerous) of the central and peripheral nervous system.~     The disease affects essentially every organ system.~      The natural course of NFI over time is poorly understood. For most patients the only~     treatment option is surgery. A better understanding of NF1 may be helpful for the design of~     future treatment studies.~      Objectives:~      To evaluate people with NF1 over 10 years in order to better understand the natural history~     of the disease.~      To characterize the patient population and to examine how NFI affects patients quality of~     life and function.~      Eligibility:~      Children, adolescents, and adults with NF1.~      Design:~      Participants have a comprehensive baseline evaluation including genetic testing, tumor~     imaging, pain and quality-of-life assessments, and neuropsychological, motor and endocrine~     evaluations.~      Patients are monitored every 6 months to every 3 years, depending on their individual~     findings at the baseline study. Tests may include the following, as appropriate:~        -  Medical history, physical examination and blood tests.~        -  Whole body and face photography to monitor visible deformities.~        -  Neuropsychological testing, quality-of-life evaluations, motor function tests,~          endocrinologic evaluations, heart and lung function tests, hearing tests, bone density~          scans and other bone evaluations.~        -  MRI and PET scans to detect and assess plexiform neurofibromas (tumors that arise from~          nerves and can cause serious problems), paraspinal neurofibromas (tumors that arise from~          nerves around the spine and can cause problems by compressing the spinal cord), and~          malignant peripheral nerve sheath tumors (a type of cancer that arises from a peripheral~          nerve or involves the sheath covering the nerve).~        -  Eye exams, MRI scans and PET scans to evaluate optic pathway gliomas (tumors arising~          from the vision nerves or the brain areas for vision) and the chemicals within the tumor~          and brain.~        -  Eye exams and photographs to evaluate the development of Lisch nodules (non-cancerous~          tumors on the eye).~        -  Photographs of dermal neurofibromas (tumors of the skin), cafe-au-lait spots (dark or~          pigmented areas on the skin that are often the first signs of NF1) and other skin~          problems.~        -  Pain evaluations to monitor the different types of pain patients experience, causes of~          the pain, how often the pain occurs, effect of the pain on quality of life, and what~          pain medications and alternative treatments, such as acupuncture, are effective....~   "
201569|NCT00924183|"~     The primary goal of this study is to compare a new symptoms rating questionnaire, called the~     Vancouver Semi-Structured Interview for Depression (V-SID), to the traditionally used~     questionnaires. The investigators predict that the V-SID will be more sensitive to patients'~     improvement than are traditional questionnaires.~   "
201570|NCT00924170|"~     BACKGROUND:~        -  Cluster of differentiation 25 (CD25) (p55, Tac or interleukin 2 receptor (IL2R) alpha)~          is strongly expressed in virtually 100% of patients with adult T-cell leukemia/lymphoma~          (ATL), a highly aggressive human T-lymphotropic virus type 1 (HTLV-1) related malignancy~          responding poorly to chemotherapy.~        -  In ATL, the humanized anti-CD25 monoclonal antibody (Mab) daclizumab produced 13-14%~          responses, and the anti-CD52 Mab Alemtuzumab (Campath-1H) produced response lasting~          greater than 2 months in 30% of 23 patients.~        -  LMB-2 is an anti-CD25 recombinant immunotoxin containing variable domains of murine MAb~          anti-Tac and truncated Pseudomonas exotoxin.~        -  In a phase I trial at National Cancer Institute (NCI), the maximum tolerated dose (MTD)~          of LMB-2 was 40 microg/Kg intravenous (IV) given every other day for 3 doses (every~          other day (QOD) times 3). LMB-2 induced greater than 90% tumor reduction rapidly in all~          3 ATL patients on protocol, but achieved only 1 partial response due to rapid tumor~          progression and/or immunogenicity.~        -  In preclinical models, response from recombinant immunotoxins is limited by high~          concentrations of soluble receptor in the blood and especially in the interstitial space~          of the tumor. Synergism was observed with chemotherapy and immunotoxins, possibly due to~          reduction of soluble receptor in tumor interstitium.~      OBJECTIVES:~      -To determine, in nonrandomized fashion, if after verifying its safety, fludarabine and~     cyclophosphamide (FC) prior to LMB2 for ATL can result in low immunogenicity and a rate of~     major response lasting greater than 2 months, which may be an improvement over that~     demonstrated previously from Alemtuzumab (CAMPATH).~      Secondary objectives:~        -  To determine the effect of 1 cycle of FC alone in ATL.~        -  To examine progression-free and overall survival in ATL after FC/LMB-2.~        -  Evaluate pharmacokinetics, toxicity, and monitor soluble CD25 and other tumor marker~          levels in the serum.~        -  To study the effects of LMB-2 plus FC on normal B- and T-cell subsets by~          fluorescence-activated cell sorting (FACS).~      ELIGIBILITY:~        -  CD25 plus ATL, untreated or with prior therapy~        -  Eastern Cooperative Oncology Group (ECOG) 0-2, absolute neutrophil count (ANC),~          platelets and albumin at least 1000, 75,000, and 3.0.~      DESIGN:~        -  Fludarabine 25 mg/m(2) IV days 1-3~        -  Cyclophosphamide 250 mg/m(2) IV days 1-3~        -  LMB-2 30-40 micro g/Kg IV days 3, 5 and 7.~        -  LMB-2 dose: Begin with 30 microg/Kg times 3. Escalate to 40 microg/Kg if dose limiting~          toxicity (DLT) in 0/3 or 1/6 at 30 microg/Kg. Continue at 40 microg/Kg if 0-1 of 6 have~          DLT at 40 microg/Kg.~        -  Administer cycle 1 with FC alone. Two weeks after starting cycle 1, begin up to 6 cycles~          of FC plus LMB-2 at minimum 20-day intervals.~        -  Accrual goals: 29-37 patients, which includes 4 replacements....~   "
201571|NCT00924157|"~     This study will investigate whether the lacto-tripeptide Ile-Pro-Pro (IPP) improves the~     function of the endothelium in patients with coronary artery disease. The study has a~     crossover design. Participants will be treated with a protein hydrolysate rich in IPP for 12~     weeks and placebo for 12 weeks with a four-week rest period between treatment periods. The~     investigators will use ultrasound to test the function of the endothelium in the brachial~     artery before, after 6 weeks, and after 12 weeks of each treatment. Blood will be collected~     before and after each treatment. The investigators hypothesize that IPP will improve~     endothelial function.~   "
201572|NCT00924131|"~     Background:~        -  Researchers are greatly interested in knowing more about the long-term effects of~          various treatments for cancers such as Hodgkin's disease, particularly from those who~          have lived 20 to 30 years after treatment.~        -  Patients who were treated at the National Institutes of Health (NIH) may have undergone~          different treatments for which more long-term information is needed.~      Objectives:~        -  To examine the body systems of long-term survivors of Hodgkin's disease to see if there~          are any long- term consequences of treatment for Hodgkin's disease.~        -  To learn more about the long-term effects of cancer treatments.~      Eligibility:~        -  Survivors of Hodgkin's disease who were previously treated at the NIH.~        -  Participants must be at least 18 years of age.~      Design:~        -  Participants will need to sign consent forms to allow researchers to obtain~          documentation of medical history, including prior treatment for Hodgkin's disease and~          prior NIH treatment, including protocol number, where applicable:~        -  Pertinent medical records, pathology reports, and radiographic imaging studies will be~          reviewed.~        -  Primary care physician's name, address, and other contact information are also required.~        -  Evaluations during the assessment period:~        -  Complete physical examination.~        -  Laboratory studies of blood, urine, and stool samples.~        -  Radiologic evaluations, including computerized tomography (CT) and magnetic resonance~          imaging (MRI) scans for all participants and mammograms for females.~        -  Cardiac evaluation, vascular studies, and pulmonary studies to measure heart and lung~          function, and digestive tests to measure stomach and intestinal function.~        -  Neurocognitive testing to measure brain function.~        -  Optional skin biopsy.~        -  Participants will be asked to complete questionnaires assessing current quality of life~          and daily living skills.~   "
201573|NCT00924118|"~     The purpose of this study is to determine whether the intravenous infusion of sodium nitrite~     safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction~     resulting in improved left ventricular function.~   "
201574|NCT00924105|"~     The purpose of this clinical trial is to test safety and tolerability of a vaccine targeting~     Interleukin-1 beta in patients with type 2 diabetes.~   "
201582|NCT00924001|"~     Background:~        -  This study will use cells called DMF5 to treat patients with metastatic melanoma~          (melanoma that has spread beyond the primary tumor site).~        -  The DMF5 cells were first obtained from a tumor of a patient with melanoma with HLA-A201~          tissue type. The tumor cells were grown in the laboratory, and when the laboratory-grown~          cells were given back to the patient, the patient's tumors shrank dramatically. In~          laboratory tests, DMF5 cells were also shown to shrink mouse melanoma tumors.~      Objectives:~      -To determine whether preparatory chemotherapy followed by infusion of DMF5 cells is a safe~     and effective for shrinking melanoma tumors.~      Eligibility:~      -Patients with metastatic melanoma and tissue type HLA-A201 who are 18 years of age or older.~      Design:~        -  Patients have a preparatory regimen of chemotherapy with cyclophosphamide and~          fludarabine followed by infusion of DMF5 cells and then high-dose interleukin. The~          chemotherapy, interleukin and cells are given intravenously (through a vein).~        -  Patients have frequent blood tests to look for the side effects and response to~          treatment.~        -  Patients may be asked to have a tumor biopsy (surgical removal of a small piece of tumor~          tissue) to examine the effects of treatment on the immune cells in the tumor.~        -  Patients have a physical examination, computed tomography (CT) of the chest, abdomen and~          pelvis and laboratory tests 4 to 6 weeks after treatment and then monthly to evaluate~          the tumor.~        -  The first group of patients participates in the Phase I portion of the study, called the~          dose escalation phase. This phase will determine the highest safe dose of DMF5 cells.~          There will be three dose levels of DMF5 cells, with the first patients enrolled getting~          the smallest dose and then increasing the dose when the preceding level has been shown~          to be safe.~        -  Patients in the Phase II portion of the study receive DMF5 cells at the highest dose~          found to be safe in Phase I, to test the effectiveness of the treatment.~   "
201694|NCT00922415|"~     our primary objective is to correlate fecal calprotectin with currently used Crohn's disease~     endoscopic disease activity scores used for predicting endoscopic recurrence. Our secondary~     objectives will be to determine a cutoff for early macroscopic recurrence of disease based on~     surveillance colonoscopies , and to compare this with other surrogate markers .~   "
201575|NCT00924092|"~     Objectives:~        -  To find out the maximum tolerated dose of the GI-6207 vaccine (the highest dose that~          does not cause unacceptable side effects), and to evaluate any side effects.~        -  To see if GI-6207 has any effect on patients tumors.~        -  To learn how the vaccine causes immune responses against the cancer.~      Eligibility:~        -  Patients 18 years of age and older who have been diagnosed with a cancer that has not~          responded to standard treatments. Patients must not be allergic to yeast or yeast~          products.~      Design:~        -  Initial physical examination, blood and tissue sampling, computed tomography (CT) scan,~          and skin test to determine eligibility for the procedure.~        -  Treatment with GI-6027 in seven 14-day cycles as follows:~        -  Vaccine administered on days 1, 15, 29, 43, 57, 71, and 85.~        -  Vaccine given at four sites around the body: right and left chest area below the armpit,~          and right and left upper thigh in the pelvic region. (These areas drain into parts of~          your body that contain large numbers of lymph nodes. The lymph nodes contain immune~          cells that may be activated by the vaccine to target cancer cells.)~        -  Clinic visits for physical examinations to check vital signs, take additional blood and~          urine samples, and perform other tests needed for the study.~        -  After day 85 (about 3 months), patients will continue to receive vaccine monthly (or~          every 28 days) as long as the vaccine is not producing harmful effects or side effects~          and the cancer is either stable or reducing. Patients who do well on the vaccine may~          continue to receive it for as long as it is available.~   "
201576|NCT00924079|"~     The purpose of this study is to investigate possible responses to pharmacokinetic properties~     for nalbuphine oral formulations in healthy volunteers.~   "
201577|NCT00924066|"~     Background:~        -  Ixabepilone is a member of the class of drugs called epothilones. These drugs interfere~          with the ability of cancer cells to replicate.~        -  Epothilones are similar to taxanes, another class of drugs, which includes the drug~          Taxol. Taxol is widely used to treat a variety of cancers.~        -  Ixabepilone can work in cells that are resistant to Taxol.~      Objectives:~        -  To determine whether ixabepilone is effective for treating cervical cancer.~      Eligibility:~        -  Women 18 years of age or older with cervical cancer.~      Design:~        -  Patients receive ixabepilone intravenously (through a vein) over 60 minutes on the first~          5 days of each 21-day treatment cycle. Their dosage may be adjusted according to how~          their bodies respond to the drug.~        -  The number of cycles each woman receives depends on her response to the treatment.~        -  Patients have CT (computed tomography) scans and other tests before starting treatment~          and then every other treatment cycle to determine the response of the tumor to~          ixabepilone.~        -  Patients who can undergo a tumor biopsy (surgical removal of a sample of tumor tissue)~          are asked to have a biopsy done before starting treatment with ixabepilone and again on~          the fourth or fifth day of treatment. This procedure is optional.~   "
201578|NCT00924053|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how~     much of the drug gets into the blood and how long it takes the body to get rid of it) of~     single doses of EGT0001474 given to patients with Type 2 diabetes. The study will also~     evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.~   "
201579|NCT00924040|"~     BL22 is a type of protein that scientists have created to interact with certain cancer cells.~     Experiments have shown that BL22 can bind with cancer cells that have a particular kind of~     protein (called CD22 ) on their surface, and can kill those cells. CD22 is present on certain~     types of hairy cell leukemia (HCL) cancer cells, and researchers have been working on~     treatments that will use BL22 and other related proteins to interact with and kill these~     kinds of cancer cells. The primary purpose of this study will be to provide access to and~     treatment with BL22 for patients who have HCL in order to determine their response to the~     treatment. In addition, the study will assess potential side effects of BL22 and examine why~     some patients respond better than others to treatment with BL22 and related therapies.~      This study will include about 21 to 25 adults who have been diagnosed with forms of HCL that~     have not responded well to standard treatments such as surgery, chemotherapy, or radiation~     therapy. These adults also will have received anti-CD22 therapies before, potentially~     including treatments with BL22, and have not developed immunity or resistance to these~     treatments.~      Prior to the study, patients will undergo a 1- to 2-week screening period to assess their~     eligibility for treatment. Eligible patients will participate in the study for up to 16~     cycles of treatment, with each cycle lasting approximately 4 weeks. For each cycle, patients~     will receive 1 prescribed dose of BL22 every other day for a total of 3 doses per cycle, and~     will be assessed after every cycle to evaluate the success of the treatment. During the~     evaluation visits, patients will be required to have a brief physical examination, give blood~     and urine samples for testing, and undergo other tests as need to check heart and kidney~     function and assess the state of the leukemia. Patients who agree will give additional blood,~     urine, or bone marrow samples for future research purposes.~   "
201580|NCT00924027|"~     Background:~        -  One standard way of giving radiation is to combine external beam treatments with~          internal brachytherapy treatments, which involve short-range radiation therapy that~          gives a high dose of radiation directly to a cancer or to the area where cancer cells~          were removed.~        -  Brachytherapy is done by placing hollow implant device(s) into the area to be treated~          and then moving a radiation source into each. The type of device depends on the type of~          cancer and the site to be treated. These devices can range from hollow applicators and~          needles to balloon-like equipment.~      Objectives:~        -  To evaluate the quality of the brachytherapy procedure at the National Institutes of~          Health s Radiation Oncology Branch.~      Eligibility:~        -  Patients with cancer who could potentially benefit from high-dose brachytherapy as part~          of their treatment.~      Design:~        -  In conjunction with their existing treatment, patients will be treated with high-dose~          brachytherapy as determined appropriate for their particular type of cancer and cancer~          history.~        -  Each treatment will take place in the Radiation Oncology Clinic.~        -  If the patient does not have implant devices, the clinic staff will insert them and~          check their placement through a computed tomography (CT) scan.~        -  The calculations to determine the appropriate brachytherapy dose will take a few hours;~          the brachytherapy treatment itself will take between 10 and 30 minutes.~        -  The number of brachytherapy treatments will vary according to the individual needs and~          requirements of each type of cancer and each patient.~        -  Patients will return to the Radiation Oncology Clinic for followup visits at 1, 3, 6, 9,~          and 12 months after the completion of radiation therapy. Followup evaluations will~          include a medical history and physical examination, assessment of any side effects of~          radiation therapy, and a repeat of any imaging (i.e., CT, MRI, X-ray) that was done at~          baseline to evaluate the tumor response.~   "
201581|NCT00924014|"~     The purpose of the study is to compare the effects of conivaptan and diuretics on renal blood~     flow and neurohormones.~   "
201583|NCT00923988|"~     Passive smoking is associated with an increased risk for cardiovascular events. However, the~     exact mechanisms by which passive smoking affects cardiovascular health are not entirely~     understood. In the present study, the researchers investigate the effects of short-term~     exposure to secondhand smoke on platelet function and peripheral microvascular endothelial~     function in healthy individuals. For this purpose, platelet function and endothelial function~     are measured before and after a 1-hour exposure to secondhand smoke in a concentration that~     is encountered in bars and restaurants without smoke-free policies. The researchers'~     hypothesis is that short-term exposure leads to platelet activation and impairment of~     endothelial function.~   "
201695|NCT00922402|"~     The main purpose of this study is to validate an intensive protocol of insulin infusion and~     subsequent subcutaneous insulin administration with the support of continuous glucose~     monitoring, in addition to reference finger-stick values.~   "
201585|NCT00923962|"~     GLP-1 is an incretin hormone which is discharged from the intestines after food intake. The~     hormone is known for its powerful insulinotropic and trophic effects on the beta cells in the~     pancreas and is currently used as an anti-diabetic agent in patients with type 2 diabetes~     (T2DM).~      GLP-1 receptors are widely distributed including on the endothelial cells in both coronary~     and skeletal muscle circulation and on the myocardium. GLP-1-receptor studies on knock-out~     mice have shown that they exhibit a reduced myocardial contractility and reduced diastolic~     heart function. GLP-1 also shows beneficial cardiovascular effects in patients with acute~     myocardial infarctions and dogs with dilated cardiomyopathy in that the left ventricle~     function and endothelial dysfunction improves after GLP-1 treatment via insulin-independent~     mechanisms. Preclinical studies indicate that exogenous administrated GLP-1 in physiological~     concentrations can improve perfusion but this has never been tested in humans. It is also~     unknown whether GLP-1 can directly increase the glucose/metabolite uptake across both cardiac~     and skeletal muscle in an insulin independent manner. Unpublished studies do however indicate~     that the improvement in the cardiovascular system is largely dependent upon a high blood~     glucose level and only partially dependent upon the antiglycemic effects of GLP-1.~      In the proposed studies the investigators wish to examine the physiological role of GLP-1~     receptor stimulation both with regard to perfusion, metabolic improvement as well as cardiac~     inotropic. These studies will be conducted in both healthy and in T2DM patients.~   "
201586|NCT00923949|"~     Background:~        -  Pioglitazone is a drug that belongs to the class of antidiabetic agents called~          thiazolidinediones. It is approved for treatment of type 2 diabetes mellitus.~        -  Research suggests that the thiazolidinediones may have anticancer activity that can~          reduce cancer risk or cause tumors to shrink.~      Objectives:~      -To test how a pioglitazone works as a treatment of Stage IA to IIB Non-Small Cell Lung~     Cancer (NSCLC) and to look at the effect of the drug on cancer cells.~      Eligibility:~      -Patients 18 years of age or older who will undergo surgery for Stage IA to IIB non-small~     cell lung cancer (NSCLC).~      Design:~      -The study includes a screening visit to determine eligibility, treatment with pioglitazone,~     a follow-up visit after 2 to 3 weeks of treatment and a post-surgery visit. Procedures~     include:~        1. Medical history, physical examination, blood tests, electrocardiogram~        2. Bronchoscopy to obtain cancer cells. This is done before pioglitazone treatment begins~          and again during lung surgery. Some patients may also require mediastinoscopy or biopsy~          to collect cells.~        3. Treatment with pioglitazone tablets once a day for at least 2 weeks and no more than 6~          weeks, depending on when surgery has been scheduled.~        4. Positron emission tomography (PET) scan before starting pioglitazone treatment. National~          Cancer Institute (NCI) patients also have a follow-up PET scan after treatment but~          before surgery.~   "
201587|NCT00923936|"~     Background:~        -  The drug liposomal doxorubicin is approved by the U.S. Food and Drug Administration~          (FDA) for the treatment of Kaposi's sarcoma (KS). A second drug, bevacizumab, is a~          biologic agent (such as antibodies, interleukins, and vaccines) that stops abnormal~          blood supply to tumors. Bevacizumab is approved by the FDA, in combination with other~          drugs, for the treatment of breast cancer, colon cancer, and lung cancer.~        -  Researchers are now studying the combination of liposomal doxorubicin with bevacizumab~          as a novel approach to the treatment of advanced KS. Researches will be measuring KS~          tumor responses to this combination to determine whether the drugs might have anti-KS~          activity.~      Objectives:~        -  To estimate the overall response rate (ORR) of six cycles of liposomal doxorubicin~          combined with bevacizumab in patients with advanced KS.~        -  To evaluate the safety of the regimen and to estimate the complete response rate after~          six cycles, the median number of cycles needed to obtain a partial response, and the~          12-month progression-free survival.~      Eligibility:~        -  Patients 18 years or older with relatively severe acquired immune deficiency syndrome~          (AIDS)-related KS or patients with KS unrelated to AIDS or human immunodeficiency virus~          (HIV) infection, whose KS that can be evaluated for potential response to therapy and~          meet a number of other criteria.~        -  Women who are pregnant or breastfeeding are not eligible.~        -  Other ineligibility criteria include surgery within 4 weeks, chemotherapy within 3~          weeks, heart disease, hemoptysis (coughing up blood), or gastrointestinal bleeding.~      Design:~        -  Researchers will conduct the following tests before the start of the study:~        -  Physical examination and a detailed medical history.~        -  A biopsy.~        -  Blood and urine tests.~        -  Treatment will include two phases, an induction phase and a maintenance phase:~        -  Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later~          by liposomal doxorubicin mg/m2 and bevacizumab every 3 weeks for six cycles.~      Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.~        -  Monitoring will include a review of side effects, physical exam (including blood~          pressure), and blood and urine samples; following the induction phase, the patient will~          receive a multi gated acquisition scan and electrocardiography (EKG) to record~          electrical activity in the heart.~        -  Research tests include blood and saliva samples, additional biopsies (optional), and~          noninvasive imaging.~        -  Treatment is stopped if any of the following occur: completion of 1 year of therapy,~          progressive KS, patient preference, or unacceptable toxicity.~        -  Post-treatment evaluations include clinic visits every 3 months or as needed up to 2~          years, and blood and saliva samples (for research).~   "
201588|NCT00923923|"~     Method: This study is designed as an accompaniment to an already funded study - a 12-week~     treatment trial with prazosin for patients with PTSD and AD.~      The study design will consist of III phases. In phase I, all subjects will participate in~     three laboratory sessions to determine their reactivity to stress. Stress reactivity will be~     measured using: traumatic experiences, stressful non-trauma experiences and neutral~     experiences, presented randomly. Laboratory sessions will be conducted in an outpatient~     setting. Phase II is a randomized clinical trial evaluating prazosin versus placebo for 12~     weeks in a double-blind, controlled fashion in an outpatient setting. The treatment will last~     for 12 weeks and outcomes will include symptoms of PTSD and alcohol use. In phase III,~     subjects will again participate in a laboratory session. This phase of the study will be~     conducted after at least 6 weeks of treatment while patients are on medication (prazosin or~     placebo).~      Hypotheses:~      Primary: The investigators hypothesize that prazosin will be more effective than placebo in~     reducing trauma-related stress reactivity in a laboratory paradigm, particularly anxiety,~     craving for alcohol, and hormonal response, in individuals with PTSD and AD.~      Secondary: The investigators hypothesize that stress reactivity will have a moderating effect~     on treatment with prazosin, such that individuals with high levels of stress reactivity will~     have fewer heavy drinking days, a significant reduction in PTSD symptoms, and shorter time to~     relapse than individuals with low levels of stress reactivity.~   "
201621|NCT00923403|"~     Hypercholesterolemia is a well-established risk factor for the development of~     atherosclerosis, a component of cardiovascular disease (CVD). The National Cholesterol~     Education Program advises the public to consume 2 g/day of plant sterols or stanols in~     addition to the Therapeutic Lifestyle Change Diet to lower elevated low-density lipoprotein~     (LDL) cholesterol levels. For foods to carry the FDA health claim label they must contain~     0.65 g of phytosterol ester or 1.7 g of phytostanol ester per serving. The study was a~     controlled diet, cross-over clinical investigation using a Latin square sequence. It~     consisted of two 29 d phases separated by a four week wash out interval. Subjects were~     randomized to one of two treatment arms: 1 % dairy milk or low-fat soy beverage providing~     1.95 g plant sterols/day.~   "
201589|NCT00923910|"~     Background:~        -  Most patients with acute lymphoblastic leukemia (ALL) and many patients with acute~          myelogenous leukemia (AML), chronic myelogenous leukemia (CML) and non-Hodgkin's~          lymphoma (NHL) have a protein called Wilm's Tumor 1 (WT1) in their cancer cells. This~          protein is thought to be able to influence the growth of these cancers.~        -  A vaccine made with the WT1 protein may boost the immune system to help fight these~          cancers in patients whose cancer cells contain the protein.~      Objectives:~        -  To determine the safety, effectiveness and side effects of giving the WT1 vaccine and~          donor white blood cells to patients with AML, ALL, CML or NHL who have previously~          received standard treatment and undergone stem cell transplantation.~        -  To determine the immune response to the WT1 vaccine and donor white blood cells in these~          patients and to determine if the response is related to the amount of WT1 protein in the~          patient's cancer cells.~      Eligibility:~        -  Patients between 1 and 75 years of age with the blood antigen human leukocyte antigen~          (HLA-A2) and the WT1 cancer protein who have persistent or recurrent blood cancers after~          stem cell transplantation.~        -  The prior stem cell transplant donor must be willing to provide additional cells, which~          will be used to prepare the cellular vaccines and for donor lymphocyte (white blood~          cell) infusions.~      Design:~        -  Patients are given the WT1 vaccine every 2 weeks for 6 weeks (weeks 0, 2, 4, 6, 8, 10).~          Each vaccination consists of two injections in the upper arm or thigh.~        -  On weeks 0, 4 and 8, patients also receive white blood cells from a donor to enhance the~          immune response. The cells are also given as a 15- to 30-minute infusion through a vein~          about 1 hour after the vaccine injection. Donor infusions are given only to patients~          with mild or no graft-vs-host disease resulting from their prior stem cell~          transplantation.~        -  Periodic physical examinations, blood and urine tests, scans to evaluate disease and~          other tests as needed are done for 12 months after enrollment in the study.~   "
201590|NCT00923897|"~     Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or~     other symptoms related to cancer. This is used commonly for cancer that has spread to the~     bones and brain, and for many other primary cancers that are too advanced to be cured,~     including lung cancer, pancreatic cancer and head and neck cancer. The benefits of palliative~     radiotherapy for advanced liver cancer have not been well studied.~      This study is designed to help to see whether palliative radiation therapy is effective in~     controlling pain, discomfort or other symptoms related to liver cancer, and how this therapy~     Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and~     Hepatic Metastases might affect the quality of life of patients receiving such therapy. This~     information will help the doctors understand if there are specific conditions under which~     radiation therapy is more effective and worthwhile, and how it may affect the quality of life~     for patients who have locally advanced hepatocellular carcinoma and hepatic metastasis.~   "
201591|NCT00923884|"~     Background:~        -  The Lung Cancer section of the National Cancer Institute s Medical Oncology Branch is~          running a study to better understand which genes might be important in patients who are~          undergoing therapy for lung cancer.~      Objectives:~        -  To find out if differences (also called polymorphisms) in specific genes lead to~          differences in outcomes (such as treatment success and survival rates) for patients who~          have been diagnosed with lung cancer.~        -  To establish a repository of genetic information for future studies of these differences~          and their relation to lung cancer.~      Eligibility:~        -  Any individual who has been diagnosed with lung cancer and is being treated through the~          National Cancer Institute.~      Design:~        -  After entrance in this study, patients will provide information to the researchers on~          age, gender, race/ethnicity, treatments received and response to treatments, and other~          specific information about their disease. This information will be kept confidential.~        -  Approximately half a tablespoon of blood will be drawn.~        -  Patients will be treated for lung cancer with normal treatment methods, as if they had~          not been enrolled in the study~        -  Some patients may be offered the option of enrolling in separate research protocols for~          cancer treatment, involving chemotherapy, surgery, or radiation.~   "
201592|NCT00923871|"~     Breast radiation treatment is planned from a Computed Tomography (CT) scan. This study is~     designed to investigate a method to reduce the time between the planning of radiation~     treatment and its actual start by automating the intensity-modulated radiation therapy (IMRT)~     planning process. The investigators plan to examine data from another scan called Cone Beam~     Computed Tomography (CBCT). A CBCT scan provides similar information to a conventional CT~     scan, however the images for CBCT are acquired at the treatment unit (linear accelerator used~     for treatment). Using these x-ray pictures of patients, the study team consisting of a~     radiation oncologist, a medical physicist and a radiation therapist will create a custom~     treatment plan unique to each patient. By doing this, the investigators hope to reduce the~     amount of time spent waiting for treatment and the number of hospital visits for patients in~     the future.~   "
201593|NCT00923858|"~     The purpose of this project is to provide information which can help us understand what~     happens over time to rotator cuff tears. In this study, the investigators will follow a~     population of people with rotator cuff tears that do not hurt (asymptomatic) and to establish~     the probability that an asymptomatic rotator cuff tear, identified in the context of~     contralateral symptoms, will become symptomatic over time. To determine with ultrasound the~     probability that a rotator cuff tear will enlarge over time. To determine if symptom~     progression correlates with enlargement of the rotator cuff tear and/or degenerative changes~     on radiographs. In order to obtain data, study subjects will be recalled for follow-up at 1~     year time points over a 5 year period. The study subjects will have repeat physical exam,~     ultrasound and radiographic examinations. A control group of normal patients will also be~     followed for comparison.~   "
201594|NCT00923845|"~     Background:~      Low-dose chemotherapy is easier for the body to tolerate than typical high-dose chemotherapy~     and involves a shorter period of complete immune suppression.~      Donor immune cells called lymphocytes, or T cells, fight residual tumor cells that might have~     remained in the recipients body after stem cell transplant, in what is called a~     graft-versus-tumor (GVT) effect.~      The immune-suppressing drug sirolimus appears to help prevent graft-versus-host disease~     (GVHD), a side effect of stem cell transplant in which donated T cells sometimes attack~     healthy tissues, damaging organs such as the liver, intestines and skin.~      Th2 cells are cells collected from the transplant donor and grown in a high concentration of~     sirolimus.~      Objectives:~      To determine whether stem cell transplantation using low-dose chemotherapy and~     sirolimus-generated Th2 cells can cause a remission of advanced kidney cancer.~      Eligibility:~      Patients between 18 and 75 years of age who have kidney cancer that has spread beyond the~     kidney and who have a tissue-matched sibling stem cell donor.~      Design:~      Patients undergo stem cell transplantation as follows:~        -  Low-intensity chemotherapy with pentostatin and cyclophosphamide over a 21-day period to~          reduce the level of the immune system to prepare for the transplant. Pentostatin is~          given through a vein (intravenous (IV)) on days 1, 8 and 15; cyclophosphamide tablets~          are taken by mouth for 21 consecutive days.~        -  Sirolimus tablets, taken by mouth, starting 2 days before the transplant and continuing~          until 60 days after the transplant.~        -  IV infusions of stem cells and Th2 cells.~      Following the transplant, patients have the following procedures:~        -  Additional Th2 cell infusions on days 14 and 45 after the transplant.~        -  Follow-up visits at the National Institutes of Health (NIH) Clinical Center twice a week~          for the first 6 months after the transplant and then less frequently for at least 5~          years to evaluate response to treatment and treatment side effects. Evaluations include~          a bone marrow aspirate and biopsy 1 month after transplant and periodic blood tests and~          imaging procedures (e.g., computed tomography (CT) or magnetic resonance imaging (MRI)~          scans).~   "
201649|NCT00923000|"~     The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and~     morphine with traditional Chinese herbs in healthy volunteers.~   "
201595|NCT00923832|"~     Background:~        -  Fungal infections of the lung (pneumonia) can be caused by molds, such as Aspergillus~          and Zygomycetes, but these causes are often difficult for a doctor to diagnose. Early~          and accurate diagnosis of these infections can help doctors to select the correct~          medicines for proper treatment.~        -  A number of methods are used to diagnose fungal pneumonia. Ones that are commonly used~          in clinical practice include radiographic imaging (chest X-rays and computed tomography~          (CT) scans), blood tests, and cultures taken from fluid from the lungs (broncho-alveolar~          lavage (BAL) fluid). Other new methods may improve the diagnosis of fungal pneumonias.~          These methods include tests that can detect DNA from the fungal germ in blood and BAL~          fluid of some patients with these infections.~      Objectives:~        -  To help develop better and more accurate methods of diagnosing fungal lung infections.~        -  To detect fungal DNA and chemicals in the bloodstream and BAL fluid of immunocompromised~          patients with pneumonia.~      Eligibility:~      - Immunocompromised patients who are currently enrolled in another NIH protocol and who have~     a CT scan that shows a possible fungal infection of the lung.~      Design:~        -  Researchers will review patients' existing medical records and CT scans, and current~          pneumonia treatment plans.~        -  Patients will provide blood and BAL samples for the duration of their treatment for~          pneumonia, as required by researchers. Additional CT scans will not be performed, except~          as part of existing treatment plans.~   "
201596|NCT00923819|"~     The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity~     is to determine whether surgical treatment gives more health benefits than standard~     conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a~     low complication rate.~   "
201597|NCT00923806|"~     Background:~        -  Carcinoembryonic antigen (CEA) is a protein present mostly in cancer cells.~        -  An experimental procedure developed for treating patients with cancer uses blood cells~          found in their tumors or bloodstream. These cells are genetically modified using the~          anti-CEA gene and a type of virus. The modified cells (anti-CEA cells) are grown in the~          laboratory and then given back to the patient to try to decrease the size of the tumors.~          This is called gene therapy.~      Objectives:~        -  To determine whether advanced cancers that that express the CEA antigen can be treated~          effectively with lymphocytes (white blood cells) that have been genetically engineered~          to contain an anti-CEA protein.~      Eligibility:~        -  Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond~          the original site) and for whom standard treatments are not effective.~        -  Patients' tumors express the CEA antigen.~        -  Patients have the human leukocyte (HLA-A*0201) antigen.~      Design:~        -  Workup with scans, x-rays and other tests.~        -  Leukapheresis to obtain cells for preparing the anti-CEA cells for later infusion.~        -  1 week of chemotherapy to prepare the immune system for receiving the anti-CEA cells.~        -  Infusion of anti-CEA cells, followed by interleukin-2 (IL-2) treatment. The cells are~          given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a~          vein every 8 hours for a maximum of 15 doses.~        -  1-2 weeks of recovery from the effects of chemotherapy and IL-2.~        -  Periodic follow-up clinic visits after hospital discharge for physical examination,~          review of treatment side effects, laboratory tests and scans every 1 to 6 months.~   "
201598|NCT00923793|"~     The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer~     aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to~     infections, re-operations, antibiotic treatment or removal of the implant.~   "
201599|NCT00923780|"~     Background:~        -  Tumors depend on blood vessels to provide the nourishment that allows them to grow.~        -  Thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among the~          tumors that contain the most blood vessels. Thus, endocrine tumors are important for the~          study of new blood vessel formation in tumors.~      Objectives:~      -To obtain tissues from endocrine tumors for examination to determine how they differ from~     normal tissue.~      Eligibility:~      -Patients who are scheduled for surgery to remove an endocrine tumor, those in or around the~     thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue.~      Design:~        -  Tissues will be obtained from patients during surgery to remove thyroid, parathyroid,~          adrenal, pancreas, or neuroendocrine tumors.~        -  About 400 patients will be enrolled in the study over a period of 5 years.~   "
201600|NCT00923741|"~     Background:~      More effective therapies are needed for patients with non-small cell lung cancer (NSCLC)~     whose disease has advanced or spread beyond the original site following standard treatment.~      Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in~     body secretions such as breast milk, tears and saliva.~      In previous studies, talactoferrin improved life span in patients with NSCLC without causing~     toxic side effects.~      Objectives:~      To examine the effects of talactoferrin on the immune system and determine its effectiveness~     in treating NSCLC.~      Eligibility:~      Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse~     following at least one course of treatment.~      Design:~      Talactoferrin treatment: Patients take liquid talactoferrin twice a day for 12 weeks,~     followed by 2 weeks off the drug. Treatment may continue in these 14-week cycles depending on~     the drug side effects and the response of the tumor.~      Evaluations: Patients are evaluated at the clinic with a physical examination, check of vital~     signs and blood tests every 3 weeks.~      CT scans: Patients have CT scans to monitor disease before starting treatment, again at 6~     weeks and 12 weeks and then every 12 weeks during the duration of treatment.~      Apheresis: Quantities of white blood cells called lymphocytes are collected through a~     procedure called apheresis in order to measure the immune response to treatment. In this~     procedure, blood is collected through a needle placed in a vein in the arm (similar to~     donating blood) and circulated through a cell separator machine. The lymphocytes are~     extracted and the rest of the blood is returned to the body through the same needle.~   "
201650|NCT00922987|"~     Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is~     used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce~     seizure frequency.~   "
201711|NCT00922181|"~     Microwave ablation (MWA) is the most recent development in the field of local ablative~     therapies. The aim of this study was to evaluate the variability and reproducibility of~     single-probe MWA versus radiofrequency ablation (RFA) of metastatic liver tumours smaller~     than 3 cm in patients without underlying liver disease.~   "
201601|NCT00923728|"~     Background:~        -  AVN944 is an experimental cancer treatment drug, not yet approved by the U.S. Food and~          Drug Administration. To date, AVN944 as a single drug has been tested in several studies~          involving humans, including healthy volunteers, patients with leukemia, and patients~          with advanced pancreatic cancer.~        -  More research is needed to determine the safety and effectiveness of AVN944.~      Objectives:~        -  To determine the safety of AVN944.~        -  To determine the maximum tolerated dose (the highest dose that does not cause~          unacceptable side effects) of AVN944.~        -  To see if AVN944 has any effect on patients' tumors.~        -  To learn how the body breaks down AVN944.~      Eligibility:~        -  Patients 18 years of age and older who have advanced stage solid tumors for which~          standard therapies do not exist or are no longer effective.~      Design:~        -  Participants will have a screening visit and five clinic visits during the first~          treatment cycle. Additional treatment cycles will involve two clinic visits during each~          28-day cycle. After participation in the study ends, patients will be asked to return~          within 28 days after the last dose of study drug for final study procedures.~        -  Evaluations before the treatment period:~        -  Physical examination, including vital signs and body weight checks, and pregnancy test~          for women who can become pregnant.~        -  Questions about medications and side effects.~        -  Blood and urine tests.~        -  Disease evaluation with CT, chest x-ray, and additional laboratory tests depending on~          the type of cancer.~        -  All patients will have blood samples taken at each visit.~        -  Patients will take specific doses of AVN994 as directed by researchers, and will be~          asked to keep a diary to record their doses and any side effects. They will be monitored~          with frequent blood draws at each study visit to provide information on the safety and~          effectiveness of the drug.~        -  During different cycles, patients will have their disease evaluated by researchers and~          will be asked if they wish to continue taking AVN994 as part of the study.~   "
201602|NCT00923702|"~     The primary study hypothesis is that a two-dose human papillomavirus (HPV) vaccine regimen~     would offer similar immunogenicity and protection as that of a three-dose regimen to girls~     against persistent HPV infection and cervical neoplasia caused by HPV types included in the~     vaccine.~   "
201603|NCT00923676|"~     Hyperlipidemias are frequently associated with and are considered an important cause of~     erectile dysfunction in men. This association has been attributed to the impairment of blood~     flow through endothelium-dependent relaxation in smooth muscle cells of corpus cavernosum.~     Basic science and human research suggest that the vascular pathophysiology of male and female~     sexual dysfunction may be similar, as the first phase of the female sexual response is~     mediated by a combination of vasocongestive and neuro-muscular event which include increased~     clitoral length and diameter, as well as increased vaginal lubrication, wall engorgement and~     luminal diameter. The investigators have shown that women with hyperlipidemia had a higher~     prevalence of sexual dysfunction as compared with age-matched women without hyperlipidemia.~      The aim of this study was to asses the effect of anti-hyperlipidemic drugs (fenofibrate and~     rosuvastatin, single or in combination) on validated indices of sexual function in~     hyperlipidemic men and women with sexual dysfunction at baseline.~   "
201604|NCT00923663|"~     The activity of monotherapy with Lenalidomide will be evaluated in patients with lymphoma of~     the mucosa associated lymphoid tissue (MALT).~   "
201605|NCT00923650|"~     Background:~        -  Informed consent is the process by which prospective participants in clinical trials~          learn about clinical research in order to decide whether they want to enroll in the~          study. It consists of meetings and discussions with the health care team.~        -  Phase I clinical trials are designed to determine what dose of an investigational agent~          is safe to administer to patients.~      Objectives:~        -  To study communication, comprehension and decision-making during the informed consent~          process.~        -  To examine ethical, psychological, social, and educational issues regarding informed~          consent.~        -  To help researchers understand how to improve informed consent and education about~          clinical research.~      Eligibility:~        -  Parents or guardians of children with cancer who are being considered for participation~          in phase I clinical trials~        -  Prospective patients for pediatric phase I clinical trials who are between 14 and 21~          years of age.~        -  Members of the research team who obtain consent from patients and families for pediatric~          phase I clinical trials~      Design:~        -  Research assistants observe and record the informed consent conference held with the~          research team and the parents and children.~        -  After the conference, the research assistant interviews the parents in a private area~          about their experience during the conference and their decision-making process. They are~          asked about their thoughts and opinions during the informed consent conference,~          including the decision-making process, communication and trust in the medical team.~        -  With their parent's permission, patients are interviewed privately to discuss their~          experience during the informed consent conference.~        -  After parents and patients have made their decision about participation in the study,~          they are interviewed again about how they made the decision, aspects of the~          communication during the conference, and how they feel about the doctor. This interview~          is also recorded.~        -  Parents may be contacted 6 months to 2 years from the time of their participation to be~          part of a parent advisory group about the informed consent process.~   "
201606|NCT00923637|"~     The main purpose of this phase II trial is to evaluate the clinical feasibility-in terms of~     patients without dose limiting toxicities or premature treatment withdrawal or death-of~     administering adjuvant chemotherapy of pemetrexed followed by pemetrexed/oxaliplatin~     immediately post-video-assisted thoracic surgery (VATS) in patients with completely resected~     Non-Small Cell Lung Cancer (NSCLC).~   "
201607|NCT00923624|"~     The purpose of this study is to conduct a randomized control trial of a behavioral~     intervention delivered by nurses via an electronic medical record (EMR) patient web portal to~     determine if this is an efficacious method for supporting medication adherence.~   "
201608|NCT00923611|"~     The purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8~     week treatment with Fimasartan (BR-A-657-K) 20, 60, 120, 240 mg and placebo in patients with~     mild to moderate essential hypertension and to determine the adequate antihypertensive dosage~     for later clinical study.~   "
201609|NCT00923598|"~     This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing~     bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one~     of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The~     contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%.~     The basal rate and patient-controlled bolus volume will depend upon the treatment group, but~     the total dose of local anesthetic is the same for each. For the duration of the study, all~     patients will receive the current usual and customary analgesics for bilateral TKA patients.~     All patients will receive a ropivacaine perineural infusions initiated in the operating room~     and continued until at least the afternoon of postoperative day (POD) 2, as well as oral~     acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of~     administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with~     0 equal to no pain and 10 being the worst imaginable pain.~   "
201610|NCT00923572|"~     The objective of this Post Marketing Surveillance (PMS) is to gain information about safety~     and efficacy in real practice.~   "
201611|NCT00923559|"~     Mother-infant relationship disturbances broadly comprise three areas; maternal distress,~     infant functional problems, and relationship difficulties. Given the high frequency of such~     disturbances and the relative paucity of randomized treatment studies, substantial systematic~     investigation is needed. This project is a randomized controlled study comparing~     mother-infant psychoanalytic treatment with treatment as usual in cases where mothers and/or~     health visitors demanded expert help.~   "
201612|NCT00923533|"~     To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.~   "
201712|NCT00922168|"~     The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered~     breathing in cardiac surgery patients.~   "
201613|NCT00923520|"~     Background:~        -  Dimethane sulfonate (DMS612) is an investigational drug that is being administered to~          humans for the first time in people with advanced tumors. More information on the~          maximum tolerated dose of DMS612 will help researchers identify whether the drug is~          suitable for use in treating certain kinds of cancer, particularly renal cell carcinoma.~      Objectives:~        -  To determine the maximum tolerated dose of DMS612 (the highest dose that does not cause~          unacceptable side effects) and evaluate any side effects.~        -  To see if DMS612 has any effect on patients tumors through blood tests and laboratory~          studies.~        -  To learn how the body processes DMS612.~      Eligibility:~        -  Patients 18 years of age and older who have been diagnosed with cancer that has not~          responded well to standard treatments.~      Design:~        -  Pre-treatment evaluation visit to determine eligibility:~        -  Physical examination~        -  Blood and urine tests~        -  Chest X-ray; electrocardiogram; CAT scan of chest, abdomen, pelvis, and other areas of~          the body if needed~        -  Other possible tests, such as magnetic resonance imaging (MRI) or positron emission~          tomography (PET)~        -  Patients will receive one dose of DMS612 by intravenous infusion once a week for 3~          weeks, followed by 1 week without the drug. Doses will be adjusted based on possible~          side effects and cancer response. The disease will be evaluated after three cycles of~          the drug.~        -  Evaluations during the treatment period:~        -  Physical examination and reviews of side effects.~        -  Blood draws to evaluate the effectiveness of the drug, and how it is processed by the~          body.~        -  CAT scan at the end of every two cycles (every 8 weeks).~        -  Other scans and imaging procedures as required by the study doctors.~   "
201614|NCT00923507|"~     Background:~      The development of new technologies now allow scientists to investigate the molecular basis~     and clinical manifestations of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic~     leukemia(CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom~     macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). Applying these methods in~     a natural history study can clarify processes involved in disease progression and possibly~     lead to the discovery or validation of treatment targets.~        -  Objectives:~             -  Study the biology and natural history of MBL/CLL/SLL in patients prior to the time~               when their disease requires treatment and the biology of LPL/WM and SMZL.~             -  Characterize clinical, biologic and molecular events of disease stability and~               progression of patients enrolled on this protocol.~        -  Eligibility:~             -  Diagnosis of MBL/CLL/SLL/LPL/WM/SMZL~             -  Age greater than or equal to 18 years.~             -  Patients with CLL/SLL must not have received previous cytotoxic, monoclonal~               antibody, or kinase inhibitor therapy.~             -  Patients with LPL/WM or SMZL can have prior therapy.~             -  ECOG performance status of 0-2.~        -  Design:~             -  Patients are typically followed every 6 to 24 months in the clinic and have blood~               drawn. When required patients may undergo additional testing that may include bone~               marrow biopsy and aspiration, blood drawing, lymph node biopsy, x-ray studies,~               positron emission tomography and CT and MRI scans. Some of these tests may be~               required to monitor CLL/SLL, LPL/WM, and SMZL patients. Other tests, such as bone~               marrow biopsy and aspiration, lymph node biopsy, may not be clinically indicated,~               but patients may be asked to undergo these procedures for research purposes)~             -  Clinical information is collected and stored in a central databank.~             -  Patients whose cancer requires treatment will be taken off the study and treatment~               options will be discussed with them. If no NIH treatment protocols are available to~               them, they will be returned to the care of their local physician.~   "
201615|NCT00923494|"~     This research study is being done in order to find out if there is any difference in the~     effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be~     achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). The~     investigators want to show if you can have a successful nerve block with less amount of local~     anesthetic, thus potentially decreasing the risk of side effects.~   "
201616|NCT00923481|"~     Background:~        -  The drug R935788 (fostamatanib disodium) is a kinase inhibitor (i.e., it interferes with~          cell communication and growth and may prevent tumor growth).~        -  R935788 has shown promising activity in NCI-60 (a panel of 60 diverse human cancer cell~          lines) against colon cancer, non-small cell lung cancer, and renal cell carcinoma cell~          lines, as well as in two renal cell xenograft models.~        -  This is an open-label, Phase II study of R935788. Phase I studies in patients with~          immune thrombocytopenic purpura, rheumatoid arthritis, and lymphoma have demonstrated~          safety with a continuous dosing schedule, and a maximum tolerated dose has been~          established.~      Objectives:~        -  To test an experimental drug called R935788 (fostamatinib disodium) for its ability to~          stop cancer growth signals, thus slowing the growth of cancer cells in laboratory~          testing.~        -  To determine the clinical response of R935788 administered orally twice a day on a~          continuous schedule in patients with colorectal carcinoma, pheochromocytoma, follicular~          or papillary thyroid cancer, non-small cell lung cancer, hepatocellular, carcinoma of~          the head and neck, and renal cell carcinoma.~        -  To evaluate the effects, safety, and biochemical response of R935788 therapy.~      Eligibility:~        -  Patients with colorectal carcinoma, pheochromocytoma, follicular or papillary thyroid~          cancer, non-small cell lung cancer (excluding squamous cell histology), hepatocellular~          cancer, carcinoma of the head and neck, and renal cell carcinoma whose disease has~          progressed after any therapy or who have no acceptable standard treatment options.~        -  Patients must have recovered from toxicities of prior therapies to at least eligibility~          levels.~        -  Patients who have received radiation or chemotherapy within 4 weeks of study enrollment~          are not eligible.~        -  Women who are pregnant or breastfeeding are not eligible.~      Design:~        -  Researchers will conduct the following tests and procedures during the study:~             -  Clinic visits with a physical exam, including vital signs and blood pressure, every~               other week during cycle 1, and once a month starting with cycle 2.~             -  Blood will be drawn weekly during cycle 1, every other week during cycle 2, and~               once a month starting with cycle 3; urine tests will be conducted depending on~               results of blood tests.~             -  Imaging tests, such as computed tomography (CT) scans (a series of x-rays) or~               ultrasound (an examination using sound waves), will be done every 8 weeks while the~               patient is receiving R935788.~        -  R935788 will be administered orally twice a day for 28 days (one cycle). Imaging studies~          will be obtained every two cycles. Patients will fill in a diary to show when they took~          the medication and to note any side effects. The 28-day treatment cycle will be repeated~          as long as the patient is tolerating R935788 and the cancer is either stable or getting~          better.~        -  Researchers will conduct the following additional tests to see how the study is~          affecting the patient:~             -  Other research blood samples will be collected before treatment, at cycle 1 week 3,~               at the beginning of cycle 2, and at 8 weeks.~             -  Optional tumor biopsies will be requested before starting treatment, at cycle 1 day~               28.~             -  Patients with specific lesions or tumors may be asked for an optional tumor biopsy~               on day 8.~   "
201617|NCT00923468|"~     Background:~        -  A pharmacokinetic (PK) study of a new drug involves taking several blood samples over a~          period of time from study participants to determine how the body handles the substance.~          These studies provide critical information about new drugs.~        -  Often, patients or parents of children in drug studies choose not to participate in~          optional PK studies that are part of the study protocol.~        -  A better understanding of why patients or families do or do not agree to participate in~          PK studies may help researchers make it easier for people to participate in them.~      Objectives:~        -  To learn why some people do or do not agree to participate in PK blood sampling studies.~      Eligibility:~        -  Patients 18 years of age and older and parents or guardians of children who are~          participating in a study of a drug that includes the option of participating in PK~          sampling.~      Design:~        -  Participants fill out a 2-page survey asking about why they did or did not participate~          in the study's PK sampling.~   "
201618|NCT00923442|"~     This study will collect tumor samples from people with cancers of the blood, bone marrow, or~     lymph glands for laboratory study of the biology of these conditions. Such studies contribute~     to a better understanding of cancer biology and to the development of new treatments. Planned~     studies include:~        -  Examination of individual cancer cells and to search for differences compared to other~          types of cancer and normal cells~        -  Examination of the chromosomes and genes in cancer cells and to search for differences~          compared to other types of cancer and normal cells~        -  Development of sensitive methods to detect small amounts of cancer that remain after~          treatment~        -  Search for new cancer proteins that might serve as targets for treatment~        -  Investigation of methods to develop cancer vaccines.~      Patients from birth to 75 years of age with acute lymphocytic leukemia, acute myelogenous~     leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, juvenile myelomonocytic~     leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, and other hematologic malignancies may~     be eligible for this study.~      Blood or bone marrow samples will be collected when sampling is required for the patient's~     medical care. Cells from some individuals will be grown in test tubes, establishing cell~     lines or in animals, establishing xenograft models. (A xenograft is transplantation of cells~     of one species to another species.)~   "
201619|NCT00923429|"~     A randomized controlled trial over a 10-week period with a two-year follow-up. The objectives~     were to compare effects of manual therapy in addition to the stay-active concept versus the~     stay-active concept only in low back pain patients recruited from primary health care. 160~     outpatients with acute or subacute low back pain with or without pain radiation into the legs~     (70 women, 90 men, ages 20-55 years) were recruited from a geographically defined area and~     randomly allocated to stay-active care with or without muscle stretching, or to manual~     therapy with or without specific corticosteroid injections in addition to the stay-active~     concept. Pain, disability rating index, and sickness absence measures were used as outcome at~     10-week follow-up and sickness absence was measured at two-year follow-up.~   "
201620|NCT00923416|"~     The goal of this study is to identify any side effects caused by the implanting of markers~     via the rectum. The investigators will also try to determine if any other factors (such as~     the position of the markers) influence the risk of side effects. The study procedures consist~     of two questionnaires:The first will be completed immediately after the marker implantation~     and the second questionnaire will be completed during your radiotherapy planning.~   "
201713|NCT00922155|"~     The purpose of this study is to examine the usefulness of a balloon covered sheath as a guide~     sheath in endobronchial ultrasound guided transbronchial biopsy and bronchial brushing~     cytology for diagnosis of peripheral lung lesions~   "
201622|NCT00923390|"~     Background:~        -  An experimental cancer treatment procedure involves taking a patient s own tumor or~          blood cells, modifying them with a gene that targets proteins on the surface of tumor~          cells, and growing those cells in a laboratory. The modified cells are then given back~          to the patient by intravenous (IV) transfusion, in the hope that the new cells will~          attack and destroy the cancer cells without harming healthy tissue.~        -  This procedure has been used for melanoma patients, and researchers are now attempting~          to use this treatment for patients with renal (kidney) cancer. In the laboratory, this~          attack kills nearly all kidney cancers tested, but not normal tissues. However, the~          effectiveness and possible side effects of this treatment are still being studied.~      Objectives:~        -  To find out if cells modified to target DR4 and TRAIL (two proteins found on the surface~          of many kidney tumors) are effective in treating kidney cancer.~        -  To determine the maximum tolerated dose (the highest dose that does not cause~          unacceptable side effects) of the modified cells.~      Eligibility:~        -  Patients 18 years of age and older with metastatic renal cancer whose disease has not~          responded to standard treatment.~        -  Patients will be divided into two study branches: Arm A for those who will be receiving~          modified cells from their biopsied tumor, and Arm B for those who will be receiving~          their own modified white blood cells.~      Design:~        -  Five-stage treatment process, outpatient for stages 1 and 5 and inpatient for stages 2~          through 4:~        -  Work-up (1 to 2 weeks): Physical examination, heart and lung function tests, imaging~          tests, blood and/or tumor samples taken.~        -  IV chemotherapy (1 week): Cyclophosphamide and fludarabine to prepare for the new cell~          infusion.~        -  IV cell infusion and treatment with IL-2 to support the modified cells (4 days).~        -  Recovery (1 to 2 weeks): Recover from effects of chemotherapy and infusion.~        -  Follow-up (every 1 to 6 months): Return to clinic for physical exam, review of side~          effects, other tests.~        -  Follow-up evaluations will continue to determine the success of the treatment.~        -  Evaluations during the treatment period:~        -  Physical examination, including vital signs and body weight checks, and pregnancy test~          for women who can become pregnant.~        -  Blood and urine tests.~        -  Disease evaluation and monitoring on both inpatient and outpatient basis.~        -  Because researchers do not know the long-term side effects of gene therapy, patients~          will be asked to participate in long-term follow up for up to 15 years. The follow-up~          will involve yearly physical exams and medical history, and blood collection (3, 6 and~          12 months after treatment, and every year after that).~   "
201623|NCT00923377|"~     Background:~        -  Research suggests that breast cancers may arise from a population of stem cells in the~          normal mammary gland that produce clones of cancer cells.~        -  Researchers are now trying to determine what events may initiate the formation of cancer~          cells.~      Objectives:~        -  To look for and describe breast stem cells from normal breast tissue from women who do~          not have breast cancer.~        -  To compare the breast stem cells between women at increased risk for breast cancer and~          women at average risk for breast cancer.~        -  To show a relationship between the number and type of breast stem cells with the density~          (appearance) of the mammogram (breast x-ray).~        -  To make cell cultures (grow cells under controlled conditions) from the breast stem~          cells.~      Eligibility:~      -Women 18 years of age and older who are at average or increased risk for breast cancer.~      Design:~      Participants complete a health history questionnaire, family history questionnaire and risk~     assessment questionnaire.~        -  Participants have a mammogram and breast biopsy (surgical removal of a sample of breast~          tissue).~        -  Women who can become pregnant have a urine pregnancy test....~   "
201624|NCT00923364|"~     Background:~        -  Stem cells are immature blood cells that grow in the bone marrow and produce all of the~          cells needed for normal blood and immunity. Stem cells can be taken from one person~          (donor) and given to another person (recipient) through allogeneic stem cell~          transplantation. Donor stem cells can then replace the recipients stem cells in the bone~          marrow, restoring normal blood production and immunity. Most allogeneic transplants now~          use stem cells collected from the donors blood in a process called peripheral blood stem~          cell transplantation.~        -  Monocytopenia and mycobacterial infection (MonoMAC) is an immunodeficiency disease that~          is characterized by a lack of monocytes, a type of white blood cell, and an increased~          risk of developing mycobacteria infections that may cause tuberculosis.~        -  Allogeneic stem cell transplantation has been used successfully to treat many kinds of~          immune diseases and cancers that develop in blood or immune system cells. Researchers~          have been studying a particular kind of stem cell transplantation that uses lower than~          usual doses of chemotherapy and particular combinations of drugs to improve the results~          of the procedure for patients with blood-related cancers and pre-cancerous conditions.~      Objectives:~        -  To determine the safety and efficacy of reduced-intensity hematopoietic stem cell~          transplants (a particular stem cell transplantation procedure) for treating MonoMAC.~      Eligibility:~        -  Patients 18-60 years of age who have MonoMAC and who have been matched with a suitable~          stem cell donor.~      Design:~        -  Donors and recipients will undergo separate procedures as part of this protocol.~        -  Donors:~        -  National Institutes of Health researchers will take the donor s medical history, perform~          a physical exam, take blood samples, and explain the procedure. Tests will be performed~          to check the donors heart, lung, kidney, and liver function.~        -  Donors will receive injections of a drug called filgrastim (G-CSF), which causes stem~          cells to travel from bone marrow into blood. The G-CSF shots will be given for 5 to 7~          days before the collection procedure.~        -  Donors will undergo apheresis to collect white blood cells and stem cells directly from~          the blood, which can be done as an outpatient procedure. Researchers may consider the~          alternative of directly collecting bone marrow from the donor, which will require an~          overnight hospital stay.~        -  Recipients:~        -  Recipients will receive 3 days of pre-transplant chemotherapy and radiation therapy to~          prepare for the transplant. For 4 days before the transplant, recipients will receive~          the chemotherapy drug fludarabine, followed by a single dose of radiation therapy, and~          will also receive the drugs tacrolimus and sirolimus to prevent the donor cells from~          attacking the recipient s normal tissues.~        -  Recipients will then receive the transplant of donor stem cells and will continue to~          receive tacrolimus and sirolimus for 3 months after the transplant to prevent the donor~          cells from attacking the recipient s normal tissues. Recipients will be discharged from~          the hospital once their condition is stable.~        -  Recipients will visit the NCI clinic regularly for the first 5 months after the~          transplant, and then less often for at least 5 years. Recipients may receive additional~          donor immune cells (donor lymphocyte infusion) after the transplant if the study doctors~          believe they are needed.~   "
201625|NCT00923351|"~     Background:~        -  Pediatric solid tumors (Ewing's sarcoma, rhabdomyosarcoma, and neuroblastoma) are often~          difficult to cure with standard treatment.~        -  Immune therapy using an experimental vaccine made from proteins from the patient's tumor~          cells may boost the body's immune response against the tumor.~        -  The effects of chemotherapy on the immune system can potentially make immunotherapy more~          effective if administered soon after completion of chemotherapy. The addition of~          recombinant human IL-7 (interleukin 7) (rhIL-7 (recombinant human interleukin 7)) may~          make the immunotherapy more effective.~      Objectives:~      -To determine whether immune therapy given after immune suppression can help the body fight~     the tumor and to determine the safety of the treatment.~      Eligibility:~      -Patients with solid tumors, i.e., Ewing's sarcoma, rhabdomyosarcoma or neuroblastoma whose~     disease has recurred after treatment or spread beyond the original site~      Design:~        -  Patients undergo tumor biopsy (removal of a piece of tumor tissue) to collect tumor~          cells for making a vaccine from proteins in the patient's tumor and apheresis (removal~          of a quantity of white blood cells) to collect white cells for re-building the immune~          system after immune therapy. Apheresis is repeated three times during immunotherapy~          (weeks 8, 14 and 20).~        -  After receiving standard chemotherapy for their tumor (and an additional course of~          fludarabine and cyclophosphamide to further suppress immunity if needed) patients~          receive immune therapy in Cohorts A and B. rhIL-7 is given 48 hours before the vaccine,~          as an injection under the skin in an extremity that will not be used for the vaccine in~          patients in Cohort B only. You will be watched closely for 6 hours after the rhIL-7 for~          any signs of reaction. rhIL-7 will be given before vaccine doses #1, #2, #3, and #4. The~          vaccine is given at study weeks 2, 4, 6, 8, 10 and 12. Each vaccine is given as a total~          of six separate rhIL-7 followed by injections: three intradermal (like a (tuberculosis)~          TB test) on one arm or leg and three subcutaneous (like those for insulin injections for~          diabetes). on the other arm or leg. An anesthetic cream may be used to minimize the~          discomfort of injections.~        -  Patients' white cells are returned to them by infusion through a vein on the first day~          of immune therapy.~        -  Imaging studies and immune studies are done at weeks 1, 8 and 20 to determine the~          response to treatment on the tumor and on the immune system.~   "
201626|NCT00923338|"~     This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal~     fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.~   "
201651|NCT00922974|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This randomized phase II/III trial is studying how well image-guided radiosurgery or~     stereotactic body radiation therapy works and compares it to external-beam radiation therapy~     in treating patients with localized spine metastasis. (phase II completed as of 8-30-11)~   "
201652|NCT00922961|"~     25 patients, treated by brachytherapy in a phase II study Mammosite (from 2003 to 2005),~     will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due~     to brachytherapy.~      During this consultation, a blood sample will be taken for analysis ( rate of CD8~     T-Lymphocyte Apoptosis)~   "
201627|NCT00923325|"~     Background:~        -  This study is a companion biology study to NIH protocol 08-C-0080, A Phase II Trial of~          R1507, a Recombinant Human Antibody to the Insulin-Like Growth Factor-1 Receptor for the~          Treatment of Patients with Recurrent or Refractory Ewing s Sarcoma, Osteosarcoma,~          Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.~        -  Analysis of tumor tissue and blood samples from patients with sarcomas who are receiving~          treatment with the experimental drug R1507 may help elucidate the biology of sarcomas~          and how they respond to certain therapies with monoclonal antibodies.~      Objectives:~        -  To study the effect over time of R1507 on the proteins and cells in the blood and tissue~          of patients with sarcoma in order to learn more about how patients respond to the~          treatment and what changes occur in their cells.~        -  To discover possible new treatments for cancer.~      Eligibility:~        -  Participants in NIH protocol 08-C-0080 for the study of R1507 to treat people with~          various sarcomas.~      Design:~        -  Patients who previously agreed as part of protocol 08-C-0800 to have blood sampling for~          pharmacodynamic studies (blood draws to test blood for levels of R1507 and how the body~          affects R1507) will not have any additional blood drawn as part of this study.~        -  Patients who did not previously agree to pharmacodynamic sampling as part of the~          protocol 08-C-0800 will be asked to give 6 blood samples at various time periods during~          the study.~        -  Pathology slides or tissue blocks obtained under protocol 08-C-0800 will be forwarded to~          F. Hoffmann-La Roche laboratories for analysis.~   "
201628|NCT00923312|"~     This is a phase I/IIa open, uncontrolled, international, prospective clinical trial, in an~     out-patient setting, in patients with stage IIIB/IV NSCLC.~      The phase I part of the study consists of a dose escalation phase, in which the recommended~     dose (RD) for the phase IIa part of the study will be established based on the incidence of~     dose-limiting toxicities (DLT). In the phase IIa part of the study, additional patients will~     be included at the RD, to confirm the safety and explore the activity of that dose.~      This study will take place in Switzerland (2 sites) and Germany (11 sites).~   "
201629|NCT00923299|"~     RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab~     together with trastuzumab may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when~     given together with cetuximab and to see how well it works in treating patients with~     metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.~   "
201630|NCT00923273|"~     Background:~      The drug pemetrexed is used to treat non-small cell lung cancer (NSCLC) that does not respond~     to standard therapy or that has recurred after standard therapy; however, only 9 in 100~     patients respond to pemetrexed.~      Sirolimus is a drug that blocks a protein in cells called mammalian target of rapamycin~     (mTOR). In cancer cells, mTOR is active when it should not be, allowing the cells to grow~     uncontrollably. This protein is unusually active in many cases of NSCLC. By blocking the~     activity of mTOR, sirolimus may make the cancer cells more responsive to treatment with~     pemetrexed.~      Objectives:~      To determine if sirolimus in combination with pemetrexed is safe and well tolerated in~     patients with NSCLC.~      To determine the highest safe dose of pemetrexed combined with sirolimus.~      To look at the ability of sirolimus and pemetrexed to fight NSCLC.~      To learn how the body eliminates sirolimus and pemetrexed.~      Eligibility:~      Patients 18 years of age and older with NSCLC whose disease does not respond to standard~     therapy or has recurred after treatment with standard therapy.~      Design:~      Biopsy before treatment starts, if the tumor is easy to reach by bronchoscopy or can be done~     by needle biopsy. This procedure is optional.~      Drug treatment, as follows:~        -  Day 1: Intravenous (through a vein) infusions of pemetrexed. Small groups (3 to 6) of~          patients are given pemetrexed at a certain dose level. If the first group experiences no~          significant side effects, the next group receives a higher dose. This continues in~          succeeding groups for up to five dose levels until the maximum tolerated study dose~          (highest dose that patients can be given safely) is determined.~        -  To lessen the side effects of pemetrexed, patients also receive a Vitamin B12 injection~          every 21 days, folic acid tablets daily, and dexamethasone tablets twice a day the day~          before, the day of, and the day after pemetrexed infusions.~        -  Days 1-21: Sirolimus tablets by mouth.~      Evaluations during the treatment period:~        -  History and physical examinations, blood and urine tests, electrocardiogram.~        -  Disease evaluation with computed tomography (CT), positron emission tomography (PET) or~          magnetic resonance scans (MRI) scans....~   "
201631|NCT00923260|"~     The aim of the present study was to evaluate the additional effect of sudden visceral fat~     reduction by omentectomy on Metabolic Syndrome, acute phase reactants and inflammatory~     mediators in patients with morbid obesity undergoing Laparoscopic Roux-en-Y Gastric Bypass.~   "
201632|NCT00923247|"~     Background:~        -  The combination of anti-cancer drugs vandetanib (given orally) and bortezomib (given~          intravenously) has not been used in humans. However, both drugs have been studied~          separately. Bortezomib has been approved by the U.S. Food and Drug Administration (FDA)~          for treating multiple myeloma and mantle cell lymphoma, while vandetanib is still under~          investigation pending FDA approval.~        -  Both bortezomib and vandetanib are under investigation for use in treating certain kinds~          of cancer. Researchers hope that the combination of these two drugs will be more~          effective than either of them alone.~      Objectives:~        -  To determine if the combination of vandetanib and bortezomib will decrease the amount of~          the cancer and, if it does, to determine how long the response will last.~        -  To determine any side effects that may occur with this combination of treatments.~        -  To determine what doses of each drug are well tolerated and safe when given together.~        -  To study genetic mutations in tumors to better understand how tumors grow and how these~          drugs interact with the tumor.~      Eligibility:~        -  Patients 18 years of age and older with solid tumors that cannot be surgically removed~          and have either recurred or shown further growth. The tumor(s) must be able to be~          evaluated by X-ray, MRI (magnetic resonance imaging), and CT (computerized tomography)~          scanning.~        -  Patients who have been diagnosed with medullary thyroid cancer will participate in Phase~          II of the study.~      Design:~        -  Tumor samples may be taken at the start of the study for research purposes.~        -  Phase I: Patient groups will be treated on an outpatient basis with vandetanib and~          bortezomib, given at increasing doses over four different levels to determine the~          maximum tolerated dose calculated by height and weight:~        -  Doses will be given on Days 1, 4, 8, and 11 for each 28-day cycle.~        -  Two additional levels (Level 1A and Level 1B) may be included in the study, depending on~          side effects at various levels.~        -  Phase II: Patients with medullary thyroid cancer will be divided into two groups, with~          two patients in Group A for every one patient in Group B. No placebo will be involved in~          this study.~        -  Group A: Patients will be treated with vandetanib and bortezomib at the maximally~          tolerated dose of the Phase I study.~        -  Group B: Patients will be treated with bortezomib alone.~        -  A second tumor sample may be taken. In patients with thyroid cancer, the second biopsy~          will be done at the 6-week evaluation (approximately 42 days after beginning). In~          patients with cancer other than thyroid cancer, the second biopsy will be obtained on~          Day 4 of either the first or second cycle, after the bortezomib infusion.~        -  The effects of the drugs will be studied through blood samples and CT scans taken during~          and after various drug cycles.~   "
201633|NCT00923234|"~     The hypothesis of this study is that 5-aza and lenalidomide act synergistically in MDS and~     AML patients with chromosomal abnormalities involving monosomy 5 or del5q. Therefore, this~     phase I study will investigate the maximum tolerated dose (MTD) of lenalidomide in~     combination with a fixed dose of 5-aza in this patient population.~   "
201653|NCT00922948|"~     The purpose of this study is to verify the oncological efficacy and safety of cryoablation~     and radiofrequency ablation for the treatment of small renal tumors.~   "
201654|NCT00922935|"~     Comparison of early and late loading of implants supporting full each prosthesis in upper~     jaw, using the Cresco prosthetic system on Straumann implants. The study hypothesis is that~     there is no difference between the bone loss (or gain) between the groups.~   "
201634|NCT00923221|"~     Background:~        -  It is not fully understood why prostate cancer in some men becomes androgen-independent~          (no longer responds to anti-androgen medication), but genetics likely plays an important~          role.~        -  Genes contain the hereditary information that is passed down from parents to children.~          Although everyone has the same set of genes, individuals can have different forms of the~          same gene.~        -  Differences in genes may explain, at least in part, why some people develop a more~          aggressive form of prostate cancer than others.~      Objectives:~      -To obtain blood samples from patients with prostate cancer to try to identify gene~     differences associated with progression to the androgen independent state.~      Eligibility:~      -All patients participating in NCI prostate cancer protocols.~      Design:~        -  Patients with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.~        -  Blood samples are collected at the initial visit or at follow-up visits.~        -  DNA (genetic material) and white blood cells are extracted from these samples to be used~          for genotyping and establishment of cell lines.~        -  Gene variations are correlated with prostate cancer prognosis and prognostic indicators.~   "
201635|NCT00923195|"~     Background:~        -  Melanoma antigen recognized by T-cells (MART-1) and gp100 are two genes found in~          melanoma cells. An experimental procedure developed for treating patients with advanced~          melanoma uses these genes and a type of virus to make special cells called anti-MART-1~          and anti-gp100 cells, which are designed to destroy the patient's tumor. The cells are~          created in the laboratory using the patient's own tumor cells or blood cells.~        -  The procedure also uses one of two vaccines-the anti-MART-1 peptide or the anti-gp100~          peptide-to stimulate cells in the immune system that may increase the effectiveness of~          the anti-MART-1 and anti-gp100 cells. Both vaccines are made from a virus that is~          modified to carry a copy of the MART-1 gene or gp100 gene. The virus cannot cause~          disease in humans.~      Objectives:~      - To evaluate the safety and effectiveness of anti-MART-1 and anti-gp100 cells and peptide~     vaccines for treating patients with advanced melanoma.~      Eligibility:~      - Patients 18 years of age with metastatic melanoma for whom standard treatments, including~     aldesleukin (IL-2) therapy to boost immune response, have not been effective.~      Design:~        -  Participants have an initial evaluation with complete medical history, as well as scans,~          x-rays, and other tests as directed by researchers. Most of the treatments for this~          study will be given on an inpatient basis.~        -  Before the treatment begins, participants will undergo leukapheresis (removal of~          selected blood cells) to obtain cells for preparing the anti-MART-1 and anti-gp100~          cells, and for later stem cell transplantation.~        -  Preinfusion treatment: 5 days of chemotherapy and 2 days of total-body irradiation to~          prepare the immune system for receiving the anti-MART-1 and anti-gp100 cells.~        -  Infusion of cells, followed by IL-2 treatment to improve immune response. IL-2 is given~          as a 15-minute infusion through a vein every 8 hours for a maximum of 15 doses (over 5~          days).~        -  After the cell infusion, participants will be divided into two groups and will receive~          either the gp100 peptide or MART-1 vaccine, given once a week for 3 weeks. Participants~          will also have stem cell transplantation (from previously collected stem cells) to~          promote cell survival.~        -  Periodic follow-up clinic visits after hospital discharge for physical examination,~          review of treatment side effects, laboratory tests and scans every 1 to 6 months.~   "
201636|NCT00923182|"~     The primary objective of this study is to confirm the safety profile of alemtuzumab 30 mg~     (the US/European Union (EU) approved dose) in Japanese patients with relapsed or refractory~     Chronic Lymphocytic Leukemia (CLL).~   "
201637|NCT00923169|"~     Background:~        -  GC1008 is a genetically engineered antibody designed to block the activity of~          transforming growth factor-beta (TGF-beta). Although TGF-beta has some normal and~          beneficial effects in the body, it is often over-produced in malignant melanoma tumors,~          and it can help the melanoma grow and spread.~        -  Part 1 of this study enrolled 22 subjects with malignant melanoma or kidney cancer to~          determine the highest safe dose of GC1008, which was found to be 15 mg/kg.~        -  Three of 22 patients with malignant melanoma in Part 1 of the study developed skin~          problems, but it is not known if these problems were related to the administration of~          GC1008.~      Objectives:~      -To determine the frequency of adverse skin side effects of GC1008 in patients with malignant~     melanoma.~      Eligibility:~      -Patients 18 years of age and older with malignant melanoma for whom previous treatment was~     not successful.~      Design:~        -  GC1008 is given intravenously (through a vein) at a dose of 15 mg/kg or 10 mg/kg for~          four doses on study days 0, 28, 42 and 56 (one treatment cycle). Patients whose cancer~          responds to GC1008 may receive one or two additional treatment cycles of four doses~          given every two weeks.~        -  Physical exam and vital signs on study days 1, 14, 28, 42, 56, 84 and 140.~        -  Vitals signs on study days 0, 14, 28, 42, 56, 84 and 140.~        -  Frequent blood sample collections for routine safety tests, measurement of blood levels~          of GC1008, analysis for antibodies against GC1008 and for research studies.~        -  CT or MRI scan, bone scan and PET CT scan before treatment and on study day 84 and 140.~        -  Biopsy of apparently normal skin before treatment and again on day 84.~        -  Review of medicines and well being on study days 0, 14, 28, 42, 56, 84, 112 and 140.~        -  Follow-up visits every 3 months for up 2 years for patients who have not received~          additional treatment for their cancer. Evaluations include physical exam, CT or MRI~          scan, PET CT scan, blood tests and possibly tumor biopsies....~   "
201638|NCT00923156|"~     In addition to the blood pressure lowering effects of aliskiren, it may have beneficial~     effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue~     level. An increase of angiotensin II is associated with progression of heart failure.~     Although the use of ACE-inhibitors in heart failure shows clinical benefit, an increase in~     angiotensin II due to an angiotensin II escape phenomenon is not desirable. It is not yet~     known if a direct renin inhibitor can reduce or even prevent the angiotensin II escape~     phenomenon associated with the use of an ACE-inhibitor. Therefore the study tested the~     effects of ramipril, aliskiren and the combination of both on levels of angiotensin II in the~     blood in patients with systolic heart failure~   "
201639|NCT00923130|"~     Background:~        -  Substantial preclinical antitumor synergy supports the exploration of the combination of~          antiangiogenic compounds (including sunitinib and bevacizumab) plus ixabepilone. In~          Vivo, synergistic activity between ixabepilone and bevacizumab has been demonstrated~          using the 151-B human renal carcinoma xenograft model and this synergy compares~          favorably with other antiangiogenic inhibitors (i.e. sunitinib).~        -  Combination therapies of bevacizumab with chemotherapy demonstrated improved benefit~          compared with single-agent cytotoxics in multiple animal models and in humans.~        -  Clinical activity of both compounds used as single agents has been demonstrated in a~          broad spectrum of solid tumors. Bevacizumab and ixabepilone, when used as a single~          agent, have demonstrated substantial activity in renal cell carcinoma.~        -  Phase II studies with bevacizumab and ixabepilone suggest the absence of overlapping~          toxicities.~        -  Development of a well-tolerated and active bevacizumab/ixabepilone combination has the~          potential to further improve the treatment of metastatic renal cell carcinoma (mRCC),~          and could represent a second-line option after sunitinib or sorafenib are no longer of~          benefit or are intolerable.~      Primary Objectives:~        -  Determine the objective response rate of the combination of ixabepilone and bevacizumab~          in patients with relapsed or refractory mRCC.~        -  Determine progression-free survival.~        -  Characterize the toxicity of the combination of ixabepilone and bevacizumab in patients~          with mRCC.~        -  Determine changes in biomarkers and evaluate correlation with clinical outcomes.~      Eligibility:~        -  Pathologic confirmation of renal cell carcinoma (clear cell histology) by the Laboratory~          of Pathology, National Cancer Institute (NCI), or the Medical University of South~          Carolina.~        -  Presence of metastatic renal carcinoma, after progression or intolerance to Vascular~          endothelial growth factor receptor (VEGFR) inhibitors (sunitinib and/or sorafenib).~        -  Adequate organ and bone marrow function.~      Design:~        -  Multi-center, open labeled phase II study~        -  Following a Simon two-stage optimal design, a maximum of 58 patients with metastatic RCC~          will be accrued.~        -  Ixabepilone will be administered daily as a one hour infusion on five successive days~          (daily x 5), every three weeks (one cycle equals 3 weeks or 21 days +/- 5 days).~          Following cycle 6, cycles will be spread out to 4 weeks or 28 days +/- 5 days. The~          starting dose will be a daily dose of 6 mg/m(2)/day, for a total per cycle dose of 30~          mg/m(2).~        -  In addition, 15 mg/kg bevacizumab will be administered intravenously on day 1 of each~          cycle. The first infusion of bevacizumab will be 90 minutes in duration, the second 60~          minutes in duration, and in all subsequent cycles bevacizumab will be infused over 30~          minutes if prior infusions are well tolerated.~   "
201655|NCT00922922|"~     The purpose of this study is to compare the duration and direct cost of pediatric primary~     care visits consisting of medical concerns only, behavioral concerns only, and medical and~     behavioral concerns.~   "
201714|NCT00922142|"~     Hypothesis:~      There is no significant difference in Cesarean patients' perceptions of overall pain~     management satisfaction between methods used for postoperative pain management.~   "
201640|NCT00923117|"~     Background:~      One way tumors are able to grow is by forming new blood vessels that supply them with~     nutrients and oxygen.~      Sunitinib blocks certain proteins on the surface of tumor and blood vessel cells that are~     involved with the formation of new blood vessels.~      Blocking these proteins may prevent the tumor cells or blood vessels from continuing to grow.~      Objectives:~      To determine whether sunitinib can cause tumors to shrink or stabilize in patients with~     recurrent brain cancer.~      Eligibility:~      Patients 18 years of age or older with brain cancer whose disease has worsened after standard~     treatment with surgery, radiation.~      Design:~      Patients take a sunitinib pill once a day in 4-week treatment cycles. Treatment may continue~     as long as the tumor remains stable or decreases in size and the side effects of treatment~     are tolerated.~      Routine blood tests are done every 2 weeks during the first 8 weeks of treatment and then~     every 4 weeks after that.~      Magnetic resonance imaging (MRI) scans are done before starting treatment (at baseline) and~     at the end of every 4-week cycle to monitor tumor growth.~      Positron emission tomography (PET) scans are done at baseline and at the end of the first~     cycle.~      Neurological and physical examinations are done at baseline, at week 2 of treatment and at~     the end of every treatment cycle.~      Health-related quality of life is assessed every 4 weeks.~      Pregnancy tests, electrocardiograms and echocardiograms are repeated as needed.~   "
201641|NCT00923104|"~     Background:~        -  Blister fluid contains many of the same biomarkers (substances that can be used to~          determine the effects of certain kinds of treatments) as blood and urine samples,~          particularly regarding changes in the skin.~        -  The Radiation Oncology Branch and others are conducting research studies that require~          blood and urine samples from healthy volunteers and from patients with cancer. In~          addition to these samples, researchers would like to collect the fluid from blisters to~          examine markers of inflammation in the skin.~      Objectives:~        -  To compare blood, urine, and blister fluid samples of patients with cancer who are~          undergoing radiation therapy to that of volunteers without cancer who will not be~          receiving radiation therapy.~        -  To gather more information about the effects of radiation therapy on the skin and body~          fluids of individuals.~      Eligibility:~        -  Patients 18 years of age and older who will be receiving radiation therapy for either~          breast or prostate cancer.~        -  A separate group of healthy volunteers will also participate in this study.~      Design:~        -  Physical examination and blood samples to determine eligibility for the study.~        -  Blister induction, conducted before the start of radiation treatment, at completion of~          radiotherapy (last day of treatment), and at a visit 12 months after the end of~          radiation treatment.~        -  Blisters will be created through the use of a suction blister device on the hip (for~          patients with prostate cancer) or on the treated breast or location of removed breast~          (for patients with breast cancer).~        -  Blisters will take approximately 30 minutes to form, and fluid will be removed with a~          needle and syringe.~        -  Blood and urine samples will also be collected at this time.~        -  Radiation treatment for breast or prostate cancer will be conducted according to~          standard procedures, or as directed by a separate research protocol.~        -  Evaluations during the treatment period:~        -  Physical examination, including vital signs and body weight checks, and pregnancy test~          for women who can become pregnant.~        -  Blood and urine tests.~        -  Disease evaluation.~        -  Post-treatment evaluations:~        -  Clinic visits at months 1, 3, 6, 9, and 12 after the end of radiation therapy for~          physical examination and disease assessment.~        -  Study will end 1 year after the final radiation treatment, upon the collection of the~          final (third) blister fluid sample.~   "
201642|NCT00923091|"~     This study is to determine the change in blood pressure from the administration of~     Olmesartan/Amlodipine/Hydrochlorothiazide triple combinations compared to dual combinations~     with Olmesartan/Amlodipine.~   "
201643|NCT00923078|"~     The purpose of this study is to determine whether computer-based training of auditory and~     visual processing results in corresponding improvement in brain function in individuals with~     schizophrenia.~   "
201644|NCT00923065|"~     This study provides cancer care through the National Cancer Institute's Medical Oncology~     Branch (MOB) to patients who are not enrolled in an active treatment research protocol.~     Patients receive standard treatments only; no investigational therapies are provided on this~     protocol.~      Patients 18 years of age and older may be eligible for this protocol. Candidates are patients~     for whom an NCI investigator decides that the interests of the patient and the NCI are best~     served by the patient's enrollment in this protocol to receive care and follow-up within the~     MOB. This includes patients in the following categories:~        -  Patients previously enrolled in NCI trials whose participation in this protocol may~          continue to provide researchers important scientific information~        -  Patients who will be eligible for a research protocol within the foreseeable future~        -  Patients whose medical welfare will be seriously compromised by referral back to the~          community, such as patients with a rare or complex disease for which community resources~          are inadequate or unavailable~        -  Terminally ill patients who have received most of their specialized medical care at the~          Clinical Center and for whom humanitarian considerations dictate that they continue to~          receive their medical care at NIH after going off study for the remaining weeks or~          months of life~        -  Patients with cancer or HIV, or people at risk for cancer or HIV for whom cancer~          treatments at the NCI are requested through the MOB consult service~        -  Patients who are participating in a non-treatment NCI research protocol and require~          standard-of-care therapy~        -  Patients with cancer or HIV or people at risk for cancer for whom cancer treatment or~          management at the NCI would add significant value to the institute's cancer training~          program~      Participants receive standard medical care, including periodic routine laboratory tests,~     diagnostic x-rays, and nuclear medicine scans to monitor the course of illness and the~     effects of any treatment.~   "
201645|NCT00923052|"~     Background:~        -  Researchers are trying to learn what causes certain types of cancer to spread to other~          organs in the body (metastasis). Cancer tumors may produce a very small number of~          specific cells (cancer stem cells) that cause the tumors to grow in other organs~          throughout the body.~        -  By examining cancer tumor tissue, normal tissue, blood, bone marrow, and other body~          fluids, researchers may determine whether these samples contain cancer stem cells.~          Cancer stem cells may provide information on whether the cancer will come back or spread~          before other routine x-ray studies or lab tests indicate its presence.~      Objectives:~        -  To acquire a collection of solid organ cancer stem cells for future study.~        -  To analyze solid organ cancer stem cells from various types of cancer on a genetic~          level.~        -  To determine if solid organ cancer stem cells are present in the blood or bone marrow.~      Eligibility:~        -  Patients 16 years of age and older who have solid organ cancer (cancer in the liver,~          colon, rectum, anus, pancreas, stomach, breast, skin, muscles, fat, connective tissue,~          uterus, ovary, cervix, vagina, vulva, or inner lining of the abdomen) or a precancerous~          growth, and who are scheduled to have a biopsy or surgery to remove the cancer as part~          of their treatment.~      Design:~        -  This is a prospective trial designed to procure solid organ cancer stem cells before~          either surgery or biopsy.~        -  All patients registered to this trial will undergo surgery to extirpate their cancer in~          the NCI~        -  Prior to surgery or biopsy, 8 tablespoons of blood will be drawn.~        -  During the surgery or biopsy, a sample of normal tissue will be removed along with the~          cancerous or precancerous tissue. If separate consent is given, samples of bone marrow~          will also be taken.~        -  After discharge, patients will return to the clinic for routine visits every month for~          the first 3 months following surgery, and then about every 3 months for 2 years, and~          then every 6 months for 3 years. During the visits, patients will have routine blood and~          imaging studies done, and researchers will take additional blood samples (about 8~          tablespoons at each visit) and optional bone marrow samples (4 teaspoons every 6 months)~          to be used for research.~   "
201646|NCT00923039|"~     Small body size at birth, slow weight gain during infancy and increase in body mass index~     after 2 years are independent risk factors for cardiovascular disease and the metabolic~     syndrome. There is a large gap in our understanding of how early growth affects the~     cardiovascular system. Possible mechanisms include alterations in body composition, in~     cardiac structure, in vascular function, in renal function and epigenetic processes.~      The Objective is to determine how size at birth and growth during infancy and childhood~     affect: body composition, cardiac structure and function, vascular and endothelial function,~     renal function, metabolic status and transcriptional and epigenetic characteristics.~   "
201647|NCT00923026|"~     Background:~      The NCI Surgery Branch has developed experimental therapies that involve taking white blood~     cells from patients' tumor or from their blood, growing them in the laboratory in large~     numbers, and then giving the cells back to the patient.~      Objective:~      This study will allow patients to be followed for up to 15 years following treatment on an~     NCI Surgery Branch Gene Therapy Trial as required by the FDA.~      Eligibility:~      Patients must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol~      Design~      Patients will be followed with a physical examination and blood tests for up to 15 years as~     required by the FDA~   "
201648|NCT00923013|"~     Background:~      Hairy cell leukemia (HCL) is highly responsive to but not curable by cladribine (CdA). HCL~     responds to rituximab, which is not yet standard therapy for HCL.~      Patients with the CD25-negative variant (HCLv) respond poorly to initial cladribine but do~     respond to rituximab in anecdotal reports.~      Deoxycytidine kinase phosphorylates cladribine to CdATP, which incorporates into DNA, leading~     to DNA strand breaks and inhibition of DNA synthesis. Rituximab is an anti-CD20 monoclonal~     antibody which induces apoptosis and either complement or antibody dependent cytotoxicity~     (ADCC or CDC).~      Patients in complete remission (CR) to cladribine have minimal residual disease (MRD) by~     immunohistochemistry of the bone marrow biopsy (BMBx IHC), a risk for early relapse. Tests~     for HCL MRD in blood or marrow include flow cytometry (FACS) or PCR using consensus primers.~     The most sensitive HCL MRD test is real-time quantitative PCR using sequence-specific primers~     (RQ-PCR).~      In studies with limited follow-up, MRD detected by tests other than RQ-PCR can be eliminated~     by rituximab after cladribine in greater than 90 percent of patients, but MRD rates after~     cladribine alone are unknown. Simultaneous cladribine and rituximab might be superior or~     inferior to delaying rituximab until detection of MRD.~      Only 4 HCL-specific trials are listed on Cancer.gov: a phase II trial of cladribine followed~     4 weeks later by 8 weekly doses of rituximab, and phase I-II trials of recombinant~     immunotoxins targeting CD22 (BL22, HA22) and CD25 (LMB-2).~      Objectives:~      Primary:~      To determine if HCL MRD differs at 6 months after cladribine with or without rituximab~     administered concurrently with cladribine.~      Secondary:~        -  To compare cladribine plus rituximab vs cladribine alone in terms of 1) initial MRD-free~          survival and disease-free survival, and 2) response to delayed rituximab for relapse, to~          determine if early rituximab compromises later response.~        -  To determine if MRD levels and tumor markers (soluble CD25 and CD22) after cladribine~          and/or rituximab correlate with response and clinical endpoints.~        -  To determine, using MRD and tumor marker data, when BMBx can be avoided.~        -  To compare response and MRD after the 1st and 2nd courses of cladribine.~        -  To evaluate the effects of cladribine and rituximab on normal T- and B-cells.~        -  To enhance the study of HCL biology by cloning, sequencing and characterizing monoclonal~          immunoglobulin rearrangements.~      Eligibility:~      HCL with 0-1 prior courses of cladribine and treatment indicated.~      Design:~      Cladribine 0.15 mg/Kg/day times 5 doses each by 2hr i.v. infusion (days 1-5)~      Rituximab 375 mg/m2/week times 8 weeks, randomized half to begin day 1, then repeat for all~     patients with blood-MRD relapse at least 6 months after cladribine. Also may repeat for those~     with blood-MRD relapse at least 6 months after delayed rituximab.~      MRD tests used for the primary objective will be limited to BMBx IHC, blood FACS or blood~     consensus PCR, all CLIA certified. Blood MRD relapse is defined as FACS positivity or low~     blood counts (ANC less than 1500/microl, Plt less than 100,000/microl, or Hgb less than 11).~      Stratification: 68 patients with 0 and 62 with 1 prior course of cladribine.~      Statistics: 80% power to discriminate rates of MRD of 5 vs 25%, or 10 vs 35%~      Non-randomized arm: 20 with HCLv will begin rituximab with cladribine.~      Accrual Ceiling: 152 patients (130 HCL, 2 extra HCL if needed, and 20 HCLv.)~   "
201656|NCT00922909|"~     Different results have recently led to question the classical notion according to which the~     motor and cognitive deficits in Parkinson's disease are tied to a thalamo-cortical inhibition~     due to the degeneration of the dopaminergic nigro-striatal pathways. Instead, Parkinsons's~     disease seems accompanied by an increase in motor cortical activity.~      A reaction time task, known as the Simon task in the literature, allows one to study the~     influence of irrelevant visual information on decision making. In the most common version of~     this task (used in the prosed study), the subjects have to choose between a left- and a~     right-hand keypress according to the color of a visual signal presented either to the left or~     to the right of a fixation. The to be established association is said congruent when the~     response is ipsilateral to the stimulus and incongruent when the response is contralateral~     to the stimulus. In healthy volunteers, EMG investigations have revealed that in a~     significant numbers of trials, the contraction of the response agonist is preceded by a~     infra-liminal contraction of the agonist involved in the non-required response. Such partial~     errors demonstrate that the nervous system is able to detect, abort and correct a part of~     its errors, thereby revealing the existence of an on-line executive control in simple~     decision tasks. Behavioral studies performed in Parkinson disease patients, suggest that~     these patients may experience a deficit in such a control.~      The present study aims at testing this hypothesis by assessing the effect of subthalamic~     stimulation on the patients' performance in a Simon task.~   "
201657|NCT00922896|"~     The purpose of this study is to determine the response rate of gemcitabine, cisplatin and~     erlotinib in metastatic pancreatic cancer.~   "
201658|NCT00922883|"~     Severe aplastic anemia (SAA) is a life-threatening blood disease which can be effectively~     treated with immunosuppressive drug regimens or allogeneic stem cell transplantation.~     However, 20-40% of patients without transplant options do not respond to immunosuppressive~     therapies, and have persistent severe thrombocytopenia. Even patients that respond to~     immunosuppressive therapies with an improvement in their life-threatening neutropenia~     sometimes have persistent thrombocytopenia. Both groups of patients (i.e. nonresponders to~     immunosuppressive therapy and responders with persistent thrombocytopenia) require regular~     platelet transfusions, which are expensive and inconvenient, and are a risk for further~     serious bleeding complications.~      Thrombopoietin (TPO) is the principal endogenous regulator of platelet production. On binding~     to the megakaryocyte progenitor TPO receptor, TPO initiates a number of signal transduction~     events to increase the production of mature megakaryocytes and platelets. Thrombopoietin also~     has stimulatory effects on more primitive multilineage progenitors and stem cells in vitro~     and in animal models. A 2nd generation small molecule TPO-agonist, eltrombopag (Promacta )~     has been shown to increase platelets in healthy subjects and in thrombocytopenic patients~     with chronic immune thrombocytopenic purpura (ITP) and hepatitis C virus (HCV) infection.~     Eltrombopag is administered orally and has been well-tolerated in clinical trials. Unlike~     recombinant TPO, it has not been found to induce autoantibodies. Eltrombopag received FDA~     accelerated approval on Nov 20, 2008 for the treatment of thrombocytopenia in patients with~     chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to~     corticosteroids, immunoglobulins, or splenectomy. Because a paucity of megakaryocytes and~     decreased platelet production is responsible for thrombocytopenia in aplastic anemia~     patients, we now propose this Phase 2, non-randomized pilot study of eltrombopag in aplastic~     anemia patients with immunosuppressive therapy refractory thrombocytopenia.~      Subjects will initiate study medication at an oral dose of 50 mg/day (25 mg/day for East~     Asians), which will be increased or decreased as clinically indicated to the lowest dose that~     maintains a stable platelet count 20,000/(micro)L above baseline while maximizing~     tolerability. Treatment response is defined as platelet count increases to 20,000/(micro)L~     above baseline at three months. Subjects with response at 3 months may continue study~     medication (extended access) until they meet an off study criteria.~   "
201659|NCT00922870|"~     Septic shock is a major cause of mortality and morbidity in critically ill patients. Septic~     Shock is associated with an overwhelming, systemic overflow of pro inflammatory and~     anti-inflammatory mediators, which leads to generalized endothelial damage, multiple organ~     failure, and altered cellular immunological responsiveness. Although our understanding of the~     complex pathophysiological alterations that occur in septic shock has increased greatly as a~     result of recent clinical and preclinical studies, mortality associated with the disorder~     remains unacceptably high, ranging from 30% to 50%. To date, attempts to improve survival~     with innovative, predominantly anti-inflammatory therapeutic strategies have been~     disappointing. A standard hemofiltration rate of 35 ml/kg/hour has been successfully used to~     treat acute renal failure. However, this dose does not alter plasma levels of inflammatory~     mediators, suggesting that its ability to clear these mediators is suboptimal. Higher doses~     of hemofiltration (up to 120 ml/kg per hour) have been demonstrated to improve cardiac~     function and hemodynamics in several animal models of sepsis. High-volume hemofiltration~     (HVHF) was thus conceived and applied in patients with septic shock, showing an improvements~     in hemodynamics with decreased vasopressor requirements and improved survival in patients~     admitted after a cardiac arrest.~      The main benefit described with high volume hemofiltration is a hemodynamic improvement (e.g~     reduction in catecholamines' requirement). This improvement seems to be due to the removal of~     a badly defined network of middle molecular weight peptides. To remove efficiently these~     middle molecular peptides, a high filtration rate is needed. However, with high filtration~     rates, there is also a high clearance for smaller molecules, including antibiotics,~     electrolytes, vitamins, trace elements and amino acids.~      The cascade hemofiltration system has been designed for a more efficient removal of middle~     molecular weight peptides with a limited solute consumption.~      The goal of this study is the evaluation of the hemodynamic improvement using cascade~     hemofiltration in patients treated for septic shock.~   "
201660|NCT00922857|"~     The prevalence of chronic respiratory failure (CRF) is increasing worldwide and will become~     the 3rd cause of death by 2020. At the stage of the disease requiring ventilatory assistance,~     this relates to 50,000 patients in France, life expectancy is very limited, and quality of~     life is poor.~      CRF led to a reduction in muscle mass, which is found in 35 and 55% of patients, in some to a~     profound cachexia. A reduced fat free mass (FFM) is a factor associated with a poor tolerance~     to exercise and an halved survival. The exact causes and mechanisms leading to cachexia are~     not yet established. Recently, a chronic inflammatory condition has been quoted as a putative~     cause. This chronic inflammation would involve the molecular mechanisms leading to poor~     regulation of the balance of synthesis / protein degradation in muscle. A decrease in plasma~     and muscle amino acids was found among patients with a low FFM.. In addition, a decrease of~     plasma levels of some anabolic hormones, GH and androgens or IGF-1 has been found that could~     explain a lack of protein synthesis.~      It is now well established that respiratory rehabilitation, including a program of exercise~     reconditioning, increases tolerance to exercise and improve the quality of life. Besides the~     classical type of endurance exercises stimulating the cardio-respiratory system, it is~     suggested to add resistance exercises. Several studies have reported the benefit of this~     strategy but the link with intracellular molecular pathways has not been described; moreover,~     it is unknown whether the existence of an initial muscular atrophy influences the gain in~     muscle strength/mass.~   "
201661|NCT00922844|"~     Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood~     pressure and systemic vascular resistance.~   "
201662|NCT00922831|"~     The purpose of this study is to look at multiple sclerosis patients process of awareness,~     learning, and judging status over a 3 year time period.~   "
201663|NCT00922818|"~     Our objective is to evaluate the clinical outcomes for the anatomic radical perineal~     prostatectomy (RPP) for the surgical management of prostate cancer. We will report the~     perioperative, oncologic, and functional outcomes in patients undergoing the radical perineal~     prostatectomy at our institution.~   "
201664|NCT00922805|"~     Short bowel syndrome (SBS) is a form of disease that results from removal of a significant~     portion of the intestine leading to poor nutrient absorption. Infants with short bowel~     syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the~     lack of effective therapies.~      Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits~     and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant)~     diarrhea in children.~      The purpose of this research study is to evaluate the many effects of fiber added in the diet~     of infants with SBS~   "
201665|NCT00922792|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting~     activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.~   "
201666|NCT00922779|"~     This single arm study will evaluate the safety and tolerability of ribavirin in combination~     with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or~     1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination~     with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months,~     and the target sample size is >500 individuals.~   "
201667|NCT00922766|"~     To collect data on safety and effectiveness of dalteparin in the management of non-ST segment~     elevated acute coronary syndromes in nursing home patients who will be treated conservatively~     (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG]~     within 48 hours).~   "
201668|NCT00922753|"~     Preoxygenation optimizes oxygen content in the functional residual capacity (FRC). Adequate~     preoxygenation is defined by an expiratory oxygen fraction (FEO2) > 90%. Inspiratory support~     and positive end expiratory pressure (PEEP) can create a better reservoir, improve gas~     exchange and shorten the time needed for adequate preoxygenation. The goal of the study is to~     evaluate the efficacy and tolerability of different levels of inspiratory support and~     positive end expiratory pressure during preoxygenation in healthy subjects.~   "
201669|NCT00922740|"~     The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and~     tissues over time and how the drug acts on and in the body at various dose levels compared to~     placebo in the same volunteer.~   "
201670|NCT00922727|"~     This study will evaluate the safety and tolerability of the probiotic Lactobacillus reuteri~     (LR) in healthy adult patients. Patients will be randomized to receive either LR or placebo~     orally each day for a total of 60 doses. The effects on fecal bacteria, circulating white~     blood cell receptors and inflammatory cytokine profiles will be measured.~   "
201671|NCT00922714|"~     This is a prospective double-blinded placebo-controlled block randomized study in intensive~     care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is~     an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential~     Organ Failure Assessment (SOFA) score on day 7 of treatment.~   "
201672|NCT00922701|"~     The development of glucose-sparing strategies able to provide an efficacious ultrafiltration~     profile represents one of the modern goals of peritoneal dialysis therapy. The study~     hypothesis is to evaluate the possibility to formulate peritoneal dialysis solutions~     containing L-carnitine as an osmotic agent to partially replace glucose.~   "
201673|NCT00922688|"~     Rationale: It is well known that insulin resistance occurs after mediocre and intensive~     surgery, such as colon cancer surgery. Disturbances in insulin action negatively affect the~     postoperative recovery, either by prolonging the capacity of the body to regain normal~     function, or by increasing the metabolic stress and the risk for complications. Several~     studies have shown that focusing therapies on improving insulin resistance is successful.~     Experimental studies have shown that antioxidant agents, like glutamine (a precursor of~     glutathione), improve insulin sensitivity. The hypothesis of this study is that perioperative~     parenteral or enteral administration of glutamine, given as the dipeptide alanyl-glutamine,~     will reduce or prevent postoperative insulin resistance in colon cancer patients. The study~     will also be focused on the different routes of administration, because of the expected~     differential metabolic effects.~      Objective: The investigators' primary objective is to study whether intravenous or enteral~     administration of the dipeptide alanyl-glutamine will reduce or prevent postoperative insulin~     resistance in colon cancer patients.~      Study design: A double-blinded, placebo controlled randomised, pilot study at the Surgery~     Department of the Medical Center Alkmaar.~      Study population: Thirty patients of male gender and any ethnicity, who will undergo elective~     open abdominal colon surgery for colon cancer, aged 18-75 years.~      Intervention: Patients will receive dipeptide alanyl-glutamine intravenously or enterally,~     starting 24 hours prior to surgery, until 24 hours after surgery in the dosage of 0.5~     g/kg/day, or saline (control group), for the same period of time.~      Main study parameters/endpoints: The main study parameter is postoperative insulin~     resistance. Secondary study parameters are lipolysis, oxidative stress and glucoregulatory~     hormones. Muscle, liver and fat biopsies will be taken to study insulin sensitive as well as~     inflammatory pathways.~   "
201674|NCT00922675|"~     Study objectives: To assess the effects of postconditioning on infarct size in patients with~     ST-elevation infarction referred to PCI.~      Study design: Prospective, randomized, open-label study with blinded endpoint evaluation.~     Included patients will be randomly allocated to postconditioning or control. Patients with~     symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria~     for primary PCI are eligible. PCI follow established routines. In postconditioning patients,~     additional, short (1 min), intermittent balloon occlusions will be applied after initial~     opening of infarct related artery. After this intervention, PCI proceeds routinely with stent~     implantation. In the control group, stent implantation after initial opening proceeds as~     usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients~     will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.~      Clinical implications: Reperfusion therapy, administered as early as possible after start of~     symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still,~     however, many patients suffer large infarctions, subsequently with an increased risk of heart~     failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown~     to reduce infarct size and thus potentially improve prognosis. However, the effect of~     postconditioning must be confirmed in larger clinical trials before implemented in routine~     treatment.~   "
201675|NCT00922662|"~     The purpose of the study is to establish an overarching database of information containing~     historical, demographical, clinical, and intermediate and long-term outcome data from all~     William Beaumont Hospital (WBH) patients undergoing Cardiac Computed Tomographic Angiography~     (CCTA) testing for clinical or scientific reasons.~   "
201676|NCT00922649|"~     16-week, open-label, multi-center pilot study. Insulin pump naïve subjects with type 2~     diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established~     regimen of either: 1) ≥ 2 OAs (Cohort A), 2) basal insulin ± OAs (Cohort B), or 3)~     basal-bolus insulin ± OAs (Cohort C) will initiate basal-bolus therapy with an insulin pump~     using a rapid-acting insulin analog.~   "
201679|NCT00922610|"~     This study will assess the efficacy and safety of once monthly administration of Mircera in~     Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and~     not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting~     dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin~     level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study~     treatment is 3-12 months, and the target sample is <100 individuals.~   "
201680|NCT00922597|"~     The objective of this international post-marketing surveillance study is to collect data on~     the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.~   "
201681|NCT00922584|"~     This trial's aim is to evaluate the efficacy and toxicity of sorafenib in relapsed advanced~     Non-Small Cell Lung Cancer (NSCLC) after failure of epidermal growth factor~     receptors-tyrosine kinase inhibitor (EGFR-TKI) treatment and to explore the correlation~     between clinical outcomes and biochemical modulation of signal transduction pathways.~   "
201682|NCT00922571|"~     The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser~     System to perform surgical maneuvers during cataract extraction surgery.~   "
201683|NCT00922558|"~     Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of~     electronic signals emitted by four footplates, one for each heel and toe, respectively. These~     are sensitive to vertical pressure produced by a subject standing straight but in various~     positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields~     additional parameters not obtained by the traditional monoplate stabilometers, namely,~     weight-distribution patterns and correlation among six combinations of paired outputs from~     the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric~     synchronizations). Comparing age-matched learning disabled, mentally retarded, autistic, and~     hearing impaired (with and without labyrinthine hypofunction) with normal children,~     significant and clinically meaningful differences were detected between the~     Tetra-ataxiametric measures of stability, interaction between Fourier Spectral Power Ranges~     of body sway, weight distributions, and synchronizations of toe parts. The same parameters~     correlated significantly with cognitive school readiness in normal populations. While the~     stability and spectral quotients show significant developmental changes, weight distribution~     and toe synchronisations are stable from 5 years onwards. The method is suitable for young~     subjects and attractive to children who may ordinarily be reluctant to cooperate, such as the~     autistic ones. The equipment is portable and tests can be conveniently carried out in a~     child's familiar educational setting.~   "
201684|NCT00922545|"~     Main objective:~      Evaluate the effectiveness of a combined strategy addressed to health care workers and~     patients, in relation to improving clinical control and patient's quality of life.It includes~     a feed-back about the health status of the patients, an education plan addressed to~     practitioners based in a CPG and in health education~   "
201685|NCT00922532|"~     This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm~     the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure~     associated with pulmonary hypertension in preterm infants.~      Study subjects will be administered either inhaled nitric oxide or placebo to determine if~     there is a change in oxygenation.~   "
201686|NCT00922519|"~     This study is being done to provide an alternative to bone scanning with technetium-99m~     (99mTc) labelled diphosphonates, and to document the safety of {18F}-Sodium Fluoride (Na18F)~     as a Positron Emission Tomography (PET) imaging radiopharmaceutical. Since the current~     availability of 99mTc was severely reduced because of the Chalk River shut down, alternative~     approaches to done scanning are needed. PET imaging with Na18F is one alternative approach to~     providing this critical clinical service.~   "
201687|NCT00922506|"~     OAB occurs in approximately 50% to 75% of men with BPO and up to 38% of men with BPO continue~     to suffer from OAB after relief the obstruction.Symptoms of OAB are more bothersome than the~     voiding complaints of slow stream and hesitancy. However, the patients with both BPO and OAB~     are often not treated with muscarinic receptor antagonists due to concern that they will~     experience acute urinary retention.~      Tolterodine is a potent and pure muscarinic receptor antagonist that was developed~     specifically for the treatment of overactive bladder. Recently, studies revealed that~     tolterodine was effective, safe and well tolerated in adults with OAB and urodynamically~     confirmed BPO.However, the optimal dosage of antimuscarinic for the treatment of OAB~     coexisting BPO was not yet fully assessed. In real clinical situation, some patients complain~     voiding difficulty after addition of antimuscarinics and want to stop antimuscarinics.It is~     probable that a lower dosage of antimuscarinics combined with alpha-adrenergic antagonists~     can be used safely in OAB patients with BOO, with the same efficacy.~      This study is designed to investigate the optimal doses of tolterodine SR in combination with~     doxazosin in men with both BOO and OAB based on efficacy, safety, and tolerability.~   "
201688|NCT00922493|"~     Background: the objective of the present inquiry was to evaluate the weaning process in~     intubated older people subjected to inspiratory muscle training and to correlate the~     predictors of ventilatory interruption with its success.~      Methods: the patients were divided randomly into an experimental group (EG, n=14; age=82±4~     years) that received conventional physiotherapy plus inspiratory muscle training (IMT) with~     threshold IMT® and a control group (CG, n=14; age=81±6 years) that received only conventional~     physiotherapy. The predictors evaluates were the maximum inspiratory pressure (MIP) and the~     index of Tobin (IT). The protocol for muscle training consisted of an initial load of 30%~     MIP, which was increased by 10% daily; training was administered for five minutes, twice a~     day, seven times a week with supplemental oxygen for the entire period from the decision to~     wean up to extubation.~   "
201689|NCT00922480|"~     The purpose of this study is to evaluate the antihypertensive efficacy and safety of~     Fimasartan (BR-A-657•K) 60 mg~120 mg in patients with mild to moderate essential~     hypertension.~   "
201690|NCT00922467|"~     Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol~     and remifentanil~   "
201691|NCT00922454|"~     The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent~     Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical~     Center and St. Peter's Hospital in Albany, NY.~      The investigators are comparing the two devices as part of the evolution of endovascular~     repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23,~     2003, the Talent Abdominal Stent Graft System on April 15, 2008.~   "
201696|NCT00922389|"~     The purpose of this study is to determine whether the method (implanting stem cells derived~     from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the~     management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by~     improving blood circulation in ischemic limb which would in turn promote ulcer healing,~     prevent amputation of limb and relieve the Sevier pain of ischemia.~   "
201697|NCT00922376|"~     New telemedicine systems have been designed to assist people suffering from diabetes in the~     management of their chronic disease. More recently the focus has been moving to portable~     systems equipped with Bluetooth. This study consists of evaluating an application called the~     Think Positive (T+) diabetes management software. It is a randomized controlled trial~     designed to compare, over a nine month period, a group of patients receiving usual care with~     a group of patients using the T+ system. The objectives of the study are to investigate the~     extent to which this telemedicine application helps patients control their blood sugar levels~     (HbA1c), as well as the extent to which its users consider it to be acceptable. The impact of~     its use on factors such as diabetes self-care, health status, quality of life,~     self-confidence in diabetes management, fear of hypoglycemia and illness representations will~     also be examined. Because of the supplementary real-time support and feedback that T+ offers,~     its use should lead to better outcomes in diabetes management than usual care does.~   "
201698|NCT00922363|"~     The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg~     Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four~     groups of healthy volunteers, injecting two doses with two months interval.~   "
201699|NCT00922350|"~     The purpose of this study is to verify that nebulization with bronchodilators associated with~     heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in~     patients with an asthma attack.~   "
201700|NCT00922337|"~     the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical~     Performance of the InspireMD MGuard Coronary Stent System~   "
201701|NCT00922324|"~     The study will assess the safety, tolerability and fecal shedding of STP206 when given as a~     single dose and when given as daily doses for one week.~   "
201702|NCT00922311|"~     Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel~     direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in~     immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.~   "
201703|NCT00922285|"~     RATIONALE: Art therapy may help relieve emotional distress in caregivers of young patients~     undergoing bone marrow transplant for cancer.~      PURPOSE: This clinical trial is studying art therapy for caregivers of young patients~     undergoing bone marrow transplant for cancer.~   "
201704|NCT00922272|"~     To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical~     antipsychotic medication, on negative symptoms in adult subjects with clinically stable~     schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment~     of Negative Symptoms (SANS).~   "
201705|NCT00922259|"~     Every year the human population suffers from seasonal outbreaks of influenza resulting in~     both illness and death. However, the rates of illness and death from seasonal outbreaks are~     significantly lower than those suffered during times of influenza pandemic, such as those~     experienced in 1918, 1957, and 1968. The reason for this difference lies in presence of~     immunity within a population. With seasonal outbreaks of influenza most people have some~     immunity to the circulating strain and usually only those with weakened immune systems~     experience serious complications. Influenza pandemics, in contrast, are the result of a~     completely new viral subtype to which nobody possesses an immunity, leaving everyone~     vulnerable to the most serious of complications.~      It has been estimated that the next flu pandemic could cause over 200,000 deaths and over~     700,000 hospitalizations in the US alone. The need for an effective viral vaccine is high.~     The purpose of this study is to test the safety and immunogenicity of a live influenza A~     strain vaccine, which would be able to combat an influenza pandemic.~   "
201706|NCT00922246|"~     To address whether custom made foot insoles could be used for primary prevention of lower~     limb overuse injuries, the investigators conducted a prospective, randomized controlled study~     comparing the use of insoles and standard shoes in healthy young adults exposed to increased~     physical activity.~   "
201707|NCT00922233|"~     A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and~     acceptability of pericoital oral contraception with levonorgestrel~   "
201708|NCT00922220|"~     The purpose of this study was to determine the immediate effect of 3 common physical therapy~     interventions for people experiencing low back pain on the perception of thermal pain.~     Additionally, the investigators wished to determine the influence of psychological factors~     related to fear and anxiety on their findings and to determine whether the effects of the~     individual interventions were local (specific to the area of application) or global~     (influenced regions away from the area of application).~   "
201709|NCT00922207|"~     This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with~     Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be~     randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4~     to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or~     3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment~     will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study~     treatment is 1 year, and the target sample size is 100-500 individuals.~   "
201710|NCT00922194|"~     The study included 102 overweight type 2 diabetes mellitus patients with a body mass index~     (BMI) of more than 25 in an open label study. They were advised intensive life style~     modification which was reinforced at each follow-up visit. In addition they were prescribed~     extended release metformin (XR) in a gradually increasing tolerable dose, starting with 0.5g~     twice a day after meals. In addition, hypertension and dyslipidemia, when present, were~     treated with appropriate recommended drugs. Those who completed a satisfactory regular~     follow-up for at least 12 months or more were then analyzed for changes in their~     anthropometric measurements and glycemic control.~   "
201715|NCT00922129|"~     The purpose of this study is to evaluate the role and effectiveness of conversion to~     sirolimus versus CNI reduction in renal transplant patients with prostate cancer.~   "
201716|NCT00922116|"~     This single arm study will assess the efficacy, safety and tolerability of once monthly~     administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients~     with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose~     of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA~     previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels~     within the target range. The anticipated time on study treatment is 3-12 months, and the~     target sample size is 100-500 individuals.~   "
201717|NCT00922103|"~     For patients with ulcerative colitis, eligible for surgical treatment, which restorative~     surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo~     rectal anastomosis is the best in terms of complications, functional outcome and health~     status and quality of life.~   "
201718|NCT00922090|"~     The primary objective of this NIS is to assess the clinical benefit subjects derive from~     taking seroquel XR, using the CGI-CB. The secondary objective is to assess the~     effectiveness,safety and tolerability of seroquel XR tablets.~   "
201719|NCT00922077|"~     The purpose of the study was to evaluate this therapeutic intervention by expressing~     functional level with valid quantitative data.~   "
201720|NCT00922064|"~     In treatment-resistant depression, electroconvulsive therapy (ECT) has been shown to~     effectively reduce depressive symptoms, though the underlying neurobiological mechanism is~     still unclear. The serotonergic system, and in particular the inhibitory serotonin-1A~     (5-HT1A) receptor, appears to be significantly involved in the effectiveness of ECT. The aim~     of the study is to assess the effects of ECT on the 5-HT1A receptor binding potential (BPND)~     and distribution in humans in vivo using positron emission tomography (PET) and the~     radioligand [carbonyl-11C]WAY-100635.~      12 patients suffering from severe, therapy-resistant unipolar depression will undergo 3 PET~     scans, two of these scans taking place before the ECT treatment, consisting of 6-14 ECTs, the~     third scan taking place after the ECT treatment.~      This imaging study hypothesizes that upon completion of the ECT, the overall 5-HT1A receptor~     BPND in the brain of depressed patients will significantly change.~      This study would be the first to demonstrate an effect of electroconvulsive therapy on the~     5-HT1A receptor binding in humans in vivo. Given the involvement of the 5-HT1A receptor in~     the pathophysiology of mood disorders, the present study would be an important step towards a~     better understanding of antidepressant treatment and treatment response. By comparing~     treatment effect and the underlying biological mechanism, the study might help to identify~     biomarkers that distinguish patients who are likely to benefit from ECT from patients who~     will rather be non-responders. Finally, by investigating the role of the 5-HT1A receptor in~     ECT, is highly discussed relevance for antidepressant action will be further elucidated and~     might prepare the ground for new therapeutic strategies.~   "
201721|NCT00922051|"~     The objective of this study is to investigate the effectiveness of Acu-TENS (transcutaneous~     electrical nerve stimulation applied on acupoints) on lung functions, dyspnoeic symptoms and~     its association with beta endorphin level in subjects with COPD.~   "
201722|NCT00922038|"~     This project evaluates the effect of a combined economic and psycho-social intervention to~     reduce risky sexual activity and its consequences. The main hypothesis to be tested is that~     risky sexual activity and resulting sexually transmitted infections (STIs) can be reduced~     through an intervention of counseling, regular STI testing, and positive reinforcement using~     cash rewards. The intervention is being implemented in a population of young people in rural~     Tanzania where more conventional behavioral change interventions have had limited effect in~     battling a generalized HIV epidemic.~   "
201723|NCT00922025|"~     The objective is to investigate the correlation between smoking pattern and clinical efficacy~     of EGFR TKIs in male patients with locally advanced or metastasized non-small cell lung~     cancer of adeno histology who have failed 1st line chemotherapy. Health care resource usage,~     quality of life (EQ-5D) and practice of EGFR mutation test will also be evaluated. Current~     practice of EGFR mutation testing in Taiwan will be surveyed.~   "
201724|NCT00922012|"~     In 1995 the National Institutes of Health-National Institute of Diabetes and Digestive and~     Kidney Diseases (NIDDK) workshop reached a consensus on the definition and classification of~     prostatitis syndromes.The commonest and yet most poorly understood of these prostatitis~     syndromes is category III or chronic pelvic pain syndrome (CPPS). It has been shown that,~     while men with CPPS have significantly higher leukocyte counts in urine and expressed~     prostatic secretions compared with age matched controls, inflammation and infection do not~     necessarily correlate with symptom severity.~      The lack of a direct relationship between inflammation and symptoms is supported through~     studies of prostate histopathology, in which moderate or severe inflammation was identified~     in only 5% of men with CPPS.Conventional treatment has focused on long, empirical courses of~     expensive broad-spectrum antibiotics, mostly of the quinolone class, with or without the~     concomitant use of an α-blocker and anti-inflammatory agents. At the turn of the 19th century~     stimulation with electrical current and changing magnetic fields was used to treat surface~     conditions associated with intractable pain, such as painful malignant ulcers. The analgesic~     benefits of pulsed electromagnetic fields for relieving pelvic pain has been investigated in~     women with tissue trauma and chronic refractory pelvic pain.Despite its uncertain etiology~     there is some evidence that the symptom complex found in CPPS may be founded at least in part~     in pelvic floor muscular dysfunction and/or neurogenic hypersensitivity/inflammation.~      We hypothesized that the application of a electromagnetic stimulation to the perineum of the~     subject may result in neural excitation and pelvic floor muscle stimulation to a degree that~     breaks the cycle of tonic muscular spasm and neural hypersensitivity/inflammation, thereby,~     restoring more normal pelvic floor muscular activity.~   "
201725|NCT00921999|"~     Background:~        -  The common varicella-zoster virus causes both chickenpox and shingles. Both diseases~          cause rashes, but they can also have complications such as bacterial infections of the~          skin, pneumonia, or eye disease.~        -  By drawing and studying blood samples from people who have been infected with the~          varicella-zoster virus or who are receiving or have received the varicella vaccine,~          researchers hope to learn more about the immune system s response to the virus.~      Objectives:~      - To determine the immune system s response to the varicella virus, either in its existing~     form or given as part of a vaccine.~      Eligibility:~        -  Individuals 18 years of age and older who have had or are receiving the varicella~          vaccine.~        -  Individuals 5 years of age and older who currently have chickenpox or shingles.~      Design:~        -  Participants will visit the NIH Clinical Center for an initial physical examination, and~          will provide blood samples for evaluation.~        -  Researchers will determine the number of samples to be taken and the amount of blood to~          be drawn as needed based on the participants medical history and exposure to the~          varicella-zoster virus.~      Investigators in this study will not be giving subjects either the chickenpox or shingles~     vaccine. They will only be looking at the response to the vaccine in persons who are~     receiving or have received the vaccine from their health care provider.~   "
201727|NCT00921973|"~     The study will assess the safety, reactogenicity, and tolerability of VAX102 when given with~     Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM~     injections in healthy adults 18 to 49 years. The investigators will measure the~     immunogenicity of the VAX102 when given with TIV and the antibody response to TIV when given~     with VAX102 compared to TIV alone.~   "
201728|NCT00921960|"~     The STOP-HF study is a prospective, randomized, controlled trial recruiting asymptomatic~     individuals with risk factors for left ventricular dysfunction from 50 primary care clinics~     in Dublin and south east Ireland. It is designed to determine whether using natriuretic~     peptide measurement as a screening tool following a general cardiovascular risk factor screen~     will reduce the prevalence and severity of ventricular dysfunction in conjunction with~     specialist follow-up at St. Vincent's University Hospital.~   "
201729|NCT00921947|"~     1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the~          VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level~          delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.~        2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102~          vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered~          i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked~          immunosorbent assay (ELISA) in a healthy adult population.~   "
201730|NCT00921934|"~     Chronic viral infections induce oxidative stress that can cause a number of concomitant~     diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient~     treatment of oxidative stress may be of benefit for the patient to prevent further diseases.~      Shingles (herpes zoster infection) have been successfully treated with antioxidative~     substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished~     by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may~     be mitigated or even fully avoided.~   "
201731|NCT00921921|"~     Chronic obstructive pulmonary disease or 'COPD' is a chronic disease, which means that it~     cannot be cured, but that inhalers and tablets can be used to control the symptoms. In COPD,~     the airways become inflamed which can cause coughing and make the airways tighten. This~     'inflammation' is the root of the problem in COPD.~      The airways of the lung start in the windpipe and branch like the branches of a tree, getting~     smaller and smaller. In COPD the inflammation is deep in the lungs, out to the very small~     airways.~      Different inhalers make the medicines into different sized particles. Most steroid inhalers~     used for COPD make the medicine into particles which are too big to get into the very small~     airways ('coarse particles'). Other inhalers make a mist, with much smaller particles ('fine~     particles'). These are as small as the smallest airways in the lungs.~      Doctors have recently found a way to measure the inflammation in the small airways that are~     affected in COPD. The investigators want to find out if taking one of these 'fine-particle'~     steroid inhalers can treat that inflammation.~   "
201732|NCT00921908|"~     Postoperative administration of local anesthetics is effective for postoperative pain~     management across surgical specialties but the optimal type of catheter (single, few or~     multiholed catheters) has not been determined.~      This study investigates wound spread of a radioactive isotope (technetium) administered in~     different types of catheters after total hip arthroplasty.~   "
201733|NCT00921895|"~     To engage in a multi-center, prospective, masked clinical trial to investigate a~     non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the~     presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to~     cell culture with confirmatory immunofluorescence (CC-IFA). The polymerase chain reaction~     (PCR) will be used as a referee for discrepant cases.~   "
201734|NCT00921882|"~     Within 6 months of delivery, women who had gestational diabetes mellitus should be screened~     for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in~     a 75-g oral glucose tolerance test. However, not all women are screened. The objective of~     this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum~     versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity,~     false and true predictive values of the screening test at 48 hours post-partum compared to~     the gold-standard.~   "
201735|NCT00921869|"~     The purpose of this study is to determine the maximum tolerated dose (MTD), safety,~     pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when~     administered orally twice daily to patients with advanced solid tumors.~   "
201736|NCT00921856|"~     In patients with chest pain and/or shortness of breath coronary artery disease (CAD) is~     suspected depending on the pattern of symptoms and the electrocardiogram (ECG). Coronary~     angiography is the method of choice to verify this suspicion. If the patient coronary~     arteries on coronary angiography are totally normal, one can only speculate if the patients'~     discomfort is from the heart or not. A possibility to get further information about the~     healthiness of the coronary arteries is the acetylcholine test (ACH-test). When injecting~     this natural, body produced-substance into the coronary arteries one can test if the vessels~     coronary spasm which can be the reason for the patient's symptoms. The investigators~     therefore use this test in this study to look for coronary spasm in patients with suspected~     CAD but normal coronary arteries. In case of a positive test, the patient profits from having~     found a cause for his/her symptoms making treatment with special tablets possible.~     Furthermore, the investigators want to analyze blood samples of every patient to look for~     signs of inflammation that seem to be linked with coronary spasms. On the basis of these~     results the ACH-test could probably be avoided in the future.~   "
201737|NCT00921843|"~     This study will determine the pharmacokinetics of intravenous (IV) methadone in children~     undergoing surgery.~   "
201738|NCT00921830|"~     The purpose of this study is to compare the pharmacokinetic and bioavailability~     characteristics of two test formulations of ibuprofen for rectal administration with the~     profile of a marketed reference formulation of ibuprofen 200 mg (for oral administration).~   "
201739|NCT00921817|"~     This study will test a new method for measuring body fat and muscle in infants and children:~     QMR.~   "
201740|NCT00921804|"~     The purpose of this study is to determine whether treatment with daily oral dose of AZD8529~     40 mg administered over 28 days is safe, well tolerated and improves main symptoms of~     schizophrenia in adult schizophrenia patients.~   "
201741|NCT00921791|"~     High blood pressure is the main risk factor for cardiovascular disease worldwide,but its~     control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic~     oscillometric devices and pharmaceutical care have been proposed as interventions to increase~     therapeutic compliance and to guide treatment decisions.~      The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in~     blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).~   "
201742|NCT00921778|"~     The occurrence of persistent vaginal bleeding following laparoscopic supracervical~     hysterectomy (LSH) is reported in the wide range of 0 % - 25 %. Experienced gynaecologists~     have claimed that removal of any remaining endometrium in a reverse cone pattern at the time~     of the hysterectomy reduces the occurrence of persistent vaginal bleeding to a minimum. The~     effect of this particular technique has not been reported.~      Ullevaal University Hospital have developed an unipolar electrode for this study (Lapcone~     electrode, mod. UUS, L: 25cm, 6x10, Art. No. REM-270, Ross Electro Medical Ltd, Unit K1&K2,~     Quarry Fields Estate, Mere, Wiltshire BA12 6LA, London, UK). The electrode is CE approved.~      Outcome: 1.Occurrence of vaginal bleeding 12 months after the procedure. 2. Patient~     satisfaction 12 months after the procedure (10-point analogue scale).~      Design: Prospective randomised trial. Methods; The study participants are randomised to~     laparoscopic supracervical hysterectomy performed by perioperative electrocoagulation from~     the upper cervical canal (n=70) or performed by excision of the endocervix in a reverse cone~     pattern followed by electrocoagulation of the upper cervical canal (n =70).~   "
201743|NCT00921765|"~     The purpose of this study is to determine whether the analgetic and other effects effect of~     ketamine are partly mediated through opioid receptors~   "
201744|NCT00921752|"~     To demonstrate a higher percent rate of achieved target lipid goals among patients at high~     cardiovascular risk using more potent lipid-lowering treatment options including high-potency~     statins and combination therapies.~   "
201745|NCT00921739|"~     Hypothesis 1- Using IMRT, the radiation therapy (RT) dose can be safely escalated from 58 Gy~     to 74 Gy given as 6 fractions/week with concurrent chemotherapy.~      Hypothesis 2- Esophageal motion can be used to customize planning organ at risk volumes.~      Hypothesis 3- Biological predictors of acute esophagitis can be used to identify patients at~     high risk of developing esophageal toxicity from radiation therapy and chemotherapy.~   "
201746|NCT00921726|"~     Due in part to widespread availability of oseltamivir and clinical experience using~     oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become~     resistant to it. Other reliable methods of treating H5N1 must be identified in case of a~     pandemic. One such option is intravenous zanamivir used in combination with oseltamivir. The~     primary purpose of this study is to evaluate the interaction between oral oseltamivir and~     intravenous zanamivir administered as either a continuous or intermittent infusion in healthy~     adults.~   "
201747|NCT00921713|"~     The purpose of this proposal is to develop and test the efficacy in a randomized, controlled~     clinical trial of an Oncology Nurse Care Management (ONCM) program to support cancer patients~     early in their course. The ONCM program will be compared with an Enhanced Usual Care (EUC)~     program that will provide education materials and treatment resources for patients. Efficacy~     will be measured by differences over time in participant-reported Quality of Life, Symptoms~     and Emotional Distress, and Quality of Care between patients receiving ONCM versus EUC.~   "
201748|NCT00921700|"~     The purpose of this study is to determine whether the combination of paracetamol~     (acetaminophen) and other NSAIDs with or without weak opioids can give synergistic analgesic~     effect.~   "
201749|NCT00921687|"~     Chronic kidney disease (CKD) is defined as kidney damage for greater than 3 months or a~     glomerular filtration rate less than 60 mL/min per 1.73m2 for greater than 3 months. Patients~     with CKD are at high risk for development of cardiovascular disease and metabolic~     complications. Guidelines for the care of patients with CKD have been developed by the~     National Kidney Foundation. Despite the wide availability of these guidelines, adherence is~     low. The goal of the current study is to evaluate whether a multifactorial intervention,~     including a CKD registry, will improve CKD guideline adherence. The hypothesis is that~     providers exposed to a multifactorial clinical intervention including education, academic~     detailing, and a CKD registry will be more likely to adhere to CKD guidelines than those only~     exposed to education.~   "
201750|NCT00921674|"~     The purpose of this study was to compare the pharmacokinetic and bioavailability profile~     (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin~     solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken~     after a standard meal. The study is designed in accordance with the EU Note for Guidance on~     the Investigation of Bioavailability and Bioequivalence 2001.~   "
201751|NCT00921661|"~     The primary objective is to determine the dose of aflibercept to be further studied in~     combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with~     metastatic colorectal cancer.~      Secondary objectives of this study are to assess the safety profile of aflibercept, to~     determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor~     effects.~   "
201752|NCT00921648|"~     This is a study of the clinical and neuroimaging of general paresis. The investigators~     studied six patients with general paresis.~   "
201753|NCT00921635|"~     The purpose of this study is to assess the feasibility, safety and short term effects on~     health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100~     to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for~     cancer of the cervix.~   "
201773|NCT00921375|"~     This study is a prospective, open-label, multicentre study. Hundred eligible patients with~     stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a~     peripheral white blood cell (WBC) count of > 25,000/µL or any leukemia or lymphoma with~     plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body~     weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in~     plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and~     incidence of adverse events will be assessed during 11 days study period.~   "
201777|NCT00921323|"~     The purpose of this study is:~        -  To validate the use of pedometers in assessing the level of physical activity in middle~          school children.~        -  To evaluate whether setting a step goal through the use of pedometers could increase~          physical activity and prevent weight gain in middle school children.~   "
201754|NCT00921622|"~     There is suggestive evidence that vitamin C and vitamin D deficiency may increase blood~     pressure across the range of blood pressures from normal to elevated. Information about this~     relationship is inadequate in part because of the rarity of individuals with subclinical~     vitamin C and D deficiency. The investigators have observed subnormal to deficient plasma~     vitamin C and 25-hydroxyvitamin D levels in a large proportion of patients under active~     treatment in the investigators' hospital. The clinical implications of widespread~     hypovitaminosis C and D are unknown. In this randomized prospective comparison trial the~     investigators will measure vitamin levels and blood pressure in clinically stable acutely~     hospitalized patients with a wide range of diagnoses, and expected to remain in the hospital~     for at least 7 more days. The investigators will examine for an inverse relationship between~     baseline vitamin level and blood pressure across the range of blood pressures. Consenting~     patients will be randomized to receive vitamin C (500 mg twice daily) or vitamin D (1000 IU~     twice daily) for as long as 10 days. Blood pressure will be re-measured every 2 days and~     vitamin levels re-measured on the last study day. Treatment courses of at least 5 days will~     be considered sufficient for analysis. The hypothesis is that either treatment will reduce~     blood pressure in patients whose baseline systolic blood pressure is 110 or more; the~     investigators will also examine whether the reduction in blood pressure with treatment is~     proportional to the increase in the circulating vitamin level with treatment.~   "
201755|NCT00921609|"~     Acromegaly is a rare disorder characterized by excessive production of growth hormone most~     often by a pituitary adenoma. A pituitary adenoma is a tumor, almost always benign or~     non-cancerous, that grows on the pituitary, a small gland located at the base of the brain.~     Treatment of acromegaly usually involves surgery, medication, or radiation, but can involve a~     combination of these three treatments.~      Subjects for this study will be recruited if they are:~        1. Adults, male or female, between the ages of 18-90.~        2. Have been diagnosed with acromegaly, based on elevated levels of growth hormone, IGF-I~          (a hormone made in response to growth hormone), and a pituitary adenoma visualized on an~          MRI.~        3. Patients would have already agreed to have their acromegaly treated with surgery prior~          to study entry.~      Subjects will have measurements of growth hormone using an oral glucose tolerance test~     (OGTT), IGF-I, free IGF-I and levels of IGF binding proteins at four time points after their~     pituitary surgery: Day 1, Day 42 (6 weeks), Day 84 (12 weeks), and day 365 (1 year). Subjects~     will also have an MRI of the pituitary done at 12 weeks and 1 year. OGTT and IGF-I are~     routinely measured to assess whether or not a person is cured of their acromegaly. An MRI of~     the pituitary is routinely done at 12 weeks and 1 year after surgery to assess the results of~     surgery. Free IGF-I and IGF binding proteins are not routinely measured after surgery, but~     are being done to see if they relate more strongly to disease activity than IGF-I and growth~     hormone.~      OGTT and the IGF-I binding proteins are not routinely measured on the day after surgery, but~     are being done to examine the predictive ability of these tests at a very early time after~     surgery. Data obtained from these tests will be compared to the data gathered at the 1 year~     time point.~      IGF-I and growth hormone will be measured by a commercial clinical lab, Quest Diagnostics,~     for clinical decision-making at the time of service. IGF-I and growth hormone will also be~     measured using other methods to attempt to investigate the variability of these hormones when~     different assays are used.~   "
201756|NCT00921596|"~     Conventional cardiac operations are performed with median sternotomy, which is related to~     great wound, morbidities, longer duration in hospital and most significantly, cosmetic~     problems. The investigators invested a new minimally invasive cardiac operation method~     totally under video-endoscope and peripheral cardiopulmonary bypass. The investigators'~     hypothesis is that this new minimally method could provide better cosmetic effects to the~     patients, and also relate to shorter postoperative hospital stay and better recovery.~   "
201757|NCT00921583|"~     Since 1986, newly developed titanium implants with a TPS surface have been utilized for the~     treatment of partially edentulous patients with implant supported fixed dental prostheses~     (FTP). In the beginning, these implant types have been sold by Straumann under the brand name~     Bonefit implants, later ITI Dental Implant System From the beginning, the first 75~     patients have been documented in a prospective case series study, and clinical and~     radiographic results have been reported at 1-year, 3-years, 5-years and 8-years.~      The aim of the present study is to examine the long-term outcomes of this original group of~     patients with at 20 years of clinical function, and to assess the frequency of biological and~     technical complications during this follow-up period.~   "
201758|NCT00921570|"~     Diabetic nephropathy (DN) is the most important complication of diabetes mellitus (DM) and~     the most common cause of end-stage renal disease (ESRD). Diabetic nephropathy is a clinical~     syndrome characterized by persistent albuminuria (> 300 mg/d or > 200 mcg/min) that is~     confirmed on at least 2 occasions 3 to 6 months apart, a relentless decline in the glomerular~     filtration rate (GFR), and elevated arterial blood pressure. In addition to the renal~     hemodynamic alterations, patients with overt diabetic nephropathy (dipstick-positive~     proteinuria and decreasing GFR) generally develop systemic hypertension. Hypertension is an~     adverse factor in all progressive renal diseases and seems especially so in diabetic~     nephropathy. The deleterious effects of hypertension are likely directed at the vasculature~     and microvasculature. Use of angiotensin converting enzyme (ACE) inhibitors and/or~     angiotensin receptor blockers (ARBs), strict glycemic control and use of antilipidemic drugs~     may improve progression of DN.~      TNF-like weak inducer of apoptosis (TWEAK, TNFSF12) is a member of the TNF superfamily of~     structurally related cytokines. The human TWEAK gene encodes a 249-amino acid type II~     transmembrane glycoprotein (30 kD). TWEAK may be expressed as a full-length, membrane-bound~     protein and as a 156-amino acid, 18-kD soluble protein, (sTWEAK) that results from~     proteolysis of TWEAK. TWEAK gene is expressed in many tissues, including brain, kidney,~     heart, arterial wall, monocytes and macrophages. Reduced soluble TNF-like weak inducer of~     apoptosis (sTWEAK) plasma levels have been reported both in patients with subclinical~     atherosclerosis and chronic kidney disease (CKD).~      Long pentraxin 3 (PTX3) is a multimeric inflammatory mediator. Increased serum PTX3 levels~     have been reported among end-stage renal disease patients. Moreover, PTX3 has been suggested~     to represent a novel mortality risk factor, and elevated PTX3 levels have been shown to~     accompany increased albuminuria among patients with chronic kidney disease (CKD).~      There is no data about the effects of Renin angiotensin system blockage (RAS), calcium~     channel blocker and combined drugs on TWEAK and PTX3 levels in diabetic proteinuric patients~     with hypertension. The aim of this study was to find out whether the beneficial effects of~     RAS blockage, calcium channel blocker and combined drugs in diabetic hypertensive proteinuric~     patients has any relation with the alteration of TWEAK and PTX3 levels. The investigators~     searched for the effects of angiotensin II (AII) receptor blocker (Valsartan 160 mg), calcium~     channel blocker (Amlodipine 10 mg) and AII receptor blocker plus calcium channel blocker~     (Valsartan 160 mg + Amlodipine 10 mg) on the clinical and laboratory parameters of diabetic~     hypertensive proteinuric patients.~   "
201759|NCT00921557|"~     HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be~     expected for HIV-uninfected people of similar age, weight and race. As the majority of~     perinatally HIV-infected U.S. children are entering or in adolescence, the potential for~     HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular~     concern. The primary purpose of this study was to compare changes from pre-treatment levels~     of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with placebo in~     HIV-infected children and adolescents.~   "
201774|NCT00921362|"~     Patients eligible for entry into the study have a diagnosis of schizophrenia defined by~     Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of~     a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms~     changes over 6 months in schizophrenia in patients treated with Seroquel; additionally~     disease severity and treatment compliance are followed~   "
201807|NCT00920933|"~     This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils~     that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo,~     or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.~   "
201760|NCT00921544|"~     Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and~     therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care~     Unit. Therefore strategies for stress reduction and pain management are essential to promote~     growth and development and minimize long-term sequelae. Procedural analgesia should include~     concepts of developmental care, non nutritive suck (NNS), pharmacological and~     non-pharmacological agents. Sucrose is thought to stimulate the body's activation of lingual~     sweet taste receptors and release of endogenous opioids, when combined with NNS, non-opioid~     mechanisms are also activated. The administration of sucrose or the combination of sucrose~     and non-nutritive sucking is one of the most frequently studied non-pharmacological~     interventions for relief of pain in neonates and oral sucrose has been shown to be an~     effective and safe therapy for common neonatal procedures such as heal lance, blood-letting~     and venepuncture. There is conflicting evidence on the benefit of sucrose in ROP screening.~     Therefore the purpose of this study is to determine the efficacy of sucrose combined with NNS~     as a potential regime for reduction of pain associated with retinopathy of prematurity~     screening.~   "
201761|NCT00921531|"~     Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas.~     Randomized clinical trials indicated that TACE improves overall survival in patients with~     good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia~     induced neoangiogenesis after blockage of blood supply of the tumor; repeat TACE deteriorates~     liver cirrhosis due to toxicity of chemotherapeutic agent to the parenchyma liver.~     Thalidomide has been reported to have antiangiogenic and antimetastatic effects. The~     objectives of adjuvant therapy with thalidomide for chemoembolization is to evaluate overall~     survival and time to progression.~   "
201762|NCT00921518|"~     Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in~     serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients~     following cardiac surgery, and at least 50% of patients with underlying renal insufficiency.~     Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk of~     developing post-operative AKI. The purpose of the current study is to determine if~     intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is~     effective at preventing post-operative AKI in patients with baseline kidney insufficiency and~     who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis is that~     an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic saline in~     reducing the incidence of post-operative AKI in cardiac surgery patients with a preoperative~     glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.~   "
201763|NCT00921505|"~     The purpose of this study is to determine whether paracetamol, ibuprofen or their combination~     can modify generation of radical oxygen species (ROS) from stimulated neutrophils.~   "
201764|NCT00921492|"~     Hypothesis The overall hypothesis is that non-obese (BMI <30) women with PCOS have high~     luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated~     low-frequency EA restore these alterations and induce ovulation.~   "
201765|NCT00921479|"~     The purpose of this study is to determine how quality of life changes after surgical removal~     of wisdom teeth~   "
201766|NCT00921466|"~     The proposed study is designed to evaluate the clinical contents of the e-SSRS-IVR with~     respect to 1.the intent of the instrument (assess face and content validity), 2. system~     validation with respect to programming integrity, 3. implementation feasibility in clinical~     ill and healthy patient populations, and 4. criterion/predictive validity to discriminate~     patient population with known clinical status differences.~   "
201767|NCT00921453|"~     Medical expert systems in combination with portal searching meta-search engines are exploited~     to provide reliable patient-tailored information. A prototype of a web-based information~     system has been developed and is to be evaluated. Its aim is to answer the decisive question~     whether expert system guided internet meta-search provides a better information supply for~     patients seeking health information online then this is possible by using ordinary search~     engines or health portals. The research does neither investigate the influence of ethical nor~     legal aspects of internet health information supply.~   "
201768|NCT00921440|"~     The investigators' rationale was to evaluate whether a 64-slice CT scanner allows accurate~     measurement of computed tomographic changes in coronary artery flow profiles and whether CT~     flow measurements are suitable for classifying the significance and hemodynamic relevance of~     a stenosis and thereby supplement as a functional parameter for morphological stenosis~     analysis.~   "
201769|NCT00921427|"~     The purpose of our study is to explore the efficacy of combination of brain stimulation with~     visual rehabilitation in patients with visual field loss resulting from brain lesions. It is~     shown that the effect of sensorimotor training of hand can be enhanced in patients with~     stroke using brain stimulation. We decided to explore this combination for visual field loss~     because visual dysfunction following brain lesions is considered intractable. We hypothesize~     that combination of noninvasive brain stimulation, in the form of transcranial direct current~     stimulation (tDCS), with visual rehabilitation would have greater efficacy than visual~     rehabilitation alone.~   "
201770|NCT00921414|"~     Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance~     therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment~     for mantle cell lymphoma and exhibiting a response after autologous transplantation.~   "
201771|NCT00921401|"~     It is important for people with asthma to become involved in their asthma care and~     management. This study will evaluate an interactive Web site that provides tailored feedback~     and information to asthma patients and encourages them to ask their doctor specific questions~     about their asthma care.~   "
201772|NCT00921388|"~     This research study is being done to find out if adding a moderate exercise program or a~     relaxation program to a smoking cessation treatment program will improve smoking cessation~     and health in postmenopausal women. We hope to learn which group is more successful at~     quitting, has less symptoms of withdrawal from smoking and has improved health.~   "
201775|NCT00921349|"~     The value of banding ligation plus beta blocker in the prophylaxis of first episodes of~     variceal bleeding has not yet been evaluated. This study was conducted to compare the~     efficacy and safety of banding ligation plus nadolol versus nadolol in the prophylaxis of~     first bleeding in cirrhotic patients with high-risk esophageal varices.~   "
201778|NCT00921310|"~     To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the~     combination of temsirolimus and pemetrexed, as well as the response rate. The starting dose~     (Dose Level 1) and schedule of pemetrexed will be 500 mg/m^2 given every 3 weeks and the~     starting dose (Dose Level 1) for temsirolimus will be 15 mg given weekly for 3 weeks, to~     complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment~     to each cohort is based on toxicity experienced at that dose level.~   "
201779|NCT00921297|"~     Two very common aging-related diseases in older adults are Alzheimer's disease (AD) and~     cataracts. In elderly adults, these two diseases frequently occur in the same person.~     Although a cure for AD is currently unavailable, cataracts can be effectively treated with~     surgery in most people. The removal of cataracts has documented benefits for visual~     performance and for reducing accidents and falls. However, it has been the experience of the~     ophthalmologists, and others in the field, that patients, caregivers, and primary care~     doctors are reluctant to proceed with cataract surgery once an individual is given the~     diagnosis of AD. It is thought that cataract surgery will not improve the AD patient's~     quality of life, vision, and cognition. The investigators have designed this study to~     determine whether or not this is true.~   "
201780|NCT00921284|"~     The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of~     propofol and remifentanil.~   "
201781|NCT00921271|"~     This study aims to determine how infrared spectroscopy compares to continuous compartment~     pressure monitoring in the detection of compartment syndrome.~      Individuals meeting the study eligibility criteria will be identified at time of admission by~     the receiving Trauma and Orthopaedics Registrar who will be trained in the study design and~     protocols.~      Eligible individuals will be approached about participating in the study either at time of~     admission or shortly afterwards, either by the chief investigator or another doctor trained~     in the research protocol. Where the individual is unconscious or otherwise incapacitated,~     which is likely in many major trauma victims, inclusion in the study will be discussed with~     the patient's legal representative and/or family.~      The consent process for the study will consist of having the study protocol explained by~     either the chief investigator, or another doctor trained in the study design. Patients will~     be allowed to read a participant information sheet, and permitted as much time as they~     require to decide if they wish to participate in the study. Verbal and written consent will~     be taken using a study specific consent form.~      In the case of incapacitated patients, the study design will be explained to their relatives'~     legal representatives as appropriate and advice sought from them as to whether they know of~     any reason why the patient might object to participate in the study. Upon regain capacity~     consent will be sought from the patient for storage and analysis of their study data.~      Once consented, the patient will undergo monitoring with both continuous compartment~     pressures, and NIRS measurements.~      Recordings for both techniques will be taken each hour, as part of the patients normal~     observations, from the point of consent until 24 hours after their first operation. Where~     patients do not have an operation the total duration of monitoring will be 24 hours. The~     measurements will be taken by nursing staff who have received training in both techniques.~     The procedure for each technique is described below:~        1. Continuous compartment pressures will be recorded in the broken leg, in case of tibial~          fractures, in all other patients fitting the inclusion criteria measurements will be~          taken from both legs (as both legs are at risk of compartment syndrome).~           Compartment pressures will be recorded using a slit catheter technique. Insertion of the~          slit catheter will be performed by either the chief investigator or Orthopaedic~          Registrar who will have been trained in the technique. The slit catheter is inserted~          using a sterile technique - the skin over the front outer part of the leg is cleaned and~          a catheter inserted into the anterior muscle compartment at this point. The catheter~          should be sited at the approximate midpoint of the leg, although this can be adjusted up~          or down if this would lead to insertion into a fracture site. The catheter is secured~          with a sterile dressing and connected to a monitor from which recordings can be taken,~          the catheter can be left in place for the duration of the study with no need to re-site~          it unless it stops recording accurately. At the same time as compartment pressure~          measurements are taken the patient's blood pressure will be monitored and the 'Perfusion~          Pressure' for the leg calculated, where:~           Perfusion pressure = diastolic blood pressure - leg compartment pressure~        2. NIRS measurements will be taken with an the INVOS system, produced by Somentics. These~          measurements will be taken from both legs, the affected leg and other other leg used as~          a control for comparison. Where both legs are at risk measurements will be taken from~          both legs and the midpoint of the forearm used as a control.~      The INVOS probe is a small adhesive patch that is stuck to the skin. The probe is sterile and~     will be attached using the same sterile technique as the compartment pressure catheter. Where~     the overlying skin is hairy the hair overlying the area for the probe should be clipped~     before attaching the probe, to ensure adequate adhesion and accurate readings. The probe is~     to be sited just below the compartment pressure catheter, although if there is an underlying~     haematoma (blood clot), then the probe should be positioned so at to avoid this but still~     remaining over the front outer part of the leg. This technique conforms with the~     manufacturers recommended use of the equipment and is similar protocol to previous studies.~      At the end of the monitoring period both measuring devices are removed. If the patient has~     developed compartment syndrome during this period and required an operation, the NIRS probe~     and compartment pressure catheter will be replaced for a further 12 hours of monitoring to~     monitor the changes post-operatively and ensure compartment pressures stay low.~   "
201782|NCT00921258|"~     This study concern a prospective cohort pf patients with latent prostate cancer. We study the~     specific survival at 10 years of patients who accept an active control.Patients inclusion are~     realized in 2 stages:~        -  patient with inclusion criteria (PSA < 10 ng/ml, clinical stage T1c or T2a, Gleason < or~          = 6) are registered if they accept a second prostate biopsy in a 3 months delay~        -  after analyse of second biopsy in central laboratory and confirmation of latent prostate~          biopsy, patients are included if they accept active control Included patients will have~          1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years.~      If progression of cancer happens during the 10 years control, active control will be stopped~     and patient will be treated by surgery and chemotherapy.~   "
201783|NCT00921245|"~     Patient perspective on Overactive Bladder and symptoms experienced after administration of~     Darifenacin~   "
201784|NCT00921232|"~     This study is about the patients life ending and their caregiver, when a return to home is~     planned.~      This is a behavioral sciences study (= interventional study for french law)~   "
201785|NCT00921219|"~     The purpose of this study was to compare the pharmacokinetic and bioavailability profile~     (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin~     solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken~     after a standard meal. The study is designed in accordance with the EU Note for Guidance on~     the Investigation of Bioavailability and Bioequivalence 2001.~   "
201786|NCT00921206|"~     The objective is to assess the humoral and cellular immune response of the VAX102 vaccine~     delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults~     against the influenza A virus M2e antigen after each vaccination.~   "
201787|NCT00921193|"~     The study aims to evaluate the safety and performance of the RTPS in patients with localized~     prostate cancer.The RTPS is an investigational device and requires permanent implantation of~     a small radioactive fiducial, called the Blip, in the prostate.~   "
201788|NCT00921180|"~     Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with~     HBeAg positive CHB, with the overall HBeAg seroconversion far from satisfactory. Therefore,~     efforts on the various combinations with the currently available drugs are needed to improve~     the overall response rates. The simultaneous combination therapy with oral nucleoside and~     peginterferon alfa-2a from large-scaled randomized trials did not show a superior response~     rate over peginterferon alfa-2a monotherapy. Recently, sequential monotherapy with lamivudine~     for the first 4 weeks, followed by weekly peginterferon alfa-2a has shown favorable HBeAg~     seroconversion rate over peginterferon alfa-2a monotherapy, based on the assumption that~     early viral suppression by lamivudine can restore the immune function to facilitate the later~     immunomodulatory response by peginterferon alfa-2a. With the recent introduction of~     entecavir, the more potent oral nucleoside with few drug resistance, sequential monotherapy~     with entecavir can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate~     the response of peginterferon alfa-2a to achieve HBeAg seroconversion. Therefore, we aimed to~     conduct a placebo controlled randomized control trial to evaluate of adding entecavir early~     in the course of therapy can improve the treatment response.~   "
201789|NCT00921167|"~     To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with~     recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme~   "
201790|NCT00921154|"~     The purpose of this study was to compare the pharmacokinetic and bioavailability profile~     (rate and amount of absorption into the bloodstream) of a test formulation of ivermectin~     solution 1 mg/ml with a marketed reference formulation of ivermectin 3 mg tablets when taken~     after an overnight fast .The study is designed in accordance with the EU Note for Guidance on~     the Investigation of Bioavailability and Bioequivalence 2001.~   "
201791|NCT00921141|"~     This is a prospective, descriptive and observational study of the anticancer center practice~   "
201834|NCT00920582|"~     The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead~     to greater reductions in insulin requirements in conjunction with near normal blood sugar~     control compared to placebo in patients recently diagnosed with type 1 diabetes.~   "
201835|NCT00920569|"~     This study is to test the usefulness of ultrasound dilution measurements in patients on~     extracorporeal membrane oxygenation. Measurements may include; efficiency of support~     (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well~     the heart is working (cardiac output). At the present time there are no devices available to~     perform these functions.~   "
201861|NCT00920231|"~     This is a feasibility study involving a small number of blind subject to evaluate the~     effectiveness of using a software and associated hardware components to assist the blind in~     identifying and locating objects of interests and to assist in way finding tasks. After the~     system has been successfully tested by the blindfolded engineers, it will be evaluated in a~     small number of blind subjects.~   "
201792|NCT00921128|"~     Background:~        -  Parkinson s disease (PD) is a progressive neurodegenerative disorder that affects the~          brain cells that make the chemical dopamine. The primary medical treatment for PD has~          been to use medications to replace the dopamine that is missing from the brain. These~          medications can be effective at first, but after many years side effects and tolerance~          develop.~        -  Surgery can treat basic PD symptoms and complications. Deep brain stimulation (DBS)~          offers a safer alternative as the therapy can be adjusted and reversed to minimize side~          effects and optimize beneficial effects. DBS treats the symptoms of PD but does not~          alter its course.~        -  Infusions of neurochemicals or medications are another PD treatment method. NIH~          researchers have developed the technique of convection-enhanced delivery, which very~          precisely and consistently delivers infusions of many types into the brain. This project~          will allow researchers to infuse a medication, Muscimol, into the subthalamic region of~          the brain to see if it is as safe and effective as DBS.~      Objectives:~        -  To determine whether an infusion of Muscimol into the brain is safe and relieves the~          symptoms of Parkinson s disease.~        -  To demonstrate that the infusion can be monitored with magnetic resonance imaging (MRI)~          using gadolinium.~      Eligibility:~        -  Patients 18 years of age and older who have Parkinson s disease and are preparing for~          bilateral subthalamic nucleus (STN) DBS surgery.~        -  Patients will be divided into two groups. One group of patients will have a partial~          infusion of Muscimol into the STN, and the second group of patients will have complete~          infusion of Muscimol into the STN.~      Design:~        -  This study will begin 5 days before the patient undergoes bilateral subthalamic DBS~          surgery.~        -  On Day 1 of the study, small thin tubes (microcatheters) will be inserted into the STN~          through the same incision and burr holes that are used for DBS. Two infusion studies of~          Muscimol will be performed on successive days: the first without PD medication (Day 3 of~          study) and the second with PD medication (Day 4 of study).~        -  Each infusion will be monitored in the MRI suite, and researchers will perform clinical~          examinations of patients PD symptoms.~        -  Following the study experiments, a second surgery will be performed to remove the~          microcatheters and to place DBS electrodes in the standard fashion.~   "
201793|NCT00921115|"~     This study is being done to test the safety and effectiveness of two drugs, Anastrozole and~     Fulvestrant, used as combined therapy in the neo-adjuvant setting for hormone receptor~     positive invasive breast cancer.~   "
201794|NCT00921102|"~     The aim of this study is to assess the efficacy of atropine in preventing nausea and vomiting~     after spinal anesthesia with local anesthetic and morphine for elective Caesarean section.~      Patients enrolling in the study will be assigned to one of three groups. One will receive a~     small dose of intrathecal atropine; another will receive small-dose intravenous atropine; the~     third group will receive placebo.~   "
201795|NCT00921089|"~     The aim of this cross-sectional study is to determine the correlation of coronary artery~     calcification as measured by electron-beam computerized tomography and coronary flow reserve~     measured by trans-thoracic Doppler echocardiography in hemodialysis patients. The~     investigators also assessed the carotid artery parameters by measuring intima media thickness~     that can accurately describe the process of arterial wall changes due to atherosclerosis.~     Possible association of coronary flow reserve with inflammation and arterial calcification in~     hemodialysis patients was also evaluated.~   "
201796|NCT00921076|"~     Surgical options for managing hindfoot arthritis include: joint fusion, total ankle joint~     replacement or osteotomies (realignment) of bones. Fusion of arthritic hindfoot joints has~     been the accepted method of managing hindfoot arthritis for over a century. Recently, total~     ankle replacement has evolved as a treatment option for patients with end stage ankle~     arthritis. A comparison of gait for patients before and after hindfoot fusion or total ankle~     replacement will give further information about the outcome of this treatment. The principal~     aim of this project is to assess the effect of total ankle replacement or hindfoot fusion on~     gait. We are also interested in the outcome of the surgery and its effect on your symptoms~     (eg. pain and mobility). The results of this study will aid researchers in assessing this new~     treatment modality. Your involvement in this study is critical for the researchers to further~     analyze this new form of treatment and your time and involvement is appreciated.~   "
201797|NCT00921063|"~     The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to~     placebo in the treatment of Generalized Anxiety Disorder in an adult population~   "
201798|NCT00921050|"~     Some recommendations of expert consensus on subclinical hypothyroidism (SH) are controversial~     in those areas with not enough information to reach a conclusion, such as not recommending~     treatment with thyrotrophic hormone of 4-10 mUI/L and free thyroxin in normal range. The body~     changes or symptoms at this stage are often mistaken as aging. There are studies showing~     significant changes in heart (slow rate, lower ejection fraction, diastolic dysfunction);~     hypercholesterolemia, dysfunction cognitive abilities (memory attention…).~      The prevalence of SH increases with age, reaching 14% over 65 years old. This age group~     increase as the population ages highlights the need for evidence to improve recommendations~     for the elderly.~      NEUROPSI is a validated neuropsychological test sensible for mild cognitive alterations. It~     can be applied to individuals with little schooling.~      This study aims to determine positive change in cognitive abilities (NEUROPSI), ejection~     fraction, and body percent of lean and adipose tissue without adverse effects, placebo versus~     thyroxin supplement to keep thyroid-stimulating hormone (TSH) between 0.5-2.5 mUI/L in~     elderly with TSH 4-10 mIU/L.~   "
201799|NCT00921037|"~     The purpose of this study is to determine whether multiple cutaneous neurofibromas in~     patients with neurofibromatosis type 1 can be removed with an erbium-YAG-laser.~   "
201800|NCT00921024|"~     The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and~     comparator in complicated urinary tract infection~   "
201801|NCT00921011|"~     The study hypothesis (or theory) is that monthly loss of iron before menopause may reduce~     women's risk of hardening of the arteries, or atherosclerosis.~      This study uses noninvasive, noncontrast magnetic resonance imaging (MRI) of arteries in~     women entering menopause. This will help to determine if there is a correlation between iron~     accumulation and hardening of the arteries. In addition, blood levels of hormones will be~     measured to help show differences due to hormone levels vs. iron accumulation.~   "
201802|NCT00920998|"~     To evaluate the effects of food intake on plasma concentration of Z-338 in healthy~     volunteers.~   "
201803|NCT00920985|"~     Birth Control Patch Study~   "
201804|NCT00920972|"~     The hypothesis for this study is that a preparative regimen that maximizes host~     immunosuppression without myeloablation will be well tolerated and sufficient for engraftment~     of donor hematopoietic cells. It is also to determine major toxicities from these~     conditioning regimens, within the first 100 days after transplantation.~   "
201805|NCT00920959|"~     To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and~     comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of~     age with asthma.~   "
201806|NCT00920946|"~     The purpose of this study is to determine if Dimebon is safe and effective for the treatment~     of cognitive impairment in Huntington disease.~   "
203083|NCT00904059|"~     The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and~     BMS-650032 when co-administered and when administered alone~   "
201808|NCT00920920|"~     Background:~      The standard treatment of locally advanced cervical cancer is radio-chemotherapy including~     external beam radiotherapy (EBRT), brachytherapy (BT) and concomitant chemotherapy with~     weekly Cisplatin. While image based conformal EBRT is routinely used, prescription and~     reporting of BT is still based on specific dose points defined in 2D. Thus, for several~     decades the BT dose has most often been prescribed and reported to the Manchester point A~     defined according to different traditions.~      Recently, a working group from GEC-ESTRO has published recommendations on contouring of~     tumour target and organs at risk (OAR) as well as on dose volume parameters to be reported~     for image guided BT in definitive radiotherapy for locally advanced cervical cancer. These~     recommendations are mainly derived from retrospective single institution experience with MRI~     based intracavitary BT. The major advantage of this technique is the possibility to conform~     the dose given by BT with regard to both volume (3D) and time (4D). Thus, by repetitive~     imaging performed before each BT implant it is possible adapt the dose given by BT to the~     anatomy of each individual patient taking into account not only the position of OAR but also~     the tumour regression which often is obtained by preceding EBRT and chemotherapy. Based on~     the experience collected so far, the image based BT approach is expected to have a major~     impact on the clinical outcome with a concomitant decrease in the rates of both local failure~     and morbidity.~      Aims:~        -  To introduce MRI based 3D-4D BT in locally advanced cervical cancer in a multicenter~          setting within the frame of a prospective observational study.~        -  To establish a bench-mark for clinical outcome with image based BT in a large patient~          population with respect to local control, survival, morbidity and QoL~        -  To establish a reference material with regard to image based DVH parameters according to~          the guidelines from the GEC ESTRO working group.~        -  To correlate image based DVH parameters for CTV and for OAR with outcome~        -  To develop prognostic and predictive statistical models for clinical outcome including~          volumetric, dosimetric, clinical and biological risk factors~        -  To establish radiobiological parameter estimates that will allow a precise risk~          estimation in individual patients and aid in the development of new treatment protocols~   "
201809|NCT00920907|"~     The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab~     manufactured by two different processes~   "
201810|NCT00920894|"~     This study aims to measure the effect of plant stanol esters on serum total and lipoproteins~     lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood~     lipid concentrations~   "
201811|NCT00920881|"~     To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring~     System with respect to a reference standard.~   "
201812|NCT00920868|"~     The primary purpose of this study is to find the highest tolerated dose of the study drugs:~     capecitabine, oxaliplatin, bevacizumab, and dasatinib given in combination to subjects with~     advanced solid tumors. This will occur in the first part of the study (Phase I). Once this~     dose has been determined, it will be given to subjects with advanced metastatic colorectal~     cancer in the second part of the study (Phase II).~      By giving these drugs in combination, researchers hope to evaluate the side effects of the~     study drugs in both groups, and to determine if this combination could possibly decrease or~     stabilize the cancer being treated.~      Subjects will be enrolled at Duke University Medical Center (DUMC) and Rocky Mountain Cancer~     Center.~      After satisfying eligibility and screening criteria, patients will be treated on 21 day~     cycles.~      ABOUT THE STUDY DRUGS~        -  Capecitabine (Xeloda™) is an oral (taken by mouth) chemotherapy drug in tablet form made~          by Roche Laboratories Inc. Capecitabine has been approved for use by the Food and Drug~          Administration (FDA) for first line treatment (treatment that should be used for cancer~          that has not been treated yet) of metastatic colorectal cancer and also for metastatic~          breast cancer.~        -  Oxaliplatin (Eloxatin™) is an intravenous (given by injection into a vein) chemotherapy~          drug made by Sanofi-Synthélabo. This drug is also approved by the FDA for use in~          metastatic colorectal cancer.~        -  Bevacizumab (Avastin™) is a type of intravenous cancer treatment called anti-angiogenic~          therapy (a type of therapy to treat cancer that interferes with blood flow to the tumor,~          thereby stopping tumor growth, and possibly leading to tumor shrinkage) made by~          Genentech Inc. Bevacizumab is approved by the FDA for first line treatment of metastatic~          colorectal cancer in combination with other chemotherapy.~        -  Dasatinib (Sprycel™) is an oral drug made by Bristol Myers Squib, Inc (BMS). Dasatinib~          is approved by the FDA for the treatment of chronic myeloid leukemia (CML), acute~          lymphoblastic leukemia or for patients that are resistant to a medicine called imatinib~          mesylate (Gleevec™ ).~   "
201813|NCT00920855|"~     The primary objective of this study is to assess the safety and tolerability of bendamustine~     as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma~     (MM).~   "
201814|NCT00920842|"~     RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors~     of childhood leukemia who have undergone stem cell transplant may help doctors learn more~     about the disease and the long-term effects of leukemia treatment. It may also help improve~     the quality of life for future cancer survivors.~      PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult~     survivors of childhood leukemia who have undergone stem cell transplant.~   "
201815|NCT00920829|"~     The overarching aim of this trial is to evaluate naltrexone's efficacy in light of genetic~     variation and brain response to alcohol cues utilizing a neuroimaging paradigm. This trial~     has four specific aims. First, this trial will evaluate whether the presence of the OPRM1~     Asp40 allele substitution is associated with improved treatment response to naltrexone in~     treatment-seeking alcoholics. Second, it will evaluate whether there is a difference in the~     naltrexone dampening of the alcohol cue-induced brain activation dependent on OPRM1 genotype.~     Third, it will explore whether alcohol cue-induced brain activation dampening by naltrexone~     might be a mediating factor in the treatment effects of naltrexone, the OPRM1 gene, or their~     interaction that might be observed in the first aim. Finally, this trial will evaluate the~     effect of medication compliance, or adverse effects, on the observed medication by genotype~     treatment response. A secondary aim will measure medication compliance and side effects based~     on OPRM1 genotype.~   "
201816|NCT00920816|"~     The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in~     delaying tumor progression in patients with metastatic renal cell cancer.~   "
201817|NCT00920803|"~     The primary purpose of this study is to determine the safety and tolerability of SRT501 (5.0~     g) in subjects with colorectal cancer and hepatic metastases when administered once daily for~     14 days.~      The purpose is to also characterize the pharmacokinetic profile of SRT501 (5.0 g) by~     assessing levels of SRT501 and metabolites in blood, urine, bile and normal and malignant~     metastatic tissues in subjects with colorectal cancer and hepatic metastases when~     administered once daily for 14 days.~      The secondary purpose is to examine the pharmacodynamics of SRT501 activity in both normal~     and malignant tissue samples, including blood and/or bodily fluids.~   "
201818|NCT00920790|"~     To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761, the anti-CC~     chemokine receptor 4 (CCR4) antibody, when administered weekly for 8 weeks as an intravenous~     infusion at a dose of 1.0 mg/kg in relapsed subjects with CCR4-positive adult T-cell~     leukemia-lymphoma.~   "
201819|NCT00920777|"~     The purpose of this study is to analyze income variables in Chronic Fatigue Syndrome/Myalgic~     Encephalomyelitis, and to analyze the effect of short vs. long Cognitive Behaviour Therapy.~   "
201820|NCT00920764|"~     The study objective is to investigate the effects of three low doses of atrasentan on urinary~     albumin/creatinine ratio (UACR) levels in subjects with Type 2 diabetic nephropathy.~      Patients with Type 2 diabetes with nephropathy must be receiving a renin-angiotensin system~     inhibitor, such as an Angiotensin converting enzyme inhibitor (ACEi) or an Angiotensin II~     Receptor Blocker (ARB) for participation in this study. ACEi and ARB treatment are the~     standard of care for the management of proteinuria in Chronic Kidney Disease (CKD) patients.~   "
201821|NCT00920751|"~     Hypothesis~        1. Study method achieves lower requirement for medications~        2. Study method increases overall cecal intubation with comparable assessment of current~          experience and patient willingness to repeat future colonoscopy compared with~          conventional colonoscopy~        3. Study method results in reduction in medication-related (cardiorespiratory)~          complications, faster turn around of patients, compared with conventional colonoscopy~        4. Study method improves bowel preparation and increases polyp pickup rate~      Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic VA~     patients is being promoted (VHA directive). Compliance with this Directive will result in an~     increased number of VA patients undergoing colonoscopy. The demand for colonoscopy far~     exceeds the capacity available to perform the procedure in the VA system. The conventional~     practice for colonoscopy at VA facilities across the country is to perform colonoscopy under~     conscious sedation with air insufflation. Efficiency is governed by the fact that sedated~     patients require time and space for recovery and these are major limiting factors in the~     current setting for the use of colonoscopy for CRC screening.~      Methods that maintain a high success rate and good patient assessment improve overall~     compliance for surveillance colonoscopy. Our preliminary experience showed that patients are~     able to complete successful colonoscopy without sedation in 52% of cases when colonoscopy was~     aided by a water infusion in lieu of air insufflation method. In this group of patients, the~     shortened recovery time means a quick turn around of patient and a more efficient endoscopy~     service. Patients are able to communicate better with the staff and physician regarding their~     problem and discharge instructions, and not subjected to the amnesic effect of sedation. Next~     day follow-up of patient by telephone contact which requires commitment of staff time can be~     obviated.~      If this randomized study confirms the success of our preliminary findings and this technique~     is adopted by more endoscopists, a larger number of VA patients may benefit from less~     sedation complications and at the same time allow for more efficient colonoscopy screening~     services.~   "
201822|NCT00920738|"~     RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors~     of childhood cancer may help doctors learn more about the disease.~      PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer~     and in their healthy sisters and brothers.~   "
201823|NCT00920725|"~     The purpose of this study is to determine whether insulin administered by a subcutaneous~     injection is effective in the treatment of a diabetic crisis and to determine if~     beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.~   "
201824|NCT00920712|"~     The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription~     Weiqi decoction on Chronic Atrophic Gastritis.~   "
201825|NCT00920699|"~     To establish the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10~     in pre-manifest participants carrying the CAGn expansion for Huntington's Disease (HD).~   "
201826|NCT00920686|"~     NXN-188 Dihydrochloride is being developed as an immediate release oral product for the~     treatment of acute migraine. This study is being conducted to evaluate NXN-188 in subjects~     with a migraine history of aura.~   "
201827|NCT00920673|"~     In pediatric anesthesia and in pediatric intensive care, tracheal intubation is one of the~     most important procedure. To achieve this procedure as fast as possible and in is best~     conditions, the physician should choose the head posture which a priori will enable at first~     the best glottic visualisation during laryngoscopy, and at second will facilitate the route~     of the tube from the larynx to the trachea.~      Tracheal intubation is a procedure used for years, and many textbooks recommendations on the~     best head posture for tracheal intubation in paediatrics have been made. Briefly summarized,~     depending on the age of the child, the head should (or not) be slightly extended, and a~     pillow should (or not) be positioned under the occiput. These recommendations are~     questionable for three majors reasons:~        -  despite an apparent consensus, some recommendations are quite different.~        -  none are based on anatomical nor clinical studies~        -  if for all of them, the age of the child is considered as critical point, but children~          are only grossly categorized in three categories (newborn, infants and old children).~          And the clinician has no way, facing a child, to make his choice between dichotomic~          attitudes.~      Actually, the responses to these questions should need rigourous clinical studies on~     laryngoscopy, hard to design and very difficult to make. P.Adnet et coll. (Anesthesiology~     2001) showed that an anatomical study with resonance magnetic imaging (MRI) can bring~     indirect but strong evidence and can be a first step leading to clinical studies. Many~     children need MRI study for different reasons, and it is fast and easy to get during their~     examination additional images of the superior airway.~      In their unit, the investigators are experienced in this kind of study, as they recently~     published (Pediatric Anesthesia 2008) an MRI study demonstrating that in children, head~     extension improves the alignment of the visualisation axis on the laryngeal axis, but worsens~     the alignment of the pharyngeal axis on the laryngeal axis. However, patients included in~     their study were in major part infants, so the influence of the age could not be properly~     analyzed. Morevover, this study suffered of two main limitations, the lack of standardisation~     of head postures, and that a laryngeal mask the children, who were on general anesthesia~     (required for the MRI examination) were made using a laryngeal mask (as it was at this time~     the standard in their institution).~      The investigators propose an MRI study of the influence of age on the consequences of head~     extension on the anatomic axes of the superior airway in children, with a prospective~     stratified on age study. Several modifications and improvement in the design of this study~     would diminished the limitations of the first study.~   "
201828|NCT00920660|"~     The primary purpose of this study is to assess the pharmacodynamic effect of single, oral~     doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) and prednisolone as measured by levels of~     ex vivo LPS-induced TNF-alpha production in whole blood of healthy adult subjects.~      The secondary purposes of this study are to assess the pharmacodynamic effects of single,~     oral doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) and prednisolone (30mg) as measured~     by levels of IL-6, IL-8 and IL-1beta in whole blood of healthy adult subjects. In addition,~     plasma pharmacokinetics, safety and tolerability of SRT2104 following the administration of~     single, oral doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) in healthy adult subjects~     will also be assessed. As exploratory endpoints, transcriptomic profiles, biomarker~     exploration, and relationships between plasma SRT2104 levels and ex vivo LPS-induced~     TNF-alpha production may also be examined.~   "
201829|NCT00920647|"~     Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain~     barrier at therapeutic levels when administered intravenously. A new formulation of~     idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation,~     Elaprase, has been developed to be suitable for delivery into the cerebrospinal fluid (CSF)~     via intrathecal administration.~      This Phase I/II study is designed to obtain necessary safety and exposure data, as well as~     secondary and exploratory outcome measures, to be interpreted and used in the design of~     subsequent clinical trials.~   "
201830|NCT00920634|"~     The main purpose of this investigation is to collect information about safety and efficacy of~     Follistim Injection from actual clinical use to induce ovulation in patients with anovulation~     and oligoovulation due to hypothalamus-pituitary dysfunction.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
201831|NCT00920621|"~     Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and~     children.~   "
201832|NCT00920608|"~     The main aim of this clinical study is to investigate whether the blood concentration of~     methotrexate changes when AZD9056 is co- administered together with methotrexate.~   "
201833|NCT00920595|"~     An open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of~     CEP-9722 as single-agent therapy and as combination therapy with temozolomide in patients~     with advanced solid tumors.~   "
203393|NCT00899847|"~     To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant~     approach for patients with advanced stage multiple myeloma.~   "
201836|NCT00920556|"~     The primary purpose of this study is to determine the safety and tolerability of SRT501 (5.0~     g) with or without concurrent bortezomib administration, when administered once daily in 21~     day cycles, in male and female subjects with Multiple Myeloma.~      The purpose is also to define objective response (ORR, CR, PR, MR, SD) and time to~     progression (TTP) of SRT501 with or without concurrent bortezomib administered concurrently~     in male and female subjects with Multiple Myeloma.~      In addition, 15 subjects will participate in a sub-study to assess the pharmacokinetics of~     SRT501.~   "
201837|NCT00920543|"~     The purpose of this study was to determine whether asthma control and reduced bronchial~     hyperresponsiveness could be achieved and maintained at a lower dose of inhaled~     corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent~     subjects with persistent asthma~   "
201838|NCT00920530|"~     Group B streptococcus infections may be serious for the neonates. The infection can occur~     during the birth, by contact with the genital area. That is why the detection of this~     bacteria is systematically realised in pregnant women between 34 and 37 weeks of amenorrhea~     in order to give prophylactic antibiotic treatment in case or positive carriage. This~     strategy presents 2 disadvantages : (1) detection of the group B streptococcus at 34 and 37~     weeks of amenorrhea in not predictive of a carriage at delivery, (2) many pregnant women~     escape from systematic screening, leading to a systematic antibiotic treatment, which means~     useless costs, and useless antibiotic exposure with resistant bacteria selection. Real time~     polymerase chain reaction (PCR) allows a rapid detection anytime with no specific~     microbiological qualification. The aim of the study is to assess the economic outcomes of~     this strategy and the epidemiological values for St Etienne hospital.~   "
201839|NCT00920517|"~     Dengue fever, caused by dengue viruses, is a major health problem in the tropical and~     subtropical regions of the world. The purpose of this study is to test the safety of and~     immune response to a new dengue virus vaccine in healthy adults.~   "
201840|NCT00920504|"~     The purpose of this pilot study is to refine and test an advanced and adapted German version~     of the PRO-SELF© Plus Pain Control Program (PCP), an educational intervention directed at~     cancer pain patients and their families to enhance their pain self management abilities, and~     to calculate effect sizes for the planning of a sufficiently powered randomized controlled~     trial (RCT).~   "
201841|NCT00920491|"~     Patients presenting to emergency departments (ED) with non-specific complaints (NSC) such as~     not feeling well, feeling weak, being tired, general deterioration are a very common~     and well-known, but poorly studied patient group. The differential diagnosis of NSC is~     extremely broad ranging from insufficient home care to acute life-threatening conditions.~     Therefore, the evaluation and diagnostic work-up of these mostly elderly patients with NSC is~     very time-consuming and not straight-forward. Furthermore, the assessment is complicated by~     comorbidities, polypharmacy or an altered mental status. For this reason, potentially~     unnecessary diagnostic efforts are undertaken in order to exclude a serious underlying~     condition, leading to prolonged throughput times and ED observation unit stays.~      On the other hand, the patients` condition might be underestimated by ED physicians, which~     may result in ineffective, delayed or inadequate disposition, as well as poor patient~     outcomes. BANC (formerly BAUCAS) is a series of clinical studies with the intention to~     investigate the usefulness of clinical findings and biomarker levels combined for disposition~     of patients with non-specific complaints presenting to the emergency department.~   "
201842|NCT00920478|"~     Patients with rheumatoid arthritis are at risk of developing permanent joint damage and~     disability. This study hopes to identify the most effective way of using existing arthritis~     medication to minimise the chances of developing permanent disability. Patients will have~     their arthritis activity assessed using an ultrasound machine. If there is still evidence of~     active arthritis the participant's arthritis medication will be increased until the arthritis~     is in remission. The effectiveness of this approach will be compared to the traditional~     method of assessing arthritis using clinical examination.~      Furthermore, it is extremely important to identify those patients most at risk of aggressive~     disease. The investigators hope to produce a more accurate measurement of disease prognosis~     by examining the relationship between a series of blood tests and how well controlled~     rheumatoid arthritis appears after 18 months of therapy. Some patients will also be asked to~     donate samples of joint fluid and joint lining for additional analysis.~   "
201843|NCT00920465|"~     The purpose of this study is to test two regimens of mifegyne and cytotec for medical~     abortion. The investigators hypothesize that administration of both medications during one~     hospital visit will not compromise effectiveness.~   "
201844|NCT00920452|"~     The purpose of this study is to evaluate and document appropriate clinical performance of the~     new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable~     cardioverter defibrillator (ICD) PGs (Models F103; F111), the COGNIS 100 HE 4-SITE cardiac~     resynchronization therapy ICD (CRT-D) PG (Model P108) when connected to any of the RELIANCE~     Quadripolar (4-SITE) defibrillation leads.~      Appropriate clinical performance of system components of the 4-SITE systems other than the~     new 4-SITE header / lead interface has been evaluated and documented already in the~     previously conducted COGNIS and TELIGEN 100 HE FIELD FOLLOWING STUDY, The COGENT-4 Field~     Following Study.~      Data collected may be used to support international regulatory submissions including the FDA~     and the Japanese Ministry of Health, Labour and Welfare.~   "
201845|NCT00920439|"~     The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster~     dose to Chinese children at 18-24 months of age.~   "
201846|NCT00920426|"~     The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and~     how well it works on reducing the amount of HIV in the blood. It will also look at how people~     react to and how a human body uses GSK1265744. This study will compare the effects of~     GSK1265744 and placebo.~      The study will consist of 1 or 2 parts to look at doses of GSK1265744. About 8 people will~     take part in Part 1 of the study receiving dose A. If additional dosing information is needed~     after Part 1, about 6 people will take part in Part 2 of the study receiving dose B.~   "
201857|NCT00920283|"~     The COMPETE study is a prospective,randomized,two-arm multi-center clinical trial comparing~     two commercially available coronary stents: Chrono Carbostent Carbofilm™ Coated vs~     Driver/Micro-Driver Coronary Stent System. In this study, 204 subjects will be included (2:1~     randomization Chrono:Driver/Micro Driver) in 6 Italian sites.~   "
201847|NCT00920413|"~     People with kidney failure are at risk for the development of anemia. Anemia is a decrease in~     the production of hemoglobin, a substance that carries oxygen in the blood. The majority of~     patients require erythropoietin and iron supplementation to correct the anemia. In some~     patients, the hemoglobin fails to rise to a desired level despite treatment with~     erythropoietin and iron. There have been several studies in hemodialysis patients showing~     that vitamin C given intravenously helps to correct anemia in patients already on~     erythropoietin and iron.~      The purpose of this study is to determine whether oral vitamin C will improve parameters of~     anemia in patients receiving peritoneal dialysis.~      Description of the research~      This is a randomized, double blind, placebo controlled study. Participants will be randomized~     in a 1:1 ratio to oral vitamin C 500mg once a day or placebo for 3 months. All participants~     will be receiving oral iron supplementation, subcutaneous erythropoietin and a B and C~     complex vitamin containing 100mg of vitamin C. Lab parameters (hemoglobin, TSAT, ferritin)~     will be done at baseline and then monthly. The primary outcome is percent change from~     baseline in transferrin saturation. Secondary objectives are percent change in ferritin,~     hemoglobin and erythropoietin dose from baseline.~   "
201848|NCT00920400|"~     Fecal calprotectin is a very sensitive non-invasive inflammation marker in the detection of~     inflammatory bowel disease and, to a lesser degree, has also proven to be useful in~     adenomatous polyps, neoplasias, and infectious gastroenteritis. Elevated calprotectin levels~     can also be found in patients with lesion only in the upper gastrointestinal tract. However,~     the diagnostic value of calprotectin has never been tested in this setting. The aim of the~     study is therefore to determine the diagnostic value of fecal calprotectin in patients with~     diseases of the upper gastrointestinal tract.~   "
201849|NCT00920387|"~     This study will find out whether psychotherapy combined with lysergic acid diethylamide (LSD)~     is safe and is helpful in people who are anxious because they have a potentially fatal~     disease. The study will measure anxiety and quality of life before and after people have two~     sessions with either full or active placebo dose of LSD. They expect LSD-assisted~     psychotherapy to reduce anxiety and improve quality of life.~   "
201850|NCT00920374|"~     This study is designed to test the immunogenicity and reactogenicity of the~     FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for~     the 2009-2010 season.~   "
201851|NCT00920361|"~     To evaluate dosage and administration method, efficacy and safety of Puregon and the~     relationship between background factors of patients and dose and administration method.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
201852|NCT00920348|"~     Abstract Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in~     Canada. COPD is not just a disease of men, nor is it solely a disease in old age. Women have~     been underrepresented and early disease has not been studied. Underdiagnosis of COPD remains~     a significant problem, and it may indicate an unmet healthcare need. This can potentially~     results not only in a patient been misinformed, but can lead to incorrect management.~      Epidemiological research is needed to develop a framework to combat this major health~     problem, by better characterization of the population of men and women at risk and patients~     with early disease, by better understanding which factors modifiable through health~     interventions are related to health perception (health-related quality of life) and disease~     evolution.~      This will be possible through a nationwide study, the Canadian Cohort Obstructive Lung~     disease (CanCOLD), a prospective longitudinal study. The CanCOLD study is built on the~     current ongoing prevalence nationwide study, the Canadian Obstructive Lung disease COLD~     study.~      The CanCOLD will be the first study to assess prevalence of disease across Canada and its~     consequence in men and women, and to evaluate a conceptual model of disease severity based on~     patient's health perception (health-related quality of life). Ultimately, this project will~     extend to a longitudinal follow up (3 years or beyond) and will allow to have a better~     understanding of the lifestyle risk factors, not only smoking but also diet, physical~     activity, and co morbid conditions. This will be a great asset to shift from management of a~     single risk factor (tobacco control) to total COPD risk management. The results of the study~     will greatly help to assist decision makers in developing policies to improve the diagnosis,~     the management of COPD and to optimize health care services use.~   "
201853|NCT00920335|"~     Adult intracranial ependymoma is a relatively rare brain tumour entity, accounting for 2-5%~     of all intracranial neoplasms. The pertinent prognostic factors as well as the pattern of~     recurrence remain to be elucidated. According to several recent reports, the prognostic value~     of Karnofski performance status, tumour location, the extent of surgical removal,~     histological grade and even postoperative radiotherapy remain controversial. As a~     consequence, optimal therapeutic management of adult intracranial ependymomas remains an~     ongoing debate. For this reason, a retrospective study conducted by the French society of~     neurosurgery (SFNC), neuropathology (SFNP) and the association of the neuro-oncologists of~     French expression (ANOCEF) was undertaken and allowed to collect 258 cases coming from 25~     centers, initially diagnosed as intracranial ependymomas between 1990 and 2004. Clinical and~     follow-up data of these patients are known and the paraffin embedded samples as well as the~     frozen tissues available have been centralized. Central pathological review of these 258~     cases was conducted by two senior neuropathologists and confirmed the diagnosis of ependymoma~     in 152 cases, thus constituting the most important series of the literature. Few molecular~     studies were carried out on ependymomas. The investigators have the opportunity, based on~     this important series, to determine the clinicopathological criteria and the molecular~     markers who will allow a better characterization of the diagnosis and the prognosis of these~     tumors.~   "
201854|NCT00920322|"~     This study will report on the outcomes of rTMS administered 3 times per week, compared with~     the standard protocol of 5 times per week. Participants will be randomly assigned to~     frequency condition and depressive symptomatology will be measured weekly using a range of~     clinician and self-rated questionnaires. Participants will remain in the study for at least 4~     weeks, with the option of continuing for a further 2 weeks as judged by the study~     psychiatrist. It is hypothesised that rTMS administered three times per week will be equally~     as effective as rTMS administered five times per week in reducing depressive symptomatology.~   "
201855|NCT00920309|"~     Currently the only approved use for rapamycin (sirolimus) is for immunosuppression after~     renal transplantation.~      This trial is designed to determine whether rapamycin is safe and effective treatment for~     patients with polycystic kidney disease (ADPKD). Patients will be followed by volumetric~     magnetic resonance imaging (MRI) to observe for change in kidney (and cyst) size. Blood and~     urine samples will also be collected to evaluate for change in biomarkers with treatment.~   "
201856|NCT00920296|"~     The primary objective of this study is to compare steady-state plasma PK, safety and~     tolerability of GSK1265744 with and without etravirine~   "
201863|NCT00920205|"~     The purpose of this study is to see how safe the study drug is and to determine the best dose~     to use in cancer patients in the future.~      The study drug is designed to reduce the activity of a protein known as heat shock protein~     90, or Hsp90. Hsp90 is found in every cell in the human body and normally helps those~     cells (and the body) cope with stressful situations. In certain cancers, however, Hsp90 helps~     the cancer cells survive and grow. By reducing the activity of Hsp90, the study drug may slow~     the growth, and reduce the survival, of those cancer cells.~   "
201864|NCT00920192|"~     The purpose of this study is to assess the safety and tolerability of foretinib (also known~     as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma~     (liver cancer).~   "
201865|NCT00920179|"~     Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for~     the study of glandular architecture and functions are limited and include analysis of tear~     constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and~     histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new~     emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment~     of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study~     of the microscopic morphology of the salivary/lacrimal glands have not been reported up to~     date. In this study, we employ laser scanning confocal microscopy to evaluate the~     morphological changes of the salivary/lacrimal glands in patients with primary Sjögren's~     syndrome and compare the results with those of healthy control subjects.~   "
201866|NCT00920166|"~     The purpose of the study is to assess growth and tolerance in new born and infant fed an~     experimental infant formula with reduced total protein concentration, enriched in~     alpha-lactalbumin and containing a symbiotic.~   "
201867|NCT00920153|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving drugs in~     different combinations may kill more cancer cells. It is not yet know which treatment regimen~     is more effective in treating Hodgkin lymphoma.~      PURPOSE: This phase III trial is studying three different therapy regimens to compare how~     well they work in treating patients with previously untreated Hodgkin lymphoma.~   "
201868|NCT00920140|"~     MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended~     dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with~     relapsed or refractory leukemias. The recommended dose and regimen will be selected based on~     the safety, pharmacokinetic, and pharmacodynamic profiles. This study will identify the~     maximum tolerated and recommended Phase II doses using a dose-escalation procedure. Dose~     escalations will continue based on predefined parameters until a maximum tolerated dose is~     established. In Phase II, the clinical efficacy of GSK1120212 in subjects with relapsed or~     refractory leukaemias (AML, MDS or CMML) will be determined.~   "
201869|NCT00920127|"~     Obstructive airways disease is a very common condition. This condition includes patients with~     asthma, chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis. Some~     patients with obstructive airways disease have problems with long term breathlessness, wheeze~     and cough with or without sputum production. Currently the researchers give treatments -~     usually inhalers - which are designed to open the airways and reduce the breathlessness and~     wheeze. Despite these available treatments many patients still have continuing symptoms.~      Anecdotal clinical evidence suggested that a herbal remedy (called AKL1) has beneficial~     effects in respiratory conditions, with patients diagnosed as having both asthma and COPD~     reporting reduced symptoms including breathlessness and cough and reduced frequency of~     attacks.The purpose of this study is to confirm whether AKL1 does indeed have a meaningful~     benefit to patients with obstructive airways disease. The researchers will mainly be~     measuring any effect of AKL by assessing any change in trial subjects' coughs, using a~     questionnaire, but the researchers will also looking at breathing tests, walking tests, blood~     and sputum tests.~   "
201870|NCT00920114|"~     Lupus erythematosus systemic is an auto-immune disease the evaluation of the activity of~     which remains very difficult because of an heterogeneousness of the clinical and biological~     symptoms. The aim of this study is to develop objective, specific and not invasive methods of~     evaluation of the activity and the forecast of the disease by using an analysis of the~     transcriptome on circulating blood. A transcriptomic analysis will be realized in parallel by~     the usual clinico-biological follow-up at the patients affected by systemic lupus, while the~     diagnosis before treatment, then during every revaluation of the disease during the period of~     the study. The already treated patients can also be included in this study.~   "
201871|NCT00920101|"~     The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin~     attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG)~     PET.~   "
201872|NCT00920088|"~     The purpose of this study is to evaluate the effect of GSK2448761 on CYP450 metabolic probes~     and to evaluate the 2-way interaction between GSK2448761 and two ritonavir-boosted protease~     inhibitors that are commonly used in HIV-infected subjects.~   "
201873|NCT00920075|"~     The investigators earlier have shown that treatment of patients with juvenile osteoporosis~     with alendronate (Fosamax) for 12 months increased the bone density without side effects. In~     an open label study (10 patients) and double blind, crossover study (11 patients alendronate~     and 11 patients placebo), the investigators have further observed that alendronate increased~     the bone density significantly where as placebo (calcium and vitamin D) increased only~     minimally. These trials were completed. Thus, a post study is designed to evaluate the~     current status of the bone density and fractures after the patients discontinued the~     alendronate treatment. No treatment is involved.~   "
201874|NCT00920062|"~     This study is to test the usefulness of ultrasound dilution recirculation measurements in~     patients receiving venovenous extracorporeal membrane oxygenation as therapy. The ultrasound~     dilution measurements determine the efficiency of support provided by venovenous~     extracorporeal membrane oxygenation. At the present time there are no other devices available~     to make recirculation measurements.~   "
201921|NCT00919425|"~     RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer~     to study in the laboratory may help doctors learn more about diagnosing cancer and how well~     patients will respond to treatment.~      PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from~     patients with hematologic cancer to be tested in the laboratory.~   "
201875|NCT00920049|"~     Background:~        -  Automobile crash risks are highest right after licensure and decline rapidly for about 6~          months and then gradually for years, regardless of the amount of supervised practice~          driving or age at licensure. The only approaches to this problem that have demonstrated~          effectiveness are Graduated Driver Licensing (GDL) and parental management.~        -  The Checkpoints Program consists of persuasive messages and materials designed to~          increase adoption of the Checkpoints Parent-Teen Driving Agreement and to improve~          parents' ability to set limits on higher-risk driving privileges for novice drivers.~          Researchers are interested in determining whether expanding the Checkpoints Program to~          an online version (instead of through the mail) can help improve parent limit-setting in~          connection with the program.~      Objectives:~        -  To determine the feasibility and effectiveness of conducting an online version of the~          Checkpoints Program through American Automobile Association (AAA) clubs.~        -  To test rates of parental intervention and limit-setting after participation in the~          Checkpoints Program.~      Eligibility:~      - Parents whose teenage children are enrolled in AAA-affiliated driving schools.~      Design:~        -  Parents with children at the permit stage of driver's education will be recruited~          through AAA clubs and will be asked to visit a designated Web site to sign up for the~          program.~        -  Parents will provide consent and complete the baseline survey, and will be assigned to~          random groups to test different versions of the Checkpoints Program (the intervention or~          a control group Web site).~        -  The intervention program will contain videos, regular e-mails, and newsletters on~          setting parental limits and information on specific teen driving risks. The control~          program will provide information on various topics related to the licensing procedure~          and safe driving, but no specific information on teen driving risks.~        -  A follow-up assessment will be conducted 1 month after the teenager receives his or her~          license.~   "
201876|NCT00920036|"~     Objective:~      The aims are to examine the feasibility and acceptability of a handheld biofeedback device as~     an adjunct treatment for Post Traumatic Stress Disorder (PTSD) and to estimate its clinical~     effect size. A recent summary of 22 studies on OIF/OEF (Operation Iraqi Freedom/Operation~     Enduring Freedom) veterans revealed that many individual and system factors (e.g., stigma,~     concern about promotion/employment, lack of providers) prevented access to mental health~     services. For veterans who did seek help, the largest treatment trials of pharmacologic,~     outpatient psychotherapy, and residential treatment programs were not very effective.~     Currently, prolonged exposure therapy is the most validated PTSD treatment. The VHA enrollees~     from OIF/OEF are more likely to live in rural areas, hindering them from pursuing treatment~     due to travel distance and time commitment. Thus, new treatments and delivery methods are~     urgently needed.~      A substantial body of preclinical literature documents autonomic nervous system (ANS)~     dysregulation in patients with PTSD. Preliminary results suggest that portable heart rate~     variability (HRV)/respiratory sinus arrhythmia (RSA) biofeedback is a promising adjunct~     treatment for autonomic arousal disorders. The StressEraser, a HRV/RSA biofeedback device, is~     indicated for relaxation, relaxation training, and stress reduction. This small handheld~     device measures and displays real-time RSA via an infrared finger sensor.~      Research Plan:~      The investigators were able to randomize 16 OIF/OEF veterans receiving care for PTSD at CAVHS~     community-based outpatient clinics (CBOCs) to a 24-week course of StressEraser use (N=8)~     versus usual care (N=8). A trouble-shooting phone call to participants occurred at 6 weeks.~     Follow-up clinical assessments occurred at 12 and 24 weeks.~      Methods:~      The baseline assessment consisted of a screening interview for comorbid anxiety and substance~     use disorders, the Clinician Administered PTSD Scale (CAPS), the 9-item depression Patient~     Health Questionnaire (PHQ-9), and a quality of life measure (Quality of Well-Being Scale-Self~     Administered [QWB-SA]). In addition, psychophysiologic assessment of reactivity and~     attentional bias to combat-related PTSD relevant stimuli occurred through virtual reality~     (VR) and acoustic startle stimuli at the North Little Rock psychophysiologic reactivity lab.~     The StressEraser group was trained to operate the device at baseline and instructed to use it~     for 5-20 minutes daily before bedtime for 24 weeks.~      At six weeks, a research assistant phoned the StressEraser group to address any problems with~     the device and the usual care group to insure adherence with ongoing treatment. The 12-week~     assessment involved phoning both groups to administer the psychometric measures (CAPS, PHQ-9,~     and QWB-SA). At 24 weeks, the sample returned to the lab for administration of the~     psychometric measures and assessment of psychophysiologic reactivity.~      The subjects in the StressEraser group returned the device. The time spent using the~     StressEraser and the total number of resonant frequency respirations were the feasibility~     measures. The StressEraser logged the date, time, and duration of use and the amount of~     resonant frequency breathing, which is the resonance between the respiratory and baroreflex~     rhythms, the two primary sources of cardiac stimulation. Acceptability was measured through a~     short debriefing interview.~   "
201877|NCT00920023|"~     The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall~     Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an~     FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise~     undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for~     surgical resection.~   "
201878|NCT00920010|"~     RATIONALE: Collecting and storing samples of tissue, blood, and sputum from patients with~     cancer to study in the laboratory may help the study of cancer in the future.~      PURPOSE: The purpose of this study is to collect and store tissue, blood, and sputum samples~     from patients with lung cancer to be tested in the laboratory.~   "
201879|NCT00919997|"~     RATIONALE: Gathering information about human papilloma virus (HPV) infection in HIV-positive~     men who have sex with men may help doctors learn more about the disease.~      PURPOSE: This clinical trial is studying HPV infection in HIV-positive Indian men who have~     sex with men.~   "
201880|NCT00919984|"~     Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy~     is recommended for all patients with advanced ovarian cancer.~      Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy.~      Recently, intraperitoneal combination chemotherapy has been reported to be effective in~     ovarian cancer.~      We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel +~     carboplatin plus intraperitoneal paclitaxel chemotherapy.~   "
201881|NCT00919971|"~     To evaluate the effectiveness of use of the bispectral index for monitoring of depth of~     sedation in ventilated patients during their prehospital management by a physician- staffed~     EMS. Hypothesis: there is a correlation between BIS and sedation scores.~   "
201882|NCT00919958|"~     The The purpose of this study is to determine the safety of PLX-PAD single dose,~     Intra-muscular injection for the treatment of CLI patients.~   "
201883|NCT00919945|"~     The objective of this study is to determine the impact of early post-operative feeding on~     splanchnic blood flow, cardiac output and end organ perfusion, and the patients overall~     clinical outcomes.~   "
201884|NCT00919932|"~     The primary goal of the pilot is to test the feasibility and utility of using a~     text-messaging system to engage adolescents in improved homework adherence during~     cognitive-behavioral therapy (CBT) for major depressive disorder.~   "
201885|NCT00919919|"~     The objective of the study is to confirm that the efficacy of vaginal progesterone is at~     least as good as oral progesterone in order to protect the endometrium of uncontrolled~     proliferation and prevent endometrial cancer.~   "
201886|NCT00919906|"~     This study will assess whether a computer haptic peripheral device programmed to provide~     repetitive motion training is as effective as the same repetitive motion training provided by~     a human being.~   "
201887|NCT00919893|"~     In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen~     extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was~     investigated. The purpose of this study is to determine whether Cernilton is safe and~     effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.~   "
201888|NCT00919880|"~     The purpose of this study is to determine whether neo-adjuvant weekly paclitaxel with~     carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer,~     and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency~     of neo-adjuvant chemotherapy.~   "
201889|NCT00919867|"~     Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE~     (lisdexamfetamine dimesylate) when given alone, and in combination.~   "
201890|NCT00919854|"~     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the~     medication), safety and antiviral activity to support dose recommendations by body weight of~     darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs~     (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.~   "
201891|NCT00919841|"~     Women who naturally deliver a singleton will be invited to participate the study. Weekly~     transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus~     is completely involuted. The pattern of involution will be analyzed.~   "
201892|NCT00919828|"~     This is a prospective, multi-center, non-randomized study to evaluate performance of an~     external monitor for heart failure patients~   "
201893|NCT00919815|"~     Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy~      Objective: A randomised double blind controlled trial comparing Ciclosporin and~     Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the~     treatment of new Type 1 Reactions as Prednisolone.~   "
201922|NCT00919412|"~     The goal of this study is to identify a non-invasive predictor or predictors that will~     increase the clinician's ability to identify patients with preterm labor (PTL) at risk for~     preterm delivery (PTD). Through these studies we also hope to reveal potential therapeutic~     targets in the prevention of prevention of preterm births.~      The study hypothesis is that we can identify non-invasive predictors of PTL at risk for PTD.~   "
204392|NCT00886301|"~     The aim of the study is to find new clinico-biological and medical imaging parameters~     associated with non alcoholic steatohepatitis in overweight and obese patients.~   "
201894|NCT00919802|"~     Anecdotal evidence suggests female patients with painful bladder disorder interstitial~     cystitis (IC) can experience a significant attenuation of their systems while breastfeeding.~     Since it has been shown that postpartum lactation is a time associated with decreased levels~     of stress, and stress has been shown to exacerbate IC-related pain, the investigators have~     developed an interest in the effects of the hormones involved in postpartum lactation on~     stress and pain. Based on a series of pre-clinical experiments, the investigators believe the~     hormone oxytoxin has both analgesic and anxiolytic properties which make it a potentially~     useful agent for the treatment of stress-exacerbated chronic pain syndrome such as IC.~     Therefore, the investigators propose a double-blinded, placebo-controlled crossover trial of~     intranasal oxytocin vs. intranasal saline for bladder pain in a cohort of patients with IC~     and some degree of continuous, daily pain.~   "
201895|NCT00919776|"~     Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum~     Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of~     patients whose ENL is not controlled with standard Prednisolone.~      Objective: A pilot double blind controlled study randomizing patients whose ENL is not~     controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a~     group treated with additional steroid only.~   "
201896|NCT00919763|"~     This is a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives:~     To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus~     its vehicle in adult subjects with at least moderate atopic dermatitis.~      Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over~     4 weeks versus its vehicle on 5% - 20% involved BSA (excluding Head/Neck) in adult subjects~     with at least moderate atopic dermatitis.~   "
201897|NCT00919750|"~     The purpose of this study is to collect and store brain tissue samples and blood from~     children with brain cancer that will be tested in the laboratory. Collecting and storing~     samples of tumor tissue and blood from patients to test in the laboratory may help the study~     of cancer in the future.~   "
201898|NCT00919737|"~     The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the~     treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.~   "
201899|NCT00919724|"~     The blood vessels that carry blood from the heart to the rest of the body are normally~     capable of relaxing and constricting when needed to provide more or less blood to the body.~     The inability of blood vessels to relax and widen may increase the risk of heart disease and~     stroke. One potential cause of this inability is inflammation. Because HIV infection is~     associated with inflammation, it is possible that the blood vessels in people infected with~     HIV may not relax properly. The purpose of this study is to determine whether people infected~     with HIV have worse blood vessel function than people without HIV infection.~   "
201900|NCT00919711|"~     A randomized, open label study to assess the safety and effectiveness of Denosumab,~     administered every 6 months and Actonel ® (Risedronate), administered monthly in post~     menopausal women transitioned from weekly or daily Alendronate therapy.~   "
201901|NCT00919698|"~     The overall purpose of this trial is to assess the relationship between a daily awakening~     from sedation and the prevalence of delirium, and in doing so better characterize delirium in~     the ICU.~   "
201902|NCT00919685|"~     Shock is a severe deficiency in oxygen at the cell level which could lead to the death.The~     study was aimed at finding markers of treatment response in patients with shock, with a~     better accuracy than that of lactate actually used : hypoxia-inducible factor (HIF),~     circulating DNA (cDNA), and plasma from cells (MPs).~   "
201903|NCT00919672|"~     Sacral nerve stimulation (SNS) has become a well-established treatment for patients with~     fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood~     but recent studies have shown that the motility of the whole colon is modulated during the~     stimulation. This modulation of the colonic motility could be a potential mechanism of an~     action to relieve the symptoms in patients with IBS.~      Twenty eight patients with IBS will be enrolled in the study. They have to meet the ROME III~     criteria, and also satisfy the criteria for implantation of a neurostimulator.~      After a post implantation period where the programming of the neurostimulator is optimised,~     the patient is randomized in a double blinded design to receive either ON-OFF or OFF-ON~     stimulation in a 2-month period.~      At the end of each period (ON/OFF) the patient will be examined with Magnet Tracking System~     (MTS) for motility and with impedance planimetry including thermal stimulation (circulating~     water)for multimodal sensory testing of the rectum.~      This is based on the study hypothesis that the motility of the small intestine and the colon~     is changed in IBS patients according to their subtype (Diarrhoea-IBS, Constipation-IBS and~     Disordered bowel habit-IBS) compared to healthy persons. And that SNS will affect the~     motility of the small intestine and the colon in IBS patients as well as SNS will affect the~     perception of pain/discomfort in the rectum in IBS patients.~      The effect of ON-OFF-sacral nerve stimulation on the IBS patients and thereby their IBS~     symptoms will also be evaluated by an IBS score (GSRS-IBS)and on quality of life by an IBS~     Impact Scale (IBS-IS) as well as the significance of placebo effect in the treatment of~     patients with IBS with SNS will be evaluated.~   "
201904|NCT00919659|"~     The purpose of this study is to determine whether the additional nutrition support is~     improving the nutritional status of patients suffering cancer caxechia or not.~   "
201905|NCT00919646|"~     This is a prospective, single center, non-randomized study to evaluate the arrhythmia~     monitoring performance of the AVIVO™ System in a hospital setting.~   "
201906|NCT00919633|"~     The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon~     alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a~     safe and effective treatment for patients with chronic hepatitis C infection as compared to~     patients who receive standard treatment.~   "
201923|NCT00919399|"~     This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal~     induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane~     (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors~     of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for~     exemestane and 20 mg / day for 4 months for tamoxifen.~   "
202238|NCT00915265|"~     The purpose of this study is to compare the continuous preperitoneal infusion of local~     anesthetic and continuous epidural analgesia for postoperative pain management in fast-track~     open colorectal surgery.~   "
201907|NCT00919620|"~     One of the commonly adopted strategies in improving outcome in psychotic disorders is by~     focused, specific and intensive intervention in the initial few years of the disorder.~     However the effects of intervention and the optimal duration of intervention have seldom been~     examined in randomized studies. This study uses a randomized controlled study design to~     investigate the effectiveness of stage-specific case-management in improving outcome of first~     episode psychotic disorders. It also addresses whether two years of case-management is less~     effective than four years of case-management over a four year period. A total of 500~     subjects, who aged 25 or above, and diagnosed with first episode psychotic disorders, will be~     and randomized into 3 groups: (1) standard care alone without case management, (2) two-year~     case management, (3) four-year case management. All groups will receive usual standard care~     treatment. This four-year follow-up study will assess symptoms, functioning, quality of life~     as well as health economics data.~   "
201908|NCT00919607|"~     The primary objective of the study is to evaluate the pharmacokinetics of XR quetiapine~     fumarate(300mg,600mg,and 800mg once-daily) in Chinese schizophrenic patients .~   "
201909|NCT00919594|"~     The current proposal is a randomized, controlled, clinical trial to evaluate the~     intergenerational impact of treating depressed mothers whose children suffer from psychiatric~     disorders.~   "
201910|NCT00919581|"~     The purpose of the study is to investigate inflammatory and other substances that may be~     elevated in the blood and blood cells following spinal cord injury (SCI). These substances~     will be evaluated in samples from people who have had a spinal cord injury due to trauma~     (e.g. car accident or a fall) within the first week (acute) or at least one year ago~     (chronic). Specifically, the study will evaluate the presence and levels of a protein,~     macrophage migration inhibitory factor (MIF). MIF is released by cells and has a specific~     effect on the way cells behave, communicate and work together. In several other medical~     conditions, MIF is known to increase inflammation in the body. By comparing blood samples~     from individuals with spinal cord injury and uninjured (no spinal cord injury) individuals,~     the investigators will try to find out if MIF levels are increased in people with SCI.~     Investigators will also use these samples to measure other proteins that increase~     inflammation in the body and to see if the biological activities of MIF can be reduced in a~     test tube by adding other substances to the blood samples. It is hoped that this study of MIF~     and other proteins related to inflammation will help improve the treatment of SCI in the~     future.~      We hope to enroll a total of 312 subjects in this study (50 with acute spinal cord injury,~     125 with chronic spinal cord injury, and 137 uninjured individuals).~   "
201911|NCT00919568|"~     Prospective, multicenter, non-randomized study to determine the performance of NUVANT Mobile~     Cardiac Telemetry system in arrhythmia detection.~   "
201912|NCT00919555|"~     The purpose of the study is to determine the safety and the efficacy of Tretinoin and~     Pioglitazone HCL in patients with ALS who are currently on Riluzole.~   "
201913|NCT00919542|"~     Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum~      Objective: A pilot (double blind controlled) study randomizing patients to treatment either~     with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of~     Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).~   "
201914|NCT00919516|"~     The purpose of this study is to evaluate the efficacy of dual intramuscular and~     intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of~     patients with moderate to severe peripheral arterial disease in whom amputation was~     considered the only viable treatment option.~      Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive~     intramuscular and intra-arterial stem cell injections will have improved ankle brachial index~     (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of major~     limb amputations.~   "
201915|NCT00919503|"~     This phase II clinical trial studies how well treosulfan and fludarabine phosphate with or~     without low dose radiation before donor stem cell transplantation works in treating patients~     with nonmalignant (noncancerous) diseases. Hematopoietic cell transplantation has been shown~     to be curative for many patients with nonmalignant (noncancerous) diseases such as primary~     immunodeficiency disorders, bone marrow failure syndromes, hemoglobinopathies, and inborn~     errors of metabolism (metabolic disorders). Powerful chemotherapy drugs and/or radiation are~     often used to condition the patient before infusion of the new healthy donor cells. The~     purpose of the conditioning therapy is to destroy the patient's abnormal bone marrow which~     doesn't work properly in order to make way for the new healthy donor cells which functions~     normally. Although effective in curing the patient's disease, many hematopoietic cell~     transplantation regimens use intensive chemotherapy and/or radiation which can be quite~     toxic, have significant side effects, and can potentially be life-threatening. Investigators~     are investigating whether a new conditioning regimen that uses less intensive drugs~     (treosulfan and fludarabine phosphate) with or without low dose radiation results in new~     blood-forming cells (engraftment) of the new donor cells without increased toxicities in~     patients with nonmalignant (noncancerous) diseases.~   "
201916|NCT00919490|"~     The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of~     blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male~     adult in Japan.~   "
201917|NCT00919477|"~     To gather information on the safety of monotherapy of Casodex® tablets 80 mg, targeting~     prostate cancer patients who have no history of having received treatment by either endocrine~     therapy (including surgical castration).~   "
201918|NCT00919464|"~     This study is to determine the natural history of compartment pressures in the anterior thigh~     secondary to a fracture of the femoral shaft.~   "
201919|NCT00919451|"~     Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy~      Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line~     drug in patients with Type 1 Reactions who have not responded to a 12 week course of~     Prednisolone.~   "
201920|NCT00919438|"~     This is a single center, non randomized study to gather data to correlate physiological~     signals with the patient's fluid status during fluid removal in hemodialysis.~   "
201936|NCT00919217|"~     The investigators' overall hypothesis is that appearance or worsening of relapsing-remitting~     multiple sclerosis (RR-MS) symptoms are affected by various factors including stress,~     hormonal cycles, illness and missed medications.~   "
201924|NCT00919386|"~     To examine a patient's quality of life using three methods for measuring stent size: (a)~     direct measurement, (b) patient height, and (c) a standardized formula. The intent of the~     study is to show if there is a difference in a patient's quality of life, postoperative~     symptoms, pain medication and anticholinergic use by using one of these specific methods for~     stent size determination. No method is interventional in this study.~   "
201925|NCT00919373|"~     The main objective of this study is to compare the time from randomization to the first~     recurrence of any ventricular tachycardia (VT) in patients undergoing VT ablation (for stable~     VTs) and substrate ablation (for unstable VTs) after an initial episode of stable VT and~     patients not undergoing ablation, with both groups under the protection of an ICD.~   "
201926|NCT00919360|"~     The purpose of this study is to figure out some of the differences in bodily function between~     women who have preeclampsia and those who do not.~        -  This may eventually lead to an understanding of its cause. At this time, there is no~          known way to prevent preeclampsia, and the cause is not known.~        -  The only treatment is delivery of the baby, even if it is premature, in order to~          decrease the risk to the mother.~   "
201927|NCT00919347|"~     The purpose of this study is to measure the prevalence and severity of cardiac autonomic~     neuropathy (CAN), diabetic autonomic neuropathy (DAN) which in non-diabetics is termed~     advanced nervous system (ANS) dysfunction, and autonomic dysfunction as well as the overall~     sympathovagal balance (SB) in the CEFH population of diabetic patients versus non-diabetic~     patients undergoing elective vitreoretinal surgery.~   "
201928|NCT00919334|"~     To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression~     in Hong Kong schoolchildren using simultaneous vision approach.~   "
201929|NCT00919321|"~     Patients with chronic lymphocytic leukemia (CLL)have had very poor humoral responses to~     pneumococcal polysaccharide vaccine (PPV). The vaccine in which pneumococcal polysaccharide~     antigens are conjugated to protein (PCV) have been immunogenic in CLL patients in our~     previous studies.~      The purpose of this study is to evaluate the duration of these vaccine-induced antibodies and~     the function of memory cells by giving a one dose of PPV-vaccine after several years of~     PCV-vaccination.~   "
201930|NCT00919308|"~     Hypothesis #1: Residents who complete a structured, ultrasound guided simulation training~     protocol will have superior skills at central venous catheter (CVC) insertion on actual~     patients as compared to residents who are trained in CVC insertion according to the~     traditional, bedside apprenticeship model as measured by a reduced failure rate at CVC~     insertion.~      Hypothesis #2: Residents who complete a structured, ultrasound guided simulation training~     protocol will have superior skills at CVC insertion on actual patients as compared to~     residents who are trained in CVC insertion according to the traditional, bedside~     apprenticeship model as measured by:~        1. a reduced number of attempts at venous cannulation,~        2. a decreased rate of technical errors and a decreased complication rate based on an~          independent rater's evaluation using a procedure checklist, and~        3. a decreased time to CVC insertion from opening the catheter kit to placement of sterile~          dressing as timed by an independent rater.~   "
201931|NCT00919295|"~     This study aims to investigate the anti-nociceptive biogenic amine (serotonin~     [5-hydroxytryptamine; 5-HT], norepinephrine [NE], dopamine [DA], and their metabolites)~     status, and serum levels of cytokines, BDNF and BH4 in Thai fibromyalgia syndrome (FMS)~     patients compared with a representative Thai population. The efficacy and the tolerability of~     mirtazapine as monotherapy for FMS will also be assessed. In addition, proof of concept of~     the indoleamine 2,3-dioxygenase (IDO) activity in FMS will be conducted.~      The study will be divided into three parts. In part I, FMS patients of Thai ethnicity will be~     examined to determine the blood and/or urinary level of anti-nociceptive biogenic amines,~     cytokines, BDNF and BH4 by comparison with the demographically matched, but unrelated,~     healthy normal controls (HNC). In part II, the FMS subjects from part I study will be~     randomized to blinded therapy with mirtazapine or identical appearing placebo. There will be~     three treatment groups (N=1:1:1) to accommodate two dosages of mirtazapine (15 mg, 30mg) and~     placebo given before bedtime. Pill counts at baseline and at follow-up visits will document~     compliance. Standard outcome instruments (translated and validated in Thai language) will be~     used at baseline and at each of the follow-up visits. The co-primary outcome variable will be~     the changes in the pain visual analog scale (PVAS) score and pain responders (>= 30% PVAS~     reduction). Secondary clinical outcome variables of interest will include depression,~     insomnia, anxiety, physical function, morning stiffness, patient global assessment of disease~     status, patient global impression of change, fibromyalgia impact questionnaire (FIQ, quality~     of life and adverse experience. The changes of biogenic amine and IGF-1 concentrations in~     blood and/or urine with the treatment will be examined as the secondary biochemical measures.~     In part III, the IDO activity of depressed FMS, non-depressed FMS and HNC will be compared.~     Moreover, the effect of mirtazapine treatment on the IDO activity in depressed and~     non-depressed FMS patients will be assessed.~      Study hypothesis~        1. Anti-nociceptive biogenic amine levels in Thai FMS patients are lower than in Thai~          healthy normal control.~        2. Higher IDO activity could be observed in FMS patients.~        3. Higher cytokines could be observed in FMS patients.~        4. Higher BDNF could be observed in FMS patients.~        5. Lower BH4 could be observed in FMS patients.~        6. Mirtazapine is effective in FMS treatment.~   "
201932|NCT00919282|"~     The purpose of this study is to examine the efficacy and safety of the drug combination GFF~     in patients with advanced pancreatic cancer (APC).~   "
201933|NCT00919269|"~     The purpose of this study is to collect and store tumor tissue, blood, and bone marrow~     samples from patients with soft tissue sarcoma that will be tested in the laboratory.~     Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test~     in the laboratory may help the study of cancer.~   "
201934|NCT00919243|"~     Hyperuricemia is a very common finding in patients with heart failure. It is usually related~     to diuretic use and deteriorated renal function. The recently evidence showed that uric acid~     (UA) lowering therapy may improve clinical status in symptomatic heart failure patients with~     hyperuricemia. In their clinical practice, the investigators found that glucocorticoids could~     dramatically lower UA while improving renal function. Thus the investigators design this~     randomized head to head study to test our hypothesis that prednisone have the same efficacy~     to allopurinol on lowering UA and could improve renal function at the same time.~   "
201935|NCT00919230|"~     At present our current practice is to provide a course of oral iron therapy for those~     patients with a post-operative haemoglobin which is below normal, but not severe enough to~     require a blood transfusion. Such a practice is not without side effects from the iron~     tablets, namely ingestion, nausea, diarrhoea, constipation. There is little evidence in the~     literature to support the current practice of using iron, with only one small randomised~     trial suggesting such therapy is unnecessary. We propose to recruit 300 patients recovering~     from a hip fracture with a post-operative haemoglobin below 11g/l. For those patients willing~     to enter the study, half will be given oral iron therapy (ferrous sulphate 200mg twice daily)~     for one month. The haemoglobin will be checked when the patients attends the hip fracture~     clinic at 6 weeks after discharge.~   "
201937|NCT00919204|"~     As part of the global clinical development program for AG-013736, studies are ongoing (and~     planned) in cancer patients in China. An assessment of AG-013736 pharmacokinetics in Chinese~     subjects, as required by the Chinese Health Authorities, is therefore warranted.~      In the current study the single dose pharmacokinetics of AG-013736 will be characterized at 3~     doses (5 mg, 7 mg and 10 mg).~   "
201938|NCT00919191|"~     A study to compare the skin irritation potential of two marketed gels for acne treatment,~     each applied to half of the face of healthy volunteers.~   "
201939|NCT00919178|"~     Infection with dengue viruses is one of the leading causes of hospitalization and death in~     children in several tropical Asian counties. The World Health Organization (WHO) estimates~     that these viruses are responsible for more than 50 million cases of dengue fever (DF) and~     approximately 0.5 million cases of the more severe disease, dengue hemorrhagic fever/ shock~     syndrome (DHF/DSS) annually. Because dengue viruses are endemic in most tropical and~     subtropical regions, keeping more than 2 billion persons at risk for acquiring dengue, the~     WHO has made development of a dengue vaccine a top priority.~      The purpose of this study is to evaluate the safety and effectiveness of a candidate DEN4~     vaccine aimed at preventing infection with dengue virus serotype 4.~   "
201940|NCT00919165|"~     To determine the effect of carotid artery stenting, on cognitive function, in patients with~     high grade carotid artery stenosis~   "
201941|NCT00919152|"~     This study will be a retrospective electronic medical chart review of all patients admitted~     to adult intensive care medicine units (ICU) at The Nebraska Medical Center over a three-year~     period from January 2006 through December 2008. The study will have three primary aims:~        -  Aim 1: Determine correlates (qualifying criteria) of patients initiated on enteral~          versus parenteral PPIs as first choice in ICU and after discharge from ICU,~        -  Aim 2: Based on correlates determine number of patients receiving parenteral PPIs that~          could receive enteral therapy as first choice in ICU and after discharge from ICU,~        -  Aim 3: Estimate the potential savings in drug costs associated with conversion of~          eligible patients from parenteral to enteral PPI therapy with emphasis on lansoprazole~          solutab in the ICU and conversion of eligible patients requiring continued AST from~          parenteral to enteral PPI therapy after discharge from ICU.~   "
201942|NCT00919139|"~     RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer~     to study in the laboratory may help doctors find better ways to ways to treat the cancer.~      PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from~     patients with multiple myeloma, smoldering myeloma, Waldenstrom's macroglobulinemia,~     amyloidosis, and monoclonal gammopathy of undetermined significance to be tested in the~     laboratory.~   "
201943|NCT00919126|"~     The purpose of this study is to evaluate the quantity of propofol administered with Xenon in~     two inspiratory concentrations, to maintain comparable depth of anaesthesia during the~     maintenance period of general anaesthesia.~   "
201944|NCT00919113|"~     A new device for interstitial cystitis is compared to inactive control to determine if it is~     safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.~   "
201945|NCT00919100|"~     A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of~     cannulation when compared to vapocoolant spray.~   "
201946|NCT00919087|"~     This is a prospective, single center, non-randomized study to evaluate the arrhythmia~     detection performance during ventricular events.~   "
201947|NCT00919074|"~     This research project will compare the use of the double wire technique with the placement of~     a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut~     papillotomy. Currently, the data supporting either of these approaches is limited to the~     referenced case series. More data on the success and complication rates of these techniques~     are needed. The investigators believe either of these approaches would be preferred by less~     experienced endoscopists to precut papillotomy. Consequently, it is important to~     differentiate these techniques and identify which patients may benefit from one or both.~   "
201948|NCT00919061|"~     The purpose of this study is to test an investigational combination of drugs for bile duct or~     gallbladder cancers.~      Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat~     bile duct and gallbladder cancers. We are looking to improve treatment results. We will~     attempt to do so by adding sorafenib (a type of monoclonal antibody) to your treatment plan.~     Sorafenib acts by attaching to blocking specific targets on cells. These targets may help the~     cancer cells grow and divide. This study will help answer the question of whether sorafenib~     is a helpful drug in patients with bile duct or gallbladder cancers when given with~     gemcitabine and cisplatin.~      This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects,~     good and/or bad, sorafenib in combination with gemcitabine and cisplatin has on advanced bile~     duct and gallbladder cancers.~   "
201949|NCT00919048|"~     To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an~     incontinence work-up in an urogynecology practice to healthy female volunteers.~   "
201950|NCT00919035|"~     This is a single institution, open label, phase II study in androgen-independent prostate~     cancer patients who are chemotherapy-naïve. Patients will receive Torisel® 25 mg weekly.~     Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or~     the investigator's discretion.~   "
201951|NCT00919022|"~     Cyproterone acetate (CPA) is a steroidal antiandrogen which has affinity with progesterone~     and with glucocorticoid receptors. Cyproterone acetate is long-term proven effective~     treatment of inoperable carcinoma of the prostate.~      Sexual functions remain very important in men with prostate cancer. However sexual functions~     are deteriorating fast with course of the disease. The influence of CPA on sexual functions~     remains controversial. IIEF-5 erectile dysfunction questionnaire is currently widely used~     validated simple scoring system for diagnosing of erectile dysfunction and belongs to most~     used systems in Czech Republic. At present there are no data on CPA influence on IIEF-5~     scored erectile dysfunction within the use of its indication in prostate cancer.~   "
201982|NCT00918619|"~     This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A~     total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical~     centres. The primary objective of this study is to show that the collagen based haemostatic~     device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving~     haemostasis after hepatic resection.~   "
201952|NCT00919009|"~     Most HCC patients are diagnosed at advanced stages in Korea, transcatheter arterial~     chemoembolization is considered a key modality for palliative treatment in these HCC~     patients. TACE is currently one of the mainstays of palliative treatments worldwide for~     patients with inoperable HCC and it has shown survival benefits in patients with unresectable~     HCC. TACE consists primarily of directly targeted chemotherapy and embolization of arteries~     feeding the tumors, inevitably resulting in a hypoxic insult to HCC and surrounding liver~     tissues. Ischemic injury after TACE has been found to induce the upregulation of circulating~     vascular endothelial growth factor (VEGF), which is essential for tumor growth, invasion and~     metastasis in patients with HCC. Recent studies have shown a significant correlation between~     pre-TACE level of circulating VEGF or VEGF upregulation after TACE and HCC characteristics,~     including tumor size, vascular invasion, and metastasis. TACE consists primarily of directly~     targeted chemotherapy and embolization of arteries feeding the tumors, inevitably resulting~     in a hypoxic insult to HCC and surrounding liver tissues. Central tumor hypoxia was found to~     upregulate proangiogenic growth factors, which are potent mediators of tumor angiogenesis.~     Therefore, expression of circulating or tissue VEGF was enhanced after TACE in patients or~     animals with HCC, and there could be some probability of adverse effects of TACE in HCC~     patients.~      In addition, the investigators demonstrated that a transient increment of serum VEGF level~     after TACE was significantly correlated with poor outcomes of tumor progression, especially~     outcomes relevant to distant metastasis.~      Therefore, these findings suggest a rationale for applying adjuvant therapy with~     anti-angiogenesis agent additional treatment of anti-angiogenesis after TACE or during TACE~     in a selected group of patients HCC.~      The aim of this study is to evaluate efficacy and safety of sorafenib 400 mg bid with TACE in~     patients with unresectable and/or inoperable HCC.~   "
201953|NCT00918996|"~     Cesarean section is now the most common major surgical procedure performed on women world~     wide. In the United States, approximately 1 in 4 deliveries is by this method. With the~     increasing numbers of cesarean sections, there is the need to utilized evidence based~     techniques to optimize outcomes and minimize complications.Creation of the bladder flap is an~     integral step of the standard cesarean section. The bladder flap is made by superficially~     incising and dissecting the peritoneal lining to separate the urinary bladder from the lower~     uterine segment. Started in the pre-antibiotic era, the rationale for the bladder flap was to~     enable the surgeon gain access to the lower uterine segment while minimizing injury to the~     bladder. Its subsequent closure was supposed to protect the peritoneal cavity from~     intrauterine infection. Since then, closure of the bladder flap has been demonstrated to be~     unnecessary and has been abandoned. The bladder flap however, continues to be performed~     without evidence of benefit.~      Evidence on the role of the bladder flap in cesarean section is very limited. In emergent~     cesarean sections where rapid delivery is the goal, the bladder flap is commonly omitted. A~     simplified method of cesarean section (Pelosi-type) including omission of the bladder among~     other modifications has been shown to be safe and cost saving. The single randomized trial on~     omission of the bladder flap as the only modification suggests short term benefits including~     shorter operating times, reduced blood loss and decreased postoperative analgesic~     requirements. This study has been criticized for evaluating only short term outcomes and~     including only primary cesarean sections. The paucity of evidence for or against this~     commonly utilized technique in cesarean section is the rationale for this study.~      The goal of this study is to employ a well designed randomized controlled clinical trial to~     evaluate the effects of omitting the bladder flap creation at cesarean section. We~     hypothesize that omission of the bladder flap in both primary and repeat cesarean sections~     will be associated with shorter operating time without a significant increase in~     intraoperative and postoperative complications.~   "
201954|NCT00918983|"~     This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the~     treatment of BPH (benign prostatic hyperplasia) as compared to placebo.~   "
201955|NCT00918970|"~     Context: A major lack of organ donors is a serious public health problem. It determines a~     prolonged delay before a transplant can be performed and thus a significant number of deaths~     of patients waiting for transplantation. The aim of this project is to reduce the delay of~     the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.~      The diagnosis of brain death is strictly defined by the law and relies either on two~     consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack~     of cerebral circulation during a brain angiography performed after suspecting brain death on~     the clinical exam. However, in usual practice, it is difficult to have all the needed~     clinical arguments, and their interpretation can be difficult in the pathological context.~     This may participate in the delay and the lack of patients potentially donors.~      Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous~     ECG recording. The investigators could find that a decrease in autonomic nervous system~     activity, as measured through the ECG, was correlated to the transition to brain death~     assessed by cerebral angiography. The loss of cardiac variability was always observed between~     two cerebral angiographies, one before and the second after brain death. This study allowed~     the investigators to calculate the threshold values of sympathetic and parasympathetic~     activities to confirm brain death.~   "
201956|NCT00918957|"~     This study is designed to show how well tobramycin inhalation powder works and how safe it is~     when produced by a modified manufacturing process~   "
201957|NCT00918944|"~     To determine whether an innovative clinical decision support system embedded in an existing~     electronic health record (EHR) will improve provider adherence to the existing National~     Asthma Education and Prevention Program (NAEPP) guidelines.~      12 primary care pediatric practices at The Children's Hospital of Philadelphia(both urban and~     suburban sites) will be randomized to receive either a passive EHR (control sites) or an~     interactive decision support system (intervention sites).~   "
201958|NCT00918931|"~     The goal of this clinical research study is to learn if obatoclax mesylate can help to~     control systemic mastocytosis. The safety of this drug will also be tested.~   "
201959|NCT00918918|"~     Rationale: High-density lipoprotein (HDL), which is consistently increased after moderate~     alcohol consumption, is an abundant plasma lipoprotein that is generally thought to be~     anti-inflammatory in both health and infectious disease. HDL binds and neutralizes the~     bioactivity of potent bacterial remnants such as lipopolysaccharides (LPS) which stimulate~     the host innate immune responses.~      Primary objective: To explore whether prolonged moderate alcohol consumption affects in vivo~     cytokine response after a low dose of LPS in young, normal-weight men.~   "
201960|NCT00918905|"~     Patients with COPD are often admitted to the hospital with an exacerbation. It is the most~     common cause for admissions to medical wards. The patients are often readmitted. This is har~     great impact on health economy and is a significant factor to medical beds.~      The aim of this study was to investigate the effect of telemedicine consultations between~     respiratory nurses at the hospital and COPD patients in their homes after a discharge from~     the hospital, which was caused by an exacerbation.~   "
201961|NCT00918892|"~     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer~     may help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at tumor tissue samples from patients who have~     undergone surgery for breast cancer.~   "
201962|NCT00918879|"~     Saxagliptin is a new investigational medication being developed for treatment of type 2~     diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients~     with inadequate glycaemic control with diet and exercise.~   "
201963|NCT00918866|"~     The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse~     effects during Right Heart Catheterization. This research was requested by the FDA.~   "
201964|NCT00918853|"~     This multicentric prospective study evaluates the role of the margins resection and the~     ganglionic status when using a quality standard for the resection of adenocarcinoma of the~     head of the pancreas.~   "
201965|NCT00918840|"~     PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether~     therapeutic immunization during highly active antiretroviral therapy (HAART) induces~     elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in~     HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load~     set point following analytical treatment interruption (ATI). Subjects will be randomized to~     receive either DermaVir Patch (8 subjects per cohort) or DermaVir Patch Placebo (8 subjects~     per cohort) every four weeks for three applications while receiving maximally suppressive~     HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks.~   "
201966|NCT00918827|"~     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who~     have undergone surgery and chemotherapy may help doctors predict how well patients will~     respond to treatment.~      PURPOSE: This research study is looking at tumor samples from patients with stage III colon~     cancer who have undergone surgery and chemotherapy.~   "
201967|NCT00918814|"~     Dose Ranging and Dose Frequency of LIPO-102~   "
201968|NCT00918801|"~     This study is an expansion of a previous study done to determine how thinking skills relate~     to hypoglycemia (low blood sugar) and certain regions of the brain in children and~     adolescents. In this study, the investigators are testing thinking skills and measuring brain~     activity in adolescents with and without type 1 diabetes mellitus.~   "
201969|NCT00918788|"~     RATIONALE: Collecting and storing samples of breast tissue from patients who have undergone~     biopsy or surgery to test in the laboratory may help the study of cancer in the future.~      PURPOSE: This laboratory study is looking at samples of breast tissue from women who have~     undergone breast biopsy or surgery.~   "
201970|NCT00918775|"~     The goal of this clinical research study is to learn if the surgical removal of your primary~     tumor or the parts of the cancer that has spread to other parts of the body is a good method~     for treating patients who have kidney cancer. Only the parts of the cancer that has spread~     will be removed during the surgery.~   "
201971|NCT00918762|"~     RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or~     malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not~     yet known whether transoral robotic surgery is more effective than standard surgery in~     diagnosing and treating larynx and pharynx tumors.~      PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared~     with standard surgery in treating patients with benign or malignant tumors of the larynx or~     pharynx.~   "
201972|NCT00918749|"~     Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study~     in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also~     participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized~     to 1 of 3 treatment regimens for 3 months.~   "
201973|NCT00918736|"~     The aim of this study was to investigate the efficacy and safety of three weekly~     intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle~     Osteoarthritis (OA).~   "
201974|NCT00918723|"~     This phase I/II trial studies the side effects and best dose of vorinostat when given~     together with fludarabine phosphate, cyclophosphamide, and rituximab and to see how well they~     work in treating patients with previously untreated B-cell chronic lymphocytic leukemia (CLL)~     or small lymphocytic lymphoma (SLL). Vorinostat may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as rituximab, may block cancer growth in different ways by targeting certain~     cells. Giving vorinostat together with fludarabine phosphate, cyclophosphamide, and rituximab~     may be a better treatment for CLL or SLL.~   "
201975|NCT00918710|"~     High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell~     carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might~     be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and~     overall survival (OS) as compared to HPV negative OP-SCC ; hypothesis : 2y DFS > 20%~     improvement). The principal objective is to determine the impact of the status of HR-HPV in~     the prognosis of the OP-SCC. The principal criteria is the 2-years DFS.~      Secondary objective : virologic characteristics of HPV+ tumors.~   "
201976|NCT00918697|"~     In this prospective randomized clinical trial, confocal microscopy was used to evaluate the~     effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive~     keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical~     equivalent less than -4.00 D who completed all follow-up visits were evaluated.~   "
201977|NCT00918684|"~     The purpose of this study is to look at the relationship between age related structural brain~     changes and changes in depressive symptoms,disability and several aspects of cognitive~     functioning following treatment with escitalopram.~   "
201978|NCT00918671|"~     From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse~     headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate~     the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and~     with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized~     patients still alive 4 years after primary inclusion time will be invited to a follow up~     interview, evaluating the headache complaints and the proportion of recurrent medication~     overuse.~   "
201979|NCT00918658|"~     RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer~     to study in the laboratory may help doctors find better ways to treat the cancer.~      PURPOSE: This research study is looking at natural killer cells in bone marrow and blood~     samples from patients with hematologic cancer and from patients who do not have cancer.~   "
201980|NCT00918645|"~     RATIONALE: Diagnostic procedures, such as radionuclide imaging using calcium-41 (41Ca)~     chloride aqueous solution, may help predict progressive disease in patients with prostate~     cancer and bone metastasis.~      PURPOSE: This clinical trial is studying how well calcium-41 (41Ca) chloride aqueous solution~     works in diagnosing patients with prostate cancer and bone metastasis.~   "
201981|NCT00918632|"~     The study is designed to evaluate the effect of food on typical blood levels obtained after~     oral dosing of AG-013736. Drug levels in blood will be compared after an overnight fast and a~     high-fat, high-calorie meal.~   "
201984|NCT00918593|"~     By applying short electric pulses to cells, the cell membranes can become permeabilised~     (electroporation). This can be used augment the effect of chemotherapy, by providing direct~     access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several~     hundred fold, enabling once-only treatment. The investigators wish compare~     electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm~     in diameter from any kind of histology.~   "
201985|NCT00918580|"~     This study is to evaluate the safety, tolerability and immunogenicity of 13-valent~     pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been~     vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of~     antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease~     after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18~     years of age. They will be given the vaccination twice, each vaccination separated by~     approximately 6 months.~   "
201986|NCT00918567|"~     Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there~     is only one published study specifically designed to evaluate its efficacy in school~     settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3~     mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However,~     children are typically referred for treatment because of real life problems in functioning,~     not symptoms (Pelham, Fabiano, & Massetti, 2005). While ATX has been found to produce~     functional improvements at home, the Weiss study found limited results in this area at~     school.~      Furthermore, almost no research has examined the effects of combining ATX and behavior~     therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of~     hyperactivity/impulsivity and increased the number of subjects reaching optimal response~     (Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve~     functional performance in the classroom. The effects of combined therapy may be even larger~     for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.~      Objective: The primary objective was to evaluate the effects of ATX alone and in combination~     with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed~     using traditional symptoms measures as well as functional measures of academic and behavioral~     improvements in the classroom.~   "
201987|NCT00918554|"~     The purpose of this study is to determine whether methotrexate is a effective corticosteroid~     sparing agent in the treatment of sarcoid-associated uveitis.~   "
201988|NCT00918541|"~     20 patients will be recruited. The aim of the study is to determine the natural progression~     of atherosclerotic disease.~   "
201989|NCT00918528|"~     The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time~     of internal urethrotomy in order to prevent the recurrence of urethral strictures.~   "
201990|NCT00918515|"~     This is a Phase I, single centre, open label study to assess the safety, tolerability,~     pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending~     doses in healthy male volunteers.~   "
201991|NCT00918502|"~     The primary objective of the study is to gather data to correlate physiological signals~     measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory~     status, including apnea and hypopnea events, during polysomnography~   "
201992|NCT00918489|"~     Primary objective of the study is to investigate the efficacy of vorinostat in patients~     suffering from selected histological types of soft tissue sarcoma. Further evaluations relate~     to the safety and tolerability of vorinostat, its pharmacokinetics (course of plasma~     concentration over time) and pharmacodynamics (mode of action). Only subjects with advanced,~     metastatic disease will be included in this trail.~   "
201993|NCT00918476|"~     The purpose of this study is to estimate the effect of filibuvir on the pharmacokinetics of~     ethinyloestradiol [EE] and levonorgestrel [LN], to assess the safety and tolerability of 600~     mg BID of filibuvir in healthy women and to investigate the pharmacokinetics of 600 mg BID of~     filibuvir in healthy women.~   "
201994|NCT00918463|"~     This is a Phase II, single institution, single-arm, open-label study of oral dasatinib~     monotherapy administered to subjects with relapsed or refractory aggressive DLBCL.~      This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.~      Research Hypothesis: Dasatinib, when administered orally at a continuous dose of 100 mg once~     daily, will be safe and effective in treating subjects that have failed prior therapies to~     diffuse large B cell lymphoma (DLBCL) or have relapsed disease.~   "
201995|NCT00918450|"~     This is a Phase 2b, open-label, multicenter, global study assessing the safety and efficacy~     of ABT-263 in subjects with B-cell CLL who have failed at least one prior~     fludarabine-containing regimen.~   "
201996|NCT00918437|"~     The aim of this study is to determine the postoperative course including effects on the~     quality of life following soft palate surgery with radiofrequency knife (RAUP).~   "
201997|NCT00918424|"~     Follow-on study to continue evaluation of the safety of OXC XR as adjunctive therapy in~     pediatric epilepsy~   "
201998|NCT00918411|"~     The purpose of this study is to explore and examine endpoints that allow evaluation of the~     clinically significant improvements, focusing on the patient's chief complaint and the~     severity of major IBS symptoms by this drug in patients with diarrhea-predominant irritable~     bowel syndrome (IBS).~   "
201999|NCT00918398|"~     The primary objective is to investigate the pharmacokinetics of AZD1981 given in different~     formulations and to measure renal clearance~   "
202000|NCT00918385|"~     This is a phase II multi-center study to determine the clinical impact of using a~     patient-specific genomic expression signature of androgen receptor (AR) activity to determine~     therapy for patients with castration-resistant metastatic prostate cancer (CRPC). After~     patient eligibility is determined, the genomic signature will be applied to fresh frozen~     tissue harvested from a metastatic lesion during image-guided biopsy. After assessing for~     androgen receptor activity, the investigators will select patients for either continued~     androgen manipulation with nilutamide (high AR activity) or targeted therapy with dasatinib~     (low AR activity). Once patients develop a first progression on either arm, patients will~     receive combination therapy with dasatinib and nilutamide. The primary aim is to estimate the~     median progression free survival in men with CRPC treated according to tumor AR activity. The~     investigators hypothesize that by treating men based upon AR activity, median progression~     free survival (PFS) will improve from a historical median of 3.0 months to 6.0 months.~   "
202001|NCT00918372|"~     The aim of this study is to determine the effects of extreme fitness in women. The incidence~     of coronary artery disease observed via multislice computed tomography (MSCT) angiogram will~     be compared with age and risk-matched controls from both sedentary and fitness activity~     groups who have never been significant runners. Life style, training volume and risk factors~     will be assessed.~   "
202002|NCT00918359|"~     Heat Intolerance (HI) is a life threatening deficiency that can lead to heat exhaustion, heat~     stroke (and possibly death) in a large number of military and civilian occupational groups.~     We have demonstrated malfunction of transcriptional pathways in the heat stressed HI~     phenotype and an altered gene expression profile compared to Heat Tolerant (HT) individuals.~     Such differences are evident even under normothermic basal/comfort conditions. Heat and~     exercise challenges during the heat tolerance test (HTT) further emphasize the differences~     between the groups, particularly during recovery at comfort temperatures. Our results~     indicate that it may be possible to identify markers of heat intolerance. To achieve this~     goal, we plan to design a cellular (lymphocyte) HTT experimental model and detect gene~     expression profiles using customized DNA microarrays and bioinformatic tools (the genes~     selected will be based on our previous DNA microarray studies). Lymphocyte samples collected~     from HT and HI individuals under resting/comfort conditions will be examined. Treatments and~     analyses are designed to reveal HI-associated gene-expression profiles (constitutive or~     inducible), and thereby find lymphocyte markers to identify individuals predisposed to heat~     injury. The identification of such subjects could prevent unnecessary loss of life. Notably,~     the rapidly changing climate in our era increases the number of occupation/age groups in~     which manifestations of HI will appear.~   "
202003|NCT00918346|"~     The objective of this study is to investigate the pharmacodynamics (as expressed in~     intraocular pressure [IOP]) of two formulations of tafluprost 0.0015% eyedrops (preserved and~     unpreserved) in patients with open-angle glaucoma or ocular hypertension.~      The primary aim of this study is to show that IOP reduction between the two formulations is~     equivalent at the end of the 4 week treatment period.~   "
202004|NCT00918333|"~     This phase I/II trial studies the side effects and best dose of panobinostat and everolimus~     when given together and to see how well they work in treating patients with multiple myeloma,~     non-Hodgkin lymphoma, or Hodgkin lymphoma that has come back. Panobinostat and everolimus may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
202005|NCT00918320|"~     The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and~     Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other~     paediatric solid tumors.~   "
202006|NCT00918307|"~     Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining~     malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular~     diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco~     smoking cessation has well known benefits on mortality and morbidity in the general~     population where tobacco cessation assistance programs are increasingly implemented. However,~     smoking cessation interventions have never been evaluated among HIV-infected patients. This~     trial aims at evaluating the efficacy and safety of varenicline for smoking cessation~     compared with placebo.~   "
202007|NCT00918294|"~     QuickOptTM optimization method provides a quicker, simpler and reliable alternative to~     standard echocardiography methods for optimization of sensed AV, paced AV and V-V delays in~     patients with CRT-P devices~   "
202008|NCT00918281|"~     Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection.~     Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8~     days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels~     of 18F uptake on PET.~   "
202009|NCT00918268|"~     Annual trial for registration influenza vaccine with the strain composition for season~     2009/2010.~   "
202010|NCT00918255|"~     This study will investigate how well adalimumab works in people with hidradenitis suppurativa~     (HS) in the short and long term.~   "
202011|NCT00918242|"~     The aim of this prospective study is to investigate the prevalence of coronary artery disease~     using computed tomography with family history of premature coronary heart disease~   "
202012|NCT00918229|"~     Primary Goal~      The study's primary goal is to assess the safety of the BioProtect biodegradable balloon~     implant and implantation procedure, in prostate cancer subjects undergoing routine radiation~     therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting~     adverse events.~      Secondary Goal~      The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable~     balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness~     will be assessed in terms of increased distance between anterior rectal wall and prostate and~     noticeable reduction of isodose to the rectum.~   "
202013|NCT00918216|"~     RATIONALE: Diagnostic procedures, such as laser spectroscopy, may help find and diagnose~     breast cancer.~      PURPOSE: This phase I trial is studying laser spectroscopy to see how well it works in~     diagnosing breast cancer in women with breast lesions.~   "
202014|NCT00918203|"~     The purpose of this study is to determine if participants with untreated locally advanced or~     metastatic non-small cell lung cancer have a better outcome when treated with olaratumab in~     combination with paclitaxel/carboplatin then when treated with paclitaxel/carboplatin alone.~   "
202015|NCT00918190|"~     The purpose of this trial is to study the effects of different combinations of antiemetics on~     the incidence of late onset postoperative nausea and vomiting.~   "
202016|NCT00918177|"~     The purpose of this study is to evaluate blood level profiles of multiple oral doses of~     AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.~   "
202017|NCT00918164|"~     The purpose of this study is to estimate the bioavailability of PF-04457845 tablets relative~     to solution and evaluate the effect of food (fasted vs. high fat meal) on the~     pharmacokinetics of an oral tablet formulation of PF-04457845~   "
202018|NCT00918151|"~     This study is conducted in Asia. The aim of this observational study is to evaluate current~     status of diabetes management, control, and complications in diabetic subjects in Asia.~   "
202019|NCT00918138|"~     The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on~     24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with~     T2DM inadequately controlled on metformin alone.~   "
202020|NCT00918125|"~     The investigators will examine whether an educational video increases patient knowledge about~     heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with~     information provided as compared to usual care. Additionally, the investigators will look at~     whether racial concordance (physician and patient being of the same race) improves~     satisfaction with the patient's treatment decision and disease knowledge. Our hypothesis is~     that a video in which participants are of the same race as the patient will provide better~     education and more satisfaction with the treatment decision and may lead to more patients~     choosing ICD therapy.~   "
202021|NCT00918112|"~     The purpose of this study is to develop a task to measure executive thinking skills that can~     be performed in a laboratory setting, but has clear parallels to the thinking demands of real~     life situations, and can be administered to patients such as those with Parkinson's who have~     difficulty moving.~   "
202022|NCT00918099|"~     Summary:~      Vaginal prolapse is a well-known disease and is observed in approximately 11% of all~     postmenopausal women and tending to increase with age. Consequently, many surgical procedures~     have been developed in order to ensure sufficient support for the bladder, rectum or vaginal~     vault depending on the site of the defect. However, many procedures are associated with a~     high recurrence rate up to 40 % even within one to two years after the surgical procedure.~      Due to the high recurrence rate new methods include the use of mesh, either biologically or~     synthetic. The latter is a permanent implant and therefore theoretically may result in a~     long-lasting anatomically correct position of the prolapse.~      Although the recurrence rate may be lower using a mesh such surgical procedures may be~     associated with adverse events such as erosions of the vaginal mucosa. Others have observed~     shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used.~     In contrast the recurrence rate is lowered up to 25%.~      The above-mentioned advantage of synthetic mesh is however, mostly based on few~     non-randomised studies. The investigators therefore find it of importance to evaluate whether~     a surgical procedure using a mesh implant is superior to conventional surgical techniques.~     The present study is a clinical controlled study where patients with anterior vaginal~     prolapse are randomised to either a mesh technique or a standard anterior procedure.~      The present study includes only two more visits at the outpatient clinic after the surgical~     procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and~     faecal leakage and sexual habits.~      Any participation in the study is totally voluntary and the patient may at any time withdraw~     herself. In any case the patient will receive the investigators' standard treatment.~   "
202023|NCT00918086|"~     Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially~     the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such as~     calcium and phosphate. There is new information that links vitamin D to the functioning of~     our immune system. The purpose of the study is to find out how vitamin D affects the immune~     system of patients with TB. We want to find out if correcting low vitamin D levels, in~     addition to getting standard therapy for TB, will help the immune system fight off TB~     infection more effectively.~      The study will be done at the Georgia National Center for Tuberculosis and Lung Diseases~     (NCTBLD) in Tbilisi, Republic of Georgia. 220 patients with tuberculosis and 80 family~     members or household contacts of patients with tuberculosis will be participating in this~     study. TB patients, already receiving standard TB therapy, will be randomly assigned to~     either receive the Vitamin D pill or a placebo for a total of sixteen weeks. Neither the~     subject nor the investigator will know whether the subject has received the Vitamin D or the~     inactive placebo.The subject will orally consume the Vitamin D/placebo tablet 3 times a week~     for the 1st 8 weeks (while in hospital) and then once every other week for the last 8 weeks(~     during out-patient visits to the hospital).~      The main study hypothesis is that Vitamin D supplementation helps patients with tuberculosis,~     who are on standard anti TB antibiotic therapy, get better faster.~   "
202024|NCT00918073|"~     We will conduct a sub-study of An Innovative Telephone Intervention for HIV+ Smokers,~     (NCT00502827) conducted by Drs. Gritz, Vidrine, and others. This is a randomized, prospective~     trial that will evaluate a cellular phone delivered counseling intervention versus standard~     of care for smoking cessation. In our sub-study, we will evaluate rates of progression in~     atherosclerosis in HIV/AIDS patients who quit smoking versus those who continue smoking by~     measuring carotid intima-media thickness(CIMT) and biomarkers of atherosclerosis at time~     point baseline, 1 year, and 3 year. The biomarkers measured include high-sensitivity~     Creactive protein, homocysteine, and IL-6. We will also evaluate rates of progression of CIMT~     in those who quit smoking versus those who continue smoking, based on race, sex, state of HIV~     disease, comorbid diseases, and lipid profile.~   "
202025|NCT00918060|"~     The purpose of this study is to evaluate clinical result including plaque index, gingival~     inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after~     used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in~     periodontal therapy~   "
202026|NCT00918047|"~     Study to evaluate the pharmacokinetics, safety, and tolerability of OXC XR as adjunctive~     therapy in pediatric subjects with refractory partial epilepsy.~   "
202027|NCT00918034|"~     This is a phase 2 study to evaluate the safety and effectiveness of light-activated~     talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH).~   "
202028|NCT00918021|"~     The aim of this randomized, double-blind study is to verify the hypothesis that clozapine~     monotherapy is as efficient as a combination of clozapine and olanzapine therapy in~     treatment-resistant schizophrenia.~      A third of schizophrenia patients are non -responders to medications used nowadays. These~     patients are usually treated with clozapine, but a large proportion of patients don't recover~     sufficiently. Therefore, these patients are treated with combination of two or more drugs to~     achieve better treatment results. Until now the scientific evidence has been insufficient to~     assess the utility of polypharmacy.~      The aim is to study during 2009 with voluntary patients, if there is any benefit of~     olanzapine augmentation compared with pure clozapine monotherapy. During the study the~     patients are not exposed to any additional intervention. The intervention in this study is~     just to reduce the previously used polypharmacy.~      Methods: This study lasts for 24 weeks. Participants (30) are randomized in one of two~     alternative interventions (A or B) before the study. After 12 weeks the intervention arms~     cross over (from A to B and from B to A).~      Group B: In addition to clozapine, the participants receive their normal dosage of olanzapine~     (=the same as on the hospital ward) for 12 weeks, next the decreasing dosage of olanzapine~     for four weeks and subsequently placebo for 8 weeks~      Group A: : In addition to clozapine the participants receive the decreasing dosage of~     olanzapine for four weeks, next placebo for 8 weeks, after that the increasing dosage of~     olanzapine for four weeks and subsequently the normal dosage of olanzapine for 8 weeks~      The response for the medical treatment is assessed by Clinical Global Improvement Scale~     (CGIS) and Global Assessment of Functioning (GAF) -scale.~      The primary outcomes are GAF and modified CGIS during the parallel phase of the study (the~     first 12 weeks). The second phase (the last 12 weeks) of the cross-over study is used in the~     secondary analysis. The use of additional medication (such as benzodiazepines) is used as a~     secondary outcome measure.~   "
202064|NCT00917540|"~     The purpose of the present study is to develop a biological prognostic index in patients with~     Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to~     NCI guidelines and to prospectively validate the proposed score system based on the~     absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of~     differentiation 38 (CD38) expression, Zap-70 expression and immunoglobulin heavy chain~     variable region (IgVH) configuration.~   "
202239|NCT00915252|"~     The primary purpose of the study is to determine, whether the addition of 5-azacytidine to~     standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results~     (event free survival).~   "
202029|NCT00918008|"~     The purposes of this study is to evaluate a new genetic-based test which will identify~     patients diagnosed with muscle-invasive bladder cancer before their surgery, who might have~     specific genes, which will increase their chances of recurrence of cancer after their~     surgery.~      Some patients who are diagnosed with bladder cancer and have their had bladder removed, will~     have a recurrence of cancer sometime after their surgery. This recurrence is usually caused~     by tumor cells that originated from the bladder tumor and traveled to other parts of the~     body, which is called metastatic cancer. Some patients are more likely than others to have~     metastatic disease. This test may help in identifying these patients who might develop~     metastases from having these specific genes.~   "
202030|NCT00917995|"~     Specific aim:~      To compare patients with colostomies with or without mesh at the primary operation. Primary~     endpoint is the incidence of parastomal hernia requiring surgery.~      All patients at participating centers scheduled for permanent colostomy, after signing~     informed consent and meeting inclusion criteria, will be randomised to formation of a stoma~     with or without mesh.~      If the inclusion criteria is fulfilled and informed consent is signed, the patient is~     randomised preoperatively.~   "
202031|NCT00917982|"~     Vision therapy (VTO) is a group of non-surgical treatment helping patients in 3~     subjects;1)increasing the the visual acuity 2)improving the mechanical skills resulting in~     increasing the power of extraocular muscles,biocular vision,peripheral vision 3) increasing~     the perceptual skills making the brain to percept the colour and visual memory better.In this~     study we are going to compare the effect of vision therapy /orthoptic on motor & sensory of~     the 3 to 7 years old strabismic patients~   "
202032|NCT00917956|"~     IBM is the most common acquired muscle disease occurring over the age of 50. The underlying~     cause remains unknown and there is currently no effective treatment. Pathological studies~     have revealed abnormal collections of proteins in the muscle cells from patients with IBM.~     These include proteins called phosphorylated tau (p-tau). A similar process appears to occur~     in Alzheimer disease, with accumulations of p-tau developing in brain cells. Lithium~     decreases the activity of the GSK, an enzyme that has a key role in the development of p-tau.~     Lithium and other GSK inhibitors have been shown to decrease the accumulation of p-tau in~     nerve cells in animal models of Alzheimer disease. The proposed research is a pilot study to~     see if lithium might be an effective treatment for IBM~   "
202033|NCT00917943|"~     STUDY PURPOSE:~      Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking~     resumption among women who stop smoking during pregnancy.~      Aim 2. To determine the association of baseline risk assessment variables (dependence,~     motivation, self-efficacy, concerns for the fetus, changes in sensory response to tobacco,~     depression, weight concerns, and partner/household smoking and support) with time to~     resumption.~      A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be~     assessed at 4 time-points.~        1. Between 28 and 34 weeks of pregnancy~        2. 6-weeks postpartum~        3. 6-months postpartum~        4. 12-months postpartum~      Women who report not smoking at any of the assessment points will be asked to provide a~     saliva sample for analysis of tobacco constituents and a breath sample to assess carbon~     monoxide. Bio-behavioral and pregnancy-specific factors will be used to triage women to one~     of four levels of stepped-care that includes:~        1. One in-person counseling session and at least one telephone session during pregnancy and~          from 6 to 11 telephone sessions over the first 9-months postpartum.~        2. Risk profiles will be used to match the intervention to each woman's needs.~        3. Women randomized to the control arm will receive the booklet, Forever Free for Baby and~          Me and usual prenatal and postpartum care.~      We are recruiting 400 women for this study from 11 sites in the Durham/ Raleigh/ Chapel Hill~     NC area and Fayetteville NC.~   "
202034|NCT00917930|"~     The purpose of this study is to evaluate the effects of an intensive Cardiac rehabilitation~     program on glucose metabolism of non-diabetic coronary artery disease patients.~   "
202035|NCT00917917|"~     Metabolic syndrome has been defined as a group of associated risk factors for cardio-vascular~     diseases and diabetes. It is usually treated with an association of restrictive diet,~     physical exercise and drugs. Nevertheless the type of exercise associated to reduction in~     cardio-vascular risks is not yet fully defined. Long term effects of such hygienic-diet~     programs are of great importance since it is well-known that compliance to such treatment are~     of short duration, namely when subjects return in routine life. Metabolic syndrome volunteer~     subjects (n=90), aged 50 to 70 yrs will be randomly assigned to 3 groups of investigation.One~     group will perform mostly resistance activity, a second mainly endurance activity and the~     third one will be composed of subjects not exercising a lot. All subjects will have the same~     restrictive diet (500-700 kcal/d) After the initial training (3 weeks), they will return home~     with diet and physical program advises (personal compliance). They will be followed for one~     year (at 3, 6 and 12 months) Such a design may allow to find out the type of activity and~     power that are the best to reduce metabolic syndrome parameters and cardio-vascular risk~     factors.~      The primary outcome variable is the reduction in abdominal circumference, which is the main~     criteria of MS.~   "
202036|NCT00917904|"~     The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use~     by healthy women in South Africa.~   "
202037|NCT00917891|"~     The purpose of this study is to determine whether dapivirine gel 4759 is safe for daily use~     by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.~   "
202038|NCT00917878|"~     The purpose of this study is to determine whether the addition of milk or the milk~     constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and~     inflammatory response.~   "
202049|NCT00917735|"~     RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of~     breast cancer.~      PURPOSE: This phase II trial is studying how well green tea extract works in preventing~     breast cancer compared to a placebo in postmenopausal women with high breast density.~      The investigators have hypothesized that green tea consumption reduces breast cancer risk,~     and this effect is seen primarily in women who have the low-activity COMT genotype. The~     investigators will test this by evaluating the effects of green tea extract on breast cancer~     biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF~     binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding~     globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.~   "
202039|NCT00917865|"~     The purpose of this research project is to test if a compound (chemical substance) has a~     natural tendency to go to prostate cancer. This compound has a small amount of radioactivity~     attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be~     detected on a special imaging device called a PET scanner (positron emission tomography). The~     radiotracer is treated in the body much like an amino acid which is a nutrient required for~     normal functioning. Tumors also use these nutrients. Earlier studies have shown that this~     radiotracer may be able to detect prostate cancer.~      The investigators will perform a study with 20 patients in whom they know have prostate~     cancer after a biopsy and who are scheduled for an operation in which the prostate is removed~     and the nearby lymph nodes are examined. This operation is called prostatectomy. The~     investigators think that this radiotracer can help us determine where exactly the prostate~     cancer is present in the prostate or if it has spread. This information may be useful in the~     future to help with other non-surgical therapy such as radiation beam therapy.~      The investigators will compare the results of the FACBC PET scan to the results of the~     pathology analysis of the removed prostate. In this way the investigators can determine how~     good a test FACBC PET is for finding out where and if prostate cancer is located in the~     prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the~     biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.~      This radiotracer has been tested in over 100 human subjects without incident. It has also~     been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is~     funding this study.~   "
202040|NCT00917852|"~     TAG 08-02 is a prospective, multicenter, single-arm study to evaluate the use of the CTAG~     Device in traumatic transection of the descending thoracic aorta.~   "
202041|NCT00917839|"~     This study is designed to evaluate the neuroprotective effect of lamotrigine in the~     combination of interferon beta 1a once weekly intramuscular in patients with~     relapsing-remitting multiple sclerosis.~   "
202042|NCT00917826|"~     The purpose of this study is to assess whether administration of Arginine Butyrate +~     ganciclovir/valganciclovir for up to three 21-day cycles is tolerable, and results in partial~     or complete responses in patients with EBV(+) lymphoid malignancies.~   "
202043|NCT00917813|"~     The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247~     over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic parameters~     of KD-247 when administered as above; and to assess the effect of KD-247 infusions on plasma~     HIV-1 ribonucleic acid (RNA) load and on CD4+ T cell counts.~   "
202044|NCT00917800|"~     The purpose of the investigation is to verify the efficiency of the HyperQ™ system in~     detecting exercise induced ischemia, with higher specificity and sensitivity than~     conventional ECG Stress testing. The study will be carried out by applying the HyperQ™ system~     during cycle ergometer stress testing in patients who are referred for angiography at the~     Department of Cardiology, Essen University Hospital, Essen, Germany. The HyperQ™ results will~     then be compared to the standard ECG stress test results using the angiography results as the~     gold standard. The study will be considered successful if analysis of the HyperQ provides a~     statistically significant improvement over the diagnostic accuracy of conventional ECG stress~     testing analysis.~   "
202045|NCT00917787|"~     The purpose of this study is to analyze markers of inflammation in blood and in induced~     sputum for the purpose of identifying molecular markers of specific asthma phenotypes. The~     investigators' specific interest is demonstrating that periostin levels are higher than~     normal in blood. The investigators already have solid preliminary data to support this~     hypothesis, and our goal here is to replicate preliminary findings and extend them by~     examining further the characteristics of the asthma subgroup with elevated periostin levels.~   "
202046|NCT00917774|"~     The purpose of this study was to compare functional and radiographic results, range of motion~     of the knee, patient satisfaction, femoral component, revision and complication rates in~     patients receiving either a standard posterior cruciate substituting-flex (LPS-flex) or~     gender-specific posterior cruciate substituting-flex (LPS-Flex) total knee prosthesis.~   "
202047|NCT00917761|"~     Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with~     HBeAg negative CHB, with the overall ALT normalization and HBV viral suppression far from~     satisfactory. Therefore, efforts on the various combinations with the currently available~     drugs are needed to improve the overall response rates. The simultaneous combination therapy~     with oral nucleoside and peginterferon alfa-2a from large-scaled randomized trials did not~     show a superior response rate over peginterferon alfa-2a monotherapy. Recently, sequential~     monotherapy with lamivudine for the first 4 weeks, followed by weekly peginterferon alfa-2a~     has shown favorable HBeAg seroconversion rate over peginterferon alfa-2a monotherapy, based~     on the assumption that early viral suppression by lamivudine can restore the immune function~     to facilitate the later immunomodulatory response by peginterferon alfa-2a. Furthermore,~     prior studies using 24 months of standard interferon alfa showed better ALT normalization and~     HBV suppression rates to 12 months of therapy. With the recent introduction of entecavir, the~     more potent oral nucleoside with few drug resistance, sequential monotherapy with entecavir~     can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate the response of~     peginterferon alfa-2a to achieve HBV viral suppression. Therefore, we aimed to conduct a~     placebo controlled randomized control trial to evaluate if adding entecavir early in the~     course of therapy or extending the treatment duration of peginterferon alfa-2a can improve~     the treatment response.~   "
202048|NCT00917748|"~     The primary objective is:~        -  To determine the efficacy of modafinil in the reduction of fatigue in patients with~          metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy~      The secondary objectives are:~        -  To determine the effect of modafinil on quality of life (QoL) during docetaxel-based~          chemotherapy~        -  To determine the effect of modafinil on patients physical activity level, functional~          status, number of chemotherapy cycles tolerated, sleep disturbance and depression,~          during docetaxel-based chemotherapy~        -  To investigate the impact of tumour type, patient physical activity level, functional~          status, sleep disturbance and depression on the efficacy of modafinil at improving~          fatigue and quality of life during docetaxel-based chemotherapy.~        -  To determine the safety and tolerability of modafinil during docetaxel-based~          chemotherapy~   "
204404|NCT00886145|"~     The purpose of this research study is to determine the effect of mechanical vibrations on~     bones of persons with spinal cord injury.~   "
202050|NCT00917722|"~     In this study, the investigators will follow patients who have had stimulators implanted, at~     their usual clinic follow-up appointments 3, 6, 9 and 12 months after surgery. It is typical~     at these appointments for patients to be off medication and for the stimulators to be turned~     off to observe disease progress and test stimulator effectiveness. Also as part of standard~     clinical practice, stimulator settings are adjusted for optimal benefit to motor symptoms.~     Only patients who already have implants will be invited to participate in this study, and no~     changes to stimulator settings are made for the purposes of this study. Stimulator settings~     are changed based on clinical evaluation of motor symptoms, and this study has no bearing on~     how stimulators will be set nor how often they will be set.~   "
202051|NCT00917709|"~     The general aim of this research project is to determine the relationships between~     alterations of central cholinergic (ACh) and dopaminergic (DA) systems and neurobehavioral~     features of dementias with Lewy bodies (DLB).~      Both clinical and neurochemical data support the view that DLB is not a homogeneous entity~     and it can be hypothesized that differential alterations of central ACh systems (i.e.~     anterior vs posterior vs striatal interneurons) in association or not with a DA nigrostriatal~     dysfunction could partly support the clinical heterogeneity observed in this disease. ACh in~     vivo imaging has been relatively underutilized to date and to our knowledge only on the~     postsynaptic side. Furthermore, ACh/DA interactions and their relationships with the~     symptomatology of DLB and related pathologies (PDD) had never been investigated.~   "
202052|NCT00917696|"~     This study will evaluate ATP-induced Pain (AIP) and ATP-induced dermal vasodilation (AIDV) as~     target engagement tools for future development of analgesics.~   "
202053|NCT00917683|"~     Previously it has been shown that Familial Encephalopathy with neuroserpin inclusion bodies~     (FENIB) patients develop abnormalities that partially overlap with Autism Spectrum disorders~     (ASD), confounded with additional features that could be explained by inclusion body~     formation not expected in subjects with inclusion body forming SERPINI1 mutations. There is~     no described human neuroserpin deficiency phenotype. The neuroserpin knockout mouse phenotype~     also suggests a possible overlap with autism. Neuroserpin could contribute directly at the~     synapse or through altered neuron migration during early development leading to the~     underconnectivity that underlies autism by potentially contributing to the excess of short~     connections and not enough long ones seen in autistic brains, possibly due to an imbalance in~     pruning of neurons and synapses early in life. It is thus proposed to sequence the~     neuroserpin gene in initially 20, and subsequently up to 100 idiopathic autistic patients~     selected as having the language impairment and perseveration endophenotypes.~   "
202054|NCT00917670|"~     Ultrastructural analysis of trabeculectomy specimens of patients with uveitic secondary~     glaucoma.~      To evaluate morphological changes and to compare to primary open angle glaucoma patients.~   "
202055|NCT00917657|"~     To assess the efficacy, predictability, stability and safety of corneal wavefront-guided~     photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial~     keratotomy (RK).~   "
202056|NCT00917644|"~     To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial~     atorvastatin tablets (Lipitor®).~   "
202057|NCT00917631|"~     A rising number of preterm twins, at high risk of undergoing repeated medical procedures~     often without adequate pain relief, are being admitted to Neonatal Intensive Care Units.~     Skin-to-skin contact between mothers and their infants during painful procedures has been~     shown to decrease pain and help them stabilize more quickly afterwards. The main question of~     this study is whether the contact of a twin could provide a similar form of comfort.~     Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel~     stick while being cared for together (co-bedding) or separately. Primary outcome will be~     physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care~     practices to include co-bedding may help twins tolerate and recover from painful procedures.~     Findings will help care providers make recommendations for at risk twins experiencing~     procedural pain and add to existing theoretical models with respect to the exact mechanism of~     comfort through touch.~   "
202058|NCT00917618|"~     Hypothesis: Group cycling classes (Spinning®) will improve pain and functional outcomes in~     patients with knee osteoarthritis~      Methods: Patients with symptomatic knee OA will be randomized to active Spinning® classes 2-3~     per week or control group for 3 months. Outcomes including gait speed, WOMAC, KOOS, KOS, and~     VAS pain at rest and after 6 min walk will be performed at baseline and at 12 weeks.~   "
202059|NCT00917605|"~     This project consists of two parts: Robotic Rehabilitation Trials, and Study of Outcome~     Predictors and Clinimetric Attributes. In the first part of study, the investigators aim to~     (1) investigate the treatment effects of robot-assisted therapy (RAT) in patients with stroke~     on various outcomes, (2) test the dose-response relations by using two different intensities~     (higher versus lower intensity RAT), and (3) investigate the effects of the training~     intensity on a biomarker of oxidative stress. Treatment outcomes will encompass the spectrum~     of functioning including motor ability, motor control strategies, basic/extended daily~     functions, mobility, community reintegration, quality of life, and biomarker (8-OHdG). In the~     second part of study, the purposes are to define the appropriate populations for RAT and to~     examine the clinimetric properties of clinical measures relevant for use in robotic~     rehabilitation research. the investigators will identify the clinical predictors that will~     potentially influence the functional outcomes after interventions. Finally, the investigators~     will examine and compare the clinimetric properties (e.g., validity and responsiveness) of~     the clinical measures of rehabilitation outcome to inform selection of test instruments that~     may detect clinically meaningful change after rehabilitation therapy.~   "
202060|NCT00917592|"~     Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an~     enormous diversity in clinical practice. The investigators' aim was to demonstrate that~     uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a~     short hospital admission.~   "
202061|NCT00917579|"~     • To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial~     atorvastatin tablets (Lipitor®).~   "
202062|NCT00917566|"~     This study indented to evaluate the use of Optical laryngoscope in pediatric~   "
202063|NCT00917553|"~     This 24 month randomized research study will evaluate whether doxycycline can slow the~     deterioration or improve retinal function among patients with mild to moderate~     non-proliferative diabetic retinopathy.~   "
202065|NCT00917527|"~     The aim of this prospective study is to investigate the prevalence of endothelial dysfunction~     in subjects with family history of premature coronary heart disease. At the same time, the~     effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will~     be evaluated.~   "
202066|NCT00917514|"~     This is a study of the electronical dosing tool MedicPen and it's qualities with regards to~     user friendliness and medication compliance.~   "
202067|NCT00917501|"~     The purpose of this study is to see if taking a substance called omega-3 fatty acids is~     effective, safe, and well-tolerated for treating adolescents with major depressive disorder~     (also called simply depression or clinical depression). Another purpose of this study is~     to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient~     more or less likely to develop mania (i.e. periods of irritability or extreme silliness~     accompanied by decreased need for sleep, risky behaviors, feeling like the patient has~     special abilities, inability to sit still, and rapid speech) in the future. Yet another~     purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3~     fatty acids are not United States Food and Drug Administration (FDA)-approved to treat~     depression in adults or in children and adolescents.~      Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea~     foods, though they are also found in other food sources such as flax seed. Omega-3 fatty~     acids have been shown to play a role in affecting brain chemicals responsible for regulating~     mood and have been found to reduce symptoms of depression in medicated-patients with major~     depressive disorder.~      By completing this study, the investigators hope to better understand who benefits from~     treatment, why they do or do not respond to medications, and who is at greater risk for~     developing further mental illness. With this information, the investigators hope to be able~     to improve treatment and outcome in people with major depressive disorder.~   "
202068|NCT00917488|"~     The main purpose of the trial is to prove the therapeutic value of the product and enable an~     effective and safe dosage schedule to be recommended~   "
202069|NCT00917475|"~     With advances in medicine and medical technology, premature infants born as early as 24 weeks~     of gestation and with birth weight less than 1000 grams are surviving today. Preterms are~     born with immature biological systems. Given their biological vulnerabilities, preterm~     infants are at risk for a variety of health and developmental problems.~      As a group, preterms show developmental delays in physical growth, motor skills, attention,~     social communicative skills, intelligence, language, academic performance, and later behavior~     problems. Furthermore, research indicates that preterms are difficult social partners for~     their parents.~      Despite biological insults and relational difficulties, research also shows that the~     development of premature infants appears to be facilitated by sensitive and responsive~     parenting. Little attention, however, has been paid to understand the social risks faced by~     preterm infants.~      The proposed research, therefore, is designed to:~        1. understand the extent to which neurophysiological risk may affect preterm infants'~          socioemotional development,~        2. explore the role of maternal social support, sociopsychological stress, and perception~          of infant vulnerability in the socioemotional development of preterm infants varying in~          biological risk,~        3. examine the role of social support in buffering stress in mothers of preterm infants,~          and~        4. evaluate the role of maternal stress, coping, and support in preterm infants'~          socioemotional development.~      This study will include preterm infants recruited from the National Taiwan University~     Hospital at term and 12 months of corrected age. Infants will be examined for physical~     growth, neurobehavioral development, and mother and infant interaction at term. The growth~     measures including weight, height and head circumference will be assessed. Interaction~     between mother and infant will be investigated by observing the interaction between infants~     and their mothers in feeding and skin to skin contact conditions. Mothers' psychosocial~     stress and social support will be obtained via questionnaires.~      It is expected that preterm infants' physical growth and neurobehavioral development as well~     as mothers' psychosocial stress and social support are associated with the quality of~     mother-infant interaction.~   "
202070|NCT00917462|"~     Sorafenib is a drug being studied for the treatment of cancer. Sorafenib has been shown to~     block certain proteins on the surface of some cancer cells called growth factor receptors.~     Blocking these growth factor receptors can slow or stop cancer cell growth.~      Sorafenib is also known as Nexavar®. It has been studied in other types of cancers, including~     kidney cancer, and has been approved by the Food and Drug Administration (FDA) for treating~     advanced kidney cancer. Because it is not approved by the FDA for treating esophageal cancer,~     it is considered an experimental treatment.~      The purpose of this study is to determine what effects sorafenib has on advanced esophageal~     cancer. These effects include whether sorafenib can shrink the tumor or slow down its growth~     and what side effects sorafenib will have on the tumor.~   "
202071|NCT00917449|"~     Aim~      The principal objective of this project is:~      • To evaluate the efficacy of long term (18 months) L-Arginine therapy in preventing or~     delaying clinical onset of type 2 diabetes mellitus in subjects with impaired glucose~     tolerance (IGT) and Metabolic Syndrome.~      Secondary end points are:~        1. To define if a long term treatment with L-arginine is able to ameliorate insulin~          sensitivity and endothelial dysfunction in this population.~        2. To find new risk profiles and candidate genes able to define the sub-group of patients~          at higher risk to develop type 2 diabetes mellitus.~      Methodology This is a double blind, parallel, one centre study to determine if long term oral~     L-arginine administration is able to delay or prevent type 2 diabetes mellitus in patients~     with Metabolic Syndrome. Two hundred and ninety four subjects were recruited at the~     Cardio-Metabolic and Clinical Trials Unit of the San Raffaele Scientific Institute. One~     hundred and forty two patients were randomized to enter the study and assigned to two arms:~     oral L-arginine (6.4 g/die) or placebo, in addition to diet and physical exercise. The~     treatment were maintained for 18 months. Visits were performed every 3 months for clinical~     evaluation, blood samples, treatment supply and collection of data on adverse events.~     Furthermore, patients were contacted every month by telephone to evaluate the accurate~     continuation of the study and they were instructed to phone to the centre in case of possible~     adverse events.~      An OGTT were performed before the enter into the study and at the end of the study period. An~     additional OGTT were performed at an intermediate visit if fasting glucose levels were more~     than 126 mg/dl. A diabetic response caused the end-point of the patient. Metabolic, hormonal~     and endothelial activation and inflammation parameters were measured. Evaluation of~     endothelium-mediated and non-endothelium-mediated vasodilatation were performed by strain~     gauche plethysmography evaluating forearm blood at the basal state. in post-ischemic~     conditions and after nitroglycerine administration.~      Before the enter into the study, an additional blood sample were drawn for DNA extraction and~     candidate genes variants evaluation. Before the enter into the study and at the end of the~     study period, gene expression for inflammation were measured on mRNA extraction on~     endothelial progenitor cells.~   "
202072|NCT00917436|"~     To assess two regimens of thiocolchicoside injection and capsule in combination with either~     diclofenac or ibuprofen in patients with acute low back pain.~   "
202073|NCT00917423|"~     This study will determine the importance and the level of physical activity among women with~     anorexia nervosa, both during inpatient treatment and 1 year after hospital discharge.~   "
202074|NCT00917410|"~     The study aims at providing information on how the Short Message Service (SMS) tool~     influences self-management in asthma patients and to assess the resulting health related~     effect. A wide range of models and theories exist in the compliance area, such as technical~     models, communication models, cognitive models and self-management models and theories. The~     use of some of these theories and models will serve as theoretical and explanatory tools for~     studying how and why the SMS tool influences the patient's self-management.~      Objective:~      The objective of this study is to assess the health-related effects of a SMS compliance and~     monitoring system for optimized asthma treatment in a controlled trial setting.~   "
202240|NCT00915239|"~     The purpose of this study is to determine whether proton pump inhibitor (PPI) induced~     hypersecretion leads to acid related symptoms after treatment in healthy volunteers.~   "
202075|NCT00917397|"~     The purpose of the study is to investigate the effect of treatment of traumatized refugees~     with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point~     towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy~     being the most effective treatments of PTSD, but very little evidence of treatment effects~     exist for the group of multitraumatized refugees. This study therefore seeks to investigate~     the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or~     Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual~     will undergo treatment. They will be randomized to 4 different groups: antidepressants,~     psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures~     include symptoms, life quality and function. Patients with a diagnosis of drug abuse or~     psychosis will not be included. The hypothesis is that a combination of antidepressants and~     psychotherapy will be more effective than either of the two treatment regimes on their own.~   "
202076|NCT00917384|"~     The purpose of this study is to gather information about the use of an investigational drug~     called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.~   "
202077|NCT00917371|"~     Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%),~     early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high~     heritability. Pharmacotherapy (methylphenidate and atomoxetine) has been proved to be the~     most effective treatment for ADHD. Gau (PI) has done extensive research on ADHD and published~     7 SCI papers in ADHD pharmacotherapy. The PI published the first paper in the effectiveness~     of atomoxetine in improving executive functions among 30 boys with ADHD in the world~     (International Journal of Neuropsychopharmacology, 2009 Oct 23:1-14. [Epub]). Due to its~     lifelong impairments up to adulthood, adult ADHD has drawn much more attention in Western~     studies in the past decade; however, there is lack of such information in Asian population~     except the PI's three SCI papers on adult ADHD. Because little is known about atomoxetine~     effect in adults with ADHD except symptoms reduction, this proposal aims to investigate the~     efficacy of atomoxetine beyond symptoms improvement. The significance of this project is its~     novelty and research and clinical relevance because there is lack of information regarding~     long-term effect of atomoxetine on neuropsychological and brain imaging functions on adults~     with ADHD, a high-prevalent mental disorder with long-term impairment in adults.~   "
202078|NCT00917358|"~     Interferon-based monotherapy has been considered effective to treat acute hepatitis C in~     ordinary patients. However, the efficacy of this treatment has not been evaluated in~     prospective interventional studies for dialysis patients. The aim of the study is the~     evaluate the efficacy of peginterferon alfa-2a monotherapy for 24 weeks in this special~     clinical setting, and concomitantly evaluate retrospectively the dialysis patients with acute~     hepatitis C who did not receive intervention as the reference.~   "
202079|NCT00917345|"~     Background: The most common pharmacologic test for diagnosis of primary aldosteronism (PA) is~     administration of captopril to examine whether abnormal aldosterone to plasma rennin activity~     (PRA)(ARR) persists, although active rennin concentration (ARC) in contrast to PRA may offers~     advantages with regard to processing and standardization.~      Objective: To assess whether post captopril ARC offer any additional advantage in screening~     primary aldosteronism (PA) than PRA and establish thresholds for the diagnosis using ARC.~   "
202080|NCT00917332|"~     The purpose of this study is to determine whether relaxation and guided imagery techniques~     are effective in reducing childbirth pain.~   "
202081|NCT00917319|"~     Bundling infection control interventions should decrease incidence of Healthcare-Associated~     Infections in General Medical Wards at Siriraj Hospital, Bangkok, Thailand~   "
202082|NCT00917306|"~     The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when~     applied to an area of skin containing 4-8 AK lesions on non-head locations.~   "
202083|NCT00917293|"~     The primary objective is to assess the safety and effectiveness of Pyridoxal 5'-Phosphate on~     the reduction of expressed symptoms of tardive dyskinesia in patients with schizophrenia and~     schizoaffective disorders.~   "
202084|NCT00917280|"~     The overall purpose of this research is to learn how Parkinson's disease affects thinking and~     memory in everyday life. Participation will involve thinking tests, questionnaires and~     interviews about thinking and activities in everyday life.~   "
202085|NCT00917267|"~     Previous studies have suggested that a once-weekly formulation of exenatide may provide~     sustained glycemic control. These previous studies of exenatide once weekly have been~     conducted in non-Asian populations, so this study has been developed to support the local~     regulatory requirements of China, Korea, Japan, India, and Taiwan.~   "
202086|NCT00917254|"~     The purpose of this study is to examine the superiority of YM150 to the placebo and to~     evaluate the dose-dependent response of YM150 in patients undergoing elective total knee~     replacement surgery.~   "
202087|NCT00917241|"~     Antithyroid drugs are widely used in treatment of Graves' disease (GD), but after therapy~     withdrawal, relapse rate is very high. The aim this trail is to evaluate the effects of~     intrathyroid injection of dexamethasone combined with antithyroid drugs on patients with~     newly diagnosed GD.~   "
202088|NCT00917228|"~     This study evaluates the feasibility of a biofeedback system aimed at reducing overpressures~     during seated posture. The system consists of (1) a pressure sensors map, (2) a laptop that~     couples sensors with actuators, (3) a Tongue Display Unit (TDU) consisting of a wireless~     circuit embedded in a dental retainer with a matrix of electrodes. The principle of this~     biofeedback system consists in (1) detecting overpressures in people who are seated over long~     periods of time, (2) estimating a postural change that could reduce these overpressures and~     (3) communicating this change through directional information transmitted by the TDU.~      It is hypothesized that overpressures are diminished after biofeedback.~   "
202089|NCT00917215|"~     What is the trend of changes in asthmatic patients' daily peak expiratory flow (PEF)~     variability, pulmonary function, and quality of life (QOL) with acupuncture treatment on~     specific acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1) compared with minimal~     acupuncture treatment (sham control group) on non-acupoints, and no acupuncture treatment~     (waiting list control group)?~   "
202216|NCT00915564|"~     The purpose of this study is to evaluate the effect of steady-state (constant concentration~     of medication in the blood) TMC435 (150 mg, once a day) on the steady state pharmacokinetics~     (what the body does to the medication) of R- and S-methadone.~   "
202090|NCT00917202|"~     Design: Single-centre, controlled study in adults with uncomplicated falciparum malaria in~     the Nouna Health District, north-western Burkina Faso~      Phase: Phase II~      Objectives: The primary objective of this trial is to study the efficacy of different~     methylene blue regimens given to adults with uncomplicated falciparum malaria in an African~     area of high malaria transmission intensity.~      Population: Male adults with uncomplicated malaria from Nouna town.~      Sample size: N= 60 (n=20 for each group; three different dosing regimens of MB).~      Treatment: The participants in the three different MB regimens will receive orally twice~     daily 390 mg MB (total daily dose 780mg) over 7,5 or 3 days respectively. Treatment with the~     five (three) day regimen will only start after all patients of the seven (five) days regimen~     have been followed up until day 3.~      Endpoints: The primary endpoint is the adequate clinical and parasitological response (ACPR)~     rate on day 28. Secondary endpoints are the number of adverse events (AE) after drug intake~     until day 28, clinical and parasitological failure rates on day 14 and 28, changes in~     haemoglobin/haematocrit until day 28, and fever and parasite clearance time.~   "
202091|NCT00917189|"~     This study will test a computer-based treatment for youth with the genetic disorder~     velocardiofacial syndrome (VCFS) to help them improve skills in memory, attention, and~     executive functioning.~   "
202092|NCT00917176|"~     The aim of this study is to investigate whether greater occipital nerve stimulation is~     effective in the treatment of fibromyalgia related pain. The study uses sub sensory threshold~     stimulation and placebo stimulation in order to investigate whether sub-threshold stimulation~     is feasible in a placebo controlled study.~   "
202093|NCT00917163|"~     The objective of Series III Run-In Trial is to compare the performance and efficacy of the~     Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect~     to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power~     to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of~     the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.~   "
202094|NCT00917150|"~     To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of~     trough FEV1 over time as the primary endpoint.~   "
202095|NCT00917137|"~     The main purposes of this study are to assess the performance characteristics of~     transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and~     to identify the predictor variables of a positive aspirate.~   "
202096|NCT00917124|"~     It is previously reported that the cerebral oxygen desaturation during cardiac surgery is~     associated with an increased incidence of cognitive impairment. The aim of this study is to~     determine whether intraoperative monitoring and predetermined interventions protocol to~     improve cerebral oxygenation during coronary artery bypass surgery provides benefits in~     neurocognitive functions.~   "
202097|NCT00917111|"~     The purpose of this study is to evaluate the effect of four times a day treatment with nasal~     carbon dioxide in patients with Seasonal Allergic Rhinitis symptoms.~   "
202098|NCT00917098|"~     This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in~     children and adolescents.~   "
202099|NCT00917085|"~     To see if infant outcomes will improve when mothers are helped to hold their preterm infants~     skin-to-skin as soon as possible after birth and as often as possible and for as long as~     possible each time during the next five days.~   "
202100|NCT00917072|"~     Study the feasibility of different educational modalities to improve resident handoff of~     patient information b) Determine whether different educational modalities (powerpoint vs.~     simulation workshop) lead to improved educational and (surrogate) clinical outcomes~        1. Educate residents on the content and process of quality handoffs (Medical Knowledge)~        2. Educate residents on good communication skills (Communication competency)~        3. Improve perceived continuity of patient care, decrease adverse events related to~          transfer of care. (Patient safety competency)~        4. Increase providers (night residents) satisfaction with the continuity of care during~          handoffs. (system-based practice/ Practice-based learning)~   "
202101|NCT00917059|"~     This study will examine whether measures of brain electrical signals taken after a week of~     antidepressant medication treatment can predict whether a full treatment regimen will be~     effective.~   "
202102|NCT00917046|"~     This protocol describes a randomized multicenter clinical trial designed to test the~     hypothesis that a 12-week program of high-intensity interval training (HIIT) yields larger~     beneficial effects in stable heart failure patients than current practice, defined as either~     a similar training program with the same volume of moderate continuous training (MCT) or a~     recommendation of regular exercise at moderate intensity at individual choice (RRE).~   "
202103|NCT00917033|"~     The purpose of this study is to examine whether orotracheal intubation in morbidly obese~     patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the~     Macintosh direct laryngoscope.~   "
202104|NCT00917020|"~     The purpose of this study is to evaluate the effect of as-needed treatment with nasal carbon~     dioxide in patients with Seasonal Allergic Rhinitis symptoms.~   "
202105|NCT00917007|"~     The purpose of this research study is to more accurately measure the amount of true red blood~     cell breakdown (hemolysis) in newborn babies with potentially problematic blood type mismatch~     with their mothers (ABO incompatibility), and to examine how the true level of red blood cell~     destruction relates to other laboratory tests obtained in newborns with jaundice.~      A better understanding of the true amount of red blood cell destruction that is caused by~     blood type mismatch, as well as how it relates with other laboratory tests ordered for ABO~     incompatibility and red blood cell destruction, would help avoid unnecessary testing,~     treatment and prolonged hospital stays in such babies.~   "
202123|NCT00916773|"~     Purposes:~        1. To investigate whether patients with severe obstructive sleep apnea syndrome (OSAS) are~          at higher risk for exercised-induced bronchoconstriction (EIB) due to baseline airway~          inflammation compared with age, gender, and body mass index (BMI)-matched controls.~        2. To investigate the effect of 3-month continuous positive airway pressure (CPAP) therapy~          on EIB for patients with severe OSAS.~   "
202217|NCT00915551|"~     This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when~     applied to an area of skin containing 4-8 AK lesions on the face or scalp.~   "
202106|NCT00916994|"~     Title: One-arm, international, multi-center with competitive recruitment, prospective study~     to assess the safety and efficacy of OrthoSpace's InSpace™ in rotator cuff tear subjects~     scheduled for surgery of the rotator cuff - A pivotal study~      Device: OrthoSpace's Biodegradable Implanted Balloon (InSpace)~      Study population: Rotator Cuff tear subjects scheduled for arthroscopy.~      Number of subjects: Up to 70 subject for data analysis.~      Number of sites: At least 4 sites in Israel.~      Main Inclusion criteria: Informed consent, diagnosed with Rotator Cuff tear.~      Main Exclusion criteria: Former surgery on affected shoulder, sever illness, significant~     shoulder co morbidities.~      Follow up period: 12 months. Visits at hospital before discharge at 1-2 days post~     implantation, 7-10 days post implantation, 3 weeks post implantation, 6 weeks post~     implantation, 3,6 and 12 months post implantation.~      Primary goal: To assess the safety of the SpaceGuard in Rotator Cuff tear subjects.~      Secondary goals: To assess the effectiveness of the SpaceGuard in the study population. The~     effectiveness will be assessed by terms of good positioning of the SpaceGuard and subsequent~     follow-up non migration, surgeon satisfaction, pain relief and time to pain relief, Range of~     Motion (ROM) and time to ROM with the SpaceGuard.~      Primary end point: Serious Adverse Event rate related to the device and/or system~     complication.~      Secondary end points: Surgeon dissatisfaction following the deployment of SpaceGuard,~     migration of the balloon shown by ultrasound/ X-ray/MRI at relevant follow-up visits, lost of~     ROM and pain enhancement.~   "
202107|NCT00916981|"~     Treatment of nonunion, delayed union and malunion fractures of long bones remains~     problematic. The definition of nonunion is a failure of the fracture to heal in six months in~     a patient in whom progressive repair had not been observed radiographically between the third~     and sixth month after the fracture. First of all good surgical techniques are stable~     immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is~     required. Numerous techniques have been developed ranging from invasive interventions~     (including internal fixation with the use of bone graft or bone graft substitutes) to non~     invasive procedures (ultrasound and pulsed electromagnetic fields).~      Recently, autologous cell therapy was presented as an interesting approach. The concept of~     such therapies is based on the effect of stem cells presented in the bone marrow and able to~     be transformed in osteoblast cells. The percutaneous technique of autologous bone-marrow~     grafting is a minimally invasive alternative able to produce a good healing of the fracture.~     The efficacy is dependent of the concentration in progenitor cell reinjected. An optimization~     of this type of treatment could be achieved using a technique to increase the differentiation~     of the bone marrow cells in preosteoblasts before the injection in situ by an adequate~     culture. Therefore we would like to start a pilot open study on the feasibility and the~     efficacy of implantation of preosteoblasts into nonunion. Two different presentations exist:~     the atrophic and the hypertrophic pseudarthrosis in relationship with radiological features~     of bone proliferation at the tip of bone fragments. Some data support that atrophic and~     hypertrophic nonunion fractures could have different physiopathological factors. So, in a~     first time we only would evaluate the atrophic form and to determine in an open study the~     effect of the implantation of preosteoblasts into atrophic nonunion.~   "
202108|NCT00916968|"~     The purpose of this prospective, randomized study was to compare functional outcome,~     radiographic results, range of motion, patients satisfaction, and fit of the femoral~     component in patients receiving either a standard posterior cruciate-retaining high-flexion~     (CR-flex) and gender-specific CR-flex total knee prostheses.~   "
202109|NCT00916955|"~     The purpose of the project is the determination of how the deletion of DNA from chromosome 22~     at the q11.2 band causes the phenotypes observed in velo-cardio-facial syndrome (VCFS). In~     other words, the purpose remains genotype-to-phenotype matching. Current methods includes the~     use of whole genome chips and microarray analysis. Blood samples are collected for DNA from~     every patient who consents from the VCFS Center at Upstate Medical University. They are~     examined for phenotypic features consistent with our typical clinical evaluation. The~     information from these examinations will be entered anonymously into a database. Genomic~     information is then matched to clinical phenotype with appropriate statistical method~     applied.~   "
202110|NCT00916942|"~     This study is an open-label multi-center to evaluate the tolerability of treatment with~     NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an~     open-label study. No hypothesis testing will be performed.~      Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate~     for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to~     a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for~     60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on~     chronic pain medication regimens, but currently will not be using any topical pain~     medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol,~     methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or~     capsaicin.~   "
202111|NCT00916929|"~     To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude~     Medical cardiac devices.~   "
202112|NCT00916916|"~     Recently lanreotide (a somatostatin analog) has come into the US marketplace as a~     commercially available medication approved by the FDA for the treatment of acromegaly. Blood~     levels in patients getting this drug are unknown and it may be critical to know the levels in~     patients whose symptoms are poorly controlled.~      This is a clinical study of a medical device where the following condition is met: This is~     research on a medical device for which an investigational device exemption application (21~     CFR Part 812) is not required.~      The study is exempt from IDE requirements under 21 CFR 812.2(c)(3):~      The participants will be 10 CSMC patients who are taking Lanreotide for clinical purposes.~     After receiving an information sheet and providing verbal consent, the participants will go~     to their routine blood draw. At this time, they will have an additional 10 cc plasma drawn,~     which will be sent to Intersciences Institute in Inglewood California to have the lanreotide~     plasma levels measured.~      The key points of this study are:~      Patients will have blood drawn at the same time as they are having blood drawn for routine~     care to avoid unnecessary sticks.~      No patient identifiers will be sent to the lab or to any investigators- all plasma tubes will~     be coded by ISI as a kit and these kits will be given to the physicians. In turn the~     physician will give the kit to the patients who wish to have their levels measured and the~     patient will take the kit with them to their routine blood draw. Following the drawing and~     processing of the blood we will request that the lab just drop the coded plasma tube (and the~     patient's height weight and monthly lanreotide dose) into the mail in the prepaid mailer. The~     only information that the investigators will receive is the patient's height, weight and~     monthly lanreotide dose and the plasma lanreotide level.~      No more than 10 cc of blood (a couple of tablespoons) will be drawn for lanreotide~     measurement.~      Whenever possible plasma (which would otherwise be discarded) will be used rather than~     freshly drawn blood.~      All plasma will be assayed at ISI.~      The patient will not be charged for the lanreotide assay, an investigational assay. The assay~     is currently investigational and does not have a maker at this time.~   "
202124|NCT00916760|"~     The objective of this trial is to assess the clinical efficacy of the modified extract~     (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria~     Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis~     ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating~     the score regarding symptoms and consumption of the medication.~   "
202237|NCT00915278|"~     Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main~     objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose)~     in cancer patients pre treated or unresponsive to standard therapies.~   "
202113|NCT00916903|"~     This is a a study to identify inherited disease genes. The study will use molecular~     techniques to map genetic diseases using techniques such as Affymetrix SNP chips. The~     powerful combination of the information generated by the Human Genome Project and technical~     advances such as microarrays enables attempts to identify genes responsible for inherited~     disorders more possible than ever before. Starting with even modest pedigrees of only a few~     individuals, or even single individuals, it is possible to identify the gene(s) involved. It~     is proposed to collect up to 20 ml of peripheral blood and/or buccal cell samples from~     subjects and relevant family members. Currently the following disorders are approved for~     investigation.~      The current list of disorders:~      Aarskog-Scott syndrome, Café-au-Lait spots, Cerebral cavernous malformation, delXp, del2q,~     del10p, del11q, del12p, del13q, del14q, del16q, del17q, del18q, del Xp21, Choreoathetosis,~     Congenital Vertical Talus (CVT), Clubfoot, Tarsal coalition and other congenital limb~     deformities, Cystic Fibrosis (CF)-like disease, Desbuquois syndrome, Droopy Eyelid syndrome~     (Ptosis), Fanconi-Bickel syndrome (FBS), FENIB (familial encephalopathy with neuroserpin~     inclusion bodies), FG syndrome, Idiopathic generalised epilepsy (IGE), Renpenning syndrome,~     transient neonatal diabetes with 6q UPD, translocation (13;14), translocation (3;8),~     translocation (2;18), Uncharacterized familial dementia and X-linked mental retardation~     (XLMR).~   "
202114|NCT00916890|"~     Aim of this project is to customize the choice of the strong opioid in the treatment of~     cancer chronic pain through the identification of patient clinical history and pain~     characteristics, moreover in the analysis the investigators will also correlate the clinical~     efficacy and safety of opioid treatment with pharmacokinetic and pharmacogenetic patterns in~     order to identify variables able to predict the efficacy of the treatment or the patient~     susceptibility towards a specific treatment.~      Furthermore with this study the investigators want to identify the pharmacogenomic~     characterization responsible for pharmacokinetic variability in the conversion between~     morphine and other opioids, in order to validate the currently available conversion tables~     from a pharmacokinetic viewpoint, estimating the influence of the most common genetic~     polymorphisms, and if this characterization could be useful and cost-effective. This study~     will also focus on the specific clinical-pharmacological response in the elderly and between~     male and female and on the interactions between opioids and those anticonvulsant and~     antidepressant drugs routinely used in the pain therapy (study of pharmacovigilance).~   "
202115|NCT00916877|"~     Though brain metastases are a risk in all patients with breast cancer, those with HER-2~     overexpression are at significantly greater risk. One series estimated a 30% incidence of~     brain metastases in this population, while another study found an incidence of approximately~     40%. Traditional systemic therapies do not cross the blood brain barrier to any significant~     degree or at all, but radiation treatment can be effective in the treatment of intracranial~     metastases.~   "
202116|NCT00916864|"~     The aim of the study is to estimate the diagnostic accuracy of a combined biomarker test~     (including NMDA-Receptor fragments [NR2-peptide] and Glial fibrillary acidic protein) used to~     differentiate between cerebral ischemia and intracerebral hemorrhage in patients with acute~     hemispheric stroke.~   "
202117|NCT00916851|"~     The behavioral patterns, neurocognitive and social impairments, and high heritability are the~     common characteristics of autism spectrum disorders (ASD) and attention-deficit hyperactivity~     disorder (ADHD), the two most common early-onset neuropsychiatric disorders. Little is known~     about the discriminative validity between these two disorders. As brain imaging studies have~     been recognized as an important biological tool to validate disease involving the brain, no~     studies have employed this approach to distinguish the brain functioning between ASD and~     ADHD. Moreover, there is lack of comprehensive data of environmental, behavioral,~     neurocognitive, neuroimaging, and genetic data for healthy children. Hence, we propose this~     program project involving expertise researchers in the fields of child psychiatry and~     psychology, psychiatric genetics, and brain imaging studies to elucidate the~     neuropathophysiology and genes & environment interactions of ASD and ADHD as comparing to~     healthy controls by integrating data from environments, behavioral phenotypes,~     endophenotypes, and genotypes in one study.~   "
202118|NCT00916838|"~     125 children with Type 1 Diabetes mellitis (T1DM) between 4 and 16 were recruited and 62~     healthy siblings also enrolled in the study.~      Children with T1DM and sibling controls ages 4 to 16 were assessed on memory and executive~     control skills at entry to the study (Test 1) and after two years of close monitoring for~     blood sugar events (Test 2). Diabetic children have their blood sugar tested directly before~     and after cognitive testing to ensure their blood sugar is within range during the testing.~     The 2-year follow-up period involves parents/child reporting any severe diabetic episode and~     periodically providing the results of the diabetic child's usual blood tests from their~     glucose monitoring device.~      Children 7 and older also underwent high resolution MRI scans.~   "
202119|NCT00916825|"~     About 1/3 of newly diagnosed breast cancer patients are mothers of children who still live at~     home. They face additional challenges and stress, their children are also affected by the~     mother's illness. The oncological rehabilitation programme getting better together focuses~     on these special family needs. This waiting-control-group study examines the effectiveness of~     the intervention by accompanying the patients and their children over the course of a year~     and assessing their quality of life and psychological health.~   "
202120|NCT00916812|"~     This is a study to detect the sensitivity of thyromental distance ratio as a single predictor~     for difficult intubation in patients undergoing cesarean section under general anesthesia.~   "
202121|NCT00916799|"~     Looking at the use of home telehealth equipment and it's place in self management and~     education in patients who suffer moderate to severe Chronic Obstructive Pulmonary Disease~     (COPD). The patients in this group would be those patients who traditionally suffer from~     emphysema, and/or chronic bronchitis.~   "
202122|NCT00916786|"~     The ultimate goal of this study is to find the association between specific polymorphism of~     candidate genes and medication response in attention deficit hyperactivity disorder (ADHD)~     patients. These results will lead the investigators' team: (1) to resolve controversies over~     inconsistent findings in previous pharmacogenetic studies; (2) to study the medication effect~     on the neuropsychological functions that are useful candidate endophenotypes for ADHD; (3) to~     delineate the nature and the effect of gene-gene interaction in the drug response of ADHD~     patients.~   "
202125|NCT00916747|"~     Hutchinson-Gilford Progeria Syndrome (Progeria) is a rare autosomal disease that results in~     premature death at a median age of 13 years due to cardiovascular and cerebralvascular~     compromise. The mutation for this disease has been identified and results in a mutant form of~     lamin A that cannot be de-farnesylated. This study evaluates the combination of pravastain (a~     statin), lonafarnib (a farnesyltransferase inhibitor) and zoledronic acid (a bisphosphonate)~     in an open label phase II efficacy trial in children with Progeria. These agents all target~     farnesylation pathways at different points. Patients with genetically confirmed progeria will~     be eligible for this protocol. Treatment will be initiated for 24 months duration. Clinical~     and biologic parameters will be examined to assess response.~   "
202126|NCT00916734|"~     The purpose of this study is to determine whether patients who meet the criteria of the~     clinical prediction rule for spinal manipulation may respond more favorably to repeated~     exercises according to a direction of preference (what makes the symptoms decrease). The~     investigators do not know which of these two commonly-used treatments (manipulation or~     specific exercise) is better to treat low back pain.~   "
202127|NCT00916721|"~     Smoking is the leading cause of preventable morbidity and mortality in the US. While~     approximately 70% of smokers attempt to quit each year, only 5-15% maintain abstinence for 12~     months, even with effective pharmacological and psychological interventions. Novel therapies~     are needed for smoking cessation and relapse prevention. Previous studies show that early~     post-cessation craving or urge to smoke is a powerful predictor of relapse. A current model~     of the pathogenesis of addiction maintains that a substance of abuse causes a marked increase~     release in phasic dopamine release, which in turn strengthens or increases the salience of~     the memory of the drug experience, leading to a powerful and persistent memory that is easily~     activated, leading to drug craving and often to drug use. This highly salient memory is also~     implicated in the physiological arousal associated with craving responses to smoking cues.~     This process is thought to be implicated in relapse to drug use after even long periods of~     abstinence. Recent animal research indicates that retrieval returns a consolidated memory~     such as those associated with drug craving, to a labile state from which it must be~     restabilized to persist in a process termed reconsolidation. If memories of drug-related~     experiences are labile when reactivated, this could represent a window of opportunity in~     which the memory of drug use that underlies drug craving can be influenced pharmacologically.~     Our hypothesis is that post-reactivation administration of the B-adrenergic blocker,~     propranolol, following retrieval of drug-associated memories will reduce the strength or~     salience of the memory by influencing reconsolidation, a process called memory~     reconsolidation blockade. In this study we will test the hypothesis that a single dose of~     propranolol given one hour prior to smoking-related cue exposure (post-reactivation~     treatment) will decrease psychophysiological responses to smoking cues one week later and~     will predict clinical response to an ensuing series of 6 post-reactivation treatments with~     script-driven imagery and propranolol. In order to do so, we propose to conduct a randomized,~     double-blind, placebo-controlled trial of post-reactivation treatment with propranolol in 50~     adult smokers. Outcome measures will include in physiological responses to smoking-related~     cues after one and six post-reactivation treatments and smoking behavior during the treatment~     and during a 3-month follow-up period.~   "
202128|NCT00916708|"~     This study aims to compare two different follow up regimens with different test intensity in~     endometrial cancer treated patients.~      If eligibility criteria are satisfied and the written informed consensus is obtained,~     patients are stratified inside the centre according to their risk level:~        -  Group 1 : patients at low risk of recurrence [stage IA G1 and stage IA G2]~        -  Group 2 : patients at high-risk of recurrence [≥ stage IA G3] (Ethics Committee~          amendment of 14th September 2010, use new 2010 FIGO classification for endometrial~          cancer!)~      In each group patients will be randomized in two regimens of follow up:~        1. Minimalist (Arm 1)~        2. Intensive (Arm 2)~      Features of each arm are listed in Arms item.~   "
202129|NCT00916695|"~     The purpose of this study is to evaluate the efficacy and safety of the treatment of true~     bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel~     and provisional T-stenting in the side branch) compared to the complex strategy (stent in~     main vessel and T-stenting in the side branch).~   "
202130|NCT00916682|"~     This study seeks to provide point-of-care clinical diagnostic systems for the diagnosis of~     current disease status using saliva as a sample specimen.~   "
202131|NCT00916669|"~     The purpose of this research study is to see if adding enoxaparin sodium to standard~     treatment with the chemotherapy drugs cisplatin and etoposide will help treat extensive stage~     SCLC. Two different doses of enoxaparin sodium will be studied in order to determine if one~     dose is more effective than the other. Enoxaparin sodium (Lovenox) is a drug that is approved~     by the FDA to help treat or prevent blood clots. Results from previous research studies~     suggest that adding enoxaparin sodium to standard treatment improved the response to~     treatment for some study participants with various types of cancer.~   "
202132|NCT00916656|"~     This is a multinational, multicenter, prospective, open-label historically controlled Phase~     IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate~     (Human).~      It is estimated that 150-300 patients in the U.S. suffer from afibrinogenemia. Substitution~     with cryoprecipitate or alternative treatments have limited safety and efficacy.~      The primary purpose of the study is to demonstrate the hemostatic efficacy of Fibrinogen~     Concentrate (Human) by adequately controlling acute bleeding (spontaneous or after trauma) in~     patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia).~     Cryoprecipitate hemostatic efficacy data from a retrospective physician survey will be used~     as a historical control.~   "
202133|NCT00916643|"~     The objectives of this post-surveillance study are to continue to evaluate the safety and~     effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by~     evaluating the occurrence of death, cardiovascular events or interventions, angina, and~     serious unanticipated adverse effects. Laboratory assessments will be made to document~     low-density lipoprotein cholesterol (LDL-C) reduction and any effects on other blood~     components. Quality of life assessments will also be made.~      The study will also assess the modifications to the H.E.L.P. System, including:~        -  use of a single heparin adsorber, instead of two smaller adsorbers;~        -  change in the supplier of the ultrafilter (from Secon to Toray);~        -  reduction in the number of blood lines from eleven to nine;~        -  change from a single-layer to a two-layer precipitate filter.~      The safety and efficacy of the device specific to these modifications will be evaluated by~     comparing the safety and efficacy data from the patient registry to the data from the initial~     clinical study on the device as originally designed.~   "
202134|NCT00916630|"~     The purpose of this research study is to determine the safety of the study drug pemetrexed,~     and the highest dose of this drug that can be given to people safely. Another goal of this~     research study is to gain information about how the body handles pemetrexed and how~     pemetrexed may work to treat the participant's lymphoma in the nervous system. Pemetrexed~     (also known as Alimta) has been approved by the FDA for the treatment of some lung cancers~     and has been shown to be effective in laboratory studies. Information from these studies~     suggests that pemetrexed may help to treat patients with either primary or secondary central~     nervous system lymphoma.~   "
202135|NCT00916617|"~     This study will evaluate the safety and tolerability of bapineuzumab when administered by~     subcutaneous injection. The study is open only to subjects who participated in the preceding~     double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab~     for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will~     receive active treatment (bapineuzumab) and no subjects will receive placebo.~   "
202136|NCT00916604|"~     The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple~     repeated oral doses in Japanese patients with type 2 diabetes.~   "
202137|NCT00916591|"~     The purpose of this study is to compare the effect of two drugs that can help in the~     prevention of regurgitation during the administration of enteral nutrition and define which~     one is the most effective.~   "
202138|NCT00916578|"~     The goal of this clinical research study is to find out if Xeloda® (capecitabine) and~     radiation therapy can help to control breast cancer that did not respond well to~     chemotherapy.~      The safety of this study treatment will also be studied.~   "
202139|NCT00916565|"~     The purpose of this study is to look at the function of infant formula components to optimize~     the nutritional content and functionality of a marketed routine infant formula.~   "
202140|NCT00916552|"~     Depression and bipolar disorder (mania and depression) may be related to problems with nerve~     cells not being regenerated as fast as normal and are accompanied by cognitive difficulties~     including memory, attention and planning problems. There is thus a need for better, more~     efficient treatments with effects on cognitive function. Erythropoietin (Epo) is involved in~     brain repair and may be a candidate for future treatment strategies. The investigators have~     demonstrated that a single dose of Epo improves mood and reduces the processing of negative~     emotional information in healthy volunteers similar to effects seen with antidepressants.~     With the current study the investigators aim to build upon this discovery by investigating~     whether repeated Epo administration has antidepressant effects and is able to reverse~     cognitive difficulties in patients with depression or bipolar disorder. It is hypothesized~     that Epo will improve mood in treatment-resistant depression and improve cognitive function~     in this group and in patients with bipolar disorder in remission. If the study reveals~     beneficial effects of Epo, this would highlight Epo as a candidate compound for future~     treatment of depression and bipolar disorder, with the potential to directly promote brain~     repair mechanisms.~   "
202141|NCT00916539|"~     This trial is trying to understand if immobilization of the thumb after a non-displaced~     scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for~     free movement of the thumb, and in the United States it is a cast that immobilizes the thumb.~     This study is attempting to understand if there is a difference.~   "
202142|NCT00916526|"~     Chronic cough is defined by its persistence beyond 8 weeks. Many conditions can explain the~     existence of a bronchial inflammation. In the management of chronic cough, the search for~     bronchial hyperreactivity (HRB) is recommended. The treatment relies primarily on the~     prescription of inhaled corticosteroids. It has been shown recently that the existence of an~     HRB with Methacholine (bronchial provocation test used in routine) does predict the~     effectiveness of inhaled corticosteroid treatment in no more than 50% of cases.~      It is now possible to assess the bronchial inflammation by rapid, non-invasive and~     reproducible tests such that the fraction of exhaled nitric oxide (FeNO) and bronchial~     provocation test with mannitol. In a retrospective study, it was shown that an increased~     value of FeNO (cut-off > 35 ppb) predicts a positive response to treatment with a sensitivity~     of 90% and a specificity of 80%.~   "
202143|NCT00916513|"~     The present European survey seeks to assess quality of life and satisfaction with treatment~     in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia~     and level of glycaemic control. It will also provide relevant information on other important~     aspects such as the level of correlation of objective measures such as HbA1c with health~     status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients~     will be invited to participate from a representative sample of clinical practices during a~     pre-specified period. The study will entail a single patient visit. Patients who agree to the~     study and give their informed consent will complete questionnaires which, combined with~     retrospective notes review & an HbA1c test, will allow patient, disease and treatment~     variables to be collected. An HbA1c test is a finger prick test to measure glycosylated~     haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.~   "
202144|NCT00916500|"~     Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical~     cancer.~      However, the most effective chemotherapy regimen is controversial. Weekly cisplatin,~     hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials.~      Weekly cisplatin needs frequent hospital visits and had a poor compliance profile in korea.~      Combination chemotherapy regimens had more adverse effects than weekly cisplatin without~     improving outcomes.~      We conducted a retrospective analysis comparing weekly cisplatin with cisplatin every 3 weeks~     and observed favorable outcome for cisplatin every 3 weeks regimen (still not published).~      Therefore, we designed a phase 2 trial evaluating the efficacy and feasibility of CCRT with~     cisplatin every 3 weeks.~   "
202145|NCT00916487|"~     The purpose of this study is to determine whether the enzymatic product Frucosin(R) is able~     to degrade fructose in vivo in the small intestine of patients with known fructose~     malabsorption by measuring hydrogen in the expiratory air.~   "
202146|NCT00916474|"~     Observational follow-up study to assess long-term response to telaprevir and to evaluate~     changes in Hepatitis C virus over time.~   "
202147|NCT00916461|"~     The purpose of this study is to determine whether the addition of minocycline or placebo to~     treatment as usual (TAU):~        1. prevents the accumulation of negative symptoms and intellectual decline following a~          first episode of non-affective psychosis; and~        2. whether minocycline stabilizes the efficacy of antipsychotics.~   "
202171|NCT00916149|"~     The purpose of this study is to determine if levetiracetam (for patients with focal seizures)~     or lamotrigine (for patients with generalized seizures) reduces the occurrence of interictal~     discharges. The study investigates the possible correlation between reduction of interictal~     discharges and improved cognitive performance.~   "
202172|NCT00916136|"~     The purpose of this study is to determine whether there are any differences in skeletal or~     cutaneous traction for the treatment of femur fractures.~   "
202148|NCT00916448|"~     Excessive inflammation, production of free radicals and vascular injury are considered the~     main contributors to the development of organ dysfunction in patients with severe infections~     and sepsis. The endogenously produced unconjugated bilirubin is one of the most powerful~     anti-oxidants of the human body and the administration of bilirubin in animal experiments has~     been shown to protect from inflammation-induced death. However, bilirubin for human~     administration is not yet available. Therefore, we wish to exploit one of the side effects of~     atazanavir, a registered drug currently used as a protease inhibitor in HIV infected~     patients. Atazanavir inhibits the enzyme UPD glucuronosyl transferase enzyme (UGT1A1) and~     therefore increases endogenously produced bilirubin levels moderately. To study the effect of~     hyperbilirubinemia during inflammation we will apply the human endotoxemia model. The human~     endotoxemia model permits elucidation of key players in the immune response to a gram~     negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel~     therapeutic strategies in a standardized setting. We hypothesize that atazanavir-induced~     hyperbilirubinemia has beneficial anti-inflammatory and vascular effects during human~     endotoxemia.~   "
202149|NCT00916435|"~     The purpose of this study is to determine whether waveforms of the intracardiac electrograms,~     acquired through an ICD, can be used:~        -  to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and~        -  to predict progression of heart failure in patients with ICD.~   "
202150|NCT00916422|"~     The objective of this trial is to assess the clinical efficacy of the modified extract~     (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum~     pratense pollen in the treatment of patients affected by allergic rhinitis/~     rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass~     pollen, evaluating the Score regarding Symptoms and consumption of the medication.~   "
202151|NCT00916409|"~     The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy~     and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care~     in the treatment of newly diagnosed GBM patients. The device is an experimental, portable,~     battery operated device for chronic administration of alternating electric fields (termed~     TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated~     electrode arrays.~   "
202152|NCT00916396|"~     Hypoactive Sexual Desire Disorder (HSDD) is a common syndrome characterized by low sexual~     desire causing marked distress. The involvement of DHEA in sexual function is unknown,~     however, DHEA treatment increased desire in depressed subjects. In the current research, we~     will treat 45 women and men suffering from low sexual desire with DHEA or placebo for 6~     weeks. The study's primary goal is to determine the effect of DHEA treatment on sexual~     desire, and to find if there is a connection between levels of hormones and change in desire.~     Outcome measures will include hormonal levels and psychological state. Our secondary goal is~     to compare baseline hormones measures in individuals with low sexual desire to normal~     controls. For that purpose we will measure the hormonal baseline levels among 20 normal~     subjects.~   "
202153|NCT00916383|"~     This study is designed to assess skin tolerability, skin irritation, and adhesion of the 350~     mg Donepezil Transdermal Patch (DTP-system), following 3, 7-day applications to 3 specific~     areas of the body (upper back, upper middle arm, side of torso) of elderly Alzheimer's~     patients. The total application time for the DTP-system is 21 days.~   "
202154|NCT00916370|"~     To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion~     (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter~     in subjects with symptomatic heart disease due to a maximum of two de novo native coronary~     artery lesions, each in a different epicardial vessel.~   "
202155|NCT00916357|"~     This is a single-center, Phase 2, randomized, double-blind, 3-way crossover meal study in~     participants with Type 2 Diabetes Mellitus (T2DM) to determine the optimum dose and compare~     the pharmacokinetics (PK) and postprandial glycemic response of Humalog alone, Humalog +~     recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 administered~     subcutaneously.~   "
202156|NCT00916344|"~     The objective of this study is to prove the safety and efficacy of the EVIA pacemaker.~     Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which~     automatically measures the right atrial threshold and subsequently adjusts the pacing output.~   "
202157|NCT00916331|"~     This prospective, randomized trial asked whether subcutaneous indwelling of vacuum drainage~     has advantages over intraarticular indwelling in terms of blood loss, bleeding related~     complications, and functional outcomes in primary total knee arthroplasty (TKA). The~     investigators hypothesized that the subcutaneous indwelling method would reduce blood loss~     with comparable bleeding-related complications and functional outcomes. The subcutaneous~     indwelling group demonstrated reduced blood loss with comparable prevalence of~     bleeding-related complications and functional outcomes. In conclusion, the investigators'~     study verified the efficacy and absence of risks of subcutaneous indwelling method. So the~     investigators propose that the subcutaneous indwelling drainage can be a good option to~     address the problems related to postoperative bleeding after TKA.~   "
202158|NCT00916318|"~     To evaluate the effects of a family-based intervention program intended for parents of~     pre-school children (4-6 y) with overweight and obesity (according to Cole et al), and to~     investigate if treatment has an effect on metabolic parameters. In a randomised controlled~     trial evaluate the three separate family based intervention programs and to investigate if~     treatment has an effect by correlating the parameters described above with BMI, before and~     after the intervention program.~   "
202173|NCT00916123|"~     The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591~     antibody in combination with docetaxel chemotherapy against metastatic, castrate-resistant~     prostate cancer.~   "
202174|NCT00916110|"~     To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in~     healthy Japanese male subjects.~   "
202175|NCT00916097|"~     Primary Objective:~      To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2~     in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional~     radiotherapy in UCNT.~      Secondary Objectives:~      To evaluate:~        -  The radiological response after chemotherapy and radiotherapy~        -  The pathological response after chemotherapy by cavum biopsy~      To estimate:~        -  The duration of overall response~        -  The time to progression (T.T.P)~      To analyze:~        -  The overall survival~        -  The safety profile~   "
202159|NCT00916305|"~     In 1986 The Medical Research Council estimated that 4 million UK adolescents were at risk of~     hearing damage from over-exposure to loud music from personal audio players (PAPs), gigs,~     clubs, pubs and festivals. Since that time social noise exposure is estimated to have tripled~     to 19% of young people. The European Commission commissioned a report that estimated 5-10% of~     personal audio player users are risking permanent hearing loss and tinnitus by listening to~     music at high volumes for more than 1 hour a day for 5 years or more. Up to 246 million PAPs~     were sold in Europe in 2008, and 200 million mobile phones, many of which now have built-in~     audio players. Nevertheless, a recent survey showed that only 8% of young people identify~     hearing loss as a health problem. The Royal National Institute for the Deaf (RNID) undertook~     two surveys of young people in the UK to analyse listening behaviours as part of their Don't~     Lose the Music campaign. As a consequence they offer listening advice given by flyers at~     events and online at the dedicated website. There have been no studies to confirm if such~     advice is effective in reducing noise exposure.~      Aim: This study will pilot a methodology for a randomised controlled trial to test the~     effectiveness of a publically-available online video in changing the listening habits of~     young music lovers i.e. reduce the volume and number of hours of exposure.~      Hypothesis: A video and adapted sound track demonstrating the experience of noise-induced~     hearing loss and tinnitus accessed online will change the listening habits of 18-25~     year-olds.~   "
202160|NCT00916292|"~     The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of~     a wound.~   "
202161|NCT00916279|"~     The study will enroll patients with angiographic evidence of in-stent restenosis of a~     previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The~     purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in~     the native coronary system. Angiographic and clinical outcomes will be assessed.~   "
202162|NCT00916266|"~     This research investigates the use of autologous bone marrow stem cells for the treatment of~     medically refractory temporal lobe epilepsy patients.~   "
202163|NCT00916253|"~     The project will improve scientific knowledge regarding a recent law applying potentially to~     every french driver. It will give for the first time an indication on the impact of alerting~     treatments on driving risks. It will reinforce the links between different research~     environments (sleep physiopathology, clinical research, cognitive neurosciences, driver's~     supervision, virtual reality, pharmacology) among the RESAT network (Réseau Eveil Sommeil~     Attention Transport). It will stimulate data acquisition in technological research to better~     understand the difference between real and simulated driving~   "
202164|NCT00916240|"~     Asthma is a chronic lung disease that inflames and narrows the airways. Symptoms can include~     recurring periods of wheezing, chest tightness, shortness of breath, and coughing. Minority,~     inner city teens are at increased risk for complications from the disease, possibly because~     of poor illness management. The purpose of this study is to test the effectiveness of~     Multisystemic Therapy (MST)—an intensive, home- and community-based psychotherapy—for~     improving asthma management and overall health and for reducing healthcare costs for inner~     city African American teens with asthma.~   "
202165|NCT00916227|"~     This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic~     syndrome (MDS) will receive investigational study drug ARRY-614.~      This study has 2 parts. In the first part, patients will receive increasing doses of study~     drug, given either with food or without food, in order to achieve the highest dose of the~     study drug possible that will not cause unacceptable side effects. Approximately 60 patients~     from the US will be enrolled in Part 1 (Completed).~      In the second part of this study, patients will receive the best dose of study drug, given~     either with food or without food, determined from the first part of the study and will be~     followed to see what side effects and effectiveness the study drug has, if any, in treating~     the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).~   "
202166|NCT00916214|"~     The aim of the project is to evaluate effectiveness of a multidimensional pharmaceutical care~     plan in improving compliance among elderly polypharmacy users at community pharmacy settings.~     The specific objective of the project is to determine effects of pharmaceutical care program~     on medication adherence and persistence among elderly polypharmacy users.~   "
202167|NCT00916201|"~     Different compounds that might modify the glucose regulation in the central nervous system~     will be evaluated in healthy volunteers. Several examinations will be performed in order to~     get a detailed plan how these substances might work.~   "
202168|NCT00916188|"~     The primary objective of this study is to evaluate the efficacy of different doses of black~     tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in~     improving oxidative stress, lipid profiles and insulin sensitivity.~   "
202169|NCT00916175|"~     High blood sugar and adiposity are part of Metabolic syndrome (about 24% of adults harbor~     it). The main approach, weight reduction, is often unattainable. Aloe Vera (barbadensis) (AV)~     and cnidoscolus chayamansa (McVaugh)(CC) are two vegetables that seem to have an effect on~     blood glucose and body weight.~      The study aims to determine if the intake of aloe gel and/or Chaya infusion can reduce high~     blood sugar in adult women with pre-diabetes (Metabolic Syndrome).~      Methods: A Factorial assay, double blind, cross-over-controlled with random assignment, to~     four treatments: AV and CC, AV and Placebo 1, Placebo 2 and CC, and Placebo 1 and Placebo 2,~     at the outpatient clinic of the university Hospital and a community clinic.~      Two treatment periods of 4 weeks intermediated by one week for wash-out.~   "
202170|NCT00916162|"~     The purpose of this research study is to study the effects of stopping aromatase inhibitory~     (AI) therapy on breast cancer progression. Aromatase inhibitors are a class of drugs used to~     treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen,~     which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses~     despite therapy with an AI is thought to have been resistant to AI therapy. There is~     scientific evidence to suggest that resistant breast cancer cells learn to grow at the very~     low levels of estrogen present on AI therapy and that increasing estrogen levels even~     slightly by stopping AI therapy with inhibit the breast cancer cells. An improvement or~     stabilization of breast cancer has been observed after stopping therapy with tamoxifen, a~     different anti-estrogen therapy, and has been reported in the literature after stopping AI~     therapy. This research study will be the first study to formally test the rate of disease~     improvement (response) or stabilization after stopping AI therapy.~   "
202177|NCT00916071|"~     To understand whether a relationship exists between eating disorders and ADHD, we seek to~     clarify the prevalence of ADHD in individuals with eating disorders. To this end, we will~     estimate the prevalence of ADHD, and other neuropsychiatric disorders, in outpatients with~     history of an eating disorder diagnosis. Secondarily, we will identify patterns of cognitive~     deficits in outpatients with history of an eating disorder diagnosis. We will also examine~     whether ADHD in this population is associated with functional and familial correlates~     associated with ADHD.~   "
202178|NCT00916058|"~     The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™),~     in combination with Melphalan in subjects with multiple myeloma who are undergoing an~     Autologous Stem Cell Transplant.~   "
202179|NCT00916045|"~     The purpose of this study is to determine the safety and feasibility of unrelated double and~     single cord blood transplantation in patients with haematological malignancies using~     reduced-intensity or myeloablative conditioning regimens.~   "
202180|NCT00916032|"~     The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU~     Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate~     using two vials of 1500 IU potency dissolved in 5 mL diluent each (administered in 10 mL~     diluent in total) in previously treated patients with severe hemophilia A (factor VIII level~     < 1%).~   "
202181|NCT00916019|"~     The investigators have previously shown that mild exercise training at the level of lactate~     threshold (LT) intensity (60 min/day, 5 days/week) improves peripheral insulin sensitivity~     and insulin-independent glucose disposal of glucose effectiveness, without changes in body~     weight and body fat (Nishida et al, Diabetes Care, 2001; Nishida et al, Diabetes, 2004). Thus~     these beneficial effects are likely related to a number of adaptations that occur in skeletal~     muscle as response to exercise. In the current study, the investigators hypothesised that a~     single bout of mild exercise performed at LT would be a physiological stimulator of skeletal~     muscle PGC-1alpha gene, and the repetition of this exercise stimulating PGC-1alpha gene~     (i.e., training) for 12 weeks would induce coordinated increases in a large number of~     metabolic genes, as well as other genes potentially important in the prevention of insulin~     resistance and metabolic syndrome.~   "
202182|NCT00916006|"~     This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when~     applied to an area of skin containing 4-8 AK lesions on the face or scalp.~   "
202183|NCT00915993|"~     RATIONALE: Diagnostic procedures, such as MRI, may help doctors predict a patient's response~     to treatment and help plan the best treatment.~      PURPOSE: This clinical trial is studying MRI in predicting response to sunitinib malate in~     patients with stage IV kidney cancer.~   "
202184|NCT00915980|"~     In many studies, gastric bypass surgery led to total remission of type 2 diabetes (T2DM) as~     early as 1 - 2 days after surgery before any real weight loss has occurred. This suggests~     that the remission of the T2DM is due to the direct effect of the operation, more than the~     secondary effect of the weight loss. The reasons for the major effect on the glucose~     metabolism after gastric bypass surgery are still unaccounted for.~      The aim of this project will be to unveil some of the mechanisms that explain the effect of~     gastric bypass surgery on the glucose metabolism. Further more to find a better way of~     testing patients that have just undergone gastric bypass surgery. It is not possible to test~     patients who have just undergone gastric bypass surgery with normal oral glucose tolerance~     test (OGTT) and a normal meal, because patients can only take in fluid and a normal OGTT will~     often lead to dumping. Instead we will try to modify these tests - OGTT with lower glucose~     level and meal-testing with a protein drink.~      The hypothesis of the study is that the investigators can see changes in different hormones~     and adipokines before and after surgery, even with modified OGTT and meal testing. The~     project will consist of clinical trials on patients without T2DM that will undergo gastric~     bypass surgery. The studies will take place before and within the first week after surgery.~     The investigators will measure different hormones and adipokines after OGTT and a meal with a~     protein drink. The investigators expect to see significant changes in some of the analyses~     after the operation in patients undergoing gastric bypass.~   "
202185|NCT00915967|"~     The goal of this study is to determine whether injecting the antibiotic vancomycin directly~     into surgical wounds can decrease the rate of infection following implantation of~     neurosurgical devices.~   "
202186|NCT00915954|"~     Growth hormone (GH) and Insulin-like growth factor-I (IGF-I) secretion are altered in~     acromegaly and type 2 Diabetes Mellitis (DM). The secretion of GH is mediated by central~     hypothalamic hormones (GH Releasing Hormone and somatostatin) as well as peripheral factors~     providing feedback inhibition (IGF-I and glucose, among others). The purpose of this study is~     to compare growth hormone suppression after an oral glucose tolerance test (OGTT) to growth~     hormone suppression after recombinant human IGF-I (rhIGF-I) administration. This study will~     recruit participants with active acromegaly, type 2 diabetes mellitus, and healthy control~     subjects. Each participant will undergo a screening evaluation, and three subsequent visits.~     Each participant will receive a placebo subcutaneous injection, OGTT, and administration of~     rhIGF-I, on separate visit days. Glucose, insulin, GH, bioactive IGF-I and IGF-I binding~     proteins will be measured after each intervention. Results will be compared between the three~     groups. It is predicted that the administration of rhIGF-I will demonstrate GH suppression in~     all healthy subjects and subjects with type 2DM. Some acromegaly subjects may demonstrate GH~     suppression in response to IGF-I administration, but not to the degree seen in healthy~     subjects or type 2 DM. OGTT will demonstrate suppression of GH in normal subjects, and will~     show attenuated suppression in type 2 DM and a failure of suppression in acromegaly.~   "
202187|NCT00915941|"~     The purpose of this study is to learn if chemicals from the mouth or stomach can be found in~     the lungs. This may suggest a process called aspiration. This study may help us understand if~     aspiration plays a role in different lung diseases.~   "
202188|NCT00915928|"~     The project aims at investigating if treatment with the Angiotensin Converting Enzyme~     inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma~     will decrease the risc of recurrence.~   "
202189|NCT00915915|"~     Investigation of two transdermal hormone patch formulations for contraception regarding~     inhibition of ovulation over a period of 3 treatment cycles in healthy young female~     volunteers~   "
204538|NCT00884377|"~     This study serves to compare the effectiveness of treating cutaneous leishmaniasis with~     either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM~     device.~   "
202190|NCT00915902|"~     High triglyceride levels are increasingly recognized in children, particularly those who are~     overweight. There are no studies of treatment of high triglycerides in children and~     adolescents. Fish oil is attractive because it is considered safe and effective for treating~     high triglycerides in adults and has been used safely for other purposes in children. The~     investigators will conduct a randomized study of Lovaza (the only prescription omega-3 fish~     oil medication) in 44 children and adolescents to study efficacy in lowering triglycerides,~     safety, and possible mechanisms of beneficial effects.~   "
202191|NCT00915889|"~     RATIONALE: Telephone counseling may help reduce depression and anxiety and improve the~     well-being and quality of life of cervical cancer survivors.~      PURPOSE: This randomized clinical trial is studying how well psychosocial support works in~     African-American, Latina-American, or European-American cervical cancer survivors.~   "
202192|NCT00915876|"~     This research is studying how Vitamin D may affect blood vessels reaction to stress and blood~     levels of substances that may increase blockages in the blood vessels in chronic kidney~     disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown~     that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study~     (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid~     hormone levels. The purpose of this study is to find out if paricalcitol has other benefits~     beyond its ability to lower parathyroid hormone levels such as improving the blood vessels~     reaction to stress and decreasing blood levels of substances that may increase blockages in~     the blood vessels.~   "
202193|NCT00915863|"~     The purpose of this study is to evaluate the incidence of complications with the isolated~     Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary~     tumor patients. A prospective randomized controlled trial was conducted to compare the~     incidence of complications with isolated Roux-en-Y reconstruction with those of~     Billroth-II-type reconstruction after pancreaticoduodenectomy.~   "
202194|NCT00915850|"~     This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD),~     dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel,~     cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness~     of the this regimen is evaluated by RECIST, time to progression and median survival time.~   "
202195|NCT00915837|"~     This Phase 1 study will evaluate the safety, tolerability and duration of effect of a helical~     intravitreal triamcinolone implant for the treatment of diabetic macular edema over a~     three-year period.~   "
202196|NCT00915824|"~     Potentially inappropriate prescribing is common in older patients and encompasses overuse,~     misuse and underuse of medications. Potentially inappropriate prescribing is associated with~     negative outcomes including adverse drug events and hospitalization.~      STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) and START~     (Screening Tool to Alert doctors to Right Treatment) is a new screening tool designed to~     detect instances of potentially inappropriate medication use and under-prescribing of~     clinically indicated medications in older patients. The purpose of this study is to determine~     whether clinical implementation of STOPP/START criteria in hospitalized older patients is~     effective in improving prescribing quality.~   "
202197|NCT00915811|"~     The purpose of this study is to determine the safety and feasibility of conditioning with~     fludarabine, busulphan and thymoglobuline in patients with myelodysplastic syndrome (MDS),~     myelodysplastic/myeloproliferative disorders (MDS/MPD) or acute myeloid leukaemia (AML)~     undergoing haematopoietic stem cell allograft with granulocyte colony-stimulating factor~     (G-CSF)-mobilised peripheral blood stem cells (PBSC) (or bone marrow) from HLA compatible~     sibling donors.~   "
202198|NCT00915798|"~     The study investigated the underlying mechanisms of smoking in young adults by examining the~     associations between smoking, brain activity, dopamine genes, and attention deficit~     hyperactivity disorder (ADHD).~   "
202199|NCT00915785|"~     The purpose of this study is to assess the hematological and cytogenetic responses with 5~     azacytidine in patients over 55 years of age with MDS/AML due to chromosome 7 abnormalities~     and to assess the hematological and cytogenetic response rates in patients with relapsed AML~     and chromosome 7 abnormality.~   "
202200|NCT00915772|"~     A phase III randomised, double-blind parallel group extension study to investigate the~     efficacy and safety of twice daily administration of the free combination of linagliptin 2.5~     mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with~     metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing~     the double-blind part of study 1218.46~   "
202201|NCT00915759|"~     The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after~     photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects,~     visual recovery, refractive accuracy, and corneal clarity.~   "
202202|NCT00915746|"~     This is an open-label (both the physician and healthy volunteer know which treatment will be~     administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is~     absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken~     alone and in combination with ketoconazole. The study consists of three phases: a screening~     phase to determine eligibility, an open-label treatment phase consisting of three periods and~     an end-of study/early withdrawal assessment phase.~   "
202218|NCT00915538|"~     This study will compare the amount of bronchial tube relaxation from the formoterol medicine~     contained in the symbicort pMeterd Dose Inhaler( a combination of budesonide ,a steroid, and~     formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using~     the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing~     in the medication. Breathing tests will be measured over a 12 hour period for the comparison.~   "
202219|NCT00915525|"~     The purpose of this study is to assess the long term safety and effectiveness of botulinum~     toxin type A in treating patients with idiopathic overactive bladder with urinary~     incontinence.~   "
202220|NCT00915512|"~     The purpose of this study is to evaluate the response to treatment and safety of paliperidone~     extended-release (mechanism to dissolve a drug over time in order to be released slower and~     steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with~     symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self).~   "
202203|NCT00915733|"~     Percutaneous coronary intervention (PCI) with stent implantation is the preferred reperfusion~     strategy for treatment of acute myocardial infarction (AMI). Despite advances in both devices~     and pharmacological support for AMI patients undergoing PCI, the risk of recurrent ischemic~     events has been higher than that of elective PCI. Among therapeutic options for surmounting~     clopidogrel hyporesponsiveness, higher loading doses and maintenance doses of clopidogrel~     achieved significant enhancements in the speed of onset and intensity of inhibition and these~     approaches have been widely adapted in clinical practice. Interestingly, recent studies found~     that carriers of the loss-of-function hepatic cytochrome (CYP) 2C19 allele had significantly~     lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a~     higher rate of major adverse cardiovascular events than did non-carriers, in the setting of~     PCI and acute coronary syndrome (ACS). These findings raise the need of solutions to overcome~     enhanced post-clopidogrel platelet reactivity by the influence of the loss-of-function~     CYP2C19 allele. Increasing the dose of clopidogrel, new potent P2Y12 antagonists (such as~     prasugrel), or other antiplatelet drugs such as cilostazol may be alternative antiplatelet~     regimens in patients with the loss-of-function CYP variant. A recent study demonstrated that~     adjunctive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) intensified~     platelet inhibition as compared with a high maintenance-dose (MD) of 150 mg/day. Therefore,~     triple antiplatelet therapy could also be an alternative antiplatelet therapy to improve~     platelet inhibition and clinical outcomes in carriers of CYP2C19 mutant allele.~      The purpose of this study was to determine the impact of adjunctive cilostazol on platelet~     inhibition in carriers and non-carriers of the loss-of-function CYP2C19 allele. The~     investigators compared the enhanced inhibition of platelet aggregation by adjunctive~     cilostazol 100 mg twice daily versus high-MD clopidogrel 150 mg/day in AMI patients treated~     with emergent coronary stenting, according to the CYP2C19 polymorphism.~   "
202204|NCT00915720|"~     This is a pilot study to determine if implanted loop recorders can more effectively monitor~     atrial fibrillation recurrence after atrial fibrillation ablation.~   "
202205|NCT00915707|"~     This study is designed to study the pathways through which short sleep duration or poor sleep~     quality can lead to an increased risk of developing diabetes and obesity.~   "
202206|NCT00915694|"~     RATIONALE: Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor~     cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     nelfinavir mesylate together with radiation therapy and temozolomide may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate~     when given together with radiation therapy and temozolomide in treating patients with~     glioblastoma multiforme.~   "
202207|NCT00915681|"~     Legalon® SIL will be administered to patients with amatoxin poisoning diagnosed by history,~     gastrointestinal symptoms, elevated liver enzymes, and/or diagnostic assay (should one become~     available). Patients may or may not also demonstrate abnormalities in bilirubin and/or~     creatinine. Treatment consists of a 5 mg/kg loading dose followed by 20 mg/kg/day via~     continuous infusion. The treating physician is expected to administer supportive therapy of~     his/her choosing but consistent with best practices. Legalon® SIL will be stopped when~     coagulopathy is no longer present, and when liver function tests have returned significantly~     towards the normal range. Patients will be followed 7-14 days after the end of Legalon® SIL~     therapy with follow up lab studies.~   "
202208|NCT00915668|"~     The main purpose of this research study is to evaluate the effect of multiple doses of an~     investigational drug known as JNJ-31001074 on the single dose of combination oral~     contraceptive Ovral-L containing ethinyl estradiol and levonorgestrel in healthy women who~     cannot bear children. This study will look at the safety, tolerability (how the drug makes~     you feel) and pharmacokinetics (what your body does to the drug) of either drug alone and in~     combination in healthy women.~   "
202209|NCT00915655|"~     The purpose of this study is to evaluate pharmacokinetics (what body does to medication),~     safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir~     (DRV/rtv) administered once daily, in combination with an investigator-selected background~     regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse~     transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected~     adolescents aged from 12 to <18 years and weighing at least 40 kg.~   "
202210|NCT00915642|"~     The objectives of the present study are:~        1. to evaluate if overnight weight loss is dependent on sleep structure assessed by~          polysomnography;~        2. to compare weight loss rate during sleep and awake rest;~        3. to compare night weight loss profile of normal and obese volunteers.~   "
202211|NCT00915629|"~     Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with~     considerable morbidity and health-care cost. 75% of women will suffer of Candida infection~     for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes~     of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida~     albicans. Current treatments, based on imidazoles, face many failures or recurrences. The~     type of probiotic Lactobacillus may participate in the prevention of recurrent~     vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence~     to the vaginal walls, the potentiation of its propagation. The primary objective of this~     study was to investigate if our supplementary treatment could improve the initial cure rate~     after vaginal econazole therapy.~   "
202212|NCT00915616|"~     Gastro-Esophageal Reflux Disease was defined as a condition that develops when the reflux of~     stomach contents causes troublesome symptoms and/or complications. Many drugs used for the~     treatment of GERD such as omeprazole (a proton pump inhibitor) which is widely used~     anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury.~     Melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused~     by reactive oxygen species in different experimental ulcer models. The aim of this study is~     to evaluate the role of exogenous melatonin in the treatment of reflux disease in human~     either alone and in combination with omeprazole therapy.~   "
202213|NCT00915603|"~     This randomized, double blind, placebo controlled trial will evaluate the impact of adding~     everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line~     treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized~     (1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/~     bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment~     every 8 weeks; responding and/or stable patients will continue treatment, with re-evaluations~     every 8 weeks, until tumor progression or~      intolerable toxicity occurs. Outcomes will be assessed for each treatment arm~      separately. This trial is not intended to compare treatment arms primarily. Any such analyses~     are exploratory and will be conducted without adjustment for multiple hypothesis testing.~   "
202214|NCT00915590|"~     The purpose of this study is to determine the effectiveness and safety of~     Interleukin-1-Receptor Antagonist eye drops for the treatment of corneal blood vessels.~   "
202222|NCT00915486|"~     Although major improvements in the management and treatment of diabetic foot ulcers have been~     made, the clinical and financial burden of such long-term wounds is still high and is likely~     to increase as the general population ages. The large population affected by diabetic foot~     ulcers and the high rates of failure ending with amputation even with the best therapeutic~     regimens have resulted in the development of new therapies. I-020201 is a bioactive therapy~     intended for topical treatment of hard-to-heal diabetic foot ulcers, stimulating the~     granulation tissue formation. This study aims to evaluate the safety and efficacy of I-020201~     in adjunct to good standard of care in patients with chronic diabetic foot ulcer.~   "
202223|NCT00915473|"~     Migraine is a common neurological condition that can be disabling, particularly if chronic.~     Greater occipital nerve (GON) block has been utilized for decades for the treatment of~     migraine in the absence of a single randomized, placebo-controlled trial documenting its~     effectiveness.~      Hypothesis: Greater occipital nerve block reduces the frequency of days with moderate or~     severe headache in patients with episodic or chronic migraine.~   "
202224|NCT00915460|"~     To collect data on serious adverse events which occur during extended treatment with Avonex~     in subjects at high risk for developing multiple sclerosis (MS) and in subjects with~     secondary progressive MS.~   "
202225|NCT00915447|"~     The purpose of this study is to measure the effects of allergens and/or diesel exhaust~     particles in the nose to learn more about allergic responses in individuals with cat allergic~     rhinitis.~   "
202226|NCT00915434|"~     This is an open-label (both the physician and healthy volunteer know which treatment will be~     administered), single-dose, 4-period study to characterize the pharmacokinetics (process by~     which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) and~     effect of food on the pharmacokinetics of JNJ-31001074. The study consists of three phases: a~     screening phase to determine eligibility, an open-label 4-period treatment phase and an~     end-of-study/early withdrawal assessment phase.~   "
202227|NCT00915421|"~     Type of study: Pilot prospective nonrandomized feasibility clinical study.~      Aim of the study: To assess the feasibility of pre-hospital therapeutic mild hypothermia in~     patients successfully resuscitated from out-of-hospital cardiac arrest in the setting of~     prehospital and hospital care in Czech republic.~      Evaluated hypothesis: Pre-hospital initiation of therapeutic mild hypothermia by rapid~     administration of intravenous bolus of cold crystalloids is simple, safe, effective and is a~     feasible procedure to significantly decrease body core temperature during patient's transport~     to the hospital in Czech republic.~      The study is observational and does not evaluate any new drug, therapeutic procedure or~     diagnostic procedure. It is evaluating a known therapeutic procedure, therapeutic mild~     hypothermia, induced by known technique, cold crystalloid infusion, widely accepted in~     hospital-related postresuscitative care. However, even its prehospital usage has been~     published.~   "
202228|NCT00915408|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and to evaluate~     the safety of cyclophosphamide when given on days 1 and 8 in a 28 day cycle in doses starting~     at 300mg ranging to 700mg in combination with Lenalidomide (Revlimid®) plus dexamethasone in~     patients who present with relapsed or refractory myeloma.~   "
202229|NCT00915382|"~     The urgent need for a new effective therapy with better safety profile for the metastatic~     gastric cancer patients and promising results observed so far in the studies with S-1 plus~     cisplatin combination in advanced gastric cancer (AGC) strongly warrants the comparison of a~     3-weekly schedule to a 5-weekly schedule of S-1 plus cisplatin as a standard regimen in the~     first-line treatment for AGC patients.~      The objectives of this study are to compare a 3-weekly schedule to a 5-weekly schedule of S-1~     plus Cisplatin combination in terms of efficacy, quality of life and safety in patients with~     previously untreated advanced or recurrent unresectable gastric cancer. Primary endpoint is~     progression-free survival. This is an open label, randomized, multi-center,~     non-inferiority/superiority (of 3-weekly regimen over 3-weekly regimen) hybrid study.~   "
202230|NCT00915369|"~     This study is a multicentre, open label, non-randomized phase I study. The main objectives of~     the study are to determine the pharmacokinetic profile of the drug at different dose levels~     in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of~     Paclitaxel Nanoparticle will also be simultaneously assessed.~   "
202231|NCT00915356|"~     This study is being carried out to see which dose of AZD1305 is safe and effective in~     cardioverting atrial fibrillation into normal heart rhythm.~   "
202232|NCT00915343|"~     This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase~     II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral~     modified-release hydrocortisone in comparison to conventional thrice-daily oral~     hydrocortisone tablets in patients with adrenal insufficiency~   "
202233|NCT00915330|"~     The purpose of this study is to determine whether rapid on-site cytopathologic evaluation~     (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the~     diagnosis of hilar and mediastinal lymphadenopathy.~   "
202234|NCT00915317|"~     While vitamin D supplementation is safe and effective in repleting vitamin D levels in~     dialysis patients, the impact on anemia is unknown. The majority of hemodialysis patients~     require erythropoietin supplementation to maintain their serum hemoglobin between 11 and 12~     gm/dL, a drug that is both costly and associated with significant side effects. If repletion~     of vitamin D significantly decreases erythropoietin requirements in hemodialysis patients, it~     would result in a substantial reduction in patient care costs. Our aim is to study the impact~     of ergocalciferol supplementation in hemodialysis patients with 25-hydroxyvitamin D~     deficiency. The investigators anticipate approximately 30% reduction in erythropoietin dose~     requirement in our hemodialysis population.~   "
202235|NCT00915304|"~     The purpose of this study is to analyze the effect of the Evidence-Based Medicine electronic~     Decision Support (EBMeDS) automatic reminders in primary health care.~      Hypothesis (1)is that in the intervention group the total number of EBMeDS reminders will~     decrease compared to the control group.~      Hypothesis (2) is that in the intervention group the quality measures will increase faster~     compared to the control group at follow-up time.~   "
202236|NCT00915291|"~     The purpose of this study is to determine whether physicians can be educated to better handle~     inappropriate requests from patients for direct-to-consumer advertised prescription~     medications.~   "
202241|NCT00915226|"~     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in~     perfusion pressure. The existence of an effective autoregulation in the optic nerve head~     (ONH) circulation has been shown in animals and humans. Moderate elevation of intraocular~     pressure (IOP) caused only slight effect on ONH blood flow in monkeys, cats and rabbits. In~     humans, during an artificial IOP rise using a suction cup method the ONH blood flow maintains~     almost constant until IOP reaches 40-55 mmHg. During isometric exercise the upper limit of~     autoregulation appears to be approximately 40% above the baseline ocular perfusion pressure.~     The mechanism behind ONH blood flow autoregulation is still unknown. The present experiments~     are designed to improve the investigators' knowledge of the physiology of regulatory~     mechanisms in ONH circulation, which may be helpful for a better understanding of blood flow~     abnormalities in glaucoma. This is of importance, because there is an increased evidence,~     that vascular dysregulation plays a role in the development of glaucomatous damage.~   "
202242|NCT00915213|"~     The purpose of this study is to discover how often certain bacteria are found in the rectum~     at the time of a prostate needle biopsy to diagnose prostate cancer. Certain bacteria are of~     importance because they can cause serious infection. Antibiotics that urologists commonly use~     to prevent these bacteria from causing infection are no longer effective. Many physicians~     around the world are noting increased infections with antibiotic resistant bacteria.~     Therefore; despite treating patients who are to undergo prostate biopsy with antibiotics,~     certain patients are being readmitted to the hospital with a serious infection. In order to~     study the incidence of these particular bacteria, the best method is to culture the bacteria~     at the time of the biopsy. This involves one rectal culture swab just prior to needle biopsy~     of the prostate. Once the incidence of these bacteria is known we may take steps to prevent~     the serious infections that occur as a result of prostate biopsy.~   "
202243|NCT00915200|"~     The study is designed to test if the combination of two potent antioxidant nutritional~     supplements, N-acetylcysteine and the milk thistle extract silibin, is capable of correcting~     the shedding of urine protein, the oxidative stress, and the inflammation in patients with~     type 2 diabetes mellitus and diabetic kidney disease.~   "
202244|NCT00915187|"~     To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery~     system (VaxiSomeTM=CCS-Cholesterol [CCS/C]), combined with commercial influenza vaccine in an~     elderly healthy population when given once intramuscularly (IM).~   "
202245|NCT00915174|"~     Primary:~      To assess the effects of repeated dose of Neramexane on the steady-state pharmacokinetics of~     Drospirenone [DRSP] and Ethinyl Estradiol [EE]~      Secondary:~      To assess safety and tolerability of concomitant repeated dose treatments of Neramexane and a~     fixed-combinational DRSP- and EE-containing oral contraceptive [OC] (Yasmin®)~   "
202246|NCT00915161|"~     Collections of fluid around the lung (pleural effusions) are common in patients on mechanical~     ventilation. Long stays on mechanical ventilation can lead to serious complications such as~     pneumonia and are associated with significant morbidity and mortality. The drainage of~     pleural effusions may lead to improvements in oxygenation making it easier to discontinue~     mechanical ventilation.~      The purpose of this study was to examine the effects of thoracocentesis (pleural fluid~     drainage) on blood oxygenation over a 48 hour period to see whether the effects are sustained~     and therefore helpful in this discontinuation.~   "
202247|NCT00915148|"~     This observational study is designed to correlate findings on ultrasound with manual~     palpation, and to consider if delivery outcome can be predicted with help of ultrasound.~     Specifically, the study will evaluate the significance of fetal head level (descent) in the~     pelvis, measured with ultrasound.~   "
202248|NCT00915135|"~     The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in~     Japanese subjects with Chronic Insomnia~   "
202249|NCT00915122|"~     The purpose of this study is to determine the feasibility and late toxicity of dose escalated~     radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the~     treatment of high risk prostate cancer. All eligible patients with high risk prostate cancer~     who are going to have primary radiation therapy to the pelvic lymph nodes and prostate~     seminal vesicles with or without concurrent hormonal therapy will be approached regarding~     study entry.~   "
202250|NCT00915109|"~     The purpose of this study is to evaluate whether there are quantifiable differences in~     walking stability, as measured by the acceleration of the trunk or the variation in step~     length, between people with unilateral below-knee amputations from vascular reasons or from~     trauma reasons.~   "
202251|NCT00915096|"~     The purpose of the study is to assess in a prospective series of patients with high tumor~     burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET~     performed over (after 4 treatments), and at the end of the first-line treatment on~     progression-free survival at 2 years.~   "
202252|NCT00915083|"~     The purpose of the study is to determine whether amrubicin is safe and effective in the~     treatment of patients with advanced solid tumors. The study will assess the pharmacokinetics~     of the amrubicin and if it has an effect on the heart.~   "
202253|NCT00915070|"~     Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance~     to changes in perfusion pressure. In the eye, several studies have reported that retinal~     blood flow is autoregulated over a wide range of ocular perfusion pressures. The~     investigators could recently show that Endothelin-1 is a key metabolite in the regulation of~     vascular tone in the eye and plays an important role in the blood flow autoregulation of the~     choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the~     present study is designed to test the hypothesis that Endothelin-1 plays also a role in optic~     nerve head blood flow autoregulation.~      Therefore, subjects will perform squatting to increase systemic perfusion pressure during~     administration of either an endothelin A-receptor blocker (BQ-123) or placebo. Optic nerve~     head blood flow will be continuously measured during the procedure to investigate optic nerve~     head autoregulation.~   "
202272|NCT00914823|"~     The investigators are seeking participants for a study of the role of kisspeptin in the~     reproductive system. Kisspeptin is a naturally occuring hormone in humans that stimulates the~     production of reproductive hormones. The investigators hypothesize that kisspeptin~     administration will be a useful tool for characterizing certain reproductive disorders.~   "
204539|NCT00884364|"~     The trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy~     for the treatment of a hematological neoplastic disease.~   "
202254|NCT00915057|"~     Little is known about the nature and extent of the disturbance in hepatic function and~     biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the~     functional implications and response to treatment are difficult to predict. This study aims~     to assess this in patients with chronic viral hepatitis B (CHB) and chronic viral hepatitis C~     (CHC) who are eligible for treatment in accordance with the established consensus guidelines~     in the involved countries. The pharmacokinetics of NRL972 will be determined at baseline~     (within one month of starting treatment), at 3-monthly intervals during treatment, for up to~     12 months (or at the end of treatment), and at 3 and 6 months after the end on treatment.~     This will provide a clearer understanding regarding the use of the pharmacokinetics of NRL972~     in detecting changes in biliary clearance during and after treatment for CHB and CHC.~   "
202255|NCT00915044|"~     The purpose of this study is to examine the effects of different environmental factors on~     immune cells in patients with IBD.~   "
202256|NCT00915031|"~     Robotic assisted laparoscopic radical prostatectomy (RLP) has gained widespread acceptance as~     a standard treatment for clinically localized prostate cancer. Despite the enhanced~     visualization and precise dissection afforded by the robotic platform, two major~     comorbidities affect a significant number of men: incontinence and erectile function.~      Urinary continence and erectile function~      It is commonly believed that the most important factor affecting continence is preservation~     of the external urinary sphincter complex which lies just below the prostate. Trauma to the~     urethral tissue itself after it is transected from the prostate and damage to the autonomic~     nerves that control this sphincter may lead to sphincteric dysfunction. In addition,~     dissection of the bladder may lead to bladder irritability which also plays a role in~     incontinence. Surgical removal of the prostate also causes significant inflammatory damage to~     the pelvic floor which likely delays recovery of urinary continence. The same trauma issues~     apply to sexual function.~      One possible method to protect the nerves and other tissues from operative trauma may be the~     use of local hypothermia (cold-ischemia) to the pelvis. Local tissue hypothermia using ice,~     ice slush, or cold irrigation has been safely and routinely used for decades in humans during~     brain, heart, and kidney surgery to minimize organ damage. Yet, this technique has never been~     applied to prostate surgery. We will accomplish local cooling of the pelvis using a cooling~     balloon inserted into the rectum. The cooling balloon is powered by an FDA approved cooling~     system developed by Innercool therapies. Temperatures of 57-86 degrees F (22+/-8 degrees C).~      References~        1. Khan F, Rodriguez E, Finley DS, Skarecky DW, Ahlering TE. Spread of thermal energy and~          heat sinks: implications for nerve-sparing robotic prostatectomy. J Endourol. 2007~          Oct;21(10):1195-8.~        2. Weld KJ, Koziol S, Montiglio C, Sorenson P, Cespedes RD, Bishoff JT. Feasibility of~          laparoscopic renal cooling with near-freezing saline irrigation delivered with a~          standard irrigator aspirator. Urology. 2007 Mar;69(3):465-8~        3. Gill IS, Abreu SC, Desai MM, Steinberg AP, Ramani AP, Ng C, Banks K, Novick AC, Kaouk~          JH.~           Laparoscopic ice slush renal hypothermia for partial nephrectomy: the initial~          experience.~           J Urol. 2003 Jul;170(1):52-6.~        4. Wakabayashi Y, Narita M, Kim CJ, Kawakami T, Yoshiki T, Okada Y. Renal hypothermia using~          ice slush for retroperitoneal laparoscopic partial nephrectomy. Urology. 2004~          Apr;63(4):773-5.~        5. Wagner KR, Zuccarello M. Local brain hypothermia for neuroprotection in stroke treatment~          and aneurysm repair. Neurol Res. 2005 Apr;27(3):238-45~        6. Iwata O, Thornton JS, Sellwood MW, Iwata S, Sakata Y, Noone MA, O'Brien FE, Bainbridge~          A, De Vita E, Raivich G, Peebles D, Scaravilli F, Cady EB, Ordidge R, Wyatt JS,~          Robertson NJ . Depth of delayed cooling alters neuroprotection pattern after~          hypoxia-ischemia. . Ann Neurol. 2005 Jul;58(1):75-87~        7. Zhao H, Wang JQ, Shimohata T, Sun G, Yenari MA, Sapolsky RM, Steinberg GK.Conditions of~          protection by hypothermia and effects on apoptotic pathways in a rat model of permanent~          middle cerebral artery occlusion. J Neurosurg. 2007 Sep;107(3):636-41.~        8. Ridenour TR, Warner DS, Todd MM, McAllister AC. Mild hypothermia reduces infarct size~          resulting from temporary but not permanent focal ischemia in rats. Stroke. 1992~          May;23(5):733-8.~        9. Sahuquillo J, Vilalta A. Cooling the injured brain: how does moderate hypothermia~          influence the pathophysiology of traumatic brain injury. Curr Pharm Des.~          2007;13(22):2310-22~   "
202257|NCT00915018|"~     This study is investigating the effects of an experimental drug (neratinib) in combination~     with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women~     who have not received previous treatment for erbB-2-positive locally recurrent or metastatic~     breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors~     and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will~     also compare the safety of the two regimens and as well as the quality of life of subjects~     receiving either regimen.~   "
202258|NCT00915005|"~     The goal of this clinical research study is to learn if, compared with regular x-ray~     radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis~     (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in~     patients with lung cancer.~   "
202259|NCT00914992|"~     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in~     perfusion pressure. The existence of an effective autoregulation in the optic nerve head~     (ONH) circulation has been shown in animals and humans. Moderate elevation of intraocular~     pressure (IOP) caused only slight effect on ONH blood flow in monkeys, cats and rabbits. In~     humans, during an artificial IOP rise using a suction cup method the ONH blood flow maintains~     almost constant until IOP reaches 40-55 mmHg. During isometric exercise the upper limit of~     autoregulation appears to be approximately 40% above the baseline ocular perfusion pressure.~     The mechanism behind ONH blood flow autoregulation is still unknown. The present experiments~     are designed to improve the investigators' knowledge of the physiology of regulatory~     mechanisms in ONH circulation, which may be helpful for a better understanding of blood flow~     abnormalities in glaucoma. This is of importance, because there is increasing evidence that~     vascular dysregulation plays a role in the development of glaucomatous damage.~   "
202260|NCT00914979|"~     Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of~     bifurcation lesions in native coronary arteries.~   "
202261|NCT00914966|"~     The objectives of the study were:~        1. To assess the safety and tolerability of escalating doses of CINRYZE.~        2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary~          angioedema (HAE) attack rates.~        3. To assess the immunogenicity of CINRYZE.~   "
202262|NCT00914953|"~     This study will investigate if intranasal oxytocin (a hormone naturally produced in the body)~     promotes motivation for, and engagement in, social activities in older adults.~   "
202263|NCT00914940|"~     RATIONALE: Allogeneic hematopoietic stem cell transplant (HSCT) is a treatment that can cure~     acute leukemia and myelodysplasia. After giving the patient chemotherapy and total body~     irradiation to stop the growth of cancer and remove the patient's diseased bone marrow,~     healthy stem cells from a donor are infused into the patient to replace the patient's bone~     marrow and make red and white blood cells and platelets. Unfortunately HSCT is often~     complicated by 'graft versus host disease' (GVHD) in which the transplanted cells from a~     donor can make an immune response against the body's normal cells and cause tissue damage and~     severe symptoms. Removing a subset of the donor T cells, called 'naive T cells', before~     transplant may reduce the frequency and intensity of GVHD.~      PURPOSE: This phase II trial will determine whether the removal of the naive T cells from~     donor cells can decrease the rate and severity of graft-vs-host disease while preserving~     specific immunity against infections in patients with acute leukemia or advanced~     myelodysplastic syndromes.~   "
202264|NCT00914927|"~     The purpose of this study is to evaluate the efficacy of once-daily Oral avatrombopagin~     subjects with chronic liver diseases and thrombocytopenia prior to elective surgical or~     diagnostic procedures, to evaluate the safety of short-term administration of avatrombopag~     and to evaluate the pharmacokinetics (PK) of E5501.~   "
202265|NCT00914914|"~     The purpose of this study is to evaluate the safety of an experimental drug (p28) as a~     treatment for certain advanced cancers which express a protein called p53 and which have not~     responded to prior treatment.~   "
202266|NCT00914901|"~     The purpose of the study is to assess the blood and urine concentrations of inhaled~     salmeterol.~   "
202267|NCT00914888|"~     The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone~     regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal~     infections (cIAI) and community acquired pneumonia (CAP).~   "
202268|NCT00914875|"~     double blind study of kidney function of two groups of adult patients submitted to~     laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac~   "
202269|NCT00914862|"~     The purpose of this study is to determine the pharmacokinetic profile, safety, and~     tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit~     Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy~     adults.~   "
202270|NCT00914849|"~     To reduce the number of donors treated with IV AMD3100 who require a second collection to~     obtain the minimum cells necessary for allogeneic stem cell transplant.~   "
202271|NCT00914836|"~     The use of corticosteroid subacromial injections have been found to be effective for the~     treatment of shoulder pain. Higher doses may be better than lower doses for subacromial~     corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to~     compare 2 doses of corticosteroids.~   "
207360|NCT00846963|"~     The purpose of this study is to determine whether ursodiol is effective in the treatment of~     parenteral nutrition associated cholestasis in neonates.~   "
202274|NCT00914797|"~     The purpose of this study is to assess the blood and urine concentrations of terbutaline and~     to evaluate the difference between inhaled and oral terbutaline in order to distinguish~     treatment with terbutaline from doping with terbutaline in a doping control.~   "
202275|NCT00914784|"~     Currently Transfusion-related acute lung injury (TRALI) is the leading cause of~     transfusion-related mortality in the United States, and one of major post-transfusion~     complications. TRALI is defined as new ALI occurring within 6 hours from the onset of~     transfusion. It is manifested by acute dyspnea, hypoxemia and bilateral infiltrates in chest~     radiograph. TRALI may be caused by any blood product and is not dose-dependent. Associated~     risk factors include prolonged storage of blood products and underlying conditions such as~     severe IHD hematologic malignancies or active infections. Since TRALI has only recently been~     defined as a clinical entity, and its prevalence has been largely underestimated - the~     epidemiology of TRALI is not well established. Therefore the objective of this work is to~     study the incidence of TRALI in a patient population that receive blood products frequently,~     namely orthopedic-oncologic.~   "
202276|NCT00914771|"~     This study aims to demonstrate the non-inferiority of two doses of H5N1 influenza antigen in~     non-elderly and elderly adult subjects in order to submit an extension application for a~     lower dose of Focetria.~   "
202277|NCT00914758|"~     People with multiple sclerosis (MS) often experience problems with cognitive functioning,~     which can be debilitating and interfere with their daily functioning. However, research has~     shown that MS disease modifying agents have had some success in treating cognitive problems.~     The main purpose of this research study is to investigate how well two medicines (alemtuzumab~     (Campath®) and interferon beta-1a (Rebif®)) work in treating MS-related cognitive problems~     (e.g., attention, memory, speed of thinking). Participants enrolled will be assessed prior to~     their first study-related medication dose and re-assessed throughout treatment. It is~     expected that participants taking Campath® will demonstrate relative stability in cognitive~     functioning relative to those taking Rebif®. Specifically, the cognitive performance of~     Rebif® participants will decline somewhat over time, but the cognitive performance of~     Campath® participants will remain stable.~   "
202278|NCT00914745|"~     About 80% of the worldwide population is positive on HSV antibodies. In the United States the~     lifetime prevalence of recurrent herpes labialis is estimated at 20% to 40%, with~     approximately 100 million episodes occurring in the country every year. In Switzerland about~     70% of the adult population is positive on HSV-1 and about 20% is positive on HSV-2.~      The Herpes simplex virus has a lipid bilayer (virus-envelope), which causes the~     sensitiveness, to any kind of detergents. Within this bilayer cholesterol molecules are~     integrated and play a crucial role in virus entry into host cells. In vitro experiments have~     clearly shown that the depletion of cholesterol in HSV-envelope with 2- HPßCD has inhibited~     the ability of the virus to infect host cells.~      The aim of this clinical trial is to reduce the number of Herpes labialis relapse and to~     provide patients with recurrent Herpes labialis a real benefit, concerning the simple~     mechanism of action and the negligible side effects. Patients having problems in swallowing~     the antiviral pills of standard treatment, will find with 2- HPßCD a drug, that just has to~     be applied on the lips, which increases patient's quality of life tremendously.~        -  Trial with medicinal product~   "
202279|NCT00914732|"~     Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to~     improve its ability to protect citizens against the smallpox virus. This study will evaluate~     safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the~     immune system (the body's defense system). Two vaccine preparations have the same name but~     one is a liquid and one is a powder that has liquid added just before it is given. The~     vaccine that comes as a liquid will be injected (given as a shot) just under the skin~     (subcutaneously) or injected between the layers of the skin (intradermally). The powder~     formulation is only injected just under the skin. Approximately 495 adults, age 18 older born~     after 1971, which have not had smallpox vaccine before, may participate in the study for~     about 7 months.~   "
202280|NCT00914719|"~     Adolescents are at great risk for sexually transmitted diseases (STDs) including the human~     immunodeficiency virus (HIV) (CDC, 2000a; DiLorenzo & Whaley, 1999). Though the CDC (2000b)~     reports that overall AIDS incidence is on the decline, there has been no comparable decline~     in the number of newly diagnosed HIV cases among young people aged 13-19, and young people of~     color are particularly at risk. Compared to the general adolescent population, adolescents~     involved with the criminal justice system are younger at first intercourse, have a greater~     number of sex partners, and lower rates of condom use, resulting in higher rates of~     unintended pregnancy and STDs (e.g., St. Lawrence et al., 1999). Alcohol use is commonly~     cited as a reason for lack of condom use among high-risk adolescents such as those involved~     in the criminal justice system (e.g., Morris et al., 1998) and recent data from our research~     suggests that it is heavy alcohol use in concert with sexual activity that is most strongly~     related to lack of condom use (Bryan, Rocheleau, & Robbins, 2002a). The goal of this research~     is to design, implement, evaluation, and disseminate a successful HIV/STD risk reduction~     intervention that is theory-based, empirically targeted to adolescents, and articulated to a~     criminal justice setting. The study compares a sexual risk reduction intervention with a~     group motivational interviewing alcohol component to a standard sexual risk reduction~     intervention and a no treatment control condition. The investigators hope to show that: 1) A~     three-hour one-time intervention has the capacity to reduce sexual risk behavior up to one~     year post-release among high risk adolescents in detention, 2) A combined sexual and alcohol~     risk reduction intervention will result in larger decreases in sexual risk behavior than a~     sexual risk reduction alone, 3) The interventions will exert their effects through changes in~     mediators derived from a theoretically-based model of condom use intentions and behaviors,~     and 4) A sexual risk reduction intervention including an alcohol component will be especially~     effective for those adolescents with higher levels of existing alcohol problems. Finally,~     given proven efficacy, the intervention curricula and materials will be disseminated for use~     in adolescent detention facilities throughout the state.~   "
202281|NCT00914706|"~     The purpose of this study is to evaluate the impact of using a web-based (P-PROMPT) chronic~     disease management system (CDMS) by primary care practitioners and their team members and on~     their care for patients with diabetes. The system will help to ensure that all patients have~     up-to-date laboratory monitoring and visits as recommended by the Canadian Diabetes~     Association Guidelines. The hypothesis is that the use of a CDMS in Ontario primary care~     practices, as a part of the routine clinical management of diabetes patients, can improve~     monitoring frequency of A1C, blood pressure (BP) and cholesterol levels. The results of this~     study will serve as a benchmark for the utilization of chronic disease management software~     tools in primary care diabetes management for patients in Ontario, establishing and providing~     evidence to inform decision-makers. If the results are favorable towards CDMS interventions~     for the management of diabetes, potential expansion and availability of these types of~     programs may be possible for other chronic diseases.~   "
202282|NCT00914693|"~     The aim of the present study is to prove efficacy and safety of a new contraceptive patch.~   "
202283|NCT00914680|"~     This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic~     seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive~     episode. The investigators will perform add-on tests to assess clinical and cognitive~     response to treatment. It is hypothesized that MST will have an antidepressant efficacy with~     a beneficial neurocognitive adverse effect profile.~   "
202284|NCT00914667|"~     This is an open-label, randomized, two-way crossover study to evaluate the steady-state~     effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single~     supratherapeutic dose of warfarin (25 mg) in healthy subjects.~   "
202285|NCT00914654|"~     The purpose of the study is to assess the blood and urine concentrations of inhaled~     formoterol.~   "
202286|NCT00914641|"~     To estimate the pharmacokinetics of apixaban when administered as three different modified~     release formulation tablets relative to that when apixaban is administered as an immediate~     release tablet~   "
202287|NCT00914628|"~     The main objective of this randomized trial is to compare disease-free survival (DFS) in high~     risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of~     HSV-Tk donor lymphocytes or standard haploidentical HCT~   "
202288|NCT00914615|"~     This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce~     tumour size, slow progression of the disease, prolong life and improve quality of life. SBRT~     is concentrated focused radiation therapy delivered very precisely to the liver tumour.~      Presently, the treatment for unresectable liver metastases from colorectal cancer is most~     often chemotherapy or novel targeted therapy. These treatments may improve survival, but not~     control the metastases permanently; so new treatments are needed to control metastases. It is~     hoped that knowledge obtained from this study will improve our ability to treat patients with~     liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove~     to be a treatment that can lead to long-term and permanent control of liver tumours for some~     patients.~   "
202289|NCT00914602|"~     The purpose of the study is to assess the pharmacokinetics (PK), pharmacodynamics, and safety~     of XP21279 sustained release (SR3) formulation [administered with Lodosyn® (carbidopa)] and~     Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.~   "
202290|NCT00914589|"~     This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to~     investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart~     surgery.~   "
202291|NCT00914576|"~     Oxidative stress has been implicated in playing a pathogenic role in many disease processes,~     especially in age-related disorders. It has been hypothesized that antioxidative agents such~     as vitamins and minerals, which are capable of scavenging free radicals, may reduce oxidative~     stress and may, in turn, be beneficial for patients with age-related disorders. Based on this~     hypothesis, several different combinations of vitamins have been introduced, all targeting at~     reducing oxidative stress. However, the in-vivo determination of the antioxidative properties~     of a certain drug or vitamin combination are hard to determine. In the current study, the~     researchers propose to investigate the effect of VITAMAC®, a combination of vitamins and~     minerals, in a systemic in-vivo inflammation model.~      In the present study, the infusion of LPS, which is a cell wall component of Gram-negative~     bacteria and a major mediator in the pathogenesis of septic shock, will be used as a~     standardized experimental model of systemic inflammation in humans. Given that inflammation~     is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS~     model is well suitable for determination of the antioxidative effects of VITAMAC®. As a main~     outcome parameter, the vascular reactivity of retinal vessels to systemic hyperoxia (induced~     by breathing 100% oxygen) will be tested in presence or absence of the antioxidant~     combination.~   "
202292|NCT00914563|"~     Fluid Therapy Lithium Dilution Cardiac Output (LIDCO) controlled trial in BURNS (FACT in~     BURNS) is a prospective randomized multicentric study.~      Introduction: The goal of this trial is the verification, optional upgrading and optimizing~     of the resuscitative patterns in light of the new generation of balanced crystalloids and~     colloids and, by utilization the non-invasive hemodynamic monitoring LIDCO.~   "
202293|NCT00914550|"~     The purpose of the study is to learn if a blood test is helpful to the doctors in deciding~     whether you need antibiotic therapy for possible pneumonia. The blood test is called a~     Procalcitonin level and sometimes the test reflects infection with certain bacteria (germs).~     When the doctors learn the results of these blood tests, they may be able to stop some of the~     antibiotic medications that they may have given to the patients. The study is designed, so~     that on a randomized basis (50/50 chance) the results from measuring Procalcitonin will be~     given to the patients' doctor. When the doctor receives these results, he/she may use this~     information, along with other information, to decide whether to continue antibiotic therapy.~   "
202294|NCT00914537|"~     Background:~        -  HIV-positive men who have sex with men (MSM) have rates of anal cancer that approach~          those of cervical cancer in women. However, unlike cervical cancer, there is no current~          recommended method of screening that could be used to detect anal precancerous lesions~          for the prevention of anal cancer in HIV-positive MSM.~        -  Infections by human papillomavirus (HPV) are the likely cause of cervical and anal~          precancer and cancer. Detecting the presence of HPV or related biomarkers has helped to~          identify women who may be at increased risk of cervical cancer; researchers believe that~          early detection of HPV or related biomarkers in MSM may be useful for anal cancer~          screening.~      Objectives:~      - To evaluate the effectiveness of various tests to detect cancer-causing HPV in HIV-positive~     men who have sex with men.~      Eligibility:~      - HIV-positive MSM that are interested in receiving anal screening for precancer~      Design:~        -  HIV-positive MSM will respond to a self-administered risk factor questionnaire, and will~          undergo a physical exam and a high-resolution anoscopy at the participating clinic.~        -  The clinician will then collect to anal Pap specimens from each subject for research on~          HPV and related biomarkers.~        -  Participants will be followed annually for 2 years to collect additional health data for~          research follow-up.~   "
202295|NCT00914524|"~     The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg,~     20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for~     efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of~     treatment. The secondary endpoint was creatinine clearance (Ccr).~   "
202296|NCT00914511|"~     The purposes of this study are to:~        -  Determine the effect of the study drug on sperm and semen of healthy young male~          subjects.~        -  Determine the effect of age on the amount of study drug in the blood of healthy subjects~        -  Learn about the safety of the study drug.~        -  Learn how subjects tolerate the study drug.~   "
202297|NCT00914498|"~     This study will examine whether pre-incision infiltration of the skin cut site can attenuate~     post operative pain after a cesarean section. One hundred and twenty women will be allocated~     to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also~     examine possible effect of this infiltration of parameters of wound heeling and scar~     formation, six weeks post partum.~   "
202298|NCT00914485|"~     The proposed research will provide important insight into two serious problems for veterans'~     healthcare: 1) mixed effectiveness of communication improvement interventions in the VA to~     date, and 2) persistence of racial/ethnic disparities in VA healthcare.~   "
202299|NCT00914472|"~     Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin~     sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients~     on hemodialysis due to renal failure, through the control of hemostasis, verified by~     formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA~     and Anti-Xa) during the use of heparin~   "
202300|NCT00914459|"~     The study will be investigating pharmacokinetics, safety and efficacy in patients less than~     12 years of age with severe hemophilia A that have been previously treated with Factor VIII~     products ( including blood products).~   "
202301|NCT00914446|"~     The main aim of this work will be to identify a profile of gene expression by microarray in~     the liver which might allow to differentiate obese subjects having a normal liver from those~     with steatohepatitis or steatosis.~   "
202302|NCT00914433|"~     This study will look at the safety and tolerability of TPI 1100 in healthy volunteers and~     look at pharmacodynamic (PD) effect on mRNA expression of PDE 4B/D & 7A in blood and in~     sputum.~   "
202303|NCT00914420|"~     Patients presenting with ACS (Acute Coronary Syndrome) in the emergency department will be~     screened for clinical eligibility and asked to sign informed consent to the study.~      A total of 40 patients will be randomized. 20 of them will receive a Trapidil eluting stent~     (Intrepide™ stent), 20 will receive a Paclitaxel eluting stent (Taxus™ stent). After 90 days~     the patients who were treated with the INTREPIDE stent in the first lesion will be treated~     with the Taxus stent in the second lesion. After 90 days the patients who were treated with~     the Taxus stent in the first lesion will be treated with the INTREPIDE stent in the second~     lesion.~      Coronary angiography will be performed through the femoral (groin) or radial (wrist) artery~     with the use of standard techniques. The doctor will determine if the patient is qualified~     for enrolment at the end of the diagnostic coronary angiogram~   "
202304|NCT00914407|"~     The inner retina is crucially dependent on an adequate retinal blood supply. When the retina~     becomes ischemic and hypoxic this results in severe vision loss due to retinal~     neovascularization. Measurement of retinal blood flow and retinal oxygenation is, however,~     still a difficult task. Information on retinal oxygenation is almost unavailable from human~     studies. In the present protocol the investigators propose a procedure allowing for the~     measurement of retinal blood flow, retinal oxygenation and retinal oxygen extraction by~     combining a number of innovative techniques. Specifically, retinal vessel diameters will be~     measured with a Retinal Vessel Analyzer, retinal blood velocities with bi-directional laser~     Doppler velocimetry and retinal oxygenation with spectroscopic evaluation of retinal fundus~     images. This will allow for the calculation of retinal oxygen extraction, a fundamental~     parameter of retinal function. Up to now, no data for retinal oxygen extraction are available~     in the literature.~   "
202305|NCT00914394|"~     Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance~     to changes in perfusion pressure. In the eye, several studies have reported that retinal~     blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale~     studies have shown that reduced ocular perfusion pressure is an important risk factor for the~     prevalence, the incidence and the progression of primary open angle glaucoma.~      Former studies that investigated ocular blood flow autoregulation focused mainly on choroidal~     blood flow. For the optic nerve head only few data are available, although it seems likely~     that it underlies similar autoregulatory mechanisms.~      A previous study investigating choroidal blood flow has shown that nitric oxide (NO) plays a~     key role in choroidal autoregulation. The present study is designed to test the hypothesis~     that NO plays a role in optic nerve head autoregulation during increased intraocular pressure~     (IOP). Therefore, IOP will be experimentally increased using a suction cup device in the~     absence of presence of either a nitric oxide synthase inhibitor (L-NMMA), an α-receptor~     agonist (phenylephrine) or placebo. Optic nerve head blood flow will be continuously measured~     during the procedure.~   "
202306|NCT00914381|"~     To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation~     (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent~     voucher control (VC) for the treatment of cocaine dependent pregnant women or women with~     young children.~   "
202307|NCT00914368|"~     The primary objective of this study is to establish a cut off level of platelet inhibition~     that separates patients with or without previous stent occlusion with acute clinical onset~     while on aspirin and clopidogrel treatment within 6 months after coronary stenting for~     coronary artery disease.~   "
202308|NCT00914355|"~     This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce~     tumour size, slow progression of the disease, prolong life and improve quality of life of~     patients with hepatocellular carcinoma, a cancer of the liver, that cannot be removed~     surgically (unresectable) and cannot be treated with ablative therapy (e.g. radio-frequency~     ablation) or trans-arterial chemo-embolization (TACE) therapy (delivery of chemotherapy~     through an artery that feeds into the liver). SBRT is concentrated focused radiation therapy~     delivered very precisely to the liver tumour. It is hoped that knowledge obtained from this~     study will improve our ability to treat patients with liver tumours that cannot be treated~     with surgery and other methods, and that SBRT may prove to be a treatment that can lead to~     long-term and permanent control of liver tumours for some patients.~   "
202600|NCT00910520|"~     The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A~     (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary~     incontinence.~   "
202309|NCT00914342|"~     The purpose of the study is to provide data on the GERD prevalence as percentage of patients~     with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire.~     Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as~     they respond to a physician's questionnaire, to observe possible variations between the two~     methods (physicians' symptom rating and GerdQ), to objectively measure treatment response and~     to identify the percentage of patients that may require alterations of their treatment.~     Finally, to describe the impact of GERD symptoms on work productivity.~   "
202310|NCT00914329|"~     To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked~     anxiety, in healthy volunteers.~   "
202311|NCT00914316|"~     The goal of this study is to evaluate whether supervised treadmill exercise combined with~     ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance~     over supervised exercise alone in patients with stable claudication. Investigators also seek~     to determine if the administration of ranolazine provides a sustained benefit after the~     completion of a supervised exercise regimen. Lastly, investigators wish to determine whether~     both exercise and ranolazine improves peak oxygen consumption and anaerobic threshold in~     patients with stable claudication.~   "
202312|NCT00914303|"~     The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER~     tablets of AZD3241 following multiple ascending doses administered to healthy male and female~     subjects including the effect of food.~   "
202313|NCT00914290|"~     To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation~     of symptoms of spasticity associated with multiple sclerosis (MS).~   "
202314|NCT00914277|"~     The primary objective of this clinical trial is to study the ability of SAR407899 to increase~     the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.~      The secondary objectives of this clinical trial are to study the ability of SAR407899 to~     shorten increase the time to erection duration of penile erection in male patients with~     mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of~     SAR407899 in these patients.~   "
202315|NCT00914264|"~     1. The first objective of this study is to determine the differences between, while the~          airway obstruction severity is the same, and the acute continuous positive airway~          pressure (CPAP) effect on chronic obstructive pulmonary disease (COPD) patients with~          overlap syndrome compared with COPD patients without in terms of sleep quality,~          autonomic nerve activity, biologic markers of systemic inflammatory, and exercise~          performance.~        2. The second objective of this study is to evaluate the subacute (3 months treatment) CPAP~          effect on COPD patients with overlap syndrome in terms of pulmonary hemodynamic and~          right heart function, We will also determine the subacute effect of CPAP on sleep and~          life quality, autonomic nerve activity, biologic markers of systemic inflammatory, as~          well as exercise performance.~        3. The last objective of this study is to evaluate the long term (12 months treatment) CPAP~          effect on COPD patients with overlap syndrome. The un-scheduled clinic or emergency~          department visiting, hospitalization, or mortality will be recorded to see if there is~          significant treatment effect in terms of reducing morbidity and mortality. The long term~          CPAP effect on sleep and life quality, autonomic nerve activity, biologic markers of~          systemic inflammatory, exercise performance, as well as pulmonary hemodynamic and right~          heart function will be re-evaluation.~   "
202316|NCT00914251|"~     It has been suggested that cardiovascular risk factors either independently or in cluster~     (metabolic syndrome) increase the risk of both type 2 diabetes (DM2) and cardiovascular~     diseases (CVD). Consumption of citrus fruits is linked to reduced cardiovascular morbidity~     and mortality. Hesperidin is a flavanone abundant in citrus fruit with putative vasodilator~     actions in vitro. While molecular mechanisms of vascular actions of hesperidin begin to be~     explored, no data on in vivo vascular effect of this flavanone has been ever acquired.~   "
202317|NCT00914238|"~     In a randomized clinical trial, the researchers want to investigate if the positive~     short-term outcomes (first 1-2 years), achieved with specialized assertive intervention~     programme (OPUS), can be maintained for five years if the specialized treatment is sustained~     over the first five years in comparison to only two years of specialized treatment followed~     by three years of standard treatment.~   "
202318|NCT00914225|"~     In many areas of the world most severely affected by the HIV/AIDS pandemic, insect and~     water-borne diseases such as malaria and diarrheal disease are common causes of illness and~     death. In addition, diarrhea and malaria are more common and more severe among adults and~     children infected with HIV. These infections may modulate the immune system, affect the~     replication of the HIV virus and could result in more rapid HIV disease progression in~     co-infected individuals. Access to practical, inexpensive and easy to use interventions to~     prevent these diseases may be effective in delaying HIV progression.~      Current Kenya government and World Health Organization guidelines recommend the use of~     cotrimoxazole (trimethoprim-sulfamethoxazole [TMP/SMX]) to prevent co-infections, including~     malaria. Despite the provision of TMP/SMX to HIV-infected adults, infections with malaria and~     pathogens causing diarrhea remain common causes of morbidity and mortality in many~     resource-limited settings. In addition, TMP/SMX may not prevent all infections with malaria~     or other pathogens due to alternative mechanisms of action, antimicrobial resistance and~     non-compliance due to adverse events or other reasons.~      We propose a study to evaluate the impact of providing insecticide treated bednets and a~     simple water filtration device on markers of HIV disease progression among a cohort of ART~     naïve, HIV infected adults prescribed TMP/SMX in Kenya. In addition, we propose to evaluate~     the effect of these interventions on malaria and diarrheal disease incidence and on~     compliance with TMP/SMX.~   "
202319|NCT00914212|"~     This study will determine whether BOLD-fMRI can be used to probe hunger and satiety states in~     healthy overweight or obese men and also whether fasted/fed fMRI signals can be modulated by~     sibutramine.~   "
202320|NCT00914199|"~     Should we, or should we not, perform dilatation of the side branch through the main vessel~     stent, if there is acceptable blood flow in the side branch?~   "
202321|NCT00914186|"~     The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and~     tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe~     pruritus (itching), following a 28-day regimen of twice-daily topical application.~   "
202322|NCT00914173|"~     The clinical trial is intended to implement, validate performances and evaluate efficacy of~     the pain monitoring device for automated assessment of patient's pain level. The efficacy of~     the pain monitor will be tested by comparing its results to the patient pain reports towards~     a given pain stimuli.~   "
202323|NCT00914160|"~     To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets~     under non-fasting conditions.~   "
202324|NCT00914147|"~     RATIONALE: Measuring how well the lungs work in patients with cancer may help doctors predict~     how patients will respond to treatment and help plan the best treatment.~      PURPOSE: This clinical trial is studying lung function testing in patients with locally~     advanced or metastatic solid tumors.~   "
202325|NCT00914134|"~     The aim of the study is to assess the effect of continuous levodopa infusion on autonomic~     nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and~     sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis~     and orthostatic hypotension.~   "
202326|NCT00914121|"~     The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart~     (cardiac repolarization)~   "
202327|NCT00914108|"~     The purpose of the study is to learn more about the development of small for gestational age~     (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on~     outcome. The study hypotheses state: 1) High risk severely SGA preterm infants will profit~     from detailed neuropsychological assessment, psychoeducational recommendations and practical~     guidance for caregiving, as well as formal educational and emotional support for the family~     and the professional care team. 2) Neuropsychological education and guidance for~     community-based early intervention providers caring for SGA preterm infants after their~     discharge is effective in promoting improved outcome.~   "
202328|NCT00914095|"~     Therapeutic management of gait disorders in very advanced Parkinson's disease (PD) patients~     can sometimes be disappointing, since dopaminergic drug treatments and subthalamic nucleus~     (STN) stimulation are more effective for limb-related Parkinsonian signs than for gait~     disorders. Gait disorders could be also partly related to noradrenergic system impairment,~     pharmacological modulation of both dopamine and noradrenaline pathways could potentially~     improve the symptomatology. The investigators have demonstrated using an open label study on~     17 advanced PD patients that chronic, high doses of methylphenidate (MPD) improved gait,~     freezing of gait, motor symptoms and attention in the absence of L-Dopa and increased the~     intensity of response of these symptoms to L-Dopa (Devos et al., 2007). The investigators~     aimed to confirm their results using a randomized, double-blind, placebo-controlled,~     parallel-group, multicentric trial. The investigators will assess the clinical value of~     chronic, high doses (1 mg/kg/day) of MPD vs placebo in 88 non demented PD patients suffering~     from severe gait disorders with freezing despite their use of optimal dopaminergic doses and~     eventually STN stimulation parameters. Efficacy will be assessed directly and on video in the~     absence of L-Dopa and again after acute administration of the drug, both before and after a~     3-month course of MPD, using Stand Walk Sit test (primary criteria), the Freezing Of Gait~     trajectory, RGSE scale, the UPDRS scores, the dyskinesia rating scale, Achiron scales and~     using auto-questionnaires of Giladi, ABC scale and PDQ 39. Attention will be assessed using~     reactions times. Drowsiness will be assessed using Epworth and Parkinson's disease Sleep~     Scales. Apathy and depression will be monitored with Lille Apathy Rating Scale, MADRS, BPRS,~     MINI and psychiatric interview. Cardiologic and general tolerance will be also monitored.~     This study could lead to propose methylphenidate with a good efficacy/ risk balance in~     advanced PD patients suffering from severe gait disorders with freezing of gait, drowsiness~     and attention deficit.~   "
202329|NCT00914082|"~     Labour pain is a challenge to the parturient woman. Pain relief methods during birth are~     limited and often associated with side effects. Several studies indicate that a mental~     trainings method, self hypnosis, has a positive impact on the labour pain and other birth~     outcomes.~      The aim of this randomized controlled study is to examine the effect of a short antenatal~     course in self hypnosis on the use of epidural analgesia during birth and several other birth~     outcomes. Data collection includes questionnaires, register data, medical records and~     biological material.~   "
202330|NCT00914069|"~     The study will test a hypothesis that the RIVS system will have a higher rate of successful~     first PIV placement compared to conventional catheter without a significant increase in~     complications and time of procedure.~   "
202331|NCT00914056|"~     After resolution of the initial episode of hepatic encephalopathy (HE), lactulose is~     routinely continued indefinitely as maintenance therapy. Although widely used for this~     indication, lactulose has never been shown in randomized, controlled trials to be effective~     for preventing exacerbations of HE. Indeed, lactulose was found to be ineffective at~     preventing HE when administered prophylactically to patients undergoing portosystemic shunt~     insertion. While some patients may be lactulose dependent following an initial episode of HE,~     it is likely that most could have their lactulose discontinued with no adverse consequences.~      This goal is worth pursuing because lactulose is not innocuous. It has an unpleasant taste,~     and it routinely produces gastrointestinal symptoms, including bloating, gas and diarrhea. In~     high doses it can cause incontinence, dehydration and electrolyte derangements. Patients~     universally dislike taking lactulose and often are noncompliant with treatment. A recent~     trial showed that patients on lactulose had a substantial risk of hospital admissions due to~     lactulose-related complications and treatment non-compliance.~   "
202332|NCT00914043|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     fatigue.~      PURPOSE: This research study is looking at biological markers of fatigue in women with~     residual invasive breast cancer enrolled on clinical trial NSABP-B-45.~   "
202333|NCT00914030|"~     The aim of the protocol is to better understand the impairments in visual processing, as such~     impairments may induce social interaction difficulties in subjects with autism spectrum~     disorders (adults and children) and schizophrenia, like face exploration.The same protocol~     will be used for the three populations, each population being compared with matched controls.~     The explorations are designed to test two different hypotheses regarding the mechanisms of~     the visual perception difficulties of the two populations. Even though difficulties to~     extract the global form of objects have been described in both subjects with autism and~     schizophrenia, we will test two different hypotheses for the two populations. We will test~     the hypothesis that subjects with autism display an advantage for the processing of local~     information arising at an early level of processing, whereas disorders observed in patients~     with schizophrenia originate from attention disorders. The protocol includes three~     consecutive studies, each one being applied in each of the three populations.~   "
202346|NCT00913861|"~     The purpose of this study is to determine whether a non-pharmacological intervention reduces~     consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce~     side effects. This non-pharmacological intervention may increase patient's comfort and~     security.~   "
202334|NCT00914017|"~     There is laboratory evidence that cholesterol lowering medications (statins) inhibit the~     growth of breast cancer cells. Clinical studies are controversial but some show that women~     taking statins are less likely to get breast cancer. This ongoing randomized trial compares~     one-year of atorvastatin (Lipitor™) or placebo for lowering mammography-defined breast~     density and other surrogate markers associated with breast cancer risk.~   "
202335|NCT00914004|"~     To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg~     Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.~   "
202336|NCT00913991|"~     Systolic Hypertension is a disorder which is characterized by significant elevations in~     systolic blood pressure in association with normal diastolic blood pressure. Typically, this~     develops in individuals >50 years of age and is associated with an increased risk of stroke~     and myocardial infarction. While there are many effective therapies for essential/diastolic~     hypertension, the treatment of systolic hypertension is complicated by side effects from~     traditional therapies. This limits therapeutic options and has resulted in a number of~     at-risk individuals being left untreated.~      We are conducting a randomized, controlled trial (n=90) to compare the effects of two~     different stress management training on blood pressure. The primary outcome is change in~     systolic blood pressure and pulse pressure. Secondary outcomes are changes in nitric oxide,~     stress hormones and psychological well-being. Additional analyses will be conducted to assess~     for other confounding effects on BP and PP.~   "
202337|NCT00913978|"~     We propose a study in which we compare two intraoperative active warming devices for~     maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody~     resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M~     Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody~     resistive warming mattress will be equally effective as forced air warming in maintaining~     normothermia in colorectal surgery.~   "
202338|NCT00913965|"~     To demonstrate the relative bioavailability of Atenolol tablets.~   "
202339|NCT00913952|"~     To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg~     Clomipramine Hydrochloride capsules under fed and fasted conditions.~   "
202340|NCT00913939|"~     This pilot study initiates a research program testing the early technical and clinical~     performance of a novel procedure for MRI-guided high-dose-rate (HDR) prostate brachytherapy.~     Testing will proceed in two cohorts of patients. In Arm 1, patients with locally recurrent~     prostate cancer after radiotherapy will receive tumor-targeted salvage HDR brachytherapy. Arm~     1 of the study will be coordinated and closely integrated with a separate concurrent study of~     MRI-guided prostate biopsy, which will be performed prior to accrual to Arm 1 of this trial~     (UHN 05-0641-C). In arm 2, patients with locally advanced prostate cancer will receive a~     boost of prostate-targeted HDR brachytherapy during external beam radiotherapy.~      This technique will be prospectively evaluated in up to 100 patients. Preliminary data~     acquired in this pilot study will determine the technical limits of MRI guided HDR~     brachytherapy and will be critical for the judicious conduct of a subsequent phase II~     clinical trial.~      This proposal is innovative in two fundamental ways: MRI-guidance, and specific tumor~     targeting for HDR brachytherapy. Successful completion of this study will further~     individualize local therapy, not only for the benefit of the proportion of cancer patients~     for whom initial radiotherapeutic interventions have failed, but also provide valuable~     technical and clinical validation that these novel image-guided (IG) approaches are~     clinically feasible and could be applied more broadly in prostate cancer therapy.~   "
202341|NCT00913926|"~     Aim of this NIS is to obtain further information on efficacy, tolerability, and acceptance of~     Wellnara in a large user population under the conditions of routine medical practice.~     Furthermore, any adverse drug reactions will be recorded in a large user population under the~     conditions of medical routine. To investigate the efficacy of Wellnara, patients will fill in~     a questionnaire, the so-called Menopause Rating Scale (MRS II). Further, the effects of~     treatment on skin and hair will be evaluated by the investigator. Patients will assess~     treatment effects on their sexual life. Safety parameters include monitoring of vaginal~     bleeding, measurement of blood pressure and body weight, and - as far as routinely used in~     the practice - calculation of waist-hip-ratio. Any relevant additional information related to~     adverse drug reactions will also be documented.~   "
202342|NCT00913913|"~     Immune therapies, such as a IL-2, for metastatic renal cell carcinoma (mRCC) are designed to~     mobilize immune effector cells that recognize and destroy cancer. The investigators have~     recently observed a 50% objective response rate (16% CR) in mRCC patients treated with~     autologous tumor lysate -dendritic cell (DC)-vaccine, IL-2 and interferon alfa (IFN). New~     agents inhibiting vascular endothelial growth factor (VEGF) pathways have demonstrated~     significant benefit in mRCC patients as well, but rarely induce CRs. High blood VEGF is~     associated with poor response to IL-2 and can cause tumor specific immune dysregulation. To~     test whether complementary mechanisms of immune activation and disruption of regulatory~     pathways enhance outcome the investigators plan to treat 24 mRCC patients in a phase II trial~     using bevacizumab, DC vaccine, IL-2, and IFN. Observations from this project will be used in~     the development of novel cancer therapies which, if successful, will decrease the burden of~     cancer on the public.~      The investigators propose to determine 1) the objective clinical response rate to treatment~     and progression free survival, 2) the clinical and autoimmune related toxicity profile of~     therapy, and 3) the treatment related tumor-specific immune response and the relationship of~     tumor-specific immune response and objective clinical response.~   "
202343|NCT00913900|"~     Peripheral artery disease (PAD) due to leg artery blockages can result in painful leg~     muscles, skin ulcers and infection due to poor blood flow. In severe forms, the only~     treatment may be amputation. Adult stem cells injected into affected legs may cause new blood~     vessel formation and improve blood flow. The purpose of this study is to determine the~     feasibility and safety of injecting adult stem cells into the leg muscles of patients with~     severe PAD, in an attempt to improve blood flow.~   "
202344|NCT00913887|"~     To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets~     under non-fasting conditions.~   "
202345|NCT00913874|"~     To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release~     tablets under fasting conditions.~   "
202347|NCT00913848|"~     To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release~     tablets under fed conditions.~   "
202348|NCT00913835|"~     The purpose of this study is to determine if participants with platinum-refractory or~     platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab~     (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal~     Doxorubicin alone.~   "
202349|NCT00913822|"~     To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.~   "
202350|NCT00913809|"~     To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to~     Merrell Dow's 100 mg Norpramin tablets.~   "
202351|NCT00913796|"~     Acidosis (accumulation of acid in the body) may be an underrecognized problem in patients~     after renal transplantation. It may have consequences on physical performance due to negative~     effects on bone and muscle metabolism.~      Therefore, the purpose of this study is~        1. to determine the status of physical capacity and bone structure in renal transplant~          patients with metabolic acidosis~        2. to study the effect of substituting base equivalents (citrate) on acid/base status of~          renal transplant patients with acidosis~        3. to compare the status of physical capacity and bone structure in renal transplant~          patients with metabolic acidosis before and after substitution with citrate~   "
202352|NCT00913783|"~     To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg~     Clomipramine Hydrochloride capsules under fasted conditions.~   "
202353|NCT00913770|"~     Patients with heroin and prescription opioid dependence are at increased risk for adverse~     health consequences and often utilize the Emergency Department (ED) as their source of~     medical care. Screening, brief intervention and referral to treatment has been effective in~     decreasing high risk behaviors such as alcohol and tobacco use, and unsafe sexual practices.~     The data on the effectiveness of brief interventions with opioid dependence is limited. This~     prospective, randomized controlled trial of opioid dependent subjects (N=360) will compare~     two models of brief intervention with a control condition. ED patients with opioid dependence~     will be randomized to either: (1)Screening, Brief Intervention with a Facilitated Referral to~     Treatment (SBIRT); (2) Screening, Brief Intervention with ED initiated Buprenorphine~     Treatment (SBI+Bup); or (3) standard care (SC) which includes a handout detailing substance~     abuse treatment centers in the area. The primary outcome will be self-reported engagement in~     formal substance abuse treatment at 30 days, verified by contact with the treatment program.~     Other outcomes measured at 30 days, 2, 6 and 12 months include changes in opioid use~     (self-report and urine toxicology analysis), HIV risk behaviors, and health care service~     utilization. The three interventions will also be compared on their cost-effectiveness. We~     will test the hypotheses that SBI+Bup will be superior to SBIRT and SC, and SBIRT will be~     superior to SC in (1)increasing the proportion of patients engaged in formal substance abuse~     treatment at 30 days; (2) reducing illicit opioid use; (3) reducing HIV risk behaviors; and~     (4) reducing health care service utilization. In addition, we hypothesize that the societal~     costs of SBI+Bup, per number of days of opioid abstinence, will be cost effective relative to~     SBIRT or SC; and that SBIRT will be cost effective relative to SC. Data analyses will be~     conducted on the intention to treat sample of randomized patients. This study, conducted by a~     research team with extensive experience evaluating brief interventions and treatments for~     opioid dependence, will be unique in its: (1) comparison of two models of brief intervention~     with standard care; (2) inclusion of an ED initiated treatment arm; (3) use of manual-guided~     interventions with systematic assessment of adherence and competence; and (4)collection of~     detailed cost data to help guide future healthcare policy.~   "
202354|NCT00913757|"~     Background:~        -  Liver cancer is the third most deadly and fifth most common cancer worldwide.~          Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has~          grown more prevalent in the United States.~        -  More information is needed about the causes and effects of liver cancer, and further~          research into individuals who are at high risk for developing liver cancer is needed for~          early diagnosis and prevention.~      Objectives:~        -  To identify genetic factors that may help to explain the aggressiveness of liver cancer.~        -  To determine if HCC biomarkers exist in blood, urine, and tissue samples.~      Eligibility:~        -  Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high~          risk for developing HCC because of fatty liver disease (alcohol-related or~          non-alcohol-related) or chronic hepatitis B or C.~        -  Participants will reside in Baltimore City and the surrounding areas.~      Design:~        -  Participants will complete a questionnaire and provide blood and urine samples for~          testing:~        -  The questionnaire will include questions about individual and family medical history,~          tobacco use, and exposure to known factors for liver cancer.~        -  Blood and urine samples will be collected from all participants after the questionnaire.~        -  Tumor tissue and healthy tissue will be collected from selected participants if they~          undergo surgery for their cancer or disease.~        -  No specific treatment will be offered as part of this protocol, but participants have~          the option to be treated under different protocols.~   "
202355|NCT00913744|"~     This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in~     subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is~     believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic~     vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where~     this adhesion may be causally associated with worse prognosis).~   "
202356|NCT00913731|"~     The purpose of this project is to test the reliability of the FAST-O Rating Scale in patients~     at acute wards or psychiatric intensive care units.~   "
202357|NCT00913718|"~     To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine~     Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.~   "
202358|NCT00913705|"~     Open-label multicenter randomized Phase III trial.~   "
202359|NCT00913692|"~     Background:~        -  A cold sore is usually a blistering rash on or near the lips, caused by infection with~          herpes simplex virus. After the first infection, the virus goes into a dormant~          (inactive) state, but it can continue to cause cold sores.~        -  Most people with the herpes simplex virus have a few episodes of cold sores per year.~          However, some individuals may have many recurrent episodes that are uncomfortable and~          may cause embarrassment. Researchers are attempting to find treatments that can decrease~          the number of cold sore episodes for people who have six or more episodes per year.~        -  Glutamine is a molecule called an amino acid and is one of the components that make up~          proteins in the body. Clinical studies using glutamine have addressed the potential of~          glutamine to improve immune function and to heal damaged tissue or to help healing.~      Objectives:~      - To find out if the dietary supplement glutamine can help individuals with frequently~     recurring (more than six episodes per year) cold sores.~      Eligibility:~        -  Patients between 18 and 65 years of age who have a history of having six or more cold~          sore episodes per year, and have not received certain kinds of drug treatment for the~          cold sores within 1 month of beginning the study.~        -  Patients who have two or more episodes of cold sores caused by the herpes simplex virus~          will be eligible for treatment as part of this study.~      Design:~        -  Initial clinical visit for a physical examination and medical history, at which blood~          samples will be drawn for testing.~        -  Eligible participants will undergo a 4-month screening period. Patients who develop~          sores during this period will visit the NIH to have the sore examined to determine if it~          is caused by the herpes virus. Patients who have two or more episodes of cold sores~          caused by the herpes simplex virus will be eligible for treatment.~        -  Patients who are eligible for treatment will provide an initial blood sample and will~          receive randomized doses of either glutamine or glycine (another amino acid), which must~          be taken on a regular schedule twice daily, mixed with either liquid or soft food.~          Patients who develop sores during this period will visit the NIH to have the sore~          examined to determine if it is caused by the herpes virus. Blood, urine, and saliva~          specimens will be collected each month during the treatment period. A 2-week washout~          period will occur between the 2 treatment periods when no doses of glutamine or glycine~          will be taken.~        -  Patients will then undergo a second 5-month treatment period with either glutamine or~          glycine (whichever was not given in the first part of the study), taken in the same~          manner as before. Patients who develop sores during this period will visit the NIH to~          have the sore examined to determine if it is caused by the herpes virus.~        -  After the second treatment, patients will remain in touch with researchers for 1 month~          to note any changes.~   "
207361|NCT00846950|"~     The purpose of this study is to determine whether histamine is involved in memory and~     specific processes in human cognition.~   "
202360|NCT00913679|"~     The purpose of the study is to compare two different surgical techniques in hip resurfacing~     arthroplasty (RHA), comparing bloodflow and metabolism in the femoral head, as well as~     implant migration, periprosthetic bone mineral density, gait function and patient recovery.~   "
202361|NCT00913666|"~     This study will look at differences in bioanalytical measures among different groups of MS~     patients and Healthy Volunteers, when administered interferon beta-1a.~   "
202362|NCT00913653|"~     This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart~     failure.~   "
202363|NCT00913640|"~     The investigators tested whether prospective memory is impaired in individuals with~     Parkinson's Disease compared to controls using reliable and validated experimental measures.~     Also, the investigators assessed the impact of Parkinson's medication on prospective memory~     performance in PD to better estimate prospective memory function in PD patients' everyday~     (chronically treated) life.~   "
202364|NCT00913627|"~     The purpose of this study is to assess the efficacy and safety of a single dose of an~     ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern~     that the manufacturing process may affect the performance characteristics of the selected~     prototype. Therefore, two formulations of this prototype manufactured by two different~     processes, [roller compaction] and [wet granulation] will be included in this study. The~     preferred prototype manufactured by two different methods will be compared to placebo and~     each other. This study will also characterize the pharmacokinetic/pharmacodynamic~     relationship with these formulations.~   "
202365|NCT00913614|"~     Given the potential age-related differences in safety, tolerability, pharmacokinetics, and~     differences in sleep architecture in young children versus adolescent versus adult, studies~     to identify the appropriate drug and dosage for children of all ages are essential in~     addressing this health problem that impacts the child and their family. The objective of this~     study is to evaluate the safety, pharmacokinetics and preliminary efficacy of eplivanserin.~      Primary objective: to assess the safety and tolerability after administration of single~     ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various~     origins.~      To assess the pharmacokinetics of eplivanserin (and active metabolite: SR141342) after~     administration of single ascending oral doses of eplivanserin to children aged 6-17 years~     with insomnia of various origins.~      Secondary objective: to assess the effect of single ascending oral doses of eplivanserin on~     global sleep parameters and sleep architecture measured via polysomnography recordings in~     children aged 6-17 years old with insomnia of various origins.~   "
202366|NCT00913601|"~     Faecal incontinence is a devastating condition causing psychological stress, affecting daily~     living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult~     population. The magnitude of the problem is probably underestimated, because most patients~     don't discuss this affliction with their general practitioner. A new treatment, sacral nerve~     stimulation (SNS), has over the last decade given hope to these patients. The treatment is~     divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit~     from treatment with permanent sacral nerve stimulation. Second if the patient benefit from~     the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal~     incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and~     the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral~     nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve~     stimulation can produce better fecal continence results than standard unilateral stimulation,~     through a double blind, randomized crossover study.~   "
202367|NCT00913588|"~     To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine~     Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions.~   "
202368|NCT00913575|"~     Background:~      Osteoarthritis (OA) is a common degenerative condition of large weight-bearing joints, such~     as the hip and knee, as well as small hand joints. Current interventions in patients with OA~     are limited to symptomatic pain relief and later with total joint replacement (TJR). While~     TJR improves function and pain, it does not fully restore function in most individuals. A key~     factor of functional outcome is probably conditioning before and after TJR surgery. However,~     this has not been studied conclusively in patients undergoing TKR surgery.~      Objective:~        1. Primary endpoint: To study the effect of a pre-surgery neuromuscular PT compared to an~          attention control program on lower extremity function measured by the Chair stands test~          (observed function) and the KOOS score (reported function).~        2. Secondary endpoints will be muscle strength, walking time and mobility.~      Hypothesis:~      The investigators hypothesize that patients undergoing pre-surgery PT will be significantly~     quicker in performing the chair stands test and report a significant improvement in the KOOS~     at 3 months after surgery compared to controls.~      Methods:~      80 patients from a waiting list for unilateral TKR will be randomized to neuromuscular PT or~     an attention control group intervention in a single-blinded randomized controlled trial.~     Assessments will be at baseline, at 3 months after surgery and at 12 months after surgery.~      Intervention:~      The neuromuscular PT group will receive a minimum of 8 and a maximum of 24 training sessions;~     all patients, including the control group, will receive 4 sessions of the Knee School.~      Significance:~      Given the demographic change with an increase in the older segment of the population there~     will be a rise in the absolute number of TKRs. It is therefore warranted to study pre-surgery~     neuromuscular PT to help patients get the most out of their joint replacement.~   "
202369|NCT00913562|"~     Endothelial dysfunction can be seen in a variety of vascular related ocular diseases such as~     glaucoma or diabetic retinopathy. There is accumulating evidence now that statins may at~     least partially improve endothelial function in several vascular beds, an effect that is~     probably independent of the lipid lowering effects of the statins.~      Consequently, the current study seeks to investigate whether administration of 10 mg~     rosuvastatin by mouth (p.o.) for 12 weeks can improve the endothelial function in patients~     with glaucoma and diabetic retinopathy. For this purpose, flow mediated vasodilatation of the~     brachial artery and flicker induced vasodilatation of retinal vessels will be measured at~     baseline, after 6 and 12 weeks of treatment with rosuvastatin.~   "
202370|NCT00913549|"~     To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg~     tablets.~   "
202407|NCT00913068|"~     The researchers propose to investigate a relatively new anesthetic procedure, in order to~     maximize patient comfort and minimize the use of narcotics after a radical prostatectomy.~   "
202408|NCT00913055|"~     To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and~     non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of~     treatment.~   "
202580|NCT00910780|"~     This project aims to identify whether therapeutic substitution of aripiprazole for~     risperidone or olanzapine, combined with standard nutrition intervention, will impact the~     metabolic changes associated with antipsychotic treatment in children and adolescents.~   "
202371|NCT00913536|"~     This study is designed to investigate whether daily images of the pelvis and bladder using a~     device called a cone beam CT scanner will help to increase the accuracy of radiotherapy~     treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit. The results~     of the study may allow patients in the future who are undergoing radiotherapy treatment for~     bladder cancer to 1) have more accurately directed treatment, 2) have higher doses of~     radiation delivered to the tumour while keeping doses to the surrounding normal tissues as~     low as possible. This may allow eradication of the cancer while minimizing side effects of~     treatment.~      This study consists of two phases: Phase A and Phase B. In Phase A, images were collected and~     analyzed and it was confirmed that it was useful to use the cone beam machine for daily Cone~     Beam CT Bladder (Phase B)treatment adjustments. In phase B, we hope to be able to use cone~     beam CT scans to more accurately direct the radiotherapy treatments on a daily basis.~   "
202372|NCT00913523|"~     Subjects will be using investigational or control tampons during their menstrual period but~     these tampons are not intended to prevent, treat or diagnose an infection or other disease~     condition. A total 450 women will participate in this study at two study sites. Subjects will~     be randomly assigned to one of three tampon groups. The first group will test an experimental~     test tampon containing glycerol monolaurate (GML) on the cover. The second group will test an~     identical tampon, but without GML. The third group will not be issued study tampons but will~     be instructed to use their normal tampon brand. This study is intended to determine whether~     the effects of GML observed in the laboratory can be demonstrated in healthy menstruating~     women.~   "
202373|NCT00913510|"~     The aims of this prospective, randomized study are:~        -  To assess the effect of clean intermittent catheterization (CIC)~        -  To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia~          and incontinence) when using CIC in combination with anticholinergic drugs~        -  To identify at what volume of Postvoid Residual (PVR) urine, starting CIC improves~          bladder control and QoL~        -  To increase the evidence of CIC, and support clinical guidelines of bladder management~          in MS patients~   "
202374|NCT00913497|"~     To determine whether insulin glulisine decreases the breakfast post prandial glycemic~     excursion in comparison to insulin aspart.~   "
202375|NCT00913484|"~     The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy~     and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse~     in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on~     buprenorphine/naloxone combination.~   "
202376|NCT00913471|"~     The investigators propose to compare plasma protein profiles for SCI patients with/without~     chronic neuropathic pain in order identify biomarker(s) that are associated with this medical~     condition. Secondly, the investigators propose to identify a temporal relationship to initial~     SCI at which these biomarkers manifest.~      Our working hypothesis is that sustained alterations in specific inflammatory molecules are~     associated with chronic neuropathic pain following SCI, and that their plasma levels can~     serve as biomarkers to identify patients at risk for the development of neuropathic pain.~      Additionally the investigators are collecting skin tissue biopsy samples from patients~     following acute and chronic spinal cord injury to create vector-free human iPS cells from~     fibroblasts by direct delivery of reprogramming proteins.~   "
202377|NCT00913458|"~     Study to evaluate whether there is sustained remission and productivity in subjects with~     early rheumatoid arthritis started on etanercept plus methotrexate treatment.~   "
202378|NCT00913445|"~     The purpose of this trial is to compare two techniques of wound closure in open~     appendicectomies in adult patients: continuous, absorbable, intradermal suture and~     interrupted, non-absorbable sutures.~   "
202379|NCT00913432|"~     A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib~     at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active~     rheumatoid arthritis refractory to standard treatments.~   "
202380|NCT00913419|"~     To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.~   "
202381|NCT00913406|"~     Study to determine if the addition of lutein to infant formula supports healthy growth and~     development in healthy full term infants.~   "
202382|NCT00913393|"~     The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or~     diabetic nephropathy.~   "
202383|NCT00913380|"~     The purpose of this study is to determine whether low-dose CT is not inferior to~     standard-dose CT in the rate of unnecessary appendectomy.~   "
202384|NCT00913367|"~     The purpose of this study is to compare the efficacy of Amaryl®M 1/500 mg twice daily versus~     Amaryl® 4 mg both in combination with Lantus® once-daily regimen in type 2 Diabetes Mellitus~     patients with inadequate glycemic control.~   "
202385|NCT00913354|"~     During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy~     rate. This study aims to compare IVF pregnancy between two groups of patients that received~     either acupuncture or sham acupuncture (placebo)around embryo transfer~   "
202386|NCT00913341|"~     To demonstrate the relative bioavailability of Alprazolam tablets, 1 mg.~   "
202387|NCT00913328|"~     Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the~     effect of inhaled corticosteroids.~      Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled~     methacholine in patients with mild to moderate persistent asthma treated with a stable dose~     of inhaled corticosteroids.~   "
202388|NCT00913315|"~     The purpose of this study is to determine whether tamsulosin and tolterodine are effective in~     the treatment of men with lower urinary tract symptoms and chronic prostatitis/chronic pelvic~     pain syndrome.~   "
202389|NCT00913302|"~     To test the effects of a cardiovascular training compared to attention control in a group of~     AS-patients participating in classic spinal mobility exercise groups (randomized controlled~     trial)~   "
202390|NCT00913289|"~     Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be~     useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem~     cells compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will~     receive autologous adipose tissue derived stromal cells which include such mesenchymal stem~     cells.~   "
207565|NCT00844272|"~     Study objective: Feasibility and efficacy of a standardised psychosocial intervention~     (psychoeducation) in substituted opioid dependent patients~   "
202391|NCT00913276|"~     The gap between the number of candidates for orthotopic liver transplantation and the~     availability of suitable liver grafts has led to a rise in deaths on most waiting lists.~     Strategies applied in many centers to minimize this deficit include living donation or split~     of a cadaveric organ for two recipients, domino transplantation, and the use of so-called~     expanded criteria donors. Alternatively, conditioning of an organ would also allow~     protec-tion of the liver upon ischemia-reperfusion injury, possibly decreasing postoperative~     liver function and im-proving clinical outcome. The technique of conditioning with the~     volatile anesthetic sevoflurane is an easily applicable procedure which could be performed in~     any center worldwide.~      Data and experience with sevoflurane attenuating ischemic-reperfusion injury in liver~     resection lead to the hypothesis of a beneficial effect of volatile anesthetics in liver~     transplantation. In this randomized controlled trial, patients will be randomly assigned to~     liver transplantation with propofol anesthesia (propofol group) or sevoflurane conditioning~     with the volatile anesthetic (sevoflurane group). Primary endpoint is postoperative peak of~     the transaminase (AST), secondary endpoints are complications, primary liver graft function,~     ICU and hospital stay. We hypothesis that patients with conditioning have an attenuated~     increase of transaminases as well as a better outcome.~   "
202392|NCT00913263|"~     The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients~     with localized prostate cancer. Primary efficacy variable was the proportion of patients~     showing PSA nadir. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with~     localized prostate cancer were injected once with a ready made paste including 600 mg~     2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour was~     localized. The patient was monitored for prostate-specific antigen (PSA) for maximum 6 months~     or to progression within this time period. The primary endpoint showed interesting results~     with high success rate (83%), i.e. proportion of patients (Responders) that reached plasma~     PSA nadir.~   "
202393|NCT00913250|"~     Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of~     Avonex.~   "
202394|NCT00913237|"~     To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.~   "
202395|NCT00913224|"~     To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated~     tablets.~   "
202396|NCT00913211|"~     Paralysis following stroke stems not only from the loss of neurons killed by the stroke but~     also from the loss of neurons lying dormant in the stroke hemisphere. One of the reasons~     viable neurons become dormant (down-regulated) is because of excessive interhemispheric~     inhibition imposed on them from the nonstroke hemisphere. The challenge in~     neurorehabilitation is to restore excitability and voluntary control of these down-regulated~     neurons in the stroke hemisphere. Suppression of the source of this excessive~     interhemispheric inhibition can be achieved with the noninvasive method called repetitive~     transcranial magnetic stimulation (rTMS). It has been shown in healthy subjects that the~     known depressant effects of low-frequency rTMS can be increased and prolonged by preceding it~     with 6-Hz priming stimulation. In a recent safety study, we showed that one treatment of 6-Hz~     primed low-frequency rTMS applied to the nonstroke hemisphere is safe. It is now important to~     evaluate a series of these treatments and whether their efficacy can be enhanced by combining~     the rTMS with motor learning training. The specific aims of this study are to determine the~     efficacy, mechanism, and safety of a series of 5 treatments of 6-Hz primed low-frequency rTMS~     applied to nonstroke hemisphere and combined with motor learning training to promote recovery~     of the paretic hand. Forty subjects with stroke will be randomly assigned to one of four~     treatment groups. The rTMS/only group will receive 20 min. of rTMS per day. The Track/only~     group will receive 20 min. of finger tracking training per day. The rTMS/combined group will~     receive alternating days of the rTMS and Track treatments. The rTMS/sham group will receive~     20 min. of rTMS using a sham electrode each day. The hypotheses are: 1) the rTMS/combined~     group will show the greatest improvements in hand function, 2) the rTMS/combined group will~     show the greatest improvements in cortical excitability using paired-pulse TMS testing and in~     brain reorganization using fMRI, and 3) the rTMS treatment will be safe. The proposed~     research is important because it addresses the greatest cause of long-term disability in~     society, hemiparesis following stroke, and it is innovative because it applies a technique~     never used before, 6-Hz primed low-frequency rTMS combined with motor learning training. The~     potential impact of this research is a radical change to rehabilitation that accomplishes a~     higher quality of life in stroke.~   "
202397|NCT00913198|"~     The main objective of this study is to assess the biological activity of CP-4126 in patients~     with advanced pancreatic cancer. In addition, the correlation between hENT1 (human~     equilibrative nucleoside transporter 1) and overall survival will be studied.~   "
202398|NCT00913185|"~     The purpose of this study is to compare the effectiveness of two over the counter acne~     products in subjects with moderate severity acne vulgaris. The two products being compared in~     this study are Acne Free Severe Acne Line manufactured by University Medical Products, and~     Proactiv® manufactured by Guthy-Renker.~   "
202399|NCT00913172|"~     Evidences for policy making and decision related to the cost of delivering tuberculosis (TB)~     control is lacking in Ethiopia. The investigators aimed to determine the cost and~     cost-effectiveness of involving health extension workers (HEWs) in TB treatment under the~     community-based initiative in Ethiopia.~   "
202400|NCT00913159|"~     The older lithotripter, HM3, has over 90% stone-free rate in most studies. However, it's less~     transportable than the new model, F2. There are no prospective trials performed to make a~     valid comparison between these 2 lithotripters in terms of efficacy of stone fragmentation~     and clinical outcomes.~   "
202401|NCT00913146|"~     The investigators performed a prospective study, in order to assess the feasibility and~     safety of restricting antimalarials to rapid diagnostic test (RDT)-confirmed cases in~     children aged 5 to 15 years-old~   "
202402|NCT00913133|"~     The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin~     for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.~   "
202403|NCT00913120|"~     The purpose of this study is to examine the superiority of YM150 to the placebo and to~     evaluate the dose-dependent response of YM150 in patients undergoing elective total hip~     replacement surgery.~   "
202404|NCT00913107|"~     The purpose of this study was to determine the efficacy and safety of lamotrigine in patients~     with trigeminal neuralgia (TGN).~   "
202405|NCT00913094|"~     To determine whether impedance cardiography (ICG) parameters can predict favorable or~     unfavorable blood pressure (BP) response and time to BP control prior to initiation or~     intensification of specific antihypertensive drug classes and drug combinations, independent~     of initial BP levels.~   "
202406|NCT00913081|"~     Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective~     drug to raise HDL, or the good cholesterol. The use of niacin has been limited because of a~     peculiar adverse effect referred to as flushing', which consists of redness, warmth,~     tingling and burning. A recent animal study suggests that flavonoids may prevent flushing due~     to niacin better than drugs like aspirin. The ANTI-FLUSH study is being done to assess~     whether a presently available dietary supplement known as quercetin, which is a flavonoid,~     can reduce the flushing that occurs with niacin. We will also assess whether using quercetin~     to prevent flushing from niacin, can improve how niacin lowers cholesterol.~   "
202409|NCT00913042|"~     Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost~     exclusively by blood cultures. The reasons for this low documentation are likely multiple:~     (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in~     the blood may be low and consequently undetectable by conventional blood cultures.~      The primary objective of the study is to assess new blood culture procedures and technics, in~     order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.~   "
202410|NCT00913029|"~     Prospective, unmasked, randomized evaluation of the iStent in patients with primary~     open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2)~     medication.~   "
202411|NCT00913016|"~     To compare the overall QoL (Quality of Life) using Trial Outcome index (TOI) of FACT-B~     questionnaire for 3 years from baseline.~   "
202412|NCT00913003|"~     The aim of this study is to determine if perioperative systemic lidocaine administration will~     decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In~     addition, patients receiving systemic lidocaine will have a lower incidence of~     post-mastectomy pain syndrome.~      This study will have 2 groups. Participants will be randomized into one of each group. The~     first group will be administered the drug lidocaine prior to surgery and the second group~     Group B will be administered saline (salt water). This is a blinded study which means the~     participant will not know which group they have been assigned. The subjects participation~     will last 12 months (surveys post operatively).~   "
202413|NCT00912990|"~     The investigators' primary specific aims are to demonstrate that:~        1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be~          successfully intubated when deeply sedated, without the use of muscle relaxants using~          the Shikani Optical Stylet.~        2. Shikani intubation of pediatric patients is equally effective in children that are~          deeply sedated or paralyzed as evidenced by a non-significant difference in:~             -  Time to intubation (defined as no more than a 30 second time difference between the~               two groups);~             -  Incidence of adverse events.~   "
202414|NCT00912977|"~     Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted~     movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of~     these movements can range from subtle to extremely debilitating and may or may not interfere~     with normal activities such as putting on a coat or brushing ones teeth. The purpose of this~     study is to demonstrate the validity and reliability of objectively measuring dyskinesia with~     a forceplate.~   "
202415|NCT00912964|"~     The study is intended to test efficacy, safety and tolerability of two doses of once daily~     (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.~   "
202416|NCT00912938|"~     to evaluate whether bone marker can provide the valuable predictor of skeletal complications~     and whether regular assessing of NTX(N-telopeptide of type I collagen) and osteocalcin can be~     useful in advanced breast cancer patients with bone metastasis receiving zoledronic acid.~   "
202417|NCT00912925|"~     This study is being conducted to demonstrate the safety and clinical efficacy of Aldurazyme~     treatment in MPS I patients~   "
202418|NCT00912912|"~     The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248)~     can control the disease in patients with germ cell tumors that are resistant to earlier~     treatment.~   "
202419|NCT00912899|"~     This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety &~     tolerability of noscapine HCl in patients with advanced multiple myeloma~   "
202420|NCT00912886|"~     The steroid pregnenolone sulfate (PREGS) may be one of the factors responsible for the memory~     decline related to normal aging or associated with Alzheimer's disease (AD). The purpose of~     this study is to determine whether plasma levels of PREGS are decreased patients with at mild~     to moderate AD compared with AD-free control subjects matched for gender and age and to see~     whether they are inversely correlated with the severity of memory deficits in AD patients.~     The hypothesis is that blood levels of PREGS are decreased with advanced age and with the~     stage of AD that would be positively correlated with memory deficits. Therefore PREGS could~     be considered as an early marker of the memory deficits in AD.~   "
202421|NCT00912873|"~     This is a research study to determine if the concentration of local anesthetic through a~     catheter next to the nerves that go to the hip that is undergoing surgery, affects muscle~     strength and sense of touch experienced after surgery. This study is looking at the varying~     concentrations of local anesthetic placed through the catheter.~   "
202422|NCT00912860|"~     To evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given~     to interferon beta naive patients with relapsing/remitting multiple sclerosis.~   "
202423|NCT00912847|"~     The purpose of this study is:~        1. To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC)~          screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV~          carriers between age 40 and 70 years);~        2. To establish the cost-effectiveness of the screening tests;~        3. To compare tumor sizes, resection rates, and survival rates up to 18 months between~          those who were screened by HS-AFP those of a historical control group that was not~          screened.~   "
202424|NCT00912834|"~     To understand the urine analysis of athletes~   "
202425|NCT00912821|"~     Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage~     renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment~     is lacking, most patients begin their PD with four 2 L exchanges per day. However, many~     patients have their residual renal function at the initiation of PD, an 8 L dialysate per day~     will enhance the toxicity of bioincompatible dialysate and increase the economic burden~     compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective,~     randomized, controlled, multi-center clinical study. The patients initiation of PD treatment~     within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L~     of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes~     such as mortality, complications and life quality between the two groups will be~     investigated.~   "
202465|NCT00912301|"~     The study hypothesis is that the naturally occurring bile acid, chenodeoxycholic acid,~     induces acceleration of colonic transit in health and in patients with~     constipation-predominant Irritable Bowel Syndrome (IBS-C).~   "
202426|NCT00912808|"~     The purpose of this study is to find out if a medication that increases levels of a brain~     chemical called acetylcholine will improve balance and reduce falls in patients with~     parkinson's disease who have the problem of very poor balance and are frequently falling or~     nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's~     dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.~   "
202427|NCT00912795|"~     The purpose of this study is to develop and test a text messaging-based smoking cessation~     program for adults who are currently smoking and want to quit, living in Turkey.~   "
202428|NCT00912782|"~     Patients requiring hemodialysis following kidney failure need a form of dialysis vascular~     access in order to undergo the dialysis procedure. Dialysis vascular access dysfunction is an~     enormous clinical problem. While the best form of vascular access is the arteriovenous~     fistula (AVF), its primary problem is early, aggressive cellular ingrowth that leads to poor~     maturation of the vessel, preventing its use for dialysis. Strategies to prevent AVF failure~     are needed.~      Vitamin D is a hormone present in all human bodies and is important for good bone formation~     and immune function. There is new information that links vitamin D to the function of our~     veins and arteries, which are used in the creation of an arteriovenous fistulae. Our bodies~     can make vitamin D and can also get vitamin D from our diet. However, a majority of patients~     with chronic kidney disease and end-stage renal disease (ESRD) have low vitamin D levels~     (vitamin D deficiency). There are several benefits to correcting low vitamin D levels,~     however, it is not know whether correcting low vitamin D in the body will lead to better~     function of the vein and artery used for arteriovenous fistulae creation. The main goal of~     this pilot study is to examine the role of vitamin D supplementation on AVF maturation and~     useability for dialysis. Study results will be used to develop larger studies to examine the~     specific effect that vitamin D supplementation has on the vessels used for AVF creation and~     whether vitamin D promotes AVF maturation.~   "
202429|NCT00912769|"~     To compare muscle torque recovery between patients under subvastus approach and those under~     midvastus approach after total knee replacement~   "
202430|NCT00912756|"~     Recently, Nanto et al. reported that cilostazol effectively prevented restenosis in a~     retrospective analysis of 121 femoropopliteal artery lesions in percutaneous transluminal~     angioplasty (PTA) patients who had undergone PTA. In a prospective 3-year follow-up study in~     127 patients with similar diseases, the patency rate was significantly higher in the~     cilostazol group than in the ticlopidine group. It was also found that cilostazol markedly~     inhibited restenosis during the first 1-year period following endovascular therapy when~     restenosis is most frequently observed. In addition, there have been sporadic reports that~     cilostazol was effective in preventing post-stenting restenosis in the coronary artery area.~      Based on these results, this multicenter study is going to be conducted to prospectively~     evaluate the usefulness of cilostazol in lower limb endovascular therapy.~   "
202431|NCT00912743|"~     This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively~     and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to~     determine whether olaparib will have a beneficial effect on the patient's cancer by causing a~     response and increasing the time it takes for the cancer to progress.~   "
202432|NCT00912730|"~     This is a single-institution pilot study seeking preliminary evidence of the usefulness of~     mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma.~   "
202433|NCT00912717|"~     After informed consent, participants will be asked to complete a medical/family history~     questionnaire and provide a blood sample. Some participants may also be asked to provide a~     urine sample. Individuals undergoing procedures that require collection of biological samples~     for clinical purposes may have these samples saved for research purposes. Participants will~     also be asked for their permission for study investigators to access medical records and/or~     recontact them for updates to their medical and family histories. Data and biospecimens will~     be stored for potential future research projects.~   "
202434|NCT00912704|"~     End-stage renal disease (ESRD) is a healthy, social and economic threat worldwide. In the~     past ten years, the incidence and prevalence of ESRD patients have tremendously increased,~     ranking at the top in the world. The reasons for such high incidence and prevalence are~     multifactor. Early diagnosis and closed monitor of the patients with chronic kidney disease~     (CKD) may be beneficial, but not confirmed yet.The advising mechanisms for non-doing or~     withdraw long-term dialysis. All these studies will be performed in a multicentered project.~     Three medical centers in which CKD researches have been conducted for many years will provide~     a large cohort and share the data collected from their own hospitals. We expect that the~     results will provide an excellent guideline for CKD care, achieve cost-effectiveness of~     dialysis therapy and better life quality of ESRD patients.~   "
202435|NCT00912691|"~     The purpose of this study is to determine whether CM-AT is effective in treating the core~     symptoms of autism.~   "
202436|NCT00912678|"~     Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the~     decreased injury threshold of older grafts may limit the benefits of transplantation in these~     patients. To compare favourable effects between low dose tacrolimus (LD-Tac) and~     mycophenolate-mofetil (MMF) in this patient population the investigators conducted a one year~     prospective multicenter randomized controlled trial. 90 kidney transplant recipients > 65~     years with cadaveric grafts (> 65 years) from 5 centers were enrolled and received baseline~     immunosuppression with daclizumab induction (1 mg/kg) at day one and day 14, LD-Tac (trough~     level 5-8 µg/ml), MMF (1-2 g/d) and steroids. After three months, patients were centrally~     randomized either to MMF (1-2 g/d) and steroids (23 patients) or to LD-Tac and steroids.~     Follow-up visits were performed every 4 weeks up to one year. Protocol biopsies were~     performed after one year. The investigators' primary hypothesis is that the biopsy proven~     rejection rate in the MMF group is not significantly different compared to the LD-Tac group~     after one year. The investigators' secondary hypothesis is that graft function in the MMF~     group (reflected by the glomerular filtration rate and protocol biopsy result) is superior to~     the graft function in the LD-Tac group.~   "
202466|NCT00912288|"~     No Dimebon clinical data exist yet in patients with disease that has advanced to the~     moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon~     in patients with moderate-to-severe AD who are receiving existing background therapy with~     memantine.~   "
202437|NCT00912665|"~     Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance~     to changes in perfusion pressure. In the eye, several studies have reported that retinal~     blood flow is autoregulated over a wide range of ocular perfusion pressures. In the optic~     nerve head only few data are available. Large scale studies have shown that reduced ocular~     perfusion pressure is an important risk factor for the prevalence, the incidence and the~     progression of primary open angle glaucoma.~      Former studies that investigated ocular blood flow autoregulation only measured choroidal~     blood flow. For the optic nerve head only few data are available, although it seems likely~     that it underlies similar autoregulatory mechanisms.~      The primary goal of the present study is to gain more insight into these phenomena in humans.~      The present study aims to investigate the pressure/flow relationship as a measure for optic~     nerve head autoregulation during combined changes of intraocular pressure and arterial~     pressure. Intraocular pressure will be increased by the use of a suction cup technique, mean~     arterial pressure will be increased by squatting. During the whole procedure, optic nerve~     head blood flow will be measured continuously.~   "
202438|NCT00912652|"~     More and more Americans are becoming overweight. The rates of overweight are especially high~     in rural areas of the country. Until now, there has been little access to weight management~     programs in rural areas. This study will examine ways to help individuals from rural counties~     to manage weight and improve fitness. To do this, three doses of lifestyle treatment (Low,~     Moderate and High)will be compared to an education control condition. Our principal~     hypothesis is that both the Moderate and High conditions will have greater weight loss at two~     years than either the Low or Control conditions.~   "
202439|NCT00912639|"~     The purpose of this study is to evaluate the response rate in patients with taxane-pretreated~     recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).~   "
202440|NCT00912626|"~     The goal of this study is to determine if there is a correlation between an efficacious~     family environment and sibling behavior in families with children who are critically ill.~   "
202441|NCT00912613|"~     The incidence of PTSD post ICU varies from unit to unit, however a significant number of~     patients have been shown to develop this disorder. Many patients do not recall their stay in~     ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions,~     which may be very frightening for the patient to recall at a later stage. As yet, no~     interventional studies have had an impact on the development of PTSD in this population of~     patients. However, a recent observational multi-centre study suggested that those patients~     receiving a diary of their time in ICU had lower levels of symptoms of PTSD than those who~     did not. These results need to be verified in the form of a randomized study.~   "
202442|NCT00912600|"~     Percentage of patients over 80 admitted in ICU varies greatly from one center to another. ICU~     admission criteria of older patients are scarcely described and benefit of ICU admission for~     those patients is uncertain. In this study, we prospectively studied old patients arriving to~     the emergency department of 15 French hospitals with conditions that potentially warrant ICU~     admission.The working hypothesis was that ICU admission was associated with a 20% decrease in~     six-month mortality.~   "
202443|NCT00912587|"~     Ghrelin is a newly discovered peptide that is secreted by the stomach. Its main role is to~     stimulate food intake but recent studies indicate that it also acts on the cardiovascular~     system to confer beneficial effects. The mechanism of action is unclear but experimental~     studies suggest that ghrelin decreases the sympathetic nervous system. Beside there is new~     evidence in animal models that ghrelin may also be involved in stress reaction as ghrelin~     injection seems to protect against symptoms of stress. Given that circulating levels of~     ghrelin are reduced in obesity, this suggests that the effect of ghrelin may differ between~     lean and obese subjects. Ghrelin could represent an attractive therapeutic strategy for the~     treatment of cardiovascular diseases. The aim of the study if to gain more knowledge of the~     effect of ghrelin on the sympathetic nervous system and stress reactivity in both lean and~     obese subjects.~   "
202444|NCT00912574|"~     Goal: To characterize the cellular events that occur in vivo after vaccination with an~     emulsion of GMCSF-in-adjuvant.~      Design: Open-label, single dose study in two stages.~   "
202445|NCT00912561|"~     The purpose of this trial is to study the improvement of cerebral hemodynamics in high risk~     stroke patients with impaired Cerebrovascular Reserve (CVR) due to high grade stenosis of the~     internal carotid (ICA) or middle cerebral artery (MCA) by Intense Aerobic Exercise (IAEx).~   "
202446|NCT00912548|"~     The purpose of this study is to compare 5-year disease free survival rate (DFS rate) between~     the hormone receptor positive breast cancer patients who were added Goserelin to Tamoxifen~     for ovarian function suppression after neo-/adjuvant cytotoxic chemotherapy and the hormone~     receptor positive breast cancer patients who were treated with Tamoxifen.~   "
202447|NCT00912535|"~     The objectives of this study are to evaluate the efficacy and safety of quetiapine extended~     release tablet versus placebo as adjunct to selective serotonin reuptake~     inhibitors/serotonin/norepinephrine reuptake inhibitors (SSRI/SNRI) in the augmentation~     treatment of patient with primary anxiety disorders or mood disorders with co-morbid anxiety~     symptoms.~   "
202448|NCT00912522|"~     The investigators intend to study the role of the cortex in high- level cognition processes~     and sensory adaptation, by the use of non-invasive Transcranial Magnetic stimulation and~     various cognitive tests.~   "
202449|NCT00912509|"~     This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal~     cross linking system to treat corneal infections.~   "
202450|NCT00912496|"~     This research will study safety and the body's immune (defense system) responses, including~     anti-H5 flu antibodies (the body's protective proteins found in the blood), to an inactivated~     influenza H5 bird flu, virus vaccine. Participants will be assigned by chance to receive~     the vaccine injections with and without an adjuvant, (substance that can improve vaccine~     effectiveness so less vaccine may be used) MF59, or placebo (inactive substance). Five~     different vaccine dose strengths will be evaluated. About 735 healthy participants, ages~     18-49 will be asked to take part in this study. Study procedures include physical exam, blood~     sampling, and use of a memory aid. Volunteers will participate for up to 13 months.~   "
202481|NCT00912093|"~     This study is being conducted to evaluate the efficacy and safety of icatibant compared to~     placebo in patients experiencing acute attacks of hereditary angioedema (HAE).~   "
202451|NCT00912483|"~     The Venous thromboembolism (VTE) disease is very frequent, mainly as complications of medical~     diseases and surgical procedures. It has high prevalence and can lead to severe complications~     such as pulmonary embolism and postthrombotic syndrome. Although its incidence has been~     decreasing in recent years, the EP and DVT is still a major public health problem, especially~     in advanced age.~      The tracking of this disease through imaging tests in asymptomatic patients does not seem to~     be a cost-effective, further treatment of complications is expensive and subject to no~     satisfactory answers are not completely effective in regard to late complications. Therefore,~     according CAIAFA & BASTOS (2002), effective prophylaxis is the best strategy.~      The type of prevention to be used should be based on the risk of developing VTE, ie low,~     medium or high. Framework for a category of risk for the indication of prophylaxis, each~     patient should be evaluated individually and carefully to the risk of developing VTE. Maffei~     et al. (2005) describe the Standards for Clinical Guideline for the prevention, diagnosis~     and treatment of deep vein thrombosis. According to the guide, the concentration of heparin~     in 5.000UI is indicated for cases of moderate-risk surgeries. Are classified as moderate~     risk to more surgery (general, gynecological and urological) in patients 40 to 60 years~     without additional risk factors, and the magnitude of any surgery in patients under 40 years~     of age who use estrogen ( Annex 01). The dosing schedule chosen in this study also follows~     the recommendation of the guide and is universally used .~      According to Maffei et al. (2005), the diagnosis of VTE must be initiated by the history and~     physical examination, and then must be performed ultrasound Doppler of lower limbs. Thus, the~     ultra-sonography/doppler examination will be done at the beginning and end of treatment and~     physical examination will be done periodically throughout the period of monitoring.~      Following the guidelines proposed by the literature consulted, was established to test this~     methodology, which aims to demonstrate the non inferiority clinical heparin sodium 5.000UI /~     0.25 mL sodium heparin on 5.000UI / 1.0 mL, both produced by Blausiegel Industry and Trade~     Ltda. in reducing the incidence of VTE. The two formulations are produced from the same~     material, but have different drug concentrations. Thus, there is a need to scientifically~     prove that the therapeutic activity and safety of the product test is non-inferior to the~     comparator drug (APP heparina - 5.000 USP/mL), allowing the sponsoring company to obtain the~     registration of the product in the concentration of 5000UI /0.25 mL in ANVISA at the proposed~     therapeutic indication in the study.~   "
202452|NCT00912470|"~     The purpose of this study is to assess the correlation of vascular parameters, including~     genetic factors as well as ocular blood flow parameters against the progression rate of~     glaucomatous damage in patients with progressive OAG.~   "
202453|NCT00912457|"~     The purpose of this study is to determine the effects of the anticholinesterase drug~     donepezil on sleep apnea patients. Sleep structure and respiratory parameters will be~     analyzed by polysomnography.~   "
202454|NCT00912444|"~     The purpose of this study is to compare the pathological complete response (pCR) rate in~     triple-negative or Her2 positive breast cancer patients treated with neoadjuvant docetaxel,~     anthracycline and cyclophosphamide (TAC) or docetaxel and cyclophosphamide (TC) regimen.~   "
202455|NCT00912431|"~     The objectives of this study are to determine the cerebrospinal fluid (CSF) levels of ABT-126~     and to examine the effects of ABT-126 on exploratory biomarkers after administration of a~     single does of ABT-126 in healthy volunteers.~   "
202456|NCT00912418|"~     This study is an open-label, pilot study of an autologous tumor cell vaccine.~   "
202457|NCT00912405|"~     This study allows continued access to the Sinexus Intranasal Splint while a marketing~     application is being prepared. This study will generate additional performance, reimbursement~     and safety data for the steroid-eluting Sinexus Intranasal Splint when used following~     Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).~   "
202458|NCT00912392|"~     Background:~      The effect of existing treatment modalities of extensive disease small-cell lung cancer~     (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is~     wanted. Endostar® (Rh-endostatin Injection) may have anti-tumor activity by against vascular~     endothelial growth factor for initial treatment. This study was designed to evaluate the~     safety and efficacy of Endostar® combined with etoposide-carboplatin (EC) chemotherapy in~     patients with ED-SCLC seeking for more effective treatment.~   "
202459|NCT00912379|"~     The purpose of this study is to compare the hemoglobin results obtained with the Masimo SpHb™~     device and the Clinical Laboratory.~   "
202460|NCT00912366|"~     Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.~   "
202461|NCT00912353|"~     This is a Phase I, single center, randomized, double-blind, placebo-controlled single~     ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268~     in healthy Japanese subjects.~   "
202462|NCT00912340|"~     This phase II trial studies how well everolimus with or without trastuzumab works in treating~     patients with breast cancer that has not responded to hormone therapy and has spread from~     where it started to other places in the body. Everolimus may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving~     everolimus and adding trastuzumab at the time of disease progression may be an effective~     treatment for breast cancer.~   "
202463|NCT00912327|"~     Study BT-CL-PGG-CRC0821 is a Phase 2, open-label, multicenter, efficacy and safety study. It~     will be conducted using a two-stage design with the intention of determining the initial~     efficacy of Imprime PGG in combination with a monoclonal antibody (MAb; cetuximab) in the~     treatment of KRAS-mutant colorectal cancer (CRC). Both stages will be conducted in subjects~     with Stage IV CRC demonstrating the KRAS gene mutation. Subjects will dose until progression~     of disease or discontinuation from the study for other reasons; e.g., safety, non-compliance.~     Approximately 56 subjects will be enrolled at three participating centers (17 into Stage 1~     and 39 into Stage 2).~   "
202464|NCT00912314|"~     This study has 2 parts. Part 1 is a 12-week observational study of weekly Posterior Tibial~     Nerve Stimulation (PTNS) treatment for women with overactive bladder. Part 2 is a randomized,~     controlled trial of monthly maintenance PTNS therapy versus no therapy in subjects who were~     successfully treated by PTNS in Part 1.~      Part 1: 12-week observational study of weekly PTNS treatment.~      The primary aim of Part 1 is to determine the efficacy of a 12-week course of PTNS in the~     treatment of overactive bladder. Secondary aims are to determine the changes in voiding~     frequency and quality-of-life measures after the 12-week treatment.~      Part 2: Randomized, controlled study of monthly PTNS compared to no PTNS after 12-week~     treatment~      The primary aim is to determine time-to-failure after 12 weeks of PTNS in subjects who~     receive maintenance therapy compared to those who do not, in order to ascertain if there is a~     need for maintenance therapy after 12 weeks of PTNS. The investigators' secondary aims are to~     compare the long-term efficacy and quality of life impact in patient receiving maintenance~     PTNS compared to those that do not and to determine the efficacy of rescue maintenance PTNS~     in subjects who have symptom recurrence in the no maintenance therapy arm.~      Hypothesis: There will be no difference in time to failure between women randomized to~     monthly maintenance PTNS compared to no maintenance PTNS.~   "
202467|NCT00912275|"~     Phase I part: to determine the recommended dose, and observe the preliminary response and~     safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2~     positive metastatic breast cancer.~      Phase II part: to determine the progression free survival, response rate, and to evaluate the~     safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2~     positive metastatic breast cancer.~      Phase I part has been completed. Phase II part is underway.~   "
202468|NCT00912262|"~     The purpose of this single-blinded study in healthy volunteers is to select a~     Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the~     further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). The goal is to~     identify a low concentration formulation that will not reduce ENFD in healthy normal~     volunteers when compared to NGX-1998 (10% w/w) but would still produce some local~     capsaicin-related application site responses (e.g. erythema, heat sensation or pain) when~     applied.~   "
202469|NCT00912249|"~     Horticultural Therapy (HT) uses plants, gardening, and the close relationship between~     well-beings and plants. It integrates effort, hope, expectation, harvest and the enjoyment of~     whole process to help people with disabilities. During the process, patient can learn more~     about themselves and experience the nature.~      It can be traced to 1798, Dr. B. Rush found farm work helped people with mental illness.~     Today, horticulture therapy is well applied in disabilities, elderly and children. It needs~     detailed evaluation for the condition of illness to achieve optimal efficacy. It contains two~     parts- to sense and to operate! Patients can relax themselves and learn to work with others,~     realize the responsibility of caring another life, understand their relationship with~     environment. Patient can tolerate frustration better via acceptance the withered plants. In~     cultivation, it trains patient the occupational technique ( to operate instrument),~     communication, social skill, independence, stable mood.~      Based on studies, 0ne third patients with mental illness stabilized after treatment. However,~     aggressive rehabilitation is necessary to maintain their function. In our study, it plans to~     incorporate horticulture therapy into psychiatric clinical practice in our hospital. We plan~     to recruit horticulture therapist, visiting staffs, residents, occupational therapists and~     nurses to participate the design and operation in class.~      This program will recruit patients with schizophrenia, bipolar disorder, organic brain~     syndrome and other mental illness in our daycare. We will help patients with personal~     treatment record. We will use case study to report some typical cases. All the cases will be~     investigated qualitatively with intensive interview to explore the subjective experience on~     this therapy. We will also use simple questionnaire to found quantitative study in the~     further.~      To sum up, this program helps the connection for horticulture therapy and psychiatric~     rehabilitation. It promotes  patient-centered support and offers physical, mental , social,~     spiritual services. It not only produces academic performance but fulfills the ideal of~     holistic health care!~   "
202470|NCT00912236|"~     Obesity is associated with an impaired functioning HDL (good cholesterol) resulting in an~     acceleration in the development of atherosclerosis. This study will evaluate HDL~     functionality in patients with BMI (Body Mass Index) 20 - 25 and BMI >30~   "
202471|NCT00912223|"~     Blood stem cell transplants are one treatment option for people with lymphoma or other types~     of blood cancers. For this type of treatment, family members or unrelated donors with a~     similar tissue type usually donate their blood stem cells to the transplant patients. This~     study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower~     doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).~   "
202472|NCT00912210|"~     The broad aim is to determine efficacy of a weight loss diet higher in protein and lower in~     carbohydrate combined with low intensity exercise to favorably impact body composition, bone~     health, physical function, metabolic disease and quality of life compared to a conventional~     higher carbohydrate diet in overweight women over age 60.~   "
202473|NCT00912197|"~     This study seeks to look into the effects of oligofructose supplementation on appetite,~     energy intake, and body weight and body composition in overweight subjects. Compared to a~     placebo product (cellulose) oligofructose is hypothesised to suppress hunger and thereby~     reduce food intake moderately leading to a decrease in body weight.~   "
202474|NCT00912184|"~     This trial aims to study the effect of combining continuous and a new polyamide membrane with~     larger pores in the treatment of critically ill patients with acute renal failure and low~     blood pressure (shock) requiring noradrenaline. The investigators wish to compare the~     clinical effect of this new therapy to that of haemofiltration with a standard membrane.~   "
202475|NCT00912171|"~     The aim of the project is to evaluate whether therapy with leukotriene may be a valid~     therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate~     obstructive sleep apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally~     or more efficient than nasal steroid.~   "
202476|NCT00912158|"~     Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation~     (NIV) in addition to conventional medical treatment might be beneficial for patients with~     CPE.~   "
202477|NCT00912145|"~     To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg.~   "
202478|NCT00912132|"~     Normal fetal growth is a critical component of a healthy pregnancy and the long-term health~     of the offspring. Pivotal to understanding the dynamics of human fetal growth and to defining~     normal and abnormal fetal growth is the development of standards for fetal growth. The~     study's purpose was to establish standards for normal fetal growth and size for gestational~     age for 4 racial/ethnic groups of pregnant women with the eventual creation of individualized~     standards for fetal growth and improvements in fetal weight estimation. These data for a~     contemporary cohort of pregnant women should provide data for clinical management.~   "
202479|NCT00912119|"~     Craniofacial reconstruction surgery involves a surgical approach to the craniofacial region~     to repair cranial vault and facial deformities. The surgery is extensive, often requiring~     wide scalp dissections and multiple osteotomies and has been associated with significant~     morbidity. Some of the most severe and commonly seen problems are associated with the rate~     and extent of blood loss.~      Efforts to minimize surgical bleeding may translate to reduced transfusion requirements and a~     lessening of associated risks Epsilon-aminocaproic acid (EACA), an inhibitor of fibrinolysis,~     reduces transfusion requirements in children undergoing procedures on cardiopulmonary bypass~     (CPB), as well as in older children undergoing spinal surgery for scoliosis (1-6).~      Before controlled studies to assess efficacy of EACA in a craniofacial surgical population~     can be done, appropriate pharmacokinetic (PK) data are needed to determine the optimal dosing~     strategy. PK data exist for EACA in children undergoing operations on CPB and hypothermia.~      The aim of this study is to determine the pharmacokinetics of EACA in infants and children~     undergoing craniofacial reconstruction procedures.~   "
202480|NCT00912106|"~     To analyze the relationship between composition of synovial fluid and its lubrication~     properties~   "
202482|NCT00912080|"~     Method: This multicentric prospective cohort is composed of patients with no metastatic~     breast cancer selected by tumor's genomic analysis and treated by chemotherapy with~     Anthracycline without Taxanes (6 cycles of FEC 100).~      The patient can be included before or after the surgery and a written consent must be signed~     for the proteomic and genomic analysis of the tumor.~      Patients who have a good signature for the genomic analysis will receive the standard~     chemotherapy.~      Primary objective:~        -  To compare metastasis free survival at 5 years in a cohort of patients with no~          metastatic breast cancer, who are selected by their genomic profile of the tumor and~          received a standard chemotherapy containing Anthracycline, with result of retrospectives~          studies.~      Secondary Objectives:~        -  Overall survival.~        -  Creation of a circuit (transport-extraction-genomic analysis-result) which allows the~          beginning of the chemotherapy within 6 weeks following the primary surgery.~        -  Histological and seric proteomic exploratory studies.~   "
202483|NCT00912067|"~     The purpose of this study is to evaluate the presence and manifestations of ocular graft~     versus host disease in adults that had hematopoietic stem cell transplantation in the past 3~     years at the sheba medical center, Israel. As well as correlate the degree of the~     presentation to the therapeutic protocol (chemotherapy and irradiation).~   "
202484|NCT00912054|"~     To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health in patients~     with open angle glaucoma or ocular hypertension.~   "
202485|NCT00912041|"~     The purpose of this study is to obtain preliminary device safety information and demonstrate~     proof of principle (feasibility of efficacy) of the ability of people with tetraplegia to~     control a computer cursor and other assistive devices with their thoughts.~   "
202486|NCT00912028|"~     The purpose of the study is to evaluate the possible benefits of second generation silicone~     hydrogel contact lenses.~   "
202487|NCT00912015|"~     The purpose of this study is to evaluate the long-term safety (up to one year) of Tramadol~     Once-A-Day (OAD) tablets at the highest doses: 200-400 mg~   "
202488|NCT00912002|"~     A single dose, open label study to characterize the routes of elimination and determine the~     mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male~     participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples~     will be collected to determine relative quantities of 14C-labeled MK-0941.~   "
202489|NCT00911989|"~     The main objective of this trial is to evaluate endoscopic visualization during a~     laparoscopic sleeve gastrectomy (LSG) procedure using an endoscope inserted transvaginally~     through a new device called a Steerable Flex Trocar (SFT).~   "
202490|NCT00911976|"~     The specific aim of the SOS-Xience V study is to examine the 12-month incidence of binary~     angiographic in-stent restenosis after implantation of the Xience V stent in aortocoronary~     saphenous vein bypass graft lesions.~   "
202491|NCT00911963|"~     The purpose of this study is to assess antiviral activity when administered alone for 3 days~     or in combination with peginterferon and ribavirin for 12 weeks. This study will also~     evaluate the safety and tolerability of treatment with VCH-222 when given alone or in~     combination with peginterferon and ribavirin.~      The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.~   "
202492|NCT00911937|"~     This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on~     micturition related nocturnal urgency episodes.~   "
202493|NCT00911924|"~     Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle~     glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication~     added at 6 months, as required.~   "
202494|NCT00911911|"~     The scope of the trial is to identify proteomic signatures correlated with tumor response to~     neo-adjuvant chemotherapy.~   "
202495|NCT00911898|"~     This study is an open-label Phase 1 trial of MM-111.~   "
202496|NCT00911885|"~     Identifying a simple dietary recommendation for weight loss and metabolic health may~     demonstrate potential for a simple public health message to impact coronary heart disease~     (CHD) prevention and metabolic syndrome. In a randomized clinical trial, the investigators~     propose to compare the efficacy of two intervention approaches to dietary change for CHD~     prevention among persons with metabolic syndrome. The two approaches are 1) the AHA Dietary~     Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. The~     investigators hypothesize that a message promoting high fiber intake may be the simple~     message that has potential to produce broad impact.~   "
202497|NCT00911872|"~     The purpose of this study is to gather information about the immediate effects and recovery~     time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it~     takes for patients to feel comfortable with the results, and return to their normal daily~     routine is also of important interest~   "
202498|NCT00911859|"~     The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab)~     when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with~     VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and~     bone marrow).~   "
202499|NCT00911846|"~     Main intention of this study is to find out whether there is a difference between the~     attitudes towards opioid- substitution of opioid dependent patients under substitution with~     methadone, buprenorphine or without substitution and their therapists~   "
202509|NCT00911716|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) together with bevacizumab may kill more tumor cells.~      PURPOSE: This clinical trial is studying the side effects of giving bevacizumab together with~     docetaxel and cyclophosphamide and to see how well it works in treating patients with~     early-stage high-risk breast cancer.~      This is a single arm, non randomised pilot study investigating the safety of the combination~     of Docetaxel + Cyclophosphamide+ Bevacizumab in the adjuvant treatment of patients with early~     stage, HER 2 negative, high risk breast cancer.~   "
202581|NCT00910767|"~     The main objective of this study is to evaluate the feasibility of closed loop insulin pump~     therapy to improve overnight glucose control in adults with type 1 diabetes.~   "
202500|NCT00911833|"~     Background:~        -  Genetic research has implications for drug development and marketing. Race-based~          medicine may be able to provide specific treatment for populations with increased~          disease-specific morbidity and mortality. However, contemporary genetic research refutes~          the idea that races are genetically distinct populations, even as drugs designed for use~          in specific races are being promoted.~        -  Studies have shown high levels of public suspicion for race-based and personalized~          genetic medicine. Concerns related to not only the potential performance of race-based~          drugs, but also the motives of those offering these drugs. Many participants have~          suggested conspiracy theories in which race-based medicine was disguising an attempt to~          provide inferior medications or deliberately harm certain populations. Concerns about~          personalized medicine often have to do with privacy and other personal concerns.~        -  Public suspicions of race-based medicine, and to a lesser extent, personalized genetic~          medicine, make it important to examine and understand the theoretical and empirical~          literature on trust and health care.~      Objective:~      - To describe the perspective of participants evaluating the medicine offer.~      Eligibility:~        -  Males and females ages 18 and older who are visiting the John Hopkins clinics (primarily~          the adult care clinics).~        -  Participants must be able to take a literacy screen and respond to a short survey.~      Design:~        -  Participants will be asked to take a researcher-administrated literacy screen, read one~          of three randomly assigned vignettes, and fill out a survey. The first page of the~          survey will provide information about the study.~        -  Participants will respond to initial questions about demographics, experiences with~          discrimination, and trust in the medical profession and institutions.~        -  Each participant will receive a random vignette in which he/she will imagine him/herself~          being diagnosed with a common, chronic condition and offered a conventional drug, a~          race-based drug, or a genetically personalized drug.~        -  After being presented with the vignette, participants will be asked to respond to a~          survey that asks about their levels of trust in the vignette doctor, perceived respect~          given to the patient by the vignette physician, emotional response to the vignette,~          their belief in the effectiveness and safety of the drug prescribed in the vignette,~          information sufficiency, and their hypothetical behavioral intention to take the drug.~        -  Participants will be debriefed after completing the survey, and will be offered a small~          amount of compensation for participating.~   "
202501|NCT00911820|"~     There is no clear standard of care for metastatic stomach or esophageal cancer in the United~     States. The purpose of this research study is to determine the differences between two~     regimens of chemotherapy; Arm A: PCA (Cisplatin, Irinotecan and Bevacizumab) and Arm B: TPCA~     (Docetaxel, Cisplatin, Irinotecan and Bevacizumab). Docetaxel, Cisplatin, and Irinotecan are~     traditional chemotherapy drugs. Bevacizumab is an antibody (a protein that attacks a foreign~     substance in the body). Bevacizumab is believed to stop the formation of new blood vessels~     that carry nutrients to tumors. Both of the chemotherapy regimens (PCA and TPCA) have been~     studied in patients with esophageal and gastric cancer, and we are trying to determine if one~     regimen will keep your cancer from growing and improve how long you can live.~   "
202502|NCT00911807|"~     The study was performed to compare the safety and efficacy of Cerebrolysin (10 mililiters~     [ml]), Aricept (10 miligrams [mg]), and a combination of both treatments on cognitive~     performance and global function in patients with probable Alzheimer's Disease (AD). It should~     also be assessed if the treatments have a positive effect on activities of daily living and~     neuropsychiatric symptoms.~      Oral treatment with Aricept or Placebo was given once daily throughout the study. Intravenous~     treatment with Cerebrolysin or Placebo was given once daily for 5 days per week during week 1~     to 4 and during week 13 to 16 of the study. During the study patients had six visits at the~     hospital for evaluation.~   "
202503|NCT00911794|"~     The purpose of this study is to determine whether Written Disclosure Therapy (WDT) is of any~     benefit to patients with chronic lung diseases who are participating in pulmonary~     rehabilitation.~   "
202504|NCT00911781|"~     One of the most important and unique characteristics of infantile hemangiomas is their~     dramatic growth during early infancy. Most hemangiomas are either absent at birth or barely~     evident as a small scratch or bruise-like area. A recent study emphasized how early~     hemangioma growth occurs. In this study by 3 months of age, hemangiomas had reached 80% of~     their final size, and by 5 months of age, 80% had already stopped growing. Unfortunately the~     average age when most infants are seen by specialists is often at 5 months of age or later, a~     time when most growth is already completed.~      Researchers at the University of California, San Francisco, the Medical College of Wisconsin,~     and at the Mayo Clinic are interested in studying hemangioma growth at even earlier ages,~     before 3 months of age, which is before most patients are ever seen by dermatologists or~     other specialists. For this study are requesting that parents of children older than 3 months~     of age with hemangiomas send us a series of photographs of their child which demonstrates~     this early growth. Ideally the photographs would show your child (including the area of the~     hemangioma of course) at weekly or every other week intervals up until age least 3 to 6~     months of age. This will probably not be difficult if the hemangioma is on the face but we~     would be interested in other body locations as well, if available.~      We are using these photographs to analyze early hemangioma growth patterns, to see if there~     is a period of especially rapid growth, and to help determine if there is a specific time~     before which specialty referral should occur. We are interested in all sizes of hemangiomas,~     from small to large. Of greatest importance is that the photos be at frequent intervals~     (every 1 to 2 weeks is ideal) and of sufficient quality to be able to evaluate the appearance~     of the hemangioma.~   "
202505|NCT00911768|"~     The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth~     (Xerostomia).~   "
202506|NCT00911755|"~     Endotracheal Intubation (ETI) is done to place a plastic tube in a patient's trachea~     (windpipe) to assist with breathing. Patients admitted to the intensive care unit (ICU) are~     the sickest of patients and the majority of them require this life saving procedure. A~     critical illness can be sudden and ETI required urgently. The doctors performing ETI in these~     situations may not be experts at ETI. Studies have shown that if it takes more than one~     attempt to get the tube in the right position patients can have severe complications such as:~     decrease level of oxygen in the body, decrease blood pressure, and cardiac arrest. These~     complications can be life threatening and increase the length of time spent in an ICU.~      To perform ETI the doctor uses a metal tool called a laryngoscope that is placed through the~     patient's mouth to open the throat and then pass the tube into the trachea. The type of~     procedure that has been used for many years is called Direct Laryngoscopy (DL) which means~     that the doctor looks through the mouth directly into the throat. Newer technology is~     available and can be used at VGH called Video Laryngoscopy (VL). With VL there is a camera on~     the end of the laryngoscope and a video image is displayed on a monitor making it easier to~     see the entrance to the trachea. VL is not available for all cases at VGH and is unavailable~     in many other hospitals.~      In this study we will compare DL to VL. Patients will be randomly placed in one of two~     groups: first attempt at ETI done with DL or first attempt of ETI done with DL. Patients will~     only be considered eligible for this study if the doctor feels that either DL or VL would be~     appropriate for the patient. In this pilot study we hope show that conducting a larger study~     would be feasible. If a larger study were to show that VL decreases complications and~     shortens length of ICU stay we would be able to recommend this procedure for all ETI at VGH~     as well as other hospitals where it currently may not be available.~   "
202507|NCT00911742|"~     The main purpose of this study is to compare the pharmacokinetic profile to establish the~     better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg,~     Labopharm) and its bioavailability in relation with the commercialised reference (Zytram®~     tablets of 200 mg, Zambon), single dose administered.~   "
202508|NCT00911729|"~     The purpose of this qualitative study is to evaluate the clarity and comprehensiveness of two~     disease-specific questionnaires, and to evaluate how effective these questionnaires are at~     assessing the quality of life and symptoms of patients with pheochromocytoma or~     paraganglioma.~   "
202510|NCT00911703|"~     The purpose of this study is to determine if certain findings (blood tests, symptom~     improvement, etc.) after acute heart failure treatment can identify a group of patients who~     are safe for early hospital discharge.~   "
202601|NCT00910507|"~     The purpose of this randomized clinical trial is to investigate the impact of physical~     therapist-directed exercise counseling combined with fitness center-based exercise training~     on stage of exercise behavior in people with type 2 diabetes.~   "
202511|NCT00911690|"~     This study is collecting tissue specimens (blood, urine and saliva) from up to 1000 patients,~     with and without cognitive disorders, to store in the Bio Bank for future research. The~     specimens could be used in future research projects that could help improve the accuracy of~     diagnosis of a disease, predict who might develop a disease, help monitor the disease, or~     improve the understanding of the disease. Patients are only being recruited from Beaumont~     Hospitals Geriatric Clinic.~   "
202512|NCT00911677|"~     Patients with the APOE-ε4 genotype are at increased risk of both vascular dementia and~     peripheral vascular disease. Patients undergoing major vascular surgery are at particularly~     high risk of delirium and other, more subtle, changes in cognitive function following~     surgery. The hypothesis of this trial is that the APOE-ε4 genotype is associated with both~     delirium and postoperative cognitive dysfunction (POCD).~   "
202513|NCT00911664|"~     To find out if vitamin D supplementing can lead to an improvement in immunological status in~     HIV-infected children as part of routine clinical care~   "
202514|NCT00911651|"~     The objectives of this study are to assess the effect of salbutamol in comparison with~     ipratropium bromide on the geometry of central and peripheral airways and to correlate~     spirometric indices with the Computational Fluid Dynamics (CFD) based calculated airway~     volumes and resistances for both compounds.~   "
202515|NCT00911638|"~     Ministries of Health consider wait lists for total joint replacement a top priority. Research~     priorities to manage wait lists indicate the need to establish benchmarks that consider~     patient preferences. However, patients' preferences for hip or knee replacements are strongly~     associated with their misperceptions of the indicators for, and the risks and benefits of,~     these procedures. These misperceptions can be corrected with the use of patient decision~     aids. When decision aids are used in combination with assessing surgical eligibility, there~     may be a reduction in unnecessary referrals for surgery either because the patient is~     ineligible or because the eligible candidates make informed decisions to forgo this option.~     The primary study objective is to evaluate the effect of patient decision aids (PtDAs) on~     total wait times (wait times for surgical consultation, plus wait times for surgery) when~     used in combination with a general practitioner run clinic to screen patients with hip or~     knee osteoarthritis for surgical eligibility. Major secondary objectives include determining~     (a) the effect of PtDAs on surgery rates within two years, (b) the effect of PtDAs on~     decision quality, and (c) cost-effectiveness of PtDAs for total joint arthroplasty.~   "
202516|NCT00911625|"~     It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in~     renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily~     plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction~     algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR~     by MDRD as follows: < 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based~     calculation.~   "
202517|NCT00911612|"~     Our hypothesis is that the medication approved for treatment of high blood cholesterol~     levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients~     with diarrhea due to irritable bowel syndrome.~      This effect is thought to result from the effect of the medication on bile acids, which can~     cause diarrhea.~   "
202518|NCT00911599|"~     The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium)~     are lower at one year in patients who receive a metal on polyethylene total hip as compared~     to CONSERVE® A-Class Total Hip with BFH® technology. Secondary aims include the gathering of~     clinical data regarding survival and dislocation rates at two years post surgery, as well as~     the assessment of pain, physical function, radiographic and clinical outcome at the two year~     interval.~   "
202519|NCT00911586|"~     The purpose of the study is to confirm how long (i.e., how many days) it takes to reach~     steady-state when testosterone undecanoate is administered twice daily.~   "
202520|NCT00911573|"~     The main purpose of this study is to compare the safety and efficacy of tigecycline versus~     clindamycin (including subjects treated with vancomycin) in pediatric subjects (aged 8 to 17~     years) with complicated skin and skin structure infections (cSSSI), including those caused by~     methicillin-resistant staphylococcus aureus (MRSA).~   "
202521|NCT00911560|"~     The purpose of this study is to test the safety and what effects, good and/or bad, treatment~     with a vaccine against neuroblastoma has on the patient and the cancer. In the first part of~     this study we found the highest dose of the vaccine that did not have too many side effects.~     We are now trying to find out what effects the vaccine has when given at the same dose to all~     patients.~      The main treatment in this protocol is a vaccine. It is called a  bivalent vaccine which~     means it has 2 antigens. An antigen is a specific protein on the surface of a cell. The~     antigens are called GD2L and GD3L.~      We want the vaccine to cause the patient's immune system to make antibodies against the~     antigens. Antibodies are made by the body to attack cancer (and to fight infections). If the~     patient can make antibodies against the 2 antigens in the vaccine, those antibodies might~     also attach to neuroblastoma cells because a lot of each antigen is on neuroblastoma (and~     very little on other parts of the body). Then, the attached antibodies would attract the~     patient's white blood cells to kill the neuroblastoma. This protocol also uses β-glucan which~     is a kind of sugar from yeast. β-glucan is taken by mouth and can help white blood cells kill~     cancer. The best way to get the body to make antibodies against the 3 antigens is to link~     each antigen to a protein called KLH (which stands for: keyhole limpet hemocyanin) and to mix~     them with a substance called QS-21. But it is hard to get enough QS-21 so we are using an~     identical substance called OPT-821, which we can get easily in large amounts for use in~     patients.~   "
202522|NCT00911547|"~     This study will investigate the additive effect of montelukast (MK0476) taken along with~     inhaled beclomethasone versus inhaled beclomethasone alone.~   "
202523|NCT00911534|"~     The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole~     extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux~     disease (sGERD).~   "
202524|NCT00911521|"~     The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on~     the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus~     erythematous and compare the antibody response with an equal number of age-matched healthy~     women.~   "
202602|NCT00910494|"~     The investigators would like to test the safety and efficacy of intraoperative radiotherapy~     (IORT) in rectal cancer using the Photon Radiosurgery System (PRS).~   "
202525|NCT00911508|"~     The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial)~     CABANA Trial has the overall goal of establishing the appropriate roles for medical and~     ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the~     hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of~     eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy~     with either rate control or rhythm control drugs for decreasing the incidence of the~     composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest~     in patients with untreated or incompletely treated AF.~   "
202526|NCT00911495|"~     This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with~     stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular~     effects of intravenous GMI-1070 in the outpatient setting.~   "
202527|NCT00911482|"~     The overall hypothesis of these studies is that circulating triglycerides, coming primarily~     from fat in the diet, are an important source of free fatty acids. Free fatty acids are the~     major fat fuel in the body, and when they are elevated in the blood they are thought to raise~     the risk of cardiovascular disease by causing insulin resistance (in some cases leading to~     diabetes), raising blood pressure, and other effects. The investigator will use sophisticated~     methods for tracing triglycerides and free fatty acids in the blood. These methods involve~     the administration of low doses of radioactive and stable isotopes of naturally occurring~     fats. The studies will determine the contribution of triglycerides to free fatty acids in~     normal people and also in people with diabetes.~   "
202528|NCT00911469|"~     Osteoarthritis (OA) is one of the most common diseases affecting the joints, usually those~     that are weight bearing such as the knees. OA is considered to be a disease of the cartilage~     in the joints even though it involves the whole joint, including the bone and synovium (thin~     lining of the joints which produces synovial fluid). With time, more and more of the~     cartilage is destroyed by the disease with inflammation commonly occurring.~      AS902330 is expected to increase the production and development of specific bone cells:~     chondrocytes and osteoblasts (cells that produce and maintain bone and cartilage). This is~     expected to lead to repair and regeneration of the cartilage, and a narrowing of the space~     width between the knee joints in a selected region of the knee.The purpose of this study is~     to see how safe treatment with AS902330 is, and to evaluate its effect on the knee cartilage.~     In addition, the study will also measure the effects of AS902330 in the blood.~   "
202529|NCT00911456|"~     To determine if the Clarity 3DUS (3D Ultrasound) system can be used by multiple individuals~     to acquire 3DUS images and produce consistent TB (Tumor Bed) shifts for breast IGRT~     (Image-Guided Radiation Therapy).~   "
202530|NCT00911443|"~     The purpose of the study is to test safety and efficacy of different doses of thymosin alpha~     1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon~     alpha in treating patients affected by stage IV melanoma.~      Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In~     Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free~     Survival.~      Ninety-five patients are allocated to each arm to test the hypothesis that P0 <= 0.05 vs the~     alternative hypothesis that P1 >= 0.15 (alpha = 5%, within-group statistical analysis beta =~     95%).~   "
202531|NCT00911430|"~     The incidence of community-associated (CA) staphylococcal infections, especially those caused~     by methicillin-resistant Staphylococcus aureus (MRSA), has increased dramatically in recent~     years. Although the majority of these infections are limited to the skin and soft tissue and~     thus not life threatening, the number of invasive cases in otherwise healthy individuals is~     increasing and some are fatal. As a first step toward understanding pathogenesis, there has~     been significant focus on elucidating the key CA-MRSA virulence factors. The relative~     significance of these factors is still being delineated. By comparison, there has been little~     focus on host factors associated with these invasive infections. In this protocol, we will~     recruit 100 otherwise healthy subjects with invasive staphylococcal infection, 50 otherwise~     healthy subjects with recurrent staphylococcal infections, and obtain samples from 150~     unidentified healthy controls from the blood bank to investigate host immunologic factors~     predisposing people to staphylococcal infection. Subjects will receive standard of care~     treatment for acute or recurrent staphylococcal infections. The primary objective of this~     research is to identify host genetic factors that contribute to susceptibility or severity of~     community acquired staphylococcal diseases. We will use three experimental approaches to~     complete this objective: 1) expression microarray analyses of study population s (subjects~     and controls) white cells (neutrophils and peripheral blood mononuclear cells) at rest and~     stimulated with staphylococci, 2) evaluation of toll-like receptor (TLR) pathways in the~     study population s cells, and 3) evaluation of Th17 cells. The proposed research will address~     a key area of staphylococcal pathogenesis for which there is a striking lack of information.~     We fully anticipate that the research also will provide critical new information directly~     relevant to vaccine, diagnostics, and therapeutics development....~   "
202532|NCT00911417|"~     The Jetstream System is a commercially available rotating, aspirating, expandable catheter~     designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of~     this study is to use intravascular ultrasound (IVUS) during the interventional procedure to~     measure the amount of plaque and blood clots removed by the Jetstream System.~   "
202533|NCT00911404|"~     There is evidence that controlling total amount of carbohydrates is a strategy for~     controlling glucose levels in diabetes mellitus. There is not major evidence that any given~     macronutrient percentage may be recommended to treat a woman with Gestational Diabetes~     Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once~     medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy.~     Insulin treatment is more expensive and not as well accepted as MNT. The investigators have~     designed a randomized-controlled trial to assess whether a diet with 40% total calories from~     carbohydrates may reduce the need of insulin treatment in women with gestational diabetes,~     without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total~     calories from carbohydrates.~   "
202548|NCT00911209|"~     The focus of this study is to observe the impact of weight loss in overweight individuals who~     have pre-hypertension (have a blood pressure reading of 121-139/81-89 mm Hg). The specific~     focus is to observe the difference in diastolic dysfunction (heart function) in these~     individuals at the beginning of the study and then again after 24-28 weeks. Diastolic~     dysfunction in this population indicates an increased risk of heart failure in the future.~     The aim of this study is to prevent or reduce the risk of heart failure in overweight~     individuals with pre-hypertension.~   "
202582|NCT00910754|"~     The purpose of this study is to determine the effect of abiraterone acetate plus prednisone~     on the conduction of electric charges within the heart and to determine the blood levels of~     abiraterone acetate following administration in patients with metastatic castration-resistant~     prostate cancer.~   "
202534|NCT00911391|"~     Perioperative fluid management has been historically dictated by outdated, contradictory~     concepts. Excessive or inadequate fluid administration around surgery is deleterious and~     hence goal-directed fluid therapy using Oesophageal Doppler-derived cardiac indices is~     preferable to optimize tissue perfusion. Previous studies in this area have been hampered by~     lack of standardization in other aspects of perioperative care and none have explored the~     impact of individualized fluid therapy on post-operative fatigue.The investigators proposed a~     study involving 80 patients having open/ laparoscopic colonic surgery to investigate the~     effect of Oesophageal Doppler guided fluid administration intraoperatively compared to~     current best practice of fluid restriction. The investigators have an optimized~     peri-operative care pathway established at the Manukau Surgical Centre (MSC), Middlemore~     Hospital. All patients will be cared for under the Enhanced Recovery After Surgery (ERAS)~     multimodal care plan therefore ensuring that all other aspects of care besides intraoperative~     fluid administration remain homogenous. Outcomes will include post-operative recovery,~     clinical outcomes as well as physiological data with follow-up to 30 days.~   "
202535|NCT00911378|"~     This study is a comparison of two most commonly used modes of weaning and the outcomes in the~     two groups.~   "
202536|NCT00911365|"~     This study is based on positive results in open label trial of mesenchymal stem cells therapy~     in patients with Multiple System Atrophy (MSA).~   "
202537|NCT00911352|"~     Between 30% and 88% of chemotherapy patients receiving docetaxel experience side effects of~     the hand ranging from skin and nail disfigurement, blistering, desquamation, pain, infection,~     and impaired treatment-related quality of life and function. Preliminary data indicate that~     nurse-initiated cryotherapy during treatment may lower the incidence and severity of these~     side effects, but several issues should be addressed before this intervention is implemented~     in hospital settings. These include more rigorous study design, larger sampling frames, and~     consideration of infection control concerns. This study will address these issues, thereby~     rigorously evaluating the safety and efficacy of nurse-initiated cryotherapy at Princess~     Alexandra Hospital.~   "
202538|NCT00911339|"~     The purpose of this study is to evaluate the extent of the mobilization of endothelial~     progenitor cells induced by low versus high dose atorvastatin after 4 weeks of treatment, in~     patients treated with anti-CD 34 antibodies coated stent.~   "
202539|NCT00911326|"~     The purpose of this study is to determine the false negative rate (FNR) associated with~     Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of~     non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell~     carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement~     NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or~     melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent~     to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic~     pathway draining the primary site of a tumor.~   "
202540|NCT00911313|"~     The purpose of this study is to compare and determine the efficacy of letrozole~     administration to that of combined metformin and Clomiphene in infertile women with~     polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.~   "
202541|NCT00911300|"~     The purpose of this study is to test whether Fondaparinux is effective and safe to prevent~     thromboembolic events (like for example strokes) and bleeding events in patients who undergo~     a normalisation of their heart rhythm disturbance. Fondaparinux will be compared with Heparin~     and tablets containing Vitamin-K-Antagonists (Phenprocoumon, Fluindione, or Warfarin).~   "
202542|NCT00911287|"~     The purpose of this study is to determine if oxymorphone ER is effective and safe in treating~     chronic pain in opioid-naive patients.~   "
202543|NCT00911274|"~     The objective of this study was to compare the oral bioavailability of an investigational~     formulation of mycophenolate mofetil (MMF) 250 mg capsules to an equivalent dose of the~     commercially available reference product, CellCept® (mycophenolate mofetil) 250 mg~     administered to healthy subjects following an overnight fast of at least 10 hours.~   "
202544|NCT00911261|"~     The purpose of this study is to determine if Oxymorphone Extended Release is effective and~     safe in treating chronic pain in patients with cancer or neuropathic pain.~   "
202545|NCT00911248|"~     Formation of new blood vessels (angiogenesis) is important for tumor growth in~     neurofibromatosis type 2 (NF2). It is known that tumors make a protein called vascular~     endothelial growth factor (VEGF) and there are higher levels of VEGF in the tumors and blood~     of many patients with NF2. VEGF stimulates the formation of blood vessels that supply the~     tumor with nutrients and oxygen. PTC299 is an oral drug that has been shown to decrease~     production of VEGF in animal models of human cancer. In these animal models, oral PTC299~     administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood~     vessel numbers in the tumor, and significantly slows or halts tumor growth. Safety studies in~     research animals indicate good tolerability at doses and drug levels that are higher than~     those planned for the clinical studies. Results from Phase 1a studies in healthy volunteers~     indicate that PTC299 achieves levels of PTC299 in the bloodstream that are known to be active~     in animal models of human tumor. This Phase 2 study is designed to test the hypothesis that~     PTC299 will be tolerable and will show evidence of VEGF reduction, antitumor activity, and~     hearing improvement when administered orally to patients with NF2.~   "
202546|NCT00911235|"~     This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a~     moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine~     in healthy adult subjects.~   "
202547|NCT00911222|"~     The purpose of this registry is to record information on reality of anti-emetic therapies of~     cancer-patients in Germany. The outcome of this study is the efficacy of anti-emetic~     therapies dependent on the rate complete and major control of nausea and emesis in~     moderately and highly emetogenic chemotherapies, consisting of platin-derivates (cisplatin,~     carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.~   "
202549|NCT00911196|"~     Hepatocellular carcinoma is an aggressive disease with limited therapeutic options.~     Therefore, new approaches to treat this type of cancer are needed with immunotherapy~     potentially being one of these. As a first step in the development of novel therapies,~     expression analysis of specific markers, including tumor antigens will be carried out, and~     the correlation of expression with disease variables and clinical outcome will be assessed.~     This will be done retrospectively using archived hepatocellular carcinoma tissue samples.~   "
202550|NCT00911183|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as cyclophosphamide, vincristine sulfate, prednisone, and liposome-encapsulated doxorubicin~     citrate, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. It is not yet known whether rituximab and~     combination chemotherapy are more effective when given together with or without~     liposome-encapsulated doxorubicin citrate in treating older patients with diffuse large~     B-cell non-Hodgkin lymphoma.~      PURPOSE: This randomized phase II trial is studying the side effects of giving rituximab~     together with cyclophosphamide, vincristine sulfate, and prednisone with or without~     liposome-encapsulated doxorubicin citrate and to see how well it works in treating older~     patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin lymphoma.~   "
202551|NCT00911170|"~     This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating~     the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients~     with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line~     treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or~     5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).~      This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either~     FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall~     response rate in each arm at regular intervals over a maximum of 60 months follow-up.~   "
202552|NCT00911157|"~     The primary objective of this study is to evaluate the efficacy (as measured by the rate of~     recurrent symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and~     Deep Vein Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects~     with acute symptomatic DVT in an open-label design.~   "
202553|NCT00911144|"~     The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a~     booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix~     at 12-18 months of age, in children primed with the same vaccines in primary study~     NCT00680914.~   "
202554|NCT00911131|"~     Increasing intra-abdominal pressure (IAP) with an abdominal binder will increase pressure~     within smaller esophageal varices which will therefore enhance the ability of capsule~     endoscopy to detect these varices better.~      Therefore, the aims of the investigators' study are as follows:~        1. To determine if using an abdominal binder to increase IAP can increase the detection~          rate of small esophageal varices when using capsule endoscopy.~        2. To determine if using an abdominal binder to increase IAP during capsule endoscopy has a~          comparable detection rate of small esophageal varices to conventional endoscopy.~   "
202555|NCT00911118|"~     The purpose of this study is to test the safety of a new type of IG-IMRT called~     ultra-hypofractionated IG-IMRT where a higher dose of radiation is given to the tumor~     during each treatment day. Since higher doses of radiation are used each day, the total~     number of treatment days needed to complete this type of radiation is only five instead of~     the 45-48 treatments currently used. Treatment takes place every other day and is complete~     after 2 weeks. If the patient decides to get this treatment, they will come in for 5~     treatments. This is different from the 48 treatments they would get normally.~   "
202556|NCT00911105|"~     Purpose of this non-interventional study is the documentation of efficacy and safety data of~     multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily~     routine practice.~   "
202557|NCT00911092|"~     The scope of the trial is to predict the early complete clinical response to exclusive~     concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per-~     therapeutic proteomic profile.~   "
202558|NCT00911079|"~     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above~     normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the~     tumor cells without affecting the surrounding tissue. Implant radiation therapy uses~     radioactive material placed directly into or near a tumor to kill tumor cells. Giving~     ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.~      PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it~     works after implant radiation therapy in treating patients with Stage III/IV cancer of the~     cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local~     therapy.~   "
202559|NCT00911066|"~     An open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients with~     acute myelogenous leukemia (AML), high-grade myelodysplastic syndrome (MDS). The patient~     population will consist of adults previously diagnosed with AML including high-grade MDS for~     which standard curative, life-prolonging treatment does not exist or is no longer effective.~   "
202560|NCT00911053|"~     This research project consists of a three part study with five embedded sub studies. The~     first study phase identifies body rhythms of sleepiness/wakefulness and of melatonin levels~     for each subject (including sub-study 1). The second study phase identifies the optimum dose~     and timing of melatonin for regulating each individual's 24-hour sleep/waking cycle~     (including sub-study 2). The third study phase introduces a new independent variable, light~     (including sub-studies 3 and 4). Sub-study 5 is an optional longitudinal study.~      Sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm.~     Sub-study 2 looks at how individuals metabolize melatonin. Sub-study 3 tests how individuals'~     endogenous melatonin production responds to bright outdoor light and Sub-study 4 tests a~     previous finding that artificial bright light exposed daily behind the knee can regulate the~     body clock. Sub-study 5 is an optional longitudinal study, an extension of the first study~     stage, for subjects whose rhythms are not clearly free-running.~   "
202561|NCT00911027|"~     This is a phase III European multicenter, open label, prospective study to assess the~     diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in~     comparison with the current practice of ultrasound guided systematic biopsy. The trial will~     involve 15-20 European Centers.~   "
202562|NCT00911014|"~     Evaluate access to healthcare, comprehension of pre-operative counseling and post-operative~     goals of women treated for vesicovaginal fistula in Niger through use of a questionnaire.~   "
202583|NCT00910741|"~     The purpose of this study is to determine the recommended dose of NC-6004 according to the~     dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy,~     safety and tolerability.~   "
202563|NCT00911001|"~     Patients that are on total knee/hip replacement initiate prophylaxis treatment on the~     hospital ground. Once they leave the hospital, as outpatients they continue with the~     treatment at least during two consecutive weeks. Patients will be instructed to follow~     treatment recommendations (either LMWH or oral treatment, at physician discretion) and to~     come back to the surgeon after that period. At that visit, the Treatment Satisfaction~     Questionaire with Medication (TSQM) test as well as the Moriski-Green Questionaire (measures~     compliance with medication) will be answer by the patient. TSQM is an self administered~     validated scale (validated also in spanish) that measures in a generic way the treatment~     satisfaction to a treatment. Morinski-Green test will be used to measure the compliance~     degree on medication.~   "
202564|NCT00910988|"~     Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in~     comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men,~     measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production~     (glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of~     disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of~     appearance [Ra]).~      We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in~     insulin sensitivity.~      Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling~     pathways in antipsychotic naïve healthy young men.~      We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in~     insulin signaling.~   "
202565|NCT00910975|"~     The purpose of the study is to investigate if the duration of treatment of hepatitis C with~     pegylated interferon and ribavirin can be individualized on the basis of how fast the~     hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient~     than standard treatment.~   "
202566|NCT00910962|"~     This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to~     evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately~     525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.)~     All subjects will continue to receive the local standard of care for the duration of the~     study.~   "
202567|NCT00910949|"~     The study will investigate characteristics of chronic pain after thoracotomy~   "
202568|NCT00910936|"~     The investigators will evaluate the effects of an endurance exercise program on the physical~     performance, the well being, and indicators of metabolic function in patients with an HIV~     infection.~   "
202569|NCT00910923|"~     This will be a single center study conducted in two parts. Part 1 will assess the safety,~     tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of~     JNJ-38431055 in healthy male volunteers. Part 2 will assess the effect of food on the~     pharmacokinetics of JNJ-38431055.~   "
202570|NCT00910910|"~     The purpose of this study is to determine the safety and efficacy of lenalidomide as a first~     line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will~     compare the effects (good and bad) of lenalidomide with chlorambucil.~   "
202571|NCT00910897|"~     Primary objective:~        -  Compare the complete remission (CR) rates (i.e., the true CR, with negative~          immunofixation) achieved with either four courses of VD or four courses of VTD.~      Secondary objectives:~        -  Compare the following parameters following 4 cycles of VD or VTD induction treatment:~             -  CR rate+ very good partial remission (VGPR) rate~             -  Overall remission rate (CR + VGPR + partial remission (PR) rate)~             -  K/l light chain ratio in patients in CR.~             -  Safety (quality of the sampled stem cells, extrahaematological and haematological~               toxicity: specially neurological toxicity, length of hospitalization).~        -  Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell~          transplantation (ASCT).~   "
202572|NCT00910884|"~     RATIONALE: Natural supplements and a special diet may help rid the body of estrogen and~     testosterone and may slow the growth of tumor cells.~      PURPOSE: The purpose of this randomized Phase I trial is to first IDENTIFY, through~     laboratory analysis and validating cellular biochemical pathways, and HELP CONTROL, using~     natural supplements and a special diet work, extemporaneous and environmental (man-made)~     hormones, hormone impacting compounds and hormone-mimicking compounds that are made outside~     the body, found in manufactured products or in-taken to the body of cancer patients through~     life-style, environmental or consumption products. Patients with early-stage or remission~     stage prostate cancer, breast cancer, or uterine cancer have a much greater sensitivity to~     these extemporaneous hormonal or hormonal influencing compounds.~   "
202573|NCT00910871|"~     The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207~     in combination with an individualized background regimen (BR) of antibacterial drugs as~     treatment for MDR-TB~   "
202574|NCT00910858|"~     The purpose of this study is to assess pharmacokinetic and pharmacodynamic characteristics of~     oral lenalidomide monotherapy administered to patients with Low- or Intermediate-1-risk~     Myelodysplastic Syndrome (MDS).~   "
202575|NCT00910845|"~     The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A~     (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary~     incontinence.~   "
202576|NCT00910832|"~     The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment~     of patients with dyschesia treated by rectal rehabilitation.~   "
202577|NCT00910819|"~     To describe treatment reality of patients with colorectal cancer treated by office-based and~     clinic-based medical oncologists in Germany.~   "
202578|NCT00910806|"~     The purpose of this Phase I, open-label, single sequence drug-drug interaction trial in human~     immunodeficiency virus-type 1 infected patients is to investigate the potential interaction~     between steady-state nevirapine (NVP) 200 mg b.i.d. (twice a day) and a single dose of 400 mg~     TMC207 and to explore the pharmacokinetics (how the drug is absorbed into the bloodstream,~     distributed in the body and eliminated from the body).~   "
202579|NCT00910793|"~     The objective of this study is to evaluate the effect of the combination of formoterol and~     beclometasone dipropionate on central and peripheral airway dimensions in asthmatic patients~     using Computational Fluid Dynamics (CFD). Further more, the effect of this combination~     therapy on exhaled NO, lung function (spirometry, body plethysmography, diffusion and~     resistance) and subjective asthma control score as well as the safety of this combination~     will be assessed.~   "
202584|NCT00910728|"~     This study is being conducted to test study drug AZD1480 to see how it may work to treat~     myeloproliferative diseases. The main purpose of this study is to determine the safety and~     tolerability of AZD1480. This is the first time the drug has been given to humans and is~     classed as a first time in man study. Its main purpose is to establish a safe dosage of the~     drug and provide additional information on any potential side effects this drug may cause.~     The study will also assess the blood levels and action of AZD1480 in the body over a period~     of time and will indicate whether the drug has a therapeutic effect on myeloproliferative~     diseases.~   "
202585|NCT00910715|"~     The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline~     treatment in patients with erythema migrans.~   "
202586|NCT00910702|"~     The purpose of this study is to determine the feasibility, primary safety and efficacy of~     foldable capsular vitreous body (FCVB) in the treatment of retinal detachment.~   "
202587|NCT00910689|"~     The purpose of this study is to determine if the addition of preventive medication, behavior~     migraine management or the combination of preventive medication and behavior migraine~     management improves the outcome of optimal acute therapy for frequent migraines.~   "
202588|NCT00910676|"~     Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the~     beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be~     affected by folliculitis.~   "
202589|NCT00910663|"~     The objective of this study was to compare the oral availability of a test product of~     Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially available~     reference product, CellCept® 250 mg capsule administered to healthy subjects under fed~     conditions.~   "
202590|NCT00910650|"~     The purpose of this phase 2 study is to find the best way to give this new experimental~     regimen and determine if it can treat metastatic melanoma in humans. In this phase 2 study,~     the experimental products are given initially to a group of 8 people. If safe and found to~     have significant anti-tumor activity, it will be given to up to 14 other people, for a total~     of 22 people in this study. Physicians watch subjects carefully for any harmful side effects.~     Although the experimental regimen has been well tested in laboratory and animal studies, and~     a similar regimen has been given to a group of patients at the National Cancer Institute in~     Bethesda, MD, the side effects in people cannot be completely known ahead of time. This~     protocol is offered only to people whose condition cannot be helped by other known~     treatments.~      The study procedures will start with the collection of white blood cells through apheresis (a~     procedure in which blood is drawn from a patient and separated into its components, some of~     which are retained, such as white blood cells, and the remainder returned by transfusion to~     the patient).~      Subjects will be asked to undergo two aphereses, one to make the gene-modified MART-1 TCR~     CTLs and the dendritic cell vaccines, and a second one after the subject receives the gene~     modified cells to later study them in the blood.~      On the day of the first apheresis, subjects will be admitted to the hospital and will receive~     chemotherapy over the next five days which decreases the risk of rejection of the transferred~     cells by the subject's immune system and facilitates their expansion and attack of the~     melanoma lesions. During this time, the gene-modified MART-1 TCR CTLs and the dendritic cells~     will be manufactured in the laboratory from the apheresis product and will be extensively~     tested to assure that they express the appropriate TCR and that they do not contain any~     contaminating bacteria or virus. Then the gene-modified MART-1 TCR CTLs will be given back to~     the subject through a vein in the arm. It will be followed by vaccination with the dendritic~     cells under the skin. During the next fourteen days, subjects will also receive interleukin 2~     (IL-2), which is a standard treatment for patients with metastatic melanoma. During the next~     2 to 3 weeks, subjects will stay in the hospital until the study investigators determine that~     the subject has fully recovered from all of the procedures, and it is safe for the subject to~     go home. Chemotherapy frequently causes a decrease in the platelet or red blood cells, and~     therefore subjects may require platelet and/or red blood cell transfusions.~   "
202591|NCT00910637|"~     This study is examining a birth control patch for 13 cycles (1 year).~   "
202592|NCT00910624|"~     This is a single-arm, multicenter study of boceprevir (BOC) in combination with peginterferon~     plus ribavirin (PEG/RBV) in adult chronic hepatitis C (CHC) genotype 1 participants who~     completed their per-protocol defined treatment and did not achieve sustained viral response~     (SVR) while in the PEG/RBV control arm(s) of an Schering-Plough Research Institute (SPRI)~     study of BOC combination therapy. Participants who are able to enroll in this study within 2~     weeks after the last dose of PEG/RBV in previous protocol are to receive BOC+ PEG/RBV for up~     to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who are not able to~     enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are~     to receive PEG/RBV for 4 weeks followed by BOC+ PEG/RBV for up to 44 weeks, with 24 weeks~     post-treatment follow-up.~   "
202593|NCT00910611|"~     A vibrating cold pack placed proximal to the site of immunization will decrease the pain of~     routine preschool immunizations when compared to standard care.~   "
202594|NCT00910598|"~     This is a study in patients with clinically isolated syndrome (CIS) and early relapsing~     remitting multiple sclerosis (RRMS) to assess the effects of glatiramer acetate (GA)~     subcutaneously on the condition of the optical nerve in comparison to no medicinal therapy~     during 12 months and to assess the use of Optical Coherence tomography (OCT), a non-invasive~     ophthalmological technique, in daily practice as an alternative to magnetic resonance imaging~     (MRI) scanning for follow-up of these patients.~   "
202595|NCT00910585|"~     Asthma among low-income, minority children remains a prime example of health disparities that~     are resistant to change. Demonstrations of reductions in disproportionate hospitalizations in~     controlled trials are limited. We performed a controlled clinical trial of an Asthma Coach to~     reduce hospitalizations among low-income, African American children.~   "
202596|NCT00910572|"~     Rationale: Patients diagnosed with hepatocellular carcinoma (HCC) at an intermediate or~     advanced stage (according to the BCLC classification system) are not amenable of curative~     treatment. According to EASL and AASLD guidelines patients with an intermediate stage HCC are~     treated with trans-arterial chemoembolization (TACE) while patients with an advanced stage~     HCC are treated with molecular targeted drugs or other combinations according to their liver~     function. The median survival expected for patients in intermediate-advanced stages ranges~     from 11 to 20 months.~      Purpose of the Study: The purpose of this prospective phase II study is to determine whether~     or not Radioembolization with Yttrium-90 microspheres (TheraSphere®) provides an anti-tumoral~     effect and a sensible benefit in terms of time-to-progression (TTP) and survival in patients~     with good liver function (Child A-B7) and a confirmed diagnosis of Intermediate or Advanced~     (because of the presence of neoplastic portal thrombosis) Hepatocellular Carcinoma (HCC).~   "
202597|NCT00910559|"~     The purpose of the study is to collect phenotypic (observable characteristics) and genetic~     information about individuals with Autism Spectrum Disorders (ASDs) and their families.~   "
202598|NCT00910546|"~     The purpose of this study is to quantify the variation in tumour middle position during a~     course of stereotactic body radiotherapy (SBRT), and thereby be able to design radiotherapy~     margins that takes into account the full motion span throughout an entire course of SBRT.~   "
202603|NCT00910481|"~     This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP)~     in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the~     rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who~     are managed without planned insertion of IABP.~   "
202604|NCT00910468|"~     This is a retrospective, case-control study of 75 patients having undergone a~     robotic-assisted laparoscopic myomectomy were compared to patients having undergone~     myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI~     or on final pathology report. Charts were reviewed for surgical and post-operative variables~   "
202605|NCT00910455|"~     This is the first study of SRX246 in humans, and is being conducted to begin to establish a~     safety profile of orally administered SRX246.~   "
202606|NCT00910442|"~     The aim of this study is to investigate the responses of the serum amyloid A (SAA) pathway to~     dietary supplements of glutamine (Gln) and cysteine (Cys) together with methionine~     (Met)-overloading in HIV+ patients comparatively to healthy controls.~   "
202607|NCT00910429|"~     Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348)~     will be asked to participate in this long term extension study with BAY63-2521. The aim of~     the long term study is to collect additional information to evaluate the safety and~     tolerability of BAY63-2521. Patients will be treated with open label medication on their~     individual optimal dose between 0,5 mg - 2,5 mg tid.~   "
202608|NCT00910416|"~     The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic~     parameters. Nowadays it can be evaluated by several monitoring methods, derived from~     electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton,~     USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical~     Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring~     modalities during anesthesia.~   "
202609|NCT00910403|"~     The Presbyopia Algorithm subject to this study has been specifically developed to~     prospectively generate a treatment file for the Technolas 217z100 laser that will provide~     Presbyopia correction among eyes with primary hyperopia or hyperopic astigmatism (distance~     correction). The treatment algorithm provides a bilateral, multifocal ablation with a center~     near addition, thereby allowing good focus over a range of object distances.~   "
202610|NCT00910390|"~     This randomized study compares three different freezing methods to store human in vitro~     fertilization (IVF) embryos: vitrification with two commercial kits or slow freezing. After~     information, all patients undergoing IVF treatment can be included in the study. If~     qualified, embryos at different developmental stages will be allocated between the three~     methods. At the end of the first year survival and developmental rates, and implantation and~     pregnancy rates will be analyzed in order to determine the best method.~   "
202611|NCT00910377|"~     The purpose of this study is to determine whether counseling sessions on breastfeeding for~     adolescent mothers and their grandmothers in the maternity ward and at home are effective in~     to improve the exclusive and total breastfeeding rates during the first six month, as well as~     the convenient timing of supplementary feeding introduction.~   "
202612|NCT00910364|"~     The purpose of this pilot study is to assess the feasibility of determining the effects of a~     structured exercise program started two to four weeks after diagnosis of a first episode~     lower-extremity deep vein thrombosis (DVT) for a period of 12 weeks in reducing the incidence~     of post-thrombotic syndrome (PTS).~   "
202613|NCT00910351|"~     Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate~     antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This~     planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation~     Powder in the pediatric population of 6 to 12 years of age.~   "
202614|NCT00910338|"~     Stress urinary incontinence is the most common type of female incontinence. The efficacy of~     pelvic floor muscle training with biofeedback has been already proved in many studies. But~     intravaginal probe is one of the limitation. So, the purpose of this study is to assess the~     efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.~   "
202615|NCT00910325|"~     To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to~     cholecystectomy and to establish a description of this novel translumenal technique in humans~     at this institution.~   "
202616|NCT00910312|"~     The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system~     (a system that freezes tissues), is safe and effective in the treatment of benign breast~     tumors such as fibroadenoma.~   "
202617|NCT00910299|"~     To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse~     cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after~     successful implantation of coronary drug-eluting stents.~      To determine the adverse event profile of prasugrel in patients with high platelet reactivity~     on clopidogrel after implantation of coronary drug-eluting stents.~      To determine the effect of prasugrel on inhibition of platelet activation in patients with~     high platelet reactivity on clopidogrel.~   "
202618|NCT00910286|"~     Objective: To compare termination criteria (TC) of pressure support ventilation (PSV).~      Design: Randomized cross-over clinical trial.~      Setting: Intensive Care Units.~      Patients: Sixteen patients on PSV with ability to answer a visual analog scale (VAS).~      Protocol and Measurements: Each patient was ventilated with two different TC ventilators,~     fixed and automatic, with measurements of ventilatory mechanic variables, breathing comfort~     and asynchrony patterns.~   "
202619|NCT00910273|"~     Study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation~     in AS, and whether etanercept can modify the intima-media thickness (IMT) in these patients~   "
202620|NCT00910260|"~     We plan to investigate the serum elevation of 25(OH)D under UVB nb and UVA1 therapy, in order~     to determine the effect of these nowadays frequently used wavelengths for phototherapy on~     vitamin D plasma levels. We hope for a better understanding of steady-state and~     treatment-induced levels of vitamin D changes to better recognize the impact of phototherapy~     on vitamin D synthesis in the skin, the dimension of vitamin D production to be expected in~     the course of standard phototherapy and a potential gap in vitamin D production compared to~     physiological needs which then should be supplemented orally.~   "
202621|NCT00910247|"~     This is a long term, open-label, safety extension study in subjects with partial onset~     seizures.~   "
202622|NCT00910234|"~     Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in~     preterm infants. Inflammation, hypoxia-ischemia, free oxygen radical formation and~     excitotoxicity are all known pathogenic mechanisms that mediate this injury. Erythropoietin~     (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries.~     During the past decade, recombinant human Epo (rhEpo) has been widely used in preterm infants~     to prevent or treat the anemia of prematurity, in general, rhEpo has been considered to be~     safe and well tolerated in preterm infants. EPO was considered not capable of passing through~     blood-brain-barrier at low dose. Evidence from animal experiments reveals that rhEpo must be~     given in high doses at the beginning or within a short (up to 6 hours), critical time period~     after the onset of brain injury to achieve a significant neuroprotective effect. A recent~     study using high-dose rhEpo (3000 U rhEpo/kg body weight at birth) for neuroprotection in~     very preterm infants revealed that no signs of adverse effects of early high-dose rhEpo~     treatment in very preterm infants were identified. Contrary to this, a recent study in PVL of~     a rat model revealed that using a low dose rhEpo (50-100 U/kg) was effective in the treatment~     of brain damage induced by hypoxia-ischemia and did not affect normal oligodendrocyte~     maturity. On this basis, the researchers intent to investigate (1) whether low-dose rhEpo~     (100 U/kg) or high-dose rhEpo (3,000 U/kg) given to very preterm infants (gestation age < 32~     weeks) immediately after birth and subsequently during the first 2 days is safe and possesses~     neuroprotective properties;(2) whether there are gender differences in response to the~     hypoxia-ischemic insult and EPO treatment; (3)the pharmacokinetics of low dose and high dose~     rhEPO. Very preterm infants with gestational age of < 32 weeks and admitted to the NICU are~     eligible for enrollment.~   "
202623|NCT00910221|"~     Acute kidney dysfunction is common after cardiac surgery. While many patients suffer no~     long-term ill effects from post-operative kidney dysfunction, some require initiation of~     dialysis therapy that can contribute to long-term morbidity. Further, there is evidence to~     suggest that those patients requiring dialysis after cardiac surgery have a higher risk of~     death in hospital.~      The exact reasons why some patients develop acute kidney dysfunction after cardiac surgery is~     not well understood. However, research evidence to date has suggested that the presence of~     co-morbid illnesses (i.e., diabetes mellitus) and exposure to cardiopulmonary bypass~     (heart-lung machine used during operation when heart is stopped). Cardiopulmonary bypass, in~     particular, has been shown to over-activate several aspect of the body's immune system. Such~     over-activity can induce oxidative stress and contribute to acute kidney dysfunction.~      The investigators believe that the statin drug, atorvastatin, might reduce the oxidative~     stress that occurs during cardiopulmonary bypass, and thus, prevent or reduce the magnitude~     of acute kidney dysfunction in those patients at highest risk. The investigators hope to give~     atorvastatin (40 mg orally) to patients immediately prior to and for 3 days after cardiac~     surgery, and to compare the effects on kidney function with patients who have not had~     atorvastatin.~      Atorvastatin is the most commonly prescribed medication in Australia and is used to reduce~     blood cholesterol levels and decrease the risk of heart attacks and stroke. Recently,~     however, it has been discovered that atorvastatin may be useful for prevention of~     inflammation and oxidative stress in other conditions, such as following cardiac surgery with~     cardiopulmonary bypass.~      Thus, the investigators plan to examine whether atorvastatin can prevent acute kidney~     dysfunction. This trial as planned is a pilot study. If atorvastatin shows promising evidence~     of reduction in acute kidney dysfunction, further studies on a larger scale would be required~     to justify its general use.~      The investigators plan to determine whether atorvastatin, a statin drug, possesses kidney~     protective effects in patients at risk for perioperative acute kidney dysfunction after~     cardiac surgery and exposure to cardiopulmonary bypass.~      This is a pilot, randomized, blinded, placebo-controlled trial.~      The investigators plan to administer atorvastatin (40 mg orally) or placebo to patients~     immediately prior to and for 3 days after cardiac surgery. The atorvastatin/placebo will be~     given orally either by orogastric tube after induction of anaesthesia or swallowed by the~     patients.~      Whether a particular patient receives the atorvastatin or placebo will be decided at random,~     and neither the patient nor the investigators will be aware of the allocated treatment.~      The investigators plan to measure kidney function before and after cardiac surgery using the~     standard blood tests. The investigators also plan to measure markers of inflammation and~     oxidative stress in the blood. This may give insight into the mechanisms whereby atorvastatin~     exerts its effects. The investigators will also take four 20 ml samples of blood, spaced~     before, and after the operation, from the arterial catheter routinely inserted in every~     patient undergoing cardiac surgery.~      The investigators believe that there will be no significant additional risk to a patient who~     participates in the study, and no discomfort other than that normally associated with cardiac~     surgery. Informed consent will be obtained from the patient prior to the operation by one of~     the investigators or the ICU research nurse. The clinical care of a patient who does not~     consent for any reason will not be affected.~   "
202624|NCT00910208|"~     The aims of this study are to assess efficacy and safety of patient-controlled analgesia~     (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety~     of two PCA dosing regimens.~   "
202625|NCT00910195|"~     Between 2%-4% of adult population suffers from obstructive sleep apnea (OSAS)(1), which is~     characterized by obstructive snoring, repetitive apnea and hypopnea in sleep, repetitive~     cyclic oxygen saturation, as a result from sleep fragmentation related to the arousals in~     sleeping profile and clinical consequences like day drowsiness, neuropsychological deficits,~     raised danger of accidents and cardiovascular disease. (1-6). The therapy of choice is the~     application of nasal continuous positive airway pressure (CPAP) (7-9).~      Increasing relevance obtain the combined sleep-related breathing disturbances, where the~     patient shows an obstructive sleep apnea syndrome and some central breathing disturbances in~     the polysomnography at night. Those patients frequently present with cardiovascular diseases.~     These combined night breathing disturbances are frequently insufficient to be mitigated~     exclusively with a CPAP therapy.~      Some modifications of nCPAP therapy were developed in order to optimize the~     therapy-compliance and the effectiveness of the therapy. Bi-level-CPAP-devices produce two~     pressure levels: one for inspiration and another for expiration, so that the patients are~     able expire against a constant low pressure. An increase in the use of this application in~     comparison between the conventional or the automatic CPAP therapy could not be proved in~     early studies. (12, 13) The principle of the automatic nCPAP therapy is to recognize the~     patient's current need of pressure and to alter the pressure within a set range by applying~     different algorithms. Some studies have shown that this therapy increased compliance and~     comfort (14-16), while other studies could not confirm these results. (17, 18)~      The result of the current study should prove if the treatment of a new algorithm therapy~     based on an automatic bi-level-system for patients with sleep-related respiratory disorders~     is as effectively and subjective more comfortable as the conventional CPAP therapy.~      Patients with a particularly high need of pressure should experience a clear expiratory~     pressure relief and a higher comfort. Therefore a better compliance is to expect. In the same~     way patients with additional central respiratory disturbances should obtain a benefit from~     the bi-level modus. This new treatment would help particularly such critical patients, who~     are not responding well to the CPAP therapy or find it uncomfortable.~   "
202626|NCT00910182|"~     Retrospective study in order to investigate the outcome after conservative (with or without~     transcatheter arterial embolization) and surgical treatment of splenic injuries.~   "
202627|NCT00910169|"~     The objective of this research is to evaluate the efficacy of five different in-patient~     treatment modalities and predictive factors of outcome for anorexia nervosa. The primary~     hypothesis is that the different treatment types impact outcome of patients at discharge from~     inpatient treatment and at one year follow-up, even after adjustment for confounding factors~     (age, length of illness, number of previous hospitalizations, clinical state at intake).~   "
202628|NCT00910156|"~     Comparison of ease and convenience of nasotracheal intubation with the use of the two~     indirect laryngoscopes, Airtraq or Glidescope, versus the traditionally used Macintosh~     laryngoscope.~   "
202629|NCT00910143|"~     Total mesorectal excision (TME) is a rather new operation technique in the treatment of~     rectal cancer. It is known to reduce the rate of local recurrences. However, the influence on~     long-term survival is unclear.~   "
202630|NCT00910130|"~     The purpose of this study is to determine whether Retinol binding protein 4 has a role in~     insulin resistance development in patients suffering from end stage renal disease on~     hemodialysis.~   "
202631|NCT00910117|"~     The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in~     patients with locally advanced HNSCC. The hypothesis is that the response would be increased~     with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.~   "
202632|NCT00910104|"~     The purpose of this study is to determine whether Omegaven is effective in the treatment of~     parenteral nutrition associated liver disease (PNALD).~   "
202633|NCT00910091|"~     This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA)~     on progression free survival (PFS) in post menopausal patients with endometrial cancer.~   "
202634|NCT00910078|"~     The purpose of this study is to evaluate the predictive role of free Kappa/Lambda ration in~     Multiple Myeloma post-transplant.~   "
202635|NCT00910065|"~     The objective of this study is to investigate whether intravenous administration (injected~     into a vein) of acetylsalicylic acid (Aspirin) in doses of 250 and 500 mg is superior to oral~     treatment of ACS with tablets containing 300 mg of Aspirin.~   "
202636|NCT00910052|"~     Background: Post-operative wound complications arise in as many as 50% of kidney transplant~     recipients. Fibrin sealants have been used in many areas of surgery in attempt to reduce the~     accumulation of post-operative fluid collections with varying success. The use of fibrin~     products has been proposed as a means of reducing local wound complications in the~     immunocompromised renal transplant recipient but as yet has not been studied.~      Methods: 145 patients were enrolled and 141 patients were randomized (74 Tisseelä fibrin~     sealant, 67 No Tisseelä fibrin sealant) in a prospective manner to receive fibrin sealant or~     not at the time of their renal transplant. Patients were analyzed per the randomization~     assignment. The operating team was blinded to the decision until after the iliac fossa~     dissection was complete. The sealant was applied via aerosol to the iliac fossa and renal~     allograft hilum after completion of the neoureterocystostomy in 5 ml quantity. Clinical and~     radiographic data were reviewed through the usual 8-week follow-up transplant ultrasound.~     Patients in whom the peritoneum was entered were excluded from data analysis. The incidence~     of lymphocele, wound infection, dehiscence, clinically significant hematoma as defined by~     necessitating incision and drainage, and urine leak was recorded.~   "
202659|NCT00909753|"~     The objective of this study was to evaluate the comparative bioavailability between Ursodiol~     500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference)after a single-dose in~     healthy subjects under fed conditions.~   "
202637|NCT00910039|"~     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib malate works after stereotactic~     radiosurgery in treating patients with newly diagnosed brain metastases.~   "
202638|NCT00910026|"~     The aim of the present study is to evaluate the effect of low (6 ml/kg) and high (12 ml/kg)~     tidal volume ventilation on inflammatory and oxidative stress biomarkers in the exhaled~     breath condensate (EBC) of ICU patients without lung injury. As the analysis of EBC is~     reflecting the composition of epithelial lining fluid (ELF), the study of EBC pH and~     inflammatory and oxidative stress markers could have the potential for assessing lung~     inflammation caused by mechanical ventilation. This study also aims to look at the~     possibility to identify selective profiles of biomarkers that might have a prognostic and/or~     diagnostic value in the follow up of these patients.~   "
202639|NCT00910013|"~     Total knee replacement is a painful procedure. Many solutions have been proposed to diminish~     the post-operative doses of narcotics, including nerve blocks.~      The purpose of the study is to compare if the adjunction of intra-articular ropivacaine to a~     femoral block is more effective on narcotics consumption than the block alone after TKR.~   "
202640|NCT00910000|"~     This trial is a Phase Ib/II study of carboplatin/gemcitabine/vorinostat for the treatment of~     platinum sensitive recurrent ovarian cancer. The carboplatin and gemcitabine combination is~     an FDA approved regimen for platinum-sensitive recurrent ovarian cancer. Vorinostat is a type~     of drug called a histone deacetylase inhibitor (HDAC inhibitor). HDAC inhibitors interact~     with chromosomes in the cancer cell and cause cancer cells to stop growing. Vorinostat has~     shown a decrease in the amount of ovarian cancer cells growing in the laboratory and also may~     enhance the anti-cancer effects of carboplatin.The purpose of the Phase Ib study is to~     determine the highest dose of the drug vorinostat that can be given safely in combination~     with carboplatin and gemcitabine. Not everyone who participates in this research study will~     receive the same dose of the study drug, vorinostat, but carboplatin and gemcitabine doses~     are held constant. Vorinostat doses depend on previous enrollment and tolerability. The~     expansion Phase II study uses the vorinostat dose found in the Phase Ib study in combination~     with carboplatin/gemcitabine and as a single agent maintenance therapy to better understand~     toxicity and efficacy.~   "
202641|NCT00909987|"~     Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy~     (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with~     CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic~     Resonance Imaging.~   "
202642|NCT00909974|"~     Low birth weight (LBW; birth weight<2,500g) is the most important determinant of mortality~     and morbidity in the neonatal period. It is also a very important factor in predicting~     nutritional status, health and development in childhood. It even influences health in adult~     life, contributing to the vicious cycle of disease and poverty. The high rate LBW in DCs~     represents therefore a major public health problem. Maternal chronic energy deficiency is~     assumed to be a major determinant of the problem in these countries along with prenatal~     micronutrient deficiencies. A large body of recent evidence points out that multiple~     micronutrient supplementation as such has only a modest beneficial effect on fetal growth.~     Therefore, it is expected that providing these multiple micronutrients in a food supplement~     covering energy requirement needs of pregnant women will have an effect of public health~     importance on children's health.~      This study has the objective of improving children's health by improving birth outcome and~     fetal growth through the provision of a food supplement enriched in multimicronutrients~     during pregnancy.~      This research includes 2 constituents:~        1. a pilot phase during which dietary behavior of pregnant women is assessed as a component~          for optimal fetal growth~        2. a randomized, placebo-controlled trial, including 1300 pregnant women aimed at testing 2~          hypotheses: supplementing pregnant women with a food supplement containing a~          multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a~          positive effect on health and growth during infancy.~      The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz,~     which plays a leader role in research and services providing at the district level and in~     policy recommendations at the national level. This will ensure that the study findings are~     incorporated into on-going district programs with possible replication at the national level.~     The research lasts from February 2006 to August 2009.~   "
202643|NCT00909961|"~     This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical~     markers of bone in post-menopausal osteoporotic patients aged between 50-65.~   "
202644|NCT00909948|"~     The proposed study is based on our observation of paradoxical tumor regression after~     rejection of the donor graft in conjunction with the results of our murine experiments. We~     hypothesize that clinically meaningful responses can be achieved in patients with advanced~     malignancies with a transplant strategy using nonmyeloablative conditioning and related~     mismatched donor stem cell transplant where the intention will be to initially achieve mixed~     chimerism which will be followed by recipient lymphocyte infusion (RLI) in an attempt to~     deliberately reject the donor graft. This will lead to the development of novel transplant~     strategies for achieving antitumor effects without the risk of graft versus host disease~     (GVHD). This proposed protocol is a Pilot Study that will evaluate the safety of this~     outpatient transplant strategy, i.e., establishment of initial mixed chimerism followed by~     RLI for donor graft rejection, in patients with advanced lymphomas, and multiple myeloma.~      In addition, because RLI have been reported to reverse ongoing GVHD, this approach might~     potentially reverse GVHD while achieving antitumor responses if this complication~     unexpectedly occurs.~   "
202645|NCT00909935|"~     This study is designed to identify the plasma concentrations which are required to achieve~     adequate sedation, using a Ramsay Sedation Scale. As an alpha 2 agonist, dexmedetomidine can~     elicit hemodynamic changes, fluctuations in blood pressure and heart rate. This study will~     attempt to determine whether these changes can be predicted by plasma concentrations.~   "
202660|NCT00909740|"~     This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A~     administered by IV infusion to patients with advanced solid tumors for whom standard therapy~     either does not exist or has proven to be ineffective or intolerable.~   "
202661|NCT00909727|"~     The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects~     with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis~     transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective~     potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators~     are pharmacological agents that increase the chloride ion transport properties of the channel~     in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA)~     activation.~   "
202662|NCT00909714|"~     Testing the hypothesis that non-invasive brain stimulation by transcranial direct current~     stimulation (tDCS) combined with functional training in the subacute phase of first-ever~     stroke will enhance functional regeneration compared with a Placebo intervention.~   "
202646|NCT00909922|"~     The aim of this study was to identify posture asymmetries in transfemoral amputees utilizing~     clinical evaluation measures. The purposes of this investigation were: 1) to measure the limb~     length indirectly to determine the proportion of participants with LLD and to quantify the~     mean amount of discrepancy. The investigators hypothesized that a majority of transfemoral~     amputees would present with a short prosthetic limb. 2) To measure pelvic tilt to determine~     if transfemoral amputees undergo musculoskeletal adaptations similar to those reported in the~     literature. The investigators hypothesized that transfemoral amputees would present with a~     greater degree of anterior pelvic tilt and pelvic innominate asymmetry than what has been~     previously reported. 3) To assess restriction in lateral trunk flexion and hip extension to~     determine if asymmetry was present and if it was related to the increase in anterior pelvic~     tilt. The investigators hypothesized that restrictions would be found in the lateral trunk~     flexors and hip flexors on the amputated side contributing to posture asymmetry at the~     pelvis. 4) To determine if musculoskeletal adaptations at the pelvis were affected by~     prosthetic limb length, lateral trunk flexion and hip extension restrictions, and residual~     limb length. The investigators hypothesized that the previously reported posture asymmetries~     would contribute to musculoskeletal adaptations at the pelvis and trunk. Results of the~     present study will provide a reference for clinicians when using clinical evaluation measures~     to determine the presence of posture asymmetries in transfemoral amputees. If posture~     asymmetries are detected, clinicians need to determine musculoskeletal structures at fault~     and offer treatment solutions to prevent secondary impairments.~   "
202647|NCT00909909|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy in different ways may kill more tumor cells. Giving it after surgery may kill any~     tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how~     well it works in treating women with early stage breast cancer.~   "
202648|NCT00909896|"~     This study is being done to evaluate the efficacy of robotic approach for staging of~     endometrial cancer as compared to an equivalent abdominal approach. The primary objective is~     to measure and compare postoperative pain at rest at several time points between two groups~     of patients undergoing either robotic or open laparotomy approach for staging of endometrial~     cancer.~   "
202649|NCT00909883|"~     Foot dystonia is frequently observed in patients suffering from Parkinson'disease. It is~     characterized by an abnormal involuntary movement which is very uncomfortable (difficult to~     walk) and painful for the patient.~      Botulinum toxin injections seem to be efficient to treat this dystonia. However studies on~     this topic are few and very imprecise (many muscle injected, especially the Flexor digitorum~     longus, different doses used, heterogeneous population with many types of dystonia included,~     open studies).~   "
202650|NCT00909870|"~     This study randomly assigns patients with venous leg ulcers to receive standard therapy~     (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live~     human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they~     heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for~     three months in order to assess patients for longer term safety.~   "
202651|NCT00909857|"~     To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on~     alleviating complaints of dysmenorrhea associated with oral contraceptive use.~   "
202652|NCT00909844|"~     The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to~     the proportion of children who maintain a regression or stabilisation of sexual maturity~     until the end of the study.~   "
202653|NCT00909831|"~     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving hydroxychloroquine together with temsirolimus may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of hydroxychloroquine~     when given together with temsirolimus in treating patients with metastatic solid tumors that~     have not responded to treatment.~   "
202654|NCT00909818|"~     The purpose of this study is to investigate the difference in late radiation morbidity~     between hypofractionated and standard fractionated breast irradiation given to women operated~     with breast conservation for early breast cancer.~   "
202655|NCT00909805|"~     Inguinal incisions are the most frequent incisions used in children before the acquisition of~     continence (180 incisions per year for the Pediatric Surgery Department in Nice CHU).~     However, healing of those wounds can be made hard because of soiling induced by urine and/or~     stool, which is unavoidable in case of wearing nappies.~      Nowadays, in order to overcome a possible contamination of the surgical wound, post-surgery~     wound dressing is protected by the application of a waterproof band aid (like Tegaderm®)~     during wound-healing (evaluated to a mean of 7 days). When the band aid is soiled, a nurse~     changes it, causing unpleasantness in low age children (whose epidermal fragility is well~     known), and sometimes parents worry.~      Moreover, those occlusive wound dressings avoid any control of the surgical wound during~     healing phase.~      At the end of the wound-healing time, wound dressings are removed, causing discomfort for~     children and necessity of a qualified nurse staff at visit times.~      Cutaneous use glues, introduced in surgery more than 10 years ago, allow making waterproof~     and transparent sutures, with a firmness equivalent to a 2/0 string suture (cutaneous suture~     in children is made with 5/0) and has its own local antiseptic properties. It does not need~     to be covered by any wound dressing during wound-healing phase. Moreover, cosmetic results~     for the 2-octyl-cyanoacrylate in the adult and children series (without any precise age~     distinction) seem to be equivalent to conventional sutures. Finally, its application goes~     with time saving (in preoperative and during wound-healing phase) and increases comfort for~     patients.~      The aim of this study is to evaluate the efficiency of cutaneous use glue Dermabond®~     (2-octyl-cyanoacrylate) in surgical inguinal incisions sutures in children before the~     acquisition of continence, by a non-inferiority randomized multicentric prospective study.~      Two patient groups will be studied, the sutures of one control group will be made with a~     conventional technique (intradermic surjet surgical suture), and one patient group will be~     sutured with 2-octyl-cyanoacrylate. The principal evaluation criteria is the suture quality~     (short- and long-term cosmetic aspect) evaluated by the surgeon.~      Two secondary criteria will be studied :~        -  Parental satisfaction~        -  Ease of clinical nursing management Each studied criteria will be evaluated by a numeric~          score.~   "
202656|NCT00909792|"~     The objective of this trial is compare the visual performance, ratings, and preference of two~     multifocal, soft contact lenses.~   "
202657|NCT00909779|"~     This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice~     daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation~     will consist of a total of 6 visits over approximately 1 year.~   "
202658|NCT00909766|"~     The purpose of this study is to evaluate the safety, tolerability and effect on body weight~     and other obesity-related factors of different doses of BMS-830216, compared to placebo. The~     study will also determine the amount of BMS-830216 in the blood.~   "
202663|NCT00909701|"~     Surgical patients are usually starved for 8 to 12 hours before operation in order to reduce~     the chances of vomiting and other complications during the anaesthetic. Recent studies have~     suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the~     body before the operation. To avoid these harmful effects of starvation, patients are now~     given carbohydrate drinks (sugar-containing drinks that provide energy for the body) up to 2~     hours before the operation. These drinks have been shown to make patients feel better, reduce~     sickness after the anesthetic/surgery and result in quicker recovery from operation. But the~     ways in which the sugar drinks have these beneficial effects on the body are unknown. The~     optimum time of giving these drinks to patients before operation is also unknown. This study~     will investigate the hormone responses of the body, following intake of 2 different~     carbohydrate drinks, in order to determine the optimum time of intake of these drinks in~     order to obtain the maximum benefits for the body.~   "
202664|NCT00909688|"~     To determine the safety, tolerability, and drug absorption profile of multiple IV doses of~     BLI 489 in healthy subjects.~   "
202665|NCT00909662|"~     RATIONALE: Gathering information over time from women undergoing chemotherapy for breast~     cancer may help doctors learn more about mental and physical fatigue caused by treatment.~      PURPOSE: This clinical trial is studying fatigue caused by chemotherapy in women who have~     undergone surgery for stage I, stage II, or stage III breast cancer and in healthy~     volunteers.~   "
202666|NCT00909649|"~     This study was carried out from January 2005 to December 2007 at Mansoura university~     hospital. Fifty patients who had breast cancer were included in the study, MRM was done for~     all patients. Patients were randomly divided into two groups. Group І with fibrin glue 4ml of~     fibrin glue was sprayed on the surgical area with Y canula and group П without fibrin glue.~     Preoperative, Operative and Postoperative data were collected including postoperative~     measurement of drainage, date of removal of the drain, state of the wound, incidence of~     Seroma formation.~   "
202667|NCT00909636|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects.~   "
202668|NCT00909610|"~     The objective of this study was to evaluate the comparative bioavailability between Ursodiol~     500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference) after a single-dose in~     healthy subjects under fasting conditions.~   "
202669|NCT00909597|"~     This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and~     tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus~     inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin~     combination therapy. After an initial screening period, patients will be randomized to one of~     3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4~     weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of~     pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target~     sample size is 500+ individuals.~   "
202670|NCT00909584|"~     This is a multicenter Phase 2 randomized parallel-group study to determine the effect of~     Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or~     enter an observation period with an option to crossover to Telintra treatment in a 1:1~     allocation.~   "
202671|NCT00909571|"~     Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with~     Tacrolimus based immunosuppressive regimens.~   "
202672|NCT00909558|"~     The purpose of this study is to assess the safety and effectiveness of natural killer (NK)~     cell and natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with~     metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous~     cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.~   "
202673|NCT00909545|"~     The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable~     and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.~   "
202674|NCT00909532|"~     The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects~     with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic~     fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective~     CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein.~     Potentiators are pharmacological agents that increase the chloride ion transport properties~     of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.~   "
202675|NCT00909519|"~     This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3~     parallel-groups, monocentric study. The primary objective is to evaluate the effect of~     naproxcinod on the renal function when co-administered with furosemide in comparison to~     naproxen and placebo.~   "
202676|NCT00909506|"~     The investigators hypothesize that adjuvant metformin use in breast cancer patients with~     overweight or pre-diabetes mellitus (DM) may improve their body condition including weight~     loss.~      In this study, the investigators aim to test the efficacy and safety of adjuvant metformin~     for operable breast cancer patients with overweight or pre-DM.~   "
202677|NCT00909493|"~     The proposed Nova Scotia Chronic Pain Collaborative Care Network (NSCPCCN) is a professional~     development partnership between family physicians and chronic pain and addiction specialists~     designed to build capacity in the health care system and provide improved pain management to~     patients. The NSCPCCN will provide community physicians with access to chronic pain and~     addiction specialists to assist in the management of patients with chronic pain. The current~     project is designed as a pilot project to determine the feasibility of a this program on a~     large scale. In order to determine the effect of implementation of a mentor- mentee network~     in the primary care setting, a pilot project will be undertaken. The study will assess the~     impact of the NSCPCCN on treatment of chronic pain and opiate management in two communities~     in Nova Scotia prior to a proposed province wide rollout of the program.~   "
202678|NCT00909480|"~     This trial is conducted in Asia, South America and the United States of America (USA).~      The aim of this clinical trial is to determine whether two insulin treatments given once~     daily are equally effective with respect to the blood glucose lowering effect in subjects~     with type 2 diabetes inadequately controlled on metformin treatment with or without an~     additional anti-diabetic drug (OAD).~   "
202720|NCT00908921|"~     To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD~     initiation mono-therapy in type 2 diabetic patients in China.~   "
202679|NCT00909467|"~     Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for~     pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these~     conditions is not known. The effects of pulmonary hypertension on the clinical picture and~     the symptoms of patients in these conditions needs also further exploration. This exploratory~     study is designed to describe the prevalence of pulmonary hypertension in the population with~     such hematologic diseases, and the stages of pulmonary hypertension as well its effect on~     exercise capacity at time of diagnosis.~   "
202680|NCT00909454|"~     The purpose of this study is to determine if 14-19 year old African American adolescents are~     able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose~     of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.~   "
202681|NCT00909441|"~     Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node~     positive breast cancer.~      Objectives of the study:~      Primary objective~      1. Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with~     positive nodal disease, proven by ultrasound guided fine needle aspiration, following~     neoadjuvant chemotherapy.~      Secondary objectives~        1. Evaluate the technical success of sentinel node biopsy following neoadjuvant~          chemotherapy.~        2. Evaluate the accuracy of clinical examination and ultrasound examination of the axilla~          in identifying the presence of residual disease in the axilla following neoadjuvant~          chemotherapy in biopsy proven node positive breast cancer patients.~      Number of patients:~      N = 300~      Population:~      Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that~     present with biopsy proven positive axillary nodes.~      Study duration:~      From February 2009 to February 2012 - 3 years~   "
202682|NCT00909428|"~     Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more~     bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy~     continues to surround the term 'urgency' and there is no good tool to evaluate the severity~     of urgency. This fact has constrained the performance of clinical research in this field. The~     cause of urinary urgency is not fully understood and may vary from patient to patient.~      Although clinicians regularly obtain measures of bladder sensation during cystometry, little~     attention has been paid to the patient experience of urinary urgency. In this study, the~     researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary~     urgency in women with overactive bladder.~   "
202683|NCT00909415|"~     This study will examine the effects of spinal cord abnormalities on perioperative~     neurovesical dysfunction in patients with anorectal abnormalities.~   "
202684|NCT00909402|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923~     administered in combination with Cisplatin and Capecitabine as first-line therapy in subjects~     with inoperable metastatic gastric, gastroesophageal or esophageal adenocarcinomas.~   "
202685|NCT00909389|"~     This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe~     + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.~   "
202686|NCT00909376|"~     Many pregnant women have an ultrasound done of their fetus in the beginning of the second~     trimester of pregnancy. Some have a transvaginal sonography while others have a~     transabdominal one, depending on clinical parameters such as weight, scars etc. In the~     transvaginal ultrasound there is some amount of version of the fetus done by the examiner to~     maintain a better aspect of the fetus, while this is not done in a transabdominal sonography.~      The objective of this trail is to determine whether having a transvaginal ultrasound as~     opposed to a transabdominal one has an association to adverse perinatal outcomes.~   "
202687|NCT00909363|"~     The purpose of this project is to describe the pathophysiology of thrombocytopenia and~     bleeding in patients with Wiskott-Aldrich Syndrome (WAS) and determine the response to~     thrombopoietic agents in vitro and in vivo.~   "
202688|NCT00909350|"~     This is a laboratory-based, exploratory study using tissue obtained from our clinical~     practice. The purpose of this study is to confirm our ability to characterize miR expression~     in various tissues (proximal and distal esophagus, stomach and duodenum) obtained from the~     upper gastrointestinal tract in preparation for the study of MiR in patients with Barrett's~     esophagus and other inflammatory conditions of the upper gastrointestinal tract.~   "
202689|NCT00909337|"~     Exercise-induced increase of the pulmonary arterial pressure may be an early sign of~     pulmonary arterial hypertension. It has been shown that patients with normal pulmonary~     arterial pressure at rest but elevated pulmonary arterial pressure during exercise have a~     decreased exercise-capacity and may have a worse prognosis compared to patients with normal~     pulmonary arterial pressure values at rest and during exercise. According to the currently~     used definition pulmonary hypertension can be diagnosed if the mean pulmonary arterial~     pressure is higher than 25mmHg at rest or 30mmHg during exercise. In this study patients with~     a risk for pulmonary arterial hypertension (connective tissue disease) and increased~     pulmonary arterial pressure values during exercise are receiving a therapy with a dual~     endothelin receptor antagonist - bosentan, a therapy established for pulmonary arterial~     hypertension. The therapy effect is than compared to the recorded changes before the~     introduction of this therapy.~   "
202690|NCT00909324|"~     This study is designed to assess the tolerability and comfort of peri-operative 0.3%~     hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3%~     hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to~     control (no pre-operative lubricant).~   "
202691|NCT00909311|"~     The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and~     tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in~     healthy volunteers.~   "
202692|NCT00909298|"~     The purpose of this study is to determine if post-operative administration of intrinsic~     pathway antagonist (TTP889) in patients on Left Ventricular Assist Device (LVAD) support will~     result in a 50% reduction of thrombin generation markers at 28 days compared to placebo.~   "
202721|NCT00908908|"~     The purpose of this study is to determine the metabolism and elimination of carbon-14 labeled~     eribulin acetate (14C-eribulin) in patients with advanced solid tumors.~   "
202761|NCT00908388|"~     The primary objective of this study is to determine the safety and efficacy of the GORE~     Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects with acute~     complicated type B aortic dissection.~   "
202693|NCT00909285|"~     Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and~     neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific~     features, such as atrophy, which is a late feature in the progression of the disease.~     Therefore, developing new approaches for early and specific recognition of Alzheimer disease~     at the prodromal stages is of crucial importance.~      In the present study the investigators would like to examine if combined treatment with TMS~     and cognitive training (CoTra) for several weeks can produce a sustained improvement in~     cognitive and behavioral symptomatology of Alzheimer's disease (AD) patients. A number of in~     vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects~     of neuroanatomy, chemistry, physiology, and pathology, hold promise.~   "
202694|NCT00909272|"~     Can an ultrasound machine be used to perform a diagnostic lumbar medial branch block?~   "
202695|NCT00909259|"~     The purpose of this feasibility study is to determine the effect of stimulating the phrenic~     nerve to treat periodic breathing (a pattern of breathing characterized by hyperpneas~     followed by hypopneas or apneas). Clinically, these physiologic events translate into sleep~     fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly~     ventricular arrhythmias.~      Stage 1 of the study is acute in nature, such that subjects will undergo the placement of a~     stimulation lead, followed by assessment of stimulation of the phrenic nerve using the lead~     for up to 2 nights of sleep. A sensing lead may also be placed during the initial implant~     procedure. Observational data will be obtained and stimulation provided using an externalized~     system connected to the study leads. Following the study, all investigational components will~     be removed from the patient.~      Stage 2 of the study is being conducted at one of the participating sites to determine the~     initial safety of chronic stimulation of the phrenic nerve in a limited number of patients~     with sleep disordered breathing. It is anticipated that data obtained in this feasibility~     study will show that the proposed intervention can modify respiration with a low incidence of~     adverse effects. The results of this trial are intended to be used to develop a subsequent~     protocol for a multi-center study of chronic phrenic nerve pacing.~   "
202696|NCT00909233|"~     This investigation targets either the patients of 18 years-old or older and under 65~     years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient~     efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg.~     This investigation will be limited to the patients whose tolerability of Levitra 10mg is~     judged to be no problem.~   "
202697|NCT00909220|"~     This study will determine how people with depression differ from healthy people in brain~     activity and interpreting emotions, both before and after receiving a psychotherapy~     treatment.~   "
202698|NCT00909207|"~     The scientific aim of this study is to evaluate patient comprehension of the 77 newly~     developed items as well as the extent to which the items correspond to the concepts of~     interest for each patient reported outcome (PRO).~      A secondary aim of this study is to evaluate the usability of the technology interface for~     collecting the PRO data of the PRO-CTCAE system once it has been built to accommodate the~     learning garnered during the cognitive interviews.~   "
202699|NCT00909194|"~     The purpose of this study was to identify clinical characteristics and estimate the~     prevalence of Juvenile Primary Fibromyalgia in a female inpatient psychiatric population. The~     secondary purpose of this study was to determine the efficacy of an intervention~     (psychoeducational seminar and relaxation technique) on reducing the symptoms of Juvenile~     Primary Fibromyalgia Syndrome. We looked at the short-term and long-term effects of this~     intervention in comparison to the control (skin care seminar).~   "
202700|NCT00909181|"~     The primary objective of the double-blind phase of the study is to compare the effects of two~     doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to~     evaluate the extended safety and skin-irritation profile of topically administered oxybutynin~     gel.~      The hypothesis is that topically administered oxybutynin gel will decrease (compared to~     placebo) the number of incontinence episodes per week, average daily urinary frequency, and~     urinary urgency; increase average urinary void volume; and improve patient quality of life.~   "
202701|NCT00909168|"~     This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for~     treatment of newly diagnosed AML patients, younger than 66 years.~      Trial is based on:~        -  INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).~        -  CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC~          (HDAC)~        -  INTENSIFICATION: Allo-BMT, ASCT~        -  MAINTENANCE: AraC~           a) Primary endpoints:~        -  Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.~        -  RFS, DFS and OS.~           b) Secondary endpoints:~        -  Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression~          and monitoring.~        -  Evaluation of prognostic clinical relevance of biological features at onset.~        -  Feasibility and outcome of consolidation with BMT.~   "
202702|NCT00909155|"~     Do functional brain changes occur during Venlafaxine ER (extended release) versus Fluoxetine~     treatment and do changes in selective structures, such as the amygdala, predict treatment~     response?~   "
202703|NCT00909142|"~     The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in~     patients with proven bone metastases.~   "
202704|NCT00909129|"~     The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV~     and determine how these responses are affected by HCV treatment and correlates to response.~     Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment,~     and correlate this to treatment outcome.~   "
202705|NCT00909116|"~     Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic~     constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel~     frequency and the feeling of not having emptied the rectum. ODS is usually associated with~     internal rectal prolapse and/or rectocele. For surgical treatment of ODS, a plethora of~     surgical techniques have been described with no one method having been assessed as a gold~     standard.~   "
202706|NCT00909103|"~     The aim of the study is to assess elastography during EUS examinations of focal pancreatic~     masses, and to consequently differentiate benign versus malignant pancreatic masses in a~     prospective multi-center design.~   "
202762|NCT00908375|"~     The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain~     in patients who present with radicular pain due to a herniated disc, spinal stenosis or~     failed back surgery syndrome.~   "
202707|NCT00909090|"~     The purpose of this study is:~      I. To measure MP optical density (MPOD) spatial profiles in two groups (experimental and~     placebo) of 50 subjects each (N = 100), during an L + Z supplementation period of 12 months.~      II. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will~     result in significantly improved visual performance under disability glare conditions.~      III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will~     result in significantly reduced photostress recovery times.~      IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will~     result in improved contrast enhancement.~   "
202708|NCT00909077|"~     In this study we want to investigate if combination therapy with rituximab (R) +~     dexamethasone (DXM) is superior to monotherapy with DXM in patients with newly diagnosed~     idiopathic thrombocytopenic purpura (ITP). Before treatment molecular studies - gene~     expression profiling - are performed to characterize at the molecular level those patients~     responding adequately to the treatment as compared to those obtaining a minor or no~     responses.~      The hypothesis is that combination therapy is superior to monotherapy as defined above. Using~     gene expression studies up-front the hypothesis is that this method may be able to predict~     the response to treatment.~   "
202709|NCT00909064|"~     The investigators hypothesize that Arixtra patients will be less likely to experience wound~     infection than patients who have received low-molecular weight heparin, coumadin or aspirin~     with mechanical compression.~   "
202710|NCT00909051|"~     Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in~     a large sample of patients.~   "
202711|NCT00909038|"~     It is a national, retrospective , observational study in hypertensive patients treated for at~     least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25~     mg. The primary objective is to assess the control rate (systolic and diastolic blood~     pressure). Key secondary objectives are to assess the blood pressure reduction after at least~     8 weeks of treatment, describe the population treated with this new fixed dose combination~   "
202712|NCT00909025|"~     Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal~     adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill~     cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular~     cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of~     this phase I study is to establish safety, toxicity and maximal tolerable dose of a single~     infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and~     gastric adenocarcinoma~   "
202713|NCT00909012|"~     Patients with phenylketonuria (PKU) have an inborn error in the metabolism of the amino acid~     phenylalanine (Phe) and thus must follow a strictly controlled protein-restricted diet from~     early infancy. This protein-restricted diet is devoid of natural dietary sources of n-3 long~     chain polyunsaturated fatty acids (LC-PUFA), such as eggs, meat, milk or fish. Therefore,~     blood concentrations of n-3 LC-PUFA, especially of docosahexaenoic acid (DHA) are reduced in~     PKU children compared to healthy controls. DHA availability is considered important for~     optimal neurological function. Previous studies have shown that neural function of PKU~     children is improved by high dose supplementation of fish oil providing DHA, as shown by~     significant improvements of both visual evoked potential latencies and of fine motor skills~     and coordination, but no dose response relationship has been established so far.~      This multicentric double-blind randomized trial aims at determining quantitative DHA~     requirements for optimal neural function in PKU children. Patients with classical PKU from~     several major treatment centers in Europe will be randomized to receive between 0 and 15 mg~     of DHA per kg body weight daily for a duration of 6 months. Biochemical (fatty acid~     composition of plasma phospholipids, lipoprotein metabolism and metabolic profiles), and~     functional testing (visual evoked potentials, fine motor skills, cognitive function and~     markers of immune function) will be performed at baseline and after 6 months. Intake per kg~     body weight will be related to outcome parameters and thus a possible dose response~     relationship will be defined. The results from this study are expected to contribute to the~     improvement of the diet of PKU patients, but they also have the potential to help defining~     quantitative DHA needs of healthy children.~      The primary hypothesis is that supplementation with DHA improves visual function in children~     with PKU.~   "
202714|NCT00908999|"~     This is a three year fMRI study conducted at the University of Wisconsin (UW) Hospital and~     the William. S. Middleton VA Hospital. This study is guided by the hypothesis that reduced~     fMRI activity and connectivity cortical midline structures (i.e., medial frontal and ventral~     posterior cingulate cortex) are physiologic abnormalities that relate strongly to the~     compromised insight into cognitive deficits, or anosognosia, shown by a subset of individuals~     with amnestic MCI (aMCI) and AD. Further, the investigators hypothesize that these regional~     changes in fMRI activity are predictive of faster progression from aMCI to AD.~   "
202715|NCT00908986|"~     The objective of this study is to assess the as efficacy of rituximab as induction therapy in~     membranous lupus nephritis. Safety and tolerability will additionally be assessed. Subjects~     will receive open-label 2 courses of rituximab at baseline and at 6 months. They will be~     followed monthly for 18 months to assess response and durability of response.~      The hypothesis: B cell depletion will be an effective safe and well tolerated treatment for~     membranous lupus nephritis (Class V).~   "
202716|NCT00908973|"~     The aim of the study is to describe differences in meal-stimulated gut hormone response,~     appetite and intestinal transit time between good and poor responders 1-2 years after Gastric~     Bypass surgery for obesity.~   "
202717|NCT00908960|"~     Research studies have shown a strong association between cancer and blood clots in the veins~     (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary~     embolism) which in severe cases may be life threatening. The purpose of this research study~     is to see if enoxaparin is effective in preventing blood clots in the veins in participants~     who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also~     have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are~     small particles that are generated from different types of blood cells in the body. In people~     who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk~     factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots~     in patients after abdominal or orthopedic surgery and in patients who suffer from a severe~     medical illness. Based on these studies, we are investigating to see if it prevents~     thrombosis in people with certain types of cancer.~   "
202718|NCT00908947|"~     The objectives of this study are to collect post-market confirmatory evidence of the safety~     and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular~     Stent System (together the LifeStent® Vascular Stent System).~   "
202719|NCT00908934|"~     The aims of this study are to compare the blood levels achieved with a new formulation of~     AZD9056 to an existing formulation of AZD9056 used in previous studies.~   "
202722|NCT00908895|"~     The treatment of extra-articular distal radius fractures is still controversial. In Canada,~     most patients with unstable fractures are treated with pinning and cast. Results are often~     associated with shortening and lack of function.~      The purpose of the study is to compare stabilization with a radio-radial fixator to the usual~     method, suggesting that the radio-radial fixator will provide more strength at 6 months~     follow-up.~   "
202723|NCT00908882|"~     The goal of this study is to improve the effectiveness of tobacco cessation treatment for~     veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care~     management approach using telehealth and motivational interviewing counseling. Both tobacco~     dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare~     system.~   "
202724|NCT00908869|"~     Purpose:~      This phase I trial estimates the antiangiogenic and antivascular effect of 4 different levels~     of continuous low doses of the combination of Vinorelbine, Cyclophosphamide and Interferon~     alpha 2b ( metronomic chemotherapy )in adult advanced neoplasm.~      This study is non randomized, monocentric, and with a pharmacodynamic part.~      Primary objective:~      Estimation of the toxicity of the combination of continuous low doses of Vinorelbine,~     Cyclophosphamide and Interferon alpha 2b.~      Secondary objectives:~      Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography~     (DEC-MRI), biology and immunohistochemistry of the treatment.~   "
202725|NCT00908856|"~     This study will examine the safety of two different cellular therapies in the treatment of~     stroke.~   "
202726|NCT00908843|"~     The purpose of this study is to compare the efficacy of oral versus intravenous hydration in~     the prevention of the contrast-induced nephropathy.~   "
202727|NCT00908830|"~     Lung transplantation is a life saving procedure for patients with a terminal lung disease~     such as cystic fibrosis. Approximately, one in 3,500 children in the United States are born~     with cystic fibrosis each year with the predicted survival reaching 36.9 years in 2006.~     Cystic fibrosis was the third lead indication for lung transplantation in 2006. Cystic~     fibrosis is a genetic disease that can affect the way the body can remove salt from various~     organs. It results in mucus blocking the ducts of the lungs and pancreas leading to inability~     to handle oxygen and malabsorption of nutrients. Malabsorption is a common complication of~     cystic fibrosis that can affect the way the anti-rejection medications are absorbed. One~     medication that is utilized after transplant to prevent rejection is mycophenolate mofetil.~     This medication may not be absorbed adequately in this population due to their disease thus~     placing these patients at increased risk of rejection. At the investigators' institution, all~     transplant patients are initiated at the same mycophenolate dose regardless of their~     underlying disease. The limited available literature regarding cystic fibrosis transplant~     patients and mycophenolate suggests that these patients require higher doses due to their~     erratic absorption. The purpose of this study is to evaluate the effects of mycophenolate~     mofetil on the body in lung transplant patients who have cystic fibrosis in efforts to~     improve survival outcomes.~   "
202728|NCT00908817|"~     The purpose of this study is to determine whether triamcinolone paste applied over tracheal~     tube is effective to reduce the incidence of postoperative sore throat after tracheal~     intubation.~   "
202729|NCT00908804|"~     The aim of this prospective randomized trial is to compare the feasibility of open with~     laparoscopic appendectomy in suspected acute appendicitis. The investigators especially~     focused on the postoperative recovery and long-term complications.~   "
202730|NCT00908791|"~     Conjugated Linoleic Acid (CLA) is obtained in the human diet by consumption of foods~     containing ruminant fat. Milk and dairy products have shown the highest amounts of CLA.~     Clarinol (CLA), is considered a natural supplement and is not regulated by the Food and Drug~     Administration (FDA). CLA is known to inhibit proliferation of human breast cancer cells and~     tumors in rodent breast cancer models and reduced Spot 14 (THRSP, S14) and Fatty Acid~     Synthase (FASN) gene expression in breast cancer cells and tht the two major CLA isomers used~     in nutritional supplements (C9, t11 and t10, c12) were equipotent in reducing breast cancer~     cell growth. This study looks at the hypothesis that S14 expression is decreased by CLA and~     will characterize the major pharmacodynamic (PD) effects of CLA in newly diagnosed Breast~     cancer patients on Tumor tissue lipogenic pathway. FASN, S14 and Lipoprotein Lipase (LPL),~     Ki67 and apoptotic index expression will be assessed by quantitative immunohistochemistry~     (IHC) in initial breast cancer biopsies and compared to that in resected breast tumor tissue~     after the study subject has been taking CLA for ten to twenty-eight days. Tissue from~     adjacent breast adipocytes will also be analyzed to determine whether adipose tissue effects~     can serve as a surrogate marker for those in tumor tissue. A sample of the original biopsy~     will be compared to the tumor resection sample to determine the levels of CLA in the breast~     cancer cells.~   "
202731|NCT00908778|"~     The purpose of this study is to determine the safety and efficacy of Vitreosolve® in diabetic~     retinopathy patients.~   "
202732|NCT00908765|"~     Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise~     intolerance are ventilatory limitation leading to deconditioning and inactivity. So far it is~     poorly understood which form of exercise is the most effective in training this condition.~     The investigators want to study the physiological response to two different training programs~     (High intensity aerobe interval training and moderate continuous aerobe training)with special~     focus on cardiac and skeletal muscle adaptions~   "
202733|NCT00908752|"~     The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive~     brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive~     matched placebo with TACE therapy.~   "
202734|NCT00908739|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at tumor tissue samples from patients who have~     undergone surgery for localized kidney cancer.~   "
202748|NCT00908557|"~     The principle objective of this randomised controlled trial is to assess whether an~     improvement in lexico-syntactic readability combined with adherence to French recommendations~     for good practice in writing the Information and Consent Form (ICF) given to patients~     participating in clinical trials, increases their understanding of the information compared~     to conventional written information, in real (not simulated) conditions.~   "
202735|NCT00908726|"~     AquafolTM (Daewon Pharmaceutical Co., Ltd., Seoul, Korea) is a microemulsion propofol that~     has been developed for eliminating lipid solvent-related adverse events of long chain~     triglyceride emulsion (LCT) propofol (Diprivan®; AstraZeneca, London, United Kingdom), such~     as infection, fat embolism, hypertriglyceridemia and pancreatitis. Originally, AquafolTM was~     formulated with 8% polyethylene glycol 660 hydroxystearate (Solutol HS 15, BASF Company Ltd.,~     Seoul, Korea) and 5% tetrahydrofurfuryl alcohol polyethylene glycol ether (Glycofurol, Roche,~     Basle, Switzerland). A phase 1 study to assess the safety and tolerability of polymeric~     vehicles of this formulation in healthy volunteers showed dose-limiting toxicity.~     Subsequently, it was reformulated with 10% purified poloxamer 188 (PP188) as a nonionic block~     copolymer surfactant and 0.7% polyethylene glycol 660 hydroxystearate as a nonionic~     surfactant. Alterations in propofol formulation may result in altered pharmacokinetic,~     pharmacodynamic characteristics.~      The aim of this study was to compare the pharmacokinetics and pharmacodynamics of propofol~     microemulsion and lipid emulsion, using noncompartmental analysis and population analysis~     with mixed effects modeling.~   "
202736|NCT00908713|"~     The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy~     in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the~     study is that glucocorticoids can modulate the excessive inflammatory response in patients~     with severe CAP without any significant side effects, showing a benefit in the percentage of~     non-response to the empiric antimicrobial treatment.~   "
202737|NCT00908700|"~     A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in~     50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring~     cardiopulmonary bypass with additional risk factors for late stroke.~      Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best~     medical therapy as per guidelines.~      Main research questions:~        1. Can successful occlusion of the LAA be safely achieved by cut and sew or stapler~          techniques?~        2. In patients with atrial fibrillation with 2 or more risk factors for stroke, will~          removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of~          systemic embolic events and major bleeding compared to warfarin?~   "
202738|NCT00908687|"~     This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be~     enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this~     study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high~     dose) on Day 0 with or without a patch (low or high dose).~   "
202739|NCT00908674|"~     Androcur is an antiandrogenic drug, which blocks the action of male sex hormones. Androcur is~     used for treatment of advanced prostate cancer. This study investigates the effect of~     Androcur on quality of life of prostate cancer patients who are taking the drug for 12 months~   "
202740|NCT00908661|"~     The purpose of this study is to determine if a mesh is effective in the prevention of a~     parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.~   "
202741|NCT00908648|"~     Narrow band imaging (NBI) is an imaging technique that allows a better definition of~     capillary pattern and improves the contrast between adenomas and the surrounding mucosa.~     Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the~     impact of NBI is being tested in several screening scenarios. The investigators evaluated~     whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of~     screening colonoscopy improved adenoma detection.~   "
202742|NCT00908635|"~     This study is designated to determine serum concentrations of inflammatory mediators Ang-1,~     Ang-2, Ang-1/Ang-2 ratio, and Tie-2 in patients with sepsis-induced MODS and to investigate~     the association among increased permeability, inflammatory mediators, and these serum~     mediators in development of organ failure.~   "
202743|NCT00908622|"~     The purpose of this study is compare the improvement in global and regional cardiac function~     measured by echocardiography and magnetic resonance in patients with old myocardial~     infarction subject to cardiac catheterisation with percutaneous endocavity implantation of~     autologous myoblasts.~   "
202744|NCT00908609|"~     The investigators propose to validate the utility of their novel hybrid imaging technique for~     accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer~     treatment and predicting treatment efficacy. The investigators' unique hybrid technique is~     implemented by simultaneously deploying near infrared (NIR) optical sensors and a commercial~     ultrasound (US) transducer mounted on a hand-held probe, and utilizing co-registered lesion~     structure information provided by ultrasound to improve the optical tomography.~      As a result, the optical tomography assisted with US has overcome problems associated with~     intense light scattering and has provided reliable tumor angiogenesis distributions. Initial~     results with a small group of patients who underwent biopsy have shown that early stage~     invasive cancers present two-fold greater total hemoglobin concentration on average than~     fibroadenomas and other benign lesions. Initial results of advanced cancers have shown that~     the angiogenesis distribution is highly distorted and heterogeneous, and the distorted~     distributions correlate with histological microvessel density counts and can be used to~     assess chemotherapy response.~      The objective of this study is to validate the investigators' initial results that NIR light~     guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.~   "
202745|NCT00908596|"~     Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging~     (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to~     participate.~      The administration of contrast agents that contain gadolinium such as Primovist/Eovist might~     increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis~     (NSF) in patients with renal impairment. This study is to assess the potential risk to~     develop NSF in patients with renal impairment after the administration of Primovist/Eovist.~      Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan~     which was prescribed by the referring doctor. After the MRI scan the patient will be included~     in a two year follow-up period to assess if signs or symptoms suggestive of NSF have~     appeared.~   "
202746|NCT00908583|"~     To determine if deletional strategies will provide effective desensitization.~   "
202747|NCT00908570|"~     The purpose of this Phase I study is to investigate and document the effects of local~     treatment with a topical estriol cream on the vaginal environment of pre-menopausal women.~   "
202749|NCT00908544|"~     This is a multi-center, open-label, non-randomized proof-of-concept trial. Two cooperating~     HIV-specialized centres represented by Dr. med. Hans Jaeger and Prof. Dr. Johannes Bogner are~     planning to perform an IIT (investigator initiated trial) with the goal to eradicate HIV in~     N=40 HIV-infected patients with either primary infection or chronic infection and successful~     HAART (Highly Active Antiretroviral Treatment) of several years.~      All patients will be started on a multi-drug HAART including two~     Nucleoside-Reverse-Transcriptase-Inhibitors (NRTI´s), one Protease-Inhibitor (PI), a~     CCR5-inhibitor and an Integrase-Inhibitor (INI). Decay of viral reservoirs like latently~     HIV-infected CD4+ T-cells will be monitored over time.~   "
202750|NCT00908531|"~     The hypothesis to be addressed in this randomized phase III trial is that 4 months of~     letrozole may be superior to surgery as primary therapy for early stage hormone receptor~     positive breast cancer in postmenopausal women, provided that these patients will receive~     definitive and radical surgery and adjuvant therapies as otherwise indicated at the~     completion of preoperative letrozole.~   "
202751|NCT00908518|"~     The progressive aging of the general population cause increase in number of extensive and~     long surgeries in older patients. Age is a risk factor for perioperative myocardial ischemia~     and Postoperative Cognitive Dysfunction (POCD) The suggested study will deal with the~     above-mentioned complication in patients older then 65 years undergoing major non-cardiac~     surgeries.~      It has been shown that Isoflurane and sevoflurane may have a cardio-protective effect after~     cardiac surgery involving cardio-pulmonary bypass, and it was recommended that isoflurane~     should be used in these cases. A question was raised but haven't been answered yet, whether~     this cardio-protective effect exists also in non-cardiac major surgery.~      The aim of this study is to evaluate whether there is a difference in the occurrence of~     postoperative cognitive dysfunction and perioperative myocardial ischemia between total~     intravenous anesthesia using propofol and isoflurane based anesthesia.~   "
202752|NCT00908505|"~     The purpose of this study is to compare the effectiveness of different mucous clearance~     techniques in cystic fibrosis patients~   "
202753|NCT00908492|"~     The purpose of this study is to pilot the home Environmental Skill-Building Program (ESP) and~     an educational control intervention with persons with dementia and their caregivers (n=40) in~     preparation for a larger double-blind randomized controlled trial. Caregivers of persons with~     dementia often deal with difficult behaviors. The ESP is an occupational therapy intervention~     that helps caregivers adapt to their environment and build care-giving skills. The areas~     addressed include changes to the home set-up, adaptive equipment, instruction in strategies~     of problem-solving, energy conservation, safe task performance, and fall recovery techniques.~     A trial is needed with methodological rigor and to determine if the intervention is feasible~     in the Canadian health care system. Results will contribute to understanding how caregivers~     and people with dementia can be supported in their home environments.~   "
202754|NCT00908479|"~     This study would focus on a new method of adding extra leg homework exercises to the usual~     therapy delivered in the hospital. We propose to design an exercise program for the affected~     leg that would be given to the client as homework and done in the client's hospital room or~     ward. The program would be designed and monitored by a therapist that works in the hospital.~   "
202755|NCT00908466|"~     The purpose of this study is to find out about the safety and effectiveness of the study~     drug, sirolimus, in patients with uveitis and to utilize the potential effectiveness of~     sirolimus, and yet to avoid the potential complications of systemic use of the drug. In this~     study, the investigators will administer sirolimus either around (subconjunctival injection)~     or inside the eye (intravitreal injection). Local administration of sirolimus to the eye is~     not expected to have effects on the rest of the body. Therefore, it may offer a safer way~     than the current methods used to control the inflammation caused by non-infectious uveitis.~   "
202756|NCT00908453|"~     The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered~     fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who~     are requiring a loading dose of phenytoin.~   "
202757|NCT00908440|"~     The purpose of this study is to examine the effects of a decision aid on veterans with~     posttraumatic stress disorder (PTSD) presenting for care. The investigators' primary~     hypothesis is that patients assigned to use the decision aid will demonstrate improved~     quality of decisions regarding PTSD treatment relative to patients assigned to usual care.~     Improved decision quality will be examined by assessing patient's knowledge of treatments,~     evaluation of the risk and benefits, ability to arrive at a decision, and certainty about~     that decision. The investigators' secondary hypothesis is that patients assigned to the~     decision aid will be more satisfied with their care and more compliant with their care~     compared to patients assigned to receive usual care. The investigators will also determine~     whether patients assigned to the decision aid, relative to patients assigned to usual care,~     are more likely to receive evidence-based treatments for PTSD and experience reductions in~     PTSD symptoms.~   "
202758|NCT00908427|"~     The purpose of this study is to compared the efficacy of 80W KTP photoselective laser~     vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in~     reducing the volume of prostate and relieving the obstruction in men with benign prostatic~     hyperplasia (BPH) on non-randomized controlled design.~   "
202759|NCT00908414|"~     The purpose of the study is to determine the safety, tolerability, and plasma~     pharmacokinetics (i.e., the levels of TMC589337 and TMC589354 circulating in your blood over~     time) of increasing single oral doses of TMC589337 and TMC589354 and of multiple increasing~     oral doses followed by a single dose of TMC310911 to assess the potential boosting effect on~     the latter compound. In this study 3 investigational new drugs are involved. These new~     investigational drugs called TMC589337 and TMC589354 (from the PEPI family) and TMC310911 are~     in process of development for the treatment of Human Immunodeficiency Virus-Type 1 (HIV-1).~     TMC589337 and TMC589354 are novel molecules with no antiviral activity to be used to enhance~     the pharmacokinetics profile of a drug. TMC310911 is a novel and potent compound and belongs~     to a medication class called protease inhibitors (PI).~   "
202760|NCT00908401|"~     Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid~     procedural pain in preterm neonates.~      The objective is to test this hypothesis in a randomized, controlled study using a~     standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each~     two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from~     80% with oral sucrose to 40% with breastmilk.~   "
202763|NCT00908362|"~     Airway dendritic cells (DCs) play a key role in smoke-related lung diseases. In this study,~     the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in~     smokers. The researchers hypothesize that fluticasone and salmeterol impact on the number and~     the characteristics of airway DCs in smokers.~   "
202764|NCT00908349|"~     Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine~     Extended-Release (OXC XR)~   "
202765|NCT00908336|"~     Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition~     of erlotinib to chemotherapy has not achieved better results in the general population.~      However, several preclinical and phase I studies have shown that a sequential treatment of~     erlotinib and chemotherapy could avoid a possible negative interaction between both drugs~     when administrated concomitantly, and therefore, it could improve the benefit of the~     combination therapy.~      This study will investigate if the intermittent treatment of a chemotherapy drug, such as~     docetaxel, with erlotinib could achieve a clinical benefit.~   "
202766|NCT00908323|"~     HVTN 908 is a sub study of the HIV vaccine trial, HVTN 205. The purpose of this sub study is~     to better understand how a person's immune system responds to vaccines, particularly HIV~     vaccines. More specifically, researchers will determine whether early responses in the immune~     system help predict strong and long-lasting immunity.~   "
202767|NCT00908310|"~     This will be an international, multi-center, post-marketing surveillance study in patients~     with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI.~     Omniscan will be administered intravenously at the medical discretion of the prescribing~     physician.~   "
202768|NCT00908297|"~     The purpose of this study is to determine the safety and tolerability of the dietary~     supplement Coenzyme Q10 in hemodialysis patients.~   "
202769|NCT00908284|"~     People infected with HIV are now living longer lives because of the use of highly active~     antiretroviral therapy (HAART). However, HAART medications have been shown to increase the~     risk of cardiovascular disease and metabolic dysfunction in adults. More research is needed~     on the effect of HAART in children. The purpose of this study is to assess cardiovascular~     risk factors in children infected with HIV who receive HAART medications and to determine the~     effectiveness of an exercise program on cardiovascular outcomes in these children.~   "
202770|NCT00908271|"~     The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.~   "
202771|NCT00908245|"~     To evaluate the accuracy of ischemic preconditioning (IPC) as a protective maneuver against~     ischemia/reperfusion lesion in patients undergoing major liver resection with intermittent~     portal triad Clamping (IPTC).~      Summary Background Data: For sake of safety and to avoid excessive blood loss during~     parenchymal transection, vascular inflow occlusion is an effective trick but may cause~     ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver~     disease. IPTC has been proven to be superior to continuous hepatic pedicle clamping as it~     preserve liver remnant from severe ischemia/reperfusion lesion, so does IPC. Yet, if IPC is~     beneficial if liver resection is performed under IPTC has never been demonstrated in a~     randomised controlled trial (RCT). The investigators designed a RCT to assess the impact of~     IPC in patient undergoing major liver resection with intermittent vascular inflow occlusion.~   "
202772|NCT00908232|"~     The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide~     or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that~     have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma~     is the second most common cancer of the blood. Bortezomib disrupts the life cycle of the~     cell, affecting numerous biologic pathways, including those related to growth and survival of~     cancer cells.~   "
202773|NCT00908219|"~     The purpose of this study is to determine the effectiveness of using Bevacizumab in the~     prevention of recurrent malignant ascites.~      Ascites is a debilitating and unpleasant complication of several types of cancer. Animal and~     laboratory studies have shown that tumor cell production and/or increases in the amount of~     Vascular Endothelial Growth Factor (VEGF) is a major cause of the formation of malignant~     ascites. Therefore, giving patients with malignant ascites a drug that targets and~     neutralizes VEGF should prevent the recurrence of malignant ascites following paracentesis (a~     procedure to remove fluid from the abdominal cavity).~   "
202774|NCT00908206|"~     This study will compare the effects of GSK598809 and placebo in alcohol dependent volunteers.~     A placebo is a pill with no drug in it (i.e. dummy drug) but it is made to look exactly like~     the real drug.~      Subjects will be given one dose of GSK598809 during one visit and placebo during the other~     visit. These dosing visits will be at least 1 week apart. The study is randomised, which~     means that a computer programme will decide by chance (like tossing a coin), the order in~     which subjects will receive GSK598809 or the placebo, or in other words, whether they will~     receive GSK598809 or placebo first.~      The study is blinded, which means the subjects will not know whether they are receiving study~     drug or placebo first and neither will the doctors at the institute. If necessary for reasons~     of safety, the study staff can find out exactly what the subject has received.~      The study will last for approximately 4 weeks but could be up to 6 weeks, depending on length~     of time between screening and dosing. From screening the subjects will be alcohol-abstinent,~     they may be put on medication for treatment of withdrawal symptoms and then will have at~     least 7 days without any medication before beginning the study medication. During the study~     the subjects will be inpatients at the Central Institute of Mental Health. All subjects will~     be required to fill out questionnaires, perform behavioural tasks and undergo MRI and~     functional MRI (fMRI) scans.~   "
202775|NCT00908193|"~     The aim of this study is to prove the superiority of the robotic assistance in laparoscopic~     repair of abdominal wall hernias .~      In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce~     the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.~   "
202858|NCT00907088|"~     Iron depletion in young children is common and may progress to iron deficiency anemia which~     is associated with irreversible neurodevelopmental effects. Efforts to prevent iron depletion~     are key to preventing these effects. In a recent study of 150 young children (12 to 38~     months), we found that bottle fed children were almost three times as likely to be iron~     depleted compared with cup fed children (37% vs 18%). Thus, we hypothesize that an~     educational intervention designed to encourage timely bottle weaning will lead to a reduction~     in iron depletion.~   "
202776|NCT00908180|"~     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of~     cancer cells. It may also stop the patient's immune system from rejecting the donor's stem~     cells. Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them~     or deliver cancer-killing substances to them without harming normal cells. When the healthy~     stem cells from a donor are infused into the patient they may help the patient's bone marrow~     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving cyclosporine before and after the transplant may stop this from happening. Once the~     donated stem cells begin working, the patient's immune system may see the remaining cancer~     cells as not belonging in the patient's body and destroy them (called graft-versus-tumor~     effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may~     boost this effect.~      PURPOSE: This phase II trial is studying the side effects of giving carmustine together with~     etoposide, cytarabine, melphalan, and alemtuzumab followed by donor stem cell transplant and~     to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma.~   "
202777|NCT00908167|"~     This is a Phase I study that determines a tolerable combination of sorafenib, when given~     sequentially with cytarabine and clofarabine and determines the feasibility of administering~     this drug combination in patients with relapsed or refractory hematologic malignancies~     including acute myeloid leukemia (AML), acute promyelocytic leukemia (APL), acute~     lymphoblastic leukemia (ALL), infantile leukemia (both either AML and/or ALL). AML with prior~     myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms, and~     biphenotypic leukemia.~   "
202778|NCT00908154|"~     GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in~     animal models.~      This study is being conducted to obtain information regarding the safety, tolerability and~     pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy~     male or female subjects. In addition, the effect of food on the pharmacokinetics of~     GSK1014802 will be investigated.~   "
202779|NCT00908141|"~     RATIONALE: Colony stimulating factors, such as GM CSF, may increase the number of immune~     cells found in bone marrow or peripheral blood. It is not yet known which GM-CSF regimen is~     more effective in treating patients with prostate cancer.~      PURPOSE: This randomized phase II trial is studying how well GM-CSF works in treating~     patients with relapsed prostate cancer.~   "
202780|NCT00908128|"~     The objective of this study was to evaluate the comparative bioavailability between~     Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg Tablets (reference), after a~     single-dose in healthy subjects under fed conditions.~   "
202781|NCT00908115|"~     The purpose of this study was to investigate the following questions through post-marketing~     surveillance:~        -  Unknown/Unexpected adverse events and the serious adverse events.~        -  The circumstances in which the adverse events occurred under the practical application.~        -  Factors considered to have influence on safety.~        -  Factors considered to have influence on efficacy.~        -  Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known~          due to the inherent problems of the drugs.~   "
202782|NCT00908102|"~     The purpose of this study is:~        -  Epidemiological part: characteristics of low back pain patients from a forestry company~          in Finland. Data is collected from occupational health databases and self administered~          questionnaires.~        -  Intervention: To determine the effectiveness and cost-effectiveness of several different~          interventions in subacute low back pain (LBP) patients in occupational health (OH).~   "
202783|NCT00908089|"~     The FIN-RACo trial is an investigator initiated multicenter (n=15 centers in Finland)~     prospective study on the treatment of patients with early rheumatoid arthritis (RA) with~     combination therapy with disease modifying antirheumatic drugs starting with methotrexate,~     sulphasalazine, hydroxychloroquine and prednisolone (COMBI). During the first 6 months, the~     patients are randomized to treatment with infliximab/placebo added on the combination~     treatment. The study is prospective for 5 years, with extension to 10 years. The target is to~     induce remission in both treatment arms. To reach this target, the investigators use frequent~     changes of doses and anti-rheumatic drugs and use of intra-articular glucocorticoid~     injections. The primary endpoints are the proportions of patients with remission at 2 and 5~     years in both treatment arms.~   "
202784|NCT00908076|"~     The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe~     and effective for chronic constipation, will also improve constipation symptoms in~     Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in~     bowel movement consistency, quality of life and motor symptoms.~   "
202785|NCT00908063|"~     The primary objective of this study is to evaluate the safety and tolerability of a single~     administration of Oxycyte in patients with severe non-penetrating traumatic brain injury~     (TBI).~      In the first dose level (Cohort 1), 11 patients were randomized 2:1 to receive either 1.0~     mL/kg Oxycyte (0.6 g/kg; n=8) or NS (n=3). A total of 8 patients received Oxycyte. The Data~     Safety Monitoring Board (DSMB) reviewed the safety data for patients in Cohort 1 through Day~     14, and approved escalation to the next dose.~      In Cohort 2, 18 patients will be randomized 2:1 to receive either 2.0 mL/kg Oxycyte (1.2~     g/kg; n=12) or NS (n=6). The DSMB will then review the safety data for all patients in Cohort~     2 through Day 14 and either approve escalation to the highest dose or remain at the current~     dose. If remaining at the current dose level (Cohort 2) an additional 50 patients will be~     randomized 1:1 to Oxycyte (n=25) or NS (n=25) and treated.~      If escalation occurs to Cohort 3, 18 patients would be randomized 2:1 to Oxycyte (n=12) or NS~     (n=6) to receive the 3.0 mL/kg dose. The DSMB would again review the safety data and decide~     whether to treat an additional 50 patients at this dose or to decrease the dose back to 2.0~     mL/kg. This group would be randomized 1:1 to receive Oxycyte (n=25) or NS.~   "
202786|NCT00908050|"~     The purpose of this study is to determine whether botulinum toxin helps patients with~     bruxism.~   "
202859|NCT00907075|"~     The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with~     and without energy restriction.~   "
202926|NCT00906152|"~     A prospective study to assess the association between the change in quality of sleep and the~     change in intensity of pain in Spanish patients seen for subacute or chronic low back pain.~     The objective is to determine the prevalence of sleep alterations, the association between~     quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing~     and depression.~   "
202787|NCT00908037|"~     Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized,~     placebo controlled study involving 3 age-determined cohorts (Cohort 1: between 12 and 17~     years old; Cohort 2: between 6 and 11 years old; Cohort 3: between 1 and 5 years old). Daily~     dosing with eltrombopag will begin with 5 patients in the oldest age cohort in an open label~     fashion, and a review of safety, pharmacokinetic and platelet count data will be performed~     regularly. If no safety concerns are identified after 12 weeks, 18 additional patients will~     be randomised to placebo or eltrombopag (2:1 randomisation). After 7 weeks of randomized~     treatment, all patients will receive eltrombopag in an open label fashion. The total duration~     of treatment with eltrombopag will be 24 weeks. If at the time of the aforementioned 12 week~     review of the first 5 patients no safety issues are identified, dosing will begin in the next~     lower age cohort with an initial group of 5 patients. The same procedure will be followed in~     terms of safety review and subsequent enrolment and randomisation of the additional patients.~     Initiation of the younger age cohort will take place once data from the previous has been~     evaluated. Doses will be adjusted according to platelet counts and tolerability. The study~     will include a review of the safety data by a Data Safety Monitoring Board.~   "
202788|NCT00908024|"~     The study is expected to identify a safe dose of BMS-754807 to be given in combination with a~     standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The~     study is also intended to collect first data on the effects of the combination of BMS-754807~     with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the~     head and neck for whom cetuximab-containing therapies have not been effective~   "
202789|NCT00908011|"~     This study involves comparing the effectiveness of treatments in HIV positive patients who~     may be predisposed to heart attack or stroke. The investigators will evaluate the~     effectiveness of two drugs, often prescribed by doctors to these patients, at lowering~     cholesterol and thereby making the patient less them less vulnerable to suffering a heart~     attack or stroke. The investigators believe that the addition of a second drug, from a~     different class of cholesterol lowering medications, will improve the outcome of the patients~     by lowering cholesterol.~   "
202790|NCT00907998|"~     The design of this study will enable an extensive evaluation of safety, tolerability, and~     PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease~   "
202791|NCT00907985|"~     The purpose of this study is to investigate the effect of drug A on its own and when it is~     given in combination with drug B on markers of brain activity. The study will~        1. Assess the effects of drug A and drug B on muscle movement after brain stimulation;~        2. Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A~          and drug B when given in combination;~        3. Examine the safety of drug A and drug B when given together.~   "
202792|NCT00907972|"~     Health care burdens from neurodegenerative diseases are expected to increase~     disproportionately. Increasing age also predisposes this same population to other chronic~     diseases including osteoporosis, a progressive systemic skeletal disease characterized by low~     bone mass, which leads to an increase susceptibility to fractures. In the United States, 44~     million people are estimated to be at risk for osteoporosis and low bone mass emphasizing the~     enormity of this public health problem.~      Parkinson's disease is a progressive neurodegenerative disorder affecting about 1 million~     people. Evidence indicates that Parkinson's disease patients are at a higher risk for low~     bone mineral density, which can contribute to increased fractures compared to healthy~     subjects. In fact, several risk factors of osteoporosis in patients with PD have been~     identified, including advanced stages of PD, low body mass index, inadequate sunlight~     exposure and decreased vitamin D levels. Some or all of these factors in conjunction with~     decreased immobilization that may occur with PD, put patients at increased risks for~     fractures. Few studies however have examined bone markers in PD patients. Even fewer studies~     have examined the impact of Vitamin D supplementation on bone metabolism and mineralization~     in PD patients.~      Vitamin D is an essential component in bone health, promoting calcium absorption in the gut~     and maintaining adequate serum calcium and phosphate concentrations, which enable normal~     mineralization of bone.~   "
202793|NCT00907959|"~     The investigators' proposed phase 2 clinical trial will be an open-label, non-randomized~     study among 80 women with metastatic breast cancer. The study treatment period will be up to~     twelve months and enrollment will be open at 10-15 clinical sites in the United States. In~     this Phase 2 trial, 40 participants with hormone receptor positive tumors and 40 with hormone~     receptor negative tumors will be enrolled and treated with BZL101 20 grams/day (10 grams~     BID). Hormone receptor positive will be defined as estrogen receptor (ER)+ and progesterone~     receptor (PR)+, ER+ and PR-, or ER- and PR+. Hormone receptor negative will be defined as ER-~     and PR-.~   "
202794|NCT00907946|"~     The investigators are trying to determine whether placement of a nephrostomy tube prior to~     definitive stone surgery and under ultrasonic or fluoroscopic guidance will reduce~     complications related to bleeding and infection compare to obtaining renal access at the time~     of surgery.~   "
202795|NCT00907933|"~     This is a First Time in Human (FTIH) study to investigate the safety, tolerability and~     pharmacokinetics (PK) of a) single, escalating and b) twice-daily 14 days repeat doses of~     intranasal SB-705498 in healthy volunteers (HVT). The safety and tolerability of single~     intranasal 498 dosing will be assessed and established before initiating the evaluation of~     repeat intranasal 498 dosing.~   "
202796|NCT00907920|"~     This research study is looking at tumor samples from young patients with neuroblastoma.~     Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to cancer~   "
202797|NCT00907907|"~     The objective of this study was to evaluate the comparative bioavailability between~     Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg tablets (reference), after a~     single-dose in healthy subjects under fasting conditions.~   "
202798|NCT00907894|"~     This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety~     of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.~   "
202799|NCT00907881|"~     This study will assess the correlation between glycemic control and the hypoglycemia symptom~     score in patients with Type 2 diabetes, 12 weeks after addition of a sulfonylurea to an~     ongoing regime of oral hypoglycemic agents.~   "
202800|NCT00907868|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known~     whether whole-breast radiation therapy is more effective when given with or without~     additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ.~      PURPOSE: This randomized phase III trial is studying breast-conserving surgery followed by~     whole-breast radiation therapy to see how well it works when given with or without additional~     radiation therapy to the tumor in treating women with ductal carcinoma in situ.~   "
202801|NCT00907855|"~     Cardiac stress testing with functional nuclear imaging is an invaluable technique in the~     diagnostic and prognostic evaluation of patients with known or suspected ischemic heart~     disease. Selection of the appropriate type of nuclear stress test: exercise stress Myocardial~     Perfusion Imaging (MPI) versus pharmacologic stress MPI is crucial for not only diagnostic~     accuracy and prognostic evaluation, but also for sound clinical decisions and resource~     utilization.~      The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported~     physical work capacity to estimate peak metabolic equivalents (METs) and has been shown to be~     a valid measurement of functional capacity. The investigators hypothesized that the DASI may~     be the screening tool that evaluates functional capacity and guides selection of the optimal~     stress MPI study.~   "
202802|NCT00907842|"~     Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and~     the associated morbidity significant, standard placement of a prophylactic mesh upon stoma~     creation might prevent parastomal (or incisional herniation, after closure) and improve the~     quality of life of a large group of patients. This study is meant to be a pilot study to see~     whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh~     is placed intraperitoneally.~   "
202803|NCT00907829|"~     The purpose of this study is to determine whether neural block and neuromuscular electrical~     stimulation are effective in treating finger impairment due to stroke.~   "
202804|NCT00907816|"~     Display of information regarding utilization and quality to primary care physicians as they~     use our computer based system to order radiologic imaging (CT, MR, etc) will reduce~     unnecessary imaging.~   "
202805|NCT00907803|"~     The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two~     clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral~     dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose~     will be used in expanded pivotal safety trials.~   "
202806|NCT00907790|"~     The aim of this study is test the efficacy of a comprehensive self-management therapy to~     decrease abdominal pain/discomfort and improve quality of life in patients with irritable~     bowel syndrome (IBS) compared to IBS patients receiving their usual care.~   "
202807|NCT00907777|"~     The aim of this study is to assess the immune response, safety and reactogenicity following~     administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4~     years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or~     Prevenar™ vaccine within the first 6 months of life and a booster dose of plain~     polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.~      Antibody persistence will also be assessed at approximately 4 years of age in children~     previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a~     booster dose of Pneumovax 23™.~      This protocol posting deals with objectives & outcome measures of the extension phase at year~     4. The objectives & outcome measures of the primary phase are presented in a separate~     protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are~     presented in a separate protocol posting (NCT 00333450).~   "
202808|NCT00907764|"~     Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion~     imaging. This study will test whether regadenoson is an appropriate stress agent for stress~     echocardiography.~   "
202809|NCT00907751|"~     Multicentric non-randomized phase II opened prospective study (10 centres involved).~      Primary endpoint:~        -  To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in~          patients treated with rituximab in association with plasma exchanges.~      Secondary endpoints:~        -  To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma~          exchange sessions required to achieve a durable complete remission, and to determinate~          the duration of B-cell depletion.~        -  To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following~          treatment with rituximab, as well as the incidence of relapses.~   "
202810|NCT00907738|"~     This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683)~     dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001,~     MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving~     this drug.~   "
202811|NCT00907725|"~     The purpose of this study is to evaluate if BhCG testing to determine the completion of~     medical abortion simplifies the medical abortion protocol. Investigators hypothesize that~     women randomized to ultrasonographic determination of completion of medical abortion will~     have MORE follow-up visits/interventions beyond standard protocol than those randomized to~     medical abortion follow-up with serum BhCG.~      The investigators also hope to explore satisfaction with BhCG based follow-up among women~     seeking medical abortion. Investigators hypothesize that the majority of women who choose to~     follow-up with serum BhCG will be satisfied with this method of medical abortion follow-up.~   "
202812|NCT00907712|"~     Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study~     is to evaluate the hemodynamic changes after amputation and its relation to outcome.~   "
202813|NCT00907699|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and RNA and identify biomarkers~     related to cancer.~      PURPOSE: This laboratory study is looking at biomarkers in tumor tissue and blood samples~     from patients with non-small cell lung cancer.~   "
202871|NCT00906906|"~     The purpose of this study is to characterize blood flow in the plastic tubing of a heart-lung~     bypass machine during heart surgery. Technical specifications provided by the manufacturer do~     not consider varying hemodynamic conditions such as temperature and hemoglobin levels which~     affect blood viscosity and ultimately blood flow to and from the patient during heart-lung~     bypass.~      The investigator wishes to perform a prospective study of the heart-lung bypass tubing in~     children that require heart-lung bypass during heart surgery.~   "
202814|NCT00907686|"~     The spread of viruses through transfusions is the cause of serious illness and death in~     recipients whose immune systems are unable to fight infection. Another group of patients~     whose immune systems are underdeveloped and can be affected by a particular virus known as~     cytomegalovirus (CMV) is low birthweight infants (LBWIs). CMV can be spread through the~     placenta, during the birth process, through breast milk, while in the hospital or while~     caring for someone carrying the virus as well as through a transfusion, known as~     transfusion-transmitted (TT-CMV).~      The spread of TT-CMV in LBWIs can be curtailed by transfusing blood products that are CMV~     negative as well as to filter the white cells in blood that carry the virus (leukoreduction).~     The purpose of this study is to see if the use of these two strategies can lower the spread~     of CMV through a transfusion. How safe the blood actually is through leukoreduction is not~     known and CMV still occurs in LBWIs. It is not clear whether this approach is optimal or~     whether additional safety steps are needed to completely prevent TT-CMV. Specific actions~     that could tell us when virus has reached the blood product or breast milk is to test each of~     these to determine if virus slipped unnoticed and/or when the product was not thoroughly~     filtered.~      In this study, the investigators believe that the use of both prevention strategies will~     result in a lower rate of TT-CMV, and that the cause of TT-CMV may be found in the presence~     of CMV at the DNA level or by unfiltered white cells that remain in the blood product. Thus,~     the most significant clinical question that remains to be addressed is whether this double~     strategy for transfusion safety actually provides a zero CMV-risk blood supply or whether~     further safety measures (DNA testing + 100% leukoreduction) must be used to protect this~     extremely vulnerable patient group from CMV infection. This birth cohort study will be done~     with 6 participating NICUs, and will study both CMV positive and negative mothers in order to~     estimate the rate and pathway of CMV transmission to the LBWI who receives a transfusion.~     Another study goal is to compare or link any CMV infection by either transfused units where~     the virus was undetected, or filter failure. If CMV disease occurs, the investigators will be~     able to describe the course and outcome in LBWIs who develop TT-CMV.~   "
202815|NCT00907673|"~     A 28-week, feasibility study to investigate the safety and efficiency of the Automatic Fluid~     Shunt in patients with chronic congestive heart failure, ascites and diuretic resistance.~   "
202816|NCT00907660|"~     We hypothesize that individuals provided with 1 meal per day of portion-controlled foods~     (shakes and prepared entrees) will lose as much weight as individuals provided with 2 meals~     per day of portion-controlled foods. The study is designed to assess whether equal weight~     loss can be achieved at a lower cost to the health care system (or health care payer), with~     patients contributing some of the cost of their own treatment.~   "
202817|NCT00907634|"~     The purpose of this study is to find out how the cervix normally moves during radiation~     treatment. This study will also evaluate how cervical cancer shrinks during chemotherapy and~     radiation. By better understanding these two things, the investigators can see if radiation~     could safely be given in a more focused way in the future.~      The investigational portion of this study includes (1) daily cone beam CT scans to confirm~     transponder placement and evaluate tumor changes during treatment and (2) tracking movement~     of the cervix during daily radiation treatment.~   "
202818|NCT00907621|"~     Standardized acupuncture treatment for infant colic is a common treatment in general practice~     for doctors educated in medical acupuncture.~      The investigators plan to study whether the perceived opinion on positive results can be~     verified in a multi-center clinical trial. The investigators aim to measure the effect of~     standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized~     singe blinded prospective multi-center study, starting September 2009. The study will be done~     in thirteen locations in Norway by specialists in General Practice trained in acupuncture.~      The investigators intend to include a total of 130 patients, 65 in the intervention group and~     65 in the control group.~   "
202819|NCT00907608|"~     The purpose of this study is to examine the effect of partial correction of anemia with~     Darbepoetin alfa to a target of 11 g.dL (female) or 12 g/dL (male) on the reduction of~     cardiovascular morbidity and total mortality.~   "
202820|NCT00907595|"~     The proposed study is a double-blind, placebo controlled pilot study of HD, PD, and DLB~     subjects with sleep disturbances. This study is designed to determine the effects of 4 weeks~     Ramelteon treatment on the sleep patterns of people with basal ganglia disorders such as HD,~     PD and DLB. The study also aims to look at the sleep patterns of caregivers of people with~     HD, PD and DLB.~   "
202821|NCT00907582|"~     For relapsed acute promyelocytic leukemia after all-trans retinoic acid (ATRA) and arsenic~     treatment, remission can be achieved by chemotherapy with ATRA and/or arsenic and addition of~     mylotarg. Autologous hematopoietic cell transplantation using a polymerase chain reaction~     (PCR) negative graft is important treatment option to obtain sustainable remission. This~     study is to test the efficacy and the safety of conditioning regimen with idarubicin and~     busulfan for relapsed Acute Promyelocytic Leukemia (APL).~   "
202822|NCT00907569|"~     It is accepted that giving higher doses of chest radiation in as short a time span as~     possible improves chances of cure. In this study, the investigators propose to give an~     increased dose of chest radiotherapy for limited stage small cell lung cancer patients using~     a strategy of giving a slightly higher daily dose of radiotherapy than normal. The~     investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year~     overall survival rates in patients with limited stage small cell lung cancer.~   "
202823|NCT00907543|"~     The purpose of this study is to compare the results of preoperative chemotherapy and~     radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation~     for esophageal cancer.~   "
202824|NCT00907530|"~     This study is being conducted as a phase IV, double-blind, multi-center, randomized,~     crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of~     0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI)~     and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.~   "
202825|NCT00907517|"~     This study of SCH 900776 (MK-8776) will evaluate its safety and tolerability when given in~     combination with cytarabine to participants with acute leukemias. Participants in the~     Dose-Escalation Part will be enrolled in cohorts that will receive sequentially higher doses~     of MK-8776 in combination with standard doses of cytarabine. Only one combination treatment~     cycle of approximately 4 to 6 weeks is anticipated, but participants may receive additional~     cycles if clinically indicated after discussion between the Investigator and the Sponsor. The~     recommended combination doses for a Phase 2 trial (RP2D) will be determined based on safety~     and biological activity. Up to 10 to 15 additional participants will be studied at the~     combination RP2D.~   "
202826|NCT00907504|"~     Gemcitabine and cisplatin given together is a standard treatment option for advanced lung~     cancer patients. The purpose of this study is to assess if the life span is longer in~     patients taking the investigational drug CP-751,871 in combination with gemcitabine and~     cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs,~     1,210 participants will be required in order to have an adequate sample size (1,100 evaluable~     patients) and power to detect a 30% prolongation of survival on the experimental arm.~   "
202827|NCT00907491|"~     Cough is part of the defense mechanism to protect the lung from foreign particles and remove~     secretions from the airways. However, at times it becomes a bothersome, annoying symptom that~     interferes with the quality of life, sleep pattern and exercise tolerance of the patient.~      People with respiratory infection, asthmatic patients and CF patients suffer from a multitude~     of pathologies of airways and are often inflicted with chronic cough.~      Treatment of cough in these patients consists of many types of expectorants, cough~     suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical~     therapy (PT) is often prescribed as part of the treatment regime.~      The primary objective of the study is to evaluate the efficacy and validity of novel cough~     counting device based on the WIM Technology.~   "
202828|NCT00907478|"~     The purpose of this study is to evaluate changes in bone marrow morphology (structure) after~     long-term exposure to romiplostim.~   "
202829|NCT00907465|"~     The study is designed to develop methods for objectively measuring sedentary behavior, assess~     the association between objectively measured sedentary behavior and cardiovascular disease~     outcomes, and develop an intervention to reduce sedentary behavior, in African American~     adults.~   "
202830|NCT00907452|"~     This protocol (in patients aged 65 and over suffering from previously untreated multiple~     myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the~     number of patients analyzed and the implemented molecular diagnostics resources. The goal is~     to be able to identify patients who will best respond to the study treatments or experience~     the fewest associated side effects and improve prognosis, in order to optimize care~     management in multiple myeloma.~      To this end, the study seeks to predict the following parameters in these patients:~        -  The treatment response and occurrence of adverse events linked to a~          lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide~          combination.~        -  Progression-free survival and overall survival.~      Prediction of the treatment response and the occurrence of adverse effects will be based on:~        -  An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and~          DNA copy number variations.~        -  An analysis of changes in the tumor's genotype (change in the DNA copy number) and~          phenotype (altered gene and micro-RNA expression).~      Prediction of progression-free survival and overall survival will be based on an analysis of~     changes in the tumor's genotype and phenotype.~   "
202831|NCT00907439|"~     The purpose of this study is to determine the effect of inhaled anesthetic drugs upon~     diastolic heart function (heart suction and filling performance) in patients who are~     undergoing coronary bypass surgery.~   "
202832|NCT00907426|"~     This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution~     application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis~     of the eyelashes (inadequate or not enough eyelashes). There will be two different types of~     subjects participating in the study 1)those with inadequate eyelashes due to natural causes~     or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment.~     There will be two treatment periods of six months each. Subjects will receive either the~     study medication or vehicle in either of the two treatment periods.~   "
202833|NCT00907413|"~     This research study is a phase III double arm, multicenter, randomized controlled clinical~     trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus~     photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with~     unresectable cholangiocarcinoma.~      The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in~     increasing the survival time of patients with unresectable cholangiocarcinoma and to assess~     the effect of PDT on both cholestasis and health-related quality of life (HRQoL).~   "
202834|NCT00907400|"~     The purpose of the study is to investigate the uptake in the body of naproxen; one of the two~     active substances in PN400. We also want to show that the body's uptake of naproxen given as~     PN400 is comparable to that of currently marketed naproxen tablets.~   "
202835|NCT00907387|"~     The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate~     to severe lateral canthal lines in adults and duration of effect.~   "
202836|NCT00907374|"~     The objective of the study is to assess the effect of standard versus aggressive inhibition~     of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA)~     on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR),~     c)endothelial dysfunction (measured by post-hyperemia arterial tonometry) and d)the slowing~     of the progression of atherosclerotic disease (measured by carotid intima media thickness~     [CIMT]).~   "
202837|NCT00907361|"~     This study will create a registry of patients with pacemakers and implantable ICDs who will~     undergo clinically indicated MRI and will document the incidence of any adverse events or~     changes in device parameters that might be associated with the procedure.~   "
202838|NCT00907348|"~     This is a prospective multicenter phase II pilot trial designed with the purpose of dose~     finding to evaluate the efficacy and safety of treatment with Lenalidomide plus R-CHOP21~     (LR-CHOP21) for elderly patients with untreated Diffuse Large B Cell Lymphoma (DLBCL).~   "
202839|NCT00907335|"~     A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9~     to 11 is safe and efficacious.~   "
202840|NCT00907322|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     Dimebon following single ascending doses. A formal single ascending dose study of this nature~     has not been performed to date in the Dimebon development program.~   "
202841|NCT00907309|"~     The purpose of the project is to improve adolescent behavioral counseling services in~     healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy~     (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.~   "
202842|NCT00907296|"~     This is an international, multi-center, randomized, double blind, placebo controlled study of~     AMG 785 in skeletally mature adults with a fresh unilateral tibial diaphyseal fracture status~     post a definitive fracture fixation with an intramedullary (IM) nail. The primary hypothesis~     for this study is that AMG 785 compared with placebo is effective in reducing radiographic~     healing time of fresh tibial diaphyseal fractures.~   "
202927|NCT00906139|"~     The purpose of this study is to compare propofol associated with fentanyl versus midazolam~     plus fentanyl for sedation during diagnosis or therapeutic upper gastrointestinal endoscopy~     (UGE) in cirrhotic patients.~   "
202843|NCT00907283|"~     This trial is a multicenter, unblinded, single-arm pilot study, lasting one year (plus one~     year extension Amendment n.3 25 August 2009, plus two years follow-up Amendment n.7) , to~     evaluate the efficacy and safety of the chelator therapy with deferiprone on cerebral iron~     accumulations. The drug will be administered in the dosage of 15 mg/kg twice daily. The~     safety and tolerability of the drug will be evaluated by measuring hemochrome every seven~     days with leukocyte formula count.~      At 3, 6 and 12 months from the start of treatment, a neurological evaluation will be~     performed using several specific evaluation scales (International Cooperative Ataxia Rating~     Scale (ICARS); Unified Parkinson's Disease Rating Scale (UPDRS); Burke-Fahn-Marsden (BFM)).~      Every 6 months of treatment, a brain magnetic resonance image (MRI) aimed at measuring iron~     overload quantitatively, if possible.~   "
202844|NCT00907270|"~     Participants will be randomly assigned in one of two groups. Group A: oral supplementation~     with 4,000 IU of vitamin D (cholecalciferol). Group B: oral supplementation with 400 IU of~     vitamin D (cholecalciferol). Both treatments will be consumed daily for 6 months.~      Outcomes will be evaluated at baseline, three and six months. Variables related to leptin~     resistance will be evaluated.~      The main hypothesis is that vitamin D will diminish leptin resistance in overweight and obese~     women. If the hypothesis is confirmed, women will show a reduction in the Resting energy~     expenditure: serum Leptin ratio (REE: Leptin ratio), as well as a reduction of hunger, body~     weight, body and abdominal fat and an increase in resting energy expenditure.~   "
202845|NCT00907257|"~     A study to determine if using 2 acne products in the morning is as safe and efficacious as~     using one product in the morning and one product in the evening.~   "
202846|NCT00907244|"~     The purpose of this study is to get information regarding the usefulness and accuracy of this~     new magnetic resonance imaging (MRI) technique - termed arterial spin labeling (ASL) - in the~     diagnosis of pediatric brain tumors.~   "
202847|NCT00907231|"~     This is a multi-center study to assess the diagnostic accuracy of the Troponin I assay in the~     Biosite Triage Cardio3 Panel at the point-of-care (POC) in adults presenting to the emergency~     department with possible acute myocardial infarction (AMI).~   "
202848|NCT00907218|"~     The purpose of this research study is to learn about the efficacy of a medication called~     varenicline (Chantix) in treating ADHD in adults and in reducing cigarette smoking in adults~     with ADHD. The investigators hypothesize that ADHD symptomatology in adults with ADHD will be~     improved with varenicline treatment. The investigators also hypothesize that varenicline~     treatment will result in significant reductions in cigarette smoking. Another objective of~     this study is to more fully evaluate the response and tolerability to varenicline in this~     group of cigarette smoking adults with ADHD.~   "
202849|NCT00907205|"~     The purpose of this study is to evaluate the safety and tolerability of SF1126 in patients~     with advanced or metastatic tumors by assessing the dose limiting toxicities (DLTs) and~     defining the maximum tolerated dose given twice per week for 4 weeks and ultimately define a~     recommended phase II dose.~   "
202850|NCT00907192|"~     Primary Objective:~        1. To determine the frequency of self-reported over and under use of opioid analgesics in~          patients with advanced cancer. Patients with advanced cancer are those patients who have~          been described to have either one of the following: recurrent disease, those that have~          failed multiple chemotherapies (more than second line therapy), locally advanced~          disease, and metastatic disease.~      Secondary Objectives:~        1. To determine the association between patients' knowledge, attitudes and beliefs about~          opioids, and frequency of deviation in opioid use with patients' demographic~          information.~        2. To determine association between alcohol abuse/chemical coping and self-reported~          deviations in opioid use.~        3. To determine the association between the use of opioids and patient-related barriers to~          opioid use.~   "
202851|NCT00907179|"~     LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by~     blocking certain enzymes. LBH589 has shown effects against cancer in laboratory studies and~     in studies using animals; however, it is not known if this medicine will show the same~     activity in humans. As of May 2006, approximately 100 patients have received treatment with~     either an intravenous or capsule form of LBH589. Only the capsule form of LBH589 will be used~     in this study. In addition, information from other research studies and laboratory studies~     suggests that this study drug may help to treat lung cancer.~      The main goal during the Phase I portion of this research study is to find out the highest~     and safest dose of LBH589 that can be given in combination with pemetrexed in subjects with~     lung cancer without causing severe side effects. The main goal of the Phase II portion of~     this study is to find how the patient's lung cancer responds to the LBH589 in combination~     with pemetrexed.~      This study will also investigate how the patient's body processes the combination of LBH589~     and pemetrexed. To determine this, the investigators will measure the amount of study drug in~     the patient's blood. This will be done with a series of blood tests, called pharmacokinetic~     (PK) tests. Other purposes of this study will be to determine the side effects of LBH589 in~     combination with pemetrexed and whether or not this combination is effective in treating your~     type of cancer.~   "
202852|NCT00907166|"~     The objectives of this study are:~        -  To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine,~          in cancer patients.~        -  To compare the safety and efficacy of CPI-613/Gemcitabine combination vs. Gemcitabine~          alone in patients with carcinoma of the pancreas.~   "
202853|NCT00907153|"~     The purpose of this study is to determine if vitamin D will improve insulin resistance,~     inflammation, and overall well-being in women with PCOS.~   "
202854|NCT00907140|"~     Rationale: Diagnostic procedures, such as positron emission tomography (PET) using~     fluorodeoxyglucose (FDG), may help determine response to standard cancer therapy in patients~     with cervical cancer~      The purpose of this study is to evaluate the change in cervical tumor heterogenity as~     measured by FDG-PET/CT imaging.~   "
202855|NCT00907127|"~     The study will test whether damage of the heart nerves appears in patients before they~     develop diabetes.~   "
202856|NCT00907114|"~     The purpose of this study is to determine the efficacy and safety of topic ketorolac in~     treatment for center point thickness secondary to panphotocoagulation in proliferative~     diabetic retinopathy.~   "
202857|NCT00907101|"~     The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing~     antibiotic sensitive and resistant strains of P acnes in vivo.~   "
202860|NCT00907062|"~     Vitiligo is a common hypopigmentation disorder with significant psychological impact if~     occurring before adulthood. One study investigating the use of Ginkgo biloba for the~     treatment of vitiligo in adults reports effectiveness, but has significant flaws. We endeavor~     to conduct an open label pilot clinical trial replicating the previous trial on 12~     adolescents 12 to 18 years old. The purpose of the pilot is to test the feasibility of~     recruitment and patient retention, variability of outcome measures, and identify major safety~     concerns. The pilot will use 60 mg of standardized G. biloba two times per day (BID) for 12~     weeks. The primary outcome will be the validated Vitiligo European Task Force (VETF)~     evaluation form, secondary outcomes will include the Vitiligo Area Scoring Index (VASI),~     assess repigmentation via photographs, and will monitor and report adverse reactions.~   "
202861|NCT00907049|"~     A prospective study to assess the association between the change in quality of sleep and the~     change in intensity of pain in Spanish patients seen for subacute or chronic neck pain. The~     objective is to determine the prevalence of sleep alterations, the association between~     quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing~     and depression.~   "
202862|NCT00907036|"~     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of~     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either~     kill them or deliver cancer-killing substances to them without harming normal cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving cyclosporine before and after the transplant may stop this from happening. Once the~     donated stem cells begin working, the patient's immune system may see the remaining cancer~     cells as not belonging in the patient's body and destroy them (called graft-versus-tumor~     effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may~     boost this effect.~      PURPOSE: This phase II trial is studying the side effects of fludarabine phosphate,~     melphalan, and alemtuzumab followed by donor stem cell transplant in treating patients with~     relapsed Hodgkin lymphoma.~   "
202863|NCT00907023|"~     The aim of this study is to determine the influences of discharge teaching and care~     coordination on how ready a parent is to take their child home from the hospital after a~     solid organ (kidney, heart and liver) transplant. This study will also look into how the~     parent handles coping, utilization of healthcare resources, and parent adjustment 3 weeks~     after discharge from the hospital.~   "
202864|NCT00907010|"~     Objective: Evaluate the muscular strength in the ageing process and identify the changes~     between the abdominal muscles, upper and louver edges.~      Method: 48 individuals participated in this study, being divided into four groups according~     to the age: (G1) 11to 18 years old, (G2) 20 to 26 years old, (G3) 45 to 60 years old and (G4)~     66 - 82 years old. The excluding criterion included people who work out more than three times~     a week, severe arthrosin, stroke, significant cognitive deficit , obesity, use of ortheses~     for louver members or any break, with or without metallic implant. The evaluation instruments~     used were: (1) Esfigmomanômetro (EM), (2) Trunk flexor in the supine position,, (3) Jamar~     Dinamômetro and (4) Preston Pinch Gauge Dinamômetro.~   "
202865|NCT00906997|"~     Aims:~        1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT)~          versus colonoscopy every 10 years for the reduction of colorectal cancer-related~          mortality at 10 years in average-risk population.~        2. To determine the compliance and complications associated with both strategies.~      Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias,~     Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).~      Study groups:~        -  Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive~          result.~        -  Group II: colonoscopy.~      Sample-size calculation: 27,749 subjects in each study group (total: 55,498).~   "
202866|NCT00906984|"~     The purpose of this protocol is to provide TheraSphere treatment for patients with liver~     cancer who cannot be treated by surgery. The effect on the tumor and any side effects of~     TheraSphere treatment will be examined. This study will provide supervised and limited access~     to TheraSphere treatment at University California Irvine Medical Center.~      TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has~     been used previously in the treatment of liver tumors. When Y-90 is incorporated into very~     tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels~     supplying the liver. This allows a large dose of radiation to be delivered to the tumor with~     less risk of toxic effects from radiation to other parts of the body or to healthy liver~     tissue. The radiation from TheraSphere is contained within the body and becomes minimally~     active within 7 days after treatment due to physical decay. The glass beads remain in the~     body, but do not cause any health problems. TheraSphere has been approved for use in the~     treatment of liver cancer in the United States by the Food and Drug Administration on a~     limited basis.~   "
202867|NCT00906971|"~     The purpose of this study is to determine whether physiotherapy is effective in the treatment~     of the chronic functional constipation in children.~   "
202868|NCT00906945|"~     This study is designed to test the combination of Plerixafor with G-CSF for~     chemosensitization in patients with relapsed or refractory AML.~   "
202869|NCT00906932|"~     This is a two part study comparing the Trachview videoscope to standard laryngoscopy in their~     ability to visualize the glottic opening. It is hypothesized that the glottic view is~     improved with the Trachview videoscope. Not only can the Trachview provide an alternative and~     often improved view of the airway, but can be used for teaching novice intubators.~     Furthermore, the Trachview requires minimal deviation from standard intubating techniques and~     thus, it is much easier to learn and use than many fiberoptic scopes currently available.~   "
202870|NCT00906919|"~     The goal of this randomized controlled trial is to determine if greater effectiveness can be~     achieved by the addition of lay-led self-management patient education to regular~     professionally-led diabetes patient education in comparison to regular professionally-led~     diabetes patient education only.~   "
202928|NCT00906126|"~     A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment~     labor in nulliparous women diagnosed with arrest of dilation.~   "
202872|NCT00906893|"~     Hypoxia is recognized to be an independent predictor of clinical outcome in oncology. PET~     using [18F]-FMISO has been described to be useful for the non invasive assessment of hypoxia~     in cancer. The use of this radiotracer for brain tumours is very limited and there is no~     standard to acquire and quantify [18F]-FMISO uptake. So there is a need for a methodological~     evaluation of this PET tracer The purpose of this research is to define optimal parameters~     for acquisition and data exploitation to quantify [18F]-FMISO uptake and so predict clinical~     outcome in glioblastomas.~      Low sensitivity to radiation of glioblastoma is partly caused by hypoxia. Hypoxia in tumours~     is not predicted by tumour size. Detecting and monitoring tissue oxygenation are of great~     interest to modify therapeutic strategies, including local dose escalation for radiotherapy~     or select chemotherapeutic agents with better impact in glioblastomas.~      PET with appropriate radiotracers, especially [18F]-FMISO, enables non-invasive assessment of~     hypoxia. [18F]-FMISO only accumulates in viable hypoxic cells. So, it has been demonstrated~     that PET using 18F-FMISO is suitable to localize and quantify hypoxia. But there isn't any~     optimal acquisition protocol or standardized images quantification treatment. Thus, the~     interpretation of [18F]-FMISO PET images and the predictive value of [18F]-FMISO SUV~     (Standardized Uptake Value) remain unclear explaining the need of methodological approaches.~   "
202873|NCT00906880|"~     Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination~     of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human~     African trypanosomiasis (HAT) in the meningo-encephalitic phase.~      Overall objectives:~      Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to~     treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the~     meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the~     National HAT Control Programme, NGO treatment centers).~      Primary objective:~        -  Assess the clinical response of the NECT co-administration under field conditions.~      Secondary objectives:~        -  Assess the incidence and type of adverse events (AE), and the capacity of the treatment~          centers to deal with these.~        -  Assess the feasibility of the implementation of the NECT coadministration by the health~          center.~        -  Assess the effectiveness of the NECT co-administration at 24* months after treatment.~   "
202874|NCT00906867|"~     Vocal cord dysfunction is a rare clinical picture. It is labeled as a sudden and threatening~     dyspnea. Patients with VCD may also present cough, hoarseness, wheezing, and chest tightness,~     but an inspiratory stridor is the most common symptom. For this reason, such patients are~     often misdiagnosed with refractory asthma, because of poor response to steroids and~     bronchodilators. Diagnosis is suspected on clinical grounds and is confirmed with~     laryngoscopy. The therapy consists of education, speech therapy and if necessary~     psychotherapy. The purpose of the investigators' study is to characterize children,~     adolescents, and young adults with VCD, and the evaluation of predictors as atopy, bronchial~     hyperresponsiveness, and psychiatric features.~   "
202875|NCT00906854|"~     Introduction: Urinary incontinence is often seen as a problem that affects multipara and~     old-aged women, however, there is evidence that during high impact physical activity, mainly,~     or those ones which promote a sudden increase of intra-abdominal pressure, this symptom is~     common, even among young women, physically active, and without known risk factors.~      Objective: Evaluate the prevalence of urinary incontinence in nulliparous and nulligest women~     who regularly practice physical activities.~      Method: 108 women, nulliparous and nulligest, average age 23.9 years old (from 18 to 30 years~     old) who exercise regularly. They were divided into 3 groups according to the regular~     practice of exercise forms, they are (G1) weight training, (G2) aerobic exercises, included~     jump, step and dancing classes, and (G3) swimming (crawl mode). All participants were~     questioned about the perception of leakage of urine during the practice of exercises. The~     established exclusion criterion included: surgeries of urinary tract, urinary infections,~     gestations, child-birth, advanced aged, obesity, sedentariness and practice of only one form~     of physical activity.~   "
202876|NCT00906841|"~     Phase II, multi-centric, open-label, study.~      Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of~     fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first~     line of chemotherapy.~   "
202877|NCT00906828|"~     The purpose of this study is to determine whether oral intake of COMT inhibitors affects the~     smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced~     Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma~     concentrations of levodopa more fluctuating.~   "
202878|NCT00906802|"~     One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric~     emptying (DGE), otherwise known as gastroparesis, which is not fatal but results in~     prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as~     nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular~     diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.~   "
202879|NCT00906789|"~     This is a clinical trial using retrospective data of two different software devices developed~     by Riverain Medical Group: Softview and OnGuard 5.0. The two studies will be run~     concurrently. Riverain Medical Group's computer systems are designed to assist radiologists~     in their identification of lung cancer on chest radiographs. The current machine received FDA~     Pre-Market Approval. This is to test two new software approaches.~   "
202880|NCT00906776|"~     Randomised, controlled, clinical study to compare the effect of the combination of bone~     ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the~     treatment of deep-wide intrabony defects~   "
202908|NCT00906399|"~     The primary objective of this study is to determine the efficacy of peginterferon beta-1a in~     reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis~     (RMS) at 1 year. The secondary objectives of this study are to determine whether~     peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the~     total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance~     imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the~     progression of disability.~   "
202963|NCT00905645|"~     Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary~     augmentation, primary reconstruction, and/or revision of the female breast.~   "
202881|NCT00906763|"~     Chocolate consumption has long been associated with enjoyment and pleasure. Popular claims~     confer on chocolate the properties of being a stimulant, relaxant, euphoriant and~     antidepressant. These possible pharmacological actions might be related to various biogenic~     amines, such as serotonin, dopamine, tyramine, histamine, phenylethylamine and~     cannabinoid-like substances. Most amines are metabolized by monoamineoxidase-A (MAO-A) and~     are therefore unable to pass the blood-brain-barrier. In contrast, phenylethylamine is a~     direct dopamine releasing ingredient and as a substrate of MAO-B and due to its lipophilic~     structure even capable to pass the blood-brain-barrier. Within this line, own clinical~     observations suggested an increased chocolate consumption in patients with Parkinson's~     disease (PD) compared to healthy subjects and to their pre-disease state.~      In a previous study, we assessed the consumption of chocolate and non-chocolate sweets in PD~     patients and their partners (as household controls) using a self-questionnaire. Consumption~     of chocolate was significantly higher in PD patients compared to controls, while consumption~     of non-chocolate sweets was similar in both groups. Our study suggests that chocolate~     consumption is increased in PD independent of concomitant depressive symptoms measured by~     BDI-1. Although reasons for increased chocolate consumption in PD remain elusive, it may~     hypothetically be a consequence of the high content of various biogenic amines as a content~     of cocoa influencing dopamine metabolism.~      Therefore, in the present study we aim to study the effects of dark chocolate with high cocoa~     content (85%) compared to chocolate without any cocoa (white chocolate) on motor symptoms in~     PD patients as measured with UPDRS part III (motor score). The principle design of the~     intervention is similar to the standard pharmacological challenge test for studying effects~     on motor symptoms in PD (e.g. levodopa challenge test).~   "
202882|NCT00906750|"~     Eligible research subjects will be randomized to receive either FluMist or inactivated~     influenza vaccine then stratified by age and necessity to receive either one or two~     immunizations. Subjects requiring one immunization will be immunized at Day 0. Subjects~     requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed~     for 30 minutes following vaccination and given a diary card to record symptoms after each~     vaccination.~   "
202883|NCT00906737|"~     This study is being done to test the possible benefits of task-specific focused ankle~     training using the Ankle-Bot on subjects with Multiple Sclerosis who have foot-drop. The~     study also compares the effectiveness of task-specific focused ankle training using the~     Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.~   "
202884|NCT00906724|"~     Hypothesis: Insulin-resistant African-American and Hispanic adolescents will show significant~     improvement of insulin sensitivity (SI) and positive changes associated with fibrinolytic~     markers and lipid profile after a two month supervised aerobic training.~   "
202885|NCT00906711|"~     Introduction: While growing older, it is possible to notice a decrease in the functional and~     physiological reserves in the organism which impairs the the abilities in the elderly in~     doing some tasks. A simple balance becomes a challenge.~      Objective: To evaluate the functional balance in the aging process.~      Methods: The group was formed by 48 people from 10 to 85 years old. The evaluation~     instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment~     (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.~   "
202886|NCT00906698|"~     To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of~     oral BIBW 2992 in combination with intravenous or oral vinorelbine~   "
202887|NCT00906685|"~     Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no~     treatment has been available to improve visual acuity. The present study intends to~     investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated~     control patients.~   "
202888|NCT00906672|"~     Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the~     innovative technique Integra® and the technique of reference: the flap surgery.~   "
202889|NCT00906659|"~     The purpose of this study is to correlate changes of visual function three weeks after~     photocoagulation for macular edema, with changes of center point thickness and macular~     volume.~   "
202890|NCT00906646|"~     This was a prospective randomised trial of metabolic therapy including antioxidants and~     cellular energisers to determine whether this therapy could improve the results of cardiac~     surgery. The hypothesis was that the metabolic therapy could improve clinical recovery.~   "
202891|NCT00906633|"~     This trial is an observational study about combination antifungal therapy in hematologic~     patients with proven and probable invasive fungal infections (IFI).~   "
202892|NCT00906620|"~     SEYLE is a health promoting program for adolescents in European schools. Its main objectives~     are to lead adolescents to better health through decreased risk-taking and suicidal~     behaviors, to evaluate outcomes of different preventive programs and to recommend effective~     culturally adjusted models for promoting health of adolescents in different European~     countries. Because of the significance of the SEYLE program and the importance of suicide~     research, Israel is honored to take part in this program and be a collaborator in it's~     implementation and research.~   "
202893|NCT00906607|"~     Introduction: Urinary incontinence (UI) is considered erroneously by many as being a~     phenomenon of the aging process, however there is a growing prevalence of complaints of UI in~     nulliparous and nulligest young women.~      Objective: To investigate the prevalence of urinary incontinence in women of different age~     groups.~      Method: 78 nulliparous and nulligest women of different resident age groups in the city of~     France, being these divided in: G1 (10-18 years); G2 (20-35 years); G3 (45-60 years) and G4~     (65-75 years). Excluded from this study were women with cancer or surgeries of the inferior~     urinary treatment, urinary infection, alterations cognitive, pregnant and obesity. All the~     participants were questioned as a perception of urine loss, to the efforts or effortlessly~     evident.~   "
202894|NCT00906594|"~     The purpose of this study is to evaluate the additive effect of dorzolamide/timolol fixed~     combination in patients undergoing monotherapy with latanoprost.~   "
202895|NCT00906581|"~     Use of a computer-based treatment will reduce level of depression.~   "
202909|NCT00906386|"~     The main hypotheses guiding the study are:~        1. Stable methadone maintenance patients receiving varenicline will be more likely to~          maintain abstinence than patients receiving placebo~        2. There will be no differences in the type and number of symptoms reported between stable~          methadone maintenance patients receiving varenicline and placebo~        3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers~        4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline~          between male and female participants~   "
202910|NCT00906373|"~     To determine if IMC-A12 given in combination with Sorafenib is safe and effective for~     patients with advanced liver cancer.~   "
203893|NCT00892944|"~     The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain.~     This will then help to make accurate predictions of efficacy and dosing in the future~     development programme.~   "
202896|NCT00906568|"~     Chronic bronchial inflammation is an important clinical feature in cystic fibrosis.~     Approximately 10% of patients with cystic fibrosis suffer from Allergic Bronchopulmonary~     Aspergillosis. In addition airway inflammation in patients with cystic fibrosis (CF) plays a~     major role in progression of CF lung disease. In patients with mild disease (Vital capacity~     >75%) airway inflammation is often under diagnosed.~      Severity of allergy against Aspergillus fumigatus will be examined using radioallergosorbent~     test and skin Prick-test. Subsequently, in patients with established sensitization (RAST ≥~     0.35 IU/mL) a specific bronchial provocation with Aspergillus will be performed. In addition,~     exhaled nitric oxide,carbon monoxide, exhaled air temperature and inflammatory cells in~     sputum is measured. 24 hours after bronchial allergen provocation, exhaled NO, CO, air~     temperature, and bronchial responsiveness is determined and a second sputum obtained.~      This study is designed to characterize patients with CF and sensitization against Aspergillus~     fumigatus in an early stage to prevent pulmonary complications of ABPA. In addition sputum~     cytokine profiles in CF patients with mild and moderate disease may be different in patients~     without and with involvement of small airway disease (SAD).~   "
202897|NCT00906555|"~     Adequacy of solute clearance makes a profound impact on clinical outcome in maintenance~     hemodialysis patients. Thus far, guidelines on the target of solute clearance (Kt/V or URR)~     are based on patients with three dialysis sessions per week. However, quite a few patients~     have their dialysis sessions twice per week in China. The dialysis target of solute clearance~     in this population remains to be elucidated. The aim of this study was to explore the optimum~     target solute clearance (Kt/V or URR) in maintenance hemodialysis patients with two dialysis~     sessions per week. Two groups of hemodialysis patients with different Kt/V (1.2 ≤ Kt/V ＜ 1.7~     versus Kt/V ≥ 1.7) will be followed until 96 weeks in this prospective, randomized,~     multi-center, interventional study.~   "
202898|NCT00906542|"~     Pneumonia is a frequent complication of acute stroke and is associated with increased~     mortality and long-term impairment in the affected subjects. In previous studies, a number of~     clinical (e.g., dysphagia, severe neurological impairment, mechanical ventilation),~     radiological (e.g., large infarctions in the territory of middle cerebral artery, insular~     infarction) and biochemical (e.g., increased serum levels of C-reactive protein, decreased~     levels of CD4+ T-lymphocytes) findings have been reported as risk factors of stroke-related~     chest infection. The present study (PRECAST) aims to identify a small set out of these~     previously described risk factors that can predict stroke-related pneumonia with high~     sensitivity and specificity.~   "
202899|NCT00906529|"~     The purpose of this study is to determine whether aggressive (goal pre-prandial blood glucose~     <110 mg/dl) versus conservative (goal pre-prandial blood glucose <180mg/dl) diabetes~     treatment of type 2 diabetic patients on the general medical wards has any effect on hospital~     outcomes.~   "
202900|NCT00906516|"~     Bradmer Pharmaceuticals, Inc. (Bradmer) is requesting approval to study the safety of~     Neuradiab® when combined with Bevacizumab (Avastin) therapy given at a minimum of 30 days~     after Neuradiab administration in patients with a first or second recurrence of glioblastoma~     multiforme (GBM), in an attempt to manage life threatening recurrence of Grade IV malignant~     glioma.~   "
202901|NCT00906503|"~     RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before~     and after steroid therapy may help doctors assess a patient's response to treatment and help~     plan the best treatment.~      PURPOSE: This phase I trial is studying fludeoxyglucose F 18 PET scan performed before and~     after ultra short-term dexamethasone therapy to see how well it measures changes in nodules~     in patients with lung nodules.~   "
202902|NCT00906490|"~     The primary objective of this study is to evaluate the performance and safety of the~     intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance~     when each method is compared to the Yellow Springs Instrument (YSI) under various conditions~     in the operating room (OR), ICU and general ward (GW) in subjects undergoing elective or~     non-emergent surgery as well as subjects admitted to the medical/surgical ICU. POC meter~     systems are currently used in the hospital environment to measure blood glucose values. The~     YSI is an accepted reference standard for assessing POC meter accuracy.~      The secondary objective of this study is to evaluate the performance of the IVBG System as~     compared with the YSI under various conditions in the operating room (OR), intensive care~     unit (ICU) and general ward (GW) in subjects undergoing elective or non-emergent surgery as~     well as subjects admitted to the medical/surgical ICU.~   "
202903|NCT00906477|"~     The purpose of this study is to determine whether modified CI therapy treatment is suitable~     and effective in the early rehabilitation after stroke, and to compare early CI intervention~     with a later CI intervention group.~   "
202904|NCT00906451|"~     During myocardial infarction, inflammatory response may negatively influence ventricle wall~     remodeling as well as endothelium-dependent vasomotor function in the coronary and systemic~     arterial systems. Statins have been consistently proved to attenuate inflammation and improve~     endothelial function. In this study, we tested the effect of different doses of statin on~     inflammatory response and endothelium-dependent vasodilation.~   "
202905|NCT00906438|"~     It is already known from animal studies that the study drug can improve mucosal immunity as~     shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an~     oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In~     addition, this trial will aim to determine if this intake is able ot improve serum and~     salivary IgA synthesis.~   "
202906|NCT00906425|"~     The purpose of this study is To demonstrate that there is no difference in change in bone~     level around P.004 implants between 1st stage surgery and 6 months post surgery when~     transmucosal implant placement is compared to submerged implant placement~   "
202907|NCT00906412|"~     This is part of a larger study for which participants have already completed memory and~     thinking tests. In this study, investigators are trying to learn how deep-brain stimulation~     affects memory skills in essential tremor (ET) patients. We are especially trying to figure~     out how stimulation on each side of the brain may affect working memory.~   "
202925|NCT00906165|"~     The study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone~     Level Implant SLActive placed in healed alveolar ridge (at least 8 weeks post extraction) and~     immediately provisionalised versus the same type of implants placed in healed alveolar ridge~     but not provisionalised. In both cases the implants will be loaded at 16 weeks (final~     restorations). The outcomes will be evaluated over a 2-year period.~   "
202911|NCT00906360|"~     This phase I trial is studying the side effects and best dose of sunitinib when given~     together with cetuximab and radiation therapy in treating patients with locally advanced or~     recurrent squamous cell carcinoma of the head and neck. Sunitinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow~     to the tumor. Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving sunitinib together with cetuximab and radiation therapy~     may kill more tumor cells.~   "
202912|NCT00906347|"~     This is a prospective, randomized, controlled trial designed to examine the efficacy of oral~     misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.~   "
202913|NCT00906334|"~     This study will explore the efficacy and safety of a regimen of ON 01910.Na as a 48-hour~     continuous intravenous infusion once a week for 3 weeks of a 4-week cycle in MDS patients~     with Trisomy 8 or classified as Intermediate-1, -2 or High Risk who are not responding to~     current therapeutic options. The rationale for this trial is based upon data from laboratory~     studies with ON 01910.Na and upon activity that has been observed in other clinical trials~     with ON 01910.Na in patients with MDS.~   "
202914|NCT00906321|"~     Background:~        -  Chemoprevention is the use of preventive medications to reduce the risk of breast cancer~          for women who are at a high risk of developing the disease. Although the treatment has~          shown effectiveness in preventing cancer development, chemoprevention is notably~          underutilized even by women who are at a high risk of developing breast cancer.~        -  Researchers are interested in determining if better decision support mechanisms, such as~          interactive Web sites, can help to overcome some of the barriers to chemoprevention.~      Objectives:~      - To develop and test a prototype Web-based module that will provide decision support to~     women who are considering chemoprevention for breast cancer.~      Eligibility:~        -  Women 35 years of age and older who are at high risk for breast cancer and whose doctor~          has recommended chemoprevention (either Tamoxifen or Raloxifene), and who have no other~          history of cancer (apart from non-melanoma skin cancer or precancerous cervical~          lesions).~        -  Participants must have a working e-mail address and access to a computer with internet~          access and a telephone.~      Design:~        -  Participants who are considering chemoprevention will be randomized to a Web-based~          decision support module or standard care online information resources.~        -  Participation lasts two months and involves using the online resources provided and~          filling out questionnaires two times during the study (at the beginning and the end).~      The first time will be at the begin of the study.~        -  No medical treatments are offered as a part of this study~   "
202915|NCT00906308|"~     This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency~     of moderate to severe hot flushes in postmenopausal women.~   "
202916|NCT00906295|"~     The purpose of this study is to determine whether a higher threshold for transfusion with red~     blood cells improves the postoperative ambulation.~   "
202917|NCT00906282|"~     The purpose of this multi-center Phase II trial is to examine the impact of~     pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and~     III non-squamous NSCLC. Because patients with non-squamous type NSCLC have been shown to have~     better survival rates than patients with squamous tumors when given pemetrexed with a~     platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and~     undifferentiated), not including squamous histology, will be allowed to participate in this~     study. If this novel regimen proves to be safe and active in this setting, it will provide~     rationale for further investigation in a larger, prospective, randomized trial.~   "
202918|NCT00906269|"~     The purpose of this study is to determine if adding hyperbaric oxygen therapy, a therapy that~     delivers oxygen under slight pressure, to a drug treatment of PDE5I (such as Viagra, Levitra,~     Cialis)for men following surgery for prostate cancer will result in more men being able to~     continue to have erections.~   "
202919|NCT00906256|"~     The purpose of this study is to determine the pharmacokinetic profile of oral doses of~     AZD7295 capsules in healthy subjects, and also to assess the effects of food as well as~     safety and tolerability.~   "
202920|NCT00906243|"~     This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an~     out-patient setting. The present study is one of two clinical trials of the RNActive®-derived~     vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first~     clinical trials conducted for this novel vaccine.~      The Phase I part of the study consists of a staggered inclusion of subjects in two cohorts of~     3, to confirm the safety of the intended dose (320 µg RNA per antigen), with a lower dose to~     be considered in case of dose-limiting toxicity (DLT) being reported in greater than or equal~     to 2 out of 3-6 subjects; in this way, the recommended dose (RD) for the Phase IIa part of~     the study will be established. In the Phase IIa part of the study, additional subjects will~     be included at the RD, to confirm the safety and explore the activity of that dose.~   "
202921|NCT00906217|"~     This study aims to further define the appropriate population for Pico-Salax, a purgative used~     prior to colonoscopy. Patients over the age of 70 years with normal renal function scheduled~     for colonoscopy will receive Pico-Salax and have pre and post preparation bloodwork and~     electrocardiograms (ECGs).~   "
202922|NCT00906204|"~     In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence~     was found that a single large dose of Thymoglobulin on the day of kidney transplantation~     produced better kidney function than the standard dosing plan, when the same amount is~     divided into smaller doses on 4 days. This new study repeats that dose comparison, but with~     double-blinding and at multiple transplantation centers.~   "
202923|NCT00906191|"~     The objective of this study is to investigate how quickly and to what extent the 14-Carbon~     labeled SAM-531 is absorbed into the bloodstream, converted and eliminated from the body~     after oral administration in healthy male subjects. As 14-Carbon labeled SAM-531 is~     radioactive, this enables the compound to be traced in blood, urine and feces.~   "
202924|NCT00906178|"~     The investigators propose to design and test an Internet-based HIV prevention program for~     adolescents in Uganda.~   "
203894|NCT00892931|"~     The purpose of this study is to determine the safety and effectiveness of Azixa in patients~     with recurrent glioblastoma multiforme~   "
202929|NCT00906113|"~     Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for~     retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye~     such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child~     with retinoblastoma will have active cancer in a single remaining eye with useful vision. In~     such cases, it is sometimes necessary to remove this eye. In such cases, the injection of~     chemotherapy directly into the artery that supplies the eye and the tumor may lead to~     regression of the tumor without the need to remove the eye.~      This form of treatment was pioneered by a group in New York (Abramson et al). In this study~     the investigators will assess the efficacy and safety of the technique in a group of children~     with retinoblastoma.~   "
202930|NCT00906100|"~     The purpose of this study is to determine the proportion of patients who are undergoing~     Biventricular (BiV) Implantable Cardioverter Defibrillator (ICD) implantation in whom~     optimization of atrioventricular (AV) delay is not possible due to prolonged~     inter-atrial/intra-atrial delay. These patients would benefit from left atrial pacing, and if~     a significant number of patients fall into this group, it may be beneficial to develop a left~     atrial lead.~   "
202931|NCT00906087|"~     The purpose of this study is to determine if one of the genes that can cause glaucoma, called~     myocilin, are associated with larger eye pressure and blood pressure changes in sitting and~     lying down positions without glaucoma drug treatment and with glaucoma drug treatment with a~     combination medication called Cosopt® (Merck & Co., Inc.).~   "
202932|NCT00906074|"~     This is an observational study to evaluate the relative importance of the known risk factors~     for severe surgical site infections (SSIs) on the development of the more severe SSI cases,~     and to describe the demographic, clinical features, etiology and the management and outcome~     of patients suffering from severe SSIs in Spain.~   "
202933|NCT00906061|"~     There is little information of Eastern Cooperative Oncology Group (ECOG) performance status~     (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into~     Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.~      This low rate makes the investigators think about the possibility of a bias selection, due to~     the existence of this exclusion criteria that do not permit to include patients with~     deteriorated performance status.~      In these types of patients, the toxicity is an important issue to decide the therapeutic~     strategy. Gemcitabine and Docetaxel combination is very interesting because they have a~     different toxicity profile. This combination has demonstrated activity in several types of~     tumours, as breast cancer, sarcoma and lung cancer.~      The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel;~     activity and dose intensity will be the same, but toxicity will be significantly low.~   "
202934|NCT00906048|"~     The primary objective is: to assess the microbiological success of the combination of~     levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of~     an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the~     treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the~     prosthesis.~      The secondary endpoints are:~        -  To assess the rate of clinical failure 12 months after the reimplantation of the~          prosthesis.~        -  To assess the joint mobility function score 12 months after the reimplantation of the~          prosthesis.~        -  To assess the safety of the combination of levofloxacin and rifampicin.~        -  To investigate prognostic factors for success after the end of treatment and at 12~          months after the reimplantation of the prosthesis.~   "
202935|NCT00906035|"~     This research study will evaluate the effects of aspirin and dipyridamole alone and in~     combination on the blood flow in the vessels of the legs. We will examine how these~     medications are able to inhibit the clotting of platelets in the vessels of patients with~     PAD, and thereby affect the blood flow in the legs. Platelets are cells in the blood that~     have the ability to adhere to each other to form clots.~   "
202936|NCT00906022|"~     The clinical investigation is a prospective, international, multi-centre, randomized (1:1)~     trial with follow up investigations at 1, 3, 6 and 12 months. Patients will be randomized~     either to treatment with stenting with the Astron Pulsar SE (4 or 5 mm diameter) stent or to~     PTA with optional bailout stenting in case of PTA failure.~      The primary objective of this study is to show clinical improvement in the outcome of~     patients with symptomatic critical limb ischemia or severe intermittent claudication~     (Rutherford 3, 4, 5) treated with the Astron Pulsar SE (4 or 5 mm diameter) in comparison~     with PTA or optional bailout stenting in case of PTA failure.~   "
202937|NCT00905996|"~     In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection~     will be better than both beta-blocker therapy and no treatment in prevention of gastric~     variceal bleed. The investigators conducted a randomized controlled trial in patients with~     gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with~     cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed~     from gastric varices.~   "
202938|NCT00905983|"~     Lung cancer is one of the most common malignancies worldwide and the leading cause of~     cancer-related deaths in Western countries. Standard treatment for patients with good~     performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based~     chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to~     platinum related toxicities. Several drugs with novel mechanisms of action and significant~     activity in NSCLC have been developed; including docetaxel and gemcitabine that are also~     active in patients previously treated with cisplatin-based regimens and have a more favorable~     toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports~     its use as first-line chemotherapy, especially in patients with severe comorbidities as~     elderly patients. To improve the therapeutic index of this combination, the investigators~     performed a study with biweekly gemcitabine and docetaxel in elderly patients.~   "
202964|NCT00905632|"~     The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week~     combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C~     virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected~     patients.~   "
202992|NCT00905268|"~     The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in~     12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised~     placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures~     of neurological impairment and function, and measures of the heart.~   "
202939|NCT00905970|"~     It is traditionally considered that the development of Latent Tuberculosis Infection (LTBI)~     is due to the M. tuberculosis ability to develop a dormancy state within well-structured~     lesions (granulomas), which can remain in the lung of the host even for life. A new original~     hypothesis has been developed in the Experimental Tuberculosis Unit based on scientific~     evidence that take into account the idea that a lesion cannot be held forever, because the~     host tends to remove any lesion in order to rebuild the original parenchyma, in a healing~     process. Even if M. tuberculosis can remain in a dormant/non-replicating state for a long~     period, this is an important but not sufficient factor to explain the LTBI. The Dynamic~     Hypothesis tries to explain the existence of LTBI in spite of the healing process that could~     remove it by a constant reinfection of the host's tissue. While the Static view defends the~     induction of active TB after the reactivation of the bacilli from and old lesion; while the~     Dynamic view wants to demonstrate that there is a constant induction of new granulomas. In~     case one of these new lesions takes place in the upper lobe privileged zone, the possibility~     to induce a cavity would appear, developing an active Tuberculosis (TB).~   "
202940|NCT00905957|"~     The purpose of this study is to evaluate the efficacy of a local anaesthetic injection in the~     plane between the abdominal muscles in reducing the amount of pain relief required after~     surgery.~   "
202941|NCT00905944|"~     The investigators will evaluate the effects of an exercise program (walking on a treadmill)~     on the physical performance, the cardiorespiratory function, the proclivity to heart~     arrhythmias and the quality of life of patients with severely impaired left ventricular~     function and a bi-ventricular resynchronization pacemaker.~   "
202942|NCT00905931|"~     In this study the investigators wish to explore the potential neuroprotective effects of~     acute oral supplementation of lycopene, a natural anti-oxidant derived from tomatoes, on~     cerebral vasospasm and autoregulation, and examine whether any improvements translate into a~     reduction of biochemical markers of vascular injury and inflammation a decrease in the~     prevalence of secondary strokes following subarachnoid haemorrhage.~   "
202943|NCT00905918|"~     RATIONALE: Vitamin E may help prevent the development of cancer. Studying samples of tissue~     from patients with colorectal cancer who receive Vitamin E before undergoing surgery in the~     laboratory may help doctors learn more about how Vitamin E changes biomarkers related to~     colorectal cancer.~      PURPOSE: This randomized early phase I trial is studying giving vitamin E supplements to see~     how it affects biomarkers in patients undergoing surgery for colorectal cancer.~   "
202944|NCT00905905|"~     During acute coronary syndromes (ACS), the generation of inflammatory mediators negatively~     influences arterial wall remodeling and the endothelium-dependent vasomotor function in the~     coronary and systemic arterial systems. In fact, the intensity of the inflammatory~     upregulation is strongly related to the incidence of recurrent coronary events. The~     investigators previously demonstrated that high dose potent statins can rapidly reduce plasma~     levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. In~     addition, such statin treatment attenuates the post-discharge endothelial dysfunction of~     these patients. By inference, it is plausible to hypothesize that these beneficial effects~     during ACS may be intensified by an additive lowering of plasma cholesterol through the~     treatment with ezetimibe. So far, data is unavailable to verify this assumption. In parallel,~     data from animal models have suggested that both statins and ezetimibe may reduce insulin~     sensitivity by their effect on cholesterol content and, by this way, on insulin signaling in~     liver cells. In this context, the present study aims to investigate the role of the addition~     of ezetimibe upon statin treatment on stress-induced insulin resistance and on the~     time-course of the inflammatory response during the acute phase of myocardial infarction and~     its late effect on endothelium-dependent arterial dilation.~   "
202945|NCT00905892|"~     The purpose of this study is to determine the partitioning of exogenous lipids in the~     postprandial period while a study of overfeeding. The method is based on the incorporation of~     a stable isotopic tracer (d31_palmitic acid, d31_C16) in lipoprotein triglycerides~     (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids (FFA).~   "
202946|NCT00905879|"~     Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and~     tolerability will be assessed.~   "
202947|NCT00905866|"~     There are three specific aims in the present study:~        1. To validate the investigators' translated version of parathyroidectomy assessment of~          symptoms (PAS) questionnaire.~        2. To evaluate the impact of parathyroidectomy on health-related quality of life in the~          investigators' patients with hyperparathyroidism.~        3. To analyze the association between clinical variables and the presentation/severity of~          symptoms (and/or quality of life domains) in the investigators' patients.~   "
202948|NCT00905853|"~     This study will compare aggressive antiarrhythmic therapy to catheter ablation for~     ventricular tachycardia in patients who have suffered prior myocardial infarction. The~     purpose of this study is to evaluate the optimal management of patients presenting with~     recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy.~     The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for~     recurrent VT.~   "
202949|NCT00905840|"~     The purpose of this study is to assess the change of crestal bone level at the Titanium~     Zirconium (TiZr) compared to Titanium (grade IV) implant between surgery and 6, 12, 24, and~     36 month post surgery.~   "
202979|NCT00905437|"~     The purpose of this study is the investigate if pregabalin started a day before surgery and~     continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and~     post-operative anxiety and sleep disturbances.~   "
202980|NCT00905424|"~     To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the~     treatment of major depressive disorder (MDD) as measured by mean change in total~     Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.~   "
203010|NCT00905021|"~     The investigators want to find out if the treatments used in this study are helpful to~     patients that are diagnosed with hormone receptor positive metastatic breast cancer. The~     investigators want to also look at any side effects that could happen while patients are on~     the study treatments. The investigators want to see if there are any changes that could show~     us if your cancer is responding to the study treatments.~   "
203442|NCT00899145|"~     This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation~     carriers. Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation~     carriers may help doctors identify biomarkers related to cancer.~   "
202950|NCT00905827|"~     Suicide prevention among military Veterans has become a national priority; yet, there is a~     gap in suicide-specific intervention training for mental health students and professionals.~     The need for training in this area has become even more acute with the recent hiring by the~     Veterans Health Affairs (VHA) of thousands of clinicians to address the mental health needs~     of Veterans from all war eras. Since e-learning (online) education is more effective than~     traditional in-person (face-to-face) education for adult learners when methods, such as~     blended learning, are used, this mode of delivery may more easily meet the training and~     continuing education needs of busy medical professionals who may find it easier to fit online~     education into their daily schedules.~      A well developed in-person training approach known as the Collaborative Assessment and~     Management of Suicidality (or CAMS) has been recommended in systematic reviews as an~     effective tool for assessing and managing suicidality, as well as decreasing providers'~     fears, improving their attitudes, increasing their knowledge, confidence, and competence, and~     dispelling myths. The overall aims of this project were to develop an e-learning alternative~     for the CAMS program, determine its effectiveness relative to in-person CAMS training, and~     assess factors that may relate to adoption and implementation of CAMS in general and~     specifically through e-learning and in-person modalities.~   "
202951|NCT00905814|"~     The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug~     concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.~   "
202952|NCT00905801|"~     This is an experimental study of the feasibility and efficacy of CT perfusion (CTP) imaging~     (CT blood flow measurements) in subjects with non-small cell lung cancer.~   "
202953|NCT00905788|"~     According to the studies, about 80% of patients undergoing in vitro~     fertilization/intracytoplasmic sperm injection (IVF/ICSI) reach to the embryo transfer~     process, but only a few of them become pregnant.~      The cause of this difference can be due to some factors such as the endometrial receptivity,~     quality of transferred embryos and embryo transfer technique. Retained or expelled embryo(s)~     following embryo transfer is (are) one of the factors which may be effective on outcome. The~     purpose of this randomized clinical trial study is Lowering embryo expulsion following~     embryo transfer to improve outcome.~   "
202954|NCT00905775|"~     Acute renal insufficiency (ARI) represents a frequent and serious complication in patients~     submitted to cardiac surgery, and is associated with increases in time of hospitalization,~     costs, morbidity and mortality. Its incidence varies from 3.5% to 31%. The present study aims~     to evaluate renal function and oxidative stress in patients submitted to revascularization~     surgery with extracorporeal circulation (ECC), comparing targeted venous anesthesia~     controlled with propofol and inhalational anesthesia with isoflurane.~   "
202955|NCT00905762|"~     The purpose of this study is to assess the concentration of besifloxacin compared to~     gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the~     drug instilled topically into the study eye. Conjunctival biopsies will be performed at~     specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic~     suspension four times a day for 5 days.~   "
202956|NCT00905736|"~     Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain~     and disability. Treatment of the disorder is not always successful, and it often recurs or~     becomes chronic. More effective management options are required. There is evidence that~     electric microcurrent can promote tissue healing and symptom resolution in various chronic~     hard and soft tissue disorders, but few human studies have investigated its use with chronic~     tendon problems. It is an easily applied therapy with very few reports of side effects. It~     can be applied at home using a portable unit and, if it is clinically effective, may also~     prove more cost effective than other therapies.~      A clinical trial is planned to evaluate the therapy but, in the absence of relevant published~     evidence, a preliminary study is required to look for a treatment effect and inform a power~     calculation for sample size, The study is comparing the effects of two different forms of~     microcurrent treatment.~   "
202957|NCT00905723|"~     Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors~     symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual~     life and life quality. These effects can be counteracted by administration of estrogen~     therapy. However, estrogen therapy has side effects and isoflavone has been proposed as an~     estrogen substitute in reposition therapy. The aim of the randomized controlled trial is to~     evaluate the effects of isoflavone in the sex life assessed by a modified McCoy's sexual~     questionnaire.~   "
202958|NCT00905710|"~     Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is a hereditary~     disorder predisposing for colorectal cancer. To reduce the risk of colorectal cancer,~     patients undergo colonoscopy every 1-2 years. Chromoendoscopy is relatively new technique~     which improves the detection of adenomas, the precursor lesions of colorectal cancer. The aim~     of this study is to determine whether chromoendoscopy, including polypectomy of all detected~     lesions, reduces the development of colorectal neoplasia and the need for colectomy in LS~     patients.~   "
202959|NCT00905697|"~     The purpose of the present study is to investigate how the health of donors in living donor~     lung transplantation will change after transplant operations.~   "
202960|NCT00905684|"~     This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000~     patients in European countries and countries in Middle East who are newly prescribed any~     available OC. Patients will be followed up approximately 6 months after initial visit.~     Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin~     or any other OC has been made. Physicians should consult the full prescribing information for~     the respective OC before enrolling patients and familiarize themselves with the safety~     information in the product package label.~   "
202961|NCT00905671|"~     This pilot study is going to examine the hypothesis that in coronary arteries, soft lesions~     that contain lipid cores, but are not calcified or fibrotic and are located in proximity to~     side branches, are associated with side branch compromise as a result of plaque shift during~     angioplasty and stenting. Plaque characteristics will be detected by intravascular near~     infrared spectroscopy (NIRS).~   "
202962|NCT00905658|"~     RATIONALE: Learning about the effect of nutritional supplements on quality of life in~     patients receiving chemotherapy for cancer may help doctors plan the best treatment.~      PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well~     they work in improving quality of life during first-line chemotherapy in patients with~     metastatic gynecologic cancer.~   "
202965|NCT00905619|"~     An increasing number of Veterans are anticipated to develop chronic kidney disease (CKD) and~     require hemodialysis (HD) treatments as the Veteran population ages. In 2003, approximately~     290,000 US citizens were receiving HD and an estimated 19 million were affected by CKD. The~     annual growth rate is predicted to be 7% per year with 500,000 Americans receiving HD~     treatment by 2010. In 2005, approximately 2500 Veterans were receiving HD with growth~     expected to parallel that seen in the general population. Whereas Alzheimer's disease is the~     leading cause of dementia in the general population, growing evidence suggests that patients~     with advanced CKD experience cognitive deficits related to accelerated cerebrovascular~     disease. Patients with advanced CKD have been shown to have a high prevalence of sub-clinical~     cerebrovascular damage on imaging studies and a heavy burden of vascular risk factors such as~     diabetes, elevated cholesterol, and hypertension. Many of the cognitive deficits related to~     cerebrovascular disease may go unrecognized by routine measures of cognition. HD patients~     have increased number of hospitalizations, and several compliance issues ranging from~     congestive heart failure to dangerous electrolyte imbalances. Impaired cognition in this~     population is likely to have a significant impact on self-care and compliance with complex~     medical regimens. Currently, the severity and scope of cognitive impairment related to~     vascular disease is not well known in patients with advanced kidney disease. Additionally,~     the relationship between cognitive impairment and measures of self-care independence are not~     well known. Loss of independence and function secondary to impaired cognitive function is~     likely to be a significant problem for patients with advanced kidney disease. Early~     identification of functional impairment, particularly instrumental activities of daily living~     (IADL), will allow for rehabilitation intervention. Maintaining or improving functional~     independence through intensive rehabilitation could translate into better compliance and~     lower hospitalization rate among HD patients. Information obtained from this study is likely~     to heighten awareness of cognitive impairment and the functional consequences in Veterans~     with advanced kidney disease. Primary objectives are to determine:~        1. The range of cognitive deficits with emphasis on domains affected by vascular disease in~          patients with advanced CKD and those receiving hemodialysis.~        2. The associations between severity of cognitive impairment and severity of kidney~          disease.~        3. The prevalence of impaired IADLs and the level of health-related quality of life (HRQOL)~          in patients with advanced CKD and those requiring hemodialysis.~        4. The relationship or association of cognitive impairment with IADL and HRQOL.~      Secondary objective is to determine:~      1. The relationships among cerebral and carotid blood flow, carotid artery stiffness, and~     renal specific metabolic abnormalities with cognitive impairment.~   "
202966|NCT00905606|"~     The objective of this study was to compare the rate and extent of absorption of topiramate 25~     mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fasting~     conditions.~   "
202967|NCT00905593|"~     Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of~     nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico,~     which means all ongoing patients participating on [CAMN107A2109] excluding discontinued~     patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg~     b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have~     a maximum of 24 months of follow-up time.~   "
202968|NCT00905580|"~     The investigators hypothesize that pregabalin will decrease post-operative pain scores and~     analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The~     primary outcome will be acute postoperative pain, measured by a verbal numerical rating score~     (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome~     will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months~     after operation.~   "
202969|NCT00905567|"~     The objective of this study was to compare the rate and extent of absorption of topiramate 25~     mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed~     conditions.~   "
202970|NCT00905554|"~     Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of~     drug-related side effects, although it may be painful for the patient. Based on recent~     reports, the investigators designed this randomized controlled trial hypothesizing that the~     use of water irrigation versus air insufflation during the insertion phase of colonoscopy~     might increase the global tolerability of the examination and the proportion of patients~     undergoing complete colonoscopy without sedation.~   "
202971|NCT00905541|"~     3-Hydroxy-3-methylglutaryl coenzyme A-reductase inhibitors (statins) decrease apolipoprotein~     B-100-containing lipoproteins by increasing their fractional catabolic rates through~     low-density lipoproteins (LDL) receptor-mediated uptake. Their influence on hepatic secretion~     of these lipoproteins is controversial. The current study investigates whether simvastatin~     influences lipoprotein secretion.~   "
202972|NCT00905528|"~     Basal nitric oxide (NO) activity plays a pivotal role in the regulation of glomerular~     hemodynamics, and in animal experiments its alteration has been associated with morphological~     changes characteristic of diabetic nephropathy. The investigators aimed to assess in a~     prospective study: 1. basal NO activity of renal vasculature and 2. renal hemodynamics to~     examine whether impairment of basal NO activity of the renal vasculature is related to~     development and progression of diabetic nephropathy and other cardiovascular endpoints.~   "
202973|NCT00905515|"~     This study is designed to optimize calcineurin immunosuppressive regimens and evaluate~     immunological and non-immunological markers that may explain mechanistic differences in these~     agents and their effects.~   "
202974|NCT00905502|"~     The objective of this study is to evaluate the effects of 'high' versus 'low' volume~     intraoperative fluid administration (Ringer Lactate, RL) on intra- and postoperative~     parameters, in obese patients undergoing laparoscopic bariatric surgery (i.e., gastric~     bypass), in order to establish evidence-based data for perioperative fluid management in this~     patient population. Based on their experience as well as several reports in the literature,~     the investigators hypothesized that a restrictive approach to intraoperative hydration will~     reduce the incidence of postoperative complications and the recovery time of gastrointestinal~     (GI) function, and shorten hospital stay.~   "
202975|NCT00905489|"~     The primary objective is to establish the pharmacokinetic (PK) profile at steady state of~     nevirapine XR in HIV infected children from >=3 to <18 years of age. This phase I trial is an~     open-label, multiple dose, non-randomized and cross-over study. Patients who have completed~     the last visit of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP)~     until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved~     and is available by prescription in a given country; or, the patient enrolls in a~     compassionate use program. During this OEP, nevirapine XR safety and efficacy information~     will be collected.~   "
202976|NCT00905476|"~     The purposes of the present study are (1) to analyze baseline patient characteristics~     cross-sectionally, (2) to analyze the prognosis and its predictive factors, and (3) to~     examine longitudinal clinical course in patients with chronic respiratory failure receiving~     domiciliary NPPV.~   "
202977|NCT00905463|"~     The purposes of the study are (1) to analyze the baseline patient characteristics~     cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine~     the longitudinal clinical course in the lung transplant candidates in Japan.~   "
202978|NCT00905450|"~     This clinical study is being conducted to identify the most effective drug concentration and~     dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of~     inflammation following cataract surgery.~   "
202981|NCT00905411|"~     The increasing prevalence of childhood overweight has been found to be related to decreased~     levels of physical activity (PA) and increased energy content of the diet. Childhood offers~     an opportunity to develop and support health-promoting behaviors. Pacific Kids DASH for~     Health (PacDASH) is a community-based intervention that links food, PA, and health, and~     targets overweight children in Hawaii with a goal of preventing further weight gain.~     Components of the intervention include a food and PA prescription delivered by physicians at~     community-based health centers complemented with a toolbox of activities, behaviorally~     tailored messages, and PacDASH educational materials. This project will extend and apply the~     nationally recommended DASH eating pattern to children and the growing population of Asians~     and Pacific Islanders. The investigators will incorporate culturally preferred foods,~     recipes, and PA messages that meet DASH and other national guidelines. The approach will~     target child food behaviors and social and environmental cues that are important to making~     healthy food and PA choices and will provide steps to behavior change. Farmers markets at~     participating health centers are a support resource for activities. Providing access to,~     coupons for, and guidance about selecting and preparing fresh fruits and vegetables at a~     convenient health center farmers market will support increased intake of nutrient-rich foods~     among these children who are overweight and at risk for obesity.~      Pacific Islanders are among the world's most obese populations while Asians, although of~     relatively low body mass index (BMI), carry much of their body fat in the upper body and~     exhibit greater health risk at the same BMI. Through this project, the investigators hope to~     learn more about body size and composition in children of the Pacific Region for whom there~     are few national data. In addition, evaluate the effectiveness of a community-based~     intervention within a health care system on managing overweight in children.~   "
202982|NCT00905398|"~     Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster~     region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor~     prognosis with standard chemotherapy. The prognosis seemed to improve following the adition~     of imatinibe, a BCR-ABL inhibitor, to the treatment but still a substantial amount of~     patients relapse or progress during treatment.~      Nilotinib is a BCR-ABL inhibitor more potent than imatinib. It has been shown to be effective~     against most of the cells that bear mutations of the BCR-ABL protein leading to resistance to~     imatinibe.~      The investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy~     for acute lymphoblastic leukemia (ALL) will translate into more rapid BCR-ABL reduction and~     effectiveness against imatinib-resistant clones leading to less relapses and better survival.~   "
202983|NCT00905385|"~     The purpose of this study is to learn more about the safety of Haemophilus (H.) influenzae,~     its ability to produce adverse reactions and to live in the nose and throat. The nose and~     throat of healthy adults will be populated with a specific type of H. influenzae Nontypeable~     Haemophilus influenzae (NTHi) 2019 Streptomycin Resistant (StrR) number 1. Researchers will~     study whether the germ settles in the nose and throat, whether it causes symptoms after it~     has been placed in the nose, how long the germs last in the nose and throat, and whether the~     body tries to produce a permanent defense to the germ. Volunteers will receive a lower dose~     (3,200 germs) or a higher dose (32,000 germs). Active participation will last about 28 days,~     including a 3 night hospital stay, additional follow-up visits, followed by a 6 month~     follow-up phone call. Study procedures will include blood samples, saliva samples, several~     nose washes and throat swabs.~   "
202984|NCT00905372|"~     Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized~     by progressive decline in cognitive function and ability to perform activities of daily~     living, and ultimately can lead to death due to complications of the disease. AD is thought~     to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid~     plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase~     clearance, might be expected to slow the progression of AD.~      LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1)~     monoclonal antibody being developed for the treatment of AD. The primary hypothesis being~     tested is that LY2062430 will slow cognitive and functional decline in AD as compared with~     placebo. Each patient's participation will last approximately 19 months. Patients taking~     approved AD medications may participate in this study and continue taking these medications~     during the study.~   "
202985|NCT00905359|"~     The objective of the NICE study is to provide clinical evidence proving that the Aperius™~     PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to~     clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with~     Neurogenic Intermittent Claudication, relieved by flexion.~   "
202986|NCT00905346|"~     The objective of this study was to compare the rate and extent of absorption or topiramate 25~     mg capsules (test) versus Topamax® (reference) administered as the content of 2 x 25 mg~     capsules mixed with applesauce under fasting conditions.~   "
202987|NCT00905333|"~     The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations~     of candesartan and felodipine in a combination package comparing with the fasting intake of~     commercial formulations of both Atacand ® and Splendil®~   "
202988|NCT00905320|"~     This is a randomized study between two accepted techniques of mesh fixation for laparoscopic~     hernia repair.~   "
202989|NCT00905307|"~     This will be a multicenter, randomized, double-blind, placebo-controlled study designed to~     assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment~     of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20~     mg) is included as a positive control to confirm the assay sensitivity of the study. A total~     of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to~     obtain approximately 450 randomized subjects.~   "
202990|NCT00905294|"~     The purpose of this research is to determine the relationship between proteins and enzymes in~     the blood and how they work with platelets to form blood clots in patients with coronary~     artery disease. The investigators hypothesize that the relationship between these factors~     could potentially be useful in identifying patients at higher risk for heart attacks.~   "
202991|NCT00905281|"~     The purpose of this study is to assess the impact of systematic clinical cancer~     department/supportive care department consultation meetings, versus standard care, on the~     prescription of an additional line of chemotherapy in patients with metastatic breast cancer~     and visceral involvement after 3 or 4 lines of chemotherapy.~      This is a prospective paucicentric open label randomized controlled study with 2 parallel~     arms.~      Eligible patients will be randomly assigned to either arm Study group or Standard care.~      The number of patients required to demonstrate a 30% reduction of the number of prescriptions~     for an additional line chemotherapy, assuming an alpha risk of 5% and 80% power, is 100 (50~     in each arm).~   "
203024|NCT00904839|"~     The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in~     combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line~     patients with metastatic colorectal cancer.~   "
202993|NCT00905255|"~     The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) used~     as 2-step initiation regimen and 1-step initiation regimen in Japan, over a period of 24~     weeks of treatment, followed by an extension up to Week 76.~      The primary objective of this study is to evaluate the safety of lixisenatide once daily~     treatment in monotherapy at Week 24 by a descriptive comparison of a 1-step initiation and a~     2-step initiation regimen in patients with type 2 diabetes in Japan.~      The secondary objectives are to assess the overall safety of lixisenatide once daily~     treatment in monotherapy at Week 52 and Week 76; to assess the effects of lixisenatide on~     glycosylated hemoglobin (HbA1c) reduction at Week 52 and Week 76, body weight, and fasting~     plasma glucose (FPG); to assess pharmacokinetics (PK) and anti-lixisenatide antibody~     development.~   "
202994|NCT00905242|"~     The purpose of this study is to determine whether maintenance renal transplant patients~     receiving Myfortic can reduce or discontinue GI prophylaxis medications.~   "
202995|NCT00905229|"~     It is well known that femoral neck fractures carry a significant increase in patients'~     mortality and that surgical intervention is the preferred treatment.~      Any delay in operating on such patients would inevitably increase their risk of developing~     complications. One of the reasons for such unintentional delay would be the hypercoagulative~     status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with~     Vitamin K for patients who need urgent operation. The aim of this study is to compare~     different roots and doses of Vitamin K.~   "
202996|NCT00905216|"~     The objective of this study is to verify, through a randomized, single-blind, multicentre,~     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in~     patients undergoing heart surgery that require the aid of cardiopulmonary bypass. The~     effectiveness will be determined through the control of hemostasis during and after surgery,~     based on the strengths of markers of coagulation trichloroacetic acid (TCA), alpha-tocopherol~     transfer protein (TTPA), Anti-Xa, heparin bioavailability and excessive loss of blood~     (bleeding) at the end of the surgery.~   "
202997|NCT00905203|"~     The purpose of this study is specifically to investigate (1) the exercising muscle~     oxygenation response in diabetic postmenopausal women; (2) the dose-response of different~     physical activity interventions on skeletal muscle oxygenation response; (3) the related~     mechanisms of training effects.~   "
202998|NCT00905190|"~     This study is to assess the effect of food on a single dose of EUR-1025 when taken with a~     meal and taken on an empty stomach.~   "
202999|NCT00905177|"~     The goal of this research study is to develop better dosing of anticoagulation medication in~     both Caucasian and African Americans through analysis of various genetic factors.~   "
203000|NCT00905164|"~     The objective of this study was to compare the rate and extent of absorption of topiramate 25~     mg capsules (test) versus Topamax® (reference) administered as 2 x 25 mg capsules under~     fasting conditions.~   "
203001|NCT00905151|"~     Current methods to assess kidney function have not been tested in people who have HIV/AIDS~     population. Given effects of the disease as well as potential effects of the medications, it~     is possible that the methods currently used to assess kidney function are not accurate. This~     purpose of this study is to evaluate methods to assess kidney function the HIV population.~     The investigators hypothesize that tenofovir causes a decrease in the secretion of creatinine~     which would cause an elevation in blood levels without affecting actual glomerular filtration~     rate (GFR).~   "
203002|NCT00905138|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)~     and multiple (MD) oral dose of GLPG0259 compared to placebo.~      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple~     oral administration will be evaluated, and, if applicable, the maximum tolerated dose~     determined.~   "
203003|NCT00905125|"~     In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or~     hospitalization. In the United States (US) it is recommend that all women get flu vaccine if~     they are going to be pregnant or deliver during the flu season but only a few studies have~     measured a pregnant woman's immune response (the body's defense against the flu) after~     getting the flu vaccine. About 200, 18-39 year old, inclusive, pregnant women in their second~     or third trimester (from 14 weeks of gestation to term, inclusive) will be enrolled in this~     US based study. Participation will be about 8 months in duration. Women will be randomized~     (assigned by chance) to receive either Fluzone® or Fluarix®. Blood collection will occur on~     Day 0 and 28 days post vaccination.~   "
203004|NCT00905112|"~     The investigators propose such a trial to compare a Musculoskeletal and Obstetric Management~     (MOM) program to standard obstetric care alone for lower back pain/pelvic pain (LBP/PP)~     during and after pregnancy.~   "
203005|NCT00905086|"~     RATIONALE: Gathering information about psychological and social adjustment after radiation~     therapy in patients with cancer may help doctors plan the best treatment.~      PURPOSE: This clinical trial is studying psychosocial adjustment after radiation therapy in~     patients with breast cancer, colorectal cancer, lung cancer, or prostate cancer.~   "
203006|NCT00905073|"~     The purpose of this study is to determine whether treatment with low dose cyclosporin and~     methotrexate can inhibit the development of new onset diabetes mellitus~   "
203007|NCT00905060|"~     The Phase 2 trial is a single-arm investigation designed to evaluate safety, survival, and~     immune response in patients treated with an autologous tumor-derived heat shock protein~     peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly~     for 4 consecutive weeks and monthly following standard treatment with radiation and~     temozolomide.~   "
203008|NCT00905047|"~     The scope of the trial is to determine the preference of patients, after randomization and~     cross-over, for one of the two treatments.~      Another objective of the trial is to assess and compare the safety of each treatment.~   "
203009|NCT00905034|"~     This goal of this clinical research study is to learn if the combination of methotrexate,~     pegylated-L-asparaginase, vincristine, and dexamethasone (also rituximab in some patients)~     can help to control ALL that has not responded to previous treatment or has come back after a~     response or chronic myeloid leukemia (CML).~   "
203025|NCT00904826|"~     The purpose of this study is to determine if the drug eculizumab reduces the attack rate and~     improves outcome in patients with neuromyelitis optica.~   "
209343|NCT00820794|"~     The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of~     lithium by co-administering both drugs to healthy adults.~   "
203011|NCT00905008|"~     The FReIburger STent Registry (FRIST) is designed to determine the long term safety and~     efficacy of Drug Eluting Stents (DES) in a real-world patient population requiring stent~     implantation.~      FRIST included patients treated with DES and bare-metal stents (BMS) in the University~     Hospital of Freiburg, Germany, according to a non-restrictive inclusion criterion, in which~     virtually all consecutive patient subsets were considered eligible.~   "
203012|NCT00904995|"~     Objectives:~      To investigate the relationship between the administration of intravenous (IV) and oral~     voriconazole (vori) and the occurrence of false positive (1,3) beta-d- glucan (BG) relative~     to the standard assessment criteria used to diagnose invasive fungal infection in patients~     with hematologic malignancies.~   "
203013|NCT00904982|"~     The purpose of this research study is to see if a lottery which provides the opportunity to~     win money, a reminder system using a Med-eMonitor, or the combination of both might be~     useful in helping patients to achieve better control of their anticoagulation therapy.~     Selection for the arms of the study is randomized by the study computer. Some will~     participate in the daily lottery only, some with the reminder system only, some with the~     reminder system and the daily lottery, and some with neither the lottery nor the reminder~     system.~   "
203014|NCT00904969|"~     The purpose of this study is to obtain surgical technique data for use in physician education~     and training and to collect early clinical outcomes data for future publication.~   "
203015|NCT00904956|"~     It is traditionally considered that someone with a positive tuberculin skin test (TST)~     (and/or positive result in Cell Interferon-Gamma Release Assay (TIGRA), depending on the~     different countries' guidelines) is infected but not ill when the absence of lesions is~     demonstrated in a thorax X-Ray assay. Even though, the experiences described in literature~     using cows and pigs as animal models for the study of LTBI demonstrate the presence of this~     kind of lesion in the animals, even too small to be detected by X-Ray assay, which would~     suggest they also could happen in human LTBI. Nowadays, the High Resolution Scanners (HR TC)~     offer the possibility of detecting any lesion approximately 1 mm in diameter, so the~     investigators plan to use this technique to screen people already infected by M. tuberculosis~     (but not ill, following the Diagnosis Standard Guidelines).~      Additional pathological analysis of resected and post-mortem tissues will provide~     lesion-based profiles of humans infected with tuberculosis.~   "
203016|NCT00904943|"~     The objective of this study was to compare the rate and extent of absorption of topiramate 25~     mg capsules (test) versus Topamax® (reference) administered as 2 25 mg capsules under fed~     conditions.~   "
203017|NCT00904930|"~     Background/Aims: The Periotest® method represents a technique for objective tooth mobility~     assessment. The aims of this study were: 1. receiving information about normal Periotest®~     values in vertical and horizontal dimension on periodontally healthy teeth for individuals~     aged 20-35, 2. investigating the reliability of the Periotest® method in terms of~     intra-serial and inter-serial reproducibility before splinting and with an applied dental~     trauma splint, 3. evaluating the splint effect of two different wire-composite splints in~     vivo.~      Materials and Methods: On periodontally healthy dental students (n=33; mean age 24.7 years)~     Periotest® values were measured on reproducible measuring points, in vertical and horizontal~     dimension and before splinting and after splint insertion. Three readings were taken per~     serial to observe the intra-serial reproducibility, and for testing inter-serial~     reproducibility three serials were measured (Friedman-test; P ≤ 0.001). Two different~     wire-composite-splints (1 = Dentaflex 0.45 mm, 2 = Strengtheners 0.8x1.8) were inserted, the~     Periotest® values were measured and the splint effects were calculated and compared~     (Whitney-Mann-U-test; P ≤ 0.001).~   "
203018|NCT00904917|"~     The purpose of the study is to adapt and test the Preventive Intervention Project for urban~     African American mothers with depression and their children.~   "
203019|NCT00904904|"~     This study is being conducted to show that indomethacin is at least as effective as ketorolac~     for the prevention of ocular inflammation following cataract surgery.~   "
203020|NCT00904891|"~     This study will test the effectiveness of two programs for preventing depression in~     adolescents.~   "
203021|NCT00904878|"~     A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with~     Inflammatory Bowel Disease study is being conducted at the University of California San~     Francisco and 30 other sites around the United States who are part of the CCFA Clinical~     Alliance. The aim of this study is to determine the effect of medication use and disease~     activity on the outcome of pregnancy among women with IBD up to 4 years from birth.~   "
203022|NCT00904865|"~     Background:~      Single port access surgery is a rapidly progressing surgical approach which allows~     performance of standard laparoscopic surgery through a single transparietal port instead of~     multiple port accesses.~      Objective:~      Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple~     ports laparoscopic cholecystectomy.~      Hypothesis:~      SPA cholecystectomy is associated with decreased parietal and body image trauma compare to~     multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with~     better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA~     cholecystectomy may also be associated with decreased rate of parietal complications as lower~     numbers of transparietal port are placed.~      Methods:~      All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in~     the study will have recognized biliary pathology for which formal indication cholecystectomy~     are recognized internationally.~      Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy,~     will be the same except, that one surgical technique is achieved through a single~     transparietal port and the other through multiple ports.~      Randomization will be performed before surgeries after patients have given their informed~     consent to the study.~      No specific test or cost will be necessitated by the study. Patients will be informed orally~     and will receive a short study summary, allowing them to give an informed consent.~      Endpoints:~        -  Morbidity~        -  Body image and Cosmetic results~        -  Post-operative pain (opioid sparing effect)~        -  Operative time~        -  Hospital stay~   "
203023|NCT00904852|"~     This is a safety study of tandutinib in combination with temozolomide and bevacizumab after~     people have received radiation therapy and temozolomide treatment. This study will determine~     the maximum safe dose of tandutinib when combined with temozolomide and bevacizumab and~     evaluate the safety of the combination treatment.~   "
203026|NCT00904813|"~     There are theoretical reasons to believe that radiotherapy (RT) given in larger fractions~     during a shorter period of time might result in more late side effects than giving a~     conventional, more protracted RT in patients with rectal cancer. In addition, the optimum~     timing of surgery after RT, with respect to postoperative morbidity, mortality and potential~     downsizing of the tumour is not known.~      To address these questions, a prospective randomized multicentre trial was initiated, the~     Stockholm III trial, in which patients with primarily resectable rectal cancer were~     randomized to short-course preoperative RT (5x5 Gy) followed by surgery within one week or~     after 4-8 weeks or long-course preoperative RT(25x2 Gy) followed by surgery after 4-8 weeks.~   "
203027|NCT00904800|"~     This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.~   "
203028|NCT00904787|"~     To define the maximum tolerated dose of oral daily ENMD 2076 in patients with relapsed or~     refractory hematological malignancies~   "
203029|NCT00904774|"~     Despite considerable obstetric and neonatal advances in the care of very low birth weight~     (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of~     surviving infants, and new ways for combatting this disease must be found. BPD appears to~     result from arrested lung development, but its etiology has not yet been fully established.~     Besides the role of the exposure of the immature lung to injurious factors in the development~     of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking~     advantage of new genomic technologies, the objective of the investigators' project is to~     identify predisposing human genetic variants through:~        1. a genome-wide association (GWA) study in VLBW neonates,~        2. a candidate-gene association study, including selection of single nucleotide~          polymorphisms (SNPs) found in (a) and~        3. functional studies of any SNP found to be convincingly associated with BPD in (a) and~          (b).~   "
203030|NCT00904761|"~     This study aimed to investigate effects of physical training on exercise capacity and changes~     of heart rate variability (HRV) at rest, during exercise, and post-exercise in the patient~     with diabetes with autonomic neuropathy (DAN).~   "
203031|NCT00904748|"~     The purpose of this study is to perform a relative bioavailability study between two~     formulations of sildenafil citrate.~   "
203032|NCT00904735|"~     RATIONALE: Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. It is not yet known whether hydroxyurea is more effective when given alone~     or together with imatinib mesylate in treating patients with meningioma.~      PURPOSE: This randomized phase II trial is studying how well hydroxyurea works compared with~     giving hydroxyurea together with imatinib mesylate in treating patients with recurrent or~     progressive meningioma.~   "
203033|NCT00904722|"~     The goal of this clinical research study is to learn if the combination of the immunotherapy~     drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug~     combination will also be studied.~   "
203034|NCT00904709|"~     Many women have heavy periods and this can be associated with low blood, tiredness and~     inability to carry out normal activities. Approximately 10-30% of these women will have an~     underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used~     and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects~     and they are more common at higher doses. In the medical literature, there are different~     dosing schedules and there is one commonly recommended in Canada. Women with underlying~     bleeding disorders may require higher doses of this medication compared to those who do not.~     In this study, the investigators want to find the lowest effective dose of tranexamic acid~     for girls and women with heavy periods who have bleeding disorders and the investigators~     think this will be lower then the usual recommended dose. If the investigators' results~     support this, it may contribute to changing how the investigators presently prescribe this~     medication and may provide a better option for women with heavy periods in particular those~     with bleeding disorders. The investigators have just started a Women with Bleeding Disorders~     Clinic and hope that this project will lead to better care for the patients and more research~     in the future.~   "
203035|NCT00904696|"~     Irritable bowel syndrome (IBS) is a very common chronic functional gastrointestinal disorder~     characterised by abdominal pain/discomfort, bloating and alterations in bowel function. This~     condition significantly impairs quality of life and places a large burden on health care~     resources. Existing therapies for IBS are far from being satisfactory and new therapies are~     being constantly sought.~      The pathogenesis of IBS remains unclear. Imbalance in the intestinal microbiota is considered~     to be one important etiologic factor for IBS. That some probiotics are effective in the~     prevention and treatment of IBS supports this idea.~      Progut is a synbiotic: a combination of probiotics and prebiotics. Probiotics are viable~     beneficial bacteria that are normally present in a healthy digestive tract. Each capsule of~     Progut contains 9 billion viable bacteria from 8 different strains that are characteristics~     of a healthy normal gut microflora: Lactobacillus (L. acidophilus, L. casei, L. lactis, and~     L. bulgaricus); Bifidobacterium (B. longum, B. infantis and B. bifidum); and Streptococcus~     thermophilus at time of manufacturing. To ensure survival of these bacteria, Progut is~     encapsulated and enteric-coated.~      The primary objective is to evaluate the tolerability of Progut treatment 1-3 capsules/day in~     patients with irritable bowel syndrome under the same conditions as those likely to be~     encountered in a standard general clinical practice or outpatient clinic.~      The rationale for this study is to obtain tolerability data in patients with IBS in the~     Singapore. The secondary objectives are to evaluate the patients' satisfaction and symptom~     improvement with Progut treatment.~   "
203048|NCT00904527|"~     The purpose of this study is to determine whether relaxation (autogenic training of Schultz)~     is effective in treatment for migraine.~   "
203049|NCT00904514|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at previously collected and stored tissue samples~     from patients previously enrolled in a completed National Cancer Institute clinical trial.~   "
203094|NCT00903916|"~     The purpose of this study is to evaluate changes in appetite-regulating hormones, body~     composition (weight, body fat%), and hunger ratings in persons early in treatment with one of~     four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).~   "
203036|NCT00904683|"~     Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized~     by progressive decline in cognitive function and ability to perform activities of daily~     living, and ultimately can lead to death due to complications of the disease. AD is thought~     to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid~     plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase~     clearance, might be expected to slow the progression of AD.~      LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1)~     monoclonal antibody being developed for the treatment of AD. The primary hypothesis being~     tested is that LY2062430 will slow cognitive and functional decline in AD as compared with~     placebo. Each patient's participation will last approximately 19 months. Patients taking~     approved AD medications may participate in this study and continue taking these medications~     during the study.~   "
203037|NCT00904670|"~     The objective of this study was to establish that an optimal dose of Quillivant XR oral~     suspension would result in a significant reduction in signs and symptoms of ADHD compared to~     placebo treatment in pediatric patients ages 6-12 years with ADHD.~   "
203038|NCT00904657|"~     The study is conducted:~        -  to investigate the influence of sunitinib (study drug) on the plasma biomarkers VEGF-A,~          VEGF-C, soluble VEGFR-2, and soluble VEGFR-3 (vessel endothelial growth factors) and on~          the blood pressure;~        -  to generate a pharmacokinetic/pharmacodynamic model for sunitinib using biomarkers.~   "
203039|NCT00904644|"~     Since June 2007, raltegravir has been available in Switzerland within a named patient program~     for patients who have virologic failure, triple class experience and resistance, and no other~     treatment options. This proposal has been designed to evaluate efficacy and safety data among~     patients who receive raltegravir within the routine clinical practice in Switzerland and who~     participate in the Swiss HIV Cohort Study. This is a combined retrospective analysis of~     patients who already received raltegravir and a prospective part of patients who enter the~     named patient program and will be followed up in a standardized way. In the prospective part,~     patients will also be able to receive raltegravir in case of intolerance to their current~     medication with virologic suppression.~      The analysis will primarily use descriptive statistics. In addition, we will assess the~     duration of virologic response and focus on predictors of HIV RNA suppression during a~     follow-up of at least 6 months. In the prospective part, we will assess trough plasma levels~     of raltegravir and other antiretrovirals. In patients who will develop virologic failure,~     genotypic and phenotypic resistance to raltegravir (and other antiretrovirals) will be~     performed to characterize the evolution of resistance during the raltegravir-containing~     regimen.~   "
203040|NCT00904631|"~     Name of Device: Eraser Tattoo Removal Device~      Device Description: The Eraser device is a mechanical device, resembling tattoo devices but~     with an innovative mechanism for dripping treatment fluid over reciprocating needles and~     returning used fluid into a reservoir chamber. The device is intended for removal of tattoos.~      Objectives: This study is a continuation of a previous feasibility study, which tested the~     ability of the device to remove tattoos from small skin areas. The purpose of this study is~     to evaluate the safety and effectiveness of the Eraser Tattoo Removal system for removal of~     skin tattoos in their entirety.~      Subject Population: 20 patients in the medical center. Subject enrollment will include (i) a~     variety of tattoo colors (multiple colors) (ii) a variety of tattoo composition, contour~     lines and shadings (iii) Subjects with different skin colors (white, tanned, dark, etc…) (iv)~     professional and amateur tattoos.~      Structure: A prospective, non-randomized, open, clinical study designed according to FDA~     guidelines; ISO 14155: standard for clinical studies of medical devices; and the procedures~     of the Israeli Ministry of Health for clinical studies.~      After informed consent is signed, demographic details and medical history will be taken and a~     physical examination performed. Subjects will be treated with the Eraser device, using~     salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo~     area will be photographed. The Eraser device will be used to remove the tattoo from the~     entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put~     on the treated area for one-hour post treatment. After Care Treatment, based on a~     Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of~     antibiotic ointments in case of infection). All subjects must refrain from exposure to the~     sun for 90 days following each treatment.~      Follow-up: The subject will return for follow-up at one week, two weeks, 1 month and two~     months (if tattoo removal and skin healing is complete), or up to six months (if skin~     healing/ tattoo removal are not complete by two months), or until the healing of the tattoo~     removal site is completely resolved or until the investigator determines that additional~     treatments will provide no further benefit to the patient. In each follow-up visit, a~     physician will perform a physical examination, check the skin over and around the treatment~     area, and take photographs of the treated area. Images from last follow-up will be compared~     with images of the same site taken before the removal procedure, for evaluation of treatment~     efficacy and safety.~      Repeat treatments: if tattoo removal is not complete, up to two additional treatments will be~     performed, based on the investigator's discretion. After each treatment, follow-up will~     continue as described above.~      Blinding: Non-Applicable Concurrent Control: There is no concurrent control group in this~     study. Images of tattoos before treatment will serve as the reference measure, to which~     images of healed skin, several weeks after tattoo removal, will be compared.~      Sample Size: 20 subjects will be enrolled in the study. Primary Effectiveness Variables: The~     primary measure of effectiveness will be the pigment clearance, as evaluated by image~     comparison on a 1-5 analog scale (5 - 81-100% clearance- excellent removal; 4 - 61-80% - good~     removal; 3 - 41-60% - moderate removal; 2 - 21-40% - fair removal; 1 - 0-20% - poor removal).~     Effectiveness will be calculated for the total study group and for individual sub-groups~     (skin type, pigment colors, etc.). Effectiveness will be analyzed separately for the area~     affected (percentage of treated area that showed any reaction to treatment) and for the~     change in color brightness (if, due to technical reasons, part of the tattoo showed a major~     effect, this area will be evaluated for the change in color brightness). For both analyses,~     the same scale will be used.~      For safety assessment, the rate of systemic and dermatologic adverse events will be~     calculated and reported. The data will be listed by type of event and by severity.~     Specifically, textural change, hypo- and hyper- pigmentation will be followed and their rates~     calculated.~      Data Analysis: For this clinical study, descriptive statistics will be used. Successful~     treatment will be a result of 3 or more (at least, moderate tattoo removal) on the brightness~     change scale.~      Study Sponsor: Hawk Medical Technologies Ltd.~   "
203041|NCT00904618|"~     The objective was to observe the satisfaction of local anesthesia during the implantation of~     the TVT-SECUR for the treatment of stress urinary incontinence, with the use of~     questionnaires completed by the patients, and to evaluate the short-term efficacy and safety~     of the sling, with a comparison of the two techniques of implantation: the 'U-Method' and the~     'Hammock' technique.~   "
203042|NCT00904605|"~     Patients with unilateral or bilateral osteoarthritis of the knee participated in a Phase IV~     clinical trial to assess the efficacy of Lidoderm compared with celecoxib 200mg in treating~     pain from osteoarthritis of the knee.~   "
203043|NCT00904592|"~     1. Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic~          Retinopathy.~        2. Objectives of study: To evaluate the Intervention effect of integrate control protocol~          on reducing the incidence rate of proliferative diabetic retinopathy, PRP and MVL. Then~          produce a high performance, optimize, convenient, applicable and demonstrated protocol~          of integrate control with Intervention of TCM and west medicine.~        3. Study Type: Interventional~        4. Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes~          Assessor), Parallel Assignment, Positive controlled clinical study.~        5. Sample size: 480 subjects , divided into test and control groups equally.~        6. Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal~          photocoagulation~   "
203044|NCT00904579|"~     Background:~        -  Solid organ transplantation provides life-saving treatment for end-stage organ disease~          but is associated with an increased cancer risk because of the need for long-term~          immunosuppression~        -  End-stage renal disease (ESRD), the most common type of end-stage organ disease leading~          to transplant, is itself linked to increased risk for some cancers~        -  The role of immunosuppression and other factors causing cancer in this setting are not~          fully understood.~      Objectives:~        -  To characterize cancer risk in transplant recipients and identify risk factors.~        -  To characterize risk for transmission of cancer from organ donors to recipients.~        -  To describe cancer risk in ESRD.~      Eligibility: Patients are not required for this study. Data are gathered from existing~     databases of ESRD patients, organ transplant patients and cancer registries.~      Design:~        -  Databases of 1) U.S. transplant recipients, donors and wait list candidates and 2) U.S.~          ESRD patients will be linked to multiple U.S. cancer registries to identify cancers in~          transplant recipients and ESRD patients.~        -  The spectrum of cancer risk in transplant recipients and ESRD patients will be evaluated~          in detail.~        -  The cancer risk in transplant recipients will be examined in relation to whether the~          donors had cancer.~        -  The proposed cancer risk factors (e.g., underlying medical condition, infection with~          cancer-causing viruses, immunosuppressive medications) documented in transplant and ESRD~          files will be studied for association with increased risk of particular types of cancer.~   "
203045|NCT00904566|"~     By using gene-expression profiling, Van't Veer and colleagues developed a 70-gene prognosis~     profile, MammaPrint, to identify breast cancer patients who are at low risk of developing~     distant metastases and therefore might safely be spared chemotherapy. The aim of this study~     is to evaluate the prognostic value of the 70-gene Mammaprint profile in Japanese women with~     node-negative breast cancer.~   "
203046|NCT00904553|"~     This study is to look more closely at the tumor removed during your surgery, and to follow~     your condition after your treatment.~      The purpose of this study is to determine what side effects are common or more rare from this~     treatment, how well the treatment has worked for you, and to track whether you develop other~     brain metastases.~   "
203047|NCT00904540|"~     Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical~     trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in~     the treatment of acute and chronic LBP.~   "
203050|NCT00904501|"~     BALI (Bone marrow Autograft in Limb Ischemia) is a randomized double-blind trial comparing~     implantation of bone marrow - mononuclear cells versus placebo in patients presenting with~     critical leg ischemia and no surgical option.~      The main end point is the survival without major amputation 6 months after implantation.~      Biological studies are performed on bone marrow mononuclear cells (BM-MNC) to evaluate their~     angiogenic properties.~   "
203051|NCT00904488|"~     The purpose of this prospective, randomized, open-label study is to compare two diuretic~     strategies in patients with acute decompensated heart failure (ADHF): the addition of an oral~     thiazide diuretic to intravenous bolus (IVB) loop diuretic will be compared to transition~     from IVB to continuous infusion (CI) loop diuretic.~   "
203052|NCT00904475|"~     Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic~     treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the~     lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.~   "
203053|NCT00904462|"~     Patients with unilateral or bilateral osteoarthritis (OA) of the knee participated in a Phase~     II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo in the~     treatment of pain from OA of the knee.~   "
203054|NCT00904449|"~     The purpose of this study is to monitor the long-term analgesic effectiveness, safety, and~     utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.~   "
203055|NCT00904436|"~     Breathlessness is an extremely common and uncomfortable symptom that is reported in more than~     two-thirds of persons with tetraplegia. This disordered pulmonary function is due to~     respiratory muscle paralysis or to sympathetic denervation results in a restrictive~     impairment and airway hyperreactivity, respectively. These restrictive and obstructive~     dysfunctions have been associated with the symptom of breathlessness. However, mechanisms~     contributing to dyspnea in persons who have tetraplegia are not well understood. It has been~     demonstrated that persons with tetraplegia have an increased prevalence of breathlessness and~     may have an altered breathing pattern. The purpose of this study is to determine the~     breathing pattern at rest and measure the changes in breathing after a bronchodilator~     treatment (a medicine commonly used to treat asthma that relaxes and opens up airways). The~     determination of breathing pattern is done by measuring the movements in the chest wall while~     breathing. This design will elucidate differences in breathing patterns between those with~     tetraplegia and controls, as well as demonstrate the effect of bronchodilatation on motor~     drive and timing. Knowledge of the intraindividual variability and mean values of the~     components of the breathing pattern will improve our understanding of breathlessness in these~     individuals.~   "
203056|NCT00904423|"~     Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include~     bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might~     be beneficial in treating these symptoms and to protect bone.~   "
203057|NCT00904410|"~     18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively~     detect subclinical and clinical therapeutic responses at stages that are earlier than those~     detected by conventional approaches.~      We propose to conduct a prospective study to evaluate early therapeutic response using~     18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer~     patients.~      Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response~     evaluated after 3 cycles of chemotherapy.~      The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and~     non-responder patients.~   "
203058|NCT00904397|"~     Patients who had axial lower back pain (LBP) with or without radiation present for at least 3~     months and had daily moderate to severe LBP as the primary source of pain participated in a~     Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib~     200 mg in treating chronic axial LBP with and without radiation.~   "
203059|NCT00904384|"~     The prevalence of COPD in HIV+ and AIDS patients is unknown. The pathophysiology of HIV~     infection and COPD might be of interest to both conditions. The research hypotheses of this~     study are:~      In patients with HIV infection living in the Autonomous Community of the Balearic Islands~     (CAIB):~        1. The Prevalence of airflow obstruction in patients with HIV infection is higher than in~          the general population.~        2. In these patients, the prevalence of emphysema detected by HRCT is common (greater than~          or equal to 15%)~        3. DLCO measurement is a good marker for the presence of emphysema on CT~        4. The inflammatory response is different from that seen in patients with COPD and / or~          emphysema without HIV infection~   "
203060|NCT00904371|"~     The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood~     pressure and its ability to reduce different indicated cardiovascular risks. Further on, the~     study will evaluate the current antihypertensive treatment pattern in the daily practice~     among the patient population at increased cardiovascular risk.~   "
203061|NCT00904358|"~     To study the validity and reliability of estimation of the central venous pressure by~     measurement of internal jugular vein size using 2-dimensional ultrasound.~   "
203062|NCT00904345|"~     This is a single-arm, phase II trial to characterize the clinical outcome of standard of~     care, cetuximab concurrent with radiation, in a special population (head and neck cancer~     patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor~     performance status or concurrent illness), and to determine if biomarker response to a~     loading dose of cetuximab is predictive of that outcome.~   "
203078|NCT00904124|"~     It has been suggested that dietary fibers can affect food intake and satiation. Satiation, or~     meal termination, can be induced by sensory properties and energy density of fiber-rich food~     products, but also by the chemical/physical/rheological behavior of the fibers in the stomach~     and/or intestine. It is not clear which properties are the key regulators of satiation by~     fiber sources. There are many types of dietary fiber, which have diverse sensory and chemical~     properties, thus these might have different effects on satiation.~   "
203079|NCT00904111|"~     Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess~     the efficacy of lidocaine 5% patch compared with placebo.~   "
203080|NCT00904098|"~     Females 18 years of age or older with at least one year history of menstrual migraine (MM)~     headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan~     when used at the early stage (International Headache Society [IHS] Grade 1) of MM compared~     with patients' current treatment.~   "
203063|NCT00904332|"~     Objective~      When learning to tap to a rhythm the brain has to coordinate information from different~     senses (eyes, ears, touch). This information has to be integrated into a movement plan to~     allow a smooth, continuous performance. Two brain areas that are of particular interest for~     this task are the posterior parietal cortex that integrates sensory and motor information and~     the primary motor cortex that sends out the movement commands to the muscles. These areas~     communicate via nerve connections with each other. The goal of this research proposal is to~     examine if the strength of the connection between those areas can be changed by practicing a~     simple tapping task and if the change in connection strength depends on if the rhythms were~     shown by visual or auditory stimuli. Additionally we will investigate how the ability to tap~     rhythms relates to other cognitive abilities like problem solving.~      Study Population~      We intend to study 20 adult healthy volunteers on an outpatient basis.~      Design~      In three experimental sessions we propose to use transcranial magnetic stimulation (TMS) and~     electro encephalography (EEG) to examine the role of the posterior parietal cortex in motor~     learning. In session 1 a neurological examination will be performed and a clinical and~     anatomical MRI (Magnet Resonance Image) will be taken. Session 1 can be skipped if an MRI and~     a neurological exam have been performed at the NIH during the last year. In session 2 TMS~     will be used to examine the connection between posterior parietal cortex and primary motor~     cortex before and after rhythm training. Additionally, EEG will be recorded during the~     training session. In session 3 we will examine how the ability to tap to different beats~     relates to higher cognitive functions. We will record EEG during tapping simple beats and we~     will administer a pen and paper problem-solving test.~      Outcome Measures~      In session 2 the primary outcome measure will be change in conditioned Motor Evoked Potential~     (MEP) peak-to-peak amplitude after learning temporal motor sequences measured in the primary~     motor cortex. A secondary outcome measure will be the interregional coherence changes as~     measured by EEG during training. In session 3 the primary outcome will be performance on the~     tapping task and on the pen and paper test as well as the interregional coherence changes as~     measured by EEG during the tapping task.~   "
203064|NCT00904319|"~     Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is~     one of the most disabling problems facing the growing population of older adults. The purpose~     of this research is to reduce disablement of older adults with symptomatic knee~     osteoarthritis.~   "
203065|NCT00904306|"~     The purpose of this study is to test the feasibility and preliminary efficacy of a 6-month~     chromium picolinate (CrPic) treatment trial in binge eating disorder (BED).~   "
203066|NCT00904293|"~     The purpose of the investigators' study is to determine the clinical utility of a~     warfarin-dosing algorithm that incorporates genetic information (VKORC1 and CYP2C9 alleles)~     for adult patients initiating warfarin therapy.~   "
203067|NCT00904280|"~     The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone~     ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe~     pain.~   "
203068|NCT00904254|"~     The primary objective of this study is to proof the concept of EP 1645 as a diagnostic tool~     for carotid artery atherosclerosis and plaque instability and to assess the safety and~     tolerability of this diagnostic agent, a monoclonal antibody fragment (Fab') conjugated with~     the diagnostic radionuclide 99mTc. Safety and tolerability will be determined by adverse~     events (AEs) observed and reported upon administration of the product and the absorbed dose~     of radiation.~   "
203069|NCT00904241|"~     This research trial studies biomarkers in tumor tissue samples from patients with newly~     diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from~     patients with cancer in the laboratory may help doctors identify and learn more about~     biomarkers related to cancer.~   "
203070|NCT00904228|"~     The purpose of this research project is to ascertain the effectiveness of plastic head~     covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º~     Celsius by the World Health Organization. The surface area of the head is about 20% of total~     body surface of a newborn infant and is a major source of heat loss. The objective is to~     compare rectal temperature upon admission to the neonatal intensive care between preterm~     neonates who had stockinet head covering and those who had plastic-lined stockinet head~     covering placed in the delivery room. The investigators aim to demonstrate that plastic-lined~     head covering is more effective than stockinet head covering alone in maintaining body~     temperature.~   "
203071|NCT00904215|"~     An observational study to investigate the efficacy, safety, tolerability and the effect on~     quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in~     patients with hypertension~   "
203072|NCT00904202|"~     Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain~     syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or~     other peripheral neuropathy participated in a Phase IV clinical trial to assess the~     comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in~     treating a diverse group of peripheral neuropathic pain patients.~   "
203073|NCT00904189|"~     This study is to test the effectiveness a new method (called EPR dosimetry) that could be~     used to measure radiation doses to fingernails that occur as a result of unplanned exposure~     to radiation, such as might occur from the actions of terrorists, or from accidents.~   "
203074|NCT00904176|"~     The purpose of this study is determine that Dapagliflozin has no effect on the~     pharmacokinetics (PK) or pharmacodynamics (PD) of warfarin when dapagliflozin is~     coadministered with warfarin. Also, that Dapagliflozin has no effect on the PK of digoxin~     when dapagliflozin is coadministered with digoxin.~   "
203075|NCT00904163|"~     Recessive dystrophic epidermolysis bullosa (RDEB) is a severe inherited blistering disease~     caused by the absence of type VII collagen. Patients with RDEB develop large, severely~     painful blisters and open wounds from minor trauma to their skin. We are screening RDEB~     subjects to determine additional characteristics of patients who survive to adulthood.~   "
203076|NCT00904150|"~     The investigators hypothesize that genes that play a role in menstrual migraine can be~     identified using a well characterised migraine population and a comprehensive genome-wide~     association scan approach.~      The aim of the study is to identify genes, genetic regions, and the effect of hormones on~     expression profiles in women with menstrual migraine compared to a control population with no~     personal or first-degree family history of migraine.~      In this case control study, saliva samples will be taken from 300 cases and 300 controls for~     DNA analysis. Blood samples from 30 cases and 30 controls will be taken during the follicular~     phase as well as the luteal phase of the menstrual cycle for ribonucleic acid (RNA) analysis.~   "
203077|NCT00904137|"~     Type I supracondylar fractures are elbow fractures that occur in children aged 3-10 years.~     Many different treatment options exist to treat this type of fracture. The purpose of this~     study is to compare three different treatment modalities with regards to pain experienced~     during treatment, the amount of pain medication needed during treatment, and any short-term~     complications. We hypothesize that above elbow casting and long-arm splinting will result in~     less pain and have fewer complications than taping the elbow in flexion.~   "
203081|NCT00904085|"~     The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with~     placebo in patients with mild to moderate pain following outpatient knee arthroscopy.~   "
203084|NCT00904046|"~     This study has two aims:~      Aim 1: To determine the presence of accumulation of fat within cells and the functional~     consequences of this in the kidney by correlating kidney fat content with urine test results.~      Aim 2: The investigators will evaluate the effect of thiazolidinedione (pioglitazone) on~     excess fatty acid accumulation in kidney tissue and its correlation with uric acid stone~     formation in subjects with uric acid stones.~   "
203085|NCT00904033|"~     Both the calcitriol and exercise interventions are aimed at reducing fracture risk by~     maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and~     increasing muscle mass. Both calcitriol and exercise are efficacious in maintaining proper~     bone health and muscle mass among the general population, but little research has been done~     on breast cancer patients and survivors. The combination of calcitriol and exercise, which~     function through different but similar mechanisms, could produce interactive effects in~     reducing fracture risk among breast cancer survivors.~      Hypothesis: A combination of calcitriol along with a structured home-based walking and~     progressive resistance exercise program will be efficacious in preventing bone resorption and~     in increasing bone formation among survivors of invasive breast cancer.~      Primary Objective~      To collect data on the efficacy and feasibility of a supplementation of calcitriol~     with/without an accompanying structured home-based walking/progressive resistance exercise~     program for improving bone health among breast cancer survivors.~      Secondary Objectives~      To collect data on the efficacy and feasibility of a supplementation of calcitriol~     with/without an accompanying structured home-based walking/progressive resistance exercise~     program for increasing strength among breast cancer survivors.~      To collect data on the efficacy and feasibility of a supplementation of calcitriol~     with/without an accompanying structured home-based walking/progressive resistance exercise~     program for improving skeletal muscle mass among breast cancer survivors.~   "
203086|NCT00904020|"~     Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low~     back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin~     participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm®~     administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients~     who had a partial response to a regimen containing gabapentin.~   "
203087|NCT00904007|"~     Online interactive spaced education (ISE) is a novel educational methodology based on the~     spacing effect, the psychological finding that repeated presentations of educational~     material over spaced intervals increase learning efficiency and improve knowledge retention.~     ISE is delivered using periodic emails that contain clinical case scenarios and~     multiple-choice question. The investigators recently completed a randomized trial involving~     95 VISN 1 primary care providers (PCPs) which demonstrated that an ISE intervention can~     significantly improve clinician's practice patterns. Those clinicians randomized to the ISE~     intervention on prostate cancer screening demonstrated a 26% relative reduction in~     inappropriate screening. The investigators propose to conduct a randomized controlled trial~     involving PCPs in VISN 1 to determine whether ISE can (1) increase knowledge of the~     appropriate treatment of hypertensive patients, (2) reduce clinical inertia in hypertension~     management, and (3) improve the blood pressure control in hypertensive patients.~      Anticipated Impacts on Veterans' Healthcare: This study aims to demonstrate that online~     interactive spaced education (ISE) can improve providers' care of patients with hypertension.~     ISE is the type of intervention that can be deployed across the VHA with content tailored to~     meet specific needs and can be implemented as a tool to improve performance measures and~     clinical outcomes~   "
203088|NCT00903994|"~     Open-label study to be conducted at 2 US investigational sites in subjects who have acute~     tendonitis or bursitis of the shoulder, elbow, or knee. Eligible subjects receive treatment~     with the KTP, applied once daily at the same application site for 3 consecutive days.~   "
203089|NCT00903981|"~     The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg~     or placebo administered orally for 12 weeks in patients with erectile dysfunction. The~     efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by~     laboratory tests, vital signs, physical examination and adverse events.~   "
203090|NCT00903968|"~     The purpose of this research study is to determine the safety of plerixafor and bortezomib,~     and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma~     cells from attaching to bone marrow and has been used in other phase I studies for~     mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the~     combination of plerixafor and bortezomib is very effective in killing myeloma cells in the~     laboratory more than the effect of each drug alone.~   "
203091|NCT00903955|"~     The purpose of this research is to understand the properties of mucus in persons with COPD,~     specifically Chronic Bronchitis. We hypothesize that those with Chronic Bronchitis have~     dehydrated mucus, and thus have a harder time coughing it out of their lungs. This leads to a~     greater vulnerability for lung infection, inflammation and airflow obstruction. Ultimately,~     our goal is to understand how mucus dehydration contributes to the progression of~     COPD/Chronic Bronchitis so that better therapies and interventions can be developed for~     future generations.~   "
203092|NCT00903942|"~     For patients with stage III Lung Cancer, We propose one cycle chemotherapy using Abraxane and~     Carboplatin, followed by pulsed low-dose sensitizing Abraxane chemotherapy and daily~     Radiation. This will be followed by more hi-dose chemotherapy. We anticipate this regimen to~     target early distant microscopic spread by using one cycle of chemotherapy prior to~     radiation, and to achieve control of the disease in the lung by combining pulsed low-dose~     sensitizing Abraxane, with radiation.~   "
203093|NCT00903929|"~     Patients who undergo total body irradiation (TBI) for stem cell transplantation have~     prolonged periods of low counts of specific blood cells called platelets. These low platelets~     counts can cause bleeding and infection. Thus far, no drug is available for use to speed the~     recovery of platelets, and therefore transfusions are often necessary.~      The purpose of this study is to test the safety of a drug called eltrombopag in patients who~     have received TBI. The investigators want to find out what effects, good or bad, it has on~     people with low platelet counts due to treatment with TBI. The investigators will also be~     testing how well eltrombopag may work at different doses and determine if this drug speeds up~     the recovery of the platelets.~   "
203141|NCT00903279|"~     The investigators anticipate that utilization of retapamulin preoperatively will eliminate~     MRSA colonization among patients who are colonized in their nares.~   "
203095|NCT00903903|"~     The purpose of this study is to compare the data obtained by computer-aided quantification of~     the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional~     power Doppler ultrasonography and the clinical data used to represent the degree of joint~     inflammation. Intra- and inter-observer reliability of this method will also be determined.~   "
203096|NCT00903890|"~     This study is to inquire by mailed survey regarding the cardiac and general health of~     patients previously treated for Hodgkin's and non-Hodgkin's lymphoma with radiation~     therapy/anthracycline chemotherapy.~   "
203097|NCT00903877|"~     Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia.~     Determine the feasibility and promise of an appropriately powered future prospective~     randomized controlled study of using T3 (the active form of thyroid hormone) for the~     treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and~     promise of conducting a prospective controlled study in the future.~   "
203098|NCT00903864|"~     The purpose of this study is to monitor the blood pressure level of the patient using a cuff~     ranged 22 cm-30 cm.~   "
203099|NCT00903851|"~     Patients with Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy~     with dynamic allodynia of the lower extremities, patients with Type I or II diabetes and pain~     distal symmetric sensorimotor polyneuropathy with no dynamic allodynia of the lower~     extremities, or patients with idiopathic distal predominantly sensory neuropathy participated~     in a Phase IV clinical trial to assess the efficacy of lidocaine patches in treating painful~     diabetic neuropathy or idiopathic distal sensory neuropathy.~   "
203100|NCT00903838|"~     This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study~     of pardoprunox as adjunctive treatment to levodopa.~   "
203101|NCT00903825|"~     The aim of this study is to evaluate the optimization of local anesthetic effect with duplex~     ultrasound-guided injection of lidocaine before femoral artery puncture during diagnostic or~     therapeutic interventional procedures.~      In total, 200 patients scheduled for various diagnostic or therapeutic interventional~     radiology procedures requiring femoral artery puncture, will be randomized in two groups~     after informed consent. Patients will be randomized to undergo groin local anesthesia with~     the proposed method of duplex ultrasound guided injection of lidocaine versus standard~     injection of lidocaine with manual palpation (control group).~      The protocol includes the registration of patients' demographics (age, gender, risk factors~     for peripheral arterial disease), arterial morphological characteristics (calcifications and~     presence of atheromatous disease), as well as technical details of the procedure (total~     puncture duration, sheath size, antegrade/retrograde puncture, etc.)~      Primary study endpoint will be peri-procedural pain that will be assessed with the use of a~     visual analog scale (VAS) completed by the patient at the end of the procedure. Secondary~     study endpoints will evaluate procedural safety and complications during the immediate~     post-procedural period (up to 7 days).~   "
203102|NCT00903812|"~     This is multi-center, international observational study of subjects receiving CHOP-14 or~     CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites~     will contribute information on subjects treated at their institution.~   "
203103|NCT00903799|"~     The aim of this clinical trial is to assess the symptomatic efficacy and the impact on the~     utilization of healthcare resources of a treatment by gastric electrical stimulation (ENTERRA~     ®) in patients with refractory nausea and/or vomiting leading to a nutritional impairment.~     Eligible patients will be those with refractory symptoms either idiopathic, postsurgical or~     due to diabetes mellitus. The duration of the study will be 28 months for each patient.~      After a run-in period of 4 months during which a prospective assessment of healthcare~     resources utilization and of the severity of the symptoms will be obtained, patients will be~     implanted. The follow-up period after implantation of the device will last 24 months in every~     patients and will be divided in two parts: a) After the first postoperative month during~     which the device will remained on the OFF position, the first phase of the study will be a~     randomized double-blind cross-over study with 2 periods of 4 months during which the device~     will be activated or not. After the 9th month of follow up, the trial will be an open trial~     and the device will be activated in all patients.~      During the whole trial, patients will record all types of healthcare resources utilizations~     (hospitalizations, drug treatments, endoscopic procedures…) while the symptomatic efficacy of~     the treatment will be assessed by standard questionnaires at the following visits scheduled~     at 1, 5, 9, 12, 18, 24 months. The glycemic control will be determined at each visit in~     diabetic patients. A delayed gastric emptying will not be a selection criteria but we have~     planned to analyze the clinical results of the treatment in taking into account a delayed or~     normal gastric emptying during the pre-implantation period. Moreover, gastric emptying~     studies have been scheduled at 5, 9, 12 and 24 months to test the impact of gastric~     electrical stimulation on gastric emptying.~   "
203104|NCT00903786|"~     The purpose of this trial is to investigate the safety and tolerability of perampanel in~     long- term treatment in the patients with refractory partial epilepsy (uncontrolled with~     other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.~   "
203105|NCT00903773|"~     The purpose of this study is to investigate the effect of severe renal impairment or failure~     on the single-dose pharmacokinetics of telaprevir (TVR). Pharmacokinetics means how the drug~     is absorbed into the bloodstream, distributed in the body and eliminated from the body. In~     addition, the effect of severe renal impairment on the total and unbound plasma~     concentrations of the sum of TVR and its R-diastereomer VRT-127394 will be assessed.~     (Diastereomers are substances whose chemical structures are mirror images of each other).~     Finally, the short-term safety and tolerability of TVR in participants with severe kidney~     disease will be determined. The results of this study will guide dose recommendations for TVR~     in subjects with kidney disease.~   "
203106|NCT00903760|"~     The goal of this clinical research study is to learn if sequential administration of~     decitabine and clofarabine can help to control MDS better than decitabine alone. The safety~     of this drug combination will also be studied.~   "
203107|NCT00903747|"~     This is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised~     study, stratified by gender and with a hybrid crossover group design, to compare treatment~     with prucalopride 2 mg/day (intended therapeutic dose) and prucalopride 10 mg/day~     (supratherapeutic dose) with placebo. A single oral dose of 400 mg moxifloxacin is included~     as a positive control in terms of the effect on cardiac repolarisation.~      Study hypothesis:~      Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in~     healthy male and female volunteers will not increase QTc interval compared to placebo.~   "
203182|NCT00902707|"~     The purpose of this research study is to test the ability of Mucinex, an oral,~     over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles~     from the subject's lungs (called mucociliary clearance). The study will also monitor the~     metabolism of the drug by the subject's body.~   "
211477|NCT00792402|"~     Objective: To assess the effectiveness of implementation process of an electronic Heart~     Failure guideline in primary care in the city of Barcelona.~   "
203108|NCT00903734|"~     The goal of this screening portion of this clinical research study is to learn if you are~     eligible to take part in a clinical research study using Tarceva (erlotinib hydrochloride)~     and either Erbitux (cetuximab), Velcade (bortezomib), or Sprycel (dasatinib).~      If the results of the screening portion of this clinical research study show that you are~     eligible to take part in one of the studies described above, the study drug that you will be~     assigned to take will depend on the results of biomarker analysis performed as a part of the~     screening tests described below. Biomarkers are chemical markers in the blood/tissue that~     may be related to how your body might react to the study drug.~   "
203109|NCT00903721|"~     The investigation will be conducted to define safety and efficacy under the conditions of~     post-marketing use of this drug in subjects with allergic rhinitis.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
203110|NCT00903708|"~     Primary Objective:~        -  To determine a recommended Phase 2 dose of LY2275796 that may be safely administered to~          patients with advanced cancer, with prospects for therapeutic biologic effects. This~          will require simultaneous:~        -  monitoring of toxicities & determination of maximal tolerated dose (MTD)~        -  detecting eIF-4E target inhibition in tumor~        -  pharmacokinetic measurements~      Secondary Objectives:~        -  To estimate pharmacokinetic parameters of LY2275796 and explore~          pharmacokinetic/pharmacodynamic relationships~        -  To document any antitumor activity observed with LY2275796~   "
203111|NCT00903695|"~     A vitamin nutriceutical, Memory XL, has been shown to provide maintenance of cognitive status~     in mild, moderate, and severe Alzheimer's disease patients (2 publications by T. Shea).~     Because this nutriceutical is now patented by the Univ. of Mass., other trials at that~     institution may be considered a conflict of interest. Therefore, a study of its effects on~     Mild Cognitive Impairment (MCI) patients will be conducted by PI who is not affiliated with~     Univ. of Mass. or with Dr. Shea. The study hypothesis is: Memory XL will maintain or improve~     the cognitive and behavioral status of patients diagnosed with MCI during the year of~     participation in the study; normally, 10-25% of MCI patients convert to mild Alzheimer's~     dementia each year.~   "
203112|NCT00903682|"~     The purpose of this study is to compare the neuropsychiatric adverse event profiles of~     etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2~     N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability~     and efficacy of both treatment arms will be assessed throughout the study.~   "
203113|NCT00903669|"~     The current study sought to determine the reliability of the rehabilitation protocol using~     the labial commissure angle (LCA) as an indicator of both muscle tonus and therapeutic~     success. The investigators hypothesized that this measurement would provide objective data~     regarding the efficacy of rehabilitation for these challenging patients.~   "
203114|NCT00903656|"~     The aim of this study is to evaluate the potential of a Lapatinib plus Caelyx combination~     therapy as an effective and safe therapeutic regimen with a favourable cardiotoxicity~     profile, in the treatment of metastatic breast cancer following failure of prior trastuzumab.~   "
203115|NCT00903643|"~     The purpose of this study is to determine if clinically relevant subsets exist in patients~     meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential~     responses to treatments and if verified, this will be important for the stratification of~     patients in clinical studies related to PBS.~   "
203116|NCT00903630|"~     RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor.~     Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving lenalidomide together with doxorubicin hydrochloride liposome may kill more~     tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide~     when given together with doxorubicin hydrochloride liposome in treating patients with~     recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.~   "
203117|NCT00903617|"~     This is a two part study (Part A and Part B) that will first aim to establish the PK/PD~     relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm~     the effect using the most relevant dose(s) (Part B: ~90 subjects). Doses of 5mg, 50mg and~     150mg of GSK256073 will be administered in Part A, and the dose(s) for Part B will be based~     on the PK/PD data from Part A. Data from Part A and Part B will be combined to decrease~     overall subject numbers needed in part B. Part B of the study will include a niaspan arm for~     relative comparison of the effects of GSK256073 and niacin on lipids and flushing~   "
203118|NCT00903604|"~     The purpose of the present research study is to investigate the pharmacokinetics, as well as~     safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in~     patients undergoing cardiac surgery. AP214, the investigational drug, is being developed to~     potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.~   "
203119|NCT00903591|"~     This study is being done to find out what factors may be related to the risk of getting a~     second breast cancer among women who already have breast cancer in one breast. It will look~     at how genes, treatment for breast cancer; including radiation therapy, and the effects of~     different lifestyle activities, may affect the risk of breast cancer. It will use different~     processes to find genes that might increase the risk of breast cancer. The results of this~     study may help to develop better ways to detect, treat and prevent breast cancer. This study~     will compare women who have breast cancer in both breasts to women who have breast cancer in~     only one breast.~   "
203120|NCT00903578|"~     The present study will examine whether serum FGF-23 and serum phosphate at baseline of kidney~     transplant recipients can predict progression of allograft dysfunction at 3 years and~     all-cause mortality at 5 years.~   "
203183|NCT00902694|"~     This study will determine whether a behavioral weight loss intervention including dietary~     counseling and exercise is effective in helping people with serious mental illnesses lose~     weight.~   "
203184|NCT00902681|"~     This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended~     releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.~   "
212875|NCT00773734|"~     The purpose of this study was to test if the drug apremilast was safe, if it helped improve~     psoriasis, and how well the participants tolerated it.~   "
203121|NCT00903565|"~     The aim of this study is to enroll 785 eligible stage II colon cancer patients in order to~     validate the performance of ColoPrint in estimating 3-year relapse rate.~      Secondary objectives include comparing the objective risk assessment results from the~     prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as~     well as the Investigator's independent assessment. As this is the first prospective study of~     ColoPrint, this study will also address the logistics and quality assurance of using~     ColoPrint in clinical practice.~      Patient treatment is at the discretion of the physician, adhering to National Comprehensive~     Cancer Network (NCCN)-approved regimens or a recognized alternative.~      The enrollment period will be 6 years. It is expected that 1800 to 2400 patients will be~     enrolled in order to obtain 785 analysable stage II samples from eligible patients.~     Approximately 25-35 clinical sites will be involved worldwide.~      The statistical analysis will be performed by Agendia and an independent research institute~     or hospital.~      Study Design Extension Study:~      This will be a prospective study to measure the impact of ColoPrint on adjuvant treatment in~     stage 2 colorectal cancer patients. After surgery the tumor sample will be shipped in RNA~     Retain to Agendia. The online Clinical Report Form (CRF) 0 will be completed to document if~     the patient fulfils the inclusion criteria. Baseline clinical data and the patient and~     physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict~     without knowing the ColoPrint result will be entered in CRF 1. After completion of CRF1 the~     ColoPrint result is released. CRF2 will be completed after the final treatment decision has~     been made.~      This CRF will capture the patient and physician chemotherapy intention, patient's perceived~     recurrence risk and decisional conflict, impact of ColoPrint and the actual treatment the~     patient will receive. CRF3 will be completed 12 months after enrolment and will capture the~     patient status, patient's perceived recurrence risk and decisional conflict. CRF4 and 5 will~     be completed 3 and 5 years after surgery and will capture the patient status. A sample size~     of 210 stage 2 colon cancer patients is required to detect a 10% overall treatment change (5%~     significance and 90% power).~      Reporting of the Results:~      Blinded Study; The ColoPrint results will not be reported to the physician and/or patient at~     the time of enrolment. All samples will be stored in a freezer until 550-575 eligible stage~     II patients have been enrolled. Samples will then be analyzed in one batch in a blinded~     fashion from the clinical results.~      Extension Study; The ColoPrint results will be reported to the physician and patient after~     CRF1 has been completed.~   "
203122|NCT00903552|"~     This is a phase 2A randomized, double blind, placebo controlled trial to evaluate the safety~     and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine~     (recombinant) in healthy adults.~   "
203123|NCT00903539|"~     To prospectively monitor the safety and performance of the catheter securement device in~     subjects whose catheter is secured with the Interrad Medical SecureAcath device.~   "
203124|NCT00903526|"~     During the past two decades, the frequency of invasive fungal infections has increased~     dramatically in hospitalised patients throughout the world, and Candida has now emerged as~     one of the leading causes of bloodstream infections (BSIs). Risk-factors for invasive~     candidiasis include improvements in intensive care strategies (i.e., central venous~     catheters, mechanical ventilation, hyper-alimentation), prolonged stays in intensive care~     units (ICUs), the development of more aggressive surgical techniques, and the prolongation of~     survival of critically-ill patients. Two other important factors, observed mainly in cancer~     patients, are colonization of mucous membranes by yeasts, and neutropenia, resulting from~     increased use of antibiotics and anti-neoplastic agents, respectively. The crude mortality~     rate of candidaemia is high (38-75%), and the attributable mortality has been estimated at~     25-38%. During the past 15 years, the prevalence of infections caused by non-albicans Candida~     spp. has increased exponentially, so that these organisms now account for > 50% of episodes~     of fungaemia in various surveys. The increase in invasive fungal infections, the associated~     high mortality rate, and the emergence of antifungal resistance, have all driven the search~     for more potent antifungal drugs. The aims of the present study are to investigate the~     prevalence and the epidemiology of candidaemia and to determine the antifungal susceptibility~     patterns of Candida spp. isolates from a tertiary-care hospital in Italy.~   "
203125|NCT00903500|"~     The intervention consists of an individual counseling session, telephone counseling (7~     calls), given by a psychologist, and a pedometer. The intervention is based on cognitive~     behavioral therapy, the Diabetes Prevention Program, the first Step Program and Motivational~     Interviewing. The taxonomy of behavior change techniques is also taken into account. The~     duration of the intervention is six months. The individual session takes place one week after~     the baseline measurements, together with the participants' follow-up appointment with their~     endocrinologist. The individual session takes place at the endocrinology department and is~     expected to last approximately 30 minutes. In addition to the session, the participants of~     the intervention group receive a pedometer and a pedometer diary for six months. Participants~     of the intervention group also receive telephone counseling from the psychologist during 24~     weeks. They receive a call every two weeks for four weeks and then every four weeks for the~     next 20 weeks, good for a total of seven counseling calls. The calls are expected to last~     approximately 20 minutes. The Control Group has no intervention at all and receive their~     usual care.~   "
203126|NCT00903474|"~     RATIONALE: Mindful movement is a self-directed activity of mindfulness (intention, attention,~     and attitude) and physical movement. A mindful movement program may be effective in improving~     well-being in older women who are breast cancer survivors.~      PURPOSE: This randomized clinical trial is studying how well a mindful movement program works~     in improving quality of life in older female breast cancer survivors.~   "
203127|NCT00903461|"~     The Epidermal Growth Factor Receptor (EGFR) is highly expressed in SCCHN and its~     overexpression is associated with poor patient outcome. EGFR is a promising target of~     anticancer therapy. We have developed EGFR antisense DNA as a safe and potentially~     efficacious treatment for SCCHN as shown in a previous phase I study conducted at the~     University of Pittsburgh. Cetuximab (Erbitux or C225) is a chimerized EGFR monoclonal~     antibody that has produced positive results in a phase III trial in SCCHN when added to~     radiation therapy and was approved by the FDA for the treatment of locally advanced SCCHN.~     Radiation plus cetuximab is considered a standard treatment, especially for patients who are~     not good candidates for chemotherapy. In the current study, we plan to evaluate the addition~     of intratumoral EGFR antisense DNA (EGFR AS) to standard radiation with concurrent cetuximab~     in patients.~   "
203128|NCT00903448|"~     The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid~     suppression.~   "
203129|NCT00903435|"~     The purpose of this study is to determine whether more than one subpopulation exists of~     patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to~     determine if subjects with IC have normal counterirritation-related modulatory systems.~   "
203185|NCT00902668|"~     RATIONALE: Drugs, such as lovastatin, may protect normal cells from the side effects of~     radiation therapy.~      PURPOSE: This phase II trial is studying how well lovastatin works in reducing side effects~     after radiation therapy in women with breast cancer.~   "
203212|NCT00902317|"~     The purpose of this study is to compare the different endovascular treatment modalities for~     the femoropopliteal segment, and to determine technical success, efficacy and patency at~     mid-term follow-up. Modalities include; Angioplasty/stent (Control group, Guidant),~     Cryoplasty/stent (Boston Scientific), Laser Angioplasty/stent (Spectranetics), SilverHawk~     Atherectomy/stent (Fox Hollow), and Viabahn Endograft (WL Gore).~   "
203130|NCT00903422|"~     This study will evaluate the safety and tolerability of eltrombopag in the treatment of low~     platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary~     acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or~     ineligible to receive azacitidine, decitabine, intensive chemotherapy or~     autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which~     patients will receive study medication daily for 6 months, during which time the dose of~     study medication may be adjusted based upon individual platelet counts and bone marrow blast~     counts. All subjects will receive best standard of care (platelet transfusions, mild~     chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition~     to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag~     treatment if a clinically and statistically significant improvement in bone marrow blast~     counts is seen in subjects treated with eltrombopag.~   "
203131|NCT00903409|"~     In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4~     g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with~     simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This~     extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza®~     (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin~     plus placebo to simvastatin plus Lovaza® for lowering non-High Density~     Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at~     12 and 24 months.~   "
203132|NCT00903396|"~     RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation~     therapy. It is not yet known whether palonosetron hydrochloride is more effective than a~     placebo in preventing nausea and vomiting.~      PURPOSE: This randomized phase II trial is studying the side effects of palonosetron~     hydrochloride and to see how well it works in preventing nausea and vomiting caused by~     radiation therapy in patients with primary abdominal cancer.~   "
203133|NCT00903383|"~     The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305~     versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate~     therapy.~   "
203134|NCT00903370|"~     The purpose of the research is to determine whether treating atrial fibrillation with~     surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery~     by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a~     technique used by surgeons to deaden atrial heart tissue and block electrical signals that~     may be causing your heart to beat irregularly. There are no new procedures being tested in~     this study; both mitral valve surgery and surgical ablation are used regularly in patients~     who have mitral valve problems and atrial fibrillation, although no surgical ablation devices~     have been approved by the Food and Drug Administration for the treatment of atrial~     fibrillation. What is not known with certainty, is whether patients with atrial fibrillation~     who are having planned mitral valve surgery would do better if they also had surgical~     ablation rather than medication alone to treat their atrial fibrillation.~   "
203135|NCT00903357|"~     The purpose of this study is to assess the clinical effectiveness of Montelukast in children~     (2~6 years old) with atopic dermatitis and identify the pathophysiologic background of~     Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4~     (LTE4) and Eosinophil protein X(EDN).~   "
203136|NCT00903344|"~     Studies have shown that lactation is associated with a loss of bone density from four to~     seven percent at the spine and hip among women who lactate for six months. Decline in bone~     density with lactation occurs rapidly. Although bone density increases after weaning, there~     is controversy on whether or not it is completely restored. Epidemiological studies find no~     significant negative impact of lactation on bone mass or fractures, and in fact there is~     evidence that lactation has a positive effect on bone mass. We think that interventions that~     attenuate this physiologic loss of bone that is associated with lactation and accelerate~     restoration of bone mass after weaning may result in improved long term bone mass and~     diminished fracture risk.~   "
203137|NCT00903331|"~     The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan)~     10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study~     objective is to demonstrate that macitentan positively affects the forced vital capacity~     (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF).~      The secondary objectives are to evaluate the effect of macitentan on the time to disease~     worsening or death in patients with IPF, and to evaluate the benefit/risk profile of~     macitentan in the treatment of patients with IPF.~   "
203138|NCT00903318|"~     Objective 1: To assess environmental exposure to chemicals/toxins, including phthalates,~     among rural and urban Mexican American men and women (n=300), aged 18 to 40, in urban~     Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico~     border region via survey.~      Objective 2: To determine generational sex ratio trends in urban Baytown, TX and along the~     rural Rio Grande Valley (Hidalgo County) utilizing vital statistics data from the Texas~     Department of Health and the Center for Health Statistics.~      Objective 3: To measure urinary phthalate levels and self-reported phthalate exposure in~     Mexican American men and women from urban Baytown, Texas and rural communities along the~     lower Rio Grande Valley (Hidalgo County) on theTexas-Mexico border. To conduct an optional~     procedure, chromosomal sex determination, among a subgroup of 50 persons (13 men + 12 women~     in each community) from participants who complete the survey in Objective 1.~   "
203139|NCT00903305|"~     RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective~     than standard care in treating patients with breast cancer.~      PURPOSE: This clinical trial is studying nurse-provided care to see how well it works~     compared with standard care in treating patients with stage I, stage II, or stage III breast~     cancer.~   "
203140|NCT00903292|"~     Currently the investigators have two different classes of second-line treatment options in~     recurrent non-small Cell Lung Cancer (NSCLC). In chemotherapy, docetaxel and pemetrexed~     produced similar treatment efficacy outcomes, while pemetrexed had a better tolerability. In~     recent analysis of pemetrexed clinical studies, a strong treatment-by-histology interaction~     in overall survival and progression free survival that indicated better efficacy for~     non-squamous patients treated with pemetrexed. These data supports that pemetrexed could be a~     preferable chemotherapy drug especially in adenocarcinoma NSCLC patients.~   "
203142|NCT00903266|"~     We are doing this clinical trial in order to evaluate two different treatments for non-fluent~     aphasia: Melodic Intonation Therapy (MIT) and Speech Repetition Therapy (SRT). MIT uses a~     simple form of singing, while SRT uses intensive repetition of a set of words and phrases. We~     want to see which intensive form of treatment is more effective in leading to an improvement~     in speech output compared to a no-therapy control period, and whether either treatment can~     cause changes in brain activity during speaking and changes in brain structure. We will use a~     technique known as functional Magnetic Resonance Imaging (fMRI) to measure blood flow changes~     in the brain and structural MRI that assess brain anatomy and connections between brain~     regions. We will use fMRI to assess brain activity while a patient speaks, sings, and hums.~     We will assess changes in brain activity and in brain structure by comparing scans done prior~     to treatment to scans obtained after treatment and we will also examine changes between~     treatment groups. We will correlate changes in brain activity and brain structure with~     changes in language test scores.~   "
203143|NCT00903253|"~     The objective of this study is to evaluate the single-dose plasma pharmacokinetics of LNK-754~     as well as safety and tolerability in normal healthy male and female elderly volunteers~   "
203144|NCT00903240|"~     The purpose of this study is to detect recurrent bladder cancer using a combination of~     protein and DNA biomarkers in urine~   "
203145|NCT00903227|"~     Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway~     inflammation with topical steroids improves the twitchiness of the airways~     (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces~     symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related~     deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves~     quality of life. While there is evidence that combined treatment of the nose and the lungs~     with topical steroids improves symptoms and underlying inflammation, it is unclear whether~     such control can be achieved using a smaller dose of inhaled steroid in combination with~     nasal steroid. It is therefore the intention of this study to evaluate if combination steroid~     therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis~     using sensitive markers of airway inflammation.~   "
203146|NCT00903214|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors identify biomarkers related to cancer. Riluzole may help slow the~     growth of tumor cells.~      PURPOSE: This phase I trial is studying riluzole in women with stage I, stage II, or stage~     IIIA breast cancer.~   "
203147|NCT00903201|"~     The purpose of this study is to determine whether the safety, tolerability and~     pharmacodynamics of SB656933 in patients that have cystic fibrosis~   "
203148|NCT00903188|"~     This study intends to determine whether steroid withdrawal or calcineurin inhibitor~     withdrawal is superior for graft function and graft survival. Secondary endpoints for this~     study are: incidence of tumors and cardiovascular events.~      The primary objective: To assess if superior graft function (glomerular filtration rate (GFR)~     difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de~     novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to~     Myfortic-cyclosporine.~   "
203149|NCT00903175|"~     This study assessed the efficacy and safety of first-line RAD001 followed by second-line~     sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001~     for the treatment of patients with MRCC.~   "
203150|NCT00903162|"~     The purpose of this study is to determine the safety and tolerability of the combination of~     two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least~     4.5 years. Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen),~     is a drug that is FDA approved. It has been shown to reduce the risk of breast cancer~     recurrence in postmenopausal women with breast cancer who have been previously treated with~     tamoxifen. Letrozole works by stopping the production of estrogen in parts of the body other~     than the ovaries. Leuprolide is a drug that stops a women's ovarian cycles. This process is~     known as ovarian function suppression. Stopping a women's menstrual cycle may be effective~     against breast cancer for some patients when given as initial therapy. The combination of~     letrozole and leuprolide is considered a standard treatment for women with metastatic breast~     cancer, and is also sometimes used for treatment of premenopausal early stage breast cancer,~     but it has not been accepted as a standard of care treatment.~   "
203151|NCT00903149|"~     The purpose of this study is to investigate if a cost and time effective intervention in a~     previous RCT for preterm infants and their parents can reduce the parents experience of~     concern and stress, and improve the childrens development in various aspects at three years~     of corrected age.~      Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have~     a higher developmental level then preterm children of parents who received the usual~     treatment.~      Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of~     stress and concern then parents who received treatment as usual.~   "
203152|NCT00903136|"~     RATIONALE: A tethered capsule endoscope may be as effective as standard sedated endoscopy of~     the esophagus, stomach, and duodenum in screening for Barrett esophagus.~      PURPOSE: This phase I/II trial is studying how well a tethered capsule endoscope works in~     screening participants for Barrett esophagus.~   "
203153|NCT00903110|"~     The Eu-IGFD is a descriptive, multicenter, observational, prospective, open-ended, non~     interventional, post-authorisation surveillance registry. The purpose of this study is to~     collect long-term safety information on the use of recombinant DNA-derived human Insulin-like~     Growth Factor-1 (rhIGF-I) Increlex® replacement therapy for the treatment of children with~     growth failure.~   "
203154|NCT00903084|"~     This study will determine whether a hair test can reveal how much of the anti-HIV medication~     tenofovir a person without HIV has been exposed to.~   "
203198|NCT00902499|"~     The purpose of this study is to begin the process of validating fMRI (functional magnetic~     resonance imaging) as a biomarker for use in clinical trials and longitudinal studies of~     clinical progression in mild cognitive impairment (MCI) and Alzheimer's disease (AD).~   "
203213|NCT00902304|"~     This study will assess the efficacy of an intensive blood pressure management strategy~     compared to usual care in a primary care (general practice) setting.~   "
203214|NCT00902291|"~     A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in~     subjects with Metastatic Pancreatic Cancer.~   "
203155|NCT00903071|"~     In this project the investigators implement and test the ability of a Personalized Physician~     Learning (PPL) intervention to improve hypertension (HT) care with the following specific~     aims:~      Specific Aim 1: Implement two versions of a Personalized Physician Learning (PPL)~     intervention and assess the ability of these interventions to improve hypertension control in~     primary care practice.~        -  Hypothesis 1: Patients of physicians who receive the REAL+PPL Intervention (Group 1)~          will subsequently have better HT control compared to patients of control group~          physicians (Group 3).~        -  Hypothesis 2: Patients of physicians who receive the SIM+PPL Intervention (Group 2) will~          subsequently have better HT control compared to patients of control group physicians~          (Group 3).~        -  Hypothesis 3: Patients of physicians who receive the REAL+PPL (Group 1) will~          subsequently have better HT control compared to patients of physicians who receive the~          SIM+PPL (Group 2).~      Specific Aim 2: Assess the cost-effectiveness of the SIM+PPL and REAL+PPL interventions,~     relative to no intervention.~   "
203156|NCT00903045|"~     Overactive bladder (OAB) is defined as urgency, with or without urge incontinence, usually~     with frequency and nocturia in the absence of local pathological or endocrine factors.~     Urgency is defined as the complaint of a sudden compelling desire to pass urine that is~     difficult to defer and an abnormal sensation that is distinctly different from the normal~     physiologic feeling of 'urge to void' that occurs during typical bladder-filling cycles.~      Because up to 50% of patients with OAB experience urgency without incontinence, and because~     urgency is the most bothersome symptom that drives behavioral adaptations such as frequent~     voiding because of the very fear of urgency, this is the cornerstone symptom of OAB that~     indicates the diagnosis of OAB.~      Even though any effective treatment for OAB must reduce the patient's sense of urgency, its~     subjective nature makes it difficult to measure. Therefore, the clinical efficacy of OAB~     treatment was traditionally measured in terms of objective surrogate parameters instead of~     urgency itself: for example, change in urinary frequency, incontinent episodes, number of~     pads and urodynamically proven detrusor overactivity, which could be measured easily and~     quantifiably.~      Recently, several methods that measure urgency have been developed and used in clinical~     practice. However, the analysis questioned the clinical significance of the results; a~     possible reason for this being the lack of data based on urinary urgency and the use of~     sensitive patient-driven criteria.~      Propiverine hydrochloride (1-methyl-4-piperidyl diphenylpropoxyacetate hydrochloride) is a~     drug with combined antimuscarinic and calcium antagonistic actions. Previous trials on the~     clinical efficacy and safety of propiverine for treating patients with OAB have reported~     improvements in urinary frequency and incontinence, but not in urgency.~      The aim of this study was to explore the efficacy of a daily regimen of propiverine at 20 mg~     (immediate release formulation) in improving urgency from baseline to 12 weeks of treatment~     in patients with OAB.~   "
203157|NCT00903032|"~     We propose to test the effectiveness of a multi-faceted patient-centered adherence~     intervention among veterans following ACS hospitalization to improve adherence to~     cardioprotective medications (primary aim). Secondary aims will assess whether the~     intervention improves achievement of secondary prevention blood pressure (BP) and low density~     lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI~     hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.~      ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to~     cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by~     helping veterans take their medications routinely as prescribed, the quality of~     cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been~     associated with improved outcomes, and the efficiency of care by using telephone calls and~     tele-monitoring for communication with patients rather than clinic visits. The findings of~     the study will address an important gap in knowledge (i.e., how to improve adherence to~     medications following ACS discharge) and will be generalizable to other VA Medical Centers~     and veterans.~   "
203158|NCT00903019|"~     This study will test the feasibility and effectiveness of therapy given via teleconferencing~     to depressed homebound older adults.~   "
203159|NCT00903006|"~     The goals of this clinical research study are to learn the tolerable and effective doses of~     the drug MK-0646 that can be given in combination with Sprycel (dasatinib) and Faslodex~     (fulvestrant) to patients with hormone receptor-positive metastatic breast cancer. The safety~     of these drugs will be studied as well as markers in the tumors that may help researchers~     predict the tumors' reaction to the treatment.~   "
203160|NCT00902993|"~     This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects~     when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6~     multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.~   "
203161|NCT00902980|"~     This is a multicentre, observational, non-interventional, retrospective analysis by chart~     review.~   "
203162|NCT00902967|"~     The study is planned to check the analgesic and anti-inflammatory properties of Atorvastatin~     in patients who will be undergoing abdominal surgery under spinal anesthesia. The~     investigators intend to monitor the analgesic requirements, the rate of wound healing and the~     inflammatory markers in this trial.~   "
203163|NCT00902954|"~     The purpose of this study is to compare the rate of disease free survival (DFS) and distant~     disease free survival (DDFS) at 5 years in postmenopausal women with hormone receptor and~     lymph node positive breast cancer randomized between anastrozole/letrozole 5 years and~     anastrozole/letrozole 2-3 years switching to exemestane 3-2 years.~   "
203164|NCT00902941|"~     There is convincing evidence from numerous studies using both psychophysical and~     electrophysiological approaches that olfaction is markedly reduced in Parkinson´s disease~     (PD). Data on the prevalence of olfactory dysfunction in PD however, range from 45% and 49%~     in the pioneering studies of Ansari & Johnson, and Ward, respectively, up to 74% in the work~     of Hawkes et al., or as high as 90% in a study published by Doty et al. Quality of life,~     safety, and interpersonal relations, as well as food behavior/nutritional intake are severely~     altered in a large proportion of patients with olfactory loss. Thus, the same can be assumed~     in patients with Parkinson's disease. If it was possible to improve olfactory function this~     would appear as a significant effect in patients with Parkinson's disease. Provided the study~     would reveal an improvement of olfactory function following therapy with rasagiline, this~     would have tremendous worldwide impact on the use of this drug. Considering the frequency of~     PD a very large number of patients would benefit from these findings, especially in terms of~     quality of life.~   "
203165|NCT00902928|"~     The purpose of this study is to evaluate the efficacy and safety of various doses of YM150~     (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in~     patients that are undergoing elective hip replacement surgery.~   "
203166|NCT00902915|"~     The purpose of this study is to determine efficacy of lenalidomide and dexamethasone in the~     treatment of patients with acute Myeloma (light chain)-induced renal failure.~   "
203167|NCT00902902|"~     The aims of this study were divided into three parts:~        1. To evaluate the sensitivity and specificity of GP73 for the diagnosis of hepatitis B~          related HCC. Established the standard of GP73 in normal people.~        2. To definitude the connections between the GP73 level and various diseases.~        3. To find the relations of HCC metastasis and recurrence.~      Study design:~        1. Collectivity type: Prospective，randomized, controlled, multi-central clinical study.~        2. Patients: The subjects were from different hospitals including: Peking Union Medical~          College Hospital (PUMCH), The Cancer Hospital of Peking Union Medical College (PUMC),~          QiDong Cancer Institute, and Department of Surgery University of Chicago from November~          of 2007 till the end of this study.~      Study arrangement:~      This study was consisted of three parts:~        1. Established the standard of normal people and test the sensitivity and specificity of~          HCC patients. The samples were acquired from Health Screen Center and Department of~          liver surgery of PUMCH, The Cancer Hospital of PUMC and QiDong Cancer Institute.~        2. Extend the study bound, including the hepatitis B virus (HBV) and hepatitis C virus~          (HCV) carriers. The HBV (+) samples were come from Chinese hospitals and institutions.~          The HCV (+) samples were provide by the Department of Surgery University of Chicago.~        3. Research the relations of serum GP73 level and the other diseases, such as other~          malignant liver tumors, liver metastatic tumors, liver benign tumor, HCC recurrence~          following surgery etc.~   "
203168|NCT00902889|"~     This is a single centre, controlled phase I study, which evaluates safety and efficacy of~     stimulation of lower caudal two contacts (GPI) vs. upper cranial two contacts (GPE) in~     Huntington´s disease (HD).~   "
203169|NCT00902876|"~     The purpose of this multi-center study is to determine the efficacy and safety of Mucograft®~     in combination with the coronally advanced flap (CAF) for the treatment of gingival~     recessions. It is assumed that the CAF combined with Mucograft® will result in improved~     outcome in terms percentage of root coverage and soft tissue thickness in comparison to CAF~     alone (control).~   "
203170|NCT00902863|"~     This project seeks to measure the effectiveness of a course in self-management strategies~     (including yoga, mindfulness, and breathing exercises). The course will be provided by a~     certified yoga instructor to patients being followed at the Pain Management Centre, Hamilton~     Health Sciences (HHS).~   "
203171|NCT00902850|"~     The objective of this one-day study will be to evaluate the clinical performance of SofLens~     Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.~   "
203172|NCT00902837|"~     The primary objectives are~        -  to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment~          with OxyPR with regards to analgesic efficacy and locomotor function.~        -  to demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone~          prolonged release tablets have improvement in symptoms of constipation compared to~          subjects taking oxycodone prolonged release tablets alone~   "
203173|NCT00902824|"~     This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated~     immune (CTL) responses.~   "
203174|NCT00902811|"~     Antimalarial drug resistance is increasing nearly everywhere in the tropical world,~     confounding global attempts to Roll Back Malaria. South East Asia has the most resistant~     malaria parasites in the world. This has limited the options for treatment in this region.~      Artemisinin-based combination therapy is now the recommended treatment for uncomplicated~     falciparum malaria. The success of this policy change in practice will depend on the efficacy~     of the components of the combination used, the population coverage achieved, high levels of~     adherence to treatment, low cost of the drugs, and preferably the drugs in a combination~     treatment should be formulated in a single tablet, to prevent one drug being taken without~     the partner drug. Until recently there were only two artemisinin-based fixed combinations~     available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former~     has international registration. More fixed combinations are needed urgently.~   "
203175|NCT00902798|"~     This study will investigate and contrast the effects of two psychological treatments for~     adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive~     remediation intervention that aims to help adults with problems in thinking, planning, and~     socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that~     aims to help adults learn about their condition, manage their emotions and stress, improve~     their social skills, and cope with everyday problems.~   "
203176|NCT00902785|"~     Identify early markers of choroidal neovascularization (CNV) in the fellow eye of a patient~     with CNV in the other eye due to age-related macular degeneration with the expectation of~     being able to identify patients in need of intervention.~   "
203177|NCT00902772|"~     The purpose of this study is to examine the abuse potential of AZD7325.~   "
203178|NCT00902759|"~     The purpose of this pilot study is to determine the effects of a walking program on fatigue,~     physical functioning and QOL in patients with pancreatic and periampullary cancers who have~     had surgery or are undergoing adjuvant therapy with chemotherapy (CT) and/or radiation~     therapy (RT). This pilot study will utilize the walking program developed by Mock et al.~     (2001), in their investigation of the improvement of fatigue and QOL in breast care patients~     following surgery who were receiving CT, RT or biotherapy. No studies published to date have~     utilized a progressive walking program in post-operative pancreas and ampullary cancers to~     determine if it reduces adverse effects, such as fatigue or improves functionality and QOL~     scores.~   "
203179|NCT00902746|"~     The purpose of this long-term study is to determine whether NPC-01 is effective in the~     treatment of dysmenorrhea associated with endometriosis.~   "
203180|NCT00902733|"~     RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective~     than standard care in treating patients with pancreatic cancer.~      PURPOSE: This clinical trial is studying nurse-provided care to see how well it works~     compared with standard care in treating patients with pancreatic cancer.~   "
203181|NCT00902720|"~     The purpose of this study is to offer an alternative method to women who wish to preserve the~     possibility of fertility, as well as to learn more about the ability of human eggs to survive~     and function after long term storage in frozen ovaries (ovarian tissue cryopreservation). The~     study will seek to preserve ovarian tissue and reproductive potential for patients whose~     medical or surgical treatment may harm ovaries or remove ovarian tissue.~   "
203215|NCT00902278|"~     The goal of this research is to find out how the body's immune system responds to different~     manufacturer's flu vaccines.~   "
203186|NCT00902655|"~     Nocturia is defined as waking one or more times to void during the period between going to~     bed with the intention of sleeping and waking with the intention of arising.The~     pathophysiology of nocturia is multifactorial and can be complex. Therefore it is important~     to adopt a systematic approach to identify the possible causal factors of nocturia and to~     treat them accordingly. Patients with nocturia can be categorized as having one of the~     following three disorders: (1) nocturnal polyuria (NP) in which the voided urine volume~     during the hours of sleep exceeds 35% of the 24-hr output, (2) low nocturnal bladder capacity~     (NBC) causing a nocturnal urinary volume greater than the bladder capacity, (3) or mixed~     nocturia, a combination of the preceding two categories.~      Desmopressin, a synthetic analogue of the antidiuretic hormone (ADH), has been used for many~     years to treat diabetes insipidus and primary nocturnal enuresis.More recently, it is also~     known to be effective against nocturia with NP by decreasing night-time urine~     production.However, it may be associated with an increased risk of developing hyponatremia~     due to water retention, especially in elderly patients.In the present study, we investigated~     the safety and efficacy of oral desmopressin for the treatment of mixed nocturia in patients~     with both NP and a low NBC.~   "
203187|NCT00902642|"~     The goal is to acquire more in-depth knowledge on physical therapists' attitudes towards and~     beliefs about psychosocial factors in back pain, how physical therapists integrate~     psychosocial factors into their clinical practice and the effects of a training program for~     physical therapists in psychosocial factors on clinical practice and thereby on patient~     outcome in terms of disability, pain, catastrophizing, and treatment satisfaction.~   "
203188|NCT00902629|"~     The goal of this randomized clinical trial is to investigate when it is optimal to treat the~     eye disease epiretinal fibrosis.~      Hypothesis: In a population of patients with symptomatic idiopathic epiretinal fibrosis and~     visual acuity above 0.4, the best long term outcome measured by visual acuity is achieved by~     early surgery compared to periodic controls until a continual loss of visual acuity has been~     ensure followed by surgery.~   "
203189|NCT00902616|"~     Patients with diabetes have dysfunction of the lining of the arteries which lead to impaired~     circulation in the small blood vessels. This is thought to be secondary to reduced chemicals~     in the blood viz: nitric oxide. This chemical is derived from an amino acid (protein)~     L-arginine. Therefore, the researchers investigated whether giving patients L-arginine~     (versus dummy powder) would improve the blood flow in the small blood vessels in the lower~     limbs of patients with damage to their nerves (neuropathy).~   "
203190|NCT00902603|"~     The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that~     longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been~     receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I~     PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2~     years from the time of enrollment. Data will be collected via patient interview and review of~     the medical record. Quarterly data collection will include capture of medications and~     Ventavis® adherence data.~   "
203191|NCT00902590|"~     This study is being done to create a registry to help us learn more about urinary and other~     cancers. This will let us look at large groups of people who do and do not have this kind of~     cancer.~      The investigators will look at risk factors to learn more about how these impact cancer. The~     investigators will also look at genetic markers. These are genes that are found in a known~     place. They are often associated with a particular trait. If the gene changes in some way, it~     may predict cancer or response to treatment. The investigators will look for markers in your~     saliva.~      This registry will help us develop better methods of:~      Preventing these cancers. Diagnosing these cancers. Treating these cancers.~   "
203192|NCT00902577|"~     This phase II trial is studying how well positron emission tomography (PET) scan using~     18F-fluoromisonidazole works when given together with magnetic resonance imaging (MRI) ) in~     assessing tumor hypoxia in patients with newly diagnosed glioblastoma multiforme (GBM).~     Diagnostic procedures, such as MRI and PET scan using 18F-fluoromisonidazole (FMISO), may~     help predict the response of the tumor to the treatment and allow doctors to plan better~     treatment.~   "
203193|NCT00902564|"~     The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of~     treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of~     patients who respond to escitalopram during the treatment period, and to evaluate safety of~     escitalopram.~   "
203194|NCT00902551|"~     Very few screenings of any kind will be possible during a woman's lifetime in most~     low-resource regions, where 80% of the half-million global cases of cervical cancer occur~     every year. Although a single round of human papillomavirus (HPV) testing was associated with~     a significant decline in the rate of advanced cervical cancers and associated deaths, whether~     other methods like as DNA image cytometry can be used as an more accurate means than others~     in screening cervical cancer or not is yet to be verified. In addition, the accuracy of both~     DNA image cytometry and conventional cytology is not well known. The investigators~     hypothesized that DNA image cytometry was superior in screening cervical cancer than~     conventional cytology.~   "
203195|NCT00902538|"~     Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven~     to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This~     study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive~     patients whose blood pressure is not adequately controlled with OLM/AML alone. The following~     treatments will be included in the trial: OLM 40mg/AML 10mg; OLM 40mg/AML 10 mg/HCTZ 12.5 mg;~     OLM 40 mg/AML 10 mg/HCTZ 25 mg. The trial has four periods. The treatments that will be used~     are as follows:~      Period 1 - OLM 40mg/AML 10mg; Period 2 - OLM 40mg/AML 10mg or OLM 40mg/AML 10 mg/HCTZ 12.5 mg~     or OLM 40 mg/AML 10 mg/HCTZ 25 mg; Period 3 - OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 -~     Period 3 responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 non-responders: OLM~     40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg~   "
203196|NCT00902525|"~     Despite of the availability of treatment for this disease, this study is justified because no~     known therapies are really curative and it is necessary to look for new treatment options to~     improve the clinical outcome and prognosis of relapsed aggressive lymphoma. This study is~     designed for patients not eligible for high-dose chemotherapy and autologous stem cells~     transplantation.~   "
203197|NCT00902512|"~     the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with~     and without water is similar relative to the conventional oral tablet of sildenafil~     administered with water.~   "
203199|NCT00902486|"~     This will be a randomized, double blind, placebo controlled, dose ranging, parallel group~     study. Subjects with active rheumatoid arthritis (RA) who have had inadequate response to any~     disease modifying anti-rheumatic drug (DMARD) therapy including biologics will be enrolled.~     Screening evaluations will be performed within approximately 28 days of randomization. The~     duration of the study is 6 months with the primary endpoint assessed at 3 months. Eligible~     subjects will be randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 or~     placebo.~   "
203200|NCT00902473|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg~     dose under fed conditions.~   "
203201|NCT00902460|"~     CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is~     designed to assess whether co-administration of CP-690,500 and midazolam will effect the~     metabolism of midazolam in healthy volunteers.~   "
203202|NCT00902447|"~     The Human Blood Cell Disorder Tissue Bank will provide a convenient, comprehensive source of~     tissue containing populations of human blood cells from patients with various types of~     lymphoid, myeloid, and erythroid proliferative diseases as well as other associated~     conditions. The tissue bank will continue to be an invaluable asset for understanding of the~     biology of multiple blood cell disorders involving several cell types as well as the~     physiology of normal cellular counterparts affected in these disorders. Internal and external~     investigators will be able to utilize this tissue to test hypotheses relating to the~     immunologic, virologic, genetic, and molecular properties of these abnormal cells as well as~     normal cells from normal unaffected family members or normal aged matched subjects to provide~     better comparisons.~   "
203203|NCT00902434|"~     This is an exploratory analysis that is investigating the pattern of care in patients over~     the age of 80 who were diagnosed with non-Hodgkin lymphoma (NHL). This study will look at the~     dose intensity and density implemented in this patient population to calculate whether~     patients received the full course of therapy, received less duration of treatment, or~     received lower doses of the drugs administered. Furthermore, the investigators would explore~     time to disease progression for these patients regardless of the treatment received and~     investigate whether patient outcomes differ based on the type of therapy or dose~     intensity/density given.~      This study is looking at retrospectively evaluating patients with NHL who are over the age of~     80 at our institution between 2001-2007. It is anticipated that about 50 patients will be~     included in this study.~   "
203204|NCT00902421|"~     The urologic literature suggests that there is an association between a variety of~     psychiatric disorders and incontinence. Most notably, depression is found in a significant~     percentage of patients with urinary incontinence. Depression also occurs in other conditions~     associated with urinary urge incontinence, such as aging and dementia, and in neurologic~     disorders such as normal pressure hydrocephalus. Correction of some neurologic disorders~     eliminates both depression and urge incontinence. Although chronic medical disorders such as~     urge incontinence may lead to depression, an alternative hypothesis is that these two~     conditions share a common neurochemical pathogenesis. Lowering monoamines such as serotonin~     and noradrenaline in the central nervous system (CNS) leads to depression and urinary~     frequency and a hyperactive bladder in experimental animals. Thus, depression may not only be~     the result of persistent urinary incontinence, but individuals with altered CNS monoamines~     could manifest both depression and an overactive bladder. The latter condition may lead to~     urge incontinence, urinary frequency, urgency, or enuresis. Uncovering further evidence for~     such a linkage could serve as the basis for the development of genetic markers and novel~     therapeutic interventions for these two conditions.~      In this study, the investigators will evaluate the efficacy and safety of SSRI on OAB~     patients who does not respond to the antimuscarinic agents.~   "
203205|NCT00902408|"~     After a pilot trial where we showed an substantial increase in plasma lutein levels and a~     increase in macular pigment optical density after only 3 months of daily consumption of a~     lutein-enriched egg-beverage, we now propose to study the effect these changes have on~     subjects with early ( undiagnosed) stages of macular degeneration. Age-related macula~     degeneration, is the leading cause of blindness in many developed countries[1-6] in older~     persons (usually over 55 years of age). Visual compromise rises exponentially after age of~     70[7] with a 5-year incidence of around 1%. The incidence of bilateral AMD in persons with~     unilateral late ARM observed over a period of 10 years of over 50% with a 2.1-2.8% overall~     incidence in study population[8]. To date there is no curative way of fighting AMD. With the~     results of this trial we hope to show that with daily consumption of these enriched beverage,~     we can slow the progression of AMD. (Protocol page 8-10)~   "
203206|NCT00902395|"~     There is lack of clinical trials on pediatric dental sedation. The purpose of this study is~     to test (using a randomized controlled trial design) the hypothesis that young children~     behavior during dental treatment improves with oral midazolam sedation. A further aim of this~     study was is explore whether behavior also changes over sessions needed to dental treatment~     completion.~   "
203207|NCT00902382|"~     To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal~     teratology and dysmorphology, and infant development up to age 3.~   "
203208|NCT00902369|"~     This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical~     Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2:~     Proof of Concept Study~   "
203209|NCT00902356|"~     The primary objective of this study is to determine the safety and tolerability of AMG 167~     following a single dose subcutaneous (SC) or intravenous (IV) administration in healthy men~     and postmenopausal women.~   "
203210|NCT00902343|"~     The purpose of this study is to learn the best method of assigning patients to receive acute~     normovolemic hemodilution during liver surgery.~   "
203211|NCT00902330|"~     RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current~     received through electrodes placed on the earlobes. CES may lessen symptoms in women with~     breast cancer receiving chemotherapy. It is not yet known whether CES is more effective than~     sham therapy in reducing symptoms caused by chemotherapy in women with breast cancer.~      PURPOSE: This randomized phase III trial is studying mild electrical stimulation to see how~     well it works compared with sham therapy in reducing symptoms caused by chemotherapy in women~     with stage I, stage II, or stage IIIA breast cancer receiving chemotherapy.~   "
203216|NCT00902265|"~     Documentation of the efficacy and safety of desmopressin (Nocturin®) 0.1 mg tablet.~     Observation of patients with benign prostate syndrome, in whom nocturia associated with~     nocturnal polyuria is treated with desmopressin (Nocturin®) 0.1 mg tablet focusing on number~     of nocturnal voids, ratio of night/24-h urine volume (%), duration of first undisturbed sleep~     period and quality of life.~   "
203217|NCT00902252|"~     The purpose of this clinical study is to demonstrate that the Vitala™ Continence Control~     Device is both safe and effective when worn up to 12 hours per day.~   "
203218|NCT00902226|"~     The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of~     treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients~     who respond to escitalopram during the treatment period, and to evaluate safety of~     escitalopram.~   "
203219|NCT00902213|"~     This will be the first multidisciplinary, randomized, longitudinal trial of a tailored,~     parent- and child-focused physical activity program for children (ages 4- <19 years) with~     newly diagnosed ALL. It will test the ability of the intervention to prevent or diminish~     early physical function limitations and improve health-related quality of life (HRQL). The~     intervention will be tested for its effect on: 1) physical function outcomes (muscle~     strength, range of motion, endurance, gross motor skills), bone density and bone mineral~     content (end of therapy only); and 2) HRQL. This multi-site trial will test the intervention~     in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo~     minimal movement standard care strategy).~   "
203220|NCT00902200|"~     Double-masked, randomized, multi-center, placebo-controlled parallel-comparison of AR-12286.~   "
203221|NCT00902187|"~     To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus~     Zwickau.~   "
203222|NCT00902174|"~     A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy~     and safety of imatinib as an add-on therapy in the treatment of patients with severe~     pulmonary arterial hypertension (PAH).~   "
203223|NCT00902161|"~     This study will assess the effect of combined treatment with MK0893 plus propranolol versus~     placebo plus propranolol on hypoglycemia.~   "
203224|NCT00902148|"~     Study to investigate and determine the difference between the extent and severity of~     intra-abdominal adhesions in patients where SurgiWrap film was placed compared to patients~     with no adhesion barrier inserted.~      Hypothesis: Due to the preclinical safety data and clinical case reports in various~     indications it is anticipated that the surgical sites where the resorbable anti-adhesion~     barrier SurgiWrap was placed, there will be a reduction of adhesions compared to the control~     group with no treatment.~   "
203225|NCT00902135|"~     Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant~     (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron.~     The Personal digital assistant PDA functions as an electronic diary and as an injection~     reminder.~   "
203226|NCT00902122|"~     This is multicenter, open-label, randomized, active-controled, phase IV study of local direct~     intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or~     combination with surgery for treatment of advanced malignant thyroid tumors.~   "
203227|NCT00902109|"~     The purpose of this study is to compare the two psychophysical perimetric techniques~     regarding progression of the visual field.~   "
203228|NCT00902096|"~     Background: Increased total serum IgE levels are a common characteristic of atopic diseases.~     Increased cord blood IgE levels, in conjunction with a family history of atopy, are~     associated with the development of allergic diseases in children. However, little is known~     about predictors of cord blood IgE levels.~      Objective: The aim of our study was to identify predictors of cord blood IgE levels in an~     ongoing large birth cohort of infants with or without a family history of atopy.~      Methods: Blood sampling of mothers was performed just before the delivery of newborns. Cord~     blood was also collected when the child was born. Maternal and cord blood was measured for~     IgE levels and cytokines. Questionnaires were administered after birth of the infant.~   "
203229|NCT00902083|"~     This is multicenter, open-label, randomized, active-controled, phase IV study of local direct~     intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , or combination~     with surgery for treatment of advanced oral and maxillofacial malignant tumors.~   "
203230|NCT00902070|"~     The main purpose of this investigation is to collect safety and efficacy information of Eslax~     Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as Eslax) in daily clinical~     settings.~   "
203231|NCT00902057|"~     To study, with a prospective randomised controlled design, whether the subcutaneous~     administration of the haemostatic drug desmopressin, may improve the impairment of primary~     haemostasis due to mildly decreased temperature.~   "
203232|NCT00902044|"~     Patients have a type of cancer called sarcoma. Because there is no standard treatment for the~     patients cancer at this time or because the currently used treatments do not work fully in~     all cases, patients are being asked to volunteer to take part in a gene transfer research~     study using special immune cells. This research study combines two different ways of fighting~     disease: antibodies and T cells. Antibodies are proteins that protect the body from diseases~     caused by germs or toxic substances. They work by binding those germs or substances, which~     stops them from growing or exerting their toxic effects. T cells, also called T lymphocytes,~     are special infection-fighting blood cells that can kill other cells, including tumor cells~     or cells that are infected with germs. Both antibodies and T cells have been used to treat~     patients with cancers: they both have shown promise, but have not been strong enough to cure~     most patients. We have found from previous research that we can put a new gene into T cells~     that will make them recognize cancer cells and kill them. We now want to see if we can put a~     new gene in these cells that will let the T cells recognize and kill sarcoma cells. The new~     gene that we will put in makes an antibody specific for HER2 (Human Epidermal Growth Factor~     Receptor 2) that binds to sarcoma cells. In addition it contains CD28, which stimulated T~     cells and make them last longer. In other clinical studies using T cells, some investigators~     found that giving chemotherapy before the T cell infusion can improve the amount of time the~     T cells stay in the body and therefore the effect the T cells can have. Giving chemotherapy~     before a T cell infusion is called lymphodepletion since the chemotherapy is specifically~     chosen to decrease the number of lymphocytes in the body. Decreasing the number of patient's~     lymphocytes first should allow the T cells we infuse to expand and stay longer in your body,~     and potentially kill cancer cells more effectively. We will use fludarabine or the~     combination of cyclophosphamide and fludarabine as the chemotherapy agents for~     lymphodepletion. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly~     used for lymphodepletion in immunotherapy clinical trials. The purpose of this study is to~     find the largest safe dose of chimeric T cells, and to see whether this therapy might help~     patients with sarcoma. Another purpose is to see if it is safe to give HER2-CD28 T cells~     after lymphodepleting chemotherapy.~   "
203233|NCT00902031|"~     The purpose of this study is to determine if docusate is effective in the treatment of~     constipation in palliative care patients.~   "
203274|NCT00901485|"~     The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive~     ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal~     hypoventilation who have never experienced nocturnal, home NIV.~   "
203234|NCT00902018|"~     The purpose of this study is to further evaluate the effects that eltrombopag has on~     platelets in subjects with chronic ITP. Eltrombopag is approved by the Food and Drug~     Administration (FDA) for the treatment of low platelets in patients with chronic ITP. It is~     being further studied by GlaxoSmithKline in other conditions associated with low platelets.~     This research study is being done because eltrombopag has been shown to increase platelet~     counts in a different way than other therapies for ITP. The investigators want to further~     study how eltrombopag affects subjects and their platelets to determine how the study drug~     should best be used in ITP treatment.~   "
203235|NCT00902005|"~     The aim of this study is to examine the associations between inflammatory disease activity~     and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated~     with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or~     methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial~     function, and decrease in bone and cartilage destruction during treatment with the~     combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis~     (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and~     levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).~   "
203236|NCT00901992|"~     A new diabetes education program for the initiation of intensive insulin therapy in type 2~     diabetic patients (MEDIAS 2 ICT) was developed.~      In the evaluation, this new developed program is compared with an education programs which is~     currently used for diabetes education. It is expected that the new developed program (MEDIAS~     2 ICT) can demonstrate non-inferiority with regard to the main outcome variable glycemic~     control. If non-inferiority can be demonstrated superiority of this programs will be tested.~      The results regarding the intervention arms MEDIAS ICT vs.  ACC (control condition) will~     be separately analyzed and published.~   "
203237|NCT00901979|"~     This study will assess the effect of LCQ when added to metformin.~   "
203238|NCT00901966|"~     This K07 Career Development Award application is designed to expand Dr. Dennis career~     development from cancer etiology to cancer prevention and control. The career development~     plan rests on mentoring directed by experts in cancer prevention research and protected time~     to foster my professional development as an independent cancer control researcher. A unique~     population, the Agricultural Health Study (AHS) cohort, will be used to examine sun exposure,~     sun protection behavior, and factors affecting these behaviors regarding the risk of melanoma~     in private pesticide applicators (farmers) and their spouses.~      The research plan proposed to examine skin melanoma within this prospective cohort of private~     applicators (mostly farmers) and their spouses in Iowa and North Carolina (the AHS) in~     association with environmental factors. Specific aim 1 examined the risk of melanoma in the~     AHS cohort using various existing measures of sun exposure adjusted for skin sensitivity and~     sun protection. Subsequently (for aim 2) qualitative research methods were used to design~     appropriate measures of sun exposure, sun protection behavior, and factors affecting these~     behaviors in private applicators and their spouses within the AHS based on the cohort~     analyses.~      Now Aim 3 will be completed by conducting a nested case-control study of melanoma within the~     AHS cohort to examine in more detail sun exposure histories and protective behavior. The~     questionnaire was designed based on findings from the cohort analyses (aim 1) and qualitative~     methods (aim 2). The risk of melanoma will be examined regarding: a) the complex relationship~     of cumulative (sun exposure during each decade of life) and intermittent sun exposure~     (sunburns and sunny vacations), b) factors affecting behavior including attitudes about sun~     exposure and prevention, and c) the use of tanning salons and sunless tanning creams,~     particularly in spouses (expected to be rare overall).~      The final aim is to use the results from the cohort and nested case-control studies to design~     a behavioral intervention, along with short computer automated telephone interview (CATI)~     that can be used in the whole AHS cohort or other farming populations. Funding for such~     studies will be sought through the R01) mechanism as an independent cancer control~     researcher. The behavioral intervention will be based on those factors that are the strongest~     risk factors for melanoma, highly prevalent, and easily modifiable. The behavioral~     intervention will be designed based on knowledge and skill gained from the Career Development~     Plan goals.~   "
203239|NCT00901953|"~     Do migrainous vertigo patients have more pathology in their vestibular system than migraine~     patients without vertigo?~      The aim of this study is to compare the vestibular system of migraine patients with and~     without vertigo in the symptom-free period by vestibular function tests, videonystagmography,~     vestibular evoked myogenic potentials, and subjective visual vertical.~   "
203240|NCT00901940|"~     The purpose of the study is to evaluate and compare the immune response to two vaccines~     against 4 related bacteria: meningococcal serogroups A, C, W−135 and Y. These bacteria can~     cause meningitis and /or septicaemia (blood poisoning). The two vaccines are a~     protein−polysaccharide conjugate vaccine (MenACWY)and a meningococcal plain polysaccharide~     vaccine(MenACWY PS). Both vaccines are licensed and are currently used for travellers to~     areas with a high incidence of invasive meningococcal disease. However, plain polysaccharide~     vaccines are known to be poorly immunogenic in children and they do not stimulate~     immunological memory, apart from the serogroup A component. In contrast, a~     protein-polysaccharide conjugate vaccine against meningococcal serogroups A, C, W−135 and Y~     has been found to be immunogenic in infants and to be able to induce immunological memory.~      The proposed study is a single centre, open−label, randomised, controlled study in 150~     healthy adults aged 18−70 years. The participants will be given either 2 injections of the~     meningococcal protein−polysaccharide conjugate vaccine one month apart, or one injection of~     the meningococcal plain polysaccharide vaccine followed one month later with an injection of~     the meningococcal conjugate vaccine. Blood samples will be collected before immunisation and~     at several time points following immunisations to evaluate the level of meningococcal~     specific antibody induced by two different vaccination regimes. The data derived from the~     study will be relevant in determining which of these vaccines should be used in preference in~     travellers who are receiving immunisation against meningococcal disease before travelling to~     high risk areas. Additionally, a number of scientific questions regarding the nature of the~     immune response to the two vaccines (specifically looking at the white blood cells~     responsible for producing antibodies, known as B cells) and the role of genetic variations in~     influencing the vaccine recipient's immune response will be addressed in the study.~   "
203241|NCT00901927|"~     The goal of this clinical research study is to learn if the combination of bendamustine~     hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma.~      The safety of this drug combination will also be studied.~   "
203242|NCT00901914|"~     The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1~     administered as sublingual tablets in birch pollen allergic subjects.~   "
203243|NCT00901901|"~     This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily~     and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib~     once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients~     who are candidates for potentially curative intervention (i.e. surgical resection or local~     ablation) are not eligible for this study.~   "
203244|NCT00901888|"~     The apelin-APJ system is a relatively new discovery. It has generated interest in part due to~     it's apparent ability to counteract the renin-angiotensin system, which is frequently~     overactive in many cardiovascular disease.~      Angiotensin has a powerful ability to cause blood vessels constrict and reduces their~     diameter. One of the actions of apelin is to cause blood vessels to relax and the~     investigators specifically wish test the hypothesis that apelin will cause blood vessels~     constricted by angiotensin II to relax.~   "
203245|NCT00901875|"~     To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with~     opiate dependence.~   "
203246|NCT00901862|"~     Background: The therapy with pulsed electromagnetic fields (PEFs) has been used as a~     therapeutic modality for at least 40 years. However, their effect in the migraine prophylaxis~     is unclear.~      Objectives: Evaluate the prophylactic effectiveness of the therapy with PEFs in the handling~     of migraines.~      Methodology: Placebo-controlled, randomized, double-blind, crossed clinical study.~   "
203247|NCT00901849|"~     This study will evaluate the feasibility of combining two drugs, Tarceva (an anti-EGFR~     agent), and Rapamycin (an mTOR inhibitor), in children with progressive low-grade gliomas who~     have failed initial conventional treatment. In addition to evaluating the toxicity of this~     drug regimen, the potential efficacy of the regimen will be assessed.~   "
203248|NCT00901836|"~     The goal of this study is to evaluate radiation treatment intended to increase the chance of~     curing your sarcoma and decrease the side effects of proton therapy.~      This study will also look at the tumor tissue that was removed during your initial biopsy and~     your final surgery for information that may help to treat retroperitoneal sarcoma in the~     future.~   "
203249|NCT00901823|"~     This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment,~     two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline~     Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two~     dose levels.~   "
203250|NCT00901810|"~     Accurate length determination of root canal is essential in root canal therapy. Radiography~     has been the conventional method for this measurement but recently several in-vitro studies~     have shown that new generations of Electronic Apex locators are as accurate as radiography in~     length determination. It is hypothesized that the latest generation of Electronic Apex~     locator can produce acceptable results as radiography when used for length determination.~   "
203251|NCT00901797|"~     Study Title: Arthroscopic rotator interval closure in shoulder instability repair - a~     prospective study~      Objective: To evaluate the effect of arthroscopic rotator interval closure (ARIC) on patients~     with recurrent shoulder dislocations undergoing arthroscopic bankart repair (ABR) in terms of~     recurrence, rehabilitation and function.~      Hypothesis:~        1. Although Hyperlax patients undergoing ABR have higher incidence of recurrent shoulder~          dislocations than those without hyperlaxity, adding ARIC will lower the recurrent~          dislocation rate.~        2. Patients with arthroscopic bankart repair (ABR) and ARIC are slower in gaining the range~          of motion (ROM) but within 6 months are equal to those with ABR only.~   "
203252|NCT00901784|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg~     dose under fasting conditions.~   "
203253|NCT00901771|"~     The primary objective of the proposed investigation is to evaluate the efficacy of the~     Provent device in a sample of OSA patients who have either refused or been non-adherent with~     PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent)~     and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be~     assessed. A secondary objective is to assess adherence with Provent treatment during the~     5-week evaluation period.~   "
203254|NCT00901758|"~     Breech presentations (where a baby presents with feet or bottom down) have an increased risk~     of perinatal and neonatal complications, and are usually delivered by cesarean section. As an~     alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the~     baby so that it is head down: this manoeuvre is called an external cephalic version (ECV).~      Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success~     rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested~     as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in~     women who have not previously been pregnant (nulliparous women) than in women who have been~     pregnant more than once (multiparous women), and so we have planned two trials.~      This study is designed to answer the following questions for multiparous women:~      Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates?~     Will an increase in ECV success result in a decreased cesarean section rate?~   "
203255|NCT00901745|"~     The apelin-APJ system is a relatively new discovery. It has generated interest in part due to~     it's apparent ability to counteract the renin-angiotensin system, which is frequently~     overactive in many cardiovascular disease.~      Apelin has the ability to cause blood vessels to relax, increasing their diameter and hence~     blood flow down the blood vessel. The researchers wish to investigate the hypothesis that an~     infusion of apelin will reduce the effects of angiotensin II, which is know to reduce the~     diameter of blood vessels.~   "
203256|NCT00901732|"~     Patients who have been diagnosed with a head and/or neck cancer commonly develop oral~     mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to~     evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral~     intake, swallowing function and pain.~   "
203257|NCT00901719|"~     The apelin-APJ system is a relatively new discovery. It has generated interest in part due to~     it's apparent ability to counteract the renin-angiotensin system, which is frequently~     overactive in many cardiovascular disease.~      Two of the main actions of apelin are to increase the pumping ability of the heart and cause~     blood vessels to relax. The investigators wish to assess if these actions are altered in the~     setting of normal renin-angiotensin activation and increased renin-angiotensin activity.~   "
203258|NCT00901706|"~     This study is designed to assess the best method for caring for elders reported to Adult~     Protective Services (APS) for self-neglect. Specifically, this study will compare APS usual~     care coupled with interdisciplinary comprehensive geriatric care to APS usual care alone in~     improving the health and quality of live among elders with substantiated self-neglect.~   "
203259|NCT00901693|"~     The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic~     Solution for the treatment of adenoviral conjunctivitis.~   "
203260|NCT00901680|"~     To establish a multidisciplinary research structure for tissue repository that facilitates~     projects that bridge specialties that normally may or may not interact.~   "
203261|NCT00901654|"~     The purpose of this study is to evaluate the safety and immune response to ACE527.~   "
203262|NCT00901641|"~     The purpose of this study is to investigate the effect of computerized, home-based cognitive~     training on sleep quality of older adults with insomnia.~   "
203275|NCT00901472|"~     The hypothesis of this study is: sleep disordered breathing (SDB), specifically, obstructive~     sleep apnea, is associated with poorer glucose in the existing type 2 diabetic condition.~      In an exploration of this hypothesis, the investigators hope to provide evidence linking SDB~     to increased severity of disease in the type 2 diabetic patient. By doing so, the~     investigators ultimately seek to support investigating the use of SDB interventions as an~     additional method of care in the treatment of type 2 diabetes.~   "
203263|NCT00901628|"~     The purpose of this study is to determine whether periarticular multimodal drug injection~     (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for~     whom contemporary pain control protocols using the continuous femoral nerve block,~     intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We~     hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer~     and would provide better functional recovery and patient satisfaction. We also hypothesized~     that the incidence of side effects and complications of the PMDI would be similar to the~     No-PMDI.~   "
203264|NCT00901615|"~     The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid)~     when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin,~     vincristine and prednisone).~   "
203265|NCT00901602|"~     Streptococcus pneumoniae (pneumococcus) is a bacterium that causes severe infections in~     children and adults such as meningitis, pneumonia, and blood stream infection. There are many~     types of these bacteria defined by the type of sugar coat that they have. These are~     classified as serotypes. There are common serotypes that cause severe disease and are~     preventable by vaccination of children. Other less common types are more difficult to~     prevent. The investigators aim to determine the serotypes that cause invasive pneumococcal~     disease in Lebanon and to study their sensitivity to different antibiotics. The investigators~     will collect bacterial isolates from different hospitals in Lebanon isolated from the blood~     or spinal fluid of patients with invasive pneumococcal disease. This information will help~     the investigators determine the usefulness of available pneumococcal vaccines in preventing~     these infections. The data will be distributed to all primary care physicians treating~     children in Lebanon and will be shared with the Ministry of Health.~   "
203266|NCT00901589|"~     The study is a randomised placebo controlled double-blinded clinical trial where a group of~     healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or~     placebo oil capsules for 12 weeks. Anthropometric measurements(weight, height,blood pressure)~     blood samples and adipose tissue biopsies will be taken in order to illustrate the effect of~     marine n-3 PUFAs (fish oil) on the concentration of circulating female hormones and to~     investigate what impact menopause might have on the ability to incorporate marine n-3 PUFAs~     into tissues.~   "
203267|NCT00901576|"~     This is a drug-drug interaction study; the purpose of this study is to examine the~     pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and~     Concerta (methylphenidate HCl) when given alone, and in combination.~   "
203268|NCT00901563|"~     Hypothesis - Rotigaptide will improve endothelial function in the context of endothelial~     dysfunction.~      The lining of blood vessels (endothelium) can react to hormones in the blood stream causing~     the blood vessel muscle to relax (vasodilatation) and allow more blood to flow. The nitric~     oxide and prostacyclin pathways are well documented in this process. However, evidence points~     to the existence of a third powerful relaxant called endothelium derived hyperpolarising~     factor (EDHF) but its identity and mechanism of action have proved elusive. As well as~     causing blood vessels to relax and more blood to flow, EDHF may be involved in the~     endothelium signaling, triggering release of a specialised clot dissolving factor called~     tissue plasminogen activator (t PA). t PA is important to ensure small clots, which are~     constantly being formed in the circulation, are rapidly dissolved and do not grow large~     enough to cause heart attacks and strokes.~      Evidence points towards the requirement for 'gap junctions' in the mediation of EDHF~     responses. Gap junctions are specialised pores which allow small molecules and charge to pass~     between cells. They are found between endothelial cells and the underlying muscle of the~     blood vessel. A drug called Rotigaptide has been developed to cause gap junctions to open. It~     has been safely administered in healthy volunteers and is now in a Phase II drug trial. By~     opening gap junctions the investigators hypothesise that it could increase EDHF mediated~     activity and vasodilatation. It represents a useful tool with which to examine the role of~     gap junctions in EDHF activity in vivo.~      Previously the investigators have demonstrated that rotigaptide does not contribute to~     endothelial function in healthy volunteers. The investigators now wish to examine the effect~     of rotigaptide in conditions of endothelial dysfunction. By limiting the blood flow to the~     arm for 20mins the ability of the blood vessel to vasodilate is impaired. By administering an~     intra−arterial rotigaptide infusion the investigators want to assess any functional~     preservation.~   "
203269|NCT00901550|"~     The purpose of this study is:~        1. To ascertain whether the quantitative assessment of enhancing synovial volume and~          perfusion indices on serial Magnetic Resonance Imaging (MRI) examination are useful~          indicators of responsiveness to treatment in early Rheumatoid Arthritis (RA) using~          biologic therapy and Methotrexate (MTX) compared with Methotrexate(MTX) alone.~        2. To assess the cost-effectiveness of Tumor Necrosis Factor (TNF) blockers compared with~          Methotrexate(MTX) monotherapy for Rheumatoid Arthritis(RA).~   "
203270|NCT00901537|"~     The standard of care for head and neck and lung cancer includes chemotherapy, radiation and~     surgery. For patients with cancer of head and neck or lung that recurs after surgery and/or~     radiation, or has spread to other parts of body, chemotherapy using cisplatin can slow down~     tumor growth and extend lifespan.~      The study drug, azacitidine, can block the ability of some cancer cells to replicate, and has~     been approved by the Food and Drug Administration for use in myelodysplastic syndrome, which~     is a slowly developing blood cell-related cancer. In laboratory and animal experiments using~     head and neck and lung cancer cells, azacitidine has been shown to be a cisplatin helper,~     (that is, it makes cisplatin more effective in stopping the growth of head and neck and lung~     cancer. )~      Since the combination of azacitidine and cisplatin has not been used in patients with head~     and neck or lung cancer, the investigators are performing this study combining azacitidine~     and cisplatin to find out what effects, good and/or bad, the study drug may have on patients~     with advanced head and neck or lung cancer. The investigators are doing this study because~     they would like to find a better treatment for these types of cancer.~   "
203271|NCT00901524|"~     The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment~     (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.~   "
203272|NCT00901511|"~     The investigators designed an experimental, randomized by parallel groups, stratified~     according to previous treatment, open-label study evaluating the superiority of the~     combination of whole lung lavage/inhaled GM-CSF versus whole lung lavage alone in patients~     with pulmonary alveolar proteinosis. The primary efficacy objective is the total resolution~     of the pulmonary involvement. PAP patients matching the enrolment criteria will enter the~     study. If requiring the first WLL, they will be randomized to receive WLL (1st level control~     group) or WLL/followed by inhaled GM-CSF, according to an acute (12 weeks) followed by~     maintenance (6 months) schedule (1st level treated group).~   "
203273|NCT00901498|"~     The purpose of this study is to assess the bioavailability of four experimental formulations~     relative to the current reference formulation used in the Phase 2 study.~   "
213711|NCT00762567|"~     To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children,~     ages 2 to <12 years, and adolescents, ages 12 to <18 years.~   "
203276|NCT00901459|"~     The purpose of this study is to investigate the use of repetitive transcranial magnetic~     stimulation (rTMS) to block craving for cigarettes in smokers. rTMS is an investigational~     procedure, where a device called a stimulator provides electricity to a device that creates~     a magnetic field. This device is placed against the scalp in the front of the head so that~     the magnetic field is focused on an area of the brain that is thought to be involved in~     craving for cigarettes. rTMS is an investigational procedure so therefore being tested in~     research studies and is not approved by the U.S. Food and Drug Administration (FDA). Changes~     in magnetic fields during rTMS administration change electrical currents which may affect~     brain activity and function.~   "
203277|NCT00901446|"~     This study is designed to evaluate the technical performance and clinical handling of a~     coronary catheter that includes two imaging techniques. The catheter being evaluated performs~     near infrared spectroscopy and ultrasound imaging of the coronary arteries. Near infrared~     spectroscopy is used to identify lipid or cholesterol deposits in the vessel wall and the~     ultrasound component provides structural information about the vessel. Combining multiple~     imaging techniques into a single catheter can reduce the total number of catheters required~     during treatment and the overall duration of cardiac catheterization. Both of these results~     may lead to safer procedures.~   "
203278|NCT00901433|"~     The NAEPP (National Asthma Education and Prevention Program) guidelines recommend that~     spirometry be performed on patients with asthma because they serve as an objective measure of~     airway obstruction. Unfortunately, most children under 5 years of age are unable to perform a~     forced expiratory maneuver making conventional spirometry unavailable in this age group in~     most venues. Furthermore, other population groups such as retarded people, elderly or~     physically handicapped share the same difficulty.~      Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer~     that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence~     of wheezing. This usability study was designed to test independent home use and device~     interface effectiveness of the Personal WheezoMeter in order to validate its safe and~     effective use by intended users.~   "
203279|NCT00901420|"~     Objectives:~      The primary objective of this study is to determine whether bladder compliance is~     significantly lower in men who undergo prostatectomy for recurrence following primary~     radiation therapy than in men who undergo prostatectomy as primary treatment.~      The secondary objective is to examine the quality-of-life items addressed in the UCLA~     Prostate Cancer Index for differences between the two populations. The investigators will~     also look at secondary objective urodynamic measures, such as bladder capacity, to assess for~     a difference.~   "
203280|NCT00901407|"~     This study is intended to evaluate the efficacy and safety of lamotrigine as an~     antidepressant augmentation agent in a sample of individuals with major depression and a~     history of both prior non-response and prospective failure to respond to at least one~     adequate trial of an antidepressant (for a total of two failed trials).~   "
203281|NCT00901394|"~     The goal of this study is to find out if giving intravenous B-vitamins before general~     anesthesia with nitrous oxide prevents the increase in homocysteine, a metabolite that has~     been linked to cardiovascular complications.~   "
203282|NCT00901381|"~     The aim of the study is to investigate treatment with Leukostim (Filgrastim;~     granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke.~   "
203283|NCT00901368|"~     Double blind, multinational, multicentre, randomised, 2 arm parallel group study~   "
203284|NCT00901355|"~     Introduction: High blood pressure especially systolic hypertension is a common condition in~     the elderly and is considered as a major determinant not only of cardiovascular (CV)~     morbidity and mortality, but also of several other age-related diseases, frailty and loss of~     autonomy. Actually, the association between BP levels and morbidity and mortality in the very~     elderly persons with several co-morbidities remains a controversial issue~      Objectives: The aim of the PARTAGE study (Predictive values of blood pressure and arterial~     stiffness in institutionalized very aged population)is to determine the predictive value of~     blood pressure (BP) and arterial stiffness for overall mortality, major cardiovascular events~     and cognitive decline in a large population of institutionalized subjects aged 80 and over.~      Methods: The population is composed of 1130 subjects aged over 80, living in nursing home,~     included by four french university hospitals centre (Nancy, Dijon, Paris, Toulouse) and two~     Italian (Cesena, Verona). Subjects with severe dementia and a very low level of autonomy are~     excluded from the study During the first visit, blood pressure were measured using an~     automatic monitor by physician in sitting and standing position (clinical BP and Orthostatic~     BP) and by a self measurement of blood pressure 3 measurements, in the morning and the~     evening, during 3 consecutive days).~      Arterial stiffness is evaluated by measuring the carotid-femoral and carotid-radial pulse~     wave velocity (PWV) with the PulsePen® automatic device. Deaths and cardiovascular events are~     recorded during a follow-up of 2 years.~      The hypothesis of the PARTAGE longitudinal study is that in very elderly frail individuals~     with multiple co-morbidities, CV risk could be better evaluated by combining~     self-measurements of BP and direct evaluation of arterial stiffness which are less influenced~     by the above mentioned disease and co-morbidities.~   "
203285|NCT00901342|"~     This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic~     Castrate Resistant Prostate Cancer (CRPC).~   "
203286|NCT00901329|"~     The purpose of this trial is to study potential differences between two prostheses,~     including: feel of prosthesis (i.e., how natural does the prosthesis feel), range of motion~     (ROM), pain perception for each prosthesis, satisfaction, patella tracking and quantification~     of the removed bone anterior on the femur (weight).~   "
203287|NCT00901316|"~     The primary purpose of this study is to determine if adding bleach baths to routine ways for~     prevention of Staph infections is helpful. The amount added is a very weak amount. This would~     provide a relatively inexpensive method to help prevent recurrent skin infections caused by~     the Staph germ. The investigators will also be studying how often Staphylococcus aureus lives~     in the nose, throat, and groin area.~   "
203288|NCT00901303|"~     The primary objective of the study is to determine the progression-free survival [PFS] at 36~     months for patients with Hodgkin lymphoma who achieve a complete metabolic response as~     demonstrated by a negative fluorodeoxyglucose (FDG)-PET scan after one cycle of ABVD~     (adriamycin, bleomycin, vinblastine, dacarbazine) who undergo abbreviated ABVD chemotherapy~     (3 cycles).~   "
203289|NCT00901290|"~     The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the~     pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive~   "
203302|NCT00901121|"~     The purpose of the study was to test a clinically relevant non-inferiority of Straumann~     BoneCeramic treatment compared to Bio-Oss treatment 180 to 240 days after sinus grafting~     procedure.~   "
203303|NCT00901108|"~     The purpose of this study is to compare the efficacy and safety of Trabectome versus~     Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with~     open angle glaucoma.~   "
203290|NCT00901277|"~     The study is a three-arm design where up to 600 patients hospitalized post-MI are recruited~     from a large hospital and randomized to either the education group (control group) or one of~     the two intervention groups. Patients randomized to one of the intervention groups will~     receive a nurse-administered intervention plus the use of Microsoft's HealthVault web-based~     platform or solely the use of Microsoft's HealthVault web-based platform and web-based~     behavioral intervention, both of which includes a behavioral/medication management component.~     The 12 months effects of the intervention will be evaluated.~      For baseline and outcome assessments we will obtain BP, nonfasting LDL, and Hb A1c. Patients~     will also be surveyed about demographics and health behaviors during the baseline and 12~     months. Study personnel serve as a liaison between subjects and their providers; however, all~     decisions related to clinical care are ultimately left up to the patient's provider. Subjects~     with serious adverse effects will be advised and assisted in seeking emergency medical care.~   "
203291|NCT00901264|"~     The purpose of this study is to correlate the results of the MICK assay with short- and~     long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in~     guiding chemotherapy of cancer patients.~   "
203292|NCT00901251|"~     The purpose of this study is to evaluate the reproducibility of over active bladder symptom~     score (OABSS) in Asian countries.~   "
203293|NCT00901238|"~     Conventional treatments of retinoblastoma involves laser photocoagulation, cryotherapy~     (freezing of the tumor), plaque radiotherapy,external beam radiotherapy, and intravenous~     chemotherapy. Enucleation (removing of the eye)is the last option when the tumor cannot be~     controlled otherwise. However,many children with retinoblastoma present with advanced~     intraocular disease for which enucleation is the only option. Intra-arterial chemotherapy~     (Chemosurgery)delivers anti-tumor drug directly into the ophthalmic artery (the artery~     feeding the eye) in order to increase the dose of drug reaching the tumor while minimizing~     toxicity to the rest of the body.~   "
203294|NCT00901225|"~     Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte~     colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both~     healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via~     apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008,~     Plerixafor received approval from the Food and Drug administration for use in combination~     with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is~     not designed to support approval of a new indication or change in the advertising for~     Plerixafor. The route of administration and dosage level are identical to that which is~     listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins~     Lymphoma, there is no known or theoretic increased risk of the use of this drug in this~     patient population.~      The study hypothesis for this study is that patients with a circulating CD34+ count < 20~     cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X~     10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.~   "
203295|NCT00901212|"~     Heart failure is a major health problem in Canada. Recent advances in medical and device~     therapy have helped to reduce the morbidity and mortality of patients with this problem.~     Among these treatments, cardiac resynchronization therapy (CRT) has very recently been shown~     to be effective to improve functional class, quality of life and exercise tolerance of the~     patients with the most severe symptoms of heart failure and a prolonged duration of the QRS~     on the 12-lead Electrocardiography (ECG).~   "
203296|NCT00901199|"~     This is a small pilot study looking at the safety of giving combination chelation with Exjade~     and Desferal to 15 patients. The hypothesis is that combination chelation is safe in~     decreasing overall iron in patients with thalassemia.~   "
203297|NCT00901186|"~     This study will assess the efficacy and safety of ranibizumab (intravitreal injections)~     versus laser treatment in patients with visual impairment due to diabetic macular edema.~   "
203298|NCT00901173|"~     Background:~        -  Esophageal cancer is the sixth leading cause of cancer deaths worldwide. Two primary~          cell types, squamous cell carcinoma and adenocarcinoma, account for most cases. Of the~          two, esophageal squamous cell carcinoma (ESCC) accounts for more than 80 percent of all~          deaths from esophageal cancer. Many cases occur in certain areas with defined geographic~          boundaries, including parts of Kenya.~        -  Studies of ESCC in developed countries (such as the United States) suggest that heavy~          tobacco and alcohol use, poor diet, and low socioeconomic status are the primary risk~          factors. Males and African Americans are also at higher risk. However, these risk~          factors do not fully explain the prevalence of cases in several of the identified~          geographic areas.~        -  ESCC is the most common cancer seen at Tenwek Hospital in western Kenya, and a notable~          number of patients are 30 years of age or younger.~      Objectives:~        -  To test the feasibility of a new protocol by recruiting visitors to Tenwek Hospital and~          volunteers from the general population for study purposes.~        -  To use the new protocol to obtain blood and urine samples from ESCC cases in Tenwek~          Hospital and from nonpatient volunteers.~      Eligibility:~        -  Hospital patients and volunteers who live within 50 kilometers of Tenwek Hospital in~          western Kenya.~      Design:~        -  All participants will complete a questionnaire and provide blood and urine samples for~          testing.~             -  The questionnaire will include questions about individual and family medical~               history, living conditions, lifestyle, habits, and diet.~             -  Blood and urine samples will be collected from all participants after the~               questionnaire.~        -  Biological samples will be shipped to the United States for further testing.~        -  Treatment will not be offered as part of this study.~   "
203299|NCT00901160|"~     Can a post-operative analysis using a simple blood test (Thromboelastography(TEG®)) and~     Platelet Mapping Assay (PMA™) be able to detect the occurence of clotting or bleeding~     complications in patients on blood thinning (anti-platelet) agents?~   "
203300|NCT00901147|"~     The purpose of this study is to determine whether intravenous Bortezomib combined with oral~     Panobinostat (LBH589) are effective in treating adult patients with relapsed/refractory~     peripheral T-cell lymphoma or NK/T-cell lymphoma after the failure of conventional~     chemotherapy.~   "
203301|NCT00901134|"~     Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of~     cardiac arrest are advancing, however, survival rate is still very low in the world.~     Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality~     after successful resuscitation which is urgent issue to be solved. Therapeutic hypothermia is~     part of a standardized treatment strategy for comatose survivors of cardiac arrest in the~     metabolic phase usually about 15 minutes after cardiac arrest. However, the evidences of the~     efficacy of therapeutic hypothermia are still few. The optimal candidates, temperature, the~     timing of initiation, the therapeutic windows and the rate for rewarming have not been~     defined clinically and should be established. The purpose of this research is the improvement~     in the outcomes for patients with coma after resuscitation from out-of-hospital cardiac~     arrest using therapeutic hypothermia established from the analysis of multicenter registry~     data.~   "
203304|NCT00901095|"~     The goal of the study is to investigate the efficacy of an evidence-based weight loss~     intervention, on a background of quality health care, on asthma control among obese adults.~     The intervention will employ a combination of recommended dietary and physical activity~     changes, and behavioral modification techniques.~   "
203305|NCT00901082|"~     Patient presenting to chronic pain clinics frequently undergo diagnostic and therapeutic~     spinal injections as part of their treatment. These procedures can cause significant level of~     apprehension in patients, which can lead to increased procedural times, increased procedural~     pain and reluctance to continue with the treatment program. It appears that certain~     interventions could reduce the anxiety and catastrophization levels and modify pain~     perception during medical procedures. The investigators therefore sought to evaluate the~     effect of a single 30 minutes information session which includes relaxation training~     administered 5 to 6 days before the nerve block procedure on patient's anxiety and~     catastrophization levels prior to the procedure and pain scores during the procedure, as well~     as the overall level of satisfaction with care received.~   "
203306|NCT00901069|"~     This is a phase I, prospective, open label, dose escalation study of azacitidine in~     combination with rituximab, vincristine, and cyclophosphamide for the treatment of refractory~     lymphoma. The investigators expect to enroll 12-24 patients in this trial over a 2 year~     accrual period.~   "
203307|NCT00901056|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients~     with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.~   "
203308|NCT00901043|"~     The purpose of this study is to examine the effects of sustained walnut consumption on~     endothelial function and lipid markers in patients with Type 2 diabetes mellitus.~   "
203309|NCT00901030|"~     This study will examine the degree of blood thinning (platelet function) in patients coming~     for non-cardiac surgery on antiplatelet agents using platelet function tests called~     thromboelastography (TEG) and platelet mapping assay (PMA) and major cardiac complications~     that occur any time after surgery (perioperative).~   "
203310|NCT00901017|"~     The objective of the study is to test the efficacy on bone formation of Straumann Bone~     Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed~     oral implants.~   "
203311|NCT00901004|"~     The purpose of this study is to define the endoscopic findings of minimal change that is~     significant to clinical significant reflux esophagitis. Through this, the investigators want~     to estimate the applicability of minimal change findings of reflux esophagitis to the clinic.~   "
203312|NCT00900991|"~     A single center, stratified, randomized and double-blind phase II clinical trial was~     conducted in children to evaluate the safety and immunogenicity of an split-virion pandemic~     influenza A vaccine (H5N1).~   "
203313|NCT00900978|"~     Nasopharyngeal (NP) colonization of S. pneumoniae in infants is generally acquired at~     approximately 4-6 months of age. Although there are differences in the prevalence and rank~     order of serotypes obtained from NP specimens and from those with invasive diseases,~     pneumococcal nasopharyngeal isolates may reflect the strains circulating in the community and~     may be used as a marker to predict serotype prevalence of invasive disease and resistance~     patterns. The information about pneumococcal strains found in Jordanian children and~     NP-carriage of infants is limited and do not include children living in rural regions.~     Monitoring serotype distribution is essential for the appropriate application of vaccination.~     Vaccine use in infants proves to be highly efficacious in the prevention of invasive~     pneumococcal disease as well as in decreasing the carriage of vaccine serotypes in the~     nasopharynx of infants which impacted significantly in the long run on otitis media infection~     and helped decrease the infection rates among contacts of these infants. The result has been~     a decrease in the pneumococcal infection rate among elderly contacts of these infants and~     decrease colonization with pneumococci. In order to determine the pneumococcal serotypes~     which are prevalent among infants attending day care centers (DCCs) in Jordan, a study of~     these types circulating among infants will be determined over a period of 15 months in~     250-300 children attending the DCCs in Ajlun-City by taking 3 NP-swabs, the first before the~     first vaccine injection in May 2009, the second before the third injection at 10 months of~     age and the third swab sample is taken at 1 year of age (2-3 months after the last injection~     with the 7vPCV. The aims of this study were to determine the frequency of NP-carriage and~     serotype distribution of the strains isolated from infants less than 2 years old, and to get~     an insight about the coverage of the available and future pneumococcal conjugate vaccines~     developed for this infectious agent. Good results of this study project would make~     recommendations for the Ministry of Health (MOH) to include the vaccine in the National~     Vaccination Program. 15000 doses of the 7v PCV (Prevenar) were donated from Wyeth~     Pharmaceutical company to the MOH of Jordan in September 2008. These will be vaccinated in a~     vaccine program (for free) over 15 months period in 2009-2010 in one city in north Jordan~     called Ajlun. This city has 3676 births per year (Statistics of the MOH 2007). The~     vaccination program will start from the 18th of May, 2009, and ending in August 2010. The way~     the vaccine will be given is 2 + 1 injections as recommended by the vaccination committee of~     the MOH.~   "
203314|NCT00900965|"~     Irritable bowel syndrome (IBS) is the most common digestive disorder that affects more than~     5% of population in Hong Kong. However, there is no effective treatment of IBS using Western~     Medicine. Acupuncture, a traditional therapeutic modality, has been used in China for~     thousands of years for various pain disorders. In addition to analgesia, acupuncture has also~     been shown to influence physiology of gastrointestinal tract. The investigators set out to~     evaluate the therapeutic value of acupuncture in IBS. The investigators will study its~     effects on rectal sensation and brain activity in patients with IBS.~      All patients will be evaluated for study eligibility at visit 1 (baseline). Baseline~     assessment includes individual IBS symptoms (pain/discomfort, bloating, constipation, and~     diarrhea) as perceived by patients will be scored. The syndrome of IBS patients will also be~     recorded and analyzed based on the Chinese medicine theories. All patients will then undergo~     baseline rectal barostat for thresholds of rectal sensation. At visit 2, eligible patients~     will be randomly assigned to either (1) electroacupuncture or (2) sham electroacupuncture~     treatment groups. Functional Magnetic Resonance Imaging (fMRI) scanning will be performed~     before, during and after the electroacupuncture or sham electroacupuncture treatment.~   "
203315|NCT00900952|"~     The purpose of this observational study is to assess the prevalence and demographic and~     clinical characteristics of infections in elderly people admitted to Internal Medicine wards~     in Spain, as well as the etiology and resistance pattern for the main causal agents, and~     outcome.~   "
203316|NCT00900939|"~     The purpose of this study is to determine if a low-fat, vegan diet affects the number of acne~     lesions, acne severity, and acne extent.~   "
203317|NCT00900913|"~     The purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine~     on the receptive field of primary sensory afferents and their influence on the vascular bed.~      *Trial with medicinal product~   "
203333|NCT00900692|"~     The purpose of this study is to examine range of motion and lasting effects of Botox~     injections along with the use of the Supination Dynasplint.~   "
203318|NCT00900900|"~     This study will evaluate the potential therapeutic value of two neurosteroid treatments (DHEA~     and pregnenolone) in the treatment of tobacco withdrawal symptoms. This will include~     assessing whether these agents relieve craving for cigarettes elicited by exposure to a~     mildly stressful cognitive task. Pregnenolone (400 mg orally), DHEA (400 mg orally) and~     placebo will be administered one at each of the three sessions in a randomized order.~   "
203319|NCT00900887|"~     The purpose of this study is to determine the efficacy of ocular topic antiinflammatory~     therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness~     secondary to selective photocoagulation in diabetics with clinically significant macular~     edema.~   "
203320|NCT00900874|"~     The hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled~     Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e.,~     the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1,~     5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute~     exacerbation of asthma.~   "
203321|NCT00900861|"~     A prospective study led amongst pulmonologists. Patients asthma control level will be~     evaluated based on GINA guideline criteria. HRQoL measured by Visual analogue scale. Clinical~     practice: non controlled patients therapy assessed.~   "
203322|NCT00900848|"~     Traumatic disruption of iliofemoral arterial segment is often associated with multiple~     injuries, massive hemorrhage, state of shock, and loss of blood supply to the ipsilateral~     lower extremity, as well as with high mortality.~      The investigators describe a bypass technique. It can provide adequate blood supply to the~     lower extremity of the injury side. Due to a minimum amount of additional blood loss, it is a~     low risk procedure for salvage of the extremity and even patient's life.~   "
203323|NCT00900835|"~     RATIONALE: Collecting information over time about patients' and health care providers'~     understanding of pain and fatigue and providing education about pain and fatigue management~     may improve quality of life.~      PURPOSE: This clinical trial is studying pain and fatigue management in patients with breast~     cancer, prostate cancer, colon cancer, or lung cancer.~   "
203324|NCT00900822|"~     Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is~     a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is~     evaluated. The patients are followed for 3 years.The study hypothesis is that the SBC is not~     worse than BioOss.~   "
203325|NCT00900809|"~     NK cells from patients with malignant diseases are often functionally impaired. Their~     function cannot be fully restored through ex vivo expansion and cytokine activation. In~     addition, the in vivo administration of cytokines not only expands NK cells but expands~     polyclonal T cells with no tumor specificity and no known effects.~      The utilization of Neukoplast™, as a form of adoptive immunotherapy, offers several~     advantages. Neukoplast™ represents a uniform cell population with a well-characterized~     immunophenotype, confirmed strong anti-tumor activity and are easy to grow and expand in~     culture, so that they can be made available in large numbers for therapeutic delivery.~   "
203326|NCT00900796|"~     The objective of this observational study is to determine the incidence of response in~     patients with predictive factors of major clinical response in active ankylosing spondylitis~     (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these~     findings in patients who switch from one to another anti-TNF due to inefficacy under usual~     clinical practice conditions in Spain.~   "
203327|NCT00900783|"~     The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to~     valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent~     in cells infected with varicella zoster virus, the virus that causes shingles. The study~     objectives include:~        -  Compare the safety of FV-100 to valacyclovir~        -  Compare the effect of FV-100, as compared to valacyclovir, on shingles pain~        -  Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions~   "
203328|NCT00900770|"~     The purpose of this study is to determine whether asymptomatic older individuals with high~     amyloid burden will subsequently manifest cognitive impairment and eventually progress to~     clinical Alzheimer's Disease (AD).~   "
203329|NCT00900757|"~     1. Purpose and objective:~        1. To determine the safety and tolerability of palonosetron in the prevention of radiation~          induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT)~          and concomitant temozolomide (TMZ).~        2. To determine the efficacy of palonosetron in primary glioma patients receiving six weeks~          of RT and concomitant TMZ~        3. To evaluate the effect s of palonosetron on the quality of life of primary glioma~          patients receiving six weeks of RT and Concomitant TMZ.~      2. Study activities and Population group: We will conduct a phase II single arm trial of~     Palonosetron (PALO) for the prevention of RINV in primary malignant glioma patients receiving~     radiation therapy (RT) and concomitant temozolomide (TMZ). All eligible patients should~     receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for~     a total of six weeks of treatment. For each week of radiation patients will receive a single~     0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction.~     This schedule will be repeated for each week of radiation for a total of 6 weeks. Forty~     subjects with gliomas will participate.~      3. Data analysis and risk/safety issues: The frequency of toxicity will be summarized by type~     and the most severe grade experienced. The complete response rate, defined as the proportion~     of patients with no emetic episode or use of rescue medication while receiving radiation and~     concomitant temozolomide, will be estimated with a 95% confidence interval.~   "
203330|NCT00900744|"~     The investigators plan to examine endoxifen and 4-OH-Tam as a function of the tamoxifen dose~     in patients with a genetic CYP2D6 polymorphism. The investigators also plan to investigate~     other genetic variations in the metabolism of tamoxifen.~   "
203331|NCT00900731|"~     This study compared the lung effects of indacaterol to those of tiotropium in patients with~     moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.~   "
203332|NCT00900718|"~     The purpose of this study is to compare a new biomaterial with an already existing treatment~     principle (Bio-Oss/Bio-Gide) with regard to their ability to preserve the dimensions of the~     alveolar ridge and to promote bone regeneration and to evaluate the early survival rate of~     dental implants placed in the augmented socket area and to assess radiographically and~     clinically changes of peri-implant soft and hard tissues.~   "
203334|NCT00900679|"~     RATIONALE: A teaching intervention with an advanced practice nurse may help reduce~     psychosocial and symptom distress and improve the well-being and quality of life of patients~     with ovarian cancer.~      PURPOSE: This clinical trial is studying the effects of a teaching intervention with an~     advanced practice nurse on quality of life and psychosocial and symptom distress in patients~     with ovarian cancer.~   "
203335|NCT00900666|"~     Stiff knee gait is a common gait dysfunction following acquired brain injury. This gait~     deviation is characterized by reduced knee flexion during swing phase of the gait cycle and~     adversely impacts safe foot clearance. Stiff knee gait is an inefficient gait pattern and~     slows walking speed, limiting one's ability to adapt walking to community mobility demands.~     Fall risk is increased with this gait problem due to low or ineffective foot clearance.~     Common compensatory strategies are employed, such as circumduction, hip hiking or vaulting,~     during ambulation.~      The purpose of this study is to examine both the immediate (one month post-injection) and~     longer-term (4 months post-injection) effects of botulinum toxin injections to the rectus~     femoris (RF) on gait function in persons with brain injury. This study is clinically~     important to help inform rehabilitation professionals regarding treatment decisions for~     management of inefficient and often unsafe stiff knee gait problems following brain injury.~      Research Questions:~        -  Is there a statistically significant difference in mean peak knee flexion between the~          experimental and control group?~        -  Is there a statistically significant difference in mean peak knee velocity during the~          preswing and initial swing phases of gait between the experimental and control group?~        -  Is there a statistically significant difference in gait function (based on 6-Minute Walk~          time and temporal distance measures) between the experimental and control group?~   "
203336|NCT00900653|"~     Recurrent urinary tract infections (UTI) are a problem for postmenopausal women. The aim of~     this trial is to evaluate the effectiveness of lactobacilli in combination with low dose~     estriol for preventing recurrent urinary tract infections in postmenopausal women.~   "
203337|NCT00900640|"~     The aim of this study is to prospectively document the incidence of CM adverse reactions at~     the time of ERCP and to determine whether various perceived risk factors are predictive of~     adverse reaction.~      Adverse reactions to iodine containing contrast media (CM) have been described after~     endoscopic retrograde cholangiopancreaticography (ERCP) but have been difficult to study due~     to their extremely low incidence. Adverse reactions can be classified by severity (mild,~     moderate or severe) or underlying mechanism (idiosyncratic versus nonidiosyncratic).~     Nonidiosyncratic reactions are related to the dose and osmolality of the CM; these are not~     observed during ERCP due to the relative small amount of systemic absorption of CM.~     Idiosyncratic reactions on the other hand are not dose-dependent and generally occur shortly~     after administration of CM.~      Premedication with corticosteroids, H1/H2 -blockers and the use of low osmolality CM is~     beneficial in preventing nonidiosyncratic reactions during intravascular administration.~     However their role in during ERCP is unclear as CM is not injected into the intravascular~     space. Currently there are no formal recommendations and clinical practice varies~     considerably. The general purpose of this study is to determine the incidence of CM reactions~     during ERCP and to determine whether various risk factors are predictive of idiosyncratic~     reactions. Based on these results, we hope to develop guidelines for the use of prophylaxis~     to prevent CM reactions in ERCP.~   "
203338|NCT00900627|"~     The main purpose of this study is to determine if AZD8931 can improve the efficacy of~     standard chemotherapy for the treatment of advanced breast cancer. This study will be~     conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be~     safely administered with paclitaxel chemotherapy. The second part (phase II) will determine~     the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast~     cancer.~   "
203339|NCT00900614|"~     The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV)~     APR-246 when given to patients with refractory hematologic malignancies or prostate~     carcinoma.~   "
203340|NCT00900601|"~     Pelvic girdle pain (PGP) related to pregnancy is a common reason to sick leave during~     pregnancy. Low back pain and PGP affects about 50% of women during pregnancy. Most of the~     women recover, however about 10% of the women still have complaints after birth. Most~     patients have positive effect from conservative treatment, but unfortunately some do still~     have much pain despite intensive conservative rehabilitation. Surgery has been tried on these~     women with various results. Surgical treatment is controversial and there is a lack of~     documentation. The investigators will operate 20 patients with arthrodesis to the sacroiliac~     joint and symphysis. Radiostereometric analysis (RSA) will be used to evaluate the joint~     movement in different part of the process.~      Hypothesis: Severe pelvic girdle pain is caused by pelvic joint instability in some cases and~     surgically fixation of the affected joints can help these women to get back to a normal life.~   "
203341|NCT00900588|"~     A single center, stratified, randomized and double-blind phase II clinical trial was~     conducted in adolescents to evaluate the safety and immunogenicity of a split-virion pandemic~     influenza A vaccine (H5N1).~   "
203342|NCT00900575|"~     The objective of the work described in this protocol is to determine the optical signatures~     of cervical dysplasia using optical technologies.~   "
203343|NCT00900562|"~     This study is a phase II clinical and pharmacokinetic trial of PM00104 (Zalypsis®) in~     patients with advanced and/or metastatic endometrial or cervical cancer previously treated~     with one line of systemic chemotherapy to evaluate the antitumor activity and to determine~     the safety profile, the pharmacokinetic profile and the pharmacogenomic profile.~   "
203344|NCT00900549|"~     Heart failure is a major health problem in Canada. Recent advances in medical and device~     therapy have helped to reduce the morbidity and mortality of patients with this problem.~     Among these treatments, cardiac resynchronization therapy (CRT) has very recently been shown~     to be effective to improve functional class, quality of life and exercise tolerance of the~     patients with the most severe symptoms of heart failure and a prolonged duration of the QRS~     on the 12-lead Electrocardiography (ECG).~   "
203345|NCT00900536|"~     RATIONALE: Studying samples of blood and/or tissue in the laboratory from patients with~     kidney cancer receiving sorafenib may help doctors learn more about changes that occur in DNA~     and identify biomarkers related to cancer. It may also help doctors predict how well patients~     will respond to sorafenib.~      PURPOSE: This research study is looking at the DNA in blood and/or tissue samples from~     patients with primary kidney cancer receiving sorafenib on clinical trial MRC-RE05-SORCE.~   "
203346|NCT00900523|"~     RATIONALE: Measuring the amount of prostaglandin metabolite in urine samples and studying~     tissue samples in the laboratory from patients with ovarian cancer may help doctors identify~     and learn more about biomarkers related to ovarian cancer and may help the study of cancer in~     the future.~      PURPOSE: This laboratory study is measuring the amount of prostaglandin metabolite in urine~     samples from patients with ovarian cancer.~   "
203347|NCT00900510|"~     Background: Skin abscesses are a growing problem in the general pediatric population around~     the world. While the standard treatment for an abscess/boil is incision and drainage, many~     physicians also prescribe antibiotics, despite the lack of evidence that antibiotics are~     necessary to help the wound heal. The purpose of this research study is to determine whether~     antibiotics are necessary after incision and drainage of a skin abscess in children. This is~     an important question because medical evidence has shown that using antibiotics when they are~     not needed has contributed to the increase of bacterial antibiotic resistance. In fact,~     several of the antibiotics that successfully killed Staph bacteria several years ago are now~     no longer effective because of antibiotic resistance. Now resistant forms of Staph bacteria,~     called Community-Acquired Methicillin-Resistant Staph Aureus (CA-MRSA), account for 50-85%~     of all pediatric skin abscesses. If antibiotics are not necessary then withholding them when~     appropriate may help slow the progression of antibiotic-resistant Staph infections.~      Objective(s) and Hypothesis(es): The investigators believe that antibiotics are no better~     than placebo at achieving a cure after drainage of an abscess in a child. The objective of~     this study is to answer the question: Do antibiotics after abscess drainage result in a~     better chance of cure than placebo?~      Potential Impact: If abscess drainage alone is shown to be as effective as drainage followed~     by antibiotics, then the routine use of antibiotics for this problem could be avoided. This~     would help limit the increasing antibiotic resistance of bacteria (especially CA-MRSA) in~     communities around the world. A well-designed study may provide the evidence to change the~     way children are treated for abscesses in a future where antibiotic resistant bacteria will~     be even more of a public health challenge.~   "
203348|NCT00900497|"~     Background & Rationale:~      About 75% of US population living today will not die of cancer. There has been a recent~     report of a colony of cancer-resistant mice developed from a single male mouse that~     unexpectedly survived challenges of lethal cancer cell injections. In these so-called~     spontaneous regression/complete resistant (SR/CR) mice, cancer cells are killed by rapid~     infiltration of leukocytes, mainly of innate immunity. This highly effective natural cancer~     immunity is inherited and mediated entirely by white blood cells. Moreover, this cancer~     resistance can be transferred to wild type mice through the transfer of various immune cell~     types including granulocytes. The infusion of white blood cells, particularly cells of innate~     immunity, is a viable anticancer therapy in humans as well. This proposed trial will test~     whether white blood cell infusions from healthy unrelated donors can be used to treat cancer.~     The trial is designed to determine whether responses can be seen in cancer patients after~     infusion of HLA-mismatched white cells from healthy donors. It is important that the donors~     and recipients be unrelated and HLA-mismatched to avoid the possibility of~     transfusion-related Graft vs. Host Disease. The white blood cells from the healthy donors are~     being collected via apheresis following granulocyte mobilization with dexamethasone and~     filgrastim. The investigators will refer to the white blood cells as 'granulocytes' because~     75-90% of the white blood cells collected through the apheresis will consist of granulocytes.~     The dose of at least 2x10 to the11th will be given from 4-5 donors at a rate of no more than~     one donor per day for each recipient. There will only be one infusion per day and no more~     than 5 infusions per week. Thus, a typical treatment in the study would span 1-2 weeks. After~     each infusion, the patients will be monitored carefully for possible adverse events. If~     adverse events occur at any time point during or after individual infusion, the treatment can~     be stopped until the adverse events can be managed. The daily dose of each infusion is a~     frequently used level that has a long safety record. The trial will observe the subject's~     cancer for 3 months after the granulocyte infusions are completed. Response at 90 days will~     be based on comparison of tumor measurements at baseline. The trial has 3 major endpoints:~     dose response and tolerance, safety, and efficacy.~   "
203349|NCT00900484|"~     RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the~     laboratory may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer. It may also help doctors learn how patients respond to~     treatment.~      PURPOSE: This laboratory study is collecting, analyzing, and storing tissue samples from~     patients with non-Hodgkin's lymphoma.~   "
203350|NCT00900471|"~     RATIONALE: Collecting and storing samples of tissue or blood from patients with cancer for~     study in the laboratory may help the study of cancer in the future~      PURPOSE: This research study is collecting and storing blood and tissue samples from patients~     with suspected solid tumors.~   "
203351|NCT00900458|"~     Primary objective:~        -  To investigate whether physical exercise prior to pregnancy in formerly preeclamptic~          women results in a comparable improvement of vascular and endothelial functioning as in~          women who had an uneventful pregnancy.~      Secondary objectives:~        -  Which cardiovascular and endothelial parameters are involved in the vascular adaptation~          to training in women with a history of preeclampsia.~        -  To study the vascular adaptation in the (next) pregnancy in women with a history of~          preeclampsia compared with women with a history of an uncomplicated pregnancy, after~          improvement of their physical condition by exercise training.~      This study is important in order to get a better understanding of the vascular and~     endothelial factors involved in preeclampsia and the effects of training on this profile.~     Results of this study can contribute to the improvement of preventing hypertensive~     complications in pregnancy and reduction of life time risk of cardiovascular disease in~     formerly preeclamptic women.~   "
203352|NCT00900445|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about the affect of body mass index on the way anticancer drugs work in~     the body. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This clinical trial is studying body mass index in younger patients receiving~     prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute~     lymphoblastic leukemia.~   "
203353|NCT00900432|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that may occur in the immune system that may help kill~     cancer cells.~      PURPOSE: This laboratory study is looking at anticancer immune responses in the peripheral~     blood of patients with colon cancer.~   "
203354|NCT00900419|"~     RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with~     dysplasia or cancer and from normal volunteers may help doctors identify and learn more about~     biomarkers related to cancer. It may also help the study of cancer in the future.~      PURPOSE: This laboratory study is looking at biomarkers in patients with respiratory tract~     dysplasia or lung cancer, head and neck cancer, or aerodigestive tract cancer and in normal~     volunteers.~   "
203355|NCT00900406|"~     RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients~     undergoing a donor stem cell transplant to test in the laboratory may help the study of~     graft-versus-host disease in the future.~      PURPOSE: This research study is collecting and storing tissue and DNA samples from patients~     undergoing a donor stem cell transplant.~   "
203356|NCT00900380|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about cancer and the development of drug resistance in patients.~      PURPOSE: This laboratory study is examining tissue samples from patients with acute myeloid~     leukemia to learn more about drug resistance in these patients.~   "
203372|NCT00900159|"~     The purpose of this study is to test the effects of eszopiclone on daytime sleep and~     overnight wakefulness in shift workers.~   "
203357|NCT00900367|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about nutrition-related changes that identify biomarkers related to~     cancer. It may also help doctors predict a woman's risk of developing breast cancer.~      PURPOSE: This laboratory study is looking at nutrition-related biomarkers in predicting~     breast cancer risk in women.~   "
203358|NCT00900354|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving~     dactinomycin may help doctors learn how dactinomycin works in the body and how patients will~     respond to treatment.~      PURPOSE: This laboratory study is evaluating the pharmacokinetics of dactinomycin in young~     patients with cancer.~   "
203359|NCT00900341|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at tumor tissue samples from patients with soft~     tissue sarcoma.~   "
203360|NCT00900328|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This laboratory study is looking at tumor samples from patients with lung cancer.~   "
203361|NCT00900302|"~     RATIONALE: Studying protein expression in sentinel lymph node tissue from patients with~     cancer in the laboratory may help doctors identify and learn more about biomarkers related to~     cancer. It may also help the study of cancer in the future.~      PURPOSE: This laboratory study is evaluating OX-40 protein expression in the sentinel lymph~     nodes of patients with cancer.~   "
203362|NCT00900289|"~     RATIONALE: Studying tissue and blood samples from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients respond to treatment.~      PURPOSE: This laboratory study is evaluating DNA to see how well it predicts response to~     treatment in patients with stage I, stage II, stage III, or stage IV ovarian epithelial~     cancer.~   "
203363|NCT00900276|"~     RATIONALE: Studying samples of blood and urine from patients with cancer and from healthy~     participants in the laboratory may help doctors identify and learn more about biomarkers~     related to cancer.~      PURPOSE: This laboratory study is looking at biomarkers in patients with kidney cancer or~     cancer of the urothelium and in healthy participants.~   "
203364|NCT00900263|"~     RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with~     monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     these diseases. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at blood and bone marrow samples from patients with~     monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma.~   "
203365|NCT00900250|"~     This laboratory study is collecting and storing samples of tissue and blood from young~     patients with Hodgkin's lymphoma. Collecting and storing samples of tumor tissue and blood~     from patients with cancer to study in the laboratory may help the study of cancer in the~     future.~   "
203366|NCT00900237|"~     This purpose of this study is to measure the concentrations of two anti-epileptic drugs~     (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid~     and blood plasma of healthy subjects and also to assess how these drugs are tolerated.~   "
203367|NCT00900224|"~     RATIONALE: Studying samples of tissue and blood from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research study is looking at tissue and blood samples from patients with acute~     myeloid leukemia.~   "
203368|NCT00900211|"~     RATIONALE: Collecting and storing samples of tumor tissue from patients with soft tissue~     sarcoma to test in the laboratory may help the study of cancer in the future.~      PURPOSE: This laboratory is collecting tissue samples from patients with soft tissue sarcoma~     of the arms, hands, legs, or feet treated on clinical trial CRUK-VORTEX.~   "
203369|NCT00900198|"~     Background:~      -Patients who are being evaluated and/or treated at the NIH Clinical Center (pediatric and~     adult) and adult patients at participating sites will be entered onto this tissue procurement~     protocol for collection of tissue specimens.~      Objectives:~        -  To obtain samples from adult and pediatric patients for research purposes from tests and~          procedures that are done as required by the primary research protocol(s) to which a~          patient is enrolled or as part of their standard-of-care treatment.~        -  To obtain samples for research purposes from non-surgical procedures, such as~          percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or~          biological fluids for this protocol.~      Eligibility:~      -Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of~     age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center and~     adult patients from participating sites.~      Design:~        -  This is a multicenter tissue procurement protocol with NCI as the coordinating center.~        -  For adult patients: specimens for research purposes, as outlined in this protocol, will~          be obtained from tests and procedures that are done as required by the primary research~          protocols to which a patient is enrolled or as part of their standard-of-care treatment.~          Non-surgical procedures, such as percutaneous biopsies, may also be performed for the~          sole purpose of obtaining tissue specimens or biological fluids for this protocol.~          Tissues and biological fluids to be procured may include but are not limited to blood,~          serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial~          alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These~          specimens will be stored with unique identifiers and used to perform only those research~          studies that are outlined in this protocol.~        -  For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical~          model development will only be from tissue already being obtained as part of a procedure~          necessary for the patient s clinical care or as part of a primary research protocol;~          blood specimens will be collected as part of a blood collection already scheduled for~          the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes~          collected will not exceed institutional research limits.~        -  Given the risks associated with any invasive procedure, such as tumor biopsy, the~          procedure will be discussed in detail with the patients and their parents/guardian (as~          indicated), including the side effects, prior to obtaining a separate consent for each~          procedure. A separate consent will not be signed prior to obtaining samples by minimally~          invasive measures, such as venipuncture.~        -  This study has three separate consent forms: one for adult patients at the NIH Clinical~          Center to opt to donate their samples for ongoing research on assay development and~          studies of molecular pathways; and two for the generation of preclinical models (adult~          and pediatric). Adult patients at the NIH and participating sites, and also pediatric~          patients (NIH Clinical Center only), can opt to donate samples to create preclinical~          models to study tumor biology and genetics, and to develop new therapies for cancer.~        -  Patients may remain on study for the duration of their consent or completion of the~          planned procedure, whichever comes first.~   "
203370|NCT00900185|"~     RATIONALE: Studying samples of blood from patients with cancer and from healthy participants~     in the laboratory may help doctors learn more about changes that may occur in DNA.~      PURPOSE: This laboratory study is looking at blood samples from patients with prostate cancer~     and from healthy participants to identify a polymorphism that may help in the study of~     prostate cancer.~   "
203371|NCT00900172|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at blood and tissue samples from patients with~     locally advanced, metastatic, or recurrent non-small cell lung cancer treated with~     bevacizumab, carboplatin, and paclitaxel.~   "
203373|NCT00900146|"~     This was a four month dose ranging study followed by a 24 to 48 month extension at the~     selected dose to characterize the safety and efficacy of the injectable IL-1B (interleukin 1,~     beta) antagonist canakinumab in the treatment of patients with Type 2 diabetes mellitus~     (T2DM) already treated on maximum dose metformin.~   "
203374|NCT00900133|"~     RATIONALE: Measuring levels of calgranulin A and calgranulin B in the blood of patients with~     breast cancer in the laboratory may help doctors identify and learn more about biomarkers~     related to breast cancer.~      PURPOSE: This laboratory study is measuring calgranulin A and calgranulin B levels in the~     blood of patients with newly diagnosed stage I, stage II, or stage III breast cancer.~   "
203375|NCT00900120|"~     RATIONALE: Collecting and storing samples of blood from patients with cancer to test in the~     laboratory may help the study of cancer in the future.~      PURPOSE: This research study is collecting and storing blood samples from patients with~     cancer.~   "
203376|NCT00900107|"~     Only few data are available on the influence of strenuous exercise on the content of~     circulating progenitor cells and especially the timeframe of their release. The aim of the~     present study was to investigate the potential influence of 4 hours of cycling on the~     time-dependent release of progenitor cells.~   "
203377|NCT00900094|"~     RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with~     cancer and blood from healthy participants may help doctors learn more about changes that may~     occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at cancer-related protein biomarkers in the blood~     and tumor tissue of patients with cancer and in the blood of healthy participants.~   "
203378|NCT00900081|"~     RATIONALE: Studying samples of tissue from patients with or without cancer in the laboratory~     may help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at cyclooxygenase-2 expression in tissue samples~     from patients with a normal cervix, cervical intraepithelial neoplasia, or early invasive~     cervical cancer.~   "
203379|NCT00900068|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help~     doctors learn more about nausea and vomiting caused by cancer treatment.~      PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were~     treated on a clinical trial to control nausea and vomiting during donor stem cell transplant.~   "
203380|NCT00900055|"~     RATIONALE: Analyzing tissue and blood samples from healthy volunteers or patients with~     Fanconi anemia, myelodysplasia, myeloproliferative disorders, or myeloma in the laboratory~     may help doctors learn more about the causes of blood cancers.~      PURPOSE: The purpose of this study is to analyze in the laboratory blood and bone marrow~     cells from healthy volunteers or patients with Fanconi anemia, myeloproliferative disorders,~     or myeloma.~   "
203381|NCT00900042|"~     RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will~     respond to treatment.~      PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with~     metastatic kidney cancer.~   "
203382|NCT00900029|"~     This is a 24-week observational follow safety study for Study 802-247-09-015.~   "
203383|NCT00900016|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is assessing fibroblast activity in patients with localized~     pancreatic cancer undergoing surgery.~   "
203384|NCT00900003|"~     RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in patients with pancreatic cancer.~   "
203385|NCT00899990|"~     This research study is collecting and storing samples of tumor tissue, bone marrow, and blood~     from patients with Ewing sarcoma. Collecting and storing samples of tumor tissue, bone~     marrow, and blood from patients with cancer to test in the laboratory may help the study of~     cancer in the future.~   "
203386|NCT00899977|"~     A pilot study of subjects with refractory hypertension (on 3 concomitant agents with SBP >~     140 mmHg and a DBP > 90 mmHg) randomized in a double-blind fashion to receive 4 single~     escalating doses of study medication in clinic.~   "
203387|NCT00899964|"~     Though possibly cost-saving, there is little scientific evidence for the effectiveness and~     reasonable modality of internet-delivered physical activity interventions in primary~     prevention. The aim of the study is to compare the influence of different personal and~     IT-based service levels on the activity outcome of obese, sedentary persons to evaluate the~     minimum level of service necessary for a maximum increase in activity and weight reduction.~   "
203388|NCT00899951|"~     RATIONALE: Studying blood samples from cancer patients undergoing pain treatment in the~     laboratory may help doctors learn more about how pain drugs work in the body. It may also~     help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at fentanyl in patients with cancer.~   "
203389|NCT00899912|"~     RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the~     laboratory may help doctors learn more about changes that may occur in DNA after radiation~     therapy and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at changes in DNA after radiation therapy in~     patients with prostate cancer.~   "
203390|NCT00899899|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about cancer and the development of drug resistance in patients.~      PURPOSE: This laboratory study is looking at resistance to methotrexate in patients with~     acute lymphoblastic leukemia in relapse or remission.~   "
203391|NCT00899873|"~     RATIONALE: Studying samples of cells in the laboratory from patients with cancer may help~     identify biomarkers related to cancer. It may also help doctors learn how patients respond to~     treatment.~      PURPOSE: This laboratory study is analyzing samples of cells from patients with chronic~     lymphocytic leukemia who were treated on clinical trial ECOG-2997.~   "
203392|NCT00899860|"~     RATIONALE: Studying the genes and proteins expressed in tissue samples from patients with~     cancer may help doctors identify biomarkers related to cancer.~      PURPOSE: This laboratory study is evaluating gene and protein expression in normal tissue and~     tumor tissue from patients who have undergone surgery for kidney cancer.~   "
203394|NCT00899834|"~     This multi-institutional study will prospectively collect tumor and constitutional tissue~     samples from patients with diffuse brainstem glioma and other types of brainstem gliomas~     either during therapy or at autopsy to perform an extensive analysis of genetic and molecular~     abnormalities in these tumors.~   "
203395|NCT00899821|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about how interleukin-2, interleukin-12, and GM-CSF delivered in~     microspheres increase the body's ability to kill tumor cells.~      PURPOSE: This laboratory study is looking at microsphere-delivered cytokines to see if they~     increase tumor response in lymphocytes from patients with head and neck cancer.~   "
203396|NCT00899808|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at molecular markers and genetic markers in patients~     undergoing radiation therapy for cancer.~   "
203397|NCT00899795|"~     RATIONALE: Studying samples of bone marrow from patients with cancer and from healthy~     volunteers in the laboratory may help doctors learn more about changes that occur in bone~     marrow stromal (connective tissue) cells. It may also help doctors understand the effects of~     alkylating agents on bone marrow stromal cells.~      PURPOSE: This laboratory study is evaluating stromal cells in patients with acute myeloid~     leukemia, myelodysplastic syndromes, or Fanconi anemia; in patients who were exposed to~     alkylating agents; and in healthy volunteers.~   "
203398|NCT00899782|"~     This research studies collecting and storing tissue and blood samples from patients with lung~     cancer who are undergoing surgery. Collecting and storing samples of tissue and blood from~     patients with lung cancer to study in the laboratory may help doctors learn more about~     changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to~     cancer.~   "
203399|NCT00899769|"~     RATIONALE: Studying samples of blood, tissue, and saliva in the laboratory from patients with~     cancer and from healthy volunteers may help doctors identify and learn more about biomarkers~     related to cancer.~      PURPOSE: This laboratory study is looking at biomarkers in patients with head and neck cancer~     and in healthy volunteers.~   "
203400|NCT00899756|"~     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the~     laboratory may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations in~     the blood of patients with advanced non-small cell lung cancer.~   "
203401|NCT00899743|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is looking at blood and bone marrow samples from patients with~     previously untreated primary acute myeloid leukemia.~   "
203402|NCT00899717|"~     The purpose of this study is to determine whether occlusal adjustment by selective grinding~     and/or occlusal addition is an effective treatment of chronic temporomandibular joint~     disorders.~   "
203403|NCT00899704|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at tissue samples in predicting oral cancer in~     patients who have undergone neck dissection for oral cancer.~   "
203404|NCT00899691|"~     RATIONALE: Studying samples of hair in the laboratory from patients with cancer may help~     doctors identify biomarkers related to cancer and predict how well patients will respond to~     treatment.~      PURPOSE: This laboratory study is looking at hair samples from patients with cancer.~   "
203405|NCT00899678|"~     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and~     immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with~     moderately to severely active Crohn's disease. The target enrollment is 160 subjects.~   "
203406|NCT00899665|"~     RATIONALE: Collecting and storing samples of bone marrow and tissue from patients to test in~     the laboratory may help the study of cancer.~      PURPOSE: This laboratory study is comparing proteases (enzymes that break down protein) in~     patients with prostate cancer that has spread to the bone with patients who do not have~     cancer that has spread to the bone.~   "
203407|NCT00899652|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at DNA in bone marrow and blood samples from young~     patients with acute myeloid leukemia or acute lymphoblastic leukemia.~   "
203408|NCT00899639|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at tumor tissue samples from patients with~     early-stage breast cancer.~   "
203409|NCT00899626|"~     RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from~     patients with cancer and from healthy participants may help doctors identify and learn more~     about biomarkers related to cancer.~      PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and~     biological fluid samples from patients and healthy participants undergoing colonoscopy,~     endoscopy, or surgery.~   "
203410|NCT00899613|"~     RATIONALE: Studying levels of mesothelin and osteopontin in samples of blood from patients~     with mesothelioma or atypical mesothelial hyperplasia may help doctors identify biomarkers~     related to cancer.~      PURPOSE: This research study is looking at mesothelin and osteopontin as diagnostic markers~     in patients with mesothelioma or atypical hyperplasia.~   "
203425|NCT00899405|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at tumor tissue samples and blood samples to learn~     more about DNA changes in patients with lung cancer.~   "
203443|NCT00899132|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is evaluating a tumor marker for testicular cancer, skin cancer,~     small intestine cancer, and pancreatic cancer.~   "
203411|NCT00899600|"~     Noxious stimuli occurring intraoperatively and postoperatively generate central~     sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements.~     The pathophysiology of central sensitization is thought to involve excitatory amino acid~     receptors such as N-methyl-d-aspartate (NMDA) (1, 2). Ketamine is a N-methyl-d-aspartate~     (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute~     postoperative pain and analgesic consumption in a variety of surgical interventions (3).~      Spine surgery provides a unique opportunity to evaluate the preemptive and preventative~     impact of ketamine on the primary end points of postoperative 24 and 48 hour opioid~     consumption in patients with chronic pain. The goal of this IRB approved double blinded,~     prospective, randomized placebo controlled trial is to quantify the preemptive and~     preventative analgesic effects of ketamine infusions in this patient population. Such insight~     may lead to better pain control, improved satisfaction, and ultimately a reduction in~     side-effects related to postoperative opioid use.~   "
203412|NCT00899587|"~     In this study, patients were divided into 3 group with 35 cases including: 1.oxygen~     2.enalapril 3.control.~      In the beginning of the study, best corrected visual acuity (BCVA), uncorrected visual acuity~     (UCVA), and optical coherence tomography (OCT) were measured. Patients in the oxygen group~     were given oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second~     month and every other day at the third month. In the enalapril group, patients were given~     enalapril 5 mg every night and placebo was given for the patients in third group. At the end~     of first month the patients' vision was checked again and at the the end of the third month~     the first physical examinations were performed. In the first group, arterial blood gas (ABG)~     was taken before and after oxygen therapy as well.~   "
203413|NCT00899574|"~     The purpose of this trial is to determine the safety and efficacy of Imiquimod, a Toll-like~     receptor 7 agonist in breast cancer (for chestwall recurrences or metastases to the skin).~   "
203414|NCT00899561|"~     In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology.~     Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant~     histopathologic changes in the middle turbinate mucosa of patients with chronic~     rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score~     was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of~     1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No~     osteomyelitic changes were seen in this study group.~      The investigators hypothesize that a comparison between the three groups of patients with~     chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show~     that the higher the CT staging, the greater the histopathologic changes of the middle~     turbinate. The investigators also expect to find osteomyelitic changes in the middle~     turbinate of patients with higher CT staging.~   "
203415|NCT00899548|"~     RATIONALE: Studying samples of blood from patients with cancer and from healthy participants~     in the laboratory may help doctors learn more about changes that may occur in DNA and~     identify biomarkers related to cancer. It may also help doctors predict how well patients~     will respond to systemic therapy.~      PURPOSE: This laboratory study is looking at DNA in predicting response after systemic~     therapy in women with metastatic breast cancer.~   "
203416|NCT00899535|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at the cancer genome using tumor samples from~     patients with stage I or stage II non-small cell lung cancer treated on clinical trial~     ACOSOG-Z0030.~   "
203417|NCT00899522|"~     RATIONALE: Collecting and storing samples of tumor tissue from patients with Fanconi anemia~     to test in the laboratory may help the study of cancer in the future.~      PURPOSE: This laboratory study is collecting and storing tumor tissue samples from patients~     with Fanconi anemia.~   "
203418|NCT00899509|"~     This research trial studies deoxyribonucleic acid (DNA) in tumor tissue from women with~     node-positive breast cancer to see if genetic factors are related to the patient's response~     to chemotherapy. DNA analysis of tumor tissue may help doctors predict how well patients will~     respond to treatment with certain chemotherapy drugs.~   "
203419|NCT00899496|"~     RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer~     and from healthy participants may help doctors learn more about cancer.~      PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in~     patients with metastatic cancer and in healthy participants.~   "
203420|NCT00899483|"~     The investigators have previously demonstrated that the administration of insulin in the form~     of an infusion with additional sugar and potassium may improve cardiovascular performance and~     reduce biochemical evidence of heart muscle injury in non-diabetic patients undergoing~     coronary artery surgery. The investigators now seek to demonstrate that similar benefits can~     be achieved in diabetic patients by administering insulin to maintain as near absolutely~     normal sugar levels as possible.~   "
203421|NCT00899470|"~     To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate~     release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg~     metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.~   "
203422|NCT00899457|"~     RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from~     healthy participants in the laboratory may help doctors learn more about changes that occur~     in DNA and identify biomarkers related to cancer. It may also help doctors learn more about~     the development of cancer.~      PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer~     development using tissue samples from healthy participants.~   "
203423|NCT00899431|"~     The goal of this clinical research study is to learn if lenalidomide, when given with a stem~     cell transplant and chemotherapy (bendamustine, fludarabine, and rituximab), can help to~     control CLL. The safety of this treatment combination will also be studied.~   "
203424|NCT00899418|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors understand how well patients respond to treatment.~      PURPOSE: This laboratory study is examining tumor tissue samples from patients with breast~     cancer treated with bevacizumab on clinical trial ECOG-2100 to learn more about DNA changes~     and response in these patients.~   "
203426|NCT00899392|"~     Informed consent/assent in pediatric medicine is an accepted and important practice that has~     been rarely studied, tested for quality, or optimized for patient satisfaction. In the~     pursuit of enhancing and studying pediatric care, the investigators propose, as pediatric~     gastroenterologists, assessing the current state of parental and adolescent consent/assent in~     upper gastrointestinal endoscopy and offering a computer based education program to improve~     it. The investigators will look at outcomes that include anxiety, satisfaction, attainment of~     informed consent, and patient flow efficiency in a GI endoscopy suite.~   "
203427|NCT00899379|"~     A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine~     compared to placebo.~   "
203428|NCT00899366|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at tissue samples from patients with T-cell acute~     lymphoblastic leukemia.~   "
203429|NCT00899353|"~     Escalating doses of Omega 3 Fatty Acids are being used in patients who have early stage~     Chronic Lymphocytic Leukemia (ES-CLL), Monoclonal Gammopathy of Undetermined Significance~     (MGUS), or Smoldering Multiple Myeloma (SMM), whose disease does not currently require~     treatment. The primary aim of the study is to determine if the Omega 3 supplementation will~     help prevent or delay progression of the disease to a stage that requires treatment.~   "
203430|NCT00899340|"~     RATIONALE: Studying the proteins expressed in samples of tumor tissue from patients with~     cancer may help doctors identify and learn more about biomarkers related to cancer. It may~     also help doctors plan better treatment for patients with cancer of the oropharynx.~      PURPOSE: This laboratory study is looking at protein expression in tumor tissue samples from~     patients with cancer of the oropharynx.~   "
203431|NCT00899327|"~     RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients at risk~     of developing myelodysplastic syndrome may help doctors learn more about changes that occur~     in DNA and identify biomarkers related to disorders of the blood and bone marrow.~      PURPOSE: This research study is looking at biomarkers in patients at risk of developing~     myelodysplastic syndrome or other disorders and in healthy participants.~   "
203432|NCT00899301|"~     RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with or~     without breast cancer to study in the laboratory may help the study of cancer.~      PURPOSE: This research study is collecting and storing tissue samples from women with or~     without breast cancer.~   "
203433|NCT00899288|"~     RATIONALE: Studying samples of fingernails in the laboratory from patients with breast cancer~     may help in evaluating bone health in postmenopausal women undergoing hormone therapy for~     breast cancer.~      PURPOSE: This laboratory study is examining fingernails as a way of evaluating bone health in~     postmenopausal women with breast cancer undergoing hormone therapy on clinical trial~     IBCSG-1-98.~   "
203434|NCT00899275|"~     RATIONALE: Collecting and storing samples of tumor tissue and blood from patients to test in~     the laboratory may help the study of cancer in the future.~      PURPOSE: The purpose of this study is to collect and store samples of blood and tumor tissue~     from patients with osteosarcoma.~   "
203435|NCT00899262|"~     RATIONALE: Collecting and storing samples of sputum and tissue to study in the laboratory may~     help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking samples of sputum and tissue from lung cancer~     patients, participants at high risk for developing lung cancer, and from healthy volunteers~     (both smokers and non-smokers).~   "
203436|NCT00899223|"~     As one of the nation's largest cooperative cancer treatment groups, the Alliance for Clinical~     Trials in Oncology (Alliance) is in a unique position to organize a Leukemia Tissue Bank. The~     member institutions diagnose hundreds of patients with leukemia or myelodysplastic syndrome~     each year, and uniformly treat these patients with chemotherapy regimens. The Alliance offers~     centralized data management for the clinical history, the classification of the leukemia and~     myelodysplastic syndrome, cytogenetics, flow cytometric analysis, treatment and follow-up.~     The highly skilled health care providers at each member institution are familiar with~     obtaining informed consent, completing data questionnaires and shipping specimens. There~     currently exists a central processing facility where samples are prepared for a variety of~     cellular and molecular studies. Hence, the patient resources, the health care providers, and~     a processing facility for a Leukemia Tissue Bank are all in place. What is needed, however,~     and is addressed in the current protocol, is a formal mechanism to procure bone marrow, blood~     and normal tissue from patients with hematologic malignancies who are to be enrolled on~     Alliance (Cancer and Leukemia Group B [CALGB]) treatment studies.~   "
203437|NCT00899210|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research trial is studying matrix metalloproteinases after surgery or~     radiofrequency ablation in patients with liver metastases from colorectal cancer.~   "
203438|NCT00899197|"~     RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to tamoxifen resistance.~      PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I,~     stage II, stage IIIA, or stage IIIB breast cancer.~   "
203439|NCT00899184|"~     RATIONALE: Collecting and storing samples of blood from patients and their brothers with~     cancer to study in the laboratory may help doctors learn more about changes that may occur in~     DNA and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers~     with prostate cancer.~   "
203440|NCT00899171|"~     RATIONALE: Studying samples of bone marrow and blood in the laboratory from patients with~     cancer may help doctors learn more about changes that occur in DNA and identify biomarkers~     related to cancer.~      PURPOSE: This research study is looking at bone marrow and blood samples from patients with~     acute myeloid leukemia.~   "
203441|NCT00899158|"~     RATIONALE: Learning about biological markers in patients with pancreatic cancer and cachexia~     may help doctors predict patient outcome and may help the study of cancer in the future.~      PURPOSE: This laboratory study is examining biological markers in patients with pancreatic~     cancer experiencing weight loss.~   "
203444|NCT00899119|"~     RATIONALE: Collecting and storing stem cells to study in the laboratory may help doctors~     learn more about collecting stem cells from patients who have undergone treatment for~     Waldenstrom's macroglobulinemia.~      PURPOSE: This laboratory study is collecting stem cells from patients with Waldenstrom's~     macroglobulinemia.~   "
203445|NCT00899093|"~     This research trial studies chitinase 3-like 1 (cartilage glycoprotein-39) (YKL-40) in serum~     samples from patients with newly diagnosed stage III-IV ovarian epithelial, primary~     peritoneal cavity, or fallopian tube cancer receiving chemotherapy. Studying samples of serum~     in the laboratory from patients receiving chemotherapy may help doctors learn more about the~     effects of chemotherapy on cells. It may also help doctors understand how well patients~     respond to treatment.~   "
203446|NCT00899080|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at blood samples from patients with multiple myeloma~     who were treated with thalidomide or lenalidomide.~   "
203447|NCT00899054|"~     The purpose of this study is to identify a dose of P276-00 that can be safely administered~     along with Radiation and to examine safety and efficacy of the combination in treatment of~     advanced head and neck cancer.~   "
203448|NCT00899041|"~     The purpose of this study is to investigate whether subjects receiving a high-flexion knee~     prosthesis show a better knee function than patients receiving a standard knee prosthesis.~     Thigh-calf contact force measurements are used to quantify knee function. The investigators'~     hypothesis is that high-flexion knees show a better knee function.~   "
203449|NCT00899028|"~     RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung~     cancer and from healthy participants in the laboratory may help doctors learn more about~     changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples~     from patients with lung cancer and from healthy participants.~   "
203450|NCT00899015|"~     RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma~     treated with arsenic trioxide may help doctors learn more about cancer.~      PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent~     or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.~   "
203451|NCT00899002|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This laboratory study is looking at biomarkers in stored tumor samples from younger~     patients with liver cancer.~   "
203452|NCT00898989|"~     Comparison of a group of 20 IBM patients with 20 controls matched on age, gender and weight.~   "
203453|NCT00898976|"~     RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with~     breast cancer may help doctors identify and learn more about biomarkers related to breast~     cancer in these patients. It may also help doctors learn more about the prognosis of these~     patients.~      PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast~     cancer.~   "
203454|NCT00898963|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how patients respond to treatment.~      PURPOSE: This laboratory study is looking at biomarkers in patients with stage III or stage~     IV follicular lymphoma treated on clinical trial E-1496.~   "
203455|NCT00898950|"~     This study was set up to assess the effects of different doses of aspirin when compared with~     placebo (dummy drug), used sequentially over a 2 week study period with a 2 week wash-out~     (rest period) in between, in people with type-2 diabetes and high cardiovascular risk.~     Specifically, its effects on different factors which are thought to contribute to diabetes~     such as insulin resistance (body's ability to effectively use insulin), dysglycaemia (excess~     glucose in the blood), oxidative stress (effects from accumulation of by-products of~     metabolism), endothelial function (function of lining of blood vessels) and inflammation were~     studied.~   "
203456|NCT00898937|"~     RATIONALE: Studying samples of breast tissue in the laboratory may help doctors learn more~     about the genes and proteins found in breast tissue.~      PURPOSE: This phase I trial is studying genes and proteins in breast tissue from women~     undergoing surgery for breast cancer or core biopsy of the breast.~   "
203457|NCT00898924|"~     RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the~     laboratory may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations and~     k-ras oncogene mutations in patients with stage III non-small cell lung cancer.~   "
203458|NCT00898911|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at blood sample analysis in predicting overall~     survival in patients with recurrent or metastatic head and neck cancer.~   "
203459|NCT00898898|"~     This research study is looking at tissue samples from women with breast cancer who were~     treated on clinical trial NCCTG-N9831. Studying samples of tissue from patients with cancer~     in the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~   "
203475|NCT00898677|"~     A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine~     attacks and duration of relief provided. This study will also provide additional efficacy~     data on rizatriptan 5 mg and 10 mg for the treatment of migraine.~   "
203476|NCT00898664|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at DNA in tissue samples from patients with head~     and neck cancer.~   "
203547|NCT00897624|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer may help~     doctors find out the extent of disease.~      PURPOSE: This research study is collecting bone marrow and blood samples from patients with~     metastatic choroid melanoma.~   "
203460|NCT00898885|"~     Introduction: Graft-versus-host-disease (GVHD) is the major cause of morbidity and mortality~     in patients submitted to the Bone Marrow Transplantation (BMT). The oral manifestations can~     be very debilitating and interfere in the results of medical therapy, leading to systemic~     complications, committing the prognosis and quality of life of the patient.~      The early diagnosis can be done through biopsies of oral mucosa with or without apparent~     injury clinic. The association between the clinical and histopathological tables of GVHD,~     especially through the use of recent consensus established in these areas, can bring new~     benefits to physicians.~      Objective: This study aims to apply and compare the two classifications histological to GVHD,~     Horn (1995) and Consensus (2006) in specimens obtained from clinical oral lesions suggestive~     of GVHD; correlate them with clinical classification according Akpek (2001) and with the~     survival of the patients.~   "
203461|NCT00898872|"~     RATIONALE: Collecting and storing samples of tissue from patients with non-Hodgkin lymphoma~     to study in the laboratory may help the study of cancer in the future.~      PURPOSE: This laboratory study is collecting and storing tissue samples from patients with~     relapsed or recurrent non-Hodgkin lymphoma after treatment on a Southwest Oncology Group~     (SWOG) clinical trial.~   "
203462|NCT00898859|"~     Despite emerging implications for ADAMs (and matrix metalloproteinases (MMPs)) in disease~     progression, the mechanisms that lead to activation of specific ADAMs (and MMPs) and their~     actions in chronic obstructive pulmonary disease (COPD) are still incompletely understood. In~     the current study, the researchers aim to investigate the effects of cigarette smoke on~     cellular parameters that are relevant for development of COPD and the involvement of ADAM~     activity in these effects. By studying the effects of ADAM inhibition, the researchers aim to~     provide novel insights in the role of ADAMs in the development of COPD, which may offer new~     therapeutic targets for the treatment of COPD.~   "
203463|NCT00898846|"~     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict which patients will respond to treatment.~      PURPOSE: This laboratory study is looking at prognostic factors in patients receiving~     tegafur-uracil for stage II colon cancer that was completely removed by surgery.~   "
203464|NCT00898833|"~     RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory~     may help doctors identify and learn more about biomarkers related to cancer. It may also help~     doctors predict how patients will respond to treatment.~      PURPOSE: This laboratory study is measuring plasma and urine biomarkers in patients with~     advanced prostate cancer that did not respond to hormone therapy.~   "
203465|NCT00898820|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving pemetrexed~     disodium may help doctors learn more about the effects of pemetrexed disodium on cells. It~     may also help doctors understand how well patients respond to treatment.~      PURPOSE: This laboratory study is looking at blood samples from patients with stage III or~     stage IV non-small cell lung cancer enrolled in clinical trial MCCRC-RC0524 to determine the~     effect of pemetrexed disodium on cells.~   "
203466|NCT00898807|"~     The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation~     in Alzheimer's dementia.~   "
203467|NCT00898794|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about the effect of bevacizumab and VEGF on platelet clustering.~      PURPOSE: This research study is looking at the effect of bevacizumab and VEGF on platelet~     clustering in patients with cancer who are receiving bevacizumab.~   "
203468|NCT00898781|"~     RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients~     with metastatic cancer may help doctors find out how much the cancer has spread.~      PURPOSE: This research study is looking at the number of circulating cancer cells in patients~     with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.~   "
203469|NCT00898768|"~     Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is a hereditary~     disorder characterized by a very high risk of early-onset colorectal and endometrial cancer~     and an increased risk of other cancers, including cancers of the stomach, ovary, urinary~     tract, hepatobiliary tract, pancreas and small bowel. This is a national multi-centre study~     evaluating the yield of small bowel screening using capsule endoscopy (CE) and double balloon~     enteroscopy (DBE) in Lynch syndrome subjects. The intervention consists of performing a~     capsule endoscopy procedure at baseline and at 2-year follow-up. In patients with polyps or~     malignant appearing abnormalities on capsule endoscopy, double balloon enteroscopy will be~     performed with subsequent endoscopic or surgical removal of neoplastic lesions. The aim of~     the study is to determine the prevalence and incidence of small bowel neoplasia in Lynch~     syndrome patients using small bowel CE and DBE.~   "
203470|NCT00898755|"~     RATIONALE: Collecting and storing samples of tissue, blood, and bone marrow from patients~     with cancer to study in the laboratory may help doctors learn more about changes that may~     occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is collecting and storing tissue, blood, and bone marrow~     samples from young patients with cancer.~   "
203471|NCT00898742|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how will patients respond to treatment.~      PURPOSE: This research study is looking at gene and protein expression patterns in predicting~     response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.~   "
203472|NCT00898716|"~     The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807~     when administered orally on a once daily schedule in subjects with solid tumors.~   "
203473|NCT00898703|"~     RATIONALE: Studying samples of blood in the laboratory from patients with current or previous~     cancer may help doctors learn more about biomarkers related to cancer.~      PURPOSE: This research study is looking at blood samples in women with breast cancer or a~     history of breast cancer.~   "
203474|NCT00898690|"~     RATIONALE: DNA analysis of tumor tissue may help doctors predict how patients who receive~     paclitaxel will respond to treatment.~      PURPOSE: This laboratory study is evaluating gene expression in predicting response to~     paclitaxel in patients with breast cancer.~   "
213712|NCT00762554|"~     Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion~     of fentanyl for the first 48 hours after a cesarean section.~   "
203477|NCT00898638|"~     RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with~     cancer and from healthy participants to study in the laboratory may help the study of cancer~     in the future.~      PURPOSE: This research study is collecting and storing tissue samples from patients with head~     and neck cancer and from healthy participants.~   "
203478|NCT00898612|"~     RATIONALE: Studying samples of blood in the laboratory from patients who have undergone a~     donor bone marrow transplant may help doctors learn more about changes that occur in DNA and~     identify biomarkers related to graft-versus-host disease. It may also help doctors predict~     how patients will respond to a donor bone marrow transplant.~      PURPOSE: This laboratory study is looking at early detection of graft-versus-host disease in~     patients undergoing a donor bone marrow transplant.~   "
203479|NCT00898599|"~     Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They~     are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented~     by some species of intestinal bacteria. This fermentation is thought to have several benefits~     for the host including improving immune function. There are numerous methods available for~     assessing the human immune response. Response to vaccination is thought to be a good method~     for this. Not many studies have examined the effect of prebiotics on the human immune~     response to vaccination. Thus the investigators propose to test the effect of a prebiotic on~     the immune response in healthy volunteers including their response to the current flu~     vaccine. The investigators hypothesise that the prebiotic will enhance the immune response~     including the response to the vaccine.~   "
203480|NCT00898573|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about cancer and the development of drug resistance in~     patients.~      PURPOSE: This research study is looking at lapatinib resistance in patients with breast~     cancer.~   "
203481|NCT00898560|"~     The purpose of this study is to investigate whether multiple-dose administration of~     eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics~     and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and~     levonorgestrel).~   "
203482|NCT00898547|"~     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the~     laboratory may help doctors learn more about cancer and identify biomarkers related to~     cancer.~      PURPOSE: This laboratory study is looking at biomarkers of angiogenesis and disease in~     patients with unresectable malignant mesothelioma treated on clinical trial CALGB-30107.~   "
203483|NCT00898534|"~     Immediate feedback of hemoglobin A1c (A1c) results to adults with type 1 and 2 diabetes~     allows more appropriate care decisions at the clinic visit and may improve glycemic control.~     The investigators' objective is to determine whether immediate feedback of A1c results to~     children with type 1 diabetes will improve patient care and glycemic control.~   "
203484|NCT00898521|"~     Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is~     known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is~     the source of local and/or systemic infection or sepsis. The local inflammation and infection~     destroy healthy surrounding tissues and extends the original damage. In order to prevent~     these complications, and in order to minimize the risk of infection, it is imperative to~     evaluate the burn and remove all of the offending eschar at the earliest possible~     opportunity. This removal of dead tissue is termed debridement.~      The most direct debridement method for eschar removal is surgery. Traditional, conservative~     non-surgical debridement is a lengthy process which often involves many complications.~      The objectives of this study are as follows:~        1. To evaluate the safety and efficacy (exploratory) of DGD in hospitalized patients with~          Partial Thickness (mid and deep dermal) thermal burns of 4-30% total body surface area~          (TBSA), but with total burn wounds of no more than 30% TBSA. Measures have already been~          taken in previous studies involving deeper wounds to control safety parameters (such as~          pain, fever and infection). Nevertheless, as part of the effort to expand the burn~          population in the future phase 3 study to the more superficial wound group, it is~          important to first explore these parameters in a small group involving this burn~          population.~        2. To explore DGD absorption as measured by Pharmacokinetic testing.~   "
203485|NCT00898508|"~     RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer~     to test in the laboratory may help the study of cancer in the future.~      PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with~     invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast~     disease.~   "
203486|NCT00898495|"~     RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict a patient's response to treatment.~      PURPOSE: This laboratory study is looking at genes to see if they can predict outcome in~     patients with esophageal cancer treated with cisplatin, radiation therapy, and surgery.~   "
203487|NCT00898482|"~     RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy~     participants to test in the laboratory may help the study of cancer in the future.~      PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic~     cancer and healthy participants.~   "
203488|NCT00898469|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to bone~     tissue death.~      PURPOSE: This laboratory study is looking at risk factors for bone tissue death in young~     patients with acute lymphoblastic leukemia treated on clinical trial CCG-1882.~   "
203489|NCT00898456|"~     This research trial studies multidrug resistance genes in patients with acute myeloid~     leukemia. Studying samples of bone marrow or blood from patients with cancer in the~     laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid~     (DNA) and identify biomarkers related to cancer. It may also help doctors learn more about~     drug resistance and how patients respond to treatment.~   "
203490|NCT00898443|"~     This study is to study the success rate of using the epidural catheter that was placed during~     the labor for the surgical anesthesia to perform a postpartum tubal ligation.~   "
203543|NCT00897676|"~     The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood~     glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism. Funding~     Source - FDA Office of Orphan Products Development (OODP).~   "
203491|NCT00898430|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at biomarkers in predicting response to treatment in~     patients with newly diagnosed stage III or stage IV head and neck cancer treated with~     carboplatin, paclitaxel, and radiation therapy.~   "
203492|NCT00898417|"~     RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment for~     non-small cell lung cancer may help doctors predict how patients will respond to treatment.~      PURPOSE: This laboratory study is looking at proteomic patterns in stored blood samples from~     patients undergoing treatment for non-small cell lung cancer.~   "
203493|NCT00898404|"~     This laboratory study is looking at response or resistance to chemotherapy in young patients~     with acute lymphoblastic leukemia treated with methotrexate. Studying samples of tumor tissue~     in the laboratory from patients with cancer may help doctors learn more about changes that~     occur in DNA and drug resistance in patients.~   "
203494|NCT00898391|"~     This research trial studies is deoxyribonucleic acid (DNA) in blood samples from patients~     with neuroblastoma. Studying samples of blood from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~   "
203495|NCT00898378|"~     RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer,~     patients with colorectal polyps and from patients without polyps may help doctors learn more~     about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at biomarkers in blood and tissue samples from~     patients with colorectal cancer or colorectal polyps and from patients without polyps~     (healthy volunteers).~   "
203496|NCT00898365|"~     This research trial studies kidney tumors in younger patients. Collecting and storing samples~     of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may~     help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify~     biomarkers related to cancer.~   "
203497|NCT00898352|"~     RATIONALE: Patient abstract not available~      PURPOSE: Patient abstract not available~   "
203498|NCT00898326|"~     RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after~     receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may~     help doctors identify biomarkers related to cancer and help doctors predict how patients will~     respond to treatment.~      PURPOSE: This laboratory study is looking at PSA levels and biopsy samples after undergoing~     implant radiation therapy and luteinizing hormone-releasing hormone agonist therapy in~     patients with stage I or stage II prostate cancer.~   "
203499|NCT00898313|"~     RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk~     of cancer for laboratory studies may help doctors learn more about changes that may occur in~     DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at molecular predictors of cancer in patients at high~     risk of lung cancer.~   "
203500|NCT00898300|"~     RATIONALE: Collecting and storing samples of tissue, blood, and saliva from patients with~     cancer to study in the laboratory may help the study of cancer in the future.~      PURPOSE: This laboratory study is collecting and storing tissue samples from patients with~     head and neck cancer.~   "
203501|NCT00898287|"~     The purpose of this study is to identify a dose of P276-00 that can be safely administered~     along with Gemcitabine and to examine safety and efficacy of the combination in treatment of~     advanced pancreatic cancer.~   "
203502|NCT00898274|"~     RATIONALE: Studying samples of blood in the laboratory from patients who are at high risk of~     developing prostate cancer may help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at blood samples from patients at high risk of~     developing prostate cancer and from healthy male participants.~   "
203503|NCT00898261|"~     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer~     may help doctors identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at gene expression in tissue from patients with~     acute lymphoblastic leukemia enrolled in clinical trial ECOG-2993.~   "
203504|NCT00898235|"~     RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with~     amyloid diseases to test in the laboratory may help the study of this disease in the future.~      PURPOSE: This research study is collecting samples from patients with amyloid diseases~   "
203505|NCT00898222|"~     Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal~     subjects.~   "
203506|NCT00898209|"~     RATIONALE: Collecting and storing samples of blood and exhaled breath from patients with~     cancer and from healthy participants to study in the laboratory may help doctors learn more~     about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is collecting and analyzing samples of blood and exhaled breath~     from patients who have or are at high risk for lung cancer and from healthy participants.~   "
203507|NCT00898183|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This laboratory study is assessing genes and immune response in tumor samples from~     patients with locally advanced or metastatic melanoma.~   "
203508|NCT00898170|"~     The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter~     monitoring and erythropoetin level check.~   "
203509|NCT00898157|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     understand how patients respond to treatment.~      PURPOSE: This laboratory study is looking at biomarkers using tissue samples from older~     patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or~     without rituximab on clinical trial ECOG-E4494.~   "
203510|NCT00898144|"~     RATIONALE: Studying Pap smears in the laboratory from women with atypical glandular cells of~     unspecified significance may help doctors learn more about changes that may occur in DNA and~     identify biomarkers related to cancer.~      PURPOSE: This research study is looking at Pap smears from women enrolled on clinical trial~     GOG-171.~   "
203511|NCT00898131|"~     RATIONALE: Collecting and storing samples of tumor tissue from patients with breast cancer to~     study in the laboratory may help doctors learn more about cancer.~      PURPOSE: This phase I study is collecting tissue samples for future research from women~     undergoing surgery for breast cancer.~   "
203512|NCT00898118|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at blood samples in young patients with cytopenia~     after undergoing a donor stem cell transplant.~   "
203513|NCT00898092|"~     RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to~     study in the laboratory may help doctors learn more about changes that may occur in DNA and~     identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were~     collected from patients with acute myeloid leukemia.~   "
203514|NCT00898079|"~     This study is collecting and storing malignant, borderline malignant neoplasms, and related~     biological samples from young patients with cancer. Collecting and storing samples of tumor~     tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help~     the study of cancer in the future.~   "
203515|NCT00898066|"~     RATIONALE: Studying the chromosomes in samples of bone marrow and blood in the laboratory~     from patients with cancer or other blood diseases may help doctors learn more about the~     disease.~      PURPOSE: This laboratory study is analyzing chromosomes in patients with newly diagnosed~     multiple myeloma or other blood disease.~   "
203516|NCT00898053|"~     This laboratory study is looking at tumor samples from patients with Ewing sarcoma. Studying~     samples of tumor tissue from patients with cancer in the laboratory may help doctors learn~     more about changes that occur in DNA and identify biomarkers related to cancer~   "
203517|NCT00898040|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that may occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This laboratory study is looking at DNA samples from patients with multiple myeloma.~   "
203518|NCT00898027|"~     RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer~     receiving epidermal growth factor receptor inhibitors may help doctors understand the effect~     of epidermal growth factor receptor inhibitors on magnesium levels in the body.~      PURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor~     inhibitors on magnesium homeostasis in patients with cancer.~   "
203519|NCT00898014|"~     RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help~     doctors predict how patients will respond to treatment.~      PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting~     response in patients receiving first-line chemotherapy for stage IV breast cancer.~   "
203520|NCT00897988|"~     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This laboratory study is looking at the DNA in tumor tissue samples from patients~     with human papilloma virus-associated cancer of the oropharynx.~   "
203521|NCT00897975|"~     Red yeast rice may be useful to lower cholesterol, especially in a population of patients who~     cannot tolerate traditional therapy with statins.~      The addition of an over-the-counter phytosterol to red yeast rice may offer additional lipid~     lowering benefits when compared to red yeast rice alone.~      These supplements will be given to all participants. Up to one-half will enroll in a~     lifestyle intervention program called Change of Heart and will be compared to patients who do~     not participate in the program. The study will last one year.~   "
203522|NCT00897962|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at blood glycan biomarkers in women with stage IV~     breast cancer.~   "
203523|NCT00897949|"~     A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine~     attack and treatment of up to two headache recurrences compared to placebo.~      The long term extension study which pools patients from MK0462-022, -025, and -029 is~     described in NCT01286207.~   "
203524|NCT00897936|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how well patients respond to treatment.~      PURPOSE: This laboratory study is looking at tissue samples from patients with acute myeloid~     leukemia.~   "
203525|NCT00897923|"~     RATIONALE: Measuring the number of radiolabeled white blood cells in non-Hodgkin's lymphoma~     tumors may help doctors predict how well patients will respond to treatment, and may help the~     study of cancer in the future.~      PURPOSE: This study is measuring radiolabeled white blood cells in patients with~     non-Hodgkin's lymphoma.~   "
203526|NCT00897910|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about T cells and plan better treatment for multiple~     myeloma.~      PURPOSE: This research study is looking at T cells in blood and bone marrow samples from~     patients with multiple myeloma.~   "
203544|NCT00897663|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how patients will respond to treatment.~      PURPOSE: This laboratory study is looking at tissue samples from patients with glioblastoma~     multiforme to identify biomarkers that may improve the selection of patients for epidermal~     growth factor receptor inhibitor therapies.~   "
203545|NCT00897650|"~     RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with~     cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA)~     and may also identify protein expression patterns related to cancer. It may also help doctors~     predict how patients will respond to treatment.~      PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of~     predicting response to treatment in patients with lung cancer.~   "
203546|NCT00897637|"~     This laboratory study is using gene expression profiling to identify different categories of~     Wilms tumors. Studying the genes expressed in samples of tumor tissue from patients with~     cancer may help doctors identify biomarkers related to cancer.~   "
203527|NCT00897897|"~     This study is to confirm the safety and technical effectiveness of MRI guided High Intensity~     Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas.~     The importance of this therapy is that it offers a non-invasive, uterine sparing procedure~     for the treatment of uterine fibroids in pre- and peri- menopausal women.~      MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate~     fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the~     fibroid tissue. The goal of the study is to show treatment safety and technical~     effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion~     criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study~     patients.~      The goal of this study is to demonstrate that:~        1. The safety profile is acceptable (safety)~        2. Actual MR-HIFU ablated volumes (as measured with contrast enhanced MRI) match the~          intended volumes (technical effectiveness)~        3. When intended, volumes greater than 20% of the fibroid volume can be successfully~          ablated (technical effectiveness)~      The investigators' hypothesis is that greater than 70% of fibroids will have concordance~     between intended lesion volume and actual lesion volume while maintaining an acceptable~     safety profile.~   "
203528|NCT00897884|"~     The study will be testing metformin in patients with breast cancer who are about to undergo~     surgery. Patients will take metformin 3 times daily for about 2-3 weeks prior to their~     surgery date. It is hypothesized that metformin will reduce cell proliferation rates in~     tumour tissue.~   "
203529|NCT00897871|"~     RATIONALE: Studying samples of blood in the laboratory from young patients with cancer may~     help doctors learn how carboplatin, cyclophosphamide, and etoposide affect the body and how~     patients will respond to treatment.~      PURPOSE: This laboratory study is evaluating the side effects and how well anticancer drugs~     work in very young patients with cancer.~   "
203530|NCT00897858|"~     RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the~     laboratory may help doctors identify biomarkers related to cancer.~      PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis~     proteins in young patients with newly diagnosed central nervous system tumors.~   "
203531|NCT00897845|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at tumor samples from women who have undergone~     chemotherapy for breast cancer.~   "
203532|NCT00897832|"~     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This laboratory study is looking at biomarkers in predicting response to treatment~     in patients who have undergone surgery for pancreatic cancer.~   "
203533|NCT00897819|"~     RATIONALE: Studying samples of blood, urine, and tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients respond to~     treatment.~      PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with~     advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without~     bevacizumab on clinical trial E-3200.~   "
203534|NCT00897806|"~     RATIONALE: DNA analysis of tumor tissue from patients with cancer may help doctors predict~     how patients respond to treatment and plan the best treatment.~      PURPOSE: This laboratory study is identifying genetic markers that predict response to~     paclitaxel in patients with newly diagnosed stage III or stage IV ovarian epithelial cancer~     or primary peritoneal cancer.~   "
203535|NCT00897793|"~     RATIONALE: Measuring levels of transforming growth factor-beta (TGF-beta) in the blood of~     patients with epithelial cancers (head and neck, lung, breast, colorectal, and prostate) may~     help doctors predict how patients will respond to treatment with radiation therapy.~      PURPOSE: This research study is measuring levels of TGF-beta in patients with epithelial~     cancers who are undergoing radiation therapy.~   "
203536|NCT00897780|"~     The objective of the study is to examine the effect of combined treatments (biofeedback with~     virtual reality) for pediatric chronic headache.~   "
203537|NCT00897767|"~     RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer~     to study in the laboratory may help doctors learn more about diagnosing cancer and determine~     a patient's eligibility for a treatment clinical trial. It may also help the study of cancer~     in the future.~      PURPOSE: This laboratory study is collecting tissue samples from patients with leukemia or~     other blood disorders who are planning to enroll in an ECOG leukemia treatment clinical~     trial.~   "
203538|NCT00897754|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors understand how patients respond to treatment.~      PURPOSE: This laboratory study is looking at gene expression in patients with advanced or~     metastatic colorectal cancer receiving bevacizumab.~   "
203539|NCT00897741|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that may occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This laboratory study uses gene expression profiling to compare primary tumor cells~     with metastatic tumor cells in patients with metastatic pancreatic cancer.~   "
203540|NCT00897728|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is looking at tumor and blood samples from women with breast~     cancer.~   "
203541|NCT00897715|"~     There has been an exponential growth in the number of people with Chronic Kidney Disease~     (CKD) needing dialysis or transplantation, increasing from 209,000 in 1991 to 472,000 in~     2004. This is highly concerning due to both the human cost and the burden that it represents~     to the health care system. Recent comparison of the NHANES surveys showed that CKD prevalence~     increased from 10% in 1988-1994 to 13% in 1999-2004. Patients with CKD are more likely to die~     from premature cardiovascular death than to reach ESRD. In those that reach ESRD,~     cardiovascular disease (CVD) accounts for over half of the deaths in dialysis. The prevalence~     of CKD for the VA population is 20%, and 31.6% for diabetics, higher than in the general~     population. These observations emphasize the need of risk stratification, early detection,~     and prevention efforts with respect to CKD progression and the CVD burden that afflicts CKD~     through targeted interventions in high-risk groups (personalized medicine).~      CKD is multifactorial, however familial aggregation of end-stage renal disease (ESRD) and CKD~     have been reported for all types of nephropathy underscoring kidney disease genetic~     susceptibility . Genetic predisposition to ESRD is stronger in African Africans. African~     Americans with a first-degree relative with ESRD have a 9-fold increase risk of ESRD vs. a~     3-5 fold increase in whites.~      Studies consistently show that CKD is an inflammatory process and that biomarkers of~     inflammation increase since early stages of CKD. CVD is also an inflammatory process, and~     genes that affect inflammation are associated with higher risk of CVD. Since inflammation is~     a common denominator of both disease processes (CKD and CVD), it is likely that genes that~     govern inflammation may be involved in both, the predisposition to CKD and the burden of CVD~     attributable to CKD. Additionally if inflammation plays a central role in the burden of CVD~     in CKD than drugs that modulate inflammation should impact both: CKD progression and~     non-traditional CV risk factors and CVD.~      The overall goal of this proposal is to study genetic predisposition to CKD, and CVD risk in~     CKD through inflammatory pathways, and the effect that a potent anti-inflammatory~     intervention like interleukin 1 receptor antagonist (IL-1ra), will have in inflame patients~     with CKD stages 3&4. Specific Aims: 1) To determine if specific polymorphism/haplotypes,~     genotype combinations and gene-environmental interactions that can affect inflammation,~     available from the Third National Health and Nutrition Examination Survey (DNA data set),~     specifically in the CRP,IL-1, IL-10 and TNF- genes, are associated with CKD. 2) To determine~     if the specific polymorphisms and haplotypes studied in Aim 1 are associated with faster CKD~     progression and CV outcomes in a longitudinal cohort from the African American Study of~     Kidney Disease. 3)To determine if a targeted anti-inflammatory intervention, an IL-1 receptor~     antagonist, will modulate systemic inflammation, endothelial function, oxidative stress and~     urinary cytokines, the proposed surrogate markers of CVD and CKD progression in inflame~     patients with CKD stages 3&4.~   "
203542|NCT00897702|"~     The purpose of this study is to learn why certain drugs stop working in patients.In lab~     studies, tumors become resistant in several ways. Specific molecules seem to change and this~     may be why therapy stops working. However, we do not know if the same molecules change in~     patients. This study is being done to see if they do change. If we learn more about how~     patients become resistant, we may be able to offer better treatment in the future.~   "
205269|NCT00874744|"~     The purpose of this study is to compare a single intravitreal injection of 4.0 mg of~     triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular~     edema.~   "
203548|NCT00897611|"~     RATIONALE: Studying levels of tumor DNA in the samples of blood from patients with cancer may~     help doctors find out whether the cancer has grown and how much.~      PURPOSE: This laboratory study is comparing levels of tumor DNA with MRI and CT scan findings~     to measure cancer growth in patients with grade III or grade IV malignant glioma.~   "
203549|NCT00897559|"~     RATIONALE: Studying the genes expressed in samples of bone marrow from patients with cancer~     may help doctors identify biomarkers related to cancer.~      PURPOSE: This research study is looking at bone marrow samples from patients with acute~     leukemia.~   "
203550|NCT00897546|"~     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the~     laboratory may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer, and may help doctors learn how well patients will respond to~     treatment.~      PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon~     therapy in patients with melanoma.~   "
203551|NCT00897533|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients respond to treatment with erlotinib.~      PURPOSE: This laboratory study is developing a model to predict progression-free survival~     after erlotinib in patients with non-small cell lung cancer.~   "
203552|NCT00897520|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors identify biomarkers related to cancer and predict how patients will respond to~     treatment.~      PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma~     receiving high-dose interferon therapy.~   "
203553|NCT00897507|"~     RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will~     respond to treatment~      PURPOSE: This laboratory study is looking at DNA in tumor tissue samples from young patients~     with acute lymphoblastic leukemia.~   "
203554|NCT00897494|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that may occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This laboratory study is examining blood samples from patients with cancer to~     identify biomarkers that may help in the early detection of pancreatic cancer.~   "
203555|NCT00897481|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help the study of cancer in the future.~      PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma~     who have undergone sentinel lymph node biopsy.~   "
203556|NCT00897468|"~     RATIONALE: Changing the genes in laboratory mice to create a living model of human breast~     cancer may help doctors learn more about breast cancer.~      PURPOSE: This research study is developing mouse models of breast cancer using tissue samples~     that were previously collected from women with breast cancer.~   "
203557|NCT00897455|"~     RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation~     carriers may help doctors learn more about cancer and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2~     mutation carriers.~   "
203558|NCT00897442|"~     This laboratory study is collecting tumor tissue and blood samples from patients with~     gynecologic tumors. Collecting and storing samples of tumor tissue and blood from patients~     with cancer to study in the laboratory may help in the study of cancer.~   "
203559|NCT00897429|"~     This research trial studies tissue samples from patients with stage II colon cancer treated~     on Cancer and Leukemia Group B (CALGB)-9581 or CALGB-90903. Studying samples of tissue from~     patients with cancer in the laboratory may help doctors learn more about changes that occur~     in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help~     doctors understand how patients respond to treatment.~   "
203560|NCT00897416|"~     RATIONALE: Collecting and storing samples of blood and studying them in the laboratory may~     help doctors learn more about changes that may occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This laboratory study is examining biomarkers in women with a high risk or average~     risk of breast cancer.~   "
203561|NCT00897403|"~     RATIONALE: Collecting and storing samples of blood and tissue from patients undergoing~     colonoscopy to study in the laboratory may help doctors learn more about colon cancer and~     identify biomarkers related to colon cancer in the future.~      PURPOSE: This laboratory study is collecting blood and tissue samples for future colon cancer~     biomarker studies in patients undergoing colonoscopy.~   "
203562|NCT00897390|"~     To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage)~     immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet~     and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed~     state.~   "
203563|NCT00897377|"~     Although the prognosis of patients with low-grade glioma (LGG) is generally good, recurrence~     seems unavoidable in some patients because of the infiltrative growth of the tumors. How to~     treat LGGs is still under controversy. The role of radiation therapy and chemotherapy in the~     treatment of LGG need to be further investigated. The purpose of this study is the following:~        1. to investigate the role of early radiation therapy in MRI-determined total resected~          LGGs;~        2. to compare the efficacy of early radiation therapy and that of initial chemotherapy in~          the LGGs without total resection.~   "
203564|NCT00897364|"~     RATIONALE: Studying samples of tissue from smokers and non-smokers in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This phase II study is looking at biomarkers in the nose, throat, and lung tissue of~     smokers and non-smokers.~   "
203565|NCT00897351|"~     RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with~     cancer may help doctors learn more about changes that occur in DNA and identify biomarkers~     related to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at tissue and blood samples from patients with~     recurrent prostate cancer who received lapatinib on clinical trial ECOG-E5803.~   "
203747|NCT00894868|"~     This study will assess the effect of vildagliptin on left ventricular function in patients~     with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and~     overall safety and tolerability will also be assessed.~   "
203566|NCT00897338|"~     RATIONALE: Studying samples of blood and pleural or peritoneal fluid from patients with~     metastatic breast cancer in the laboratory may help doctors identify biomarkers related to~     breast cancer and learn more about how breast cancer begins and spreads in the body.~      PURPOSE: This research study is looking at a new way of identifying circulating breast cancer~     cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.~   "
203567|NCT00897325|"~     This research study is collecting and storing samples of bone marrow and blood from patients~     with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma. Collecting and~     storing samples of bone marrow and blood from patients with cancer to study in the laboratory~     may help doctors learn more about cancer and help predict the recurrence of cancer.~   "
203568|NCT00897312|"~     RATIONALE: Studying samples of blood from patients with cancer, hepatitis C, or Crohn disease~     in the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer and other diseases.~      PURPOSE: This laboratory study is looking at the effect of biological therapy on biomarkers~     in patients with untreated hepatitis C, metastatic melanoma, or Crohn disease.~   "
203569|NCT00897299|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict whether cancer will come back after treatment.~      PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women~     with breast cancer treated with chemotherapy.~   "
203570|NCT00897286|"~     This laboratory study is looking at stored tumor samples in young patients with brain tumors.~     Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to cancer.~   "
203571|NCT00897273|"~     RATIONALE: Gathering information about human papillomavirus infection of the mouth in young~     men may help doctors learn more about risk factors for oropharyngeal cancer.~      PURPOSE: This research study is assessing human papillomavirus infection of the mouth in~     young men and risk factors for oropharyngeal cancer.~   "
203572|NCT00897260|"~     To determine the time to and rate of hematologic engraftment following unrelated umbilical~     cord blood transplantation in adults with one or two cord blood units using total body~     irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as~     graft-versus-host disease prophylaxis.~   "
203573|NCT00897247|"~     RATIONALE: Studying samples of body fluid and blood from patients who have been exposed to~     asbestos or vermiculite in the laboratory may help doctors learn more about changes that may~     occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking for biomarkers to detect mesothelioma early in~     patients exposed to asbestos or vermiculite.~   "
203574|NCT00897234|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at blood samples from patients with non-small cell~     lung cancer and from healthy volunteers.~   "
203575|NCT00897221|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     deferiprone in subjects with Friedreich's ataxia (FRDA).~      The secondary objective is to evaluate the long-term efficacy of deferiprone for the~     treatment of FRDA.~      The tertiary objectives are to evaluate the effect of deferiprone on:~        1. cardiac function,~        2. quality of life, and~        3. functional status.~   "
203576|NCT00897208|"~     RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients~     with cancer and from patients at risk of developing cancer may help doctors identify and~     learn more about biomarkers related to cancer. It may also help doctors learn more about~     breast cancer and identify patients at risk of developing breast cancer.~      PURPOSE: This laboratory study is looking at biomarkers in nipple fluid, urine, and blood~     samples from women with newly diagnosed ductal carcinoma in situ or stage I or stage II~     breast cancer and in women at risk of developing breast cancer.~   "
203577|NCT00897182|"~     RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with~     cancer may help doctors learn more about changes that occur in DNA and identify genes related~     to cancer. It may also help doctors diagnose cancer and predict how patients will respond to~     treatment.~      PURPOSE: This research study is identifying cancer-related genes in blood and/or bone marrow~     samples from patients with acute myeloid leukemia.~   "
203578|NCT00897169|"~     This trial is conducted in Europe and Japan. The aim of this clinical trial is to investigate~     the possible difference in the development of type 2 diabetes in a Japanese and a Caucasian~     population. Healthy subjects, subjects with impaired glucose tolerance, as well as subjects~     with type 2 diabetes will be included in the trial. The development of type 2 diabetes across~     the cohort will be investigated with regard to insulin sensitivity and B-cell capacity.~   "
203579|NCT00897143|"~     RATIONALE: Studying samples of pleural fluid in the laboratory from patients with lung cancer~     may help doctors identify early lung cancer cells. It may also help the study of lung cancer~     in the future.~      PURPOSE: This laboratory study is looking at malignant pleural effusion samples from patients~     with primary lung cancer to see if early lung cancer cells can be identified.~   "
203580|NCT00897130|"~     Azacitidine will be given at a dose of 75 mg/sqm (s.c) daily for 5 consecutive days every 28~     days (every month) for a total of 8 courses to low risk MDSs according to IPSS scoring~     system. In fact, several studies produced high rates of trilineage responses, reduces the~     risk of progression to acute myeloid leukemia (AML) in high-risk MDS and improves the quality~     of life (QoL). The use of 5-Aza in the earlier phases of MDS could reduce the proliferative~     advantage of MDS clone and favour the regrowth of normal hematopoiesis.~   "
203581|NCT00897117|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that may occur in RNA and identify biomarkers related~     to cancer.~      PURPOSE: This research study is collecting and analyzing lung tissue samples from patients~     undergoing surgery for non-small cell lung cancer.~   "
203582|NCT00897104|"~     A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for~     the acute treatment of a migraine attack.~   "
203773|NCT00894530|"~     The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic~     solution, 1% versus placebo over a four-week treatment period.~   "
203583|NCT00897091|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This laboratory study is looking at biomarkers in predicting outcome in~     postmenopausal women with hormone receptor-positive, node-positive breast cancer treated with~     tamoxifen with or without cyclophosphamide, doxorubicin, and fluorouracil.~   "
203584|NCT00897078|"~     RATIONALE: Gathering information about metabolic syndrome from young patients who have~     survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease.~      PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have~     survived acute lymphoblastic leukemia and in healthy sibling volunteers.~   "
203585|NCT00897065|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how well patients respond to treatment.~      PURPOSE: This laboratory study is looking at biomarkers that may predict response to~     tamoxifen and letrozole in postmenopausal women with primary breast cancer treated on~     clinical trial CAN-NCIC-MA17.~   "
203586|NCT00897052|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict survival of patients with head and neck cancer.~      PURPOSE: This laboratory study is assessing gene expression profiles in predicting survival~     of patients with head and neck cancer.~   "
203587|NCT00897039|"~     RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory~     may help doctors predict how well patients will respond to treatment with certain~     chemotherapy drugs and plan the best treatment.~      PURPOSE: This laboratory study is looking at tumor tissue samples to predict response to~     chemotherapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal~     cancer.~   "
203588|NCT00897026|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors plan the best treatment.~      PURPOSE: This research study is looking at tissue samples from women who underwent~     chemotherapy for lymph node-positive stage II or stage IIIA breast cancer.~   "
203589|NCT00896987|"~     The purpose of this study is to compare the effect of anti-epileptic drugs' (AEDs) long-term~     treatment on cognitive function. This study is an open-label, randomized, multicenter~     comparative trial of lamotrigine versus carbamazepine. The planned enrollment is 100~     patients.~   "
203590|NCT00896974|"~     This research study is looking at 9cUAB30 in healthy participants. Studying samples of blood~     and urine from healthy participants may help doctors learn more about how 9cUAB30 is used by~     the body.~   "
203591|NCT00896961|"~     This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft~     tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells~     may help in planning cancer treatment~   "
203592|NCT00896948|"~     RATIONALE: Studying proteins in head and neck cancer cells in the laboratory may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at proteins in head and neck cancer cells.~   "
203593|NCT00896935|"~     RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to~     test in the laboratory may help the study of cancer in the future.~      PURPOSE: This research study is collecting and storing tumor, tissue, and blood samples from~     patients with pancreatic cancer.~   "
203594|NCT00896922|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how patients respond to treatment.~      PURPOSE: This laboratory study is examining biological markers in patients with follicular~     lymphoma treated on clinical trial SWOG-8809, SWOG-9800, or SWOG-9911.~   "
203595|NCT00896909|"~     RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the~     laboratory may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients~     with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial~     ECOG-2598.~   "
203596|NCT00896896|"~     RATIONALE: Studying samples of blood in the laboratory may help doctors predict which~     patients will develop hypersensitivity to cetuximab.~      PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with~     head and neck cancer or advanced colorectal cancer previously treated with cetuximab.~   "
203597|NCT00896883|"~     The purpose of this study is to determine the functional performance of the Middle Turbinate~     Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in~     which the Principal Investigator determines clinical relevance.~   "
203598|NCT00896857|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is evaluating cells collected through ductal lavage in women~     undergoing surgery for ductal carcinoma in situ or other breast cancer.~   "
203599|NCT00896844|"~     This is a randomized, controlled trial on the effect of emotional disclosure of traumatic~     life events on physical health. The hypothesis is that expression of emotions could possibly~     improve physical health.~   "
203600|NCT00896831|"~     The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the~     management of hepatic encephalopathy.~   "
203601|NCT00896818|"~     RATIONALE: Studying samples of blood, urine, and tumor tissue in the laboratory from patients~     with cancer and their female relatives and friends may help doctors learn more about changes~     that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This research study is looking at genes and other risk factors for second primary~     breast cancer in women with breast cancer and in their female family members and friends.~   "
203774|NCT00894517|"~     This is a 24 week study evaluating the effects of botulinum toxin Type A on semen quality in~     patients with signs and symptoms of Benign Prostatic Hyperplasia (BPH).~   "
203602|NCT00896792|"~     RATIONALE: Gathering information about patients with terminal metastatic cancer may help~     doctors learn more about the effectiveness of a nurse practitioner hospice program. It is not~     yet known whether a nurse practitioner program helps increase patients' length of stay in~     hospice.~      PURPOSE: This randomized research study is evaluating a nurse practitioner hospice program~     for patients with terminal metastatic cancer and their families or caregivers.~   "
203603|NCT00896779|"~     Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase~     III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in~     improved visual function in such patients.Since ranibizumab has been shown to be the most~     effective therapy for exudative macular degeneration we propose to treat all patients in this~     study with monthly ranibizumab intravitreal injections.~      Patients will be assigned to one of two groups by the flip of a coin. Group #1 for heads~     and Group #2 for tails.~      Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then~     as needed therapy.~      Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as~     needed therapy.~   "
203604|NCT00896766|"~     RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer~     to study in the laboratory may help doctors learn more about changes that may occur in DNA~     and identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at lymphoblasts in young patients with high-risk~     acute lymphoblastic leukemia.~   "
203605|NCT00896753|"~     RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may~     help doctors identify biomarkers related to cancer.~      PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue~     and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or~     peritoneum.~   "
203606|NCT00896740|"~     RATIONALE: Studying samples of bone marrow from patients with Fanconi anemia and from healthy~     participants in the laboratory may help doctors learn more about changes that occur in DNA~     and identify biomarkers related to Fanconi anemia.~      PURPOSE: This laboratory study is evaluating gene function in bone marrow cells from patients~     with Fanconi anemia and from healthy participants.~   "
203607|NCT00896727|"~     RATIONALE: Studying the proteins expressed in tumor tissue samples in the laboratory from~     patients with cancer may help doctors learn more about biomarkers related to cancer. It may~     also help doctors predict how patients respond to treatment.~      PURPOSE: This laboratory study is looking at protein expression in predicting response to~     treatment using tumor tissue samples from women with stage I, stage II, or stage IIIA breast~     cancer treated on clinical trial SWOG-9313.~   "
203608|NCT00896714|"~     The main objective of the study is to analyze the influence of several environmental (i.e.,~     timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle)~     on anesthetic drug requirements (hypnotic and opiate).~   "
203609|NCT00896701|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors predict response in patients previously treated with~     interleukin-2.~      PURPOSE: This laboratory study is looking at the relationship between natural killer cells'~     ability to kill leukemia cells and the outcome of patients with acute myeloid leukemia~     previously treated with interleukin-2.~   "
203610|NCT00896688|"~     The diagnostic cervical branch block for neck pain due to cervical facet joint pain has been~     traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been~     well established. However, recently some studies have shown that the diagnostic cervical and~     lumbar medial branch block can be done under ultrasound guidance.~   "
203611|NCT00896675|"~     RATIONALE: Studying samples of blood in the laboratory may help doctors learn more about~     cancer. It may also help doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is looking at proteins in blood samples to predict treatment~     benefit in patients with recurrent and/or metastatic squamous cell head and neck cancer.~   "
203612|NCT00896662|"~     RATIONALE: Studying the dendritic cells in samples of blood from patients with cancer~     receiving aflibercept may help doctors learn about the effect of aflibercept on dendritic~     cells.~      PURPOSE: This laboratory study is evaluating dendritic cells in patients with advanced solid~     tumors or non-Hodgkin lymphoma receiving aflibercept on clinical trial VGFT-ST-0202.~   "
203613|NCT00896649|"~     RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment~     for breast cancer. It is not yet known whether positron emission mammography is more~     effective than standard mammography in finding breast tumors.~      PURPOSE: This phase III trial is studying positron emission mammography to see how well it~     works compared with standard mammography in women undergoing screening mammogram at Boston~     Medical Center.~   "
203614|NCT00896636|"~     RATIONALE: Studying samples of blood and breast tissue from healthy women in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to breast cancer risk.~      PURPOSE: This research study is looking at breast tissue in women not previously diagnosed~     with breast cancer who are undergoing fine-needle aspiration.~   "
203615|NCT00896623|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict a patient's response to treatment.~      PURPOSE: This laboratory study is looking at DNA in tissue samples from women with breast~     cancer to see if it can predict treatment outcome.~   "
203629|NCT00896428|"~     Severe asthma is a difficult to treat disease, characterized by bronchial remodelling, which~     is an abnormal repair process that contributes to the development of poorly reversible airway~     narrowing. Such remodelling is now considered as one of the main prognostic factors.~     Gallopamil-sensitive calcium influx plays a key role in this remodelling process in vitro.~     The objective of this study is to compare the effects of gallopamil versus placebo on the~     bronchial smooth muscle remodelling in severe asthmatic patients.~   "
203649|NCT00896168|"~     The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate~     (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune~     disease that causes pain, swelling, stiffness and loss of function in joints) in participants~     with moderate disease versus participants with severe disease and to compare the efficacy and~     safety of the MTX subgroups.~   "
203616|NCT00896610|"~     Background:~        -  Diabetes is a disease defined by abnormally high blood sugar (glucose) levels. Glucose~          is an essential source of energy for the body s cells, but insulin is required to move~          the glucose into the cells. Insulin is a hormone produced by the pancreas that allows~          glucose to enter cells.~        -  In diabetes, the body is unable to supply enough insulin to meet its demands. The~          problem may be a low supply of insulin or a high demand for insulin. Someone who has~          been diagnosed with diabetes has lost much of their insulin-producing capacity. Clinical~          studies have shown that good control of blood sugar is essential to prevent diabetes~          complications like damage to the eyes, kidneys, nerves, and blood vessels.~      Objectives:~        -  To establish a relationship with several individuals with diabetes caused by the immune~          system attacking the body s insulin-producing cells in order to:~        -  Explore why the immune system attacks insulin-producing cells.~        -  Understand why some individuals develop diabetes-related complications and others do~          not.~        -  Develop therapies to improve how patients can control their blood sugar levels.~        -  Continue to follow subjects who have completed or are considering other NIH~          diabetes-related studies.~        -  To develop improved tests for determining an individual s risk for developing diabetes~          and/or to accurately diagnose the exact type of diabetes.~      Eligibility:~        -  Individuals who have been diagnosed with or are at risk for developing diabetes.~      Design:~        -  Standard physical examination and clinical tests to determine if the patient has~          diabetes or to confirm a particular type of diabetes:~        -  None of the treatment in this study is experimental.~        -  Patients will receive a separate consent form for any special tests needed to learn more~          about their particular type of diabetes.~        -  Patients may be asked to provide additional urine and blood samples for use in~          laboratory research about diabetes.~        -  Researchers may offer medical treatment advice for diabetes, or explain how to improve~          patients diabetes management skills.~   "
203617|NCT00896597|"~     This is an open, randomized study in patients with different severity stages of hepatic~     cirrhosis, in which rater pairs will be used for the assessment of the intra- and inter-rater~     reproducibility of NRL972 pharmacokinetics and CTP sum score. Rating will be performed by 32~     to 40 pairs of raters. The raters will perform the required assessments in the capacity of~     sub-investigators of the phase I (co-ordinating) unit.~      Up to 240 patients with clinically established hepatic cirrhosis without confounding~     end-stage co-morbidity (stable disease) will be studied. Within 30 days of confirmation of~     eligibility, Visit 1 will take place to determine the investigational parameters (NRL972~     pharmacokinetics, clinical laboratory tests, and determination of CTP sum score). At~     approximate intervals of one week, Visits 2, 3 and 4 will occur, and the investigational~     parameters will again be assessed.~   "
203618|NCT00896584|"~     Some patients with chronic obstructive pulmonary disease (COPD) need supplementary oxygen~     during air travel. Guidelines issued by The British Thoracic Society (BTS) for pre-flight~     evaluation do not discriminate sufficiently between those who need supplementary oxygen~     during flight, and those who can do without. Previous studies have indicated that decreasing~     hemoglobin oxygen saturation during exercise may predict in-flight hypoxemia. The objective~     of the present study is to examine if adding exercise oxygen desaturation to the BTS~     algorithm will better predict requirements for in-flight supplementary oxygen.~   "
203619|NCT00896571|"~     The aim of the present study is to investigate the effects of the transdermal patch on the~     endometrium in healthy women who require contraception.~   "
203620|NCT00896558|"~     This study will be the first repeat dose administration of GSK1322322 to investigate safety,~     tolerability, and pharmacokinetics in healthy subjects as well as elderly volunteer subjects.~     The study will also include a P450 probe drug (midazolam) to evaluate the effect of~     GSK1322322 to inhibit or induce CYP3A4 substrates.~   "
203621|NCT00896545|"~     You are invited to participate in a research study to understand more about childhood obesity~     and how to prevent it. We hope to learn how families influence each others eating habits.~   "
203622|NCT00896532|"~     The primary objective was to determine the effect of treatment with romosozumab versus~     placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the~     lumbar spine in postmenopausal women with low bone density.~   "
203623|NCT00896519|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Colony-stimulating factors, such as GM-CSF, may cause the body to make~     more blood cells and help it recover from the side effects of rituximab and combination~     chemotherapy.~      PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab and~     combination chemotherapy works in treating patients with previously untreated advanced~     follicular non-Hodgkin lymphoma.~   "
203624|NCT00896493|"~     Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given~     that the median age at diagnosis is 55-60 years and frequently present compromised skin in~     these patients, which increases the risk of infection. Therefore, we propose a clinical study~     with allogeneic HSCT using a unique non-myeloablative preparative regimen, TLI/ATG, to treat~     advanced MF/SS.~   "
203625|NCT00896480|"~     The clinical objective of this clinical trial is to examine the clinical activity in terms of~     tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A~     when given to patients with unresectable and progressive metastatic cutaneous melanoma. The~     safety of the treatment will also be assessed just as its immunogenicity in terms of the~     humoral and cellular immune response induced by the GSK2132231A immunotherapeutic.~     Translational research objectives are to assess the effects of the study treatment in terms~     of various biological variables.~   "
203626|NCT00896467|"~     RATIONALE: Gathering information from patients who received treatment for metastatic cancer~     while participating in a phase II or phase III randomized clinical trial and from patients~     receiving standard treatment off-trial may help doctors learn more about the psychological~     and emotional results of being in a clinical trial.~      PURPOSE: This clinical trial is comparing the psychological and emotional impact of~     participating in a randomized clinical trial with the impact of standard treatment in~     patients with metastatic cancer.~   "
203627|NCT00896454|"~     The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia~     of Malignancy in patients with elevated serum calcium who do not respond to recent treatment~     with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9~     millimoles /L) by day 10.~   "
203628|NCT00896441|"~     The purpose of this study is to help us understand how depression changes brain activity and~     how this relates to mood, anxiety, and cognitive functions like memory. We also hope to~     develop a brain imaging test that will predict either before or within two weeks of starting~     a medicine whether the treatment will work.~   "
206371|NCT00860119|"~     This study tests the assumption that the bioavailability of alprazolam from a new sublingual~     formulation is the same as that from a standard orally administered tablet.~   "
203630|NCT00896415|"~     Maintaining strong muscles is important for the independence and quality of life in our older~     population. Strong muscles provide mobility and reduce the chance of falls that lead to~     injury. Many researchers are carrying out studies to examine different types of exercise and~     drug treatments to prevent loss of muscle strength in older people. Often, these research~     studies use x-ray computed tomography (CT) scans to measure the size and the amount of fat in~     different muscles. These factors are known to reflect muscle health. Large studies can~     involve many research subjects recruited at many different clinics with different CT~     scanners. To ensure that these studies provide reliable results, the investigators must have~     procedures to make sure that different CT scanners measure the same results for the same~     amount of fat or muscle. The goal of our study is to develop these procedures. In this~     project, the investigators will study women because they have the highest risk of bone~     fractures resulting from falls. Thus, the subjects are being asked to volunteer for a study~     where the subjects will be scanned on different scanners.~   "
203631|NCT00896402|"~     Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the~     management of postoperative pain after total knee arthroplasty. Although the risk of full~     blown infection with CFNB has been poorly defined, the rate of catheter colonization after~     antisepsis with povidone-iodine has been demonstrated to be high (Cuivillion et al. showed~     the rate of colonization to be 57% after 48 hours). Recently, several anecdotal case reports~     have demonstrated severe infectious complications including psoas abscess and necrotizing~     fasciitis associated with continuous nerve block techniques. As the use of CFNB techniques~     increase in popularity, infectious complications will undoubtedly become more common.~      The American Society of Regional Anesthesia and Pain Medicine recommends the routine use of~     antiseptic solutions with an alcohol base for skin disinfection before peripheral regional~     techniques due to their penetration of the stratum corneum and their rapid and prolonged~     effect. Chlorhexidine(chloraprep) has been proven to be better than povidone iodine solution~     for skin preparation before epidural catheter and intravascular device insertion (Kinirons et~     al., Ostrander et al., Mimoz et al.,). The goal of this prospective trial therefore is to~     determine if an alcoholic solution of 0.5% chlorhexidine is more effective than an aqueous~     solution of 10% povidone-iodine in reducing catheter colonization and reducing skin flora~     associated with short term ( 48 hours) postoperative continuous femoral nerve catheter~     placement. The investigators will also compare the ability of chloraprep and betadine~     disinfection at the time of catheter placement to prevent bacterial contamination of the~     continuous femoral catheter.~   "
203632|NCT00896389|"~     The investigators of this study propose to examine the relationships between STK39 (Serine~     Threonine Kinase 39) genotypes and responses to salt loading and to thiazide diuretics,~     hydrochlorothiazide. The investigators hypothesize that STK39 genotypes will be associated~     with the outcome of both interventions and can contribute to personalized care for~     hypertension.~   "
203633|NCT00896376|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women~     with metastatic breast cancer.~   "
203634|NCT00896363|"~     The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The~     safety and how well the body can handle the drug will also be investigated. The study will be~     conducted in Russia in hospitalised patients with severe depression. GSK163090 will be~     compared with placebo, which looks like the study drug but does not contain any active~     substance. Subjects will be given either the study drug or the matching placebo.~   "
203635|NCT00896350|"~     RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in~     tumor cells and may help in planning cancer treatment.~      PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding~     hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV~     head and neck cancer.~   "
203636|NCT00896337|"~     The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary~     stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.~   "
203637|NCT00896324|"~     RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think,~     learn, and remember. Gathering information about a woman's genes, brain function, and~     personal history may help doctors learn more about the disease and plan the best treatment.~      PURPOSE:~        1. To determine changes in brain function that occur following breast cancer chemotherapy.~        2. To gain further understanding of the individual differences in brain function changes~          and recovery based on demographic, medical and treatment variables.~   "
203638|NCT00896311|"~     Breech presentations (where a baby presents with feet or bottom down) have an increased risk~     of perinatal and neonatal complications, and are usually delivered by cesarean section. As an~     alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the~     baby so that it is head down: this manoeuvre is called an external cephalic version (ECV).~      Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success~     rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested~     as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in~     women who have not previously been pregnant (nulliparous women) than in women who have been~     pregnant more than once (multiparous women), and so we have planned two trials.~      This study is designed to answer the following questions for nulliparous women:~      Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates?~     Will an increase in ECV success result in a decreased cesarean section rate?~   "
203639|NCT00896298|"~     Lipodystrophies represent a therapeutic challenge with regards to insulin resistance,~     hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue~     loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects~     with lipodystrophy.~   "
203640|NCT00896285|"~     Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid~     with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming~     back again, patients are given a medicine (talc) into the chest drain to seal up the space~     around the lung. This procedure is known as pleurodesis. This sometimes causes pain and~     discomfort, and the investigators do not know the best way of preventing this.~      The investigators hope to find the best way to prevent pain during pleurodesis.~   "
203641|NCT00896272|"~     This study aims to understand the impact of living with Klinefelter syndrome (KS) and the~     factors that contribute to adaptation in adolescents and adults. Individuals with KS may have~     variable symptoms, including hypogonadism, gynecomastia, learning disabilities, and delay and~     underdevelopment of secondary sexual characteristics. Perhaps the most challenging symptom of~     KS is infertility, which seems to be a universal symptom. It is not fully understood how~     males with KS conceptualize their condition, cope with their diagnosis, and adapt to living~     with this condition. In this study, Lazarus and Folkman s Transactional Model of Stress and~     Coping provides a framework for examining coping and adaptation in males with KS. A~     cross-sectional research design using a quantitative survey will be utilized to examine the~     relationships among appraisals (illness perceptions and perceived stigma), time elapsed since~     learning of diagnosis, coping, and adaptation. Adolescents and adults with KS will be~     recruited from national KS support networks via website postings, email listservs, and~     printed newsletter postings. Adolescents will also be recruited from a private practice.~     Participants will have the option to complete an online or paper version of the survey. The~     main outcome variable is adaptation to living with a KS diagnosis....~   "
203642|NCT00896259|"~     A group of orthopedic physiotherapists have developed a late phase program to educate and~     instruct total hip replacement patients in progressive exercises appropriate for their level~     of recovery. The components of this program include an educational presentation, individual~     assessment and exercise prescription. The investigators' intent is to pilot the program using~     a sample of patients. The objective of this pilot project:~      To examine the effects of the late phase education session and home-based exercise program in~     restoring hip muscle strength, gait and function~   "
203643|NCT00896246|"~     This was a phase 1, open-label, randomized study, designed to assess the impact of Moviprep®~     or Klean-Prep® on gastrointestinal transit. It was performed in two parallel groups with Part~     A in two groups of four subjects preceding Part B, which was performed in two groups of 12~     subjects. Subjects attended a pre-study medical within 28 days of dosing and a post-study~     medical 5-10 days after the final dose. Within both Part A and Part B, subjects were required~     to attend the clinical unit for 2 study periods. Part A consisted of a baseline period to~     determine individual reference times for gastrointestinal transit. Part B was the test period~     in which gastrointestinal transit following the administration of the test preparations was~     assessed.~   "
203644|NCT00896233|"~     This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both~     healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the~     groundwork for the validation of MRE as an alternative to liver biopsy.~   "
203645|NCT00896220|"~     Advances in critical care medicine have dramatically improved the survival of critically ill~     patients requiring prolonged mechanical ventilation. However, there are no systematic~     follow-up, rehabilitation, or psychoeducational interventions for these vulnerable patients~     or their family caregivers who contribute to survivor recovery and rehabilitation. Major~     barriers to developing these programs for survivors of prolonged mechanical ventilation and~     their caregivers include the following:~        1. There is inadequate information about the determinants of long-term functional outcomes~          for a diverse group of survivors of prolonged mechanical ventilation.~        2. There is inadequate information about the needs of survivors of prolonged mechanical~          ventilation and their family caregivers across the trajectory of illness (i.e., from the~          ICU to the community).~        3. There is a poor understanding of the development of ICU-acquired muscle injury.~      Towards RECOVER is the very first study to identify survivors of prolonged mechanical~     ventilation who are at-risk for poor functional outcomes, to identify elements of the~     care-giving situation that put caregivers at risk for poor quality of life and mental health,~     to catalogue the rehabilitative needs of patients and family caregivers across the illness~     trajectory, and to evaluate the mechanism of critical illness associated muscle injury.~      The RECOVER Program consists of Four Phases:~        -  Phase I: Towards RECOVER~        -  Phase II: RECOVER development and pilot testing~        -  Phase III: RECOVER randomized controlled trial~        -  Phase IV: Long-term implementation of RECOVER~   "
203646|NCT00896207|"~     This randomized early phase I trial is studying different formulations of SR13668 in healthy~     volunteers. Giving SR13668 may help doctors learn more about how SR13668 is used by the body.~     It is not yet known which formulation of SR13668 is most effectively used by the body.~   "
203647|NCT00896194|"~     This randomized clinical trial of weight loss treatment will examine if adding personalized,~     one-on-one treatment session to standard behavioral group treatment will result in greater~     weight loss, less weight regain after weight loss, and better adherence to the treatment~     protocol.~      Everyone who enrolls in the study will receive information on healthy eating, how to increase~     their physical activity and develop healthy exercise habits and ways to change their eating~     so that they will lose weight. This information will be provided at evening group sessions.~     There will be a total of 20 group meetings over an 18-month period that will be held:~        -  every week during the first month of the study,~        -  every other week for the second month~        -  once a month for months 3-12~        -  every 6 weeks for months 13-18~      Participants in the self-efficacy group will also be asked to participate in one-on-one~     lifestyle counseling sessions with a study interventionist throughout the study.~      Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the~     phone, and have blood tests done every six months (at the beginning of the study, at 6, 12,~     and 18 months) a total of 4 times for the study.~   "
203648|NCT00896181|"~     This phase II trial is studying whether giving a combination of docetaxel, cisplatin, and~     fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy~     works in treating patients with advanced nasopharyngeal cancer. Drugs used in chemotherapy,~     such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a~     high dose of radiation directly to the tumor may kill more tumor cells and cause less damage~     to normal tissue. Giving combination chemotherapy together with radiation therapy may kill~     more tumor cells.~   "
203662|NCT00895973|"~     The investigators hypothesize that the rate of perineal lacerations in nulliparous women will~     be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery~     versus conventional delivery in obstetrical stirrups.~   "
203650|NCT00896155|"~     Two hundred and sixty patients with breast cancer will be accrued into the study. After~     inclusion in the study, all the patients will be randomized into two arms. Arm 1 will receive~     Tamoxifen given concurrently with radiotherapy while in Arm 2 radiotherapy will be given~     followed by tamoxifen sequentially. The patients will be stratified for the following~     factors: a) BCS (Breast conservative surgery) versus MRM (modified radical mastectomy) and b)~     central lung distance (CLD) > 2 cm.~      Patients in both arms will continue tamoxifen for a period of 5 years. The patients will be~     evaluated by high-resolution computed tomography (HRCT) (baseline and at 2 years), serum~     transforming growth factor (TGF) beta levels (baseline and at 6 months) and~     diethylenetriaminepentaacetic acid (DTPA) aerosol clearance half life (baseline and at 6~     months).~   "
203651|NCT00896142|"~     To evaluate the impact of left ventricular (LV) lead location on LV mechanical function.~   "
203652|NCT00896129|"~     Rationale: At present, virtually no evidence exists regarding mid to long-term~     patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients~     treated with Imatinib.~      Purpose: the results of this research will provide preliminary evidence-based data on an~     number of issues from the patients' perspective, including adherence to therapy issues.~   "
203653|NCT00896090|"~     This study is being done to determine whether measures of brain activity (known as cortical~     excitability and inhibition) collected by Transcranial Magnetic Stimulation (TMS) are~     different in children and adolescents with depression and children and adolescents that do~     not have depression.~   "
203654|NCT00896077|"~     Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Autoimmune diseases happen when the~     immune system does not identify part of the body as belonging to it. The immune system then~     destroys that part as if it were an unknown tissue in the body. In T1DM, the body kills the~     cells in the pancreas that produce insulin. Insulin is the hormone that unlocks the cells~     of the body. It allows glucose to enter and fuel them. Special cells in the body called~     islets make the insulin. Since glucose cannot enter the cells, it builds up in the blood. The~     body's cells literally starve to death. Children are at risk of developing T1DM and the risk~     is much higher than other severe, chronic childhood diseases. The only treatments are a~     careful diet, planned physical activity, and testing blood sugar levels several times a day.~     The patient must also inject insulin each day or use an insulin pump. There is no cure for~     T1DM. Insulin injections are considered life support, because going without insulin for just~     a few days causes the blood to have too much acid in it and that can lead to death. On the~     other hand, taking too much insulin makes blood sugar levels go too low, and if untreated,~     can lead to death as well.~      DiaKine is developing Lisofylline to treat the failed immune system. This is what caused T1DM~     in the first place and it does not go away. The purpose of this study is to see how safe the~     study drug is. The study is also going to compare the levels of study drug in the blood and~     to measure the effect of the study drug on other substances in the blood that are linked to~     type 1 diabetes. These levels will be measured after the study drug is given as an injection~     under the skin and an injection into the vein. To date, Lisofylline has been tested when~     given as an injection in the vein.~      The investigators hypothesize that Lisofylline will be safe when given as an injection under~     the skin and in the vein and that levels of study drug will be very similar when given as an~     injection under the skin and in the vein.~      The investigators also hypothesize that Lisofylline will have a positive effect on the~     substances in the blood that are linked to type 1 diabetes.~   "
203655|NCT00896064|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a~     booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT 00707798)~   "
203656|NCT00896051|"~     The purpose of this study is to determine the pharmacokinetics (how the body absorbs,~     distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1~     NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and~     anti-HIV effect of this regimen will also be studied. A total of 46 patients will be~     enrolled.~   "
203657|NCT00896038|"~     Objective:~      Alcoholism is highly co-morbid with post traumatic stress disorder (PTSD). Since stress and~     negative affective states are major relapse triggering factors for alcohol use, the negative~     symptoms associated with PTSD are thought to promote alcohol dependence. Substance P, which~     is released in the amygdala in response to stress, acts at NK1 receptors (NK1Rs) to mediate~     behavioral stress responses. Blockade of the NK1R represents a novel approach for anti-stress~     actions. In a recent double blind, placebo controlled study involving detoxified anxious~     alcoholics, we found that NK1R antagonism decreased alcohol cravings, attenuated cortisol~     response to stress, and significantly decreased insula activation in response to negative~     sensory input. The present study is intended to expand the findings and determine whether the~     NK1R is a candidate target for treating alcohol dependent patients with PTSD.~      Study Population:~      On hundred twenty participants with PTSD and co-morbid alcohol dependence will be recruited~     and stratified by PTSD etiology (60 participants each with civilian and combat PTSD, resp).~     Within each stratum, the treatment groups will be balanced for sex using urn randomization.~     Stratification is indicated since civilian and combat-related PTSD can theoretically have a~     different pathophysiology. Civilians typically experience a single trauma exposure of~     invariably high magnitude, resulting in symptoms immediately. Combat-related PTSD typically~     results from multiple traumatic exposures over a prolonged period of time, of variable~     magnitude, and frequently with delayed emergence of symptoms.~      Design:~      Participants will be admitted to the National Institute on Alcohol Abuse and Alcoholism~     (NIAAA) research inpatient unit at the NIH Clinical Research Center (CRC) under protocol~     number 05-AA-0121 for assessment and treatment of people with alcohol drinking problems,~     which provides diagnostic assessments and standard withdrawal treatment if needed.~     Participants will enter into the present protocol once such treatment, if needed is~     completed. Following inclusion, all participants will receive 1 week of single blind placebo,~     and will then be randomized to double blind treatment with aprepitant or placebo. Randomized~     treatment will be for 3 weeks. Spontaneous cravings for alcohol, and ratings of~     psychopathology will be obtained twice weekly on the inpatient unit throughout the study.~     Cravings as well as endocrine and immune responses will also be assessed in a challenge~     session that combines a social stressor and exposure to physical alcohol cues. During the~     final week, three sessions utilizing scripts will be carried out, on separate days in~     counter-balanced order, exposing the participant to personalized trauma, alcohol-associated~     or neutral stimuli. Cravings as well as endocrine and immune responses will also be assessed~     during the script presentations. A functional magnetic resonance imaging (fMRI) session will~     be carried out last to assess responses to affective stimuli. Participants will remain~     hospitalized throughout the study, and will remain on the unit for a three day~     post-medication monitoring period.~      Outcome Measures:~      The primary outcome will be craving alcohol and changes in PTSD symptoms resulting from the~     script sessions. Secondary outcomes will include cravings and changes in PTSD symptoms~     resulting from the combined social stress-alcohol cure challenge session, spontaneous craving~     and PTSD symptoms during hospitalization, and brain responses on the fMRI session. Changes in~     PTSD symptoms and cravings for alcohol are intended to be surrogate markers for the overall~     effect of the drug treatment and are not intended to represent global improvement for either~     PTSD or alcoholism.~   "
203658|NCT00896025|"~     This proposed study is a multi-center open label study to determine if N-acetylcysteine has~     any survival benefits in patients with ALF.~   "
203659|NCT00896012|"~     Current therapy to prevent organ rejection relies on the use of calcineurin inhibitors either~     cyclosporine or tacrolimus. Although these agents have been very successful in preventing~     early acute rejection, this success has not translated into improved long-term kidney~     transplant function. One of the important factors that leads to premature kidney transplant~     failure is chronic allograft nephropathy (CAN). CAN is characterized by progressive~     interstitial fibrosis or scarring, vascular wall thickening, and finally glomerular~     sclerosis leading to slow progressive loss of kidney function. Calcineurin inhibitors have~     been shown to play an important role in the pathogens of CAN. Renal transplant recipients in~     whom calcineurin inhibitors are discontinued enjoy better and longer kidney function.~     Therefore, immunosuppressive strategies are being designed with the intention of withdrawing~     calcineurin inhibitors.~      The purpose of this trial is to test if tacrolimus can be safely substituted by sirolimus~     (Rapamycin) and this substitution will yield improved renal function, less CAN and better~     graft survival rates over the first year.~   "
203660|NCT00895999|"~     Patients with depression and pain have poorer outcomes in response to depression treatments~     than depressed patients without pain. While psychotherapy treatment studies have demonstrated~     improvement in pain and depression, no psychosocial interventions have been developed and~     tested prospectively specifically for patients with both conditions. Interpersonal~     psychotherapy (IPT), an effective treatment for depression, has been adapted successfully for~     physically ill patients and demonstrates good adherence, treatment satisfaction, and~     depression outcomes. The investigators propose to test a modified form of IPT-P for depressed~     patients with co-morbid pain.~   "
203661|NCT00895986|"~     Many people with type 2 diabetes are not able to keep their blood glucose in good control.~     Improving blood glucose control and maintaining that improvement is important for diabetes~     patients because doing so delays the onset and progression of severe complications of~     diabetes. Although educational programs may be helpful, their effect is not always~     long-lasting. This project is studying whether the Conversation Maps program (an interactive~     diabetes education program) reinforces diabetes education and information and thus helps type~     2 diabetes patients take better care of their diabetes and blood glucose levels. Half of the~     patients will attend the Conversation Maps program and half of the patients will attend an~     educational program about blood pressure and cholesterol. Also, all patients will come in for~     4 or 5 appointments to complete surveys and other tests and have their blood drawn. The group~     of patients who attend the Conversation Maps program will be compared to the group of~     patients who attend the blood pressure and cholesterol program to see if the educational~     programs helped diabetes patients to improve their diabetes control and quality of life and~     to maintain that improvement over time.~   "
206400|NCT00859716|"~     The purpose of this study is to determine whether ACE393 vaccination can protect against~     Campylobacteriosis in a challenge model.~   "
203663|NCT00895960|"~     Phase I:~      Primary Objectives:~      -To define the maximum tolerated dose (MTD) of dasatinib (Sprycel) with radiotherapy (RT) and~     6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m^2/day in patients with~     newly-diagnosed glioblastoma (GBM).~      Secondary Objectives:~        -  To characterize the safety profile of dasatinib (Sprycel) in combination with~          radiotherapy (RT) and concomitant TMZ in patients with newly-diagnosed GBM.~        -  To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant~          TMZ in patients with glioblastoma after RT.~      STUDY DID NOT PROGRESS TO PHASE II PORTION.~      Phase II:~      Primary Objectives:~      -To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of~     concomitant temozolomide (TMZ) administered at 75 mg/m^2/day followed by adjuvant~     temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM) as~     measured by overall survival.~      Secondary Objectives:~        -  To determine the efficacy of this treatment as measured by radiographic response (RR),~          progression-free survival (PFS) and time to progression (TTP).~        -  To characterize the safety profile of dasatinib (Sprycel) in combination with RT and~          concomitant TMZ in patients with newly-diagnosed GBM.~        -  To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant~          TMZ in patients with GBM after RT.~      Exploratory Objectives:~      -To correlate tumor genotype, tumor expression of dasatinib target proteins (e.g. Src, EphA2,~     c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and temozolomide.~   "
203664|NCT00895947|"~     The aim of the study is to see if lozenges containing a low dose of interferon-alpha can~     prevent and/or reduce the severity of colds and flu. Starting about 1 month before the~     expected start of the winter colds and flu season in Perth, Australia, healthy volunteers~     will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo),~     to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of~     treatment will determine whether interferon was able to prevent infections with cold/flu~     viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms,~     medications taken, days of work missed, etc. to see if interferon was able to make their~     winter colds and flu less severe.~   "
203665|NCT00895934|"~     The purpose of this study is to test the safety of vorinostat (Zolinza) and azacitidine~     (Vidaza) when combined with gemtuzumab ozogamicin (GO) at different dose levels. These drugs~     increase the effect of GO against leukemia cells in the test tube, but we don't know yet~     whether they also increase the anti-leukemia effect of GO in people.~   "
203666|NCT00895921|"~     This study will examine the effects of two different antipsychotic medications on control of~     blood sugar in people who are at risk of diabetes but mentally healthy.~   "
203667|NCT00895908|"~     This study will determine the effectiveness of an intervention for preventing at-risk~     kindergarten and pre-kindergarten children from developing attention deficit hyperactivity~     disorder.~   "
203668|NCT00895895|"~     The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at~     three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531,~     donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive~     placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the~     remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage~     levels or donepezil in period I will continue with the same study drug (period II).~   "
203669|NCT00895882|"~     This study will evaluate the safety, tolerability, and efficacy of vaniprevir when~     administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat~     treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.~   "
203670|NCT00895869|"~     Retinopathy of prematurity screening is painful. Wide field digital retinal imaging (WFDRI)~     and binocular indirect ophthalmoscopy (BIO) are being used for screening examinations. The~     aim of Edinburgh, UK based study is to compare the pain experienced by infants using both~     examination techniques.~   "
203671|NCT00895856|"~     Getting old is a process of transformation of the body that occurs along the vital cycle in a~     universal and progressive way causing functional restrictions in the human being. The aim of~     this work was to identify, analyze and quantify the limitations of the functional capacity of~     the institutionalized elderly who are not provided with physiotherapic assistance.~   "
203672|NCT00895843|"~     The purpose of this study is to investigate whether robust analgesic regime (protective~     analgesia) can improve postoperative pain experience for patients undergoing lower wisdom~     teeth extraction under day case general anaesthetic.~   "
203673|NCT00895830|"~     To assess the efficacy and safety of different doses of APD405 in the prevention of~     post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV.~     Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any~     surgical technique), cholecystectomy (any surgical technique) or other elective surgery~     scheduled to last at least one hour from induction of anaesthesia), requiring at least one~     overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past~     history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use~     for post-operative analgesia.~   "
203687|NCT00895648|"~     Despite the best surgical efforts, complete removal of mesothelioma is possible in~     approximately 30% of the patients. When surgical removal is complete, chemotherapy followed~     by radiation therapy is recommended as an effort to improve control over the cancer and~     survival. This combination of treatments is called TRIMODALITY therapy. Unfortunately, the~     chances for the tumor coming back after TRIMODALITY therapy remains high. When surgical~     removal is not complete or not possible, some patients may receive chemo and/or radiation~     therapy to achieve control over the cancer, but the chances of tumor to growth again remains~     high and the chances of long term survival remains low.~      The combination of Pemetrexed (Alimta) with Cisplatin has been approved as one of the~     standard chemotherapy drug combinations for the treatment in advanced Malignant Pleural~     Mesothelioma, and there is likely a group of patients who may benefit and potentially be~     cured by this therapy. In an effort to achieve a better chance of complete removal of the~     cancer and long term survival, the investigators are interested in using this drug~     combination of Pemetrexed + Cisplatin before surgery and offer radiation therapy after~     surgery.~   "
204237|NCT00888355|"~     The study had a 4 week single blind placebo period followed by 12 weeks of double blind~     treatment. Patients were randomized to one of four treatment arms to evaluate the~     antihypertensive efficacy of Losartan.~   "
203674|NCT00895817|"~     The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in~     comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis~     (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and~     food impaction. The presence of anatomical abnormalities in the esophagus such as~     longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are~     classic endoscopic findings. Diagnosis is established with the histologic finding of large~     numbers (> 15) of eosinophils per high power field. The underlying pathologic mechanism~     remains poorly understood but food allergies and aeroallergens have been implicated. It is~     well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but~     it is unclear whether a complex relationship exists between GERD and EE, as recent data~     suggests. Furthermore, a large number of patients with clinical presentations and endoscopic~     findings highly suggestive of EE which is confirmed on histology are responding favorably to~     proton pump inhibitors.~      The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed~     Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine~     whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis,~     (3) determine the number of patients with eosinophilic esophagitis that have coexisting~     gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement~     in symptoms before and after therapy.~   "
203675|NCT00895804|"~     MDMA (3,4-Methylenedioxymethamphetamine, Ecstasy) produces tachycardia, hypertension,~     hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare~     cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of~     cardiovascular and adverse effects of MDMA is unknown.~   "
203676|NCT00895791|"~     The aim of this study is to compare vessel healing at 9 months using OCT imaging for two~     different treatment techniques for treating bifurcation lesions. Quantitative assessment of~     OCT images will be used to assess re-endothelialization and quality of strut apposition to~     the vessel wall.~   "
203677|NCT00895778|"~     This study is designed to test the clinical hypothesis that a neuromuscular block improves~     surgical conditions, operation time, and post-operative pain.~   "
203678|NCT00895765|"~     The purpose of this study is to investigate the lesions, clinical features and outcome in~     young children with melamine-related-calculus.~   "
203679|NCT00895752|"~     The purpose of this study is to investigate the effectiveness and tolerability of riluzole in~     adults with Fragile X Syndrome.~   "
203680|NCT00895739|"~     RATIONALE: Immunosuppressive therapies, such as alemtuzumab and cyclosporine, may improve~     bone marrow function and increase blood cell counts. Giving alemtuzumab together with~     cyclosporine may be an effective treatment for severe aplastic anemia or acquired marrow~     failure.~      PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with~     cyclosporine and to see how well it works in treating patients with severe aplastic anemia or~     acquired marrow failure.~   "
203681|NCT00895726|"~     Primary Objective:~      To assess the efficacy of APD209 in adult patients with active cachexia associated with~     advanced malignancy and not caused by simple starvation.~      Secondary Objective:~      To assess the safety of APD209 in patients with advanced malignancy and active cachexia.~   "
203682|NCT00895713|"~     The purpose of this study is to determine if treatment with intramuscular hepatitis B virus~     immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe~     for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation.~   "
203683|NCT00895700|"~     The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but~     a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral~     intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD~     patients, which may be equally effective and have advantages over more traditional forms of~     therapy, due to its low-threshold accessibility via the internet.~      The purpose of this study is to determine whether patients receiving a behavioral~     intervention via the internet experience less anxiety and device concerns and improved~     quality of life compared to patients receiving usual care.~   "
203684|NCT00895687|"~     The goal of this clinical research study is to find the highest tolerable dose of Tarceva~     (erlotinib hydrochloride) that can safely be given in combination with Velcade (bortezomib).~     The safety of this drug combination will also be studied.~   "
203685|NCT00895674|"~     Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer~     type, which means that patients who present with an advanced disease have a rather poor~     prognosis. When this study has been started the standard therapy for patients has been~     cytokines, which might be accompanied by significant toxicities or might fail the therapeutic~     goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional~     study has been created and is being conducted to collect clinical data on the patients'~     therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses~     on patient characteristics and tumor status in RCC treated with sorafenib as well as the~     treatment duration and safety of sorafenib under everyday treatment conditions.~   "
203686|NCT00895661|"~     The purpose of this clinical trial is to see if increased doses of rituximab are safe and~     effective for the initial treatment of indolent B-cell lymphomas. Rituximab (Rituxan) is a~     type of drug called an antibody that specifically targets B-cell lymphoma cells, and is~     approved by the FDA for the treatment of indolent B-cell non-hodgkin lymphomas and certain~     other types of non-hodgkin lymphomas. Standard doses currently used may not be achieving~     maximal efficacy. Higher doses have been shown to be safe in other clinical trials, and may~     offer superior efficacy to the current standard dose. This trial also employs intermittent~     maintenance doses of rituximab at the standard dose, which has been shown to prolong~     remissions and survival in patients with relapsed indolent B-cell lymphomas. This trial is~     designed to show that higher dose rituximab plus maintenance rituximab can achieve similarly~     good results to chemotherapy approaches, but without chemotherapy-related toxicity.~   "
203688|NCT00895635|"~     Peripheral arterial disease (PAD) is a disorder that affects more than 8 million people in~     the United States. As a result of decreased blood flow to the legs, people with PAD may~     experience leg pain and difficulty with walking. This study will examine the effectiveness of~     two exercise programs—a treadmill walking program and an aerobic arm exercise program—at~     increasing walking distance and decreasing leg pain in people with PAD.~   "
203689|NCT00895622|"~     RATIONALE: Sometimes a tumor may not need treatment until it progresses. In this case,~     observation may be sufficient. Specialized radiation therapy that delivers a high dose of~     radiation directly to the tumor, such as 3-dimensional conformal radiation therapy and~     intensity-modulated radiation therapy, may kill more tumor cells and cause less damage to~     normal tissue. It is not yet known whether observation is more effective than radiation~     therapy in treating patients with meningioma.~      PURPOSE: This phase II trial is studying observation to see how well it works compared with~     radiation therapy in treating patients with grade I, grade II, or grade III meningioma.~   "
203690|NCT00895609|"~     This study is designed to compare recovery times after reversal of a residual neuromuscular~     block (TOF-ratio 0.5) with different doses of either neostigmine or sugammadex.~   "
203691|NCT00895596|"~     The purpose of the study is to investigate the safety and the antiviral activity of ascending~     multiple oral doses of LB80380 for 12 weeks in adults with lamivudine-refractory chronic~     hepatitis B infection.~   "
203692|NCT00895583|"~     This study will look at the effect on long-term kidney function using tacrolimus right after~     a transplant and then switching to sirolimus at 3 to 5 months after the transplant.~   "
203693|NCT00895570|"~     The purpose of the study is to examine the effects of sleep and modafinil on how the body~     processes glucose.~   "
203694|NCT00895557|"~     Our proposal will enable us to study cocaine patients to determine whether varenicline can~     weaken brain arousal to drug cues in an fMRI imaging setting, which is what we theorize. This~     supplement supports a pilot imaging study in cocaine dependence. It will evaluate the impact~     of varenicline on the brain response to ultra-brief drug and comparison cues in an~     event-related fMRI paradigm. This is a pilot study.~      We will additionally examine the impact of varenicline on addiction-relevant behavioral~     probes of impulsivity, inhibition, attentional and affective bias. The proposed study will~     provide the first brain-behavioral probes of varenicline's cocaine-relevant actions in~     humans, and will provide the critical scientific rationale to move the agent into future~     collaborative clinical trials.~   "
203695|NCT00895544|"~     The main objective of the study is to assess the immune response to a non-adjuvanted H5N1~     influenza vaccine in an adult population when administered according to a single prime-boost~     schedule.~   "
203696|NCT00895531|"~     The investigators hypothesize that patients who receive a femoral catheter with low dose~     epidural Depodur will experience comparable or superior pain relief than those who receive~     both femoral and sciatic catheters. In addition, the investigators hypothesize that the one~     catheter will be less time consuming to place and facilitate early ambulation of the patient.~   "
203697|NCT00895518|"~     This study will examine the use of prolonged exposure therapy on people who have recently~     experienced a trauma to prevent them from developing post-traumatic stress disorder.~   "
203698|NCT00895505|"~     This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully~     used to tailor the duration of OAT in patients after an unprovoked episode of deep venous~     thrombosis (DVT) using a prospective, randomized, and controlled design.~   "
203699|NCT00895492|"~     The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes~     associated with moderate to severe disease (requiring emergency room (ER) consult or~     hospitalization) in a large public hospital from Valparaiso and another from Santiago.~   "
203700|NCT00895479|"~     Patients in renal failure on hemodialysis depend on adequate and sustained vascular access.~     This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE)~     graft. These patients frequently experience graft complications arising from the development~     of smooth muscle cell (SMC) neointimal hyperplasia in the proximity of the graft-vein~     anastomosis. Such complications eventually lead to stenosis, access thrombosis and graft~     failure. Trinam® is being developed to prolong graft survival. It is a combination product~     consisting of a replication deficient Adenovirus containing the human Vascular Endothelial~     Growth Factor D (Ad-VEGF-D) gene and a biodegradable local delivery device (collar) made of~     collagen. At the end of the surgical procedure to insert the PTFE graft the collagen collar~     is applied around the anastomosis and sealed with a collagen surgical sealant. This procedure~     creates a reservoir between the site of anastomosis and the collagen collar. The adenoviral~     vector is then injected into this reservoir, localizing the expression of the transgene to~     the site of the anastomosis. Expression of VEGF-D has been shown to have a vascular~     protective role and inhibit SMC neointimal proliferation, therefore expression of VEGF-D~     should prolong graft survival.~   "
203701|NCT00895466|"~     The purpose of this trial is to investigate whether treatment with this new drug will result~     in lower testosterone levels in men with prostate cancer. At the same time it will be~     investigated whether the drug induces side effects, and if so, which ones.~   "
203702|NCT00895453|"~     A prospective study to evaluate the efficacy of classic homeopathic therapy compared to~     maintenance itraconazole therapy with and without additional exogenous lactobacillus for~     treatment of recurrent Candida vaginitis.~   "
203703|NCT00895440|"~     Diabetes mellitus can result in damage to the nerves supplying the feet. Various tests can be~     used to assess nerve damage but no tests so far have been used to assess loss of sweating~     which can lead to dry skin, fissuring and ulceration. The indicator test (Neuropad) is a~     plaster which is applied to the sole of the feet just below the 1st and 2nd toes of both~     feet. If the color of the plaster changes to pink it indicates that there is no nerve damage~     to the nerves. However if the plaster retains the blue color or the color only partially~     changes to pink after 600 seconds then this is a positive test and the patient has nerve~     damage.~   "
203704|NCT00895427|"~     This study examines the relationship between the SCOUT DM device and coronary artery~     calcification as determined by rapid computed tomography in patients at risk for coronary~     heart disease.~   "
203705|NCT00895414|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Enalapril maleate may help protect heart cells from the side effects of~     chemotherapy. It is not yet known whether giving enalapril maleate before or after~     doxorubicin hydrochloride is more effective in treating women with breast cancer.~      PURPOSE: This randomized clinical trial is studying giving enalapril maleate together with~     doxorubicin hydrochloride to see how well it works in treating women with breast cancer.~   "
203706|NCT00895401|"~     This is a Phase IV randomized controlled study assessing the effectiveness of a commercially~     available nutritional supplement on malnourished prevalent hemodialysis patients. Patients~     will be randomized to either receive one can of Nepro with Carb Steady at each dialysis~     treatment for 6 months or to receive the standard of care counseling for malnutrition. The~     primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate~     an improvement in albumin levels with oral nutritional supplement provided in-center thrice~     weekly in addition to standard of care as compared to malnourished maintenance hemodialysis~     patients provided standard of care alone.~   "
203707|NCT00895388|"~     Quality of life after rectal surgery is reported to be impaired. Side effects of surgery~     and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary~     incontinence, anal incontinence or stoma problems are commonly experienced. The investigators~     hypotheses is that structured rehabilitation program addressing these problems will improve~     quality of life. A RCT are performed in order to document the effects of the rehabilitation.~   "
203708|NCT00895375|"~     The purpose of this study is to compare the sleep quality of patients with psoriasis to~     patients without psoriasis.~   "
203709|NCT00895362|"~     The goal of this clinical research study is to find the highest tolerable dose of Tarceva~     (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab).~     The safety of this drug combination will also be studied.~   "
203710|NCT00895349|"~     The purpose of this trial is to improve the clinical management and outcome of patients with~     locally advanced cervical cancer by using positron emission tomography-computed tomography~     (PET-CT) imaging.~      There is considerable debate worldwide regarding the utility of PET for staging cervical~     cancer. Although there are studies on the accuracy (sensitivity and specificity) of PET in~     cervical cancer, there are currently no prospective randomized studies on how PET information~     affects treatment decisions and outcomes.~   "
203711|NCT00895336|"~     Abstract:~      Current evidence suggests that the enteric flora is the primary trigger for chronic mucosal~     inflammation in the Inflammatory Bowel Diseases (IBD), Crohn's Disease (CD) and Ulcerative~     Colitis (UC). Studies using probiotic administration to modify the flora for either induction~     or maintenance of remission in IBD have had mixed results. Whether probiotics may exert an~     anti-inflammatory effect in IBD is not known. The investigators hypothesize that daily~     administration of a probiotic, Lactobacillus GG, for four weeks will reduce objective markers~     of mucosal inflammation in pediatric UC patients. The investigators will enroll 20 UC~     patients in remission or with mild disease activity. These patients will have a one month~     period of observation without intervention. They will then receive Lactobacillus GG~     (Culturelle), 1010 CFU by mouth twice a day for four weeks (28 days). At baseline and Day 28,~     and at day 56 clinical disease activity will be measured using the Pediatric UC Activity~     Index (PUCAI), a blood sample for determination of circulating granulocyte pSTAT3+ activation~     will be obtained, and a stool sample for determination of fecal calprotectin will be~     obtained. In addition, =the investigators will sample subject saliva to determine salivary~     glycan phenotype as a surrogate marker of changes of mucosal glycan expression in response to~     probiotic administration. The investigators anticipate that both circulating granulocyte~     pSTAT3+ activation and fecal calprotectin, as established biomarkers of colonic inflammation,~     will be reduced in subjects who receive Lactobacillus GG. Completion of the proposed studies~     will determine whether Lactobacillus GG reduces mucosal inflammation in pediatric UC, and~     will provide information to design a larger randomized trial.~      The investigators' study design is novel in that it is the first probiotic study in children~     with UC and it will measure outcomes utilizing the biomarkers fecal calprotectin and pSTAT3+~     circulating granulocytes.~   "
203712|NCT00895323|"~     RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may~     help find colorectal cancer cells and learn the extent of disease.~      PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor~     cells in patients with colorectal cancer.~   "
203713|NCT00895310|"~     The purpose of this study is to test the safety of ketoconazole and how well it works after~     chemotherapy has been used. Ketoconazole at lower doses has been used for fungal infections~     however has not yet been approved by the Food and Drug Administration for use in prostate~     cancer. Ketoconazole has been used for many years at high doses for prostate cancer, and this~     study will be to look at use of lower dose ketoconazole after someone has received~     chemotherapy. Ketoconazole works by halting the production of steroids in your body,~     including testosterone, and is thought to work directly on prostate cancer cells in published~     lab studies.~   "
203714|NCT00895297|"~     This is a phase II efficacy (indicates the capacity for beneficial change or therapeutic~     effect) and safety study of Dasatinib in patients with relapsed Chronic Myeloid Leukemia~     (CML) following a Stem Cell Transplant (SCT) and who are not benefiting from other treatment,~     such as imatinib therapy.~      A relapse is when an illness that has seemed to be getting better, or to have been cured,~     comes back or gets worse again.~      A total of 50 patients ≥18 years of age will be registered on the trial.~   "
203715|NCT00895284|"~     Robotic technology has been used for laparoscopic hysterectomies for over 10 years. Mayo~     Clinic Arizona has used robotics in Gynecology for the last 10 years with well over 500~     procedures performed. Similar to the laparoscopic approach, small incisions are utilized with~     the robotic approach. Robotic instruments differ from laparoscopic instruments in that the~     tips of the instruments can rotate more like the human wrist. The instruments are attached to~     the robotic arms which are controlled by your surgeon. The surgeon is seated at the surgeon's~     console which is located 12 feet from the patient while the surgical assistant is at your~     bedside assisting in the procedure.~      This study is being done to compare the procedure times and results after laparoscopic~     hysterectomies to laparoscopic hysterectomies performed with robotic assistance.~   "
203729|NCT00895102|"~     The purpose of this study is to determine the bioavailability, pharmacokinetic and safety~     profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy~     volunteers.~   "
203730|NCT00895089|"~     This clinical trial compares the use of moxifloxacin versus ceftriaxone in the treatment of~     primary pyogenic liver abscess. The trial will include nonpregnant adults presenting with~     primary liver abscess based on clinical diagnosis and computed tomography. The trial aims to~     determine whether the use of moxifloxacin can effectively treat primary pyogenic liver~     abscess and shorten hospitalization. This regimen has the additional benefit of avoiding~     nephrotoxic agents, such as aminoglycosides, used frequently in treatment of pyogenic liver~     abscess. Development of antibiotic resistance to colonized bacteria in the gastrointestinal~     tract will also be evaluated using stool cultures.~   "
203731|NCT00895076|"~     The primary objectives are to evaluate the extent of systemic exposure and dexamethasone~     bioavailability following a single application of a dexamethasone iontophoretic transdermal~     patch in healthy volunteers.~      The secondary objectives are to evaluate the systemic and topical safety of the dexamethasone~     iontophoretic transdermal patch and of the dexamethasone intramuscular (IM) injection.~   "
203716|NCT00895271|"~     Background:~        -  National Institutes of Health (NIH) researchers have been studying immune cells (white~          blood cells) to better understand how the human body s defense system works and adjusts~          or regulates itself, and how changes in this system can make a person sick.~        -  To study the cells of patients who have problems with their immune systems, researchers~          would like to collect samples of skin cells from patients with immune system disorders~          and compare them with skin cells taken from healthy volunteers. By studying these cells,~          researchers hope to determine whether these cells can be modified to create a new kind~          of personalized gene therapy that would attempt to cure immune diseases in the future.~      Objectives:~        -  To obtain skin cells from patients with immune system disorders and from healthy~          volunteers for research and comparison purposes.~      Eligibility:~        -  Patients between the ages of 2 and 85 who have immune system disorders.~        -  Healthy volunteers between the ages of 18 and 85.~        -  Both groups will be selected from the eligible participants of existing NIH studies into~          immune system disorders.~      Design:~        -  Researchers may take up to two biopsies from participants arms, legs, abdomen, or back.~        -  The biopsy site will be numbed with local anesthetic and cleaned before the sample is~          taken.~        -  The punch skin biopsy needle will be inserted into the skin and rotated to remove a~          small circle of skin (approximately 1/4 to 3/8 of an inch across). The area will be~          closed with bandages or stitches, and then covered with a dressing. Any stitches will be~          removed in 7 to 10 days.~        -  Tissue samples collected in the study will be stored for future research.~   "
203717|NCT00895258|"~     This study will compare the efficacy of two types of supportive treatments for a program~     called Individual Placement and Support, which helps people with severe mental illnesses find~     and keep jobs.~   "
203718|NCT00895245|"~     RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help~     lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck~     cancer undergoing chemotherapy and radiation therapy.~      PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine together with~     palonosetron hydrochloride and dexamethasone works in preventing nausea and vomiting caused~     by cisplatin in patients with stage III or stage IV head and neck cancer undergoing~     chemotherapy and radiation therapy.~   "
203719|NCT00895232|"~     Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS~     were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron~     sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The~     second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over~     four to six hours on two separate dates, separated by two to seven days. The third cohort~     received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within~     30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.~   "
203720|NCT00895219|"~     Traditionally, the physiotherapy management of people with dysfunctional breathing or~     hyperventilation syndrome is breathing re-training. There is increasing clinical evidence~     that structural and functional changes develop in the muscles and connective tissues of the~     chest wall, abdomen and back when the upper chest accessory pattern of breathing is used over~     time. When treatment includes breathing techniques only it is difficult for a person with~     chronic hyperventilation, who has developed muscle and connective tissue changes, to revert~     to using the normal lower chest diaphragmatic breathing pattern. In clinical practice when~     the problems which have developed in the musculoskeletal system are addressed, the patient~     reverts more quickly to the lower chest pattern of breathing but there is as yet little~     evidence to support this clinical finding.~   "
203721|NCT00895206|"~     This study is an open, randomised trial in which one group of patients (control) will receive~     the golden standard therapy and the other group (treatment) will receive individually adapted~     immunosuppression.~   "
203722|NCT00895193|"~     Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However,~     use of niacin is limited due to incidents of flushing which limits its acceptability. Some~     information suggests that applesauce can reduce the incidence and severity of flushing. The~     apple pectin in particular is thought to be the ingredient that affects this reaction. To~     determine if the apple pectin does affect flushing from niacin, the investigators will study~     the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100~     patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into~     4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo.~     Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.~   "
203723|NCT00895180|"~     RATIONALE: Monoclonal antibodies, such as ramucirumab and anti-PDGFR alpha monoclonal~     antibody IMC-3G3 (Olaratumab), can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying how well ramucirumab or anti-PDGFR alpha monoclonal~     antibody IMC-3G3 works in treating patients with recurrent glioblastoma multiforme.~   "
203724|NCT00895167|"~     Heme oxygenase 1 (HO-1) serves as a protective gene. Induction of HO-1 has therapeutic~     potential for several indications. The inducibility of HO-1 by curcumin will be evaluated in~     this pilot study. Furthermore, the influence of a modulating factor of HO-1 gene activity on~     the dinucleotide guanosine thymine repeat (GT) length polymorphism in the promotor region~     will be investigated.~   "
203725|NCT00895154|"~     The overall goal of this project is to determine the feasibility of conducting a cognitive~     intervention for children with sickle cell disease.~   "
203726|NCT00895141|"~     The purpose of the study is to test whether increased saturated fat intake results in~     increased levels of larger LDL and HDL particles in individuals with LDL Pattern B.~   "
203727|NCT00895128|"~     The goal of this clinical research study is to find the highest tolerable dose of Tarceva~     (erlotinib hydrochloride) that can be given in combination with Sprycel (dasatinib). The~     safety of this drug combination will also be studied.~   "
203728|NCT00895115|"~     RATIONALE: Vitamin E supplements may stop or delay the development of prostate cancer in~     patients who are at risk of prostate cancer or who have prostate cancer. It is not yet known~     which vitamin E regimen is more effective in preventing prostate cancer.~      PURPOSE: This randomized phase I trial is comparing vitamin E supplement regimens to see how~     well they work in preventing cancer in patients at risk of prostate cancer or who have~     prostate cancer.~   "
203732|NCT00895063|"~     Studies have suggested that voluntary muscle exercise in the hand and face after botulinum~     toxin injection may enhance the clinical effects of the toxin. Exercise may speed up the~     absorption of the toxin by the nerves and enhance the clinical response. This study will~     explore the effect of exercise on botulinum toxin injections for spasmodic dysphonia (SD).~   "
203733|NCT00895050|"~     The primary purpose of this study is to evaluate a computer-based tool on the clinical~     management of patients with rheumatoid arthritis in Spain.~   "
203734|NCT00895037|"~     The purpose of this observational study is to describe the incidence of adverse events among~     patients treated with Refacto AF in usual health care settings in Germany and Austria.~   "
203735|NCT00895024|"~     The Objectives are to administer the Family Evaluation of Hospice Care (FEHC) questionnaire~     and The Texas Revised Inventory of Grief (TRIG) to caregivers previously enrolled into the~     parent grant and conduct supplemental analyses to:~        1. examine cross-ethnic differences in the caregivers' quality of hospice care assessments.~        2. investigate the association between parenteral hydration status of the patient and the~          quality of care assessments provided by the caregivers after death.~        3. examine the association between levels of grief (as measured by the TRIG) and the~          quality of hospice care assessments provided by the caregiver.~   "
203736|NCT00895011|"~     The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil~     in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing~     radical prostatectomy.~   "
203737|NCT00894998|"~     The objective of this study is to verify, through a randomized, single-blind, multicentre,~     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in~     patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through~     the control of hemostasis during and after surgery, based on the strengths of markers of~     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)~     at the end of the surgery.~   "
203738|NCT00894985|"~     The objective of this study is to verify, through a randomized, open, multicentre, parallel~     and comparative study, the effectiveness of heparin sodium of porcine origin in patients~     undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the~     control of hemostasis during and after surgery, based on the strengths of markers of~     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)~     at the end of the surgery.~   "
203739|NCT00894972|"~     The proposed study will be a randomized clinical trial designed to determine the most~     effective physical therapy program for individuals who have undergone lumbar discectomy~     surgery. The study will compare two different post-operative physical therapy programs~     (general strengthening or general + specific strengthening). Both groups will begin treatment~     2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8~     weeks with a treatment program emphasizing exercises shown to activate the large trunk~     muscles without imposing potentially harmful compression or shear forces. The general +~     specific strengthening group will also receive exercises shown to isolate activation of the~     deep trunk muscles, in particular the multifidus, with training augmented by the use of~     diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and~     post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.~   "
203740|NCT00894959|"~     The objective of this study is verify, through a randomized, single-blind, multicentre,~     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in~     patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through~     the control of hemostasis during and after surgery, based on the strengths of markers of~     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)~     at the end of the surgery.~   "
203741|NCT00894946|"~     The hypothesis of this study is that Lipiodol uterine bathing improves the success rate of in~     vitro fertilization (IVF) for women with endometriosis or recurrent IVF implantation failure.~   "
203742|NCT00894933|"~     1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and~          complications associated with the Device following a radical prostatectomy.~        2. To verify CONTINUUM™ device performance using updated CONTINUUM™ device design~          modifications, physician procedure guide and training methodology.~   "
203743|NCT00894920|"~     The purpose of this study is to estimate the number of pregnant women who, during pregnancy,~     have low levels of the vitamin biotin. The hypothesis of this study is that a large number of~     pregnant women will have low biotin levels. This information will be used to later determine~     if low biotin levels during pregnancy cause certain birth defects.~   "
203744|NCT00894907|"~     Acute pancreatitis (AP) is a common disorder with rising incidence varying between 35 and 80~     per 100,000 in Europe and the USA. About 15% of patients develop necrotizing pancreatitis~     (NP) with a mortality of up to 42% and frequently prolonged hospitalisation in the survivors.~     Despite a fulminant pathophysiology comparable to that of sepsis, the management of NP is~     still re-active, symptomatic and mainly based on paradigms with low grade evidence. In sepsis~     beneficial effects of early goal-directed fluid resuscitation resulting in reduced mortality~     have been clearly shown. With regard to these data and several studies of NP demonstrating~     the deleterious effects of fluid loss and haemoconcentration within the first 24h after~     admission, early goal-directed fluid resuscitation has the potential of improving outcome~     also in NP. Therefore, it is the aim of this RCT to demonstrate beneficial effects of early~     goal-directed resuscitation using an algorithm based on modern haemodynamic parameters such~     as Intra-thoracic Blood Volume Index (ITBI), Extravascular Lung Water Index (ELWI) and Stroke~     Volume Variation (SVV) which can be easily and safely obtained due to recent progress in~     haemodynamic monitoring. The algorithm is aimed at maintaining adequate resuscitation (ITBI,~     SVV) as well as preventing pulmonary over-hydration (ELWI).The use of a similar algorithm in~     cardiac surgery patients resulted in a significant reduction in catecholamine use, lactate~     levels, duration of ventilation and ICU stay.~   "
203745|NCT00894894|"~     Multicenter, open-label, dose-ranging study in two parts: maximum tolerated dose (MTD)~     segment (the first 28-day course of MP 470) followed by long-term safety segment.~      MTD segment: follows standard oncology phase-I design; within-patient dose level adjustments~     prohibited; each patient participates in one of three stages:~        1. Accelerated Titration Stage~        2. Dose Escalation/De-Escalation Stage~        3. Dose Confirmation Stage~   "
203748|NCT00894855|"~     This study was an evaluation of the Dana-Farber Cancer Institute Blum Family Resource Center~     Van's existing skin cancer screening and education program. This program occurred over 2~     summers. This study will fill a critical gap in the investigators' knowledge about how best~     to address the high-risk behaviors that regularly occur during the summertime at beaches. The~     investigators randomized beaches to receive different combinations of the van program~     components in order to determine how services should optimally be configured to maximize~     impact. The investigators hypothesized that providing all three components (1-Skin cancer~     prevention education; 2-Biometric feedback using a Dermascan Analyzer that illustrates skin~     damage due to sun exposure and Ultra Violet (UV) Reflectance Photography; and 3-Dermatologist~     skin exam) will maximize knowledge and behavior change, relative to education alone.~   "
203749|NCT00894842|"~     The purpose of this study is to determine whether pregnenolone will demonstrate significant~     improvements in cognitive functioning and negative symptoms compared to patients receiving~     placebo.~   "
203750|NCT00894829|"~     The objective of this study is to verify, through a randomized, single-blind, multicentre,~     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in~     patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through~     the control of hemostasis during and after surgery, based on the strengths of markers of~     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)~     at the end of the surgery.~   "
203751|NCT00894816|"~     During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic~     disease were recruited and randomized to daily intake of cereals with or without the addition~     of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age.~     The effects of LF19 on gut microbial composition, infections, allergies, immunological~     development, growth and blood lipids were monitored. Of 179 included infants, 171 completed~     the study. The study product was well tolerated with no observed side effects. Compliance was~     excellent.~      In a follow-up study, the aim is to investigate the long-term effects of feeding LF19 during~     weaning on allergies, immune programming, overweight, gut microbial composition and oral~     health in 8-year old children.~      The investigators' primary outcome will be to determine whether daily intake of LF19 during~     weaning results in less eczema at 8 years of age, and if the preventive effect encompasses~     also respiratory allergies and immunoglobulin E (IgE) - sensitization. The long term effects~     on gut microbial composition, overweight and metabolic markers will be investigated.~     Furthermore, the possible preventive effects of LF19 on caries will be assessed.~   "
203752|NCT00894803|"~     The primary goal of this trial is to determine if individuals with acute ischemic stroke~     treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of symptom~     onset are more likely to have a better outcome than individuals treated with standard IV~     rt-PA alone.~   "
203753|NCT00894790|"~     This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In~     Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident~   "
203754|NCT00894777|"~     This is an observational, naturalistic, multicenter, retrospective study to describe the~     therapeutic management of patients with moderate and severe psoriasis under treatment with~     topical and/or systemic drugs in usual clinical practice in Spain.~   "
203755|NCT00894764|"~     This study will follow 1000 refugee infants from birth for two years. The aim of the study is~     to better understand why some children develop infections caused by the bacterium~     Streptococcus pneumoniae whilst others merely carry this organism asymptomatically at the~     back of the nose (in the nasopharynx). The investigators will also define which~     micro-organisms cause lower respiratory tract infections (e.g., pneumonia) in this population~     in order to implement appropriate interventions (e.g., vaccines). Infants will be reviewed~     monthly and a nasopharyngeal swab will be taken. A group of 250 mother-infant pairs will be~     studied in greater detail, to improve our understanding of the frequency and outcomes of~     nasopharyngeal carriage of Streptococcus pneumoniae. Monthly nasopharyngeal swabs will be~     collected from mothers and infants. The investigators will measure the infant immune response~     to Streptococcus pneumoniae carriage or disease by taking monthly blood samples. The~     investigators will make an assessment of the protective effect of antibodies acquired from~     the mother during pregnancy by taking blood from the mother and placenta at birth. An~     assessment of pneumococcal carriage in mothers will also be made to determine how frequently~     the bacterium is transmitted between family members. All lower respiratory tract infections~     will be documented, and the causative micro-organisms identified.~   "
203756|NCT00894751|"~     The goal of this study is to determine if there is a significant difference in the quality of~     care between the investigators' two standard anesthesia techniques for children undergoing a~     MRI of the body and/or extremity MRI. Quality of care will be measured by time spent in the~     MRI room as well as parental satisfaction, frequency of interruptions of the MRI scan,~     incidence-severity of respiratory complications, post anesthesia agitation, and time spent in~     the induction room, MRI room, and Post-Anesthesia Care Unit (PACU).~   "
203757|NCT00894738|"~     The proposed study aims to begin the multi-step process of establishing the reliability and~     validity of hepatic triglyceride content (HTGC) and carotid artery intima-media thickness~     (IMT) as biomarkers of cardiometablic risk in children treated for mental illness. The~     distribution of HTGC and carotid IMT—proximate indicators of cardiometabolic risk—across a~     range of dual-energy X-ray absorptiometry (DEXA)-measured adiposity in children treated with~     antipsychotic agents will be characterized in comparison to healthy, untreated,~     non-psychiatric controls, in order to estimate effect sizes for future studies incorporating~     these markers. The ability of HTGC and IMT to predict cardiometabolic risk as measured by~     commonly-used laboratory tests, such as fasting lipids, liver function tests, C-reactive~     protein and serum fibrinogen, will be assessed.~   "
203758|NCT00894725|"~     The main goal of this study is to clarify if laparoscopy (LPS) could become the standard~     approach in patients undergoing left colonic resection.~      268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or~     open (n=134) approach. Postoperative care protocol was the same in both groups. Trained~     members of the surgical staff who were not involved in the study registered 30-day~     postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term~     morbidity, quality of life, and 5-year survival have also been evaluated.~   "
203759|NCT00894712|"~     The investigators plan to investigate the protective effects of topical~     sulforaphane-containing broccoli-sprout extracts (BSE) on radiation-induced dermatitis in~     women undergoing external-beam radiation therapy for breast cancer. Topical sulforaphane~     induces phase 2 enzymes that are protective against oxidants, electrophiles, and inflammation~     (Talalay and Fahey, 2001) - all of which are generated by both ultraviolet and ionizing~     radiation. Previous work from the investigators' group demonstrated that sulforaphane~     treatment protects against ultraviolet radiation-induced erythema of human skin (IRB protocol~     NA_00004897; Talalay et al. 2007). This investigation will extend the investigators' previous~     work by employing ionizing rather than ultraviolet radiation.~      The investigators propose a two part sequential protocol (Study A and Study B). Both studies~     will involve women with breast cancer who have undergone lumpectomy and are scheduled for~     adjuvant external beam radiation treatment. In study A, the investigators will validate their~     technique for measurement of skin erythema using a device called a chromometer; no active~     agent will be applied (up to 6 women). Study B will follow completion of Study A. Study B~     will involve the application of broccoli sprout extracts (BSE) or vehicle alone to determine~     if sulforaphane can reduce radiation-induced erythema (27 women). Four adjacent, 1.5-cm~     diameter areas-of-interest on the affected breast will be located by means of an adhesive~     vinyl template which can be accurately and repeatedly placed at the same position. Two of the~     four areas will be treated with BSE (active agent) and two with vehicle (inactive control).~     BSE will be applied on three days weekly throughout the 5-week period of whole breast~     radiation. Erythema will be noninvasively quantified by measuring the red-reflectance of the~     skin with a chromometer up to three times weekly throughout treatment. A total of 33 patients~     are to be enrolled.~      The investigators' objective is to determine and quantify the effect of topical BSE on~     radiation-induced skin erythema. This study will employ standard, clinically-accepted~     radiation doses and techniques that are safe and well tolerated. The safety and tolerability~     of both oral and topical broccoli sprout preparations is well established; no safety concerns~     have been noted. (Shapiro et al. 2006; Dinkova-Kostova et al. 2007).~   "
203760|NCT00894699|"~     The purpose of this study is to evaluate the safety and effectiveness of a study medication~     that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This~     drug is being designed to provide mild sedation as well as reduce anxiety and pain before and~     during a procedure (in this case elective abdominal liposuction).~   "
203761|NCT00894686|"~     The main purpose of this study is to assess the seropersistence of TBE virus antibodies in~     children, adolescents and young adults who received the first booster vaccination with either~     FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.~   "
203762|NCT00894673|"~     The objective of this study is to verify, through a randomized, single-blind, multicentre,~     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in~     patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through~     the control of hemostasis during and after surgery, based on the strengths of markers of~     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)~     at the end of the surgery.~   "
203763|NCT00894660|"~     The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is~     pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).~   "
203764|NCT00894647|"~     The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus~     placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).~   "
203765|NCT00894634|"~     The objective of this study is to characterize the pharmacokinetic (PK) profile of~     brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years~     following dosing in accordance with current weight-age dosing guidelines. Once characterized,~     the PK data will be pooled with adult PK data from other studies and analyzed under a~     separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12~     yrs and adolescents aged 12 to <18 yrs.~   "
203766|NCT00894621|"~     The purpose of this study is to assess the effectiveness from early infusion of~     norepinephrine in pediatric patients submitted to mechanical ventilation for the use of~     sedative and analgesics drugs.~   "
203767|NCT00894608|"~     The purpose of this study is to determine whether letrozole combined with gonadotropins are~     effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS.~   "
203768|NCT00894595|"~     Football-related knee injuries are common and especially the anterior cruciate ligament (ACL)~     injury constitute a serious problem in football regardless of the playing level. The purpose~     of this study is to conduct a randomized controlled trial evaluating the effect of a training~     program designed to prevent acute knee injury in female adolescent football players.~      The investigators' hypotheses are:~        1. a preventive training program reduces the incidence of ACL injury, and~        2. a high match frequency and match play at senior level increase the risk of ACL injury.~   "
203769|NCT00894582|"~     Immediate post-operative abdominal compartment syndrome is a feared complication after hernia~     repair in patients with a loss of abdominal domain. Replacement of the viscera within an~     unyielding stiff abdominal wall may compromise the perfusion of the intestines, elevate the~     diaphragm, and interfere with ventilation. The components separation technique, used to~     repair these massive hernias, employs bilateral relaxing incisions in the external oblique~     muscle and fascia in order to approximate the rectus abdominis muscles in the midline.~     Reducing a large volume hernia into the abdominal cavity and primary closure of the abdominal~     wall should cause problems both with abdominal compartment pressure and with postoperative~     ventilation, but in the investigators' 13-year experience with over 250 cases, this has not~     been seen clinically, and the investigators sought to understand why. The investigators'~     hypothesis is that releasing the rectus muscles from the external obliques expands the~     intra-abdominal compartment, reclaims lost domain, and thus reduces abdominal pressure and~     respiratory problems. The investigators have previously reported increased abdominal volumes~     using the components separation technique in a retrospective series, but patients were not~     standardized for the collection of data, and no pulmonary function tests were obtained in~     that series (Hadad, in press). The purpose of this study was to prospectively analyze the~     effect of this surgical technique on abdominal volume and pulmonary function.~   "
203770|NCT00894569|"~     The purpose of this study is to determine whether an addition of cetuximab to~     carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in~     patients with carcinoma of unknown-primary.~   "
203771|NCT00894556|"~     A study to provide evidence supporting the benefit of Rizatriptan in patients who have an~     inadequate response to sumatriptan.~   "
203772|NCT00894543|"~     The purpose of this study is to test whether a medication reduces the number, severity and~     bothersomeness of menopausal hot flashes. Escitalopram (also called Lexapro®) is a selective~     serotonin reuptake inhibitor (SSRI). It is sold by prescription for depression and general~     anxiety disorder. An SSRI increases serotonin, a brain substance that is believed to~     influence mood. Serotonin may also affect brain levels of estradiol, a hormone related to hot~     flashes. This research study will test whether escitalopram reduces menopausal hot flashes.~   "
203775|NCT00894504|"~     In this Phase II trial, the investigators will evaluate the combination of gemcitabine,~     carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative~     breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be~     examined for the presence of various markers, including K-ras and PI3K-activating mutations,~     EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a~     patient subset that is particularly responsive to treatment with a panitumumab-containing~     combination.~   "
203776|NCT00894491|"~     Patient survey identifying key elements of patient experience and decision-making processes~     regarding attendance University of California, Irvine (UCI)'s Integrative Medicine Clinic.~   "
203777|NCT00894478|"~     Focal cortical dysplasia is one of the most common lesions responsible for medically~     refractory epilepsy in the pediatric population. In patients with medically intractable~     epilepsy, surgery is the only treatment that will lead to seizure freedom. The outcome of~     epilepsy surgery is worse in patients when there is no lesion identified on routine~     structural MRI, also known as MRI-negative partial epilepsy. Diffusion tensor imaging (DTI),~     a novel MRI technique, can be used to evaluate the integrity of the microstructure of the~     white matter, even when the white matter appears normal on routine MRI.~   "
203778|NCT00894465|"~     The purpose of this research is to validate the common administration of oral midazolam to~     children prior to voiding cystourethrogram (VCUG) to see if this will significantly decrease~     children's anxiety and make the experience less traumatic.~   "
203779|NCT00894452|"~     The purpose of this study is to describe clinical, pharmacokinetic and genetic factors~     associated with the variance of oral methadone dosage for patients at the steady state of~     heroin dependence maintenance treatment. The hypothesis is that the investigators can predict~     70% of the variance with few factors, including CYP 3A4 function measured with oral midazolam~     challenge.~   "
203780|NCT00894439|"~     The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given~     together to healthy subjects.~   "
203781|NCT00894426|"~     The aim of this study is to assess the perception of chronic obstructive pulmonary disease~     (COPD) patients in symptoms related to morning activities. Also the researchers investigated~     how to describe the impact of symptoms on sleep quality and how to use the medication in~     Korea COPD treatments.~   "
203782|NCT00894413|"~     The purpose of this trial is to determine whether or not Cialis (tadalafil) administered to~     head and neck squamous cell cancer patients augments immune response.~   "
203783|NCT00894400|"~     The purpose of this study is to characterise which fractionated electrogram morphologies are~     important to target in the catheter ablation of atrial fibrillation.~   "
203784|NCT00894387|"~     This study evaluated the effect of early initiation of aliskiren therapy, compared to~     standard therapy, in the reduction of cardiovascular death and heart failure~     re-hospitalization events within 6 months, in congestive heart failure (CHF) patients~     hospitalized for an episode of acute decompensated heart failure.~   "
203785|NCT00894374|"~     The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is~     pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).~   "
203786|NCT00894361|"~     This study will be designed to compare prospectively, in a randomized fashion, the clinical,~     functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing~     posterior cruciate substituting design with a modular posterior cruciate substituting~     rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will~     afford the investigators information in the following areas:~        1. Does a RP design offer improvement in range of motion over a AP design?~        2. Does a RP design have improved wear characteristics over a nonmodular AP design?~        3. Is there a clear clinical advantage to the RP design that justifies its increased cost?~      Answering these questions will allow surgeons to use RP designs appropriately in different~     demand populations.~      This study was designed to address the questions of whether an RP design offers improvement~     in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of~     Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short~     Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators'~     primary hypothesis was that there would be no difference in these outcome measures at a~     minimum two year followup. A secondary hypothesis based on the anticipated long-term followup~     of this group was that there would be no difference in implant survival.~   "
203787|NCT00894348|"~     To determine factors associated with a positive yield of malignancy on biliary brush cytology~     obtained by ERCP.~   "
203788|NCT00894335|"~     This study is a prospective, perioperative evaluation of hemodynamic and respiratory~     parameters in patients undergoing retroperitoneoscopic adrenalectomies.~   "
203789|NCT00894322|"~     This study is designed to evaluate the pharmacokinetics, tolerability, and safety of~     exenatide once weekly suspension in both healthy subjects and in subjects with type 2~     diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development~     of this exenatide once weekly presentation would eliminate the need to reconstitute the~     product prior to use.~   "
203800|NCT00894179|"~     Purpose: The investigators plan to test a newly FDA approved pharmacologic stress agent,~     Regadenoson, in conjunction with atropine in the use of stress echocardiography for the~     diagnosis of coronary artery disease. The selective nature of Regadenoson allows for its use~     in patients with contraindications to the currently used drug, Adenosine, which is~     non-selective. Furthermore, the proposed protocol can be completed faster and without~     radiation exposure than the current protocol with adenosine.~      Design: This is a prospective study evaluating people with no prior diagnosis of coronary~     disease with a prior stress test and are scheduled for cardiac catheterization. Patients who~     meet inclusion criteria will undergo regadenoson-atropine echocardiography protocol prior to~     their catheterization. The study will be interpreted by two independent readers blinded to~     the catheterization results. The sensitivity, specificity, positive and negative predictive~     values of the regadenoson-atropine study will be then be calculated using the coronary~     angiogram as a gold standard.~   "
203895|NCT00892918|"~     The purpose of this study is to determine whether there is a difference in corneal epithelial~     healing rate and/or toxicity following pterygium excision, between eyes treated~     post-operatively by moxifloxacin(VIGAMOX)versus gatifloxacin (ZYMAR).~   "
203790|NCT00894309|"~     Fluid therapy is an important part of the management of patients with hemodynamic instability~     in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac~     output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive.~     By contrast, volume administration can be deleterious in terms of pulmonary edema formation~     or other manifestations or fluid overload, especially in patients who are not preload~     responsive. Functional dynamic parameters that use heart-lung interactions, such as pulse~     pressure variation (PPV) and stroke volume variation (SVV) are considered accurate predictors~     of preload responsiveness in patients receiving fully controlled mechanical ventilation.~      However, in cases of spontaneous breathing activity where heart-lung interaction indices fail~     to predict fluid responsiveness, one needs parameters able to reliably predict the~     hemodynamic response of fluid administration.~      A new index that could indicate fluid responsiveness, so-called the fluid responsiveness~     index (FRI), has been elaborated. The advantage is that it could be used in patients who are~     not in control mechanical ventilation as well as in patients who are fully adapted to~     mechanical ventilation.~      The FRI is based upon the analysis of continuous arterial and continuous central venous~     pressure. The FRI is determined by the relation of cardiac and respiratory activity; both are~     evaluated by means of power spectrum analysis of the pressures recorded.~      The aim of this study is to test the value of the FRI to predict the hemodynamic response to~     fluid infusion in patients with hemodynamic instability not receiving fully controlled~     mechanical ventilation.~   "
203791|NCT00894296|"~     The objective of the suggested study is to identify changes in MEG correlates caused by the~     add-on treatment with the changes in negative symptoms of schizophrenia by comparing the~     change in the MEG correlates of the subjects before and during usage of new add on treatments~     for negative symptoms.~      The investigators hypothesize that the gravity of negative symptoms will correlate with a~     trend towards more aberrant electroencephalographic correlates mainly in continuous~     parameters, with an emphasis on alpha and delta bands~   "
203792|NCT00894283|"~     This pilot study is designed to determine the feasibility of conducting a randomized clinical~     trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice~     daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after~     bariatric surgery in obese patients.~   "
203793|NCT00894270|"~     Children and adolescents with type 1 diabetes mellitus are required to inject insulin daily.~     The injection technique should reliably deposit insulin into subcutaneous fat while~     minimizing inadvertent delivery into either the skin or the underlying muscle, both of which~     are associated with suboptimal outcomes. The use of shorter, thinner needles reduces the~     incidence of intramuscular delivery and is associated with reduced discomfort, but increases~     the risks of both shallow (intradermal) delivery and of loss of insulin through backflow to~     the skin surface.~      In the current study, 240 subjects (children and adults) will receive multiple injections of~     small volumes of sterile air in the thigh and abdomen using 5 mm Novofine® needles, to~     simulate insulin injections performed at the two sites using various injection techniques~     (perpendicular or angled needle, with or without skin fold). Ultrasound visualisation of the~     injected air will allow determination of the incidence of intradermal or intramuscular~     delivery using the various delivery methods in the trial. In addition, adult subjects will~     receive injections of a liquid test medium in order to determine the incidence and extent of~     backflow. Qualitative data on perceived discomfort and information on body composition will~     also be collected. This investigation will form the basis for recommendations regarding~     preferred injection technique where 5 mm needles are used.~   "
203794|NCT00894257|"~     According to the centres taking part in the ALHICE survey, the number of HIV-HCV co-infected~     women is currently decreasing. This drop was first noted in 2006 and persisted in 2007. What~     might have been considered a chance phenomenon during the first year (2006) was confirmed in~     the beginning of 2008. In view of this information, the investigators wished to ascertain the~     reality of this trend and to investigate its causes, by attempting to answer the following~     questions: - Has the prevalence of risk factors for HCV infection changed among the general~     population over the past 10 years?~        -  Has the prevalence of risk factors for HCV infection changed among HIV/HCV co-infected~          women over the past 10 years?~        -  Is the change in the number of co-infected women who gave birth during the past 10 years~          related to the prevalence of certain risk factors among this population?~        -  Is the change in the number of co-infected women who gave birth during the past 10 years~          related to a decrease in certain risk factors for HCV infection among the general~          population?~        -  Have changes in addictive behaviour among women of child-bearing age played a role in~          the decreasing number of HCV-contaminated children? Furthermore, follow-up data from~          HCV-infected children born during this period will provide information concerning the~          course of HCV infection.~      The objectives are to study trends in numbers of deliveries among HCV/HIV co-infected women~     as well as trends in risk factors for HCV infection among women of child bearing age and~     lastly to create a cohort of HCV infected children.~   "
203795|NCT00894244|"~     This study is being done to measure the amount of skin shrinkage caused by a non-invasive~     skin tightening device.~   "
203796|NCT00894231|"~     The purpose of this study is to noninvasively measure the anti-inflammatory effect of~     levocetirizine after two weeks of treatment in allergic rhinitis subjects.~   "
203797|NCT00894218|"~     Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at~     patients suffering from degenerative osteoarthritis of these articulations with medium and~     long-term good results. The main objective of this study is to compare the efficiency in~     short and medium-term functional impact parlance of two surgical techniques:~     computer-assisted surgery and mini-invasive surgery compared to the conventional techniques~     thanks to an innovative technology of ambulatory analysis of walking.~   "
203798|NCT00894205|"~     This study aims to examine the benefits to thinking processes of a low intensity,~     strengthening exercise program for older adults.~   "
203799|NCT00894192|"~     The purpose of this study is to assess the level of visual functioning in patients with~     various eye conditions while wearing different types of eyeglasses.~   "
203896|NCT00892905|"~     The purpose of this study is determine the agreement of point of care (POC) clotting tests~     (INR and aPTT) by the POC device by Hemochron Jr versus standard laboratory clotting tests~     (INR and aPTT) in patients undergoing elective cardiac surgery.~   "
203801|NCT00894166|"~     Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation~     treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit~     from prescription treatment alternatives, including Zyban or Chantix. In this study, the~     investigators propose to develop and evaluate a stepped-care treatment algorithm that would~     evaluate whether smokers who receive treatment with NRT should be supplemented with Zyban or~     switched to Chantix only based on: 1) their initial response to NRT; and 2) individual~     genetic factors found to predict smoking cessation in other studies evaluating these~     treatments. This study is a continuation of our previous studies showing that abstinence~     rates can be increased by starting nicotine patch therapy two weeks before the quit date. The~     investigators will provide pre-cessation NRT to all participants initially. Those who do not~     show a favorable response on early indicators of success (e.g., smoking in the first week~     after the target quit-smoking date) will receive rescue treatment by having their NRT~     treatment supplemented with Zyban , by being switched to treatment with Chantix or will~     remain on NRT (control).~      The investigators hypothesize that Rescue treatment with Zyban in combination with NRT or~     Chantix will increase success rates over leaving subjects on NRT when they are NRT~     insufficient responders, i.e. they have shown an unfavorable response to NRT in the first~     week pre-quit or the first week post-quit.~   "
203802|NCT00894153|"~     This is multicenter, open-label, randomized, active-controled, phase IV study of local direct~     intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , with concurrent~     radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in~     advanced stage .~   "
203803|NCT00894140|"~     The purpose of this study is to determine if the Silent™ hip, when used as part of an~     artificial hip joint, is stable and effective in treatment of patients with joint disease~     requiring a total hip replacement. Patients who enter the study will be evaluated at regular~     intervals following hip surgery using patient, clinical, standard and special x-rays (RSA) to~     allow the position of the Silent Hip within the bone to be accurately monitored.~   "
203804|NCT00894127|"~     Primary Objective:~        -  To determine the clinical sensitivity and specificity of the Biomoda CyPath™ Early Lung~          Cancer Detection Assay using sputum specimens from two cohorts of participants and~          estimate the required sample size to finalize a protocol for a pivotal study.~      Secondary Objectives:~        -  To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay in a~          clinical setting to identify cancer cells, as assessed by TCPP labeled cancer cells~          demonstrating red fluorescence under a microscope with ultraviolet (UV) light being~          observed with a FITC (Fluorescein isothiocyanate) Filter.~        -  To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay to~          detect pre-invasive cancer in comparison with PAP sputum cytology and routine CT scan.~   "
203805|NCT00894114|"~     This study is designed to determine whether patients previously primed with Ad5 of MRKAd5~     HIV-1 gag vaccine respond better when boosted with ALVAC-HIV vaccine than when boosted with~     MKRAd5 HIV-1 gag vaccine.~   "
203806|NCT00894101|"~     The purpose of this study is to investigate the clinical value of serial quantitative [F-18]~     FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with~     radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard~     [F-18] FDG PET will be the active comparator.~   "
203807|NCT00894088|"~     The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg~     tablets under fasted conditions.~   "
203808|NCT00894075|"~     This Clinical Trial is being conducted to study Hypophosphatasia (HPP), a bone disorder~     caused by gene mutations or changes. These gene mutations cause low levels of an enzyme~     needed to harden bone. The purpose of this study is to test the safety of the study drug~     called ENB-0040 and see what effects is has on human juveniles and HPP.~   "
203809|NCT00894062|"~     Stent thrombosis is an important issue in drug eluting stents. Incomplete endothelial~     coverage and neointimal coverage over strut after drug eluting stent (DES) implantation could~     be a possible cause of stent thrombosis. Therefore, theoretically dual antiplatelet therapy~     should be continued to prevent the stent thrombosis until complete reendothelialization. But,~     detection of endothelial coverage over stent is not possible with the available intravascular~     devices in clinical practice. Among currently available intravascular devices, intravascular~     optical coherence tomography (OCT) could give a more clear identification for a thin layer of~     neointima with high-resolution (10-20 μm) compared to intravascular ultrasound (100-150 μm).~     Previous OCT studies showed the significant different pattern of neointimal coverage between~     bare metal stent (BMS) and DES. In the investigators' experience, there were also some~     differences in neointimal coverage among the DESs, especially zotarolimus eluting stent~     (ZES). ZES has been known to be associated with significantly more neointimal coverage than~     SES at 8 months intravascular ultrasound (IVUS). Both everolimus eluting stent (EES) and ZES~     resolute were recently introduced. The efficacy to suppress the neointimal growth for ZES~     resolute and EES might be improved, but safety for neointimal coverage needs to evaluate in~     human coronary artery. Therefore, this study will investigate the pattern of neointimal~     coverage over stent in ZES resolute and EES at 9 months after stent implantation.~   "
203810|NCT00894049|"~     This study is a prospective comparison between 2 popular regimens based on reduced intensity~     or non-myeloablative approaches to define the optimal myeloablative and/or~     immu-nonsuppressive association for reduced intensity conditionings (RIC).~      Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2~     days) and Thymoglobuline (2.5 mg/m²/1day).~      Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation~     (TBI).~      A randomization of 2 phase study according to the methodology developed by Liu et al (Liu,~     1993 and 2001) for the evaluation of multiple innovative approaches.~      Primary endpoint is one year overall survival (OS). Stopping rules included excessive~     engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an~     independent safety review board (ISRB).~      Inclusion criteria are patients presenting a hematological malignancy, eligible for non~     myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable~     HLA identical sibling. All patients and donors are included after giving written informed~     consent.~      Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular~     therapies committee (national agency).~   "
203811|NCT00894036|"~     Objectives:~      The aim of the study is to determine the molecular epidemiology and genetic variability of~     ESBL-producing enterobacteriaceae (E-ESBL) among children in Switzerland and to estimate the~     associated clinical burden of disease.~      The investigators' hypotheses are:~        1. The genetic variability (and especially the distribution of strains harbouring the CTX-M~          genes) among children is similar to that observed in adults;~        2. The overall burden of disease is still low in Switzerland compared to neighbouring~          countries. However, treatment of severe E-ESBL infections is challenging;~        3. The recommended oral treatment procedure with 3rd generation cephalosporins for febrile~          urinary tract infection may contribute to increased prevalence of E-ESBL in the long~          term.~      The study is scheduled to start July 1st, 2008, and end June 30th, 2010.~   "
203812|NCT00894023|"~     Background: Percutaneous coronary intervention (PCI) is a highly effective therapy for acute~     ST-elevation myocardial infarction (STEMI). Adjunctive therapy with glycoprotein (GP)~     IIb/IIIa inhibitor can result in increased patency and improved outcomes in STEMI patients,~     with thrombus, undergoing PCI. The investigation of novel dosing and delivery strategies of~     this therapy may help to further improve outcomes.~      Study design: Intracoronary Abciximab With Clearway Catheter trial is a randomized,~     open-label, multicenter, trial to evaluate the effect of an intracoronary (IC) bolus dose of~     abciximab delivered using the ClearWay™RX catheter versus an intravenous bolus (IV) of~     abciximab for STEMI with angiographically visible thrombus (Thrombus Grade > 2). All patients~     in both arms will receive intravenous abciximab infusion following the PCI for 12 hours per~     standard practice. A total of 150 patients will be randomized 1:1 to treatment of the culprit~     artery with IC abciximab (75 subjects) or IV abciximab (75 subjects) in addition to an~     infusion regimen of abciximab administered intravenously and initiated following PCI. The~     primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on Cardiac~     Magnetic Resonance (CMR). Clinical outcomes will be assessed for each subject through~     hospital discharge and at 30 day follow-up.~      Sample size: The number of patients included in this study was based on the estimation of the~     sample size needed to identify a statistically significant difference of the primary~     end-points between the two groups. The investigators estimated that 75 patients would be~     required in each study group to have a power of 80% to detect an absolute difference in the~     infarct size resolution of 15% with a two-sided alpha value of 0.05.~      Conclusion: The purpose of this study is to demonstrate that an IC bolus of abciximab~     delivered with the ClearWay™RX catheter added to a post-PCI intravenous infusion regimen of~     abciximab will result in significant additional clot resolution in vivo when compared with an~     IV bolus of abciximab when added to a post PCI intravenous infusion regimen of abciximab. The~     primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on CMR.~   "
203813|NCT00894010|"~     The purpose of this study is to determine whether patients who usually have abnormal~     electrical EEG responses when shown flashing lights will show a reduction in abnormal~     electrical activity when they take a single dose of 2 marketed drugs (carbamazepine and~     levetiracetam). If so, a similar study in the future may be able to identify promising new~     drugs for epilepsy.~      Patients who successfully complete the screening visit, will return 4 additional times and~     will receive either placebo (2 times) or a single oral dose of both carbamazepine 400mg and~     levetiracetam 1000mg in random order.~      During each of the study days, several procedures and intermittent photosensitivity (IPS)~     assessments will be performed at 5 pre-determined times over the course of the day, one~     pre-dose and 4 post-dose.~   "
203814|NCT00893997|"~     Primary aim:~        1. To determine the immunologic response, using a PR1-HLA-A2 tetramer assay, to 4~          subcutaneous (SQ) injections of TVC-PR1 vaccine formulated in Montanide ISA 51 VG~          followed by granulocyte macrophage colony-stimulating factor (GM-CSF) in low risk and~          intermediate-1 myelodysplastic syndrome (MDS) patients.~      Secondary aims:~        1. To determine if non-immunologic responders to 4 subcutaneous (SQ) injections of TVCPR1~          vaccine formulated in Montanide ISA 51 VG followed by GM-CSF can be converted to~          immunologic responders by administering 4 additional doses of TVC-PR1 vaccine formulated~          in Montanide ISA 51 VG followed by GM-CSF.~        2. To determine the clinical response to 4 or 8 subcutaneous (SQ) injections of TVC-PR1~          vaccine formulated in Montanide ISA 51 VG followed by GM-CSF in patients low risk and~          intermediate-1 MDS.~   "
203815|NCT00893984|"~     In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in~     cardiovascular patients who are not able to tolerate conventional beta blockers. A side~     effect profile will be tracked and compared with previous beta blocker use.~      The investigators hypothesize that Bystolic will be tolerated by many patients who are~     intolerant of conventional blockers.~   "
203816|NCT00893971|"~     The purpose of this study is to evaluate the safety of a single dose of PT003 compared with~     single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two~     separate single doses in healthy subjects.~   "
203817|NCT00893958|"~     The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg~     tablets under fed conditions.~   "
203818|NCT00893945|"~     This study involves cancer research and the purpose is to assess the safety and activity of a~     type of vaccine as immune therapy for cancer.~      This vaccine will be made from each participant's own immune cells (called dendritic cells)~     obtained by blood donation. Dendritic cells (DCs) are immune cells whose role is to identify~     foreign material in the body (such as bacteria, viruses, or tumor cells).~      When DCs recognize this material, they use it to activate other cells of the immune system to~     mount an attack against that foreign material. In the Laboratory of Molecular Neuro-Oncology,~     each participant's DCs will be loaded with samples of their own tumor cells that were~     obtained at surgical resection. These tumor cells are killed in the laboratory using a~     special protocol, and then fed to the DCs. The DCs eat this material, and these fed DCs~     make up the vaccine.~   "
203819|NCT00893932|"~     Leptin is a hormone that plays a central role in food intake and energy balance. It is~     secreted by fat cells, released into the circulation and transported into the central nervous~     system (brain), where it regulates energy balance and food intake. The overall effects of~     leptin appear to reduce food intake when the body is calorically satisfied, and to alter~     metabolic rate A decrease in the amount of body fat, which occurs after fasting, reduces the~     level of leptin, thereby stimulating food intake. Systemic Inflammation is a condition in~     which body tissues respond to stress. It may be associated with severe infection or other~     stimuli such as trauma, and may lead to organ failure and death. It has been shown, that~     Leptin may be a survival protein, where higher levels are associated with lower mortality.~     The investigators set out to quantify the levels of Leptin in critically ill patients in~     association with other markers of inflammation and mortality.~   "
203820|NCT00893919|"~     The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg~     Capsules under fed conditions.~   "
203926|NCT00892489|"~     The purpose of this study is to evaluate the bioequivalence between the Phase 3 and the~     to-be-marketed formulations of extended release (ER) OROS paliperidone and to evaluate the~     effect of food on the highest to be marketed tablet strength. Additionally, the safety and~     tolerability of the treatments in healthy volunteers will be assessed.~   "
203821|NCT00893906|"~     Influenza, a highly communicable acute respiratory disease, is one of the major infectious~     disease threats to the human population. In Africa, information on the occurrence of~     influenza and its disease burden is seriously lacking. Such data would be important in~     determining the contribution of influenza to the more than two million annual pneumonia~     deaths among children globally, mostly in the developing world, and the potential number of~     deaths that could be prevented by influenza vaccination.~      A single dose of trivalent inactivated influenza vaccine (TIV) is 70 to 90 percent effective~     in preventing influenza in healthy older children and young and middle-aged adults, but is~     less efficacious in young children and the elderly. Young children who suffer substantial~     influenza morbidity and are unlikely to have pre-existing immunity should receive two doses~     of TIV to provide adequate immunity. Because family studies of influenza transmission~     conducted during the 1970's found children to be the main introducers of influenza into~     households, vaccination of children may decrease the chances of spreading influenza to~     contacts. Mass vaccination of schoolchildren has been correlated with reduced respiratory~     illness in unvaccinated persons suggesting that immunization of children on a larger scale~     can affect community epidemics.~      In temperate industrialized countries with seasonal disease, influenza vaccine is given~     annually, prior to the influenza season, and generally targeted to individuals with the~     highest risk of severe disease. Influenza prevention strategies may need to differ in~     tropical developing countries due to a variety of reasons. Given the varying influenza~     circulation patterns, it is unknown which hemisphere vaccine formulation will provide~     year-round protection against the diverse strains that may exist in tropical countries.~     Persons residing in developing countries also may have nutritional deficiencies or underlying~     diseases and infections that affect vaccine immunogenicity. Consideration must be given to~     programmatic issues as well. Adolescent and adult preventive health services are poorly~     developed in many countries, and thus a strategy that targets children may be the most~     feasible option. In addition, vaccinating children may be the most cost-effective option, as~     it has the potential to provide direct benefit to those vaccinated, as well as indirect~     benefits to unvaccinated members of the population. Thus, an influenza vaccine effectiveness~     study in a tropical developing country population will help to elucidate burden of seasonal~     influenza and may inform optimal use of vaccine for either seasonal and pandemic situations.~      Thus, this study in Senegal will to evaluate the direct effects of TIV in reducing the~     occurrence of laboratory-confirmed influenza among children who receive it as well as the~     potential indirect effects experienced by the population as a result of reducing transmission~     among children.~   "
203822|NCT00893893|"~     Purpose:~      To investigate the uptake of VLDL-TG in visceral fat in lean and overweight individuals~   "
203823|NCT00893880|"~     A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat~     moderate to severe tinea pedis.~   "
203824|NCT00893867|"~     The purpose of this trial is to determine if intravenous administration of the metal ion~     trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3~     additional days (4 consecutive days in total) is effective in improving long term outcome.~     Patients will be followed up for 3 months after the stroke.~   "
203825|NCT00893854|"~     Cystoids macular edema (CME) is one of the most common causes of low vision due to uveitis.~     The treatment for reducing the intra-ocular inflammation can decrease the macular edema. In~     some patients, CME persists even after inflammation control, and additional treatment is~     needed for better vision. Oral steroid, periocular and intravitreal Triamcinolone are the~     principles in treatment, but some complications like cataracts and increased ocular pressure~     have been seen. Diclophenac is a non-steroid anti-inflammatory drug that improves the vision~     and decreases the macular thickness by slowing down the prostaglandin E2 (PGE2) ending in~     vascular endothelial growth factor (VEGF) inhibition. In this study, the investigators are~     going to compare the therapeutic affect of intravitreal Diclophenac and Triamcinolone in~     persistent uveitic cystoids macular edema. Since diclophenac is a cheap and accessible drug~     in all curative centers it could be applied instead of Triamcinolone.~   "
203826|NCT00893841|"~     This study is designed to assess the use of pramipexole dihydrochloride and quetiapine~     (Seroquel) XR as combination therapy for bipolar depression. The proposed benefit of the~     combination therapy investigated in this study is improved treatment of bipolar depression.~   "
203827|NCT00893828|"~     The PAPIRUS III study will continue to follow patients initially enrolled in PAPIRUS II.~     Pressure readings from the investigational device will continue to be collected and will be~     correlated to physiological changes during activities of daily living and protocol defined~     tests.~   "
203828|NCT00893815|"~     Despite the advent of highly active antiretroviral therapy (HAART), the prevalence of~     neurocognitive impairment among HIV-infected patients continues to be an important issue.~     Although severe forms of AIDS-related dementia have diminished, milder forms of cognitive~     impairment have been noted among approximately 30% of asymptomatic HIV patients. Studies~     among HIV-infected U.S. military personnel regarding neurocognitive function have largely~     been limited to the early 1990s, before the advent of HAART. In these studies subtle~     neurobehavioral changes were noted among asymptomatic HIV-positive military personnel.~      This study proposes to determine the prevalence of neurocognitive deficits among HIV-positive~     military beneficiaries during the era of HAART who are participants of the U.S. Military HIV~     Natural History Study. The prevalence ascertained in this study will be compared to~     HIV-negative military beneficiaries who are demographically similar to the HIV positive~     group. The sample size of the study is to have complete testing on 200 HIV positive and 50~     HIV-negative participants; due to the possibility of attrition before study completion, the~     investigators will enroll up to 300 participants (240 HIV-positive and 60 HIV-negative) to~     achieve this sample size. The investigators' rates among HIV-positive patients found in this~     study will also be contextualized in the setting of the prevalence of prior neurocognitive~     deficits seen in a HIV positive U.S. military population studied in the 1990s, contemporary~     rates among civilian HIV-infected persons, and normative values in the general HIV-negative~     population. Compared to other data in the field of neuropsychology, this study is novel in~     that the HIV population studied is composed largely of HIV patients who have been diagnosed~     early in their HIV infection; have open, free access to antiretrovirals to begin therapy~     earlier than most other cohorts; and consists of highly-functioning, educated individuals.~   "
203829|NCT00893802|"~     The aim of this study is to evaluate the effects of treatment of periodontal disease during~     the second trimester of gestation in adverse pregnancy outcomes.~      Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health~     Center will be divided into two groups: NIG- 'no intervention' or IG- 'intervention,'~     according to agreement in receive periodontal treatment during pregnancy. Treatment will be~     performed by a single periodontist consisting of scaling and root planning (SRP),~     professional prophylaxis (PROPH) and oral hygiene instruction (OHI). Patients at NIG will~     receive PROPH and OHI during pregnancy and will be referred for treatment after delivery.~     Periodontal evaluation will be performed by a single trained examiner, blinded to periodontal~     treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index~     (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days~     post-partum. Primary adverse pregnancy outcomes to be addressed are: preterm birth (< 37~     weeks), low birth weight (< 2.500 Kg), late abortion (14-24 weeks) or abortion (< 14 weeks).~     The results obtained will be statistically evaluated according to OR, unpaired t test and~     paired t test.~      It is expected that periodontal treatment during the second trimester of gestation will~     result in decreased rates of adverse pregnancy outcomes.~   "
203830|NCT00893789|"~     The primary objective of the study is to determine whether armodafinil treatment is more~     effective than placebo treatment in patients with excessive sleepiness associated with mild~     or moderate closed traumatic brain injury (TBI).~   "
203875|NCT00893191|"~     Sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe~     obstructive sleep apnea. The aim of the present study is to examine the frequency of~     sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil~     for sexual dysfunction. In addition we wish to assess the effect of sildenafil on~     sleep-disordered breathing.~   "
203831|NCT00893776|"~     A small, pilot study consisting of twelve participants with subacute (6-12 months~     post-stroke)and chronic stroke (1year+ post-stroke)living in and around Columbia area. The~     twelve participants will randomly be selected to participate in either unilateral~     (one-handed) task training (6 participants) or bilateral (two-handed) task training (6~     participants) with the SaeboFlex orthosis. Each group will undergo six assessments to~     establish pre-testing baseline and qualification, followed by a training session, four-week~     combined home and clinic program, and post-testing to determine changes in affected arm use~     and function. The hypothesis is that two-handed training will before effective than~     one-handed training.~   "
203832|NCT00893763|"~     Ventilator-associated pneumonia (VAP) is a serious complication in mechanically ventilated~     critically ill patients. The intervention tested in this project (swabbing the mouth with~     chlorhexidine before the endotracheal tube is inserted) could reduce the risk of~     ventilator-associated pneumonia.~   "
203833|NCT00893750|"~     More than 300,000 children are fighting in armed conflicts all over the world. In Uganda an~     estimated number of 25,000 children have been abducted and forced to fight or work as porters~     and sex slaves on the side of the rebels during the conflict between the Lord's Resistance~     Army (LRA) and the Ugandan government. Each year, thousands of former child soldiers have~     returned to their communities after they had fled or were freed from the rebels. It is well~     known that a high percentage of these youths are suffering from mental health problems. This~     could be one of the possible reasons why they are facing difficulties to reintegrate into~     their communities.~      The main aim of the proposed project is two-fold. On the one hand, the investigators want to~     systematically explore the relationship between mental health and important variables for~     reintegration into the communities like aggression, hostility, feelings of revenge,~     compromises and conflict behaviour and readiness for reconciliation in formerly abducted and~     other vulnerable youth (orphans, child mothers and handicapped youths) in Northern Uganda. On~     the other hand, the investigators want to probe the efficacy of existing and newly developed~     interventions for formerly abducted and other vulnerable youths that are supposed to foster~     their mental well-being as well as their reintegration into the society and therewith are~     part of the long-term prevention of new conflicts in Northern Uganda.~   "
203834|NCT00893737|"~     Many clinical trials may not fully explore criteria that are important to some migraine~     patients' definition of complete response. This study offers the opportunity to evaluate~     the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck~     pain, irritability or fatigue). Subjects enrolled at 8 investigative sites will complete 2~     visits. Subjects will complete a Completeness of Response Survey at Visit 1 considering their~     usual migraine medication (a triptan) and a Completeness of Response Survey at Visit 2~     considering their study medication (Treximet™).~   "
203835|NCT00893724|"~     Nutritional supplements have an augmentative effect on the outcomes of standard treatment of~     diabetic macular edema (DME) and Neovascular Age-Related Macular Degeneration (NAMD).~   "
203836|NCT00893711|"~     The purpose of this study is:~        -  to study the intestinal microflora of colicky infants before and after L. reuteri or~          placebo administration, evaluating the effect of Lactobacillus reuteri on the growth of~          the main intestinal microbiota (coliforms, Clostridium butyricum, Lactobacilli,~          Bifidobacteria) with fluorescent in situ hybridization (FISH) technique or with~          Real-Time PCR Taqman; Further, the global intestinal microflora composition, using~          large-scale DNA sequencing of 16S rRNA genes ( 454-pyrosequencing technique.~        -  to evaluate the improvement of colicky symptoms by the oral administration of~          Lactobacillus reuteri (primary outcome: reduction of the daily average crying time from~          baseline to the end of the treatment period, to less than 3 hours a day, the cut-off~          proposed by Wessel; secondary outcome: number of responders versus non-responders in~          each group at the end of the treatment).~        -  to evaluate fecal calprotectin values at the beginning and at the end of the study.~          BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland). A~          quantitative immunoassay.~        -  to evaluate Th17/Treg balance at time 0 and t 30 ( days) investigating mRNA FOXP3 and~          RORγ in peripheral blood using RT-PCR Real Time Taqman.~        -  Parental satisfaction at the end of the study period ( 30 day ) with a numerc scale from~          1 to 10.~   "
203837|NCT00893698|"~     The aim of the study is to realize a bilateral transplantation of upper limbs. The first~     objective is functional but there are aesthetic and psychologic imperatives too. This open~     and descriptive study needs compatible donor and recipient. The sample should be realized~     simultaneously and the transplantation should be made by two coordinated teams according to~     this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures.~     An immunosuppressant treatment should be initialized from the beginning of the intervention~     and continued for life. Rejections should be screened by regular clinical and histological~     examinations.~   "
203838|NCT00893685|"~     The DREAMING clinical trial is part of the DREAMING project, which has the objective to~     demonstrate that the DREAMING platform consisting of integrated health monitoring, alarm~     handling and videoconferencing services produces clinical benefits to its users and economic~     benefits to the health authorities. The study evaluates the long-term (30 months) effect of~     continuous use of the DREAMING subsystems and is testing the hypothesis that such use is~     superior to usual care alone in reducing the deterioration of health related quality of life~     that is associated to age and chronic disease. It also tests the hypothesis that the DREAMING~     environment is superior to usual care in delaying the transfer to nursing or elderly homes~     and in reducing the incidence and duration of hospitalisation episodes. The trial will also~     evaluate the cost-effectiveness of the DREAMING platform. Outcomes are assessed in six~     different health care systems (Denmark, Estonia, Germany, Italy, Spain and Sweden) and will~     represent a basis for the adoption of DREAMING services by the respective health authorities.~   "
203839|NCT00893672|"~     Current guidelines recommend Routine daily chest radiographs (CXRs) for mechanically~     ventilated patients in intensive care units (ICUs). However, some ICUs have shifted to an~     On-demand strategy, in which this CXR is only prescribed if warranted by the patient's status~     at the morning physical examination. Here the investigators compared Routine and On-demand~     strategies in 21 French ICUs. The working hypothesis was that CXR prescriptions would fall by~     at least 20% with the On-demand strategy, with no reduction in quality of care.~   "
203840|NCT00893659|"~     The aim of this study is to determine the effect of the potential prebiotic beta-glucan on~     the intestinal microflora, the bacterial enzyme activity (beta-glucuronidase and~     beta-glucosidase) in the feces, the fecal pH and the concentration of fecal short-chain fatty~     acid in polypectomized patients. Also the in vitro anti-cyto- and anti-genotoxicity of fecal~     water will be examined on human cell culture (HT29). During the trial, patient's clinical~     symptoms (intestinal habits), physical activity, well-being and food intake will be recorded.~   "
203841|NCT00893646|"~     The study is a year-long health-behaviour intervention in obese, male truck-drivers to lose~     weight moderately by 10%, using monthly individual counseling. The investigators hypothesize~     that lifestyle modification (increased physical activity, changes in eating habits, and~     improved schedule for sleep) through weight loss improves daytime alertness and quality of~     sleep, reduces daytime sleepiness, and improves cardiovascular risk factors and~     health-related fitness.~   "
203842|NCT00893633|"~     The aim of this research is to investigate critical illness neuromuscular abnormalities in~     neurocritical care patients.~   "
203843|NCT00893620|"~     The Zenith(R) Connection Endovascular Covered Stent Clinical Study is a clinical~     investigation to study the safety and performance of the Zenith(R) Connection Endovascular~     Covered Stent in conjunction with the Zenith(R) Branch Endovascular Graft-Iliac Bifurcation~     in the treatment of aorto-iliac and iliac aneurysms.~   "
203844|NCT00893607|"~     Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when~     administered as a slow release suppository applied to the anal canal or rectum. In addition,~     the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or~     blood pressure were to be assessed.~   "
203845|NCT00893594|"~     This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn~     in the treatment of migraine with aura.~   "
203846|NCT00893581|"~     Specific Aim 1: To determine the effects of treatment with quetiapine or lithium on brain~     activation in adolescents. The investigators will use functional magnetic resonance imaging~     (fMRI) to examine brain activation during an attentional task.~      Specific Aim 2: To determine the effects of treatment with quetiapine or lithium on~     neurometabolite measures, early in their illness course. The investigators will use 1H-MRS to~     identify myo-inositol (mI), N-acetyl aspartate (NAA), and glutamate (Glu) levels in~     prefrontal ALN regions.~      Specific Aim 3: To determine the relationships among the changes in brain activation and~     neurometabolite measures, as well as symptomatic improvement in manic adolescents.~   "
203847|NCT00893568|"~     The post traumatic stress disorder PTSD arises when the physiological response to stress does~     not come to its term. This study aims to explore the cognitive, psycho physiological and~     cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before~     and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his~     service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte~     Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same~     services. The tasks they will be asked to perform will study the psycho physiological,~     cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy~     controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In~     terms of perspectives, this study would help isolate neural systems functionally involved in~     PTSD and its treatment. A better knowledge of those mechanisms would set room for the~     optimization of the current PTSD treatment.~   "
203848|NCT00893555|"~     The objective of this study proposal is to determine whether pharmacologic optimization of~     voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient~     outcomes (efficacy and safety) and is more cost-effective compared to the current standard of~     care.~   "
203849|NCT00893542|"~     The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg~     Capsules under fasted conditions.~   "
203850|NCT00893529|"~     Obesity results from an imbalance between energy intake and energy expenditure. There is much~     speculation about foods that are particularly fattening, and sugary drinks are seen as major~     culprits. It is hypothesized that a high intake of calories from sugary drinks would not be~     compensated for by reduced food intake at subsequent meals. As a result, body weight would~     increase. In this double-blind, long term, randomized controlled trial the effect of~     replacing sugar-containing beverages by low-sugar alternatives on body weight and fat mass in~     children will be investigated.~   "
203851|NCT00893516|"~     Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of~     non cutaneous Tcell lymphoma.~   "
203852|NCT00893503|"~     Colorectal cancer is a major public health concern in Alberta. Colorectal Cancer is the~     fourth most common diagnosed cancer and second overall in terms of cancer deaths in Canada.~     One in 14 males and 1 in 16 females aged 50-74 will be diagnosed with colorectal cancer and~     will have an overall 1 in 28 chance of dying from colorectal cancer. While colorectal cancer~     is surgically curable if diagnosed in the early stages, with five year survival rates of 90%~     versus 10% if detected at more advanced stages, less than 20 % of all individuals in this age~     bracket traditionally have undergone colorectal cancer screening. Colorectal cancer often~     presents with non-specific symptoms where non-cancerous polyps are commonly found. If these~     polyps are left in place, they may grow over time and progress from a non-cancerous mass to~     symptomatic cancerous tumors; therefore, early screening in those patients without symptoms~     may thereby prevent the progression from a non-cancerous to cancerous finding.~      The hypothesis, or theory being studied in the SCOPE Pilot research study, is that~     implementation of a colorectal screening program would decrease colorectal cancer prevalence,~     increase the long-term survival ratio for patients, and decrease burden on the health care~     system. Moreover, early detection and treatment of colorectal cancer has the potential to~     increase the lifespan of patients and decrease health care costs.~      The SCOPE Pilot Research study will recruit 1000 individuals between the ages of 50 - 74 of~     average to high risk for developing colorectal cancer as determined by their referring~     Gastroenterologists. Those patients who are ages 40-50 will also be eligible if they have a~     personal or family history of colorectal cancer. Patients referred to the SCOPE Pilot program~     will be further screened for eligibility, and if no exclusion criterion is present, will be~     invited to attend an education session and research program. The SCOPE Pilot research study~     will compare the current fecal occult blood testing (FOBT - Hemoccult II) with newly~     available FOBT blood testing along with colonoscopy therapy. It will also encompass~     educational information, risk stratification, screening for both average and high risk~     patients, and colonoscopy.~   "
203853|NCT00893490|"~     This randomized, controlled trial (RCT) compares the efficacy and safety of Ahmed Glaucoma~     Valve (AGV) implantation alone, with 3 minutes MMC application or with a single layer~     coverage of amniotic membrane. Outcomes include intraocular eye pressure (IOP), postoperative~     glaucoma medication and complications. AGV implantation site will be superior or inferior~     based on indication and these groups will be randomized separately.~   "
203962|NCT00891982|"~     The purpose of this study is to evaluate the tolerability of a combined regimen of a topical~     antibiotic and retinoid and a benzoyl peroxide wash.~   "
203854|NCT00893477|"~     RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different~     ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or carry cancer-killing substances to them.~     Giving GM-CSF together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works~     in treating patients with previously untreated follicular non-Hodgkin lymphoma.~   "
203855|NCT00893464|"~     This study is an open-label, multicenter, phase 1, dose-escalation study of IXAZOMIB in adult~     patients with lymphoma. This study will be the first to administer IXAZOMIB to patients with~     lymphoma.~   "
203856|NCT00893451|"~     The purpose of this study is to evaluate the impact of vitamin D3 supplementation on the~     insulin resistance in non-diabetic patients with chronic kidney disease (CKD) stages 3-4,~     vitamin D deficiency/insufficiency and elevated fasting serum insulin levels.~   "
203857|NCT00893438|"~     The aim of this study is to determine the efficacy of FITNET (web-based cognitive behavioural~     treatment) for adolescents with Chronic Fatigue Syndrome (CFS) in The Netherlands. The second~     goal of the study is to establish predictors of outcome. It is very important to know the~     characteristics of patients who will benefit from Cognitive Behavioural Treatment (CBT) and~     who will not. Possible predictors of outcome are: age, depression, anxiety, fatigue of the~     mother, parental bonding, self-efficacy, body consciousness of child and mother, physical~     activity (Actometer).~   "
203858|NCT00893425|"~     In recent years, diabetic nephropathy, which may lead to dialysis treatment, is the most~     prevalent underlying disease of people in developed countries. A wide range of studies have~     been carried out, from various points of view, to understand the progress of renal~     dysfunction in diabetic nephropathy. The endogenous nitric oxide synthase (NOS) inhibitor~     asymmetric dimethylarginine (ADMA) is elevated in patients with chronic kidney disease (CKD)~     and may have a role in the cardiovascular mortality and morbidity of these patients. In~     diabetic nephropathy, high ADMA levels were related to progression of diabetic nephropathy.~     The Fas (CD95) antigen is a cell surface polypeptide belonging to the tumor necrosis factor~     receptor (TNF-R) family (type I membrane protein) that transduces a death signal after~     interaction with its ligand. Apoptotic cells are then recognized and removed by phagocytes.~     Recent studies suggest that, in uremic patients, peripheral blood mononuclear cells undergo~     accelerated apoptosis and this correlates with Fas levels. There is no data about the effects~     of Renin angiotensin system blockage (RAS) on CD95 and ADMA levels in diabetic patients with~     proteinuria. The aim of this study was to find out whether the beneficial effects of RAS~     blockage in diabetic proteinuria has any relation with the alteration of ADMA and CD95levels.~     The investigators searched for the effects of ACE inhibitor ramipril on the clinical and~     laboratory parameters of diabetic patients with proteinuria.~   "
203859|NCT00893412|"~     This study evaluates the analgetic effects of the fast-release orodispersible tramadol~     tablet.~      Tramadol acts through a weak affinity for μ receptors and secondly by inhibiting~     noradrenaline and serotonin neuronal reuptake. It has been used since the 1970s by over 50~     million people for the treatment of acute and chronic pain. The orodispersible Tramadol~     tablet is a new galenic form and is available on the Belgian market for the last three years.~     Pregastric absorption leads to a quicker onset of action.~      So far, evidence shows that pain during and immediately after the Hysterosalpingography (HSG)~     procedure is only significantly reduced by IV opioid analgesia. This study evaluates the~     analgetic potential of an orodispersible opioid tablet. This tablet disintegrates rapidly (in~     around 20-30 seconds) and may be taken without water. Its abuse potential is very low and its~     respiratory depressant effect is negligible.~   "
203860|NCT00893399|"~     Randomized Phase-III, two-arm, open-label, multi-center study in adult patients with AML and~     NPM1 mutation.~      Before Amendment No. 4 (December 2013):~      Primary Efficacy Objective:~        -  Evaluation of efficacy based on event-free survival (EFS) after induction and~          consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without~          gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and~          mutant nucleophosmin-1 (NPM1)~      After Amendment No. 4 (December 2013):~      Primary Efficacy Objective:~        -  Evaluation of efficacy based on overall survival (OS) after induction and consolidation~          chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin~          (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1~          (NPM1)~   "
203861|NCT00893386|"~     The purpose of this study is to characterize the removability of the Attain StarFix® Model~     4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead~     removal success in patients that are indicated for left ventricular lead removal. This study~     is required by the Food and Drug Administration (FDA) as a condition of approval for the~     Attain StarFix® Model 4195 LV Lead.~   "
203862|NCT00893373|"~     Sorafenib is a multikinase inhibitor which is acting on various cellular pathways involved in~     the genesis of acute myeloid leukemia (AML). Sorafenib is therefore a promising candidate for~     improvement of chemotherapy results in AML. This clinical trial evaluates the efficacy of~     sorafenib added to standard chemotherapy for AML in patients between 18 and 60 years of age.~     Patients are randomised to receive either sorafenib capsules or placebo in addition to their~     chemotherapy. The placebo and the sorafenib group will be compared regarding event-free~     survival and other clinical outcomes. An event is either treatment failure or relapse or~     death. According to the study hypothesis, the sorafenib group will have less events than the~     placebo group.~   "
203876|NCT00893178|"~     Pulmonary Hypertension (PH) is a disease that is characterized by vasoconstriction of small~     vessels of the lung. Many cases do have proliferation of endothelial cells within these~     vessels. A possible influence of polymorphisms of genes relevant for inflammatory and~     endothelial processes is suspected.~      Especially patients with chronic heart failure can develope PH. The reasons therefore are~     lacking.~      The researchers investigate different polymorphism and the influence of these on pulmonary~     artery pressure (measured invasively) in patients with congestive heart failure (CHF) and~     patients with primary pulmonary hypertension.~   "
203877|NCT00893165|"~     The purpose of this study is to observe a potential benefit of moderate physical activity by~     using bed mounted cycles during hemodialysis treatment sessions on inflammatory markers in~     the blood of patients with end-stage renal disease (ESRD).~   "
203863|NCT00893360|"~     The purpose of this study is to determine whether giving cardiosphere-derived stem cells~     (CDCs) to patients with decreased heart function and/or a large amount of damaged muscle~     after a heart attack is safe. CDCs are cells grown from small biopsy samples taken from the~     heart. Giving a patient their own CDCs is an investigational procedure that has been approved~     by the Food and Drug Administration for this study. In addition to determining whether this~     treatment is safe, the study will also examine whether it can decrease the amount of heart~     muscle damage and/or improve heart function after a heart attack. The amount of heart muscle~     damage and the function of the heart directly affects prognosis (the predicted course of the~     disease), and the development of heart failure and other complications some patients~     experience after a heart attack.~      By way of background, scientists and physicians believed, until just a few years ago, that~     heart muscle damaged after a heart attack could not be replaced. Recently, however,~     scientists discovered that new heart muscle can form, or be regenerated, and that this~     process can be enhanced (or increased) by the administration of large numbers of certain~     cells isolated from the heart or bone marrow. These cells can be stem cells, or cells derived~     from stem cells, and they may achieve their benefit by forming new heart muscle cells,~     becoming heart muscle cells themselves, or releasing substances which increase the ability of~     already existing stem cells to form new heart muscle. All of the studies conducted so far~     have been experimental and no cell type is approved for routine clinical care of patients~     with heart disease. However, studies involving bone marrow stem cells do indicate some small~     improvement in heart function and one large study demonstrated a decrease in clinical events~     in the group which received bone marrow cells.~      Investigators of this study decided to study CDCs because they come from a person's own body,~     and therefore have no foreign immune antigens which may be rejected. Since the cells come~     from the person's heart, they are more likely to form heart tissue. In addition, animal~     studies indicate no safety problems and that these cells are capable of forming heart muscle~     and blood vessel cells after heart attacks. The investigators are now studying whether the~     same is true in humans.~   "
203864|NCT00893347|"~     This study investigates how well a new therapy program prevents persistent symptoms (e.g.,~     headaches, fatigue, irritability, etc.) after concussion. The program involves examining~     beliefs about concussion and learning healthy coping strategies, and is completed with the~     first three months post-injury.~   "
203865|NCT00893334|"~     The purpose of this study is to understand the biochemistry of different types of Limb-Girdle~     Muscular Dystrophy (LGMD) and to determine appropriate outcome measures for future clinical~     treatment trials for LGMD. It is being conducted at two sites in the Cooperative~     International Neuromuscular Research Group (CINRG). It involves a one day clinical evaluation~     at a participating institution that will take approximately four to six hours, and will~     involve strength testing and muscle functional testing by a physical therapist, an evaluation~     by a physician, pulmonary function testing, a complete cardiac evaluation with~     electrocardiogram (ECG or EKG) and echocardiogram (Echo), and involve two blood draws, one~     before the evaluation and one after the evaluation is complete. During the visit, the~     participant will be asked to fill out a couple of questionnaires asking questions about~     quality of life and activity limitations, as well as his/her understanding of their diagnosis~     with regards to etiology (or cause of their muscle disorder), genetics, and inheritance of~     their muscle disorder.~   "
203866|NCT00893321|"~     The purpose of this study is to compare muscle recession and myectomy on inferior oblique~     muscle overactivity.~   "
203867|NCT00893308|"~     Patients' metabolic properties may affect their immune response. This study aims to assess~     the effect of hosts' metabolic properties to viral infection.~   "
203868|NCT00893295|"~     RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to~     treat. Finding out what affects a patient's decision to undergo screening tests may help~     increase the number of patients who undergo regular screening for cancer. It is not yet known~     whether personalized invitations to undergo colorectal cancer screening are more effective~     than standard screening reminders.~      PURPOSE: This randomized phase III trial is studying ways to increase colorectal cancer~     screening in African Americans.~   "
203869|NCT00893282|"~     The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is~     intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.~     It is a water soluble polymer with reverse thermosensitive properties; the polymer exists as~     a liquid at low temperature (below 17 C) and rapidly transitions to a high viscosity gel at~     body temperature (i.e. in the ureter). BackStop is injected above the stones in the ureter~     and is intended to prevent retrograde migration of stones during ureteroscopic lithotripsy.~     Upon completion of the lithotripsy procedure, BackStop dissolves naturally or by irrigation.~      The study hypothesis is that a greater proportion of patients will experience no retropulsion~     of a kidney stone when BackStop is used versus no anti-retropulsion device when undergoing~     intracorporeal lithotripsy.~   "
203870|NCT00893269|"~     Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this~     has not been carefully studied. This research is being done to learn more about sleep~     function in heavy marijuana users, and to determine whether a medication approved for~     treating insomnia can help restore normal sleep function during brief periods of abstinence.~   "
203871|NCT00893256|"~     Negative symptoms in schizophrenia present a challenge to the clinician owing to their poorer~     response to conventional treatment with antipsychotics. Negative symptoms in schizophrenia~     may be secondary to psychotic symptoms, depressive symptoms, drug-related side effects or~     lack of environmental stimulation. Alternately, they may represent core features of the~     illness, characterized as primary deficit symptoms. Previous studies have suggested that~     atypical antipsychotics may be beneficial in improving deficit symptoms of schizophrenia.~     This study aimed at characterizing the nature of improvement of negative symptoms in the~     early phase (12 weeks) of treatment with the atypical antipsychotic, risperidone. In order to~     account for factors contributing to improvement in secondary negative symptoms, ratings were~     carried out of change in positive symptoms, depressive symptoms and drug-related side~     effects. Further, add-on citalopram or placebo were administered in a double-blind design to~     study the effect of selective serotonin reuptake inhibitor (SSRI) augmentation of risperidone~     on negative symptoms. The investigators hypothesized that the improvement in negative~     symptoms during the initial phase (12 weeks) of treatment with risperidone will be largely~     accounted for by improvement in secondary negative symptoms, rather than of the primary~     deficit symptoms.~   "
203872|NCT00893243|"~     Primary Purpose:~        -  To compare the efficacy in treating dry eye syndrome in contact lens wearers or computer~          users of Tears Again® versus Opticol® versus Optive®~      Secondary Purpose:~        -  Subjective evaluation of symptomatology~        -  Evaluation of preference in different kind of administration - spray versus monodoses~          versus multi-doses~   "
203873|NCT00893230|"~     The aim of this study was to assess the clinical effect of Lactobacillus sakei~     supplementation in children with atopic dermatitis.~   "
203874|NCT00893217|"~     The purpose of this study is to valuate safety and tolerability of Betaseron.~   "
206442|NCT00859131|"~     The purpose of this study is to evaluate the safety and efficacy of induction therapy with~     Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).~   "
203878|NCT00893152|"~     Post-traumatic stress disorder (PTSD), prevalent among returning OEF/OIF/OND Veterans, has a~     powerful impact on family functioning. Good family relationships appear to moderate its~     impact; stressful relationships may reduce the benefits of treatment. A program that assists~     both Veteran and family in coping with the Veteran's PTSD could directly improve the~     Veteran's re-adjustment and well-being and indirectly improve his/her social and occupational~     functioning.~   "
203879|NCT00893139|"~     The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective~     for treatment of signs and symptoms of dry eye.~   "
203880|NCT00893126|"~     The purpose of this study is to compare the prevalence and severity of CAD (coronary artery~     disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular~     risk factors.~   "
203881|NCT00893113|"~     The purpose of this study is to assess the effect of Alfuzosin in treating Erectile~     Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline~     in erectile function (EF) domain of International Index of Erectile Function (IIEF).~   "
203882|NCT00893100|"~     The purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in~     reducing pain after hemorrhoidectomy.~   "
203883|NCT00893087|"~     The purpose of this study is to study whether neurally adjusted ventilatory assist (NAVA)~     provides advantages over current methods in detecting patients own breathing efforts in~     pediatric and neonatal ventilatory care.~      Our study hypothesis is that NAVA-technology is more accurate than currently used methods in~     detecting and assisting spontaneous breathing in children, and thus the patient-ventilator~     synchrony will improve.~   "
203884|NCT00893074|"~     A subset of heavy marijuana users have trouble quitting marijuana use and the number of those~     seeking treatment for problems related to marijuana is increasing. The purpose of this~     research study is to investigate whether dronabinol can reduce withdrawal effects associated~     with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked~     marijuana, and whether there are any cognitive performance deficits associated with~     dronabinol doses that produce such effects.~   "
203885|NCT00893061|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Aromatase inhibitors, such~     as letrozole, anastrozole, and exemestane, may fight breast cancer by lowering the amount of~     estrogen the body makes. Hormone therapy, using tamoxifen citrate, may fight breast cancer by~     blocking the use of estrogen by the tumor cells. It is not yet known whether aromatase~     inhibitors or tamoxifen citrate have less effect on memory in patients receiving treatment~     for breast cancer.~      PURPOSE: This randomized phase III trial is studying letrozole, anastrozole, or exemestane to~     see how they effect memory compared with tamoxifen citrate in treating postmenopausal women~     with breast cancer.~   "
203886|NCT00893048|"~     The prevalence of cellulitis in society is very high, as much as 3% of visits to Emergency~     Departments are for the treatment of this disease. The treatment of cellulitis varies~     depending on the severity. Low severity cases are treated with pain control and antibiotics~     by mouth and high severity are treated with antibiotics intravenously and pain control. The~     investigator's hypothesis is to see if the addition of steroids, which are known to decrease~     inflammation, will decrease the length of the disease process. If so, it will decrease the~     length of stay if IV antibiotics are needed, it will decrease duration of days out of work~     and decrease the overall pain control required and therefore patient satisfaction.~   "
203887|NCT00893035|"~     The primary objective of this study is to evaluate the prediction of late toxicity by the~     radiation induced CD8 T-lymphocyte apoptosis~   "
203888|NCT00893009|"~     Chronic obstructive pulmonary disease (COPD) is a chronic progressive respiratory disorder~     causing disability with an increasing burden to the patient, his family and to the health~     services. Treatment of COPD patients depends on the stage of the disease. COPD responds~     poorly to corticosteroids, in spite of inflammation is a major component in its pathogenesis.~     A major barrier to therapy of COPD is resistance to the anti-inflammatory effects of~     corticosteroids. The molecular mechanisms for this corticosteroid resistance are now being~     elucidated, particularly as the molecular basis for the anti-inflammatory effects of~     corticosteroids is better understood (12). An important mechanism of corticosteroid~     resistance in COPD, which is also linked to amplification of the inflammatory process, is a~     reduction in the critical nuclear enzyme histone deacetylase (HDAC)2 . Since the major~     changes are at the level of small airways. We will examine the effect of addition of~     theophylline product to stable COPD patients treated with combined inhaler of inhaled~     corticosteroids.~   "
203889|NCT00892996|"~     Post-operative nausea and vomiting are the major complications after spinal anesthesia with~     intrathecal morphine, therefore antiemetic drugs should be administered for best satisfaction~     of anesthesia to prevent these complication.~      Furthermore, administration of a combination of antiemetic drugs with different mechanisms of~     action appears reasonable and synergistic effect of drugs.~      In conclusion, we study efficacy of antiemetic effect of single antiemetic drug compare with~     combination antiemetic drugs.~   "
203890|NCT00892983|"~     Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the~     first year of life tends to lead to overweight in children, which in turn leads to overweight~     in adults. This rapid early weight gain occurs most often at weaning when eating patterns~     emerge. Infant sleep problems also appear to be associated with the risk of becoming~     overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm~     randomised controlled trial to determine whether extra education and support for families~     around weaning and development of early food and activity habits, with or without~     intervention to improve infant sleep, will decrease the current risk patterns of rapid~     excessive early childhood weight gain in New Zealand. This would provide strong evidence for~     the value of such a strategy in the long term control of the obesity epidemic and its~     consequent complications.~      This is a two-year intervention with 3-year follow-up.~   "
203891|NCT00892970|"~     The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic~     solution, 1% versus placebo over a two-week treatment period.~   "
203892|NCT00892957|"~     The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS)~     versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft~     placement.~   "
207032|NCT00851383|"~     The purpose of this study is to evaluate the safety and immunogenicity of Ad35-GRIN/ENV HIV~     vaccine and Ad35-GRIN HIV vaccine administered intramuscularly at 0 and 6 months.~   "
203897|NCT00892892|"~     The primary purpose is to assess the role of sympathetic activation for the development and~     progression of chronic renal failure. Using microneurography sympathetic activity will be~     registered in various stages of kidney affection or failure and hypertension.~      A sympatholytic agent will be compared with a non-sympatholytic drug to asses the effect~     sympathetic activation and on the progression of kidney disease.~      The effects of a sympatholytic agent on cardiovascular reactivity to various stressors wil be~     examined.~   "
203898|NCT00892879|"~     This is a single-institution, prospective, one-to-one randomized controlled research study.~     Subjects medically determined to need a cholecystectomy will be consented for surgery and~     study participation prior to enrolment in this study. Patients will then be randomized to~     receive either a single port laparoscopic cholecystectomy or a four port laparoscopic~     cholecystectomy.~   "
203899|NCT00892866|"~     This research trial studies carbonic anhydrase 9 (CA-IX), p16, proliferative markers, and~     human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical~     cells. Studying biomarkers in abnormal cervical cells may improve the ability to find~     cervical lesions and plan effective treatment.~   "
203900|NCT00892853|"~     The purpose of this study is to determine if there is a link between calcium build up in the~     veins or arteries (including the veins/arteries of the heart) and deterioration of the bone.~     This will help understand if there is a connection between heart disease and bone disease.~   "
203901|NCT00892840|"~     The purpose of this study is to determine the safety and tolerability of BMS-820836 after~     multiple doses~   "
203902|NCT00892827|"~     Chronic lymphocytic leukemia (CLL), an indolent disease of mature-looking B lymphocytes, is~     the most common leukemia in Israel and the Western world. The disease is associated with~     considerable morbidity and mortality, and is currently incurable. Rituximab (Mabthera) is a~     chimeric monoclonal antibody directed against CD20 antigen, present exclusively on B~     lymphocytes. Treatment with Rituximab is widely used in indolent B cell malignancies.~     However, the administration of Rituximab in CLL patients yields less successful results than~     in other indolent B cell malignancies, and even responding patients may become refractory. We~     hypothesized that the abnormalities in the complement system identified in CLL underlie the~     suboptimal response to Rituximab, since complement-dependent cell cytotoxicity is a major~     mechanism of Rituximab action. Following patient consent and Institutional Review Board~     approval, standard-dose Rituximab (375 mg/m2) will be administered, preceded by 2 units of~     FFP. This treatment will be repeated every 1-2 weeks for 4-6 cycles. The clinical and~     laboratory parameters, as well as adverse drug events, will be monitored.~   "
203903|NCT00892814|"~     The purpose of this trial is to investigate the difference in late radiation morbidity~     between partial breast irradiation and whole breast irradiation given to women operated on~     with breast conservation surgery for early breast cancer with a low risk of local recurrence.~   "
203904|NCT00892801|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving everolimus together with whole-brain radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus and~     to see how well it works when given together with whole-brain radiation therapy in treating~     patients with brain metastasis from non-small cell lung cancer.~   "
203905|NCT00892788|"~     This study will examine a contingency management (CM) intervention designed to provide~     incentives for losing weight versus participating in a manual-guided behavioral weight loss~     intervention alone. Participants in the CM condition will earn the opportunity to win prizes~     by losing weight and completing activities that contribute to weight loss, such as keeping~     daily food and physical activity diaries, choosing healthy foods, exercising, and using other~     weight loss strategies. The investigators will determine if the CM improves weight loss~     relative to the usual care manual-guided intervention alone.~   "
203906|NCT00892775|"~     This study is undertaken to generate clinical data on GSK Biologicals' combined~     measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from~     newly established working seed viruses which are one passage further than the current working~     seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current~     working seed viruses will serve as comparator.~      A seed lot system is a system according to which successive batches of a vaccine are derived~     from the same master seed virus. For routine production, a working seed lot is prepared from~     the master seed virus.~   "
203907|NCT00892762|"~     The purpose of this study is to understand differences in visual function-related~     patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved~     medication (XALATAN®) in patients with open-angle glaucoma or ocular hypertension.~   "
203908|NCT00892749|"~     This is a multi-center, open-labeled, non-comparative study to examine the safety and~     efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia~     patients on hemodialysis.~   "
203909|NCT00892736|"~     This phase I trial studies the side effects and best dose of veliparib in treating patients~     with malignant solid tumors that do not respond to previous therapy. Veliparib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
203910|NCT00892723|"~     The purpose of this study was to determine the safety of AZX100 Drug Product and to determine~     whether it was effective in preventing or reducing re-growth of surgically removed keloid~     scars.~   "
203911|NCT00892710|"~     The purpose of this trial is to evaluate three treatment regimens in patients with stage~     IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not~     previously treated.~   "
203912|NCT00892697|"~     The purpose of this study is to determine the decline of virus in the blood and liver in~     patients treated with telaprevir, pegylated interferon and ribavirin.~      Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance~     the understanding of how the virus decays in the liver in response to treatment with~     anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA~     is an alternative procedure to core needle biopsy in its ability to repeatedly sample the~     liver with significantly reduced morbidity.~   "
204674|NCT00882596|"~     The purpose of this national, multi-site study is to determine the safety and effectiveness~     of the Contura catheter in breast cancer patients undergoing accelerated partial breast~     irradiation.~   "
203913|NCT00892684|"~     The incidence of allergic diseases has increased and a relation between allergy and dietary~     fatty acids has been proposed. Modulation of the maternal immune function during pregnancy~     may have an impact on future clinical outcomes in the child. The aim of this study was to~     determine the effects of omega (ω) - 3 long-chain polyunsaturated fatty acid (LCPUFA)~     supplementation during pregnancy and lactation on the development of allergic disease (i.e.,~     allergic eczema) in the child at 2 years of age. Pregnant women with allergic disease in~     their immediate family were supplemented daily with 2.7 g ω-3 LCPUFA (n=70) or 2.8 g~     soybean-oil as placebo (n=75) from gestational week (gw) 25 until the third month of~     breastfeeding. Skin prick tests, detection of circulating specific IgE antibodies and~     clinical examinations of the infants were performed at 3, 6, 12 and 24 months of age. The~     mothers and children were monitored regarding immune modulatory effects during the entire~     study period.~   "
203914|NCT00892671|"~     This project involves a pre- and post- airway management and vascular access simulation~     survey. The purpose of the study is to assess the perceived effectiveness of the simulation~     course on the performance of medical students enrolling in the Anesthesiology rotation during~     their third and fourth year of medical education.~   "
203915|NCT00892658|"~     Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. The incidence is~     highest in Asia and it is increasing in North America, with a two to three fold increase in~     mortality in North America expected over the next two decades. Previous research has shown~     that tumours often have abnormal blood vessels that may reduce the effect of radiation~     therapy. New drugs, known as anti-angiogenic drugs have been shown in animal and human~     studies to damage or change tumour blood vessels in ways that may make tumors more sensitive~     to radiation treatment. 38-44 patients diagnosed with HCC will be invited to take part in~     this study. Upon completion, this study will establish the safety of the combination of~     radiation and sorafenib in patients with HCC. This will also establish preliminary data~     regarding efficacy of the combination and investigate potential imaging and serum/tissue~     markers surrogates for tumor response and/or drug activity.~   "
203916|NCT00892632|"~     The investigators hypothesize that the confocal endomicroscopy imaging of the biliary~     strictures during ERCP will differentiate between benign and malignant strictures in vivo and~     has increased sensitivity compared to biliary brushing/biopsy, and that direct~     cholangioscopic guidance of pCLE is more accurate than fluoroscopic guidance.~   "
203917|NCT00892619|"~     Epiretinal membranes (ERM) are cellular membranes on the surface of the retina that result in~     distortion of the vision (metamorphopsia), and decreased best-corrected visual acuity. They~     are most frequently found in patients over the age of 50 and have a reported prevalence of~     7-12%. [1,2] Epiretinal membranes are caused by posterior vitreous separation, retinal~     detachment, proliferative vitreoretinopathy, cataract surgery, trauma, inflammation, retinal~     vascular disease, and idiopathic. [1-4] Epiretinal membrane removal by pars plana vitrectomy~     combined with internal limiting membrane peeling leads to improved vision, decreased~     metamorphopsia, and improved quality of life after surgery. [2] Internal limiting membrane~     (ILM) peel has been associated with decreased rates of epiretinal membrane recurrence and is~     also performed during vitrectomy for repair of macular holes or vitreomacular traction. [5,6]~     Internal limiting membrane peeling can be performed by using an instrument to make a break in~     the membrane followed by peeling with forceps, or by utilizing ILM forceps alone to pinch and~     peel an unviolated ILM. No study exists comparing different intraoperative techniques used~     for ILM peeling on visual outcomes and operating time. The investigators hypothesize that~     using a pinch and peel technique will equal outcomes with shorter operating time than other~     techniques.~        1. McDonald HR, Johnson RN, Ai E, Jumper JM, Fu AD. Macular epiretinal membranes. Retina,~          4th edition, editor Ryan SJ, Wilkinson CP, 2006, p 2509-2525.~        2. Ghazi-Nouri SM, Tranos PG, Rubin GS, Adams ZC, Charteris DG. Vitrectomy and epiretinal~          membrane peel surgery visual function and quality of life following. 2006;90;559-562;~          Br. J. Ophthalmol~        3. Haritoglu C, Gandorfer A, Gass CA, Schaumberger M, Ulbig MW, Kampik A. The Effect of~          Indocyanine-Green on Functional Outcome of Macular Pucker Surgery. AM. J. Ophthal. VOL.~          135,NO.3, 328-337, Mar 2003~        4. Hiscott PS, Grierson I, McLeod D. Retinal pigment epithelial cells in epiretinal~          membranes: an immunohistochemical study. Br. J. Ophthalmol, 1984, 68, 708-715~        5. Park DW, Dugel PU, Garda J, Sipperley JO, Thach A, Sneed SR, Blaisdell J. Macular Pucker~          Removal with and without Internal Limiting Membrane Peeling: Pilot Study. Ophthalmology~          Volume 110, 1, Jan 2003~        6. Kwok AK, Lai TY, Yuen KS. Epiretinal membrane surgery with or without internal limiting~          membrane peeling. Clinical and Experimental Ophthalmology, 2005, 33:379-385~   "
203918|NCT00892606|"~     The investigators propose to compare analgesia by methadone and ketamine with a combination~     of morphine and ketamine in orthopedic surgery patients with moderate to severe pain. The~     investigators hypothesize that when given with ketamine before surgical incision, methadone~     is more effective than morphine in reducing postoperative morphine consumption and reducing~     pain during movement.~   "
203919|NCT00892593|"~     The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to~     a colonoscopy screening program will improve colon cancer detection rates.~   "
203920|NCT00892580|"~     The subjects that meet the inclusion and exclusion criteria and consent to participate in~     protocol 22003 will be offered participation in 22003A which will evaluate secreted protein~     before and after treatment with STX209 and placebo to determine if they correlate with~     effectiveness of treatment or susceptibility to treatment with STX209. These same subjects~     will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection.~     The investigators will study the DNA to determine if STX209 works better in people with~     specific gene variations, or to find new gene variations that predict how well STX209 works.~   "
203921|NCT00892567|"~     The purpose of this study is to evaluate T cell responses against a peptide-based vaccine in~     patients with breast cancer and to determine whether peptide-specific T cells can be found at~     the site of breast tumors following vaccination.~   "
203922|NCT00892554|"~     The purpose of this study is to determine if taking supplemental DHA improves measures of~     processing speed and executive function in teen and adult women with PKU.~   "
203923|NCT00892541|"~     The purpose of this study is to evaluate the effects of an organic cation transporter~     inhibitor, trimethoprim, on the pharmacokinetics of orally administered ER OROS paliperidone~     and to assess the safety and tolerability of the treatments in healthy male volunteers.~   "
203924|NCT00892515|"~     RATIONALE: Exercise may change the risk of developing breast cancer. It is not yet known~     whether low-intensity exercise or high-intensity exercise is more effective in lowering the~     risk of breast cancer.~      PURPOSE: This randomized clinical trial is studying how well exercise programs work in~     healthy young women at increased risk of developing breast cancer.~   "
203925|NCT00892502|"~     The purpose of this study is to determine whether treatment with Bismuth can reduce the~     toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.~   "
207066|NCT00850915|"~     Isoniazid preventive therapy (IPT) is a well studied clinical intervention for primary and~     secondary prevention of active tuberculosis (TB) after infection with Mycobacterium~     tuberculosis. It is widely used in industrialized countries in TB outbreak management,~     focusing on high risk groups such as close contacts in the family, in congregate settings,~     and in the workplace amongst others. Individuals infected with Human Immunodeficiency Virus~     (HIV) have a markedly higher risk of acquiring a TB-infection and developing consequently~     active TB, making HIV-infected individuals a target population for IPT. Studies of IPT in HIV~     infected persons in the nineties demonstrated the efficacy of IPT in the prevention of active~     TB in Sub -Saharan Africa and more recent studies suggest that the protective effect remains~     present in individuals on antiretroviral therapy.~      Despite the proven efficacy of IPT this intervention has not been taken up by most HIV and TB~     control programmes in Africa where the burden of TB/HIV is highest. The reasons for the low~     uptake of IPT are many and varied but include fears of expansion of isoniazid resistance and~     subsequently the development of multi -drug resistant TB with widespread use of IPT.~     Additionally screening protocols for excluding active TB and selecting persons for IPT have~     not been uniformly agreed upon. There have also been concerns that programmes designed to~     provide IPT may shift TB control programmes from their primary responsibility of finding and~     treating active TB. Finally it has been unclear as to which programme, between the HIV and~     the TB control programme, has the primary responsibility of managing the provision of the IPT~     intervention.~      The World Health Organization and other technical agencies engaged in global TB control have~     recently re-emphasized the need to scale up IPT. In this proposal we outline an operational~     research study to evaluate the introduction of IPT at community level and to measure its~     effectiveness at preventing TB. The study is based on the context of expansion of~     Community-Based Direct Observed Therapy Short Course (CB-DOTS), home-based care and the~     concept of HIV prevention with positives (PwPs), where there is a real opportunity to focus~     on the household as a source of HIV-associated tuberculosis.~      The study is designed as a cluster randomized trial. It compares the incidence of TB in~     household contacts including children under 5 of identified TB/HIV co-infected patients, who~     received IPT through proactive community intervention and those in a control group where the~     community was handled in the usual way. In the intervention group household contacts of~     index cases of HIV positive, smear positive PTB will be visited at home and consenting~     contacts will be screened for active TB using a simple questionnaire. Those found to be fit~     will receive isoniazid 300mg (5 mg per Kg for children) once daily for 6 months, regardless~     of the HIV-status. Those found not to be fit will be referred for further evaluation at the~     nearest TB diagnostic centre. In the control group, routine care following national~     guidelines will be offered. This consists of contact invitation and assessment of eligibility~     for IPT, especially, in children less than 5 years. Both groups will be followed up monthly~     through household visits. Follow up will be for a total of 24 months including the six months~     when IPT is provided.~      A confidential HIV screening test will be provided to all consenting contacts in both~     intervention and control group after appropriate counseling.~      The primary outcome is the incidence of TB in the intervention and control household~     contacts. The difference in incidence between the two groups is a measure of efficacy of the~     intervention. In addition the efficacy of the intervention will be estimated stratified by~     HIV status of household contacts if data allows. Secondary outcomes are the incidence of~     adverse events, the incidence of TB-related symptoms, measures on the uptake of IPT~     (proportion of contacts starting and discontinuing IPT, treatment adherence) and programmatic~     indicators, i.e. percentage of persons eligible for IPT and resources needed.~   "
203927|NCT00892476|"~     The purpose of this study is to determine if supplementation of calcium by the enteral route~     (gut feeding) to extremely low birth weight infants will lead to less myopia~     (nearsightedness) at 6-12 months postnatal age.~      Secondly, the study will determine if calcium supplementation is well tolerated, if it~     reduces the molding of these premature infants' heads, and if it decreases myopia at the~     18-22 month postnatal age visit.~   "
203928|NCT00892463|"~     The proposed study is for a 6 week open-label clinical trial in which Seroquel XR is added to~     a selective serotonin reuptake inhibitor (SSRI) medication for the treatment of depressive~     and/or anxiety symptoms. Each subject will self-report changes in symptoms, functional~     impairment, etc. on a twice daily basis using a handheld computer (HHC) that transmits~     real-time symptoms reports to a central database. Each subject will be assessed in-person on~     a weekly or biweekly basis during the course of the study.~   "
203929|NCT00892450|"~     The purpose of this research study is to investigate the cognitive (thinking, memory,~     knowledge, intelligence) side effects of two medications commonly used to treat overactive~     bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the~     Philadelphia PADRECC.~   "
203930|NCT00892437|"~     The objective of this study is to evaluate the safety and efficacy of a regimen containing~     cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate~     (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1~     infected, antiretroviral treatment-naive adults.~      Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA~     level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants~     will continue to take their blinded study drug and attend visits every 12 weeks until~     treatment assignments are unblinded, at which point all participants will return for an~     unblinding visit and be given the option to participate in an open-label rollover extension~     and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until~     Gilead Sciences elects to terminate the study.~   "
203931|NCT00892424|"~     Cancers that have spread to the liver from the primary cancer location (liver metastases)~     that cannot be removed surgically (unresectable) can be treated with chemotherapy and/or~     radiation therapy. Previous research has shown that tumours often have abnormal blood vessels~     that may reduce the effect of radiation therapy. New drugs, known as anti-angiogenic drugs~     have been shown in animal and human studies to damage or change tumour blood vessels in ways~     that may make tumors more sensitive to radiation treatment. 32- 44 Patients diagnosed with~     unresectable liver metastasis will be invited to take part in this study. The purpose of this~     study is to investigate the use of a new anti-angiogenic drug called Sorafenib, in~     combination radiation therapy and chemotherapy. The study will test how effective the new~     treatment is, the side effects associated with the new treatment, and to help establish safe~     dosages of the study medication.~   "
203932|NCT00892411|"~     Background. Patients with chronic low back pain display hyperexcitability of the central~     nervous system (central hypersensitivity). Such hypersensitivity may occur in the acute phase~     and represent a risk factor for the development of chronic pain.~      Objective. To determine the prognostic value of central hypersensitivity for the development~     of chronic low back pain.~      Design. Prospective cohort study.~      Setting. Primary care.~      Patients. 140 individuals with acute low back pain and no history of chronic pain.~      Outcomes. Primary prognostic variable will be the pain tolerance threshold at the second toe~     (the pressure intensity at which a further increase in pressure is deemed intolerable).~     Exploratory secondary prognostic variables are measures of mechanisms related to central~     hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat and cold~     stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation); localized vs.~     widespread hypersensitivity; spinal cord modulation (electrophysiological measures of~     hypersensitivity and changes in receptive fields); modulation at brain level (descending~     modulation of nociceptive input and cortical plasticity). Clinical primary outcome will be~     the occurrence of chronic low back pain at follow-up.~      Main analysis. The investigators will use least square logistic regression models to~     determine the association of central hypersensitivity with prognosis.~      Relevance. An understanding of the prognostic value of central hypersensitivity may allow an~     early stratification for treatment of individuals at risk of developing chronic low back~     pain. Subgroups of patients may be selected for clinical trials on novel pharmacological~     approaches for the prevention and treatment of central hypersensitivity.~   "
203933|NCT00892398|"~     Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery~     involves creating a door in the eye wall in order to improve fluid outflow and decrease~     intraocular pressure. However, success rates range from 70% to 90% depending on the criteria~     used and tend to decrease with time. The failure of the surgery is associated with~     inflammation, new blood vessel formation and scarring which can cause closure of the door.~     Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial~     growth factor have been used successfully to decrease scarring in animal eyes where little~     doors were created and significantly improve survival. Furthermore, they have shown promise~     when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also~     been used safely in intraocular surgery to treat other diseases which involve new blood~     vessel formation such as macular degeneration and diabetes.~      The investigators hypothesize that ranibizumab may decrease the failure rate of~     trabeculectomy with mitomycin C by decreasing scarring.~      The aim of the study is to evaluate the difference in failure rates and bleb morphology at~     one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab~     in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone~     trabeculectomy with mitomycin C alone.~   "
203934|NCT00892385|"~     RATIONALE: Drugs used in chemotherapy, such as methoxyamine and temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving methoxyamine together with temozolomide may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of methoxyamine when~     given together with temozolomide in treating patients with advanced solid tumors.~   "
203963|NCT00891969|"~     RATIONALE: A study that looks at communication between patients and doctors may help~     oncologists improve patient satisfaction with their treatment plan.~      PURPOSE: This phase I trial is studying treatment decision making between oncologists and~     women with newly diagnosed breast cancer and their healthy companions.~   "
203935|NCT00892372|"~     Control of body weight (BW) is important to prevent and manage type 2 diabetes. Regardless of~     the close association, little is understood about the precise relationship between BW and~     glycemic control, which might be of benefit for patients with type 2 diabetes. The~     researchers investigated the correlation between changes in BW and glycemic control in~     patients with type 2 diabetes treated with a diet therapy or pioglitazone.~   "
203936|NCT00892359|"~     The purpose of this trial is to study the pharmacokinetics of anidulafungin during continuous~     venovenous hemofiltration.~      Background: Anidulafungin is a cyclic lipopeptide antifungal agent of the echinocandin class.~     Members of this class of antifungal agents are known to inhibit the synthesis of glucan~     polymers in fungal cell walls. The spectrum of activity of anidulafungin includes Candida~     (all species, including strains resistant to fluconazole), Aspergillus, and Pneumocystis.~      In intensive care patients continuous venovenous haemodiafiltration (CVVHF) is a~     well-established extracorporal renal replacement therapy with a high clearance rate.~      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHF~     are rare. No data about anidulafungin in CVVHF are available although intensive care patients~     are perfect candidates for anidulafungin treatment due to their high risk profile for~     systemic fungal infections.~      Study objective: The study is conducted to investigate the pharmacokinetics of anidulafungin~     during CVVHF in critically ill patients.~      Study design: open, 1 arm~      Study population: 10 critically ill adult patients administered to the ICU with acute renal~     failure and suspected or proven fungal infection.~      Treatment/Dosage/Route: On the first day 200 mg of anidulafungin will be administered~     intravenously over 3 hours (loading dose). The following days 100 mg of anidulafungin will be~     administered intravenously over 1.5 hours.~      Main outcome variables: The following pharmacokinetic parameters will be determined: area~     under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination~     fraction.~      Methods: High pressure liquid chromatography (HPLC) will be used to determine anidulafungin~     concentrations.~   "
203937|NCT00892346|"~     The clinical trial is to evaluate the efficacy of single autologous hematopoietic stem cell~     transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide~     maintenance in patients with newly-diagnosed myeloma after receiving 4-6 cycles of induction~     chemotherapy consisting of vincristin,adriamycin and dexamethasone (VAD) or~     thalidomide/dexamethasone between 18 to 65 years.~   "
203938|NCT00892333|"~     The rate of hernia recurrence at one year following repair of a large abdominal hernia with a~     biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of~     40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year~     following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being~     that such rate will be less than 20% at one year, representing a 50% reduction over the~     historic rate of 40%.~   "
203939|NCT00892320|"~     The purposes of this study are to evaluate the effect of food on the pharmacokinetics of~     extended-release (ER) OROS paliperidone in healthy Japanese adults and to assess the safety~     and tolerability.~   "
203940|NCT00892307|"~     Researchers hope that this new non-invasive multi-detector scanner (DSCT) will provide~     diagnostic information comparable to the combination of traditional SPECT (for function and~     blood flow) and CT imaging (for a precise anatomical view).~   "
203941|NCT00892281|"~     The objective of this study is to assess the effectiveness, safety, subject satisfaction and~     quality of life with Oracea® when used as monotherapy or as add-on therapy to existing~     topical regimens for the treatment of rosacea.~   "
203942|NCT00892268|"~     RATIONALE: Acupuncture may reduce joint pain in postmenopausal women with breast cancer. It~     is not yet known whether acupuncture is more effective than standard therapy analgesics in~     decreasing joint pain caused by aromatase inhibitors.~      PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works~     compared with medication in reducing pain in postmenopausal women with breast cancer and~     joint pain.~   "
203943|NCT00892255|"~     The purpose of this protocol is to pathologically evaluate the destruction by microwave~     ablation of primary and metastatic liver tumors. The primary aim is to measure tissue~     destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System.~   "
203944|NCT00892242|"~     The overall purpose of this research is to evaluate the safety and side effects of zoledronic~     acid (also known as Zometa) in patients before they have surgery to remove the cancer.~   "
203945|NCT00892229|"~     The purpose of this study is to determine the effectiveness of buccal misoprostol and~     comparing this with vaginal route of the same drug.~   "
203946|NCT00892216|"~     Post-operative nausea and vomiting (PONV) is not only unpleasant for patients but also can~     delay hospital discharge and increase cost of stay. In some cases, when severe vomiting~     occurs, pain scores seem to be increased. The overall incidence of PONV is 30% and increases~     to 79% in patients at high risk for this post-operative outcome. The NUSS procedure is~     considered to be a procedure with a high risk for the outcome of nausea and vomiting.~   "
203947|NCT00892203|"~     This study will assess the efficacy and safety of BGG492 used to treat migraine pain.~   "
203948|NCT00892190|"~     This is an open label, prospective, single institution dose-escalation study. The patient~     population includes non-induction candidate elderly patients with AML or MDS and/or patients~     with high-risk or relapsed/refractory AML or MDS. Five dose cohorts will be evaluated using a~     fixed dose of ATRA in combination with an escalating dose of dasatinib. The investigators~     will treat with an escalating dose of dasatinib from 70mg to 140mg daily. Dose escalation~     will proceed in a standard 3+3 fashion. A de-escalation to a 50 mg total daily dose of~     dasatinib is planned if DLT is greater than or equal to 33% is observed at the first dose~     level. Once the MTD for the combination of the drugs has been established, up to 6 additional~     patients will be enrolled at the MTD level to obtain additional safety information about the~     combination and to allow for preliminary laboratory correlate analysis.~   "
203991|NCT00891605|"~     Safety study of ABT-263 in Combination with Paclitaxel in Subjects with Solid Tumors.~   "
204007|NCT00891384|"~     This trial is a randomised, parallel-group, multicenter phase III study for maintenance~     therapy with lenalidomide in patients with multiple myeloma who were treated with high-dose~     therapy and autologous stem cell transplantation as first line therapy.~   "
213765|NCT00761852|"~     Ruboxistaurin is being tested to see if it is effective in treating certain diabetic~     complications, such as diseases of the blood vessels.~   "
203949|NCT00892177|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also~     block the growth of the tumor by blocking blood flow to the tumor. It is not yet known~     whether bevacizumab together with dasatinib are more effective than a placebo in treating~     patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.~      PURPOSE: This randomized phase I/II trial (Phase I completed) is studying the side effects~     and best dose of dasatinib when given together with bevacizumab and to see how well it works~     compared to placebo in treating patients with recurrent or progressive high-grade glioma or~     glioblastoma multiforme.~   "
203950|NCT00892164|"~     The objective of this study is to compare the results of total thyroidectomy using the new~     harmonic scalpel device to that with the electrothermal bipolar vessel sealer.~   "
203951|NCT00892151|"~     The purpose of this study is to evaluate a Diabetes management program in the hands of~     potential users, both health care professionals and lay persons.~   "
203952|NCT00892138|"~     This study will assess the short and long term effects of a group-based mindfulness programme~     (Mindfulness-Based Stress Reduction, MBSR) on first year medical and psychology students at~     the Universities of Oslo and Tromso.~      The primary outcome variables are mental distress, student stress and subsequent work stress,~     subjective wellbeing, empathy, mindfulness and spirituality. The investigators will also~     study explanatory moderator and mediator variables.~      The study will be a two-centre randomized controlled study involving 288 medical and~     psychology students from the University of Oslo and from the University of Tromso. The sample~     size calculation is based on a reduction in mental distress and perceived medical/psychology~     school stress of 20% in the intervention group. The control group will not receive an~     intervention. After the initial seven week course (taking place in 2009 and 2010) the~     intervention group will receive a follow-up session of 1.5 hours twice a year throughout~     their study course of 5-6 years. The follow-up period will last until 1 year after graduation~     in the Oslo cohort and until 3 years after graduation in the Tromso cohort.~   "
203953|NCT00892125|"~     The purposes of this study are to evaluate the effects of a potent metabolic enzyme inducer,~     carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER~     and to evaluate the safety and tolerability of the treatments in clinically stable patients~     with a diagnosis of schizophrenia or bipolar I disorder.~   "
203954|NCT00892112|"~     A prospective randomized double-blind placebo-controlled trail to investigate the effect of~     high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of~     patients with chronic symptomatic ICM and a high PVB19 load in the heart.~   "
203955|NCT00892099|"~     Infection is the second-leading cause of death in individuals requiring dialysis treatment~     for kidney failure. New research suggests the high risk of infection may be due in part to~     low levels of vitamin D, which are extremely common in kidney disease. This study is designed~     to determine safe and effective ways to raise vitamin D levels while monitoring effects on~     the immune system.~   "
203956|NCT00892086|"~     The purpose of this study is to collect the prevalence of geriatric syndrome, which is~     recognized by an internist, and to compare the data based on the comprehensive geriatric~     assessment by a geriatrician. The secondary outcome is to develop a practical collected form~     for the internist.~   "
203957|NCT00892073|"~     To study the effect of combined diazoxide-metformin therapy on body weight in youth with~     hypothalamic obesity following treatment for craniopharyngioma. A secondary objective is to~     evaluate changes in insulin resistance (IR), beta-cell function, features of the metabolic~     syndrome, muscle metabolism and intramyocellular lipid.~      Hypothesis: Treatment with diazoxide and metformin will result in weight loss or slowed~     weight gain and improved metabolic profile, compared to pretreatment levels.~   "
203958|NCT00892047|"~     The primary aims of this study are to:~        1. Assess the efficacy of aripiprazole augmentation for the acute and continuation~          treatment of TRLLD.~           Hypothesis 1: Patients with TRLLD (defined as those who do not remit after 12 weeks of~          acute treatment with venlafaxine XR) will have a higher rate of remission with~          aripiprazole than with placebo augmentation (primary outcome) and greater improvement in~          depressive symptoms and stability of remission (secondary outcomes).~        2. Assess the tolerability of aripiprazole in TRLLD with a focus on adiposity and~          akathisia/restlessness.~      Hypothesis 2: Aripiprazole will be associated with a higher rate of clinically significant~     akathisia and increased adiposity than placebo.~      The Secondary/exploratory aims of this study are to:~        1. Examine anxiety, medical burden, and executive impairment as moderators of aripiprazole~          augmentation efficacy in TRLLD.~           Hypothesis 3: Pre-levels of anxiety symptoms, medical burden, and executive impairment~          will be treatment-specific factors: they will moderate the efficacy of aripiprazole~          augmentation. The aripiprazole-placebo difference will be greater in individuals with~          these variables, compared to those without these variables because these three factors~          will be associated with a decreased likelihood that staying the course with~          venlafaxine monotherapy will achieve remission.~        2. Examine genetic predictors (phase 1) and moderators (phase 2-3) of treatment outcomes,~          while controlling for drug exposure.~      Hypothesis 4: Selected polymorphisms will reduce remission rate with venlafaxine and will~     reduce efficacy and tolerability with aripiprazole.~   "
203959|NCT00892021|"~     This study will evaluate the safety of multiple doses of NSA-789 in subjects with~     schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is~     absorbed and eliminated, and its effect, if any, on the brain.~   "
203960|NCT00892008|"~     This study is being conducted as a regulatory requirement post initial marketing~     authorization. This is primarily a safety study. This was an open label study and patients~     were enrolled once the decision to prescribe the medication was made by the Investigator.~   "
203961|NCT00891995|"~     The purpose of this study is to find out if very tight blood glucose control from the onset~     of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned~     to receive either standard diabetes management or intensive diabetes management, which~     involves several days of closed loop therapy followed by home use of a continuous glucose~     monitor and insulin pump.~   "
203964|NCT00891956|"~     Background:~        -  Rett syndrome (RS) is a panethnic (affecting all ethnicities) neurodevelopmental~          (impairment of the growth and development of the brain) disorder affecting primarily~          females. RS is characterized by the loss of intellectual functioning, fine and gross~          motor skills, and communicative abilities after a period of seemingly normal~          development.~        -  Caregivers of individuals with RS face many psychosocial challenges. The stressors can~          be grouped into the following six categories: emotional difficulties, health-related~          stressors, uncertainty about their daughter s illness, rejection by their social~          environment, lack of available or competent experts, and unfavorable comparison with~          healthy children.~        -  Researchers are making a significant contribution to the adaptation literature with a~          focus on family functioning and to the little psychosocial research that exists on~          families with RS.~        -  Researchers hope to narrow down the most important areas on which to focus for~          intervention strategies in families with RS.~      Objectives:~        -  To describe family functioning, perceived illness burden, self-efficacy, types of coping~          methods, and adaptation in caregivers of individuals with RS to examine the~          relationships between these variables and the outcomes of family functioning and~          adaptation.~        -  To examine the extent to which appraisals of being a caregiver of an individual with RS~          and methods of coping are associated with family functioning.~        -  To examine the extent to which appraisals of being a caregiver of an individual with RS,~          methods of coping, and family functioning are associated with caregiver adaptation.~      Eligibility:~      - Eligibility is based on answering yes to the following three questions: Are you 18 years~     old or older? Are you the caregiver of a child diagnosed with Rett Syndrome? and Does the~     child with Rett Syndrome currently reside in your home with you?~      Design:~        -  Participants in this cross-sectional research design will answer a quantitative survey~          that includes some open-ended questions. The cross-sectional study involves a one-time~          self-administered questionnaire that takes approximately 20 to 30 minutes to complete.~        -  The survey will be available in paper and electronic versions and includes demographics~          questions, measures of perceived illness burden, parental self-efficacy, coping methods,~          family functioning, and adaptation. Participants also will answer open-ended questions~          related to the individual s diagnosis.~        -  Participants may withdraw from the study at any point up until submission of the survey~          and may skip any question.~        -  Participants who experience psychological distress as a result of taking the survey are~          advised to contact the researcher. Study coordinators at the various clinics from which~          participants will be recruited will be notified of the possibility of adverse events and~          instructed to direct any members who experience distress to the appropriate professional~          services.~        -  Participants will receive a small financial compensation for completing the survey.~   "
203965|NCT00891943|"~     The purpose of this study is to conduct a randomised controlled trial to assess the sustained~     effects on weight, selected risk factors and sense of well-being of offering individualized~     weight management advice in the primary care setting to patients who wish to lose weight; and~     to identify the key factors influencing the success of the intervention.~   "
203966|NCT00891930|"~     This study is designed to evaluate the mechanism(s) of resistance to the anti-epidermal~     growth factor receptor (EGFR) antibody panitumumab given in combination with irinotecan in~     metastatic colorectal carcinoma (mCRC) patients with wild-type Kirsten rat sarcoma-2 virus~     oncogene (KRAS) tumor status at the time of initial diagnosis.~   "
203967|NCT00891917|"~     The purpose of this study is to measure the effects of LiQ-NOL supplementation on language~     production using the Clinical Evaluation of Language Fundamentals test, language sampling~     using the mean length of utterance test, and speech articulation using the Goldman-Fristoe~     Test of Articulation.~   "
203968|NCT00891904|"~     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells.~      PURPOSE: This clinical trial is studying the side effects of radiation therapy given together~     with cetuximab and to see how well it works in treating patients with recurrent head and neck~     cancer.~   "
203969|NCT00891891|"~     The purpose of this longitudinal study is to evaluate a developmentally-oriented~     bio-neuropsychological model of adjustment in youth and young adults with spina bifida. The~     theoretical framework for the study is a developmentally-oriented bio-neuropsychosocial model~     of psychological adjustment.~   "
203970|NCT00891878|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. It is not yet known whether~     capecitabine is more effective when given alone or together with sunitinib malate in treating~     patients with metastatic esophageal cancer or gastroesophageal junction cancer.~      PURPOSE: This randomized phase II trial is studying how well capecitabine works compared with~     capecitabine given together with sunitinib malate as first-line therapy in treating patients~     with metastatic cancer of the esophagus or gastroesophageal junction.~   "
203971|NCT00891865|"~     The purpose of this study is to determine whether respiratory viral infections increase the~     risk of bronchiolitis obliterans syndrome (BOS), obliterative bronchiolitis (OB), death, or~     retransplantation in children who have received lung transplants.~   "
203972|NCT00891852|"~     The overall significance of this study is to develop a laboratory developed test (LDT) to use~     a new marker in the maternal blood to better identify pregnancies that have a child with a~     chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18),~     Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome~     abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and~     CVS procedures.~   "
203973|NCT00891839|"~     The purpose of this study is to determine the efficacy and safety of the combination of~     bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma.~   "
203974|NCT00891826|"~     This study sets out to test the hypothesis that parameters of heart rate variability, as a~     non-invasive measure of cardiovascular risk, can be improved by the addition of omega-3 fatty~     acids in euthymic bipolar patients with a low omega-3 index and reduced heart rate~     variability.~   "
203975|NCT00891813|"~     The purpose of this study is to observe the effectiveness and safety of the use of a low~     initial dose regime (iPTH/100) in chronic kidney disease patients with secondary~     hyperparathyroidism (PTH>300pg/mL) and that require dialysis at least 3 times per week.~   "
203976|NCT00891800|"~     The purpose of this study to study whether or not the use of direct radiation therapy with~     Y-90 microspheres (SIR-Spheres) has any effect on treated liver with respect to tumor~     response in breast cancer patients.~      Criteria:~        -  Breast cancer~        -  Clinical evidence of metastatic disease in the liver~        -  Performance status (0-2)~        -  Not pregnant~        -  Laboratory values received after any prior chemotherapy~        -  Normal Pt/PTT~        -  recovered from any chemotherapy side-effects~        -  No prior radiation therapy to the liver~        -  No other MAJOR site of cancer such as lungs or brain~        -  No uncontrolled infections~        -  a candidate for surgical resection or ablation therapy~   "
204008|NCT00891371|"~     The purpose of this study, is to assess the effect of lanreotide Autogel 120mg on stool~     frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to~     baseline.~   "
203977|NCT00891787|"~     Background:~        -  Probiotics are oral food supplements containing live bacteria that may be beneficial to~          a person s digestion or general health. Probiotics are available as tablets, powder, or~          liquid supplements and are frequently used to supplement yogurt. They are available for~          purchase without prescription in most supermarkets.~        -  The bacteria in probiotic supplements commonly express sugar substances on their~          surface. These sugar substances are similar to group A and B blood group sugars, called~          antigens. These antigens determine a person s blood group. Researchers are studying the~          effect of probiotic supplements on the amount of blood group antibodies that are present~          in a person s blood.~      Objectives:~        -  To determine whether taking oral probiotic supplements increases anti-A and anti-B~          isoagglutinins (antibodies that cause red blood cells to clump together) in healthy~          subjects.~        -  To study the frequency of these effects and determine whether there is a dose-response~          relationship with probiotics and isoagglutinin titers.~      Eligibility:~        -  Healthy adults, 18 years or older, with type A, B, or O blood.~        -  Female participants need to have undergone menopause or have had a hysterectomy.~        -  Individuals are ineligible if they currently donate platelets; have a history of~          ulcerative colitis or Crohn s disease; have had major bowel surgery; are pregnant or~          capable of becoming pregnant; have a bleeding or clotting disorder; have a history of a~          blood disorder or immune deficiency; have a history of high-risk behaviors for exposure~          to HIV or hepatitis B or C; have diabetes; have received vaccinations in the past 2~          months, with the exception of the flu vaccine; are currently taking immunosuppressive~          medications; are currently taking antibiotics; or have taken probiotic supplements~          within the last 12 months.~      Design:~        -  Researchers will conduct the following tests throughout the 28-week study:~             -  Blood samples will be drawn every 2 weeks to measure the quantity of isoagglutinin~               titers.~             -  Depending on individual results, continued blood testing may be done every 3 months~               for 1 year, then every 6 to 12 months for up to 5 years.~        -  Study subjects will take a probiotic supplement at a dose of 1 to 3 caplets per day for~          18 consecutive weeks according to the following schedule:~             -  During the first 6-week period, the subject will take one probiotic tablet daily.~             -  During the second 6-week period, the subject will take one probiotic tablet twice~               daily.~             -  During the third 6-week period, the subject will take one probiotic tablet three~               times daily.~        -  Control group subjects will be followed in a similar manner but will not take probiotic~          supplements.~        -  The outcome measure is the percent of probiotic ingestors (the study subjects) versus~          control group subjects who experience a fourfold or greater rise in isoagglutinin titer.~        -  Study subjects will receive the following financial compensation: $10 per blood sample,~          for a maximum of $240 if all 24 samples are collected; $100 after completing the first~          6-week period; $150 after completing the second 6-week period; and $200 after completing~          the third 6-week period.~        -  Control subjects will receive $10 per blood sample, for a maximum of $150 if all 15~          samples are collected.~   "
203978|NCT00891774|"~     Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to~     deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with~     EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. They will be~     observed for 6 months to establish safety of the product as it relates to scarring and~     changes in skin pigment, and long term effectiveness.~   "
203979|NCT00891761|"~     This is a phase III study designed to demonstrate the superiority of single-dose 90 mg~     intravenous (IV) casopitant over placebo, each in combination with ondansetron and~     dexamethasone, for the prevention of emesis over the first 0-120 hours (overall phase)~     following initiation of the cisplatin infusion in the first cycle of highly emetogenic~     chemotherapy (HEC). Eligibility is limited to subjects who are scheduled to receive their~     first cycle of chemotherapy which includes at least 60 mg/m2 of cisplatin administered on Day~     1 only of a 21 day or 28 day cycle. All subjects will receive IV ondansetron and oral~     dexamethasone on Day 1 prior to initiation of the cisplatin infusion, followed by oral~     dexamethasone on Days 2-4. Additionally, subjects will be randomized to receive single-dose~     90 mg IV casopitant or matching placebo prior to initiation of a cisplatin-based HEC regimen.~   "
203980|NCT00891748|"~     The study objective is to evaluate the feasibility of three instillations of~     immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance,~     toxicity and immunological parameters will be evaluated during and post treatment.~   "
203981|NCT00891735|"~     This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the~     efficacy and safety of ranibizumab injection administered intravitreally to patients with~     choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).~     Results are presented for the first 12 months of the study.~   "
203982|NCT00891722|"~     RATIONALE: Studying samples of tumor tissue and blood in the laboratory may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to cancer. It may~     also help doctors understand why low-grade gliomas develop in young patients and predict how~     they will respond to treatment.~      PURPOSE: This clinical trial is studying tumor tissue, blood samples, and family history in~     predicting tumor development and response to treatment in young patients with low-grade~     glioma.~   "
203983|NCT00891709|"~     The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data~     when LEO 29102 is administered cutaneously as single and multiple doses to healthy male~     subjects.~      The study is divided into one single dose part followed by a multiple dose part.~   "
203984|NCT00891696|"~     Muscle wasting, which involves the loss of muscle tissue, is common in many conditions, such~     as cancer, AIDS, trauma, kidney failure, bone fracture, and sepsis. It is also prevalent~     among the elderly and in people who experience periods of physical inactivity and~     weightlessness. Muscle wasting can lead to overall weakness, immobility, physical dependence,~     and a greater risk of death when exposed to infection, surgery, or trauma. There is a need to~     develop scientifically based treatments that prevent muscle wasting. As one step towards such~     a goal, this study will examine the physiological and cellular mechanisms that regulate~     skeletal muscle growth.~   "
203985|NCT00891683|"~     Two Phase 1 studies have been conducted with AEG33773 and available safety and tolerability~     data from these studies support further clinical development of AEG33773. The current study~     is proposed as a proof-of-concept study to assess the potential analgesic efficacy of~     AEG33773 to reduce pain associated with chronic Diabetic Peripheral Neuropathy.~   "
203986|NCT00891670|"~     The purpose of this study was to determine the impact of adjunctive cilostazol on platelet~     inhibition in carriers and non-carriers of the loss-of-function CYP2C19 allele.~   "
203987|NCT00891657|"~     This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open~     label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique,~     versus good surgical technique alone, with a blinded, third party video evaluation of~     adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.~   "
203988|NCT00891644|"~     This is the second phase of a two-phase, cross-sectional study of linkage to medical care of~     HIV positive youth. Social, psychological and behavioral factors associated with receipt of~     care will be evaluated. This study will also compare three methods for recruitment of~     out-of-care youth using a randomized permuted block list of possible sequences.~   "
203989|NCT00891631|"~     The goal of the project is to develop and test an internet/intranet-based Screening, Brief~     Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad~     range of serious health-risks and problem behaviors.~   "
203990|NCT00891618|"~     The goal of this clinical research study is to learn if giving acupuncture to patients with~     lymphoma or a plasma cell dyscrasia can help to relieve numbness and/or tingling of the feet~     and/or hands that is related to chemotherapy.~   "
203992|NCT00891592|"~     This protocol will enroll subjects with advanced hematologic malignancies who do not have a~     suitable related or unrelated donor to undergo a Stem Cell Transplant.~      In this study, subjects will undergo a Stem Cell Transplant using Cord Blood. Part of the~     cord blood will be used for the Stem Cell Transplant and part of the cord blood will be sent~     to a laboratory in order to grow the T cells (from the cord blood) and increase the activity~     of the cord blood T cells.~      The purpose of this part of the study is to see if it is safe to give study subjects~     activated T cells made from a small portion of their donor UCB unit immediately after the UCB~     transplant. Activated T cells have been used safely in stem cell transplantation studies in~     the past, but they have never been studied UCB transplantation.~   "
203993|NCT00891579|"~     This study is a prospective trial of Alimta (pemetrexed) versus IRESSA (gefitinib) among~     epidermal growth factor receptor wild-type Non-Small Cell Lung Cancer (NSCLC) patients in a~     2nd line setting.~   "
203994|NCT00891566|"~     The purpose of this study is to determine whether the immobilization period is helpful for~     the better healing of repaired rotator cuff.~      The investigators hypothesis is that the longer immobilization after rotator cuff repair will~     help the healing of rotator cuff.~   "
203995|NCT00891553|"~     The purpose of this study is to determine whether bone mineral density has increased in a~     subgroup of postmenopausal osteoporotic women from study CR9108963, between 6 and 12 months~     following cessation of ronacaleret therapy.~   "
203996|NCT00891540|"~     The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 %~     versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.~      The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid~     consumption.~   "
203997|NCT00891527|"~     The objective of this study is to conduct a pilot study using biologic agents Avastin and~     Gleevec to treat progression of multivessel intraluminal pulmonary vein stenosis in children.~   "
203998|NCT00891514|"~     The purpose of this study is to examine the effects of treadmill training on inflammation in~     the skeletal muscle and adipose tissue, insulin action in the skeletal muscle, and whole body~     glucose metabolism in stroke survivors. The fundamental hypothesis of this study is that key~     inflammatory markers in adipose tissue and skeletal muscle are abnormal, skeletal muscle~     insulin signaling is impaired, and systemic insulin sensitivity is reduced in hemiparetic~     stroke patients and that these factors are modifiable and improved by exercise training in~     stroke patients.~   "
203999|NCT00891501|"~     This study is conducted to assess whether implanting autologous, culture-expanded,~     mesenchymal stem cells obtained from the bone marrow of patients with early osteoarthritis,~     cartilage defects or cartilage and underlying bone and cartilage (osteochondral) defects in~     joints is effective in the treatment of such conditions and alleviation of patients symptoms.~   "
204000|NCT00891488|"~     The purpose of this study is to test the hypothesis that physiological adaptations to regular~     exercise training (i.e. physical fitness) attenuates age-related decline in stress resilience~     to both oxidative stress and the neuroendocrine responses to psychosocial stress.~   "
204001|NCT00891475|"~     The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in~     metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical~     treatment. Ablation may allow for reduced morbidity and may increase the likelihood of~     patients receiving systemic therapy.~   "
204002|NCT00891462|"~     The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium~     bromide doses as compared to placebo in the treatment of moderate to severe chronic~     obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period,~     12-week double-blind treatment, and 2-week follow-up phone visit.~   "
204003|NCT00891449|"~     Space flight simulation study to study effects of microgravity through bedrest coupled with~     flight exercise counter-measures.~   "
204004|NCT00891436|"~     Rationale and objectives:~      Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when~     used for the treatment of seasonal allergic rhinitis during the ragweed pollen season.~     Although this is the only published report of an intranasal corticosteroid shown to~     effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the~     tears of patients with allergic conjunctivitis are known to have increased concentrations of~     cytokines and allergic mediators.~      The objective of this study is to determine if the positive effects of Veramyst nasal spray~     on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators~     will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray~     decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst~     nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the~     amount of allergic mediators detected in their tears.~   "
204005|NCT00891423|"~     Meropenem is a powerful antibiotic used in intensive care for people who have very serious~     infections. Meropenem is rapidly removed from the blood by the kidneys and it is very~     expensive. In very ill patients in intensive care, it is uncertain how best to give this~     antibiotic. Studies have suggested that a smaller dose given over a longer period of time,~     results in blood levels of meropenem that are just as good as when a higher dose is given~     over a shorter period of time. This direct comparison has not been tested in intensive care~     patients. It is important to know this because if giving a lesser amount more slowly is just~     as good, then doctors will choose to give meropenem this way. To establish whether this is~     the case, the investigators plan to conduct an initial (pilot) study in ten intensive care~     patients at Austin hospital.~      Adult (age 18 years or older) patients in intensive care who have a serious infection being~     treated with the antibiotic, meropenem for three days or more will be able to participate in~     this study. The decision to start meropenem will be made by the intensive care doctors and~     they will give it in the usual way for 24 hours.~      The investigators will then in a random way (like tossing of a coin), give the participant~     meropenem either in the usual way (1 gram infused over 30 minutes) or give them a smaller~     amount, but over a longer period of time (500 milligrams infused over 3 hours). This will be~     done for 24 hours. They will then receive meropenem in the alternative way for another 24~     hours. After this time the intensive care doctors will decide how meropenem will continue to~     be given.~      Blood levels of meropenem will be measured to see if they are the same when meropenem is~     given in each of the two different ways. During each different way of giving meropenem, 7~     blood samples will need to be taken. Ten mls (or one spoonful) of blood will be required for~     each measurement. Blood levels will be taken through monitoring lines, which will be already~     present.~      Other information will also be collected about the participant during this study. This will~     include their age, gender, height, weight, information about what other medical conditions~     they have and measurements of how well their kidneys are functioning.~   "
204006|NCT00891397|"~     The purpose of this study is to assess the efficacy of pregabalin in patients with complex~     regional pain syndrome Type I and to determine whether it provides clinically significant~     pain relief and whether it improves functioning of the upper limb.~   "
214421|NCT00753090|"~     This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to~     evaluate the clinical efficacy of the DDRP components.~   "
204009|NCT00891358|"~     This study will begin to develop a culturally appropriate secondary prevention intervention~     for young HIV+ women through focus groups.~      Using three intervention sites, focus groups will guide the development of the intervention's~     framework and content areas. An intervention will be developed/adapted through the data~     collected in the focus groups and review of relevant interventions. The intervention aims to~     address the following concerns: 1) reducing the risk of young women infected with HIV~     transmitting the virus to their sexual partners, and 2) preventing young women infected with~     HIV from re-infection with a new viral strain or co-infection with another sexually~     transmitted disease.~   "
204010|NCT00891345|"~     This study is a phase I study of a new cell based prostate cancer therapy (ALECSAT). In this~     therapy specific cells from the patient's own immune system are isolated, activated and~     re-administered to the patient to boost a specific immune response against the cancer cells.~     The aim of the study is to show safety and tolerability for this type of therapy. It is the~     hypothesis that the cells administered during the therapy will attack the tumour cells and in~     this way stop or slow down the progression of disease.~   "
204011|NCT00891332|"~     This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1~     week on and 1 week off) as first -line treatment for patients with metastatic colorectal~     cancer.~   "
204012|NCT00891319|"~     Impaired hand function is one of the most frequently persisting consequences of stroke. The~     purpose of this study is to compare two different treatments -- Contralataterally Controlled~     Functional Electrical Stimulation (CCFES) and Cyclic Neuromuscular Electrical Stimulation~     (cNMES) -- for improved recovery of hand function after stroke.~   "
204013|NCT00891306|"~     This trial is designed to expand the currently available data on the safety and efficacy of~     alipogene tiparvovec treatment in lipoprotein lipase deficiency (LPLD) and to further the~     understanding of possible mechanisms of action of the therapy.~   "
204014|NCT00891293|"~     This was a 24-month, open-label extension study that followed an 8-week double-blind study~     (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study~     LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid~     ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum~     triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone.~     This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza~     (omega-3-acid ethyl esters) [formerly known as Omacor] therapy in hypertriglyceridemic~     subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.~   "
204015|NCT00891280|"~     This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability and highest~     safe dose level of this CK2 inhibitor in patients with advanced solid tumor cancers,~     Castleman's Disease or Multiple Myeloma.~   "
204016|NCT00891267|"~     The purpose of this study is to study the effect of two doses of olmesartan medoxomil and~     amlodipine on vascular markers in hypertensive patients with metabolic syndrome.~   "
204017|NCT00891254|"~     The intraperitoneal repair has been proven safe for the repair of incisional hernia and is~     accepted, together with the subfascial or retromuscular repair as the gold-standard for the~     repair of incisional hernia. However no studies have convincingly proven that this approach~     is better than the on-lay repair.~      The authors believe that the intraperitoneal repair performs better than the on-lay repair~     for incisional hernia.~   "
204018|NCT00891241|"~     The purpose of this clinical study is to estimate the radiation dosimetry of a single dose of~     LMI1195 in healthy subjects and heart failure patients undergoing positron emission~     tomography (PET)~   "
204019|NCT00891228|"~     To determine the number of men who have suppression of sperm production when using a daily~     regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.~   "
204020|NCT00891202|"~     This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate~     (Genz-112638) in participants with Gaucher disease Type 1.~   "
204021|NCT00891189|"~     Asthma is a disease that affects the lungs. Symptoms include repeated episodes of wheezing,~     breathlessness, chest tightness, and nighttime or early morning coughing. Some people with~     asthma experience worse symptoms at night, which is known as nocturnal asthma (NA). The~     reason for the decline in lung function at night in some asthmatics is not well understood,~     but it may be linked to the human biological clock, which controls daily activity and sleep~     rhythms. To determine whether differences in biological clocks relate to worsening nocturnal~     lung function, this study will evaluate the circadian rhythms of people with NA, people with~     non-nocturnal asthma, and healthy people.~   "
204022|NCT00891176|"~     This protocol posting deals with objectives & outcome measures of an extension phase when~     subjects are aged 3, 4 and 6 years of age. The objectives & outcome measures of the primary~     phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives~     & outcome measures of the booster phase are presented in a separate protocol posting (NCT~     number = NCT00463437).~      The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal~     serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are~     aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the~     study.~   "
204023|NCT00891163|"~     The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera~     topical patch (using sensory depth and pain depth evaluations), and to determine the duration~     (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing~     and thermal sensory testing evaluations), compared with a matching heated placebo patch.~   "
204024|NCT00891150|"~     The goal of this study is to determine the best dose of a drug called oxytocin, that is~     usually used to stop bleeding during a delivery, when used during a cesarean delivery. It~     will be administered during cesarean section in order to decrease the amount blood loss. The~     investigators are proposing to have 3 groups of subjects each given a different safe dose of~     oxytocin and then to assess the effectiveness of each regimens on the amount blood lost~     during cesarean sections.This will let use know which is the best lowest dose needed.~   "
204081|NCT00890396|"~     Sickle cell anemia (SCA) is an inherited blood disorder that can cause organ damage. The BABY~     HUG study is evaluating the use of the medication hydroxyurea at preventing organ damage in~     children with SCA. The purpose of this follow-up study is to evaluate the long-term effects~     of hydroxyurea in children who have participated in the BABY HUG study.~   "
204025|NCT00891137|"~     Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to~     accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an~     umbilical cord blood transplant for hematologic cancer. In this study, the safety and~     tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will~     be determined by monitoring for adverse reactions, neutrophil and platelet recovery,~     hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.~   "
204026|NCT00891124|"~     This study will address the proportion of achievement patients in treatment target goal on~     glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline, among~     outpatients coming to the Korean primary care nationwide.~   "
204027|NCT00891111|"~     The purpose of this study is to understand using incentives to encourage employees to~     increase participation in an aspect of a corporate wellness program - filling out health risk~     assessments. This study will test whether lottery-linked incentives are more effective than~     guaranteed incentives in encouraging people to fill out health risk assessments.~      This study will be run in an employer setting in which rates of health risk assessment~     completion are suboptimal. This study would be conducted within a workplace setting in which~     the firm is divided into a number of geographically situated and functionally related~     subunits. The investigators will run a complete your health risk assessment now! program~     for 4 weeks. Each work unit will obtain a symbol. Every week, one symbol will be randomly~     drawn, publicly announced, and anyone in that work unit at the firm who has received their~     preventive screening would receive a $100 prize. In addition, if all of employees in that~     unit have completed their forms, then the prize will be increased to $125.~      The investigators expect this condition to result in greater compliance compared to a control~     condition in which employees would receive weekly reminders and a direct payment of a $25~     gift card for completing the form at anytime during the 4 weeks of the study. This is~     analogous to direct payments that have been used by insurers to encourage completion of such~     forms in other contexts.~   "
204028|NCT00891098|"~     The outcome of trauma treatment (Posttraumatic Stress Disorder - PTSD) may be influenced by~     which emotions that are predominant among current symptoms, e.g. fear, anger, guilt, shame.~     Different treatment procedures for processing traumatic memories may resolve different~     emotions. This study compares two different treatment procedures of working with trauma~     memories in PTSD treatment (namely, Imaginal Exposure and Imagery Rescripting) in order to~     test this.~   "
204029|NCT00891085|"~     The purpose of this study is to collect data on patients who are on breathing machines~     (ventilators) in the Trauma Surgical Intensive Care Unit (TSICU). This data may help us to~     determine if one form of assisted breathing is better than another. The two forms of assisted~     breathing being compared in this study are called BiVent and SIMV. (7) BiVent and SIMV are~     both delivered by a ventilator but differ in how they assist breathing. SIMV is an older form~     of mechanical breathing that blows air into the lungs to inflate the lungs. BiVent is a newer~     form of mechanical ventilation that permits the patient to pull air into the lungs as we~     normally do. Both BiVent and SIMV are currently being used on a regular basis in the TSICU.~     The investigators hope that this study will determine if one method of assisted breathing is~     better than another in preventing complications associated with mechanically assisted~     breathing.~   "
204030|NCT00891072|"~     This phase I trial is studying the side effects and best dose of gossypol when given together~     with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or~     cannot be removed by surgery. Drugs used in chemotherapy, such as gossypol, paclitaxel, and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving gossypol together with paclitaxel and~     carboplatin may kill more tumor cells~   "
204031|NCT00891059|"~     The Diskus Inhaler is administered by a nurse or medical technician in the Nursing Home (NH)~     setting. The administration of the medication from the Diskus Inhaler includes 4 steps: open,~     click, inhale, close. The only step that the resident must do is the inhale step, which~     includes holding one's breath for 10 seconds after the inhalation.~      The investigators propose that properly trained and motivated nurses and medical technicians~     can successfully administer medication using the Advair Diskus to almost any mildly to~     moderately cognitively impaired resident who can follow the instruction- inhale and hold~     your breath for 10 seconds. The objective is to show that mild to moderate cognitive~     impairment should not be a barrier to the use of Diskus Inhaler. There will only be 1 consent~     visit and 1 evaluation visit per subject.~   "
204032|NCT00891046|"~     This open-label extension study will permit patients with Systemic Juvenile Idiopathic~     Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab~     treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg~     s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or~     when study CACZ885G2402 is in place at their study center or around March 2013, whichever~     occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2~     mg/kg s.c. every 4 weeks.~   "
204033|NCT00891033|"~     Multiple myeloma (MM) accounts for approximately 1% of all malignancies and 10% of~     hematological tumors, representing the second most frequently occurring hematological~     malignancy in the United States. At any one time, 50,000 people suffer from MM, and~     approximately 15,000 are diagnosed each year. The median age is approximately 65 years,~     although occasionally MM occurs in the second decade of life.~      Bortezomib and panobinostat intravenous (IV) are active agents in multiple myeloma and appear~     to work through different biochemical pathways, suggesting that there may be a synergistic~     effect using the combination. Both compounds have shown anabolic bone effect, which has been~     associated to significant anti-myeloma activity.~      Primary objectives:~        -  To assess the toxicity of bortezomib combined with one of 4 doses of panobinostat IV in~          patients with relapsed/refractory multiple myeloma, and~        -  To find the most appropriate doses of bortezomib and panobinostat IV in the combination.~      Secondary objective:~        -  To assess the effect of bortezomib in combination with panobinostat IV on inducing~          osteoblast activation in patients with relapsed/refractory myeloma.~   "
204095|NCT00890214|"~     The researchers investigated the influence of a prostacyclin analogue (PGIA) versus~     unfractionated heparin (UFH) on ex vivo platelet function, during continuous venovenous~     hemodiafiltration.~   "
204034|NCT00891020|"~     This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of~     tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had~     inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk~     mitigation strategies developed in partnership with the FDA to manage known and potential~     risks associated with the treatment of tocilizumab. Patients will be randomized to receive~     tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic~     DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of~     6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample~     size is 500-1000 individuals.~   "
204035|NCT00891007|"~     Partially randomized, controlled Phase II study to evaluate safety, immunogenicity and dose~     response of the measles vaccine MVA mBN85B in healthy children aged 6 months to 6 years.~   "
204036|NCT00890994|"~     In this research study, the investigators are testing a new type of breast camera, called~     Molecular Breast Imaging, to see if it can find tumors in the subject's breast.~   "
204037|NCT00890981|"~     To evaluate the combined effect of denosumab treatment and discontinuation on cortical~     thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography~     (HR-pQCT). Participants randomized to either denosumab or placebo in the 20050179~     (NCT00293813) study who completed that study (ie, attended an end of study visit) can be~     included in this study. At least 12 months should have elapsed since the patient's 20050179~     end of study visit.~   "
204038|NCT00890968|"~     The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is~     safe and effective in the treatment of hand dermatitis.~   "
204039|NCT00890955|"~     Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide~     and anthracyclines has been studied and concluded that the combination was tolerable, could~     be given safely, and therapeutically useful.~      This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in~     relapsed solid tumors and will define the MTD of the combination in a US population.~   "
204040|NCT00890942|"~     The purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective~     in prophylaxis of intrathecal morphine induced pruritus after cesarean section.~   "
204041|NCT00890929|"~     This study has a phase 1 and a phase 2 component.~      In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide~     when after azacitidine.~      In phase 2, the objective is to determine the efficacy of the combination treatment.~   "
204042|NCT00890916|"~     The purpose of this study is to evaluate the effectiveness of an implanted stimulator for~     providing hand function to individuals with cervical level spinal cord injury. The device~     stimulates the paralyzed muscles of the hand and forearm. The user of the device controls the~     stimulation by moving muscles that are not paralyzed, such as a wrist or neck muscle. The~     ability of the user to pick up and move objects, as well as perform various activities such~     as eating, drinking, and writing.~   "
204043|NCT00890903|"~     The purpose of this non-interventional study is to collect data on efficacy and toxicity of~     the use of Navelbine ORAL in daily routine in Germany (especially after availability of an~     80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.~   "
204044|NCT00890890|"~     The purpose of this study is to determine the safety and tolerability of BMS-708163 in~     patients with Prodromal Alzheimer's disease over a treatment period of a minimum of~     104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post~     treatment.~   "
204045|NCT00890877|"~     This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of~     three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist~     drugs alone. This study will compare the patients on OC000459 at three different dose levels~     (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after~     dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment~     arm will consist of at least 110 subjects. The objective is to assess the efficacy of these~     dose levels on the patients asthma.~   "
204046|NCT00890864|"~     The purpose of this pilot study is to assess the feasibility and acceptability of randomising~     the phasing-in of the age extension of the NHS Breast Screening Programme in six volunteer~     sites in different areas of England.~   "
204047|NCT00890851|"~     The TUNA is a known and already old technique. There exists, in the literature, a certain~     number of studies showing the long-term effectiveness (5 years), evaluated on the IPS and the~     flow mictional.This effectiveness is slightly lower than that of the endoscopic resection of~     prostate. This technique does not present the disadvantages of the surgery prostate sufferer~     on ejaculation. Moreover, it can be carried out in short hospitalization or ambulatory as it~     is the case in particular in the States Unis. The aim of the study which will be led by the~     AP-HP will be thus to test the feasibility of the TUNA during a hospitalization of less 24~     hours.~   "
204048|NCT00890838|"~     The perioperative administration of n-3 fatty acids has been shown to lead to favorable~     effects on outcome in patients with severe surgical interventions by lowering the magnitude~     of inflammatory response and by modulating the immune response. To the investigators'~     knowledge, no study with preoperative administration of intravenous (IV) omega 3 fatty acids~     as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its~     effects on inflammatory and immune response has been conducted. So, this study has been~     planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty~     acids in elderly patients undergoing valvular surgery considering the hyperinflammation~     associated with this type of surgery in elderly patients.~   "
204049|NCT00890825|"~     The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel~     versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic~     non small cell lung cancer.~   "
204096|NCT00890201|"~     Pancreaticobiliary reflux has been found in patients with cholelithiasis and gallbladder~     cancer associated with normal pancreaticobiliary union. However, the presence of~     pancreaticobiliary reflux has not been studied in patients without gallstones (healthy~     gallbladders).~      The authors believe that pancreaticobiliary reflux might be a normal phenomenon in patients~     with and without gallstones, although in patients with cholelithiasis it might constitute a~     pathological condition associated with dismotility of the biliary tree and the sphincter of~     Oddi.~   "
204050|NCT00890812|"~     The purpose of this study is to evaluate the utility of measuring coagulation factor~     activities in the setting of acute ischemic stroke, as potential markers of inherited~     thrombotic risk. The investigators will determine if relationships exist between coagulation~     factors, including factor VIII, factor IX, and factor XI and clinical diagnosis,~     classification, and outcome. The investigators will determine if any significant elevations~     of these factor activities are independent thrombotic risk factors.~      Null Hypothesis: There is no statistical difference between coagulation factors, including~     factors VIII, IX, or XI activity levels in patients having acute ischemic stroke as compared~     to acute stroke mimics.~   "
204051|NCT00890799|"~     The purpose of this study is to investigate effectiveness and safety of transcatheter closure~     of perimembranous ventricular septal defects.~   "
204052|NCT00890786|"~     The outcome for children with high-grade gliomas and diffuse intrinsic brainstem gliomas~     remains poor despite the use of multi-modal therapy with surgery, radiation therapy and~     chemotherapy.~   "
204053|NCT00890760|"~     Malaria affects around 515 million people each year, about a million of whom die from the~     disease. It is a major problem for those who live in affected areas as well as for travellers~     to affected areas. There is a great need for a safe, effective malaria vaccine. The purpose~     of this study is to test 2 new vaccination regimes that include a new malaria vaccine~     candidate, for their ability to prevent malaria infection.~      The vaccines are different types of virus which contain genetic information (DNA) from the~     malaria parasite. This genetic material is named ME-TRAP. The aim is to use these viruses to~     help the body make an immune response against the malaria parasite. Both viruses are~     inactivated so that they are unable to multiply within the body.~      The first vaccine virus is a weakened version of a common cold virus. Such adenoviruses occur~     in many strain types and commonly infect chimpanzees as well as people and this vaccine uses~     a strain originally derived from a chimpanzee. The vaccine is called AdCh63 ME-TRAP.~      The other virus is Modified Vaccinia Ankara Virus, (MVA), which is a safer form of the~     vaccine virus previously widely used for smallpox vaccination. The vaccine is called MVA~     ME-TRAP.~      This study will enable the investigators to assess:~        1. The ability of different vaccine combinations to prevent malaria infection~        2. The safety of the vaccine combinations in healthy volunteers~        3. The response of the human immune system to the vaccines~   "
204054|NCT00890747|"~     This phase I trial studies the side effects and the best dose of sunitinib malate in treating~     human immunodeficiency virus (HIV)-positive patients with cancer receiving antiretroviral~     therapy. Sunitinib malate may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~   "
204055|NCT00890734|"~     The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma~     symptoms in patients with allergic bronchial asthma. The active treatment will be compared~     against placebo.~   "
204056|NCT00890721|"~     Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and~     their pain and pain medicine use will be monitored.~   "
204057|NCT00890708|"~     The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole~     is useful in the treatment of invasive fungal infection.~   "
204058|NCT00890695|"~     The purpose of this study is to determine whether an outpatient-based strategy of short-term,~     ready to use supplementary food (RUSF) among moderately malnourished children with acute~     infections achieves greater improvement in anthropometric measurements of wasting than usual~     diet.~   "
204059|NCT00890682|"~     After undergoing bunion surgery, patients are given a pain medicine injection that may last~     for up to several days or a placebo. Their pain and pain medicine use is then monitored.~   "
204060|NCT00890669|"~     Parkinson's disease (PD) causes motor and non-motor impairments that affect the quality of~     life of the subjects. The purpose was to assess the effects of treadmill walking training~     with additional body load on the quality of life and motor symptoms of the subjects with PD.~      Methods: Nine subjects with PD, Hoehn and Yahr stages 2 through 3, not demented and with~     capability to ambulate independently voluntarily participate in this study. The training~     program was divided into three phases (A1-B-A2): treadmill training with additional body load~     (A1), control condition (conventional physical therapy group) (B) and treadmill training with~     load again (A2). Each phase lasted six weeks. The quality of life and motor symptoms were~     assessed by PDQ-39 and UPDRS, respectively. Both evaluations and training were performed~     during on-phase of the medication cycle.~   "
204061|NCT00890656|"~     The goal of this clinical research study is to learn if a special combination of chemotherapy~     drugs called augmented hyper-CVAD chemotherapy given over 6 to 8 months followed by monthly~     maintenance chemotherapy for one year can help to control acute lymphoblastic leukemia or~     lymphoblastic lymphoma. The safety of this therapy will also be studied.~   "
204062|NCT00890643|"~     In this study, the investigators are looking at how PTSD affects things such as memory,~     attention, reaction to sounds, eye movements, and heart rate. The investigators are also~     studying whether a medication called prazosin has an effect on these things.~   "
204063|NCT00890630|"~     The purpose of this study is to examine the feasibility of using intracervical balloon~     catheters for cervical ripening as part of labour induction in healthy, GBS-negative women~     with prelabour rupture of membranes at term.~   "
204064|NCT00890617|"~     RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with~     primary stage I non-small cell lung cancer or lung metastasis.~   "
204079|NCT00890422|"~     The study aims to answer this question: whether adequate immunity can be achieved in a short~     time, that is, by a rapid immunisation process, using at least one of 3 new TBE immunisation~     schedules? The investigators will test the immunogenicity (the degree of immunity achieved)~     of each of the immunisation schedules at various times after the injections. If the results~     of this clinical study are positive, it may then be possible to develop the most successful~     immunisation schedule so that it can be used routinely. This means that the results of the~     clinical study have an enormous practical value in preventing TBE in people travelling or~     moving into areas with a high TBE risk.~   "
204080|NCT00890409|"~     The purpose of this study is to investigate the effectiveness and safety of selective head~     cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).~   "
204065|NCT00890604|"~     When fever is present in patients with stroke, traumatic brain injury (TBI), or brain~     hemorrhage, it has been associated with worse outcomes including larger areas of tissue~     death, increased length of stay, worse degree of coma, lower ability to function, and higher~     mortality. Both adult and pediatric TBI national guidelines state that maintenance of normal~     body temperature should be a standard of care. However, no further standards or options are~     presented to specifically guide practice. The current ischemic stroke guidelines state that~     fever should be treated with fever-reducing agents and offer cooling devices as an option~     but do not provide specifics to guide practice. Over 50% of patients in the Neurosurgical~     Intensive Care Unit (ICU) at Harborview Medical Center develop fever during the course of~     their stay. With elevated temperatures the body consumes more oxygen than if the temperature~     was normal, causing less oxygen to be available to the brain. This may lead to injury of the~     brain cells and a diminished capacity for healing. Thus, temperature management in~     neurologically vulnerable patients is both a prevalent and problematic challenge. Based on~     this information the goal of the present proposal is to evaluate if 1) A standardized,~     step-wise approach to temperature management using a Normothermia Protocol is successful in~     achieving and maintaining normal temperature in Neurosurgical ICU patients; and 2) If~     maintenance of normal temperature will be associated with fewer episodes of diminished~     responsiveness in their neurological exams as evidenced by a measure of depth of coma, as~     measured by the Glasgow Coma Score (GCS) compared to a control group treated according to~     usual care.~   "
204066|NCT00890591|"~     In patients naive to treatment or after a 2-week washout period for patients whose treatment~     was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme:~     monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.~   "
204067|NCT00890578|"~     The use of tissue adhesives for the closure of surgical incisions is becoming increasingly~     common. Several publications exist purporting the equivalence of tissue adhesive to suture~     with regard to dehiscence, infection, and cosmesis. Two of the most frequently used adhesives~     are Histoacryl© and Dermabond©. Despite their popularity, only one study exists comparing the~     two. In this non-English study only small wounds in an exclusively pediatric population were~     studied (12). Operative time, cost, and objective measures of scar size were not examined. In~     the present study we aim to evaluate the relatively large surgical incisions resulting from~     breast reduction, mastopexy, panniculectomy, and abdominoplasty closed with either~     Histoacryl©, Dermabond©, or subcuticular suture. The primary aim is to investigate~     differences in time to wound closure. Secondary aims are to compare the three approaches with~     respect to cost, dehiscence, infection, scar size, and cosmesis.~   "
204068|NCT00890565|"~     This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to~     placebo and moxifloxacin in healthy subjects.~   "
204069|NCT00890552|"~     This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone~     (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day~     cycles.~   "
204070|NCT00890539|"~     The purpose of this study is to determine the difference (if any) in the result of the~     methacholine challenge (a test used by physicians in diagnosing asthma) when concentrations~     of methacholine are quadrupled versus doubled.~   "
204071|NCT00890526|"~     Hyperacusis is the intolerance to sound levels that normally are judged acceptably loud to~     others. The presence of hyperacusis (diagnosed or undiagnosed) can be an important reason why~     some persons reject amplified sound from hearing aids. Tinnitus Retraining Therapy (TRT),~     originally proposed for the treatment of persons with debilitating tinnitus, offers the~     significant secondary benefit of increased Loudness Discomfort Levels (LDLs), along with~     expansion of the dynamic range for loudness. TRT uses both counseling and sound therapy from~     daily exposure to soft sound from bilateral noise generator devices (NGs) and has been~     promoted as an intervention for hyperacusis. The hypothesis of this investigational study is~     that the counseling and sound therapy principles used in TRT can be applied successfully to~     treat hearing-impaired hearing-aid candidates with reduced sound tolerance who are otherwise~     should benefit from hearing aids.~   "
204072|NCT00890513|"~     The primary aim of the present study is to assess satisfaction in a large sample of next of~     kin in Swiss-German ICUs.~      Secondary aims are to test the hypothesis that family satisfaction is related to ICU~     structure and process and to factors related to patients and next of kin. Further, the~     hypothesis will be tested that proxy assessment is possible, i.e. next of kin rate~     satisfaction with care similar to patients.~   "
204073|NCT00890500|"~     The purpose of this research study is to determine the safety and efficacy of a reduced~     intensity conditioning regimen during a double umbilical cord blood unit transplant with one~     of the cord blood units modulated with ProHema.~   "
204074|NCT00890487|"~     The purpose of this trial is to study the effects of the oral supplementation hyaluronic acid~     in menopause women with vaginal distress for treatment vaginal distress.~   "
204075|NCT00890474|"~     Objective: To evaluate moxibustion of the BL67 acupoint between 34 and 38 weeks of gestation~     to facilitate cephalic version of breech presentation in a Western setting. The hypothesis is~     that moxibustion increase the likelihood of cephalic version.~      Design: Randomised controlled trial Setting: University hospital. Population: A total of 212~     consenting women between 34 and 36 weeks of gestation with a single fetus in breech~     presentation will be randomised to moxibustion (n=106) or expectant management (n=106).~      Main Outcome Measure: Cephalic presentation at delivery or before external cephalic version.~   "
204076|NCT00890461|"~     The purpose of this study is to reconstruct a 12-lead electrocardiogram (ECG) from~     intracardiac (IC) electrograms (EGM) obtained from defibrillator devices (ICD). The purpose~     of such a reconstruction is to allow the use of IC EGM for diagnosis of clinical conditions~     for which ECG have historically been used, and to test the feasibility of a reconstruction~     technique for the standard 12-lead or extended electrocardiogram from electrical potentials~     obtained from inside a patient.~   "
204077|NCT00890448|"~     The purpose of this study is to examine the genetic contribution to the mechanism of~     lapaquistat acetate- induced hepatic abnormalities.~   "
204078|NCT00890435|"~     RATIONALE: Gathering information about why patients or their guardians agree or decline to~     participate in the optional pharmacokinetic portion of a phase I treatment study may help~     doctors plan clinical trials in the future.~      PURPOSE: This clinical trial is looking at decision making about participating in~     pharmacokinetic studies in patients enrolled in a phase I treatment clinical trial.~   "
204082|NCT00890383|"~     Background:~      Fluid resuscitation is a cornerstone of the initial management of the critically injured~     trauma patient yet there are numerous controversies surrounding this very common practice. As~     a result, these controversies have been the subject of numerous clinical trials,~     evidence-based guidelines and systematic reviews.~      With the publication of the landmark SAFE Study the equipoise between the 2 treatments (which~     were representative solutions for colloid and crystalloids respectively), 4% albumin and~     saline, was established. This has however been brought into further doubt by the paucity of~     data on the use of hydroxyethylstarches (HES), which are less costly and have less side~     effects than albumin, in trauma. More recent findings by Gruen and colleagues have shown that~     as much as 5% of all trauma deaths are the result of fluid overload based on the North~     American fluid management model for trauma (pure crystalloid fluid management).~      A meta-analysis done by Kern and Shoemaker found that supranormal fluid resuscitation with~     crystalloids is beneficial when given before the onset of organ failure in critically ill~     surgical patients. Balogh and colleagues found out that when supranormal fuid resuscitation~     with crystalloids was applied to victims of severe trauma, this resulted in a statistically~     significant increase in the incidence of mortality, multiple organ failure, intra-abdominal~     hypertension (IAH) and abdominal compartment syndrome (ACS). More recently, Kirkpatrick and~     colleagues reviewed and defined a 'secondary' ACS as a direct result of fluid resuscitation.~     They concluded that excess resuscitation with crystalloid fluids might be harming patients~     and contributing to an increased occurrence of ACS.~      This study will serve as a pilot to test the hypothesis that there will be significant~     differences in clinical outcomes for patients with severe trauma treated with colloid (HES)~     plus crystalloid and crystalloid only fluid management regimens, most notably the incidence~     of IAH and ACS.~      It is hoped that the hybrid colloid (HES) plus crystalloid fluid management regimen will~     provide a means to avoid the untoward fluid overload and/or other complications of pure~     crystalloid fluid management and the costs/complications of albumin administration.~   "
204083|NCT00890370|"~     The study was to evaluate the long term effects, over one year, of five airway clearance~     techniques used by people with cystic fibrosis (active cycle of breathing techniques,~     autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure~     (R-C Cornet and Flutter)). The primary outcome measure was forced expiratory volume in one~     second (FEV1)and the null hypothesis was that there are no differences among the regimens.~   "
204084|NCT00890357|"~     The objective of this study is to identify reasons migraine patients stop using triptan~     medications for abortive headache treatment. It is hypothesized that inadequate education of~     the patient at the time of prescribing the triptan is positively associated with triptan~     discontinuation.~   "
204085|NCT00890344|"~     Low birth weight and prematurity are associated with adverse metabolic outcome in adult life.~     Yet it remains to be determined whether this outcome is the consequence of the low birth~     weight per se, or of the catch up growth achieved in Neonatology units using an early,~     'aggressive' nutritional management. As a matter of fact, 'aggressive' nutrition may promote~     fat mass, rather than lean body mass accretion. Assessment of body composition therefore is~     key to evaluate the efficacy of the nutritional management of these infants. Scarce data is,~     however, available in the literature about the body composition of healthy full-term neonates~     in the first few days of life.~      The aim of this study is to:~        1. Evaluate the feasibility and reproducibility of a safe and non invasive method of~          measurement of infant body composition by Air Displacement Plethysmography (PeaPod).~          Anthropometry and BIA will be used as the reference techniques to assess the accuracy of~          the PeaPod~        2. Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in~          the first few weeks of life~        3. Obtain data on the total body water content of healthy full term infants from BIA.~   "
204086|NCT00890331|"~     Establish the efficacy of a brief, clinic-based prevention program of teamwork coping skills~     for youth and their parents during in a high risk period of early adolescence (11-14 yrs)~     when parental involvement and self-care deterioration occurs.~   "
204087|NCT00890318|"~     The purpose of this study is to determine multiple dose safety, tolerability and~     pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to~     determine the effect of single dose administration of ketoconazole on steady state ABT-072~     pharmacokinetics.~   "
204088|NCT00890305|"~     This clinical trial will be performed in previously untreated patients with metastatic~     colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study~     drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with~     treatment by FOLFOX alone.~   "
204089|NCT00890292|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics~     (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the~     body) after a single dose of JNJ-31001074. Up to three dose strengths will be tested in~     patients 12-17 years old with attention deficit hyperactivity disorder (ADHD).~   "
204090|NCT00890279|"~     This phase II study examines the safety and efficacy of combination therapy for hypertension~     in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines~     the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in~     ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB)~     alone.~   "
204091|NCT00890266|"~     Corneal ectasia is a relative weakness in the structure of the cornea, which produces a~     progressive change in its shape which results in visual distortion. It is known that collagen~     cross-linking in the cornea occurs naturally with age, and in diabetes, both of which seem to~     prevent progressive ectasia. Corneal collagen cross-linking with riboflavin on corneas~     thicker than 400 microns has been shown to stabilize the cornea in keratoconus, and prevent~     progression of the disease.~      The purpose of this study is to determine whether corneal collagen cross-linking with~     riboflavin in a hypotonic solution, with UV light, on corneas less than 400 microns thick,~     leads to stabilisation of corneal ectasia.~   "
204092|NCT00890253|"~     A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a~     de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy~     with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian~     target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to~     investigate the preliminary efficacy in patients with impaired renal function at the~     time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant~     acute rejection within the first 30 days after liver transplantation.~   "
204093|NCT00890240|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics~     (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the~     body) after a single dose of JNJ-31001074. Up to three dose strengths will be tested in~     patients 6-11 years old with attention deficit hyperactivity disorder (ADHD).~   "
204094|NCT00890227|"~     This research is being done to compare two methods of surgery to treat scoliosis and/or~     kyphosis of the spine.~   "
204124|NCT00889837|"~     The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine~     within a day in patients with COPD.~   "
204097|NCT00890188|"~     Colorectal cancer is a major health problem in Western society contributing to a high~     mortality rate. Treatment options for the majority of patients with metastases are limited to~     cytotoxic chemotherapies. The first line chemotherapy containing with oxaliplatin is~     recommend by guideline. The use of antiangiogenic agents, either alone or in combination with~     other therapies may provide an alternative treatment modality in the management of these~     patients. Metronomic chemotherapy refers to the close, regular administration of a~     chemotherapeutic drug, over prolonged periods. The advantages of metronomic chemotherapy~     include reducing acute toxicities and sometimes surprisingly good activity against drug~     resistant tumors via antiangiogenic effect.~      Thalidomide is an agent, which has shown potential in the treatment of hematological and~     solid tissue malignancies such as multiple myeloma via antiangiogenic mechanism.~     Tegafur/uracil (UFUR) is one of the effective chemotherapeutics reported to be an effective~     antiangiogenic agent in an animal model of metastatic colorectal cancers (CRCs).~      In the present study, the investigators will try to use low dose metronomic schedule of~     thalidomide with tegafur/uracil regimen to see the anti tumor efficacy in recurrent and~     metastasis colorectal cancer patients after oxaliplatin-contained chemotherapy.~      The primary endpoints are overall response rate and clinical benefit and the secondary~     endpoint were to determine the progression free survival, and duration of objective response,~     the overall survival (OS) and to assess the safety profile. This is a prospective phase II~     study. After having checked all eligibility criteria, patients will be treated with~     Tegafur/Uracil (TU) regimen. About 34 patients will be enrolled.~   "
204098|NCT00890175|"~     The purpose of this study is to assess the safety of 2 inhaled doses of Staccato Loxapine~     within a day in patients with asthma.~   "
204099|NCT00890162|"~     Background:~        -  Omalizumab is an approved drug for the treatment of asthma by the Food and Drug~          Administration.~        -  Researchers are now studying this drug in a double-blind placebo-controlled manner to~          assess efficacy in patients with idiopathic anaphylaxis (recurrent hypersensitive~          allergic episodes for which a cause is not identified).~        -  The study will improve understanding of the mechanisms involved in anaphylactic~          reactions as a response to the downregulation (a decrease in the number of receptors on~          the surface of cells) in mast cell (a resident cell with several types of tissues)~          activation, and lead to the development of strategies to better prevent or treat~          anaphylaxis.~      Objectives:~        -  To determine whether treatment with omalizumab will reduce or prevent episodes of~          unprovoked anaphylaxis (an acute allergic reaction) in subjects with a history of~          idiopathic anaphylaxis.~        -  To assess pharmacodynamics (physiological effects of a drug) and identify patients with~          undiagnosed mastocytosis (rare disorders caused by too many mast cells).~        -  To investigate cellular and molecular mechanisms of signaling and the effect of~          omalizumab on mast cells or basophils (a cell in the leukocyte family that releases~          histamine, which affects allergic response) and explore other regulatory pathways that~          may be involved with modulation of mast cell degranulation.~      Eligibility:~        -  Patients between 18 and 70 years of age who have been diagnosed with idiopathic~          anaphylaxis, a diagnosis that is made only after other causes of anaphylaxis have been~          considered.~        -  Patients with documented anaphylaxis episodes (mild to severe) at least six times within~          the past 1 year period, at least once within the last 4 months, and with at least one of~          the following:~             -  Elevated serum tryptase above baseline within 2 hours of the event.~             -  Emergency room visit with documented anaphylaxis without a known cause established~               by the acute onset of an illness (minutes to several hours) with involvement of the~               skin, mucosal tissue, or both (generalized hives, itching or flushing, swollen~               lips-tongue-throat) and at least one of the following: (1) respiratory compromise~               or gastrointestinal involvement (shortness of breath, wheeze-bronchospasm, throat~               tightness, low oxygen levels, nausea, vomiting, or abdominal pain); or (2) reduced~               blood pressure or associated symptoms of end-organ dysfunction (collapse, loss of~               consciousness, or loss of bladder or bowel control).~             -  Hospitalization for anaphylaxis.~        -  Patients must provide a letter of referral, with copies of pertinent medical history and~          laboratory tests, from the prospective participant s local physician, and have the~          ability to give informed consent.~        -  Women with childbearing potential must have a negative pregnancy test, and must agree to~          practice abstinence or effective birth control from the start of the protocol and for 3~          months following the last injection of the study drug.~      Design:~        -  Participants will undergo a clinical evaluation, blood tests, and a bone marrow biopsy~          and aspirate.~        -  Participants will be randomized to either drug or placebo and will receive two doses of~          omalizumab or a matched placebo while hospitalized, followed by continued outpatient~          therapy, every 2 to 4 weeks, for up to 6 months.~        -  Participants will remain on the assigned regimen for 6 months or until they have~          experienced new onset of severe adverse event on one occasion within 24 hours of study~          medication that are related to the study drug, whichever comes first. At that time, the~          participant will be discontinued from drug administration.~   "
204100|NCT00890149|"~     This study will evaluate the efficacy of ondansetron + BASICS Plus in reducing severe or~     binge drinking among emerging adults. BASIC Plus (Brief Alcohol Screening and Intervention~     for College Students) has been the most validated brief intervention among college students.~     The BASICS program provides personal feedback, motivation, and strategies that enhance~     normative drinking patterns~   "
204101|NCT00890136|"~     This project aims to characterize the independent effect of domestic endotoxin exposure on~     health status, as well as pulmonary and systemic inflammation, in former smokers with COPD.~     Positive findings from this study would be clinically relevant, as they would provide~     evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD.~     The investigators also hope to make a methodological advance in the field of endotoxin~     exposure assessment by elucidating whether settled dust and/or airborne endotoxin~     measurements are the more relevant exposure of interest in epidemiological studies of~     respiratory disease. To fulfill the specific aims, the investigators will conduct a~     longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air~     monitoring, in-home settled dust collections, home inspections as well as assessments of~     health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.~   "
204102|NCT00890123|"~     The perioperative administration of n-3 fatty acids has been shown to lead to favorable~     effects on outcome in patients with severe surgical interventions by lowering the magnitude~     of inflammatory response and by modulating the immune response. No study with preoperative~     administration of IV omega 3 fatty acids as a part of total parenteral nutrition (TPN) or~     monotherapy with it to demonstrate its effects on inflammatory and immune response has been~     conducted. So, this study has been planned to judge the inflammatory response of preoperative~     monotherapy with IV omega 3 fatty acids in elderly patients undergoing hip surgery~     considering the hyper-inflammation associated with this type of surgery in elderly patients.~   "
204103|NCT00890110|"~     While different lines of evidence support the notion that renal cell cancer is amenable for~     immunologic vaccination, up to now the clinical benefit associated with vaccines has been~     limited. One reason being probably the whole immunological state of the patients with RCC in~     which the tumor releases various substances promoting tolerance of the immune system towards~     the carcinoma. Recent data demonstrates that sunitinib has effects on the immune system which~     might enhance effectivity of anti tumor vaccines.~      Since in kidney cancer it is quite common to resect primary tumor when there are few~     metastasis or or metastatic tumor resected (if there are few metastasis), the investigators~     plan to use these tumor source to grow autologous carcinoma cell lines and use a method used~     world wide for many years and in our institution for over a decade to modify these cells by~     dinitro phenol and use irradiated cell for patients vaccination in combination with sunitinib~     treatments.~      The investigators will monitor clinical and immunological parameters in these patients.~   "
204104|NCT00890097|"~     The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic~     Solution versus Vehicle administered as a topical ocular drop for the treatment for~     geographic atrophy (GA) secondary to age-related macular degeneration (AMD).~   "
204105|NCT00890084|"~     To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk~   "
204106|NCT00890071|"~     The investigators designed this study to determine the predictive value for predicting fluid~     responsiveness of noninvasive evaluation of respiratory variation of peak velocity in~     brachial artery, in mechanically ventilated patients with acute circulatory failure.~   "
204107|NCT00890058|"~     The CIRAS study will investigate postmenopausal breast cancer patients with hand pain and~     compare those receiving aromatase inhibitors (cases) to breast cancer patients with hand pain~     not receiving aromatase inhibitors (controls) in order assess whether this syndrome is an~     inflammatory arthritis.~   "
204108|NCT00890045|"~     Compare the HeRO Vascular Access Device to a conventional ePTFE graft.~   "
204109|NCT00890032|"~     RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body~     build an effective immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating~     patients undergoing surgery for recurrent glioblastoma multiforme (GBM).~   "
204125|NCT00889824|"~     The goal of this project is to provide individuals that have a balance deficit with a device~     that will give them signals that they can feel (vibrations) in order to help them maintain a~     correct sense of balance and perception of place in the environment.~   "
207067|NCT00850902|"~     The purpose of this study is to apply a different incubator humidity strategy at birth to~     decrease morbidity and mortality in extremely low birth (1000 g or less) infants.~   "
204110|NCT00890019|"~     This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63~     ME-TRAP, simian adenovirus encoding Plasmodium falciparum antigens. This follows promising~     phase I clinical studies of MVA ME-TRAP and preclinical studies of AdCh63 and MVA ME-TRAP~     used together in prime-boost regimes. All volunteers recruited will be healthy adults. They~     will be primed with various doses of AdCh63 ME-TRAP administered intradermally or~     intramuscularly. Some of the volunteers will receive a booster vaccination with MVA ME-TRAP~     at various doses administered via the intradermal or intramuscular route. Safety data will be~     collected for each of the eight regimens. Secondary aims of this study will be to assess the~     immune responses generated by each of these regimes.~   "
204111|NCT00890006|"~     The integration of magnetic resonance imaging (MRI) in the treatment planning process for~     prostate cancer will reduce uncertainties in delineation of the prostate gland, and will~     enable delineation of the urethra, penile bulb, and internal pudendal artery. The integration~     of daily cone-beam computed tomography (CBCT) will markedly reduce set-up uncertainties,~     thereby reducing the minimum planning target volume (PTV) margin. By combining MRI simulation~     and daily CBCT, and by adapting radiation delivery accordingly, the investigators will reduce~     dose delivered to the rectum, bladder, urethra, and erectile structures. In this study, the~     investigators seek to determine whether this dose reduction translates to improved patient~     outcomes. In a prospective, 2-stage design, up to 190 patients will be enrolled. In the first~     stage, advanced imaging will be integrated without altering dose planning techniques. Stage 2~     will reduce dose delivered to normal tissues, and will collect toxicity outcome measures.~     This clinical trial will be conducted over 3 years.~   "
204112|NCT00889993|"~     People who eat more dietary fiber have a lower body weight than people who eat less fiber.~     Potential mechanisms include greater feelings of satiety, reductions in food intake, changes~     in blood glucose, insulin, or gut hormones.~      The investigators hypothesize that increasing doses of mixed fiber will influence satiety~     response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent~     manner, when given to subjects in muffins for breakfast.~   "
204113|NCT00889980|"~     There is a significant need to develop new and more effective ways to treat melanoma that~     will decrease patient morbidity and mortality. This protocol intends to collect and process a~     portion (< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical~     SLN resection: the SLN(s) and 1 adjacent non-SLN(s) are planned for study. In addition, blood~     will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and~     appropriate lineage control tissue will be collected. Material only from already-indicated~     and planned procedures as part of standard medical care will be used. The main goal of this~     study will be to properly collect and process material to be analyzed and explore the~     molecular features melanoma biological samples.~   "
204114|NCT00889967|"~     The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for~     Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.~   "
204115|NCT00889954|"~     Patients have advanced stage cancer. This study is a gene transfer research study using~     special immune cells.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Investigators hope that both will work better together. Antibodies~     are proteins that protect the body from diseases caused from infectious diseases and possibly~     cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that~     can kill other cells, including tumor cells or cells that are infected with germs. Both~     antibodies and T cells have been used to treat patients with cancers: they both have shown~     promise, but have not been strong enough to cure most patients.~      T lymphocytes can kill tumor cells but there are normally not enough of them or they are not~     able to kill all the tumor cells. We have done research in which we have grown extra T~     lymphocytes. We have added genes to those T lymphocytes to help them to recognize tumor~     cells. Although the results have been promising, we are still doing more research in this~     area.~      Antibodies usually circulate in blood and are secreted by other cells of the immune system in~     response to the presence of germs or abnormal cells in the body. The antibody used in this~     study is called anti-HER2 (Human Epidermal Growth Factor Receptor 2). This antibody sticks to~     HER2-positive cancer cells because of a substance on the outside of these cells called HER2.~   "
204116|NCT00889941|"~     The purpose of this study is to evaluate whether the size of the pupil has an effect on~     quality of vision in patients undergoing LASIK surgery.~   "
204117|NCT00889928|"~     The study will document being able to successfully remove a subject's gallbladder through the~     vagina (laparoscopic visualization)using a small collection of study surgical tools.~   "
204118|NCT00889915|"~     This study will determine whether two new psychostimulant medications are more effective,~     tolerable, and acceptable than two older medications for treating attention deficit~     hyperactivity disorder.~   "
204119|NCT00889902|"~     The purpose of this study is to:~        1. make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing~          diagnostic sensitivity, specificity, repeatability and validity, so as to effectively~          prompted the early discovery and diagnosis of cervical cancer.~        2. reduce screening costs, screening and benefits into quantitative evaluation, for our~          country to develop cervical cancer prevention and control strategy to provide a reliable~          theoretical basis.~   "
204120|NCT00889889|"~     Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64~     years, plus revaccination~   "
204121|NCT00889876|"~     The objective is to, among obese adolescents, study impact of regular physical activity or~     metformin therapy on nocturnal blood pressure and related cardiovascular disease risk~     factors.~   "
204122|NCT00889863|"~     This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part~     II and the ability to taper steroids in the open label Part I.~   "
204123|NCT00889850|"~     The present study will be conducted in order to compare the bioavailability of 40 mg~     Esomeprazole Mepha (Mepha Ltd., Switzerland) and of INexium 40 mg MUPS tablets (AstraZeneca,~     France) under single dose fasted and fed conditions.~      The study will be conducted as a combined single dose study under fasted and fed conditions~     in a 2x2-period cross-over design with a wash out phase of at least 6 treatment-free days~     between administrations.~   "
204126|NCT00889811|"~     In recent several clinical trials, remote preconditioning showed very powerful myocardial~     protection. However, the myocardial protective effect by remote preconditioning was not~     evaluated on the patients undergoing off pump coronary artery bypass graft surgery (OPCAB).~      The investigators hypothesized that the lower limb remote preconditioning could protect the~     myocardium during the OPCAB. In this study, the investigators will try to evaluate whether~     remote preconditioning could induce myocardial protection on the OPCAB patients.~   "
204127|NCT00889798|"~     The purpose of this registry is to record information on therapy reality of malignant~     lymphatic systemic diseases by office-based haematologists in Germany.~   "
204128|NCT00889785|"~     The proposed research will test a new comprehensive disease management intervention with~     adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents~     subjects with a history of Type 2 Diabetes and a parent caregiver will be consented,~     enrolled, and randomly assigned to either an 6-month intervention (N=44) or a usual care~     comparison (N=44). Recruitment will take place within the Vanderbilt Eskind Pediatric~     Diabetes Clinic. The intervention will include participation in a comprehensive disease~     management program that includes: (1) application of treatment algorithms, (2) phone~     assessment from a diabetes nurse practitioner and dietician to assess barriers and promote~     problem solving, treatment adherence and management, and (3) a behavioral~     Internet-administered self-management problem solving component. Outcomes include~     self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood~     pressure, weight/BMI, and glycated hemoglobin (A1C).~   "
204129|NCT00889772|"~     The purpose of the study is to externally validate the acute lung injury/acute respiratory~     distress syndrome (ALI/ARDS) prediction model (Lung Injury Prediction Score - LIPS) in a~     multicenter sample of patients at risk presented to the acute care hospitals: United States~     Critical Illness and Injury Trials Group (USCIITG).~   "
204130|NCT00889759|"~     The aim of this study is to evaluate the role of high-resolution computed tomography of the~     chest (HRCT) in the investigation of an outbreak of TB that developed in the South Korean~     army.~   "
204131|NCT00889733|"~     The purpose of this study is to determine whether intraperitoneal (IP) Cisplatin combined~     with intravenous (IV) Paclitaxel is well tolerated in women with epithelial ovarian cancer~     who have had neoadjuvant chemotherapy followed by initial debulking surgery.~   "
204132|NCT00889720|"~     It is possible to offer smoking cessation treatment including varenicline to patients~     scheduled for elective surgery. This study will evaluate whether or not this will enable some~     patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may~     lead to reductions in post-operative complication such as wound infections.~   "
204133|NCT00889707|"~     The purpose of this study is to determine whether PRX302 is safe and effective in the~     treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).~   "
204134|NCT00889694|"~     This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to~     investigate whether tripterygium capsule is effective and safe in treating patients with~     ankylosing spondylitis. The investigators expect that the tripterygium capsule is more~     effective than placebo and has few adverse effects.~   "
204135|NCT00889681|"~     This Continued Access Protocol has been written to allow ongoing treatment of subjects at~     selected investigational sites while the marketing application for the Arctic Front®~     Cryoablation System is under review. This study will also allow collection of additional~     safety data following modifications implemented into the Arctic Front® Catheter and~     Cryoablation System.~   "
204136|NCT00889668|"~     Diabetes is a leading cause of death in the Western World with medical costs increasing~     annually. There is no cure for diabetes, and blood glucose monitoring is a key component in~     diabetes treatment and management. Self-monitoring of blood glucose levels is essential to~     the self-management of diabetes and has become widespread over the past decade. Blood glucose~     determinations are currently done by invasive methods (finger tip pricking), followed by~     measuring the blood drop characteristics.~      The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in~     measuring blood glucose levels.~      The rationale for development of the device is to improve the patient's quality of life by~     providing a device that is easily used and provides a painless measurement method, thereby~     leading to higher compliance, and to better managed diabetes~   "
204137|NCT00889655|"~     Prior to colonoscopies, the colon is cleansed using a laxative. Golytely is approved by the~     FDA for this purpose. Another laxative, called MiraLax, is approved by the FDA to relieve~     constipation, but it is not approved specifically for preparation for a colonoscopy.~     Nonetheless, it is commonly used in clinical practice for this purpose, just as is Golytely.~     The purpose of this study is to compare Golytely and MiraLax in two ways: to see whether one~     is better tolerated by patients than the other and to see whether one more effectively~     cleanses the bowel than the other. The investigators' hypothesis is that these 2 bowel~     preparation methods are equally effective in bowel cleansing, but that patients prefer~     Miralax to Golytely.~   "
204138|NCT00889642|"~     The purpose of this study is to evaluate the effectiveness of administering Lidocaine and~     Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy~     adult volunteer subjects undergoing venipuncture.~   "
204139|NCT00889629|"~     People with kidney transplants often develop bone disease. One reason for bone disease may be~     overactivity of a gland in the neck called the parathyroid gland. Overactivity of the~     parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been~     discovered that many patients with kidney transplants have low Vitamin D levels. The~     investigators are examining the effects of doxercalciferol on parathyroid hormone levels,~     proteinuria and bone turnover markers in people who have had a kidney transplant.~   "
204140|NCT00889616|"~     Background:~        -  Globally, the Plasmodium falciparum parasite is responsible for at least 247 million~          acute cases of malaria each year, resulting in about 1 million deaths. Approximately 90~          percent of these deaths, the majority in children under 5 years of age, occur in Africa~          due to infection with P. falciparum.~        -  People living in endemic areas develop natural immunity to P. falciparum as a result of~          repeated infection. Consequently, children who survive to 5 years of age rarely succumb~          to life-threatening disease despite frequent infection. This acquired immunity is~          mediated in part by blood-stage parasite-specific antibodies. Thus, parasite proteins~          expressed during the blood-stage have been proposed as good candidates for inclusion in~          a vaccine.~        -  A number of P. falciparum merozoite antigens have been identified as promising~          blood-stage vaccine candidates, including Merozoite Surface Protein 1 (MSP 1) and Apical~          Membrane Antigen 1 (AMA 1). This Phase I study is the first time that the combination~          vaccine (BSAM-2/Alhydrogel +CPG 7909) will be given to humans. The vaccine will be~          administered in a randomized, open-label (U.S.)/single-blinded (Mali), dose-escalating~          trial.~      Objectives:~        -  To assess safety and reactogenicity of the combination vaccine (BSAM-2/Alhydrogel +CPG~          7909) in malaria-naive U.S. adults and semi-immune Malian adults.~        -  To determine the antibody response of the combination vaccine to the AMA 1 and MSP 142~          proteins, as measured by antibody levels and parasite growth inhibition.~        -  To determine the extent to which the antibody response to the individual antigens (AMA 1~          and MSP 142) is correlated when the combination vaccine is given, and to determine T and~          B cell responses to vaccination.~      Eligibility:~        -  United States: Healthy volunteers between 18 and 50 years, inclusive. Available for the~          52 weeks of the trial and willing to participate in the study as evidenced by signing~          the informed consent document.~        -  Mali: Healthy volunteers between 18 and 45 years, inclusive, and a known resident of the~          village of Bancoumana. Available for the 52 weeks of the trial; willing to participate~          in the study as evidenced by signing the informed consent document or by fingerprinting~          the consent document with the signature of a witness.~        -  Potential participants must meet extensive health and screening requirements to~          participate in this study. Good general health is required as a result of review of~          medical history and clinical testing at the time of screening.~        -  Women who are pregnant or breastfeeding are not eligible.~      Design:~        -  During the 52-week study, participants will receive the first vaccine and complete the~          following:~             -  Physical examination and patient education regarding the signs and symptoms of~               potential adverse effects.~             -  Blood and urine testing, and vital signs (blood pressure, temperature, heart rate,~               and respiratory rate).~             -  United States: Education on the use of digital thermometer, injection-site reaction~               measurement, and malaria vaccine side-effect memory enhancement tool (daily symptom~               diaries).~             -  Mali: Additional blood draws for malaria smear and urine test for chloroquine~               testing.~        -  U.S. and Mali participants will return to the study site on specified days throughout~          the 52 weeks to receive two additional vaccines, record vital signs, complete additional~          blood and urine testing, and review patient education.~        -  U.S. participants will record oral temperature once during the day, as well as pain,~          tenderness, redness, swelling at the injection site and any systemic signs or symptoms~          for 6 days following each immunization.~        -  Participants will receive financial compensation (United States) or food (Mali) to~          compensate for their time.~   "
204141|NCT00889603|"~     The Aricept® Evess study is a prospective, non-comparative, non-interventional study on use~     of Aricept® Evess in the treatment of out-patients with AD and Vascular Dementia. The 24 week~     length of the study aims to collect data from a large number of patients (n= 400) on the~     safety and efficacy at the usual dosage of the product providing an overview of Aricept®~     Evess profile.~   "
204441|NCT00885664|"~     The purposes of this study are:~        1. To understand whether the use of HIV therapy in persons with more advanced HIV disease~          results in greater side effects.~        2. To determine whether these side effects can be related to greater activation of the~          immune system.~   "
204142|NCT00889590|"~     This is a multicenter, randomised phase II trial in patients with high risk GCT.~      Primary objective:~        -  Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of 'high~          risk' GCT as compared to standard care~      Secondary objectives:~        -  Determine the relapse free survival~        -  Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT~   "
204143|NCT00889577|"~     The primary purpose of this study is to evaluate the association between nonalcoholic fatty~     liver disease (NAFLD) by computed tomography (CT) scan and coronary artery disease (CAD)~     measured by the calcium (CAC) score among HIV-infected persons.~   "
204144|NCT00889564|"~     The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular~     Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is~     hypothesized the bacteremia rate associated with the HeRO device will be lower than a~     historical literature control of tunneled dialysis catheters.~   "
204145|NCT00889551|"~     This study intends to observe the epidemiology of pregnancy and growth of adolescent mothers~     and their child in their first year on the development and growth ambulatory at Brasilia~     University Hospital (HUB).~      The study hypothesis is that adolescent growth is disturbed by a pregnancy in this age.~     Another hypothesis is that their child's growth and development could be obstructed.~   "
204146|NCT00889538|"~     This is a double-blind, placebo-controlled crossover study to evaluate the safety and~     efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with~     autism who also have severe behavior problems. The investigators hypothesis is that children~     with autism will show improvement in both learning capabilities and behavior with either~     glutathione, or glutathione, vitamin C and NAC therapy.~   "
204147|NCT00889525|"~     This study was designed to check the efficacy of a new oral medical drug treatment, namely~     Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma.~      Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to~     have the D2 receptor in in vitro studies.~   "
204148|NCT00889512|"~     The purpose of this study is to develop a new protocol using two different types of fertility~     drugs that is more similar to the way the hormones act in a normal menstrual cycle (period).~      We are recruiting women who are trying to get pregnant through In Vitro Fertilization (IVF)~     who either have a high prolactin level (a hormone normally found in your blood that is~     produced in the brain) or have a condition known as hypothalamic amenorrhea in which one does~     not get regular periods due to low hormone levels.~      The ovaries can be stimulated with Follicle Stimulating Hormone (FSH) alone and with FSH and~     Luteinizing Hormone (LH). FSH causes eggs to be made while LH causes estrogen (hormone)~     production. The women in this study have low hormone levels and need both FSH and LH.~     Luveris® (LH hormone) is a new drug approved for egg production and is used in IVF. There is~     no set amount of LH nor a set protocol for LH use. Therefore, we are testing this new~     regimen. One group of women will receive a fixed dose of LH throughout their cycle while the~     other will decrease the dose of FSH while at the same time increasing the LH dose which is~     what happens in the natural menstrual cycle.~   "
204149|NCT00889499|"~     Chronic pain is associated with hypersensitivity of the central nervous system. The drug~     under investigation (tropisetron) has been shown in animal studies to attenuate central~     hypersensitivity. It has therefore the potential to be effective in chronic pain. We compare~     two doses of tropisetron with placebo in patients with chronic pain. We measure pain~     intensity and parameters that assess central hypersensitivity.~   "
204150|NCT00889486|"~     The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate,~     gastroparesis symptoms and health-related quality of life in diabetic patients with~     gastroparesis.~   "
204151|NCT00889473|"~     This study is designed to evaluate the efficacy of a single dose of larazotide acetate in~     preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects~     with celiac disease~   "
204152|NCT00889460|"~     The purpose of this study is to determine the safety and tolerability of several doses of r~     Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.~   "
204153|NCT00889447|"~     This research is being done to study mechanisms of progression of COPD and to develop~     treatments for it. The investigators are doing the present study to identify people age 40~     and older with mild to moderate COPD who will qualify for such studies to include in a~     database. The study will include establishing a screening evaluation or characterization of~     the following two studies:~        -  Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA_00009980~        -  Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease -~          NA_00001771~   "
204154|NCT00889434|"~     -  Working Hypothesis: EGCG and Tocotrienol can act as genetic modifiers and increase the~          level of correctly spliced CFTR transcripts.~        -  Aims of the Study: To determine in patients with CF if oral administration of EGCG and~          Tocotrienol, both separate and in combination, modify CFTR splicing towards normal~          splicing as evaluated by improved Transepithelial Potential Difference (TEPD) assessment~          of chloride secretion.~      To assess the effect of EGCG and Tocotrienol, both separate and in combination, on (1)~     additional TEPD measures of ion channel activity, (2) levels of correctly spliced CFTR mRNA~     in nasal mucosa, (3) cytokine levels in sputum and (4) changes in pulmonary function over the~     course of the study.~        -  Potential Implications to Medicine: Alternative splicing mechanisms are a common cause~          of genetic disease as ~15% of all known human mutations result in defective pre-mRNA~          splicing. Therapies based on augmenting the levels of full length or fully functioning~          proteins may have a substantial impact on the treatment of patients with genetic~          diseases.~        -  Contribution of the expected outcome to society Today genetic diseases can be treated~          but not healed. This proposal may be a step in the direction of finding a cure for~          patients carrying splicing mutations.~   "
204155|NCT00889421|"~     The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment~     of uveitis.~   "
204172|NCT00889200|"~     This study was designed to use a sensitive neuroendocrine probe, the~     Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults~     with insomnia. The primary aim was to assess cortisol reactivity before and after long-term~     (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone~     would result in a significant reduction in plasma cortisol response to the DEX/CRH test~     following treatment of insomnia with standard dose of eszopiclone.~   "
204156|NCT00889408|"~     This is a phase I dose escalation study of DT2219ARL for the treatment of relapsed or~     refractory B-lineage leukemia and lymphoma. Patients will receive a single course of~     DT2219ARL as a 4 hour infusion on days 1, 3, 5, and 8. Weekly follow-up will continue through~     day 29, at which time a disease reassessment will be done. For patients in remission,~     follow-up will continue monthly until disease progression or start of a new treatment.~     Otherwise day 29 will be the final study visit if there is no ongoing toxicity.~      This phase I study will use Continual Reassessment Method (CRM) to establish a maximum~     tolerated dose (MTD) of DT2219ARL. Up to 3 dose levels will be tested with an additional dose~     level (-1) if dose level 1 proves too toxic. The goal of CRM is to identify the dose level~     which correspondences to a desired toxicity rate of 33% or less using grade 3 or 4 capillary~     leak syndrome and any grade 3 or greater toxicity attributed to DT2219ARL as the targeted~     toxicity (based on CTCAE version 4).~   "
204157|NCT00889395|"~     The Mediational Interventions for Sensitizing Caregivers (MISC) model developed by Professor~     Pnina Klein is to enhance the cognitive and social development of children throughout the~     developing world . Although MISC has proven effective in a longitudinal study in two poorer~     communities of Addis Ababa, Ethiopia , it has not been used with HIV households or in the~     Ugandan context where there is desperate need for enhanced caregiving in HIV-affected~     families. We propose to work with community leaders, healthcare workers, and~     parents/caregivers in adapting MISC to the Ugandan cultural and social context in Kayunga.~     For intervention families, MISC training will be added to an ongoing home health care visit~     (HHCV) program already in place for HIV children in Kayunga district. We will then evaluate~     whether MISC parent/caregiver training improves cognitive and psychosocial development in~     their children, and whether clinical stability of the HIV child is an important modifier for~     MISC training benefit.~   "
204158|NCT00889382|"~     This is a multi-center, randomized, open-label, phase 1/2 study of continuous weekly~     paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with~     recurrent/relapsed ovarian and other solid tumors.~   "
204159|NCT00889369|"~     The main objective of this study is to characterize a range of brain activation symptoms~     associated with major depression in peri- and post-menopausal women. Also, assessing brain~     activation before and after the treatment might help to uncover some mechanisms associated~     with the pathophysiology of depression and menopause.~   "
204160|NCT00889356|"~     The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination~     of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days~     in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and~     Amphotericin B 50mg in Vaginal Cream.~   "
204161|NCT00889343|"~     The purpose of this study is to determine whether sorafenib in combination with chemotherapy~     has a positive effect on time to progression of the tumor or death for the treatment of large~     bowel cancer that has already progressed during a first chemotherapy.~   "
204162|NCT00889330|"~     The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.~   "
204163|NCT00889317|"~     Speech develops through a co-structuring of auditory and motor representations, especially in~     the first years of life during language acquisition. In the present study, we will test by~     means of functional magnetic resonance imaging whether vowel perception and production might~     depend on a coordination of auditory and motor, articulatory, cortical maps. The outcome of~     this study will lead to a better understanding of whether both vowel perception and~     production are processed in the human brain and will provide important insight into~     brain-language relationships. Besides new theoretical perspectives on speech perception and~     production, this project might raise important questions concerning patients with speech~     disorders by identifying which aspects of speech perception and production are functionally~     linked.~   "
204164|NCT00889304|"~     Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis~     after open wedge high tibial osteotomy~   "
204165|NCT00889291|"~     Post market observational survey of a vascular access device for access-challenged patients.~     Data collection efforts focused on patient medical and access history and implant procedure~     results.~   "
204166|NCT00889278|"~     The purpose of this study is to determine if higher absolute lymphocyte count in the infused~     stem cell autograft (A-ALC) will lead to an improved antibody response to post-transplant~     immunization with Pneumococcal Conjugate Vaccine and permit effective immunization at 6~     months post-transplant in lymphoma patients receiving Autologous Peripheral Blood Stem Cell~     Transplantation.~   "
204167|NCT00889265|"~     This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane,~     a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation~     of localized alveolar ridge defects on either the maxilla or mandible.~   "
204168|NCT00889252|"~     The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal~     volunteers.~   "
204169|NCT00889239|"~     The objectives of this study are to characterize the clinical performance and wear mechanisms~     of all-ceramic posterior crowns. The wear rate of all-ceramic crowns and opposing enamel in~     selected patients will be quantified. The relationship of each subject's maximum clenching~     force and wear rate will also be analyzed.~   "
204170|NCT00889226|"~     A randomized, open label, dose titration study to evaluate the efficacy and safety of~     Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia~   "
204171|NCT00889213|"~     The purpose of this trial is to determine whether the use of an autologous falciform ligament~     patch combined with fibrin glue will reduce the rate of pancreatic fistula in patients~     completing distal pancreatectomy. The hypothesis for the current trial is: Autologous~     falciform patch closure with fibrin glue will result in a 50% decrease in fistula formation~     postoperatively. The primary end point will be the development of pancreatic fistula using~     the ISGPF definition of pancreatic fistula1. (Drain output of any measurable volume of fluid~     on or after postop day #3 with an amylase content greater than three times serum amylase).~     Secondary end points will include length of postoperative hospital stay, percutaneous~     intervention rates, re-operation rates, morbidity to include delayed gastric emptying, wound~     infection, intraabdominal abscess, postoperative hemorrhage and 30-day mortality.(Bassi C,~     Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study~     group (ISGPF) definition. The Journal of Surgery, 2005;138:8-13).~   "
204173|NCT00889187|"~     The purpose of this research study is to determine if it is possible to deliver high dose~     radiation in one week while also giving the drug capecitabine for the treatment of pancreatic~     cancer prior to surgery, to determine if this treatment can be given safely for the treatment~     of pancreatic cancer prior to surgery and, to determine if this treatment can improve the~     local control pancreatic cancer prior to surgery compared to historical controls of standard~     treatment.~   "
204174|NCT00889174|"~     Background:~      - A leukodystrophy is a disease affecting the white matter of the brain. The white matter~     conducts electricity from one part of the brain to the other. If the insulation, or myelin,~     is damaged, the brain s electrical pathways will not work properly. Researchers are trying to~     identify what causes leukodystrophy.~      Objectives:~        -  To collect detailed clinical characterizations, including histories, physical~          examinations, biochemical tests, genetic studies, and neurophysiologic and neuroimaging~          studies in patients with unclassified leukodystrophies to comprehensively characterize~          such patients and obtain comparative clinical profiles.~        -  To collect detailed clinical characterizations, including histories, physical~          examinations, biochemical tests, genomic and proteomic tissue, and neurophysiologic and~          neuroimaging studies in patients with known leukodystrophies to investigate the~          underlying pathogenesis of these disorders.~        -  To better understand leukodystrophies of unknown cause and to identify the part of the~          DNA of the patient with leukodystrophy that is causing the problem.~      Eligibility:~        -  Any individual with a known or suspected leukodystrophy is eligible to participate in~          this protocol, including~             -  Patients with white matter disease that is unclassified or of unknown cause,~               including but not limited to leukoencephalopathies with calcifications,~               leukoencephalopathies with cysts, leukoencephalopathies with hypomyelination, and~               leukoencephalopathies with brainstem involvement.~             -  Parents or siblings of these subjects.~        -  Exclusion criteria include patients too ill to travel to the Clinical Center and~          patients for whom the leukoencephalopathy is felt to be secondary to an acquired cause~          (for example, traumatic or infectious).~      Design:~        -  Patients will be seen either as an inpatient or outpatient depending on the tests that~          are planned. Patients may need to stay at the Clinical Center for 3 to 5 days.~        -  The following tests will be conducted as part of standard clinical care:~             -  Physical and neurological examinations, including blood and urine tests.~             -  Magnetic resonance based studies to produce a picture of the patient s brain (under~               general anesthesia).~             -  Spinal tap to measure chemicals in the spinal fluid (under general anesthesia in~               young children).~             -  Nerve biopsy, if the peripheral nerves are affected, or muscle biopsy, if the cells~               called the mitochondria or the muscles are involved (both under general~               anesthesia).~        -  The following studies may be performed as part of participation in the research:~             -  Blood, urine, spinal fluid, or muscle to understand the proteins, DNA, and~               molecules in these tissues.~             -  Skin biopsy to grow (in culture) skin cells and to analyze the skin~               microscopically.~             -  DNA studies to find new genes responsible for leukodystrophies and to better~               understand these diseases.~        -  Participation should be based on an interest to help further the research on~          leukodystrophies. Specific information about a patient s present or future health risks~          may not be gained.~   "
204175|NCT00889161|"~     This is a single center, open label forced dose titration study designed to determine the~     tolerability of curcumin in pediatric patients with inflammatory bowel disease (IBD). This~     study will provide initial tolerability and safety data in pediatric patients with IBD.~     Twenty patients with IBD in remission or with mild disease (score <34 on PUCAI or score <30~     on the PCDAI) on sulfasalazine or mesalamine aged 8 to 18 years will be enrolled into this~     study. Each patient will participate in the study for nine weeks. From this study an~     appropriate dosage will be determined to proceed with a double blinded placebo controlled~     study.~   "
204176|NCT00889148|"~     Total hip arthroplasty is amongst the most painful procedures postoperatively, and pain~     management can be a challenge. Different measures have been introduced to manage severe~     postoperative pain in these patients. Previous studies have investigated gabapentin in acute~     postoperative pain and demonstrated reduced postoperative pain, postoperative morphine~     consumption, morphine related side effects, and postoperative pain scores. To date, this~     analgesia adjunct has yet to be investigated for total joint arthroplasty patients.~   "
204177|NCT00889135|"~     This study is designed to supply L-DOPS (droxidopa) on a long term basis to patients with a~     genetic form of profound orthostatic hypotension, most commonly DBH deficiency. It also~     allows us to collect medical history information on this small population of patients that~     would allow us to determine if there are any complications from this type of treatment.~   "
204178|NCT00889122|"~     The purpose of this study is to determine if an interactive game (Dance Dance Revolution/DDR)~     can promote healthy physical activity for the health of all family members~   "
204179|NCT00889109|"~     Shoulder dislocations are common and may result in functionally disabling instability.~     Disruption of the shoulder capsuloligamentous complex during shoulder dislocation is related~     to poor proprioceptive and stabilizing capabilities of the joint. It has been demonstrated~     that surgical restoration of the normal glenohumeral capsular tensioning improves the~     proprioceptive capability of the shoulder and plays an important roll in restoring shoulder~     stability.~      Several studies compared the proprioceptive capabilities of the shoulder between different~     surgical procedures, however only few have used the dynamic unrestricted 3-dimensional arm~     movement model that has been shown to be more appropriate for assessment of glenohumeral~     proprioception. To our knowledge, no previous study has compared proprioception measures of~     the glenohumeral joint following arthroscopic versus open repair for anterior shoulder~     instability, using the 3-dimensional unrestricted arm movement model.~   "
204180|NCT00889096|"~     1. To evaluate the effects of a single oral (80 mg) dose of propranolol on the encoding of~          emotional pictures as assessed by peripheral physiological and electrocortical~          parameters in a healthy population.~        2. To evaluate the effects of a single oral (80 mg) dose of propranolol on the retrieval of~          emotional pictures as assessed by electrocortical parameters in a healthy population.~        3. To evaluate correlations between behavioral data and psychophysiological parameters.~   "
204181|NCT00889083|"~     Multi-organ failure due to sepsis is a major cause of death in critically ill patients. But~     the mechanisms leading to this condition are not fully understood. Mitochondrial dysfunction~     has been shown in skeletal muscle of critically ill septic patients. Liver is very important~     in sepsis as it is responsible of the synthesis of several inflammatory proteins. Moreover~     hepatic failure is associated to a bad outcome.~      The aim of this study is to evaluate the hepatic mitochondrial function in sepsis.~   "
204182|NCT00889070|"~     Assess the burden of disease associated with RSV infection with premature children in an~     outpatient setting.~   "
204183|NCT00889057|"~     Aim of this exploratory phase II study is to assess the clinical activity of sorafenib as~     single agent, in terms of percentage of patients with high grade advanced osteosarcoma free~     from progression following 4 months of therapy~   "
204184|NCT00889044|"~     Since the absorption of clopidogrel through the gastrointestinal tract is limited, we want to~     examine whether adding clopidogrel by chewing will overcome the limited gastrointestinal~     absorption, and hence will improve the prevention of platelet aggregation.~   "
204185|NCT00889031|"~     The purpose of this study is to collect a blood sample in patients with Chronic Lymphocytic~     Leukemia (CLL).~   "
204186|NCT00889018|"~     The purpose of this study is to determine whether an increase in the dose of carboplatin in~     treatment of advanced intraocular (group C and D) retinoblastoma helps in avoiding~     radiotherapy and improves the rate of globe salvage.~   "
204187|NCT00889005|"~     This is a randomized controlled study comparing telephone-based cognitive behavioral therapy~     (CBT) for recent survivors of traumatic events with Acute Stress Disorder (ASD) or acute PTSD~     with a waitlist control group. Survivors with PTSD from both groups will receive face-to-face~     CBT one month from the traumatic event. The study's main hypothesis is that early~     telephone-based CBT will reduce the prevalence of PTSD three and eight months after the~     traumatic event.~   "
204188|NCT00888992|"~     The purpose of this study is to see if automated telephone monitoring will enhance existing~     quitline services, such as Alere Wellbeing's Quit For Life program, and help people quit~     smoking. If successful, this intervention could be incorporated into existing quitline~     protocols and delivered to millions of people who are trying to quit smoking.~   "
204189|NCT00888979|"~     We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine~     exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.~   "
204190|NCT00888966|"~     Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to~     31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA~     is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on~     survival. But the mechanisms underlying these therapy are not clear.~      Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well~     demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a~     clinical setting.~      The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest~     treated with mild hypothermia.~   "
204191|NCT00888953|"~     The aim of the study is to establish the impact of a falls screening questionnaire in the~     adoption of preventive interventions and eventually in the reduction of falls and its~     consequences in elder people living in nursing homes.~   "
204192|NCT00888940|"~     A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to~     Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding~   "
204193|NCT00888927|"~     This study will determine the maximum dose of KW-0761 administered intravenously that can be~     given safely in subjects with previously treated peripheral T-cell lymphoma (PTCL) or~     cutaneous T-cell lymphoma(CTCL)and will see if it is effective in treating the disease.~   "
204194|NCT00888914|"~     The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate~     to severe lateral canthal lines in adults.~   "
204195|NCT00888901|"~     This is a single-center, prospective, controlled study with one eltrombopag treatment group~     and 2 control groups, one on standard steroid treatment, and another one untreated.~      The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on~     shear-induced platelet activation.~   "
204196|NCT00888888|"~     Although many reports have been published on colonic resections in patients with suspected~     appendicitis and the diseases that cause the decision to resect the colon have been~     identified and their proper treatments have been established, there is no report on the risk~     factors present in converting a simple appendectomy into a major colonic resection.~      The investigators aimed to identify the risk factors that lead the surgeon to perform a~     colonic resection in patients undergoing surgery for initially suspected acute appendicitis.~   "
204197|NCT00888875|"~     We evaluate feasibility of fiberoptic intubation through the ILMA Fastrach vs the i-gel.~     Both are airway devices to be introduced in the mouth we the possibility to ventilate the~     patient and furthermore to be a guide to introduce a tracheal tube. We first insert either~     the ILMA or the i-gel. In a second step, we will introduce a tube through the device, all~     guided visually through a fiberoptic tool which works as a railroad for the tracheal tube.~   "
204198|NCT00888862|"~     The main objective of this study is to characterize a range of brain activation symptoms~     associated with depression and response to treatment in midlife men and women with MDD, using~     MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine~     whether these brain activation symptoms are related to menopausal symptoms (i.e., hot flashes~     and night sweats). Also, assessing brain activation before and after the treatment might help~     to uncover some mechanisms associated with the pathophysiology of depression and menopause.~   "
204199|NCT00888849|"~     This study is being conducted to compare surgical and patient outcomes across stapled (Group~     II) versus hand-sutured (Group I) groups.~   "
204200|NCT00888836|"~     It is generally held that ß-cell function is irreversibly lost already at the time the~     disease manifests itself and thereafter continues to decline linearly with time. Several~     studies, however, have documented the possibility that ß-cell function may be restored, at~     least partially, in type 2 diabetes. Of major relevance to the issue of ß-cell recovery in~     diabetes are the following findings:~        -  bariatric surgery in morbidly obese patients with type 2 diabetes can restore~          euglycaemia, the acute insulin response to glucose and insulin sensitivity;~        -  recent studies have reported that diabetic subjects return to euglycaemia and normal~          insulin levels within days after surgery, long before a significant weight loss has~          occurred; and~        -  whereas gastric bypass (GBP) improves insulin sensitivity in proportion to weight loss,~          bilio-pancreatic diversion (BPD) improves insulin action out of proportion to weight~          loss, i.e., it normalizes it at a time when patients are still markedly obese. Because~          RYGB is a predominantly restrictive procedure involving the foregut, whereas BPD is a~          predominantly malabsorptive procedure involving the distal gastro-intestinal (GI) tract,~          these findings suggest that the control of both insulin action and ß-cell function is~          influenced by signals originating from the GI tract.~      The principal aim of this study is to verify the effect on type 2 diabetes mellitus (T2DM) of~     GBP and BPD, the two operations which have shown specific actions on glucose homeostasis~     control, in type 2 diabetic patients with BMI > 35 kg/m2, and to compare this effect with~     matched T2DM control patients receiving the standard of medical care.~   "
204201|NCT00888823|"~     A new type of treatment called stereotactic radiotherapy has recently been developed in hopes~     of improving the success of the treatment and improving the convenience to patients, while~     reducing the side effects. This study is developing stereotactic radiotherapy as a~     state-of-the-art treatment for lung cancer patients.~   "
204202|NCT00888810|"~     The objective of the trial was to evaluate the efficacy of the association of topotecan and~     lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.~   "
204203|NCT00888797|"~     Colon and rectal cancer is the second most prevalent malignant disease in the western world,~     causing significant morbidity, mortality, and healthcare sources use. Treating colon and~     rectal cancer with curative intent generally includes resection of the primary tumor. Despite~     its crucial role, surgery by itself induce physiological changes resulting in significant~     immune depression and other physiological perturbations, which may in turn play a significant~     role in the initiation of new metastases and the progression of pre-existing dormant~     metastases. The aim of this study is to assess the use of perioperative medical intervention~     using a combination of a β-adrenergic blocker (Propranolol) and a COX2 inhibitor (Etodolac),~     in order to attenuate the surgically induced immunosuppression and other physiological~     perturbations, aiming to reduce the rate of tumor recurrence and distant metastatic disease.~   "
204204|NCT00888784|"~     The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of~     beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal~     (GOV2 or IGV1) rebleeding and improvement in survival.~   "
204205|NCT00888771|"~     Prospective study of accuracy of colonic polyp characterisation in vivo using high resolution~     white light endoscopy, narrow band imaging and chromoendoscopy.~   "
204206|NCT00888758|"~     The primary objective of this study is:~        -  comparison of a safety and effectiveness of third generation DES (biolimus A9 and~          everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of 9~          month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in both~          groups.~      The secondary outcomes are a comparison of (using OCT):~        -  number of uncovered stent struts~        -  number of malapposed stents struts~        -  in-stent neointimal volume~        -  in-segment assessment of vessel wall response to DES~   "
204207|NCT00888745|"~     This is a Phase I multicenter study that will be conducted in the United States and Europe.~   "
204208|NCT00888732|"~     The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin~     analogues will improve post prandial glycaemic control in patients with type 1 diabetes~   "
204209|NCT00888719|"~     Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate~     optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks~     to type 2 diabetes patients who are insufficiently controlled by diet and exercise in~     comparison to placebo.~   "
204210|NCT00888706|"~     The purpose of the study is to determine whether individualized social activities, physical~     resistance training and walking, and a combination of both are effective in improving~     nighttime sleep in elders with dementia.~   "
204211|NCT00888693|"~     Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the~     maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with~     an atypical antipsychotic.~   "
204212|NCT00888680|"~     The study is being conducted to explore the safety and effectiveness of a new chemical~     entity, BGC20-1531, in subjects with a history of migraine. In this study subjects will treat~     a total of three migraine attacks with two different doses of BGC20-1531 and placebo, with at~     least one week wash out period between doses.~   "
204213|NCT00888667|"~     The study will be a prospective cohort study of 20 patients recruited from site's~     Defibrillator Clinic patient population who are followed at the site.~      Hypothesis: Among the available EGM configuration options, one is better than the others for~     detection enhancements purposes.~   "
204214|NCT00888654|"~     RATIONALE: The use of diindolylmethane, a substance found in cruciferous vegetables, may slow~     the growth of tumor cells.~      PURPOSE: This phase II trial is studying how well diindolylmethane works in treating patients~     with stage I or stage II prostate cancer undergoing radical prostatectomy.~   "
204215|NCT00888641|"~     Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In~     preparation for a definitive randomized controlled trial this pilot study will assess~     feasibility and variance data to be used for sample size estimation~   "
204216|NCT00888628|"~     The purpose of the study is to learn if islet transplantation is an effective treatment for~     Type 1 diabetes in people who have had a kidney transplant.~      The primary objectives of the study are:~      - To set up islet transplantation in patients who have had a kidney transplant and who are~     using an immunosuppressive regimen that works~      The Secondary objective of the study is:~        -  To find out if successful islet transplantation leads to improved metabolic control and~          reduced renal complication from diabetes~   "
204217|NCT00888615|"~     This phase II trial studies how well elesclomol sodium and paclitaxel work in treating~     patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer~     that has returned after a period of improvement (recurrent) or is persistent. Drugs used in~     chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Elesclomol sodium may also help paclitaxel work better by~     making tumor cells more sensitive to the drug.~   "
204218|NCT00888602|"~     This is an open label, single use, randomized, 4-period cross-over study. In each period,~     subjects will receive one of 4 test combinations. Blood will be drawn prior to study product~     consumption and following study product consumption for glucose measures.~   "
204219|NCT00888589|"~     The purpose of this study is to compare two types of radioactive drugs to see if they provide~     the same or different information about any disease that may be present in the participants~     breast.~   "
204220|NCT00888576|"~     The purpose of this study is to develop a registry with safety and efficacy data on the use~     of etanercept in clinical practice in Taiwan.~   "
204221|NCT00888563|"~     Background:~        -  People with many different diseases have symptoms of fatigue, which is a general sense~          of tiredness; however, the causes are not fully understood. Fatigue symptoms may be~          related to a person s level of fitness, health, and blood chemistries.~        -  Researchers are studying the potential role of plasma cytokines (signaling molecules)~          and hypothalamic-pituitary-adrenal (HPA) axis (part of the neuroendocrine system that~          controls stress) functioning in symptoms of fatigue.~      Objectives:~        -  To characterize the symptoms of fatigue in healthy individuals.~        -  To collect information on fatigue, pain, depression, stress, sleepiness, and quality of~          life from healthy adults of all ages.~        -  To compare results obtained from people with various illnesses to better understand~          possible causes of fatigue that are associated with those diseases.~      Eligibility:~        -  Physically and mentally healthy volunteers18 years of age or older who can speak and~          read the English language.~        -  Exclusion criteria include individuals with a disease or condition causing significant~          fatigue (congestive heart failure, cancer, or sleep disorders), individuals taking~          medicines that cause fatigue (beta blockers, diuretics, or narcotics), and individuals~          who have a major psychiatric condition (major depression, anxiety disorder, or~          schizophrenia).~        -  The following individuals may not participate: those who have two more alcoholic drinks~          per day, who use illicit drugs, or who drink more than 4 cups of coffee, 8 cups of soda~          or tea, or similar amounts of other caffeine-containing beverages a day, or eat more~          than 1 pound of chocolate per day; and individuals who worked evenings or night shifts~          in the past month.~        -  Women who are pregnant or breastfeeding are not eligible.~      Design:~        -  Participants must make two outpatient visits to the Clinical Center. Each visit will~          last 5 hours and participants must refrain from smoking and consuming alcohol and~          caffeine for at least 24 hours.~        -  During the first study visit, researchers will conduct the following tests:~             -  Psychiatric interview, medical history, pregnancy test, and drug test.~             -  Urine test to measure the levels of stress hormones.~             -  Questionnaires that measure fatigue, pain, depression, stress, daytime sleepiness,~               and activity.~             -  Physical fitness test, including strength tests, walking tests, and physical~               activity monitoring.~        -  Before the second study visit, patients must refrain from smoking and consuming caffeine~          and alcohol for at least 24 hours and have nothing, even water, by mouth after midnight.~          During the second study visit, the following tests will be conducted:~             -  Stress hormone test (participant will receive a cortisol-releasing hormone).~             -  Four intravenous blood draws to determine cytokine profiles, gene expression, and~               levels of stress hormones (immune and gentic analysis).~        -  Participants will receive a small financial compensation for participation in the study.~   "
204222|NCT00888550|"~     Two standards of care exist with regards to posterior splinting post-operatively. The~     proponents of splinting feel the additional immobilization decreases the stress on the soft~     tissue, subsequently preventing or limiting pain while improving early range of motion (ROM).~     The opposing belief is that the splinting is without therapeutic benefit and that early~     mobilization is beneficial. With regards to both practices, the surgeon's practice is~     anecdotally based on past experience.~      The purpose of this study is to compare the results obtained with and without posterior~     splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence~     based reasoning to guide future practice.~   "
204223|NCT00888537|"~     Patients who are hospitalized because of a heart attack are prescribed a number of medicines~     to help the heart heal. The investigators will examine different ways in which clinicians~     share information about those treatment options with patients and the impact that this can~     have on patients' choices and health.~   "
204224|NCT00888524|"~     Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of~     evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR)~     on pain, physical disability and general health state.~      Materials and methods: Randomized, double-blind, controlled trial (therapists and assessors)~     involving 46 persons with CLBP over 15 weeks with two interventions, presented three times a~     week. Each group received EBP (personalized exercise program, manual therapy and health~     education) while one group performed supplementary 20 min sessions of DWR at the~     individualized aerobic threshold. Measurements were made pre and post intervention for pain,~     disability and general health. Range of motion of lumbar spine in the sagittal plane, maximum~     isometric strength and muscle endurance of lumbar and hip extensors was assessment.~   "
204225|NCT00888511|"~     The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in~     inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the~     phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy~     (2 Gy x 33 F, 5 F per week).~   "
204226|NCT00888498|"~     The purpose of this study is to determine the effect of using ankle manual therapy procedures~     on clinical outcomes in individuals with post-acute ankle sprains.~   "
204227|NCT00888485|"~     The purpose of this study is to determine the possible preventive effect of behavioural~     modification versus standard treatment after hospital discharge in CHD patients.~   "
204228|NCT00888472|"~     Extracorporeal leukocytapheresis (LCAP) or granulocytapheresis (GCAP) has been used in the~     treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown~     promising safety and efficacy. LCAP and GCAP seem to be effective for steroid-resistant~     inflammation. The investigators have already reported safety and efficacy of GCAP in~     refractory asthma and expect the beneficial effect of LCAP in refractory asthma. In this~     study, in order to improve the therapeutic effect of LCAP by increasing the quantity of~     leukocytes that were removed, the investigators conducted a clinical study to investigate~     safety and efficacy of high-dose LCAP performed using a larger filter and an increased dose~     of the blood volume per body weight treated, as an possible therapy for refractory asthma.~   "
204229|NCT00888459|"~     The investigators are hypothesizing that by offering both self-help materials and mailed~     nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users,~     as well as decrease tobacco withdrawal.~   "
204230|NCT00888446|"~     This phase 2 study will evaluate the safety, immunogenicity and optimal timing of two~     injections at three dose levels of the tgAAC09 vaccine in healthy volunteers. Study~     volunteers will receive two intramuscular injections of tgAAC09 or placebo at Months 0 and 6~     (groups A, C, E and G) or at Months 0 and 12 (groups B, D and F) and be followed for a total~     of 18 months following the first injection with the exception of group G in which volunteers~     will be followed for 12 months after the first injection (6 months after the second~     injection). This study will explore whether boosting is possible, and compare a shorter and~     more practical six-month time interval with a twelve-month time interval.~   "
204231|NCT00888433|"~     An international, multi-center, prospective, randomized, controlled study of the safety and~     effectiveness of renal denervation in patients with uncontrolled hypertension.~   "
204232|NCT00888420|"~     This study is undertaken to assess and improve the existing patient flow, or so-called~     throughput process, in an adult outpatient pain treatment clinic.~   "
204233|NCT00888407|"~     The purpose of this study is to design an intervention to increase hepatitis B (HBV)~     screening among Hmong Americans.~   "
204234|NCT00888394|"~     MAIN OBJECTIVE: To value the effectiveness of the different quiropody interventions in the~     heel pain.~      SECONDARY OBJECTIVES: To evaluate the effectiveness of lasw different technologies in front~     of each one of the other experimental technologies. To analyze the state of general health~     and of quality of the patients' life in all the treatment groups. To analyze the study~     cost-effectiveness of each one of the experimental interventions. DESIGN: randomized~     controled trial, prospective.~      SUBJECT OF STUDY: Patient that go to the Assistance Educational Unit of Podología of the E.U.~     Sciences of the Health with footpain like consultation reason.~      INTERVENTION: Establishment of four experimental groups with intervention varied podológica.~     He/she will be carried out a complete pursuit with valuations at the 1,2, 6, 12 and 24~     months, by means of pain scales and function of the foot (FHSQ), the index postural of the~     foot (FPI), the study of pressures by means of biofoot/IBV and of the state of general health~     (SF-12) and quality of life (Euroqol).~      VARIABLES: Of intervention; treatment basic orthopodiatry, treatment advanced orthopodiatry,~     of treatment quiropody. Of result: pain and function of the foot (FHSQ), of the state of~     general health (SF12) and quality of life (Euroqol). Variables of characterization of the~     sample.~      ANALYSIS DATA: Descriptive statistic, with measures of central tendency and dispersion of the~     study variables. They will be carried out statistical inferenciales between the main~     variables of intervention and result (square chi, t Student, ANOVA, Mann-Whitney, Wilcoxon,~     according to types and normality of variables). Likewise, measures of the size of the effect~     will settle down in the main variables of result, by means of the relative reduction of the~     risk, absolute risk and odds ratio, with their respective intervals of trust.~   "
204235|NCT00888381|"~     The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation~     of the Enzira vaccine.~   "
204236|NCT00888368|"~     The purpose of this study is:~        -  To determine the accuracy of intraarticular placement with the transpatellar tendon~          approach as compared to the suprapatellar approach. Patients undergoing knee arthroscopy~          will be consented for study of the injection of the fluid into the joint prior to portal~          placement or commencement of knee replacement. Patients will be randomized to receive~          injections via the transpatellar tendon or superolateral approach. Using injectable~          contrast and fluoroscopy, the placement of injections into the knee will be evaluated~          for accuracy. Injection attempts with contrast fluid that uniformly coats the articular~          surface on sagittal and coronal radiographs will be counted as successful. A~          concentration of contrast fluid in extraarticular fat will be counted as a failure.~      Hypothesis: The rate of accuracy of intraarticular placement of the needle tip via the~     transpatellar tendon approach to knee aspiration is greater than that of the superolateral~     approach.~        -  To determine the distribution of contrast material with the transpatellar tendon and~          superolateral apporaches. Using a previously described evaluation technique of dividing~          the knee into seven compartments, sagittal and coronal fluoroscopy images will be~          evaluated to determine the distribution of contrast fluid.~      Hypothesis: Contrast injected into the knee via the trasnpatellar tendon approach will~     penetrate as many compartments of the knee as contrast injected via the superolateral~     approach.~   "
204238|NCT00888342|"~     Respiration failure type 2 is loss of the lungs ability to take up oxygen (O2) and get rid of~     carbon dioxide (CO2). The diagnosis is based on blood gas measurement of pressures of O2 and~     CO2. Patients with COPD is often seen to have co-morbidity with cardiac diseases. Chronic~     systemic inflammation is seen in both COPD and cardiac diseases. The investigators will~     investigate the sleep quality, CO2-retention, O2-saturation, cardiac arrythmias and markers~     of inflammation in 120 patients with COPD in different stages of the disease. Our hypotheses~     are:~        -  that the first signs of respiration failure type 2 is seen during sleep with alteration~          of sleep patterns and greater and more long-lasting retention of CO2 in the blood~          compared to those with a normal lung function~        -  that the use of alcohol, zopiclone or supplementary oxygen will make these differences~          even greater~        -  that cardiac arrythmias correlates with hypoxemia~        -  that cardiac arrythmias and respiration failure correlates with degree of inflammation~   "
204239|NCT00888329|"~     The purpose of the study is to determine whether 40 mg aprepitant administered before surgery~     is effective for preventing vomiting in the first 24 hours after surgery in women undergoing~     elective hysterectomy.~   "
204240|NCT00888316|"~     RATIONALE: Learning about the effect of excess iron in the liver of patients undergoing donor~     stem cell transplant may help doctors plan treatment.~      PURPOSE: This study is investigating the effects of iron overload in patients undergoing~     donor stem cell transplant.~   "
204241|NCT00888303|"~     The purpose of this study is to evaluate the efficacy of 8 mg of dexamethasone administered~     prior surgery, to reduce pain, postoperative nausea and vomiting and to improve vocal~     function after thyroidectomy for benign disease.~   "
204242|NCT00888290|"~     This study will enroll 25 patients with kidney disease to evaluate the effects of different~     doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney~     function and muscle strength. The investigators will also evaluate safety and tolerability of~     different doses.~   "
204243|NCT00888277|"~     This study is designed to identify a brief screening evaluation for MS patients that is~     sensitive and specific to the MS population and which correlates with the findings of our~     standard-of-care neuropsychological assessments.~   "
204244|NCT00888264|"~     The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II~     Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and~     clinical evaluation will be recorded and potential differences that may exist due to~     epidemiological factors or comorbidities will be analyzed.~   "
204245|NCT00888251|"~     This retrospective chart review and data abstraction will evaluate and quantify the~     effectiveness of a comprehensive weight management program. The hypothesis is that the~     program will positively affect weight, weight-related comorbidities and medication use.~   "
204246|NCT00888238|"~     This study will evaluate the effect of a single dose of sitagliptin on glucose dependent~     insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG)~     procedure.~   "
204247|NCT00888225|"~     Epi-X is a multicentered randomized controlled clinical trial of chronic lateral~     epicondylitis with parallel group design and two phases. In the first phase physical exercise~     treatment is given in the intervention group and expectance in the reference group. In phase~     2 eccentric exercise versus concentric is tested.~   "
204248|NCT00888212|"~     The purpose of this study is to evaluate the yield of endoscopic guided fine needle~     aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial~     endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis~     stage I-II; but in whom the preceding bronchoscopy did not result in a qualifying diagnosis.~   "
204249|NCT00888199|"~     The purpose of this clinical trial is to determine if the experimental Tensegrity prosthetic~     foot offers a reduction of the amount of oxygen used while walking, if stability is improved~     over current prosthetic feet, and whether the experimental device actually increases activity~     in amputees.~   "
204250|NCT00888186|"~     The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's~     disease appearing at different levels of levodopa infusion dose. The hypothesis is that~     different dyskinesias (dystonia, chorea) correlate to different levels of levodopa~     concentrations, as detected in plasma.~   "
204251|NCT00888173|"~     This phase II trial is studying how well brivanib alaninate works in treating patients with~     endometrial cancer that has come back (recurred) or is persistent. Brivanib alaninate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the tumor.~   "
204252|NCT00888160|"~     Early fixation of unstable fractures of the femur, pelvis, and acetabulum reduces some~     complication rates. However, in patients with multiple injuries, the optimal treatment of~     skeletal trauma may be affected by severe injury to the head, chest, or abdomen. The~     relationship between associated injury severity and the timing of definitive management of~     unstable fractures is not well-understood. The practice of early total care, early~     definitive fracture management, has been criticized by some, who have suggested that~     additional hemorrhage with surgery may be associated with a deleterious systemic inflammatory~     response. The alternative extreme of damage control orthopedics (DCO) has been recently~     proposed as a means of providing provisional stability of major skeletal injury, generally~     through external fixation. It is speculated that DCO will diminish the potential for systemic~     compromise. However, the need for further (definitive) surgery on a delayed basis, and the~     potential additional complications and costs associated with this strategy are controversial.~     The investigators' goals are to define which injuries or parameters warrant delay of~     definitive orthopaedic care, and to determine what time interval for fracture fixation~     promotes optimal patient outcome. The investigators will assess the effects of fracture~     fixation on head injury, chest injury, abdominal injury, mortality, complications, patient~     outcomes, and costs.~   "
204279|NCT00887783|"~     This study is an open label randomized multi-centre phase II trial in patients with~     inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general~     criteria for curatively intended irradiation. The treatment plan consists of two courses of~     inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day~     1 of the last induction chemotherapy has been given. The patients will be included in the~     study after completing the induction chemotherapy. Randomization will take place only if an~     acceptable dose plan can be obtained.~   "
204253|NCT00888147|"~     During radiation treatment for head and neck cancer a large percentage of patients at Mayo~     Clinic Rochester develop the need for tube feeding to meet nutrition and hydration needs.~     These patients are usually taking pain medication along with a stool softener or laxative.~     Currently, when these patients get a feeding tube it is our standard practice to choose a~     fiber-free enteral tube feeding formula as to not worsen their constipation. Currently, there~     are no guidelines as to which patients are good candidates for fiber containing enteral tube~     feeding formulas. The investigators hope this study will help determine if fiber containing~     enteral tube feeding formulas can be used for patients undergoing radiation for head and neck~     cancer without increasing rates of constipation or increasing use of stool~     softeners/laxatives.~      Hypothesis: Participants enrolled in the study will not have increased rates of constipation~     on fiber-containing enteral tube feeding formula compared to historical standards on~     fiber-free formula.~   "
204254|NCT00888134|"~     The purpose of this research study is to determine if selumetinib is safe and effective in~     treating patients with cancers with a mutated BRAF gene. Selumetinib is an investigational~     drug that works by blocking a protein called MEK, which is known to play a role in the growth~     of cancer cells lines and tumors that have a mutated BRAF gene. There are multiple types of~     cancers that have mutations in the BRAF gene and depend on the activity of this gene for~     their growth and survival.~   "
204255|NCT00888108|"~     This is a Phase 1 open-label study evaluating the safety of ABT-263 when combined with a~     standard and weekly regimen of docetaxel in subjects who have solid tumors with measurable~     disease.~   "
204256|NCT00888095|"~     The aim of this study is to analyze the effects of two different targets of deep brain~     stimulation: caudal Zona incerta and Nucleus subthalamicus. The present study will~     investigate the effects of DBS using a blind, randomized and stratified design in patients~     with Parkinson's disease.~   "
204257|NCT00888082|"~     Primary objective of this study is to determine the effectiveness of goserelin acetate~     (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant~     chemotherapy for primary invasive breast cancer by documenting persistence or resumption of~     regular menses via menstrual history, serum FSH and E2 measurements.~      The secondary objectives of this study are as follows: To investigate the impact of treatment~     with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of~     ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and~     to compare safety and tolerability of study drugs in two treatment groups by evaluation of~     adverse events.~   "
204258|NCT00888069|"~     This study will investigate how the levels of a single dose of CTAP101 changes in the body~     over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances~     (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with~     vitamin D insufficiency and secondary hyperparathyroidism (SHPT).~   "
204259|NCT00888056|"~     Alzheimer's Disease (AD) is the most common cause of dementia for which no treatment has~     shown consistent efficacy to stop or slow down the disease. Recent report of enhancement of~     memory abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the~     hypothalamus suggests that neuromodulation of circuits involved in memory processes may have~     therapeutic implications in AD patients with memory decline.~      The primary objectives of this prospective, non-controlled, pilot study are to evaluate the~     feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and~     to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD~     (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and~     specific impairment of episodic memory will be included in a 2-year period. The evaluation~     criteria for feasibility will be the proportion of patients undergoing the procedure, chronic~     stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated~     using numerous cognitive and memory testing. Changes in behavioral and mood scales, and~     changes in hypothalamic functions (clinical, biological and hormonal assessment) will~     evaluate safety and tolerance. Clinical, neuro-psychological, biological and imaging~     assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery.~     Bilateral electrodes (Medtronic 3389) will be implanted, by MR-guided frame-based stereotaxy,~     in the hypothalamic part of the fornix, and then connected to the generator (Kinetra,~     Medtronic). Chronic high-frequency stimulation will be delivered immediately after surgery.~      The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and~     ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to~     AD patient the possibility to slow down/stabilize their symptoms, which no other treatment~     can currently offer, and to increase their quality of life.~   "
204260|NCT00888043|"~     The purpose of this research study is to find out what side effects the combination of the~     two study drugs, bevacizumab (Avastin) and CNTO 95 have on the body and to determine the~     highest dose of CNTO 95 that can be given with bevacizumab that is safe and well tolerated.~   "
204261|NCT00888030|"~     End-stage renal disease is a global epidemia with an estimated incidence of 7% per year and~     high morbidity-mortality rate. Early detection of chronic kidney disease (CKD) and~     intervention for CKD complication is important to retard renal progression. However,~     traditional uremic toxin or small water-soluble molecules are poorly correlated with the~     renal function, uremic symptoms and outcomes of CKD patients.~      Putative protein-bound solute, p-cresol, is accumulated in ESRD patients receiving dialysis~     therapy. This uremic solute was associated with endothelial dysfunction, immune dysregulation~     and can predict outcome in hemodialysis patient. P-cresol inhibits endothelial cell~     proliferation and endothelial response to inflammatory cytokines. In vitro, p-cresol~     decreases leukocyte transendotherliar migratory function and inhibit production of phagocyte~     reactive species. Clinically, p-cresol plays a pathophysiological role in the uremic~     toxicity. High free serum level of p-cresol is associated with mortality in hemodialysis~     patients.~      Information of p-cresol in CKD patients is not available. The investigators hypothesized~     p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity-~     mortality of CKD patients.~      Value of p-cresol in different stages of CRF is still unknown. Information of p-cresol in CKD~     patients is not available. The investigators hypothesized p-cresol can be accumulated in~     early CKD and have a positive correlation with the morbidity- mortality of CKD patients.~      The principal aim of this prospective cohort study is to investigate the association between~     total serum levels of p-cresol and the glomerular filtration rate. The correlation of level~     of p-cresol and morbidity-mortality in CKD patients will be also evaluated.~      To determine the relationship, patients of nephrology clinic with a diagnosis of CKD were~     enrolled in this prospective study and follow-up for 1-year period. The association between~     total and free serum levels of p-cresol and the glomerular filtration rate were evaluated in~     CKD patients. The p-cresol level was correlated with other many inflammatory markers (white~     blood cell counts, ferritin, hs-crp, leptin) and also with the hospitalization rate secondary~     to cardiovascular and infectious event. The renal outcome and all-cause mortality was~     assessed. Determination of this relationship can help to establish an accurate marker for~     early detection of CKD and also its prognostic role in CKD patients.~   "
204280|NCT00887770|"~     This study is being performed to investigate the potential for AZD5672 to affect the~     electrical conduction pathways in the heart. AZD5672 will be compared against a drug~     (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the~     electrical conduction of the heart.~   "
204281|NCT00887757|"~     This is a Phase 1 open-label study evaluating the safety of navitoclax (ABT-263) when~     combined with a standard regimen of gemcitabine in approximately 50 subjects with solid~     tumors and measurable disease.~   "
204282|NCT00887744|"~     The primary purpose of the study is to measure the change in severity of symptoms and ability~     to function in every day activities in patients suffering from degenerative lumbar spinal~     stenosis after treatment with the Aperius® device.~   "
204262|NCT00888017|"~     Previous research studies have shown that there may be a connection between proton pump~     inhibitor therapies and hip fracture in adults(1). Proton pump inhibitor(PPI) reflux~     medications raise the pH of the stomach, which may effect the body's ability to absorb~     certain calcium compounds.~      Neonates are at a crucial age for bone mineralization. Because esophageal reflux is common in~     neonates, PPI therapy is commonly used, despite little information on effectiveness and side~     effects. PPIs work by blocking the production of protons in the pumps in the stomach, thus~     making the stomach less acidic. The calcium ion needs an acidic environment in order to be~     broken down from its natural compounds into an absorbable form (2). This is troubling because~     of the problems associated with osteopenia in neonates. Bone mineralization is important for~     premature infants. Rickets and bone fractures are higher in preterm infants than term~     infants. For this reason, we are investigating whether there is a connection between PPI~     therapies (specifically Prevacid) and decreased bone densities in neonates.~      The objective is to determine if a connection exists between proton pump inhibitor antacids~     and decreased rate of bone mineralization in neonates.~   "
204263|NCT00888004|"~     This study will evaluate the safety and efficacy of administration of AFQ056 in combination~     with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease~     patients.~   "
204264|NCT00887991|"~     This is a randomised controlled trial investigating the performance of two, 'state of the~     art' electric breast pumps in mothers who have delivered preterm infants. The main data~     collection period will be up to day 10 post delivery data. Data collected will include a~     record of the weight of milk produced during the first 10 days and a short questionnaire to~     find the mothers' opinions of the pumps used. On Day 5 a timed and weighed expression of 15~     minutes will be carried out. After the first 10 days, mothers will be asked to collect brief~     information on their continuing use of their pumps and subsequent duration of breast and~     bottle feeding, mothers will be contacted at 3 and 6 months post-term~   "
204265|NCT00887978|"~     This study is an international, multi-center, randomized, double-blind, placebo-controlled~     study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e.,~     endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur~     at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk~     test. Study procedures include routine blood tests, medical history, physical exams, disease~     evaluation, and exercise tests.~      Patients who complete all assessments for 16-weeks will also be eligible to enter an~     open-label, extension phase study (FREEDOM - EXT).~   "
204266|NCT00887965|"~     To characterize the effects of discontinuation of denosumab therapy on variables of bone~     histology in postmenopausal women with low bone mass or osteoporosis. Patients who have~     received denosumab and completed study 20050179 (NCT00293813), completed study 20050141~     (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791)~     but did not enroll in study 20060289 (NCT00523341) will be included in this study. Patients~     who will participate in the off-treatment imaging study for 20080747 (NCT00890981) are also~     eligible.~   "
204267|NCT00887952|"~     The aim of this multicenter randomized controlled clinical trial is to evaluate the~     effectiveness of an alternative treatment for deep caries lesions in Public Health Services.~     The alternative treatment consists of partial removal of carious dentine followed by~     restoration. The subjects were assigned to test or control groups: test - carious dentine~     partial removal and restoration in one session, and control - stepwise excavation. The~     stepwise excavation consists of partial removal of carious tissue from the cavity floor,~     indirect pulp capping with calcium hydroxide cement; temporary filling; cavity re-opening~     after 60 days, removal of the remaining soft carious tissue and filling. Each group was~     divided according to the filling material: amalgam or resin. The radiological exams are being~     performed before and after the treatment and then annually. Clinical evaluation of the~     restorations is performed right after the treatment and then annually (modified USPHS~     System). All evaluations are performed by calibrated and trained dentists.~   "
204268|NCT00887939|"~     Background:~        -  Urticaria is a common itchy skin disorder that may occur spontaneously or on exposure to~          a physical trigger (called physical urticaria).~        -  Researchers are studying the genetic basis of a physically induced urticarial syndrome.~          Once called familial cold urticaria, this condition is now called familial cold~          autoinflammatory syndrome (FCAS). FCAS is an autoinflammatory disease, a group of~          inherited disorders characterized by unprovoked episodes of inflammation. Patients with~          FCAS often have hives, joint pain, and fever following general exposure to cold.~        -  Patients with FCAS have a mutation in a gene that makes a protein called cryopyrin.~          Cryopyrin seems to be involved with the production of a proinflammatory mediator called~          interleukin-1 (IL-1). Patients with FCAS and others with autoinflammatory syndromes have~          benefited from medication that blocks the effects of IL-1.~      Objectives:~        -  To investigate mechanisms that may cause physical hives or urticaria.~        -  To reproduce urticaria through challenge testing (procedures to test the skin for a~          reaction to a stimulus), followed by mast cell studies, measurement of IL-1, genetic~          studies, and other molecular studies to lead to a better understanding of urticaria and~          to design safe and more effective treatments.~      Eligibility:~        -  Patients between 6 months and 65 years of age with a documented history of clinically~          reproducible physical urticaria that triggers hives and that has been evaluated by a~          physician. Patients should have a letter of referral, including copies of pertinent~          medical history and laboratory studies, from a referring physician.~        -  Affected and nonaffected family members of such patients.~        -  Exclusion criteria include (1) the presence of conditions that may put the subject at~          undue risk, such as acute infection, severe thrombocytopenia (a lower than normal number~          of platelets in the blood), or significant cardiovascular disease; (2) any condition~          that would make the subject unsuitable for enrollment in this study; and (3) a history~          of HIV, other known immunodeficiency, or evidence of chronic Hepatitis B and/or C~          infection.~      Design:~        -  Researchers will conduct the following tests to verify which triggers cause the hives:~             -  History and physical exam to determine the relationship between the trigger and~               appearance of the hives.~             -  Blood samples for baseline screening (additional samples may be taken within 8~               hours of triggering hives).~             -  Verification of hives using standard challenge testing.~        -  Procedures to trigger urticaria (the challenge testing) include dermatographism~          (stroking the skin), delayed pressure urticaria (direct pressure), cold-induced~          urticaria (cold exposure), cholinergic urticaria (exercise, hot water), solar urticaria~          (sun exposure), localized heat urticaria (direct heat exposure), aquagenic urticaria~          (room temperature water), and vibratory angioedema (direct vibratory stimulus exposure).~        -  Participants who have a positive history for hives and failed challenge testing (that~          is, hives resulted from the triggers) will be asked to provide a skin biopsy and~          additional bloods samples for research purposes.~        -  Participants will be asked to return to the clinic within 1 month if multiple triggers~          could not be verified during the initial visit, or to return for additional research~          evaluations, which may include a skin punch biopsy and blood sample collection. Patients~          may have to stay at the hospital overnight, if required to document the disease.~        -  Nonaffected family members who enroll in this protocol will provide samples for~          comparison with the family member who has a history of hives.~        -  Participants will receive a small financial compensation for the skin biopsy.~   "
204269|NCT00887926|"~     The purpose of this study is to determine if IMC-EB10 is safe for patients with leukemia, and~     also to determine the best dose of IMC-EB10 to give to patients.~   "
204270|NCT00887913|"~     The purpose of this study is to determine whether the Matrix RF applicator is effective in~     the treatment of facial skin texture and wrinkle reduction.~   "
204271|NCT00887900|"~     The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK)~     using the big-bubble technique.~   "
204272|NCT00887887|"~     The purpose of the study is to test whether the presence of polymorphisms in genes encoding~     substances of the innate immune response in patients undergoing partial hepatic resection~     because of benign or malignant hepatobiliary disease is related to a higher incidence of~     infectious complications, post-resectional liver failure or mortality.~   "
204273|NCT00887874|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     current status of diabetes management, control, and complications in diabetic subjects in~     Asia.~   "
204274|NCT00887861|"~     This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in~     therapy-refractory partial seizures.~   "
204275|NCT00887848|"~     The purpose of the study is to investigate the effectiveness of robotic-assisted locomotor~     therapy on improvements of functional gait parameters in ambulatory children with cerebral~     palsy.~   "
204276|NCT00887835|"~     The purpose of this study is to utilize the PERPOS™ PLS System for transfacet lumbar spine~     fixation to evaluate its effect on patients' level of pain, procedural complications and~     functional status.~   "
204277|NCT00887822|"~     This 2 arm study will compare the efficacy and safety of bevacizumab in combination with~     capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in~     participants who have not received prior chemotherapy for advanced or metastatic gastric~     cancer. Participants will be randomized to one of two treatment groups Bevacizumab +~     Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).~   "
204278|NCT00887809|"~     The purpose of this study is to test whether an experimental drug called bevacizumab given~     together with gemcitabine and docetaxel, a standard chemotherapy regimen for sarcoma, can~     help sarcoma patients. This trial will examine what effects, good and/or bad the combination~     of gemcitabine, docetaxel and bevacizumab has on sarcoma.~   "
204283|NCT00887731|"~     Nearly forty years ago Berran and coworkers tested an analog oxygen controller to maintain~     incubator oxygen levels for infants suffering neonatal respiratory disease in order to~     prevent hyperoxia.~      There are at least three clinical issues that this technology addresses: the first is~     avoidance of episodic hyperoxia; the second is decreasing episodic hypoxia; and the third is~     lowering cumulative oxygen exposure.~      Clinical trials which have used target SpO2 ranging probably help improve all of these~     problems, but so far there have been no direct measurements of continuous arterial oxygen~     levels, nor clinical studies which establish the degree to which improving control over blood~     oxygen saturation decreases the cumulative amount of oxygen exposure. This study will address~     the later and is an important step in the process of incorporating closed-loop oxygen control~     technology as a routine standard of neonatal respiratory care.~      OBJECTIVES:~      PART 1: Test and modify the instruction set for the computerized oxygen controller to achieve~     a goal of less than six (6) operator required interruptions per hour for oxygen saturation~     deviations outside of study guidelines.~      PART 2: Perform a within patient cross-over trial of the computerized oxygen controller~     versus standard of care (the patient's care team adjusts the patient's oxygen level) and~     evaluate the area under the time curve for oxygen exposure between the two control methods.~      PART 3:(After successful completion of PART 2) Continuation of the within patient cross-over~     study with a randomized cross-over sequence. Studies will last 4 to 12 hours divided in two~     (2) equal time blocks with one cross-over to either automatic or manual control modes.~     Provision for up to an additional twenty (20) patients to be studied.~   "
204284|NCT00887718|"~     This study examines the role of a diagnostic test called Positron Emission Tomography (PET)~     scanning in patients with malignant lymphoma. The primary goal of this study is to find out~     how well PET scanning can detect malignant (cancerous) lymphoma, and how often this extra~     information will result in a change of stage of disease, or will result in a change in~     treatment management plans of patients with lymphoma.~   "
204285|NCT00887705|"~     ADL training of copd patients results in better execution of activities of daily living.~   "
204286|NCT00887692|"~     10 patients will be treated alternating daily between prone and supine position for breast~     radiotherapy to compare set-up accuracy. Prone treatment will be given on the odds days and~     supine treatment on the even days.~   "
204287|NCT00887679|"~     The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and~     effective in the treatment of HIV-infected patients with generalized anxiety disorder.~   "
204288|NCT00887666|"~     People with heart failure may have low magnesium and low vitamin D levels. They may also have~     abnormally high levels of parathyroid hormones. Magnesium and vitamin D are important~     chemicals that are not routinely measured in blood tests. We are studying how many people~     with heart failure have low levels of magnesium and vitamin D. We are also studying how many~     people with heart failure have overactive parathyroid glands and if that is related to their~     vitamin D levels.~   "
204289|NCT00887653|"~     The success of combination antiretroviral therapy heralded a revolution in the treatment of~     HIV in the mid-1990s. However, severe treatment-associated side effects have been observed~     including diabetes and increased cholesterol which are linked to premature heart attacks.~     This effect has been described among many regimens containing protease inhibitors (PIs), as~     well as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Raltegravir is a new~     medicine which has been shown to be potent and efficacious in suppression of the HIV. This~     study hopes to determine if switching from a PI or NNRTI to raltegravir will decrease~     cholesterol in subjects with high cholesterol and well controlled HIV. In addition, the study~     aims to confirm that raltegravir is safe and well tolerated. It also seeks to confirm if~     raltegravir will have similar anti-HIV activity compared with the patient's previous regimen.~      The study will last 6 months and will involve 20 subjects. HIV-1 infected men and women on~     PIs or NNRTIs for at least 12 months before study entry with well controlled HIV will be~     recruited.~      Hypotheses:~        1. Patients with elevated lipid levels while on combination antiretroviral therapy with PIs~          or NNRTIs will experience an improvement in lipid levels after switching their PI or~          NNRTI to a raltegravir based regimen.~        2. Raltegravir will be safe and well tolerated.~        3. Raltegravir will have similar antiretroviral activity compared with the prior regimen.~      Primary Objective:~      To demonstrate an improvement in lipid profile (triglycerides or LDL) in subjects switched to~     raltegravir from PIs or NNRTIs at 2, 3, and 6 months after study entry.~      Study Design: Subjects will be given the option to switch from their current regimen to~     raltegravir at 400mg twice daily. Those who consent, will receive raltegravir provided by the~     study for 6 months. At entry, the subjects will undergo a complete physical exam and~     thereafter targeted exams at each visit. Labs will be drawn as part of clinical care at 2, 3,~     and 6 months. Some of the blood will be stored for later analysis. Also, the subjects will~     answer regular surveys on drug toxicity and quality of life. Their cholesterol level will be~     compared before and after the study. At the end of the study, the participants may choose to~     continue on raltegravir if they desire.~   "
204290|NCT00887640|"~     This is a single arm study of 11 men with treatment refractory metastatic Castrate Resistant~     Prostate Cancer (CRPC) who will receive temsirolimus IV at a dose of 25 mg weekly until~     progression. Progression will not include Prostate Specific Antigen (PSA) progression;~     however, upon PSA progression, the addition of an anti-androgen will be permitted. The~     primary objective of the study is to evaluate change in circulating tumor cell (CTC) counts~     over time in men with metastatic treatment-refractory CRPC in response to temsirolimus~     therapy.~   "
204291|NCT00887627|"~     A study to compare a conivaptan PK in subjects with mild or moderate kidney function~     impairment to subjects with normal kidney function after a 48-hour continuous infusion of~     conivaptan.~   "
204292|NCT00887614|"~     The purpose of this study is to determine whether participating in a Mindfulness-Based Stress~     Reduction (MBSR) program increases mindful attention and awareness, and whether anticipated~     changes in mindfulness relate to improved emotional well-being, sleep quality, physical~     symptoms of stress, sense of spirituality, and quality of life following MBSR.~   "
204293|NCT00887601|"~     This study will evaluate functional magnetic resonance imaging (fMRI) and methods for~     measuring drug induced changes in cerebral blood flow as biomarkers for attention-improving~     drugs.~   "
204294|NCT00887588|"~     The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan~     on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart~     failure and preserved left-ventricular ejection fraction.~   "
204295|NCT00887575|"~     This trial will examine the combination of sunitinib plus paclitaxel and carboplatin as~     neoadjuvant treatment for locally advanced breast cancer.~   "
204296|NCT00887562|"~     The purpose of this study is to compare the efficacy of two (2) different doses of idebenone~     with that of a placebo over a one month period on cerebral lactate concentration as measured~     by magnetic resonance spectroscopy.~   "
204330|NCT00887120|"~     To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in ARV PI~     naive HIV-1 infected Thai children.~      To study clinical and immunological efficacy after 48 weeks of lopinavir/ritonavir in PI~     naïve HIV-1 infected Thai children~   "
204297|NCT00887549|"~     Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this~     research is to determine if there is a link between TS production and how well patients~     respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the~     future is that doctors could have a better understanding in advance about which patients~     might respond well to pemetrexed based on how much TS they produce.~   "
204298|NCT00887536|"~     The main purpose of this study is to learn if adding bevacizumab to standard treatment with~     chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative~     breast cancer will prevent breast cancer from returning. A second purpose of this study is to~     learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative~     breast cancer live longer. The researchers also want to learn about the side effects of the~     combination of drugs used in this study.~   "
204299|NCT00887523|"~     84 patients with a cup size C or more will be randomized to receive intensity-modulated~     radiotherapy in supine or prone position.~   "
204300|NCT00887510|"~     High blood pressure, also referred to as hypertension, is a blood pressure level of 140/90 mm~     Hg or higher. Along with lifestyle changes, various medications are currently used to treat~     people with hypertension. Some of these medications, however, may affect the way the body~     handles sugar, essentially preventing the body from breaking down sugar and predisposing~     people to developing diabetes. People who have metabolic syndrome—a condition primarily~     characterized by an increased waist measurement, abnormal blood lipid levels, hypertension,~     and high blood sugar levels—are already at risk of developing diabetes. In these people,~     taking the antihypertensive medications that prevent sugar breakdown may further increase~     their risk of diabetes. The purpose of this study is to gain an understanding of how people~     with metabolic syndrome respond to antihypertensive medications that alter the body's ability~     to break down sugar.~   "
204301|NCT00887497|"~     One of the major complications of surgical excision of colorectal cancer includes improper~     healing of the anastomosis (reconnection of the remaining, cancer free intestine). This can~     result in anastomotic leak, abscess then abdominal and/or pelvic sepsis and mortality.~      Esophageal surgery has suffered from complications. Recently, an innovation in esophageal~     surgery has seen a relatively drastic decrease in complications during distal esophagectomies~     using a technique called ischemic conditioning. This technique involves dividing the blood~     supply to the stomach that would be performed during a 1-stage esophagectomy but returning~     days later to complete the resection. Bench results have shown improved angiogenesis,~     vasodilation, less anastomotic collagen deposition and minimized ischemia at the time of~     surgery while clinical results have included improved stricture rates, leak rates and~     mortality in esophageal surgery.~      Hypothesis Ischemic conditioning is universal to the intestinal tract and a similar technique~     can be applied in colon and rectal surgery. The investigators plan evaluating this hypothesis~     by performing a pilot study comprised of the following: performing an endovascular~     embolization of the inferior mesenteric artery (IMA) followed by interval laparoscopic or~     open rectosigmoid resection.~      Methods Part 1 - Endovascular Procedure Patients will be admitted and undergo endovascular~     embolization of their IMA as an outpatient following diagnostic angiography. They will~     undergo sigmoidoscopy throughout the embolization and a laser probe will indirectly measure~     tissue oxygenation. The patient will be released home that day.~      Part 2 - Colorectal Procedure Patients will then return 2-4 days later for their definitive~     laparoscopic or open rectosigmoid resection. They will undergo sigmoidoscopy before and after~     surgery and a laser probe will indirectly measure tissue oxygenation. The patient will then~     be released home on average 3-5 days later.~   "
204302|NCT00887484|"~     The purpose of this study is to compare the tolerability of topical combination therapies in~     the treatment of facial acne.~   "
204303|NCT00887471|"~     The purpose of this study is to demonstrate similar improvements in sleep-disordered~     breathing as determined by sleep study with microdebrider-assisted partial intracapsular~     tonsillectomy and adenoidectomy versus total Bovie electrocautery tonsillectomy and~     adenoidectomy.~   "
204304|NCT00887458|"~     This research is being done to test an investigational drug, called itraconazole, in the~     treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration~     (FDA) for the treatment of various fungal infections such as fingernail/toenail infections~     and other more serious fungal infections. The word investigational means that itraconazole~     is not approved for use in people with cancer. However, the FDA is allowing the use of~     itraconazole in this research study. Itraconazole has been shown to have activity against~     cancer (including prostate cancer) in the laboratory, but has not been tested against cancer~     in humans.~      The purpose of this study is to find out:~        -  If itraconazole is safe when given at two different doses~        -  How itraconazole affects prostate specific antigen (PSA): a blood test that measures~          substances released by prostate cancer~        -  Whether itraconazole can delay further prostate cancer growth and spread~        -  How itraconazole affects other markers of prostate cancer~   "
204305|NCT00887445|"~     First in man study with single and multiple rising doses with SLV341~   "
204306|NCT00887432|"~     This randomized clinical trial studies how well cholecalciferol supplement works in treating~     patients with localized prostate cancer undergoing observation. Cholecalciferol may help~     prostate cancer cells become more like normal cells, and to grow and spread more slowly.~   "
204307|NCT00887419|"~     This study is for patients who have been approved by their doctors and insurance companies to~     receive spinal cord stimulator implants.~      The goal of this study is to investigate if pain and disability is improved in patients with~     an implant in combination with coping skills training. These patients are compared with those~     with an implant that receive chronic education information and those with an implant that are~     in the control group and receive no additional training or information.~   "
204308|NCT00887406|"~     GSK961081 is a new long-acting bronchodilator being developed for the treatment of chronic~     obstructive pulmonary disease (COPD). This study is the first clinical study in humans. The~     purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of GSK961081 in healthy male subjects.~   "
204331|NCT00887107|"~     The purpose of this study is to assess whether therapy with Sorafenib reinduces radioiodine~     uptake in thyroid carcinoma.~   "
204332|NCT00887094|"~     Many studies were already performed showing beneficial cardiovascular and metabolic effects~     of physical training for type 2 diabetic patients. However, glucose profile during and~     immediately after a short period of aerobic and/or resistance training was not studied yet.~     Continuous glucose monitoring system (CGMS) has now been added to the repertoire of~     technological devices useful in the management of patients with diabetes. Such monitoring~     enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable~     with intermittent testing of blood glucose. The main aim of the present study is to~     investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and~     ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2~     diabetic patients.~   "
204309|NCT00887393|"~     Nonalcoholic Liver disease (NAFLD) is known to be caused by deposition of fat in the liver.~     The impact of NAFLD on bariatric surgery is of great concern. Enlarged fatty livers increase~     the operative complications of bariatric surgery and weight loss prior to bariatric surgery~     has been shown to reduce complications of surgery. Most bariatric surgery programs use a~     conventional low fat, calorie restricted diet during the preparation phase for surgery. The~     investigators will compare the effects of the low carbohydrate versus the low fat diets on~     weight loss, reduction in liver fat content, and liver size. These results will provide new~     clinical insights into the optimal dietary intervention to make bariatric surgery safe and~     effective for the increasing numbers of patients opting for this aggressive therapy for~     morbid obesity. Patients approved for bariatric surgery by the University of Michigan~     Bariatric Surgery multidisciplinary committee will be randomly assigned to either a 1000 to~     1200 calorie low fat or low carbohydrate, 8-week study diet. All the food for this study will~     be provided for free by the study team. Participants will be required to meet with the study~     team weekly to pick up study food and for a nutritional consult. These visits will occur in~     the eight weeks preceding the patient's bariatric surgery procedure. During the bariatric~     surgery, a liver biopsy will be performed to assess the impact of the study diet on liver fat~     content.~   "
204310|NCT00887380|"~     The purpose of this study is to determine whether starting anastrozole prior to radiotherapy,~     so that it is taken during radiotherapy, decreases local recurrence of breast cancer in~     post-menopausal women in comparison to waiting until after radiotherapy to commence~     anastrozole.~   "
204311|NCT00887367|"~     This study will investigate the possible effects of alcohol in combination with GSK598809 on~     the central nervous system in 20 healthy male and female volunteers, between 18 and 65 years~     of age.~      During 4 separate study periods subjects will receive the following treatment combinations:~     Alcohol + GSK598809, alcohol + placebo drug, placebo infusion + GSK598809, and placebo~     infusion + placebo drug. A placebo is a pill or liquid infusion which contains no drug or~     alcohol; it is a dummy version. Therefore it is administered in the same way that either the~     study drug or ethanol is depending on which placebo it is. All study drugs are administered~     in a random order and both the doctor and the participant are not aware of the treatment~     combination. However treatment combinations will be available at the end of the study or in~     case of an emergency. GSK598809 is administered orally and alcohol is administered per~     infusion. The duration of the infusion is 5 hours, during which approximately 75 grams of~     alcohol is infused, which is comparable to less than one bottle of wine.~   "
204312|NCT00887354|"~     This study will evaluate whether teriparatide is superior to the active comparator in the~     change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal~     women with low bone mass and a recent pertrochanteric hip fracture.~   "
204313|NCT00887341|"~     This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using~     2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have~     shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or~     anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv~     every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion~     time for the first administration, followed by a 31 minute infusion time for subsequent~     administrations (unless drug-related infusion reactions occur).The anticipated time on study~     treatment is 3-12 months, and the target sample size is <100 individuals.~   "
204314|NCT00887328|"~     The primary hypothesis being tested in this trial is that ischaemic stroke patients selected~     with significant penumbral mismatch (measured by MRI criteria) at 3 - 9 hours post onset of~     stroke will have improved clinical outcomes when given intravenous tissue plasminogen~     activator (tPA) compared to placebo.~   "
204315|NCT00887315|"~     Primary goal of the study is to assess the overall survival of the addition of~     hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin.~     Survival will be assessed at 1 year from the date of study enrollment to date of death.~   "
204316|NCT00887302|"~     This study is an investigation of the metabolics of RYGB with gastrostomy.~   "
204317|NCT00887289|"~     The main goal of this open-label, prospective, non-controlled, non-interventional post~     marketing surveillance study is to evaluate how pramipexole treatment works when applied in~     actual practice. In actual practice patients who would have been excluded in the clinical~     registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome~     (i.e. those with certain disease histories, co-morbidities and/or demographic~     characteristics) will also be treated with pramipexole. Thus, during this post marketing~     surveillance study additional information on the efficacy and safety of pramipexole in those~     patients will be obtained. The objectives of this post marketing surveillance study are:~        -  To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory~          symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain~          Questionnaire.~        -  To assess if improvement of sensory symptoms correlates with overall Restless Legs~          Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with~          secondary symptoms like sleeping problems and daytime tiredness (items 1 & 6 from~          Restless Legs Syndrome-6).~        -  To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity~          (International Restless Legs Syndrome Scale for Severity) differs between patients with~          high pain scores and patients with lower pain scores.~        -  To compare General Practitioner and neurologist sites patient populations in terms of~          demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit~          3.~        -  To evaluate the development of behavioural changes under pramipexole treatment.~   "
204318|NCT00887276|"~     The purpose of this study is to prove the clinical and bacteriological non-inferiority of~     ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe~     community-acquired pneumonia.~   "
204319|NCT00887263|"~     The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg~     effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with~     resistant oral cGvHD.~   "
204320|NCT00887250|"~     After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms,~     after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks.~     This study evaluated if losartan is more effective than placebo in lowering sitting diastolic~     blood pressure and is well tolerated in patients with mild to moderate hypertension.~   "
204321|NCT00887237|"~     Despite technological progresses the rate of non-responders to cardiac resynchronization~     therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to~     incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during~     CRT.~      One might hypothesize that stimulating the ventricles at a single site is suboptimal and that~     stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve~     ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First~     studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly~     dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling~     and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV~     pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of~     the cardiac dyssynchrony.~      The present pilot trial was designed to examine the 6-month safety of biventricular~     stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective-~     and to assess its clinical benefit.~   "
204322|NCT00887224|"~     The primary purpose of this study is to compare the long-term efficacy and safety of~     desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive~     Disorder, using a randomized withdrawal design. Randomized withdrawal means that after~     receiving desvenlafaxine succinate sustained release for a predetermined period of time,~     subjects will be selected by chance to either continue receiving the study drug or to be~     withdrawn from the study drug and receive placebo for the remainder of their participation in~     the trial. Subjects will not know to which group they have been assigned.~      The study consists of an up to 14-day screening period followed by an 8-week open-label~     period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate~     sustained release. Subjects who do not respond to treatment, demonstrating no significant~     change in their depressive symptoms, will be withdrawn from participation at the end of this~     period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine~     succinate sustained release at the same dose. Subjects with stable response to treatment at~     the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate~     sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or~     until symptoms of depression return. Following discontinuation at any point after enrollment~     in the study, subjects will receive two weeks of follow-up monitoring, including one week of~     blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any~     subjects who have been taking desvenlafaxine succinate sustained release prior to~     discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following~     taper, subjects will be evaluated for one additional week to monitor safety.~   "
204323|NCT00887211|"~     A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting~     stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to~     evaluate the safety and efficacy of ProStent drug-eluting stent in treating coronary artery~     lesions.~   "
204324|NCT00887198|"~     This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus~     prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with~     metastatic castration-resistant prostate cancer (CRPC).~   "
204325|NCT00887185|"~     Designed to test the efficacy of a computer based virtual simulation for teaching ear~     surgery.~   "
204326|NCT00887172|"~     Upper respiratory tract infections (URTIs) are the most common illnesses in primary medical~     services but there is no established cure for these conditions in Western medicine. In Hong~     Kong, many patients use Chinese herbal medicine (CHM) for the treatment of URTIs but there is~     little research evidence on their effectiveness or side effects. The aim of this study is to~     test whether two commonly used Chinese herbal medicine (CHM) formulae guided by Traditional~     Chinese medicine (TCM) diagnosis will significantly increase recovery rate, and reduce the~     duration and/or severity of symptoms, and improve the quality of life of patients with URTIs~     in primary care.~      If a patient consents to take part in the study and is found eligible, he/she will be invited~     by the consulting doctor, and then be assessed by a registered Chinese medicine practitioner~     for whether the illness satisfies the TCM diagnosis of the two major TCM types of URTIs:~     Group A (Wind-cold syndrome) and Group B (Wind-heat syndrome). Subjects in Group A (Wind-cold~     syndrome) will be randomised to receive the Jing Fan Bai Du san or placebo. Subjects in Group~     B (Wind-heat syndrome) will be randomised to receive Ying Qiao san or placebo. Both group A~     and B treatments and placebo will be given in sachets of granules that are identical in~     appearance. Neither the Chinese medicine practitioner, the recruiting doctors, nor patient~     know whether a subject is taking CHM or placebo.~      328 subjects (164 in each diagnosis group) will be recruited from patients consulting the Ap~     Lei Chau Government General Outpatient clinic for URTIs. Each subject is required to return~     to the clinic for follow-up assessment by the Chinese medicine practitioner on day 7~     post-treatment and all subjects will be contacted by telephone on Day 2, 3, 5, 9, 11, 13,15~     and 20 after treatment to assess their symptoms and to find out if they have developed any~     side effects or adverse reactions.~      The main outcome measure is any difference in the proportion of subjects who have resolution~     of the URTI on Day 7 between the treatment and placebo groups. The secondary outcome measures~     are the reduction in the duration and severity of symptoms, quality of life during the~     illness and side effects.~      This study will provide scientific evidence to support or refute the effectiveness of two~     commonly used CHM formulae in the treatment of URTIs.~   "
204327|NCT00887159|"~     This randomized phase II trial studies cisplatin and etoposide to see how well they work when~     given with or without Hedgehog inhibitor GDC-0449 (vismodegib) or IGF-1R MOAB IMC-A12~     (cixutumumab) in treating patients with extensive-stage small cell lung cancer. Drugs used in~     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Etoposide may slow the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Vismodegib may slow the growth of tumor cells. Monoclonal antibodies,~     such as cixutumumab, may interfere with the ability of tumor cells to grow and spread. It is~     not yet known whether giving cisplatin and etoposide are more effective when given together~     with vismodegib or cixutumumab in treating small cell lung cancer.~   "
204328|NCT00887146|"~     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,~     such as temozolomide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. It is not yet known whether giving~     radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is~     more effective in treating anaplastic glioma or low grade glioma.~   "
204329|NCT00887133|"~     Background:~      Primary care plays an important role in health care delivery, but there is little research on~     its effectiveness. Western medicine is the most widely used and Traditional Chinese medicine~     (TCM) is gaining popularity. The investigators recent study showed that TCM consultations at~     the TWH were effective in improving the quality of life of patients in primary care. The aim~     of the present study is to evaluate the effectiveness of Western Medicine (WM) in primary~     care for comparison with the effectiveness of TCM consultations, so that policy makers and~     the public can be better informed.~      Objectives:~      To evaluate whether WM consultation can significantly improve the quality of life of patients~     in primary care and to find out whether there is any difference in the effectiveness of WM~     and TCM, overall and for different health problems.~      Design, Setting & Subjects:~      A prospective study on 700 patients recruited from the TWH and the Ap Lei Chau primary care~     outpatient clinics (OPC) in Hong Kong.~      Methods:~      All patients consulting for a new episode of illness at the study OPC will be recruited if~     they meet the selection criteria and consent to participate. Each patient will be asked to~     complete a structured questionnaire on socio-demography, morbidity and service utilization,~     the Hong Kong version of the Chinese Quality of Life instrument (ChQOL-HK), the Chinese (Hong~     Kong) SF-36 (SF-36-HK) and the PEI-2 before the consultation. Each subject will be followed~     up two weeks later either at the clinic or by telephone to complete the ChQOL-HK and the~     SF-36-HK again together with the Patient Enablement Instrument (PEI), the Global Rating Scale~     (GRS) on change of the condition, and a questionnaire on service utilization~      Outcome Measures and Data Analysis:~      The primary outcome measures are the changes in ChQOL-HK and SF-36-HK scores after the~     consultation. The GRS and PEI scores will be secondary outcomes. The ChQOL -HK and SF-36-HK~     scores will be correlated with the the GRS and PEI. Multivariate regressions will be carried~     out to identify factors that are associated with effectiveness. The outcomes will be compared~     with those obtained from the previous study on the TCM primary care clinics.~      Results:~      This is the first study in Hong Kong to evaluate the effectiveness of WM in primary care with~     a validated generic outcome measure, HRQOL. It will provide information on the benefit and~     limitations of WM, and allow a direct comparison between WM and TCM.~   "
204333|NCT00887081|"~     Worldwide, several studies report that 4.4% to 85.4% of thalassemia patients were positive~     for anti hepatitis C antibodies. Recently, three different studies reported the efficacy and~     the safety of combination therapy with pegylated interferon and ribavirin in thalassemic~     patients. This study is carried ahead to assess the impact of combination therapy with~     pegylated-interferon and ribavirin in a large cohort of italian patients with beta~     thalassemia major - transfused and not transfused, sickle cell disease and~     sickle/beta-thalassemia.~   "
204334|NCT00887068|"~     The goal of this clinical research study is to learn if Vidaza (azacitidine) will help to~     control the disease in patients with AML, CMML, or MDS after an allogeneic (donor) stem cell~     transplant. The safety of this drug will also be studied.~   "
204335|NCT00887055|"~     The purpose of this study is to characterize the morphology (shape) of the intracardiac~     electrograms(EGM) from patients with a resynchronization therapy device.~   "
204336|NCT00887042|"~     Cord blood transplantation (CBT) is an alternative option for patients with pediatric acute~     leukemia that indicated stem cell transplantation. Although CBT is as affective as unrelated~     bone marrow transplantation with lower graft versus host disease (GVHD) severity and~     incidence, transplantation related mortality (TRM) has been major problems after~     myeloablative conditioning. To reduce TRM, CBT with non-myeloablative conditionings have been~     performed but not so satisfactory especially for engraftment rate. Recently reduced toxicity~     myeloablative conditioning regimen was developed with promising result in adult bone marrow~     or mobilized peripheral blood transplantation. To increase the engraftment potential with low~     TRM rate, reduced toxicity myeloablative conditioning composed of fludarabine, intravenous~     busulfan plus thymoglobulin is planned for pediatric patients with acute myeloid leukemia.~   "
204337|NCT00887029|"~     Hypothesis:~        -  H1: Efficacy of Duotrav will be superior to Xalacom at 24 hours post dosing when both~          medications are given in the morning~        -  H2: A significant proportion of patients will prefer dosing of once daily topical fixed~          combination therapy in the morning compared to evening dosing~   "
204338|NCT00887003|"~     The purpose of this study is to examine 4 different epidural dosing regimes of local~     anaesthetic solution in a series of 3 epidural injections over a period of 12 months to~     determine the optimum dose of anaesthetic solution for pain relief and to determine the~     nature of any adverse events by measuring anxiety and depression, functionality and any side~     effects of the medication.~   "
204339|NCT00886990|"~     The virological efficacy will be no different in children treated with single versus double~     boosted PI second line ART regimens.~   "
204340|NCT00886977|"~     The efficacy and safety are evaluated when YAM80 is administered orally to the patients of~     Amyotrophic Lateral Sclerosis (ALS).~   "
204341|NCT00886964|"~     The purpose of this study is :~        -  To evaluate prevalence of protective hepatitis B antibody comparing intradermal (ID) and~          intramuscular (IM) route in antiHbsAb negative HIV infected children treated with highly~          active antiretroviral therapy (HAART)~        -  To revaccinate the HBV vaccine in the children who didn't have protective HBV Ab~   "
204342|NCT00886951|"~     The main objectives of this proposal are as follows:~        -  To assess the dynamic uptake and washout of 123-I MNI-388 and MNI 390, a potential~          imaging biomarker for β-amyloid burden in brain, using single photon emission computed~          tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls~        -  To perform blood metabolite characterization of 123-I MNI-388 and MNI-390 in healthy and~          AD subjects to determine the metabolic fate and nature of metabolites in assessment of~          123-I MNI-388 and MNI 390 as a single photon computed tomography (SPECT) brain imaging~          agent~   "
204343|NCT00886938|"~     The neurological basis of tinnitus is uncertain when there is no evidence of damage to the~     peripheral auditory system. However, neuroimaging studies of tinnitus patients show~     hyperactivity in several cortical regions, especially the auditory cortices and middle~     temporal regions. A potentially promising treatment modality for tinnitus is repetitive~     transcranial magnetic stimulation (rTMS). rTMS involves the application of frequent, repeated~     magnetic stimuli to the skull to induce electrical activity in the underlying cortical areas~     of the brain. When the magnetic device is placed on the skull, the resultant magnetic field~     passes through the skull and induces a small secondary current in the cortex. It has been~     hypothesized that the effect of the frequency used in rTMS differentially influences cortical~     activity with low-frequency (1Hz) stimulation decreasing and high-frequency stimulation~     (10-20 Hz) increasing cortical activity.~      Currently, reports on treating tinnitus with rTMS have focused on low-frequency stimulation~     of the left auditory cortex, an area that has been demonstrated to be hyperactive in~     tinnitus. The benefits of low-frequency auditory cortex stimulation are time limited however.~     Converging data implicate structures of the brain that are important for mood and attention~     as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment~     approach that targets these structures. A growing number of studies demonstrate involvement~     of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in~     the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal~     cortex has been shown to increase the durability of the TPC stimulation. The independent~     effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that~     increasing the intensity and duration of stimulation has beneficial treatment effects.~     However, the field is new and more work is needed to assess the effectiveness of this~     treatment, predictors and correlates of response, and safety.~      Herein, we propose an open-label pilot study investigating the effectiveness of rTMS~     stimulation of the dorsolateral prefrontal cortex, an area known to be important for mood and~     attention, in the treatment of tinnitus~   "
204344|NCT00886925|"~     The purpose of this study is to determine whether the administration of albumin in addition~     to the standard care is effective in the treatment of an episode of hepatic encephalopathy in~     patients with cirrhosis.~   "
204345|NCT00886912|"~     Some studies suggest that high-altitude related illnesses - like acute mountain sickness -~     could be prevented by acclimatisation, reached at low altitude using training in simulated~     altitude. The purpose of this study is to determine whether training in hypoxia is suitable~     to prevent acute mountain sickness.~   "
204346|NCT00886899|"~     Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total~     occlusions (CTOs). Published results of safety and effectiveness of conventional techniques~     will be used for comparison. Enrollment of up to 149 subjects with a CTO refractory to~     currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US~     clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in~     treating coronary CTOs compared to CTO literature.~   "
204375|NCT00886522|"~     The purpose of this study is to evaluate the engraftment of donor hemopoiesis (proportion of~     transplanted patients with successful engraftment at day +42) in adult patients affected by~     high risk hematological malignancies after intrabone infusion of cord blood.~   "
204376|NCT00886509|"~     The purpose of this study in patients with stable coronary artery disease (CAD) treatable by~     PCI (percutaneous coronary intervention) is to evaluate the long-term efficacy and safety of~     subcutaneously applied, pegylated granulocyte colony stimulating factor (Pegfilgrastim,~     PEG-G-CSF; Neulasta®, Amgen Switzerland) with regard to the promotion of collateral growth.~   "
204347|NCT00886886|"~     MDMA releases dopamine, serotonin, and norepinephrine in the brain. Serotonin uptake~     inhibitors have been shown to interact with 3,4-Methylenedioxymethamphetamine (MDMA) and to~     decrease its psychoactive and cardiovascular stimulant effects. This finding indicates that~     MDMA acts in part by releasing serotonin through the serotonin uptake site. However, in vitro~     studies show that MDMA binds more potently to the norepinephrine uptake site that to the the~     serotonin or dopamine uptake transporter. In addition, norepinephrine uptake site blockers~     such antidepressant drugs attenuate some of the behavioral effects of MDMA in animals. These~     preclinical data indicate that norepinephrine may also contribute to the response to MDMA in~     humans. To test this hypothesis this study evaluates the interacting effects of the selective~     norepinephrine transporter inhibitor reboxetine on the subjective and cardiovascular~     stimulant effects of MDMA in healthy volunteers.~   "
204348|NCT00886873|"~     The objectives of this study are to estimate the efficacy and safety of the daily~     administration for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried~     out to estimate how the effects of mifepristone are kept in time.~      The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma~     up to 50% in six months treatment.~   "
204349|NCT00886860|"~     The purpose of this study is to compare the efficacy for cervical ripening in labor induction~     between titrated and conventional oral misoprostol~   "
204350|NCT00886847|"~     Primary objective:~        -  To estimate the degree of agreement in diagnosis of cytologic samples from mediastinal~          lymph nodes obtained by Endobronchial Ultrasound (EBUS)-guided Fine Needle Capillary~          Sampling (FNC) versus Fine Needle Aspiration (FNA).~      Secondary objective:~        -  To compare the quality of cytologic samples from mediastinal lymph nodes obtained by~          EBUS-guided FNC versus FNA. The quality of the samples will be assessed initially by~          MDACC on-site cytology technicians, and then corroborated by physicians in the~          department of cytology. This assessment will be performed utilizing the Mair's score 3.~          The score consists of a 0-10 scale: 1-2= poor; 3-6=good; 7-10=superior.~   "
204351|NCT00886834|"~     The purpose of this study is to see if inserting misoprostol in the vagina or between your~     cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a~     baby makes it easier and less painful.~   "
204352|NCT00886821|"~     The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2~     diabetic patients.~   "
204353|NCT00886808|"~     The goal of the study is to evaluate the safety and tolerability of 4 different doses of~     iCo-007 Intravitreal Injection in patients with diffuse diabetic macular edema.~   "
204354|NCT00886795|"~     This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and~     effective in treating people with chronic urticaria (persistent hives).~   "
204355|NCT00886782|"~     The purpose of this study is to determine safety, tolerability and maximum tolerated dose of~     BMS-863233 in subjects advanced and/or Metastatic solid tumors.~   "
204356|NCT00886769|"~     This study assessed the initial efficacy and safety of canakinumab over a 4 week period in~     patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to~     treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30~     criteria at Day 15.~   "
204357|NCT00886756|"~     This is a Phase I, double-blind, placebo-controlled, randomised within each dose group,~     single ascending dose study, with the objective to assess the safety, tolerability and~     pharmacokinetic profile of AZD8529 in healthy Japanese subjects.~   "
204358|NCT00886743|"~     This is an open-label study in which oprelvekin will be administered for the prevention of~     severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting~     stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side~     effect of blocking your bone marrow from making platelet cells. The purpose of this study is~     to learn more about the effects of the recommended dose of oprelvekin on the heart's~     electrical cycle.~   "
204359|NCT00886730|"~     The purpose of this study is to develop and pilot test two interventions that lead to at~     least 30% of individuals with depression presenting to primary care engaging with an~     Internet-based depression support group. The investigators will identify primary care~     patients with depression who state they have access to the Internet and are willing to~     consider treatment for depression. In the primary care office they will be given one of three~     interventions introducing them to the Internet depression support group site. The major~     outcome will be accessing the depression Internet support group at least once in the~     following four weeks.~      The results of this study will provide important information on whether it is possible to~     recruit a substantial proportion of primary care patients to engage in a potentially useful~     and inexpensive addition to standard depression care. If this is not possible, the likelihood~     of successfully completing a RCT of the effectiveness of depression Internet support groups~     utilizing primary care patients would be low. Researchers trying to assess the effectiveness~     of depression Internet support groups would have to go to alternative designs such as~     recruiting patients with depression as they try to join the depression Internet support~     groups and randomizing some to a delay in joining the group.~   "
204360|NCT00886717|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of~     paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as~     first-line therapy in treating patients with advanced ovarian cancer.~   "
204361|NCT00886704|"~     An increase in intake of omega-3 fatty acids should increase the Omega-3 Index. Current~     evidence indicates that this may lead to a reduction in risk for sudden cardiac death and~     atherosclerotic diseases like myocardial infarction. The aim of the study is to investigate,~     how supplementing a convenience drink with omega-3 fatty acids influences the Omega-3 Index,~     as compared to an unsupplemented matching convenience drink. Palatability and safety of the~     drink are also to be assessed.~   "
204391|NCT00886314|"~     The purpose of the present investigation will be to determine whether a combination of clown~     doctor and parental presence is more effective than a combination of sedative premedication~     and parental presence for reducing anxiety in children and their parents and for improving~     parental satisfaction.~   "
204362|NCT00886691|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and~     everolimus may also stop the growth of tumor cells by blocking blood flow to the tumor. It is~     not yet known whether bevacizumab is more effective when given together with or without~     everolimus in treating ovarian epithelial cancer, fallopian tube cancer, or primary~     peritoneal cancer.~      PURPOSE: This randomized phase II trial is studying bevacizumab to see how well it works when~     given with or without everolimus in treating patients with recurrent or persistent ovarian~     epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.~   "
204363|NCT00886678|"~     Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy~     66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500~     mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).~   "
204364|NCT00886665|"~     In order to provide a alternative treatment for relieving the pain and numbness of Diabetes~     Mellitus patients,Traditional Chinese Medicine powder was tested by subjective questionnaire~     and objective nerve conduction velocity study. Liver and kidney functions were tested to~     provided safety profiles.~   "
204365|NCT00886652|"~     Adolescent Idiopathic Scoliosis (AIS) can change the respiratory dynamics and performance of~     the inspiratory and expiratory muscles, affecting ventilatory capacity. This was a~     randomized, controlled, open study to test the impact of a physiotherapeutic program of~     aerobic exercises on respiratory muscle strength, in patients with adolescent idiopathic~     scoliosis. Patients with AIS were randomly assigned to the aerobic exercise-training program~     group or the no treatment group. There was a significant increase in Pimax and Pemax in the~     group which received physiotherapy.~   "
204366|NCT00886639|"~     The aim of this study is to investigate the six-minute-walking-distance of COPD-patients with~     breathing oxygen in comparison to breathing normal air. Patients, who increase their~     walking-distance about more than 15% or 35m only because of breathing oxygen, are so-called~     Oxygen Responders. The study is aimed to find attributes of Oxygen Responder and to~     investigate, if a patient can change the respond with higher performance and endurance.~   "
204367|NCT00886626|"~     The prevalence of severely obese children is on the rise. Behavioral therapies for weight~     loss are successful in some, but others need more aggressive approaches such as drug therapy.~     In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT),~     which places them at significantly elevated risk of developing type 2 diabetes mellitus and~     cardiovascular disease. Although various drug therapies for weight loss and IGT have been~     explored in adults, few have been evaluated in children.~      Recently, a new drug class has emerged that targets deficiencies of GLP-1. One of the main~     glycemic mechanisms of action of the GLP-1 agonists such as exenatide is to enhance glucose~     disposal in the postprandial setting and improve glucose tolerance. In addition, exenatide~     can induce weight loss by decreasing appetite and slowing gastric motility.~   "
204368|NCT00886613|"~     A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers~     of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat~     treated VZV vaccine V212 or with Zostavax™.~      The enrollment of participants into this study was conducted in 2 parts, Part A and Part B.~     The first 42 eligible participants were enrolled into Part A of the study. In Part A, the~     reaction of the VZV skin test at baseline was evaluated at both 48 and 72 hours post~     administration of the VZV skin test reagent and saline (in opposite arms), with 2 examiners~     performing the reading at each timepoint; all subsequent skin test readings in Part A were~     performed at 48 hours post administration. After all skin test reactions were obtained at~     baseline for the 42 subjects in Part A, an interim analysis was performed (1) to assess the~     frequency of baseline negative skin tests in order to confirm that the planned sample size~     (N=120) was adequate for an evaluation of the effect of vaccination on the VZV Skin Test, and~     (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours~     (post administration) in order to determine the preferred time for evaluation of the skin~     test reaction.~      The interim analysis from Part A confirmed the study sample size, an additional 78 subjects~     were enrolled into Part B to achieve the planned sample size (N=120). The study procedures~     for Part B of the study were identical to those in Part A with the following exceptions: (1)~     baseline skin test readings were performed only once, at either 48 or 72 hours (post~     administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was~     needed for the skin test reading at baseline.~   "
204369|NCT00886600|"~     The purpose of this study was to evaluate the magnitude and durations of the antihypertensive~     effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the~     safety of losartan 50 and 100 mg doses compared to placebo.~   "
204370|NCT00886587|"~     The purpose of this study was to evaluate the safety of the investigational study product and~     see how well it works to relieve signs and symptoms of children with mild to moderate Atopic~     Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product.~     This study was conducted to assess the safety of the investigational new study product and~     how well it works to treat AD in children, by making AD visually better, and reducing the~     amount of itch.~   "
204371|NCT00886574|"~     This multi-center, randomized controlled study aims to evaluate the efficacy of Cilostazol~     versus Aspirin for primary prevention of atherosclerotic events with Korean type 2 Diabetes~     Mellitus (DM) patients.~   "
204372|NCT00886561|"~     This pilot study will test the efficacy of a behavioral intervention in reducing HIV related~     risk behaviors among sex workers in Yerevan, Armenia.~   "
204373|NCT00886548|"~     The purpose of this study is:~        -  To study the clinical usefulness of nurse-performed ultrasound and echocardiographic~          examinations in a cardiac intensive care unit.~        -  To study reproducibility of nurse-performed ultrasound and echocardiographic~          examinations in a cardiac intensive care unit.~        -  To study which ultrasound measure that best correlate with the amount of pleural~          effusion.~   "
204374|NCT00886535|"~     This study will be an open-label prospective observational trial designed to test~     associations between polymorphisms of candidate genes and tamoxifen. Pre- and post-menopausal~     women taking tamoxifen as standard therapy or chemopreventive therapy will be included in~     this study.~   "
204377|NCT00886496|"~     RATIONALE: Recombinant human mannose-binding lectin (MBL) may be effective in preventing~     infection in young patients with fever and neutropenia receiving chemotherapy for blood~     disease or cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of recombinant human~     mannose-binding lectin in treating young patients with MBL deficiency and fever and~     neutropenia.~   "
204378|NCT00886483|"~     Neurofeedback is increasingly advocated for treatment of ADHD despite a thin evidence base.~     The numerous open and partially controlled studies suffer serious design flaws. In~     particular, there is no published double-blind randomized clinical trial (RCT), which would~     control for experimenter and participant biases. The primary aim of this R34 pilot study is~     to conduct a small-scale pilot with 39 8-12 year-olds with ADHD to prepare for such a larger~     RCT.~   "
204379|NCT00886470|"~     The objective of this protocol is to perform a safety and dose-determination efficacy~     clinical trial in patients having a degree of partial-thickness burn wounds. The trial will~     be a prospectively randomized and double-blind trial of Amnion-derived Cellular Cytokine~     Solution (ACCS) compared with standardized care using 0.9% NaCl (normal saline) solution in~     the same three treatment regimens.~   "
204380|NCT00886457|"~     The purpose of this study is to assess toxicities of a 1-hr infusion of~     5-aza-2'-deoxycytidine (decitabine) x 10 days (M-F) plus escalating doses of weekly~     subcutaneous PEG-interferon-α (PEG-Intron) in patients with metastatic cancer and to identify~     the maximum tolerated dose of PEG-Intron in this combination. The pre- and post-treatment~     samples will be evaluated to identify changes in molecular correlates.~   "
204381|NCT00886444|"~     The aim of this study is to:~        -  clarify whether macrophage imaging using ferucarbotran is able to delineate the region~          of myocardial infarction as accurate as gadolinium-based necrosis/fibrosis imaging;~        -  identify possible differences in infarct imaging using ferucarbotran for macrophage~          imaging compared to necrosis/fibrosis imaging with gadolinium-based compounds; and~        -  evaluate which MRI pulse-sequences maximise sensitivity for macrophage imaging with~          ferucarbotran in the setting of acute myocardial infarction.~   "
204382|NCT00886431|"~     Human embryos can be preserved for later transfers by freezing. Traditionally the slow~     cooling method has been used. About 70% of the embryos remain fully intact after thawing.~     However, the remaining 30% of the embryos become (partially) damaged, and this freezing~     damage reduces their chance to implant. Recently an ultra rapid freezing method, called~     vitrification has been developed. During vitrification no damaging ice crystals are formed~     and the embryo freezes in a glass like state.~      It appears that the freezing damage is reduced when embryos are vitrified. Observational~     studies in humans indicate that embryos are successfully preserved by vitrification, as~     indicated by promising pregnancy rates following thawing. However, the effectiveness of~     vitrification in relation to slow cooling with respect to pregnancy rates has so far not been~     evaluated by a randomised, controlled trial. The aim of this study is to investigate whether~     vitrification significantly improves embryo survival and ongoing pregnancy rates when~     compared to embryos frozen by slow cooling.~   "
204383|NCT00886418|"~     Total intra-venous anesthesia can be provided using a closed-loop system guided by the~     bispectral index. The purpose of this study is to determine if myorelaxation modifies its~     functioning.~   "
204384|NCT00886405|"~     Nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and~     concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen~     pressure in tumoral tissue. The combination treatment of nitroglycerin and chemotherapy will~     result in longer disease-free and over-all survival in patients with locally advanced NSCLC~   "
204385|NCT00886392|"~     The purpose of this study is to identify the severity level distribution at the moment of~     diagnosis, in diabetic patients with macular edema from a Mexico City sample, and to identify~     the rate with severe macular edema that needed immediate treatment.~   "
204386|NCT00886379|"~     This intervention study will address the impact of vitamin D fortified milk and vitamin D~     supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone,~     academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for~     eczema) of Mongolian children.~   "
204387|NCT00886366|"~     The purpose of this study is to assess safety and tolerability of AZD6714 after single~     ascending oral doses in healthy male subjects and type 2 diabetic patients.~   "
204388|NCT00886353|"~     The purpose of this study is to define the dose for a Phase II study and to investigate~     safety and tolerability of intravenous administration of recombinant soluble human~     Angiotensin Converting Enzyme 2 in healthy volunteers.~   "
204389|NCT00886340|"~     The purpose of this study was to evaluate the effect of a diabetes prevention program~     provided by nurse practitioners in primary care to adults at risk for diabetes.~   "
204390|NCT00886327|"~     Up to ¾ of patients who have been diagnosed with Crohn's disease (CD) will have to undergo~     bowel resection during their lifetime despite modern medical therapies. Unfortunately,~     disease recurrence is common and endoscopic detection of recurring inflammation precedes~     clinical relapse. Endoscopic investigation is therefore recommended to manage these patients.~      This multi center, prospective study compares the conventional endoscopic method,~     ileo-colonoscopy to a new technique, i.e., colonic capsule endoscopy (CCE). CCE enables~     investigation of the small bowel and the large intestines by using a double-sided video~     camera with about 10 hours acquisition time.~      This study aims to evaluate the performance of CCE to detect postoperative recurrence of CD~     and detection rate of colonic and anastomotic recurrence is compared to ileo-colonoscopy.~     Proximal (small bowel) lesions are additionally recorded and impact on clinical management of~     the findings is accounted for. Moreover, safety aspects and influence of the findings on~     progress of the disease are monitored. All consecutive patients who are operated for CD in~     any of the participating study centers are eligible. Included are patients with segmental~     small bowel, ileocecal or segmental colonic resection.~      In some cases capsule retention has been reported at an average of 2-3% with CD patients at~     elevated risk. Therefore, patency capsule is performed before application of the video CCE to~     exclude bowel obstruction.~      Sample size estimation results in n = 70, requiring each 140 capsule endoscopes and 140~     patency capsules for performance of postoperative screening (ca 4-8 weeks postoperatively)~     and detection of postoperative recurrence (ca 4-8 months postoperatively).~   "
204393|NCT00886288|"~     This study was carried out in the context of daily medical practice to compare the~     effectiveness of telmisartan in the treatment of hypertension complicated or not with the~     presence of protein in the urine, which is called albuminuria. Hypertension is a chronic,~     treatable but not curable disease and is defined as a combination of a systolic blood~     pressure of 140 mmHg or more and a diastolic pressure of 90 mmHg or more. The kidneys are~     often the first organs damaged by hypertension; renal damage could easily be diagnosed using~     a urine dipstick and should be part of a routine examination in hypertensive patient. The aim~     of the study is to see if the decrease of blood pressure (both systolic and diastolic) after~     approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same~     or different to that in patients without albuminuria. Every patient participating should have~     two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few~     questions about is concomitant disease and drugs were asked.~   "
204394|NCT00886275|"~     In intensive care unit, patients suffered pain and anxiety from mechanical ventilation,~     presence of endotracheal tube, central venous catheter, postoperative wound, and invasive~     procedures. Adequate analgesia and sedation can reduce pain and anxiety. However, traditional~     sedatives carry the risk of unstable hemodynamic status, respiratory depression, increased~     mechanical ventilation time, incidence of delirium, and length of ICU stay. Dexmedetomidine~     is a highly selec¬tive α2-adrenergic receptor agonist which causes sedative effects and~     reduces opioid requirements in the perioperative period. Memis et al had found that~     dexmedetomidine may prevent inflammatory effects in sepsis patients during sedation.~     Oxidative stress status is related to the inflammatory response. Moreover, oxidative stress~     may result in dysfunction of microcirculation. Dysfunction of microcirculation may cause~     vasoconstriction or microthrombosis, and it will impair tissue perfusion and result in organ~     dysfunction. The goal of this study is to compare the effects of dexmedetomidine and~     midazolam on requirement of analgesics, weaning parameter, hemodynamic status, time of~     extubation, incidence of delirium, and length of ICU stay, oxidative stress status, and~     microcirculation.~   "
204395|NCT00886262|"~     The purpose of this study is evaluate the medication vasopressin for its ability to preserve~     kidney function in patients undergoing liver transplantation.~   "
204396|NCT00886249|"~     The purpose of this study is to evaluate and compare the depth of focus and visual outcomes~     after implantation of the Acrysof IQ SN60WF aspheric intraocular lens (IOL) and the Acrysof~     Natural SN60AT spherical IOL.~   "
204397|NCT00886236|"~     The purpose of this research study is to evaluate the drug gabapentin (Neurontin®) for its~     ability to reduce postoperative pain, the need for morphine-like pain medication, and the~     severity and frequency of postoperative nausea and vomiting in laparoscopic gastric bypass~     surgery patients.~   "
204398|NCT00886223|"~     The aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic~     sacropexy regarding perioperative data, objective anatomical results and postoperative~     quality of life.~   "
204399|NCT00886210|"~     Patients and methods: 100 patients were included in this study. They divided into two groups,~     group (A) with drain and group (B) without drain. The investigators recorded the effect of~     drainage on, postoperative pain (Po-P) using visual analogue scale VAS at 6, 24, 48 hours and~     1 week postoperative nausea/vomiting at 6, 24, 48 hours postoperative, abdominal collection,~     hospital stay, chest complication, and postoperative body temperature.~   "
204400|NCT00886197|"~     Gastroesophageal reflux disease (GERD) is a common disorder in Asia that includes erosive and~     non-erosive counterparts. The evaluation of intra-esophageal damage is of paramount~     importance because patients with erosive and those with non-erosive GERD have distinct~     manifestations and prognoses. Although proton-pump inhibitor (PPI) is the treatment of choice~     for erosive patients with excellent therapeutic response, the majority of reflux patients can~     be classified with non-erosive reflux disease (NERD).Narrow-band imaging (NBI) is a novel,~     noninvasive optical technique that adjusts reflected light to improve the contrast of~     capillary patterns compared with conventional illumination. Based on the standard procedure~     of sequential conventional white-light, NBI, and magnified NBI, the investigators have~     validated the reliability of the diagnostic testing. The investigators will also enroll NERD~     patients to test their therapeutic response to rabeprazole. The investigators can find out~     the best strategy to identify the PPI responder.~   "
204401|NCT00886184|"~     The aim is to precise the place of therapeutic hypothermia induced before Return of~     Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms~     of biomarkers in inducing in early hypothermia compared to hypothermia induced only after~     arrival at the hospital, there will be arguments to develop a higher scale study, allowing to~     prove benefits in terms of survival and neurological status.~   "
204402|NCT00886171|"~     The purpose of this study is to examine the effect of social skills training on adolescents~     physical activity levels. For one week at the beginning and end of the study teens will wear~     a BioTrainer to measure their activity levels and also wear a pager to communicate the types~     of activities they are doing throughout the day. For 8 weeks participants will be randomized~     into one of two groups, a social skills training group or a physical activity group.~      The investigators predict that both groups will experience an increase in physical activity~     and social involvement (decrease time spent alone).~   "
204403|NCT00886158|"~     Viral infections are an important complication of transplantation. Immunosuppressive therapy~     interferes with T cell immunity resulting in a high incidence of viral infection. Newer~     agents, such as mycophenolate mofetil (MMF) and sirolimus, have been associated with an~     increased risk of herpes virus infection. The introduction of these more potent~     immunosuppressive agents over the past decade correlates with an increase in the rate of~     hospitalizations of transplant patients with infections. This prospective study will~     determine the role of sub-clinical herpes virus infections in the development of~     complications such as chronic allograft nephropathy (CAN) and Post Transplant~     Lymphoproliferative Disease (PTLD). By focusing on treatable herpes virus infections, these~     studies have the potential to identify therapeutic strategies that can be used to diminish~     the burden of graft loss from CAN, significantly improving renal allograft survival and~     quality of life in transplant patients. Future specific interventions to test the hypothesis~     of a direct causal relationship between sub-clinical herpes virus infection and CAN may~     include the use of anti-viral therapy in response to sub-clinical infection of the renal~     allograft and/or peripheral blood.~   "
204405|NCT00886132|"~     This is a phase II study to evaluate the effectiveness of study drug sunitinib malate in~     patients with recurrent and/or metastatic adenoid cystic carcinomas of the salivary gland.~     There currently is not standard of care for this type of cancer and it has hoped that~     sunitinib will have antitumor effects on patients with this type of cancer.~   "
204406|NCT00886119|"~     The purpose of the trial is to compare the performance of two multifocal contact lens~     systems/products in established presbyopic subjects.~   "
204407|NCT00886106|"~     Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and~     leads to deterioration of quality of life. An injury or wound can lead to long term changes~     in the nervous system that make the skin more sensitive at and near the injury; this is~     termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the~     synaptic interaction between neurons.~      Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in~     animal studies the investigators have discovered previously unrecognized effects of opioids.~      Intradermal injection of capsaicin (injection of pepper extract into the skin) is an~     established pain model in humans. The investigators want to test the influence of~     remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal~     capsaicin in human volunteers in a double blind cross-over prospective active placebo~     controlled clinical trial.~   "
204408|NCT00886093|"~     The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a~     35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult~     volunteers will receive a single dose of the drug once when fasted and again when fed. The~     safety and tolerability of the drug will be monitored.~   "
204409|NCT00886080|"~     Atrial fibrillation (AF) is connected with an increased morbidity and mortality. In addition,~     quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. AF is~     frequently associated with valvular and coronary disease. In the AF patients undergoing~     valvular or coronary surgery the arrhythmia almost always relapses. For symptom control~     anti-arrhythmic drugs and cardioversion are used but breakthrough arrhythmias and side~     effects of the drugs happen frequently. For more effective symptom control add-on~     arrhythmia surgery is being advocated. However, at present the investigators do not know~     whether add-on arrhythmia surgery indeed affects morbidity and quality of life.~      The hypothesis being studied is that add-on arrhythmia surgery in patients with AF undergoing~     valvular or coronary surgery improves quality of life, establishes chronic sinus rhythm and~     reduces perioperative and long-term morbidity associated with AF.~   "
204410|NCT00886067|"~     The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's~     (NNRs) and to determine the relation between plasma concentration of AZD1446 and the~     occupancy at α4β2 NNRs.~   "
204411|NCT00886054|"~     The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial~     pressure (ICP) and clinical outcome of neurocritical patients.~   "
204412|NCT00886041|"~     In this randomized controlled trial the investigators were looking for the best policy for~     management of women with unexplained infertility after normal hysterosalpingogram (HSG). The~     investigators test the hypothesis that postponing or even bypassing laparoscopy does not~     affect the outcome of management of women with apparently unexplained infertility.~   "
204413|NCT00886028|"~     Liposomal doxorubicin consists on doxorubicin encapsulated in liposomes that are composed of~     phosphatidylcholine and cholesterol. Liposomal doxorubicin can extravasate into tumors with~     abnormal vascular endothelium but may not penetrate normal tissues lowering its toxicity and~     increasing its efficiency. Combining Liposomal doxorubicin with cisplatin could be an~     effective new chemotherapy treatment for malignant pleural mesothelioma .~      Hypothesis:~      Liposomal doxorubicin combined with cisplatin could increase response rates to chemotherapy,~     progression free survival and overall survival in patients with malignant pleural~     mesothelioma.~   "
204414|NCT00886015|"~     Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious~     cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the~     eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub~     against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO)~     has endorsed a multi-faceted strategy to combat trachoma which includes surgery to repair~     lids distorted by trachoma (trichiasis) in imminent danger of vision loss. Current evidence~     suggests that long-term success rates of trichiasis surgery are less than optimal due to~     variation in surgical technique. Previous research by this study team has demonstrated that~     shorter incisions have a higher rate of trichiasis recurrence. In addition, observations by~     this team's oculoplastic surgeon have led to the hypothesis that granuloma formation and lid~     contour abnormalities may result from current surgical practices. The objective of this study~     is to compare outcomes of trichiasis surgeries performed with the newly developed~     trachomatous trichiasis (TT) clamp versus surgeries following standard technique (bilamellar~     tarsal rotation procedure or BLTR).~   "
204415|NCT00886002|"~     The primary objective of this pilot trial is to identify pain model(s) which allow(s) to~     compare and differentiate the analgesic effects between transdermal fentanyl 25Âµg/h,~     transdermal fentanyl 12Âµg/h and placebo in a dose dependent way. The second objective is to~     compare the effects of transdermal buprenorphine 35Âµg/h in these models with the effect of~     the two transdermal fentanyl dosages. Therefore four different treatments are given; all~     treatments will be by means of a patch that is attached to the back for 72 hours.~   "
204416|NCT00885989|"~     This study will investigate the safety and tolerability of the first IV dosing of SLV338 in~     healthy volunteers.~   "
204438|NCT00885703|"~     Cryptococcal meningitis (CM) is an infection of the membranes covering the brain and spinal~     cord, caused by the fungus Cryptococcus neoformans. CM most often affects people with~     compromised immune systems, like those with advanced HIV infection. This study explored the~     safety, tolerability, and therapeutic effect of a new treatment regimen with high-dose~     fluconazole for management of CM in HIV-infected patients.~   "
204439|NCT00885690|"~     Cognition is one of the core symptoms of schizophrenia. This study is a head-to-head trial~     between olanzapine and sertindole with cognition as primary outcome. The design is a 12-week~     double-blinded randomized controlled flexible dose study.~   "
204720|NCT00881985|"~     The objectives of this study are to investigate the effect of continuous positive airway~     pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects~     with resistant hypertension and moderate obstructive sleep apnea (OSA).~   "
204417|NCT00885976|"~     This study is intended to provide additional insight into the factors affecting~     health-related quality of life with pediatric chronic pain as perceived by the patient versus~     his or her parents.In doing so, additional insight into the subjective interpretation the~     pediatric chronic pain experience will be gained. The four objectives of this study will be~     (a) to examine further the relationship between patient self-reported health-related quality~     of life and parent proxy-reported health-related quality; (b) to identify what biological,~     psychological, and/or social factors are the strongest predictors of a pediatric chronic pain~     patient's self-reported pain intensity and self-reported health-related quality of life, in a~     diverse cohort of patients referred to and subsequently treated by an anesthesiology-based~     yet interdisciplinary pediatric chronic pain medicine program; (c) to assess the effect of~     patient-specific, pain-focused biopsychosocial treatment regimen on pain intensity and~     health-related quality of life; and (d) to determine the effect of patient/parental~     satisfaction with on-going health care on their compliance with and uptake of the pain~     treatment regimen.~   "
204418|NCT00885963|"~     This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral~     sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed~     by 7-day rest in patients who have had one prior chemotherapy regimen for advanced Non-Small~     Cell Lung Cancer (NSCLC).~   "
204419|NCT00885950|"~     The purpose of the study is to determine whether anticoagulant use (i.e. salicylates,~     clopidogrel, low-molecular weight heparin, or coumarin derivates) is able to prevent the~     development of the sinusoidal obstruction syndrome secondary to oxaliplatin-based neoadjuvant~     chemotherapy in patients suffering from colorectal liver metastases.~   "
204420|NCT00885937|"~     The study is focused to prove a favorable safety profile of the new formulation.~   "
204421|NCT00885924|"~     Some patients undergoing cardiac surgery develop excessive postoperative bleeding.~     Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the~     ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired platelet~     disorders. In this study the investigators will investigate wether desmopressin reduces~     postoperative microvascular bleeding. The investigators will investigate wether desmopressin~     reduces platelet activation as measured by plasma concentration of neutrophil activating~     peptid 2 and by flow cytometry. The primary endpoint of the study will, however, be total~     postoperative bleeding and need for transfusions of blood components after surgery. The need~     for transfusions will be registered during the whole hospital stay. Patient with excessive~     postoperative bleeding (more than 250 ml for one hour, or more than 150ml for two hours~     during the first four hours) will be randomized into two groups and given either desmopressin~     or placebo (0,9% sodium chloride) as an intravenous infusion. Blood samples for plasma~     concentration measurements will be drawn before infusion of desmopressin/placebo, immediately~     after the infusion and 20 hours postoperatively. Postoperative bleeding will be registered~     for 16 hours. The need for any transfusions of blood products will be registered for the~     whole hospital stay.~   "
204422|NCT00885911|"~     The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically~     engineered for use both as a stand-alone laryngeal mask airway (LMA) and as a rescue device~     or Plan B device in the event of a difficult airway. As with some other types of LMA, it is~     then possible to insert an endotracheal tube (ETT) through the Air-Q® ILA, either blindly or~     mounted on a fibreoptic bronchoscope (FOB), to achieve endotracheal intubation. This will be~     a prospective observational study of the Air-Q® ILA's performance.~   "
204423|NCT00885898|"~     In the past, patients suffering from acute respiratory failure had to be treated with Oxygen~     and specific medication, or - if this had not been sufficient - had to be anesthesized and~     had to undergo endotracheal intubation for invasive ventilation. Nowadays, since emergency~     ventilators are available that can be used for non-invasive ventilation, the purpose of this~     study is to investigate if non-invasive ventilation is safe, feasible and effective for the~     treatment of acute respiratory failure and if less patients will need to be intubated~     out-of-hospital as well as in the further course.~   "
204424|NCT00885885|"~     The purpose of the study is to evaluate the efficacy and safety of the combination of~     Panitumumab with FOLFOX 4 Chemotherapy or Panitumumab with FOLFIRI Chemotherapy in Subjects~     with Wild- Type KRAS Colorectal Cancer and liver-only Metastases.~   "
204425|NCT00885872|"~     This study is to evaluate the effect of rosuvastatin 10-20 mg on carotid atherosclerosis~     progression in Chinese patients by evaluating the change in the percentage of volume of lipid~     rich necrotic core (LRNC) using high-resolution magnetic resonance imaging (MRI) after~     24-months treatment.~   "
204426|NCT00885859|"~     -  Transcutaneous electrical nerve stimulation (TENS) is a frequently applied therapy in~          chronic pain. Although evidence regarding the effectiveness of TENS in chronic pain is~          inconclusive many patients continue using TENS on long term in daily practice. An~          important question is therefore why some patients respond well and others don't at all.~          In chronic pain evidence for abnormal pain processing (sensitization) has been found in~          several patients groups. The process of sensitization might influence effectiveness of~          TENS as the theoretical working mechanism of TENS is based on the modulation of the~          transmission of nociceptive impulses form peripheral receptors throughout spinal nerve~          system into the brain. In this study we want to study the effect of TENS on pain~          transmission, as measured by contact heat evoked potentials (CHEPS), between~          'responders' and non-responders' after a two weeks TENS treatment. 'Responders' will be~          defined as patients with a pain reduction of ≥ 30% on a VAS after a two week treatment~          period with TENS. Non-responders are patients with a pain reduction < 15%.~        -  Objective: a) Is pain reducing effect TENS in responders based on modulation of pain~          transmission and perception, as measured by CHEPS? b) Is the ability of TENS to modulate~          pain transmission and perception influenced by abnormal pain processing?~        -  Prospective cohort study~        -  Patients with chronic non specific pain (duration > 6 months), above 18 year, will be~          included. Patients are referred from the Pain Clinic of the University Hospital~          Maastricht (MUMC). Exclusion criteria are: a) pain due to cancer, b) the use of a~          cardiac pacemaker, c) pregnancy, d) neurological sensory deficits, e) language and/or~          cognitive inability to complete the health assessment questionnaires f) previous TENS~          for pain relief.~        -  Patients receive a two week treatment period with TENS-treatment, as regular, at home~          after instruction. The frequency is set at 100 Hz and pulse duration at 250 μ sec.~          Patients have to use the TENS daily (minimal 4 times a day for 30 minutes).~      Main study parameters/endpoints are decrease in amplitude of CHEPS in responders versus~     non-responders.~   "
204440|NCT00885677|"~     The objective of this study is to compare two different strategies of disease management in~     heart failure patients treated with cardiac resynchronization therapy devices~        1. Remote monitoring with CareLink Network System~        2. Standard management of the disease by means of scheduled routine in-patient follow-ups;~      and to demonstrate that the remote monitoring strategy is superior to the standard strategy,~     both in terms of clinical effectiveness and total healthcare system utilization.~   "
204721|NCT00881972|"~     This study will test the effects of daily physical activity on variations in blood glucose~     control.~   "
204427|NCT00885846|"~     Qigong therapy is a subtle energy-based methodology for preventing and healing diseases that~     has been practiced with remarkable results in China for about five thousand years. Recently,~     preliminary studies showed that Qigong exercises improve insulin resistance and glucose~     metabolism in people with type 2 diabetes. These studies suggest that Qigong therapy might be~     an effective and valuable complementary modality for treating type 2 diabetes. Type 2~     diabetes is a chronic disease marked by abnormally high levels of sugar in the blood.~     Diabetes is a serious disease, which, if not controlled, can be life threatening.~      The purpose of this project is to conduct a randomized, controlled pilot clinical trial to~     compare the effectiveness of Qigong therapy to mild exercise and conventional treatment in~     type 2 diabetes and to identify biological and psychological characteristics associated with~     subjects' responses to Qigong therapy.~      Aim 1: To compare the effects on blood sugar and hemoglobin A1c (HbA1c) level between a~     Qigong therapy group and non-treated control group as well as between Qigong group and a~     progressive resistance training (PRT) group before, during and after and 12-week~     intervention.~      Hypothesis 1: Both Qigong therapy and PRT will help type 2 diabetic patients reduce blood~     sugar levels to different degrees through improving insulin resistance. But the levels of~     reduction of blood sugar will be greater by Qigong therapy than by PRT due to enhanced~     insulin secretion.~      Aim 2: To compare the effects on fasting C-peptide and insulin levels between a Qigong~     therapy group, a PRT group and a non-treated control group before and after the intervention.~      Hypothesis 2: Qigong therapy will increase the endogenous insulin and C-peptide levels by~     restoring the functions of the pancreas, while PRT will not alter either insulin or C-peptide~     levels.~      Aim 3: To compare the effects of Qigong therapy and PRT on blood cortisol levels and~     psychological stress levels before, during and after the intervention.~      Hypothesis 3: Perceived stress and depression will be improved by Qigong therapy to a greater~     extent than by PRT, and blood cortisol levels will be reduced to a greater extent with Qigong~     therapy.~   "
204428|NCT00885833|"~     Wiskott-Aldrich syndrome (WAS) is a rare X-linked congenital immune-deficiency syndrome and~     hematopoietic stem cell transplantation (HSCT) has become a curative modality. But the~     transplant with the conventional conditioning resulted in high incidence of treatment related~     toxicities and non-myeloablative conditioning resulted in high incidence of engraftment~     failure. Recently, fludarabine based reduced toxicity myeloablative conditioning regimen was~     developed for adult myeloid malignancies with promising result of good engraftment and low~     treatment related toxicities. To increase the engraftment potential without serious~     complication, reduced toxicity myeloablative conditioning regimen composed of fludarabine,~     busulfan, and thymoglobulin is designed for Wiskott-Aldrich syndrome.~   "
204429|NCT00885820|"~     This multicentre randomized, controlled trial (RCT) compared renal allograft histology and~     function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol~     biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.~   "
204430|NCT00885807|"~     The purpose of the study is to evaluate the psychometric validation of the Weiss Functional~     Impairment Rating Scale and the Weiss Symptom Record. It is hypothesized that the Weiss~     Functional Impairment Rating Scale has strong psychometric properties and good convergent~     validity with other measures of functioning and discriminant validity from symptoms and~     quality of life.~   "
204431|NCT00885794|"~     Diabetic maculopathy is the leading cause of visual impairment in the working-age population~     in developed countries. Diabetic macular edema can cause impaired visual acuity and so far is~     treated by laser, vitreous surgery, and intravitreal cortisone application. Still 50% of the~     cases do not respond to the treatment.~      Recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis) in diabetic~     macular edema has proven efficacy to last over a period of 3 to 6 months. Still, the optimal~     dosage for those intravitreal injections still has to be found, because frequent injections~     are necessary.~      The measurement of visual acuity is inadequate to quantify in detail the visual impairment.~     Using the newest technology of a high-definition optical coherence tomography (Cirrus-OCT,~     Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a miroperimetry (MP-1, Nidek~     Technologies) to determine retinal sensitivity, we hope to find the optimal dosage of~     intravitreal anti-VEGF treatment in diabetic macular edema.~      Study objective: To determine the dose response of 0.5mg and 1.0mg ranibizumab (Lucentis®,~     Novartis Pharma) intravitreal injection in subjects with resistant diabetic macular edema and~     evaluate safety and tolerability.~   "
204432|NCT00885781|"~     Comparison of efficacy and safety of two lipid emulsion products will be performed on~     gastrectomy patients postsurgically.~   "
204433|NCT00885768|"~     All patients referred for coronary angiography will simultaneously be evaluated for renal~     artery stenosis and then stenosis more than 50% will be analyzed according to clinical~     conditions, risk factors and lab data.~   "
204434|NCT00885755|"~     This single arm study will evaluate alterations in molecular marker expression in~     HER2-positive targeted therapy, and will evaluate the effect of continued treatment with~     Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy.~     Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading~     dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease~     within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda~     (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken~     for biomarker and gene profiling evaluation. The anticipated time on study treatment is until~     disease progression, intolerable side effects or patient choice, and the target sample size~     is 100 individuals.~   "
204435|NCT00885742|"~     Congenital deficiency of factor XIII (FXIII) is an extremely rare inherited disorder~     associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to~     patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood~     in the usual clotting process, thereby preventing bleeding.~      In this study, patients will be treated with FXIII Concentrate (Human) and followed closely~     to determine that they receive the dose that will best minimize the chance of bruising and~     bleeding.~   "
204436|NCT00885729|"~     The purpose of this study is to:~        -  Compare the treatment efficacy of autologous mesenchymal stem cells (Mesenchymal Stem~          Cells) versus chondrocytes implanted in a commercial available scaffold in a human~          clinical trial.~        -  Determine the effects of specific three months strength training program preoperatively~          to improve knee function and possible postpone the need of cartilage repair surgery.~        -  Determine if degenerative changes occur in the knee joints following cartilage repair.~          This question will be investigated in the proposed clinical trial.~        -  Determine the characteristics of patients treated either by surgery or by rehabilitation~          in a long-term follow-up (1, 5 years).~   "
204437|NCT00885716|"~     Patients suffering from schizophrenia who attend the communication skills program engage more~     deeply in therapeutic reasoning and treatment decisions. This results in stronger preferences~     to participate, greater perceived involvement and better long term adherence compared to~     patients who do not attend the training.~   "
204938|NCT00879112|"~     A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and~     tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12~     weeks followed by a 6-week off drug phase.~   "
204442|NCT00885651|"~     Heart failure is a frequent disease in Denmark, and it is associated with very high~     mortality. Around 60,000 people in Denmark have heart failure, and there is about 11,000~     hospitalizations every year due to this disease. From the time of diagnosis, patients survive~     an average of 4-5 years.~      A critical illness mechanism in heart failure is that these patients have high blood levels~     of catecholamines; epinephrine and norepinephrine, which is stress hormones from the~     sympathetic nervous system. Standard treatment of heart failure is with the two medical~     preparations betablockers and ACE-inhibitors.~      It is not known what effect betablocker-treatment have on blood concentration of epinephrine~     and norepinephrine.~      It is the purpose of this study, to investigate the effect of Selo-Zok ® (metoprolol) on the~     blood concentration of epinephrine and norepinephrine. This is done by creating a stress~     condition for the body, in this case with the bicycle test, while doing blood samples to~     determine the concentration of catecholamines. This will be done by 1-week treatment of~     tablet Selo-Zok ® followed by 1-week treatment of placebo (a substance with no medical~     effect). Blood samples will be taken to determine small changes in inheritance material (DNA)~     in the form of point mutations also called single nucleotide polymorphisms, since these~     changes can affect how we respond to metoprolol treatment.~   "
204443|NCT00885638|"~     The regulation by DPP-4 inhibition after ingested of different individual macronutrients is~     not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose~     or mixed meal on the concentrations of incretin hormones and insulin secretion with or~     without concomitant administration of a DPP-4 inhibitor (sitagliptin).~   "
204444|NCT00885625|"~     Hypothesis: the efficacy of 2 doses 7-valent PCV is equivalent to 1 dose 7-valent PCV.~   "
204445|NCT00885612|"~     10-year CHD risk evaluation and its treatment pattern analysis in postmenopausal early breast~     cancer patients taking aromatase inhibitors.~   "
204446|NCT00885599|"~     Gingivitis, defined as inflammation of the gingival tissues, has long been associated with~     bacterial accumulation [plaque] on the tooth surface adjacent to the gingiva, causing an~     inflammatory reaction. Experimental gingivitis in health adults can be induced by abstension~     from brushing teeth for 9 to 21 days, and can test the effects of numerous chemotherapeutic~     agents, rinses and toothpastes. Effective prevention of plaque accumulation can prevent~     destructive forms of periodontal disease.~      A recent link has been established between localized gingival inflammation and systemic~     inflammation and a number of disease processes. Periodontal disease may lead to elevated~     C-reactive protein [CRP], considered a potential risk factor for cardiovascular disease and~     stroke. It has been shown that reducing gingival inflammation is accompanied with a~     significant decrease in serum CRP levels.~      Naturopathic remedies for treating oral disease have been well documented in the medical and~     dental literature since early civilization, and have become more and more popular in recent~     years. We propose to study one such remedy, PERIORINSE. This remedy consists of a number of~     herbs, and has been shown to exhibit antibacterial and anti—inflammatory effects.~     Specifically, it has been shown to block the proteolytic effects seen in gingival~     inflammation . This study will evaluate the efficacy of this formulation, using currently~     accepted clinical testing protocols.~      A Random sample of 100 healthy volunteers who fulfill all inclusion criteria and no exclusion~     criteria, will be included in the study. Patients will randomly selected to one of 4~     treatment groups: PERIORINSE (n=25), CPC (Cepacol) mouthwash (25 patients), Listerine~     mouthwash (n=25), and placebo (colored water) mouthrinse. Patients will be examined at~     baseline, and Gingival Index taken for all teeth. A blood specimen will be taken to measure~     CRP levels as well. Patients will be given a full dental prophylaxis which includes scaling~     and tooth polishing, and given rinsing instructions and reminded to cease all other oral~     hygiene methods including brushing, flossing, and rinsing with any other rinse for a period~     of 14 days. On day 14, patients will be re-examined and Gingival Index taken for all teeth.~     Patients will be given a full dental prophylaxis which includes scaling and tooth polishing~     and required to reinstitute their original oral hygiene regimen. CRP levels will be measured~     again, as well.~   "
204447|NCT00885586|"~     Symptoms that herald herpes zoster include pruritus, dysesthesia and pain along the~     distribution of the involved dermatome. The most distressing symptom is typically pain and~     the most feared complication is postherpetic neuralgia (PHN), the persistence of pain long~     after rash healing. PHN is defined as pain persisting more than 3 months after the rash has~     healed. Both, the acute pain associated with herpes zoster and the chronic pain of PHN, have~     multiple adverse effects on health-related quality of life.~      The primary objective of the trial presented is to investigate whether a 4 week~     semi-standardised acupuncture is non-inferior (first step) or superior (second step) to (a)~     the anticonvulsive drug gabapentin and (b) sham laser acupuncture in the treatment of pain~     associated with herpes zoster in addition to standardised analgesics. Secondary objectives~     include an assessment of the change of sensoric function, of long-term effectiveness, the~     occurrence of PHN and an evaluation of several pain specific questionnaires~   "
204448|NCT00885573|"~     Pharyngeal sensitivity is a determinant parameter of pharyngeal functioning, particularly~     regarding protective dilator reflexes of upper airway. Preliminary results have suggested~     that the use of this parameter in diagnosis algorithm such as linear discriminant analysis~     and random forest could predict the presence of sleep apnea syndrome in almost 98% of~     patients. Our study aims at validating a new diagnosis method of sleep disordered breathing~     which will be compared with nocturnal polysomnography, the reference method to diagnose sleep~     disordered breathing. Pharyngeal sensitivity will be measured using the SENSITEST device~     which allows an automatic measurement of the pharyngeal sensation. The use of this parameter~     in diagnosis algorithm will be compared with polysomnographic results.~   "
204449|NCT00885560|"~     To enhance our capacity to correctly choose the appropriate medication for ADHD patients on~     the first try based on the presence of a particular variant of a gene that could be~     identified on a laboratory test. It is hypothesized that patients with Attention Deficit~     Hyperactivity Disorder (ADHD) who have failed to respond to methylphenidate medication, but~     do respond to amphetamines, have a higher than expected incidence the allelic variants of the~     SNAP 25 gene associated with ADHD, and mutations of the dopamine system genes DRD1, 2, 4, 5~     and dopamine transporter and COMTand MAOA.~   "
204450|NCT00885547|"~     The purpose of this study is to:~        1. To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic~          abnormal urinalysis.~        2. To evaluate the safety and tolerability of TW.~   "
204451|NCT00885534|"~     The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT~     is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other~     investigators have used CVT in melanoma patients and found that tumors got significantly~     smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of~     how many patients will respond to CVT. Also they want to test which genes in the tumor are~     turned on and which are turned off. We hope this will teach us to know in the future which~     tumors will respond to CVT.~   "
204722|NCT00881959|"~     The purpose of the study is to evaluate whether clinical parameters for Puros Dermis are, at~     minimum, equivalent when compared to AlloDerm, the current industry standard, for the~     treatment of single, non-adjacent Miller's Class I or II gingival recession.~   "
204452|NCT00885521|"~     The aim of this project is to examine the short and long term effects of an 8 week, twice~     weekly, outpatient exercise training program for people with bronchiectasis. Participants~     will be randomly allocated to undergo a supervised exercise training program at The Alfred,~     Austin Hospital or Sir Charles Gairdner Hospital.~      The hypotheses of this study are:~        1. Patients with bronchiectasis who complete an exercise program will have a higher~          exercise capacity and better quality of life and these improvements will be sustained~          for up to 12 months after completion~        2. Exercise training will significantly reduce the incidence of pulmonary exacerbations,~          use of antibiotics and rate of hospitalisation~   "
204453|NCT00885508|"~     In this trial, the investigators will test the combination of escalating doses of~     chemotherapy (starting at relatively low dose) with lenalidomide in intermediate-2-or high~     risk MDS and AML with del 5 q31. It is hoped that this combined therapy will further increase~     response rate in intermediate-2-or high risk MDS and AML with del 5 q31, without major~     toxicity in comparison to historical results obtained with chemotherapy alone in the same~     subset of patients.~   "
204454|NCT00885495|"~     This is a phase I, open-label, controlled drug interaction study to determine the effects of~     darunavir plus ritonavir on the pharmacokinetics of the hydroxymethylglutaryl coenzyme A~     (HMG-CoA) reductase inhibitor, rosuvastatin, in HIV-1-seronegative subjects.~   "
204455|NCT00885482|"~     Objectives of the study:~        1. To verify the safety of the study treatment, defined as the persistent control of the~          virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with~          ritonavir.~        2. To collect relevant information about the safety and the metabolic impact of this~          strategy in order to eventually design a non-inferiority randomized controlled trial for~          the evaluation of the safety and the efficacy of this strategy in the future.~   "
204456|NCT00885469|"~     Study Hypothesis:~        -  PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded~          esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting~          and grading esophagitis.~        -  PillCam™ ESO will demonstrate all safety parameters as compared to EGD~        -  PillCam™ ESO-2 will demonstrate better patient's satisfaction as compared to EGD~   "
204457|NCT00885456|"~     The objective of the Program of Rehabilitative Exercise and Education to avert Vascular~     Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to~     determine whether the timely delivery of secondary stroke prevention strategies will reduce~     modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One~     group will receive a comprehensive education and exercise program (PREVENT); the other group~     will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in~     both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity,~     walking endurance, and daily physical activity. In addition, we will compare thinking~     ability, depression, achievement of personal goals for healthy behavior, and health-related~     goal attainment and health-related quality of life. Finally, we will compare outcomes in~     urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to~     assess sustainability of the PREVENT program.~   "
204458|NCT00885443|"~     Emergence delirium (ED) refers to a wide variety of behavioural disturbances that are~     commonly seen in children following emergence from anesthesia. ED can potentially be~     dangerous and have serious consequences for the child such as injury, increased pain, and~     dislodgement of medical devices, often requiring physical restraint or pharmacological~     control. Witnessing this behaviour can be stressful for parents, which can negatively affect~     their interaction with the healthcare system, and their relationship with the child, nursing~     staff and other healthcare providers. The investigators aim to minimize ED to reduce the~     distress experienced by patients and their parents. This study will compare the recovery~     profile of sevoflurane with that of propofol remifentanil and their associated incidence of~     ED. This study should enable us to determine which form of anesthesia is associated with the~     fewest incidences of ED in children.~   "
204459|NCT00885430|"~     Twenty adult volunteers will be administered Pico-Salax in the usual fashion for colonoscopy~     with intense monitoring of serum and urine chemistry and hemodynamics.~   "
204460|NCT00885417|"~     Helicobacter pylori infection has been shown to be associated with the development of gastric~     cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the~     occurence or recurrence of these diseases. However, it was estimated that 15-20% of patients~     would fail from first line standard eradication therapy and need second line rescue therapy.~     About 15-30% of patient would fail from second line therapy and need to be rescued with third~     line therapy. The commonly used salvage regimens include:~        1. Bismuth based quadruple therapy (combined with ranitidine or proton-pump inhibitor (PPI)~          plus two antibiotics)~        2. Levofloxacin or moxifloxacin or rifabutin based triple therapy.~      However, Bismuth is not available in many countries and the administration method is complex.~     Its usage is limited by the high pill number and low compliance rate. In recent years, the~     concept of sequential therapy has been advocated in the treatment of H. pylori infection. The~     regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin~     and metronidazole for another five days. The eradication rate in the first line treatment of~     sequential therapy had been reported to be as high as 90%. More importantly, it has been~     demonstrated that the eradication rate among patients with clarithromycin-resistant strains~     could be as high as 89%.~      Aims: Therefore, the investigators aim to assess the efficacy of levofloxacin-based~     sequential therapy as second line therapy for those who fail from one standard eradication~     therapy.~   "
204461|NCT00885404|"~     The purpose of this study is to determine whether intravenous fluid management using lower~     chloride solutions (Hartmann's solutions and Plasmalyte®) will result in better outcome when~     compared to management using high chloride solutions (0.9% saline and Gelofusine®).~   "
204462|NCT00885391|"~     The purpose of this study is to learn whether the chemicals in the blood and urine are~     different when the heart is atrial fibrillation compared to normal sinus rhythm.~   "
204463|NCT00885378|"~     The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for~     participants taking saxagliptin in combination with metformin immediate release (IR) versus~     metformin IR alone.~   "
204723|NCT00881946|"~     The purpose of this study is to characterize the safety and tolerability of repeat doses of~     compound GSK2110183 in subjects with hematologic cancer.~   "
204464|NCT00885365|"~     The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is~     non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one~     second (FEV1) percent of predicted normal, and to compare the safety in participants with~     cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.~   "
204465|NCT00885352|"~     This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431)~     compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic~     control who are taking pioglitazone and metformin.~   "
204466|NCT00885339|"~     The purpose of this study is to compare two preparation and procedure in order to develop the~     most optimal capsule procedure in regards to colon cleansing level and capsule excretion~     rate.~   "
204467|NCT00885326|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Zoledronic acid may stop the growth of tumor~     cells in bone. Giving bevacizumab together with cyclophosphamide and zoledronic acid may kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of giving bevacizumab together with~     cyclophosphamide and zoledronic acid in treating patients with recurrent or refractory~     high-risk neuroblastoma.~   "
204468|NCT00885313|"~     The purpose of this interventional study is to evaluate the efficacy and tolerability of~     docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver~     biopsy confirmed nonalcoholic fatty liver disease (NAFLD).~   "
204469|NCT00885300|"~     The purpose of this study is to investigate whether cloxacillin lock is effective in~     prevention of double lumen infection.~   "
204470|NCT00885287|"~     As HIV/AIDS is spreading in malaria-endemic countries, many patients here will need~     concomitant treatment for both infections. Effective combination treatments are available for~     both malaria (artemisinin-based combination treatments, ACTs) and HIV/AIDS (antiretroviral~     combination treatments, ARTs), and these treatments are presently recommended for concomitant~     use by ministries of health in many endemic countries, including Tanzania. However,~     theoretically some of these drugs may be involved in harmful interactions with each other, as~     they share common cytochrome enzymes involved in their metabolism. Such interactions could~     lead to less effective treatments and/or adverse effects, as a consequence of reduced or~     increased drug levels, respectively. Only little clinical and pharmacological information is~     however yet available to guide clinicians and policy-makers on this issue.~      The main aim of the InterACT study in Tanzania is to conduct a series of detailed~     observational studies of clinical and paraclinical safety, therapeutic efficacy and~     pharmacokinetic interactions between the currently nationally recommended first-line~     treatment for malaria, artemether-lumefantrine, and first-line antiretroviral treatments,~     primarily nevirapine-based combinations, for HIV/AIDS. The studies will be conducted among~     patients with uncomplicated malaria, who attend the HIV/AIDS Care and Treatment Clinic and~     Muheza Designated District Hospital in Muheza, north-eastern Tanzania, which is an area~     characterized by intense transmission of Plasmodium falciparum malaria and with a prevalence~     of HIV around 8-10%. The study is expected to inform guidelines for the treatment of malaria~     in patients with HIV/AIDS in Tanzania, and elsewhere.~   "
204471|NCT00885274|"~     Pico-Salax is an osmotic and stimulant bowel cleansing agent used prior to colonoscopy. It is~     unknown whether splitting the doses (i.e. taking the second dose the morning of the~     colonoscopy) results in a better bowel cleansing, as research with other agents suggests this~     may be the case. This study aims to assess whether splitting the dose of Pico-Salax results~     in a better bowel cleansing than traditional dosing.~   "
204472|NCT00885261|"~     Obesity is considered as the epidemic of the century. Central obesity is one of the metabolic~     syndrome's features. It has been proven that obesity can cause back pain and headaches; thus,~     there might be a link between chronic pain and the syndrome.~      The objective of this study is to assess the prevalence of metabolic syndrome in patients~     suffering from chronic pain.~   "
204473|NCT00885248|"~     In suspecting pancreatic cancer, dynamic phase pancreatic CT is the most effective tool in~     diagnosis and staging. In addition, magnetic resolution image, endoscopic ultrasonography,~     endoscopic retrograde pancreatography, angiography can be performed.~      After introduction of functional image, PET has been suggested in the role of diagnosis and~     staging of pancreatic cancer. Furthermore, recently fused images of PET and CT were~     available.~      In this study, the researchers evaluate the role of integrated PET-CT in patients with~     pancreatic cancer and analysis the cost-effectiveness of the integrated PET-CT.~   "
204474|NCT00885235|"~     The purpose of this study is to evaluate the effect of the PCCE preparation and procedure on~     colon cleansing level and excretion rate.~   "
204475|NCT00885222|"~     The purpose of this study is:~        1. To determine, in the context of a prospective clinical trial, whether stimulation~          parameters in PD patients treated with DBS, are associated with antidepressant effects.~        2. To determine whether these antidepressant effects are related to or independent of~          changes in the motor features of PD.~        3. To establish a computerized database that includes stimulation parameters and clinical~          parameters in PD patients treated with DBS.~        4. To develop a computer-assisted decision making protocol for programming of DBS~          parameters in both depressed and non-depressed PD patients.~   "
204476|NCT00885209|"~     The purpose of this study is to evaluate the effect of a modified Prep and procedure on colon~     cleansing level and capsule excretion rate.~   "
204477|NCT00885196|"~     This study is designed to provide efficacy and safety data of several doses of AEB071 so that~     the optimal dose and treatment duration can be chosen for testing in later studies in~     patients with plaque psoriasis (with a disease severity such that systemic treatment is~     justified). The treatment free Follow-up Period is designed to provide additional safety data~     and information on disease recurrence after the last dose of the study drug.~   "
204509|NCT00884767|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin~     for cancer may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to neurotoxicity.~      PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients~     with colorectal cancer receiving oxaliplatin.~   "
204478|NCT00885183|"~     Breast cancer patients report many symptoms while undergoing conventional care, including~     nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address~     these common side effects of treatment are limited. Patients diagnosed with cancer frequently~     seek complementary medicine (CAM), and there is a need to investigate potential effects of~     CAM therapies. This phased pilot and feasibility study has two aims:~        1. Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast~          cancer patients undergoing chemotherapy using structured interviews with established~          acupuncture teams in Norway.~        2. Implement the treatment protocol in a pilot study to evaluate outcome measures, effect~          sizes and acceptability of acupuncture care delivered alongside conventional care.~      Study results will support the design of future research; including a Phase III randomised~     controlled trial.~   "
204479|NCT00885170|"~     The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and~     the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with~     alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once~     weekly will increase bone mineral density at the femoral neck compared to placebo at the end~     of 24 months.~   "
204480|NCT00885157|"~     The purpose of this study is to investigate the use of a fourth fractional booster dose of~     sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster~     dose between 15 to 18 months of age, in terms of immunogenicity and safety.~      Objectives:~        -  To describe in each group the immunogenicity of IMOVAX Polio administered intradermally~          or intramuscularly, one month after the booster dose given at 15-18 months of age in~          toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25~          study.~        -  To describe in each group the safety of the booster dose of IMOVAX Polio vaccine~          administered intradermally or intramuscularly.~   "
204481|NCT00885144|"~     The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have~     been associated with improved growth and development outcomes among infants in Ghana and~     Malawi. The investigators' study group has developed modified versions of such supplements~     that theoretically will supplement infants diets better and with lower cost. As a preparation~     for larger efficacy trials, the investigators now aim to test the acceptability of these~     supplements among Malawian infants and their guardians. The trial hypothesis is that the~     infants will consume on average at least 50% of an offered dose that consists of LNS mixed~     with maize porridge.~   "
204482|NCT00885131|"~     Background:~        -  Magnetic resonance imaging (MRI) uses a strong magnetic field and radio waves to take~          pictures of the brain. Some MRI studies suggest that this technique reveals brain~          differences in patients with a nervous system illness when compared to adults without a~          nervous system illness.~      Objectives:~        -  To study functional changes in the brain that may be observed in people without any~          nervous system illness.~        -  To learn more about which areas of the brain are necessary to perform certain tasks,~          especially learning simple motor sequences and processing rewards.~      Eligibility:~        -  Healthy volunteers between the ages of 18 and 50 who are right-handed and are native~          English speakers, and who have no medical conditions that would prevent them from~          undergoing magnetic imaging.~        -  Volunteers must not have a history of neurological or psychiatric illnesses.~        -  Female volunteers must not be pregnant.~      Design:~        -  Volunteers will be asked to undergo different types of magnetic imaging, including~          functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS),~          and/or transcranial magnetic stimulation (TMS), while participating in either a slot~          machine simulation or a key sequence learning task.~        -  Volunteers will participate in one of four possible experiments:~        -  Experiment 1: MRS/TMS and slot machine (3 visits, 3.5 hours in total).~        -  Experiment 2: MRS/TMS and key sequence (3 visits, 3.5 hours in total).~        -  Experiment 3: fMRI and slot machine (2 visits, 3 hours in total).~        -  Experiment 4: fMRI and key sequence (1 visit, 2 hours in total).~        -  Experiment types:~        -  Slot machine: A computer game like a slot machine, where the user presses a button to~          start the game and watches as the three barrels of the machine spin into place.~        -  Key sequence: Pressing a series of buttons in response to visual cues.~        -  Volunteers will also be asked to give a small blood sample for genetic testing.~        -  Volunteers will be paid a small amount of money (approximately $50 $80) during the~          experiments in compensation for their participation in the study.~   "
204483|NCT00885118|"~     The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety,~     and tolerability of once daily oral administration of BI 10773 administered for 28 days in~     Japanese patients with T2DM.~   "
204484|NCT00885105|"~     The study is to compare the 2 Groups with respect to antibody responses to inactivated~     influenza vaccine.~      Observational Objectives:~        -  To describe the percentage of participants with protective Hemagglutinin (HAI) antibody~          titers to each of the 3 vaccine antigens in both study groups following each~          vaccination.~        -  To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in~          both study groups following each vaccination.~        -  To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in~          both study groups.~   "
204485|NCT00885092|"~     The purpose of this study is to clinically evaluate an investigational multi-purpose~     disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of~     silicone hydrogel contact lenses.~   "
204486|NCT00885079|"~     The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective~     compared with active control in dry eye patients.~   "
204487|NCT00885066|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given~     together with capecitabine and erlotinib in treating patients with advanced pancreatic~     cancer.~   "
204488|NCT00885053|"~     The aim of this study is to investigate the effects of acute and short-term intervention with~     fish oil on inflammatory markers in overweight subjects.~   "
204507|NCT00884793|"~     The PLUS study is a pilot study to measure the effect of therapy intensification (with~     raltegravir and optional second agent) on HIV levels in the gut and blood in patients on~     antiretroviral therapy (ART) with viral load < 50 copies/mL (herein referred to as~     suppressed). We hypothesize that there is ongoing replication in the gut despite~     suppressive ART and that this replication can be inhibited by the addition of one or two new~     antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All~     study participants will have upper and lower endoscopy at baseline (before intensification)~     and after intensification. These endoscopies will be used to obtain gut tissue and single~     cells (for CD4+ cells) .~   "
204508|NCT00884780|"~     The purpose of this study is to test the accuracy of a computer-based program to self-report~     the location and intensity of a child's pain in comparison to a traditional self-report paper~     and pencil measure and physician physical exam. Using a computer to assess pediatric pain may~     offer many advantages and improvements in how pediatric pain is diagnosed and treated.~   "
204489|NCT00885040|"~     Background:~        -  Many people can learn to use feedback about brain activity to modify that activity, but~          is it not known if people with Tourette syndrome can modify their brain activity.~        -  Researchers have evidence that certain areas of the brain are involved in causing tics~          in people with Tourette syndrome. If people with Tourette syndrome can use feedback~          about brain activity to modify activity in those parts of the brain, they may be able to~          modify their brain activity to help control the tics.~      Objectives:~        -  To determine if people with and without Tourette syndrome can learn to use thought to~          control brain activity.~        -  To test whether people who have Tourette syndrome can learn to control brain activities,~          possibly helping to control tics.~      Eligibility:~        -  Healthy volunteers ages 18 and older who are right-handed and are willing to not consume~          caffeine or alcohol for 24 hours before the study visit.~        -  Patients with Tourette syndrome who have tics that can be observed and studied.~        -  All participants must be able to undergo magnetic resonance imaging (MRI) scans.~      Design:~        -  Healthy volunteers (two visits to the NIH Clinical Center over a 2- to 4-week period;~          visit may last up to 3 hours):~        -  Screening visit, including physical examination and medical history, and a magnetic~          resonance imaging (MRI) scan if the individual has not had one performed at the National~          Institutes of Health in the past year.~        -  Study visit: Functional MRI (fMRI) scan to allow researchers to see if volunteers can~          learn to control their brain activity during a scan. Volunteers will be asked to~          complete tasks as directed during the fMRI scan.~        -  Patients with Tourette syndrome (three or four outpatient visits over a 4- to 6-week~          period; each visit may last up to 4 hours):~        -  Screening visit, including physical examination and medical history, and an MRI scan if~          the individual has not had one performed at the National Institutes of Health in the~          past year.~        -  Evaluation visit to ask questions about Tourette symptoms and to have patients complete~          questionnaires about their tics and their mental health.~        -  Study visit: fMRI scan to allow researchers to see if patients can learn to control~          their brain activity during a scan. Patients will be asked to complete tasks as directed~          during the fMRI scan.~        -  Final visit: Researchers will ask questions about tic symptoms, have patients complete~          questionnaires, and perform a brief exam. Afterward, patients will have an fMRI scan~          similar to the previous one.~        -  All participants will be paid a small amount of money in compensation for their~          participation in the study.~   "
204490|NCT00885027|"~     This is an exploratory study, to evaluate the improvement in terms of quality of life that~     can be reached by a group of outpatients with BPH ( Benign Prostatic Hyperplasia ) and~     nocturia when they are under treatment with Secotex Ocas.~      This study will explore, the progress in terms of quality of life that can be reached by a~     group of outpatients with BPH ( Benign Prostatic Hyperplasia) and nocturia treated with~     Secotex OCAS®.~      This is a not controlled study,  before and after type, which will consist of an~     assessment, of the quality of life for outpatients with BPH symptoms including nocturia,~     through the use of the Spanish version of the Nocturia Quality-of-life (NQoL) questionnaire,~     at three different moments:~        1. Before to start Secotex OCAS® treatment.~        2. Thirty (30) days after first visit and starting Secotex OCAS® treatment~        3. Ninethy (90) days after first visit and starting Secotex Ocas® treatment~   "
204491|NCT00885014|"~     The purpose of the study is to examine the effectiveness of telephone cognitive-behavioral~     therapy for subthreshold depression and presenteeism in workplace, in comparison with~     treatment-as-usual (TAU) (which is minimal contact through Employers Assistance Program~     (EAP)).~   "
204492|NCT00885001|"~     The general purpose of this pilot study is to determine the effects of a novel exercise~     intervention (short arc banding (SAB)) on the cross sectional area of lumbar multifidus well~     as functional outcomes assessments in patients with chronic low back pain.~   "
204493|NCT00884988|"~     Ankle fractures are invariably complicated by severe soft-tissue swelling which can~     significantly prevent surgical repair (open reduction and internal fixation - ORIF) of the~     fractured bone for up to two weeks. The delay in surgical treatment can increase the risk for~     local skin and bone complications, as well as for deep venous thrombosis. Lymphomyosot® is a~     non-prescription, homeopathic complex drug which has been used for more than 70 years~     throughout Europe and the U.S., primarily for tissue edema and swelling.~      This is a randomized, placebo-controlled, double blind pilot study evaluating the~     effectiveness of homeopathic combination drug Lymphomyosot® compared to placebo treatment.~     The study will take place at the Shaare Zedek Medical Center in Jerusalem, Israel. Adult~     patients (age 18 years and older) admitted to the orthopedic department with acute ankle~     fractures which require ORIF repair will be assessed for inclusion in this study.~      The primary outcome measure to be evaluated is the fracture-ORIF waiting period. Other~     measures to be evaluated are: peri-malleolar circumference; pain (as measured by NRS and~     analgesic use); duration of hospital stay; and complications such as poor wound healing,~     blisters, and the development of deep vein thrombosis.~   "
204494|NCT00884975|"~     Chronic obstructive pulmonary disease (COPD) exacerbation is a major cause of physician~     visits and hospital admissions associated with acute respiratory failure, causing increased~     morbidity and premature mortality and thus it can significantly affect Health Related Quality~     of Life (HRQoL).~      Previous studies suggested that patients who have experienced frequent exacerbation present~     worse HRQoL compared to patients with infrequent exacerbations. However, there are still~     questions regarding the relationship between HRQoL and exacerbations.~      In the present study the investigators will study a cohort of COPD patients over 6 years,~     they will document exacerbations, they will assess lung emphysema by computed tomography of~     the chest and they will evaluate health related quality of life in COPD patients.~      The investigators hypothesize that the extend of emphysema in COPD patients is positively~     correlated with worsen Health related quality of life (HRQoL).~   "
204495|NCT00884962|"~     This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients~     will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group~     will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments,~     respectively. All patients will receive treatment in a single lung under conscious sedation~     or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR~     treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be~     analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to~     be retreated at additional sites so that their total dose received is consistent with the~     effective dose. All study patients will receive standard medical therapy in addition to PLVR.~   "
204496|NCT00884949|"~     This multicenter, open-label study is designed to assess safety, dose-response using~     pharmacokinetic (PK) and pharmacodynamic (PD) measures, and clinical efficacy of BMN 110 in~     subjects between 5 and 18 years of age, diagnosed with Mucopolysaccharidosis IVA (MPS IVA).~   "
204497|NCT00884936|"~     This study is a blinded, prospective, single-center, clinical study conducted in Japanese~     female subjects between the ages of 20-75 years. This design uses skin biopsy samples from~     environmentally exposed areas and unexposed (control) areas within the same subjects to~     assess the gene expression profile from three different age groups.~   "
204498|NCT00884910|"~     The purpose of this study was to investigate the long-term feasibility of the new Provox Vega~     22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system~     (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.~   "
204510|NCT00884754|"~     Patients presenting for elective surgery requiring tracheal intubation will be randomized to~     one of two different endotracheal tube (ETT) stylets. The intubation will be done with a~     GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.~   "
204499|NCT00884897|"~     Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in~     patients with schizophrenia and these are not remediated by antipsychotic medications or~     psychosocial interventions. Social cognition is associated with functional outcome, an~     important step in striving for recovery in this population. The hormone and neurotransmitter,~     oxytocin, which has been associated with social bonding and trust has been shown to improve~     measures of some aspects of social cognition in humans. The study will assess the effect of~     acute administration of intranasal oxytocin on measures of social cognition and functioning~     as well as on emotional intelligence and symptoms.~      Study population: The study population will include patients with a DSM-IV diagnosis of~     schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6~     weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups).~      Experimental design and methods: After a one week lead in phase, participants will undergo 3~     weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their~     existing medication regimen. Outcome measures will be administered during the lead in phase,~     and at the end of the study drug administration phase (under the acute effect of OT). The~     primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)~     and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating~     from the domains of social cognition (emotion perception, attributional style, theory of mind~     and social perception), symptom rating and measures of social anxiety and quality of life.~     Side effects and symptoms will be measured weekly.~   "
204500|NCT00884884|"~     The current study investigates the effects of two potential alcohol treatment medications on~     drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin~     receptors with fewer limiting side effects seen with other atypical antipsychotics.~     Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise~     in reducing heavy drinking. Few studies have used two medications with such a diverse~     combination of actions to examine a potential synergistic effect on reducing alcohol~     consumption.~      The primary aims are to:~        1. determine if APZ and TPMT are each more effective than placebo, and the combination of~          APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol~          use in non-treatment seeking alcohol dependent subjects in a laboratory based alcohol~          self-administration experiment (ASAE)~        2. examine a hypothesized dose-response for three doses of APZ (0, 7.5 mg/d and 15 mg/d)~          along with three doses of TPMT (0, 100mg/d and 200mg/d)~        3. examine the putative mechanisms of action of APZ, TPMT alone and together on craving,~          subjective stimulation, candidate gene influences and other behavioral effects~          associated with alcohol consumption~        4. establish the safety of giving APZ and TPMT together. Non-treatment seeking, alcohol~          dependent Participants (N=216) will be recruited from the community and randomly~          assigned to one of the 9 cells. Subjects drinking and safety is monitored over a 5-week~          titration to their target dose, leading to an in-laboratory alcohol self administration~          session, during which clinical and behavioral effects are assessed during access to~          alcohol. A 1 month follow-up assesses adverse events and drinking.~   "
204501|NCT00884871|"~     The specific aim of this study is to evaluate the effect of surgically-induced weight~     reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor~     disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and~     pelvic organ prolapse in severely, morbidly and super-obese women using a prospective,~     observational study design.~   "
204502|NCT00884858|"~     Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in~     HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a~     decrease in CD4 cell count in patients with suppressed or low level viremia has been~     observed.~      Although the efficacy of current antiretroviral medications is well established, some~     antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any~     effect on immune reconstitution.~      Both T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an~     environment in which CD4 T cell count decrease in the setting of low or suppressed plasma~     viremia is likely to occur.~      Another fascinating hypothesis, which has still to be elucidated, is that reconstitution of~     the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This~     extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor~     5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1.~      With this in mind, the investigators would like to propose and design a pilot exploratory~     clinical trial involving a population of HIV-1-infected patients that rapidly reached a~     virologic suppression without a reconstitution of their immune system.~   "
204503|NCT00884845|"~     Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of~     PM02734 administered in combination with erlotinib to determine the safety and tolerability~     and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the~     combination of PM02734 and erlotinib, in patients with advanced malignant solid tumors.~   "
204504|NCT00884832|"~     Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic~     are doing a research study to assess the effects of a medication, clonidine, on fecal~     incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug~     Administration (FDA) for treating high blood pressure, but not for treating incontinence and~     rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence,~     increase rectal capacity and reduce rectal sensation to a greater extent than placebo in~     women.~   "
204505|NCT00884819|"~     This is a prospective randomized, double-blind placebo-controlled trial of 6 months' duration~     evaluating the effect of fenofibrate (200 mg/day) in females with polycystic ovary syndrome~     and mild hypertriglyceridemia. The investigators primary objective will be to determine~     whether fenofibrate will reduce hepatic adiposity as measured using MRI, and our secondary~     outcomes will be to delineate the impact of fenofibrate on biochemical or clinical parameters~     for insulin resistance, cardiovascular disease, and reproductive status.~   "
204506|NCT00884806|"~     The purpose of this study is to clinically evaluate solution-related corneal staining with an~     investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel~     contact lens wearers.~   "
204767|NCT00881374|"~     Primary Objective:~      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated~     dermic irritability) and allergic potential (sensibilization) of the product Dermacyd~     Infantile.~   "
204511|NCT00884741|"~     This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to~     compare how well they work with or without bevacizumab in treating patients with newly~     diagnosed glioblastoma or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells~     and help kill them. It is not yet known whether temozolomide and radiation therapy are more~     effective when given together with or without bevacizumab in treating glioblastoma or~     gliosarcoma.~   "
204512|NCT00884728|"~     The purpose of this study is to determine whether a coordinated regional approach to healthy~     skin programs in six remote Aboriginal communities can demonstrate, not only a reduction in~     the burden of scabies and streptococcal skin sores, but also broad health benefits, including~     primary prevention of some chronic diseases that occur at particularly high rates in~     Australian Aboriginal communities.~      The primary objectives of the Program are:~        -  Demonstrate a reduction in scabies and skin sores on a regional basis~        -  Demonstrate the broader public health effects of Healthy Skin Programs, particularly~          those relating to chronic diseases such as rheumatic fever and renal diseases~        -  Build on the existing Indigenous capacity by assisting in the development of new~          knowledge and skills to improve the health and well being of Indigenous communities~        -  Establish the feasibility of incorporating Healthy Skin Programs into existing health~          service delivery~   "
204513|NCT00884715|"~     Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment~     of the symptoms of carcinoid syndrome.~   "
204514|NCT00884702|"~     Background:~        -  The brain needs sleep to function normally, but the purpose of sleep is not understood.~          Brain activity decreases during sleep, so it may be that sleep is important to maintain,~          repair, or reorganize brain cells. In animals, the formation of brain proteins increases~          during sleep, and the same thing may happen in humans.~        -  There is also evidence that learning and memory are helped by sleep, and that the~          synthesis of proteins in the brain are involved.~      Objectives:~        -  To examine the formation of proteins in the brain while people are awake, deprived of~          sleep, and during sleep.~        -  To look at the formation of proteins in the brain while awake or asleep and following~          learning a task.~      Eligibility:~        -  Healthy volunteers between 18 and 28 years of age.~        -  Volunteers must not have psychiatric, neurologic, or sleep disorders or certain types of~          vision problems, and must be able to undergo imaging studies.~      Design:~        -  Study Part I (protein formation in waking, sleep deprivation, and sleep):~        -  Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior~          to admission.~        -  Participants will have physical and psychological examinations, along with a blood~          sample.~        -  After admission participants will have three positron emission tomography (PET) scans to~          study protein formation and one magnetic resonance imaging (MRI) scan over the course of~          two days.~        -  Participants may be asked to stay awake for as long as 20 hours and will be monitored~          throughout.~        -  Participants will be able to sleep overnight after they complete the required scans and~          monitoring, and will be discharged the following morning.~        -  Study Part II (protein formation in waking and sleep combined with a learning task):~        -  Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior~          to admission.~        -  Participants will have physical and psychological examinations, along with a blood~          sample.~        -  After admission participants may be asked to stay awake for as long as 20 hours and will~          be monitored throughout.~        -  The next morning, participants will be trained to perform a computerized visual~          discrimination task, and will be tested 8 hours later (after sleep or after remaining~          awake) on the visual discrimination task.~        -  Some participants may have PET and MRI scans as part of the study.~        -  Participants will be able to sleep overnight after they complete the required tests and~          scans, and will be discharged the following morning.~        -  Participants will receive financial compensation for their participation in these~          studies.~   "
204515|NCT00884689|"~     The purpose of this study is to describe the use of rescue medication and quality of life in~     adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to~     physician's prescription and the current summary of product characteristics - SPC) or treated~     with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.~   "
204516|NCT00884676|"~     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone when~     given together with sunitinib malate in treating patients with progressive advanced solid~     tumors.~   "
204517|NCT00884663|"~     The main aim of the present study is to compare candesartan with propranolol for migraine~     prophylaxis.~   "
204518|NCT00884650|"~     The purpose of this study is to determine which pain management strategy continuous analgesic~     pump or orally-should be used in the management of children with cerebral palsy.~   "
204519|NCT00884637|"~     The FORESEE HOME is used in the recent years to detect Age-related Macular Degeneration (AMD)~     lesions. The device is capable of differentiation as to stages of AMD and early detection of~     changes including choroidal neovascularization (CNV) The Foresee HOME demonstrates a high~     level of sensitivity and specificity as to the different stages of AMD including newly~     diagnosed or early detection of CNV.~      The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between~     the two methods will allow better understanding of both devices.~      The FORESEE HOME can use as an assessment tool for the progression and success of the~     treatment given to AMD lesions. Therefore, evaluation the size and the location of the~     treated lesions may serve as an additional tool.~   "
204520|NCT00884624|"~     The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect~     polyps and other pathologies in the colon.~   "
204521|NCT00884611|"~     This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being~     conducted at Stanford University Medical Center and the University of Colorado Barbara Davis~     Center. It is paid for by the Juvenile Diabetes Research Foundation.~      The purpose of doing this research study is to understand the best way to stop an insulin~     infusion pump from delivering insulin to prevent a subject from having hypoglycemia.~     Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to~     evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor~     communicating wirelessly with a bedside computer running an algorithm that temporarily~     suspends insulin delivery when hypoglycemia is predicted in a home setting.~   "
204522|NCT00884598|"~     RATIONALE: Cilengitide may stop the growth of brain metastases by blocking blood flow to the~     tumor. Radiation therapy uses high energy X-rays to kill tumor cells. Giving cilengitide~     together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of cilengitide when~     given together with whole-brain radiation therapy in treating patients with brain metastases~     from lung cancer.~   "
204536|NCT00884403|"~     Several large trials report gestational dating by last menstrual period (LMP) overestimates~     gestational age (GA) vs. ultrasound (US) by approximately one week. Previous studies examined~     only term pregnancies. The investigators hypothesize an opposite tendency in women seeking~     abortion. This is an observational study undertaken by chart review.~   "
204523|NCT00884585|"~     This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the~     treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The~     study consists of a double-masked phase, and open-labeled phase, and an open-labeled~     maintenance phase. For the first 3 months of the study, patients will receive either masked~     Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients~     may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients~     who are in remission, will be re-randomized to receive either open-labeled Cyclosporine~     0.010% eye drops four times daily or twice daily.~   "
204524|NCT00884559|"~     Whether teaching leadership with a short debriefing has a positive influence on the~     performance of cardiopulmonary resuscitation remains largely unknown. The investigators will~     assess the sustained efficacy of a short leadership debriefing compared to a technical~     debriefing in a high fidelity simulated cardiopulmonary resuscitation.~   "
204525|NCT00884546|"~     To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923~     administered alone, in combination with lenalidomide plus dexamethasone, or in combination~     with bortezomib in subjects with relapsed or refractory multiple myeloma.~   "
204526|NCT00884533|"~     This study is a randomised double blind, parallel group, and will evaluate the effects of~     repeat oral doses of RSG- XR for 21 days on the QTc interval compared to placebo in a~     population of healthy adult males and females.~   "
204527|NCT00884520|"~     Phase: Exploratory Study~      Objectives: To collect drug bio-distribution data, begin collection of baseline and~     tumor/background imaging data, acquire experience to improve study design and the conduct of~     future studies~      Design: Exploratory, open label, nonrandomized, multi-center study~      Duration: Three visits - one screening, one imaging, and one follow-up visit at 24 hours~     post-dose~      Procedures: Informed consent, collection of demographic information and medical history,~     physical examinations, vital signs, 12-lead ECGs, routine blood tests to assess major organ~     functions, complete blood counts and clinical chemistries for safety, blood sample for CA-IX~     assay, pre-dose and post-dose blood samples for metabolite analysis, dosing with~     [F-18]VM4-037, PET imaging scan, dosimetry estimation (normals), urine collections (normals),~     tumor immunohistochemistry with CA-IX biomarker, follow up to imaging to collect adverse~     events~      Subjects: Approximately sixteen (16) adult subjects including four (4) healthy volunteers and~     twelve (12) cancer subjects who have confirmed or highly suspected diagnosis of head & neck,~     lung, large solitary hepatic and renal cell cancer, as defined by protocol criteria~   "
204528|NCT00884507|"~     This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo~     added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a~     screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534~     1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated~     time on study treatment is 6 months, and the target sample size is 100-500 individuals.~   "
204529|NCT00884494|"~     Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines~     immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an~     individual's ability to respond to insulin. The purpose of this study is to determine if the~     decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin~     sensitivity.~   "
204530|NCT00884481|"~     The primary objective of this trial is to observe the Multiple Sclerosis (MS) related fatigue~     during treatment with Tysabri as measured by changes in the fatigue scale for motor and~     cognitive functions (FMSC) over the course of 12 months. The secondary objectives are: To~     investigate changes in fatigue, capacity for work, Health Related Quality of Life (HRQol),~     sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking,~     status of MS disease progression and amount of walking at different times points after~     initiation of Tysabri treatment in participants diagnosed with Relapsing-Remitting Multiple~     Sclerosis (RRMS). Changes in fatigue are measured at 3, 6 and 9 months, whereas changes in~     capacity for work, HRQoL, sleepiness, cognitive impairment, physical activity induced~     exhaustion, speed of walking, status of MS disease progression and amount of walking are~     measured at 6 and 12 months. To investigate correlation between fatigue and cognitive~     impairment, depression and physically activity induced exhaustion and status of MS disease~     progression in participants at baseline, 6 and 12 month of treatment with Tysabri and to~     document any changes in fatigue related medication.~   "
204531|NCT00884468|"~     This is an epidemiological non-interventional study assessing the prevalence of anxiety~     and/or depression disorders in patients suffering from Psoriatic Arthritis (PsA) in Spain.~   "
204532|NCT00884455|"~     This is a long-term follow-up banking protocol that collects medical information and tissue~     (blood, liver and lung) samples for future research; use of data and samples for research~     purposes is overseen by the Tissue Bank Advisory Committee; the purpose of the Bank is to~     further research on alpha-1 antitrypsin deficiency.~   "
204533|NCT00884442|"~     The present study will be performed to investigate and to compare the in-vivo performance of~     the two investigational products Gen-nifedipine extended release, (previously referred to as~     Gen-Nifedipine XL (Genpharm ULC, Canada)) and Nifedipine(Bayer Healthcare AG manufactured as~     Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) by comparing their pharmacokinetic~     parameters after oral single dose administrations in the fasted and fed state.~   "
204534|NCT00884429|"~     The purpose of this study is to verify the effectiveness of chest physiotherapy (actual~     versus conventional) on respiratory distress in infants with acute viral bronchiolitis.~   "
204535|NCT00884416|"~     This is a phase I study to evaluate the safety and tolerability of Sorafenib in combination~     with Temodar and radiation therapy in patients with newly diagnosed high grade glioma~     (glioblastoma, gliosarcoma, anaplastic astrocytoma and anaplastic oligodendroglioma or~     oligoastrocytoma). The mechanism of action of sorafenib, an oral multikinase inhibitor, makes~     it an interesting drug to investigate in the treatment of patients with high grade glioma as~     this agent has anti-angiogenic activity and inhibits other pathways such as Ras,~     Platelet-derived growth factor (PDGF) and fms-like tyrosine kinase receptor-3 (Flt-3), which~     are potential targets against gliomas.~   "
204537|NCT00884390|"~     The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and~     other Factor VIII products.~   "
204540|NCT00884351|"~     Background:~        -  An absence seizure is a type of seizure that usually begins in childhood and goes away~          by early adulthood. Scientists do not yet know where absence seizures begin in the~          brain. Some evidence suggests that these seizures begin in the thalamus, a structure~          deep in the brain, but other studies suggest that they begin in the frontal cortex, at~          the front part of the brain.~        -  Magnetoencephalography is a type of brain scanning procedure that is useful in~          determining information about what happens to the brain during epileptic seizures.~          Understanding where absence seizures come from may help doctors find new treatments for~          them.~      Objectives:~        -  To gain a better understanding of which parts of the brain are affected in absence~          seizures.~      Eligibility:~        -  Patients 7 to 35 years of age who have been diagnosed with absence seizures.~      Design:~        -  Procedures are for research purposes only, not to diagnose or treat a particular medical~          condition.~        -  Two outpatient visits to the National Institutes of Health Clinical Center: evaluation~          and scanning.~        -  Researchers will evaluate potential participants with a medical history, physical~          examination, and electroencephalography (EEG). These tests will be performed under~          another protocol, 01-N-0139.~        -  Patients will undergo magnetoencephalography (MEG) and magnetic resonance imaging (MRI)~          of the brain. The study procedures will be performed one time; however, an MEG or MRI~          scan may need to be repeated for technical reasons. Researchers will not do more than~          two MEG or MRI scans.~        -  The MEG will record very small magnetic field changes produced by the activity of the~          brain. An EEG will be recorded at the same time as the MEG.~        -  The MRI will use a magnetic field to take pictures of the inside of the brain.~        -  The MEG will take 3 hours to complete (2 hours for preparation, 1 hour in the scanner).~          The MRI will take approximately 1 hour.~   "
204541|NCT00884338|"~     The trial will evaluate the effects of an exercise program on the physical and cognitive~     performance of patients with hematological neoplastic diseases after high dose chemotherapy~     with stem cell support.~   "
204542|NCT00884325|"~     It is historically well known that the management of pruritus in atopic dermatitis is very~     difficult. Most of the patients are not controlled with traditional antihistamines such as~     Clarinex, Claritin, and Allegra. It will be a welcome addition to our treatment armamentarium~     if a drug such as Xyzal can control pruritus associated with atopic dermatitis.~   "
204543|NCT00884312|"~     This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and~     efficacy of long-term or continuing carfilzomib therapy for patients who previously completed~     a primary carfilzomib treatment study.~   "
204544|NCT00884299|"~     Chronic obstructive pulmonary disease (COPD) is characterized by increased oxidative stress~     which aggravates airway and systemic inflammation. Previous studies suggested that dietary~     factors such as ample consumption of antioxidants might have beneficial effects in lung~     function in COPD patients.~      The investigators' primary aim is therefore to investigate prospectively whether a~     nutritional intervention consisted of diet rich in antioxidants such as fresh fruits and~     vegetables, would significantly affect lung function decline in COPD patients compared to a~     free diet.~      Methods: This is a 3-year prospective study, incorporating a run-in period of six months and~     outpatient clinic visits, scheduled every 6 months. Consecutive sampling was used to recruit~     120 patients with COPD. At baseline and at each visit all patients were evaluated for~     respiratory symptoms, dietary habits, medication used and pulmonary function. Patients will~     be randomized either to a diet based on increased consumption of foods containing~     antioxidants (fresh fruits and vegetables), intervention group (IG) or, to a free diet,~     control group (CG).~      The investigators hypothesize that the results from the study will suggest that a diet rich~     in antioxidants may be associated with improvement in lung function in COPD patients. In this~     respect dietary interventions should be considered in the management of COPD.~   "
204545|NCT00884286|"~     This is a multicenter study to assess the anti-tumour activity,to investigate the safety~     profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour~     weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.~   "
204546|NCT00884273|"~     This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the~     current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6~     mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix~     (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in~     prostate volume.~      The hypothesis was that degarelix could decrease prostate size at least as effectively as the~     combination of a GnRH agonist with an anti-androgen for flare protection.~   "
204547|NCT00884260|"~     The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG~     (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for~     use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be~     performed.~   "
204548|NCT00884247|"~     The study aims to evaluate if a GERD treatment programme, in accordance with current regional~     recommendations, in a company health care setting, has an impact on health related quality of~     life (HRQoL), symptoms, and productivity in GERD patients.~   "
204549|NCT00884234|"~     The purpose of this study is to determine the safety and efficacy of 2 sequential doses of~     RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.~   "
204550|NCT00884221|"~     The main purpose of this clinical research trial was to compare the ongoing pregnancy rate~     between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant~     follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH)~     antagonist was used for prevention of premature luteinizing hormone (LH) surge and where a~     single embryo was transferred at the blastocyst stage.~   "
204551|NCT00884208|"~     The purpose of this study is to assess the diagnostic efficacy of the Tinetti Assessment,~     Timed up and Go test (TUG) and Gait Speed on predicting fall risk in adults 65 years of age~     or greater who are community ambulators.~   "
204552|NCT00884195|"~     This is a pilot study to evaluate the effect of keeping a 'gratitude journal' on the outcome~     of a weight loss program. All the subjects will be enrolled in the Lifesteps weight~     management program. The experimental group will maintain a gratitude journal and the control~     group will maintain a 'neutral' journal.~   "
204553|NCT00884182|"~     This study is part of an effort to develop an effective vaccination program in children in~     the event of a pandemic.~      Study objectives:~        -  To describe the safety profiles in the periods following each vaccination in subjects~          receiving different vaccination schedule.~        -  To describe the immune response after each vaccination in subjects receiving study~          vaccine.~   "
204554|NCT00884169|"~     This study is to investigate the efficacy and safety of M518101 in male and female plaque~     psoriasis patients with refractory plaques.~   "
204588|NCT00883714|"~     The study will evaluate the effects of a structured endurance exercise program on the~     physical performance, the mood and the complications of patients with hematological~     malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood~     stem cell transplantation.~   "
204555|NCT00884143|"~     There are different types of hormonal therapy medicines for the treatment of~     hormone-receptor-positive breast cancer. The purpose of this study is to determine the~     evolution of two types of hormonal treatment (the drug called tamoxifen and a group of~     medicines called aromatase inhibitors) during two time periods of 12 months each, in years~     2006 and 2008, in the northeast Italian regions. The study will include post-menopausal women~     who have initiated hormonal therapy medicines in 2006. The study will also verify the rate of~     implementation of the updated national and international recommendations for the use of~     adjuvant hormonal therapy in the hormone-receptor-positive breast cancer.~   "
204556|NCT00884130|"~     Hypothesis: The total costs of laparoscopic colorectal surgery are less than those of open~     surgery.~      Secondary hypothesis: Patients quality of life is higher following laparoscopic surgery, as~     compared to open colorectal surgery.~      Research objectives:~        1. To estimate the cost implications and clinical benefits of incorporating laparoscopic~          colorectal surgery into routine clinical practice.~        2. To examine whether the increased operative costs of laparoscopic surgery are compensated~          for by a faster recovery, shorter duration of hospital stay, and a reduction in late~          complications, as compared to open surgery.~        3. To investigate whether there are differences in quality of life following laparoscopic~          colorectal surgery as compared to open surgery.~      Lay summary:~      Patients needing an operation for a bowel problem have traditionally had an open operation~     with an incision on the abdomen, and this is the type of operation that is currently~     performed in the majority of cases in the United Kingdom today (over 90%). Laparoscopic (or~     keyhole) surgery has been introduced into bowel surgery, but is currently not widely~     performed. This is because thus far there have been no clear-cut benefits demonstrated with~     this technique and the perceived costs are higher than an open operation. The investigators~     aim to evaluate both of these issues.~   "
204557|NCT00884117|"~     This study will assist in the early detection of influenza resistant to antivirals and will~     monitor the clinical outcome of adults and children infected with influenza according to~     subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a~     rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants~     will be clinically managed according to local guidelines and the decision to treat/not treat~     will be at the discretion of the Investigator.~   "
204558|NCT00884104|"~     The purpose of this study is to evaluate the rate of add-on solifenacin treatment and its~     persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4~     weeks.~   "
204559|NCT00884091|"~     The purpose of the study is to standardize a meal test to facilitate future studies of the~     postprandial glucagons-like peptide 1 (GLP-1) response in Chinese subjects. Eighteen healthy~     Chinese subjects, aged between 20-65 years old, without history of diabetes, will be~     recruited for the study. Each subject will receive two mixed meal tests for postprandial~     GLP-1 excursion at random order: 60 % carbohydrate (CHO)/20 % fat vs. 50 % CHO/30 % fat. The~     postprandial glucose, insulin, glucagon and other related hormones responses will also be~     measured. Through the study, we hope to build up a platform for the study of the postprandial~     GLP-1 response and insulin secretion.~   "
204560|NCT00884078|"~     Aim of the study is to adapt and develop a culturally appropriate psychological intervention~     and to pilot test it's feasibility, and acceptability for the adult South Asian females~     presenting to general hospital emergency department following self-harm. Primary hypothesis~     for the study is to determine whether a brief psychological intervention compared with~     treatment as usual for self-harm results in decreased hopelessness and suicidal ideation.~     Further to this to collect necessary information on recruitment, the assessment instruments,~     effect size, the optimal delivery and acceptability of the intervention in preparation for a~     definitive RCT using repetition of self harm and cost effectiveness as the primary outcome~     measures.~   "
204561|NCT00884065|"~     While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its~     effectiveness has not been tested in clinical trials. The investigators hypothesized that the~     use of DF in patients suffering from painful shoulder would increase the active mobility and~     reduce the pain during movement. To test the hypothesis a double blind (patient and~     investigator) randomized clinical trial was carried out in two public Primary Health Care~     Centres. Fifty patients were randomly allocated to two groups: the intervention group, who~     received a real DF session, and the control group, who received a placebo DF session.~   "
204562|NCT00884052|"~     The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of~     Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.~   "
204563|NCT00884039|"~     This study will investigate the use of anecortave acetate injection to reduce intraocular~     pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated~     pressure control problems. Alternative methods of IOP control have been shown to entail~     serious risks. For example, reduction of topical steroids increases the risk of graft~     rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft~     failure. This study is designed to have sufficient power to detect whether a single injection~     can induce a clinically significant IOP reduction.~   "
204564|NCT00884026|"~     A fall in blood pressure (hypotension) occurs in one third of spinal anesthetics administered~     to pregnant patients undergoing cesarean delivery. However, predicting which patients will~     experience hypotension following spinal anesthesia has proven difficult. Pulse wave analysis~     is a repeatable and reproducible method for investigation of cardiovascular function. A~     device called a SphygmacorTM can be used to measure pulse. The pulse measurement is called~     the Augmentation Index (AIx). AIx has been useful in detecting risks associated with blood~     pressure changes after complex surgery in patients with heart and blood vessel disease. In~     this study the investigators wish to see if it is possible to predict if a subject will~     experience hypotension based on her AIx measurement preoperatively.~   "
204565|NCT00884013|"~     Do monetary incentives in small independent primary care practices improve the delivery of~     preventive services as recommended by U.S. Preventive Services Task Force (USPSTF) guidelines~     for cardiovascular health?~   "
204601|NCT00883545|"~     The purpose of this study is to determine whether women who are offered screening colonoscopy~     will be more likely to schedule and complete this procedure if they are given the option of a~     woman endoscopist.~   "
204566|NCT00884000|"~     This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone~     deficiency in children. The children will be treated for 1 year. Half of the patients will be~     treated with Genotropin and half with Zomacton. During this time they will be dosed every day~     by themselves or their parents at home in the evening. There will be 138 patients in the~     trial from age 3 to age 11. The patients cannot have been treated before with growth hormone~     and the patients must have a proven growth hormone deficiency, this will be shown by a~     specific test that will be performed before the trial in the local clinic and once during the~     trial. During the time of the treatment the patients will come to visit the clinic every 3~     months. At these visits their heights will be measured, blood samples will be taken, physical~     examinations will be performed and questions about their health will be asked. At 2 times in~     the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial~     the patients will stop the treatment and continue on one of the marketed products available~     to treat growth hormone deficiency.~   "
204567|NCT00883987|"~     Eighty percent of Canadians experience low back pain (LBP) at some point in their life~     (Waddell, 1987), with a point prevalence of up to 30 percent (O'Sullivan, 2005; Waddell,~     1987). Low back pain has severe economic ramifications. Most incidents of low back pain occur~     during the prime working years of life, with an estimated cost to the economy at $14,744~     Canadian dollars per person per year (Health Canada, 1998). Indirect costs in the form of~     long-term disability were highest for disorders of arthritis and chronic back pain (Health~     Canada, 1998). It has been estimated that 12 percent of patients will experience disability~     within one year after their first episode of low back pain (Banner, 2006). Evidence based~     diagnosis and treatment is important for desirable outcomes.~      The investigators predict that there will be changes in A) trunk muscle electromyographic~     patterns and in temporo-spatial gait patterns following osteopathic treatment.~   "
204568|NCT00883974|"~     Immediately following birth, preterm infants face a period of stressful environmental inputs,~     which may have negative consequences on early brain development and subsequent~     neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in~     reducing stressful experiences early in life. The investigators hypothesized that this~     intervention would insulate preterm infants from the harmful effects of acute and chronic~     stress, which in turn would result in enhanced brain development. The primary aim of the~     current study was to investigate if this intervention was associated with improved brain~     development measured by magnetic resonance imaging (MRI) at term-equivalent age. A secondary~     aim was to assess some possible short-term medical benefits.~   "
204569|NCT00883961|"~     The study evaluates the effects of a supervised exercise program on the physical performance,~     the mood and the complications of therapy in patients undergoing a high-dose chemotherapy~     followed by an autologous peripheral blood stem cell transplantation.~   "
204570|NCT00883948|"~     Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions~     that occur when there is severe inflammation and increased fluids in both lungs, making it~     difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS~     often includes the use of a breathing machine, or ventilator, until the person is able to~     breathe without assistance. Initiating proper nutrition through a feeding tube early in a~     person's hospital stay may help to improve recovery, but the optimal timing, composition, and~     amount of feeding treatments remain unknown. This study will evaluate whether early or~     delayed full-calorie feeding through a feeding tube is more effective in reducing recovery~     time and increasing survival rates in people with ALI/ARDS.~   "
204571|NCT00883935|"~     The purpose of this study is to compare the amount of GSK1349572 (study drug) in the blood~     when given with and without atazanavir/ritonavir or atazanavir and to compare the blood~     levels of atazanavir when given with GSK1349572 to historical data for atazanavir.~   "
204572|NCT00883922|"~     Children (ages 0-12) that have heart surgery are often at a high risk of developing~     complications and have to be continuously monitored. Part of the routine care at UCLA~     includes using a monitor (continuous central venous oxygen saturation-ScvO2) to measure the~     amount of oxygen saturation in the tissues (indirectly) during surgery and in the intensive~     care unit. However, there is not much data on the use and effectiveness of this monitor in~     comparison to other monitors used for children.~      The purpose of this study is to further evaluate the effectiveness of the continuous central~     venous oxygen saturation (ScvO2) monitor in children and compare it with other monitors~     during a heart surgery. This is an observational study and the patients will not undergo any~     research specific procedures in the operating room (OR). The investigators will observe and~     record de-identified information, such as vital signs (heart rate, blood pressure, etc.), to~     evaluate the importance of the monitor. This study will also look at the demographics (age,~     gender, diagnosis, etc.) and treatments (type of surgery) received children undergoing heart~     surgery to improve quality of care. The investigators will also observe the same parameters~     in the ICU. The investigators hypothesized that low central venous saturations are associated~     with worse clinical outcomes.~   "
204573|NCT00883909|"~     ARI103094 is a follow-up study in adult male subjects who have received investigational~     product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of~     prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel~     Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily~     for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. There are 2 parts to~     this REDUCE Follow-Up Study, Part A and Part B:~        -  REDUCE Follow-Up Study, Part A, is a 2 year observational study which will follow~          eligible subjects for 2 years after completion of the 4 Contact in the REDUCE study.~          Eligible subjects for Part A, the 2 Year Observational Study fall into 3 groups as~          follows: (1) REDUCE subjects who completed treatment with investigational product~          (dutasteride or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE~          subjects who developed prostate cancer, were withdrawn from investigational product and~          participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit~          10P] or (3) REDUCE subjects who were withdrawn from investigational product and~          participated in observational phone follow up until the REDUCE 4 Year phone call after~          withdrawing from IP (expected Visit 10). The objective of this observational study for~          eligible REDUCE subjects is to collect and summarize data on prostate cancer (the~          incidence of newly diagnosed prostate cancers and changes in prostate cancer diagnosed~          during the REDUCE study) and serious adverse events (SAEs) for 2 years beyond the~          prospectively planned 4 year double blind, placebo-controlled study, REDUCE.~        -  REDUCE Follow-Up Study, Part B, is for collection of cancer positive prostate biopsy~          tissue blocks/slides from subjects who were diagnosed with prostate cancer in the REDUCE~          study.~   "
204574|NCT00883896|"~     The primary objective of this study is to assess the safety and efficacy of different dose~     regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with~     active rheumatoid arthritis who are taking methotrexate.~   "
204575|NCT00883883|"~     To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed~     conditions.~   "
204576|NCT00883870|"~     This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in~     critical limb ischemia.~   "
204577|NCT00883857|"~     The purpose of this study is to evaluate a new monitor that measures cardiac output (amount~     of blood pumped by the heart). The system that is being tested in this study, called~     Endotracheal Cardiac Output Monitor (ECOM), uses electricity (impedance cardiography) to~     measure cardiac output and is not harmful to the patient.~      This study will test the accuracy and efficacy of the ECOM system in anesthetized and sedated~     patients who, in the normal course of clinical care in the OR or ICU, are having cardiac~     output measured. The investigators propose that unlike the standard system for cardiac output~     measurement, the ConMed ECOM System should result in a simplified, inexpensive, continuous,~     less-invasive, and accurate method of measuring cardiac output. Such a technique could allow~     the rapid diagnosis of instability in the cardiovascular system for critically ill patients.~   "
204578|NCT00883844|"~     Treatment with a nucleoside analogue and subsequent viral decline has shown to partially~     restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies~     investigating whether the effect of lowering viral load with nucleoside analogue therapy~     prior to the initiation of peginterferon results in higher sustained off-treatment responses~     showed contradictory findings.~      The aim of this study is to investigate sustained off-treatment response to peginterferon~     alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide~     analogues, thereby lowering viral load~   "
204579|NCT00883831|"~     Purpose:~      Hemodialysis-dependent patients with an end-stage renal disease (ESRD) suffer from a number~     of distressing symptoms, such as pain, poor mental health, fatigue, sleep disturbance and~     pruritus. These negatively influence health-related quality of life in ESRD patients, and~     some of them result in increased mortality and hospitalization. Acupuncture is a widely~     employed treatment on several chronic disease or condition. Adjunctive use of acupuncture~     with conventional treatment could be a possible therapeutic option to establish an optimal~     care for ESRD patients who experiences co-morbid conditions or complications of hemodialysis.~     Due to its non-pharmacologic feature, the effects of acupuncture without involving altered~     pharmacokinetics and drug-interactions in hemodialysis patients, might be another strong~     point compared to other pharmacological interventions. However, little information is~     available for the effects and the safety of acupuncture for symptomatic care of hemodialysis~     patients.~      Thus, the investigators propose whether acupuncture could be a effective and safe therapeutic~     modality for a number of patient-reported symptoms in hemodialysis-dependent patients with~     ESRD.~   "
204580|NCT00883818|"~     The objective of this prospective study is to determine the incidence of mycoplasma in women~     with overactive bladder (OAB) symptoms and whether antibiotic therapy targeting these~     organisms is effective.~   "
204581|NCT00883805|"~     This is a pilot study to compare systemic concentrations of cobalt and chromium in patients~     that have previously undergone total hip arthroplasties with ceramic on metal and metal on~     metal bearing surfaces.~   "
204582|NCT00883792|"~     Colorectal cancer (CRC) is a major burden in western countries. The disease develops from~     precursor lesions during a long time-interval. Colonoscopy can detect and remove CRC~     precursor lesions and may thus be effective for CRC prevention. Many national and~     international health organisations demand evidence from randomised trials to reduce incidence~     or mortality of the target disease before advocating population-wide cancer screening.~     However, while colonoscopy screening for the prevention of colorectal cancer is established~     in the United States and several European countries, no randomised trials exist to quantify~     the possible benefit of colonoscopy screening. NordICC is a randomised trial investigating~     the effect of colonoscopy on CRC incidence and mortality.~      NordICC is a multicentre, randomised trial in Nordic countries, the Netherlands and Poland. A~     minimum of 66 000 individuals, age 55-64 years, are drawn randomly from the population~     registries in the participating countries. 22 000 are invited for once-only colonoscopy (2:1~     randomisation). Expected work-load with 50% compliance will be 11,000 colonoscopies. At the~     screening examination, all detected lesions are biopsied and removed whenever possible. The~     remaining 44 000 individuals (control group) are not offered any screening examination (care~     as usual).The primary study aims are CRC incidence and CRC mortality after 15 years of~     follow-up, with an interim analysis after 10 years of follow-up. In an intention-to-treat~     approach, a risk reduction of CRC mortality of 25% in the colonoscopy screening group~     compared to the control group is expected after 10 years follow-up, estimating 50% compliance~     in the screening group.~   "
204583|NCT00883779|"~     This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or~     placebo, plus platinum-based therapy, as first line treatment in patients with advanced or~     recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine~     (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1,~     followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a~     total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on~     study treatment is until disease progression, and the target sample size is 100-500~     individuals.~   "
204584|NCT00883766|"~     The aim of this study is to compare two different IVF-stimulation protocols in patients~     affected by PCOS: the use of a Gonadotropin-releasing hormone (GnRH) - antagonist starting on~     day 1 of controlled ovarian hyperstimulation (COH) versus a standard long agonist protocol;~     in order to assess whether it affects the number and quality of Metaphase II (MII) oocytes~     while reducing the risk of hyperstimulation. Since PCOS patients are also likely to be~     insulin resistant we also aim to evaluate how metformin affects tha IVF stimulation outcome.~   "
204585|NCT00883753|"~     This study was an extension to study MA21573 [NCT00750880], which was an open label single~     arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or~     combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in~     patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24~     week core study, and had at least a moderate European League Against Rheumatism (EULAR)~     response, were eligible to enter this long-term extension study, and received tocilizumab 8~     mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years,~     and the target sample size was > 500 individuals.~   "
204586|NCT00883740|"~     The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in~     subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)~   "
204587|NCT00883727|"~     This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells~     in patients with myocardial infarction.~   "
204589|NCT00883701|"~     COPD exacerbations are characterized by an excessive accumulation and activation of~     inflammatory cells in the airways. It is not known whether this phenomenon represents a risk~     for for lung damage via the release in the extracellular environment of potent cytolitic~     cellular granular contents such as granzymes and perforin.~      The investigators assess the intracellular expression of granzymes and perforin in~     neutrophils and large granular lymphocytes (LGL) at the onset of exacerbations compared to~     stable disease.~      The investigators hypothesize that a greater release of intracellular perforin and granzymes~     from neutrophils and LGL into the extracellular environment occur at exacerbations compared~     to stable condition and that these changes are more pronounced in COPD patients than in~     subjects without COPD who undergo respiratory infection.~   "
204590|NCT00883688|"~     The goal of this clinical research study is to learn if the combination of Avastin~     (bevacizumab) and Tykerb (lapatinib) can help to control ependymoma in pediatric patients.~     The safety of this drug combination will also be studied.~   "
204591|NCT00883675|"~     The purpose of this study is to determine whether it is safe to treat lung cancer patients~     who have undergone an attempt at curative resection with the combination of docetaxel and~     carboplatin.~   "
204592|NCT00883662|"~     Mirena is used for long-term in Kazakhstan, and in our observational program we would like to~     study patients distribution per indications of Mirena, and also patient compliance within a~     year after Mirena insertion. For patients with all approved indications for Mirena use:~     contraception, treatment of menorrhagia and protection from endometrial hyperplasia during~     estrogen replacement therapy~   "
204593|NCT00883649|"~     The purpose of this study is to determine the effectiveness of a nutritional supplement in~     post-menopausal women age 40 or older with moderate to severe dry eyes. This study is being~     conducted to determine if signs and symptoms of dry eye will improve with the use of this~     nutritional supplement.~   "
204594|NCT00883636|"~     The objective of this study is as follows:~        -  Perform genetic analysis to define the prevalence of each of the known gene mutations in~          an unselected cohort of patients with focal segmental glomerulosclerosis (FSGS)~        -  Perform a comprehensive assessment of cardiovascular status to determine the incidence~          of any cardiac abnormalities in patients with FSGS~        -  Determine if patients with mutations in specific proteins are more likely to have~          cardiovascular abnormalities~        -  Initiate long-term follow up in all patients to determine whether cardiac prognosis is~          related to any specific genetic abnormality~   "
204595|NCT00883623|"~     The treatment with oral melphalan and prednisone has been recommended as standard treatment~     of AL amyloidosis but the results are rather disappointing. Another therapeutic option is~     pulsed high-dose dexamethasone + melphalan (Mel-Dex) with more encouraging results regarding~     the achievement of a faster disease response and higher rates of haematological remission. In~     the last 5 - 10 years, promising treatment outcomes after therapy with high-dose melphalan~     and autologous stem cell support have been reported by several groups but only highly~     selected patients are eligible for this treatment. Lenalidomide has been shown to be~     effective in phase II and III trials in MM patients. Because of the relationship to MM,~     Lenalidomide is a promising therapeutic option also for patients with AL amyloidosis. The~     addition of Lenalidomide to Mel-Dex could improve rate of complete response (CR) and organ~     response in patients not eligible for or refused high-dose chemotherapy.~   "
204596|NCT00883610|"~     The purpose of this study is to learn what effect rapid atrial pacing (in patients with dual~     chamber pacemakers) will have on the electrocardiogram including the QT Interval. The~     investigators are also interested in the differences caused by genes.~   "
204597|NCT00883597|"~     Sepsis is the most frequent cause of death in critically ill patients in non-coronary care~     Intensive Care Units in the developed world. Microcirculatory disturbances are central to the~     development of the disorder, leading to organ dysfunction, multi-organ failure and fatal~     outcome.~      In particular the intestinal microcirculation is impaired early in the course of the disease.~     This may result in a breakdown of the gut barrier function with translocation of bacteria and~     their toxins into the systemic circulation, thus sustaining a gut derived septic state.~     Therefore, the impaired intestinal microcirculation has been suggested to act as the motor~     of multiple organ failure in sepsis.~      The aim of the project is to evaluate a new diagnostic tool and the impact of Activated~     Protein C administration on the intestinal microcirculation in patients with severe sepsis~     and compare the findings with septic patients who are not candidates for APC therapy and~     healthy patients post bowel surgery using an innovative diagnostic tool (side stream~     dark-field imaging, SDF).~   "
204598|NCT00883584|"~     COPD is a lung disease in which the lung is damaged, making it hard to breathe. In COPD, the~     airways/tubes that carry air in and out of the lungs are partly obstructed, making it~     difficult to get air in and out. COPD gets gradually worse over time. At the moment there is~     no cure for COPD. The best way to slow the disease is to stop smoking. Current medications~     are used to alleviate shortness of breath and cough, and to treat infections of the lungs~     that can worsen COPD.~      Institute of Medicinal Molecular Design, Inc. (IMMD), a Japanese Drug Discovery Company is~     developing a compound code named IMD-1041. IMD-1041 is an investigational drug, meaning it is~     not yet on the market. It is an IKKb inhibitor developed for the treatment of COPD. Unlike~     most other medications used for COPD currently, IMD-1041 is in capsule form and needs to be~     taken twice a day. It is also unlike all other drugs in use because it treats the underlying~     cause of the symptoms.~      The purpose of this study is to see if IMD-1041 has the ability to reduce inflammatory~     derived symptoms and airway remodelling (changes) by looking at certain changes in chemical~     levels in the blood and sputum (phlegm).~   "
204599|NCT00883571|"~     This prospective randomized study included 60 consecutive patients suffering from anal~     stenosis in the period from April 2002 to December 2008. They admitted to colorectal surgery~     unit, Mansoura university hospital, Egypt. According to the classification proposed by Milson~     and Mazier(5), all patients had moderate to severe anal stenosis. There were 43 males and 17~     female with a mean age 34 + 5.2 years ranging from 18 up to 63 years.~   "
204600|NCT00883558|"~     Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of~     diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid~     to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined~     with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be~     compared to insulin lispro with respect to absorption and action of insulin.~   "
204602|NCT00883532|"~     Pulmonary inflammation plays an important role in the early development of CLD. Postnatal~     glucocorticoids have been shown effective in the prevention or treatment of CLD with various~     success. However, systemic glucocorticoid therapy often associated with various short term~     and long term complications. Therefore, modification of the therapeutic regimen is needed.~     Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially~     unsuccessful, most likely due to small airways that the inhaled steroid reaching to the~     peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the~     airway has also shown to be ineffective, possibly due to poor distribution of steroid in the~     lungs.~      The investigators hypothesize that intratracheal instillation of budesonide, a strong~     tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to~     the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The~     result of our pilot study (Pediatrics, 2008) indicated this high possibility.~   "
204603|NCT00883519|"~     The primary aim of this study is to examine whether adolescent depression and the family~     context in which it develops is best treated using an individual adolescent intervention or~     an intervention that includes both the adolescent and the parents. This will be accomplished~     by conducting a randomized controlled pilot study of Interpersonal Psychotherapy for~     Depressed Adolescents (IPT-A) in comparison to Interpersonal Psychotherapy for Depressed~     Adolescents and Parents (IPT-AP).~   "
204604|NCT00883506|"~     To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet under Fasting and~     Fed.~   "
204605|NCT00883493|"~     The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with~     quetiapine fumarate in combination with lithium in the treatment of a major depressive~     episode in patients with bipolar disorder.~   "
204606|NCT00883480|"~     This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung~     adenocarcinoma.~   "
204607|NCT00883467|"~     Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to~     show the effects of short and long time ischemic preconditioning (both sequences 3 x 5~     minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional~     MRI. Ischemia is produces by cuff inflation to a suprasystolic pressure on one tight. Signal~     is acquired from calf muscles.~      A cross-over design of 4 to 8 study periods is used, 4 different study days with 2 different~     MR measurement methods (BOLD imaging and high energy phosphates) are planned.~   "
204608|NCT00883454|"~     Estimation of functional liver reserve in patients with hepatocellular carcinoma (HCC) in~     cirrhosis is of paramount importance to properly select candidates for surgical resection.~     Together with the value of bilirubin, the presence/absence of ascites and esophageal varices,~     and the rate of residual liver volume, which are our current parameters to measure functional~     liver reserve, the investigators sought to investigate the value of preoperative~     cholinesterases (CHE) in predict postoperative adverse outcome after hepatic resection for~     HCC.~   "
204609|NCT00883441|"~     This project will provide new insights concerning how to reduce dengue transmission by means~     of cost-effective and sustainable implementation strategies of vector control methods.~      The research will assess key strategies which deliver new vector control tools with respect~     to their cost-effectiveness, acceptability and sustainability in contrasting environments.~   "
204610|NCT00883428|"~     The purpose of this study is to determine the prevalence of low back and pelvic pain in~     Spanish pregnant women. The results should allow for the identification of factors associated~     with a greater risk of having it during pregnancy. Once risk factors are identified, other~     studies can assess the effectiveness of measures to reduce this pain.~   "
204611|NCT00883415|"~     This study examines patients with chronic kidney disease-related anemia and measures changes~     in the metabolism of the heart using FDG/PET scanning, before and 6 months after their~     health-care provider has initiated anemia management therapy with the FDA-approved drug~     darbepoetin alfa (Aranesp), which is approved for chronic kidney disease-related anemia. The~     investigators hypothesize that the heart has abnormal metabolism with the anemia of chronic~     kidney disease but this improves after correction of this anemia with darbepoetin alfa.~   "
204612|NCT00883402|"~     The trial randomise patients with asymptomatic carotid artery narrowing in whom prompt~     physical intervention is thought to be needed, but there there is still substantial~     uncertainty shared by patient and doctor about whether surgery or stenting is the more~     appropriate choice.~      The study is looking at immediate risks (within one month)and at long term benefits~   "
204613|NCT00883389|"~     This is a pilot observational study to evaluate subjects with chronic kidney disease~     acceptance of an alert device linked to an informational website intended to increase~     recognition of chronic kidney disease, and to guide patients and providers to the safe~     delivery of care required for this disease. Primary device was a bracelet with the~     alternative of a key fob with same information supplied when requested. Patients usage of the~     device was evaluated by survey with Likert scale as to whether the device is 0 = not useful,~     1 = somewhat useful, 2 = extremely useful~   "
204614|NCT00883376|"~     Introduction: Obstructive sleep apnea syndrome (OSAS) became an important and prevalent~     illness in recent years. The population occidental becomes fat each time, and this symptom is~     associated the biggest risk for the OSAS. Snore presence is extremely associated with OSAS.~     Snoring is present in about 90 - 95% of the patients with OSAS.~      Objectives: Evaluate the influence in the Stanford classification as predictor factor of~     gravity of the OSAS.~      Materials and Methods: They evaluated and classified 107 patients, Classification of~     Mallampati, Friedman, Classification of Stanford and how much the gravity of the OSAS for the~     AIH.~   "
204615|NCT00883363|"~     Preconditioning in patients treated for elective abdominal aneurysm showed that the rate of~     perioperative myocardial infarction could be reduced by 80 %(ARR from 27% to 5%).~     Precondition where performed by 10 minutes of clamping of each iliac arteries before clamping~     the abdominal aorta. Human studies in cardiac patients have shown promising results with~     precondition. Instead of clamping arteries they have all performed the procedure by inflating~     a blood pressure cuff above arterial pressure on a arm.~      The investigators want to investigate if preconditioning induced by a blood pressure cuff on~     a arm can reduce the perioperative rate of myocardial infarction in patients open operated~     for ruptured abdominal aortic aneurysm.~   "
204616|NCT00883350|"~     A large proportion of the adult population in the United States qualifies for weight loss~     treatment based on the NIH treatment recommendations, but traditional clinic-based weight~     loss treatments have a number of limitations. For example, access to healthcare facilities is~     limited among people living in rural communities and people of low socioeconomic status, yet~     a disproportionate number of these people would benefit from services. Internet-based weight~     loss interventions have been used to deliver services to these populations, but these~     e-Health interventions suffer from a number of limitations and produce only modest weight~     loss. The limitations associated with internet-based interventions include decreased use of~     the internet application over time; patients must logon to the internet to receive treatment~     recommendations, yet few patients regularly logon to the application and this negatively~     affects treatment outcome. An additional limitation is the quality of self-reported food~     intake, exercise, and body weight data that participants enter into the internet application~     or report to their online counselor. Self-reported data are associated with error and~     accurate data are needed to formulate effective treatment recommendations for participants.~     Lastly, most applications rely on asynchronous communications between the patient and the~     counselor, and patients do not always receive personalized treatment recommendations in a~     reasonable amount of time (1 to 3 days), which limits the extent to which the recommendations~     result in behavior change and weight loss.~      The purpose of the proposed pilot and feasibility project is to test the efficacy of the~     Remote Intervention for Diet and Exercise (RIDE) e-Health application at promoting weight~     loss compared to a control condition. The RIDE e-Health application addresses the limitations~     of internet-based interventions that are noted above. The application relies on novel~     technology to collect near real-time food intake, body weight, and exercise data from~     participants while they reside in their free-living environments. These data are transmitted~     to the researchers in near real-time: food intake data are collected and transmitted with~     camera and Bluetoothenabled cell phones using the Remote Food Photography method that was~     developed by this laboratory, body weight data is automatically transmitted daily from a~     bathroom scale using the same phones, and accelerometry is used to collect exercise data that~     is transmitted via the internet. These data are analyzed and personalized treatment~     recommendations are sent to the participant in a timely manner, e.g., every 1 to 3 days,~     using the cell phones. The RIDE e-Health application was developed based on learning and~     behavioral theory to maximize behavior change and weight loss. The findings of this study~     will have significant implications for the affordable delivery of effective weight management~     interventions to patients with limited access to health care.~   "
204617|NCT00883337|"~     Primary objective was to assess the effectiveness evaluated by the time to failure of two~     doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing~     Multiple Sclerosis [MS].~      Secondary objectives were:~        -  To assess the effect of the two doses in comparison to interferon beta-1a on:~             -  Frequency of relapses,~             -  Fatigue,~             -  Participant's satisfaction with treatment.~        -  To evaluate the safety and tolerability of the two doses in comparison to interferon~          beta-1a.~      The study consisted of a core treatment period with a common end date defined as 48 weeks~     after randomization of the last participant, followed by an optional long-term extension~     treatment period until teriflunomide is commercially available in accordance with local~     regulations.~   "
204618|NCT00883324|"~     Observational study to determine whether the proposed method of fFN specimen collection~     without a speculum is substantially equivalent to the approved method with a speculum~     examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in~     symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days in~     asymptomatic women. A finding of substantial equivalency would support a modification to the~     labeling to allow the collection of specimens for fFN determination with or without a~     speculum examination.~   "
204619|NCT00883311|"~     The purpose of the study is to determine whether the topical application of BRT-FC-83C is~     effective in the treatment of mild to moderate atopic dermatitis.~   "
204620|NCT00883298|"~     Primary objective - to determine the 6-month progression free survival (PFS) of adult~     patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly~     temozolomide plus (Avastin) bevacizumab.~      Secondary objectives - to determine radiographic response including specialized MRI~     sequences, safety and overall survival of adult patients with with recurrent glioblastoma~     multiforme/gliosarcoma treated with bi-weekly temozolomide plus bevacizumab (Avastin).~     Additionally, tumor DNA (MGMT) analysis as it relates to survival will be evaluated.~   "
204621|NCT00883285|"~     The purpose of this study is to compare the incidence of silent and apparent cerebral~     embolism between conventional and minimal-invasive transfemoral aortic valve repair.~   "
204622|NCT00883272|"~     The purpose of this study is to determine if Femeralle (DT56a) has an effect on the~     coagulation system, measured by platelet adhesion and aggregation, of normal and~     thrombophilic postmenopausal women.~   "
204623|NCT00883259|"~     Gestational diabetes mellitus (DM) is one of the most frequent complications in pregnant~     patients with polycystic ovary syndrome (PCOS) in 20-40% of cases and ~40% of patients with~     gestational DM are likely to have underlying polycystic ovarian morphology. A recent~     meta-analysis demonstrated a significantly higher risk of developing gestational DM [odds~     ratio (OR) 2.94; 95% confidence interval (CI): 1.70-5.08] in the PCOS population.~      Metformin is an oral biguanide insulin sensitizer used for treating type-2 DM and recently~     introduced to treat PCOS.~      At the moment, preliminary data seem to reassure regarding the use of metformin in PCOS~     patients showing benefits for maternal and fetal outcomes, without serious adverse events.~     Furthermore, well-designed randomized, controlled trials (RCTs) on this issue are lacking,~     thus it is not possible to either suggest or advice against the use of metformin during~     pregnancy for reducing gestational DM risk. To this regard, PCOS represents an intriguing~     model of high-risk patients to evaluate the efficacy of metformin for preventing DM~     development.~      The present protocol firstly will evaluate the effects of metformin administration in~     reducing incidence of gestational DM in high-risk patients, such as pregnant PCOS patients.~   "
204624|NCT00883246|"~     The purpose of the study is to evaluate the intermediate and long-term effectiveness of~     stand-alone atherectomy treatment of peripheral arterial disease in the legs.~   "
204625|NCT00883233|"~     The purpose of this study is to compare the tolerability of 3 treatment regimens containing~     Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5%~     Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The~     efficacy of the four treatment regimens will also be evaluated.~   "
204626|NCT00883220|"~     Learning to self-manage urine flow may help people prevent or minimize persistent~     complications from long-term indwelling urethral or suprapubic catheters.~   "
204641|NCT00883025|"~     Introduction:~      OSAS is an important disease in the actual medic scene. It is important for correlation with~     chronic cardiovascular disease that leaves an increase in morbimortality and socioeconomic~     disability to patients with apnea.~      Objectives:~      Determinate the correlation between Friedman Classification and the obstructive sleep apnea~     syndrome (OSAS) gravity through AHI (Apnea Hypopnea Index) in patients with OSAS for surgical~     indication and evaluation.~      Materials and Methods:~      The investigators evaluated and classified 84 patients, in the scale of Epworth, Friedman and~     how much the gravity of the SAHOS for the AHI.~   "
204785|NCT00881140|"~     The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone~     on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.~   "
204627|NCT00883207|"~     The main aim of the project is to develop couple therapy for depression with special interest~     in dialogical and narrative processes in therapy. Parenthood, and different psychosocial~     phenomena, such as domestic violence, suicidal behaviour and alcohol abuse in relation to the~     client's specific depressive state will be analysed. The second main aim of the study is to~     analyse the effectiveness couple therapy for depression as a real world study. The good and~     poor outcome of different therapy processes will be compared and thus information about~     precise change processes will be reached. Owing to the real world setting, the inclusion~     criterion is a broad one: a primary diagnosis of depression (F32 and F33 in ICD-10).~      The project will be conducted as a multicentre study so that in each centre the included~     patients will be randomized into experiment and control groups. The study centres are (1)~     Pohjois-Savon sairaanhoitopiiri in Kuopio, (2) Länsi-Pohjan sairaanhoitopiiri in Tornio and~     Kemi and (3) HUS/ Jorvin sairaala regional psychiatric polyclinics in Espoo. In each province~     the entire adult population has free access to the psychiatric outpatient clinics in their~     specific catchment area and thus no selection for the patients is done.~   "
204628|NCT00883194|"~     This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel~     formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers.~     PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.~      The purpose of this study is to investigate the safety (side effects if any occurs)~     associated with the single administration of PRF-108 or PRF-110 and evaluate their analgesic~     effect in an experimentally induced pain model compared with ropivacaine Solution 0.5% and~     Vehicle Gel.~   "
204629|NCT00883181|"~     The primary objective was to describe the incidence of febrile neutropenia based on~     granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no~     usage) in patients receiving myelotoxic chemotherapy.~   "
204630|NCT00883168|"~     The purpose of this study is to determine if the combination of two allergy medications~     (formulated azelastine/fluticasone product)is more effective than placebo or either component~     medication alone (azelastine or fluticasone).~   "
204631|NCT00883155|"~     To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting~     Conditions.~   "
204632|NCT00883142|"~     Individuals with neurological deficiencies such as those who have spinal cord injury, stroke,~     traumatic brain injury, Parkinson's disease, and multiple sclerosis often lose their ability~     to ambulate over ground. Loss of functional mobility not only impedes everyday life, but may~     also affect many systems and organs in the body. The investigators are interested in~     obtaining a wide variety of data in order to obtain a better understanding of changes that~     occur as a result of receiving Lokomat therapy. The investigators will be studying body~     composition, cardiac, pulmonary, endocrine, metabolic, and molecular changes after a 12-week~     clinical therapy program.~   "
204633|NCT00883129|"~     Scleroderma is a rare, long-term autoimmune disease in which normal tissue is replaced with~     dense, thick fibrous tissue. Normally, the immune system helps defend the body against~     disease and infection. In people with scleroderma, the immune system triggers fibroblast~     cells to produce too much of the protein collagen. The extra collagen becomes deposited in~     the skin and organs, causing hardening and thickening that is similar to the scarring~     process. Although scleroderma most often affects the skin, it also can affect other parts of~     the body, including the lungs, and in its most severe forms scleroderma can be~     life-threatening. Scleroderma-related interstitial lung disease is one example of a~     life-threatening scleroderma condition. In people with symptomatic scleroderma-related~     interstitial lung disease, scarring occurs in the delicate lung tissue, compromising lung~     function. The purpose of this study is to determine whether people with symptomatic~     scleroderma-related interstitial lung disease experience more respiratory benefits from~     treatment with a 2-year course of mycophenolate mofetil or treatment with a 1-year course of~     oral cyclophosphamide.~   "
204634|NCT00883116|"~     The primary purpose of this study is to investigate whether administration of ixabepilone~     results in superior outcome as assessed by overall survival compared with that achieved with~     standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer~     that has progressed following first-line chemotherapy.~   "
204635|NCT00883103|"~     The purpose of this study is to compare the pain perception between lidocaine and plain~     aqueous gel during assessment of postvoid residual volume and the Q-tip test.~   "
204636|NCT00883090|"~     Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with~     potentially life-threatening bleeding. This study will evaluate the safety and recommended~     (best) amount or level of Factor XIII in a patient's blood. Factor XIII Concentrate (Human)~     is given to people whose blood is lacking Factor XIII. Factor XIII Concentrate (Human) works~     by assisting your blood in the usual clotting process, thereby preventing bleeding.~   "
204637|NCT00883077|"~     The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in~     assessment of colonic permeability against conventional sugar absorption test.~   "
204638|NCT00883064|"~     To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting~     Conditions.~   "
204639|NCT00883051|"~     The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of~     COL-144 in treating migraine headache, in order to select a dose or doses for further~     evaluation.~   "
204640|NCT00883038|"~     The aim of the study is to evaluate the effect of experimental (vegetarian) diet compared to~     conventional diet with similar caloric restriction on insulin resistance, body weight and~     body composition in type 2 diabetic patients after 3 month diet program and additional 3~     month diet program combined with intensive exercise.~      Hypothesis: Greater improvement in insulin resistance, greater weight loss without~     compromising the body composition (subjects will lose fat preferentially to lean body mass)~     and differences in the fatty tissue metabolism will be found in the experimental (vegetarian)~     group compared to the control (conventional diet) group despite the similar advise on caloric~     restriction in both diets. The differences between the two groups will increase after an~     intensive physical exercise program.~   "
204672|NCT00882622|"~     The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on~     cardiac function in patients undergoing cardiac surgery compared to control intervention.~   "
204786|NCT00881127|"~     To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine~     Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.~   "
204642|NCT00883012|"~     Influenza associated pneumonia causes significant morbidity in young HIV-infected children.~     Although annual vaccination against influenza is recommended for HIV infected children, it~     has not been implemented as routine care, due to the lack of data on disease burden and~     vaccine efficacy.~      This study aims at determining the effectiveness of influenza vaccination in HIV infected~     children in South Africa.~   "
204643|NCT00882999|"~     To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12,~     16, 20, and 24 weeks compared to placebo.~   "
204644|NCT00882986|"~     The purpose is to determine whether regular endurance exercise and/or body weight influence~     the way our nervous and vascular systems respond during the metabolism of meals.~   "
204645|NCT00882973|"~     This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II~     dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus~     gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and~     combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced~     or metastatic pancreatic cancer.~   "
204646|NCT00882960|"~     Goal of the research will be to demonstrate a reduction in reported pain following the~     atomization and intra-nasal administration of Fentanyl versus the reduction in pain achieved~     from intravenous Fentanyl. It is hypothesized that pain should be reduced following fentanyl~     administration using the intra-nasal atomization equal to the intravenous delivery.~   "
204647|NCT00882947|"~     The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost~     (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in~     compliance with Chinese SFDA regulation.~   "
204648|NCT00882934|"~     Placebo-controlled randomized clinical trials (RCT) are the gold standard to provide~     applicable evidence for clinical practice. A vast number of RCTs for treatment of several~     disorders has shown a mean placebo effect of 30%. Erectile dysfunction (ED) is a high~     prevalent disease and its first-line therapy is oral phosphodiesterase type-5 inhibitor~     (iPDE5) (i.e., sildenafil, vardenafil and tadalafil). Although the placebo effect in iPDE5~     RCT occurred at a rate as high as 50%, in the last decade, with the revolutionary discovery~     of effective pharmacotherapy for ED, oral iPDE5 has become one of the most common prescribed~     drugs for men. The objective of this study is to evaluate the influence of patients'~     awareness on the composition of the therapeutic drug in the outcomes of the oral treatment~     for ED.~   "
204649|NCT00882921|"~     The objective of this study is to evaluate the effect of anti-idursulfase antibodies on~     idursulfase safety (measured by infusion related adverse events) between patients who develop~     anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme~     replacement therapy (ERT).~   "
204650|NCT00882908|"~     The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in~     combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the~     proportion of patients with sustained virologic response at Week 72 (patients with~     undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and~     at Week 72), compared to the control group receiving PegIFN and RBV in combination with~     TMC435-matched placebo.~   "
204651|NCT00882895|"~     This is a research study testing a new approach to treating high-risk non-Hodgkin's lymphoma~     consisting of an autologous hematopoietic (blood) stem cell transplant (using a patient's own~     hematopoietic cells) followed by a non-myeloablative allogeneic transplantation (transplant~     from another individual).~      The investigators hypothesize that the addition of the second non-myeloablative transplant~     will improve the chances for long-term control of lymphoma.~   "
204652|NCT00882882|"~     To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting~     conditions.~   "
204653|NCT00882869|"~     AEG35156 is a second generation antisense which targets XIAP mRNA to lower XIAP levels and~     the apoptotic threshold of cancer cells, enhancing their sensitivity to intrinsic death and~     chemotherapy. Advanced HCC is an attractive target for AEG35156 since XIAP is highly~     expressed in HCC and may prevent cancer cells from undergoing apoptosis. Second generation~     antisense molecules are known to accumulate in liver where AEG35156 may down regulate XIAP~     protein expression in HCC cells thus promoting their apoptotic death.~   "
204654|NCT00882856|"~     Clozapine-induced sinustachycardia occurs in 25% of patients treated with clozapine and~     sustained sinustachycardia might be a risk factor for dilated cardiomyopathy. This~     double-blinded cross over placebo controlled study investigate whether 10 mg bisoprolol are~     efficient in treating clozapine-induced sinustachycardia measured as heart rate, heart rate~     variability, QTc and T-wave morphology.~   "
204655|NCT00882843|"~     In persons with SCI, because of inherent considerations, the use of mechanical stimulation~     has not been studied to determine improvement in bone mass. To achieve maximum transmission~     of the vibration from a vibrating plate to the lower body, the legs must be extended and the~     feet firmly placed against the surface plate of the device. Thus, these logistical~     considerations must be addressed to perform this mechanical intervention in persons with SCI.~     In those with complete or almost complete motor injury, there is lack of musculoskeletal~     function below the level of the lesion, which would prevent rigid straight leg extension and~     pressing one's feet against a surface, regardless of the angle of tilt that would permit~     adequate transmission of impulse in an able-bodied individual (preliminary data). However, in~     one subject with SCI, there was measurable, albeit low level, transmission of vibration with~     increasing angles of tilt (preliminary data). Because of the ability to transmit some signal~     in an individual with complete SCI, the possibility exists that with forms or mechanical~     support/manipulation, greater signal transmission may be possible. The study will be able to~     determine the best angle to transmit mechanical vibration through the lower body of SCI~     patients.~   "
204656|NCT00882830|"~     The purpose of this study is to investigate the role of EMS as a preventive and therapeutic~     tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM~     or have a beneficial role as a therapeutic means in case of CIPNM appearance.~   "
204673|NCT00882609|"~     The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT~     scanning to that of conventional bone scanning for detecting cancer that has spread to the~     bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT~     will lead to improved treatment and patient outcomes.~   "
204657|NCT00882817|"~     Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary~     rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such~     as chronic obstructive pulmonary disease (COPD). This prospective randomized controlled study~     aims to evaluate the short and long-term effects of PR in patients with ILD. For this~     purpose, 60 ILD patients will be randomly assigned to a PR or a control group.~      The investigators hypothesize that PR will improve exercise capacity, increase muscle force,~     reduce dyspnea and improve quality of life and daily life activities in ILD patients.~   "
204658|NCT00882804|"~     This study is being done because we want to learn if hemin can increase the production of~     heme oxygenase 1. Heme oxygenase 1 (HO-1) is an enzyme which protects cells from physical,~     chemical, and biologic stress. Hemin is produced from red blood cells and is approved by the~     Food and Drug Administration for treating acute porphyria, which is an inherited condition~     caused by an enzyme deficiency.~   "
204659|NCT00882791|"~     Basal cell carcinoma (BCC) is the most common skin cancer in the US and can cause significant~     adverse effects.~      Mohs micrographic surgery, the treatment of choice for higher risk BCC, allows for removal of~     lesions with preservation of healthy tissue. Although the BCC recurrence rate post Mohs~     surgery is estimated at 1-2%, recent data is lacking to validate this historical measurement.~      Our purpose is to determine the current recurrence rate of BCC after Mohs surgery.~   "
204660|NCT00882778|"~     This study is conducted in Europe and North and South America. The primary aim of this~     observational study is to evaluate the frequency and pattern of bleeding episodes in~     haemophilia patients receiving preventative treatment with activated recombinant human factor~     VII. The secondary aim is to evaluate which patients are selected for this treatment, the~     dose and dose intervals used, and the safety of activated recombinant human factor VII when~     used as prevention. The study also aims to increase understanding of the unmet medical need~     and clinical relevance of preventative treatment in haemophilia patients.~   "
204661|NCT00882765|"~     RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving genistein before~     surgery may be an effective treatment for pancreatic cancer.~      PURPOSE: This randomized phase II trial is studying genistein to see how well it works in~     treating patients with pancreatic cancer that can be removed by surgery.~   "
204662|NCT00882752|"~     The method used for the biopsy analysis may be able to provide important insights into the~     complex microbial communities found in the human colon or in complex human infections.~     Therefore, this methodology may prove useful to other researchers or physicians.~   "
204663|NCT00882739|"~     The aim of this study is to determine both safety and effectiveness of three different~     loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing~     primary angioplasty.~   "
204664|NCT00882726|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics~     of CNTO 3649 following a single dose in healthy adults and following multiple doses in~     patients with Type 2 Diabetes Mellitus.~   "
204665|NCT00882713|"~     This single arm study will assess the efficacy, safety and tolerability of once monthly~     administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis~     patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting~     dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of~     epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to~     maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the~     target sample size is 200 individuals.~   "
204666|NCT00882700|"~     To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting~     conditions.~   "
204667|NCT00882687|"~     The purpose of this study is to determine whether SAR 1118 at three different concentrations,~     compared to placebo, is effective in the prevention of the signs and symptoms of allergic~     conjunctivitis~   "
204668|NCT00882674|"~     This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor~     cells in female patients with operable breast cancer. In the first part of the study,~     patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment~     (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R~     expression. If sufficient biological activity is demonstrated, 3 additional cohorts of~     patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or~     1mg/kg iv R1507, respectively. The anticipated time on study treatment is < 3 months, and the~     target sample size is <100 individuals.~   "
204669|NCT00882661|"~     The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of~     the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease~     at one level between C3 and C7, compared to anterior cervical discectomy and fusion.~      The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy~     associated with the use of the SECURE-C Cervical Artificial Disc~   "
204670|NCT00882648|"~     Previous studies by this team of investigators has determined that male infants are more~     likely to display more severe neonatal abstinence syndrome (NAS) as a result of maternal~     opioid use during pregnancy (Jansson, 2007)and there is appears to be a gender-related~     biologic vulnerability to NAS expression (Jansson, 2009, submitted). The proposed study~     explores the relationship between fetal gender and substance abuse treatment outcomes among a~     population of women in comprehensive substance abuse treatment to explore the possibility of~     a psychosocial vulnerability among drug exposed male fetuses as opposed to female fetuses.~     Women in substance abuse treatment are a group at high risk for current exposure to violence,~     usually at the hands of significant others, and having a history of sexual abuse as a child,~     usually resulting from contact with a male family member. Therefore, they often have~     difficult relationships with men. At the Center for Addiction and Pregnancy (CAP), a 2006~     study revealed that among a group of 715 pregnant women, reports of the exposure to violence~     was very high. Their rates of lifetime abuse ranged from 72.7% for physical abuse to 44.5%~     for sexual abuse. Rates of abuse remained high during their current pregnancy, ranging from~     20% for physical abuse to 7.1% for sexual abuse (Velez, 2006). The abuse was very often at~     the hands of partners or other male family member perpetrators. We hypothesize that women~     carrying male fetuses will be less likely to remain complaint in drug treatment or abstinent~     from illicit drug use, while women carrying female fetuses may be more likely to remain drug~     abstinent and treatment compliant. If supported, this theory has the potential to inform~     fetal gender specific treatment for pregnant drug dependent women. Additionally, we seek to~     support the previously documented link between male gender and more severe expression of NAS,~     and explore the relationship between other maternal prescribed drug use (i.e. psychotropic~     medications) and severity of NAS expression.~   "
204671|NCT00882635|"~     The purpose of this study is to assess the safety and efficacy of Enoxaparin and~     Unfractionated Heparin in St Elevation Myocardial Infarction patients undergoing primary~     percutaneous coronary intervention.~   "
204675|NCT00882583|"~     Primary Objective for Phase I~        1. To determine the maximally tolerated dose (MTD) of daily Oral dasatinib in combination~          with cetuximab/RT in Cohort A, in patients with AJCC stage II (T2N0) and III (T1-2N1)~          SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx.~        2. To determine the MTD of daily oral dasatinib in combination with cisplatin/cetuximab/RT~          in Cohort B, in patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0)~          squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, and larynx.~           Primary Objectives of Phase II~        3. To estimate the objective tumor response rate and toxicity in Patients treated in~          expanded Cohort A and B.~   "
204676|NCT00882570|"~     To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting~     conditions.~   "
204677|NCT00882557|"~     The purpose of this study is to determine whether daptomycin at a higher dose given during~     the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after~     a dialysis session.~   "
204678|NCT00882544|"~     Performance and outcomes measure are, at this time, relatively unknown for robotic~     pyeloplasty procedures. The purpose of this study is to provide a clearer understanding of~     the urology department's robotic pyeloplasty quality and outcomes measures. This will be~     accomplished by prospectively collecting data for these procedures would ensure that measures~     are consistently collected in accordance with a defined protocol, allowing for more valuable~     quality and clinical research analysis.~      Hypothesis will be defined before data analysis is performed. Amendments specifying future~     hypothesis will be submitted the IRB at the appropriate time.~   "
204679|NCT00882531|"~     A national, multicentre, prospective, randomised, double-blind, phase III study in 2 parallel~     groups of isotretinoin versus placebo in patients presenting papular-pustular rosacea~     resistant to standard therapy. A non-balanced group (2 isotretinoin /1 placebo) design was~     selected since, given the nature of the study disease, fewer patients will receive the~     placebo than active isotretinoin.~      Treatment duration for each patient : 4 months, with monthly evaluation Follow-up at 2 months~     and 4 months for patients responsive after 4 months of treatment.~   "
204680|NCT00882518|"~     The primary objective of this study is to evaluate the efficacy of quetiapine fumarate~     extended-release (XR) used as mono-therapy, administered once daily, in the treatment of~     schizophrenic patient with acute episode.~   "
204681|NCT00882505|"~     The objective of this study is to assess whether vitamin D supplements are sufficient to~     increase females who are deficient or borderline deficient in vitamin D levels to normal~     levels.~   "
204682|NCT00882492|"~     This is a medical research study designed to see if an infusion of a naturally occurring~     hormone, GLP-1, works when used to decrease blood sugar during cardiac surgery.~   "
204683|NCT00882479|"~     The purpose of this study is to learn the daily activities of nutrition management software~     users through an improved informed consent process and develop a conceptual model to describe~     these activities. The investigators will gather information from nutrition management~     software users, and design and test a new prototype of nutrition management software.~   "
204684|NCT00882466|"~     The purpose of this study is to investigate the effect of intravenous human recombinant~     erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in~     patients with acute myocardial infarction.~   "
204685|NCT00882453|"~     The purpose of this observational study is to obtain a survey on physical activity in~     patients who for the first time have experienced symptoms which indicate a high risk for~     developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain~     information on factors potentially influencing the patients' level of activity.~   "
204686|NCT00882440|"~     The purpose of this study was to compare the antihypertensive efficacy of different doses of~     losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure~     of 100-115 mmHg.~   "
204687|NCT00882427|"~     Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated~     that tight blood glucose control in medical and surgical ICU patients results in a~     significant better outcome for the patients. Based on this emerging clinical evidence, there~     are increasing efforts worldwide to maintain strict glycaemic control in critically ill~     patients. However, achieving this goal requires extensive nursing efforts, including frequent~     bedside glucose monitoring and the implementation of complex intensive insulin infusion~     protocols. A fully automated algorithm may help to overcome some of these limitations by~     excluding intuitive interventions and integrating relevant clinical data in the~     decision-making process. This study will investigate the performance of an eMPC algorithm~     adjusted to target the range 4.4 - 8.3 mmol/L in line with the Surviving Sepsis guidelines.~   "
204688|NCT00882414|"~     The aim of this study is to show the benefits for patients, with a high platelet count, iron~     deficiency and IBD, receiving intravenous iron therapy.~   "
204689|NCT00882401|"~     Overall research aims: This study will examine the effect of vitamin D supplementation on the~     function of the endothelium and microcirculation of patients with chronic kidney disease and~     vitamin D deficiency.~      Hypothesis: Vitamin D therapy in patients with CKD and concomitant vitamin D deficiency will~     improve endothelial, and therefore microcirculatory function, reduce levels of oxidative~     stress and thus reduce the risk of future CVS events in this population.~   "
204690|NCT00882388|"~     Background:~        -  The prevalence of arthritis which needs celecoxib prescription is high in patients with~          coronary artery disease.~        -  The main concern is that celecoxib would increase thrombogenicity by inhibiting the~          synthesis of prostacyclin in endothelial cells.~        -  It is not known whether the administration of celecoxib would deteriorate antiplatelet~          effects of aspirin and clopidogrel which are used after stenting.~      Methods:~        -  Healthy volunteers (n=40)~        -  Randomization into five subgroups~        -  aspirin, celecoxib, aspirin+celecoxib, aspirin+clopidogrel,~          aspirin+clopidogrel+celecoxib~        -  Medication schedule : medication of each drug for 6 days, blood samples at day 0 and day~          7~        -  Celecoxib 200mg twice a day, and/or aspirin 100mg daily, and/or clopidogrel 75 mg daily~        -  Platelet function test : light transmittance aggregometry and arachidonic acid~          metabolite assay among subgroups.~      Study hypothesis : The addition of celecoxib does not deteriorate antiplatelet function of~     aspirin and clopidogrel.~   "
204691|NCT00882375|"~     A comparison of a novel nicotine replacement therapy and placebo treatment in smokers~     motivated to quit smoking.~   "
204692|NCT00882362|"~     To examine the safety and efficacy of long term administration of aripiprazole as an~     adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor~     (SSRI) or a selective-norepinephrine reuptake inhibitor (SNRI), in subjects with major~     depressive disorder.~   "
204693|NCT00882336|"~     The main objective of this study is to describe the management of patients with~     cardiovascular risk factors in primary prevention among different European countries.~      The patient's participation consists of a single study visit during a routine visit of the~     patient to the clinic/office.~      Study variables will be measured:~        -  By an interview between physician and patient during the visit and/or available medical~          records' information: social and demographic patient characteristics, relevant family~          medical history, current medication.~        -  By questions asked to the physician: physician perception of patients' CV risk factor,~          guidelines adherence and cost-containment.~        -  By measurement performed to the patient during the visit: weight, height, BMI, waist and~          hip circumference will be measured.~        -  CV risk factors (blood parameters) will be measured by collecting available data~          documented within the last year in the medical records and by the collection and~          analyses of a blood sample during the visit.~   "
204694|NCT00882323|"~     Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the~     conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found~     to be more effective in preventing graft versus host disease (GVHD) and rejection of organ~     transplants. As the fludarabine based conditioning regimens without total body irradiation~     have been reported to be promising for transplantation from alternative donors in SAA,~     thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and~     to allow good engraftment in unrelated donor transplantation. Our previous phase II study of~     fludarabine, cyclophosphamide plus thymoglobulin conditioning resulted in good engraftment~     (100%) and survival rate (74%). But grade III/IV toxicities occurred in 25% of patients and~     all events were treatment related mortalities. As cyclophosphamide is more toxic agent than~     fludarabine, we plan a new phase II study re; 'reduced toxicity fludarabine, cyclophosphamide~     plus thymoglobulin conditioning regimen for unrelated donor transplantation in severe~     aplastic anemia' by reducing dosage of cyclophosphamide and increasing dosage of fludarabine.~   "
204695|NCT00882310|"~     The main purpose of this study will be to evaluate the toxicities as well as the efficacy of~     a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in~     patients with pancreatic cancer, who have undergone complete surgical resection of their~     tumor. During the screening evaluation, subjects will have a physical exam and medical~     history taken by either the PI or a Co investigator. In addition, routine blood tests and~     radiological exams will be performed, to determine eligibility. Following enrollment,~     patients will receive 8 cycles (1 cycle = 21 days) of GTX treatment over 6 months. During~     each cycle patients will receive Gemzar and Taxotere on days 4 and 11, through an IV, over~     the course of approximately 2 hours, and Xeloda will be taken orally for the first 14 days of~     every cycle. Patients will receive no treatment on days 15 thru 21 of each cycle. During each~     cycle of treatment patients will have a physical examination, as well as routine blood work.~     The first scan will be done prior to initiation of treatment, and the next will be done at~     completion of chemotherapy. A short quality of life questionnaire will also be administered~     prior to cycle 1 treatment, at the 3-month point, and at the completion of chemotherapy.~   "
204696|NCT00882297|"~     There is actually two techniques of subclavian vein ultrasonography-guided venous~     catheterization : the axial and longitudinal approach. Currently, nothing makes it possible~     to privilege one technique compared to the other. This study aims to determine the best~     ultrasonography-guided method.~   "
204697|NCT00882284|"~     This observational study collects information on the current incidence and management of~     hypotension in babies born at term or late preterm that are admitted to Neonatal Intensive~     Care Units (NICUs) within the Neonatal Research Network (NRN). Participants include all~     newborn infants born at 34 0/7 weeks gestation or greater who are admitted to NICU Network~     centers and intubated and mechanically ventilated at less than 72 hours of age. The~     information gathered will provide a framework for the design of a potential randomized~     controlled trial for the treatment of hypotension in neonates. This observational study is~     for a time-limited enrollment period of 4-6 months; NRN centers will continue to enroll until~     at least 50 patients are enrolled per center (for approximately 800-1,000 subjects total).~   "
204698|NCT00882271|"~     The acupuncture treatment in this study is particularly aimed at reducing the pain and other~     negative health events such as emotional trauma and disability associated with Fibromyalgia,~     while improving the quality of life and promoting general health.~   "
204699|NCT00882258|"~     Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days.~     Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly~     for the three month treatment phase.~   "
204700|NCT00882245|"~     Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children~     and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large~     parts of the body. The exact cause is unknown but is thought to be an interplay between~     genetic and and environmental factors. The objective of this study is to determine whether~     SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.~   "
204701|NCT00882232|"~     The primary purpose of this study is to determine if cross-linked hyaluronan gel reduces the~     dose of radiation delivered to the rectum and the rectal toxicity of radiotherapy for~     localized prostate cancer.~   "
204702|NCT00882219|"~     Interventional, prospective, non-randomized, non-comparative, open and multicentric study of~     patients with everolimus-eluting stent  Xience V®  implanted in the treatment of restenosis~     in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up~     period.~   "
204703|NCT00882206|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Decitabine and~     vorinostat may alter the cancer cells by reversing the cancer pathways needed for cell~     growth. Giving more than one drug (combination chemotherapy) together with decitabine and~     vorinostat may kill more cancer cells than with chemotherapy alone.~      PURPOSE: This phase II trial is studying how well giving decitabine and vorinostat together~     with combination chemotherapy works in treating patients with acute lymphoblastic leukemia or~     lymphoblastic lymphoma that has relapsed or not responded to treatment.~   "
204704|NCT00882193|"~     This is a non-randomized, open-label study examining the safety and efficacy of betaine in~     addition to standard anti-viral therapy in genotype 1 hepatitis C non-responders or relapsers~     to previous pegylated interferon plus ribavirin. Betaine (20 gm/day) in 2 divided doses will~     be added to Peginterferon alpha 2a (180 mcg) plus weight-based Ribavirin (1000 or 1200~     mg/day, for body weight < or > 75 kg, respectively, for 48 weeks. Patients must be diagnosed~     with chronic hepatitis C, genotype I, and have undergone therapy for hepatitis C with~     pegylated interferon plus ribavirin. Subjects will be followed for safety, tolerability,~     hepatitis C viral response and the effect on interferon gene signaling in peripheral blood~     mononuclear cells during therapy.~   "
204705|NCT00882180|"~     The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced~     solid tumors with liver involvement.~   "
204706|NCT00882167|"~     Official title:~      Sensitivity and predictive value of functional cine magnetic resonance imaging (MRI)~     detecting intra-abdominal adhesions~      Background:~      Adhesions are a frequent problem in abdominal surgery. The formation of adhesions is part of~     a normal wound healing. However in some patients adhesions cause severe complications such as~     chronic pain, obstruction and strangulation of the bowel. Adhesions can also obstruct access~     to the peritoneal cavity and complicate reoperations. Accurate imaging of adhesions would be~     of benefit avoiding adhesion related complications at repeated laparotomy or laparoscopy. At~     present no validated diagnostic tool mapping adhesions exists.~      Purpose:~      To define the sensitivity and specificity of functional cineMRI in detecting and mapping~     adhesions in patients undergoing reoperation.~      Design:~      Prospective multicenter observational trial~      Primary outcome:~      Sensitivity and specificity of functional MRI detecting adhesions to the abdominal wall~      Secondary outcome:~      Sensitivity and specificity of functional MRI detecting organ-to-organ adhesions.~      Estimated enrollment: 100 Start study: april 2009~      Estimated study completion date: dec 2010~      Estimated primary completion date: jun 2010~   "
204707|NCT00882154|"~     To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed~     conditions.~   "
204708|NCT00882141|"~     The purpose of this study is to test the hypotheses that there are ethnic and genetic~     differences in the mechanisms and magnitude by which hypocaloric weight loss and aerobic~     exercise affect body composition, glucose, lipid, muscle and adipose tissue metabolism in~     overweight, insulin resistant postmenopausal women. This will be tested in a trial comparing~     the effects of weight loss vs. aerobic exercise plus weight loss on glucose, lipid, fat and~     muscle metabolism in overweight African American and Caucasian postmenopausal women.~   "
204709|NCT00882128|"~     To evaluate the level of control of Asthma (GINA : controlled, partially controlled, not~     controlled) of asthmatic patients consulting their general practitioner for a seasonal~     increase of respiratory symptoms (high and / or low) whether an inhaled corticotherapy is~     taken or not.~   "
204710|NCT00882115|"~     Allergic airway disease is a term used to describe conditions such as allergic rhinitis and~     asthma. Among other causative agents, air pollutants and diesel exhaust in particular, have~     been shown to create and also worsen existing allergic airway disease. These inhaled~     pollution particles have oxidative properties that drive inflammation-related effects through~     specific metabolic-associated processes. These processes are not adequately suppressed by~     current therapeutics. The purpose of this study is to explore the effects of broccoli sprout~     extract on the inflammatory process in the nose caused by diesel exhaust particles, which are~     important elements in air pollution. Broccoli sprout extract is a very potent inducer of~     Phase II enzymes (natural antioxidants).~   "
204711|NCT00882102|"~     The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine)~     given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control Acute myeloid~     leukemia (AML), high-risk myelodysplastic syndromes (MDS) or Myelofibrosis (MF). The safety~     of this drug combination will also be studied.~   "
204712|NCT00882089|"~     The purpose of this study is to determine if a Contura catheter can avoid a radiation hot~     spot in the skin and improve tissue-balloon conformance in early-stage breast cancer~     patients undergoing accelerated partial breast irradiation.~   "
204713|NCT00882076|"~     The purpose of this study is to establish toxicity and a maximum tolerated dose recommended~     phase 2 dose of Clofarabine in combination with Etoposide and Mitoxantrone for therapy of~     relapsed or refractory acute leukemias. The investigators will observe responses with these~     therapy agents and assess the impact of Clofarabine interacting with Etoposide in induction~     of DNA strand breaks.~   "
204714|NCT00882063|"~     The purpose of this study is to determine safety of P276-00 in patients with advanced~     multiple myeloma and whether P276-00 is effective in the treatment of advanced cases of~     multiple myeloma.~   "
204715|NCT00882050|"~     The purpose of this project is to study if intravenous Exenatide is effective at maintaining~     normal blood glucose levels and preventing low blood glucose levels during surgery.~   "
204716|NCT00882037|"~     The primary goal of this study is to identify factors which may put a person that has used~     methamphetamine at greater risk for mental and physical health problems and social problems~     and factors that may lessen the risk for these problems. This study will also compare~     methamphetamine use between Latino and non-Latino persons and those that live in a rural area~     or urban area. The investigators hypothesis is that rural persons with methamphetamine~     dependence will have greater socio-demographic, bio-psychosocial and behavioral risk factors~     than their urban counterparts.~   "
204717|NCT00882024|"~     The purpose of this study is to evaluate whether tranilast at two different dosages compared~     to placebo is effective in patients with active RA when added to continuing methotrexate~     (MTX) therapy.~   "
204718|NCT00882011|"~     The purpose of the study is to create a prospective database of T-Lymphoblastic Lymphoma~     (T-LBL) cases in order to conduct an appropriate statistical study as well as to monitor~     diagnosis and minimal residual disease (MRD), to detect specific genetic profile useful to~     give advices on therapies, to assess if PET has a prognostic validity on T-Lymphoblastic~     Lymphoma (T-LBL).~   "
204719|NCT00881998|"~     A prospective, comparative, randomized single surgeon study comparing minimally invasive~     total hip arthroplasty (MIS) via anterior approach to conventional total hip arthroplasty via~     anterolateral transgluteal approach.~   "
204724|NCT00881933|"~     Severe aplastic anemia is a fatal disease and patients without HLA matched siblings need~     alternative treatment option. Cord blood transplantation (CBT) has become an alternative~     treatment means in various diseases, but it has not been proved to be good for severe~     aplastic anemia. Double units CBT is proposed to have better engraftment potential and and we~     reported successful double units UCBT after engraftment failure with single unit with~     promising result. To increase the engraftment potential, fludarabine, cyclophosphamide plus~     TBI conditioning regimen for double units cord blood transplantation was proposed for the~     patient with severe aplastic anemia without HLA-matched donor.~   "
204725|NCT00881920|"~     Patients have a type of cancer called NHL, Multiple Myeloma (MM) or CLL that has come back or~     has not gone away after treatment. There is no standard treatment for the cancer at this time~     or the currently used treatments do not work completely in all cases like these. This is a~     gene transfer research study using special immune cells.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting disease,~     antibodies and T cells, that investigators hope will work together. Antibodies are types of~     proteins that protect the body from bacterial and other diseases. T cells, also called T~     lymphocytes, are special infection-fighting blood cells that can kill other cells, including~     tumor cells. Both antibodies and T cells have been used to treat patients with cancers; they~     have shown promise, but have not been strong enough to cure most patients.~      The antibody used in this study recognizes a protein on the lymphoma, MM or CLL cells called~     kappa immunoglobulin. Antibodies can stick to lymphoma, MM or CLL cells when it recognizes~     the kappa molecules present on the tumor cells. For this study, the kappa antibody has been~     changed so that instead of floating free in the blood it is now joined to the T cells. When~     an antibody is joined to a T cell in this way it is called a chimeric receptor. These~     chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long and~     so their chances of fighting the cancer are limited.~      In the laboratory, investigators found that T cells work better if they also add a protein~     that stimulates T cells to grow called CD28. By joining the anti-kappa antibody to the T~     cells and adding the CD28, the investigators expect to be able to make cells that will last~     for a longer time in the body (because of the presence of the CD28). They are hoping this~     will make the cells work better.~      Previously, when patients enrolled on this study, they were assigned to one of three~     different doses of the kappa-CD28 T cells. We found that all three dose levels are safe. Now,~     the plan is to give patients the highest dose that we tested.~      These chimeric T cells (kappa-CD28) are an investigational product not approved by the FDA.~   "
204726|NCT00881907|"~     The purpose of the investigators study is to characterize the composition of the hard and~     soft tissues present in root canals of teeth previously diagnosed with necrotic pulps and~     incomplete root formation and treated with a triple antibiotic regeneration protocol. The~     investigators hypothesis is that treatment of teeth with necrotic pulps and immature apices~     with triple antibiotic paste will stimulate continued root formation by the deposition of~     dentin at the root apices. The primary outcome measure will be histological identification of~     mineralized tissue and adherent cells in the apical third of these teeth.~   "
204727|NCT00881894|"~     The major aim of this study is to investigate and compare the drug amount delivered to the~     body after sequential application of 2 rotigotine transdermal patches from 2 different~     manufacturing processes.~   "
204728|NCT00881881|"~     This is an epidemiological, multicenter, retrospective study to analyze the management of~     rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be~     analyzed: individuals who have had RA for two years or less (the early RA group) and~     individuals who have had RA for more than 2 years and who currently meet the ACR criteria for~     RA (the established RA group).~   "
204729|NCT00881868|"~     The primary objective of this study is to evaluate the safety and efficacy of clobetasol~     propionate spray versus vehicle spray for the management of moderate to severe plaque~     psoriasis of the scalp.~   "
204730|NCT00881855|"~     The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg~     Cefprozil Tablets Under Fed Conditions.~   "
204731|NCT00881842|"~     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in~     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of~     these vaccines are required to be involved in ongoing clinical trials and to present the~     results to the competent authorities each year. The current study is a phase IIIa clinical~     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It~     is part of the ongoing clinical trial program for Influvac® and will be done to assess the~     immunogenicity and safety and tolerability of next season's trivalent influenza subunit~     vaccine in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and~     subjects >= 61 years of age (elderly).~   "
204732|NCT00881829|"~     The purpose of this study is to evaluate the SpO2 accuracy and performance of the Oxitone~     Medical Oxitone 1000 pulse oximeter during non-motion conditions over the range of 70-100%~     SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.~      This study is observational in nature which quantifies device performance and accuracy in~     comparison to a Reference Standard.~   "
204733|NCT00881816|"~     The purpose of this study is to determine the maximum tolerated dose and dose limiting~     toxicity of liposomal paclitaxel plus capecitabine in Chinese patients with advanced gastric~     carcinoma.~   "
204734|NCT00881803|"~     Iron overload is a life-threatening condition that can lead to liver disease, cardiac~     disease, diabetes and arthritis. Simultaneous supplementation with both iron and AA may place~     individuals with SCI at risk for iron overload as well as oxidative damage by iron-generated~     free radicals. Both conditions of high and low iron stores may present with common signs and~     symptoms. Accurate diagnosis of iron disorder should consider CRP, hematocrit, hemoglobin,~     serum iron, TIBC, percent saturation of iron binding capacity, serum ferritin and hepcidin.~      The investigators are proposing a study to determine the effect of concurrent AA and iron~     supplementation on iron status of individuals with SCI. The investigators goal is to identify~     abnormal status that may be attributed to simultaneous supplementation of iron and AA to~     develop future supplementation protocols in this population for optimal iron status.~   "
204735|NCT00881790|"~     The behaviour of 12 dental nurses seeing 600 nursery school children in East Scotland will be~     video-taped to determine the interaction patterns adopted by the staff in the application of~     a fluoride varnish to the surfaces of the child's teeth. The aim is to test the benefit of~     certain communication strategies used by the nurses to affect an efficient application~     controlling for nursery school site, age of child and experience of dental nurse.~   "
204736|NCT00881777|"~     The purpose of this study is to examine the safety and potential effectiveness of a new~     surgical procedure for treating heart failure. The experimental treatment is performed during~     standard coronary artery bypass graft (CABG) surgery, and applies radiofrequency energy to~     heat a portion of the damaged heart muscle. The tissue heating reduces the enlarged heart of~     patients suffering from ischemic heart failure, and may result in the heart pumping blood~     more efficiently, thereby improving the functional status of the patient.~   "
204737|NCT00881764|"~     The purpose of this study is to determine whether the use of anesthetic agents in infants and~     children have long term adverse effects on neurocognitive development. According to the~     National Hospital Discharge Survey, around 2.5 million children have surgical procedures~     requiring anesthesia each year in the US. Recent animal studies have suggested that the~     exposure of the immature organism to a variety of commonly used anesthetic agents may lead to~     neurobehavioral functional deficits in vivo and to neuronal apoptosis in vitro. While the~     relevance of these findings on children exposed to anesthetics remains to be determined, it~     is clearly critically important to public health that this issue is resolved quickly and~     clearly.~      Hypothesis: Exposure to anesthetic agents within the first three years of life will not~     significantly impair cognitive functions at ages 8 yr, 0 mo to 15 yr, 0 mo.~   "
204738|NCT00881751|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Erlotinib and sorafenib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Bevacizumab, erlotinib, and sorafenib may also stop the growth of tumor cells by blocking~     blood flow to the tumor. It is not yet known whether giving bevacizumab together with~     erlotinib is more effective than giving sorafenib in treating patients with liver cancer.~      PURPOSE: This randomized phase II trial is studying how well giving bevacizumab together with~     erlotinib works compared with sorafenib as first-line therapy in treating patients with~     advanced liver cancer.~   "
204739|NCT00881738|"~     To demonstrate the relative bioavailability of Clarithromycin 250 mg tablets under fasting~     conditions.~   "
204740|NCT00881725|"~     This study will investigate the effect of neoadjuvant metformin therapy in the inhibition of~     growth and proliferation of prostate cancer cells prior to radical prostatectomy.~   "
204741|NCT00881712|"~     The purpose of this study is to find out what effects, good and/or bad, proton radiation at a~     higher tumor dose (and lower normal surrounding lung dose) combined with standard~     chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the~     standard dose. This may be able to increase the control of the tumor. Due to the accuracy of~     radiation given with protons, the dose to the normal lung tissue that surrounds the tumor~     will be lower than standard. This may be able to reduce the frequency and severity of the~     usual radiation side effects.~   "
204742|NCT00881699|"~     This study will test the effectiveness of a program aimed at reducing behaviors that increase~     HIV risk among people with severe mental illnesses.~   "
204743|NCT00881686|"~     Adenosine has been proved to be an important mediator of myocardial protection induced by~     ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can~     provide additional myocardial protection in the setting of pediatric open heart surgery with~     cardioplegia and cardiopulmonary bypass.~   "
204744|NCT00881673|"~     The purpose of the study is to determine whether Al38583 Ophthalmic Solution is safe and~     effective in reducing tear eosinophil levels at 5-8 hours after Conjunctival Allergen~     Challenge (CAC).~   "
204745|NCT00881660|"~     Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and~     leaves a portal through which abdominal structures can migrate into the thorax. In the more~     severe cases, the abdominal structures remain in the thoracic cavity and compromise the~     development of the lungs. Infants born with this defect have a decreased capacity for gas~     exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be~     accurately diagnosed by mid-gestation, a number of strategies have been developed to repair~     the hernia and promote lung tissue development.~      Fetal tracheal occlusion is one technique that temporarily closes the herniated area with the~     Goldvalve balloon to allow the lungs to develop and increase survival at birth. This is a~     pilot study of a cohort of fetuses affected by severe CDH that will undergo FETO to~     demonstrate the feasibility of performing the procedure, managing the pregnancy during the~     period of tracheal occlusion, and removal of the device prior to delivery at BCM/Texas~     Children's Hospital (TCH). It is anticipated that fetal tracheal occlusion plug-unplug~     procedure will improve mortality and morbidity outcomes as compared with current management,~     but this is not a primary endpoint of the feasibility study. We will perform 20 FETO~     procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.~   "
204746|NCT00881647|"~     This study will test the effectiveness of cognitive behavioral therapy for insomnia in~     treating sleep disturbances in people with post-traumatic stress disorder.~   "
204747|NCT00881634|"~     To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine~     Hydrochloride 5 mg/120 mg ER tablets under fed conditions.~   "
204748|NCT00881621|"~     Patients are being asked to participate in this study who have locally advanced or metastatic~     pancreatic cancer (cancer of the pancreas that has spread to another part of the body) that~     has gotten worse after first-line chemotherapy.~      The purpose of this study is to see if the drugs, Capecitabine and Lapatinib (two~     chemotherapy agents), prolong survival and improve quality of life as compared to supportive~     care alone.~      Lapatinib in combination with a drug called capecitabine, has been approved by the Food and~     Drug Administration (FDA) for the treatment of metastatic breast cancer. It has not yet been~     approved to treat this type of cancer. Both of these drugs are pills.~      This research is being done because it is not known if the combination of Capecitabine and~     Lapatinib is better than supportive care alone for pancreatic cancer.~   "
204749|NCT00881608|"~     The purpose of this study is to determine the oral dose level at which the investigative~     drug, Proellex, is able induce menstruation.~   "
204750|NCT00881595|"~     The goal of this study is to evaluate the effects of temozolomide and radiation combination~     in the treatment intended of soft tissue sarcomas.~      This study will also look at the tumor tissue that was removed during your initial biopsy and~     your final surgery for information that may help to treat soft tissue sarcoma in the future.~     In addition the investigators will examine a sample of your normal tissue (optional) from the~     inside of your mouth/cheek (to compare it to your tumor tissue) before starting treatment.~   "
204823|NCT00880633|"~     The purpose of this retrospective study is to determine the degree to which a biliary stent~     affects EUS staging accuracy of ampullary tumors.~   "
204824|NCT00880620|"~     This study examines the efficacy of three doses of IPX066 as compared to placebo in~     Parkinson's disease.~   "
204751|NCT00881582|"~     There is a distinct lack of published literature on the effect of combination treatment of~     PEG-interferon and ribavirin on post-renal transplantation hepatitis C virus (HCV) patients.~     Small case series have been published utilizing conventional interferon and/or ribavirin and~     the available data is extremely preliminary in nature. A small retrospective series of~     patients treated with Pegylated interferon and ribavirin published recently suggests that the~     treatment may be safe and efficacious. Unpublished reports from a few centers within Saudi~     Arabia also suggest a good safety profile and reasonable efficacy from this form of~     combination treatment.~      The investigators aim to prospectively study the safety and efficacy of PEG-interferon and~     ribavirin combination therapy in post-renal transplant HCV-infected patients. Towards this 40~     patients with histological evidence of liver disease will be recruited and the efficacy of~     the above medications studied.~      The proposed study aims to evaluate the efficacy and safety of PEG-interferon and ribavirin~     combination therapy in the treatment of chronic HCV in renal transplant patients in a way~     that will allow management of such patients in an optimized manner.~   "
204752|NCT00881569|"~     This is a study of CS-7017 designed to allow subjects who completed participation in a~     clinical study of CS 7017 without experiencing disease progression or unacceptable toxicity~     to continue treatment with study drug. Subjects who have not progressed while receiving~     CS-7017 will continue to benefit from longer administration of the agent.~   "
204753|NCT00881556|"~     Reduced Intensity Conditioning (RIC) and Allogeneic Stem Cell Transplantation (AlloSCT) from~     family-related donors and unrelated cord blood (UCB) donors will be safe and well tolerated~     in selected patients with RDEB.~      To determine the event-free survival (EFS) and overall survival (OS) following RIC consisting~     of busulfan/fludarabine/alemtuzumab (BFA) and AlloSCT in selected patients with RDEB.~   "
204754|NCT00881543|"~     The purpose of this study is to demonstrate the secretion of glucose, insulin, glucagon,~     C-peptide and lipid profile after isocaloric diets with different nutritional compounds (fat,~     protein and carbohydrate food) in drug näive tipo 2 patients.~   "
204755|NCT00881530|"~     The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2~     different doses compared to Metformin or to Sitagliptin given for 78 weeks in different~     modalities of treatment in patients with type 2 diabetes mellitus.~   "
204756|NCT00881517|"~     The aim of this trial is to verify, under controlled conditions, the reported efficacy of~     human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women~     suffering from primary HCMV infection for the prevention of intrauterine HCMV transmission.~   "
204757|NCT00881504|"~     This study is for patients with biliary tract cancer that has spread and who are not~     candidates for surgical resection.~      The purpose of this research is to determine if bevacizumab can be safely administered with~     Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on~     biliary cancer.~      In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent,~     bevacizumab will be tested.~      Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their~     disease gets worse or they are unable to tolerate treatment.~   "
204758|NCT00881491|"~     The purpose of this study is to determine the treatment outcomes in permanent teeth with~     necrotic pulp and immature root development that undergo a regenerative procedure using a~     triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double~     antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide~     aggregate (MTA) apexification treatment.~   "
204759|NCT00881478|"~     Obesity in children is a serious disease that is associated with increased mortality and~     decreased life expectancy. A simple tool used to assist in controlling portions (and~     therefore calorie intake) at mealtime would be of benefit in promoting weight maintenance~     and/or loss. The purpose of this study is to assess the efficacy of a family intervention~     using a portion control tool to help control weight in obese children. The investigators~     hypothesize that the use of portion control tools by the parents and child will result in a~     greater decrease in the child's BMI over a 6 month period compared with the control group.~   "
204760|NCT00881465|"~     Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric~     obsessive-compulsive disorder (OCD), many people do receive CBT initially. Given this,~     alternative ways of providing CBT need to be identified and tested. With this in mind, the~     proposed study examines the efficacy of a videophone based cognitive-behavioral intervention~     for youth with OCD. A total of 30 youth will be randomly assigned to either videophone~     administered CBT or an abbreviated wait-list control arm. Comprehensive assessments will be~     conducted by trained clinicians at relevant time-points to assess symptom severity and~     impairment.~   "
204761|NCT00881452|"~     The purpose of this study is to determine whether CM-AT is safe and effective in treating the~     core symptoms of autism.~   "
204762|NCT00881439|"~     The main purpose of this study is to examine the effect of add-on therapy with the direct~     renin inhibitor Aliskiren in comparison to placebo on renal blood flow in patients with heart~     failure and reduced renal function.~        -  Primary outcome measure: change in renal blood flow at 6 months~        -  Secondary outcome measures: changes in renal function, N-terminal pro Brain natriuretic~          peptide, left ventricular function, blood pressure and neurohormones~   "
204763|NCT00881426|"~     To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting~     conditions.~   "
204764|NCT00881413|"~     The aim of this study is to compare the clinical effectiveness of intravenous esomeprazole~     and pantoprazole in preventing recurrent bleeding in the patients with high-risk bleeding~     peptic ulcers after successful standard endoscopic hemostasis.~   "
204765|NCT00881400|"~     To demonstrate the relative bioavailability of Cefzil 250 mg/5 ml oral suspension fed~     conditions.~   "
204766|NCT00881387|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as~     gemcitabine and vinorelbine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving rituximab together with~     gemcitabine and vinorelbine may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine~     and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not~     responded to treatment.~   "
204768|NCT00881361|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed.~      PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and~     axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage~     IIIB breast cancer.~   "
204769|NCT00881348|"~     Primary Objective:~      To demonstrate the absence of photo irritation and photosensitization potential of the~     product Dermacyd Infantile (Lactic Acid).~   "
204770|NCT00881335|"~     The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus~     clearance devices in elders of gerocomium.~   "
204771|NCT00881322|"~     This is a randomized, double-blind, placebo-controlled trial to determine the safety and~     efficacy of Digestive Advantage™ Gas Defense formula, a probiotic dietary supplement. The~     study will last approximately four weeks, and subjects will be seen at a~     screening/randomization visit, and two follow-up visits.~      Study procedures will include administering questionnaires for assessment of the study~     product's effect on intestinal gas symptoms and quality of life.~   "
204772|NCT00881309|"~     The purpose of this study is to:~        -  To access the efficacy of TW compared to Aza in the maintenance therapy for lupus~          nephritis~        -  To investigate the safety and tolerability of TW versus Aza in the maintenance therapy~          for lupus nephritis~   "
204773|NCT00881296|"~     A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly~     gemcitabine in elder patients (> 75) with previously untreated advanced non-small cell lung~     cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST~     criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly~     single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (>~     76 years) who have received no prior treatment for non-small lung cancer. As secondary~     objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin~     combination chemotherapy, progression-free survival and overall survival will be evaluated in~     both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly~     single gemcitabine.~      The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus~     carboplatin may improve the efficacy.~   "
204774|NCT00881283|"~     The purpose of this study is to determine whether subjects who have been affected by~     Cushing's disease in the past maintain some different characteristics compared with subjects~     who have never been diagnosed with the disease.~   "
204775|NCT00881270|"~     Primary Objective:~      To prove the safety of the formulation in normal conditions of use.~   "
204776|NCT00881257|"~     The objective of this clinical investigation is to evaluate the safety and efficacy of the~     Minnow Medical GRST™ Peripheral Catheter System in the treatment of de novo lesions in the~     superficial femoral artery (SFA) or the popliteal artery.~   "
204777|NCT00881244|"~     A Phase I open label study of AS1411 in advanced solid tumours. Objectives include~     determining the MTD and DLT of AS1411, to determine the PK profile of AS1411 and to obtain~     preliminary evidence of clinical and biological responses to AS1411 therapy.~   "
204778|NCT00881231|"~     To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting~     conditions.~   "
204779|NCT00881218|"~     This is a pilot study to determine whether the drug regadenoson can be used during magnetic~     resonance imaging to assess regions of poor blood flow to the heart.~      The hypothesis of this study is that a single injection of regadenoson could be used instead~     of a standard adenosine infusion to produce coronary vasodilatation and demonstrate~     myocardial ischemia during first-pass perfusion cardiac MRI.~   "
204780|NCT00881205|"~     This study evaluated the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in~     cognitively impaired Multiple Sclerosis (MS) patients. Primary objective was the assessment~     of cognition by the Selective Reminding Test (SRT) -a subtest of the brief repeatable battery~     (BRB) - after titration of 4 weeks and maintenance of 12 weeks. This double-blind period was~     followed by a 52-week open-label treatment phase to assess long-term safety of rivastigmine~     patch in these patients.~   "
204781|NCT00881192|"~     Since its first introduction in humans in 1962, Intra-Aortic Balloon Pump (IABP) is now the~     most commonly used therapeutic option to support failing heart in cardiac surgery. The main~     effects of IABP are an increase in diastolic blood pressure and therefore an improvement in~     coronary perfusion and a reduction of ventricular after load, thus increasing stroke volume~     and cardiac output. IABP-related complications include limb ischemia, bleeding at the site of~     IABP insertion, infection, and aortic dissection.~      IABP could be used preoperatively, intraoperatively, or postoperatively. However, despite the~     wide use of the device, the optimal timing and use of IABP in high-risk patients undergoing~     cardiac surgery remains controversial. Time of insertion has been showed to affect hospital~     mortality, ranging from 18.8% to 19.6% for preoperative insertion, from 27.6% to 32.3% for~     intraoperative insertion, and from 39% to 40.5% for postoperative insertion. Several studies,~     randomized and non-randomized, have been conducted to address the impact of preoperative use~     of IABP on the outcome, each study including a relative small number of patients. In an~     effort to increase the strength of the results, two meta-analysis have been conducted and~     published in 2008. The objectives of both were to assess the effect on mortality and~     morbidity of using IABP preoperatively in high-risk patients undergoing coronary artery~     bypass grafting (CABG). Surprisingly, the meta-analysis from Field and co-workers was~     conducted on four randomized controlled trials (for a total of 193 patients included)~     published by the same author from the same institution, making the results not conclusive~     although favourable toward a beneficial effect of the preoperative use of IABP. Moreover, two~     of the randomized trials conducted by Christenson and co-workers and included in the above~     mentioned meta-analysis, were excluded from the meta-analysis from Dyub and co-workers~     because considered duplicates. Unfortunately, one study by Christenson and co-workers and~     included in the meta-analysis from Dyub was conducted on off-pump surgery, introducing~     another bias in the criteria of eligibility.~      At present it is unclear whether the preoperative use of IABP in high-risk coronary patients~     scheduled for CABG operations leads to a better outcome. The experimental hypothesis of the~     present randomized, controlled trial (RCT) is that the placement of IABP immediately before~     beginning the surgical procedure induces a reduction of major morbidity after the operation.~   "
204782|NCT00881179|"~     To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting~     conditions.~   "
204783|NCT00881166|"~     Adult subjects with malignant disease appropriate for treatment with carboplatin/paclitaxel,~     carboplatin/etoposide, topotecan, docetaxel or erlotinib according to the standard dosing~     regimen will be enrolled in each treatment arm.~      Primary objective: Determine the MTD.~      Secondary objectives: Response rates, PK, quantify MP-470 on PK of SOC, and collect~     pharmacodynamic information. Evaluate the overall safety of MP-470 when co-administered with~     specific SOC treatments.~   "
204784|NCT00881153|"~     The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5~     ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.~   "
204787|NCT00881114|"~     This is a study for patients with head and neck cancer who will be receiving chemotherapy and~     radiation therapy for their disease. The purpose of this study is to see if the investigators~     can use genetic differences between patients to select the right drug to use with radiation~     therapy. This type of genetic testing is called pharmacogenetics.~      Currently there are two drugs used to treat head and neck cancer that have provided a benefit~     when given with radiation compared to radiation alone in previous studies. These two drugs~     are cisplatin and cetuximab (Erbitux).~      In this trial, the investigators will test whether genetic differences between patients can~     be used to pick which drug they should receive. A recent study that looked back to see how~     well patients with head and neck cancer responded to treatment with cisplatin showed that~     genetic differences in a few genes were associated with who did and who did not survive their~     cancer. The investigators are taking that finding and using it to test patients for these~     genetic differences to determine whether they should receive cisplatin or cetuximab. In other~     words, the investigators are trying to take what is essentially a flip of the coin choice~     between these two drugs, and instead use individual patient's genetic differences to make-and~     hopefully improve- this choice.~   "
204788|NCT00881101|"~     The purpose of this study is to determine the maximum tolerated dose and dose limiting~     toxicities of liposomal paclitaxel in Chinese patients with solid tumors in advanced stages.~   "
204789|NCT00881088|"~     Objective:~      The purpose of this study is to determine the need for thromboprophylaxis in patients with a~     fracture of the lower extremity being treated conservatively in a below-knee plaster cast and~     to assess if both of the two tested prophylactic treatments are effective for this~     indication.~      Hypothesis:~      Nadroparine and Fondaparinux are both effective in preventing a thromboembolic event in~     patients with a nonsurgical fracture of a lower extremity immobilised in a below-knee plaster~     cast.~   "
204790|NCT00881075|"~     This study will examine the safety and effectiveness of a manganese-based agent called~     SeeMore (EVP 1001-1 Injection) for enhancing magnetic resonance imaging (MRI) in patients who~     have previously had a heart attack. It will determine whether SeeMore makes it easier to find~     damaged areas of the heart and will evaluate how well patients feel and how their bodies~     react after receiving the study medication.~      Adult patients who have previously had a heart attack and are in stable health may be~     eligible for this study. Candidates are screened with a medical history, a brief physical~     examination and blood and urine tests.~      Participants undergo the following procedures:~        -  Collection of blood and urine samples 24 hours before receiving SeeMore and 24 hours~          after. A blood sample is also taken 3 and 10 days after receiving the drug.~        -  MRI scans one hour before receiving SeeMore and 10 minutes after receiving the drug. MRI~          uses a magnetic field and radio waves to produce images of body tissues and organs.~          After the first (baseline) MRI is done, SeeMore is given intravenously (through a vein)~          and the subject's vital signs and electrocardiogram (EKG) are monitored for 10 minutes.~          Then the second MRI is done to determine whether the study medication makes it easier to~          see areas of the heart that were affected by the heart attack.~        -  Check of vital signs, EKG and physical examination after the second MRI.~   "
204791|NCT00881062|"~     This study was to determine the ADME and metabolites of Proellex following a single oral dose~     of 25 mg.~   "
204792|NCT00881049|"~     This study is a single-armed, open-label, single-center phase II trial of signal transduction~     inhibitor number 571 (STI-571) systemic therapy in selective patients with metastatic~     melanoma, and aims to study the efficacy and safety. The primary endpoint is progression-free~     survival (PFS) and the second endpoints are overall response rate (ORR), overall survival~     (OS), 1-year OS and safety.~   "
204793|NCT00881036|"~     Individuals with resolved hepatitis B, characterized as hepatitis B surface antigen~     (HBsAg)-negative and hepatitis B core antibody-positive, have latent hepatitis B virus (HBV)~     infection in their liver tissue. Cytotoxic chemotherapy and hematopoietic stem cell~     transplantation sometimes trigger the reactivation of latently infected HBV, resulting in de~     novo hepatitis B. Although de novo hepatitis B could cause acute liver failure or chronic~     hepatitis, an effective management strategy for de novo hepatitis B has not been well~     established. Risk factors and effective management for de novo hepatitis B will be clarified.~   "
204794|NCT00881023|"~     The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment~     of damaged knee cartilage using the subject's own healthy cartilage obtained from a~     non-weight or low weight-bearing region. CAIS is indicated for the repair of articular~     cartilage lesions and osteochondritis dissecans (OCD) of the knee through cartilage~     regeneration.~   "
204795|NCT00881010|"~     The goal of this psychosocial research study is to learn about treating pain and other~     symptoms of minority patients who have breast cancer. The study will test how well a special~     telephone system works for improving the pain and symptom management of these patients.~   "
204796|NCT00880997|"~     Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in~     humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse~     among cocaine dependent participants.~   "
204797|NCT00880984|"~     Purpose:~      Evaluation of the CAR™ 27 for the creation of compression anastomoses.~      Indication:~      Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during~     colonic or colorectal resection.~      Study Design:~      Prospective, open labeled study.~      Patient Population:~      Male or female subjects 18 years of age or older who are scheduled for non emergency~     laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy~     can be preformed up to the discretion of the surgeon.~      No. of Subjects:~      15 patients estimated up to three months to enroll.~      Duration of Treatment:~      During the operation - creation of the anastomosis.~      Duration of Follow-up:~      Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic~     visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone~     after 3 months.~      Endpoints:~      To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse~     events related to the use of the CAR™ 27 device.~   "
205119|NCT00876707|"~     The purpose of this study is to determine if differences in the design of multifocal~     intra-ocular lenses would mean different values of higher-order aberrations and different~     performance in objective parameters such as modulation transfer function.~   "
204798|NCT00880971|"~     Several important international randomized trials have shown that postoperative chemotherapy~     contributed to the improvement on 5 year survival rate by about 4% for patients with~     non-small cell lung cancer after complete resection. But the overall survival rate was~     relatively low and the local recurrence was still the dominant failure pattern for stage IIIA~     (N2) disease even these patients received the postoperative chemotherapy. Several~     meta-analyses have shown that postoperative radiotherapy has no effect on the survival~     improvement for patients with non-small lung cancer after complete resection. However,~     sub-group analysis based on the same dataset of these meta-analyses showed that the~     postoperative radiotherapy with conventional radiotherapy might be beneficial for stage IIIA~     (N2) disease. The 3D conform radiotherapy can increase the radiation dose to the target~     volume while decreasing the dose to risk organs comparing with the conventional radiotherapy.~     So it is expected that postoperative 3D conform radiotherapy after postoperative chemotherapy~     will improve the local control and overall survival rate for stage IIIA (N2) non-small cell~     lung cancer. Here, the investigators designed a phase III randomized trial to compare the~     three years overall and disease free survival rate in patients with completely resected stage~     IIIA (N2) non-small cell lung cancer who receive the chemotherapy alone or the chemotherapy~     plus 3D conform radiotherapy.~   "
204799|NCT00880958|"~     The purpose of this study is to determine the effect of supplement combined various~     probiotics and fermentation products on body mass index, body fat mass, abdominal~     circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in~     overweight subjects.~   "
204800|NCT00880945|"~     The aim of this study is to evaluate if Electromagnetic navigation (ENB) in combination with~     rapid on site evaluation (ROSE) can improve diagnostic accuracy in those patients who fail to~     be diagnosed with conventional fluoroscopic assisted bronchoscopy (FBS) in combination with~     ROSE.~   "
204801|NCT00880932|"~     The hypothesis is that a newly formatted electronic alert that requires the prescriber to~     pause and enter a specific reason for override on this alert, will cause prescribers in the~     intervention group to be significantly less likely to prescribe the combination of warfarin~     and NSAID than prescribers in the control group.~   "
204802|NCT00880919|"~     The Primary objective of this study is to evaluate Seroquel XR in the treatment of borderline~     personality disorder (BPD). As in many initial randomized control trials, the study will be~     of relatively short duration - 8 weeks - to assess effectiveness and safety while maximizing~     retention. The specific aim is to determine if Seroquel XR is superior to placebo. The~     primary outcome measure will be a statistically significant difference between Seroquel XR~     compared to placebo on the Zanarini Rating Scale for Borderline Personality Disorder~     (ZAN-BPD), an objective rating scale that addresses the severity of Diagnostic and~     Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of the illness. As~     there is the recent development of an extended release form of Seroquel (Seroquel XR) (Schulz~     et al. 2007), the new compound may offer several advantages in this study. Therefore, the~     hypothesis of this study is that both doses of Seroquel XR (see below) will be superior to~     placebo in an 8-week randomized trial as assessed by the ZAN-BPD.~      To achieve the Primary Objective of this study, two doses of Seroquel XR will be tested - 150~     mg/d and 300 mg/d. Thus, the study will be able to assess the effect of Seroquel XR compared~     to placebo and to explore a dose effect.~   "
204803|NCT00880906|"~     This study is for patients who have had a food impaction and/or difficulty swallowing, who~     are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the~     esophagus.~      Standard treatment for people who have food impaction and difficulty swallowing is endoscopy~     to view the esophagus, tissue biopsies of the lining of the esophagus for diagnosis, and drug~     therapy including steroids and drugs used to treat reflux disease. Early dilatation or~     stretching of the esophagus may be done at this time but not always. Some doctors prefer to~     wait and see if the drugs are affective.~      It is not known if dilating the esophagus early in treatment adds benefit. Therefore, we are~     doing this study to compare the two methods of treatment. We will compare two groups: one~     group will have dilatation performed during the first endoscopy and one group will not have~     dilatation performed during endoscopy. We will see if dilatation helps prevent food impaction~     and improves swallowing.~      Another purpose of this study is to learn more about the causes of swallowing problems, thus~     extra biopsies will be taken of the esophagus and store them for future research.~   "
204804|NCT00880893|"~     Primary Objectives:~        -  To evaluate safety after each CYD Dengue vaccination.~        -  To evaluate the immune response to each CYD Dengue serotype after each vaccination in a~          subset of subjects.~   "
204805|NCT00880880|"~     The overall goal of this study is to test whether an electronic pelvic floor questionnaire~     (e-PAQ-PF) will increase discussion rates of incontinence in a primary care setting.~   "
204806|NCT00880867|"~     The primary objective of this study is to evaluate the safety of intratumoral~     Polyinosinicpolycytidylic acid stabilized with polylysine and carboxymethylcellulose~     (poly-ICLC)(Hiltonol®) in addition to low-dose local radiotherapy for adult patients with low~     grade lymphomas, including follicular lymphoma, marginal zone lymphoma, small lymphocytic~     lymphoma, chronic lymphocytic leukemia, and cutaneous T-cell lymphoma. The secondary~     endpoints are response rate, immune responses, and durability of responses as well as~     generation of antiinflammatory response at sites of tumor involvement.~   "
204807|NCT00880854|"~     The purpose of this study is to find out the highest safe dose of the investigational drug~     CP-675,206 when given in combination with BCG therapy to patients who have experienced~     recurrent superficial bladder cancer after standard BCG treatment.~      In addition, the study will look to see if taking CP 675,206 generates an immune response and~     evaluate how the drug affects superficial bladder cancer.~   "
204808|NCT00880841|"~     A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg~     Buprenorphine/Naloxone.~      NIDA Contract No. HHSN271200577414C~   "
204809|NCT00880828|"~     The primary objective of the study is to investigate the efficacy of device with far-infrared~     (FIR) irradiation in these patients with acute cervical radiculopathy.~   "
204810|NCT00880815|"~     The goal of this clinical research study is to learn if bendamustine, when given with a stem~     cell transplant and chemotherapy (fludarabine and rituximab), can help the transplanted stem~     cells start to grow and make new blood cells in patients with leukemia and lymphoma. The~     safety of this combination will also be studied.~   "
204811|NCT00880802|"~     Study Objectives~      The following items will be prospectively assessed.~      Primary Endpoints~        1. For patients presenting with clinical suspicion of Acute Coronary Syndromes (ACS), high~          sensitivity-cardiac Troponin I (hs-cTnI) provides improved diagnostic accuracy for ACS~          (including Acute Myocardial Infarction (AMI) and/or Unstable Angina (UA)) within the~          first two (2) hours after emergency department presentation when compared to currently~          available troponin assays.~        2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved~          prognostic information with regard to 180 day event rates of Major Adverse Cardiac Event~          outcomes, including cardiac deaths which are defined as all deaths except those that are~          clearly non-cardiac in nature (e.g. trauma), when compared to a currently available~          troponin assay.~      Secondary Endpoints~        1. For patients presenting with clinical suspicion of ACS, using the rate of rise of~          hs-cTnI over time between presentation and 2 hours (delta hs-cTnI) allows for the~          differentiation between ACS and other disease states.~        2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved~          sensitivity for detecting AMI within the first two (2) hours after presentation when~          compared to a currently available troponin assay.~        3. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved~          negative predictive value for ruling out ACS (AMI or UA) within the first 2 hours after~          presentation when compared to a currently available troponin assay.~        4. For alternative endpoints of cardiac mortality, and for alternative censor time points~          of 30 days, 90 days, and 1 year, hs-cTnI provides improved prognostic information when~          compared to the currently available troponin assay.~        5. In cases where the emergency physician has limited diagnostic confidence, hs-cTnI AMI~          diagnostic accuracy will be superior to local hospital standards for AMI determination.~        6. In cases where the emergency physician has limited diagnostic confidence, the slope for~          the hs-cTnI between presentation and 2 hours will add diagnostic accuracy for ACS~          diagnosis over and above local hospital standards for ACS determination.~        7. For patients presenting with clinical suspicion of ACS, the difference in diagnostic~          accuracy for ACS (including AMI and/or UA) using hs-cTnI measurement from time of onset~          of symptoms to emergency department presentation (e.g. 3 hours instead of 6 hours) will~          be evaluated to assess any variation.~   "
204812|NCT00880789|"~     With this study, we want to see if we can use a kind of white blood cell called T cells to~     prevent or treat AdV and CMV infection. We will grow these T cells from the cord blood before~     the patients transplant. These cells have been trained to attack adenovirus/CMV-infected~     cells and are called Adenoviral/CMV-specific cytotoxic (killer) T-cells or AdV/CMV-CTL. We~     would plan to give the patient one dose of AdV/CMV-CTL any time from 30 days after their~     transplant. We have used T cells made in this way from the blood of donors to prevent~     infections in patients who are getting a bone marrow or blood stem cell transplant but this~     will be the first time we make them from cord blood.~   "
204813|NCT00880763|"~     The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with~     Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C~     infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid~     viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in~     the placebo group, when each is administered concomitantly with pegylated interferon~     (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated~     compared with placebo, when each is administered concomitantly with peg-IFN α-2a and~     ribavirin for 28 days.~   "
204814|NCT00880750|"~     This study is being conducted to assess any potential differences in the absorption and~     excretion between two lanthanum carbonate formulations. This study is also being done to~     assess the safety and tolerability of the two lanthanum carbonate formulations.~   "
204815|NCT00880737|"~     The objectives of the PROTECT study are:~        -  To assess the role of CT pulmonary angiography in the risk stratification of~          hemodynamically stable patients with acute symptomatic pulmonary embolism (PE).~        -  To assess the role of transthoracic echocardiography in the risk stratification of~          hemodynamically stable patients with acute symptomatic PE.~        -  To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk~          stratification of hemodynamically stable patients with acute symptomatic PE.~        -  To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk~          stratification of hemodynamically stable patients with acute symptomatic PE.~        -  To assess the combined role of CT pulmonary angiography, transthoracic echocardiography,~          PESI, troponin I and brain natriuretic peptide in the risk stratification of~          hemodynamically stable patients with acute symptomatic PE.~   "
204816|NCT00880724|"~     The objective of this randomized, blinded, multicenter, controlled study is to compare the~     performance of the IBV Valve System (treatment group) to a control group receiving a sham~     bronchoscopy procedure without valve placement.~   "
204817|NCT00880711|"~     The purpose is to collect real life data on the use of fulvestrant in normal clinical~     practice in Austria and document the clinical benefit of fulvestrant treatment.~   "
204818|NCT00880698|"~     Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting~     for 45% of severe diarrhea disease in both developed and developing countries. Annually,~     rotavirus causes approximately 111 million episodes of gastroenteritis requiring home care,~     25 million clinic visits, 2 million hospitalizations, and approximately 440,000 deaths in~     children less than 5 years of age, of which approximately 90% of hospitalizations and 99% of~     deaths occur in developing countries. Although rotavirus infection is not more common in~     HIV-infected children, it complicates their care and interferes with their nutrition. Chances~     of death by these infections can be greater in HIV-infected children when they also suffer~     from wasting, malnutrition, and/or opportunistic infections. The primary purpose of this~     study was to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate,~     RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.~   "
204819|NCT00880685|"~     The goal of the proposed study is to evaluate the efficacy and safety of memantine in~     kleptomania.~   "
204820|NCT00880672|"~     The purpose of this study is to determine whether dutasteride may influence the expression of~     angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial~     growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic~     hyperplasia (LUTS/BPH).~   "
204821|NCT00880659|"~     The next influenza pandemic is expected to spread rapidly in resource-poor settings.~     Influenza viruses spread from human-to-human via large respiratory droplets. Transmission via~     large-particle respiratory droplets is believed to be mediated by close contact between~     infected and susceptible persons or contact with droplet-contaminated fomites. Close contact~     between infected and susceptible persons may consist of skin-to-skin contact (e.g., via~     hands) or inhalation of respiratory droplets (e.g., due to talking, coughing, or sneezing by~     the infected person). Airborne transmission, which is expected to result in transmission over~     long distances (>1 meter) and which would be mediated by ventilation, is believed to be~     uncommon. Therefore, the greatest risk of transmission from personal contact comes from those~     people who are closest to an index case, such as contacts living in the same household. There~     are, to date, no published estimates of the secondary attack ratio of influenza among~     household contacts of index case-patients in low-income countries. Moreover, the~     investigators do not have data on the risk factors for secondary transmission of influenza~     from index case-patients to their household contacts. There is some data for the benefits of~     promoting handwashing with soap on the risk of all-cause acute respiratory illness among~     children < 15 years old in a resource-poor setting in Pakistan. But, the investigators do not~     have evidence that promoting handwashing with soap will acutely reduce the risk of secondary~     transmission. Therefore, the investigators propose to conduct a study in rural Bangladesh to~     assess the following:~        -  The secondary attack ratio of influenza among household contacts of an index~          case-patient with influenza~        -  The risk factors for secondary transmission of influenza from an index case-patient to~          household contacts~        -  The impact of promoting handwashing with soap on the risk of secondary transmission of~          influenza from an index case-patient to household contacts~        -  The impact of handwashing promotion on handwashing behavior six months after~          intervention~        -  The impact of handwashing promotion on the prevalence of respiratory infections,~          diarrhea and influenza~   "
204822|NCT00880646|"~     This study aims to investigate the effect of supplement containing L-arabinose and~     indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat~     mass, and serum biochemical parameters in overweight subjects.~   "
204825|NCT00880607|"~     This study plans to learn more about preventing pain in children who are having posterior~     spinal fusion surgery using two different kinds of morphine (a pain medicine). Also, this~     study plans to learn about individual differences in the how the different kinds of morphine~     work in children.~      Subjects are being asked to be in this research study because they are having spinal fusion~     surgery, will have pain some of the time and will be getting morphine during and after~     surgery to help control their pain.~   "
204826|NCT00880594|"~     Individuals with irritable bowel syndrome (IBS) may experience abdominal pain as a result of~     pain signals in the bowel and how these signals are processed in the brain. Studies using~     brain imaging (pictures) have shown that IBS patients with more pain diagnoses (i.e.~     fibromyalgia, migraines, etc.) have greater activity in the regions of the brain responsible~     for the emotional and thought processing of pain signals. This could possibly make bowel~     sensations and bowel difficulties feel abnormal or more noticeable, in turn causing more~     severe IBS symptoms. The purpose of this protocol is to explore the role of pain diagnoses~     and their affect on brain activity in IBS patients. The investigators will also examine the~     use of a medication, desipramine, which is known to affect these brain regions, in IBS~     patients.~   "
204827|NCT00880581|"~     To assess the feasibility of using intra-tumoral PF-3512676 in combination with local~     radiation as a therapy for lowgrade b-cell lymphoma.~   "
204828|NCT00880568|"~     This study determines recommended clinical dose, to evaluate the safety, tolerability and~     pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors~     who have failed standard therapy or for whom no standard therapy exists, in two dosing~     schedules in Japan.~   "
204829|NCT00880555|"~     Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops.~     Dementia is considered to be present when a person can no longer handle complex activities of~     daily living, such as managing finances. This study will investigate the relationship between~     changes in the ability to manage finances and brain perfusion, which will be measured using~     continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo~     neuropsychological tests focusing on several types of memory and thought process, with~     special emphasis on semantic memory. An important question to be addressed is whether changes~     in function are better predicted by the neuropsychological tests or by the brain scan.~   "
204830|NCT00880542|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as ifosfamide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving sorafenib together with~     ifosfamide may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with~     ifosfamide and to see how well it works in treating patients with high-grade soft tissue~     sarcoma or bone sarcoma that can be removed by surgery.~   "
204831|NCT00880529|"~     The purpose of this study is to find out if patients having the ON-Q post-op Pain Relief~     System for pain management of multiple rib fractures will require fewer ventilator days, and~     will need less IV pain medicine to control their pain, and as a result have improved~     respiratory function during their recovery.~      The standard of care for providing pain relief for rib fractures is to use an opioid drug~     that is injected into the vein but also has side effects. Increased doses can lead to over~     sedation and consequently lead to difficulty with breathing. The ON-Q pain relief systems~     uses a local anesthetic under the skin. The anesthetic is called bupivicaine, and it is~     delivered from a thin tube approximately 10 inches long is tunneled under the skin along the~     back and parallel to the spine. The medication is stored in an elastic pump which delivers a~     slow continuous drip of medication from multiple holes in the tubing. Subjects will be~     randomized to either standard intravenous opioid pain management or the ON-Q pain relief~     device with supplemental opioid medication if needed. The device will remain in use until the~     subjects are able to breathe without the ventilator.~   "
204832|NCT00880516|"~     The purpose of this study is to learn more about the genetics of chronic sinusitis and~     identify genes involved in chronic sinusitis.~   "
204833|NCT00880503|"~     Background:~      Resistance to cancer chemotherapy develops in patients, rendering certain treatments~     ineffective. Despite much research, the prevailing cause of drug resistance is not known.~      One mechanism for drug resistance involves a protein called P-glycoprotein, or Pgp, which~     reduces the effectiveness of cancer treatments by pumping anti-cancer drugs out of tumor~     cells where they are supposed to work against the disease.~      Objectives:~      To identify and evaluate more thoroughly the roles of Pgp and other substances in mediating~     drug resistance.~      Eligibility:~      Patients enrolled in clinical trials of cancer therapies at the Children's Hospital of~     Pittsburgh; Cancer Centers of Carolinas; Arizona Clinical Research Center; University of~     Copenhagen; and Herlev Hospital, Copenhagen who have consented to the use of blood, tissue,~     or tumor samples for laboratory studies.~      Design:~      Blood, tumor, and tissue samples are collected from participants and sent to the NCI for~     various laboratory analyses.~   "
204834|NCT00880490|"~     The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to~     placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe~     chronic obstructive pulmonary disease (COPD).~   "
204835|NCT00880477|"~     This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's~     DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV~     according to a three-dose immunisation course and as a booster dose in infants born to~     hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV~     vaccine.~   "
204836|NCT00880464|"~     The purpose of this trial is to test the safety of a vaccine made from a patient's own breast~     cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The~     vaccine is made by genetically modifying a patient's own tumor cells to secrete~     granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response~   "
205120|NCT00876694|"~     This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in~     Japanese patients with moderate to severe COPD. Data from this study will be used for the~     registration of indacaterol in Japan.~   "
205996|NCT00865085|"~     The purpose of this study is to evaluate and compare the relative bioavailability, and~     therefore the bioequivalence of two formulations of Citalopram after a single dose~     administration under fasting conditions.~   "
204837|NCT00880451|"~     The protocol objectives are to enable prospective IRB review of research using human MRI~     scans and data collected under other branch protocols or extramural sources. By combining~     data from multiple sources the investigators will be able to conduct analyses that require~     large numbers of observations that exceed the numbers collected in any single study. They~     will also be able to stratify and subgroup the combined samples in different ways to permit~     analyses that would otherwise not be possible. The study population consists of normal~     individuals and clinical groups of all ages. Clinical groups will be added by amendment~     including patients suffering from schizophrenia, ADHD, autism, Klinefelter's disease, and~     Alzheimer's disease. The study design consists of 1) automated segmentation of MRI brain~     scans to obtain regional measurements of cortical thickness and volumetric measurements of~     brain structures including basal ganglia, 2) manual segmentation of brain structures and~     brain anomalies not amenable to automated segmentation such as Virchow-Robbins spaces, 3)~     correlation analyses between MRI brain measurements and available demographic (e.g. gender)~     and physiological (e.g. BMI) data, statistical analysis of group differences where the groups~     are defined by diagnosis, age, gender or by other potentially useful classification. Since~     all data were collected under other protocols there are no additional risks or benefits~     associated with this protocol. This protocol combines MRI data from disparate sources and can~     provide important information regarding factors that may affect the comparability of MRI~     scans obtained from different sites using various types of MRI scanners and pulse sequences~     to generate MRI images. It will also enable the analysis of specific subgroups with~     sufficient numbers of observations for meaningful statistics....~   "
204838|NCT00880425|"~     The objective of this study is to determine if patients with chronic daily headache have~     continuous headache or moments of headache relief. The secondary objective of this study is~     to determine the period of time patients who have chronic daily headache that is not~     continuous are headache free.~   "
204839|NCT00880412|"~     The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in~     addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.~   "
204840|NCT00880399|"~     This is a 6-week, randomised, multicenter, double-blind, placebo controlled, fixed dose~     parallel group study to assess the efficacy and safety of orvepitant (30 and 60 mg/day)~     versus placebo in subjects with a diagnosis of a Major Depressive Disorder, whose symptoms~     are considered moderate or severe.~      Following an initial screening visit, subjects fulfilling the study inclusion and exclusion~     criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory~     and ECG assessments and to confirm eligibility for inclusion into the study. This screening~     phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the~     screening period, eligible subjects will be randomised at the baseline visit to receive~     either orvepitant 30mg/day, orvepitant 60mg/day or placebo (equal chance of receiving any of~     the three possible treatments, i.e., a 1:1:1 ratio) for a six-week double-blind treatment~     phase. Those subjects randomised to receive placebo will receive study medication identical~     in appearance to that received by subjects assigned to receive orvepitant 30 or 60mg/day.~      Efficacy will be assessed via standard depression symptom and severity rating scales or~     questionaires. The Hamilton Depression Rating Scale (HAM-D) will be used as the primary~     measure. Secondary efficacy endpoints include the Quick Inventory of Depressive~     Symptomatology (QIDS-SR) and the Clinical Global Impression- Global Improvement and Severity~     of Illness Scale (CGI-I and CGI-S, respectively).~      Safety will be assessed by monitoring for adverse events (side effects) and through periodic~     laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart~     rate, temperature) and heart function measurements (electrocardiograms, or ECGs).~   "
204841|NCT00880386|"~     RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by~     radiation therapy in patients with non-small cell lung cancer.~      PURPOSE: This clinical trial is studying losartan to see how well it works in treating~     pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage~     III non-small cell lung cancer.~   "
204842|NCT00880373|"~     The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through~     patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in~     adults with sickle cell disease (SCD).~   "
204843|NCT00880360|"~     This study tests whether denileukin diftitox will deplete regulatory T cells, boost~     tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or~     who are ineligible for front line therapy.~   "
204844|NCT00880347|"~     The objective of the study is to define the performance of blood-based signatures for~     Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and~     non-demented controls.~   "
204845|NCT00880334|"~     In this research study the investigators are looking to see if the combination of docetaxel~     plus Vandetanib is effective in the treatment of metastatic transitional cell carcinoma~     (TCC). Docetaxel is a chemotherapy drug that kills cancer cells that are dividing. It is~     widely used in TCC. Vandetanib is a drug that is believed to stop new blood vessels from~     forming around cancer cells. The combination of docetaxel and Vandetanib has been studied in~     people with lung cancer and found to be helpful in killing cancer cells. Thus, this study is~     looking at people with TCC, to see if the combination of docetaxel plus Vandetanib is better~     or worse then docetaxel alone.~   "
204846|NCT00880321|"~     BRF112680 is a first-time-in-human study to establish the recommended dose and schedule of~     the orally administered GSK2118436. The recommended dose and regimen will be selected based~     on the safety, pharmacokinetic, and pharmacodynamic profiles observed after the treatment of~     subjects with solid tumors. This is a two-part study. Part 1 will identify the recommended~     Part 2 dose using a dose-escalation procedure. Escalation may proceed until either a maximum~     tolerated dose is established, or the toxicokinetic safety limit is reached. The recommended~     Part 2 dose will be expanded to up to 12 patients. Part 2 will explore further the safety,~     tolerability, and clinical activity of GSK2118436 in subjects with BRAF mutation-positive~     tumors. In addition, the effect of GSK2118436 on midazolam will be assessed in a subset of~     patients in Part 2. Biologically active doses will be identified by measurement of~     pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may~     be explored in Part 2.~   "
204847|NCT00880308|"~     This first-in-human dose-escalation study is to characterize the safety, tolerability,~     pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in~     patients with advanced solid tumors.~   "
204960|NCT00878813|"~     Prospective observational multicenter study to evaluate copeptin as a prognostic marker in~     patients with an acute cerebrovascular event. It includes four groups of patients, mainly~     depending on type of initial therapy (intra-arterial thrombolysis, intravenous thrombolysis,~     conservative treatment, TIA). The study takes place at the Emergency and neurological~     Department of the University of Bern, Switzerland; Department of Neurology, Goethe University~     of Frankfurt a.M. (Germany). Further participating centers are under discussion~   "
204848|NCT00880295|"~     Although some surgeons prefer one technique rather than the other, both endoscopic and open~     carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal~     tunnel syndrome. The investigator's research is designed to evaluate the significant~     difference in patient satisfaction between endoscopically-released wrists and open-released~     wrists. The goal of the study is to compare the two techniques using the following criteria:~        1. Primary outcome: patient satisfaction via surveys used in prior publications~        2. Secondary outcome: length of time to return to work~        3. Secondary outcome: clinical data for recovery from carpal tunnel syndrome including a~          thorough physical exam and EMG's~        4. Secondary outcome: complication rates~   "
204849|NCT00880282|"~     This phase I trial is studying the side effects and best dose of cixutumumab when given~     together with temsirolimus in treating younger patients with solid tumors that have recurred~     or not responded to treatment. Monoclonal antibodies, such as cixutumumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
204850|NCT00880269|"~     This study was to evaluate the efficacy and safety of single agent oral panobinostat in~     patients who have refractory de novo or refractory secondary AML.~   "
204851|NCT00880256|"~     Irritable bowel syndrome (IBS) is a very common, chronic disorder that significantly affects~     quality of life, and results in enormous expenditures each year in the United States. Therapy~     for IBS is generally unsatisfactory, and takes an additive approach whereby medications are~     prescribed according to each type of symptom the patient experiences. Accumulating evidence~     indicates that persons with IBS have a heightened perception of stress, and chronic stress~     has been shown to have a significant impact on IBS symptomatology. Mindfulness involves the~     ability to bring attention to the present moment without judgment; this ability is correlated~     with measures of mental health and decreased stress perception. The clinical literature~     suggests that mindfulness-based interventions may lead to improvement in many disorders~     including chronic pain, stress, anxiety, eating disorders and depressive relapse. The purpose~     of this study is to collect survey pilot data to determine whether an 8-week program of~     mindfulness-based stress reduction (MBSR) improves symptoms and quality of life for persons~     with IBS. Patients in the 8-week MBSR program are referred as part of their clinical care,~     and we seek approval only to collect survey data before and after the MBSR course. This study~     will evaluate whether there is sufficient evidence of efficacy to warrant a full clinical~     trial of MBSR.~   "
204852|NCT00880243|"~     The purpose of this study is:~        1. To compare priming with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) during~          induction and consolidation courses versus no priming.~        2. To compare as consolidation timed sequential chemotherapy versus four courses of high~          dose cytarabine.~   "
204853|NCT00880230|"~     The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in~     subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo~     or restenotic lesions in the common and/or external iliac artery.~   "
204854|NCT00880217|"~     The purpose of this study is to evaluate the efficacy and safety/tolerability of 3 different~     dosages of JNJ-31001074 compared with placebo in adult patients with~     attention-deficit/hyperactivity disorder (ADHD).~   "
204855|NCT00880204|"~     The aim of the proposed study is to determine if specific training in management of general,~     obstetric, neonatal and pediatric emergencies results in a change in practice of doctors~     working in emergency departments of public sector hospitals in three districts of Pakistan.~     The overall goal of the proposed study is to test the ability of a standard course (5-days~     training) to promote the provision of effective and evidence based practices in public sector~     hospital settings.~   "
204856|NCT00880191|"~     RATIONALE: Gabapentin may prevent or reduce delayed nausea and vomiting caused by~     chemotherapy. It is not yet known whether gabapentin is more effective than a placebo in~     preventing nausea and vomiting.~      PURPOSE: This randomized phase III trial is studying the side effects of gabapentin and to~     see how well it works compared with a placebo in preventing nausea and vomiting in patients~     receiving chemotherapy.~   "
204857|NCT00880178|"~     Coronary heart disease (CHD) is a serious health concern that affects millions of people in~     the United States. It is usually caused by atherosclerosis—a condition that occurs when fatty~     material and plaque build up on the walls of the arteries that supply blood and oxygen to the~     heart, causing the arteries to narrow. As the arteries narrow, blood flow to the heart can~     slow down or stop, which can cause chest pain, shortness of breath, heart attack, or heart~     failure. Another component of CHD events involves inflammatory changes that result in~     structural breakdown of atherosclerotic plaques. Adding niacin to statin medications may be~     an effective way to block inflammation in the atherosclerotic plaques. This study will~     examine magnetic resonance imaging (MRI) images and blood samples of participants in the~     AIM-HIGH study who are taking niacin plus statins or statins alone to determine the effect of~     these medications on inflammation in atherosclerotic plaques.~   "
204858|NCT00880165|"~     This research study is comparing home and in-laboratory testing of veterans with suspected~     obstructive sleep apnea, a common breathing disorder during sleep. It is hoped that home~     testing will be equally effective in improving quality of life but have lower cost than~     in-lab testing. These findings will allow veterans to have greater access to diagnosis and~     treatment of their sleep apnea.~   "
204877|NCT00879918|"~     The investigators hypothesize that African Americans (AAs) smoke more for positive~     reinforcement from nicotine with a peak-seeking pattern of smoking (smoking individual~     cigarettes more intensively with greater intake of nicotine and tobacco smoke toxins), while~     whites smoke more for negative reinforcement with a trough-maintaining pattern (avoiding~     withdrawal by maintaining more consistent nicotine levels throughout the day by means of a~     more regular smoking pattern). The investigators believe that these patterns are linked to~     identifiable racial differences in nicotine pharmacology and that there will be associated~     racial differences in responses to pharmacologic interventions.~   "
204878|NCT00879905|"~     This study will study the safety, tolerability and metabolism of a drug called HSP990 when~     given by mouth once a week or twice weekly to subjects with advanced solid tumors.~   "
204859|NCT00880152|"~     PTSD is a common consequence of war, for soldiers and civilians. PTSD results in~     hyperarousal, avoidance, numbing, and re-experiencing, causing persistent decreased quality~     of life. Mindfulness involves the ability to bring attention to the present moment without~     judgment; this ability is correlated with measures of mental health. Within health care,~     mindfulness is taught as an 8-week course called Mindfulness-Based Stress Reduction (MBSR).~     MBSR is unstudied for PTSD. We propose to assess the feasibility of MBSR as an intervention~     for PTSD, since it may affect hypervigilance, avoidance, and reactivity associated with this~     disorder.~      Specific Aims: Aim 1: Assess the feasibility of recruiting and retaining a sample of veterans~     with PTSD to complete a study protocol that involves randomization to usual care or usual~     care plus MBSR. Aim 2: Apply measures of PTSD symptom severity, depression and quality of~     life before and after randomization, to assess whether there is evidence of benefit and~     whether MBSR warrants further study for PTSD, and allow calculation of standardized effect~     sizes. Aim 3: Apply a validated measure of mindfulness before and after treatment. Aim 4:~     Explore the relationship between PTSD symptoms, mindfulness score, and frequency of~     meditation practice.~   "
204860|NCT00880139|"~     There is much evidence that localized low grade inflammatory processes may contribute to the~     microvascular complications of type 1 and type 2 diabetes mellitus including~     sight-threatening diabetic retinopathy. Some biomarkers for inflammation have been found to~     be elevated in diabetes patients and correlations between those biomarkers and the severity~     of diabetic complications have been found in the last years. The relation between this low~     grade inflammation and the microvascular changes observed in diabetic retinopathy is,~     however, not well characterized.~      In the present study patients with different stages of non-proliferative diabetic retinopathy~     will be included. Several markers of inflammation will be measured from blood samples. These~     markers will be related to vascular factors including flicker-induced vasodilatation as a~     marker of endothelial dysfunction and perifoveal leukocyte velocity and density as measured~     with the blue field entoptic phenomenon. In addition, the ophthalmologic status of the~     patients will be assessed according to the Modified Airlie House classification.~      A multiple regression model will be employed to study the association between the different~     methods.~   "
204861|NCT00880126|"~     The effects of using Community Development Teams to increase the number of counties that~     successfully implement and sustain Multidimensional Treatment Foster Care programs is studied~     in a randomized trial in 40 California counties. MTFC is an alternative to group or~     residential placement for youth with severe conduct and emotional problems referred from the~     juvenile justice and child welfare systems.~   "
204862|NCT00880113|"~     Less than 10% of all ischemic stroke patients are treated by intravenous thrombolysis (IVT)~     as most present later than the accepted 3 hour time window. Intra-arterial thrombolysis (IAT)~     is possible 3-6 hours post ictus, but is infrequently used. Mechanical thrombectomy (MT) with~     a MERCI device is a new intervention possibility but lacks large randomized studies. Although~     it is desirable to treat more stroke patients, clinical information and plain CT alone are~     insufficient to discriminate which patients are most likely to benefit or be harmed from~     treatment. Advanced imaging techniques can help predict patient outcome and provide the~     necessary information to weigh expected benefit against associated risk of treatment.~     Visualizing the penumbra, the hypoperfused tissue at risk of infarction around the~     irreversible infarct core, is one way of identifying patients most likely to benefit from~     intervention. Magnetic resonance imaging (MRI) based selection of patients with sufficient~     penumbra for thrombolysis is possible, however, MR has less 24-hour availability than CT in~     the acute setting. Plain CT is mostly used to exclude intracerebral hemorrhage, and can~     easily be extended with CT perfusion (CTP) and CT angiography (CTA). CTP compares well to MRI~     for imaging penumbra and infarct core, and it is faster and more feasible than MRI. Other~     image findings such as infarct core size and leakage of the blood-brain-barrier~     (permeability) on CTP, and site and extent of the occlusion and collateral circulation on CTA~     also influence stroke outcome but have not been combined in one study to assess their~     combined predictive value.~      Hypothesis:~      The investigators hypothesize that combined CTP and CTA parameters can predict patient~     outcome in acute ischemic stroke.~   "
204863|NCT00880100|"~     Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of~     Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption~     in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma~     (formerly Axcan).~   "
204864|NCT00880087|"~     Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in~     which the body's temperature is lowered and maintained several degrees below normal for a~     period of time, has been used to successfully treat adults who have experienced cardiac~     arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing~     survival rates and reducing the risk of brain injury in infants and children who experience a~     cardiac arrest while in the hospital.~   "
204865|NCT00880074|"~     The goal of this clinical research study is to learn if an imaging solution,~     [F-18]-fluoro-L-thymidine (FLT), when used with a positron emission tomography (PET) scan,~     can help doctors to better see changes in the growth of tumors in the body. Researchers want~     to learn if FLT-PET scans can show an early response to chemotherapy.~   "
204879|NCT00879892|"~     The main purpose of this study is to explore whether xenon is neuroprotective in humans. In~     addition, the purpose is to explore the underlying mechanisms for the possible synergistic~     neuroprotective interaction of xenon and hypothermia in patients suffering cerebral ischemia~     post cardiac arrest, by undertaking brain imaging to evaluate their effects on cerebral~     hypoxia, neuronal loss and mitochondrial dysfunction. In addition, the investigators aim to~     correlate these findings with neurological outcome to determine surrogate markers of~     favourable clinical outcome at six months.~   "
204880|NCT00879879|"~     RATIONALE: Losartan may be effective in treating patients with idiopathic pulmonary fibrosis.~      PURPOSE: This clinical trial is studying the side effects of losartan and to see how well it~     works in treating patients with idiopathic pulmonary fibrosis.~   "
205121|NCT00876681|"~     Research study to determine if pain relief following foot and/or ankle surgery is influenced~     by the technique used to place perineural catheter. The catheters are placed using~     ultrasound-guidance or nerve stimulation and the method is selected at random using a~     computer program. This may help to determine if one of these methods is associated with an~     increased success rate and incidence of foot numbness during the infusion.~   "
204866|NCT00880061|"~     Background:~        -  Diffusely infiltrating pontine glioma (DIPG) or supratentorial high-grade glioma (HGG)~          are brain tumors that are often difficult to treat. It is very difficult to get~          chemotherapy agents to tumors in the brain, and researchers are looking for new methods~          to directly treat these types of cancer.~        -  IL-13 is an immune molecule normally occurring in the body. Patients with gliomas appear~          to have significant amounts of the IL-13 receptors in their brain tumors. An~          experimental drug, IL13-PE38QQR, combines a bacteria toxin with human IL-13 to allow the~          toxin to enter and destroy the tumor cell. Early clinical studies suggest this treatment~          may prolong survival of patients with these types of brain tumors.~        -  A technique called convection-enhanced delivery (CED) uses continuous pressure to push~          large molecules through the membranes protecting the brain to reach brain tumors. This~          technique can treat a tumor more directly than with traditional methods.~      Objectives:~        -  To test the safety and feasibility of giving IL13-PE38QQR directly into regions of the~          brain in pediatric patients with DIPG or HGG, using CED.~        -  To determine the most appropriate dose of IL13-PE38QQR to treat DIPG or HGG.~        -  To determine the effects of this experimental therapy on the tumor.~        -  To evaluate the physical changes in the tumor before and after the therapy.~      Eligibility:~        -  Patients who are less than 18 years of age and have been diagnosed with either DIPG or~          with supratentorial HGG that has not responded well to standard treatments.~      Design:~        -  Patients will be admitted to the hospital and will receive a magnetic resonance imaging~          (MRI) scan to show the exact location of the tumor. A small plastic tube will be~          inserted surgically into the tumor area, and IL13-PE38QQR and a MRI contrast agent~          (gadolinium DTPA) will be infused into the area.~        -  MRI scans will monitor the process, and the tube will be removed after surgery.~        -  Doses will be adjusted over the course of the study.~        -  Patients who respond well to treatment may be eligible to receive a second infusion, no~          sooner than 4 weeks after the first treatment.~        -  Post-treatment visits:~      Clinic visits 4 and 8 weeks after the treatment, and then every 8 weeks for up to 1 year.~        -  Physical examination with neurological testing, an MRI, and standard blood and urine~          tests.~   "
204867|NCT00880048|"~     This is a 6-week, randomised, multicenter, double-blind, placebo controlled, fixed dose~     parallel group study to assess the efficacy and safety of orvepitant (30 and 60 mg/day)~     versus placebo in subjects with a diagnosis of a Major Depressive Disorder, whose symptoms~     are considered moderate or severe.~      Following an initial screening visit, subjects fulfilling the study inclusion and exclusion~     criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory~     and ECG assessments and to confirm eligibility for inclusion into the study. This screening~     phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the~     screening period, eligible subjects will be randomised at the baseline visit to receive~     either orvepitant 30mg/day, orvepitant 60mg/day or placebo (equal chance of receiving any of~     the three possible treatments, i.e., a 1:1:1 ratio) for a six-week double-blind treatment~     phase. Those subjects randomised to receive placebo will receive study medication identical~     in appearance to that received by subjects assigned to receive orvepitant 30 or 60mg/day.~      Efficacy will be assessed via standard depression symptom and severity rating scales or~     questionaires. The Hamilton Depression Rating Scale (HAM-D) will be used as the primary~     measure. Secondary efficacy endpoints include the Quick Inventory of Depressive~     Symptomatology (QIDS-SR) and the Clinical Global Impression- Global Improvement and Severity~     of Illness Scale (CGI-I and CGI-S, respectively).~      Safety will be assessed by monitoring for adverse events (side effects) and through periodic~     laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart~     rate, temperature) and heart function measurements (electrocardiograms, or ECGs).~   "
204868|NCT00880035|"~     Major objective: a three-days interventional cross-over trial [one day music on, one day~     wash-out, one day music off][two periods of listening/day], to evaluate:~        1. Impact on sedative drug consumption.~        2. Alteration of stress neuropeptide blood concentrations.~      Population: mechanically-ventilated ICU patients~      The investigators hypothesize the music will decrease the need of sedative drugs and reduce~     the concentration of neuropeptides in circulation.~   "
204869|NCT00880022|"~     No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on~     reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit~     of applying truncal/chest pneumatic compression therapy to open lymph channels in individuals~     who have only limb lymphedema or its impact on the trunk/chest. The purpose of this two-part~     study is to fill gaps related to: 1) the impact of the Flexitouch® System on truncal~     lymphedema, and 2) the therapeutic benefit of truncal /chest pneumatic compression therapy~     for arm lymphedema.~      Hypotheses:~      Part One: BCS with arm and truncal lymphedema. H1: Arm swelling (as measured by bioelectrical~     impedance & arm girth in cm) will be reduced after 10 sessions with the Flexitouch® System.~      H2: Truncal swelling (as measured circumferentially) will be reduced after 10 sessions with~     the Flexitouch® System.~      H3: The number, severity, and intensity, of physical and psychological symptoms (as measured~     by the Lymphedema Symptom Intensity and Distress Scale: Trunk and Arm) will be reduced after~     10 sessions with the Flexitouch® System.~      H4: Functional assessment scores (as measured by the Functional Assessment Screening~     Questionnaire [FASQ] will improve after 10 sessions with the Flexitouch® System.~      Part Two: BCS with Arm Lymphedema H1: Arm volume (as measured by bioelectrical impedance &~     arm girth in cm) will be significantly reduced after one month of home use in participants~     using the Flexitouch® System (truncal, chest, and arm compression) when compared to those~     using the Flexitouch® System (arm compression only).~      H2: Truncal measurements/volume (as measured circumferentially) will be less after one month~     of home use with the Flexitouch® System (truncal, chest, and arm compression) when compared~     to those using the Flexitouch® System (arm compression only).~      H3: The number, severity, and intensity, of physical and psychological symptoms (as measured~     by Lymphedema Symptom Intensity and Distress Scale - Arm ) will be significantly reduced~     after one month of home use with the Flexitouch® System (truncal, chest, and arm garments)~     when compared to individuals using the Flexitouch® System (arm compression only) .~      H4: Functional assessment scores (as measured by the FASQ) will be significantly higher after~     one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when~     compared to individuals using the Flexitouch® System (arm compression only).~   "
204870|NCT00880009|"~     This is a phase 2 study of bosutinib administered in combination with letrozole versus~     letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects~     in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28~     days. The second part will proceed with subjects receiving a dose that is determined to be~     safe based on the safety evaluation of the first part. Eligible subjects will be randomly~     assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole~     alone for a specified period of time. Subjects will be followed up for survival after study~     drug discontinuation.~   "
204871|NCT00879996|"~     The purpose of this study is to determine if buprenorphine or methadone is better for the~     treatment of chronic pain among patients who have become addicted to prescription narcotics.~   "
204872|NCT00879983|"~     The purpose of this study is to estimate the pharmacokinetics and evaluate the safety~     following a single dose of azithromycin 2g extended-release powder for oral suspension with a~     3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This~     study data will be used to support azithromycin NDA in China.~   "
204873|NCT00879970|"~     This study will answer two separate questions.~      The first question is to test the cardiovascular effects of long-term treatment with~     rosiglitazone or pioglitazone when used as part of standard of care compared to similar~     standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who~     have a history of or are at risk for cardiovascular disease.~      The second question will compare the effects of long-term supplementation of vitamin D on~     death and cancer~   "
204874|NCT00879957|"~     Background: Heparin is an anticoagulant commonly used in the neonatal population as a means~     to prevent catheter related occlusion and malfunction by thrombosis (clot). Given the recent~     overdoses of infants using heparin, there is concern as to whether heparin should be used in~     peripherally inserted central venous catheters (PICC). Scientific evidence comparing the~     duration of use of heparin versus no heparin in PICCs is conflicting.~      Purpose: The purpose of this study is to evaluate the effect of continuous IV fluids with~     heparin versus IV fluids without heparin on the duration of percutaneously inserted central~     venous catheters (PICC) in neonates.~      Design: Prospective, double-blind, randomized controlled trial Hypothesis: The use of heparin~     in PICC fluids has no difference on duration of catheter patency.~      Design and Methods: The study will be conducted at the Neonatal Intensive Care Unit at~     University Hospital, San Antonio, TX. Randomization to either the experimental group~     (no-heparin) or the standard medical group (with heparin) will occur once parental consent is~     obtained and prior to PICC insertion. PICC placement will be done by the PICC certified~     neonatal nurses. Correct placement of the PICC will be assured by radiography which is~     standard procedure.~      Parents, NICU team members and staff, and investigators will be masked to the grouping.~     Pharmacy will be responsible for randomization. Both the heparin group and the no heparin~     group solutions will be dispensed in identical containers, compounded by the pharmacy.~      The study medication, heparin, will be mixed by the pharmacy at a standard dose of 0.5~     units/mL for the intravenous infusions used in the heparin group. The experimental group will~     receive only the base solution, whether it is 5% dextrose, 0.9% sodium chloride, or total~     parenteral nutrition infused into the PICC line. Pharmacy and the NICU staff will ensure~     compatibility of heparin with other infusions. Heparin bonded catheters, heparin flushes, and~     hep-lock solutions are not used by the NICU service.~      The primary outcome, duration of catheter use, is defined as the time (in hours) between~     insertion and removal of the catheter due to occlusion. Occlusion will be defined as the~     inability to push 1 mL of 0.9% sodium chloride, via a 5 mL syringe, through the catheter in~     situ or detection of clots along the catheter after removal.~      Secondary outcomes include septicemia vs. catheter-related septicemia, phlebitis, death~     before discharge, and thrombosis. Septicemia is identified as clinical signs and symptoms~     associated with sepsis in the presence of a positive peripheral blood culture obtained~     irrespective of the catheter tip culture result. Catheter-related sepsis will be defined as~     positive blood culture obtained from the catheter fluid as well as a positive blood culture~     obtained from a peripheral venous specimen. Both cultures must demonstrate the same organism.~     Phlebitis is defined by visual detection, swelling, and change of skin color associated with~     an inflamed vein. Thrombosis is defined as a thrombus along catheter path diagnosed by visual~     inspection upon removal of the catheter. Elective versus non-elective removal will also be~     recorded.~      Adverse events monitored include: heparin induced thrombocytopenia (HIT), defined as a~     platelet count dropping below 50 x 103/mL with a positive antibody titer, aPTT > 100 seconds~     (This will be measured upon clinical evidence of bleeding), hemorrhage from > 2 sites,~     intraventricular hemorrhage, extravasation, and dislodgement or breakage of catheter.~      The sample size will be determined based on retrospective data collection to reach a~     statistical power of 80% with a type I error or 0.05. The investigators expect the sample~     size to be approximately 102 patients in each arm of the study.~      The study will terminate once the PICC is discontinued or if there is an indication to stop~     the study early for safety reasons. These could include increased adverse events in one group~     versus the other. A Safety Control Panel composed of 2 neonatologists from another site will~     review the data at the points when 1/3 and then 2/3 of total patient enrollment has been~     achieved.~      Data Collection and Analysis: Data will be collected and tabulated on a Microsoft Excel~     spreadsheet using unique patient identifiers and stored at a secure location at UHS then~     analyzed using appropriate statistical tests.~   "
204875|NCT00879944|"~     The object of this research study is to examine these associations in children as very little~     is known about psoriasis and cardiovascular risk factors in the pediatric population.~   "
204876|NCT00879931|"~     Hypothesis: Corticoid treatment in cardiac surgery works renal protective.~      Study design: Randomized, double blind trial in which one group of patients will receive~     methylprednisolone and the other group (control) will receive placebo NaCl 0.9%.~   "
204881|NCT00879866|"~     Primary trial objective in this single arm trial is to assess the safety and tolerability of~     Selectikine (EMD 521873) given in combination with and local tumor irradiation and to~     determine whether the maximum tolerated dose (MTD) is reached with EMD 521873 doses of up to~     0.45 mg/kg.~      Secondary objectives are to evaluate PK, immunogenicity, overall response, changes in tumor~     marker levels and circulating tumor cell numbers, progression-free survival and overall~     survival. Also, to evaluate biological/immune responses to EMD 521873.~      NSCLC patients have to be stable (PR or SD) after first-line chemotherapy in order to be~     enrolled. A total of 12 to 24 patients are planned. Patients will remain on the dose~     throughout the trial. It is intended to administer at least 4 cycles (21 d each), or until~     progression or 2nd line therapy becomes necessary.~   "
204882|NCT00879853|"~     The enormous global burden of mental illness has been estimated through the publication of~     the Global Burden of Disease Study, adding momentum to refugee mental health studies (1,2).~     As research confirms that high levels of Posttraumatic Stress Disorder (PTSD) and depression~     occur in post-conflict settings, it is essential to develop effective treatment for~     psychological trauma in refugee populations recovering from mass violence (3-4). PTSD and~     depression are risk factors for anger, interpersonal discord and violence, not only among~     those who have trauma and depression, but also among their spouses and children (5-9). This~     infectious model of trauma/violence is critically important in the setting of ethnic~     conflict, as increased levels of interpersonal violence within the afflicted community hinder~     its recovery and fuel future cycles of conflict. To date, there has been little research on~     the interpersonal effects of trauma among refugee populations. The proposed research is a~     pilot and randomized controlled trial of Interpersonal Therapy (IPT) for Sudanese refugees~     living in Cairo. IPT, a very effective therapy for depression, has been adapted for PTSD~     treatment and sub-Saharan Africa settings (10-12). Measures will evaluate success of the~     treatment not only in terms of individual PTSD and depression symptoms, but also with respect~     to interpersonal conflict. Hypotheses: (1) After IPT intervention, Sudanese refugees will~     have lower levels of depression and trauma symptoms compared to wait list controls (2) After~     IPT intervention, Sudanese refugees will have lower levels of interpersonal violence compared~     to wait list controls.~   "
204883|NCT00879840|"~     Background:~        -  Endometrial and ovarian cancers are, respectively, the fourth and eighth most common~          cancers among women in the United States. Although some routine Pap tests may detect the~          presence of cancer cells, there are no convincing early detection approaches for either~          cancer. Better methods of detection are needed.~        -  Two possible methods for cancer detection involve samples taken with a tampon or a~          special kind of brush, called a Tao brush. Researchers would like to know more about how~          well these methods work.~      Objectives:~        -  To assess the quality of DNA collected by the tampon and Tao brush sampling methods.~        -  To detect genetic markers in collected DNA and determine if these markers are related to~          an individual s cancer status.~      Eligibility:~        -  Women age 45 years and older with confirmed or suspected endometrial or ovarian cancer,~          who will be having surgery.~        -  A control group of postmenopausal women having surgery for benign gynecological~          conditions will be included.~      Design:~        -  Shortly before hysterectomy or more extensive procedures to treat either cancer or the~          benign condition:~        -  A tampon will be inserted into the vagina to collect cell samples, and removed after 30~          minutes.~        -  After the tampon is removed, the cervix will be swabbed with the Tao brush to collect~          cell samples.~        -  Following the hysterectomy, samples of healthy and cancerous tissue will be taken, and~          tested by researchers.~   "
204884|NCT00879827|"~     The purpose of this study is to evaluate the immune response and reactogenicity of GSK~     Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine,~     administered concomitantly as a three-dose primary vaccination course.~   "
204885|NCT00879814|"~     The purpose of this study is to evaluate the safety and tolerability of an investigational~     meningococcal B rLP2086 vaccine in healthy adults.~   "
204886|NCT00879801|"~     There are few longitudinal studies in the Caucasian population and even less in the Italian~     population in subjects with impaired glucose regulation to allow:~        1. An estimate of the rate of conversion to type 2 diabetes;~        2. To identify subjects at risk; and~        3. To assess the physiopathologic mechanisms responsible for the conversion.~      In order to set up a longitudinal study capable of defining the above parameters it is~     mandatory that the physiological, biochemical, and, genetic markers specific for IGR are~     identified. The goals of the present research proposal are:~        1. To clarify the physiological mechanisms responsible for IGR;~        2. To identify the biochemical and beta-cell auto-immune parameters present in IGR;~        3. Identify genetic markers.~      The subjects who will be identified will add up to other 900 individuals who will be~     recruited as part of a follow-up program sponsored by the Italian Society of Diabetes,~     specifically designed to assess conversion rate to diabetes.~   "
204887|NCT00879788|"~     The study was conducted as an open label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules~     of Ohm Laboratories Inc., with Altace® capsule 10 mg (containing ramipril 10 mg) manufactured~     by King Pharmaceuticals Inc, Bristol and Distributed by Monarch Pharmaceuticals Inc, Bristol~     in healthy, adult, male, human subjects under fed condition.~   "
204888|NCT00879775|"~     Pain is a most common symptom and it has a high impact on quality of life in cancer patients.~     Many cancer patients have received opioid therapy, but also many of them have suffered from~     side effects of opioids. Drowsiness and confusion are common side effects of opioids.~     Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the~     investigators aimed to prove the efficacy of intravenous caffeine administration as an~     adjuvant analgesics to opioids. At the same time, the investigators tried to find that the~     side effects of opioids could be ameliorated by caffeine.~   "
204920|NCT00879346|"~     Phase I, randomised, open label, 3-period crossover study in healthy male subjects to~     investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the~     safety and tolerability of AZD8931.~   "
204921|NCT00879333|"~     This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients~     with advanced gastric cancer which has progressed after one or two lines of prior~     chemotherapy.~   "
204889|NCT00879762|"~     The purpose of this research is to compare the ability of a new investigational smallpox~     vaccine called IMVAMUNE® to produce a strong immune response against smallpox disease if~     given as one single, higher dose compared with two lower doses given one month apart. Another~     purpose of the study is to see how quickly someone might be protected against smallpox.~     Volunteers will be vaccinia-naïve adults age 18 and older (born after 1971) divided into 2~     groups. Volunteers in Group A will receive a high dose of vaccine given in 2 shots on day 0~     followed by a placebo (inactive substance) shot on day 28. Group B will receive the standard~     dose of vaccine and placebo given in 2 shots on day 0 followed by a standard dose shot on Day~     28. Study participation will include 10 planned study visits over approximately 7 months.~   "
204890|NCT00879749|"~     The main purpose of this study is to determine the safety of weekly injections of Nexvax2~     given for three weeks to patients with coeliac disease who have been on a gluten-free diet.~      The second purpose of this study is to compare the immune response over the three week study~     period in coeliac disease patients given Nexvax2 compared to those given saline.~   "
204891|NCT00879736|"~     This study is being carried out to see if patients make the lifestyle changes or take their~     medication as instructed by their doctor during their visit as a result of the T.H.T.~     patient-education training. Proper information exchange between doctors and patients is an~     important part of quality health care. Although many patients would like more information,~     they often do not ask for it directly during doctor-patient visits. The patient-training in~     this study specifically aims at improving patient participation during medical appointments~     by building communication skills such as requests for information and sharing health concerns~     with the doctor.~   "
204892|NCT00879723|"~     Burn injury patients undergo a series of metabolic changes that, if untreated, could lead to~     reduced health outcomes. Nutrition is thought to play a vital role in post-burn recovery. The~     research team developed a novel vitamin and mineral supplementation protocol based on current~     scientific literature. The study will test the hypothesis that the novel vitamin and mineral~     supplement regimen will improve adult patient recovery from burn injury.~   "
204893|NCT00879710|"~     HMG CoA reductase inhibitors (statins) are commonly used to treat high cholesterol (HC) in~     both type 1 and type 2 diabetes mellitus (DM). Several studies have shown benefits of statin~     among patients of type 2 DM, however, no such data is available for patients with type 1 DM.~      It is known from studies on cholesterol metabolism using surrogate markers that patients with~     type 1 DM have higher cholesterol absorption compared to normals and those with type 2 DM~     have higher cholesterol synthesis. Since statins inhibit synthesis, patients with type 1 DM~     may not have a good response and may respond better to cholesterol absorption inhibitors. The~     purpose of this study is to determine the cholesterol lowering effects of cholesterol~     absorption inhibitors and cholesterol synthesis inhibitors in subjects with type 1 and type 2~     diabetes mellitus.~   "
204894|NCT00879697|"~     Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in~     patients with intermittent claudication (IC), suggesting that strength training (ST) could~     improve exercise performance in these patients.~      Objective: Analyze the effects of ST in walking capacity in patients with IC comparing with~     walking training (WT) effects.~      Intervention: Patients were randomized into ST and WT. Both groups trained twice a week, for~     12 weeks, at the same rate of perceived exertion. ST consisted of 3 sets of 10 repetitions of~     whole body exercises. WT consisted of 15 two-minute bouts of walking intercalated with 2~     minutes of resting.~      Measurements: Walking capacity, peak VO2, walking economy, ankle brachial index, ischemic~     window and knee extension strength~   "
204895|NCT00879684|"~     The purpose of this study is to determine the safety and tolerability of CVX-060 in patients~     with advanced solid tumors.~   "
204896|NCT00879671|"~     The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein~     and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea.~     Since light entering the eye passes through the MP before reaching the photo receptors it~     absorbs a significant portion of short-wavelength light. There is evidence that this~     absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen~     species are protective for the retina.~      Age-related macular degeneration is the leading cause of blindness among developed countries.~     The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit~     and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD).~     Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD.~     The present study investigates whether 6 months lutein supplementation increases MP optical~     density (OD), influences visual acuity, depth and dimension of central scotoma and alters~     symptoms in patients with AMD.~   "
204897|NCT00879658|"~     The purpose of this study is to determine the dose-response curve for the MRI-based efficacy~     of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis~     (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose~     in a later phase III study.~      Study Design Rationale An adaptive design was chosen to characterize the dose response curve~     of BAF312. In a first period of study (Period 1), three doses of BAF312 and placebo are~     tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two~     additional active doses for period 2 have been selected , thus allowing to optimize the~     overall determination of the dose response curve with 5 data points of active treatment, and~     placebo. The doses are kept blinded. The use of Modeling and Simulation allows to establish~     the full range and dynamics of the dose-response curve in silico, and hence the definition of~     the optimal dose for later phase III studies.~      The choice of placebo as treatment control is essential to obtain information on the specific~     compared to non-specific effects of active treatment and provides the best way of evaluating~     the efficacy and of assessing the true safety and tolerability profile of BAF312. Short-term~     placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) is unlikely to lead to~     longer term differences in outcomes [Polman, 2008]. The use of an adaptive design strategy~     contributes to a significant reduction of placebo exposure, both in terms of the number of~     patients and duration, as compared to conventional trial models.~      Patients having completed the study within the protocol may be eligible for the Extension~     Phase study where they receive long-term BAF312 treatment (a separate protocol).~   "
206075|NCT00864058|"~     To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of~     NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under fasting~     conditions~   "
204898|NCT00879645|"~     This is a Phase 1 study to assess the pharmacokinetics (PK) of IK-1001 (sodium sulfide) in~     healthy volunteers as well as in subjects with varying degrees of impaired renal function. A~     total of 28 subjects will be enrolled into the study over a 6 month period. There will be 4~     cohorts. The first cohort will consist of subjects with mild renal impairment, the fourth~     cohort will be subjects with intermediate renal impairment and the third cohort will be~     subjects with severe renal impairment and the second cohort will consist of normal healthy~     subjects. All subjects will receive the study drug for 3 hours as a single intravenous (IV)~     infusion and will be followed over a 7 day period.~   "
204899|NCT00879632|"~     There is sound evidence that quetiapine is effective in the treatment of manic and depressive~     episodes associated with Bipolar Disorder (BD) (Yatham et al 2006). However, even with the~     development of effective new treatment options, not all patients respond to treatments~     available. Biological markers have been investigated as predictors of response to treatment~     and of remission of symptoms. This would explain in part the individual's differences in the~     response to treatment, taking into account the genetic variability plus environmental factors~     influencing specific biological markers. A potential biological marker of response to~     treatment in BD would be the levels of neurotrophins, as they are, in fact, altered during~     acute mood episodes (Cunha et al 2006). Among neurotrophins, the Brain-Derived Neurotrophic~     Factor (BDNF) has been repeatedly and consistently reported to be associated with BD~     physiopathology (Post 2007). Furthermore, medications that are known to be effective in BD,~     like lithium and divalproex, increase BDNF levels.~   "
204900|NCT00879619|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and~     prednisone together with sunitinib malate may kill more tumor cells.~      PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel~     and prednisone together with sunitinib malate and to see how well it works in treating~     patients with prostate cancer that progressed after hormone therapy.~   "
204901|NCT00879606|"~     This is a prospective, randomized (1:1), double-blind, multi-center, Phase II clinical study~     to test the safety and efficacy of a recombinant chimeric anti-tissue factor antibody~     (ALT-836) versus placebo in patients with sepsis and acute lung injury/acute respiratory~     distress syndrome (ALI/ARDS). This study was divided into two parts and the first part of the~     study has been completed. In the first part of the study, sixty patients were randomized at a~     1:1 ratio to receive one dose of the study drug or placebo. In the second part of the study,~     ninety patients will be randomized at a 1:1 ratio to receive a multi-dose treatment regimen~     of single doses every 72 hours up to a maximum of 4 doses of the study drug or placebo,~     provided there are no safety concerns.~   "
204902|NCT00879593|"~     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting motoneurons,~     with a prevalence around 5/100.000. Respiratory muscle involvement is a major feature in ALS~     and remains the main prognostic factor. Timing and rate of progression of this respiratory~     muscle involvement is also highly variable among individuals.~      Respiratory manifestations justify a careful follow up including clinical evaluation,~     pulmonary function tests and blood gases. Prognostic value of respiratory muscle assessment~     has been clearly demonstrated in ALS, although several cut off values have been published.~     The clinical benefit of non invasive ventilation (NIV) is well established in ALS, but the~     optimal criteria for its initiation remain debated .~      The 1999 consensus for NIV selected classical criteria to consider NIV in patients with~     respiratory symptoms suggesting hypoventilation: daytime hypercapnia (PaCO2 > 45 mmHg),~     nocturnal SaO2 < 89 % more than 5 consecutive minutes and for progressive neuromuscular~     disorders (NMD) (mainly ALS), a vital capacity (VC) < 50 % pred or a PImax < 60 cmH2O.~      Besides daytime clinical and PFT assessment, nocturnal evaluation is essential in ALS. The~     prevalence of sleep apnea ranges from 16 % to 76 %.~      Transcutaneous PCO2 (tcPCO2) is an attractive technique to evaluate non invasively nocturnal~     hypoventilation. The technique is well validated in different settings. Its use in~     neuromuscular disorders (NMD) is recent. In particular one study has demonstrated a high~     predictive value of tcPCO2 for the development of daytime hypoventilation within 1 year. To~     our knowledge, this technique has not been specifically assessed in ALS. There is a potential~     role for nocturnal PtcCO2 monitoring in the close follow up of ALS patients. Indeed, a close~     respiratory follow up of ALS patients is essential to determine the optimal timing of NIV,~     avoiding the occurence of unexpected acute respiratory failure.~   "
204903|NCT00879580|"~     The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the~     Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.~   "
204904|NCT00879554|"~     The purpose of the study is to determine safety and tolerability of CVX-045 in patients with~     advanced solid tumors.~   "
204905|NCT00879541|"~     The aim of this study are to~        -  assess the efficacy of Biostate® [Study Product (SP)] in subjects with Haemophilia A~        -  compare the pharmacokinetics of Biostate® [SP] with the previously marketed product~          Biostate® (here referred to as Biostate® [Reference Product (RP)]).~      This study is divided into 3 parts:~      Part 1: Cross-over pharmacokinetic (PK) component. PK subjects will be randomised to~     determine the order in which they receive the two study products. This part of the study is~     double-blinded.~      Part 2: Efficacy component. All subjects will receive Biostate® [SP] as required to manage~     their haemophilia condition for an estimated period of 6 months (or minimum of 50 exposure~     days) to assess efficacy and safety of the product. This part of the study is open-label.~      Part 3: Repeat pharmacokinetic assessment. Subjects who participated in Part 1 (PK component)~     will undergo a repeat PK assessment on Day 180 following administration of Biostate® [SP].~   "
204906|NCT00879528|"~     PET-based consolidation and donor-based therapy after rescue in patients with Hodgkin's~     lymphoma refractory at first line therapy, or relapse early or late, undergone a second line~     chemotherapy.~   "
204907|NCT00879515|"~     By testing physiological responses to anxiety in people with nervous system developmental~     disorders, this study will identify specific physiological characteristics associated with~     response to anxiety treatments.~   "
204908|NCT00879502|"~     This study will examine whether individuals with the fragile X genetic premutation are likely~     to have emotional, social, and memory deficits and how the brain may be involved in these~     deficits.~   "
204922|NCT00879320|"~     The purpose of this study is to understand the relationship between ADHD and the overall~     health of someone with ADHD. People who have ADHD have trouble paying attention,~     concentrating, organizing, and planning. They may have trouble in school, at work, and at~     home. The investigators are interested in finding out whether these difficulties have had any~     influence in the past, current, or future health problems of someone with ADHD. About 100~     people with ADHD and 100 people without ADHD will take part in this research study, all~     through Massachusetts General Hospital (MGH).~   "
204909|NCT00879489|"~     The study uses a molecule or particle that is found only on cancer cells and is unique to~     cancer cells, as it is not detected on normal tissue. The molecule is known as oncofetal~     antigen or OFA. Because OFA is unique to cancer, the investigators feel OFA could be used to~     educate the patients' own defenses to more effectively fight the cancer on his or her own,~     that he or she is harboring. Although investigators found OFA to be present in large~     concentrations on all cancers, it was found to be especially abundant in breast cancers.~     Therefore, the investigators feel that this molecule would be a good target for stimulating~     patient defenses especially against breast cancer cells. To accomplish this, certain defense~     cells (immune cells)will be washed out from the patients' blood using a machine to which the~     patient is connected through two small cannula placed into veins located in the patients'~     arms those cells will be manipulated in the laboratory with artificially engineered OFA.~     These reeducated cells will be injected into the skin of patients. There will be a series~     of three skin injections in 4 week intervals. It is hoped that this treatment will convert~     the patients' defenses to a point that effective anti-cancer responses will be induced.~     Effectiveness of the treatment will be monitored with blood tests and assessment of the size~     of the cancers.~   "
204910|NCT00879476|"~     The study was conducted as an open label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover bioavailability study comparing Ramipril capsules 10 mg~     of OHM Laboratories Inc., USA with ALTACE® (ramipril) capsule 10 mg manufactured by King~     Pharmaceuticals Inc., Bristol, TN 37620, USA in healthy, adult, male, human subjects under~     fasting condition.~   "
204911|NCT00879463|"~     In cardiac operations under cardiopulmonary bypass(CPB), monitoring of brain tissue oxygen~     saturation with infrared spectrophotoscopy leads to a reduction of the number of packed red~     cell(PRC) transfusions during the period of extracorporeal circulation.~   "
204912|NCT00879450|"~     Children with a torticollis are usually referred for physiotherapy where they are evaluated,~     and given exercises as well as education to treat the condition. This study is being done in~     order to compare 2 methods of sharing information with parents of children with torticollis.~   "
204913|NCT00879437|"~     Currently, there are few effective treatments for the following aggressive brain tumors:~     glioblastoma multiforme, anaplastic astrocytoma, gliomatosis cerebri, gliosarcoma, or~     brainstem glioma. Surgery and radiation can generally slow down these aggressive brain~     tumors, but in the majority of patients, these tumors will start growing again in 6-12~     months. Adding chemotherapy drugs to surgery and radiation does not clearly improve the cure~     rate of children with malignant gliomas.~      The investigators are conducting this study to see if the combination of valproic acid and~     bevacizumab (also known as AvastinTM) with surgery and radiation will shrink these brain~     tumors more effectively and improve the chance of cure.~   "
204914|NCT00879424|"~     The goal of this clinical trial is to investigate the therapeutic role of vitamin D~     supplementation in a subset of patients with atopic dermatitis (AD): children with disease~     onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D~     supplementation in patients with either wintertime onset or exacerbation of AD will improve~     Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve~     the Investigator's Global Assessment.~   "
204915|NCT00879411|"~     Practical experience report (PER) investigating the effect of Micardis® on the average 24h~     blood pressure of therapy-naive and therapy-experienced patients~   "
204916|NCT00879398|"~     The objective of this study is to determine the problems and questions of safety and efficacy~     of Toviaz® under the standard conditions of usage.~   "
204917|NCT00879385|"~     OBJECTIVES:~      Primary Objectives~      1.To evaluate the safety and feasibility of the sequential use of a DNA methyltransferase~     (DNMT) inhibitor (decitabine) with a targeted biological agent against EGFR (panitumumab) for~     KRAS wild type tumors in the second or third line treatment of advanced metastatic colorectal~     cancer.~      Secondary Objectives~        1. To examine re-expression or a reduction in promoter methylation in genes involved in~          tumor suppressor pathways known to be important in colorectal cancer (CRC) or involved~          in EGFR signaling pathway.~        2. Evaluate overall response (OR = CR +PR) according to RECIST criteria at 2, 4, and 6~          cycles. Progression free survival, measured as the first evidence of tumor growth from~          the start of treatment will also be assessed.~        3. Measure CEA levels at the beginning of each cycle to examine if they correlate with~          treatment response or disease progression.~   "
204918|NCT00879372|"~     One of the main challenges in the treatment of Bipolar Disorder (BD) is to achieve better~     functioning outcomes after syndromal recovery. Even treatment-responsive patients, who remain~     symptomatically well for extended periods of time, frequently demonstrate sub-threshold~     symptoms and continuing psychosocial morbidity and cognitive impairment. The cognitive~     impairment that persists during interepisode periods stands out as a major correlate of~     functional impairment, and may be a core aspect of the BD pathophysiology.~      In this context, tianeptine stands out as a therapeutic agent with unique properties, which~     match most of the conditions found in BD.~      This is an enriched maintenance study of the use of tianeptine as an adjunctive therapy in~     bipolar depression. All participants will receive tianeptine in an open label manner for a~     period of two months, following which they will be assigned randomly to the treatment with~     tianeptine or placebo in a double-blind fashion for six months. All patients will remain on~     treatment as usual for the duration of the trial. Along with clinical response, the~     investigators will prospectively evaluate the improvement in working and declarative memory,~     two cognitive prefrontal- and hippocampus-dependent processes, respectively, and the effects~     of tianeptine on serum BDNF levels.~   "
204919|NCT00879359|"~     The purpose of this study is to find out whether the addition of a drug called Avastin~     (avastin) to the two-drug combination of carboplatin and paclitaxel shrinks tumors better~     than the two-drug combination alone in the treatment of endometrial cancer. Avastin is a~     humanized monoclonal antibody (a type of protein that is normally made by the immune system~     to help defend the body from infection and cancer) produced by Genentech, Inc. Avastin is an~     antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a potent,~     specific growth factor with a well defined role in normal and abnormal blood vessel~     formation. It is present in a wide variety of normal tissues, but is produced in excess by~     most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood~     vessels that feed the tumor cells.~   "
204923|NCT00879307|"~     There is sound evidence that quetiapine is effective in the treatment of manic and depressive~     episodes associated with Bipolar Disorder (BD) (Yatham et al 2006). However, even with the~     development of effective new treatment options, not all patients respond to treatments~     available. Biological markers have been investigated as predictors of response to treatment~     and of remission of symptoms. This would explain in part the individual's differences in the~     response to treatment, taking into account the genetic variability plus environmental factors~     influencing specific biological markers. A potential biological marker of response to~     treatment in BD would be the levels of neurotrophins, as they are, in fact, altered during~     acute mood episodes (Cunha et al 2006). Among neurotrophins, the Brain-Derived Neurotrophic~     Factor (BDNF) has been repeatedly and consistently reported to be associated with BD~     physiopathology (Post 2007). Furthermore, medications that are known to be effective in BD,~     like lithium and divalproex, increase BDNF levels.~   "
204924|NCT00879294|"~     The purpose of this study is to see if chewing gum after surgery for perforated appendicitis~     will shorten the time of intestinal dysfunction.~   "
204925|NCT00879281|"~     The purpose of this randomized controlled trial is to evaluate the hypothesis that the~     'written' action plan, a self-management tool developed by the project group, enhances early~     detection and prompt action measures and consequently isbeneficial in exacerbation outcome~     (i.e., health status recovery time).~   "
204926|NCT00879268|"~     This is a pilot trial of centrifugal machine preservation of donor livers for transplantation~     using a novel preservation solution.~   "
204927|NCT00879255|"~     The immediate objective of this project was to evaluate the clinical effectiveness of a~     telemental health modality (video-teleconferencing) for providing an evidence-based group~     intervention (Cognitive Processing Therapy; CPT) to rural OIF/OEF Reservists, National~     Guardsmen, and veterans suffering with PTSD.~   "
204928|NCT00879242|"~     This study will assess the safety and efficacy of deferasirox in patients with cardiac MRI~     T2* < 20 msec.~   "
204929|NCT00879229|"~     Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary~     hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis~     of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are~     also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of~     ambrisentan in that patient population.~   "
204930|NCT00879216|"~     The main purpose of this study is to investigate whether the hypotensive effects of an~     alpha-blocker are increased when VA106483 is given at the same time.~   "
204931|NCT00879203|"~     LO5 study: The investigators are inviting a new group of youth (ages 7-16) who have been~     recently diagnosed with type 1 diabetes and their non-diabetic siblings. These youth will~     complete cognitive tests and a MRI scan of the brain. This scan uses strong magnets to obtain~     pictures and does not involve any radiation or injections. The investigators will recruit~     patients within three months of their diagnosis date. The study entails 1 study visit that~     lasts 3.5 hours. Evening and weekend times are available. The investigators plan to enroll~     135 participants.~      HY5 study: The investigators are inviting a cohort of youth and young adults (ages 9-21) with~     type 1 diabetes and their non-diabetic siblings for a follow-up to a study they have already~     completed. This group of people will complete several memory and thinking tests along with~     several MRI scans of their brain, just as they did at their previous visits. The~     investigators plan to enroll 150 participants.~   "
204932|NCT00879190|"~     Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters)~     surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat~     common and is routinely treated with antibiotics given to the mother both before and after~     the baby is born. Currently it is not known what is the best choice of antibiotics to treat~     this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or~     ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if~     one is better than the other at treating and preventing bad outcomes from chorioamnionitis in~     women and babies.~   "
204933|NCT00879177|"~     In total, 260 patients with pre- and stage I hypertension, who are regular smokers, will be~     randomized to: varenicline alone or varenicline plus behavioral therapy. Patients in both~     conditions will receive varenicline (titrated to a maximal dose of 1.0 mg twice daily) for 12~     weeks along with standard smoking cessation therapy and regular carbon monoxide (CO) and~     cotinine monitoring. A significantly higher proportion of behavioral therapy patients are~     expected to achieve and maintain long durations of abstinence than patients receiving~     varenicline alone. Clinic and 24-hour blood pressure (BP) and heart rate (HR) will be primary~     clinical outcomes. The investigators expect that BP and HR will decrease more among~     behavioral therapy than non-behavioral therapy patients and reductions in smoking may mediate~     decreases in these indices.~   "
204934|NCT00879164|"~     RATIONALE: A stellate ganglion nerve block may help relieve hot flashes in women.~      PURPOSE: This clinical trial is studying how well a stellate ganglion nerve block works in~     treating women with hot flashes.~   "
204935|NCT00879151|"~     In the face of scant literature on the subject, the investigators aim to more clearly~     identify effective treatments for adolescent bulimia nervosa (BN) through a treatment study~     comparing two current treatments (Cognitive Behavioral Therapy for Adolescents, CBT-A and~     Family Based Therapy for Bulimia Nervosa, FBT-BN) for the disorder in comparison with a~     non-specific therapy, Supportive Psychotherapy for Adolescent Bulimia (SPT). Additionally,~     the investigators hope to provide clinicians with information on treatment efficacy,~     variables that might influence outcome, and processes that may affect treatment efficacy that~     will guide them in their efforts to treat adolescent BN.~   "
204936|NCT00879138|"~     A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have~     a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and~     osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both~     single and multiple oral doses of VA106483 at three dose levels, under conditions of~     controlled hydration.~   "
204937|NCT00879125|"~     This is a retrospective review of patients who have undergone bariatric surgery at VUMC and~     who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that~     gastric bypass significantly improves diabetes 6-12 months after surgery. The investigators~     are interested in looking at the longer term results after surgery.~   "
204939|NCT00879099|"~     The aim of the study is to investigate the effect of antidepressant paroxetine, on the plasma~     levels of timolol and its main metabolites after topical application of ophthalmic timolol~     products.~      This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy~     male volunteers aged 18 - 40 years will be enrolled.~      Placebo or paroxetine will be given for three days after which 1 drop of timolol product will~     be administered once in both eyes.~      The duration of the paroxetine or placebo treatment period will be 3 days. There will be four~     different treatment periods. A washout between the study periods will be at least 4 weeks.~   "
204940|NCT00879086|"~     The purpose of this study in patients with advanced breast cancer is to compare the incidence~     and severity of neuropathy adverse events for the two treatment groups (eribulin versus~     ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events~     (NCI CTCAE version 3.0) grading.~   "
204941|NCT00879073|"~     The purpose of this study is to:~        -  Test the maximum tolerated dose (MTD) of Bendamustine with whole brain radiation therapy~          (WBRT)~        -  To determine the plasma pharmacokinetics (a blood test to see how much of the drug is~          getting into the patient's system and how long it lasts in the system) of Bendamustine~        -  To determine the presence of Bendamustine in cerebrospinal fluid (CSF) (fluid from the~          brain and spinal cord) of study patients Bendamustine is approved by the Food and Drug~          Administration (FDA) for chronic lymphocytic leukemia. However, Bendamustine will be~          used in this study as an investigational agent.~   "
204942|NCT00879060|"~     Hypertrophic Cardiomyopathy (HCM) is the most common genetic cardiomyopathy and remains the~     leading cause of sudden cardiac death in young people and an important cause of heart failure~     symptoms and death at any age. In HCM, pathological remodeling of the left ventricle~     involving myocardial fibrosis is likely a major contributor to cardiac dysfunction and also a~     nidus for the generation of ventricular arrhythmias. Serum markers of collagen turnover have~     been shown to reliably reflect the magnitude of myocardial fibrosis in a variety of~     cardiovascular diseases. In addition, aldosterone antagonist drugs have been shown to~     decrease fibrous tissue formation in the myocardium in certain pathologic cardiovascular~     states in which aldosterone production is increased. In HCM, aldosterone production is~     up-regulated and has been implicated in the formation of myocardial fibrosis.~      Therefore, the specific aims of this proposal are to:~        1. assess serum markers of collagen turnover at baseline and correlate these findings with~          a variety of clinical and morphologic disease parameters~        2. examine the effects of a 12-month treatment with the aldosterone antagonist~          spironolactone on magnitude of fibrosis as measured by serum markers of collagen~          turnover as well as changes in clinical and morphologic disease parameters.~      The results of this proposal will offer important insights into the clinical significance of~     myocardial fibrosis in this primary genetic cardiomyopathy. The demonstration that~     spironolactone decreases fibrosis and improves clinical course would provide the rational for~     a larger multicenter clinical trial evaluating this novel therapy for improving clinical~     outcome in patients with HCM.~   "
204943|NCT00879047|"~     The proposed studies will examine the extent of pharmacokinetic and pharmacodynamic~     interactions between alcohol and various antiretroviral therapies in those with HIV/AIDS,~     HIV/HCV co-infection, mild HCV and healthy subjects.~   "
204944|NCT00879034|"~     This is an open label single arm feasibility trial. A combination of two oral agents~     (pravastatin and lonafarnib) and one intravenous (IV) agent (zoledronic acid) will be~     administered at doses and schedule currently applied in pediatrics. These agents all target~     farnesylation pathways at different points. Our goal is to inhibit farnesylation of abnormal~     lamin, the disease-causing protein in Hutchinson-Gilford Progeria Syndrome and progeroid~     laminopathies (henceforth progeria). The drugs will include the intravenous bisphosphonate~     zoledronic acid, oral HMG co-reductase inhibitor pravastatin and the oral farnesyltransferase~     inhibitor (FTI) lonafarnib (SCH 66336). Patients with genetically confirmed progeria will be~     eligible for this protocol. Treatment will be initiated for 4 weeks duration and may be~     extended depending on tolerability. This study will assess the feasibility of this treatment~     regimen in the first 4 weeks. If tolerated for 4 weeks, patients can be treated with this~     regimen for up to 6 months.~   "
204945|NCT00879021|"~     This research study will test to see if people who receive pregabalin after their spinal cord~     injury will develop less nerve damage pain than people who do not receive it.~   "
204946|NCT00879008|"~     In this study data of patients with moderate or severe acute exacerbations of chronic~     bronchitis (AECB) were collected. There were two different cohorts which were compared~     (Moxifloxacin and other antibiotics) concerning effectiveness and tolerance. It was a~     prospective study which was accomplished in 100 ambulatory practice offices.~   "
204947|NCT00878995|"~     RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in~     patients with cachexia caused by cancer.~      PURPOSE: This randomized phase I trial is studying whether testosterone administered during~     standard of care chemotherapy and/or radiation works by helping patients with squamous cell~     carcinoma to maintain their body weight and muscle size and strength during treatment.~   "
204948|NCT00878969|"~     The purpose of the study is to see how two classes of blood pressure~     medications,angiotensin-converting enzyme inhibitors (Ace inhibitors) and angiotensin~     receptor blockers (ARBs), differ in their long term effects on certain chemicals in the body~     and on the carotid arteries.~   "
204961|NCT00878800|"~     Open-label, multicentre, dose-escalation Phase I/II study to evaluate safety, efficacy,~     pharmacodynamics, and pharmacokinetics of the combination of PXD101 with doxorubicin~     administered q 3 weeks in patients with advanced solid tumours. Once the Maximum Tolerable~     Dose has been established, up to a total of 20-40 patients with Soft Tissue Sarcoma may be~     enrolled at the MTD dose level to examine efficacy and safety in this specific patient~     population. The trial is stopped if no more than 2 responses are seen among the first 20 of~     these patients.~   "
205122|NCT00876668|"~     The aim of the study is to compare the diagnostic value of this non-invasive vascular imaging~     tool with the established vascular diagnostic methods for PAD in order to get prognostic~     data.~      A higher sensitivity of Fluorescence angiography in order to recognize progression of~     critical limb ischemia could lead to earlier therapeutic interventions and thereby increase~     limb salvage. A diagnostic gap would be closed.~   "
206076|NCT00864045|"~     The purpose of this study is to assess the efficacy and safety of sertindole in patients with~     schizophrenia in Asia.~   "
204949|NCT00878956|"~     With over one million operations a year, cardiac surgery with cardiopulmonary bypass is one~     of the most common major surgical procedures worldwide (1). Acute kidney injury is a common~     and serious postoperative complication of cardiopulmonary bypass and may affect 25% to 50% of~     patients (2-4). Acute kidney injury carries significant costs (4) and is independently~     associated with increased morbidity and mortality (2,3). Even minimal increments in plasma~     creatinine are associated with an increase in mortality (5,6).~      Multiple causes of cardiopulmonary bypass-associated acute kidney injury have been proposed,~     including ischemia-reperfusion, generation of reactive oxygen species, hemolysis and~     activation of inflammatory pathways (7-10). To date, no simple, safe and effective~     intervention to prevent cardiopulmonary bypass-associated acute kidney injury in a broad~     patient population has been found (11-14).~      Urinary acidity may enhance the generation and toxicity of reactive oxygen species induced by~     cardiopulmonary bypass (10,15). Activation of complement during cardiac surgery (16) may also~     participate in kidney injury. Urinary alkalinization may protect from kidney injury induced~     by oxidant substances, iron-mediated free radical pathways, complement activation and tubular~     hemoglobin cast formation (9,17,18). Of note, increasing urinary pH - in combination with~     N-acetylcysteine (19,20) or without (21) - has recently been reported to attenuate acute~     kidney injury in patients undergoing contrast-media infusion.~      In a pilot double-blind, randomized controlled trial the investigators found sodium~     bicarbonate to be efficacious, safe, inexpensive and easy to administer. These findings now~     need to be confirmed or refuted by further clinical investigations in other geographic and~     institutional settings.~      Accordingly, the investigators hypothesized that urinary alkalinization might protect kidney~     function in patients at increased risk of acute kidney injury undergoing cardiopulmonary~     bypass needs to be confirmed in an international multicenter, double-blind, randomized~     controlled trial of intravenous sodium bicarbonate.~   "
204950|NCT00878943|"~     In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in~     pulmonary arterial pressure, cardiac output, quality of life, and other parameters as~     compared to placebo. This protocol provides mechanism for patients who have clinical~     deterioration on other PAH approved therapies to have access to sildenafil prior to marketing~     authorization in India.~   "
204951|NCT00878930|"~     The objectives of this study is to obtain information of Faslodex use in the treatment of~     breast cancer in the clinical practice in Argentina.~   "
204952|NCT00878917|"~     The study aims to prospectively prove the equivalence of the test product and the reference~     solution in lowering intraocular pressure in patients with open angle glaucoma and ocular~     hypertension. For this purpose the patients are randomized into two sequences of study drug~     administration in a crossover study with an adequate wash-out period.~   "
204953|NCT00878904|"~     RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving panobinostat together with epirubicin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when~     given together with epirubicin in treating patients with metastatic malignant solid tumors.~   "
204954|NCT00878891|"~     An increased risk of adverse outcome is noted for diabetic patients admitted in surgery~     intensive care units (ICU). Tight glycemic control with intensive insulin therapy~     dramatically reduces in-hospital mortality and adverse outcome. Devices recording~     continuously interstitial glucose monitoring (CGM) may be an aid in patients of ICU in whom~     normoglycemia become a target.~      The mini-invasive device (Glucoday®) should provide real-time glucose concentrations in order~     to quickly adjust insulin infusion rates. The objective of MARGE study is to compare percent~     of time in normoglycemia based on conventional monitoring (discontinuous glucose monitoring)~     and Glucoday to conventional monitoring alone. The MARGE study is a multicenter (2 centers),~     randomized, single blind trial.~      Several studies have shown that hyperglycemia is associated with poor outcomes in~     hospitalized patients. Postoperative glucose levels are a significant predictor of infection~     rates after cardiac surgery and death rate. Based on these observational studies, a~     randomized controlled intervention trial in surgical ICU patients demonstrated that intensive~     insulin therapy reduced the overall in-hospital mortality by 34 % and stream infection by 46~     %. Using continuous glycemic monitoring (CGM) it has been shown that intensive insulin~     therapy based on discontinuous glucose monitoring revealed that normoglycemia is achieved~     only 22 % of time. The researchers' aim is to determine if real time CGM with a new~     generation mini invasive device, Glucoday® S, would allow quickly adjusting insulin infusions~     rates according to interstitial glucose levels and decreasing both hyperglycemic and~     hypoglycemic excursions. This study will further investigate whether application of real time~     CGM to titrate insulin therapy to target glycemia in a tight range (80-110 mg/dl) can improve~     diabetic patient outcome after coronary artery bypass grafting (CABG).~   "
204955|NCT00878878|"~     The design of this study is to conduct a comprehensive safety evaluation of the pulmonary~     hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac~     catheterization for clinical reasons.~   "
204956|NCT00878865|"~     The objective of the study is to demonstrate the bioequivalence (BE) of two alprazolam 1 mg~     tablets.~   "
204957|NCT00878852|"~     Cannabis use among Spanish adolescents has been increasing in the last decade. It has been~     related to poor school achievement, delinquency, substance use and psychiatric disorders.~     Furthermore, psychoactive substance use in adolescents presenting psychiatric disorders can~     result in the development of substance use disorders or the worsening of psychopathology.~     Thus, there's an urge to develop efficient interventions in the treatment of these disorders.~     Therapeutic approaches based on cognitive-behavioural therapy and motivational interviewing~     have demonstrated a limited efficacy in this population. Programs based on contingency~     management have been reported to be useful both in adult and adolescents, too. But it still~     remains unclear whether a combination of these therapeutic approaches is feasible and brings~     a better cost-benefit relation.~      The investigators' project aims to evaluate the added benefits of supplementing a standard~     intervention on cannabis use, based on combined approach that includes motivational and~     cognitive-behavioural elements, with a contingency management program. Therefore, pre and~     post-treatment evaluation will be carried forward in a sample of 30 adolescents (aged 12-18)~     that initiate treatment for cannabis use related disorder at the Child and Adolescent~     Psychiatry Department of the Hospital Clinic in Barcelona. Participants will be randomly~     assigned to a standard treatment group or an experimental group in which standard treatment~     will be supplemented with a contingency management protocol. As a secondary objective, a~     prospective assessment of neuropsychological performance related to cannabis use or~     abstinence will be carried forward.~   "
204958|NCT00878839|"~     A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g.~     visual acuity) in patients implanted with an AcrySof Toric IOL.~   "
204959|NCT00878826|"~     Enoxaparin is a type of low molecular weight heparin (LMWH), or anticoagulant, used to~     prevent and treat blood clots. Formation of blood clots, or venous thromboemboli (VTE) in~     pregnancy can have dangerous and even life-threatening effects on the mother and fetus.~     Enoxaparin is the preferred medicine to prevent clotting in pregnant patients who are at risk~     for VTE, because it has been studied to be safe and effective in pregnancy without any harms~     to the fetus. Although this medication is routinely used and is recommended by several~     prominent medical groups, the optimal dosing for prevention of VTE is still unclear. The~     range of standardly prescribed dosing regimens of Enoxaparin includes 40mg daily and 1mg/kg~     daily, but these two dosing strategies have never been compared in a head to head fashion.~   "
204962|NCT00878787|"~     Theta-burst transcranial magnetic stimulation (TBS) is a type of repetitive transcranial~     magnetic stimulation (rTMS) method that reduces the excitability of a small region of brain~     for less than one hour. Since dystonia and spasticity may be associated with increased~     excitability of motor cortex, we expect that by reducing the excitability of motor cortex~     with TBS we will temporarily improve these symptoms and hopefully open avenues in the future~     for the use of TBS as a new, non-invasive therapeutic intervention to aid in physical therapy~     and symptom amelioration of dystonia and spasticity. We will test for motor improvement~     during the hour immediately following TBS using tests of muscle function and quality of limb~     movement.~   "
204963|NCT00878774|"~     It is estimated that 36 million Americans suffer from seasonal allergies and that ragweed is~     the primary cause of autumn allergies, 87% of patients with ragweed allergy suffer~     rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide~     desensitising vaccine, currently being developed for the treatment of ragweed allergy.~      The purpose of the present study is to evaluate the safety and tolerability of multiple~     ascending doses of ToleroMune Ragweed in subjects in subjects with a documented history of~     allergic rhinoconjunctivitis on exposure to ragweed pollen. The efficacy of ToleroMune~     Ragweed will also be explored in these subjects using the Late Phase Skin Response, Early~     Phase Skin Response and Conjunctival Provocation Test.~   "
204964|NCT00878761|"~     This Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, single~     followed by multiple dose, dose escalation study designed to evaluate the safety,~     tolerability, pharmacokinetics, immunogenicity, and impact of STX-100 on gene and protein~     expression for αvβ6 related and TGF-β-inducible genes (including tubulointerstitial injury,~     epithelial function, and IF/TA related genes) in renal transplant patients with biopsy.~   "
204965|NCT00878748|"~     This primary purpose of this study is to assess the efficacy and safety of Effexor XR in~     preventing recurrence in Chinese patients with recurrent major depressive disorder (MDD)~     following a 1-year maintenance treatment after an 8-week acute treatment and a 6-month~     continuation treatment phases. The study will also collect data on the prevalence and pattern~     of co-morbid anxiety and somatic symptoms and their impact on the recurrence of depression.~   "
204966|NCT00878735|"~     The purpose of this study is to evaluate the effects of a Zen meditation retreat (Sesshin) on~     psychophysiological parameters in healthy volunteers (regular meditators and non-meditators)~     and in cancer patients and to observe possible changes in the attentional circuitry (through~     functional Magnetic Resonance Imaging- fMRI) and in psychological tests (Beck Anxiety and~     Depression Inventories, Self-Compassion Scale, Mindfulness Attention Awareness Scale, Lipp~     Stress Scale for Adults).~   "
204967|NCT00878722|"~     An open-label, non-randomized, multi-centre, Phase I/II trial to assess the efficacy and~     safety of 2 schedules of PXD101 in combination with idarubicin in patients with AML not~     suitable for standard intensive therapy.~   "
204968|NCT00878709|"~     The purpose of this study is to investigate whether neratinib can further reduce the risk of~     recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment~     with trastuzumab.~   "
204969|NCT00878696|"~     Transcranial magnetic stimulation (TMS) is already broadly used in different areas of~     neuroscience research. Last year, special attention was drawn to TMS in tinnitus. The aim of~     the researchers' study is to investigate the stimulation characteristics of TMS in tinnitus~     patients, in particularly the effect of tonic and burst stimulation of the superior temporal~     lobe.~   "
204970|NCT00878683|"~     This study is a pilot study of the safety, tolerability and efficacy of an investigational~     central venous catheter device used in conjunction with a standard central venous catheter.~     The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will~     reduce catheter colonization by bacteria, and may decrease the rate of catheter-related~     bloodstream infections.~   "
204971|NCT00878670|"~     In this study it will be investigated if patients with atopic dermatitis responding to EPOGAM~     treatment, show a significant increase of dihomo-gamma-linolic acid in the blood.~   "
204972|NCT00878657|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in~     chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving intensity-modulated~     radiation therapy together with gemcitabine may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of~     intensity-modulated radiation therapy and to see how well it works when given together with~     gemcitabine in treating patients with locally advanced pancreatic cancer.~   "
204973|NCT00878644|"~     Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in~     which the body's temperature is lowered and maintained several degrees below normal for a~     period of time, has been used to successfully treat adults who have experienced cardiac~     arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing~     survival rates and reducing the risk of brain injury in infants and children who experience a~     cardiac arrest while out of the hospital.~   "
204974|NCT00878631|"~     This clinical trial will evaluate the ease of conducting a randomized trial on patients with~     severe head injury who are cared for by paramedics in the out of hospital setting. The trial~     will compare two different kinds of fluids that are commonly used to elevate blood pressure~     and minimize the impact of the brain injury. The two solutions are a salt solution of~     different concentrations. One is a normal saline solution similar to the consistency of human~     blood and the other is a higher concentration mixed with a sugar that helps to keep the~     solution in the blood stream longer. This study is conducted without patient consent at the~     time of the study enrolment. The study will report on whether this trial is feasible in the~     out of hospital setting before launching into a larger definitive trial.~   "
204975|NCT00878618|"~     The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the~     oral doses of the extended-release test- and reference formulations of AZD0837 in healthy~     volunteers both in fasting and fed conditions.~   "
205001|NCT00878254|"~     The investigator(s) hypothesize that Rituximab together with combination chemotherapy,~     followed by Rituximab maintenance therapy, will provide better disease control with improved~     response rates and overall survival in patients with previously untreated Mantle Cell~     Lymphoma (MCL).~   "
204976|NCT00878605|"~     The purpose of this clinical trial is to test the effectiveness and safety of a new~     anti-diabetes drug (Cyclo-Z) for the prevention and treatment of Type 2 diabetes. This study~     will determine dose-dependent efficacy and safety of this new drug for the treatment of human~     diabetes. The Food and Drug Administration has granted approval for the use of this~     investigational product to be used in a study [FDA approval (Investigational New Drug) IND #:~     61,897]. This new drug is thought to work by increasing the amount of zinc in your body,~     which in turn should improve your sugar metabolism. If this study successfully proves that~     Cyclo-Z is effective for the treatment of diabetes and is without significant side effects, a~     large, multi-center study of diabetic patients will then be performed.~   "
204977|NCT00878592|"~     This study is to assess value of providing classes about dietary and life style modifications~     to decrease or prevent weight gain, less occurrence or better control of weight gain~     associated disorders such as high blood sugar, hypertension, heart or brain vessels~     problems.Candidates for this study will be those who have got liver transplant within 6~     months of their post transplant period.~   "
204978|NCT00878579|"~     The objective of this study is to evaluate the safety and effectiveness of the PDS System~     compared to the surgical control of posterolateral fusion with autograft and pedicle screw~     fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated~     with degenerative disc disease.~   "
204979|NCT00878566|"~     The purpose of this study is to evaluate the effect of enhanced pharmacist care (patient~     identification, assessment, education, prescribing/titration of antihypertensive medications~     and close follow-up) on systolic blood pressure (BP) reduction in patients with poorly~     controlled hypertension in the community setting.~   "
204980|NCT00878553|"~     SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is~     currently available as Sonata as well as several generic formulations. Sonata and its~     generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is~     designed to become active 2-3 hours after ingestion. It is intended for use in people who~     have no trouble falling to sleep but who often awaken in the middle of the night. This trial~     will determine the best dose to prevent those awakenings.~   "
204981|NCT00878540|"~     The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg~     mirtazapine per day in healthy subjects.~   "
204982|NCT00878527|"~     The purpose of the study is to demonstrate the safety and functionality of the CircuLite~     Synergy Pocket Circulatory Assist Device.~   "
204983|NCT00878514|"~     The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg~     tablet with Xanax® 1 mg tablet under fed conditions.~   "
204984|NCT00878501|"~     The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in~     patients with osteoarthritis of the knee and at what dose. This will be done by comparing the~     effect of AZD1386 to placebo (inactive substance) on pain.~   "
204985|NCT00878475|"~     In patients presenting with acute dyspnea in a pre-hospital setting, the early and correct~     diagnosis may present a significant clinical challenge. Physical examination, chest~     radiography, electrocardiography, and standard biological tests often fail to accurately~     differentiate heart failure (HF) from pulmonary causes of dyspnea. Timely differentiation of~     HF from other causes of dyspnea may permit the early institution of appropriate medical~     therapy. Brain natriuretic peptide (BNP) and amino-terminal pro-brain natriuretic peptide~     (NT-proBNP) have been proposed as early markers of HF and demonstrated to be useful for~     diagnosing and excluding HF in the emergency department. A combination of BNP or NT-proBNP~     testing and standard clinical assessment has been suggested to be superior to either tool~     used in isolation. Some previous studies have also suggested that quantitative capnometry~     (QC) may be useful in differentiating between cardiac and obstructive causes of respiratory~     distress. Therefore, the investigators hypothesized that a new combination of NT-proBNP~     testing, standard clinical assessment, and partial pressure of end-tidal CO2 (PetCO2) would~     optimize evaluation and differentiation of acute dyspnea in a pre-hospital setting.~      The aim of this study was to determine the accuracy of combination of QC, NT-proBNP, and~     clinical assessment in differentiating acute HF from obstructive pulmonary disease~     (COPD/asthma) as a cause of acute dyspnea in pre-hospital emergency setting.~   "
204986|NCT00878462|"~     This trial was a randomized trial to determine a patient's acceptability of unflavored~     antipsychotic medication compared to raspberry flavored antipsychotic medication. Patients~     received 6 total doses of study drug (2 doses of each asenapine formulation) over 3~     consecutive days: 2 different formulations each day, 1 in the morning and 1 in the evening.~     The formulations were: white unflavored, white raspberry flavored, and red raspberry~     flavored. Patients were given a questionnaire following each dose of study medication (one~     questionnaire twice per day for 3 days) to measure how acceptable each formulation was.~   "
204987|NCT00878449|"~     This is a Phase 1 Study Evaluating the Safety of ABT-263 in Combination with~     Etoposide/Cisplatin in Subjects with Small Cell Lung Cancer (SCLC).~   "
204988|NCT00878436|"~     This trial is designed to investigate the safety, dosing schedule, and efficacy of the~     combination treatment of Panobinostat (a histone deacetylase inhibitor) and hormone therapy~     for recurrent prostate cancer. This trial is at its Phase II stage. As of July 23, 2013 Arm B~     was closed to accrual, all the remaining slots in accrual will be allocated to Arm A.~   "
204989|NCT00878423|"~     AT13387/0001 is a dose-finding study of an experimental anticancer agent. In accordance with~     the protocol increasing doses of AT13387 are given to patients with advanced cancer who do~     not have alternative treatment options. The preferred dose of AT13387 will be identified~     according to the side effects experienced at different dose levels.~   "
205036|NCT00877786|"~     Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN) is a research program funded by the~     National Institute of Mental Health and conducted by the UNC Eating Disorders Program and the~     University of Pittsburgh Medical Center. Cognitive Behavioral Therapy (CBT) is an~     evidence-based treatment and the gold-standard for treating bulimia nervosa. The current~     study aims to compare two forms of CBT: face-to-face group therapy and online group therapy~     via cbt4bn.org.~   "
205037|NCT00877773|"~     The goal of this clinical research study is to learn if temsirolimus can help to control~     advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of~     this drug will also be tested.~   "
204990|NCT00878397|"~     Insecticide-treated nets (ITNs), and more recently long lasting insecticide nets (LLINs),~     have been shown to effectively protect those groups most biologically vulnerable to the~     burden of malaria across Africa. However, achieving universal coverage, especially in poor~     and remote areas, has proved a particular challenge and there remains a need to explore~     alternative delivery mechanisms. The recent introduction of universal primary education in~     Kenya has meant that even the poorest households are sending at least one child to school,~     providing a complementary, potentially equitable, mechanism through which to distribute~     LLINs. The delivery of LLINs through schools will be piloted by Population Services~     International in schools situated along the Tana River in North Eastern Kenya. This proposal~     seeks to evaluate the impact of this programme on both household use of school donated, free~     LLINs and the health of schoolchildren. The study hypothesis is that the free delivery of~     long lasting insecticide nets (LLINs) through schools will increase household LLIN coverage~     among younger siblings not enrolled in school and will reduce rates of malaria infection and~     anaemia among school children. The study will be an impact evaluation of a programme~     delivering LLINs through schools, which is to be implemented by Population Services~     International (PSI)-Kenya. The programme will be implemented in 50 schools and due to~     PSI-Kenya's roll out, the programme will be phased in over two years. will be phased in over~     two years. The 50 schools will be randomly divided into two groups, the first 25 schools will~     receive LLINs in 2009 and the second group will receive them in 2010. In each school, five~     households will be randomly selected and household surveys will be conducted to collect~     information on household net use and household demographic and socio-economic status. School~     health surveys will be completed at the end of the programme to assess programme impact on~     malaria infection and anaemia.~   "
204991|NCT00878384|"~     It is still uncertain what the best treatment is for patients who have both atrial~     fibrillation (AF) and heart failure. The aim of the study is to help identify the optimal~     treatment for patients with these two significant medical conditions. This will be performed~     by comparing two alternative strategies for AF management: catheter ablation (to restore~     normal rhythm) and medical therapy (to control heart rate, but not aiming ro restore normal~     rhythm). After random assignment, the effect of each strategy will be assessed by looking for~     changes in exercise capacity, symptoms, heart pump function, and quality of life during 12~     months of follow-up.~   "
204992|NCT00878371|"~     The purpose for this study is to determine if surgery (repair of descending thoracic~     aneurysm) causes a temporary decrease in the Blood Brain Barrier's ability to remove drugs~     from the brain back into the blood. The Blood Brain Barrier surrounds the brain and the~     spinal cord. This Blood Brain Barrier acts as a filter and allows some things to cross into~     the brain and allows other matter to be removed. Studies have shown the Blood Brain Barrier~     is affected by inflammation.~      Functions of the Blood Brain Barrier in animals have been studied. Human studies with~     multiple causes of inflammation (e.g. Alzheimer's, Epilepsy, trauma and severe infections in~     critically~      Hypothesis: Surgically-induced inflammation will temporarily reduce blood-brain barrier drug~     efflux transporter function in proportion to the degree of inflammation. The investigators~     anticipate that inflammation-mediated reductions in drug transporter function will be~     reflected by an increased cerebral spinal fluid (CSF) concentration of morphine (a PGP~     substrate) and M3G and M6G (MRP1 substrates). The corresponding in vitro studies will allow~     us to elucidate the mechanism(s) by which inflammation alters blood brain barrier efflux~     transport of morphine, M3G and M6G.~   "
204993|NCT00878358|"~     Primary objective:~      To compare the effects of short term therapy post total knee replacement (TKR) between a~     hydrotherapy treatment group and a physiotherapy treatment group.~      Secondary objectives:~      To compare the effects of short term therapy post total knee replacement (TKR) between a~     hydrotherapy treatment group and a physiotherapy treatment group based on measurements of~     timed up and go (TUG, as primary outcome), range of motion, pain and quality of life.~   "
204994|NCT00878345|"~     The investigators believe dexmedetomidine will provide superior sedation with reduced side~     effects and reduced time to discharge compared with pentobarbital. The investigators have~     developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory~     procedure center. These protocols are both routinely used for sedation in our unit. The~     investigators propose to study these two protocols in children ages 6 months to 6 years~     presenting to the ambulatory procedure center for non-painful procedural sedation. The~     investigators will compare failure of sedation, side effect profile, recovery and discharge~     times between the two pharmacologic protocols.~   "
204995|NCT00878332|"~     The purpose of this study is to evaluate histologic bone remodeling after interpositional~     bone graft (sandwich osteotomy technique) using xenograft to fill the gap of the bone after~     moving and fixation it in the proper place.~   "
204996|NCT00878319|"~     The purpose of this research study is to compare two different ways of treating a broken arm~     (fractured humerus) using either, the nonoperative approach or the operative, open reduction~     and internal fixation (ORIF). The study will examine which treatment will overall give better~     results in regards to shoulder and elbow function, residual pain and deformity.~      Patients who agree to consent to participation in this study will be randomly selected to~     receive one of the two treatment methods:~        1. Nonoperative: This method requires the application of a plaster sugartong splint for 10~          - 14 days followed by a transition to a functional (coaptation) brace to be worn for 4-6~          weeks. Patients will be followed by physiotherapy from the baseline visit at 2 weeks.~        2. Operative: This treatment option involves an operative procedure for fixation of the~          broken bone with plates and screws (open reduction internal fixation - ORIF). With this~          method of treatment, a splint or sling is worn for comfort postoperatively. The patient~          will be followed by physiotherapy after the post-operative visit at 2 weeks.~      Standard follow-up clinic visits at 2 weeks, 6 weeks, 4 months, 6 months and 12 months will~     be arranged from the date of randomization. The patient will be asked to complete two~     questionnaires, reporting the level of wellbeing and physical function. These questionnaires~     will be given to the patient at the time of baseline visit at 2 weeks and again at 6 weeks, 4~     months, 6 months and 12 months. They should take approximately 10 - 20 minutes to complete.~     At each appointment, the patients will be x-rayed until healing has occurred, examined and~     evaluated (Constant Shoulder Score) by the surgeon and followed by physiotherapy for gentle~     range of motion (ROM) exercises progressing to strengthening and proprioception of the elbow~     and shoulder.~   "
204997|NCT00878306|"~     The purpose of this study is to determine whether disulfiram might be a safe and effective~     treatment for cocaine and/or alcohol dependence in patients with HIV disease. This research~     is designed to characterize the presence or absence of significant drug interactions between~     disulfiram and HIV medications using standard clinical pharmacology techniques as well as~     monitor any side effects that might occur when these medications are administered together.~   "
204998|NCT00878293|"~     The purpose of this trial is to determine whether the new centrally active analgesic and MS~     Continus® are effective in the treatment of painful diabetic polyneuropathy.~   "
204999|NCT00878280|"~     Assess the association of copy number variation (CNV) and inflammatory cytokine with the risk~     of dementia.~   "
205000|NCT00878267|"~     The goal of this research study is to collect information to plan how to design a computer~     program for cancer patients receiving palliative care, their caregivers, and doctors and~     nurses who work in palliative care. Researchers want to learn how to make this program~     practical for use by future patients, caregivers, doctors, and nurses.~   "
205038|NCT00877760|"~     The purpose of this study is to investigate whether it is possible to augment the response of~     patients with HBeAg-positive chronic hepatitis B to entecavir by using a temporary~     peginterferon alpha-2a add-on strategy~   "
205002|NCT00878241|"~     Purpose:~      Evaluation of the CAR™ 27 for the creation of compression anastomoses.~      Indication:~      Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during~     colonic or colorectal resection.~      Study Design:~      Prospective, open labeled study.~      Patient Population:~      Male or female subjects 18 years of age or older who are scheduled for non emergency~     laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy~     can be preformed up to the discretion of the surgeon.~      No. of Subjects:~      15 patients estimated up to three months to enroll.~      Duration of Treatment:~      During the operation - creation of the anastomosis.~      Duration of Follow-up:~      Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic~     visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone~     after 3 months.~      Endpoints:~      To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse~     events related to the use of the CAR™ 27 device.~   "
205003|NCT00878228|"~     The study is a randomized placebo controlled trial to determine whether repeated~     postoperative prophylactic ondansetron (Zofran) administration will prevent postoperative~     and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy.~     Ondansetron will be administered in the intra- and post-operative period. These individuals~     will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of~     postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative~     prophylactic administration of multiple doses of ondansetron (Zofran).~   "
205004|NCT00878215|"~     Image-guided surgery is a new technology, which is used to create 3-D pictures that generate~     a map of the liver. This map will allow surgeons to know the exact anatomical location of~     their instruments, including instances when direct visualization is not possible. This study~     is designed to determine the safety and feasibility of using image-guided techniques for~     treatment of liver tumors. The overall goal of this study is to use image-guided surgery for~     the improvement of the surgeon's ability to remove liver tumors.~   "
205005|NCT00878202|"~     The purpose of the SEDIC study is to test a home based heart failure patient clinical~     follow-up and therapeutic education using telemedicine. This educational follow-up is based~     on an interactive information system (SCAD) including a touch screen personal computer for~     heart failure patient at home. An interactive algorithm has been developed to allow a self~     management teaching to the patient.Furthermore, a specialized nurse provide a clinical data~     follow-up.~   "
205006|NCT00878189|"~     This is a phase 1, dose escalating study to determine the safety of PF-03084014 in patients~     with advanced cancer and leukemia~   "
205007|NCT00878176|"~     The objective of this study is to determine whether bilateral sacral nerve stimulation with~     First stage tined lead placement test is more effective than unilateral stimulation, among~     patients with non obstructive urinary retention.~   "
205008|NCT00878163|"~     This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when~     given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients~     with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs~     used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving GDC-0449 together with erlotinib hydrochloride with or~     without gemcitabine hydrochloride may kill more tumor cells.~   "
205009|NCT00878150|"~     The purpose of this study is to test the effectiveness of a telephone-based and in-person~     Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD)~     following Traumatic Brain Injury. Participants are randomly assigned to receive one of the~     following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).~   "
205010|NCT00878137|"~     The antiphospholipid-antibody syndrome (APLA), which includes lupus anticoagulant,~     anticardiolipin, and anti-beta-2-glycoproteinI antibodies, is a thrombophilic disorder~     associated with arterial thrombosis, venous thrombosis or both. Patients diagnosed with APLA~     have a higher risk of recurrent thrombosis than do patients without known antibodies.~     Currently, warfarin is considered the anticoagulant of choice for prophylactic antithrombotic~     treatment for APLA patients after their first episode of thrombosis. In some patients with~     APLA who are treated with warfarin, the INR values determined on plasma are unreliable due to~     an influence of the APLA on the INR. In these individuals, alternative monitoring methods,~     such as factor II activity, chromogenic factor X activity or prothrombin-proconvertin time~     should be used to assess adequate anticoagulation. These tests are expensive and not widely~     available to some clinicians. Point-of-care (POC) instruments, on the other hand, are readily~     accessible to clinicians. Previous research has shown that INR values from 3 older~     point-of-care (POC) instruments are unreliable in 1/3 of APLA patients (CoaguChekTM,~     ProTimeTM, INRatioTM). However, there are now newer versions of these POC instruments~     available (CoaguChek XSTM, an investigational ProTime device, and a newer INRatioTM device)~     and it is unknown if these newer POC instruments are reliable in patients with APLA. The~     purpose of this study is to determine whether newer POC instruments are reliable in patients~     with APLA.~   "
205011|NCT00878124|"~     As women age the ovarian response and pregnancy rate are reduced while the rate of~     chromosomal abnormalities in the embryos is increased. Oocyte maturation, accurate~     chromosomal segregation as well as early embryo development and implantation are dependent on~     the supply of large amounts of energy, which unlike other cells can only arise from the~     mitochondria. With age the mitochondria becomes less efficient due to damage to its unique~     DNA, resulting in decreased energy production. The proposed study will examine the effect of~     the combination of a dietary supplement, Co enzyme Q10 on pregnancy rate and response of the~     ovaries to a medication that stimulates follicle growth. The investigators hypothesize that~     the improved energetic state of the oocyte would result in a more accurate chromosomal~     separation, increased embryo quality and pregnancy rate.~   "
205012|NCT00878111|"~     The main objective of the trial is to document the safety and antivascular effect of~     escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by~     advanced or metastatic solid tumors not amenable of standard therapies.~      Safety will be established by clinical and laboratory assessment according to NCI-CTCAE~     criteria (version 4.02).~   "
205013|NCT00878098|"~     Background:~        -  In some countries, such as South Africa, the pesticide DDT is an important chemical for~          control of malaria-carrying mosquitoes. However, there is little evidence about the~          effects that it might have on human health.~        -  DDT has been associated with miscarriage and fetal loss in areas with high levels of~          exposure, but more research is needed to determine what levels of exposure are~          associated with loss of pregnancies.~      Objectives:~        -  To examine the relationship between pre-pregnancy levels of DDT in the blood and the~          loss of clinically recognized pregnancies.~        -  To conduct a pilot study to evaluate data collection procedures for future research.~      Eligibility:~        -  Women between 20 and 30 years of age who are not currently pregnant and who reside in~          villages in the Vhembe District in the northeastern part of South Africa.~      Design:~        -  Evaluation of eligibility:~             1. Short physical examination, with questionnaire about medical history, current~               living conditions, and daily life.~             2. Several blood samples will be taken for study and to test for anemia, elevated lead~               levels, malaria, syphilis, and human immunodeficiency virus (HIV).~        -  Half of the women will come from villages that are currently being sprayed with DDT, and~          half will come from villages that are not being sprayed.~        -  Evaluation before and during pregnancy for subjects who become pregnant:~             1. Blood and urine test, including urine pregnancy test.~             2. Questions about recent menstrual history and sexual activity.~             3. Questions about medical history, including treatment for malaria.~        -  Pregnancy follow-up study, including blood draws, will be conducted regardless of~          whether the pregnancy is carried to term.~        -  Researchers will assess and adjust study parameters as needed.~   "
205014|NCT00878085|"~     The investigators will study motor recovery after robot-assisted therapy after stroke. A~     small clinical trial will be conducted to quantify the central nervous system changes~     associated with robotic or standard training, and identify trends across high and low~     responders in terms of patterns of change in cortical activity and type of white matter~     connectivity.The investigators hypothesize that robot training will lead to larger~     improvements as compared to standard occupational therapy. The investigators hypothesize that~     high responders to the robot training will have reduced compensatory activation in the~     bilateral area and will connectivity in the motor tracts.~   "
205015|NCT00878072|"~     This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50~     adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate~     in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose~   "
205016|NCT00878059|"~     This is a research study about how family members make research participation decisions for a~     relative with Alzheimer's or a related dementia. The purpose of this study is to learn more~     about how proxies (the family member who makes decisions for that relative), would think~     through decisions about whether to enroll their relative in studies for not-yet-approved~     medications for Alzheimer's Disease. The long-term goal of the study is to improve the way~     researchers inform families about clinical research studies and opportunities for~     participation. This study is being sponsored by the National Institute on Aging.~      Study participants will be interviewed by a research staff member about research enrollment~     decisions for their relative. A number of standardized questionnaires will be administered.~     There is only one visit required. The interview lasts about three hours. The investigators~     will try to make it as convenient as possible for your schedule.~      This is a non-intervention study. UCSF CHR # H58055-31168-02 v.1 Date: 012709~   "
205017|NCT00878046|"~     The purpose of this study is to determine if the Silent™ hip is effective in the treatment of~     patients with hip joint disease requiring a total hip replacement. Patients who enter the~     study will be evaluated at regular intervals following hip surgery using patient, clinical~     and x-ray assessments. A subset of patients will undergo scans to allow the bone mineral~     density of the bone surrounding the implant to be monitored~   "
205018|NCT00878033|"~     This study investigates the relationship between autonomic dysfunction and chronic~     inflammation in hemodialysis patients.~   "
205019|NCT00878020|"~     The purpose of this study is to evaluate the safety profile, tolerability, and~     pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of~     BMS-819881) in healthy subjects~   "
205020|NCT00878007|"~     While malaria represents one of the main health problems afflicting schoolchildren, the~     evidence base for policy development and programme implementation for school-based malaria~     control remains inadequate. A recent study in western Kenya showed that delivering~     intermittent preventive treatment (IPT) to schoolchildren improved rates of anaemia and~     classroom concentration, but did not improve school performance. This study aims to (i)~     investigate the impact of malaria prevention using a strategy of periodic screening using~     malaria rapid diagnostic tests and treatment positives using artemether-lumefantrine (AL) on~     health and education among schoolchildren and (ii) determine the interaction between health~     and improved literacy instruction. The study hypothesis is that that school-based malaria~     prevention will reduce rates of anaemia or improve educational outcomes in Kenyan~     schoolchildren, when compared to comparison schools. In addition, a programme of training for~     primary school teachers to improve literacy instruction will improve literacy rates and there~     will be no interaction between the malaria intervention and the education intervention, such~     that learning will not be improved when teaching is effective and children are healthy. The~     study will be undertaken in 101 randomly selected primary schools in Kwale District. The~     malaria intervention consists of screening all children using rapid diagnostic tests (RDTs)~     for malaria. Children (with or without clinical malaria symptoms) found to be RDT-positive~     will be treated with AL according to national guidelines. Screening and treatment will be~     administered by district public health staff once a school term, observed by the evaluation~     research team. This intervention has been changed from IPT due to the withdrawal of~     amodiaquine in Kenya. The education intervention includes a programme of training for primary~     school teachers to improve literacy instruction. The study is designed to detect a 25%~     reduction in anaemia and an improvement of 0.2 standard deviations in mathematics and~     literacy tests. Additional outcomes will also be measured including malaria parasitaemia,~     classroom attention and school attendance. Cost-effectiveness and community acceptability of~     the interventions will be assessed. Anaemia and educational outcomes will be assessed before~     interventions and 12 and 24 months later. Malaria parasitaemia using blood slides will only~     be assessed at follow-up.~   "
205021|NCT00877994|"~     Nurture is a collaborative pilot study for mothers of children under the age of 3 who have~     suffered from disordered eating in the past. It is coordinated by the University of North~     Carolina at Chapel Hill, Duke University and Virginia Commonwealth University and sponsored~     by the National Institute of Mental Health. Nurture hopes to promote confident parenting and~     a positive meal times.~   "
205022|NCT00877981|"~     The aim of the present study was to compare open minimal-invasive parathyroid surgery with~     video-assisted parathyroidectomy in primary hyperparathyroidism (PHPT) patients with a~     positive sestamibi scan in a multicentre randomized trial in order to evaluate if~     videoassisted surgery gave less postoperative pain and if there was a difference in operating~     time.~   "
205023|NCT00877968|"~     The objective of this study was to determine if whole yellow pea flour reduces post-prandial~     glycemic responses of novel food products. The second objective was to determine if whole~     yellow pea flour produces food products with favorable sensory characteristics including~     appearance, taste, smell, texture and overall acceptability, compared to corresponding food~     products made with whole wheat flour.~   "
205024|NCT00877955|"~     This study tests the assumption that the bioavailability of alprazolam from a new sublingual~     formulation is the same as that from sublingual formulation expected to be used commercially~     in Brazil.~   "
206459|NCT00858910|"~     The purpose of the study is to examine if patients in the embedded motor imagery (MI)~     training group (EG1) need less time to perform the motor task than patients in the added MI~     training group (EG2).~   "
205025|NCT00877942|"~     Relative risk for many psychiatric disorders differs dramatically in males and females.~     Early-onset disorders, such as autism, occur more often in males; other conditions, such as~     schizophrenia, occur at similar rates in males and females, but the sexes differ in~     expression. It has been hypothesized that the prevalence and expression of these disorders is~     related to sex differences in brain development. X-chromosome effects and early exposure to~     gonadal hormones are strong candidates for a causal role. The aims of the research are (1) to~     characterize sex differences in brain development from birth to age 2; (2) to test whether~     brain development is altered in infants with Turner syndrome, a well-defined genetic disorder~     resulting from the partial or complete loss of one of the sex chromosomes. To address aim 1,~     high resolution MRI, including diffusion tensor imaging (DTI), will be used to characterize~     sex differences in brain development from birth to age 2 in a longitudinal cohort of 250~     children. To address aim 2, high resolution MRI, including DTI, will be used to compare brain~     development in 70 infants with Turner syndrome (X monosomy) to matched controls from aim 1.~     The investigators hypothesize that sex differences in gray and white matter development and~     in white matter maturation as assessed by DTI will be present during the first 2 years of~     life and that children with TS will exhibit abnormal gray and white matter development in the~     neonatal period.~   "
205026|NCT00877929|"~     To demonstrate that the fixed dose combination of telmisartan and amlodipine is more~     effective in lowering blood pressure.~   "
205027|NCT00877903|"~     The objective of the present study is to establish the safety and efficacy of Prochymal®~     following first acute myocardial infarction.~   "
205028|NCT00877890|"~     This study will compare the effects of commercially manufactured exenatide once weekly and~     exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or~     with oral antidiabetic medications. The study will examine glycemic control (as measured by~     HbA1C), safety, and tolerability.~   "
205029|NCT00877877|"~     Infection with human papillomavirus (HPV) has been clearly established as the necessary cause~     of cervical cancer. This study is designed to evaluate the long-term immunogenicity and~     safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV~     vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals~     with objectives & outcome measures of the extension phase from Month 60 to Month 120. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month~     48 are presented in a separate protocol posting (NCT00316706).~   "
205030|NCT00877864|"~     The objective of this study is to determine the effects of supervised combined aerobic and~     resistance training, and the effects of stage-matched written materials delivered by mail or~     internet, alone or in combination, on glycemic control as reflected in A1C (glycated~     hemoglobin).~   "
205031|NCT00877851|"~     Managing diet and physical activity are vital aspects of diabetes self−care; however, people~     with diabetes often find it difficult to make changes to their usual diet and physical~     activity patterns. There is some evidence that computer based education may help some people~     develop the skills they need to better manage their diabetes. The investigators have~     developed an interactive CD−ROM, focusing on knowledge, self−monitoring, goal setting and~     skill−development in relation to diet and physical activity for people with Type 2 diabetes.~     A major emphasis was placed on eliciting the views of people with Type 2 diabetes throughout~     the development of the CD−ROM. This study will examine whether this CD−ROM can improve~     knowledge, skills and self−care behaviour in people with diabetes. One hundred participants~     who have been diagnosed with Type 2 diabetes in the past 2 years will be assigned by chance~     to one of two groups: they will either be assigned to continue with their normal care routine~     consulting with their doctor as normal, or they will be assigned to use the CD−ROM at least~     once a week for 12 weeks.~   "
205032|NCT00877838|"~     The following study is being conducted to explore the safety and effectiveness of a new~     chemical entity called NXN-188 in subjects with a history of migraine with aura. In this~     study subjects will treat two attacks of migraine with aura during the aura phase - once with~     placebo and once with NXN-188.~   "
205033|NCT00877825|"~     Isoflavonoids, through their estrogen-like activity, are in part responsible for the~     cholesterol lowering properties of soy foods. If this is found to be so, then it would be~     advantageous not only to promote soy consumption, but also to identify and use soy cultivars~     with high isoflavonoid content in production of soy food products. These foods may have a use~     in the reduction of serum cholesterol and if they effectively increase the phytoestrogen~     activity of soy, may have a role in the prevention of other hormone dependent diseases (e.g.~     osteoporosis, certain cancers) in the same way as natural estrogens.~   "
205034|NCT00877812|"~     Marginal vitamin B6 deficiency, which occurs commonly worldwide, leads to a cellular~     deficiency of the coenzyme pyridoxal phosphate (PLP). PLP is a coenzyme in several phases of~     one carbon (1C) metabolism, which is the array of reactions in which one carbon units are~     acquired and used in reactions including nucleotide synthesis, regeneration of methionine~     (Met) from homocysteine (Hcy), and methylation of many biological compounds. 1C metabolism is~     linked to the transsulfuration pathway in which Hcy undergoes PLP-dependent catabolism~     leading to cysteine, whose availability governs the formation of the antioxidant glutathione.~     Nutritional or genetic conditions that impair 1C metabolism are associated with elevation in~     plasma Hcy concentration and increased risk of vascular disease. It is believed that the~     metabolic effects of vitamin B6 deficiency will be most pronounced following protein intake~     when the vitamin B6-dependent pathways of amino acid metabolism experience the greatest~     substrate load. The human subjects protocols of this study consist of two distinct phases~     intended to extend our understanding of basic human 1C metabolism and the effects of marginal~     vitamin B6 deficiency under postprandial conditions. Phase 1 will investigate the effects of~     vitamin B6 nutrition on the PLP-dependent generation of 1C units by the glycine cleavage~     system and on the synthesis of glutathione. Phase 2 will investigate the dependence of~     methionine metabolism on vitamin B6 nutritional status, with particular emphasis on the~     recycling of Hcy to Met. Each phase of this study will involve 14 healthy, nutritionally~     adequate, young adults (7 male, 7 female) who will undergo metabolite profiling and kinetic~     analysis using intravenously infused stable isotopic tracers performed both before and after~     a ~4-week period of dietary vitamin B6 restriction. Subjects will be assigned to either Phase~     1 or Phase 2, which will be identical in design except for the tracers and analytical methods~     used. We hypothesize that vitamin B6 deficiency will yield reduction in postprandial rates of~     homocysteine remethylation, generation of 1C units from glycine, and synthesis of~     glutathione. The results of this study will aid in assessing the consequences of nutritional~     and genetic variables affecting human metabolism and will further our understanding of the~     relationships between vitamin B6 nutrition and disease.~   "
205035|NCT00877799|"~     The purpose of this study is to determine the effectiveness and safety of single intravenous~     doses of the kappa opioid agonist CR845 in relieving pain in patients following~     laparoscopic-assisted hysterectomy surgery. The study protocol was divided into two parts~     with subjects either dosed with study drug the day following surgery (Cohort 1), or~     immediately after surgery (Cohort 2).~   "
205039|NCT00877747|"~     Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in~     advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin),~     bleomycin, vinblastine and dacarbazine (ABVD). Two-year Progression Free Survival of PET-2~     positive patients is only 12%, but the optimal treatment for this patient subset is still~     unknown.~      From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early~     intensification of chemotherapy with BEACOPP [Bleomycin, Etoposide, Adriamycin (doxorubicin),~     Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone](4 escalated + 4~     baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The~     investigators retrospectively recorded and analyzed these data in order to evaluate if this~     strategy could be of benefit for this subset of patients.~   "
205040|NCT00877734|"~     This is a study of the efficacy and safety of baclofen for alcohol dependence. 80 outpatient~     subjects with DSM-IV alcohol dependence will be randomized to 10 mg three times a day (tid)~     baclofen or tid placebo. An effort will be made to recruit 40 men and 40 women. Subjects will~     receive BRENDA counseling over the 12 weeks of the trial. The Timeline Followback (TLFB)~     method will be used to assess drinking patterns. The primary outcome is % heavy drinking~     during the trial.~   "
205041|NCT00877721|"~     Experimental design overview:~      The proposed project is a prospective experimental study design. Independent old adults (age~     65 years old and older) who suffer from minor balance problems willing to participate in the~     study will be tested with well-established measuring techniques of balance and gait before~     and 4 weeks after balance training program using the Self Mobility Improvement in the~     Elderly by Counteracting Falls system (SMILING system). The study design is randomized~     clinical trial (RCT), cross over, single blinded study design where 30 subjects will randomly~     be allocated into experimental or control groups that will switch groups after 4 weeks of~     intervention.~      Random sequence generation will be performed by a staff member who will not interact with~     subjects during the balance-testing sessions. Subjects will be informed that they are to be~     randomly assigned to one of the two groups, both receiving gait training program.~      The staff member who administers the training programs will be the only member of the~     research team aware of the subjects' group allocations.~      A 'blinded' research assistant will administer the balance tests and will perform any data~     processing that involves subjective judgments.~      Scripts will be used during testing to ensure that all subjects receive the same~     instructions.~      Testing session between two training periods (T1) will take one week.~   "
205042|NCT00877708|"~     The purpose of this study is to review patients with E. coli infections at UPMC from~     September 1, 2008 to August 31, 2010 to determine if these infections have arisen in the~     community rather than in hospitals or nursing homes and determine their clinical outcomes.~      The specific aims of this study are to:~        1. Review whether cephalosporin-resistant E. coli infections are hospital-acquired,~          healthcare-associated or community-associated.~        2. Determine the clinical outcome of the patients according to the antibiotics given.~   "
205043|NCT00877695|"~     The purpose of this study is to develop and pilot test a culturally and developmentally~     tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal~     sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).~   "
205044|NCT00877682|"~     The goal of this clinical research study is to learn if using cryotherapy to treat only the~     part of the prostate that contains cancer is an effective treatment for prostate cancer. The~     safety of this treatment will also be studied. Researchers also want to learn if treating~     only the part of the prostate with cancer causes less impact on your quality of life than~     other types of therapies.~   "
205045|NCT00877669|"~     The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser~     Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the~     Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).~   "
205046|NCT00877656|"~     The purpose of this study is to assess the safety and efficacy of treatment of non-cutaneous~     T-cell lymphoma with treatment with CD4.~   "
205047|NCT00877643|"~     The purpose of this study is to investigate whether in patients with early persistent atrial~     fibrillation and mild to moderate early heart failure an aggressive upstream rhythm control~     approach, including aldosterone receptor antagonists and statins, dietary restrictions,~     counseling and cardiac rehabilitation programs, increases persistence of sinus rhythm~     compared with conventional rhythm control after one year of follow-up.~      A randomized long term extension of the RACE 3 will be performed with a total follow-up of 5~     years to investigate the long term effects on persistence of sinus rhythm and cardiovascular~     morbidity and mortality of the two treatment strategies.~   "
205048|NCT00877630|"~     The investigators had performed more than 250 cases of breast approach endoscopic~     thyroidectomy (BAET). The goal of this study is to evaluate whether BAET could be a minimally~     invasive procedure under the expert's hands.~   "
205049|NCT00877617|"~     Primary Objectives:~        1. To describe patient quality of life (QOL) related to bladder, bowel, and sexual~          function, as well as mental and physical health, in patients who received neoadjuvant~          investigational therapies prior to radical prostatectomy (RP) for high risk clinically~          localized prostate cancer (HRCLPC).~        2. To identify medical and demographic variables that are related with quality of life,~          e.g., hormonal or non-hormonal neoadjuvant treatment, time since surgery, disease~          recurrence, subsequent treatment, age, ethnicity, and socioeconomic status.~      Secondary Objectives:~      1. To describe treatment satisfaction expressed by patients who have received neoadjuvant~     investigational therapies prior to radical prostatectomy for high risk clinically localized~     prostate cancer.~   "
205064|NCT00877422|"~     Pneumonia is the fourth leading cause of death and frequently occurs in institutionalized~     elderly people in Japan. Recently, several clinical and experimental studies have reported~     the importance of vitamin D in the regulation of immune functions and its deficiency is~     associated with susceptibility to some infections. In the present study, the investigators~     hypothesize that deficiency of serum vitamin D is associated with development of pneumonia,~     and supplementation of vitamin D may lower the incidence of pneumonia and prolong survival in~     institutionalized elderly subjects.~   "
205065|NCT00877409|"~     The objective of this study is to establish the safety in use of the topical drug Acnase~     Creme and its effectiveness in treatment of acne grade I (comedones) and II (comedones,~     papules, pustules).~   "
205050|NCT00877604|"~     The preclinical rationale for tauroursodeoxycholic acid (TUDCA) use in treating patients with~     amyotrophic lateral sclerosis (ALS) stems from the demonstration of antioxidant,~     antiapoptotic and neuroprotective properties of TUDCA in the central nervous system (CNS),~     both in vitro and in vivo models.~      This protocol is meant for assessing if the addition of TUDCA to the conventional therapy can~     improve the therapeutic outcome in patients affected by ALS.~      Safety will be assessed for all subjects, for the entire duration of the study. 30 patients~     affected by ALS with site of onset in the limbs will be recruited.~      All enrolled subjects will continue receiving riluzole at the same regimen as before entering~     the trial. Based on an appropriate random code, subjects will be divided into two groups of~     equal size treated, after a lead-in period of 3 months, by oral route with TUDCA at the dose~     2 g daily for 1 year or with identical placebo by oral route at the same dosing schedule,~     under double-blind conditions.~      Every concomitant and/or supportive therapy will be admitted.~      Evaluation criteria:~      Efficacy. The proportion of responder patients in the two treatment groups was the primary~     outcome measure of the study. Responder patients were defined as those subjects showing an~     improvement of at least 15% in the ALSFRS-R (2) slope during the treatment period as compared~     to the lead-in period. This threshold was chosen based according to the consensus conference~     on designing and implementing clinical trials in ALS (3).~      Other parameters will include ALSFRS-R at study end, FVC%, the SF-36 quality of life rating~     scale, time to tracheotomy from starting of study medication dosing (if appropriate),~     survival Time from starting of study medication dosing (if appropriate), Medical Research~     Council scores for right and left muscle groups.~      Safety. Incidence, severity and type of adverse events; changes in clinical laboratory~     findings.~   "
205051|NCT00877591|"~     The purpose of this study is to examine the interactions of buprenorphine-naloxone, a~     medication used to treat opiate (heroin or prescription narcotic) dependence, and medications~     used in the treatment of HIV disease including atazanavir (Reyataz), fosamprenavir (Lexiva),~     didanosine (Videx), tenofovir (Viread), atazanavir (Reyataz)/ritonavir (Norvir),~     fosamprenavir (Lexiva)/ritonavir (Norvir), lamivudine (Epivir), or darunavir (please note~     that we have completed drug interaction studies for buprenorphine with atazanavir,~     atazanavir/ritonavir, didanosine, tenofovir and lamivudine) at the PI's previous university;~     for this CHR application only the studies needed to be completed at UCSF/SFGH will be~     discussed) or tuberculosis(TB) (rifampin or rifabutin) medications (note: supplement~     application currently pending). Participants are those with opioid dependence who qualify for~     buprenorphine/naloxone treatment or they are healthy subjects without opioid dependence who~     participate in pharmacokinetics studies of the antiretroviral medications. A total of 160~     such individuals will be enrolled in these studies (please note that the studies have been~     ongoing at Virginia Commonwealth University for 3 years so that the total number of~     participants to be recruited at UCSF/SFGH will be about 50 protocol completers). Participants~     take the HIV or tuberculosis medicine(s) for up to 15 days (depending on the medication(s)~     administered and ability to schedule blood and urine sampling sessions).~   "
205052|NCT00877578|"~     The aim of this study is to evaluate in malnourished elderly patients the nutritional~     efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients~     (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density~     and palatability.~      The primary endpoint is the outcome of fat-free mass measured by multiple frequence~     bio-impedance analysis.~   "
205053|NCT00877565|"~     Systolic function is a substantial determinant of overall hemodynamics and organ function.~      Therefore assessment of left ventricular systolic function (LVF) has been of central interest~     in Echocardiography. Ejection fraction (EF) measurement has been the gold standard~     echo-derived measure to describe LVF. However, EF is a blood pool derived and therefore load~     dependent measure.~      Global longitudinal peak systolic strain average is a new parameter derived from speckle~     tracking tachnique. As a primarily myocardial deformation parameter it is considered to be an~     equivalent to EF measurement, but maybe less load dependend. The aim of the study is to~     investigate the reliability of GLPSS average to quantify LVF in the perioperative setting (in~     cardiac and non-cardiac cases).~   "
205054|NCT00877552|"~     The purpose of this study is to use structural and functional magnetic resonance imaging~     (MRI) to study children at high risk for schizophrenia. It is hypothesized that children at~     high risk for schizophrenia will have abnormalities of brain development, especially of the~     cerebral cortex. The study will also describe normal brain development in children from birth~     to age 6 years~   "
205055|NCT00877539|"~     PF-03526299, a novel anti-inflammatory agent should attenuate the effect of a bronchial~     allergen challenge on lung function and hence provide proof of mechanism for this agent.~   "
205056|NCT00877526|"~     This study is conducted in Asia. The aim of this observational study is to evaluate current~     status of diabetes management, control, and complications in diabetic subjects in Asia.~   "
205057|NCT00877513|"~     Cigarette smoking increases CVD risk and worsens insulin resistance, but also contributes to~     weight loss; smoking cessation reduces CVD risk and improves insulin sensitivity, but also~     contributes to weight gain. The mechanisms that underlie these metabolic changes of cigarette~     smoking and smoking cessation on insulin resistance, body composition, and fat distribution~     are poorly understood.~   "
205058|NCT00877500|"~     The goal of this clinical research study is to learn about certain genes and proteins in~     tumors that do not respond well to treatment. These features will be compared with the status~     of the disease after surgery for breast cancer that does not express the HER2 protein, when~     patients either receive or do not receive ixabepilone. The safety of ixabepilone in this~     group of patients will also be studied.~   "
205059|NCT00877487|"~     The primary objective of this study is to evaluate the maintenance of efficacy, as measured~     by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global~     Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects~     with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and~     are maintained on their screening dose of commercial SPD489.~   "
205060|NCT00877474|"~     This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic~     study of PM01183 for patients with advanced solid tumors~   "
205061|NCT00877461|"~     According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of~     fingertips and vein as samples to evaluate the accuracy of portable BGM.~   "
205062|NCT00877448|"~     A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety~     study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy~     volunteers.~   "
205063|NCT00877435|"~     The purpose of this study is to determine whether prize-based contingency management~     (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment~     of of cocaine-dependent patients compared to CBT only. Patients were randomized to prizeCM +~     CBT (experimental group) or to CBT (control group) an treated over 24 weeks. It is the first~     trial of this type in Europe.~   "
205066|NCT00877396|"~     The goal of this randomized clinical trial is to determine whether immunizing children in~     Hutterite colonies with inactivated influenza vaccine can prevent influenza and its~     complications in other colony members. Furthermore, the study will assess the indirect~     benefit to Hutterites at high risk of complications. The study is a blinded, cluster~     randomized controlled trial among Hutterite colonies to test the hypothesis that high~     immunization rates (>70%) of healthy children with inactivated influenza vaccine reduces~     transmission of influenza to other colony members. Randomization of these homogeneous,~     moderately sized colonies where there is regular spread facilitated by a communal lifestyle,~     but limited re-introduction because of relative isolation from outside community, represents~     a unique opportunity to test the hypothesis of indirect benefit under close to ideal~     conditions. The primary outcome will be laboratory-confirmed influenza. Secondary outcomes~     include influenza-like illness, otitis media, physician visits, antimicrobial prescriptions,~     absenteeism, lower respiratory tract infection, hospitalizations, and death.~   "
205067|NCT00877383|"~     This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when~     combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients~     with chronic obstructive pulmonary disease (COPD).~   "
205068|NCT00877370|"~     Critically ill patients in the intensive care unit often receive continuous hemodialysis to~     treat their kidney failure. Ertapenem is an antibiotic often used in these patients.~     Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate~     treatment of their infection. This study will determine how much ertapenem is removed by~     continuous hemodialysis.~   "
205069|NCT00877357|"~     A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the~     safety, immunogenicity (short term and long term) and clinical consistency of three~     production lots of the vaccine.~   "
205070|NCT00877344|"~     Hypothesis~      Intrauterine contraception placed immediately after a second trimester abortion will result~     in fewer pregnancies than current standard practice of intended placement at 4 weeks~     post-abortion.~      Study Design~      Randomized Controlled Trial after their second trimester abortion comparing immediate with~     delayed insertion of IUC, and a non intervention control group choosing non-intrauterine~     contraception. Participants choosing an IUC will be randomly assigned to immediate or delayed~     insertion. The investigators primary outcome is pregnancy rate within one year.~   "
205071|NCT00877331|"~     This study will examine the effectiveness of a brief intervention in a primary care setting~     to reduce drug use or abuse compared to enhanced care as usual.~   "
205072|NCT00877318|"~     The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at~     home with clinical follow-up, therapeutic education, and advice on the training at the~     stamina, via telemedicine with the classic strategy in day hospital.~   "
205073|NCT00877305|"~     The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on~     cognitive function in patients undergoing cardiac surgery compared to control intervention.~   "
205074|NCT00877292|"~     The study will examine the sensitivity and specificity of a circulating cell-free nucleic~     acid test (DNA/RNA) to identify Down syndrome between about 10 weeks and 21 weeks 6 days~     gestation. In addition, the new test may be used to identify trisomy 13 and 18 as part of a~     more complete laboratory developed test. We hypothesize that the new circulating cell-free~     fetal NA-based test will accurately and precisely measure specific fetal markers in maternal~     circulation and that measurement will lead to the ability to noninvasively identify with high~     sensitivity and specificity, fetal chromosome abnormalities, such as Down syndrome.~   "
205075|NCT00877279|"~     This study is to determine the safety and effectiveness of Belotero® Soft compared to active~     comparator in the correction of mild facial wrinkles, such as nasolabial folds.~   "
205076|NCT00877266|"~     This research study is to determine the relative times for perineural catheter placement with~     the use of ultrasound versus electrical stimulation. The perineural catheter is placed next~     to the nerves through which local anesthetic is placed to provide pain control following~     surgery. This study may determine if one method is associated with increased success rate and~     patient comfort.~   "
205077|NCT00877253|"~     The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus~     Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in~     subjects with advanced ovarian cancer.~   "
205078|NCT00877240|"~     The goal of this study is to determine the effectiveness of a general intervention that~     includes encouragement of physical activity and healthy living habits of officers and~     permanent staff in the IDF~   "
205079|NCT00877227|"~     The purpose of this study is to determine whether supplementation with folinic acid, a B~     vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine~     concentrations are associated with an increased risk of cerebrovascular accidents in adult,~     children and newborns. These increased concentrations can easily and safely be lowered by~     folic acid in adults.~   "
205080|NCT00877214|"~     The purpose of this study is to determine if an extended maintenance therapy with Rituximab~     in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has~     advantages compared to a shorter or no maintenance therapy.~   "
205081|NCT00877201|"~     The purpose of this study is to determine the antioxidant supplementation effect on~     accommodation among visual display terminal (VDT) users.~   "
205082|NCT00877188|"~     The purpose of this study is to evaluate the effects of a combined aerobic and resistance~     exercise program in breast cancer survivors.~   "
205083|NCT00877175|"~     The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1%~     tropicamide by conventional instillation and lower conjunctival fornix packing in premature~     infants.~   "
205117|NCT00876733|"~     This observational study is supposed to assess (under conditions of clinical practice in~     daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g.~     Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir~     and emtricitabine) will durably suppress viral load below the limit of detection or will~     maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under~     previous anti-retroviral combination therapy after switch to combination treatment of~     Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir~     and Lamivudine) or Truvada (tenofovir and emtricitabine).~   "
205084|NCT00877162|"~     Night waking with crying can be a distressing and difficult experience for infants and their~     parents. The investigators want to reduce infant night waking and crying and improve parents'~     views of their infants' sleep. This study will help the investigators determine whether~     parents who receive group teaching about infant sleep and follow-up phone calls provided by~     Public Health Nurses will reduce numbers of infants' night wakes and parents' perceptions of~     infant sleep difficulties compared with parents who receive a group teaching about infant~     safety and follow-up phone calls provided by Public Health Nurses. Results from this study~     will help the investigators improve their practice when assisting parents and infants with~     sleep problems.~   "
205085|NCT00877149|"~     The purpose of this trial is to provide data of absence of inflammation in patient liver~     histology after long-term telbivudine treatment and thus help investigators to make a~     comprehensive judgment on treatment discontinuation in selected patients~   "
205086|NCT00877136|"~     This is an interdisciplinary study that falls into the Humanitarian Use Device category.~     There are no hypotheses to be tested in this treatment protocol. The study has the following~     objectives:~        1. Provide supervised access to treatment with TheraSphere® to eligible patients with~          primary cancer to the liver who are not surgical resection candidates.~        2. Evaluate patient experience and toxicities associated with TheraSphere® treatment.~        3. Measure tumor response rates~   "
205087|NCT00877123|"~     Obesity, and its metabolic consequences - impaired fasting glucose (IFG) and diabetes, is~     highly prevalent among Arab women in Israel and the Middle East. Since life style~     modification is difficult to achieve in this population it is important to assess whether~     other modifiable risk factors can be detected. There is evidence that the homeostasis of~     vitamin D has a significant role in the eventual development of diabetes. Previous cross~     sectional studies have shown that low 25 (OH) vitamin D levels are related to glucose~     intolerance, diabetes, insulin resistance and metabolic syndrome. The study hypothesis is~     that 25(OH) vitamin D deficiency is highly prevalent among Arab women with IFG and that~     vitamin D supplementation may improve IFG and by that reduce the risk for future overt~     diabetes. Additionally, obesity is associated with a low-grade inflammation of white adipose~     tissue (WAT) resulting from chronic activation of the innate immune system. In obesity, there~     is an increased production and secretion of a wide range of inflammatory molecules including~     interleukin-10 (IL-10), which may have systemic effects on WAT and other organs. To that end~     the investigators will assess the influence of vitamin D supplementation on IL-10 and hs-CRP.~   "
205088|NCT00877110|"~     Funding Source - FDA OOPD FDR004128~      The goal of this study is to see if it is safe and feasible to give chemotherapy, natural~     killer (NK) cells, and an antibody called 3F8. The NK cells must come from a family member~     who shares half of the HLA proteins which are immune proteins important in transplant. NK~     cells are a type of white blood cell. They can recognize and kill abnormal cells in the body~     and can work together with antibodies to kill target cells. The antibody 3F8 specifically~     recognizes a protein present on the target cancer cell.~   "
205089|NCT00877097|"~     Recent studies suggest that the combination of two inhibitors of bone resorption may induce a~     greater increase in bone mineral density (BMD) than either agent alone.~      In this 5-year partly randomized study the investigators examined the effects of hormone~     therapy (HT) with or without bisphosphonate on BMD on osteoporotic women.~      In the Kuopio Osteoporosis Study (OSTPRE) a population based sample of 3200 women were~     selected for BMD measurement by Lunar DPX in 1995-1997. In all 167 women aged 61±2.7 years~     (11±4.9 years postmenopausal), and the T-score < -2.5 SD at either the lumbar spine or~     femoral neck were recruited for this sub-study.~      They received daily estradiol hemihydrate (E2) 2mg + norethisterone acetate (NETA) 1mg~     (Kliogest®, Novo Nordisk, Denmark) and were randomized to get additional Boneplac, which~     consisted of either 800mg clodronate (Bonefos®, Leiras Ltd, Finland) (n=55, KB-group) or~     placebo (n=55, K-group). In case of contraindications or refusal from HT, the women were~     offered clodronate 800 mg/day (n=57, B-group) to be taken to empty stomach with a glass of~     water 30 minutes to two hours before breakfast.~      BMD was measured at time intervals 0, 1, 3 and 5-years. All repeated BMD values were~     interviewed by one investigator and primarily the vertebrae L2-L4 were followed. In case of~     spinal deformities during the study (38.3%) other lumbar levels were followed. The baseline~     BMD values (lumbar spine BMD 0.839±0.072 g/cm², femoral neck BMD 0.759±0.094g/cm²) were~     similar between the groups.~   "
205090|NCT00877084|"~     When patients with chronic obstructive lung disease (COPD) are admitted to the hospital with~     a severe exacerbation they lose muscle strength. This muscle weakness predisposes these~     patients to further hospital admissions. Resistance training is a potent countermeasure to~     prevent and treat muscle weakness. In the setting of an acute exacerbation this intervention~     however has not been validated.~      The present study aims at investigating the safety and efficacy of resistance training (3x8~     quadriceps extensions per day) to prevent muscle weakness. End points are quadriceps muscle~     strength and hospital readmission and functional status at discharge. Using the minimally~     invasive needle muscle biopsy technique described by Bergström the effects of resistance~     training on the skeletal muscle will be analyzed in detail.~      After giving informed consent, patients will be randomized on admission into usual care or~     usual care plus resistance training. Patients will be followed-up using the clinical pathway~     for COPD (10 days). After one month patients will attend the outpatient clinic for a~     follow-up visit. Besides the measurement prescribed in the clinical path for COPD (including~     arterial blood gas measures, lung function, functional investigation of the patients),~     patients will undergo muscle strength measures and venous blood will be drawn for the~     analysis of systemic inflammatory and growth factors. Half of the patients will receive a~     resistance training program. At the end of the hospital admission, a needle biopsy of the~     vastus lateralis muscle will be obtained.~   "
205091|NCT00877071|"~     Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic~     options. Patients who present with HCC beyond the currently accepted Milan criteria are not~     eligible to be listed for liver transplantation. The proposed study offers local regional~     therapy to a defined population of patients beyond Milan criteria as an attempt to downstage~     them to eligibility for liver transplant.~   "
205118|NCT00876720|"~     Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by~     hearing loss and leading to the phantom auditory perception of sound in the absence of an~     external or internal acoustic stimulus.~   "
205092|NCT00877058|"~     The present study Elderly person in the risk zone form part of the research programme~     Support for frail elderly persons - from prevention to palliation (www.~     Vardalinstitutet.net) which comprises research into three interventions. A fundamental~     principle in the research programme is that it comprises interventions addressing frail~     elderly person in different phases of the disablement process, from elderly persons who are~     beginning to develop frailty to very frail elderly persons receiving palliative care in the~     final period of their lives. The interventions also address the different requirements that~     arise with regard to professional contributions during the various phases of the ageing and~     disease process, ranging from health promotion to a need for an increasing degree of medical~     care, nursing, special care and rehabilitation, and finally, efforts that promote symptom~     relief, quality of life, security and satisfaction with care during the final period of life.~     The intervention Elderly persons in the risk zone addresses elderly persons that are on the~     point of developing frailty (pre-frail) and are beginning to feel that they are being~     hindered from taking part in everyday activities. The hypothesis is that if an intervention~     is made when the persons are not so frail, it is possible to prevent/delay deterioration.~        1. Can a health-promoting and preventive intervention for prefrail elderly persons:~             -  prevent frailty, activity limitations and morbidity,~             -  be a supportive factor in the social and physical environment,~             -  affect life satisfaction~             -  have an impact on the consumption of care~             -  be cost-effective?~        2. How do the frail elderly persons experience the intervention and its importance to~          health?~   "
205093|NCT00877045|"~     This is a retrospective medical record abstraction to evaluate the patterns of care for~     Gastrointestinal stromal tumors (GIST) in the community setting. Patient demographics and~     characteristics along with the treatments received will be described. Investigators will~     establish the percentage of patients who undergo surgery, the percentage of patients who are~     treated with kinase inhibitors as well as in what setting (adjuvant or metastatic) as well as~     the duration of therapy. Physician information will also be collected to assess for~     differences in treatment based on physician or geographical differences.~   "
205094|NCT00877032|"~     The purpose of this study is to determine the safety and tolerability of RN6G in patients~     with dry, age-related macular degeneration.~   "
205095|NCT00877019|"~     Aim:~      The study was designed to test the time dependent efficacy in plaque removal of four~     toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B)~     brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D)~     and.~      Materials and Methods:~      The study was a single-blind, randomized clinical timer study consisting of four identical~     experiments testing each brush in one quadrant. The distribution of the quadrants and brushes~     was randomized so that always all brushes were used within one participant. The teeth were~     brushed by a dental hygienist for 10, 20, 30, 45, 60 und 90 seconds per quadrant. No~     toothpaste was used throughout this study. The plaque assessment (Tureskey modified QHI) was~     done after each time interval blinded on six sites per tooth by a separate investigator.~     Ninety subjects participated in the study and received a professional prophylaxis prior to~     the experiment. They were requested to refrain from brushing their teeth for 48 hours prior~     to the experiment.~   "
205096|NCT00877006|"~     The primary objective of the study is to compare the complete response (CR) rate of~     bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab,~     cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide,~     doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent~     non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL).~   "
205097|NCT00876993|"~     Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity~     in a variety of central nervous system tumors. No prospective studies have been published or~     are currently in progress within the major consortiums with this combination of drugs. Brain~     tumors are the second most common cause of cancer in pediatrics and the leading cause of~     cancer death in children. For children with High Grade Gliomas or with relapsed/refractory~     brain tumors, new agents in new combinations are needed. Historical data shows that newly~     diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant~     gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%.~     This study is a phase I study designed to provide an objective observation of toxicity and~     establish a maximum tolerated dose of this combination. In addition, this study will observe~     the response of children with relapsed or refractory central nervous system tumors.~   "
205098|NCT00876980|"~     The investigators hypothesize that obstructive sleep apnea (OSA) contributes to impaired~     glucose homeostasis and associated vasculopathy, and nCPAP treatment of OSA should improve~     glycemic control and vascular function in OSA patients with type II diabetes mellitus. This~     study aims to investigate the therapeutic effects of nCPAP on glycemic control and vascular~     function in patients with OSA and type II diabetes mellitus.~   "
205099|NCT00876967|"~     The purpose of this study is to determinate if there is a difference in performance provided~     by three laryngoscope blades: plastic single use, metallic single use and metallic reusable~     blades.~   "
205100|NCT00876954|"~     The investigators hypothesize that preoperative hyperthermia improves postoperative~     complications and compare a placebo group with standard thermoregulatory management~     (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core~     temperature) in a randomized, single blinded, controlled trial.~   "
205101|NCT00876941|"~     The objective of this study is to test whether screening and brief intervention for drug use~     among primary care patients leads to improved drug-related outcomes (such as decreased drug~     use and consequences).~   "
205102|NCT00876928|"~     Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D~     levels will delay the development of diabetes.~   "
205103|NCT00876915|"~     Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots,~     also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can~     occasionally be life-threatening. The purpose of this study is to determine if a daily~     injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the~     frequency of blood clots. Dalteparin is currently approved for prevention of blood clots~     following surgery and in hospitalized patients but not specifically for cancer outpatients.~   "
205104|NCT00876902|"~     The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of~     ischemia reperfusion injury following liver transplantation by administering YSPSL into the~     liver graft directly ex vivo via the portal vein and to the recipient intravenously prior to~     reperfusion. This study is an extension of the recent pilot study YSPSL-0002 with an almost~     identical study protocol. The rationale of this and the previous study is based on the recent~     observation that P-selectin expression has been associated in liver grafts with prolonged~     cold storage times and rejection. By examining biomarkers of IRI including P-selectin by~     immunohistochemistry and/or quantitative PCR, liver histology and hepatic blood flow using~     established techniques, the goal of this study is to evaluate the feasibility of using these~     modalities for future studies of safety and efficacy.~   "
205105|NCT00876889|"~     The purpose of the study is to find out if the use of the drug Riluzole is both safe and~     improves outcome in patients with acute traumatic spinal cord injury (SCI).~   "
205106|NCT00876876|"~     To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is~     maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo~     during the 4 week double blind treatment period.~   "
205107|NCT00876863|"~     The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment~     of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells~     in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve~     Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect~     them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has~     been carefully studied in laboratory animals and is in the early stages of being tested in~     people.~      Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half~     of the study subjects will have CERE-110 injected into the brain during a surgical procedure,~     while the other half will undergo a placebo surgery where no medication will be injected.~     All study participants will be followed for at least two years after surgery.~   "
205108|NCT00876850|"~     A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of~     complicated skin and skin structure infections (cSSSI).~   "
205109|NCT00876837|"~     The purpose of this study is to assess life satisfaction and long-term outcomes (i.e.,~     medical and psychosocial) of adults who sustained spinal cord injuries (SCI) as children or~     adolescents.~   "
205110|NCT00876824|"~     The purpose of this study is to determine whether a single bolus of dose of Amphoterin B~     lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal~     Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).~   "
205111|NCT00876811|"~     The purpose of this study is determine whether daily consumption of frozen red raspberries~     can improve the antioxidant capacity of the blood and reduce the effects of oxidative stress,~     dose-dependently, in a healthy adult population.~   "
205112|NCT00876798|"~     The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan~     capsules in subjects with Euvolemic Hyponatremia.~   "
205113|NCT00876785|"~     The aim of the present study was to investigate subjective appetite during 8 hours after~     intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content.~   "
205114|NCT00876772|"~     Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by a~     selective degeneration of the motor nerve cells in the cortex and myelon. As a result of~     motor neurodegeneration, a progredient paralysis of the extremities and of the speaking,~     swallowing, and breathing musculature develops. ALS leads to death by respiratory~     insufficiency in a mean course of 3-5 years. More than 80% of ALS patients present with a~     clinically significant and undesirable weight loss. The cause of weight loss is~     heterogeneous. Fundamentally, the investigators must distinguish malnutrition, cachexia and~     loss of appetite. Loss of weight is an independent prognosis factor in ALS. Effective~     treatment of undesirable weight loss is an important therapy goal for ALS.~      The researchers propose an investigational therapy of ALS with oral administration of~     Olanzapine. The rationale for this study is based on the weight-increasing effect of OLN. The~     clinical trial aims to employ OLN-induced weight gain or weight stabilization as a~     symptomatic therapy for the loss of appetite. An undesired weight loss of at least 10% of the~     body weight should be reduced through the weight-increasing effect of OLN. The hypothesis~     states that the undesired weight loss in ALS patients during treatment with OLN 10mg in~     combination with Riluzole (RIL) 100mg is at least 20 percentage points less than for~     treatment with placebo in combination with 100 mg RIL.~   "
205115|NCT00876759|"~     Brain metastases occur in 20-40% of patients with primary extracerebral tumors. Despite~     important advances in therapy of malignant solid tumors and treatment of 1-3 brain~     metastases, multiple brain metastases continue to present a significant problem in attempting~     to prevent progression of disease and limit morbidity associated with therapy. The majority~     of patients who develop brain metastases have a short survival, effective palliation being~     transient. The median survival after diagnosis is as low as 3-6 months. However, there is~     some evidence that selected patients survive prolonged periods with vigorous therapeutic~     approach.~      Specific therapeutic options are surgery, chemotherapy, conventional fractionated whole-brain~     radiotherapy (WBRT) and radiosurgery. Radiosurgery allows delivering of a single high dose~     fraction of radiation to targets of 3-3.5 cm maximum diameter. In patients with newly~     diagnosed brain metastases, a rapid decrease of symptoms, local tumor response rate of 73-90%~     and a median survival of 7-12 month have been reported.~      WBRT alone is the treatment of choice for patients with multiple brain metastases, and for~     patients with single brain metastases not amenable to surgery or radiosurgery. Median~     survival after WBRT alone is 3-6 months.~      WBRT and radiosurgery boost have been shown to improve survival in RPA class I patients and~     in patients with favorable histological status and squamous cell or non-small cell lung~     tumors. All randomized trials showed improved local control with the addition of radiosurgery~     to WBRT (Andrews, 2004).~      WBRT in conjunction with radiosurgery improves local control and reduces the risk of new~     distant brain metastases, but most studies support that combined radiosurgery and WBRT does~     not improve the overall survival expect for patients without evidence of extracranial~     disease.~      Helical Tomotherapy (HT) allows as a sole modality a new treatment option: Using HT, the~     advantage of applying a highly conformal boost dose to the metastases and WBRT can be~     combined in one treatment session. Therefore, it allows applying a high dose to multiple~     brain metastases in the sense of an integrated boost. The focus of this study is to~     investigate the efficacy and safety of WBRT with an integrated boost using this new treatment~     modality in comparison to the effects of conventional WBRT alone.~      The principal objective of the trial is to assess the therapeutic efficacy of WBRT as~     compared to WBRT combined with integrated boost with HT delivered to patients with 2-10 brain~     metastases of solid tumors. The secondary objective is to evaluate the safety of WBRT as~     opposed to WBRT combined with integrated boost as delivered by HT in patients with 2-10 brain~     metastases.~   "
205116|NCT00876746|"~     This research study is to determine if the insertion site of a perineural catheter or tiny~     tube placed next to the nerves that go to the part of the body (hand or arm) having surgery,~     affects the amount of pain relief that is experienced after surgery. Catheters will be placed~     in either the supraclavicular or infraclavicular location.~   "
206483|NCT00858598|"~     This study was designed to observe the outcomes of Pro Osteon according to its cleared~     indications for use.~   "
205123|NCT00876655|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)~     of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium~     phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to~     assess the relative bioavailability of TR-701 free acid phosphate powder in capsule~     formulation compared to di-sodium phosphate salt formulated capsule.~   "
205124|NCT00876642|"~     Radiation therapy (RT) has been a component of breast cancer treatment for almost 100 years.~     Although initially used for the treatment of chest wall recurrences after mastectomy and for~     advanced inoperable disease, RT has evolved into a critical component of early therapy for~     women with an intact breast following lumpectomy and for mastectomized women who are at high~     risk for local failure. Currently breast cancer patients need a multidisciplinary management~     including surgery, chemotherapy and radiotherapy, radiotherapy has a significant role in loco~     regional control of the disease. It is estimated that 87% of these women will develop some~     degree of radiation-induced dermatitis, varying from mild to brisk erythema or even moist~     desquamation.~      Topical agents, such as corticosteroid creams and other products including Aquaphor~     (Beirsdorf Inc, Wilton, CT), and trolamine (Biafine; Genmedix Ltd, France), are commonly~     prescribed at the onset of radiation dermatitis or, in some institutions, at the beginning of~     radiotherapy.~      The aim of this randomized phase III study was to assess the effectiveness of aloe vera cream~     for the prevention of acute radiation-induced dermatitis of grade 2 or higher during~     postoperative radiotherapy for breast cancer, compared to best supportive care. The secondary~     objectives were to assess pain, treatment interruption as a result of skin reactions, and the~     quantity of life during the treatment.~   "
205125|NCT00876629|"~     MR Elastography is a new technique aimed at non-invasively measuring the stiffness of~     tissues. It has recently given interesting results in the assessment of liver fibrosis.~      The objectives of the current study are:~        1. to develop an imaging protocol for MR Elastography of the kidneys;~        2. To calculate the stiffness of normal kidneys;~        3. To evaluate the variability of the measurements of kidney stiffness by repeating the~          procedure twice on the same volunteers.~   "
205126|NCT00876616|"~     The purpose of this study is to assess the efficacy and safety of multi-target therapy in the~     treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ lupus nephritis.~   "
205127|NCT00876603|"~     There is no difference in surgical outcomes for patients suffering from cervical spondylotic~     myelopathy treated with anterior decompression and fusion or posterior cervical laminoplasty.~   "
205128|NCT00876590|"~     According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of~     fingertips as samples to evaluate the accuracy of portable BGM.~   "
205129|NCT00876577|"~     This study is a local, prospective, open-label, company-sponsored, non interventional,~     multi-center study. Patients documented must suffer from an acute exacerbation of chronic~     bronchitis and take at least one dose of Moxifloxacin injection.The primary objective is to~     obtain clinical effectiveness and safety data of Moxifloxacin injection in the treatment of~     acute exacerbations of chronic bronchitis in patients in whom Moxifloxacin was routinely~     prescribed. The secondary objective is to find out the possible correlation between the risk~     factors (sex, smoking, number of previous exacerbations, etc) and AECB, the different~     treatment effectiveness according to Anthonisen classification. This study will also collect~     the data of pathogens by sputum culture and the defervescence time of Moxifloxacin injection~     in treating Acute Exacerbations of Chronic Bronchitis (AECB).~   "
205130|NCT00876564|"~     The purpose of this study is to improve performance, Stavanger University Hospital (SUH)~     reorganized key system structures and introduced in 2009 mandatory documentation of field~     Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for~     field triage. Through a before and after study, the investigators aim to measure how the~     quality improvement initiative will influence structure, process and outcomes variables.~   "
205131|NCT00876551|"~     The purpose of this study is to determine the short and long term outcome of endoscopic~     vacuum assisted closure of intrathoracic postsurgical leaks.~   "
205132|NCT00876538|"~     The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores~     after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia~     scores.~   "
205133|NCT00876525|"~     This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve~     when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.~   "
205134|NCT00876512|"~     Dual antiplatelet therapy with aspirin and thienopyridines decreases the rate of stent~     thrombosis in patients undergoing percutaneous coronary intervention (PCI). However, despite~     intensified antiplatelet treatment, some of the patients undergoing PCI develop thrombotic~     stent occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance.~     The present study is designed in order to clarify the influence of CYP2C19 genetic~     polymorphism on the several biomarkers for platelet activation in Japanese patients treated~     with thienopyridines undergoing elective PCI.~   "
205135|NCT00876499|"~     This goal of this research study is to learn more about fatigue, sleep quality, and other~     symptoms in patients with primary brain tumors who are being treated with radiation therapy.~      Objectives:~      PRIMARY OBJECTIVE:~      1. The primary objective of this study is to provide preliminary data describing the severity~     and change over time in fatigue using the Brief Fatigue Inventory (BFI) during radiation~     therapy for patients with primary gliomas.~      SECONDARY OBJECTIVES:~        1. To evaluate longitudinal changes in the severity of symptoms and the mean symptom burden~          as measured by the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) and~          mood using the Profile of Mood States (POMS) during radiation therapy.~        2. To assess alterations in circadian rhythms using actigraphy during radiation therapy and~          the association with sleep quality tools - Pittsburgh Sleep Quality Index (PSQI) and the~          Epworth Sleepiness Scale(ESS), and the severity of BFI and MDASI-BT scores over time.~        3. To explore the association between the levels of salivary hormones (melatonin and~          cortisol) and the occurrence of fatigue and symptom burden.~   "
205136|NCT00876486|"~     Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in~     subjects with recurrent or metastatic breast cancer.~   "
205137|NCT00876473|"~     The aim of this study is to evaluate the performance, the tolerability and the efficacy on~     gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems.~   "
205138|NCT00876460|"~     To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas~     recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60~     mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with~     stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the~     recommended dose for the Phase II trial.~   "
205139|NCT00876447|"~     The purpose of this study is to assess the long-term safety and effectiveness of botulinum~     toxin type A on patients with overactive bladder as a result of spinal cord injury or~     multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376~     and NCT00461292).~   "
205140|NCT00876434|"~     Background:~        -  Uveitis is an inflammatory condition in which the patient's own immune system attacks~          the eye, causing eye inflammation and vision loss. Patients with uveitis may be treated~          with immunosuppressive medications to reduce the inflammation and prevent vision loss.~        -  Sirolimus is an immunosuppressive medication that is approved by the U.S. Food and Drug~          Administration (FDA) to prevent organ rejection following a kidney transplant.~          Researchers think that sirolimus may affect the part of the immune system that may be an~          important cause of uveitis, and may decrease the inflammation that causes uveitis.~        -  In this study, sirolimus will be given as an injection under the outer layer of your~          eye. The FDA has permitted the investigational use of sirolimus for this study.~      Objectives:~        -  To determine if subconjunctival injection of sirolimus is safe for treatment of uveitis.~        -  To see if sirolimus is an effective treatment for uveitis.~      Eligibility:~        -  Patients 18 years of age and older with active uveitis in one or both eyes. If a patient~          has uveitis in both eyes, the one in which the inflammation is worse will be treated~          during the study. The vision in the study eye must be at least 20/400.~        -  Patients must have good liver function, and must be willing to practice sun protection~          measures for 2 weeks following the treatment.~      Design:~        -  Treatment with sirolimus in the study eye:~        -  Antibiotic and numbing eye drops will be given before the sirolimus injection.~        -  1 dose of sirolimus will be injected directly into the subconjunctiva (white part of the~          eye).~        -  Antibiotic drops will be given for topical application 3 times per day for 2 days after~          the injection.~        -  Patients will be followed for 16 weeks after sirolimus injection (initial visit and~          follow-up visits in Weeks 2, 4, 8, 12, and 16).~        -  Evaluations during the treatment period and follow-up visits:~        -  Physical examination, including vital signs and body weight checks, and pregnancy test~          for women who can become pregnant.~        -  Full medical and ophthalmic history, involving questionnaires and discussion with~          researchers.~        -  Eye examination, dilation, and photography, including measurements of retinal thickness~          and fluorescent dye tests of blood flow in the eye.~        -  Blood and urine tests.~        -  Because of the increased risk of skin cancer associated with sirolimus, patients ...~   "
205141|NCT00876421|"~     The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539~     in patients with overactive bladder.~   "
205142|NCT00876408|"~     This will be a retrospective review of 30 patients with unknown primary cancer who have had~     commercially available RT-PCR assays performed on biopsied tumors, in order to determine if~     the assay results are consistent with clinical features and useful for planning initial~     therapy or changing therapy.~   "
205143|NCT00876395|"~     The purpose of this Phase III study is to confirm the value of adding everolimus to weekly~     paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.~   "
205144|NCT00876382|"~     A retrospective medical record abstraction study of at least 200 advanced renal cell~     carcinoma patients treated in the following settings:~        -  Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as~          second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line~          therapy (about 100 patients)~        -  Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as~          first-line therapy followed by Sunitinib (Sutent) as second-line therapy (about 100~          patients)~   "
205145|NCT00876369|"~     The objective of this study is to perform an exploratory analysis to determine if a possible~     relationship between vitamin D and chronic urticaria and/or angioedema exists. The study~     hypothesis is that vitamin D deficiency is associated with chronic urticaria and/or~     angioedema.~   "
205146|NCT00876356|"~     Conjugated linoleic acids (CLA) are naturally occurring free fatty acids derived from the~     tissues and milk of ruminant animals such as cows. CLA has multiple biological properties~     including regulation of metabolism and immune processes, including tissue inflammation.~     Asthma symptoms are caused by irritation and inflammation of the airways. Our hypothesis was~     that CLA may reduce airway inflammation in asthma and thus reduce asthma symptoms. The aim of~     this pilot study was to investigate the efficacy and safety of CLA as a dietary supplement in~     mild asthma. Subjects will be assigned to take CLA dietary supplements or placebo (olive oil)~     for 12 weeks in addition to their usual asthma treatment. They will be monitored for asthma~     symptoms, side effects, lung function and blood markers of inflammation.~   "
205147|NCT00876343|"~     To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy~     co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a~     serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive~     disorder.~   "
205148|NCT00876330|"~     The purpose of this study is to evaluate the impact of electronic health record clinical~     decision support and automated telephone outreach on antihypertensive and lipid-lowering~     therapy in ambulatory care.~   "
205149|NCT00876317|"~     The purpose of this study is to evaluate the efficacy and safety two oral doses of etoricoxib~     (60 mg and 90 mg) daily in acute soft tissue rheumatism affecting the shoulder.~   "
205150|NCT00876304|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.~   "
205151|NCT00876291|"~     Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria~     and maintaining the integrity of the gut mucosal barrier. The beneficial effects of~     probiotics have been previously studied in adult patients with IBS. Even though most of the~     studies demonstrate efficacy, other studies do not support these observations. Few studies~     addresses the efficacy of probiotics in children with IBS. The goal of the present study was~     to determine whether oral administration of the probiotic Lactobacillus GG under randomized,~     double-blind, placebo-controlled conditions would improve symptoms of children with abdominal~     pain.~   "
205152|NCT00876278|"~     Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of~     pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL *AT.Smart~     46LC.~      Target Criterion:~      Measurement of contrast sensitivity and sensitivity to light under mesopic conditions~     (Mesotest II, Oculus).~   "
205153|NCT00876265|"~     This was a study to find out how an investigational product, Belotero, compares to a second~     product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are~     wrinkles on the face that go from the outside of the nostrils to the edges of the mouth.~     Additionally, this study determined Belotero is safe and tolerable and corrects facial~     wrinkles, such as nasolabial folds.~   "
207068|NCT00850889|"~     Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with~     Restylane in the correction of nasolabial folds.~   "
205154|NCT00876252|"~     Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study~     (approximately 50 centers) in approximately 9 countries. Proposed start date is December~     2008. The study duration per patient is estimated to be 90 days. Overall study duration is~     estimated to be 12-18 months.~   "
205155|NCT00876226|"~     This prospective study will determine the pharmacokinetic parameters of citalopram in 12~     adult patients with short bowel syndrome. While data on the prevalence of depression in~     patients with short bowel syndrome is sparse, the investigators' experience is that these~     patients have a high incidence of depression and should benefit from a psychopharmacological~     intervention.~   "
205156|NCT00876213|"~     The aim of this proposal is to dissect the mechanisms controlling gastric emptying, appetite~     and food intake in humans, and to obtain new knowledge to fight obesity on a pharmacological~     basis.~   "
205157|NCT00876200|"~     The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a~     multisystem developmental impairment. This syndrome is caused by a microdeletion in~     chromosome 7q11.23 that encompasses loss of the elastin locus.~      Elastin, which is part of the extracellular matrix, controls proliferation of vascular smooth~     muscle cells (VSMCs) and stabilizes arterial structure. Loss of elastin gene in WBS patients~     has been claimed to provide a biological basis for the abnormal elastic fibre properties~     leading to cardiovascular abnormalities like supravalvular aortic stenosis (SVAS),~     hypertension, arteriosclerosis and stenosis in more than 50% of WBS children.~      These cardiovascular pathologies result in important consequences and neither curative nor~     preventive medicinal treatments exist at this time. Surgery is needed in more than half~     cases, while it is often leading to complications.~      Minoxidil is a well-known antihypertensive drug used in adults and children. Furthermore,~     according to animal studies, minoxidil seems to increase arterial elastin content by~     decreasing elastase activity in these tissues. Other data demonstrate that minoxidil~     specifically stimulate elastin synthesis.~      Working Hypothesis:If insufficient elastin synthesis leads to vascular complications and~     arterial hypertension in children with WBS, restoration of sufficient quantity of elastin~     should then result in prevention or inhibition of vascular malformations and improvement in~     arterial tension. Therefore, as a pharmacological agent capable to stimulate elastin~     expression, minoxidil might be a useful drug for the treatment of abnormal elastin metabolism~     in WBS children.~      Objective:To evaluate the efficacy of minoxidil on cardiovascular structure in children with~     Williams Beuren syndrome.~      Methodology: randomized controlled trial on two parallel group (23 patients in each arm) Main~     criterion:variation of carotid Intima-media thickness (IMT) before and after 12 months of~     treatment with Minoxidil versus placebo Secondary intermediate criteria of the vascular~     properties are arterial stiffness, cardiac and renal stenosis, arterial tension.~      Total study duration:30 months including a 12 month-recruitment period~   "
205158|NCT00876187|"~     The purpose of this study is to evaluate the efficacy and safety of multiple doses of~     tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a~     monoclonal antibody directed against human nerve growth factor.~   "
205159|NCT00876174|"~     The objective of this pilot project is to investigate the prognostic criteria for sensitivity~     of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in~     peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC~     patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to~     undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV~     subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC~     subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following~     the completion of treatment.~   "
205160|NCT00876161|"~     This study will evaluate the safety, tolerability, and systemic exposure of an experimental~     influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is~     administered via oral inhalation using a special device. Study participants will include~     healthy non-smoking males and females, ages 18-65. They will be given either DAS181 or~     placebo. Participants will remain in the clinic overnight to be watched for health changes~     for 24 hours after receiving the medication. Study procedures include: physical exams, chest~     x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs.~     Follow-up visits will occur on study days 2, 7, 14 and 30.~   "
205161|NCT00876148|"~     The purpose of this study is to evaluate the risk of hepatitis B reactivation in patients~     undergoing allografting.~   "
205162|NCT00876135|"~     The prevalence of airway hyperresponsiveness (AHR) is very high in elite swimmers, reaching~     80% in certain studies. Repeated Chlorine-derivatives exposure may be a major causative~     factor for its development. Asthma diagnosis is generally made on the basis of clinical~     characteristics. The demonstration of a variable bronchial obstruction through positive~     expiratory flow reversibility to a bronchodilator, spontaneous variations of airway~     obstruction or a positive provocation test (methacholine, eucapnic voluntary hyperpnoea…) is~     necessary to avoid false diagnosis. Currently asthma treatment in swimmers is the same as in~     the general population. A short-acting bronchodilator is often prescribed to avoid occasional~     symptoms, combined with an inhaled corticosteroid or an antagonist of Leukotriene if asthma~     symptoms are persistent. Previous studies have shown a reduced efficiency for asthma~     medication in elite athletes compared with non-athletes. The specific response to different~     medications remains to be studied in athletes. The effects of a short-acting bronchodilator~     in swimmers with AHR, especially when asymptomatic, on pulmonary function and performance~     have not yet been studied. Moreover, the significance of a positive bronchial provocation~     test remains to be studied in asymptomatic swimmers with AHR.~   "
205163|NCT00876122|"~     This is an open-label, Phase I, dose-escalation study using a 3 + 3 design to assess the~     safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD.~     This study will include patients with locally advanced or metastatic solid tumors, NHL, or~     multiple myeloma (MM) (expansion stage only) for which standard therapy either does not exist~     or has proven ineffective or intolerable.~   "
205164|NCT00876109|"~     This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics of orally administered GDC-0941 administered once daily~     (QD) and twice daily (BID) in the treatment of advanced or metastatic solid tumors.~   "
205180|NCT00875901|"~     This is a research study to determine if hypofractionated image guided radiation therapy~     (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients~     who will not have surgery. HypoIGRT delivers higher daily doses of radiation over a shorter~     period of time compared with conventional radiation. This is thought to deliver a more lethal~     dose of radiation to the tumor and is more convenient with treatment being completed within~     2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.~   "
205344|NCT00873743|"~     The aim of this study is to evaluate quality of patient-controlled peroral analgesia after~     cesarian section using the combination of tramadol and acetaminophen. Research hypothesis is~     that the combination reduces pain at leg rising more than tramadol alone.~   "
205165|NCT00876096|"~     Invasive fungal infections have a major impact on the morbidity and mortality of~     immunocompromised patients, including patients with hematological malignancies, neutropenic~     patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted~     patients and patients admitted in an intensive care unit.~      The survival of these patients depends on early diagnosis and prompt appropriate antifungal~     treatment. The early diagnosis of these infections is difficult because of the lack of~     sensitive test methods, notably blood cultures. For these reasons, the investigators decided~     to develop a real-time PCR (Polymerase Chain Reaction) assay on blood samples. It should~     allow rapid response to establish a positive or negative diagnosis of invasive fungal~     infection, could contribute strongly to the decision of treating using antifungals, and~     should monitor the effectiveness and the optimization of antifungal prescriptions.~      The investigators' objectives are: First, to validate an extraction method from blood~     infected by fungi species. Secondly, the investigators want to develop three real-time PCR: A~     fungal real-time PCR able to detect most fungal species; a real-time PCR targetting Candida~     albicans and Aspergillus fumigatus which are two clinically important pathogens. Then blood~     samples of patients (classified according to EORTC consensus) will be collected during the~     study in order to evaluate and validate our method on clinical samples. Results will allow~     the investigators to determine the sensitivity, specificity and reproducibility, negative and~     predictive values.~      Overall, the investigators' work aims to evaluate the clinical impact of real-time PCR in the~     early diagnosis of invasive fungal infections and on the initiation or stopping of antifungal~     therapy. The economic impact resulting from the use of this method will be evaluated.~   "
205166|NCT00876083|"~     The purpose of this study is to obtain data on the safety and efficacy of Ultravist~     application in usual daily use.The radiologist will administer the contrast medium to the~     patient as he/she would have done without the study. No other examinations will be performed~     than would have been done routinely.~   "
205167|NCT00876070|"~     This is a retrospective medical record abstraction study. It is a review and evaluation of up~     to 300 metastatic breast cancer patients treated with Abraxane or other taxanes such as~     paclitaxel and docetaxel to determine the overall cost of care for Abraxane compared to other~     taxanes in the first-line metastatic cancer setting and the cost of care for Abraxane~     compared to other taxanes when broken down by individual components of cost. In addition, the~     investigators will review the following patient outcomes: response rate, duration of therapy,~     toxicity, and survival.~   "
205168|NCT00876057|"~     The purpose of this study is to determine whether psychological well-being, recovery and~     sexuality differs in women undergoing subtotal and total abdominal hysterectomy.~      Se also Detailed Description for additional study.~   "
205169|NCT00876044|"~     The primary objective of this study is to evaluate the effects of aflibercept on the QTc~     interval in cancer patients.~      Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram~     (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.~   "
205170|NCT00876031|"~     The purpose of this study is to investigate whether the addition of oral maintenance~     chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event~     free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue~     Sarcoma.~   "
205171|NCT00876018|"~     The purpose of this study is to evaluate the effect of nutritional supplement on physical~     performance measures of apparently healthy school going children in India.~   "
205172|NCT00876005|"~     This is a study to see whether increasing the oxygen concentration during and after a~     cesarean section decreases the infection rate.~   "
205173|NCT00875992|"~     In many cases, the existing locking bolts and screws in intramedullary nails do not provide~     sufficient stability. The play between screw and nail can result in loss of reduction and the~     instability due to the interfragmentary movement can result in malunions or nonunions.~     Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to~     enhance axial and angular fracture stability. ASLS provides angular-stable fixation between~     nails and screws with resorbable sleeves used as dowels in the nail locking holes.~     Preliminary results of a pre-study show a trend towards reduced time to pain-free full weight~     bearing in patients being treated with ASLS. This hypothesis will be tested in the present~     randomized controlled study.~   "
205174|NCT00875979|"~     This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study~     designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab~     emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with~     pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally~     advanced or metastatic breast cancer who had previously received trastuzumab.~   "
205175|NCT00875966|"~     The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral~     suspension.~   "
205176|NCT00875953|"~     Neck dissection is the main technique used by head and neck surgeons to treat known or~     suspected metastatic cancer to the neck. The traditional radical neck dissection was~     effective at treating metastatic cancer to the neck however the downside to this technique~     was significant morbidity. Since the early 1960's there has been several proposed techniques~     to treat metastatic head and neck cancer that involves preserving important anatomical~     structures in the neck. The disadvantage to these techniques are that they require meticulous~     dissection and can lead to bleeding and an increase in operative time. One particular tool~     that has been proposed in other surgical subspecialties, including head and neck surgery, is~     the harmonic scalpel. Using this tool, tissue dissection and vessel occlusion at the same~     time can occur with a reduced thermal damage to the surrounding tissue when compared to~     traditional cautery. In this study, our purpose is to determine if the harmonic scalpel will~     lead to a decrease in blood loss and operative time in patients undergoing a modified radical~     neck dissection compared to electrocautery.~      Hypothesis: Use of the harmonic scalpel as a surgical adjunct will reduce operative time for~     neck dissection and will reduce intraoperative blood loss.~   "
205177|NCT00875940|"~     The study hypothesis is that a quantitative index can be derived from Tc-99m myocardial~     perfusion scans that accurately identifies the presence of left ventricular hypertrophy and~     pulmonary hypertension. Echocardiography provides the reference standard.~   "
205178|NCT00875927|"~     Users of Breezy candy will utilize the candy's abrasiveness to scrape tongue surface. The~     scraping action together with the release of compounds contained inside the abrasive~     microcapsules will result in significant reduction of oral halitosis.~   "
205179|NCT00875914|"~     The MAGMA-AVNRT study compares two different methods of handling the ablation catheters for~     av-node-reentry-tachycardia with regard to x-ray dose, safety and success: manually guided vs~     magnetically navigated RF-catheter.~   "
205195|NCT00875706|"~     This study aimed to explore the feasibility of an educational intervention to strengthen~     workplace learning systems in four VA Community Living Centers (CLCs).~   "
205181|NCT00875888|"~     This study will assess the influence of the High Cut-Off (HCO) CVVHD treatment on the disease~     progression in septic patients. The primary aim of the study is to evaluate whether HCO CVVHD~     leads to a significant improvement of the hemodynamic status (mean arterial pressure,~     vasopressor requirements) in septic patients in comparison to CVVHD treatment with~     conventional high-flux filters. For the HCO-group the investigators expect a 50% lower dosage~     of vasopressors needed to maintain an adequate organ perfusion.~   "
205182|NCT00875875|"~     The study will compare durations of diarrhea among subjects who report to clinic for~     treatment and who receive either:~        1. standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR~        2. a single 600 mg dose of rifaximin daily for 3 days.~   "
205183|NCT00875862|"~     Research study to determine if putting local anesthetic through a tiny tube next to the~     nerves that go to the shoulder will improve shoulder range-of-motion following the shoulder~     procedure performed on the frozen shoulder. It will also help determine if patients have a~     higher quality-of-life and less pain, require fewer pain pills, experience fewer sleep~     disturbances, and are more satisfied with their post-procedure pain control.~   "
205184|NCT00875849|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. Giving chemotherapy together with radiation therapy and cetuximab may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation~     therapy and cetuximab works in treating patients with head and neck cancer.~   "
205185|NCT00875836|"~     Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated~     pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of~     buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management~     (CM) intervention and motivational enhancement therapy (MET) will be incorporated to~     encourage study engagement and retention. It is hypothesized that buspirone combined with MET~     and CM will reduce the percent of marijuana-positive urine drug screen results in~     marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.~   "
205186|NCT00875823|"~     The purpose of this study is to collect medical information from a large number of patients~     in many areas of the world with primary hyperoxaluria. This medical information will be~     entered into a registry to help the investigators compare similarities and differences in~     patients and their symptoms. The more patients that the investigators are able to enter into~     the registry, the more the investigators will be able to understand primary hyperoxaluria and~     learn better ways of treating patients with this disease. It is the investigators hope that~     by entering as many patients with PH as possible, the information that the investigators~     collect may help physicians diagnose patients sooner and determine what treatments may work~     best on patients with similar medical or genetic backgrounds.~   "
205187|NCT00875810|"~     Prestige artificial disc replacement is an alternative treatment option with 16 years of~     experience addressing the unmet needs of surgical fusion interventions. Previous studies on~     the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc~     surgery with level I evidence.~      The PRESTIGE Observational Study is intended to collect prospectively observational data~     primarily on the Quality of Life (QoL).~   "
205188|NCT00875797|"~     Glutamine is a major fuel for the intestinal tract and immune cells and therefore affects the~     intestinal permeability (IP) and infection rate at critically ill patients. The preferential~     route of glutamine supplementation at critically ill patients still remains open. Therefore~     the researchers will investigate IP, infection rate and treatment outcome at patients~     supplemented with either parenteral or enteral glutamine.~      A prospective randomized single blind study is performed at mechanically ventilated. Patients~     were randomly assigned to either parenteral (group P) or enteral (group E) glutamine~     supplemented group. Early enteral feeding is started in both groups. Patients are/will be~     treated with glutamine for five days. IP will be measured using lactulose/mannitol test (L/M)~     on the fourth day.~   "
205189|NCT00875784|"~     This study will evaluate the exposure of sumatriptan after administration of TREXIMA~     (sumatriptan 85mg/naproxen sodium 500mg) followed by a subcutaneous IMITREX injection (4mg or~     6mg) 2 hours later compared to administration of a IMITREX 100mg tablet followed by a IMITREX~     100mg tablet 2 hours later.~   "
205190|NCT00875771|"~     The purpose of this study is to determine efficacy and safety of the biweekly scheme with~     Capecitabine and Irinotecan, plus bevacizumab in patients with metastatic colorectal cancer.~   "
205191|NCT00875758|"~     Intraventricular hemorrhage remains the most frequent, severe neurological complication of~     prematurity, occurring in 25-30% of preterm infants. Post-hemorrhagic ventricular dilation~     (PHVD) occurs in 25-50% of those infants, with over half requiring ventriculoperitoneal~     shunts. When suboptimally untreated, PVHD results in a 3-4 fold increase in~     neurodevelopmental delay. Despite the lifelong impact of PHVD on quality of life, little~     research has been done over the past 20 years to improve patient outcomes.~      The CENTRAL HYPOTHESIS of this project is that early treatment of PHVD will reduce~     shunt-dependence and improve neurodevelopmental outcome in preterm infants.~   "
205192|NCT00875745|"~     The purpose of this study is to test the safety of sorafenib and vorinostat when given~     together to see what effects (good and bad) it has on the patient and their acute myeloid~     leukemia (AML) or myelodysplastic syndrome (MDS). This study is also being done to find the~     highest dose of sorafenib and vorinostat that can be given together without causing severe~     side effects.~   "
205193|NCT00875732|"~     The aim of the study is to see if biventricular pacemakers offer any advantage over~     conventional pacemakers in patients with heart failure who require pacemakers. The endpoints~     will be the 6 minute walking distance along with markers of cardiovascular function.~      The investigators' hypothesis is that biventricular pacing is preferable to conventional~     pacing in these heart failure patients.~   "
205194|NCT00875719|"~     The purpose of this study is to compare differences in oxygen delivery between portable~     oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs~     are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized,~     single-blind clinical trial.~   "
205196|NCT00875693|"~     This open-label Phase I study is designed to determine the maximum tolerated dose (MTD) for~     CPX-351 followed by a reduced intensity conditioning regimen and incorporates a~     dose-escalation schedule that sequentially enrolls 6 dosing cohorts. After the determination~     of the MTD, the investigator reserves the option to enroll up to 10 additional subjects in an~     expanded safety cohort(s) at the MTD.~      Refractory and relapsed AML patients who meet standard institutional criteria to undergo~     sequential induction/reduced intensity conditioning allogeneic transplants will be offered a~     transplant from a related or unrelated donor (full match or 1 antigen mismatch). Cord blood~     transplants will not be used in this study.~   "
205197|NCT00875680|"~     Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime~     sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events.~     The most effective treatment consists in ventilation by mask with continuous positive airway~     pressure (CPAP), that prevents collapse of the upper airway. However the degree of~     collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or~     sedative consumption. Thus, CPAP treatment (invented in 1981) has evolved with the~     development of more sophisticated equipment that permits adapted variations in pressure~     levels (autoCPAP) with the objective adjusted pressure to avoid airways obstruction with~     minimal pressure.~      Different models of autoCPAP function with different signals and event detection algorithms~     with different modes of reaction to events. These machines are marketed with CE~     certification, that guarantees electrical security, but there is to date, no requirement for~     pre-marketing clinical validation. Nonetheless inadequate treatment may leave patients at~     risk of accidents and cardiovascular events. These machines can be bench tested using test~     equipment that can measure with accuracy the response to simulated events, but the testing~     equipment cannot simulate the diversity of clinical situations, nor the residual level of~     microarousals that may persist. Thus these bench tests need to be supplemented by clinical~     studies. The investigators objective is to test the efficacy of these machines on residual~     sleep-related events during a one night autotitration polysomnography. We develop a~     prospective, multicentre, non randomised study with autotitration polysomnography only for~     one night. These clinical results will be compared with the results of bench tests in order~     to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical~     evaluation. The perspective of developing a reliable testing protocol may eventually play a~     role in the certification of these machines.~   "
205198|NCT00875667|"~     To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients~     with relapsed or refractory Mantle Cell Lymphoma.~   "
205199|NCT00875654|"~     The main objective of the study is to evaluate feasibility and tolerance of the intravenous~     injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke~     (less than 6 weeks).~   "
205200|NCT00875641|"~     This observational cohort study, conducted through two existing large administrative health~     databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety~     profile regarding lack of any association of intussusception with Rotarix within 60 days of~     vaccination in a real life setting (routine use) in the US. This study will also include~     monitoring of Kawasaki disease, convulsions, hospitalizations due to acute lower respiratory~     tract infections and all-cause deaths within 60-days of vaccination.~      This study involves three cohorts, one exposed and two control cohorts: infants who receive~     Rotarix (Exposed cohort) and infants who receive IPV vaccination (Unexposed cohort A and B).~      This is a combined prospective and retrospective cohort study. Prospective component of the~     study identifies and compares study outcomes following Rotarix and IPV vaccination in the~     Exposed cohort and Unexposed cohort A, respectively.~      Retrospective component of the study identifies and compares study outcomes following IPV~     vaccination in the Unexposed cohort B.~   "
205201|NCT00875628|"~     Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple~     oral administrations of PF-00868554 in Japanese healthy adult volunteers.~   "
205202|NCT00875615|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. Infusing chemotherapy directly into~     the liver and giving it together with sorafenib may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or~     carboplatin directly into the liver and giving it together with sorafenib in treating~     patients with liver cancer that cannot be removed by surgery.~   "
205203|NCT00875602|"~     Evaluation of continuous monitoring device on patients Risk during hospitalization and nurse~     satisfaction level.~   "
205204|NCT00875589|"~     The study investigates whether the use of eye movement recordings can provide a reliable~     diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in~     Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.~   "
205205|NCT00875576|"~     The objective of this study is to directly compare the effects of parents and friends on~     overweight and non-overweight children and adolescents' food intake and food selection using~     a cross-sectional design. Overweight and non-overweight children (5-6 year-old) and~     adolescents (13-14 year-old) will share a meal with a friend and with a parent on separate~     occasions. Participants' food selection and the amount of food they consumed will be compared~     across conditions.~      Hypothesis 1: The investigators hypothesize that overweight children and adolescents will~     select more unhealthy food items and eat more in the presence of an overweight friend than~     when eating with a lean friend; whereas lean participants eating with an overweight friend~     will eat a similar amount of food than lean youth eating with a lean friend.~      Hypothesis 2: The investigators predict that overweight children and adolescents (but not~     lean children and teens) will consume more food in the presence of their mother than in the~     presence of a friend.~      Hypothesis 3: The investigators also predict that overweight youth's energy intake will be~     related to parental prompts.~      Hypothesis 4: The investigators expect greater similarities in terms of food selection and~     food intake between adolescents and their friend than between adolescents and their parent.~   "
205206|NCT00875563|"~     The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation~     approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA~     Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.~   "
205207|NCT00875550|"~     The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in~     intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects. The key~     study objectives are:~        -  To characterize the loading and maintenance dosing of DEX by age group and overall~          medical condition of pediatric subjects~        -  To evaluate the safety and efficacy of loading and maintenance infusions for sedation in~          initially intubated and mechanically ventilated PICU subjects~        -  To explore the exposure-response relationship between dose of DEX and clinical measures~          of sedation and safety~   "
205208|NCT00875537|"~     Burning mouth syndrome (BMS) is characterized by a bilateral burning sensation in the~     anterior tongue, hard palate and lips in the absence of any clinical or laboratory findings.~     The term syndrome implicates the simultaneous presence of oral dryness (xerostomia) and~     altered taste (dysgeusia) in addition to the burning sensation in the oral mucosa. BMS is~     most often seen in women and is more frequent during menopause. The etiology and pathogenesis~     are still unclear but recent studies suggest that BMS is a neuropathic pain condition.~      The objectives of the study are:~        -  To clarify potential neurogenic mechanisms behind BMS using immunohistochemistry (IH) to~          characterize the localization and distribution of peripheral nerve fibres, neuropeptides~          like substance P, calcitonin gene-related peptide, nerve growth factor, nerve growth~          factor receptor, PGP 9.5 neuronal marker and TRPV1 as well as inflammatory/structural~          changes.~        -  To perform a randomized double blind cross-over intervention study to examine the~          efficacy and safety of topical application of capsaicin oral gel (on the tongue) to~          relieve the burning sensation in patients with BMS.~   "
205209|NCT00875524|"~     This trial will evaluate the use of a tetravalent vaccine against dengue.~      Primary objectives:~        -  To describe the immune response to dengue before and after each vaccination with~          tetravalent dengue vaccine in adults, adolescents, and children.~        -  To evaluate the safety of each vaccination with sanofi pasteur's tetravalent dengue~          vaccine in 4 age cohorts.~        -  To evaluate the persistence of antibodies against dengue during 5 years after the first~          vaccination with sanofi pasteur's tetravalent dengue vaccine in the four age cohorts.~   "
205210|NCT00875511|"~     The study seeks to discover whether peer rejection increases the value of food relative to~     peer interaction in overweight individuals. After playing a computer game that randomly~     simulates peer rejection or peer acceptance, participants will play another computer game~     that will assess the value of food and social interactions.~      Overweight individuals may be more likely to resort to food in moments of distress and less~     likely to choose to interact with a peer to reestablish their sense of belongingness.~   "
205211|NCT00875498|"~     The purpose of this study is to determine whether the iTBS is an effective treatment of the~     negative symptoms of schizophrenia.~   "
205212|NCT00875485|"~     This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B~     surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary~     vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix~     Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited~     for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the~     persistence of immune response. For subjects detected with decreased immunity, the presence~     of immune memory against hepatitis A & B antigens will be investigated by the administration~     of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up~     time-point.~      No new subjects will be recruited during this booster phase of the study.~   "
205213|NCT00875472|"~     The purpose of this study is to assess the effects of peer influences on snack purchases in~     adolescents. During the session teens will be given a certain amount of money to use to~     purchase foods and beverages in a hypothetical convenience store setting.~      The investigators hypothesize that overweight youth will be less responsive to own-price~     elasticity for high calorie foods and less likely to show cross price elasticity for low~     calorie foods when the price of the high calorie for nutrient foods increases. The~     investigators also predict that overweight youth will show more cross price elasticity for~     low calorie foods when in the presence of peers; whereas lean youth's food purchases and~     price sensitivity will not be affected by the presence of peers.~   "
205214|NCT00875459|"~     Follow-on study to the VIAject™ 06J study to evaluate the long-term safety and efficacy of~     VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 1~     diabetes mellitus.~      The VIAject™ 06J study is the efficacy and safety study for insulin VIAject™ to demonstrate~     equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin and~     regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for~     VIAject™ in comparison to human insulin~   "
205215|NCT00875446|"~     The drug being tested in this study is GSK1223249. It is being developed by GlaxoSmithKline~     to treat symptoms in patients with Amyotrophic Lateral Sclerosis (ALS).~      The drug works by inhibiting the protein that prevents nerve growth.~      This will be the first time the drug will be given to man. The trial is expected to involve~     approximately 76 patients. The study objective is to investigate the tolerability, safety and~     the way the body handles GSK1223249 after a range of single doses or repeat dose escalation~     in patients with ALS.~   "
205216|NCT00875433|"~     A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the~     effectiveness of afatinib (BIBW 2992) in treating certain cancers. Cancers studied will~     include glioblastoma and cancers which have spread to the brain (metastases).~   "
205217|NCT00875420|"~     The purpose of this study is to determine whether RAD1901 is effective in decreasing hot~     flashes in postmenopausal women.~   "
205218|NCT00875407|"~     Context. Nuclear imaging plays a central role in management of chromaffin-tissue derived~     tumors because tumor cells exhibit peptide receptors and proteins involved in metabolism that~     can be targeted with specific radiopharmaceutics. Recently, over expression dopamine-receptor~     D2 isoforms has been found in endocrine tumors.~      Objective. The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2~     agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will~     be also compared to traditional SPECT imaging procedures.~   "
205219|NCT00875394|"~     After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once~     daily added to the regimen of patients with inadequate glycemic control on metformin~     monotherapy~   "
205220|NCT00875381|"~     The purpose of this study is to estimate and define the mean number, degree of confluence,~     and depth of penetration of melanocytes in chronically sun exposed skin of the head and neck~     using Mart-1 immunostains on frozen sections. The study was conducted to confirm whether~     similar results were found using permanent sections. The present study used hematoxaline and~     eosin (H&E) staining as well as Mart-1 staining, and included patients from both Mayo Clinic~     Jacksonville and Rochester.~   "
207566|NCT00844259|"~     The aim of this study was to verify the use of communicative functions by children with DS in~     two interaction conditions: interaction with therapist and interaction with parent.~   "
205221|NCT00875368|"~     Rationale: Improving cellular immunity by means of increasing CD4 cells is one of the goals~     of antiretroviral therapy in HIV, which is achieved by means of virological suppression. A~     certain group of patients, the so called immunologic non responders, fail to reach an~     acceptable CD4 cell increase despite an adequate virologic response on antiretroviral~     treatment. Recently a new antiretroviral agent, maraviroc (Celsentry®), is registered for the~     treatment of patients infected with CCR5 tropic HIV-1 virus. However, data is available~     suggesting that treatment with maraviroc leads to immune recovery (increase in CD4 cells) in~     patients who are infected with dual/mixed tropic HIV-1 virus, in the absence of a virologic~     response. This suggests an alternative mechanism for immune recovery, which could be~     especially beneficial for this group of patients.~      Hypothesis: Maraviroc, by a yet unknown mechanism, stimulates immune recovery by increasing~     CD4+ cell count.~      Objective: The primary objective is to confirm the hypothesis that maraviroc stimulates~     immune recovery; the secondary objective is to explore, by virologic and immunologic~     investigations, the underlying mechanisms of this hypothesis.~      Study design: multicentre, randomized, placebo-controlled, double blind, exploratory~     mechanistic study.~      Study population: HIV-1 infected patients 18 years or older, who meet the inclusion criteria.~      Intervention: One group receives maraviroc (dose dependent on co-medication), the other group~     placebo.~      Main study parameters/endpoints: A 30% increase in CD4 cell rise in the treatment group~     (compared with placebo).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~        1. In the treatment group subjects will start with a registered antiretroviral agent~          (maraviroc).~        2. During the treatment year patients will perform several study visits, probably three~          more compared with regular visits on the outpatient clinic.~        3. Each visit, blood will be drawn by venepuncture for immunologic and virologic~          investigations (see flow chart).~   "
205222|NCT00875355|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. It is not yet known whether~     radiation therapy is more effective when given alone or together with temozolomide in~     treating brain metastases secondary to breast cancer.~      PURPOSE: This randomized phase II trial is studying how well radiation therapy given together~     with temozolomide works compared with radiation therapy given alone in treating women with~     brain metastases and breast cancer.~   "
205223|NCT00875342|"~     This study proposes to evaluate the effects of D-cycloserine (DCS) combined with~     cognitive-behavioral treatment with exposure therapy in a sample of patients who developed~     posttraumatic stress disorder (PTSD) as a consequence of various traumas (e.g., motor vehicle~     and accidents, burns and other injuries, combat, World Trade Center attack, etc.). In~     addition, this study hopes to determine whether a common human genetic single nucleotide~     polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF SNP~     (Val66Met), predicts treatment response to PTSD.~      Patients living in areas that are not geographically proximal to the Weill-Cornell Medical~     Center New York City campus will receive cognitive behavioral therapy using telemedicine~     (videoconferencing technology).~      Overall, this study aims 1) to determine if subjects administered DCS show a significantly~     larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to~     determine if subjects administered DCS show a decrease in PTSD symptomatology significantly~     earlier (as measured by weeks) than those administered a placebo, 3) to determine if~     differences in symptomatology are evident at a 6-month follow-up and indicate long-term~     differences between groups, 4) to determine if the BDNF SNP predicts treatment response, 5)to~     determine if it is feasible and acceptable to provide imaginal exposure (IE) therapy for PTSD~     using videoconferencing technology.~   "
205224|NCT00875329|"~     Goal: The ultimate goal of this research program is to improve the health and quality of life~     for wounded warriors from Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) through~     screening, risk assessment, and outcome measurement.~      Purpose: The purpose of this study is to evaluate the reliability and validity of the~     existing Traumatic Brain Injury (TBI) Clinical Reminder Screen for OEF/OIF Veterans.~   "
205225|NCT00875316|"~     Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's~     disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in~     both healthy volunteers and Parkinson's disease patients and to determine if there is a~     difference in the way that the body deals with Cogane (pharmacokinetics) between these two~     groups.~      It is expected that the study will prove that Cogane™ is safe and well tolerated and will~     provide us with a pharmacokinetic profile for both subject groups.~   "
205226|NCT00875303|"~     Play Nicely, is a 40 minute, interactive, media-rich, CD ROM that teaches parents, health~     care professionals, counselors, and child care workers/teachers the basics in aggression~     management for children ages 1-7. For more information about the program and to review~     results of previous studies, see www.playnicely.org. The objective of this study is to~     determine if using this brief intervention during the well child visit can affect parents'~     plans to discipline their children.~   "
205227|NCT00875290|"~     The purpose of this study is to see if the use of a real-time glucose sensor improves~     diabetes control in young children (less than 4 years old) with Type I diabetes when they are~     initiated on insulin pump therapy.~   "
205228|NCT00875277|"~     The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its~     combination with calcipotriol and betamethasone using a psoriasis plaque test method.~   "
205229|NCT00875264|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) and~     dose-limiting toxicities of CEP-11981 in patients with advanced, relapsed/refractory solid~     tumors.~   "
205230|NCT00875251|"~     Growth is traditionally used as a prognostic measure after admission to a neonatal intensive~     care unit (NICU). Quality of neonatal intensive care is one of the factors determining the~     health and quality of life for those that survive, with the principal objective of increasing~     disability-free survival. Nowadays, there is some researches showing us that these preterm~     babies present a different body composition when they achieve term age compared with babies~     birth at term and this condition could be putting these babies in risk to metabolic syndrome~     early in adult age. The majority of infants born between 24 and 29 weeks of gestational age~     fail to achieve the mean birth weight for fetuses of the same gestational age, and many weigh~     below the 10th percentile at hospital discharge. The focus of this study is the growth and~     body composition of very low birth weight infants growing in the extrauterine environment.~     The central question is, when they reach the corresponding term weight, is the body~     composition of newborns growing outside of the uterus different from that of infants growing~     in the intrauterine environment? The investigators are also trying to validate 3 different~     methods to research body composition: DXA, air-displacement plethysmography and electric~     bioimpedance.~   "
205242|NCT00875095|"~     The purpose of this study is to establish a new criteria with which to judge the quality of~     sperm samples submitted for artificial reproductive treatments. It is believed that this type~     of testing can compliment the traditional semen analysis to better drive patient care.~   "
205231|NCT00875238|"~     RATIONALE: Studying samples of blood and tissue in the laboratory from women receiving~     doxorubicin and trastuzumab for breast cancer may help doctors learn more about changes that~     occur in DNA and identify biomarkers for increased risk of cardiac effects.~      PURPOSE: This clinical trial is studying side effects involving the heart in women with~     breast cancer receiving doxorubicin and trastuzumab.~   "
205232|NCT00875225|"~     The purpose of this study is to test an interactive DVD intervention to encourage patients to~     stick to their blood pressure medication in order to achieve blood pressure control for~     African American patients. The intervention will convey health messages through personal~     patient stories who have dealt with or continue to struggle with high blood pressure.~      Hypothesis 1: At the end of 9 months a higher proportion of patients randomized to the~     intervention group will achieve appropriate blood pressure control.~      Hypothesis 2: At the end of 9 months a higher proportion of patients who randomized to the~     intervention group will report high adherence to their hypertension medications.~   "
205233|NCT00875212|"~     The aim of this study was to investigate the buffering effect of a calcium~     glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic~     challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part~     in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the~     volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the~     volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per~     million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm,~     respectively). The pH measurements were taken from a single-site using a microelectrode, with~     salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference~     electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a~     cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets~     of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after~     test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12~     hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.~   "
205234|NCT00875199|"~     This study is designed to evaluate the feasibility and provide preliminary evidence for~     efficacy of a 12-week contingency management intervention to promote weight loss in~     overweight and obese low income adults in a community-based clinic. The study has three~     primary goals: (a) to determine if the contingency management treatment can be effectively~     applied to a new application, weight loss; (b) to obtain preliminary evidence for contingency~     management's efficacy in promoting weight loss and improving treatment retention, diet~     quality, physical activity levels, and self efficacy; and (c) to identify barriers and~     challenges to implementing contingency management for weight loss among low income patients.~   "
205235|NCT00875186|"~     The aim of this study was to assess the efficiency of aerobic physical exercise (APE) on~     weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y~     Gastric bypass (RYGBP).~   "
205236|NCT00875173|"~     Background:~      Chagasic myocardiopathy caused by the protozoa Trypanosoma cruzi has been the principal cause~     of cardiac death in Latin America. Without any trypanocidal therapeutic intervention,~     infected subjects can pass from the indeterminate to the cardiac form with heart dysfunction.~     Our group has studied the role and the effect of the supplementation with the essential~     micronutrient selenium (Se) on T. cruzi infection, and the investigators have verified that:~        1. low Se levels is related to the severity of the myocardiopathy in chagasic patients~        2. adequate Se diet is essential for mice survival at the acute phase of the experimental~          T. cruzi infection~        3. Se supplementation prevented the myocardial lesions at the acute phase in mice. From~          these findings and considering that Se supplementation was able to prevent Keshan~          cardiopathy, to revert electrocardiographic and echocardiographic alterations in~          patients nourished by parenteral route, and reduced re-infarction and cardiac deaths~          from acute myocardial infarction; the investigators purpose to investigate if Se~          treatment via oral route, is able to impair the progress of heart dysfunction in~          chagasic patients expressed by the study of progression rate and by the comparison of~          the means of ventricular ejection fraction.~      Methods:~      The Selenium treatment and Chagasic Cardiopathy (STCC) trial is double-blind, placebo~     controlled, randomized in 130 chagasic patients at the chronic phase following the inclusion~     criteria of (a) altered ECHO (LVEF between 0,35 % and 45 %), (b) age between 20 and 65 years,~     (c) randomly divided in two groups: Placebo (n=65) and Se (n=65). Patients of Se group will~     intake diary 100 µg Se as sodium selenite for 12 months. The primary endpoint is the~     reduction of 50 % in the progression rate of heart dysfunction, and the secondary endpoint is~     a partial or total reversion in electrocardiography alterations.~      Conclusion:~      This trial was recently approved by Brazilian Research Ethics Committee and will be conducted~     in accordance with the principles for human experimentation. If the investigators confirmed~     the benefit of Se treatment, a strategy of utilization a micronutrient in an adequate~     concentration as a treatment in diary diet can revolutionize the therapeutic for chagasic~     myocardiopathy.~   "
205237|NCT00875160|"~     This is an open-label study designed to assess if AT2101 is safe in patients with Gaucher~     disease and how AT2101 gets through the body after it is taken by mouth. The study is being~     offered to adult patients with type 1 Gaucher disease who are currently receiving a stable~     dose of enzyme replacement therapy (ERT) with imiglucerase. During the study, subjects will~     not be receiving ERT (up to 35 days).~      The study consists of a screening period (~14 days), a treatment period (12 days) and a~     follow-up period (7 days after last dose). At two points in the study, subjects will be~     housed in an in-patient treatment facility for 3 days/2 nights to accommodate all necessary~     blood draws.~   "
205238|NCT00875147|"~     Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative~     outcome after resection of colorectal liver metastases.~   "
205239|NCT00875134|"~     This study is designed to test the ability of a computer-based algorithm to detect and~     intervene in cases of narcotic-induced respiratory depression.~   "
205240|NCT00875121|"~     This study examines the effects of increasing the cost of social interactions and food on~     overweight and non-overweight youth. Using a computerized operant task youth will earn points~     exchangeable for food and social activity.~      The investigators predict that both overweight and non-overweight children will substitute~     food for interactions with an unfamiliar peer when this alternative is made expensive. Also,~     the investigators predict that both overweight and lean participants will defend their choice~     to spend time with a friend even when this alternative is made expensive.~   "
205241|NCT00875108|"~     Follow-on study to the VIAject™-08J study to evaluate the long-term safety and efficacy of~     VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 2~     diabetes mellitus.~      The VIAject™-08J study is the efficacy and safety study for insulin VIAject™ to demonstrate~     equivalent blood glucose control in patients with type 2 diabetes mellitus with VIAject™~     insulin or regular human insulin as prandial insulin and to demonstrate an equivalent safety~     profile for VIAject™ in comparison to human insulin.~   "
214549|NCT00751413|"~     To evaluate the safety, tolerability and plasma levels of single oral doses of MK0633 in~     pediatric asthma patients ages 6 to less than 12 years.~   "
205243|NCT00875082|"~     Airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced~     airway remodelling features not modulated by corticosteroids, are reversible by CysLT1~     receptor blockade therapy in animals. No data are available, at the present, about the~     potential effect of LTs receptor antagonists on airway remodelling in asthmatic children.~      In the present study, the investigators aim to assess whether the addition of montelukast to~     ICS in mild asthmatic children to inhibit the release of MMP-9, TIMP-1, MMP-12, MMP-9/TIMP1~     ratio, procollagen type I C-terminal peptide (PICP) and TGF-beta in the airway fluid~     collected by induced sputum in asthmatic children. 30-40 atopic children with mild persistent~     asthma.~      Children with asthma will be recruited and evaluated with a real life open label trial: they~     will be randomised into two groups at first visit (T1): 1) group A: in these patients~     montelukast tablets 5 mg and as needed beta agonist will be administered; 2) group B: in~     these patients beta agonist therapy only.~      All children will be evaluated after 8 weeks (T2). They will be tested for lung function,~     FeNO, metalloproteinase (MMP)-9, MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1),~     procollagen type I C-terminal peptide (PICP) and TGF-beta1 levels in sputum.~   "
205244|NCT00875069|"~     The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock~     solution in preventing major catheter related infections in critically ill patients.~   "
205245|NCT00875056|"~     This study evaluates safety and tolerability of MK0683 and efficacy of MK0683 in patients~     with relapsed and/or refractory FL. Exploratory purpose of this study is to evaluate efficacy~     of MK0683 in patients with relapsed and/or refractory other Indolent B-NHL or MCL.~   "
205246|NCT00875043|"~     The purpose of this study is to provide data that would give the investigators a better~     understanding of the physiologic changes that occur and may contribute to post operative~     blindness. An improved understanding may lead to the development of protocols or devices that~     reduce the chance of catastrophic visual loss.~   "
205247|NCT00875030|"~     The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg)~     Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is~     the World Health Organization Reference standard for artesunate The secondary objective is to~     assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).~   "
205248|NCT00875017|"~     The purpose of this study is to compare the absorption of dietary phosphorus following a~     single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate~     (2400mg).~   "
205249|NCT00875004|"~     RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or~     reduce side effects in patients undergoing chemotherapy for solid tumors.~      PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing~     chemotherapy for solid tumors.~   "
205250|NCT00874991|"~     The aim of this research is to apply cardiac tissue characterization in order to assess left~     ventricular function in cardiac surgical patients pre and post cardiopulmonary bypass. The~     procedures to be used include a retrospective review of transesophageal images obtained~     during conventional intraoperative transesophageal echocardiography (TEE) for cardiac~     surgery, as well as a secondary analysis with Tissue Doppler. The results will be compared~     with hemodynamic data obtained from a pulmonary artery catheter (PAC).~   "
205251|NCT00874978|"~     The purpose of this study is to evaluate the efficacy of lenalidomide treatments to achieve~     haematopoietic improvement in subjects with low- or intermediate-1 risk International~     Prognostic Scoring System1 (IPSS) myelodysplastic syndrome (MDS) associated with a del~     (5q31-33) cytogenetic abnormality.~   "
205252|NCT00874965|"~     This study was designed to test the following hypothesis:~      The benefit of electrostimulation training will be greater than sham stimulation training in~     term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of~     ventilation during exercise and quality of life in COPD patients~   "
205253|NCT00874952|"~     The aim of the study, is to assess the prevalence of metabolic syndrome in Italy on a~     regional basis, defined according to National Cholesterol Education Program/Adult Treatment~     Panel III (NCEP/ATPIII) guidelines criteria.~   "
205254|NCT00874939|"~     This study will evaluate acute symptomatic improvements in cognitive performance in healthy~     elderly participants with mild-to-moderate Alzheimer's disease. A four-week pilot study will~     first evaluate the CogState computerized cognitive battery in participants who are not~     receiving treatment. After completion of the pilot study, participants will be randomized to~     receive Placebo, Donepezil 5 mg, MK-0249 7.5 mg, and MK-0249 25 mg. After each drug~     administration the participants will be given the CogState computerized cognitive battery to~     assess cognitive performance. The primary hypotheses are that cognitive performance in~     participants with Alzheimer's disease, or in healthy participants, is improved by the~     administration of a single oral 5 mg dose of Donepezil as compared to placebo.~   "
205255|NCT00874926|"~     The aim of this international prospective, non-interventional post-marketing surveillance~     study is to obtain data on treatment procedures, long-term safety and efficacy and patient~     acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life~     treatment conditions.~   "
205256|NCT00874913|"~     Obstructive sleep apnea syndrome (OSAS) is a common disease, with a prevalence evaluated~     between 5 - 7% in the general population. OSAS is characterized by recurrent episodes of~     partial or complete upper airway obstruction during sleep, which are nearly systematically~     associated with a desaturation-reoxygenation sequence, an admitted detrimental stimulus for~     the cardiovascular system. It has now been demonstrated that OSAS per se is able to generate~     hypertension, atherosclerosis and autonomic dysfunction (high sympathic tone and increase in~     baseline heart rate), all conditions possibly interacting with ocular vascular regulation.~     OSAS has major consequences on the ocular level since it is associated with a higher~     frequency of optic neuropathies, such as glaucoma and nonarteritic ischemic optic neuropathy~     (NAION), both with functional severe prognosis. Most of vascular changes associated with OSAS~     have been studied at the level of macrovasculature. In terms of physiopathology, the main~     effects on the vascular system in OSAS are sympathetic hyperactivity, oxidative stress,~     development of endothelial dysfunction, systemic inflammation and metabolic alterations such~     as the appearance of insulin resistance. All these mechanisms can affect the microcirculation~     of the eye, especially the optic nerve and choroid. Our hypothesis is that the eye~     microvasculature is affected by OSAS, and these lesions may be detected via a reduced~     autoregulation of blood flow in humans.~      This project aims to demonstrate, quantify, and analyze the vascular modifications of the eye~     associated with OSAS trough a comparative clinical study on glaucoma patients and OSAS~     patients and matched healthy subjects for the regulation of the eye blood flow using confocal~     laser Doppler flowmetry (LDF). The regulation of the ocular blood flow will be assessed using~     several stimuli and measured using a new confocal LDF.~   "
214550|NCT00751400|"~     The purpose of this Study is to assess how subjects will use the investigational product in~     an uncontrolled, naturalistic environment.~   "
205257|NCT00874900|"~     The purpose of this study is to determine the effect on knowledge and behavior of playing an~     educational asthma computer game during a pediatric Emergency Department (ED) asthma visit~     among children ages 7 - 15 years. The ED cares for a high-risk population of children who~     have difficulty accessing preventive care well. The addition of a computer game to usual~     asthma emergency care could be a simple, effective, enjoyable way to improve patients' asthma~     knowledge, beliefs, and management practices. This project has the potential to lead to~     larger studies evaluating the benefit of education with and without behavioral interventions~     such as motivational interviewing.~      This project plans to implement and evaluate the use of a goal setting activity and the~     educational asthma computer game, Quest for the Code (Starlight Starbright Children's~     FoundationTM), in the ED of Seattle Children's Hospital. In a randomized trial of Spanish and~     English speaking children ages 7 - 15 years receiving ED care for their asthma, the~     investigators will evaluate the effects of the game on children's asthma knowledge,~     attitudes, and behaviors.~      The investigators aim to compare the change in asthma knowledge and locus of control after 3~     months, for children who play the computerized asthma game, versus those who receive standard~     care in the ED. The investigators will also compare changes in asthma severity and activity~     limitations over 3 months, for children who play the asthma game without goal-setting,~     children who playing the game with goal-setting, and children who receive standard care.~      Overall, the investigators hypothesize that educational asthma game play by pediatric~     patients with acute asthma will improve asthma knowledge, compared with standard care.~   "
205258|NCT00874887|"~     The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the~     study eye affects the development of resistant bacteria on the conjunctiva based upon changes~     in the surface flora over the course of 2 weeks of topical treatment in healthy adult~     subjects.~   "
205259|NCT00874874|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with~     angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.~   "
205260|NCT00874861|"~     This is a pilot vaccine study in adults with recurrent WHO Grade II gliomas. The purpose of~     this study is to test the safety and efficacy of an experimental tumor vaccine made from~     peptides in combination with the study drug Poly-ICLC.~      Poly-ICLC, manufactured by Oncovir, Inc., has already been received and is generally well~     tolerated by subjects in earlier studies and has been shown to decrease the size of brain~     tumors in some cases.~      The immunological and safety data will be used to decide whether a larger study of clinical~     efficacy is warranted.~   "
205261|NCT00874848|"~     The Phase 2 study described in this protocol will serve to evaluate the antitumor activity,~     safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and~     concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced~     NSCLC. Additionally, this study will provide guidance for the design of more definitive~     efficacy studies of Imprime PGG in NSCLC patients.~   "
205262|NCT00874835|"~     The purpose of this study is to determine whether the surgical outcomes in patients~     undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of~     an insertion device over the traditional forceps insertion method.~   "
205263|NCT00874822|"~     The study hypothesis is that the prevalence of obstructive sleep apnea in patients presenting~     for total knee or total hip arthroplasty is higher than generally suspected. The study will~     include just one arm and results will be compared to a literature control group. Patients~     refered for preoperative evaluation will be screened using a standard questionnaire. Those at~     high risk of obstructive sleep apnea will then undergo a formal overnight sleep study~     (polysomnography).~   "
205264|NCT00874809|"~     The main purpose of this study is to determine the number of daily basal insulin rate changes~     that are needed to achieve short-term near normal glucose control in insulin pump patients~     with type 2 diabetes~   "
205265|NCT00874796|"~     This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter~     study investigating the safety, tolerability and efficacy of two oral doses of GS-9450 in~     adults with chronic Hepatitis C Virus (HCV). Approximately 240 subjects 18-65 years of age~     who meet study entry criteria will be randomized (in other words, selected at random, like~     flipping a coin) to one of three treatment groups (80 subjects per treatment group) as~     follows:GS-9450 10 mg once daily,GS-9450 40 mg once daily, or matching placebo once daily.~      Following randomization, subjects will return within seven business days for a Baseline (Day~     1) visit, at which time study medication will be dispensed and subjects will enter a 26 week~     treatment phase. During the treatment phase, subjects will receive study drug once daily for~     24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug~     once every other day for one week and then every 3 days for one week. Following completion of~     the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.~   "
205266|NCT00874783|"~     Human fibroblasts and possibly other human somatic cells may be reprogrammed into induced~     pluripotent stem (iPS) cells by the forced expression of transcription factors (1-5). The iPS~     cells seem to share many properties with human embryonic stem cells.~      Induced pluripotent stem cells potentially may be useful in the future as an unlimited source~     of cells for transplantation.~      The major goal of the project is to develop human iPS cells from cell cultures from skin~     biopsies or the patient's hair. The iPS cells will be developed primarily for modeling~     diseases and drug discovery as well as basic research, and for developing the technology that~     may eventually allow the use of iPS cells for future transplantation therapy. The iPS cells~     developed in the course of this application are not intended for use in transplantation~     therapy. Future development of iPS cells for clinical transplantation therapies will be~     subjected to the appropriate authorization by ethical and regulatory committees.~   "
205267|NCT00874770|"~     The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in~     combination with pegylated interferon alpha and ribavirin, are safe and demonstrate~     sufficient anti-hepatitis C virus activity.~   "
205268|NCT00874757|"~     The purpose of this study is to see whether Statin drugs will act as anti-inflammatories. The~     investigators will study this potential anti-inflammatory activity in healthy subjects.~   "
215119|NCT00743860|"~     This study is designed to assess the pharmacokinetics of darapladib and its metabolites~     following single and 28 days of repeat dosing of darapladib.~   "
205270|NCT00874731|"~     To assess the potential for ridaforolimus to prolong the QTc interval (an effect on the~     electrical activity of the heart) in participants with advanced cancer. This study will be~     done in 2 parts. Part 1 will evaluate the effect of a single 100 mg dose of ridaforolimus on~     QT interval in participants with advanced cancer. Fridericias's correction (QTcF) will be~     used. In Part 2 participants will receive ridaforolimus at the current therapeutic dose (40~     mg x 5 days).~   "
205271|NCT00874718|"~     The study consists of evaluating the efficacy of an Educational Program for prevention of~     occupational musculoskeletal problems in workers. It is a randomized clinical trial with~     parallel groups and blinded evaluator, with a control group not submitted to the educational~     program, but that received a program for general orientation in health. The primary outcome~     was the change of the quality of life measured by means of Medical Outcomes Study 36-Term~     Short Health Survey (SF-36), that it is a generic instrument of evaluation of the quality of~     life, translated and validated in Portuguese of Brazil.~   "
205272|NCT00874692|"~     The purpose of this study is to evaluate the impact of a passive safety measure, namely a~     reduction in centrally controlled hot tap water temperatures in social housing using a boiler~     management system, as an effective public health intervention.~   "
205273|NCT00874679|"~     The aim of this prospective, non-interventional post-marketing surveillance study is to~     obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction.~     Furthermore, the data collection particularly focuses on the experience of the patient and~     his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients~     will be included in the study.The maximum observation period per patient is 12 months.Besides~     the physician's documentation, the patient should fill out a questionnaire at every visit.~     The questionnaires will be handed out and collected by the physician. Furthermore, an~     additional questionnaire for the patient's partner can be distributed at each visit in case~     the partner is willing to participate.~   "
205274|NCT00874666|"~     This study will measure the bioavailability of allicin, the main active compound of garlic,~     from garlic supplements and garlic foods (raw, cooked, processed) so that~        -  supplement manufacturers and clinical investigators know how supplements need to be made~          and consumed to obtain high bioavailability~        -  consumers can know how garlic can be prepared to obtain any established health benefits~          of garlic.~   "
205275|NCT00874653|"~     The purposes of this study are:~        -  To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual~          bleeding treatment by Mirena.~        -  To collect italian data for Mirena in clinical routine.~   "
205276|NCT00874640|"~     To evaluate patient characteristics in the current daily radiological practice of Gadovist~     application. Special focus will be laid on the individual risk factors of patients, the~     indications for and the dose of Gadovist application.~      Secondary objective is to prove the known safety profile (especially rare adverse events) of~     Gadovist and to collect data on handling problems with different application forms (one~     questionnaire per center).~   "
205277|NCT00874627|"~     Sublingual immunotherapy is developing in the treatment of aeroallergens allergy. The~     hypothesis is that such process may be applied to food allergy, more precisely to milk. A~     previous series of 8 patients indicates the likely effectiveness of this technique (Allergy,~     2006).~   "
205278|NCT00874614|"~     This clinical trial is designed to evaluate the effectiveness and collect additional safety~     information on AZEDRA® (iobenguane I 131) for the treatment of metastatic or~     relapsed/refractory (to other treatment) or unresectable pheochromocytoma or paraganglioma.~      The purpose of this trial is to test the use of AZEDRA® as a treatment for pheochromocytoma~     and paraganglioma, a rare disease. This Phase II study will help determine primarily if using~     the drug reduces the amount of blood pressure medication being taken as a result of the~     cancer and secondarily to determine such things as the effectiveness of the study drug in~     treating the cancer, additional safety measures, and to assess if the drug helps the quality~     of life and use of pain medication. All subjects will receive an imaging dose with scans~     followed by two therapeutic doses given approximately 3 months apart.~   "
205279|NCT00874601|"~     The manipulation of blood pressure in acute cerebral ischemia has been a matter of debate~     until now. The investigators are clearly in need of more detailed data on how~     antihypertensive treatment affects outcome in acute phase of stroke.~      This study will assess the effects of modest blood pressure (BP) lowering manipulation in~     acute period of ischemic stroke on death or dependency at 90-day.~   "
205280|NCT00874588|"~     The purpose of this study is to evaluate the safety, tolerability, immune response and~     clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, CDCA1,~     VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.~   "
205281|NCT00874575|"~     The purpose of the study is to~        -  Test the effect of a dietary supplement beta-hydroxy-beta-methylbutyrate (HMB) with and~          without Vitamin D to prevent and reverse the losses of muscular strength and~          functionality in older adults.~      The second aim of the study is to determine if HMB and Vitamin D improves markers of bone~     turnover in adults aged 60 plus years. HMB is a dietary supplement that comes from the amino~     acid leucine. HMB is found in foods and is made in your body after you eat protein (meat).~     Subjects will be randomized to one of four dietary supplement groups and will participate in~     a 3-day per week exercise program for 12 weeks. Each exercise day will be about 60 minutes~     long consisting of strength training exercises utilizing Theraband® stretch cords and~     jumping.~      Subjects will consume the dietary supplement 2 times per day for 12 weeks. Tests will consist~     of the following:~        -  Measuring the strength of subjects' legs by using a Isokinetic Dynamometer~        -  Measuring body composition~        -  Measuring hand-grip strength using a hand-grip dynamometer~        -  Measuring functional mobility, balance and agility by the time it takes for you to rise~          from a chair, walk around a cone 8 feet in front of the chair and return to the chair~          (Up-&-Go Test~        -  Filling out questionnaires and having blood drawn for biochemical measurements. Testing~          will be performed at the beginning and at 4, 8 and 12 weeks.~   "
205345|NCT00873730|"~     The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg~     twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis~     (AS) and previous failure to usual practice therapies in Spain.~   "
218615|NCT00697541|"~     Phase II systemic bioavailability crossover study to measure the exposure of Col-118 topical~     0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2%~   "
205282|NCT00874562|"~     This is a research study designed to look at the biological effects of two drugs on leukemia~     cells. In this study, we are comparing the effects of drugs called corticosteroids when used~     alone or with another drug called rapamycin. Rapamycin is a drug that prevents the body's~     immune system from working normally. It has been used for many years after kidney transplants~     to prevent rejection of the organ. Recent work suggests that rapamycin may also help treat~     leukemia and other cancers.~   "
205283|NCT00874549|"~     Safety:~      To describe the rates of immediate reactions, solicited injection-site and systemic~     reactions, all unsolicited adverse events, and serious adverse events following vaccination~     with either Menactra® vaccine or Menomune® vaccine.~      Immunogenicity:~      To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study~     groups.~   "
205284|NCT00874536|"~     It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity~     disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty~     acids have been used in this setting, yet results are conflicting. The parent omega-3 fatty~     acid alpha-linolenic acid (ALA) has only been used in one trial. 40 children diagnosed with~     ADHD will be randomized to consume either ALA or placebo for two months. Baseline and end~     assessments will include ADHD-related questionnaires and a computerized test. The~     investigators hypothesize that ALA supplementation will prove beneficial for children with~     ADHD.~   "
205285|NCT00874523|"~     To compare the steady-state pharmacokinetics and short-term efficacy and safety of two dosing~     strategies of raltegravir and atazanavir in virologically suppressed HIV-infected adults~     receiving atazanavir-containing combination antiretroviral therapy.~   "
205286|NCT00874510|"~     This study will consist of a randomized controlled trial in which the investigators test the~     feasibility and effectiveness of mandatory nap programs for physicians in training. One site~     will be the general medical service of the Philadelphia Veterans Affairs Medical Center. The~     other will be the oncology service of the Hospital of the University of Pennsylvania. The~     primary outcome will be the amount slept while on call. The first year will test the efficacy~     of a 5 hour mandatory nap schedule, the second year will test the efficacy of a 3 hour~     mandatory nap schedule.~   "
205287|NCT00874497|"~     Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the~     pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.~   "
205288|NCT00874484|"~     The investigators hypothesize that injections of Low molecular weight heparin (LMWH)~     [enoxaparin] will reduce pain in women with vulvodynia.~   "
205289|NCT00874471|"~     Uveitis is a group of troublesome diseases that collectively represent a cause of blindness~     comparable to diabetes. Most forms of uveitis are either infectious or immune-mediated. The~     investigators propose to create a data base on peripheral blood gene expression for patients~     with 3 of the most important diseases associated with uveitis: ankylosing spondylitis,~     sarcoidosis, and Behcet's disease. The investigators will quantitatively measure the~     expression of consistent alteration in peripheral blood from patients with more than 40,000~     gene sequences using microarray gene chip technology. This approach is known to detect~     systemic immune-mediated disease. The investigators will use this data base to:~        1. Determine if patients with uveitis and ankylosing spondylitis, sarcoidosis, or Behcet's~          can be distinguished from a normal population or controls with the same systemic disease~          but no history of uveitis~        2. Determine if the profile of gene expression can distinguish infectious or idiopathic~          forms of uveitis from patients with spondylitis, sarcoidosis, or Behcet's~        3. Determine how this gene profile changes over time as episodic disease such as~          spondylitis or Behcet's activates or remits~        4. Correlate the changes in gene expression with the prognosis of the ocular inflammatory~          process.~      The creation of a gene expression data base for patients with uveitis has the potential to~     clarify the pathogenesis of disease, establish new diagnostic tools, and provide a means for~     predicting prognosis.~   "
205290|NCT00874458|"~     RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and~     find out how far the disease has spread.~      PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women~     with ductal carcinoma in situ.~   "
205291|NCT00874445|"~     The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt~     biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration.~   "
205292|NCT00874432|"~     The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs~     primarily used to treat hypertension or congestive heart failure) to prevent or delay~     cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining~     their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled~     study.~   "
205293|NCT00874419|"~     Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) such as erlotinib~     have proved effective in second or third line therapy for advanced non-small cell lung~     cancer(NSCLC).It is well tolerated without the side effects usually associated with~     chemotherapy. The mutations in EGFR exons 19 or 21 have been reported to be associated with~     efficacy of EGFR TKIs.Based on the encouraging preliminary results from the Spanish lung~     cancer group' prospective study reported that the efficacy of Tarceva as first line treatment~     for metastatic NSCLC patients with EGFR mutation would delay disease progression,prolong~     overall survival and be well tolerated, medium Progression-free survival(PFS) was around 12~     months and OS reach 24 months，our study is designed to compare PFS between the patients with~     mutant EGFR treated by gemcitabine/carboplatin and those by erlotinib in the first-line~     setting. We assumed 11 months of PFS on Tarceva arm versus 6 months on chemotherapy arm with~     a=0.025(alpha-spend for an interim analysis), 80% power and 12 months enrolment period, 12~     months FU duration to calculate the sample size. The sample size is 69 pairs. Considering~     about 10% drop-out rate, the final sample size is 152 patients.So, chemo-naive staged IIIb/IV~     patients with EGFR mutations in exon 19 or 21 will be enrolled into this open-label,~     randomized,multicenter phase III study.~   "
205294|NCT00874406|"~     The purpose of this study is to investigate whether preoperative TAC is able to improve~     progression free survival and overall survival in patients receiving liver metastasis~     resection of colorectal cancer.~   "
205564|NCT00870831|"~     To follow the patterns and natural history of Islet Transplant recipients (the ones that were~     involved in the Modified Edmonton Protocol) using oral glucose to check sugar levels as well~     as insulin and C-peptide over the course of 5 years~   "
205295|NCT00874393|"~     This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized,~     double-blinded study of blood pressure management within 12 months. Eligible infants will~     receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone~     or a normal saline placebo).~      Enrolled infants will be randomized to receive one of the following drug pairs:~        -  dopamine and hydrocortisone~        -  dopamine and normal saline~        -  dextrose and hydrocortisone~        -  dextrose and normal saline.~      In addition to the intervention above, the NRN is conducting a 6-month time-limited~     prospective observational study of all infants born at an NRN center between 23 and 26 weeks~     gestational age. All clinical decisions made for these babies will be at the discretion of~     the attending neonatologist/infant care team according to standard practice at each~     institution. Data on blood pressure management in the first 24 postnatal hours collected for~     each infant.~   "
205296|NCT00874380|"~     Our research involves the detailed description of the content of the diet of x dialysis~     patients.~      For our purpose we used a newly developed food frequency questionnaire. This is the first~     validated questionnaire specific for dialysis patients and we were the first to use it.~      Our special focus was the fiber content in the diet of our patient. Our thesis that they are~     way below the recommended guidelines for fiber intake was verified. Our follow will evaluate~     the effect of such at diet, mosTLy cardiovascular.~   "
205297|NCT00874367|"~     In this observational study, the NICHD Neonatal Research Network (NRN) is conducting~     surveillance of all infants born at NRN centers to identify all newborns who are diagnosed~     with early-onset sepsis (EOS) and/or meningitis. The study will: establish current~     hospital-based rates of EOS among term and preterm infants in the era of intrapartum~     antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare~     asymptomatic and symptomatic infants by gestational age and pathogen; and monitor~     sepsis-associated mortality rates by pathogen group.~   "
205298|NCT00874354|"~     This research is being done because currently there is no effective way in regenerating or~     replacing the heart muscle that has been damaged after a heart attack.~      The purpose of this study is to test whether injecting cells obtained from the patient's bone~     marrow into the coronary artery can regenerate and replace heart tissue to strengthen heart~     and prevent heart from dilating and developing heart failure.~   "
205299|NCT00874341|"~     Current evidence indicates that fruit and vegetable intake and dietary patterns rich in fruit~     and vegetables may be associated with reduced insulin resistance and may reduce the risk of~     the metabolic syndrome. If proven, this relationship may partly explain the inverse~     association between fruit and vegetable intake and cardiovascular disease risk. There are~     currently no published dietary interventions that have examined in detail the relationship~     between fruit and vegetable intake and insulin resistance. There is, however, some~     preliminary evidence from whole diet interventions that a diet rich in fruit and vegetables~     may have a beneficial effect on insulin resistance. Evidence to date indicates that an~     investigation of the direct association between fruit and vegetable intakes and insulin~     resistance in a carefully controlled intervention study is warranted. This study will~     investigate the dose−response effect of fruit and vegetable intake on insulin resistance in~     people who are overweight and at high−risk of CVD using state−of−the−art techniques.~   "
205300|NCT00874328|"~     The irinotecan and cisplatin combination showed significant anti-tumor activity. In the~     first-line setting, the investigators showed that this regimen had significant anti-tumor~     activity in 47% of chemo-naïve NSCLC patients with 1-year survival rate of 64.2%. Again, the~     investigators showed that the second-line Irinotecan and cisplatin is an active and~     well-tolerated regimen in patients with advanced NSCLC pretreated with non-platinum based~     chemotherapy.~      TS-1 (Jeil Pharmaceutical Co.,Ltd, Seoul, Korea) is an oral anticancer drug comprised of~     tegafur, 5-chloro-2, 4-dihydroxypyridine and potassium oxonate, in a molar ratio of 1:0.4:1.~     Tegafur is a prodrug that generates 5-fluorouracil (5-FU) in blood via metabolism by liver~     enzyme, and 5-chloro-2, 4-dihydroxypyridine enhance the serum concentration of 5-FU by the~     competitive inhibition of dihydropyrimidine dehydrogenase, an enzyme responsible for 5-FU~     catabolism. Potassium oxonate is also a reversible competitive inhibitor of orotate~     phosphoribosyl transferase, a phosphoenzyme for 5-FU. Diarrhea induced by 5-FU administration~     is though to be attributable to the phosphorylation of 5-FU by the enzyme in the~     gastrointestinal tissue. After oral administration of potassium oxonate, the concentration of~     potassium in the gastrointestinal tissue is high enough to inhibit the enzyme while the~     concentration in blood and tumor is reported to be either slight or nil. Because of these~     mechanism, oral TS-1 administration generates a higher concentration of 5-FU than protracted~     intravenous infusion of 5-FU given in a dose equimolar to the tegafur in S-1, whereas the~     incidence of adverse events concerning the GI tract does not increase. In a phase II trial of~     TS-1 as first-line setting in NSCLC, the response rate was 22% and the median survival time~     was 10.2 months. As expected, the incidence of severe gastrointestinal adverse events was~     low, and so was few severe hematologic toxicity. Recently 3-weekly TS-1 plus cisplatin showed~     activity against NSCLC with a response rate of 32.7% and the safety was acceptable.~   "
205301|NCT00874315|"~     RATIONALE: - Relapsed or refractory Neuroblastoma (NBL) carries a very poor prognosis and~     children with relapsed NBL have an overall 3 year survival rate of < 10%. Hematopoietic Stem~     Cell Transplant from a different donor (allogeneic), is a form of adoptive cellular therapy ,~     such that infused donor cells find host tumors as foreign and fight them. After transplant,~     the donor immune cells (i.e. T cells, NK cells) mediate Graft versus Tumor (GVT) effect and~     may stop tumor from recurring. Also,reduced intensity transplants lead to minimal toxicity~     and less risk of mortality in heavily pre-treated NBL patients.~      PURPOSE: This phase II trial is studying how well giving a reduced intensity(using~     Fludarabine, Busulfan and antithymocyte globulin)preparative regimen followed by donor stem~     cell transplant works in treating young patients with high-risk neuroblastoma that has~     relapsed or not responded to treatment.~   "
205302|NCT00874302|"~     Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study~     medication for 4 months. This will be followed by a 6 month off-drug interval until there is~     a return of significant symptomatology. If they experience symptoms of a certain severity,~     the subject will enter a second 4 month treatment cycle and then a follow-up period.~   "
205346|NCT00873717|"~     Elderly persons in long-term facilities often have denutrition, associated with a bad oral~     and dental status. Yet, many elderly persons don't attend dentist care and when they have~     dental prothesis, do not often use them during meals. The impact of a rehabilitation of~     dental function on their nutritional status has not been proven.~      The objective of this study is to assess the impact of 2 strategies aimed to restore a good~     nutritional status, among patients with slight denutrition.~   "
205347|NCT00873704|"~     The purpose of this study was to test the hypothesis that supplemental postoperative oxygen~     reduces the risk of surgical wound infection in patients following lower limb vascular~     surgery.~   "
205348|NCT00873691|"~     The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt~     biphasic waveform and the Tuned biphasic waveform in patients with right-sided implants.~   "
205303|NCT00874289|"~     Acute decompensated heart failure (ADHF) is the leading cause of admission to hospital in the~     US, and is associated with high mortality, morbidity, and major cost to the health care~     system. Much of this cost relates to prolonged hospitalizations from acute deterioration in~     kidney function (AKI), which in turn is associated with further cardiovascular events such as~     recurrent ADHF. Strategies for early detection minimization and prevention of AKI would~     therefore be of tremendous benefit to both the patient and the health care system.~      A common reason for hospitalization in ADHF is that of altered volume status and renal~     impairment. Also, many patients with ADHF have underlying hypertension and/or a recent acute~     coronary syndrome. Hypertension, diabetes and chronic kidney disease (CKD) are independent~     risk factors for cardiovascular disease, and diabetes is the leading cause of CKD. Therefore,~     patients presenting with ADHF are at high risk for CV events, more so if they develop AKI.~     Therefore, strategies to detect changes in renal status early may allow for more rapid~     intervention with appropriate drug and other therapies to attenuate AKI and subsequent~     complications, which may in turn result in prevention of early readmissions with HF.~      Most ADHF patients have underlying chronic heart failure (CHF). CHF is a major cost to the~     health care system. About two thirds of this cost relates to hospitalization for acute~     deterioration in heart failure (HF). Strategies to minimize or prevent HF hospitalization~     therefore are of tremendous benefit to both the patient and the health care system.~      The most frequent reason for hospitalization in a CHF patient is that of altered volume~     status and renal impairment. Therefore, as with ADHF, strategies for early detection of~     changes in renal status may allow for intervention with appropriate drug and other therapies~     to attenuate, or even prevent, the need for the patient to return to hospital.~      Many approaches have been studied in relation to this concept. Deterioration in renal~     function is a harbinger of a need for hospitalization, and indeed a predictor of medium term~     mortality. However, current measures of renal function are relatively crude with a~     considerable lag between an insult to the kidney and its translation to a measurable~     deterioration in renal function reflected by worsening serum creatinine. Thus, diagnostic~     tests that evaluate renal injury which are modulated early in the time course of this process~     may have considerable utility not only in the ADHF setting but also in predicting~     decompensation in the CHF setting.~   "
205304|NCT00874276|"~     To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism.~     This aim test the postulates that MAAI haplotype determines, and thus can predict,1)~     dose-dependent DCA kinetics and biotransformation.~   "
205305|NCT00874263|"~     The recently developed endoscopic Confocal probe microscopy system allows imaging of surface~     epithelium during ongoing endoscopy (upper and lower) with the potential of immediate~     diagnosis of various GI pre-malignant and malignant lesions. The purpose of this study is to~     determine if using this new Confocal probe system can find pre-cancerous abnormalities in the~     stomach and colon.~      Hypothesis: The confocal endomicroscopy images of colorectal lesions during the standard~     colonoscopies could help the classification in vivo of colorectal neoplastic and~     non-neoplastic lesions. This could direct further endoscopic interventions such as targeted~     biopsies of early colorectal cancer lesions and the endoscopic resection of such lesions~     during screening colonoscopies.~      Primary Aim~        1. To determine the key confocal image features of neoplastic and pre-neoplastic colorectal~          lesions including flat and raised adenomatous polyps, intraepithelial neoplasia and~          cancer as well as benign lesions such as hyperplastic polyps and normal colonic~          epithelium and to estimate which morphologic features best distinguish neoplastic and~          non-neoplastic tissues.~           Secondary Aims:~        2. To determine the initial sensitivity and specificity of confocal microendoscopy imaging~          for classification of adenomatous from hyperplastic polyps of the colon.~        3. In this exploratory phase of the study to develop a library of confocal microendoscopic~          imaging characteristics of other GI pathologies such as:~             1. Barrett's esophagus in comparison to Barrett's esophagus with dysplasia, and normal~               squamous esophagus.~             2. Other encountered inflammatory and neoplastic conditions within the GI tract in~               which biopsy or removal of tissue would routinely be indicated.~      The second phase of the study will focus on establishing the sensitivities, specificities,~     accuracy of confocal images of colorectal lesions and other GI pathologies as well as~     inter-observer agreement and learning curve in interpretation of confocal images.~   "
205306|NCT00874250|"~     To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the~     primary treatment of aneurysm of the descending thoracic aorta (DTA)~      > Primary Hypothesis: The proportion of subjects free from a major device event through 1~     month post-treatment will not be significantly less than 0.95, which represents the~     proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis~   "
205307|NCT00874237|"~     The purpose of the present Phase 1 study is to assess the cardiac safety of Staccato Loxapine~     administered to healthy volunteers in a 3 period crossover study.~   "
205308|NCT00874224|"~     The ORANGE II trial is a double blinded randomised controlled trial that will provide~     evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic~     sectionectomy in terms of time to functional recovery, hospital length of stay, quality of~     life, readmission percentage, morbidity and mortality, hospital costs, body image and~     cosmesis, and long term incidence of incisional hernias.~   "
205309|NCT00874211|"~     RATIONALE: Gathering information about how often osteonecrosis of the jaw occurs in patients~     receiving zoledronic acid for bone metastases may help doctors learn more about the disease~     and provide the best follow-up care.~      PURPOSE: This clinical trial is studying osteonecrosis of the jaw in patients with cancer who~     are receiving zoledronic acid for bone metastases.~   "
205310|NCT00874198|"~     The purpose of the study is to determine the predictive values and prognostic accuracies of~     CSF dynamic measures, the TAP -TEST (high-volume cerebrospinal fluid withdrawal), resistance~     to CSF outflow and compliance in the prediction of shunt-treatment outcome in patients with~     idiopathic normal pressure hydrocephalus.~   "
205311|NCT00874185|"~     Evaluate satisfaction in people treated with IPDE5 inhibitors over time~   "
205312|NCT00874172|"~     Quality of life of adult patients with sickle cell disease is deeply impaired by severe~     adverse medical events that inadvertently occur throughout their time life. Indeed, patients~     not presenting a life threatening condition often present to the emergency department with~     sickle cell disease crisis related pain. Currently, the effectiveness of specific analgesic~     strategies for treating sickle cell disease crisis related pain are mostly based on~     acetaminophen and opioid derivates combination along with oxygen delivery. Those strategies~     are effective but may last up to half an hour to obtain pain relief. This delay mostly~     depends on the availability of venous access and on individual patient response to treatment.~     Nitrous oxide is a volatile efficient analgesic therapy that has been repeatedly shown to~     allow rapid analgesia in the emergency department setting.~      The investigators hypothesise that a new analgesic strategy (rapid optimized analgesic~     strategy) including nitrous oxide and nefopam would be as safe and more rapidly effective~     than current analgesic strategy.~   "
205313|NCT00874159|"~     This study is conducted in Asia. The aim of this observational study is to describe the~     diabetes management, control status and complication profile in a diabetic population of~     Philippines.~   "
205314|NCT00874146|"~     Primary objective of the study is to evaluate the correlation between level of HER2-neu gene~     amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to~     progression (TTP) in patients with HER2-positive advanced breast cancer treated with~     trastuzumab-containing regimens.~   "
205349|NCT00873678|"~     Primary objective:~        -  assessment of the prevalence of AHI1 mutations in Joubert syndrome and~          cerebello-oculo-renal syndromes (JS/CORS)~      Secondary objective:~        -  assessment of the prevalence of CEP290 mutations and NPHP1 homozygous deletions in~          JS/CORS~        -  caracterization of mutational spectrum of AHI1, NPHP1, CEP290 genes in JS/CORS.~        -  evaluation of genotype-phenotype correlation in JS/CORS.~   "
205350|NCT00873665|"~     The investigators propose a single-site, prospective randomized trial to determine the~     effects of aerobic exercise training on ED among 50 sedentary men undergoing radical~     prostatectomy for clinically localized prostate cancer.~   "
205315|NCT00874133|"~     Diabetes affects 5.8% of the adult population in Israel (1). Gastroparesis is a syndrome~     characterized by delayed gastric emptying in the absence of mechanical obstruction of the~     stomach.Treatment with acupuncture has been described as effective in improvement of symptoms~     in patients with gastroparesis in a number of patient series. However, this treatment~     approach has not been tested by means of a controlled randomized clinical study, and neither~     has the connection between improvement of symptoms and the anatomical-physiological effect of~     the treatment, if ever, assessed.This study will test the efficacy of motilium (20 mg thrice~     daily) as compared to acupuncture treatment on the following subjective and objective~     parameters of 30 patients with diabetic gastroparesis and impaired glucose control:~        1. To compare the degree of GCSI scores improvement before and after treatment with~          motilium or acupuncture using a validated questionnaire.~        2. To determine the effect of treatment with motilium or acupuncture on gastric emptying~          rate.~        3. To determine the effect of treatment with motilium or acupuncture on glycemic control.~        4. To compare the quality of life before and after treatment with motilium or acupuncture~          using the Short Form-36 (SF-36).~   "
205316|NCT00874120|"~     Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized~     on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy~     with randomized active or placebo treatment with a subsequent 6-8 day washout period,~     followed by a second 7-day period of double-blind therapy with the other agent. Ambulatory~     blood pressure measurement will be performed beginning on Day 7 of each treatment period~     following administration of the study drug.~   "
205317|NCT00874107|"~     The Phase 2 study described in this protocol will serve to evaluate the antitumor activity,~     safety and pharmacokinetic profile of Imprime PGG when combined with bevacizumab and~     concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced~     NSCLC. Additionally, this study will provide guidance for the design of more definitive~     efficacy studies of Imprime PGG in NSCLC patients.~   "
205318|NCT00874094|"~     Platelets are a component of blood, which contain factors which can enhance wound healing.~     This study proposes to evaluate the clinical response of laugh lines treated with a~     concentrated preparation of the subject's own platelets injected into or under the skin by~     taking serial photographs of the subject's face over a 12 week period. Also, the same~     preparation will be injected into or under the skin of the arm near the elbows, and serial~     biopsies will be taken over a 12 week period.~   "
205319|NCT00874068|"~     The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant~     formula on bone strength parameters.~   "
205320|NCT00874055|"~     Participants will be matched with either their friend or an unfamiliar peer who is the same~     gender and about the same age. Participants will have 45 minutes of free-play in an~     experimental room where they will have free access to energy-dense and nutrient-dense foods~     and an assortment of games and puzzles.~      The investigators predict that participants eating with a friend will eat significantly more~     than participants eating with an unfamiliar peer. The investigators also predict that~     overweight participants eating with an overweight partner will eat significantly more than~     participants eating with a non overweight participant.~   "
205321|NCT00874042|"~     This is an open-label, dose-escalation/de-escalation study of ARQ 197 administered orally in~     combination with gemcitabine. The study is designed to determine the safety, tolerability and~     maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of ARQ 197 when administered~     in combination with gemcitabine to patients with advanced solid tumors.~   "
205322|NCT00874029|"~     The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency~     ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine~     fibroids.~   "
205323|NCT00874016|"~     Time to intubate, view to glottic opening and success rate are not different when Airtraq~     technique is used compared to standard direct laryngoscopy in children.~   "
205324|NCT00874003|"~     The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on~     alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind~     placebo controlled clinical trial with parallel group design(N=59).~   "
205325|NCT00873990|"~     The aim of the investigators study is to compare how two different bonding agents affects~     retention in a preventive dental procedure of pit and fissure sealant. This study will help~     in deciding whether the self etch bonding agent requiring less steps in completion is as~     effective as the total etch bonding agent requiring multiple steps in fissure sealant~     placement.~   "
205326|NCT00873977|"~     The purpose of this study is to compare the treatment adherence and effects in three~     modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea.~   "
205327|NCT00873964|"~     In the United States cardiovascular disease (CVD) accounts for 1 in every 2.8 deaths and is~     the leading cause of death among men and women 65 years or older (1). Studies have shown that~     the risk for cardiovascular disease is higher in individuals with the Metabolic Syndrome (2).~     Metabolic Syndrome (MBS) is defined by the Adult Treatment Panel III (ATP III) guidelines as~     a group of risk factors that includes 3 or more of the following: abdominal obesity,~     hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure,~     and high fasting glucose (3). These factors place individuals at increased risk for the~     development of both cardiovascular disease (CVD) and diabetes mellitus (3). It is commonly~     held that insulin resistance is the driving force for the development of the MBS.~      Although there is a significant increase in incidence of MBS in the elderly, there are few~     studies that specifically examined MBS in that population. The prevailing opinion is that the~     strikingly high prevalence of the MBS in the elderly is due to concurrent obesity - i.e., the~     population gains weight as it ages, and development of the MBS accompanies the weight gain.~      However, while it is true that becoming obese may decrease insulin sensitivity, it has also~     been demonstrated that not all obese individuals are insulin resistant. Some studies suggest~     that up to 40% of obese individuals demonstrate normal insulin sensitivity (4). In addition,~     it is notable that the rate of increasing MBS in the population exceeds that of the rate of~     increasing BMI, suggesting that, while BMI may be a modulating factor, another factor~     independent of obesity also contributes to the development of MBS in the elderly.~      It is the investigators hypothesize that the MBS in the obese elderly population is primarily~     linked to insulin resistance and not to obesity per se. The investigators propose to test~     this hypothesis by assessing MBS and insulin resistance in a population of obese elderly men~     and women and then determining whether or not the MBS tracks with insulin resistance.~   "
205328|NCT00873951|"~     Hydrolysis of dietary protein may impact their gastrointestinal kinetics and further~     metabolism. The primary goal of this work was to measure the metabolic fate of intact or~     hydrolyzed protein using a protein of good nutritional quality, i.e., casein. A second aim of~     this study was to assess the true ileal digestibility of dietary protein using different~     methods including the hydrolyzed casein method and to measure its possible effect on~     endogenous intestinal N losses in humans.~   "
205329|NCT00873938|"~     With a change in malaria treatment policy to use combination antimalaria therapy, it is~     envisaged that compliance to combination therapy would be less than that of monotherapy that~     was being used for case management in Ghana. This is especially so as amodiaquine is~     unpopular because of its side-effects and the combination therapy is not a single formulation~     (fixed dose). Compliance may further be enhanced by community supervision through home visits~     of combination antimalarial therapy in cases of uncomplicated malaria.~      This study would assess compliance to Artesunate-Amodiaquine therapy. It would also assess~     the effect of compliance to artesunate-amodiaquine therapy on clinical and parasitological~     cure rates. This study targeting age groups above ten years, would complement a child~     artesunate -amodiaquine efficacy study being undertaken by the same investigators in children~     ten years and below at Kintampo District at the same time. The funding for the child study~     has been approved by the Gates Malaria Partnership. Findings from both studies, involving all~     age groups would be made available to the National Malaria Control Programme and other~     stakeholders as practical information that may be beneficial to implementing policy change~     process from antimalarial monotherapy to a combination therapy.~   "
205330|NCT00873925|"~     In this pilot study the investigators are trying to see if a single intravenous infusion of~     autologous (self) cord blood cells followed by 1 year of daily vitamin D and omega 3 fatty~     acid supplementation can preserve beta cell function (prolong honeymoon) in children with~     type 1 diabetes. All subjects will continue to use insulin therapy as needed to maintain the~     best possible glucose control.~      15 Subjects will be randomized such that 2 of every 3 (10 total) will receive cord blood plus~     vitamin D and Omega 3 while 1 of 3 (5 total) will serve as controls and will not receive cord~     blood, vitamin D, or Omega 3 supplementation.~      The study will involve 5 visits over 1 year to the University of Florida~      This study is a follow-up to our initial study of cord blood infusion alone in which 23~     children received autologous cord blood. The initial study was 100% safe but additional~     studies like the one described above are needed to determine how to improve cord blood based~     therapy.~   "
205331|NCT00873912|"~     This prospective annual release study was designed to assess the safety of a monovalent~     influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not~     previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy~     adults received a single dose of vaccine or placebo and were followed for 180 days.~   "
205332|NCT00873899|"~     The EVOLVO study is designed to compare the remote defibrillator management to the current~     standard of care, to assess its ability to treat and triage patients more effectively.~   "
205333|NCT00873886|"~     The primary research question of this study is: Does the pharmacokinetics of oseltamivir~     after a single oral dose differ between the pregnant and non-pregnant women?~   "
205334|NCT00873873|"~     Distinct patterns of loss in pulmonary function were identified in children with mild to~     moderate asthma participating in a 10-year observation period during the NHLBI Childhood~     Asthma Management Program. This loss in pulmonary function is likely related to ongoing~     inflammation unresponsive to current therapy. This study will measure indicators of airway~     inflammation which are associated with structural and physiologic changes in the lung and~     provide insight into mechanisms of asthma progression in adolescence and early adulthood.~   "
205335|NCT00873860|"~     This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to~     evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in~     adult subjects with uncontrolled, moderate-to-severe, persistent asthma.~   "
205336|NCT00873847|"~     This observational study tests the feasibility of enrolling subjects and obtaining an~     amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second~     aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks~     post-menstrual age. It will enroll 85-100 infants between 401-1,000 grams birth weight OR~     between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal~     Research Network sites.~   "
205337|NCT00873834|"~     This study is a comparative, double blind, placebo controlled trial of 6-months duration~     designed to evaluate 1) the effects of fluoxetine in 5 to 12 years old autistic children, 2)~     the effects of fluoxetine on serotoninergic parameters, 3) cerebral metabolic changes (rCBF~     measurements with PET) induced by the treatment.~   "
205338|NCT00873821|"~     A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo~     in subjects with type 2 diabetes who have inadequate control on metformin.~   "
205339|NCT00873808|"~     RATIONALE: Gathering information over time from imaging and laboratory tests of women~     receiving bisphosphonates for breast cancer may help doctors learn more about long-term bone~     quality and plan the best treatment. Tetracycline hydrochloride and demeclocycline~     hydrochloride can mark the new growth of the bone, so it may be seen better under a~     microscope.~      PURPOSE: This clinical trial is studying long-term bone quality in women with breast cancer~     enrolled on clinical trial SWOG-S0307.~   "
205340|NCT00873795|"~     FDA has accepted atypical antipsychotics of olanzapine and aripiprazole as the adjuvant~     medications for refractory major depression. But there is still no trial about atypical~     antipsychotics combined with antidepressant of SSRI used in fresh major depressive patients.~     This project aims to compare the efficacy and tolerability of sertraline with or without~     low-dosed aripiprazole added in fresh major depression.~   "
205341|NCT00873782|"~     Muscular dystrophies are inherited disorders in which the skeletal and heart muscles become~     progressively weaker, sometimes leading to permanent disability. Current treatments aim to~     control symptoms as much as possible, but there is no cure. Gene therapy, in which defective~     genes causing the disorder are corrected, is a potential treatment option and is in the~     process of being developed for muscular dystrophies. This study will determine the safety and~     feasibility of a particular delivery method for gene therapy that could be used in the future~     to treat people with muscular dystrophies. Only normal saline, and no active treatment, will~     be used in this study.~   "
205342|NCT00873769|"~     The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg~     Staccato Loxapine administered to smokers compared to nonsmokers.~   "
205343|NCT00873756|"~     This is a multicenter, open-label study enrolling a total of up to 23 patients.~   "
205565|NCT00870818|"~     The purpose of this study is to assess the long term safety and efficacy in subjects with~     Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).~   "
205351|NCT00873652|"~     The UK immunisation guidelines recommend that children immunised with an accelerated course~     of hepatitis B vaccine (i.e. vaccination at 0, 1, 2 and 12 months) receive an additional~     booster dose of vaccine in later childhood (usually at 3 1/2 years of age). The primary~     objective of this study is to to assess what proportion of these children have 'protective'~     concentrations (10mIU/ml) of hepatitis B specific antibodies before and after the booster~     dose of hepatitis B vaccine.~   "
205352|NCT00873639|"~     This trial is conducted in Europe. The aim of this observational study is to evaluate the~     blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin~     detemir) after switch from human insulins for treatment of type 1 diabetes under normal~     clinical practice conditions in Romania.~   "
205353|NCT00873626|"~     The purpose of this study is to compare the efficacy of 5 days versus 10 days treatment~     duration in uncomplicated acute pyelonephritis.~      Acute pyelonephritis is a common disease and the treatment duration is not found on~     scientific evidence. If a short treatment is equal to standard duration, it will possible to~     shortening antibiotherapy with ecologic and economic advantage.~   "
205354|NCT00873613|"~     The purpose of this study is to determine if non-dilated retinal photography in the emergency~     room improves the diagnosis of papilledema (optic nerve swelling) in patients with neurologic~     disease compared to direct ophthalmoscopy.~   "
205355|NCT00873600|"~     RATIONALE: Gathering health information from older patients undergoing chemotherapy may help~     doctors plan better treatment and improve the quality of life for these patients.~      PURPOSE: This randomized clinical trial is studying how well an outpatient health care~     program works for older patients receiving chemotherapy for newly diagnosed breast cancer or~     colon cancer.~   "
205356|NCT00873587|"~     There are two commonly used methods to remove chest tubes following thoracotomy. One is to~     remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and~     hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to~     blow out as much air as they can can and hold it). There has been considerable discussion~     among Thoracic surgeons that one of these two methods may decrease the risk of pneumothorax,~     the most common complication associated with chest tube removal. The investigators will~     compare the two methods, and also identify risk factors of developing pneumothorax during~     chest tube removal.~   "
205357|NCT00873574|"~     The main goal of the study is to progress in our understanding of the molecular basis of~     myeloproliferative disorders of the bone marrow (polycythemia vera, essential~     thrombocythemia, primary myelofibrosis). The study will focus on the genes encoding factors~     implicated in the JAK-STAT pathway which has an essential role in these diseases~   "
205358|NCT00873561|"~     This was a study designed to evaluate the efficacy of multiple doses of an investigational~     drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age)~     patients with new onset type 1 diabetes mellitus, on endogenous insulin production.~      A total of 188 patients were enrolled in the study. The study was divided into three periods:~     screening, treatment (comprising an induction phase and maintenance phase), and follow-up.~      NBI-6024 was generally well tolerated and exhibits a benign safety profile, as there were no~     significant safety issues with NBI-6024 treatment. In summary, NBI-6024 did not demonstrate~     statistically significant efficacy compared with placebo.~   "
205359|NCT00873548|"~     The primary objective of this prospective multicenter study is to assess any fracture~     fixation complication and revision rates during the clinical use of the Proximal Femoral Nail~     Antirotation Asia (PFNA Asia) for the treatment of unstable trochanteric fractures.~   "
205360|NCT00873535|"~     Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking.~     However, very little research has been conducted into the nature of this co-occurrence. Thus,~     the main aim of this study is to assess differences in alcohol and tobacco consumption and~     cue-induced craving in treatment-seeking smokers after two weeks treatment of varenicline.~      Hypotheses~        1. Two weeks of varenicline treatment will significantly decrease cue-induced tobacco~          craving compared to placebo (Due to the actions of varenicline on alpha-4-beta-2~          receptors and its downstream effect on dopamine release).~        2. Varenicline will decrease cue-induced alcohol craving compared to placebo.~        3. The impact of Varenicline on cue-induced alcohol craving will be greater in heavy~          drinkers compared to social drinkers.~   "
205361|NCT00873522|"~     1. BACKGROUND~           Pneumonia occurring outside of the hospital setting is regarded as community acquired~          pneumonia. However, pneumonia occurring in non-hospital long-term care facilities~          constituted a distinct type of pneumonia from CAP. Kollef et al has justified health~          care associated pneumonia (HCAP) as a new category of pneumonia [1]. The HCAP patients~          are associated with severe disease, higher mortality rate, and greater length of stay~          and increased cost [1]. HCAP are often at risk for multi-drug resistant bacterial~          pathogens such as Pseudomonas aeruginosa, extended-spectrum beta-lactamase Klebsiella~          pneumoniae, Acinetobacter baumannii, and methicillin-resistant S. aureus (MRSA) [2].~           Health care facilities have not been defined in Taiwan. Respiratory care ward (RCW) is a~          special unit to take care long-term ventilatory dependent patients in Taiwan. Some of~          the patients get pneumonia and are referred back to medical centers. Besides,~          community-acquired P. aeruginosa, Acinetobacter baumannii or MRSA have been reported~          [3-8]. Therefore, the core-organisms of HCAP in Taiwan might be multi-drug resistant and~          the causes of inadequate initial antibiotics treatment. The common pathogens were also~          unknown.~           Till now, there are no data about the pathogens of HCAP in Taiwan. We define the~          health-care facilities and initiate a retrospective study to characterize the~          microbiology and clinical outcome of Community acquired pneumonia and~          Health-Care-Associated pneumonia in Taiwan. Further analysis will perform to confirm the~          differences between CAP an HCAP in Taiwan.~        2. Objectives:~           I. To characterize CAP and HCAP i. Microbiological epidemiology ii. Disease severity:~          PSI iii. Outcome : length of stay, mortality , antimicrobial susceptibility and~          treatment outcomes II. To characterize HCAP from RCW i. Microbiological epidemiology ii.~          Disease severity: PSI iii. Outcome : length of stay, mortality~        3. Study design:~      This is a retrospective multi-center cohort study to characterize microbiology, and clinical~     outcomes in Taiwan.~      Data sources: CAP or HCAP registered in 4 medical centers from Jan 1 2007 to Dec. 31 2007. (2~     in north Taiwan, 1 in central Taiwan, 1 in south Taiwan) Expected case number: 800 HCAP and~     1800 CAP~   "
205362|NCT00873509|"~     The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core~     features of autism in autistic children aged 2-6 years as measured by the change from~     baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared~     to placebo at 6 months.~   "
205363|NCT00873496|"~     Chronic inflammation that comprises the exocrine glands' function leads to xerophthalmia and~     xerostomia in Sjögren's syndrome. The oral consequences range widely and they are related to~     decreased salivary output. Hydroxychloroquine may inhibit cholinesterase activity in salivary~     glands via interference with antigen processing mechanism, and thus, the investigators'~     hypothesis was that salivary gland function may be improved if treated with~     hydroxychloroquine. The effects of hydroxychloroquine on the salivary flow rate, subjective~     and objective parameters of the patients were also assessed.~   "
205364|NCT00873483|"~     Birth Control Patch Study~   "
205365|NCT00873470|"~     The study consists of the realization of a new esophageal stimulation for patients already~     stimulated 10 years ago.~      The investigators would like to make a long term evaluation of the evolution of anterograde~     effective refractory period of accessory duct in the WPW syndrome.~      This study will be realized by esophageal stimulation.~   "
205366|NCT00873457|"~     Perifosine inhibits the AKT pathway (a way cells communicate with each other). This pathway~     is felt to be important in the development of several types of cancers including chronic~     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is thought perifosine may~     be able to block this pathway and lead to an improvement in the CLL or SLL. The purpose of~     this trial is to see if perifosine is an effective treatment for relapsed or refractory CLL~     or SLL. Another purpose of this study is to look at the effect perifosine has on cells.~   "
205367|NCT00873444|"~     The purpose of this study is to monitor the performance and compare the metal ion release of~     two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients~     with hip joint disease requiring a total hip replacement. Patients who enter the study will~     be randomly allocated to one of the bearing combinations and will be evaluated at regular~     intervals using, patient, clinical and x-ray assessments. Patients will also have blood~     samples taken at regular intervals to allow the metal ion levels to be determined.~   "
205368|NCT00873431|"~     The main aim of this clinical study is to investigate the safety and tolerability of~     different dose strengths of IC47 up to 6 months after the first vaccination.~      A total of 32 healthy subjects (male or female) will participate in this clinical study. The~     subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47~     will be administered three times in intervals of 42 days each.~   "
205369|NCT00873418|"~     This study will evaluate whether heart failure patients receiving a 16 week telephone~     delivered, intervention using cognitive behavior therapy to facilitate self-management of~     heart failure will have better clinical outcomes than heart failure patients receiving a 16~     week heart failure education intervention via telephone.~   "
205370|NCT00873405|"~     Obesity is a multifactorial disease that affects millions of people worldwide. It is the main~     independent risk factor for developing type 2 diabetes mellitus (T2DM). Most patients with~     T2DM and glucose intolerance (GI) are overweight, a condition known as diabesity. In patients~     with the most severe form of obesity, i.e., morbid obesity, the likelihood of developing~     diseases associated with obesity is increased.~      The investigators currently know that bariatric surgery provides sustained weight loss and~     well-documented remission of T2DM. Patients who undergo bariatric surgery show long-term~     reduced mortality from coronary artery disease, cancer and diabetes; 136 lives are saved per~     10,000 surgical procedures performed. Bariatric surgery is a relatively safe procedure that~     is becoming increasingly well-accepted; in 2007, approximately 170,000 bariatric procedures~     were performed in the USA. Currently, bariatric surgery is the most effective choice of~     treatment of morbidly obese patients with diabetes.~      The surgical procedures that are currently performed to treat morbid obesity are divided into~     two main groups: gastric restrictive procedures and combination procedures; the latter~     combine gastric restriction and malabsorption. The roux-en-Y gastric bypass (RYGB) is the~     combination procedure most frequently performed, whereas sleeve gastrectomy (SG) is an~     emerging restrictive procedure. SG can be performed as the first of a two-stage operation in~     patients at high risk of death, or as a definitive surgical procedure. It has shown good~     results with regard to weight loss and glycemic control in various studies. The potential~     advantages of SG include lower probability of vitamin and mineral deficiencies because this~     procedure has no malabsorptive component; access to the entire intestinal tract; no need for~     a subcutaneous access port or adjustments; absence of dumping syndrome and lower probability~     of intestinal obstruction. In addition, SG can be performed in patients who have inflammatory~     bowel disease or who have undergone bowel surgery, and it can be easily converted into RYGB.~     Both SG and RYGB can be performed with or without the placement of a Silastic® ring.~      The metabolic control achieved with bariatric procedures has been demonstrated and reproduced~     in various medical centers worldwide. Metabolic control can be achieved with gastric~     restrictive procedures such as vertical banded gastroplasty, adjustable gastric banding and,~     more recently, SG. However, it has been shown that glucose homeostasis is affected by various~     intestinal mechanisms observed exclusively in procedures that include a malabsorptive~     element, such as RYGB.~      A systematic review of 22,094 cases of morbidly obese patients submitted to bariatric surgery~     has shown that resolution of T2DM was achieved in 76.8% of the cases, improvement being~     achieved in 86% of cases. Among the criteria used to diagnose metabolic syndrome, fasting~     glucose levels are the first to return to normal in patients submitted to Silastic® ring~     gastric bypass (SRGB), a modification of the traditional RYGB which consists in adding a~     Silastic® ring to the gastric bypass operation. Normoglycemia after bariatric procedures, as~     well as diabesity itself, is multifactorial. Normoglycemia is observed as a result of dietary~     control, decreased plasma levels of ghrelin, weight loss and reduction of body fat, as well~     as of the release of gastrointestinal hormones that interfere with the function of pancreatic~     β cells (incretins).~      The main purpose of this study was to compare the weight loss of morbidly obese patients~     submitted to either a Silastic® ring sleeve gastrectomy (SRSG) or an SRGB, as well as to~     compare the effects of both procedures on glucose homeostasis in morbidly obese patients.~   "
205371|NCT00873392|"~     Medical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs,~     with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of~     nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among~     Parkinsonian patients. However, controlled studies provided conflicting results. One of our~     patients showed a substantial decrease of his parkinsonian symptoms under transdermal~     nicotine-therapy. Currently, this patient has been treated since 8 years with an excellent~     safety, especially on cardiovascular level. Otherwise, the investigators performed an open~     pilot safety and feasibility study in 6 patients, which demonstrated the possibility of a~     controlled study. In this study, all patients received daily doses during several months~     until 105 mg/day and could, in parallel, decrease their L-Dopa and agonists doses, improving~     their motor scores.~      The investigators now propose a phase II, controlled, single blind and randomised efficacy~     study (n=40) in 2 parallel groups. (1 group transdermal nicotine-therapy / 1 control group~     without additional therapy) The main objective is to verify the correlation between UPDRS~     (score III) motor score and the administrated nicotine dose. This study will also allow the~     evaluation of nicotine neuroprotective effect. The incrementation phase by weekly steps of 5~     mg until 20 mg, then 10 mg to reach 90 mg/j or the maximal tolerated dose, will last on 11~     weeks and will be followed by a 28 weeks phase at this stable dose. After this maximal dose~     plateau phase, treatment will be progressively decreased by 15 mg weekly steps, over a de~     6-week period followed by a five-week wash out phase.~      Taking into account results from the pilot study, a long-term high doses treatment, seems to~     be liable to improve patients who deeply suffer from their disease. This is why the~     investigators now propose this monocentric institutional project.~   "
205372|NCT00873379|"~     122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a~     night of melatonin, half got a placebo.~   "
205373|NCT00873366|"~     RATIONALE: A breath test that measures enzymes may be effective in identifying women in whom~     tamoxifen may not be effective.~      PURPOSE: This clinical trial is studying a breath test to see how well it works in women~     receiving tamoxifen for the prevention or treatment of breast cancer.~   "
205374|NCT00873353|"~     The purpose of this study is to determine efficacy of the treatment with erlotinib in~     combination with capecitabine in patients with advanced pancreatic cancer.~   "
205375|NCT00873340|"~     To gather Observation data about physical disability progression, safety and adherence during~     the use of Betaferon in daily practice. Patients with any type of Multiple Sclerosis (MS)~     (MRRS) (PSMS), under treatment with Betaferon.Open Multicentric Observational study.24~     months.Evaluation of physical disability in patients treated with Betaferon, using Kurtzke's~     expanded disability scale (EDSS) in biannual periods~   "
205376|NCT00873327|"~     This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety~     of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be~     four cohorts of 8 infants each:~        1. < 32 weeks gestational age (GA) and < 14 days postnatal age (PNA)~        2. < 32 weeks gestational age and >=14 days postnatal age~        3. >=32 weeks gestational age and < 14 days postnatal age~        4. >=32 weeks gestational age and >=14 days postnatal age. The study requires~          administration of 6 doses of study drug along with other antimicrobials per standard of~          care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at~          steady state. The risks are reasonable vs. the benefits and have been minimized~          appropriately. There may be benefit to the subjects (administration of broad spectrum~          empirical antimicrobial therapy), and information from the study may benefit a large~          number of other infants in whom the drug is currently being administered despite the~          lack of PK data in this population.~   "
205377|NCT00873314|"~     The aim of the pilot trial is to assess at what extend women with arrested threatened preterm~     labor change their activity patterns at home in response to bed rest prescription.~      An area of concern for the design of a trial is the strength of health provider's~     recommendation to change women's behaviors, and their compliance with bed rest~     recommendations. The study was a randomized parallel design. The intervention group consisted~     of total bed rest for four days (with allowance to go to the toilet). The control group~     consisted in the restriction of activities during four days.~   "
205378|NCT00873301|"~     Women with vulvodynia will fill out a questionnaire and undergo a gynecological examination~     before and 6 months after vestibulectomy. The investigators hypothesize that pain will~     decrease.~   "
205439|NCT00872482|"~     This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain~     radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases~     from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy~     of nimotuzumab in combination with WBRT.~   "
205379|NCT00873288|"~     RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer~     Information Service may be more effective than a standard reminder letter in helping patients~     who have had an abnormal Pap test keep their follow-up colposcopy appointment.~      PURPOSE: This randomized clinical trial is studying a personalized letter with Cancer~     Information Service support to see how well it works compared with a standard reminder letter~     in women scheduled for colposcopy after an abnormal Pap test.~   "
205380|NCT00873275|"~     RATIONALE: Drugs used in chemotherapy, such as ursodiol, oxaliplatin, leucovorin, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the~     tumor. Giving ursodiol together with leucovorin calcium, fluorouracil, oxaliplatin, and~     bevacizumab may be an effective treatment for colorectal cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of ursodiol when given~     together with combination chemotherapy and bevacizumab in treating patients with stage IV~     colorectal cancer.~   "
205381|NCT00873262|"~     The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex~     hormones, among women suffering from severe PreMenstrual Syndrome (PMS) and desensitizes them~     with the relevant sex hormones in order to reduce PMS symptoms.~      The system includes skin testing panel for identification of hormones to which the patients~     might be sensitive. Tests are applied close to the ovulation period and the skin reaction is~     examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests~     and patient's history will determine the eligibility of the patients to enter a~     desensitization protocol.~      During the desensitization period hormones to which the patient were found sensitive to, are~     injected intradermally three times (once a month) within the luteal phase in increasing~     doses. The end-point of the study is a statistically significant decrease, or elimination of~     PMS symptoms, compared to a solvent group.~   "
205382|NCT00873249|"~     This study is a 6-month, multicenter, randomized study to assess the effect of daily SMS~     reminders sent during 3 months in the adherence to oral antipsychotic treatment in stabilized~     outpatients with schizophrenia.~   "
205383|NCT00873236|"~     RATIONALE: Comparing results of MRI scans done after bevacizumab may help doctors predict a~     patient's response to treatment and help plan the best treatment. It is not yet known whether~     giving bevacizumab alone is more effective than giving bevacizumab together with interferon~     alpha-2a in detecting kidney cancer.~      PURPOSE: This randomized phase II trial is studying MRI scans of blood vessel changes caused~     by bevacizumab to see how well it works compared with bevacizumab given together with~     interferon alpha-2a in treating patients with stage III or stage IV kidney cancer.~   "
205384|NCT00873223|"~     This trial is conducted in the United States. The aim of this clinical trial is to~     investigate whether chronic liraglutide administration affects the mode of action~     (pharmacokinetics) of insulin detemir~   "
205385|NCT00873210|"~     Objective of this study is to increase knowledge about safety, tolerability, quality of life~     and efficacy under conditions of routine use of sunitinib.~   "
205386|NCT00873197|"~     This study has been designed to investigate the pharmacokinetic and safety profile of the~     co-administration of intravenous (IV) and transdermal granisetron, as well as characterise~     the pharmacokinetics of multiple transdermal dosing.~   "
205387|NCT00873184|"~     The purpose of this study is~        -  to assess the feasibility and acceptability of massage therapyto examine the effects of~          massage therapy~        -  to explore whether psychological outcomes are associated with changes in patient~          reported QoL.~   "
205388|NCT00873171|"~     As a safe and noninvasive method of treatment, the intent of the study is to show that~     Osteopathic manipulation therapy is a beneficial treatment for the aggravating bladder~     symptoms seen in all patients with interstitial cystitis.~   "
205389|NCT00873158|"~     The purpose of this study is to compare two treatments for adhesive capsulitis.~   "
205390|NCT00873145|"~     Background:~      Bone defects of the distal humerus require complex reconstructions, for which standard~     prostheses may be insufficient. The researchers therefore investigated the clinical and~     radiological outcome of elbow reconstructions by megaprostheses.~   "
205391|NCT00873132|"~     Purpose and Objective:~      The purpose of this study is to collect data both retrospectively and prospectively, by~     consent, on subjects seen in the PRTBTC. This information will be useful to the investigators~     to generate hypotheses for planning further psychosocial and medication intervention studies~     that will hopefully improve primary brain tumor patients' QOL.~   "
205392|NCT00873119|"~     The purpose of this study is to assess efficacy and safety of belinostat in combination with~     carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown~     primary.~   "
205393|NCT00873106|"~     The purpose of the present study is to determine if the retinal thickness estimates of the~     Stratus OCT, the 3D OCT-1000, and the CirrusHD OCT are comparable in diabetic and in healthy~     individuals (OCT=Optical Coherence Tomography).~   "
205394|NCT00873093|"~     This pilot, phase II trial studies the side effects of giving bortezomib together with~     combination chemotherapy and to see how well it works in treating young patients with~     relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving bortezomib together with combination~     chemotherapy may kill more cancer cells.~   "
205395|NCT00873080|"~     The present study aims to verify the reliability of intra and inter-examiner of angular~     measures proposed by SAPO postural assessment software. Methods: 24 subjects were~     photographed and three experienced examiners analyzed the images.~   "
205396|NCT00873067|"~     The aim of this study is to evaluate whether performing complex fractionated atrial~     electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.~   "
205397|NCT00873054|"~     The investigators main hypothesis is that the stone free rate will be much higher (95%) in~     patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to~     determine which treatment is safe and prevent less stone recurrence.~   "
205398|NCT00873041|"~     CICL670A2209: This study will evaluate the safety and efficacy of deferasirox in~     non-transfusion dependent thalassemia patients with iron overload. Patients will be treated~     either with active treatment (deferasirox) or placebo for 12 months (core study phase).~     Patients who complete the core study phase will be offered to continue their study with the~     active treatment (deferasirox) in a 12 months extension phase. During the core and extension,~     the effects of treatment on iron overload in the liver will be evaluated using magnetic~     resonance imaging (MRI) assessments.~      CICL670A2209E1: A one-year open-label extension to a randomized, double-blind,~     placebo-controlled, phase II study to evaluate efficacy and safety of deferasirox in~     non-transfusion dependent thalassemia patients with iron overload (Thalassa).~   "
205399|NCT00873028|"~     The purpose of this study is to evaluate the effects of a 6-day postoperative in hospital~     cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential~     association with improved functional capacity after coronary artery bypass grafting surgery.~   "
205400|NCT00873015|"~     The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and~     to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured~     cerebral aneurysms.~   "
205401|NCT00873002|"~     RATIONALE: Panobinostat and sorafenib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Sorafenib may also stop the growth of liver cancer by~     blocking blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when~     given together with sorafenib in treating patients with liver cancer that is metastatic~     and/or cannot be removed by surgery.~   "
205402|NCT00872989|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more~     effective when given alone or together with vandetanib.~      PURPOSE: This randomized phase II trial is studying docetaxel given together with or without~     vandetanib to see how well it works in treating patients with persistent or recurrent ovarian~     epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.~   "
205403|NCT00872976|"~     The purpose of this study is to determine the recommended dose for the combination of~     dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).~   "
205404|NCT00872963|"~     Malaria is one of the leading causes of deaths in children below five years old. Despite~     antimalarial drugs and insecticide treated bed nets, the established means of treatment and~     protection, malaria still continues to affect many children. A malaria vaccine would be a~     very effective way of reducing malaria infection in the community. RTS,S/AS01E is a leading~     malaria vaccine candidate which is being developed for children in Africa. The investigators~     have done a study to find out if this vaccine is effective in reducing infection by malaria~     in children aged 5-17 months living in Kenya and Tanzania. The follow up of the original~     study was 14-18 months. The extended follow up is proposed to continue for another four~     years.~   "
205405|NCT00872950|"~     The purpose of this study is to determine the effectiveness and adverse effects of~     3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS) and~     Congenital Myasthenic Syndromes (CMS).~   "
205406|NCT00872937|"~     Human papillomavirus (HPV) infection plays a key role in the carcinogenesis of cervical~     cancer and pre-invasive lesions. There are hundred types of HPV, including high risk and low~     risk types, and it is proved the close association between the cervical cancer and high risk~     HPV. While HPV 16 and 18 are known to be the leading two genotypes detected in women with~     cervical neoplasm worldwide, there is considerable difference in the other prevalent high~     risk genotypes in different geographic areas. It is important to establish the local database~     about the cervical intraepithelial lesions and the related prevalent HPV genotypes. The~     investigators designed a retrospective study which included total 784 patients managed at our~     hospital from January 1, 2000 to December 31, 2007. The present study was to investigate the~     HPV genotypes in the Taiwanese female patients with abnormal cervical cytology and analyses~     the association between HPV types and cervical pre-invasive lesions. It could provide the~     guide for the clinicians in the management of patients with abnormal cytological change of~     Pap smear.~   "
205407|NCT00872924|"~     An open label, bioequivalence study of sumatriptan succinate 100 mg tablets (containing 140~     mg of sumatriptan succinate equivalent to 100 mg sumatriptan) under fasting Conditions~   "
205408|NCT00872911|"~     The investigators' general hypothesis is that nutritional factors, including protein/energy~     malnutrition and/or an impaired response of muscle to nutrition, and inactivity play~     significant roles in developing sarcopenia, the involuntary loss of muscle mass and function~     with age. Therefore, age-specific prolonged interventions including nutritional manipulations~     and/or exercise may help to reduce, stabilize, or even reverse sarcopenia.~   "
205409|NCT00872898|"~     The purpose of this study is to investigate the safety and efficacy of memantine extended~     release, as well as its extent of absorption in pediatric patients with autism.~   "
205410|NCT00872885|"~     The purpose of the trial is to determine whether the new centrally acting analgesic is~     effective in comparison to placebo and an active comparator (morphine).~   "
205411|NCT00872872|"~     Three-drug combination of antiretroviral regimens has been used increasingly in HIV-infected~     pregnant women worldwide, both for the prevention of mother to child transmission of HIV~     (PMTCT) and for women's own health. Use of these drugs in pregnant women solely for PMTCT~     means that these drugs will need to be discontinued in the majority of women after delivery.~      Certain antiretroviral regimens contain drugs with long half-life (drugs that stay in the~     body for a longer period of time after discontinuation than other drugs in the same regimen),~     such as nevirapine (NVP). HIV can easily develop resistance to NVP when NVP is the only drug~     left in the body (similar to monotherapy). Given two other drugs for up to 1 week after~     discontinue NVP (to mimic three-drug regimen while waiting for NVP elimination) can help~     reduce, but not eliminate, the development of resistant virus.~      Unfortunately, NVP-containing regimens are the most widely used regimens for pregnant women~     in developing countries due to its low cost and its availability in fixed-dose combinations.~     These study will explore how fast NVP is eliminated from women after delivery and to see if~     given zidovudine/lamivudine (AZT/3TC) for 1 or 2 weeks after NVP discontinuation can help~     reduce the development of NVP resistant virus.~   "
205412|NCT00872859|"~     Primary Hypothesis:~      1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast~     reconstruction~      Secondary hypotheses:~        1. The complication rates following staged breast reconstruction using Alloderm or~          Dermamatrix are higher if the patient requires radiation compared to those who do not~          require radiation.~        2. Dermal matrix incorporation is not altered in patients requiring radiation compared to~          those who do not require radiation.~        3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix~      Specific aims:~        1. Evaluate the complication rates in women undergoing staged breast reconstruction with~          acellular dermal matrix with or without radiation~        2. Compare the complication rates between the two types of acellular dermal matrix~        3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation~          compared to that not exposed to radiation.~        4. Compare the rates of incorporation of the dermal substance into surrounding tissues of~          those patients undergoing radiation to those not undergoing radiation~   "
205413|NCT00872846|"~     To evaluate the safety and performance of the BALANCE System in treating patients who have~     type 2 diabetes and are overweight. Impact on blood glucose levels, weight loss, blood~     pressure and other clinical and metabolic parameters will be studied.~   "
205414|NCT00872833|"~     Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Regular~     blood transfusions, which refresh the healthy red blood cell supply, are one treatment for~     thalassemia. People with thalassemia often experience pain, but the exact source of pain~     remains unknown. This study will examine how pain varies during the blood transfusion cycle~     in people with thalassemia who are treated with regular blood transfusions.~   "
205415|NCT00872820|"~     This study will compare the effects that two types of behavioral therapy have on brain~     function in people with social anxiety disorder.~   "
205416|NCT00872807|"~     The purpose of this study is to evaluate the effectiveness of a life style counseling~     programme designed for overweight and obese children and their parents in groups compared to~     traditional individual counseling in the pediatric outpatient clinic and the community. The~     two interventions are both hospital and community based.~   "
205417|NCT00872794|"~     The purpose of this study is to monitor the performance and determine the metal ion release~     of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip~     resurfacing surgery. Patients who enter the study will be evaluated at regular intervals~     following hip surgery using patient, clinical and x-ray assessments. A subset of patients~     will also have blood samples taken at regular intervals to allow the metal ion levels to be~     determined and undergo scans to allow the bone mineral density of the bone surrounding the~     implant to be monitored.~      DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from~     November 2010 to allow for the completion of the 5 year follow up assessments.~      Please note that subsequent to this decision DePuy voluntarily recalled the ASR products on~     24 August 2010. Additional information regarding this voluntary recall and the follow-up of~     patients affected by the recall can be found at the following links~     http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157 and~     http://www.depuy.com/countries_list.~   "
205418|NCT00872781|"~     The study was conducted as a open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioavailability study comparing Quinapril hydrochloride~     and Hydrochlorothiazide tablets 20 mg/25 mg of OHM Laboratories Inc (a subsidiary of Ranbaxy~     pharmaceuticals Inc) with AccureticTM tablets 20 mg/ 25 mg (containing quinapril~     hydrochloride 20 mg and hydrochlorothiazide 25 mg) manufactured by Parke Davis~     Pharmaceuticals Limited, Vega Baja, PR 00694, Made in Germany and distributed by Parke-Davis,~     Division of Pfizer Inc. NY, NY 10017 in healthy, adult, male, human subjects under fasting~     condition.~   "
205419|NCT00872755|"~     Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the~     surgical management of the majority of patients suffering from gastroesophageal reflux~     disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the~     immediate postoperative period. This randomized controlled study was scheduled to investigate~     the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication,~     in prevention of paraesophageal herniation and improvement of postoperative results, in~     surgical treatment of GERD.~   "
205420|NCT00872742|"~     This study will test the effectiveness of a new behavioral therapy for adults with~     trichotillomania (compulsive hair pulling).~   "
205421|NCT00872729|"~     Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as~     the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate)~     which must be taken every six hours for the rest of the patient's life to prevent~     complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being~     studied to see if it may be able to be given less frequently, once every 12 hours, and have~     similar results.~   "
205422|NCT00872716|"~     The study hypothesis is that quetiapine XR has anxiolytic properties. The study aims to~     investigate the putative anxiolytic properties of quetiapine XR in patients with anxiety~     disorders. Therefore, in a proof-of-concept design patients with simple phobia will be~     selected to investigate specific anxiolytic and antipanic activity during acute anxiety.~     Moreover, in a combined fMRI/visual stimulus presentation paradigm activity of fear-network~     associated brain structures such as the amygdala will be investigated under treatment with~     quetiapine XR or placebo. Additionally, genetic factors potentially mediating anxiolytic~     properties of quetiapine will be studied.~   "
205435|NCT00872547|"~     The purpose of this study is to monitor the performance of a large metal-on-metal bearing~     from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip~     resurfacing surgery or a total hip replacement. Patients who enter the study will be~     evaluated at regular intervals following hip surgery using patient, clinical and x-ray~     assessments.~      The Study was terminated with effect from 30th November 2011 following the completion of 2~     year follow up assessments for those patients remaining in the study.~      Please note that prior to this decision DePuy voluntarily recalled the ASR products on 24~     August 2010. Additional information regarding this voluntary recall and the follow-up of~     patients affected by the recall can be found at the following links~     http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON155761 and~     http://www.depuy.com/countries_list.~   "
205423|NCT00872703|"~     Cytomegalovirus (CMV) is the largest member of the virus family Herpesviridae that infects~     almost all humans at some point in their lives (Ross, 2004). Congenital CMV infection is most~     likely to occur when the mother experiences a primary infection during pregnancy, and it is~     much less common in cases of reactivation of the disease or infection by a different CMV~     strain (Boppana 1999, Endres 2001). The prevalence of congenital CMV infection varies between~     0.15-2.2% (Ross 2004, Ross 2006, Malm 2007). While most infants born with congenital CMV~     infection are asymptomatic, 10 to 15% show clinical findings at birth (Ross 2004).~      It is generally agreed that congenital CMV infection, whether it is symptomatic or not, is a~     major risk factor for perceptual deficits. However, its influence on children's future~     neuropsychological functioning is less well established. Symptomatic congenital CMV infection~     is a major risk factor for poor developmental outcome (Williamson 1982, Kylat 2006, Dollard~     2007), but the available data regarding neuropsychological outcome for asymptomatic children~     is extremely diverse (Conboy 1986, Ivarson 1997, Kashdan 1998, Temple 2000, Zhang 2007).~      We evaluated the neuropsychological outcome of children with congenital cytomegalovirus (CMV)~     infection and normal consecutive fetal neurosonographic examinations and determined whether~     Magnetic Resonance Imaging (MRI) provided additional information in these cases.~   "
205424|NCT00872690|"~     The goal of this study is to examine things that make it easy or hard for OEF/OIF veterans~     with polytrauma to live independently or do things on their own at home and in the~     community.~   "
205425|NCT00872677|"~     RATIONALE: A culturally sensitive weight loss program for obese African American breast~     cancer survivors may be more effective than a standard weight loss program in helping women~     lose weight.~      PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to~     see how well it works in African American women who are breast cancer survivors.~   "
205426|NCT00872664|"~     The primary objectives of this study are to compare the serum and skin concentrations of~     beta-carotene, lutein, and lycopene in preterm infants fed preterm formulas with mixed~     carotenoids to serum concentrations in preterm infants fed preterm formulas with no added~     carotenoids and to human milk fed infants.~      The secondary objective of this study is to evaluate the effects of dietary carotenoids on~     the developing eye. Stages and zones of retinopathy of prematurity (ROP), retinal function,~     and retinal characteristics will also be examined.~   "
205427|NCT00872651|"~     Eligible patients will be randomized in a 1.1 ratio to receive Travoprost 0.004%/timolol 0.5%~     once daily or Latanoprost 0.005%/Timolol 0.5% once a day for 8 Weeks. The study treatments~     will be compared for mean diurnal intraocular pressure (IOP) change from baseline at Week 8.~      Safety parameters measured at 4 study visits: ocular signs, visual acuity, dilated fundus,~     cardiovascular parameters (blood pressure and pulse), and adverse events.~   "
205428|NCT00872638|"~     Aesthetic appearance of repaired incisions is very important to surgical patients. It has~     been stated that if the edges of a wound are closed in such a manner that will result in~     eversion, or pouting of the edges that the end cosmetic result will be superior when compared~     to wound edges that are simply approximated. The purpose of this study is to compare cosmetic~     outcomes of incisions that are closed with everted edges to those in which the edges are~     simply approximated.~   "
205429|NCT00872625|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy in higher doses over a shorter period of time may kill more tumor cells and have~     fewer side effects. Drugs used in chemotherapy, such as docetaxel, epirubicin,~     cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy~     when given together with docetaxel followed by standard therapy in treating women with breast~     cancer.~   "
205430|NCT00872612|"~     This randomized study investigates two different diagnostic strategies for patients with~     suspected pulmonary sarcoidosis stage I/II.~      The objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating~     non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB).~      Also the researchers investigate the additional value of BAL, in relation to endosonography~     and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis.~      Thirdly the researchers aim to assess the rate of complications in both the endosonography~     and conventional bronchoscopic workup.~   "
205431|NCT00872599|"~     The hypothesis is to test to see if the drug fenofibrate will increase important chemicals in~     the body and specifically in the kidney, help to rid the body of salt by the kidneys,~     decrease blood pressure and improve insulin sensitivity during high-salt intake in~     individuals with hypertension.~   "
205432|NCT00872586|"~     This study is designed to evaluate the additional efficacy and safety of olmesartan~     medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate~     essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil~     monotherapy~   "
205433|NCT00872573|"~     The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh~     bone when used in the treatment of patients with hip joint disease requiring a total hip~     replacement. Patients who enter the study will be evaluated at regular intervals following~     hip surgery using patient, clinical, standard x-ray assessments and special x-rays which~     allow the stability of the implant to be determined.~   "
205434|NCT00872560|"~     This trial is conducted in Europe. This trial aims to ensure that there is no substantial~     clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and~     NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.~   "
205436|NCT00872534|"~     To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by~     assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses~     of aspirin (325 mg) in normal healthy volunteers.~   "
205437|NCT00872521|"~     The purpose of this study is to determine efficacy of treatment with bortezomib (in~     combination with doxorubicin and dexamethasone) in previously untreated patients with~     Multiple Myeloma.~   "
205438|NCT00872495|"~     The purpose of this study is to determine if analysis of DNA and protein material found in~     urine will be useful in the detection of urothelial cancer of the bladder and kidney. This~     analysis may be helpful to determine if how a particular cancer will act regarding remission~     and recurrence~   "
205440|NCT00872469|"~     The WOMAN trial is a large pragmatic randomised double-blind, placebo controlled trial to~     quantify the effects of the early administration of tranexamic acid on death, hysterectomy~     and other relevant outcomes. 20,000 adult women, after delivery who have clinically diagnosed~     postpartum haemorrhage, are eligible if the responsible doctor is for any reason~     substantially uncertain whether or not to use an antifibrinolytic agent. Additionally, TWO~     nested studies will be conducted in a subset of women trial participants. The first nested~     study (ETAC) aims to evaluate the effect of tranexamic acid (TXA) on markers of coagulation~     in 400 women randomised to the WOMAN trial. The second nested study (ETAPLAT) aims to~     evaluate the haemostatic effect and antithrombotic effect of TXA in 128 women randomised to~     the WOMAN trial.~   "
205441|NCT00872456|"~     The ADHOC Cohort comprised 3044 DM individuals, treated in 47 CHS primary care clinics, that~     underwent haptoglobin genotyping between 2 march, 2005 and 26 September 2006. Individuals~     were eligible for inclusion if they had DM and were 55 years of age or older. All treatment~     decisions, regarding all aspects of care and follow-up of the study participants, remained at~     the discretion of the individual's primary care physician, who was blinded to the~     individual's Hp type. Hp distribution was: Hp 1-1 285 (9.4%); Hp 2-1 1248 (41.0%); Hp 2-2~     1511 (49.6%).~      Hypothesis: strict glucose control (HbA1c<7%) reduces the rate of cardiovascular events only~     to diabetic patients with the Hp 2-2 phenotype. We also postulated that, since Hp 2-2 DM~     individuals are at an increased genetic susceptibility for cardiovascular disease (CVD), this~     unique cohort merits an investigation on the associations between various CVD risk variables~     and CVD events and establish whether any evident association was dependent of the~     individual's Hp type.~   "
205442|NCT00872443|"~     Facing the lack of recommandations of Neurology and cardiology societies, the investigators~     decided in 2002 some Good Medical Practices to define a specific and precise population for~     whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current~     survey of these patients after implantation of a prothesis in interauricular septum is~     defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an~     echocardiography. One year after implantation, the investigators systematically realized a~     control by MRI associated to a contrast echography.~      In the aim of evaluating the investigators' medical practice, the investigators decided to do~     an observational study which will permit us to judge of the interest or lack of interest of~     our Good medical practice before the publication of prospective and randomised clinical~     studies.~   "
205443|NCT00872430|"~     The aim of this study is to evaluate the efficacy and safety of a phytotherapeutic laxative~     tea, composed by Pimpinella anisum, Foeniculum vulgare, Sambucus nigra and Cassia~     angustifolia, in a randomized crossover placebo-controlled clinical trial in patients with~     chronic constipation.~   "
205444|NCT00872417|"~     This study will recruit 520 treatment-naive and 150 treatment-experienced patients to take~     the first line or second line of antiviral therapy. This study aims to set up a well-trained~     clinical and laboratory team in China, to explore the effects and side-effects of the~     first-line and the second line of ARV treatment in Chinese HIV/AIDS adult patients, to~     investigate the side-effects of ARV drugs, such as hepatotoxicity, lipoatrophy,~     cardiovascular influence, to explore the pharmacokinetics/pharmacodynamics (PK/PD) of Chinese~     generic ARV regiments and effective drug concentrations and to explore primary and secondary~     drug resistance in China and the immune reconstitution characters of long term ARV in Chinese~     adult AIDS patients. This study might provide more practical and optimizing prove for the~     treatment guideline for resource limited areas.~   "
205445|NCT00872404|"~     This is an open-label phase II, multicenter study. Eligible patients will receive CP-751,871~     in monotherapy (20 mg/kg IV infusion on Day 1 of 3-week cycles). Tumor check-up will be~     performed every 6-8 weeks. Treatment will be continued until disease progression or~     unacceptable toxicities according to the patient or the investigator.~   "
205446|NCT00872391|"~     The purpose of this study is to assess the safety and efficacy of hypofractionated~     stereotactic LINAC radiotherapy with 10 fractions at 6 Gy per fraction at the 80% isodose for~     the planning target volume (PTV) in patients with uveal melanoma. Patients will be~     followed-up for 10 years after radiotherapy regarding local tumor control, visual acuity,~     secondary complications and survival.~   "
205447|NCT00872378|"~     The purpose of this study is to describe change in body weight in non-diabetic morbidly obese~     patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide or~     placebo injections.~   "
205448|NCT00872365|"~     At the moment, most of efforts to prevent non-transmissible chronic diseases at population~     level have been centered in promoting healthful behaviors like physical activity, consumption~     of fruits and vegetables, and discouraging from the consumption of tobacco and alcohol in~     adult population, but the results have been little hopeful. In the last years, manifold~     studies have indicated the relation between metabolic alterations and of the fetal growth~     with the development of non-transmissible chronic diseases in adult age. More recently, it~     has been proposed that maternal factors (endothelial function, oxidative stress and~     alterations in adipokines) and placental ones (mitochondrial dysfunction) are the precursory~     mechanisms of fetal metabolic alterations and of the later development of non-transmissible~     chronic diseases. Also, it has been suggested that possibly supplementation with~     micronutrients and the physical exercise during the gestation can regulate these maternal and~     placental factors. For the reasons just mentioned, it is necessary to clarify if these~     proposed factors are related to fetal metabolic alterations and if the supplementation during~     the gestation with micronutrients and/or the physical exercise can regulate them, which would~     be an early and novel alternative to fortify the prevention of non-transmissible chronic~     diseases in the population.~      Purpose~        1. To evaluate the effect of associated both the maternal and placental metabolic factors~          to non-transmissible chronic diseases in newborn.~        2. To evaluate the effect of the physical exercise and the complementation with~          micronutrients during the pregnancy either in the endothelial function, the levels of~          adipokines, the oxidative stress of the mother and the newborn, as in the placental~          mitochondrial function and the anthropometry of newborn.~   "
205449|NCT00872352|"~     In the present study we are planning to study electrophysiological changes related to the~     dose and time of bortezomib administration in newly diagnosed patients with MM, during the~     first months of treatment and 6 months after ending. In addition a possible correlation~     between the incidence of BIPN and the subtype of myeloma and other risk factors will be~     investigated.~   "
205450|NCT00872339|"~     Thalassemia is an inherited blood disorder that can result in mild to severe anemia. People~     with thalassemia often experience pain, but the exact sources and prevalence of pain remain~     unknown. This study will examine the prevalence and severity of pain in people with~     thalassemia who are treated with regular blood transfusions and people with thalassemia who~     are not treated with regular blood transfusions.~   "
205451|NCT00872326|"~     The aim of this study is to assess the efficacy and safety of autologous transplantation of~     bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with~     non-revascularizable critical limb ischemia.~   "
205452|NCT00872313|"~     A range of psychological disorders occur in women in the postpartum period. These include~     the blues, which occurs in the first days after birth and which is very common and~     self-limiting; severe psychoses often associated with mania or bipolar illness, occurring in~     the first weeks after birth; and mild to moderate depression, occurring weeks to months after~     birth. Studies have been done focused on postpartum psychosis using a retrospective~     investigation, which gave only a limited material on the prevalence of psychological~     disorders in postpartum women. The investigators hypothesized that different pathways to~     psychosis function as the risk factors which may be overlapped, truly independent, mediating,~     or moderating, in new mothers who are at high risk and/or during the early period of~     delivery. In addition, the investigators purposed that the temporal sequence of biological,~     social and demographic variables are also the potential factors contributing to the~     development of postpartum psychosis.~   "
205453|NCT00872300|"~     The purpose of this study is to determine the antitumor activity of PHA-739358 as single~     agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2~     previous lines of treatment for the disease.~   "
205454|NCT00872287|"~     The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new~     techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision~     Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but~     there are not any publications to study a possible different pain score in new techniques~     versus classic laparoscopic cholecystectomy. In this randomized controlled study the~     researchers have investigated the pain scores, the incidence of nausea and vomiting and~     analgesics request after the procedure.~   "
205455|NCT00872274|"~     To access the single-dose oral bioequivalence of sumatriptan succinate 100 mg tablet~     (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of OHM~     Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceutical Inc. USA) with IMITREX® 100 mg~     tablet (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of~     GlaxoSmithKline in healthy, adult, male, human subjects under fed condition.~   "
205456|NCT00872261|"~     This study will examine characteristics and behaviors of young women in India and Tanzania to~     determine which challenges and opportunities exist for conducting future trials of HIV~     prevention treatments.~   "
205457|NCT00872248|"~     The restless leg syndromes is a common sensorimotor disorder of unknown cause affecting~     approximately 10% of the population. Different literature had different views on the~     association between neuraxial anesthesia and the occurrence of restless leg syndrome. Some~     reported that spinal anesthesia induced postoperative restless leg syndrome, but other~     studies showed that spinal and general anesthesia all two did not cause restless leg~     syndrome. A potential difference amongst these studies is that a big difference exists in~     surgical types. The investigators proposed that different types of surgery performed~     undergoing various anesthesia, and that there is a big difference in original~     pathophysiological condition. Therefore, the investigators hypothesized that pregnant women~     who have special physical states would have had an association between neuraxial anesthesia~     and restless leg syndrome in such patients who received selective cesarean section undergoing~     spinal or epidural anesthesia.~   "
205458|NCT00872235|"~     This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single dose,~     crossover fully replicated study was conducted on fixed-dose combination of quinapril 20 mg~     and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc. (division of Ranbaxy~     Laboratories Limited) and Accuretic 20-25 mg tablets of Parke-Davis (division of Pfizer Inc.)~     in healthy, adult, human, male, subjects under fed conditions.~   "
205459|NCT00872222|"~     The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a~     ceramic-on-ceramic bearing combination in the treatment of patients with hip joint disease~     requiring a total hip replacement. Patients who enter the study will be evaluated at regular~     intervals following hip surgery using patient, clinical and x-ray assessments.~   "
205460|NCT00872209|"~     The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel~     medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.~      The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.~   "
205461|NCT00872196|"~     This is a follow-up study with no treatment and only samples being collected.~   "
205462|NCT00872183|"~     Background:~        -  Techniques that teach finger movements are commonly used to explore how humans learn to~          move. Researchers have designed a simple, new method of learning finger movements, which~          will be explored for the first time in this study. The method is based on how~          individuals mimic other people's movements.~        -  Previous studies have shown that a brain protein called brain-derived neurotrophic~          factor (BDNF) may be important in movement and in learning. There are normal variations~          in the gene for BDNF. As an optional component, this study will also look at whether~          these gene variations are associated with differences in movement learning.~      Objectives:~        -  To compare the new motor learning technique with a classic technique to test its~          usefulness.~        -  To examine whether genetic variations have an effect on motor learning.~      Eligibility:~        -  Healthy volunteers between the ages of 18 and 50, who are right-handed.~      Design:~        -  The study will involve two visits to the National Institutes of Health Clinical Center.~        -  Visit 1: Medical and neurologic examination to determine whether the volunteer is~          eligible to participate further in the study. This screening visit will take about 1~          hour.~        -  Visit 2: Volunteers will perform a motor learning task by interacting with a computer~          program. In response to images on the computer monitor, volunteers will press buttons on~          the keyboard as quickly and accurately as possible. The motor learning task will last up~          to 3 hours.~        -  If a volunteer agrees to genetic testing, researchers will also draw blood for study.~          Genetic testing is not required to participate in the motor learning parts of the study.~   "
205463|NCT00872170|"~     Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Many~     people with thalassemia also have pulmonary hypertension, which is high blood pressure in the~     arteries in the lungs. This study will evaluate the safety and effectiveness of the~     medication sildenafil at reducing blood pressure in the lungs of people with thalassemia and~     pulmonary hypertension.~   "
205464|NCT00872157|"~     The goal of this clinical research study is find the highest tolerable dose of BMTP-11 when~     given to patients with prostate cancer that has spread. The safety of this drug will also be~     studied.~   "
205465|NCT00872144|"~     Chemotherapy is often used to treat cancer and in many cases can cure it or extend life.~     Unfortunately many of the chemotherapeutic agents used in treating cancer can cause nerve~     damage, resulting in severe pain involving the extremities. This neuropathic pain causes~     significant suffering in cancer survivors and may also limit the amount of chemotherapy~     patients are able to tolerate in attempting to treat the cancer. There is evidence that~     cannabinoids can suppress chemotherapy evoked neuropathy in animal models, in some cases~     better than morphine. This study proposes to examine the effect of a cannabinoid extract~     (Sativex) in treatment of neuropathic pain caused by chemotherapy.~   "
205466|NCT00872131|"~     This study will attempt to identify gene and brain activity markers that predict whether~     people with social anxiety disorder will respond to selective serotonin reuptake inhibitor~     medications.~   "
205467|NCT00872118|"~     The purpose of this study is to develop and test a new brief intervention to reduce heavy~     drinking and social anxiety in college drinkers.~   "
205468|NCT00872105|"~     This is a multicentre randomized clinical trial prospectively comparing operative treatment~     versus conservative (nonoperative) care in the management of displaced distal (Type II)~     clavicle fractures.~   "
205469|NCT00872092|"~     Normally the gastrointestinal tract is only sparsely colonized with bacteria. The normal~     flora of the duodenal or jejunal aspirate contains no more than 10^5 bacteria per milliliter.~     Small bowel bacterial overgrowth (SBBO) is defined as a pathologically increased number of~     bacteria or the presence of colonic flora in the proximal intestine. The reasons for this~     condition are manifold, ranging from diabetic neuropathy to surgical bypass. SBBO is frequent~     in elderly people. Therapy is targeted at correcting the underlying small bowel abnormalities~     that predispose to the condition and at providing appropriate antibiotic therapy. The~     symptoms and signs of SBBO can be reversed with this approach. However, in many patients the~     conditions predisposing to SBBO persist life-long, once present. This suggests that~     noninvasive, sensitive diagnostic tools with high specificity are required. Bacterial culture~     of upper intestinal content is considered the diagnostic gold standard. However, since~     endoscopic harvesting of duodenal or jejunal fluid is difficult and invasive, indirect tests~     such as breath tests have been advocated as diagnostic tools. Hydrogen breath tests are~     commonly employed since the substrates can be easily obtained and the measurement is simple.~     Hydrogen is formed when carbohydrates are fermented in the intestine. Breath hydrogen~     analysis allows a separation of metabolic activity of the intestinal flora from that of the~     host, since no known hydrogen production occurs in mammalian tissue. The hydrogen breath test~     most often used in routine clinical practice uses glucose. However, the utility of this test~     is mostly limited by its low sensitivity, because there are nonproducers in up to 25% of~     the subjects tested. The investigators have developed a stable isotope breath test using~     13C-labeled lactose-ureide. Glycosyl-ureides are condensation products of reducing sugars and~     urea in aqueous acid. Lactose-[13C]ureide has been used to investigate oro-caecal transit~     time because it resists digestion by small intestinal enzymes and is hydrolyzed by bacterial~     enzymes in the large intestine. A number of studies have described the use of this substrate~     in adults and children. The aim of the present study was to investigate the~     lactose-[13C]ureide breath test in subjects with suspected SBBO and to compare its results~     with the results of the glucose hydrogen breath test. Microbiological analyses of upper~     intestinal bacterial cultures were used as gold standard to identify SBBO.~   "
205470|NCT00872079|"~     This study will create a computer program that can be used to help dose a drug called~     warfarin for the prevention of blood clotting. The study will collected specific information~     about those patients receiving this drug and use that information to create a computer~     program that will predict the effects of the drug. With this prediction program in place, the~     investigators can perform a series of what if I gave this amount of drug simulations to~     determine the best dose of drug for that patient. Once the computer programs are developed,~     the investigators will test the program in patients that actually need this drug. They will~     also include genetic information into the prediction since it has been shown that this~     information can affect how well the drug works. Patients will have this genetic information~     determined during this study.~   "
205471|NCT00872066|"~     The purpose of this study is to monitor the performance of artificial hip joints implanted~     with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients~     with hip joint disease requiring a total hip replacement. Patients who enter the study will~     be randomly allocated to SmartSet® HV or SmartSet® GHV and will be evaluated at regular~     intervals following hip surgery using patient, clinical and x-ray assessments~   "
205472|NCT00872053|"~     The primary aim of this study is to:~        1. Collect pilot data on the effect of task-specific lower extremity training using the~          Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;~        2. Collect pilot data on the use of combination therapy on improving gait in subjects with~          MS. This therapy will use both Anklebot training and robot-assisted gait training.~      Hypothesis: Both trainings will result in improved walking performance, but the combination~     therapy will result in greater gains than ankle training alone.~   "
205473|NCT00872040|"~     Pregnancy and delivery have a major impact on couple's inter personal relationship. Different~     modes of delivery have different effect on pelvic floor function, and it is known that~     instrumental vaginal deliveries have the worse effect, though various common anatomical~     injuries have been described following vaginal delivery. Pelvic floor dysfunction has the~     potential to ameliorate sexual function, and the investigators hypothesis is that the impact~     of delivery on pelvic floor disorders following delivery will have a direct effect on sexual~     malfunction and interpersonal relationship. The purpose of this study is to evaluate the~     effect of delivery mode of primiparous women on inter couple relationship , their sexual~     function and the female pelvic floor activity. The couples will be followed from the second~     trimester of the pregnancy by validated specific questionnaires, assessing the couple's~     satisfaction of their marriage, intimacy in their relationship, their sexual behavior and~     pelvic floor function. After delivery, the parameters of the parturition will be recorded,~     and the couples will be interviewed 6 months following delivery. Apart from questionnaires,~     sample of the participated women will be assessed by ultrasound examination of the pelvic~     floor.~   "
205474|NCT00872027|"~     This study will determine the effectiveness of antidepressant medication in preventing~     depression and improving recovery in people who have been supported by mechanical ventilators~     in an intensive care unit (ICU).~   "
205475|NCT00872014|"~     The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is~     effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who~     have not received any prior systemic therapy except surgery or locoregional therapy.~      Disease status and disease progression will be assessed every 8 weeks. Subjects will remain~     on treatment until: progressive disease by RECIST criteria; clinical progression; death or~     loss to follow-up; or withdrawal of informed consent.~   "
205476|NCT00872001|"~     The purpose of this study is to determine whether acadesine is effective in reducing the~     cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG~     surgery.~   "
205477|NCT00871975|"~     The purpose of this evaluation is to validate the previous clinical study results using a~     Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS)~     testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS~     equipment.~      The hypothesis is that the Tetra-NIRS device, in the clinical environment, provides data to~     enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic~     procedure).~   "
205478|NCT00871962|"~     The purpose of this prospective cohort study is to determine factors involved in survival in~     new COPD patients treated by long-term oxygen therapy.~      Background: long-term oxygen therapy is indicated in patients with severe COPD. No studies~     have been performed in the past 20-25 years to examine the results of early clinical trials.~     Further studies are necessary to understand the utility of oxygen therapy in severe COPD.~   "
205479|NCT00871949|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.~   "
205480|NCT00871936|"~     The purpose of this study is to determine whether SLx-4090 in combination with metformin~     therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin~     therapy alone.~   "
205481|NCT00871923|"~     The goal of this clinical research study is to learn whether Tarceva (erlotinib~     hydrochloride), when given in addition to whole brain radiation therapy, is better to treat~     brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).~   "
205482|NCT00871910|"~     Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered~     dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour~     intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each~     3-week period is considered one treatment cycle. Part 3 of this trial will evaluate the~     effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of SCH~     727965 administered as a 2 hour IV infusion once every 3 weeks.~   "
205483|NCT00871897|"~     People with heart failure may experience problems with cognitive function, including memory~     and attention. Cardiac rehabilitation, which is an individualized program for heart failure~     patients that aims to improve their heart health, may also improve cognitive function. This~     study will examine the relationship between heart failure and cognitive function and how~     undergoing cardiac rehabilitation affects cognitive function in older adults with heart~     failure.~   "
205484|NCT00871884|"~     This study is designed to investigate factors that are associated with prolonged recovery~     from mild head injury. The investigators are particularly interested in defining the impact~     of anxiety related variables, such as health anxiety and anxiety sensitivity in the~     maintenance of symptoms.~      A further goal of the study is the evaluation of two treatment methods that have been~     proposed to be effective in reducing the impact of post concussion symptoms. The~     investigators hypothesize that a treatment which is directly focused on changing these~     anxiety related variables will be more effective than one that does not.~   "
205485|NCT00871871|"~     This study will measure and compare changes in insulin production and sensitivity using the~     hyperglycemic clamp technique in obese patients with impaired glucose tolerance and~     hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide~     (HCTZ).~   "
205486|NCT00871858|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.~     Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is~     not yet known whether anastrozole is more effective than fulvestrant before surgery and~     radiation therapy in treating patients with breast cancer.~      PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works~     compared with fulvestrant in treating postmenopausal patients with breast cancer.~   "
205487|NCT00871845|"~     The purpose of this study is to determine whether obese people do not respond to hepatitis C~     treatment as well as lean people. This research studies whether obese people will show higher~     sustained virologic response rate if they lose weight by Orlistat use and dietary and~     lifestyle modification.~   "
205488|NCT00871832|"~     It is currently standard of care in many Medical and Surgical ICU's to institute a nurse~     driven insulin protocol in maintaining tight glucose control in the critical patient. Many~     articles have been written to address this topic. However, there is no current data regarding~     the use of glycohemoglobin as a marker of risk of morbidity and mortality. In our study we~     would like to determine whether or not the HbA1C could be used as a marker of morbidity and~     mortality. The HbA1C is a simple blood test that may be added on to any CBC collection tube;~     a blood sample that critical patients have drawn up to several times a day. The investigators~     would analyze this information in respect to the rest of the clinical data collected~     regarding the patient's illness.~   "
205489|NCT00871819|"~     The objective of this study is to evaluate extent, location, and perception of paresthesia as~     a function of anode/cathode configuration.~   "
205490|NCT00871806|"~     The study will evaluate whether the blood concentrations of eletriptan administered using two~     test formulations of oral disintegrating tablets are comparable to those observed with the~     standard commercial tablet.~   "
205491|NCT00871793|"~     Supracondylar humerus fracture are common upper extremity injuries in children accounting for~     over 400 fractures per year and approximately 25% of all fractures treated at Seattle~     Children's Emergency Department. Most of these fractures are treated with splints and casts~     though more than one-third undergo surgical fixation followed by casting. Healing is usually~     complete after 3-4 weeks, when casts (and pins, if fixed operatively) are removed and motion~     begun. Though stiffness is often a problem after immobilization of adult elbow fractures,~     stiffness after pediatric elbow fractures is regarded as typically transient. This study~     addresses the question Does early motion of the arm with physiotherapy promote the return of~     function and motion in patients with supracondylar humerus fractures? The investigators will~     conduct a prospective randomized trial to determine the effect of six occupational therapy~     visits over a five week period of time on elbow function and mobility after supracondylar~     humerus fracture. The investigators will measure motion of the elbow and administer the child~     and parental Activity Scale for Kids performance versions (ASKp) assessment tool to answer~     this question.~   "
218616|NCT00697528|"~     Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation~     forms and stages, made with Color Doppler Imaging~   "
205492|NCT00871780|"~     The primary objective of the study is to evaluate the evolution of walking capacity as~     measured by the timed 100-meter walk test (T100T), timed 25-foot walk test (T25FW), maximum~     walking distance (MWD), and Expanded Disability Status Scale (EDSS) during the first year of~     therapy with natalizumab. The secondary objectives of this study are as follows:~        -  To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T~          and the T25FW at Baseline, at Week 24 and at Week 48 of therapy.~        -  To determine how well each of the walking tests, T100T or T25FW, predicts walking~          limitations in all participants and in the subgroups of participants stratified by~          baseline EDSS.~   "
205493|NCT00871767|"~     The aim of this study is to compare the blood levels achieved with a new formulation of~     AZD5672 to an existing formulation of AZD5672 used in previous studies~   "
205494|NCT00871754|"~     This is a laboratory study where the investigators hope to look at chromosomal events~     implicated in bladder cancer.~   "
205495|NCT00871741|"~     This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A~     vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.~   "
205496|NCT00871728|"~     The purpose of this study is to evaluate the participants with toenail onychomycosis (fungal~     infection of the nail) confirmed positive by potassium hydroxide (KOH) and bacterial~     identification test after administration of itraconazole (ICZ) capsule, to identify the~     change in Scoring Clinical Index for Onychomycosis (SCIO) score and to determine the~     relationship between the change of SCIO score and mycological cure rate and clinical~     improvement.~   "
205497|NCT00871715|"~     This study is about arm and hand recovery after a stroke. The investigators are testing an~     experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines~     challenging, intensive and meaningful practice of tasks of the participant's choice compared~     to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual~     and customary arm therapy for a duration indicated on the therapy prescription). A second~     objective is to characterize current outpatient arm therapy (dosage & content) following~     stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke~     affecting an arm within the last 106 days.~   "
205498|NCT00871702|"~     Primary Objective:~        -  To determine if there is significant toxicity associated with the administration of~          CD34-TK75 transduced donor lymphocytes after allogeneic BMT for relapsed hematologic~          malignancies~      Secondary Objectives:~        -  To determine if the patient develops any evidence of anti-leukemic effect from the~          administration of CD34-TK75 transduced donor lymphocytes~        -  To determine if ganciclovir administration to patients who develop Graft versus Host~          Disease (GVHD)results in clinical improvement after infusions of CD34-TK75 transduced~          lymphocytes.~      Sub-Study Objective~      The primary purpose is to perform PET imaging of CD34-TK transduced allogeneic donor T cells~     in patients who have relapsed hematologic malignancies after allogeneic hematopoietic stem~     cell transplantation (SCT). At this time the limited amount of cGMP quality virus produced by~     the NGVL will likely permit the imaging of only 3 patients. Consequently our current~     objective will be to establish that the TK-expressing cells can be detected by 18FHBG-PET in~     patient organs relevant for performing additional studies that are currently in the planning~     stages and for which we are working to produce additional virus.~      The ultimate objective will be to use the TK substrate 18FHBG to locate the donor T cells~     within the recipient as they exert anti-leukemic effects, and the T cells can then be~     eliminated in response to in vivo administration of ganciclovir, before morbidity and~     mortality from GvHD occurs. We will use the imaging strategy to define patterns of T cell~     trafficking in humans pre and post-DLI infusion, and to determine where the cells reside~     while they mediate GVL in contrast to GvHD. We expect to obtain in vivo PET imaging markers~     predictive of GvHD before clinical symptoms occur.~   "
205499|NCT00871689|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood~     stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells and natural~     killer cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Giving~     interleukin-2 (IL-2, aldesleukin) after transplant may stimulate the natural killer cells to~     kill any remaining cancer cells.~      PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy~     together with total-body irradiation followed by interleukin-2 (IL-2, aldesleukin), and~     umbilical cord blood transplant and to see how well it works in treating patients with~     relapsed or refractory acute myeloid leukemia.~   "
205500|NCT00871676|"~     This purpose of this study was to test the use of chewing gum as an adjunct to lifestyle~     modification to facilitate appetite control and weight loss in overweight and obese~     individuals.~   "
205501|NCT00871663|"~     The study will evaluate the safety, tolerability, maximum administered dose, and dose~     limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15~     of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple~     myeloma or chronic lymphocytic leukemia.~   "
205502|NCT00871650|"~     The overarching aim of this Exploratory/Developmental Research Grant Award (R21) is to~     explore the neurobiological correlates of PTSD during REM sleep by using state-of-the science~     positron emission tomography (PET) sleep imaging. This study will allow us to gain insight~     into the differences in sleep and waking brain mechanisms between veterans with PTSD and~     those without PTSD.~   "
205503|NCT00871637|"~     Airway macrophage impairment is a central feature in the immunopathogenesis of chronic~     obstructive pulmonary disease, regardless of smoking status.~   "
205504|NCT00871624|"~     The purpose of the study is to determine the efficacy and safety of dexmedetomidine during~     Non-invasive positive pressure ventilation (NPPV) for patients with acute respiratory failure~     compared to standard analgesic/sedation practices~   "
205505|NCT00871611|"~     The prevalence of Anderson - Fabry disease in patients with left ventricular hypertrophy is~     unclear. The investigators will examine urine - α - Galactosidase activity and~     globotriaosylceramide isoforms in these patients.~   "
205548|NCT00871039|"~     The aim of this study is to evaluate the effects of the sedatives propofol and midazolam on~     stress response and immune function in critically ill patients with alcohol use disorders who~     are undergoing mechanical ventilation.~   "
205506|NCT00871598|"~     Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous~     doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the~     pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups~     will occur at random, and the actual treatment will not be revealed to the investigator or to~     the patient during the trial.~   "
205507|NCT00871585|"~     Prospective, non-comparative, non-interventional, observational study to collect and analyse~     real life environment data on advanced prostate cancer patients receiving combination~     treatment of medical or surgical castration and bicalutamide according to routine medical~     practice in Croatia. The main aim is to evaluate change of PSA level and prescribing~     practices based on prostate cancer stage.~   "
205508|NCT00871572|"~     This drug is being evaluated for possible treatment of type 2 diabetes mellitus.~     Participation in this study is expected to last up to 18 weeks. A goal of this study is to~     determine the safety and effectiveness of LY2409021.~   "
205509|NCT00871559|"~     The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in~     patients with advanced solid malignancies.~   "
205510|NCT00871546|"~     Participants will be randomized to SCH 727965 or a comparator drug (bortezomib for mantle~     cell lymphoma [MCL] or alemtuzumab for B cell chronic lymphocytic leukemia [B CLL]). Part 1~     of the study will determine the activity of SCH 727965 treatment in participants with MCL and~     participants with B-CLL. Part 2 of the study will determine the activity of SCH 727965~     treatment in participants who experienced disease progression after standard treatment with~     the comparator drug during Part 1.~   "
205511|NCT00871533|"~     The presence of malignant cells in lymph nodes is a critical parameter in the staging of~     melanoma cancer patients. Assessment of lymph nodes is currently done by histopathology~     alone. The long-term survival of melanoma cancer patients who have Stage IB disease (no known~     lymph node involvement with a tumor greater than 2 cm) is lower than patients who are Stage~     IA (no known lymph node involvement with a tumor less than 2 cm). Likewise, the survival~     rates of patients who are judged to be Stage II based on histologically positive level-one~     lymph nodes is often no better than that of higher stage patients who have level-two lymph~     node involvement. These observations suggest that micrometastases are often present in lymph~     nodes that are not detectable by histological assessment.~      The collection of Sentinel Lymph Nodes (SLN) and non SLN material outlined in this proposal~     will permit both targeted and exploratory studies, without compromising the patient's~     diagnosis, on specimens that represent central engines of the immune response and whose~     function in the context of tumor progression is largely unknown.~      With the advent of an array of new methodologies that utilize minimum material for both~     molecular and cellular assessments, acquiring up to 20% and in general the investigators~     anticipate the use of 5% on average of SLN and/or non SLN tissue for research purposes, may~     prove to be critical to understanding the impact of nodal tumor involvement on patient~     outcome and survival.~   "
205512|NCT00871520|"~     The accuracy of clinical survival estimates is tested in comparison to objective prognostic~     scores.~   "
205513|NCT00871507|"~     This study will assess the safety, tolerability, pharmacokinetics (explores what the body~     does to the drug), and pharmacodynamics (explores what a drug does to the body) of~     JNJ-38431055 in volunteers with type 2 diabetes mellitus.~   "
205514|NCT00871494|"~     Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical~     bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and~     eradication rate in the western clinical trials. Development of azithromycin intravenous~     formulation would bring the clinical benefit to patients with pelvic inflammatory disease~     (PID) in Japan.~   "
205515|NCT00871481|"~     This phase I/II trial is studying the side effects of giving laboratory-treated T cells and~     ipilimumab together to see how well they work in treating patients with metastatic melanoma.~     Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells~     when they are put back in the body. Monoclonal antibodies, such as ipilimumab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     laboratory-treated T cells together with ipilimumab may kill more tumor cells~   "
205516|NCT00871468|"~     The anterior-inferior clavicle plate position will have a lower rate of soft tissue~     irritation that limits activity and/or requires hardware removal compared to superior plate~     position.~   "
205517|NCT00871455|"~     Insulin-like growth factor I (IGF-I) is used as a measure of the body's ability to produce~     growth hormone. Growth hormone is important for muscle tissue as well as many other tissues~     in the body. Growth hormone (GH) and IGF-I have been shown to be reduced in many persons with~     SCI. Baclofen is a FDA approved drug that is used to treat spasticity. Persons receiving~     long-term baclofen therapy have been demonstrated to have increased growth hormone and IGF-I~     levels. IGF-I levels will be determined before and after treatment with baclofen. In this~     study, the investigators will determine the minimum dose of baclofen at which improvements in~     GH and IGF-1 levels occur.~   "
205518|NCT00871442|"~     Patient Controlled Epidural Analgesia is a widely used and effective means of adult pain~     management. However, Parturient Controlled Epidural Analgesia (PCEA) is a relatively new~     approach to pain control for the women in labor. With the recent acquisition of new PCEA~     technology at Baystate Medical Center it is now possible to make this patient controlled~     technology available on the Labor and Delivery unit. This study is designed to determine~     whether there is a difference in analgesia, side effects, or analgesic duration in patients~     who receive a bupivacaine and fentanyl PCEA for management of labor pain. The present study~     hypothesizes that an analgesic protocol that includes a basal infusion rate in addition to a~     bolus dose controlled by the patient will have a longer analgesic duration than a pump~     protocol that does not have a basal infusion added to a bolus dose controlled by the patient.~      Methods:The study population will consist of 100 adult obstetrical patients greater than 36~     weeks gestation who request labor analgesia. Patients greater than 5 cm cervical dilation,~     patients who have received intravenous opioid agonists, or patients with a contraindication~     to fentanyl will be excluded. Patients with pre-eclampsia are also excluded.~      One of the following PCEA treatment protocols will be started in a randomized, double blind~     fashion.PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 1: Basal Infusion: 0~     ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout) Group 2: Basal Infusion:~     10 ml/h; Bolus 5 ml q 30min prn (5ml demand dose with 30min lockout) If the patient does not~     obtain relief within 30 minutes, the epidural catheter will be dosed with a local anesthetic~     and the study will be concluded. The patients without pain relief within 30 minutes are~     considered to have failed epidurals and are dropped from the study and the analysis.~     Following achievement of satisfactory analgesia, the patient will be evaluated every 30~     minutes until they request additional analgesics. The study will end at this point, and the~     patient will be treated at the discretion of the anesthesiologist.~   "
205563|NCT00870844|"~     The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO)~     dosed once daily for 5 days is a safe treatment for patients who have suffered an acute~     ischemic stroke.~   "
205519|NCT00871429|"~     This study is being done because the investigators would like to evaluate product~     satisfaction of three test products (product A, product B, product C) that are available at~     any drug store. This will be done by measuring any changes in the subjects' answers to the~     Skindex-16 questionnaire at two time points (at screening and baseline visit and at follow-up~     visit) and by evaluating their responses to the product satisfaction survey that will be~     given to them by a study coordinator.~   "
205520|NCT00871416|"~     This trial is conducted in Europe. The primary aim of this clinical trial is to locate and~     compare simulated insulin injections (injections of sterile atmospheric air) in normal weight~     and obese patients with diabetes mellitus. Injections are done with 6 mm and 12 mm needles~     with and without lifting of skin fold at different injection sites.~   "
205521|NCT00871403|"~     The main purpose of this study is to determine whether the combination of pazopanib and~     pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer~     (NSCLC).~   "
205522|NCT00871390|"~     Atrial fibrillation (AF) is a condition in which the upper chambers of the heart, the atria,~     undergo an irregular beating rhythm. Despite the fact that AF is the most common type of~     sustained cardiac rhythm disturbance the investigators still do not understand it entirely~     and its current therapies are only marginally effective. The overall goal of our project is~     to determine the organization and mechanisms of electrical activation patterns during AF in~     humans.~   "
205523|NCT00871377|"~     The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify~     cardiac risk factors in people with epilepsy.~   "
205524|NCT00871364|"~     The purpose of this study to assess the single-dose relative bioavailability of Actavis Group~     hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg~     venlafaxine (as venlafaxine hydrochloride) tablets under fed conditions.~   "
205525|NCT00871351|"~     The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and~     ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose~     low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target~     value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or~     changing to rosuvastatin 2.5 mg.~   "
205526|NCT00871338|"~     The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals'~     GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy~     infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a~     booster dose of GSK Biologicals' Menitorix™ at 12 months of age.~   "
205527|NCT00871325|"~     The purpose of this study is to compare the dose related effects of orally administered~     TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal~     motility and colonic transit of solids.~   "
205528|NCT00871312|"~     The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2)~     therapy system on the healing of diabetic lower extremity ulcers.~   "
205529|NCT00871299|"~     This study is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT)~     versus Health-Enhancement Program (HEP) for patients with treatment-resistant major~     depressive disorder (MDD). Both arms of the study will continue to receive the standard~     medication management treatment as usual (TAU) throughout the study. MBCT is a new technique~     that has been found to be effective for prevention of relapse in individuals in complete~     recovery from depression. MBCT is a group-based, 8-week intervention that uses mindfulness~     meditation as its core therapeutic ingredient. It teaches people to have a different~     relationship to depressive thoughts and feelings. This study will use an active condition~     called the Health Enhancement Program (HEP) which was specifically developed to serve as a~     comparison condition for mindfulness interventions. HEP has been shown to decrease global~     stress levels and to increase perceived health. Stress has been considered a contributor to~     depression. One hundred and seventy four patients with MDD who have failed two or more~     adequate antidepressant trials will be identified and randomly assigned to one of two groups:~     MBCT+TAU or HEP+TAU. All patients who enroll in the study will undergo follow-up assessments~     at 3, 6, 9 and 12 months following the intervention. A supplemental portion of the study will~     enroll 88 patients to undergo functional magnetic resonance imagining (fMRI) scans~     immediately before and after treatment to better understand the neural pathways implicated in~     depression and those that may be affected through treatment.~   "
205530|NCT00871286|"~     The purpose of this research study is to determine whether or not computed tomography (CT)~     scans performed on patients with symptoms of chronic rhinosinusitis (CRS) but without any~     physical signs of the disease will (1) prove to be less expensive in the treatment and~     evaluation as compared to current practices, (2) avoid the use of unnecessary antibiotic~     prescriptions, and (3) provide a more efficient way to diagnose conditions in patients who~     have had CRS ruled out as a cause.~      The investigators hypothesize that current guidelines, when applied to subjects with symptoms~     of CRS in the absence of physical signs may be associated with (1) increased unnecessary~     prescription of antibiotics, (2) delay in further essential workup, and (3) increased overall~     health care costs.~   "
205531|NCT00871273|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of capecitabine in~     patients who have undergone a total gastrectomy.~   "
205532|NCT00871260|"~     The purpose of this study is to better define the role of a comprehensive stress MRI (which~     includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar~     imaging) in medical practice and in patient health management. Information gathered from the~     healthy volunteers that participate in this study will be compared to information from the~     coronary artery disease patients in this study in order to help further our understanding.~   "
205533|NCT00871247|"~     The purpose of this study is to compare the rate and extent of absorption of Actavis Group~     hf, Iceland, finasteride and Merck & Co. Inc., U.S.A. (Proscar), finasteride, administered as~     a 1 x 5 mg tablet, under fed conditions.~   "
205534|NCT00871234|"~     The purpose of this study is to determine the safety and effects of etravirine, an HIV~     antiretroviral medication, on vascular function.~   "
205535|NCT00871208|"~     This study is designed to determine whether the addition of topical Altabax (R) to a~     treatment regimen of topical corticosteroid therapy speeds clearance of atopic dermatitis and~     improves quality of life.~   "
218617|NCT00697515|"~     To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult~     workplace environment (AWE) setting~   "
205536|NCT00871195|"~     The objective of this study is to evaluate the performance of Sequenom's noninvasive test for~     fetal RHD genotype. The test uses MALDI-TOF mass spectrometry to detect DNA. The study is~     specifically designed to determine whether RHD typing using free fetal DNA in maternal~     circulation can accurately predict the neonatal RhD phenotype at birth.~   "
205537|NCT00871182|"~     The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to~     placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary~     disease (COPD).~   "
205538|NCT00871169|"~     This phase II trial studies the side effects and how well irinotecan hydrochloride,~     oxaliplatin and cetuximab work in treating patients with unresectable or metastatic~     pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth~     in different ways. Some block the ability of tumor to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Giving irinotecan~     hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.~   "
205539|NCT00871156|"~     DDI study of Tafenoquine and Chloroquine~   "
205540|NCT00871143|"~     The aim of the research is to determine if Cognitive Behaviour Therapy (CBT) specific for BDD~     is more effective than a credible non-specific form of CBT for treating BDD and its~     delusional variant in adults aged 17 or over. This will be done in a single centre randomised~     controlled trial that compares specific CBT for BDD versus non-specific CBT over 12 weeks.~     The hypotheses to be tested are that: (1) specific CBT for BDD will be more effective than~     non-specific CBT at 12 weeks (2) Treatment effects from Specific CBT will be maintained at 1~     month follow up. The main study end-point is at 12 weeks and the secondary end-point is at 1~     month follow up. A secondary aim is to explore whether delusionality (insight) as measured by~     the Brown Assessment of Beliefs and co-morbid depressed mood predicts response to treatment.~   "
205541|NCT00871130|"~     The aim is to evaluate the effect of dramatic weight loss after bariatric surgery on thyroid~     function (thyroid hormone levels and particulary morphological changes) in the short and~     long-term setting of a cross-sectional study. A particular focus will be made with regard to~     putting into correlation preoperative thyroid function abnormalities and postoperative~     changes over time with respect to the type of bariatric intervention carried out.~   "
205542|NCT00871117|"~     The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when~     co-administered with varicella (Varivax® [varicella virus vaccine live], Merck and Company)~     and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine~     alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age,~     and there is great potential for the vaccines to be given concurrently. The aim of this trial~     is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity~     or reactogenicity of Kinrix.~   "
205543|NCT00871104|"~     The study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of~     methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to~     vancomycin, the standard therapy.~   "
205544|NCT00871091|"~     In orthodontics, conventional fixed appliances, usually consisting of prefabricated~     components, require step-by-step adjustment in order to move teeth in the planned direction.~      May treatment be improved with customized archwires?~      Study hypotheses:~        -  By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth~          movements can be avoided and teeth can be moved on their direct path to the intended~          position.~        -  The application of CAD/CAM improves reproducibility, efficiency, and quality of~          orthodontic treatment.~   "
205545|NCT00871078|"~     The purpose of this study is to assess retinal nerve fiber layer thickness and macular~     thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus~     without ocular manifestations and to correlate these results with perimetric findings~     assessed by frequency doubling technology perimetry (FDT).~   "
205546|NCT00871065|"~     Rupture of a cerebral aneurysm is a serious medical condition that may result in permanent~     disability or even death just related to the aneurysm rupture itself. Patients who undergo~     successful surgical treatment of their aneurysm will rarely experience problems related to~     that specific aneurysm in the future. However, blood that is on the surface of the brain from~     the initial aneurysm rupture is very irritating to other blood vessels that it comes in~     contact with. When these blood vessels become irritated, they spasm and become narrower. This~     narrowing restricts blood flow through the vessel, and if severe can result in a stroke that~     is caused by inadequate blood flow through the vessel. Depending on location and severity,~     this condition of vessel spasm (cerebral vasospasm) may result in permanent disability or~     death. Treatment to prevent cerebral vasospasm decreases the risk of stroke. This research is~     trying to see if a medication that is FDA approved for the treatment of lung disease and~     sexual dysfunction can be used to prevent and/or treat cerebral vasospasm.~   "
205547|NCT00871052|"~     Polymorphic light eruption (PLE) is a photodermatosis with an extremely high prevalence,~     particularly among young women (up to 20%). The disease is characterized through itchy skin~     lesions on sun-exposed body sites occurring after sun exposure mostly in spring and early~     summer. Its etiopathogenesis is unknown but resistance to ultraviolet radiation (UVR)-induced~     immunosuppression with subsequent immune reactions against skin photoneoantigens has been~     suggested.~      The phenomenon of UVR-induced immunosuppression (suppression of CHS) has been well known for~     many years. Recent findings showed that regulatory T cells (CD4+CD25+FoxP3+) (Tregs), a~     subset of T helper cells, are crucial in UVR-induced immunosuppression. However, the~     requirements for the maintenance of peripheral CD4+CD25+ T cells, important in suppression of~     immune responses, are still incompletely understood. Recent work suggests that cutaneous~     RANKL might be the physiologic missing link that couples UVR to immunosuppression. Epidermal~     RANKL, expressed in keratinocytes of inflamed skin due to e.g. UVR exposure was shown to~     control the number of Tregs via activation of dendritic cells, hereby mediating UVR-induced~     immunosuppression (e.g. suppression of allergic contact hypersensitivity responses). In~     addition to the suppression of local cutaneous hyperallergic responses, the development of~     systemic autoimmunity is suppressed. A strong inducer of RANKL expression and of Tregs is~     vitamin D3 that has been reported to have immunosuppressive effects. Interestingly, patients~     with autoimmune disorders (e.g. lupus erythematosus) may exhibit reduced vitamin D3 blood~     levels.~      This randomized, double blinded left-right body side experimental comparison study was~     designed to assess the preventive effect of the vitamin D3 analogue calcipotriol in patients~     with PLE. The hypothesis is tested that treatment with a calcipotriol-containing cream can~     prevent the UVR-induced development of PLE skin lesions. Better insight into the pathogenesis~     of PLE may give clues to develop new therapeutic strategies.~   "
205549|NCT00871026|"~     In orthodontics, conventional fixed appliances, usually consisting of prefabricated~     components, require step-by-step adjustment in order to move teeth in the planned direction.~      May treatment be improved with customized archwires?~      Study hypotheses:~        -  By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth~          movements can be avoided and teeth can be moved on their direct path to the intended~          position.~        -  The application of CAD/CAM improves reproducibility, efficiency, and quality of~          orthodontic treatment.~   "
205550|NCT00871013|"~     There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma~     at the MIRT from 1989 to present. Results have shown that participants treated on these~     studies had better outcomes (meaning they have lived longer and had better responses to~     treatment) when compared to individuals treated with standard chemotherapy.~      Past studies conducted at the MIRT have shown that participants presenting to MIRT who have~     already received treatment for myeloma tend to have shorter remissions (disappearance of~     signs and symptoms of myeloma) and do not survive as long as participants who come to MIRT~     with untreated myeloma. Researchers at MIRT think that one reason for this is may be that the~     myeloma cells re-grow in the time when participants are not receiving treatment because they~     are recovering from high-dose chemotherapy. In this study, participants will receive several~     chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in~     shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have~     time to re-grow between cycles, therefore resulting in longer remissions. This study is being~     done in an attempt to improve the remission rate and the survival time for participants with~     high-risk myeloma.~   "
205551|NCT00871000|"~     This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV~     vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children~     5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine~     according to the 3-5-11 month schedule recommended in Italy.~      In this study, MMRV vaccine will also be co-administered to all children.~   "
205552|NCT00870987|"~     The purpose of this study is to test the safety and effectiveness of a new malaria vaccine,~     the DNA-Ad vaccine. The study is specifically looking at a vaccine regimen against Plasmodium~     falciparum, the most deadly form of malaria.~   "
205553|NCT00870974|"~     Measurement of metabotropic glutamate receptor type 5 (mGluR5) binding capacity in the brain,~     may be a valuable tool in the early detection, understanding, or evaluation of Parkinson~     disease (PD), Huntington disease (HD), Fragile X syndrome (FXS), Autism Spectrum~     Disorder(ASD), Alzheimer's Disease(AD), and subjects with mild cognitive impairment (MCI).~      The goal of this study is to assess [18F]F-PEB positron emission tomography (PET) imaging as~     a tool to detect mGluR5 density in the brain of PD, HD, FXS ASD, AD, and MCI research~     participants and similarly aged healthy subjects.~   "
205554|NCT00870961|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of vitamin D may keep colorectal cancer from forming in patients with colon polyps.~      PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it~     works compared with a placebo in preventing colorectal cancer in African Americans with colon~     polyps.~   "
205555|NCT00870948|"~     Single dose in healthy volunteers to assess bioavailability (amount of study drug in the~     system) between different formulations of ABT-874.~   "
205556|NCT00870935|"~     The purpose of this study is:~        -  to determine whether the choice of the device for performing hysterosalpingography on~          the basis of the cervix characteristics can reduce the procedure failure rate;~        -  to determine whether patient medical history is correlated with the degree of pain~          experienced during the HSG procedure.~   "
205557|NCT00870922|"~     Muscles and myofascial dysfunction are more often the mechanism and source of pain in oral~     fascial disorders (OFD) than the TMJ. Masticatory muscles in patients with TMJ alterations~     are more hypertonic, less efficient and more prone to fatigue compared to age and sex matched~     controls. It is our opinion that Active Release Technique can be a reliable assessment and~     treatment tool in the resolution in cervical-cranio mandibular disorders. Our goal is to~     improve masticatory function through treatment of trigger points in the masseter.~   "
205558|NCT00870909|"~     The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is~     effective in the treatment of auditory hallucinations in schizophrenia.~   "
205559|NCT00870896|"~     Does tiotropium effect the cough reflex in patients with COPD and chronic bronchitis.~   "
205560|NCT00870883|"~     Oxidative stress is associated with kidney damage in several different situations, including~     hypotension. In animal models it has been shown that the combination of n-acetylcysteine plus~     deferoxamine is superior to its isolate use in the treatment of several diseases. Thus the~     investigators aimed to determine if the administration of n-acetylcysteine plus deferoxamine~     could prevent renal failure in critical ill patients who develops hypotension.~   "
205561|NCT00870870|"~     The purpose of this study is to determine the number of participants whose cancer shrinks or~     disappears after treatment on the study.~   "
205562|NCT00870857|"~     Despite the availability of highly active antiretroviral therapy (HAART), lung diseases~     remain a leading cause of morbidity and mortality in those with HIV infection. There have~     been no large-scale studies detailing pulmonary complications in the HAART era. Substantial~     gaps exist in our knowledge of the spectrum and pathogenesis of pulmonary disorders in this~     population, particularly in women and minorities whose numbers with HIV or AIDS have~     increased. The Multicenter AIDS Cohort Study (MACS) and the Women's Interagency Health Study~     (WIHS) are prospective, multi-center cohorts that follow approximately 5000 HIV+ subjects and~     HIV- controls. Although pulmonary disease has not been an area of focus, these established~     cohorts provide a unique opportunity to systematically study pulmonary complications of HIV~     infection.~      Emphysema is of particular interest in the current HIV era because it is likely to increase~     as this population lives longer with chronic HIV. HIV-infected persons have an increased~     incidence of emphysema compared to those without HIV infection, and it has been hypothesized~     that this accelerated disease progression is the result of one or more latent infectious~     agents that amplify the pulmonary inflammation. Accelerated emphysema was described in HIV~     infection in a predominantly male population before HAART. The current prevalence and~     characteristics of HIV-associated emphysema, and the potential impact of gender, have not~     been rigorously defined.~   "
205566|NCT00870805|"~     Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is~     one of the safest and most effective treatments available for depression. Despite modern~     advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive~     treatment with ECT. Its use, however, is limited by concerns over associated cognitive side~     effects.~      Recent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce~     cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results~     were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to~     be adjusted to preserve efficacy while reducing side effects. This study will examine the~     relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with~     a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI~     scan before and after ECT.~   "
205567|NCT00870792|"~     We hypothesized that providing physicians treating with HIV disease, at the time of a routine~     outpatient visit, with a detailed report describing patients' adherence with HIV~     antiretroviral medications, would improve the quality of the physician-patient interaction,~     and also patients' subsequent adherence.~   "
205568|NCT00870779|"~     Removing a tumor from your brain is hard to do because, very often, brain tumors do not have~     boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell~     exactly where the tumor begins or ends. The surgeon usually can remove most of your tumor by~     looking at the MRI images that were taken of your brain before surgery. However, the surgeon~     does not have any good way to tell if the entire tumor has been removed or not. Removing the~     entire tumor is very important because leaving tumor behind may allow it to grow back which~     could decrease your chances of survival.~      It is possible to detect tumor cells by making them glow with a specific color of light (a~     process called fluorescence). This can be done by having you take the drug, ALA, before your~     surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it~     is in your body, it gets converted into another molecule named PpIX. If blue light is shined~     on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be~     detected with a special camera. In this study, we want to determine how the fluorescence (red~     light) is related to the tumor which appears in the images that are normally taken of your~     brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that~     will be removed during your surgery. Removing the entire tumor is very important because~     leaving tumor behind may allow it to grow back which could decrease your chances of survival.~   "
205569|NCT00870766|"~     The purpose of this study is to determine the impact of routinely performed early CT scanning~     in terms of diagnostic accuracy, patient management and cost-effectiveness compared to~     current imaging practice in patients suffering from acute abdomen.~   "
205570|NCT00870753|"~     Purpose: to examine effects of hatha yoga in treatment of eating disorders.~      Methods:~      Participants: patients with DSM-IV Anorexia Nervosa, Bulimia Nervosa or Eating Disorders Not~     Otherwise Specified will be invited to participate in this study. Exclusion criteria will be~     age under 18, serious medical complications, psychosis or increased risk of suicide.~      Design: randomized controlled single-blinded trial. Intervention: 2 x 90 min weekly group~     sessions for 12 weeks with hatha yoga. Main outcome measure: reduction in Eating Disorders~     Examination score. Secondary outcome measures: reduction in body dissatisfaction, depression~     and anxiety~   "
205571|NCT00870740|"~     The primary objective of the study was to assess the safety and immunogenicity of extended~     treatment with DAC HYP. This evaluation included the following major components:~        -  An assessment of safety and immunogenicity of extended treatment with DAC HYP when~          administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in~          Study 201.~        -  An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.~        -  An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP~          after a 6-month washout period.~        -  An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects~          who previously received placebo during Study 201.~      The secondary objective is to assess the durability of the effect of DAC HYP on multiple~     sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans~     and clinical MS relapses.~   "
205572|NCT00870727|"~     The purpose of this study is to develop a better tolerated and more effective pharmacologic~     treatment with individuals with Pervasive Developmental Disorder. This is a double-blind,~     placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of~     Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be~     more effective than placebo for reducing aggression,tantrum and self-injurious behavior in~     children with Pervasive Developmental Disorder.~   "
205573|NCT00870714|"~     Eligible patients with high-risk prostate cancer who are scheduled to undergo radical~     prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to~     surgery resection. A cycle of therapy is defined as 21 days (three weeks). Pharmacokinetic~     analysis will be performed with the first and second cycle of therapy. All patients will be~     evaluated for toxicity, tumor response, and recurrence.~   "
205574|NCT00870701|"~     Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas~     members represent 60% of them.~      These rare tumors involve complex multidisciplinary care better in centers having expertise.~      Loco-regional therapy strategies have evaluated over time for tumors of members leading to~     propose more often the combination of a large conservative tumor excision with radiotherapy.~     Results have been demonstrated equivalent to those of an amputation in terms of local control~     and survival.~      The local recurrence rate for sarcomas of the members of any kind after surgery with or~     without radiotherapy in the literature varies from 10 to 30%.~      The main objective is to achieve a low recurrence rate while maintaining the function. The~     question remains the possibility of an absence of irradiation in selected cases in a~     de-escalation therapy order.~   "
205575|NCT00870688|"~     Valproate is the first line therapy in primary generalized seizures. The applied drug~     contains sodium valproate in sustained release minitablets. As a multiple unit dosage form~     these can be easily swallowed and taken independent from meals.~      A simple dosage scheme like valproate sustained release minitablets once daily in the evening~     should improve the compliance and likely the seizure situation of the patients. The data of~     this non interventional trial were directly extracted from the physician's electronic patient~     database. The observational period was 7 weeks compared to a retrospective period 7 weeks~     before start of the study.~   "
205576|NCT00870675|"~     This study compares the accuracy of fast magnetic resonance imaging (MRI) using the half~     Fourier single shot rapid acceleration with relaxation enhancement technique to ultrasound in~     the diagnosis of fetal abnormalities. The investigators' specific aim is to perform MRI~     examinations with ultrafast MRI on fetuses with sonographic morphologic abnormalities. The~     investigators' hypotheses are that 1) MRI will demonstrate fetal morphologic abnormalities;~     and 2) MRI will add additional information to the sonographic diagnosis which may directly~     affect maternal and/or neonatal care.~   "
205577|NCT00870662|"~     The purpose of this study is to determine whether the Automatic Fluid Shunt (AFS) can reduce~     the number of paracentesis procedures in patients with refractory ascites.~   "
205578|NCT00870649|"~     Objectives:To reduce the risk of S. haematobium pathology recurrences during the three years~     following vaccine administration and to control the safety of this therapeutic strategy in~     children exposed to urinary schistosomiasis.~      Methodology : Phase III trial, self-contained, randomized, double blind, in two parallel~     groups receiving 3 injections at D0, W4, W8 and a boost at W52, one group receiving~     Bilhvax, the other one placebo, in S. haematobium infected children pretreated by two doses~     of PZQ (at W9 and W8) Patient included : Infected school children, 6 to 9 years of age.~      Primary objective : To demonstrate a significant delay of recurrence of the schistosomiasis~     pathology in vaccine group compared to control group in the 3 years period following the~     first administration (between D0 and W152).~      Secondary objective : safety~      Duration : February 2009 to March 2012~   "
205579|NCT00870636|"~     The purpose of this study is to provide access to intravitreal injection of Avastin in~     high-risk infants who do not otherwise qualify for study NCT00702819, an investigational~     multi-site study examining Avastin use for retinopathy of prematurity.~   "
205580|NCT00870623|"~     Bloodstream infections (BSI) are a major cause of morbidity and mortality. Community-onset~     BSI have an overall attributable mortality of 10-13% while nosocomial BSI mortality ranges~     are quite variable from 12-80%. Bloodstream infections are also costly and result in~     prolonged hospital stays. Nosocomial BSIs have been shown to increase length of stay by 5-25~     days and increase costs $23,000 - 40,000 above matched controls. The duration of therapy~     necessary to clear blood stream infections is unknown and no study has systematically~     addressed this issue. The use of antimicrobials is also not without consequence. These~     include financial cost, side-effects, promotion of superinfection (especially Clostridium~     difficile-associated diarrhea), and the promotion of microbial resistance. We hypothesize~     that a procalcitonin (host biomarker) and endotoxin (microorganism biomarker)-guided~     treatment plan could significantly decrease unnecessary exposure to antibiotics in patients~     with bloodstream infections.~   "
205581|NCT00870610|"~     The purpose of this study is to understand what happens to cerebral metabolism during~     therapeutic hypothermia for hypoxic brain injury following cardiac arrest.~   "
205582|NCT00870597|"~     The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless~     vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal~     intraocular lens (IOL) implantation.~   "
205583|NCT00870584|"~     This study will evaluate the effect of omalizumab on markers of impairment in patients with~     inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in~     the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines~   "
205584|NCT00870571|"~     The purpose of this study to assess the single-dose relative bioavailability of Actavis Group~     hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fed conditions.~   "
205585|NCT00870558|"~     RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It~     is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled~     ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for~     liver cancer.~      PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how~     well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in~     patients who have undergone treatment for liver cancer.~   "
205586|NCT00870545|"~     This study will expand the Department of Defense (DoD) one time, face-to-face post deployment~     BATTLEMIND training for spouses of Operation Enduring Freedom/Operation Iraqi Freedom~     (OEF/OIF) Guard/Reserve service members into year-long, telephone groups focusing on~     education, skills building and support. The goal is to build spouses' resilience to cope with~     reintegration, help them serve as a support system for returning service members, and ease~     the transition for families post-deployment.~   "
205587|NCT00870532|"~     Targeting the blood supply of cancer, called anti-angiogenesis is a new but proven treatment~     strategy. There are two ways of achieving this effect. The first way to specifically target~     the molecular pathways that promote new blood vessel formation in cancer. An example of such~     an agent is sorafenib, which is an oral agent and which is already in use worldwide for the~     treatment of kidney and liver cancers. The second way is to target the cells lining the blood~     vessels by using low dose of chemotherapy agents administered at frequent intervals. This~     strategy is called metronomic chemotherapy. It is possible that combining agents like~     sorafenib and metronomic chemotherapy may further enhance anti-cancer effects. This study~     aims to determine the optimal way of combining oral vinorelbine in metronomic doses and~     sorafenib. Oral vinorelbine is a chemotherapy agent that is already approved for use in~     cancer treatment such as lung cancer. By combining both oral anti-cancer agents to optimize~     their anti-angiogenic effects in this study, the potential benefit to the patients can be~     tremendous and far-reaching. Special radiologic imagings and blood tests will be incorporated~     into this study to help further the understanding of the anti-angiogenic processes of both~     agents.~   "
205588|NCT00870519|"~     The underlying goal of this study is to assess 123-I MNI-168 SPECT imaging as a tool to~     detect ß-amyloid deposition in the brain of Alzheimer's Disease (AD) research participants~     and similarly aged and gender matched healthy subjects.~   "
205589|NCT00870506|"~     The purpose of this study is to determine the effect of a 5-minute video intervention~     regarding organ donation and transplantation on increasing the number of organ donor cards~     signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to~     donate organs while living. The investigators hypothesize that persons in the intervention~     group will sign more donor cards and be more willing to donate organs while living than~     persons in the control group.~   "
205590|NCT00870493|"~     Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in~     the world. Current treatment with angiotensin converting enzyme (ACE) inhibitor and~     angiotensin receptor blocker (ARB) is not entirely effective. Aliskiren, a direct renin~     inhibitor, acts on the rate limiting step of the renin-angiotensin axis. In addition to~     lowering the blood pressure, recent study in diabetic nephropathy suggests an independent~     anti-proteinuric effect. The investigators plan to conduct a randomized placebo-control~     cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of IgA~     nephropathy. The investigators plan to recruit 57 patients with biopsy-proven IgA nephropathy~     and persistent proteinuria despite conventional therapy. They will be randomized to aliskiren~     for 16 weeks or no treatment, followed by cross over to the other arm after a washout period.~     Proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. This~     study will explore the potential anti-proteinuric effect of aliskiren in the treatment of IgA~     nephropathy, which has no specific treatment at present.~   "
205591|NCT00870480|"~     The purpose of this study to compare the rate and extent of absorption of Actavis Group hf,~     Iceland, finasteride and Merck & Co. Inc., U.S.A. (Proscar), finasteride, administered as a 1~     x 5 mg tablet, under fasting conditions.~   "
205592|NCT00870467|"~     To evaluate the potential of adalimumab to inhibit radiographic progression in joint~     destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid~     arthritis.~   "
205593|NCT00870454|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     carisbamate (800 and 1200 mg/day) in patients with diabetic neuropathic pain.~   "
205594|NCT00870441|"~     The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in~     healthy male and female adult volunteers.~   "
205595|NCT00870428|"~     The investigators intend to perform a large prospective study looking at the predictability~     of the random urine protein-to-creatinine ratio compared to the gold standard 24-hour urine~     protein collection. Furthermore, the investigators plan to investigate whether analysis of~     proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-hour collection~     period is predictive of the 24-hour sample. Lastly, the investigators plan to determine~     whether a combination of the random test with a shorter collection interval is comparable to~     the 24-hour collection.~   "
205596|NCT00870415|"~     RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and~     may have fewer side effects and improve recovery.~      PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in~     treating women with breast cancer.~   "
205597|NCT00870402|"~     The purpose of this study is to determine whether spironolactone are effective in the~     reduction of albuminuria and diastolic disfunction of subjects with diabetic nephropathy.~   "
205598|NCT00870376|"~     Urodynamic study is an objective method to evaluate female patients with lower urinary tract~     symptoms (LUTS). However, this method includes place a urinary catheter, thus prevents it as~     a routine method to evaluate and follow up patients with LUTS. Therefore, it is necessary to~     find a simple and objective method to help in evaluating female patients with LUTS. Several~     kinds of biomarker had been reported in diagnosing patients with overactive bladder; however,~     the sensitivity remained poor. The aim of this study is to find a useful biomarker,~     biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely~     in evaluating the female patients with LUTS.~   "
205599|NCT00870363|"~     This research study is being done to find out how the immune system in the small intestines~     improves after taking antiretroviral (anti-HIV) medications. Biopsies (small snips of tissue)~     will be taken from the part of the intestines just below the stomach, and will be studied in~     the laboratory. The main purpose of this study is to measure the increase in the numbers of~     immune cells in the intestines to see if this number is related to the amount of medication~     that reaches the intestinal tissue, and the amount of virus that is still hiding there.~      Subjects are either normal control subjects without HIV or, are HIV positive and are about to~     start HIV medications. As part of this study, HIV positive patients will be randomized to~     receive one of three possible combinations of medications.~        1. maraviroc (Selzentry) in combination with 2 NRTIs (dual nucleoside reverse transcriptase~          inhibitor) or~        2. maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse~          transcriptase inhibitor) or~        3. efavirenz (Sustiva) in combination with 2 NRTIs (dual nucleoside reverse transcriptase~          inhibitor)~      Both Maraviroc and Raltegravir each represent new classes of medications in the way that they~     interfere with HIV making copies of itself. Maraviroc attaches to the surface of the T-cell~     that the virus uses to get into the cell and is therefore known as an entry inhibitor.~     Raltegravir blocks the virus from inserting itself into the DNA of the infected cell's~     nucleus and is therefore known as an Integrase Inhibitor. We hope to learn more about how~     antiretroviral drugs affect T cells and how immune function restores itself when HIV~     infection is treated.~   "
205600|NCT00870350|"~     Open-label, randomized, multi-centre study in which 400 subjects, divided into two groups,~     will receive Td5ap or Td1aP as a single injection. We will then describe the immune response~     and safety profile of the combined vaccine booster.~   "
205601|NCT00870337|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with~     relapsed or metastatic endometrial cancer.~   "
205602|NCT00870324|"~     The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine~     episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave~     (FFRW). The performance of the lead will be measured as a difference in device-determined~     time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to~     the control group which will be randomized to receive SJM's Tendril™ RA leads.~   "
205603|NCT00870311|"~     This study investigates the effects of Lithium treatment on signal transduction pathways,~     gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It~     is hypothesized that specific changes in these markers will correlate with lithium treatment~     responsiveness.~   "
205604|NCT00870298|"~     To determine if a computerized stop order will reduce the number of concurrent~     trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic~     ordering system while a patient is hospitalized.~   "
205605|NCT00870285|"~     Ustekinumab, an IL-12/23 antibody has been approved in the E.C. and U.S.A. for the treatment~     of moderate to severe psoriasis. The aim of this study is to determine in a randomized~     half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and~     improves the clearance of skin lesions in Ustekinumab-treated patients.~   "
205606|NCT00870272|"~     This open-label, randomized study is being conducted to determine whether a dose of 400 mcg~     of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of~     mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with~     misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination~     of intrauterine pregnancy with gestational ages of <63 days will be offered the option of~     participating in the study.~   "
205607|NCT00870259|"~     The purpose of this study is to examine the effect of diet-induced weight loss on the levels~     of circulating nutrients and hormones which are involved in feelings of hunger and satiety.~   "
205608|NCT00870246|"~     The purpose of this study is to evaluate the influence of diaphragm mobility on exercise~     capacity and dyspnoea in patients with chronic obstructive pulmonary disease (COPD).~   "
205609|NCT00870233|"~     This study is being done to see if most patients are willing and able to report how they are~     feeling after surgery using the internet, and if this information can help doctors and nurses~     detect concerning symptoms after surgery.~      This study uses a special new website called WEBCORE. Patients can logon to WEBCORE and~     answer questions about how they are feeling. Then, doctors and nurses can look at this~     information during clinic appointments. We are doing this study to see if WEBCORE is a~     helpful way for us to keep track of information about how patients are feeling and quality of~     life. If WEBCORE is helpful, we will use it in the future to collect more information about~     patients' symptoms and quality of life. We can use what we learn to help find better ways of~     helping patients to prepare for what they will go through while they recover from surgery.~   "
205610|NCT00870220|"~     This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses of~     estradiol administered by recently available transdermal patches for the initiation of~     puberty in Turner syndrome girls 11.5-13.0 years old in conjunction with growth hormone (GH)~     therapy.~      The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment,~     low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating~     feminization, height velocity, and bone mineral density without compromising growth potential~     than very low dose transdermal estradiol (VLTE2), which will in turn be superior to GH alone~     in effects on feminization, height velocity, and bone mineral density.~   "
205611|NCT00870207|"~     Building on existing intervention strategies of the Tu Salud Si Cuenta media campaign, this~     proposed worksite pilot study will be testing a new feature by designing worksite promotion~     intervention strategies. The purpose of this study is to test the feasibility of a~     worksite-based physical activity and healthful food choice. The intervention will be among~     two worksites in the Lower Rio Grande Valley who employ primarily Mexican-American personnel.~   "
205612|NCT00870194|"~     The purpose of this study is to determine whether ceasing sitagliptin and switching to~     exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in~     those patients with type 2 diabetes who are experiencing inadequate glycemic control with a~     combination of sitagliptin and metformin.~   "
205613|NCT00870181|"~     Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for~     patients with these tumors remains poor despite advances in diagnosis and standard therapies~     such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy~     highlight its efficacy and safety for glioma patients. This clinical trial was conducted to~     assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of~     replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV~     administration in patients with recurrent high-grade glioma.~   "
205614|NCT00870168|"~     RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line~     chemotherapy for metastatic breast cancer.~   "
205615|NCT00870155|"~     To obtain additional safety data in subjects who have previously completed the MBP8298-01~     study A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of~     MBP8298 in Subjects with Secondary Multiple Sclerosis Dirucotide is generic name for~     MBP8298.~   "
205616|NCT00870142|"~     The purpose of this study to assess the single-dose relative bioavailability of Actavis Group~     hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fasting conditions.~   "
205617|NCT00870129|"~     The purpose of this study is to assess the ability of these advanced MRI scans in predicting~     areas within a malignant glioma (brain tumor) that are at a high risk of recurring. If these~     advanced MRI scans are able to identify the cancerous part of the tumor, then radiation~     therapy can be targeted to those sites and possibly improve patient survival.~   "
205618|NCT00870116|"~     The purpose of this study is to evaluate local disease control after 2 years in patients with~     non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy.~      Eligible patients will be recruited and registered consecutively (no randomization). The~     estimated inclusion period is approximately 24 months. The duration of the research is 4~     years.~      The number of patients required in this multicentric prospective study is 120:~        -  20 patients in the SBRT-1 arm (cyberknife),~        -  80 patients in the SBRT-2 arm (linear accelerator-based)~        -  20 patients in the conformational radiotherapy arm.~      This is a prospective, multicentric, non comparative and non randomized study.~   "
205619|NCT00870103|"~     To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is~     effective and safe for the prevention of postoperative inflammation as a consequence of~     cataract extraction surgery.~   "
205620|NCT00870077|"~     An increase in dietary protein intake has been shown to blunt the increase in intrahepatic~     fat induced by high fat feeding in healthy individuals. The purpose of this study is to~     determine if a protein supplementation decreases intrahepatic fat in obese patients with~     non-alcoholic fatty liver disease.~   "
206484|NCT00858585|"~     This study will examine genes in three different tissues and look for similarities and~     differences between normal cells and cancer cells. The tissues to be studies come from blood,~     lymph node and cancer.~   "
205621|NCT00870064|"~     Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a~     formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the~     wound is irrigated. While this is the current standard of care, not all open fractures are~     equal. In retrospective studies, centers are reporting less aggressive operative management~     for open fractures may result in equal results without the time and expense of the operative~     theater. The investigators propose a prospective, randomized trial of children with type I~     open fractures to evaluate whether formal operative treatment is necessary. The~     investigators' hypothesis is that minor open fractures can be safely treated in the emergency~     room with irrigation, closed reduction and home antibiotics without an increased risk of~     infection or other complications. Children who meet the study criteria will be randomized~     into two treatment arms - formal operative management (OR) and emergency department (ED)~     management. Outcomes from each group will be evaluated and compared, including rate of~     infection, number of return visits to the operating room, time to union, and other~     complications.~   "
205622|NCT00870051|"~     The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant~     Stent Graft System from AAA subjects.~   "
205623|NCT00870038|"~     The investigators sought to discover which one of the following strategies is the safest for~     patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous~     stent; Genous stent; drug eluting stent (paclitaxel).~   "
205624|NCT00870025|"~     There is a decline in androgen concentration with ovarian aging. Also, ovarian response to~     COH in IVF cycles diminishes with ovarian aging. Recent evidence suggest that testosterone or~     DHEA may improve ovarian response in poor prognosis patients by increasing intraovarian~     androgen concentration. A physiological way to induce androgen synthesis within the ovary is~     to stimulate theca cells androgen production by hCG stimulation. By doing this in the~     previous cycle we might expect a better response to COH.~   "
205625|NCT00870012|"~     The investigators' aim is to determine whether probiotic and prebiotic treatment plus~     lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice~     alone in patients with Nonalcoholic Fatty Liver Disease (NAFLD).~   "
205626|NCT00869999|"~     Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in~     diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose~     of this research study is to determine whether Everolimus plus rituximab is safe and~     effective in participants with relapsed or refractory DLBCL. Everolimus is an investigational~     drug that works by blocking a special protein that helps cancer cells grow. The safety and~     effectiveness of Everolimus in the treatment of DLBCL has not yet been fully determined and~     is still investigational. The other drug in this study, rituximab, is approved by the US Food~     and Drug Administration (FDA) for use in patients who have diffuse large B-cell lymphoma and~     certain other types of non-Hodgkin lymphoma. Rituximab is a drug that destroys both normal~     and cancerous B-cells.~   "
205627|NCT00869986|"~     The purpose of this study is to test if dirucotide is safe and effective in treating patients~     with relapsing remitting multiple sclerosis.~   "
205628|NCT00869973|"~     The aim of the study is to compare efficacy and tolerability of aprepitant versus~     dexamethasone in the prevention of delayed emesis induced by moderately emetogenic~     chemotherapy (cyclophosphamide plus anthracyclines) in breast cancer patients.~   "
205629|NCT00869960|"~     Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher~     amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The~     reason for this higher drug exposure has not been determined. The primary purpose of this~     study is to examine whether the pharmacokinetics (factors that determine the amount of drug~     in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women~     and ultimately result in higher amounts of drug in the body compared with men. In other~     words, we plan to examine whether changes in sex hormones throughout the menstrual cycle~     affect the amount of anti-HIV drugs in women. The antiretroviral drugs atazanavir, ritonavir,~     tenofovir and emtricitabine will be studied. This study will be conducted in healthy women~     since HIV may change the pharmacokinetics of anti-HIV drugs.~   "
205630|NCT00869947|"~     Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at~     the same speeds as non-amputees and this discrepancy is more apparent at faster walking~     speeds. Amputees choose to walk at speeds 30-40% slower than non-amputees. Preferred walking~     speed is likely influenced by elevated metabolic energy, but the underlying reason for slower~     preferred walking speeds is not fully understood. Unilateral amputees exhibit highly~     asymmetrical gait patterns that likely require more metabolic energy and impair functional~     mobility, increasing the risk of degenerative joint disease, osteo-arthritis and lower back~     pain. Improvements in prosthetic devices could enhance mobility in amputees, thus positively~     effecting rehabilitation and ambulation in veterans. A prosthesis that allows amputees to~     reduce metabolic energy would be especially useful for rehabilitation in older, ill~     individuals with reduced exercise capacities and could literally restore walking ability in~     people that are currently non-ambulatory.~      Hypotheses. Amputees wearing the Massachusetts Institute of Technology (MIT) Powered~     Ankle-Foot (PAF) prosthesis will have a lower metabolic cost, faster preferred walking speed,~     and improved gait symmetry during walking than amputees wearing a conventional prosthesis and~     will have nearly the same metabolic cost, preferred walking speed, and gait symmetry during~     walking as age, gender, height, and weight matched non-amputees.~   "
205646|NCT00869739|"~     RATIONALE: Telephone counseling after radical prostatectomy may help African American~     prostate cancer survivors and their intimate partners cope with the problems and challenges~     of surgery, and may reduce distress and improve quality of life. It is not yet known which~     counseling and education program is more effective in helping prostate cancer survivors and~     their partners.~      PURPOSE: This randomized clinical trial is studying effective ways to help African American~     prostate cancer survivors and their partners cope with challenges after surgery for~     early-stage prostate cancer.~   "
205647|NCT00869726|"~     The purpose of this study is to determine whether MBP8298 is effective and safe in the~     treatment secondary progressive multiple sclerosis.~      Dirucotide is generic name for MBP8298.~   "
205648|NCT00869713|"~     This study is designed to determine the safety and immunogenicity of an inactivated Rift~     Valley Fever (RVF) Vaccine in adults~   "
205631|NCT00869934|"~     Insomnia is a prevalent public health problem affecting large segments of the population on~     an occasional, recurrent, or chronic basis. Persistent insomnia is associated with~     impairments in daytime functioning, reduced quality of life, and increased health-care costs.~     Despite evidence that cognitive-behavior therapy (CBT) is an effective and well accepted~     treatment for insomnia, a significant proportion of individuals do not respond adequately to~     this treatment. Hence, there is a need to identify the active therapy components and~     mechanisms of change in order to develop more effective therapeutic approaches and optimize~     outcomes. The specific aims of the proposed study are to (a) evaluate the effects of~     behavioral versus cognitive therapies for insomnia and associated daytime impairment, (b)~     investigate the mechanisms of change and, (c) examine the impact of insomnia therapies on~     psychiatric conditions commonly associated with insomnia (anxiety disorders and depression).~     A sample of 186 adults with chronic insomnia will be recruited from two sites (Laval~     University and University of California, Berkeley). Participants will be randomly assigned to~     one of three groups: (a) behavior therapy (BT; n = 62), (b) cognitive therapy (CT; n = 62),~     or (c) cognitive-behavior therapy (CBT; n = 62). Measures of outcome (sleep/insomnia, daytime~     functioning) will be administered at baseline, end of treatment, and at 6- and 12-month~     follow up. Measures of mechanisms of change (maladaptive sleep habits, unhelpful beliefs,~     sleep-related worry) will be administered at baseline, after the 4th and 8th therapy~     sessions, and at the end of treatment. It is expected that (1) BT and CBT will be more~     effective for improving sleep, relative to CT, (2) CT and CBT will be more effective for~     reducing daytime functional impairment, relative to BT and (3)CT will be more effective than~     BT in reducing comorbid psychiatric disorders. The public health significance of the proposed~     study is that it will provide useful information to improve our understanding of insomnia and~     to enhance efficacy and efficiency of therapeutic approaches for a prevalent and costly~     health problem. The long-term objective is to contribute to the development and dissemination~     of evidence-based treatments for chronic insomnia and its common comorbidities.~   "
205632|NCT00869921|"~     Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of~     lead-related complications occuring during the study compared to the number of leads enrolled~     in the study. The leads will be followed for 5 years after implant. This study is required by~     FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's~     post-market surveillance platform.~   "
205633|NCT00869908|"~     This study is conducted in Africa, Asia, South America and Europe. The aim of this~     observational study is to document the experience with the study insulins when used in~     routine clinical practice. After the physician's decision to start insulin treatment using~     NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to~     be included in this study at the physician's discretion~   "
205634|NCT00869895|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of E7050 given~     orally in patients with advanced solid tumors.~   "
205635|NCT00869882|"~     This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical~     treatment at one level, aimed at comparing two approaches of spinal fusion.~   "
205636|NCT00869869|"~     The purpose of this study is to determine whether melatonin can improve sleep, quality of~     life and markers of heart failure in patients with heart failure.~   "
205637|NCT00869856|"~     This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety~     switch study involving 500 CKD subjects suffering from anemia and treated previously with a~     stable dose of ESA s.c.~      Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies~     (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.~   "
205638|NCT00869843|"~     -  To determine the depth of coagulation which is possible in human liver tissue using the~          saline linked RF Surface ablation with the Tissue Link floating ball.~        -  To determine the efficacy of the technique on surface liver tumors using saline linked~          RF surface ablati~        -  To determine a safe (non-popping upper limit) of power per area that will permit a 1 cm~          depth of tissue destruction without inflow occlusion an da 2 cm depth with inflow~          occlusion.~   "
205639|NCT00869830|"~     The aims of the investigators' study are to characterize the nature of constipation in~     idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in~     constipated IPD patients.~   "
205640|NCT00869817|"~     The purpose of this study is to identify potential biomarkers that may predict the~     development of Alzheimer's disease in people who carry an Alzheimer's mutation.~   "
205641|NCT00869804|"~     Chemotherapy for the treatment of breast cancer can affect nerves and muscles leading to loss~     of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle~     weakness. This study will explore if exercises such as walking and strength training may~     prove helpful in preventing or lessening chemotherapy-induced peripheral neuropathy from~     chemotherapy, making the therapy easier to tolerate and increasing overall quality of life.~   "
205642|NCT00869791|"~     This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066~     compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced~     Parkinson's disease.~   "
205643|NCT00869778|"~     The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus（HBV） vaccine~     (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective~     dosage and provide the rational for optimal dosing schedule.~   "
205644|NCT00869765|"~     Among antidepressant treatments, Electroconvulsive therapy (ECT) stands as the most effective~     in treating acute depression. However, patient concerns with the cognitive side effects of~     ECT have encouraged the development of new and more focal forms of brain stimulation such as~     transcranial Direct Current Stimulation (tDCS). The investigators' current study of tDCS as a~     treatment for depression suggests that this technique has antidepressant effects and is safe,~     painless and well tolerated. However, not all patients may respond to this treatment and the~     concern of possible relapse in some patients who respond to tDCS has raised interest in~     finding treatments that may enhance and prolong the antidepressant effects of tDCS. This~     study will investigate whether D-Cycloserine, a medication shown to lengthen the effects of~     tDCS on brain activity, can also enhance/prolong the antidepressant effects of tDCS in people~     suffering from depression.~   "
205645|NCT00869752|"~     RATIONALE: Monoclonal antibodies, such as MK-0646, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of MK-0646 when~     given together with etoposide and cisplatin and to see how well it works in treating patients~     with extensive-stage small cell lung cancer.~   "
205997|NCT00865072|"~     The purpose of this study is compare the relative bioavailability of 750 mg Metformin~     Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co with that of 750 mg~     GLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 750~     mg) in healthy adult volunteers under fasting conditions~   "
205649|NCT00869700|"~     Despite the clinical significance of potential interactions between antimalarials and~     antiretrovirals, no drug interaction studies have been published and there is an urgent need~     to address this gap in current knowledge.~      The aim of the study is to investigate the pharmacokinetics (PK) of antimalarial combination~     artemether/lumefantrine (AL) and combination antiretroviral therapy (cART) including~     lopinavir/ritonavir (LPV/r) in HIV-infected adults.~   "
205650|NCT00869687|"~     The primary objective of this study involves research to evaluate new collagen (the elastic~     fibers that provide skin with its strength and resilience) formation in the skin following~     injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study~     are to better understand the human skin responses to Sculptra and to assess the safety of~     Sculptra injections.~   "
205651|NCT00869674|"~     The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test~     Kit to permanent pathological section, so as to evaluate the clinical sensitivity and~     specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel~     lymph node metastases in breast cancer patients.~      The secondary objective of this trial is to evaluate the positive predictive value and~     negative predictive value of GeneSearch™ Breast Lymph Node (BLN) Test Kit when used in the~     detection of axillary sentinel lymph node metastases in breast cancer patients.~      Prospective and multi-center clinical trial~   "
205652|NCT00869661|"~     This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with~     the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily)~     (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The~     first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed~     by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC~     for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for~     12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response~     will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4~     will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36~     weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an~     open-label basis for patients of Group 5 who failed treatment. Patients will receive~     RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The~     anticipated time on study treatment is 6-12 months.~   "
205653|NCT00869648|"~     Ventilation during basic life support improves survival in cardiac arrest patients~     significantly. Unfortunately, this is in contrast to the willingness of potential rescuers to~     perform mouth-to-mouth ventilation. For example, although healthcare professionals would~     perform mouth-to-mouth ventilation on a 4-year old drowned child in >90% of cases, this~     likelihood would decrease to ~10% in the case of a young male unconscious patient in a San~     Francisco public bus. Possibly, lay rescuers would perform assisted ventilation more often if~     a simple ventilation device were available. However, both the willingness to perform assisted~     ventilation plus the ability to open and to maintain the airway patent are necessary to~     ensure efficient ventilation in an unconscious patient with an unprotected upper airway.~      Since retention of skills after basic life support classes are notoriously low, a~     resuscitation tool should incorporate self-explanatory features to improve applicability, and~     to provide built-in safety. Thus, an option could be to ensure an open airway by the use of a~     built-in indicator within a ventilating device to confirm correct head extension. One~     possible approach may be to determine head position angles that make an open airway likely,~     and integrate these angles into a scale on a ventilating device; however, safe head extension~     needs to be determined first to prevent harm.~      The purpose of this study is to determine head position angles and ventilation parameters~     reflecting neutral position, maximal extension and a position deemed optimal by an~     anaesthesiologist in patients undergoing anaesthesia induction for elective surgery in a~     first step to design a ventilating device to optimise ventilation of an unprotected upper~     airway. The investigators will ventilate 30 patients with a pillow under the head simulating~     ventilation in the operating theater, and 30 patients without a pillow under the head~     simulating ventilation during cardiopulmonary resuscitation.~      Dentures will not be removed during assessment. After anaesthesia induction the head will be~     consecutively flexed in the three positions and measurements performed. Afterwards, general~     anaesthesia and surgery will ensue. The health risk for this extra minutes of mask~     ventilation is minimal.~      The null hypothesis is that there will be no differences in head position angles and~     ventilation parameters.~   "
205654|NCT00869635|"~     In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary~     stent has been known for palliation of jaundice and improving survival. But most of~     therapeutic effects were expected to delay bile duct obstruction rather than to decrease the~     tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in~     patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the~     combined effect of photodynamic therapy and S-1.~   "
205655|NCT00869622|"~     Study Design: (e.g., Controlled, Double-Blind, Randomized, Parallel):~      Randomized, double-blind, placebo controlled of a bisphosphonate in the prevention of bone~     loss associated with the use of antiepileptic drugs.~   "
205656|NCT00869609|"~     Heart disease is a leading cause of death in people in the United States. It is a major~     problem for those with diabetes. Conditions called the metabolic syndrome and pre-diabetes~     increase risk for diabetes and heart disease. The metabolic syndrome is a group of disorders~     that occur at the same time. Overall, one in four American adults has the metabolic syndrome.~     It is more common in people over the age of 40. The metabolic syndrome includes: 1) large~     waist size, 2) high triglycerides, 3) low HDL cholesterol, 4) high blood pressure and 5) high~     fasting blood sugar. People with the metabolic syndrome have at least three of these five~     risk factors. Pre-diabetes is considered to be present in those with high fasting blood sugar~     levels below the diabetes range.~      Research has shown that type 2 diabetes and the metabolic syndrome may be prevented or~     delayed by making lifestyle changes. It is not known what will most help people continue~     these healthy changes over time. The purpose of this study is to look at ways to help people~     continue the healthy lifestyle changes they have made while taking part in a diabetes~     prevention program called Group Lifestyle Balance (GLB).~   "
205657|NCT00869596|"~     This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory~     mediators measured in sputum of healthy volunteers following exposure to inhaled~     lipopolysaccharide.~   "
205658|NCT00869583|"~     Obesity is a serious health problem among Mexican American women. Obesity combined with a~     lack of physical activity can increase the risk for several diseases, including heart~     disease. This study will evaluate a program that aims to increase physical activity levels~     among women of Mexican origin in Columbia, South Carolina and the Lower Rio Grande Valley of~     Texas.~   "
205667|NCT00869466|"~     RATIONALE: Measuring changes in body weight and body composition in women with early-stage~     breast cancer may help doctors plan the best weight control program and improve patients'~     quality of life. It is not yet known which program is most effective in women with breast~     cancer.~      PURPOSE: This randomized clinical trial is comparing three weight control programs to see how~     well they work in women who have undergone surgery for early stage breast cancer.~   "
205659|NCT00869570|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the tumor. Giving radiation therapy together with capecitabine and sorafenib before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine~     when given together with sorafenib and external-beam radiation therapy and to see how well it~     works in treating patients with locally advanced rectal cancer.~   "
205660|NCT00869557|"~     The objective of this double-blinded, multicenter, randomized, active-controlled study is to~     evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed~     doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir~     disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected,~     antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for~     patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs.~      Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization~     will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at~     screening. After Week 48, participants will continue to take their blinded study drug and~     attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which~     point all participants will attend an Unblinding Visit and be given the option to participate~     in an open-label rollover extension (the extension is scheduled to be open until Stribild~     becomes commercially available, or until Gilead Sciences elects to terminate the study).~   "
205661|NCT00869544|"~     A. Statement of Hypotheses:~      HIV-infected patients have an increased incidence of emphysema compared to non-HIV-infected~     smokers, and it has been hypothesized that this accelerated disease progression is the result~     of one or more latent infections that amplifies the pulmonary inflammatory response to~     cigarette smoke. Pneumocystis is one infectious agent that likely plays a key role in the~     development of HIV-associated emphysema. Colonization with Pneumocystis has been demonstrated~     in HIV-infected subjects, and HIV-infected smokers are particularly susceptible to Pc~     colonization regardless of CD4 cell count or use of prophylaxis. Pneumocystis colonization is~     also increased in non-HIV-infected patients with chronic obstructive pulmonary disease (COPD)~     and is directly related to the severity of the disease. The presence of Pneumocystis in the~     lungs, even at low levels as seen in colonization, produces inflammatory changes similar to~     those seen in COPD, with increases in the numbers of neutrophils and cytotoxic CD8+~     lymphocytes. We propose that Pneumocystis accelerates emphysema in HIV-infected smokers by~     stimulating inflammation and tissue destruction. We will examine the role of co-infection~     with Pneumocystis in the pathogenesis of HIV-associated emphysema and the mechanism by which~     it causes emphysema progression. These studies will lead to information that will provide a~     rational basis for prevention and therapy of HIV-associated emphysema and provide a model for~     emphysema in the general population~   "
205662|NCT00869531|"~     The aim of this study is to investigate the potential beneficial effect of wholegrain on body~     weight and composition as well as cardiovascular risk in overweight women.~   "
205663|NCT00869518|"~     DESIGN: This single center, double-blinded, randomized phase II study is being conducted to~     assess the efficacy of a rifabutin based regimen to eliminate S. aureus colonization in HIV~     infected individuals. Individuals must have HIV infection and a skin and skin structure~     infection (SSSI) in the prior 6 months to be eligible for screening. Prior to enrollment,~     subjects will be cultured for evidence of S. aureus colonization. Individuals who are culture~     positive at ≥ one body site will be eligible for enrollment. Subjects who meet inclusion and~     exclusion criteria and consent to participate in the study will be randomized to seven days~     of rifabutin plus trimethoprim-sulfamethoxazole (TMP-SMX) or TMP-SMX alone. Following~     completion of treatment subjects will be screened seven days, 30 days, and 60 days~     post-treatment for colonization at multiple body-sites. Subjects will also be actively~     followed for evidence of SSSI.~      SUBJECT PARTICIPATION DURATION: 12 weeks~      SAMPLE SIZE: 88 total subjects~      POPULATION: 200 HIV infected individuals who receive care at San Francisco General Hospital~     HIV clinic (Ward 86) with a history of SSSI in the prior 6 months will be screened for S.~     aureus colonization.~      DESCRIPTION OF AGENT OR INTERVENTION: This is a double-blind trial comparing rifabutin plus~     TMP-SMX versus placebo plus TMP-SMX. Placebo will be administered at a dose of 300 mg p.o.~     daily or an equivalent dose depending on co-administration of other drugs that may adjust the~     serum level of rifabutin. TMP-SMX will be administered at a dose of trimethoprim 160 mg and~     sulfamethoxazole 800 mg p.o. twice daily or adjusted per CrCl. Study drug will be provided by~     the study and administered for 7 days.~   "
205664|NCT00869505|"~     Memantine is a glutamate receptor antagonist that has been reported to reduce~     Obsessive-Compulsive Disorder (OCD) symptoms in case studies of treatment-resistant~     individuals. The investigators hypothesized that memantine is an effective augmenting agent~     to standard intensive residential treatment of severe OCD. An intent-to-treat,~     single-blinded, naturalistic case-control design is employed. The sample includes subjects~     receiving standard treatment at the McLean/ MGH Intensive Residential Treatment (IRT)~     program, half of whom also receive memantine augmentation. Admission, monthly and discharge~     measures of OCD, depression and psychosocial functioning are collected by raters blinded to~     augmentation status. Matched controls are selected based upon gender, initial OCD severity,~     psychosocial functioning, and timing of admission. Descriptive and comparative analyses are~     conducted via SPSS, statistical significance is defined at p<0.05, clinically significant~     response is defined by a 25% reduction, and 'marked response' is defined by a 50% improvement~     in Yale-Brown Obsessive Compulsive severity (Y-BOCS) scores, using a~     last-observation-carried-forward approach. The Clinical Global Improvement (CGI) scale~     captures global clinical change.~   "
205665|NCT00869492|"~     The purpose of this study is to determine whether using of nadifloxacine 1% cream and benzoyl~     peroxide 5% solution together is more effective than using nadifloxacine alone in the~     treatment of mild to moderate facial acne.~   "
205666|NCT00869479|"~     The Primary Aim of this study is to validate a questionnaire as a screening tool to identify~     subjects with symptoms suggestive of nephrogenic systemic fibrosis (NSF). The investigators~     believe that there will be difference between subjects with NSF and other skin conditions and~     normal skin.~   "
205668|NCT00869453|"~     The role of gut hormone (GLP-1, GIP, PYY...) in glucose homeostasis has been widely~     demonstrated. Furthermore modifications in their pattern of secretion seem to be involved in~     the improvement of glucose control in obese patients after bariatric surgery.~      The purpose of this study is to assess the respective role of carbohydrate, fat and protein~     from a complete meal in gut hormones secretion.~   "
205669|NCT00869440|"~     The purpose of this study is to assess the safety and efficacy of CNS 7056 as a procedural~     sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.~   "
205670|NCT00869427|"~     After spinal cord injury, patients have frequent urinary tract infections (UVI). Vitamin C is~     usually prescribed to prevent such infection, but the efficacy of the treatment is poorly~     documented. In the study, patients will be randomised either to receive vitamin C daily, or~     not, for one year, and clinical episodes of UVI will be registered. The null hypothesis is~     that vitamin C will not reduce the number of UVI episodes by 30%.~   "
205671|NCT00869414|"~     This research is a prospective, randomized, cross-over study that is being done to compare~     the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on~     hypoglycemia (blood glucose level <70 mg/dL) as measured by continuous glucose monitoring~     (CGM) in patients with type 1 diabetes.~   "
205672|NCT00869401|"~     Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. This randomized phase I/II trial is studying the~     best dose of dasatinib and to see how well it works compared with a placebo when given~     together with radiation therapy and temozolomide in treating patients with newly diagnosed~     glioblastoma multiforme.~   "
205673|NCT00869388|"~     This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly~     to patients with solid tumors.~   "
205674|NCT00869375|"~     The purpose of this study is to compare the effects (positive and negative) of two different~     devices available to treat people with critical limb ischemia, which involves a sudden~     decrease in blood flow to the leg that causes a potential threat to the limb and causes pain~     at rest, ulcers or gangrene.~      One device is the Clearway balloon, which delivers a drug to dissolve the clot where the~     blockage is. The other device is the Angiojet, which removes the clot in a mechanical way~     (vacuum effect). This research is being done because currently there is no single proven~     effective treatment for this condition. Even though, both these devices are commonly used in~     the clinical practice to treat critical limb ischemia, there are no studies that compare~     these devices and help us see which one may be better for these patients.~   "
205675|NCT00869362|"~     The hypothesis of this study is that using hospital admission to identify patients with~     poorly controlled diabetes (hemoglobin A1c levels >8%), and intervening during the~     hospitalization with targeted inpatient diabetes management will improve glycemic control at~     3 and 12 months, with inpatient glycemic control, quality of life, and diabetes self-efficacy~     serving as secondary endpoints.~   "
205676|NCT00869349|"~     The purpose of the Living Well with RA program is to perform a proof-of-concept study and~     evaluate the efficacy of an Internal Family Systems-based psychotherapeutic intervention~     improve Rheumatoid Arthritis subjects' disease activity, independence and other health~     outcomes. This study will also assess the efficacy of an IFS-based program in improving RA~     subjects' mental health symptoms. We hypothesize that the IFS model will improve RA subjects~     self-management of their disease and subsequently their health outcomes will improve as well~     as compared to a group focusing on arthritis education.~   "
205677|NCT00869336|"~     To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or~     28 days to achieve complete clearance at 2 weeks post treatment.~   "
205678|NCT00869323|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such~     as rituximab, can block cancer cell growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Giving bortezomib together with rituximab may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab~     works in treating patients with post-transplant lymphoproliferative disorders.~   "
205679|NCT00869310|"~     The aim of the study is to compare efficacy and tolerability of aprepitant plus dexamethasone~     versus metoclopramide plus dexamethasone in the prevention of cisplatin-induced delayed~     emesis in patients that received aprepitant, palonosetron and dexamethasone before~     chemotherapy administration for the prevention of acute emesis.~   "
205680|NCT00869297|"~     Fluid management of surgical patients has changed dramatically in recent years. Recent~     studies have shown that so called 'restrictive' fluid strategies can improve outcomes such as~     length of stay and time to fitness for discharge. Furthermore, new monitoring technologies~     have been developed that allow the clinician to better monitor the effects of intravenous~     fluid therapy.~      The fluid management of free flap reconstruction surgery is controversial. As vasoactive~     agent use during the anesthetic is not the preferred intervention for the treatment of~     hypotension, fluid therapy is often administered to correct hemodynamic instability. A~     liberal fluid strategy may predispose the flap to edema, venous congestion and ultimately~     flap failure. A restrictive fluid strategy however has (at this institution) anecdotally been~     reported to lead to a higher incidence of deep venous thrombosis (DVT) and pulmonary embolus~     (PE). Thus, there is clinical equipoise as to the optimal fluid management for these~     patients.~      Non-invasive cardiac output (CO) monitoring based on the arterial pulse contour is a nascent~     technological advance that has been widely validated in the operating theatre. The~     calculation of CO is based on the assumption that stroke volume is proportional to the~     integral of the area under the arterial pressure versus time curve. With these monitors, the~     variation in stroke volume during mechanical ventilation is also calculated and this can be~     utilized as an estimate of the patient's volume status. A stroke volume variation (SVV) of~     less than 15% has been shown to be indicative that a patient is no longer volume responsive.~      In our study, we plan to recruit patients undergoing microvascular free flap reconstruction.~     Patients will be randomized to either standard care, or goal directed fluid therapy.~      All patients will receive a pre-operative 5 ml kg-1 bolus of normal saline. Subsequently, all~     patients will then receive lactated ringers at a rate of 5 ml kg-1 hr-1. Patients in the~     intervention group will have their CO and SVV monitored by a Flo-Trac pulse contour monitor~     (Edwards Life Sciences, Irvine, CA). Patients in the intervention group will receive 6%~     tetrastarch boluses (Voluven, Fresenius Kabi, Hamburg, Germany) if their SVV exceeds 15%.~     Patients in the control arm will receive fluid at a rate and type at the discretion of the~     attending anesthesiologist to maintain hemodynamic stability and a urine output of 0.5 ml~     kg-1 hr-1.~      Intra-operative variables studied will include total fluid administered (colloid and~     crystalloid), urine output, SVV and CO (both at the start and end of surgery). Postoperative~     variables examined will be urine output, daily fluid balance (days 0-3), incidence of DVT,~     PE, pulmonary edema, rate of re-operation, daily serum creatinine, chloride and bicarbonate~     concentration, and incidence of flap failure.~      Measurements of flap oxygenation and water content will be made with near infrared~     spectroscopy at baseline, and during the immediate post-operative period (days 1-7).~      We hypothesize that the goal directed group would have more intra-operative colloid given~     with a reduced incidence of adverse outcomes.~   "
205681|NCT00869284|"~     Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3~     untreated aggressive NHL.~   "
205682|NCT00869271|"~     The purpose of this study is to investigate whether TAC plus FOLFOX4 are able to improve~     resection rate and overall survival in patients receiving primary colorectal tumor resection~     than given FOLFOX4 only.~   "
205683|NCT00869258|"~     The purpose of this study is to determine whether an experimental drug combination consisting~     of Gemzar®, Taxotere®, and Xeloda®, (called GTX) when followed by radiation therapy plus~     low-dose Gemzar, is safe and effective in treating advanced pancreatic cancer and to study~     and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.~   "
205684|NCT00869245|"~     The purpose of this study is to investigate the best way to evaluate patients with chest pain~     in the emergency department. It compares types of cardiac tests performed while receiving~     treatment in an observation unit. Patients will either undergo cardiac MRI testing or~     conventional care testing. Patients treated in the conventional care testing group will~     undergo the testing their doctor determines is best for them. All patients will undergo~     follow up to find out if they have had any heart related events.~   "
205756|NCT00868296|"~     The purpose of this study is to provide additional information on safety and tolerability~     after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331~     study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this~     study.~   "
205685|NCT00869232|"~     There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma~     at the MIRT from 1989 to present. Results have shown that participants treated on these~     studies had better outcomes (meaning they have lived longer and had better responses to~     treatment) when compared to individuals treated with standard chemotherapy.~      Past studies conducted at the MIRT and at other institutions have shown that participants~     with high-risk features by gene array studies tend to have shorter remissions (disappearance~     of signs and symptoms of myeloma) and do not survive as long as participants with low-risk~     myeloma. Researchers at MIRT think that one reason for this is that the myeloma cells re-grow~     in the time when participants are not receiving treatment because they are recovering from~     high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs~     previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is~     hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow~     between cycles, therefore resulting in longer remissions. This study is being done in an~     attempt to improve the remission rate and the survival time for participants with high-risk~     myeloma.~   "
205686|NCT00869219|"~     Different case reports are showing that depending on the drug used for eye drops, it might~     provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This~     study is intended to provide information about this parameter concerning these two drugs.~   "
205687|NCT00869206|"~     This randomized phase III trial studies two different schedules of zoledronic acid to compare~     how well they work in reducing bone-related complications in patients with breast cancer,~     prostate cancer, or multiple myeloma that has spread to other places in the body and have~     bone involvement. Bone-related complications are a major cause of morbidity in patients with~     metastatic prostate cancer, breast cancer, and multiple myeloma. Zoledronic acid may stop the~     growth of cancer cells in the bone and may help relieve some of the symptoms caused by bone~     metastases. It is not yet known whether giving zoledronic acid more or less frequently is~     more effective in treating patients with metastatic cancer that has spread to the bone.~   "
205688|NCT00869193|"~     The purpose of this study is to determine whether an 8-week intervention with grape seed~     extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal~     female with elevated daytime blood pressure values.~   "
205689|NCT00869180|"~     The primary purpose of this study is to assess the effectiveness of once daily application of~     a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle~     sprains when applied to the painful area.~   "
205690|NCT00869167|"~     This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on~     patients with insomnia comorbid with asthma.~   "
205691|NCT00869154|"~     The aim of the study is to compare a multidisciplinary examination and follow up by~     rehabilitation program with a multidisciplinary examination, good advice and follow up by the~     family doctor.~      Further on we will examine if there were differing clinical characteristics between patients~     who attended a planned follow-up session and those that failed to and Prognostic factors in~     mild traumatic brain injury patients after discharge from hospital.~   "
205692|NCT00869141|"~     The purpose of this study is to compare the occurrence rate of the high pressure phase and~     the final pressure outcomes between patients treated with glaucoma medication prior to the~     expected onset of the high pressure phase to those patients who have glaucoma medication~     started at the onset of the high pressure phase. The investigators hypothesize that if~     glaucoma medications are started prior to the expected onset of high pressure phase, the high~     pressure phase will not occur as frequently and the ultimate pressure level will be lower~     than if the glaucoma medications are started at the onset of this phase.~   "
205693|NCT00869128|"~     Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and~     suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on~     glucose lipid metabolism and sleep is studied in type 2 diabetes patients with insomnia.~   "
205694|NCT00869115|"~     This study explores a potential drug-drug interaction between istaroxime and digoxin in~     patients with stable CHF on chronic oral digoxin treatment.~   "
205695|NCT00869102|"~     The purpose of this study is to characterise beta cell function in subjects who despite~     taking part in a diabetes prevention program (life style intervention with diet and exercise)~     exhibit impaired glucose tolerance and beta cell dysfunction.~   "
205696|NCT00869089|"~     This trial will include:~        -  Study period up to 7 months.~        -  Office visits monthly lasting approximately 1 hour.~        -  Blood Draws.~        -  Oral medication that is taken 2 times daily.~        -  Photographs and biopsies if agreed.~   "
205697|NCT00869076|"~     The hypothesis is that patients with poorly controlled diabetes would have greater~     improvement in their blood sugar control when managed by a clinical pharmacist than when~     managed with usual medical care. Patients with poor control are randomized to pharmacist~     management or to usual medical care for one year.~   "
205698|NCT00869063|"~     The purpose of the study is to assess the effectiveness of once daily application of a~     diclofenac sodium topical patch in reducing acute pain due to mild to moderate wrist sprain,~     strain or contusion when applied to the painful area.~   "
205699|NCT00869050|"~     This phase II study is designed to assess whether treatment with capecitabine/temozolomide~     (CAP/TEM) is safe and effective in treating subjects with progressive, differentiated,~     metastatic neuroendocrine tumors (NET). The primary objective of the study is to determine~     the radiologic response rate to this regimen in progressive, metastatic, differentiated~     neuroendocrine cancers.~   "
205700|NCT00869037|"~     The recovery from knee replacement surgery often involves a significant amount of pain. The~     best way to prevent/treat this pain is unknown. This study will compare two accepted methods~     of pain control in order to determine which is superior. The first method involves the~     injection of a solution containing multiple medications into the knee joint at the time of~     surgery. The second method involves the placement of a catheter adjacent to the femoral nerve~     which senses pain from the knee. This catheter is used to deliver local anesthetic which~     serves to block the transmission of pain signals from the nerve. The catheter will be left in~     place until 2 days after surgery. This method is combined with injection of local anesthetic~     in a particular area of the knee joint at the time of surgery. Patients will be followed~     until 2 days after surgery in order to determine which method is superior. We believe the~     second method will be deemed superior.~   "
205701|NCT00869024|"~     The purpose of this study is to determine if the delivery of cells just after implantation of~     left ventricular assist device will help to improve the pumping function of your heart and~     minimize heart enlargement in the future.~      The cells will be obtained by aspiration or withdrawal of fluid from your bone marrow from~     your pelvic bone using a needle and syringe. This would not take place until 24-48 hours~     prior to your planned left ventricular assist device implantation. During the surgery the~     surgeons will inject the prepared cells that were taken from your bone marrow and inject it~     into your heart muscle.~      This study will test whether receiving your own bone marrow cells directly into your heart~     will help your heart to recover function after placement of a left ventricular assist device.~   "
205702|NCT00869011|"~     In this randomized, controlled trial the investigators evaluate the effects of an exercise~     program lasting for 12 weeks on the physical performance, the cardiovascular function (24h~     blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients~     with renal cell carcinoma undergoing a therapy with Sunitinib.~   "
205703|NCT00868998|"~     This is a study for patients with advanced cancer of the biliary tree, such as~     cholangiocarcinoma. They will be treated with a chemotherapy regimen consisting of~     Gemcitabine, Taxotere, and Xeloda every 21 days for at least 9 weeks. Treatment will continue~     until their cancer progresses. This chemotherapy regimen has been used in pancreatic cancer~     and there is reason to believe that it will be effective for cancers of the biliary tree as~     well.~   "
205704|NCT00868985|"~     The study is to evaluate the influence of three different doses of PEG 3350 with or without~     electrolytes on the electrolyte balance in patient volunteers with confirmed chronic~     constipation.~   "
205705|NCT00868972|"~     Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal~     function, refractory hypertension and flushing edema, responsible for mortality and~     morbidity, especially in the elderly. Current treatment includes restoration of the renal~     arterial lumen by endovascular stent placement and/or intensive medical therapy. There is no~     unanimous consent on which patients could benefice of the endovascular procedure due to the~     high rate of renal adverse events especially linked to atheroembolic disease. Recently, renal~     revascularization using a device which consents distal embolic protection of the kidney~     demonstrated to be a safe auxiliary procedure in a few non randomized studies.~     Interestingly atheromatous debris was detected in 60 to 80% of these devices analyzed after~     the procedure suggesting that these devices could prevent atheroembolism in a substantial~     proportion of patients. On the other hand, only a randomized controlled study can prove that~     renal stent with distal embolic protection is superior to renal stent alone in preserving~     kidney function.~      Therefore, the present study aims to compare the effects of renal artery stent placement with~     or without distal embolic protection on renal function in ARAS patients.~      Method:~      Patients with an ARAS of ≥70% and hypertension not responsive to at least 2 antihypertensive~     medications and/or renal failure (estimated GFR <60 mL/min/1.73 m2 are randomly assigned to~     stent placement alone or stent placement with distal embolic protection (FILTER WIRE EX;~     Cordis Endovascular, USA).~      Other medications consist of statins, anti-hypertensive drugs and antiplatelet therapy.~     Patients are followed for 3 months. The primary outcome of this study is a statistical~     significant difference in kidney function measured as Cr clearance and cystatin C level in~     the 2 groups at three months. The trial will include 150 patients.~   "
205706|NCT00868959|"~     This clinical study is designed to test the hypothesis that lurasidone is effective,~     tolerable, and safe for the treatment of patients with bipolar I depression~   "
205707|NCT00868946|"~     This is a treatment protocol using IND Ribavirin-there is no control group. Hemorrhagic Fever~     with Renal Syndrome (HFRS) is caused by a virus acquired by contact with chronically infected~     rodent hosts. HFRS is present throughout Europe and caused mainly by Puumala and Dobrava~     viruses. Treatment consists mainly of supportive care with careful attention to control of~     blood pressure and fluid balance and/or dialysis. Early initiation of IND Intravenous~     Ribavirin has been shown to be an effective treatment for HFRS and may prevent the need for~     dialysis. It is important to initiate therapy based on a diagnosis consistent with HFRS~     (determination if the disease is caused by Puumala or Dobrava virus is helpful) and a history~     that makes exposure likely. This study will monitor the clinical events that occur with HFRS~     as well as the safety and efficacy of Ribavirin.~   "
205708|NCT00868933|"~     Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent~     countries. It may progress to cirrhosis and liver cancer. At present, there is no approved~     drug for NAFLD. Although healthy diet and exercise is often recommended, there is little~     supportive evidence. Therefore, the investigators plan to conduct a randomized controlled~     trial comparing a low glycemic index dietary intervention program and simple lifestyle advice~     in NAFLD patients. The primary endpoint is resolution of NAFLD. Non-invasive tests will be~     used to assess the study subjects. Proton-magnetic resonance spectroscopy is used to quantify~     hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis.~   "
205709|NCT00868920|"~     The purpose of this study is to see whether patients controlling their own sedation during~     colonoscopy are less likely to need help breathing than when an anesthesiologist controls the~     medicine, and whether we can predict when the need for help will occur. The pump used in the~     study is approved for clinical use by the FDA, as are the medicines used in the pump.~   "
205710|NCT00868907|"~     Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to~     17-day washout period between doses. The study will consist of a screening visit, study~     center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each),~     1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures.~   "
205711|NCT00868894|"~     To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering~     intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma~     or ocular hypertension.~   "
205712|NCT00868881|"~     Non-interventional,observational and retrospective study assessing the therapeutic and~     diagnostic attitude followed in primary care for a hypertensive patient depending on his~     degree of blood pressure control.~   "
205713|NCT00868868|"~     A randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in~     prostate cancer patients treated with androgen deprivation therapy. The investigators want to~     demonstrate if there are less side effects of hormonal therapy and better quality of life in~     patients who made regular exercise.~   "
205815|NCT00867529|"~     This phase II trial studies giving rituximab before and after a donor peripheral blood stem~     cell transplant in patients with B-cell lymphoma that does not respond to treatment~     (refractory) or has come back after a period of improvement (relapsed). Monoclonal~     antibodies, such as rituximab, can interfere with the ability of cancer cells to grow and~     spread. Giving rituximab before and after a donor peripheral blood stem cell transplant may~     help stop cancer from coming back and may help keep the patient's immune system from~     rejecting the donor's stem cells.~   "
205714|NCT00868855|"~     Coronary artery disease is the leading cause of death in USA. Contemporary cardiac care has~     substantially reduced mortality and morbidity in patients with severe coronary artery~     disease. However, patients with mild to moderate coronary artery stenosis (<70% stenosis)~     often present in the future with life threatening acute coronary syndrome which carries~     significant mortality and morbidity. It is difficult to predict outcomes in these patients~     before the events because the lack of complete understanding of the mechanisms underlying~     acute coronary syndrome and the lack of reliable markers that will predict major adverse~     cardiac events (MACE). Tissue-type plasminogen activator (t-PA) is released from endothelial~     cells and a major factor that prevent thrombosis in the coronary artery, the cause of acute~     coronary syndrome. Endothelial dysfunction impairs t-PA release. Therefore, we hypothesize~     that patients with impaired coronary artery t-PA release will have significantly higher risk~     for future MACE due to intrinsic fibrinolytic dysfunction that leads to increased thrombosis~     risk.~      To test this hypothesis, we will determine whether intrinsic endothelial fibrinolytic~     dysfunction predicts MACE in patients with non-significant CAD. The study will measure t-PA~     release mediated by bradykinin, a major mediator for t-PA release. This will involve infusion~     of bradykinin into left main coronary artery of individuals who have undergone routine~     cardiac catheterization (clinically indicated). We will take blood samples from the coronary~     sinus and measure t-PA and plasminogen activator inhibitor-1 antigen and activity levels.~   "
205715|NCT00868842|"~     This is an open-label, single-center study of whether oral penicillin desensitization of~     healthy sensitive subjects results in allergen cross-desensitization of mast cells by skin~     testing and desensitization of peripheral blood basophils. The primary endpoint(s) will be~     PC3 prick skin test values to penicillin, aeroallergen(s) and codeine. Secondary endpoints~     will be levels of Syk in purified basophils determined by flow cytometry (mean fluorescence~     intensity) and basophil degranulation (% tryptase release) to anti-FcåRI and to calcium~     ionophore.~   "
205716|NCT00868829|"~     The experimental design is a multi-center, prospective, non-controlled, non-randomized,~     single-arm clinical registry trial. The study will enroll 5,000 patients who receive the~     Firebird2TM Cobalt-ChromiumAlloyed Sirolimus-Eluting Stent implantation. For patient with~     multivessel disease, only Firebird 2TM Stent will be implanted. The enrollment of patients~     will take about 4 months. Clinical follow-up will be at 30 day, 6 month, 12 month, 24 month~     and 36 month. Patients withdrawing the study due to any reasons will not be replaced.~   "
205717|NCT00868816|"~     The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles~     or 12 cycles) is better for patients receiving curative colorectal cancer resection.~   "
205718|NCT00868803|"~     The goal of the study is to gain a better understanding of the molecular changes responsible~     for causing prostate cancer and that examination of tissue and blood samples will help in the~     development of improved screening and therapeutic approaches.~   "
205719|NCT00868790|"~     This study assessed the safety and efficacy of MK-3577. The primary efficacy hypothesis was~     that, after 4 weeks of treatment, either the morning (AM) administration or the evening (PM)~     administration of MK-3577 provides superior reduction of 24-hour weighted mean glucose (WMG)~     levels compared to placebo (PLA). The primary safety hypothesis was that MK-3577 is well~     tolerated compared to placebo.~   "
205720|NCT00868777|"~     The hypothesis of this study is that there is a significant difference in bone maturation~     after sinus grafting determined by the distance from the buccal to the palatal wall of this~     cavity.~   "
205721|NCT00868764|"~     This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of~     Sancuso®.~   "
205722|NCT00868751|"~     The purpose of this study is to see if tocilizumab is safe and effective for treating~     systemic onset Juvenile Idiopathic Arthritis (soJIA). Another purpose is to see if~     tocilizumab helps reduce the amount of steroids (prednisone) needed to control symptoms of~     soJIA.~   "
205723|NCT00868738|"~     The goal of our research is to provide data to enhance the development of nutritional~     guidelines, especially as related to mineral nutrition, in children. Using human~     experimentation, we are studying methods of delivering the key minerals of calcium, zinc and~     iron in the diet so as to optimize health outcomes. We will conduct a controlled trial of~     vitamin D supplementation to assess the effects of vitamin D status on calcium absorption in~     small children. We will evaluate the effects of differing intakes of zinc on zinc and copper~     absorption. These studies will utilize stable isotope techniques so as to provide accurate,~     practically applicable information which may be obtained from the study populations in a safe~     manner. These data will have global application and provide a strong basis for evidence-based~     nutritional recommendations to be developed.~      Objective #1: To evaluate the effects of supplemental vitamin D in enhancing calcium~     absorption in healthy children 4 to 8 yrs of age.~      Objective #2: Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of~     age.~   "
205724|NCT00868725|"~     Previous studies indicate that there are significant differences in the temperature of tumors~     and normal, adjacent tissues. The present study will test this hypothesis for lesions in the~     oral cavity. Thermal images of the oral cavities of patients, undergoing examination in the~     Department of Oral and Maxillofacial Surgery of Sheba hospital, will be compared to the~     diagnoses of the examining doctors. The results, apart from enhancing the delineation of oral~     cavity tumors, may help the decision to develop miniature thermal cameras to scan thermally,~     the GI tract.~   "
205725|NCT00868712|"~     The purpose of the study is to assess whether the use of warfarin, a commonly used~     anticoagulation drug, is associated with increased amounts of coronary artery calcification.~     Studies in animals and preliminary but small retrospective studies in humans have suggested a~     possible link to increased tissue calcification with use of this drug. The researchers will~     investigate this by assessing the amount of calcification seen in the coronary arteries using~     a specialized computed tomography (CT) scan (electron-beam CT) and assessing to see if the~     amount is influenced by the amount of time a patient has been taking warfarin. The~     researchers will exclude patients with known coronary artery disease, chronic kidney disease~     or hyperparathyroidism.~   "
205726|NCT00868699|"~     This clinical study is designed to test the hypothesis that lurasidone is effective,~     tolerable, and safe for the treatment of patients with bipolar I depression~   "
206485|NCT00858572|"~     The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib)~     in subjects with hematologic malignancies.~   "
205727|NCT00868686|"~     In most cases of acute mallet finger, or avulsion of the extensor digitorum communis terminal~     tendon from the distal phalanx, splinting is the treatment strategy employed. The type of~     splint used to treat these injuries continues to be controversial. Custom splints have~     recently been advocated though no strong comparative evidence is available.~      The primary objective of this investigation was to show superiority of the custom~     thermoplastic splint over both the dorsal and volar non-custom splints. The null hypothesis~     was that a radiographic lag difference greater than 5 degrees would not be observed between~     groups. The primary outcome measure is the residual extensor lag difference (compared to the~     contralateral equivalent digit) at 12 weeks post-splinting.~   "
205728|NCT00868673|"~     The purpose of this study is to determine if a low fructose intake could have an impact on~     weight loss, uric acid levels and the components of the metabolic syndrome (glucose,~     cholesterol, triglycerides, insulin resistance, high blood pressure).~   "
205729|NCT00868660|"~     Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose~   "
205730|NCT00868647|"~     This is a single-center, Phase II study including only patients on whom a decision to conduct~     radiofrequency ablation (RFA) has already been made. The primary objective of this study~     assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6~     and 12 months following RFA for the benign lesions.~      RFA is an imaging guided percutaneous or intra-operative procedure that uses a probe on the~     end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by~     heating the probe (using an electrical current alternating at radio frequency) which raises~     the temperature of the tumor potentially causing irreversible cell death.~      RF ablation is an alternative for local tumor control when other treatments (surgery,~     radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). Thermal~     ablation at times is the only remaining alternative for patient cure, prolonged survival or~     palliation. Cryotherapy, and microwave, laser and focused ultrasound are alternative thermal~     ablation techniques used in adults but there has been no experience in children with these~     alternative methods.~      To be eligible for this study, patients must have acquired lesions at < 21 years of age~     (central nervous system lesions are excluded from this study). Study participants will have~     the RFA procedure performed at Seattle Children's and will have follow-up evaluations at~     various time points post-RFA.~   "
205731|NCT00868634|"~     The aim of the trial is to detect the superiority of the triple combination of capecitabine,~     bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in~     patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are~     treated until progression of disease to determine PFS.~   "
205732|NCT00868621|"~     Overactive bladder (OAB) is a widespread condition characterized by urgency, urge~     incontinence, nocturia and excessive urinary frequency, affecting millions of people~     worldwide.(1) In two epidemiological studies, OAB was found in about 17% of American and~     European populations.(2)(3). This accounts for an estimated 33 million patients suffering~     from OAB in the USA. The disorder constitutes a psychological stress that impacts the~     patient's social life.~   "
205733|NCT00868608|"~     The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in~     subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after~     multiple therapies including rituximab or radioimmunotherapy. The investigational drug will~     be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every~     4 weeks.~   "
205734|NCT00868595|"~     This is a Phase I, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety,~     pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of~     therapeutic vaccine, BPX-101 (formerly BP-GMAX-CD1), plus activating agent, AP1903, in~     patients with castrate resistant prostate cancer.~   "
205735|NCT00868582|"~     The Centers for Medicare & Medicaid Services (CMS), as the Federal agency that administers~     the Medicare program, only pays for positron emission tomography (PET) scans in patients with~     cancer for certain reasons and for certain types of cancer. This study was developed to help~     CMS determine if they should pay for PET scans for additional reasons and additional types of~     cancer. In order to collect the information needed to decide which other types of cancer~     should be covered by Medicare, CMS will provide payment for the otherwise non-covered PET~     scans of patients who are properly registered with the National Oncologic PET Registry~     (NOPR). This information will then be analyzed to determine the effect PET scans had on the~     way physicians planned to treat their patients.~   "
205736|NCT00868569|"~     The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are~     able to improve resection rate and overall survival in patients receiving primary colorectal~     tumor resection than given FOLFOX4 only.~   "
205737|NCT00868556|"~     This is a 2 visit research study for patients with or without a diagnosis of migraine.~     Participants will be administered informed consent, have a medical history taken and a~     physical examination performed, and complete 3 questionnaires at the first visit. The~     participants will have a functional MRI performed after completion of Visit 1. Study stipends~     will be given for each completed research visit.~      The purpose of this study is to potentially identify risk factors and/or biomarkers (which~     are differences in the brain structures)by comparing the brain MRI scans of migraine~     sufferers to brain scans of control persons to attempt to identify migraine progression using~     the functional MRI scans.~   "
205738|NCT00868543|"~     The goal of this study is to compare the clinical efficacy (weight loss and metabolic~     changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in~     superobese (BMI>50) patients.~   "
205739|NCT00868530|"~     This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in~     Chinese hemophilia A subjects.~   "
205740|NCT00868517|"~     The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic~     Stress Disorder sleep difficulties among veterans who participated in Operations Enduring~     Freedom and Iraqi Freedom. This study also examined the degree of veteran acceptance for a~     group ear acupuncture procedure.~   "
205816|NCT00867516|"~     The purpose of this study is to determine the safety and efficacy of ALD518 in three~     different doses in patients who have not had an adequate response to methotrexate.~   "
207378|NCT00846716|"~     The purpose of this study is to investigate whether the oral anti-diabetic drug, Thiazolidine~     (TZD) is effective in suppression of onset or progressin of diabetic nephropathy in Japanese~     type 2 diabetic patients.~   "
205741|NCT00868504|"~     Previous studies have indicated that tumors are warmer than the surrounding tissues. We want~     to ascertain that this is true for tumors in the GI tract. If so, a thermal camera in an~     endoscope may aid the diagnosis of tumors. The experiment entails inserting a cannula~     sheathed thermocouple into the work canal of an endoscope or a colonoscope. The examining~     physician will bring the distal end to touch the tumors he finds and their adjacent tissues,~     noting their respective temperatures. This experiment must be conducted before embarking on~     the complicated and costly project of producing a tiny thermal camera which will be able to~     navigate the GI tract.~   "
205742|NCT00868491|"~     The purpose of this study is to determine the efficacy and toxicity of~     docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant~     chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell~     carcinoma of the head and neck.~   "
205743|NCT00868478|"~     The purpose of this study is to determine whether Milatuzumab is effective in patients with~     refractory chronic lymphocytic leukemia, and also to find out in which range of doses is a~     response seen.~   "
205744|NCT00868465|"~     Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the~     first line treatment policy in Tanzania. AL is an efficacious drug that also has the capacity~     to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the~     development of parasite resistance against AL and there have been very few clinical trials~     that compared different ACT regimens. A recent clinical trial shows that the combination of~     dihydroartemisinin-piperaquine (DP) may be more efficacious than AL and may have a more~     pronounced beneficial effect on post-treatment malaria transmission. Screening for molecular~     markers that are related to parasite susceptibility to ACT drugs and to post-ACT treatment~     malaria transmission can assist in preventing the development and spread of ACT resistance.~      In the current study, the investigators compared AL and DP for the treatment of uncomplicated~     malaria. The investigators endpoints are~        -  clinical efficacy~        -  post-treatment gametocytaemia by molecular techniques~        -  post-treatment malaria transmission.~   "
205745|NCT00868452|"~     This clinical study is designed to test the hypothesis that lurasidone is effective,~     tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of~     patients with bipolar I depression.~   "
205746|NCT00868439|"~     The purpose of this study was to assess the effects of patiromer on serum potassium~     participants with heart failure. This study also assessed the safety and tolerability of~     patiromer in participants with heart failure.~   "
205747|NCT00868426|"~     The aim of this pilot study is to assess the methodology, practical arrangements and~     pulmonary absorption with charcoal blockage for the future bioequivalence studies. In~     addition, PK of budesonide and formoterol after administration from 2 different batches of~     Symbicort TH is compared with each other.~   "
205748|NCT00868413|"~     This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with~     either FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia.~   "
205749|NCT00868400|"~     The aim of this study is to provide conclusive clinical evidence as to whether or not the~     preoperative administration of oral carbohydrate-rich solutions is effective on the outcomes~     of patients undergoing colorectal surgery.~   "
205750|NCT00868387|"~     The burden of overweight and obesity has dramatically increased during the last decades. High~     carbohydrate intake, particularly refined carbohydrates, probably increase the risk of~     obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted~     low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk~     markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy~     of weight loss programs depends on care and control. The investigators aim to investigate~     whether or not a carbohydrate-restricted telemedically guided weight loss program results in~     a more pronounced weight loss and influences metabolic risk markers more beneficial than a~     fat-restricted diet.~   "
205751|NCT00868374|"~     The primary objective is to test the hypothesis that quetiapine XR (Extended Release)~     monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or~     placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms~     in patients with MDD and comorbid GAD. The secondary objectives are to test the hypotheses~     that quetiapine XR is superior to placebo in the reduction of anxiety symptoms in patients~     with major depressive disorder and comorbid generalized anxiety disorder, the improvement of~     the quality of sleep in patients with major depressive disorder and comorbid generalized~     anxiety disorder and the improvement of the quality of life in patients with major depressive~     disorder and comorbid generalized anxiety disorder.~   "
205752|NCT00868361|"~     The purpose of this study is to characterize the chemical breakdown and excretion of~     talampanel and its break down products in plasma, feces, and urine of healthy human~     volunteers.~   "
205753|NCT00868348|"~     The purpose of this study is to determine wether ketorolac is effective in the treatment of~     postoperative pain after total knee arthroplasty~   "
205754|NCT00868335|"~     The purpose of this study is to find out if use of a cervical disc prosthesis in the~     treatment of a cervical disc herniation preserves or restores normal mobility and movement in~     the cervical spine.~   "
205755|NCT00868309|"~     This phase II study was a prospective, randomized, open-label, multi-center study in the~     United States, involving patients from 18 to 70 years of age, comparing Anavip (Antivenin~     Crotalinae [pit viper] equine immune F(ab)2; Instituto Bioclon, Mexico City, Mexico) against~     CroFab (Protherics Inc., Nashville, Tennessee), the only currently approved product for~     treatment of Crotalinae (pit viper) envenomation in the US.~      The study was designed to evaluate the hypothesis that lasting correction of snakebite~     induced thrombocytopenia and hypofibrinogenemia are possible following correction with F(ab)2~     antivenom, by analyzing in detail the relationships among platelet count, fibrinogen, venom~     levels, and antivenom levels in subjects presenting with thrombocytopenia following crotaline~     viper envenomation. In the study we expected to see a fall in platelet count following Fab~     treatment, commensurate with that reported in the past. We hypothesized that following F(ab)2~     treatment there would be a slower drop in post-treatment platelet counts, with a relatively~     higher platelet count at any given point in the follow-up period. We further hypothesized~     that an initial rise and later fall in platelet count would correspond with rise and fall in~     antivenom levels, and would be mirrored by concurrent drop and rise in levels of unbound~     circulating venom.~   "
205757|NCT00868283|"~     The study investigated the clinical efficacy and safety of a 10-day course of therapy with~     daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in~     patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2~     parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug~     will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic~     acid will be given orally, once daily throughout the study duration of 90 days as basic~     treatment. The clinical observation period for each patient will be 3 months and will include~     six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.~   "
205758|NCT00868270|"~     The prevalence of kidney scarring after UTI is approximately 5-57%. UTIs are caused mainly by~     bacteria that cause local and systemic immunological reaction that are accompanied by~     cytokines. These cytokines are a main factor in the inflammatory process. They are produced~     by leukocytes, macrophages, fibroblasts, endothelial cells and epithelial cells in the kidney~     tissue. Interleukin 6 and 8 (IL-6 IL-8) were found in high levels in the urine of children~     and adults who suffer from UTIs. Other studies on animals have found a relationship between~     inflammatory reaction and scarring in the kidney. We hypothesize that we will find a similar~     relationship between the level of IL-6, IL-8 in the urine during acute pyelonephritis in~     children and the probability of kidney scarring.~   "
205759|NCT00868257|"~     This study will compare methods of determining whether HIV-infected children take their~     medications.~   "
205760|NCT00868244|"~     The purpose of this study is to determine if the facial pattern is related to the degree of~     bruxism because the muscles of mastication are the factors of force to the wear of the teeth.~   "
205761|NCT00868231|"~     The main purpose of this study is to evaluate the efficacy, safety and tolerability of~     multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.~   "
205762|NCT00868218|"~     The safety and tolerability of the pandemic A/H5N1 virosomal vaccine formulated with or~     without the 3rd generation ISCOM™ adjuvant for parenteral administration will be investigated~     locally and systemically and by using haematological, biochemical and immunological screening~     tests. The immunogenicity of the H5N1 vaccine will be assessed through the induction of local~     and systemic antibody and cellular immune responses. In a pandemic situation, an important~     aspect is the rapidity of the immune response to the H5N1 vaccine so the detailed kinetics of~     the immune response will be investigated. The capacity of the vaccine to elicit long lasting~     immunity and cross reactive immunity to H5 viruses will also be evaluated. Furthermore, the~     quality of the immune response induced by the vaccine will be studied. The vaccine will be~     administered as twice the normal human dose (30μg HA) with and without adjuvant, and in a~     dose sparing manor of half (7.5μg HA) and one tenth (1.5μg HA) of the normal human dose with~     adjuvant. Sixty subjects will receive two doses of virosomal H5N1 influenza vaccine~     (separated by 21 ± 4 days) by intramuscular injection into the deltoid muscle. Escalating~     doses will be separated by a period of one week. Four groups each containing 15 subjects will~     receive two doses of the pandemic virosomal A/H5N1 influenza vaccine containing:~      Group 1 30µg HA IM, Group 2 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 3~     7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 4 30µg HA adjuvanted with 50µg~     3rd generation ISCOM™ IM.~   "
205763|NCT00868205|"~     Food and beverage intake that leads to a decrease in the level of in vivo markers of~     oxidative stress indicates that such foods and beverages act as antioxidants (AOX) in humans.~     Coffee drinking at a high level (> 900 ml/day) for a short period of time (1 week) has been~     shown to reduce DNA oxidative damage—as indicated by a decrease in the level of percent tail~     DNA (%T)— in study populations comprised mainly of young adults aged < 30 years. It is not~     clear whether such findings remain present over a longer period of time, and to extend such~     findings across a population that is more representative of European adults who consume~     common daily intakes of coffee, which is a low-to-moderate daily intake level (< 750 ml/day).~     As such, the investigators propose to determine the effect of drinking 3 and 5 cups of coffee~     per day (equivalent to 450 and 750 ml per day, respectively) for 8-weeks on markers of in~     vivo oxidative stress relative to control in a population of healthy adults free of chronic~     diseases aged 35 to 65 years. To ensure that overall health is considered, the investigators~     will also evaluate the effect on markers of cardiovascular health, inflammation, and glycemic~     control.~   "
205764|NCT00868192|"~     The purpose of this study is to determine if the combination of bevacizumab and pemetrexed~     have an effect on recurrent ovarian and primary peritoneal carcinoma by looking at~     progression and survival at 6 months.~   "
205765|NCT00868179|"~     Currently standard of care for preventing blood clots in total knee replacement patients is~     the drug Fragmin which is a daily injection for 10 days after surgery. Patients are in~     hospital for 3 to 5 days after total knee replacement surgery and patients are taught in~     hospital to do their injections.~      The investigators would like to introduce the drug Pradax. Pradax is a Health Canada approved~     once a day, oral drug that may prevent blood clots in the patient's leg. In this study the~     patient will receive the standard of care injection drug Fragmin while in hospital but on~     discharge home the patient will take the oral drug Pradax daily (2 tablets 110mg) for 10~     days.~   "
205766|NCT00868166|"~     The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as~     add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as~     compared to placebo, assessed by the 18-month survival rate.~   "
205767|NCT00868153|"~     This is an open-label, uncontrolled, multi-centre observational study that analyses a~     follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a~     period of one year.The patients evaluated at four visits, beginning with the insertion visit~     and 3, 6 and 12 months after insertion.~   "
205813|NCT00867555|"~     The body of evidence regarding the health benefits of green tea has grown considerably during~     the last decade and includes antioxidant properties, anti- cancer, anti-obesity and~     anti-diabetes effects. There has been evidence that green tea extract favorably affect body~     weight and body fat and has positive effects on blood glucose control~      Aim of this study is to investigate the short term effect (3-day)of TEAVIGO (high in the~     catechin EGCG) on postprandial fat oxidation during different phases of the postprandial~     period in overweight subjects. Secondly, in a subset of volunteers changes in lipolysis and~     glucose metabolism will be studied in skeletal muscle and adipose tissue.~   "
205768|NCT00868140|"~     Our hypothesis is that hyperinsulinemia increases the renal clearance of D-chiro-inositol~     (DCI) in women with polycystic ovary syndrome (PCOS) and that this leads to a reduction in~     circulating insulin-stimulated D-chiro-inositol-containing inositol phosphoglycan (DCI-IPG)~     release. To assess the effects of a chronic reduction in circulating insulin on DCI~     metabolism, we propose to reduce circulating insulin in obese women with PCOS by improving~     insulin sensitivity with the drug pioglitazone. Pioglitazone is a thiazolidinedione that~     improves peripheral insulin sensitivity, presumably by activation of the peroxisome~     proliferator-activated receptor gamma (PPARγ) receptor. Administration of pioglitazone to~     women with PCOS has been shown to improve insulin sensitivity, reduce insulin secretion, and~     decrease both fasting and post-prandial serum insulin concentrations.~   "
205769|NCT00868127|"~     The purpose of this study is to determine the long-term safety of lapaquistat acetate, once~     daily (QD), as monotherapy or in combination with other lipid-lowering agents in Subjects~     with Hypercholesterolemia.~   "
205770|NCT00868114|"~     This research study uses radiation or a gene therapy agent, TNFerade in addition to a~     dendritic cell vaccine in patients with locally advanced or low volume metastatic pancreatic~     cancer. The use of TNFerade or radiation serves to generate cell death stimulating the immune~     response. The dendritic cell vaccine may direct a distant and lasting effective anti-tumor~     immune response to achieve a local and systemic clinical benefit.~   "
205771|NCT00868101|"~     The study research is to analyse brief episodes of limb ischemia applied to children the day~     before open heart surgery as protection from myocardial injury induced by extracorporeal~     circulation.~   "
205772|NCT00868088|"~     Our study is designed to evaluate the efficacy of photodynamic therapy (PDT) for treatment of~     actinic cheilitis (AC) and as an adjunct to Mohs surgery for squamous cell carcinoma (SCC) on~     the lips. This study will utilize an FDA approved PDT modality (DUSA, Inc., Wilmington, MA~     01887) using topical 5-amino-levulinic acid (ALA) for photosensitization followed by exposure~     to a Blu-U light source emitting 405-420nm wavelength light.~   "
205773|NCT00868075|"~     The aim of our study is to ascertain whether chest physiotherapy + pulmonary rehabilitation~     is more efficacious than chest physiotherapy alone. The outcomes that will be used to assess~     effectiveness are relevant in terms of the direct benefit on the patient's health related~     quality of life.~      PLANNED STUDY: This randomized study will compare 8 weeks chest physiotherapy with 8 weeks~     chest physiotherapy plus pulmonary rehabilitation.~   "
205774|NCT00868062|"~     In situations such as dehydration, illness and surgery, fluid 'drips' are given to patients~     to keep them hydrated. Different fluids stay in the circulation for different lengths of~     time. For example, some types of fluid remain in the circulation for a short time which means~     patients would need to be given more fluid to achieve the desired effects. Giving a lot of~     fluid to sick patients can in itself cause problems, for example, it can affect the way the~     bowels work and delay the patient's recovery from illness. In these situations the~     investigators use specialized fluids called colloids, that are designed to stay in the~     circulation for longer. This means a smaller amount of fluid needs to be used and less~     problems are likely to occur. There are two different types of colloids that are commonly~     used, but the investigators do not know which of them is better. The purpose of this study is~     to investigate which of the two different colloids (one is called Gelofusin and the other is~     called Voluven) works better in patients who undergo surgery. Knowing which of the two fluids~     works best in patients will help us improve the care of surgical patients. The investigators~     hypothesis is that the fluid that has the larger size of molecules as part of the solution~     will work better during surgery.~   "
205775|NCT00868049|"~     The aim is to identify differences in the stomatognathic system, mastication and deglutition~     functions between obese and normal weight subjects.~   "
205776|NCT00868036|"~     Hives affects 10-25% of the population worldwide at some time during their lifetime. Hives~     are itchy transient swellings of the skin lasting 4-36 hours. Chronic urticaria is defined as~     hives that have been ongoing for six weeks or more.~      Patch testing is performed to diagnose allergic contact dermatitis, and if contact allergens~     are found via patch testing, patients can often be cured of their dermatitis. However, patch~     testing is currently not routinely performed in the evaluation of patients with chronic~     idiopathic urticaria.~      Our hypothesis is to see if contact allergens can be identified with patch testing in~     patients with chronic urticaria, and, if any allergens are identified, to see if avoiding~     these contact allergens will make the chronic urticaria go away.~   "
205777|NCT00868023|"~     Multinational, multicentre, randomised, double blind, double dummy, placebo and active~     controlled, 5-way cross over~   "
205778|NCT00868010|"~     This is a 12-week, randomized, placebo controlled study to determine if donepezil (Aricept)~     treatment during rehabilitation after stroke improves functional recovery.~   "
205779|NCT00867997|"~     The overall objective of this three-armed randomized clinical trial (RCT) is to determine the~     comparative efficacy of three treatments for hypersensitive noncarious cervical lesions~     (NCLs): chemoactive dentifrice use, dentin bonding agent (DBA) with sealing, and flowable~     resin-based composite restoration. The primary outcomes of this study are the~     reduction/elimination of hypersensitivity and the effect of treatment as measured by~     patient-reported outcomes. Secondary outcomes, as determined by laboratory evaluation of~     intraoral replicas of pre- and posttreatment NCL surfaces, are tubule occlusion, retention of~     resin coating, retention of restoration, and change in lesion size. Outcomes will be~     ascertained via the following specific aims:~      Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by both~     measurement and by patient-reported outcomes among three treatment groups.~      Specific Aim 2: To recruit subjects with teeth with hypersensitive NCLs, measure baseline~     sensitivity and subject quality of life, administer one of three different treatments to each~     of three randomized groups of subjects, and determine immediate posttreatment~     hypersensitivity.~      Specific Aim 3: To compare the degree of tubule occlusion before and after the three~     treatments and to associate these findings with posttreatment hypersensitivity,~     patient-reported outcomes, and restoration retention.~      Treatment of NCLs remains controversial. Few studies have compared treatment methods or their~     financial implications. This RCT will determine the reduction of NCL hypersensitivity and~     patient-reported outcomes over a 6-month period for each of three different treatments. This~     will be the first practice-based research network RCT to combine objective clinical~     assessment of NCL treatment patient-reported outcomes with laboratory examination of dentin~     tubule occlusion and lesion size.~   "
205780|NCT00867984|"~     Approximately 40% of resynchronization therapy recipients do not appear to clearly benefit.~     These patients are termed 'non-responders'. This study will assess whether a heart ultrasound~     (echo) technique called 'torsion imaging' can be used to increase the likelihood of benefit~     from resynchronization therapy.~   "
205781|NCT00867971|"~     Recombinant growth hormone is a common therapy in the pediatric population. A number of~     associated side effects have been described. Several years ago, a case report was published~     concerning a child that was treated with RGH and developed acute glaucoma. To date no study~     has evaluated the connection.~   "
205782|NCT00867958|"~     Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication:~     Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during~     colonic or colorectal resection.~      Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18~     years of age or older who are scheduled for non emergency laparoscopic or open colonic or~     colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the~     discretion of the surgeon.~      No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment:~     During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up~     evaluation will be performed daily while hospitalized, during a post-op clinic visit at~     approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3~     months.~      Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence~     of adverse events related to the use of the CAR™ 27 device.~   "
205783|NCT00867945|"~     The investigators hypothesize that pregnancy-induced analgesia might be the result of~     enhanced descending noxious inhibitory activity.~   "
205784|NCT00867932|"~     The purpose of this study was to determine appropriate dose regimens of eculizumab in~     pediatric and/or adolescent patients with paroxysmal nocturnal hemoglobinuria (PNH).~   "
205785|NCT00867919|"~     This study will design and test a cognitive behavioral therapy for depressed adolescents that~     uses family interactions to help with treatment.~   "
205786|NCT00867906|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived~     peptide desensitising vaccine, currently being developed for the treatment of cat allergy.~      This study will evaluate the safety and tolerability of multiple doses of Cat-PAD in~     controlled asthmatics treated with either inhaled salbutamol, inhaled corticosteroids or~     inhaled corticosteroids with a LABA and to explore the efficacy of Cat-PAD in these subjects~     using the Late Phase Skin Response, Early Phase Skin Response, and Conjunctival Provocation~     Test.~   "
205787|NCT00867893|"~     Some medications used to treat the restless legs syndrome (RLS) when taken for some time make~     the condition worse. This study seeks to find a method for early detection of this problem so~     that it can either be prevented or corrected.~   "
205788|NCT00867880|"~     The primary objective of this study is to evaluate the pharmacokinetic profile of a single~     dose of IVIb administered over 5-7 minutes.~   "
205789|NCT00867867|"~     Iron fortification of foods is usually considered the most cost-effective approach to prevent~     iron deficiency. However, iron is the most difficult mineral to add to foods. When added as~     water-soluble, highly bioavailable compounds such as ferrous sulfate, the soluble iron~     rapidly catalyzes fat oxidation resulting in rancid products. In addition, water-soluble iron~     compounds can cause unacceptable color reactions during storage and food preparation. Thus,~     food manufacturers are often obliged to use water-insoluble iron compounds to fortify foods~     and fortification compounds such as elemental Fe powder and ferric pyrophosphate are widely~     used to fortify cereal flours and infant cereals. However, these compounds never dissolve~     completely in the gastric juice and are usually far less well absorbed than ferrous sulfate~     (Hurrell 1997). Ferrous fumarate on the other hand, although almost insoluble in water,~     readily dissolves in the gastric juice and has been shown to have an equivalent absorption to~     ferrous sulfate in healthy, Western adults (Hurrell et al. 1989, 2000). Because it is~     non-water soluble, it causes relatively few sensory problems in the fortified foods and is~     therefore an interesting food fortificant. Iron absorption from ferrous fumarate has been~     demonstrated to be significantly higher than from ferric pyrophosphate in European infants~     (Davidsson et al. 2000) and this compound is currently used to fortify blended cereal flours~     for food aid programs and commercial infant cereals in Europe. However, based on our recent~     study in Bangladeshi children, there is now concern that due to lower gastric acid output,~     young children in developing countries may not be able to absorb ferrous fumarate as well as~     Western adults (Davidsson et al. 2001a, Sarker et al. 2001, 2003). Clearly, there is a need~     to evaluate the efficacy of water insoluble iron compounds to prevent the development of iron~     deficiency/iron deficiency anemia in infants and young children living in developing~     countries. The aim of this study is to evaluate the efficacy of ferrous fumarate and ferric~     pyrophosphate, as compared to ferrous sulfate, as food fortificants in preventing development~     of anemia/IDA in Bangladeshi infants and young children (part I).~      A potential cause of low gastric acid secretion in Bangladesh and many developing countries~     is Helicobacter pylori infection. Although H. pylori-infection appeared to have no influence~     on absorption of ferrous fumarate in children, the impact of chronic H. pylori infection in~     adults could be expected to be more pronounced due to long time effects on the gastric~     mucosa, resulting in reduced gastric acid output. The other aim of the study is therefore, to~     assess of iron absorption and gastric acid output in adult women of child-bearing age with H.~     pylori infection (part II).~      Two hundred and forty non-anemic Children (Hb>105 g/L) will be randomized to three study~     groups; ferrous fumarate, ferric pyrophosphate or ferrous sulfate (n=80 per group) in wheat~     flour- and cow milk-based infant formula and will be fed for 9 months. Hemoglobin, serum~     ferritin, and transferin receptor will be analyzed at baseline and after 4.5 and 9 months of~     intervention. Prevalence of anemia and iron deficiency during and after the intervention~     among the three groups will be compared (part I). We furthermore propose a complementary~     study to determine the relative absorption of ferrous fumarate (relative to ferrous sulfate)~     in H. pylori infected and non-infected adult Bangladeshi women (15 each) of 20-40 year of age~     with IDA using stable isotope technique based on the incorporation of iron stable isotopes~     into erythrocytes 14 days after administration. Assessment of gastric acid output will also~     be performed. Iron stature and absorption, and assessment of gastric acid output will be~     compared before and after therapy in H. pylori infected women (part II). The results of this~     study are expected to have implications in the prevention and treatment of iron deficiency~     anemia in developing countries~   "
205790|NCT00867854|"~     This laboratory-based sub-study of ATN 061 and ATN 071 will examine the effect of early~     treatment followed by treatment de-intensification to atazanavir/ritonavir (ATV/r)~     monotherapy on steady-state frequencies of replication-competent CD4+ T cell Human~     Immunodeficiency Virus (HIV)-1 reservoirs or cell-associated infectivity (CAI) and persistent~     low-level viremia (LLV), and their contribution to successful long-term control of HIV-1~     replication among HIV-1 infected adolescents and young adults.~   "
205791|NCT00867841|"~     Pneumonia, or lung infection, is usually treated with antibiotics targeted against the~     organisms that the physician guesses are causing the problem. The determination of the exact~     cause of a patient's pneumonia is difficult. The problem is that the two major causes of~     community-acquired pneumonia are not easily distinguished on clinical grounds and are best~     treated by different antibiotics. The investigators hypothesize that antibiotic therapy can~     be targeted and improved by doing polymerase chain reaction (PCR) testing of nose swabs to~     identify probable implicated organisms and their antibiotic resistance patterns. This pilot~     study will be important to ensure that the laboratory testing is functional and that the~     emergency department-laboratory communication is optimal prior to doing a full-fledged~     randomized clinical trial.~   "
205792|NCT00867828|"~     The purpose of this study is to evaluate the efficacy of NKO™ softgels in reducing decline of~     global cognitive function as measured by the Neuropsychological Test Battery (NTB), in~     patients diagnosed with early stage Alzheimer's disease when compared to fish oil and a~     placebo after 24 weeks of treatment.~   "
205793|NCT00867815|"~     The primary objective of this study is to determine whether the use of PDE5 inhibitors~     (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.~   "
205794|NCT00867802|"~     The purpose of this study is to assess the effect of meditation training called~     Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among~     adult survivors of child abuse.~   "
205795|NCT00867789|"~     The purpose of this study is to determine if there is a difference between an antibiotic,~     trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses~     following incision and drainage.~   "
205796|NCT00867776|"~     The purpose of this study is to pilot-test a culturally-tailored, community-based educational~     program for African-Americans, focusing on how to use exercise and other self-management~     strategies to reduce depressive symptoms and improve health. This study will explore what~     type of additional support would encourage depressed African-Americans to exercise regularly.~     The investigators hypothesize that participants will report greater frequency of exercise and~     lower depression scores at the end of the program than they did at baseline. However, this~     study is not adequately powered to test this hypothesis - the main goal is to assess~     feasibility, acceptability and satisfaction of the pilot intervention.~   "
205797|NCT00867763|"~     Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective,~     IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the~     ovaries are being compared to mild stimulation doses. The goal of the research is to~     determine which of these if more suitable as a low cost approach for varying individual~     patients.~   "
205798|NCT00867750|"~     This study is open to patients with primary HCC who cannot be treated by potentially curative~     treatment modalities, such as surgical resection, liver transplantation or percutaneous~     ablation.~      Patients that satisfy the study eligibility criteria will be randomised in a 1: 1 ratio to~     receive either Radioembolisation with SIR-Spheres Microspheres or the standardised~     Transarterial Chemoembolisation procedure.~      Study Objectives~      This study will evaluate and compare quality of life as well as safety and efficacy of RE or~     TACE in patients with unresectable HCC. Patients will be followed for a minimum of 12 months~     or until death wherever possible in the evaluation of the primary and secondary objectives of~     this study.~   "
205814|NCT00867542|"~     oral status and early childhood caries (ecc) in israeli children with past IUGR~   "
205799|NCT00867737|"~     The objectives of this study are to measure Impulse Oscillometry (IOS) in patients with~     asthma extensively at baseline in patients with mild-to-moderate asthma, treated with~     as-needed short acting beta agonist only, to measure respiratory resistance and small airway~     dysfunction accurately and precisely at baseline, from which to measure onset of action of~     Advair MDI in comparison with that of Symbicort MDI. Initial screening will assess IOS~     resistance and small airway dysfunction and its response to short acting beta agonist (SABA).~     Patients will be selected from among those who manifest a 40% improvement in small airway~     function assessed by IOS low frequency reactance after SABA compared to baseline. After~     screening, patients will be randomized to receive either Advair or Symbicort; and will be~     assessed at randomization before and at several intervals after initial dosing, up to 4~     hours. Patients will return again 4 weeks after randomization for extended IOS (and~     spirometry) testing as done at randomization.~   "
205800|NCT00867724|"~     A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling~     through the colon in low risk subjects.~   "
205801|NCT00867711|"~     The aim of the present study is to investigate the molecular predictors of pemetrexed and~     carboplatin response in tumor samples of a series of MPM patients extracting the DNA and~     genotyping for the TSER polymorphism.~   "
205802|NCT00867698|"~     The purpose of this study is to determine whether AST-120 is safe and effective in the~     treatment of mild hepatic encephalopathy.~   "
205803|NCT00867685|"~     The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet~     form of the same drug. This study will also study the effect of food on the tablet form of~     the drug.~   "
205804|NCT00867672|"~     AML of the older patient constitutes a major unmet clinical need since the large majority~     will not be found eligible for induction chemotherapy. Reasons for this decision include host~     factors (comorbidities, reduced performance status, functional limitations due to age),~     leading to often poor tolerance of repeated chemotherapy courses and the unfavorable biology~     underlying this disease in older patients. Low dose Decitabine has shown very promising~     efficacy in high-risk MDS and is therefore a very promising approach also in older AML~     patients. Preliminary results from several centres have demonstrated excellent feasibility~     and good efficacy of this treatment. Therefore the investigators intend to investigate the~     effects of two drugs added onto low-dose Decitabine which have shown very promising~     synergistic effects in vitro and for which preliminary results indicate that the combination~     with low-dose Decitabine is very feasible.~   "
205805|NCT00867659|"~     This pilot study aims to address whether the prophylactic use of Cetrorelix Acetate after a~     long gonadotropin-releasing hormone (GnRH) agonist protocol post-hCG (human chorionic~     gonadotropin) administration can significantly reduce the incidence of OHSS in oocyte donors.~   "
205806|NCT00867646|"~     Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine~   "
205807|NCT00867633|"~     To study the association between aristolochic acid and urothelial carcinoma in Taiwan~   "
205808|NCT00867620|"~     Bladder cancer ranks the ninth in worldwide cancer incidence. Approximate 90% of bladder~     cancer is the malignancy of urothelium tissues, the urothelial cancer (UC). The mortality of~     bladder cancer is mainly due to recurrence and metastasis. Unfortunately, the currently~     available cytology or cystoscopy examination is of limited value because of low sensitivity~     of early disease. New biomarkers as well as detection technology are thus required to improve~     early diagnosis. By the aid of quantitative methylation-specific PCR (QMSP), which allows~     detecting tumor-derived DNA from tissues and body fluids, DNA methylation-based assay is thus~     developing for early detection and prognosis.~      The goal of this proposed project is to develop a panel of DNA-methylation based biomarkers~     for UC diagnosis, prognosis, and prediction of responses to therapy (especially the~     recurrence, invasion, survival, and responses to therapeutic agents). Although numerous~     studies have investigated the aberrant promoter hypermethylation in bladder cancers or UC,~     inconsistent results are observed. DNA hypermethylation determination may rely on not only~     the conditions of QMSP, but also the biopsy specimens of different race, environmental expose~     factors, and regional variation. We thus need to profile the DNA methylation pattern of UC~     patients in Taiwan to establish a panel of potential prediction biomarkers for local~     patients.~   "
205809|NCT00867607|"~     A Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of~     Three Weeks of Daily Dermal Application of MRX-6 or steroid on the Treatment of Mild to~     Moderate Allergic Contact Dermatitis of the Hand and Forearm.~      Total number of patients: up to 80.~   "
205810|NCT00867594|"~     The intent of the proposed study is to assess the potential of oral insulin to mitigate~     diabetic instability and reduce the frequency and severity of hypoglycemic episodes in~     patients with type 1 diabetes. Restoring hepatic glycogen stores is critical for the~     normalization of counter-regulation to hypoglycemia in these patients. Oral insulin can~     provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in~     favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral~     hyperinsulinemia~   "
205811|NCT00867581|"~     The purpose of this study is to observe delayed neuronal death of hippocampus after middle~     cerebral artery infarction in human beings.~   "
205812|NCT00867568|"~     The purpose of this research study is to evaluate a new investigational drug (TPI 287) for~     neuroblastoma and medulloblastoma both alone and in combination with temozolomide (a~     currently approved drug). An investigational drug is one that has not yet been approved by~     the Food and Drug Administration. This investigational drug is called TPI 287. This study~     will look at the safety and tolerability of TPI 287 both alone and in combination with~     temozolomide, and look to establish a safe dose of this agent. The study will also look at~     the tumor's response to these drugs, but this is not the primary objective of this study.~      TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in~     three different animal species. TPI 287 has been tested in humans in four clinical trials,~     and approximately 100 subjects with various types of cancers have received the drug. All of~     these subjects that have received TPI 287 have been adults. TPI 287 has not been tested in a~     pediatric population before this study.~      Temozolomide was tested in recurrent neuroblastoma and showed activity in a recently~     published study. Preclinical studies of TPI in combination with temozolomide have shown at~     minimum an additive effect. The ability of temozolomide and TPI 287 to be effective in~     combination is suggested by these two drugs showing even greater activity when used together.~   "
205817|NCT00867503|"~     The study design is a non-randomized, open label, single center Phase II trial. Eligible~     patients are women who have a confirmed diagnosis of ovary, fallopian tube cancer or primary~     peritoneal serous papillary carcinoma who have relapsed or are refractory to therapy after~     primary treatment of their disease.~      Patients will be treated with bendamustine Hydrochloride 90 mg/m2 intravenously on days 1(± 1~     day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose~     will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.~     20 patients will be enrolled in the study.~      OBJECTIVES Hypothesis/Rationale: To determine the efficacy and safety of bendamustine~     hydrochloride, in women with platinum and taxane refractory ovarian cancer.~   "
205818|NCT00867490|"~     This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ)~     in patients who do not achieve controlled blood pressure levels after treatment with another~     specified antihypertensive medication. There was an optional study extension for the first~     eligible 60 patients who wanted to participate that contains the triple therapy with~     amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.~   "
205819|NCT00867477|"~     The goal of this clinical research study is to use a new breathing test that measures the~     amount of nitric oxide (NO) you exhale. Researchers want to compare your NO levels to the~     amount of inflammation in your lungs, as measured using a positron emission tomography (PET)~     scan reading, and with respiratory symptoms questionnaire.~   "
205820|NCT00867464|"~     Background:~        -  Human papillomavirus (HPV) infection is necessary for the development of cervical~          cancer. Worldwide, infection with HPV types 16 and 18 accounts for approximately 70~          percent of cervical cancer cases. Available data suggest that prophylactic vaccination~          against HPV types 16 and 18 is nearly 100 percent effective in preventing persistent~          cervical infections and resultant disease from these types for at least 5 years~          following vaccination. This study is extension of a 2004 study in which 7,466 women in~          Costa Rica were randomized into vaccinated and control groups. The study described here~          proposes to extend follow-up of women recruited into this trial and vaccinated with the~          HPV-16/18 vaccine at the start of CVT for up to an additional 6 years, for a total of up~          to 10 years of follow-up. We expect to provide the HPV-16/18 vaccine to women in the~          control arm of the trial after the initial 4 years of follow-up are completed, and~          propose to follow them for an additional period as well. We will also enroll and follow~          a new group of approximately 3000 women who will be followed with state-of-the-art~          screening and will serve as an unvaccinated control group (UCG) during the extended~          follow-up period.~      Objectives:~        -  To evaluate the 10-year global impact of HPV-16/18 vaccination of young adult women.~        -  To evaluate determinants of the immune response to HPV and the vaccine and markers of~          long-term protection.~        -  To evaluate the natural history of HPV and cervical disease in vaccinated and~          unvaccinated populations.~      Eligibility:~        -  Participants in the original 2004 study who lived in the Guanacaste province and few~          areas of Puntarenas close to Guanacaste will be eligible for the LTFU study. Women who~          received the HPV-16/18 vaccine at the start of CVT will be invited for up to 6 years of~          additional follow-up, and women who were originally in the control arm of CVT and were~          offered the HPV-16/18 vaccine at crossover will also be invited for additional~          follow-up. Newly recruited controls (3,000) will be matched to the participants of the~          original study. Women in the original study were born between July 1978 and November~          1987, lived in Guanacaste or nearby Puntarenas province, and had no history of cervical~          cancer or hysterectomy.~      Design:~        -  At enrollment, newly recruited controls will receive extensive screening and treatment~          for cervical neoplasia.~        -  All women (vaccinated and controls) will be followed at 2-year intervals for up to 6~          years. Questionnaire data will be collected. Pelvic examinations will be performed at~          each visit. Cervical secretions and cells will be collected. Women with evidence of~          cervical abnormalities will have accelerated screening and will be referred to~          colposcopy for evaluation and treatment if needed.~        -  A subset of women will have extra clinic visits and extra blood and saliva samples~          collected to allow study of the immune response to the vaccine and to the disease~          itself.~   "
205821|NCT00867451|"~     This study will test the efficacy of a systematic, multi-modal intervention protocol designed~     to improve sleep functioning and subsequent alleviation of daytime cognitive and behavioral~     difficulties among children diagnosed with ADHD. It is hypothesized that children receiving~     behavioral and (if necessary) pharmacologic interventions targeting sleep will display~     improvement on objective and subjective sleep measures, neuropsychological tests, and~     teacher-, and parent-ratings of ADHD behaviors.~   "
205822|NCT00867438|"~     The objective of this study is to evaluate the efficacy and the tolerability of oral~     parnaparin sodium (210mg), administered in extended-release tablets identified as~     CB-01-05-MMX™.~   "
205823|NCT00867425|"~     The objective of this study is to evaluate the effectiveness of Virtual Lifestyle Management~     (VLM) as a behavior modification tool to promote weight loss, healthy eating and physical~     activity patterns, in the interest of reducing risk and adverse outcomes for individuals at~     high risk of type 2 diabetes (T2D) and cardiovascular disease (CVD) in a military population.~      Specific Aim: To evaluate the effect of VLM on cardiovascular risk status in participants at~     high risk or individuals with T2D enrolled in the pilot study. The investigators hypothesize~     that participants will show greater improvement in weight as well as glucose, blood pressure,~     lipids, and self-reported diet and physical activity than will similar patients who are not~     enrolled in VLM.~   "
205824|NCT00867412|"~     Patients with possible operable non-small cell lung cancer are randomised to conventional~     staging, or conventional staging and PET/CT. According to, patients with operable tumor will~     be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be~     compared with the two groups in order to asses the possible benefit of PET/CT.~   "
205825|NCT00867399|"~     The objectives of this study are to assess the safety, tolerability and pharmacokinetics of~     ABT-126 in elderly subjects.~   "
205826|NCT00867386|"~     This is an observational study for patients with type 1 diabetes, whom are already scheduled~     to have desensitization treatment to help increase the chance of receiving a pancreas~     transplant.The study staff will be looking at medical records in order to collect past,~     present and future information for each subject's medical condition and/or transplant. There~     are no additional study tests, procedures or devices needed for our analysis.~   "
205827|NCT00867373|"~     This pilot study is a randomized controlled trial with an embedded cross sectional study~     exploring parental perceptions of their weight status and how it affects their perceptions of~     their child's weight status. This study uses an educational intervention in which parents are~     informed of their actual weight status and how it affects their child's health. We will study~     the effect of this intervention on the parent's perceptions of and level of concern for their~     own and their child's weight status.~   "
205828|NCT00867360|"~     The purpose of this research study is to see how certain hormones cause changes in mood and~     thinking in some depressed patients and to determine the effectiveness of mifepristone in~     treating some forms of depression.~      This study is conducted in conjunction with an observational study Clinical and Biological~     Characteristics of Psychotic Depression.~   "
205855|NCT00866983|"~     The purpose of this study is to provide sildenafil therapy to patients who completed the~     A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not~     supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit~     from continued treatment with Sildenafil. It will be supplied until patient gets access to~     Sildenafil through Brazilian State Health Secretary from where patient resides.~   "
205829|NCT00867347|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount~     of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill~     tumor cells. It is not yet known whether radiation therapy is more effective than surgery in~     treating patients with bladder cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared with surgery in treating patients with bladder cancer who are receiving~     chemotherapy.~   "
205830|NCT00867334|"~     The purpose of this study is to evaluate the safety and tolerability of imatinib mesylate in~     combination with panitumumab for the treatment of stage IV colorectal cancer that has spread~     to the liver. It will also assess the whether imatinib mesylate, either alone or in~     combination with panitumumab, is effective in treating this type of cancer. In addition, the~     study will evaluate the feasibility of a predefined lab score and whether it can predict~     which patients will respond to treatment with imatinib mesylate.~   "
205831|NCT00867321|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib~     may also stop the growth of liver cancer by blocking blood flow to the tumor.~      PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given~     together with sorafenib as first-line therapy in treating patients with locally advanced or~     metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)~   "
205832|NCT00867308|"~     This is a single center open label phase II study of lenalidomide in IPSS Int-1 with~     increased blasts or hematologic needs with 5q31.1 deletions who have failed to respond to~     standard dose lenalidomide., IPSS Int-1 with increased blasts or hematologic needs without~     5q31.1 deletions, and Int-2 and high risk myelodysplastic syndrome (MDS) patients with or~     without 5q31.1 deletions, regardless of whether they have received lenalidomide previously or~     not. Patients will receive two cycles of 50 mg daily lenalidomide given on days 1-28 out of a~     42 day cycle. Within each of the two cycles of lenalidomide, patients will be given up to~     three weeks with no drug treatment to recover. Patients who fail to respond after two cycles~     of treatment may receive two additional cycles if stable. Patients who develop clinical~     response may continue to receive drug until disease progression.~   "
205833|NCT00867295|"~     This randomized trial is determining the role of antibiotic prophylaxis in the prevention of~     the infectious complications in patients carrying out totally implantable venous access~     device.~   "
205834|NCT00867282|"~     The purpose of this study is to investigate the time course of PF-00241939 concentrations in~     the blood following dosing by oral inhalation using dry powder inhalers.~   "
205835|NCT00867269|"~     Background:~        -  Idiopathic CD4+ lymphocytopenia (ICL) is a condition in which there is a decreased level~          of CD4+ lymphocytes (a type of white blood cell), which can lead to opportunistic~          infections or autoimmune disorders and diseases.~      Objectives:~        -  To characterize the natural history with regard to CD4+ T cell count and onset of~          infection, malignancy, and autoimmunity.~        -  To describe the immunological status of patients affected by ICL while providing the~          best possible standard therapy to eradicate opportunistic infections.~        -  To establish the timeline of CD4 lymphocytopenia, with particular focus on defining~          subgroups of patients according to the decline, stabilization, or rise of CD4+ T cell~          counts over time.~        -  To characterize the opportunistic infections that occur in ICL patients at microbiologic~          and molecular levels.~        -  To characterize the immunophenotype and possible genetic immunodeficiency causes of ICL.~        -  To determine whether measurable immunologic parameters correlate with the development of~          opportunistic infections or other comorbidities such as lymphoma in patients with ICL.~        -  To determine whether there is any association between ICL and autoimmunity.~        -  To determine CD4+ T cell turnover, survival, functionality, and cytokine responsiveness~          in ICL patients.~      Eligibility:~        -  Patients 2 years of age and older with an absolute CD4 count less than 300 in children 6~          years or older and adults or less than 20% of T cells in children younger than 6 on two~          occasions at least 6 weeks apart.~        -  Patients with negative results of HIV testing by ELISA, Western Blot, and viral load.~        -  Patients must not have underlying immunodeficiency conditions, be receiving cytotoxic~          chemotherapy (anti-cancer drugs that kill cells), or have cancer.~      Design:~        -  At the initial visit to the National Institutes of Health, the following evaluations~          will be conducted:~        -  Personal and family medical histories.~        -  Physical examination, including rheumatology evaluation and other consultations as~          medically indicated (e.g., dermatology, pulmonology, ophthalmology, imaging studies).~        -  Blood samples for analysis of red and white blood cell counts, liver function, immune~          hormones, and antibody and autoantibody levels, white blood cell growth and function,~          and DNA.~        -  Urinalysis and urine pregnancy testing for female patients of childbearing age.~        -  Evaluation and treatment of active infections as medically indicated, including~          biopsies, buccal swabs, pulmonary function tests, and imaging studies.~        -  Follow-up visits will take place approximately every 12 months or more frequently if~          indicated, and will continue for a minimum of 4 years and a maximum of 10 years.~        -  Evaluations at follow-up will include blood samples (i.e., CBC with differential,~          biochemical profile, HIV testing, etc.) and urinalysis and rheumatology consults.~   "
205836|NCT00867243|"~     The purpose of the study is to look at cells of the immune system to see if the cells are~     different among people with different risk factors that have received a liver transplant. We~     will enroll 50 patients receiving liver transplant and their donors. Both donor and recipient~     must participate in the order for the recipient to participate in the study. We will take~     blood samples from these patients and their donors.~   "
205837|NCT00867230|"~     Primary Objective:~      Determining the maximum tolerated dose (MTD) and pharmacokinetics (PK) of FTS (S-Trans,~     Trans-Farnesylthiosalicylic Acid) after daily oral administration on Days 1 through 21 of a~     28-Day cycle to patients with advanced hematologic malignancies that have progressed~     following effective therapy or for which no effective therapy exists.~   "
205838|NCT00867217|"~     The primary purpose is to determine if high dose vitamin D3 reduces the incidence of~     musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with~     early stage breast cancer and low serum vitamin D levels.~   "
205839|NCT00867204|"~     This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study~     hypothesis is to compare the performance of the Fusion ERCP short-wire system to the~     traditional Long-wire system.~   "
205840|NCT00867191|"~     The purpose of this study was to demonstrate the efficacy (% of change from baseline) of~     desloratadine to improve the nasal total symptom score of SAR to cypress pollen.~   "
205856|NCT00866970|"~     The purpose of this study is to asses the safety and efficacy of ALD518 in patients with~     Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).~   "
205857|NCT00866957|"~     The purpose of the study is to compare levels of HIF-1 α (Hypoxia Inducing Factor 1-alpha) in~     patients who have been treated with various types of liver cancer treatments.~   "
207411|NCT00846287|"~     The purpose of this study is to determine efficacy of MR imaging with hyperpolarized helium-3~     gas in COPD patients both before and after treatment.~   "
205841|NCT00867178|"~     This pilot clinical trial studies the side effects and the best way to give vorinostat with~     isotretinoin and combination chemotherapy and to see how well they work in treating younger~     patients with embryonal tumors of the central nervous system. Vorinostat may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as isotretinoin, vincristine sulfate, cisplatin, cyclophosphamide, and~     etoposide phosphate, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     vorinostat with isotretinoin and combination chemotherapy may be an effective treatment for~     embryonal tumors of the central nervous system. A peripheral blood stem cell transplant may~     be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow~     more chemotherapy to be given so that more tumor cells are killed.~   "
205842|NCT00867165|"~     The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to~     placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12~     weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The~     study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B~     (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The~     safety of ezetimibe in this subject population will also be evaluated.~   "
205843|NCT00867152|"~     A Phase I, open label, randomized, three period, one-way, two cohort, adaptive crossover~     study to evaluate the effect of darunavir/ritonavir plus etravirine and lopinavir/ritonavir~     plus etravirine on GSK1349572 pharmacokinetics in healthy adult subjects~   "
205844|NCT00867139|"~     The purpose of this study is to assess the safety and tolerability of triple combination~     antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and~     to gain data on the effectiveness of TCAD~   "
205845|NCT00867126|"~     RATIONALE: Pioglitazone may slow the growth of tumor cells and may be an effective treatment~     for pancreatic cancer.~      PURPOSE: This phase I trial is studying how well pioglitazone works as second-line therapy in~     treating patients with metastatic pancreatic cancer that progressed after treatment with~     gemcitabine.~   "
205846|NCT00867113|"~     This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The~     purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in~     patients at significant risk for recurrence following complete resection of primary GIST.~   "
205847|NCT00867100|"~     This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered~     as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe~     psoriasis (Part B).~   "
205848|NCT00867087|"~     The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab~     prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory~     diffuse large B-cell Non-Hodgkin's lymphoma.~   "
205849|NCT00867061|"~     For MDS patients who have not responded to or have progressed after an initial response to~     DNA methyltransferase inhibitors (DNMTI) and are not stem cell transplant candidates,~     therapeutic options are limited. Participation in clinical trials such as this one may be~     considered. The specific objectives of this trial are to find out which dose of ON 01910.Na~     can be safety given to MDS patients and then find out if this dose of drug has any beneficial~     effects on the patients' disease. ON 01910.Na is a new, experimental drug; the reason for~     doing this trial is based on the anti-cancer activity of ON 01910.Na that has been observed~     in laboratory experiments and in early clinical trials.~   "
205850|NCT00867048|"~     Objectives:~        -  To find out if the chance of developing a serious illness or of getting AIDS is less if~          patients start taking HIV medicines at a time when their cluster-of-differentiation-4~          (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at~          the level where there is good evidence for starting medicines.~        -  To learn more about how a strategy of starting HIV medicines early might affect other~          aspects of care, such as the chances of developing other illnesses or resistance to HIV~          medicines, the frequency of doctor visits, the cost of medical care, and general health~          and satisfaction.~   "
205851|NCT00867035|"~     Medical center personnel were screened organoleptically for bad breath by 2 investigators~     using Rosenberg scale 0-5, and measurement of breath sample in portable gas chromatograph.~     With a threshold score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S),~     subjects invited to enter clinical trial of the mechanical effect of daily tongue scraping~     with the adjunctive use of 0.12% chlorhexidine gluconate mouthwash or 0.1% stabilized~     chlorine dioxide mouthwash. Subjects randomly assigned in double-blind trial for one week.~     The null hypothesis is there will be no difference between the two rinses as adjuncts to~     tongue scraping.~   "
205852|NCT00867022|"~     Through complex hormonal pathways, insulin resistance can lead to the activation of the~     sympathetic nervous system, and vice versa. Schobel et al. showed that in PE patients,~     mus-cle sympathetic nerve activity (MSNA) is increased compared with normotensive pregnant~     and non-pregnant women. Studies assessing heart-rate variability and plasma noradrenalin~     concentrations also suggest increased sympathetic activity in PE. It has been hypothesized~     that sympathetic over-activity is a precursor of PE, normally compensated for by vasodilating~     mechanisms, but resulting in PE when the mechanisms fail. In addition to sympathetic~     activity, various markers of inflamma-tion are also associated with reduced insulin~     sensitivity, suggesting that chronic sub-clinical inflamma-tion could be part of the insulin~     resistance syndrome. The role of sympathetic over-activity and inflammatory markers in~     gestational diabetes has not been investigated~   "
205853|NCT00867009|"~     This study will estimate the response rate in patients with advanced or metastatic~     non-squamous Non-Small Cell Lung Cancer. Patients who don't progress after 4 to 6 cycles of~     induction treatment with pemetrexed, cisplatin and cetuximab will receive maintenance~     treatment with pemetrexed and cetuximab.~   "
205854|NCT00866996|"~     The purpose of this study was to better understand the treatment outcomes of extended-release~     methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder~     (ADHD) as evaluated by physicians and parents in a community setting.~   "
205858|NCT00866944|"~     The purpose of this study is to determine the effect of adecatumumab alone or following~     FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to~     compare the effect to FOLFOX alone.~   "
205859|NCT00866918|"~     This phase III trial is studying combination chemotherapy to see how well it works in~     treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more cancer cells.~   "
205860|NCT00866905|"~     We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant~     treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for~     docetaxel, since preclinical and clinical~      studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The~     combination of ixabepilone and cyclophosphamide could further improve the efficacy of~     non-anthracycline neoadjuvant therapy.~   "
205861|NCT00866892|"~     Most pediatric lacerations occur indoors and are considerably noncontaminated. Wounds that~     occur outside of the house where dirt often enters the laceration, irrigation and scrubbing~     with soap has been proven effective at decreasing post-laceration infections. To date there~     are no pediatric prospective studies addressing a less aggressive approach to face and scalp~     wound preparation in pediatrics. We argue that wiping wounds with sterile gauze soaked in~     sterile saline will not increase infection rates as compared to our current practice. In our~     emergency departments, the current standard of care for all lacerations is aggressive wound~     preparation: irrigation and scrubbing. This occurs regardless if the wound is contaminated or~     not. Research has proven that irrigation and scrubbing is unwarranted in adults with face and~     scalp lacerations. We want to perform a pilot/feasibility study comparing our two emergency~     campuses. One campus will serve as the control site, while the other will be the intervention~     site. In this pilot study, our goal is to demonstrate the feasibility of the intervention and~     provide data that a less aggressive approach to wound preparation is just as effective as our~     standard of care. We hope this project leads to further discussion about how we manage~     noncontaminated lacerations and provides a stepping-stone to a larger, appropriated powered~     study.~   "
205862|NCT00866879|"~     This study is being done to investigate the impact of changing immunosuppressive medications~     from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant.~     The primary purpose of this research study is to evaluate whether the use of mycophenolate~     mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate~     mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute~     cellular rejection in post kidney transplant patients. This study will examine whether~     switching from tacrolimus to sirolimus will better preserve long-term kidney function.~   "
205863|NCT00866866|"~     Chronic sinonasal symptoms (CSNS), such as coughing, throat clearing, nasal obstruction,~     crusting, dryness and discharge are extremely common in the general population. Although the~     physical symptoms are readily apparent, the psychosocial impact is often overlooked.~     Depression, anxiety, fear of social interaction, impaired personal relationships and~     decreased performance at work have all been associated with CSNS, often leading to multiple,~     frequent visits to the patient's primary care physician. A variety of clinical studies have~     shown that health-related quality of life (HRQoL) is significantly impaired in people with~     CSNS, with depressive symptoms being particularly common.~      CSNS may be due, in part, to tenacious nasal and paranasal secretions. It is therefore~     conceivable that a mucolytic may thin these secretions and improve mucociliary clearance,~     thereby reducing CSNS. N-acetylcysteine (NAC) is the most widely used mucolytic agent,~     particularly in patients with cystic fibrosis (CF), and has been documented as the most~     effective of the mucokinetic agents. Our group wishes to examine the use of NAC as a~     treatment for CSNS by testing the hypothesis that oral NAC reduces symptoms of CSNS compared~     to placebo.~   "
205864|NCT00866853|"~     The purpose of this study is to determine whether TMC435 influences the activity of certain~     drug-degrading proteins in the human body. The drug-degrading proteins investigated in this~     study belong to the Cytochrome P (CYP) family and are called CYP1A2, CYP2C9, CYP2D6, CYP3A4~     and CYP2C19. The activity of these drug-degrading enzymes are determined by measuring the~     blood levels of a selected set of drugs, which are taken together with TMC435, and, which are~     known to be specifically degraded by a certain member of the CYP family. This selected set of~     drugs (which are taken together and therefore called a drug cocktail) are considered as~     probes of these respective drug-degrading enzymes. By measuring the levels of these probes~     in human blood, the activity of these degrading enzymes are being revealed. In this way, we~     can determine if TMC435 influences in one way or another the activity of one or several of~     these selected drug-degrading proteins.~   "
205865|NCT00866840|"~     RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective~     treatment for melanoma.~      PURPOSE: This phase II trial is studying how well riluzole works in treating patients with~     stage III or stage IV melanoma that cannot be removed by surgery.~   "
205866|NCT00866827|"~     Controversy exists in the treatment of airway hemangiomas ranging from tracheotomy, various~     lasers, to open removal, none of which have proven to be a gold standard. Venous~     malformations of the airway are difficult to treat and also require laser therapy or open~     removal and often repeated treatments are required. Similarly airway lymphatic malformations~     can require multiple treatment modalities as well as multiple procedures and are infrequently~     eradicated when extensive. New uses for various lasers and differing treatment protocols are~     frequently developed. Review of the treatment modalities and efficacy of these methods is~     required. The goal of this research is to determine protocols for treatment of airway~     vascular malformation and to evaluate our results from treatment of these lesions.~   "
205867|NCT00866814|"~     This study will collect data on patients undergoing hernia repair using the Bard Ventrio~     Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of~     life and complications associated with the device and surgical procedure.~   "
205916|NCT00866164|"~     Intrathecal infusion pumps are increasingly used to deliver analgesics for chronic~     intractable pain. The PUMP II trial is designed to evaluate the ongoing safety and efficacy~     of the new Prometra® Programmable Pump System for intrathecal administration of morphine~     sulfate to treat chronic intractable pain.~   "
205946|NCT00865748|"~     The purpose of this study is compare the relative bioavailability of 500 mg Metformin~     Hydrochloride Extended Release Tablets by Alpharma with that of 500 mg CLUCOPHAGE® XR Tablets~     distributed by Bristol-Myers Squibb Company following a single oral dose (1 x 500 mg~     extended-release tablet) in healthy adult volunteers under fasting conditions.~   "
205868|NCT00866801|"~     The central hypothesis in the present project is that general anesthesia may alter autonomic~     control such that perioperative coronary blood flow (CBF) is significantly disturbed.~      These disturbances in coronary blood flow may contribute to the development of myocardial~     ischemia in the perioperative period. Furthermore, patients with an intrinsically altered~     autonomic sympathetic innervation, like diabetics, are even more prone to develop~     perioperative disturbances in coronary blood flow.~      Here the researchers will investigate what the direct effects are of general and locoregional~     anesthesia on the CBF. Furthermore, the researchers aim to evaluate whether diabetic subjects~     show more disturbed CBF responses to anesthesia as compared to non-diabetics.~   "
205869|NCT00866788|"~     The study is a Phase II, dose-ranging, multicenter, randomized, double-blind,~     placebo-controlled, parallel-group study of the efficacy and safety of a single~     subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent~     and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic~     despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll~     approximately 76 patients at approximately 45 study centers in the United States and Germany.~   "
205870|NCT00866775|"~     This is an 18-week, double-blind, multicenter study with gradual conversion from previous~     antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial~     epilepsy.~   "
205871|NCT00866762|"~     The aim of the present study is to evaluate the efficacy and safety of MK-0683 in the~     treatment of PV and ET. This agent has most recently been shown to be a potent inhibitor of~     the autonomous proliferation of haematopoietic cells of PV and ET patients carrying the JAK2~     V617F mutation. Accordingly, it may be anticipated that MK-0683 - by decreasing the JAK2~     allele burden - may influence clonal myeloproliferation and in vivo granulocyte, platelet and~     endothelial activation , which are considered to be major determinants of morbidity and~     mortality ( thrombosis, bleeding, extramedullary haematopoiesis , myelofibrosis ) in these~     disorders. The effects of MK-0683 at the molecular level will be studied by global/ focused~     gene expression profiling, epigenome profiling and proteomics.~   "
205872|NCT00866749|"~     Objectives:~      A. Primary objective:~      1 To assess the feasibility and the effectiveness of pediatric type therapy (augmented BFM)~     in patients age 12 through 40 with untreated precursor-B or T acute lymphoblastic leukemia~     (ALL) or lymphoblastic lymphoma (LL).~      B. Secondary objective:~        1. To evaluate the prognostic significance of minimal residual disease in bone marrow~          samples at the end of induction and at the end of consolidation in this group of~          patients.~        2. To prospectively evaluate gene hypermethylation status in this group of patients.~        3. To prospectively analyze asparaginase activity and anti-asparaginase antibody formation~          in this population of patients.~   "
205873|NCT00866736|"~     The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject~     with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of~     imatinib mesylate.~   "
205874|NCT00866723|"~     The purpose of this study is to evaluate how the participant's disease (ovarian, primary~     peritoneal serous, fallopian tube, or papillary serous endometrial cancer) responds to~     additional treatment with Avastin (bevacizumab). Participants have already received Avastin~     as part of maintenance therapy for their cancer. Maintenance therapy is a medical therapy~     that is given to people to prevent a relapse. However, cancer may return after maintenance~     therapy. This research study hopes to determine whether additional treatment with Avastin~     will be effective in treating the participant's cancer.~   "
205875|NCT00866710|"~     Background: Parkinson's disease affects up to 3% of persons over the age of 65. Lower urinary~     tract symptoms are a frequent cause of diminished quality of life in elderly persons and~     occur in up to 40% of persons with Parkinson's disease. While the exact mechanisms have not~     been determined, detrusor hyperactivity (hyperactivity of the bladder muscle) leading to~     symptoms of overactive bladder and urge incontinence is common. Behavioral and exercise-based~     therapies have relatively no side effects and have been shown to be an effective treatment~     for urge symptoms of overactive bladder in the aged population.~      Hypothesis and Specific Aims: Behavioral therapy using pelvic floor muscle exercises will~     result in a 50% decrease in the number of incontinence episodes in elderly persons (age > 50)~     with Parkinson's disease. The specific aims for this pilot study include the following:~        1. Complete a course of behavioral therapy using computer-assisted biofeedback in 20~          subjects with UI associated with PD and determine how many potential subjects need to be~          screened and enrolled to achieve this sample size.~        2. Determine the proportion of these patients who achieve a 50% or greater reduction in UI~          episodes.~        3. Examine whether responsiveness is associated with characteristics of the Parkinson's~          disease, in particular disease severity as measured by the Unified Parkinson's Disease~          Rating Scale (UPDRS).~        4. Assess the effectiveness of behavioral therapy without the use of computer-assisted~          biofeedback instruction in 10 additional subjects with PD and UI.~      Methods: The first 20 participants will be enrolled in an 8-week treatment trial of~     behavioral therapies and pelvic floor muscle exercises with computer-assisted biofeedback.~     Ten additional participants will be enrolled in the 8-week treatment trial of behavioral~     therapy, but will not have computer-assisted biofeedback. Voiding diaries as well as urinary~     symptom and quality of life questionnaires will be used to assess response.~      If persons with Parkinson's disease can complete the treatment trial and achieve a reduction~     in episodes of urinary incontinence with behavioral techniques this would lay the foundation~     for a larger, placebo-controlled trial. Assessment of responsiveness associated with severity~     of Parkinson's disease would also provide important information about the utility of this~     treatment strategy.~   "
205876|NCT00866697|"~     This is a study to determine whether therapy with pazopanib is effective and safe in women~     with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer has not~     progressed on first line chemotherapy.~   "
205877|NCT00866684|"~     Transplant recipients have a high risk to develop skin malignancies. This effect depends on~     the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on~     the other hand on the dosage (i.e., calcineurin-inhibitors). Based on the encouraging results~     of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients~     should be switched to an immunosuppressive regime including SRL, decreasing the dosage of~     calcineurin-inhibitors or converting from former immunosuppression. A conversion to a~     SRL-based therapy is effective in immunosuppression and safe regarding graft and patient~     survival.~      This study was designed to assess whether a switch to a SRL-immunosuppressive therapy~     decreases the incidence/reoccurrence of skin neoplasm.~   "
205878|NCT00866671|"~     This international, multicentre, single arm, phase IV study will assess the safety and~     efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage~     acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not~     responded to or has relapsed following treatment with at least two chemotherapy regimens. It~     is a post-authorisation safety study (PASS) conducted for the purpose of confirming the~     safety profile and the clinical benefit of nelarabine under licensed conditions of use. The~     study is observational, non-interventional, and will include approximately 40 children and~     young adults (up to 21 years of age).~   "
207412|NCT00846274|"~     To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1~     study in healthy male subjects was designed~   "
205879|NCT00866658|"~     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in~     comparison to placebo, as an add-on treatment to basal insulin with or without sulfonylurea,~     over a period of 24 weeks of treatment.~      The primary objective is to assess the effects of lixisenatide, when added to basal insulin,~     on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.~      The secondary objectives are to assess the effects of lixisenatide on body weight, 2-hour~     postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of~     patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less~     than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma~     glucose (SMPG) profiles, change in daily basal insulin and total insulin doses; to evaluate~     safety, tolerability, pharmacokinetics (PK), and anti-lixisenatide antibody development.~   "
205880|NCT00866645|"~     The primary objective of this study is to evaluate the efficacy and safety of Intramuscular~     Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared~     with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of~     study (72 hours after first dosing) from baseline.~   "
205881|NCT00866632|"~     The purpose of the study is to investigate the potential benefits of a psychological therapy,~     called cognitive behaviour therapy (CBT), for improving emotional well being after acquired~     brain injury and to demonstrate its efficacy in both under telephone (T-CBT) and face-to-face~     group (G-CBT) modes of delivery compared to an educational control group.~   "
205882|NCT00866619|"~     The purpose of this observer-blind study is to gather key efficacy, safety, and~     immunogenicity information on GSK's candidate malaria vaccine in infants and children.~   "
205883|NCT00866606|"~     This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in~     Chinese hemophilia B subjects.~   "
205884|NCT00866593|"~     The primary objective of this study is to evaluate the efficacy and safety of Generic~     Escitalopram in the treatment of Chinese patients with depression compared with Innovator~     Escitalopram(Lexapro®) by evaluating the change of HAMD-17 total score from the baseline to~     week 8.~   "
205885|NCT00866580|"~     This observer-blind study is designed to evaluate the immune response and safety of pandemic~     influenza vaccine in the elderly population.~   "
205886|NCT00866567|"~     The purpose of the study is to characterize innate immune function of premature infants, and~     identify defects that may be responsible for the development of bacterial sepsis.~   "
205887|NCT00866554|"~     The purpose of this study is to determine if a combination of neoadjuvant dutasteride and~     bicalutamide has the same efficacy and less toxicity than standard treatment with an LHRH~     agonist and bicalutamide for prostate cytoreduction prior to permanent implant brachytherapy.~   "
205888|NCT00866541|"~     Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance.~     In patients with increased respiratory resistance the role of FPPS in comparison with the~     pressure support assist breathing mode is still unclear. In this study the investigators~     evaluate objective and subjective measured data in healthy volunteers with artificial~     increased resistance and FPPS breathing assistance.~   "
205889|NCT00866528|"~     The Phase I part of the study will identify the doses of pazopanib and paclitaxel that can be~     administered safely in combination. The Phase II part of the study will not be progressed as~     documented in Protocol Amendment 01.~   "
205890|NCT00866515|"~     This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover~     study in healthy male and female subjects. There will be two treatment periods each~     consisting of 7 days. During each treatment period subjects will receive single doses of~     ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the~     morning of Day 5.~   "
205891|NCT00866502|"~     This study is conducted to evaluate the safety and tolerability of the drug product sNN0031,~     containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the~     fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed®~     II pump. Patients with a diagnosis of Parkinson's disease will be enrolled.~   "
205892|NCT00866489|"~     The current study is designed to clarify the neuroprotective effect of remote ischemic~     precondtioning on the patients underwent neurosurgery.~   "
205893|NCT00866476|"~     The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral~     vaccine) is safe and effective in the prevention of Shigella infection.~   "
205894|NCT00866463|"~     This study to will compare the blood levels of sildenafil following administration of an~     experimental tablet vs. the conventional oral tablet.~   "
205895|NCT00866450|"~     This study will look at the inflammatory (changes usually associated with infection/injury to~     the body) and bowel permeability (bowel's ability to allow contents to enter the body)~     effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low~     fat and high in calcium) on the colon (large bowel). This study may provide information to~     prevent colorectal cancer in a high-risk population~   "
205896|NCT00866437|"~     The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex~     hormones, among women suffering from severe PreMenstrual Syndrome (PMS).~      The system includes skin testing panel for identification of hormones to which the patients~     might be sensitive. Tests are applied close to the ovulation period and the skin reaction is~     examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests~     and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic~     tool for severe PMS patients.~   "
205897|NCT00866424|"~     The purpose of this study is to determine whether the hyperbaric oxygen treatment reduces~     pain and improve the life quality in trigeminal neuralgia patients.~   "
205898|NCT00866411|"~     The purpose of this double-blind randomized control research study is to determine if CES~     given in a group setting for soldiers experiencing irritability is effective to reduce the~     symptom of irritability.~   "
205944|NCT00865774|"~     The American College of Surgeons now requires screening for alcohol use in trauma centers.~     The purpose of this research study is to provide information about the best screening and~     treatment methods. The investigators hope the findings will provide information that will~     improve healthcare by reducing problems related to risky alcohol use. The trauma team is~     conducting a comparison of two different ways of talking about alcohol use. Participants will~     be randomized into one of the two study groups.~   "
205899|NCT00866398|"~     Since the advent of coronary stents, in-stent restenosis has proven to be the major~     limitation of interventional cardiology, occurring in as many as 30% of patients.~     Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis.~     They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer,~     and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel~     wall and stops the process of neointimal hyperplasia, thereby significantly reducing the~     incidence of in-stent restenosis.~      The study Economic Evaluation of the German Drug-Eluting Stent Registry examines the~     cost-effectiveness of drug-eluting stents compared to bare-metal stents (BMS) in patients~     with coronary stenosis. The goal of the study is to examine whether the guideline-supported~     implantation of SES, despite the higher initial cost, improves the quality and economic~     outcomes of the treatment of patients with coronary stenosis. Secondarily, the study~     evaluates patient quality of life, impairment of daily activities, and re-intervention rates.~   "
205900|NCT00866385|"~     A study designed to look at how the drug AZD8566 is taken up by the body when given with or~     without food. In some subjects a comparison will be made with a very small labelled microdose~     given into a vein.~   "
205901|NCT00866359|"~     The purpose of this study is to assess whether Apremilast is safe and effective in the~     treatment of patients with Behcet Disease.~   "
205902|NCT00866346|"~     Primary Objective:~      To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes~     (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after~     allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor.~      Secondary Objectives:~        1. To evaluate the immunological response following PR1-CTL treatment~        2. To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular~          response rates within 6 months~   "
205903|NCT00866333|"~     This study will evaluate the efficacy and safety of entinostat, SNDX-275, in patients with~     relapsed or refractory Hodgkin's lymphoma.~   "
205904|NCT00866320|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with~     metastatic kidney cancer that has not responded to sunitinib or bevacizumab.~   "
205905|NCT00866307|"~     This pilot clinical trial studies the side effects of pegaspargase when given together with~     combination chemotherapy in treating patients with newly diagnosed high-risk acute~     lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop~     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Giving more than one drug (combination chemotherapy)~     together with pegaspargase may kill more cancer cells.~   "
205906|NCT00866294|"~     This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the~     efficacy of controlled-release (CR) formulation of paroxetine orally administered to patients~     with major depressive disorder (MDD) at a dose level in the range of 25 - 50 mg/day (initial~     dose level, 12.5 or 25 mg/day) once daily after evening meal for 8 weeks based on the~     decrease in HAM-D (Hamilton Depression Rating Scale) total score, to evaluate the safety~     based on adverse events, laboratory data and vital signs, and to describe the efficacy and~     safety of immediate release (IR) formulation of paroxetine.~   "
205907|NCT00866281|"~     This is a phase I/II pediatric dose-ranging study that will evaluate the safety,~     tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in~     patients <18 years of age who have relapsed or refractory acute leukemias that may benefit~     from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.~   "
205908|NCT00866268|"~     Principal hypothesis:~      A low suction drainage (-50 mmHg) reduce a 25% the blood loss with respect a standard closed~     drainage (-700 mmHg) following total knee arthroplasty.~   "
205909|NCT00866255|"~     Continuous measurement of intratracheal pressure in mechanically ventilated infants using a~     fibreoptic pressure transducer in the endotracheal tube (ETT). Based on the findings,~     tracheal pressure can continuously be monitored in the presence of pediatric ETTs by~     combining ETT coefficients and the flow and airway pressure continuously measured at the~     proximal end of the ETT.~   "
205910|NCT00866242|"~     The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral~     vaccine) is safe and effective in the prevention of Shigella infection.~   "
205911|NCT00866229|"~     Early statin therapy in SLE patients that have high cholesterol level and other~     atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course~     of disease. By the way, statin is used in restricted groups of rheumatologists due to~     awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients~     more so than other groups of atherosclerosis patients and reporting data of autoimmune~     diseases that occur after statin use.~   "
205912|NCT00866216|"~     The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate~     600 mg Tablets.~   "
205913|NCT00866203|"~     The study is planned to compare the outcome of aggressive NHL patients in partial remission~     after four courses of front-line therapy, randomly assigned to receive either additional four~     courses of the same regimen or a modified HDS program.~   "
205914|NCT00866190|"~     The purposes of this study are to determine: how safe it is to take SQ109 (an experimental~     tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how~     well the body accepts it; how SQ109 enters and leaves the body and blood tissues over time;~     the amounts that can be detected in the blood; and how long it stays in the body. The study~     involves 30 volunteers: 24 will receive SQ109 and 6 will receive placebo (inactive~     substance). Qualified participants will be admitted to the study unit within 28 days from the~     screening and stay as inpatient for approximately 2 weeks. During this period they will~     receive study drug and complete all scheduled procedures including multiple blood draws.~     After discharge, there is a 14 day follow up period. Total study participation is about 56~     days.~   "
205915|NCT00866177|"~     This phase II trial is studying how well MEK inhibitor AZD6244 works in treating patients~     with stage III or stage IV melanoma. MEK inhibitor AZD6244 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
205917|NCT00866151|"~     The goal of this study is to determine the association between genotypes and diet. The weight~     and weight loss data are already available from the previously completed study called: A to Z~     Study - Benefits and Risks of Alternative Weight Loss Strategies - A Clinical Trial, which~     was performed from 2003-2005 at Stanford University. In the present study, Interleukin~     Genetics will obtain DNA samples from the previously enrolled study subjects to investigate~     genetic influence of the response to macronutrient compositions of low caloric diets to~     weight loss.~   "
205918|NCT00866138|"~     This phase 2 study was designed to assess the safety and efficacy of masitinib (AB1010) in~     patients with relapsing/refractory t(4;14) Multiple Myeloma. Response and progression were~     assessed according to the Bladé revised IMWG criteria1 from lowest point.~   "
205919|NCT00866125|"~     The aim of this study is to investigate the hand function in patients with poly-and~     dermatomyositis and compare this to healthy individuals and norm values and secondly if hand~     function correlates to activity performance and health related quality of life.~      The study is a cross-sectional study. To assess hand function the investigators will measure~     grip force with Grippit and arm/hand mobility using EPM-ROM scale. The activity performance~     will be measured with Myositis Activities Profile and health related quality of life will be~     assessed with SF-36.~      The investigators' hypothesis is that hand function is reduced in comparison to the healthy~     population and that hand function affects both activity performance and health related~     quality of life.~   "
205920|NCT00866112|"~     People with mobility disabilities are at greater risk than the general population for~     incurring health problems. Many of these conditions are preventable through behavior and~     lifestyle changes such as exercise and physical activity. Recent evidence suggests that~     people with disabilities experience the same physiologic response to exercise as the general~     population. Nonetheless, nearly three-fourths of those with disabilities report being~     entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of~     issues that limit physical activity among this population, few studies have investigated~     methods for promoting physical activity adoption among people with disabilities, including~     wheelchair users. The purpose of this study is to test the effectiveness of a behavioral~     intervention to promote physical activity adoption over 6 months and maintenance of physical~     activity over another 6 months by community-dwelling manual wheelchair users.~   "
205921|NCT00866099|"~     The purpose of this study is to develop and test an educational intervention for dementia in~     primary care, combining timely diagnosis, psychosocial support around the period of diagnosis~     and management concordant with guidelines.~   "
205922|NCT00866086|"~     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue. Abdominal compression methods that hold the~     body and the tumor from moving during treatment may permit radiation therapy to kill more~     tumor cells. This study is looking at the comfort level of two abdominal compression methods~     in patients with lung tumors undergoing stereotactic body radiation therapy.~      PURPOSE: This phase I trial is studying the comfort level of two abdominal compression~     methods used to hold patients still while undergoing stereotactic body radiation therapy for~     lung tumors.~   "
205923|NCT00866073|"~     This study is an open-label phase II trial to investigate the efficacy and toxicity of~     low-dose decitabine (5-aza-2'-deoxycytidine) in elderly patients with acute myeloid leukemia~     (AML) not eligible for aggressive induction chemotherapy. AML patients above the age of 60~     years (no upper age limit) who have not previously received and are not eligible for,~     standard induction treatment of their disease will be eligible for this trial. Decitabine~     will be administered as a 3 hour infusion at 15 mg/m2 three times daily on three consecutive~     days (total dose 135 mg/m2). In all patients with > 20000 WBC/µl, this treatment will be~     repeated 1 week later. In patients with white blood cells exceeding 50 000/μl, decitabine~     treatment will be preceded by cytoreductive doses of hydroxyurea.~   "
205924|NCT00866060|"~     The trial will examine whether pharmacological treatment with donepezil, memantine or~     combination of memantine and donepezil is any better than a placebo (dummy) treatment in~     people with Alzheimer's disease who have reached the moderate to severe stage of illness.~     Using a double blind design, where neither the investigators nor participants know who is~     receiving which treatment, participants will be randomly assigned to one of these four~     treatment groups (donepezil and memantine, memantine only, donepezil only or placebo). In~     order to keep both the investigators and participants blind to drug allocation a double dummy~     design will be necessary. This means that each participant will receive 2 treatments − either~     an active form or placebo of each of the 2 study drugs.~      Hypotheses are:~        1. Patients with Alzheimer's disease (AD) who continue donepezil beyond the point of~          transition from moderate to severe dementia continue to show significantly less decline~          on ratings of cognitive function and activities of daily living over the following 12~          months than those discontinuing donepezil.~        2. Patients with AD who change to memantine therapy in place of donepezil at the point of~          transition from moderate to severe dementia show significantly smaller decline on~          ratings of cognitive function and activities of daily living over the following 12~          months than those who receive placebo.~        3. Patients given the combination of memantine and donepezil at the point of transition~          from moderate to severe dementia show significant additive or synergistic benefits on~          measures of activities of daily living and cognitive function after 12 months compared~          to those patients continuing on either drug as a single treatment.~   "
205925|NCT00866047|"~     This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and~     safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or~     refractory ALCL.~   "
205941|NCT00865826|"~     An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV)~     treatment in the coming year, with projected rates of requirement for ARV therapy extending~     to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the~     coming decade. In these settings, Tuberculosis (TB) is an endemic infection in the~     population, and an estimated 30-60% of adults have been infected with TB, the leading~     opportunistic infection associated with HIV infection. The purpose of this study is to~     construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in~     identification of participants with active pulmonary TB, without sacrificing specificity.~   "
205942|NCT00865813|"~     The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in~     diagnosing periocular malignancy.~   "
205926|NCT00866034|"~     Rationale:~      In daily practice fertility treatment is increasingly patient focused and innovative~     medication and standardized treatment guidelines are being developed to improve patient~     convenience.~      GnRH antagonist cotreatment to prevent premature luteinization during ovarian stimulation for~     IVF and ICSI greatly reduces the burden of treatment, partly by reducing the number of~     injections by around 21 compared with the optimal GnRH agonist 'long' protocol. However, the~     optimal GnRH antagonist protocol is still not known. There are a number of reasons to suggest~     that both the simplicity of treatment and clinical outcomes could be further improved by~     commencing GnRH antagonist treatment on the same day on which ovarian stimulation is started.~     These include more synchronized follicle development and reduced rates of premature~     luteinization. This study will investigate whether a novel early fixed start protocol~     improves outcomes in comparison to the widely employed late fixed start protocol.~      Objective:~      To demonstrate whether an early fixed start antagonist protocol improves the live birth rate~     compared with a late fixed start antagonist protocol by 5%.~      Study design:~      Prospective, multicenter, investigator sponsored, randomized controlled trial~      Study population:~        -  Normo-ovulatory women < 39 years with an indication for IVF or ICSI~        -  No more than 2 previous unsuccessful IVF/ICSI cycles~        -  BMI ≤ 32 kg/m2~      Intervention:~      Two different GnRH antagonist treatment protocols used in daily practice will be compared.~     Patients will be randomized to receive one of the following two treatments:~        -  Early fixed start: start GnRH antagonist treatment with Cetrotide 0.25 mg on the same~          day as FSH, cycle day 2.~        -  Late fixed start: FSH will be administered from cycle day 2. GnRH antagonist treatment~          with Cetrotide 0.25 mg will commence on cycle day 6.~      Main study parameters/endpoints:~      The primary endpoint is the live birth rate per started cycle. A secondary endpoint is the~     number of embryos available for transfer.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      In addition to recording clinical outcomes, endocrine studies will be carried out at the UMC~     Utrecht in a sample of 200 participants who will be subjected to blood sampling at three~     points during the treatment cycle: prior to commencing treatment on cycle day 2, cycle day 6~     and the day of hCG administration.The aim of this substudy was therefore to prospectively~     compare the effect of a cycle day 2 versus cycle day 6 fixed start GnRH antagonist protocol~     on LH, estradiol and progesterone levels in the mid and late follicular phase. In order to~     investigate whether the early fixed protocol exerts a significant extra burden on patients~     compared to the late start protocol, another group of 200 participants at the UMCU will be~     requested to complete the HADS questionnaire (Hospital Anxiety and Depression Scale).~   "
205927|NCT00866021|"~     The aim of this study is to assess the efficacy of lopinavir/r in monotherapy and~     peg-interferon plus ribavirin for the control of both HIV and HCV infection respectively~     after 12 months of active treatment for HCV.~   "
205928|NCT00866008|"~     Background:~      By limiting the number of embryos transferred to the uterus to only a single embryo, the risk~     of multiple gestation can be reduced. In order to improve the effectiveness of single embryo~     transfer, the ability to select the embryo with the highest potential to develop into a~     healthy child is of vital importance. While embryos rated as high quality by standardized~     morphological assessment are associated with higher implantation and pregnancy rates, it is~     still not possible to predict with certainty which embryo will implant and has the highest~     potential to develop into a healthy child. An increasing body of evidence indicates that the~     incidence of chromosomal abnormalities in embryos is extremely high and good embryo~     morphology does not necessarily exclude an abnormal chromosomal constitution. Since~     aneuploidies are considered the main cause of embryonic wastage and loss, this phenomenon may~     be primarily responsible for the relatively poor pregnancy rates reported after IVF.~      The introduction of fluorescent in-situ hybridization (FISH) techniques for preimplantation~     genetic diagnosis has enabled screening of embryos for chromosomal aneuploidies before~     transfer. Preimplantation genetic screening (PGS) would be of special interest for couples~     that are thought to have a higher risk of developing chromosomally abnormal embryos, with the~     aim of improving their chances for an ongoing pregnancy after IVF. PGS is applied clinically~     in numerous IVF laboratories throughout the world, and high rates of chromosomal~     abnormalities have been reported in IVF derived embryos. However, a recent meta-analysis has~     shown that PGS is yet to have a significant impact on IVF outcomes. This may partly be~     explained by the fact that most aneuploidies observed at this stage originate during the~     first mitotic divisions of early preimplantation development, resulting in chromosomally~     mosaic embryos. If a chromosomally mosaic embryo is biopsied, this cell may not be~     representative for the remaining embryo.~      The investigators' group recently completed the first prospectively designed, randomized~     trial, comparing embryo aneuploidy rates following two ovarian hyperstimulation regimes in a~     group of 111 IVF patients. Milder stimulation was associated with a reduction in the number~     of oocytes retrieved and embryos generated. However, the proportion of chromosomally normal~     embryos was significantly increased. These results showed for the first time a direct~     correlation between the ovarian stimulation protocol and the incidence of chromosome~     abnormalities in the embryo. The observation that mild stimulation in some patients still~     resulted in a high oocyte yield and concurring higher proportions of abnormal embryos,~     underscores the need for further development of minimal stimulation approaches.~      Primary Objective:~      To determine whether the administration of hCG during the late follicular phase, instead of~     continuing with a fixed dose FSH, results in a more homogeneous cohort of growing follicles~     and the development of only the most competent oocytes, leading to lower aneuploidy rates in~     resulting embryos.~      Study design:~      Prospectively randomized, clinical study in 110 women undergoing IVF treatment~      Intervention:~      Randomization to one of two ovarian stimulation protocols:~        1. Conventional regimen with a daily dose of 225 IU recombinant FSH and GnRH agonist long~          protocol co-treatment~        2. Mild ovarian stimulation regimen using the endogenous FSH production by starting~          treatment on day 5 of the menstrual cycle with 150 IU / d recFSH with GnRH antagonist co~          treatment starting on day 6. As soon as two follicles reach 12 mm, treatment is~          continued with 200 IU / d rec hCG.~      In both arms, oocyte pick up, insemination and embryo culture will be performed according to~     standard procedures. On day 3, all suitable embryos will be biopsied and one or two~     blastomeres removed, depending on the number of cells within the embryo.~      FISH analysis will be performed for 10 chromosomes (1, 7, 13, 15, 16, 18, 21, 22, X and Y).~     Only chromosomally normal embryos will be transferred and cryopreserved. Embryos diagnosed as~     aneuploid or mosaic will be investigated for their implantation and developmental potential,~     by transferring them to an in vitro implantation model. After an extended culture period,~     implantation behaviour will be assessed and the entire embryo is reanalysed to detect the~     proportion of chromosomally abnormal cells. The implantation behaviour will be correlated to~     the type of abnormality and the chromosome(s) involved.~      Primary outcome parameters:~      Ovarian response, as assessed by the number of oocytes obtained and the proportion of~     chromosomally abnormal embryos per patient.~      Secondary outcome parameters:~      Number of oocytes retrieved, fertilization rates and proportion of morphologically high~     quality embryos on day 3.~      Serum estradiol, LH, progesterone, androgen and hCG levels on cycle day 3 and day of hCG.~   "
205929|NCT00865995|"~     Evaluation of tracheal pepsin as a biomarker for aspiration~   "
205930|NCT00865982|"~     In this study, patients with adenocarcinoma of the stomach, gastro-esophageal junction or the~     distal esophagus who seem operable with curative intent according to oncological and surgical~     assessment are treated with 3 preoperative cycles of DCX (Docetaxel, Cisplatin, Capecitabine)~     followed by surgical resection, followed by 3 postoperative cycles of DCX.~   "
205931|NCT00865969|"~     The purpose of this study is to assess efficacy and safety of belinostat in patients with~     relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior~     systemic therapy.~   "
205932|NCT00865956|"~     Disease management (DM) programs are being increasingly utilized by health plans to~     coordinate care, improve quality of care, and control costs in chronically ill individuals.~     DM programs for specific medical conditions, such as diabetes mellitus, congestive heart~     failure, and asthma, have demonstrated improvements in health outcomes and a number of~     studies have found economic benefits to these programs as well. There are fewer data~     evaluating multi-disease DM programs, and results have been mixed. Additionally, data on such~     programs specifically targeting substance-using populations are limited, although they are~     promising. Prior utilization and hospitalization data from Johns Hopkins Hospital, Johns~     Hopkins Health Care, and Priority Partners Managed Care Organization (PPMCO) suggest that a~     substantial portion of high-utilizing, high-cost, medically complex patients have a substance~     use diagnosis.~      The investigators hypothesize that a comprehensive DM program for medically-complex substance~     users with a history of hospitalization, consisting of intensive nurse case management along~     with behavioral incentives to reinforce engagement in primary care, can decrease inpatient~     days and costs, as well as improve outcomes for substance use, depression, and physical and~     mental functioning. The investigators will compare the case management/behavioral incentives~     intervention to usual care among a group of medically-complex, substance-using, PPMCO~     enrollees. Usual care will include access to all existing Priority Partners care management~     programs, and usual The investigators believe that this research will make an important~     contribution to the development of models of chronic care that improve health and promote the~     best use of health care resources. Additionally, the investigators believe this project will~     promote the study and development of systems to improve the health of substance-using adults,~     an underserved and often marginalized group.~   "
205933|NCT00865943|"~     The purpose of this study is compare the relative bioavailability of 10 mg Citalopram~     Hydrobromide tablets by Purepac Pharmaceutical Co with that of 10 mg CELEXATM tablets~     distributed and marketed by Forest Pharmaceuticals, Inc. following a single oral dose (1 x 10~     mg tablet) in healthy adult volunteers under fasting conditions~   "
205934|NCT00865917|"~     The study compares three treatment modalities in a human model of Postural orthostatic~     tachycardia syndrome (POTS): beta-blockers, I(f)-blockers, and placebo.~   "
205935|NCT00865904|"~     The primary objective of the study was to evaluate the safety and tolerability of VX-809 in~     participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF~     transmembrane conductance regulator (CFTR) gene.~   "
205936|NCT00865891|"~     The purpose of this study is to compare the relative bioavailability of Nifedipine ER tablets~     60 mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg~     by Bayer Pharmaceuticals Corporation, Bayer HealthCare following a single oral dose (1 x 60~     mg tablet) in healthy adult volunteers under fasting conditions.~   "
205937|NCT00865878|"~     The purpose of this study is to determine and compare the safety and efficacy of broad area~     photodynamic therapy with aminolevulinic acid (ALA-PDT) versus vehicle PDT (VEH-PDT) in the~     treatment of actinic keratoses (AK) and reduction of new non-melanoma skin cancer (NMSC) of~     the scalp or both forearms in solid organ transplant recipient subjects receiving chronic~     immunosuppressive therapy.~   "
205938|NCT00865865|"~     Computer Aided Surgery in total knee arthroplasty improves knee stability and functional~     outcomes more than conventional total knee arthroplasty.~   "
205939|NCT00865852|"~     The purpose of this study is compare the relative bioavailability of 750 mg Metformin~     Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co with that of 750 mg~     GLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 750~     mg) in healthy adult volunteers under non-fasting conditions~   "
205940|NCT00865839|"~     The purpose of this study is to compare the relative bioavailability of 500 mg Metformin~     Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co. with that of 500 mg~     CLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 500~     mg extended-release tablet) in healthy adult volunteers under fasting conditions.~   "
205943|NCT00865787|"~     This study is being done to determine if the use of EGCG-Enhanced Extra Virgin Olive Oil in a~     daily diet will improve endothelial function.~   "
205945|NCT00865761|"~     The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam~     Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia &~     Upjohn Company following a single oral dose (1 x 3 mg extended-release tablet) in healthy~     adult volunteers administrated under fasting conditions.~   "
205947|NCT00865722|"~     Background: Experimental studies suggest that remote limb ischaemic postconditioning~     (RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the~     beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia~     in healthy volunteers and in patients with stable coronary artery disease.~      Aim of the study: To evaluate the feasibility, safety and efficacy of RemPostCon in the~     setting of STEMI and primary PCI (pPCI) and to investigate potential circulating mediators of~     its effects.~      Patients and methods: Patients who undergo pPCI for anterior STEMI within 6 hours since the~     onset of symptoms are randomly assigned to receive either RemPostCon + pPCI or pPCI alone in~     a single-blind fashion. All patients receive therapy according to the current international~     guidelines. Three cycles of ischemia-reperfusion are provided to the lower limb inflating a~     cuff to 200 mmHg. Each cycle consists of 5' of ischaemia, followed by 5' of reperfusion.~     RemPostCon is started at the time of angioplasty in the infarct related artery. Primary~     endpoint is the area under the curve (AUC) of creatinine kinase - MB (CK - MB). Cardiac~     magnetic resonance (CMR) is performed early before discharge and 4 months after the event, if~     there are no contraindications.~   "
205948|NCT00865709|"~     To determine if sorafenib when added to chemotherapy will slow disease progression more than~     chemotherapy alone in patients previously untreated for metastatic colorectal cancer.~   "
205949|NCT00865696|"~     The purpose of this study is to compare the relative bioavailability of 15 mg Mirtazapine~     Tablets by Purepac Pharmaceutical Co with that of 15 mg REMERON® Tablets by Organon Inc.~     following a single oral dose (1 x 15 mg) in healthy adult volunteers under fasting~     conditions.~   "
205950|NCT00865683|"~     Women with excess adiposity while pregnant are more likely to develop gestational diabetes~     and high blood pressure during pregnancy than women of healthy weights. This may occur~     because overweight and obese pregnant women are less sensitive to insulin and have more~     inflammation than pregnant women of healthy weights. This study will examine the effect of a~     nutritional supplement, docosahexaenoic acid (DHA), on improving insulin sensitivity and~     lessening inflammation in overweight and obese pregnant women.~   "
205951|NCT00865670|"~     To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.~   "
205952|NCT00865657|"~     The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam~     Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia &~     Upjohn Company following a single oral dose (1 x 3 mg extended-release tablet) in healthy~     adult volunteers administrated under non-fasting conditions.~   "
205953|NCT00865644|"~     The purpose of this study is to determine if imiquimod cream can reverse the growth of~     neurofibromas. Imiquimod is a skin cream that works by stimulating the body's immune system~     to respond to tumors. Imiquimod cream is approved for use in patients with various skin~     lesions, including actinic keratosis, superficial basal cell carcinoma, and external genital~     warts. Information from these studies, as well as previous laboratory studies, suggest that~     imiquimod cream may help shrink neurofibromas or keep them from growing.~   "
205954|NCT00865631|"~     The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin~     Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by~     Parke-Davis following a single oral dose (1 x 800 mg tablet) or (2 x 400 mg capsules) in~     healthy adult male volunteers under non-fasting conditions, and will compare the differences~     in plasma levels after dosing the test formulation with and without food.~   "
205955|NCT00865618|"~     The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg~     Tablets Under Fed Conditions.~   "
205956|NCT00865605|"~     The purpose of this study is to compare the vasoconstriction response profile and~     bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic~     lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).~   "
205957|NCT00865592|"~     The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.~   "
205958|NCT00865579|"~     Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a~     progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of~     dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a~     precursor of DA that crosses the blood brain barrier, and also to the use of selective~     inhibitors of MAO-B, the major DA metabolising enzyme in humans.~      Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and~     tolerability of safinamide in PD patients, that have already completed a previous clinical~     study with Safinamide. The physical and neurological conditions as well as other safety~     parameters will get compared from baseline to subsequent visits.~   "
205959|NCT00865566|"~     The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine~     regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex~     with men.~      NOTES:~      As of April 2013, all vaccinations in this study have been stopped.~      As of June 2017, this study has been closed.~   "
205960|NCT00865553|"~     RATIONALE: A computer-assisted stop-smoking program may help doctors counsel patients who~     smoke and may help increase the number of patients who stop smoking.~      PURPOSE: This phase II trial is studying how well a computer-assisted stop-smoking program~     works in helping doctors counsel patients who smoke cigarettes.~   "
205961|NCT00865540|"~     The main objective of this study is to compare the effect of preoperative use of~     anti-inflammatory topical prednisolone acetate 1%, nepafenac 0.1% and ketorolac tromethamine~     0.4% of, plus a placebo, in maintaining the intra-operative mydriasis in extraction.~   "
205962|NCT00865527|"~     Colon cancer is the second leading cause of cancer death in North America. These deaths are~     preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and~     standard (optical) colonoscopy are all options for colon cancer screening, but it is not~     known which is the best at preventing death from colon cancer. A large study comparing these~     three tests is desperately needed. In this pilot study, the investigators want to find out~     what percentage of patients will show up for their screening test once enrolled. This will~     provide crucial information for the successful execution of the larger study.~   "
205963|NCT00865514|"~     This project focuses on the kinetics, metabolism and human toxicology of dichloroacetate~     (DCA)and tyrosine catabolism. The hypothesis is that tyrosine metabolism will be greatest in~     subject who harbor the KRT variant for GSTz1/MAAI for which DCA exhibits a high Km.~   "
205964|NCT00865501|"~     The Renin-Angiotensin-Aldosterone-system is important in the development of cardiovascular~     organ damage caused by arterial hypertension. This study aims at evaluating the importance of~     aldosterone with regard to hypertension induced damage to the heart. In order to do this the~     investigators will perform a comparative cross-sectional study in hypertensives and~     normotensives. In addition as interventional part the hypertensives will be treated with a~     mineralocorticoid-receptor blocker (spironolactone).~   "
205965|NCT00865488|"~     The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing~     and/or reducing post-operative adhesions in patients undergoing surgery involving the~     ovaries.~   "
205966|NCT00865475|"~     The aim of this study is to measure the prevention of lipoatrophy in patients treated with~     Lopinavir/R in monotherapy versus ZDV + 3TC + ABC~   "
205967|NCT00865462|"~     The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion~     150 mg XL Tablet to that of Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in~     subjects fed a standard meal.~   "
205968|NCT00865449|"~     This is a double blind randomized controlled study to evaluate the effect of aldactone on~     peritoneal fibrosis on incident peritoneal dialysis patients. The study would include a total~     of 40 incident peritoneal dialysis patients. Peritoneal biopsy would be made at randomization~     and 6 months after the intervention to evaluate the effect of renin angiotensin blockade on~     peritoneal fibrosis.~   "
205969|NCT00865436|"~     The purpose of this study is compare the relative bioavailability of 5 mg Glyburide/500 mg~     Metformin Hydrochloride Tablets by Alpharma with that of 5 mg/500 mg CLUCOVANCE® Tablets by~     Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy~     adult volunteers administered under fasting conditions.~   "
205970|NCT00865423|"~     The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin~     Tablets by Purepac Pharmaceutical Co. with that of 800 mg NEURONTIN® Tablets by Parke-Davis~     following a single oral dose (1 x 800 mg) in healthy adult volunteers under fasting~     conditions.~   "
205971|NCT00865410|"~     The purpose of this study is to compare the rate and extent of absorption of Bupropion HCl~     extended-release tablet (test) to that of Wellbutrin SR extended-release tablet (reference)~     after a single, one-tablet (150 mg) dose in fasted subjects.~   "
205972|NCT00865397|"~     This study is conducted in Europe. The aim of this observational study is to evaluate~     glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of~     insulin therapy in Hungary.~   "
205973|NCT00865384|"~     The purpose of this study is to compare the relative bioavailability of 15 mg Mirtazapine~     Tablets by Purepac Pharmaceutical Co with that of 15 mg REMERON® Tablets by Organon Inc.~     following a single oral dose (1 x 15 mg) in healthy adult volunteers under non-fasting~     conditions.~   "
205974|NCT00865371|"~     The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion~     150 mg Extended-Release Tablet to that of Wellbutrin SR® 150 mg Tablet after a single,~     one-tablet dose in subjects fed a standard meal.~   "
205975|NCT00865358|"~     Chronic low back pain is the most common cause of pain in the United States. Common~     treatments such as medication, physical therapy, and surgery often do not provide adequate~     relief. Yoga has shown promise for improving low back pain in studies of predominantly middle~     class white individuals. We will assess the feasibility and collect preliminary data on yoga~     for chronic low back pain in predominantly minority individuals in a community health center~     setting in a low income neighborhood of Boston, Massachusetts. We hypothesize that offering~     yoga for this population is feasible and will show promising efficacy and safety data.~   "
205976|NCT00865345|"~     The purpose of this study is to assess the performance of the subcutaneous glucose sensor~     over an extended sensor life. The sensor is currently approved for 3 days of use and this~     study will examine sensor safety and accuracy when used for six days. This study will also~     test sensor safety and accuracy when inserted in an alternate body location (buttock area in~     addition to abdomen area). The study hypothesis is that the sensor performance will not~     greatly diminish when used for six days, or in an alternate insertion area.~   "
205977|NCT00865332|"~     Background:~        -  Brain imaging studies, genetic research, and investigations of stress have provided more~          information about the role of dopamine in processing reward and punishment, and in~          vulnerability to substance dependence. Researchers are interested in learning more about~          how the brain responds to rewards, including drugs of abuse, and how these responses may~          involve genetic factors or previous stressful events.~        -  Researchers intend to use the drug amphetamine to increase levels of dopamine in the~          brain and study the effects through two kinds of scanning: functional magnetic resonance~          imaging (fMRI) and positron emission tomography (PET).~      Objectives:~        -  To examine the relationship among dopamine function, brain activity, reward processing,~          genetic profile and exposure to stress in normal healthy adults.~        -  To examine the variation in these factors between normal healthy adults and individuals~          with current cocaine-dependence.~      Eligibility:~      - Individuals 18 to 45 years of age who are either current cocaine users or healthy~     volunteers with no history of substance abuse or dependence.~      Design:~        -  The study will consist of an initial evaluation session and six study visits, four of~          which will involve fMRI scans (3 hours each) and two of which will involve PET scans (8~          to 9 hours each).~        -  Cocaine-using participants will enter the inpatient clinical research ward at the~          National Institute on Drug Abuse Addiction Research Center the night before each~          scanning session and will be discharged the following day. Healthy volunteer subjects~          will not be required to stay overnight and will arrive as outpatients for the PET~          session. Participants will not be released until researchers have determined that~          participants are not experiencing significant effects of the drug.~        -  Initial session (1): Participants will complete questionnaires about past reactions to~          stressful situations, and will be trained to do thinking tasks that will be performed in~          fMRI visits. The tasks will be practiced in a mockup of an MRI machine.~        -  MRI sessions (2-5): Participants will receive either oral amphetamine or a placebo, and~          will perform thinking, short-term memory, and reward tasks during MRI scanning as~          directed by researchers.~        -  PET sessions (6-8): Participants will receive either oral amphetamine or a placebo, and~          will provide blood samples during the PET scanning sessions. Participants will have~          short breaks during the PET scanning sessions.~   "
205978|NCT00865319|"~     This is a multiple-center Phase 2 study designed to expand the patient safety and clinical~     information using 99m Tc-Ec-DG with Spect/CT imaging, to develop procedures and methods for~     evaluation of the imaging studies, to determine comparability of diagnostic information~     between SPECT and SPECT/CT imaging and to to compare the safety and efficacy of 99m Tc-EC-DG~     SPECT/CT with 18F-FDG PET/CT in imaging patients with biopsy confirmed diagnosis of Non-small~     Cell Lung Cancer.~   "
205994|NCT00865111|"~     The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion~     150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a~     single, one-tablet dose in fasted subjects.~   "
205995|NCT00865098|"~     This study is conducted in Japanese newly diagnosed locally advanced SCCHN patients in order~     to assess tolerability and feasibility of Cetuximab plus concomitant boost radiotherapy (RT)~     regimen (the study treatment) and its safety profile (i.e. AEs: adverse events). In addition,~     efficacy (i.e. anti-tumor effect) of the study treatment is also evaluated.~   "
205979|NCT00865306|"~     The aim of this study was to develop and pilot a cognitive-behavioral therapy (CBT)~     parent-child intervention for 4-7-year-old children at risk for anxiety disorders. The~     20-session intervention was first piloted openly in 9 children (between 3/10/98 and~     1/1/2001). The intervention was then tested in 65 children in a randomized controlled trial~     versus a monitoring-only wait-list control condition. Children had to either have an anxiety~     disorder, behavioral inhibition, or be the offspring of a parent with an anxiety disorder who~     had elevated symptoms of anxiety. In practice all children but one had at least one anxiety~     disorder at baseline. Children were blocked on presence or absence of parental anxiety~     disorder and randomized to the intervention or to a no-intervention wait-list control group.~     The intervention consisted of 6 parent-only sessions, 8-13 child-parent sessions, and a final~     parent session. Post-trial assessments were conducted at six months, and at one-year~     follow-up. The hypotheses were that the children assigned to the intervention group would~     show significantly better improvement (measured via Clinician Global Impression-Anxiety~     Improvement scale and absence of anxiety disorders) than children assigned to the wait-list~     condition.~   "
205980|NCT00865293|"~     The purpose of this study is to investigate posture dependent small airway obstruction in~     subjects with obesity, and to study the capacity of FOT as a measurement tool for small~     airways obstruction.~   "
205981|NCT00865280|"~     A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of~     complicated skin and skin structure infections (cSSSI).~   "
205982|NCT00865267|"~     The purpose of this study is to determine the duration of application of halobetasol~     propionate 0.05% ointment to be used in a definitive study of bioequivalence of to~     formulations of this ointment.~      Part A: To validate vasoconstrictor assay precision.~      Part B: To evaluate the dose response vasoconstriction profile of Ultravate® 0.05% ointment~     at different dose durations over a short period of time (0.17 - 4 hrs).~   "
205983|NCT00865254|"~     Nicotine dependence is prevalent in society, cigarette smoking is associated with several~     known health risks, and most dependent individuals find it very difficult to stop smoking~     cigarettes. The present study will test the efficacy of a behavioral smoking cessation~     treatment, prize-based contingency management, that has not undergone rigorous study with~     respect to smoking, it but has demonstrated efficacy in reducing use of other substances~     (e.g. cocaine). If efficacious, prize-based contingency management would add to our~     repertoire of efficacious smoking cessation treatments.~   "
205984|NCT00865241|"~     The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg~     Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co. with that of 5 mg/500 mg~     CLUCOVANCE® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5~     mg/500 mg tablet) in healthy adult volunteers under fasting conditions.~   "
205985|NCT00865228|"~     The purpose of this study is to determine the role of time of dosing on the lipid-lowering~     effects of lapaquistat acetate, once daily (QD) or twice daily (BID), in subjects with~     hypercholesterolemia.~   "
205986|NCT00865215|"~     The purpose of this study is TO compare the relative bioavailability of Propranolol~     Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg~     Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult~     volunteers under fasting conditions.~   "
205987|NCT00865202|"~     Post-operative delirium is a common and deleterious complication in elderly patients. The~     investigators have previously found lower levels of serum tryptophan in post-operative~     elderly patients who developed delirium in comparison to post-operative elderly patients who~     did not develop delirium. The investigators hypothesize that post-operative supplementation~     of L-tryptophan will reduce the duration and incidence of post-operative delirium. This study~     is a double-blinded placebo controlled trial of L-tryptophan supplementation in~     post-operative ICU patients 60 years and older. The primary outcome measure is the comparison~     of duration of post-operative delirium in subjects who receive L-tryptophan supplementation~     versus a similar appearing control.~   "
205988|NCT00865189|"~     This study will assess the efficacy and safety of two different neoadjuvant treatment~     approaches including bevacizumab in newly diagnosed participants with high risk locally~     advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A~     or Arm B).~   "
205989|NCT00865176|"~     The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg~     ER Tablets under fasting conditions.~   "
205990|NCT00865163|"~     LASER is designed to gather data about ischemic an bleeding complications for a period of 12~     months after a PCI with the aim to optimize the therapy of these patients.~   "
205991|NCT00865150|"~     Primary Hypotheses of the study include:~        -  Metabolic profiles are influenced by gestational age, chronological age, type and degree~          of nutritional support and illness~        -  Metabolic profiles differ between neonates who receive commercial formula and neonates~          who receive primarily human breast milk~        -  Neonates who develop parenteral associated cholestasis have metabolic markers that~          identify at risk patients (high serum urea nitrogen, citrulline, histidine, methionine,~          and succinyl carnitine and low thyroxine, serine and glutamate)~        -  Neonates that have hypothyroidism have abnormal metabolic profiles (low tyrosine levels)~   "
205992|NCT00865137|"~     The purpose of this study is to evaluate the effect of food on the oral bioavailability of~     tacrolimus modified release (MR4) capsules together with a standard continental breakfast.~     The objective is to assess the pharmacokinetics and relative bioavailability with and without~     food.~   "
205993|NCT00865124|"~     Aldosterone is a significant mediator of cardiovascular injury associated with heart failure~     and the cardiovascular benefits of mineralocorticoid receptor blockade are additive to those~     of angiotensin converting enzyme inhibitors or angiotensin II (ANGII) receptor blockers. This~     study will test the hypothesis that mineralocorticoid receptor (MR) antagonists exert~     beneficial cardiovascular effects, specifically by decreasing vascular injury and improving~     vascular function. A randomized, double-blind study will be conducted, in which participants~     with Type 2 Diabetes Mellitus will undergo a series of assessments to test heart, blood~     vessel, and kidney function at baseline, and after 2 and 6 months of treatment with one of~     the following drugs:~        1. spironolactone~        2. hydrochlorothiazide (HCTZ) plus potassium~        3. placebo~      In the event of insufficient funds, randomization to the placebo arm will be stopped and~     primary assessment of outcomes will occur at baseline and after 6 months of treatment.~   "
205998|NCT00865059|"~     The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin~     Tablets by Purepac Pharmaceutical Co. with that of 800 mg NEURONTIN® Tablets by Parke-Davis~     following a single oral dose (1 x 800 mg) in healthy adult volunteers under non-fasting~     conditions.~   "
205999|NCT00865046|"~     185 veterans with chronic knee pain and advanced knee osteoarthritis will be recruited to~     participate in this study designed to test the effectiveness of a special type of electrical~     acupuncture called periosteal stimulation (PST). Participants will be divided into three~     groups. They will receive PST or a control condition once a week for 10 weeks. Two-thirds of~     the participants will receive booster sessions periodically over the course of the next 6~     months. Everyone will be called monthly during the 6 month period and then will be asked to~     return for an evaluation on site at the end of this period.~   "
206000|NCT00865033|"~     The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL~     Tablets, 1000 mg under fasting conditions.~   "
206001|NCT00865020|"~     This study was specifically designed to provide additional information on the mechanism of~     action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The~     purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that~     of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood~     Pressure Monitoring setting after a one week treatment withdrawal.~   "
206002|NCT00865007|"~     The aim of this study is to evaluate the efficacy for the recovery of peripheral fat of~     lopinavir/ritonavir in monotherapy versus abacavir/lamivudine and lopinavir/ritonavir in~     subjects who developed lipoatrophy while receiving zidovudine plus lamivudine plus abacavir.~   "
206003|NCT00864994|"~     There is increasing evidence in the literature that COPD should not be considered as a~     localised pulmonary disorder but as a systemic disease involving pathology in several extra~     pulmonary tissues. Well characterized systemic features are a chronic low grade systemic~     inflammation, altered body composition and a skeletal muscle fibre type shift. There are~     indications that an absolute or relative increase of fat mass puts COPD patients at increased~     risk for cardiovascular pathology while muscle atrophy is associated with a high prevalence~     of osteoporosis and with impaired physical function. The origin of systemic inflammation is~     poorly understood. Both endogenous and exogenous risk factors contribute to systemic~     inflammation and extra-pulmonary manifestations of COPD.~      Overall objective of study 3:~      To compare the pattern and severity of the systemic inflammatory profile in relation to~     skeletal muscle weakness and cardiovascular risk profile in COPD patients with mild to~     moderate disease compared to non-susceptible smokers.~      Specific objectives:~        1. To study the relative contribution of pulmonary and extra pulmonary factors on exercise~          capacity, skeletal muscle function and health status~        2. To relate diet, physical activity and cardiovascular risk factors to body composition,~          skeletal muscle function and exercise capacity status~        3. To study the influence of the emphysema phenotype on extra pulmonary pathology in COPD~        4. To study muscle fibre type size and composition and to relate muscle oxidative phenotype~          with insulin sensitivity, inflammation (local and systemic) and molecular signatures of~          oxidative energy and protein metabolism.~      Study design:~      Cross-sectional study. Healthy smoking subjects and COPD patients will undergo extensive~     clinical, metabolic and inflammatory assessment at the university clinics in Groningen,~     Maastricht and CIRO Horn.~      Study population:~      Totally 60 subjects will be included~        -  30 healthy subjects who after 20 pack years smoking have no signs of COPD (age 40-75~          years)~        -  30 COPD patients with GOLD stage II (age 40-75 years)~   "
206004|NCT00864981|"~     The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150~     mg SR Tablets under fasting conditions.~   "
206005|NCT00864968|"~     The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2~     tablet products and determine if the 2 products were bioequivalent to each other.~   "
206006|NCT00864955|"~     The DIMUVA study aims to evaluate the correlation between cutaneous phototype and the nature~     and quantity of damage caused to cutaneous DNA after exposure to UV-A radiation.~   "
206007|NCT00864942|"~     This study is for subjects with a B-cell lymphoid malignancy (lymphoma) or chronic~     lymphocytic leukemia (CLL) that has come back after or did not get better with previous~     treatment. The purpose of this study is to find out the highest dose of lenalidomide that can~     be given together with bendamustine and rituximab. The study will also look what effects the~     combination of lenalidomide and bendamustine and the combination of lenalidomide,~     bendamustine and rituximab will have on patients and their disease.~   "
206008|NCT00864929|"~     The present study is a retrospective cohort study on patients who suffered a nosocomial~     infection in major hospitals in Vietnam. Data relating to patient demography include age,~     gender; medical history; APACHE II score; background conditions, infection details and~     antimicrobial therapy; and all-caused mortality, time of hospitalization and intensive care.~     The investigators hypothesis is that antimicrobial treatment inappropriate is highly~     dependent on incidence of antibiotic resistant pathogens, nonfermentative Gram-negative~     bacilli and ESBL-producing enterobacteriaceae spp. Variables are demographic characteristics,~     background conditions, immunosuppressive therapy, antimicrobial susceptibility and~     inappropriate treatment is explored as possible predictors of mortality.~   "
206009|NCT00864916|"~     People infected with HIV have a greater risk of developing cardiovascular disease than people~     not infected with HIV. This may be due to increased inflammation in the blood vessels. This~     study will determine whether an anti-inflammatory drug, pentoxifylline, in combination with~     antiretroviral medications, is more effective at improving blood vessel function and reducing~     inflammation than antiretroviral medications alone in people infected with HIV.~   "
206010|NCT00864903|"~     A new enzymatic assay was developed by NMD Diagnostics for rapid diagnosis of Enteroviral CNS~     infection. This study will compare this assay to RT-PCR, by testing human CSF samples taken~     from children at the ER who are undergoing a spinal tap due to suspicion of meningitis.~   "
206011|NCT00864890|"~     The purpose of this study is to evaluate and compare the relative bioavailability, and~     therefore the bioequivalence of two formulations of Citalopram after a single dose~     administration under fed conditions.~   "
206012|NCT00864877|"~     A randomised, prospective clinical investigation to compare post-operative fracture healing~     and complication rate after the fixation of ankle fractures using the Inion OTPS~     FreedomPlateTM Biodegradable Fixation System versus conventional stainless steel metal screws~     and plates.~      The objectives of the investigation are~        -  to compare post-operative fracture healing (union rates, time-to-union), and the~          complication rates (hardware failure, infection) between the two Plating Systems~          (biodegradable INION OTPS FreedomPlateTM vs. Stainless Steel 3.5 Reconstruction or DCP~          plate, or 1/3 Semitubular plates) at the clinical setting of Ankle fractures~        -  to study the safety of the clinical application of the biodegradable plating system of~          Inion OTPS FreedomPlateTM at the acute Ankle fracture setting.~   "
208038|NCT00837941|"~     The purpose of this study is to determine if analgesic efficacy can be detected with single~     dose administration in patients with chronic neuropathic pain due to painful diabetic~     neuropathy.~   "
206013|NCT00864864|"~     The purpose of this research study is to determine if sunitinib can get past the blood-brain~     barrier and into the brain tumor. Sunitinib has shown promising results in treating other~     cancers and works by blocking blood flow to tumors, which may prevent them from growing~     further. At the present time, there is no chemotherapy that can cure glioblastoma. The reason~     why chemotherapy is not fully effective is that many drugs cannot penetrate into brain~     tumors. This is due to the presence of the blood-brain barrier (BBB) which normally protects~     the brain from substances in the blood.~   "
206014|NCT00864851|"~     The purpose of this study is to compare the safety and effectiveness of various doses of~     Replagal in patients with cardiomyopathy due to Fabry disease.~   "
206015|NCT00864838|"~     The purpose of this study is to evaluate the effects of anterior chamber paracentesis,~     brimonidine and oral acetazolamide to reduce intra-ocular pressure variations after~     intravitreal bevacizumab injection.~   "
206016|NCT00864825|"~     The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo,~     as add-on to anti-psychotics in the treatment of patients with schizophrenia.~   "
206017|NCT00864812|"~     Study title~        -  A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of~          tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in~          COPD patients~      Study objectives~        -  To investigate clinical outcomes of combining tiotropium with fluticasone~          propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with~          moderate or severe COPD in Korea~      Study Design~        -  Randomized, open-label, multicenter, parallel-group, two group study~      Study assessment~        -  FEV1~        -  Inspiratory capacity (IC)~        -  History of COPD exacerbation~        -  History of hospitalization for COPD exacerbation and all causes~        -  QoL (SGRQ-C)~   "
206018|NCT00864799|"~     Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead,~     severely malformed or in cases of maternal illness. This process is usually conducted~     medically in Australia, using the synthetic prostaglandin E1 analogue misoprostol. This~     prostaglandin, although not licensed for use in pregnancy termination, is now a common~     abortifacient with a large accumulated experience both within Australia and internationally.~     Since 1996, misoprostol has been used at King Edward Memorial Hospital as the principal agent~     for second trimester pregnancy termination.~      Misoprostol may be administered vaginally, orally, sublingually or buccally in the process of~     pregnancy termination. Each route of administration has its own advantages and disadvantages.~     The most appropriate route of administration, with the shortest duration of abortion and~     lowest side-effect profile has not been determined for all circumstances.~      The combination of mifepristone and misoprostol is an established and effective method for~     second trimester pregnancy termination. Prior studies have demonstrated a significant~     reduction in the duration of abortion with misoprostol when mifepristone priming is used. In~     November 2007, the TGA (Therapeutic Goods Administration) approved an application by the~     Principal Investigator of this planned study for Authorised Prescriber status for use of the~     antiprogesterone agent mifepristone. Since January 2008 the combination of mifepristone and~     misoprostol has been used at KEMH for first and second trimester pregnancy termination of~     pregnancy, predominantly for circumstances of severe fetal abnormality.~      There is however limited data on the impact of gestation on the duration of second trimester~     termination. Almost all published studies to date have recruited women in the early second~     trimester (typically with a median of 16 weeks gestation). However, most terminations of~     pregnancy for fetal abnormality (the most frequent reason for pregnancy interruption of a~     live fetus at KEMH) occur at 18-24 weeks gestation. The investigators' experience indicates a~     significant impact of increasing gestation with prolongation of the duration of pregnancy~     termination. In this study the investigators aim to evaluate three misoprostol regimens for~     second trimester pregnancy termination following mifepristone priming with the primary~     intention to develop a protocol which results in a delivery rate within 24 hours for 95% of~     women at gestations <24 weeks.~      Secondary aims of this study will be to assess the incidence of maternal side-effects for~     each of the three regimens, the placental retention rates and the need for curettage for~     retained placental tissue. As the investigators will be using 3 different methods of~     misoprostol administration, the investigators will also review women's satisfaction with the~     three regimens for pregnancy termination.~   "
206019|NCT00864786|"~     Multiple dose safety and pharmacokinetics in healthy male subjects~   "
206020|NCT00864773|"~     The pathophysiology of central serous chorioretinopathy remains controversial. traditional~     treatment is laser photocoagulation or photodynamic therapy.Recently Bevacizumab (Avastin,~     Genetech),an antibody to vascular endothelial growth factor (VEGF),has known antipermeability~     properties and therefore may theoretically reverse the changes seen in central serous~     chorioretinopathy. The aim of this study is To investigate concentrations of growth factors~     and inflammatory cytokines and to report the effect of therapy with bevacizumab in eyes with~     central serous chorioretinopathy~   "
206021|NCT00864760|"~     The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin~     Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by~     Parke-Davis under fasting conditions.~   "
206022|NCT00864747|"~     The purpose of this study is to compare the relative bioavailability of Propranolol~     Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg~     Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult~     volunteers under non-fasting conditions.~   "
206023|NCT00864734|"~     The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg~     Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co. with that of 5 mg/500 mg~     CLUCOVANCE® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5~     mg/500 mg tablet) in healthy adult volunteers under non-fasting conditions.~   "
206024|NCT00864721|"~     The purpose of this research study is to find out what effects (good and bad) sunitinib has~     on patients and their NSCLC.~   "
206025|NCT00864708|"~     The purpose of the study is to investigate new Technology for recovery of ankle walking~     function after stroke.~   "
206026|NCT00864695|"~     Descriptive analytic survey of 1137 and 518 patients aged 16 years or more before and after~     anesthesia exposure, respectively to assess the anesthesiologist-patient relationship role on~     patient postoperative perception of the binominal anesthesia-anesthesiologist. The aim of~     this study was to assess the anesthesiologist-patient relationship role on patient~     postoperative perception of the binominal anesthesia-anesthesiologist.~      Period: may/2007 to may/2008~   "
206027|NCT00864682|"~     Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics~     have been shown to attenuate this response in some patients. This randomized, double-blind,~     placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be~     superior to lidocaine administered directly into the vein, under tourniquet control, prior to~     injection of propofol. Both groups are expected to be superior to placebo.~   "
206028|NCT00864669|"~     The purpose of this study is to compare the relative bioavailability of 500 mg Metformin~     Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co. with that of 500 mg~     CLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 500~     mg extended-release tablet) in healthy adult volunteers under non-fasting conditions.~   "
208316|NCT00834301|"~     The purpose of the study is to determine whether an ingestion of a new renal multivitamin~     supplement can have a beneficial effect on bone and mineral adn inflammation issues related~     to patients on dialysis.~   "
206029|NCT00864656|"~     The primary aim of this study is to quantify eyelid position changes in tested and opposite~     eyes in ptosis patients submitted to 1, 2 or 4 drops of 10% phenylephrine in one eye. The~     secondary objective is to correlate the eye dominance, severity and laterality of ptosis with~     eyelid position changes in these 3 groups.~   "
206030|NCT00864643|"~     The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily~     (QD), coadministered with a statin to lower lipid levels in Subjects with~     Hypercholesterolemia.~   "
206031|NCT00864630|"~     The investigators seek to determine whether brain imaging techniques can be used to help~     detect depression, assess its severity, and/or monitor or predict responses to treatment.~     Subjects with minor or major depression will be randomly assigned to a wait-list control~     group or to treatment with a new computer-based cognitive behavior therapy developed by Dr.~     James Cartriene. Brain imaging will be performed before and during treatment using both~     magnetic resonance imaging (MRI) and near-infrared spectroscopy (NIRS). The investigators~     hypothesize that brain activity, particularly in the lateral frontal areas of the brain, will~     provide biomarkers for depression, depression severity, and treatment response.~   "
206032|NCT00864617|"~     The purpose of this study is compare the relative bioavailability of Nifedipine ER tablets 60~     mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg by~     Bayer Pharmaceuticals Corporation, Bayer HealthCare following a single oral dose (1 x 60 mg~     tablet) in healthy adult volunteers under non-fasting conditions~   "
206033|NCT00864604|"~     The purpose of this study is to evaluate the relative bioavailability of two formulations of~     nabumetone tablets to establish their average bioequivalence~   "
206034|NCT00864591|"~     This study is designed to determine the diagnostic value of adenosine cardiac magnetic~     resonance (CMR) when compared with SPECT.~      The investigators hypothesized that adenosine CMR could detect ischemia and is not inferior~     to SPECT imaging. In addition stress adenosine cardiac MRI offers a one stop shop enabling~     evaluation of cardiac function, rest and stress perfusion and viability.~   "
206035|NCT00864578|"~     Elevated intraocular pressure is still the main risk factor for development and progression~     of glaucoma. Several drugs exist on the market that may decrease IOP in glaucomatous~     patients. However, some patients cannot reach the target pressure despite a multitherapy with~     a combination of drugs, and are therefore addressed to surgical treatments. Forskolin is a~     natural compound that is a receptor-independent adenyl-cyclase activator, that increases~     intracellular cAMP. It has been shown to be able to decrease IOP after topical application,~     by a mechanism that is not used by the other drugs. Aim of the present study is to see~     whether a food supplement containing forskolin (KRONEK) has any effect on the IOP of POAG~     patients that cannot reach their target pressure, and are therefore on the waiting list for~     surgical intervention.~   "
206036|NCT00864565|"~     To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test)~     and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.~   "
206037|NCT00864552|"~     To evaluate long-term safety (primarily by recording adverse events including inhibitors),~     efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or~     on demand.~      To evaluate both safety and efficacy with respect to lot variability, in particular regarding~     lot-groups formulated with or without fix between.~   "
206038|NCT00864539|"~     This study is conducted in two phases. At the first phase, the prevalence of vitamin D~     insufficiency in primary school-children in Tehran is determined during the cold seasons of~     2008. Then, the efficacy of calcium-vitamin D-fortified milk, -orange juice and supplement is~     compared in six selected primary schools.~   "
206039|NCT00864526|"~     To compare the relative bioavailability of oxycodone HCl 5 mg / ibuprofen 400 mg tablets~     (Actavis Elizabeth LLC, Lot No. PI-1565) with that of COMBONOX® tablets (Forest~     Pharmaceuticals, Inc., Lot No. 010550) in healthy adult volunteers under fasting conditions.~   "
206040|NCT00864513|"~     This study is for patients with pancreatic cancer that has grown and/or spread after having~     previously received the standard chemotherapy drug called gemcitabine.~      In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for~     use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps~     pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will~     receive pemetrexed IV once every 21 days until disease progression or unacceptable side~     effects occur.~   "
206041|NCT00864500|"~     To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05%~     lotions in asymptomatic subjects.~   "
206042|NCT00864487|"~     The purpose of this study is to examine whether co-administration of rifampin with neratinib~     has an effect on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or~     excretes) of neratinib.~   "
206043|NCT00864474|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
206044|NCT00864461|"~     The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome~     patients because the prevalence of diabetes mellitus and obesity is higher in individuals~     with Down syndrome than in the general population.~   "
206045|NCT00864448|"~     To compare the rate of absorption and oral bioavailability of a test formulation of~     Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral~     dose of the commercially available reference product Atlace® manufactured by Monarch~     Pharmaceuticals Inc. administrated to healthy subjects after a 10-hour overnight fast~   "
206046|NCT00864435|"~     To compare the rate and extent of absorption of carvedilol from a test formulation of~     Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fasting~     conditions.~   "
206047|NCT00864422|"~     The motor cortex of the brain changes following chronic pain and injury, and this is linked~     to pain-associated changes in motor behaviour. This study aimed to investigate whether~     therapeutic exercises in patients with chronic pain can induce reorganisation of the motor~     cortex and restore normal motor behaviour. The investigators hypothesised that motor training~     can induce reorganisation of the motor cortex and that these changes are related to improved~     motor behaviour.~   "
206048|NCT00864409|"~     High-volume infiltration analgesia may be effective in postoperative pain management~     following total hip arthroplasty. In this randomized, double-blind trial patients undergoing~     bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration~     in one hip and similar infiltration with saline (placebo) in the other hip.~   "
206049|NCT00864396|"~     The purpose of this study is to determine whether treatment with twice-daily Lansoprazole~     30mg (Prevacid 30mg) and behavioral modifications for reflux is superior to treatment with~     behavioral modifications for reflux alone in the treatment of laryngopharyngeal reflux (LPR).~   "
206050|NCT00864383|"~     REMoxTB is a study for the Rapid Evaluation of Moxifloxacin in the treatment of sputum smear~     positive tuberculosis. REMoxTB aims to find and evaluate new drugs and regimens that shorten~     the duration of tuberculosis therapy.~      The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two~     moxifloxacin-containing treatment combinations to determine whether substituting ethambutol~     with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in~     another combination, makes it possible to reduce the duration of treatment for TB.~   "
206051|NCT00864370|"~     Very little is known about the impact of pregnancy and the postpartum period on BPD. As a~     result, the investigators have little evidence on which to base treatment guidelines. The~     main goal of this study is to help fill this gap by finding the risk factors for BPD relapse~     during pregnancy and the postpartum period.~      The risk factors that the investigators will study include:~        1. the severity of illness in the past~        2. the type and severity of both recent and past stressors~        3. any treatments received during pregnancy and the postpartum period.~      Other goals of the study are:~        1. to see what effect, if any, illness or any medicines taken during pregnancy have on the~          baby's well-being at delivery~        2. to see how pregnancy alters the way the body clears any medicines taken for BPD~        3. to see how much of these medicines babies are exposed to during pregnancy or~          breast-feeding.~      The investigators believe that the information gathered in this study will lead to new~     treatment guidelines for BPD during pregnancy and the postpartum period that will improve~     outcomes for pregnant women with BPD and their babies.~   "
206052|NCT00864357|"~     To compare the relative bioavailability of oxycodone HCl 5 mg / ibuprofen 400 mg tablets~     (Actavis Elizabeth LLC, Lot No. PI-1565) with that of COMBONOX® tablets (Forest~     Pharmaceuticals, Inc., Lot No. 010550) in healthy adult volunteers under non-fasting~     conditions.~   "
206053|NCT00864344|"~     To compare the rate of absorption and oral bioavailability of a test formulation of~     Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent~     oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer~     Inc. administrated to healthy subjects after a 10-ghour overnight fast~   "
206054|NCT00864331|"~     Primary objectives of the study are:~      To assess the differences in survival of the two treatment options in both stage III (A and~     B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study~     B), respectively~      Secondary objectives are:~      To assess the differences in toxicity of two treatment options in both stage III (A and B)~     NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the~     differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study~     A and Study B~   "
206055|NCT00864318|"~     Not randomized, multicentric, national phase II trial estimating the efficacy of an~     intensification protocol in patients with refractory germ cell tumors with relapse and bad~     prognosis.~      Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three~     Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine~     adjustment to take into account inter-individual patients variability.~      This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable~     toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high~     dose protocol.~   "
206056|NCT00864305|"~     To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of~     NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting~     conditions, and to compare the differences in plasma levels after dosing the test formulation~     with and without food~   "
206057|NCT00864292|"~     Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24).~     The first visit is the screening and entry visit which can occur at any time after the~     subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after~     SEARCH 001 study completion.~      At each visit, patients will undergo the following~        1. Assessment of function including activity of daily living questionnaire~        2. History of medical illnesses, medication history~        3. Neurological examination: All patients will have a neurological evaluation and~          neuropsychological evaluation to characterize neurocognitive and neurological status.~          (It is possible that patients within the non-dementia group will meet criteria for~          dementia after close testing is completed).~        4. Neuropsychological assessment:~        5. Thai Depression Inventory.~        6. HIV viral load and storage of blood for proviral DNA level~      Final outcome assessment based on all available data. If possible, it is intended that these~     diagnoses will be determined through monthly VTC conference calls with UH investigators. This~     consensus conference will include the Thai investigators, the UH neurologist, the UH~     neuropsychologist and the UH principal investigators.~   "
206058|NCT00864279|"~     To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations~     after administration of single doses to normal healthy subjects under fasted conditions.~     These data were to be evaluated statistically to determine if the products meet~     bioequivalence criteria.~   "
206059|NCT00864266|"~     The primary aim of the study is to identify a predictive molecular signature for response to~     chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by~     studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs)~     by using high throughput techniques.~   "
206072|NCT00864097|"~     The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab~     added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently~     experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.~   "
206073|NCT00864084|"~     The purpose of this study is to determine whether participation in pulmonary rehabilitation~     improves balance in people with respiratory disease.~   "
206060|NCT00864253|"~     The main purpose of this research study is to compare the safety, tolerability, and anti~     tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with~     metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new~     preparation of the active drug paclitaxel. It contains the same medication as the~     prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment~     of metastatic breast cancer after failure of combination chemotherapy for metastatic disease~     or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for~     the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy~     for people who have not yet had any cancer treatment for the diagnosis of metastatic~     melanoma.~   "
206061|NCT00864240|"~     To determine the dose-response relationship for Clobex TM (clobetasol propionate) Lotion,~     0.05%. This information will be used to estimate the ED50, D1, D2 parameters for use in a~     full bioequivalence study.~   "
206062|NCT00864227|"~     A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for~     people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood~     have become a treatment option for people with these types of cancers. This study will~     evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with~     lower doses of chemotherapy, to treat people with leukemia or lymphoma.~   "
206063|NCT00864214|"~     Bioidentical compounded hormone therapy (BCHT) is considered a 'safer' option to the~     conventional hormones (HT) by its proponents. However, there is limited research data to~     support their claims. Our group at the Women's Health Clinic, in collaboration with the~     Departments of Endocrinology, Complementary Medicine and Laboratory Medicine, is interested~     in developing a line of research to test the safety and efficacy of BCHT. In the present~     study, we aim to find the dose of BCHT that is bioequivalent to conventional HT, in a~     randomized, blinded, four-arm, phase I clinical trial. We will estimate the levels of estrone~     (E1), estradiol (E2) and estriol (E3) at baseline and at steady state with two-weeks of~     administration of three commonly used doses of bioidentical compounded estrogen cream (Biest)~     and a standard dose conventional estrogen patch (Vivelle-Dot). E1, E2, and E3 values will be~     summarized using point estimates and 95% confidence intervals. Two-sample t-test will be used~     to compare each Biest group to the Vivelle-Dot group. Healthy postmenopausal women, with no~     contraindications for hormone use, who are able to fully understand and participate in the~     trial, will be enrolled. We will utilize the resources of Mayo CRU to conduct this study.~   "
206064|NCT00864201|"~     The primary objectives of this exploratory study are to evaluate the effects of bosentan on~     hemodynamics (via cardiac catheterization) during exercise in patients with Pulmonary~     Arterial Hypertension (PAH) who have abnormal hemodynamics during exercise but normal~     hemodynamics at rest. The authors hypothesize that early treatment may change the course of~     disease progression by improving hemodynamics during exercise, thus delaying disease~     progression.~   "
206065|NCT00864188|"~     The aim of this study is to test if probiotics administered to healthy female subjects in a~     dairy format have any skin health benefits.~   "
206066|NCT00864175|"~     This is a single arm, modified dose escalation, open label trial with the objectives of: (1)~     Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel~     (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab~     and docetaxel.~   "
206067|NCT00864162|"~     To compare the rate of absorption and oral bioavailability of a test formulation of~     Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral~     dose of the commercially available reference product Atlace® manufactured by Monarch~     Pharmaceuticals Inc. administrated to healthy subjects after a 10-hour overnight fast~     followed by a high-calorie, high-fat breakfast meal.~   "
206068|NCT00864149|"~     To compare the rate and extent of absorption of carvedilol from a test formulation of~     Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fed conditions.~   "
206069|NCT00864136|"~     The aim of this prospective, non-interventional post-marketing surveillance study is to~     obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual~     bleeding (Menorrhagia) under daily-life treatment conditions.~      It is planned to conduct the study in about 10 countries with a total of 1000 patients. In~     several countries, a comparator group will also be documented.~      For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12~     months will be documented by the treating physician on the case report form. Observations~     include the patient's demographic parameters (date of birth, height, weight, race and smoking~     habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline~     menstruation, result of insertion, concomitant medications and diseases as well as~     menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment~     including number of weeks until improvement and reduction of menstrual bleeding with respect~     to duration and severity, and patient's satisfaction.~   "
206070|NCT00864123|"~     Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric~     obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who~     benefit often remain symptomatic upon treatment completion. Recent clinical trials in adults~     with other anxiety disorders (acrophobia and social phobia) provided support for using a~     medication called D-Cycloserine (DCS) to enahnce the outcome of exposure-based psychotherapy.~     Given this, DCS may augment CBT in youth with OCD, an anxiety disorder that is conceptually~     similar to acrophobia. With this in mind, the investigators are conducting a randomized,~     double-blind placebo controlled pilot study of DCS to determine whether it had any short-term~     clinical benefits on CBT in youth with OCD. Forty children and adolescents (ages 8-17) with a~     primary diagnosis of OCD will be screened and, should they meet relevant criteria, randomly~     assigned to one of two treatment conditions: (1) CBT plus DCS, or (2) CBT plus placebo. All~     patients will receive 10 sessions of CBT A rater will assess participants at 3 separate time~     points.~   "
206071|NCT00864110|"~     This is a multi-center Phase 1 b study designed to expand the patient safety using~     99mTc-EC-DG with SPECT/CT imaging and to expand the patient radiation dosimetry and~     pharmacokinetic database using 99mTc-EC-DG in patients who have non-incisional biopsy~     definitive evidence of Non-small Cell Lung Cancer as compared to 18F-FDG PET/CT imaging.~   "
206074|NCT00864071|"~     To compare the rate and extent of absorption of griseofulvin from a test formulation of~     Griseofulvin 125 mg/5 mL Suspension versus the reference Grifulvin V® 125 mg/5 mL Suspension~     under fasting conditions.~   "
206077|NCT00864032|"~     Patients will receive neoadjuvant sorafenib (investigational agent) in combination with~     preoperative external beam conformal radiotherapy (50 Gy in 25 fractions) for localized,~     large soft tissue sarcomas of the extremity and body wall prior to resection with curative~     intent. Sorafenib is an FDA-approved targeted agent for patients with renal cell carcinoma~     and hepatocellular carcinoma. Preliminary data suggest activity for sorafenib against soft~     tissue sarcoma in the metastatic setting. Limited data are available regarding the safety and~     efficacy of sorafenib in combination with radiotherapy.~      The Phase I portion of the trial will seek to establish the safety of sorafenib and~     radiotherapy in the neoadjuvant setting for soft tissue sarcomas of the extremity and body~     wall. The Phase II portion of the trial will aim to determine the pathologic~     near-complete/complete response rate (≥ 95% tumor necrosis) of this multimodality therapy.~     Molecular and dynamic contrast-enhanced MRI studies will seek to establish correlative~     biological and imaging markers of response and/or resistance to this therapy.~   "
206078|NCT00864019|"~     To compare the rate of absorption and oral bioavailability of a test formulation of~     Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent~     oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer~     Inc. Following an overnight fast of at least 10 hours, subjects will consume a standard~     high-calorie, high-fat breakfast meal. This standard breakfast will begin 30 minutes prior to~     each dose.~   "
206079|NCT00864006|"~     The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG~     delayed release tablets.~   "
206080|NCT00863993|"~     The aim of this study is to assess whether activity thermogenesis increases in patients~     undergoing bariatric surgery post-operatively compared to pre-operatively. The investigators~     will assess non-exercise activity thermogenesis using a validated Physical Activity~     Monitoring System and doubly labeled water, immediately pre-operatively and again at 6 and 18~     months post-operatively. PAMS has been validated in lean and obese individuals. This is to~     assess energy expenditure, activity thermogenesis and NEAT during the phase of greatest~     weight loss and once weight loss has plateaued. This will permit us to address our primary~     hypothesis that activity thermogenesis as a fraction of total daily energy expenditure~     increases in patients undergoing bariatric surgery 6 and 18 months post-operatively, compared~     to pre-operatively.~   "
206081|NCT00863980|"~     This study is aimed to investigate whether treatment with Telmisartan is more effective than~     Candesartan in reducing the ischemic cardiovascular events in high-risk patients with~     cardiovascular disease.~   "
206082|NCT00863967|"~     Arteriosclerosis is a common chronic disease with well known risk factors like diabetes~     mellitus, hypertension, dyslipidemia, adipositas and smoking, leading to severe complications~     like myocardial infarction, stroke or peripheral arterial occlusive disease. In addition to~     life-style factors there is also a genetic predisposition to develop complicated~     atherosclerosis.~      Objective: Improve individual risk prediction by clinical phenotyping and genotyping.~   "
206083|NCT00863954|"~     The purpose of this study is to see if using a device called the Resonator, that puts out a~     very low electromagnetic field, effects blood glucose and A1c levels in people with Type 2~     Diabetes.~   "
206084|NCT00863941|"~     To compare the rate and extent of absorption of Abrika Bupropion 150 mg XL Tablet to that of~     Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in fasted subjects.~   "
206085|NCT00863928|"~     This study is evaluating the effect of a Belladonna and Opium suppository administered~     intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate~     cancer. This is a blinded randomized study. 50% of patients will receive the suppository, 50%~     of patients will not. Neither you or your surgeon will know which group you are in.~   "
206086|NCT00863915|"~     To compare the rate of absorption and oral bioavailability of a test formulation of~     Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral~     dose of the commercially available reference product Atlace® manufactured by Monarch~     Pharmaceuticals Inc. administrated as a sprinkle on one tablespoonful of applesauce to~     healthy subjects after a 10-hour overnight fast~   "
206087|NCT00863902|"~     To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations~     after administration of single doses to normal healthy subjects under fed conditions. These~     data were to be evaluated statistically to determine if the products meet bioequivalence~     criteria.~   "
206088|NCT00863889|"~     The objective of this study is to conduct a randomized, single-blinded placebo controlled~     trial comparing two modalities for the treatment of pain and mobility associated with~     trochanteric bursitis: (1) injection of glucocorticosteroid and local anesthetic, (2)~     injection of local anesthetic. We hope to determine whether steroid injections provide a~     statistically significant improvement in pain symptoms and hip mobility in subjects with~     trochanteric bursitis, as compared to an injection of local anesthetic. Our null hypothesis~     is that no statistically significant difference exists between the two treatment modalities.~   "
206089|NCT00863876|"~     Comparison of repeated WaveLight Analyzer and Alcon LadarWave measurements in phakic and~     pseudophakic eyes.~   "
206090|NCT00863863|"~     To compare the rate and extent of absorption of griseofulvin from a test formulation of~     Griseofulvin 125 mg/5 mL Suspension versus the reference Grifulvin V® 125 mg/5 mL Suspension~     under fed conditions.~   "
206091|NCT00863850|"~     An Open-Label Study to Investigate the Pharmacokinetics of Bendamustine Hydrochloride in~     Patients With Relapsed or Refractory Malignancy (Hematologic or Nonhematologic)~   "
206105|NCT00863655|"~     There are no treatments specifically approved after recurrence or progression on a non~     steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for~     postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study~     is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane +~     placebo in postmenopausal women with estrogen receptor positive locally advanced or~     metastatic breast cancer refractory to NSAI.~   "
206106|NCT00863642|"~     While there exists consensus among surgeons that patients with gallstone pancreatitis should~     undergo cholecystectomy to prevent recurrence, the precise timing of laparoscopic~     cholecystectomy for mild to moderate disease remains controversial. We hypothesize that~     laparoscopic cholecystectomy performed within 48 hours of admission, regardless of resolution~     of abdominal pain or abnormal laboratory values, will result in a shorter hospital stay.~   "
206092|NCT00863837|"~     BACKGROUND: Previous studies showed that the combination of endoscopic therapy with~     vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in~     achieving the successful hemostatsis of acute variceal bleeding. The rationale of using~     vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays,~     endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as~     the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage.~     EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage.~     However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that~     prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical~     than using a vasoconstrictor after cessation of bleeding by EVL.~      Thus, the investigators designed a controlled trial to compare the initial hemostasis, early~     rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving~     either emergency EVL plus vasoconstrictor infusion or losec infusion for 5 days.~   "
206093|NCT00863824|"~     The purpose of the study is to investigate how long it takes for NNAL and cotinine, both~     specific markers of second hand tobacco smoke exposure to clear the human body.~   "
206094|NCT00863811|"~     Elevated intraocular pressure is still the main risk factor for development and progression~     of glaucoma. Several drugs exist on the market that may decrease IOP in glaucomatous~     patients. However, some patients cannot reach the target pressure despite a multitherapy with~     a combination of drugs, and are therefore addressed to surgical treatments. Forskolin is a~     natural compound that is a receptor-independent adenyl-cyclase activator, that increases~     intracellular cAMP. It has been shown to be able to decrease IOP after topical application,~     by a mechanism that is not used by the other drugs. Aim of the present study is to see~     whether oral administration of a food supplement containing forskolin (KRONEK) has any effect~     on the IOP of POAG patients with stable IOP obtained by treatment with either beta-blockers~     or prostaglandins.~   "
206095|NCT00863798|"~     The primary purpose of this study is to compare the antidepressant efficacy and safety of two~     doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major~     Depressive Disorder. The study will also assess changes in sexual function and general and~     functional quality of life outcomes.~   "
206096|NCT00863785|"~     35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6~     months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter~     more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by~     administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C)~     could make the hepatocytes more resistant and improve survival. The investigators' study's~     primary endpoint was improvement of survival at 6 months. The secondary endpoints were~     survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7~   "
206097|NCT00863772|"~     Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted~     in sensory nerves.~   "
206098|NCT00863759|"~     Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified~     anterior and posterior aspherical surface (Akreos AO, Bausch & Lomb,Inc) results in reduced~     ocular aberrations (spherical aberration) and in improved contrast sensitivity after cataract~     surgery.~      Study hypothesis: the implantation of an intraocular lens (IOL) with a modified anterior and~     posterior aspherical surface (Akreos AO, Bausch & Lomb,Inc) results in reduced ocular~     aberrations (spherical aberration) and improved contrast sensitivity after cataract surgery.~      Setting: Department of ophthalmology, Hospital das Clínicas, University of São Paulo, São~     Paulo, Brazil.~      Overall Study design: This will be an intraindividual randomized double-blinded prospective~     study. Patients will be randomized to receive an aspheric IOL Akreos AO in one eye (25 eyes;~     Bausch & Lomb, Inc), and an spheric IOL Akreos Fit (25 eyes; Bausch & Lomb, Inc.) in the~     fellow eye. Ocular aberrations with a 5.0 mm and 6.0 mm pupil will be measured with a dynamic~     retinoscopy aberrometer after 1 and 3 months. Uncorrected and best-corrected visual acuity,~     out-focus performance and contrast sensitivity under mesopic and photopic conditions will be~     also measured. All patients will be followed for 3 months.~   "
206099|NCT00863746|"~     The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition~     to the non-cancer treatments patients would normally receive) is an effective treatment for~     lung cancer compared to best supportive care alone. The safety and tolerability of the two~     treatment groups will also be compared. The goal of the study is to test the ability of~     sorafenib to improve survival compared to best supportive care alone.~   "
206100|NCT00863733|"~     This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid~     tumors.~   "
206101|NCT00863707|"~     This study is intended to assess the safety and tolerance of regadenoson in subjects with~     renal impairment.~   "
206102|NCT00863694|"~     Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis~   "
206103|NCT00863681|"~     Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934)~     will be asked to participate in this long term extension study with BAY63-2521.~   "
206104|NCT00863668|"~     The reduction with antiretroviral therapy (ART) of HIV RNA in blood, and HIV RNA in infected~     cells and in viruses associated with the follicular dendritic cell (FDC) network in lymphatic~     tissues, typically follows a two-phase pattern of decline. The half-life of the first-phase~     is about 1 day and that of the second phase is about 14 days, with comparable estimates for~     first-phase decay in SIV-infected rhesus macaques.~      While substantial evidence supports the current view that first-phase decay reflects the~     death of activated CD4+ T cells infected before ART was begun, the sources of viral RNA in~     the second phase have not as yet been conclusively established. Possible sources of viral RNA~     that have been invoked in mathematical models, or for which there is experimental evidence,~     include longer-lived infected cells such as macrophages and resting CD4+ T cells,~     dissociation of virus from the FDC network, and productively infected CD4+ T cells that are~     not subject to clearance by host immune responses because of waning levels of HIV antigen.~      Raltegravir (MK-0518) belongs to a new class of integrase inhibitors that potently suppress~     HIV and SIV replication, and reportedly markedly alters the second phase HIV decline in a way~     that challenges the current view that longer-lived infected cells are the source of virus in~     this phase. While mathematical modeling of decay of HIV RNA in blood was most consistent with~     1) cells newly infected by long-lived cells, or 2) from activation of latently infected cells~     with full-length unintegrated HIV DNA as a source of second phase virus, we think the data~     are also quite consistent with the greater efficacy of integrase inhibitors in a particular~     cell type and/or anatomic site such as the gut.~      In this protocol we will test the hypothesis that the rapid decrease in HIV replication~     associated with raltegravir is due to a more complete suppression of viral replication in~     lymphatic compartments such as lymph nodes and gastrointestinal lymphatic tissue. We will~     also investigate compartment-specific intracellular levels of raltegravir to potentially~     explain differences in changes in these compartments.~   "
208335|NCT00834054|"~     Repeated measurements of lung water by single transpulmonary thermodilution during the first~     postoperative days following lung transplantation~   "
206107|NCT00863629|"~     Objectives. The investigators analysed the effects of tight glycemic control in regenerative~     potential of the myocardium during acute myocardial infarction (AMI).~      Background. A strict glycemic control after AMI improves the cardiac outcome. The role of~     tight glycemic control in regenerative potential of the myocardium during acute myocardial~     ischemia are still largely unknown.~      Methods. Sixty-five patients with first AMI undergoing coronary bypass surgery were studied:~     25 normoglycemic patients served as control group; hyperglycemic patients (glucose >140~     mg/dl) were randomized to intensive glycemic control (IGC, n=20; glucose goal 80-140 mg/dl)~     or conventional glycemic control (CGC, n=20; glucose goal180-200 mg/dl) for almost 3 days~     before surgery, using insulin infusion followed by subcutaneous insulin treatment.~     Echocardiographic parameters were investigated at admission and after treatment period.~     During surgery, oxidative stress (nitrotyrosine, O2- production), apoptosis (Caspase-3) and~     cardiac stem cells (CSCs) (c-kit, MDR1 and Sca-1 positive cells) were analysed in biopsy~     specimens taken from the peri-infarcted area.~   "
206108|NCT00863616|"~     Patients with Chronic obstructive pulmonary disease (COPD) tend to have cough, excess mucus~     production and breathlessness as cardinal features. The excess mucus production often leads~     to frequent infections, exacerbations and poor quality of life. Mucociliary clearance may~     have an impact on improving symptoms, exercise tolerance, quality of life and reduce~     exacerbations.~      High frequency chest wall oscillation(HFCWO) devices use percussion to the chest wall~     delivered from a pump through a close fitting inflatable vest. This technique has been shown~     to enhance mucus clearance in patients with cystic fibrosis and Bronchiectasis. This pilot~     study was designed to explore the feasibility, tolerance and effectiveness of the HFCWO in~     patients with advanced COPD.~   "
206109|NCT00863603|"~     Many grafts placed for dialysis access fail which causes patients to undergo additional~     operations, decreases their quality of life, and increases health care costs. The purpose of~     this study is to see if dialysis access grafts will function longer for patients who receive~     additional oxygen by means of a nasal cannula for 42 days after placement of their graft.~      Patients will have periodic blood tests to measure oxygen levels in their blood. A series of~     ultrasound examinations of patient's dialysis grafts will be taken to ensure the graft is~     open and to measure the cellular proliferation (intimal hyperplasia) for comparison in those~     receiving extra oxygen and those with no oxygen.~   "
206110|NCT00863590|"~     This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib~     (MK0822) with and without food.~   "
206111|NCT00863577|"~     The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa~     activity~   "
206112|NCT00863564|"~     The purpose of this study is to determine the effects of dietary protein on blood lipids and~     gut hormones after a fat-rich meal.~      Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream~     following a fat rich meal. The effect is dependant of both the quality and the quantity of~     protein ingested.~   "
206113|NCT00863551|"~     This study evaluates the penetration through the blood-brain-barrier of trospium chloride at~     plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium~     levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured.~     Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change~     index to assess if any study subject shows evidence of a clinically and statistically~     significant change in memory.~   "
206114|NCT00863538|"~     To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with~     SCD~   "
206115|NCT00863525|"~     This study will assess the safety and tolerability of single doses of odanacatib (MK0822)~     when administered with a light breakfast.~   "
206116|NCT00863512|"~     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel,~     gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Sometimes after~     surgery, the tumor may not need more treatment until it progresses. In this case, observation~     may be sufficient. It is not yet known whether chemotherapy is more effective than~     observation in treating patients who have undergone surgery for stage I non-small cell lung~     cancer.~      PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how~     well they work compared with observation in treating patients with early stage non-small cell~     lung cancer.~   "
206117|NCT00863499|"~     The aim of the iSPOT-A study is to:~        1. identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity~          Disorder, and~        2. identify brain, genetic and cognitive markers that predict treatment response to~          short-acting methylphenidate in children and adolescents diagnosed with Attention~          Deficit/Hyperactivity Disorder.~   "
206118|NCT00863473|"~     1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in~          patients aged over 60 compared to a standardized conservative treatment gain a better~          functional outcome after one year?~        2. Do surgical treatment gain more QALY than conservative treatment after one year?~   "
206119|NCT00863460|"~     Purpose of the study :~      To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their~     respective toxicity on the CNS.~   "
206120|NCT00863434|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving clofarabine together with cytarabine may kill more cancer cells.~      PURPOSE: This pilot phase II trial is studying how well giving clofarabine together with~     cytarabine works in treating patients with acute myeloid leukemia with minimal residual~     disease~   "
206149|NCT00863057|"~     Neuropathy results from damage to the nerves in the feet and legs. It is usually experienced~     as pain, tingling or numbness. In HIV-infected people, neuropathy can result from the~     infection itself or be a side effect of antiretroviral treatment. The purpose of this study~     is to determine whether two different drugs, methadone and duloxetine, reduce~     neuropathy-associated pain in HIV-infected people. This study will also examine whether~     utilization of both of these drugs is more effective than treatment with only one.~   "
206150|NCT00863044|"~     This study is to test the safety of high frequency-low volume ventilation during off pump~     coronary artery bypass as reflected in the near infrared spectroscopy values for cerebral~     oxygenation.~   "
206121|NCT00863421|"~     Only few prospective studies systematically investigated the prevalence of sleep disordered~     breathing in patients with stable chronic heart failure. Furthermore there is no report on~     the incidence rate of sleep disordered breathing in this population. This is a prospective~     multi-centre study of sleep-disordered breathing in 200 patients with stable~     moderate-to-severe chronic heart failure. Eligible patients will undergo overnight full-night~     polysomnography, lung function testing, laboratory measurements, and hemodynamic recordings.~     Measurements will be repeated at 6 months interval for a follow-up period of two years~     irrespective of the presence or absence of sleep disordered breathing. The primary outcome~     variable for this study is the prevalence of sleep disordered breathing in the study~     population. Secondary outcome variables include the 2-year incidence rate of sleep disordered~     breathing, quality of life measurements, exercise capacity, sleep quality, hemodynamic~     measurements, and laboratory markers of neurohumoral activation, systemic inflammation, and~     endothelial function in the study population.~   "
206122|NCT00863408|"~     Background:~        -  P. falciparum, one of the most virulent forms of malaria, causes more than 300 million~          episodes of malaria and 1 million deaths each year. The spread of drug-resistant~          parasites, insecticide-resistant mosquitoes, and persistent socioeconomic conditions of~          poverty compound the difficulties of malaria as a major global health problem. New means~          of disease and vector control are vitally needed.~        -  Several promising strategies rely on targeting mosquito populations when they are most~          vulnerable, such as during the dry season when mosquitoes find it difficult to~          reproduce. Large regions of the West African country of Mali have prolonged dry seasons~          (up to 8 months), during which mosquito populations dramatically decline within a month~          after the rainfall ceases. Clearly, mosquitoes can survive the dry season (as evident~          from their robust numbers during the wet season) but the process that enables them to do~          so remains unknown. Targeting the small and fragile mosquito population at the end of~          the dry season could reduce or eliminate the numbers of mosquitoes in certain regions,~          providing great benefits for communities in dry regions.~      Objectives:~        -  To determine if common malaria-carrying mosquitoes survive the dry season in the Mali~          village of Thierola by estivation (going dormant, or hibernating, during dry periods).~        -  To identify and examine mosquitoes that were marked with special paint during a previous~          protocol, if these marked mosquitoes are captured during the investigation.~      Eligibility:~        -  All activities in this protocol will take place in Thierola village, Banamba district,~          Koulikoro region, Mall, West Africa. The village was chosen because it is isolated from~          other communities by at least 6 km and is a small community of less than 300 inhabitants~          living in 90 houses.~        -  Participants will be healthy adult men between 18 and 65 years of age.~      Design:~        -  Thirty adult men who live in Thierola will be recruited to participate as mosquito~          collectors for the human-baited trapping method and will work in teams of two.~        -  The first collector will expose his lower legs to attract human-seeking mosquitoes.~          Using a mouth aspirator, the second collector will collect the mosquitoes as they land~          on the first collector's legs.~        -  The collections will be conducted both indoors and outdoors from 6 p.m. to 6 a.m. the~          following morning for 14 consecutive days.~        -  All study volunteers will be trained in proper collection technique and supervised~          throughout the study by a mobile team led by the study investigators. Volunteers will be~          monitored for signs of malaria and treated accordingly if they develop symptoms of the~          disease.~        -  Researchers will collect mosquito samples at the end of the dry season (April-May) and~          at the start of the rainy season (May-June).~        -  Mosquitoes collected in the study will be analyzed by NIH researchers to learn more~          about how they survive during the dry season.~   "
206123|NCT00863395|"~     The purpose of this study is to define the mechanisms that underlie the refractory pruritus~     (itch) in Cutaneous T-Cell Lymphoma (CTCL).~   "
206124|NCT00863382|"~     Ablation of atrial fibrillation is a well established treatment method to restore normal~     sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation.~     Absence of symptomatic and asymptomatic atrial fibrillation should be considered necessary~     for discontinuation of anticoagulation therapy. Presently, recurrence of atrial fibrillation~     is usually determined with the use of a non looping event monitor which is typically used by~     the subject at the time of symptomatic arrhythmia. This method does not detect asymptomatic~     atrial fibrillation. Random asymptomatic recording can be added, but the chance for detecting~     recurrence of arrhythmia is not great. Too frequently, the success rates of AF ablation~     procedures are inflated by insufficient follow up and patient's limited compliance in~     reporting and recording episodes of recurrent arrhythmias. Often times, it is very~     inconvenient for patients to wear external event recorders. Allergies to the sticky pads that~     are needed for most of the external monitoring devices continues to be a problem. Implantable~     loop recorders have the advantage of detecting symptomatic and asymptomatic atrial~     fibrillation continuously. They also offer the convenience of monitoring for up to 18 to 24~     months without significant patient discomfort. However, implantation and explantation of~     these devices involves a limited surgical procedure as well as considerable experience. In~     this study we attempt to assess the differences in these two types of monitoring systems in~     assessing the long term efficacy of AF ablation.~   "
206125|NCT00863369|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer~     growth in different ways. Some block the ability of cancer cells to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them. Giving~     bortezomib together with gemcitabine hydrochloride and rituximab may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib and~     gemcitabine hydrochloride when given together with rituximab and to see how well they work in~     treating patients with progressive or relapsed B-cell non-Hodgkin lymphoma.~   "
206126|NCT00863356|"~     Purpose:~      This study is a prospective clinical trial to investigate the efficacy of a chitosan-coated~     nasal packing (ChitoFlex® used in conjunction with the HemCon Nasal Plug) in the management~     of difficult spontaneous epistaxis and to evaluate its healing effect on nasal mucosa.~      The introduction of products that enhances hemostasis can have clinical advantages when~     associated with traditional nasal packing. These advantages include a better hemostatic~     control and the reduction of nasal packing duration. Furthermore, this study will help~     determine if there are any non-desirable effects that chitosan may have on the nasal cavity,~     such as the production of fibrosis and foreign body reaction.~   "
206127|NCT00863343|"~     The primary objective of this study is to evaluate the performance of the MSD® Influenza Test~     in detecting influenza A and influenza B in subjects presenting with influenza-like-illness~     (ILI).~   "
206128|NCT00863330|"~     RATIONALE: Treating lymphocytes in the laboratory may help the lymphocytes kill more tumor~     cells when they are put back in the body. Aldesleukin may stimulate the lymphocytes to kill~     tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving laboratory-treated lymphocytes and aldesleukin together with~     cyclophosphamide and fludarabine may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well laboratory-treated autologous lymphocytes~     and aldesleukin work when given after cyclophosphamide and fludarabine in treating patients~     with metastatic melanoma.~   "
206129|NCT00863317|"~     The primary rationale for this study is to evaluate the effect of once daily montelukast on~     duration of acute illness in infants with first-time bronchiolitis.~   "
206130|NCT00863304|"~     Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in~     patients with osteoarthritis~   "
206151|NCT00863031|"~     The aim of this study was to determine whether screening followed by brief PSC provided by~     primary care doctors could improve the quality of life of elderly patients with unrecognized~     psychological problems in primary care. The following hypotheses were tested:~        1. Elderly patients screened positive of psychological problems had poorer health-related~          quality of life (HRQOL) than those who were screened negative.~        2. Primary care doctors could be trained to provide brief PST.~        3. Brief PST by a trained primary care doctor could improve the HRQOL of the elderly who~          were screened positive for psychological problems.~   "
206152|NCT00863018|"~     The purpose of this trial is to study the change in corneal endothelial cell after glaucoma~     surgery, non-contact specular microscopic examination is performed for the patients who~     underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery~     prospectively. Change in corneal endothelial cell density, hexagonality, and coefficient of~     variation of cell area will be analyzed and compared to the baseline and between the types of~     the surgeries.~   "
219082|NCT00691366|"~     The purpose of this research is to study heart rate patterns in people with moderate to~     severe atopic dermatitis and how itching affects those patterns.~   "
206131|NCT00863291|"~     The acutely suicidal patient presents a complex and dangerous clinical dilemma. Many suicidal~     patients receive antidepressant medications, but the onset of action of these medications is~     at least three weeks, and despite their established antidepressant effect, they have not~     shown a clear anti-suicidal benefit. Psychoanalysts hypothesized that depression (often~     leading to suicidality) shares important characteristics with the psychological sequellae of~     object loss and separation distress. Endogenous opioids (endorphines) have been implicated in~     mediating social bonding and separation distress in mammals. Anecdotal evidence and several~     clinical studies found the mixed opioid agonist-antagonist buprenorphine to be an effective~     antidepressant with a rapid onset of action. It is therefore hypothesized that buprenorphine~     may be a novel and quick-acting treatment for acute suicidality, especially in the context of~     depression. The proposed double-blind study will examine the effect of buprenorphine on~     acutely suicidal inpatients. Depression, suicidality, and overall functioning will be~     assessed before, during and after a two-week buprenorphine/placebo trial. A small subgroup of~     patients will also be treated with short-term psychoanalytic psychotherapy throughout the~     study period. It is hypothesized that subjects who receive the active drug will show rapid~     improvements in objective and subjective measures of suicidality and depression.~   "
206132|NCT00863278|"~     Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on~     the face. Treatment is difficult and to date the best treatment option is the combination of~     hydroquinone, retinoic acid and steroids combined in topical daily application (called~     Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post~     inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but~     also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be~     effective in treating some pigmentary defects. Associating blanching cream with hydroquinone~     to prevent PIH after laser or intense pulsed light has been already reported with success.~      The objective of the study is to compare in a prospective intra individual comparative trial~     the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone.~     The secondary objective was to study the frequency and the intensity of the potential side~     effects including PIH.~   "
206133|NCT00863265|"~     Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear~     to have different mechanisms of action. The investigators hypothesis is that phytosterols and~     ezetimibe given together will block cholesterol absorption nearly completely. The~     investigators will perform a randomized, placebo-controlled crossover feeding study in 25~     subjects with greater than ideal levels of LDL cholesterol who do not require~     anti-cholesterol drug treatment. Subjects will consume a baseline diet provided by a feeding~     center that is deficient in phytosterols for three periods of 21 days in random order. During~     period I placebo phytosterols and placebo ezetimibe will be given; during period II placebo~     phytosterols and active ezetimibe will be given; during period III active phytosterols and~     active ezetimibe will be given. Study endpoints are fecal cholesterol excretion and percent~     cholesterol absorption determined by gas chromatography/mass spectrometry, circulating~     phytosterol levels and circulating LDL cholesterol levels.~   "
206134|NCT00863252|"~     IgA nephropathy (IgAN) is the commonest primary glomerulonephritis worldwide. In Hong Kong,~     IgAN accounts for approximately 30% of all primary glomerular diseases, and a significant~     proportion of young patients (< 50 years of age) on dialysis therapy are sufferers of primary~     IgAN. To date, no specific therapeutic agent has been consistently shown to halt the~     progression of IgAN to end-stage renal failure, particularly in patients with persistent~     significant proteinuria and the presence of chronic tubulointerstitial inflammation on kidney~     biopsy. In recent years, angiotensin-converting enzyme inhibitors (ACEI) have been found~     capable of significantly reducing proteinuria in some IgAN patients, while others,~     particularly those with the ACE DD genotype, showed either absent or unsatisfactory response~     to angiotensin blockade. Mycophenolate mofetil (MMF) is a marketed immunosuppressive drug~     which acts by releasing mycophenolic acid (MPA) to inhibit the de novo pathway of purine~     synthesis, and hence is relatively selective for lymphocytes. Apart from being efficacious~     for the prophylaxis of renal allograft rejection and for the induction of remission in severe~     lupus nephritis, MMF has been anecdotally reported to avert progression to allograft failure~     in recurrent IgAN of the transplanted kidney. Data on the clinical efficacy of MMF in the~     treatment of primary IgAN, however, is lacking. In the current proposal, we aim to study the~     clinical efficacy of MMF in patients with biopsy-proven IgAN and clinically significant~     proteinuria despite angiotensin blockade. Patients will be followed up for at least 5 years~     to track any survival difference between groups.~   "
206135|NCT00863239|"~     The purpose of the study was to assess in subjects with chronic hepatitis C (treatment-naïve,~     genotype 1) receiving weight-based doses of ribavirin the virologic response to 3 dose levels~     of Locteron™, dosed every 2 weeks, in comparison with PEG-Intron™ dosed weekly.~   "
206136|NCT00863226|"~     The purpose of this study is to see if a device called the Resonator can help to improve~     aspects of health and quality of life that are relevant to patients with Parkinson's disease.~   "
206137|NCT00863213|"~     The purpose of this study is to compare the effectivity and safety of atrial fibrillation~     ablation, in comparison to antiarrhythmic drug therapy in patients with refractory,~     persistent atrial fibrillation.~   "
206138|NCT00863200|"~     The goal of this research study is to learn how well a telephone system works for improving~     the management of emotional distress, sadness, and/or depression in patients who are being~     treated for cancer.~   "
206153|NCT00863005|"~     The purpose of the study is the assessment of the barrier impairment, clinical skin condition~     and bacterial colonization status in patients with atopic eczema following topical treatment~     with K201 cream and a comparator twice daily over a 4-week treatment period.~   "
206154|NCT00862992|"~     The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed~     doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets~     will be administered to patients starting at an initial dose, followed by up-titration to a~     fixed dose (low, medium or high) for 14 days.~   "
206155|NCT00862979|"~     This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and~     mycophenolic acid is associated with a better renal outcome as compared to the standard~     regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while~     both treatments are expected to be comparable with respect to efficacy.~   "
206139|NCT00863187|"~     Background:~      The ability of the immune system to function declines with aging. This is reflected by a~     marked decrease in the responsiveness to vaccinations and to infectious agents.~     Consequentially, there is a profound reduction in the quality of live and an increased~     dependency on the health systems. Studies have shown that the production of B lymphocytes in~     the bone marrow declines with aging and long-lived B cells accumulate in the periphery. Thus,~     instead of a juvenile repertoire of B cells that is capable to recognize any new pathogen,~     the repertoire of the elderly becomes more restricted and fails to respond to new antigens.~      Working hypothesis and aims: We hypothesize that the dramatic change in the cellular~     composition in aging reflects homeostasis pressures that are set by long-lived peripheral B~     cells. Here, the investigators hypothesize that altering the homeostasis, by active depletion~     of the peripheral B cells, will revive B lymphopoiesis in the BM and rejuvenate the~     peripheral repertoire of B cells in aging. Consequentially, this will significantly improve~     immune responsiveness of aged individuals to new antigenic challenges.~      Methods:~      The investigators propose a parallel study in human and mouse. For our clinical study we will~     use old lymphoma patients that were treated with the B cell depleting therapy, RITUXIMAB, for~     transient B cell depletion and established full B cell reconstitution. We will test the~     responsiveness of these patients to hepatitis B vaccine and compare it to aged-matched~     control group. The investigators will also use old human CD20 transgenic mice where B cell~     depletion is imposed by anti human CD20 antibodies. In these experiments we will study~     physiological and immunological changes to understand aging mechanisms in the B lineage.~      Expected results: We expect that old patients treated for B cell depletion will have an~     increased responsiveness to the hepatitis B vaccine relative to the control group.~      Importance:~      The investigators propose an efficient approach to improve immune response in the elderly~     population. This will increase efficacy of vaccination, reduce morbidity and improve quality~     of life. It will also reduce the cost of medical treatment. In addition, this study will show~     that senescence in the B lineage can be reversed, which is in contrast to the general~     concepts of aging.~      Probable implications to the welfare and health of the aged population Medicine:~      Improving the immune competence will increase efficacy of vaccination, reduce morbidity, and~     reduce dependency on health systems. This will significantly improve the quality of life.~   "
206140|NCT00863174|"~     Safety and bioequivalence of SPARC_147709~   "
206141|NCT00863161|"~     The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and~     leaves the blood in people with normal kidney function or with different degrees of reduced~     kidney function.~   "
206142|NCT00863148|"~     Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its~     efficacy in treating aggressive acute leukemias. In addition, evidence is that it is~     well-tolerated with manageable side effects especially in elderly patients. Thus, replacing~     Fludarabine with Clofarabine in a reduced intensity transplant regimen may provide a regimen~     with increased anti-tumor activity without adding significant risks of toxicity.The purpose~     of this study is to evaluate the efficacy and the safety of clofarabine in combination with~     IV busulfan and ATG as the backbone of a reduced intensity conditioning regimen for~     allogeneic stem cell transplantation for the treatment of patients with high-risk MDS/AML or~     ALL not eligible to conventional or standard myeloablative allo-SCT.~   "
206143|NCT00863135|"~     The purpose of this study is to determine the effects of CPAP treatment on blood pressure in~     patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH).~      Also, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress,~     sympathetic hyperactivity) will be analyzed.~   "
206144|NCT00863122|"~     Tumors can grow on the auditory nerves and can cause hearing loss. A common type of tumor~     that does this is a vestibular schwannoma (VS), or acoustic neuroma. These tumors are not~     cancerous. Most often, people have only one VS. Occasionally, people have more than one VS~     and may have a condition called neurofibromatosis type 2 (NF2).~      Because VS can cause hearing loss, many people with VS will have treatment to preserve their~     hearing. This treatment usually involves surgery or radiation therapy. There are risks to~     these procedures, and sometimes they do not work to prevent hearing loss. Because surgery and~     radiation have risks and are not able to help everyone with VS, other methods of treatment~     are being explored. One area of exploration is looking to see if there is a drug that can be~     taken that might prevent the VS from growing larger and causing hearing loss, and might~     possibly even cause the VS to shrink in size.~      This study is exploring whether a drug that is approved by the FDA and is currently used to~     treat breast cancer might also work to treat VS. This study will measure the amount of drug~     that travels from the bloodstream and arrives at the tumor. This drug is safe and has few~     side effects. If this drug is shown to reach the tumor, it might be used in the future to~     treat VS without needing surgery or radiation.~      This study is recruiting people who are having surgery for VS. If you are going to have~     surgery to treat a VS, you may be eligible to participate.~   "
206145|NCT00863109|"~     The primary objective of this study is to evaluate the impact of chronic hepatitis C (CHC),~     and the treatment thereof with peginterferon alpha-2b (PEG) and ribavirin (RBV) according to~     standard clinical practice, on the health-related quality of life (HRQL) of a cohort of~     participants throughout 72 weeks of follow-up. HRQL was assessed using the 36-Item Short-Form~     Health Survey (SF-36) and the Chronic Liver Disease Questionnaire-Hepatitis C Virus~     (CLDQ-HCV).~   "
206146|NCT00863096|"~     Public Health Research Institute (PHRI) is carrying out a 15 month research and advocacy~     project with the goals of generating critical data on acceptability, identifying determinants~     and facilitators of HPV vaccine uptake in adolescent girls; and investigating physicians'~     attitudes to identify predictors of intention to recommend immunization in Mysore, India.~   "
206147|NCT00863083|"~     The purpose of the study is to examine the extent to which two different reward systems~     implemented in the context of a multi-family pediatric weight management group differentially~     promote adoption of healthy eating and activity habits among overweight and obese 8-17 year~     old youth. Participants will be randomly assigned to one of two reward conditions: rewards~     for attendance only or rewards for attendance and goal attainment. We hypothesize that all~     participants will demonstrate significant increases in healthy nutritional choices and~     physical activity and significant reductions in sedentary activity from pre-intervention to~     post intervention. We expect that participants in attendance plus goal attainment reward~     condition will demonstrate significantly greater improvements than participants in the~     attendance only condition.~   "
206148|NCT00863070|"~     The purpose of this study is to determine whether patients who have undergone exstrophy~     closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. This~     study is a descriptive analysis of the study cohort's gait patterns and pelvic structure.~      Specific Aim 1: to determine whether patients with classic bladder exstrophy who underwent~     closure demonstrate gait abnormalities.~      Hypothesis 1: Patients undergoing closure of bladder exstrophy (with or without pelvic~     osteotomy) demonstrate gait abnormalities compared with a reference population.~      Hypothesis 2: Patients undergoing closure of bladder exstrophy (with or without pelvic~     osteotomy) will have below normal functional survey scores.~   "
206156|NCT00862966|"~     The purpose of this study is to determine whether the application of 47% citrate lock~     solution decreases the incidence of infection and thrombosis of central venous catheter in~     hemodialysis population.~   "
206157|NCT00862953|"~     This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the~     evaluation and treatment of subjects with obesity. The program puts emphasis on intervention~     with appropriate diet and physical exercise, and supports the patients in achieving long-term~     behaviour changes. Interventions which are compared are normal vs high protein/low carb~     diets.~   "
206158|NCT00862940|"~     Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity~     associated with excessive glutamate release and calcium overload in neurons. Previous studies~     have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the~     rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go~     hand in hand with some of the symptoms of the disease. This suggests that memantine treatment~     in AD could provide both symptomatic improvement and neuro-protective effects. The purpose of~     this study was to show whether memantine, in addition to providing symptomatic benefits, can~     slow the rate of brain atrophy as assessed using magnetic resonance imaging (MRI) technology.~   "
206159|NCT00862927|"~     The objectives of this proposal are to examine the role of context in a virtual reality (VR)~     environment and to explore the extent to which cues (i.e., contextual cues or explicit~     smoking cues) influence craving and physiological arousal within VR.~      The current study seeks to determine whether smokers, placed in the context of a VR~     convenience store devoid of explicit smoking cues, will experience less craving and~     physiological arousal, compared to exposure to the same VR environment containing explicit~     smoking cues. This important line of inquiry will help clarify the influence of environmental~     contexts that may contribute to the overall reactivity effects (e.g., craving, arousal)~     smokers experience when confronted with cues associated with smoking.~   "
206160|NCT00862914|"~     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length,~     capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs~     (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of~     complementarity. miRNAs have recently been shown to play pivotal roles in diverse~     developmental and cellular processes and linked to a variety of skin diseases and cancers. In~     the present study the researchers investigate the immunohistochemical distribution of Dicer~     in benign and dysplastic melanocytic naevi as well as in cutaneous malignant melanoma~     compared to intraindividual healthy control.~   "
206161|NCT00862901|"~     This research is intended to explore a new approach to therapy when breast cancer recurs in~     the skin. The treatment, known as continuous low-irradiance photodynamic therapy, or CLIPT,~     has shown great promise in animal studies. The investigators goal is to evaluate CLIPT in~     people, using a novel light delivery system, to assess its side effects and the benefit it~     has in treating cancer. The investigators goal is to develop a safe, effective therapy that~     can be given in the doctor's office or possibly at home.~   "
206162|NCT00862888|"~     The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on~     erectile activity in males suffering from erectile dysfunction as well as examining the~     safety and toleration of the drug.~   "
206163|NCT00862875|"~     The objectives is to compare the changes in body composition (primary objective), diabetes~     parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin®~     4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and~     insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type~     2 diabetic patients failing on oral diabetic agents .~   "
206164|NCT00862862|"~     Objective: The objective of the study is to evaluate the ability of current vancomycin dosing~     strategies to attain the pharmacodynamic target of an area under the curve (AUC) to minimum~     inhibitory concentration (MIC) ratio greater than 400:1 for patients with a suspected or~     documented Staphylococcus aureus infection.~      Primary Outcome: The primary outcome is the percentage of vancomycin dosing regimens that~     achieve AUC:MIC ratio > 400 on the first occurrence of vancomycin use in patients with a~     suspected or documented S. aureus infection at The Nebraska Medical Center.~      Secondary Outcomes:~        1. To assess the probability that vancomycin AUC:MIC ratios obtained from The Nebraska~          Medical Center patients exceed a therapeutic threshold using S. aureus MICs from~          isolates obtained from The Nebraska Medical Center.~        2. Using MIC data from the TRUST Study database (large national surveillance database) and~          the vancomycin AUC data obtained from TNMC patients, perform a Monte Carlo analysis that~          will assess the probability of achieving a therapeutic vancomycin threshold with a large~          number of isolates.~   "
206165|NCT00862849|"~     Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved~     medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20)~     is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs.~     In this study, rHuPH20 will be co-administered with both insulin lispro and regular human~     insulin in order to determine if it improves the absorption of these insulins to more closely~     mimic the body's natural increase in insulin in response to a meal.~   "
206166|NCT00862836|"~     This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in~     70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial~     cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national~     centers will participate in phase I of the study. If the starting criteria for phase II of~     the study are met at the end of phase I, a total of approximately 20 national centers will~     participate in phase II of the study.~   "
206183|NCT00862602|"~     Ten to 50% of women with gestational diabetes (GDM), or glucose intolerance first recognized~     during pregnancy, develop diabetes within 5 years after delivery. Although intensive~     interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is~     unknown if such strategies would be effective in women with GDM. Women with recent GDM, even~     though no longer pregnant, face significant barriers to lifestyle modification, including~     caregiving responsibilities and low perception of risk. Web-based programs can reinforce~     physical activity through visual feedback of pedometer output, tailored messaging, education,~     and on-line communities. Such a program is currently available for adults with chronic~     disease and is led by Dr. Richardson, a co-PI on this application. Using data from focus~     group and survey work conducted by Dr. Kim, the other co-PI, this program can be modified to~     women with recent GDM. For Specific Aim 1, we propose to adapt a chronic disease web-based~     pedometer program to women with recent GDM. For Specific Aim 2, we propose to conduct a pilot~     and feasibility study of the program. The intervention will last 12 weeks.~   "
206167|NCT00862823|"~     The primary objective of this study is to determine the average bioequivalence of tenofovir,~     emtricitabine and efavirenz in an extemporaneously prepared oral liquid formulation (test~     formulation) compared with the commercially available tablet formulation (reference~     formulation). The study is designed as an open-label, randomized, 2-period, 2-treatment,~     2-sequence, single-dose intensive pharmacokinetic study conducted in healthy volunteers.~     Subjects will be randomized to receive the Atripla tablet (reference formulation) or the~     Atripla tablet crushed and mixed in OraSweet solution (test formulation) on Study Day 1.~     Subjects will undergo a 12-hour intensive pharmacokinetic evaluation after ingesting a single~     dose of either the test or reference formulation. On days 2 and 3, subjects will provide an~     additional pharmacokinetic sample 24 and 48 hours post dose, respectively. Subjects will~     complete a washout period from day 2 to day 14 during which no study drugs will be ingested.~     On day 14, subjects will ingest either the reference or test formulation (opposite of the~     formulation received on Study Day 1). All subjects will undergo another 12-hour intensive~     pharmacokinetic evaluation. On days 16 and 17 subjects will provide an additional~     pharmacokinetic sample 24 and 48 hours post dose, respectively. Adverse events and~     concomitant medications will be documented throughout the study.~      The sample size is 16 and is based upon a 10% drop-out rate (i.e. due to lost to follow-up,~     treatment discontinuation, etc.). Since the investigators are expecting two subjects not to~     complete the study, the investigators expect 14 evaluable subjects. If the discontinuation~     rate is greater than 10%, the investigators will continue to enroll until the investigators~     get 14 evaluable subjects. The primary endpoint is to determine average bioequivalence for~     test and reference formulations of tenofovir, emtricitabine and efavirenz according to the~     FDA guidance on bioequivalence testing. The ratio of the test to reference formulation mean~     Cmax and AUC24 for each drug and the 90% confidence interval around each mean ratio will be~     determined. Average bioequivalence will be met if 90% confidence intervals around the Cmax,~     and AUC24 mean ratios for each drug falls within the FDA's predefined limits of 0.80 to 1.25.~   "
206168|NCT00862810|"~     To determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types~     6, 11, 16, and 18) vaccine in 9-18 year old girls elicits an equivalent immune response~     (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd~     dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing~     schedule. This is a prospective observational study of healthy 9-18 year old female patients~     receiving either a second or third dose of HPV vaccine as part of their well child care.~     Immune responses to HPV types 6, 11, 16 and 18 will be measured both before and 1 month after~     the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV~     vaccine when administered at naturally occurring longer dosing intervals to the immune~     response to HPV vaccine when administered as routinely recommended.~      Girls receiving a 3rd dose of HPV vaccine in addition to concomitantly administered vaccines~     by injection were randomized to receive either the HPV vaccine first or their concomitantly~     administered vaccines first. Pain following vaccination was assessed in each arm using the~     Faces Pain Scale - Revised.~      Please note: This record refers only to the randomized portion of the study where pain~     following vaccination was assessed. Please refer to NCT02280642 for the observational portion~     of the study.~   "
206169|NCT00862797|"~     Leakage of fluid from the subglottic space to the lungs occurs along the longitudinal folds~     within the wall of endotracheal tube (ETT) cuffs. In this project the researchers investigate~     the possible effect of swallowing on the pressure course in the ETT cuff.~   "
206170|NCT00862784|"~     The purpose of this study is to test how long participants with colorectal cancer live~     without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified~     FOLFOX-6 chemotherapy.~   "
206171|NCT00862758|"~     Application for Compassionate Use of Tocilizumab in a Boy with Severe Polyarticular Juvenile~     Idiopathic Arthritis (JIA) Unresponsive to All Licensed Medications.~   "
206172|NCT00862745|"~     Six hundred and thirty-six women diagnosed with urge urinary incontinence (UUI) by a~     three-item self-administered questionnaire (3IQ) will be randomized to 12 weeks of~     fesoterodine or matching placebo. The study will take place at up to 14 clinical sites in the~     US. All participants who complete the 12-week randomized trial will be offered open-label~     fesoterodine for an additional 9 months.~      The hypothesis of the randomized controlled trial is that among women diagnosed with urge~     incontinence using the 3IQ, fesoterodine is more effective than placebo in reducing the mean~     number of urge incontinence episodes per day.~   "
206173|NCT00862732|"~     The purpose of the study is to test whether cognitive behaviour therapy (CBT) offered by~     trained therapists, to people with current active suicidal ideations, is efficacious as a~     secondary prevention strategy in Sri Lanka, when compared with treatment as usual provided by~     Medical Officers (Mental Health; MO (MH)) of government hospitals~   "
206174|NCT00862719|"~     The main purpose of this trial is to study whether the drug sitagliptin can be given safely~     to patients undergoing umbilical cord blood transplantation to speed up engraftment (recovery~     of blood counts after transplant).~   "
206175|NCT00862706|"~     The purpose of this study is to investigate the efficacy of telbivudine in Blacks/African~     Americans and Hispanics/Latinos with compensated chronic hepatitis B during 52 weeks of~     treatment~   "
206176|NCT00862693|"~     Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world.~     Much literature suggests that vitamin D and its analogs have profound effects on immune~     system function and glomerular mesangial cell proliferation. Therefore, the investigators~     plan to conduct a randomized clinical study to evaluate the efficacy of Calcitriol in the~     treatment of IgA nephropathy. Forty patients with biopsy-proven IgA nephropathy will be~     recruited. They will be randomized to Calcitriol for six months or no treatment. Proteinuria,~     renal function, serum and urinary inflammatory markers will be monitored. This study will~     explore the potential anti-proteinuric and anti-inflammatory effects of Calcitriol in the~     treatment of IgA nephropathy, which has no specific treatment at present.~   "
206177|NCT00862680|"~     The goal of this clinical research study is to learn if adjusting the PET/CT scanner to allow~     for breathing motion can improve the quality of PET/CT images.~   "
206178|NCT00862667|"~     The purpose of this study is to investigate the time course of PF-00241939 concentration in~     the blood following dosing by oral inhalation from dry powder inhalers.~   "
206179|NCT00862654|"~     The objective is to assess different treatment regimens with Clobetasol propionate shampoo~     0.05% in the treatment of scalp Seborrheic Dermatitis.~   "
206180|NCT00862641|"~     This study is intended to determine the safety and tolerance of regadenoson in subjects with~     asthma or chronic obstructive pulmonary disease.~   "
206181|NCT00862628|"~     The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced~     small-intestinal injuries.~   "
206182|NCT00862615|"~     This project aims to assess the impact of chronic micro-inflammation on age-related loss of~     muscle (sarcopenia) and bone (osteopenia). The hypothesis is that chronic micro-inflammation~     and oxidative stress, which prevalence increases during ageing, may participate in the~     pathogenesis of both sarcopenia and osteopenia.~   "
206205|NCT00862316|"~     The purpose of this study is to determine whether a computer navigational unit can improve~     operating time and consistency during Knee arthroplasty when compared to knee arthroplasty~     without a computer navigational unit.~   "
206184|NCT00862589|"~     The incretin hormone glucagon-like peptide-1 (GLP-1) has known insulinotrophic and~     glucagonostatic properties. However, inpatients with type 2 diabetes mellitus (T2DM)it is~     shown, that the beta cell sensitivity towards GLP-1 is decreased, when comparing to healthy~     controls. Further, these patients have decreased GLP-1 response to a meal.~      The aim of this study is to elucidate if the diabetic hyperglucagonemia, seen in these~     patients both during fasting and in a postprandial condition, is coursed by a decreased~     sensitivity to GLP-1 in the diabetic alpha cell.~      Ten T2DM patients and ten matched healthy control subjects will be examined on two separate~     days. Day 1: increasing GLP-1 infusions and Day 2: saline. During both days plasma glucose~     (PG) will be clamped at fasting level (FPG).~      Patients with T2DM will be submitted til a Day 3, here PG will be normalized over-night by an~     adjustable insulin infusion, on the following day the GLP-1 infusion of Day 1 will be~     repeated.~      The hypothesis is that these patients have decreased alpha cell sensitivity to GLP-1 as is~     the case with the beta cell sensitivity. This decreased sensitivity, the investigators~     speculate, contributes the defect suppression og glucagon and thereby to the increased PG~     levels seen in T2DM. Further the investigators will elucidate if this sensitivity can be~     increased by normalizing the diabetic PG to a normal FPG level.~   "
206185|NCT00862576|"~     This is a case control study of the association between burning mouth syndrome and sleep~     dysfunction. Cases will comprise of patients diagnosed with burning mouth syndrome at the~     UCSF oral medicine clinic. Controls will include patients with leukoplakia, pigmented~     lesions, traumatic lesions, benign tumors, mucoceles, and pemphigoid matched on age (5 years)~     and gender to the cases. New patients as well as those presenting for follow-up visits will~     be eligible.~      Each case and control subject will be administered the following 4 questionnaires by~     interview: (1) enrollment questionnaire (2) Sleep scale from the medical outcomes study~     (MOS), (3) current sleep status scale and (4) a numerical rating scale for measurement of~     oral symptoms.~      Cases (BMS patients) will be followed in the clinic or by telephone contact once per month~     for the following 6 months and questionnaires 1 (question 6 only), 2, 3 and 4 will be~     administered by interview.~   "
206186|NCT00862563|"~     This is a double-blind, placebo-controlled, parallel group design study with 4 treatment~     groups; levetiracetam, zonisamide, topiramate, and placebo control. Subjects will receive~     study medications for 14 weeks. Potential subjects will be initially screened for interest in~     study participation and alcohol consumption level to determine basic eligibility by~     telephone, or in person. Individuals who meet telephone screening criteria will be scheduled~     for a clinic appointment to obtain informed consent and conduct screening assessments.~     Subjects who report average drinks per day that are within the guidelines for safe levels of~     alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) in the two~     weeks prior to screening will be excluded. Subjects meeting screening criteria will be~     scheduled for a second randomization visit. During this visit baseline assessments will be~     obtained. Eligible subjects will then be randomized to a treatment group and will be provided~     with the first week's study medications. The goal is to directly compare the efficacy and~     tolerability of two novel anticonvulsants, zonisamide and levetiracetam, with placebo, and~     using topiramate, which has extensive evidence supporting its efficacy in alcoholism, as a~     positive control group. We believe that this will be the first direct comparison of these~     agents in alcoholism, and the results will provide information on the efficacy and safety of~     the medications.~   "
206187|NCT00862550|"~     PRIMARY AIM~        1. Determine the feasibility of providing true and sham acupuncture treatment to patients~          at Fudan University Cancer Hospital (Cancer Hospital) who are receiving radiation~          treatment for cancer of the head and/or neck area.~           SECONDARY AIMS~        2. Determine if true acupuncture is more effective than sham acupuncture for preventing~          radiation-induced xerostomia among cancer patients at Cancer Hospital.~        3. Determine if true acupuncture is more effective than sham acupuncture for reducing the~          severity of radiation-induced xerostomia.~   "
206188|NCT00862537|"~     An extension study for subjects with prior participation in previous resonator studies using~     low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.~   "
206189|NCT00862524|"~     This is a 2-phase study during which patients with advanced/metastatic solid tumors will~     receive investigational study drug ARRY-334543 and gemcitabine.~      The study has 2 parts. In the first part of the study, Phase 1, patients with~     advanced/metastatic solid tumors will receive increasing doses of study drug in combination~     with gemcitabine in order to achieve the highest dose of study drug possible that will not~     cause unacceptable side effects. Patients will be followed to see what side effects the~     combination causes and what effectiveness the combination has, if any, in treating the~     cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed).~      In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will~     receive the best dose of study drug, in combination with gemcitabine, determined from the~     first part of the study and will be followed to see what side effects the combination causes~     and what effectiveness the combination has, if any, in treating the cancer. Approximately 42~     patients from the US will be enrolled in Part 2 (Withdrawn).~   "
206190|NCT00862511|"~     All metal implants release metal ions because of corrosion. Total knee arthroplasty implants~     have large metal surface areas and therefore substantial potential for corrosion. It is~     planned to compare changes in serum levels of metal ions in patients after implantation of~     cemented unconstrained total knee arthroplasty covered with or without a passivating surface.~     Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared~     between the two groups, as well as with those of 130 control patients without implants.~   "
206191|NCT00862498|"~     This study will test the effectiveness of writing about a traumatic incident to treat~     post-traumatic stress disorder in people who have been in car accidents.~   "
206192|NCT00862485|"~     The purpose of this study is to study MCA Doppler before and after exchange transfusion in~     newborns.~   "
206193|NCT00862472|"~     The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS,~     dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the~     morning.~   "
206206|NCT00862303|"~     The purpose of this study is to show if vaccination with autologous dendritic cells pulsed~     with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a~     measurable immune response in patients with renal cell carcinoma, and to evaluate the~     clinical effect of the regimen.~   "
206194|NCT00862459|"~     The purpose of this study is to look at the safety (what are the side effects) and efficacy~     (how well does it work) of Gadavist when used for taking images of the brain and spine. The~     results of the MRI with Gadavist Injection will be compared to the results of MR images taken~     without contrast and with the results of the MR images taken with OptiMARK.~   "
206195|NCT00862446|"~     Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a~     long period of time frequently develop liver damage. The fat used is called intralipid and is~     made from soybean oil. There is a suggestion in the literature that using fishoil based fats~     called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer~     babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver~     damage reverses.~   "
206196|NCT00862433|"~     Background:~        -  Vitamin E is an antioxidant that reduces the damaging effects of oxygen in the body.~          Most American men (90%) and women (96%) do not get enough vitamin E from their diets;~          however, the amount of vitamin E needed by the body has been studied only in men, not~          women. In addition, it is unknown whether another antioxidant, vitamin C, helps vitamin~          E in protecting the body. Because vitamin E is a fat-soluble vitamin, how much body fat~          a person has could affect the amount of vitamin E needed for protection.~      Objectives: This study has three arms to examine vitamin E requirements:~        -  To determine the amount of fat required to get the best vitamin E absorption from a~          meal.~        -  To determine the amount (i.e., best dose) of vitamin E that must be consumed before it~          can be measured in the blood.~        -  To examine how vitamin E and vitamin C work together in the body, in conjunction with~          diet and vitamin supplements.~      Eligibility:~        -  Arms 1 and 2: Women between the ages of 18 and 40 years who have a normal weight and~          body mass index (BMI) of 27 or less.~        -  Arm 3: Women between the ages of 18 and 40 years who have a normal weight (BMI 27), who~          are overweight (BMI > 27), or who are overweight (BMI > 27) and have non~          insulin-dependent diabetes.~      Design:~        -  Arm 1: Five studies, each lasting 1 month with 1 month off between studies (total study~          = 10 months). Participants will take 500 1,000 mg of vitamin C twice daily for 2 weeks~          before admission to the clinical center for 1 week.~        -  Study 1: Participants will eat breakfast containing a known amount of fat, after which~          they will take a vitamin E pill as well as receive an IV injection of vitamin E. Other~          foods contain only negligible amounts of vitamin E. Blood and urine samples will measure~          levels of vitamin E and other substances.~        -  Studies 2 5: Outpatient visits will consist of the same tests as in Study 1; however,~          the amount of fat in the breakfast will range from 0% to 40% in random order. During one~          of the studies, an adipose tissue biopsy will be collected to determine how much vitamin~          E is in the tissues.~        -  Arm 2: Five studies, each lasting 1 month with 1 month off between studies (total study~          = 10 months). Preparation for Arm 2 is the same as in Arm 1. The proportion of fat,~          muscle, and water in the body will also be measured.~        -  Study 1: Participants will eat breakfast containing 30% fat, after which they will take~          a vitamin E pill as well as receive an IV injection of vitamin E. Conditions and~          procedures are the same as in Arm 1.~        -  Studies 2 5: Outpatient visits will consist of the same tests as in Study 1; however,~          the amount of vitamin E in the breakfast will range from 2 to 30 mg in random order.~        -  Arm 3: Outpatient (2 to 6 weeks) and inpatient studies (4 to 6 weeks).~        -  Outpatient study: Participants will take 500 1,000 mg of vitamin C daily and provide~          blood and urine samples, as well as an adipose tissue sample.~        -  Inpatient studies: Two vitamin E inpatient studies. Before these begin, participants~          vitamin C blood levels will be reduced by means of a diet low in vitamin C. Blood tests~          will determine how quickly vitamin C leaves the body. Once the vitamin C level is~          reduced, the first vitamin E study will begin.~      Study A: The procedure for this study is the same as in Arm 2, Study 1.~      Study B: The procedure for this study is the same as in Study A, except that the participants~     blood vitamin C levels will be higher.~   "
206197|NCT00862420|"~     Primary objective:~        -  To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower~          risk of the safety events of interests in patients with peripheral arterial disease~          (PAD)~      Secondary objectives:~        -  To compare the risk of bleeding adverse events, serious adverse events and overall~          safety of clopidogrel with ticlopidine~        -  To compare the risk of vascular events of clopidogrel with ticlopidine~        -  To document the long-term safety of clopidogrel for a total of 52 weeks~        -  To document the vascular events of clopidogrel for a total of 52 weeks~   "
206198|NCT00862407|"~     This research study is about the effect heart-lung bypass procedures have on the vital organs~     (brain, heart, lungs, and kidneys) during open-heart surgery in pediatric patients. There are~     two types of heart pumps used in surgery requiring heart-lung bypass; one pumps the blood~     continuously through the body and the other pumps the blood with repeated pulses. Both pumps~     are approved for clinical use by the FDA. Although 90% of institutions still use~     non-pulsatile flow, some studies show there may be benefits to using pulsatile flow during~     surgery.~      The investigators want to learn whether the vital organs (brain, heart, lungs, and kidneys)~     respond differently to one method than they do to the other. Approximately 300 children will~     take part in this research at the Hershey Medical Center.~   "
206199|NCT00862394|"~     To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate~     100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the~     corresponding dose of CHF 1535 via HFA-134a extrafine pMDI in terms of pulmonary function~     in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with~     inhaled corticosteroids~   "
206200|NCT00862381|"~     the objective of the study is to assess the value of substitution with 200mg/24h of~     hydrocortisone for 48 hours for patients in intensive care who have received a single~     injection of etomidate~   "
206201|NCT00862368|"~     Parents of Asthmatics Quit Smoking (PAQS-2) is a randomized controlled trial of a smoking~     cessation intervention for parents who smoke. Children had either a diagnosis of asthma (and~     an asthma emergency within the past 3 months) or were healthy (and had no medical conditions~     in the past 3 months). The study intervention aimed to help parents (or caregivers) quit~     smoking and reduce children's second hand smoke exposure. Participants received 2 home~     counseling sessions with asthma education (if they had a child with asthma), child wellness~     (if they had a healthy child) and smoking cessation counseling (including objective feedback~     on how much smoke the child was exposed to). Parents of children with asthma were then~     randomized into 2 groups; one group received 6 counseling phone calls focused on motivating~     smoking cessation and a second round of feedback on smoke exposure (Enhanced). The other~     groups received six calls focused on asthma (PAM asthma group) or child wellness (Healthy~     group). We had 2 primary aims. First, to explore the teachable moment we compared quit~     rates between the parents of children with asthma to the parents of healthy children. We~     hypothesized that the Asthma group would have significantly greater quit rates than the~     Healthy group and lower levels of environmental tobacco smoke in the home. We also~     hypothesized that parents who smoke and have children with asthma would have greater changes~     in the variables associated with teachable moment compared to parents who smoke and have a~     healthy child. --- The second primary aim focused on the parents of children with asthma. We~     assessed the effectiveness of adding telephone smoking cessation counseling to the 2 home~     counseling visits. For this, we compared the 2 groups of randomized subjects: those who~     received 6 counseling calls and feedback on smoke exposure (PAM-Enhanced) and those who~     received 6 counseling calls focused on asthma education (PAM-Asthma). We hypothesized that~     the PAM-Enhanced group would have significantly greater quit rates than the PAM-Asthma group,~     lower likelihood of smoking relapse, and lower levels of environmental tobacco smoke in the~     home. We also explored the hypothesized role of precaution effectiveness (i.e. quitting~     smoking will be associated with benefits for self and child) and self-efficacy for quitting~     as mediators of the effectiveness of PAM-Enhanced/Asthma. A third aim was to compare asthma~     symptoms over time between the two groups.~   "
206202|NCT00862355|"~     Bioequivalence study of SPARC147609~   "
206203|NCT00862342|"~     Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE)~     and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first~     line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At~     median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st~     PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received~     BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any~     2nd-line chemotherapy were independently associated with increased overall survival (both p <~     0.0001). Bevacizumab beyond progression appears to be associated with longer overall in~     BRiTE.~      The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond~     progression.~   "
206204|NCT00862329|"~     Dietary protein is the more satiating nutrient, however it is not clear whether satiety may~     be influenced by the nature of the protein. This study was designed to assess potential~     differences between protein sources on satiety and their relationship with digestive and~     metabolic kinetics.~   "
206207|NCT00862290|"~     MicroRNA has been demonstrated to play a crucial role in regulating cell processes. Recently,~     microRNA was identified to exist in human serum or plasma, and it might be related to certain~     diseases. Several microRNAs are involved in sepsis, such as miR-146, miR-155, and so on. But~     whether serum miR-146 is present in serum of septic patients remains unknown. The present~     study was designed to identify the existence of specific microRNAs, which might be new~     markers for sepsis and its prognosis.~   "
206208|NCT00862277|"~     To evaluate the persistence of bactericidal antibodies in adolescents and adults who received~     one dose of Menactra® vaccine approximately four to eight years earlier~   "
206209|NCT00862264|"~     Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in~     patients with mild to moderate persistent asthma.~   "
206210|NCT00862251|"~     The purpose of this study is to determine the efficacy of switching to a combination tablet~     ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose~     in those patients who have cardiovascular disease and diabetes mellitus not adequately~     controlled on simvastatin 20 mg or atorvastatin 10 mg.~   "
206211|NCT00862238|"~     In the study, homeless youth from a drop-in site and faculty from UCLA and California~     Institute of the Arts will develop, pilot test and evaluate a youth-based drug and~     health-promoting program. It is hoped that this program will help in the development of a~     program that can be further tested in a larger study and lead to the development of an~     innovative and effective drug counseling program that youth situated in homeless sites will~     utilize.~   "
206212|NCT00862225|"~     Randomised, double-blind and prospective clinical study to examine the mechanism of action of~     the Petasites hybridus leaf extract IG-RD-001 (Ze-339, petasol butenoate complex) compared to~     desloratadine and placebo in patients with seasonal allergic rhinitis of all degrees of~     severity (provoked by grasses). The treatment arm with desloratadine is an established~     standard treatment and is intended to ensure the comparative methodology of the study.~   "
206213|NCT00862212|"~     The purpose of this study is to treat individuals with social anxiety disorder with a Food~     and Drug Administration-approved medication for the treatment of social anxiety disorder, the~     antidepressant paroxetine, and to evaluate the impact of an intervention designed to help~     those individuals cope with anxiety without the use of common coping behaviors.~   "
206214|NCT00862186|"~     This study will investigate self-management of cancer-related fatigue by adolescents through~     pilot study of an evidence based educational resource.~   "
206215|NCT00862173|"~     Non small-cell lung cancer (NSCLC) accounts 85% of all lung cancer.The development of brain~     metastasis diminished life expectancy to less than one year with a median survival of less~     than three months. In NSCLC cancer, approximately 50% of patients with locally advanced~     disease develop brain metastasis at some time during the natural of disease. The central~     nervous system constitutes the first site of recurrence in 15 to 40% of these patients.~     Microarrays evaluate the diagnosis, treatment and prognosis of lung cancer.There are no~     studies that specifically evaluate the relationship between a genetic profile of NSCLC and~     metastasis to the CNS, with the purpose of distinguishing a subgroup of patients that will~     benefit of prophylactic treatment.What is the association between a genetic profile on NSCLC~     and the development of CNS metastasis.Obtaining a genetic profile from the primary NSCLC~     tumor cells, by using microarrays, we can predict the development of CNS metastasis arise a~     subgroup of patients that could benefit from prophylactic cranial radiation with which their~     quality of life and prognosis most probably will increase.Objective:Determine the association~     between a genetic profile from the primary tumor cells and the development of central nervous~     system metastasis in patients with non small-cell lung cancer.A genetic profile from the~     primary tumor cells are associated with the development of central nervous system metastasis~     in patients with NSCLC. A clinical, prospective, analytic, open, non randomized, prognostic~     and observational cohort with 66 patients with NSCLC who authorize a biopsy study from~     February, 2008 to December, 2012, INMEGEN institute will be in charge of performing the~     microarrays and the computer analysis in order to obtain the different genetic profiles that~     will be differentially expressed related with CNS metastasis risk profiles. Patients will be~     followed-up by means of the external consult of lung neoplasms. The statistical analysis will~     be performed using tests like Student's t or Mann-Whitney's U test. A multivariate analysis~     of logistic regression will be performed. Global survival time will be analyzed using~     Kaplan-Meier's technique and the comparison between groups will be performed with log-rank~     test. The adjustment for potential confusors will be performed using multivariate regression~     analysis. For result representation, we will use tables and graphs and pertinent measures~     will be taken to disclose the study.~   "
206216|NCT00862160|"~     The prospective, randomized, two centre study investigates acute cerebrovascular events~     during extracorporal circulation and the early post operative outcome when using either the~     minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass~     circuit in patients undergoing coronary artery bypass grafting.~   "
206217|NCT00862147|"~     The objective of this study is to evaluate the effect of the International Child Development~     Program (ICDP). Research questions to be answered:~        1. Does the ICDP affect children's psychosocial functioning compared to treatment as usual?~        2. Does the ICDP change parent-child interaction?~   "
206218|NCT00862134|"~     The current understanding of PR104 justifies the evaluation of PR104 with docetaxel in~     subjects with Non Small Cell Lung Cancer (NSCLC). These include:~        -  Aldo-keto reductase 1C3 (AKR1C3). NSCLC has been shown to express high levels of AKR1C3~          in about one half of tumors tested. Subjects with high levels of AKR1C3 should have~          increased activation of PR104 within their tumor.~        -  Hypoxia. NSCLC has been demonstrated to be a tumor with hypoxia based on both direct~          tumor measurements (oxygen electrodes) and hypoxic positron emission tomography (PET)~          imaging. Tumor hypoxia in NSCLC should be sufficient to activate PR104 to its active~          metabolites PR104H and PR104M.~        -  Preclinical data. The use of docetaxel and PR104 alone and in combination in preclinical~          models demonstrates activity of PR104 as a single agent and supraadditive activity when~          PR104 and docetaxel are used in combination.~        -  Manageable toxicity. PR104 and docetaxel with Granulocyte Colony-stimulating Factor~          (G-CSF) have been combined in a prior phase I study. A Maximum Tolerated Dose (MTD) has~          been identified and the major toxicities of this combination are understood.~      The current study will provide an estimate of the activity of PR104 in subjects with NSCLC.~     This information will prove valuable in defining the future clinical development of PR104,~     and in determining if PR104 has sufficient activity in NSCLC to warrant a larger phase III~     registration study in this indication.~      Primary objectives~      • Estimate the response rate (RR) of PR104/docetaxel~      Secondary objectives~        -  Evaluate survival~        -  Evaluate progression free survival (PFS)~        -  Evaluate time to progression (TTP)~        -  Evaluate safety~        -  Evaluate the pharmacokinetics of PR104 and its metabolites~        -  Evaluate the pharmacokinetics of docetaxel~        -  Evaluate the tumor hypoxia using 18F-fluoromisonidazole (18F-MISO) PET imaging~        -  Collect diagnostic biopsy samples for the determination of AKR1C3~        -  Collect plasma samples for assessment of potential biomarkers of tumor hypoxia~   "
206219|NCT00862121|"~     The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose~     and a 4 g evening dose is efficacious in active mild to moderate CD.~   "
206220|NCT00862108|"~     The purpose of this study is to determine whether norepinephrine gene polymorphism affect to~     treatment response in ADHD~   "
206221|NCT00862095|"~     To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in~     patients with chronic post-traumatic headaches.~   "
206305|NCT00860977|"~     This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of~     twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for~     initiating HAART among HIV infected individuals who neither use nor require HAART, and who~     have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study~     initiation.~   "
206222|NCT00862082|"~     The current understanding of PR104 justifies the evaluation of PR104 with sorafenib in~     patients with hepatocellular carcinoma. These include:~        -  Hypoxia. Hepatocellular Carcinoma (HCC) is likely to demonstrate a level of hypoxia~          sufficient to activate PR104 to its active metabolites PR104H and PR104M. In addition,~          in preclinical models, sorafenib has been demonstrated to increase the degree of hypoxia~          in tumors following treatment.~        -  Non-overlapping toxicity. PR104 and sorafenib do not share major toxicities. It is~          anticipated that both drugs can be administered at their full single agent dose when~          used in combination.~        -  Aldo-keto reductase 1C3 (AKR1C3). HCC has been shown to express high levels of AKR1C3~          which should lead to selective activation of PR104 within both hypoxic and oxic HCC~          cells.~        -  Preclinical data. The use of sorafenib and PR104 alone and in combination in a~          hepatocellular carcinoma model demonstrates activity of PR104 as a single agent and~          increased activity when PR104 and sorafenib are used in combination.~      The current study will provide an estimate of the activity of PR104 in subjects with HCC.~     This information will prove valuable in defining the future clinical development of PR104,~     and in determining if PR104 has sufficient activity in HCC to warrant a larger phase III~     registration study in this indication.~      Primary objectives~        -  Phase I: Determine the maximum tolerated dose (MTD) of PR104 when used in combination~          with standard dose sorafenib~        -  Phase II: Estimate the response rate (RR) of PR104/sorafenib [Note: Phase II was never~          initiated]~      Secondary objectives~        -  Evaluate survival~        -  Evaluate Progression Free Survival (PFS)~        -  Evaluate time to progression (TTP)~        -  Evaluate safety~        -  Evaluate the pharmacokinetics (PK) of sorafenib, PR104 and PR104 metabolites~        -  Collect diagnostic biopsy samples for the determination of aldo-keto reductase 1C3~        -  Collect plasma samples for assessment of potential biomarkers of tumor hypoxia~   "
206223|NCT00862056|"~     This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in~     patients who have not been diagnosed with atherosclerosis and who have no symptoms of the~     disease but who are at risk of developing atherosclerosis based on traditional risk factors~     such as diabetes or a family history of coronary artery disease.~   "
206224|NCT00862043|"~     The purpose of this study is to evaluate the clinical efficacy of the mid-term treatment with~     sildenafil in patients with persistent moderate or severe pulmonary hypertension (PH) after a~     heart valve intervention.~   "
206225|NCT00862030|"~     Radiotherapy (RT) treatment to the chest is a standard way of trying to decrease symptoms~     like cough or shortness of breath. Before any RT can be delivered, it must be planned, either~     using conventional x-rays (fluoroscopy) or using computer tomography (CT) scanning. This~     study is being done because the investigators do not know which of these two common ways of~     RT planning is better for balancing both treating the cancer and decreasing side effects.~   "
206226|NCT00862017|"~     There are receptors to free glutamate in the oral cavity and stomach that may mediate effects~     of this amino acid on gastrointestinal physiology. The investigators hypothesize that a~     chronic supplementation of monosodium glutamate (MSG) could modulate gastric emptying and the~     further metabolism of dietary protein in healthy subjects.~   "
206227|NCT00862004|"~     The purpose of this study is to examine the feasibility of video-assisted thoracoscopic~     surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical~     stage IIIA non-small cell lung cancer. Success is defined as VATS major pulmonary resection~     with SND without conversion. If success rate over 90%, VATS major pulmonary resection with~     SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer.~   "
206228|NCT00861991|"~     Background: Empathy is critical to clinician-patient communication and patient outcomes.~     Perspective-taking, an intervention demonstrated in other contexts to induce empathy, has~     never been studied in a medical context. As a first step in evaluating its potential clinical~     value, the studies described below assess perspective taking in a series of clinical skills~     examinations. These examinations are simulated clinical encounters: students encounter and~     are evaluated by standardized patients (SPs)--actors trained to take on patient roles. Though~     not real clinical encounters, clinical skills examinations have been demonstrated to test~     clinical competency well enough to be incorporated into the licensure examination of the~     National Board of Medical Examiners.~      Objective: To assess if perspective-taking improves the satisfaction of standardized patients~     in three clinical skills examinations.~      Hypothesis: Students receiving a perspective taking intervention will receive better~     standardized patient satisfaction scores than control students.~      Design and Setting: Three randomized, controlled studies. Studies 1 and 3: Junior medical~     students(N = 503), 6-station clinical skills examination. Study 2: physician assistant~     students (N = 105), 3-station clinical skills examination.~      Intervention: The intervention students received a perspective-taking instruction prior to~     their examination asking them to put themselves in their patients shoes and to imagine what~     they were thinking and feeling. The control students received standard pre-examination~     instructions. Simulated patients were blind to study condition. Main Outcome Measure:~     Simulated patient satisfaction scores.~   "
206229|NCT00861978|"~     The aim of tis study is to assess the efficacy and safety of Jarsin® 300 mg as an acute~     treatment in mild to moderate depression with atypical features.~   "
206230|NCT00861965|"~     This phase I/II clinical investigation is designed to determine the safety and anti-tumor~     effects of intravenous administration of the experimental immunotherapy drug, called~     AlloStim. The active ingredient of AlloStim is living, human immune cells that have been~     differentiated and expanded outside the body. Because AlloStim does not require HLA match, it~     is being evaluated as an alternative to allogeneic bone marrow/stem cell transplantation.~   "
206231|NCT00861952|"~     The purpose of this study is to determine if the use of Neuragen (a natural health product~     oil rubbed into the skin) is effective at reducing pain and improving the quality of life in~     people with diabetic peripheral neuropathy.~   "
206232|NCT00861939|"~     The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 300~     mg ER Tablets under fasting conditions.~   "
206233|NCT00861926|"~     Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study~   "
206234|NCT00861913|"~     This phase II trial is studying the side effects of pazopanib hydrochloride and to see how~     well it works in treating patients with metastatic melanoma that cannot be removed by~     surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
206235|NCT00861900|"~     The investigators have obtained compelling evidence that the development of anti-human~     leukocyte antigen (anti-HLA) antibodies against mismatched donor antigens significantly~     correlates with the development of bronchiolitis obliterans (BOS). Further, these anti-HLA~     antibodies are developed at least 15 months prior to any clinical evidence of BOS. This lag~     period between the development of anti-HLA antibodies and the onset of BOS gives us an~     opportunity to intervene to delay and/or prevent the development of BOS.~   "
206306|NCT00860964|"~     The purpose of this trial is to study the efficacy and safety of low dose of estradiol~     valerate in the prevention and treatment of postmenopausal osteoporosis.~   "
206236|NCT00861887|"~     BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel,~     usually associated with previous use of antibiotics. The disease course may be complicated by~     fulminant disease requiring removal of the colon or by multiple recurrences requiring~     re-hospitalization. The incidence and severity of Clostridium difficile infection is rising,~     and it poses an increasing burden on the health system. For example, in one of our previous~     studies we found that 804 in-patients and 568 out-patients had a positive test for~     Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2~     week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears to~     be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment. The~     recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is~     usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50%~     during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week~     duration of treatment might not be adequate in clearing the infection.~      Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will~     lead to a decrease rate of recurrent Clostridium Difficile colitis.~   "
206237|NCT00861874|"~     The purpose of this study is to determine the safety and feasibility of the combination of~     decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed~     or refractory acute myeloid leukemia.~   "
206238|NCT00861861|"~     The purpose of this study is to compare the effects of pitavastatin and atorvastatin on~     adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.~   "
206239|NCT00861848|"~     The present study is designed to:~        1. investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in~          adolescents and adults ages 13-40 with congenital and acquired congenital heart disease~        2. compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow~          reserve and ventricular wall motion~        3. assess regional myocardial mechanics using myocardial speckle tracking and MR tagging.~   "
206240|NCT00861835|"~     Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB)~     transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid~     on-site evaluation by cytopathology (ROSE) but were limited by lack of randomization. The~     investigators performed the first randomized-prospective trial comparing ROSE(R) to no~     on-site cytopathology assessment (NR).~      Methods: All patients referred were eligible. 78 patients were randomized to R or NR groups.~     For R procedures, further specimens were deferred until results were available from the~     on-site cytopathologist. Diagnoses made by all procedures were recorded. The primary~     end-points were specimen adequacy and diagnostic yield.~   "
206241|NCT00861822|"~     One of the major complications of heart surgery is kidney injury, which occurs in up to 30%~     of patients and is associated with poor outcomes including death. We have found that patients~     whose hemoglobin concentration before surgery is lower than normal (i.e., are anemic) are at~     particularly high risk for this complication, likely because their hemoglobin concentration~     drops to very low levels during surgery, which reduces delivery of oxygen to the kidneys,~     increases blood loss, and necessitates blood transfusions. We and others have shown that~     these events are individually harmful to the kidneys, and can lead to kidney injury. We~     believe that we can prevent these events from occurring, and as a result reduce the risk of~     kidney injury, if we transfuse anemic patients at least 1 day before surgery rather than~     during surgery.~      In anemic patients undergoing cardiac surgery, prophylactic transfusion of red blood cells~     (RBCs) before surgery will reduce the risk of acute kidney injury (AKI) after surgery by~     mitigating three inter-related risk factors for AKI.~   "
206242|NCT00861809|"~     The purpose of this study is to assess the pharmacodynamic effects (gastric emptying),~     safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic~     patients with gastroparesis.~   "
206243|NCT00861796|"~     This Phase II study will test whether CYR-101, a CNS-active compound with novel~     pharmacological profile and devoid of dopamine D2 receptor binding properties, is efficacious~     when administered orally in the management of patients with a diagnosis of DSM-IV~     schizophrenia.~   "
206244|NCT00861783|"~     Studies done in the laboratory have demonstrated beneficial effects of ON 01910.Na, a new,~     unapproved drug, when it is used in combination either irinotecan and oxaliplatin, two~     approved, extensively used anti-cancer drugs. In these laboratory studies, mice implanted~     with cells (Bel-7402 cells) that came from a human tumor were used as a model of liver~     cancer. In mice that were not treated, the Bel-7402 cells formed very large tumors. In mice~     that were treated with ON 01910.Na, irinotecan or oxaliplatin alone, growth of tumors was~     reduced compared to the untreated group. When a combination of ON 01910.Na and irinotecan or~     of ON 01910.Na and oxaliplatin was used to treat the mice, tumor growth was completely~     inhibited. Another observation in these studies was that toxicity did not increase when the~     combinations were used. These results and similar results from other studies support the~     hypothesis that a combination of ON 01910.Na and irinotecan or of ON 01910.Na and oxaliplatin~     would be an effective and tolerable treatment for liver and other types of cancer.~      The primary objective of this phase 1 study is to find out what doses of ON 01910.Na in~     combination with either irinotecan or oxaliplatin are safe and tolerable in patients with~     liver and other types of cancer.~   "
206245|NCT00861770|"~     This will be a clinical test to determine if using blood volume measurements (BVM) to help~     guide fluid removal with ultrafiltration in patients hospitalized with decompensated heart~     failure leads to improved outcomes.~   "
206246|NCT00861757|"~     This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design,~     multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12~     weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).~   "
206247|NCT00861744|"~     The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines~     (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and~     safety with a six month follow-up after first vaccination. Additionally, antibody persistence~     will be assessed one and two years after administration of MMR vaccine.~      The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.~   "
206307|NCT00860951|"~     The purpose of this research is to develop tools enable people who are paralyzed to operate~     technology and access computers. These tools are called brain computer interfaces (BCIs).~     BCIs would let a person use brain signals to operate technology.~   "
206248|NCT00861731|"~     The purpose of this study is to determine whether, in patients with chronic proteinuric~     nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than~     statin alone to achieve the optimum lipid control, and if this translates to an improvement~     of the markers of vascular damage. Thirty hypertensive patients in stable therapy with RAS~     inhibitors, with low-density lipoprotein (LDL) cholesterol superior to 100 mg/ml, are treated~     with three different hypolipidemic regimens: Simvastatin alone (40 mg/day) or~     ezetimibe/simvastatin combined therapy (10/20 or 10/40 mg/day).~   "
206249|NCT00861718|"~     Multiple Ascending Dose Study~   "
206250|NCT00861705|"~     This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or~     bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with~     breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel,~     carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may~     stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy~     together with bevacizumab before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed.~   "
206251|NCT00861692|"~     The purpose of this study is to collect data on the clinical management of Argatroban in~     patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or~     without ongoing thrombosis who require parenteral antithrombotic therapy~   "
206252|NCT00861679|"~     To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the~     HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched~     family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether~     therapy has been carried out according to the main HSCT protocol recommendations. The~     standardisation of the treatment options during HSCT from different donor types aims at the~     achievement of an optimal comparison of survival after HSCT with survival after chemotherapy~     only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after~     HSCT from MSD, from MD and from MMD.~   "
206253|NCT00861666|"~     The purpose of this study is to evaluate a forgiveness-based writing intervention in an open~     trial with 20 Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veterans who have~     recently experienced combat-related trauma to:~        1. Determine the feasibility of delivering the intervention.~        2. Evaluate the acceptability of the intervention.~        3. Collect preliminary outcome data on PTSD symptoms, depression, anxiety, anger, and~          forgiveness.~   "
206254|NCT00861653|"~     The purpose of this study is to utilize high-resolution CMR carotid imaging for the~     characterization of carotid wall volumes and plaque content in patients with clinical~     significant carotid atherosclerosis. Patients who are scheduled to undergo an imaging~     procedure will be recruited from the cath lab. Upon enrollment, blood samples conventional~     and genetic profiling will be collected. For patients undergoing a carotid endarterectomy,~     tissue from the carotid vessel will be collected during their procedure. Comparison of the MR~     images with tissue and/or blood samples will be made. Length of time in the study will be~     approximately 1 day. There will be no study-related patient follow-up.~   "
206255|NCT00861640|"~     Introduction: Proton pump inhibitor (PPI) is the drug of choice used in patients with~     non-variceal upper gastrointestinal tract bleeding (UGIB). Intravenous (IV) PPI is more~     commonly used than oral form when overt bleeding occurs. Previous study has revealed that~     oral rabeprazole and IV omeprazole achieved similar intragastric pH elevation. It's probable~     that oral form and IV PPI provide equal efficacy in treating mild to moderate UGIB patients.~      Aim: This study aims to compare the effect of three-day oral rabeprazole and iv omeprazole on~     bleeding control in patients with mild to moderate non-variceal UGIB.~      Patients and methods: All patients presented with black to tarry stool passage or hematemesis~     and visited our ER will be evaluated to recruit into this study. They will receive regular~     vital sign monitoring, laboratory study and nasogastric tube insertion with gastric fluid~     aspiration. Esophagogastroendoscopy and hemostatic procedure if need will be performed within~     12 hours. Those confirmed to have non-variceal UGIB, stable vital signs and agree to~     participate into this study will be randomized into two groups receiving either oral~     rabeprazole (20mg bid) or iv omeprazole (40mg qd) for three days. The presence of recurrent~     bleeding within three days, in-hospital complication and duration of hospital stay will be~     recorded and analyzed.~      Expected results: At the end of this study, we will be able to determine whether patients~     treated with oral rabeprazole and iv omeprazole have similar re-bleeding or complication~     rates and hospitalization days.~   "
206256|NCT00861627|"~     The purpose of this Phase 2 study is to investigate whether intravenous administration of a~     wild type reovirus (REOLYSIN®) in combination with paclitaxel and carboplatin is effective~     and safe in the treatment of Non-Small Cell Lung Cancer with KRAS or EGFR activation.~   "
206257|NCT00861614|"~     The purpose of the study is to determine if advanced prostate cancer patients that are~     treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone~   "
206258|NCT00861601|"~     This is an open label, multi-centre, dose ranging study to assess efficacy, safety and~     pharmacokinetics of eltrombopag in thrombocytopenic subjects with chronic liver disease.~   "
206272|NCT00861419|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG~     386 when used in combination with AMG 706, bevacizumab, sorafenib, or sunitinib and that at~     least one dose level from each combination will be safe and well tolerated.~      AMG 386 is a man-made medication that is designed to stop the development of blood vessels in~     cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called~     angiogenesis, to obtain a supply of oxygen and nutrients to grow.~   "
206273|NCT00861406|"~     The goal of this clinical research study is to find the best dosing schedule of a combined~     treatment of PEG Intron® (pegylated Interferon-alfa 2b) plus a peptide vaccine (gp100) that~     may help improve immune response in patients that had Stage II or Stage III melanoma and are~     free of the disease. The safety and tolerability of this drug combination will also be~     studied. Researchers also want to collect long-term follow-up information.~   "
206274|NCT00861393|"~     The purpose of the study is to determine whether or not a brief psychological treatment~     called cognitive behaviour therapy will help people who have suffered a spinal cord injury to~     cope better with their current circumstances.~   "
206259|NCT00861588|"~     Benign prostatic hyperplasia (BPH) is a common problem among aging Caucasian men that~     produces significant morbidity and hea1th care costs. It is likely that BPH is just as common~     among Chinese men. Debate exists as to whether currently available surgical and~     pharmacological options for BPH are appropriate for men in the watchful-waiting stage of this~     condition. Evidence suggests that the consumption of soy isoflavones is related to lower~     rates of BPH among Asian men. The advantages of soy isoflavones over conventional therapies~     may include better patient compliance, improved safety and lower cost. Despite the fact that~     soy isoflavones are safe and contain a health-conferring ingredient with a defined mechanism~     of action, no randomised control trial has been performed using isoflavones to treat BPH.~     Therefore, a randomised control trial is proposed to test the tolerability and effectiveness~     of soy isoflavones (Soylife) verses placebo in 182 men with defined watchful waiting BPH over~     a period of 12 months. In this trial, patients who fulfill the inclusion criteria, will~     either be given 40mg of soy isoflavones capsule (once daily) or a placebo capsule. They will~     be reviewed every three months with maximal urine flow rate, international prostate symptoms~     score and quality of life measured. Baseline tests include RFT, LFT, FBC, MSU, PSA and~     testosterone and to be repeated at 6th month and 12th month. The investigators hypothesize~     that this intervention will reduce lower urinary tract symptoms and slow the progression of~     the disease.~   "
206260|NCT00861575|"~     This is a continuous blood banking study that will archive plasma and blood permitting DNA~     and plasma analysis at a future date. Subjects are recruited at the time of a clinically~     required procedure and blood samples are collected and banked and used for future research.~     The main purpose of this study is to investigate the interaction of multiple phenotypes and~     genotypes and their impact on cardiovascular disease events and measures of atherosclerosis~     progression.~   "
206261|NCT00861562|"~     The purpose of this study was to assess the clinical efficacy and safety of the drug Imescard~     water smartweed compound pills in the treatment of patients with chronic constipation and~     hemorrhoidal disease.~   "
206262|NCT00861549|"~     The purpose of this study is to evaluate the bioavailability of two formulations (Taiwan and~     China mainland) of phencynonate hydrochloride tablets and to generate pharmacokinetic and~     safety profiles of phencynonate hydrochloride in healthy volunteers.~   "
206263|NCT00861536|"~     An open, multicenter, randomised, parallel group pilot study to investigate two different~     polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of~     ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients~     following renal transplantation. This non-inferiority trial shall demonstrate that~     ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side~     effects.~   "
206264|NCT00861523|"~     There are different treatments for nausea and vomiting in pregnancy. According to the ACOG~     recommendations, promethazine is the first line of parenteral treatment after oral treatment~     had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find~     out whether thiamine helps the vomiting and nausea as well, by comparing the response to~     thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.~   "
206265|NCT00861510|"~     Background:~        -  Mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM),~          and other lymphoid malignancies are all incurable lymphoid malignancies that mainly~          affect persons in their late 60s and early 70s. Conventional chemotherapy can achieve~          high rates of clinical response, but relapse following these responses is almost~          universal. Patients with lymphoid malignancies relapse because their tumor cells become~          resistant to chemotherapy; therefore, new types of drugs are needed for better treatment~          responses.~        -  The investigational drug ON 01910.Na has been shown to be active against MCL and CLL~          cells, but further research is needed to determine the most safe and effective dose for~          this drug.~      Objectives:~        -  To determine the maximum tolerated dose (the highest dose that does not cause~          unacceptable side effects) of ON 01910.Na in patients with cancers of the lymphoid~          cells.~        -  To study the effects that ON 01910.Na has on cancers of the lymphoid cells.~      Eligibility:~        -  Patients 18 years of age and older who have been diagnosed with cancer of the lymphoid~          cells, and who have not been able to take or have not benefitted from existing treatment~          options.~      Design:~        -  Evaluations before the treatment period:~        -  Full medical history and physical examination, and pregnancy test for women.~        -  Blood and urine tests.~        -  Disease evaluation with computerized tomography (CT) scan, magnetic resonance imaging~          (MRI), electrocardiogram; bone marrow and lymph node biopsies; and skeletal x-rays, if~          clinically indicated.~        -  Treatment with ON 01910.Na:~        -  Different research subjects will receive increasing doses of ON 01910.Na to determine~          which dose is considered safe.~        -  To reduce the risk of one rare serious side effect of treatment for myeloid~          malignancies, patients will take allopurinol 12 hours before and 7 days after each drug~          infusion, one 300 mg pill each day.~        -  Cycles 1 2: Patients will be admitted to the clinical center for 2 days at the beginning~          of each cycle. Each cycle involves intravenous infusion of ON 01910.Na continuously for~          a period of 48 hours, followed by 12 days of observation. Researchers will try to~          maintain the schedule of 2 days of infusion every 14 days, but the interval between~          doses may be extended if patients experience delayed recovery blood counts.~        -  Cycles 3 4: Patients who are doing well and choose to continue may receive an additional~          two cycles (2 days of inpatient infusion followed by 12 days of outpatient observation).~          At the end of cycle 4, researchers will determine if the disease is responding to~          therapy. Patients who experience side effects may continue to take ON 01910.Na at a~          lower dose or may stop receiving the drug.~        -  Patients who respond well to four cycles of ON 01910.Na may be eligible for additional~          cycles of ON 01910.Na.~        -  Patients who need to start another medication to treat their disease will stop taking ON~          01910.Na, and the researchers will perform a final study visit 2 weeks after the last~          dose of ON 01910.Na. After that, participation in the study will be complete.~   "
206266|NCT00861497|"~     The purpose of this study is to provide access to bifeprunox for patients, who have completed~     previous studies with bifeprunox, and require continued treatment with bifeprunox, other~     treatment not being adequate. A further purpose is to investigate the safety and side-effects~     of bifeprunox during long-term treatment.~   "
206267|NCT00861484|"~     The purpose of this study is to determine if the administration of GSK958108 can delay~     ejaculation in patients with primary premature ejaculation as measured by the ejaculatory~     latency time (ELT) using the masturbation model and sexual visual stimulation, and to~     evaluate the safety and tolerability of GSK958108 in healthy men with PE~   "
206268|NCT00861471|"~     This trial is designed to determine the proper doses of Docetaxel and Imatinib mesylate to be~     used to treat hormone refractory prostate cancer and to evaluate the safety and efficacy of~     the treatment.~   "
206269|NCT00861458|"~     This study will test two different formulations. The results will be used to select~     formulation for phase 3.~   "
206270|NCT00861445|"~     The primary purpose is to investigate the safety and efficacy of SPM927 in patients with~     Painful Diabetic Neuropathy~   "
206271|NCT00861432|"~     Tumor patients receiving conventional tumor therapies are included into this study. The~     patients are randomized into two groups receiving either additive homeopathic therapy or not.~     Two questionnaires referring to subjective feeling and life quality are filled out by the~     patients with each visit to the outpatients Department. One of them is the QLQC30~     questionnaire of the EORTC. The results of the questionnaires of the two groups are compared.~   "
206275|NCT00861380|"~     The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal~     conjugate vaccine (GSK1024850A), administered according to different vaccination schedules,~     against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact~     on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and~     outpatient antimicrobial prescriptions.~      This study will also explore vaccine impact on occurrence of respiratory tract infections~     (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.~   "
206276|NCT00861367|"~     Aspirin is very common in older patients. Therefore many of the investigators patients have~     aspirin. The aim of the study is to proof that Transurethral Surgery of the bladder or the~     prostate can be performed with aspirin.~   "
206277|NCT00861354|"~     This study assess the accuracy of a blood pressure monitor designed to detect atrial~     fibrillation. Subjects use the blood pressure monitor on a daily basis for 30 days and~     compare the readings to an ECG done at the same time.~   "
206278|NCT00861341|"~     The purpose of this study is to determine how pioglitazone and aspirin affect platelets in~     the blood of diabetic and non-diabetic subjects. Platelets are small cells in the blood that~     help with blood clotting. Pioglitazone is a drug that is used to lower blood sugar and fats~     by helping the body to use insulin correctly. Pioglitazone is presently used to treat~     diabetes but has not been approved for non-diabetics. This study will determine whether~     pioglitazone reduces the activity of platelets in people who are or are not also taking~     aspirin.~   "
206279|NCT00861328|"~     Treatment of cancer is often improved if two or more drugs are used in combination. In animal~     studies, the use of the combination of ON 01910.Na (a new, unapproved drug) and irinotecan or~     oxaliplatin (two approved and extensively used anti-cancer drugs) gave better results against~     tumor cells than the use of any of the single drugs alone. In addition, the use of the~     combinations did not result in an increase of side effects. This clinical trial will~     determine what is the highest dose of ON 01910.Na that can be given safely in combination~     with either irinotecan or oxaliplatin in human patients.~   "
206280|NCT00861315|"~     Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order~     to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine~     the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close~     to but inferior to those observed after standart intravenous amikacin infusion.~   "
206281|NCT00861302|"~     This interventional study seeks to evaluate the overall outcomes of a novel, emotional~     awareness intervention for people with chronic musculoskeletal pain and determine which~     patients benefit the most from this intervention. The investigators also are evaluating the~     effects of brief emotional communication technique embedded in the pre-treatment assessment.~   "
206282|NCT00861276|"~     Objective: To assess the impact of instructional guidance in the regular use of use nicotine~     nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation~     for heavy smokers who are willing to quit.~      Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers,~     were willing to quit, and attending an academic outpatient clinic in Western Switzerland.~     Patients were randomised to instruction on NNS use as ad libitum (administration whenever~     cravings appear; control group) or to use NNS at least every hour when awake (intervention~     group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM)~     during the first three weeks of use. Self reported abstinence from smoking at six months was~     confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect~     GLS regression was used to calculate the mean difference of daily doses between groups~     controlling for lack of independence between measures from the same individual.~   "
206283|NCT00861263|"~     Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of~     disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI~     tract, which can prove difficult to visualize during an endoscopy specifically designed to~     evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease®~     spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical,~     Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are~     to evaluate the efficiency of an overtube system for visualization of small bowel. The~     hypothesis is that this will permit more complete and efficient evaluation of the small~     intestine.~   "
206284|NCT00861250|"~     The primary objective of this study is to determine the rate of molecular remissions (MolR)~     assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone~     (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation~     (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.~   "
206285|NCT00861237|"~     After heart surgery, about 30% of patients suffer from atrial fibrillation. Patients are~     randomized into two groups receiving either potentized Strychnos Nux vomica or placebo under~     double blind conditions. Postoperatively, ECGs are done to monitor cardiac rhythm.~   "
206286|NCT00861224|"~     This study was conducted in conjunction with the 2 phase 3 studies of AMG 531 (20030105 and~     20030212) and an open-label extension study (20030213) and compared pretreatment and~     posttreatment bone marrow samples for the purpose of studying morphologic changes.~   "
206287|NCT00861211|"~     The purpose of the study is to determine whether senicapoc can decrease changes in FEV1~     following allergen challenge in atopic allergic subjects.~   "
206288|NCT00861198|"~     At the time of endoscopic retrograde cholangiopancreatography (ERCP) examination of the~     pancreaticobiliary system is done indirectly by radiologic means. Contrast is injected into~     the bile and/or pancreatic duct and outline of the duct is then viewed by fluoroscopic~     imaging. Frequently this is followed by diagnostic maneuvers (tissue acquisition) or~     therapeutic interventions (stone removal, stent insertion). Direct visualization of the bile~     and pancreatic ducts (cholangioscopy/pancreatoscopy) was developed 15 years ago and was shown~     to be superior to the indirect radiological view. The procedure did not become widely used~     secondary to high procedure related costs and equipment prone to failure. Recently a much~     improved (more affordable and more durable) cholangioscope was developed and approved by the~     FDA. The goal of this study is to prospectively record our experience with cholangioscopy and~     pancreatoscopy performed as medically indicated as part of standard medical care.~   "
206289|NCT00861185|"~     The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates~     exercise induced asthma symptoms.~   "
206290|NCT00861172|"~     It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional~     MRI insofar as physiopathology is not well-known: the precise sequences of events leading to~     plaque formation and axonal injury are still not completely understood.~      Some elements involved in plaque formation can be studied thanks to MR techniques~     (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral~     microcirculation's dysfunction).~      This study aims at giving a better understanding of MS plaques' physiopathology, using data~     from modern MRI through a longitudinal followed up with weakly MR 3T examination.~   "
206291|NCT00861159|"~     It is the investigators aim to determine the feasibility of directly detecting anti-RLIP76~     auto-antibodies in human serum using prepared RLIP76 antigen peptides in persons with~     rheumatologic disease and persons without rheumatologic diesease (healthy subjects).~   "
206292|NCT00861146|"~     The majority of individuals with alcohol problems remain current smokers, and the negative~     health consequences of smoking among these individuals are substantial. This study will~     investigate the impact of smoking cessation interventions initiated during intensive alcohol~     treatment on processes reflecting risk of alcohol relapse.~   "
206293|NCT00861133|"~     The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will~     enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.~   "
206294|NCT00861120|"~     The purpose of this study is to investigate the response rate in platinum-resistant, KRAS~     wild-type, ovarian cancer patients who are treated with pegylated liposomal doxorubicin~     (Caelyx®) in combination with biological treatment panitumumab (Vectibix®).~   "
206295|NCT00861107|"~     This is a Phase I/II study to investigate the feasibility of creating a personalized~     therapeutic cancer vaccine within the body. A vaccine contains a source of tumor antigen and~     an adjuvant. In this study, tumor antigen is generated by freezing a tumor by a minimally~     invasive percutaneous (through the skin) cryoablation procedure. The study drug, AlloStim, is~     injected into the ablated tumor to promote development of an anti-tumor immune response.~   "
206296|NCT00861094|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) together with radiation~     therapy may kill more tumor cells.~      PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different~     combination chemotherapy regimens to compare how well they work as first-line therapy in~     treating patients with esophageal cancer that cannot be removed by surgery.~   "
206297|NCT00861081|"~     The purpose of this study is to test a newly developed outpatient care intervention called~     SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke~     preventive services at Los Angeles County hospitals and to measure the costs of running such~     an intervention.~   "
206298|NCT00861068|"~     The objective of the trial is to investigate the analgesic efficacy of SPM 927 in subjects~     with moderate to severe neuropathic pain due to Postherpetic Neuralgia (PHN)~   "
206299|NCT00861055|"~     In the proposed study, the investigators plan to establish the burden of early onset (EO)~     neonatal sepsis in the newborn population born at Maela Refugee Camp over a two year period.~      Aims~        1. Define the contribution of Group B streptococcus(GBS) to this problem by establishing:~             -  The prevalence of maternal GBS carriage~             -  The prevalence of culture positive and culture negative EO GBS sepsis~             -  The perinatal risk factors for EO GBS cases~        2. Through these data assess the potential for intrapartum antibiotic prophylaxis using~          different strategies for reducing the burden of neonatal sepsis in this setting~        3. To define the serotypes and antibiotic susceptibility profile of carried and invasive~          GBS strains~        4. To evaluate the prevalence of serum antibodies to common GBS capsular serotypes in~          pregnant women in this population, the influence of carriage on serotype (ST)-specific~          antibody and the ST-specific antibody concentrations in the mothers of cases of~          confirmed and clinical GBS disease.~   "
206300|NCT00861042|"~     The primary objective of the trial is to assess the tolerability and safety of long-term SPM~     927 administration in subjects with diabetic neuropathy.~   "
206301|NCT00861029|"~     This is a Phase I, randomized, double-blind, placebo-controlled, study to estimate the~     effects of daily oral dosing of 800 mg pazopanib on electrocardiographic parameters (QTc~     interval duration) as compared with placebo in subjects with solid tumors. Moxifloxacin, will~     serve as a positive control.~   "
206302|NCT00861016|"~     This is an open-label, non-comparative, multi-centre clinical study to evaluate the Efficacy~     and safety of Metoprolol Succinate prolonged-release tablet (Betaloc Zok) in patients with~     mild to moderate essential hypertension.~   "
206303|NCT00861003|"~     This prospective study examines the differences among several measures of adherence to~     antipsychotic medications in outpatients with schizophrenia. Adherence is assessed by using~     self-report, physician report, pill count and electronic monitoring. The rates of~     adherence/non-adherence with various tools will be manifested. The association between~     antipsychotic adherence/non-adherence and various clinical status, including psychotic~     symptoms, depressive symptoms, side effects, neurocognitive function and insight are~     analyzed. Participants are assessed at baseline during a visit to their outpatient clinic and~     followed up for 8 weeks.~   "
206304|NCT00860990|"~     Spinal cord injury (SCI) often results in reduced bowel function and regularity, leading to a~     decrease in quality of life for those who are affected. Evidence-based research has indicated~     that, when surveyed, individuals with SCI express a greater reduction in quality of life~     derived from their bowel routine than able-bodied subjects. In addition, the extent of~     reduction in quality of life has a direct relationship with the level of Injury. Those with~     tetraplegia score worse than those with paraplegia and paraplegics score worse than controls.~     The development of an adequate quality of life questionnaire is needed to effectively~     identify the impact of bowel care on quality of life in patients with SCI compared to~     able-bodied controls. The purpose of this study is to determine the discriminatory ability of~     the survey for various diagnoses such as SCI, CVA, TBI, chronic back pain, radiculopathy from~     the Rehabilitation Service and able bodied persons.~   "
209469|NCT00819091|"~     Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have~     insufficient glycaemic control despite treatment with a sulfonylurea drug.~   "
206308|NCT00860938|"~     Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD)~     are more likely to be responsive to additional inhaled corticosteroids if they have a~     positive response to hyperosmolar challenge with mannitol than if their response is negative.~   "
206309|NCT00860925|"~     Major non-cardiac surgeries are common and major heart problems during or after such~     surgeries represent a large population health problem. Few treatments to prevent heart~     problems around the time of surgery have been tested.~      There is encouraging data suggesting that low-doses of Acetyl-Salicylic Acid (ASA) and~     Clonidine, which are two medications, given individually for a short period before and after~     major surgeries may prevent major heart problems.~   "
206310|NCT00860912|"~     The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female~     patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.~   "
206311|NCT00860899|"~     The purpose of this study was to investigate hypothesis that preoperative administration of~     epidural clonidine will reduce postoperative pain and systemic inflammatory stress response~     better than epidural levobupivacaine.~   "
206312|NCT00860886|"~     Background:~        -  Incidence of breast cancer is very low in Mongolia (6.6/100,000), especially in rural~          areas. Over the past 15 years, there has been considerable economic growth in Mongolia,~          resulting in migration to urban centers such as the capital, Ulaanbaatar, from areas~          with nomadic or semi-nomadic lifestyles. This recent migration offers an opportunity to~          study the endocrine profiles of premenopausal women as they acculturate to a more~          Western lifestyle.~      Objectives:~        -  To obtain new data on premenopausal endocrine and growth factor concentrations to assess~          possible variations by migration status within Ulaanbaatar; that is, to compare women~          who have been living in Ulaanbaatar for the longest period of time with those who have~          recently moved to Ulaanbaatar.~        -  To compare data from Mongolia with data from the United States (and possibly China),~          where women are at higher risk of breast cancer.~      Eligibility:~        -  A sample of 375 premenopausal women will be drawn from a larger sample of mothers whose~          children are participating in a study conducted by Harvard Medical School. Only mothers~          of girls will be included in this cross-sectional study. Women ages 25 44 years who are~          not pregnant or breastfeeding are eligible.~      Design:~        -  A total of 30 ml (three 10 ml samples) of whole blood will be collected. Women will be~          asked to provide a spot urine sample. These samples will be sent periodically to the NCI~          biorespository during the course of the study for testing. A portion of a sample for~          each participant will be kept in Ulaanbaatar in case of problems in delivery to the~          United States.~        -  The following hormones will be evaluated: testosterone, androstenedione,~          dehydroepiandrosterone (DHEA), DHEA-sulfate, estrone, estradiol, estriol, progesterone,~          prolactin, placental lactogen, IGF-1 and IGFBP-3, VEGF, soluble endoglin, and possibly~          other angiogenic proteins.~        -  Socioeconomic status and medical and lifestyle information will be assessed by~          questionnaire, including ethnicity, occupation, education, and migration status (e.g.,~          whether she moved from a rural area and time since migration). Breast cancer risk~          factors such as age at first pregnancy, age at first menstruation, gravidity (total~          number of pregnancies), parity (total number of childbirths), smoking status, alcohol~          use, and dietary intake will also be determined. (These questionnaires will have been~          pilot tested and revised before the start of this study.) The Global Physical Activity~          Questionnaire, developed by the World Health Organization, will assess physical~          activity.~        -  Mean and median premenopausal hormone concentrations of previously collected blood~          samples from women in the United States who are at high breast cancer risk will be~          compared with the Mongolian samples. In addition, Chinese data will be compared if~          available.~   "
206313|NCT00860873|"~     This study objective is to check the non-inferiority of the 2 formulations produced by EMS~     when compared with the same substances and pharmaceuticals forms of the product Condroflex~     (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and~     functional capacity that will be periodically measured by using the Visual Analog Scale of~     pain (VAS) and the questionnaire of Lequesne.~   "
206314|NCT00860860|"~     This study will investigate the toxicity, safety and pharmacokinetics of pretargeted~     radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled~     di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with~     In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the~     preliminary efficacy of the therapy.~   "
206315|NCT00860847|"~     1. Statement of Problem~           According to the National Fire Protection Association (NFPA), 43.7% of all firefighters~          that died on the job experienced sudden cardiac death. The job also affords an~          incredible amount of stress. Cholesterol therapy has been well demonstrated to reduce~          coronary plaque progression. However is certainly not the only factor in evaluating for~          progression of coronary artery disease (CAD), and other factors must play a role. Garlic~          therapy has been shown to retard atherosclerosis independently.~        2. Hypothesis and Specific Aims The hypothesis of this proposal is: In comparison to the~          placebo group, Aged Garlic Extract (AGE) therapy + Coenzyme Q10 (CoQ10) will be~          effective in slowing progression of coronary artery calcification (CAC) in firefighters~          with established atherosclerosis, independent of baseline blood pressure, statin use or~          other cardiovascular risk factors.~      Specific Aims:~        1. Compare the effects of cholesterol lowering effects in a firefighter population of~          patients under the influence of Aged Garlic Extract + CoQ10 or placebo.~        2. Compare whether degree of change in atherosclerotic coronary artery plaque burden will~          change at a different rate under the influence of Aged Garlic Extract + CoQ10 compared~          to placebo treatment.~        3. Compare whether Aged Garlic Extract + CoQ10 therapy induces changes in baseline values~          including biological and biochemical parameters, such as LDL cholesterol, homocysteine,~          C-reactive protein (CRP), and endothelial function.~   "
206316|NCT00860834|"~     Parents of children with asthma must work with their child's pediatrician to ensure that~     their child's asthma is managed well. Asthma coaches are one way to facilitate and support~     the relationship between parents and pediatricians. This study will evaluate whether access~     to a 12-month telephone asthma coaching program for parents is an effective way to improve~     asthma outcomes in children.~   "
206317|NCT00860821|"~     The purpose of this methodology study is to evaluate the effect of AZD8309 on cells and~     inflammatory biomarkers in nasal lavage and blood after nasal challenge with~     lipopolysaccharide (LPS)~   "
206318|NCT00860808|"~     The purpose of the study is the evaluation of the therapeutic benefit of intratympanic AM 101~     injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus~     following acute sensorineural hearing loss.~   "
206319|NCT00860795|"~     The goal of this study is to determine if Echinacea purpurea stimulates the immune system.~     For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo~     for 10 days. Blood will be drawn to assess immune markers just before beginning the study~     medication, during the 10 day course of medication and after completing the course of~     medication. It is postulated that adults receiving the Echinacea will have evidence of immune~     stimulation and those receiving placebo will not.~   "
206320|NCT00860782|"~     Children with sickle cell disease (SCD) are at risk for central nervous system (CNS)~     complications, which may affect academic achievement. This study will evaluate an educational~     support program for parents that aims to improve academic achievement in children with SCD.~   "
206321|NCT00860769|"~     The purpose of this randomized pilot study was to conduct an intervention with 68 rural women~     living with AIDS to compare the effectiveness of two different programs on compliance with~     HIV/AIDS treatment regimens, improvement in knowledge about HIV/AIDS and TB, improvement in~     psychological distress, reduction in stigma; satisfaction with care provided to family~     members, reduction in number of opportunistic infections, increase in CD4 levels and~     completion of the designed Asha-Life (AL) program. The trial was designed to assess the~     impact of the Asha-Life (AL) intervention engaging with an HIV-trained village woman, Asha~     (Accredited Social Health Activist), to participate in the care of women living with AIDS~     (WLA), along with other health care providers compared to a Usual Care group. Two high~     prevalence HIV/AIDS villages in rural Andhra Pradesh, which were demographically alike and~     served by distinct Public Health Centers, were selected randomly from a total of 16 villages.~   "
206322|NCT00860756|"~     Hypotheses:~        -  Hypothesis 1 - Sleep can be measured in Theater using actigraph technology.~        -  Hypothesis 2 - Standard sleep measures in Soldiers randomized to a sleep intervention~          group will more closely approximate normal as compared to sleep measures of Soldiers~          randomized to the control group.~   "
206323|NCT00860743|"~     The prevalence of obstructive sleep apnea is high in the Veteran population. If not treated~     promptly, sleep apnea may result in daytime fatigue which may lead to increased prevalence of~     accidents while driving or in the workplace. Recent large scale epidemiological studies have~     shown that the prevalence of excessive daytime sleepiness increases in individuals who suffer~     from obstructive sleep apnea. Obstructive sleep apnea may also result in the development of~     hypertension and other cardiovascular disorders. Previous findings have shown that subjects~     with sleep apnea have a greater risk for developing coronary vascular disease compared to~     individuals that do not suffer from sleep apnea Thus, a significant amount of evidence~     suggests that sleep apnea is a major health concern in the Veteran population. Consequently,~     determining the mechanisms that may impact on the severity of sleep apnea and increase the~     prevalence of cardiovascular incidents associated with this disorder is important, as is~     discovering novel treatments.~   "
206324|NCT00860730|"~     The clinical investigation is designed as a prospective and non-randomised study on a maximum~     of 150 patients. This study will be conducted at Investigational Centres in the European~     Community. A minimum number of 8 European Centres will be involved in the clinical~     investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The~     clinical follow-up requires evaluations at discharge (or 30 days if the patient is still~     hospitalized), 3-6 and 12 months following the procedure.The primary objective of this~     clinical investigation is to assess the performance of the Perceval S valve at 3-6 months~     after implantation in high surgical risk patients, who require a surgical intervention to~     replace the aortic valve.~   "
206325|NCT00860717|"~     Neuropathic ulcers are common sequelae of leprosy. The objectives of this study are to~     analyze the clinic-epidemiological characteristics of patients attended at one specialized~     dressing service from a leprosy-endemic region of the Brazilian Amazon and to evaluate the~     effect of Low Level Laser Therapy on wound healing of these patients.~   "
206326|NCT00860704|"~     Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese~     patients.~   "
206327|NCT00860691|"~     The purpose of this study is:~        -  to determine neutrophil activity in patients with colon cancer,~        -  to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon~          cancer patients and establish its prognostic value,~        -  to elucidate the relationship between serum sFas, sFasL and IL - 17 levels and~          clinicopathologic features of colon cancer,~        -  to compare the influence of laparoscopic and conventional procedures on postoperative~          serum sFas and sFasL levels in colon cancer patients~        -  to compare the influence of laparoscopic and conventional procedures on postoperative~          serum IL - 17 levels in colon cancer patients~        -  to compare the influence of laparoscopic and conventional procedures on postoperative~          neutrophil functions~        -  to confirm the expression of FasL protein in human colorectal cancer and elucidate the~          relationship between FasL expression and clinicopathologic features of the disease, to~          establish the prevalence of Fas in primary colon adenocarcinomas and elucidate the~          relationship between FasL expression and clinicopathologic features of the disease~        -  to determine the functional activity of tumour infiltrating neutrophils~   "
206328|NCT00860678|"~     A structured and supervised, 3-month physical activity intervention in patients after aortic~     valve replacement due to severe stenosis, accompanied by examination of cardiac size and~     function, exercise capacity and endothelial function before, three and six months after~     operation; comparison with a non-intervention control group.~   "
206329|NCT00860665|"~     Screening colonoscopy has been established as the most effective means of colorectal cancer~     prevention. This is based on the fact that colonoscopy detects and removes colonic polyps~     (adenomas) which are known to progress to cancer if left untreated. The present study~     examines the question whether case volume (i.e., the number of colonoscopies performed per~     year) correlates with colonoscopy quality, i.e., adenoma detection rate.~   "
206330|NCT00860652|"~     Radical prostatectomy (RP) is the most common curative approach offered to men with newly~     diagnosed prostate cancer. Unfortunately, up to half of these patients will have factors~     placing them at high risk of their cancer recurring. Having radiotherapy after RP is known to~     improve cure rates, but what is not known is whether it should be given straight after the~     operation or only when there is a rising PSA after surgery indicating active cancer.~     Immediate RT may not benefit all men, and can cause serious side effects such as bladder and~     bowel problems and impotence. International lack of consensus on the optimal timing of RT has~     resulted in varied clinical practice. This phase 3 trial will compare the two approaches.~   "
206331|NCT00860639|"~     The main objective of the study is to improve outcome of younger patients (between 18-60~     years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In this~     population, in the absence of bone marrow transplantation, event free survival (EFS) is~     estimated at 35% after three years of follow-up. Adjunction of gemtuzumab ozogamycin~     (MYLOTARG®) to standard chemotherapy is supposed to increase EFS up to 50% at 3 years. To~     test this hypothesis, the Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang~     (GOELAMS ) sponsored by Nantes University Hospital leads this randomized open phase III trial~     in 29 French centers.~   "
206332|NCT00860626|"~     For HBeAg(+) patients, interferon is used for 12 weeks. On 12th week of treatment, If HBV DNA~     is undetectable (<1000 copies/ml), interferon is continued alone for one year. If HBV DNA is~     still positive, nucleoside analogue is added for 3 months. After nucleoside analogue is added~     for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use~     interferon alone for another 6 months or longer. If HBV DNA is still positive, change to~     another nucleoside analogue or add another nucleoside analogue.~   "
206333|NCT00860613|"~     No dietary strategies have been designed and proved for Mexican pregnant women with diabetes.~     This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and~     gestational diabetes that were followed every two weeks until labor to assess the impact of~     the MNT program on metabolic control, maternal and fetal nutritional status and cost~     effectiveness. Participants were randomly assigned to one of three medical nutrition therapy~     (MNT) groups: the MNT 1 group (n=38) received usual medical treatment, counseling from a~     nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with~     an intensive educational component; MNT2 group (n=50) had the same treatment, but included~     only low-moderate glycemic index foods; and NO-MNT group (n=45) received the current hospital~     treatment. All women will receive a glucose meter so they do self glucose monitoring (pre and~     postprandial) 2 times a weeks 6 times a day. Weight gain, dietary consumption and glucose~     concentrations will be evaluated every two weeks. Fetal outcomes (weight, length and presence~     of complications)will be measured at labor.~   "
206334|NCT00860600|"~     This was a phase II multi-center, randomized, open-label study with two parallel study groups~     to evaluate the efficacy and safety of PG2 in ITP patients.~   "
206335|NCT00860587|"~     The objectives of the study were:~        1. To study risk factors for colonization and infection with antibiotic resistant bacteria~          among patients with severe IAI before and after antibiotic treatment and surgical~          intervention.~        2. To study species changes in the rectal flora among patients with severe IAI before and~          after antibiotic treatment and surgical intervention.~        3. To review guidelines for antibiotic use in participating units.~        4. To evaluate surgical antibiotic prophylaxis and treatment in relation to risk for~          colonization and infection with antibiotic resistant bacteria among patients with severe~          IAI~        5. To use the results from the study in the process of a more appropriate use of~          antibiotics in participating units and care of patients with severe IAI.~        6. To study the dynamics of extended-spectrum beta-lactamase producing and wild-type~          Enterobacteriaceae in patients with suspected severe intra abdominal infections before,~          during and after antibiotic treatment.~   "
206336|NCT00860574|"~     This phase II trial is studying how well giving treosulfan together with fludarabine~     phosphate and total-body irradiation followed by donor stem cell transplant works in treating~     patients with high-risk acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic~     leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body~     irradiation before a donor bone marrow or peripheral blood stem cell transplant helps stop~     the growth of cancer cells. It may also stop the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune cells and help~     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     tacrolimus and methotrexate before and after transplant may stop this from happening~   "
206337|NCT00860561|"~     This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in~     everyday practice. Secondary objective of this PMS is to identify the frequency of serious~     adverse events or any unknown adverse events of Faslodex.~   "
206338|NCT00860548|"~     The Scleroderma Cyclophosphamide Or Transplant (SCOT) Trial is a Phase II/III interventional~     trial comparing two treatments for early, severe scleroderma. These two interventions are~     high dose immunosuppressive therapy followed by autologous stem cell transplantation and~     monthly high dose pulse cyclophosphamide (the later for 12 doses). While standard of care~     might be considered the optimal control arm for a trial such as this one, no such standard of~     care is available for the population of scleroderma patients defined by the eligibility~     criteria for this trial. The rheumatologists on the protocol team believe that the SCOT~     cyclophosphamide regimen represents the best control arm for this study. However, given~     concerns over use of a treatment arm as a control that has not been established as a standard~     of care, this registry was established. The registry will be a prospective, observational~     study of subjects with severe systemic sclerosis (SSc) who are eligible to participate in the~     Scleroderma Cyclophosphamide or Transplantation (SCOT) Study but are denied insurance~     coverage or decline to participate prior to randomization. Subjects will be accrued over the~     same period as the SCOT study. Subjects will follow the course of treatment prescribed by~     their treating physician with no interference from the registry.~      The primary purpose of this study is to document the disease course and outcome in a group of~     participants who are eligible for the SCOT study, but declined to participate, in order to~     determine whether their outcome is better, worse, or no different than those who participate~     in the treatment phase of the trial.~   "
206339|NCT00860535|"~     This study will evaluate a gene expression signature (Growth Factor Signature [GFS]) as a~     biomarker for response/resistance to BRC-ABL oncogene inhibitors.~   "
206340|NCT00860522|"~     This is a Phase 1, open-label, dose escalation study of JVRS-100. The study will proceed in 2~     stages to minimize the number of patients treated at doses substantially below the~     recommended phase 2 dose. In stage 1, an accelerated titration schema will be followed with~     one patient at each dose level. Stage 2 will commence after a dose limiting toxicity is~     observed in stage 1 or after the maximum dose for stage 1 is reached. Stage 2 will follow a~     modified Fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2~     dose is determined. The cohort will then be expanded to a maximum of 12 patients to more~     fully evaluate the recommended phase 2 dose.~   "
206351|NCT00860379|"~     The selenium status of children with major burns is suboptimal which may increase the~     incidence of infection. Se requirements during critical illness are not known. Results from~     this investigation may provide a tool for recommending Se supplements during burn injury.~      The hypothesis of this research is that Se supplementation will restore the depressed Se~     status among children with burn injuries. The secondary hypothesis is that Se status is~     related to the incidence of infection among pediatric patients with burns.~   "
206341|NCT00860509|"~     The objective of this study is to compare cholesterol absorption and metabolism after feeding~     diets naturally low or high in phytosterols. All meals will be prepared in a metabolic~     kitchen and analyzed for phytosterols. In a randomized crossover design a group of up to 25~     healthy subjects will consume diets containing either 100 mg/day or 600 mg/day phytosterols~     for 4 weeks. At the end of each dietary period percent cholesterol absorption, fecal~     cholesterol excretion and LDL cholesterol level will be measured. The hypothesis is that LDL~     cholesterol and cholesterol excretion will be improved on the high phytosterol diet even~     though macronutrient composition, mineral intake and fiber consumption are similar.~   "
206342|NCT00860496|"~     A new immunosuppressive drug, based on the inhibition of important enzymes in the immune~     system, called JAK, is being developed by Pfizer to prevent transplant rejection. Since many~     treatments for transplant rejection may be administered together, this research study will~     analyze the effects of common transplant rejection therapies, Tacrolimus and Cyclosporine, on~     the JAK inhibitor, CP-690,550.~   "
206343|NCT00860483|"~     The purpose of the research is to determine how practicing laparoscopic motor tasks affects~     the functional anatomy of the brain, and to investigate whether there is a correlation~     between surgical experience and functional brain activition. Additionaly, the investigators~     plan to use eye-tracking technology to see if the use of this technology can distinguish~     surgeons of various skill levels. The investigators hope that this study leads to new and~     effective methods of training surgical residents. All of the data will be collected at The~     Feinstein Institute for Medical Research, and may be used in future studies, which may or may~     not be related to urological diseases.~   "
206344|NCT00860470|"~     The purpose of this community-based randomized trial is to examine whether a daily antenatal~     and postnatal multiple micronutrient supplement given to women will enhance newborn and~     infant survival and health and other birth outcomes in a rural setting in northwestern~     Bangladesh.~   "
206345|NCT00860457|"~     This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received~     any treatment for their disease.~      Current therapy for this disease includes the use of combination chemotherapy regimens~     containing Fludarabine and Rituximab, which have been found to be very effective for CLL. In~     this study, subjects will receive Fludarabine and Rituximab. After 3 cycles or 6 cycles of~     Fludarabine and Rituximab treatment, they will receive Lenalidomide. We are doing this~     research because we are attempting to improve the response, or outcome, of Fludarabine and~     Rituximab in previously untreated CLL patients. Lenalidomide is a drug that alters the immune~     system and it may also interfere with the development of tiny blood vessels that help support~     tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells.~     Lenalidomide is approved by the Food and Drug Administration (FDA) for treatment of specific~     types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients~     with multiple myeloma (MM). MDS and MM are blood disorders that involve different types of~     blood cells. It is not approved for chronic lymphocytic leukemia. It is currently being~     tested in a variety of cancer conditions. In this case it is considered experimental.~      This research is being done because we are attempting to find a better treatment for chronic~     lymphocytic leukemia. We do not know the effect of Lenalidomide following the regimen of~     Fludarabine and Rituximab.~      The hypothesis of the study is that adding Lenalidomide after the standard treatment regimen~     of Fludarabine and Rituximab will have better outcomes than treatment with Fludarabine and~     Rituximab alone.~   "
206346|NCT00860444|"~     Cardiovascular disease (CVD) is a serious health problem among African American women. This~     study will evaluate a health care center-based program that aims to encourage African~     American women to eat a low fat diet and increase their physical activity levels to reduce~     the risk of developing CVD.~   "
206347|NCT00860431|"~     1. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to~          standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD III-IV), on~          time to first occurrence of any event of the triple composite outcome of initiation of~          renal replacement therapy, decline of eGFR 50% or more or doubling of serum creatinine~          (sCr) when compared with standard-of-care group;~        2. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and~          proteinuria;~        3. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related~          quality of life;~        4. To evaluate the safety and tolerability of long-term AST-120 therapy in patients with~          CKD;~        5. To evaluate the all-cause mortality and hospitalization apart from those planned for~          operation and intervention)~   "
206348|NCT00860418|"~     Young inner-city children with asthma have the highest emergency department (ED) visit rates.~     Relying on the emergency department for asthma care can be a dangerous sign of poorly~     controlled asthma. This research will focus on whether having a specialized asthma nurse join~     the family at a child's doctor visit after an ED visit for asthma to make sure the child and~     parent keep the follow-up appointment and have the nurse remind the child's doctor to~     prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention)~     will result in young children with asthma having fewer days with wheezing and cough.~      The investigators hypothesize that:~        1. Significantly more children receiving the PAAL intervention will attend greater than 2~          non-urgent visits and greater than 6 refills for the child's anti-inflammatory~          medications over 12 months when compared to children in the control or standard asthma~          education group.~        2. Children in the PAAL intervention group will experience less morbidity and caregivers~          will experience increased quality of life compared to children in the control of~          standard asthma education group.~   "
206349|NCT00860405|"~     This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during~     elective open-heart surgery in pediatric patients.~   "
206350|NCT00860392|"~     This study will compare two approaches to the measurement of fatty acid oxidation (ketone~     body flux and ketone body concentration) and determine which method demonstrates superior~     sensitivity and variability in the detection of moderate increases in ketogenesis rates.~   "
206352|NCT00860366|"~     The purpose of this study is to determine whether the combined treatment with Uric Acid and~     rtPA is superior to rtPA alone in terms of clinical efficacy in acute ischemic stroke~     patients treated within the first 4.5 hours of symptoms onset.~   "
222411|NCT00647543|"~     The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol~     on patients from Thailand with high cholesterol.~   "
206353|NCT00860353|"~     The purpose of this study is to determine how well tolerated and safe AZD2551 is at different~     dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is~     absorbed into and cleared by the body~   "
206354|NCT00860340|"~     To determine if the beneficial effect of spironolactone in patients with congestive heart~     failure is in part due to its intrinsic inotropic action.~      Randomized, two group placebo controlled, single blind study.~   "
206355|NCT00860327|"~     Children who are born with heart defects undergo surgery when they are infants to correct the~     defects. However, many treatments that are used in pediatric heart patients were originally~     developed for adults and may not be the best option for children. This study will analyze~     tissue samples from newborns and infants undergoing surgery for heart defects to learn more~     about how a child's heart develops during the first year of life. This information may help~     to identify possible treatments geared specifically for the pediatric heart patient.~   "
206356|NCT00860314|"~     The aim of this study is to identify the one electrode position out of two most commonly used~     for external electrical cardioversion of typical atrial flutter, which needs less delivered~     energy and less needed number of shocks for successful cardioversion.~   "
206357|NCT00860301|"~     The purpose of this study is to investigate whether acupuncture influences:~        -  the rate of infants who still fulfil the colic criterion after three intervention weeks~        -  the time when the infants are crying, fussing or have intense bouts of colicky symptoms~   "
206358|NCT00860288|"~     This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes~     patients receiving vildagliptin as add-on therapy to metformin~   "
206359|NCT00860275|"~     The purpose of the study is to determine if the concomitant administration of either~     ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess~     safety and tolerability of BMS-708163~   "
206360|NCT00860262|"~     The primary objective of this trial is to demonstrate that following eight weeks of treatment~     the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line~     therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the~     monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe~     hypertension. A key secondary objective is to identify the duration of treatment required to~     demonstrate the superiority of the FDC over both of the monotherapies.~   "
206361|NCT00860249|"~     The purpose of this study is to evaluate whether patient outreach is effective at increasing~     compliance with preventative screenings for those patients who, based on national quality~     standards, have become newly eligible for screening measures. We hypothesize that educational~     outreach may increase completion rates.~   "
206362|NCT00860236|"~     A giardiasis outbreak in Bergen has given us the opportunity to approach two basic research~     questions of national and global importance:~        -  Studying the pathoimmunology of giardiasis in a natural setting, and following the~          genetic and immunological responses leading to recovery or persistent disease and~          sequelae.~        -  Studying the two disease entities FGID and CFS when induced by acute giardiasi and their~          risk factors.~        -  Interventional cognitive behavioural therapy is the only intervention documented to have~          significant effect on CFS outcome, and conventional cognitive behavioural therapy will~          be compared to a psycho-educational programme in the format of a randomised controlled~          trial.~   "
206363|NCT00860223|"~     The purpose of this study is to evaluate the potential effect of multiple doses of neratinib~     on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a~     single dose of digoxin.~   "
206364|NCT00860210|"~     This pilot feasibility study is assessing the safety and technical performance of the~     Neurostep™ System for the restoration of independent gait in subjects with gait disorder~     (i.e. foot drop) secondary to a CNS lesion (e.g. stroke).~   "
206365|NCT00860197|"~     This study will assess whether coffee consumption:~        -  increases immune responses~        -  decreases inflammatory status~   "
206366|NCT00860184|"~     Atherosclerotic plaque at the carotid artery bifurcation is a major source of stroke. The~     purpose of this investigation is to determine the ability of the SmartRisk software module to~     predict stroke or stroke-related events due to carotid plaque within a high-risk population.~     The SmartRisk software module operates on magnetic resonance images (MRI) of the carotid~     artery wall.~   "
206367|NCT00860171|"~     This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody~     BC8 when given before autologous stem cell transplant in treating patients with Hodgkin~     lymphoma or non-Hodgkin lymphoma that has returned after a period of improvement or does not~     respond to treatment. Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal~     antibody BC8, can find cancer cells and carry cancer-killing substances to them without~     harming normal cells. Giving iodine I 131 monoclonal antibody BC8 before an autologous stem~     cell transplant may kill more cancer cells.~   "
206368|NCT00860158|"~     This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk~     localized prostate cancer.~   "
206369|NCT00860145|"~     This study will compare radiosurgery (focused radiation, Gamma Knife Radiosurgery) with~     temporal lobectomy (standard surgical care) as a treatment of temporal lobe epilepsy.~     Patients who have seizures that begin in their temporal lobe that are not controlled with~     medications into the trial will be offered entry. Patients with a high likelihood of having~     their seizures controlled with open surgery will have treatment randomized between the~     standard surgery and radiosurgery. A prior study has shown that focused radiation~     (radiosurgery) may also reduce or eliminate seizures arising from the temporal lobe. The main~     study hypothesis is that radiosurgery is as safe and effective as temporal lobectomy in~     treating patients with seizures arising from the medial temporal lobe.~   "
206370|NCT00860132|"~     The economic and social burden of hip fractures is expected to increase dramatically, but~     financial resources remain limited. This calls for the investigation of innovative new forms~     of organization and integration of medical, surgical and rehabilitation services for these~     patients.~      The study will investigate economical aspects associated with implementation of a~     comprehensive orthogeriatric ward for elderly hip fracture patients in a general hospital,~     compared with the classic model of orthopedic treatment followed by rehabilitation period.~   "
222422|NCT00647400|"~     To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants~     with psoriasis~   "
206372|NCT00860106|"~     The purpose of this trial is to perform a prospective multicentric study to determine~     predictive ED score and D-dimer level in the evaluation of the thromboembolic event~     recurrence after anticoagulant treatment cessation.~      The patients are included in the study from the anticoagulant treatment cessation. An ED~     score and a blood sample are performed at this time and one month later. Then, the patients~     are followed up by phone for 2 years.~   "
206373|NCT00860093|"~     The purpose of this study is to evaluate the efficacy of MP-5971 in facilitating stone~     passage after Shock Wave Lithotripsy treatment.~   "
206374|NCT00860080|"~     The main purpose of this study is to determine whether three different single doses of PXL01~     are safe and well tolerated by healthy volunteers. The pharmacokinetic properties of PXL01~     (same doses) will also be investigated.~   "
206375|NCT00860067|"~     The objective of this study was to show that quadrivalent live attenuated influenza vaccine~     (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial~     vaccine, FluMist.~   "
206376|NCT00860054|"~     Studies have shown that phytosterols will lower LDL cholesterol. Typical diets can contain~     between 250 to 500 mg of naturally-occurring phytosterols. Long-term studies with~     phytosterol-containing products(such as margarines) have not taken into account the amounts~     of naturally occurring phytosterols in the diet. This means that the effects of small amounts~     of natural dietary phytosterols on LDL cholesterol are not known. In this study, we will~     examine the effects of phytosterols across a range of levels. The information will likely be~     used to further support and possibly extend the current dietary recommendations for~     phytosterol use.~   "
206377|NCT00860041|"~     RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may~     help doctors learn more about pain caused by paclitaxel and plan the best treatment.~      PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with~     cancer.~   "
206378|NCT00860028|"~     The purpose of this study is to determine whether extended pretreatment with varenicline~     (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well~     varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol~     consumption.~   "
206379|NCT00860015|"~     In patients with unresectable soft tissue sarcoma, what is the response rate if treated with~     Alimta and gemcitabine?~   "
206380|NCT00860002|"~     Uterine leiomyomas (i.e., fibroids, myomas) are the most common gynecologic tumors in women~     of reproductive age (1). Clearly, the majority of such lesions are asymptomatic (2). Symptoms~     directly attributable to these benign tumors represent the most common reason for laparotomy~     in non-pregnant women in the United States (3,4), and also in Taiwan (5). Whereas in decades~     past, hysterectomy was seen almost as a panacea for uterine leiomyomas, more recently~     attention has been paid to the development of pharmaceutical agents and less-invasive~     procedures (6). Frequently, such procedures are designed to retain the uterus (6). Of these,~     myomectomy may be a choice among the uterine-sparing treatments for symptomatic uterine myoma~     (7,8).~      The surgical mode of access usually employed in myomectomy is traditional exploratory~     laparotomy or its modification—mini-laparotomy (MLT) (9) or ultra-mini laparotomy (UMLT)~     (10,11), though recently, laparoscopy (12-14) or a combination of laparoscopy and MLT (9),~     vaginal surgery (15), and hysteroscopic myomectomy (16-21) have represented valid~     alternatives. However, myomectomy alone provides varying degrees of symptom control and a~     high percentage of recurrence, not only for the tumors themselves, but also for the symptoms.~     For example, one study reported that symptom resolution varied from 84.0% to 100% depending~     on different items and 21 (19.4%) of 108 patients experienced a recurrence after an average~     interval of 16 months (range, 1.8-47.4 months) (22). Therefore, an alternative or additional~     therapy might be required to provide longer durable symptom control and minimize tumor~     recurrence. One of the strategies is laparoscopic uterine vessel occlusion (LUVO), also known~     as laparoscopic uterine artery occlusion (LUAO) (23,24).~      The rationale for using LUVO in the management of symptomatic myomas is found in the~     successful experience with uterine-artery embolization (UAE), which was introduced in 1995 as~     an alternative technique for treating fibroids (25). Since then it has become increasingly~     accepted as a minimally invasive, uterine-sparing procedure, and studies have reported the~     relief of excessive menstrual bleeding or pressure in 80-90% of patients (26-32). LUVO~     provided similar relief of symptoms (89.4% with symptomatic improvement and 21.2% with~     complete resolution of symptoms) in 2001 in a 7- to 12-month follow-up of 87 patients after~     LUVO (33).~      Since that time there has been rapid growth in the use of this treatment with various~     modifications, such as simultaneous accompaniment with myomectomy either through laparoscopy~     or ML, and there has been considerable research into its outcome (22,34-42). However, in our~     previous data, we found that a combination of LUVO and myomectomy provided definite~     effectiveness in symptom control for these women with symptomatic uterine myomas (98.1% to~     100% symptom resolution depending on various kinds of items), minimized tumor recurrence, and~     rendered the vast majority of re-interventions unnecessary (22). Myomectomy can be performed~     by the laparoscopic approach or by ML when patients are undergoing the LUVO procedure. Before~     2002, we often used ML to perform myomectomy (22). However, we have shortened the incision to~     less than 4 cm, creating ultramini-laparotomy (UMLT) to perform myomectomy (10,11,43).~      Since many conservative therapies might provide less or more therapeutic effects on the~     symptom control and disease status, the aim of this prospective study tries to evaluate the~     therapeutic outcomes of these symptomatic uterine myomas after different kinds of therapies~     in the coming 5 years at Taipei Veterans General Hospital.~   "
206381|NCT00859989|"~     RATIONALE: A diet and physical activity program followed by a weight-loss maintenance program~     may help obese black women lose weight. It is not yet known whether a weight-loss program is~     more effective than a general health education program in helping obese black women lose~     weight. Weight loss may reduce a person's risk of developing cancer.~      PURPOSE: This randomized phase III trial is studying a weight-loss program to see how well it~     works in helping obese black women lose weight.~   "
206382|NCT00859976|"~     The randomised controlled trial will be carried out on patients that require a total hip~     replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint~     to the bone is by coating the implant to encourage the body to grow bone onto the replacement~     hip. This study is aiming to find out whether the new (Bonemaster) coating allows increased~     bony growth onto the cup when compared to the usual (plasma-sprayed) coating. This may reduce~     the incidence of early failures due to poor bony attachment, which is a well known~     complication for early failure of total hip replacements.~      The study will compare two different types of coating (BoneMaster and Plasma-sprayed) on the~     cup of the replacement hip. Density of the bone immediately surrounding the cup will be~     observed to see if there are differences between the two groups. The density of bone will be~     measured using standard x−ray assessment and in a smaller sample of 14 patients, using a~     special scan called Dual Energy X−ray Absorptiometry (DEXA Scan). Functional comparisons will~     be assessed through clinical scores.~   "
206383|NCT00859963|"~     The purpose of this prospective clinical data collection is to document the performance and~     clinical outcomes of the Regenerex™ Tibial Tray.~   "
206384|NCT00859950|"~     Sleep apnea is a common sleep disorder characterized by temporary stops in breathing during~     sleep and has been associated with the development of cardiovascular disease. This research~     will investigate one potential mechanism leading to the development of cardiovascular~     disorder, specifically, the blockage of blood vessels called vascular occlusion, in~     subjects with sleep apnea. A group of healthy controls will be used for comparison. All~     subjects will undergo clinical evaluation followed by an overnight sleep study and a morning~     blood draw. Subjects with sleep apnea will be treated according to standard clinical~     management and followed under the research protocol for one month. At the end of one month, a~     repeat blood draw will be performed on the sleep apnea subjects for comparative analysis. If~     a control subject is found to have any abnormality during this research study, he or she will~     be referred for further clinical evaluation.~   "
206385|NCT00859937|"~     This phase II trial is studying how well dasatinib works in treating patients with malignant~     salivary gland tumors that have come back after treatment or have spread to other parts of~     the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~   "
206386|NCT00859911|"~     This is a study of the effectiveness of multiple micronutrient supplements given by teachers~     to their pupils on growth and educational achievements. The hypothesis is that children are~     deficient in multiple micronutrients and that supplements will lead to improved weight gain,~     growth in height and better educational achievements in tests of mathematics and language. It~     is also hypothesised that micronutrients will help prevent the build up of arsenic consumed~     in food and water as a result of geological contamination of water sources.~   "
206387|NCT00859898|"~     The primary purpose of this study is to compare the change from baseline in hemoglobin A1C~     achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin~     XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral~     administration of double-blind treatment. The safety of treatment with dapagliflozin will~     also be assessed in this study~   "
206401|NCT00859703|"~     Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal~     women with early-stage breast cancer. This treatment induces bone loss and a higher risk of~     fractures.~      This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and~     osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast~     cancer~   "
206388|NCT00859885|"~     The prevalence of patent foramen ovale (PFO) is about 25% in the general population and~     approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke).~     Given the large number of asymptomatic patients, no primary prevention is currently~     recommended. On the contrary, secondary prevention is very important. Prospective studies~     have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the~     risk of recurrent stroke associated with a PFO. Patients with spontaneous or large~     right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple~     ischemic events prior to the PFO diagnosis may still be at increased risk of stroke~     recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to~     ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients~     treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing~     the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing~     RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates.~     Alternative data-gathering strategies such as multicenter registries are needed to overcome~     the low recruitment rates. The aim of the present study is to compare the risk of recurrent~     stroke and TIA in patients with PFO and otherwise unexplained stroke who undergo PDC or~     receive ATT.~   "
206389|NCT00859872|"~     This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment~     sessions, parallel-group study.~      After screening period, eligible subjects will be entered 5 days treatment session I to~     compare the efficacy between risperidone oral solution combination clonazepam oral and~     haloperidol IM injection on controlling psychotic agitation, then will be followed by 6~     additional weeks treatment session II for exploring the effect of medicine switching from IM~     injection to oral.~   "
206390|NCT00859859|"~     The purpose of this study is to examine the short-term effects of vagus nerve stimulation~     (VNS) by auricular stimulation (stimulation of the auricular branch of the vagus nerve which~     innervates the ear) in rheumatoid arthritis (RA). RA is characterized by a chronic systemic~     inflammation affecting the joints but also carries an increased risk for extra-articular~     manifestations as well as other organ manifestations such as cardiovascular disease (CVD),~     which significantly contributes to morbidity and mortality in this disorder.~   "
206391|NCT00859846|"~     The use of ultrasound is becoming widespread to guide the placement of arterial lines for~     both vascular access and regional anesthesia in the field of anesthesia. Arterial line~     placement can be challenging, especially in the pediatric population. Frequently multiple~     attempts are required with relatively high failure rates. This can result in excessive needle~     punctures and extended OR times. A few studies have looked at the use of ultrasound to~     decrease OR time and increase success rates both in adult and pediatric populations. These~     studies compared the traditional palpation method with either short axis or long axis views~     of the vessel using ultrasound guidance. No study to date has compared short axis and long~     axis views for arterial line placement in either the pediatric or adult population. Our study~     compares success rates and OR times when long and short axis methods of arterial line~     insertion are employed in the pediatric population.~   "
206392|NCT00859833|"~     We will test the hypothesis that a single dose of Regadenoson will produce equivalent degrees~     of coronary hyperemia in patients of widely different body size. This will be a prospective,~     open-label, comparative trial using MRI to measure myocardial perfusion reserve (ratio of~     myocardial blood flow with vasodilator to myocardial blood flow at rest) during sequential~     administration of the coronary vasodilators adenosine and regadenoson. Non-invasive MRI~     measurements of resting myocardial blood flow, and sequential measurements of blood flow~     during adenosine infusion (weight adjusted dosing) and then blood flow during regadenoson~     infusion (single, fixed dose. Blood flow measurements will be obtained sequentially and in~     the same sequence in each subject during a two hour MRI exam. 32 subjects will be recruited~     for this study. The first 2 will be for testing of the protocol. Inclusion criteria: 2~     subjects for initial protocol evaluation, then 30 subjects with body mass index (BMI) between~     18 and 40. Exclusions are pregnancy, renal dysfunction and claustrophobia.~   "
206393|NCT00859807|"~     The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer)~     and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).~   "
206394|NCT00859794|"~     The overall goal of this project is to better understand the micro-physiology of human~     epilepsy and cognition using the intracranial electroencephalogram (iEEG), electrical brain~     stimulation, functional magnetic resonance imaging (fMRI), and histology.~   "
206395|NCT00859781|"~     The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591~     in combination with ketoconazole and hydrocortisone against prostate cancer.~   "
206396|NCT00859768|"~     The purpose of this study is to evaluate the effectiveness and feasibility of the Screening~     Inventory of Psychosocial Problems (SIPP) in consultation settings with respect to early~     recognition and treatment of psychosocial distress, communication between patients and~     physicians, and psychological distress and quality of life in cancer patients treated with~     radiotherapy (RT).~   "
206397|NCT00859755|"~     This is a Phase 1 study, involving a 1-day dosing period, designed to test the safety of~     investigational study drug ARRY-403 in patients with Type 2 diabetes. Approximately 36~     patients from the US will be enrolled in this study.~   "
206398|NCT00859742|"~     The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal~     re-staging after induction treatment in patients with non-small cell lung cancer.~      Primary objective:~      1. To determine the sensitivity, specificity, positive predictive value, negative predictive~     value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal~     re-staging after induction treatment.~      Secondary objectives:~        1. To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal~          re-staging~        2. To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after~          induction therapy~        3. To determine procedure related complications~   "
206399|NCT00859729|"~     This study will assess the feasibility and safety of vaccination with increasing doses of~     xenogenic DNA administered intradermally in combination with electroporation in patients with~     relapse of prostate cancer. The DNA encodes prostate specific antigen (PSA) from Rhesus~     Macaque (Macaca mulatta), a protein that is 89% homologous to human PSA. The study will also~     assess the safety and functionality of the DERMA VAX™ (Cyto Pulse Sciences) DNA vaccine~     delivery system.~   "
206402|NCT00859690|"~     Sleep Apnea is a prevalent condition that has been increasingly diagnosed in the adult~     population and is now considered an independent risk factor for the development of~     cardiovascular disease. A better understanding of the mechanisms associated with the~     development of cardiovascular disease in sleep apnea is needed.~      This research will investigate the function of the adenosine deaminase (ADA) in subjects with~     sleep disorders. This enzyme is responsible for metabolizing adenosine, a neuromodulator that~     is released during periods of sleep apnea and that has been found to promote vascular~     thrombosis. There are multiple types of ADA that are genetically determined and have~     different levels of function. Those different forms of this enzyme may determine groups that~     are more susceptible to the development of thrombosis. Given the known association between~     sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are~     differentially found in subjects with sleep apnea as compared to other sleep disturbances.~     The overall objective of this experiment is to assess the presence of ADA polymorphisms in~     sleep apnea.~   "
206403|NCT00859677|"~     The purpose of this study is to investigate the role of T helper 17 cells (Th17) in the~     pathogenesis of MRSA infections.~   "
206404|NCT00859664|"~     Children with autism are often treated with psychiatric drugs. These medications have been~     shown to improve their language and social function, and are important in improving their~     quality of life. In many cases it is difficult to determine the best drug dose, and a~     favorable response occurs in only 30%-70% of individuals, with many children suffering~     significant adverse drug reactions.~      Pharmacogenetics is the study of the role of different genes on drug behavior. The cytochrome~     P450 is the most important enzyme, involved in the metabolism of a vast number of drugs,~     including psychiatric medications. The multiple variations in this gene can result in the~     different response observed in different patients, even when treated with similar doses of~     the drug.~      Hypothesis(es):~      Mapping the different types of cytochrome P450 gene, in children with autistic disorders will~     improve the rate of success of medical treatment, and prevent adverse drug reactions.~      Potential Impact:~      If successful, our study can help thousands of children and their families by developing a~     system of tailored medicine that is based on the specific activity of the various enzymes~     present in that particular patient. Better medical treatment will facilitate better daily~     interactions with the children and enhance their quality of life. Furthermore, recognizing~     children that are resistant to medication will prevent unnecessary use of drugs.~      It should be noted this is the first study focusing on children receiving psychiatric~     medications using pharmacogenetics. Found to be effective, this method can also be applied to~     other groups of medications and to other patients.~   "
206405|NCT00859651|"~     This is a phase II study which will enroll 20 postmenopausal women who are at high risk for~     breast cancer development. The goal is to determine whether a one-year intervention of~     high-dose vitamin D at 2 different doses (20,000 IU weekly or 30,000 IU weekly) will increase~     circulating blood levels of vitamin D and to obtain preliminary data on the biologic effects~     of vitamin D for breast cancer prevention.~   "
206406|NCT00859638|"~     People who have long-term conditions such as heart disease, diabetes, arthritis etc. face~     challenges in staying active and able to participate in activities that are important to~     them. There is some research that suggests that a care model that focuses on physical~     functioning and helping patients to manage their own conditions will assist them to stay~     active and healthy longer. In this project, the investigators are testing whether~     physiotherapy and occupational therapy offered to groups of patients and information about~     rehabilitation offered to other members of the health care team can help people with chronic~     conditions to maintain their physical abilities.~   "
206407|NCT00859625|"~     Hypothesis-- Nurse observation in addition to the colonoscopist while withdrawing the~     colonoscope from the cecum leads to a greater adenoma detection rate.~      Methods- Patients presenting for screening colonoscopy are randomized to nurse observation or~     usual practice. Risk factors for adenoma development and the adenoma detection rate in each~     group will be evaluated.~   "
206408|NCT00859612|"~     There are two major goals of this project:~        1. Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination~          of the prevalence of low bone turnover in CKD-5 patients with bone loss.~        2. Identification of the optimal combination of noninvasive tests for definition of the~          turnover component of ROD.~   "
206409|NCT00859599|"~     The purpose of this study is to evaluate the efficacy and safety of monochromatic~     phototherapy (Biolight®) on foot ulcers in diabetic patients, in comparison of placebo~     phototherapy as a complementary to standard diabetic foot ulcer therapy.~      The study initiated with a four week long Run In Period to eliminate spontaneous healing~     ulcer to be included. Treatment with monochromatic phototherapy (Biolight® or placebo) will~     be given locally, additional to standard care, three times weekly during the first four weeks~     and twice weekly the following sixteen weeks or until the ulcer is completely healed,~     according to a pre-determined treatment plan. The area of the ulcer will be measured once~     weekly for 20 weeks or until the ulcer is completely healed.~   "
206410|NCT00859586|"~     Patients receiving allogeneic stem cell transplantation for hematological malignancies who~     suffer a relapse of their disease post-transplant have limited treatment options and a poor~     prognosis. With the exception of patients with chronic leukemias who may achieve prolonged~     remissions after donor lymphocyte infusions (DLIs), treatments using either chemotherapy or a~     DLI achieve less than a 10% median survival beyond 6 months. Most of these patients die of~     progressive leukemia, underlying the need for new therapeutic approaches.~      Human leukocyte antigen (HLA)-mismatched DLIs appear to possess a more potent~     graft-versus-leukemia (GvL) effect. However, when given after an HLA-mismatched transplant~     DLIs have a high risk of causing graft-versus-host disease (GvHD), which can be severe. To~     reduce the risk of GvHD, infusions of mismatched lymphocytes from an alternative donor may be~     used to avoid permanent engraftment and associated risk of GvHD.~      In this study, we propose to use a novel strategy to treat leukemias relapsing after HLA~     matched allogeneic stem cell transplantation by using haplo-identical DLIs to promote the~     associated antileukemic effect while minimizing the possibility of permanent engraftment and~     associated GvHD. To achieve only temporary engraftment and to promote disease control we will~     give fludarabine immunosuppression prior to the DLI. We anticipate the infusion of~     HLA-mismatched donor lymphocytes in this setting will produce no detectible engraftment or~     only temporary engraftment, but may result in a strong GvL effect regardless of engraftment~     outcome. We will select patients for this protocol who fall into the worst category for~     post-transplant relapse. Specifically, we will enroll patients with acute leukemia or MDS~     relapsing within 6 months of transplant, of which less than 5% survive beyond a year from~     relapse.~   "
206458|NCT00858923|"~     Tulane University Health Sciences Center/Louisiana Community AIDS Research~      Center Program, New Orleans, LA is seeking patients for an HIV study. The~      purpose of the study is to test the safety and effectiveness of an~      experimental ultra-violet light device designed to reduce virus in your blood.~   "
206411|NCT00859573|"~     Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10~     week, double bind, placebo controlled, randomized clinical trial to receive either modafinil~     or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential~     facility to achieve initial abstinence and be inducted onto study medication during wks 1-2.~     Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly~     psychotherapy while continuing to receive study medications. Urine samples will be collected~     thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the~     results of this study will contribute to our understanding of which types of agents may be~     good candidates for further development as potential treatment agents for this disorder.~   "
206412|NCT00859560|"~     The retrospective survey is to investigate the incidence of bone fracture in post-menopausal~     breast cancer patients with Arimidex 1mg, who were previously registered for the clinical~     experience investigation.~   "
206413|NCT00859547|"~     The objective of this study is to assess the safety and immunogenicity of recombinant~     thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin~     grafting in pediatric patients, newborn through 17 years of age.~   "
206414|NCT00859534|"~     Urticaria is one of the most common dermatological conditions with diverse clinical~     presentations and causes. Solar urticaria (SU) is a rare subset of physical urticaria, where~     symptoms are induced by direct exposure of the skin to sunlight. As little as 5 minutes of~     sun exposure can cause flares and whealing on exposed skin sites, accompanied by severe~     itching. The wavelengths of radiation causing the eruption (i.e. the action spectrum) are in~     the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have a~     very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A~     delayed form of SU has also been reported, although this is extremely rare. Information on~     the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed~     to direct sunlight. The condition can be very distressing and severely impair the~     individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy,~     i.e. oral antihistamines, is only partially effective and may provide little worthwhile~     relief of symptoms.~      This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic~     treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining~     the minimum urticarial dose before and after treatment.~   "
206415|NCT00859521|"~     THe objective of this study is to compare the rate and extent of absorption of an~     investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the~     commercially available reference product under fasting conditions.~   "
206416|NCT00859508|"~     Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to~     or is substantially equivalent to other dura replacements for the repair of the cranial dura~     in patients undergoing surgical repair of the cranial dura.~   "
206417|NCT00859495|"~     The primary objective of the study is to determine the feasibility (as determined by lack of~     serious adverse events) and tolerability (as determined by patient's ability to complete the~     study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous~     chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.~   "
206418|NCT00859482|"~     Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene~     4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade~     of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also~     with central nervous system (CNS) immune surveillance.~   "
206419|NCT00859469|"~     In patients with pleural or peritoneal mesothelioma, what is the response rate to combined~     Oxaliplatin (ELOXATIN®) and Gemcitabine chemotherapy?~   "
206420|NCT00859456|"~     The purpose of this study is to determine the clinical response rate (complete response and~     partial response) in patients with metastatic, locally advanced, or locally recurrent~     vascular soft tissue sarcoma treated with sunitinib.~   "
206421|NCT00859430|"~     The objective of this study is to compare the rate and extent of absorption of an~     investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the~     commercially available reference product under fed conditions.~   "
206422|NCT00859417|"~     The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In~     front of the high rate of recurrences with this technique, the use of synthetic prosthesis~     made their appearance. But the drawback of the use of prosthesis is their tolerability. The~     system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high~     efficiency in the correction of the prolapse while reducing the risk of complications. The~     lack of prospective and randomized studies makes difficult to assess the interest. The~     investigators, therefore, have put in place a randomized prospective study seeking the~     evaluation of the system Perigee® compared to the conventional surgical technique.~   "
206423|NCT00859404|"~     The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable~     mild to moderate persistent asthma. The study involves two weeks of run in period. This is a~     placebo controlled study. One of the four treatment arms is placebo. The duration of~     treatment is 12 weeks.~   "
206424|NCT00859391|"~     This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of~     gluten with ALV003 or with placebo when ingested by CD Subjects.~   "
206425|NCT00859378|"~     The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures.~     Traditionally, the cemented version of the semiendoprosthesis has been used for this~     indication. However, the cementing carries a risk of fat embolism during the pressurization~     of the cement. The fat embolism can be avoided when using the non-cemented~     semiendoprosthesis. In this study we want to find out whether there are any differences in~     the treatment results between the cemented and non-cemented semiendoprostheses when treating~     the proximal femoral fractures.~   "
206440|NCT00859157|"~     RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known~     whether tumescent mastectomy or standard mastectomy results in less pain in women with breast~     cancer.~      PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain~     after standard mastectomy in women with stage I, stage II, or stage III breast cancer.~   "
206441|NCT00859144|"~     This study will examine methods for involving local community members in programs to teach~     urban youth about how to prevent transmission of HIV.~   "
206426|NCT00859365|"~     This study aims to examine the efficacy of an Integrative approach utilizing Acupuncture as~     an add-on therapy for the treatment back and neck pain in an emergency department setting~      Acupuncture is well established as an effective treatment for back pain. The investigators~     cumulative experience in Asaf Harofeh Medical Center has shown Acupuncture to be an Effective~     therapy for simple back and neck pain in an ER setting.~      This study will examine weather Acupuncture can decrease pain, increase range of motion and~     decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain~     without neurological findings. Acupuncture will be performed as an add on therapy on top of~     analgesic therapy.~   "
206427|NCT00859352|"~     The primary objective of the study is to investigate if the exposure of midazolam is~     clinically significantly changed by 14 days of exposure to AZD1981 through possible enzyme~     induction of CYP3A.~   "
206428|NCT00859339|"~     This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine~     followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the~     Bladder.~   "
206429|NCT00859313|"~     This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab®~     PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain~     medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after~     undergoing knee replacement surgery.~      Another goal of this study is to assess the safety and effectiveness of this non-invasive,~     sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient~     experiences following knee replacement surgery.~   "
206430|NCT00859300|"~     We propose a comparative case-control study on the 2 following groups of patients:~        -  Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial~          infarct,~        -  Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial~          infarct.~      The primary endpoint in this study is the correlation phenotype/genotype of sudden death at~     the acute phase of myocardial infarct.~      The first phase of the study, including patients' recruitment, clinical and biological data~     collection, will last 82 months. The second phase will concern the genotype/phenotype~     analysis and the identification of polymorphisms associated with a sudden death risk after a~     myocardial infarction.~      This study will allow a better knowledge of the mechanisms of sudden death and the~     identification of new risk markers.~   "
206431|NCT00859287|"~     This open label, non-interventional study is to compare the efficacy of Omepral® tablet and~     any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various~     type of acid reflux related symptoms in patients with reflux esophagitis.~   "
206432|NCT00859274|"~     It is generally accepted that symptoms and lung function are not sufficient ways to monitor~     asthma control. Therefore, several objective tests have been developed to help asthma control~     monitoring, each having their own shortcomings. We have developed a new test, the hypertonic~     saline cough challenge. In our previous publication this test has proven useful in diagnosing~     asthma. The present study is planned to investigate whether hypertonic saline cough challenge~     could be used to monitor asthma control. A group of steroid-naive asthmatics will be~     recruited. A treatment with inhaled budesonide is started. Asthma control is monitored at~     regular intervals utilising a validated questionnaire. At the same time points, hypertonic~     saline cough challenges will be performed. We will analyse whether changes in the~     responsiveness to the cough challenge reflects the changes in asthma control~   "
206433|NCT00859261|"~     The study purpose is to help in the developement of 3 dimensional breast ultrasound imaging.~   "
206434|NCT00859235|"~     Percutaneous endoscopic gastrostomy (PEG) is commonly used for long term enteral feeding of~     patients with severe dysphagia. The most common complication is peristomal wound infection.~     The possible mechanism the bacterial from the oral cavity disseminate during the PEG~     insertion through the stomach to the abdominal wall, in spite the routine use of antibiotic~     prophylaxis, have reported low rates of wound infection in patients who were already~     receiving antibiotics at the time of PEG Our hypothesis that washing the oral cavity with~     antibiotic solution prior the insertion PEG , We planned a prospective, randomised, double~     blind, one centre study of antibiotic mouth wash solution (0.2% Chlorhexidine gluconate)~     as.prophylaxis in PEG~   "
206435|NCT00859222|"~     The purpose of this research study is to determine the amount of LBH589 that can be given to~     people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination~     with bevacizumab is a drug combination that may stop cancer cells from growing abnormally.~     LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA~     approved for use in patients with colorectal cancer and has been studied extensively in other~     types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but~     information from other studies suggests that the combination may help prevent the growth of~     the participant's tumor.~   "
206436|NCT00859209|"~     The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a~     double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent~     the arterial CO2 (PaCO2).~   "
206437|NCT00859196|"~     In previous in vitro studies it could be shown, that Dexpanthenol has an influence on the~     gene expression of fibroblasts. The genes which are influenced by Dexpanthenol play mainly a~     role during cell proliferating processes.The aim of this study is to investigate the~     molecular effect of Dexpanthenol on human living skin, during wound healing.~   "
206438|NCT00859183|"~     Despite recent advances in interventional cardiology including the success of drug-eluting~     stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a~     challenging clinical issue. Given the efficacy of the systemic sirolimus administration to~     prevent neointimal hyperplasia in animal models and to halt and even reverse the progression~     of allograft vasculopathy, the aim of the present double-blind, placebo-controlled study was~     to evaluate the efficacy of a 10-day oral sirolimus treatment with two different loading~     regimens for the prevention of recurrent restenosis in patients with in-stent restenosis.~   "
206439|NCT00859170|"~     The objectives of this post-market evaluation are~        1. to assess the capacity of the procedure to be completed with use of only a semi-rigid~          ureteroscope, without requiring use of a flexible ureteroscope~        2. to compare the rate of retropulsion and the time required to complete the lithotripsy in~          patients in which the Accordion device is used in contrast to when such a device is not~          employed.~   "
206443|NCT00859118|"~     The main purpose of this study is to see what changes happen to the tumors while taking the~     axitinib and after it is stopped (during the scheduled breaks), and what changes in the tumor~     may be responsible for this growth. This will be done by using a special kind of scan called~     an 18F-FLT PET/CT.~      In addition, the investigators want to find out how the drugs are processed and distributed~     in the human body. The investigators will also look at how different types of cancer are~     affected by axitinib. The investigators will also correlate vasculature kinetics extracted~     from the dynamic FLT PET/CT imaging with the vasculature kinetics extracted from DCE-CT.~   "
206444|NCT00859105|"~     Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor),~     Placebo Control, Parallel Assignment, Bio-equivalence Study~   "
206445|NCT00859092|"~     Swallowing dysfunction and delay of oral feeding skills in premature infants significantly~     delay discharge from the hospital. Thickening oral formula or breast milk feeds with~     commercial thickeners and rice cereal has been used in some nurseries with the goal of~     promoting development of adequate feeding skills. The objective of this pilot study is to~     examine the effect of thickened feeds on premature infants with oral feeding difficulties due~     to dysfunction secondary to immature swallowing.~      Hypotheses:~        -  Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in~          32-40 weeks gestational age infants when compared to non-thickened feeds~        -  Thickened feeds will promote transition to hospital discharge.~   "
206446|NCT00859079|"~     The aim of the investigators study was to compare for the first time efficacy and safety of~     intravenously administered GLP-1 with an established intravenous insulin regimen in~     hyperglycaemic type 2 diabetic patients.~   "
206447|NCT00859066|"~     The purpose of this study is to quantify levels of resident anxiety under the current system~     (take call alone) and compare results to a modified system.~   "
206448|NCT00859053|"~     The purpose of this study is to assess the effects of hepatic impairment on the single dose~     pharmacokinetics of BMS-790052.~   "
206449|NCT00859040|"~     The purpose of this research study is to evaluate the effectiveness and safety of SOM230C in~     treating recurrent meningiomas. SOM230C is a newly discovered drug that may stop meningioma~     cells from growing abnormally. This drug has been used in treatment of other tumors, and~     information from those other research studies suggests that SOM230C may help to stop the~     growth of meningiomas.~   "
206450|NCT00859027|"~     Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as~     leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal~     suppression and demonstrate increased bone turnover and consequent bone loss at the hip and~     spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.~   "
206451|NCT00859014|"~     The purpose of this research study is to find out if bone marrow treatment (bone marrow~     aspiration and infusion of stem cells) can be safely used in adults who have recently (within~     24-72 hours)suffered an acute ischemic stroke.~   "
206452|NCT00859001|"~     Study phase: Phase II Investigational product, dosage, and route of administration:~     Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab)~     covalently bound to the chelating agent tiuxetan. To prepare the active therapeutic agent~     [90Y]-ibritumomab tiuxetan, the antibody is chelated with the β-emitter yttrium-90 chloride~     immediately before intravenous administration. Treatment with [90Y]-ibritumomab tiuxetan is~     preceded by an infusion of rituximab (Rituxan, Mabthera) in order to optimize the~     biodistribution of radiolabeled antibody by depleting CD20 positive B-cells. Rituximab is a~     chimeric human/murine IgG1 monoclonal antibody. The Zevalin study regimen is given as an~     infusion of rituximab 250 mg/m2 and (where biodistribution imaging or dosimetry is~     compulsory) 185 MBq (5mCi) of [111In]-ibritumomab tiuxetan on Day 1 followed 7 to 9 days~     later by a single dose of 14.8 MBq/kg (0.4 mCi/kg) of [90Y]-ibritumomab tiuxetan, maximal~     dose of 1184 MBq (32 mCi), preceded by 250 mg/m2 of rituximab.~      Indication: stage II-IV follicular lymphoma (FL) grade I-II after 4 cycles of FMR Study~     objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan, as well as~     assessment of quality of life Patient population: Patients with after 4 cycles of treatment~     with FMR Study design: Prospective, multicenter, open-label study designed to treat patients~     with a sequential front-line treatment represented by 4 cycles FMR plus Zevalin Duration of~     treatment: Four months for FMR and two treatment days one week apart followed by a 12-week~     safety period for Zevalin Duration of study: Estimated duration of study is 18 months Primary~     efficacy parameter: Overall response rate and complete response rate Secondary efficacy~     parameters: Overall survival, Disease-free survival, health-related quality of life.~      Safety parameters: Vital signs, adverse events (AEs), hematology, blood chemistry,and~     immunoglobulin levels Number of study centers: 4 study centers in Italy T otal number of~     patients, statistical rationale provided: Expected total of 55 patients. The final sample~     size will be based on the number of events observed for the primary efficacy endpoint as~     calculated in the sequential statistical model.~      Adverse events: AEs observed, mentioned upon open questioning and/or spontaneously reported~     will be documented.~      Planned start and end of recruitment: Start of recruitment: 3rd quarter 2006. End of~     recruitment: 1st quarter of 2007~   "
206453|NCT00858988|"~     The purpose of this study is to determine whether rifaximin is effective in the treatment of~     tropical enteropathy in a population of African children at high risk for this disease.~   "
206454|NCT00858975|"~     The purpose of this study is to study the change of tumor size and serum cytokine in the~     patients who received cryotherapy for the renal tumors.~   "
206455|NCT00858962|"~     The main purpose of this protocol is to study the effect of an HIV medication known as~     Raltegravir on Buprenorphine in people who have been receiving the same dose of Buprenorphine~     for at least 3 weeks before study entry. This will be determined by giving Raltegravir along~     with Buprenorphine and by measuring the amount of Raltegravir and Buprenorphine in the blood.~     The investigators will also learn about the effects of Buprenorphine on Raltegravir and about~     the safety of taking these two medications together.~   "
206456|NCT00858949|"~     This is an observational study with the goal of determining the costs of nausea and vomiting~     in ambulatory patients after surgery from the US societal perspective.~   "
206457|NCT00858936|"~     This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form~     of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially~     reduce the damage done to the heart during surgery.~      This study has 2 parts. Part 1 will first test 36 subjects at different doses (amount) of the~     study drug. There will be 6 different groups of 6 subjects each that will receive the study~     drug or a placebo. A placebo is a substance that will be prepared to look like the study drug~     but will contain no active ingredients. In Part 1, five subjects from each group will receive~     study drug (IK-1001) and one will receive a placebo. This first part of this study is also a~     dose (amount) escalation. This means that each group will be receiving a different dose of~     the study drug. The first group will receive the lowest dose, the second group will receive a~     slightly higher dose, and the third group a slightly higher dose until all six groups has~     been tested. You can not choose which group you will be in but prior to starting each new~     dose level, the data (information) from the previous dose level will have been reviewed by a~     group of qualified individuals to determine if it is safe to proceed to the next highest dose~     level.~      Part 2 will expand the study and will treat at least 158 (and up to 632) more subjects at a~     dose level that has been deemed safe from information collected from Part 1. Subjects in Part~     2 of the study will have a 1 in 2 (50%) chance of receiving the study drug or placebo.~     Whether the subject gets study drug or the placebo will be randomly assigned (like the toss~     of a coin).~      The study drug or placebo will be given as an intravenous infusion (into the vein) for six~     hours while the subject is having their CABG surgery.~      The subjects will be followed up for 6 months after their CABG surgery.~   "
206460|NCT00858897|"~     Glutathione is normally present at high (millimolar) levels in blood and plays an important~     role in the body's defense against oxidative stress, that is, against the damage caused to~     the body by reactive oxygen species produced by the metabolism of most nutrients, including~     glucose. Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and~     glycine.~      This study is looking at how blood sugar levels may affect the way glutathione is made and~     used by the body. Since glutathione is continuously synthesized and broken down, the amount~     of glutathione present in blood depends on the balance between its rate of synthesis and its~     rate of use.~      In earlier studies, the investigators found that in poorly controlled diabetic teenagers,~     glutathione was low, not because its production was decreased, but because it was used at an~     excessive rate. In this study, the investigators want to determine how short-term changes in~     blood sugar levels affect glutathione levels. This will help improve our understanding of how~     diabetes affects metabolism.~   "
206461|NCT00858884|"~     The purpose of this study is to determine whether Libman-Sacks endocarditis (inflammation of~     the heart valves) is the cause of neuropsychiatric manifestations (stroke, transient ischemic~     attacks, cognitive dysfunction, seizures, acute confusional state, or psychosis) in patients~     with systemic lupus erythematosus.~      Hypothesis of the study: Libman-Sacks endocarditis (especially valve vegetations or small~     valve growths) generate macro (large) and micro (tiny) emboli that occlude the medium and~     small cerebral vessels resulting in altered perfusion, ischemic brain injury, and major NPSLE~     (stroke, TIA, seizures, cognitive dysfunction, acute confusional state, or psychosis).~   "
206462|NCT00858871|"~     The purpose of this study is to compare the overall survival of brivanib versus sorafenib in~     subjects with advanced HCC who have not received prior systemic therapy.~   "
206463|NCT00858858|"~     This study has two major goals:~        1. To determine the effects of bile salts on causing DNA injury and activating signaling~          pathways that promote growth in cells from the esophagus of patients who have~          gastroesophageal reflux disease (GERD)~        2. To determine whether changes in bile composition induced by treating patients with a~          bile salt called ursodeoxycholic acid (UDCA) can alter DNA injury, signaling pathway~          activation and other types of damage in cells from the esophagus of patients who have~          GERD.~   "
206464|NCT00858845|"~     People with heart failure often have weakness in their leg muscles. This study will determine~     whether the leg weakness is due to very high adrenaline levels and whether the medication~     clonidine can improve leg weakness.~   "
206465|NCT00858832|"~     Endomyometritis is an infection in the uterus. It can occur in up to 1 out of 5 women~     having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean~     delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can~     prolong the woman's stay in the hospital after birth, slow down her recovery time at home,~     and increase medical costs. Methergine is a medication that is routinely used to stop uterine~     hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery.~     Methergine works by contracting (tightening) the uterus. These contractions also help the~     uterus to expel or remove parts of the placenta that increase the chance of developing a~     uterine infection.~      This research study is being done to learn if routine use of Methergine can lower the chances~     of developing a uterine infection after cesarean delivery. Half of the women in this study~     will receive Methergine for a few days during their hospitalization after cesarean delivery.~     The other half of the women will not routinely receive Methergine.~   "
206466|NCT00858819|"~     This is an observational study aiming to study the prevalence and risk factors for~     osteoporosis and vertebral fractures in patients with ankylosing spondylitis attending three~     Rheumatology clinics in Western Sweden.~   "
206467|NCT00858806|"~     Standard therapy with Imatinib (IM) significantly prolongs the survival of Ph+CML patients~     who obtain a complete cytogenetic response (CCgR). Elderly patients (i.e., at least 65 years)~     have similar cytogenetic responses and survival, but they usually show a low compliance. The~     aim of the study is to evaluate the percentage of elderly patients who maintain a CCgR with~     intermittent imatinib therapy with respect to standard daily administration.~   "
206468|NCT00858793|"~     Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If~     sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a~     transplant of autologous CD34+ cells transduced with an antiviral vector (M87o). If~     autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a~     compatible donor is available. To minimize risk of transplant failure, a second unmodified~     CD34+ cell transplant will be given one week after the first transplant.~   "
206469|NCT00858780|"~     This study involves Rheumatoid Arthritis patients in regular clinical setting who are already~     on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is~     intended to identify parameters that can serve as guidance in clinical settings. This study~     will consider the clinical and radiographic course in subjects when etanercept treatment is~     tapered or discontinued, and analyze the subjects' experience of disease worsening and the~     predictive values of clinical parameters, serum biomarkers and imaging on the clinical and~     radiographic course in different treatment groups. The effect of re-treatment with etanercept~     at treatment failure will also be studied.~   "
206470|NCT00858767|"~     Previous studies have indicated that menaquinone-7 (MK-7) is the most effective form of~     vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7, but~     its taste is not appreciated by the Western society. For this reason, the active biological~     compound has been manufactured as enriched oil or casein (≈80% of proteins in cow's~     milk)-enriched powder. However, cow's milk allergy is the most common cause of food allergy~     affecting a minimum of 2-3% of infants. The investigators will therefore compare this~     protein-delivery system to an alternative delivery system (Arabic gum; 98% polysaccharides).~     To compare the difference between powder and oil as MK-7 delivery vehicle, the investigators~     will also test the efficacy of enriched linseed oil.~   "
206471|NCT00858754|"~     This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous~     (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related~     pain and constipation from taking opioids. The length of participation will be up to 7 weeks.~   "
206511|NCT00858234|"~     The clinical study determines recommended clinical dose, and evaluates the safety,~     tolerability, pharmacokinetics and efficacy of MK0683 in combination with bortezomib in~     patients with relapsed and/or refractory multiple myeloma in Japan.~   "
206472|NCT00858741|"~     The aim of the investigators study was to determine whether 8 Gy in a single fraction~     provides equivalent pain and narcotic relief compared to 30 Gy in 10 fractions for patients~     with painful bone metastases.~      The secondary objectives were to evaluate the frequency, duration of pain relief, narcotic~     relief, toxicity and the effect on quality of life measures for each of the two treatment~     arms.~   "
206473|NCT00858728|"~     The immune system undergoes a range of changes as individuals become elderly. These may~     manifest as an increasing susceptibility to infection or a tendency to develop autoimmune or~     malignant disease. Multiple underlying factors contribute to this phenomenon of immunological~     aging, and in this study the investigators will examine the possibility that inadequate diet~     may be one such contributing factor. Fruit and vegetable intake, which can be low in the~     elderly, is associated with reduced chronic disease risk. This proposal will test the~     hypothesis that increased fruit and vegetable intake may positively affect clinically~     relevant measures of immune function. One hundred healthy volunteers aged 65-85 years~     following a low fruit and vegetable diet (<=2 portions/d) will be recruited and randomised to~     continue following their normal diet, or to consume at least 5 portions of fruit and~     vegetables daily for 16 weeks. Immune function and biochemical markers of nutritional status~     will be assessed before and after the intervention period.~   "
206474|NCT00858715|"~     Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous~     intervention with stent implantation. However, response to clopidogrel shows a wide~     interindividual variability and a high on-treatment residual ADP-inducible platelet~     reactivity has already been associated with an increased risk for adverse events after~     coronary stenting. In the present study, platelet reactivity will be determined by 6~     different platelet function tests in patients on dual antiplatelet therapy after angioplasty~     and stenting for peripheral, coronary and carotid artery disease. One hundred patients~     showing high on-treatment residual ADP-inducible platelet reactivity in 2 or more tests will~     be randomized to receive either 75mg or 150mg of daily clopidogrel in addition to aspirin for~     3 months. The aim of the present study is to investigate the effects of intensified~     antithrombotic therapy (150mg clopidogrel + 100mg aspirin daily) versus standard~     antithrombotic therapy (75mg clopidogrel + 100mg aspirin daily) in patients with decreased~     clopidogrel-mediated platelet inhibition after percutaneous intervention with stent~     implantation.~   "
206475|NCT00858702|"~     The purpose of the study is to test the efficacy and safety of the combination of Calcium~     Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class)~     and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not~     adequately controlled with olmesartan medoxomil alone~   "
206476|NCT00858689|"~     Fragile X Syndrome (FXS) is the most common known inherited form of mental impairment,~     developmental disability and autism. Minocycline is an antibiotic that has recently been used~     to treat the mouse model for Fragile X, and was found to reverse the structural abnormalities~     that are seen their brain cells. The purpose of this research study is to determine if~     minocycline is an effective treatment for patients with fragile X syndrome (FXS).~   "
206477|NCT00858676|"~     The objective of this trial is to investigate the effect of early treatment of glucose~     toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of~     cardiovascular events and the inhibition of atherosclerosis.~   "
206478|NCT00858663|"~     The purpose of this study is to determine the best doses of RAD001 (everolimus) tablets and~     cisplatin to give to patients who are receiving radiation therapy for head and neck cancer.~   "
206479|NCT00858650|"~     The primary objective of the Registry of HYpogonadism in MEn (RHYME) is to establish and~     maintain a large, multi-national prospective registry of male patients who have been~     diagnosed with male hypogonadism (HG), also known as androgen deficiency or testosterone~     deficiency.~   "
206480|NCT00858637|"~     The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo~     and non-inferiority with simvastatin in reducing serum low-density lipoprotein~     (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study~     incorporates a Washout Period and two treatment periods - an active comparison phase and a~     placebo-controlled withdrawal phase.~   "
206481|NCT00858624|"~     A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult~     non-smoking population. Chronic cough has many associated complications including~     incontinence, muscular chest pains, blackouts and depression. Current treatment is often~     ineffective in these patients. To develop new medications the investigators need to~     understand more about the mechanisms that can lead to excessive coughing.~      This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic~     cough. The investigators hypothesise that that chronic cough patients have a more sensitive~     cough reflex as a result central nervous system hyper-excitability (central sensitisation).~     The investigators will measure cough reflex sensitivity before and after administration of~     ketamine, a medication that blocks an important receptor in the central nervous system.~   "
206482|NCT00858611|"~     Objectives:~        -  To evaluate the safety and tolerability of a prime-boost study regimen that includes the~          recombinant DNA vaccine followed by licensed 2008/2009 FluLaval(Registered Trademark) in~          adults ages 18-50 years and adults ages 51-70 years as compared with control groups that~          receive the licensed vaccine only.~        -  To evaluate whether the study participants in each age group receiving a prime-boost~          schedule have a greater frequency of H1 or H3 neutralizing antibodies compared with~          those of the same age group who received only the 2008/2009 trivalent influenza vaccine.~        -  To evaluate differences in antibody or T cell responses (quantity, quality, or~          durability) between the two groups.~      Eligibility:~        -  Participants ages 18 to 70 years of age who are available for clinic follow-up through~          Week 24 and who have no previously undiagnosed clinically significant chronic diseases.~          Participants will provide blood samples for further testing to determine eligibility.~          Females must not be or become pregnant during the study.~        -  Volunteers who have been immunized with the current season FDA-approved influenza~          vaccine (2008-2009), or who are being treated for tuberculosis may not participate.~      Design:~        -  The study lasts for 24 weeks.~        -  Week 0: The first day of Week 0 (i.e., Day 0) is defined as the day of enrollment and~          first injection. Specific eligibility is reviewed. Participants will receive an~          injection of either the DNA vaccine VRC-FLUDNA047-00-VP (at 4 mg dosage) or a placebo.~        -  Week 4: All study participants will receive an injection of the trivalent seasonal~          influenza vaccine, according to the manufacturer's package insert directions.~        -  Participants will be given 7-day diary cards on which to record temperature and symptoms~          (e.g., muscle aches, headache, chills, nausea) and injection site reactions (e.g., pain,~          tenderness). Participants may also enter this information via the Internet. Presence of~          symptoms may require additional visits to the clinic.~        -  Participants will return to the clinic 2 weeks after each injection for the following~          procedures:~        -  Blood draws for further tests to determine the immune system's response to the~          vaccine(s) Clinical evaluations: vital signs and weight, examinations of the lymph~          nodes, and targeted physical exam on any visit if indicated by interim complaints or~          laboratory findings.~   "
206486|NCT00858559|"~     Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device~     follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are~     uneventful, revealing no relevant changes related to the implanted device and in the~     patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up~     intervals are frequently used although they are not according to recommendations. This may~     increase the delay in detection of relevant changes in the disease and in deviations from~     optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters~     reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac~     electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet~     platform accessible by the attending physician.~      In the present study, the investigators evaluate safety and efficacy of 12-month follow-up~     intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month~     follow-up scheme.~   "
206487|NCT00858546|"~     The aim of the study is to test the effects of low frequency deep rTMS using the novel H-coil~     on the motor, affective and cognitive deficits in patients with Parkinson's disease (PD) and~     to establish its safety in this population.~      The investigators anticipate to recruit 10 patients to an open pilot study. All patients will~     receive an active rTMS stimulation and will be given 12 treatment sessions, over a period of~     up to 4 weeks. Each of the 12 daily treatment sessions (lasting about 30 minutes each), will~     be consisted of 25 stimulation trains over the prefrontal cortex (20Hz trains, 2 seconds each~     with an inter-train interval of 20 seconds) and one train of 15 minutes at 1 Hz over the the~     motor cortex.~      The following outcome measures will be taken prior to the treatment (screening visit), and at~     day 1, 10, 30, 60, and 90:~        1. Unified Parkinson's Disease Rating Scale (UPDRS )~        2. Clinical Global Impression of Severity (CGIS)~        3. Pegboard test.~        4. Tapping test~        5. Up & Go test~        6. Abnormal Involuntary Movement Scale (AIMS) Mood and affect Beck Depression Inventory~          (BDI) Cognition~      1. Mini mental State examination (MMSE) 2. Digit forward and backward tests. 3. Word fluency.~     4. Frontal Assessment Battery (FAB)~      Side effects will be closely monitored by the researchers and will be promptly reported to~     the IRB~   "
206488|NCT00858533|"~     This pilot study will compare workplace health intervention delivered by advisors based in GP~     practices with normal GP care to assess the usefulness of the concept and its potential for~     wider use in a larger randomised controlled trial.~   "
206489|NCT00858520|"~     A biobank of Serum, plasma, DNA samples together with clinical information including specific~     questionnaires, complete pulmonary function and chest CT-scan, is prospectively collected in~     patients seen at the investigators' clinical service.~      The objective is to study candidate gene pathways in COPD and or lung cancer and to associate~     them with the clinical characteristics and phenotypes of COPD/emphysema and lung cancer.~      In subgroups of well characterised patients, other biological materials are also collected~     (lung tissue biopsies, peripheral blood mononuclear cells).~   "
206490|NCT00858507|"~     The objectives of this study are to test an evidence-based model for improving primary and~     preventive care engagement among homeless Veterans not currently receiving care and to~     demonstrate the additive benefit of primary care-based treatment engagement by this~     population.~   "
206491|NCT00858494|"~     The purpose of this study is to determine if a commercially available homeopathic cold remedy~     for children is effective in providing relief from cold symptoms in children 2-5 years old.~     It is postulated that children will have relief of symptoms after receiving a dose of the~     cold remedy~   "
206492|NCT00858481|"~     A pilot dose ranging study to evaluate the safety and efficacy of different strengths of~     Spinosad Creme versus a vehicle control.~   "
206493|NCT00858468|"~     Primary Objective:~      To describe the safety of the 2004-2005 pediatric formulation of the inactivated,~     split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the~     package insert for vaccine-naïve young children) to the investigational and control groups.~      Observational Objective:~      To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers~     (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the~     investigational and control groups.~   "
206494|NCT00858455|"~     The purpose is to study the effect of Maalox® and One A Day® on the pharmacokinetics of~     GSK1349572, and also to compare the safety of GSK1349572 when administered alone and when~     administered with Maalox® and One A Day®. There are four dosing periods in this study, each~     period requires a 4 night stay. A follow-up visit is also required at approximately 7 days~     after the last dose administration. Starting from the first period to the follow-up, it will~     take about 1 month. Screening visit is required to be completed within 30 days prior to the~     first dose.~      MAALOX® is a registered trademark of Novartic Consumer Health, LLC. ONE A DAY® is a~     registered trademark of Bayer Healthcare LLC.~   "
206495|NCT00858442|"~     Does the addition of Platelet-Rich Plasma (PRP) to release of burn contractures and skin~     graft on the limbs of children with retractable burn sequelae reduce the initial time of the~     compressive treatment and maintain or lower the graft's retraction?~   "
206496|NCT00858429|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. Specialized radiation therapy, such as yttrium Y 90 glass microspheres that~     deliver a high dose of radiation directly to the tumor, may kill more tumor cells and cause~     less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Capecitabine may also make tumor cells more sensitive to radiation~     therapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 glass~     microspheres when given together with capecitabine in treating patients with liver~     cholangiocarcinoma or liver metastases.~   "
206497|NCT00858416|"~     The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion~     and heat on the severity of pain in management of osteoarthritis of the knee~   "
206498|NCT00858403|"~     The main purpose of this study is to learn how patients with Advanced Non-Small Cell Lung~     Cancer (NSCLC) respond to the study drug Dasatinib. The study drug, Dasatinib, has been~     approved by the U.S. Food and Drug Administration (FDA) for treatment of leukemia, but has~     not been approved for the treatment of other kinds of cancer. The use of Dasatinib in this~     study is considered experimental.~   "
206499|NCT00858390|"~     The investigators propose to assess 36 donors' nutritional status using accepted parameters~     (prealbumin, resting energy expenditure); to assess nutrient intestinal absorption through~     13Curacil breath tests; and to evaluate serum concentrations of IL-6 and TNFalpha to~     determine if continuing or initiating enteral feeding and nutritional supplementation is~     effective in restoring or maintaining nutritional parameters.~   "
206500|NCT00858377|"~     This first-in-human study of AMG 900 will be conducted in two parts: dose escalation and dose~     expansion. The dose escalation part of the study is aimed at evaluating the safety,~     tolerability and PK of oral AMG 900 in subjects with advanced solid tumors. Up to 50 subjects~     may be enrolled in dose escalation. The dose expansion part of the study will consist of 42~     subjects in three taxane-resistant tumor types. The dose of AMG 900 will be dependent upon~     data from the dose escalation part of the study~   "
206501|NCT00858364|"~     This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in~     subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the~     treatment of stage IV Non-Small Cell Lung Cancer (NSCLC). Approximately 3000 subjects with~     stage IV NSCLC expecting to receive at least 2 additional cycles (at least 6 total weeks) of~     first line myelosuppressive cyclic chemotherapy will be enrolled into the study. Subjects~     will be randomized in a 2:1 allocation (Group A: darbepoetin alfa 500 µg every 3 weeks <Q3W>,~     Group B: placebo Q3W)~   "
206502|NCT00858351|"~     The purpose of this study is to examine potential treatment options for a condition in~     diabetics that causes tingling, pain, and numbness in the hands and /or feet, also known as~     diabetic peripheral neuropathy.~   "
206503|NCT00858338|"~     This study is to evaluate the efficacy and safety of addition of intraperitoneal (ip)~     Floxuridine to adjuvant chemoradiation therapy for patients under-going potentially curative~     stomach resection.~   "
206504|NCT00858325|"~     The primary objective of this study is to characterise the pharmacokinetics and dose~     proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses~     of daptomycin in healthy Chinese volunteers.~   "
206505|NCT00858312|"~     Obesity is a national epidemic with multiple causes and complex solutions. Research in both~     animals and humans has suggested that the inclusion of dairy foods into a moderate calorie~     restricted diet can increase weight loss and fat loss. Our proposed project extends these~     prior findings by determining, for the first time, how inclusion of dairy in a~     calorie-restricted diet changes the amount of visceral adiposity in overweight and obese~     subjects. The investigators also propose unique studies to evaluate the potential~     mechanism(s) by which dairy promotes weight and fat loss during dieting, through an~     examination of adipocyte size, gene expression, and inflammatory markers. The hypotheses~     under investigation are (1) that inclusion of dairy foods in a modest energy restricted diet~     will significantly increase body fat loss compared to a control diet; (2) that dairy products~     in a modest energy restricted diet will result in greater fat loss from intra-abdominal~     adipose tissue compared to the control, 3) components of dairy products up- or down-regulate~     the secretion of metabolically-relevant hormones during the postprandial and inter-meal~     periods, 4) dairy products will promote satiety and/or satiation, 5) dairy foods reduce~     adipocyte differentiation and/or enhance adipocyte apoptosis, leading to concomitant white~     adipose tissue (WAT) expression changes for genes playing a role in these processes, 6) dairy~     foods will reduce adipocyte lipid storage and enhance pathways associated with thermogenesis~     and mitochondrial function in WAT, as reflected in gene expression changes and reduced~     adipocyte size, and 7) dairy foods included in a modest energy restricted diet will decrease~     inflammation in WAT and other tissues, thus decreasing circulating cytokines, increasing zinc~     status, decreasing expression of inflammatory markers in WAT, and reducing WAT macrophage~     infiltration.~   "
206506|NCT00858299|"~     This study is a multicenter, prospective, interventional study. It does not have a control~     group. All participants will receive 160 mg valsartan for 8 weeks. Among them, the patients~     with persistent proteinuria (defined as proteinuria more than 1 g/g after 8 weeks treatment~     of valsartan) will receive 320 mg valsartan for further 16 weeks. Participants who did not~     receive any ACEI or ARB previously will have a titration period for 4 weeks (80 mg for 4~     weeks, 160 mg for 4 weeks, and then 320 mg for 16 weeks).~      The investigators will evaluate the change of urinary angiotensinogen excretion between at~     baseline, at 8 weeks, and 24 weeks.~   "
206507|NCT00858286|"~     The purpose with this study is to describe in detail the control or lack of control of~     asthma, based on two different dosing strategies, regular treatment with SERETIDE in a stable~     dosing with short acting beta-2 agonists as needed, or maintenance treatment with SYMBICORT~     and using the same inhaler with SYMBICORT as needed.~   "
206508|NCT00858273|"~     Glutathione is normally present at high levels in the blood and plays an important role in~     the body's defense against oxidative stress, that is, against the damage caused to the body~     by several reactive oxygen species produced by the metabolism of most nutrients, including~     glucose. Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and~     glycine.~      This study is looking at how blood sugar levels may affect the way glutathione is made and~     used by the body. Since glutathione is continuously synthesized and broken down, the amount~     of glutathione present in the blood depends on the balance between its rate of synthesis and~     its rate of use.~      In earlier studies, we found that in poorly controlled diabetic teenagers, glutathione was~     low, not because it was not produced fast enough, but because it was used at an excessive~     rate. In this study, we want to find out whether improving blood sugar control will increase~     glutathione levels, and, if so, how long this will take. We also hope to find out if oral~     supplementation with a mixture of several antioxidant vitamins and minerals will increase~     glutathione levels more than taking a placebo.~   "
206509|NCT00858260|"~     Searching for high morbi-mortality risk Klotho variants in dialysis patients~   "
206510|NCT00858247|"~     The prevalence of obesity has reached epidemic proportions nationally as well as~     internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a~     risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to~     vitamin D insufficient. In adults, low vitamin D status appears to be associated with the~     development of type 2 diabetes and metabolic syndrome. There is little information on the~     prevalence of vitamin D insufficiency and its implications in obese adolescents.~     Additionally, it is unknown whether treatment of vitamin D insufficiency in adolescents might~     result in improvement in insulin resistance, lipids and cardiovascular risk markers.~      We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and~     cardiovascular risk in obese adolescents and that vitamin D3 supplementation improves insulin~     resistance and cardiovascular risk factors in this population. The purpose of the study is to~     determine the impact of vitamin D3 supplementation on various parameters of insulin~     secretion, insulin action, lipids and C-reactive protein in obese adolescents.~   "
206555|NCT00857649|"~     The primary objective of this study is to examine the efficacy of memantine on cognition and~     behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.~   "
206512|NCT00858221|"~     The overall goal of this study is to determine whether variations in the perilipin, and~     several other, genes would be a useful tool for physicians who are caring for morbidly obese~     patients to guide therapy.~      The main hypotheses to be tested is that sequence variations (polymorphisms) in the perilipin~     gene and several other obesity-related genes are associated with resistance to weight loss~     for obese individuals on energy restricted diets, potentially playing a role in the~     development of obesity related complications.~   "
206513|NCT00858208|"~     Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular~     degeneration in routine clinical practice at least as good as demonstrated in randomized~     multicenter clinical trials.~   "
206514|NCT00858195|"~     The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.~   "
206515|NCT00858182|"~     A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing~     strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is~     to evaluate the possibility to formulate PD solutions containing xylitol and L-carnitine as~     osmotic agents to partially replace glucose.~   "
206516|NCT00858169|"~     The purpose of this study is to:~        1. To investigate the wrist joint synovial blood flow intensity and model by quantitative~          three-dimensional (3D) power Doppler ultrasonography (PDUS) in patients with rheumatoid~          arthritis before and after initiation of a new medicine and compare these data with~          routinely used clinical data and laboratory findings, such as pain score, erythrocyte~          sedimentation rate (ESR) and C-reactive protein (CRP)~        2. To investigate the intra-observer and inter-observer agreement of quantitative 3D PDUS~          assessment of the vascularity in wrist joints and knee joints using automatic volume~          scan.~   "
206517|NCT00858156|"~     The primary objective of the study is to evaluate the effect of hepatic function on the~     pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic~     impairment and in subjects with normal hepatic function.~   "
206518|NCT00858143|"~     This open-label, national, prospective, observational, non-interventional, multi-center, post~     marketing surveillance study was performed in order to examine the efficacy and safety of~     Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related~     co-morbidities.~   "
206519|NCT00858130|"~     The investigators plan to perform an exploratory study to investigate the effects of~     electro-stimulation of the legs on the symptoms and clinical findings of post thrombotic~     syndrome (PTS), as well as quality of life of patients with PTS. The investigators theorize~     that electro-stimulation will provide both a mechanical benefit via muscular contraction and~     increased venous outflow from the affected extremity, as well as an anesthetic effect, which~     the investigators anticipate will translate into improved symptomatic outcomes, quality of~     life (QOL) benefits.~   "
206520|NCT00858117|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Giving~     alemtuzumab together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with~     rituximab and to see how well it works in treating patients with previously untreated B-cell~     chronic lymphocytic leukemia.~   "
206521|NCT00858104|"~     Thyroid nodule pathologies occur frequently and represent a clinical issue for the~     endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The~     incidence of this pathology has been further highlighted by the introduction of the~     ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is~     now detected through ultrasound. The majority of nodules are benign and characterized by slow~     growth, and therefore treated with suppressive doses of levothyroxine. Long-term~     levothyroxine treatment has, however, several well-known side effects and limitations.~      During the last years, number of controlled studies have demonstrated that ultrasound guided~     percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with~     a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable~     fashion, without side effects.~      Aim of the study:~        1. to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign~          thyroid nodules and on nodule-related symptoms, and to compare these effects with~          findings in control group without active therapy;~        2. to assess the eventual re-occurence of thyroid lesions (observed after other types of~          ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up;~        3. to demonstrate reproducibility of results within different environments and under~          different operators;~        4. to validate eventual presence of major or minor side effects.~      To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up.~     Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina~     Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della~     Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in~     PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.~   "
206522|NCT00858078|"~     Background:~        -  Mutations detected in the BRCA1 or BRCA2 genes have been show to produce very high risks~          of breast and ovarian cancer (as high as 90% and 60%, respectively), as well as~          accompanying risks for several other types of cancer. Women who have these genetic~          anomalies and who do not have cancer are aware of their high-risk status, which can have~          an effect on their ability to make decisions about personal choices and health care.~        -  Researchers are interested in learning more about how people who know their cancer risk~          status make decisions on personal relationships, family formation, and risk-reduction~          options.~      Objectives:~      - To study young women s experiences and decision-making processes regarding family history,~     genetic testing, couple relationships, family formation, and cancer risk management within~     the context of their experiences as BRCA1/2 mutation carriers.~      Eligibility:~        -  Women between the ages of 18 and 35 years of age and older who have been identified as~          having a BRCA1 or BRCA2 mutation. Participants must be contemplating or have experienced~          couple relationships, family formation, and/or risk management and reduction.~        -  Participants must be willing to have their interviews digitally recorded~      Design:~        -  Researchers will conduct between 30 and 50 telephone interviews of study participants.~          Each interview will be approximately 90 minutes in length. The interview consists of~          open-ended questions that ask about the participants and their experiences before,~          during, and after they underwent genetic testing for BRCA1/2.~        -  At least one focus group will be coordinated at a national conference for individuals~          who are aware of their genetically based cancer risk. If more than 25 individuals are~          interested in participating in the group, an additional focus group will be convened.~        -  No medical treatments are specifically offered as a part of this study....~   "
206523|NCT00858065|"~     This study explores whether giving families a choice of family-based prevention programs to~     prevent adolescent alcohol use will make a difference in program recruitment, retention,~     completion, as well as adolescent outcomes. Half of the families are assigned to a~     traditional random control trial condition and half are assigned to a choice condition.~     Further, this effectiveness study is being implemented by Kaiser Permanente Health Care~     system, and explores the issues of implementing such programs within such settings.~   "
206524|NCT00858052|"~     The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT~     in women who are undergoing primary breast augmentation or replacement of existing~     saline-filled or silicone gel-filled augmentation implants.~   "
206525|NCT00858039|"~     Trastuzumab (Herceptin®) increases the chances of cure in patients with Her-2 overexpressing~     early breast cancer. Unfortunately, both the chemotherapy drugs used in this setting~     (anthracyclines) and trastuzumab are known to cause cardiac dysfunction in a proportion of~     patients. Patients who develop heart problems when taking trastuzumab might have to stop this~     treatment, which could jeopardise their chances of cure. N-terminal pro-B-type natriuretic~     peptide (NT pro-BNP) is a cardiac biomarker that is measured in the blood, the levels of~     which have been shown to indicate the presence of heart failure. Some early research has~     suggested that there may be a correlation between elevated NT pro-BNP and heart damage due to~     cancer chemotherapy and also trastuzumab. Troponin is another substance measured in the blood~     that can indicate heart damage. Finally, certain variations in an individual's genetic makeup~     (called polymorphisms) could put them at increased risk of heart damage from trastuzumab.~     Here we are studying whether any of these factors (NT pro-BNP levels, troponin levels, or~     certain genetic polymorphisms) can accurately predict who is at highest risk of~     trastuzumab-related cardiotoxicity.~      The principal aim of this study is to evaluate the utility of NT pro-BNP as a predictive~     biomarker for the development of trastuzumab related cardiotoxicity (TRC). The investigators~     will also examine if single nucleotide polymorphisms in the HER2 gene or Fc-gamma-receptor~     genes predict for TRC.~   "
206526|NCT00858026|"~     When mothers wanted to shift from breast milk to infant formulae, babies were randomly~     assigned to receive a fermented or a standard formula. Biological and clinical investigations~     were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of~     study formula. Intestinal microbiota was assessed by using culture-dependent techniques.~   "
206527|NCT00858013|"~     This multi-center, randomized controlled study aims to evaluate the durability and efficacy~     of nateglinide therapy for long term glycemic control compared with glimepiride.~   "
206528|NCT00858000|"~     Hepatocellular carcinoma is an aggressive disease with limited therapeutic options.~     Therefore, new approaches to treat this type of cancer are needed with immunotherapy~     potentially being one of these. As a first step in the development of novel therapies,~     expression analysis of specific markers, including tumor antigens will be carried out. This~     will be done retrospectively using available hepatocellular carcinoma tissue samples.~   "
206529|NCT00857987|"~     Evaluate the improvement of the common cold with the use of medication~   "
206530|NCT00857974|"~     The physical function of older candidates for renal transplantation and their ability to~     sustain physical activity programs are currently unknown. The primary goal of this study is~     to determine the feasibility of a physical activity intervention in older dialysis-dependent~     patients, assessing its effect on maintaining transplant candidacy and outcome after~     transplantation. Clinical practice guidelines do not set an absolute age limit for evaluating~     potential renal transplant candidates. While cardiovascular risk assessment and malignancy~     screening are emphasized in the older age group, physical performance and the risk for~     disability are often overlooked. Although healthy older patients experience increased life~     expectancy after renal transplantation versus remaining on dialysis, outcomes such as the~     capacity to live independently and function well have not been studied. Given the poorer~     baseline health status in aging end-stage renal disease patients, rapid changes in health on~     dialysis, and the national organ shortage, it is increasingly important to identify factors~     that predict better outcomes and devise strategies that will maximize the benefit of~     transplantation in older individuals.~      The investigators hypothesize that muscle is the principal organ system underlying impaired~     physical function among older transplant candidates, and that decreased muscle mass and~     physical functioning lead to poorer outcomes in older renal transplant candidates. The~     investigators propose that a simple bedside performance measurement of lower extremity~     functional limitations, the Short Physical Performance Battery, will be a strong predictor of~     outcomes in this patient cohort. The investigators also propose that outcomes can be improved~     with exercise training, potentially leading to longer durations of active transplant~     candidacy and greater independence after successful transplantation. The Specific Aims of~     this research are:~        1. Determine the feasibility of an exercise intervention in dialysis-dependent wait-listed~          patients age 60 years and over who will be randomized to one of two groups: usual care~          versus a structured physical activity program.~        2. Define the natural history of physical function in patients age 60 years and greater who~          remain on dialysis or undergo renal transplantation attempting to identify a subgroup of~          older wait listed patients who are at high risk for developing disability.~   "
206531|NCT00857961|"~     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.~     Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study~     will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also~     assess safety of the product.~   "
206532|NCT00857948|"~     This is a Phase 2 single center study designed to compare the safety, local tolerability, and~     efficacy of 3 strengths of ivermectin treatment conditioner to placebo.~   "
206533|NCT00857935|"~     A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse~     in subjects with Pediculosis Capitis~   "
206534|NCT00857922|"~     In order to expand neuroscience research and move laboratory advances to patients, there is a~     need to integrate reliable clinical data with biologic information from patient tissue~     specimens. The Neuroscience Research Repository (NRR) seeks to meet this need. The NRR is a~     prospective database and sample bank created to collect information and samples for current~     and future neuroscience research. The objective of this NRR is to develop a data and sample~     repository for study of neurological conditions. A repository utilizing standardized~     electronic health data and samples collected in a uniform manner serves to foster the ability~     to perform research on current and future projects. Samples and data for clinical, genomic~     and proteomic analysis will be provided to optimize their value for neuroscience research.~      The NRR will enroll patients and collect clinically recorded longitudinal data for as long as~     they are followed by the Neurosurgery service and up to an additional 5 years after being~     released from care. Patients will be enrolled on admission to the service and samples will be~     taken at three time points: Time One, within 24 hours of event (preferably first blood draw);~     Time Two, within 48 hours of event; and Time Three, time of any residual tissue availability.~     Family members of select groups of patients will also be approached for enrollment.~      Samples and data will be labeled with a study code to maintain confidentiality. Samples and~     data will be maintained in secure, limited access environments with back-up/redundancy~     procedures in place. Sample inventory will be maintained with a bar-coding system. A duty to~     warn clause will be included in the consent as will the determination of willingness to be~     re-contacted for future research. Time of sample acquisition to time of sample processing~     will be documented for quality control purposes. Freezers will be monitored for temperature~     stability. Recipient investigators will be requested to provide feedback on sample quality.~     Samples will be distributed to neuroscience investigators after approval from the~     Neurosurgery Scientific Review Committee - Dissemination Review Committee and the Committee~     for the Protection of Human Subjects (CPHS).~   "
206535|NCT00857909|"~     This study will investigate whether retaining potassium in the body will lead to changes in~     blood pressure and changes in blood and urine samples.~   "
206536|NCT00857896|"~     The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of~     fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive~     bladder.~   "
206537|NCT00857883|"~     This is a first-time-in-human study. The overall purpose of the study is to assess whether~     the drug is safe and well tolerated after single, increasing doses. The blood levels of the~     drug after different doses will be measured and the effect of the drug on pleasurable eating~     behaviour will be assessed.~   "
210983|NCT00799032|"~     To evaluate the short-term and mid-term safety and efficacy of the Catania coronary stent for~     the treatment of up to two de novo lesions in native coronary arteries.~   "
206538|NCT00857870|"~     Comparison of efficacy and safety of glargine insulin and metformin as first line drug of~     patients insufficiently treated with lifestyle intervention. So far treatment also algorithm~     with lifestyle and metformin has not been evaluated in patients with type 2 diabetes and~     HbA1C greater or equal 7 % and lower than 8.1%.Besides HbA1C postprandial glucose excursion~     and glycemic variability as determinants of oxidative stress will be measured by continuous~     glucose measurement(CGM). Further more CGM will reveal risk of hypoglycemia at night. As~     secondary objectives effect on endothelial function, renal function and biomarkers of low~     great inflammation will be evaluated. So far only scarce information on face to face~     comparison in ealy diabetes exists.~   "
206539|NCT00857857|"~     The study will measure the early and late asthamtic response using an allergen challenge.~     This study will evaluate the safety and patients tolerance to repeat inhaled doses of~     GW870086X using a number of clinical and biological markers.~   "
206540|NCT00857844|"~     The purpose of this study is to determine the relationship between genomic variants of~     components of the renin-angiotensin system and the development of kidney problems due to~     Calcineurin-inhibitors post liver transplant.Also the investigator will evaluate the~     relationship between chronic renal failure post liver transplant and the risk of death. A~     sample of blood and urine wil be examined to see how the patient's genes are arranged in~     order to determine the difference in genes between people which may explain who will develop~     chronic renal failure after having received a liver transplant.~      The results may help us classify patients according to their risk and allow us to target~     their treatment to their individual need. In addition, it may ultimately lead to treatments~     that slows or prevents the development of chronic rejection.~   "
206541|NCT00857831|"~     Vitamin D aids in the body's ability to absorb calcium, it is a vital component in bone~     formation and break down. Reduced levels of vitamin D can indicate a vitamin deficiency and~     may depress serum calcium levels. The following is a list of common causes of vitamin D~     deficiency: lack of dairy products, alcohol usage, elderly, lack of exposure to sunlight,~     individuals with reduced mobility, GI malabsorption problems, dark complexion, severe liver~     damage, and renal failure. Many of these factors can be found in individuals with spinal cord~     injury. SCI results in disuse bone loss after acute injury, which continues with duration of~     injury. The goal of this study is to determine the effects of vitamin D and calcium~     supplements on calcium metabolism and vitamin D deficiency in individuals undergoing~     functional electrical stimulation (FES) stand retraining (SRT).~   "
206542|NCT00857818|"~     The purpose of this study was to determine whether patients with schizophrenia,~     schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a~     larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with~     aripiprazole than with their current atypical antipsychotic treatment (olanzapine,~     risperidone, or quetiapine).~   "
206543|NCT00857805|"~     Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of~     the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency~     ablation (RFA), percutaneous ethanol injection and proton beam radiation (PBR). The goals of~     these treatments are to control tumor growth, to downstage tumor size to meet Milan criteria,~     and to improve survival. Patients who exceed the Milan criteria benefit from tumor~     downstaging as a result of treatment. Patients who meet Milan criteria benefit from tumor~     control to bridge them to liver transplantation. TACE is considered the most common~     locoregional treatment that is used to treat hepatocellular carcinoma (HCC). Proton beam~     radiotherapy has been used in treating HCC in a few centers across the globe. Phase I and II~     trials showed a satisfactory safety and efficacy results. Loma Linda University Medical~     Center is one of these pioneering centers that use proton beam as a treatment for HCC. This~     is the first randomized trial in the medical field that will compare head-to-head the~     efficacy of TACE versus proton beam in treating HCC patients.~   "
206544|NCT00857792|"~     The investigators goals are:~        1. to develop software for quantitative volumetric analysis of myocardial perfusion from~          MDCT images~        2. to test its ability to accurately determine the presence, location, extend and severity~          of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and~          MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns~        3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging~          in combination with the new vasodilator stress agent Regadenoson.~   "
206545|NCT00857779|"~     The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking~     factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ~   "
206546|NCT00857766|"~     The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary~     Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure~     associated with risk of heart disease.~   "
206547|NCT00857753|"~     Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch~     transdermal delivery system.~   "
206548|NCT00857740|"~     The purpose of this study is to investigate whether education about the neurophysiology of~     pain is able to improve central pain inhibition in patients with Fibromyalgia.~   "
206549|NCT00857727|"~     Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population~     undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine~     versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical~     population.~   "
206550|NCT00857714|"~     The purpose of this study is to establish the utility of lapatinib in the treatment of DCIS,~     particularly ER-negative DCIS.~   "
206551|NCT00857701|"~     The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for~     knee flexion contracture following a total knee arthroplasty.~   "
206552|NCT00857688|"~     To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin~     sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing the~     signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years.~   "
206553|NCT00857675|"~     The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in~     treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.~   "
206554|NCT00857662|"~     Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined~     as an AVM size reduction greater than 50%~   "
206556|NCT00857636|"~     The long-term goal of this study is to build a sustainable,community-based outreach program~     using Korean American community health workers (CHWs) to promote breast and cervical~     screening among Korean American women, thereby reducing related morbidity and mortality. The~     study is designed to determine the effectiveness of a health literacy-focused tailored breast~     and cervical cancer control intervention delivered by CHWs.~      The investigators hypothesized that, compared to KA women in the delayed intervention group,~     KA women who receive a health literacy-focused CHW intervention will demonstrate: (1) higher~     levels of adherence to screening for breast and cervical cancer, (2) greater levels of health~     literacy, (3) higher levels of breast and cervical cancer knowledge, and (4) improve~     decisional balance.~   "
206557|NCT00857623|"~     The purpose of this study is to investigate if AZD2066 can relieve the pain arising from~     painful diabetic neuropathy compared to placebo.~   "
206558|NCT00857610|"~     Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human~     skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis,~     including erythema and scaling. The reseachers intend to investigate the dose, frequency of~     use, and time dependence of topical retinol-induced dermatitis. The researchers intend to~     evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid~     responsive genes that control retinoid metabolism and serve as markers for retinoid~     bioactivity. The researchers will also investigate the role of EGF receptor pathway in~     retinoid-induced dermatitis.~   "
206559|NCT00857597|"~     The study objective is to evaluate the relative merits, safety and effectiveness of Transoral~     Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump~     Inhibitors (PPIs).~   "
206560|NCT00857584|"~     Prospective, open-label, controlled (active comparator), randomized study of 8 weeks~     follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR)~     versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at~     stable and clinically therapeutic blood levels) in the treatment of the adult bipolar~     depression. This multicentric study will be featured in two sites in Spain.~   "
206561|NCT00857571|"~     The study compares the plasma concentrations of PF-02413873 after administration of several~     doses as suspension and as tablets~   "
206562|NCT00857558|"~     A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to~     investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes~   "
206563|NCT00857545|"~     This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work~     compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian~     tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still~     be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in~     different ways and stop tumor cells from growing. Vaccines may help the body build an~     effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more~     effective with or without vaccine therapy in treating patients with ovarian epithelial~     cancer, fallopian tube cancer, or peritoneal cancer.~   "
206564|NCT00857532|"~     The primary aim of this study is to compare regional amyloid burden in Parkinson's disease~     (PD) to normal control subjects. We hypothesize that there will be significant differences in~     overall amyloid burden in PD patients compared to age-matched normal controls.~   "
206565|NCT00857519|"~     Over the past 15 years, intravenous chemotherapy has become the most popular conservative~     (eye-saving) method for retinoblastoma treatment because it is often effective and usually~     safe. In recent years, there has been much interest in providing highly focused (focal)~     chemotherapy to a diseased organ including the liver, brain, and eye. With focused~     chemotherapy, the chemotherapy drugs are injected directly into the ophthalmic artery (the~     artery that supplies blood to the eye). A benefit of focal chemotherapy delivery is that it~     decreases the chance of toxicity to other organs such as bone marrow suppression (causing low~     blood counts) and the development of other cancers in the future.~   "
206566|NCT00857506|"~     The primary objective of this protocol is to determine if brain amyloid imaged with~     florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment~     during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and~     Alzheimer's disease.~      Hypothesis 1: The probability a subject will experience progressive cognitive impairment~     within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated~     amyloid positive compared to subjects whose PET scan was rated amyloid negative.~      The secondary objective is to determine the stability, over 36 months of a clinical~     diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET.~      Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated~     as amyloid positive.~   "
206567|NCT00857493|"~     A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate Safety and~     Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old~     Vaccinia-Experienced Subjects~   "
206568|NCT00857480|"~     A study in healthy volunteers to determine whether different drugs metabolised by the liver~     have any effects on how NRL972 is processed within the body.~   "
206569|NCT00857467|"~     This is a healthy volunteer three-way crossover study. A total of 12 subjects will receive~     three single administrations of 1 g rectal suppositories (containing either 5 mg NRL001, 10~     mg NRL001 or matching placebo), with a washout period of at least 7 days between dosings. A~     further 12 subjects will receive three single administrations of 2 g rectal suppositories~     (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), again with a 7 day washout~     period between dosings. The pharmacodynamic response, pharmacokinetics and safety profile~     will be determined.~   "
206570|NCT00857454|"~     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.~     Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study~     will assess the occurrence of skin safety events for a further two months of continuous use~     of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08~     (NCT00702650) trial.~   "
206604|NCT00856999|"~     The purpose of this study is to see if consistent treatment with Botox will lead to longer~     lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug~     Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this~     study a different dosing schedule of Botox injections will be used to see if the effects of~     the Botox treatment last longer than the effects of the standard injection regimen.~   "
206571|NCT00857441|"~     The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes~     of:~        1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in~          comparison to dilation with a standard balloon prior to the implant of the Liberty Bare~          Metal Stent in bifurcation lesions (with side branch involvement).~        2. Comparison of the results above with the results of using a standard balloon prior to~          provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.~   "
206572|NCT00857428|"~     The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone~     hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone~     hydrochloride tablets.~   "
206573|NCT00857415|"~     The study is designed to test the relationship between measurements of brain amyloid using~     florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at~     autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).~   "
206574|NCT00857402|"~     The purpose of this study was to investigate if adjuvant treatment with arginine (the~     substrate for nitric oxide production) rich food supplements could improve clinical outcome~     in patients with smear positive tuberculosis by affecting nitric oxide production.~   "
206575|NCT00857389|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine,~     when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical~     (bone marrow) stem cell transplantation can help to control cancers of the bone marrow and~     lymph node system. The safety of this treatment will also be studied.~      This is an investigational study. Thiotepa and clofarabine are FDA approved and commercially~     available for the treatment of leukemia. Busulfan is FDA approved and commercially available~     for use in stem cell transplantation. The combination of thiotepa, clofarabine, and busulfan~     together with a stem cell transplant is investigational.~      Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.~   "
206576|NCT00857376|"~     Heart disease is the most common cause of death in the United States and it is commonly found~     in people with diabetes and high cholesterol. Inflammation is one mechanism by which diabetes~     and elevated cholesterol damage blood vessels. Inflammation can be increased by oxidative~     stress. This study will see if Alpha Lipoic acid, a potent antioxidant and over the counter~     product, reduces blood levels of markers of oxidative stress and inflammation when compared~     with placebo. Placebo is a substance that looks like the real product, but contains no active~     product.~   "
206577|NCT00857363|"~     The protocol described herein is designed to provide clinical evidence of the substantial~     equivalence of SmartPill GI Monitoring System (SP) to the Sitzmarks (Konsyl Pharmaceuticals,~     Easton, MD) radio-opaque markers (ROM). The trial will enroll symptomatic subjects who meet~     Rome III criteria (1) for chronic functional constipation.~   "
206578|NCT00857350|"~     HIV drug resistance presents a significant public heath problem. This proposal is designed to~     explore the association between ongoing illicit drug use and the prevalence of HIV drug~     resistance among HIV+ opioid dependent patients receiving opioid agonist treatment with the~     following hypotheses:~        1. Hypothesis 1: The prevalence of HIV drug resistance will range between 10% and 30%.~        2. Hypothesis 2: Patients with evidence of ongoing illicit drug use will be more likely to~          have HIV drug resistance.~   "
206579|NCT00857324|"~     The purpose of this study is to determine whether the association of ZMP is safe and provides~     benefits in patients with relapsed/refractory MM.~   "
206580|NCT00857311|"~     A Study to assess the general safety and tolerability of the administration of a 3-dose~     prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis~     C virus infection.~   "
206581|NCT00857298|"~     Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with~     Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced~     weight loss. The investigators hypothesize that health markers will improve in both groups~     but that the improvement will be blunted in the women with HIV-MS.~   "
206582|NCT00857285|"~     The purpose of this study is to determine the efficacy and safety of oral administration of~     olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.~   "
206583|NCT00857272|"~     To compare the safety and efficacy of 2 different bowel cleansing preparations prior to~     colonoscopy in adult subjects.~   "
206584|NCT00857259|"~     The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination~     with Lucentis in patients with neo-vascular age related macular degeneration (AMD)~   "
206585|NCT00857246|"~     This study intends to evaluate the feasibility and treatment efficacy of adding an antibody~     blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven~     efficacy developed at New York University.~   "
206586|NCT00857233|"~     The primary objective of the study was to examine the safety and tolerability of memantine in~     outpatients with moderate to severe Alzheimer's Disease.~   "
206587|NCT00857220|"~     A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age,~     inclusive) and adolescents (12 17 years of age, inclusive) with attention~     deficit/hyperactivity disorder (ADHD) associated insomnia.~   "
206588|NCT00857207|"~     Enhanced Goal Management Training (GMT) is a 10-week group or individual therapy that teaches~     strategies to improve an individual's ability to complete everyday tasks. This research study~     will test the effect of GMT on 36 OEF/OIF Veterans compared to a control group of 16 OEF/OIF~     Veterans receiving a Brain Health Workshop. The results will provide information to conduct~     future research with a larger group of patients or to identify which patients demonstrate~     more benefit from the training.~   "
206603|NCT00857012|"~     Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront~     or following two to three years of tamoxifen treatment (switch) for at least three and not~     more than six months prior to offering an individual participation in this program. Treatment~     should follow local therapy guidelines and standard practice. Treatment decisions for~     patients participating in this study including assessments or supportive therapy during~     follow-up visits will also follow guidelines and remain independent of the program.~   "
208336|NCT00834041|"~     This first open-label study in a pediatric population was designed to evaluate aliskiren~     safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with~     hypertension.~   "
206589|NCT00857194|"~     Coronary heart disease (CHD) is a leading cause of death in the spinal cord injured (SCI)~     population, occurring at younger ages than in the able-bodied population. Conventional risk~     factors for CHD include high concentrations of low-density lipoprotein (LDL), low~     concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), smoking history,~     and family history. Other factors that may influence progression of CHD include C-reactive~     protein (an inflammatory marker), and fibrinogen (a pro-coagulant marker). Individuals with~     SCI with longer duration and greater completeness of injury are more likely to have~     significantly worse carbohydrate tolerance compared to other neurological deficit subgroups.~     Muscle atrophy after SCI is associated with increased insulin resistance. Prolonged~     inactivity has been shown to be associated with hyperinsulinemia and impaired glucose~     tolerance. Body composition changes after SCI to indicate significantly more total body fat~     mass and percent fat and less lean mass compared to able-bodied individuals. Carotid~     intima-media thickness is correlated with atherosclerosis progression and abdominal~     adiposity. Individuals with abdominal adiposity are at a higher risk for CHD, DM,~     hypertension, insulin resistance, and dyslipidemia. Abdominal adiposity and insulin~     resistance are contributors to postprandial lipemia, which may be a more sensitive indicator~     of CHD risk and progression.~      The purpose of this study is to determine the prevalence of conventional risk factors by~     assessing the 10-year risk for CHD, and identify emerging risk factors for CHD in the spinal~     cord injured population. Subjects will have the option to participate in a high fat meal test~     to determine postprandial lipemic responses. Knowledge of this information may be able to~     detect and prevent future cardiovascular events related to CHD.~   "
206590|NCT00857181|"~     The aim of this study is to test whether the oscillation of cytokine concentrations in serum~     is able to predict the development of infection in patients with liver cirrhosis.~   "
206591|NCT00857168|"~     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.~      Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study~     will evaluate the impact of application of antiperspirant and deodorant on absorption of~     testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).~      The study also aim to evaluate the impact of washing the application site on the absorption~     of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous~     solution).~   "
206592|NCT00857155|"~     Purpose: In patients with coronary artery disease, aspirin and Plavix are used increasingly~     to prevent the formation of blood clots in the coronary arteries. These drugs exert their~     beneficial effects by irreversibly blocking platelets, the compounds found in blood~     responsible for clotting after an injury or during a heart attack. However, these effects~     also place patients at increased risk for bleeding after coronary artery bypass surgery.~     Therefore, it is currently recommended to withhold Plavix therapy for 5 days before~     undergoing surgery in order to reduce the incidence of bleeding. However, it has been~     repeatedly shown that Plavix exerts variable effects on different patients, which may be~     partially explained by poor absorption, drug-drug interaction, and by variations in~     deoxyribonucleic acid (DNA) which constitutes your genes. In addition, the time required for~     platelets to regain function after Plavix treatment has been shown to vary between patients.~     Therefore, by measuring platelet function, it may be possible to determine the optimal amount~     of time required to withhold Plavix before undergoing bypass surgery, which may improve rates~     of bleeding following the procedure. The purpose of this study is to classify patients into~     groups based on platelet function in order to define the ideal time period for delaying~     surgery. By analyzing the amount of time required for platelet recovery, it is expected that~     surgery-related bleeding will decrease without increasing the risk of blood clot formation.~      Eligibility: Approximately 200 patients requiring CABG will be enrolled at Sinai Hospital,~     which is the only site where this study is being conducted.~      To be eligible you must:~        -  Be able to provide written informed consent.~        -  Be between the ages of 18-85 and require CABG.~        -  Currently be on aspirin therapy (81-325mg).~   "
206593|NCT00857142|"~     The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone~     hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone~     hydrochloride tablets.~   "
206594|NCT00857129|"~     Prospective evaluation of birth complication in three differently staffed and equipped units~     in the same hospital.~   "
206595|NCT00857116|"~     The purpose of this study is to investigate whether treatment against intestinal helminths in~     patients with pulmonary tuberculosis undergoing chemotherapy could improve the clinical~     outcome by enhancing host immunity.~   "
206596|NCT00857103|"~     This interdisciplinary international research collaboration will test effects of Choice, a~     computer-assisted, interactive support system designed to help cancer patients communicate~     their symptoms and preferences, and clinicians in incorporating this information into patient~     care. In this pretest-post test clinical trial with 200 leukemia and lymphoma patients we~     will: 1) Test effects of Choice when integrated into routine clinical practice on:~     patient-provider communication, documented patient care, anxiety and patient satisfaction; 2)~     analyze relationships among the above variables and explore differences in these~     relationships between groups; 3) analyze group differences in communication style in terms of~     instrumental and affective behavior, content, participation, initiative and person addressed;~     and 4) investigate the extent of the time requirements when using Choice in clinical~     practice, perceived usefulness and ease of use.~   "
206597|NCT00857090|"~     The objectives of the study are to assess the systemic exposure, safety and efficacy of three~     concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper~     urinary tract stones.~   "
206598|NCT00857077|"~     Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron~     supplementation delivered through Expanded Programme on Immunisation vaccination clinics.~   "
206599|NCT00857064|"~     Non-interventional study aiming to provide data on the subjective effects of antipsychotic~     medication assessing subjective well-being and global functioning of patients with~     Schizophrenia under antipsychotic medication. Moreover it aims to assess their adherence to~     the treatment and will investigate whether there is any correlation of these factors with the~     clinical condition of these patients.~   "
206600|NCT00857051|"~     We are conducting a study to look interventions that may reduce stress in the postpartum~     period for first- time mothers. One of these interventions is an educational film that~     describes the common stressors that first-time parents go through in the early postpartum~     period. The other is a hotline service that women can call at anytime during the first 3~     months postpartum to ask about problems she or the baby may be experiencing.~   "
206601|NCT00857038|"~     COPD is a progressive pulmonary disease that is characterized by an inflammatory process in~     the airways and the lungs which leads to progressive airway obstruction. The inflammation is~     associated with tissue loss and remodelling. The investigators hypothesized that doxycycline~     reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators~     will conduct a randomized trial of doxycycline in 30 patients.~   "
206602|NCT00857025|"~     RATIONALE: Biological therapies, such as beta-glucan, may stimulate the immune system in~     different ways and stop tumor cells from growing.~      PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan in~     treating patients with locally advanced or metastatic non-small cell lung cancer.~   "
222515|NCT00646165|"~     To determine the dose and duration of treatment for the best overall response with Forodesine~     in relapsed B-cell chronic lymphocytic leukemia~   "
206605|NCT00856986|"~     This trial is conducted in Europe and North America. The aim of this clinical trial is to~     assess and compare the effect of insulin detemir in combination with liraglutide and~     metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will~     continue their own pre-trial metformin treatment during the trial.~   "
206606|NCT00856973|"~     A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared~     to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age,~     inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.~   "
206607|NCT00856960|"~     This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH~     clearance, PC MRA and ASL MRI methodologies.~   "
206608|NCT00856947|"~     The aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by~     supplementation with high dose vitamin D to the mother during pregnancy. Participants are~     mothers and children of the ABC (Asthma Begins in Childhood) cohort. Mothers are recruited~     during pregnancy and receive daily supplement with 2400 IU of Vitamin D3 or placebo from week~     24 og gestation to 1 week after delivery. In addition all mothers are advised to take the~     recommended dose of 400 IU vitamin D daily. The mothers in ABC also participate in an~     interventional trial with fish oil supplementation, and the vitamin D randomization is~     stratified by fish oil treatment group. The child is followed with acute and planned vits at~     the research unit, and wheeze is diagnosed according to predefined algorithms.~   "
206609|NCT00856934|"~     This prospective randomized trial evaluated the impact of autologous keratinocytes suspended~     in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that~     the treatment would speed and improve wound healing.~   "
206610|NCT00856921|"~     The AAAS gene has been known to cause achalasia, alacrima, adrenal abnormalities and a~     progressive neurological syndrome. A considerable proportion of achalasia patients have been~     known to show alacrima (decreased secretion of tears). However, the genetic mechanism between~     achalasia and alacrima has not been defined yet. The investigators postulated that some~     proportions of early-onset achalasia could be correlated with AAAS gene; thus, the~     investigators aimed to investigate the relationship between the AAAS gene and early-onset~     achalasia.~   "
206611|NCT00856908|"~     The purpose of this study is to assess the 1 month safety and tolerability after multiple~     oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin~   "
206612|NCT00856895|"~     The purpose of study is to measure the quality of life (QOL) of patients pre and post kidney~     transplant by asking them to fill out a survey. Patients will be asked to fill out the survey~     before transplant, 3 months post-transplant, and 1 year post-transplant to see how the~     transplant relates to any progression in quality of life.~      QOL will be assessed to correlate the quality of life and aspects of renal function~     prospectively at pre and post-transplant across all ethnicities and variances of donor types~     at three time points. First, there will be a prospective assessment of QOL in the Hispanic~     and Non-Hispanic kidney recipients before and after transplant at NMH and Colombiana de~     Transplantes. Second, there will be an assessment of the Hispanic kidney patients that have~     been transplanted over the last 10 years at NMH and Colombiana de Transplantes, in a~     cross-sectional fashion. Third, there will be a comparison and determination of the~     differences in QOL in the Hispanic population before and after the Hispanic Transplant~     program was initiated in November 2006. Lastly, there will be an assessment of the social~     impact of the services that NMH's Hispanic Transplant Program provides to patients.~      The questionnaires completed by the subjects at NMH will be the same questionnaires completed~     by the subjects in Colombia. The data obtained from Colombiana de Transplantes will be~     de-identified data and provided to us via a password protected excel file delivered to the~     principal investigator electronically.~   "
206613|NCT00856882|"~     The investigators propose to perform a double-blind, randomized placebo-controlled trial to~     examine the hypothesis that soy protein with isoflavones could improve glycemic control,~     insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with~     prediabetes.~   "
206614|NCT00856869|"~     The study was conducted to describe and compare the plasma pharmacokinetics of NRL972~     administered after a standard meal and while fasted in patients with hepatic cirrhosis~     (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and elderly healthy males, and young and~     elderly healthy females, to assess the effects of liver dysfunction, gender, age and prandial~     intestinal hyperaemia on the clearance of NRL972. In addition, the study was to provide~     information on the safety and tolerability of repeated intravenous doses of NRL972 in these~     populations.~   "
206615|NCT00856856|"~     The purpose of this study is to assess the safety and performance of the BVS Everolimus~     Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de~     novo native coronary artery lesions located in two different major epicardial vessels.~      Currently in development at Abbott Vascular. Not available for sale in the United States.~   "
206616|NCT00856843|"~     To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before~     colonoscopic examination in adult subjects.~   "
206617|NCT00856830|"~     Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of~     lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two~     thirds of new cases and is generally considered sensitive to chemotherapy, despite a median~     time to progression of 4 months. SCLC is one of the most aggressive and lethal types of~     cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with~     extensive disease. Overall, the majority of patients with SCLC die in less than 2 years~     (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for~     patients with extensive disease. The regimen of etoposide in combination with a platinum~     (cisplatin or carboplatin) is generally considered the standard of care although a recent~     Phase III trial suggests improved survival with the combination of cisplatin/irinotecan.~     Further evaluation of new agents in combination regimens attempting to overcome the intrinsic~     drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and~     achieve palliation of disease-related symptoms.~   "
206618|NCT00856817|"~     The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate~     treatment is of influence on adenosine induced vasodilation in healthy individuals.~   "
223642|NCT00631306|"~     This study is being done to determine if the use of double strength cranberry juice in daily~     diet will improve endothelial function.~   "
206619|NCT00856804|"~     INDICATION:~      Patients with chronic hepatitis C, genotype 1 and non-responders to standard treatment for~     hepatitis C.~      OBJECTIVES:~        1. ascertain the rate of sustained response in patients with hepatitis C, genotype 1 with~          peginterferon + ribavirin resistance.~        2. To know the response rate in 12 weeks~        3. Describe the tolerance and safety of thalidomide in combination with peginterferon and~          ribavirin.~      DESIGN OF TEST Pilot Study:~      The single arm study will:~      1. Thalidomide 200 mg and peg-interferon alfa 2b (based on weight: 50-120 mcg / week) +~     ribavirin (based on weight: 1000-1200mg / day)~      Be tracked for 24 weeks after treatment.~      Suspended treatment of 12 weeks in patients who have failed a drop of HCV RNA> 2 log.~      Patients who have been suspended for any reason, the treatment will be followed during 24~     weeks, to assess safety parameters.~      SUBJECT NUMBER: 10~   "
206620|NCT00856791|"~     ON 01910.Na has undergone preclinical and clinical phase I studies showing activity in~     patients with progressing ovarian cancer resistant to platinum-based chemotherapies. This~     study will look at a larger population of patients to determine whether treatment with ON~     01910.Na has an effect on progression free survival rates in patients with platinum-resistant~     ovarian cancer. ON 01910.Na will be given as an intravenous infusion over 2 hours on days 1,~     4, 8, 11, 15, and 18 of a 28-day cycle. Patients will be treated for 6 or more cycles.~   "
206621|NCT00856778|"~     This study is a multi-center, global study that will assess the effectiveness and patient~     satisfaction of the male incontinence sling 12 months after implant as well as the safety~     profile of the product.~   "
206622|NCT00856765|"~     The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may~     benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent~     combination without impairing the process of normal vascular healing and endothelial~     function.~      The goals of this study are:~        1. To compare 6-month angiographic outcome after primary angioplasty using drug eluting~          balloon/bare metal stent combination versus drug eluting stent versus bare metal stent.~        2. To compare stent apposition and stent endothelialization after primary angioplasty using~          drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.~        3. To compare coronary endothelial function after primary angioplasty using drug eluting~          balloon/bare metal stent versus drug eluting stent versus bare metal stent.~   "
206623|NCT00856752|"~     A study in healthy volunteers to determine whether different drugs metabolised by the liver~     have any effects on how NRL972 is processed within the body.~   "
206624|NCT00856739|"~     Healthy adults aged 20-60 of varying weights will participate in this minimally invasive~     study. There is one 4-hour appointment for which subjects are paid $120. The tests involve: 1~     tube blood draw, 1 gait test (motion capture) and 1 MR of both knees.~   "
206625|NCT00856726|"~     The investigators aim to study potential racial differences in renal phosphorus handling by~     provocatively testing urinary phosphorus excretion using parathyroid hormone infusions in~     healthy white volunteers compared to healthy black volunteers.~   "
206626|NCT00856713|"~     A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age,~     gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)~   "
206627|NCT00856700|"~     Glucagon-like peptide 1 (GLP-1) is an intestinal peptide hormone secreted in a~     nutrient-dependent manner that stimulates the pancreatic beta cells to secrete more insulin~     in response to the same amount of blood glucose. In patients with Type 2 diabetes, GLP-1~     secretion is lower than normal, thus suggesting that the hormone may contribute to the~     pathogenesis of the disease. Whether infusion of GLP-1 affects endothelial function and~     glucose uptake in humans has never been investigated. In the current proposal, the~     investigators hypothesize that GLP-1 administration might ameliorate endothelial dysfunction~     in patients with metabolic syndrome. To test this hypothesis, the investigators will evaluate~     the acute effects of GLP-1 in the forearm circulation of patients with metabolic syndrome~     during local hyperinsulinemia by use of the forearm perfusion technique.~   "
206628|NCT00856687|"~     PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial~     allergen challenge on lung function and hence provide proof of mechanism for this agent.~   "
206629|NCT00856674|"~     The purpose of this study is to evaluate the safety of several dose levels of CCL2-LPM in~     patients with IgA Nephropathy who have high levels of protein in the urine.~   "
206630|NCT00856661|"~     The purpose of the study is to determine whether desmoteplase is effective and safe in the~     treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset~     of stroke symptoms.~   "
206631|NCT00856648|"~     The present study aims to evaluate the relationship between the level of SCI and the~     impairment of Colonic transit time (CTT) and Total transit time (TTT) by using the SmartPill~     device. The SmartPill, an FDA approved device, is a wireless capsule that is ingested and~     transmits values for GI pH, temperature, and pressure as it travels throughout the digestive~     system. The SmartPill can also be used to assess CTT and TTT. In comparing values for CTT,~     TTT, pH, temperature, and pressure in SCI patients to healthy, able-bodied controls, the~     SmartPill device may provide valuable insight into the pathophysiological implications of SCI~     on GI function. This information may allow medical professionals to provide more effective~     plans of care for this population, subsequentially enhancing quality and quantity of life.~     The SmartPill device may also provide a less invasive alternative to assessing these~     variables, compared to traditional modalities.~   "
206632|NCT00856635|"~     The main objective of the study is to determine whether glatiramer acetate 20 mg once daily~     reduces the amount of axonal loss in the optic nerve after a first event of acute optic~     neuritis compared to placebo patients and to generate data supporting the potential~     neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.~   "
206633|NCT00856622|"~     The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol~     (PhXA41) has better IOP lowering effect than the individual monotherapies.~   "
206651|NCT00856375|"~     This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect~     in patients with colorectal cancer. This study will also evaluate how the safety and~     anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for~     use in the US for treatment of patients with certain types of colorectal cancer.~   "
223643|NCT00631293|"~     Study of the effect of lactisole on glucose uptake~   "
206634|NCT00856609|"~     Exenatide is an incretin-like drug that has been approved for treatment of type 2 diabetes;~     it improves glycemia by increasing insulin and decreasing glucagon secretion by pancreatic~     islet cells and delaying gastric emptying. This randomized, placebo-controlled study is to~     evaluate whether exenatide over a 5 week period in non-diabetic obese subjects may lead to~     weight loss. To control for variability in individual response to weight loss treatment, this~     study will assess the role of exenatide in changing food intake and energy expenditure as~     possible sources of weight loss. This study will also evaluate the safety profile of~     exenatide in non-diabetic obese people. Additional assessments will evaluate changes in body~     fat and hormones involved in the sensations of hunger and fullness.~   "
206635|NCT00856596|"~     The topical cream, Sertaconazole (Ertaczo), has been FDA approved for the treatment of~     athlete's foot using twice a day dosing for 4 weeks. This study wants to see if sertaconazole~     will work equally as well with once a day dosing for 4 weeks for athlete's foot.~   "
206636|NCT00856583|"~     The purpose of the study is to determine whether there is an increased all-cause mortality in~     sertindole-treated patients in comparison to patients treated with a well-known antipsychotic~     (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.~   "
206637|NCT00856570|"~     This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to~     exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and~     tolerability of warfarin alone and combined with YM178.~   "
206638|NCT00856557|"~     This study assessed whether a medical education intervention improves the quality of medical~     decision making in the care of patients with complex psychosocial -- or contextual -- needs~     that are essential to address when planning their care. A group of internal medicine~     residents were randomly assigned to participate in the seminar and practicum and then they,~     along with a control group that had not participated, were assessed for the quality of their~     clinical decision making and its impact on patient care. The study also assessed whether~     contextualization of care is associated with better patient health care outcomes~   "
206639|NCT00856544|"~     This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg~     BID is safe and effective when used in combination with a variety of traditional disease~     modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to~     confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that~     were observed in the Phase 2 rheumatoid arthritis studies.~   "
206640|NCT00856531|"~     The Möbius syndrome constitutes a congenital disorder classically caused by genetic and~     environmental factors. The clinical manifestations include lesion of the facial and abducens~     nerves associated with limb malformations specially club foot. The speech-language~     manifestations include compromise of oral and deglutition, speech and language functions,~     secondary to cranial nerves lesions and mental retardation. The language compromise in this~     disorder is still not well known. In this way, the main objective of this study is to~     characterize the oral language in a population of fifteen subjects with Möbius syndrome with~     age ranging from two to thirteen years old, from both sexes, seen in one of the three main~     center for genetic diagnosis in the state of Ceará. The present work is a descriptive study~     of a cross-sectional design conducted from February to December/2002, using a clinical~     evaluation of language components including morphology, syntax, semantics and pragmatics. The~     investigators identified exclusive speech involvement in 20,0% of the subjects, language~     disturbance in 46,7%, speech and language disturbance in 13,3% and oral language involvement~     in 26,7%. The investigators conclude that the language disturbance in the Möbius syndrome~     presents with a variable compromise of all oral language components. The delay in~     linguistical development, incomprehensive speech and the deficit of constructions of~     sentences and narrations are constant.~   "
206641|NCT00856518|"~     Respiratory difficulty is one of the primary factors leading to death in patients with~     Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating~     diseases that cause difficulties in breathing, airway protection and swallowing. Patients~     with PD and MS typically become sedentary and lose endurance, maximal fitness levels and~     overall pulmonary function. Much of the research focus has been on the motor symptoms of PD~     and MS yet the pulmonary and swallowing complications are perhaps ultimately the most~     important disability as the diseases progress. The inability to generate adequate respiratory~     pressure is responsible for reduced cough magnitudes and cough response times. Cough is~     critical for the clearance of foreign materials in the airway helping to reduce infiltration~     of bacteria and subsequent respiratory infection. With reduced cough function an increased~     risk for pulmonary disease occurs due to a reduced ability to protect the airways. There are~     a number of promising outcomes from an expiratory strength-training program. By increasing~     expiratory muscle strength and expiratory pressure generation, effective breathing, clearance~     of the airway, and improved swallowing can occur. These explicit outcomes are predicted based~     on our experience with the use of an innovative device-driven, home-based expiratory strength~     training program focused on the expiratory muscles of respiration. This project focuses on~     following patients with PD and MS for an initial 5 weeks of strength training and them~     testing the outcome of a caregiver program for maintaining treatment effects.~   "
206642|NCT00856505|"~     In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like~     cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor~     immune cells. The hypothesis for this study is, that replacing calcineurin inhibitors by~     everolimus and mycophenolate as GvHD prophylaxis not only reduces toxicity of the treatment~     but also improves tolerance induction of the donor T cells toward the host, eventually~     increasing the safety of stem cell transplantation.~   "
206652|NCT00856362|"~     The purpose of this study is to evaluate the effect of single doses of midazolam on the~     plasma concentration of a single dose of moxidectin in healthy young adult subjects, and to~     assess the safety of co-administration of moxidectin and midazolam.~   "
206653|NCT00856349|"~     The purpose of this clinical trial is to determine whether periodic therapy programming~     reports illustrating physician usage of shock reduction programming can increase utilization~     of recommended programming guidelines for defibrillators.~   "
206654|NCT00856336|"~     This was a phase I study aimed at identifying safe doses of DMXAA (now known as ASA404) to be~     used in future combination studies with chemotherapy.~   "
206643|NCT00856492|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing.~     Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells~     found in bone marrow or peripheral blood and may help the immune system recover from the side~     effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth~     in different ways. Some find tumor cells and kill them or carry tumor-killing substances to~     them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may~     also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these~     treatments before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed. It is not yet known which treatment regimen is more effective in~     treating women with breast cancer.~      PURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized~     nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how~     well they work when given with or without bevacizumab in treating women with inflammatory or~     locally advanced breast cancer.~   "
206644|NCT00856479|"~     We are inviting individuals such as yourself, who have diaphyseal fracture (broken bone) with~     a non union to participate in this research study. A non-union is a lack of bone healing~     (bone growth where the break in the bone occurred) after 3 months after the operation. The~     diaphyseal is an area of a specific bone (usually near the middle) where the fracture~     occurred. The bones we are interested in are the clavicle (collar bone), tibia (lower leg),~     femur (upper leg), humerus (upper arm) and forearm (lower arm). Treatment goals for these~     types of fractures are to minimize later surgeries, to assist the healing process, and to~     decrease the time to healing. The ability of a patient with non-union (lack of bone healing~     after 3 months post operation) to return to the work force and to normal activities more~     quickly not only has a good financial impact on society (community), but also improves~     over-all physical and mental well-being of the patients.~      Infuse is a synthetic bone morphogenic protein which means it has the ability to help your~     bone to form and heal if inserted in the fracture site. Infuse may be the first~     commercially available product approved by Health Canada to accelerate the healing of long~     bone non-unions requiring surgical intervention.~      Although the safety and efficacy of Infuse has been demonstrated through numerous~     pre-clinical studies, further human clinical trial is needed to evaluate the safety and the~     power to produce effects of this product particularly with respect to non unions of long~     bones. The purpose of this study is to evaluate the safety and the power to produce effects~     of Infuse implanted during treatment of long bone non unions to reduce later surgeries~     required to augment the healing process and to accelerate the time to healing.~      Given this, the orthopaedic community has planned this study in order to scientifically~     establish the most effective treatment method to restore function after this type of injury.~   "
206645|NCT00856453|"~     RATIONALE: Yoga may decrease fatigue, distress, and depression, and improve sleep quality in~     patients undergoing chemotherapy for ovarian cancer. It is not yet known whether practicing~     yoga in group classes is more effective than practicing yoga at home.~      PURPOSE: This randomized clinical trial is studying how well yoga works in relieving fatigue~     in patients undergoing chemotherapy for ovarian cancer.~   "
206646|NCT00856440|"~     Periodic screening for colon cancer has become the standard of care in individuals over the~     age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive~     modality for the detection of colon cancer and/or pre malignant colon pathology. As currently~     performed, however, colonoscopy requires that stool be eliminated from the colon before the~     examination. If stool remains in the colon, visualization of the bowel will be partially or~     completely impaired and limits the effectiveness of the screening. A number of methods are~     employed for purging the bowel of waste material but they generally involve either~     administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an~     osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches~     is uniformly effective in all individuals and neither is without potential complications,~     especially on the kidneys. It is the intent of the proposed research to study the relative~     efficacy and safety of these preparations in both able-bodied individuals as well as people~     with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a~     laxative or a combination of the two prior to a routine, clinically indicated colonoscopy.~     The quality of the preparation will be directly assessed during the colonoscopy and the~     effect of these preparations on kidney function will be determined. We suspect that when it~     comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research~     should allow us to determine which form of preparation is least harmful while achieving~     optimal effectiveness.~   "
206647|NCT00856427|"~     This clinical trial studies imaging markers in planning radiation therapy in patients with~     lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during~     radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to~     normal tissue.~   "
206648|NCT00856414|"~     This study evaluates the patient satisfaction and onset of effect following treatment with~     botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)~   "
206649|NCT00856401|"~     The purpose of this protocol is to add on additional exploratory studies to investigate~     changes in bone quality parameters with PTH(1-84) treatment of hypoparathyroidism. In~     addition to the biochemical hallmarks of hypoPT, it has been found that the microscopic~     structure of the bone, as well as the bone remodeling system, are markedly abnormal in this~     disease. How these abnormalities may be corrected with PTH(1-84) administration are not fully~     understood. The studies outlined in this add-on protocol are designed to shed light on the~     mechanistic ways that PTH(1-84) replacement may restore normal bone metabolism. These~     mechanistic studies are beyond the scope of the parent NPS study, which was designed to~     assess the safety and efficacy of PTH(1-84) in hypoPT treatment. Subjects who are~     participating in the NPS' REPLACE, RELAY, and RACE Studies and the HEXT Study at Columbia~     University will be invited to participate in this add-on protocol, which will involve a~     separate IRB-approved informed consent.~      Study procedures:~        1. High Resolution Peripheral Quantitative Computed Tomography (HRpQCT; XtremeCT, Scanco):~          Done at the same visit as DXA. In the REPLACE study twice, in RELAY once (or not at all~          if done within the last 6 months), in RACE twice, and in HEXT three times.~        2. Osteolineage: At Baseline/Randomization/Visit One and at 4, 8, 12, 24, and 52 weeks of~          treatment in the REPLACE, RELAY, or RACE Study, if applicable, or at baseline and each~          6-months visit in the HEXT Study, blood test for circulating osteogenic cells (10 cc)~          will be performed~        3. Sclerostin: At Baseline/Randomization/Visit One and at 4, 8, 12, 24, and 52 weeks of~          treatment in the REPLACE, RELAY, or RACE Study, if applicable, or at baseline and each~          6-months visit in the HEXT Study, blood test for sclerostin (5cc) will be performed~      Funding Source - FDA OOPD~   "
206650|NCT00856388|"~     This clinical trial is studying how well giving fludarabine phosphate and melphalan together~     with total-body irradiation followed by donor stem cell transplant works in treating patients~     with hematologic cancer or bone marrow failure disorders. Giving low doses of chemotherapy~     and total-body irradiation before a donor peripheral blood stem cell transplant helps stop~     the growth of cancer cells or abnormal cells. It may also stop the patient's immune system~     from rejecting the donor's stem cells. The donated stem cells may replace the patient's~     immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor~     effect)~   "
206655|NCT00856323|"~     This study seeks to decrease methamphetamine use and concomitant high-risk sexual behaviors~     among methamphetamine-using men who have sex with men (MSM) by combining a biomedical~     intervention with a behavioral intervention. The behavioral intervention will consist of an~     8-week course of contingency management (CM) through which participants will be reinforced~     for testing negative for methamphetamine metabolites during periodic urine analyses. The~     biomedical intervention involves a 28-day course of an antiretroviral drug (Truvada) to be~     administered after an unanticipated HIV risk exposure (i.e., engaging in either receptive or~     insertive anal sex without a condom with someone who is HIV-positive or of unknown status).~     In combining these two interventions, this study seeks to evaluate the combined~     intervention's effects on sexual risk behaviors and methamphetamine use.~   "
206656|NCT00856310|"~     This is a randomized, double-blind, placebo-controlled single-dose study of the safety and~     tolerability of intravenously administered REGN475 in healthy volunteers. The primary~     objective of the study is to assess the safety and tolerability of REGN475. The secondary~     objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.~   "
206657|NCT00856297|"~     The primary objective is to evaluate the persistence of bactericidal antibodies in~     adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY~     Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also~     enroll age-matched subjects who have never received any other meningococcal vaccine (naïve~     subjects) to serve as an additional control group.~   "
206658|NCT00856284|"~     The purpose of this study is to determine the safety and effectiveness of adding alogliptin,~     once daily (QD), compared to glipizide with metformin in diabetic patients.~   "
206659|NCT00856271|"~     The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil~     compared with losartan potassium in patients with mild to moderate essential hypertension.~   "
206660|NCT00856258|"~     To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.~   "
206661|NCT00856245|"~     Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell~     transplantation will help patients get rid of their lymphoma cells from the bone marrow and~     stem cell collections.~   "
206662|NCT00856232|"~     This study will randomly assign emergency department patients seeking treatment for a~     headache to one of three groups. The first group will receive standard emergency care as~     determined by the treating physician, the second group will breathe high flow air by facemask~     for 15 minutes, and the third group will breathe high flow oxygen by face mask for 15~     minutes. The patients will be questioned in the beginning of their treatment and at 2, 5, 10,~     15 and 30 minutes after it's begun about the intensity of their headache and how much relief~     they are experiencing from their treatment. Concentration of carbon dioxide exhaled by~     patients will also be recorded at 0, 2, 5, 10, 15 and 30 minutes. After fifteen minutes, the~     patients in groups 2 and 3 will continue with standard emergency care, which can include any~     treatment their physician sees fit. Patients in all three groups will receive a stopwatch in~     the beginning of their emergency department visit and record the total extent of time their~     headache will take to resolve.~   "
206663|NCT00856219|"~     Literature suggests that route of feeding and/or certain nutrients may cause alterations in~     the body's immune cells. Immune cells help protect the body and fight infection/disease. Tube~     feeding (TF) is a method of delivering nutrition directly to the stomach/intestines via a~     small tube. The immune system may respond differently when receiving continuous TF as~     compared to receiving intermittent TF. Heart rate variability (HRV, the intervals between~     heartbeats) is a measurement of the nervous system's response to a stress/illness. The~     differences in immune cells and/or HRV may influence how the body reacts to complications~     such as infection.~   "
206664|NCT00856206|"~     The purpose of this clinical research study is to determine the safety and effectiveness of~     an experimental drug called rilonacept in subjects with gout who are on urate-lowering~     therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is~     being studied for use in preventing gout flares in subjects on urate-lowering therapy.~   "
206665|NCT00856193|"~     This study was intended to assess how well inhaled NVA237 opens up the airways of patients~     with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.~   "
206666|NCT00856180|"~     The goals of this study were to evaluate the efficacy and safety of sequentially blocking the~     angiogenesis pathway via known antiangiogenic mechanisms, first with bevacizumab and then~     addition of oral cyclophosphamide upon progression of cancer through bevacizumab. The drugs~     used in this study were chosen because of their known antiangiogenic properties,~     tolerability, and anti-ovarian cancer effects.~   "
206667|NCT00856167|"~     This study seeks to evaluate the benefits of different combinations of a Self Care program,~     involving individually targeted education and support, plus Traditional Chinese Medicine, in~     terms of patients' experience and outcomes in short-term follow-up (8 weeks) and long-term~     follow-up (18-months). The study seeks to evaluate the benefits and drawbacks of different~     patterns of stepped care, which means different levels of care depending on patients'~     responses at various time-points in the study, which might be used by clinicians treating in~     the future.~   "
206668|NCT00856154|"~     Phase I test of concept study: In an attempt to induce new immunity to HIV-1 during untreated~     HIV-1 infection the investigators have identified relatively immune silent immune subdominant~     HLA-A2-restricted HIV-1 CTL epitopes that fit individuals with the HLA-A2 tissue type (about~     50% of peoples in Denmark). Immunising with these conserved epitopes could induce new~     immunity and lower viral load so the patient will live longer before AIDS or Antiviral~     medicine and a lower viral load will limit spread in the population. As adjuvants the~     investigators used patients' own autologous Dendritic Cells generated from blood cells in~     vitro. 12 healthy male HIV-1 infected not in therapy individuals were used for this~     therapeutic vaccination and tested for safety and induction of new cellular CD8 and CD4~     T-cell immunity.~   "
206682|NCT00855959|"~     The primary objective of the study is to show similarity of efficacy on Pulmicort Respules~     1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of~     Pulmicort Turbuhaler 400 μg/day or 800 μg/day for 4 weeks in the observation period in~     Japanese adult asthmatic patients with age of 16 years or older.~   "
224270|NCT00622947|"~     The aim of the present study is to compare the antidepressant effect of low frequency rTMS~     applied over the right temporal cortex with sham stimulation.~   "
206669|NCT00856141|"~     In this modern era, surgeons prefer to perform emulsification through small micro incisions.~     To accomplish this safely, surgeons raise irrigation bottle heights or use forced infusion~     systems.We believe that this sustained rise in the IOP during micro-incision~     phacoemulsification for a substantial period could be detrimental to the ocular structures.~     Therefore, intra-operative IOP pertaining to micro-incision cataract surgery is an emerging~     concern.~      Conventional systems for measuring IOP generate an isolated graph of continuous pressure~     recording. Interpretation of the IOP fluctuations from these graphs requires a two step~     superimposition approach to characterize the IOP changes.~   "
206670|NCT00856115|"~     RATIONALE: Gathering information about timely diagnosis in African American and Caucasian~     patients with newly diagnosed colorectal cancer may help doctors learn more about factors~     that influence a diagnosis and plan the best treatment.~      PURPOSE: This phase I trial is studying differences in timely cancer diagnosis in African~     American patients and in Caucasian patients with newly diagnosed colorectal cancer.~   "
206671|NCT00856102|"~     The objective of the proposed research is to determine the efficacy of a home-based walking~     exercise program in promoting cognitive-psychosocial functions of men with prostate cancer~     receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with~     advanced prostate cancer. However, ADT has a number of side effects including compromised~     cognitive function, depression and anxiety, which negatively impacts the quality of life of~     men with prostate cancer. The central question of the proposed research is to determine if~     exercise will have a positive impact on the quality of life of men with prostate cancer~     undergoing ADT.~      Hypothesis:~   "
206672|NCT00856089|"~     The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is~     effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal~     colonization. The hypothesis is that the prevalence of MRSA increases as a function of~     increasing clinical exposure and that the topical antibiotic Altabax is efficacious in~     clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane~     University medical students and residents and physicians of Tulane Medical Center and Ochsner~     Medical Center will be investigated. A total of 300 subjects will be recruited for the study.~     After giving informed consent, subjects will be swabbed to obtain specimens for culture and~     asked to complete a short survey to assess risk factors. Swabs will be used to directly~     inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with~     sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and~     then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects~     will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin~     ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days.~     After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at~     day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will~     additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin~     (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition,~     Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by~     rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk~     factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data~     from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA~     nasal colonization.~   "
206673|NCT00856076|"~     The purpose of this study is to investigate clinical, biochemical and genetic risk factors~     for venous thromboembolism in pregnancy and pregnancy related vascular complications, and the~     long-term outcome of such complications including implications for quality of life.~   "
206674|NCT00856063|"~     The goal of this pilot feasibility and utility study is to develop and validate a method that~     is reproducible over time for assessing biobehavioral and autonomic markers of impulsivity~     and their utility in assessing treatment outcome in preschool children with ADHD.~   "
206675|NCT00856050|"~     The purpose of this research study is to determine if letrozole is effective at controlling~     the growth or spread of estrogen and/or progesterone receptor positive uterine~     leiomyosarcoma. This drug has been used in research studies for other cancers and is~     currently approved by the FDA for use in breast cancer. Because letrozole lowers hormone~     levels in the body, it may be helpful to control tumors that express hormone receptors (~     ER/PR).~   "
206676|NCT00856037|"~     This phase I trial studies the side effects and best dose of topotecan hydrochloride when~     given together with doxorubicin hydrochloride in treating patients with small cell lung~     cancer (SCLC) that has come back after a period of improvement (relapsed) or has not~     responded to treatment (refractory). Drugs used in chemotherapy, such as topotecan~     hydrochloride and doxorubicin hydrochloride, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Doxorubicin hydrochloride may also stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving topotecan hydrochloride and doxorubicin~     hydrochloride may be a better treatment for small cell lung cancer.~   "
206677|NCT00856024|"~     This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open,~     noncomparative, and nonrandomized study, which does not have visits. This study will be~     conducted in accordance to Good Clinical Practices. The procedure will be the review of~     medical records of patients who have already completed 12 weeks of treatment of chronic~     hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the~     subjects have signed the informed consent form authorizing collection of these data. The~     collection of data for virological response after Week 12 will be collected prospectively~     through the review of medical records after the subjects have completed their entire~     treatment and follow-up period.~   "
206678|NCT00856011|"~     The underlying basis of carpal tunnel syndrome and the basis of its increased incidence in~     diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed~     nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients~     with CTS.~   "
206679|NCT00855998|"~     This study aimed to compare the activity of Thymidine Kinase 1 in serum of two groups of~     woman at high and normal risk for breast/ovary cancer.~   "
206680|NCT00855985|"~     There are two principal ways of draining the remnant of the pancreas back into the intestine~     after removal of the head of the pancreas for cancer. This can be performed either to the~     jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients~     to one of the two arms to study whether the leak rates from the anastomosis and the outcomes~     after the surgery are affected.~      Previous papers have shown similar results in both groups although non randomized data~     suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior~   "
206681|NCT00855972|"~     The purpose of this research is to obtain data or information on the safety and effectiveness~     of low dose naltrexone (LDN) for treating the symptoms of juvenile primary fibromyalgia~     syndrome. This is a dose finding study to find whether LDN helps the symptoms of juvenile~     fibromyalgia, and at what dose it does so.~   "
206683|NCT00855946|"~     Treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy~     before surgery with total mesorectal excision in order to reduce tumor infiltration,~     facilitate oncologic surgery and improve survival. About fifty percent of these patients are~     good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph~     nodes in order to be graded ypT0 to T2 N0 after pathologic assessment (so called~     downstaging). At the opposite, bad responders (ypT3-4 and/or N+) are not sensitive to~     standard preoperative radiochemotherapy, and their survival is poor than good responders.~     Until now, response to preoperative radiochemotherapy cannot be anticipated before~     pathological assessment of surgical specimen. Proteomic analysis of sera from good and bad~     responders to preoperative radiochemotherapy could allow identification of early biomarkers~     of tumor response, and subsequently adaptation of treatment to increase preoperative~     treatment efficiency and survival in most patients.~   "
206684|NCT00855933|"~     This is a randomized, controlled, examiner-blind, parallel group, four week clinical study~     comparing brushing plus flossing to brushing alone in healthy adults with mild-to-moderate~     gingivitis.~   "
206685|NCT00855920|"~     This purpose of this clinical research was to determine the efficacy and safety of an~     experimental drug called Rilonacept in participants with an acute gout attack. Participants~     participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin~     alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.~   "
206686|NCT00855907|"~     Fatty liver is known to be one of the most frequent liver pathologies in IBD patients~     (35-40%). Despite this fact, there are only few publications that evaluated the prevalence of~     fatty liver in IBD patients. Moreover, the pathogenesis of this phenomenon in IBD has not~     been widely investigated.~      The paradox of lean patients and fatty liver can be explained by high use of steroids, by~     rapid weight loss, and by the abundance of TNFα cytokine in IBD patients that causes insulin~     resistance.~      The aim of the study:~      To evaluate the frequency of fatty liver in a cohort of IBD patients and to learn its risk~     factors.~      Methods:~      One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be~     recruited.~      Patients will fill up a questionnaire regarding their disease, demographic data, other~     co-morbidities and medications and risk factors for metabolic syndrome.~      Each patient will undergo blood examinations in order to assess inflammation, and metabolic~     status. Fatty liver will be assessed by liver ultra-sonography.~   "
206687|NCT00855894|"~     This was a Phase II, open-label, single-arm, single-stage, multicenter trial in patients with~     relapsed non-small cell lung cancer (NSCLC), with the objective of assessing the activity of~     the combination of erlotinib and pertuzumab on the basis of the endpoint of FDG-PET response~     rate.~   "
206688|NCT00855881|"~     It is the investigators understanding that the combination of clinical trial with laboratory~     cellular/molecular assay is relevant to the current promising mainstream, the translational~     research. The design of this trial fulfills this concept and would be a good example~     conducting in Mackay Memorial hospital.~   "
206689|NCT00855868|"~     This study will evaluate the performance characteristics of a novel [18F] amyloid detection~     ligand (18F]-AV-45) with respect to its ability to distinguish patients with~     clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects~     and to independently compare its diagnostic performance characteristics with the ability of~     [11C]PIB to correctly categorize the same subjects.~      SPECIFIC HYPOTHESES~        1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have~          increased brain retention of [18F]-AV-45 compared to cognitively normal elderly~          individuals.~        2. There will be no clinically meaningful difference in the amyloid retention performance~          characteristics of [18F]-AV-45 and [l1C]PIB.~   "
206690|NCT00855855|"~     To monitor the occurrence of invasive Hib disease over time and to determine product-specific~     rates of invasive Hib disease within the monitored population.~   "
206691|NCT00855842|"~     One the day prior to medical abortion (labor induction) in the second trimester, insertion of~     osmotic dilators is added to the routine procedures. The study is to see whether the addition~     of dilators decreases the abortion time (time for the pregnancy to be expelled)~   "
206692|NCT00855829|"~     ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain~     associated with menstruation (clinically known as dysmenorrhea).~   "
206693|NCT00855816|"~     Hyperarousal is a key symptom of PTSD. Even after receiving trauma-focused therapy, PTSD~     patients may continue to suffer from hyperarousal. Our main objectives are to measure~     hyperarousal in VA outpatients with PTSD related to combat experience in the last 10 years~     and to test the efficacy of physiological relaxation training in reducing this hyperarousal.~     Measurements will be both physiological, using 24 hour ambulatory monitoring of skin~     conductance, heart rate, and physical activity during waking and sleeping, and psychological,~     using self-reports and clinician interviews. Specific aims include initially evaluating 100~     or more PTSD patients for the severity of their hyperarousal symptoms. Of these, 50 with at~     least moderate hyperarousal who either have participated in a trauma-focused therapy or have~     declined to participate in such a therapy will be recruited for a therapy trial. Volunteers~     will be randomized to treatment consisting of 5 sessions of individual physiological~     relaxation training with biofeedback over a 4-week period or to a 2-month waiting period~     after which they also may receive this therapy. Physiological evaluations of the patients'~     ability to relax will be measured at three times -before treatment, immediately after~     treatment, and 6 months after treatment. Clinical evaluations by interviews and~     questionnaires on measures of symptoms and disability will be measured at four times - before~     treatment, immediately after treatment, 1 month after treatment, and 6 months after~     treatment. The waiting-list group and a nonanxious control group will be tested~     psychophysiologically twice at the same interval as the patients before and immediately after~     treatment. A control group will allow us to calibrate our measures in the setting in which~     they are being applied. We hypothesize that this therapy will relieve both self-reported and~     objective, physiological symptoms of hyperarousal.~      Relevance to health and the VA mission: Many of our clients at the VA Palo Alto Mental Health~     Outpatient Services for PTSD are veterans of Iraq, who need help with hyperarousal symptoms.~     This study will fill in gaps in our knowledge about the physiology of these symptoms and~     about the efficacy of relaxation therapies. Non-pharmacological treatments like the ones that~     we propose may relieve patients' hyperarousal to an extent that they are less tempted to turn~     to alcohol or sedative drugs.~   "
206694|NCT00855803|"~     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and~     spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation~     therapy together with vertebroplasty may help lessen pain and improve quality of life of~     patients with spinal metastasis.~      PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy~     together with vertebroplasty works in treating patients with localized spinal metastasis.~   "
206695|NCT00855790|"~     The purpose of this study is to evaluate the efficacy of the new RJ4 compare with the~     standard RJ3 biopsy forceps for performing polypectomy for small colorectal polyps.~   "
206696|NCT00855777|"~     The aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a~     well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar~     extraction pain. At this time, there are no data about the efficacy of etoricoxib for~     reducing pain following dental extraction.~      This will be a single center, randomized, double-blind study, in which patients with moderate~     to severe pain following third molar extraction will be randomized to receive etoricoxib (120~     mg in a single dose + 2 dose of placebo pro day for 3 days) or ibuprofen (1800 mg in 3 doses~     pro day for 3 days). Paracetamol plus codeine will be used as rescue medication. Pain~     assessment will be performed using a 11-point pain intensity scale (0 = no pain and 10 =~     worster pain) during the first 3 days after dental extraction. Patients will be enrolled 15~     days before the dental extraction. During enrollment visit a complete clinical evaluation~     with particular attention for potential exclusion criteria (e.g. hypertension and~     cardiovascular risk factors) as well as blood analyses will be performed. A follow-up visit~     will be performed 15 days after the dental extraction. Tolerability will be assessed through~     recording of adverse events.~   "
206697|NCT00855764|"~     The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given~     weekly in patients with advanced or recurrent head and neck cancer~   "
206698|NCT00855738|"~     Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs~     (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and~     topiramate, used as first-choice combination therapy (bitherapy) in patients with focal~     epilepsy.~   "
206699|NCT00855725|"~     The goal of this study is to determine whether there are unique markers on neuroimaging that~     are associated with depression in epilepsy.~   "
206700|NCT00855712|"~     The purpose of the study is to compare survival of both patients and newly transplanted~     hearts following heart transplantation among patients who were transplanted with donated~     hearts preserved on ice and those who were transplanted with donated hearts using the Organ~     Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused~     beating state. The study also compares the number of rejection episodes, heart related~     adverse events, ICU time, and ventilation time between the two groups. The study is~     considered a success if survival in the OCS group was not inferior to the ice group.~   "
206701|NCT00855699|"~     Once someone becomes dependent on alcohol (alcoholic), the risks of complications from~     alcohol withdrawal when they stop drinking grow. These can include a life−threatening fit or~     delirium tremens (see things, become frightened). To prevent such complications, people take~     medication such as benzodiazepines (e.g., valium or librium) in reducing doses for about a~     week; this is called detoxification or 'detox.' In the UK effective alcohol treatment exists~     but little is known about what is the best detox medication. Alternative drugs to~     benzodiazepines appear to protect the brain from the toxicity of alcohol withdrawal and to~     reduce the likelihood of drinking again. This study will examine the feasibility of comparing~     medication regimens for alcohol detox for the first time in primary care. It will include a~     standard detox regimen (librium over 8 days) alone and together with a drug, acamprosate,~     that has been shown to reduce toxicity of alcohol withdrawal in preclinical models and is~     used after detox to help people remain sober. It will focus on the practicalities of doing~     such a study as well as assessing how people feel (withdrawal symptoms) and do (drinking~     during first month).~   "
206702|NCT00855686|"~     The purpose of this exploratory study is to determine whether memantine can provide benefits~     on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy~     Bodies.~   "
206703|NCT00855673|"~     The study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA)~     for the treatment of claudication and peripheral arterial disease.~      Major endpoints are improved exercise tolerance and relevant blood pressure ratios~   "
206704|NCT00855660|"~     Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days,~     on bone metabolism.~   "
206705|NCT00855647|"~     To demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated~     radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and~     effective in the treatment of low-risk localized prostate cancer.~   "
206706|NCT00855634|"~     PaMeViTUM is a mono-centric prospective randomized controlled trial that compares different~     operating procedures in patients with pancreatic cancer and minimal metastatic disease or~     venous infiltration.~   "
206707|NCT00855621|"~     The purpose of this study is to identify factors predicting good results in patients treated~     with deep brain stimulation for Parkinson's disease. The study includes a comparison of two~     surgical methods used to provide this therapy.~   "
206708|NCT00855608|"~     Direct intravitreal administration of medication is the preferred method of treatment for~     uveitis and retinal vascular disorders. The eye is a self contained organ relatively isolated~     from the systemic circulation by the tight blood retinal barrier. Effective intraocular drug~     levels can be achieved with a much smaller amount of medication if injected intravitreally~     and this also results in minimal systemic exposure to the patient. Preliminary studies have~     shown that adalimumab may have a positive role in the management of uveitis in humans and can~     be an effective treatment intravitreally in animal models. No data has been published yet on~     intravitreal use of adalimumab in human subjects.~   "
206709|NCT00855595|"~     Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15%~     gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole~     1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at~     total of twelve weeks to determine the rapidity of improvement, and the length of time to~     reach 25%, 50% and 75% clearing compared to baseline.~   "
206710|NCT00855582|"~     Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and~     5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and~     symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of~     BPH.~   "
206725|NCT00855387|"~     The purpose of this study is to prospectively assess the impact of surgical quality on the~     overall cost of major surgical procedures using the incidence and severity of complications~     as surrogate markers of quality.~   "
208781|NCT00828178|"~     The investigators hypothesize that low-dose dietary supplementation with omega-3 fish oil~     will improve disease activity and endothelial function in Systemic Lupus Erythematosus (SLE)~     patients.~   "
206711|NCT00855569|"~     The rationale underlying the study is that donor site bleeding is common and often~     problematic when presenting to the burn surgeon or staff. Frequently, gauze wound dressings~     are not sufficiently hemostatic to control a donor site bleed thereby leading to~     administration of vasoconstrictive agents and repeated application of wound~     dressing/pressure. The hemostatic textile Stasilon™ has proven superior to gauze in reducing~     bleeding from anesthetized pigs undergoing standardized surgically-induced trauma. Also,~     observational case reports have noted cessation of bleeding in a limited number of human~     patients with difficult to control bleeds.~   "
206712|NCT00855556|"~     The goal of the study is to develop and organize an effort to identify genes that determine~     an individual's risk for developing Parkinson's disease (PD).~        1. To ascertain, study and establish a repository of DNA samples that will allow for the~          identification of known and yet-to-be-identified genetic markers associated with the~          development of PD.~        2. To create a database with clinical, genetic (HLA, genome screen) and medical history~          information that will facilitate the search for PD susceptibility genes.~        3. To provide a centralized DNA repository to allow for targeted studies of genetic factors~          contributing to the onset, heterogeneity and progression of PD.~        4. To evaluate opportunities to extend the results of research to develop methods of risk~          prediction, prevention and therapy for PD.~   "
206713|NCT00855543|"~     The purpose of this study is to better understand (1) if phospholipase A2 producing~     microorganisms and cytokines (IL-1, IL-4, IL-6, IL-10, and IL-13) are associated with~     premature labor (2) if pregnant teens are more likely to have phospholipase A2 producing~     bacteria than a pregnant adults and (3) if there is a difference in the cytokines between~     pregnant teens and adults.We hypothesize that phospholipase producing microorganisms may~     trigger the onset of premature labor. The following are hypothesized: (a) The microorganism~     cultured should show high activities of phospholipase A2 (b) The cervical length measurement~     predictive value should correspond to the gestation age at term (c) Vaginal flora of teen~     will be more susceptible to colonization with higher phospholipase A2 producing bacteria than~     that of an adult (d) The maternal genotype contribution to the concentration of IL-1, IL-4,~     IL-6, IL-10, IL-13, and TNF-alpha during the first trimester of pregnancy in teens is~     different in the production of inflammatory cytokines and modulators(e) The maternal genotype~     of teens therefore influences the production of phospholipase A2 and causes an increase in~     preterm delivery.~   "
206714|NCT00855530|"~     Primary objective:~      - To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with~     major depressive disorder (MDD).~      Secondary objective:~      - To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for~     pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with~     MDD, and to evaluate the efficacy of amibegron in patients with MDD.~   "
206715|NCT00855517|"~     The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost-~     PPDS in subjects with ocular hypertension or open-angle glaucoma.~   "
206716|NCT00855504|"~     Infections affecting the mother during pregnancy may produce alterations in the normal~     cytokine and hormone-regulated gestation, which could result in preeclampsia, preterm labor,~     premature rupture of membranes, and preterm birth. Therefore, pregnant women with periodontal~     disease may show an alteration in the cytokine levels which may cause preeclampsia in them.~   "
206717|NCT00855491|"~     The purpose of this study what to evaluate if axial myopia might influence the development of~     PCO.~   "
206718|NCT00855478|"~     To assess the safety and effecacy of the Cypher stent ™ & Cypher Select ™ in the normal use~     of medical practices, within the labeled indications.~   "
206719|NCT00855465|"~     The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521,~     given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension~     (CTEPH).~   "
206720|NCT00855452|"~     The present protocol is a phase 2 study designed to investigate the potential application of~     allogeneic cell-mediated immunotherapy in metastatic solid tumors, similarly to the well~     established graft versus leukemia (GVL) effects, in patients with metastatic solid tumors~     resistant to conventional treatment modalities. Patients will be eligible to participate in a~     treatment program based on systemic administration of mismatched lymphocytes activated in~     vitro with rIL-2 (LAK) followed by rIL-2 inoculation in vivo. This treatment is aiming to~     induce an anti-tumor effect mediated by the efficient killing activity of the rIL-2 activated~     cells. Prior to cell infusion patients will receive the conditioning treatment with low dose~     Cyclophosphamide (Cyc) or Fludarabine with 2 injections of low dose alpha interferon. Cell~     therapy will be combined with specific anti-tumor monoclonal antibodies if available for the~     specific disease. Further activation of the anti-tumor activity of alloreactive donor T cells~     and natural killer (NK) cells will be accomplished by in vivo inoculation of rIL-2, aiming~     for enhancing the anti-cancer potential of donor-derived effectors cells. Patients will~     receive one - three cycles of cell therapy, as long as there are no signs of Graft- versus -~     Host - disease (GVHD) and the malignant disease is controlled.~   "
206721|NCT00855439|"~     This study will look at whether or not the medication exenatide improves signs and symptoms~     of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate~     diabetic peripheral neuropathy.~   "
206722|NCT00855426|"~     Nondisplaced hip fractures may be radiographically occult and require MRI or single photon~     emission CT bone scintigraphy for accurate diagnosis. Both examinations are expensive and are~     not readily available in many hospitals. Ultrasound (US) examination is relatively~     inexpensive and preliminary data had demonstrated its efficacy in detecting occult fractures~     in other sites. Our objective is to evaluate US examination as a screening tool for occult~     hip fractures in posttraumatic painful hips in the elderly.~   "
206723|NCT00855413|"~     Purpose: This is a pilot study to evaluate HIV viremia and persistence in acutely HIV~     infected antiretroviral naïve patients treated with Darunavir/ritonavir and Etravirine~      Participants: 20 participants, age 18 and older, HIV infected, antiretroviral naïve patients~      Procedures (methods): ARV treatment with Darunavir/ritonavir and Etravirine,~      Optional studies:~      Genital secretion samples, Cerebrospinal fluid samples, Leukapheresis, Endoscopy/colonoscopy~   "
206724|NCT00855400|"~     The purpose of this clinical trial is to asses the feasibility and the security of the~     intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic~     Lateral Sclerosis patients.~   "
206726|NCT00855374|"~     Thrombin is the most potent activator of platelets, and platelet activation is a hallmark of~     thrombosis. Coronary artery disease (CAD) is the major cause of mortality and morbidity in~     the United States and other industrialized countries, and thrombotic sequelae are the key~     cause of death in diabetes. The accumulation of thrombin at sites of vascular injury provides~     one of the major mechanisms of recruiting platelets into a hemostatic plug. Thrombin works by~     activation of the G protein-coupled protease activated receptors PAR1 and PAR4 on human~     platelets to initiate signaling cascades leading to increases in [Ca]i, secretion of~     autocrine activators, trafficking of adhesion molecules to the plasma membrane, and shape~     change, which all promote platelet aggregation. The thrombin receptors work in a progressive~     manner, with PAR1 activated at low thrombin concentrations, and PAR4 recruited at higher~     thrombin concentrations. As direct thrombin inhibitors become widely used in clinical~     practice, it is important to assess their effects on vascular function. Our hypothesis is~     that PAR1 and PAR4 do not signal through the same G protein pathways, and that PAR4 is not a~     strong platelet agonist. To investigate this hypothesis, the investigators will study the G~     protein pathways downstream of PAR4, and assess ex-vivo platelet responsiveness to thrombin,~     PAR1, and PAR4 agonist peptides, both in normal human subjects, and along the stages of~     pathology, from patients with stable angina as well as unstable angina who are undergoing~     angioplasty. Similarly, the investigators will examine platelet function in patients with~     metabolic syndrome as well as diabetes, along the continuum from insulin resistance to~     full-blown disease. These studies will provide deeper insight into the G protein pathways~     used by PARs. They will elucidate the contribution of PAR receptors to normal platelet~     function as well as the abnormal platelet activation in thrombotic states. The long term goal~     is to understand the implications for PAR receptors as therapeutic targets for anti-platelet~     therapies that may carry less bleeding risk.~   "
206727|NCT00855361|"~     The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the~     safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in~     newborns and pre-term infants.~   "
206728|NCT00855348|"~     The purpose of this study is to collect blood specimens and clinical data from screening~     guideline eligible individuals designated by their physician to receive a screening~     colonoscopy, and to evaluate the performance of a colorectal cancer-specific DNA methylation~     biomarker for detection of colorectal cancer in this cohort. Based on the outcome of the~     colonoscopy, polypectomy, biopsy and surgical tissue histopathology, the clinical utility of~     Septin 9 as colorectal cancer screening test will be evaluated.~   "
206729|NCT00855335|"~     The purpose of this study is to study how changes in the body during pregnancy influence the~     blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat~     taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and~     ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study~     will examine how these drugs are absorbed in the body, how they are distributed within the~     body and how they are removed from the body over time. Any pregnant woman who is currently~     receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for~     HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll.~     Patients must be willing to remain on study medication during the course of their pregnancy,~     and 12 weeks postpartum. The information collected may help answer questions about how to~     best prescribe these three drugs for pregnant women.~   "
206730|NCT00855322|"~     The purpose of this study is to determine whether exercise is beneficial for people with~     rheumatoid arthritis(RA) taking antiTNFalpha medication~   "
206731|NCT00855309|"~     RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in~     patients with neutropenia.~      PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is~     comparing two doses of acyclovir in preventing herpes simplex virus infection in patients~     with neutropenia.~   "
206732|NCT00855296|"~     Thrombin is the most potent activator of platelets, and platelet activation is a hallmark of~     thrombosis. Coronary artery disease (CAD) is the major cause of mortality and morbidity in~     the United States and other industrialized countries, and thrombotic sequelae are the key~     cause of death in diabetes. The accumulation of thrombin at sites of vascular injury provides~     one of the major mechanisms of recruiting platelets into a hemostatic plug. Thrombin works by~     activation of the G protein-coupled protease activated receptors PAR1 and PAR4 on human~     platelets to initiate signaling cascades leading to increases in [Ca]i, secretion of~     autocrine activators, trafficking of adhesion molecules to the plasma membrane, and shape~     change, which all promote platelet aggregation. The thrombin receptors work in a progressive~     manner, with PAR1 activated at low thrombin concentrations, and PAR4 recruited at higher~     thrombin concentrations. As direct thrombin inhibitors become widely used in clinical~     practice, it is important to assess their effects on vascular function. Our hypothesis is~     that PAR1 and PAR4 do not signal through the same G protein pathways, and that PAR4 is not a~     strong platelet agonist. To investigate this hypothesis, the investigators will study the G~     protein pathways downstream of PAR4, and assess ex-vivo platelet responsiveness to thrombin,~     PAR1, and PAR4 agonist peptides, both in normal human subjects, and along the stages of~     pathology, from patients with stable angina as well as unstable angina who are undergoing~     angioplasty. Similarly, the investigators will examine platelet function in patients with~     metabolic syndrome as well as diabetes, along the continuum from insulin resistance to~     full-blown disease. These studies will provide deeper insight into the G protein pathways~     used by PARs. They will elucidate the contribution of PAR receptors to normal platelet~     function as well as the abnormal platelet activation in thrombotic states. The long term goal~     is to understand the implications for PAR receptors as therapeutic targets for anti-platelet~     therapies that may carry less bleeding risk.~   "
206733|NCT00855283|"~     DWE (difficulty with evacuation) is a common and an important quality of life issue after~     spinal cord injury. Not only is the management DWE time-consuming and unpleasant, but the~     results are often suboptimal in terms of complications such as incontinence and impaction.~     Bowel care regimens after spinal cord injury have not changed in any significant fashion in~     many years. The usual strategies for attaining bowel evacuation involve dietary manipulation~     (e.g., high fiber diets and hydration), thrice weekly laxative administration (senna and~     cascara) and thrice weekly anorectal instillation of cathartics (enemas and suppositories).~     Bowel care can be quite time consuming (greater than 2 hours in many instances) and may also~     require extensive nursing care. Finally, incomplete evacuation could contribute to fecal~     incontinence that has significant morbidity in these patients.~      In preliminary studies performed at the JJPVAMC, IV, IM, and subcutaneous injection of~     neostigmine combined with glycopyrrolate were demonstrated to be highly effective to promote~     bowel evacuation in the SCI population. In an effort to provide a more realistic~     administration of this procedure, we propose to test the intranasal spray injection of~     neostigmine and glycopyrrolate for safety and efficacy.~   "
206734|NCT00855270|"~     This study is designed to test the hypothesis that a single Hydrocortisone intra venous~     injection within 6 hours post-trauma facilitates physiological recovery thereby preventing~     the development of Post Traumatic Stress Disorder (PTSD) in the months following the event.~     In the absence of such treatment (i.e., under placebo conditions), we hypothesize that a~     greater proportion of persons would develop PTSD (i.e., fail to recover from acute effects).~   "
206747|NCT00855101|"~     This study is to assess the plasma concentration-time profile of voriconazole in adults~     receiving 7-day intravenous treatment and 6.5-day oral treatment. This study is also to~     assess the safety profile of voriconazole during the treatment period.~   "
212839|NCT00774215|"~     This study is a 1 year review of all patients who had surgery to correct pelvic organ~     prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit.~   "
206735|NCT00855257|"~     The investigators' work proposes to evaluate the effectiveness of the Acid Nicotinique~     (Niaspan®), only molecule currently marketed, ready to raise the plasmatic levels of HDL-c.~     This effectiveness will be tested among patients having presented recently an acute coronary~     syndrome. The effectiveness of the molecule will be appreciated versus placebo after~     randomization.~      The technique of evaluation of this effectiveness will be the analysis of the vasodilatation~     endothelial-dependent measured on the level huméral (by echography high resolution).~      The awaited result is an improvement of 2% in value absolute of this vasodilatation between~     the initial test and the end of study for the patients receiving the acid nicotinic versus~     those receiving the placebo (3 months of treatment after inclusion). The calculation of the~     sample necessary to achieve this goal envisages 70 patients led at the end of the study,~     divided into two groups of treatment (acid nicotinic or Placebo).~      Such a result if it were obtained would be higher than that found in studies evaluating the~     effect on the vasomotricity endothelial statins or inhibitors of the enzyme of conversion.~   "
206736|NCT00855244|"~     Life for long-term bone marrow transplant patients is complicated by endocrine late effects~     including growth hormone (GH) deficiency, thyroid hormone deficiency and sex steroid~     deficiency. Recently, studies have also identified problems with metabolic syndrome in adult~     bone marrow transplant (BMT) survivors. Metabolic syndrome has been identified as a~     constellation of insulin resistance, truncal obesity and high lipid levels (dyslipidemia) and~     is associated with an increased risk of type 2 diabetes and cardiovascular disease. Thus the~     early identification of metabolic syndrome is important. To date, studies have not identified~     how young an age metabolic syndrome begins in BMT survivors.~      The investigators' study will consist of two aims:~        1. Evaluation of children who have survived BMT for growth hormone deficiency, abnormal~          lipid metabolism, hypothyroidism and gonadal dysgenesis. The investigators will utilize~          growth hormone stimulation testing, sex steroid levels, an oral glucose tolerance test~          (OGTT) and fasting lipid profile to evaluate for concomitant endocrinopathy, prediabetes~          and impaired glucose tolerance in a cohort of BMT survivors.~        2. Cross-sectional study of peripheral and hepatic insulin sensitivity in children~          surviving BMT using a hyperinsulinemic euglycemic clamp and the stable isotope 6,6 [2H2]~          glucose. These aims will provide pilot data to power the first definitive study of~          insulin resistance in childhood BMT survivors.~   "
206737|NCT00855231|"~     The ACUTE CT trial is designed to test whether the assessment of chest structures by~     high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy~     for patient with acute chest pain or other potential cardiac symptoms as compared to a~     standard of care evaluation.~   "
206738|NCT00855218|"~     This study will look at whether our drug (sorafenib) in combination with chemotherapy~     delivered directly into your tumor using beads (DC Bead) will slow the progression of the~     disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing~     the adverse effects that normally occur with chemotherapy.~   "
206739|NCT00855205|"~     Sarcoidosis is a inflammatory disease affecting many parts of the body, especially the lungs.~     While most patients do well, there is a group of patients who require continuous doses of~     prednisone or other drugs. The current study will determine the role of Rituximab as new~     agent for patients with refractory disease.~   "
206740|NCT00855192|"~     Approximately 20% of pregnant women experience depression. Untreated depression during~     pregnancy is linked to decreased prenatal care, difficulties in the pregnancy, poorer~     outcomes for the baby, and developmental, language, and behaviour problems in the older~     child.~      While medication can often offer relief, pregnant women suffering with depression are often~     reluctant to take medications that may affect the unborn baby. There is little research about~     the effectiveness of other treatments such as support groups.~      The investigators project will provide relaxation groups for pregnant women with anxiety and~     depression. The group will provide a chance to get support from other pregnant women. Two~     health care specialists will provide information about anxiety and depression. They will also~     teach the skills for women to manage their symptoms. Women will be asked to complete a few~     questionnaires to evaluate their symptoms before, during, and after they join the group. They~     will also be asked to evaluate how the group met their needs.~   "
206741|NCT00855179|"~     To assess the efficacy and tolerability of Antistax film coated tablets in patients with~     chronic venous insufficiency (CVI, CEAP Classification: Clinical class 3 and 4a).~   "
206742|NCT00855166|"~     This study is being carried out to see if dapagliflozin in addition to metformin decreases~     body weight and if so, how it compares with metformin alone.~   "
206743|NCT00855153|"~     The purpose of this pilot study is to begin the examination of the feasibility of using~     Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) in the management of~     posttraumatic psychological symptoms in burned OIF/OEF military combatants.~      The purpose of a feasibility study is to determine if there is clinical utility in this~     proposed treatment and to establish effective and safe treatment procedures. Given current~     literature, the following hypotheses are generated:~      Hypothesis 1: Virtual Reality Exposure and D-Cycloserine medication (VRE + DCS learning pill)~     will result in clinically meaningful PTSD symptom reduction.~        1. SMs will attain scores that are lower than initial measures for symptoms of PTSD~        2. By the completion of VRE, Ss will attain scores in the sub-clinical range for measures~          of clinical depression Hypothesis 2: SMs will report greater life satisfaction following~          completion of VR+DCS treatment, as measured by scores on the Quality of Life Inventory~          (QOLI) when compared to pre-treatment scores~   "
206744|NCT00855140|"~     Insomnia is a common and disabling condition associated with psychiatric and medical~     comorbidities and often persists despite currently available treatments. Acupuncture has been~     reported to benefit individuals with insomnia and can decrease hyperarousal. This blinded RCT~     will investigate the impact of a standardized acupuncture protocol on insomnia, daytime~     symptoms, and hyperarousal.~   "
206745|NCT00855127|"~     The purpose of this study is to find new blood and urine tests that detect acute kidney~     injury earlier than our current blood tests in patients receiving a liver transplant.~   "
206746|NCT00855114|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well everolimus works in treating women with~     breast cancer that can be removed by surgery.~   "
206748|NCT00855088|"~     This study is being conducted to look at how the body handles the drugs darunavir and~     etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in~     the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the~     reproductive and intestinal tracts. It is believed that the presence of this drug in these~     areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person~     to another. The study will take samples of blood, semen and rectal mucosal tissue to measure~     drug levels. This study will also collect information on side effects.~   "
206749|NCT00855075|"~     The purpose of this study is to correlate the cerebral state index obtained from a cerebral~     state monitor with the Richmond Agitation-Sedation Scale assessment performed on sedated and~     mechanically ventilated intensive care patients.~   "
206750|NCT00855062|"~     Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline,~     an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive~     impairment in Uganda.~      Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with~     Optional 24-week Open Label Phase for Subjects with a cluster of differentiation 4 (CD4)~     Count in the 251-350 Range~        -  Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects)~        -  Arm 2: Matching placebo orally every 12 hours (50 subjects)~      Primary Objective:~      · To examine whether minocycline treatment will improve cognitive performance after 24 weeks~     compared to baseline~      Secondary Objectives:~        -  To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in~          individuals with HIV-associated cognitive impairment~        -  To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in~          individuals with HIV-associated cognitive impairment~        -  To examine whether minocycline treatment for 24 weeks improves functional impairment~   "
206751|NCT00855049|"~     This study is being done to determine the systemic absorption of nasally inhaled~     acetaminophen (Tylenol®) versus orally ingested acetaminophen by comparing the serum drug~     concentrations of the two groups obtained at various times after study drug administration.~   "
206752|NCT00855036|"~     The objective of this study is to evaluate the outcomes of children who have sustained blunt~     renal injury and to evaluate our current bed rest protocol. The variables of concern are~     readmission, operation, subsequent hypertension and clearance of hematuria. The specific aim~     of the study is to prospectively collect the clinical data of these children to validate our~     hospital management and to define the natural history of these lesions.~   "
206753|NCT00855023|"~     This study evaluates the the anatomic factors of the knee that may predispose to ACL injury.~   "
206754|NCT00855010|"~     Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on~     pancreatic fat content and bone turnover markers.~   "
206755|NCT00854997|"~     Objective: Untreated OSA is associated with three fold risk of fetal and non-fetal~     cardiovascular events than control subjects in the long-term follow up. However, the~     prevalence rate and impact of OSA in patients with acute myocardial infarction (AMI) was not~     clear so far. The conflicts of studies come from variable period of AMI, heart function at~     enrollment, techniques used to diagnose OSA, time to revascularization, and target endpoint.~     Therefore, this project aimed to study the patients of first-time, Killip I-II, and post~     primary percutaneous coronary intervention (PCI) AMI in both and chronic phase to achieve~     four goals:~      Aim 1. To determine the prevalence rate of OSA in patients with first-time AMI The acute~     phase of AMI was defined as within 14 days of the onset of AMI and the chronic phase was~     defined as > 14 days of onset. Eligible patients were screened with polysomnography within~     5th to 7th days and 6th months of AMI to determine the prevalence rate of OSA in the AMI.~     Patients who had AHI more than 15/hr were considered as suffering from OSA.~      Aim 2. To identify the clinical characteristics and risk factors in AMI patients associated~     with OSA Patients were followed up at clinics for five years. The baseline demographics of~     patients with or without OSA were compared to determine the factors associated with OSA in~     AMI patients.~      Aim 3. To study the impact of OSA on the prognosis of AMI patients after revascularizaton The~     primary endpoint was mortality rate and cardiac events. The secondary endpoint was left~     ventricular function and variables related to cardiovascular disease (CVD) and metabolic~     syndrome. The impact of OSA on AMI was determined by comparing primary and secondary endpoint~     between AMI patients with and without OSA.~      Aim 4. To identify the clinical and molecular factors attributing to AMI in OSA patients~     Factors attributing to AMI in OSA patients were determined by comparing the clinical data and~     mRNA expression of angiogenesis and other related genes in OSA patients with the acute phase~     of AMI and patients without major CVD.~   "
206756|NCT00854984|"~     A feasibility pilot trial of the self-help, Cognitive behavioural therapy based Living~     Life to the Full Materials for use by patients with diabetes type 2 and / or coronary heart~     disease.~   "
206757|NCT00854971|"~     The purpose of this study is to determine efficacy of NKCell in colorectal cancer~   "
206758|NCT00854958|"~     Oral allergy syndrome is a type of food allergy which mainly affects people with springtime~     hay fever. It is caused by a cross-reaction, between antibodies to pollens, usually birch~     tree pollen, and allergens in many different plant foods. It is characterised by symptoms of~     itching and/or swelling in the mouth and/or throat when eating certain fruits vegetables and~     nuts. Many of the allergens causing OAS are destroyed by heat, making allergy testing using~     traditional allergen extracts unreliable. Prick testing or challenging with fresh foods is~     more reliable, but time consuming, inconvenient and largely unavailable. Pilot study results~     suggest the characteristic symptoms and foods involved in OAS allow accurate diagnosis using~     clinical history alone, which forms the basis for the hypothesis of this proposal that OAS~     can be diagnosed accurately by use of a validated questionnaire alone. The diagnostic~     questionnaire (PFSDQ), revised from the results of the pilot study, will be tested against~     two reference test methods, the gold standard of oral food challenge, and the 'platinum~     standard' of diagnosis made by a medical expert based on history, skin prick testing and oral~     food challenge. This is not an epidemiological study but with no published studies on OAS in~     a UK population, this study will also provide some information on the prevalence of OAS in~     those with springtime hayfever in the UK.~   "
206759|NCT00854945|"~     The primary objective of this study is to evaluate the efficacy and safety of ON 01910.Na~     Concentrate when it is administered as an intravenous continuous infusion (IVCI) over 72~     hours once every 2 weeks in a broad population of MDS patients. Rationale for this study is~     based on the activity observed in another study with ON 01910.Na in patients with refractory~     anemia with excess blasts (RAEB) 1 and 2 MDS. This study will examine ON 01910.Na in a~     broader population of MDS and AML patients. This phase I/II study will establish the Maximum~     Tolerated Dose (MTD) starting with a dose of 800 mg/m2 per day administered over 24 hours for~     2 consecutive days as a continuous intravenous infusion, once a week for 3 weeks of a 4-week~     cycle and examine the efficacy and safety profile at the MTD.~   "
207182|NCT00849316|"~     This study is conducted in Asia. The aim of this observational study is to investigate the~     clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in~     patients with coexisting diabetes and kidney disease under normal clinical practice~     conditions in India.~   "
206760|NCT00854932|"~     In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific~     and currently available tests have poor positive and negative predictive values. The~     investigators hypothesize that procalcitonin (PCT) has a reliable negative predictive values~     to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal~     early-onset sepsis with unchanged outcome. This study is designed as a multi-center,~     prospective, randomized intervention trial. The duration of antibiotic therapy in the~     standard group is based on the attending physician's assessment of the probability of~     infection during hospitalisation. In the PCT group, if infection is considered to be unlikely~     or possible, antibiotic therapy is discontinued when two consecutive PCT values are within~     the normal range.~   "
206761|NCT00854919|"~     Objective: Although atypical antipsychotic drugs (AAPDs) have been found effective in the~     augmentation of serotonin reuptake inhibitors (SRIs) for treatment-resistant~     obsessive-compulsive disorder (OCD) in short terms trials, there are few data on the~     effectiveness and safety of these agents in clinical settings over the long term.~      Method: Subjects (n=46) who responded to selective SRIs (SSRIs) in an initial 12-week trial~     were continued on SRI-monotherapy plus cognitive-behavioral therapy (CBT) for one year.~     Subjects (n=44) who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such~     as risperidone and were consecutively treated using SSRI+AAPD combined with CBT for a year.~   "
206762|NCT00854906|"~     The purpose of the research is to determine if putting fluorescein onto the eye (most common~     test done for dry eye syndrome) is an accurate way to measure dry eye symptoms. The~     investigators can avoid placing any foreign substance into the eye by using a manual~     keratometer. Therefore, the investigators want to compare the measurements of tear breakup~     time using fluorescein with using a novel method, a manual keratometer and then compare these~     measurements to a validated dry eye symptoms questionnaire. All qualifying patients who were~     scheduled in the Jones Eye Institute Clinics for a complete eye exam were offered information~     about the study and invited to participate. Participants were recruited from February 29,~     2009 to April 14, 2009.Participants who did not meet the study protocol's inclusion and~     exclusion criteria were not included the study or study data analysis. All subjects eyes were~     measured for KTBUT and FTBUT.~   "
206763|NCT00854893|"~     The purpose of this study is to test the effect of transcranial direct current stimulation~     over the motor cortex of the language dominant hemisphere on language learning in healthy~     subjects and stroke patients with aphasia. We hypothesize that anodal stimulation enhances~     the learning of action words compared to sham and cathodal stimulation.~   "
206764|NCT00854880|"~     The objective of this trial is to evaluate the efficacy and safety of PDC-339 in the~     treatment of acute erosive gastritis, using placebo as the comparator.~   "
206765|NCT00854867|"~     The purpose of this study is to demonstrate the safety of giving Whole Brain Radiotherapy~     (WBRT) together with intrathecal liposomal cytarabine (DepoCyte®) for patients with~     leptomeningeal metastases. The study will compare the safety of giving DepoCyte at the same~     time as WBRT with giving the drug after WBRT is complete.~   "
206766|NCT00854854|"~     The purpose of this study is to determine efficacy of NKCell combined FOLFOX-4 chemotherapy~     in gastric cancer~   "
206767|NCT00854841|"~     Research Hypothesis:~      Treatment with dasatinib 100 mg QD is superior to imatinib 600 mg QD in terms of complete~     cytogenetic response (CCyR) in chronic phase (CP) Philadelphia chromosome-positive (Ph+)~     Chronic Myeloid Leukemia (CML) subjects who are imatinib failures or who have achieved only a~     suboptimal response after 3-18 months (12-77 weeks) of therapy with imatinib 400 mg.~      Primary Objective:~      The primary objective of this study is to compare the rate of CCyR of dasatinib (100mg QD) to~     high-dose imatinib (600 mg QD) therapy at 6 months after randomization in CP Ph+ CML subjects~     who are imatinib failures or who have achieved only a suboptimal response after 3 - 18 months~     of imatinib monotherapy at 400 mg/day.~   "
206768|NCT00854828|"~     This is a multicenter study evaluating the effectiveness of nonoperative and operative~     treatments. The investigators wish to identify important clinical and radiographic~     determinants of outcomes in the management of adults with symptomatic lumbar scoliosis~     (ASLS).~      Note: Enrollment was complete July 2014. NIAMS funding ended 2/28/17. We continue to follow~     enrolled subjects while we seek additional funding to follow all subjects through 8 years.~   "
206769|NCT00854815|"~     The purpose is to quantify the effect of irrigation during laparoscopic appendectomy for~     perforated appendicitis.~   "
206770|NCT00854802|"~     The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin~     triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis~     C genotype 1 patients.~   "
206771|NCT00854789|"~     The objectives of this study are the following:~        1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75)~          in node-negative breast cancer patients.~        2. To determine the optimal dose of the immunoadjuvant, GM-CSF, necessary to elicit an in~          vivo cellular immune response to the peptide vaccine yet limit toxicity.~        3. To determine the optimal inoculation schedule to elicit an in vivo cellular immune~          response to the peptide vaccine.~        4. To correlate the efficiency of eliciting an in vivo cellular immune response to the~          peptide vaccine with the degree of HER2/neu expression in the patient's tumor.~   "
206772|NCT00854776|"~     Studies showed that combined use of clopidogrel and aspirin had a 25 % reduction of risk on~     myocardial infarction and stroke in patients who undergone percutaneous coronary intervention~     (PCI) when compared with use of aspirin alone. However, major GI bleeding rose in combined~     group than aspirin group. Use of proton pump inhibitor (PPI) which diminishes gastric acid~     secretion effectively reduces aspirin or clopidogrel associated ulcer or/and ulcer bleeding~     in general population and high risk patients. The investigator hypothesis is whether use of~     PPI can reduce ulcer and ulcer complication in patients taking both clopidogrel and aspirin.~   "
206773|NCT00854763|"~     We will conduct an open label, non-comparative, observational study to evaluate the efficacy,~     safety and tolerability of Olmesartan therapy in Taiwan patients with essential hypertension,~     and the primary objective is the change in the 24-hour mean systolic blood pressure from~     baseline to the day after post-treatment week-12 visit according to the ambulatory blood~     pressure monitoring.~   "
208799|NCT00827944|"~     The objective of the study is to evaluate pain and disabling complications inducing social~     consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair~     with lightweight polypropylene mesh.~   "
206774|NCT00854750|"~     The investigators principal hypothesis is that INO and optic neuritis are objective,~     quantitative, and reproducible models for corroborating the hypothesis that changes in core~     body temperature are associated with the reversible and stereotypic decay in axonal~     conduction and that ACTHAR can serve to prevent such changes. The application of ocular motor~     and optic nerve measures appears to constitute a useful paradigm to detect and monitor~     responses to therapeutic strategies that stabilize nerve cell membranes in response to~     temperature induced decay in axonal conduction mechanisms, with implications on activities of~     daily life that are dependent upon vision (reading, driving, walking, work performance).~   "
206775|NCT00854737|"~     The goal of the proposed clinical trial is to assess the effect of oral cytidine and omega-3~     fatty acids (O3FA) on bipolar disorder symptoms. This study is a 4-month, randomized,~     parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and~     omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. During the 16 week~     period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids +~     cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo~     supplementation.~   "
206776|NCT00854724|"~     This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a~     major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment~     with this compound will reduce alcohol self-administration in a simulated natural settings~     laboratory.~   "
206777|NCT00854711|"~     Reperfusion of ischemic myocardium, termed ischemia/reperfusion during the treatment of MI~     may result in paradoxical myocardial injury compromising myocardial salvage and left~     ventricular functional recovery. Nitric oxide (NO) modulates many of the processes~     contributing to ischemia-reperfusion injury (IR)and inhaled NO (iNO) has been shown to~     decease infarct size in animal models of IR. iNO has been studied in various clinical~     settings and has shown promise im modulating the detrimental effects of IR. Clinical toxicity~     potentially associated with the use of iNO was of no apparent concern in these studies.~     Although controlled trials of iNO therapy in humans with acute MI have not been published,~     anecdotal experience indicates a beneficial impact of iNO on the hemodynamic course of~     patients with right ventricular MI. iNO is widely used to treat neonatal hypoxemia and acute~     pulmonary hypertension. iNO has been studied at this dose in various clinical settings and~     side effects related to its use at such doses are extremely uncommon. The effect of iNO on IR~     injury in patients with acute ST-segment elevation MI is unknown. The investigator intend to~     perform a prospective, randomized, placebo-controlled, clinical trial of iNO in patients with~     acute MI undergoing primary percutaneous intervention to determine whether this form of~     therapy can decrease infarct size and improve clinical outcomes.~   "
206778|NCT00854698|"~     The real impact of the existence of an aortic valve mismatch after aortic valve replacement~     in various studies conducted so far is a source of controversy. There is currently no~     long-term impact of the aortic valve mismatch on the reversal of left ventricular remodeling~     and its impact functional.To evaluate these effects of aortic valve mismatch on abilities to~     the effort, the quality of life and the regression of left ventricular hypertrophy long term~     after a aortic valve replacement, conducting a new study is fundamental. This study is even~     more essential in patients with a young life expectancy theoretical long and physical~     activity.Our study aims to determine whether the existence of an aortic valve mismatch has an~     influence on: The functional capacity to the effort by measuring the maximum oxygen~     consumption during a stress test (VO2 max) The reversal of left ventricular remodeling~     (cardiac ultrasound doppler), diastolic dysfunction (cardiac ultrasound and Doppler~     measurement Brain Natriuretic Peptide (BNP). This study will analyse these data in patients~     who received youth a VAN by mechanical aortic valve prosthesis.~   "
206779|NCT00854685|"~     The purpose of this clinical trial is to establish what dose level and dosing frequency is~     optimal in the treatment of rheumatoid arthritis patients with ART621.~   "
206780|NCT00854672|"~     The aim of this study is to examine exercise capacity, muscle strength and fatigue in~     sarcoidosis. In this longitudinal study the changes in prevalence of exercise intolerance,~     reduced muscle strength and fatigue will be established in a two-year follow-up. Also the~     relation between these physical impairments in time and other clinical parameters, such as~     QOL, will be established.~   "
206781|NCT00854659|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     three different strengths of an investigational product dosed twice a day over 7 days in~     healthy subjects.~   "
206782|NCT00854646|"~     This is an open-label, Phase I study to determine the highest amount of the study drug, ON~     01910.Na, that can be safety given to patients with high risk myelodysplastic syndromes (MDS)~     or refractory leukemias. Patients will receive ON 01910.Na (at a starting dose of 650 mg/m2)~     intravenously by 3-day continuous infusion once every 2 weeks. Successive courses will use~     longer infusion times and/or higher doses of the drug until toxicity, effectiveness, or~     ineffectiveness is recognized. In addition, the amount of drug in the blood will be measured,~     any antitumor activity will be documented, and the biological effect of ON 01910.Na on~     cell-cycle pathways will be evaluated in peripheral blood mononuclear cells.~   "
206783|NCT00854633|"~     This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the~     incidence of all nosocomial infections in prematurely-born infants.~   "
206784|NCT00854620|"~     Determine time-to-progression (TTP) for an escalating dose schedule for subjects with~     progressive metastatic renal cell carcinoma treated with sorafenib~   "
206785|NCT00854607|"~     The purpose of this study is to evaluate the relationship between fungal biomarker levels~     during anti-fungal therapy and the success of treatment for fungal infection. The primary~     hypothesis is that over the initial two weeks of anti-fungal therapy, fungal biomarkers from~     participants with invasive aspergillosis (IA) will be lower for those with a successful~     clinical outcome compared to those with a failed clinical outcome.~   "
206786|NCT00854594|"~     The investigators' study focuses on improving the care of diabetes, a complex chronic~     illness, by providing important insights into interprofessional training and its potential~     role in fostering the necessary interdisciplinary management needed for chronic conditions~     and in addressing the gap between best practice and actual care provided.~   "
210907|NCT00800072|"~     The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX,~     under usual conditions of daily living, in patients with chronic obstructive respiratory~     disease requiring oxygen therapy.~   "
206787|NCT00854581|"~     RATIONALE: Human T-cell lymphotropic virus type 1 (HTLV-1) can cause cancer. Zidovudine is an~     antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving~     zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune~     system and slow down or keep the cancer cell from growing.~      PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon~     alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic~     virus type 1-associated adult T-cell leukemia/lymphoma.~   "
206788|NCT00854568|"~     The aim of this study is to compare CHOP versus CEOP-induced cardiotoxicity in patients with~     aggressive B-cell lymphoma. The hypothesis is epirubicin is associated with less~     cardiotoxicity without compromising the efficacy.~   "
206789|NCT00854555|"~     The ATLET study will assess the effect of manual or robotic body-weight supported locomotor~     training of patients with stable motor incomplete spinal cord injury (SCI) on gait and~     overall ADL function as well as on estimated health care costs.~   "
206790|NCT00854542|"~     Hypothesis 1. Telepsychiatry consultations will be acceptable and well-received by depressed~     Chinese Americans and by their primary care clinicians.~      Hypothesis 2. Depressed Chinese Americans in remote primary care clinics receiving T-CSCT~     will have improved outcomes compared to patients who receive Usual Care by primary care~     physicians.~   "
206791|NCT00854529|"~     Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery~     creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.~      A rather common adverse event of the surgery is increasing vascularity of the conjunctiva~     overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and~     finally failure of the bleb (and of the surgery) this study intends to demonstrate that post~     operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and~     ultimately, bleb failure.~   "
206792|NCT00854516|"~     To assess the safety of a new compression device applied to patients with an ankle brachial~     pressure index (ABPI) 0,5 - 0,8 who are treated for two weeks in daily routine practice.~     Several perfusion assessments will investigate safety under reduced compression therapy.~   "
206793|NCT00854503|"~     Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia,~     promotes the development of coronary heart disease. Secondary dyslipidemia is often~     associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase~     inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading~     to a significant reduction of cardiovascular risk. More recently, revisions to guidelines~     have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring~     the administration of higher dose of statin. However, it is unclear whether high dose statin~     therapy could affect glycemic control in diabetic patients. Moreover, data regarding the~     effects of statins on insulin-resistance and endothelial function are controversial.~   "
206794|NCT00854490|"~     The purpose of this study is to evaluate the long-term clinical significance of~     small-intestinal mucosal injuries in chronic NSAIDs-users.~   "
206795|NCT00854477|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of adjuvant capecitabine~     in patients who have undergone proximal pancreatico-duodenectomy.~   "
206796|NCT00854464|"~     1. To investigate the relationship between arsenic methylation enzymes (AS3MT, PNP,GSTO1,~          and GSTO2) genetic polymorphism and UC risk.~        2. To explore the relationship between cigarettes metabolites (NNK, NNAL, HBA, NNAL-Gluc,~          O6-Methylguanine, and N7-Methylguanine) and UC risk.~        3. To examine the relationship between cigarette metabolic enzymes (CYP2A6, CYP2A13, and~          UGT2B7) genetic polymorphism and UC risk.~        4. To elucidate the relationship between DNA repair enzymes (MGMT, XPD, XRCC1, and XRCC3)~          gene polymorphism and 8-OHdG or between DNA repair enzymes and UC risk.~        5. To examine relationship between COX-2 (-1195G/A、-765G/C 和8473C/T), IL-6, IL-8, and TNF-α~          gene polymorphism and 8-OHdG or between COX-2, IL-6, IL-8, and TNF-α gene polymorphism~          and UC risk.~        6. To examine the risk factors of the environment-environment, gene-environment, and~          gene-gene interaction on the risk of UC.~   "
206797|NCT00854451|"~     The aims of this study are (1) to evaluate the prevalence rate of PM of CYP2C19 in our~     country; (2) to evaluate the efficacy of dual therapy with different dose of omeprazole and~     amoxicillin; (3) to judge the relationship of genotype of CYP2C19 and the eradication rate of~     dual therapy in the peptic ulcer patients; (4) to try to find out a predictor of success of~     dual therapy and an optimal dose of dual therapy as first-line and rescue anti-Helicobacter~     pylori regimen.~   "
206798|NCT00854438|"~     Thesis: Is drug-induced anticholinergic activity additive resulting in a total~     anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to~     reduce the anticholinergic load by multidisciplinary medical review including a pharmacist~     and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and~     CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity,~     activity of daily living and neuropsychiatric symptoms.~      Design: A randomized, controlled, single blinded interventional study in Norwegian nursing~     homes.~   "
206799|NCT00854425|"~     The purpose of this study is to evaluate the efficacy and tolerability of L-asparaginase~     monotherapy as salvage treatment in patients with NK/T cell lymphoma~   "
206800|NCT00854412|"~     High levels of mannose-binding lectin (MBL), an activator of a part of the immune system~     called the complement system, have been associated with increased mortality and risk of early~     signs of kidney damage in patients with type 2 diabetes. The effect of weight loss and~     changes in insulin resistance on MBL levels have been poorly elucidated.~      This study includes 36 nondiabetic obese subjects, who will receive a very low- calorie diet~     (VLCD) of 800 kcal/day for 8 weeks.~      Fasting blood samples will be obtained at baseline and after 8 weeks of VLCD and~     concentrations of MBL, glucose and insulin will be measured. Insulin resistance is assessed~     using the HOMA-IR method.~   "
206822|NCT00854126|"~     This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and~     pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with~     incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or~     failed to respond to at least one prior regimen or for which there is no standard therapy.~   "
206823|NCT00854113|"~     This study evaluated the safety, tolerability and pharmacokinetics of single or multiple~     doses of EGT0001474.~   "
206801|NCT00854399|"~     Ovarian cancer is the first mortality rate of gynecologic malignancies. The incidence of~     ovarian cancer increased in recent 10 years and it has become the ninth cause of malignancies~     in the women in Taiwan. From the above-mentioned data, ovarian cancer indeed is a disease~     that should be respected, however, there were only few of research work focusing on it in~     Taiwan. Despite the widespread use of aggressive cytoreductive surgery and the introduction~     of chemotherapy regimens, the overall survival has changed little over the last two decades.~     The basic problem in treating epithelial ovarian cancer is that once it has spread beyond the~     ovary, it is exceedingly difficult to control and ultimately to cure. More than 70% of~     ovarian cancer patients were advanced stage when diagnosed. To study the mechanisms of~     carcinogenesis, progression, and metastasis of ovarian cancer will help us understand this~     disease and develop new treatment strategies for ovarian cancer in the future.~      We have established an ascites-generating intraperitoneal tumor cell line-WF3 in the mouse~     model in our previous two-year project of NSC grant (grant number (NSC90-2314-B-002-457 and~     NSC91-2341-B-002-315). Our group found that, mesothelin, this molecule is highly related with~     the carcinogenesis, tumor progression and tumor metastasis in our animal model and human~     cancer tissues. To further evaluate the role of mesothelin in ovarian cancer and elucidate~     the potential of mesothelin as a target antigen for immunotherapy,~   "
206802|NCT00854386|"~     The objective of this study is to compare the effects of two intraoperative fluid regimens -~     restrictive versus liberal (standard)- on postoperative outcomes (e.g. cardiopulmonary~     complications, morbidity, mortality and duration of hospitalization) in lung resections via~     Video-assisted thoracic surgery (VATS).~   "
206803|NCT00854373|"~     Marcelle Cedars, M.D., Victor Fujimoto, M.D., Mitch Rosen, M.D., Heather Huddleston, M.D.,~     Paolo Rinaudo, M.D., Anthony Dobson, M.D., and Shehua Shen, M.D. from the UCSF Department of~     Obstetrics and Gynecology and Reproductive Sciences are conducting a study to learn about~     ovarian stimulation and oocyte maturation to improve fertilization, embryo quality,~     implantation and clinical pregnancy rates in patients undergoing in vitro fertilization~     (IVF). Two hormones, follicle stimulating hormone and human chorionic gonadotropin (FSH/hCG)~     will be compared to the standard one hormone, hCG, for the ovulation trigger.~      Over the past two decades, the success rate of assisted reproductive technology (ART) has~     dramatically increased. This increase has largely been attributed to improvements in the~     laboratory conditions and improvements in ovarian stimulation protocols (those medications~     used to increase the number of eggs maturing each cycle). Less work has been done on~     different ways to cause the final maturation of the eggs and the release of the egg from the~     ovary. The investigators propose to change the final injection prior to the egg retrieval~     (the ovulation trigger) so that it looks more like what happens in a normal menstrual cycle,~     where two hormones (both luteinizing hormone (LH) and FSH) increase. The investigators want~     to find out if this will improve egg quality and increase chances for pregnancy.~   "
206804|NCT00854360|"~     This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week,~     multi-center, dose-range-finding study in male or female patients (12 years and older) with~     SAR.~   "
206805|NCT00854347|"~     Hyperglycemia is very common among critically ill patients, even in the absence of diagnosed~     diabetes or pre-diabetes.~      We aimed to determine the prevalence of occult glucose metabolism abnormalities in a general~     intensive care unit (ICU) and hypothesized that hyperglycemia severity, as reflected by~     insulin requirements for maintenance of normoglycemia, could be used as a tool to identify~     high risk patients.~   "
206806|NCT00854334|"~     Rationale: Obesity is an increasing childhood epidemic in Canada. Obstructive sleep apnea~     (OSA) is a complication of obesity which causes cardiovascular disease, reduced quality of~     life, and premature death. While the complex interactions between obesity and OSA are not~     entirely clear, we hypothesize that these conditions may compound each other by:~        1. decreasing physical activity and total energy expenditure by reducing both non-exercise~          physical pursuits (NEAT- non-exercise activity thermogenesis) and purposeful physical~          activity.~        2. alterations in the secretion of appetite-controlling hormones, which may lead to~          increases in energy intake.~      Objective: To determine whether the presence of both obesity and OSA in children is~     associated with a decrease in physical activity and alterations in appetite-regulating~     hormones greater than those seen in either condition alone or compared to controls.~      Methods: Comparison of children 10-17 years with obesity and OSA, obesity alone, OSA alone~     and neither condition, for the following outcomes: (1) NEAT (kcal/day) (2) Physical activity~     behavior, appetite regulating hormone profile and self-report appetite assessment.~      Unique Aspects: This study combines expertise in sleep medicine, exercise physiology and~     obesity. Conclusions from this study will better characterize this high-risk clinical~     population so that innovative strategies targeting improvements in lifestyle behaviors can be~     developed.~   "
206807|NCT00854321|"~     One centre follow-up study on safety and efficacy of treatment with rituximab among patients~     with RA during 4 year period. Basic data is collected for the national register of~     biologicals.~   "
206808|NCT00854308|"~     This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily~     evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib +~     placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will~     be randomized in a 1:1 ratio to one of the two treatment arms.~   "
206809|NCT00854295|"~     The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile~     Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.~   "
206824|NCT00854100|"~     This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on~     therapy to standard antidepressants in patients who did not respond to previous~     antidepressant therapy.~   "
206852|NCT00853736|"~     The objective of this open-label, randomized, two-period crossover study was to compare the~     oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an~     equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane~     Laboratories, Inc.) in a test group of healthy subjects under fed conditions.~   "
206866|NCT00853554|"~     The objective of this open-label, randomized, two-period crossover study was to compare the~     oral bioavailability of a Mallinckrodt test tablet formulation of hydromorphone 8 mg to an~     equivalent oral dose of a commercially available hydromorphone tablet (DILAUDID® 8 mg, Knoll~     Pharmaceutical Company) in a test group of healthy subjects under fasting conditions.~   "
206810|NCT00854282|"~     Cancer is the leading cause of mortality in our country, and ovarian cancer becomes a more~     and more important disease gradually in the field of gynecologic malignancies. According to~     the statistics of the Department of Health, the incidence of ovarian cancer increased in~     recent years and the mortality rate was the highest among all gynecologic malignancies in~     Taiwan. Early diagnosis for ovarian cancer is difficult due to the lack of obvious and~     specific initial symptoms. Therefore, it is usually at advanced stage when the diagnosis is~     confirmed. The prognostic parameters for ovarian cancer include tumor stage, histological~     subtype and grade, residual tumor after surgical intervention and the response to~     chemotherapy. However, the possible mechanism of ovarian cancer is still not clear now, which~     has considerable influence on the management and prognosis of the patients.~      Malignancy is considered as a multi-factorial disease, and the influence of immunologic~     mechanism on progression and prognosis of cancer is more and more important. The natural~     CD25+CD4+ regulatory T cells actively suppress pathologic and physiological immune response,~     contributing to the maintenance of immunological self-tolerance and immune homeostasis. The~     development and function of regulatory T cells depend on the expression of the transcription~     factor forkhead box P3 (FOXP3). The mechanisms of suppression are still not known well.~     Whatever the mechanisms of suppression are, it is necessary to control the magnitude of~     regulatory T cells-mediated suppression for the benefit of the host because too much~     suppression might lead to immunosuppression and render the host susceptible to infection and~     cancer.~      We will collect the tumor tissue, ascites and peripheral blood during operation. Through this~     research we will set up the immunological profiles in the changes of lymphocytes, humoral~     immunity and cell-mediated immunity in ovarian cancer patients. The kinetic changes and~     associations between regulatory T cells and the severity and progression of disease will also~     be evaluated. Therefore, the role of regulatory T cells would be defined in the patients with~     ovarian cancer. We will also correlate the regulatory T cells with the clinical prognosis of~     ovarian cancer patients. Finally, we will try to find an efficient therapeutic strategy for~     the cancer patients.~   "
206811|NCT00854269|"~     Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of~     the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women~     worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been~     consistently implicated in causing cervical cancer especially those high-risk types (HPV~     16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are~     infected by HPV within their whole lives. However, only 1% of HPV-infected women have~     cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host~     immune responses within 1 and 2 years later. It shows that host immunity plays an important~     role in the progression, persistence, or regression of HPV infection.~      There are two main defense lines in the host immunity including innate immunity and adoptive~     immunity. Adoptive immunity plays more important roles in the defense of HPV infections than~     innate immunity. The adoptive immunity could be further divided into humoral immunity and~     cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate~     memory B cells to produce antibody which provide the protective function to HPV infection.~     Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific~     cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches~     focused on the immunity to HPV infection, there is no conclusion about the relationship~     between humoral and cell-mediated immunities on HPV infection and roles of humoral and~     cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer~     patients.~      Our research team has focused on the establishment of platforms on cell-mediated immunity to~     HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected~     population and cervical cancer patients for years. In order to survey the host immunity to~     HPV infection more comprehensively, we propose this 3-year proposal. First, we would like to~     set up the platforms to survey the humoral immunity to HPV infection in normal population and~     patients with CIN lesion or cervical cancer. Second, we would to elucidate the correlation~     between humoral immunity and status and clinico-pathologic items of HPV-infected populations.~     Third, we would like to survey if the humoral immunity correlate with the prognosis of~     patients with cervical lesions. Fourth, we would like to elucidate the correlation betweenHLA~     haplotype and humoral immunity in HPV-infected populations. Our research results will have a~     more comprehensive overview in the host immunity to HPV infection and its related diseases.~     It could provide more information in the prevention and treatment of HPV infection in the~     future.~   "
206812|NCT00854256|"~     The aim of the study is to investigate pressure lowering effect of two surgical methods~     canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local~     pressure lowering therapy the progression of the disease could not be stopped, and thus a~     pressure lowering surgical intervention is necessary. The risks in the postoperative course~     in Canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-C.~     Conversely, large glaucoma centers questioning the effectiveness of permanent pressure~     lowering of canaloplasty. Precisely this question is investigated in the study.~   "
206813|NCT00854243|"~     The purpose of this study is to evaluate the role of musculoskeletal ultrasound and power~     Doppler in early therapy monitoring of rheumatoid arthritis patients.~   "
206814|NCT00854230|"~     This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV~     infected heavy drinkers. The study will select 40 HIV positive patients who meet criteria for~     heavy drinking. Treatments include Naltrexone (25-100mg)and placebo. Patients will be~     treated, followed up, and assessed for a duration of 12 weeks.~      The investigators associated hypotheses Hypothesis 1: Naltrexone will reduce the frequency of~     heavy drinking. Hypothesis 2: Naltrexone will lead to maintenance or improvement in CD4~     lymphocyte count and decreased HIV RNA levels.~      Hypothesis 3: Naltrexone will lead to a reduction in sexual risk behaviors. Hypothesis 4:~     Naltrexone will lead to improved adherence to HAART. Hypothesis 5 (Exploratory): Naltrexone~     will be well-tolerated with minimal side effects and patients will exhibit good treatment~     retention.~   "
206815|NCT00854217|"~     Several studies have highlighted the cardioprotective effects of acute normovolemic~     hemodilution during cardiac surgery. The aim of our study is to show that an increase in~     endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute~     normovolemic hemodilution against ischemia-reperfusion phenomena.~   "
206816|NCT00854204|"~     The purpose of this study is to compare the bioavailability (the degree to which a drug~     becomes available in the body after administration) of 3 different pharmaceutical~     preparations of a combination of two drugs, TMC114 and TMC41629. There will be 1 single oral~     intake (intake by mouth) of each of the 3 preparations. The study will also investigate the~     safety of use and the potential side effects of TMC114 and TMC41629, and determine the~     circulating levels of both compounds in your blood over time (pharmacokinetics), after a~     single intake.~   "
206817|NCT00854191|"~     In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees~     during the first 3 months of usual ERCP training.~   "
206818|NCT00854178|"~     The purpose of this study is to evaluate if the anesthetics propofol and isoflurane can~     damage DNA, induce apoptosis, change expression of genes related to apoptosis and DNA repair~     and change cytokines profile in patients submitted to elective surgery.~   "
206819|NCT00854165|"~     Survival after cadaveric lung transplantation in recipients depended on ventilation support~     prior to transplantation has been reported to have relative high surgical mortality and~     morbidity rate. The objectives of this study were to describe the short-term outcomes of~     bilateral sequential lung transplantation under extracorporeal membrane oxygenation (ECMO)~     support in a consecutive series of patients who depended on noninvasive and invasive~     ventilation support preoperatively .~   "
206820|NCT00854152|"~     This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and~     pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with~     incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or~     failed to respond to at least one prior regimen or for which there is no standard therapy.~   "
206821|NCT00854139|"~     The primary objective is to cure multiple myeloma with less toxic allogeneic bone marrow~     transplantation while inducing renal allograft tolerance through mixed chimerism in patients~     with end stage renal failure and multiple myeloma~   "
206825|NCT00854087|"~     Current treatment of chronic liver disease relies upon removing the primary insult to the~     liver (e.g., alcohol) or treating the underlying viral infection (HBV, HCV, etc.). However,~     in the case of hepatitis C, a significant number of individuals will not clear the virus with~     current approved standard antiviral therapy, leaving them no options to manage their hepatic~     fibrosis, which can progress to cirrhosis and ultimately hepatocellular carcinoma (HCC).~      Fuzheng Huayu has been used in numerous studies in China and has been found to have a~     satisfactory prophylaxis effect on the chronic liver injury and formed liver fibrosis in rats~     and humans. In addition, it enhances the degradation of liver fibrosis and protects~     hepatocytes from injury and death, manifesting as decreasing of ALT and AST, and enhancement~     of albumin level. In addition, preliminary studies indicate that the Fuzheng Huayu has a good~     safety and tolerability profile with promising efficacy.~      The number of patients failing Interferon based therapy (i.e. not achieving SVR) is~     increasing. There are no approved standard of care treatment options for this population nor~     for patients who are intolerant or unwilling to receive Interferon; thus they are at higher~     risk for the progression of fibrosis. Moreover, there are no approved therapies to treat~     hepatic fibrosis, but basic research is exploring the pathophysiological mechanisms. Fuzheng~     Huayu is easy to administer, with a good safety and efficacy profile against fibrosis.~     Therefore, the investigators propose to further study the safety and efficacy profile of~     Fuzheng Huayu in a randomized, placebo-controlled, double blind study in Chronic Hepatitis C~     patients with hepatic fibrosis who have failed prior anti-HCV therapy or are intolerant or~     refuse Interferon based therapy.~      The primary objective of this study is to establish the safety and efficacy of Fuzheng Huayu~     treatment in chronic hepatitis C subjects who have failed prior anti-HCV therapy or cannot~     receive or refused Interferon based therapy in improving liver fibrosis.~   "
206826|NCT00854074|"~     The primary goal of this study is to validate the design of the ElectroCore RMS-1100~     Resolution Motility System™ and the ability to safely place a stimulation electrode in the~     epidural space of the spine in a post-operative subject, and to evaluate the subject's~     ability to tolerate stimulation for up to 48 hours. The secondary goal is to confirm that the~     electrical signal being delivered via this electrode shows evidence of effectiveness in~     improving the functional GI motility in subjects experiencing post-operative paralytic ileus~   "
206827|NCT00854061|"~     Study of T-PRED(TM) Compared to Pred Forte(R)~   "
206828|NCT00854048|"~     Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen~     conditions.~   "
206829|NCT00854035|"~     This Phase III clinical trial will examine the efficacy, safety, and tolerability of the~     addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes Mellitus who have~     inadequate glycemic control on diet/exercise therapy and insulin monotherapy.~   "
206830|NCT00854022|"~     This study will further the understanding of the genetic events leading to the development of~     RCC; explore the genetic basis for genetic instability and how it affects cancer risk; and~     eventually provide a means of identifying a subgroup of individuals who are most likely to~     develop RCC. Such individuals may then be targeted for intervention programs such as~     chemoprevention or dietary modification.~   "
206831|NCT00854009|"~     The purpose of this study is to evaluate the safety and tolerability of single doses of~     BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is~     absorbed and eliminated.~   "
206832|NCT00853996|"~     This phase II trial is studying how well acolbifene works in preventing cancer in~     premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain~     drugs to keep cancer from forming. The use of acolbifene may stop cancer from growing or~     coming back.~   "
206833|NCT00853983|"~     The aim of this study is to show how the body absorbs, metabolises and excretes the drug~     [14C]AZD0530. As for all clinical trials, safety and tolerability of the drug will be~     evaluated.~   "
206834|NCT00853970|"~     Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery~   "
206835|NCT00853957|"~     The purpose of the study is to evaluate the BP-lowering efficacy of the combination of~     aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African~     American patients with Stage II hypertension.~   "
206836|NCT00853944|"~     Islet transplantation requires a large number of islets required to achieve insulin~     independence and the function of the transplanted islets progressively declines over time.~     Evidence from animal studies and human islets in culture suggests that increasing GLP-1~     levels could help with both of these problems. This study is designed to test this hypothesis~     using sitagliptin in a randomized clinical trial.~   "
206837|NCT00853931|"~     This is an exploratory study in which all eligible subjects are given Panitumumab according~     to the dose and schedule approved by Health Canada. The purpose of this research study is to~     determine whether the presence of certain biomarkers (substances measurable in blood, normal~     cells or tumour tissue) are associated with an increased or decreased chance of benefit from~     panitumumab.~   "
206838|NCT00853918|"~     This is a national physician mail survey examining primary care practice patterns. The~     experimental component of the study (the clinical trial) is a randomized trial of different~     monetary incentive forms and amounts for physicians invited to participate in the study. Only~     non-VA physicians will be included in this part of the study. (VA physicians are not allowed~     to receive monetary incentives.) Physicians will be randomized to receive one of four~     incentives. The main outcome measure is the response rate.~   "
206839|NCT00853905|"~     The investigators hypothesize that intracameral Triesence during glaucoma surgery will~     provide lower intraocular pressure through better control of ocular inflammation, thus~     leading to a more successful filtering procedure.~   "
206840|NCT00853892|"~     The objective of this open-label, randomized, two-period, crossover study was to evaluate the~     oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of~     oxycodone 40 mg compared to an equivalent oral dose of a commercially available~     controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group~     of healthy subjects under fasting conditions.~   "
206850|NCT00853762|"~     This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063~     (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept~     administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS).~      This extension study consists of two parts. Part A will be double blind and Part B will be~     open label. During Part A, subjects initially randomized to atacicept will continue to~     receive the atacicept dose to which they have been randomized in study 28063 (ATAMS) once a~     week subcutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive~     atacicept at 150 mg once a week subcutaneously during Part A. Once the results of ATAMS are~     available and the atacicept dose with the best benefit / risk ratio has been identified, all~     subjects will be switched to this dose and will continue the extension study open-label (Part~     B). Throughout the study, subjects and investigators will remain blinded with respect to~     initial and part A treatment allocation/dose.~   "
206841|NCT00853879|"~     This study is being conducted to assess the impact of folate and L-methylfolate on the~     progression of Parkinson's. The investigators are specifically looking for the effect of~     these nutritional supplements in Parkinson's patients who have an antibody that effects their~     body's utilization of folate. An antibody is a protein produced by the body's immune system~     to recognize foreign substances. Normally, people do not have an antibody that prevents~     folate from working properly in the brain but it appears that some people may have such an~     antibody. Folate is an important vitamin that takes part in many critical cell functions so~     an antibody that prevented it from entering the brain properly could cause or worsen certain~     neurological disorders like Parkinson's. The results of this preliminary study will help~     determine whether it is reasonable to proceed with further study of any of these supplements~     for the treatment of Parkinson's. Patients interested in participating will have a blood test~     to see if they have folate antibodies. Patients with the antibody will be eligible to further~     participate in the study. The investigators will measure the effects of folate and~     L-methylfolate on Parkinson's disease by measuring the change in your Parkinson's disease~     symptoms over three months of treatment. The investigators will also be looking at the blood~     of some individuals who do not have Parkinson's. This is called a control group and will~     allow us to compare how common the folate antibody is in the general population compared with~     the Parkinson's population.~   "
206842|NCT00853866|"~     The hypothesis of the study is that combination of reboxetine/tDCS is more effective in~     enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to~     reboxetine and tDCS alone. The protocol is designed as a within-subject, block randomized~     placebo-controlled double-blind crossover study.~   "
206843|NCT00853853|"~     This study will compare hemorrhoid surgery by comparing a sutureless heating device with the~     old standard hemorrhoid surgery. Patients will be followed closely for wound healing and~     satisfaction.~      Hypothesis: The sutureless device will be less painful for the patient and easier for the~     surgeon to perform.~   "
206844|NCT00853840|"~     The objective of this study was to estimate the effects of a single dose of vardenafil on the~     blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to~     assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.~   "
206845|NCT00853827|"~     The study will assess the change in coronary atherosclerotic disease as determined by~     intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to~     standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the~     pre-hypertensive range.~   "
206846|NCT00853814|"~     Increased access to highly reinforcing sedentary behaviors in the home such as TV and~     computers are associated with overweight in youth. Reducing these behaviors reduces~     overweight and prevents increases in overweight in youth who are at risk, likely by~     increasing physical activity and/or reducing energy intake. Reducing access to highly~     reinforcing sedentary activities frees-up time and youth must choose to reallocate their time~     between engaging in other, less reinforcing sedentary activities or physical activity.~     Neighborhood environments that provide easy access to reinforcing physical activities such as~     those at parks may result in greater increases in physical activity when access to highly~     reinforcing home sedentary behaviors is reduced. The investigators have found in 3 data sets~     of youth ranging in age from 4 to 16 years that the proportion of park and recreation area to~     residential area within ½ mile of the child's home parcel (park and recreation index)~     independently predicted the physical activity of youth. The investigators also found that~     increases in physical activity when access to sedentary behaviors were reduced for 3 weeks~     was related to park area within ½ mile of the child's home. The aim of this study is to~     decrease access to home sedentary behaviors for 4 months and determine if changes in physical~     activity habits are related to access to parks and recreation areas in the neighborhood~     environment. The investigators propose to study 128 sedentary overweight male and female~     12-14 year-old youth recruited from parcels within Erie County, New York that have a high or~     low park and recreation index. Groups will be matched on racial/ethnic distribution and~     socioeconomic status. Subjects living at low and high park access parcels will then be~     equally randomized to groups that reduce targeted sedentary behavior (TV, computer use) time~     by 50% using TV Allowance devices placed on each TV/monitor in the home or a control group~     that has the same experimental experiences including TV Allowance devices placed on each~     TV/monitor, but programmed to not limit access to targeted sedentary behavior. Subjects will~     wear both accelerometers and wrist-watch-type global positioning systems to determine changes~     in the duration and intensity of physical activity in various parcel types, including parks.~     The investigators hypothesize differential responses in physical activity and the utilization~     of parks for physical activity. The group of youth that live at parcels with high access to~     parks and that incur a 50% reduction in sedentary behavior will have greater increases in~     physical activity, number of visits to parks and will accrue greater physical activity at~     parks than youth in the other 3 treatment groups. The investigators hypothesize that the~     alterations in physical activity will be mediated by parent modeling of physical activity and~     individual differences in the motivation to be physically active. The investigators~     hypothesize that there will be a main effect of reduction in access to sedentary behaviors on~     energy and fat intake and percent overweight.~   "
206847|NCT00853801|"~     An educational intervention in the General Medicine Clinic aimed at both primary care~     providers (PCPs) and their patients with metabolic syndrome/pre-diabetes (MetSyn/PDM).~     Improving PCPs ability to detect and manage MetSyn/PDM, as measured by the increased~     incorporation of MetSyn/PDM into PCPs care plan, and increasing patients' awareness of~     healthy lifestyle behaviors results in positive patient health behaviors and outcomes.~   "
206848|NCT00853788|"~     The purpose of this study is to assess whether skin biopsy specimens from patients with~     diffuse cutaneous systemic sclerosis (dcSSc) can be used as biomarkers (measures of activity~     and type) of disease to predict response to various experimental treatments. There are~     various experimental treatments being used in the treatment of slceroderma, but there is no~     way to predict response to any given therapy. The investigators will use DNA microarray to~     analyze the changes in gene expression in skin biopsies in response to various treatments.~     Our hypothesis is that the investigators will see changes in gene expression in response to~     various treatments that will give us insight into the cause of scleroderma. The investigators~     predict that they will be able to use this information to predict which experimental~     treatments will be beneficial to individual patients~   "
206849|NCT00853775|"~     The purpose of this study is to determine whether lipoprotein(a), also called Lp(a), is a~     risk factor for cardiovascular (heart) disease. Lipoproteins are tiny particles that~     circulate in the blood. They contain cholesterol, fat, and protein in varying amounts~     depending on the body's need. Higher levels of lipoproteins in the blood can cause an~     increased risk of heart disease.~      The investigators believe that by studying the Lp(a) lipoprotein in Caucasians and African~     Americans, the investigators can assess for genetic variation factors related to~     cardiovascular (heart) disease. The investigators will be looking at 100 African-American~     families and 100 Caucasian families to confirm whether a higher Lp(a) level is an indicator~     of a higher risk for heart disease.~   "
206851|NCT00853749|"~     The primary purpose of this study is to evaluate the immune response to 13-valent~     pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a~     complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine~     (PSV). This study is also intended to evaluate the safety of the 13vPnC.~   "
207208|NCT00848965|"~     This is a single-centre, randomised, double-blind, four-period, incomplete block, crossover~     study, with 8 days repeat dosing of intranasal Fluticasone Propionate (25, 50, 100, 200ug)~     and/or placebo in the Vienna Challenge Chamber in subjects with allergic rhinitis.~   "
206853|NCT00853723|"~     This is a three month comparison trial of standard dose parathyroid hormone (PTH) (1-34) and~     two different doses of Parathyroid Hormone-related Protein (PTHrP) (1-36). The investigators~     want to to demonstrate that daily subcutaneous injection of PTHrP (1-36) in postmenopausal~     women with osteoporosis stimulates bone formation to the same or greater degree than PTH~     (1-34) but with less bone resorption.~   "
206854|NCT00853710|"~     The aim of the study is to compare the diagnostic performances of a simple and rapid PSA~     assay on whole blood to the standard plasma PSA assay.~   "
206855|NCT00853697|"~     Usually, the male hormone testosterone makes prostate cancer cells grow. Lowering~     testosterone usually stops the growth of prostate cancer. However, after a period of time~     without testosterone, prostate cancer cells learn to grow again.~      You are able to join this trial because your prostate cancer is growing even though you have~     very low levels of testosterone. Studies have shown that high doses of testosterone, in this~     situation, can cause prostate cancer cells to stop growing.~      The investigators did a study several years ago in which the investigators gave high doses of~     testosterone to patients such as yourself. The investigators showed that giving testosterone~     in this situation was safe. The investigators also showed that the investigators could, in~     some cases, make the PSA go down using high-dose testosterone.~      The investigators believe that they can improve this type of treatment by combining~     testosterone with another drug called dutasteride. Dutasteride is another type of hormone. It~     should make testosterone levels rise. The investigators believe that combination of~     dutasteride and testosterone will be more a more powerful regimen against your cancer than~     testosterone alone.~   "
206856|NCT00853684|"~     It is hypothesized that other anti-angiogenic agents such as endostar, may augment the effect~     of chemotherapy regimens in CRC. Endostar, a recombinant human endostatin which expressed and~     purified in E. coli, was approved by the SFDA for the treatment of non-small-cell lung cancer~     in 2005. Ling et al. found that endostar suppressed the VEGF-stimulated proliferation,~     migration, and tube formation of human umbilical vein endothelial cells (HUVECs) in vitro,~     and the antiangiogenic effects of endostar were correlated with the VEGF-triggered signaling.~     (Ling et al, 2007) A Chinese phase III clinical trial in advanced non-small-cell lung cancer,~     endostar--a new angiogenesis inhibitor prolonged the overall survival, time to progression~     and improved response rate. (Wang et al, 2005) Based on these results, the investigators~     design this phase II clinical trial of oxaliplatin, capecitabine and endostar as first line~     treatment, to evaluate whether endostar can bring survival benefits to patients with advanced~     colorectal cancer.~   "
206857|NCT00853671|"~     The investigators propose a novel technique using dual source multidetector computed~     tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is~     obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be~     devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and~     coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary~     plaque as well as assess the functional significance of a stenosis.~   "
206858|NCT00853658|"~     The study will evaluate the efficacy and safety of both aliskiren monotherapy and~     aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity~     and mortality in patients with chronic heart failure (NYHA Class II - IV.~   "
206859|NCT00853645|"~     Primary objective is to evaluate the safety and performance of the implanted S-ICD system. A~     maximum of 10 subjects were to be enrolled and followed for one month to collect data on the~     safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient~     comfort will be assessed as will cosmetic outcome.~   "
206860|NCT00853632|"~     The purpose of the study is to demonstrate the long term safety and effectiveness of the~     Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve~     replacement with or without concomitant procedures requiring cardiopulmonary bypass.~   "
206861|NCT00853619|"~     The goal of the Clinical Decision Support (CDS) Consortium research study is to assess,~     define, demonstrate, and evaluate best practices for knowledge management (KM) and CDS in~     healthcare information technology across multiple ambulatory care settings and electronic~     health records (EHR) technology platforms.~      There are seven specific research objectives focusing on two practical areas of~     implementation for clinical decision support services: a) healthcare maintenance and~     preventive care screening, and b) two chronic disease conditions: Coronary Artery Disease~     (CAD), and Adult-onset Diabetes Mellitus (AODM). The research objectives are: 1) Knowledge~     management lifecycle, 2) Knowledge specification, 3) Knowledge portal and repository, 4) CDS~     knowledge content and public web services, 5) CDS Dashboard, 6)Evaluation, and 7)~     Dissemination.~   "
206862|NCT00853606|"~     This open-label study is being conducted to evaluate the long-term safety, tolerability, and~     efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400~     subjects will be enrolled and treated with avanafil for up to 52 weeks.~   "
206863|NCT00853593|"~     This study is designed to show that a new lead, which paces the left bottom chamber (left~     ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart~     has been shown to potentially improve heart failure symptoms. The shape and size of this new~     lead may make it a good choice for patients or physicians.~   "
206864|NCT00853580|"~     The specific aim of this study is to determine whether Lovastatin ™ significantly improves~     visual spatial learning and/or sustained attention in children with NF1.~      Secondary Aims:~      To evaluate the effect of Lovastatin ™ on measures of executive function, behavior and~     quality of life in children with NF1 and cognitive deficits.~      To further evaluate the toxicity and tolerability of Lovastatin ™ in children with NF1 and~     cognitive deficits.~      Hypotheses~      It is hypothesized that Lovastatin ™ will improve the visual spatial memory and/or attention~     deficits in children with NF1. This is based on studies demonstrating that Lovastatin ™ has~     significantly improved impairments in visual spatial memory and attention in the NF1 murine~     model.~      It is further expected that Lovastatin ™ will be safe and well tolerated over a 16-week~     period.~   "
206865|NCT00853567|"~     Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex~     25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness~     between 50 mg versus placebo, and between 25mg and placebo will be analyzed.~   "
213181|NCT00769665|"~     To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a~     currently marketed contact lens rewetting drop will be included as a control.~   "
206867|NCT00853541|"~     Heart failure (HF) is a major public health problem, which affects about 5 million~     Americans.HF is when the heart muscle does not pump as much blood as the body needs. As a~     result of this,the body has difficulties in keeping an optimal fluid status. The fluid status~     of the body is regulated by both the heart and the kidneys. Due to the strong interaction~     between the heart and the kidneys, heart failure can result in a slight decreased kidney~     function as well.~      It is known that people who primarily suffer from chronic kidney disease (CKD) have a higher~     risk of developing arterial calcifications. Calcification of the arteries is caused by~     deposits of calcium within the walls of the blood vessels. Calcifications of the arteries may~     result in a loss of elasticity of the blood vessels. Recent research studies have shown that~     people with CKD have stiffer blood vessels which in these people, is associated with a higher~     chance of developing cardiovascular diseases.~      However, it is not known whether a decrease in kidney function in people with HF results in~     arterial calcification as well. In addition, it is not known whether this is also associated~     with a higher risk of developing cardiovascular diseases (diseases of the heart and blood~     vessels.) We are asking you to take part in this study because you have HF combined with some~     decrease in your kidney function.~      The purpose of this study is to see whether people with HF and a decrease in kidney function~     do have a higher chance of developing arterial calcifications. We will do this by comparing~     the results of the following; 1) several blood tests, 2) pictures taken of your heart by~     echocardiogram and computed tomography (CT) scan, and 3) measurements of the elasticity of~     your arteries. All of these tests are routinely used in clinical care. However, there have~     not been any research studies that have compared these results to see how they relate to~     arterial calcification in people with HF who have a decrease in kidney function.~      We also want to see whether people with HF and a decreased kidney function are at a higher~     risk of developing cardiovascular diseases. This study is being performed at Massachusetts~     General Hospital (MGH), in Boston Massachusetts. We expect to enroll a total of 150 subjects~     at MGH.~   "
206868|NCT00853528|"~     RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less~     damage to normal tissue. It may also help patients with spinal metastases live more~     comfortably.~      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic~     radiosurgery in treating patients with spinal metastases.~   "
206869|NCT00853515|"~     Vigorous fluid resuscitation is currently believed to play a key role in reducing~     complications associated with acute pancreatitis. However, aggressive fluid replacement can~     be associated with complications such as pulmonary fluid sequestration. The purpose of this~     study is to evaluate alternative approaches to early fluid resuscitation for patients with~     acute pancreatitis.~   "
206870|NCT00853502|"~     Decreased bone strength is a common and serious medical problem present in many people with~     anorexia nervosa. Men with anorexia nervosa have lower levels of gonadal steroids such as~     testosterone. Low testosterone levels have been shown to result in low bone density.~      We are investigating whether bone mineral density and bone microarchitecture are abnormal in~     males with anorexia nervosa and whether supplementation with testosterone would improve both~     bone mineral density and bone microarchitecture.~   "
206871|NCT00853489|"~     The purpose of our study is to evaluate the use of recombinant human bone morphogenetic~     protein 2 (RhBMP-2) as compared to standard ICBG in the treatment of severe open tibia~     fractures with a critical size bone defect (at least one centimeter in length compromising at~     least 50% of the circumference of the bone).~   "
206872|NCT00853476|"~     This study aims to compare skin reactivity results between morphine and histamine as a~     positive control agents in intradermal skin test.~   "
206873|NCT00853463|"~     Brigham and Women's Hospital will coordinate a Quality Improvement Initiative at other~     hospitals that focuses on whether physician notification prior to discharge of high risk VTE~     patients will reduce the incidence of VTE after hospital discharge.~   "
206874|NCT00853450|"~     The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on~     bleeding time when taken together with low-dose ASA.~   "
206875|NCT00853437|"~     The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals~     remains elusive to the clinician caring for critically ill pediatric patients even though a~     large proportion of these children are known to have hemodynamic compromise as a result of~     their illness. Current techniques used in adults to measure CO are not suitable for routine~     use with pediatric patients. A new ultrasound dilution approach provides an opportunity to~     measure cardiac output and blood volumes in pediatric patients. The main aim of this study is~     to compare CO measured by the new method with the clinician's estimate and implied CO from~     the measurement of the arteriovenous oxygen content difference.~   "
206876|NCT00853424|"~     Diabetic eye disease remains a major cause of visual loss for individuals with type 1~     diabetes, despite currently available treatments. Preliminary studies indicate that islet~     cell transplantation, a new treatment for type 1 diabetes, may be beneficial for some people.~     This study is designed to test the hypothesis that islet cell transplantation is more~     effective than current medical therapy in preventing the progression of diabetic eye disease.~   "
206877|NCT00853411|"~     Asthma is a clinical syndrome that is well recognized by health care practitioners, yet~     asthma pathogenesis still remains poorly understood. Asthma affects approximately 20 million~     Americans, who suffer around 5,000 deaths annually. More than 70% of people with asthma also~     suffer from allergies. Although many advances in understanding the pathophysiology of asthma~     have been made in the past few decades, more studies are necessary to achieve a more thorough~     understanding of asthma at the cellular and molecular level.~      The majority of murine models suggest asthma and allergic responses involve activation of~     Th2 cytokine pathways, including IL-4 and -13. Similarly in humans, several lines of evidence~     support a large role for Th2 adaptive immunity. These include the large majority of asthmatic~     patients with atopy; the measurement of increased amounts of Th2 cytokines, including IL-4~     and IL-13 in the airways and sputum of mild asthma; and most recently, the observed efficacy~     of anti-IgE therapy in allergic asthma. However, other data, including the large numbers of~     subjects with atopy and no asthma, suggest Th2 adaptive responses are insufficient to explain~     many aspects of asthma. Whether and how innate and adaptive immune pathways interact in human~     asthma is not clear, with few studies beginning to address these interactions in vitro and in~     vivo.~      For this reason, the investigators of this study would like to prospectively enroll patients~     with known asthma and follow them through an asthma exacerbation, while treating them with a~     standardized protocol. Over six week's duration, the investigators would like to study~     patients by collecting physiologic data such as spirometry, and biologic material in the form~     of sputum, nasal scraping, venous blood, exhaled breath and sputum. It is our aim to fully~     characterize the impact of the prostaglandin/cycloygenase/eicosanoid pathway as it relates to~     asthma exacerbation and recovery.~      Completion of this study in human asthma may provide new mechanistic insights into how~     relationships between innate and adaptive immune responses influence the course of an asthma~     exacerbation. The information obtained from this research and the corresponding studies may~     lead to innovative medical therapies and insight into the role of the epithelium and its~     interactions with both innate and adaptive immunity.~   "
206907|NCT00853008|"~     Current therapeutic protocols for adult ALL consider MRD together with the baseline risk~     factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for~     treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult~     patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study~     ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated~     therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and~     MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in~     HR Ph- adult ALL patients.~   "
214288|NCT00754884|"~     The purpose of this study is to determine whether nasal administration of salmon calcitonin~     is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.~   "
206878|NCT00853398|"~     Overall study design:~      A prospective, randomized, multi-center clinical studies comparing the minimal invasive and~     the standard surgical total knee replacement technique (control) using the Genesis II total~     knee system. The study will collect efficacy, safety and socio-economical data over 2 years.~     An additional 5 years follow-up interval is optional. The objectives (short-term follow-up)~     of the study are to:~        1. Assess whether the improvement in Pain and Range of motion per Knee Society scoring~          system and VAS score.~        2. Assess whether there are any differences between the surgical techniques as regards~          complication rate.~        3. Assess whether the hospital stay and the rehabilitation time (Straight leg raise,~          Active/passive ROM) of the patients differs between the two techniques.~        4. Assess the x-ray mechanical alignment between the two techniques.~      Attempts will be made to assess whether the collected peri-operative data (including incision~     length, blood loss, wound appearance, hospital readmissions and operative time) differs~     between the two surgical techniques.~      The primary objectives (mid-term follow-up) of the study are to:~        1. Improvement in Pain and Function per Knee Society Scoring system~        2. Number and Extent of Radiographic Lucencies >2mm~        3. Revision and knee-related adverse events~        4. Improvement in Quality-of-life via the VAS score~      5 investigational sites will participate and enroll a total of approximately 250 patients~     over a 12 months period. Thus, each site will enroll 50 patients.~   "
206879|NCT00853385|"~     This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background~     methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence~     of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background~     methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended~     to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function~     that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also~     included.~   "
206880|NCT00853372|"~     This phase 2 study is an open-label, multi-center study to determine the safety and~     tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with~     metastatic renal cell carcinoma.~   "
206881|NCT00853346|"~     The purpose of the study is to examine the effects of a form of talk therapy called cognitive~     behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's~     disease (PD).~   "
206882|NCT00853333|"~     The investigators propose to evaluate the potential effect of sedation on pain perception in~     two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's~     brain activation using fMRI(objective).~   "
206883|NCT00853320|"~     The objective of this open-label, randomized, two-period crossover study was to compare the~     oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 15 mg to an~     equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 15 mg, Roxane~     Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.~   "
206884|NCT00853307|"~     The purpose of this study is to evaluate the anti-tumour activity of alisertib (MLN8237) in~     the treatment of participants with platinum-refractory or platinum-resistant epithelial~     ovarian, fallopian tube, or primary peritoneal carcinomas.~   "
206885|NCT00853294|"~     The objective of this open-label, randomized, two-period, crossover study was to evaluate the~     oral bioavailability of the Mallinckrodt extended release test capsule formulation of~     chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a~     commercially available extended release oral suspension of chlorpheniramine~     polistirex/hydrocodone polistirex (Tussionex® Pennkinetic® Extended Release Oral Suspension,~     Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fasting conditions.~   "
206886|NCT00853281|"~     In Central Vietnam, forest malaria remains difficult to control due to the complex~     interactions between human, vector and environmental factors. Untreated bednets had a~     significantly protecting effect for villagers, except for those regularly sleeping in the~     forest, who suffer a significantly higher number of clinical attacks. Thus, there is need to~     target this high-risk group with new intervention based on long-lasting insecticidal~     materials. Hammocks are extensively used by people working in the forest, therefore~     long-lasting insecticidal hammocks (LLIH) could achieve a good individual protection.~      The Investigators proposed to evaluate their effectiveness in a community-based trial,~     comparing them to the standard vector control methods (insecticide-treated nets).~   "
206887|NCT00853268|"~     The objective of this open-label, randomized, two-period, crossover study was to evaluate the~     oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of~     oxycodone 40 mg compared to an equivalent oral dose of a commercially available~     controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group~     of healthy subjects under fed conditions.~   "
206888|NCT00853255|"~     Over the past decade, avian influenza (AI) has become a major health concern. The development~     of safe and effective vaccines against avian strains that infect people is important. The~     purpose of this study is to determine the safety of and immune response of an investigational~     AI vaccine in healthy adults against the H7N3 strain of avian influenza.~   "
206889|NCT00853242|"~     The purpose of this clinical study is to compare the effects of Genz-644470 with the effects~     of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in~     hyperphosphatemic chronic kidney disease participants on hemodialysis.~   "
206890|NCT00853229|"~     The purpose of this study is to determine whether pregabalin is effective in the treatment of~     vulvodynia.~   "
206891|NCT00853216|"~     The objective of this open-label, randomized, two-period crossover study was to compare the~     oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an~     equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane~     Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.~   "
206908|NCT00852995|"~     This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This~     research is being done to determine the effectiveness of two dosing frequencies and two~     different concentrations of HP802-247, together with standard care, compared to placebo, plus~     standard care.~   "
206909|NCT00852982|"~     A sedentary lifestyle is known to be a risk factor to developing type 2 diabetes. The aim of~     this study was to determine the effects of adding regular Nordic walking to daily physical~     activity. Effects on quality of life, cardiovascular risk factors and functions in muscle~     cells will be determined.~   "
206892|NCT00853203|"~     This is a Two-part Pilot Study: Part 1 is descriptive and Part 2 is a pilot randomized trial.~      Part 1 will be a formative study in which individual interviews are conducted with 20~     patients previously diagnosed with colorectal cancer. During open-ended interviews,~     researchers will collect data on QOL issues colorectal cancer patients face and will elicit~     feedback regarding development of and participation in a pilot expressive disclosure~     intervention. Patients also will pilot test an assessment procedures including completing the~     written questionnaires and wearing the Electronically Activated Recorder (EAR).~      Part 2 will include a small randomized pilot test in which 44 patients (two cohorts of 22~     patients) will be randomly assigned to the Expressive Disclosure Group Program or a Standard~     Care Control Group.~      Aims of the study include:~        -  To conduct a descriptive study of colorectal cancer patients, through qualitative~          interviews and standardized questionnaires, in an effort to assess their QOL, specific~          health and emotional problems, issues related to social functioning, and preferences~          regarding intervention format and logistics.~        -  To use the information from the descriptive study to develop an Expressive Disclosure~          Group Program for colorectal cancer patients.~        -  To pilot test a novel technology called the Electronically Activated Recorder (EAR) for~          assessing cognitive processing and social support in colorectal cancer patients and~          compare these data to those obtained with traditional self-report measures.~        -  To pilot test the Expressive Disclosure Group Program and conduct process evaluation~          including rates of recruitment and retention, attendance, satisfaction, barriers to~          participation, and feasibility of randomization.~        -  To explore the effects of the Expressive Disclosure Group Program on outcome variables~          of QOL and psychological functioning and mediating variables of cognitive processing,~          coping skills, and social support.~   "
206893|NCT00853190|"~     The objective of this open-label, randomized, two-period, crossover study was to evaluate the~     oral bioavailability of the Mallinckrodt extended release test capsule formulation of~     chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a~     commercially available extended release oral suspension of chlorpheniramine~     polistirex/hydrocodone polistirex (Tussionex® Pennkinetic® Extended Release Oral Suspension,~     Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fed conditions.~   "
206894|NCT00853177|"~     The purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness~     of self-controlled inhalation analgesia by nitrous oxide (N2O of 50% and 50% O2) by the~     patient compared to a local anesthesia combined with a tablet of 0.5 mg of Alprazolam.~   "
206895|NCT00853164|"~     60 eligible subjects will be randomized into one of three study arms 1) aerobic exercise, 2)~     resistance exercise, or 3) usual care. Baseline measurements will be done on all study~     subjects, these measurements include: height, weight, dual energy x-ray absorptiometry (DXA)~     for bone mineral density and lean body mass measurements, blood will be taken to measure~     serum free testosterone, prostate-specific antigen (PSA), glucose, and insulin levels.~     Fitness will also be evaluated using a graded exercise test. Questionnaires on health and~     personal history will also be completed. Men randomized to the aerobic exercise treatment arm~     will participate in a walking program three times a week for eight weeks. The participants~     will start at 15 minutes per session and increase to a goal of 60 minutes per session. Men~     randomized to the resistance training treatment arm will participate in an eight-week program~     of eight strength training exercises three times per week. Men in the usual care arm will~     receive written materials from the American Cancer Society about coping with cancer, which~     includes information about participation in physical activity. At the end of the eight week~     intervention participants in all three study arms will complete the same questionnaires and~     measurements they completed at baseline.~   "
206896|NCT00853151|"~     Test the safety, tolerability and improvement of blood sugar control with combination therapy~     in individuals with Type 2 Diabetes.~   "
206897|NCT00853138|"~     The purpose of this study is to develop and evaluate the feasibility and effectiveness of a~     web-based (i.e., internet) treatment approach for providing psychological treatment to reduce~     pain and improve functioning in children and adolescents with chronic pain.~   "
206898|NCT00853125|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor~     lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving~     sunitinib together with irradiated donor lymphocytes may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving sunitinib together with irradiated~     donor lymphocytes works in treating patients with metastatic kidney cancer.~   "
206899|NCT00853112|"~     Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)~   "
206900|NCT00853099|"~     The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese~     subjects with moderately to severely active ulcerative colitis (UC).~   "
206901|NCT00853086|"~     This study is conducted in Europe. The purpose of this retrospective study is to collect~     additional safety information of patients with haemophilia and inhibitors who are treated~     with rFVIIa.~   "
206902|NCT00853073|"~     The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma~     surgery improves the success of needle bleb revisions.~   "
206903|NCT00853060|"~     During weaning from mechanical ventilation process, the energy expenditure in T tube is~     greater than pressure support ventilation.~   "
206904|NCT00853047|"~     The purpose of this study is to evaluate the safety and tolerability of LX1606 versus a~     placebo control in subjects with symptomatic carcinoid syndrome not managed by stable-dose~     long-acting octreotide therapy. Following determination of the maximally tolerated or~     effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.~   "
206905|NCT00853034|"~     The purpose of the study is to evaluate the effects of arabinoxylan-oligosaccharides (AXOS)~     on the colonic metabolism and microbial composition, and to compare these effects with the~     reference prebiotic fructo-oligosaccharide enriched inulin.~   "
206906|NCT00853021|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Biological therapies, such as~     aldesleukin, may stimulate the immune system in different ways and stop tumor cells from~     growing. Giving bevacizumab together with aldesleukin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with~     aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.~   "
206910|NCT00852969|"~     The purpose of this study is to obtain information on whether raising levels of~     HDL-cholesterol (the good cholesterol) can improve how blood vessels work in kidney~     disease. This may help us understand the causes leading to high rates of heart disease in~     kidney disease and also ways to reduce this risk.~   "
214834|NCT00747630|"~     Evaluating the efficacy of a video about FAS to determine whether it has an impact on~     knowledge about FAS and their likelihood to participate in risk taking behavior.~   "
206911|NCT00852956|"~     This will be a phase I, randomized, two-arm, double-blind, placebo-controlled, sequential~     study in up to 50 healthy female subjects. The study will be comprised of three treatment~     periods for a total of 4 weeks treatment duration:~      Period I 1 week (Days 1-7) administration of betahistine daily (three times per day; 144~     mg/day total) or matching placebo.~      Period II 1 week (Days 8-14) titration of olanzapine once daily (2.5 to 10 mg) and~     continuation of betahistine or matching placebo administration (daily; three times per day)~     Period III 2 weeks (Days 15-28) of continued co-administration of betahistine/matching~     placebo, three times per day, and olanzapine once daily (7.5 to 10 mg/day)~   "
206912|NCT00852943|"~     Background:~        -  Mast cells are responsible for most symptoms of allergic reactions. In some allergic~          diseases, it is unusually easy to cause mast cells to release their contents and cause~          allergic reactions. In other cases, mast cells grow abnormally and, in rare cases, can~          result in tumors. Mast cells also control other parts of the immune system.~        -  Understanding why mast cells behave abnormally in allergic diseases is important to~          finding better ways for diagnosing and treating these potentially life-threatening~          disorders.~      Objectives:~        -  To screen mast cells at the genetic and functional levels to characterize abnormalities,~          identify mutations, detect carrier states, and/or develop therapies for such disorders.~        -  To create a library of information about inherited diseases of mast cell homeostasis and~          activation, including piebaldism (problems with skin and hair pigmentation), anaphylaxis~          (severe allergic reaction), allergies, asthma, atopic dermatitis (eczema), allergic~          rhinitis ( hay fever ), food allergies, urticaria/angioedema (hives/swelling),~          immunodeficiency diseases, and autoimmune diseases.~      Eligibility:~        -  Patients between the ages of 1 and 80 years who have been referred by a physician and~          are known to have or be suspected of having an inherited disorder of mast cells, in~          particular patients (and their relatives) with piebaldism, allergies, or anaphylaxis~          that is not caused by allergies.~      Design:~        -  Study population will consist of up to 1000 participants in a 5-year period. One third~          of the study population will consist of patients; the other two thirds will consist of~          biological relatives.~        -  Evaluation is limited to testing on blood specimens; no treatment will be provided.~        -  Clinical and research laboratory evaluations of patients will include the following:~        -  Clinical evaluation and previous laboratory tests as documented in outside medical~          records by health care providers. A standard questionnaire will also be administered at~          the time of subject enrollment.~        -  Blood collection for clinical laboratory testing, tailored to each subject s clinical~          evaluation where appropriate (5 ml).~        -  Blood collection for research laboratory testing, tailored to each subject s clinical~          evaluation including genetic screening and assessment of mast cell growth and~          functioning and storage of additional frozen blood specimens for future studies (up to~          an additional 30 ml).~        -  Evaluations of blood relatives will include the following:~        -  Clinical evaluation as documented from outside medical records by health care providers~          and administration of a standard questionnaire.~        -  Blood collection where indicated for diagnostic or research purposes.~        -  After 12 consecutive months on the study, results from initial evaluation will be~          reviewed. Subjects with findings deemed to be of continued interest will be contacted~          and invited to remain as active participants to this protocol for another year, provided~          that they renew their consent to participate.~   "
206913|NCT00852930|"~     Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the~     arm) is the current standard of treatment for breast cancer related lymphedema (arm~     swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional~     and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many~     lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a~     stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality~     to Manual Lymphatic Drainage. The objective of this proposed pilot study is to examine the~     impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and~     complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer~     survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT~     has possible value in the treatment of lymphedema and warrants subsequent evaluation in a~     larger study.~   "
206914|NCT00852917|"~     The objective of this study is to compare the analgesic efficacy and safety of Tramadol Once~     a Day 100, 200, 300 mg and Placebo~   "
206915|NCT00852904|"~     Patterns of illness among children in the United States and other industrially developed~     nations have changed substantially during the past 100 years. Before and during the first~     half of the previous century, infectious diseases were the primary threat to children s~     health. In contrast, the major illnesses and disorders that impair health, growth, and~     development today are chronic conditions stemming from the complex interaction of~     environmental exposures and inherent genetic factors. The Children s Health Act of 2000~     directed the National Institute of Child Health and Development to conduct a national~     longitudinal study of environmental influences on children s health in the United States. The~     act specified that the study extend from the prenatal period to adulthood and investigate the~     short-term and long-term influences of physical, chemical, biological, and psychosocial~     environmental exposures on children s health and development, including behavioral,~     emotional, and educational outcomes in addition to physical health. The National Children s~     Study (NCS) is an observational longitudinal study that will enroll and follow a nationally~     representative sample of approximately 100,000 U.S.-born children from before birth through~     their 21st birthday. The study will screen all households within selected areas of 105~     locations (primarily counties).~      The major types of analysis of NCS data will include longitudinal exposure-outcome analysis,~     identification of causal pathways, analysis of neighborhood effects, evaluation of temporal~     effects within longitudinal data analysis of data from case-control data, and analysis of~     genomic data.~      Women in their first trimester of pregnancy will be invited to participate in the~     pre-pregnancy portion of the NCS. Women who are not pregnant but have a high probability of~     becoming pregnant will be asked to participate in the early pregnancy portion of the NCS. All~     other eligible women will be asked if the study can contact them periodically to assess their~     pregnancy status. They also will be asked to contact the NCS should they become pregnant.~     Women identified as pregnant within 4 years after initial screening will be invited to enroll~     in the NCS.~      The following information will be gathered:~      Mother s data and information~        -  Questionnaire data interviewed and self-administered (e.g., demographics; current~          pregnancy history; reproductive history; medical conditions; health behaviors; doctor~          visits; medicines and supplements; housing characteristics; pesticides, product use;~          occupation, hobbies; depression, stress; social support; diet; time and activity)~        -  Physical measures and clinical data (e.g., blood pressure, sonograms, height, weight,~          body measurements)~        -  Biologic specimens (e.g., blood, urine, hair, saliva)~        -  Environmental samples during home visits (e.g., dust, air, water)~        -  Medical record abstraction~      Infant s data and information at birth~        -  Cord blood and tissue samples of the placenta and umbilical cord~        -  Standardized neurobehavioral exam~        -  Physical measures and clinical data (e.g., length; weight; circumferences of head, arm,~          abdomen, thigh)~        -  Meconium samples~        -  Medical diagnoses and treatment by report~        -  Selected Medical record abstraction~   "
206916|NCT00852891|"~     The objective of this study was to analyze changes in cardiac function using Doppler~     echocardiogram in critical patients during weaning from mechanical ventilation using two~     different weaning methods (pressure support and T-tube) and to compare a subgroup of~     patients: success vs. failure in weaning and patients with vs. without heart disease.~   "
206917|NCT00852878|"~     The purpose of this study is to determine if two treatments, a biofeedback and behavioral~     protocol, for recurrent abdominal pain are equally effective.~   "
206918|NCT00852865|"~     We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a~     hyperalgesia on response to thermal stimulation. A comparaison of results before and after~     three weeks of treatment will be made.~   "
206919|NCT00852852|"~     This research study will test a new online computer program for patients, the Electronic~     Self-Report Assessment-Cancer (ESRA-C 2). The program allows patients to report symptoms and~     quality of life issues and learn information about how to deal with these experiences. The~     computer program is being tested to see if it can improve communications between patients and~     their care team and if it can improve patients' experiences during and after treatment.~   "
206920|NCT00852839|"~     This clinical study is to determine whether daily administration of a formulation of 552-02~     improves the dry mouth condition in subjects with primary Sjögren's syndrome.~   "
206921|NCT00852826|"~     This study was intended to assess the value of a hemostatic and sealing agent, a collagen~     sponge coated with human coagulation factors (fibrinogen and thrombin) (TachoSil®), for~     decreasing occurrence of seroma after axillary lymphadenectomy.~   "
206922|NCT00852813|"~     The purpose of the study is to evaluate the tolerance of a higher dose of~     arabinoxylan-oligosaccharides (AXOS) and their prebiotic activity in healthy subjects.~   "
206923|NCT00852800|"~     Spontaneous bacterial peritonitis (SBP) is a common and severe complication of cirrhosis. The~     most serious complication of SBP is the hepatorenal syndrome (HRS), which occurs in up to 30~     percent of patients, with high mortality. Intravenous albumin (1.5 g/kg at diagnosis and 1~     g/kg 48 hours later - standard regimen) helps to prevent HRS and improves survival. No~     information exists on the efficacy of lower doses of albumin. This study was designed to~     allow direct comparison among different doses of intravenous albumin in patients with SBP -~     standard (SR) vs dose reduced regimen (DRR) - in order to prevent renal failure and~     mortality.~   "
206924|NCT00852787|"~     The purpose of this study is to examine the effects of the digibind drug on hemodialysis~     patients with high blood pressure. Digibind is used to treat toxicity from digoxin and~     digoxin-like molecules which may contribute to high blood pressure.~   "
206925|NCT00852774|"~     The purpose of this study is to assess changes of intra-ocular pressure (IOP) and examine~     preoperative facts affecting IOP in endometrial cancer patients undergoing robotic~     hysterectomy compared to laparotomy.~   "
206926|NCT00852761|"~     The purpose of the study is to determine the efficacy and safety of two different forms of a~     topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.~   "
224271|NCT00622934|"~     The purpose of this study is to determine whether Erythropoietin decrease stress responses~     and inflammation in trauma patient.~   "
206927|NCT00852748|"~     Clinical and neuroradiologic study concerning patients suffering of cough, exertional and~     sexual headaches disorders (pathophysiology) concerning a venous hypothesis implication,~     redescribe clinical headaches specifications, confirmed if cough headaches is a clinical~     entity and if it has neuroradiologic differences with effort or sexual activity headaches.~   "
206928|NCT00852735|"~     The purpose of this study is to assess the effect of optimized oil (enriched with~     micronutriments) on the prevention on cardiovascular diseases.~      Randomised crossover dietary intervention study:~      The main objective of the clinical study is to investigate the effect of the consumption of~     an optimized rapeseed oil on the lipid metabolism of volunteers as compared with the~     consumption of a reference oil.~      Post prandial study:~      The second objective of the clinical study is to investigate the effect of the consumption of~     an optimized rapeseed oil on the biomarkers of oxidative stress during post prandial period~     as compared with the consumption of a reference oil.~   "
206929|NCT00852722|"~     The purpose of this study is to evaluate if following a specific low fat diet will improve~     the brain damage as seen by Magnetic Resonance Imaging (MRI) and to decrease the progression~     of multiple sclerosis (MS) as evidenced by clinical evaluation and symptoms.~   "
206930|NCT00852709|"~     This is a Phase I study designed to determine the MTD and assess the toxicity associated with~     clofarabine followed by fractionated cyclophosphamide in patients > 1 year of age or < 21~     years of age with relapsed or refractory acute leukemias. There will be 25 to 35 patients~     enrolled. Cohorts of 3 to 6 patients each will receive escalated doses of clofarabine~     followed by fractionated cyclophosphamide until the MTD is reached. There will be no~     intra-patient dose escalation. Single-agent cyclophosphamide will be administered by 2-hour~     IVI on Day 0 of cycle 1. On Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be~     administered by IVI 2 hours before each dose of cyclophosphamide (see the treatment schema~     below). A cycle is defined as 28 days.~   "
206931|NCT00852696|"~     The purpose of this study is to determine whether treatment with anti-muscarinic medications~     following sub-urethral sling procedures improves overall subjective and objective outcomes in~     women with mixed incontinence with primary stress symptoms.~   "
206932|NCT00852683|"~     Breast cancer is a devastating disease. Some women with breast cancer undergo surgery to~     remove the breast and lymph nodes in the axilla (armpit). Unfortunately, surgery of this type~     is associated with pain both in the days immediately following the operation and in the long~     term. Pain that continues for more than three months after surgery is known as chronic pain~     and affects as many as 1/5 to more than ½ of patients having this surgery. Often this pain is~     of a particular type known as neuropathic pain. There have been studies demonstrating that~     the intensity of pain after surgery may be related to the likelihood of developing chronic~     pain. It is important to develop methods to reduce acute pain after breast cancer surgery and~     to reduce chronic pain for breast cancer survivors.~      Pregabalin is a medication used in the treatment of chronic pain. It has been shown to be~     effective for neuropathic pain. There has also been one study demonstrating its effectiveness~     in reducing pain after dental extraction. We are interested in determining whether pregabalin~     taken for 14 days starting the day of surgery will reduce acute (short term) pain and chronic~     pain from this type of breast cancer surgery.~      In order to test ability of pregabalin for the reduction of chronic pain it may be necessary~     to follow a large number of patients for up to one year after surgery. This may require~     studying patients in more than one institution. Prior to starting such a large study we are~     proposing a pilot or preliminary study. This study will follow a smaller group of~     participants (68) for 6 months. From the pilot study we will determine the effect of~     pregabalin on acute pain and logistic and statistical information required for the full~     study. We will randomly assign participants to receive pregabalin or placebo (sugar pills)~     for twice daily for 14 days starting one hour before surgery. We will monitor the~     participants' pain at one hour after surgery, 24 hours after surgery, one week, two weeks,~     three months and six months after surgery. We will also monitor for a number of other~     parameters such as medication side effects and the need for other pain medications.~     Recruitment of study participants is expected to take 6-7 months.~   "
206933|NCT00852670|"~     This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with~     moderate to severe plaque psoriasis.~   "
206934|NCT00852657|"~     The purpose of this study is to compare treatment benefits from surgical treatment by tendon~     repair and from physiotherapy for small and medium-sized rotator cuff tears.~   "
206935|NCT00852644|"~     RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less~     damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic~     radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.~   "
206936|NCT00852631|"~     The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia~     patients with acute worsening symptoms. Consequently, to assess whether the study drug is~     safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42~     days.~   "
206937|NCT00852618|"~     The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has~     been shown in several trials to be highly effective. The main study will estimate the viral~     load decay rate in treatment-naive HIV-infected participants receiving RAL and~     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).~      This substudy of A5248 will similarly examine the characteristics of decrease in viral load~     but will focus on estimating the time at which first-phase viral decay starts, following~     initiation of the study drugs.~   "
206938|NCT00852605|"~     Acute lung injury (ALI) is an early complication after allogeneic transplantation causing~     significant mortality and morbidity. Little is known on early markers and treatment of this~     complication. Recent data (Hilbert et al.) suggested a beneficial effect of~     Non-Invasive-Ventilation in ALI-patients immunosuppressed because a many different reasons~     including stem-cell transplantation.~      The investigators study is designed to evaluate early markers of ALI after allogeneic~     transplantation. In case ALI is documented patients are randomized to either conventional~     therapy (oxygen-support) or conventional therapy plus intermittent Non-Invasive Ventilation.~     The hypothesis is that Non-Invasive Ventilation improves outcome of ALI after allogeneic~     transplantation.~   "
206939|NCT00852592|"~     The purpose of this study is to understand the efficacy of light therapy for bipolar~     depression.~   "
206950|NCT00852449|"~     Postoperative organ dysfunction severely affects the prognosis of surgical patients. Despite~     several trials evaluating restrictive or liberal fluid strategies, the ideal fluid~     replacement strategy remains controversial. Owing to the risk of altered tissue perfusion, a~     key trigger of organ dysfunction, the purpose of this study was to compare the influence of~     restrictive and liberal fluid regimens, using a goal-directed approach, on hypovolemia and~     postoperative organ dysfunction.~   "
206951|NCT00852436|"~     The purpose of this study is to determine whether pregabalin can decrease pain and improve~     quality of life in patients who have nerve pain on the mouth or the face~   "
207209|NCT00848952|"~     The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI,~     CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular~     carcinoma for patients with cirrhosis.~   "
206940|NCT00852579|"~     Asthma is a common disease in Westernised societies, affecting up to 10% of the population.~     Corticosteroids are the most effective treatment for asthma but the therapeutic response~     varies considerably between individuals. A major cause of corticosteroid insensitivity in~     asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with~     asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the~     investigators demonstrated for the first time that the efficacy of inhaled and oral~     corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in~     ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma~     morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated~     decline in lung function. Smoking cessation advice is often ineffective because many adult~     smokers with asthma do not believe that they are personally at risk from their smoking, take~     many years until stopping smoking and frequently restart smoking after quitting. Alternative~     or additional drugs to corticosteroids are needed for smokers with asthma who are unable to~     obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical~     trial the investigators will test the hypothesis that macrolides improve asthma control and~     reduce sputum neutrophil counts of smokers with chronic asthma.~   "
206941|NCT00852566|"~     A randomized multi-center study comparing the effect of dasatinib and imatinib on malignant~     stem cells in newly diagnosed chronic phase chronic myeloid leukemia (CML) patients. The~     research hypothesis is that treatment with dasatinib 100 mg daily (QD) results in greater and~     more rapid depletion of the Philadelphia (Ph) -positive stem cell pool within 6 months of~     therapy than imatinib 400 mg QD in newly diagnosed CML patients. The study duration is 18~     months and approximately 40 patients will be recruited to the study.~   "
206942|NCT00852553|"~     A collaborative research project with Dr. Kathleen Keef (Department of Physiology, University~     of Nevada School of Medicine, Reno, Nevada) studying the role of putative neurotransmitters~     in human intestine.~   "
206943|NCT00852540|"~     The purpose of this study is to provide further evidence of the clinical and bacteriological~     efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA.~     Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days~     or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up~     (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The~     primary population is the per-protocol MRSA population. It is anticipated that approximately~     500 subjects may be enrolled in order to obtain approximately 105 subjects who have a~     baseline MRSA infection.~   "
206944|NCT00852527|"~     The purpose of the proposed study is to determine the clinical validity and reliability of~     the VA's Traumatic Brain Injury (TBI) Clinical Reminder Screen and the Comprehensive TBI~     Evaluation used to screen for mild traumatic brain injury. Examining the reliability of the~     two screens will determine whether they are dependable. Verifying the clinical validity is~     important because valid screening and evaluation of mild TBI leads to accurate diagnosis and~     timely treatment. Accurate screening also improves clinical efficiency and ensures that~     resources are provided to those who need them most. The project findings are expected to~     advance the science of screening and diagnosis of a mild TBI event.~   "
206945|NCT00852514|"~     Peritoneal dialysis (PD) is a widely used modality of renal replacement therapy. Due to its~     continuous nature of therapy, better control of fluid status and preservation of residual~     renal function were presumed by most nephrologists. However, recent evidences showed that it~     might not be the case. The severity of fluid overloading and the need for anti-hypertensive~     agents to control blood pressure seems to be more severe for PD patients. Therefore, more~     aggressive strategy to control dry weight is mandatory in PD patients. However, over~     reduction of dry weight might affect residual renal function (RRF) and, probably, the~     survival of PD patients. A balance between reduction of dry weight and preservation of RRF is~     crucial for the care of PD patients. Currently, only clinical measures like cardiothoracic~     ratio on chest X-ray and absence of pedal edema were used to evaluate PD patient's dry~     weight. There is no objective method to determine dry weight accurately. In this prospective~     and randomized study, the investigators will use multi-frequency bio-impedance (MF-BIA) to~     detect intracellular and extracellular water (ECW) content of patients.~   "
206946|NCT00852501|"~     Characterization of receptors present in non-functioning pituitary macroadenomas by Reverse~     Transcriptase- Polymerase Chain Reaction (RT-PCR) would assist with targeted medical therapy~     based on the information obtained by immunohistochemistry and RT-PCR.~   "
206947|NCT00852488|"~     This study is designed to evaluate medium-term central venous catheter placement in infants~     undergoing complex cardiac surgery using a new technique. This technique involves placement~     of the catheter into the inferior vena cava through a subcutaneous tunnel and through a~     tunnel between pericardium and diaphragm.~   "
206948|NCT00852475|"~     The purpose of the study is to examine the effects of 2 commonly used diets, a Mediterranean~     monounsaturated fatty acid enriched (MUFA) or AHA polyunsaturated (PUFA) enriched diet~     combined with the VA Managing Overweight/Obesity for Veterans Everywhere (MOVE!) program so~     as to determine which one is superior in reducing cardiometabolic risk factors associated~     with Metabolic Syndrome. The risk factors considered include lipids and lipoproteins,~     inflammatory markers such as CRP and adiponectin, endothelium-dependent flow-mediated~     vasodilatation (FMD) and the postprandial lipid responses to a meal.~      Cardiometabolic risk factors will be determined by measuring several cardiovascular risk~     associated parameters including:~      Biochemical measurements of lipids and inflammatory markers, body composition and VO2max~     (Specific Objective 1, Descriptive).~      Postprandial response to a meal challenge and endothelial vasoreactivity (FMD) assessed by~     BART (Specific Objective 2, Physiological).~      Determination of the effects on postheparin lipases and transfer protein activity, visceral~     adipose tissue (VAT) and homeostasis model assessment-estimated insulin resistance (HOMA-IR)~     (Specific Objective 3, Mechanistic)~   "
206949|NCT00852462|"~     The purpose of this study is to develop and test the usability of a computerized symptom~     assessment and management intervention system in a laboratory setting (phase I) and its~     feasibility in a clinical setting in a group randomized trial (phase II).~   "
206964|NCT00852267|"~     The purpose of this study is to test whether replacing dietary carbohydrate with protein,~     using beef as the primarily source of protein, will improve risk factors for cardiovascular~     disease.~   "
206952|NCT00852423|"~     Malaria is the most important human parasitic disease and is responsible of high morbidity~     and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are~     almost always excluded from clinical trials; thus, the investigators lack sufficient~     information on the safety and efficacy of most antimalarials in pregnancy. The recommendation~     of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and~     3rd trimester is already implemented in several African countries, however documentation of~     their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to~     evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate,~     mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women~     with P. falciparum malaria; the results will help to recommend the optimal therapy for this~     high-risk group in Africa.~   "
206953|NCT00852410|"~     Obtaining adequate hemostasis is crucial during endoscopic sinus surgery. Submucosal~     injection of local anaesthetic containing adrenaline has frequently been used to improve~     surgical milieu. However, injection of adrenaline has potential side effects including~     tachycardia, hypertension as well as inducing arrhythmia. The aim of this randomized clinical~     trial is to assess the hemodynamic and hemostatic effects of two different concentrations of~     adrenaline in local anaesthetic used during endoscopic sinus surgery.~   "
206954|NCT00852397|"~     The purpose of this study is to assess the bleeding safety (the composite endpoint of major~     and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg~     BID) or placebo in combination with standard therapy (aspirin and /or additional antiplatelet~     therapy) over a 24 week treatment period in selected subjects with recent (≤7 days) acute~     coronary syndrome.~   "
206955|NCT00852384|"~     The purpose of this study is to compare the effects of noninvasive pressure support~     ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly~     obese patients on both oxygenation and functional residual capacity modifications.~   "
206956|NCT00852371|"~     This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy,~     safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary~     objective of the study is to compare the efficacy of different combination antimalarial~     regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP),~     dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment~     (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after~     42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic~     infections and the efficacy for prevention of new infections.~   "
206957|NCT00852358|"~     This is a 24-month study of the use of laronidase administered into the spinal fluid to treat~     cognitive decline in mucopolysaccharidosis I (MPS I). MPS I is a rare genetic condition due~     to deficiency of the enzyme alpha-l-iduronidase. Laronidase is the manufactured form of the~     enzyme alpha-l-iduronidase.~      MPS I is a heterogeneous disease with several clinical phenotypes ranging from the most~     severe, Hurler syndrome, to the attenuated forms, Hurler-Scheie and Scheie. Although patients~     with milder forms of MPS I may not have grossly observable problems with cognition, these~     patients do have learning difficulties that are apparent in school and with~     neuropsychological testing. The goal of this study is to evaluate whether intrathecal~     recombinant human alpha-l-iduronidase (rhIDU) injections can stabilize or improve cognitive~     decline in individuals with MPS I.~   "
206958|NCT00852345|"~     Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World~     Health Organization and the National Hansen's Disease Program consider clofazamine to be~     standard therapy for treatment of multibacillary leprosy. In recent years, the availability~     of the drug has become limited and is currently available only under a research protocol and~     is considered investigational. Use of Clofazamine in patients presenting with lepromatous~     leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other~     therapies. This drug will be used prospectively for patients who require treatment of leprosy~     as deemed appropriate by a Kaiser Permanente Southern California physician.~   "
206959|NCT00852332|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary~     supplements, such as phytochemicals, may stop or delay the development of breast cancer. It~     is not yet known whether giving docetaxel together with a phytochemical is more effective~     than giving docetaxel alone in treating patients with breast cancer.~      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with a~     phytochemical works compared with giving docetaxel alone as first- or second-line therapy in~     treating patients with breast cancer.~   "
206960|NCT00852319|"~     The IPC program will enroll women who deliver Very Low Birth Weight babies (stillborn or~     liveborn) at University of Mississippi Medical Center and women who have Very Low Birth~     Weight babies that receive treatment in the Neonatal Intensive Care Unit at University of~     Mississippi Medical Center and provide each woman with 24 months of funded comprehensive,~     integrated, primary health care services (including family planning, social services, general~     medical services,and basic dental care), and enhanced case management. The services will be~     community-based (via UMC Clinics, community health centers, and outreach programs) and will~     be provided by a multidisciplinary team of physicians, nurses, social workers, case managers,~     and Resource Mothers/Resource Workers. At the end of project follow-up, we will evaluate the~     success of the program in terms of improvement of general health status of enrolled women,~     and subsequent reproductive health outcomes (i.e., achieving reproductive intentions,~     intendedness and spacing of subsequent pregnancies, birth weight distribution of subsequent~     pregnancies) and cost of delivery services compared to reproductive health outcomes in the~     project's control population.~   "
206961|NCT00852306|"~     The purpose of this study is to determine the best way to freeze eggs in order to preserve~     the fertility potential of young women.~   "
206962|NCT00852293|"~     Chitinase and chitinase like proteins are members of the 18-glycosyl-hydrolase family.~     Several reports have linked the chitinase 3 like 1 protein with colitis, asthma and liver~     disease.~      This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical~     parameters such as disease severity, reaction to treatment, portal hypertension and~     prognosis.~   "
206963|NCT00852280|"~     The purpose of this study is to identify changes in color, thickness, and stiffness, of scars~     from skin grafting after burns when treated with a pulsed-dyed laser.~   "
206965|NCT00852254|"~     A novel method to measure cardiac index based on ultrasound indicator dilution technology~     (UIDT) has been developed by Transonic Systems Inc. (Ithaca, NY, USA). The method overcomes~     many of the limitations that have plagued the existing techniques used to measure cardiac~     index in critically ill children.~      In the proposed investigation, the investigators hope to validate a novel application of an~     existing technology in critically ill infants and children. The primary aim of this study is~     to determine the accuracy of cardiac index measured by UIDT when compared to the~     gold-standard Fick technique. The primary hypothesis is that the average of three consecutive~     measurements of cardiac index by UIDT will be accurate when compared to the Fick technique.~     Secondary aims will be to determine the precision of the measurement, the feasibility of the~     technique with regards to time required and any complications encountered. An exploratory~     secondary aim of this study is to determine whether central blood volume (CBV) derived from~     indicator transit time (ITT) correlates with central venous pressure (CVP) and~     echocardiography derived measures of preload.~   "
206966|NCT00852241|"~     The primary objective of this study is to determine the efficacy and longevity of the use of~     Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and~     to measure patient satisfaction with this treatment~   "
206967|NCT00852228|"~     The primary objective of the study is to increase by 15% the complete macroscopic resection~     rate of predominantly liver metastases from metastatic colorectal cancer through combining~     systemic cetuximab and hepatic artery infusion of three-drug chemotherapy (irinotecan,~     oxaliplatin and 5-fluorouracil).~   "
206968|NCT00852215|"~     We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large~     vessels compared with bare metal stent.~   "
206969|NCT00852202|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     cariprazine in the treatment of outpatients with bipolar depression.~   "
206970|NCT00852189|"~     This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses~     of EC0489 in patients with refractory or metastatic tumors who have exhausted standard~     therapeutic options.~   "
206971|NCT00852176|"~     The study will evaluate the long-term safety and efficacy of intravascular beta radiation~     therapy to treat coronary in-stent restenosis using the Beta-Cath(TM) 3.5F System; data will~     be collected retrospectively on patients treated with the Beta-Cath™ 3.5F System in routine~     clinical practice following FDA pre-market approval of the System. Outcomes will be reported~     up to 5 years following treatment.~   "
206972|NCT00852163|"~     The purpose of this study is to determine whether Clofarabine in combination with Busulfan is~     effective as a preparative transplant regimen for the treatment of leukemia and~     myelodysplastic syndromes~   "
206973|NCT00852150|"~     The modified Lanza scale (Lanza FL, 1984) has been widely utilized to grade the degree of~     gastritis and duodenitis. However, the inter-rater or intra-rater reproducibility of this~     scale has never been validated. As a quality improvement program, it is important to study~     the reproducibility of the scale between different operators and the operators himself.~      Method: During upper endoscopic examinations, one investigator performed the procedure and~     the second investigator look at the endoscopic image. The degree of gastritis and duodenitis~     is graded. The results of the grading are blinded to the other investigator.~      The endoscopic video is stored for reassessment to determine the intra-rater reliability. The~     patient identifier is stored in serial number. The investigator will not retrieve the report~     of the first assessment during the second assessment.~   "
206974|NCT00852137|"~     This Phase II study is designed to evaluate the pharmacokinetics of PEP005 (ingenol mebutate)~     Gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in~     patients with actinic keratoses~   "
206975|NCT00852124|"~     We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double~     blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA~     IND review of a pediatric asthma protocol.~      Adults with a doctor diagnosis of persistent asthma will take VSL#3 or placebo twice daily~     for 3 months. Data will be collected, including age, race, height, and weight, present~     medications, past medical history with emphasis on signs/symptoms of asthma.~      On visits to the clinic we will evaluate~        -  Changes in lung function~        -  Intestinal permeability~        -  Intestinal bacteria~        -  Levels of inflammation in the blood~        -  Women will have repeat urine pregnancy testing at each clinic visit~   "
206976|NCT00852111|"~     Background:~        -  Researchers have studied the causes of fatigue during treatments for various diseases,~          but these results have not been conclusive.~        -  More information on the physical changes that affect the body during treatment may help~          identify biological or chemical factors that contribute to patient fatigue, which may~          allow physicians to identify individuals who may be more at risk of feeling fatigue~          before, during, and after treatment for diseases such as cancer.~      Objectives:~        -  To identify factors contributing to fatigue in men who are undergoing radiation~          treatment for prostate cancer.~      Eligibility:~        -  Men 18 years of age and older who are scheduled to receive localized radiation treatment~          for prostate cancer.~      Design:~        -  Six outpatient visits to the NIH Clinical Center, approximately on the same day and same~          time of day:~        -  First visit before beginning radiation treatment.~        -  Once a week for the first 2 weeks of the treatment, once at the midpoint of treatment,~          once at the end of treatment.~        -  Final visit 4 weeks after completion of radiation treatment.~        -  Initial visit will involve a physical examination and questions about medical history.~        -  Evaluations during the treatment period:~        -  Blood draws to identify cells and chemicals associated with inflammation and fatigue.~        -  Questions about physical activity, fatigue, depression, and quality of life.~   "
207026|NCT00851461|"~     This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has~     benefit in SBMA~      Objective:~        1. To study effects of Goserelin to clinical course of patients with spinal and bulbar~          muscular atrophy in Thailand~        2. To demonstrate physiological and pathological changes in treated patients with~          Goserelin.~        3. To assess tolerability and adverse effect of Goserelin therapy~   "
207027|NCT00851448|"~     To test the compliance, tolerance, safety and to get preliminary insights into the efficacy~     of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and~     antioxidants) designed to prevent or delay cachexia and anorexia in lung cancer patients.~   "
206977|NCT00852098|"~     Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the~     most common surgical treatment for gastro-esophageal reflux. Although this procedure is~     effective, some patients still develop complications. Indeed, dividing the short gastric~     vessels is claimed by many authors to confer benefit to patients even it could not be proved~     in other studies. In an attempt to evaluate the role of dividing the short gastric vessels~     and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the~     investigators initiated a randomized clinical trial to clarify this important fact. Patients~     were recruited for this trial and short-term results had been already published in a national~     journal. The investigators are now registering this study which particularly focuses on the~     endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical~     treatment.~   "
206978|NCT00852085|"~     To examine the effectiveness of four motivational counseling groups and a directed~     observational experience in the emergency room in comparison to education and community~     volunteering only, in reducing high risk driving behaviors~   "
206979|NCT00852072|"~     Removal of large bile duct stones can be technically challenging at ERCP. Particularly, when~     the size of the stone is more than 1.2cm they are removed using a metal basket (lithotripsy).~     This can sometimes be technically challenging and may require more than one ERCP session.~     Recently, a balloon has been used to enlarge the opening of the bile duct (sphincteroplasty)~     to help easy removal of stones in one ERCP session. There are no studies comparing the~     lithotripsy and sphincteroplasty techniques. This randomized trial is designed to address the~     question of which technique is superior for bile duct stone extraction: lithotripsy versus~     sphincteroplasty.~   "
206980|NCT00852059|"~     This study determined to measure non-adherence assessed by the number of non-adherent days~     during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS).~      Study Design:~        -  prospective~        -  multi-centric~        -  open-label~        -  randomized~        -  active-controlled trial~   "
206981|NCT00852046|"~     Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and~     propofol while maintaining sedation in a mechanically ventilated patient in a general medical~     intensive care unit.~   "
206982|NCT00852033|"~     Alcohol abuse among college students is a significant and long-standing public health issue.~     The transition into college is marked by substantial increases in alcohol abuse and problems,~     suggesting the importance of interventions that take place prior to and immediately following~     matriculation. To date, early interventions with this population have yielded modest results~     with very little evidence identifying either the factors that are responsible for observed~     effects or specific individual or situational factors that qualify intervention efficacy.~     There is preliminary evidence for the efficacy of individualized feedback (IF) in reducing~     college student alcohol abuse. Additionally, a sizeable body of research with early~     adolescents and emerging work with college students point to the utility of parent-based~     interventions (PBI). The major aim of this research is to provide the first test of the~     unique and combined efficacy of these two successful interventions in reducing alcohol abuse~     among matriculating college students.~   "
206983|NCT00852020|"~     To test the compliance, tolerance, safety and to get preliminary insights into the efficacy~     of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and~     antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic~     heart failure (CHF) or chronic obstructive pulmonary disease (COPD).~   "
206984|NCT00852007|"~     This study investigates the use of the patients own immune cells to treat prostate cancer.~     Cells are taken from the patient and grown in the laboratory to become specialized immune~     cells called dendritic cells. Dendritic cells instruct other immune cells to recognize and~     attack foreign substances such as bacteria, viruses, or abnormal proteins on cancer cells. A~     protein called Tn-MUC-1 is added to the cells.This protein is present on prostate cancer~     cells. The modified cells are injected back into the patient, with the intention that the~     dendritic cells will instruct other immune cells to attack the prostate cancer cells.~   "
206985|NCT00851994|"~     The investigators are measuring novel proteins in the urine of patients having surgery.~   "
206986|NCT00851981|"~     Background: Alcoholic liver disease is one of the most important causes of chronic liver~     disease in this country. There is currently no treatment for chronic alcoholic liver disease~     other than abstinence. Hepatic methionine metabolism is abnormal in these patients and one of~     the consequences is depletion of S-adenosylmethionine (SAMe) levels, which can affect~     numerous important cellular processes. SAMe has been increasingly utilized for the treatment~     of liver diseases although the protective mechanisms remain unclear. A recent randomized~     double-blind trial using SAMe in patients with alcoholic liver disease and found improvement~     in 2-year survival in those with less advanced liver disease. However, important changes in~     methionine metabolism and histological changes were not included in the study. Aim: The goal~     of this study is to determine the effect of SAMe administration on key metabolic~     abnormalities of the methionine cycle and on the recovery from alcoholic liver disease.~   "
206987|NCT00851968|"~     Intraoperative bleeding remains a major concern during liver resection. Pringle maneuver is~     the most frequently used method to occlude inflow blood of the liver.However, experimental~     and clinical studies have shown than even short periods of clamping produce some degree of~     ischemia-reperfusion injury that can result in hepatocellular damage,this damage being~     especially important in patients with abnormal liver parenchyma such as steatosis and~     cirrhosis. The aim of this study was to evaluate whether the use of selective vascular~     clamping should be generalized to HCC patients and help to reduce the ischemia-reperfusion~     injury.~   "
206988|NCT00851955|"~     The investigators hypothesize that the CXCR2 ligands/CXCR2 biological axis plays an important~     role in promoting angiogenesis in PC; and that the genetic changes and the microenvironment~     of the tumor regulate the expression of CXCR2 ligands/CXCR2 in PC in order to potentiate~     their angiogenic phenotype. A corollary of this hypothesis is that the cell surface receptors~     (CXCR2) and the intracellular signaling pathways that mediate the angiogenic responses~     induced by ELR+ CXC-chemokines are potential targets for novel therapeutic interventions in~     PC.~   "
207028|NCT00851435|"~     The objectives of this open study are to assess the safety, tolerability, pharmacokinetics~     and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11~     after three separate administrations of KBPA-101 every third day in addition of standard of~     care antibiotic treatment.~   "
206989|NCT00851942|"~     Objectives:~      To establish valid serum total cortisol and salivary cut-offs for use with the short~     Synacthen test in patients with normal CBG concentrations.~      To investigate, using current assays, the effect of assay differences on the serum total~     cortisol cut-off.~      To explore the performance of these cut-offs in groups of patients with suspected adrenal~     insufficiency and high and low serum CBG concentration.~      Methodology: An ACTH test (250 micrograms iv ACTH1-24) will be undertaken in healthy~     volunteers, women taking an oestrogen-containing oral contraceptive pill (OCP), patients with~     adrenal insufficiency and patients with low serum albumin. Serum cortisol in the samples~     collected from healthy volunteers will be measured using GC-MS, Advia Centaur (Siemens),~     Architect (Abbott), Modular Analytics E170 (Roche), Immulite 2000 (Siemens) and Access~     (Beckman) automated immunoassays. The estimated lower reference limit for the 30 min cortisol~     response to ACTH, defined as the 2.5th percentile of log-transformed concentrations, will be~     determined in this healthy population and used as a cut-off in the patient groups studied.~   "
206990|NCT00851929|"~     Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension~     in patients with Sarcoidosis~   "
206991|NCT00851916|"~     The purpose of this study is to scientifically evaluate the effects (good and bad) of a new~     type of radiation treatment in patients with locally recurrent prostate cancer after prior~     radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from~     traditional radiotherapy by the application of smaller, more precisely controlled margins~     around the area targeted for full dose radiation, and far fewer treatments, using a much~     larger dose per treatment.~      This research is being done to see what advantages, if any, prostate radiosurgery may have~     over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity~     focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.~   "
206992|NCT00851903|"~     This study was the extension of the LANTU_C_02761 study named EASIE and identified as~     NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve~     patients treated with metformin and not adequately controlled).~      All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had~     the possibility to enter this extension study if they met the other inclusion criteria and~     did not present with any exclusion criteria.~      The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension~     study which consisted of a 12-week treatment period.~      The objectives of this extension study were:~        -  To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with~          metformin, insulin glargine and sitagliptin in patients not adequately controlled by a~          previous treatment with metformin plus either insulin glargine or sitagliptin.~        -  To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level,~          fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight~          and overall safety.~   "
206993|NCT00851890|"~     The purpose of this study was to assess the safety, tolerability, pharmacokinetics and~     antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus~     (HCV)-infected participants.~   "
206994|NCT00851877|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation and cisplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel~     albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation~     therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation~     together with cisplatin and cetuximab may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel~     albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab,~     and radiation therapy to see how well they work in treating patients with locally advanced~     stage III or stage IV head and neck cancer.~   "
206995|NCT00851864|"~     The purpose of this study is to evaluate the safety and efficacy of therapeutic~     anticoagulation with tinzaparin during pregnancy via weight-based dosing.~   "
206996|NCT00851851|"~     Measuring novel proteins in the urine of surgical patients that can be used to diagnose~     impending acute or chronic renal failure.~   "
206997|NCT00851838|"~     A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing~     strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is~     to evaluate the possibility to formulate PD solutions containing L-carnitine as an osmotic~     agent to partially replace glucose.~   "
206998|NCT00851825|"~     The discontinuation of mechanical ventilation (MV) and the recovery of spontaneous breathing~     can lead to important cardiovascular alterations due to changes in the intrathoracic~     pressure. The autonomic modulation assessed through heart rate variability (HRV) during~     weaning from MV and its impact on cardiorespiratory variables has not been well elucidated~     yet. To evaluate the effect of T-tube (TT) and pressure support ventilation (PSV) during~     weaning from MV on cardiorespiratory variables and heart rate variability.~   "
206999|NCT00851812|"~     The purpose of this study is to examine if exercise helps improve cancer-related fatigue.~      Hypothesis: A structured home-based walking and progressive resistance exercise program will~     be efficacious in relieving cancer-related fatigue, preventing aerobic and anaerobic~     deconditioning and skeletal muscle wasting, as well as improving inflammatory cytokine~     profiles in breast cancer survivors as well as those receiving radiation treatment.~   "
207029|NCT00851422|"~     Accurate cardiac output determination is a commonly used and important index of myocardial~     performance. The thermodilution method using a pulmonary artery catheter is the most common~     approach to cardiac output determination; however, placement of the pulmonary artery catheter~     is not without risk and at times can be problematic. Ultrasound dilution measurement has been~     shown to correlate with measured cardiac output in animal models and adults, but it has not~     been validated in pediatric patients. This study will validate the accuracy of ultrasound~     dilution measurements of cardiac output to thermodilution measurements of cardiac output in~     pediatric patients.~   "
212038|NCT00784940|"~     To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX~     plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving~     trial therapy.~   "
207000|NCT00851799|"~     The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV-infected~     people who have never received anti-HIV therapy be treated with a triple drug regimen~     (commonly called combination antiretroviral therapy, cART). Since the introduction of cART,~     morbidity and mortality among HIV-infected patients has been dramatically reduced. However,~     metabolic, skeletal, and cardiovascular diseases have been increasingly reported among~     HIV-infected patients and may be attributable, in part, to the direct effects of cART. Much~     of our understanding of the development of these diseases, risk factors, and consequences of~     these disorders has been derived from clinical studies of HIV-infected persons receiving~     older antiretroviral agents.~      A5260s was designed to examine the contributions of HIV-disease related factors and impact of~     newer antiretroviral drugs on the development of metabolic (such as blood vessels, blood~     sugar, cholesterol), skeletal, and cardiovascular diseases in people who have never received~     anti-HIV therapy. A5260s is a prospective substudy of a phase III randomized clinical trial~     A5257 (see ClinicalTrials.gov identifier: NCT00811954). A5257 was designed to look at~     different combinations of anti-HIV drugs that do not contain the medication efavirenz (EFV)~     and how well these drug combinations work to decrease the amount of HIV in the blood and to~     allow immune system recovery in people who have never received anti-HIV therapy. A5257 also~     examined drug tolerability and safety for the various drug combinations.~   "
207001|NCT00851786|"~     Herpes zoster, or shingles, is the result of a viral infection that causes a painful skin~     rash, usually in older people or people with suppressed immune systems like those infected~     with HIV. The ZOSTAVAX vaccine has been shown to reduce the number of infections and symptoms~     of herpes zoster infection in people over the age of 60. The purpose of this study is to~     evaluate the safety, tolerability, and immunogenicity of two doses of ZOSTAVAX in~     HIV-1-infected adults with conserved immune function (Cd4+ T cell counts >=200 cells/uL)~     virologically suppressed on potent combination antiretroviral therapy (ART).~   "
207002|NCT00851773|"~     This trial is conducted in Europe. The aim of this clinical trial is to assess and compare~     the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses~     of NN9535 in healthy male Japanese and Caucasian subjects.~   "
207003|NCT00851760|"~     The investigators proposed to assess the functional and anatomical outcomes of cataract and~     idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.~   "
207004|NCT00851747|"~     The primary objective of this study is to determine the efficacy of phosphatidylcholine and~     deoxycholate subcutaneous injections for localized fat removal.~      Subcutaneous injections of the study drug will be efficacious in decreasing localized fat~     deposits due to the known fat necrosis effects on fat tissue after study drug tissue~     incubation.~   "
207005|NCT00851734|"~     This is a first-in-man study for the purpose of determining the safety and tolerability of~     LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.~   "
207006|NCT00851721|"~     The purpose of the study was to determine the efficacy, safety, and health-related quality of~     life benefits with FEIBA NF prophylactic treatment as compared with on-demand treatment.~   "
207007|NCT00851708|"~     The aim of this interventional, prospective, randomized clinical trial is to evaluate the~     impact of the antioxidant N-acetylcysteine on oxidative stress in the first seven~     postoperative days and on renal function in the first three postoperative months in deceased~     kidney transplantation.~   "
207008|NCT00851695|"~     Asthma and chronic obstructive pulmonary disease (COPD) are diseases that affect a person's~     ability to breathe normally. People who do not receive enough vitamin D may have a higher~     risk of developing asthma or COPD. This study will examine previously collected blood samples~     of participants in three studies to determine whether people with low vitamin D levels have~     an increased risk of severe asthma or COPD.~   "
207009|NCT00851682|"~     The purpose of the present study is to find out if MRI techniques examining (1) the motion of~     water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow~     to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition~     of the prostate (MR spectroscopy), can be used to detect prostate cancer early and~     non-invasively. Localization of the cancer within the prostate would be of particular~     importance in focal cryoablation of prostate carcinoma which we hope to improve as a result~     of this project.~      Additional aim of the study is to correlate expression of genes believed to pay a role in~     prostate cancer with MRI findings.~   "
207010|NCT00851669|"~     The aim of this study is to evaluate an interpersonally-focused intervention (Interpersonal~     Psychotherapy) for women with co-occurring alcohol dependence and depression. A sub-protocol~     has been added to pilot the current study with men with co-occurring alcohol dependence and~     depression.~   "
207011|NCT00851656|"~     The purpose of this study is to evaluate the performance of the UpSpring Milkscreen Test for~     Alcohol in Breast Milk to detect alcohol in breast milk from lactating women.~   "
207012|NCT00851643|"~     This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV)~     L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS)~     and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s)~     of IMX for further studies of the octavalent HPV L1 VLP vaccine.~   "
207013|NCT00851630|"~     The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose~     combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a~     resource-limited setting, and (2) to assess the impact of delayed versus early initiation~     strategies for fixed dose combination zidovudine/lamivudine/abacavir on the rate of~     tuberculosis-associated immune reconstitution inflammatory syndromes.~   "
207014|NCT00851617|"~     Patients under threshold IMT show better conditions to weaning from mechanical ventilation~     than the control group.~   "
207015|NCT00851604|"~     The purpose of this study is to determine whether monitoring of levels of Serological Markers~     ProGRP, CgA, NSE and Pyruvate Kinase M2 are effective in the Evaluation of Diagnosis,~     Monitoring Therapeutic Effects and Predicting response to somatostatin analogues in Patients~     with Malignant Neuroendocrine Tumors.~   "
207030|NCT00851409|"~     Hereditary angioedema (HAE) is a disease characterized by recurrent tissue swelling~     affecting various body locations. Recent literature shows that patients with frequent attacks~     may benefit from long-term prophylaxis. This study aims to evaluate the safety and~     prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor~     (rhC1INH).~   "
207016|NCT00851591|"~     Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding~     an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor~     or simply stops. Termed Insufficient Milk Syndrome, this condition probably accounts for~     approximately 5-10% of the total population of breastfeeding mothers and includes many~     mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other~     unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy,~     grief, depression, and other problems, not to mention increased health risks to the infant.~      The most popular herbal remedy used around the world for increasing milk synthesis is~     fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family~     that is commonly sold, since the dried, ripe seed and extracts are used as an artificial~     flavor for maple syrup. When used orally in amounts commonly found in foods, it has been~     granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used~     by millions of women around the world to increase their milk supply, we have only one small~     case report which suggested it might actually increase the milk supply.~      In this one study, the authors found an approximate 40% increase in milk production, although~     the study was not blinded, nor did they use a control population. For these reasons, we still~     do not know with certainty if fenugreek works as a galactagogue.~      This study is designed to accurately determine if seven days of fenugreek will stimulate milk~     production in a selected group of subjects with poor milk supply. We hypothesize that the~     women enrolled in the test group will have increased milk production at the end of the 8-day~     study.~   "
207017|NCT00851578|"~     The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure~     Device in atrial fibrillation patients for which long term warfarin therapy is~     contraindicated.~   "
207018|NCT00851565|"~     To compare treatment outcome in patients with Crohn's disease with secondary loss of response~     to infliximab (i.e. initial good response follow by loss of response) treated according to~     current standards based only on clinical features versus treatment based on serum levels of~     infliximab and anti-infliximab antibody (Ab) status.~   "
207019|NCT00851552|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,~     such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     carry cell-killing substances to them. Giving bortezomib together with doxorubicin~     hydrochloride liposome and rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin~     hydrochloride liposome and rituximab works in treating patients with diffuse large B-Cell~     lymphoma that has relapsed or not responded to treatment.~   "
207020|NCT00851539|"~     The design of this randomized controlled trial (RCT) is to test the effectiveness of a~     post-test behavioral video in educating adolescents about HIV transmission and affecting~     their intentions to engage in risk-reduction behavior.~   "
207021|NCT00851526|"~     The COBIS registry is multi-center, real-world registry of drug-eluting stenting in coronary~     bifurcation lesions in South Korea.~      The aim of the study was to find out the current status of bifurcation drug-eluting stenting~     and determine the prognostic factors for long-term outcome in South Korea.~   "
207022|NCT00851513|"~     Pudendal neuralgia is a recent identified pathology, extremely invalidating, related to~     chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with:~        -  neuropathic pains treatment~        -  specific kinesitherapy~        -  Alcock's canal and sacrospinal ligament infiltrations under scan~        -  with diagnostic block~        -  local steroids injections~        -  and surgical decompression of pudendal nerve with transrectal approach.~      Only surgery was validated after a randomised protocol studying surgery versus abstention,~     performed and published by the CHU de Nantes. Many techniques have been proposed for~     realization of pudendal nerve infiltrations. The results of these infiltrations have never~     been published, and no randomised study had ever evaluated those results, even at short-run.~     Very few randomized studies have validated steroids infiltrations techniques in canal~     syndrome neuropathies.~      The primary objective of the investigators phase IV trial is to evaluate the efficacy of~     three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal~     ligament:~        -  group A: only local anesthetic (control arm)~        -  group B: local anesthetics associated with local steroids~        -  group C: local anesthetics associated with local steroids and important volumes of~          physiological serum~   "
207023|NCT00851500|"~     The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment~     of atherosclerosis.~   "
207024|NCT00851487|"~     Many children with non-severe pneumonia (cough and fast breathing) have neither clinical~     pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of~     antibiotics for these cases is leading to resistant strains of bacteria in the community.~     Evidence shows that almost 50% of antibiotic prescription is unnecessary.As over half of~     antibiotic prescription for ARI are not necessary since most of these infections are viral~     and do not respond to antibiotic therapy which will be source of resistance in the community.~      To address this issue the investigators conducted this randomized, double blind placebo~     controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe~     pneumonia taking into account all the necessary safety precautions for their well being.~      The study hypothesis was that the clinical outcome of children 2 to 59 months of age with~     cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is~     equivalent, whether they are treated with amoxicillin or placebo.~   "
207025|NCT00851474|"~     Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the~     new COstatus(R) system and these values will be compared with cardiac output values measured~     by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system~     will also be recorded.~   "
207031|NCT00851396|"~     The purpose of the study is to assess the relationship between vitamin D status and insulin-~     glucose dynamics in obese Adolescents. The study is intended to assess the difference in the~     insulin sensitivity before and after correction of vitamin D deficiency.~   "
207033|NCT00851370|"~     The objective is to conduct an exploratory study on the effect of Omalizumab on COPD patients~     with elevated IgE. Exploratory outcomes include to determine whether Omalizumab use: reduces~     exacerbations in COPD patients; or improves rescue medication use, decreases ICS use,~     modified Medical Research Council (MMRC) dyspnea score, St. George's Respiratory~     Questionnaire (SGRQ), 6-minute walk distance (6MWD), forced expiratory volume at one second~     (FEV1)(the latter 3 with BMI make up the BODE score), residual volume (RV), total lung~     capacity (TLC), exhaled nitric oxide (ENO), and determination C-reactive protein (CRP).~   "
207034|NCT00851357|"~     The primary purpose of this study is to determine the effects of distributing free nicotine~     replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims~     to:~        1. Test if sending active nicotine patches directly will lead to a higher quit rate,~          compared to a condition where the quitline assists the smokers to obtain patches by~          other means (e.g. via their health plans).~        2. Test if sending placebo patches directly will also lead to a higher quit rate.~        3. Test if quitline counseling increases the quit rate when the smokers already receive the~          nicotine patches.~   "
207035|NCT00851344|"~     A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of~     single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the~     efficacy and safety using an Environmental challenge chamber in male subjects with seasonal~     allergic rhinitis~   "
207036|NCT00851331|"~     Epilepsy is a frequent neurological disease in childhood, characterized by recurrent seizures~     and sometimes with major effects on social, behavioral and cognitive development. Childhood~     focal epilepsies particularly are age-related diseases mainly occurring during developmental~     critical period. A complex interplay between brain development and maturation processes and~     susceptibility genes may contribute to the development of various childhood epileptic~     syndromes associated with language and cognitive deficits. Indeed, the Landau-Kleffner~     syndrome (LKS), the continuous spike-and-waves during sleep syndrome (CSWS), and the benign~     childhood epilepsy with centrotemporal spikes (BCECTS) or benign rolandic epilepsy, are~     different syndromes that are considered as part of a single continuous spectrum of disorders.~     While genetic component in those three syndromes remains elusive, novel and high throughput~     genome analyzes could bring interesting insights into the possible genetic defects and~     pathophysiological mechanisms underlying and linking the various disorders associating~     epilepsy with speech and cognitive impairments.~   "
207037|NCT00851318|"~     The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as~     add-on medication to methotrexate over the long term in Japanese RA patients transferred from~     Study 275-08-001 (NCT00791999), and to evaluate the effects of different dosing regimens on~     the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20)~     responders who completed Study 275-08-001.~   "
207038|NCT00851305|"~     The purpose of this study is to determine whether endomicroscopy can improve the detection of~     Early Gastric Cancers (EGC).~   "
207039|NCT00851292|"~     The purpose of this study is to study the difference in prostate cancer between two prostate~     biopsy techniques, namely end-firing and side-firing. These differ in the angle at which the~     prostate is biopsied.~   "
207040|NCT00851279|"~     This is a prospective, non-randomized, multi-center clinical case series evaluating the~     outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects~     will be evaluated acutely and will be followed clinically at 1, 6 and 12 months~     post-treatment.~   "
207041|NCT00851266|"~     This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX~     (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX,~     a saponin-based adjuvant.~   "
207042|NCT00851253|"~     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects of stereotactic radiosurgery in~     treating patients with locally advanced or recurrent head and neck cancer.~   "
207043|NCT00851240|"~     Patients with adult-onset rheumatoid arthritis will be enrolled. They will be dosed with~     repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the~     treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to~     treatment groups will occur at random, and the actual treatment will not be revealed to the~     investigator or to the patient during the trial.~   "
207044|NCT00851227|"~     A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and~     moderate liver impairment versus subjects with normal liver function~   "
207045|NCT00851214|"~     This study is an observational prospective pilot trial that utilizes finger cuff non invasive~     hemodynamic monitoring (NexfinHD Monitor) to assess 4 different groups (CHF/COPD, Trauma,~     Sepsis, Stroke) of patients on arrival to the Emergency Department and to document the~     changes seen in these hemodynamics with acute therapies.~   "
207046|NCT00851201|"~     The purpose of this study is to address the Healthy People 2010 obesity prevention objective.~     This study will test the effects of a comprehensive family weight management program on the~     BMI z-score of 7-12 year-old children with a BMI > 85th percentile who receive primary care~     in a large municipal Bronx hospital. The intervention framework will draw on social marketing~     theory and the transtheoretical model of behavioral change to incorporate successful obesity~     prevention strategies. A two-arm randomized controlled clinical trial (RCT), which will~     enroll (n =506) 7-12 year old children with a > 85th BMI percentile, will compare the~     Experimental Intensive Intervention to a Standard (Control) Intervention. The Standard~     Intervention will receive: 1) an initial consult, which includes an overview of lifestyle~     goals, 2)quarterly follow-up, 3) and a monthly newsletter. The Intensive Intervention will~     add: 1)12 core group modules for parents (to address roles and skills) and for children (to~     enhance motivation and skills and to provide physical activity), 3) Tailored support using a~     toolbox approach from community health workers as extensions of the Family Weight~     Management professional education staff, and 4) monthly after-core follow-up groups. The~     study will determine if children randomized to the Experimental Intensive Intervention will~     have greater improvement in BMI change (z-scores) than those randomized to the Control~     Standard Intervention. The study will also evaluate the effects on the Experimental~     Intervention on lifestyle variables and assess intervention costs. The RE-AIM evaluation will~     address: Reach: How many of the eligible children/ families were referred and how many of~     those referred actually enrolled? We will use BMI data in the computerized medical records to~     evaluate the proportion and the appropriateness of the referrals. Efficacy/Effectiveness: How~     did the Experimental intervention affect BMI (changes in z-score), and key biomarkers when~     followed as planned? Adoption: How acceptable were the intervention(s) to the primary care~     medical team and the children/families in the pediatric clinics etc? (from process measures~     and post intervention surveys) Implementation: How many of the intervention activities were~     provided as planned? Quality control measures will be used to evaluate the integrity of the~     intervention(s). Maintenance: How much of the intervention effect is sustainable? Individual~     effects will be evaluated based on the 24 month follow data. Institutional effects evaluation~     will include the potential to maintain services using third-party coverage.~   "
207047|NCT00851188|"~     The current study aims to evaluate the effects of internet-delivered self-help CBT for~     insomnia through a randomised controlled trial. Adult persons with insomnia will be invited~     via a popular scientific website to fill out online questionnaires. Participants will be~     randomised into treatment groups or the waiting list. Participants will be measured 4, 16,~     and 40 weeks after intervention with the same questionnaires.~   "
207048|NCT00851175|"~     Rationale:~      Statins form a class of drugs that is widely prescribed for hypercholesterolaemia,~     specifically to reduce the risk on atherosclerosis by lowering LDL-cholesterol. Next to the~     effect for which the drug was originally developed, it became obvious that statins have~     several other beneficial effects. Such pleiotropic effects include the activation of~     ecto-5'-nucleotidase which can increase endogenous adenosine production (by dephosphorylation~     adenosine monophosphate into adenosine) and subsequently cause vasodilation. A recent study~     of Meijer et al (not yet published) showed that rosuvastatin significantly augments~     vasodilation after a brief period of ischemia (post occlusive reactive hyperaemia). However,~     it is not yet verified whether this increase in post occlusive reactive hyperaemia is truly~     caused by a rise of extracellular adenosine and subsequent adenosine receptor stimulation. In~     this study, the mechanism by which rosuvastatin augments post occlusive reactive hyperaemia~     will be investigated by blocking adenosine receptors with caffeine, a competitive A1 and A2~     adenosine receptor antagonist. Caffeine is a substance that can be safely used in normal~     concentrations to block the adenosine receptor.~      Hypothesis:~      The augmenting effect of rosuvastatin on PORH is caused by an increase of extracellular~     adenosine formation and this effect can be diminished by blocking the adenosine receptor~     using caffeine.~      Objective:~      To study the influence of caffeine on post occlusive reactive hyperaemia before and after 7~     days treatment with rosuvastatin.~      Study design:~      Open label cross-over design Study population: Healthy volunteers, 18-50 years of age~      Intervention:~      Eight volunteers will receive a 7 day treatment with rosuvastatin 20 mg daily before and~     after rosuvastatin treatment caffeine will be administrated intra-arterially.~      Main study parameters/endpoints:~      Forearm blood flow (FBF) will be measured as an indicator for post occlusive reactive~     hyperaemia (PORH).~   "
207049|NCT00851162|"~     The purpose of this study is to determine whether using mesenchymal stem cells will heal~     benign bone lesion defects faster than demineralized bone matrix~   "
207050|NCT00851149|"~     The purpose of this study is to investigate the contents in blood sampled from surgery site~     during hip replacement compared with blood sampled from abdominal aortic surgery. Is there~     any difference in pro-inflammatory cytokines (IL-1beta, IL-6, IL-8 and TNF-α), complement~     activation (C3a)?~   "
207051|NCT00851136|"~     This will be a multicenter, open-label study enrolling a total of up to 23 patients.~   "
207052|NCT00851123|"~     The purpose of the study is to evaluate the benefit of two different treatment approaches for~     the hemiplegic arm, modified Constraint-Induced Movement Therapy and task-related bimanual~     training.~   "
207053|NCT00851110|"~     Objectives of the study:~      This randomized multicenter phase II study compares the tolerability, toxicity and quality of~     life between two high-dose chemotherapy regimens based on cyclophosphamide, thiotepa and~     carboplatin.~      Regimen A: full dose CTC. Regimen B: two courses of CTC (tCTC) with 33% dose reduction.~      Primary endpoints are:~        -  Maximum degree of non-hematological toxicity.~      Secondary endpoint:~        -  Total number of hospital days.~        -  Quality of life evaluations during and following high-dose chemotherapy (up to 1 year).~        -  Effect of therapeutic dose monitoring of CTC or tCTC.~      Trial design:~      This investigation is a multicenter prospective randomized phase II study. Patients eligible~     for the study will be identified after mastectomy or wide tumor excision with axillary~     clearance. Following randomization, all patients will receive four courses of~     cyclophosphamide, epirubicin and fluorouracil (FEC). Patients with early progressive disease~     at any time will be taken off study. The first chemotherapy course must be given as soon as~     possible after the surgical procedure, preferably within 3 weeks, but not later than 6 weeks~     since primary surgery. After the third or fourth FEC course G-CSF is administered and~     peripheral stem cells will be harvested. All radiation therapy (including radiation therapy~     administered as part of a breast conserving strategy) must be postponed until all~     chemotherapy has been concluded.~      Questionnaires, comprising the Rotterdam Symptom Checklist (RSCL) and the Short-Form General~     Health Survey (SF-36) will be sent by mail before randomization, after chemotherapy, 3 months~     thereafter, further on every l/2 yr till at least 1 year follow-up as performed earlier. [6,~     28, 29].~      All patients will be randomized before the initiation of chemotherapy.~        -  The 'standard' treatment arm will include 4 courses of FEC followed by high-dose~          chemotherapy with a single course of full dose CTC followed by peripheral stem cell~          reinfusion. Subsequently, conventional external beam radiotherapy to the breast or chest~          wall and to the regional lymph node areas including the axilla and the parasternal area~          will be administered following guidelines of the individual center. Patients with~          hormone receptor positive disease will go on to receive 5 years of tamoxifen. Patients~          with receptor positive disease who have not entered menopause will be advised to undergo~          ovarian ablation as well.~        -  The 'experimental' treatment arm will be identical to the 'standard' one, except that~          the single course of CTC will be replaced by 2 courses of tCTC each followed by~          peripheral stem cell reinfusion.~   "
207054|NCT00851084|"~     The primary objective of the study is to estimate the progression-free survival rate at 12~     months for the two arms of the study.~      Secondary objectives include the evaluation of overall objective response rate to treatment,~     progression-free survival, overall survival, safety and documentation of potential~     immunogenicity of aflibercept.~      This study was a non-comparative randomized trial and was not powered for a comparison of any~     of the efficacy endpoints.~      Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and~     safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of~     non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a~     check on the similarity of the current patients to the historical controls with respect to~     clinical outcome when given FOLFOX6 treatment.~   "
207055|NCT00851071|"~     This study will compare the effectiveness that Cognitive Behavioral Therapy has on decreasing~     the amount of anxiety, as well as the number of inappropriate firings that a patient with an~     ICD may experience.~   "
207056|NCT00851058|"~     To determine the effectiveness of four group session of motivational counseling plus six~     hours of direct observations of the emergency department trauma services in comparison to~     four group session and six hours of community volunteering and also in comparison to four~     hours of education and 16 hours of community volunteering in reducing alcohol use and high~     risk driving behaviors and offenses among court referred 16-20 year old drivers.~   "
207057|NCT00851045|"~     The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab,~     both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of~     subject with metastatic colorectal cancer~   "
207069|NCT00850876|"~     Nasal continuous positive airway pressure can cause nasal side effects which can compromise~     compliance to therapy. Humidifiers can attenuate this effect. However, the mechanism by which~     humidified CPAP alleviates nasal symptoms has never been assessed objectively in OSA~     patients. Therefore, the purpose of this study is to examine the effect of humidified CPAP on~     nasal airway physiology with combined measurements of nasal resistance and level of~     inflammatory markers. The investigators' hypothesis is that the addition of heated~     humidification in CPAP decreases nasal airway resistance and nasal mucosal inflammation~     markers and thus, ameliorates nasal symptoms of OSAS patients.~   "
207195|NCT00849134|"~     This is a first-time-in-human study. The overall purpose of the study is to assess whether~     the drug is safe and well tolerated after single, increasing doses. At different doses, we~     will look to see how much of the drug gets into the bloodstream, how the drug is broken down~     and excreted and whether this is affected by the presence of food.~   "
207058|NCT00851032|"~     Primary Objective The primary objective of this study is to establish a program for the~     molecular profiling of patients with advanced cancer, with the goals of (1) providing a~     comprehensive characterization of the molecular profiles of individual patients and (2)~     correlating molecular profile with response to phase I therapies.~      Specimens will be received from the LAB07-0817 (Tissue Bank) protocol in the Department of~     Investigational Cancer Therapeutics. Note that this study is considered an umbrella protocol~     to systematically enroll phase I patients for molecular profiling analysis and correlate the~     results with treatment outcomes. The IMPACT trial is not a treatment protocol.~      Secondary Objectives~        1. To characterize advanced cancer by delineating genetic mutations, amplifications,~          translocations, and other defining molecular patient characteristics.~        2. To assess the antitumor effects of treatments by tumor responses using the World Health~          Organization (WHO) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria~          and/or any other clinical benefits, including progression-free survival and overall~          survival, demonstrated in phase I clinical trials.~        3. To correlate molecular profiles of patients with evidence of antitumor activity~          (complete remission, partial remission, prolonged stable disease, or overall survival)~          to define subsets of patients who will respond to specific therapies in clinical trials~          of novel agents.~        4. To correlate molecular profiles with toxicities induced by investigational agents to~          define subsets of patients who may or may not be candidates for treatment with these~          agents in the future.~   "
207059|NCT00851019|"~     Regular physical activity is important for the treatment of type 2 diabetes, but it is often~     not sustained for many reasons, including lack of interest. New video games that involve~     physical movement (exergames) may help in this regard. This study will compare the~     exergame Dance Dance Revolution (DDR) with traditional treadmill exercise on blood sugar~     control among sedentary, overweight or obese adults with type 2 diabetes.~   "
207060|NCT00851006|"~     The purpose of this study is to see if creatine, which is a naturally occurring chemical in~     the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.~     Creatine may have effects of interest in the brain. The reason for the MRI component of this~     study is to learn about new ways to see inside the brain. The investigators will use magnetic~     fields and radio waves to look at the brain and chemicals in the brain. The investigators~     hope that this technique will have medial use in the future.~      The primary hypothesis of the study is that oral creatine supplementation will have a~     beneficial effect as adjunctive therapy in female adolescents with MDD who are non-responders~     to an adequate trial of the SSRIs Fluoxetine or Escitalopram.~   "
207061|NCT00850993|"~     The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and~     effective in the treatment of hyperbilirubinemia in hemolyzing neonates.~   "
207062|NCT00850980|"~     The study will enroll patients that are already in AF and in which open-heart surgical~     intervention has been scheduled. In these patients AVN-VNS will be delivered briefly~     (minutes) after the incision as a proof-of-concept therapy, with concomitant monitoring of~     the effects on the ventricular rate.~   "
207063|NCT00850954|"~     Objectives:~      Exposure to secondhand smoke (SHS) is a major public health problem in the United States.~     Studies conducted in this country and internationally have irrefutably shown the causal role~     of passively inhaled cigarette smoke in development and exacerbation of acute and chronic~     diseases.~      The intervention will be delivered primarily in the form of fotonovelas based on smoking~     cessation programs previously developed, and the national telephone quit line specifically~     designed to serve Latino users. The intervention addresses the needs of Mexican American~     families (youth, middle-aged, and older adults). The evaluation study will be a randomized,~     controlled trial with assessments at baseline and at 6 and 12 months post-treatment. Up to~     125 households will be recruited from the established cohort of Mexican American households~     located in the Houston metropolitan area.~      The objectives for this study are as follows:~      1. Reduction in secondhand smoke exposure: The study will distinguish if a tailored~     intervention designed to address the needs of the target group will reduce objectively and~     subjectively measured secondhand smoke exposure of nonsmokers in MA households.~      1a. Develop tailored Fotonovelas for intervention implementation~      2. Smoking cessation: The study will identify if a tailored intervention designed to address~     the needs of the target group will help the primary smokers in the household quit smoking.~      3. Stages of change: The study will identify if the proposed intervention will have a~     significant impact on the primary smoker(s) progression through the stages of smoking~     cessation.~      4. Knowledge and attitudes: The study will identify if the proposed intervention will result~     in better knowledge and changed attitudes towards secondhand smoke exposure among members of~     MA households (smokers and nonsmokers) compared to standard care.~      5. Perceived health: The study will distinguish whether reduced exposure to secondhand smoke~     would improve perceived health.~   "
207064|NCT00850941|"~     The goal of this clinical research study is to create a registry (research database) of~     clinical data about patients who receive radiation therapy, with or without hormone therapy,~     to treat prostate cancer that has come back after surgical removal of the prostate. This~     treatment is standard and the actual treatment is not part of this protocol.~      The goal of this clinical research study is to create a registry (research database) of~     clinical data about patients who receive radiation therapy, with or without hormone therapy,~     to treat prostate cancer that has come back after surgical removal of the prostate. This~     treatment is standard and the actual treatment is not part of this protocol.~      Researchers want to collect data and use this registry to learn about the long-term status of~     prostate cancer after these treatments.~      This is an investigational study.~      Up to 500 patients will take part in this study. All will be enrolled at MD Anderson,~     Spartanburg Regional Healthcare System, and/or MD Anderson Cancer Center Albuquerque.~      Researchers want to collect data and use this registry to learn about the long-term status of~     prostate cancer after these treatments.~   "
207065|NCT00850928|"~     Postoperative cognitive dysfunction (POCD) can be a serious complication. The development of~     therapeutic strategies for the prevention and treatment of this condition requires the~     identification of subgroup of patients with the greatest incidence of POCD. Several~     retrospective analyses have raised the possibility that surgery is a risk factor for the~     accelerated progression of Alzheimer's disease (AD). Moreover, there is increasing evidence~     that inflammatory mechanisms are involved in the pathogenesis of AD. Major surgery can be~     associated with a profound systemic inflammatory response. Consequently, it is reasonable to~     suggest that there is a link between major surgery and the postoperative development of AD in~     patients who are already at high risk for this complication, e.g. the elderly with mild~     cognitive impairment. In addition, there are several laboratory investigations that suggest~     that anesthetic agents increase amyloid peptide levels as well as enhance oligomerization of~     these proteins. The significance of these findings, however, is unknown. This clinical study~     seeks to correlate perioperative inflammatory responses, perioperative changes in~     amyloid-beta protein levels (markers of AD) with neurocognitive and functional outcome in the~     elderly who are at risk for POCD. This knowledge does not exist, but is essential in the~     effort to plan perioperative care that can reduce the incidence of POCD as well as improve~     functional recovery.~   "
207070|NCT00850863|"~     COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only~     disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is~     obscure, therefore more insight is needed to design effective anti-inflammatory agents.~     Recently it has become clear that cigarette smoke-induced inflammation is not only present in~     the lungs but also in the blood, and that this systemic inflammation has important~     consequences for the clinical expression of COPD. The investigators hypothesize that healthy~     individuals who are susceptible to cigarette smoking demonstrate a higher and aberrant~     systemic inflammatory response to cigarette smoke. This susceptibility is caused by~     heterogeneous factors and is associated with various polymorphic genes that interact with~     each other and with the environment.~      Objective:~        -  To study systemic inflammation in individuals who are or are not susceptible to develop~          COPD.~        -  To characterize the switch to chronicity of the systemic inflmmatory response in COPD~        -  To determine whether the type and severity of the systemic inflammation contributes to~          the clinical outcome of COPD~        -  To compare between subjects who are or are not susceptible to develop COPD in peripheral~          blood, the corticosteroid responsiveness in vitro, and to unravel underlying mechanisms.~        -  To study the role of candidate genes that may play a role in the development of fixed~          airway obstruction, and to identify clues for patient's responsiveness to specific drugs~        -  To develop new biological and clinical markers for the early diagnosis and monitoring of~          COPD~        -  To define possible mediators involved in the early induction of COPD in susceptible~          smokers, and to define new drug targets~   "
207071|NCT00850850|"~     Recovery after general anaesthesia is often prolonged in the elderly. This group is~     particularly exposed to post-operative confusion. This has negative personal consequences as~     well as consequences for the postoperative care for these patients.~      The hypothesis is that physostigmine will decrease the amount of time in the post-anaesthesia~     care unit (PACU ), the postoperative amount of pain and shivering and finally post-operative~     confusion.~   "
207072|NCT00850837|"~     Topical microbicides, substances that kill microbes, are being studied to prevent sexual~     transmission of HIV and other disease pathogens. In the future, topical microbicides may be~     applied vaginally to prevent both acquisition and transmission of HIV and other sexually~     transmitted infections (STIs). The purpose of this study is to compare the safety of daily~     applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection~     and assess the effect of a microbicide candidate on the natural immunity women have to STI~     pathogens.~   "
207073|NCT00850824|"~     As type 2 diabetes prevalence increases in the United States, the burden of diabetes falls~     more on groups with greater barriers to care, such as language and cultural differences, and~     lower economic resources. Healthy People 2010 targeted diabetes as one of six diseases for~     the elimination of racial and ethnic health disparities. These disparities extend to the US~     Territory of American Samoa, where the proportion of adults >18 years with diabetes was 19.6%~     in 2002, compared to 6.4% of US adults. There have been no reported diabetes interventions in~     Samoans in the US. The overall purpose of this application is to translate recent advances in~     diabetes care into clinical practice for the American Samoan community by improving methods~     of health care delivery and methods of diabetes self management. We will conduct a randomized~     clinical trial to test the effectiveness of a community health worker (CHW) and primary-care~     coordinated intervention to provide outreach, education and support to 352 type 2 diabetes~     patients and their families in American Samoa. The CHW intervention will utilize~     evidence-based algorithms and protocols to prompt risk behavior interventions, communication~     with health care team, and visit schedule. The individual treatment action plans are also~     guided by the Precede-Proceed Model. The outcomes at a one-year follow-up will include~     glycosolated hemoglobin (HbA1c), cardiovascular disease risk factors, diet and exercise~     behaviors, and adherence to diabetes care guidelines. The study hypothesis is that diabetes~     patients in the CHW trial arm will have lower HbA1c levels, lower cardiovascular disease risk~     factor levels, increased exercise behaviors and healthy dietary intakes and greater adherence~     to diabetes care such as adherence to prescribed medications, keeping medical appointments~     for diabetes care and specialty referrals. The intervention builds upon best clinical~     practices for CHWs in diabetes care by translating effective strategies to American Samoans,~     while also extending prior CHW research, by using a model that is potentially replicable in~     other ethnic minority populations suffering the burden of diabetes.~   "
207074|NCT00850811|"~     This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel,~     0.01% when application is followed by light exposure.~   "
207075|NCT00850798|"~     Aims/hypothesis:~      Populations worldwide are aging and type 2 diabetes is common in individuals aged >80 years.~     The important issue that needs to be considered is whether tight glycemic control is benefits~     for elderly patients with type 2 diabetes. The benefits of intensive glucose control remain~     uncertain for the heterogeneous population of older diabetic patients due to a lack of~     clinical trial data evaluating the benefits of long-term intensive glucose control in older~     patients. This study is designed to provide reliable evidence on the balance of benefits and~     risks conferred by intensive glucose control in elderly patients with type 2 diabetes~     Methods: This is a prospective, randomized, open-labeled, controlled design to assess the~     benefits of treating elderly patients with type 2 diabetes. The study will include 208~     elderly patients with type 2 diabetes and follow-up for 5 years. Eligible patients are~     randomized to receive intensive (A1C <7.0%) or conservative (A1C around 8.0%) glycemic~     control. The primary study outcomes are a composite of macrovascular events and a composite~     of microvascular events, considered both jointly and separately. The secondary outcomes are~     death from any cause, death from cardiovascular causes, total coronary events, total~     cerebrovascular events, heart failure, peripheral vascular events, all cardiovascular events,~     and hospitalization for 24 hours or more.~      Expected results: This study is designed to provide reliable evidence on the balance of~     benefits and risks conferred by intensive and conservative glucose control in elderly~     patients with type 2 diabetes. Once completed, this trial will clearly influence the~     management of elderly patients with type 2 diabetes, regardless of the results.~   "
207076|NCT00850785|"~     This is a pilot single institution study of DRibble vaccination + GM-CSF in patients with~     stage IIIB or IV NSCLC who have undergone 0-1 chemotherapy regimens for metastatic disease.~     The primary objective of this trial is to evaluate immune responses induced by autologous~     DRibble vaccine in vivo and in vitro and against autologous and allogeneic lung cancer cells.~   "
207090|NCT00850603|"~     The objective of this trial is to study the administration of the Menomune vaccine given~     intradermally and low-dose subcutaneously versus standard subcutaneously. This study will~     describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard~     dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose)~     and a low dose (2/10th of standard dose) subcutaneously.~      The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal~     (ID) routes at different dosages~   "
207077|NCT00850772|"~     Ovarian cancer patients are often at risk of malnutrition because of weight loss, lack of~     appetite and reduced food intake. Being malnourished can contribute to the incidence and~     severity of cancer treatment side effects and increase the risk of infection. Currently~     patients with advanced ovarian cancer do not receive early nutrition using a feeding tube.~      The purpose of this study is to compare enteral nutrition along with standard post-surgery~     care against current standard post-operative care alone. This study will see if early~     nutrition using a feeding tube has an impact on length of hospital admission, recovery from~     surgery, complications from surgery, nutritional status and ultimately a reduction in~     treatment costs in people with Advanced Epithelial Ovarian Cancer (EOC). Primary Peritoneal~     Cancer (PPC) or Fallopian Tube Cancer. Nutritional support has been shown to ;~        -  Prevent and treat under-nutrition,~        -  Enhance anti-tumour treatment effects,~        -  Reduce adverse effects of anti-tumour therapies,~        -  Improve quality of life.~   "
207078|NCT00850759|"~     Pedestrian injuries are among the leading causes of morbidity and mortality in American~     children ages 7-8, but existing behavior-oriented interventions achieve only modest success.~     One limitation to existing interventions is that they fail to provide children with the~     repeated practice needed to develop the complex perceptual and cognitive skills required for~     safe pedestrian activity.~      Virtual reality (VR) offers a highly promising technique to train children in pedestrian~     safety skills. VR permits repeated unsupervised practice without risk of injury; automated~     feedback to children on success or failure in crossings; adjustment of traffic density and~     speed to match children's skill level; and an appealing and fun environment for training. The~     proposed research is designed to test the efficacy of virtual reality as a tool to train~     child pedestrians in safe street-crossing behavior.~      A randomized controlled trial will be conducted with four equal-sized groups of children ages~     7-8 (total N = 240). One group will receive training in an interactive and immersive virtual~     pedestrian environment. The virtual environment, already developed, has been demonstrated to~     have face, construct, and convergent validity. The second group will receive pedestrian~     safety training via video and computer strategies that are most widely used in American~     schools today. The third group will receive what is judged to be the most efficacious~     treatment currently available, individualized behavioral training at streetside locations.~     The fourth and final group will serve as a no-contact control group. All participants in all~     groups will be exposed to a range of field- and laboratory-based measures of pedestrian skill~     during baseline and post-intervention visits, as well as during a six-month follow-up~     assessment. Primary analyses will be conducted through linear mixed models designed to test~     change over time in the four intervention groups. We hypothesize all children in active~     learning groups will increase pedestrian safety skills, but the largest increase will be~     among children in the virtual reality group.~   "
207079|NCT00850746|"~     This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy~     adults.~   "
207080|NCT00850733|"~     The specific aim of this study is to evaluate the safety and efficacy of each of 2 dosages of~     BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of~     urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been~     adequately managed with anticholinergic therapy.~   "
207081|NCT00850720|"~     The goal of this study is to evaluate specific hormone levels in children undergoing heart~     surgery in order to identify patterns associated with any unstable vital signs. The data~     collected will provide preliminary answers to the question Are hormone values a determining~     factor for drug administration and dosing levels? and help establish the benefits of routine~     steroid and hormone administration. Sixty subjects will be enrolled. Blood samples will be~     drawn before the surgery,and again nine hours after surgery for analysis. Other patient data~     such as medications, vital signs, routine lab values and treatments will also be analyzed. As~     our current standard of care includes routine doses of steroids, we believe this study will~     increase our general knowledge and improve the care of these critically ill children. The~     study will also provide the foundation needed for grant support from the American Heart~     Association, allowing for future larger scale studies.~   "
207082|NCT00850707|"~     The aim of the present study was to investigate patients free of active infection and/or~     thrombosis to assess if the type of vascular access (AVF, AVG, TCC), could influence:~        1. the levels of serological markers of inflammation (CRP, IL-6, TNF-a);~        2. the degree of expression on monocyte surface of inflammation and immune response~          modulating molecules: CD14, CD32 and CD44.~        3. the amount of monocytic cells expressing a senescent phenotype (CD14 and CD32).~   "
207083|NCT00850694|"~     Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents.~     The investigators hypothesize vitamin D deficiency will be highly prevalent in obese~     adolescents and those who are vitamin D deficient will be more insulin resistant.~   "
207084|NCT00850681|"~     This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01%~     and it's vehicle on normal skin.~   "
207085|NCT00850668|"~     The purpose of this study is to evaluate the safety and side effects of a study product that~     contains recombinant modified peanut proteins (EMP-123) in healthy and peanut-allergic~     participants. This is a first in human study.~      As of November 2009, this study is no longer recruiting healthy volunteers and will only be~     recruiting individuals with peanut allergies.~   "
207086|NCT00850655|"~     This is a study of the genetics of malaria transmission by the mosquito vector in Africa,~     Anopheles gambiae. The study focuses on the mosquito vector, not the human subjects infected~     with malaria. DNA extracted from infected mosquitoes will be analyzed genetically by~     microsatellite and single-nucleotide polymorphisms (SNPs) to identify mosquito genes that~     control mosquito resistance to malaria parasites.~   "
207087|NCT00850642|"~     A randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect~     of treatment with GSK2190915, a FLAP inhibitor, as add-on to current inhaled corticosteroid~     therapy in patients with moderate to severe asthma with elevated sputum neutrophils.~   "
207088|NCT00850629|"~     The investigators here propose to perform a collaborative clinical research effort including~     a randomized controlled trial investigating the mechanisms of weight maintenance and their~     relation to a lifestyle intervention in children, adolescents and adults. The detailed~     investigation and analysis of the variability and dynamics of the endocrine circuits~     responding to a negative energy balance and weight loss will be accompanied and enhanced by~     specific clinical projects targeting peripheral and central-nervous aspects of hormonal~     counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and~     potential therapeutic approaches will be studied.~   "
207089|NCT00850616|"~     A study to assess the general safety and tolerability of the administration of the 3-dose~     regimen of the MRKAd5+6 trigene vaccine~   "
207168|NCT00849524|"~     This is a Phase II, open label, fixed dose, repeat injection, single institution study.~     Eligible subjects will receive up to six doses of Ad-ISF35 injected directly into a selected~     lymph node under ultrasound guidance. The primary goal is to determine and monitor clinical~     and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.~   "
207091|NCT00850590|"~     Studies investigating single doses of different NRL001 formulations showed~     formulation-dependent differences in exposure, even though they had similar effects on mean~     anal resting pressure (MARP). This study is a first step in investigating the hypothesis that~     a better balance between desired anal effects and undesired systemic effects can be reached~     with a NRL001-slow release suppository than with previously studied formulations.~      To this purpose, single doses of 5 to 15 mg, administered as 1 g and 2 g suppositories, are~     being investigated with regard to their pharmacokinetics and systemic effects (blood~     pressure, pulse rate, electrocardiographic heart rate).~   "
207092|NCT00850577|"~     The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab,~     both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects~     with recurrent or advanced non-squamous NSCLC~   "
207093|NCT00850564|"~     The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing~     Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will~     increase GH pulse height and will not affect insulin sensitivity.~   "
207094|NCT00850551|"~     This study will be performed at the University of Washington. Forty subjects with Cystic~     Fibrosis will be enrolled, with 20 randomized into the usual care arm and 20 randomized into~     the intervention arm. All subjects will be enrolled for 6 months and have 3 study visits. One~     at baseline, midpoint, and final. The intervention arm subjects may have more study visits~     depending on their respiratory symptoms.~      The intervention arm subjects will perform home spirometry twice a week with a PiKo-6 hand~     held spirometer. They will also have a home-based telemonitoring system connected to their~     phone line. They will be prompted twice a week to answer questions regarding their health via~     the telemonitor.~      Subjects who are not able to utilize the home-based telemonitoring system will answer the~     questions regarding their health via the internet from their home computer.~      If the subject's spirometry falls by greater than 10% from baseline or the CF respiratory~     symptoms change in 3 or more of the 8 respiratory symptoms captured by the telemonitor~     questionnaire, the subject will be called by the research staff and clinically evaluated by~     the study PIs within three days.~      The usual care subjects will continue with their routine care at the University of Washington~     CF Clinic.~   "
207095|NCT00850538|"~     The purpose of the study is to investigate protein and gene expression among damaged knee~     tissues. We will perform MRI's on subjects prior to total knee replacement to identify the~     location of bone marrow lesions. Connective tissues including tendon, ligament, and meniscus~     specimens normally discarded from total joint replacements will be used for live cell~     harvest, and protein and gene expression analyses of tissue or cultured cells.~   "
207096|NCT00850512|"~     Study phase: Phase II Investigational product, dosage, and route of administration:~     Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody~     (ibritumomab) covalently bound to the chelating agent tiuxetan. To prepare the active~     therapeutic agent [90Y]-ibritumomab tiuxetan, the antibody is chelated with the β-emitter~     yttrium-90 chloride immediately before intravenous administration. Treatment with~     [90Y]-ibritumomab tiuxetan is preceded by an infusion of rituximab (Rituxan, Mabthera) in~     order to optimize the biodistribution of radiolabeled antibody by depleting CD20 positive~     B-cells. Rituximab is a chimeric human/murine IgG1 monoclonal antibody. The Zevalin study~     regimen is given as an infusion of rituximab 250 mg/m2 and (where biodistribution imaging or~     dosimetry is compulsory) 185 MBq (5mCi) of [111In]-ibritumomab tiuxetan on Day 1 followed 7~     to 9 days later by a single dose of 14.8 MBq/kg (0.4 mCi/kg) of [90Y]-ibritumomab tiuxetan,~     maximal dose of 1184 MBq (32 mCi), preceded by 250 mg/m2 of rituximab.~      Reference product, dosage, and route of administration: Not applicable Indication: stage~     II-IV diffuse large B-cell lymphoma (DLBCL) patients after 4 cycles of CHOP21-Rituximab~     (CHOP21-R) Study objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan,~     as well as assessment of quality of life Patient population: Patients more than 60~     years-of-age with DLBCL after 4 cycles of treatment with CHOP21-R Study design: Prospective,~     multicenter, open-label study designed to treat patients with a sequential front-line~     treatment represented by: 4 cycles CHOP21-R plus Zevalin Duration of treatment: Four months~     for CHOP21-R and two treatment days one week apart followed by a 12-week safety period for~     Zevalin Duration of study: Estimated duration of study is 18 months Methodology: Primary~     efficacy parameter: Overall response rate and complete response rate. Secondary efficacy~     parameters: Overall survival, disease-free survival, health-related quality of life. Safety~     parameters: Vital signs, adverse events (AEs), hematology, blood chemistry, and~     immunoglobulin levels Number of study centers: Planned total of 10 study centers in Italy~     Total number of patients, statistical rationale provided: Expected total of approximately 55~     patients. The final sample size is based on the number of events observed for the primary~     efficacy endpoint as calculated in the sequential statistical model. Adverse events: AEs~     observed, mentioned upon open questioning and/or spontaneously reported will be documented.~      Planned start and end of recruitment: Start of recruitment: 19/12/2006. End of recruitment:~     04/11/2008.~      Manufacturer(s) of the investigational /reference product(s): Ibritumomab tiuxetan is~     manufactured by Biogen IDEC, San Diego, CA and Cambridge, MA, USA. The isotopes yttrium-90~     will be provided by European suppliers. There is no reference product in this study.~   "
207097|NCT00850499|"~     This is a randomized, open-label, active-control, multicenter Phase 2 study of~     VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed~     advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the~     2 treatment arms (55 subjects per arm).~   "
207098|NCT00850486|"~     The purpose of this study is to verify the efficiency of the HyperQ technology compared with~     standard ECG analysis in detecting exercise induced ischemia in women who are referred to~     coronary angiography.~   "
207099|NCT00850473|"~     This study is being done to determine if a picture taking test of the heart, positron~     emission tomography/computed tomography (or cardiac PET/CT), can identify the blockages in~     the heart arteries that lead to heart attacks when compared to the standard of heart~     catheterization.~   "
207100|NCT00850460|"~     The proposed study will focus on possible effects of statins on muscle strength and why they~     become tired more easily, quality of life, and measurements to understand why muscles are not~     able to fully utilize fats. The investigators are specifically interested in statin users and~     the impact of muscle symptoms on daily activities and quality of life.~      This study hypothesize that patients with likely statin-associated myopathy have a metabolic~     dysregulation in fuel utilization such that compared to patients continuing statins, those on~     placebo will show:~        1. improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36)~          scores (primary end point)~        2. alleviation of muscle symptoms,~        3. increased utilization of fatty acids as a fuel source reflected by the metabolic test~          results~        4. decreased intramyocellular lipid (IMCL)~        5. improved insulin sensitivity.~   "
207169|NCT00849511|"~     The circadian system with its centre in the hypothalamus is involved in migraine~     pathophysiology. Whether it plays a pivotal role is not clarified. The investigators~     postulate that a destabilized circadian system may increase migraine attack susceptibility,~     and that stabilization by supplying melatonin a migraine preventive effect will be achieved.~      A previous open label study has shown effects that certainly warrant a placebo controlled~     study.~   "
207101|NCT00850447|"~     The purpose of this study is to gather feasibility data on cognitive remediation therapy~     (CRT) as an alternative intervention for PTSD. CRT is a standardized intervention that~     involves performing cognitive exercises to improve attention, processing speed, and memory~     through practice. Although the primary objective will be to determine the effect of CRT on~     cognitive functioning in PTSD, data on PTSD symptom severity and other clinical measures will~     also be examined to assess whether and to what degree cognitive alterations and symptom~     severity might be linked. CogPack, a computer-based form of CRT, would be employed for this~     project. Participants will be randomized to receive CRT or to play the video game Tetris as a~     control condition.~   "
207102|NCT00850421|"~     The purposes of this study are to assess whether subjects treated with BOTOX will:~        1. have a decrease in the frequency and intensity of migraine headaches~        2. experience improvements in quality of life~        3. experience a reduction in the frequency of health care services obtained.~   "
207103|NCT00850408|"~     Weakness of the arm and hand results in long-term disability for many persons who suffer a~     stroke. After the initial recovery phase, only limited gains are achieved by retraining the~     weak limb to perform daily tasks. However, new treatment strategies such as repetitive~     transcranial magnetic stimulation (rTMS) show promise for enhancing motor recovery after~     stroke. rTMS is a noninvasive technique for modifying brain activity that aims to improve~     motor function by correcting abnormal patterns that occur after stroke. We believe that~     giving rTMS right before a therapy session will prepare the brain so that the patient is~     better able to participate in and benefit from training of the hand and arm. The goal of this~     study is to test how well this new strategy works to improve recovery in people who have mild~     to moderate weakness of the arm and hand after stroke.~      Participants will receive magnetic stimulation of the movement area of the brain just prior~     to arm and hand training for a series of eight sessions. We will evaluate changes in hand and~     arm function after the intervention and one month later to see if the changes are maintained.~     We will also test whether some groups of people benefit more than others from the~     intervention. If improvements in hand and arm function are observed after the intervention,~     we will test it more rigourously in a future clinical trial in which participants are~     randomly assigned to different treatment conditions. This research will show whether brain~     stimulation can be used to improve the effectiveness of rehabilitation care.~   "
207104|NCT00850395|"~     Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical~     practice and obtain information about the quality of life of patients using CELSENTRI®.~   "
207105|NCT00850382|"~     This is a Phase Ib/IIa open-labeled multi-center trial evaluating the feasibility of~     dasatinib given after standard induction therapy with daunorubicin (DNR) and cytarabine~     (ARA-C), after consolidation therapy with high-dose cytarabine (HDAC), and as single agent in~     a one-year maintenance therapy in patients with newly diagnosed CBF AML.~      82 patients with newly diagnosed CBF AML will be enrolled at AMLSG study centers.~      All AML patients will be assessed for the CBF fusion genes via the central laboratory of the~     AMLSG within 48 hours of diagnosis of AML, and only patients with CBF AML will be enrolled~     into the study.~   "
207106|NCT00850369|"~     Pulmonary hypertension, a complication associated with an increased risk of death, is common~     in patients with sickle cell disease. Despite its frequency, there remains no standard~     treatment for this complication in patients with sickle cell disease.~      In this small study, the investigators will evaluate the effect of monthly transfusion of red~     blood cells to patients with sickle cell disease-associated pulmonary hypertension. The~     investigators speculate that by increasing the hemoglobin level and decreasing the amount of~     sickle red blood cells, these patients would experience improvements in their PHT.~   "
207107|NCT00850356|"~     The purpose is to determine the economic, clinical and quality of life outcomes of bariatric~     surgery and describe the consequences of protracted wait-times (~ 2 years) for this~     procedure.~   "
207108|NCT00850343|"~     The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol~     when administered without coadministration of methotrexate over the long term in Japanese RA~     patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of~     different dosing regimens on the safety and efficacy of certolizumab pegol in American~     College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.~   "
207109|NCT00850330|"~     A drug interaction (DI) is the mutual action of two drugs in a way that they can increase~     their action, even to a toxic level, or reduce it to its minimum.~      People elder than 65 years old have theirs biological ability to metabolized and eliminate~     drugs impaired. Even more, they tend to suffer from many diseases, are treated for many~     physicians, and receive many drugs for those conditions. If hospitalized older people are~     prone to receive a greater number of drugs. This scenario is the worst to suffer from adverse~     drug events and DI, which in turn compromise more the health and even life of hospitalized~     older people.~      Many computerized strategies have been developed to prevent those problems. In this trial the~     investigators use on line software to early detect DI that could endanger health or life of~     hospitalized older patients.~   "
207110|NCT00850304|"~     Our purpose in this study is to explore the feasibility of treatment of non promyelocytic~     Acute myeloid leukaemia on elderly patients. We select ten patients with age further than 60~     with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten~     days in month. We will assess overall response rate and overall survival in end of one year.~   "
207111|NCT00850291|"~     Including 89 randomised patient, the studies aim is to determine whether an economisation~     and/or improvement in terms of operating time, drainage fluid, blood loss, time of~     hospitalisation can be found using an electrosurgical sealing device versus traditional~     surgical methods such as stitches an ligations.The study is performed for patients undergoing~     partial pancreatoduodenectomy.~   "
207112|NCT00850278|"~     The primary objective of this study is to assess the efficacy of the radiopharmaceutical~     3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a tracor of cell proliferation, using Positron~     Emission Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50~     patients with different type of brain tumors.[F-18]FLT PET imaging will be compared to the~     current used imaging techniques of MRI, spectroscopy imaging, PET imaging using [11C]MET~     tracer, immunohistochemical analysis and clinical parameters.~   "
212054|NCT00784732|"~     This study will compare the effectiveness of QAV680 against placebo in treating the symptoms~     of seasonal allergic rhinitis in an Environmental Exposure Chamber.~   "
207113|NCT00850265|"~     Combined inhaled treatment with long acting adrenergics and steroids in an unique inhaler~     plays an important role in the management of non-mild asthma. Some studies have demonstrated~     that the use of spacers achieve better lung deposition and decrease the number of side~     effects. Recently a new combined treatment for asthma has been developed (extrafine~     formoterol plus beclomethasone dipropionate). The small size of the extrafine particles of~     this new combination get the small airway and theorically improve their positive effect. Some~     authors have stated that the use of a spacer with extrafine particle could decrease the~     effectiveness of this treatment due to the adhesion of particles on the walls of the spacer~     because of the electrostatic characteristics of plastic spacers. However, there are no~     clinical or functional studies demonstrating the role of this phenomena in the control of~     asthmatic patients. The investigators' hypothesis is that the benefit of using spacers with~     this new treatment is at least equal in magnitude than the loss of efficacy because of the~     adhesion of particles on the wall of the spacer and then the investigators hypothesized that~     the use of spacer with extrafine formoterol-beclomethasone do not suppose a decrease in~     clinical or functional control in stable moderate-severe asthma patients.~   "
207114|NCT00850252|"~     This study will assess the safety and efficacy of a completely autologous and completely~     biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous~     fistula for dialysis access.~   "
207115|NCT00850239|"~     The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as~     evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety~     and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26~     weeks.~   "
207116|NCT00850226|"~     This study proposes to compare the effectiveness of an acceptance-based intervention and a~     cognitive control-based intervention for coping with test anxiety in nursing students during~     the HESI (Health Education Systems, Inc.) examination.~      Subjects will be randomized to receive either the CT or the ACT condition. In both~     conditions, subjects will receive an education on test anxiety to inform them about what test~     anxiety is and why it occurs. Then, the different conditions will receive the respective~     treatment of either CT or ACT. The study is considered minimum risk because the nursing~     students will only be exposed to an amount of anxiety that is typical of their testing~     experience. Both conditions will meet three times, with each session lasting approximately~     one and a half hours. The purpose of the treatment is to provide subjects with tools to help~     them cope with their test anxiety.~   "
207117|NCT00850213|"~     The Redes registry is set up to document the overall clinical performance and costs of the~     Endeavor Resolute coronary stent in a real life subject population of 450 patients that~     require a stent in Spain. Primary objectives are the overall cost for patients during initial~     hospitalization and at 1-year follow-up, as well as the MACE rate at 30 days, 6 months and 12~     months post procedure.~   "
207118|NCT00850200|"~     The purpose of this study is to reduce the risk of radiation related side effects and~     complications by treating with radiation (protons or photons) that exposes less of normal~     organs to low dose radiation.~   "
207119|NCT00850187|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold~     in patient with Knee cartilage defects and osteoarthritis~   "
207120|NCT00850174|"~     The objective of this study is to evaluate the comparative bioavailability between~     Oxcarbazepine 600 mg Tablets (test) and Trileptal® 600 mg Tablets (reference) after a~     single-dose in healthy subjects under fasting conditions.~   "
207121|NCT00850161|"~     The purpose of this study is to determine if glucose peaks higher and earlier after a meal~     when a patient is given intranasal insulin instead of conventional insulin treatment.~   "
207122|NCT00850148|"~     This study will be performed on patients who come to labbafinejad ophthalmic clinic from 20~     March 2008. Keratoconus diagnosis will be determined by clinical finding in slit lamp,~     keratometery and topographic characteristics. Patients will be randomly placed in group A and~     B. In group A, Anwar surgical method and in B, Melles surgical method, will be done. This is~     not a blind study due to surgeons' knowledge. All patients will receive Btamethazone drop and~     Chloramphenicol every 6 hours and will be tapered in two months. In the end anatomical~     results, complications, BCVA, UCVA, astigmatism, endothelial cell numbers will be compared in~     two groups by using specular microscopy. Contrast sensivity, central corneal diameter,~     interface wrinkling and opacity will be measured by metrovison, Confoscan, Photoslit in~     months 3, 6, 12, respectively and will be evaluated afterwards.~   "
207123|NCT00850135|"~     Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than~     expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels.~     the one-hour glucola test is currently used to screen pregnant patients for gestational~     diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour~     later. We wish to compare 7-day continuous glucose monitoring to the one-hour glucola test,~     and determine which one correlates better with adverse pregnancy outcomes as well as which~     one more accurately identifies patients at risk for adverse pregnancy outcomes.~   "
207124|NCT00850122|"~     This is a phase I open label multi-dose study to investigative the pharmacokinetics and~     safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected~     sepsis. There will be two cohorts of 6 infants each: 1) >48 hours of age and ≤28 days and 2)~     >28 days of age and <121 days of age. The study requires administration of the study drug~     over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained~     over the 2 days of drug administration. The risks are reasonable vs. the benefits and have~     been minimized appropriately. There may be benefit to the subjects (administration of~     empirical antimicrobial therapy), and information from the study may benefit a large number~     of other infants in whom the drug is currently being administered despite the lack of PK data~     in this population.~   "
207125|NCT00850096|"~     The purpose of this study is:~        -  To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia,~          assessed by continuous glucose monitoring data and serum fructosamine levels in patient~          volunteers with Type 2 Diabetes.~        -  To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient~          volunteers with Type 2 Diabetes~   "
212055|NCT00784719|"~     A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in~     subjects with dry eye.~   "
207126|NCT00850083|"~     Objective To evaluate the accuracy of data acquisition by Health e pod device in measurement~     of body temperature, to compare it to a standard body temperature measure equipment About 400~     consecutive patients admitted to PEU in Assaf Harofeh Medical Center will compile the Study~     Population.~      Basic vital signs will be recorded on admission and during hospitalization as per the PEU~     policy and not in particular for this study.~      As a part of routine check-up all admitted patients undergo body temperature measure (oral or~     rectal - as per the PEU policy and with PEU devices).~      Following an explanation and patient agreement, eligible patients (and their legal guardian)~     will sign informed consent and enter the study. The health e pod device will be applied to~     measure body temperature, immediately after the standard temperature measure has been~     performed by the PEU professional.~   "
207127|NCT00850070|"~     This study is intended to provide a definitive test of the hypothesis that elevating~     sapropterin (tetrahydrobiopterin, a cofactor for several key brain enzymes)concentrations in~     the CNS will result in measurable improvements in core symptoms of autism in young~     individuals, under age 6 years. The study will entail a double-blind, placebo-controlled~     16-week intervention.~   "
207128|NCT00850057|"~     Primary Objectives~        -  To determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35)~          when it is injected directly into the lymph nodes of patients with CLL or SLL.~      Secondary Objectives~        -  To determine and monitor clinical and biological responses in patients treated with~          injections of Ad-ISF35.~        -  To determine how ISF35 works in CLL/SLL patients' cells.~   "
207129|NCT00850044|"~     The purpose of this study is to determine the pharmacokinetic and safety profiles of an~     experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.~   "
207130|NCT00850031|"~     The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will~     provide an effective method for the correction of presbyopia in patients who have normal~     distance vision but need a correction such as glasses or contact lenses to see clearly at~     near.~   "
207131|NCT00850018|"~     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease~     that can cause intense pain episodes and may lead to organ failure. Preliminary studies have~     shown that adults with SCD may have brain abnormalities that contribute to problems with~     cognitive functioning, including attention and memory difficulties. This study will use brain~     magnetic resonance imaging (MRI) and neuropsychological testing to examine the differences in~     cognitive functioning in adults with SCD who are treated for anemia with monthly blood~     transfusions for 6 months versus adults with SCD who receive usual care for 6 months.~   "
207132|NCT00850005|"~     This project addresses a vexing problem that has alluded the best efforts of the~     medical/scientific community: treatment of resistant neuropathic pain. Neuropathic pain is~     common and includes conditions such as diabetic neuropathy, post herpetic neuralgia and post~     stroke pain and is believed to affect at least 3% of adults. Surveys of patients with~     neuropathic pain indicate that 60% do not receive adequate relief with current treatment.~     Results from recent laboratory and human studies reveal a new approach to treatment. This~     approach is based on the findings that neuroinflammation appears to be involved in~     development and maintenance of neuropathic pain. This study explores the effects of an~     immune-modulating blood-derived product, intravenous immunoglobulin (IVIG), in treating~     neuropathic pain. IVIG is thought to reduce neuroinflammation contributing to neuropathic~     pain. If successful, the study will provide important insights into pain mechanisms and a~     better understanding of how IVIG relieves neuropathic pain.~      Hypotheses:~        1. Reduction in neuroinflammation (NI) markers will co-vary with clinical indicators of~          pain relief~        2. Patients with higher levels of markers of NI will be more likely to respond to IVIG~   "
207133|NCT00849992|"~     Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to~     compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data,~     histology (skin analysis), epidemiological data and follow-up data.~   "
207134|NCT00849979|"~     The goal of this study is to learn more about the symptoms that may occur in patients with GI~     cancer. The types of GI cancer being studied are cancers of the stomach, liver, pancreas,~     colon, and rectum. Researchers want to test a newly-designed questionnaire called the M. D.~     Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) questionnaire.~   "
207135|NCT00849966|"~     The investigators' study will involve the administration of either placebo or celecoxib to~     children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief, impact~     on quality of life and side effect profile.~   "
207136|NCT00849953|"~     A prospective, post-approval registry study assessing subject rhinosinusitis symptomatic~     status over time following treatment with FinESS Sinus Treatment using self-administered~     quality of life survey data.~   "
207137|NCT00849940|"~     The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared~     Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal~     organs (StO2). This is a measure of the amount of oxygen carried by the blood within the~     internal organs. In addition the study will assess the degree of similarities between StO2~     and mean mixed venous oxygen saturation - a measure of the amount of oxygen carried in the~     blood returning to the heart.~   "
207138|NCT00849927|"~     Objective: Symptomatic pan-labral or circumferential (360 degree) tears of the glenohumeral~     labrum are an uncommon injury. The purpose of this study is to report the prospective~     surgical results of circumferential lesions of the glenoid labrum using validated outcome~     instruments.~      Methods: From July 2003 to May 2006, 41 shoulders in 39 patients with mean age of 25.1 years~     (range, 17 to 38) were prospectively enrolled in a multi-center study (3 surgeons) and~     treated for a circumferential (360-degree) lesion of the glenoid labrum. There were 34 men~     and 5 women, all with a primary diagnosis of pain and recurrent shoulder instability. All~     patients underwent arthroscopic repair of the circumferential labral tear with a mean of 7.1~     suture anchors (range, 6 to 9). The outcomes in 39 of 41 shoulders (92.7% follow-up) were~     assessed at a mean final follow-up of 31.8 months (range, 24 to 53 months) with VAS pain and~     instability scales (0 to 10), a physical examination, the Single Assessment Numeric~     Evaluation Score (SANE), the American Shoulder and Elbow Surgeons Score (ASES), and the SF-12~     score.~   "
207170|NCT00849485|"~     The objective of this study is to compare the rate and extent of absorption of a test~     formulation of Levetiracetam tablets versus the reference Keppra® administered as a 1 x 750~     mg tablet under fed conditions.~   "
207139|NCT00849914|"~     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length,~     capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs~     (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of~     complementarity. miRNAs have recently been shown to play pivotal roles in diverse~     developmental and cellular processes and linked to a variety of skin diseases and cancers. In~     the present study the expression profiles for the two most important miRNA processing enzymes~     Dicer and Drosha of actinic keratoses, basal cell carcinoma and squamous cell carcinoma are~     compared to healthy skin tissue.~   "
207140|NCT00849901|"~     The purpose of this study is to assess whether duloxetine is superior to placebo in the~     treatment of children and adolescents with major depressive disorder (MDD)~   "
207141|NCT00849888|"~     The study purpose is to determine if thymus tissue cultured in a serum-free (SF) solution is~     a safe and effective treatment for atypical and typical complete DiGeorge anomaly. [Funding~     Source - FDA OOPD]~   "
207142|NCT00849875|"~     The purpose of this clinical trial is to find out how successfully, patients with progressive~     metastatic cutaneous melanoma, are able to develop an immune response to injections with the~     immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate~     the safety of this combination.~   "
207143|NCT00849862|"~     The objective of this study is to compare the rate and extent of absorption of a test~     formulation of Levetiracetam and the reference Keppra® administered as a 1 x 750 mg tablet~     under fasting conditions.~   "
207144|NCT00849849|"~     Previous gestational diabetes (GDM) predisposes affected women to diabetes. Pregnancy, in~     essence, serves as a metabolic stress test and uncovers underlying insulin resistance and~     ß-cell dysfunction. Cumulative incidence rates of type 2 diabetes (DM2) among women with a~     history of GDM vary widely depending on the length of follow up and the underlying risk of~     diabetes in the population. Like DM2, the incidence of postpartum diabetes appears to be~     increasing The cumulative incidence of DM2 varied from 2.6 to > 70% in studies with~     postpartum follow-up ranging from 6 weeks to 28 years. Among women with a history of~     gestational diabetes, it is generally accepted that race, age, parity, family history of~     diabetes, pre-pregnancy weight, postpartum obesity, and weight gain are risk factors for~     developing DM2. Other suspected risk factors include smoking, physical inactivity, diet, and~     drugs that adversely affect glucose metabolism. Despite the high and increasing rate of DM2~     in Louisiana, the medical community does not have reliable estimates of the number of woman~     living in southern Louisiana who develop diabetes subsequent to GDM. At Woman's Hospital, the~     investigators had 8246 deliveries in 2007; 7873 mothers (95% of deliveries) were either~     African American or Caucasian. Of this group of women, 665 were diagnosed with gestational~     diabetes mellitus. Thus, around 8.5% of the African American and Caucasian women delivering~     babies at Woman's Hospital in 2007 had a glucose abnormality. The incidence of diabetes and~     impaired glucose metabolism in the immediate postpartum period and within 12 months after~     delivery in this population is unknown. There are no long-term studies performed in Louisiana~     that have compared the benefits of different screening strategies or evaluated an optimum~     testing frequency after GDM to reduce the rate of DM2 and cardiovascular disease (CVD) in~     these high-risk women. The investigators plan to use this study as an outreach effort to~     provide screening for previous gestational diabetic mothers without adequate medical coverage~     following delivery.~   "
207145|NCT00849836|"~     The purpose of this study is:~        -  To define The differences of bio-chemical phenotypes in chronic airway inflammatory~          diseases.~        -  To identify novel biomarkers in chronic airway inflammatory diseases as a screening,~          diagnostic, or monitoring marker.~   "
207146|NCT00849823|"~     The purpose of this study is to test if sexual health interventions can reduce the incidence~     of STIs among African American teens (15 to 21 years old). By doing this study, we hope to~     help African American teens improve their condom use skills and encourage them to use condoms~     more frequently. If the number of STIs in this population can be decreased, the health of~     African American teen males will greatly improve. We also believe that sexual partners~     (typically African American teen females) will also benefit.~   "
207147|NCT00849810|"~     The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour~     ambulatory blood pressure characteristics and basal metabolic rates in patients with~     hypertension.~   "
207148|NCT00849797|"~     The objective of this study is to compare the rate and extent of absorption of a test~     formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose~     under fed conditions.~   "
207149|NCT00849771|"~     The purpose of this study is to contrast and evaluate the functional outcome of patients with~     operative vs. nonoperative treatment of scapula fractures. The specific aim of this project~     is to monitor the return to function of patients in both the operative and nonoperative~     cohorts.~      The potential impact is a clearer set of choices in treatment options for this type of~     injury.~   "
207150|NCT00849758|"~     The goal is to study the biology of aging in breast cancer patients, and to study the impact~     of chemotherapy on aging related blood biomarkers.~   "
207151|NCT00849745|"~     Autoimmune diseases present a special challenge to clinicians and the aim of this protocol is~     to serve as a last-line effort for patients with unmanageable disease. The primary purpose of~     this study is to assess feasibility in terms of toxicity and engraftment of a less toxic,~     nonablative conditioning regimen of Campath-1H, moderate dose fludarabine, and~     cyclophosphamide for patients with severe autoimmune diseases.~   "
207152|NCT00849732|"~     This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine.~     In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose~     (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10^10~     vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10^9~     vp/d, at 1x10^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1~     Gag Vaccine will also be measured.~   "
207171|NCT00849472|"~     The purpose of this study is to determine whether the treatment of a doxorubicin in~     combination with cyclophosphamide followed by a combination of pazopanib in combination with~     paclitaxel prior to surgery results in a pathological complete response in females with~     breast cancer.~   "
207172|NCT00849459|"~     RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body~     build an immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in~     treating women with metastatic breast cancer.~   "
207194|NCT00849147|"~     Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family~     members or unrelated donors with a similar type of bone marrow usually donate their bone~     marrow to the transplant patients. This study will evaluate the effectiveness of a new type~     of bone marrow transplant—one that uses lower doses of chemotherapy and bone marrow donated~     from family members with only partially matched bone marrow—in people with leukemia or~     lymphoma.~   "
207153|NCT00849719|"~     After major surgery, such as abdominal or thoracic surgery, the majority of patients~     experience moderate to severe pain that may not be optimally controlled. Inadequate pain~     relief may lead to complications that can hinder rehabilitation and slow recovery. Morphine~     (MO) is the most commonly used opioid for the treatment of post-surgical pain (14). The~     preferred method of administration nowadays is intravenous patient-controlled analgesia~     (PCA). In contrast, Continuous infusion of intravenous morphine (CIVM) is seldom used in~     Post-Anesthesia Care Units (PACUs) for acute postoperative pain, due to concerns of~     cardio-respiratory deterioration, even though different studies have found this technique of~     administration effective and safe (in terms of opioid-related symptoms.As part of our efforts~     to improve postoperative pain management in the Tel Aviv Sourasky Medical Center's PACU, we~     wish to determine if combining CIVM with IV PCA will be superior over IV PCA only for the~     treatment of postoperative pain following major abdominal or thoracic surgery.Our hypothesis~     is that the continuous infusion, even if given at a relatively low dose, would enable the~     build-up of pharmacologically effective MO blood level, thus providing an overall better~     control of pain.~   "
207154|NCT00849706|"~     Long and unorthodox working hours (e.g. 24 hours or 23pm-07am shifts for doctors and nurses~     respectively) combined with sleep deprivation, may affect cognitive functions such as~     response time and concentration. These parameters may be tested using a driving simulator.~     Apart from the obvious consequences of driving skills impairment for the medical personal, it~     may serve as a quality assessment tool in evaluating the impact of workload and sleep~     deprivation on medical staff's function. This study aims to assess the effect of work load~     and sleep deprivation on medical staff's driving skills.~   "
207155|NCT00849693|"~     The purpose of this study is to assess whether duloxetine is superior to placebo in the~     treatment of children and adolescents with major depressive disorder (MDD)~   "
207156|NCT00849680|"~     The goal of this study is to understand the safety, tolerability and immunogenicity of the~     Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef~      Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo.~     The study will also evaluate a number of dose levels and the necessity for and timing of~     booster injections.~   "
207157|NCT00849667|"~     This research is being done to find out if Carboplatin and Taxane works better alone or when~     given with an experimental drug called MORAb-003(farletuzumab) in subjects with first~     platinum sensitive relapsed ovarian cancer.~   "
207158|NCT00849654|"~     The purpose of this study is to establish the safety and optimal dose of orally administered~     PCI-32765 in patients with recurrent B cell lymphoma.~   "
207159|NCT00849641|"~     Patients with decompensated liver cirrhosis exhibit numerous hemodynamic and microvascular~     changes, i.e., low systemic blood pressure and peripheral vasodilatation. In addition,~     alterations of tissue oxygenation are described in these patients.~      Near-infrared spectroscopy (NIRS) has been proposed as a tool to quantify microvascular~     dysfunction, for example in patients with sepsis (1) or after trauma (2). NIRS is a~     non-invasive technique that uses the differential absorption properties of oxygenated and~     desoxygenated hemoglobin to evaluate skeletal muscle oxygenation (3).~      Up to the investigators' knowledge no data exist on NIRS measurements in patients with~     decompensated liver cirrhosis.~      Aims of this study are to evaluate:~        -  Are there any changes in NIRS parameters in patients with decompensated liver cirrhosis~          in comparison to other critically ill patients (matched to SAPS II Score) or healthy~          individuals?~        -  Is there a correlation with common accepted prognostic scores (MELD Score or indocyanin~          green clearance) in decompensated liver cirrhosis patients and initial NIRS parameters?~        -  Does the NIRS trend within the first three days of ICU care in decompensated liver~          cirrhosis patients receiving fluid replacement therapy correlate with the course of~          disease?~             1. De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow~               is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul~               1;166(1):98-104.~             2. Creteur J. Muscle StO2 in critically ill patients. Curr Opin Crit Care. 2008~               Jun;14(3):361-6.~             3. Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent JL. The prognostic~               value of muscle StO2 in septic patients. Intensive Care Med. 2007~               Sep;33(9):1549-56.~   "
207160|NCT00849628|"~     The purpose of this study is to study factors (drugs, serum concentration of drugs,~     nutrition, physical activity, demographics, diseases etc.) related to constipation and~     diarrhea in nursing homes, and the effect of different laxative regimens.~   "
207161|NCT00849615|"~     Patients with locally advanced or metastatic gastric carcinoma or carcinoma of the~     esophagogastric junction without prior palliative therapy will be treated with 8 cycles of~     the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrollment a unique~     and detailed clinical evaluation of the dissemination of the disease will be done which~     includes a differentiated regard of the metastatic status. patients will be classified as~     having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic~     disease. In arms A and B surgical intervention is planned if operability is reached. The~     hypothesis is that by classifying patients more individually by the state of their disease,~     patients in arm B will have a significantly prolonged overall survival compared to patients~     in arm C.~   "
207162|NCT00849602|"~     The objective of this study was to evaluate the effect of chloroquine in the treatment of~     patients with dengue.~   "
207163|NCT00849589|"~     The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol~     that has demonstrated efficacy in reducing underage drinking among adolescent primary care~     patients and then to test it in a multi-site randomized controlled trial (RCT).~   "
207164|NCT00849576|"~     The purpose of this study is to compare the effects of insulin VIAject with Regular Human~     Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.~   "
207165|NCT00849563|"~     The primary objective of the study is to assess the clinical utility of a genetic test for~     Type 2 diabetes risk in combination with standardized risk assessment compared with~     standardized risk assessment alone, and to measure whether changes in perceived risk~     following genetic testing for Type 2 diabetes risk are correlated with behavior change and~     increased concern about risk for Type 2 diabetes.~   "
207166|NCT00849550|"~     The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard~     treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.~   "
207167|NCT00849537|"~     In this study, regressed proliferative diabetic retinopathy, very severe, severe and moderate~     non-prolifrative diabetic retinopathy patients who were going to have a cataract surgery,~     underwent a complete eye examination, OCT, FAG and color photography 2 weeks prior to their~     operation. All patients divided in two: 1) control group (Phyco,PCIOL), 2) triamcinolone~     treatment group (Phaco with PCIOL+IVT). One month after surgery a complete eye examination~     will be done especially; IOP and endophthalmitis. A 6 month follow-up will be done for these~     two groups and diabetic retinopathy progression will be checked.~   "
207173|NCT00849446|"~     Background:Accelerometry has only recently been introduced in clinical stroke research.~     However, whether accelerometry is a valid and reliable tool in stroke needs to be~     established. From literature becomes clear that existing accelerometers show shortages at~     patients with stroke because of the specific deficits that these patients have.~      Purpose: The aim of this study is to investigate the validity and test-retest reliability of~     the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke~     patients.~      Patients and Methods Subjects: Fifteen patients and fifteen healthy subjects will be included~     in the study following written informed consent. The following demographic and clinical data~     were recorded: age, gender, height, length, medication use, self-reported handedness,~     Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories,~     medical and surgical history.~      Methods: During one test session the subjects had to carry out an amount of activities~     according to a standardised protocol existing of lying down, sitting, standing, walking, step~     exercise and cycling. These activities are presenting activities of daily living.~      Measures:Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring~     devices will be compared with the data retrieved from 2 Yamax pedometers and the~     ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy~     expenditure, METabolic equivalent, time lying down.~   "
207174|NCT00849433|"~     Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory airway~     diseases affecting millions of people worldwide. Inhaled corticosteroids (ICS) are by far the~     most effective treatment with a broad anti-inflammatory spectrum. Nevertheless, most COPD~     patients and a proportion of severe asthma patients are corticosteroid-resistant (CR) and to~     fail to respond to ICS even when higher doses are given. These corticosteroid-resistant~     patients suffer from persistent symptoms and repeated asthma exacerbations. It has been~     suggested that smoking and oxidative stress may induce corticosteroid-resistance. The~     reactive oxygen species (ROS) responsible for oxidative stress can be generated exogenously~     (air pollutants, cigarette smoke) and endogenously by metabolic reactions. After inhaling air~     pollutants or cigarette smoke, the bronchial epithelium is exposed. Preliminary data from our~     own lab suggest that smoking and oxidative stress may decrease epithelial cell-cell contact~     formation. This results not only in a decreased barrier function, but also in an increased~     production of pro-inflammatory mediators.~   "
207175|NCT00849407|"~     Though it is generally accepted that exposure to sunlight is a major causative factor for~     skin cancer, the risk for developing melanoma is not directly linked to sun exposure such as~     in non-melanoma skin cancer. Therefore, a dual pathway has been proposed, distinguishing~     melanoma that develops on skin that is chronically exposed to sunlight from those that occur~     on skin that is normally protected. The risk for each type of melanoma is believed to be~     determined in part by genetic factors. To define these markers reproducibly, the~     investigators plan to establish a large cohort with comprehensive information regarding sun~     sensitivity (skin type), history of experienced sun exposure, skin pigmentation phenotypes,~     total number of nevi, and other types of skin tumors in a central European population. The~     investigators will obtain blood from all participants for DNA as well as serum analyses.~     Based on the finding that genetic variants of the melanocortin-1 receptor (MC1R) gene,~     associated with red hair and fair skin, have been shown to be associated with increased risk~     for melanoma, particularly those harboring BRAF mutations, the investigators will now focus~     on the study of recently discovered genetic variants associated with pigmentation.~     Furthermore, the investigators will study the relation of these variants with oncogenic~     mutations of melanoma in BRAF, RAS and c-Kit. The study of other genetic variants will~     follow, once a sufficiently large cohort has been established to reveal an independent~     genetic risk factor in a multivariate analysis including potential covariates as mentioned~     above. The identification of genetic risk factors for melanoma will not only help identify~     individuals with increased risk but also improve our understanding of the molecular~     background of the development of melanoma.~   "
207176|NCT00849394|"~     This is a clinical research study to look at the incidence of proteinuria (a condition in~     which urine contains an abnormal amount of protein) caused by shortened infusions (given into~     the vein over 10 or 15 minutes) of bevacizumab (a medication prescribed for colon, lung, or~     breast cancer). There are currently no published studies or clinical data looking at how safe~     shortened infusions of bevacizumab are in relationship to the side effect of proteinuria. We~     hypothesis that shortened infusions of bevacizumab will result in an increased risk for~     proteinuria compared to the standard infusions of this agent.~   "
207177|NCT00849381|"~     This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV~     vaccine GSK580299 in female subjects who took part in study 008/580299 and received the~     control vaccine (Hepatitis A vaccine).~   "
207178|NCT00849368|"~     Main Study Objectives:~      The study is conducted to~        -  evaluate the minimal allopurinol and azathioprine doses that, in combination, produce~          therapeutic 6-TGN levels~        -  evaluate the safety and tolerability of the different allopurinol/azathioprine dose~          levels~        -  assess if concomitant allopurinol affects TPMT activity~        -  assess the clinical efficacy of concomitant allopurinol-azathioprine therapy in the~          included patients~   "
207179|NCT00849355|"~     The purpose of this study is to evaluate the efficacy (and safety) of the following treatment~     squeme:Ciclophosphamide, Vincristine, lyposomal Doxorrubicine (Myocet) and~     Prednisone,combined with Rituximab in first line treatment for patients with aggresive No~     Hodgkin B lymphoma and cardiovascular risk~   "
207180|NCT00849342|"~     This study is conducted in Europe. The aim of this observational study is to investigate the~     effect of switch from other basal insulin treatments to Levemir® on body weight in obese~     diabetic patients. A local extension will be conducted in Slovenia in order to reach the~     planned 400 patients for the sub-analysis of Slovenian patients.~      Included in the study is a retrospective part to evaluate the weight progress since~     initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD)~     and/or bolus insulin therapy. Retrospective data will be collected at baseline and at~     approximately 6 and 12 months before starting insulin detemir therapy.~   "
207181|NCT00849329|"~     This study will characterize the effect of elevated gastric pH mediated by the proton-pump~     inhibitor, esomeprazole, on the relative bioavailability of lapatinib in subjects with~     metastatic ErbB2 positive breast cancer.~   "
207183|NCT00849303|"~     The purpose of the first part of this study is to understand plastic brain mechanisms~     associated with successful gait-oriented stroke rehabilitation. Patients are randomized to~     receive intensive in-patient multiprofessional rehabilitation at different time points. One~     group will receive rehabilitation immediately after an acute care at the neurological clinic~     (8 days) and one group 5 weeks after the insult. Patients practise walking every workday for~     60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive~     also other physiotherapy. In addition to selected parameters measuring brain plasticity,~     detailed assessments of functional abilities including motor ability and quality of life will~     be performed. A novel tool, MR-image navigated transcranial magnetic stimulation (TMS) is~     utilized in assessing cortical excitability in relation to stroke, time, rehabilitation, and~     recovery.~   "
207184|NCT00849290|"~     This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease~     progression on protocol D9902 part B (NCT00065442)~   "
207185|NCT00849277|"~     The purpose of this study is to determine whether probiotic treatment improves the protection~     against respiratory infections after influenza vaccination in elderly living in nursing~     homes.~   "
207186|NCT00849264|"~     This study is working to evaluate the surgical comprehensive treatment for different types of~     tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a~     standardized, unified, effective therapeutic program.~   "
207187|NCT00849251|"~     RATIONALE: Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride~     and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to~     the cancer. Giving pegylated liposomal doxorubicin hydrochloride together with bortezomib,~     cyclophosphamide, and dexamethasone may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving pegylated liposomal~     doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone and~     to see how well it works in treating patients with multiple myeloma~   "
207188|NCT00849238|"~     The rationale for this study is to determine if Campath-1H can be used in liver transplant~     recipients to induce a state of immunological unresponsiveness that would not only eliminate~     the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids~     utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the~     severity of histologic recurrence of certain autoimmune diseases responsible for causing~     liver failure. The investigator propose a randomized prospective open label trial in 50 liver~     transplant recipients who will received a calcineurin inhibitors free immunosuppressive~     protocol that consist of a single dose of Campath-1H as an induction therapy in association~     with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group~     will receive a standard immunosuppressive regimen, which consists of IV steroid induction~     therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no~     induction antibody therapy.~   "
207189|NCT00849212|"~     The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese~     patients with refractory partial seizures which are uncontrolled with other anti-epileptic~     drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per~     day). The dose of E2007 will be adjusted during 6 weeks. Subsequently, the dose will be fixed~     and maintained during 4 weeks.~   "
207190|NCT00849199|"~     The purpose of this study is to collect information from a large group of women who may have~     a greater chance to develop cancer because of their own personal history of cancer or because~     of their family history of cancer.~   "
207191|NCT00849186|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery~     and to see how well it works in treating patients with localized or metastatic kidney cancer.~   "
207192|NCT00849173|"~     Endometriosis, a condition in which the lining of the uterus grows on nearby tissues, is a~     common condition that affects women of reproductive age worldwide. The diagnosis of~     endometriosis is usually made at surgery. The most common symptom is pelvic pain. This pain~     may occur at the same time as menstrual bleeding, at other times of the cycle, or during or~     after sexual intercourse. Previous studies reveal the diagnosis of endometriosis is often~     delayed between 8 and 12 years after the first symptoms. Women with chronic pelvic pain~     report a lower quality of life. No studies, however, have been conducted to assess whether~     women with endometriosis-related pelvic pain are affected differently than those with pelvic~     pain from other or no identifiable causes.~      This large-scale study is designed to gather prospective epidemiological data on the impact~     of and risk factors for endometriosis across countries worldwide. A study of this scale and~     scope has never been performed; it is anticipated that the study will provide novel insights~     into the effects of the condition and associated symptoms on women s lives across different~     countries, as well as explore differences in the effects of various potential risk factors.~      This is an international study conducted at more than 20 sites worldwide and coordinated by~     Oxford University in the United Kingdom. At the National Institutes of Health, 250~     premenopausal women between 18 and 45 years of age who are having their first diagnostic~     laparoscopy or laparoscopy for tubal sterilization will participate. None will have had a~     prior diagnosis of endometriosis through surgery. Women will be informed about the study when~     their laparoscopy is scheduled.~      Procedures~        -  Patient completion of an online questionnaire before scheduled surgery. The following~          will be assessed by the questionnaire:~        -  Quality of life~        -  General gynecologic and medical history~        -  Family history~        -  General information~        -  Use of health care services~        -  Risk factors~        -  Surgeon completion of questionnaire about surgical findings.~        -  Follow-up: Women who consent will be contacted every 1 2 years.~   "
207193|NCT00849160|"~     Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to~     reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in~     vivo studies have shown that the induction of resistance mutations in the protease gene is~     much more difficult with the association darunavir/r compared to the other ritonavir-boosted~     protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to~     resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of~     this molecule allows a once daily administration with a 800/100 mg dose in patients infected~     with a wild HIV strain or with a slightly resistant to darunavir/r strain.~      Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a~     substitute to a protease inhibitor regimen administered twice daily in patients with~     undetectable viral load receiving a tritherapy including a protease inhibitor administered~     twice daily.~   "
212056|NCT00784706|"~     The purpose of the current study is to evaluate motor and neglect recovery of stroke patients~     produced by CIT using kinematic and oculomotor assessment, together with conventional~     clinical measures.~   "
207196|NCT00849121|"~     The investigators are trying to find new methods to treat prostate cancer. The approach is to~     try to enhance patients' own immune response against the cancer. In this study, the~     investigators will be testing the safety of a vaccine that may be able to help the body fight~     prostate cancer.~      The vaccine, called pTVG-HP, is a piece of DNA genetic material that contains genetic code~     for a protein that is made by the prostate gland, called prostatic acid phosphatase (PAP).~     The vaccine will be given together with a substance called an adjuvant. Adjuvants are~     typically given with vaccines and can improve the effect of the vaccine. The adjuvant that~     will be used in this study is called granulocyte-macrophage colony-stimulating factor~     (GM-CSF).~      The main purpose of this study is to find out whether the vaccine generates long-lived immune~     responses, and whether a better schedule of vaccination can be found by doing frequent~     laboratory testing for immune responses. The investigators also want to see if the vaccine~     stimulates any immune reaction against cancer cells.~   "
207197|NCT00849108|"~     The main purpose of this study is to get more information on using BMS747158 (the study~     drug),a drug with small amounts of radioactivity to allow for heart imaging, during a PET~     scan which can then be compared to other images such as SPECT. The safety and quality of~     images will be studied.~   "
207198|NCT00849095|"~     Study No.001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del~     FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether~     asthma not controlled by low doses inhaled corticosteroids, thus in need for step up therapy,~     can be equally controlled by guidelines recommended regular bid treatment with long acting~     beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an~     ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able~     to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol~     (experimental treatment) versus regular, twice daily 160/4.5 mcg inhaled~     budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended~     treatment).~   "
207199|NCT00849082|"~     RATIONALE: Radiation therapy uses high energy x rays to kill tumor cells. This may be an~     effective treatment for prostate cancer. Androgens can cause the growth of prostate cancer~     cells. Antihormone therapy, such as goserelin and cyproterone, may lessen the amount of~     androgens made by the body and reduces the amount of androgens available to the body. It is~     not yet know whether radiation therapy alone is more effective than radiation therapy given~     together with goserelin and cyproterone in treating patients with prostate cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared to giving radiation therapy together with goserelin and cyproterone in~     treating patients with prostate cancer that is at high risk for metastasis.~   "
207200|NCT00849069|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of~     GSK2231395A candidate vaccine in adults and elderly adults with chronic obstructive pulmonary~     disease. Subjects will be vaccinated 3 times with an interval of respectively 2 and 10~     months.~   "
207201|NCT00849056|"~     The purpose of this study is to determine the safety, tolerability and efficacy of~     albiglutide in the treatment of type 2 diabetes.~   "
207202|NCT00849043|"~     The purpose of this study is to evaluate the long-term durability of the treatment and safety~     of the Provent device for those individuals who were enrolled in the C009 study, were~     diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent~     device.~   "
207203|NCT00849030|"~     The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is~     beneficial in the treatment of breast cancer.~   "
207204|NCT00849017|"~     The purpose of this study is to determine whether albiglutide is effective in the treament of~     patients with type 2 diabetes.~   "
207205|NCT00849004|"~     Keloids and hypertrophic scars are not major illness. However, their effects can be from~     causing pain and itch which substantially interfere daily activity to as severe as causing~     deformity and other functional impairment. For standard surgical wounds, taking median~     sternotomy wounds from open heart surgery and lower abdominal wounds from gynecological~     wounds for example, the incidence of these problems can be from 10% to 60%. To prevent or~     treat these problems, physicians have used many modalities. One of the most convenient, most~     cost-effective and most non-invasive methods for patients is using dressings like silicone~     sheets, silicone gels or paper tapes, which is on the list of 1st line choices of an~     international recommendation. According to a literature review, most of the previous studies~     on similar topics are either of small sample size, on non-standard wounds or comparisons~     between wounds on different patient groups. The methodologies of previous studies are thus~     not vigorous enough. To get the highest level of evidence on selecting the best dressings for~     preventing and treating keloids and hypertrophic scars, we will recruit about 75 patients and~     apply two selected dressings on each halves of their standard surgical wounds to compare~     their differences. The investigators hope the result of this study can help us find the best~     modality to use and can contribute to the welfare of our future patients.~   "
207206|NCT00848991|"~     Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery,~     will improve patient management through the anesthesia postoperative recovery period~     determined by improvement in patients? tolerance of the endotracheal tube.~      Secondary hypothesis: The use of a Precedex infusion, in addition to propofol during surgery~     will provide improved hemodynamic stability.~   "
207207|NCT00848978|"~     The Health Enhancing Strength Training in Nonagenarians (STRONG) is a randomised control~     trial to assess the effectiveness of an aerobic and strength training program for improving~     functional capacity and quality of life in nonagenarians. Sixty (51 women) nonagenarians (age~     range: 90-102 years) who live in a geriatric nursing home will be randomly assigned to either~     a usual care (control) group (n=30) or an intervention (training) group (n=30). Participants~     allocated in the usual care group will receive general physical activity guidelines and~     participants allocated in the intervention group will also enroll in three weekly~     non-consecutive individualized training sessions (~45-50 min each) during 8 weeks. The~     exercise program will consist of muscular strength [with a special focus on leg press at 30%~     (start of the program) to 70% 1 repetition maximum (end)] and aerobic exercises~     (cycle-ergometry during 3-5 to 15 minutes at 12-14 points in the rate of perceived exertion~     scale). Results from STRONG will help to better understand the potential of regular physical~     activity for improving the well-being of the oldest population groups.~   "
207210|NCT00848939|"~     This study will assess the pharmacokinetic and safety profile of treprostinil following fixed~     and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study~     assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine~     SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of~     treprostinil diethanolamine SR up to a target dose of 4 mg BID.~   "
207211|NCT00848926|"~     This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the~     efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with~     relapsed or refractory Hodgkin lymphoma.~   "
207212|NCT00848913|"~     The purpose of this study is to examine the effect of progressive strength training of the~     fractured limb in patients with hip fracture, during admittance in an acute orthopedic ward.~     The primary study hypothesis is that the training will reduce the strength deficit in the~     fractured limb in comparison with the non-fractured limb. Secondary, that patients following~     the intervention will present larger improvements in physical function compared to controls.~   "
207213|NCT00848900|"~     The purpose of this study is to assess whether outdoor activities are effective in preventing~     the development and progression of juvenile-onset myopia in Chinese children.~   "
207214|NCT00848887|"~     This study will evaluate the safety and immunogenicity of different combinations of influenza~     vaccine in healthy young children.~   "
207215|NCT00848874|"~     Abstract: In Phase I, we designed and tested a Portable Visual Guidance System (PVGS), which~     combines a PDA - for user guidance - and an Internet website - for linking the user to an~     educational support team. Use of the PVGS 1) significantly improved the in vivo social~     pragmatics of students diagnosed with Aspergers Syndrome/Higher Functioning Autism (AS/HFA);~     2) revealed additional ways of improving social pragmatics; and 3) improved activity~     management in scheduling and vocational tasks.~      In Phase II, we will focus on social pragmatics and two closely related skills: feelings~     management and assignment management. We aim to:~        1. Replicate Phase I success in the most educational setting for AS/HFA high school aged~          students: mainstream school inclusion classes.~        2. Replicate Phase I findings more efficiently, with a less highly trained, on-site~          coaching staff and with more distant (non-site) expert supervision of that staff.~        3. Contrast the outcomes of the curriculum with a diagnosis-matched wait-list control~          group.~        4. Develop and implement software that will enable on-site staff to create and modify~          individualized guidance and monitoring screens as needs arise.~        5. Design a commercially attractive package of software, video training, video-conferenced~          support, and manuals.~        6. Complete the translation of the SymTrend website and all the above tools into Spanish.~      Significance: Successful completion of Phase II will:~        1. Provide a very effective and comprehensive system for teaching social pragmatics and~          related management skills to AS/HFA persons in an inclusion context.~        2. Provide a means of evaluating IEP effectiveness, thereby enabling a better use of~          special education funds and a reduction of litigation over IEP plan appropriateness and~          utility.~        3. Provide substantial support for our theoretical rationale for curriculum building in~          Special Education - a rationale that can guide the formulation of IEPs.~        4. Provide a theoretical rationale, an intervention framework, and intervention support~          technology that can be extended to cognitive behavioral treatment of other~          neuropsychiatric disorders and can be adapted for other forms of healthcare guidance.~        5. Provide an investigative system, as well as an intervention system, for tracking~          behavioral change in studies of frontal lobe and limbic neuroplasticity in~          neuropsychiatric disorders.~   "
207216|NCT00848861|"~     -to determine if propofol sedation leads to shorter recovery times compared to traditional~     sedation using midazolam plus meperidine~   "
207217|NCT00848848|"~     The study will evaluate the safety, tolerability and immunogenicity of different doses and~     types of Influenza Vaccine in healthy elderly subjects.~   "
207218|NCT00848835|"~     To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads~     over 5 years.~   "
207219|NCT00848822|"~     The purpose of this project is to look at how sleep affects glucose values in children with~     Type 1 Diabetes Mellitus. It will also evaluate if glucose is affected by times of day due to~     the body's own internal rhythm also known as the circadian rhythm.~   "
207220|NCT00848809|"~     This study is an observational analysis that monitors the effect of different dialysis~     methods on vancomycin levels when patients are critically ill. No changes are made to therapy~     based on levels, but levels are checked more frequently than normal. The primary dialysis~     methods being studied are SLED (slow-low efficiency daily) dialysis and intermittent~     hemodialysis. Vancomycin is the only medication being evaluated in this study. This study~     will provide detailed information on how to dose vancomycin in patients that are on dialysis~     in the intensive care unit.~   "
207221|NCT00848796|"~     Two heparin brands have been in the market in Canada for several years. Heparin Leo from Leo~     Pharma and Hepalean from Organon. The former is standardized by B.P (British pharmacopeia)~     while the latter is standardized by U.S.P (United states pharmacopeia). Previous studies have~     shown Heparin Leo to have roughly a 10% less efficacy then Hepalean. It has also been~     demonstrated that more protamine is required to reverse Heparin Leo. It is the investigators'~     intention to study the post-operative effects of the two brands of heparin and whether one of~     the two causes less bleeding after bypass surgery.~   "
207222|NCT00848783|"~     This study is to determine whether intraperitoneal (IP) Floxuridine is effective in the~     patients with advanced stomach or gastro-esophageal junction cancers in the treatment~     consisting of pre- and post-surgery chemotherapies.~   "
207223|NCT00848770|"~     This is a controlled clinical trial among non thrombolysed acute ischemic stroke patients to~     determine the effects of three levels of arterial pressure on death and neurological~     disability. After the admission in the vascular unit of the Emergency Department the patients~     are randomized to maintain during the first 24h the Systolic Arterial Pressure in tree levels~     of pressure: 140 to 160 mmHg; 161 to 180 mmHg and 181 to 200 mmHg. The end point of the study~     is the Modified Rankin score and mortality in three month after the discharge.~   "
207224|NCT00848757|"~     The purpose of this research collaboration between Dr. William Tamborlane, Deputy Directory~     of the Yale Center for Clinical Investigation (YCCI) and Fair Haven Community Health Center's~     (FHCHC) Diabetes Prevention Team is to determine the efficacy of an intensive life-style~     intervention (ILI) program that has been developed and implemented at the FHCHC to prevent~     the development of diabetes.~   "
207225|NCT00848744|"~     This study is a split face, paired-comparison, pilot study of at least 10 subjects to~     complete. Participants in this study will be patients seen at Children's Memorial Hospital,~     who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be~     recruited from one of the clinics, as well as from previous Institutional Review Board (IRB)~     approved acne studies housed in the Department of Dermatology. All subjects accrued from~     previous studies have agreed to be contacted for further investigations. Subjects 13 to 35~     years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of~     the face, and meeting inclusion criteria will be eligible to participate~   "
207226|NCT00848731|"~     This study will test the hypothesis that patients with acute PE and dyspnea can safely inhale~     NO. The secondary hypothesis is that patients who are blinded to the inhaled NO concentration~     will sustain subjective improvement in their perception of dyspnea based upon their reported~     Borg dyspnea score, during inhalation of NO.~      Specific aims~        1. Test if patients with acute PE and shortness of breath of severity ≥ 5 on a 0-10 scale~          called the Borg score can have inhaled nitric oxide administered via nasal cannula or~          face mask in a titration protocol that increases concentration by 5 ppm in 5 min steps~          to a maximum of 25 ppm.~        2. We will measure the number of patients who meet an absolute safety endpoint during~          titration. An absolute safety endpoint requires execution of a rapid weaning protocol (2~          ppm decrease per minute to 0 ppm).~           Absolute safety endpoints: Two consecutive SBP measurements more than one min apart with~          both readings < 80 mm Hg;SaO 2 <80% for more than 15 seconds; Patient deterioration as~          defined by: Clinical decision for need of inotropic or pressor support for any reason,~          seizure, new altered mental status, focal neurological signs suggestive of cerebral~          ischemia, evidence of myocardial ischemia, protracted vomiting.~        3. Test if the patient-reported Borg score decreases with administration of NO. Patients~          will not be told any details about the timing of the titration and will not be made~          aware of their iNO concentration when the Borg score is assessed.~   "
207227|NCT00848718|"~     The purpose of this study is to compare the safety and tolerability of several dose levels of~     MK-2206 in combination with chemotherapy and targeted therapy agents in participants with~     locally advanced or metastatic solid tumors.~   "
207228|NCT00848705|"~     The goals of this R21 exploratory pilot and feasibility study were to: 1) design an~     Internet-based self-management intervention for adolescents with type 1 diabetes; 2) test~     that intervention in a small randomized trial to establish technical feasibility,~     intervention acceptability, and competence in completing the necessary recruitment and~     research procedures. Although not powered to detect statistically significant changes,~     possible outcomes of this study include improvements in problem-solving, coping, and~     self-management behaviors.~   "
207229|NCT00848692|"~     Based on pilot patient observations,the investigators anticipate that chronic fatigue~     syndrome (CFS) patients may benefit from B-cell depletion therapy.~      The hypothesis is that at least a subset of CFS patients have an activated immune system~     involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.~   "
207230|NCT00848679|"~     The investigators previously demonstrated that epidural ropivacaine reduces uterine artery~     vascular resistance in a dose dependent manner in pre-eclampsia. The investigators also noted~     a marked right-left difference in vascular resistance between paired uterine arteries, which~     was almost completely abolished following epidural ropivacaine. However, this novel~     observation was not a stated outcome variable before the study began. This study assesses~     right-left difference in vascular resistance between paired uterine arteries as a primary~     end-point, assesses the dose-response effect of epidural lidocaine and compares the effect~     observed in pre-eclampsia with that in two control populations (term normal pregnancy and~     non-pregnant controls).~   "
207231|NCT00848666|"~     The purpose of this study is to evaluate the safety and efficacy of a novel topical therapy~     in patients with laboratory confirmed tinea pedis. During the follow-up period clinical and~     mycological examinations will be performed.~   "
207232|NCT00848653|"~     The ELECtrode configuraTION CRT Study (ELECTION)~   "
207233|NCT00848640|"~     The purpose study is to evaluate the efficacy and safety of Sorafenib as first line treatment~     for patients - unsuitable for another approved first line therapy - with advanced RCC in the~     Middle East Region.~   "
207234|NCT00848627|"~     In the study proposed, up to 1,500 men age 60 and over with strong smoking histories will~     test their urine for the presence of blood daily for two 10-day testing periods with the Ames~     Hemastix. Individuals with even a solitary positive test will undergo a thorough urologic~     evaluation to determine the cause of hematuria and follow-up will continue for 2 years after~     completion of the study.~   "
207235|NCT00848601|"~     Patients with hormone and docetaxel refractory prostate cancer or relapsed/refractory~     non-Hodgkin's lymphoma for which no available standard therapy or therapy which may provide~     clinical benefit is available will be enrolled. Primary objectives: estimate the maximum~     tolerated dose and dose-limiting toxicities. Secondary objectives: Response rate,~     pharmacokinetic and pharmacodynamic profiles, Prostate Specific Antigen response and renal~     elimination.~   "
207236|NCT00848588|"~     The overall goal of this pilot study is to design and conduct a survey of 9-1-1 call takers~     in the province of Ontario, Canada to better understand the factors associated with the~     successful identification of cardiac arrest (including victims with agonal breathing) over~     the phone. Specific objectives are:~        1. To conduct iterative semi-structured interviews to identify behavioural factors~          influencing identification of cardiac arrest by 9-1-1 call takers;~        2. To develop a survey instrument about behavioural factors influencing the ability of~          9-1-1 call takers to identify cardiac arrest based on a systematic review of the~          literature, the results of the semi-structured interviews, and theoretical constructs~          from the Theory of Planned Behaviour; and~        3. To conduct a survey among Ontario 9-1-1 call takers using the survey instrument, and to~          identify factors and strategies that might be targeted by Knowledge Translation~          interventions.~   "
207237|NCT00848575|"~     The culdoscopic approach will allow for equal or better visualization of female pelvic~     structures~   "
207238|NCT00848562|"~     Survival after invasive coronary revascularization is worse in patients with chronic kidney~     disease than in those without it. The investigators aimed to examine whether oral~     administration of nicorandil, a hybrid of nitrate and adenosine triphosphate-sensitive~     potassium channel opener, could improve the survival of end-stage renal disease patients with~     coronary artery disease by inhibiting cardiac death after coronary revascularization.~   "
207239|NCT00848549|"~     The purpose of this study is to assess the long-term safety and tolerability and to explore~     the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly~     diagnosed partial seizures.~   "
207240|NCT00848536|"~     A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to~     TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension~   "
207241|NCT00848523|"~     The drug LBH589 (panobinostat) is an experimental (investigational) drug that is being tested~     for recurrent (returning) malignant gliomas. An investigational drug is one that has not been~     approved by the U.S. Food and Drug Administration (FDA). It belongs to a new class of drugs~     called histone deacetylase inhibitors. Histones are proteins located in the nucleus of~     cells that bind to DNA, the chemical that makes up genes. These proteins help control which~     genes are turned on and off. Studies have shown that drugs like panobinostat (LBH589) may~     lead to tumor cell death.~   "
207242|NCT00848510|"~     This study is intended to test an experimental drug called EMD 525797 (Abituzumab). This drug~     is not yet approved for sale and has only been tested in a small number of people to date~     (prior to this study starting another research study was carried out involving 37 healthy~     volunteers receiving the study drug). Until more is known about this study drug, it can only~     be used in research studies.~      This research study is planned to answer important questions about how the study drug is~     tolerated and how it may work in subjects with ovarian and colorectal cancer which has spread~     to the liver (i.e. metastatic cancer). The Sponsor (Merck KGaA) of this study is developing~     the study drug.~   "
207243|NCT00848497|"~     The purpose of this study is to determine the effectiveness of testosterone replacement~     therapy (TRT) in men following surgery to remove the prostate in improving erectile function.~     Subjects will be randomized (like flipping a coin) to one of two groups. One group will~     receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other~     will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.~      Subjects will begin drug treatment 3 months after the initial screening visit and will take~     study drug for 3 months only. Participation will end at the end of the 6-month visit.~   "
207244|NCT00848484|"~     This study is to evaluate the safety and efficacy of the study drug compared to placebo in~     the treatment of cognitive impairment in men with schizophrenia.~   "
207245|NCT00848471|"~     Measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a~     meal (600kcal) to compare the results of the two calorimeters in standardized conditions for~     the validation of quark RMR versus Deltatrac II~   "
207246|NCT00848458|"~     The purpose of this prospective, randomized, controlled, single-blinded investigation is to~     study the efficacy, tolerability and safety of azelaic acid iontophoresis (AAI) versus~     topical treatment with azelaic acid cream in female patients with melasma.~   "
207247|NCT00848445|"~     To evaluate whether atrial fibrillation (AF) therapies in Guidant Pulsar Max II or Insignia~     Plus DR have an effect on the occurance of AF in patients with no prior history of AF~   "
207248|NCT00848432|"~     This study set out to determine the duration of maintenance treatment with therapeutic~     risperidone dose in schizophrenia. In a multi-center, open label, randomized, controlled~     study design, patients with schizophrenia who were clinically stabilized following an acute~     episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued~     for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks~     followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week~     group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for~     at least another 6 months).~   "
207249|NCT00848419|"~     The aims of this study are to provide pharmacokinetic-pharmacodynamic data to quantify the~     analgesic and side effect profiles of epidural methadone, fentanyl and morphine. The~     investigators will compare the analgesic effect at three dermatomes to assess the rostral~     spread of drug, the investigators will assess plasma levels to assess the systemic~     redistribution of drug and the investigators will assess surrogate markers of central opiate~     effects (nasal capnography and pupilometry). The investigators hypothesize that due to the~     long-duration of action of methadone, and its intermediate lipophilicity, that methadone will~     provide a predominantly segmental analgesia of long duration of action, with low rostral~     spread and low direct central depressant effects (including respiratory depression).~   "
207250|NCT00848406|"~     Smoking induces an inflammatory reaction in the airways which can ultimately result in~     persistent damage and the development of a Chronic Obstructive Pulmonary Disease (COPD).~     However, not all subjects who smoke end up with COPD. After long-term smoking, approximately~     20% of subjects develop COPD. At this time, it is unclear why some subjects develop COPD,~     whereas others maintain a normal lung function.~      In addition, smoking has important consequences in asthma. Patients with asthma who smoke~     have a more severe asthma and more often experience an asthma exacerbation. In addition, it~     has been shown that inhaled corticosteroids are less effective in smoking asthmatics.~      With this research project, the researchers will investigate the effects of smoking on the~     airways. To this end, the researchers will compare markers of airway inflammation, lung~     function and symptoms between healthy smokers and non-smokers of varying age. In addition,~     the researchers will compare those healthy subjects with patients with asthma and COPD which~     are characterized in earlier studies.~   "
207251|NCT00848393|"~     Cardiac surgery induces a measurable stress response in patients which leads to increased~     morbidity and mortality post-operatively. Through clinical observation, anesthesiologists~     have determined that varying the combinations of anesthesia drugs used during surgery and~     just after reduces the stress response, and by extension, morbidity and mortality. However,~     only a few studies have explored this phenomenon scientifically.~   "
207252|NCT00848380|"~     This practical experience should report a retrospective collection of data regarding~     cardiovascular risk factors of cardiovascular diseases. The goal is an evaluation of the~     development of the risk profile of cardiovascular patients with simultaneous treatment of~     hypertension and hyperlipidemia~   "
207253|NCT00848367|"~     The main objective of the proposed study is to determine whether the effectiveness of a group~     therapy treatment for Binge Eating Disorder (BED) is improved and attrition reduced by~     optimally matching women with BED who have high attachment anxiety to Group Psychodynamic~     Interpersonal Psychotherapy (GPIP). This study represents the next phase in a program of~     research stemming from a previously conducted randomized controlled trial (RCT).~   "
207567|NCT00844246|"~     The purpose of this study is to examine the feasibility, acceptability and effectiveness of~     implementing the American Academy of Pediatrics (AAP's) recommendation that clinicians~     provide developmental surveillance at all well child visits and institute developmental~     screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months~     of age.~   "
207254|NCT00848354|"~     The purpose of this 2 phased, open-label study is to compare the safety and efficacy of~     etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin~     American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a~     randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that~     allows the investigator to choose continuation with the phase I treatment or the addition,~     discontinuation or titration of other DMARD therapy already being utilized for the study.~   "
207255|NCT00848341|"~     To document practices in Canadian ICD implant centres around defibrillation therapy efficacy~     testing.~   "
207256|NCT00848328|"~     RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab,~     can block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Giving lenalidomide together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab~     works in treating patients with follicular or small lymphocytic non-Hodgkin lymphoma that has~     relapsed or not responded to treatment.~   "
207257|NCT00848315|"~     The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a~     culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance~     adherence to diabetes self-management behaviors and improve glycemic control among low-income~     Hispanic individuals with type 2 diabetes mellitus.~   "
207258|NCT00848302|"~     Up to 30 patients with lower extremity disease scheduled to undergo diagnostic angiography~     will undergo baseline bloodwork and IVUS (intravascular ultrasound), followed by dosing with~     L-arginine to assess changes in endothelial function.~   "
207259|NCT00848289|"~     This clinical research study will identify biologic and lifestyle factors which increase a~     person's risk of developing specific cancer. Researchers propose to conduct a case-control~     study examining interindividual differences in susceptibility to tobacco carcinogenesis as~     predictors of bladder cancer risk. We will measure susceptibility to tobacco carcinogenesis~     and this will include studies of the genetic modulation of carcinogen activation and~     detoxification and of chromosome sensitivity to tobacco mutagens.~   "
207260|NCT00848276|"~     This study measures a recently discovered protein named PCSK9 (Proprotein convertase~     subtilisin kexin 9) in blood to see if it is influenced by male and female sex hormones.~     PCSK9 has recently been shown to control cholesterol and triglyceride levels by diminishing~     the ability of liver cells to remove cholesterol from blood leading to high blood cholesterol~     levels.~      It was found in previous studies that there was a relationship between blood levels of PCSK9~     and cholesterol in men but not in women. This gender difference is a new finding and it~     raises the question of whether male and female hormones might influence PCSK9's role as a~     blood cholesterol regulator.~      The study requires a pre-treatment fasting blood sample and another sample 3 months after~     starting hormone therapy.~   "
207261|NCT00848263|"~     Fractures of the distal radius are one of the most common orthopaedic injuries and are~     associated with a high complication rate. There is a lack of clinical trials comparing the~     different treatment modalities of fractures of the distal radius. The purpose of this~     randomized trial is to assess differences in functional outcome, radiological results, and~     complication rate in patients 55 years and older with an unstable displaced fracture of the~     distal radius without articular involvement treated with a dorsal nail plate or a volar~     plate.~   "
207262|NCT00848250|"~     The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic,~     inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with~     congenital heart disease.~   "
207263|NCT00848237|"~     The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It~     provides a framework for treatment and follow-up of patients with Barrett's esophagus~     (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for~     participating physician investigators to collect outcomes data related to the use of the HALO~     Ablation Systems.~   "
207264|NCT00848224|"~     The overall goal of this study was to implement and evaluate the effects of a systems-based~     and pharmacist-mediated program designed to improve adherence for patients with known~     coronary heart disease (CHD) to lipid-lowering pharmacologic therapy and of their~     physicians/nurse practitioners to the National Cholesterol Education Program Guidelines.~   "
207265|NCT00848211|"~     This protocol represents the first in human study of TUTI-16, and is being conducted to~     establish the safety and human immunogenicity (anti-HIV-1 Tat titers) of subcutaneously~     administered TUTI-16. Activity of TUTI-16 will also be determined in minimizing HIV-1 viral~     loads and sustaining CD4+ T-cell levels.~   "
207266|NCT00848198|"~     This is a prospective, observational case series to determine the clinical utility of tear~     osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to~     establish referent values for objective tests of the disease.~   "
207267|NCT00848185|"~     Introduction OHSS still remains a complication of assisted reproduction treatments. hCG~     administration to trigger final oocyte maturation will release vascular mediators, being VEGF~     and other proteins such as VE-Cadherin or Angiopoietin- 2. It has been shown that replacing~     hCG by GnRH agonists will induce a very short endogenous LH peak, potent enough to induce~     final oocyte maturation but no OHSS will develop. The investigators examined VEGF,~     VE-Cadherin and Angiopoietin-2 modulation by hCG as well as GnRH agonists in oocyte donors~     undergoing controlled ovarian stimulation.~   "
207281|NCT00848003|"~     We believe a readily available drink containing a high dose of probiotics has the potential~     to improve compliance through many of these mechanisms. This product also has the potential~     to positively impact the health of children and adults around the world, as yogurt will~     likely be more appealing to both children and their parents for long term consumption than~     pharmaceutical-like preparations. In addition to the benefits associated with the consumption~     of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense~     food.~      More specifically, the rationale for this Phase I study is to determine safety of our drink~     and comply with the FDA's recommendations pertaining to an IND application, we will conduct a~     phase I safety study.~      We hypothesize that BB-12 is safe in healthy adults ages 18 and over.~   "
207268|NCT00848172|"~     Background:~        -  Essential tremor (ET) is a neurological disorder characterized by uncontrollable~          shaking. Several medications are used to treat ET; however, they are often only partly~          effective and can have side effects.~        -  Research studies have shown that octanol, a food additive similar to alcohol, can~          improve tremor in animals. Octanol is less likely to make people drunk than alcohol. Two~          earlier NIH studies found that one form of octanol, called 1-octanol, did improve tremor~          in some people and had few side effects.~        -  In the body, 1-octanol is converted to octanoic acid. Researchers are interested in~          finding out whether octanoic acid can help people with ET.~      Objectives:~        -  To find out if octanoic acid can improve hand tremor in people with essential tremor.~        -  To measure levels of octanoic acid in the blood after it is taken.~      Eligibility:~        -  Patients 21 years of age and older with ET, who are willing to abstain from alcohol,~          caffeine, and all medications as required by the study and who are willing and able to~          fast for up to 12 hours at a time.~        -  Participants may not be of Asian or Native American ancestry because of genetic~          susceptibilities to the intoxicating effects of the study drug.~      Design:~        -  This study requires a 3-day hospital admission as well as two outpatient visits.~        -  Visit 1 (outpatient): Screening visit and blood alcohol level test~        -  Medical history, physical and neurological examination, a blood test, and an~          electrocardiogram to measure heart function. Women who are able to get pregnant will~          have a urine pregnancy test.~        -  Patients will consume 1.5 ounces of alcohol per drink (up to three drinks at least 30~          minutes apart), and be tested to evaluate how the tremor responds. Researchers will draw~          blood to measure blood alcohol level about 1 hour after the first drink and closely~          monitor patients for signs of intoxication.~        -  Inpatient examination~        -  Preparation: Researchers will prepare a schedule to stop any tremor medications that~          patients might be on. Patients may not drink alcohol or eat or drink anything with~          caffeine, including chocolate, for at least 2 days before admission.~        -  Day 1: Vital signs, blood (and urine pregnancy) tests, and electrocardiogram. Patients~          will be asked to wear a tremor monitor, similar to a wristwatch. Patients will also have~          IV lines inserted for blood draws.~        -  Days 2 and 3: Randomized study medication (octanoic acid on one day, placebo on the~          other day). Patients will fast before taking the drug, but will be allowed to eat and~          drink after the tests are completed (around noon).~        -  Blood will be drawn before taking the study drug and again (a total of nine times) after~          taking the drug.~        -  Tremor will be measured during the study, before and after taking the drug.~        -  Visit 2 (outpatient): 4 to 7 days after discharge~        -  Blood test and an electrocardiogram, and a series of questionnaires regarding the study.~   "
207269|NCT00848159|"~     This study aimed to measure the degree of thoracic kyphosis in elderly women with those~     affected by osteoporosis in the spine, through photogrammetry computer and check the~     difference between the values obtained with the assumption of greater thoracic kyphosis in~     osteoporotic women.~   "
207270|NCT00848146|"~     Refinements in laparoscopic surgery, coupled with advancements in therapeutic flexible~     endoscopy, have set the stage for surgery to move to even less invasive techniques to treat~     conditions in the GI tract and peritoneal cavity. Natural orifice translumenal endoscopic~     surgery (NOTES) offers a means of reducing and ultimately eliminating the need for abdominal~     incisions to gain access to the peritoneal cavity. In NOTES, a flexible endoscope and~     accessory instruments are inserted through a natural body orifice and passed through the wall~     of an organ to reach the abdominal cavity. By reducing or eliminating the need for abdominal~     incisions, NOTES may provide a least invasive surgical option that can reduce pain, recovery~     time, complications, and systemic inflammatory response when compared to a laparoscopic~     surgical approach. In this study, we propose to use the NOTES technique to eliminate the need~     for a 1.5-2.5 cm umbilical incision.~      Hypothesis 1: We hypothesize that a combined endoscopic and laparoscopic approach will be~     able to eliminate a 1.5 to 2.5 cm infraumbilical incision when performing a laparoscopic~     cholecystectomy.~      Hypothesis 2: Closure of the gastrotomy will be facilitated with the Ethicon TAS system.~   "
207271|NCT00848133|"~     The purpose of this study was to compare the early clinical outcomes of minimally invasive~     bilateral subvastus and midvastus approaches for total knee arthroplasty.~   "
207272|NCT00848120|"~     This single arm, open label study will assess the safety and efficacy, with regard to~     reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to~     severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4~     weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the~     study may continue with their treatment together with tocilizumab.The anticipated time on~     study treatment is 3-12 months, and the target sample size is <100 individuals.~   "
207273|NCT00848107|"~     This open label extension trial will allow ongoing treatment of subjects who participated in~     the randomized controlled trials, and will provide long term information about the safety of~     treprostinil diethanolamine SR in subjects with SSc and digital ulcers.~   "
207274|NCT00848094|"~     The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of~     3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy~     (IMRT) for locally advanced hepatocellular carcinoma (HCC).~   "
207275|NCT00848081|"~     The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to~     men who are currently taking a medication called an alpha blocker for the treatment of benign~     prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that~     the bladder is not completely emptied after urination).~   "
207276|NCT00848068|"~     To evaluate the effects of FID 114657 on the tear film lipid layer thickness of patients with~     dry eye.~   "
207277|NCT00848055|"~     The general aim of the trial is to determine the safety, tolerability and pharmacologic~     profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously~     to patients with chronic plaque psoriasis~   "
207278|NCT00848042|"~     This is an open-label, multicenter, single-dose pilot study of AuroLase(TM) Therapy in the~     treatment of patients with refractory and/or recurrent tumors of the head and neck. Three (3)~     treatment groups of five (5) patients each will be enrolled and observed for six (6) months~     following treatment. Each group will receive a single dose of AuroShell(TM) particles~     followed by one or more interstitial illuminations with an 808nm laser. Particle dose and~     laser power may be increased in each dosing group.~   "
207279|NCT00848029|"~     The present study will evaluate the immunogenicity, safety and immunogenicity of two doses of~     monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a~     surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult Subjects.~   "
207280|NCT00848016|"~     This phase II trial is studying how well gossypol acetic acid works in treating patients with~     recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery.~     Drugs used in chemotherapy such as gossypol acetic acid, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~   "
207282|NCT00847990|"~     The purpose of this study is to determine if a laboratory test developed by the Sequenom~     Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can~     better identify pregnancies that have a child with a chromosome abnormality such as Down~     syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.~   "
212057|NCT00784693|"~     The purpose of this study is to determine whether tanezumab is effective and safe in the~     treatment of pain associated with endometriosis.~   "
207283|NCT00847977|"~     isotonic NaCl serum is the first intent solution for infusion during the initial phase of~     reanimation for an acute cranial traumatism.~      However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious~     for the future of this patient.~      Isofundine present all charateristics to be use in this indication: pharmacokinetic and~     pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose~     provision and no interaction with hemostasis.~   "
207284|NCT00847964|"~     This is a pilot study to evaluate the feasibility and safety of the Algisyl-LVR™ device. The~     purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular~     restoration in patients with dilated cardiomyopathy who are scheduled to undergo routine open~     heart surgery. Algisyl-LVR™ will be injected into the myocardium under direct visualization~     during the surgical procedure. This clinical evaluation is intended to provide the initial~     evidence of the safety and feasibility of the device as well as the procedure used to deploy~     the device. The results of the initial trial will also help to establish the utility of~     various assessments in evaluating and following the effects of the device.~   "
207285|NCT00847951|"~     The purpose of this study is to evaluate the effectiveness of renal ultrasound to check~     kidney perfusion in premature and/or very low birth weight babies.~   "
207286|NCT00847938|"~     Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to~     NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is~     monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a~     mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in~     clinical routine. Acceleromyography is the most currently monitoring available in daily~     practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is~     necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to~     perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG~     TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with~     neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes~     parasympathomimetic effects which has to be reversed with atropine. When neuromuscular~     blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the~     visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side~     effects expected. The goal of the study is to compare the delay between a light neuromuscular~     block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02,~     0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.~   "
207287|NCT00847925|"~     A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to~     investigate the clinical safety and toleration (including systemic pharmacokinetics), wound~     healing and antiscarring potential of two applications of intradermal RN1001 in healthy male~     subjects~   "
207288|NCT00847912|"~     The main purpose of this study is to see if 5-fluorouracil (5-FU) skin cream can prevent the~     growth of new skin cancers on the face and ears. The cost of trying to prevent skin cancer~     will be compared to the usual cost of treating skin cancer. Participants are being asked to~     be a part of this study because the participants have been treated for two or more skin~     cancers within the past five (5) years. At least one of these cancers occurred on the face or~     ears. Having had two or more skins cancers in the past 5 years makes it likely that~     participants will develop additional skin cancers in the future.~      Exposure to ultraviolet radiation from the sun or artificial sources such as tanning beds is~     a major cause of basal cell and squamous cell carcinoma of the skin. Using lotions, creams,~     or gels that contain sunscreens can help protect the skin from premature aging and damage~     that may lead to skin cancer.~      The 5-FU skin cream used in this study is FDA-approved to treat some types of skin cancers~     and spots that might become skin cancer. However, 5-FU skin cream has never been studied to~     see if it can prevent skin cancer. This drug is not approved by the FDA for how it will be~     used in this study.~      In this study, one half of the patients will use the 5-FU cream and the other half will use a~     skin cream that looks identical to the 5-FU cream but does not have 5-FU or any other active~     drug in it.~      Approximately twelve VA medical centers will work together in this study. About one thousand~     (1000) patients will be in this study. The study is sponsored by the U.S. Department of~     Veterans Affairs Cooperative Studies Program.~   "
207289|NCT00847899|"~     The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH~     enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with~     impaired glucose tolerance and mild to moderate hypertension.~   "
207290|NCT00847886|"~     The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX)~     pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in~     subjects with stable rheumatoid arthritis that are receiving stable doses of MTX.~   "
207291|NCT00847873|"~     Intimate partner violence is a significant societal problem. There is considerable evidence~     that a strong relationship between the use of alcohol and other drugs and intimate partner~     violence exists. Besides, a few studies indicate that reducing substance use may have a~     positive impact on IPV. Therefore, in this study, patients in substance abuse treatment for~     the use of alcohol, cannabis or cocaine who also admit to perpetrating intimate partner~     violence will be randomly assigned to either cognitive behavioral therapy addressing~     substance abuse combined with treatment for offenders of intimate partner violence or~     substance abuse treatment alone.~   "
207292|NCT00847860|"~     The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in~     prevention and treatment of vascular dementia, in those with brain white matter lesions and~     vascular risk factors.~   "
207293|NCT00847847|"~     Consistent data suggest that neuromuscular transmission is impaired in ALS patients.~     Neuromuscular junctions dysfunction may appear very early in the disease, as shown by data in~     animal models. The pathogenesis of this neuromuscular transmission impairment is unknown.~     Nogo A isoform, a possible marker of the disease over-expressed in skeletal muscle of ALS~     patients, can be involved. We will characterize the pathophysiological mechanisms implicated~     using a complete study of the structure and function of the NMJ on muscle biopsies, in a~     group of 20 ALS patients compared to 10 controls.~   "
207294|NCT00847834|"~     To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the~     treatment of patients with mild to moderate primary hypertension.~   "
207295|NCT00847821|"~     This study is an observational study analyzing the biopsy samples collected from subjects~     that participated in Study 3115A1-303 (NCT00675688). These endometrial biopsy samples will be~     de-identified at an anatomical laboratory and then sent to a molecular biology lab where an~     RNA extraction and analysis will be performed. The purpose of this study is to compare~     specific endometrial gene regulation at the level of mRNA expression in samples from placebo,~     bazedoxifene/conjugated estrogens, and raloxifene treated groups with a known set of genes~     that have been previously identified to be associated with estrogenization, endometrial~     hyperplasia, and endometrial cancer.~   "
207296|NCT00847808|"~     The purpose of this study is to determine if patients with well-controlled heartburn symptoms~     on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to~     once-daily (QD) dexlansoprazole modified release (MR) 30 mg.~   "
207297|NCT00847795|"~     An exploratory Phase-II trial with intradermal RN1001 (Avotermin) to investigate scar~     prevention and reduction and acceleration of healing. The trial has an additional objective~     to evaluate several different scar assessment techniques that can be used in future clinical~     trials in the prevention and reduction of scarring.~   "
207298|NCT00847782|"~     The purpose of this study is to validate novel assays for serum biomarkers of lipid~     metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers~     differ in subjects with normal or high cholesterol levels~   "
207299|NCT00847769|"~     The purpose of this study is to determine changes in the brain associated with improvement in~     ankle range of motion following ankle manual therapy procedures in individuals with~     post-acute ankle sprains~   "
207300|NCT00847756|"~     Otitis Media (OM) is one of the most frequent diseases in childhood and the primary reason~     for children to visit a physician. In many countries it is the most common reason to~     prescribe antibiotics leading to increased drug-resistance of the causative agents, or to~     undergo surgery. Costs for general health care are expanding, and are estimated to be 3-5~     billion dollar annually in the United States. Prevention is suspected to be an important~     solution to this problem.~      Although OM management has no universal standard yet, it may imply watchful waiting,~     antibiotic treatment, adenoidectomy, insertion of tympanostomy tubes and (future)~     vaccination. Approximately 80% of the acute otitis media (AOM) cases is self-limiting within~     2-14 days and also otitis media with effusion (OME) resolves spontaneously: 60% of newly~     detected OME resolves within 3 months. However, in a significant part of the OM population~     persistent or recurrent episodes of OM are responsible for a significant morbidity for both~     children and parents, despite variable treatment options.~      Through the set up of a new prospective cohort in a clinical setting, relevant patient~     characteristics, the role of bacterial and viral pathogens, the role of recurrent infection~     in relation to biofilm formation, and the host response at protein level will be studied in~     detail. This project is expected to increase the understanding of the underlying mechanisms~     of OM disease, which will support future treatment and prevention strategies. Better~     understanding in OM pathogenesis is warranted in order to develop these novel preventive~     strategies.~   "
207301|NCT00847743|"~     Oxidative stress has been linked to many diseases associated with aging, including coronary~     heart disease and Alzheimer's disease. Antioxidants and special proteins in the body work~     together to help prevent damage by free radicals. Some studies have indicated that as people~     age, they are less able to fight off oxidative stress and have increased levels of~     inflammation.~      Tart cherries are known to be rich in antioxidants and plant-nutrients. The product we are~     using in this study is an all-natural tart cherry juice, mixed with apple juice concentrate~     and containing no additives and no preservatives.~      We hope to learn whether antioxidant supplementation, such as tart cherry juice, can~     measurably decrease oxidative damage and inflammation associated with aging.~   "
207302|NCT00847730|"~     The study is aimed at evaluating the clinician's preceived ease of using the V.A.C. GranuForm~     bride dressing and the patients perceived level of comfort during the dressing wear.~   "
207303|NCT00847717|"~     The treatment of clinically N0 neck in malignancies of oral cavity is controversial. The~     options include the policy of wait and watch(close observation and follow-up), elective~     irradiation of the neck, elective surgery of the neck (neck dissection).~      In elective neck dissections, the procedures commonly performed are modified radical neck~     dissection-III (functional neck dissection) and selective (supraomohyoid) neck dissection~     depending on the site of the primary lesion within the oral cavity. There are no trials of~     IIb preserving neck dissection in cancers of the oral cavity.~   "
207304|NCT00847704|"~     This study investigates whether assisted movement with biofeedback and muscle vibration~     applied to the lower limb reduces impairment and improves gait.~   "
207305|NCT00847691|"~     The clinical and histological diagnosis of sarcomas is often very difficult. The~     identification of chromosomal and molecular anomalies, such as amplifications, deletions or~     fusion genes is a powerful help for establishing a correct diagnosis of sarcomas and their~     benign counterparts. However, the cost of the cytogenetic and molecular techniques for the~     detection of these alterations is often a limitation to their use. The aim of our study is to~     evaluate the direct cost of the molecular techniques in comparison to the cost that would be~     generated by an appropriate therapy and care management of the patient in case of an~     erroneous diagnosis.~   "
207306|NCT00847678|"~     This is a multicenter, randomized, efficacy and safety trial to evaluate Mycograb®. Subjects~     will be randomized to one of the 3 arms: 1/ Amphotericin B (0.7 mg/kg/d) plus 5-flucytosine~     (100 mg /kg/d); 2/ Amphotericin B plus Mycograb® (dosed 1 mg/kg via a central line or~     peripheral venous line twice daily for 7 consecutive days); 3/ Amphotericin B plus~     5-flucytosine plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line~     twice daily for 7 consecutive days). After 2 weeks, all patients will be switched to~     fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. The total duration of the study~     will be approximately 24 months~   "
207307|NCT00847665|"~     The purpose of this study is to compare a 2-hour versus every 4-hour turning regimen on the~     incidence of grade > II pressure ulcers (PU) in patients in ICU on mechanical ventilation ≥~     24h that use alternating-pressure air mattresses (APAMs).~   "
207568|NCT00844233|"~     The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the~     neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of~     resectable liver metastases from colorectal cancer.~   "
207308|NCT00847639|"~     This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to~     evaluate the safety and tolerability of maintenance lenalidomide after allogeneic~     hematopoietic stem cell transplantation (HCT).~      Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic HCT at a~     starting dose of 10mg PO once daily. Dose escalation and de-escalation will be performed~     depending on tolerability of lenalidomide. Dose range is 5mg every other day to 5 - 25 mg~     given daily on days 1-21 of a 28-day cycle for 12 cycles maximum or maximum of 12 months from~     first dose of study drug.~      Patients will be followed until 28 days from completing the 12th planned cycle of~     lenalidomide maintenance or 12 months from first dose of study drug, which ever comes first,~     (14 to 15 months after receiving the allograft) or discontinuation of study drug.~   "
207309|NCT00847626|"~     The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil~     combined with chlorthalidone, once daily (QD), in participants with moderate to severe~     hypertension.~   "
207310|NCT00847613|"~     This study is designed to provide safety and efficacy data to support the development of~     CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of~     methotrexate.~   "
207311|NCT00847600|"~     Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous~     system, and may be beneficial in the treatment of patients with schizophrenia. Our recent~     8-week, randomized, double-blind trial among patients with chronic schizophrenia and~     schizoaffective disorders, in which PREG versus placebo and DHEA have been added to~     conventional or atypical antipsychotics have yielded encouraging results with low-dose PREG~     (30 mg/day; ClinicalTrials.gov identifier NCT00140192; Ritsner et al., in press). The goal of~     the present study is to evaluate the potential role of PREG's augmentation compared to~     placebo in the treatment of young patients with newly diagnosed schizophrenia or~     schizophreniform or schizoaffective disorders.~      In a 8-week, randomized, double-blind placebo-controlled trial PREG (50 mg/day) or placebo~     capsules will be added to the stable ongoing antipsychotic treatment of 60 patients with~     recent-onset schizophrenia or schizophreniform or schizoaffective disorders. Participants~     will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of~     research instruments will be used for assessment of psychopathology, cognitive functions,~     side effects, general functioning and quality of life. In addition blood PREG levels will be~     monitored at baseline and during the study. The study is powered to detect moderate~     between-group effects on persistent positive, negative and cognitive symptoms.~   "
207312|NCT00847587|"~     A highly effective single rod contraceptive implant is now available for use in the US.~     Delays in the insertion of the device until later in the postpartum period may negatively~     impact initiation rates. The objective of this study is to compare outcomes of early~     postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing~     contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary~     outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of~     breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side~     effects, time to resume sexual intercourse after delivery, and incidence of missed routine~     postpartum follow-up. In addition, a subset of patients who randomize to early postpartum~     insertion will have expressed breastmilk ascertained for nutrient composition.~   "
207313|NCT00847574|"~     The WORLD study is a single-center, year-long randomized controlled trial in free-living~     women. Participants were randomly assigned to follow either a lower-fat (LF) diet or a~     moderate-fat (MF) diet for weight management in a parallel-arm design. The two phases of the~     study were a weight-loss phase (phase 1) and a weight-maintenance phase (phase 2) (Figure 1).~     During phase 1, months 1 through 4, participants consumed a hypo-caloric diet consistent with~     the 2005 Dietary Guidelines in the free-living environment. During phase 2, months 5 through~     12, participants shifted into weight maintenance. It was hypothesized that a weight-loss~     intervention at the extremes of dietary fat recommendations of the 2005 Dietary Guidelines~     would be equally effective for weight loss while achieving comparable nutrient adequacy.~     Also, Overall, the lower-fat and moderate-fat diets would both be nutritionally adequate,~     based on the Healthy Eating Index.~   "
207314|NCT00847561|"~     This study will test the effectiveness of a family-based, cognitive behavioral therapy~     (CBT)-based program for preventing anxiety disorders in at-risk children.~   "
207315|NCT00847548|"~     Intimate partner violence is a significant societal problem. However, treatment of IPV~     perpetrators is far from effective, which may be partly due to the fact that the role of~     substance abuse is not taken into account. There is considerable evidence that a strong~     relationship between the use of alcohol and other drugs and intimate partner violence exists.~     Besides, a few studies indicate that reducing substance use may have a positive impact on~     IPV. Therefore, in this study, perpetrators of intimate partner violence with substance use~     disorders enrolled in domestic violence treatment will be randomly assigned to either~     standard treatment for offenders of domestic violence or a combination of the latter~     treatment with cognitive-behavioral therapy addressing substance abuse (combined treatment).~   "
207316|NCT00847535|"~     This is a clinical investigation approved by US FDA and Canadian Health Authority to study~     the safety and potential effectiveness of the autologous muscle cells for the treatment of~     stress urinary incontinence.~   "
207331|NCT00847340|"~     HPV infection has been recognized as the most prevalent sexual transmitted infection~     worldwide. Burden of many HPV related diseases is well known particularly regarding the~     different associated cancers (cervical, anal, vaginal, vulvar, oro-pharyngeal) (3) ; however,~     there is much less available information on the general burden of genital warts, the~     associated HPV types, the costs of related medical treatments and the knowledge and~     perceptions towards the disease and its prevention.~      Objectives:~        1. To determine the HPV genotypes distribution in genital warts in the study population.~        2. To assess the knowledge about transmission & prevention of HPV infection related~          diseases~        3. To determine the direct medical costs of genital warts attention.~   "
207413|NCT00846261|"~     In this retrospective study, the investigators evaluated the clinical and functional results~     of infected nonunion of the long bone with soft-tissue defects treated simultaneously with~     Ilizarov technique combining open dressing change in 22 patients. The investigators wanted to~     find out whether that the internal bone transport with external fixator combining open~     dressing change is a valuable method to treatment for those patients with infected bone~     nonunion and poor condition of the soft tissue such as sinus, skin defect.~   "
207317|NCT00847522|"~     The purpose of this research study is to use two different drugs to find where melanoma might~     spread and to remove these tissues. We believe that tumor cells from the melanoma first move~     through the lymphatic system (a system of clear fluid that moves around the body and carries~     white blood cells, much like the blood system) to a lymph node in an orderly way. If we can~     identify the first lymph nodes to receive a tumor cell, this can be removed and examined. We~     currently use one drug, called technetium-99m sulfur colloid which can detect about 90% of~     the first lymph nodes that the tumor cells would move to. Technetium-99m is a radioactive~     compound and can be detected through the skin by a special instrument that reads~     radioactivity. As part of this research, we would like to use a second drug called~     fluorescein (Fluorescite®) to see if it will identify the same lymph nodes or additional~     ones and examine these. This drug is fluorescent and can be detected even through the skin~     using a blue light. This drug is approved by the Federal Drug Administration (FDA) to for~     injection in the vein as a diagnostic aid and has been safely used in people for many years.~     In this study, we will be injecting it under the skin, which is a different use from how it~     is currently approved by the FDA. In the past another drug has been used, called isosulfan~     blue (Lymphazurin®), but availability of this drug is currently limited, and it has higher~     risks associated with it.~      This study is being conducted by Dr. Robert Andtbacka, Dr. Dirk Noyes, Dr. James McGreevy and~     at University of Utah. This study is a Phase I/II and is done to find out if the drug can be~     used safely when given under the skin and if it will work for this purpose.~   "
207318|NCT00847509|"~     Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and~     neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen~     (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre~     therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT~     imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates~     for early assessment of tumor response to radiation or chemo-radiation combo.~   "
207319|NCT00847496|"~     • To determine if AWBAT, used in treating partial-thickness burns, would provide better~     healing, pain control, control of infection, shorter length of hospital stay, lower costs,~     and improved scarring and long term recovery when compared to Biobrane®.~   "
207320|NCT00847483|"~     Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost~   "
207321|NCT00847470|"~     The purpose of this study was to document the reasons for placing the first restoration~     (filling) on a previously un-restored surface in a permanent (adult) tooth.~   "
207322|NCT00847457|"~     This study will evaluate whether standardized aerobic exercise is an effective treatment for~     depression in adolescents.~   "
207323|NCT00847444|"~     This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III~     study comparing the disease free survival after randomisation in patients treated with 3~     cycles of Epirubicine-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles~     of Docetaxel(D)-chemotherapy, versus 6 cycles of Docetaxel- Cyclophosphamide~     (DC)-chemotherapy, and to compare the disease free survival in patients with BMI of 24 - 40~     kg/m² after randomisation with versus without the lifestyle intervention. Patients will be~     required to have histopathological proof of a HER2/neu negative tumor and: axillary lymph~     node metastases (pN1-3) or high risk node negative, defined as: 'pT ≥2 or histopathological~     grade 3, or age ≤35 or negative hormone receptor status, but are not allowed to have evidence~     of distant disease. Patients will have to be entered into the study no later than 6 weeks~     after complete resection of the primary tumor. No other antineoplastic treatment other than~     surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be~     allowed prior to study entry and during the course of the study.~   "
207324|NCT00847431|"~     The goal of this study is to determine the vulnerability of mood-related neurocircuitry in~     Parkinson Disease (PD) using deep brain stimulation of the subthalamic nucleus (STN DBS).~   "
207325|NCT00847418|"~     The purpose of this study is the determination of blood concentration and the effectiveness~     of esketamine after nasal application.~   "
207326|NCT00847405|"~     The objective of this study is to compare the rate and extent of absorption of sumatriptan~     from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex®~     100 mg Tablets under fasting conditions.~   "
207327|NCT00847392|"~     This is a randomized controlled trial evaluating the effectiveness of bedside volumetric~     bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to~     an emergency department with suspected urinary tract infection.~      Ultrasound prior to catheterization allows Emergency Physicians to determine if the urine~     volume of the bladder is sufficient for successful catheterization. Advance knowledge of~     insufficient urine allows the Emergency Physician to defer the procedure until success is~     likely.~   "
207328|NCT00847379|"~     Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It~     is caused by a mutation in the gene for dystrophin, a protein that is important for~     maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility~     that leads to weakness and loss of walking ability during childhood and teenage years. A~     specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of~     DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally~     delivered, investigational drug that has the potential to overcome the effects of the~     nonsense mutation. This study is a Phase 2b extension trial that will evaluate the long-term~     safety of ataluren (PTC124) in boys with nonsense mutation DMD/BMD, as determined by adverse~     events and laboratory abnormalities. The study will also assess changes in walking, muscle~     function, and other important clinical and laboratory measures.~   "
207329|NCT00847366|"~     This is an open label trial for patients currently enrolled in other perifosine trials.~   "
207330|NCT00847353|"~     The main objective of this study is to investigate depolarization characteristics represented~     by changes in HyperQ in asymptomatic, apparently healthy athletic and non-athletic~     individuals. We also aim to examine a subgroup of obese and non-obese subjects. The goal of~     the study is to establish normal HyperQ values in these populations and compare HyperQ values~     of age-matched athletic vs. non-athletic individuals of similar health status.~   "
213242|NCT00768833|"~     The purpose of this study is to assess the prevalence of pneumococcal stereotypes in the~     nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at~     different ages over time.~   "
207332|NCT00847327|"~     Type 1 diabetes is a lifelong metabolic disorder that affects 1 out of every 400-600 American~     children each year, with many children being diagnosed at younger and younger ages.~      To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a~     physician-prescribed diabetes self-care regimen. As such, parents of children with Type 1~     diabetes must be highly involved in managing their child's disease on a daily basis,~     especially parents of affected children who are very young and more highly dependent upon~     parental caretaking.~      As children diagnosed with Type 1 diabetes at a very young age may be at an increased risk~     for the development of long-term behavioral and medical complications, more research is~     needed to understand and treat the leading contributors to diabetes-related parental distress~     and medical outcomes among this growing subgroup.~      Recent findings indicate that responsibility for diabetes management falls heavily on~     mothers. The majority of families do not receive outside child care assistance and report~     feeling overwhelmed. Parents report high levels of pediatric parenting stress difficulty, as~     well as moderate symptoms of anxiety. The current study aims to expand such preliminary~     findings and specifically examine the effects of a newly-developed parenting support program~     for parents of young children with Type 1 diabetes. The utility of the intervention will be~     evaluated. It is hypothesized that parents completing the parent support program will report~     lower levels of psychosocial distress and improved quality of life. It is hypothesized that~     the children of participating parents will also demonstrate improved quality of life and~     metabolic control.~   "
207333|NCT00847314|"~     With advancing age testosterone levels decline in men. Low testosterone levels plus certain~     symptoms are called Late Onset Hypogonadism (LOH). Adipose tissue may contribute to~     testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease~     in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH.~     Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement~     (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the~     additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist~     circumference) in patients, who are on a diet and exercise program.~   "
207334|NCT00847301|"~     An observational cohort study on safety and efficacy to generate additional data on the~     benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment~   "
207335|NCT00847288|"~     Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized,~     multi-center, post-market clinical trial in the United States. The purpose of this clinical~     trial is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol~     for initiation of clinical action. It is hypothesized that monthly review of Cardiac Compass~     Trends with OptiVol will shorten time to clinical action as compared to quarterly review.~   "
207336|NCT00847275|"~     The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly~     patients aged over 75 years with renal insufficiency stage 5 will be included in the study~     after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in~     the exclusive nephrology follow-up arm will continue their usual follow-up; 250 patients in~     the geriatric follow-up arm will have both their usual nephrology follow-up and a geriatric~     follow-up.The aim of the study is to determine if a systematized gerontologist evaluation~     delay the occurrence of a composite primary endpoint : death, dementia, depression and severe~     dependency. The hypothesis is that the functional and vital prognosis of a patient with renal~     insufficiency depends not only on common and classical factors but also on cognitive and~     psychological functions and dependence, particularly in elderly patients.~   "
207337|NCT00847262|"~     Recent studies have shown that obese people are more prone to high blood pressure. With the~     co-existence of obesity, hypertension and diabetes, patients were more susceptible to~     hyperlipidemia, coronary and cerebral atherosclerosis and peripheral vascular disease.~     Abdominal obesity has often accompanied by substantial accumulation of visceral fat, which~     increased secretion of many inflammatory mediators, cytokines and adipocytokines and played~     an important role in cardiovascular and metabolic disease. Some reports had shown that~     angiotensin II receptor blockers (ARB) may improve metabolic profiles in patients with~     diabetes or metabolic syndrome, in addition to its hypotensive effect. It has been reported~     that some ARB, such as telmisartan and candesartan, can prevent weight gain and~     high-fat-induced obesity in experimental animals. However, whether telmisartan intervention~     on improvement of fat deposition and other related metabolic profiles is better than a CCB~     drugs (amlodipine) in those obese hypertensive patients with diabetes, was still unknown.~   "
207338|NCT00847249|"~     The aims of the study are to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male~     subjects.~   "
207339|NCT00847236|"~     The aim of this study is to evaluate a simple and rapid method in order to better define and~     treat Polymyalgia Rheumatica by measuring levels of muscle achiness and pain with a blood~     pressure cuff.~   "
207340|NCT00847223|"~     To determine the EFFICACY and the SAFETY PROFILE and TOXICITY of Zarnestra® in the treatment~     of patients with previously treated mantle cell lymphoma not appropriate for autologous bone~     marrow transplantation. 27 evaluable subjects will be enrolled for an analysis in 2 stages~     (11 for the first stage, 16 for the second).~      Patients who receive at least one dose of Zarnestra® and have at least one post-baseline~     response assessment of discontinued study frug for early progression are evaluable. Subjects~     not evaluable for response will be replaced, up to 35 patients.~   "
207341|NCT00847210|"~     The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole~     modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with~     Symptomatic Gastroesophageal Reflux Disease.~   "
207342|NCT00847197|"~     This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared~     to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying~     therapy.~   "
207343|NCT00847184|"~     Time, success rate, and number of optimising maneuvers for tracheal intubation via the nasal~     approach are not different when Aitraq technique is used compared to a standard MacIntosh~     blade.~   "
207359|NCT00846976|"~     This is an open label, single-centered treatment protocol designed to monitor the safety of~     patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as~     physician feels that he is benefiting from this form of therapy.~   "
207344|NCT00847171|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Vaccines made from gene-modified tumor cells may~     help the body build an immune response to kill tumor cells. Giving trastuzumab together with~     cyclophosphamide and vaccine therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving trastuzumab together with~     cyclophosphamide and vaccine therapy in treating patients with high-risk or metastatic breast~     cancer.~   "
207345|NCT00847158|"~     This was a prospective, double-masked, 15-month clinical trial comparing efficacy of~     phacoemulsification alone to combined phacoemulsification and implantation of the iStent®~     trabecular micro-bypass stent in patients with primary open-angle glaucoma.~   "
207346|NCT00847145|"~     The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and~     Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster~     at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers~   "
207347|NCT00847132|"~     Depression in cardiac patients is common, persistent, and deadly. However, the vast majority~     of cardiac patients with depression go unrecognized and untreated, despite the existence of~     treatments that clearly improve depressive symptoms and may favorably impact survival. Our~     research group and others have found that depression recognition and treatment appears~     particularly limited among patients with acute cardiac illness, though this population may be~     the most vulnerable to the deleterious effects of depression. We propose a project, building~     on successful collaborative care depression management programs in outpatient settings, to~     address this important issue.~      The specific hypotheses behind the proposed research are that a collaborative care depression~     management program can be successfully adapted to inpatient cardiac units, and that such a~     program will lead to greater rates of adequate depression treatment and improvements in~     secondary outcomes.~      The following specific aims capture the stepwise goals of this program:~        1. To determine whether a collaborative care depression management program ('Enhanced~          Care') leads to significantly increased rates of adequate depression treatment compared~          to usual care (screening and feedback) (Primary Aim).~        2. To assess whether this Enhanced Care program has a lasting impact on adequate depression~          treatment, depressive symptoms, health-related quality of life, and adherence to medical~          recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care.~   "
207348|NCT00847119|"~     The project objective is to evaluate the efficacy of the neoadjuvant treatment with~     bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable~     locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and~     without distant metastases.~   "
207349|NCT00847106|"~     Dendritic cells (DC) are the professional antigen presenting cells of the immune system.~     Multiple distinct DC lineage's exist and it is now well appreciated that the DC subset and~     the maturation stage of the DC determines the type of immune response, ranging from a TH1 or~     TH2 response to immune tolerance. The extremely potent capacity of mature DC to initiate~     immune responses can be exploited to fight infectious diseases and cancer. Others and we are~     currently using tumor antigen loaded mature DC in clinical vaccination studies against~     cancer, and clinical as well as immunological responses have been observed.~      Exciting new insights accompany the revival of suppressor T cells, now referred to as~     regulatory T cells (Treg), and implicate that also Treg play a key role in the control of~     immunity. Treg constitute a sub-population of CD4+ T cells constitutively expressing the~     IL-2R alpha-chain (CD25). Treg show remarkably suppressive activities on different components~     of the immune system, including T lymphocytes and dendritic cells, suggesting they act both~     at the initiation phase (DC) and at the effector phase (activated T cells) of the immune~     response. Interestingly, temporal depletion of Treg has been shown to enhance anti-tumor~     immune responses and in case of prolonged absence of Treg even autoimmunity. Furthermore,~     data in mouse tumor models indicate that temporal depletion of Treg also results in improved~     vaccine efficiency in the therapeutic setting, e.g. in mice with a pre-existing tumor. These~     data imply that in tumor bearing patients depletion of Treg prior to vaccination will improve~     vaccine efficacy.~      In this study we investigate the effect of regulatory T cell (Treg) depletion on the efficacy~     of DC-based anti-tumor vaccines in a clinical study using melanoma associated antigens~     tyrosinase and gp100-loaded DC and a depleting anti-CD25 mononuclear antibody (Daclizumab).~     Our primary objective in this study is the induction of an effective anti-tumor immune~     response. Our secondary objective is the induction of a clinical response.~   "
207350|NCT00847093|"~     After surgery on his penis, your child will probably have some pain. The investigators will~     give you a prescription for acetaminophen (Tylenol) with codeine, given by mouth (orally),~     for pain. In this study, the investigators want to see if a local anesthetic cream applied to~     the base of the shaft of the penis can reduce the need for oral medicine .~   "
207351|NCT00847080|"~     The purpose of this study is to determine whether sitagliptin is effective in the treatment~     of reactive hypoglycemia by dysinsulinism.~   "
207352|NCT00847067|"~     The purpose of this study is to learn if paravertebral block (PVB) will reduce chronic pain~     after surgery. Our hypothesis is that chronic pain from breast surgery as a consequence of~     central sensitization can be prevented by blocking sensory input to the CNS during surgery~     and the immediate post-operative period.~   "
207353|NCT00847054|"~     The purpose of this study is to determine the safety of multiple intravenous infusions of~     MORAb-004.~   "
207354|NCT00847041|"~     The purpose of this study is to compare the bacteria, fungi, and viruses that are present in~     the sinuses of patients with chronic rhinosinusitis to patients without sinus disease using a~     new technology, called a microarray, that will allow more accurate identification of~     microorganisms than current laboratory methods.~   "
207355|NCT00847028|"~     This study investigates which concentration of glucose is most effective in reducing pain for~     venipuncture in the newborn.~   "
207356|NCT00847015|"~     The purpose of this study is to find out if using the combination of standard chemotherapy~     (gemcitabine and cisplatin) plus this new targeted pill (sunitinib) can help shrink your~     tumor before you undergo surgery for your bladder cancer.~   "
207357|NCT00847002|"~     This is a study to compare the healing process of venous stasis ulcers when the Flexitouch®~     system is added to the standard treatment of venous ulcers. We hypothesize that adding the~     Flexitouch® system to standard venous ulcer treatment will result in~        1. greater complete healing~        2. greater percentage reduction in ulcer area~        3. reduced time to complete healing, as compared to the use of standard treatment alone~        4. a greater reduction in affected leg volume as compared to standard treatment alone.~   "
207358|NCT00846989|"~     This purpose of this study is to access the efficacy, tolerability and safety of RKI983~     (0.05% and 0.10%) ophthalmic solution bid versus once daily latanoprost 0.005%, in patients~     with POAG or ocular hypertension.~   "
207362|NCT00846937|"~     We aim to examine efficacy of a plant stanolester beverage to lower serum cholesterol and~     LDL-cholesterol levels, when given with or without a fatty acid preparation. Study subjects~     are otherwise healthy proctocolectomized ileostoma patients (n=10), who consume stanolester~     beverage with or without a fatty acid preparation in a random order for one week period after~     a standardized low-fat meal. Washout period is 4 weeks. Serum lipids, lipoprotein lipids,~     sterols and fecal sterols and variables of cholesterol metabolism will be examined~     accordingly.~   "
207363|NCT00846924|"~     Atrial fibrillation is the most common cardiac cause of ischemic stroke. Detecting atrial~     fibrillation after a stroke or TIA is critical because highly effective secondary stroke~     prevention therapy is available for individuals who are recognized to have atrial~     fibrillation. However, atrial fibrillation is likely under-diagnosed after stroke and TIA~     because atrial fibrillation is often difficult to detect as it is frequently paroxysmal and~     asymptomatic, and patients do not routinely undergo prolonged screening. The purpose of this~     study is to determine the diagnostic yield of a novel 30-day cardiac event monitor compared~     to a repeat 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in~     patients with a recent ischemic stroke or TIA of undetermined etiology after completion of a~     standard clinical stroke work-up (including an initial negative Holter monitor.)~   "
207364|NCT00846911|"~     The objective of this global non-interventional study is to evaluate the impact of Acute~     Exacerbation of Chronic Bronchitis(AECB) on the patient and the community as well as the~     safety and effect of a treatment with Moxifloxacin tablets in daily life clinical practice.~     This includes data on the course of symptom relief, speed of return to normal daily life~     activities as well as records on adverse events.~      This study will be performed in accordance with international guidelines like EMEA (EMEA,~     EUDRALEX Volume 9A, Pharmacovigilance for Medicinal Products for Human Use) as well as local~     laws.~   "
207365|NCT00846898|"~     The aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon~     cassia) has the potential to improve HbA1c, blood pressure and serum lipid measurements in~     patients with type 2 diabetes mellitus.~   "
207366|NCT00846885|"~     The objective of this study is to compare the rate and extent of absorption of sumatriptan~     from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex®~     100 mg Tablets under fed conditions.~   "
207367|NCT00846872|"~     The hypothesis is that GHRP-3 will exert beneficial effects on endothelial function and~     insulin resistance in older men and women via hormonal (GH, IGF-I, IGFBP-3,-1, insulin) and~     non-hormonal actions (anti-inflammatory).~   "
207368|NCT00846859|"~     The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a~     prescription medication for smoking cessation (European trade name: Champix(R); US trade~     name: Chantix(R)), can reduce alcohol consumption in alcohol dependent individuals.~   "
207369|NCT00846846|"~     In order to expand safety information in patients treated with the Endeavor Drug Eluting~     Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT~     Trial. The amended study is PROTECT CONTINUED ACCESS (PROTECT CA).~   "
207370|NCT00846833|"~     We hypothesized that haploidentical NK cells kill tumor cells more efficiently than~     autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study~     to investigate the role of haploidentical NK cell therapy in patients with refractory or~     relapsed malignant melanoma.~   "
207371|NCT00846807|"~     An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate~     additional data in predefined sub populations of patients at increased risk of bleeding or~     VTE~   "
207372|NCT00846794|"~     This research is designed to study the reliability of the results of an AcuGraph in college~     students and faculty members with reported digestive symptoms~   "
207373|NCT00846781|"~     The purpose of this study is to obtain data on the potential of long-term treatment with~     denufosol to improve the clinical course of CF lung disease in patients with mildly impaired~     lung function and to provide CF patients who completed study 08-110 continued access to~     denufosol.~   "
207374|NCT00846768|"~     The primary objective of the trial is to determine the effect of BI 17444Cl on the lung~     function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients~     with chronic obstructive pulmonary disease. In the trial four treatments of each 3 weeks of~     duration are included: 2 dosages in a once daily administration and 2 dosages for~     administration twice daily.~   "
207375|NCT00846755|"~     The purpose of this study is to determine whether treatment of thyroid disease during~     pregnancy decrease the incidence of adverse outcome, and to compare the impact of Universal~     Screening versus case Finding strategy in detecting thyroid dysfunction~   "
207376|NCT00846742|"~     This phase II trial is studying how well combination chemotherapy with or without radiation~     therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in~     chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride,~     vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy~     uses high-energy x-rays to kill cancer cells for those patients that still had residual~     cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may~     kill more cancer cells and allow doctors to save the part of the body where the cancer~     started.~   "
207377|NCT00846729|"~     It is our purpose in this study to compare the kidney structure and function of older~     patients to that of young patients before and after removal of a single kidney for transplant~     donation and to examine the remaining kidney's ability to adapt and maintain function over~     time. More specifically, we aim to examine the effect of uninephrectomy on adaptive~     hyperfiltration in the remaining kidney. A secondary aim is to investigate whether subjects~     in the aging population undergo compensation to the same extent as younger subjects. We will~     also examine the compensatory rise in GFR (glomerular filtration rate) that follows~     uninephrectomy in both groups, and, again, compare the results in the aged versus young~     subjects. This will help in delineating the extent to which the aging population can be a~     potential source of living kidney donors for kidney transplantation.~      It is also our purpose with this study to refine the tests to be used in the donor evaluation~     process so as to accurately identify ideal candidates for safe kidney donation.~   "
207379|NCT00846703|"~     The Guangdong work group of childhood acute lymphoblastic leukemia (ALL) therapy was set up~     in October 2002. The investigators treated the childhood ALL with a GZ2002 protocol since the~     year 2002, and the protocol was mainly derived from the ALLIC-BFM 2002 protocol. After~     summarizing the last six years' experience, our group revised the GZ2002 ALL protocol in the~     year 2008, which is named GD-2008 ALL protocol. The diagnosis and classified criteria is~     according to the ALLIC-BFM 2002 protocol, and the chemotherapy protocol consists all the~     therapeutic phases as the ALLIC-BFM 2002 protocol prescribed.~   "
207380|NCT00846690|"~     The project is a study comparing the effectiveness of two topical anesthetics for control of~     pain associated with dental needle insertion in the palatal mucosa. A standard dental topical~     anesthetic (20% benzocaine) will serve as an active control and will be compared to a~     combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2%~     phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).~   "
207381|NCT00846677|"~     Vitamin D supplementation (400 IU/d) is recommended for all breastfed infants in Canada. Such~     recommendation is grounded in the fact that the prevalence of rickets in Canada is higher~     than desirable, likely due to low maternal-fetal transfer and low intakes postpartum.~      There is little data about adherence to supplementation in Canada, but one study shows that~     in primiparous mothers (n=1937) in Quebec, 58.1 % of those exclusively breast-feeding gave~     their infant vitamin D supplements in the first six months and 62.1 % of those feeding~     formula did not. For the Canadian situation, it is not clear if the modality of the~     supplementation is a barrier to providing the supplement. Thus the overall aim of this study~     is to test a new delivery system for parental preference and infant acceptance compared to a~     standard vitamin D supplement.~   "
207382|NCT00846664|"~     Patients will be performing Logan short arc banding protocols to see the effect on multifidus~     size~   "
207383|NCT00846651|"~     The purpose of this study is to compare two methods for preventing low blood pressure~     associated with spinal anesthesia during Cesarean sections.~   "
207384|NCT00846638|"~     The purpose of this randomized trial is to test the effectiveness of screening and brief~     intervention for risk drinking by nonpregnant women with specific medical problems~     exacerbated by excessive alcohol consumption. The medical problems are female factor~     infertility, hypertension, diabetes, and osteoporosis, conditions that are costly to treat~     and difficult to manage. Just as pregnant women are thought to be highly motivated to modify~     their alcohol consumption, so women with specific medical problems worsened by alcohol intake~     are an appropriate group to receive a brief intervention.~   "
207385|NCT00846625|"~     This is a pilot study to investigate the safety and efficacy of intravitreally administered~     ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due~     to chronic non-infectious uveitis. There is currently no FDA-approved therapy for this~     condition, however intravitreal injection of corticosteroids, in conjunction with oral~     steroids and/or immunomodulatory drug agents, has become the mainstay of therapy. Ranibizumab~     is a recombinant monoclonal antibody antigen-binding fragment that neutralizes the active~     forms of vascular endothelial growth factor (VEGF), which is believed to contribute to the~     etiology of inflammation and neovascularization. Ranibizumab is FDA-approved for the~     treatment of neovascular age-related macular degeneration.~   "
207386|NCT00846612|"~     This study is to study pharmacokinetics of Doxil using Doxil and Avastin on ovarian cancer~     patients who are resistant to or have relapsed from platinum-based therapy.~   "
207387|NCT00846599|"~     The purpose of this study is to examine the postprandial (anytime after a meal) effect of~     different dietary fats on endothelial function in HIV-infected and HIV-uninfected men.~   "
207388|NCT00846586|"~     This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when~     combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients~     with chronic obstructive pulmonary disease (COPD)~   "
207389|NCT00846573|"~     The purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR~     imaging in COPD, asthmatics, CF and healthy volunteers.~   "
207390|NCT00846560|"~     The involvement of Lymphocyte type B in Amyotrophic lateral sclerosis (ALS) patients will be~     compared to lymphocyte in healthy subjects.~   "
207391|NCT00846547|"~     The study objective is to explore the safety and tolerability of STX209 in subjects with~     Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in~     treating irritability. We hypothesize that STX209 will be safe and well-tolerated.~   "
207392|NCT00846534|"~     The purpose of the investigators study is to investigate the correlation between naturally~     occurring chemicals, called reactive oxygen species (ROS), in the blood of human patients and~     the development of an abnormal heart rhythm, known as atrial fibrillation (AF). The~     development of atrial fibrillation is associated with increased medical problems like stroke.~     Many factors seem to cause the development of AF, and this rhythm occurs frequently after~     open heart surgery. When patients develop AF after cardiac surgery they are at increased risk~     for cognitive changes, infections, the development of kidney failure, and increased length of~     hospitalization. ROS are chemicals in blood and tissues that tend to cause microscopic blood~     vessel and heart damage. These chemicals occur naturally as the result of chemical reactions~     that occur in states of stress and inflammation, like tissue trauma and as the result of~     smoking. Patients who undergo cardiac surgery may have higher levels of ROS because of their~     underlying medical conditions. In addition, the organized tissue trauma that occurs in the~     setting of surgery may serve to increase ROS levels further. In turn, the higher ROS levels~     may put patients at even higher risk for the development of AF. The investigators believe~     that increased levels of ROS may help potentiate a patient's development of AF. Accordingly~     the investigators aim to measure ROS levels before and after surgery to see if there are~     particular levels that predict the development of this abnormal heart rhythm. By developing a~     better knowledge of the relationship between ROS and AF, the investigators hope to better~     understand another possible method of detecting patients who are at the highest risk of~     developing AF before it occurs after surgery. If these patients are better identified, this~     may eventually lead to medical treatment to prevent AF; and hopefully this will result in a~     decrease of the malicious effects that result from developing this abnormal heart rhythm.~   "
207393|NCT00846521|"~     The main purpose of this study is to determine whether treatment with acarbose attenuates~     post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined~     by continuous glucose monitoring systems (CGMS). To this effect the current pilot study~     involves a 6 week intervention with acarbose given to all subjects with either impaired~     glucose tolerance or an area under the curve of >130 mg/dl during the screening oral glucose~     tolerance test. Three consecutive days of CGMS are then compared to before and during the~     intervention. The secondary objective addressed in this protocol is the collection of~     baseline measures of endothelial function in obese and lean children. Even though the~     duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and~     post intervention data would serve as preliminary data for anticipated future studies that~     assess the vascular effect of reduced post-prandial blood glucose levels.~   "
207394|NCT00846508|"~     This phase III study is designed to examine if low-risk, as defined by clinical and~     radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based~     chemoradiation, which is a recommended method by today's standard, have greater toxicities~     but similar survival rate as those treated by radiotherapy (RT) alone. Patients will be~     primarily treated with radiotherapy with same protocol, but without concurrent chemotherapy~     in the control arm, and with weekly cisplatin (40 mg/M2) for 6 courses in the study arm. This~     study will be conducted at all branches of Chang Gung Memorial Hospital except Chia-I.~      Patients will be randomized to either arm after stratification of risk factors. Each arm will~     recruit 104 patients who have no LN and systemic metastasis as defined by CT/MRI and FDG-PET.~     The primary end point is grade 3-5 late toxicities, and secondary end points are 1)~     recurrence free survival; 2) acute toxicity of treatments; 3) sites of recurrence; 4) quality~     of life; 5) total treatment time. It is expected to take 5 years to recruit enough case~     number.~   "
207395|NCT00846495|"~     Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during~     a 1-month Baseline Period, subjects will treat with their usual medication and document any~     warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization~     (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during~     Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit~     3.This study will compare the effectiveness of daily treatment vs. treatment during the~     pre-headache phase for prevention of migraine.~   "
207396|NCT00846482|"~     This study is for patients with advanced or stage II and III colon or rectal cancer. The~     primary purpose of this research study is to determine if a particular protein in the~     patient's blood will change when they receive treatment with a drug called oxaliplatin, which~     is used to treat the colon or rectal cancer. This protein is called ERCC-1. It is thought~     that the amount of this protein in the blood could influence the manner in which the patient~     responds to oxaliplatin.~   "
207397|NCT00846469|"~     The purpose of this study is to determine the usefulness of CCTA (Coronary Computed~     Tomography Angiography) in the emergency room setting to diagnose and predict the outcome of~     patients with chest pain who have a low to moderate risk of heart disease.~      And to also determine if the use of CCTA(Coronary Computed Tomography Angiography) is more~     cost effective (cost less) than the current standards of care treatments. To determine if~     patients who present to the emergency room w/low to moderate probability of having an ACS~     (Acute Coronary Syndrome) prefer CCTA (coronary computed tomography angiography)-based care~     compared to standard algorithm based care.~   "
207398|NCT00846456|"~     The study induces an immune response towards the stem-cell like part of glioblastomas in~     combination with standard therapy. The aim is to define and characterize the feasibility,~     potential adverse effects of such therapy and measure time to progression and survival.~   "
207399|NCT00846443|"~     The purpose of this study is to determine the recommended dose of pemetrexed and the maximum~     tolerated dose of radiotherapy when using concurrent pemetrexed/cisplatin/radiotherapy in the~     patients with local advanced non-small cell lung cancer.~   "
207400|NCT00846430|"~     Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called~     plexiform neurofibromas. These tumors can be defined as high-risk when they result in~     severe pain, physical disability, organ dysfunction and/or become life-threatening.~     Presently, there is no effective medical therapy to offer patients with high-risk plexiform~     neurofibromas, and surgery does not provide lasting help. This study will evaluate the~     effectiveness of two treatment combinations in patients with high-risk plexiform~     neurofibromas.~   "
207401|NCT00846417|"~     In this study, we will compare the quality of life in veterans having ICD who attend the ICD~     support groups to those who do not. We ask them to answer a set of quality of life~     questionnaires at baseline and then at 3,6,9 and 12 month visits. These questionnaires would~     be analyzed to assess if attending support groups made a difference. These results will be~     compared to a similar study done at Emory University on non veterans.~   "
207402|NCT00846404|"~     This study is to look at the differences between people who have evidence of abnormal heart~     relaxation (diastolic dysfunction) on sound wave pictures of the heart (an echocardiogram)~     compared to those who do not. If you have abnormal relaxation, it can be a cause of shortness~     of breath or can be present without knowing about it.~      A condition known as oxidative stress mayb e associated with this abnormal relaxation. This~     condition occurs when abnormal oxygen injures heart cells. We would like to learn if patients~     with abnormal relaxation have increased oxidative stress.~   "
207403|NCT00846391|"~     A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.~   "
207404|NCT00846378|"~     The size of a heart attack will be decreased by the use of timed balloon inflations to open~     the blocked blood vessel.~   "
207405|NCT00846365|"~     The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil~     combined with chlorthalidone, once daily (QD), in participants with moderate to severe~     essential hypertension.~   "
207406|NCT00846352|"~     This study will evaluate the outcomes of bronchoscopy in Bome Marrow Transplant (BMT)~     patients who develop lung infiltrates suspicious for infections of the lungs. It will consist~     of two groups, one group will receive bronchoscopy within thirty six hours of enrollment,~     while the other group will receive bronchoscopy five days after enrollment. The purpose of~     this study is to determine the ideal time for bronchoscopy in this group of patients.~   "
207407|NCT00846339|"~     Bupropion has different effects on D2 dopamine receptors according to genotype.~   "
207408|NCT00846326|"~     The investigators wish to evaluate the effects of decongestants like oxymetazoline and the~     lessening of this effect with time called 'tolerance'. The investigators will demonstrate a~     reversal of this tolerance with nasal steroids i.e. the investigators will show that nasal~     steroids protect against tolerance. This will tell us more on how the investigators can make~     this treatment effective and safe for patients suffering with allergic rhinitis.~   "
207409|NCT00846313|"~     The purpose of this randomised intervention study is to investigate to what degree patients~     with colorectal cancer benefit of dietary counselling regarding nutritional status, oncologic~     treatment and quality of life.~   "
207410|NCT00846300|"~     This study examines a brief physician counseling intervention to improved medication~     knowledge and compliance in family medicine patients who have diabetes, hypertension or high~     cholesterol.~   "
207414|NCT00846248|"~     Chromium is an essential nutrient for the maintenance of normal glucose tolerance and its~     deficiency causes insulin resistance. Chromium administration has also been shown in several~     studies to lower glucose and insulin levels in patients with type 2 diabetes. Accordingly, we~     propose to perform a placebo-controlled study of chromium picolinate administration in a~     cohort of non-obese, non-diabetic, insulin resistant subjects. These subjects will be~     randomized to 16 weeks of therapy with either 500 mcg twice a day of Chromium or placebo.~   "
207415|NCT00846235|"~     The aim of this study is evaluate the effect of three moisturising creams on Stratum corneum~     (SC) hydratation and barrier function.~   "
207416|NCT00846222|"~     The purpose of this study is evaluate the safety and feasibility of mild therapeutic~     hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for~     acute myocardial infarction complicated with shock~   "
207417|NCT00846209|"~     Prior studies have documented a high prevalence of patients misunderstanding prescription~     drug warning labels, placing them at risk for medication error.~      We sought to evaluate the effectiveness of 'enhanced print' drug warnings to improve patient~     comprehension beyond a current standard.A three-arm, controlled clinical trial was conducted.~     Patients were assigned to receive 1) current standard drug warning labels on prescription~     containers (standard), 2) 'enhanced' drug warnings with text rewritten in plain language~     (enhanced text), or 3) enhanced language and icons developed with patient feedback (enhanced~     text + icon).~      Setting: Two academic and two community health primary care clinics in Chicago, IL and~     Shreveport, LA.~      Patients: 500 adult patients consecutively recruited at each clinic. Main Outcome Measure:~     Rates of correct interpretation of nine drug warning labels as determined by a blinded panel~     review of patients' verbatim responses.~   "
207418|NCT00846196|"~     Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will~     consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2~     treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2),~     and exit procedures.~   "
207419|NCT00846183|"~     Local injury on two sights of endometrium are performed in 60 patients in their first IVF~     cycle and implantation rate are compared with fresh cycles without local injury.~   "
207420|NCT00846170|"~     Probiotics are defined as 'mono- or mixed cultures of live micro-organisms which, when~     applied to animal or man, beneficially affect the host by improving the properties of the~     indigenous flora'. Certain probiotics possess potent antibacterial and antiviral properties.~     Probiotic antibacterial activity may derive from the direct secretion of bacteriocins, the~     elaboration of proteases directed against bacterial toxins or through their ability to adhere~     to epithelial cells and thus exclude pathogens. The antiviral properties of some probiotic~     organisms, including the stimulation of interferon production, together with the~     well-documented efficacy of certain probiotics in the therapy of rotavirus diarrhea suggests~     the potential for a role for these agents in PI-IBS. The efficacy of some probiotics in~     preferentially relieving 'gas-related' symptoms may be related to qualitative changes in the~     colonic flora, as described earlier, or through the suppression of Small intestinal bacterial~     overgrowth (SIBO) , as there are reports of efficacy of probiotics in SIBO.~      The aim of the proposed study is to investigate whether the probiotic preparation co biotic~     can change the composition of fecal bile acids, fatty acids and bacterial composition, and~     whether such changes, if they occur, are correlated to a change in the symptoms of patients~     with IBS.~      Materials and methods:~      Patients diagnosed as having IBS by the Rome III criteria will be included in the study.~      Study subjects will be interviewed by a physician who will asses the diagnosis of IBS~     according to the Rome III criteria. Subjects will sign an informed consent and fill an IBS~     questionnaire and a health related quality of life questionnaire,~      A fecal sample will be obtained~      The subject will receive the probiotic product in a dose of 2 tablets/day, or a placebo~     containing all the active ingredients in the probiotic capsule, besides the bacteria, for 4~     weeks. They will then enter a washout period of 2 weeks in which they will not receive~     anything, and then another 4 weeks in which they will receive the probiotic product in a dose~     of 2 tablets/day, or a placebo. Patients will be randomized so that they will receive the~     study drug for 4 weeks and the placebo for 4 weeks, in a double-blinded fashion. Thus each~     patient will be his own control.~   "
207421|NCT00846157|"~     Primary objective:~        -  To compare the event free survival for 3years of R-CHOP plus Biocell Natural Killer Cell~          to R-CHOP therapy with DLBCL patients.~   "
207422|NCT00846144|"~     In the CDs rat model, beta-cell dysfunction and pancreatic exocrine damage are triggered and~     prevented by altering dietary Cu content suggesting a chronic and acute role for Cu. These~     abnormalities become apparent when the CDs rats are exposed to high sucrose low copper diet,~     triggering a vicious sequence of events: exocrine damage, recruitment of macrophages~     expressing IL-1beta leading to oxidative stress and even more reduction in the activity of~     Cu-dependent enzymes (chronic effect). When Cu levels are re-established (acute effect) they~     may prevent the inhibitory effect of IL-1beta on insulin release and may restore the activity~     of enzymes inhibited by IL-1beta. In this study we will identify humans with marginal Cu~     status that may benefit from copper supplementation to normalize their GSIS. These patients~     will be given a daily Cu supplement (3mg/d), or placebo for a period of 6 months. GSIS,~     pancreatic dysfunction and biomarkers of marginal Cu status will be measured in different~     blood components before and every 4 weeks during treatments or placebo.~   "
207423|NCT00846131|"~     A research study to determine the safety, efficacy, and tolerability of Therasphere® (also~     known as Y-90, or Y-90 Therasphere) combined with or without sorafenib (Nexavar®), in~     patients with hepatocellular carcinoma (HCC, or liver cancer), awaiting liver~     transplantation.~   "
207424|NCT00846118|"~     The purpose of this study is to verify whether pitavastatin prevents from cardiovascular~     events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.~   "
207425|NCT00846105|"~     The purpose of this study is to evaluate the efficacy of a novel PCR-based laboratory test~     for rapid detection of MRSA carriers to prevent transmission of MRSA in the Belgian acute~     care hospital setting.~   "
207466|NCT00845572|"~     This study will establish a bi-weekly Consta Club. Participants will begin taking Risperdal~     Consta after being recommended by their treating physician. As a part of the Consta Club~     attendees will receive their injection of Risperdal Consta and be educated about important~     mental health issues. Interviews with study participants will be completed every three months~     to determine the effectiveness of the change to Risperdal Consta and the bi-weekly group. The~     overall hypothesis is that the individuals in Consta Club will have a decrease in walk-in~     visits, emergency procedures and hospitalizations. It is also believed that individuals in~     Consta Club will have fewer symptoms and better levels of functioning.~   "
207569|NCT00844220|"~     The primary objective of this study is to analyze the clinical value of a therapeutic~     management strategy based on the results of coronary CT angiography and functional MRI. The~     clinical value of CT and MRI will be analyzed in patients with suspected coronary artery~     disease.~   "
224528|NCT00619554|"~     This study is designed to create an instruction set simple enough to be understood by~     migraine subjects as they were experiencing miagraine attacks.~   "
207426|NCT00846092|"~     Summary of Study Rationale Near-infrared light (NIR) via light-emitting diodes (LED)~     treatment promotes retinal healing and improve visual function following high intensity laser~     retinal injury by augmenting cellular energy metabolism, enhances mitochondrial function,~     increases cytochrome C oxidase activity, stimulates antioxidant protective pathways, and~     promotes cell survival. LED directly benefits injured neurons in the retina, the lateral~     geniculate nucleus, and the visual cortex, where perception occurs. From a public health~     perspective, a Light-Emitting Diode (LED) Array study is important to conduct because it has~     been approved as a non-significant risk (NSR) device for treatment of eye disorders, it has a~     low cost of treatment, and it may serve as an effective, non-invasive alternative or~     adjunctive treatment to laser photocoagulation, the current standard of care for DME.~      Study Objectives and Hypotheses~        1. To determine the effects of short term (3 month) near-infrared light (NIR) therapy on~          anatomic and functional abnormalities of diabetic macular edema as assessed by visual~          acuity, optical coherence tomography, multifocal electroretinography (mERG) and fundus~          bimicroscopy.~        2. To assess safety of short term near-infrared light therapy in eyes with diabetic macular~          edema.~   "
207427|NCT00846079|"~     Demonstrate the ability of muti-detector computed tomography to adequately perform stress~     testing will result in a veritable one-stop shop of non-invasive cardiac imaging that is,~     the ability to directly visualize heart arteries with high accuracy and to simultaniously~     determine the hemodynamic significance of any blockages visualized.~   "
207428|NCT00846066|"~     The purpose of this study was to compare the effect of the addition of hands on training by a~     pediatric dentist on the pediatric residents skills, confidence, opinions and practice~     related to preventive oral health.~   "
207429|NCT00846053|"~     The purpose of this research is to determine how a person's lungs will uptake~     [18F]fluorodeoxyglucose (FDG), as measured with positron emission tomography (PET) scanning~     in young cystic fibrosis patients.~   "
207430|NCT00846040|"~     Background:~      - Popular weight loss strategies often involve reducing an individual's consumption of~     carbohydrates or fat. However, no controlled study has been carried out to evaluate the~     effects of reducing carbohydrate versus fat consumption while keeping the other nutrients at~     standard levels to maintain an individual's weight. Researchers are interested in~     investigating how different restrictions of carbohydrates or fats affect the many processes~     involved in weight loss, including brain activity and blood and brain chemical composition.~      Objectives:~      - To determine the comparative effects of two controlled fat- or carbohydrate-restricted~     diets and an outpatient weight loss program on blood and brain chemical composition, weight~     loss (fat and lean body mass), and regional brain activity in lean and obese individuals.~      Eligibility:~      - Healthy individuals between 18 and 45 years of age who are either lean (body mass index~     between 18.5 kg/m(2) and 25 kg/m(2)) or obese (body mass index above 30.0 kg/m(2), weight~     less than 350 pounds) and are right-handed.~      Design:~        -  For obese participants, this study consists of four phases: an initial 2-day screening~          visit followed by two separate in-patient visits and one set of 12-week outpatient~          visits. For lean participants, this study consists of a scanning visit and a 2-day~          screening visit that will require an overnight stay.~        -  Lean participants~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and weight maintenance observations (food diaries and physical activity~          monitors).~        -  For the scanning visit, participants will receive balanced meals from the National~          Institutes of Health to consume for 2 days before the visit. During the scanning visit,~          participants will continue to eat the weight maintenance diet, complete questionnaires,~          and have a series of imaging studies (including positron emission tomography and~          magnetic resonance imaging tests) to evaluate brain response to food and other stimuli.~        -  Obese participants~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and weight maintenance observations (food diaries and physical activity~          monitors).~        -  During the first inpatient visit, obese participants will eat a weight-maintenance diet~          for 5 days to establish baseline measurements. Following the baseline diet, participants~          will then be switched to either a reduced-fat or a reduced-carbohydrate diet for the~          next 6 days. After the controlled diet, participants will have 3 days where they will be~          permitted to select food as desired from a computerized vending machine system.~          Participants will have frequent blood and other tests throughout this visit.~        -  After a 10-week washout period, participants will return for a second inpatient visit in~          which they will have the other (reduced-fat or reduced-carbohydrate) diet, with the same~          tests and procedures as before.~        -  After the second in-patient visit, participants will be assigned to a 12-week outpatient~          weight loss program with the goal of achieving at least 5% weight loss. During this~          program, participants will continue to have blood tests and imaging studies to evaluate~          the effects of weight loss on metabolism, brain reward circuitry, and regional brain~          activity.~        -  Participants who are available for long-term followup will have yearly visits for the~          next 5 years following the weight loss intervention.~   "
207431|NCT00846027|"~     This single-arm study assessed the efficacy and safety of first-line treatment with Avastin~     (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in~     patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel~     150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment~     cycle until disease progression, death, or withdrawal of consent.~   "
207432|NCT00846014|"~     The goal of this research is to use Helium-3 MRI to see the changes in airflow of the lungs~     at different times of an attack. These three stages are immediately after the attack, 1 month~     later and 4-6 months later.~   "
207433|NCT00846001|"~     The purpose of the study is to compare survivability and efficacy of the patients with severe~     ischemic heart failure after coronary artery bypass grafting alone and coronary artery bypass~     grafting with single-step implantation of CRT system (CABG alone vs CABG + CRT )~   "
207434|NCT00845988|"~     The primary goal of this study is to investigate metabolic changes and maintaining efficacy~     in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.~   "
207435|NCT00845975|"~     The purpose of this study is to determine if low level laser light therapy might help to~     relieve tinnitus in adults.~   "
207436|NCT00845962|"~     The purpose of this study is to compare the efficacity and the readiness for discharge~     between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.~   "
207437|NCT00845949|"~     Rheumatoid arthritis is a common chronic destructive arthritis. Major pathology change in~     rheumatoid arthritis is synovium hyperplasia with bone and cartilage erosion. Infiltrates in~     synovial tissue included type one and type two synoviocytes, B cells, T cells and~     fibroblasts. These cells will release many cytokines and chemokines, which will induce~     expression of adhesion molecules, release of variable enzyme from fibroblast and osteoclast~     and result in bone erosion.~      Recent study revealed that fibroblast-like synoviocytes (FLS) have some role in pathogenesis~     of rheumatoid arthritis.We believed CXCL12/CXCR4 ligand/receptor pair is important in~     chronicity of rheumatoid arthritis.~      CXCL12 polymorphism is studied in many disease. There is no related CXCL12 polymorphism study~     in rheumatoid arthritis. Our study intended to clarify the relationship between pathology,~     serology factor, CXCL12 polymorphism in rheumatoid arthritis in hope that new direction of~     therapy will be elucidated.~   "
207479|NCT00845403|"~     This study aims to gain an understanding of the key components of the immune response to~     hepatitis B present in cord blood of HBV infected mothers.~   "
207480|NCT00845390|"~     This study will be a qualitative survey to understand the expectations of defibrillator~     patients with regards to their device. It is unknown what ICD (implantable-cardioverter~     defibrillator) patients understand about their device and its purpose, thus we will be~     talking to them about their device. Also, we will be interested in studying their beliefs on~     how the ICD impacts their life expectancy and quality of life.~   "
207438|NCT00845936|"~     Atypical antipsychotics (AA) are broadly used to treat a variety of psychiatric and~     neurological disorders in children and adolescents. Weight gain is a common side effect of~     these drugs. AA induced weight gain can be the cause of the metabolic syndrome which is a~     major health concern, as well as cancer and significant psychological disorders. Weight gain~     may also lead to low compliance with AAs.~      A number of studies have been conducted in order to find a way to prevent, reduce or reverse~     AA induced weight gain in children and adolescents, but so far there is no commonly accepted~     treatment for the problem.~      Metformin is an antihyperglycemic drug, approved by the FDA for treatment of type 2 diabetes~     in children older than 10 years of age. The drug usually does not cause hypoglycemia, even in~     high dosage. Contraindications include renal impairment, hepatic disease, a past history of~     lactic acidosis (of any cause), cardiac failure requiring pharmacological therapy, or chronic~     hypoxic lung disease. The drug also should be discontinued temporarily prior to the~     administration of intravenous contrast media and prior to any surgical procedure. The~     reported incidence of lactic acidosis during metformin treatment is less than 0.1 cases per~     1000 patient-years, and the mortality risk is even lower.~      Acute side effects of metformin, which occur in up to 20% of patients, include diarrhea,~     abdominal discomfort, nausea, metallic taste, and anorexia. These usually can be minimized by~     increasing the dosage of the drug slowly, when indicated, and taking it with meals.~     Intestinal absorption of vitamin B 12 and folate often is decreased during chronic metformin~     therapy, and calcium supplements reverse the effect of metformin on vitamin B12 absorption.~      Three studies have studied the effect of metformin on weight gain secondary to use of AAs in~     adults and 3 other studies studied the effect of metformin in children and adolescents. Most~     of these studies have proved the drug to be efficient. No serious side effects have been~     demonstrated in any of these studies.~      Objective- To assess the effect of metformin on body weight of children and adolescents~     treated by AAs.~      Setting- recruitment and follow up would take place in the pediatric ward and outpatient~     clinic at the Ness- Tziona Mental Health Center.~      Participants- 30 adolescents aged 12- 20 years old, treated with AAs, who are overweight as~     defined by more than 10% of what is expected according to age and height.~      Importance of the Study~        1. Identify a medication capable of reducing or preventing weight gain by an AA agent.~        2. Identify an agent capable of improving compliance due to lower side-effect profile of~          AAs.~   "
207439|NCT00845923|"~     This proof of concept study is designed to evaluate the safety and efficacy of topically~     administered Civamide Patch for the treatment of moderate to severe daily pain associated~     with postherpetic neuralgia localized to the trunk, and with localized post-incisional~     neuropathic pain syndromes on the trunk.~   "
207440|NCT00845910|"~     This single arm study will evaluate the correlation between circulating endothelial cell~     levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer~     given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will~     be treated with docetaxel 60mg/m2 iv on day 1, and Xeloda 900mg/m2 po on days 1-14, of each 3~     week cycle, plus Avastin 7.5 mg/kg iv on day 1 of each 3 week cycle. The anticipated time on~     study treatment is until disease progression, and the target sample size is <100 individuals.~   "
207441|NCT00845897|"~     The purpose of this grant is to collect pilot data to assess the amount of botulinum toxin~     that needs to be injected into the calf muscles of subjects with diabetes mellitus,~     peripheral neuropathy, and a plantar ulcer to decrease muscle strength. We hypothesize that a~     decrease in plantar flexor muscle strength will temporarily decrease plantar pressure. The~     decrease in plantar pressure will provide temporary protection to the new tissue as it gains~     tolerance to high stress with the long term potential outcome as a decrease in the ulcer~     recurrence rate.~   "
207442|NCT00845884|"~     In spite of multiple attempts to improve the efficacy of first-line chemotherapy in advanced~     gastric cancer, the progress that has been achieved so far is rather limited, and many~     investigators are exploring newer regimens.A combination of decetaxel (Taxotere) with~     Cisplatin and 5-fluorouracil (5FU) is considered one of the most effective regimens in this~     disease. However, it is associated with significant toxicity which avoided its general~     adaptation by the medical community. The current study is exploring a newer way to administer~     these three drugs, hopefully making the regimen more comfortable, less toxic and maybe even~     more effective. We will do this by changing the dose and timing of Taxotere and Cisplating,~     by replacing protracted infusion of 5FU with tablets of Capecitabine (Xeloda) and by adding~     the anti-angiogenic drug, Bevacizumab (Avastin), which had shown encouraging results in this~     disease.~   "
207443|NCT00845871|"~     This single-arm, open-label, multi-center study will enroll 60 patients from approximately 20~     centers. All patients who meet study criteria and are currently taking, beginning or resuming~     treatment with Deferasirox will be allowed. The study will begin with a one month run-in~     phase, where all patients will be instructed to take Deferasirox according to their~     physician's current prescribing information.~   "
207444|NCT00845858|"~     To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray~     solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic~     gastroparesis.~   "
207445|NCT00845845|"~     The current pilot study assesses the use of magnetic resonance imaging (MRI) to quantify~     hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid~     supplementation (Lovaza) for the treatment of nonalcoholic steatohepatitis (NASH).~   "
207446|NCT00845832|"~     This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in~     combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose~     of methotrexate. In Part 1 of the study, patients will be randomized to receive either~     MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending~     doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm).~     In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera~     0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8~     and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.~      All patients will then be eligible to receive extension treatment withRoActemra every 4~     weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is~     <100 individuals.~   "
207447|NCT00845819|"~     The purpose of this study is to determine efficacy and toxicity of recombinant human~     epidermal growth factor (rhEGF) as a preventive drug of oral mucositis during intensive~     chemotherapy with stem cell transplantation in patients with hematologic malignancies.~   "
207448|NCT00845806|"~     The purpose of this study is to determine brain function in reading arabic diacritics.~   "
207449|NCT00845793|"~     This protocol is intended to test whether a focused nutritional intervention in hospitalized~     patients with type 2 diabetes can have an impact on long term eating habits, physical~     activity and anthropometric parameters.~      The rational is to use the food tray as a means of conveying simple and practical nutritonal~     and behavioral messages.~   "
207570|NCT00844207|"~     The primary objective is to estimate the relative bioavailability of fixed azithromycin /~     chloroquine combination tablets relative to co-administered individual tablets of~     azithromycin and chloroquine.~   "
207450|NCT00845780|"~     Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of~     persistent atrial fibrillation. It can however cause many adverse events, both cardiac and~     non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult~     especially because of high recurrence rates during the first month after cardioversion.~     Duration of atrial fibrillation, type of underlying disease, left ventricular function, left~     atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial~     fibrillation may be related to a highly arrhythmogenic period due to recovery from electrical~     remodelling. Late recurrences may be related to other triggers than recovery from electrical~     remodelling. In this study the investigators want to investigate the effect of amiodarone~     withdrawal on the occurrence of late relapses of persistent atrial fibrillation. Furthermore,~     the investigators want to investigate the effect of amiodarone withdrawal on the occurrence~     of amiodarone related adverse events as well as adverse events related to atrial fibrillation~     or underlying heart disease. The investigators also want to investigate which patients~     characteristics are and potential triggers have a prognostic value in the occurence of late~     relapses after amiodarone withdrawal.~   "
207451|NCT00845767|"~     Exposure to air pollution has been linked to increased cardiorespiratory morbidity and~     mortality. The exact component of air pollution that mediates this effect is unknown, but the~     link is strongest for fine combustion derived particulate matter derived from traffic~     sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs~     vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these~     detrimental vascular is unclear, but is thought to be via oxidative stress and altered~     bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of~     endogenous nitric oxide (NO) in the adverse vascular responses observed following exposure to~     diesel exhaust.~   "
207452|NCT00845754|"~     The purpose of this study is to determine if ketorolac, given after abdominal myomectomy,~     will decrease the frequency of post-oerative fevers as well as improve post-operative pain~     management.~   "
207453|NCT00845741|"~     This study is to evaluate the NGAL point of care device as an aid in the early risk~     assessment of AKI (acute kidney injury)in an All-Comers ED population.~   "
207454|NCT00845728|"~     This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks~   "
207455|NCT00845715|"~     The purpose of this study is to investigate whether there is a difference in the quality of~     life, ability to return to functioning (back to everyday life), the amount of experienced~     pain in patients who immediately move their shoulder versus patient who delay moving their~     shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a~     difference in the healing rates between these two groups.~   "
207456|NCT00845702|"~     The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA~     in patients suffering from renal arterial disease.~   "
207457|NCT00845689|"~     Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver~     and could hence be a critical factor of the postoperative outcome of patients undergoing~     liver surgery. In order to protect the liver from ischemic damage following interventions~     such as the Pringle Maneuver, preconditioning has been successfully applied in various animal~     models as well as in humans. Since ischemia inevitably leads to cell hypoxia and subsequnet~     release of endogenuous metabolites, the investigators hypothesize that instead of brief~     periods of ischemia, the exogenuous infusion of purine analogues may also protect against~     subsequent prolonged periods of ischemia. Moreover, after reperfusion, the antiinflamamtory~     action of purine ananlogue infusion can further attenuated liver damage.~   "
207458|NCT00845676|"~     This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV)~     infection during the first 6 months after acquiring HCV among people who already have~     pre-existing HIV infection will result in improved responses to HCV therapy with a shorter~     duration of infection.~   "
207459|NCT00845663|"~     To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x~     200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an~     auto-injection device (test).~   "
207460|NCT00845650|"~     The purpose of this study is to:~        -  evaluate the safety profile of a single intravenous administration of AIGIV (containing~          either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg,~          180 mg/kg or 360 mg/kg total IgG, GAMUNEX(R)(immune globulin intravenous (human) 10%~          caprylate/chromatography purified). GAMUNEX is a trademark of Talecris Biotherapeutics.~        -  evaluate the pharmacokinetic (PK) profile of a single intravenous administration of~          AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as measured by~          lethal toxin neutralizing antibody (TNA).~   "
207461|NCT00845637|"~     The purpose of this study was to assess the effect of eggplant extract capsules on the lipid~     profile of healthy individuals after an oral lipid overload test in a randomized,~     double-blind, placebo-controlled clinical trial.~   "
207462|NCT00845624|"~     The purpose of this study is to determine if there is a relationship between time spent out~     the targeted oxygen saturation range in preterm infants is associated with long-term outcomes~     such as Retinopathy of Prematurity.~   "
207463|NCT00845611|"~     The purpose of this study it to evaluate the safety and immune response of peptides (URLC10)~     emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent~     gastric cancer.~   "
207464|NCT00845598|"~     The purpose of this study is to see how a combination spray of azelastine and fluticasone~     (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in~     allergic rhinitis i.e. does azelastine permit the use of lesser steroid dose (steroid sparing~     effect) to achieve the same benefit.~   "
207465|NCT00845585|"~     The study intends to compare commonly used PTFE grafts with the biologic ovine graft~     Ominiflow II for below-knee bypass surgery in patients with peripheral artery occlusive~     disease with no autologous vein graft available. The hypothesis of this randomized trial is~     that that Omniflow II does not have a higher patency than PTFE over 36 months (one-sided~     test). An interim analysis will be performed at 18~   "
207602|NCT00843778|"~     To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on~     therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)~   "
225129|NCT00611468|"~     The purpose of this research study is to determine the best dose of the combination of two~     approved drugs, intravenous topotecan and oral erlotinib.~   "
207467|NCT00845559|"~     The primary aim of this study is to evaluate the effect of exenatide on daily glycemic~     excursions obtained by continuous glucose monitoring system (CGMS). The CGMS summary~     parameters that we are most interested in include:~        -  The percent of glucose values above 140 mg/dl and/or AUC of glucose values above 140~          mg/dl~        -  AUC of glucose values over 100 mg/dl during three days~        -  Maximal meal-related glucose excursions~        -  Three-day mean glucose (including low readings - below 100 mg/dl)~      Secondary Study Endpoints:~      Secondary endpoints will include:~        -  glucose tolerance status as assessed by OGTT~        -  Vascular function scores as assessed by PAT, FMD and step test.~        -  Biochemical markers of vascular health, including inflammatory markers, markers of~          oxidative stress and microalbuminuria.~        -  Changes in BMI~   "
207468|NCT00845546|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Ranbaxy and Schering (Claritin-D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate~     Extended-Release Tablets, in a fully replicated design, under fed conditions.~   "
207469|NCT00845533|"~     This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the~     antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children.~     Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We~     hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and~     this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this~     open-label trial in Burkina Faso. The target population includes residents, aged 6 months to~     10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms~     suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection~     criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic~     sampling for DP will occur on selected follow-up days.~   "
207470|NCT00845520|"~     The primary objective of this study is to evaluate, for the visual correction of aphakia, the~     safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and~     Light Delivery Device (LDD) in treating postoperative residual refractive error by providing~     a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the~     LDD.~   "
207471|NCT00845507|"~     The purpose of this research study is to test the safety and efficacy (how well it works) of~     exenatide as a treatment for weight gain associated with olanzapine in obese adults with~     Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder~      Exenatide has been approved by the FDA for the treatment of Type 2 diabetes.~      It has not been approved for the treatment of weight gain associated with olanzapine in obese~     adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective~     Disorder~   "
207472|NCT00845494|"~     The purpose of the study is to determine if a behavioral knowledge based education~     intervention will decrease medication transcription errors among professional nurses when~     admitting elder patients to a hospital. The hypothesis is those professional nurses who~     receive the behavioral-cognitive eduction medication taking intervention will have fewer~     medication errors than those professional nurses who do not.~   "
207473|NCT00845481|"~     The purpose of the study is to compare the anti-psoriatic effect of marketed products with~     Daivobet® ointment in a plaque test~   "
207474|NCT00845468|"~     Diabetes mellitus is a major risk factor for the development of ischemic heart disease, and~     patients with diabetes mellitus have a worse outcome following an acute myocardial infarction~     than non-diabetic patients. Furthermore, abnormal glucose metabolism below the diagnostic~     threshold of diabetes mellitus is also associated with increased risk of death compared to~     patients with a normal glucose metabolism. The frequency of abnormal glucose metabolism in~     acute myocardial infarction is high, and approximately 70% of myocardial infarction patients~     have diabetes mellitus, newly diagnosed diabetes mellitus or impaired glucose tolerance,~     leaving only 30% with normal glucose metabolism. The increased mortality among patients with~     acute myocardial infarction and abnormal glucose metabolism seems mainly related to a higher~     occurrence of congestive heart failure, suggesting that an abnormal glucose metabolism may~     play an important role among others in endothelial dysfunction, infarct healing and overall~     left ventricle function. This raises the question, whether patients with acute myocardial~     infarction and abnormal glucose metabolism have increased frequency of micro- or~     macrovascular disease or both.~      Coronary flow velocity reserve reflects the patency of the epicardial coronary artery in~     combination with vasodilator capacity of the microcirculation and may therefore offer a tool~     for assessment of macro- and microcirculation.~      This study will focus on the relation between coronary flow velocity reserve estimated by~     transthoracal Doppler echocardiography and mortality, risk for heart failure and left~     ventricle function after acute myocardial infarction stratified according to glycometabolic~     state~   "
207475|NCT00845455|"~     Personality type as a predictor to develop depression and reduction in quality of life among~     stroke survivals.~   "
207476|NCT00845442|"~     People who had paralysis of the vocal cords are often prevented from breathing by this~     problem because the cords will not open, and the patients have to wear a tracheostomy (neck~     breathing tube) to bypass this airway obstruction. This study examines the effects of vocal~     cord opening triggered by a pacemaker implanted over the chest wall. The device is connected~     to a nerve taken from a muscle close to the larynx (voice box) and implanted into the~     paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a~     few weeks, the stimulator is turned on and the level of vocal cord opening is assessed.~     Airway improvement is checked by pulmonary function tests and measurements of vocal cord~     opening. The ultimate goal of the study is to lead to situations where patients with~     bilateral vocal fold paralyses could get rid of the neck breathing tube to have less~     complications, be more comfortable and socially acceptable.~   "
207477|NCT00845429|"~     Primary Objective:~      To describe the immune response to a single administration of 2 formulations of the~     investigational cell-based influenza vaccines in healthy adult subjects.~      Secondary Objective:~      To describe the safety following a single administration of 2 formulations of the~     investigational cell-based influenza vaccines in healthy adult subjects.~   "
207478|NCT00845416|"~     The goal of the proposed research is to establish the validity of a newborn screening method~     for severe combined immunodeficiency (SCID). The assay to be used is developed on the basis~     of PCR quantification of T-cell receptor excision circles (TRECs) that is absent in SCID~     patients, thus correlating with the disease~   "
207481|NCT00845377|"~     Depression is one of the leading causes of emotional suffering in later life. It has been~     estimated that 2-5% of community-dwelling elderly people suffer from major depression, but~     according to recent studies, as much as 25 % have clinically significant depressive~     symptoms.Typically, depressive symptoms in the elderly are treated solely with~     antidepressants.~      The aim of this project is to study the effects of a comprehensive psychosocial intervention~     on the psychological well-being, quality of life and use of services in depressed elderly~     people. In addition, the processes of intervention are studied from the perspective of the~     participants as well as the service system. The research is conducted in collaboration with~     the city of Espoo. The design of the study combines clinical trial with qualitative process~     analysis.~   "
207482|NCT00845364|"~     Open-heart surgery causes injury of the heart muscle. Although this is usually mild,~     temporary and reversible, if it is severe it can endanger life and require additional high~     cost care. During surgery, techniques are used to protect the heart from injury, but these~     remain imperfect. This study assesses the effect of facilitating sugar metabolism (a more~     efficient fuel) by the heart muscle using the drug Perhexiline given before the operation.~     This treatment has a sound experimental basis for improving outcome. If this improvement is~     confirmed surgical results could be improved. The investigators will be studying heart~     function, heart muscle energy stores and chemicals which quantify the amount of heart muscle~     injury. The investigators' hypothesis is that Perhexiline will improve the protection of the~     heart by decreasing damage that may occur during heart surgery.~   "
207483|NCT00845351|"~     The objective of this pilot study is to establish the safety and tolerability of short-term~     therapy with bexarotene in patient's with Cushing's disease, and study the clinical,~     biochemical, and cellular effects of a preoperative five-day course of bexarotene in these~     patients before undergoing transsphenoidal surgery.~   "
207484|NCT00845338|"~     The objective of this study is to explore the effects of darifenacin in patients with~     multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and~     tolerability of darifenacin are already well established in idiopathic detrusor overactivity.~     Patients with multiple sclerosis and neurogenic detrusor overactivity without~     detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.~   "
207485|NCT00845325|"~     To objectively and subjectively assess two modes of commonly employed rehabilitation and~     confirm a superior method to treat patients following carpal tunnel release.~      One of the problems following carpal tunnel release (CTR) for carpal tunnel syndrome, and all~     hand surgeries, is the debilitation in the postoperative period. This relates to muscle~     atrophy and joint stiffness due to immobilization or relative inactivity in the postoperative~     period. Specifically, patients suffer increased days off from work, lost wages, and~     difficulties with activities of daily living affecting the patient and society at large. CTR~     is a very common procedure in hand surgery making it easy to study and important to optimize~     the postoperative care.~   "
207486|NCT00845312|"~     Pneumonia is a major cause of mortality and morbidity. A large body of evidence concerning~     the mortality risk factors in elderly patients with pneumonia has been reported; however,~     less is known about causes of mortality in patients of sixty and less. We noted a relatively~     substantial rate of short term mortality in this group of patients that were admitted to our~     institution. Therefore, we aimed to estimate the mortality rate and to identify risk factors~     for mortality among patients of sixty years old and less that were admitted with community~     acquired pneumonia.~   "
207487|NCT00845299|"~     The purpose of this study is to determine the effect of artificial tears preserved with~     Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety~     of the L-PPDS in subjects with OH or OAG following treatment.~   "
207488|NCT00845286|"~     The purpose of the study is to determine the myocardial function and vascular adaptation~     after strenuous exercise in association with genotype/polymorphisms. We aim to investigate~     the effects of extreme endurance exercise on the cardiovascular system. Furthermore, the role~     of the inflammatory response and adaptive mechanisms of the vasculature are examined.~     Subclinical injuries to the myocardium and vascular wall are being investigated.~   "
207489|NCT00845273|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3) factors considered to affect the safety and/or~     efficacy of this drug.~   "
207490|NCT00845260|"~     Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated,~     often chronic psychiatric disorder. The are effective pharmacological as well as~     psychological treatments for PD/A. Because of the lack of availability of the most effective~     psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments~     have been developed. One of those are Internet-based CBT. The aim of this study is to compare~     the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113~     patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks).~     The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is~     that treatments will show equal effectiveness.~   "
207500|NCT00845130|"~     Oxidative stress has been implicated in the development and complications of diabetes.~     Hyperglycemia and insulin resistance or insufficiency in diabetes can cause oxidative stress~     by excessive reactive oxygen species and can increase damage and alter antioxidant status in~     nerve cells. Antioxidant defense mechanisms protect against damage or restore oxidative~     damage. Glutathione, a powerful antioxidant plays a key role in the first line of antioxidant~     defense and seems to be a sensitive indicator of oxidative stress in various diseases such as~     diabetes. Glutathione functions in the regeneration of vitamin C which is another crucial~     antioxidant. Both hyperglycemia and insulin insufficiency inhibit uptake of vitamin C. The~     brain contains measurable amounts of glutathione that contribute to the antioxidant pool in~     the brain and guards against disease processes that are caused by oxidative stress. Since the~     brain is the most highly oxidative organ in the body and highly susceptible to oxidative~     stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain~     through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C~     will be studied.~   "
207501|NCT00845117|"~     The purpose of this study is to determine whether cultivated stem cell transplantation is~     effective for the treatment of patients wtih corneal stem cell deficiency.~   "
207491|NCT00845247|"~     Introduction: Case management (CM) has been proposed as a method for optimizing the course of~     treatment for complicated cancer patients. However evidence of the effect of CM is limited~     and methodologically rigorous research is needed.~      Aim: To analyze effects of Nurse CM in complicated cancer care.~      Methods: The study is designed as a two-arm randomized controlled trial (RCT) including~     approximately 280 colorectal cancer patients.~      Intervention group patients will be offered usual medical treatment plus supportive~     intervention from a case manager. Control group patients will receive usual medical and~     supportive treatment.~      The intervention: Case managers are registered nurses and possess thorough knowledge of~     cancer treatment and pathways. Core intervention elements: Planned and ad hoc personal and~     telephone contacts, surveillance of care pathways, coordination and dissemination of care~     plan (including transfer of patient-specific information to other departments and general~     practice).~      Primary outcomes: Patient evaluations of care pathways and Quality of Life~     (questionnaires).~      Secondary outcomes: Use of health care services and care process measures (The National~     Health Insurance Service Registry and The National Patient Registry; and GPs' evaluations of~     continuity of care (questionnaire).~      Schedule:~        -  Case management used to optimize cancer care pathways: A systematic Review has been~          published in BMC Health Services Research.~        -  The CM manual has been written. Questionnaires are under development and pilot testing.~        -  Two case managers have been appointed 1. January 2009.~        -  After training and pilot testing of the intervention the RCT will begin in March 2009.~          Inclusion period is 12 months.~   "
207492|NCT00845234|"~     An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially~     life-threatening cardiac arrhythmias. The device saves lives, but presents psychological~     challenges for patients. At present, there is a paucity of brief interventions for ICD~     patients designed for administration in a clinic setting that considers issues of cost, time,~     and available resources. The present study examined the impact of a brief cognitive~     behavioral (CBT) educational intervention on primary endpoints of patient acceptance and~     quality of life and secondary endpoints of depression and anxiety. It was hypothesized that~     the intervention would result in significant improvements primary and secondary endpoints for~     participants in the intervention group.~   "
207493|NCT00845221|"~     It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis,~     the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day),~     i.e. until the cytogenetic analysis.~      Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response~     is observed, the nature of the treatment suggested to the patient is left with the~     appreciation of the investigator.~      Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR)~     is obtained and maintained for at least 2 years.~   "
207494|NCT00845208|"~     Relapse is the most serious problem in alcoholism treatment. The overall aim of the present~     study was to determine if a treatment directed at changing the patient's social network, from~     one that reinforces drinking behavior to one that reinforces sobriety, can create the~     conditions necessary for long-term treatment success. In addition, we intended to determine~     if explicit reinforcement for this change of social network (Contingency Management or ContM)~     would be more effective than the same network support intervention without contingent~     reinforcement for change.~   "
207495|NCT00845195|"~     The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with~     Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal~     Spray for the treatment of seasonal allergic rhinitis.~   "
207496|NCT00845182|"~     Pioglitazone, a drug used in treatment of type 2 diabetes has been shown to improve insulin~     sensitivity in skeletal muscle, liver, and fat cells. Despite the beneficial effects of~     pioglitazone to improve insulin sensitivity and reduce cardiovascular disease in high risk~     type 2 diabetic patients, weight gain has been a limiting factor. Exenatide, another agent~     used for treatment of T2DM, improves glycemic control and promotes moderate weight loss. In~     this proposal we will examine the effect of combination therapy with pioglitazone plus~     exenatide on body weight, fat topography, beta cell function, glycemic control, and plasma~     lipid levels in subjects with type 2 diabetes mellitus compared to treatment with each drug~     separately. Assessment of beta cell function will be performed by measuring the maximal~     insulin secretory capacity using a maximal hyperglycemic stimulus combined with an~     intravenous arginine stimulus.~   "
207497|NCT00845169|"~     Exposure to air pollution has been linked to increased cardiorespiratory morbidity and~     mortality. The exact component of air pollution that mediates this effect is unknown, but the~     link is strongest for fine combustion derived particulate matter derived from traffic~     sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs~     vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these~     detrimental vascular is unclear, but is thought to be via oxidative stress and altered~     bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of~     endogenous nitric oxide synthase isoforms (NO) in the adverse vascular responses observed~     following exposure to diesel exhaust.~   "
207498|NCT00845156|"~     Subjects will be screened with a 2 hour oral glucose tolerance test. After this screening~     visit, their insulin resistance will be measured. Subjects will then be given either alpha~     lipoic acid (antioxidant) or placebo for 6 weeks. The insulin resistance test will be~     repeated after the 6 weeks. We believe these studies will confirm the beneficial effect of~     alpha lipoic acid on insulin sensitivity.~   "
207499|NCT00845143|"~     The purpose of this study is to assess the correlation of the predicted post-operative lung~     function with the observed post-operative lung function (FEV1 and DLCO) in patients who~     underwent surgical resection (FEV1 = Forced expiratory volume in 1-second. DLCO = Diffusion~     capacity for carbon monoxide. ppo = predicted postoperative.)and versus the gold standard~     QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion)~   "
207542|NCT00844571|"~     The purpose of this study is to determine whether the e-learning program about the~     recognition of child maltreatment is effective in nurses on the A&E department compared to a~     control group.~   "
207543|NCT00844558|"~     Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is~     one of the most disabling problems facing the growing population of older adults. The purpose~     of this research is to reduce disablement of older adults with symptomatic knee~     osteoarthritis.~   "
207502|NCT00845104|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine phosphate, work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Giving~     fludarabine phosphate together with rituximab and bevacizumab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving fludarabine phosphate together with~     rituximab and bevacizumab works in treating patients with B-cell chronic lymphocytic leukemia~     that has relapsed or not responded to treatment.~   "
207503|NCT00845091|"~     The current research study proposes to examine participants with implantable cardioverter~     defibrillators (ICD) who are randomly assigned to either an exercise training program~     intervention or a heart healthy education program intervention. We will look at changes in~     the functioning of the autonomic nervous system over time and between intervention groups. We~     are also going to be looking at changes in frequencies of the ICD participants' heart~     arrhythmias and ICD therapies (e.g., pacing, shock).; as well as, changes in exercise~     tolerance, psychological well-being, and quality of life.~   "
207504|NCT00845078|"~     This study examines the aesthetic outcomes of breast reconstruction after mastectomy for~     breast cancer in patients who require post-mastectomy radiation treatment. Patients will~     undergo autologous tissue breast reconstruction either in immediate fashion, prior to~     radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are~     acceptable and are practiced clinically. this will be an observational prospective cohort~     study.~      The investigators hypothesize that immediate autologous reconstruction patients who undergo~     subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom~     reconstruction is delayed until after radiation, with the additional benefit of avoiding the~     psychological side effects of breast amputation.~   "
207505|NCT00845065|"~     Based on previous experience with peginterferon alfa-2b/ribavirin in combination with~     boceprevir, the combination with peginterferon alfa-~      2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide~     utilization of both peginterferons and the clear benefit of the~      addition of boceprevir to peginterferon alfa-2b/ribavirin, it is important to demonstrate the~     safety and efficacy of boceprevir in combination with~      peginterferon alfa-2a/ribavirin.~   "
207506|NCT00845052|"~     Background: The occurrence of medical errors and their deleterious effects on quality of care~     delivered are widely recognized phenomena in healthcare today. This has spurned an aggressive~     nationwide campaign to improve the quality of care all hospitals throughout the country.~     Currently, there are numerous reports of quality improvement initiatives across medical~     centers in the United States. However, a review of the literature failed to identify any~     publications regarding targeted resident/housestaff involvement in hospital quality~     improvement and safety related activities.~      Purpose: To investigate and track housestaff attitudes on patient care, patient safety,~     communication and overall quality within the institution.~      Objective: To investigate, analyze and publish the results of this prospective study. The~     information obtained will help us and others understand whether proactive attempts to change~     housestaff culture can indeed change attitudes towards the better with regards to patient~     care and safety. It is assumed that improved attitudes ultimately translates into improved~     care and safety.~      Methods: Each residency coordinator in each clinical department will be asked to distribute a~     survey, which has already been validated for this type of investigation, to each resident in~     the respective program (see attachment).~      The Vice-President of Medical Affairs will provide a cover letter to help with the process.~     After a week, a reminder will be distributed by the coordinators to each resident asking them~     to fill out the survey. The surveys will be filled out anonymously. However, each participant~     will be asked to note their sex, department and year of postgraduate training. This process~     will be repeated every eight months until June of 2010. The Housestaff Quality council (HQC)~     has already distributed and collected this survey. The results of those surveys will be used~     in a retrospective part of this study. The results of (HQC) survey will be used to establish~     a baseline of the housestaff attitudes at the New York Presbyterian Hospital-Weill Cornell.~      Data will be stored on a password protected computer. The Institutional Review Board (IRB),~     Office of Human Research Protection and Food and Drug Administration and all appropriate~     federal oversight agencies may have access to those files.~   "
207507|NCT00845039|"~     The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and~     cetuximab in patients with metastatic colorectal cancer.~   "
207508|NCT00845026|"~     This study will assess time to discontinuation due to lack of tolerability among patients~     with schizophrenia receiving LY2140023, given orally twice daily for 24 weeks, versus those~     on atypical antipsychotic standard-of-care treatment. Lack of tolerability is defined as~     discontinuation due to adverse events (AEs). Patients who complete the active treatment phase~     will be eligible to continue to an optional 28 weeks of treatment extension phase. This~     extension phase will assess key safety and efficacy measures.~   "
207509|NCT00845013|"~     The purpose of this study is to describe the epidemiology of pulmonary hypertension in~     individuals with HIV infection and to investigate its pathogenesis. We propose to conduct a~     prospective observational cohort study to determine the association between highly active~     antiretroviral therapy (HAART) and viral suppression in HIV-infected patients who have been~     identified to have pre-clinical pulmonary hypertension (Aim 1). In addition, we will~     investigate the mechanistic role of the HIV-1 Nef protein and HHV-8 infection in the~     development and progression of pulmonary hypertension in individuals with HIV (Aim 2). We~     will also investigate endothelial function in HIV-infected patients with pulmonary~     hypertension (Aim 3).~   "
207510|NCT00845000|"~     This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third~     party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to~     be conducted in conformance with Good Clinical Practices. This trial will investigate the~     effects of single doses of preladenant and placebo on the dyskinesia and antiparkinsonian~     actions of a levodopa infusion. The study will examine 10 mg (low dose) or 100 mg (high~     dose) study drug, given as single, oral administrations in conjunction with intravenous (IV)~     levodopa infusion and oral carbidopa.~   "
207544|NCT00844545|"~     The purpose of this study is to determine whether eculizumab is safe and effective in the~     treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome~     (aHUS).~   "
207545|NCT00844532|"~     To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent~     System in subjects with atherosclerotic de novo or restenotic lesions in the native common~     iliac artery and/or native external iliac artery.~   "
207546|NCT00844519|"~     The purpose of this study is to determine the potentially beneficial aspects of CCR5~     inhibition on inflammation and endothelial function as measured by brachial artery reactivity~     in antiretroviral treated HIV patients with an undetectable viral load.~   "
207511|NCT00844987|"~     The main aim of the study is a comparison of serum and plasma concentration of VEGF (Vascular~     Endothelial Growth Factor), HGF (Hepatocyte Growth Factor) and PDGF (Platelet Derived Growth~     Factor) with markers of myocardial injury as troponin I, hsCRP, CK-MB and NT-proBNP assessed~     in patients with first episode of acute coronary syndrome (ACS) in their lives and the~     estimation of assumed value of VEGF, HGF and PDGF in prognosis of cardiovascular~     complications at 3 months follow up especially with respect to myocardial infarction (MI),~     exacerbation of angina, reintervention (PTCA,CABG), symptoms of heart failure, stroke,~     rehospitalization due to cardiovascular reasons and death. The dynamics of changes in serum~     and plasma concentration of growth factors in comparison with values of myocardial injury~     markers will be checked. For the realization of the purpose of the study biochemical~     measurements will be performed twice i.e. just after admission to hospital and 24h later.~     Area of a myocardial injury will be estimated by echocardiography examination.~   "
207512|NCT00844974|"~     The purpose of this research study is to learn more about cognitive deficits in people with~     certain mood disorders. The mood disorders are Major Depressive Disorder (MDD) and Bipolar~     disorder, depressed type.~      Cognitive deficits are problems with things like thinking and memory. People with cognitive~     deficits may have problems concentrating and paying attention. When talking, they may have~     trouble recalling a word they want to say. They may think slowly and have problems~     remembering things. These deficits can affect an individual's ability to work and function~     socially. Cognitive deficits that occur with depression may increase the risk of a relapse of~     major depressive disorder.~      We want to study the course of cognitive impairment in subjects as they are receiving~     treatment for their depression. We want to find out if their cognitive deficits get better,~     worse, or stay the same.~      We also want to learn more about a stress hormone called cortisol that is produced in the~     body. We want to study the relationship between cortisol and cognitive impairment. Recent~     research has shown that cognitive impairment may be more severe in people who have high~     levels of cortisol in their blood.~      We will also measure the levels of a protein in your blood called brain-derived neurotrophic~     factor (BDNF). BDNF helps the growth of new brain cells. It appears that the growth of new~     brain cells lessens when people are depressed. Treatment with antidepressant medications may~     cause BDNF levels to increase and return to normal. We are interested in studying the~     relationship between BDNF levels and cognitive impairment throughout treatment.~   "
207513|NCT00844961|"~     The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a~     gastroenterological clinic. The recruitment will be consecutive with all patients receiving~     the diagnosis being offered to participate. After recruitment and 3 week baseline measure of~     IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting~     list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All~     patients on waiting list are offered the same treatment as patients randomised to treatment.~      All patients are assessed 12 months after completion of treatment.~      Patients in treatment condition are hypothesized to experience significant reduction IBS~     symptoms and quality of life compared to patients on waiting list.~   "
207514|NCT00844948|"~     This Phase II SBIR study will replicate pilot study methods establishing computer-automated~     methods for assessing depression severity using interactive voice response system technology~     and demonstrating feasibility of obtaining measures of depression severity and treatment~     response through vocal acoustic analysis of speech samples obtained over the telephone. The~     study will automate vocal acoustic analysis methods, evaluate applicability to other patient~     populations (non-English speakers, children/young adult, and geriatric), and further develop~     multivariate acoustic models to enhance biomarker sensitivity to treatment response and~     prediction of the response likelihood for individual patients.~   "
207515|NCT00844935|"~     This research proposal has two main objectives. The first is to increase understanding of the~     underlying physiological interactions that occur between the cardiovascular, pulmonary, and~     ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous~     breathing. The second is to determine if heart rate variability, (HRV) a reflection of~     autonomic nervous system (ANS) activity, and autonomic information flow (AIF), a set of~     nonlinear measures derived from HRV, both measured in the intensive care unit (ICU) can~     predict patient outcomes including successful weaning and in-hospital recovery time after an~     episode of cardiopulmonary compromise requiring MV.~      Hypothesis 1. Transitions between mechanically supported ventilation and spontaneous~     breathing will disturb cardiovascular synchrony, altering the relationship of HRV, AIF,~     respiratory rate, and blood pressure;~      Hypothesis 2. More normal HRV and AIF values, measured during baseline MV and sedation~     awakening (a period immediately prior to SBT when sedative medications are discontinued) will~     be associated with easier weaning, and shorter intensive care unit (ICU) and hospital lengths~     of stay; more abnormal measurements will be associated with longer lengths of stay;~      Hypothesis 3. AIF is a more sensitive predictor of successful weaning from MV than HRV.~   "
207516|NCT00844922|"~     Patients who participated in the previous trial 28130, who were eligible, were entered into~     this trial. Patients who were randomized to placebo in the previous trial 28130 continued on~     placebo while patients who were randomized to Org 34517 (SCH 900636), regardless of dose,~     were titrated to 900 mg Org 34517. Patients in this trial took their study medication for 2~     weeks in order to study the safety and tolerability of Org 34517.~   "
207517|NCT00844909|"~     The purpose of this study is to evaluate the safety, tolerability and how the body affects~     the drug CNTO 136 in healthy Japanese and Caucasian volunteers.~   "
207547|NCT00844506|"~     The purpose of this study is to determine whether the addition of cyclophosphamide to the~     treatment with the p53-SLP vaccine improves clinical efficacy and immunogenicity of the~     p53-SLP vaccine in ovarian cancer patients.~   "
207603|NCT00843765|"~     Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project~     under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation~     and secondary prevention of ischemic stroke is same or better than that of WM.~   "
207628|NCT00843414|"~     To obtain the monocytes (white blood cells) from normal volunteers for the purpose of~     studying how proteins, fats, carbohydrates, as well as RNA and DNA for gene expression,~     relate to immunity. This information will be compared to other studies in patients with lung~     diseases such as Emphysema, Sarcoidosis, and Interstitial Pulmonary Fibrosis.~   "
207518|NCT00844896|"~     The objectives of this study are to test and validate a simple, feasible intervention to~     reduce pediatric burn traumatic stress in 0-5 year old children and their parents.~      We have refined and implemented an early post-burn psychosocial assessment and intervention~     for stress reduction for young children and their parents based on the DEF Protocol~     (Distress, Emotional Support, Family) from NCTSN's 'Pediatric Medical Toolkit for Health Care~     Providers,' and a burn specific version of the COPE (Creating Opportunities for Parent~     Empowerment)intervention.~      It is hypothesized that the combined DEF + COPE Intervention will be simple to implement and~     use under both experimental and real world conditions. The proof of the latter hypothesis~     will be that staff at Shriners Hospitals for Children-Boston will willingly incorporate it~     into routine care by the end of the project.~      We will evaluate, using an RCT design, the DEF + COPE Intervention by comparing outcomes for~     subjects who are randomly assigned to receive it with outcomes for subjects who are assigned~     to receive the DEF Intervention only.~      It is hypothesized that children in the DEF + COPE Intervention Group will show significantly~     greater decreases over time in pain and anxiety ratings, heart rate, PTSD total symptom~     scores and physiological symptom scores (such as heart rate and heart rate variability from~     baseline to follow up) than will children in the DEF-only group. Similarly, it is~     hypothesized that parents assigned to the DEF + COPE group will show significantly decreased~     scores on the Stanford PTSD measure.~   "
207519|NCT00844883|"~     This study will combine two therapies to treat patients with unresectable hepatocellular~     carcinoma; sorafenib, and drug eluting beads delivered intra-arterially. The purpose of the~     study is to establish the safety and the effectiveness of the combination therapy. The~     investigators hypothesize that the combination of the two therapies will not result in~     greater toxicities to patients than that expected for either therapy given alone.~   "
207520|NCT00844870|"~     After 4 weeks of training the hypothesis that the more natural training program would yield~     greater functional changes was proven correct.~   "
207521|NCT00844857|"~     The main goal of this study is to help answer the following research question(s) and not to~     treat the child's illness.~        -  Can this study drug make children with bipolar depression feel better?~        -  Does this study drug work better than a placebo (sugar pill)?~        -  Does this study drug cause side effects in children who take it?~        -  Is this drug safe to use in children? (The study drug is a mixture of olanzapine and~          fluoxetine)~   "
207522|NCT00844844|"~     The purpose of this study is to determine whether eculizumab is safe and effective in the~     treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic~     Syndrome (aHUS).~   "
207523|NCT00844831|"~     Patients with constipation often have bloating and abdominal distension. It is unclear if~     this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce~     small bowel and colon bacteria colonization, a change in the balance of stool microorganisms,~     and improve the symptoms of dyspepsia and constipation.~   "
207524|NCT00844818|"~     The purpose of the study is to find better ways to help parents quit smoking, thus improving~     their own health, the health of their children, and the health of other family members. This~     study tested the feasibility and acceptability of enrolling parents into a telephone quitline~     during postpartum hospitalization. Half of the parents in the study received quit smoking~     assistance (intervention group), and half of the parents did not (control group). The~     percentage of parental smokers who are enrolled in quit smoking programs by the study~     follow-up will be greater in the intervention group than in the control group.~   "
207525|NCT00844805|"~     The primary objective of this study was to assess the proportion of participants in the~     infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of~     participants with moderate-to-severe active axial spondyloarthritis and disease duration of~     ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission~     criteria.~   "
207526|NCT00844792|"~     The purpose of this study is to see if an intervention of antioxidants(vitamin E, selenium~     and lycopene) can change (reduce) prostate tumor size and alter certain markers that can~     affect tumor growth and prostate cancer aggressiveness.~   "
207527|NCT00844779|"~     Non alcoholic fatty liver diseases (NAFLD) are represented by two main pathological~     conditions, hepatic steatosis (HS) and non alcoholic steatohepatitis (NASH), which are~     characterized by the accumulation of fat in the liver. The diagnosis of these two entities is~     achieved by histology and neither imaging nor biochemical markers are accurate enough to~     discriminate them. At the contrary of HS, NASH features hepatocyte necrosis, inflammation and~     fibrosis of variable intensity that could progress and ultimately evolve to cirrhosis.~     Therefore, it is important to distinguish between HS and NASH in order to treat the patients~     accordingly. In this study, the investigators aim to understand the molecular mechanisms that~     govern the transition from benign steatosis to complicated NASH. The investigators will~     analyze by Q-RT-PCR and DNA microarray technologies in the liver of obese patients, the~     expression of genes that are susceptible to be involved in the pathogenesis of NAFLD and~     identify the potential signaling pathways responsible for the progression of the disease.~   "
207528|NCT00844766|"~     The hypothesis underlying this study is that whilst there is no home-screening test for~     lactose intolerance, this test would have significant value as lactose tolerance tests and~     breath hydrogen tests are expensive and time consuming. Therefore, it would be highly~     beneficial to validate a simple home-screening test.~      This study will validate a simple home-screening test that uses lactose and not milk.~   "
207562|NCT00844311|"~     The purpose of this trial is to study whether addition of different doses of human chorionic~     gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve~     the number of top-quality embryos.~   "
207563|NCT00844298|"~     RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     nilotinib together with combination chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving nilotinib together with combination~     chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.~   "
207564|NCT00844285|"~     The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as~     compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is~     3045 patients and it's objective is to monitor patients for approximately 8 years.~   "
207529|NCT00844753|"~     The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent~     Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive~     Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention~     Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where~     the atomoxetine will have a dose titration over a 6 week period. All children will be seen~     weekly during this titration period, with additional visits at Week 8 and Week 10. Families~     assigned to the PMT arm will have an additional weekly meeting with a clinician for a total~     of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with~     their children. Subjects who are clinical responders (ADHD Responders and Compliance~     Responders) from the 10 week study period will be followed every 4 weeks in a 24-week~     extension study. Subjects who are clinical nonresponders will continue in PMT if they~     received PMT during the double-blind phase, and they will receive an open trial of~     atomoxetine if they were on placebo during the double-blind phase. All subjects (responders~     and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for~     24 weeks after the completion of the double-blind phase.~   "
207530|NCT00844740|"~     Currently, large oral doses of phosphate and 1,25(OH)2D (calcitriol) are the standard~     treatment of patients with familial hypophosphatemic rickets (XLH). While this therapy is~     effective in healing the rickets, it is often limited by development of complications due to~     the high dose of medications required to achieve cure. Among them are the development of~     calcifications in the kidneys and secondary hyperparathyroidism (HPT) which in some patients~     may cause complications like high blood calcium level, high blood pressure and damage to the~     kidney. A drug to treat secondary hyperparathyroidism was just developed. In a short term~     study we found that it might help the treatment of XLH, by allowing the use of lower doses of~     the both phosphate and calcitriol. In the present study we will learn if indeed the addition~     of this new medicine (Cinacalcet) to the long-term treatment will allow the use of lower~     doses of both phosphate and calcitriol and consequently lower the risk of complications.~   "
207531|NCT00844727|"~     Preliminary data indicate a protective effect on the development of duodenal polyps by coxib~     treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for~     1 year would stop or reverse the development of premalignant adenomatous lesions in the~     duodenal mucosa of FAP patients.~   "
207532|NCT00844714|"~     The purpose of this investigation is to determine the effects of Rituxan therapy in~     individuals with rheumatoid arthritis on endothelial function and other markers of~     endothelial function~   "
207533|NCT00844701|"~     The purpose of this study is to evaluate the relationship between craving to smoke and areas~     activated in brain. The researchers are using functional magnetic resonance imaging (MRI)~     that measures brain blood flow, or perfusion, to study this brain activation.~   "
207534|NCT00844688|"~     For the majority of patients, metastatic HCC is incurable and patients should be considered~     candidates for clinical trials when appropriate. Till recently there was no worldwide,~     approved local or systemic therapy for advanced HCC and the available therapies for advanced~     unresectable and/or metastatic HCC have limited clinical values, with low response rates and~     little impact on the natural history of the disease. Furthermore, the toxicities associated~     with these agents can be severe, requiring careful patient selection, and this dramatically~     decreases the number of patients who may benefit from therapy. The SHARP trial established~     the survival benefit of Sorafenib in Advanced HCC but the results yet remain humble. The need~     for more effective therapies is still there.~      Study Objectives~      The primary objective of this phase II study is to evaluate the efficacy and safety of~     Sorafenib and Gemcitabine combination in patients with advanced HCC.~      Safety data and limited efficacy data will be collected for this combination in the study.~     All Drug-Related Adverse Events, all Adverse Events NCI CTCAE Version 3.0 Grade 3 or higher,~     and all Serious Adverse Events regardless of causal relationship to study drugs will be~     recorded in this study.~   "
207535|NCT00844675|"~     The purpose of this study is:~        -  To examine if oral administration of Pariet (proton pump inhibitor, 20mg tablets, twice~          daily for 5 days) before Endoscopic mucosal resection(EMR) exhibits preventive effects~          of ulcer bleeding compared with placebo group (preoperative administration of placebo)~        -  To evaluate the effects on the suppression of acid secretion of preoperative~          administration of an Proton pump inhibitor~   "
207536|NCT00844662|"~     Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food,~     reducing the amount that the body can absorb.~      The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in~     subjects requiring haemodialysis, compared with a marketed phosphate binder, sevelamer~     hydrochloride.~   "
207537|NCT00844649|"~     Phase III Metastatic Pancreatic Cancer~   "
207538|NCT00844636|"~     The objective of this study was to determine if blunt needle use during cesarean section~     closure protects against glove perforation and percutaneous injury to the surgeon and~     surgical assistant. A secondary objective was to determine physician satisfaction with blunt~     needles during the surgery.~   "
207539|NCT00844623|"~     The purpose of this study is to determine whether activation of a prodrug after intratumoral~     gene transfer is safe in humans, and to determine dose levels for further clinical~     development.~   "
207540|NCT00844597|"~     The specific aim of this Phase I/II study is to assess the safety of intravenous administered~     Morpholino oligomer directed against exon 51 (AVI-4658 PMO).~   "
207541|NCT00844584|"~     Atrial fibrillation (AF) is a common supraventricular arrhythmia, the incidence of which~     increases with age. The aim of treatment of atrial fibrillation is to restore sinus rhythm~     and return the heart to atrioventricular synchrony, avoiding the risk of thromboembolism. The~     fact that pharmacological therapy of AF is at best 50% effective has led to a search for~     surgical approaches over the last 20 years.~      Maze procedure was a classic method to treat AF. However, it is such a complex procedure that~     very few surgeons have adopted it. A few minimally invasive procedures to create transmural~     lesions which mimic MAZE procedure have been introduced. One of the mostly favored methods is~     catheter-based radiofrequency ablation, another one is video assisted epicardial~     radiofrequency ablation through small thoracic incisions in operating room.~      Recently, we invented an epicardial radiofrequency ablation method under totally~     thoracoscope, which further minimized the surgery trauma and increased the cosmetic effect.~   "
207548|NCT00844493|"~     This study will validate a model for testing new vaccines designed to protect against~     intestinal infections with enterotoxigenic Escherichia coli (ETEC). ETEC is one of the most~     common causes of diarrhea in developing countries and is a common cause of travelers~     diarrhea. Vaccines are now being developed and their development will be facilitated if we~     have a valid model for testing these vaccines in human volunteers. We anticipate that the new~     vaccines will be given to volunteers and they will then be given a dose of virulent ETEC~     bacteria. If the vaccine is effective, the volunteers should not development diarrhea, but if~     the vaccine is not effective, the volunteers will have diarrhea for a few days.~      During this study, we will validate a minimum dose of virulent ETEC bacteria which is~     sufficient to cause diarrhea in healthy adult volunteers and to identify conditions that can~     make this model reliable.~      We will also determine, in a follow-up group of volunteers, if being exposed to the ETEC~     bacteria previously will protect against a subsequent illness when they are exposed to the~     same bacteria a second time. We believe that the previously exposed group will be protected~     and we will study the immune response to these exposures to help design vaccines that can~     accomplish this kind of protection.~   "
207549|NCT00844480|"~     This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be~     administered intravenously to people who have suffered an acute spinal cord fracture. The~     goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this~     population. Outcome measures will include bone density determinations over a one year period.~   "
207550|NCT00844467|"~     The purpose of this study is to establish retrospectively the incidence rates of invasive~     pneumococcal disease in children aged less than 5 years. The investigators allocate the El~     Hasa region for the study because it has higher incidence of sickle cell anemia. The study~     will include data from 2003 to 2007(before introduction of the vaccine) and then for 2008 and~     2009 (after introduction of the vaccine).~   "
207551|NCT00844454|"~     The purpose of this study is to compare the effectiveness of percutaneous ethanol ablation~     using a multi-pronged needle (QFEA) with that of percutaneous radiofrequency ablation (RFA)~     in the treatment of early-stage hepatocellular carcinoma (HCC).~   "
207552|NCT00844441|"~     RATIONALE: Gathering information about patients with myelodysplastic syndrome or acute~     myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital~     until blood counts return to normal, may help doctors learn more about a patient's quality of~     life, use of medical services, and the cost of these services.~      PURPOSE: This clinical trial is studying early discharge and outpatient care in patients who~     have undergone chemotherapy for myelodysplastic syndrome or acute myeloid leukemia.~   "
207553|NCT00844428|"~     The purpose of this study is to determine whether eculizumab is safe and effective in the~     treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic~     Syndrome (aHUS).~   "
207554|NCT00844415|"~     To investigate the safety and tolerability of dabigatran etexilate capsules in a small group~     of eight adolescent patients.~   "
207555|NCT00844402|"~     Primary biliary cirrhosis (PBC) is frequently associated with hypercholesterolemia and~     possibly with an increased cardiovascular morbidity and mortality. Statins lower serum~     cholesterol levels and may thus improve the cardiovascular risk in PBC patients. The aim of~     our study therefore was to prospectively examine the efficacy of low-dose atorvastatin on~     indicators of cardiovascular risk such as dyslipidemia and vascular function as well as~     safety in patients with PBC.~   "
207556|NCT00844389|"~     The purpose of the study is to evaluate if near-to-infrared light stimulation can improve~     retinal ganglion cell function in glaucomatous patients.~   "
207557|NCT00844376|"~     The purpose of this study is to estimate the relative bioavailability of the commercial~     tablet with one prototype extemporaneous preparation suspension formulation, to assist with~     internal decision making on formulation development.~   "
207558|NCT00844363|"~     Ultra-violet light B (UVB) therapy has been used by dermatologists to treat psoriasis for~     decades. Only a few studies have begun to dissect the mechanism of how NB-UVB therapy causes~     lesion resolution. Results from this study will aid in identifying other diseases that may be~     treated successfully with NB-UVB. If we can identify the mechanism of action of this therapy,~     this may give us additional new therapeutic targets for psoriasis and other diseases. Our~     overall hypothesis is that UVB induces changes that will indicate a mechanism of action of~     this therapy in psoriasis.~   "
207559|NCT00844350|"~     The specific aims of this study were to assess whether letrozole as an aromatase inhibitor~     plus hCG or OT alone, or in combination compared with CC, improves ovarian response.Ethical~     design of this study is based on the ethical guidelines of the Iranian Medical and Health~     Ministry which is accepted by Tabriz medical university ethical committee .~   "
207560|NCT00844337|"~     The primary aim is to establish the non-inferiority of several simplified, home-based~     antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric~     treatment of suspected sepsis in Bangladeshi young infants whose parents refuse~     hospitalization. Three alternative regimens will be compared with a standard (reference)~     regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven~     days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin~     twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days~     followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once~     daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily~     for five days.~      Hypothesis~      The proportion who fails treatment will be 10 percent in the reference group and the~     alternative treatment groups. An alternative therapy will be considered non-inferior to the~     standard therapy if the failure rate in the alternative therapy exceeds the failure rate in~     the injectable therapy by less than 5 absolute percentage points.~      Secondary Objectives:~        -  To identify baseline clinical predictors of treatment failure in severe infections in~          young infants.~        -  To determine the proportion of relapse (young infants who were considered cured by day 7~          but developed any of the signs of suspected severe infection by day 14).~   "
207561|NCT00844324|"~     This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single~     centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial~     oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan~     cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.~   "
207571|NCT00844194|"~     The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP)~     patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given~     as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by~     the change in Brief Pain Inventory (BPI) 24 hours average interference score from baseline to~     after 12 weeks. A clinically relevant improvement will be demonstrated if the confidence~     interval for the mean change from baseline does not lie above the clinically relevant change~     of -1.35. If statistically significant results are obtained for the DPNP patients with MDD,~     then the same evaluation will be performed for the DPNP patients without MDD in another~     confirmatory analysis.~      As secondary objectives the study will compare the two groups (MDD+/MDD-) regarding efficacy~     of duloxetine on BPI severity scales, the distribution of different percentages of pain~     reduction among the patient population, and the patients and physicians impressions of~     severity and improvement of pain.~      The study will also compare treatment outcomes regarding patient-relevant functionality and~     quality of life (QoL) between the two groups (MDD+/MDD-) by evaluating each single BPI~     interference item, the Short Form 12 (SF-12) Health Questionnaire and the West Haven~     Multidimensional Pain Inventory (MPI).~      As a third group of secondary objectives the efficacy of duloxetine of the psychological~     symptoms (e.g. depression) of DPNP patients with or without depression will be assessed using~     the Hamilton depression scale, the Beck Depression Inventory-II and the hospital Anxiety and~     Depression Scale.~      Further the effect of duloxetine treatment on fasting blood glucose (FBG) and hemoglobin A1c~     (HbA1c) will be evaluated.~      To monitor safety and tolerability, treatment discontinuation rates, treatment emergent~     adverse events, change in vital signs, laboratory results and suicidal thoughts will be~     assessed.~   "
207572|NCT00844181|"~     Our central hypothesis is that baroreflex sensitivity is attenuated in black women compared~     to white women, and that this dysregulation will be apparent during orthostatic challenges.~     We expect that the cumulative stress index (CSI), a measure of maximal orthostatic tolerance,~     is higher in Black women (BW) compared to White women (WW).~   "
207573|NCT00844168|"~     This phase I trial studies the side effects and best dose of sorafenib tosylate in treating~     patients with liver cancer who have undergone a liver transplant. Sorafenib tosylate may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the tumor. Giving sorafenib after liver transplant may be an effective~     treatment for liver cancer~   "
207574|NCT00844155|"~     This proposed pharmacokinetic study will test the hypothesis that in critically ill patients~     with respiratory failure requiring mechanical ventilation such as might be anticipated to be~     needed to treat patients with severe influenza pneumonia, oseltamivir administered enterally~     via nasogastric tube, with and without concomitant food or alimentation, will have similar~     oral bioavailability to that observed in ambulatory adults ill with influenza in whom~     oseltamivir therapy 75 mg BID is efficacious and well tolerated. Additionally, this~     experiment will test the hypothesis that increasing the dose (150 mg), with and without~     concomitant enteral feeding, will show a proportionate increase in bioavailability. Relative~     oral bioavailability will be assessed from plasma concentration vs. time over 12 hrs and~     urinary recovery of drug from 0 to 48 hrs after administration.~   "
207575|NCT00844142|"~     Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in~     patients with moderate to severe active early axial spondyloarthritis duration of ongoing~     axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions~     in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters~     are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years.~     Comparisons will be made within the two treatment arms and compared to baseline. At the 1~     year extension phase comparisons will be also made between year 1 and year 2. At the end of~     the extended study a pelvic x-ray is planned.~   "
207576|NCT00844129|"~     The purpose of this study is to determine the incidence and clinical history of~     neurofibromatosis type 1-related spinal abnormalities.~   "
207577|NCT00844116|"~     The investigators aim to demonstrate that spirometry performed on line with a technician in~     a remote place from the patient has the same efficacy as the one performed personally. As a~     previous study the investigators analyzed the inter-observer agreement between two pulmonary~     function technicians from both centers taking part in the study: San Pedro de Alcántara~     Hospital (Cáceres) and Carlos III hospital (Madrid). The main study will be broad (226~     patients derivates from primary care to pneumology consultation), prospective, aleatorized,~     crossed, blind and controlled. The patients will be aleatorized in two groups: 1) personal~     spirometry: performed in a conventional way; 2) telematic spirometry: performed remotely on~     line. The same pulmonary function technician, who will carry out the spirometries~     personally, will be located in a nearly room. The technician will control the computer office~     and the spirometer software in the patients's room with another computer. By means of~     teleconference, the technician will indicate the patient to start the maneuver. After 20~     minutes from the end of the first spirometry, the patients will complete the protocol of the~     following group. The mean values of FVC, FEV1 and FEV1/FVC, the mean time of spirometry~     performance, the mean number of spirometric maneuvers performed, are compared between both~     groups by t proof for paired data. The comparison of the percentage of proofs with non~     acceptability or reproducibility criteria will be made by X2 test. The analysis will be made~     blindly. The inter-observer and intra-observer agreement will be evaluated by analysis of~     intraclass correlation for FVC and FEV1 values.~   "
207578|NCT00844103|"~     The purpose of this study is to determine how well tolerated and safe AZD8566 is when given~     over 10 days, at different dose levels. This study will also determine how AZD8566 is~     distributed around the body and how it leaves the body.~   "
207579|NCT00844090|"~     In spite of several new medications and insulins for the control of blood sugars in patients~     with diabetes, a large number of patients do not have good control. This likely due to~     inability to carry out regular activities and self-care behaviors such as taking meds~     regularly, keeping a good diet, exercise etc. This inability to carry out self care lifestyle~     changes may be due to a condition called apathy. Apathy is a lack of motivation and~     persistence. In this study we will attempt to treat apathy with a medication called~     methylphenidate for 6 months and see if blood sugar/diabetes control improves.~   "
207613|NCT00843609|"~     The purpose of this study is to determine if the incidence and duration of hypoglycaemia (low~     blood sugar) is reduced through the use of the FreeStyle Navigator Continuous Glucose~     Monitoring System in people with Type 1 diabetes mellitus at good glycemic control. The~     investigators hypothesize that the access to real-time continuous glucose concentration data~     along with alarms will enable people with type 1 diabetes at reasonable metabolic control to~     reduce the time spent in hypoglycaemia.~   "
207614|NCT00843596|"~     the purpose of this study is to show that the vacuum control surgical bleeding helps stop~     bleeding extraMD (MD: Medical Device) at the orifice of the retrograde cannulation during a~     heart with Extra-corporeal circulation (ECC),~   "
207580|NCT00844077|"~     Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current~     treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for~     changes (dysplasia). Pathologists vary dramatically in their interpretation of Barrett's~     Metaplasia versus dysplasia and consensus is very difficult to achieve. The investigators~     propose a longitudinal study of subjects with confirmed Barrett's intestinal metaplasia~     without dysplasia to look for predictive factors for transformation to dysplasia or cancer.~     Potential biomarkers can be found in serum, plasma, urine, frozen or fixed Barrett's and~     Normal esophageal mucosa. In addition, the investigators are testing a brushing technique~     from CDx, Inc. for predictive factors. Subjects must have pathologically confirmed Barrett's~     intestinal metaplasia without history of dysplasia to be on this longitudinal study.~   "
207581|NCT00844064|"~     In this national Phase I dose-escalation study the safety and tolerability of AP 12009 is~     evaluated in adult patients with advanced tumors known to overproduce TGF-β2, who are not or~     no longer amenable to established therapies.~   "
207582|NCT00844051|"~     Rates of confirmed influenza illness in vaccinated and non-vaccinated children will be~     compared between schools with and without vaccination programs. The investigators hypothesize~     that in addition to lowering rates of influenza in vaccinated children, raising vaccination~     rates by 30-40% through school-based vaccination programs will decrease incidence of~     influenza in non-vaccinated children attending those schools compared to non-vaccinated~     children in schools with low vaccination rates.~   "
207583|NCT00844038|"~     Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance,~     with skin involvement and mucous membranes, related to several factors, such as, viral or~     bacterial infections and mainly the administration of medicines, in general painkillers and~     antibiotics. The objective of this work is report the emergence of ulcerative vesicle -bubble~     chronic disease in areas of lips, gum, tongue and genital mucous membrane in a 26 year-old~     patient, leucoderma and masculine gender, in treatment of breathing infection with~     sulfametoxazol-trimetropima, having been diagnosed as syndrome of Steven-Johnson.~   "
207584|NCT00844025|"~     The investigators propose that clinical pharmacist interventions would reduce the rate of~     adverse drug events in elderly patients taking potentially inappropriate medication.~   "
207585|NCT00844012|"~     Because ovarian sex steroids fluctuations during the menstrual cycle are implicated in the~     pathogenesis of the endometriosis-related chronic pelvic pain (CPP), the oral contraceptives~     (OCs) are used with non-contraceptive indication for this disorder.~      To date, OCs are widely used as medical treatment in patients with endometriosis, in~     addition, they are recently experimented as post-surgical therapy. Traditional cyclic~     regimen, with 21 days of active pills with 7 days of placebo or suspension, is usually~     adopted. Furthermore, recent studies suggested that long-term continuous OCs use can be~     effective in the postoperative period both as second- and third- line treatments after cyclic~     regimen failure. In these studies a combined treatment with ethinilestradiol (0.02 mg) plus~     desogestrel (0.15 mg) were used and compared with baseline or ciproterone acetate.~      A recent study showed a deeper ovarian and endometrial suppression with continuous OCs in~     comparison with cyclic OCs, providing a physiological rationale for continuous OCs use for~     noncontraceptive indications. Furthermore, to date, no study compared post-operative~     continuous versus cyclic OCs in patients with endometriosis-related CPP.~   "
207586|NCT00843986|"~     This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin~     antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated~     heart failure (ADHF).~   "
207587|NCT00843973|"~     The purpose of this study is to find out if the cells in bone graft samples collected using a~     reamer are similar to the cells in bone graft samples collected using the iliac crest bone~     graft method.~   "
207588|NCT00843960|"~     Medication-related non-adherence increases the risk of rejections and associated graft loss~     after solid organ transplantation. A randomized controlled intervention will use adherence~     enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence~     will be assessed by patients' self-report and based on immunosuppression level. All~     non-adherent patients will be randomly designed to either intervention or control group.~     Multi-module interventions include patient education, electronic medication event monitoring,~     and a combined behavior and symptom management. Longitudinal follow-up is envisioned after~     initial intervention.~   "
207589|NCT00843947|"~     This is a Phase II trial designed to evaluate the efficacy and toxicity of RIST, conditioned~     with fludarabine and busulfan, using G-CSF mobilized PBSC from an HLA-matched sibling or an~     unrelated volunteer donor. The primary endpoint of this study is day 100 TRM (Treatment~     Related Mortality). Secondary endpoints include response, engraftment times, acute and~     chronic GVHD, chimerism, toxicities, progression-free survival and overall survival.~      Objectives~        -  To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients~          with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan~          intravenous (Busulfex™).~        -  To evaluate progression-free survival and overall survival.~        -  To determine donor chimerism.~        -  To assess the risk of acute and chronic graft versus host disease (GVHD).~   "
207590|NCT00843934|"~     The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and~     epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular~     Carcinoma (HCC).~   "
207591|NCT00843921|"~     This study is based on the hypothesis that a new drug N-carbamylglutamate (Carbaglu®) will~     enhance the ability of the liver to dispose of toxic ammonia which accumulates in several~     metabolic diseases including urea cycle disorders and organic acid disorders.~   "
207615|NCT00843583|"~     This study aims to investigate the prevalence of obstructive sleep apnea (OSA) in subjects~     with resistant hypertension and to evaluate the relationship between parameters of OSA~     severity and blood pressure control~   "
207662|NCT00842959|"~     It is planned to implant the intraocular lenses XL Stabi ZO and Invent ZO into the eyes of~     patients for whom a cataract operation is medically indicated. The lenses are marketed and CE~     certified. Their implantation is clinical routine.~      In the trial the accuracy of prediction of target refraction and the difference between~     calculated and measured contrast vision will be examined for both lens types.~   "
214867|NCT00747188|"~     The present study aimed to compare the effect of education through problem-based learning~     (PBL) or lectures on behavior, attitude and learning of nursing students.~   "
207592|NCT00843908|"~     The aim of this study is to assess whether the Miniarc suburethral sling is equivalent to the~     TVT in the treatment of women with urodynamic stress incontinence (USI). If equivalence is~     proven, the advantages to women with USI will be potentially significant since the Miniarc~     may be carried out as an office based procedure, negating the need for an anaesthetic and~     hospital admission. The investigators null hypothesis is that there is no difference in~     subjective or objective outcome between the TVT and the Miniarc in the treatment of USI.~      Eligible women will be initially assessed with a full history and examination, King's Health~     Questionnaire and twin channel subtraction cystometry. They will be randomised (using a~     series of numbered opaque envelopes) to undergo either the TVT or Miniarc. Follow up will be~     at 6 weeks, with a subjective outcome measure and at 6 months with a repeat subjective~     assessment and repeat twin channel cystometry.~   "
207593|NCT00843895|"~     The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine~     antibiotic susceptibility.~   "
207594|NCT00843882|"~     This randomized phase III trial studies lenalidomide to see how well it works with or without~     epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may~     stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony~     stimulating factors, such as epoetin alfa, may increase the number of immune cells found in~     bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective~     with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.~   "
207595|NCT00843869|"~     This study is focused on identifying the prevalence of passive or active smoke exposure and~     zinc deficiency in a cohort of patients who meet the objective and subjective guidelines for~     chronic rhinosinusitis set forth by the Sinus and Allergy Health Partnership.~   "
207596|NCT00843856|"~     Membranous nephropathy is a common cause of nephrotic syndrome in adults. It is difficult to~     treat and if persistent leads to end stage renal failure in a significant number of patients.~     It is currently treated in this institution with tacrolimus monotherapy. This is effective in~     the majority of patients in reducing proteinuria but the remissions are often partial and~     patients tend to relapse when the tacrolimus treatment is stopped. We propose to use~     mycophenolate mofetil in combination with tacrolimus with the aim of obtaining a more~     complete initial response to treatment, a decreased rate of relapse on withdrawal of therapy~     and less progression of renal failure. This will be a randomised control trial, patients will~     be randomised to receive treatment with tacrolimus alone (our current standard therapy)or~     treatment with tacrolimus and mycophenolate mofetil. Participants will receive treatment for~     up to 2 years and then be monitored for relapse of their nephrotic syndrome.~      Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of~     membranous glomerulonephritis it is likely to improve the initial response to treatment and~     reduce the risk of relapse on stopping therapy.~   "
207597|NCT00843843|"~     This research will examine why sleep restriction reduces the body clock's response to bright~     light. The results will enable the optimization of the bright light treatment of people who~     suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet~     lag, delayed sleep phase syndrome and winter depression, thereby improving public health and~     safety, well-being, mood, mental function, and quality of life.~   "
207598|NCT00843830|"~     This study is being done to determine whether it is possible to use an investigational~     vaccine that consists of dendritic cells in patients with pancreas cancer. Dendritic cells~     are immune cells that are obtained from your blood that are important in the body's immune~     response to foreign substances. The vaccine would be injected directly into a tumor that has~     spread to the liver after a short course of radiation therapy has been given to that tumor.~     The study will try to determine if this treatment would be safe and effective in treating~     this cancer.~      This is a phase 1 pilot study of this treatment. Phase 1 trials test the best way to give a~     treatment where little is known about its possible risks or benefits. Phase 2 studies then~     test the possible benefits of a treatment and may show the specific situations where they are~     seen. Promising treatments are then tested in Phase 3 trials which compare the new treatment~     to standard treatment in a larger group of patients. Phase 4 trials are those conducted on a~     treatment after it has been approved for general use outside of research. A pilot study tests~     a treatment in a small number of patients to learn if and how the treatment could be tested~     in a larger group. Pilot studies can be performed at any phase but are commonly performed in~     the earliest phases of research on a treatment.~   "
207599|NCT00843817|"~     Serine proteases belonging to the elastase family are mainly responsible for lung tissue~     destruction as observed during cystic fibrosis. But anti-inflammatory therapies based on~     systemic or aerosolized protease-inhibitors administration, have not given the expected~     results until now. One reason would be the impaired access of therapeutic inhibitors to their~     molecular targets. It was recently shown that neutrophils actively secrete neutrophil~     extracellular traps (NETs) made of DNA that binds cationic proteases among other molecules.~     NETs together with DNA passively released from dead neutrophils contribute to the viscosity~     of CF expectorations which explains that rhDNase treatment fluidifies expectorations and~     improves the patient status. Preliminary experiments in our laboratory have shown that DNA~     degradation was associated with a significant increase of proteolytic activity in the sputum~     soluble fraction. However the efficacy of exogenous inhibitors is also improved in these~     conditions. Using the specific substrates and methodologies that we developed previously to~     measure cell-surface associated proteolytic activities, we will study the effects of DNase on~     the activity of individual proteases, their biodistribution in sputum and their regulation by~     potential therapeutic inhibitors. Enzymatic, immunochemical and microscopic (confocal and~     scanning) techniques will first be used for ex vivo studies on sputa freshly collected at the~     adult and paediatric CRCM in Tours, then on sputa from patients before and after~     administration of aerosolized rhDNase. We hypothesize that a better understanding of the~     biodistribution of neutrophil serine proteases and especially their binding to DNA will help~     designing new therapeutic strategies that facilitate inhibitor access to their protease~     targets.~   "
207600|NCT00843804|"~     The Oncoped 2006 study implements a multicenter prospective surveillance module for~     nosocomial infections in pediatric cancer patients.~   "
207601|NCT00843791|"~     The purpose of this study is to learn more about how insulin resistance (inability to process~     glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.~   "
207604|NCT00843739|"~     Respiratory difficulty is one of the primary factors leading to death in patients with~     Idiopathic Parkinson's Disease (IPD). The progressive degeneration of a family of segregated~     motor and non-motor circuits in the brain results in motor and non-motor dysfunction.~     Breathing and swallowing are well known to be affected in IPD, and attention to these~     functions is fitting since most patients eventually experience morbidity and even mortality~     as a result of this dysfunction. Patients with IPD typically become sedentary and lose~     endurance, maximal fitness levels and overall pulmonary function. Much of the research focus~     has been on the motor symptoms of IPD (tremor, rigidity, bradykinesia) yet the pulmonary~     complications are perhaps ultimately the most important disability. The inability to generate~     adequate respiratory pressure is responsible for reduced cough magnitudes and cough response~     times. Cough is critical for the clearance of foreign materials in the airway helping to~     reduce infiltration of bacteria and subsequent respiratory infection. With reduced cough~     function an increased risk for pulmonary disease due to a reduced ability to protect the~     airways occurs. Moreover, the recognized debilitating disruptions to voice and speech~     characteristics that limit communication, care taking, employment opportunities and social~     interactions are also a result of poor respiratory function. There are a number of promising~     outcomes from an expiratory strength-training program. By increasing expiratory muscle~     strength and expiratory pressure generation, effective breathing, clearance of the airway,~     production of a louder and clearer voice as well as improved swallowing can occur. These~     explicit outcomes are predicted based on our experience with the use of an innovative~     device-driven, home-based expiratory strength training program focused on the expiratory~     muscles of respiration.~      The aims of this study are to: 1) Investigate the activity of expiratory muscle strength~     training (EMT) in patients with idiopathic Parkinson's disease (IPD), 2) Determine the effect~     of increased expiratory force generation on breathing, cough magnitude, speech production,~     and swallowing, 3) Determine the effect of increased expiratory force generation on the~     patient's perception of speech change, 4) Determine the effect of Dopamine-replacement~     therapy (Parkinson's medications) on breathing, coughing, speaking, and swallowing measures.~   "
207605|NCT00843726|"~     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation~     therapy is more effective in treating patients with non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy~     regimens and to see how well they work in treating patients with stage I or stage II~     non-small cell lung cancer.~   "
207606|NCT00843713|"~     Recent studies suggest that HIV patients are at increased risk for cardiovascular events;~     however, the mechanisms underlying this increased risk remain unclear. Our group was one of~     the first to demonstrate that HIV infection is independently associated with accelerated~     atherosclerosis, as measured by carotid artery-intima media thickness (IMT), and that~     HIV-associated inflammation may be driving this accelerated atherosclerosis. The mechanism by~     which HIV disease independent of any drug-specific toxicity increases the risk of~     cardiovascular disease during HAART is not known. We hypothesize that even well controlled~     HIV infection is independently associated with cardiovascular risk and that further~     decreasing HIV-associated inflammation adding newer antiretroviral agents will also decrease~     cardiovascular risk.~      We will perform a small clinical trial of approximately 50 HIV-infected patients each to~     study the relationship between HIV infection, inflammation, thrombosis, atherogenic~     lipoproteins, and measures of atherosclerosis. We propose the following specific aims: Aim 1:~     To determine the influence of traditional and novel markers of inflammation on endothelial~     function and IMT progression; Aim 2: To determine if intensification with raltegravir in~     subjects on long-term antiretroviral therapy with clinically undetectable HIV RNA levels will~     improve endothelial function, and to determine if this effect is mediated by alterations in~     inflammatory markers, lipoproteins and/or thrombotic factors. For Aim 2, subjects from 2~     randomized, double-blind, placebo-controlled raltegravir intensification studies will be~     asked to co-enroll in this cardiovascular study.~   "
207607|NCT00843700|"~     The aim of the Women's Depression Treatment Study, based in a community mental health center,~     is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings~     (IPT-TCS) on improving depression and other psychological and social functioning. IPT-TCS is~     Interpersonal Psychotherapy with modifications specifically designed for the treatment of~     depressed patients with trauma histories seen in community settings.~   "
207608|NCT00843687|"~     The purpose of this study is to compare the pharmacokinetics and safety of long-acting~     injectable risperidone, an atypical antipsychotic medication used for the treatment of~     patients with schizophrenia, when it is administered as an intramuscular injection via the~     deltoid muscle, compared with intramuscular injection via the gluteal muscle.~   "
207609|NCT00843661|"~     -  The aim of the study is to compare the effects of coadministration of ezetimibe 10~          mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected~          patients treated with protease inhibitors.~        -  Single-centre, open, randomized, controlled, prospective pilot study.~        -  60 patients will be enrolled in order to reach the target of 50 patients evaluable at~          the end of the study. The patients will be randomly assigned to a 6-month treatment with~          ezetimibe+fenofibrate or with pravastatin.The visit will be every month.~   "
207610|NCT00843648|"~     The immune system is a dynamic, constantly evolving network. Excluding autoimmune diseases,~     healthy individuals are also known to have a large number of circulating antibodies that can~     recognize proteins of their own tissues. These antibodies are known as natural antibodies and~     previous studies suggested that some features of these self components are shared by~     individuals in certain physiological states. Thus, monitoring self immunoglobulins can~     provide an overview of the various states of the immune system. To do so, and in the process~     to obtain systems biology view of the immune system, the newly developed Antigen Chip~     technology has been used.~      To further investigate this subject we plan to carry out broader investigations that will be~     conducted in collaboration with the group of Prof. Eshel Ben-Jacob from the university of~     Tel-Aviv and Prof. Irun Cohen from the Weizmann Institute that have the required experimental~     and analytical expertise and facilities. The studies will include follow-up on the immune~     state of babies and their mothers for several months post birth using the Antigen Chip and~     analyzed by the Immune holography method. The investigations will also include comparative~     studies between the immune signature of different body fluids, the effects of feeding, and~     the effect method and time of labor.~   "
207611|NCT00843635|"~     RATIONALE: Biological therapies, such as tadalafil, may stimulate the immune system in~     different ways and stop tumor cells from growing.~      PURPOSE: This randomized clinical trial is studying how well tadalafil works in treating~     patients who are undergoing surgery for cancer of the oral cavity or oropharynx.~   "
207612|NCT00843622|"~     The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for~     oral use (snus) can increase the quit rate among cigarette smokers who wish to stop smoking~   "
207721|NCT00842179|"~     The objective of this study is to compare groin complication rates in low and high risk~     patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose~     vascular closure device (VCD) or manual compression.~   "
207616|NCT00843570|"~     Frozen Embryo Replacement (FER)is a fertility treatment by which stored embryos from a fresh~     IVF treatment cycle are thawed and transferred into the uterus. Frozen embryos can be~     replaced either in the middle of a natural menstrual cycle (Natural FER) or in a cycle where~     the woman takes drugs to suppress her own hormones, and then takes Hormone Replacement~     Therapy (HRT) to prepare her uterus for the transfer of embryos(HRT − FER).~      Both are widely used methods of fertility treatment. However, to date no well designed~     studies have been reported in which the two methods have been compared. This study aims to~     compare the two treatments in order to establish the best treatment protocol.~      The study design is a single centre open randomized controlled trial funded by the Oxford~     Fertility Unit.~      100 women who are considering FER treatment at the Oxford Fertility Unit and are eligible for~     the study will be recruited.~      After giving their written consent they will be randomised to one of 2 groups: Natural FER~     and HRT FER.~      Patients in both groups will be asked to attend one initial visit, which is additional to~     patients not taking part in the study.~      Subsequent visits will depend on the treatment group but will not be additional for study~     participants. All visits requiring ultrasound will involve recording 3−D measurements, which~     increases the length of each visit by approximately 10 minutes. A patient satisfaction~     questionnaire would be completed at the end of the cycle.~      A urinary pregnancy test is performed at home 2 weeks following the embryo transfer visit. If~     this is positive then further visits to the unit are arranged to confirm the clinical~     pregnancy.~      Inclusion in the study would not increase the length of time of either treatment cycle.~     Follow up would extend to obtaining pregnancy outcome information.~   "
207617|NCT00843557|"~     The purpose of this study is to better understand the relationship between gender (being a~     man or a woman), infections caught in the hospital, and serious illness. Five hundred seventy~     patients 18 years of age or older who are critically (seriously) ill and admitted to the~     Intensive Care Unit (ICU) for at least 48 hours will participate in this study. Patients will~     be studied while receiving regular ICU treatment according to local standards. Blood~     specimens will come from patients either as wasted blood (University of Virginia) or blood~     collected from patients specifically for the study (Vanderbilt University). All patients will~     be followed daily until death or discharge from the ICU. The researchers believe that they~     will find a similar risk of infection for men and women overall.~   "
207618|NCT00843544|"~     The overall aim of this research project is to test the effectiveness of an integrative~     program, using journaling, yoga breathing instruction, and nutritional manipulation and~     supplementation, on quality of life and clinical outcomes in adults with asthma. An~     additional aim is to determine whether an integrative approach to asthma management leads to~     cost savings when compared to standard clinical care.Patients will be randomly assigned to~     either the intervention condition or a waitlist control condition. For the intervention~     group, all measures will be obtained at baseline, immediately after the treatment protocol is~     completed, and then at three month and six month intervals after the completion of the~     intervention. For the control group, data will be collected at the same times as the~     intervention group, with one exception: data collected at the completion of the treatment~     protocol will be replaced with data collection at six weeks post-baseline for the control~     group. Data will be collected using measures of quality of life (Asthma Quality of Life~     Questionnaire and SF-12), pulmonary function and health care utilization and expenditures.~      Participants assigned to the treatment group will begin in groups of ten. The treatment~     protocol will consist of six 1-2 hour sessions over a six-week period as follows:~        1. Subjects will attend a two-session class on healthy eating focused on reducing~          inflammation-promoting foods in the diet. All subjects will also be started on fish oil~          and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract~          from hops and rosemary with anti-inflammatory action. Supplements willl be provided free~          of charge. Subjects will be provided with a take home supply to begin using.~        2. Subjects will attend two classes at CCHH in yoga breathing techniques and will then be~          provided with a CD for home study and practice~        3. Subjects will attend two guided journaling sessions at CCHH in which subjects will be~          asked to write for a 30-minute period about the most traumatic or stressful life~          experience to date.~   "
207619|NCT00843531|"~     The purpose of this study is to test how safe and effective the combination of RAD001 and~     erlotinib is in patients with neuroendocrine tumors.~   "
207620|NCT00843518|"~     The purpose of this study is to determine whether this drug can help symptoms of aggression~     and agitation in participants with Alzheimer's disease.~   "
207621|NCT00843505|"~     People who smoke cigarettes and live in rural areas may not have access to a wide variety of~     resources to help them stop smoking. This study will evaluate two smoking cessation~     programs—an Internet-based telemedicine program and a telephone-based quitline program—among~     rural residents.~   "
207622|NCT00843492|"~     The purpose of this study is to evaluate the efficacy and safety of fondaparinux in~     comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the~     leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood~     clots that migrate to the lungs) in patients with leg injuries below the knee that require a~     cast or other type of immobilization but not surgery.~   "
207623|NCT00843479|"~     Like most endocrine axes, the entero-insular axis is expected to go through an age-related~     physiological deterioration, what might contribute to special features of the elderly onset~     type 2 diabetes in comparison to middle-age.~      Twenty four NGT volunteers will be evaluated by a meal tolerance test (MTT) for incretin~     hormone measurements, and by the hyperglycemic clamp followed by an arginine test for~     assessing the beta-cell function and the acute insulin response. Others parameters as body~     composition and basic biochemistry will be also evaluated at Laboratory of Investigation on~     Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.~      The characterization of the glucagon-like peptide-1 (GLP-1) production, dipeptidyl peptidase~     IV (DPP-IV) activity and/or endocrine pancreas incretin-response at aging, might be an~     interesting evidence to reinforce an incretin-based therapeutic approach for elderly onset~     type 2 diabetes.~   "
207624|NCT00843466|"~     The purpose of this study is to find out if the use of a hand cleanser that adds moisture to~     the skin will help improve skin rashes caused by frequent hand washing (hand dermatitis).~   "
207625|NCT00843453|"~     This study was designed to determine whether elderly residents of long term care facilitated~     who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to~     have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal~     spray improved these subjects' vitamin B12 status.~   "
207626|NCT00843440|"~     The efficacy of anti-VEGF treatments such as Bevacizumab in cases of HHT can be considered~     because of the molecular mechanisms implied in angiogenesis and HHT, as well as the~     mechanisms of action of this type of treatment. Two articles that have recently reported~     spectacular improvement thanks to Bevacizumab in patients with HHT complicated with severe~     liver involvement and cardiac effects support us in this sense.~      Up to now, the only treatment recommended in the severe hepatic forms of HHT is a liver~     transplant, the disadvantages of which are both multiple and well known: long waiting lists,~     surgical morbidity and mortality, immunosuppressive treatment for life. Furthermore,~     treatment with Bevacizumab is not a contraindication, should the drug be ineffective, for a~     subsequent liver transplant if necessary.~   "
207627|NCT00843427|"~     The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy.~   "
214011|NCT00758576|"~     The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal~     Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens~     following cataract removal.~   "
207629|NCT00843401|"~     The general purpose of this study is to evaluate the feasibility, accuracy and performance of~     the Nellcor/Covidian 600-x and the Masimo rainbow technologypediatric and neonatal oximetry~     sensors over clinically relevant ranges of arterial saturations between 60-100%.~      The study objectives are as follows:~        1. To evaluate the accuracy of a neonatal sensor in the saturation range of 70-80% in the~          following weight category: 0-5kg.~        2. To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand)~          sensors in the saturation range of 60-80% in the following weight categories: 0-5kg;~          and, 5-40kg.~        3. To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand)~          sensors in the saturation range of 80-100% in the following weight ranges: 0-5kg; and,~          5-40kg.~   "
207630|NCT00843388|"~     A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age~     18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days~     treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during~     hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin,~     angiotensin, aldosteron.~   "
207631|NCT00843375|"~     Colonoscopy is the current state-of-the-art screening procedure for detecting colorectal~     cancers. However, compliance with this screening procedure by the public is very low for a~     variety of reasons. New screening tools are needed to improve detection of colon cancer.~     Biomarkers from stool, urine, serum, tissue and plasma may provide valuable initial screening~     tools to sort the population into those that need colonoscopy and those that most likely do~     not. This is a cross-sectional study of subjects undergoing clinically-indicated colonoscopy~     or who have diagnosed colorectal cancer who are willing to provide biospecimens.~   "
207632|NCT00843362|"~     The aim of induction of labour is to initiate labour when maternal and fetal conditions~     necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely~     used for induction of labour, and can be administered orally, vaginally, intracervically,~     endovenously and by extra-amniotic or intra-amniotic routes. Dinoprostone is one of the~     synthetic prostaglandins most commonly used to achieve cervical ripening and labour~     induction, and can be administered as tablets, suppositories, gel (vaginal and intracervical)~     or as a controlled-release intravaginal pessary. The controlled-release pessary has some~     potential advantages: a single application is required; the insert is easily administered and~     can be removed as soon as labour starts or if complications ensue. Studies comparing the~     dinoprostone vaginal insert to other prostaglandin formulations have shown variable results,~     probably influenced by drug administration regimens, indications for induction, and cervical~     conditions of the women. The purpose of this study is to assess the efficacy of the induction~     of labour using dinoprostone in patients with an unfavourable cervix, and to compare the~     efficacy and the cost of 24-hours controlled-release dinoprostone pessary and intravaginal~     dinoprostone gel.~   "
207633|NCT00843349|"~     The investigators would like to study the role of phosphorus metabolism in the development of~     certain hormonal problems in people with chronic kidney disease (CKD). More specifically, the~     goals of the research are (1) to understand the cause of hyperparathyroidism - a hormone~     problem that often develops in patients who have kidney disease and (2) to test whether~     decreasing phosphorus intake could help improve or prevent hyperparathyroidism.~   "
207634|NCT00843336|"~     The purpose of this research study is to compare the effectiveness of two natural family~     planning (NFP) methods that are provided over the internet by the Marquette University~     Institute for Natural Family Planning. One of the NFP methods is the use of a hand held~     electronic hormonal fertility monitor. The other method involves the self-observation of~     cervical mucus to track fertility. Both of the methods will involve placing information about~     fertility into an online charting system that automatically displays the days of fertility~     and infertility. The investigators are also interested in the influence of mutual motivation~     by the woman and her partner in using these methods to avoid pregnancy. The investigators~     hypothesize that there will be lower unintended pregnancy rates among those couples who use~     the electronic hormonal fertility monitor and among those couples who have a strong~     motivation to avoid pregnancy.~   "
207635|NCT00843323|"~     In this study, 26 patients were selected and included for full-face photodynamic therapy~     sessions. All patients presented signs of photoaging skin and multiple actinic keratosis.~     Photographs and Biopsies were taken before and after the procedure. Clinical and histological~     aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor~     expression were evaluated.~   "
207636|NCT00843310|"~     This study is to determine whether addition of Revlimid to standard therapy will increase~     overall and complete response rates compared to historical standard frontline therapy and~     whether this combination treatment has fewer side effects than similar combination induction~     treatment.~   "
207637|NCT00843297|"~     Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive~     deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH)~     lowers mortality and reduces neurologic damage after cardiac arrest. The investigators~     evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of~     patients after SCA.~   "
207638|NCT00843284|"~     A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to~     assess the impact of pregabalin on subjects' pain, quality of sleep, and their general~     wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic~     pain.~   "
207639|NCT00843271|"~     The purpose of MESA-Lung is to assess the role of endothelial dysfunction and genetic~     susceptibility in subclinical COPD.~   "
207663|NCT00842946|"~     The purpose of this study is to compare two exposure-based behavioral group treatments for~     public speaking anxiety. Specifically, exposure within the context of psychological~     acceptance will be compared to exposure within a standard habituation context. It is~     hypothesized that participants receiving exposure within the context of psychological~     acceptance will experience a greater decrease in anxiety and greater improvement in quality~     of life compared to the habituation-based group.~   "
207664|NCT00842933|"~     Randomized controlled trial evaluating the duration of steroid replacement therapy in~     patients with adrenal insufficiency and septic shock. Patients will be randomized to receive~     either hydrocortisone 50 mg IV every six hours for seven days (control) or hydrocortisone 50~     mg IV every six hours until 24 hours after achievement of hemodynamic stability (MAP > 65 mm~     Hg off of vasopressors).~   "
207640|NCT00843258|"~     Developmental dysplasia of the hip is the most common musculoskeletal disorder in infancy,~     with a reported prevalence of 2% of all newborns. Although newborn screening programs based~     on clinical examination with Ortolani and Barlow tests were introduced in the 1950's and~     1960's with early abduction splinting of the 2% testing positive, the prevalence of late~     cases warranting surgery has remained stable, around one per 1000. This has led to the~     introduction of ultrasound as an additional diagnostic tool, resulting in treatment rates of~     until 5-6%. This three fold increase in abduction splinting treatment is partly due to the~     initiation of treatment of infants in whom mild hip dysplasia but no hip instability has been~     identified. The benefit of early treatment of mild dysplasia in a hip that is neither~     dislocated nor dislocatable is unclear. Further, abduction splinting is not without risk,~     with avascular necrosis being reported in around 1%. The investigators conducted a masked,~     randomized, controlled trial to examine whether mildly dysplastic but stable or instable hips~     would benefit from early treatment, as compared to watchful waiting.~   "
207641|NCT00843245|"~     The purpose of this study is to determine how electrical impedance is modified in relation to~     extracellular space body fluid retention detected by an electrical bioimpedance method in~     patients with heart failure.~   "
207642|NCT00843232|"~     Type 2 diabetes (T2DM) is characterized by hyperglycemia, insulin resistance, absolute or~     relative insulin deficiency, hyperglucagonemia, increased hepatic glucose production,~     frequently accelerated gastric emptying and obesity. The known effects of the incretin~     hormone glucagon-like peptide-1 (GLP-1) on the metabolism are stimulation of insulin~     secretion, inhibition of glucagon secretion and hepatic glucose production, reduction in~     gastric emptying and modulation of the appetite. T2DM have disturbances in this system,~     providing a rationale for therapeutic use of GLP-1 in T2DM. Furthermore, GLP-1 seems to exert~     trophic effects on the beta-cell.~      Dipeptidyl Peptidase IV (DPP-IV) inhibitors represent a new class of oral anti-hyperglycemic~     agents for the treatment of T2DM. The therapeutic utility of these antihyperglycemic agents~     rests on their ability of to increase active (intact) levels of incretin peptides, including~     GLP-1 and GIP.~      Twenty four T2DM volunteers will be evaluated by a meal tolerance test (MTT) for incretin~     hormone measurements, and by the hyperglycemic clamp followed by an arginine test for~     assessing the beta-cell function and the acute insulin response. Others parameters as body~     composition and basic biochemistry will be also evaluated at Laboratory of Investigation on~     Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.~      T2DM in elderly are behaving differently. Elderly patients have no increase in liver~     production of glucose; when obese, have normal insulin secretion, however, display extreme~     resistance to its action. In non obese individuals, the concentration of glucose necessary~     for insulin secretion is increased and the action is standard. These findings suggest~     therefore that the approach should be differentiated treatment for these individuals.~   "
207643|NCT00843219|"~     Objectives:~      Evaluation of an amplitude based gated Positron Emission Tomography (PET) data acquisition~     system for all GE Discovery Positron Emission Tomography/ Computed Tomography (PET/CT)~     scanners.~   "
207644|NCT00843193|"~     Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study~   "
207645|NCT00843180|"~     Undergoing bone marrow transplantation (BMT) is associated with a high level of distress for~     patients and caregivers. Clinical research studies have reported benefits from massage for a)~     oncology patients, b) children, c) adults and children undergoing bone marrow transplants. A~     multi-center study of an intervention using a combination of massage therapy and a laugh cart~     to reduce distress in pediatric oncology patients undergoing BMT (PI: Phipps) is completed~     with results not yet published. There is still a need for independent studies to isolate the~     effect of massage for clinical outcomes (such as improved nausea and pain control) in~     children. Furthermore, this study will test the acceptability of an augmented massage~     intervention. In addition to provider-child massage, the augmented massage intervention~     includes training of the resident parent to provide additional parent-child massage, to~     relieve symptoms as needed. The goal of this augmented intervention is the improvement of~     symptom management in patients and decreased stress and feelings of helplessness in parents.~      We propose a randomized pilot study at the UCSF pediatric bone marrow transplant center to~     assess the feasibility of a higher-quality study of the effects of massage in this~     population.~      Aim 1: Determine the acceptability of a massage intervention for patients and parents on a~     pediatric bone marrow transplant unit.~      Aim 2: Explore the logistics of implementing the augmented massage intervention at the~     bedside offered to consecutive patients over one year's time.~      Aim 3: Collect preliminary data for patients and parents including patient clinical outcomes,~     quality of life, and satisfaction, and parental stress and mood to allow sample size~     calculations for further studies.~   "
207646|NCT00843167|"~     RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal~     cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal~     hyperplasia.~      PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in~     treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical~     ductal hyperplasia.~   "
207647|NCT00843154|"~     The purpose of this study is to determine the effects of Candesartan, once daily (QD), added~     to ongoing chronic heart disease therapy in measuring brain natriuretic peptide in patients~     with chronic heart failure.~   "
207648|NCT00843141|"~     The study group of Adults with ADHD who will receive cognitive (executive attention)~     computerized training will show significant improvement in ADHD~     symptomatology,neuropsychological measures,daily functioning and quality of life.~      A significant difference will be found between the study group and the control group (adults~     with ADHD that will receive a simplified cognitive training program that does not challenge~     their executive functions)on the above measures.~   "
207665|NCT00842920|"~     Probands with MCI are at high risk to develop Alzheimer´s dementia (AD). Simvastatin may~     lower the production of Amyloid, a hallmark of AD in the brain. The primary hypothesis of the~     study is that 60 mg Simvastatin significantly reduces the Clinical Dementia Rating -Sum of~     boxes (CDR-SOB) in individuals with MCI as compared to MCI receiving placebo or 20 mg~     Simvastatin~   "
207740|NCT00841919|"~     The purpose of this study is to determine if by using insulin analog (Glargine and lispro~     insulin) with an insulin pen the investigators are able to obtain a higher rate of correct~     timing of insulin and food administration as when compared to the usual therapy (insulin NPH~     and regular) with syringes.~   "
207649|NCT00843128|"~     Objective: To evaluate the efficacy of robot-assisted gait training (RAGT) in MS patients~     with severe walking disabilities (Expanded Disability Status Scale [EDSS] 5.5-7) as compared~     to regular physiotherapy.~      Methods: Prospective, randomized, controlled clinical trial comparing RAGT with conventional~     walking training (CWT) in a group of stable MS patients (n=40) during an outpatient~     rehabilitation program. Inclusion criteria are chronic or secondary progressive MS patients~     with EDSS between 5.5-7, stable treatment 3 months before study entry, without generalized~     diseases. All patients will sign an informed consent. Following randomization, 20 patients~     will be treated with RAGT, 12 sessions over three weeks. The control group will be treated by~     CWT, 12 sessions in three weeks. The primary outcome measures will be the Functional~     Ambulatory Capacity (FAC) scale and the 6-minutes walking distance. The secondary outcome~     measures will be the Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS~     score, FIM score and RAND questioner for quality of life. All tests will be performed by an~     external blinded assessor at baseline, after three weeks, and at follow-up after 3 months and~     six months.~      Importance: We anticipated that Robot-assisted gait training will be found as feasible and~     may be an effective therapeutic option in MS patients with severe walking disabilities.~   "
207650|NCT00843115|"~     To characterize the comorbidities and medications of patients treated with donepezil in a~     routine clinical practice and to verify the therapeutic response of these patients.~   "
207651|NCT00843102|"~     Aim: Determination of frequency and nature of coronary involvement (including epicardial and~     microvascular) among scleroderma patients referred for right heart catheterization.~   "
207652|NCT00843089|"~     Despite immediate symptomatic success after coronary bypass surgery in patients with coronary~     artery disease, this effect is not sustained over time since risk factors for coronary artery~     disease are still in place. The role of secondary prevention becomes increasingly important~     as it can potentially decrease or eliminate the need for another intervention in these high~     risk subjects. This project seeks to evaluate the effect of emphasizing secondary prevention~     measures in this patient population during hospital admission and through six months~     post-discharge.~   "
207653|NCT00843076|"~     Chronic infection by the hepatitis C virus (HCV) is a common cause of liver disease, which~     may progress to cirrhosis and eventually liver cancer. The therapeutic indication will depend~     mainly on the importance of liver damage (fibrosis), which can be assessed by physical~     techniques, blood tests and a liver biopsy. The overall objectives of the project are to~     understand how HCV variability may influence the severity of steatosis (accumulation of fat~     in the liver), studying 30 patients chronically infected with HCV (half of these patients~     infected by HCV genotype 3, versus the other half infected by HCV of another genotype). A~     small portion of the biopsy performed for the routine pathology examination will be placed in~     special fixation buffer for electron microscopy (EM). Counting and measuring the size of~     lipid droplets present in the liver by EM will be used to precisely quantify and characterize~     the liver steatosis. A blood sample of patients will also be collected to sequence the viral~     genome present in the patient and identify the amino acids involved in an increase in~     intracellular accumulation of lipid droplets. This work should clarify the impact of the~     viral variability in the severity of steatosis. Ultimately, the identification of viral~     sequences responsible for an increase of this phenomenon could be crucial for understanding~     the mechanisms involved in the steatosis.~   "
207654|NCT00843063|"~     Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with~     symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal~     side effects.~      The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer~     or erosions by proton pump inhibitor is unclear.~      The objective of this randomized, double blinded control study was to compare the efficacy of~     high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or~     complicated ulcer/ erosions in patients taking low-dose aspirin~   "
207655|NCT00843050|"~     The purpose of this study is to determine whether P276-00 is safe and effective in treatment~     of Mantle Cell Lymphoma that is recurred after or not responding to at least one previous~     line of treatment.~   "
207656|NCT00843037|"~     This is an open-label phase II study of an investigational drug, sunitinib malate in patients~     with advanced malignant paraganglioma or phaeochromocytoma cancer. Paragangliomas (PGs) are~     tumours that arise from the para-sympathetic system in the head and neck and sympathetic~     system in the thorax and abdomen. Paragangliomas that secrete hormones (catecholamines) from~     the adrenal glands are called pheochromocytomas (PCs). In this study, patients whose disease~     has advanced or spread despite prior standard therapy, will receive sunitinib for 4-weeks~     followed by a 2-week rest period, for up to 12 months, in the absence of disease progression.~     Sunitinib is an investigational drug, which has been shown to shrink tumours in several~     tumour models. The study will evaluate the efficacy as well as the toxicity profile of~     sunitinib when used as an alternative treatment for patients with PG/PC tumours.~   "
207657|NCT00843024|"~     This study was designed to determine how well the combination medication, sumatriptan and~     naproxen sodium, treats migraine headache in adolescents 12-17 years old~   "
207658|NCT00843011|"~     This study is an open-label, randomised, single dose study to determine the pharmacokinetics,~     safety and tolerability of 2 different formulations of orvepitant 60 mg and the effect of~     food in 15 Healthy Volunteers.~   "
207659|NCT00842998|"~     This study will evaluate the activity of single agent trastuzumab or lapatinib in patients~     not previously treated for HER-2 positive (FISH positive) metastatic breast cancer. A~     companion biological study will assess factors correlated with sensitivity or resistance to~     either one of the compounds~   "
207660|NCT00842985|"~     Marijuana use is a major problem among veterans and non-veterans. A patient's use of~     marijuana while engaged in psychotherapy treatment may affect their memory and, therefore,~     limit their ability to benefit from treatment. This study is designed to test a new~     pharmacotherapy, modafinil, which has the potential to improve memory functioning in~     marijuana using individuals.~      We hypothesize that modafinil treatment will decrease ratings of drug liking and improve~     cognitive measures, especially episodic memory.~   "
207661|NCT00842972|"~     This study was conducted to evaluate the effect of A1C variability on the progression of~     carotid artery intima-media thickness in type 2 diabetic patients.~   "
207666|NCT00842907|"~     This is a randomized, comparative, single evaluator-blinded trial to evaluate clinical,~     histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen~     as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen for the treatment~     of photodamage on face and forearms. Main oral isotretinoin safety parameters will also be~     analyzed, as well as adverse events related to topical products.~   "
207667|NCT00842894|"~     This study is conducted in Europe. The aim of this observational study is to investigate the~     incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart~     30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal~     clinical practice conditions in Macedonia.~   "
207668|NCT00842881|"~     The purpose of this study is to determine whether Healing stone navel belt is safe and~     effective in the treatment of Primary Dysmenorrhea.~   "
207669|NCT00842868|"~     The purpose of this research is to determine the relationship between novel blood tests for~     heart function (including hormones and heart enzymes measured in the blood), and assess for~     kidney damage before and after angiography (cardiac catheterization). We hypothesize that~     these novel tests will enable us to predict possible complications of catheterization~     immediately after the procedure.~   "
207670|NCT00842855|"~     The purpose of this study is to describe common treatment pathways, to collect health care~     utilization data and to assess symptom load as well as impact of symptoms on daily life in~     GERD patients who are partial-responders to PPI treatment.~   "
207671|NCT00842842|"~     The purpose of this study is to determine whether mesh fixation in laparoscopic umbilical~     hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and~     recovery.~   "
207672|NCT00842829|"~     Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal~     Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving~     maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually~     titrated to an effective dose that provides adequate analgesia and minimizes undesirable~     effects. To reach the safest effective dose for the individual patient as soon as possible,~     the dose titration process is critical. The aim of this study, conducted under pragmatic~     conditions in a large-scale population of cancer patients is to compare the proportion of~     patients reaching an effective FBT dose after titration starting with either a 100 mcg dose~     or a 200 mcg dose.~   "
207673|NCT00842816|"~     This study will investigate the ability of ST101 to improve memory in people with Alzheimer's~     disease who currently receive 10 mg Aricept® (donepezil) per day. This study also will~     examine the safety and tolerability of the drug. This study is evaluating 3 different dose~     levels of ST101 and placebo. Patients will have a 1 in 4 chance of getting placebo. All~     eligible subjects will be provided with bottles of 10 mg Aricept (donepezil) during the study~     drug administration part of the study.~   "
207674|NCT00842803|"~     The purpose of the study is to examine if outcome after liver transplantation is improved by~     using albumin infusion post-transplantation.~   "
207675|NCT00842790|"~     The goal is to study the impact of functional MRI and CT evaluation of changes in tumor~     vessels induced by anti-angiogenic treatment in patients with metastatic RCC.~      The hypothesis is that good responders and poor responders will have different responses~     induced by anti-angiogenic treatment, and that the detection of theses changes by functional~     imaging can improve the therapeutic management.~      Functional CT and MRI will be performed in 200 patients before the beginning of~     antiangiogenic treatment, 7 days after and every 6 week until tumor progression (as defined~     by the RECIST criteria). Perfusion and diffusion parameters will be measured using a~     dedicated software.~   "
207676|NCT00842777|"~     Long term effects of treatment of childhood obesity are not well documented but there is~     growing evidence that parental involvement and behavioral changes are strong predictors of~     children weight loss. However, which form and content of parental involvement are most~     effective is not studied. In the present randomized controlled study we compare the effect of~     parent manualized group treatment (experimental group) to the effect of parent self-help~     groups on changes in children Body Mass Index, food intake, physical activity, quality of~     life and self esteem. We pose the following hypotheses:~        1. Parents participating in the experimental group will have children who achieve a larger~          reduction in BMI than children with their parents in the control group.~        2. This treatment effect will be mediated by changes in one of several elements of parents'~          cognition: outcome expectancies, perceived control, perceived value of outcome,~          self-efficacy, perceived reduction in barriers, and subjective norms.~        3. Reduction in BMI will correlate with increased quality of life, reduced number and~          severity of mental health problems, and increased self-concept.~   "
207677|NCT00842764|"~     The purpose of this research study is to is to evaluate the safety and effectiveness of the~     FDA approved Holmium:YAG laser for reducing lower eyelid bags.~   "
207678|NCT00842751|"~     The purpose of this study is to test how the body absorbs and processes new forms of oral~     testosterone. Information gained during the study may help develop better forms of~     testosterone therapy in the future.~   "
207679|NCT00842738|"~     In this study two questions will be answered:~        -  can mindfulness meditation help cell-changed on the cervix to disappear?~        -  can mindfulness meditation lower the psychological distress when women have abnormal~          cervical cancer screening results?~   "
207689|NCT00842595|"~     The primary objective of the protocol is to estimate the complete response rate of three~     courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone~     in relapsed aggressive non hodgkin's B-cell lymphoma~   "
207690|NCT00842582|"~     This is a clinical trial for women with newly diagnosed ovarian cancer. The purpose of this~     study is to determine if the addition of a drug called azacitidine (Vidaza®)when added to~     carboplatin and paclitaxel will change the genetic material of the tumor so that the~     chemotherapy drugs work better.~      The study will also determine what the maximum tolerated dose of azacitidine that may be~     safely used in combination with carboplatin and paclitaxel.~   "
207754|NCT00841737|"~     The purpose of this study is to compare the effectiveness and efficiency of doing a~     psychoeducational group program and the conventional treatment versus individual conventional~     care in patients with a mild/moderate depression disorder,in urban primary healthcare centers~     in Barcelona city.~   "
207680|NCT00842712|"~     Primary objective of the study's Safety run-in:~      - To determine the maximum tolerated dose (MTD) of cilengitide in combination with cetuximab,~     and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).~      Primary objective of the study's Randomization Part:~      - To assess the efficacy of cilengitide in combination with cetuximab and platinum-based~     chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine) compared to cetuximab and~     platinum-based chemotherapy alone in terms of progression-free survival (PFS) time.~      Study design and plan:~      This is a multicenter, open-label, randomized, controlled Phase II study with a safety run-in~     part in subjects with advanced non-small cell lung cancer (NSCLC).~      During the safety run-in, the regimen was intensified stepwise by cohort (cilengitide~     intravenous [i.v.] 1000 milligram [mg] to 2000 mg twice a week) in a classical 3+3 subjects~     (for each platinum-based chemotherapy regimens separately) approach with predefined dose- and~     schedule reduction rules.~      In the safety run-in 12 subjects were included and evaluated for safety and feasibility of~     different escalating doses of cilengitide administered twice weekly in combination with~     cetuximab, cisplatin and vinorelbine or gemcitabine.~      After completion of the safety run-in, the randomized part will be started, during which all~     subjects will receive cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or~     cisplatin/gemcitabine).~      Subjects will be centrally randomized on a 1:1 basis to either Group A or C; Group B will be~     closed with implementation of Amendment No. 4 (dated 20 December 2010):~      • Group A: Cilengitide 2000 mg once weekly (Days 1, 8, and 15 of every 3-week chemotherapy~     cycle) in combination with cetuximab and platinum-based chemotherapy that will consist of the~     following:~        -  Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and vinorelbine on~          Days 1 and 8 of every 3-week chemotherapy cycle, or~        -  Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and gemcitabine on~          Days 1 and 8 of every 3-week chemotherapy cycle.~      The decision which of the 2 chemotherapy regimens will be applied for a given subject is at~     the discretion of the treating investigator.~      • Group B: Cilengitide 2000 mg twice weekly (Days 1, 4, 8, 11, 15, and 18 of every 3-week~     chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy as~     described for Group A.~      Group B will be closed with implementation of Amendment No. 4 (global, dated 20 December~     2010). Subjects randomized to Group B before implementation of Amendment No 4 will continue~     to be treated as planned.~      • Group C: Cetuximab and platinum-based chemotherapy as described for Group A~      Chemotherapy will be given until radiographically documented progressive disease (PD) or~     unacceptable toxicity but for no more than 6 cycles.~      Cilengitide and cetuximab will be given until radiographically documented PD or unacceptable~     toxicity.~      Randomization will be performed centrally using an interactive voice/web response system~     (IXRS). A stratified block randomization procedure will be employed using chosen first-line~     chemotherapy (cisplatin/vinorelbine versus cisplatin/gemcitabine) as stratification~     criterion.~   "
207681|NCT00842699|"~     The goal of the study is to find out the effects of two different drugs used at the beginning~     of organ transplantation on different populations of immune cells in the body of patients.~   "
207682|NCT00842686|"~     The use of preoperative chemoradiation and adjuvant chemotherapy with 5-FU based chemotherapy~     reduced local recurrence rate to less than 10%, but has only had limited effect on overall~     survival due to the constantly high (more than 30%) rate of distant metastasis.~      However, it has been shown that complete eradication of the primary tumour observed in the~     histopathological specimen (pathological complete response, pCR) correlates with a favourable~     overall prognosis so obtaining a pCR might be beneficial. The aim of the study is to~     investigate whether the addition of bevacizumab to preoperative fluoropyrimidinebased~     chemoradiation improves pathological complete remission rate in locally advanced rectal~     cancer with acceptable toxicity. Secondary objectives are to evaluate pathological~     downstaging rate, histopathological R0 resection rate,sphincter preservation rate,~     perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality~     of life.~   "
207683|NCT00842673|"~     This study will investigate the ability of ST101 to improve memory in people with Alzheimer's~     disease. This study also will examine the safety and tolerability of the drug. This study is~     evaluating 3 different dose levels of ST101 and placebo. Patients will have a 1 in 4 chance~     of getting placebo.~   "
207684|NCT00842660|"~     Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment~     for patients with cervical cancer. However, in patients with advanced cervical cancer, half~     of them treated with contemporary radiotherapy plus single agent cisplatin still suffered~     from the local or distant relapse. How to improve the treatment outcome of these patients is~     a very important issue and requires further clinical investigation.~      The major aim of this project is to conduct a prospective, randomized phase III clinical~     trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and~     gemcitabine have better survival rates than those treated by radiotherapy with cisplatin~     alone.~      Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few~     clinical trials in early phases showed promising results when using concurrent radiotherapy~     with cisplatin and gemcitabine. According to these positive results, the investigators expect~     this trial has the potential to improve the survival in patients with advanced cervical~     cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.~   "
207685|NCT00842647|"~     This study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for~     hepatocellular carcinoma.~   "
207686|NCT00842634|"~     This research study is being carried out to study a new way to possibly treat HIV. This agent~     is called a Zinc Finger Nuclease or ZFN for short. ZFNs are proteins that can delete~     another protein named CCR5. This CCR5 protein is required for certain common types of HIV~     (CCR5 tropic) to enter into and infect T-cells. T-cells are one of the white blood cells used~     by the body to fight HIV. The most important T-cells are those called CD4 T-cells.~      Some people are born without CCR5 on their T-cells. These people remain healthy and are~     resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and~     their HIV disease is less severe and is slower to cause disease (AIDS).~      In order to delete the CCR5 protein on the T cells, this study will isolate large numbers of~     T-cells from subjects, and then deliver the ZFNs using a delivery vehicle called a viral~     vector. The viral vector used in this study is called an adenoviral vector. The vector is~     added to the cells at the beginning of the manufacture process and the ZFNs knock out the~     CCR5 protein. By the time T-cells are returned to subjects, there is minimal adenovirus or~     ZFN present. The removal of the CCR5 protein on the T-cells subjects receive, however, is~     permanent.~      The purpose of this research study is to find out whether zinc finger modified T-cells are~        1. safe to give to humans and~        2. find how zinc finger modified T cell affects HIV~      This is an experimental study. Laboratory studies have shown that when CD4 T-cells are~     modified with zinc fingers, HIV is prevented from killing the CD4 T cells. On the basis of~     these laboratory results, there is the potential that zinc fingers may work in humans~     infected with HIV and improve their immune system by allowing their CD4 T-cells to survive~     longer (HIV usually kills T cells it infects).~      All subjects who receive ZFN Modified CD4+T cells will enroll in a Long Term, Follow-up study~     to monitor subjects. Subjects will be followed every 3 months for four years. If the ZFN~     Modified CD4+T cells are no longer found in the blood after four years, then subjects will be~     contacted yearly for the next 6 years. If the ZFN Modified CD4+T cells are found in the blood~     at year four, then the subjects will continue to be seen once a year until the ZFN Modified~     CD4+T cells are no longer found in the blood for a maximum of 10 years.~   "
207687|NCT00842621|"~     In this prospective observational trial, participants with chronic hemolysis will be assessed~     with echocardiogram for elevated tricuspid jet velocity and other evidence of pulmonary~     hypertension. Participants will have laboratory studies evaluating: severity of hemolysis,~     splenic function, inflammation, endothelial dysfunction, and hypercoagulability. There will~     be 3 main categories of participants enrolled in this study: (1) pediatric participants with~     severe sickle cell disease (SCD) (HbSS, HbS/β° thalassemia ) who are not receiving treatment~     (e.g., hydroxyurea or chronic transfusions); (2) pediatric participants with other forms of~     SCD or severe SCD (HbSS, HbS/β° thalassemia) patients being treated with hydroxyurea or~     chronic transfusions; and (3) pediatric and adult participants with other non-sickling~     hematological disorders.~   "
207688|NCT00842608|"~     The purpose of this study is to develop and test the feasibility of using a specific~     pharmacological protocol to reduce delirium burden among older adults in the Intensive Care~     Unit (ICU). The study will test the efficacy of a pharmacological intervention in reducing~     delirium severity and duration as well as length of stay and mortality compared to usual~     care.~   "
207691|NCT00842569|"~     There is growing evidence of behavioural and neurobiological overlaps between obesity and~     drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP)~     elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of~     vulnerability in substance abuse. We want to determine whether obesity is associated with~     such electrophysiological features during an auditory oddball paradigm. We postulate that~     obesity could be associated with electrophysiological abnormalities that could be viewed as a~     possible vulnerability marker for food addiction.~   "
207692|NCT00842556|"~     To assess the effect of glimepiride on the PK of dapagliflozin and the effect of~     dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A)~     and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of~     dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)~   "
207693|NCT00842543|"~     Our study aims to evaluate if the consumption of a Fruit and Vegetable Juice Concentrate~     (FVJC) vs. placebo can exert changes in the serum levels of Retinol Binding Protein 4 (RBP4),~     carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity~     in conjunction with weight management in a cohort of lean as compared to overweight healthy~     six to ten year-old boys. The boys will undergo a detailed medical and family history and a~     complete physical examination during the screening visit. Careful anthropometric measures and~     body composition by DEXA will be performed. Nutritional and exercise counseling will be given~     at the start of the study. The outcome measures will include differences in serum RBP4,~     antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months~     after consumption of FVJC in a randomized double blind placebo control manner.~   "
207694|NCT00842530|"~     There is currently no vaccine against dengue and no specific drug treatment against the~     disease. This study is aimed at generating information on the protective effect of the~     vaccine.~      Primary Objective To assess the efficacy of dengue vaccine after three injections in~     children.~      Secondary Objective:~      To evaluate the reactogenicity of dengue vaccine after each injection in a subgroup of~     children.~   "
207695|NCT00842517|"~     The purpose of this study is to develop a model for long-term maintenance of behavior change~     by examining the effects of extending the duration of contingency management (CM) for drug~     abuse on long-term abstinence outcomes. The primary hypothesis is that the Extended (36 week)~     CM group will have better long-term outcomes as exhibited by greater rates of abstinence at~     each follow-up assessment as compared to the Standard (12 week) CM group.~   "
207696|NCT00842504|"~     The purpose of this study is to examine the pharmacokinetics of micafungin when it is given~     on an every other day schedule. The study will determine if every other day micafungin will~     provide drug exposure equivalent to daily dosing while reducing administration costs and~     improving patient convenience. Fifteen patients will be enrolled on this study. Blood samples~     for PK measurements will be obtained for 48 hours following a single dose of micafungin (3~     mg/kg).~   "
207697|NCT00842491|"~     The purpose of this study is to investigate whether endostar (recombinant human~     endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced~     gastric cancer is effective and safe.~   "
207698|NCT00842478|"~     Poor oral hygiene is associated with respiratory pathogen colonization and secondary lung~     infection.The possible association between oral care and incidence of VAP, and the role of~     dental plaque, mouth and tracheal colonization have not been firmly established. The~     investigators' hypothesis was that improving oral care with electrical toothbrushing might be~     effective in reducing the incidence of VAP.~   "
207699|NCT00842465|"~     Prolactin is known to play an important role in breast development and differentiation. Thus~     proliferative breast diseases are good models to unravel PRl / PRLR function in proliferative~     processes.~      The aim of this project is to identify and to characterize new mutants of the prolactin~     receptor gene within cohorts of benign or malign breast diseases with low or high occurrence~     frequency in human populations~   "
207700|NCT00842452|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in~     treating patients with gynecologic cancer that cannot be removed by surgery.~   "
207701|NCT00842439|"~     Understanding the joint neurobiological and social bases to aggression is critical to future~     attempts to tackle this major public health problem. The overarching goals are: (a) to~     conduct perhaps the most systematic integration of biosocial risk factors for childhood~     aggression in order to predict later aggression, (b) to conduct one of the very few biosocial~     interventions on childhood aggression, (c) to predict and treat two fundamentally different~     manifestations of aggression proactive and reactive aggression which likely have different~     etiologies and responsiveness to treatment. The specific aims are: (1) to assess biological~     (genetic, neurocognitive, brain imaging, neuroendocrinological, neurotoxin,~     psychophysiological, nutritional), psychosocial (neighborhood, family, school, peer,~     psychological) and psychiatric (ADHD, CD, ODD, depression, anxiety, PTSD,~     schizophrenia-spectrum) risk factors for male and female aggression in order to better~     predict later aggression, (2) to improve prediction by identifying the genetic, neuroimaging,~     psychophysiological, and neuroendocrinological factors that protect children who are socially~     at risk for a violence outcome, (3) to develop a genetic mouse model of aggression to test~     the effectiveness of nutritional interventions in reducing aggression, (4) to begin to~     develop a new biosocial approach to the treatment and prevention of aggression, based on both~     cognitive-behavioral and nutrition interventions, (5) to assess the differential prediction~     and treatment of two fundamental variants of child aggression: proactive and reactive~     aggression. The human sample will consist of 500 male and female 11-year-old children drawn~     from high-risk communities in Philadelphia. Three hundred participants will engage in a~     baseline assessment for risk factors for aggression, and then be randomly assigned to one of~     four three-month intervention programs: treatment-as-usual, cognitive-behavioral~     intervention, nutrition supplementation, or CBI + nutrition. Aggression outcome will be~     assessed throughout intervention and post-intervention.~      The investigators believe that biological risk factors will interact with social risk factors~     in predicting aggression, over and above main effects of these classes of risk factors.~     Treatment effectiveness will interact with risk factors: those with low omega-3 and high lead~     exposure at intake will benefit most from the nutritional intervention; those with cognitive~     and affective risk factors will benefit most from the neuro-cognitive-behavioral~     intervention.~   "
207702|NCT00842426|"~     The purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of~     two lifestyle interventions in a community based primary care setting. The study aims to~     assess how changes in diet, exercise, and behavioral self-management affect weight and~     related risk factors for adults at risk for diabetes and cardiovascular disease.~   "
207703|NCT00842413|"~     This project aims at understanding better the role of the frontal lobe of the brain in our~     capacity to perceive visual information consciously, and also, in our capacity to perceive~     others' actions. It includes a test where we ask subjects to detect visual information in~     front of a computer screen, and another test where we ask them to imitate finger movements.~   "
214012|NCT00758563|"~     The purpose of this study is to train new examiners while testing two commercial products~     using our standard one-day brushing study regimen by measuring gingival margin plaque index.~   "
207704|NCT00842400|"~     The purposes of this study are to:~        -  Find out how much of the study drugs are in the blood of healthy subjects after taking~          multiple doses of VI-0521, metformin and sitagliptan.~        -  Determine the effect of probenecid on the amount of VI-0521 in the blood of healthy~          subjects after taking multiple doses.~        -  Find out how much topiramate is in the semen of healthy male subjects after taking~          multiple doses.~   "
207705|NCT00842387|"~     The aim of this project is to compare the GERD clinical outcomes in patients where a~     structured pathway using the GerdQ questionnaire is implemented compared with the clinical~     outcomes of those treated without this implementation.~      This is a European project with 5 participating countries (Austria, Italy, Norway, Spain and~     Sweden). Due to different characteristics regarding the actual management of this disease in~     the 5 countries, each country had the flexibility to introduce design differences and changes~     in the study protocol.~   "
207706|NCT00842374|"~     This is a registry of patients with non ST segment elevation Myocardial Infarction (heart~     attack) and/or unstable acute coronary artery syndrome treated with a standardized protocol~     including Bivalirudin.~      Data will be collected on diagnosis, treatment and outcomes.~   "
207707|NCT00842361|"~     This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety~     (with emphasis on hypoglycaemia) after switching from long-acting insulin~     analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a~     twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily~     regimen in subjects with type 2 diabetes mellitus.~   "
207708|NCT00842348|"~     The primary purpose of this extension study was to assess the long term safety of patients~     with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open~     label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study,~     2-55-52030-726 (NCT00353496).~   "
207709|NCT00842335|"~     The purpose of this study, the first clinical trial of JI-101, is to determine the maximum~     tolerated dose of JI-101 when given orally to patients with solid tumors. Safety,~     tolerability, pharmacokinetics, pharmacodynamics, and the effects of the drug on tumor~     metabolism will also be studied. JI-101 is an inhibitor of new blood vessel growth that may~     provide benefit to patients with solid tumors that have failed standard therapeutic regimens.~   "
207710|NCT00842322|"~     Patients with renal impairment are usually advised to increase their fluid intake. There is~     currently, however, no evidence supporting this recommendation. In contrast,high fluid intake~     could be dangerous if urine excretion is reduced. In this study the researchers investigate~     whether increasing fluid intake from 2 to 4 litres per day has any influence on long-term~     renal outcome.~   "
207711|NCT00842309|"~     The purpose of the study is to conduct a double-blind, placebo-controlled study of~     D-cycloserine (DCS) augmentation of behavior therapy in individuals with Body Dysmorphic~     Disorder (BDD). Specifically, we intend to randomize 50 individuals with BDD to receive~     either DCS (n = 25) or placebo (n = 25) one hour prior to 8 of 10 behavior therapy sessions.~   "
207712|NCT00842296|"~     The purpose of this study is to confirm that the ClosureFAST system can be used as an~     alternative to the current ClosurePlus catheter for treating the GSV and to accumulate~     pivotal data for optimization of the operating parameters.~   "
207713|NCT00842283|"~     The researchers believe that pro-angiogenic factors are upregulated in a wide range of~     dermatologic diseases including port wine stains, hemangiomas, angiofibromas, Kaposi's~     sarcoma, angiosarcoma, scars, rosacea and psoriasis.~      The researcher can perform immunohistochemistry and/or microarray analysis and/or~     quantitative polymerase chain reaction on previously biopsied skin specimens and newly~     biopsied skin specimens to evaluate the expression of various angiogenic factors in these~     dermatologic diseases.~      In addition, some of the skin specimens may be utilized to make cell cultures to study~     expression of angiogenic factors and interactions of cells in dermatologic disease.~   "
207714|NCT00842270|"~     The aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010,~     administered at three dose levels during 4 months to patients with severe persistent~     corticosteroid dependent asthma, assessed on :~        -  the decrease in corticosteroid therapy~        -  the asthma control improvement (symptomatic scores, rescue medication intake,~          respiratory function)~        -  the pharmacokinetic profile of AB1010~        -  clinical and biological safety parameters~   "
207715|NCT00842257|"~     The purpose of this research study is to learn whether panitumumab helps treat colorectal~     cancer in participants who have not responded to treatment with cetuximab. Panitumumab is a~     human monoclonal antibody. Antibodies are proteins that recognize a foreign substance in the~     body and then attach themselves to it making it exposed to destruction. Panitumumab attaches~     itself to a protein on cancer cells called epidermal growth factor receptor or EGFR. EGFR~     helps cancer cells to grow, and blocking EGFR helps prevent cancer cells from growing.~   "
207716|NCT00842244|"~     The purpose of this study is to determine the safe and tolerable dose of axitinib given~     together with cisplatin and capecitabine in patients with advanced gastric cancer who have~     not received prior chemotherapy for their advanced cancer.~   "
207717|NCT00842231|"~     To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal~     astigmatism.~   "
207718|NCT00842218|"~     The purposes of this study were as follows: 1) to compare locomotion parameters (kinematic,~     EMG, mechanical work and energy cost changes during walking in able-bodied subjects and AIS~     patients,2) to evaluate the effects of the frontal curve's severity of the AIS and 3) the~     effects of the treatment (orthosis or surgery)on these gait parameters.~   "
207719|NCT00842205|"~     In the presented project, the role of heme oxygenase 1 and 2 in the procesess associated with~     fibroproduction in the chronic HCV infection will be studied. Heme oxygenase expression will~     be evaluated by the techniques of molecular genetics and immunohistochemistry, both in the~     liver tissue and in peripheral blood mononuclear cells. These parameters will be correlated~     with basic virological and clinical characteristics of the chronic HCV infection. The~     investigators' expected results may help in understanding the mechanisms of fibroproduction~     in chronic HVC infection and, therefore, contribute to explain individual differences in the~     development of chronic HCV infection.~   "
207720|NCT00842192|"~     This study is conducted in Asia. The aim of this observational study is to investigate the~     safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are~     using oral antidiabetic drugs.~   "
207722|NCT00842166|"~     The aim is to document viral etiologies of isolated fevers and inlfuenza-like syndromes~     during summertime in South of France in order to better understand the role of known~     vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the~     arthropod vector. In each of the four cities, a network of general practitioners will be~     associated in the project to recruit patients who are not hospitalized. The combined~     involvement of infectious disease specialists and general practitioner will augment the range~     of patients (mild disease and sever cases) in the study.~   "
207723|NCT00842153|"~     The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to~     that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.~   "
207724|NCT00842140|"~     The purpose of this study to assess early markers of cardiovascular disease in women with~     polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and~     chlormadinone acetate alone or associated with Spironolactone.~   "
207725|NCT00842127|"~     The purpose of this study is to examine whether genetic polymorphisms in drug transporters~     were associated with the side effects of OROS-methylphenidate medication in attention~     deficit/hyperactivity disorder(ADHD).~   "
207726|NCT00842114|"~     Rituximab plus CVP and Interferon chemoimmunotherapy for newly diagnosed Follicular Lymphoma~     with FLIPI index >2~   "
207727|NCT00842101|"~     The purpose of this study is to determine the effect of reamed intramedullary nails in tibial~     shaft fractures (as a standard treatment), in raising intracompartmental pressures and~     therefore determine if they are a risk factor for compartmental syndrome.~   "
207728|NCT00842088|"~     The purpose of this study is to assess the safety and tolerability of HQK-1001 administered~     for a total of 12 weeks (with one dosing break) in subjects with sickle cell disease.~   "
207729|NCT00842075|"~     The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin~     immediately prior to meals can significantly reduce post-prandial glucose concentrations~     compared with mealtime insulin alone in children with type 1 diabetes.~      This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking~     pramlintide before all meals) and a control arm (diabetes regimen as usual).~   "
207730|NCT00842062|"~     A prospective, non-randomized study to evaluate the performance of the MyoScience Tissue~     Remodeling Device for the treatment of glabellar lines (frown lines), lateral orbital lines~     (crow's feet), and frontalis lines (horizontal forehead lines).~   "
207731|NCT00842049|"~     Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average~     age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in~     younger people (25-45 years). Despite modern medicine, the death and disability rate remains~     high both from the initial bleed and from the associated complications such as vasospasm.~     This is characterised by neurological impairment seen following the bleed. Despite modern~     treatment this is still associated with a poor outcome. This has significant implications due~     to the long term intensive neuro-rehabilitation these patients will require.~      A recent study has shown that placing a small drain in the lower back following a~     subarachnoid haemorrhage may reduce the chance of vasospasm occurring and result in a better~     outcome. This trial was not optimally performed and so a trial is needed to look at this in~     more detail. The investigators have set up such a trial in our neurosurgical unit. If the~     investigators confirm that there is an improvement in patient outcome, it will change our~     practice in the future.~   "
207732|NCT00842036|"~     This research compares the benefits of the original treatment, Community Reinforcement and~     Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to~     determine if TEnt alone can produce the primary outcome of CRAFT -- treatment entry of the~     drug user. We also look at the impact on the well-being of the concerned significant other~     and the drug use of their loved one.~   "
207733|NCT00842023|"~     The purpose of this study is to determine whether Nesiritide is more effective than~     nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity~     when proper infusion duration is administered.~   "
207734|NCT00842010|"~     This retrospective nested non-matched case control study compared patients directly admitted~     to the General Medicine Wards, not transferred from ICU with~        -  hyperglycemia on admission but no previous diagnosis of diabetes~        -  diabetic hyperglycemic patients~        -  non hyperglycemic non diabetic patients from the same nested population.~      The investigators' hypothesis is that the clinical characteristics and endpoints of the non~     diabetic hyperglycemics should be similar to the diabetic population and different from the~     non diabetic non hyperglycemic population.~   "
207735|NCT00841984|"~     The search for metabolic abnormalities in patients with neurological disorders represents an~     important challenge 1) to identify new potentially treatable inherited metabolic diseases,~     and 2) to identify biomarkers or new treatments in more common neurodegenerative or~     neurogenetic disorders.~      This approach is currently limited by the fact that techniques aiming at identifying abnormal~     metabolites in human fluids (metabolomics) only detect subsets of molecules and that no~     general assays is available to detect abnormalities in the metabolism of complex molecules~     that takes place within cell organelles. As a consequence, only limited parts of the~     metabolism can be studied simultaneously.~      The aim of this study is to evaluate whether NRM spectroscopy of body fluids (urines,~     cerebrospinal fluid) could allow to detect new metabolic abnormalities in patients with~     complex neurological diseases.~   "
207736|NCT00841971|"~     The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for~     the prevention of fungal diseases in liver transplant recipients~   "
207737|NCT00841958|"~     The primary objective of this study is to test that endocardial stem cells implantation in~     patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and~     PCI or despite on previous revascularization improves long-term survival compared to MED~     alone~   "
207738|NCT00841945|"~     Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy~     after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and~     localized B lymphoma , age 18 to 75 years.~   "
207739|NCT00841932|"~     The purpose of this study is to assess the safety of performing fractional flow reserve (FFR)~     of the myocardium without using anticoagulation by performing a retrospective review of 100~     consecutive patients who have undergone this procedure during diagnostic catheterization.~   "
207741|NCT00841906|"~     The objective of this study is to test the usability of the Alice PDx device by both the end~     user (patient/participant) and the sleep technician. Data will be collected via~     questionnaires regarding the participant's ability to understand the participant user manual~     under home conditions and the technician's ability to set up the Alice PDx according to the~     health care provider manual. This study will also compare the physiological data recorded by~     the Alice PDx to the physiological data recorded by its predicate device the Alice 5 System~     and validate its equivalence. This will be evaluated by comparing the manual study scores for~     detected apnea and hypopnea events and on an event by event basis during a standard~     polysomnography (PSG)/ sleep study. The study will test the ability of the Alice PDx to~     record good quality data as determined by the Good Study Indicator (GSI) function of the~     Alice PDx firmware.~      The primary hypothesis is that the participant will be able to successfully apply the Alice~     PDx basic leads following the participant user manual instructions and the sleep technician~     will be able to successfully apply the advanced leads in preparation for the sleep study. In~     addition, it will be demonstrated that the Alice PDx is equivalent to the Alice 5 System in~     its intent to record, display and print physiological data to the clinician/physician in~     order to aid in the screening/follow-up diagnosis of respiratory sleep disorders.~   "
207742|NCT00841893|"~     The objective of this study is to examine whether a specific spice is capable of affecting~     energy metabolism.~      Since chili and other spices have been shown to increase energy expenditure and in some cases~     also affect energy intake/appetite compared to placebo, the investigators expect that the~     specific spice may actually increase energy expenditure and potentially also decrease~     appetite - although not to a large degree.~   "
207743|NCT00841880|"~     The objective of this study is to compare the reduction in office seated systolic blood~     pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril~     10mg.~      To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic~     blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined~     as SBP<140mmHg and/or DBP<90mmHg) and as SBP < 130 mmHg and /or DBP < 80 mmHg in~     diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or~     10-year Framingham risk score > 10%.~      To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese~     population.~      To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril~     treatment.~   "
207744|NCT00841867|"~     The purpose of this study is to examine changes in sugar metabolism that may occur in~     subjects who have previously had part of their pancreas removed due to a benign lesion.~   "
207745|NCT00841854|"~     At present, triple therapy are recommended by various guidelines for the treatment of~     Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment~     failure rates with one week first line clarithromycin based triple therapy necessitating~     salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact~     duration of bismuth based second line treatment is not determined. Therefore, the~     investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple~     regimen as a second-line therapy.~   "
207746|NCT00841841|"~     Adequate postoperative pain management is challenging for practitioners despite recent~     advances in pain control techniques and analgesic agents. The purpose of this study is to~     compare the efficacy of Dipyrone and acetaminophen in postoperative pain after third molar~     surgery.~   "
207747|NCT00841828|"~     Phase II randomized multicenter Trial to compare Epirubicine and Cyclophosphamide plus~     Docetaxel and Trastuzumab with Epirubicine and Cyclophosphamide plus Docetaxel and Lapatinib~     for patients with positive HER2 neu and resectable breast cancer or locally advanced breast~     cancer.~   "
207748|NCT00841815|"~     The objective of this study is to compare the rate and extent of absorption of amlodipine~     from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc®~     10 mg Tablets under fed conditions.~   "
207749|NCT00841802|"~     This is a study to evaluate the cause of chronic sinus disease. Oral steroids have long been~     used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and~     arthritis. However, it is not well known exactly which patients will benefit from steroids~     when used in the treatment of chronic sinusitis. For some doctors, it is common practice to~     use these medications prior to planned sinus surgery, to lessen the inflammation and possibly~     help the healing process. Other doctors feel oral steroids may not be helpful in this way,~     and there is no conclusive data as to whether this practice has a long term benefit.~   "
207750|NCT00841789|"~     The purpose of this study is to determine whether Etanercept (Enbrel) when used in~     conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with~     Kawasaki Disease. Funding Source- FDA/OOPD~   "
207751|NCT00841776|"~     The purpose of the study is to determine the development of microbial resistance when using~     one of two topical acne therapies for the treatment of facial acne vulgaris.~   "
207752|NCT00841763|"~     The present study, phase III, randomized, controlled, observer-blind, multicenter study, will~     evaluate safety, tolerability and immunogenicity of two doses of an adjuvanted monovalent~     influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine in a~     population of healthy adult and elderly subjects.~   "
207753|NCT00841750|"~     After performing VATS pulmonary wedge resections, a chest tube is routinely left in the~     pleural cavity to drain possible air leaks and fluid accumulations. Chest tubes after VATS~     pulmonary wedge resections are left in place a minimum of 1 day. However, this practice has~     no scientific foundations. The investigators believe it is possible to avoid the placement of~     a chest tube after this procedure in a great amount of patients. This is a randomized~     controlled clinical trial with analysis blinding in which the investigators want to compare~     the outcomes between installing a chest tube or not after VATS pulmonary wedge resections.~     The investigators will include consecutively patients with interstitial lung disease or~     indeterminate pulmonary nodules undergoing this procedure, at the participating institutions.~     The investigators calculated a sample size of 50 subjects in each group using pneumothorax <~     10% data from Luckraz et al and to determine a difference of hospital stay of 2 versus 1 day;~     DS(1.5), power = 0.9 and alpha = 0.05.~   "
207769|NCT00841542|"~     The objective of this study is to compare the rate and extent of absorption of amlodipine~     from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc®~     10 mg Tablets under fasting conditions.~   "
207755|NCT00841724|"~     The goal of this prospective study is to assess the overall mortality (whether related to~     relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell~     transplantation prepared by a so-called reduced-toxicity submyeloablative conditioning~     regimen in patients with hematological malignancies.~   "
207756|NCT00841711|"~     TRANSITIONS, a novel jail-release program for People Living with HIV/AIDS (PLWHA), will use~     evidence-based interventions and adapt them to create a comprehensive transitional program in~     Waterbury and New Haven County, Connecticut. Evidence-based interventions will include, but~     not be limited to, enhanced rapid HIV testing within the New Haven Community Correctional~     Center (NHCCC, local jail), intensive case management, continuity of buprenorphine treatment~     from the jail to the community setting and a novel Money Management (MM) program.~      The HIV in Prisons Program and the Community Health Care Van (CHCV) at the Yale University~     AIDS Program, in collaboration with the Connecticut Department of Correction and the~     Waterbury Hospital Infectious Diseases Clinic, propose to expand the availability of opiate~     substitution treatment and to enhance clinical and social services for PLWHA, who are~     transitioning from the jail to the community setting.~      As part of Transitions, we will develop a model Money Management program that we have used in~     community settings to improve health outcomes for socially and medically marginalized~     populations and adapt it for a jail-release program. The Transitions program will incorporate~     these elements into a combined intervention and will result in a clinical trial to compare~     the additional contribution of a money management program.~   "
207757|NCT00841698|"~     The objective of this study is to compare the rate and extent of absorption of paroxetine~     hydrochloride 40 mg film-coated tablets (test) versus Paxil® (reference) administered as 1 x~     40 mg film-coated tablet under fasting conditions.~   "
207758|NCT00841685|"~     Implantation of fiducial markers in the prostate and daily check of the positioning during~     radiotherapy based on the implanted fiducial markers~   "
207759|NCT00841672|"~     This study will compare the blood pressure (BP) lowering effect of the combination of~     aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate~     to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine~     produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP)~     after 8 weeks of treatment.~   "
207760|NCT00841659|"~     The objective of this study is to compare the rate and extent of absorption of paroxetine~     hydrochloride 40 mg film-coated tablets (test) and Paxil® (reference) administered as 1 x 40~     mg film-coated tablet under fed conditions.~   "
207761|NCT00841646|"~     The present study will evaluate the immunogenicity, safety and tolerability of two doses of~     monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a~     surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult and Elderly~     Subjects.~   "
207762|NCT00841633|"~     The purpose of this study is to test the feasibility of a trial on induced hypertension to~     improve neurological outcome in patients with subarachnoid haemorrhage that developed the~     serious complication delayed cerebral ischemia, and to assess whether induced hypertension~     results in improved cerebral blood flow (CBF) as measured by means of perfusion-CT.~   "
207763|NCT00841620|"~     Background: In an international randomised controlled trial we studied how patient~     self-reported symptoms improved after either a stapled anopexy operation or a diathermy~     excision of the haemorrhoids.~      Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Two hundred and seven~     patients were randomised. After exclusion of 27 patients, 90 in both groups were operated and~     followed one year. Patients provided self-reported symptoms before surgery and after 1 year.~     A patient diary obtained daily self-reported postoperative pain scores (VAS). Surgeons~     evaluated the anal anatomy before surgery and after 1 year.~   "
207764|NCT00841607|"~     Pancreaticoduodenectomy (PD or Whipple procedure) involves the removal of the head of the~     pancreas and is the primary modality for treatment of peri-ampullary cancers (arising from~     the common bile duct, Ampulla of Vater, duodenum, neuroendocrine cells of the pancreas, and~     most commonly the exocrine pancreas). In Canada, cancer of the pancreas is the 11th cancer in~     terms of new cases/year, and the 5th leading cause of cancer related deaths/year. Following~     PD the remaining pancreas is re-connected to a portion of the gastrointestinal tract; the~     pancreas is very soft and difficult to sew and connect safely. The primary cause of~     complications following PD is related to leak occurring at this connection. Of patients that~     develop a leak, over half need a second operation, and up to 40% will die. The two main~     organs that the pancreas may be re-connected to are the jejunum or the stomach. The~     investigators will compare the rates of pancreatic leakage in two groups of patients~     randomized to reconnection to either the jejunum or stomach following PD. The goal of this~     study is to determine which of these methods is safer. The results may change practice~     patterns across North America and the world. It may in the future prevent many cases of~     avoidable leakage and the resulting morbidity of this including death. This will therefore~     reduce the morbidity and mortality of this group of cancer patients.~   "
207765|NCT00841594|"~     The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical~     cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.~   "
207766|NCT00841581|"~     Patients with Pigment Epithelial Detachments secondary to Age-Related Macular Degeneration~     (AMD) will receive intravitreal Lucentis monthly for 6 months in the hope of improving visual~     acuity from a baseline evaluation.~   "
207767|NCT00841568|"~     Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral~     administrations at doses of 15 mg twice daily in patients with ADPKD who completed the~     preceding dose-finding study (156-04-001).~   "
207768|NCT00841555|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy~     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and~     cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may~     kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when~     given together with radiation therapy in treating patients with newly diagnosed glioblastoma~     multiforme or anaplastic astrocytoma.~   "
207770|NCT00841529|"~     The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to~     occlude the LAA~   "
207771|NCT00841516|"~     This trial is performed for the immunological and histological evaluation of specific~     immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of~     the major birch pollen allergen, rBet v1-FV~   "
207772|NCT00841503|"~     Bioactive components in buckwheat enhance insulin sensitivity in Type 2 diabetes by improving~     glucose uptake and utilization through a unique mechanism that operates independent of~     insulin.~   "
207773|NCT00841490|"~     The purpose of this study is to determine if the bacteria that cause gastric infections can~     be found in the mouths of intellectually and developmentally disabled persons. If the~     bacteria that causes gastric infections is found in the mouth it may be swallowed and~     contribute to gastric infections.~   "
207774|NCT00841477|"~     The goal of the proposed study is to use the HBV vaccine as a model for a future HIV vaccine~     trial, examining the efficacy of community-based outreach intervention as well as an~     accelerated vaccine schedule as a method for increasing acceptance/adherence with HBV~     vaccination protocols among not-in-treatment drug users. This study will also examine the~     effect of HBV vaccination coupled with community-based outreach intervention on reducing the~     incidence of HIV, HBV and HCV infections and the frequency of needle use and sexual risk~     behaviors related to these viral transmissions. A secondary purpose will be to assess the~     antibody response after HBV vaccination as a measurement of immunological response in drug~     users.~   "
207775|NCT00841464|"~     The purpose of this research study is to test the usefulness of external magnetic stimulation~     (EMS) for treating the motor, cognitive, and neuropsychiatric symptoms of Parkinson's disease~     (PD).~      Participants with Parkinson's disease will be recruited at the PADRECC of the Philadelphia VA~     Medical Center. Enrolled participants will be randomly assigned to receive either active~     external magnetic stimulation or fake stimulation. The external magnetic stimulation is~     delivered by wearing a helmet that is embedded with many small circuits which produce a very~     small magnetic field around the head. The helmet is to be worn daily for two minutes~     immediately before bedtime for three months in a row. The helmet is for investigational use~     only and has not been approved for use by the FDA.~   "
207776|NCT00841451|"~     Fish oil therapy may decrease the incidence of cardiac arrhythmias. This study will test~     whether pre-treatment with fish oils before catheter ablation of atrial fibrillation~     decreases the early post operative occurrence of atrial fibrillation.~   "
207777|NCT00841438|"~     The ADMIRAL (Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute~     myocardial infarction) study demonstrated that early administration of abciximab in patients~     with ST elevation acute myocardial infarction prior to PCI improves clinical outcomes but no~     specifically designed randomized study has addressed the issue of early upstream use of GP~     IIb/IIIa inhibitors in ST elevation acute myocardial infarction who are undergoing PCI,~     especially in the era of routine pretreatment with 600 mg of clopidogrel. Therefore, the~     objective of the randomized ECLAT-STEMI study was to assess the hypothesis that the early~     upstream use of Clotinab is a useful therapy in patients with ST elevation MI undergoing PCI~     compared to provisional use, even after pretreatment with a 600-mg loading dose of~     clopidogrel.~   "
207778|NCT00841425|"~     Previously the investigators have found that adolescent elite swimmers, who have been~     involved in competitive swimming for only a few years, have not developed respiratory~     symptoms, signs of airway inflammation or airway hyperresponsiveness exept for a slight~     increase in airway responsiveness to eucapnic voluntary hyperpnea. In the current study, the~     investigators will be doing a 3-year follow-up study on the swimmers studied previously.~   "
207779|NCT00841412|"~     Background: Numerous studies have shown that many LTC residents receive inadequate staff~     assistance with eating, which places them at risk for under-nutrition, dehydration and weight~     loss. Moreover, improvements in feeding assistance care have been shown to improve residents'~     daily food and fluid consumption and weight loss outcomes.~      Objectives: The purpose of this program evaluation project is to train indigenous LTC staff~     how to improve nutritional care within the constraints of existing staffing resources.~      Methods: A multiple baseline design was used to evaluate the effectiveness of the program in~     one federal and one state VA LTC facility. Research staff collected baseline measures related~     to nutritional care processes and resident outcomes. All LTC units in each of the two sites~     were divided into two groups for program implementation. The program was implemented with~     staff and residents on the units in the immediate intervention group; while, the delayed~     intervention group remained in usual care and continued to be monitored monthly for all care~     process and resident outcome measures.~      Status: This project ended 10/1/13. Five published papers resulted from this study.~   "
207780|NCT00841399|"~     The purposes of this study are the following:~        1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75)~        2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the~          peptide vaccine~        3. To evaluate the in vivo cellular immune response to the peptide vaccine~        4. To evaluate time to recurrence in the vaccinated patients vs. matched controls~   "
207781|NCT00841386|"~     The purpose of this study is to determine the effectiveness of collagen cross-linking in the~     cornea in halting the progression and possibly partially reversing the effects of~     keratoconus. Keratoconus is a progressive weakening in the cornea that causes irregular~     astigmatism and thinning of the cornea. The overall effect is reduction of vision, and in~     more advanced cases, scarring of the cornea that may lead to the need for corneal~     transplantation. Cross-linking has been shown increase the rigidity of the cornea. The~     patients would be treated once and then followed over 24 months. .~   "
207782|NCT00841373|"~     The object of the study is to compare treatment of iris/angle neovascularization with~     panretinal photocoagulation (laser) to treatment with panretinal photocoagulation and an~     anti-angiogenic drug: ranibizumab.~   "
207783|NCT00841360|"~     This is a pilot study with a cross-sectional research design to recruit Hispanic/Latina and~     African American adolescent and young adult women, aged 13-24 years to serve as index~     recruiters, who will in turn recruit members of her female friendship network, aged 13 years~     and older to undergo HIV screening. This approach seeks to identify new HIV infections in the~     target population.~   "
207784|NCT00841347|"~     This study aims to investigate~        1. whether sleep extension results in improvements of endocrine and metabolic markers of~          obesity and diabetes in obese teenagers,~        2. the relationship between habitual sleep quality and duration and markers of obesity and~          diabetes in lean and obese teenagers.~   "
207785|NCT00841334|"~     Community based participatory research principles will be used to create, implement and~     evaluate a culturally relevant and age-appropriate obesity intervention for adolescents who~     are overweight or obese. The intervention will be implemented through school-based health~     centers (SBHC) and will include clinical encounters with SBHC providers, use of Motivational~     Enhancement Therapy to help overweight/obese adolescents adopt healthier behaviors, and use~     of a community advisory council to develop obesity risk reduction strategies that will be~     delivered by print and digital video disc (DVD) media. To test efficacy of the ACTION~     intervention, overweight/obese adolescents will be recruited to either the intervention~     condition or the usual care condition. Students will have pre- and post- intervention~     measurements to assess if adolescents in the intervention condition will have improved risk~     factor profile for metabolic syndrome, improved nutrition and increased physical activity~     when compared with students in the usual care condition.~   "
207786|NCT00841321|"~     The purpose of this study is to see if treatment with Ginkgo improves cognitive function in~     people with multiple sclerosis who have cognitive problems.~   "
207787|NCT00841308|"~     This is a prospective randomized study with two arms: the Conventional and Ambulatory blood~     pressure monitoring arm and the Home blood pressure monitoring arm. The study will include~     both previously treated and untreated individuals.~      Before randomization and in the end of the study, measurements will be performed using all~     three blood pressure monitoring methods (Conventional, Ambulatory and Home) as well as~     assessment of target organ damage (microalbuminuria, electrocardiogram, echocardiogram,~     carotid-femoral pulse wave velocity and central blood pressure).~      The participants will be randomized into one of the two arms. Diagnosis and titration will be~     decided according to either Conventional and Ambulatory blood pressure measurements or~     according to Home blood pressure measurements. Subjects will be followed up for one year.~   "
207788|NCT00841295|"~     Background: Carnitine is the essential cofactor for various enzyme activities of human~     metabolism, especially for the mitochondrial carnitine shuttle that transfers long-chain~     fatty acids as acylcarnitine esters across the inner mitochondrial membrane for~     Beta-oxidation and energy production. Intracellular carnitine deficiency induces an~     impairment of long-chain fatty acid oxidation. In human, approximately 75% of carnitine comes~     from the diet and 25% from endogenous liver synthesis. In the neonatal period, more~     specifically in the premature, liver synthesis capacity is reduced because of immaturity of~     the biosynthetic pathway, and carnitine levels are related to exogenous sources.~     Traditionally, carnitine is not added to parenteral nutrition. Indeed, without enteral feeds~     and carnitine supplementation of parenteral nutrition, preterm infants' plasma carnitine~     levels fall during the first weeks of life, particularly in subjects requiring a prolonged~     exclusive parenteral nutrition. The potential deleterious role of carnitine deficiency has~     not been clearly demonstrated in these infants. However, most patients with primary carnitine~     deficiency, a genetic defect of carnitine transport inducing a severe carnitine deficiency,~     commonly develop liver symptoms (encompassing visceral steatosis, hyperammonemia and~     recurrent hypoketotic hypoglycemias) and/or cardiomyopathy and myopathy. In these latter~     patients, carnitine supplementation improves all the symptoms.~      Hypothesis: Carnitine deficiency of the premature and very low birth weight infants may be~     one of the factors involved in the liver disease frequently associated with prolonged~     parenteral nutrition, and may have deleterious effects on cardiac and muscle metabolism and~     functions.~      Aims: To demonstrate beneficial effects of parenteral carnitine supplementation in premature~     neonates for liver, heart and muscle metabolism and functions.~      Study Type: Multicentric prospective and randomised study~      Subjects: Premature and very low birth weight neonates, defined by gestational age minor or~     equal to 28 weeks and/or birth weight minor or equal to 1000 grams, 80 subjects will be~     enrolled during 2.5 years~      Interventions: Arm 1 (experimental): parenteral carnitine supplementation (9 ± 1 mg/kg/d),~     from day 4, until than enteral nutrition provides sufficient carnitine source; Arm 2 (Placebo~     comparator): parenteral supplementation with an equivalent volume of sterile water.~   "
207789|NCT00841282|"~     Our aim is to perform a randomized-controlled trial comparing air insufflation sedated~     colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by~     supervised trainees. Randomized trials demonstrating reduced need for sedation medications~     without compromising patients' comfort, cecal intubation rates or polyps detection may cause~     a paradigm shift and positively alter the way traditional colonoscopy is performed and future~     endoscopists are trained.~   "
207790|NCT00841269|"~     The purpose of the study is to see if the investigational medication uridine reduces~     depression symptoms in adolescents with bipolar disorder. Uridine is a naturally occurring~     chemical that is made by the human liver. Uridine is part of a family of compounds called~     pyrimidines, and is normally involved in many of the body's processes such as the use of~     energy by cells. Uridine is considered experimental, because it has not been approved by the~     U.S. Food and Drug Administration (FDA) to treat bipolar depression in adolescents. The study~     will use standard methods of assessing adolescent's mood, such as rating scales and~     questionnaires. In addition, the study will use Magnetic Resonance Imaging Spectroscopy~     (MRI/MRS) brain scans to see if levels of certain chemicals in the brain change when~     adolescents are treated with uridine. These scans use a magnet to create images of the brain,~     and do not expose patients to radiation.~   "
207791|NCT00841256|"~     Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens~     formulated as solution in comparison to a symptomatic standard treatment with add on placebo~     in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with~     or without bronchial asthma.~   "
207792|NCT00841243|"~     Standard antiviral treatment consists of weekly injections with Peginterferon-α in~     combination with ribavirin. This treatment may lead to significant weight loss (7% within 24~     weeks on average), with decreased quality of life. In this study the investigators will~     examine in 50 patients whether nutritional advise and support can prevent weight loss during~     antiviral therapy.~   "
207793|NCT00841230|"~     The purpose of this study is to investigate whether increased tinnitus reduction can be~     obtained with Deanxit in patients already receiving Rivotril.~   "
207794|NCT00841217|"~     The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable~     effect on lipoprotein metabolism.~   "
207795|NCT00841204|"~     This randomized phase II trial is studying how well sulindac works in preventing melanoma in~     healthy participants who are at increased risk of melanoma. Sulindac may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether sulindac is more effective than a placebo in preventing melanoma in individuals with~     many moles and abnormal moles.~   "
207796|NCT00841191|"~     The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in~     participants with solid malignant (cancerous) tumors (a mass in a specific area) and to~     estimate the clinical benefit of siltuximab monotherapy in participants with ovarian cancer~     and with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant tumors.~   "
207929|NCT00839397|"~     This was a 52-week, non-comparative, uncontrolled study of paroxetine in Japanese PTSD~     patients to obtain clinical experience regarding efficacy and safety. In this study, subjects~     received paroxetine 20mg-40mg once daily after an evening meal.~   "
207797|NCT00841178|"~     Varicose veins are a common problem, affecting up to a third of the western adult population.~     Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications~     include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is~     known to have a significant negative effect on patient's quality of life (QoL).~      Surgery has been used for many years, but it is known that there is a temporary decline in~     QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged~     recovery in some patients and has the risks of infection, haematoma and nerve injury.~      Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated~     persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at~     34 years.~      26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.~      Newer, less invasive treatments are being developed. It would be advantageous to find a~     treatment that avoided the morbidity of surgery, one that could be performed as a day-case~     procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and~     allow an early return to work. These should be the aims of any new treatment for varicose~     veins.~      Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser~     energy delivered into the vein to obliterate it. The vein therefore need not be tied off~     surgically and stripped out.~      The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery~     and EVLT.~   "
207798|NCT00841165|"~     Carbon monoxide (CO) has been called a silent killer, and those patients who survive CO~     poisoning are at risk of neurological damage, which may be permanent. CO is a leading cause~     of unintentional poisoning deaths in the United States, and the odorless gas results in an~     estimated average of 20,636 emergency department (ED) visits each year. Oxygen is the~     antidote for CO poisoning, and it acts both by attenuating toxic effects and enhancing~     elimination. A fractional inspired concentration of oxygen (FiO2) of 0.7 to 0.9 may be~     achieved by administration of 100% oxygen delivered using a reservoir with a facemask that~     prevents rebreathing. Hyperbaric oxygen therapy may provide added benefit for patients with~     CO poisoning, but this therapy is unavailable in many parts of the United States including~     Vermont. Use of a continuous positive airway pressure (CPAP) mask may achieve an FiO2 of 1.0,~     but the effects of delivering an FiO2 of 1.0 compared to 0.7 in CO poisoning are unknown.~     CPAP, by comparison, is inexpensive, portable, and available in most EDs. In this study, the~     investigators are testing the hypothesis that oxygen delivered by CPAP will improve both CO~     washout kinetics and functional outcomes, compared to the standard therapy of oxygen~     delivered by non-rebreathing facemask. Specific Aim 1 will provide toxicokinetic data to~     support a potential benefit in the use of CPAP for CO poisoning, by comparing CO elimination~     kinetics in response to oxygen therapy delivered by non-rebreathing facemask versus CPAP. The~     20 patients expected in our first year will provide adequate power to detect a 20% fall in~     half-time of CO elimination. While CPAP may increase CO washout rates, as predicted in~     Specific Aim 1, demonstration of real functional benefit will be tested in Specific Aim 2.~     This Aim seeks to determine functional (neuropsychological) outcomes in patients with CO~     poisoning treated with oxygen therapy delivered by non-rebreathing facemask versus CPAP. Data~     showing a therapeutic benefit from CPAP in CO poisoning would have clinical implications.~     Compared to hyperbaric oxygen therapy, CPAP therapy can begin earlier, including the~     pre-hospital setting, for patients with known exposure. With the frequent nature of CO~     poisoning and the widespread availability of CPAP, a potential benefit could lead to improved~     outcomes for the 20,000+ patients who present to EDs annually.~   "
207799|NCT00841152|"~     This study is designed to perform a head-to-head comparison of two synthetic ceramic bone~     graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of~     contained bone defects following surgical evacuation of benign bone tumor or tumor-like~     conditions. Based on the investigators' previous preclinical research and an ongoing~     single-center randomized clinical trial on bioactive glass filling, the investigators expect~     BAG filling to be more efficient compared to TCP in promotion of defect healing and~     functional recovery after surgery.~   "
207800|NCT00841139|"~     Conventional measures used for the treatment of chronic heart failure act predominantly by~     reducing the work performed by the heart. In a recent study, the investigators showed that~     one drug (perhexiline) substantially improved symptoms and cardiac function in heart failure.~     The investigators wish to confirm these findings and test whether or not this drug acts by~     altering the heart's energy source thus augmenting the energetic status and work efficiency~     of the heart.~   "
207801|NCT00841126|"~     Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food,~     reducing the amount that the body can absorb.~      The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in~     subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum~     carbonate and placebo.~   "
207802|NCT00841113|"~     To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients~     with advanced or metastatic prostate cancer.~   "
207803|NCT00841100|"~     The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness~     in the same patients with PKU when their blood phenylalanine concentrations are altered by~     diet.~      Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will~     increase the frequency of Kuvan responsiveness.~   "
207804|NCT00841087|"~     This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety~     (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or~     intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in~     subjects with type 1 diabetes mellitus.~   "
207805|NCT00841074|"~     The purpose of this study is determine if topical oral application of a chlorhexidine~     antimicrobial spray will significantly reduce pneumonia and respiratory infections, and~     improve oral health compared to a placebo solution in nursing home residents.~   "
207806|NCT00841061|"~     The purpose of this research study is to determine whether the type of iron in infant cereals~     makes a differance in how well the cereal helps infants remain free of iron deficiency.~   "
207807|NCT00841048|"~     The primary aim of this study is to investigate the safety and tolerability of AZD4017 when~     given as multiple oral ascending doses to healthy volunteers. This will be done by comparing~     the effect of AZD4017 to placebo. The study will aslo investigate the absorption,~     distribution and disappearance of AZD4017 in the body. Information about plasma~     concentrations of AZD4017 vs time after dose intake will also be collected and some measures~     of pharmacokinetics versus pharmacodynamics will be included. The future indication for~     AZD4017 is planned to be Type 2 Diabetes Mellitus.~   "
207831|NCT00840723|"~     The purpose of this research study is to collect cells and liquid from the air passages of~     healthy adults, both smokers and non-smokers. These samples will be used for test-tube~     studies to explore mechanisms of diseases of the respiratory tract, and to compare the~     samples between people who smoke cigarettes and people who don't. Obtaining these samples~     requires an invasive procedure called bronchoscopy.~   "
207832|NCT00840710|"~     The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow~     contraction in a women in active labor.~   "
207808|NCT00841035|"~     1.1 Primary Objective~      To evaluate the effects of short course preoperative erlotinib treatment in a panel of~     predictive biomarkers from a group of patients who undergo resection of pancreatic~     adenocarcinoma with curative intent.~      1.2 Secondary Objectives~      1.2.1 To analyze the effects of short course preoperative erlotinib treatment followed by~     postoperative erlotinib-gemcitabine therapy in the disease-free survival of patients who~     undergo curative intent resection of pancreatic adenocarcinoma.~      1.2.2 To evaluate secondary endpoints of disease response such as duration of overall~     survival and patterns of recurrence for patients with resectable pancreatic cancer who~     undergo this treatment regimen.~      1.2.3 To evaluate the plasma pharmacokinetics of erlotinib in pancreatic cancer patients both~     in the preoperative and postoperative setting, and to explore correlations between plasma and~     tumor erlotinib concentrations.~      1.2.4 To develop a clinically relevant predictive assay of response to erlotinib based on~     selected biomarkers in endoscopic ultrasound-fine needle aspiration (EUS-FNA) specimens when~     it can be obtained at the time of pancreatic cancer diagnosis in chemotherapy-naive patients.~   "
207809|NCT00841022|"~     This study aims to investigate whether detailed and illustrated information (comics) about~     anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.~      Children scheduled for craniotomy are randomized to groups receiving a comic leaflet~     explaining the course of anaesthesia before preanaesthesia visit or no intervention.~      Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.~   "
207810|NCT00841009|"~     Obesity affects more than 43 million Americans and is associated with an increased incidence~     of heart failure, sudden death, and cardiovascular death. We have shown that increasing~     obesity is independently associated with potentially detrimental LV structural and~     functional, and metabolic changes. Thus in order to increase our understanding of the effect~     of obesity on the heart, we wish to study the effect of significant weight loss on these~     parameters.~   "
207811|NCT00840996|"~     The purpose of this study is determine if epidural anesthesia administered after surgery or~     lidocaine administered during surgery will decrease inflammation after spinal surgery and~     decrease the need for post operative pain medication compared to intravenous patient~     controlled analgesia. Participants undergoing spine surgery will be randomized into one of~     two groups;~      - A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV~     infusion.~      B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative~     Patient Controlled Analgesia.~   "
207812|NCT00840983|"~     The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds~     would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better~     motor function at 40 wks and 7 months of age.~   "
207813|NCT00840957|"~     Infliximab is a chimeric monoclonal antibody directed towards Tumor Necrosis Factor -alpha~     that is largely used in inflammatory diseases such as rheumatoid arthritis (RA).~      A relationship between dose and clinical outcomes was shown in populations of RA patients but~     there is an interindividual variability of this relationship. At an individual level, this~     dose-effet relationship can be separated into the dose-concentration (pharmacokinetic or PK)~     and the concentration-effet (pharmacokinetic-pharmacodynamic or PK-PD) relationships.~      Serum trough concentrations of infliximab have been shown to be variable between patients~     receiving the same treatment regimen. This PK variability may be explained by several factors~     (e.g. genetic and immunological factors). The concentration-effect relationship may also be~     variable and the sources of this variability need to be studied as well. To date no detailed~     infliximab PK analysis has been published. The sources of variability of the dose-effect~     relationship need to be characterized to optimize infliximab dosing regimen in patients.~      The FAKIR study is a multicenter prospective observational study that will focus on patients~     treated with infliximab. Its aims are:~        1. to characterize the PK and PK-PD variability of infliximab in RA, using clinical~          criteria and biomarkers, assessed over time ;~        2. to study the influence of the polymorphism of FCGRT (the gene encoding FcRn) on the PK~          variability of infliximab; to study the influence of the polymorphism of FCGR3A (the~          gene encoding Fc gamma RIIIa) on the PK-PD variability of infliximab; and to study the~          influence of antibodies toward infliximab on the PK and PK-PD variabilities of~          infliximab.~   "
207814|NCT00840944|"~     Estrogens are responsible for the disappearance of growth cartilage in the long bones at the~     end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that~     stopping pubertal development and hence estrogen production, will prolong and increase the~     pubertal growth spurt, especially when growth hormone is given concommitantly.~      Boys in early puberty, with a bone age between 11 and 13 years and a predicted adult height~     below 163 cm or girls in early puberty with a bone age between 10 and 12 years and a~     predicted height under 151 cm will be treated with triptorelin 3.75 mg and Zomacton growth~     hormone for 4 years.~   "
207815|NCT00840931|"~     The purpose of this study is to find out the maximum tolerated dose (MTD) of the combined~     therapy of lenalidomide (Revlimid®) and Granulocyte/macrophage colony stimulating factor and~     CD40 Ligand expressed in the K562 cell line (GM.CD40L) bystander vaccine. This research is~     also being done to see how well the combination of these drugs works to fight myelodysplastic~     syndrome (MDS).~   "
207816|NCT00840918|"~     This study is being done to determine if lidocaine, administered during surgery and for 24~     hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation~     and 30 day mortality after surgery. Participants undergoing cardiac surgery will be~     randomized to receive either lidocaine or placebo.~   "
207817|NCT00840905|"~     This is a study to determine what Human Papillomavirus HIV seropositive women in Botswana,~     South Africa and Brasil have been exposed to during their life. The Human Papillomavirus~     causes cervical cancer. Different types are more likely to lead to cancer than other types. A~     vaccine has been made to fight infection against HPV 16 and 18 which has been shown to cause~     cervical cancer in America and Europe. What HPV type cause cancer in other countries is not~     as well studied.~      Hypothesis HPV serology will demonstrate that exposure to each HPV type in Gardisil~     (6,11,16,18) will be <50% in HIV seropositive women in resource limited countries.~   "
207895|NCT00839852|"~     This is an outpatient study to evaluate the long-term safety, tolerability, and~     pharmacokinetics of cariprazine in patients with Schizophrenia.~   "
207930|NCT00839384|"~     The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and~     clinical performance of the Advisa DR Implantable Pulse Generator (IPG).~   "
207818|NCT00840892|"~     There is growing evidence that COPD is a multi-organ system disease. Besides impaired lung~     function, skeletal muscle weakness and weight loss are important determinants of impaired~     exercise performance, decreased quality of life and increased mortality. Based on earlier~     succesful intervention studies in pulmonary rehabilitation settings, Máxima Medical Centre~     developed an integrated, inter-disciplinary approach to the management of COPD including~     physical exercise, nutritional therapy, education, smoking cessation and psychological~     consultation. This COPD management program consists of a set of protocols that cover patient~     recruitment, diagnostic testing, treatment, follow-up and communication between~     professionals.~      The exercise program and the nutitional therapy are carried out by local physiotherapists and~     dieticians working outside but in conjunction with the hospital. A program in such a setting~     could be substantially less expensive and certainly more easily accessible for many more~     patients than an inpatient or hospital-based outpatient rehabilitation program, as it is~     offered close to a patient's home. This study investigates the (cost-)effectiveness of the~     COPD management program compared to usual care in a randomized controlled trial.~      Patients with moderate to severe COPD and a reduced exercise capacity during an incremental~     exercise test of less than 70% of predicted, are randomised to a treatment or a control~     group. The treatment group will participate in the COPD management program during the first 4~     months after which they will be followed up for the remaining months. Both groups (n=100) are~     followed for 2 years and outcomes will be assessed at the beginning of the program, after 4,~     12 and 24 months by disease-specific and generic measures of health status, body composition,~     skeletal muscle function and exercise capacity. A cost-effectiveness and cost-utility~     analysis with a two-year time horizon will be performed. The analysis is conducted from a~     societal perspectice, including the program costs and all COPD-related direct costs within~     and outside the healthcare sector ans costs of lost productivity.~   "
207819|NCT00840879|"~     The objective of this study is to compare the rate and extent of absorption of meloxicam from~     a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under~     fed conditions.~   "
207820|NCT00840866|"~     The objective of this study is to compare the relative bioavailability of cefprozil 500 mg~     tablets with that of Cefzil 500 mg tablets in healthy, non-smoking adults under non-fasting~     conditions.~   "
207821|NCT00840853|"~     Subjects are having a bone marrow or SCT for either a type of cancer of the blood called~     Leukemia or a cancer of the lymph nodes called non- Hodgkin's Lymphoma. Although a transplant~     can cure leukemia or lymphoma, some people will relapse. In those who relapse, current~     treatment cures only a very small percentage. Although giving patients a dose of donor immune~     cells before relapse can prevent relapse of the leukemia or lymphoma, DLI can also cause a~     serious complication called graft versus host disease (GVHD). This is a gene transfer~     research study using special immune cells which are specific for these cancer cells.~      The body has different ways of fighting infection and disease. This study combines 2 of those~     ways, antibodies and T cells. T cells (CTLs or cytotoxic T cells) are infection-fighting~     blood cells that can kill cells, including tumor cells. Antibodies and T cells have been used~     to treat patients with cancers; they have shown promise, but haven't been strong enough to~     cure most patients.~      The antibody used in this study is called anti-CD19. This antibody sticks to leukemia cells~     because of a substance on the outside of these cells called CD19. For this study, the~     anti-CD19 antibody has been changed so that instead of floating free in the blood it is now~     joined to T cells. When an antibody is joined to a T cell in this way it's called a chimeric~     receptor.~      In the laboratory, investigators found that T cells that are trained to recognize common~     viruses can stay in the blood stream for many years. By joining the anti-CD19 antibody to~     CTLs that recognize viruses, they believe that they will also be able to make a cell that can~     last a long time in the body, provide protection from viruses, and recognize and kill~     leukemia. The CTLs which we will join the anti-CD19 antibody to attack 3 viruses~     (trivirus-specific CTLs), CMV, EBV, and adenovirus.~      CMV is a virus that rarely causes problems in healthy people but can cause serious infections~     in patients with suppressed immune systems. It can cause a very serious pneumonia, and can~     also affect the intestinal tract, liver and eyes. 2/3 of normal people harbor this virus in~     their body. If the subject or donor are positive for CMV, the subject is at risk of~     developing CMV disease after transplant. EBV causes mononucleosis or mono (infection with~     fatigue, high fever, and swollen lymph nodes). It is normally controlled by a healthy immune~     system but when the immune system is weak after bone marrow transplant it can cause fevers,~     enlarged lymph nodes and a type of cancer called lymphoma. Adenovirus is a virus that causes~     symptoms of a common cold but can cause life-threatening infections in patients with weak~     immune systems.~      Studies have shown that trivirus-specific CTLs grown from the stem cell donor can be given~     safely to transplant recipients and can stop these viruses from causing severe infections.~     These CD19 chimeric receptor trivirus specific T cells are an investigational product not~     approved by the FDA.~      The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to~     assess the side effects, to see how long the T cells last and to evaluate whether this~     therapy might help prevent infections and relapse in people with CD19+ leukemia or lymphoma~     having a SCT.~   "
207822|NCT00840840|"~     The purpose of this study is to assess the bioequivalence between Amoxicillin/Clavulanate~     Potassium Oral Suspension 600/42.9 mg/5 mL and Augmentin ES-600 Oral Suspension, 600/42.9~     mg/5 mL in healthy, male and female subjects, under fed conditions.~   "
207823|NCT00840827|"~     Lenalidomide has shown significant efficacy in the treatment of anemia associated with both~     5q- and non 5q- MDS patients. The mechanism(s) of action of lenalidomide in MDS is still to~     be determined, but given the differences in response rates seen, it is probable that the~     mechanism is different for patients with 5q- disease compared to non 5q- patients. T-cell~     mediated activation of intramedullary apoptosis in patients with early MDS leading to~     impaired hematopoiesis has been well described. Immunomodulation with agents such as ATG,~     cyclosporine and thalidomide have demonstrated clear activity in some patients with MDS.~     Lenalidomide, among its many effects, is a potent immunomodulator, which may contribute to~     its ability to improve red blood cell counts in patients with MDS. It is possible that this~     effect could be augmented with the addition of cyclosporine A (CSA), in a similar manner to~     CSA effects in patients with other bone marrow failure syndromes such as aplastic anemia.~      Subjects will be treated with lenalidomide 10 mg PO daily days 1-28 of a 28-day cycle.~     Cyclosporine A will be started on day 1 of cycle 2 (day 29) at a dose of 5 mg/kg per day~     given orally in 2 divided doses. Cyclosporine A levels will be assessed weekly and doses will~     be adjusted to maintain a serum trough level between 100-450 mg/ml. Patients will continue on~     therapy for minimum of 16 weeks unless toxicity occurs which precludes continuation on~     therapy, disease progression and/or patient withdrawal of consent. Patients not achieving~     response after completing 16 weeks of therapy will discontinue treatment. Patients achieving~     response will continue therapy until disease progression, unacceptable toxicity or loss of~     response.~   "
207824|NCT00840814|"~     RATIONALE: Developing a symptom checklist for late-effect lymphedema may help doctors learn~     more about lymphedema in patients with head and neck cancer and plan the best treatment.~      PURPOSE: This phase I/II trial is developing a checklist of lymphedema symptoms in patients~     with head and neck cancer.~   "
207825|NCT00840801|"~     The objective of this study is to assess the immunogenicity, safety and interchangeability of~     two different TBE vaccines in children aged 1-11 years, the first and second vaccination with~     either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with~     FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28~     and 360 days).~   "
207826|NCT00840788|"~     Surgical repair of perineal lesions after delivery is frequently associated with pain and~     discomfort interfering with the normal activities of the puerperium. The aim of this study~     was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular~     suture, regarding the incidence of pain and wound complications.~   "
207827|NCT00840775|"~     The purpose of this study is to collect and analyze additional information about the safety~     and effectiveness of the Presillion™ Stent System in the treatment of de novo stenotic~     lesions in native coronary arteries.~   "
207828|NCT00840762|"~     The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to~     those provided by local expert review. The investigators propose that clinic patients of the~     Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized~     in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method~     will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time~     point equal to or greater than 2 months and 6 months following the change in antiretroviral~     medications following the testing~   "
207829|NCT00840749|"~     Lung cancer remains the most frequent cause of cancer death in both men and women in the~     world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling~     has been a standard of care for operable early stage NSCLC. Several studies have reported~     high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted~     treatment for medically inoperable patients with stage I NSCLC and patients with operable~     stage I lung cancer are entered on clinical protocols. The purpose of this study is to~     conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current~     standard of care for stage I operable NSCLC.~   "
207830|NCT00840736|"~     The study aims to investigate the long term results of a randomized clinical single-centre~     trial comparing two standard operative techniques in bariatric surgery; laparoscopic~     adjustable gastric banding and vertical banded gastroplasty.~   "
208139|NCT00836628|"~     This protocol is aimed at establishing a maximum tolerated dose (MTD) for submyeloablative~     doses of Busulfex ® with the hope that a tolerable, submyeloablative dose can be established~     to test efficacy as alternative therapy for refractory pediatric brain tumors.~   "
207833|NCT00840697|"~     Low back pain is a usual condition in the western countries and several treatments available~     for patients with non-specific low back pain. According to the European guidelines both~     Brief intervention and exercise/cognitive intervention are effective treatments with regard~     to pain and function (www.backpaineurope.org), but none have documented effect on return to~     work.~      The challenges for health personnel is not cure of the patients back pain, but to build up~     rehabilitation programs which focus on disability and work incapacity, in patients which are~     at risk of loosing their work. Dr. P. Loisel, Montreal, Canada, has since 1995 treated~     patients with back pain according to the The PREVICAP model - (PREVention of work~     handICAP), where the main purpose with work-related program is to prevent prolonged~     disability and to help patients back to work. Loisel demonstrated that the PREVICAP models~     accelerated the return to work factor by a factor 2.4 (p=0.01). The PREVICAP model had also~     been evaluated in Amsterdam, by Dr. Anema with the same results.~      At the Back Clinic, Ullevål University Hospital we are presently involved in a randomized~     controlled trial after the PREVICAP model, where patients are randomized to Brief~     intervention including a work-related intervention or usual care. All included patients in~     both groups, will have a clinical examination by specialist in Physical Medicine and~     Rehabilitation and advice from a physiotherapist. The current study replaces Brief~     intervention with an exercise - and a work-related program, so patients with non-specific LBP~     will be randomized to an exercise and work-related program or usual care.~      The main purpose of this study~        -  to investigate if rehabilitation programs specifically focusing on the return to work~          process will reduce sickness absence and disability pension in patients with neck and~          low back pain.~        -  to assess the work-, individual- and health factors and their interrelationship~          predicting sickness absence and work disability.~        -  to compare results from the rehabilitation program with results from rehabilitation~          program in Toronto~        -  to which extent are the patients met by actions from employers and employment services,~          and does is influence sickness absence and disability.~        -  do these actions represent favourable cost benefit for the work places and the society~   "
207834|NCT00840684|"~     RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of laromustine when~     given together with daunorubicin and cytarabine in treating patients with acute myeloid~     leukemia.~   "
207835|NCT00840671|"~     It should be shown that Cerebrolysin in combination with Alteplase, the medication that~     should recover the blood flow through the brain, is an effective and save medication to treat~     ischeamic stroke.~   "
207836|NCT00840658|"~     The investigators propose a highly efficient four-arm (factorial) trial to simultaneously~     test the efficacy of two behavioral interventions aimed at:~        -  increasing condom use in the context of ongoing drug use and~        -  decreasing needle and paraphernalia sharing~      among female sex workers who also inject drugs in two Mexican-U.S. border cities: Tijuana and~     Ciudad Juarez.~   "
207837|NCT00840645|"~     The study is intended to test the safety, tolerability, and efficacy of long-term treatment~     with YM178 in patients with overactive bladder symptoms.~   "
207838|NCT00840632|"~     The objective of this study is to compare the rate and extent of absorption of trandolapril~     from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4 mg Tablets~     under fasting conditions.~   "
207839|NCT00840606|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg~     Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg~     BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg~     tablet) in healthy adult volunteers under fasting conditions.~   "
207840|NCT00840593|"~     The purpose of this study is to compare the long-term clinical and radiological results of~     operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation.~   "
207841|NCT00840580|"~     The purpose of this study was to compare the effects of Vigamox and Cravit on corneal wound~     healing after cataract surgery.~   "
207842|NCT00840567|"~     The investigators plan to obtain skin and blood samples from healthy volunteers and patients~     with a benign, inherited hematologic disease to use for research to use homologous~     recombination to correct β-globin gene mutations in therapeutically useful cells, like~     autologous induced pluripotent stem cells from sickle cell anemia patients.~   "
207843|NCT00840554|"~     The purpose of this study is to find out if adding a home exercise program to a clinic~     physical therapy program will improve the fatigue experienced by patients being treated with~     concurrent chemotherapy and radiation therapy for high grade gliomas.~   "
207844|NCT00840541|"~     The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy~     (DR) progression based on available clinical data (demographic, systemic and ophthalmic~     data).~   "
207845|NCT00840528|"~     The principal purpose of this study is to identify hyper-responsive, responsive and~     non-responsive groups of healthy human subjects based on their airway neutrophilic response~     to ozone exposure, and to perform micro-array analyses on DNA collected from recovered airway~     cells to explore possible differences in gene expression profiles between the three groups~   "
207846|NCT00840515|"~     A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the~     prevention of radiation induced dermatitis.~   "
207847|NCT00840502|"~     Most of the neonatal deaths that occur worldwide every year are associated with low birth~     weight (LBW), caused by intrauterine growth restriction (IUGR) and/or preterm delivery.~     Accurate assessment of fetal growth and gestational age for timely identification and~     management of growth restriction are therefore public health priorities, especially in~     developing countries where 98% of all neonatal deaths occur. Every year, more than 50 million~     women become pregnant in malaria endemic regions. Malaria infection at any time during~     pregnancy reduces birthweight. However, little is known about the relationship between the~     timing of infection during pregnancy and the extent of the impact on birth weight. The~     mechanisms by which malaria causes LBW also remain unclear. Reduced placental blood flow,~     placental changes, red blood cell changes, severe anaemia and pro-inflammatory cytokines have~     all been implicated.~      In this proposed, longitudinal, observational, minimal risk study, which will take place in~     SMRU antenatal clinics on the Thai-Burmese border, the effect of malaria infection during~     pregnancy on fetal growth will be determined. Women will be screened before 13+6 weeks of~     gestation and followed with regular ultrasound examinations during pregnancy. When a woman~     has a malaria infection an extra ultrasound scan will be done to measure growth retardation~     or placental blood flow changes. Bloodsamples will be taken to detect changes in red blood~     cell properties and putative markers of malaria infection. For this study the maximum amount~     of blood taken during pregnancy is 13 cc in an uninfected woman. For each malaria episode an~     additional 7 cc blood will be taken. After delivery a placenta and a cord sample will be~     taken to detect placental changes. The investigators aim to recruit four hundred pregnant~     women over the course of two years. This study involves minimal risk to participants as~     ultrasound examination is part of routine antenatal care in many countries in the world.~   "
207896|NCT00839839|"~     University Reproductive Associates is conducting a pilot study to study the technique of egg~     freezing. Your participation in this study will provide us with important information to~     allow us to offer this technology for women wishing to freeze their eggs before cancer~     treatments. Your participation will include a standard IVF cycle with your eggs being frozen~     for a brief period of time and then transferred back to you as usual. You will receive a~     significant reduction in your IVF cycle cost.~   "
207848|NCT00840489|"~     The rate of sustained virological response to a course of standard antiviral therapy~     (peg-interferon plus ribavirin) of patients with chronic hepatitis C infected by genotype 1~     with advanced fibrosis (>F2) is rather low. Monotherapy with ribavirin reduces ALT levels and~     necroinflammatory liver activity in up to a half of non-responders to standard antiviral~     therapy, but without changes in liver fibrosis or viremia. Such a beneficial effect seems to~     be mainly due to the immunomodulatory effect of ribavirin. Portal pressure, as measured by~     HVPG, lowers in patients with chronic hepatitis C and advanced fibrosis with end-of-treatment~     response to peg-interferon plus ribavirin. Portal pressure reduction in this setting relates~     to a reduction of the necroinflammatory liver activity, but not with fibrosis amelioration.~     We hypothesize that monotherapy with ribavirin reduces portal pressure in hepatitis C~     patients with advanced fibrosis by means of its immunomodulatory and anti-inflammatory~     effects, and could constitute an alternative to non-responders to standard antiviral~     treatment. Portal pressure measurement has become a validated surrogate outcome measure in~     chronic liver disease, since decreasing portal pressure has shown consistent improvement in~     survival and clinical outcomes, such as complications of portal hypertension. The primary aim~     of this study is to investigate whether ribavirin monotherapy slows the progression of~     advanced chronic liver disease by hepatitis C as assessed by a reduction in HVPG.~   "
207849|NCT00840476|"~     The objective of this study is to compare the rate and extent of absorption of meloxicam from~     a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under~     fasting conditions.~   "
207850|NCT00840463|"~     This is a randomized study of ambrisentan that will last 16 weeks. The study will include~     patients with diastolic heart failure and pulmonary hypertension. Patients will be randomized~     (1:1) to ambrisentan or placebo. The ambrisentan or matching placebo will be started at 2.5~     mg by mouth daily and increased to 5mg and then 10mg daily, if tolerated. Patients will be~     seen at least monthly for 16 weeks. Adverse reactions will be reviewed and the required~     monthly laboratory tests (liver function testing and pregnancy testing, if applicable), will~     be performed. Patients will also complete an exercise test (six minute walk distance) and a~     quality of life survey at the baseline, week 4 and week 16 visit. An echocardiogram and a~     right heart catheterization and left ventricular end diastolic pressure measurement will be~     performed at the 16 week visit. The primary end-point is safety, and secondary end-points~     include the catheterization results, echocardiogram results, the walk distance and the~     quality of life survey. The expected completion of the study is 18 months from initiation.~     Ambrisentan is an FDA approved drug for PAH, but not for CHF.~   "
207851|NCT00840450|"~     This study is designed to determine whether the combination treatment of Paclitaxel and~     Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will~     generate better clinical response than Paclitaxel alone.~   "
207852|NCT00840437|"~     The health and well being of patients with refractory angina will be assessed using validated~     questionnaires (SF-36 and Seattle Angina Questionnaire [SAQ]) at baseline and one year.~   "
207853|NCT00840411|"~     The objective of this study is to compare the relative bioequivalence of a test~     clarithromycin extended release formulation to an equivalent oral dose of the commercially~     available extended release clarithromycin in a test population of 66 adult subjects under~     fasting conditions.~   "
207854|NCT00840398|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg~     Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg~     BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg~     tablet) in healthy adult volunteers under non-fasting conditions.~   "
207855|NCT00840385|"~     The primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin~     and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas~     (PTCL). 30 patients will be treated into this study.~   "
207856|NCT00840372|"~     The aim of this observational study in patients chronically hemodialyzed by a native~     arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the~     quality of the punction. The investigators have observed that cannulation with blunt needles~     (button-hole method) is sometimes difficult and the use of a sharp needle may be necessary,~     with consequently more hematomes and infections. Our hypothesis is that canulation with~     semi-blunt needles would be easier than with classical blunt needles, and consequently the~     use of sharp needles would become less frequent.~      Inclusion criteria and study design are detailed below.~   "
207857|NCT00840359|"~     The aim of the project is to determine whether daylight activated photodynamic therapy is~     effective in treating cutaneous leishmaniasis caused by L. major and L. tropical.~      PDT is classically performed as a two-step procedure in which MAL application to the lesion~     constitutes the first step, and PpIX activation by light of appropriate wavelength from an~     artificial light source constitutes the second step. Based on the knowledge that red and blue~     light required to activate PpIX are part of the daylight spectrum, the investigators~     postulated that effective PpIX activation can be obtained by exposure of the MAL treated~     lesions to daylight thus substantially simplifying the PDT procedure by omitting the 3 hour~     incubation period and the subsequent exposure to artificial light. In accord, in a recent~     study the investigators showed that daylight-activated PDT (DA-PDT) was as effective as~     conventional MAL-PDT in treating precancerous actinic keratoses lesion. Furthermore the~     investigators found that DA-PDT is significantly less painful than conventional MAL-PDT.~      The investigators now propose to study the efficacy of DA-PDT in the treatment of cutaneous~     leishmaniasis. DA-PDT has obvious advantages to conventional leishmania treatment forms:~      As opposed to most of the available treatment options, DA-PDT is a self-administered~     procedure that does not require the assistance of medical personnel. Secondly, judged by our~     experience with MAL-PDT, only few treatment sessions are required for effective parasite~     killing as opposed to the prolonged procedures usually required for treatment of~     leishmaniasis. Third, PDT has the far the best safety profile of all available treatment~     options.~   "
207858|NCT00840346|"~     This protocol is a multicenter, national, open-label, single-arm, non-controlled study~     designed to establish the efficacy (in terms of response and survival) and safety of~     panobinostat in combination with idarubicin and cytarabine and in monotherapy in patients~     with newly-diagnosed AML aged 65 years or older.~   "
207912|NCT00839631|"~     This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric~     coated D-3263 HCl in subjects with advanced solid tumors~   "
207859|NCT00840333|"~     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory~     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which~     has been particularly problematic to eradicate and been implicated as the major cause of~     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung~     increases the local concentrations of antibiotic at the site of infection resulting in~     improved antimicrobial effects compared to systemic administration. Bacterial resistance to~     current aerosol antibiotic treatments indicate a need for improved therapies to treat CF~     patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and~     other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to~     have antimicrobial effects on even the most resistant organisms. MP-376 is a novel~     formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery~     using the PARI electronic eFlow® nebulizer. Preclinical and early clinical studies in adults~     show that aerosol doses of MP-376 appear to be safe and well tolerated, and exert an~     antimicrobial effect when administered once or twice daily. High concentrations of~     levofloxacin in the lung delivered using MP-376 are expected to be active against CF~     pathogens such as P. aeruginosa and S. aureus, including those resistant to aminoglycosides~     (such as TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered~     rapidly and efficiently using the PARI eFlow® nebulizer system. This Phase 1 study is being~     performed to obtain safety, tolerability and PK data in children ages 6-16 in order to~     determine if MP-376 is safe, prior to enrolling children of these ages in the planned pivotal~     Phase 3 studies.~   "
207860|NCT00840320|"~     The purpose of this study is to characterize the safety and tolerability of repeat doses of~     compound 1278863A in healthy subjects.~   "
207861|NCT00840307|"~     This study evaluates how ectopic fat (in the pancreas, heart, liver and skeletal muscle),~     visceral fat, and subcutaneous fat changes following surgically induced weight loss using~     gastric banding. The investigators also evaluate whether changes in pancreatic fat content~     correlate with improvement in beta-cell function.~   "
207862|NCT00840294|"~     The purpose of this study is to assess the impact of an empiric course of antibiotics for men~     with an elevated prostate-specific antigen (PSA) level.~   "
207863|NCT00840281|"~     The objective of this study is to compare the relative bioavailability of cefprozil 500 mg~     tablets (Teva Pharmaceuticals USA) with that of Cefzil® 500 mg tablets (Bristol-Myers Squibb)~     in healthy, non-smoking adults under fasting conditions.~   "
207864|NCT00840268|"~     The purpose of this study is to demonstrate efficacy of Hydroxypropyl Guar Galactomannan~     0.25% (HPGG) ophthalmic gel compared to Vehicle for the treatment of dry eye.~   "
207865|NCT00840255|"~     The purpose of this study is to adapt and test the effects of a 4-week behavioral treatment~     that targets chronic insomnia (lasting >1 month) in service members returning from Operation~     Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), finalizing a treatment manual.~   "
207866|NCT00840242|"~     The purpose of this study is to test the success rate of smoking reduction or cessation with~     different nicotine products.~   "
207867|NCT00840229|"~     The purpose of this study is to compare ultrasound guided capsular corticosteroid injection~     into the rotator interval/anterior capsule and the GH joint with ultrasound guided~     corticosteroid injection into the GH joint only. Both methods will be compared with placebo~     injections.~      Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of~     function (SPADI, Life quality, ROM).~      0-hypothesis: no difference between the methods.~      The investigators want to find out if the clinical effect of the combined capsular and~     intra-articular injections are better than placebo and better that intra-articular injections~   "
207868|NCT00840216|"~     The objective of this study is to compare the relative bioequivalence of a test~     clarithromycin extended release formulation to an equivalent oral dose of the commercially~     available extended release clarithromycin in a test population of 22 adult subjects under fed~     conditions.~   "
207869|NCT00840203|"~     The objective of this study is to evaluate the relative bioavailability of the test~     formulation of mesalamine suspension rectal enema with the already marketed reference~     formulation Rowasa® in healthy, adult subjects.~   "
207870|NCT00840190|"~     This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects~     with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies~     will be included. This is a dose escalation study following an accelerated titration design.~     It is expected that around 50 subjects would be enrolled in the study.Safety assessment will~     be conducted on the basis of vital signs, physical examination and laboratory investigations~     undertaken at regular intervals as per the schedule.~   "
207871|NCT00840177|"~     RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by~     making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together~     with pravastatin may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together~     with pravastatin works in treating patients with relapsed acute myeloid leukemia.~   "
207872|NCT00840164|"~     1. To explore the pathology of nerve, vascular, and skin in the amputated leg~        2. To diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the~          skin intervention~        3. To search for (1) mechanisms of amputation and (2) prevention measures for further~          amputation in the currently healthy-looking limb~   "
207913|NCT00839605|"~     The purpose of this study is to evaluate the effects of Dexmedetomidine when used during~     thoracic surgery.~      The primary outcome will be changes in oxygenation as measured the PaO2 during one lung~     ventilation.~   "
207914|NCT00839592|"~     This is a randomized controlled trial to evaluate acupuncture treatment on insomnia in the~     adult population in Hong Kong.~   "
207931|NCT00839371|"~     Bronchoscopy is performed on a daily basis for diagnostic and therapeutic purposes. This~     procedure may cause anxiety and discomfort requiring the use of sedative drugs.~      In this study the investigators titrate the administration of sedatives using bispectral~     analysis of the EEG. The investigators compared 2 drugs, propofol versus midazolam regarding~     patient subjective tolerance, recovery of brain function, safety and operator's satisfaction.~   "
207873|NCT00840151|"~     The purpose of this study is to compare different forms of treatment for substance abuse.~     This study will involve a type of treatment called contingency management, in which patients~     receive incentives (prizes) for attending outpatient treatment. This study will compare~     contingency management to standard treatment that does not involve incentives. This study~     will also compare contingency management treatment that lasts 6 weeks to contingency~     management that lasts 12 weeks. Finally, this study will compare contingency management~     treatment delivered at the beginning of outpatient treatment to contingency management~     treatment delivered later during outpatient treatment. The investigators hypothesize that (1)~     a 12-week attendance-based contingency management intervention will improve retention and~     enhance drug abstinence versus standard treatment, (2) initial short-term exposure to~     attendance-based contingency management (in weeks 1-6 only) will improve substance abuse~     treatment outcomes compared to standard treatment alone, and (3) contingency management in~     weeks 7-12 will be particularly useful for those with sporadic attendance or continued drug~     use during initial stages of treatment.~   "
207874|NCT00840138|"~     In this prospective study the investigators compared common bile duct injuries (CBDI)~     following laparoscopic cholecystectomy (LC) and open cholecystectomy (OC) procedures, 35~     patients in each group. To date, no detailed study concerning this matter has been published.~     LC - CBDI in comparison with OC - CBDI more often concerned young females with a narrow CBD,~     they were located closer to the liver hilus, and they were more extended.~   "
207875|NCT00840125|"~     Study Rationale:~      There is increasing evidence that erlotinib improves overall survival in selected patients~     with stage IIIB-IV NSCLC. Furthermore, pre-clinical and phase II studies have shown a~     potential for synergism between erlotinib and docetaxel. This study will further evaluate the~     effects of combination treatment on overall survival in selected NSCLC patient population.~      Based on recent published data, the treatment cycle in this study will be 22 days with two~     infusions (Day 1 and Day 8 of each cycle). This is different from the standard therapy care~     of 28-day cycle (three infusions on Days 1, 8 and 15). The shorter 22-day cycle was shown to~     be just as effective as the 28-day cycle and is expected to increase subject compliance and~     decrease chemotherapy-induced toxicity.~      Study Objectives:~      The primary objective is to demonstrate superiority in progression-free-survival, when~     erlotinib is added to docetaxel.~      The secondary objectives are to determine:~        -  Overall survival (defined as the time period from the start of first-line therapy to~          death)~        -  Time to treatment failure or disease progression (defined as the time period from the~          start of first-line therapy to investigator assessed disease progression)~        -  Tumor response rate and duration~        -  Safety profile~        -  Quality of Life improvement~        -  microRNA profile (assessed from human lung biopsy and/or cytology samples) at screening~          for prognostic purposes~   "
207876|NCT00840112|"~     Purpose:~      People with a genetic defect in the ability to burn fat can also develop a problem with the~     nerves in their feet. The nerve problem, or neuropathy, can limit their ability to walk. Part~     of the treatment of their genetic defect in the ability to burn fat is to eat a very low fat~     diet. Vitamin E is found only in fatty foods like oils and nuts. People with a genetic defect~     in the ability to burn fat may have low vitamin E because of their low fat diet. The purpose~     of this study is to test whether vitamin E supplements can improve the nerve function in the~     feet of people with a genetic defect in the ability to burn fat.~      Procedures:~      Blood samples will be drawn at the beginning of the study, after 2 months and after 6 months~     of vitamin E supplements. The blood will be analyzed for plasma vitamin E concentrations.~     Around the time of each blood draw subjects will record all the food and beverages he or she~     consumes for three days. The subject will send the record to the investigator. Subjects will~     have a physical exam by a doctor specializing in nerves, a neurologist before and after~     taking vitamin E. They will have nerve function measured with a test called a nerve~     conduction velocity or NCV. Subjects will be given 800 international units (IU) of vitamin E~     per day for 6 months.~   "
207877|NCT00840099|"~     The objective of this study is to assess the bioequivalence between Amoxicillin and~     Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral~     Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions.~   "
207878|NCT00840086|"~     This trial is conducted in Asia, Europe, and North and South America. The trial consists of a~     main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog~     alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial~     investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding~     episodes during surgical procedures.~   "
207879|NCT00840073|"~     The objective of this study is to evaluate the comparative bioavailability between~     trandolapril 4 mg tablets (test) and Mavik® 4 mg Tablets (reference) after a single-dose in~     healthy subjects under fed conditions.~   "
207880|NCT00840060|"~     The goal of this proposal is to examine the efficacy of a manualized treatment intervention,~     AMALS: Addressing Multiple Aspects of Language Simultaneously, which is designed to remediate~     semantic, morphological, and syntactic aspects of language in preschool children with~     language impairment. This study will target preschool children with language impairment~     living in a region characterized by nonmainstream dialects.~      Questions driving this work are:~        1. Will children participating in the AMALS treatment exhibit greater semantic,~          morphological, and syntactic complexity on multiple outcome measures at the completion~          of the intervention compared to a Discrete Trial Approach (DTA) group?~        2. Will these gains be maintained at one-month follow up?~        3. What is the impact of dialect on dependent variables, specifically morphosyntactic~          abilities?~      To answer these questions a randomized clinical trial will be conducted comparing AMALS, an~     integrated approach to treatment, with DTA, an additive approach to therapy. In this study~     rather than restrict the ethnic and cultural backgrounds of this population, children's use~     of dialect will be uniquely identified and examined.~   "
207915|NCT00839579|"~     Exercise training is proved to protect against premature cardiovascular mortality.~     Additionally there is evidence that relatively high exercise intensity may be an important~     factor for improving aerobic capacity and endothelial function in patients with~     post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in~     overweight and obese individuals.~      The aim of this study is to investigate the amount of high-intensity exercise needed to~     improve aerobic capacity and endothelial function.~   "
207881|NCT00840047|"~     The purpose of this study is to test the usefulness of imaging with radiolabeled methionine~     in the evaluation of children and young adults with tumor(s). Methionine is a naturally~     occurring essential amino acid. It is crucial for the formation of proteins. When labeled~     with carbon-11 (C-11), a radioactive isotope of the naturally occurring carbon-12, the~     distribution of methionine can be determined noninvasively using a PET (positron emission~     tomography) camera. C-11 methionine (MET) has been shown valuable in the monitoring of a~     large number of neoplasms. Since C-11 has a short half life (20 minutes), MET must be~     produced in a facility very close to its intended use. Thus, it is not widely available and~     is produced only at select institutions with access to a cyclotron and PET chemistry~     facility. With the new availability of short lived tracers produced by its PET chemistry~     unit, St. Jude Children's Research Hospital (St. Jude) is one of only a few facilities with~     the capabilities and interests to evaluate the utility of PET scanning in the detection of~     tumors, evaluation of response to therapy, and distinction of residual tumor from scar tissue~     in patients who have completed therapy. The investigators propose to examine the~     biodistribution of MET in patients with malignant solid neoplasms, with emphasis on central~     nervous system (CNS) tumors and sarcomas. This project introduces a new diagnostic test for~     the noninvasive evaluation of neoplasms in pediatric oncology. Although not the primary~     purpose of this proposal, the investigators anticipate that MET studies will provide useful~     clinical information for the management of patients with malignant neoplasms.~   "
207882|NCT00840034|"~     The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an~     adjunctive treatment for participants with major depressive disorder (MDD), who were~     identified as partial responders to an adequate course of treatment with a selective~     serotonin reuptake inhibitor (SSRI) (as defined by history).~   "
207883|NCT00840008|"~     The purpose of this study is to assess whether adherence to NVUGIB guidelines is improved~     with implementation of a national, tailored multifaceted intervention. Outcomes include~     adherence rates to two key endoscopic and pharmacological therapy guidelines together~     (primary), or adherence to these individually as well as to other recommendations~     (secondary). Patient outcomes and economic data are also assessed (tertiary).~   "
207884|NCT00839995|"~     The purpose of this study is to obtain coagulation profiles of patients undergoing~     multi-level spine surgeries with ROTEM® and routine coagulation tests. The investigators will~     compare the data from ROTEM® and routine coagulation tests with each other and with blood~     loss and transfusion therapies used.~   "
207885|NCT00839982|"~     This phase I/II trial studied the side effects and best dose of clofarabine when given~     together with cytarabine and to see how well they work in treating older patients with acute~     myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) that have relapsed or not~     responded to treatment.~   "
207886|NCT00839969|"~     Urethral dilatation is a commonly undertaken intervention for a variety of urinary complaints~     including overactive bladder symptoms. There is however very little evidence for its~     efficacy, and no randomized trial evidence. The aim of this study is to ascertain the effect~     of urethral dilatation on overactive bladder symptoms and on voiding parameters. The null~     hypothesis is that there will be no difference in symptoms or voiding parameters between the~     urethral dilatation and sham groups.~      Eligible women will be assessed initially with a history and examination, a King's Health~     Questionnaire and Bristol Female Urinary Tract Symptoms (BFLUTS) questionnaire and pressure~     flow studies. They will be randomized to undergo either cystoscopy alone or cystoscopy and~     urethral dilatation. Patients will be blinded to the procedure undertaken and randomized~     using a series of opaque envelopes. Follow up will be at 6 weeks with repeat questionnaires~     and pressure flow studies. Subjective and objective outcomes will be compared between the two~     groups.~   "
207887|NCT00839956|"~     This phase II trial studies the side effects of giving bortezomib together with vorinostat~     and to see how well it works in treating patients with multiple myeloma who have undergone~     autologous stem cell transplant. Bortezomib and vorinostat may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with~     vorinostat after an autologous stem cell transplant may stop the growth of any cancer cells~     that remain after transplant.~   "
207888|NCT00839943|"~     The purpose of this study is to compare the effect of ozone exposure on airway reactivity and~     inflammation in obese vs. non-obese adults.~   "
207889|NCT00839930|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 50 mg~     Cilostazol Tablets manufactured by TEVA Pharmaceuticals Industries Ltd. and distributed by~     TEVA Pharmaceuticals USA with that of PLETAL Tablets manufactured by Otsuka Pharmaceuticals~     Co., Ltd. for Otsuka America Pharmaceutical, Inc. following a single oral dose (1 x 50 mg~     tablet) in healthy adult subjects administered under fasting conditions.~   "
207890|NCT00839917|"~     This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™~     with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested~     is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after~     vaccination with ProQuad™ will be non-inferior to the antibody response rates after~     vaccination with concomitant M-M-R™ II and Varivax™.~   "
207891|NCT00839904|"~     Physical activity is a well-known and powerful tool in medicine,having preventive,~     palliative, and curative properties. This has not been sufficiently examined in children in~     remission from cancer. In this study, children in remission from cancer will be divided into~     exercise and control groups. The interventional group will perform two supervised, 60-minute~     weekly exercise sessions. Outcome measures of the exercise intervention will be quality of~     life, mood, cardiorespiratory fitness, body composition and bone mineral density.~   "
207892|NCT00839891|"~     -  Determine whether VI-0521 has an effect on the electrical activity of the heart in~          healthy subjects.~        -  Find out how much VI-0521 is in the blood and any potential side effects on ECG's of~          healthy subjects after taking the study drugs.~   "
207893|NCT00839878|"~     This study is conducted in Asia. The aim of this observational study is to evaluate current~     status of diabetes management, control, complications in diabetic subjects in Asia.~   "
207894|NCT00839865|"~     The purpose of this study is to determine if dressing change with a kind of herb Yuyang~     ointment is clinically more efficacious and safer than Conventional treatment in the~     treatment of diabetic foot ulcers.~   "
207897|NCT00839826|"~     Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to~     60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as~     heparins, significantly lowers that risk, but heparins have to be applied below the skin~     (subcutaneously). Additionally, there is a chance of developing a heparin-induced~     thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents~     which are safer and more efficient and which are easier to apply.The purpose of this study is~     to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the~     licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and~     widely used in the area of thromboprophylaxis and will be given once daily~     subcutaneously.Another important purpose of the study is to find the optimal dose of BAY~     59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several~     dose steps planned.~   "
207898|NCT00839813|"~     The central question in this research proposal is: can a popular technique that specifically~     targets active mastery and improved affect regulation, yoga, which is utilized by~     approximately 4% of the US population each year (1), improve the constellation of PTSD~     symptoms, multiple somatic complaints, social and occupational impairment and high health~     care utilization that has been documented in hundreds of thousands of women in the US?~      The Primary Aims of this study include the following:~        1. To test the short-term and long-term effectiveness of 10 weeks of yoga for treating~          treatment-resistant PTSD and compare it with attention controls receiving Women's Health~          Education (WHE).~        2. To assess the short-term and long-term effects of yoga on a) co-morbid conditions, b)~          quality of life, c) body awareness, d) health care utilization and e) heart rate~          variability (HRV), in comparison to an attention control group.~   "
207899|NCT00839800|"~     The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort~     Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler~     160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma~     therapy~   "
207900|NCT00839787|"~     Surgeons are the individuals who will operate on a patient if it is determined to be~     necessary after they present with abdominal pain. For that reason, the investigators want to~     study if giving a medicine (morphine) to children presenting to the ED with abdominal pain~     will alleviate pain without changing the patient's physical exam and the subsequent surgeon's~     decision.~      The investigators also will record any side effects of morphine, any associated surgical~     complications, and to identify the ultimate diagnosis.~   "
207901|NCT00839774|"~     The purpose of this study is to determine if whole and fractionated yellow pea flour,~     administered at USDA recommended dosages (50 g/day), improve risk factors associated with~     cardiovascular disease and diabetes.~   "
207902|NCT00839761|"~     Background: How best to improve iron status among infants in low-income settings is of~     continued concern in many countries, including Brazil~      Objective:~      Design: In a double blind, 5-mo, home-based trial in Brazil, mildly anemic 6 - 24 month-old~     children (n=175) were randomly assigned to receive either Ultra Rice (URG) fortified with~     23,4, mg Fe as micronized ferric pyrophosphate (MFP) and a placebo solution of iron drops, or~     identical non-fortified rice (CG) and a solution of iron drops. Parents were instructed on~     the correct dosage of iron drops and to feed their children (including whether and how much~     rice) as they normally would. Iron status and hemoglobin (Hb) were measured at baseline and~     at 5 mo.~   "
207903|NCT00839748|"~     The purpose of this study is to collect information in order to identify people who have~     asthma and who may be good candidates to participate in one of the future asthma studies to~     be conducted at The Ohio State University Asthma Clinical Research Center.~   "
207904|NCT00839735|"~     The study focuses on trefoil family factor (TFF) peptides in sputum in lung diseases. The~     investigators hypothesize that TFF peptides are upregulated in lung diseases characterized by~     mucus hypersecretion.~   "
207905|NCT00839722|"~     The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas~     embolization, in women between 18 and 40 years old.~   "
207906|NCT00839709|"~     Rejection and infection are primary causes of morbidity and mortality in solid organ~     transplant recipients. Current clinical practice relies on immunosuppressive drug levels~     measured in plasma to reflect the peripheral immune response in solid organ transplant~     recipients. Direct measurement of the number and functions of the immune cells themselves~     using multi-parameter flow cytometry may enable individualized immunosuppression management~     for organ transplant recipients. Multi-parameter flow cytometry will be used to compare~     levels and functional capabilities of multiple lymphocyte subsets between cohorts of patients~     receiving depletion induction and those receiving a non-depletion regimen. The activation~     state, cytotoxic potential and the functional capabilities of these cells will be examined~     within patients over the first six months post transplant.~   "
207907|NCT00839696|"~     Mammographic density is sensitive to estorgen exposure and constitutes a strong intermediate~     maker of breast cancer risk. We hypothesize that women with higher serum xenoestrogen levels~     will have greater mammographic density.~   "
207908|NCT00839683|"~     Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin~     and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and~     dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of~     valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK~     of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects~   "
207909|NCT00839670|"~     The purpose of this trial is to compare the effect of a modified constraint induced therapy~     to the treatment described originally by Taub et al.. This study will determine if LICITE~     will lead to similar improvements than the original described method.~   "
207910|NCT00839657|"~     Individuals taking warfarin often need frequent dose changes as the international normalized~     ratio (INR) gets too high or too low which could result in a higher risk of thromboembolism,~     bleeding and early discontinuation of a highly useful therapy. This study will compare two~     approaches to warfarin dosing to examine the utility of using genetic information for~     warfarin dosing.~   "
207911|NCT00839644|"~     The purpose of this study is to compare the effect of three airway secretion clearance~     techniques (chest physical therapy, flutter device and high frequency chest wall oscillation)~     on decline in pulmonary function over a three year period in patients with cystic fibrosis.~   "
207917|NCT00839553|"~     The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first~     episode, and the optimal treatment remains unknown. In the recently published British~     Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment~     for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of~     this procedure was as high as 25-30%, making it inappropriate as a standard of care.~      Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way~     to shorten the duration of air leaks and reduce the rates of recurrent spontaneous~     pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline,~     talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous~     pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer~     available. Talc insufflation of the pleural cavity is safe and effective for primary~     spontaneous pneumothorax. However, it should be applied either with surgical or medical~     thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in~     inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional~     minocycline pleurodesis is a safe and convenient procedure to decrease the rates of~     ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In~     the present study, additional minocycline pleurodesis will be randomly administered in~     patients with first episode of primary spontaneous pneumothorax after simple aspiration. The~     primary goal is to test if intrapleural minocycline can reduce the rate of recurrence. The~     secondary goals are to evaluate the safety profile, short-term results, and long-term effects~     of minocycline pleurodesis after simple aspiration. The sites of study include National~     Taiwan University Hospital and Far Eastern Memorial Hospital. A total of 300 patients (150~     patients in each arm) will be included for this study.~   "
207918|NCT00839540|"~     The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is:~      To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin~     (MFG) against Candida isolates from the subject and against Candida glabrata with varying~     degrees of caspofungin susceptibilities.~      This investigation will provide clinicians information supporting the use of caspofungin and~     micafungin in situations where Candida strains may be a cause of infection.~   "
207919|NCT00839527|"~     The purpose of this study is to determine the safety and efficacy of albiglutide in subjects~     with type 2 diabetes~   "
207920|NCT00839514|"~     This study is to follow-up with workers from a local company that had exposure to TCE that~     may have symptoms of Parkinson's disease. We hope to learn more about TCE exposure and~     Parkinson's disease. Eligible participants will be those who participated in previous~     research study entitled Survey of Selected Exposures and Neurologic Symptoms in an~     Industrial Population~   "
207921|NCT00839501|"~     Andersen-Tawil Syndrome (ATS) is a rare genetic disorder that causes episodes of muscle~     weakness, potentially life-threatening changes in heart rhythm, and skeletal developmental~     abnormalities. The cause of some ATS cases remains unknown, and no specific treatments have~     been established. The purpose of this study is to determine whether potassium supplements~     and/or the medication acetazolamide affect the duration of muscle weakness and heart rhythm~     abnormalities in people with ATS.~   "
207922|NCT00839488|"~     Although stress ulcer is a complication that can cause significant mortality and morbidity in~     critical patients with risk factors, there is still lack of consensus about its prophylaxis.~     There are also few data available from Taiwan. H2 blockers are commonly used due to~     convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less~     association with nosocomial pneumonia. Recently, proton pump inhibitors were shown to have~     good prophylactic effects for stress ulcer. Pantoprazole (iv) is the first intravenous form~     of proton pump inhibitor that was approved by FDA. There are some reports about its~     application for treatment of peptic ulcer bleeding. It also has good acid suppression effect~     in patients under critical care. We expect that intravenous pantoprazole will have a role in~     stress ulcer prophylaxis.~      We will enroll those patients that have received major abdominal surgery and admitted to~     surgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days~     within 24 hours. They are randomly allocated to 2 groups. Group I: pantoprazole 40 mg iv~     bolus stat and then qd ; Group II: famotidine 20 mg iv bolus stat and then q12h. We will~     monitor the following data: operation type & time, APACHE II score, CBC, CXR, stool character~     and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopic examination~     will be performed. We define the end point as overt bleeding, death or transfer out of ICU.~     We will compare the prevalence of UGI bleeding and ventilator associated pneumonia in these 2~     groups~   "
207923|NCT00839475|"~     The purpose of this study is to demonstrate the CervicalMD device's ability to collect~     digital imagery suitable for a colposcopy examination.~   "
207924|NCT00839462|"~     The study focuses to prove the equivalent efficacy of two different Dexpanthenol~     formulations.~   "
207925|NCT00839449|"~     Cerebral vasospasm following subarachnoid hemorrhage (SAH) is the most common cause of~     morbidity and mortality. Recent studies indicate that Rho-kinase play an important role in~     the occurrence of such cerebral vasospasm. Eicosapentaenoic acid (EPA) inhibits~     sphingosylphosphorylcholine (SPC)-induced Rho-kinase activation in vitro. So this study~     examines whether EPA prevents cerebral vasospasm occurrence after SAH in patients.~   "
207926|NCT00839436|"~     Background:~        -  Idiopathic CD4 lymphocytopenia (ICL) is a condition in which patients have low levels of~          T cells, a type of white blood cell that helps fight infection. Animal studies have~          shown that an experimental drug Interleukin 7 (IL-7), which is named CYT107, can~          increase the number and function of T cells. CYT107, however, has not been used in~          people with ICL.~      Objectives:~        -  To determine the safety of CYT107 in people with ICL.~        -  To determine whether CYT107 will increase the number and function of T cells in people~          with ICL.~      Eligibility:~        -  Patients 18 years of age and older diagnosed with ICL and who are at risk of becoming~          sick because of this condition are eligible for this study. In addition, patients must~          not be pregnant, or have other illnesses that would cause low CD4 T cell counts, such as~          human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection.~      Design:~        -  The initial screening visit will include the following examinations and tests:~        -  A complete physical exam and medical history~        -  Blood analysis, including CD4 T cell count; complete blood count and additional blood~          tests to determine clotting ability and blood composition; thyroid, liver, kidney, and~          pancreatic function tests; HIV and HTLV tests; and tests for anti-IL-7 antibodies that~          block normal IL-7 activity~        -  Routine urine test~        -  Urine or blood pregnancy test for women~        -  Chest X-ray~        -  Electrocardiogram~        -  Spleen ultrasound.~        -  The baseline visit will include blood tests to determine levels of each of the major~          types of antibodies, a test of genetic background, and more detailed CD4 and protein~          analysis. In addition, leukapheresis (a procedure to collect large numbers of immune~          cells without red blood cells) will be done. Participants will also have the option of~          having colon and lymph node biopsies.~        -  The schedule will be as follows:~        -  Weeks 1, 2, and 3 (Cycle 1): Three weekly IL-7 dosing visits.~        -  Weeks 5, 8, and 12: Follow-up visits.~        -  Weeks 24, 25, and 26 (Cycle 2): Three more weekly IL-7 dosing visits.~        -  Weeks 28, 31, and 35: Follow-up visits.~        -  Week 48: End of study visit.~        -  Tests conducted before getting IL-7 will be repeated during the IL-7 cycles and~          follow-up visits to compare with earlier values. Optional colon and lymph node biopsies~          done at baseline will be repeated 1 6 weeks prior to Cycle 2 and 1 6 weeks prior to Week~          48.~   "
207927|NCT00839423|"~     The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and~     tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive~     Disorder (MDD).~   "
207928|NCT00839410|"~     This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the~     largest consortium of University hospitals over Europe. 7 investigation sites (7~     dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be~     enrolled and be followed during 10 years.~   "
207932|NCT00839358|"~     The aim of this study is to evaluate the effect of prolonged administration of albumin and~     midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic~     encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver~     transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver~     transplantation will include in the study. Patients will be randomized to receive albumin and~     midodrine (treatment group) or administration of placebo (saline for albumine) and tablets~     with excipients without midodrine (control group). Patients will be followed-up during 12th~     months. In the treatment group albumin will be given at a dose of 40g every 15 days and~     midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment~     that patients require by cirrhosis. The group control will receive placebo in the same way~     than the treatment group in addition with lactitol and the specific treatment that they~     require by their disease. In all the patients liver and renal function test, hormones~     determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal~     conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months.~     Before the inclusion in the study neuropsychological test and critical flicker test will be~     performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months.~     All the determinations will be repeated at any time that the patients develop any~     complication considered as an end point. In baseline conditions and at 3rd and 6th months a~     questionnaire of quality of life (SF36) will be performed. During a year of follow-up the~     number of paracentesis that patients require, the incidence of renal failure and EH and their~     relationship with hormonal activity and cytokine levels, free transplant survival and quality~     of life will be recorded.~   "
207933|NCT00839345|"~     The purpose of the study is to determine, whether the resistance to clopidogrel could be~     affected by higher doses of this drug, or by replacement of clopidogrel with another~     ADP-antagonist ticlopidine.~   "
207934|NCT00839332|"~     The purpose of the Phase 1 portion of this study was to determine the dose of LY2603618 that~     can be safely administered 24 hours after gemcitabine treatment. This dose was then used for~     the Phase 2 portion of the study. The Phase 2 portion of the study evaluated whether~     LY2603618, when administered 24 hours after gemcitabine therapy, was an effective treatment~     for participants with pancreatic cancer.~   "
207935|NCT00839319|"~     The purpose of this investigational study is to determine how much male hormone,~     testosterone, is necessary to maintain sperm production in the testis. This knowledge will be~     used to help in the development of a safe male hormonal contraception.~   "
207936|NCT00839306|"~     The purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg~     (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in~     subjects with healed erosive gastroesophageal reflux disease (eGERD).~   "
207937|NCT00839293|"~     The purpose of this study is to evaluate the safety and compare the bioavailability of~     fenofibric acid from 2 different dosage strengths of ABT-335.~   "
207938|NCT00839280|"~     The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol~     formulations~   "
207939|NCT00839267|"~     The purpose of this study is to compare clopidogrel effectiveness between severe~     hemodynamically unstable versus stable patients with acute myocardial infarction.~   "
207940|NCT00839254|"~     The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal~     conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H.~     influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy~     tube placement and outpatient antimicrobial prescriptions in children starting vaccination~     below 18 months of age. These data will be collected from the national registers and will be~     analyzed in combination with data collected for subjects enrolled in a large scale~     cluster-randomized study 111442.~      The study will also assess the immune response to the GSK1024850A vaccine and the impact of~     the vaccine on occurrence of acute otitis media, carriage, safety in children starting~     vaccination below 18 months of age.~   "
207941|NCT00839241|"~     The primary objective of the study is to compare the immunological status after either~     autologous blood transfusion as administered by Bellovac® ABT or allogenic blood transfusion,~     with regards to change in Natural Killer (NK) cell frequency in patients undergoing total~     knee replacement.~   "
207942|NCT00839228|"~     Up to half of all patients with clinical features of heart failure are found to have normal~     heart pumping function. Recently the investigators have shown that a drug called perhexiline~     markedly improved exercise capacity and symptoms in patients with heart failure associated~     with impaired cardiac pump function. In this proposal the investigators will assess whether~     perhexiline has beneficial effects in patients with heart failure and a normal heart pumping~     function.~   "
207943|NCT00839202|"~     A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure~     measures a rate assay which is subject to much artefact. The hypothesis is that the new assay~     will give a reading of absolute quantities of FVIII which will provide a more suitable~     indicator of FVIII content for clotting factor manufacturers, physicians and patients.~   "
207944|NCT00839189|"~     The purposes of this pilot safety study are to identify a dose of inhaled Clinical Center~     Reference Endotoxin (CCRE) that is well tolerated by allergic subjects that induces~     measurable increases in neutrophil content of induced sputum that can be employed to screen~     large populations for susceptibility to the inflammatory effect of inhaled endotoxin.~   "
207945|NCT00839176|"~     The primary objective of this Phase IIa trial is to determine the effective dose and~     treatment period for an upcoming RX-10100 Phase IIb trial in subjects with major depression~     disorder (MDD). The secondary objectives of this trial are to evaluate the safety and quality~     of life in subjects with MDD receiving RX-10100 treatment.~   "
207946|NCT00839163|"~     The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety~     and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to~     find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future~     clinical use.~   "
207947|NCT00839150|"~     The primary purpose was to assess, in diabetic patients without diabetic retinopathy and~     control subjects, color vision, contrast sensitivity, electroretinography, and~     flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the~     earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy~     pathogenesis.~   "
207948|NCT00839137|"~     The purpose of the study is to determine if a program of regular exercise can help reduce~     asthma symptoms and also reduce the inflammation caused by asthma. If successful, this would~     allow regular exercise to be recommended as a therapy for people with asthma, which could~     possibly reduce the amount of medicine that people with asthma need to control their asthma~     symptoms.~   "
207989|NCT00838578|"~     The primary objective of the Phase II portion of this study is to assess the efficacy of~     KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil,~     leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in~     patients with metastatic colorectal cancer.~   "
207949|NCT00839124|"~     This will be a single center, open label study comparing baseline characteristics of~     recovered sputum cells (collected on screening day) to those of cells recovered 6 hours after~     inhalational challenge with 20,000 EU Clinical Center Reference Endotoxin (CCRE, a component~     of air pollution)) within each group as well as cross group comparisons between individuals~     with allergic asthma (AA's)and normal volunteers (NV's). The primary objective of this study~     is to test the hypothesis that persons with allergic asthma will have an increased neutrophil~     response to challenge with 20,000 EU CCRE compared to normal volunteers. Secondary objectives~     include post CCRE comparison between AA's and NV's with regard to changes in airway cells and~     blood as well as changes in mucociliary clearance (MCC) in response to inhalation of 20,000~     EU CCRE.~   "
207950|NCT00839111|"~     The purpose of this study is to evaluate the Progression-Free Survival (PFS) time of~     Sorafenib in combination with FOLFIRI regimen used as in the second front treatment in~     patients with advanced CRC after failure of oxaliplatin treatment.~   "
207951|NCT00839098|"~     The purpose of this randomized control study is to evaluate the use of electric powered~     wheelchairs and powered seating function patterns of Veterans to determine how usage patterns~     relate to activity, participation, and seating discomfort. In addition, it will be determined~     if a training program or a training program with a virtual coach will improve compliance of~     clinical practice guidelines for pressure relief, upper limb preservation, and discomfort~     management. The virtual coach is a portable, programmable intelligent reminder designed to~     enhance a person's use of their power wheelchair and power seat functions.~   "
207952|NCT00839085|"~     Study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress~     induced by on pump coronary artery by pass grafting surgery.~   "
207953|NCT00839072|"~     The objective of the study is to compare the pharmacokinetic profiles of extended-release and~     immediate-release trazodone formulations~   "
207954|NCT00839059|"~     This is a Phase I, open-label, multi-center, dose-escalation study of lenalidomide in adult~     patients with newly diagnosed, relapsed or refractory acute myeloid leukemia. All patients~     will receive lenalidomide per oral daily (starting dose is 25 mg/d). Cohorts of 3 patients~     (to be expanded up to 6 if 1 dose-limiting toxicity (DLT) is observed among the first 3~     patients) will be sequentially allotted to progressively higher dose levels of lenalidomide~     on the basis of the presence and severity of lenalidomide-related toxicity or lenalidomide~     related serious adverse reactions encountered in the first cycle. For the purpose of this~     study, patients' enrollment will continue until the maximum tolerated dose (MTD) will be~     determined and characterized.~   "
207955|NCT00839046|"~     The burden of childhood asthma is borne disproportionately by children living in poverty and~     in urban centers, many of whom are from communities of color and are at greater risk for~     environmental exposures. Given the complex interaction of physical and social environmental~     factors on childhood asthma, there have been increasing calls for comprehensive efforts using~     a community-based participatory research (CBPR) approach. Community Action Against Asthma is~     a long standing CBPR partnership in Detroit, Michigan, composed of representatives from~     community-based organizations, health and human service agencies, and academia. All members~     of the partnership have been actively involved in the development of the CBPR project~     proposed here. The specific aims are: 1) to test the efficacy of air filters (AFs) separately~     and when combined with air conditioners (ACs) to reduce exposure to particulate matter (PM),~     over and above a standard community health worker home visit (standard) intervention; 2) to~     test the association between any reduction in PM exposure through the use of AFs separately~     and when combined with ACs over and above a standard intervention and health outcomes in~     children with asthma; 3) to elucidate the causal pathways by which any intervention-related~     improvements in children's asthma-related health status is occurring. One hundred and fifty~     households in Detroit, Michigan with at least one child with mild persistent or moderate to~     severe persistent asthma will be enrolled to participate in the study. Households will be~     randomly assigned to one of three groups: a standard household intervention (or control)~     group; an AF only intervention group; or an AF+AC intervention group. Extensive health and~     exposure measures will be undertaken during the course of the 12 -month intervention. Given~     the role of PM in children's asthma-related health and the higher concentrations of PM in~     microenvironments, there is a need to test the efficacy and efficiency of novel approaches to~     reducing indoor air pollutants. Doing so using a CBPR approach will enhance the relevance and~     ultimately the success of this proposed research.~   "
207956|NCT00839033|"~     The hypothesis is that a mechanical insufflation-exsufflation (MI-E) is associated with a~     decrease in the number of intubations and more rapid clinical improvement in children and~     adults with neuromuscular disease who are admitted for an acute respiratory exacerbation.In~     this prospective, randomised, multicenter study, 55 patients will be treated with standard~     treatment and a MI-E, and 55 patients with standard treatment and standard respiratory~     physiotherapy. The primary objective is the reduction of the number of patients requiring~     invasive ventilatory support (endotracheal intubation or tracheotomy) in the group treated~     with MI-E (MI-E group). The main secondary objectives are a reduction in hospital stay and an~     improvement in clinical condition, dyspnea and respiratory muscle function.~   "
207957|NCT00839020|"~     50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the~     study is a comparison between a minimally invasive and a conventional approach. In both~     groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as~     concomitant pain medication are monitored during the first 20 postoperative days and will be~     compared for the two groups. Various scores are surveyed.~   "
207958|NCT00839007|"~     The primary objective of the study is to assess the safety and tolerability of IV~     administration of CD-NP and the dose relationship of CD-NP on improvement of clinical~     symptoms and renal function in ADHF patients.~   "
207959|NCT00838994|"~     The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment~     on residual insomnia in major depressive patients.~   "
207960|NCT00838981|"~     The purpose of this study is to compare the efficacy of the combined treatment modafinil +~     Contingency Management (CM) to either treatment condition alone or to yoked-controls on~     cocaine abstinence.~      To investigate the role of modafinil-related improvements in memory, impulse control, and~     attention in mediating cocaine abstinence.~   "
207961|NCT00838968|"~     The purpose of the study is to determine whether interferon-alpha is effective in the~     treatment of p48 Positive patients with HCC after curative resection.~   "
207962|NCT00838955|"~     This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard~     treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus~     has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in~     patients with Hodgkin Lymphoma who have been previously treated with chemotherapy.~   "
208140|NCT00836602|"~     The primary purpose of this study is to evaluate the safety and tolerability of multiple oral~     doses of BMS-779788 in healthy subjects~   "
207963|NCT00838942|"~     The VIVA study is focused on Alzheimer's disease patients with a low vision due to a~     bilateral cataract. The aim is to study cataract surgery results on patients' autonomy,~     behaviour, and mood. In fact those dement elderly patients suffer from a progressive loss of~     superior functions, with loss of autonomy, behaviour and mood degradation, associated with~     physical disabilities. The work hypothesis is that a loss of sensorial functions,~     particularly visual, is an aggravating factor of NEURO-cognitive troubles and absence of~     communication with outside circle. The protocol consists in investigating superior functions,~     autonomy, and behaviour troubles of the participating patients, with the help of a series of~     neuropsychological tests used one month before and three months after cataract operation on~     the eye with the worst vision. Independently of the study, patients must have given an~     informed consent to cataract surgery. Their participation lasts 4 months+/- 1 month. The aim~     of the study is to evaluate whether the cataract surgery improves patients' behaviour,~     autonomy and mood and possibly to show evidence onf drawbacks in of such a practice.The main~     objective targets to cataract surgery benefice on patients suffering from both Alzheimer's~     disease and impeding cataract, aiming to improve behaviour troubles. The specific objective~     is to measure this benefice in correlation with visual acuity improvement.~   "
207964|NCT00838929|"~     Vorinostat in combination with radiation therapy can be administered safely and will be~     tolerated in patients with brain metastases, while providing an assessment of the anti-tumor~     activity of this combination.~      This is a multi-center, open-label, non-randomized Phase I study in patients with brain~     metastases. Patients will be administered oral Vorinostat and radiation therapy and will be~     treated for 3 weeks. Patients will be enrolled in cohorts and will be treated at sequentially~     rising dose levels of Vorinostat combined with radiation therapy. We will initially enter 3~     subjects at each dose. If none of the three experiences a dose-limiting toxicity we will~     proceed to the next dose. If one of the three experiences that level of toxicity, we will~     accrue 3 more subjects at that dose. If at any time there are two or more dose-limiting~     toxicities (in the 3-6 subjects) on a given dose, we will drop down to a lower dose. Dose~     escalation will continue until the MTD of Vorinostat and radiation therapy is established.~     The MTD will then be one dose below the DLT occurring in at least 1 out of 3 subjects (2 out~     of 6 patients).~   "
207965|NCT00838916|"~     A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.~   "
207966|NCT00838903|"~     The purpose of this study is to determine if albiglutide is safe and effective in the~     treatment of type 2 diabetes.~   "
207967|NCT00838890|"~     To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects~     with Refractory Hematologic Cancer~   "
207968|NCT00838877|"~     The study is carried out in order to investigate if [18F]AZD4694, compared to [11C]AZD2184,~     is a suitable PET ligand for in vivo imaging of Aβ amyloid depositions in the human brain. In~     the study the two PET ligands will be examined in both healthy volunteers and patients with~     Alzheimer's Disease. A whole body dosimetry scanning will be performed in 6 healthy~     volunteers to obtain human data to estimate a safe dose.~   "
207969|NCT00838864|"~     Prophylactic antibiotics have been routinely recommended for cirrhotic patients with upper~     gastrointestinal bleeding recently. However, the regimen and duration of its use remain an~     inconclusive issue. Quinolones and 3rd generation cephalosporins have been more often used~     for prophyalxis recently. The duration for antibiotic usage were variable in the literatures,~     ranged from 4-10 days. The latest guideline from AASLD in 2007 was 7 days. In the survey of~     infections in cirrhotic patients with UGI bleeding performed by Bernard et al, most~     infections occurred in the first 5 days and half within the first 48 hours. Therefore,~     considering the cost-effectiveness and drug resistance issues, the necessity for such~     prophylaxis for 7 days may need to be re-evaluated.~      The purpose of our study is to investigate the antibiotic prophylaxis duration for cirrhotic~     patients with acute gastro-esophageal variceal bleeding. We will enroll those patients~     suffering from variceal bleeding documented by endoscopic examination and without apparent~     evidence of infection. Those who have received antibiotics within 2 weeks, are less than 18~     years old, get pregnant, have malignancy other than HCC, have allergy to ceftrioxone are~     excluded. After receiving well explanation and giving consent, these patients are randomly~     allocated to 2 groups and receive prophylactic antibiotic just after endoscopic examination;~     Group I: receiving ceftriaxone 500 mg iv bolus stat and then q12h for 3 days, Group II:~     receiving ceftriaxone 500 mg iv bolus stat and then q12h for 7 days. They will receive~     appropriate endoscopic treatment for gastro-esophgeal varices and glypressin 1mg q6h for 3~     days. They will start to feed on the 2nd day if not contraindicated. The 2nd endoscopic~     treatment for varices will be performed 2 weeks later. We record the demographic data, vital~     signs, transfusion amount; check hemogram, U/A, CXR, ascites routine (with apparent ascites),~     classification of variceal size and Child-Pugh classification. We monitor the events of~     rebleeding & infection, transfusion amount and hospitalization days We use rebleeding rate~     within 14 days as the primary end point. It is defined as the following events after initial~     stabilization of vital signs for 24 hours; (1): recurrence of hematemesis or bloody stool~     (2); need of transfusion more than 2 unit of blood and systolic pressure < 100 mmHg or pulse~     rate > 100/mn. We use infection rate during admission and mortality rate within 28 days as~     secondary end points.~   "
207970|NCT00838851|"~     The purpose of this study is to determine the range of neutrophil response (influx of PMNs to~     the airways as determined in sputum) after inhalation of CCRE (20,000 EU).~   "
207971|NCT00838838|"~     Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to~     decreased bone mineral density resp osteoporosis. In this study bone mineral density is~     assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for~     osteoporosis and and on a standard physiotherapy exercise program one group receiving Nebido~     for testosterone replacement (TRT). The additional effect of TRT on bone mineral density /~     osteoporosis is assessed (CT scan lumbar spine).~   "
207972|NCT00838825|"~     The purpose of this study is to compare health care delivery outcomes and costs achieved by~     two different approaches to health care delivery. The investigators will compare health~     outcomes for groups of adult patents with diabetes. One group will be managed by our~     traditional approach to diabetes care. The second group's care delivery is structured~     according to a design consistent with the Chronic Care Model (CCM).~   "
207973|NCT00838812|"~     The purpose of this study is to determine the safety and efficacy of association between~     tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.~   "
207974|NCT00838799|"~     This study is designed to evaluate the safety and efficacy of RGH-896 in patients with~     diabetic peripheral neuropathic pain.~   "
207975|NCT00838773|"~     This grant involves 24 social networks of young men who have sex with men, Roma, and young~     high-risk heterosexual adult men and women living in Hungary, Bulgaria and Russia.~   "
207990|NCT00838565|"~     This study will evaluate the safety and tolerability of PF-04236921 administered monthly as~     three intravenous infusions. Each group of patients will be assigned to a dose level; Safety~     and tolerability of a low dose level will be required before proceeding to successively~     higher dose levels. Blood tests will be performed to measure the amount of drug and changes~     in measures of inflammation.~   "
207976|NCT00838760|"~     The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics~     (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single~     oral doses of TMC558445 and of multiple increasing oral doses followed by a single dose of~     TMC310911 to assess the potential boosting effect on the latter compound. In this study, two~     investigational new drugs are involved, TMC558445 and TMC310911.~      The study has been amended as follows:~      TMC558445 will be administered either twice a day (b.i.d.) or once daily (q.d.). A single 300~     mg or 600 mg dose of TMC310911 will be administered under fasted or fed conditions. The~     boosting effect on Darunavir will be investigated.~   "
207977|NCT00838747|"~     The folate receptor (FR) is a cell marker that is over expressed on the cell surface of~     certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also~     express the FR, however in these normal tissues the FR is usually located on the tissue~     surface that is inaccessible to circulating drugs. As such, drugs which target the FR may~     potentially be used to achieve anti-tumour efficacy whilst reducing toxicity to normal~     tissues. Therefore the ability to measure FR levels from different cancer types may help to~     select patients who are most likely to benefit from treatment with FR targeted therapies. One~     such drug BGC 945 is currently being tested in preclinical study at The Institute of Cancer~     Research~   "
207978|NCT00838734|"~     In this study, the investigators employed Visante-OCT (Carl Zeiss, USA), an anterior chamber~     optical coherence tomography, to monitor the change of anterior chamber dimensions. These~     data were correlated to anterior and posterior curvature changes collected with the Oculus~     Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug~     principle. To minimize the effect of convergence and excyclotorsion during examination,~     topical cycloplegic medication was used. The investigators hypothesized that if there is a~     link between ciliary muscle contraction and cornea curvature, installation of cycloplegic~     should result in widening of anterior chamber angle to angle distance and flattening of the~     cornea curvature data.~   "
207979|NCT00838721|"~     Laser Trabeculoplasty has been shown to be effective in lowering intraocular pressure (IOP)~     in patients with primary open-angle glaucoma (POAG). Although initially demonstrated with the~     Argon laser (ALT), several other laser systems have also been employed with comparable~     efficacy. Recently, Selective Laser Trabeculoplasty (SLT) has been shown to lower intraocular~     pressure comparable to ALT. The advantage of SLT is that the target eye structure, the~     trabecular meshwork, remains intact with minimal damage at the cellular level. In contrast,~     ALT lowers IOP at the expense of scarring of the trabecular meshwork. The purpose of this~     study is to evaluate the efficacy of lowering IOP with Pascal Laser Trabeculoplasty (PLT)~     employing reduced energy levels compared to ALT and a computer guided pattern of laser~     treatment applications.~   "
207980|NCT00838708|"~     Pruritus is an essential feature for the diagnosis of atopic dermatitis and may play an~     important part in disease progression. Itching has a significant impact on the quality of~     life of AD sufferers, in particular night-time itching leading to sleep disturbance and~     subsequent poor daytime performance.~      The objective of this study is to determine whether SRD174 Cream is a safe and effective~     therapy for moderate to severe pruritus associated with atopic dermatitis.~   "
207981|NCT00838695|"~     The goal of this project is to determine the genetic factors contributing to interindividual~     differences in response to physiological and pharmacological vasoconstrictors and~     vasodilators.~   "
207982|NCT00838682|"~     This study is conducted to compare and evaluate the effect of administering a high-dose~     intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent~     bleeding after the endoscopic treatment of bleeding peptic ulcers.~   "
207983|NCT00838669|"~     The purposes of this study are to evaluate the effect of food on the pharmacokinetics of~     extended-release (ER) OROS paliperidone in healthy men, and to evaluate the effect of posture~     on the pharmacokinetics of ER OROS paliperidone under fasting conditions. Additionally, the~     safety and tolerability of the treatments in healthy men will be assessed.~   "
207984|NCT00838656|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, gemcitabine, and paclitaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after~     surgery may kill any tumor cells that remain after surgery. It is not yet known which~     treatment regimen may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving one of two chemotherapy~     regimens containing carboplatin, gemcitabine, and paclitaxel works in treating patients~     undergoing surgery for newly diagnosed primary stage IIIC or stage IV ovarian cancer,~     fallopian tube cancer, or primary peritoneal cancer.~   "
207985|NCT00838643|"~     Evaluation of incidence of invasive aspergillosis in patients who have undergone an~     allogeneic stem cell transplantation, with particular regard to the role of galactomannan~     assay and of early TC scan in asymptomatic patients.~   "
207986|NCT00838630|"~     The objective of this randomized, single-dose, two-way evaluation is to compare the~     bioequivalence of a test cilostazol formulation to an equivalent oral dose of the~     commercially available cilostazol in a test population of 36 adult subjects under fasting~     conditions.~   "
207987|NCT00838617|"~     This is a study in patients with Amyotrophic Lateral Sclerosis (ALS). We will use muscle~     ultrasound as a tool to try and see if there are changes in muscle size that can find out how~     fast ALS is progressing. This might give us a better way to carry out further studies on new~     drugs to see if they might help slow the progression of ALS.~      Participants in the study will have muscle ultrasound performed on a few muscles in the arms~     and legs at the first visit, and again 3 months later, and one last time 3 months after that.~     This takes about 10 minutes, is painless, and involves scanning the muscle with a handheld~     device, with some gel applied to the skin. At each visit, there will also be a questionnaire~     about symptoms and strength testing.~   "
207988|NCT00838591|"~     The objective of this clinical study is to examine the safety and effectiveness of~     intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in~     subjects experiencing an acute exacerbation of asthma.~   "
207991|NCT00838552|"~     The study compares the biochemical markers in bronchoalveolar lavage samples from asthmatic~     children to those markers found in non-asthmatic children with other respiratory diseases.~     The investigators hypothesize that certain markers will be associated specifically with~     asthma.~   "
207992|NCT00838539|"~     The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of~     neratinib in combination with temsirolimus in subjects with solid tumors. This study will~     also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK)~     parameters of the combination.~   "
207993|NCT00838526|"~     The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50~     mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing~     in subjects with healed erosive gastroesophageal reflux disease (eGERD).~   "
207994|NCT00838513|"~     The purpose of this study is to determine whether eculizumab is safe and effective in the~     treatment of adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome~     (aHUS).~   "
207995|NCT00838500|"~     The main objective of this study is to test the hypothesis that a 3 week intensive course of~     spa therapy can reduce the risk of leg ulcers in patients with advanced chronic venous~     insufficiency (C4a-b and C5 of the CEAP classification) at one year.~   "
207996|NCT00838487|"~     Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the~     improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western~     Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral~     administration(sulfate glucosamine + chondroitin sulfate sodium) in association with~     therapeutic exercises, compared to placebo in association with therapeutic exercises in~     individuals with knee OA and not exposed to prior treatment with the products under~     investigation.~   "
207997|NCT00838474|"~     Music has been consistently shown to reduce stress and increase weight gain in premature~     infants. The mechanism of this presumed improved metabolic efficiency is unknown. We aim to~     test the hypothesis that music by Mozart reduces energy expenditure in growing healthy~     preterm infants.~   "
207998|NCT00838461|"~     This is intended to provide an initial safety assessment of HSD-016 and also to evaluate how~     the drug is absorbed and eliminated and its effect on the body in healthy subjects.~   "
207999|NCT00838448|"~     In this study the investigators will explore the relationship between physical activity and~     cannabis use. The investigators will compare regional brain activation detected by imaging~     technique(fRMI) before and after exercise in cannabis users and compare results with results~     from controls. The investigators hypothesize that the regional brain activation in response~     to visual cues (pictures related to cannabis use and food) will be different in cannabis~     users than in controls and that exercise will significantly alter brain responses to the~     cues.~   "
208000|NCT00838435|"~     This multicenter, open label study is designed to evaluate the safety of Kuvan® and its~     effect on neurocognitive function, blood Phe concentration, and growth in children with PKU~     who are 0-6 years old.~   "
208001|NCT00838422|"~     The purpose of this study is to assess the repeatability, reproducibility, and agreement of~     central corneal thickness measured by Fourier Domain Optical Coherence tomography (FD-OCT,~     OptoVue, USA) with anterior corneal module, 20MHz ultrasound pachymetry equipped with Ocular~     response analyzer (ORA, Reichert Ophthalmic Instruments, USA) and 10MHz Ultrasound Pachymetry~     (USP).~   "
208002|NCT00838409|"~     This study will be a cross-sectional study. The primary aim of this study is to compare the~     relationship between neurological function, metabolic measures and health-related behaviors~     between normal weight and overweight/obese perimenopausal women.~   "
208003|NCT00838396|"~     The purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil~     (XP19986) compared to placebo in patients with gastroesophageal reflux disease.~   "
208004|NCT00838383|"~     This is a multi-center, randomized study of sitaxsentan administered intravenously to~     subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and~     cardiac valve replacement procedures that require CPB.~   "
208005|NCT00838370|"~     The primary purpose of this study is to prospectively determine whether capecitabine and~     5-FU-induced toxicity is preventable by dose reduction prior to start of the first~     administration in patients heterozygous or homozygous mutant for DPYD*2A, and to determine~     whether this strategy is cost-effective. Secondly, an individualized treatment algorithm for~     capecitabine and 5-FU therapy in DPYD*2A mutant patients will be developed and the~     pharmacokinetic profile of capecitabine and 5-FU will be assessed.~   "
208006|NCT00838357|"~     This is a research study intended to further investigate the safety and efficacy of~     plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell~     mobilisation attempts or who have previously received more than one autologous or any~     allogeneic stem cell transplant are not eligible.~   "
208007|NCT00838344|"~     In this study, the investigators will evaluate the impact of a Medication Adherence Program~     (MAP), a systematic telephone call to patients who are overdue for refills, to assess~     individual reasons or barriers to refilling prescribed DM medicines, discuss diabetes care~     progress, and provide intervention to resolve any barriers to taking prescribed medicines.~     The hypothesis for the study is that personalized telephone follow-up by a pharmacist will~     assist people who have missed refilling their prescriptions in taking diabetes medicines by~     resolving medication adherence challenges. Following randomization, the intervention will be~     offered to patients of four Seattle-area Safeway Pharmacies, Inc, who are overdue for~     prescribed DM medicine refills by at least 6 days. Control subjects will receive usual~     pharmacy care at the participating Safeway pharmacies as a comparison. The study will provide~     medication adherence support to intervention subjects for 12 months following enrollment with~     the goal of improving medication refilling and persistence.~   "
208019|NCT00838188|"~     OBJECTIVE. Neonatologists consider early feeding at the breast to be too tiring for preterm~     infants, although there is no evidence that this is actually the case. It is also not known~     whether the method of feeding affects energy expenditure. We hypothesized that resting energy~     expenditure (REE) would be higher after breastfeeding than after bottle feeding.~      PATIENTS AND METHODS. preterm ( >32 weeks GA) stable infants who are nourished entirely by~     their mothers' breast milk will be studied when fed expressed breast milk either by bottle or~     at the breast. REE will be measured for 20 minutes after feeding. Breast milk quantity is~     evaluated by pre- and post feeding weighing.~   "
208036|NCT00837967|"~     The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler®~     160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on~     top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma~     patients.~   "
208008|NCT00838331|"~     Transfusion of red blood cells is often used in critically ill patients with low red blood~     cell counts to prevent disease progression and death. Recent studies suggest that the use of~     aged versus fresh red blood cells are associated with worse clinical outcomes. There is~     evidence that red blood cells work with the cells lining our blood vessels to produce a~     variety of substances that normally cause arteries to relax and increase blood supply. Two of~     these substances are called nitric oxide (NO) and endothelium-derived hyperpolarizing factor~     (EDHF). The investigators are trying to determine the nature of these substances in human~     beings when they are transfused aged versus fresh red blood cells. It is their thought~     that aged red blood cells have less of the substances (NO and EDHF) that naturally relax~     our arteries and further changes the blood supply. One way to determine this is to transfuse~     a subject's own aged and fresh red blood cells and inject substances such as L-NMMA (L-NG~     monomethyl arginine) and TEA (tetraethylammonium chloride), which block the production of NO~     and EDHF respectively, and then, study what happens to the blood flow.~      There is evidence that red blood cells produce NO, which normally causes arteries to relax~     and increase blood supply. The investigators will try to determine the nature of NO in red~     blood cells and whether the amount of this substance is altered because of different blood~     processing and storage techniques. It is their thought that aged red blood cells have less~     NO that naturally relaxes our arteries and further changes the blood supply. This study is~     designed to determine the most ideal way of storing and processing blood.~   "
208009|NCT00838318|"~     Primary Objectives:~        1. To evaluate knowledge, beliefs, attitudes and values that influence perceptions and~          utilization of colorectal cancer screening (CRCS) among first-degree relatives of~          Hispanic CRC patients.~        2. To assess factors influencing Hispanic CRC patients' communication of CRC risk and~          screening information to their FDRs.~      Secondary Objective:~      1) To establish the feasibility of recruiting Hispanic CRC patients and their FDRs from the~     institutional patient database and/or MDACC clinics.~   "
208010|NCT00838305|"~     The purpose of this study is to measure the effects of MDMA (particularly its emotional~     effects) and to determine the role of serotonin in these effects. Serotonin is a~     neurotransmitter, which is a chemical that is released by some brain cells to communicate~     with other brain cells. Many of the effects of MDMA are thought to be the result of increased~     serotonin release.~      In order to understand the effects of MDMA and role of serotonin in these effects, we will~     administer MDMA alone and in combination with the antidepressant citalopram (one trade name~     for this is Celexa). Citalopram decreases the ability of MDMA to release serotonin.~     Citalopram will therefore decrease any of MDMA's effects that are the result of serotonin~     release; we want to measure this.~   "
208011|NCT00838292|"~     The purpose of the study is to test whether food supplementation of malnourished HIV-infected~     adults (both pre-ART and ART) in resource constrained settings improves their nutritional~     status, clinical status, effectiveness of treatment, quality of life, functioning, and~     survival.~   "
208012|NCT00838279|"~     The objective of this study is to compare the rate and extent of absorption of lamotrigine 25~     mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg~     chewable dispersible tablets under fasting conditions.~   "
208013|NCT00838266|"~     The objective of this study is to evaluate the efficiency of a new mouthrinse on dental~     plaque deposits.~      The study is carried out on 50 volunteers that are asked to use the mouthrinse without any~     other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized~     design: the same subjects test the active product and the placebo.~   "
208014|NCT00838253|"~     The purpose of this study is to assess the safety and efficacy of istaroxime in patients~     hospitalized for Acute Decompensated Heart Failure (ADHF) not requiring inotropic~     therapy.This will be done by comparing the hemodynamic effect of a 24-hour infusion of three~     different doses of the drug versus placebo. Efficacy will be measured as a change in~     Pulmonary Capillary Wedge Pressure from pre-infusion to 6 hours after infusion start.~     Secondary objectives will include the evaluation of clinical efficacy and safety through~     assessment of cardiovascular and renal tolerability as well as changes in biological markers~     such as brain natriuretic peptide (BNP) and troponin I (TNI), and the neurohormones renin and~     aldosterone and also to assess the pharmacokinetics of istaroxime and its metabolites.~   "
208015|NCT00838240|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine, cytarabine, and idarubicin, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more cancer cells.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     clofarabine and to see how well it works when given together with cytarabine and idarubicin~     in treating patients with intermediate-risk or high-risk acute myeloid leukemia or high-risk~     myelodysplasia.~   "
208016|NCT00838227|"~     This is an open label 8-week trial of modafinil up to 400 mg daily added to a stable~     antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in~     patients with chronic schizophrenia. We hypothesize that modafinil, a wake-promoting agent,~     will lead to improved cognition, increased wakefulness, and decreased weight in patients with~     schizophrenia who are on stable antipsychotic regimens~   "
208017|NCT00838214|"~     This is a multicentre, multinational clinical study. It comprised two consecutive segments (A~     and B). Segment A was designed as a randomized, double-blind, double-dummy,~     active-controlled, two-arm parallel-group study. The patients received either budesonide or~     prednisone for 6 months. During segment B all patients received budesonide as an open~     treatment for additional 6 months.~      In this confirmatory study the proportion of patients with complete response was compared~     between the two treatment groups. Complete response was defined as biochemical remission~     (=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of segment~     A and lack of steroid specific side effects throughout segment A.~   "
208018|NCT00838201|"~     The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3~     years under the 20040138 Amgen study and 2 years on this study) denosumab administration as~     measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who~     previously received denosumab for non-metastatic prostate cancer.~   "
208037|NCT00837954|"~     The purpose of this trial is to demonstrate that the bleeding time of suture holes after~     construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than~     with Surgicel®~   "
208020|NCT00838175|"~     Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in~     femoral venous access site and reducing the incidence of complications associated with~     traditional closure methods. Furthermore, there are predictive factors(such as sheath size,~     obesity, procedure duration, and anticoagulation status)that we can use to assess the~     procedure's likelihood of success in various patients.~   "
208021|NCT00838162|"~     The purpose of this study is to evaluate the antiviral activity as measured by the change in~     viral load from baseline in the 14 days following initiation of treatment with 4 different~     dose regimens of TMC310911 co-administered with ritonavir.~   "
208022|NCT00838149|"~     The purpose of this study is to see whether enteral glutamine supplementation improves~     intestinal permeability and small intestinal morphology in patients with Crohn's disease.~   "
208023|NCT00838136|"~     The objective of this study is to compare the rate and extent of absorption of lamotrigine 25~     mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg~     chewable dispersible tablets under fed conditions.~   "
208024|NCT00838123|"~     The aim of this research is to explore which cognitive function would affect the job tenure~     among people with schizophrenia. The investigators plan to recruit 60 people diagnosed with~     schizophrenia and divide into two groups, employment and unemployment. The investigators will~     use several cognitive function tests to collect their cognitive functions and PANSS to~     evaluate their psychotic symptoms. And then the investigators will compare and analysis the~     data through statistic software. Finally, the investigators will have the answer about if~     cognitive functions would affect the job tenure among people with schizophrenia. And the~     investigators hope that we could get the predict factor of cognitive function to predict the~     successful employment in future.~   "
208025|NCT00838110|"~     This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in~     2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon~     20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with~     Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the~     study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label~     extension study.~   "
208026|NCT00838097|"~     This European study observes paediatric patients with Chronic Kidney Disease using~     Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use~     within this population.~   "
208027|NCT00838084|"~     This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of~     LY2811376 single doses, how the body handles the drug, and the drug's effect on the body.~   "
208028|NCT00838071|"~     The purpose of this study is to determine whether protective anti-HB serum levels are~     maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific~     hepatitis B immune globulin, in patients having previously undergone liver transplantation.~   "
208029|NCT00838058|"~     The study will try, in 2 separate parts, each using 12 research subjects, to see how a new~     form of the pill CE 224,535 gets released into the bloodstream and whether that is affected~     by food. In each part, subjects will switch among 4 treatment periods to take either~     different forms of the pill(s) or the same form either after fasting or eating a meal. The~     second part will only happen depending on whether the sponsor believes it is needed and will~     use separate subject than the first part.~   "
208030|NCT00838045|"~     This study is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos TL (thin~     lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.~   "
208031|NCT00838032|"~     Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China.~     Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for~     the patient population. Some evidence showed that quetiapine fumarate could control~     aggression and agitation within 1 week, which is appropriate for the acute treatment of~     patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of~     psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate~     timeframe for the evaluation of clinical effect of agitation and aggression symptoms~     controlling.~      In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of~     750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's~     prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine~     fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a~     small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation~     potential for weight gain and prolactin elevation, quetiapine fumarate should be well~     tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day)~     (Peuskens 2004).~      The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate~     with daily dose 600-750mg/day in improving agitation and aggression for the treatment of~     Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of~     2 weeks~   "
208032|NCT00838019|"~     The purpose of this study is to evaluate the viability of intrabone administration of~     umbilical cord blood as allogenic transplantation for the treatment of hematologic~     malignancies.~   "
208033|NCT00838006|"~     The primary objectives of this proposal are to develop objective pre-deployment predictors of~     PTSD and test two pre-deployment resiliency interventions.~   "
208034|NCT00837993|"~     Primary Objective:~        -  To reclassify the histologic grade of the serous ovarian cancer specimens of patients~          enrolled on Gynecologic Oncology Group (GOG) protocol 158 using a two-tier system.~      Secondary Objective:~        -  To determine the overall and progression-free survival of patients with serous carcinoma~          of the ovary treated on GOG protocol 158 when reclassified according to tumor grade (low~          vs. high).~      Tertiary Objective:~        -  To correlate histologic grade with other prognostic factors.~   "
208035|NCT00837980|"~     The purpose of the study is to generate a library of functional imaging and anatomical~     imaging for patients with head and neck cancers for evaluation of new radiotherapy strategies~     and planning techniques including IMRT. Secondary aims would be to observe the changes in the~     cancers as the treatment progresses as well as to define the biologically most active part of~     the tumor (biological target volume) which could be given more intensive treatment. Tumor~     volumes seen on different imaging modalities will be compared with a hope of finding an~     optimal imaging methodology for accurate visualization of the head and neck cancers~   "
208039|NCT00837928|"~     RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause~     less damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of bendamustine when~     given together with radiation therapy in treating patients with brain metastases caused by~     solid tumors.~   "
208040|NCT00837915|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg~     Extended-Release Tablets, in a fully replicated design, under fasting conditions.~   "
208041|NCT00837902|"~     The overall goal of this project is to determine the genetic factors contributing to~     interindividual differences in response to beta-blockade.~   "
208042|NCT00837889|"~     The aim of the present study is threefold: investigating 1) specific cognitive impairments in~     patients with congestive heart failure, 2) whether cognitive impairments in patients with~     decompensated heart failure improve after medical recompensation and 3) whether cognitive~     functioning is related to the long-term prognosis (mortality, rehospitalisation) of those~     patients.~   "
208043|NCT00837876|"~     RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking~     blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib~     works in treating patients with pancreatic cancer that cannot be removed by surgery.~   "
208044|NCT00837863|"~     The purpose of the study is to evaluate the safety and effectiveness of ALTU-238 in the~     treatment of children with growth hormone deficiency who have not yet reached puberty who~     lack the normal ability to make growth hormone themselves. This study will also test if~     ALTU-238 works as a weekly treatment.~   "
208045|NCT00837850|"~     A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone~     cements.~   "
208046|NCT00837837|"~     The purpose of this study is to examine the pharmacokinetic parameters of chlorpheniramine in~     children and adolescents.~   "
208047|NCT00837824|"~     This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose~     of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.~   "
208048|NCT00837811|"~     To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections~     for 48 weeks in participants with Rheumatoid Arthritis~   "
208049|NCT00837798|"~     The purpose of this registry is to produce a prospective, outcome-oriented registry to~     document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF~     Diagnostics in select SJM devices.~   "
208050|NCT00837785|"~     To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary~     metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with~     relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic~     characteristics.~   "
208051|NCT00837772|"~     Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are~     requesting consideration for a total knee replacement. Those who qualify for the knee~     replacement are informed about the study. Those who consent to participate are randomly~     assigned to either the standard cutting guide or to the new method which is a MRI generated~     cutting guide called Otismed. All patients have an MRI so both groups will be unaware of~     which surgical technique is used. All patients receive the usual pre-op care and same type of~     replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1~     and 2 years. Patients will be informed of which surgical technique they were randomized to at~     the conclusion of the study.~   "
208052|NCT00837759|"~     Background:~        -  Type 1 diabetes (T1D) occurs when the immune system attacks insulin-producing cells~          (beta cells) in the pancreas, resulting in their death.~        -  Insulin injections currently are the best method for controlling blood sugar in~          individuals with T1D. However, animal studies have shown that the drugs sitagliptin and~          lansoprazole can help reverse beta cell damage or develop new beta cells. In addition,~          Diamyd has been shown to weaken the immune process that attacks pancreatic beta cells.~      Objectives:~        -  To find out whether a combination treatment of sitagliptin, lansoprazole, and Diamyd~          will help maintain functioning beta cells and/or cause new beta cells to form.~        -  To determine how the drug combination affects insulin doses and blood sugar control.~        -  To determine whether the drug combination affects the immune response involved in T1D.~   "
208053|NCT00837746|"~     This study analysed and reported on the study data from three similar, risedronate studies,~     1996052, 2003073, and 2003096. The objective of the study was to determine the differences in~     the iliac crest bone histomorphometry and bone quality in postmenopausal women who had~     received long term therapy with risedronate.~   "
208054|NCT00837733|"~     The purpose of this study is to evaluate the influence of endometrial biopsy on increasing~     implantation rate in patients with recurrent implantation failures, 93 women with at least~     two implantation failures were evaluated. In case group endometrial biopsy was obtained from~     48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy~     rate were compared with 45 patients in control group. The results suggest that in vitro~     fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy~     outcome.~   "
208055|NCT00837720|"~     This open label, non-interventional study is to show the efficacy of antihypertensive~     treatment with Atacand in hypertensive patients. Efficacy is to be evaluated based on the~     difference in systolic and diastolic blood pressure at baseline and at both follow-up visits.~   "
208056|NCT00837707|"~     The aim of the present study was to investigate the efficacy of aripiprazole in management of~     pre-existing neuroleptic-induced tardive dyskinesia~   "
208135|NCT00836680|"~     The purpose of this study is to determine if the device is supplying sufficient diagnosis~     results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of~     an interal hernia into the Douglas pouch, as well as to determine the technical success of~     using the device at the patient.~   "
208136|NCT00836667|"~     The objective of this study is to compare the rate and extent of absorption of sertraline~     hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg~     tablet under fed conditions.~   "
208057|NCT00837694|"~     Food reinforcement, motivation to obtain food, is associated with energy intake and obesity.~     Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to~     diets and weight loss. Our previous study in non-obese adults showed that daily consumption~     of the same snack food (food typically consumed outside of meals) for 14 days significantly~     decreased its reinforcing value. The purpose of this study was to replicate and extend these~     findings to obese individuals as well as to examine effects of different portion sizes of~     snack foods on food reinforcement. Thirty-one obese (body mass index > 30 kg/m2) and 27~     non-obese (BMI < 30 kg/m2) women had food reinforcement and liking tested at baseline and~     after two weeks of daily consumption of either 0 kcal, 100 kcals, or 300 kcals daily of the~     same snack food.~   "
208058|NCT00837681|"~     The purpose of this study is to determine risk factors associated with the development of~     lung disease after hematopoietic stem cell transplantation. Depending on the results and~     findings of this study, it may be possible to predict who is at higher risk of serious~     complications and ultimately develop therapies to prevent or treat this lung disease.~   "
208059|NCT00837668|"~     to determine the genetic pathways operating at the tissue level to cause granulomatous~     inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope~     to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will~     help us understand the pathogenesis of this poorly understood disease.~   "
208060|NCT00837655|"~     The purpose of this study is to perform a randomized, controlled clinical trial to~     investigate if the phosphate binder sevelamer can improve insulin resistance and glucose~     handling in patients receiving maintenance hemodialysis.~   "
208061|NCT00837642|"~     The prevalence of infertility has been estimated at 9% worldwide. The steadily increasing use~     of assisted reproductive technologies (ART) has allowed millions of infertile couples to have~     children. These children make up for 1 to 4% of the population in developed countries. ART~     involves the manipulation of early embryos at a time when they may be particularly vulnerable~     to external disturbances. In line with this concept, studies in mice suggest that ART alters~     the activity of enzymes involved in the regulation of metabolic and cardiovascular~     homeostasis. Alternatively, infertility itself or the drugs used to stimulate ovulation may~     have adverse effects on the outcome of the offspring. The safety of ART for long-term health~     is, therefore, of utmost importance. Among the potential long-term consequences of ART,~     cardiovascular disease may represent an important candidate, but there is no information.~      Preliminary data from our group show that, children born after in vitro fertilization (IVF)~     present systemic and pulmonary vascular dysfunction at high-altitude when compared to age-~     and sex-matched control subjects.~      Therefore, the major goal of our proposal is to test the hypothesis that apparently healthy~     children born after ART display vascular dysfunction of both the pulmonary and the systemic~     circulation.~   "
208062|NCT00837629|"~     This non-interventional study is to analyse the therapeutic effectiveness in patients with~     severe COPD following a generally accepted 12-week treatment period with Symbicort~     Turbuhaler, which could anyhow be shortened or extended at physician's discretion.~   "
208063|NCT00837616|"~     Estrogen is necessary for feminization during puberty and to decrease bone resorption, the~     latter critical for the achievement of peak bone mass and normal bone health in the female.~     The practicing pediatric endocrinologist often faces the dilemma of how to best feminize~     girls with hypogonadism (lack of estrogen), manifested as delayed or arrested puberty, due to~     disorders of the brain or the ovaries. We propose a series of studies to address which type,~     dose, and route of delivery of estrogen are suitable choices in feminizing and sustaining~     estrogen concentrations in adolescent girls with Turner syndrome. To accomplish this we will~     study girls/young woman between the ages of 13 to 20 with Turner Syndrome in 2 protocols. In~     Protocol # 1 we will study 24 girls with TS, they will receive 3 different estrogen~     preparations, either by mouth or via a patch for a total of 6 weeks. They will come to the~     clinical research center for blood draws after 2 wks of taking the estrogen. With this study,~     we hope to learn how the body responds to estrogen differently, depending on the form~     estrogen is given and how high, estrogen levels gets in the blood in these girls with Turner~     Syndrome. We will be comparing these patients estrogen levels to girls that menstruate~     normally and do not have Turner Syndrome. In Protocol #2, 40 patients with TS will be~     recruited; these patients will take estrogen for 1 year, either by mouth or via a patch.~     Patients will come to the lab for blood drawn in 7 occasions and we will measure estrogen~     levels as well as other hormones and lipid levels. We will also perform a Dual-energy X-ray~     absorptiometry (DXA) study (like an X ray) to assess body composition and bone~     mineralization. We will adjust doses based on the estrogen levels we find. With this study we~     hope to learn how estrogen affects body composition, i.e., the amount of fat vs. muscle, and~     how different forms of estrogen affect blood cholesterol and other hormones. This study will~     allow us to understand better how to best replace young woman with Turner Syndrome with~     estrogen.~   "
208064|NCT00837603|"~     In transposition patients after atrial switch operation, the morphological right ventricle~     serves as the systemic ventricle. These patients often develop signs of heart failure. It is~     not known, whether physical training can safely be recommended in these patients- like heart~     failure guidelines recommend training in patients with normal anatomy. Furthermore it is not~     known, whether these TGA-patients benefit from training with respect to cardiopulmonary~     exercise capacity.~   "
208065|NCT00837590|"~     We intend to pursue the following Aims:~        1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic~          dysfunction in human pre-diabetic obesity?~        2. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in~          the context of existing treatment with metformin?~        3. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in~          the context of existing treatment with lisinopril?~      The intent of the current project is to efficiently and at low cost generate preliminary data~     along each of these lines of questioning, studying the minimum number of subjects required to~     assess the viability of the question using the current measurement approaches.~   "
208066|NCT00837577|"~     The phase III clinical trial examines the efficacy, safety, and tolerability of the addition~     of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have~     inadequate glycemic control on diet/exercise therapy and voglibose monotherapy~   "
208067|NCT00837564|"~     60 patients with chronic major depressive disorder according to DSM-IV will be included into~     the study. Patients will be randomized to receive an open treatment either with CBASP, a~     psychotherapy for chronic depression, or pharmacological treatment with Escitalopram for 28~     weeks.~   "
208137|NCT00836654|"~     The study will be performed to obtain further efficacy and safety data in order to obtain a~     marketing authorization (pivotal study). In addition, health economic data are to be~     collected.~   "
208161|NCT00836316|"~     The purpose of this study is to determine the effects of intraperitoneal administration of~     levobupivacaine on pain after laparoscopic cholecystectomy.~   "
208068|NCT00837551|"~     WBI-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug~     for the topical, cream treatment of inflammatory skin diseases. As such, it affects T-cells~     through inhibition of T-cell activities including their infiltration processes, and it shows~     direct anti-inflammatory manifestation in the mouse edema model. This was a 28 day study~     (plus one follow-up week) on patients with Atopic Dermatitis, and 36 patients were treated~     randomly, BID with either 0.5%, 1.0% or placebo. Blood samples were taken weekly for PK~     analysis.~   "
208069|NCT00837538|"~     The SpinalMouse is a computer-assisted medical device that measures and graphically reports~     on posture and range of motion of the axial spine. The data has shown to be highly valid and~     reproducible while compared to x-ray film. The aim of the study is to evaluate if the Spinal~     Mouse is a reliable clinical diagnostic device to screen those patients having instability in~     the lumbar area.~   "
208070|NCT00837525|"~     The purpose of this study is to determine if an implant material can be injected to repair~     nasal valve collapse.~   "
208071|NCT00837512|"~     The goal of this study is to determine if microneedles can effectively and painlessly deliver~     insulin to children and young adults with type 1 diabetes.~   "
208072|NCT00837499|"~     The goal of this epidemiologic research study is to find out if various risk factors and~     certain markers (substances that help identify the presence of cancer) that help predict~     increased occurrence and prognosis (outcome of disease) of breast cancer differ among~     Mexican, Mexican-American, and African-American women.~   "
208073|NCT00837486|"~     Medtronic, Inc. sponsored an investigational study of the Reclaim™ Deep Brain Stimulation~     (DBS) System in people that have treatment-resistant depression. Depression is a mood~     disorder and a serious medical condition that affects millions of Americans. Depressive~     symptoms may include loss of interest in things typically enjoyed; decreased energy levels;~     difficulty concentrating or making decisions; restlessness; and feelings of pessimism,~     hopelessness, and worthlessness. Treatment-resistant depression is a chronic and severe form~     of depression characterized by failure to respond to traditional forms of treatment, such as~     antidepressant medications and electroconvulsive therapy. Treatment-resistant depression~     significantly impacts quality of life, productivity, and is a major contributor of disability~     world-wide.~      This randomized, double-blind, sham stimulation-controlled, multi-center, prospective,~     parallel design study used deep brain stimulation technology to test whether active bilateral~     stimulation can safely and effectively improve depressive symptoms in patients with~     treatment-resistant depression compared to sham stimulation.~      Participants meeting criteria for the study were implanted with the Reclaim DBS System.~     Participants in the active group, who received active stimulation, were compared to the~     control group, who received sham stimulation, during the 16-week blinded-treatment phase. All~     participants were monitored for changes in depressive symptoms. After the blinded-treatment~     phase, all participants received active stimulation.~      Candidates for the trial were adults who had major depressive disorder and had not responded~     to several treatments for depression. Participants in the study continued to receive their~     current antidepressant medications while participating in the trial.~   "
208074|NCT00837473|"~     The purpose of this study is to determine if Plexur P grows bone in the iliac crest (where~     bone was removed or harvested) for the back surgery.~      The study will be focusing on patients who require back surgery. Often additional bone is~     required from the hip of the patient (iliac crest). When bone removed from the hip, a void~     is often created. This void will be filled in with Osteotech's Plexur P product.~   "
208075|NCT00837460|"~     The purpose of the study is to analyse the prehensions deficits and the effect of prehension~     rehabilitation in central nervous system lesioned people~   "
208076|NCT00837447|"~     The purpose of this prospective, randomized study was to compare pain, functional outcome and~     ranges of motion of the knees in patients receiving either a standard posterior~     cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.~   "
208077|NCT00837434|"~     Rheumatoid arthritis (RA) is a chronic disease that leads to inflammation and progressive~     joint damage. RA is a systemic inflammatory autoimmune disorder affecting almost 1% of the~     United States population. Current therapies target the immune system early in the disease~     process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor~     necrosis factor (TNF)-blocking agents. The primary purpose of this study is to determine the~     effectiveness of two TNF inhibitors, etanercept and adalimumab, on memory B lymphocytes~     (B-cells) in the peripheral blood of participants with RA.~      Additionally, there are 4 optional sub-studies as part of the trial:~        -  B-Cell Kinetic Sub-Study to look at changes in B-cell subsets over time and how quickly~          reductions in B-cell memory occur~        -  Vaccine Response Sub-Study to assess B cell memory in response to immunization with~          hepatitis B,-hepatitis A, and diphtheria/tetanus vaccines, and to determine whether~          T-cell vaccine responses are altered with TNF blockade~        -  Tonsil Biopsy Sub-Study to evaluate how TNF blockade affects memory B-cells in the~          tonsil dendritic cells and germinal cells~        -  Synovial Biopsy Sub-Study to evaluate how TNF blockade affects changes in memory B-cells~          in lymphoid tissue.~   "
208078|NCT00837421|"~     Specific Aim #1: To collect follow-up information about patients with sepsis in the OSUMC~     MICU who survive to hospital discharge for future retrospective IRB-approved studies.~      Specific Aim #2: To collect a registry of patients who would be interested in hearing more~     information about future prospective IRB-approved studies for survivors of sepsis.~      Specific Aim #3: To collect a blood sample from patients with sepsis admitted to the OSUMC~     MICU for future retrospective IRB-approved studies.~   "
208087|NCT00837304|"~     The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases~     largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the~     gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC).~     PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging~     modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be~     visualized and recorded by video while the colon capsule passes the colon.~      Many patients suffering from UC ask their physician for possible alternative diagnostic~     imaging because they are uncomfortable with conventional colonoscopy.~      The primary aim of the present study is to compare the new Pillcam Colon Capsule with~     standard colonoscopy with respect to assessing mucosal disease activity and localization of~     inflamed colonic mucosa in patients with known UC.~   "
208079|NCT00837408|"~     Objectives:~        -  To conduct a genome-wide association study (GWAS) to identify susceptibility genetic~          variants for diabetes among Han Chinese.~        -  To conduct resequencing of positional candidate gene/loci to identify likely functional~          variants in a subset of the cohort.~        -  To conduct replication studies of the top-100 scoring variants in three independent~          African and European ancestry samples.~        -  To investigate whether diabetes-associated variants discovered in European populations~          increase diabetes risk in Han Chinese.~      Eligibility:~        -  Patients 25 years of age with newly diagnosed T2D in Suizhou, China. Control subjects~          are nondiabetics, age and ethnically matched to patients.~      Design:~        -  The study design for both patients and controls consists of the following steps:~        -  Discuss informed consent process and obtain signed informed consent form. Informed~          consent will be administered by trained clinic staff.~        -  Assign study ID (barcode)~        -  Administer questionnaires~        -  Obtain spot urine sample~        -  Measure blood pressure~        -  Obtain anthropometric measurements including body composition~        -  Perform finger prick for blood glucose level~        -  Obtain venous blood samples~        -  Perform eye examination~        -  On the following day, perform confirmatory blood glucose for the small subset of~          participants requiring confirmation of previous test result~        -  DNA extraction of stored samples will be done at either the National Institutes of~          Health or the laboratory in China.~        -  GWAS will be conducted using publicly available software packages.~   "
208080|NCT00837395|"~     A small number of women with asthma have an increase in asthma symptoms during the~     premenstrual or menstrual period. This study is being done to investigate the possible causes~     of this premenstrual increase in asthma symptoms and to help asthma care providers identify~     those patients who may suffer from this condition.~   "
208081|NCT00837382|"~     Many service members returning from Iraq and Afghanistan have difficulties adjusting back to~     civilian life. Research shows that symptoms of posttraumatic stress disorder (PTSD) are~     particularly high in returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)~     veterans, and that combat-related nightmares and sleep disturbances are common in veterans~     with PTSD. This is of concern because people with these problems will often use unhealthy~     ways of coping. Although combat-related nightmares and difficulty sleeping are highly~     distressing, there are helpful treatments that do not involve taking medication. One of these~     treatments teaches specific skills to help people improve their sleep habits and to change~     their nightmares so that they are less upsetting. This treatment can be very helpful and~     research shows that people experience decreases in the frequency and severity of their~     nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and~     quantity after completing treatment. However, because this treatment has only been studied~     with civilians, it is not clear how well this treatment works for returning veterans. This~     study tests how well this treatment works in treating combat nightmares in veterans who also~     have PTSD from experiencing a traumatic event.~   "
208082|NCT00837369|"~     To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of~     the A2A Receptor agonist Regadenoson for detection of significant coronary artery disease~     (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and~     accuracy of perfusion and wall motion analysis to identify a coronary stenosis> 50% in~     diameter by quantitive angiography will be analyzed~   "
208083|NCT00837356|"~     This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two~     recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®,~     in haemophilia A subjects, investigating the action and safety of the drugs.~   "
208084|NCT00837343|"~     Bipolar disorder (BD) is also named as a bipolar affective disorder, belonging to a kind of~     severe mental disorder involving both mania or hypomania and depression episode, with~     lifetime prevalence between 1.2 - 1.6%. The hygienic burden of bipolar disorder is high, and~     its disease burden lies in top 10 position among the population of 15 - 44 years of old~     patients and concomitant with relative high suicide rate (10 - 15%) and mutilation rate, as~     reported by the World Health Organization (WHO) 2001 Annual Report. Drug treatment is one of~     the main treatment methods for this kind of disease, and the dose selected will interfere the~     efficacy and prognosis of the patient.~      Quetiapine fumarate (Seroquel) is a dibenzothiazepine derivative, which is widely used in the~     world. It has the indications in schizophrenia, bipolar mania and depression approved by FDA.~     Quetiapine fumarate has been used in China for almost 10 years, which is in the treatment of~     schizophrenia. The indication of bipolar mania has been approved by SFDA recently.~     Exploration of the relationship between the dose and efficacy has been a hot spot in the~     clinical practice as the drug has a broad action spectrum and wide dose range~     (200mg/d－800mg/d).~      Brain-derived neurotrophic factor (BDNF) plays an important role in the pathophysiology of~     bipolar disorder. Some clinical studies indicate the blood BDNF level decreased during the~     depression phase in the bipolar disorder, and the blood BDNF level is negative proportional~     to the severity of the depression; and the same phenomenon was found, i.e. the blood BDNF~     level decreased during the manic phase in the bipolar disorder, and the blood BDNF level is~     negative proportional to the severity of the mania. Quetiapine fumarate was found to reduce~     the decreasing of the expression of BDNF in the rat hippocampus and brain mantle in some~     animal experiments, indicating quetiapine fumarate has the possibility on potential~     interfering BDNF in the treatment. However, few study on comparison of the blood BDNF level~     between pre and post treatment in the bipolar disorder was conducted.~   "
208085|NCT00837330|"~     This Phase I/II safety study is designed to investigate the safety and efficacy of~     ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a~     potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels~     under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of~     normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the~     treatment of wet age-related macular degeneration (AMD) and is injected directly into the~     eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated~     similarity between the disease mechanisms involved in both wet AMD and PCV, we believe~     ranibizumab will have a beneficial effect on visual function in patients with PCV.~   "
208086|NCT00837317|"~     The purpose of this study is to compare the effects of the consumption of different oils~     (olive oil, sunflower oil, sunflower plus dimethyl-polysiloxane, sunflower plus phenols)~     previously submitted to heating in postprandial endothelial function, inflammation and~     oxidative stress in healthy young men.~   "
208088|NCT00837291|"~     This study will test the effectiveness of CF101 in treating the symptoms of osteoarthritis~     (OA) of the knee. Eligible patients will be given either CF101 or matching placebo tablets~     and their symptoms will be evaluated over the 12 week treatment period.~   "
208089|NCT00837278|"~     The objective of the study is to compare maternal levels of cytokines and angiogenic factors~     in IVF vs spontaneously conceived singleton pregnancies. The null hypothesis is that there~     will be no significant difference.~   "
208090|NCT00837265|"~     Determination of the effect of Neugranin on the duration and severity of severe neutropenia.~   "
208091|NCT00837252|"~     Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation~     of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its~     own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss.~     The pathogenesis of CSC is complex; however, systemic androgens have been implicated.~     Finasteride is an anti-androgen medication that is widely used in the treatment of various~     conditions. The objective of this study was to investigate the safety and potential efficacy~     of oral finasteride as a treatment for chronic CSC.~      Five participants with chronic CSC were enrolled into this uncontrolled, unmasked, Phase I/II~     study. An oral dose of finasteride, 5 mg daily, was administered to all participants for~     three months.~      Following this, finasteride was withheld and participants were observed for another three~     months. If a participant experienced a beneficial effect during the period in which he~     received finasteride and then experienced a relapse during the observation period,~     finasteride was re-instituted for the remaining period of the study. Relapse was defined as a~     return to the baseline maximum lesion height and/or return to baseline lesion volume.~   "
208092|NCT00837239|"~     This protocol is part of a larger grant funded by the NCI to create an international research~     center to study traditional Chinese medicine (TCM). All of the patients enrolled in this~     study will be treated at the Cancer Hospital, Fudan University, our sister institution in~     Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the~     Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance~     through the U.S. Department of Health & Human Services (Approved: April 25, 2002). The~     research nurses have received training at MDACC and will receive regular oversight by MDACC~     personnel.~      Primary End Point:~      1. Determine the efficacy of huachansu as measured by progression free survival at 4 months.~      Secondary End Points:~        1. Examine the feasibility and safety of treatment using huachansu in combination with~          gemcitabine in patients with pancreatic cancer.~        2. Determine clinical efficacy by other measures including tumor response, 6-month~          survival, and changes in quality of life (QOL) in patients with pancreatic cancer.~        3. Monitor patient blood levels of the three main cardiac glycosides that are in huachansu~          (bufalin, cinobufagin, and resibufogenin). This information will provide evidence to~          delineate the role of these cardiac glycosides in antitumor activity.~   "
208093|NCT00837226|"~     The purpose of this study is to determine if there is an effect on the eye pressure from~     extreme weight loss by bariatric procedures. The hypothesis is that excess fat in the orbit~     of the eye compresses on the outflow system, which causes an elevated eye pressure. This can~     have many consequences, including the risk for glaucoma. We hope to establish if there is an~     effect between eye pressure and weight.~   "
208094|NCT00837213|"~     To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin~     vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of~     moderate acne~   "
208095|NCT00837200|"~     This is an exploratory study to study the efficacy of combination regimen of~     Oncaspar/Doxil/Decadron (ODD) in patients with refractory lymphoid malignancies. Patients~     with any form of lymphoid malignancy will be eligible: acute lymphoblastic leukemia, chronic~     lymphocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma and plasma~     cell leukemia. Patients must have failed standard regimens for their cancers and could have~     had unlimited number of prior regimens. Patients will be staged appropriately for their~     disease with clinical examination, laboratory tests, and imaging studies. Both Oncaspar and~     Doxil will be given on day 1 and 15. Patients will be clinically evaluated prior to each~     cycle and will have disease assessments every 2 cycles. Responding patients will continue~     therapy until disease progression or excessive toxicity. Responders who are candidates for~     allogenic stem cell transplantation could go to conditioning chemotherapy and stem cell~     transplant after 4 cycles of ODD.~   "
208096|NCT00837187|"~     In a recent study by Yuen et al it was shown that preoperative intranasal administration of~     dexmedetomidine is a useful alternative for oral midazolam in children. However, there is no~     information on the pharmacokinetics of dexmedetomidine after intranasal administration.~      The aim of this study is to investigate the comparative pharmacokinetics of intranasally and~     intravenously administered dexmedetomidine in healthy volunteers. The absolute~     bioavailability of intranasally administered dexmedetomidine will be calculated. In addition,~     we will report the effects of intranasally and intravenously administered dexmedetomidine on~     plasma catecholamine levels, systemic blood pressure, heart rate and sedation. We will also~     monitor the local and systemic safety and tolerability of intranasally administered~     dexmedetomidine.~   "
208097|NCT00837174|"~     The purpose of this study is to determine the rate of response to the drugs bortezomib~     (Velcade) and vorinostat (Zolinza), when used in combination, in patients with relapsed~     (recurrent) and/or refractory (difficult to treat) non-Hodgkin Lymphoma, and to determine the~     safety and tolerability of this regimen.~   "
208098|NCT00837161|"~     Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in~     reproductive aged women and are the most common cause of hysterectomy in the United States.~     Women are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid~     surgery. This study is the first step in this quest. We will study the novel use of magnetic~     resonance imaging (MRI) in enhancing the safety of the FDA approved technique to treat~     fibroids called High Intensity Focused Ultrasound (HIFU). The term 'high intensity focused~     ultrasound' means using ultrasound to heat and to thermally destroy tissue, in this case,~     uterine fibroids. The MRI system will allow us to watch the ultrasound path during treatment~     and monitor the temperature increase in the fibroid tissue that comes during the procedure.~      In this pilot study, women with symptomatic fibroids will undergo MRI guided HIFU and then~     have a hysterectomy. This will allow us to confirm studies done in animals which show that it~     is possible to destroy specific tissue without harming normal tissue surrounding the targeted~     area.~      The purpose of this clinical study is to confirm the safety and treatment capabilities of the~     Philips MR guided HIFU system for ablation of uterine fibroids. This is a single arm pilot~     study of 10 women who will undergo hysterectomy after the HIFU procedure. This study design~     of hysterectomy after treatment has been requested by the FDA as part of IDE approval for~     this new device and mirrors what has been required for similar devices. Safety will be~     assessed by evaluating treatment accuracy, complications, and adverse events. Treatment~     capabilities will be assessed by evaluating the fibroid volume ablated and other factors~     related to the procedure feasibility and acceptance including procedure duration, time to~     return to normal activity, and pain scores at the time of the procedure.~      Study population~      The Philips MR-HIFU System is intended for ablation of uterine fibroid tissue in pre- or~     perimenopausal women with symptomatic uterine fibroids who desire a uterine-sparing~     procedure. Patients must have completed child bearing prior to enrolling in this study.~     Patients will be recruited by referral to gynecology and interventional radiology at the NIH~     Clinical Center. Candidates for enrollment will already have symptomatic uterine leiomyomas~     and be willing to undergo hysterectomy for treatment. It is estimated that of apparently~     eligible subjects, at least 30 women will have to be screened in person in order to identify~     10 who will be eligible for this study. Other studies of fibroid treatments are currently~     ongoing at the NIH. Women who have been interested in, but have not been selected for~     enrollment in those studies and who appear to be eligible to this study will be contacted for~     potential enrollment.~      Study design:~      This study is a multi-center, single arm trial evaluating the safety and treatment~     capabilities of the Philips MR-guided HIFU system in the treatment of symptomatic uterine~     fibroid patients who are otherwise healthy women. All patients enrolled in the study will~     undergo hysterectomy within a window of 30 days following HIFU treatment. Patients who have~     symptomatic uterine fibroids, meet clinical indications for hysterectomy, are eligible~     according to the inclusion and exclusion criteria and provide informed consent will be~     enrolled in this study. This study design of treatment followed by hysterectomy has been~     requested by the FDA as part of IDE approval for this new device and mirrors what has been~     required for similar devices. It is anticipated that women will participate in the study for~     a 3 month period to include the screening, HIFU treatment, hysterectomy and post hysterectomy~     follow-up.~      The methodology used for this HIFU device capitalizes on the thermal properties of volumetric~     ablation rather than point ablation used by other focused ultrasound systems. Thus it is~     anticipated that this device will have a shorter treatment time compared to other HIFU~     machines. This HIFU system, via real-time MR thermometry monitoring, has automated thermal~     feedback during the procedure which may enhance safety. This pilot study will not only assess~     the safety of this device but will enable us to delineate the treatment capabilities of this~     system for future use in patients who want uterine sparing non-surgical treatment for~     symptomatic fibroids.~   "
208099|NCT00837148|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     sorafenib and dacarbazine has on sarcoma. Recurrent sarcoma is difficult to treat. Standard~     chemotherapy drugs can be toxic, and the length of benefit is usually short. As a result, we~     need new treatments for sarcoma. Sorafenib is a new type of targeted chemotherapy that~     attacks specific proteins (including raf and VEGF receptor) in cells. We hope that by~     blocking these proteins we can cause the tumor to shrink. Sorafenib is also known as BAY~     43-9006 and by the trade name Nexavar®. The FDA approved sorafenib in December of 2005 to~     treat patients with kidney cancer and in November of 2007 to treat patients with liver~     cancer. This drug is not approved by the U.S. Food and Drug Administration (FDA) or any other~     licensing authority for the treatment of sarcoma and is therefore considered to be~     experimental in this setting.~   "
208122|NCT00836849|"~     The objective of this study is to compare the rate and extent of absorption of sertraline~     hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg~     tablet under fasting conditions.~   "
208138|NCT00836641|"~     Asthma is a major health problem in preschool children. Infections by pneumococci a the most~     frequent cause of airway infections, which tend to cause worsening of asthma. Vaccination~     against pneumococci is recommended by scientific boards and the medical community, in order~     to reduce the burden of disease. Data on the immunogenicity and safety of pneumococcal~     immunization in preschool asthmatics are scarce.~   "
208100|NCT00837135|"~     The purpose of this study is to determine if it is safe to add multiple immunotherapies to~     standard chemotherapy and radiation for treating pancreatic cancer tumors that cannot be~     completely removed by surgery.~        1. GI-4000 Vaccination:~           The first involves a vaccine, which is an injection (shot) that teaches your immune~          system to attack foreign invaders. The vaccine we will use is called GI-4000 - a~          vaccine composed of yeast that is made to carry the same proteins (called mutated Ras~          proteins) found in some pancreatic cancer cells.~        2. Adoptive T-cell Transfer:~      The second type of immunotherapy in this study is called adoptive T-cell transfer. This~     involves collecting a specific type of white blood cells from you (called T-cells)and~     growing T-cells grown in a lab which may help the research participants' immune systems~     recover more quickly after chemotherapy, and possibly improved response to other~     immunotherapies.~      We hope that studying these agents together will teach us how to help the immune system fight~     pancreatic cancer.~   "
208101|NCT00837122|"~     Background:~        -  Type 2 diabetes (T2D) and associated complications are major contributors to the global~          disease burden. T2D is already a major health threat in populations in developed~          countries and is rapidly taking hold in the developing world.~        -  It is believed that understanding the complex interplay between genetic and lifestyle~          characteristics in the etiology of T2D and related complications will lead to the~          development of better preventive and therapeutic strategies. In Addition, the results of~          this project will facilitate our understanding of causes of diabetes in African~          Americans, other US and world populations~      Objectives:~        -  To conduct a genome-wide association study (GWAS) to identify susceptibility genetic~          variants for diabetes among the Yoruba people in Ibadan, Nigeria.~        -  To enroll and examine 300 unrelated cases of T2D and 300 ethnicity-matched Yoruba~          controls.~        -  To conduct resequencing of positional candidate gene/loci to identify likely functional~          variants in a subset of the cohort.~        -  To conduct replication studies of the top-100 scoring variants in three independent~          African and European ancestry samples.~        -  To investigate whether diabetes-associated variants discovered in European populations~          increase diabetes risk in West Africans.~      Eligibility:~        -  Patients 25 years of age with confirmed T2D who are newly diagnosed or on treatment of~          Yoruba ethnicity in Ibadan, Nigeria. Control subjects are nondiabetics ethnically~          matched to patients.~      Design:~        -  The study design for both patients and controls consists of the following steps:~        -  Discuss informed consent process and obtain signed informed consent form. Informed~          consent will be administered by trained clinic staff.~        -  Assign study ID (barcode)~        -  Administer questionnaires~        -  Obtain spot urine sample~        -  Measure blood pressure~        -  Obtain anthropometric measurements including body composition~        -  Perform finger prick for blood glucose level~        -  Obtain venous blood samples~        -  Perform eye examination~        -  On the following day, perform confirmatory blood glucose for the small subset of~          participants requiring confirmation of previous test result DNA extraction of stored~          samples will be done at either the National Institutes of Health or the laboratory in~          Nigeria.~        -  GWAS will be conducted using publicly available software packages.~   "
208102|NCT00837109|"~     Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in~     veterans, and that trauma-related nightmares and sleep disturbances are common in veterans~     with PTSD. This is of concern because people with these problems will often use unhealthy~     ways of coping. Although trauma-related nightmares and difficulty sleeping are highly~     distressing, there are helpful treatments that do not involve taking medication. One of these~     treatments teaches specific skills to help people improve their sleep habits and to change~     their nightmares so that they are less upsetting. This treatment can be very helpful and~     research shows that people experience decreases in the frequency and severity of their~     nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and~     quantity after completing treatment. However, because this treatment has only been studied~     with civilians, it is not clear how well this treatment works for veterans.~   "
208103|NCT00837096|"~     The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further~     salvage of the diabetic foot once it has undergone partial amputation. To determine this,~     measures of healing, quality of life, and utilization costs associated with this approach~     will be analyzed. KCI believes that information obtained from this study will show V.A.C.~     NPWT can support efforts involving limb salvage of the diabetic foot, helping an effective,~     cost-efficient healthcare solution.~   "
208104|NCT00837083|"~     This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin)~     in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with~     hypercholesterolemia. Effectiveness is to be evaluated using the difference in LDL~     cholesterol level between the first and the second visit after 12 weeks.~   "
208105|NCT00837070|"~     Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be~     cured by a minimally invasive technique: percutaneous cyst distention and rupture~   "
208106|NCT00837057|"~     Severe sepsis or septic shock with acute kidney injury shows high mortality in intensive care~     unit. A few studies have shown CRRT relating the clinical improvement seems to be related to~     the early initiation of therapy. But there is no consensus for proper time of CRRT may~     improve the prognosis.~      The study is a prospective randomized one center trial comparing two treatments in patients~     suffering from septic shock complicated with acute renal failure admitted to ICU, treated~     either early by CRRT (35 ml/kg/h) or by conventional RRT.~   "
208107|NCT00837044|"~     Migraine headache occurs frequently in women more than men and is associated with symptoms~     not only of significant pain but also of symptoms typically including of photophobia,~     phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from~     lack of concentration, difficulty in word finding or inability to remember. Many of these~     cognitive symptoms seem to be independent of the pain intensity and may occur completely~     separately from the headache pain but can be disabling. It is likely that the frequency and~     importance of cognitive symptoms associated with migraine are underreported.~      The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an~     efficient and accurate measure of cognition during migraine headache. Treximet is a new~     migraine treatment recently FDA approved for the treatment for the relief of acute migraine~     that may be effective for the cognitive symptoms for migraine patients who have a history of~     cognitive dysfunction during a migraine headache. The primary efficacy parameter is to~     evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute~     migraine headache measuring neuropsychological function using the MEWT during the migraine~     and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A~     double blind, placebo-controlled, crossover study was chosen so that each patient may be her~     or his own control.~      It is the intent of this study to determine the type and intensity of cognitive dysfunction~     associated with migraine headache and to what extent that Treximet may relieve the cognitive~     dysfunction in a safe and effective manner.~   "
208108|NCT00837031|"~     To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in~     combination with standard gemcitabine as first-line treatment for patients with metastatic~     pancreatic cancer.~   "
208109|NCT00837018|"~     The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to~     4% of the general population. The patients with OSAS frequently complain of intolerance to~     exercise muscle fatigue and a significant even if they have not been fully characterized in~     the literature.~      The anomalies in the exercise of patients with OSAS could be due to metabolic changes~     (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).~      Our goal is both to determine whether these anomalies exist in patients with OSAS not obese,~     consider their relationship with the alteration of exercise capacity, and their reversibility~     in conventional PPC or by using the effects of physical activity regular.In this study~     Objectives: To establish whether the metabolic and vascular abnormalities associated with~     OSAS are associated with decreased parameters of physical fitness in relation to witnesses~     matched for age, sex and body mass index. Determine the effects of a re-training exercise on~     these parameters compared to the reference treatment, continuous positive pressure.~      Main objective: To compare the exercise capacity of OSAS patients compared with that of~     witnesses matched for age, sex and body mass index.~      Secondary objectives: To compare the effect of conventional treatment by continuous positive~     pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic~     modality most original, physical activity.~      Methodology: Test physiopathological parallel group, controlled, randomized.~   "
208110|NCT00837005|"~     High-dose dobutamine/atropine stress cardiac magnetic resonance imaging (DS-MRI) has been~     incorporated in daily clinical practice for the detection of ischemic heart disease.~      Thus, wall motion abnormalities (WMA) during stress, precede the development of ST-segment~     depression on ECG and of anginal symptoms and aid in the detection of anatomically~     significant coronary artery disease (CAD).~      DS-MRI offers the possibility to integrate myocardial perfusion and wall motion analysis in a~     single examination. In this regard, recent data suggest that the assessment of myocardial~     wall motion and perfusion during a single session may enhance the sensitivity of the~     technique for the diagnosis of CAD.~      However, to date limited data is available on the prognostic value of high-dose DS-MRI in~     large patient cohorts, treated according to current guidelines.~      Assessment of long-term outcome of DS-MRI is important because this test may identify both~     high-risk patients, who would benefit from invasive diagnostic and therapy, and lower-risk~     patients in whom additional procedures and intensive medical follow-up are not required.~      In the present study we aim to determine the value of wall motion and perfusion assessment~     during high-dose dobutamine/atropine MRI in predicting cardiac events.~      In addition, the incremental value of the MR-stress testing results was assessed (inducible~     wall motion, perfusion abnormalities and the combination of both) after the consideration of~     traditional clinical risk factors and baseline ejection fraction.~   "
208111|NCT00836992|"~     RATIONALE: Gathering information about patients' quality of life during radiation therapy for~     cancer may help doctors plan the best treatment.~      PURPOSE: This randomized clinical trial is studying quality of life in patients undergoing~     radiation therapy for primary lung cancer, head and neck cancer, or gastrointestinal cancer.~   "
208112|NCT00836979|"~     This study is a continuation or follow-up of two previous studies (RRISK and RRISK2)~     conducted at the Kaiser Division of Research. This study will invite previous study~     participants, as well as a randomly selected group of Northern California Kaiser Permanente~     Members, to participate in an interview, mailed survey and lab visit. The purpose of this~     study is to examine the risk factors for bladder and pelvic problems.~   "
208113|NCT00836966|"~     The diagnosis of clinically-significant meniscal tears of the knee remains challenging, and~     it is unknown why only some injuries become painful. The limitations of diagnostic magnetic~     resonance imaging result in arthroscopy that is not always beneficial. Elucidation of~     biochemical pathways underlying pain in this condition may aid patient selection for surgery~     and provide pharmacotherapeutic targets. Cytokines may be involved in pain following meniscus~     injury and diagnostic cytokine assay may help physicians differentiate patients that may~     benefit from arthroscopy from those that may not.~   "
208114|NCT00836953|"~     To describe the safety findings from Days 0 to 44 following injection of the 2003-2004~     pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in~     the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to <~     36 months.~      To describe the immunogenicity findings from Days 0 to 44 following injection of the~     2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®,~     given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6~     months to < 36 months~   "
208115|NCT00836940|"~     The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus~     patients.~      The study involves six weeks of wash out period and two weeks run in period for patients~     currently on mono-therapy and a two week run in period only for drug naïve patients.~      This is a placebo controlled study. One of the five treatment arms is placebo. The duration~     of treatment is 12 weeks.~   "
208116|NCT00836927|"~     To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for~     whom a clinical benefit has been established in a prior parent trial (MK-8669-013,~     NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or~     in those who remain in long-term follow-up.~   "
208117|NCT00836914|"~     The purpose of this study is to determine the safety and effect of CAL-101 in subjects with~     allergic rhinitis.~   "
208118|NCT00836901|"~     The objective of this study is to compare the rate and extent of absorption of~     amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin®~     (reference) administered as 1 x 400 mg-57 mg chewable tablet under fed conditions.~   "
208119|NCT00836888|"~     Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and~     multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and~     exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.~   "
208120|NCT00836875|"~     The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal~     drug) when used in children who have invasive aspergillosis (IA) and other rare systemic~     fungal infections.~   "
208121|NCT00836862|"~     This project will bank sera, DNA and vascular specimens from patients undergoing~     arteriovenous fistula creation and revision~   "
208170|NCT00836199|"~     The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term~     abstinence.~   "
208123|NCT00836836|"~     Seizures are a frequent cause of morbidity in the pediatric age group. Uncontrolled seizures~     pose a variety of risks to children, including higher rates of mortality, developmental delay~     and/or regression, and cognitive impairment. The ketogenic diet is a well known treatment~     option for refractory epilepsy. However it is very restrictive and requires strict weighing~     of foods. The modified Atkins diet is a dietary therapy for intractable childhood epilepsy~     that was designed to be a less restrictive alternative to the traditional ketogenic diet.~     Early studies have demonstrated efficacy and safety.There are no randomized trials evaluating~     the efficacy of the modified Atkins diet in children with refractory epilepsy. Hence this~     study has been planned to investigate whether there are clear benefits in terms of seizure~     control in children with refractory epilepsy who are treated with the modified Atkins diet,~     versus controls.~   "
208124|NCT00836823|"~     Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) consists~     of a constellation of symptoms (including voiding, storage, and post-micturition). The impact~     of the LUTS on patients' health-related quality of life is substantial and multifaceted.~     Thus, the therapies aimed at treating BPH are concerned primarily with improving patients'~     symptoms, thereby improving quality of life. When multiple symptoms are present, the level of~     bother associated with individual symptoms varies and patients prioritize their treatment~     goals for symptom relief. A measure that addresses patients' most bothersome symptoms (MBS)~     and evaluation of symptom-specific goal achievements may lead to improved outcomes and~     patient satisfaction to the treatment. The objectives of this study were (1) to assess~     patient-reported MBS and symptom-specific goal achievements (PGA) with medical treatment in~     BPH patients, and (2) to identify factors that influence or have relation to the PGA.~   "
208125|NCT00836810|"~     Polymyalgia Rheumatica (PMR) is a disease that usually affects older people. Patients~     complain of stiffness and pain around the shoulders and hips. The stiffness is more severe in~     the morning.~      Research in Rheumatoid Arthritis (RA), which is also much worse in the mornings, has shown~     that IL−6 (a chemical messenger) peaks in the morning with very low levels in the evening.~     This may explain why stiffness is most severe in the morning. The investigators have recently~     shown that timed release tablet (TRT) prednisone reduced morning IL−6 levels close to normal~     in RA patients.~      In PMR, IL−6 levels are high. Given that both RA and PMR have the same variation of symptoms~     (worse in the morning); it's likely that PMR patients have the same variation in IL−6 levels.~     In a pilot study of 4 patients conducted within our department, IL−6 levels did, indeed, show~     a pattern similar to that found in RA patients, but the number of patients is small and the~     results need to be confirmed.~      PMR is treated with moderate doses of glucocorticoid for about 2 years. While generally~     abolishing symptoms, these doses are very likely to cause adverse effects such as high blood~     pressure, weight gain and diabetes. These side effects are much less frequent when lower~     doses are used but these are not sufficient to control PMR using traditional dosing regimes.~      Therefore, the investigators wish to investigate whether TRT prednisone in PMR will reduce~     IL−6 and morning symptoms similar to those in RA. The investigators think that it will do so,~     and will achieve symptomatic relief at a lower dose. If this is the case, then treating~     patients with lower doses may mean reduced risk of glucocorticoid induced side effects in the~     future.~      Patients will be recruited through the outpatient clinics at the University Hospitals~     Bristol, NHS Foundation Trust, Rheumatology Centre. Each patient will give fully informed~     consent after being given details of the study and a patient information sheet. The research~     doctor will take the consent 2−5 days after this information has been provided and with the~     presence of a witness. The study will consist of the collection and analysis of sequential~     blood samples over a 24 hour period on 2 occasions 2 weeks apart, taking TRT prednisone 7 mg~     / standard release prednisolone 7 mg for the intervening period. The investigators will aim~     to recruit 12 patients in each arm. A single blood sample will be taken when the patient~     comes for a routine review 2 weeks later.~   "
208126|NCT00836797|"~     After extraction of a tooth, the bony socket heals naturally but due to the absent of the~     tooth and any presence of support in the socket, bone resorption occur both vertically and~     bucco lingually or bucco palataly. This bony resorption ultimately effects a lot of things~     like - the support for the adjacent teeth become weak, the shallow ridge makes it difficult~     for future prosthesis retention, and less bony support for any implant placement in the~     future which is the most popular and effective way of tooth replacement now a days. So now a~     days keeping the integrity and contour of the alveolar bony socket is very important for the~     patients future rehabilitation. The use of scaffold will help to maintain the integrity of~     the alveolar bony socket thus provides a vital support for the adjacent teeth, preserve the~     alveolar crest height, maintain the bony contour, helps to prevent bleeding, and most~     importantly it will help in bone regeneration which is the vital factor for future~     rehabilitation.~   "
208127|NCT00836784|"~     This study aimed to validate or invalidate non-inferiority in the plaque removal efficacy of~     old versus new toothbrushes in the hands of 7-9 year old children. This study was conducted~     in 93 Iranian students aged between 7-9 year old.~   "
208128|NCT00836771|"~     Evaluation the nutritional suitability of a based milk infant formula supplemented with~     friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to~     healthy, full term infants compare with an otherwise identical widely used commercially~     available milk based infant formula and/or breast feed~   "
208129|NCT00836758|"~     The purpose of this study is to compare the performance of a CPAP (continuous positive airway~     pressure) device to a clinical polysomnography (PSG) in identifying breathing events in~     patients with obstructive sleep apnea.~   "
208130|NCT00836745|"~     The Sutent® Observational Study is being proposed to assess the real-world usage patterns and~     effectiveness and tolerability of treatment of Indian patients with advanced renal cell~     cancer with Sutent®. Generation of such information is expected to aid everyday clinical~     decision-making by Indian doctors and will add to the body of generalizable evidence.~   "
208131|NCT00836732|"~     The aim is to study small genetic alterations induced by cell culture in human mesenchymal~     stem cells in GMP condition.~   "
208132|NCT00836719|"~     This study is an open label 6 month study. All subjects will be treated with Polyphenon E~     (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be~     safety. Secondary outcomes are the change in NAA levels over 6 months as measured by~     MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E~     will protect neurons and thus increase NAA levels.~   "
208133|NCT00836706|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 500~     mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1~     x 500 mg tablet) in healthy adult subjects under non-fasting conditions.~   "
208134|NCT00836693|"~     The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg~     administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5~     (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on~     tolerability.~   "
214013|NCT00758550|"~     The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof~     Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.~   "
208141|NCT00836589|"~     The objective of this study is to confirm the long-term safety and reliability of the Linox~     Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully~     characterize ICD lead failures, from implant through 5 years, including those failures~     contributing to patients losing pacing or defibrillation therapy.~   "
208142|NCT00836576|"~     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the~     oral bioavailability of a test benazepril HCl formulation (TEVA Pharmaceutical Industries~     Ltd.) to an equivalent oral dose of the commercially available benazepril HCl (Lotensin®,~     Novartis Pharmaceuticals Corporation) in a test population of 40 adults under fasting~     conditions.~   "
208143|NCT00836563|"~     The purpose of this study is to determine whether upper arm vessels increase in size~     following forearm loop arteriovenous graft placement, and if they do, characterize the timing~     of these changes~   "
208144|NCT00836550|"~     This study evaluated the educational effectiveness of a youth-friendly pre-test video~     (derived from a previous qualitative study) and compared it with in-person HIV pre-test~     counseling. A convenience sample of 200 medically stable individuals between the ages of 15~     and 21 presenting to an urban ED were recruited to participate in this study and randomized~     into 2 groups. Individuals were eligible if they were English-speaking, sexually active and~     able to consent. All participants completed a sexual risk factor and demographic survey.~     Group 1 completed a validated pre-test knowledge measure, viewed the HIV education video then~     completed a post-test knowledge measure. Group 2 completed the same knowledge measures, but~     received pre-test HIV counseling from a trained public health advocate. HIV testing was~     optional~   "
208145|NCT00836537|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 40 mg~     Benazepril Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 40 mg~     LOTENSIN® Tablets by Novartis Pharmaceuticals following a single oral dose (1 x 40 mg) in~     healthy adult volunteers under non-fasting conditions.~   "
208146|NCT00836524|"~     Objective: To investigate the role of maternal serum YKL-40 and uterine artery doppler, at~     gestational age 12, 20, 25 and 32 weeks, and the relation to preeclampsia and intrauterine~     growth restriction. The serum marker YKL-40 is related to conditions involving inflammation,~     infection, tissue remodeling, fibrosis and cancer. IUGR and preeclampsia are known to be~     related to inflammation and tissue remodeling.~      Methods: women attending screening for downs syndrome is scanned with uterine artery doppler~     and delivered blood samples at GA 12, 20, 25 and 32 respectively. When pregnancy outcome is~     registered by medical records blood samples are retrieved and analyzed for serum YKL-40.~     Serum YKL-40 are correlated to the presence of bilateral notching, preeclampsia and different~     degrees of intrauterine growth restriction.~   "
208147|NCT00836498|"~     This is a Phase I clinical trial including 2 parts to evaluate the safety and immune response~     to RotaTeq™ /placebo in subjects of 65 to 80 years of age. In Part I, approximately 60~     subjects in US will be randomly assigned to 1 of 2 treatment groups receiving 3 doses of~     RotaTeq™ or placebo. In Part II, approximately 200 subjects internationally will be randomly~     assigned to 1 of 3 treatment groups. Part II will start after Part I data analysis is~     reviewed and approved by the FDA/CBER, the Safety Evaluation Committee (SEC) and other~     regulatory agencies. Duration for the entire study will be approximately 4 years.~      Note: As the result of a business decision by the Sponsor, the study did not proceed with~     Part II. Therefore, this report includes the results for Part I only.~   "
208148|NCT00836485|"~     This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be~     evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.~   "
208149|NCT00836472|"~     The objective of this study is to compare the rate and extent of absorption of~     Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference)~     administered as 1 x 5 mg/500 mg film-coated tablet under fasting conditions.~   "
208150|NCT00836459|"~     Adults that increase their physical activity can improve their health, and reduce future~     risks to health, but long−term changes are difficult to sustain. This study assesses whether~     it is worth providing further support, 3 months after giving initial advice, to those who~     have managed to do more physical activity. All participants will initially be given an~     interactive DVD. A researcher from Sheffield Hallam University will provide two telephone~     follow ups at one month intervals to assess physical activity levels. Only those that have~     increased their physical activity at this point will remain in the study. These participants~     will receive a mini booster, a full booster or no booster. The mini booster consists of~     a two telephone calls one month apart to discuss physical activity and usage of the DVD. A~     full booster consists of a face−to−face meeting with the facilitator at the same intervals.~     The purpose of these booster sessions is to help the individual to maintain their increase in~     physical activity. The investigators will measure the differences in physical activity,~     quality of life and costs, associated with the booster interventions, 3 months and 9 months~     from randomisation. The research will be carried out in 20 of the most deprived~     neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high~     levels of economic deprivation, low levels of physical activity, poorer health and shorter~     life expectancy. Participants will be recruited through general practices and community~     groups, as well as by postal invitation to ensure the participation of minority ethnic groups~     and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a~     range of facilities and activities to promote physical activity and variations in access to~     these between neighbourhoods will make it possible to examine whether the effectiveness of~     the intervention is modified by access to community facilities.~   "
208151|NCT00836446|"~     Childhood obesity is a public health problem; in Mexican children a high prevalence of~     cardiovascular risk factors are present. Physical activity has been proposed as a strategy to~     reduce this risk. We conducted a pre-posttest intervention study of 214 school-aged Mexican~     children (4th to 6th grade), to assess the effects of two physical activity routines with~     different duration and intensity (40 minute aerobic routine vs. 20 minute routine) on~     cardiovascular risk markers. Physical activity routines were assigned randomly to two public~     schools in Toluca, Mexico (20 min: group 1 (n= 117), 40 min: group 2 (n=97)). The routines~     were implemented Monday through Friday for 12 weeks. Nutrition assessment was done before and~     after the intervention and included anthropometric measurements (weight, height, body mass~     index, waist circumference and body composition), blood pressure and biochemical analysis~     (triglycerides, total cholesterol LDL-cholesterol, HDL-Cholesterol, glucose and insulin).~     Heart rate was monitored 3 times during the intervention to evaluate the routine´s intensity.~   "
208171|NCT00836186|"~     To assess the magnitude and frequency of changes in chemo/cytokine expression in women~     receiving radiation treatment. To asses the impact of race/ethnicity on the magnitude and~     frequency of changes in chemo/cytokine expression during radiation therapy for breast cancer.~     And finally to assess the interaction between radiation-induced chemo/cytokine expression~     changes, and race/ethnicity, with respect to normal tissue reactions to radiation and~     tumor-associated outcomes.~   "
208152|NCT00836433|"~     This is a randomized trial of 2 nursing home staff educational approaches to reduce falls in~     VA nursing home (CLC) residents. One is a traditional falls education program using web-based~     modules, feedback of quality indicators, and meetings with influential peers. The other is a~     12 week program that trains staff to form better connections and use effective communication~     strategies with a diverse network of co-workers, so that problem solving about resident~     problems is enhanced. The study will test whether the second intervention increases the~     effectiveness of the traditional falls education program.~   "
208153|NCT00836420|"~     Patients with fulminant hepatic failure (FHF) often develop cerebral edema, high intracranial~     pressure (ICP)that may result in fatal brain damage. The aim in this protocol is to determine~     if a rise in the brain concentration of glutamate, lactate and pyruvate are involved in~     development of surges of high ICP in patients with FHF. The study is observatory in nature~     and also record the influence of any intervention that may e instituted during the course of~     the critical illness.~   "
208154|NCT00836407|"~     Research Hypothesis: Ipilimumab (an antibody that blocks negative signals to T cells)~     administered alone or in combination with a pancreatic cancer vaccine (allogeneic pancreatic~     tumor cells transfected with a GM-CSF gene), has an acceptable safety profile in subjects~     with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.~      Primary Objective: To determine the safety profile of ipilimumab alone or in combination with~     a pancreatic cancer vaccine in subjects with locally advanced, unresectable or metastatic~     pancreatic adenocarcinoma.~      Secondary Objectives:~        -  To estimate overall survival (OS) which will serve as the primary efficacy signal.~        -  To explore an association of T cell responses and immunological responses with OS in~          patients receiving treatment.~        -  To estimate overall response rate (ORR), immune related best overall response rate~          (irBOR), progression free survival (PFS), and duration of response in patients receiving~          treatment.~        -  To explore an association between immune-related adverse events (IRAEs) and ORR.~        -  To measure tumor marker kinetics (CA 19-9) in patients receiving treatment.~   "
208155|NCT00836394|"~     Juvenile idiopathic arthritis (JIA) is one of the most common chronic illnesses in children,~     with recent data suggesting that 1 to 4 in 1000 Canadian children and youth cope with the~     condition. Many JIA children will enter adulthood with permanent joint damage5. In parallel,~     a significant number are affected by deficits of muscle function. In addition to the impact~     on physical function, muscles play an important role in maintaining joint health. The overall~     aim of this proposal is to evaluate a novel therapeutic intervention - whole body vibration~     (WBV) - for its ability to improve muscle function and the biomechanics of lower extremity~     joints in JIA in order to prevent joint degeneration.~   "
208156|NCT00836381|"~     For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A~     recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB~     concluded that the drugs provide significant improvements in OAB symptoms compared with~     placebo but that the benefits are of limited clinical significance. The analysis questioned~     the clinical significance of the trial results, one reason for which was the lack of data on~     the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures~     of treatment success may be meaningful to clinicians but often have little meaning to~     patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of~     a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun~     to recognize the value of PROs but still overlook the treatment efficacy in terms of~     patient-reported goal achievement (PGA).~      Patients with OAB have combination of symptoms and the extent to which individual OAB~     symptoms affect patients varies. Also each patient can have different goal for the treatment.~     Therefore, assessing the degree of goal achievement in each patient can provide a new aspect~     of treatment benefit.~      This controlled study will advance the understanding of OAB in terms of patient-centered~     treatments goals and goal achievement and will provide a new aspect of treatment benefit.~   "
208157|NCT00836368|"~     Purpose: This is a non-masked study with a primary endpoint of in vitro basophil activation~     by the allergen D. farinae, comparing basophil activation before and after seven days of~     supplementation. Secondary endpoints will include circulating antioxidant levels (tocopherols~     and metabolites), in vitro basophil activation to IgG anti-IgE and to~     N-formyl-methionyl-leucyl-phenylalanine (f-met-leu-phe), and monocyte and basophil~     responsiveness to in vitro endotoxin challenge.~      Participants: Twenty allergic asthmatic volunteers Procedures (methods): Volunteers will be~     given 1200 mg of a gamma tocopherol enriched supplement, a commercially available supplement~     form of vitamin E. Study participants will undergo assessment of general health, lung~     function assessment, symptom scoring, and epicutaneous skin test to allergens at baseline and~     after supplementation. Blood samples will be collected at baseline and after 7 days of~     gamma-T treatment.~   "
208158|NCT00836355|"~     The purpose of this study is to investigate whether enoxaparin, minocycline, or both~     medications in combination may help in recovery from acute stroke.~      Enoxaparin (brand name Lovenox®) is a medication approved for use in humans to prevent and to~     treat blood clots in deep veins in certain specific medical situations. Minocycline (brand~     name Minocin®) is a tetracycline antibiotic approved to treat a number of bacterial~     infections in humans. The investigators are studying these medications in acute human stroke~     because they have each been separately shown to reduce the amount of injured brain tissue in~     rats made to have acute ischemic stroke experimentally. In a human trial comparing~     minocycline with placebo (a sugar pill) acute ischemic stroke patients who took minocycline~     had better recovery after 1 week, 1 month and 3 months than patients who took placebo.~   "
208159|NCT00836342|"~     The purpose of this study is to determine the difference of skin carotenoid levels between~     subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell~     carcinomas (BCC) and a control group.~   "
208160|NCT00836329|"~     Preliminary studies have shown that people with diabetes who undergo heart surgery may have a~     higher risk of developing cognitive functioning problems, including memory problems, than~     people without diabetes who undergo heart surgery. Among people with diabetes, however, those~     who control their blood sugar levels in a more intensive way during and after heart surgery~     may have better neurological outcomes than those who use a standard method of controlling~     their blood sugar levels. This study will compare the effectiveness of using a traditional~     method of blood sugar control versus a more intensive method of blood sugar control during~     and after heart surgery for improving neurological outcomes in people with diabetes.~   "
208162|NCT00836303|"~     This study will assess the effectiveness of a culturally-responsive intervention to increase~     colorectal cancer (CRC) screening among Latino immigrants in a primary care clinic setting of~     a large municipal Hospital in New York City. propose a randomized, control trial to determine~     if a video-based intervention, that educates and activates the patient and the provider via~     the patient, will increase rates of CRC screening referrals compared to a control group.~      Colorectal cancer remains one of the most prevalent cancers among the general population, as~     well as in the Latino population, in the United States. There are serious disparities in CRC~     screening rates between different races and socio-demographic populations (American Cancer~     Society: Colorectal Cancer Facts and Figures - Special Edition 2005). Latino immigrants are~     one of the populations most affected by the lack of screening, reducing their relative~     benefit from preventive CRC services. This study will use a modified version of an~     intervention developed and studied by Pignone (11), with changes made to be tailored~     specifically to the Latino immigrant population. The outcomes measured will include referral~     for CRC screening and adherence with providers' referrals. In addition, the investigators~     will measure screening rates for other cancer screening tests to assess if the CRC~     intervention displaces or facilitates other cancer screening. A sample of Latino immigrants~     seeking care at the primary care clinic of Bellevue Hospital will be accrued through a~     process of consecutive sampling until reaching the proposed sample size of 101 patients in~     each group (alpha 0.05 and power of 80%). To analyze the effectiveness of the intervention~     the investigators will use the z-test and will report the difference in proportion between~     the intervention and the control group with a 95% CI, adjusting for intra-class correlations~     and covariates. A repeated measurement analysis with logistic regression will be used to~     examine the effects of covariates.~   "
208163|NCT00836290|"~     Project PLUS tests an HIV risk reduction/adherence behavioral intervention with HIV-infected~     individuals in Connecticut prisons. Participants are randomly assigned to one of three~     groups: prior to release from incarceration (Group 1), after release from incarceration~     (Group 2), and treatment-as-usual (Group 3). We hypothesize that the intervention groups~     (Groups 1 & 2) will demonstrate significantly greater knowledge regarding drug- and sex-~     related HIV risk behavior and HIV medication adherence, greater motivation to reduce HIV risk~     behavior and improve HIV medication adherence, and enhanced skills for engaging in HIV risk~     reduction behavior and HIV medication adherence vs. the treatment-as-usual group. We will~     also compare these outcomes between Groups 1 and 2.~   "
208164|NCT00836277|"~     This study proposes a single-arm, phase II study of irinotecan with panitumumab as~     second-line therapy for patients with advanced esophageal adenocarcinoma. Efficacy will be~     assessed by response rate, with an exploratory outcome endpoint of time to progression (as~     panitumumab may result in prolonged stable disease). In addition to the usual safety~     assessments, molecular correlates will be carried out in order to search for pharmacodynamic~     and pharmacogenomic features that may correlate with response. Measures of host/patient~     immune function will be assessed by evaluating the relationship between Fc receptor~     polymorphisms and response in patients treated with panitumumab. Measures of EGFR protein and~     phosphoprotein expression by immunohistochemical- (IHC-) staining, K-ras mutation status1 and~     reverse-phase protein arrays (RPPA) and EGFR gene amplification by fluorescence in situ~     hybridization (FISH) will be assessed as exploratory correlates.~   "
208165|NCT00836264|"~     Intravenous (IV) morphine requirement for immediate postoperative pain control depends upon~     the complex interplay of patient history, wound severity, environment, and genetics. Even for~     relatively uniform stimulus intensity, such as that associated with tonsillectomy and~     adenoidectomy (T&A), there can be marked individual variability in response to morphine. Some~     patients are refractory to standard doses and need increased amounts. Others are sensitive,~     require less drug to attain acceptable pain levels, and/or experience unwanted side effects~     that limit dosing. A significant number must be switched to different analgesics altogether.~     Despite the long clinical history of morphine as a postoperative analgesic, researchers have~     only begun to examine the origins of response variability.~      The investigators will look at 2000 retrospective Tonsillectomy and Adenoidectomy cases and~     using this data and incorporating additional patient, surgical, and environmental factors~     that may contribute to response variability, the investigators then propose a prospective~     genome-wide association (GWA) study of 1500 children ages 4 to 18 y treated with IV morphine~     sulfate for day surgery T&A.~   "
208166|NCT00836251|"~     Aim 1: To evaluate the effect of antipsychotic treatment group on Activity Energy~     Expenditure. The project hypothesizes that subjects treated with olanzapine will demonstrate~     a greater decrease in AEE over time than subjects treated with ziprasidone, due at least in~     part to sedating effects of olanzapine.~      Aim 2: To evaluate the effect of antipsychotic treatment group on Energy Intake. The project~     hypothesizes that subjects treated with olanzapine will demonstrate a greater increase in EI~     over time than subjects treated with ziprasidone, based on higher histamine type 1 (H1)~     receptor affinity of olanzapine and the relationship between H1 affinity and hunger and/or~     satiety.~   "
208167|NCT00836238|"~     The goal of this research study is to learn if your answers to questions during an interview~     can help researchers predict how well you function physically and if you are at a high risk~     for falls.~      Primary Objectives:~      -To determine how accurately a simple questionnaire can predict three objective measures of~     function in elderly patients with prostate cancer.~      Secondary Objectives:~        -  To assess the correlations between three functional tests and the number of~          self-reported falls in elderly patients with prostate cancer.~        -  To determine risk factors related to number of falls in elderly prostate cancer~          patients.~   "
208168|NCT00836225|"~     The primary purpose of this trial is to assess the safety and tolerability of ISIS-SGLT2Rx~     when given at increasing single doses and to assess the safety and tolerability of the same~     doses when given multiple times.~   "
208169|NCT00836212|"~     Background~      Low concentrations of protease inhibitors (PIs) or nonnucleoside reverse transcriptase~     inhibitors (NNRTIs) are associated with an increased risk of virological failure. Likewise,~     excessive antiretroviral drug concentrations increase the risk of toxicity. Therapeutic drug~     monitoring (TDM) may identify and correct excessively high or low PI and/or NNRTI~     concentrations, and thus minimize toxicity and risk of treatment failure. Treatment~     guidelines only recommend using TDM to help optimize ARV therapy in selected patients, and~     there are no clear recommendations to guide the clinician who decides to adjust drug doses.~     Prospective studies have demonstrated the relationship between EFV plasma concentration and~     neuropsychiatric symptoms. Moreover, EFV is metabolized mainly by cytochrome P450 2B6 and its~     concentration was reported to be associated with the CYP2B6 516GrT genetic polymorphism.~      For drugs such as EFV or LPV/r, lower doses than the ones validated for standard clinical use~     have demonstrated efficacy in dose-ranging studies.~      The investigators will use a standardised algorithm to reduce doses in patients with plasma~     EFV or LPV/r concentration above percentile 75. This algorithm is based on a Bayesian~     approach from the pharmacology unit in Lausanne. The investigators hypothesize that a dosage~     individualisation is feasible and safe.~      2.2 Study Aims~      The investigators aim at testing a simplified algorithm for dose reduction in patients with~     documented virological efficacy, treated by a stable LPV/r or EFV based regimen with elevated~     plasma concentration of these drugs.~      Study Design~      Prospective open label study in which all eligible patients screened with a plasma drug~     concentration of either EFV or LPV/r above percentile 75 will be included. After confirmation~     of the results at baseline, patients will be offered to decrease drug dosage by a third or a~     half according to a standardised algorithm. All patients will undergo HIVRNA, biochemistry~     and validated questionnaires after 3 and 6 months to assess the safety and the benefit of~     this strategy.~   "
208172|NCT00836173|"~     The purpose of this study is to find out what effects, good and/or bad; rituximab,~     ifosfamide, carboplatin and etoposide (RICE) followed by gallium nitrate, rituximab and~     dexamethasone (GARD) have on diffuse large B cell lymphoma.~      This research is being done to try to find a more effective treatment for this type of~     cancer. We want to know whether treatment with rituximab, ifosfamide, carboplatin and~     etoposide (RICE) then followed by gallium nitrate, rituximab and dexamethasone (GARD) will~     improve survival.~      Rituximab, ifosfamide, carboplatin and etoposide (RICE) are part of the usual treatment for~     diffuse large B-cell lymphoma.~      Gallium nitrate, rituximab and dexamethasone (GARD) in lymphoma is experimental.~   "
208173|NCT00836160|"~     This is an observational prospective study that investigates only daily practice. The~     prescription of anti-cancer medicine is separated from the decision to include the patient in~     this study. In addition, the assignment of the patient to a particular therapy or therapeutic~     strategy is not decided in advance by this study protocol, but falls within current practice.~      The patient who fulfils eligible criteria will be enrolled when starts to receive the~     second-line EGFR-TKI therapy. The frequency of tumor response evaluation by RECIST criteria~     follows the investigator's discretion as daily practice.~   "
208174|NCT00836147|"~     This trial will explore the efficacy and safety of 250ng Juvista per Linear cm, administered~     by intradermal injection following the excision of ear lobe keloids. Keloids commonly occur~     after ear piercing and are usually bilateral.One ear lobe will be treated with Juvist and one~     with placebo.~   "
208175|NCT00836134|"~     The purpose of this study is to compare the effectiveness of local infiltration to an~     ultrasound guided nerve block placed by the anesthesiologist for children undergoing~     umbilical hernia repair.~      This is a double-cohort, double blinded, randomized study comparing local infiltration to~     ultrasound-guided rectus sheath block in children 1 to 17 years of age undergoing epigastric~     or umbilical hernia repair.~      We will first compare pain scores to see if one method is more adequate then the other in~     providing post-op analgesia. Our second aim is to compare morphine consumption between the~     two groups.~      Our third aim is to measure the levels of local anesthetic in the blood following local~     anesthetic infiltration or USGRSB.~   "
208176|NCT00836121|"~     The investigators report a case of a 39-year-old man who presented an anterior mediastinal~     cystic mature teratoma. Those kind of tumor contain elements derived from more than one of~     the three primary germ layers (ectoderm, mesoderm, endoderm), frequently arranged in a~     haphazard manner. They arise from totipotent cells and, therefore, are primarily found in~     gonads, and more rarely in primitive cells kidnapped in other parts of the body. The tissues~     are immature to well differentiated and foreign to the anatomic site. Mature teratomas are~     either cystic or solid, although the cystic presentation predominates in gonadal sites.~     Benign teratomas are the most common mediastinal germ cell tumor, accounting 70% of the~     mediastinal germ cell tumors in children and 60% of those in adults. Immature teratomas are~     potentially malignant tumors; their prognosis is influenced by the anatomic site of the~     tumor, patient age, and the fraction of the tumor that is immature. Treatment of benign~     mediastinal teratoma includes complete surgical resection, with results in a excellent~     long-term cure rates. Complete resection of teratomas should be the goal of treatment.~   "
208177|NCT00836108|"~     Controlling the way people with lung problems breathe during arm exercises may reduce their~     breathlessness during activities of daily living that require them to lift their arms (i.e.~     brushing their hair, putting groceries away on high shelves). The main aim of this study is~     to determine the effects of specific breathing strategies during arm exercise on dyspnoea in~     patients with chronic lung disease. Coordinating inspiration with the action of arm elevation~     will reduce dyspnoea during a rhythmic overhead arm activity~   "
208178|NCT00836095|"~     Laryngeal mask airway is a widely used device in routine anesthesia for airway management~     during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth~     after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal~     mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway~     Supreme is a newer version of the laryngeal mask airway.~      The research is being done to compare two variants of the laryngeal mask airway: the Proseal~     laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the~     newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned~     than the older model, the Proseal laryngeal mask airway. Both models are approved for use by~     the FDA, and are routinely used to assure the airway during general anesthesia.~   "
208179|NCT00836082|"~     To determine if PF-04457845 at doses of 0.5mg, 1mg, 4mg, and 8 mg given once daily for 14~     days will be safe and well tolerated in healthy volunteers. To determine the effect on food~     on PF-04457845 pharmacokinetics and safety following administration of single doses of 4mg~     and 8mg.~   "
208180|NCT00836069|"~     This study is a randomized, double-blind, parallel-group, multi-site, Phase 3, placebo~     controlled fixed-dose study of PD 0332334 and paroxetine in 528 outpatients with generalized~     anxiety disorder. Subjects will be randomized to the following treatments (132 subjects per~     treatment group):~      PD 0332334 225 mg BID (450 mg/day), PD 0332334 300 mg BID (600 mg/day), placebo or paroxetine~     20 mg QD (20 mg/day).~      [QD: once daily, qAM: each morning, BID: twice daily].~      The study will consist of 3 phases: an initial screening phase which must be completed 7 to~     14 days prior to randomization; an 8-week double-blind treatment phase; and a 2-week~     double-blind dose-tapering follow-up phase. After obtaining written informed consent the~     investigator will initiate washout of prior psychotropic medications. After the washout of~     prior psychotropic medications has been completed the investigator must ensure that the~     subject is no longer taking psychotropic medication for at least 14 days prior to the~     randomization visit. In addition the investigator must ensure that screening visit procedures~     (with the exception of obtaining informed consent) are completed within 14 days of the~     randomization visit.~      Potential subjects will be approached during a regularly scheduled clinic visit, upon~     referral from another physician, or in response to research advertisements. Those who call in~     will participate in a short phone pre-screen. This allows us to determine if the person fits~     the most limiting inclusion/exclusion criteria before requesting they dedicate a longer~     period of time for an in-person screen. Additionally it gives interested individuals the~     opportunity to learn more about the study and to review the consent form with family,~     friends, and other physicians prior to coming in for the screen and making a final decision~     regarding study enrollment. Once the subject has given informed consent, the screening~     process for the study will commence.~      Subjects who fulfill entry criteria will be randomized to receive ONE of the following 4~     treatments in a double-blind fashion: PD 0332334 225 mg BID, PD 0332334 300 mg BID, placebo,~     and paroxetine 20 mg QAM. PD 0332334 will be titrated up in the PD 0332334 225 mg BID and PD~     0332334 300 mg BID treatment groups. The titration of PD 0332334 will be from 125 mg in the~     beginning of the study. In addition the PD 0332334 225 mg BID and PD 0332334 300 mg BID~     treatment groups will be titrated down at the end of the study. The 20 mg daily dose of~     paroxetine used in this study is based on the approved label for the use of paroxetine in~     patients with GAD. Doses were selected for this Phase 3 study based on safety and efficacy~     information known about PD 0332334 and pregabalin (PGB), an α2δ ligand approved for the~     treatment of GAD in Europe~      The subjects enrolled will be men and women ages 18 to 65 who meet DSM-IV criteria for~     generalized anxiety disorder with a preponderance of anxious symptoms over depressive~     symptoms.~      De-identified blood samples will be collected from study subjects at Screening (Visit 1)~     according to the standard Molecular Profiling supplement to the protocol. Participation in~     this component is optional for study subjects. Samples may be utilized in the future to~     investigate GAD (generalized anxiety disorder) genetics, expression metabonomic and protein~     biomarker profiles, drug-response, or other genetic or biomarker questions. [Metabonomics:~     The study of metabolic responses to drugs, environmental changes and diseases. Metabonomics~     is an extension of genomics (concerned with DNA) and proteomics (concerned with proteins). ]~      Additionally, partners of male participants who become pregnant during the course of the~     study, will be requested to participate in order for the sponsor to collect safety~     information and understand the effects, if any, that PD 0332334 may have on her pregnancy or~     the fetus. Details of the this sub-study are described in the separate 'pregnant partner'~     consent form. Pregnant partners will be be asked to sign a separate HIPAA and consent form in~     order to participate.~      The investigators have recently received notification of an SAE (Serious adverse event) at~     another site that has already begun recruitment for this study. The MediWatch report for that~     SAE is included as a Supporting document on WEBRIDGE. Additionally, a protocol change~     clarifying the procedures to collect lab information to calculate the estimate Creatinin~     CVlearance (CLer) has been submitted. This document has been added as a supporting document~     on WEBRIDGE.~   "
208181|NCT00836056|"~     The objective of this study is to compare the rate and extent of absorption of clindamycin~     300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule~     under fasting conditions.~   "
208182|NCT00836043|"~     This study will collect data on safety, effectiveness and patient acceptance of MabCampath~     treatment under daily life conditions.~   "
208183|NCT00836030|"~     This study is conducted in Asia. The aim of this observational study is to evaluate current~     status of diabetes management, control and complications in diabetic subjects in Asia.~   "
208184|NCT00836017|"~     This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in~     treating Cervical Dystonia.~   "
208185|NCT00836004|"~     The objective of this study is to compare the rate and extent of absorption of clindamycin~     300 mg capsules (test) versus Cleocin HCl (reference, administered as 1 x 300 mg capsule~     under fed conditions.~   "
208186|NCT00835991|"~     The objective of this study is to compare the rate and extent of absorption of~     Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference)~     administered as 1 x 5 mg/500 mg film-coated tablet under fed conditions.~   "
208187|NCT00835978|"~     Axitinib dose titration (giving a higher dose of the drug above its standard starting dose)~     among certain patients may improve the response to treatment.~   "
208188|NCT00835965|"~     The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone~     with respect to the proportion of patients with a complete response (no vomiting and no use~     of rescue therapy) during 24 hours after the placement of last suture/staple.~   "
208190|NCT00835939|"~     The purpose of this study is to determine whether sclerotherapy using a 25% dextrose and 1%~     lidocaine solution is an efficacious treatment for patients with chronic Achilles~     tendinopathy who have failed a home based, heavy load eccentric training program.~   "
208191|NCT00835926|"~     To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation~     of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and~     subjects aged ≥ 60 years.~      To describe the immune response at 21 days following injection of the 2003-2004 formulation~     of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and~     subjects aged ≥ 60 years.~   "
208192|NCT00835913|"~     Severe sepsis and septic shock are causes of admission in intensive care units.Modification~     of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are~     reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to~     intensive care units.~   "
208193|NCT00835900|"~     The purpose of this study is to explore the use of an prolonged alternative dosing schedule~     using varenicline for smoking cessation leading to greater quit rates and higher rates of~     continuous abstinence.~   "
208194|NCT00835887|"~     In this study, the acute and long-term effects of flavanols on vascular function in patients~     with ESRD will be investigated.~   "
208195|NCT00835874|"~     We hypothesize that supplementing maternal diet with probiotics will decrease the incidence~     of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed~     breastmilk.~   "
208196|NCT00835861|"~     Many women come into pregnancy with diabetes that is controlled with either Metformin or diet~     control; however, the current standard of care for the treatment of preexisting diabetes in~     pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic~     control, and has been used in pregnancy for other indications without adverse maternal or~     fetal outcomes. What remains unproven is the ability of Metformin to adequately control~     glucose in women during pregnancy.~      Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by~     either diet or an oral agent and women who are found to have an abnormal glucose challenge~     test at less than 20 weeks to either standard treatment with weight based Regular and neutral~     protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide~     glycemic control that is equivalent to insulin in these women.~   "
208197|NCT00835848|"~     Both pre- and postconditioning seem to protect cardiomyocytes during reperfusion therapy.~     Investigations both ex vivo and in vivo suggest that a gut derived hormone,~     Glucagon-Like-Peptide-1 (GLP-1), is able to reduce reperfusioninjury after myocardial~     ischemia. Results from our own laboratory have shown a marked reduction in infarct size when~     rat hearts in a Langendorf preparation were exposed to the GLP-1 analogue, exendin-4. The~     investigators want to investigate to what extent this effect can be translated to humans in~     the setting of acute STEMI treated with primary PCI when evalutaed by cardiac magnetic~     resonance imaging.~   "
208198|NCT00835835|"~     This study is being done to test the possible benefits of gait-specific training using~     body-weight supported, Lokomat assisted, treadmill training in people with Multiple~     Sclerosis.~   "
208199|NCT00835822|"~     The purpose of this study is to assess the therapeutic efficacy and safety of Venocur~     Triplex®, administered BID for 60 days in patients with Chronic Venous Insufficiency rated~     between CEAP 2 and 4, in comparison to a Placebo group.~   "
208200|NCT00835809|"~     Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in~     pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic~     care of severe acute respiratory insufficiency remains to clear.~      We propose to determine the more relevant marker combination in this case.~   "
208201|NCT00835796|"~     The objective of this study is to compare the relative bioavailability of finasteride 5 mg~     tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg~     tablets (Merck) in healthy, adult, non-smoking, male subjects under non-fasting conditions.~   "
208202|NCT00835783|"~     The overall aim is to validate the current use of FDG PET/CT for the diagnosis of infection~     and inflammation and examine the usefulness of PET/CT applying also other tracers.~      The results should allow us to confirm our primary hypothesis: FDG-PET/CT is better than~     established methods to confirm or exclude the diagnosis of infection/inflammation.~   "
208203|NCT00835770|"~     The primary objective of this study is to evaluate the long-term safety profile of BG00012~     (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term~     efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further~     the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic~     resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301~     (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on~     health economics assessments and the visual function test.~   "
208204|NCT00835757|"~     This study aims to validate magnetic resonance imaging and diffusion tensor imaging (MRI/~     DTI) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in~     diabetic peripheral neuropathy.~   "
208205|NCT00835744|"~     The purpose of the present study is to analyse prospectively if highly purified hMG compared~     with increased dose of clomiphene citrate has different outcomes in folliculogenesis in~     ovulation induction cycles.~   "
208206|NCT00835731|"~     The purpose of this study is to compare the dilatory effect of 400 mcg of buccally~     administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation~     and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.~   "
208207|NCT00835718|"~     A study in patients with alcohol dependence to see if MK0594 is safe and effective in~     maintaining absence of heavy drinking over a 12-week treatment period.~   "
208208|NCT00835705|"~     The objective of this study is to compare the rate and extent of absorption of~     amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin®~     (reference) administered as 1 x 400 mg-57 mg chewable tablet under fasting conditions.~   "
208209|NCT00835692|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 500~     mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1~     x 500 mg tablet) in healthy adult subjects under fasting conditions.~   "
208210|NCT00835679|"~     This phase 0 trial is studying whether 2 weeks of cetuximab and dasatinib will change tumor~     cells in patients with colorectal cancer and liver metastases that can be removed by surgery.~     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Dasatinib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
208211|NCT00835666|"~     The objective of this study is to compare the relative bioavailability of finasteride 5 mg~     tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg~     tablets (Merck) in healthy, adult, non-smoking, male subjects under fasting conditions.~   "
208212|NCT00835653|"~     Observational study of the efficacy of median nerve blocks performed using echographic~     guidance in patients presenting with or without carpal tunnel syndrome.~   "
208213|NCT00835640|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 180~     mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.~     with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral~     dose (1 x 180 mg tablet) in healthy adult volunteers under fed conditions.~   "
208214|NCT00835627|"~     The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or~     focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES)~     or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES)~     compared to patients who receive community care / treatment as usual (TAU). The purpose of~     this study is to provide pilot testing and data to inform the future multicenter randomized~     controlled trial based on the hypothesis.~   "
208215|NCT00835614|"~     The objective of this study is to compare the relative bioavailability of cefprozil for oral~     suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension~     250 mg/5 mL (Bristol-Myers Squibb) in healthy, non-smoking adults under fasting conditions.~   "
208216|NCT00835601|"~     This is a training study in healthy volunteers to characterize gains in lower-body resistive~     strength and cardiovascular capacity with exercise on a Combined Countermeasure Device (CCD)~     we have developed for the National Space Biomedical Research Institute. The CCD is a single~     platform which contains interchangeable modules for cardiovascular stepping exercises and~     lower body resistive exercises including squats, heel raises, abductor and adductor exercises~     and knee extension and flexion. The platform has the capability to tilt, yaw and pitch, and~     to translate in three dimensions in order to challenge the neurovestibular system. The~     underlying goal of the project is to provide a compact and efficient exercise modality that~     will prevent deterioration of the cardiovascular and musculoskeletal systems, and the~     neurovestibular system, in long-duration spaceflights. The goal of the current study is~     simply to test the hypothesis that in healthy volunteers, the exercise prescription proposed~     for the device will improve strength and VO2 max. Subjects are tested for lower body~     resistive strength and V02max at baseline, then are trained for 12 weeks, and tested again at~     followup to test for a change. 36 subjects, allowing for a 20% attrition rate, allows~     sufficient power to detect 95% percent confidence intervals in the changes in the strength~     and V02max measures of roughly 10-20%. If we observe gains in these indices which are similar~     to those reported in the literature for simultaneous cardiovascular and resistive strength~     protocols, then we believe that there is sufficient evidence to test CCD in a bedrest model~     of long-duration spaceflight.~   "
208217|NCT00835588|"~     The objective of this study is to compare the relative bioavailability of pantoprazole sodium~     40 mg delayed-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and~     distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released~     tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under fasting conditions.~   "
208218|NCT00835575|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg~     Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries,~     Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally~     Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single~     oral dose (1 x 15 mg) in healthy adult subjects under fasting conditions.~   "
208219|NCT00835562|"~     Displaced four-part fractures are among the most severe injuries of the proximal humerus. The~     optimal treatment is disputed and published data are inadequate for evidence-based decision~     making.~      The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and~     non-surgical management, 2) compare the effect of primary hemiarthroplasty with both~     osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus~     impacted' and 'classical' four-part fracture patterns.~      The investigators will conduct a randomised, multi-centre, clinical trial including patients~     from ten national shoulder units within a two year period. Patients will be randomised to~     non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients~     will receive a standardised three-month rehabilitation program of supervised physiotherapy.~     Patients will be followed at least one year and will be assessed blindly according to a~     standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score,~     and Short Form-36.~   "
208220|NCT00835549|"~     The objective of this study is to compare the relative bioavailability of cefdinir for oral~     suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of~     OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects~     under non-fasting conditions.~   "
208221|NCT00835536|"~     The objective of this study is to compare the relative bioavailability of ribavirin 200 mg~     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA~     Pharmaceuticals USA) with that of COPEGUS™ 200 mg tablets (Roche) in healthy, adult,~     non-smoking, females (who are unable to become pregnant) under non-fasting conditions.~   "
208222|NCT00835523|"~     The aim of the study is to explore the concept of GnRH-agonist triggering in combination with~     elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting.~     The question asked is: Does GnRH-agonist triggering and cryopreservation work, in terms of~     efficacy and safety, when applied to a larger cohort of patients, and by a number of~     different centres with different clinical routines.~   "
214868|NCT00747175|"~     The purpose of this study is to assess safety and tolerability of AZD1656 after multiple~     repeated oral doses in patients with type 2 diabetes~   "
208223|NCT00835510|"~     To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine~     hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in~     the treatment of interdigital tinea pedis, and to show the superiority of the active~     treatments over that of the placebo (vehicle).~   "
208224|NCT00835497|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg~     Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical~     Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg~     METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500~     mg tablet) in healthy adult subjects administered under fasting conditions.~   "
208225|NCT00835484|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 300~     mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of~     OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a~     single oral dose (1 x 300mg capsule) in healthy adult subjects administered under fasting~     conditions.~   "
208226|NCT00835471|"~     The purpose of this study is to assess if the combination of erlotinib and chemotherapy~     (docetaxel in case of squamous cell NSCLC or pemetrexed in case of other histological types)~     is superior to erlotinib alone and has acceptable tolerability and safety in the 2nd line~     treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC).~   "
208227|NCT00835458|"~     Background: T-shaped tissue anchors have promise to close incisions and perforations of the~     intestines securely. The closure of perforations, gastro-gastric, or intestinal fistulas~     usually requires invasive open or laparoscopic surgery under general anesthesia and can be~     complex surgeries due to their reoperative or inflammatory nature.~      Objective: The proposed use of full thickness tissue anchors adds a new surgical aspect to~     the endoscopic treatment of fistulas and perforations by offering a robust suture like~     closure of defects. Instead of a 20 cm abdominal incision or 3 or 4 one centimeter incisions~     with the related postoperative morbidity an endoscopic technique is used which requires no~     postoperative limitation of activities.~      Methods: In this study the investigators propose to use an endoscopic technique that~     eliminates the need for open or laparoscopic surgery and provides a more robust endoscopic~     repair than is possible with traditional endoscopic tools. Patients who are scheduled to~     undergo surgery for intestinal fistulas will be screened for study eligibility. Patients who~     are scheduled to undergo complex polypectomy, or submucosal dissection will be screened for~     study eligibility and informed about all possible therapies in case of an iatrogenic~     perforation (open - laparoscopic surgery, endoscopic clipping, endoscopic closure with tissue~     anchors). A commercially available flexible endoscope will be inserted through the mouth and~     the fistula or perforation will be closed using the Tissue Approximation System (Ethicon Endo~     Surgery, Cincinnati, OH).~      The investigators will initially evaluate the potential benefit, risks and impact on the~     patient's quality of life of this modified surgical technique in 5 patients.~      Expected results: The potential advantages to the patients entered into this study result~     from the avoidance of open or laparoscopic surgery with the related risks (bleeding, injury~     of organs, post operative wound infection, hernia), shorter hospital stay, reduced~     postoperative pain, earlier return to work, and cosmetic advantage.~   "
208228|NCT00835445|"~     Background: Nasal polyps are found in about 5% of asthmatic patients.A close link exists~     between the upper and lower airways and the concept of the United Airways has emerged~     mainly from studies on allergic rhinitis and asthma. However, other upper airway diseases,~     such as chronic sinusitis and nasal polyposis may influence lower airway diseases. As for~     nasal polyposis, eosinophils are the major effector cells in asthma and have been associated~     with a worsening of this condition.~      Aim: To compare normal nasal mucosa and nasal polyp biopsies from subjects with nasal~     polyposis with or without asthma.~      Hypothesis: Nasal polyps from asthmatic subjects show a more aggressive pro-inflammatory~     pattern of cytokine expression compared to nasal polyps from non asthmatic subjects, and~     therefore contribute to the development and severity of asthma.~   "
208229|NCT00835432|"~     Prospective randomized assessment of alveolar ridge alterations after augmenting dehisced~     areas by applying principles of guided bone regeneration (GBR) subsequently to implant~     installation.~      Ossix as cross-linked and BioGide as non cross-linked degradable collagen membranes, both~     used in combination with biphasic Calcium-Phosphate (BoneCeramic) as bone substitute.~     Clinical measurements and impressions from the sites of interest are to be taken at the stage~     of augmentation and 6 months after. At six months re-entry non-standardized biopsies from~     augmented sites will be taken to determine newly grown tissue in quality and quantity.~      Due to different degradation characteristics of the two collagen membranes used as barrier,~     amount of newly formed mineralized tissue is suspected to vary in tests and controls,~     respectively.~   "
208230|NCT00835419|"~     The purpose of this study is to evaluate efficacy of P276-00 in subjects with advanced~     malignant melanoma positive for cyclin D1 expression~   "
208231|NCT00835406|"~     The objective of this study is to compare the rate and extent of absorption of alendronate~     sodium 70 mg tablets (test) versus Fosamax® 70 mg tablets (reference) administered as a~     single dose of 70 mg under fasting conditions. A review of pharmacokinetic data demonstrates~     Alendronate Sodium Tablets, 70 mg, manufactured and distributed by TEVA Pharmaceuticals USA~     are bioequivalent to Fosamax® Tablets, 70 mg, manufactured by Merck Sharp & Dohme, USA.~   "
208232|NCT00835393|"~     The Objective of this study is to compare the relative bioavailability of pantoprazole sodium~     40 mg delayed-released tablets (manufactured by TEVA Pharmaceutical Industries,Ltd. and~     distributed by TEVA Pharmaceuticals USA)with that of PROTONIX® 40mg delayed-released tablets~     (Wyeth- Ayerst) in Healthy, adult, non-smoking subjects under non- fasting conditions.~   "
208233|NCT00835380|"~     This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the~     vaccine in Chinese children between 12 and 23 months of age.~   "
208234|NCT00835367|"~     The objective of this study is to compare the rate and extent of absorption if~     amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference),administered as~     1 x 10 mg- 20 mg capsule under fed conditions.~   "
208235|NCT00835354|"~     The objective of this study is to compare the relative bioavailability of cefprozil for oral~     suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension~     250 mg/5 mL (Bristol-Myers Squibb) in healthy, non-smoking adults under non-fasting~     conditions.~   "
208236|NCT00835341|"~     Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese~     adults. Biomarker is not available for detection of malignant potential of OED till now. p16~     is an important tumor suppressor gene, which is inactivated frequently by methylation of CpG~     island in early stage of carcinogenesis. The present cohort study is to investigate whether~     p16 methylation is correlated with malignant transformation of OED.~   "
208237|NCT00835328|"~     The purpose of this study is to examine the effect of exendin-(9-39)on glucose requirements~     to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical~     therapy~   "
208238|NCT00835315|"~     Interdigital psoriasis (psoriasis alba) is atypical and rare form of psoriasis that is often~     missed as it is commonly mistaken for either dermatoses or fungal infection.In this study we~     observed and analyzed the prevalence of psoriasis interdigital of palms and soles and brought~     medical awareness to dermatologists and family doctors this rare form of psoriasis. Thus, you~     can help to avoid mistaken diagnosis and the start of correct treatment as soon as possible.~   "
208239|NCT00835302|"~     The investigators seek to develop a clinical prediction rule (CPR) to identify patients with~     a primary complaint of shoulder pain who are likely to benefit from manual therapy to the~     neck and upper back regions. Manual therapy will include mobilizations (therapist moves the~     joints in an oscillating fashion) and manipulations (therapist performs a high velocity low~     amplitude movement) The investigators hypothesize that a cluster of signs and symptoms from~     the subject history and physical examination will exist that maximize the accuracy of~     identifying patients with a primary complaint of shoulder pain likely to benefit from this~     manual therapy treatment based on a reference standard of patient-reported improvement.~      The investigators also seek to investigate the psychometric properties (how good a test is),~     including test retest reliability of a modified version of the Fear Avoidance Beliefs~     Questionnaire (FABQ) and the shortened Tampa Scale for Kinesiophobia (TSK-11) in patients~     with shoulder pain. The investigators will also look at the convergent validity (determine if~     measures that should be related are in reality related) and discriminant validity (show that~     measures that should not be related are in reality not related) of the modified FABQ and the~     TSK-11 in patients with shoulder pain.~   "
208240|NCT00835289|"~     Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death~     in the United States. Unlike the other leading causes of death, no medical therapies~     currently available improve the course of disease or affect survival in COPD. Recent~     investigations suggest that endothelial dysfunction and chronic inflammation is fundamental~     to COPD. Fish oil intake improves endothelial dysfunction and lowers levels of inflammatory~     intermediaries which may be important in the development of COPD.~      The Chronic Obstructive Pulmonary Disease Fish Oil (COD-Fish) Pilot Trial will enroll 40-45~     participants with COPD. These participants will be randomized to receive omega-3~     polyunsaturated fatty acid supplementation (PUFA) or placebo (containing corn oil). All~     participants will perform a number of noninvasive tests (including flow-mediated dilation~     (FMD) and pulmonary function testing) at study entry as well as every two months for a total~     of six months. Thirty participants who agree to it will undergo a separate procedure to~     collect cells from inside a forearm vein for analysis to be compared to 30 controls. The main~     purpose of this trial is to examine the effect of PUFA on endothelial function as measured by~     change in FMD in patients with COPD. We hypothesize that in subjects with COPD, treatment~     with PUFA will increase FMD.~   "
208241|NCT00835276|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 180~     mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.~     with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral~     dose (1 x 180 mg tablet) in healthy adult volunteers under fasting conditions.~   "
208242|NCT00835263|"~     The objective of this study is to compare the rate and extent of absorption of lamotrigine~     200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under~     fed conditions.~   "
208243|NCT00835250|"~     The purpose of the study is to determine the feasibility of cholecystectomy made by a~     transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic~     surgery).~   "
208244|NCT00835237|"~     This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK~     Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.~   "
208245|NCT00835224|"~     After a spinal cord injury the brain is no longer completely in control of the body below the~     level of injury. This affects many organs and systems in the body, we are interested in~     understanding how a spinal cord injury affects blood pressure and blood flow to the brain. We~     are going to study blood pressure while the person is seated in a wheelchair before and after~     we give the subject medications which should increase blood pressure in a laboratory setting~     and over the course of a normal day in persons with spinal cord injury.~   "
208246|NCT00835211|"~     The objective of this study was to compare the single-dose relative bioavailability of TEVA~     and Aventis Pharmaceuticals (DDAVP®) 0.2 mg desmopressin acetate tablets following a 0.8 mg~     dose under fasting conditions.~   "
208247|NCT00835198|"~     A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin~     gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe~     facial acne vulgaris~   "
208248|NCT00835185|"~     The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is~     effective in treating colorectal cancer (CRC).~   "
208249|NCT00835172|"~     The objective of this study is to compare the relative bioavailability of glimepiride 4 mg~     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA~     Pharmaceuticals USA) with that of AMARYL® tablets (Aventis) in healthy, adult, non-smoking~     subjects under non-fasting conditions.~   "
208250|NCT00835159|"~     The purpose of this study is to determine whether preoperative administration of Rivastigmine~     prevents the incidence of postoperative delirium in patients undergoing major surgery as well~     as postoperative cognitive dysfunction.~   "
208251|NCT00835146|"~     The objective of this study is to compare the relative bioavailability of ribavirin 200 mg~     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA~     Pharmaceuticals USA) with that of COPEGUS™ 200 mg tablets (Roche) in healthy, adult,~     non-smoking, females (who are unable to become pregnant) under fasting conditions.~   "
208252|NCT00835133|"~     RATIONALE: Collecting and storing samples of blood and tissue from family members of patients~     with cancer to test in the laboratory may help the study of cancer in the future.~      PURPOSE: This clinical trial is collecting blood and tissue samples from family members of~     patients with pancreatic disease, pancreatic cancer, and melanoma.~   "
208365|NCT00833664|"~     The Purpose of this study os to evaluate the relative bioavailability of the test formulation~     of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis~     Pharmaceuticals), under post-prandial conditions in healthy, non-tobacco using male and~     female adult subjects.~   "
208253|NCT00835120|"~     The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of~     bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who~     experience a partial or full response will have the option of continuing in an acute~     continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the~     safety and tolerability of pioglitazone during the acute continuation period.~   "
208254|NCT00835107|"~     This study uses polysomnographs(PSG) to investigate sleep patterns in patients with bipolar~     depression. This is a double-blind, placebo-controlled, study of ziprasidone that is added to~     patients current medications. The objective is to relate changes in slow wave and rapid eye~     movement sleep to changes in mood and overall illness severity. Participants will be randomly~     assigned to add either placebo or ziprasidone to their current treatment regimen.~     Participants make 3 to 4 study visits, over a 1 month period, at which they will be asked~     about their history, mood and sleep quality. Participants will also have three in-home~     overnight polysomnographs.~   "
208255|NCT00835094|"~     This will be an open-label, randomized, parallel-group comparison of mometasone furoate dry~     powder inhaler (MF-DPI) 400 mcg once daily administered in the morning vs. the evening for 12~     weeks in subjects with asthma.~   "
208256|NCT00835081|"~     The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg~     capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules~     (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal~     healthy non-smoking male and female subjects under fed conditions.~   "
208257|NCT00835068|"~     The primary objective of this observational study is to collect safety data on reformulated~     BeneFIX as prescribed in routine clinical practice conditions in France. The secondary~     objectives are to collect data on the clinical course of individuals treated with~     reformulated BeneFIX and on the ease of reformulated BeneFIX.~   "
208258|NCT00835055|"~     The purpose of this study is to determine whether markers on tumor tissue may be an indicator~     for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.~   "
208259|NCT00835042|"~     The objective of this study is to compare the relative bioavailability of Moexipril~     HCl/hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA~     Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy,~     adult non-smoking subjects under fasting conditions.~   "
208260|NCT00835029|"~     Background: Oral candidiasis is most frequently found among the elderly .It is accompanied~     with oral pain, irritation, burning sensation. In addition, the altered taste sensation may~     cause nutrition compromise, which may affect ones diet. Management of superficial oral~     Candida is usually achieved by treatment with clotrimazole, a fungi static drug which is~     given five times per day with instruction to slowly suck on it with out the dentures.~      Working hypothesis and aims: Management of oral candidiasis is feasible. The major~     disadvantage of the mode of action now days is the substantively of the drug in the oral~     cavity and patient compliance. A sustained release varnish which is easily applied on the~     dentures, which also release the anti fungal drug for at least a day, may overcome some of~     the pit falls of the treatment applied today.~      Based on our past experience, in developing local sustained release varnishes for dental use,~     we anticipate that we can also formulate a special anti fungal sustained release varnish~     which will fit the special and unique needs of the elderly population.~      Methods: Sustained release varnish will be developed in our laboratory. The kinetics of~     release (using HPLC) and antifungal activity (Bioassays) will be examined in vitro. The~     formulation showing the optimal results will be tested on human subjects with oral~     candidiasis. The efficacy of the varnish will be examined clinically (reduction in symptoms),~     microbiology (reduction of oral fungal), pharmaceutically (release kinetics in vivo).~      Expected results: The clinical out come of one time varnish application will be improved~     compared to the five times application of lozenges (used today). The severity of the disease~     should decrease and the healing period should be shorten drastically.~      Importance: This is a novel pharmaceutical development of a local application of a dental~     varnish designed specially to the elderly population~   "
208261|NCT00835016|"~     Aim:~      To assess the feasibility of provision of an early psychosocial stimulation programme for the~     children of depressed mothers and to determine its effect on, mothers depression , mothers'~     knowledge and practices of childrearing and on children's development.~      Hypothesis:~      Primary hypothesis:~      Mothers attending the psychosocial stimulation program will have significant improvement in~     the level of depression as compared to the mothers who are on the waiting list.~      Secondary hypothesis:~      Children of mothers having the intervention will have significantly better growth than the~     children of mothers who do not have the intervention.~      Design:~      Randomised controlled trial.~      Setting:~      An urban slum in a township in Karachi.~      Participants:~      A total of 130 randomly selected depressed mothers in the intervention group and a total of~     130 mothers in the waiting list control group.~      Interventions:~      Weekly LTP groups for the first eight sessions and two fortnightly sessions. Parenting issues~     will be discussed with the mothers and play activities will be demonstrated with the children~     using LTP and homemade materials.~      Main outcome measures:~      Mothers scores on EPDS & HAM D , Parenting stress as measured by PSI-SF and mothers'~     knowledge and practices of child rearing measured by questionnaires. Children's height,~     weight, head and arm circumference.~   "
208262|NCT00835003|"~     The caesarean section rate is rising globally. About 10% of the newborns are submitted to a~     neonatal department after planned caesarean section, primarily with respiratory disorders.~     More children are submitted if caesarean is performed earlier in pregnancy.~      Study hypothesis: More newborns are admitted after planned caesarean at 38 weeks and 3 days~     of gestation than after 39 weeks and 3 days of gestation.~      Aim of study: To compare elective caesarean section performed at 38 weeks and 3 days of~     gestation with 39 weeks and 3 days of gestation. According to this timing to determine the~     proportion of newborns admitted within 48 hours after birth.~   "
208263|NCT00834990|"~     This study will compare the relative bioavailability of 500 mg Divalproex Sodium~     Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1~     x 500 mg tablets) in healthy subjects under non-fasting conditions.~   "
208264|NCT00834977|"~     The objective of this study is to compare the rate and extent of absorption of~     amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered~     as 1 x 10 mg capsule under fasting conditions.~   "
208265|NCT00834964|"~     The objective of this study is to compare the rate and extent of absorption of venlafaxine 25~     mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fasting~     conditions.~   "
208266|NCT00834951|"~     The purpose of this study is to determine whether the application of low dose total body~     irradiation following chemo-immuntherapy in elderly patients with aggressive with~     non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy~   "
208267|NCT00834938|"~     Bariatric surgery can lead to improvement or even resolution of type 2 diabetes in about 80%~     of patients submitted to Roux-en-Y gastric bypass (RYGP). Otherwise, many patients~     experienced no resolution of their diabetes despite massive surgical-induced weight loss.~     There appears to be a variable response to surgery depending on surgical and patient factors.~     To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed~     to make a description of effects of surgical procedures on incretin, insulin production and~     sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.~   "
208268|NCT00834925|"~     This study is to show the efficacy and safety of low dose diltiazem for the treatment of~     atrial fibrillation with rapid ventricular response in emergency room. We will compare the~     standard dose of diltiazem(0.25mg/kg) with low dose diltiazem(0.1mg/kg)in atrial fibrillation~     with rapid ventricular response in ED.~   "
208269|NCT00834912|"~     The objective of this study is to compare the rate and extent of absorption of two Tramadol~     Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites,~     administered as 1 x 300 mg controlled-release tablet under fasting conditions. The effect of~     food on the to-be-marketed formulation was also assessed.~   "
208270|NCT00834899|"~     This study will evaluate the safety of eptifibatide in sickle cell patients and how well it~     works during the course of painful crises. The overall hypothesis that we seek to test is~     that increased platelet activation and the resultant inflammatory responses are important~     contributors to the problems of sickle cell disease. Sickle cell disease has been referred to~     both as a condition associated with increased risk of blood clots and increased inflammation.~     A painful crisis represents the most common cli nical problem in sickle cell disease, but the~     treatment of these crises remains inadequate.~   "
208271|NCT00834886|"~     In this study the investigators will examine the effects of melatonin and light therapy on~     delayed sleep phase syndrome in adolescents 16 up to 20 years old. 60 subjects will be~     randomized into four different groups; melatonin + light therapy (N=15), melatonin + placebo~     light (N=15), placebo + light therapy (N=15) and placebo + placebo light. This is a~     double-blinded treatment and the participants will receive this treatment for 2 weeks. Then~     they will be re-randomized into two groups; full treatment with light therapy + melatonin~     (N=30) and no treatment (N=30) for 3 months unblinded. The investigators will test the~     subjects pre-treatment, post 2 week treatment and after 3 months.~   "
208272|NCT00834873|"~     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the~     relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and~     equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham~     Pharmaceuticals) in a test population of 24 adult individuals under fed conditions.~   "
208273|NCT00834860|"~     Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the~     treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The~     efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its~     impact on the outcome in chronic hepatitis C patients concomitant with hepatocellular~     carcinoma deserve to be elucidated.~      The purposes of this study are:~        1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin~          combination therapy in chronic hepatitis C patients concomitant with hepatocellular~          carcinoma.~        2. To investigate the role of baseline and on-treatment factors on the response to~          pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C~          patients concomitant with hepatocellular carcinoma.~   "
208274|NCT00834847|"~     The objective of this study is to compare the relative bioavailability of pravastatin 40 mg~     tablets with that of Pravachol 40 mg tablets in healthy adult male subjects under non-fasting~     conditions. A second objective is to compare the difference in plasma levels after dosing the~     test formulation with and without food.~   "
208275|NCT00834834|"~     This study will compare the effectiveness of two treatments, dialectical behavior therapy~     versus fluoxetine with clinical management, for reducing the risk of self-injury and suicidal~     behavior in people with borderline personality disorder.~   "
208276|NCT00834821|"~     This study will test the effectiveness of a new behavioral treatment, called the Child Life~     and Attention Skills Program, for children with attention deficit hyperactivity disorder,~     inattentive type.~   "
208277|NCT00834808|"~     The purposes of this study were:~        -  To evaluate the plasma pharmacokinetic profile of tramadol and its principal metabolite,~          the O-desmethyltramadol, after a single oral administration of 100, 200 and 300 mg of~          tramadol as the Labopharm extended-release formulation prepared with Contramid.~        -  To assess the dose linearity of tramadol and its principal metabolite, the~          O-desmethyltramadol, between 100 mg and 300 mg following a single dose administration of~          the Labopharm extended-release formulation prepared with Contramid under fasting~          conditions in young healthy volunteers.~   "
208278|NCT00834795|"~     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the~     relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and~     equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham~     Pharmaceuticals) in a test population of 36 adult individuals under fasting conditions.~   "
208279|NCT00834782|"~     To compare intraocular pressure (IOP) measured by the Reichert Ocular Response Analyzer~     (ORA), Pascal dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT) in~     eyes after Penetrating Keratoplasty (KPL)~   "
208280|NCT00834769|"~     Investigation of chronic pain frequency after thoracotomy for lung cancer. Risk factors for~     development of chronic pain are investigated. Questionnaire survey.~   "
208281|NCT00834756|"~     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the~     relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an~     equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in~     a test population of 36 adult subjects under fasting conditions.~   "
208282|NCT00834743|"~     The objective of this study is to compare the rate and extent of absorption of metformin from~     a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg~     Tablets under fasting conditions.~   "
216109|NCT00730795|"~     This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals'~     candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.~   "
208283|NCT00834730|"~     -  Ketamine provides effective and relatively safe sedation analgesia for primary closure~          of lacerated pediatric patients~        -  However, deep sedation and adverse effects suggest the opportunity to develop~          alternative strategies~        -  We compared the efficacy and adverse effects of ketamine to those of N2O gas for~          analgesia and anxiolysis during primary repair of lacerated pediatric patients~   "
208284|NCT00834717|"~     The objective of this study is to evaluate the comparative bioavailability between~     granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets~     (Roche, USA), after a single-dose in health subjects under fasting conditions.~   "
208285|NCT00834704|"~     Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.~   "
208286|NCT00834691|"~     Anemia is frequent in patients with heart failure. Few studies have clearly addressed the~     causes of anemia in patients with HF. The purpose of this study is to evaluate differences in~     blood concentrations of various substances related to inflammation, oxidative stress, renal~     function and other processes between individuals with 1) heart failure and anemia, 2) heart~     failure without anemia and 3) patients with kidney disease without systolic heart failure.~     This study will help to better understand the reasons why some people with heart failure have~     anemia.~   "
208287|NCT00834678|"~     RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. Giving bendamustine together with erlotinib~     may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving~     bendamustine together with erlotinib in treating patients with stage IIIB, stage IIIC, or~     stage IV breast cancer.~   "
208288|NCT00834665|"~     The purpose of this study is:~        1. To evaluate the safety of activated T cell infusions and immunization with hTERT~          multi-peptide vaccine in the post-transplant setting and whether the combination can~          delay hematopoietic recovery or induce other autoimmune events.~        2. To determine whether the strategy of infusing vaccine-primed T-cells early after~          transplant in conjunction with post-transplant boosters leads to the induction of~          cellular immune responses to hTERT.~   "
208289|NCT00834652|"~     This study will determine whether the drug metformin improves the effects of traditional~     antidepressant medications in people who are overweight.~   "
208290|NCT00834639|"~     This study will compare the relative bioavailability of 500 mg Divalproex Sodium~     Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1~     x 500 mg tablets)in healthy subjects under fasting conditions.~   "
208291|NCT00834626|"~     Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated~     Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy~     (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic~     control in Type 2 Diabetes patients.~   "
208292|NCT00834613|"~     The objective of this study is to compare the rate and extent of absorption of metformin from~     a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg~     Tablets under fed conditions.~   "
208293|NCT00834600|"~     The purpose of this research study is to determine whether a simple blood test measuring a~     hormone called renin can better determine which first drug would be most effective in~     controlling blood pressure, in comparison with the more traditional approach recommended by~     JNC7 (Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High~     Blood Pressure).~   "
208294|NCT00834587|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg~     Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical~     Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg~     METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500~     mg tablet) in healthy adult subjects administered under non-fasting conditions.~   "
208295|NCT00834574|"~     The objective of this study is to compare the relative bioavailability of cefdinir for oral~     suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of~     OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects~     under fasting conditions.~   "
208296|NCT00834561|"~     This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine~     (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.~   "
208297|NCT00834548|"~     To compare to different approaches in whole-body magnetic resonance angiography of patients~     suffering peripheral arterial disease.~      Our hypothesis is that use of a new protocol improves the diagnostic quality of the WB-MRA~     procedure.~   "
208298|NCT00834535|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 300~     mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of~     OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a~     single oral dose (1 x 300mg capsule) in healthy adult subjects administered under non-fasting~     conditions.~   "
208299|NCT00834522|"~     The objective of this study is to evaluate the comparative bioavailability between~     granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets~     (Roche, USA), after a single-dose in health subjects under fed conditions.~   "
208300|NCT00834509|"~     The purpose of the study is to:~        -  recruit subjects with untreated sleep apnea; assess overnight changes in their blood and~          urine chemicals~        -  review the overnight changes in blood and urine chemicals after they have been treated~          for sleep apnea~        -  assess the overnight changes in blood and urine chemicals in healthy individuals with no~          sleep problems~        -  compare the amount of fat in the belly using a Magnetic Resonance Imaging (MRI) scanner~          on all subjects~   "
208301|NCT00834496|"~     Sirolimus can be safely switched as early as 90 days after liver transplantation with~     excellent tolerability and amelioration of the calcineurin inhibitor toxicity that initiated~     the switch.~   "
208519|NCT00831623|"~     The purpose of this study is to determine hypofractionated conformal proton beam radiation~     therapy of prostate cancer can achieve similar treatment benefits as our current~     institutional standard with conventional fractionation.~   "
208302|NCT00834483|"~     Barbed sutures offer several potential advantages in layered wound closure of hip and knee~     replacement surgeries. It use is gaining increased acceptance across many of the other~     surgical disciplines at this time. The purpose of this study is to evaluate the use of Quill~     as part of our layered closure compared to using our traditional sutures. The study timeline~     begins at the time of the surgical procedure and continues through the routine follow-up of~     total joint replacements at 2, 6, and 12 weeks, and will conclude at the six month~     post-operative office visit.~      Primary Objectives:~        -  To evaluate the safety and efficacy of wound closure in primary hip and knee~          replacements using a bidirectional barbed suture (knotless) compared to a traditional~          layered (vicryl) wound closure.~      Secondary Objectives:~        -  Establish the all around (intra-operative and post-operative) cost-savings potential in~          using a knotless wound closure compared to that of a layered vicryl closure (our~          standard suture protocol).~        -  Assess the overall cosmesis of the wound/scar as well as perceived presence of~          subcutaneous surgical knots, when using the knotless wound closure versus our~          traditional layered suture closure.~   "
208303|NCT00834470|"~     -  Ketamine seems an obvious choice in the setting of an emergency department~        -  Ketamine leads to increased production of salivary and tracheal secretions~        -  Antisialagogues(atropine)therefore have been recommended as a routine adjunct~        -  We compare atropine with placebo as an adjunct to ketamine sedation in children~          undergoing primary closure of lacerated wound~   "
208304|NCT00834457|"~     Open-label study of a regimen of antiretrovirals for the treatment of AIDS-KS. This study~     will be conducted at a single site, the Parirenyatwa Hospital KS Clinic.~      Step 1 was conducted to determine the extent of clinical resolution of AIDS-KS disease in~     response to treatment with antiretroviral therapy and to investigate whether clinical~     resolution of KS is associated with suppression of KSHV replication.~      Step 2 was developed to then evaluate the clinical, immunological, and virological effects of~     a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI)~     antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease~     inhibitor in persons with AIDS-KS and good virologic suppression an all NRTI regimen.~      Step 3 was included to evaluate the clinical, immunological, and virological effects of~     intensification with a ritonavir-boosted protease inhibitor in persons with AIDS-KS who have~     virological failure on an all NRTI regimen.~   "
208305|NCT00834444|"~     The objective of this study is to compare the relative bioavailability of famciclovir 500 mg~     tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult~     subjects under non-fasting conditions.~   "
208306|NCT00834431|"~     The objective of this study is to compare the relative bioavailability of famciclovir 500 mg~     tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult~     subjects under fasting conditions.~   "
208307|NCT00834418|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg~     Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™~     Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in~     healthy adult subjects under fasting conditions.~   "
208308|NCT00834405|"~     The objective of this study is to compare the relative bioavailability of leflunomide 20 mg~     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA~     Pharmaceuticals USA) with that of ARAVA 20 mg tablets (Aventis) in healthy, adult,~     non-smoking subjects [females (who are unable to become pregnant) and vasectomized males]~     under non-fasting conditions.~   "
208309|NCT00834392|"~     The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to~     standard medical care (Control Group) in prostate cancer survivors receiving androgen~     depletion therapy (ADT). The central hypothesis of the proposed research is that the walking~     exercise program will have a positive impact on the bone health, health-related quality of~     life, and physical function of men with prostate cancer receiving ADT.~   "
208310|NCT00834379|"~     The objective of this study is to compare the relative bioavailability of pravastatin sodium~     40 mg tablets with that of Pravachol® 40 mg tablets in healthy adult male subjects under~     fasting conditions.~   "
208311|NCT00834366|"~     To determine whether the test product, Labopharm Tramadol HCl Once-A-Day (OAD) 200 mg~     film-coated tablets, and the reference product, Labopharm Tramadol HCl OAD 200 mg uncoated~     tablets, are bioequivalent.~   "
208312|NCT00834353|"~     N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) are two drug metabolizing~     enzymes. Antituberculosis drug isoniazid is acetylated by NAT2 and forms ultimately a~     nontoxic compound which is metabolized by CYP2E1 to a toxic metabolite. Slow acetylator~     genotype of NAT2 and wild type genotype of CYP2E1 gene has been attributed to greater~     toxicity of ATT drug. Therefore this study has been designed to analyze the genetic~     polymorphism of NAT2 and CYP2E1 genes in tuberculosis patients who developed drug induced~     hepatitis upon administration of antituberculosis drug.Polymorphism study of NAT2 and CYP2E1~     gene may help in predicting the high risk group of ATT induced hepatitis.~   "
208313|NCT00834340|"~     The objective of this study is to compare the relative bioavailability of glimepiride 4 mg~     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA~     Pharmaceuticals USA) with that of AMARYL® tablets (Aventis) in healthy, adult, non-smoking~     subjects under fasting conditions.~   "
208314|NCT00834327|"~     This is a clinical trial to be conducted at multiple sites in the USA. Patients diagnosed~     with moderate to severe Restless Legs Syndrome will be randomly allocated to one of 5~     treatment arms in the study. The 5 arms include 4 arms with different doses of aplindore MR~     tablets and 1 placebo arm. The treatment will be taken once a day. The study is blinded and~     neither patients, nor the investigators, will know what treatment the patient is receiving.~     Patients will be assigned a dose and will be maintained at that dose for several weeks (2~     treatment arms include a short titration period). The entire study will take about 6 weeks.~     The study will measure how effective aplindore is in decreasing symptoms of Restless Legs~     Syndrome, and will also assess the safety and tolerability of aplindore.~   "
208315|NCT00834314|"~     The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques~     (the so called abdominal dressing versus vacuum-pack-technique) are equally effective in~     the treatment of open abdomen.~      Secondary purpose is the comparison of feasibility and economic aspects.~   "
208317|NCT00834288|"~     The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the~     test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product,~     Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®). For this purpose, the extent of~     absorption of tramadol and formation of O-desmethyltramadol (measures of systemic exposure)~     after multiple administration of 50 mg 6-hourly at 07:30, 13:30, 19:30 and 01:30 (reference~     product) and 200 mg 24-hourly at 07:30 (test product), were compared.~   "
208318|NCT00834275|"~     The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg~     capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules~     (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal~     healthy non-smoking male and female subjects under fasting conditions.~   "
208319|NCT00834262|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin~     Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.~   "
208320|NCT00834249|"~     The objective of this study is to compare the rate and extent of absorption of venlafaxine 25~     mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fed~     conditions.~   "
208321|NCT00834236|"~     No accurate, inexpensive and non-invasive test for gastric cancer screening is currently~     available. The investigators' recent study identified a1-antitrypsin and other proteins as~     potential biomarkers of gastric cancer in gastric juice. The aim of this study was to develop~     a novel non-invasive modality for detecting gastric cancer by measurement of biomarkers in~     gastric juice.~   "
208322|NCT00834223|"~     A prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical~     implantation of OPKO's glaucoma drainage device (AquashuntTM) in patients with refractory~     chronic forms of open angle glaucoma (OAG). The primary objective of this study is to~     evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after~     implantation in patients with refractory chronic forms of OAG~   "
208323|NCT00834210|"~     A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene~     cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe~     facial acne vulgaris~   "
208324|NCT00834197|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg~     Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries,~     Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally~     Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single~     oral dose (1 x 15 mg) in healthy adult subjects under non-fasting conditions.~   "
208325|NCT00834184|"~     The purpose of this study is to determine if nikkomycin Z is safe when administered at~     different dose levels for 14 days. The study will also determine blood levels and urinary~     excretion of nikkomycin Z in relation to dose administered. Healthy patients will be eligible~     to participate and will be allocated to receive nikkomycin Z (various doses) or a placebo.~   "
208326|NCT00834171|"~     Patient charts will be reviewed to evaluate the incidence of intraocular pressure spikes~     while on Loteprednol etabonate ophthalmic suspension 0.5%, Loteprednol etabonate (0.5%) and~     tobramycin (0.3%)~   "
208327|NCT00834158|"~     A primary hepatocellular carcinoma (HCC) is generally regarded as unresectable if the future~     liver remnant (FLR)≤40％ of total liver volume in patient with underlying liver disease, such~     as hepatitis B. In China, TACE is the most common treatment for these unresectable HCC.~     Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the~     resectability and surgical safety of major hepatectomies. In order to shut the arterio-portal~     shunt in the liver and control the tumor progress TACE sometimes is performed before PVE. In~     this study we design a randomized control trial to investigate the efficacy of sequential~     TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE~     alone.~   "
208328|NCT00834145|"~     Mobilization of fluid from the legs with the Normatec pump in patients with right heart~     failure, may empty the reservoir in the legs from excessive fluid, enabling fluid overload~     to collect there rather than in the liver or in other third spaces. Thus, we hypothesize that~     patients will lose weight, feel better, look better, be less prone to infections in their~     legs and to congestion of the liver.~   "
208329|NCT00834132|"~     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the~     relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an~     equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in~     a test population of 24 adult subjects under fed conditions.~   "
208330|NCT00834119|"~     This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to~     determine the effectiveness of regular intranasal steroid use in alleviating allergic~     rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine.~     Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An~     oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if~     patients fail to improve nasal symptoms.~   "
208331|NCT00834106|"~     A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP~     vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine~     type-specific genital disease among Chinese females between the ages of 20 and 45.~   "
208332|NCT00834093|"~     The purpose of this research study is to determine how effective and how safe it is to give~     an Epstein-Barr Virus (EBV) immunotherapy product to participants with nasopharyngeal~     carcinoma (NPC) associated with EBV that has come back or spread to other parts of the~     participants body. The EBV immunotherapy product will be made with white blood cells from the~     participants blood and takes about 16 weeks to create. This EBV immunotherapy product may~     stop cancer cells from growing and cause the tumors to disappear.~   "
208333|NCT00834080|"~     The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone~     (VIVITROL®) when administered over a period of 24 months to health care professionals who~     have a history of opioid dependence.~   "
208334|NCT00834067|"~     The objective of this study is to compare the relative bioavailability of moexipril HCl/~     hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals~     USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy, adult, non-smoking~     subjects under non-fasting conditions.~   "
208337|NCT00834028|"~     This project will include at least 40 patients with hepatocellular carcinoma (HCC) who will~     receive transcatheter arterial chemoembolization (TACE) as a sole method for the management.~     The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of~     vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are~     determined. All patients will be evaluated according to the TNM system for the cancer staging~     before and 3 months after each session of treatment. The vascularity of tumor, the drug and~     the dose used for embolization, and the area of infarction will be recorded. These data will~     be compared with the clinical courses of the patients to obtain the most suitable way in the~     management of these patients.~   "
208338|NCT00834015|"~     The aim of the present study is to analyse the significance of postoperative combined~     strength and aerobic training for outcome of the lumbar fusion patients compared to usual~     care (patients with isthmic or degenerative spondylolisthesis).~   "
208339|NCT00834002|"~     RATIONALE: Vaccines made from a patient's white blood cells (dendritic cells) and a specific~     leukemia antigen (Wilms tumor antigen-1) may induce an effective immune response to kill~     residual leukemic cells and/or prevent leukemia relapse.~      PURPOSE: This phase I/II trial is studying the feasibility, safety and efficacy of~     intradermal mRNA-transfected dendritic cell vaccination therapy in patients with acute~     myeloid leukemia.~   "
208340|NCT00833989|"~     The purpose of this study is to is to test increasing repeat doses of GSK249320 compared to~     placebo in patients with stroke.~   "
208341|NCT00833976|"~     This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in~     subjects who have been on an atypical (second-generation) antipsychotic medication. The~     investigators hypotheses are that patients who receive Lovaza will experience a significant~     decrease in triglycerides from baseline. Secondary hypotheses include: Patients will~     experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.~   "
208342|NCT00833963|"~     The MotHER Pregnancy Registry is a United States (U.S.)-based, prospective, observational~     cohort study in women with breast cancer who have been or are being treated with a~     trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or~     ado-trastuzumab emtansine (kadcyla) during pregnancy or within 7 months prior to conception~     (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab~     emtansine exposure).~   "
208343|NCT00833950|"~     Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or~     partial residual inhibition. This technique is based on the theory by Choy advocating that~     the induction of a sound wave with a 180 degree phase shift compared to the sound experienced~     by the patient could result in sound cancelling, likely by negation of the cortical~     perception of tinnitus.~      The aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band~     noise tinnitus patients.~   "
208344|NCT00833937|"~     The objective of this study is to compare the relative bioavailability of Zolpidem tartrate~     10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA~     Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle & Co.) in healthy, adult,~     non-smoking subjects under non-fasting conditions.~   "
208345|NCT00833924|"~     The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by~     US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular~     Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.~   "
208346|NCT00833911|"~     The purpose of this study is to collect information regarding the long-term (6 and 12 months)~     safety of Tramadol HCl Once-A-Day(OAD) 300 mg.~   "
208347|NCT00833898|"~     RATIONALE: A stress management intervention may be more effective than usual care in~     improving quality of life in caregivers of patients undergoing bone marrow transplant.~      PURPOSE: This randomized phase III trial is studying a stress management intervention for~     caregivers of patients undergoing bone marrow transplant.~   "
208348|NCT00833885|"~     With this study the investigators will try to assess the tolerability and measurability of~     the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual~     households. Households with an identified index case of influenza will be randomised into one~     of three intervention arms: 1. group, where the household will receive general information~     about transmission of influenza virus and means to prevent it (Controls); 2. group, which~     will receive surgical masks and be asked to wear them whenever they are in close contact with~     the index case or other persons of the household that became ill during the observation~     period; 3. group, which will be given and asked to wear surgical masks as well as to execute~     intensified hand hygiene.~      In addition to assessing the secondary attack rate as our primary outcome measure, the~     investigators will also try to evaluate compliance to those interventions by questionnaires.~   "
208349|NCT00833872|"~     The purpose of this first-in-man trial is to determine the safety and tolerability of~     ascending single and multiple doses of LEO 22811 in healthy male subjects as well as to~     determine the safety and tolerability of single oral doses of LEO 22811 in healthy female~     subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 22811 will~     be administered to healthy male and female subjects. In Part 2, multiple doses of LEO 22811~     will be administered to healthy male subjects.~   "
208350|NCT00833859|"~     The purpose of this study is to find out if a program of intensive chemotherapy with~     gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation~     aimed at the patient's tumor followed by more chemotherapy can increase the chances that the~     patient's pancreatic tumor can be removed completely.~   "
208381|NCT00833456|"~     The purpose of the study is to monitor the general functional changes among patients with~     schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6~     months.The primary study objective is to compare general functioning of patients with~     schizophrenia treated with Seroquel SR between baseline and the last study visit. The~     secondary study objectives are to compare general functioning of patients with schizophrenia~     treated with other atypical antipsychotic medicinal products administered once daily between~     baseline and the last study visit, monitoring of other indicators of clinical improvement,~     evaluation of patient compliance and assessment of occurrence of adverse effects~   "
208548|NCT00831207|"~     Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines~     TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy~     (HAART) failure.~   "
208351|NCT00833846|"~     Type II diabetes mellitus is rapidly becoming a global pandemic with a deleterious impact on~     cardiovascular morbidity and mortality. Understanding its pathophysiology is important for~     the development of future therapeutic interventions. Emerging evidence suggests interplay~     between mitochondrial dysfunction and the development of insulin resistance. Interestingly,~     mitochondrial dysfunction in skeletal muscle and adipose tissue are early events in the~     development of type II diabetes mellitus and are proposed to play a role in exacerbating~     insulin resistance. Although it has been demonstrated that skeletal muscle of~     insulin-resistant individuals has reduced mitochondria and mitochondrial dysfunction, whether~     this disruption of mitochondrial function is more widespread has not been explored. We~     hypothesize that this disruption of mitochondrial function is more systemic and thereby may~     contribute to the development of peripheral insulin resistance and possibly promote the~     myriad of complications associated with diabetes.~      To test these assumptions, we propose an initial proof of concept study to evaluate~     mitochondrial biology in human platelets in normal volunteers, pre-diabetic and diabetic~     subjects to assess whether mitochondrial disruption/dysfunction evolves with the progression~     to type II diabetes. In parallel, proteomic analysis will be performed to evaluate whether~     the development of insulin resistance and diabetes confers a specific modulation in the~     biological signature of human platelets with disease progression. To delineate these~     concepts, we will evaluate study subject's glucose tolerance and insulin sensitivity and draw~     blood in parallel to study their platelets. Biological readouts will include: 1) the~     quantification of the mitochondrial proteome and electron transfer chain content; 2) the~     evaluation of platelet mitochondrial respiratory function and 3) to determine the~     mitochondrial reactive oxygen species capacity and defenses. If this hypothesis is validated,~     this study will show that the mitochondrial disruption/dysfunction is a more generalized~     finding in type II diabetes. Additionally, it would propose the use of platelets as potential~     biomarkers for early detection of mitochondrial function and assessment of disease. Finally,~     this would establish a peripheral blood readout of the modification of mitochondrial function~     as a novel approach to monitor the prevention and/or reversal of insulin resistance and~     diabetes in response to therapeutic strategies.~   "
208352|NCT00833833|"~     The purpose of this study is to determine the maximum tolerated dose and effectiveness of the~     study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for~     patients with relapsed and refractory multiple myeloma~   "
208353|NCT00833820|"~     The investigators' preliminary studies demonstrated that repetitive transcranial magnetic~     stimulation (rTMS) of the brain may determine a slight slowing in the rate of disease~     progression in ALS patients (Di Lazzaro et al 2004, 2006). The aim of this study is to~     investigate whether rTMS of the motor cortex performed over a long period of time (12 months)~     in a group of patients with ALS, can have a more pronounced beneficial effect. The~     investigators will compare the disease progression in two groups of patients: the first group~     of patients will be treated with real rTMS (one week daily treatment every month) and the~     second group of patients will be treated with sham (placebo) rTMS.~   "
208354|NCT00833807|"~     The goal of this clinical research is to find the highest tolerable dose of Abraxane~     (nab-paclitaxel) when given directly to the area where the cancer is located. The safety of~     this drug will also be studied.~   "
208355|NCT00833794|"~     The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit~     of Tramadol OAD tablets versus Placebo.~   "
208356|NCT00833781|"~     The purpose of the study is to find out whether an experimental autologous dendritic cell~     vaccine is safe, well tolerated, and whether it can strengthen the immune system's response~     to HIV.~   "
208357|NCT00833768|"~     Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this~     study at approximately 50 sites within approximately 9 European countries. The purpose of~     this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a~     safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic~     CKD patients not on dialysis. Total length of participation is approximately 24 weeks.~   "
208358|NCT00833755|"~     The purpose of this study is to compare pain threshold, pain tolerance, and wind up, as~     measured by QST, before and after a single dose of ketamine infusion under two clinical~     conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid~     therapy.~   "
208359|NCT00833742|"~     Objective: Somatization of emotions accounts for excess Emergency department (ED) visits.~     Intensive Short-term Dynamic Psychotherapy (ISTDP) has methods to diagnose and manage~     somatization. We examined the feasibility, acceptability and effectiveness of ISTDP~     diagnostic and treatment methods used for patients with repeated ED presentations for~     medically unexplained physical symptoms (MUS)~   "
208360|NCT00833729|"~     To describe the response of etanercept after adalimumab has failed to produce a satisfactory~     response in moderate to severe plaque psoriasis. A total of 10 patients with moderate to~     severe psoriasis who are currently using adalimumab for at least 12 weeks but have a PGA of~     mild or worse will be transitioned to etanercept 50 mg twice weekly (BIW) for 12 wks followed~     by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.~   "
208361|NCT00833716|"~     This trial is conducted in the United States of America (USA). The aim of this clinical trial~     is to investigate how different degrees of renal impairment (mild, moderate, severe and~     end-stage renal disease) affect the pharmacokinetics of NN9535.~   "
208362|NCT00833703|"~     This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or~     infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery~     shunt.~      The primary objective was to assess the safety up to 18 months of age of the extended use of~     Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of~     age.~      The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis~     requiring intervention or any death.~   "
208363|NCT00833690|"~     The purpose of this study is to determine the safety and tolerability of inosine and its~     ability to raise urate levels in blood and cerebral spinal fluid in individuals with early~     Parkinson disease. This will determine whether it is appropriate to proceed with a larger~     study of inosine's ability to modify the rate of disability progression in PD.~   "
208364|NCT00833677|"~     The proposed project is part of a program of research to improve management of type 2~     diabetes (T2DM) through a community-academic partnership that addresses cultural factors in~     disease management. Specific aims are to: 1. Strengthen a community-academic partnership with~     the immigrant Chinese community in San Francisco to improve diabetes management; 2. Adapt and~     test a behavioral diabetes intervention, Coping Skills Training, to addresses family and~     cultural issues in immigrant Chinese patients with T2DM; and 3. Disseminate the adapted~     Coping Skills Training Program findings via the community-academic partnership to the~     immigrant Chinese American community through service programs, ethnic media, and~     professional/scientific publications. A mixed-methods CBPR approach will be used to~     interpretively adapt a behavioral intervention to be culturally appropriate, and test its~     efficacy using a repeated measures design. Two historically significant social service and~     health agencies serving immigrant Chinese in San Francisco are collaborating with this~     nurse-led interdisciplinary research team.~   "
208366|NCT00833651|"~     Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6~     months post-transplant. The influenza vaccine stimulates the immune system to builds~     protective antibodies against the flu virus.~      Previous research has shown that adult kidney transplant patients are not able to form as~     much of these protective antibodies as compared to healthy volunteers. Research has also~     suggested that different immunosuppressive medicines may have different effects on antibody~     formation. In this study, we hope to evaluate these differences in more detail.~      In recent years, increasingly effective, but also increasingly complex, immunosuppressive~     regimens have been developed, however, there has been little detailed systematic study of the~     immune changes that occur in response to vaccination with these newer immunosuppressive~     regimens.Current policies on vaccination of transplant recipients are generic and continue to~     be based on old concepts rather than on any new understanding of the effects of these newer~     therapies on the immune system.~      We hope to improve our understanding of the effects of the immunosuppressive regimens in use~     today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) on immune response to flu~     vaccine. Such knowledge will be critical to helping clinicians develop strategies for getting~     desirable immune responses while not causing rejection.~   "
208367|NCT00833638|"~     The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed~     once-a-day.~   "
208368|NCT00833625|"~     The goal of this clinical research study is to learn if the results of a positron emission~     tomography/computed tomography (PET/CT) scan done 10-14 days after beginning chemotherapy and~     radiation (chemoradiation) can predict how a patient with cancer of the esophagus will~     respond to chemoradiation. Researchers also want to learn if biomarkers (substances in the~     body associated with cancer) found in tumor tissue can predict response to chemoradiation.~   "
208369|NCT00833612|"~     Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased~     MI size.~   "
208370|NCT00833599|"~     The purpose of this study is to demonstrate the feasibility of near-infrared fluorescence~     imaging in subjects with acquired or hereditary lymphedema, in subjects with lipidema and~     other lymphovascular disorders and in normal health subjects; in order to attempt to~     correlate imaging phenotype(s) with genotype(s).~   "
208371|NCT00833586|"~     The purpose of this study is to evaluate the relative bioavailability of the test formulation~     of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis~     Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult~     subjects.~   "
208372|NCT00833573|"~     To describe GERD digestive expression according to ages: - children (from 0 to 23 months) and~     (24 months and more)- adults (from 18 to 29 years old), (from 30 to 39 years old), (from 40~     to 49 years old), (from 50 to 59 years old), (more than 60 years old)~   "
208373|NCT00833560|"~     The purpose of this study is to evaluate the safety and effectiveness of bortezomib in~     combination with a standard regimen of cyclophosphamide and dexamethasone.~   "
208374|NCT00833547|"~     This study will determine whether eszopiclone will normalize sleep patterns and restore~     sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The~     investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with~     regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography~     and sleep-dependent motor skill learning.~   "
208375|NCT00833534|"~     RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab,~     can block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. It is not yet known whether lenalidomide is more effective with or without rituximab in~     treating chronic lymphocytic leukemia or small lymphocytic lymphoma.~      PURPOSE: This phase II trial is studying how well lenalidomide works when given with or~     without rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic~     lymphoma who have undergone autologous or syngeneic stem cell transplant.~   "
208376|NCT00833521|"~     The objective of this study is to compare the relative bioavailability of Zolpidem tartrate~     10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA~     Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle & Co.) in healthy, adult,~     non-smoking subjects under fasting conditions.~   "
208377|NCT00833508|"~     This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity~     as measured by cardiopulmonary exercise testing in patients with colorectal cancer.~   "
208378|NCT00833495|"~     This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up~     to 5 sites. The purpose of this study is to determine how effective the combination of Pred~     Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the~     prevention of eye allergies. Study subjects will be randomized to one of the following:~        -  FOV1101-00 concentration 1 and Pred Mild®~        -  FOV1101-00 concentration 2 and Pred Mild®~        -  Vehicle of FOV1101-00 and Pred Forte®~        -  Vehicle of FOV1101-00 and Vehicle of FOV1101-00~   "
208379|NCT00833482|"~     This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on~     the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100~     mg once daily (QD), in healthy participants with functional CYP2C19 alleles. The study also~     reviews the effects of atazanavir/ritonavir, 300/100 mg QD, on the pharmacokinetics of~     voriconazole, 200 mg, BID in healthy participants with functional CYP2C19 alleles.~   "
208380|NCT00833469|"~     The purpose of this study is to determine whether women with postpartum major depressive~     disorder (MDD) will experience a significant decrease in depressive symptoms from baseline~     over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine~     whether women with postpartum MDD will experience a significant decrease in anxiety symptoms.~   "
208393|NCT00833300|"~     The purpose of this randomized clinical trial is to determine whether haloperidol is superior~     to olanzapine for the treatment of ICU acquired delirium. The hypothesis is that haloperidol~     is in fact superior to olanzapine in treating ICU acquired delirium and sustaining delirium~     free time.~   "
208589|NCT00830674|"~     The primary objective of this study is to assess the safety and tolerability of KRN23 after a~     single intravenous (IV) and subcutaneous (SC) administration in XLH patients.~   "
208382|NCT00833443|"~     Currently there are no medications approved for the treatment of methamphetamine addiction.~     Bupropion is an antidepressant that is approved by the Food and Drug Administration (FDA) for~     the treatment of depression and for cigarette smoking cessation but is not approved by the~     FDA for the treatment of methamphetamine addiction. Preliminary research studies suggest that~     bupropion may help people receiving treatment for methamphetamine addiction to reduce or to~     stop their methamphetamine use. But results of these studies also suggest that bupropion may~     help certain groups of patients more than others, such as men versus women and light versus~     heavy methamphetamine users, although the reasons for this difference are not known. One~     possibility is that a person's genetic make up may influence whether or not they respond to~     treatment with bupropion for methamphetamine addiction.~      The purpose of the study is to determine if bupropion is can help people reduce or stop their~     methamphetamine use and to investigate whether genetic variations influence whether people~     respond to treatment with bupropion for methamphetamine addiction, which may help doctors and~     patients better decide if treatment with bupropion will be beneficial or not. To identify~     possible genetic variations that influence response to bupropion, we will perform genetic~     tests on blood or saliva specimens from participants receiving treatment with either~     bupropion or placebo (which is a pill that contains no medication) in conjunction with~     standard cognitive behavioral therapy drug counseling. We will compare methamphetamine use,~     as assessed with urine drug screens, among participants receiving bupropion versus those~     receiving placebo to determine if bupropion helps people to reduce or stop their~     methamphetamine use. We will then compare the results of the genetic tests among participants~     who respond and who do not respond to bupropion. In addition, since the amount of~     methamphetamine a person uses was associated with response to bupropion in preliminary~     studies, we will also compare the results of genetic testing among persons with heavy versus~     light methamphetamine use before entering treatment.~      Results of this study have the potential to provide insights into the biology of~     methamphetamine addiction and help increase the understanding of how bupropion works. This~     information could be useful to develop effective medications for methamphetamine addiction~     and to improve the ability of clinicians to provide treatment to patients with~     methamphetamine addiction.~   "
208383|NCT00833430|"~     Long-term follow-up of IDE patients for publication~   "
208384|NCT00833417|"~     This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the~     efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma.~     All patients received vismodegib until evidence of progression, intolerable toxicities most~     probably attributable to vismodegib, or withdrawal from the study.~   "
208385|NCT00833404|"~     This is a 12-week clinical trial investigating the effects of smoking cessation on sexual~     functioning in men. This study consists of 3 sessions and provides 8 weeks of free nicotine~     transdermal patches. It is hypothesized that men who quit smoking, compared to men who smoke~     as usual, will demonstrate improved sexual functioning, measured both physiologically~     (erectile functioning) and subjectively (self-reported sexual functioning).~   "
208386|NCT00833391|"~     The purpose of this study is to evaluate the relative drug concentrations achieved with~     different formulations of GSK1838262 in healthy volunteers.~   "
208387|NCT00833378|"~     This is a Phase I, open-label, single sequence, crossover study to be conducted in healthy~     adult subjects. There will be a screening visit, three treatment periods, and a follow-up~     visit. In Period 1, subjects will receive a single dose of eltrombopag on Day 1, and PK~     sampling will occur for 72 hours. In Period 2, subjects will receive LPV/RTV for 14 days with~     PK sampling for 12 hours. In Period 3, subjects will receive a single dose of eltrombopag~     with LPV/RTV on Day 1 only with PK sampling for 72 hours. Subjects will return for a~     follow-up visit within 10 to 14 days of the last dose of study drugs.~   "
208388|NCT00833365|"~     The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early~     vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a~     higher PDA closure rate than later use of Ibu. Early use is defined as medication given~     before the infant reaches 96 hrs old. Late use is defined as medication given when infant is~     more than 96 hrs old.~   "
208389|NCT00833352|"~     This prospective, randomized, single blind, multi-centre study will examine the effect of the~     right ventricular (RV) lead location in patients implanted with a cardiac resynchronization~     defibrillator.~        1. Purpose :~           To compare the effect of RV mid-septal (RVS) versus RV apical (RVA) lead location on~          left ventricular reverse remodeling in patients indicated for cardiac resynchronization~          therapy device (CRT-D) over a period of 6 months and to evaluate the clinical outcome of~          the RVS versus RVA pacing, over a period of 12 months.~        2. Objectives:~      The primary objective is to demonstrate that there is no difference between the two groups~     (RVA vs. RVS) in the change of left ventricular end systolic volume (LVESV), between baseline~     and 6 months.~      The secondary objectives are to evaluate the percentage of echo-responders plus additional~     clinical and safety outcomes.~      This prospective, randomized, multi-centre, single-blind with 2 parallel arms,~     non-inferiority study will be conducted in approximately 25 study centres in Europe. The~     patients will be randomized in a 1:1 ratio. A maximum of 416 patients will be enrolled in~     this study.~      All eligible patients will be followed through baseline, randomisation, pre discharge, 1, 6~     and 12 months post-implant. Enrolment is expected to be completed in 18 months. The total~     duration of the study is expected to be approximately 30 months.~   "
208390|NCT00833339|"~     The investigators propose to conduct a randomized double-blind, parallel-group,~     placebo-controlled trial of mifepristone in veterans with military-related posttraumatic~     stress disorder (PTSD). This study will examine the clinical, neuropsychological, and~     neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to~     determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning,~     or other related clinical measures. Additionally, the investigators will observe whether~     baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the~     response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity~     are associated with treatment outcome.~   "
208391|NCT00833326|"~     This is a Phase 1 study during which patients with advanced/metastatic solid tumors will~     receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor~     support). Patients will receive increasing doses of study drug in combination with docetaxel~     in order to achieve the highest dose of study drug possible that will not cause unacceptable~     side effects. Patients will be followed to see what side effects the combination causes and~     what effectiveness the combination has, if any, in treating the cancer. Approximately 30~     patients from the US will be enrolled in this study.~   "
208392|NCT00833313|"~     Atrial fibrillation is a type of irregular heartbeat that is common after having heart~     surgery. There may be many different reasons why some people get atrial fibrillation after~     their heart surgery. These reasons may include that a person is older or that he/she is~     taking certain types of medications before surgery. Genes may also be a reason. Genes contain~     the material passed from parent to child that determines the make-up of the body and mind.~     For example, some genes control the color of your hair or eyes. Some people may have genes~     that make it more likely for them to get atrial fibrillation after their heart surgery. This~     research project is being done to find out if the cells of people who develop atrial~     fibrillation after heart surgery are different from the cells in people who do not develop~     atrial fibrillation after surgery.~   "
208394|NCT00833287|"~     Patient who have major traumatic injury are at risk to develop postoperative inflammatory~     complications such as pneumonia and lung trouble called adult respiratory distress syndrome~     (ARDS). This study will draw blood from trauma patients are several time points after their~     injury to see if we can predict who is at greatest risk for developing pneumonia or ARDS~     based upon the results of these immune lab tests. We are particularly interested to see if~     this will be useful in obese patients who have a greater risk of these post trauma~     complications~   "
208395|NCT00833274|"~     Apathy, defined as a lack of motivation in behaviour, cognition and affect, is common in~     neurodegenerative diseases. Specific scales are available for the evaluation of apathy but it~     lacks objective evaluation methods.~      The aim of this study is to evaluate the changes in reaction time task according to the~     presence or absence of reward stimulation and to assess the relation between these~     performances and apathy scales.~   "
208396|NCT00833261|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together~     with radiation therapy works in treating patients with recurrent head and neck cancer.~   "
208397|NCT00833248|"~     The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in~     terms of reducing the size of the prostate volume in prostate cancer patients who were~     scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to~     receiving radiotherapy, it is recommended that patients with intermediate to high risk~     prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is~     known to reduce the size of the prostate and thereby decrease the required radiation field~     and enable a more safe and effective treatment. In this trial, participants were randomly~     selected (like flipping a coin) to receive either degarelix given alone or a standard hormone~     therapy (combination of goserelin and bicalutamide. The treatment was given for three months~     and the prostate size was measured by ultra sound at the beginning and at the end of the~     trial. The participants were required to come to the clinic for 5 or 6 visits during the~     three months.~   "
208398|NCT00833235|"~     This is a multi-center, prospective, controlled, observational study of the natural history~     of patients with dry eye disease.~   "
208399|NCT00833222|"~     The purpose of this study is to test the feasibility of measuring body composition by air~     displacement plethysmography (ADP) in rapidly growing, medically stable late gestation [32-35~     weeks post-menstrual age (PMA)] premature infants.~   "
208400|NCT00833209|"~     Medication Overuse Headache (MOH) is an illness affecting about 1,5 % of the general~     population. It is characterized by chronic headache occurring for at least 15 days a month,~     by a use of antimigraine drugs during at least 3 months for more than 10 days a month (for~     ergots, triptans, opiate derivates and combined analgesics) or for more than 15 days a month~     (for simple analgesics). The chronic headache must have occurred during the period of~     antimigraine drug abuse and the headache must have returned to its episodical pattern after~     withdrawal of antimigraine drugs. But, about 50% of the MOH patients will relapse during the~     first year following the antimigraine drugs withdrawal.~      The pathophysiology of MOH is still largely unknown, and the role of antimigraine drug abuse~     in the transformation from migraine through MOH is not fully understood.~   "
208401|NCT00833196|"~     A post marketing, international, multicenter, observational, prospective, longitudinal study.~     The purpose of the study is to describe cervical dystonia sub-types with their injection~     protocols and response to BoNT-A.~   "
208402|NCT00833183|"~     A study of safety and efficacy of topical methyaminlevulinate 80mg/g with and without~     occlusion followed by red light exposure in subjects with facial acne.~   "
208403|NCT00833170|"~     The purpose of the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry~     is to study the contemporary natural history of children <16 years of age newly diagnosed~     with inflammatory bowel disease. The project follows these children quarterly from diagnosis~     examining clinical, laboratory, and humanistic outcomes. Genetic and serologic monitoring is~     performed on the study population.~   "
208404|NCT00833157|"~     The investigators will investigate the effect of glucosamine or ibuprofen combined with 12~     weeks of muscle strength-training in patients with knee-osteoarthritis.~      The investigators would like to elucidate whether treatment with glucosamine or NSAID~     interact with the effects of exercise in osteoarthritis patients.~   "
208405|NCT00833144|"~     Patients often arrive to the Emergency Department with the chief complaint of shortness of~     breath. The cause of the shortness of breath may be due to many things, such as pneumonia,~     emphysema, a heart attack, heart failure, and others. It is often very difficult for the~     physician to determine the cause of the shortness of breath in the first two hours in the~     Emergency Department. This ambiguity makes treating the patient very difficult. Although a~     patient could benefit from treatment upon arrival, the emergent treatment of the condition~     must wait until a final diagnosis is made.~      Recently, emergency physicians have been using portable ultrasound at the patient's bedside~     to diagnose numerous conditions, including trauma, blood clots, kidney stones, etc. Recent~     research suggests that heart failure, one of the causes of shortness of breath, may be~     diagnosed within 5 minutes or less using ultrasound. Most of these studies come from the~     intensive care and cardiology. However, no research has yet been performed to determine if~     emergency physicians can effectively use ultrasound to quickly diagnose and treat heart~     failure within the first few minutes of a patient's arrival to the emergency department. The~     hypothesis of this study is to evaluate the ability of residents in emergency medicine to use~     ultrasound to diagnose patients in heart failure who presented with the chief complaint of~     shortness of breath. The final diagnosis of the patient upon discharge from the hospital will~     be compared to the preliminary diagnosis based on the portable ultrasound findings.~   "
208725|NCT00828906|"~     To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of~     target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for,~     open-angle glaucoma (OAG) or ocular hypertension (OH).~   "
208406|NCT00833131|"~     The addition of Oxaliplatin to conventionally fractionated chemoradiation (FULV or~     capecitabine) is considered as standard in unresectable rectal cancer by the panel of~     experts. The Investigators addressed the question whether short-course preoperative~     radiotherapy with consolidating chemotherapy of FOLFOX4 may increase the rate of R0 resection~     in patients with unresectable rectal cancer.~   "
208407|NCT00833118|"~     This protocol seeks to determine the efficacy and reliability of a simple maneuver, the jaw~     thrust maneuver, in addition to cricoid pressure, in improving visualization of airway~     anatomy during video laryngoscopy. Hypothesis: The grade of view of the glottis as determined~     by the modified Cormack and Lehane grading system in anesthetized patients will improve by~     performing a jaw thrust maneuver during video laryngoscopy with compared with video~     laryngoscopy alone. Similarly, the grade of the view during cricoid pressure will also~     improve with a jaw thrust maneuver.~   "
208408|NCT00833105|"~     The purpose of this study is to determine if tetraplegic individuals with incomplete spinal~     cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are~     able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new~     robotic therapy device.~      The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects~     with incomplete SCI will result in improved strength, sensation, and functional movement in~     treated limb(s).~   "
208409|NCT00833092|"~     Insomnia is not a natural part of aging but is higher in older adults because of a variety of~     factors common in later life. One of these factors may be a deficient magnesium status. This~     study will look at whether or not magnesium supplementation will improve sleep.~   "
208410|NCT00833079|"~     The primary objectives are to establish the therapeutic equivalence of tacrolimus ointment~     0.1%, manufactured by Taro Pharmaceuticals Inc. and Protopic® (tacrolimus), 0.1% topical~     ointment (Astellas Pharma US, Inc.) and to show superiority over vehicle in the treatment of~     moderate to severe atopic dermatitis.~      The secondary objectives are to compare the adverse event (AE) profiles of the two ointments~     and to investigate their systemic absorption at steady state.~   "
208411|NCT00833066|"~     The purpose of this study is to determine whether the oral administration of grass pollen~     peptides is safe and effective in the treatment of allergic rhinitis.~   "
208412|NCT00833053|"~     Participants from an ongoing observational study (P05319) who have a limited (adequate but~     less than optimal) response to infliximab will be randomized to either increase the frequency~     of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to~     their current treatment plan. While receiving infliximab study treatment(s), patients in this~     study will attend regularly scheduled office visits for various clinical tests for safety and~     effectiveness evaluations.~   "
208413|NCT00833040|"~     The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus~     placebo (sugar pill or inactive substance) in the management of breakthrough pain in cancer~     patients.~   "
208414|NCT00833027|"~     Canadian physicians to experience in real life clinical practice the efficacy and~     tolerability of adding sitagliptin to their patients who have their glycemic levels~     inadequately controlled while on metformin~   "
208415|NCT00833014|"~     The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to~     correct for mitral regurgitation intraoperatively or postoperatively, off-pump.~   "
208416|NCT00833001|"~     The purpose of this study is to evaluate the clinical performance of the PROLIFT system with~     a new lighter-weight mesh in repair of vaginal prolapse.~   "
208417|NCT00832988|"~     The primary objective of this study is to evaluate the efficacy of the automated data~     collection in the Zephyr device as compared to manual testing results for atrial and~     ventricular pacing thresholds. The secondary objectives include: to compare the in-clinic~     time needed to retrieve and document the automated device measurements for all tests to the~     additional time needed to manually measure sensing, impedance and thresholds for the same~     patient; to compare the accuracy of the automated device test results to manual testing~     results; evaluate the percentage of patients who are recommended for ACapTM Confirm~     utilization.~      The Primary Hypotheses are:~        1. The values reported from ACapTM Confirm will be within 0.125 V of the value that is~          obtained manually in clinic.~        2. The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value~          that is obtained manually in clinic.~   "
208418|NCT00832975|"~     The purpose of this observational study is to collect data regarding the population of~     patients implanted with St. Jude Medical ICD.~   "
208419|NCT00832962|"~     The study is divided in two sub-studies. The first one is an economical and performance~     comparison between two antenatal management strategies of RhD negative pregnant women: the~     first one will comprise non invasive RhD fetal typing during the second trimester of~     pregnancy (GENIFERH 1 RhD typing group), and the second will be a conventional management,~     i.e. without RHD fetal typing (GENIFERH 1 control group). The two groups will consist of 13~     maternity wards spread over French territory. The second study (GENIFERH 2) is an evaluation~     of RhD fetal typing diagnostic performance and biological feasibility in routine antenatal~     practice with development of knew technical support; it will be based on more than 3500 fetal~     genotypings performed during one year by the five laboratories participating at the two~     studies.~   "
208420|NCT00832949|"~     Inflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist~     shortages, failure of primary care providers and individuals to recognize the disease, and~     lack of awareness of the importance of early intervention, delays to rheumatologic care are~     common. Peer support models have been used for various health issues and may be one method to~     assist individuals with early IA to manage their disease and cope with stress. Qualitative~     research methods (one-on-one interviews) will seek out feedback on a peer support approach~     and explore the learning needs (informational needs, educational preferences) and opinions~     about emotional and appraisal support of individuals living with IA, from the perspectives of~     patients. The data will be analyzed and expressed themes (articulated needs and~     understandings of interviewee context) will guide the future development of a peer support~     intervention.~   "
208447|NCT00832572|"~     This study was to determine whether ranolazine was effective in the treatment of neuropathic~     pain in patients with coronary artery disease.~      Eligibility required neurological examination by the study doctor and assessment of the~     patient's pain. Eligible participants were randomized to receive blinded study medication for~     a total of 12 weeks.~   "
208421|NCT00832923|"~     The overall aim of this study will be to perform a prospective randomized clinical trial of~     an enhanced version of the IMPACT DC intervention involving short-term case management to~     facilitate PCP follow-up appointments and to provide education for parents about how to~     communicate more effectively with their children's PCPs as a means (1) to improve the rate of~     utilization of primary care services for ongoing asthma care and (2) to enhance the~     self-efficacy of parents in their interactions with their children's provider regarding the~     child's asthma care needs in 150 parents of high risk children referred within the IMPACT DC~     Asthma Clinic.~   "
208422|NCT00832910|"~     Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem,~     function and quality of life.~   "
208423|NCT00832897|"~     The purpose of this study is to postpone the corneal transplantation in keratoconus and~     promote the stiffness of the cornea across the riboflavin-UVA corneal collagen crosslinking ,~     and after, corneal ring surgery.~   "
208424|NCT00832884|"~     To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35~     years old, inclusive, who are either unable to take oral medication or require intravenous~     administration of IV Lacosamide.~   "
208425|NCT00832871|"~     The purpose of this study is to see if mifepristone prevents worsening of your cancer.~     Mifepristone is an antiprogesterone agent, a drug which blocks female hormones, that is~     commonly used for the termination of pregnancies. It has not been approved by the Food and~     Drug Administration for use in the treatment of cancer. It is unlicensed in the United States~     for your condition. However, previous work has indicated that mifepristone may be useful due~     to how it works. It is being made available for use in the United States for compassionate~     use through the Feminist Majority Foundation.~   "
208426|NCT00832845|"~     Schizophrenia is associated with significant cognitive and functional deficits. As patients~     with schizophrenia grow older, the impact of these deficits at a personal and public health~     level is likely to increase. Cognitive Behavioral and Social Skills Training (CBSST) is a~     recently developed group therapy that increased the frequency of social activities among~     middle-aged patients with schizophrenia. It also increased cognitive insight, a measure of~     the ability to reduce confidence in aberrant beliefs. To date, CBSST has not been studied in~     late-life schizophrenia. In addition, its impact on medications management, an instrumental~     function that is particularly salient in late life, and its interactions with cognition are~     largely unknown. Thus, we propose to study the efficacy of CBSST in improving social skills~     and medications management in patients with late-life schizophrenia, and to study the~     interactions between the patients' cognitive characteristics and their response to CBSST.~      Previous studies show that cognitive deficits are strong predictors of response to CBSST.~     Cognitive Remediation Treatments (CRTs) have been shown to improve cognition in patients with~     schizophrenia especially when combined with psychosocial interventions that focus on function~     such as CBSST. Thus, we also propose to assess the tolerability and impact of CRT on patients~     with late-life schizophrenia.~   "
208427|NCT00832832|"~     This research is being done to determine if closing your eyelids after you take your glaucoma~     drops makes them more effective in lowering your eye pressure, and to determine if closing~     your eyelids for 5 minutes is better than closing them for one minute~   "
208428|NCT00832819|"~     The purpose of this study is to determined the maximum tolerated dose (MTD), safety and~     tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered~     continually twice daily in combination with carboplatin and paclitaxel to patients with~     advanced or metastatic non-small cell lung cancer.~   "
208429|NCT00832806|"~     The goal of this study is to provide you with an effective treatment for reducing the~     physical and emotional stress that can occur during the early phase of being without~     cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will~     receive counseling and a supply of Champix, a medication to help suppress the symptoms of~     nicotine withdrawal.~      Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking~     cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant~     increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of~     varenicline (Champix) and IVR treatment.~   "
208430|NCT00832793|"~     Inflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist~     shortages, failure of primary care providers and individuals to recognize the disease, and~     lack of awareness of the importance of early intervention, delays to rheumatologic care are~     common. Peer support models have been used for various health issues and may be one method to~     assist individuals with early IA to manage their disease and cope with stress. Qualitative~     research methods (one-on-one interviews) will seek out feedback on a peer support approach~     and explore the learning needs (informational needs, educational preferences) and opinions~     about emotional and appraisal support of individuals living with IA, from the perspectives of~     health care providers. The data will be analyzed and expressed themes (articulated needs and~     understandings of interviewee context) will guide the future development of a peer support~     intervention~   "
208431|NCT00832780|"~     The purpose of this study is to determine the response of lung tumors to radiation therapy.~     This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a~     relatively new kind of therapy which is able to focus a large amount of radiation to a small~     area with relatively less radiation to the surrounding non-cancerous part of the organ. This~     study is being done to find out if this technique is able to control the cancer better or not~     than the standard radiation and also to study its safety.~   "
208432|NCT00832767|"~     The objectives of this trial are:~        1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic~          Cholecystectomy~        2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC~          to objectively document the scientific merit and the perceived advantages of SILS™ Port~          Laparoscopic Cholecystectomy.~   "
208478|NCT00832169|"~     The aim of this study is to get information about absorption, distribution, metabolism and~     excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.~   "
208479|NCT00832156|"~     In this study the treatment of full thickness burn wounds with cultured autologous~     keratinocytes in combination with meshed split skin autograft versus meshed split skin graft~     alone will be compared. It is expected that the application of cultured autologous~     keratinocytes in combination with a meshed split skin autograft will improve wound healing~     and scar formation.~   "
208433|NCT00832754|"~     Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT)~     depends on the accuracy and safety of RDT based treatment practices and on factors related to~     the health delivery system. We propose to study the accuracy and safety of RDT based~     diagnosis and treatment of febrile illness, health system determinants of effective use of~     RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial~     of RDT based versus clinical judgment based treatment of febrile illness on the incidence of~     malaria in <48 month old children will be conducted. Health Centres will be randomly~     allocated to RDT based treatment or clinical judgment based treatment arm and children under~     2years of age from the catchment area of each health centre will be followed for 2 years. The~     cost effectiveness of RDT based approach will be compare with the clinical judgement based~     treatment.~   "
208434|NCT00832741|"~     The purpose of this study is to investigate whether secretion of incretin hormones is intact~     and to what extent endogenous as well as exogenous GLP-1 controls postprandial glucose~     excursions in patients with type-1 diabetes mellitus.~   "
208435|NCT00832728|"~     This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF.~     Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1~     ratio to receive either standard medical therapy for FHF plus the ELAD® system, or standard~     medical therapy alone, with the latter defined as conventional therapy for FHF determined to~     be clinically appropriate by the treating physician.~   "
208436|NCT00832715|"~     The goal of this clinical research study is to learn how accurately an endobronchial~     ultrasound transbronchial needle aspiration (EBUS -TBNA) may detect mediastinal lymph node~     metastases in patients with clinical stage I and II non-small cell lung cancer (NSCLC).~   "
208437|NCT00832702|"~     This research study is designed to investigate the approaches to noninvasive detection and~     assessment of coronary vascular dysfunction in women by comparing the testing results from~     the invasive standard care diagnostic procedure Angiogram and from the additional noninvasive~     diagnostic procedure CMR Imaging. The investigators want to specifically study 375 female~     patients who have signs or symptoms suggestive of heart disease but don't have obstructive~     coronary artery disease. Two study sites (Cedars-Sinai Medical Center and University of~     Florida) are recruiting participants.~      The standard of care procedures include demographics, review of recent clinical symptoms,~     review of medications being taken, a physical exam, pre-angiogram blood collection, chest~     x-ray, ECG and heart angiogram. The research procedures for this study are the cold pressor~     testing, blood/urine collection, health questionnaire, the post-angiogram ECG and cardiac~     MRI.~      Patients will be asked to undergo heart angiogram testing to test for abnormalities in their~     heart arteries. If the heart angiogram shows that the patients do not have blockages in major~     heart arteries, then the patients will have coronary flow reserve measurement test (as part~     of the heart angiogram) to determine whether the patients have abnormally functioning of the~     small heart arteries. This test will be performed by infusing the three drugs: adenosine,~     acetylcholine and nitroglycerin. The three drugs are naturally occurring substances and have~     been used for routine heart angiograms.~      Cardiac Magnetic Resonance (CMR) imaging may help us more easily and non-invasively detect~     abnormalities in the inner layer of the heart muscle resulting from the abnormal function of~     the heart arteries. All the 375 participants will undergo baseline CMR imaging test and a~     subgroup of 200 participants will undergo a second CMR imaging test at their at least 1-year~     followup visit.~      Patients will be followed up using phone questionnaires at 6 weeks, 6 months for 5 years, and~     than annually for 20 years thereafter. Other procedures in this study include obtaining~     informed consent, review of demographics, physical examination, ECG, blood and urine tests,~     clinical symptoms, medications, questionnaires, etc. The core laboratories include Blood,~     Lipoprotein, Chemistry Core Lab, Reproductive Hormone Core Lab, Inflammatory Marker Core Lab,~     Oxidative Stress Core Lab, and Angiographic Core Lab. Additionally, GCRC at Cedars Sinai will~     process, store and ship samples as needed/required.~   "
208438|NCT00832689|"~     The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local~     control of cancer and prolong survival in patients with inoperable biliary tract cancer.~   "
208439|NCT00832676|"~     Inflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist~     shortages, failure of primary care providers and individuals to recognize the disease, and~     lack of awareness of the importance of early intervention, delays to rheumatologic care are~     common. Peer support models have been used for various health issues and may be one method to~     assist individuals with early IA to manage their disease and cope with stress. Qualitative~     research methods (focus groups) will seek out feedback on a peer support approach and explore~     the learning needs (informational needs, educational preferences) and opinions about~     emotional and appraisal support of individuals living with IA, from the perspectives of~     patients. The data will be analyzed and expressed themes (articulated needs and~     understandings of interviewee context) will guide the future development of a peer support~     intervention.~   "
208440|NCT00832663|"~     The purpose of this study is to determine the influence of non-steroidal anti-inflammatory~     drugs (NSAIDs) on muscle regeneration.~      The investigators' hypothesis is that ingestion of NSAID will delay or impair muscle~     regeneration.~   "
208441|NCT00832650|"~     To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic~     transit.~   "
208442|NCT00832637|"~     This is a single arm phase II trial of Gemcitabine and Oxaliplatin (Gem-Ox) with Erlotinib~     (Tarceva) for the treatment of hepatocellular carcinoma (HCC) and biliary tree cancer (BTC)~     patients with platelet counts 100,000/µL. The purpose of this study is to determine the tumor~     control rate following treatment with GEM-OX combined with Tarceva in patients with HCC.~     Tumor control rate is defined as the percentage of patients achieving a complete response,~     partial response, or stable disease at 24 weeks following treatment.~   "
208443|NCT00832624|"~     to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the~     safety and tolerability of Sitagliptin.~   "
208444|NCT00832611|"~     To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of~     life) in patients with COPD.~   "
208445|NCT00832598|"~     The purpose of this study is to help us understand gliomas, one type of brain tumor. This~     research protocol makes pictures of gliomas. We will take pictures of the glioma before and~     after treatment. The pictures are made with a positron emission tomography (PET) scanner. PET~     scans use radioactive markers to see cancer cells. We plan to use two different radioactive~     markers, [18F]FACBC and [18F]FLT, to see if the glioma responds to the treatment being~     recommended by the doctor. We are investigating whether one or both of these types of PET~     scans can help us to better understand gliomas and their response to treatment.~      We expect these pictures will give us information the your tumor and may help us to~     understand why the treatment that the patient is receiving is affecting the tumor the way~     that it is. We also hope to collect information about the amount of radioactivity exposure.~     We will measure radioactivity exposure to the tumor, brain and other organs.~   "
208446|NCT00832585|"~     This study will assess the safety, tolerability, and efficacy of Alefacept in patient with~     moderate to severe atopic dermatitis who could not be adequately controlled with topical~     therapies.~   "
208448|NCT00832559|"~     This study is designed to assess the safety and initial indications of efficacy resulting~     from multiple doses of CAVATAK injected directly into solid tumours of the Head and Neck that~     have been confirmed to express ICAM-1 and DAF.~      CAVATAK (Coxsackievirus A21) is a naturally occurring common cold virus that preclinical~     research indicates can preferentially infect and kill cancer cells expressing the receptors~     ICAM-1 and/or DAF. This virus is known to cause self limiting upper respiratory infections~     and has been used previously to challenge therapies against the common cold. The virus is not~     generically modified.~      The study proposes to administer CAVATAK to three cohorts each of three patients. The first~     cohort will receive a single dose, the second cohort will receive three doses, and the final~     cohort will receive six doses. There will a 48 hour interval between repeated doses.~      The primary objective of the study is to determine the safety and efficacy of CVA21 given by~     intratumoural injection in the treatment of recurrent, unresectable squamous cell carcinoma~     of the head and neck by measuring primary and field tumour status and adverse effects.~      Secondary objectives of the study are:~        1. Indirect measurements of efficacy by measuring appropriate biomarkers in serum and~          tumour biopsy samples for viral replication, induction of apoptosis and anti-tumour~          immune responses.~        2. To determine the time course of potential primary and secondary viraemia.~        3. To characterise the time course of the anti-CVA21 antibody response after administration~          of CVA21~   "
208449|NCT00832546|"~     The purpose of this study is to determine the effects of NGX426 on intradermal capsaicin~     induced pain in hyperalgesia.~   "
208450|NCT00832533|"~     1.1 To detect reproducible variations of serum 25-hydroxyvitamin D levels throughout the~     course of one year in relationship to objectively measured levels of ultraviolet exposure.~      1.2 To determine specific times within the year that would yield the most significant data~     that could be focused on in future, larger studies examining whether there are protective~     effects of serum vitamin D on the development of cutaneous melanoma~   "
208451|NCT00832520|"~     The purpose of this study is to find out if remeron, also called mirtazapine, can help you~     prevent weight loss while on treatment for your cancer. Remeron is currently used to treat~     depression and has not been approved by the Food and Drug Administration for use to treat~     weight loss.~   "
208452|NCT00832507|"~     This Phase 2, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study~     will compare the efficacy, safety, and tolerability of cicletanine hydrochloride (HCl) to~     placebo in subjects with PAH. Study drug will be administered alone, or on the background of~     stable PAH therapy. The study will consist of 3 periods: a screening period, a 12-week~     placebo-controlled treatment period, and a long-term, blinded extension period.~   "
208453|NCT00832494|"~     This study was designed to test the addition of DMXAA (now known as ASA404) to carboplatin~     and paclitaxel in patients with NSCLC.~   "
208454|NCT00832481|"~     This is a 17 week, randomized, single center, open-label, parallel-group study to compare~     glucose excursions and other efficacy and safety parameters of repaglinide thrice daily or~     metformin thrice daily in newly diagnosed type 2 diabetes subjects in China.~   "
208455|NCT00832468|"~     Ear acupressure is commonly applied to treat insomnia in Oriental clinical practice but~     lacking the evidence of the randomized controlled trial (RCT)of ear acupressure on insomnia.~     In this study, a RCT is conducted to investigate the complementary effect of ear acupressure~     on chronic insomnia in old adults.~   "
208456|NCT00832455|"~     a study to describe patient and physician satisfaction with montelukast therapy for the~     control of asthma used either as monotherapy or in combination with inhaled corticosteroids~   "
208457|NCT00832442|"~     Several large trials have shown that beta-blocker treatment reduces the risk of death and~     hospital admission in patients with symptomatic heart failure. Unfortunately, survey data~     suggests relatively poor utilisation of beta-blockers, despite ample evidence for good~     tolerability. Additionally there are several important unanswered questions, such as clinical~     efficacy for specific sub-populations (women, the elderly and patients with diabetes or other~     co-morbidities) and the effect of beta-blockers in combination with other medications.~     Previous meta-analyses, based on published tabular data, have been conducted although this~     approach has important biases and limitations.~      We plan to perform a carefully conducted systematic review of individual patient data from~     the major randomised trials of beta-blockers in heart failure. The goals of this~     collaborative project are to clarify the overall efficacy of beta-blockers and identify~     sub-groups that show particular benefit, thereby increasing the use of beta-blockers,~     reducing adverse clinical outcomes and the high costs associated with this condition.~   "
208458|NCT00832429|"~     The goal of this clinical research study is to use sentinel lymph node (SLN - the lymph nodes~     closest to the primary tumor that are believed to be at greatest risk for spread of the~     disease) mapping to find SLNs and biopsy them to see if you have metastatic disease (cancer~     that has spread) that would otherwise have not been found.~   "
208459|NCT00832416|"~     The purpose of this study is to compare the analgesic efficacy and safety of Tramadol Once a~     Day 100, 200, 300 mg and Placebo~   "
208460|NCT00832403|"~     This is a retrospective study, involving patients with atrophic rhinitis, that underwent Gore~     tex® implants in the nasal fossa.~      The Fetid Rhinitis or Atrophic Ozena is a chronic illness characterized by yellowish~     secretion in the initial phase and the other phases with fetid crusts and atrophy of the~     mucous bone covering. Diverse theories exist that try to explain the appearance of this~     pathology, such as: hereditary factors, immunological alterations, viral infection and~     nutritional lack. Currently, its etiology remains unknown. As there isn't any ideal treatment~     already established, this technique improves the options of treatment.~      All patients have improved after the procedure.~   "
208461|NCT00832390|"~     After 24 weeks of treatment evaluate the efficacy and security.~   "
208462|NCT00832377|"~     A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination~     eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug~     administration~   "
208463|NCT00832364|"~     The purpose of the study is to assess the safety and efficacy of an injectable biologic and~     U0279 as combination therapy compared to that of an injectable biologic alone for severe~     plaque-type psoriasis.~   "
208726|NCT00828893|"~     The purpose of this study is to assess the contribution of navigation systems recently~     developed to guide the punction needle.~   "
208464|NCT00832351|"~     Treatment in stroke units compared with treatment in general medical wards reduces the odds~     of being dead or disabled. Little is known about which components of acute stroke care that~     is responsible for this benefit.~      Early mobilisation is one of the features of stroke unit care. In Scandinavia, any~     intervention aimed to reduce the time to the first out of bed episode has been focused in~     order to prevent complications.~      However, therapeutic interventions for cerebral revascularisation and a more intensive unit~     approach for observation may postpone mobilisation. The aim of the present study is to~     identify whether early mobilisation (< 24 hours after admittance to hospital)reduce~     disability and mortality compared with mobilisation after 24 hours.~      The study is a prospective, randomised controlled study with blinded assessment at the end of~     follow up. Patients admitted to the Stroke Unit, Akershus University Hospital less than 24~     hours after stroke during 2009 - 2011 are screened for recruitment. Patients are randomly~     assigned to either mobilisation out of bed within 24 hours from admittance to hospital or~     mobilisation after 24 hours. Except early contra late mobilisation all patients receive~     standard stroke unit care.~      Patients with modified Rankin Scale 0 and 1, patients with a secondary intracerebral~     hemorrhage, patients receiving thrombolysis or patients requiring palliative care are~     excluded.~      All patients are assessed at admittance, discharge and 3 months poststroke. Investigations at~     admittance include standard blood sample, CT/MRI scan, EKG and ultrasound of carotid~     arteries.~      Main outcome is mortality and disability 3 months poststroke. Secondary outcome measures are~     neurological deficits (NIH), morbidity, complications, cognitive function reflected by Mini~     Mental State Examination and emotional function (Hospital Anxiety and Depression scale) .~      Results from this study may add important knowledge about how and when to start mobilisation~     of patients with acute stroke.~   "
208465|NCT00832338|"~     The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your~     breast tumor and allow you to preserve your breast or have less extensive surgery on your~     breast. Additionally, by receiving chemotherapy before surgery, the investigators will be~     able to determine if your cancer is responsive to chemotherapy.~   "
208466|NCT00832325|"~     The purpose of this study is to better understand how the illness has affected the identity~     and what needs the survivor may have. We hope that this information will help us provide~     better care to future adolescent and young adult cancer survivors.~   "
208467|NCT00832312|"~     The purpose of this study is to determine whether an intraarticular injection of Ozone into~     the knee joint is an effective therapy for pain control in patients with osteoarthritis of~     the knee.~   "
208468|NCT00832299|"~     A Phase II open- labeled, prospective study to determine the efficacy of pre-operative~     chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME)~     followed by an additional six cycles of FOLFOX 6.~      The objectives of this study are the following:~        1. The primary endpoint of this trial is pathologic complete response (response rate).~        2. Secondary endpoints will include observation of overall pathologic response rate,~          correlation of pathologic staging with pre-operative ultrasound and pelvic MRI staging,~          as well as observation of toxic side effects, patterns of disease relapse, disease-free~          survival outcomes and overall survival outcomes.~   "
208469|NCT00832286|"~     The purpose of this study is to identify the human intestinal microbiota (microbes that live~     inside and on human bodies) in healthy adults over a 6-month period and to study the effect~     of an antibiotic on the intestinal microbiota. Participants will include up to 60 healthy~     adult subjects, ages 18-45 years, from the Baltimore and University of Maryland communities.~     Study procedures will include providing multiple stool samples throughout the study.~     Participants will take a licensed antibiotic, Ciprofloxacin, for 3 days. Participants may be~     involved in study related procedures for up to 7 months.~   "
208470|NCT00832273|"~     VTI had established other clinical protocols to study the effects of ELAD® plus standard~     therapy compared with standard therapy alone in patients with acute on chronic (AOCH)~     (VTI-201, VTI-206) and fulminant hepatic failure (FHF) (VTI-202) and acute alcoholic~     hepatitis (AAH). However, liver failure (LF) patients who do not qualify for other protocols~     may benefit from ELAD use. In order to accommodate physician requests for the use of ELAD in~     LF patients who do not qualify for open Protocols, without the need to resort to individual~     Emergency Use INDs for each case, VTI has developed a Treatment Protocol with Cost Recovery~     to provide for expanded access to ELAD for those with LF. This uncontrolled Treatment~     Protocol has been designed to provide expanded access to ELAD in subjects with LF while~     assuring that sufficient data are collected to adequately monitor ELAD safety when used in~     this setting at multiple centers in the United States.~   "
208471|NCT00832260|"~     The purpose of this observational study is to collect data regarding the population of~     patients with a pacemaker implanted.~   "
208472|NCT00832247|"~     This is a phase I clinical study to evaluate feasibility, safety and kinetics of cellular~     therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver~     cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by~     the BMMC presence. All the patients have moderate liver disfunction and will be submitted to~     a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused~     through a peripheral vein. Scintigraphy will be performed 24 hours after infusion.~      Patients will be submitted to frequent clinical, laboratorial and image evaluation during a~     one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to~     check histological, cellular and molecular evolutive changes.~   "
208473|NCT00832234|"~     This is a Phase II multicenter study designed to evaluate the safety and efficacy of~     combination BDR. BDR will be administered in one 21-day treatment cycle followed by four~     35-day treatment cycles to patients with WM.~   "
208474|NCT00832221|"~     The aim of this study is to relate pharmacokinetics of two different formulations of~     quetiapine to PET measured receptor occupancy in the brains of healthy subjects.~   "
208475|NCT00832208|"~     This is a phase II/III open, comparative dose trial to find the lowest single dose of~     AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV~     negative patients. In this trial, the minimum effective dose will be determined in a~     sequential step, dose escalation design, which minimises the number of patients exposed to~     low, potentially inadequate doses and provides contemporaneous comparative data against the~     manufacturer's recommended dose schedule in this indication.~   "
208476|NCT00832195|"~     The purpose of this study is to assess whether shoes that are more controlling for movement~     of the foot and ankle, compared to shoes that are less controlling, will reduce the overall~     number and severity of injuries experienced during a 13-week running programme. Our~     hypothesis is that runners who wear more controlling footwear during the 13-week programme~     will experience less injury events.~   "
208477|NCT00832182|"~     This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate~     the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to~     the ANA/DCD/065 trial~   "
208480|NCT00832143|"~     Neonatal mortality rate in Uttar Pradesh, Northern India is 53.6 per thousand, and accounts~     for 8% of global neonatal deaths.It has been argued that prompt and appropriate care-seeking~     for sick neonates can substantially reduce neonatal mortality. This pre and post intervention~     trial was done to assess the impact of a pictorial Neonatal referral Card and one-to-one~     counseling of mothers on the qualified medical care-seeking behavior for sick neonates in~     urban Lucknow.~      The study hypothesis was that the counseling on danger signs along with neonatal referral~     card has no impact on availing services of a qualified medical practitioner by caregivers of~     sick neonates.~   "
208481|NCT00832130|"~     The objective of this study is to evaluate the clinical utility, safety and effectiveness of~     the Manual Mini System compared to standardized warm compress therapy for application of~     controlled, localized heat therapy in adult patients with chronic cystic conditions of the~     eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid~     deficiency dry eye, and chalazia.~   "
208482|NCT00832117|"~     The purpose of this study is to determine the highest dose of ixabepilone that can be given~     safely with cisplatin without causing severe or life-threatening side effects and for some~     patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also~     be studied~   "
208483|NCT00832091|"~     The purpose of this study is to evaluate the safety, tolerability and effectiveness of~     Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers~   "
208484|NCT00832078|"~     The purpose of this study is to evaluate the safety of an intermittent catheter in comparison~     with an already existing catheter on the market. The study is a randomised, single blinded,~     cross-over study including 25 healthy males.~   "
208485|NCT00832065|"~     Obstructive Sleep Apnea Syndrome (OSAS)is a common disease and is suspected to be associated~     with sexual dysfunction. Our purpose is to sudy the effect of CPAP (Continuous Positive~     Airway Pressure) treatment on patients' sexual dysfunction by measuring testosterone levels~     before and after CPAP treatments.~   "
208486|NCT00832052|"~     Evaluate the safety and tolerability of PF-04447943 after administration of multiple doses in~     healthy elderly participants. Evaluate plasma drug levels and effects on cognition.~   "
208487|NCT00832039|"~     Severe sepsis and septic shock are diseases of infectious origin with a high risk of death.~     The purpose of this study is to determine whether the intravenous application of selenium~     (given as sodium-selenite) can reduce mortality in patients with severe sepsis or septic~     shock. Additionally, it is investigated, whether the measurement of procalcitonin - a marker~     of infection - can be used to guide anti-infectious measures in this disease.~   "
208488|NCT00832026|"~     This research is being done to examine if a nasal cannula can be used to keep the throat open~     during sleep, thereby treating sleep apnea.~      People with sleep apnea and people who snore without sleep apnea may take part in this study.~     Sleep apnea is a disorder caused by pauses in breathing due to repetitive closure of the~     throat. The most common form of treatment for sleep apnea is continuous positive airway~     pressure (CPAP) therapy. While CPAP therapy remains the simplest and most effective treatment~     for snoring and sleep apnea, patients have to wear a nasal mask throughout the night. For~     this reason, patients often have difficulty sticking to therapy.~      Participants enrolled in this study will spend 3-nights in a sleep laboratory. In all nights,~     the investigators will monitor your sleep and your breathing throughout the night. The~     investigators will apply several electrodes (sensors) to your scalp and face to monitor your~     sleep and breathing, and other sensors to your chest, abdomen, cheek, and a finger to monitor~     your breathing and oxygen level.~   "
208489|NCT00832013|"~     Advances in health care require that more children are given sedation to allow doctors to~     perform investigations or minor procedures. Sedation drugs have traditionally been given~     orally (swallowed) by children. However, oral sedation drugs have unpredictable~     characteristics, such as duration of sedation, which may result in difficulties performing~     the planned procedure.~      Anesthetic drugs are now invariably used for sedation in children. These are given through an~     IV (skinny plastic tube inserted in to a vein). Propofol (white liquid) is the anesthetic~     drug most commonly used for sedation at BC Children's Hospital for sedation. Propofol has~     several advantages, including an accurately controllable depth of sedation (how deeply~     asleep), minimal effect on the heart and circulation and control of reflexes (e,g coughing)~     during the procedure. Propofol also promotes rapid recovery with less sickness and an earlier~     return to normal functioning following the procedure.~      While propofol has many advantages it can cause respiratory depression (reduced breathing~     rate). This reduction in breathing is more common if propofol is given quickly. When your~     child is given propofol for their proposed procedure this is performed by a pediatric~     anesthesiologist who is skilled in supporting breathing should this be required. If your~     child does not participate in this study they will still receive propofol administered by the~     anesthesiologist as this is our usual practice. It would be routine to administer the~     propofol rapidly and then support breathing for a few minutes. This is very safe in the hands~     of an expert anesthesiologist but can be sometimes more risky in other settings where~     extensive monitoring and anesthesiologists are not available. This is the setting that~     propofol is used in many institutions.~      Our goal is to determine how quickly propofol can be given without reducing breathing to the~     point that help with breathing is required.~   "
208490|NCT00832000|"~     Nondystrophic myotonias (NDM) are neuromuscular disorders caused by genetic abnormalities in~     certain muscle cell membrane proteins. The proteins affect muscle contraction. Individuals~     with NDM experience limited muscle relaxation, which then can cause pain, weakness,~     incoordination, and impaired physical activity and function. Because NDM is very rare,~     information on the best way to treat people with the disorders is lacking, and there are no~     FDA-approved therapies. The purpose of this study is to determine the effectiveness of the~     medication mexiletine in treating people with NDM.~   "
208491|NCT00831987|"~     To observe and to describe the safety during Days 0 to 21 following injection of the~     2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects~     aged 18-59 years and subjects aged ≥ 60 years.~      To measure and to describe the immune response (antibodies to hemagglutinin) 21 days~     following injection of the 2004-2005 formulation of the inactivated, split-virion influenza~     vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.~   "
208492|NCT00831974|"~     This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in~     patients suffering from indolent systemic mastocytosis with handicap.~   "
208493|NCT00831961|"~     Repeated exposure to topical antibiotics may alter the normal bacteria on the eye and in the~     nose and increase rates of resistance. This study will determine whether repeated short-term~     exposure to topical antibiotic drops which are commonly prescribed after eye injections to~     reduce the chance of infection increase rates of resistant bacteria which are normally found~     on the eye and in the nose.~      We hypothesis that certain commercially available antibiotics may increase rates of bacteria~     resistance more so than others.~   "
208494|NCT00831948|"~     Mitochondrial diseases are a heterogeneous group caused by genetic defects in mitochondrial~     DNA or in nuclear genes. POLG is the most frequently involved gene in mtDNA instability~     diseases resulting in mtDNA multiple deletion and/or depletion. It encodes the DNA polymerase~     gamma (POLγ), the only known DNA polymerase found in mammalian mitochondria. Mutations in~     POLG could explain 45% of familial progressive external ophtalmoplegia associated with~     multiple mtDNA deletions. However, in more than 70%, the analysis of the genes involved in~     mtDNA instability remains unsuccessful.~      To date, these genes are screened by sequencing methods that are not able to detect~     large-scale rearrangements. In order to detect possible large-scale rearrangements, the~     investigators propose to develop a new assay based on QMPSF (Quantitative Multiplex PCR of~     Short fluorescent Fragments) able to detect exon deletions and duplications. the~     investigators propose to screen the POLG gene by QMPSF in at least twenty patients with~     either no mutation or only one mutation detected in POLG and no mutation in other genes such~     as TWINKLE and ANT1.~      This study would allow the investigators to know if large-scale rearrangements occur in the~     POLG gene and to estimate their frequency in patients with mtDNA instability. These data are~     important to know if the sequencing analysis of POLG should be completed by the screening for~     partial deletions and duplications to ensure an accurate molecular diagnosis of these~     syndromes. Moreover, this method could be extended to ANT1 and TWINKLE genes.~   "
208495|NCT00831935|"~     The purpose of this study is to test a new monitoring technology that uses the sound of a~     depressed person's speech to assess the severity of depression symptoms. The Vocal Social~     Signals Platform (VSSP) is software that analyzes the non-verbal characteristics of a~     person's speech. This study will test this software to see if it could be a useful~     measurement tool for assessing depression symptoms. Participation in this study requires~     coming to the research headquarters twice over a three-month period. The first visit is to~     determine eligibility. Throughout the study, participants will be connected to a telephone~     system five times, on which they will answer questions about their depression symptoms. After~     answering questions, their voice will be recorded using a structured speech sample that the~     participant will read out loud. The participant will also give an unstructured speech sample,~     which will involve describing a typical day or the last movie s/he saw. The voice samples~     will be analyzed and compared to the results of the depression symptom questionnaires.~   "
208496|NCT00831922|"~     The objective of this study is to evaluate the activity of 2 oral doses of AB1010 in subjects~     suffering from active RA who have shown an inadequate response to one DMARD including MTX or~     anti-TNF, after 3 months (12 weeks) of treatment.~      The safety and efficacy will be evaluated on:~      Rate of patients achieving ACR 20, 50, 70 and 90 DAS (disease activity score) after 3 months~     treatment ACRn after 3 months treatment Therapeutic maintenance of AB1010 at 3 months Quality~     of Life assessed by SF12 Health Assessment Questionnaire (HAQ) Clinical and biological safety~     Pharmacokinetic profile of AB1010~   "
208497|NCT00831909|"~     To provide accurate and reliable information regarding NSCLC clinical management across~     European countries in order to detect unmet medical needs of this disease in terms of:~     patient and hospital characteristics; diagnostic and treatment approaches: initial and~     subsequent, follow-up patterns in clinical management; outcomes: symptoms, death,~     functionality, quality of life; use of resources and burden on patients and health care~     systems.~   "
208498|NCT00831896|"~     This study is a multicenter, open-label, dose escalation, phase 1 study of TAK 701 in adult~     patients with advanced nonhematologic malignancies. This study will be the first to~     administer TAK 701 to humans. The primary purpose of this study is to determine the safety~     profile, tolerability, and pharmacokinetics profile of TAK-701.~   "
208499|NCT00831883|"~     The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction~     intervention for currently or recently incarcerated adolescents who report problematic~     substance use.~   "
208500|NCT00831870|"~     The purpose of this study is to collect and compare EndoSure and EndoSure s2 Wireless AAA~     Pressure Sensor measurements with measurements from CT scan imaging, ultrasound, and other~     tests used to measure your AAA sac size and endoleaks following AAA repair, and during~     follow-up visits with your physician. An antenna is held over the patient's abdomen to~     measure pressure inside the aneurysm sac. The reading does not cause any discomfort, and dye~     or radiation is not needed to take the pressure measurement. To qualify, the patient must~     have a previously implanted EndoSure Sensor.~   "
208501|NCT00831857|"~     The primary objective of the study is to evaluate the feasibility of 89Zr-bevacizumab PET~     imaging as a biomarker before and during treatment with sunitinib or bevacizumab plus~     interferon in patients with RCC. 89Zr-bevacizumab PET imaging will be regarded a promising~     biomarker if the target for treatment (VEGF) can be visualised and if uptake changes after~     institution of treatment.~   "
208502|NCT00831844|"~     This phase II trial is studying the side effects and how well cixutumumab works in treating~     patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as~     cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them.~   "
208503|NCT00831831|"~     OBJECTIVE: To investigate if, among women exposed to physical violence during pregnancy, does~     a targeted intervention consisting of safety planning and referral to community advocacy~     services decrease rates of adverse perinatal outcomes including antepartum hemorrhage or~     infection, low birthweight, and perinatal death.~      DESIGN: A randomized controlled trial. SETTING: Surrey Memorial Hospital and BC Women's~     Hospital in British Columbia, Canada PARTICIPANTS: Pregnant women experiencing intimate~     partner violence MAIN OUTCOME MEASURES: We are interested in perinatal outcomes such as birth~     weight and preterm labour.~      DATA ANALYSIS: Outcomes for women in each arm of the trial will be compared in an intention~     to treat analysis. Changes in risk for adverse outcomes associated with the study~     intervention will be estimated by the odds ratios calculated by the logistic regression~     model.~   "
208517|NCT00831649|"~     The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of~     natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant~     methotrexate (MTX)~   "
208518|NCT00831636|"~     This is non randomised, open label, dose finding, efficacy and safety study, enrolling~     patients with advanced (stage III and IV) ovarian cancer It will be conducted in two~     successive phases. Phase II has a two-step design~   "
208504|NCT00831818|"~     Weight retention after pregnancy contributes to increasing rates of obesity. There is~     evidence that breastfeeding is accompanied from changes in fat mobilisation and fat mass,~     nevertheless there are no data on the effects of breastfeeding on appetite-regulation. This~     study aims to investigate the direct effect of breastfeeding on the systemic levels of~     appetite-regulating hormones: ghrelin and PYY. Blood samples will be obtained at five time~     points (before, during and after breastfeeding) in ten mothers of healthy infants who~     breastfeed on demand and in ten mothers of healthy infants who do not breastfeed. All mothers~     will be fasting since 4 hours. The results will bring information on a possible direct effect~     of breastfeeding on appetite-regulatory hormones.~   "
208505|NCT00831805|"~     The main objective of the study is to assess the rate of patients with psycho-cognitive~     troubles among hospitalised elderly patients.~   "
208506|NCT00831792|"~     The goal of this clinical research study is to learn if a decrease in the levels of prostate~     specific antigen (PSA) may be linked with the status of prostate cancer that has spread to~     the bones. Researchers also want to learn how changes in your blood PSA level might affect~     the rebuilding of healthy bones while you are being treated with TKI258 for prostate cancer.~   "
208507|NCT00831779|"~     The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity~   "
208508|NCT00831766|"~     The purpose of this study is to:~        -  Test the safety of the research study drug, lenalidomide, when given with Idarubicin and~          Cytarabine~        -  See how many respond to combination treatment with lenalidomide, Idarubicin and~          Cytarabine~        -  See how long people respond to this combination therapy~        -  See how long people live after being treated with this combination of drugs~   "
208509|NCT00831753|"~     The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T~     vaccine has immunological and safety profiles that are comparable to those of the control~     vaccine that is already marketed (Infanrix®Hexa)~      Primary Objective:~      To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune~     response that is at least as good as the response following Infanrix®Hexa in terms of~     seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months)~      Secondary Objectives:~        -  To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep~          B-PRP~T and Infanrix®Hexa) one month after the third dose of the primary series.~        -  To assess the overall safety in each group one month after each dose of the primary~          series and through the entire study.~   "
208510|NCT00831740|"~     Assessing Communication Therapy in the North West (ACT NoW) is a research project which aims~     to evaluate the effectiveness, cost effectiveness and service user preferences for~     communication therapy following stroke when compared to an attention control.~   "
208511|NCT00831727|"~     The purpose of the present study is twofold. First, we will attempt to examine the role that~     emotion regulation and self-presentation play as potential moderators in the expressive~     writing paradigm. We hypothesize that expressive writing participants who demonstrate greater~     abilities to regulate their emotions at baseline will improve more on our outcome measures.~     We also hypothesize that those expressive writing participants who demonstrate higher levels~     of self-presentation at baseline will improve less on our outcome measures.~      The second aim of the study has two related objectives. First, we will attempt to investigate~     whether the expressive writing intervention can increase and enhance an individual's emotion~     regulation abilities. Related to this, we will then go on to examine whether emotion~     regulation can be looked at as a potential mechanism of action in the expressive writing~     procedure. Related to these two objectives, we hypothesize that in comparison to the control~     group, participants in the expressive writing condition will show increases in their ability~     to regulate their emotions from baseline to four week follow up. Moreover, we predict that~     greater gains in emotion regulation abilities for the expressive writing participants will be~     significantly related to greater gains in outcome measures.~   "
208512|NCT00831714|"~     The main goal is to provide additional information to the risk-benefit assessment of the~     drug.~   "
208513|NCT00831701|"~     Current therapeutic options for ureteral stones include active intervention as well as~     conservative watch and wait approaches. Endoscopic treatment of ureteral stones has a high~     success rate and reliably results in immediate stone removal However, surgical as well as~     anaesthetic risks are not negligible and serious complications are possible. For many~     patients, a conservative treatment is an appealing option. Watchful waiting, however, not~     always results in stone clearance and may be associated with recurrent renal colics.~      The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated~     prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of~     such receptors, which are predominantly located in the distal part of the ureter results in~     relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has~     been proposed to facilitate stone passage for ureteral calculi.~      Numerous clinical trials have revealed a significant improvement of the stone expulsion rate~     using the alpha-blocker tamsulosin. Most of these studies were randomised but none were~     performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this~     trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a~     randomised, double-blind, placebo-controlled setting.~   "
208514|NCT00831688|"~     The purpose of this study to date, is that no causal therapy for Meniere's disease has been~     discovered. Local overpressure treatment for Meniere's disease is a new treatment form that~     has been shown in animal and human experiments to reduce the endolymphatic hydrops, a~     condition that is generally believed to be the pathologic hallmark of Meniere's disease. This~     study analyzes the efficacy of local overpressure treatment by measuring subjective vertigo~     severity and objective audiovestibular function parameters.~   "
208515|NCT00831675|"~     To describe the safety of the 2004-2005 pediatric formulation of the inactivated,~     split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with~     the Package Insert, in children aged ≥ 6 months to < 36 months.~      To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine~     Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in~     children aged ≥ 6 months to < 36 months~   "
208516|NCT00831662|"~     The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium~     ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.~   "
208520|NCT00831610|"~     The purpose of this study is to quantify the skin sensation of the anterior abdominal wall of~     the post-bariatric patients submitted to anchor-line abdominoplasty without flap undermining.~      Additional purposes were: quantify topographically the abdominal skin sensation of the Normal~     weight, Morbid Obese and Former Morbid Obese after bariatric surgery (before and after the~     abdominoplasty - excess skin surgical removal without flap undermining -> Anchor Line~     Abdominoplasty).~   "
208521|NCT00831597|"~     A phase II trial to evaluate the efficacy and safety of combination bendamustine and~     rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is~     hypothesized that the BR combination will produce at least a 70% overall response rate.~   "
208522|NCT00831571|"~     This research study will examine how often hypersensitivity, or allergic reactions, occur in~     patients receiving the chemotherapy medication oxaliplatin. Hypersensitivity reactions can~     vary from a transient skin rash and fever to more severe symptoms such as shortness of~     breath, chest tightness, and a more severe allergic reaction that can affect blood pressure~     called anaphylaxis. We will be examining how often hypersensitivity reactions occur and how~     severe the reactions are when they occur. We will also examine whether there are factors that~     place people at risk for developing hypersensitivity reactions to oxaliplatin. In an optional~     portion to this study, we will examine whether allergy skin testing can predict whether~     someone will develop a hypersensitivity reaction.~      Participants who develop a moderate to severe allergic reaction to oxaliplatin will be~     invited to participate in an additional portion of the study examining a desensitization~     process. This part of the study will examine whether a desensitization process can prevent~     future hypersensitivity reactions to oxaliplatin in patients who previously developed~     moderate to severe hypersensitivity reactions and allow therapy with oxaliplatin to continue.~   "
208523|NCT00831545|"~     The study implies a 2 step study design. Patients are enrolled into 3 separate groups for~     melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease~     group are enrolled. If >=2 objective responses (SD, PR, or CR) out of 21 evaluable patients~     are observed, enrollment continues for other 45 patients as a whole, where response will be~     positively evaluated if >=10 patients will respond. If <2 objective responses out of 21~     evaluable patients per disease group are observed, this(ese) group(s) will no longer be~     treated with temozolomide.~   "
208524|NCT00831532|"~     1. To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic~          impairment to subjects with normal hepatic function.~        2. To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and~          subjects with normal hepatic function.~        3. To explore the pharmacokinetics of Dimebon in subjects with severely-impaired hepatic~          function.~   "
208525|NCT00831519|"~     The aim of this study is to test and compare biochemical, hematological, and inflammatory~     factors in diabetic and healthy pregnant mothers and in their newborns.~   "
208526|NCT00831506|"~     This study has been designed to confirm, in healthy subjects, the lack of a clinically~     important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial~     dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0.125 mg QD, a~     sensitive P-gp substrate recommended by FDA.~   "
208527|NCT00831493|"~     Primary Endpoint:~      To determine the maximum tolerated dose (MTD) of vorinostat + radiation therapy (RT) in~     patients with locally advanced pancreatic cancer (LAPC).~      Secondary Endpoints:~        1. To assess the efficacy of vorinostat + RT in patients with LAPC as estimated by median~          overall survival.~        2. To determine the radiological response as assessed by regular computer tomography (CT)~          and/or dynamic contrast enhanced computer tomography (DCE-CT) among patients treated~          with vorinostat and RT.~        3. To evaluate the occurrence of symptoms and correlate to disease progression and~          tolerance to treatment using the MD Anderson Symptom Inventory-Gastrointestinal Module~          (MDASI-GI) self-reporting tool.~        4. To correlate serum cytokine levels with symptoms and treatment outcomes.~   "
208528|NCT00831480|"~     The purpose of this multicenter, pilot, open-label, Phase II clinical trial is to discover if~     Everolimus(RAD001) is safe and effective in people who have advanced kidney cancer (renal~     cell carcinoma - RCC).~      Since 2002, Everolimus has been studied in more than 2500 patients with various types of~     cancer as a single agent (a drug that is used alone to treat the cancer) or in combination~     with a number of well known anticancer therapies. Various studies, in animals such as in mice~     with cancer and in humans with cancer have shown that Everolimus can slow the growth of~     cancer.~      Everolimus will be taken in pill form by mouth daily for 3-5 weeks followed by surgery to~     remove the effected kidney. After 2-4 weeks following the surgery, Everolimus will be resumed~     at the same dose.~   "
208529|NCT00831467|"~     The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone~     refractory prostate cancer~   "
208530|NCT00831454|"~     The aim of this study was to retrospectively evaluate associations between EGFR and AKT~     DNA-polymorphisms involved in transcriptional regulation and overall survival in NSCLC~     patients treated with EGFR-TKIs.~   "
208531|NCT00831441|"~     The purpose of this study is to determine if apixaban is superior to placebo for preventing~     cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a~     recent acute coronary syndrome~   "
208532|NCT00831428|"~     The Scottish National and District swimming teams will be screened for asthma and rhinitis~     using both mannitol challenge and sport-based exercise challenge.~   "
208533|NCT00831415|"~     The primary objective of this study is to evaluate the long-term safety of desvenlafaxine~     succinate sustained release tablets during 10-month open-label treatment of Japanese subjects~     with major depressive disorder (MDD).~      The secondary objective is to evaluate the long-term response of subjects receiving~     desvenlafaxine succinate sustained release tablets by clinical global evaluation, general~     well-being and absence of symptoms.~   "
208534|NCT00831402|"~     Goals of the study :~        1. To study maternal thyroid function during pregnancy with or without supplementation with~          pregnancy tablets fortified with iodine~        2. To establish reference values of thyroid function at different stages of pregnancy (3~          trimesters)~        3. To precise screening strategy of iodine deficiency in our population and suggest~          recommendation for its prevention.~   "
208535|NCT00831389|"~     The purpose of the study is to compare the glycemic control during and following aerobic~     exercise using either an open or closed-loop insulin delivery system.~   "
208536|NCT00831376|"~     The objective of this study is to compare the relative bronchoprotection (at trough)~     conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to~     moderate asthmatics. Patients will be preselected into two groups on the basis of their~     beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a~     differential effect on the bronchoprotection conferred by both formulations of salbutamol, as~     evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any~     effect can be explained by the S enantiomer in the racemic formulation.~   "
208537|NCT00831363|"~     The hypothesis for the present study was that patients receiving a minimally invasive total~     hip arthroplasty will show a faster improvement on walking ability and mobilization in the~     immediate postoperative period compared to patients with the standard Hardinge approach.~     Therefore, the main goal was to evaluate the differences in early rehabilitation of these two~     different surgical approaches by gait analysis and electromyographical examination as~     objective methods.~   "
208538|NCT00831350|"~     This is a study of subjects with retinal vein occlusion (RVO) specifically looking at the~     difference in outcomes between patients with posterior vitreous detachment (PVD) and those~     without PVD. Posterior vitreous detachment is a condition where the gel-like substance that~     occupies the space between the retina and the lens of the eye liquefies and separates from~     the retina. 20 subjects from Barnes Retina Institute will be enrolled in this study. Based on~     a pre-treatment ultrasound (a test utilizing high-frequency sound waves to look at the inside~     of the eye), high resolution OCT (a noninvasive procedure called optical coherence tomography~     to check the thickness of your retina) and clinical exam, subjects will be assigned to one of~     2 groups at baseline: Group 1 will be those with PVD and Group 2 will be those without PVD.~     Then subjects will receive monthly intravitreal (inside the eye) injections of Ranibizumab.~   "
208539|NCT00831337|"~     This study is to evaluate the role of probiotics in the treatment of portal hypertension. In~     particular the role of probiotics on gut microbiota in liver cirrhosis patients will be~     studied and compared with cytokines and other substances implicated in the pathogenesis of~     portal hypertension. The hypothesis whether probiotics may change the prognosis of patients~     with portal hypertension will be studied. The hypothesis whether probiotics may halt the~     pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome,~     spontaneous bacterial peritonitis, bleeding varices) will be reviewed.~   "
208540|NCT00831311|"~     Primary Objective:~        -  To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for~          all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one~          month after a three-dose primary series.~      Secondary Objectives:~        -  To describe in each group the immunogenicity parameters one month after the three-dose~          primary series.~        -  To describe safety profile after each vaccination in both groups.~   "
208541|NCT00831298|"~     The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and~     activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates~     to changes in activity cycles, and how sleep disturbances may affect your daytime alertness.~      This project selects patients suffering from memory problems, or voluntary to be in our~     Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire,~     and Activity Recordings~   "
208542|NCT00831285|"~     The variation in starch and fibre composition of prepared barley tortillas will have a~     significant effect on glycemic response.~   "
208543|NCT00831272|"~     The aims of the study are to test for treatment outcome differences in alcohol dependent~     subjects randomly assigned to 12 weeks of treatment with NTX (50mg/day) or placebo among~     those with one or two copies of the Asp40 allele of the mu-opioid receptor compared to those~     homozygous for the Asn40 allele. Thus, the design of the study is a 2X2 cell double-blind~     randomization to NTX or placebo stratified by genotype. To meet these aims, 150 alcohol~     dependent outpatients with one or two copies of the Asp40 variant of the mu-opioid receptor~     and 190 subjects homozygous for the Asn40 variant will be recruited across the four~     participating sites.~   "
208544|NCT00831259|"~     Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in~     patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the~     incidence of clinically silent brain infarction is unknown. We will assess the rate of~     clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE)~     in relation to the presence or not of a PFO.~   "
208545|NCT00831246|"~     This study will attempt to determine if the use of chewing gum can cause the early return of~     bowel function after gynecologic surgery.~   "
208546|NCT00831233|"~     The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower~     urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a~     standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of~     prostate cancer may be associated with LUTS and the symptoms may impact the ability to~     urinate normally and thereby the quality of life for these patients.~      Patients were randomly selected (like flipping a coin) to receive either degarelix or~     standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment~     period. During this period the relief of urinary symptoms was evaluated via a questionnaire~     filled in by patients and addressing the severity and frequency of their symptoms.~   "
208547|NCT00831220|"~     Objective: To investigate the potential role of endothelial dysfunction as a pathogenic~     mechanism of cardiovascular events in COPD. Hypothesis: endothelial function is abnormal in~     patients with COPD, particularly during exacerbations of the disease. Design: prospective and~     controlled study performed in an university hospital. Population: we compare 4 groups of~     subjects, 44 patients with stable COPD, 35 patients with acute exacerbation of COPD, 10~     smokers or former smokers with normal lung function and 10 never smokers matched by physical~     activity and BMI. Study variables: a) clinical variables: clinical information, physical~     examination, pulmonary function tests, ECG and sputum culture; b) Biological variables:~     number of Circulating Endothelial Progenitor Cells, vascular growth factors (vascular~     endothelial growht factor and erythropoietin), systemic inflammation (C-reactive protein,~     white blood cells), peripheral venous blood test (including hemogram, biochemical analysis~     with glycemia, cholesterol, LDLcol, HDLcol); and c) systemic vascular reactivity assessment.~   "
225679|NCT00604032|"~     To assess the potential of tretnoin gel 0.05% to produce phototoxic reactions, measured as~     skin reactions 24 and 48 hours after UV radiation of drug on skin.~   "
208549|NCT00831194|"~     A clinical trial that uses personal digital assistants (PDAs) to assist in examining the~     relationship between self reported stress, an objective biochemical indicator of stress~     (salivary alpha amylase) and self-reported dietary lapse among type 2 diabetic adults who are~     interested/undergoing in weight loss.~   "
208550|NCT00831181|"~     RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage~     II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated~     with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce~     distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated~     by benefits demonstrated in stage III colon cancer.~      Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and~     RT followed by total mesorectal excision (TME) and adjuvant~      PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant~     combination chemotherapy with radiation works in treating patients undergoing surgery for~     rectal cancer.~   "
208551|NCT00831168|"~     BEADI is a dissemination trial, on standards of care of premature babies. The main objective~     of BEADI is to assess whether an innovative 'active' strategy for the dissemination of~     neonatal information (evidence reviews, interactive training workshop, benchmarking and~     feedback, and ongoing support) is more likely to lead to changes in policy and practice than~     the traditional (more passive) forms of dissemination in English neonatal units.~      BEADI will focus on three areas of neonatal care for premature (22+0 to 26+6 weeks'~     gestation) babies born in England: timing of surfactant therapy, staffing for resuscitation~     at delivery, and temperature control (in line with the main Project 27/28 findings ).~     However, the approach is applicable to a wide variety of clinical policies and practice.~      The BEADI study has been granted ethical approval by MREC to use a subset of data collected~     by EPICure2 up until 31st December 2006 (pre-intervention data). For the post-intervention~     data, ethical approval has been granted for CEMACH to continue data collection against the~     three clinical areas using a subset of data items captured in the PN:E2 form, for the three~     month period between 1st January - 31st March 2007. Local research and development~     departments of each trust have also been contacted.~   "
208552|NCT00831155|"~     The purpose of this study is to test two quit smoking therapies and to study brain function~     while each therapy is being used. You will be randomly assigned (like flipping a coin) to one~     of the two groups. The first therapy is Extinction-Based therapy (EBT). If you are in this~     group, you will switch to smoking denicotinized cigarettes while wearing a 21 mg/d nicotine~     patch for one month prior to your quit date. The second therapy is a standard Nicotine~     Replacement therapy (NRT). If you are in this group, you will smoke your usual brand of~     cigarettes up to the quit date. Following the quit date, both groups will undergo standard~     nicotine replacement therapy (21 mg/d for 6 weeks; 14 mg/d for 2 weeks, 7 mg/d for 2 weeks).~      In addition to the above, we will recruit a sample of former smokers who are now regular~     users of e-cigarettes. This group [ECIG] will undergo the same screening and baseline~     assessments as the EBT and NRT groups up to the completion of fMRI1.~   "
208553|NCT00831142|"~     The long-term goal of this proposal is to provide a pre-treatment evaluation that can assist~     in the rational selection of patients to undergo appropriate and definitive therapy for~     prostate cancer. In so doing, it may be possible to further improve the numbers and~     percentage of cancer patients who receive effective therapy that will cure the disease and~     maximize their quality of life following therapy.~        -  Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging~          prostate cancer.~        -  Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate~          gland.~        -  Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.~   "
208554|NCT00831129|"~     The purpose of this research study is to examine if a combination of a cholesterol~     lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective~     in improving vascular inflammation (irritation of the vessels that transport your blood) and~     other cardiovascular risk factors than the taking of simvastatin alone.~   "
208555|NCT00831116|"~     In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for~     use in detecting lipid core containing containing plaques of interest (LCP). These plaques~     are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary~     artery is unique to each patient. This study is an organized attempt to observe the LCP and~     the variety of ways that it presents in patients as detected by this recently approved~     device. This information will be used for physician training and to observe the behavior of~     the LCP in response to no therapy and currently approved therapies. The purpose of this~     project is further medical knowledge of the LCP and its treatment.~   "
208556|NCT00831103|"~     The purpose of this study is to determine the pharmacokinetics and dosage of EPB-348 that~     best balances safety and efficacy among adult immunocompetent patients with an acute episode~     of herpes zoster.~   "
208557|NCT00831090|"~     The purpose of this study is to better understand why some vein bypass grafts develop~     narrowing. Evidence suggests that there is a relationship between inflammatory markers in the~     blood and the narrowing that occurs in blood vessels. In this study, we will look at~     inflammatory markers in the blood and how well the vein graft functions.~   "
208558|NCT00831077|"~     The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and~     ORM-14540 in healthy volunteers.~   "
208559|NCT00831064|"~     To compare 4 commonly used bowel preparations in terms of efficacy, patient tolerability and~     safety. All these 4 bowel preparations are likely to be efficacious and safe. However, those~     with lower volume are likely to be better tolerated and completed by patients.~   "
208560|NCT00831051|"~     This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8~     mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride~     components for the management of acute moderate to severe postoperative pain following~     bunionectomy surgery.~   "
208561|NCT00831038|"~     Infants less than 2 years old who have been newly diagnosed with problems swallowing will~     have pulmonary function tests performed to try to detect the presence of chronic lung~     disease. Six months later after the infants have received appropriate therapy for their~     swallowing problems, pulmonary function tests will be performed again to see if there has~     been any change in their chronic lung disease.~   "
226815|NCT00588783|"~     The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate~     tibial component in total knee replacement.~   "
208562|NCT00831025|"~     The objective of this trial is to assess the clinical efficacy of a modified allergen extract~     of Olea europaea pollen in the treatment of patients affected by allergic~     rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to~     olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the~     medication.~   "
208563|NCT00831012|"~     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and~     subtropical regions of the world. The purpose of this study is to test the safety of and~     immune response to a new dengue virus vaccine in healthy adults.~   "
208564|NCT00830999|"~     This study is being conducted to learn more about the role of diet and exercise in regulating~     plasma triglyceride (fat) metabolism. The investigators will examine the effect of acute (24~     hour) changes in energy intake and expenditure on fat metabolism the following day.~   "
208565|NCT00830986|"~     A significant number of patients experience postoperative cognitive changes following total~     joint arthroplasty. Among other causes, the mental status change may be the result of fat and~     bone marrow debris embolization. We hypothesized that the use of computer assisted total knee~     arthroplasty, which does not utilize intramedullary alignment rods, would produce less fat~     and bone marrow debris embolization and, hence, fewer mental status changes.~   "
208566|NCT00830973|"~     This study will assess the impact of CYP450 2D6 genotype pharmacogenetic testing and the~     corresponding prescribing impact for postmenopausal women using tamoxifen in a patient care~     setting for prevention of recurrent breast cancer.~   "
208567|NCT00830960|"~     The study will compare the safety and efficacy of prasugrel, administered at different doses~     with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS)~     undergoing percutaneous coronary intervention.~   "
208568|NCT00830947|"~     To gather data indicating whether or not the OrthoAccel device speeds tooth movement in~     people who use orthodontics (braces).~   "
208569|NCT00830934|"~     The investigators aim to conduct a prospective open label randomized controlled trial to test~     the hypothesis that following initial assessment by a physiotherapist, group care exercise~     class is as effective in reducing pain as individual physiotherapy care.~   "
208570|NCT00830921|"~     The treatment we are studying is Transcranial Magnetic Stimulation (TMS). In TMS, an~     electromagnetic pulse is passed into the brain through a coil placed on the head. Previous~     studies have shown TMS to be capable of altering brain activity in specific areas; for~     example it has been used to improve mood in clinical depression. In this study we will assess~     if, by targeting TMS to the brain area responsible for feeling breathless, participants'~     breathlessness will be improved~   "
208571|NCT00830908|"~     The purpose of this study is to test whether the stimulation of vascularization and cellular~     metabolism on the scalp by use of the HairMax LaserComb will produce improvement in the~     condition of scalp seborrheic dermatitis.~   "
208572|NCT00830895|"~     To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell~     carcinoma~   "
208573|NCT00830882|"~     The objective of this study is to compare the peak dose relative bronchoprotection offered by~     levosalbutamol and racemic salbutamol in mild to moderate asthmatics preselected into two~     groups on the basis of their beta-2 adrenoreceptor polymorphisms.~   "
208574|NCT00830869|"~     This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary~     purpose of this study is to determine the safety profile, establish the maximum tolerated~     dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in patients with~     nonhematologic malignancies.~   "
208575|NCT00830856|"~     Cryptococcal Meningitis continues to be one of the most devastating AIDS defining illness in~     sub-Saharan Africa. Despite the availability of azoles such as fluconazole for treatment,~     mortality remains high with some studies showing 100% mortality. The investigators designed a~     study to determine if timing of the initiation of antiretroviral therapy (ART) in patients~     with cryptococcal meningitis and HIV would improve survival. The investigators hypothesis was~     that early initiation of ART result in improved mortality for patients with HIV and~     cryptococcal meningitis.~   "
208576|NCT00830843|"~     Recent study has shown that inhalatory sedation is a practicable, effective and not risky~     method in Intensive Care Unit. Sevoflurane effect on cerebral system have been described in~     previous studies: it causes an increasing of cerebral blood flow and a decrease of oxygen~     cerebral consumption. Clinical strategy for Subarachnoid Hemorrhage is orientated to increase~     cerebral blood flow to limit vasospasm phenomena after SAH. Scope of this study is to~     evaluate the Cerebral Blood Flow variation associated to Isoflurane sedation versus~     conventional sedation with propofol .~   "
208577|NCT00830830|"~     This extended study will evaluate the efficacy and safety of intra-articular injections of~     20mg/2ml dose HYALGAN in patients with pain due to osteoarthritis (OA) of the knee.~   "
208578|NCT00830817|"~     The purpose of this study is to evaluate primarily the safety and tolerability and~     secondarily the efficacy of topically applied WBI-1001 cream in patients with mild to~     moderate psoriasis. Double-blind, randomized, placebo controlled study of 36 patients,~     treated for 28 days plus a 7 day follow-up.in which the patients were divided into six~     cohorts: Cohort 1 at 0.5% QD;Cohort 2 at 0.5% BID; Cohort 3 at 1.0% QD; Cohort 4 at 1.0% BID;~     Cohort 5 at 2.0% QD; Cohort 6 at 2.0% BID.Efficacy assessed by PGA,target lesion assessment~     and BSA. Safety assessed through vital signs, ECG, AEs and Plasma PK via Cmin, Cmax,Tmax and~     AUCo-t.~   "
208579|NCT00830804|"~     The purpose of this study is to assess the effectiveness and safety of an antiretroviral~     therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as~     first-line therapy in treatment-naïve participants.~   "
208580|NCT00830791|"~     This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees~     of renal insufficiency.~   "
208590|NCT00830661|"~     Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving~     the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of~     intersphincteric fistula track (LIFT) procedure and the use of an anal fistula plug. The~     purpose of this study is to exam the rate of fistula closure between the LIFT procedure and~     the use of a fistula plug~   "
208727|NCT00828880|"~     The investigators hypothesize that a 6-week treatment of non-invasive spinal decompression~     reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in~     lumbar disc height is associated with decreased LBP.~   "
208581|NCT00830778|"~     The incidence of complications after pancreaticoduodenectomy (PD) is around 50 %. The~     postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula~     (POPF), which determines postoperative mortality, length of hospital stay and costs. The~     incidence of POPF after PD is dependent of its definition, and is reported in up to 20% of~     patients.~      There is disagreement on whether to perform a pancreaticojejunostomy (PJ) or a~     pancreaticogastrostomy (PG) after PD. The aim of the current randomized controlled trial is~     to study whether PG significantly reduces the rate of POPF following PD for pancreatic or~     peri-ampullary tumours. Secondary endpoints are the reduction of overall postoperative~     complication rate and their severity.~   "
208582|NCT00830765|"~     Preterm birth is the most common and costly complication in obstetrics. It complicates up to~     11 % of all pregnancies and it is responsible for 70% of sick babies. Recently two studies~     have shown that giving progesterone (a normal hormone made by the ovaries) prolongs gestation~     in women who have had a preterm birth in an earlier pregnancy (and therefore are at risk for~     another early delivery). There are other studies that show that this technique of giving a~     weekly shot of progesterone does not prevent preterm birth. In addition, There are other~     groups of patients who are at very high risk for preterm birth which have not been studied.~     They include: 1.) Cervical cerclage (a stitch in the mouth of the womb); 2.) Multifetal~     gestation (twins, triplets, etc.); 3.) Women with preterm (<34 weeks) rupture of the~     membranes; 4.) Women with preterm labor during the current pregnancy with intact membranes~     who have been tocolyzed (have their labor stopped and are getting ready to go home). We~     purpose to give weekly shots of progesterone or a placebo in a randomized fashion to women in~     the first group who are at risk for preterm delivery due to an early birth in a previous~     pregnancy as well as the other four groups listed. If progesterone given weekly is successful~     at preventing early delivery as compared to the placebo group then great benefit for these~     women as well as future pregnancies would be accrued.~   "
208583|NCT00830752|"~     The syndrome of extremely restricted emotional competence, alexithymia, was originally~     conceptualized in psychoanalytic research and is now empirically and experimentally studied~     in clinical psychology and psychological medicine within the context of emotion regulation~     using neuroscientific techniques. Alexithymia refers to an individual's inability or impaired~     ability to name or express feelings and to distinguish them from the physical consequences of~     an acute or chronic stress reaction. Modern brain-body-interface research suggests that~     alexithymia represents a complex deficiency in cognitive processing and emotional regulatory~     processes. The neurobiological basis is assumed to be a preconscious, automatic and~     involuntary information transfer to the amygdalae of acquired representations of emotional~     contents stored in ventromedial prefrontal cortical areas.~      Alexithymia is not just emotional coldness, i.e. a limited emotionality, but essentially~     the detachment of feelings from language. In alexithymia the link between affective phenomena~     and language, understood as media-supported sign practices, is insufficient or even absent.~      The purpose of our observational study is to better understand the neurobiological and~     neuropsychological as well as linguistic and gestural processes and determinants of this~     phenomenon~   "
208584|NCT00830739|"~     Background:~        -  Chronic nicotine exposure through cigarette smoking affects the level of the brain~          chemical dopamine. Smokers who attempt to quit experience lower levels of dopamine,~          which increases anxiety and triggers nicotine cravings that make quitting more~          difficult.~        -  Varenicline (Chantix) is a smoking cessation medication that is designed to reduce~          nicotine craving and withdrawal by slightly increasing levels of dopamine in the brain.~          Research has shown that varenicline is a safe, well-tolerated, and effective treatment~          for nicotine dependence, but researchers are interested in learning more about how it~          affects the brain and its function. Functional magnetic resonance imaging (fMRI) and~          electroencephalography (EEG) will help researchers study the brain s response to~          nicotine and varenicline.~      Objectives:~      - To explore how varenicline affects brain function and behavioral performance in current~     smokers and healthy volunteers.~      Eligibility:~      - Individuals between 18 and 55 years of age who are either current smokers (10 or more~     cigarettes per day) or healthy nonsmoking volunteers.~      Design:~        -  The study will involve nine testing and research visits over 5 to 6 weeks. The first~          visit will provide an initial assessment and training on the tasks that will be~          completed during the study.~        -  Six testing visits will involve fMRI and EEG measurements of brain activity. Each visit~          will contain two 2-hour scanning sessions, and each session will involve thinking tests.~          During these visits, participants will receive varenicline and placebo tablets, and wear~          nicotine patches and placebo patches that do not contain nicotine. Participants will not~          be told which tablet or patch they are given. This is a crossover study so all~          participants eventually get nicotine and placebo, as well as varenicline and placebo.~        -  Two other visits involve different thinking tasks. These visits will not require fMRI or~          EEG scans.~   "
208585|NCT00830726|"~     The purpose of the study is to determine whether the excretion of renal water- and~     salt-channels in the urine reflects the handling of water and salt in the kidneys, and~     whether the excretion can be used to monitor and/or predict the effects of treatment of~     certain heart or lung diseases.~   "
208586|NCT00830713|"~     In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for~     vitiligo takes the melanocytes from areas of normal skin and places them on areas of that~     same person's body which have lost their color. This is called the melanocyte-keratinocyte~     transplantation procedure (MKTP). This procedure has been used successfully in over 3000~     cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when~     performed at the investigators' institution.~   "
208587|NCT00830700|"~     While telemental health (TMH) programs are increasing nationally to address the inequity of~     access to psychiatric services, there are few reports of their efficacy, particularly with~     children. The current proposal will complete the second stage of our program development. In~     the first stage, we established the feasibility of a TMH service and its acceptability to~     families and PCPs. In the second stage of program development we will conduct a randomized~     clinical trial (RCT) that will determine whether it is possible to use technological advances~     to: 1) improve clinical outcomes for children with ADHD over outcomes achieved in usual PC;~     and 2) adhere to an EBT protocol implemented through TMH. Future studies will examine whether~     other types of complicated psychiatric disorders and EBTs are amenable to delivery via TMH.~      The overall goal of this study is to determine whether an evidence-based model of care can be~     faithfully implemented when delivered using TMH to children with ADHD living in rural areas~     and can improve outcomes over treatment as usual (TAU) in PC. ADHD is an excellent focus for~     assessment of TMH, as PCPs encounter this disorder frequently, EBT guidelines are available,~     pharmacotherapy is the core treatment and is easily delivered in PC through~     videoconferencing, and stabilization may be readily achieved for most youth.~   "
208588|NCT00830687|"~     The purpose of this study is to evaluate our experience in internal fixation of intracapsular~     femoral neck fractures with the Targon FN implant prospectively and retrospectively in terms~     of the outcomes and complications associated with the treatment.~   "
208591|NCT00830648|"~     The objective of the present study is to assess and document the safety of a second dose of~     Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having~     previously received a first dose of Varicella Biken vaccine.~      All subjects will receive a second dose of Varicella vaccine (Varicella Biken) at 4 to 6~     years of age.~      The expected total duration of follow-up (first visit to last visit) for each subject will be~     one month.~   "
208592|NCT00830635|"~     RATIONALE: A multimedia educational program may help patients with newly diagnosed prostate~     cancer and breast cancer reduce distress, make informed treatment decisions, and improve~     quality of life.~      PURPOSE: This randomized clinical trial is studying how well a multimedia educational program~     works in patients with early-stage prostate cancer or breast cancer.~   "
208593|NCT00830622|"~     A clinical study to evaluate the use of cell phones to support drug adherence and follow-up~     of patients taking antiretroviral therapy (ART) for treatment of HIV. The intervention~     involves health-care providers sending regular short-message-service (SMS) text messages to~     patients and following up their responses. The hypothesis is that the cell phone intervention~     will improve ART adherence and health outcomes compared with the current standard of care.~   "
208594|NCT00830609|"~     The rate of sustained virological response (SVR) in patients with chronic hepatitis C,~     genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week~     4) is low. Standard of care of these patients include treatment with weekly peginterferon~     plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more~     clinical benefit than the standard duration. The main hypothesis is that higher dose of~     ribavirin may be better in terms of SVR than the standard dose.~   "
208595|NCT00830596|"~     The long-term goal for this study is to understand the physiological mechanisms of various~     forms of spinal manipulation in order to refine and improve this therapy for appropriately~     selected patients. The objective of this study is to assess the effects of high-velocity~     low-amplitude spinal manipulation and low-velocity variable amplitude spinal manipulation on~     three types of sensorimotor abilities in patients with low back pain.~   "
208596|NCT00830583|"~     An international consensual group recommends confirming the diagnosis of the Pompe disease~     after a dried blood spot (DBS) with a dosage of the enzymatic activity in other tissue. This~     strategy is currently used in the usual practice.~      The aim is evaluate the prevalence of the Pompe disease among patients with progressive limb~     girdle muscular weakness and/or axial deficiency, and/or respiratory insufficiency. The~     diagnosis will be confirmed using DBS.~   "
208597|NCT00830570|"~     The purpose of this quasi-experiment study, which could also be classified as a prospective~     observational intervention study, is to assess the impact of cytochrome P450 2C9 (CYP 2C9)~     and vitamin K epoxide reductase complex, subunit 1 (VKORC1) testing within a primary patient~     care setting.~   "
208598|NCT00830557|"~     RATIONALE: Gathering medical information and collecting and storing samples of blood and~     tissue to test in the laboratory may help doctors develop better ways to screen people at~     risk for pancreatic cancer or other pancreatic disorders in the future.~      PURPOSE: This clinical trial is collecting medical information and tissue samples from~     patients with pancreatic cancer or other pancreatic disorders.~   "
208599|NCT00830544|"~     The purpose of this study is to evaluate the pathological CR rate in breast and lymph nodes~     of a novel neoadjuvant regimen for invasive breast carcinoma.~   "
208600|NCT00830531|"~     The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in~     newborns with refractory seizures. The overall hypothesis is that bumetanide, added to~     conventional antiepileptic (antiseizure) medications, will be a safe and well tolerated~     medication, compared with conventional antiepileptic drugs alone.~   "
208601|NCT00830518|"~     This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with~     acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).~   "
208602|NCT00830505|"~     The purpose of this study is to compare the effects of Fluticasone/ salmeterol combination~     and double the dose of fluticasone on airway hyper-responsiveness to methacholine.~   "
208603|NCT00830492|"~     Objective: To compare the efficacy of using mild ovarian stimulation protocol and~     conventional stimulation protocol in IVF outcome.~      Design: Prospective randomized trial~      Setting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile~     couple that women had regulary menstruation.~      Intervention(s): Patients were randomized to treatment clomiphene citrate, gonadotropin and~     GnRH antagonist (100 patients) or GnRH agonist and gonadotropin ( 100 patients).~      Main outcome measure: Clinical pregnancy rate.~      Key Words: clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization,~     pregnancy rate.~   "
208604|NCT00830479|"~     This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of~     low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of~     conventional open anti-reflux technique versus endoscopic anti-reflux technique with~     injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be~     resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence~     of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical~     complications, and quality of life measures after ARS.~   "
208605|NCT00830466|"~     The researchers want to collect data on safety and efficacy of combined pulsed dye laser and~     rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye~     laser alone, which is the current standard of care.~      This single center pilot and feasibility study will have a target enrollment of 40 port wine~     stain subjects at the Beckman Laser Institute and Medical Clinic, University of California,~     Irvine.~   "
208606|NCT00830453|"~     The purpose of this study is to discover the feasibility of conducting clinical research in~     individuals with chronic sequelae following brain injury who are given hyperbaric oxygen.~     This study will also look at the outcome of individuals with a chronic stable brain injury~     due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric~     oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength,~     etc.) measures will be performed before the hyperbaric sessions, immediately following them,~     and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the~     chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.~   "
208607|NCT00830440|"~     The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier~     device compared to a diet control in patients who require weight loss prior to their~     Bariatric surgery.~      It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry~     patients will receive an implant of the EndoBarrier device and the other 10 patients will~     receive the principle investigator's standard of care diet program. All patients will be~     treated for 12 weeks with the exception of the last 10 device patients who will continue to~     24 weeks if the principle investigator determines that it is safe and in their best interest~     to continue.~      The primary efficacy endpoint is:~        -  Assessment of the difference in % excess weight loss between the 2 groups~      Secondary endpoints are:~        -  Resolution or Improvement in type II Diabetic status as defined as:~        -  Resolution = patient is off their diabetes medication and has normal diabetic blood~          parameters (fasting glucose)~        -  Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction~          in dosing or frequency of their diabetic medication~        -  The percent of patients who achieve at least a 10% excess weight loss will be calculated~          as a secondary outcome.~   "
208608|NCT00830427|"~     This study (A7881006) is the first multiple dose study in moderate asthmatic subjects and~     aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a~     daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.~   "
208609|NCT00830414|"~     This study compared the rates and extents of medroxyprogesterone absorption from two~     medroxyprogesterone acetate injection formulations following single 150 mg intramuscular (IM)~     injections to healthy postmenopausal women.~   "
208610|NCT00830401|"~     This is a comparative, controlled trial to evaluate the impact of treating undetected,~     asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.~   "
208611|NCT00830388|"~     Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as~     a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to~     determine its effectiveness, safety and satisfaction when used to treat tinea versicolor.~   "
208612|NCT00830375|"~     This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.~   "
208613|NCT00830362|"~     The purpose of this study is to examine the effects of propranolol versus placebo on~     responses to cocaine cues in cocaine dependent individuals.~   "
208614|NCT00830349|"~     The objective of this study was to compare the rate and extent of absorption of risperidone 1~     mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablet under~     fasting conditions.~   "
208615|NCT00830336|"~     The study will compare the relative bioavailability (rate and extent of absorption) of 200~     mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.;~     distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension~     distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400~     mg) in healthy adult subjects administered under non-fasting conditions.~   "
208616|NCT00830323|"~     Neuraminidase inhibitors (NAI) are effective anti-influenza antiviral treatment. During their~     use in experimentally infected patients, it has been shown that the viral load detected in~     the nasal fluid is decreasing significantly faster than in non treated patients. During~     clinical practice, the emergence of NAI-resistant strains has been observed. These strains~     remain rare, but their emergence seemed to be related to the mis-use of the NAI products~     (insufficient duration or dosage). This observation as well as the detection of NAI-resistant~     viruses in the community raises concerns about putative emergence of resistant clones in the~     specific context of a pandemic, when the use of NAI will be very large in the aim of reducing~     transmission, and subsequently the impact of the emerging virus.~      In this context, it is important to determine the putative interest of alternative~     strategies.~      Although zanamivir and oseltamivir are both issued from the same class , this combination may~     lead to a more rapid viral clearance in the infected cases, and to a reduction in the~     emergence of resistant sub-clones, and alternatively, might lead to a competitive inhibition.~     The evaluation of these combinations needs to be conducted in vivo.~      Among available anti influenza antivirals, M2 blockers have been previously used. Although~     their efficacy against A H5N1 remains to be ascertained, their use in combination with NAI~     should also be evaluated in the context of a preparation for a possible pandemic and~     determination of the stockpile.~      Therefore, the evaluation of combination therapies in the treatment of a virologically~     suspected influenza will be investigated in primary care during the winter season 2008-2009.~   "
208617|NCT00830310|"~     This study is a modular intervention that is intended to improve treatment adherence among~     individuals with bipolar disorder on atypical antipsychotic therapy who have been identified~     as having treatment adherence problems.~   "
208618|NCT00830297|"~     Treat-to-target trial of basal Insulin in Post-transplant hyperglycemia (TIP): efficacy and~     safety of a novel protocol in renal transplant recipients receiving a tacrolimus-based~     immunosuppression~      DESCRIPTION:~      A prospective, randomized safety and efficacy study of long-acting insulin (Insulatard®) as~     therapy against post-transplant hyperglycemia in renal transplant recipients~      OBJECTIVES:~      Primary Objective:~      To demonstrate superiority of long-acting insulin (Insulatard®) against post-transplant~     hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c~      Secondary Objectives:~        -  To assess the average post-transplant glucose levels in renal transplant patients under~          conventional blood-glucose lowering therapy during a period of at least 14 days after~          transplantation by measuring the capillary blood glucose levels four times daily in both~          groups of patients (fasting, before lunch, before supper, after supper)~        -  To detect the number of post-transplant patients who - without any history of~          pre-transplant diabetes - develop at least one episode of post-transplant hyperglycemia~          (> 140 mg/dl before supper)~        -  To detect the average number of hyperglycemic episodes in post-transplant patients with~          at least one episode of post-transplant hyperglycemia and without any history of~          diabetes~        -  To assess the amount of (long-acting) insulin (in IU) needed in order to obtain a target~          capillary blood glucose level in the range of 110 mg/dl to 120 mg/dl before supper in~          post-transplant patients with incidence of hyperglycemia~        -  To assess the safety of long-acting insulin in controlling post-transplant hyperglycemia~          (especially with regards to episodes of hypoglycemia (glucose-level < 60 mg/dl)~        -  To assess the prevalence of post-transplant diabetes, as diagnosed by an abnormal oral~          glucose tolerance on days 90, 180 and 360 after transplantation, in the group of~          patients which has been treated with long-acting insulin, in comparison to patients who~          received conventional treatment~        -  To assess the morbidity (hospitalization, infections, subsequent episodes of surgery,~          requirement of non-immunosuppressive, non- blood glucose lowering medication) in the~          group of patients with long-acting insulin for hyperglycemia, in comparison to patients~          randomized into the group receiving conventional treatment~        -  To assess the renal outcome (creatinine levels, rejections) in the group of patients~          which is foreseen to be treated with long-acting insulin for hyperglycemia, in~          comparison to patients randomized into the group receiving conventional treatment~   "
208649|NCT00829894|"~     The objective of this study was to compare the rate and extent of absorption of risperidone 1~     mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed~     conditions.~   "
208650|NCT00829881|"~     This study will determine whether the drug betahistine increases focus and causes side~     effects in people with attention deficit hyperactivity disorder.~   "
227129|NCT00584532|"~     Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent~     in the treatment of localized prostate cancer.~   "
208619|NCT00830284|"~     Lung units which participate in gas exchange are known as 'recruited' lung. Patients with~     lung injury suffer from a proportion of units which do not participate in gas exchange (i.e.~     the derecruited state), which results in impaired gas exchange and induces an inflammatory~     cascade. Currently, there is no clinical practice guideline in our intensive care unit~     regarding lung recruitment strategies for children with lung injury. While many studies have~     demonstrated efficacy (ability to open the lung) and safety of recruitment maneuvers in~     adults, no such studies have been performed in children.~      The primary purpose of this study is therefore to demonstrate the safety and efficacy of a~     recruitment protocol designed to maximally recruit collapsed lung in children with acute lung~     injury. Each study patient will follow a recruitment protocol (see Appendix 2). Two~     'controls' will be utilized in this study: baseline ventilation (no recruitment maneuver) and~     the open lung approach (a sustained inflation followed by increased PEEP). Efficacy will be~     defined as an improvement in lung volume (as measured by nitrogen washout and electrical~     impedance tomography), and by an improvement in measured arterial partial pressure of oxygen.~     Safety will be defined as the incidence of barotrauma and hemodynamic consequences which~     occur during the protocol.~      A secondary purpose of this study will be to further validate electrical impedance tomography~     (EIT) as a non-invasive tool describing the lung parenchyma by comparing it to an accepted~     standard method of measuring lung volumes, the multiple breath nitrogen washout technique.~     Validation of EIT would allow clinicians to have a non-invasive image of a patient's lungs~     without the risks imposed by radiography.~      The information we learn will be instrumental in defining an optimal strategy for lung~     recruitment in children with lung injury.~   "
208620|NCT00830271|"~     This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with~     antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery.~   "
208621|NCT00830258|"~     The objective of this study is to evaluate the comparative bioavailability between~     pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80~     mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting~     conditions.~   "
208622|NCT00830245|"~     To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with~     leptomeningeal carcinomatosis~   "
208623|NCT00830232|"~     The goal of the proposed study is to contrast the relative efficacy of closed-cell stents~     versus open-cell stents in preventing periprocedural cerebral embolization in high-risk~     patients with symptomatic and asymptomatic extracranial carotid stenosis undergoing carotid~     artery stenting (CAS).~   "
208624|NCT00830219|"~     The purpose of this study is to compare relative bioavailability of the test formulation of~     ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA~     Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride)~     0.25 mg tablets (GlaxoSmithKline) under fed conditions in healthy, adult subjects.~   "
208625|NCT00830206|"~     The study will compare the relative bioavailability (rate and extent of absorption) of 200~     mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.;~     distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX®.~   "
208626|NCT00830193|"~     Critically ill patients frequently undergo contrast enhanced computed tomography (CT) to~     establish diagnoses and direct management. Contrast agents can disturb kidney function and~     result in kidney dysfunction. The investigators investigated the effects of high dose~     N-acetylcysteine (NAC) or placebo, in addition to hydration, in preventing kidney dysfunction~     following contrast enhanced CT) in critically ill adults in the intensive care units of two~     teaching hospitals.~   "
208627|NCT00830180|"~     To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone~     metastases who participated in the double-blind Study A4091003 and who wish to receive~     open-label therapy.~   "
208628|NCT00830167|"~     This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the~     efficacy and safety of pregabalin in patients with fibromyalgia.~   "
208629|NCT00830154|"~     A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy,~     safety and tolerability of pagoclone for adults with stuttering.~   "
208630|NCT00830141|"~     Obesity, now a global epidemic, is a leading cause of illness and mortality in the developed~     world. To better understand the pathophysiological mechanisms that underlie weight disorders,~     increasing attention is being paid to central regulatory elements in energy homeostasis,~     including food intake and energy expenditure. The human hormone ghrelin is secreted as a~     preprohormone (preproghrelin), from which two hormones with antagonistic effects are derived:~     ghrelin, which has orexigenic effects and obestatin, which has anorexigenic effects.~     Ghrelin's actions are mediated by GH secretagogue receptor (GHSR). Ghrelin synthesis occurs~     predominantly in epithelial cells of the fundus of the stomach. . As the ligand for GHSR,~     ghrelin stimulates secretion of GH. In both rodents and humans, ghrelin regulates hunger~     though its action on hypothalamic feeding centers. Other effects of ghrelin include~     stimulating gastric emptying, positive effects on cardiovascular function, increasing~     intestinal peristalsis, and positive exocrine and paracrine pancreatic secretion. Despite its~     important physiological role, its precise regulatory mechanisms remain ambiguous. Thus, it~     has been suggested that mutations in ghrelin and its receptor will present clinically with~     obesity, eating disorders or growth disturbances. To date, only four different mutations have~     been reported in GHSR and no mutations have been found in the ghrelin gene.~      Working hypothesis and aims: We hypothesize that mutations in ghrelin or in its receptor,~     GHSR, affect appetite regulation and cause growth and eating disorders.~   "
208631|NCT00830128|"~     This study will assess the safety and efficacy of the long-term use of pregabalin at doses up~     to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study~     A0081208 (NCT00830167).~   "
208632|NCT00830115|"~     The aim of the study was to evaluate the effect of pantoprazole on sleep disorders in~     patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux~     disease). The prevalence and intensity of the sleep disorders were evaluated by a~     standardized questionnaire. The study was expected to provide further data on safety and~     tolerability of pantoprazole.~   "
208633|NCT00830102|"~     The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo~     or fluticasone and formoterol administered concurrently or alone in asthma patients.~   "
208651|NCT00829868|"~     The objective of this study is to compare the relative bioavailability of zaleplon 10 mg~     capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg~     capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under~     non-fasting conditions.~   "
208728|NCT00828867|"~     This is a first time in human (FTIH) study of single escalating doses of investigational~     study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects~   "
208634|NCT00830089|"~     Keyhole surgery for bowel disease has brought great benefits, enabling patients to recover~     quicker from surgery and so return to normal activities. Although keyhole surgery reduces~     pain following abdominal surgery, it still causes enough pain to require strong pain killing~     medications such as morphine-like drugs which, although good pain killers, can have a~     detrimental effect on the recovery of bowel function, leading to feelings of nausea and~     vomiting and ultimately delaying recovery. These side-effects can reduce the potential~     benefits from keyhole surgery and our fast-track recovery programmes.~      The aim of this project is to assess the effectiveness of a new method of pain control after~     keyhole bowel surgery. The study involves the injection of local anaesthetic into the~     abdominal muscles once the patient is anaesthetised. Although use of local anaesthetic is~     common practice, we are looking at a new technique of injecting it called a transversus~     abdominis plane (or TAP) block. This technique will attempt to block the pain nerves to the~     abdomen prior to the operation beginning. We plan to investigate whether this new technique~     will reduce the amount of pain following keyhole bowel surgery. If successful, it might be~     used to further enhance people's recovery from bowel surgery.~   "
208635|NCT00830076|"~     This study will assess the effects of sitagliptin and metformin alone and after~     co-administration on incretin hormone concentrations in patients with Type 2 diabetes.~   "
208636|NCT00830063|"~     The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared~     with naproxen and placebo in patients with osteoarthritis.~   "
208637|NCT00830050|"~     The study hypothesis is that the relief of pain in patients with osteoarthritis in the hand~     can be detected by a form of brain scanning that detects which parts of the brain are~     activated when pain is felt.~   "
208638|NCT00830037|"~     The long-term goal is to assess the fall in kidney function measured by glomerular filtration~     rate (GFR) when patients with chronic kidney disease (CKD) are exposed to intravenous iron~     (IVIR). We hypothesize that in subjects with mild to moderate CKD, infusion of intravenous~     iron (IVIR), will generate oxidative stress and cause an inflammatory response that will be~     associated with a more rapid decline in glomerular filtration rate (GFR) compared to oral~     iron.~   "
208639|NCT00830024|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg~     Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA~     with that of 3 mg XANAX XR® Tablets by Pharmacia & Upjohn Company following a single oral~     dose (1 x 3 mg extended release tablet) in healthy adult subjects administered under~     non-fasting conditions.~   "
208640|NCT00830011|"~     The primary objective of this study is to evaluate the usefulness of cognitive behavioral~     therapy (CBT) for the management of painful diabetic neuropathy. Participants will be~     randomly assigned to one of two treatment conditions: CBT plus standard medical care or~     standard medical care alone. CBT will be offered in ten, ninety-minute group sessions and~     will be provided by a psychologist with experience in the management of both diabetes and~     chronic pain. CBT will involve teaching and encouraging practice of adaptive pain coping~     skills such as relaxation skills, activity pacing, and positive self-statements, among~     others. This study will allow us to determine which treatment is superior in terms of~     improvements in pain management, functioning and overall quality of life.~   "
208641|NCT00829998|"~     The objective of this study was to compare the relative bioavailability of Zaleplon 10 mg~     Capsules manufactured by TEVA Pharmaceuticals USA and Sonata® 10 mg Capsules manufactured by~     Wyeth Laboratories in healthy, non-smoking adults under fasting conditions.~   "
208642|NCT00829985|"~     There is currently no effective way to prevent development of allergic rhinitis (nasal~     allergies) and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in~     which allergens are placed under the tongue, may be a way to control and possibly prevent~     allergic rhinitis and asthma. However, detailed research of this approach is limited. The~     purpose of this study is to evaluate the safety and efficacy of a sublingual cockroach~     extract given to adults with perennial allergic rhinitis, asthma, or both.~   "
208643|NCT00829972|"~     The investigators aim to evaluate the levels of serum Vitamin D in children having their~     tonsils removed and appropriate controls. The investigators hypothesize that children~     undergoing tonsil removal will have lower Vit D levels than accepted norms and when compared~     to controls. The investigators also hypothesize that Vitamin D deficiency will correlate with~     indicators of inflammation such as C-Reactive Protein (CRP) and tonsil size.~   "
208644|NCT00829959|"~     Objectives:~      - To evaluate the attitudes and opinions of women undergoing genetic counseling for~     hereditary breast and ovarian cancer syndrome, both before and after testing, in regards to~     pregnancy and fertility~      Hypothesis:~      -Factors that will increase the percentage of women endorsing prenatal diagnostic testing~     will include a personal history of breast or ovarian cancer, having had a mother or sister~     die of breast or ovarian cancer, and testing positive for a BRCA mutation.~   "
208645|NCT00829946|"~     The purpose of the present randomized controlled trial was to determine the effects of a~     3-month resistance training program (2 sessions/week) on the functional mobility and muscle~     function, muscular dynamic strength, body composition and quality of life of young anorexic~     outpatients (≤16 years). The investigators also assessed cardiorespiratory variables of~     clinical significance such as peak oxygen uptake.~   "
208646|NCT00829933|"~     The primary objective of this study is to compare the incidence of hemorrhagic events in~     patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus~     warfarin potassium (warfarin). The secondary objective includes between-group comparisons~     with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers~     for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for~     the safety evaluation.~   "
208647|NCT00829920|"~     The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients~     with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at~     least transiently, in a fraction of patients after treatment. To investigate this hypothesis,~     investigators will assess the levels of CTCs both before and after treatment. The feasibility~     and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.~   "
208648|NCT00829907|"~     The purpose of the study is to evaluate the effect of ORM-12741 on receptor occupancy by~     positron emission tomography with different doses and plasma concentrations. The~     pharmacokinetic profile and safety will also be evaluated.~   "
208652|NCT00829855|"~     Acute cardiogenic pulmonary edema (ACPE), one of the most severe forms of acute heart~     failure, represents 5% of hospital admissions. One of the most frequent phenomena encountered~     during ACPE is hypertensive crisis (hypertensive ACPE) but the mechanisms and causes of~     hypertensive ACPE are insufficiently understood. Few studies have evaluated the cardiac~     function during hypertensive ACPE, and these studies used only conventional echocardiography~     methods. New methods of evaluation of cardiac function in hypertensive ACPE (such as Tissue~     Doppler imaging) have not been used.~      The objectives of this study are to evaluate presence and role of the following potential~     mechanisms of hypertensive ACPE: 1. acute myocardial dysfunction (systolic and diastolic); 2.~     silent transient myocardial ischemia; 3. acute mechanical left ventricular dyssynchrony; 4.~     dynamic mitral regurgitation; 5. inter-ventricular interaction. Conventional and Tissue~     Doppler echocardiography will be used to assess cardiac function.~   "
208653|NCT00829842|"~     Hospital infections play an important role in the increase of patients' morbimortality and~     hospitalization costs, especially in the case of individuals admitted to intensive care units~     (ICU) during postoperative heart surgery. Analysis of the epidemiological profile of the~     hospital infections in the pediatric-ICU (P-ICU) of Hospital das Clínicas da Faculdade de~     Medicina de Ribeirão Preto, University of São Paulo (HCFMRP-USP) demonstrated a 31.1%~     incidence of pneumonia (PNM) and a rate of ventilator-associated pneumonia (VAP) of 23.81 per~     1000 ventilators-day between March 2004 and February 2005 in the group submitted to cardiac~     surgery. Knowledge of the pathophysiology and risk factors associated with this infection~     allows for measures aiming at reducing its incidence. The objective of the present study is~     to evaluate the effect of oral hygiene with a 0.12% chlorhexidine solution on the incidence~     of PNM and PAV in children submitted to cardiac surgery.~   "
208654|NCT00829829|"~     The purpose of this clinical research study was to determine the safety and effectiveness of~     an experimental drug called rilonacept in subjects with gout who are beginning allopurinol~     treatment for gout. Subjects will participate in this study for approximately 22 weeks.~     Rilonacept is being studied for use in preventing allopurinol-induced gout flares.~   "
208655|NCT00829816|"~     The purpose of this study is to evaluate the safety and tolerability of dimebon given to~     Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine~     plus donepezil.~   "
208656|NCT00829803|"~     Establish the range of index values for the SNAP II corresponding to each anesthetic state~     studied.~   "
208657|NCT00829790|"~     The objective of this study was to compare the rate of absorption and the oral~     bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral~     suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals~     USA to an equivalent oral dose of the commercially available reference product, Vibramycin~     Monohydrate® manufactured by Pfizer, Inc. Following an overnight fast of at least 10 hours,~     subjects consumed a standard high-calorie. high-fat breakfast meal. This standard breakfast~     meal began 30 minutes prior to each dose.~   "
208658|NCT00829777|"~     The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol~     administered to opiate dependent subjects~   "
208659|NCT00829764|"~     The objective of this single-dose, open-label, randomized, two-period crossover study was to~     compare the rate of absorption and oral bioavailability of a test formulation of doxycycline~     monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and~     distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially~     available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. following~     an overnight fast of at least 10 hours.~   "
208660|NCT00829751|"~     The purpose of this study is to more objectively evaluate potential lens-material/care~     solution bio-incompatibilities. We will do this by measuring corneal staining and the amount~     of fluorescein dye diffusion into the eye.~   "
208661|NCT00829738|"~     The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg~     and 20 mg on gastroesophageal reflux disease (GERD) related symptoms in a large patient~     population.~   "
208662|NCT00829725|"~     The purpose of this study is to compare between two methods of internal fixation, the 3-4~     parallel screws or the Targon FN implant in gardens type 1-2 or Pauwels type 1-2 femoral neck~     fractures in terms of the outcomes and complications associated with the treatment of these~     fractures.~   "
208663|NCT00829712|"~     The objective of this randomized, single-dose, two-way evaluation is to compare the~     bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral~     dose of the commercially available dexmethylphenidate hydrochloride in a test population of~     24 adult subjects under fasted conditions.~   "
208664|NCT00829699|"~     The purpose of this study is to learn more about why patients with diabetes have increased~     heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood~     vessel. The proposed protocol will study the separate and combined effects of high glucose~     and high fats on certain cardiovascular responses in Type 2 DM.~   "
208665|NCT00829686|"~     Patients will be enrolled in a multi-center study to prospectively evaluate outcome after~     treatment for an uncomplicated skin abscess. All patients will receive incision and drainage~     and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bacterium~     double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the~     dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion~     in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the~     emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome~     is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within~     30 days of treatment. Patients who are not improving at the following visit will then be~     treated with additional antibiotics or admission if needed. Data will be analyzed both by~     initial randomization and intention to treat. This serves as the pilot for the full placebo~     controlled randomized trial.~   "
208666|NCT00829673|"~     The objective of this randomized, single-dose, two-way evaluation is to compare the~     bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral~     dose of the commercially available dexmethylphenidate hydrochloride (Focalin®, Novartis~     Pharmaceuticals Corporation) in a test population of 24 adult subjects under fed conditions.~   "
216421|NCT00726674|"~     Treatment of diabetes mellitus type II with basal insulin, for patients treated in Clalit~     outpatient clinics that are not adequately controlled with current treatment.~   "
208667|NCT00829660|"~     The purpose of this study is to determine whether acarbose therapy can reduce~     cardiovascular-related morbidity and mortality in patients with impaired glucose tolerance~     (IGT) who have established coronary heart disease (CHD) or acute coronary syndrome (ACS). A~     secondary objective of the study is to determine if acarbose therapy can prevent or delay~     transition to type 2 diabetes mellitus (T2DM) in this patient population.~   "
208668|NCT00829647|"~     Dasatinib and lenalidomide are both prescribed for use in patients with different cancers of~     the blood. This study is experimental because neither drug has been approved by the Food and~     Drug Administration for the treatment of chronic lymphocytic leukemia. There are few standard~     treatments when fludarabine is no longer effective in patients with CLL. Some patients have~     received additional combination therapy with fludarabine, Campath, bone marrow transplants or~     supportive care. Dasatinib and lenalidomide have been effective in high-risk CLL patients in~     other pilot mono therapy studies. The combination of dasatinib and lenalidomide has not been~     studied in humans before and this study is designed to test whether this combination is safe~     to use.~   "
208669|NCT00829634|"~     The intent of this study is to see if the rate that the body breaks down l-methamphetamine~     (l-MA) could be used as an accurate estimate for the rate that the body breaks down~     d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA~     is the commonly abused form of methamphetamine.~   "
208670|NCT00829621|"~     People who have been scheduled for surgery using Bone Morphogenic Protein (called BMP-2) and~     an incisional vacuum assisted closure device (called IVAC) will be asked to join this study.~      The purpose of this study is to see if using the IVAC device removes BMP-2 from the wound.~     BMP-2 is a protein used by the body to increase bone healing, decrease the need for~     additional surgery, and reduce infection rates.~      The IVAC is a device that involves a foam dressing secured with an adhesive drape to make an~     airtight seal over a surgical incision. Tubing runs from the foam dressing to a device that~     uses gentle suction to drain fluid out (like a vacuum). The IVAC stays on for 48-72 hours~     depending on amount of drainage. The IVAC by itself helps reduce wound swelling and~     complications (such as infection).~   "
208671|NCT00829608|"~     The purpose of this study is to determine if administration of the HPV quadrivalent vaccine~     in patients diagnosed with RRP has a therapeutic effect on their clinical course. More~     specifically, does administration of the vaccine decrease the size and number of papillomas,~     severity of disease (i.e. hoarseness, inspiratory vs. biphasic stridor, airway obstruction)~     using the LCAS and time interval between required surgical debulking will be analyzed.~   "
208672|NCT00829595|"~     Patients with inflammatory bowel disease (IBD) will be assessed for immunologic response to~     pneumococcal vaccination. Patients with IBD meet criteria as outlined by the Centers for~     Disease Control (CDC) for pneumococcal vaccination, yet the investigators have found that~     pneumococcal vaccination in this population is under-utilized. It is unknown whether or not~     IBD or IBD-related medications impact the immune response to this recommended vaccine.~      Three groups of 25 patients each will be recruited. The first group will consist of~     outpatients with IBD who are receiving infliximab (Remicade TM) while on concommitant~     immunosuppressive therapy (with either 6MP, azathioprine, or methotrexate). This group is~     intended to represent a common 'heavily immunosuppressed' patient group with IBD.~      The second group will consist of patients with IBD seen in our outpatient clinic who are not~     on any immune-suppressive medications. These patients meet CDC criteria for vaccination by~     virtue of having a chronic medical illness. The third group will consist of healthy~     age-matched (to the first group) controls.~      After obtaining informed consent, patients will be screened with baseline lab tests including~     testing for antibodies against pneumococcus. At the baseline visit, patients will also~     undergo a brief medical history, physical examination, and assessment of their IBD disease~     activity.~      Included patients will then undergo a one-time intramuscular vaccination with 23-valent~     polysaccharide pneumococcal vaccine (Pneumovax TM). One month later, subjects will return for~     a blood draw to assess for response to pneumococcal vaccination.~   "
208673|NCT00829582|"~     Title: Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the~     Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204 (AnthimTM)~      Population: This study will determine the safety, tolerability and pharmacokinetics of a~     single iv dose of ETI-204 in subjects 18 to 50 years of age. Three cohorts will be studied~     sequentially: subjects receiving 120 mg, 240 mg and 360 mg of ETI-204. The study will be~     randomized, double-blind, and stratified by gender. Each cohort will contain 15 subjects~     (including at least four females), twelve who will receive ETI-204 and three who will receive~     placebo.~      Study Objectives: To determine the safety, tolerability and pharmacokinetics of ETI-204~     following a single intravenous administration.~   "
208674|NCT00829569|"~     The purpose of this experimental study is to investigate whether an acute lipid infusion~     added marine n-3 fatty acids produces effects on insulin sensitivity in subjects with type 2~     diabetes, when compared with an acute lipid infusion without marine n-3 fatty acids.~     Furthermore other effects on intermediary metabolism are tested for.~   "
208675|NCT00829556|"~     This study is being conducted to investigate the potential benefits of using a special type~     of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin~     preparation in patients undergoing total hip replacement (THA) or total knee replacement~     (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and~     other problems. This study will investigate whether Integuseal is effective in reducing~     persistent wound drainage when used in addition to standard surgical skin preparation for~     total hip arthroplasty (THA) or total knee replacement (TKA).~   "
208676|NCT00829543|"~     This study is designed to evaluate the efficacy and safety of guide-free sacroiliac joint~     (SIJ) injection in refractory sacroiliac pain due to spondyloarthropathies.~   "
208677|NCT00829530|"~     The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg~     capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fed~     conditions.~   "
208729|NCT00828854|"~     The addition of SNDX-275 to an AI will result in a maximal abrogation of estrogen receptor-α~     mediated activity and inhibit mechanisms of resistance to the aromatase inhibitor.~      It is hypothesized that SNDX-275 with continued AI will increase the estimated AI clinical~     benefit rate (CBR) from 5% to 25% with an acceptable safety profile.~   "
208678|NCT00829517|"~     This project seeks to demonstrate that computer kiosks in a clinic waiting room can improve~     access to hormonal contraception and screening for sexually transmitted infections. The study~     will be a randomized controlled trial which will evaluate the use of a computer kiosk module~     to compare the proportion of women of reproductive age who receive a prescription for~     hormonal contraception when computer-assisted provision of hormonal contraception is offered~     (intervention) to encounters when the study clinic provides standard contraceptive care~     (control). Subjects will be contacted approximately 3 months (range 2-4 months) after the~     clinic visit to complete a follow-up phone interview. The study population will include~     English and Spanish-speaking women ages 18-45 who seek care at this clinic. Our hypothesis is~     that computer-assisted provision of hormonal contraception (intervention)will increase the~     proportion of women of reproductive age who receive a prescription for hormonal contraception~     versus standard contraceptive care(control).~   "
208679|NCT00829504|"~     The objective of this study was to compare the relative bioavailability of the test~     formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of~     Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under~     fasting conditions in healthy, non-smoking, adult subjects.~   "
208680|NCT00829491|"~     The objective of the Denver Health CVD Prevention Program is to assess the effectiveness of~     developing an enhanced cardiovascular disease prevention program in a community health care~     setting.~   "
208681|NCT00829478|"~     The primary aim of this proposal is to determine the effectiveness of a decision support tool~     on improving the process of shared decision-making for treatment on nonvalvular atrial~     fibrillation (NVAF) compared to receipt of usual care.~   "
208682|NCT00829465|"~     Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more~     than 28%. After diagnosis, the average survival rate of patient is less than 50% in 6 month,~     less than 24% in 1 year and 5% in 5 year. The TACE treatment, under the theoretical basis of~     blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in~     terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of~     life. However, its overall effect is not yet satisfactory. As a result, concerning the~     research of drug for liver cancer and improving the overall efficacy of the treatment of~     liver cancer has a very real and important clinical significance and social value. Licartin~     (Iodine-131-Labeled Metuximab) injection is a antibody drug with new target and the only drug~     that China own the intellectual property rights. It has specific high affinity with~     HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue,~     owning high-dose concentration and releasing β particles to liver cancer cells to and kill~     cancer cells.~      The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use~     the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular~     carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival~     rate between different treatment group.~   "
208683|NCT00829452|"~     The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg~     capsule (test) versus Altace® (reference) administered as the content of 1 x 10 mg capsule~     mixed with applesauce under fasting conditions.~   "
208684|NCT00829439|"~     This study is designed to determine the highest dose of levodopa/carbidopa that can be~     tolerated without any serious side effects by children with Angelman syndrome.~      It has been hypothesized that levodopa may lead to an improvement in the neurodevelopment and~     abnormal movements (e.g. tremors) in children with Angelman syndrome.~      Data from this study will be used to design a phase II trial to determine the efficacy of~     levodopa in treating children with Angelman syndrome.~   "
208685|NCT00829426|"~     This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg~     Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA~     with that of 3 mg XANAX XR® Tablets by Pharmacia & Upjohn Company following a single oral~     dose (1 x 3 mg extended release tablet) in healthy adult subjects administered under fasting~     conditions.~   "
208686|NCT00829413|"~     The purpose of this study is to demonstrate the Sensitivity and Specificity of~     SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the~     characterization of benign versus malignant FLLs using final diagnosis based on histology or~     combined imaging (CE-CT and/or CE MRI)/clinical data as truth standard.~   "
208687|NCT00829400|"~     The purpose of this study is to determine whether augmenting work services with cognitive~     remediation can improve vocational outcomes for psychiatrically disabled participants in VA~     work services.~   "
208688|NCT00829387|"~     The purpose of this study is to evaluate the efficacy of a brief psychological intervention,~     cognitive-behavior therapy, for the management of persistent pain associated with diabetic~     peripheral neuropathic pain.~   "
208689|NCT00829374|"~     The purpose of this study is to determine if Dimebon is safe and effective in patients with~     mild to moderate Alzheimer's disease on Donepezil.~   "
208690|NCT00829361|"~     The STARR network registry consists of a 4 spoke 1 hub system. Which will consist of~     prospective collection, recording, and regular analysis of telestroke patient consultation~     and care data for the purpose of quality measure assessment and improvement and benchmarking~     against other national and international telestroke programs.~   "
208691|NCT00829348|"~     The objective of the study is to determine whether short text massages could be used~     successfully as a compliance aid and improve clinical outcomes in long term lipid lowering~     therapy.~   "
208692|NCT00829335|"~     Anatomical resection is the gold standard approach for liver resection in patients with HCC.~     A new method for that by means of IOUS-guided finger compression has been devised.~   "
208704|NCT00829179|"~     A single center pilot study to determine the protective effects of RhuMAB-E25 on airway~     physiology and biology in allergic asthmatics that undergo bronchoprovocation with~     methacholine.~      The primary study objective determines the protective impact of RhuMAB-E25 on airway~     inflammation as reflected in exhaled nitric oxide (NO) levels in allergic asthmatics.~      The secondary objective determines the protective effect of rhuMAB E25 against airway~     bronchoconstriction as reflected in the Provocative Concentration of methacholine to cause a~     20% fall in FEV1(PC20) with methacholine challenge testing.~   "
214014|NCT00758537|"~     Tryptophan metabolism in kidney disease will be investigated in patients with chronic kidney~     disease stages (ADOQI 3-5). Tryptophan levels and respective catabolites will be assessed~     under hemodialysis.~   "
208693|NCT00829322|"~     Fatigue is a persistent, subjective sense of tiredness, which interferes with a person's~     usual ability to function. It is believed to be both the most common and the most distressing~     symptom experienced by those with cancer. Despite the magnitude of the problem, there has~     been inadequate research into the management of cancer-related fatigue.~      Central nervous system (CNS) stimulants are the only class of drug established as being~     directly effective in relieving fatigue. Traditional stimulants, such as methylphenidate~     (Ritalin), can cause side-effects such as difficulty sleeping at night and anxiety. Modafinil~     is a relatively new stimulant with few side-effects. There is increasing evidence that~     modafinil can reduce fatigue in healthy individuals and patients with chronic, non-cancer~     conditions. No good quality studies have been published evaluating modafinil in patients with~     cancer, despite multiple calls for such research to be undertaken.~      The investigators have completed a small study to determine the feasibility of undertaking a~     larger, high quality study to assess the effect of modafinil on fatigue in patients with lung~     cancer. Modafinil appeared to improve fatigue rapidly and was not associated with serious~     side-effects. Ten of the fifteen patients who completed the study chose to continue modafinil~     long-term. However, the study was too small for definite conclusions to be drawn.~      This larger, definitive study, funded by a National Cancer Research Institute research award,~     will establish more clearly whether modafinil can improve fatigue in patients with lung~     cancer. Two hundred and six patients will be recruited from a number of sites across the UK.~     Half of the patients will take modafinil, and the other half will take a 'dummy' tablet every~     day for a month. The fatigue levels of the two groups will be compared. Confirmation that~     modafinil can relieve cancer-related fatigue could have a highly significant impact on the~     quality of life of the very large number of patients suffering from this common and~     distressing symptom.~   "
208694|NCT00829309|"~     This study compared the relative bioavailability (rate and extent of absorption) of~     Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd. with that of~     Pravachol® Tablets 80 mg by Bristol-Myers Squibb Company following a single oral dose (1 x 80~     mg tablet)in healthy adult male subjects administered under non-fasting conditions.~   "
208695|NCT00829296|"~     The study is being done to see if a drug shown to lower the risk of heart failure is also~     effective in reducing the stiffness of the arteries.~   "
208696|NCT00829283|"~     This controlled study will test the effectiveness of a stepped-care approach to a standard~     behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The~     major question is whether the stepped-care approach, which begins with behavioral weight loss~     and then follows a decision tree for additional interventions based on early treatment~     response is superior to standard behavioral treatment.~   "
208697|NCT00829270|"~     Mitochondrial diseases are the most frequent metabolic diseases (2.5 persons among 10 000)~     and are clinically heterogeneous making diagnosis particularly challenging for clinicians.~      Molecular analysis of mitochondrial DNA (mtDNA) is a critical step in diagnosis and genetic~     counselling of respiratory chain defects. DNA sequencing remains the gold standard but it is~     time-consuming and fails to detect mutations that may be present at a low heteroplasmic level~     (20% or below); therefore the diagnosis is yet based on the detection of a few number of~     pathogenic mutations.~      The present study aims to evaluate the benefit and the cost of a diagnosis strategy based on~     the combined use of 2 techniques named Surveyor Nuclease and Mitochip. Surveyor nuclease~     is a mismatch-specific DNA endonuclease that will be used for screening the entire mtDNA in~     order to identify heteroplasmic mutations. In absence of any identified mutation, another~     technique based on the use an oligonucleotide sequencing microarray (MitoChip) will be~     performed for the identification of homoplasmic mutations. Mitochip is an array-based~     sequencing platform for rapid and high-throughput analysis of mitochondrial DNA.~      The economical study will compare the cost of these techniques to the standard diagnosis~     method in term of direct and indirect costs~   "
208698|NCT00829257|"~     The purpose of this study is to establish whether addition of extra-fine particle steroid~     inhalers achieve additional suppression of small airways inflammation when added to~     'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.~   "
208699|NCT00829244|"~     The overall objective of this trial is to compare the ovarian response in assisted~     reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in~     recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment'~     (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per~     day.~   "
208700|NCT00829231|"~     This study is to find out how the subject's body processes and reacts to the study drug, and~     to find out how long it remains in the subjects system after one dose. Subjects with varying~     degrees of liver function are being asked to participate in this study. Study results from~     subjects with normal liver function will be compared with study results from subjects with~     impaired liver function.~   "
208701|NCT00829218|"~     Objective: Randomized, double blind, placebo-controlled, crossover, clinical trial to examine~     the effects of the food additive glutamate (in the form of MSG) on IBS and fibromyalgia.~      Setting and Subjects: The Fibromyalgia Research Database at OHSU will be utilized to identify~     and recruit fibromyalgia patients who also have IBS to OHSU study centers.~      Intervention: Approximately 60 male and female subjects aged 18-75 will be placed on a~     1-month glutamate-free elimination diet. Those that respond positively to the diet (we are~     estimating 30-40 subjects), will then be randomized to receive either a citrus drink~     containing 5 grams of MSG; or placebo (the citrus drink alone)on three consecutive days one~     week apart.~      The investigators are hypothesizing that those who react positively to the elimination diet~     will have symptom occurrence statistically more frequently when given the glutamate~     challenge, than when given placebo.~   "
208702|NCT00829205|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer cell-killing substances to them. Drugs used in~     chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Se-methyl-seleno-l-cysteine may help reduce the side effects of chemotherapy.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of~     Se-methyl-seleno-l-cysteine when given together with rituximab, ifosfamide, carboplatin, and~     etoposide and to see how well it works in treating patients with diffuse large B-cell~     lymphoma that has relapsed or not responded to treatment.~   "
208703|NCT00829192|"~     The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in~     reducing the number of actinic keratoses and squamous cell carcinomas developing in immune~     compromised organ transplant recipients, who are at particularly high risk, over a 24 month~     test period.~      The number of lesions formed on the head, hands and forarms will be monitored over this 24~     month test period.~   "
208723|NCT00828932|"~     The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is~     required in patients with mild or moderate hepatic impairment.~   "
208705|NCT00829166|"~     This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial~     designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of~     capecitabine + lapatinib in participants with human epidermal growth factor receptor 2~     (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated~     until disease progression (PD), unmanageable toxicity, or study termination. Once disease~     progression is reported, all participants will be followed for survival every 3 months until~     death, loss to follow-up, withdrawal of consent, or study termination.~   "
208706|NCT00829153|"~     The requirements for haemodialysis are increasing. There is now acceptance that the most~     durable AV fistulae are those created from the patients own veins. Use of the radiocephalic~     arteriovenous fistula as an autologous vascular access dates back to the 1960's. (Brescia MJ,~     Cimino JE. Appel K, Hurwich BJ. Chronic hemodialysis using venipuncture and a surgically~     created arteriovenous fistula. N Engl J Med 1966; 275: 1089 - 1092.) Once established, it has~     good long term survival and a low complication rate. However, the success rate at creation of~     a useable AV fistula are not good. In a meta-analysis published in 2005, the primary failure~     rate of a radiocephalic fistula was 15.3% and the primary and secondary patency rates were~     62.5% and 66.0% at one year. (Rooijens PPGM, Tordoir JHM, Stijnen T, Burgmans JPJ, Smet AAEA~     and Yo TI. Radiocephalic wrist arteriovenous fistula for hemodialysis: meta-analysis~     indicates a high primary failure rate. Eur J Vasc Endovasc Surg 2004; 28, 583-589). Reasons~     for this are multiple but it appears as though the main determinants are the quality of the~     patients veins and the technical skill of the surgeon. Low patency rates are also seen in~     females and those with small veins and arteries. Creating an anastomosis between a small vein~     and artery is technically challenging. This is traditionally preformed with a continuous~     prolene suture. Recently, Medtronic have been marketing the U Clip Anastomotic Device. This~     is a self closing devise which could be called a vascular clip. Reported advantages of this~     clip include better patency rates and faster operations. However, to our knowledge there is~     no randomised evidence to support this with regards to AV fistulas.~      The vascular anastomosis originally developed by Alexis Carrel used interrupted sutures. Over~     time this was replaced by a continuous suture technique which was felt to be quicker and had~     similar patency rates. However, microvascular, paediatric and neurovascular surgeons have~     shown that there are advantages to an interrupted technique. (Hattori H, Killen DA, Green JW.~     Influence of suture material and technic on patency of anastomosed arteries of less than~     1.5mm. Am Surg. 1970; 36: 352 - 354. Cobbett JR. Microvascular surgery. Surg Clin N Am. 1962;~     47: 521.). The reasons for the improved patency with interrupted anastomoses are firstly~     increased anastomotic compliance and flow rate and secondly elimination of the pursestring~     effect and puckering seen with continuous sutures.~      In a prospective but non randomised study to compare interrupted U clips with historical~     published results, the patency rate of coronary anastomoses was 100% at 6 months using the U~     clips compare to a patency rate of 90 -100% in the published series. (Wolf RK, Alderman EL,~     Caskey MP et al. Clinical and six month angiographic evaluation of coronary arterial graft~     interrupted anastomoses by use of a self closing clip device: a multicentre prospective~     clinical trial. J Thorac cardiovasc Surg 2003; 126(1): 168 - 178.)~      Reports from single centres have concluded that the U Clips offer the opportunity to create~     superior interrupted anastomoses for AV fistula, even in patients who would otherwise be~     considered poor candidates for fistula creation. (Ross JR. Creation of native arteriovenous~     fistulas with interrupted anastomoses using a self closing clip device - one clinics~     experience. Journal of vascular Access 2002; 3: 140 - 146). In this report with small~     numbers, the radiocephalic fistulas had an 8 week maturation rate of 93%. Of the 28 patients~     having a radiocephalic fistula, 10 had veins of between 1.0 - 1,5mm diameter.~      The aim of this pilot study will be to assess if there is a clinical difference in the~     maturation rates of autologous AV fistulae when a clipped anastomosis is compared to a~     conventional prolene anastomosis.~   "
208707|NCT00829140|"~     The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and~     food intake in obese and overweight patients.~   "
208708|NCT00829127|"~     The aims of the study are to evaluate the safety, tolerability and pharmacokinetics of~     AZD8075 in healthy male subjects at increasing doses when given for 14 days~   "
208709|NCT00829114|"~     Non-randomized, comparative study (1:1 allocation) to study interactions between~     nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.~   "
208710|NCT00829101|"~     The purpose of the study is to assess if there are any differences in the articulatory and~     phonological competence in pre-school children with unilateral cleft lip and palate (UCLP)~     who are treated with different surgical methods of palatal repair.~   "
208711|NCT00829088|"~     The aim of this study is to get information about absorption, distribution, metabolism and~     excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.~   "
208712|NCT00829075|"~     Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian~     Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long~     protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group~     II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte~     recipients was compared.~   "
208713|NCT00829062|"~     The purpose of the study is to present evidence based literature and clinical data to the~     medical directors at Missouri Medicaid to help modify the existing policy regarding insulin~     pump therapy in pediatric patients with diabetes.~   "
208714|NCT00829049|"~     Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel~     0.3% in treating moderate to severe facial acne vulgaris~   "
208715|NCT00829036|"~     The purpose of the project is to find out what kinds of information are most useful to~     visually impaired people when they are moving around indoors and what kinds of controls will~     make it easy for visually impaired people to control a device to help orient them to an~     unfamiliar indoor space.~   "
208716|NCT00829023|"~     The purpose of the present study was to examine the native bacteria around the shoulder and~     determine the efficacy of three different surgical skin-preparation solutions on the~     eradication of bacteria from the shoulder.~   "
208717|NCT00829010|"~     The purposes of this study:~        -  To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine~          GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed~          uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age~          and following booster vaccination at 9-10 months of age.~        -  To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine~          GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary~          vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with~          or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at~          6 and 14 weeks of age followed by booster vaccination at 9-10 months of age.~        -  This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on~          nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all~          study participants.~   "
208718|NCT00828997|"~     Previous studies have analyzed serological responses following pneumococcal vaccination using~     23-valent vaccination (Pneumovax) in Rheumatoid Arthritis (RA) patients that were on~     different therapeutic modalities including TNF-blockers and methotrexate. The results have~     shown that serological response was significantly reduced in RA patients receiving~     methotrexate compared to those receiving TNF-blockers.~      In contrast when using polypeptide immunisation (influenza vaccine) we found that anti-TNF~     significantly impaired the serological response compared to the methotrexate treated RA~     patients. The aim of this study is to analyze serological responses after Prevenar~     vaccination in patients with chronic arthritis and to study the impact of different treatment~     modalities on serological responses.~      It will be of interest to see if the result is different compared to the one seen after~     immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.~   "
208719|NCT00828984|"~     This randomized phase II trial studies how well macrogol 3350-based oral osmotic laxative~     (polyethylene glycol 3350) works in preventing cancer in patients at risk of colorectal~     cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of~     macrogol 3350-based oral osmotic laxative may stop cancer from growing in patients who are at~     risk of colorectal cancer.~   "
208720|NCT00828971|"~     The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is~     as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment~     of complicated skin and skin structure infection.~   "
208721|NCT00828958|"~     The purpose of this study is to examine the discontinuation rate of schizophrenia patients~     receiving multiple sequential 2 mL injections of long acting injectable risperidone (an~     atypical antipsychotic medication) when administered into the deltoid muscle once every 2~     weeks.~   "
208722|NCT00828945|"~     It is a prospective observational study.~      Patients will be high risk patients (for developing cardiovascular events) that are treated~     with a statin. Patients will be enrolled at a normal clinic visit and provided with a small~     box containing info about the disease, a LDL self-test and two questionnaires. They will test~     themselves for LDL at home between normal clinic visits (normally 12 months interval) and~     note their value. In the end of the study all patients will fill out a questionnaire with~     questions if the tests and info have raised their awareness of the disease as well if their~     motivation to be compliant has increased.~      We want to look at the possibility to put more responsibility for treatment and for reaching~     treatment goals on the patients since there's a big problem with compliance in this group of~     patients.~   "
208730|NCT00828841|"~     This study is testing the investigational drug, cetuximab, in combination with different~     chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug~     combinations looks most promising and should be tested further. The study will also look at~     what side effects may occur.~   "
208731|NCT00828828|"~     The purpose of this study is to determine the efficacy of influenza vaccine (antibody~     response) in patients with sarcoidosis.~   "
208732|NCT00828815|"~     TMC125 is from the class of drugs called non-nucleoside reverse transcriptase inhibitors~     (NNRTIs). NNRTIs work by blocking reverse transcriptase, a protein that HIV needs to make~     more copies of itself. TMC125 is used in the treatment of adults with HIV-1 infection. The~     purpose of this trial is to see if there is any potential interaction (change in the~     effectiveness of the drug) when taking multiple-dose TMC125 and buprenorphine/naloxone~     together. The trial will also assess the short-term safety and tolerability (how well your~     body handles the drug) when TMC125 and buprenorphine/naloxone are taken together.~   "
208733|NCT00828802|"~     The purpose of this study is to find out what dose of lenalidomide is safe to use in~     combination with decitabine when given in people with myelodysplastic syndrome.~   "
208734|NCT00828789|"~     The purpose of this study is to determine the effect of EFV (Efavirenz) and TDF (Tenofovir~     disoproxil fumarate) on the pharmacokinetics of TVR (Telaprevir) and to determine the effect~     of TVR on the pharmacokinetics of EFV and TDF. Pharmacokinetics means how the drug is~     absorbed into the bloodstream, distributed in the body and eliminated from the body.~     Furthermore, the short-term safety and tolerability of giving TVR, EFV and TDF together will~     be evaluated.~   "
208735|NCT00828776|"~     The primary objective of the study was to assess the safety in use of the drug Heparin~     Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche~     Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the~     product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the~     parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of~     hemodialysis.~   "
208736|NCT00828763|"~     Mass balance study to determine the recovery of a single radiolabelled dose of GSK1349572~     from urine and feces~   "
208737|NCT00828750|"~     An open-label, dose-adjustment extension study to evaluate the safety and efficacy of~     eltrombopag for treatment of subjects with ITP who have previously been enrolled in the~     eltrombopag trial TRA108109 (NCT00540423).~   "
208738|NCT00828737|"~     Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging~     (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.~      The administration of contrast agents that contain gadolinium such as Gadovist might increase~     a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in~     patients with renal impairment. This study is to assess the potential risk to develop NSF in~     patients with renal impairment after the administration of Gadovist. Patients who are~     enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the~     referring doctor. After the MRI scan the patient will be included in a two year follow-up~     period to assess if signs or symptoms suggestive of NSF have appeared.~   "
208739|NCT00828724|"~     The purpose of this study is to evaluate the PK properties in fed and fasted men and women.~   "
208740|NCT00828711|"~     The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg~     Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical~     ripening and induction of labor.~   "
208741|NCT00828698|"~     The purpose of this observational study is to find characteristics and risk stratification~     methods for identification of subjects who have increased risk of death, especially sudden~     cardiac death, after acute myocardial infarction.~   "
208742|NCT00828685|"~     The purpose of this study is to compare early return to function in patients treated with~     closed reduction percutaneous pinning and open reduction internal fixation in displaced~     fractures of the distal radius.~      Hypothesis: Wrist range of motion, grip strength and outcome at 2-3 months after injury are~     better in patients treated with open reduction, internal fixation (ORIF) than in patients~     treated with closed reduction percutaneous pinning techniques (CRPP). In addition patients~     treated with ORIF return to work at faster rates.~   "
208743|NCT00828672|"~     Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly~     multinational). Academic, investigator initiated.~      To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM)~     and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment~     of locally advanced rectal cancer, followed by TME (total mesorectal excision).~   "
208744|NCT00828659|"~     The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy~     recreational polydrug users.~   "
208745|NCT00828646|"~     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics,~     and pharmacodynamics following 14-day multiple oral doses BMS-708163 in healthy young male~     Japanese and healthy elderly male and female Japanese subjects~   "
208746|NCT00828633|"~     RATIONALE: Gathering information about prostate cancer, treatment, and quality of life from~     gay men with prostate cancer may help doctors plan the best treatment.~      PURPOSE: This clinical trial is collecting information about health-related quality of life~     from gay men with localized prostate cancer.~   "
208747|NCT00828620|"~     Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose~     (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs~     by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be~     highly sensitive in detecting early response in other tumours. In this study, the~     investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6)~     in outcome prediction.~   "
208765|NCT00828386|"~     This is a randomized, multicenter, phase III trial comparing induction chemotherapy with~     Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to~     concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or~     with lymph node involvement (≥ N1. The main end point is the event free survival.~   "
208782|NCT00828165|"~     This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per~     subject), designed to test the safety of investigational study drug ARRY-300 in healthy~     subjects. Approximately 12 healthy subjects from the US will be enrolled in this study.~   "
208748|NCT00828607|"~     This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose~     noninvasively focal liver masses. This is a multi-center prospective cohort study of 250~     subjects, which will be performed at four institutions in Canada. Subjects with a focal liver~     mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional~     baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed~     on standard ultrasound scanners with contrast specific imaging capability. The contrast agent~     used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a~     dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the~     standard of care in the institution. Anonymized image files from all imaging will be shown~     independently to two readers, blinded to all clinical and demographic data, who will predict~     malignancy and diagnosis.~   "
208749|NCT00828594|"~     Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in~     patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose~     (MTD)~      Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time~     to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to~     sorafenib alone~   "
208750|NCT00828581|"~     The purpose of this study is to evaluate the PK properties of lorcaserin in obese or~     overweight elderly subjects.~   "
208751|NCT00828568|"~     The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%,~     manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M,~     and to show superiority over vehicle in the treatment of AK.~      The secondary objective is to compare the adverse event (AE) profiles of the two creams.~   "
208752|NCT00828555|"~     PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist~     community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable~     diseases.~      SPECIFIC AIMS~        1. Determine the feasibility of implementing a successful vaccination program for~          adolescent and adult women in Ob/Gyn offices by direct assessment of medical personnel &~          office staff on their:~             -  Attitudes towards vaccination of women against preventable diseases~             -  Perceived barriers to implementing a program to vaccinate women in their offices~             -  Ideas on how to overcome barriers to successful program implementation~             -  Current vaccination practices and office-specific administrative processes~        2. Design & implement a program for Ob/Gyns to vaccinate women against human~          papillomavirus, influenza, & pertussis~        3. Determine the effectiveness of the vaccination program based on~             -  Pre- and post-program vaccination rates~             -  Program satisfaction amongst Ob/Gyn providers and office staff~             -  Willingness to continue and possibly extend the program to additional vaccines~        4. Quantify the level of support and resources needed to develop and implement the~          vaccination program~   "
208753|NCT00828542|"~     The purpose of this study to assess the safety of the etonogestrel-releasing subdermal~     implant (Implanon) inserted during the immediate puerperium of healthy women.~   "
208754|NCT00828529|"~     The purpose of this Phase I, open-label, randomized crossover trial is to investigate the~     pharmacokinetic interaction between steady-state lopinavir/ritonavir and single-dose TMC207~     in healthy volunteers.~   "
208755|NCT00828516|"~     RATIONALE: Acupuncture and moxibustion may improve well-being and quality of life in patients~     with lymphedema caused by breast cancer or head, neck, and throat cancer.~      PURPOSE: This clinical trial is studying how well acupuncture given together with moxibustion~     works in improving well-being and quality of life in patients with breast cancer or head,~     neck, and throat cancer who are undergoing standard treatment for lymphedema.~   "
208756|NCT00828503|"~     A prospective, randomized safety and efficacy study of Certican® as add-on therapy against~     CMV disease in renal transplant recipients~      OBJECTIVES:~      Primary Objective:~      To demonstrate efficacy of Certican® as add-on therapy against CMV disease in comparison to~     either valcyte® (valganciclovir) or cymevene® (ganciclovir) alone, evaluated by quantitative~     measurement of CMV-DNA with PCR from the blood (qCMV-PCR)~      Secondary Objectives:~      To assess safety and tolerability of Certican® in patients with CMV- disease To study the~     effects of Certican® treatment on quality of life~   "
208757|NCT00828490|"~     The purpose of the Utah ePRM (electronic Pharmacotherapy Risk Management) project is to~     improve quality and safety of medication use while simultaneously controlling costs and~     detecting fraud and abuse.~   "
208758|NCT00828477|"~     The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac~     following SLT.~   "
208759|NCT00828464|"~     The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol~     propionate foam in subjects with chronic dermatitis.~   "
208760|NCT00828451|"~     This proposal will test the hypothesis that synthesis and catabolism of epidermal growth~     factor (EGF), the genotype of the EGF gene, and the microbiome interact to influence EGF~     expression in infants at risk for necrotizing enterocolitis (NEC).~   "
208761|NCT00828438|"~     The purpose of this study is to evaluate the PK properties of lorcaserin in subjects with end~     stage renal disease (ESRD) who require dialysis and will be studied under dialysis and~     non-dialysis conditions.~   "
208762|NCT00828425|"~     Aim of this NIS is to retrospectively document the management of diabetic patients with~     retinopathy in a naturalistic setting in Switzerland. Following elements are going to be~     analyzed:~        -  which medication are used to keep blood pressure under control?~        -  which medication are used for metabolic control?~        -  the average control level of metabolism and blood pressure is compliant with the~          international guidelines?~        -  laser photocoagulation plays a role in the control of metabolism and blood pressure?~        -  there are differences in the control of metabolism and blood pressure between patients~          with DM I or DM II?~        -  there is an influence of renal failure on the choose of medication?~   "
208763|NCT00828412|"~     This study compares the effectiveness of two topical creams for atopic dermatitis in~     pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice~     daily for 6 weeks or until clear.~   "
208764|NCT00828399|"~     Ionizing radiation has cytotoxic effects, and is commonly used as treatment for neoplasm. A~     common adverse effect of radiation is acute diarrhoea. Glutamine is an aminoacid with~     antioxidant effects that can protect tissues of damage dued to radiation. The investigators~     designed a randomized, double-blind trial phase III to study if glutamine prevents acute~     radiation enteritis.~   "
208766|NCT00828373|"~     Lidocaine is a local anesthetic which is widely used in daily anesthesia and surgical~     practice. It has been shown that intravenous lidocaine given during an operation has~     analgesic properties. Finally intravenous lidocaine is inexpensive and easy to administer and~     safe if non-toxic doses are respected. It is likely that the use of lidocaine infusions~     during anesthesia might increase in the coming years. Neuromuscular blockers (curare like~     substances) are used in anesthesia to facilitate tracheal intubation and to achieve muscle~     relaxation and immobility during surgery. Rocuronium is one of the most widely used~     neuromuscular blocking agents. Local anesthetics, such as lidocaine, are known to potentiate~     the effect of neuromuscular blocking agents. In the study the investigators want to evaluate~     the effect of intravenous lidocaine during the operation on the time course of the~     rocuronium-induced neuromuscular block. A secondary aim is to evaluate intubation conditions~     (lidocaine has been shown also to improve intubation conditions) and safety.~   "
208767|NCT00828360|"~     While cardiac resynchronization therapy (CRT) has a well demonstrated therapeutic effect in~     selected patients with advanced heart failure (HF) on optimized drug therapy, non-responder~     rate remains high. The low-dose dobutamine stress-echo (DSE) test to predict positive~     response to CRT (LODO-CRT) trial is designed to improve patient selection for CRT.~   "
208768|NCT00828347|"~     There are still no established protocols for maintenance therapy with intravenous or oral~     vitamin D preparations after the iPTH target has been achieved.~      Therefore, the present study compared the efficacy of two maintenance therapy protocols,~     i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0~     ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with~     secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the~     control of iPTH to < 150 pg/mL.~   "
208769|NCT00828334|"~     The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA~     Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less~     than 4 mm, and to compare one year safety and efficacy outcomes with recommended OPCs.~   "
208770|NCT00828321|"~     The objective of this study is to compare the rate and extent of absorption of ramipril 10 mg~     capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fasting~     conditions.~   "
208771|NCT00828308|"~     Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.~      Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)~   "
208772|NCT00828295|"~     The objective of the study is to assess the safety and efficacy of two doses of IV~     palonosetron each administered as a single dose for the prevention of postoperative nausea~     and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years~     inclusive undergoing surgical procedures requiring general endotracheal inhalation~     anesthesia.~   "
208773|NCT00828282|"~     The primary aim of this trial is to generate a preliminary analysis of this novel therapeutic~     approach and laboratory studies for patients with recurrent or refractory CLL. Further, this~     pilot trial will demonstrate the feasibility of the translational science methods proposed~     for this new collaboration of investigators. The investigators hypothesize that patients with~     relapsed CLL are recruitable to this study, that the methods for measuring simvastatin~     concentration and target protein translation are feasible, and that the investigators can~     efficiently apply the laboratory research methods to patient blood samples before and after~     patients have taken the study medication.~   "
208774|NCT00828269|"~     The purpose of this study is to evaluate the quality of the RNA and the reproducibility of~     gene expression profiling from liver tissue samples obtained by fine needle aspiration.~   "
208775|NCT00828256|"~     Arthroscopic repair has become the preferable surgical technique to treat rotator cuff tears~     in the last decade. Many researches demonstrate equal and even superior outcome with this~     surgical technique, while others show opposite results.~      The aim of this study is to estimate the anatomic and functional results of the arthroscopic~     repair among the patients of the orthopedic department at the Soroka University Medical~     Center, in order to check the investigators hypothesis that indeed - the arthroscopic repair~     of the rotator cuff is the better surgical technique.~      Methods: study population - 80 patients who had had an arthroscopic repair of the rotator~     cuff between the years 2005-2008 at the SUMC.~      Inclusion criteria: age over 18 years. arthroscopic rotator cuff repair. date of operation~     not before 2005.~      Study design:~        1. Data base Collection.~        2. Inviting the patients for physical examination + ultrasound examination of the operated~          shoulder + filling out questionnaires (SF36, CONSTANT SCORE)~        3. Statistical analysis~        4. Publication~   "
208776|NCT00828243|"~     Inherited deficiencies in any one of 3 genes (surfactant protein B, surfactant protein C, and~     ATP-binding cassette transporter A3) can cause neonatal respiratory distress syndrome by~     disrupting metabolism of the pulmonary surfactant. The investigators will use state of the~     art methods to link specific changes in the genetic code of each of these genes with~     disruption of discrete steps in the metabolism of the pulmonary surfactant in human newborn~     infants. These studies will lead to improved diagnostic capabilities and suggest novel~     strategies to correct surfactant deficiency in newborn infants.~   "
208777|NCT00828230|"~     To proof the superiority of an 8-week rectal treatment with once-daily 2 mg budesonide versus~     placebo for the prevention of acute radiation proctitis, and to evaluate the occurrence of~     chronic radiation proctitis 1 year after start of radiation therapy.~   "
208778|NCT00828217|"~     The aim of this study is to assess the efficacy of adapted physical activity intervention on~     health-related quality of life and satisfaction with care in hospitalized children and~     adolescents.~      This is a randomized controlled study. The hypothesis is that children practicing adapted~     physical activity during their hospitalization present a higher health-related quality of~     life and satisfaction with care than those who do not.~   "
208779|NCT00828204|"~     The primary objective of the study was to evaluate the safe and effective use of the~     single-use autoinjector for the intramuscular (IM) delivery of liquid Avonex® (interferon~     beta-1a) in participants with multiple sclerosis (MS).~   "
208780|NCT00828191|"~     Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy~     and tolerability of a new progesterone formulation to be used for luteal support in IVF~     (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone~     tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.~   "
208783|NCT00828152|"~     Hypochondriasis (health anxiety) is common, has many negative consequences for the afflicted~     individual and is associated with high societal costs. Cognitive Behavioural Therapy (CBT)~     has proven to be effective when administered in live-sessions. The aim of this study is to~     investigate whether CBT remains effective when administered via a self-help programme on the~     Internet.~   "
208784|NCT00828139|"~     This randomized phase II trial is studying topotecan to see how well it works when given with~     or without aflibercept in treating patients with extensive-stage small cell lung cancer.~     Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Combinations of~     biological substances in aflibercept may be able to carry tumor-killing substances directly~     to small cell lung cancer cells. Aflibercept may also stop the growth of small cell lung~     cancer by blocking blood flow to the tumor. It is not yet known whether topotecan is more~     effective with or without aflibercept in treating patients with small cell lung cancer.~   "
208785|NCT00828126|"~     The goal of this clinical research study is to learn how often using a positron emission~     tomography-computed tomography (PET-CT) scan in addition to a standard computed tomography~     (CT) scan will change the surgical plan in patients with metastatic melanoma.~   "
208786|NCT00828113|"~     This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy~     in conjunction with individual counseling for smoking cessation. Adult volunteers in~     generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of~     open-label varenicline therapy. At 12 weeks after their target quit date, they will be~     assigned in a random, double-blind manner to either 40 additional weeks of varenicline or~     placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for~     the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks~     post-treatment.~   "
208787|NCT00828100|"~     The primary objective of this study is to compare the performance of the investigational~     fluid Rapid Influenza Test and the BinaxNOW® Influenza A & B Test in detecting influenza type~     A and influenza type B.~   "
208788|NCT00828087|"~     This study is a prospective, randomized controlled, single blind, two-arm, multi center~     clinical evaluation. A total of 1500 patients will be enrolled in the study.~      Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug~     eluting stent arm. The objective of this study is to assess the safety and performance of the~     Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable~     stent in the setting of primary percutaneous coronary intervention for treatment of patients~     presenting with ST-segment elevation myocardial infarction.~   "
208789|NCT00828074|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving sorafenib together with vinorelbine may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when~     given together with vinorelbine and to see how well they work in treating women with stage IV~     breast cancer.~   "
208790|NCT00828061|"~     This study will investigate whether changes in inflammatory mediators produced by the nose~     after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel~     drugs for the treatment of allergic asthma.~   "
208791|NCT00828048|"~     A centralized web-based database will be used to track patients with IPMN lesions of the~     pancreas to study natural history and risk factors for malignant transformation in this~     multi-center study.~   "
208792|NCT00828035|"~     Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery~     with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant~     (AO group - standard treatment)~      Primary outcome measure : Number of useful hands (light endoscopic robot = one useful~     mechanical hand)~   "
208793|NCT00828022|"~     The objectives of the study are to assess the efficacy and safety of live, attenuated measles~     vaccine as consolidation therapy in patients with measles-positive, non-small cell lung~     cancer with locally-advanced (stage 3B with pleural effusion) or metastatic (stage 4) tumors~     in remission.~   "
208794|NCT00828009|"~     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine~     therapy together with bevacizumab after chemotherapy and radiation therapy may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccine~     together with bevacizumab after chemotherapy and radiation therapy in treating patients with~     newly diagnosed stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by~     surgery.~   "
208795|NCT00827996|"~     The trial is a 12-week phase 2 study. Subjects will be given subcutaneous injections at weeks~     0 (160mg), 2 (80mg), and then every other week (40mg) until week 12 in subjects with moderate~     to severe hidradenitis suppurativa.~   "
208796|NCT00827983|"~     Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of~     luteal support (S.C.) to an approved comparator (vaginal gel).~   "
208797|NCT00827970|"~     30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two~     groups. The intervention group received an invitation to be tested for urogenital Chlamydia~     trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group~     received no intervention (21,000 individuals). Outcome measures: Number of tested~     individuals, number of detected infections, number of women developing PID, ectopic pregnancy~     or infertility, number of women giving birth to a child, number of women receiving IVF~     treatment and number of men developing epididymitis.~      The hypothesis was that more individuals would be tested and treated for infections and that~     number of long term fertility complications would decline in the intervention group compared~     to control group.~   "
208798|NCT00827957|"~     Controlled therapeutic hypothermia is a method of preserving neurological function~     post-resuscitation.It has been associated with improved functional recovery and reduced~     histological deficits in animal models of cardiac arrest.~   "
208800|NCT00827931|"~     Tranexamic acid has been shown to reduce postoperative blood losses and transfusion~     requirements in various types of major surgery (orthopedic surgery, spine surgery,~     cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is~     being conducted to compare the efficacy of tranexamic acid plus standard of care versus~     standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.~   "
208801|NCT00827918|"~     A study to evaluate the safety and efficacy of treatment with MK-8998 as compared to placebo~     and olanzapine for acutely psychotic patients with schizophrenia. The primary hypothesis is~     that in participants undergoing an acute psychotic episode of schizophrenia, MK-8998 6 to 8~     mg twice daily is superior to placebo in the treatment of symptoms of schizophrenia as~     measured by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS)~     total score at Week 4.~   "
208802|NCT00827905|"~     The purpose of this study is to determine whether the respiratory rate provided by the Kai~     Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is as accurate as that provided by~     the Welch Allyn Propaq Encore model 242 and the Embla Embletta system with Universal~     XactTrace respiratory effort sensor and Somnologica for Embletta software.~   "
208803|NCT00827892|"~     Intracerebral hemorrhage (ICH) is a devastating disease with less than 20% of survivors being~     independent at 6 months. There is currently no approved treatment for ICH which has been~     shown to improve outcomes. In an effort to develop a new treatment for ICH, this research~     focuses on a different aspect of ICH treatment which has not yet been evaluated: enhancing~     absorption of the blood clot with medication.~   "
208804|NCT00827879|"~     The purpose of the project is to develop and test a couples-based relationship enhancement~     group intervention for married or partnered Operation Enduring Freedom (OEF)/Operation Iraqi~     Freedom (OIF)/Operation New Dawn (OND) veterans to prevent the perpetration of intimate~     partner aggression (IPA) among participants.~   "
208805|NCT00827866|"~     The proposed study is a two-armed randomized controlled clinical trial examining the~     long-term (one-year) efficacy of telephone intervention conditions for smoking cessation in a~     high risk medical population; namely, cancer survivors: Proactive telephone recruitment~     through the Childhood Cancer Survivors Survey (CCSS) St. Jude Life Study, After Completion of~     Therapy (ACT) Clinic and face to face recruitment at the local West Clinics will serve as the~     primary methods of recruitment.~      The specific aims of the study :~      (1) To recruit nationally a cohort of approximately 1242 smokers who are cancer survivors(621~     childhood cancer survivors and 621 adult cancer survivors); 2) To determine the long-term~     (one year) efficacy of the intervention condition for participants randomly assigned to the~     Counselor-initiated versus a Self-paced QL; and (3) to find out whether treatment outcomes~     vary as a function of survivors' age of cancer diagnosis (survivors who diagnosed while~     adults vs. childhood cancer survivors who diagnosed before the age of 21).~   "
208806|NCT00827853|"~     Despite recent advances in stent technology and its widespread application in the treatment~     of peripheral vascular disease (PVD), incidences of partial or complete blockage of stent~     lumen (in-stent restenosis) due to in growth of cells (neo-intimal proliferation) is~     unacceptably high.~      In diabetics with long superficial femoral artery (SFA) lesions, in-stent restenosis rates~     are higher than in non-diabetics. Consequently interventional techniques that curtail~     in-stent restenosis have to be explored. Cryoplasty is a stent expansion method in which a~     balloon is expanded using pressurized nitrous oxide gas. As the nitrous oxide expands in the~     balloon it cools the surroundings to about -10 degrees C. This induces programed death~     (apoptosis) of the smooth muscle cells in arterial wall.~      The investigators hypothesize that Cryoplasty, by inducing an apoptotic smooth muscle cell~     response, when applied to post-dilation of nitinol self-expanding stents in the Superficial~     Femoral Artery (SFA) of diabetics, would lead to decreased in-stent restenosis due to~     decreased neointimal proliferation.~   "
208807|NCT00827840|"~     Primary objective: To examine whether the switch to paliperidone ER from risperidone improves~     cognitive function in stabilized patients with schizophrenia.~      Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after~     switching to paliperidone ER from risperidone~   "
208808|NCT00827827|"~     Chronically disabled stroke survivors experience accelerated skeletal muscle atrophy and~     other detrimental changes to muscle and surrounding tissues on the paretic side. This~     unilateral tissue-level damage contributes to worsening disability and insulin resistance.~     This VA Merit Award will advance the investigators' understanding of the potential for~     strength training (ST) to reverse stroke-related muscle abnormalities to improve metabolic~     health, strength, and function. It will be the first study to thoroughly investigate the~     effects of ST on muscle atrophy, intramuscular fat, muscle fiber characteristics, capillary~     density and insulin sensitivity after stroke.~   "
208809|NCT00827814|"~     Increased bladder mass occurs as a consequence of bladder outlet obstruction in animals and~     patients, and relief of bladder outlet obstruction reverses an increased bladder mass.~     Whether increased bladder mass is not only a consequence of bladder outlet obstruction but~     also a relevant risk factor for the progression of lower urinary tract symptoms associated~     with benign prostate hyperplasia cannot be decided due to a lack of appropriate data, most~     likely because bladder wall thickness is not routinely measured in clinical studies and/or~     routine clinical practice. Despite this lack of data, many urologists feel that increased~     bladder mass should be prevented or decreased to reduce the occurrence of serious~     complications.~      The possibility of using bladder wall thickness data as criteria for benign prostate~     hyperplasia intervention and as outcome criteria for benign prostate hyperplasia treatment~     has been proposed. Detrusor hypertrophy associated with bladder outlet obstruction can be~     imaged on suprapubic ultrasound, and bladder mass can be quantified from the evaluation of~     bladder wall thickness and bladder volume. Bladder wall hypertrophy has been found to be~     correlated with detrusor function.~      Independent studies have shown that surgical treatment of benign prostatic obstruction~     results in a significant decrease of bladder mass. Preliminary data suggest the possibility~     that medical treatment with alpha-adrenergic antagonists might also produce a reduction of~     bladder wall hypertrophy.~      The investigators assume that the prevention of benign prostate hyperplasia progression by~     alpha-adrenergic antagonists and 5 alpha reductase inhibitors may be result of bladder~     function protection. To our knowledge there have been no studies that evaluated the effects~     of a 5 alpha reductase inhibitors on bladder function. Therefore, the investigators plan to~     conduct a prospective trial evaluating the effects of 5 alpha reductase inhibitors on bladder~     function by the evaluation of bladder wall thickness and lower urinary tract symptoms.~   "
208824|NCT00827619|"~     This study is intended to evaluate the long-term effectiveness of treatment of de novo or~     restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™~     Vascular Stent which has received the CE mark for commercial use. The study is designed as a~     single arm non-randomized post-approval study.~   "
208825|NCT00827606|"~     The purpose of this study is to characterize three year descriptive growth and development~     (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in~     pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin~     treatment.~   "
208810|NCT00827801|"~     Primary Objective:~      To determine if there is a reduction in the mean symptom severity scores for the heart~     failure specific symptom items between baseline and at the end of three months between~     patients whose symptoms are managed using the MDASI-HF symptom assessment scores (treatment~     group) as a decision making guide, as compared to patients managed without using the MDASI-HF~     symptom assessment scores (control group).~      Secondary Objectives:~        1. Examine the correlation between mean symptom severity scores and the secondary endpoints~          of: a) exercise tolerance ( 6-minute walk), b) NYHA (New York Heart Association)~          functional classification, c) B-type natriuretic peptide (a biomarker for heart~          failure), and d) dose titration of HF (heart failure) medications.~        2. Define symptom severity critical values in cancer patients with concurrent heart failure~          that trigger clinical intervention~        3. Identify symptom clusters which may occur in cancer patients with concurrent heart~          failure.~   "
208811|NCT00827788|"~     The purpose of this study is to determine the incidence of contrast induced nephropathy and~     myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide~     administration in patients with acute myocardial infarction undergoing primary PCI.~   "
208812|NCT00827775|"~     1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis~          patients if blood pressure elevations with hemodialysis are associated with decreased~          endothelial cell function (measured by brachial artery flow mediated dilation and~          endothelial progenitor cell number), both of which are novel mechanistic markers in the~          causal pathway for detrimental cardiovascular outcomes; and~        2. To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood~          pressure elevations with hemodialysis can improve endothelial cell dysfunction as a~          surrogate mechanistic marker for improving cardiovascular outcomes.~   "
208813|NCT00827762|"~     The purpose of this study is to determine whether improvements in behavior occur in children~     with phenylketonuria (PKU) who are taking Kuvan.~   "
208814|NCT00827749|"~     The purpose of this study is to evaluate the efficiency of a novel non-invasive method for~     swallowing disorders detection in geriatrics.~   "
208815|NCT00827736|"~     The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared~     to a relatively new treatment (injection of Botox in the internal anal sphincter). The study~     hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison~     is done blinded for the surgeon and the patient.~   "
208816|NCT00827723|"~     The aim of the investigators' study is to elucidate the relationship between a functional~     liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with~     impaired liver function from alcoholic and non-alcoholic aetiologies. Alcoholic and viral~     cirrhosis present important differences in terms of cellular mechanisms responsible for the~     disease progression with a distinct and unique gene expression pattern that regulates the~     type of inflammatory response. These differences probably influence the hepatic functional~     reserve and the onset of portal hypertension at a comparable clinical and biological level of~     derangement and the investigators may expect significant differences in the recovery from~     hepatectomy.~      The investigators' hypothesis is that at a comparable ICGR-15 rate non-viral cirrhotic liver~     presents higher portal pressure values and the investigators also argue that alcoholic~     cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.~   "
208817|NCT00827710|"~     Can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care~     distribution of report cards to patients and 3) provider performance feedback with patient~     level data?~   "
208818|NCT00827697|"~     Our hypothesis is that nucleic acid amplification testing (NAAT) with the APTIMA Combo2 (AC2)~     will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal~     samples. We also hypothesize that AC2 will be equivalent to NAAT with the Becton Dickinson~     ProbeTec in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.~   "
208819|NCT00827684|"~     The purpose of this study is to investigate the safety and efficacy of temsirolimus as a~     single drug, and of temsirolimus in combination with irinotecan in chemotherapy resistant~     patients with KRAS mutated colorectal cancer.~   "
208820|NCT00827671|"~     The purpose of this study is to determine whether the addition of the combination between~     cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is~     safe and adds efficacy.~   "
208821|NCT00827658|"~     Ulnar nerve blockade is necessary for sensory anesthesia and analgesia in the hand during~     minor procedures. The course of the ulnar nerve in the forearm, wrist, and hand is~     predictable and has low variability. However even with known anatomic location and landmarks,~     ulnar nerve blocks at the wrist frequently are inadequate for procedural anesthesia. The~     antebrachial fascia at the wrist acts as a barrier to local infiltration. Since the fascia~     can not be visualized or palpated, it is commonly not penetrated, resulting in an inadequate~     block. Furthermore at the level of the wrist the ulnar artery lies in close proximity to the~     nerve and there is potential for arterial puncture while attempting injection for volar wrist~     block. The palmar ulnar nerve block is an injection distal to the hook of the hamate in the~     thenar eminence which avoids the ulnar artery and antebrachial fascia. This block has been~     used successfully for many years in clinical practice but has not been assessed or compared~     in a research study. The purpose of this study is to assess the validity of using a palmar~     ulnar nerve block for procedures in the hand as compared to the standard volar wrist ulnar~     nerve block.~   "
208822|NCT00827645|"~     The objective of this study is to determine whether women who are already receiving treatment~     for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual~     dysfunction as well.~   "
208823|NCT00827632|"~     There is a large gap between lowest expected failure rates of about 1.5% and typical use~     failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral~     contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC~     failure among heavier women, particularly those using the lowest doses. The prevalence of~     obesity in the US population has recently increased to about 23% in women aged 20-29, peak~     years for OC use. OC physiology and effectiveness have not been evaluated in obese women. We~     propose a double blind randomized clinical trial to include normal weight and obese women who~     have normal ovulatory function at baseline; we will randomize women to 2 widely used OCs and~     evaluate ovarian follicle development and circulating progesterone to assess ovarian~     suppression during OC use.~   "
208826|NCT00827593|"~     The purpose of this study is to examine the effectiveness of 3 behavioral weight loss~     programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined~     approach which includes university-based treatment followed by Weight Watchers.~   "
208827|NCT00827580|"~     A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS)~     following capecitabine (Xeloda).~   "
208828|NCT00827567|"~     The hypothesis of this clinical research study is to discover if the study drug RAD001 can~     shrink or slow the growth of Estrogen Receptor/Progesterone Receptor (ER/PR) negative or~     Human Epidermal growth factor Receptor 2 (Her2 Neu) negative breast cancer. The safety of~     RAD001 will also be studied. Patients physical state, symptoms, changes in the size of the~     tumor, and laboratory findings obtained while on-study will help the research team decide if~     RAD001 is safe and effective.~   "
208829|NCT00827554|"~     Hepatocellular carcinoma (HCC) is a major tumor type worldwide, especially in China as the~     sequence of hepatitis B and liver cirrhosis. Activation of the coagulation system occurs~     commonly in patients with malignancy. Several studies have suggested that anticoagulant~     therapy may improve survival in patients with malignancy. The low molecular weight heparins~     (LMWHs) lend themselves to such studies because of their effects in experimental models of~     malignancy and the relative ease of administration compared with unfractionated heparin. The~     purpose of the present RCT was to determine whether addition of LMWH to transarterial~     chemoembolization (TACE) would improve HCC patient outcome compared with TACE alone.~   "
208830|NCT00827541|"~     This is a study to evaluate the safety of tigecycline in patients with complicated~     intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI)~     under real practice in the usual hospital setting and patients' conditions, in order to~     assess the real incidence of adverse events related with tigecycline in these patients.~   "
208831|NCT00827528|"~     The objective of this study is to evaluate surgical treatment of anterior vaginal wall~     prolapse using the sis graft or traditional repair. This a randomized and prospective study.~     Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in~     quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with~     FSFI and possible complications.~   "
208832|NCT00827515|"~     Initial studies have used a powder in capsule formulation of PH797804. In future studies an~     immediate release tablet will be used. The purpose of this study is to compare blood levels~     of PH797804 following an oral dose of the powder in capsule formulation and the tablet~     formulation. In addition the effect of food blood levels of PH797804 will be investigated~   "
208833|NCT00827502|"~     To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract~     Infections (URTIs).~   "
208834|NCT00827489|"~     The purpose of this study is to assess the safety and tolerability of ascending single oral~     doses of HTC-867 in healthy young and elderly subjects. This study will also evaluate the way~     the drug enters and leaves the blood and tissues over time and how the drug acts on and in~     the body in a fasted and fed state.~   "
208835|NCT00827476|"~     we will perform xenotransplantation and in vitro culture of ovarian tissue from patients~     undergoing ovarian cortex cryopreservation.~   "
208836|NCT00827463|"~     Estimate the efficiency of a strategy of premature screening of the maternal anaemia during~     the first quarter of pregnancy versus the usual strategy of screening of the anaemia during~     the sixth month.~   "
208837|NCT00827450|"~     This study will assess~        -  whether coffee consumption protects against fructose-induced hepatic steatosis in~          healthy humans~        -  whether the protective effect of coffee is dependent on it's antioxidant composition~   "
208838|NCT00827437|"~     The primary aim of this single site study was to assess the feasibility of implementing a~     staff/parent communication intervention within 72 hours of the parents making an end-of-life~     decision on behalf of their child.~   "
208839|NCT00827424|"~     Scientific background:~      Obesity is a known risk factor for cardiovascular disease, metabolic syndrome, and diabetes.~     In Israel, the prevalence of obesity and diabetes among Arab females is 2 and 2.8 times~     higher than Jewish females, respectively. The economic impact of obesity and overweight in~     terms of illness, disease and lost productivity is estimated to amount to 2-9% of the~     national health budget in countries with high GDP. Diabetics have medical expenditure that is~     2.4 times higher than non diabetics per capita.~      Lifestyle modification is an effective tool in reducing morbidity and health care expenditure~     but despite that most family practitioners usually treat the complications of obesity rather~     than preventing it.~      PACE is a comprehensive health promotion guide in counseling patients to an active healthy~     lifestyle. PACE is designed to assist the primary health care providers to promote physical~     activity and dietary changes during routine office visits.~      Objectives:~      To asses the impact of PACE program on increasing the amount of physical activity, improving~     clinical and metabolic indices, increasing the documentation of lifestyle indices in the~     medical records and reducing health care expenditure and utilization.~      Working hypothesis:~      Implementing a modified PACE protocol can achieve this objectives in Arab women.~      Methodology:~      The investigators will conduct a structured, multidisciplinary and continuous primary care~     based intervention, assisted by trained health promoters and applying a locally adjusted PACE~     protocol.~   "
208840|NCT00827411|"~     Our first hypothesis is that dose adjustment of aspirin and clopidogrel based on biological~     monitoring reduces the rate of severe cardiovascular complications compared to a conventional~     strategy in patients scheduled for drug eluting stent implantation and followed up for one~     year. Our second hypothesis is that interruption of clopidogrel / Prasugrel after one year of~     a combined therapy of clopidogrel/Prasugrel and aspirin is associated with a higher rate of~     severe cardiovascular complications as compared with patients in whom aspirin and clopidogrel~     / Prasugrel is maintained during the subsequent 6 months of follow-up.~   "
208859|NCT00827164|"~     The purpose of this feasibility study is to examine the effect of resistance training on~     muscle strength, lean body mass, physical functioning, fatigue, and quality of life in head~     and neck cancer patients receiving radiation therapy.~   "
208877|NCT00826930|"~     The purpose of this study is to evaluate the impact of Trans Sodium Crocetinate (TSC) on~     oxygen levels in brain tumor tissue in patients with high grade glioma. The proposed clinical~     indication for TSC is a radiation sensitizer for the treatment of cancerous tumors.~   "
208841|NCT00827398|"~     For numerous malignant diseases allogeneic hematopoietic stem cell transplantation (HSCT) is~     the only curative therapy. One of the major complications is the occurrence of acute~     graft-versus-host-disease (aGVHD). Thirty to eighty percent of patients after HSCT develop~     aGVHD despite the prophylactic application of different immunosuppressive drugs.~      The response rates to the conventional first line treatment are only 15-35%4. In case of a~     steroid refractory aGVHD different therapeutic strategies have been evaluated, but with no~     satisfactory results so far. The mortality of patients suffering from steroid refractory~     aGVHD remains at 75-80%. Therefore, it remains important to search for new therapeutical~     strategies for the treatment of aGVHD.~   "
208842|NCT00827385|"~     The purpose of this study is to prospectively determine the association between incidence of~     neurological morbidity and minimum fractional blood pressure reached during laminectomy~     procedures under general anesthesia in hypertensive and normotensive subjects 40 years old~     and older.~   "
208843|NCT00827372|"~     The major purpose of this study is to determine if a new drug called pazopanib decreases~     lymphedema in subjects previously treated for cancer. Lymphedema, or swelling of the arm, is~     a result of damage to the lymphatic vessels in the arm during surgery and/or radiation. The~     damaged vessels can not adequately drain fluid from the arm, resulting in increased pressure~     and swelling. Pazopanib has not previously been studied as a treatment for lymphedema.~   "
208844|NCT00827359|"~     The purpose of this study is to determine if certain features of tumor specimens sampled~     prior to therapy can predict for the likelihood of responding to everolimus.~   "
208845|NCT00827346|"~     Platelets are a major component of clot formation which can lead to clotting events such as~     heart attack. During treatment for a heart attack, doctors try to remove this blockage as~     quickly as possible so that the heart can recover and start to work properly again. The~     standard of care at the Heart Institute for patients having a heart attack is a procedure~     called a Percutaneous Coronary Angioplasty. A drug called Clopidogrel (Plavix) is routinely~     used prior to the angioplasty to prevent blood clots. Patients usually remain on Clopidogrel~     for at least one year following the angioplasty. Clopidogrel works by preventing the blood~     from forming sticky substances called platelets, which clump together to form clots. Despite~     the routine use of Clopidogrel, some patients still return to the hospital with another heart~     attack, or with more chest pain. There is a growing body of evidence that recurrence of these~     complications may be attributed to some patients having a poor response to Clopidogrel.~      This pilot study will examine how platelets react to different doses of Clopidogrel given to~     patients having a heart attack.~   "
208846|NCT00827333|"~     RATIONALE: Palliative care teaching sessions may be more effective than standard care in~     improving caregiver burden, caregiver skills preparedness, quality of life, and distress in~     family caregivers of patients with non-small cell lung cancer.~      PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in~     family caregivers of patients with non-small cell lung cancer.~   "
208847|NCT00827320|"~     The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets~     under fed conditions~   "
208848|NCT00827307|"~     The purpose of this study is to compare Zoladex plus tamoxifen with tamoxifen alone as~     adjuvant hormonal therapy in pre- or perimenopausal women with early-stage breast cancer in~     terms of breast density, estrogen levels, lipidemia, endometrial thickness and~     ultrasonographic abnormalities.~   "
208849|NCT00827294|"~     The goals of the study are to determine whether self-delivered, home-based mirror therapy~     decreases the frequency and intensity of phantom limb pain and improves mood and physical~     function in persons with phantom limb pain.~      The investigators hypothesize that self-delivered home-based mirror therapy will~     significantly decrease phantom pain intensity, will improve mood, and will improve function~     at one-month follow-up.~   "
208850|NCT00827281|"~     This study examines whether isolated doses of D-cycloserine enhance the efficacy of CBT for~     smoking cessation.~   "
208851|NCT00827268|"~     This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have~     poor reading skills following a stroke. Specifically, this study is designed to improve skill~     in sounding out words for reading and spelling. The overall time commitment for participation~     in this study is approximately 11-30 weeks.~   "
208852|NCT00827255|"~     The objective of this retrospective chart review is to evaluate the patient characteristics,~     treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05%~     therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic~     Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.~   "
208853|NCT00827242|"~     The purpose of this study is to determine whether an experimental drug known as tadalafil~     given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia~     (straining, urinary frequency, feeling like your bladder is still full, etc.)~   "
208854|NCT00827229|"~     A clinical study was conducted to demonstrate the accuracy of the LaborPro System in~     measuring fetal head station (from the pelvic inlet), cervical dilatation, and fetal head~     position against manual/digital examination. The LaborPro obtained device values was compared~     to measurements gathered within 15 minutes by manual/digital examination performed by two~     independent physicians. The study was a non significant risk (NSR) device study.~   "
208855|NCT00827216|"~     In this study the investigators want to investigate the effect of a short intravenous~     infusion of Erythromycine on gastric emptying on patients considered full stomac and~     scheduled for Emergency operation. A gastroscopy will be done after intubation to controll~     the effect of the perfusion.~   "
208856|NCT00827203|"~     The aim of this study is to determine the safety and tolerability of elesclomol sodium at~     escalating doses (ultimately identifying the maximum tolerated dose). This study will also~     characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in~     advanced solid tumors that are metastatic and unresectable.~   "
208857|NCT00827190|"~     This is a first-in-human study of ILS-920. This study will provide an initial assessment of~     the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ILS-920 after~     administration of ascending single intravenous (IV) doses to healthy adult subjects.~   "
208858|NCT00827177|"~     This is an open-label, dose-escalation study of ARQ 197 administered orally in combination~     with sorafenib.~   "
208860|NCT00827151|"~     The adolescent and young adult years are a critical window in time for bone mineral accrual.~     More than 90% of peak bone mass is achieved by 18 years, and data indicate that insults~     sustained during adolescence and young adulthood may result in permanent deficits in bone~     accrual. Adult athletes with amenorrhea (AA) have low bone mineral density (BMD) secondary to~     hypogonadism, associated with increased fracture risk and associated co-morbidities. We will~     examine whether estrogen replacement will increase BMD and improve measures of bone~     microarchitecture in adolescents and young women with AA, thus optimizing peak bone mass.~   "
208861|NCT00827138|"~     Rationale: DCC-2036 is a potent broad spectrum inhibitor of BCR-ABL kinase. Inhibition of~     BCR-ABL has been validated for effective treatment of chronic myeloid leukemia (CML). The~     emergence of mutant forms of BCR-ABL which resist inhibition by imatinib, dasatinib, and~     nilotinib is associated with loss of efficacy in treatment of the disease. DCC-2036 is a~     potent inhibitor of resistant mutants of BCR-ABL including the T315I mutation, and would~     therefore be expected to effectively treat patients who fail to respond to other BCR-ABL~     inhibitors. DCC-2036 also inhibits FLT3-ITD, TIE2, KDR, LYN and TRKA kinases. Purpose: to~     assess the safety and tolerability in patients after continuous administration of DCC-2036~     and to determine recommended doses for the conduct of a Phase 2 efficacy trial.~   "
208862|NCT00827125|"~     The purpose of this study is to establish normograms of parameters measured by the LaborPro~     system. To test the prediction of these parameters on labor progress and mode of delivery.~   "
208863|NCT00827112|"~     This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted~     atazanavir can be expected to be safe and efficacious in treatment naive HIV infected~     patients. Based on the results from this study, a confirmatory phase 3 study may be~     conducted.~   "
208864|NCT00827099|"~     RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant~     helps stop the growth of cancer cells. It may also stop the patient's immune system from~     rejecting the donor's stem cells. The donated stem cells may replace the patient's immune~     cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from~     happening.~      PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant~     together with fludarabine, melphalan, and antithymocyte globulin works in treating patients~     with hematologic cancer.~   "
208865|NCT00827086|"~     Environmental factors possibly influencing uveitis are evaluated.~   "
208866|NCT00827073|"~     The purpose of this study is to determine if there is a difference on the penetration of~     betadine 5% when using lidocaine 2% jelly versus topical tetracaine 0.5% in topical cataract~     surgery. This will be assessed comparing bacterial colony count and species by taking swabs~     from the eye surface before and after the topical anesthesia has been administered.~   "
208867|NCT00827060|"~     Observation of the initial Procalcitonin values and the clinical course of consecutively~     included patients with Acute Respiratory Tract Infections at general medical practices in~     greater Hannover.~   "
208868|NCT00827047|"~     Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver~     ipsilateral to the lesion that requires resection from the systemic circulation,has the~     advantage of preventing backflow hemorrhage or air embolism without having to resort to caval~     blood flow interruption of THVE.This study is to evaluate if THHVE can raduce bleeding,reduce~     the incidence of complications and improve the patient's free survival and overall survival~     compared with hemihepatic vascular clamping and Pringle maneuver.~   "
208869|NCT00827034|"~     This study will evaluate the potential drug-drug interaction of Dimebon with the~     FDA-recommended CYP2C9 substrate warfarin in healthy subjects. Conformance with the guidance~     includes general study design using a randomized, open label, single-dose warfarin,~     steady-state Dimebon, 2-sequence, 2-treatment, 2-period crossover design with a minimum 7-day~     washout period between treatments.~   "
208870|NCT00827021|"~     Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life~     in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are~     the most used treatment option.~      The purpose of this study is~        1. the evaluation of biochemical markers to determine the efficacy of individual prediction~          of ESAs therapy~        2. to determine the benefits and harms of different ESA doses therapeutic strategy for the~          management of anaemia of end stage kidney disease (ESKD).~   "
208871|NCT00827008|"~     The purpose of this study is to investigate the long-term safety and tolerability and~     efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a~     completed double-blind randomized placebo controlled study~   "
208872|NCT00826995|"~     The purpose of this study is to compare the effect of video-based patient education with~     written instruction on subjects' understanding of melanoma.~   "
208873|NCT00826982|"~     The major goal of this project is to reduce unnecessary pancreatic resections, namely~     resection in those patients with non-regional lymph node metastatses that cannot be cured~     with surgical resection. By combined minimally invasive methods for non-surgical biopsy and~     highly sensitive molecular assays for cancer cells, we believe we can increase the ability to~     detect distant lymph node metastases prior to surgical resection, and direct those patients~     for more appropriate therapy (including possible neo-adjuvant chemotherapy with or without~     surgery). We hypothesize that the combination of EUS-FNA and polymerase chain reaction (PCR)~     of a multimarker panel will increase the sensitivity for malignant lymph nodes compared with~     EUS-FNA cytology in patients with pancreatic ductal adenocarcinoma.~   "
208874|NCT00826969|"~     The study objective is to investigate in a placebo-controlled, double-blind manner the effect~     of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15~     mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or~     placebo will be inhaled once daily. The study duration consists of a treatment period of 4~     weeks. The study will provide further data on safety of ciclesonide.~   "
208875|NCT00826956|"~     To investigate the changes of regional pulmonary blood flow in nondependent lung by~     transesophageal echocardiography during one lung ventilation~   "
208876|NCT00826943|"~     The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine~     (xyzal), and placebo differ in the degree of sedation they produce and their relief of~     allergy symptoms.~   "
208878|NCT00826917|"~     Volumetry measurements can be a potential clinical use as non-invasive tools in prenatal~     diagnosis and screening and helps to reduce the risk and complications of invasive~     procedures. 3DUS volumetry gives more precise results than 2DUS volumetry measurements,~     particularly, of irregularly shaped objects.~   "
208879|NCT00826904|"~     The purpose of this study is to determine whether unrecognized maternal hyperglycemia and~     postprandial lipemia early or late in gestation predicts excess neonatal adiposity.~   "
208880|NCT00826891|"~     This is a single arm, open-label study in women from China who have Advanced (stage IVB)~     Recurrent or Persistent cervical cancer to ⑴assess the response rate (i.e., CR + PR) of~     Cisplatin combined with Topotecan in treatment of advanced (stage IVB) recurrent or~     persistent Cervical cancer; ⑵assess the toxicities of CT regimen in treatment of cervical~     cancer. Prior to treatment, written informed consent should be obtained from all patients.~     Eligible patients will be assigned to CT regimen. The CT regimen is topotecan 0.75 mg/m2 IV~     during 30minutes days 1, 2, and 3; followed by cisplatin 50 mg/m2 IV on day1, repeated every~     21 days. The study will consist of two phases: the safety run-in phase and study phase.~   "
208881|NCT00826878|"~     This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety,~     tolerability, and maximum tolerated dose of tivozanib (AV-951) with this dosing schedule, as~     well as overall response rate of tivozanib (AV-951) administration in NSCLC.~   "
208882|NCT00826865|"~     The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets~     under fasted conditions~   "
208883|NCT00826852|"~     The purpose of this study is:~        -  to assess the efficacy of the combination in terms of Objective (clinical and~          radiological) Response Rate~        -  to assess the time to progression of the disease; assess the safety profile of the~          combination, and assess the survival time.~   "
208884|NCT00826839|"~     Hundreds of thousands of couples in the United States experience infertility each year. When~     initial measures do not help, some couples require a process called ovarian stimulation and~     in vitro fertilization (IVF). Usually, a woman produces at most one egg each month. Ovarian~     stimulation helps these women make more than one egg per month. However, this involves taking~     hormones that stimulate the ovary to produce many eggs at one time. The stimulatory hormones~     injected with a small needle. The eggs are removed from the ovary through a surgical~     procedure and then placed in a dish for fertilization by sperm to form embryos. The embryos~     are grown in the laboratory then replaced into the woman's uterus 3-5 days later.~      The stimulation of the ovaries is important. Some patients undergo ovarian stimulation for~     IVF but do not respond to the treatment. This is a very difficult situation because even~     though several ovarian stimulation protocols have been used for poor responder patients, it~     is not clear which protocol works best. In fact, two of the most commonly used protocols have~     not been directly compared.~      This study will randomize (like flipping a coin) couples with a history of low response who~     are going to start IVF treatment into two groups. In one group the female partner will use a~     protocol called E2 patch/antagonist. These women will use an estrogen patch and injected~     antagonist for several days before starting injectable fertility medications. The other group~     will use a protocol called OCP/microdose. This group of women will use oral contraceptive~     pills (OCPs) and small doses of lupron along with the other injectable fertility medications.~     We will then follow their progress to see how many eggs they produce and how many women get~     pregnant.~   "
208885|NCT00826826|"~     The purpose of this study is to examine the overall effectiveness of short-time~     anti-arrhythmic drug treatment with amiodarone (to control heart rhythm) to prevent short-and~     long-term atrial fibrillation following an ablation procedure for atrial fibrillation.~   "
208886|NCT00826813|"~     More than half of patients with esophageal cancer are inoperable because of late stage cancer~     or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom~     of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the~     quality of life of such patients, stent placement has been widely accepted to be an option~     for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a~     challenge after stent placement. To combine the advantages of the immediate relief of the~     esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a~     novel esophageal stent loaded with 125I seeds has been developed in the authors' institute.~     The preliminary clinical trial in a single institute has demonstrated better results than the~     conventional stent. This prospective multiple center trial is designed to further demonstrate~     the clinical outcomes with this irradiation, stent in patients compared to those using a~     conventional covered stent.~   "
208887|NCT00826800|"~     The purpose of this study is to see if giving chemo-therapy for colon cancer before surgery~     can shrink the cancer and lead to a higher rate of cure than operating first and then giving~     chemotherapy. Standard treatment for colon cancer is to first operate, and then, if the tumor~     is advanced, give chemotherapy for about 6 months. However, surgery delays the time until~     chemotherapy can start, since the body needs time to heal from the operation. During this~     time any cancer cells that remain in the body that were not removed by the operation may be~     allowed to grow. Giving chemotherapy first could attack the cancer cells right from the~     start, not only at the tumor site that we know of, but also at the site of any cancer cells~     that may have spread to other parts of the body. Another possible reason why giving chemo~     therapy first might work better is that the blood vessels that feed the cancer cells are~     intact before surgery and thus chemotherapy can travel directly to the cancer.~      This study will also use the drug bevacizumab, in addition to the standard chemotherapy.~     Bevacizumab has been on the market since 2004 for colon cancer that has spread to other~     organs, but its use in earlier stage colon cancer, as planned in this trial, is still under~     study.~   "
208888|NCT00826787|"~     The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets~     under fed conditions~   "
208889|NCT00826774|"~     The purpose of the study is to compare three methods of achieving weight loss in primary care~     medical practice. The study will be conducted in six primary care practices. Weight~     management will be provided to a total of 390 obese patients (who have 2 or more components~     of the metabolic syndrome) by their own primary care providers, in conjunction with the~     practices' auxiliary health professionals, including medical assistants.~   "
227242|NCT00583050|"~     The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the~     exclusion of abdominal aortic and thoracoabdominal aneurysms.~   "
208890|NCT00826761|"~     The aim of the ProSat study is to examine the effects of a probiotic capsule containing one~     of two doses (low and high dose) of Lb. Casei on subjective appetite sensation, ad libitum~     energy intake, and appetite hormone response in a single meal test and to determine whether~     the acute effects persist after daily supplementation of the probiotic capsule.~   "
208891|NCT00826748|"~     The purpose of this study is to assess the effect of inhaled beclomethasone (an inhaled~     corticosteroid) on the pattern of the lung airway epithelium and alveolar macrophages gene~     expression of healthy smokers. We hypothesize that the administration of beclomethasone will~     result in reversibility of some of the airway epithelium and alveolar macrophage gene~     expression changes induced by cigarette smoking.~   "
208892|NCT00826735|"~     The purpose of this study was to evaluate the effect of guided imagery on the third stage of~     labor. Blood loss from hemorrhage during childbirth, most commonly due to uterine atony, is~     one of the leading causes of maternal mortality in the United States and the leading cause of~     maternal death worldwide. The hypothesis was that the use of physiologic guided imagery would~     reduce the amount of bleeding during the third stage of labor.~   "
208893|NCT00826722|"~     The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets~     under fasted conditions~   "
208894|NCT00826709|"~     The primary objective of this study is to evaluate the fluID Rapid Influenza Test's ability~     in detecting influenza A and influenza B from individuals presenting with signs and symptoms~     of influenza-like illness (ILI).~   "
208895|NCT00826696|"~     This retrospective review will will attempt to determine whether our data show a significant~     difference in number of deliveries of women with pre-eclampsia compared to deliveries without~     pre-eclampsia during certain months of the year.~   "
208896|NCT00826683|"~     Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and~     tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor~     proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and~     differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in~     NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic~     chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from~     patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an~     inflammatory disease.~   "
208897|NCT00826670|"~     Multidrug-resistant Enterobacteriaceae producing extended-spectrum β-lactamases (hereafter~     called ESBLs) have emerged as an important cause of bloodstream infection in hospitalized~     patients and urinary tract infections in the community. As is the case with other~     multidrug-resistant organisms chronic colonization is frequent, in the case of ESBLs mostly~     intestinal and urinary carriage.~      To the investigators knowledge no randomized, placebo-controlled clinical trial has been~     performed to study the efficacy of a systematic ESBL eradication strategy. Eradication of~     ESBL carriage would cause benefits for the individual patient - by reducing the risk of~     infection - and for the community - by reducing transmission. Even if eradication turns out~     to be impossible, transient suppression of ESBL might reduce the likelihood of transmission~     and thus still be beneficial from an ecologic perspective.~      The purpose of the proposed study is to test the hypothesis that the administration of a 10~     day course of oral antibiotics active against ESBLs can lead to decolonization of ESBL~     carriage in hospitalized patients.~   "
208898|NCT00826657|"~     We hope to learn the clinical and functional signs of sub-clinical vitamin B12 deficiency and~     its response to supplementation in non-anemic, non-pregnant, and non-lactating women in Rural~     Mexico. Vitamin B12 is important in hematopoiesis, neuro-cognitive functions and genetic~     integrity. However vitamin B12 is only found in animal source foods therefore a large segment~     of the population in developing countries and those practicing vegetarianism are at risk of~     deficiency of the vitamin. This information will help decide weather supplementation with~     vitamin B12 is necessary in such populations for public health reasons.~   "
208899|NCT00826644|"~     Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin~     derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators~     will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus~     Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung~     cancer.~      Primary endpoints~        -  to assess Response Rate~      Secondary endpoints~        -  to assess Overall response duration, Time to progression, Overall survival~   "
208900|NCT00826631|"~     Objective: To study the effect of fast food-based hyper-alimentation on liver enzymes and~     hepatic triglyceride content (HTGC)and metabolism.~      Design: Prospective interventional study with parallel control group. Setting University~     Hospital of Linköping, Sweden. Participants: 12 healthy men and six healthy women with a mean~     (SD) age of 26 (6.6) years and a matched control group.~      Intervention: Subjects in the intervention group aimed for a body weight increase of 5-15% by~     eating at least two fast food-based meals a day with the goal to double the regular caloric~     intake in combination with adoption of a sedentary lifestyle for four weeks.~      Main outcome measures: Weekly changes of serum aminotransferases and HTGC measured by proton~     nuclear magnetic resonance-spectroscopy at baseline and after the intervention.~   "
208901|NCT00826618|"~     Uveitic Cystoid Macular Edema (CME) is a major cause of visual loss associated with uveitis.~     Systemic and/or local corticosteroid therapy and systemic immunosuppression with~     steroid-sparing agents such as cyclosporine, methotrexate, azathioprine, or others,~     effectively treats uveitis and associated CME in many patients. However, in many cases, CME~     persists in spite of adequate suppression of uveitis. No consensus exists on how best to~     treat such cases. The further addition of immunosuppressive agents appears to have little~     effect on this form of CME. Oral corticosteroids are useful, but high dosage and prolonged~     use can be associated with serious side-effects. Periocular and intravitreal corticosteroid~     injections are associated with well-known, significant side effects such as glaucoma and~     cataract formation.~      Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of vascular~     integrity in the eye and known to be induced by inflammatory cytokines, such as interleukin~     interleukin (IL)-1β and IL-6, which are elevated intraocularly in uveitis. In addition, it~     has been demonstrated that aqueous VEGF concentrations are statistically significantly higher~     in those uveitis patients with CME than those without CME. Inhibition of inappropriate VEGF~     activity is a potential approach to treatment of CME in uveitis given our current knowledge~     of the pathophysiology of this condition and also because of the clinical need for additional~     treatment options for these patients. Ranibizumab, a recombinant, humanized monoclonal~     antibody antigen-binding fragment (Fab) that neutralizes all active forms of VEGF-A, would~     target this pathway and may be useful in cases of persistent CME in uveitis patients.~      The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and~     effective in leading to regression of macular edema due to chronic non-infectious uveitis in~     patients with well-controlled uveitis.~   "
208902|NCT00826605|"~     The purpose of this study, then, is to search existing clinic and hospital records for~     answers to the following two questions: (1) Do pregnant women who are at least 37 weeks~     gestation and who have an increase in urubilinogen on urine dipstick at a prenatal~     appointment have a statistically significant shorter average time before going into active~     labor than their negative counterparts? (2) Do pregnant women who are at least 37 weeks~     gestation and who show a modest weight loss between two prenatal appointments have a~     statistically significant shorter average time before going into active labor than their~     counterparts who did not lose weight?~   "
208903|NCT00826592|"~     The purpose of this study is to compare the effect of video-based patient education with~     written instruction on subjects' knowledge of atopic dermatitis and their disease severity,~     measured by the Patient-oriented Eczema Measure (POEM), after viewing the educational~     materials.~   "
208904|NCT00826579|"~     The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in~     all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a~     more accurate histopathological examination (multiple sections, special staining). The~     detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients~     with micrometastases should be considered at higher risk.~      Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.~   "
208905|NCT00826566|"~     Nowadays it has become evident that a chronic systemic inflammation is present in patients~     suffering from chronic obstructive pulmonary disease (COPD).~      The role of the nuclear enzyme poly(adenosine diphosphate-ribose)polymerase (PARP) as a key~     mediator within these systemic inflammatory processes as well as in COPD associated exercise~     intolerance and muscle weakness could recently been identified. The attenuating effect of~     dietary ingredients with PARP inhibiting activity on systemic inflammation was supported by~     data from in vitro and in vivo studies, from other groups as well as from our own lab. We~     identified several caffeine metabolites as potent inhibitors of the most abundant~     PARP-isoform PARP-1 in-vitro, in animal models as well as in ex-vivo experiments with whole~     blood from COPD patients.~      However, clinical data with respect to their anti-inflammatory effects in COPD patients are~     currently not available for none of these substances. Therefore, the current clinical pilot~     study is intended to establish for the first time clinical data (proof of principle) on the~     anti-inflammatory potential of caffeine metabolites.~   "
208906|NCT00826553|"~     The purpose of this study is to study the effect of two standard of care sedative medications~     on sleep stages and total sleep time. The investigators hypothesize that the α2 agonist,~     dexmedetomidine, will improve sleep quality by increasing N2 and N3 sleep as well as total~     sleep time when compared to GABA agonists.~   "
208907|NCT00826540|"~     This phase II trial is studying how well giving sorafenib together with bevacizumab works in~     treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Sorafenib and bevacizumab may also stop the growth of tumor cells by~     blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more~     tumor cells~   "
208908|NCT00826527|"~     The purpose of this study is to demonstrate that solifenacin post-operatively improves~     irritative symptoms in men whose obstructive symptoms have been relieved with the GreenLight~     laser outpatient procedure.~   "
208909|NCT00826514|"~     The purpose of this study is to determine whether tanezumab is effective in the treatment of~     pain associated with chronic prostatitis.~   "
208910|NCT00826501|"~     Patients with pancreatitis can develop inflammatory fluid collection around the pancreas~     called pseudocysts. Pseudocysts may cause abdominal pain when they are more than 6cm in size.~     These pseudocysts can be treated (drained) by surgery or by endoscopy. Both treatment options~     are the current standard-of-care at all institutions around the World. The aim of this study~     is to identify the better of the two techniques, surgery versus endoscopy, for treatment of~     patients with pancreatic pseudocysts. This will be done by comparing a) the rates of~     pseudocyst recurrence b) quality of life of patients following treatment and c) cost~     associated with treatment, between both treatment modalities.~   "
208911|NCT00826488|"~     The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2~     dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the~     appearance of non-calcified breast masses. It is thought that non-calcified breast masses~     will be better visualized with the new 3D technology.~   "
208912|NCT00826475|"~     Patients suffering from migraine will be randomly allocated to one of two different~     behavioral interventions:~        -  mindfulness based stress reduction (MBSR) an eight week intervention program based~          different meditation & yoga techniques and teaching information regarding the~          relationship between stress and health.~        -  into an active control group teaching three times within eight weeks relaxation~          techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine.~          The investigators will measure the frequency and intensity of migraine attacks before~          during and after the intervention as well as secondary variables on quality of life and~          psychological functioning. The hypothesis is that patients allocated to the MBSR~          intervention will reduce the frequency of their migraine attacks compared to the active~          control group and compared to their own baseline.~   "
208913|NCT00826462|"~     The purpose of this study is to compare the clinical effect of physiotherapy alone or~     combined with corticosteroid injection in the initial treatment of lateral epicondylitis in a~     primary care setting.~      To find the short and long term effect of physiotherapy with Mill's manipulation, deep~     friction massage and exercise therapy.~      To ascertain wether the outcome is influenced by corticosteroid injection, which has been~     shown to be of benefit alone in the short term?~   "
208914|NCT00826449|"~     The goal of the Phase I portion of this study is to find the highest tolerable dose of the~     combination of dasatinib and erlotinib hydrochloride that can be given to patients with~     advanced solid tumors.~      The goal of the Phase II portion of this study is to learn if this combination is effective~     when given to patients with non-small cell lung cancer.~      The safety of this combination will be studied in both phases.~   "
208915|NCT00826436|"~     The primary purpose of this study is to assess the safety and tolerability of ascending,~     multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to~     evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal~     women.~   "
208916|NCT00826423|"~     This study is short course (3 month) multiple drug antibiotic therapy. The purpose of this~     research study is to evaluate the clinical and radiology response to assess whether drug~     resistance develops and assess quality of life measures with MAC disease.~   "
208917|NCT00826410|"~     The aim of the study is to determine wether subcutaneus suction drain (type redon-drain)~     protect against surgical side infection by laparotomy in general surgery.~   "
208918|NCT00826397|"~     This is a randomized, controlled, pilot study to determine the safety and efficacy of~     acupuncture as an adjunct to pharmacological treatment compared to pharmacological~     intervention alone for the treatment of musculoskeletal pain related to aromatase inhibitors~     (AI) in postmenopausal breast cancer patients. Twenty participants (20 in each arm) will be~     enrolled at the Breast Oncology clinic at Columbia University Medical Center (CUMC). Patients~     in the treatment arm will receive acupuncture administered twice weekly for six weeks and~     will be allowed to take pain medication as necessary. The control patients will initially~     receive pain medication alone, then will cross-over to the acupuncture arm after six weeks.~     The investigators hypothesize that acupuncture will reduce AI induced joint symptoms.~      The study will enroll a total of 40 patients, half of whom will be randomized to one of the~     two arms to receive acupuncture plus pharmacological treatment (arm A) or pharmacological~     treatment alone (arm B). Joint pain will be assessed by the BPI-SF score at baseline and six~     weeks. All patients will have a baseline BPI worst pain item (#2) ≥3 points on a scale of~     0-10.~   "
208919|NCT00826384|"~     According to radiology imaging, the patients of HCC are divided into two groups(hypovascular~     tumor group and moderately vascular tumor group). Every group is divided into TACE therapy~     with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE~     therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All~     objects are observed until the end event happening or in the group for 6 months.~   "
208920|NCT00826371|"~     The purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5~     mg intravitreal injections in Chinese patients with subfoveal choroidal neovascularization~     (CNV) secondary to age-related macular degeneration (AMD). The study results will support the~     regulatory submission in China to make ranibizumab available for clinical use.~   "
208921|NCT00826358|"~     The purpose of this study is to evaluate the safety and compare the pharmacokinetic~     parameters from the fixed dose combination ABT-143 relative to that from the~     co-administration of the two monotherapies.~   "
208922|NCT00826345|"~     This preliminary study will investigate the use of Acupuncture and Moxibustion (Acu/Moxa) for~     distal symmetric peripheral neuropathy (DSP) associated with HIV applying traditional Chinese~     medicine (TCM) evaluations conducted by a diagnostic acupuncturist. The investigators will~     evaluate the role of Acu/Moxa in reducing the symptoms of DSP related to HIV/AIDS and~     treatment side effects. The effects of symptom reduction on quality of life will also be~     examined. This application will establish a proof of principle for the role of Acu/Moxa in~     the treatment of DSP and provide data that will serve as a foundation for establishing a~     future larger clinical trial.~   "
208923|NCT00826332|"~     Embryo transfer is the last step in the IVF process. it is now recognized that this step~     should be done carefully and that it affects success rates. in recent years, sonographic~     guidance appears to increase success rates.~   "
208924|NCT00826319|"~     This study will follow 2500 prevalent Chronic Kidney Disease (CKD) patients with Glomerular~     Filtration Rate (GFR) from 15-45 ml/min for 30 months with serial measurements every 6 months~     and subsequent annual chart review up to 60 months. This observational study will analyze the~     demographics, clinical status, medications and blood and urine samples of these patients and~     study the conventional biochemical, hormonal and metabolic parameters assessing which~     underlying biomarkers reflect the processes involved with disease progression.~   "
208925|NCT00826306|"~     The purpose of this study is to compare the effect of video-based patient education with~     written instruction on subjects' adherence to sunscreen application.~   "
208926|NCT00826293|"~     Application of a belt for stabilization while exercising accelerate and optimize recovery in~     patients diagnosed with shoulder impingement syndrome.~   "
208927|NCT00826280|"~     Observe whether the administration of caffeine prior to regadenoson will affect the~     interpretation of test results in subjects with coronary artery disease (CAD) undergoing~     SPECT MPI~   "
208928|NCT00826267|"~     An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a~     single agent versus lapatinib versus trastuzumab in patients with HER2-positive~     treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be~     obtained on the safety profile and pharmacokinetics of BIBW 2992.~   "
208929|NCT00826254|"~     Part 1) Bone health after transplantation - possible influence of vitamin K~      Part 2) Fat metabolism and endocrine parameters - possible predictors for developement of~     overweight after transplantation~   "
208930|NCT00826241|"~     The goal of this clinical research study is to learn if lapatinib when given in combination~     with temozolomide can help to control ependymoma that has come back after treatment. The~     safety of this combination will also be studied.~   "
208931|NCT00826228|"~     Individuals with spinal cord injury sustain significant loss of bone mass in their lower~     extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two~     interventions that build bone, to increase bone mass in this population.~   "
208943|NCT00826072|"~     Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass,~     and it is significantly related to prolonged postoperative recovery, hospital stays and~     medical cost. Currently available predictors of acute lung injury after cardiac surgery are~     still limited within clinical data. Several genetic polymorphism of inflammatory mediators~     have been reported to be associated with severity of sepsis and ARDS, but the association of~     these inflammatory polymorphism and acute lung injury after cardiac surgery has never been~     reported. This study is performed to investigate the association of genetic polymorphisms~     including TNF -308A/G, IL-10 -1082A/G and IL-6 -572C/G and postoperative lung injury.~   "
208932|NCT00826215|"~     Objective: The primary objective of this study is to evaluate the long-term efficacy of~     electroacupuncture for chronic neck pain. The secondary objective is to document any possible~     side effects of acupuncture.~      Design and Subjects: Prospective, randomised controlled trial comparing the outcomes of~     treatment and placebo interventions. Subjects are 200 adult patients with chronic mechanical~     neck pain.~      Setting: Outpatient clinics.~      Interventions: Patients will be randomly allocated to one of the two groups receiving either:~     electroacupuncture (real treatment) or placebo (sham laser acupuncture). Each treatment will~     last for 45 minutes. Each patient will receive a total of nine treatments (three times per~     week for three weeks).~      Main outcome measures:~      Primary outcome measures: Neck pain disability index (Northwick Park Neck Pain~     Questionnaire).~      Secondary outcome measures: Maximum pain related to motion on visual analogue scale. Quality~     of life (SF-36). Use of medication. Sick leave because of neck pain. Treatment-related~     adverse effects, such as pain, skin irritation, bleeding and dizziness, will also be~     assessed.~      Assessments will be made before treatment, one month, three months and six months after the~     treatment course. The credibility of placebo treatment will also be assessed.~      Expected results: We expect that patients in the treatment group will have significant~     improvements on primary and secondary outcome measures, when compared with patients in the~     inert placebo group.~      Conclusion: This study will provide credible evidence regarding whether electroacupuncture is~     effective in reducing chronic neck pain. Patients, healthcare professionals, and government~     policy makers can make use of this information to improve clinical outcomes and reduce costs~   "
208933|NCT00826202|"~     The purpose of the study is to determine the safety and efficacy of D-serine as an early~     intervention treatment for the schizophrenia prodrome condition. This study is a~     placebo-controlled trial of D-serine in the symptomatic treatment of patients with the~     schizophrenia prodrome. Seventy two subjects meeting criteria for the schizophrenia prodrome~     will be included in this study, 24 at each site (Yale, Nathan Kline Institute and Zucker~     Hillside Hospital). The primary outcome measures will include symptom and neuropsychological~     measures. The duration of this study is two and a half years.~      This research with D-serine holds out the prospect of direct benefit for the patient's~     current symptoms. Subjects may also benefit from the close monitoring of their symptoms, so~     that, if schizophrenic psychosis does occur, the psychosis will be recognized and treatment~     may begin with minimal delay. This study also could be of benefit by suggesting a promising~     lead in early intervention in the schizophrenic prodrome.~      Overall Design Summary. We propose for prodromal patients to be randomized to D-serine vs~     placebo for 16 weeks. To insure that all subjects have the opportunity to receive D-serine,~     there will be an optional 16 week cross-over trial on the alternate study medication. No~     subject will be on D-serine for longer than 16 weeks. Admission criteria, Assessment~     Procedures, and Study Design will be the same across all sites. The procedures and timeline~     are shown in Table 1. The procedures and timeline are the same for the initial randomized 16~     week trial and the optional cross-over trial on the alternate study medication. If patient's~     opt for the 16 week treatment on the alternate medication, we will use their assessments from~     end of initial treatment as baseline for 16 week treatment on alternate medication. Subjects~     will be seen for two preliminary visits, then once in treatment, subjects will be seen weekly~     for the first 5 visits then biweekly thereafter. A safety blood and urine collection will be~     done on day 3 (3 days after the start of study medication). Vital signs and weight, blood~     draw and urine collection for safety measures, urine pregnancy test and urine for toxicology~     will be repeated throughout treatment. Adverse effects ratings and symptom assessments will~     be repeated at each visit. Neuropsychological assessment and optional Biomarker study~     visual, auditory and ERPs tasks will be administered during one of the two preliminary visits~     then again at study endpoint. Any patients who convert to frank psychosis will be~     referred/offered immediate treatment.~   "
208934|NCT00826189|"~     The investigators had conducted an initial double-blind, placebo-controlled clinical trial~     (NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of age~     in the incidence of atopic diseases at 2 years old. This is then further investigated up to 5~     years of age in a follow-up study NCT00365469 to assess the longer term beneficial effects.~      This current study intends to follow-up for another 2 years until 7 years of age as this is~     critical in the evaluation of respiratory allergies in the form of clinical asthma and~     allergic rhinitis.~   "
208935|NCT00826176|"~     The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in~     Chinese and Caucasian subjects for registration purposes in China.~   "
208936|NCT00826163|"~     We hypothesize that ongoing and more severe airway inflammation in COPD may result from the~     impairment in activation of innate immune response~   "
208937|NCT00826150|"~     This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and~     preliminary efficacy of DTA-H19 administered intraperitoneally (IP) in subjects with advanced~     stage ovarian cancer, or primary peritoneal carcinoma~   "
208938|NCT00826137|"~     Prospective randomized double-blind study on the effect of prebiotics (inulin and~     fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.~   "
208939|NCT00826124|"~     Epidural steroid injections (ESI) are the most frequently performed procedures in pain~     clinics. When performing ESI, there is no consensus about how to best select candidates for~     this intervention, and which level(s) to inject. Some experts advocate basing the injection~     level on MRI findings, whereas others recommend clinical symptoms. In order to determine~     whether MRI is necessary before referring patients with chronic LBP radiating into the leg(s)~     for pain management interventions, we will perform a randomized comparative study involving~     131 patients with chronic low back and leg pain who are clinically candidates for epidural~     steroid injections into two groups. Group I will receive two ESI based solely on historical~     and physical exam (PE) findings. Group II will receive treatment only after MRI is reviewed.~      The investigators' hypothesis is that MRI will not have a significant effect on treatment~     outcome, and will have minimal impact on patient care.~   "
208940|NCT00826111|"~     The study examined the effects of adding the sleep aid eszopiclone to Lexapro on mood and~     levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression,~     anxiety, and insomnia. Specifically, the objective was to determine the role of glutamate,~     glutamine, and GABA in mediating the response the to the combined treatment. The hypothesis~     was that levels of glutamine and glutamate will be increased in women receiving eszopiclone~     compared to those receiving placebo. The antidepressant effect of the medication combination~     and its effect on sleep status was also assessed.~   "
208941|NCT00826098|"~     The purpose of this clinical study is to evaluate the effect of platelet rich plasma (PRP), a~     derivative of a patient's whole blood, on short-term patient outcomes following total knee~     replacement (TKR). The hypothesis is that change in short-term hemoglobin (Hgb) levels is~     less dramatic in patients who undergo TKR with the addition of PRP when compared to patients~     who undergo TKR without PRP.~   "
208942|NCT00826085|"~     This is a research study to evaluate the effects of ThermoDox in combination with therapeutic~     heating of the chest wall in the treatment of recurrent regional breast cancer. The purpose~     of this study is to evaluate the bioequivalence of ThermoDox and measure efficacy in~     recurrent chest wall patients.~   "
220141|NCT00677378|"~     We would like to evaluate the changes in nerve innervation and TRPV1 receptor expression~     along with microscopic changes associated with heart burn and abdominal pain~   "
208944|NCT00826059|"~     The primary objective of the study is to assess the safety and effectiveness of SPG~     stimulation with the ISS in patients with an acute ischemic stroke in the anterior~     circulation initiated within 24 hours from stroke onset.~   "
208945|NCT00826046|"~     This protocol allows for the treatment of patients, male and female, between the ages of 18~     years and 70 years. Patients must have failed to respond to steroid treatment for Grade C-D~     acute GVHD.~   "
208946|NCT00826033|"~     L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography~     (PET). The investigators evaluated the value of 18F-FMT PET for the assessment of therapy~     response in patients with lung cancer as compared with that of~     2-[18F]-fluoro-2-deoxy-D-glucose (18F-FDG) PET.~      The patients with lung cancer underwent PET studies with 18F-FDG and 18F-FMT before and after~     radio-/chemotherapy. The investigators used the ratio of the SUVmax of the mediastinal (N2)~     lymph node to the SUVmax of the primary tumor (N/P ratio ). All patients were divided into~     two groups of N/P ratio<1 and N/P ratio≥1, and the survival time was estimated by~     Kaplan-Meier method.~   "
208947|NCT00826020|"~     The purpose of this study is to determine if established parenteral nutrition (PN) associated~     liver disease can be reversed or its progression halted by using a parenteral fat emulsion~     prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and~     bilirubin.~   "
208948|NCT00826007|"~     The purpose of the study is to review incidences of mild, moderate, and severe hypoglycemia~     in preoperative care units, operating rooms, and postanesthesia care units and analyze~     associated conditions and treatment.~   "
208949|NCT00825994|"~     The purpose of this study is to determine if an eight-week intervention with omega-3 fatty~     acids significantly reduces depressive symptoms in symptomatic peri- and postmenopausal~     women. We hypothesize that an eight-week trial with omega-3 fatty acids promotes significant~     improvement in depression symptoms in peri- and postmenopausal women.~   "
208950|NCT00825981|"~     Patients undergoing elective coronary artery bypass graft surgery (CABG) are treated with~     platelet inhibitors to reduce myocardial infarction and mortality.However, this can increase~     perioperative bleeding. A retrospective analysis of the data in our institution has revealed~     a significant increase in transfusion requirements after elective CABG since 5 years. The aim~     of our study is to observe if this increase in transfusion requirements is due to platelet~     inhibitors or due to other coagulation abnormalities resulting from other anticoagulants.~   "
208951|NCT00825968|"~     The purpose of the database is to complete outcomes research of electrophysiological~     procedures.~   "
208952|NCT00825955|"~     The purpose of this study is to determine if Brivanib is an effective treatment for liver~     cancer in patients who have failed or could not take Sorafenib~   "
208953|NCT00825942|"~     To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with~     asteroid hyalosis~   "
208954|NCT00825929|"~     Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one~     cannot assume that the currently licensed doses of the medication to be tested under this~     protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under~     study no or limited pharmacokinetic data during pregnancy are available. As the changes in~     pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic~     curve will be recorded in the third trimester after attaining steady state.~   "
208955|NCT00825916|"~     The purpose of this study was to determine the safety of AZX100 Drug Product and to determine~     whether it was effective in preventing or reducing re-growth of surgically removed keloid~     scars.~   "
208956|NCT00825903|"~     Exercise has been shown to have extensive health benefits both in normally functioning adults~     as well as in adults with asthma. A program of regular aquatic exercise may have unique~     benefits in the asthmatic population because of the known aerobic capacity development~     typical of such programs, combined with the unique value of immersion-produced improvements~     in respiratory endurance and cardiac output. The purpose of this study is to explore the~     effects of a 12 week long aquatic endurance training program on several physiological and~     psychological parameters related to coronary heart disease and type II diabetes in an~     asthmatic population.~   "
208957|NCT00825890|"~     To investigate of high cup/disc ratio in children.~   "
208958|NCT00825877|"~     The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) trial is a~     multicenter clinical trial conducted to assess the effects of long-term antiviral drug~     therapy on the progression of liver disease in patients who have advanced chronic hepatitis C~     and have not responded to prior therapies. Chronic hepatitis C is a long-lasting viral~     infection affecting the liver that may lead to permanent liver damage and cirrhosis~     (replacement of healthy liver cells by scar tissue). If left untreated, a proportion of~     patients with chronic hepatitis C will be at risk for complications of liver disease. The~     drug therapy in the HALT-C trial was designed to clear the hepatitis C virus from the patient~     s system in order to prevent or mitigate these potential complications. The purpose of this~     research is to determine if patients with chronic hepatitis C who experienced clearance of~     hepatitis C virus (known as a sustained virologic response, or SVR) during the HALT-C trial~     have developed any complications of their liver disease.~      This study will include 180 subjects who participated in the initial phase of the HALT-C~     trial and experienced an SVR. The participants will visit the National Institutes of Health~     for an in-person study visit.~      During the visit, patients will have blood drawn for lab tests to monitor the progress of~     their liver disease, and may be asked to undergo an ultrasound examination of the liver to~     detect any abnormalities that may be attributed to liver cancer. Patients will also answer~     questions about their medical history particularly any outcomes or events related to their~     hepatitis C that have occurred since the HALT-C trial and may be asked to sign a release of~     information to allow researchers to obtain medical records from other clinics or physicians~     where they have received treatment.~   "
208959|NCT00825864|"~     To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of~     trabeculectomy and cataract surgery.~   "
208960|NCT00825851|"~     The aim was to determine the wound healing capacity in healthy never smokers and smokers who~     continue to smoke, or quit smoking using transdermal nicotine patch versus placebo patch.~   "
208961|NCT00825838|"~     The purpose of this study is to test the safety and effectiveness of a purified extract of~     CH-19 Sweet, containing capsinoids.~   "
208962|NCT00825825|"~     Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake~     inhibitors that alter blood flow to the amygdala and other brain structures involved in~     regulating mood. Escitalopram consists of S-citalopram while citalopram contains both~     S-citalopram and R-citalopram (racemic citalopram). There is evidence that R-citalopram may~     block the effects of S-citalopram. The hypothesis being tested is that because of the~     antagonist effect of R-citalopram, S-citalopram will have a greater effect on the mood~     circuit than racemic citalopram when equal doses of S-citalopram are administered. The study~     design consists of a two week medication period followed by blood oxygen level dependent~     (BOLD) functional magnetic resonance imaging (fMRI) while viewing affective visual stimuli.~   "
208963|NCT00825812|"~     The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex~     compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects~     for registration purposes in China.~   "
208964|NCT00825799|"~     The goal of the study is to validate a biomarker assay for unipolar depression based on serum~     proteins involved in inflammation, metabolism, and stress response. The study will compare~     patients with a current major depressive episode to individuals with no history of~     depression. The hypothesis is that the assay can serve as a diagnostic tool that would be~     more objective than standard diagnostic questionnaires.~   "
208965|NCT00825786|"~     This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90~     seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a~     quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local~     anesthetics.~   "
208966|NCT00825773|"~     E.V.O.L.U.T.I.O.N.: A Randomized Study to Evaluate Safety and Efficacy of the Excel Sirolimus~     Eluting Stent with a Biodegradable Polymer Versus Sirolimus Eluting Stent with a~     Non-Biodegradable Polymer in the Treatment of Patients with de novo Coronary Artery Lesions.~   "
208967|NCT00825760|"~     Some leg ulcers do not seem to respond that well to the standard treatments that we currently~     use. One reason for this may be that there are high levels of bacteria in the ulcer which may~     be slowing down the rate of healing. Because we need to be careful about when we use~     antibiotics, this study will look at another way of killing bacteria in the ulcer. This new~     method involves putting a special gel on the ulcer and then shining a particular type of~     light (visible red light) onto the ulcer for a short period of time.~      In the first part of the study, a single treatment with the gel and light will be~     investigated. The second part of the study will compare whether or not using the treatment~     once a week for 12 weeks is better than placebo.~      Across the UK 57 people with chronic leg ulcers will be asked to take part in this study (9~     in part 1 and 48 in part 2). Up to 10 sites will be involved including Cardiff University and~     hospitals in Bradford, Harrogate, Dundee, Hull, Plymouth and the Wirral.~      The research is funded by Photopharmica Ltd.~   "
208968|NCT00825747|"~     Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation.~     The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an~     acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and~     secondary cataract formation rate.~      Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp~     examination and biometry.~      Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm),~     phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation~     parameters will be evaluated by the surgeon.~      Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction~     and comprehensive slit lamp examinations up to 3 months after surgery.~   "
208969|NCT00825734|"~     In this study, patients with metastatic HER2-negative breast cancer will receive treatment~     with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The~     Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib~     and ixabepilone that may be used in combination for first- or second-line treatment of MBC.~     The MTDs identified in the Phase I portion of the study will be used in the Phase II portion~     which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone~     in patients who have received at least one prior chemotherapy treatment in either the~     adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who~     had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one~     of the initial trials investigating the use of this treatment combination for MBC.~      This trial will be conducted under the leadership of the Sarah Cannon Research Institute~     (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial~     organization.~   "
208970|NCT00825721|"~     This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution~     in patients with loss of visual function due to age-related nuclear cataract~   "
208971|NCT00825708|"~     The aim of the study is to evaluate the immediate effect of rTMS on attention in adults~     diagnosed with ADHD. the design is a double blind sham controlled crossover study.~   "
208972|NCT00825695|"~     The purpose of the study is to learn whether or not cocoa has a beneficial effect on blood~     flow to the brain in older subjects with diabetes mellitus or hypertension (high blood~     pressure). We hypothesize that cocoa, which contains flavanols (a type of polyphenol), may~     help to promote blood flow to the brain in older people with diabetes or hypertension.~   "
208973|NCT00825682|"~     Oncologic patients often report increased fatigue during and after radiation therapy.~     Reflexology treatment has been demonstrated to alleviate symptoms of fatigue, nausea, and~     anxiety in oncologic patients treated with chemotherapy. The aim of the study is to evaluate~     the effect of reflexology on fatigue, quality of life, and quality of sleep of breast cancer~     patients during and after radiation therapy.~   "
208974|NCT00825669|"~     Hepatectomy is still the treatment of choice for hepatocellular carcinoma. Part of the~     patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might lead to~     upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life~     of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There~     is no standard treatment for PVTT yet. We aim to compare the effects of TACE and TACE plus~     laser ablation for treating patients with PVTT.~   "
208975|NCT00825656|"~     The purpose of this study is to demonstrate the equivalence of two homeopathic capsaicin~     containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to~     allergic rhinitis.~   "
208976|NCT00825643|"~     This study is conducted in Europe, North America and Asia. The aim of this observational~     study is to evaluate the safety and effectiveness while using Levemir® once daily in~     combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal~     clinical practice.~      Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and~     reported together in the final study report for this study.~   "
208977|NCT00825630|"~     Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test~     (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and~     after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in~     each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath~     Test). The aim of the trial is to observe the effect of different PPIs on the breath test and~     choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a~     minimal effect on the UBT while using selected PPIs.~   "
208978|NCT00825617|"~     Several studies have demonstrated that Turner Syndrome patients have elevated liver enzymes~     readily suppressible by a short course of HRT. We wanted to estimated quantitative liver~     functions in a young group of Turner syndrome patients compared to a healthy control group.~   "
208979|NCT00825604|"~     The purpose of this study is to, in patients with stable angina pectoris, assess the~     additional benefit of PCI on top of optimized medical treatment, physical training and~     smoking cessation with regard to quality of life, achievement of target of treatment and~     clinical events such as death, acute myocardial infarction, stroke and revascularization.~   "
208980|NCT00825591|"~     Background: Optic Nerve Hypoplasia (ONH) is a leading cause of blindness in children. For~     unclear reasons, the incidence of ONH is increasing, with ONH affecting about 1 in 10,000~     live-born infants. In addition to visual deficits, ONH is associated with varying degrees of~     hypopituitarism, developmental delay, brain malformations and obesity. Although genetic~     mutations have been rarely observed to result in ONH, the causes of ONH are largely not~     known. In limited anatomical observations, the suprachiasmatic nuclei (SCN) located in the~     anterior hypothalamus, which generate circadian rhythms, have been observed to be abnormal in~     children with ONH. Thus, children with ONH may have biological clock dysfunction.~      In collaborative studies with Dr. Mark Borchert of Childrens Hospital Los Angeles (CHLA), we~     have recently discovered that one-half of children with ONH have grossly abnormal sleep-wake~     patterns, as assessed by actigraphy. Although not known for children with ONH, abnormal~     sleep-wake patterns have been observed to be associated with neurocognitive impairment and~     obesity. We also observe that nocturnal melatonin administration can improve abnormal~     sleep-wake cycles in these children, raising the possibility that it will be possible to~     treat abnormal rhythmicity in children with ONH.~   "
208981|NCT00825578|"~     Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other~     than the upper lobes, as determined by high resolution computed tomography (HRCT), could have~     a positive response to valve treatment.~   "
208982|NCT00825565|"~     The purpose of this study is to determine how safe and effective allantoin 3% cream~     (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall~     blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically~     to the entire body once daily.~   "
208983|NCT00825552|"~     The purpose of this study is to investigate whether Risperidone is effective in children and~     adolescents with severe mood dysregulation.~   "
208984|NCT00825539|"~     Part 1 of the study will assess the enhancement of task-related brain activation (BOLD~     response) in key brain areas in schizophrenia during the performance of working memory,~     episodic memory and visual activation tasks as measured by functional magnetic resonance~     imaging (fMRI) in people with schizophrenia. Part 2 of the study will assess the safety and~     tolerability of multiple doses of AQW051 in people with schizophrenia.~   "
208985|NCT00825526|"~     The purpose of this study is to determine if Mindfulness Based Stress Reduction (MBSR) is an~     effective intervention for lowering blood pressure in early unmedicated hypertensives.~   "
208986|NCT00825513|"~     The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL~     following cataract surgery.~   "
208987|NCT00825500|"~     Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe~     migraine headache with or without aura in an outpatient setting.~   "
208988|NCT00825487|"~     This is an open-label, dose escalation study of intravenous ARQ 621 administered to patients~     with late-stage solid tumors or hematologic malignancies.~   "
208989|NCT00825474|"~     Presently,the diagnostic method of small hepatocellular carcinoma has been greatly elevated~     in China.The treatment is being from simplification to diversification,from entirety to~     individualization.Confronting small hepatocellular carcinoma,we not select simple operation~     treatment but select a treatment that have more predominance and more fitting with patients~     in various kinds of treatment methods;including operation ,TACE,PEI,et al.which is better ?~     There are many arguments.~   "
208990|NCT00825461|"~     The PICOWO research group in corporation with the University of Amsterdam (Artificial~     Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos,~     Jonker & Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea~     for this current research is to collect clinical information about the functioning and~     (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.~   "
208991|NCT00825448|"~     The aim of the study is to compare the hospitalisation period in ORL surgery for two groups~     of patients. One of them will be treated for alcohol addiction to weaning them before the~     surgery ORL. The other group will be treated with usual methods.~   "
208992|NCT00825435|"~     This study will evaluate the impact of adding coronary computed tomographic angiography (CTA)~     on health care costs for diagnosing patients with acute chest pain.~   "
209015|NCT00825123|"~     The purpose of this project is to determine the effects of slowing heart rate upon both~     central and peripheral blood pressures using Ivabradine. The effects of Ivabradine will be~     compared to Metoprolol and placebo.~      Participants will attend the hospital for 3 visits where they will be randomised to receive~     either Ivabradine, Metoprolol and placebo on each visit. Non-invasive measures of blood~     pressure will be recorded before and after consuming the study drug.~   "
228699|NCT00563524|"~     The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094~     administered to subjects with psoriasis~   "
208993|NCT00825422|"~     Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's~     postoperative reconvalescence especially functional rehabilitation. Efficient and safe~     methods for postoperative analgesia are, therefore, mandatory. The application of opioids are~     the most frequently used therapies for postoperative pain relief but it very often results~     side effects. Local anesthetic wound infiltration is widely recognized as a useful adjunct in~     a multimodal approach to postoperative pain management. In the setting of spine surgery, a~     single bolus administration of a local anesthetic is a useful method (with a reduction in~     parenteral morphine consumption during the 48 first hours) but has a limited effect because~     of its short duration of action. Prolonged administration through a multi-holed catheter~     positioned by the surgeon at the end of the procedure could increase the duration of action~     and may thereby improve the efficacy of local wound infiltration. Easy and effective, this~     new modality of administration has expanded the indications for parietal infiltrations toward~     major painful procedures.~      We designed this study to determine whether local anesthetic (compared with saline solution)~     continuous wound infiltration during the first two days after posterior lumbar arthrodesis on~     degenerative spine, could improve postoperative analgesia at short-term but particularly at~     mid-term (two months) and long-term (six months), in order to decrease postoperative lumbar~     pains (resulting in best life quality, opioid consumption limited and rehabilitation~     hastened) and postoperative hyperalgesia areas. The postoperative analgesic and~     antihyperalgesic efficacies; the postoperative rehabilitation at mid-term and long term, and~     the safety of opioid administration and multi-holed parietal catheter will be compared in the~     two groups (control and study).~   "
208994|NCT00825396|"~     The purpose of this study is to determine the safety and tolerability of topical C-KAD~     Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension.~   "
208995|NCT00825383|"~     Effect of Dietary Fiber on glucose, lipid, and mineral metabolism in patients with non~     insulin dependent diabetes mellitus.~   "
208996|NCT00825370|"~     We are testing whether patients who received protocolized pain management (1 mg of IV~     hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later~     if the patients wants more) will have better pain relief and no more adverse events than~     patients receiving discretionary care, in which the patients receives whatever IV opioid the~     treating physician wants to give, in whatever dose.~   "
208997|NCT00825357|"~     There are no clear markers to identify sepsis and acute lung injury at early stage in~     clinical settings which would result in improved survival of the patients. In collaboration~     with the research team led by Dr. Zhang at St. Michael's Hospital, Toronto, we have initiated~     a pilot study looking for biological markers to detect severe sepsis and ARDS. We have found~     that human neutrophils peptides (a-defensins), certain coagulation variables and cytokine~     levels are very sensitive markers to differentiate severe sepsis, ARDS from cardiovascular~     diseases in ICU patients. These findings may provide valuable information for therapeutic~     guideline in clinical practice. The present study will focus on testing 'biological markers'~     to identify patients with sepsis and acute lung injury. We will examine the roles of three~     components of markers including inflammation, neutrophil activation and coagulation. We are~     hoping that this proposed translational research will help develop novel therapeutic strategy~     in sepsis and acute lung injury patients.~   "
208998|NCT00825344|"~     Inguinal hernia repair is one of the most frequently performed operations in young men.~     Persistent pain after inguinal surgery represents a significant cause of disability,~     occurring in between 15%-35% of cases. In a majority of these patients, their groin pain~     persisted after a previous hernia repair. The main type of chronic postsurgical pain is~     neuropathic, caused by injured nerves. One of the principal components in the pathophysiology~     of postsurgical pain is cytokines, specifically tumor necrosis factor (TNF). In animal~     studies, injecting TNF inhibitors before nerve injury can reduce pain behaviors and~     neuropathology. Finding a way to reduce the incidence of postsurgical pain after hernia~     repair could enhance function, and reduce the need for opioids and other analgesics. The~     investigators intend to conduct the first randomized, controlled study evaluating whether~     preemptive administration of a tumor necrosis inhibitor can reduce postoperative pain and~     opioid consumption after hernia repair. This is important because the degree and intensity of~     postsurgical pain is a major predictor for the development of chronic postsurgical pain.~   "
208999|NCT00825331|"~     Periprocedural management of guidewire placement and removal in patients needing cardiac~     catheterization by use of marking of the access site and removal procedure due to a graduated~     scheme~   "
209000|NCT00825318|"~     In this study, the researchers want to find out how patients who have ultrafiltration~     (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid~     and waste products) do in terms of their blood pressure and weight. The researchers believe~     that maintaining patients at their estimated target weight throughout the week using daily~     ultrafiltration will reduce their blood pressure to levels shown in other similar studies.~     Such a reduction in blood pressure may reduce the incidence of cerebral vascular disease,~     peripheral vascular disease, coronary artery disease, and congestive heart failure. The~     researchers also believe that patients' quality of life will improve while they are~     undergoing daily ultrafiltration.~      Studies show that more frequent dialysis treatments result in fewer symptoms for patients.~     The patients feel better and avoid the weight gains and symptoms that patients have on three~     times a week dialysis. In addition, their blood lab results are better controlled, requiring~     less medication.~   "
209001|NCT00825305|"~     This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick~     Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus~     abbreviated schedule) in healthy adults 18 to 50 years of age in China~   "
209002|NCT00825292|"~     Colon cancer is the third most common cancer in western society. To prevent colon cancer it~     is recommended for people to undergo a screening colonoscopy at the age of fifty. The purpose~     of the colonoscopy is to remove polyps, since some of these lesions are precancerous.~     Precancerous polyps are called adenomas. This method of prevention is effective, but the~     standard colonoscopy currently used does not detect all polyps. Studies have reported a polyp~     miss rate of about 24%. Furthermore, we are unable to distinguish precancerous polyps from~     benign polyps, also known as hyperplastic polyps, with standard colonoscopy. This results in~     all polyps being removed at time of colonoscopy, even the benign polyps.~      To help improve the detection of colon polyps new endoscopic technologies have been~     developed. These technologies include high definition white light (HDWL)and high definition~     narrow band imaging (HDNBI). HDWL improves the overall resolution of the images seen during~     colonoscopy. HDNBI can help us better classify polyps by enhancing their tissue appearance as~     well as seeing small blood vessels and capillaries.~      The goal of this study to determine if HDNBI imaging shows an increased polyp detection rate~     when compared to the current standard colonoscopy. In addition to develop a classification~     system to help better differentiate between precancerous polyps and their benign counterparts~     using HDWL and HDNBI.~   "
209003|NCT00825279|"~     The success of stent implantation has led to the increasingly widespread use of them in the~     treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent~     restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation~     of stents with improved coating materials and the development of polymers that release~     different kinds of drugs that prevent the activation and/or proliferation of smooth muscle~     cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this~     matter. The new generation of stents with biodegradable polymers and short time of drug~     release gives new advantages to this therapeutic, multiple studies and registries challenge~     this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III).~      For this reason the present study aims to compare a stainless steel stent with a drug eluting~     stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.~   "
209004|NCT00825266|"~     The purpose of this study is to evaluate 1) the incidence of insulin resistance (a~     pre-diabetic state) in patients with pulmonary hypertension, and 2) test the utility of a~     validated PH therapy (Tracleer) versus Pioglitazone in the treatment of those patients found~     to have insulin resistance.~   "
209005|NCT00825253|"~     This trial is conducted in Europe. The aim of this clinical trial is to compare the~     pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire~     observation phase from the time of administration and the efficacy period) and the~     pharmacokinetics (i.e. amount of the study insulin that can be determined in the blood) of a~     treatment with biphasic insulin aspart 30 (BiAsp 30) administered once, twice or thrice daily~     and biphasic human insulin 30 administered once daily in type 2 diabetic subjects~   "
209006|NCT00825240|"~     The overall goal of this study is to explore colorectal cancer patients' concerns and~     interest about their health and behavior changes post treatment. Investigators will conduct~     formative research, which includes qualitative interviews, to assess the issues that cancer~     survivors are willing to work on as they transition out of active treatment.~      The specific aims are as follows:~      Aim 1: Use qualitative interview methods to describe the taxonomy of domains health promotion~     and illness prevention behavior changes for which colorectal cancer survivors need new~     information, skills training and support.~      Aim 2: Explore colorectal cancer patients' perceptions of their post treatment functional~     status.~      Aim 3: Explore the impact of cancer, treatment, and co-morbidities on colorectal cancer~     patients' health goals and functional status.~   "
209007|NCT00825227|"~     Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue~     Associated With Taxane Chemotherapy Alone or in Combination With Other Agents~   "
209008|NCT00825214|"~     Mosquito bites commonly result in redness, swelling and itching. This study will determine if~     a device that emits a small piezo-electrical impulse can provide relief from these symptoms.~     Volunteers entering the study will have a mosquito bite on one forearm. Redness and~     irritation will be recorded periodically for 24 hours. Comparing data from subjects~     randomised to the treatment or a placebo device will be analysed to determine effectiveness~     of the product. We will also ask the subjects their view on how easy the product is to use~     and clarity of instructions provided.~   "
209009|NCT00825201|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle~     formulation directly into the abdomen may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal~     paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced~     cancer of the peritoneal cavity.~   "
209010|NCT00825188|"~     Obesity and hypertension are independent risks for congestive heart failure (CHF) and chronic~     kidney disease. In obesity induced hypertension, the most common cause of human essential~     hypertension, the potential importance of mineralocorticoid receptor blockade has not been~     widely investigated. We propose to test the hypothesis that eplerenone reduces metabolic~     demand, improves cardiac function and attenuates glomerular hyperfiltration and~     microalbuminuria in obese patients. Our specific aims are to assess changes in basal~     metabolic rate, cardiac and renal function in obese hypertensive subjects treated with~     eplerenone compared to amlodipine.~   "
209011|NCT00825175|"~     This study determines the effect of orthotic use in combination with treadmill training on~     the development of gross motor skills and walking onset in infants with Down syndrome.~   "
209012|NCT00825162|"~     A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of~     CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18~     Years~   "
209013|NCT00825149|"~     This open-label, randomized, phase Ib study will assess the safety and efficacy of~     obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP~     (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction~     chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular~     Lymphoma (FL). Participants with complete response or partial response after induction~     therapy may receive maintenance therapy every 3 months for 2 years or until disease~     progression, whichever comes first. All participants in the induction period of the study~     will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab +~     chemotherapy, and will be followed for at least 2 years, unless they are being treated in~     maintenance or discontinue from the study prior to this time point. Participants who~     complete/discontinue maintenance therapy will also be followed for a period of 2 years after~     receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.~   "
209014|NCT00825136|"~     Internet plays a more and more important role in many applications of healthcare. Many~     researches on the integrations of internet and mental health care have been proposed in~     recent years. This project aims at the development of an online treatment system which~     combines the biofeedback therapy and the web technologies to treat the patients suffering~     from panic disorder with partial response to medications. This project also evaluates the~     efficacy of a new- designed wireless temperature biofeedback ring.~   "
209037|NCT00824837|"~     The purpose of this study is to determine whether a novel haemodialysis membrane, compared~     with the standard dialysis membrane, will increase the removal of beta2-microglobulin in~     chronic dialysis patients.~   "
228895|NCT00560950|"~     The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well~     tolerated and produces an immune response in older adults.~   "
209016|NCT00825110|"~     the principal research objective is to form a database of tissue samples from patients with~     colorectal (bowel) cancer. The tissue samples that will be used for this research will have~     already been taken for diagnostic or therapeutic reasons. We will also be asking for consent~     for a research blood sample. The database will be used to improve our understanding of the~     molecular genetics and gene expression patterns in colorectal cancer.~   "
209017|NCT00825097|"~     Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments~     may include physical therapy, orthosis, botulinum toxin (BTX) injections and selective~     neurotomy.~      Several RCT placebo-controlled studies have demonstrated improvement in spasticity, in pain~     and in active ankle dorsiflexion after BTX injections.~      Unfortunately, BTX is an expensive treatment and its effects last about three months.~      Selective neurotomy consists in a partial section of the motor nerve innervating spastic~     muscles responsible for the SEF, leading to a permanent treatment of the SEF.~      Until now, neurotomy has only been assessed by observational case-report studies and has~     never been submitted to a RCT.~      The aim of our study is to evaluate the benefits of selective tibial neurotomy in case of SEF~     according to the 3 domains of the ICF, by comparing it with BTX injections, among a~     prospective, randomized, controlled single blind study: it would allow to promote a permanent~     and cost-effective treatment in case of SEF.~   "
209018|NCT00825084|"~     This study is to characterize the pharmacokinetics of single and multiple oral doses of~     Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and~     tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. The~     secondary objective of this study is to compare the pharmacokinetics, safety and tolerability~     of single and multiple oral doses of Dimebon in Japanese and Western healthy subjects.~   "
209019|NCT00825071|"~     The investigators want to test the efficacy of these anesthetic antiemetic measures~     collectively with or without ondansetron or dexamethasone, in the prevention of postoperative~     nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy.~   "
209020|NCT00825058|"~     Primary objective :~        -  To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of~          SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent~          major depressive episode.~      Secondary objectives:~        -  To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess~          plasma concentrations of the active metabolite.~   "
209021|NCT00825045|"~     This study will provide information regarding dopamine D2/D3 occupancy related with~     clinical/adverse effects in older people with schizophrenia and schizoaffective disorder. The~     results of this study will also show an appropriate dose range in order to evade undesirable~     adverse effects while deriving therapeutic effects, which will directly serve to guide~     physicians in clinical practice. Furthermore, the findings of this study will elucidate~     mechanisms underlying older people's increased sensitivity to antipsychotic drugs. In~     addition, the contribution of D2 and D3 in mediating antipsychotic response will be~     contrasted, using 2 radiotracers, which has never been tested in an older population.~      The hypotheses are as follows: First, clinical response (i.e., a ≥ 20% decrease in the Brief~     Psychiatric Rating Scale total score) will be achieved in older patients with occupancy that~     is lower than the threshold of 60% in historical young controls. Second, prolactin elevation~     and EPS will be detected in older patients with occupancies that are lower than the~     thresholds of 72 and 78% reported in historical young controls. Third, dopamine D2 receptor~     occupancy will be inversely correlated with subjective well-beings. Fourth, the binding~     potential and receptor occupancy will be at least 20% lower with [11C]-(+)-PHNO than with~     [11C]-raclopride in the caudate/putamen. Fifth, the binding of [11C]-(+)-PHNO in the globus~     pallidus will be higher than that of [11C]-raclopride.~   "
209022|NCT00825032|"~     Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise~     training (UEET) in patients with chronic obstructive pulmonary disease (COPD).~      The theory supporting the inclusion of upper extremity exercise training in the pulmonary~     rehabilitation for these patients, is based on the profound understanding of the activity of~     the accessory respiratory muscles, which are competitively involved in both the support of~     the upper extremities during activities and the ventilation. However, a systematic review of~     the literature carried out by our staff reveals that the clinical trials carried out up to~     now to verify the effectiveness of UEET are of poor methodological quality and the~     investigators cannot corroborate the recommendation recently made on the basis of the results~     of the investigators' review.~      Therefore the investigators began this randomized, parallel groups, controlled clinical trial~     with the purpose of determining the short-term effect of unsupported UEET on the performance~     of the upper extremities and on symptoms perceived during activities by patients with COPD.~   "
209023|NCT00825019|"~     Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression~     rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment~     of patients with a recurrent major depressive episode (MDD).~      Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to~     placebo and to assess plasma concentrations of the active metabolite.~   "
209024|NCT00825006|"~     To investigate the hemodynamic, inter and intraventricular desynchrony effects of anodal~     stimulation and triple site pacing compared with the usual dual site pacing by~     echocardiography and Tissue Doppler Imaging.~   "
209038|NCT00824824|"~     We have completed a study in which we examined the response of the retinal circulation to~     changes in posture from sitting to lying down in patients with primary open angle glaucoma~     (POAG). This alteration in position produces changes in the local blood pressure at the~     entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating~     and constricting in order to maintain a steady blood flow rate. In an eye with POAG, this~     often does not occur. As a result, there are large fluctuations in blood flow which may~     produce the retinal neuronal damage associated with glaucoma.~      The purpose of this study is to demonstrate that topical anti-glaucoma treatments with agents~     that have vasoactive as well as IOP-lowering effects can have a beneficial effect on~     maintaining a steady retinal blood flow rate even when there are changes in local blood~     pressure.~   "
209039|NCT00824811|"~     Objective:~      To evaluate the safety and efficacy of topical cyclosporine eye drops (Restasis®) for the~     treatment of epiphora caused by canalicular stenosis secondary to Docetaxel (Taxotere®)~     treatment for various cancers.~   "
209025|NCT00824993|"~     The goal of this clinical research study is to see if ibandronate can help to slow the rate~     of bone loss that may occur in patients who have received a bone marrow transplant for blood~     cancer.~      This study plans to address the following hypotheses:~        1. The addition of Ibandronate initiated immediately after the transplantation will prevent~          bone loss in patients undergoing allogenic bone marrow transplantation (BMT) with~          underlying hematologic malignancies or hematologic disorders.~        2. BMT patients who require prolonged steroid and other immunosuppressive treatment for~          Graft versus Host Diseases(GVHD) have a higher rate of bone loss, which can be prevented~          or attenuated by Ibandronate.~      Specific objectives to test these hypotheses are:~        1. Primary Objective:~           1. To prospectively compare the bone mineral density changes of lumbar spine, femoral~          neck and total hip between patients randomly assigned to ibandronate and control group~          over 12 months post bone marrow transplantation at the University of Texas MD Anderson~          Cancer Center.~        2. Secondary Objectives:~             1. To measure and compare the accumulated level of steroid used in both treatment and~               control groups.~             2. To collect and compare the level of serum C-terminal telopeptide (CTX) in both~               treatment and control groups to monitor the bone turnover rate for the duration of~               the study.~             3. To conduct a cost-effectiveness analysis of participating patients for both~               outcomes on bone mineral density (measured data) and skeletal-related events~               (modeled data).~             4. To record incidence of bone fractures and the graft rate in both treatment and~               control groups.~   "
209026|NCT00824980|"~     The major objective of this study is to evaluate the therapeutic effect of a topical~     treatment simultaneously inhibiting Dipeptidyl Peptidase IV and Aminopeptidase N (IMTM~     #IP10.C8) in patients with mild to moderate psoriasis of the skin~   "
209027|NCT00824967|"~     Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in~     institutions for the elderly.~      Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in~     older people with a diagnosis of dementia.~   "
209028|NCT00824954|"~     Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study~     addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy~   "
209029|NCT00824941|"~     About 15 to 20 percent of individuals living in the United States have chronic abdominal~     pain, often of unknown origin, which is often difficult to diagnose and treat. One possible~     cause of chronic abdominal pain is an inflammation of the intestines, but it is not known~     whether the two are related. Furthermore, although overweight people tend to be more likely~     to have increased inflammation, it is not known whether there is a connection between~     increased body weight and chronic abdominal pain. This study will examine the relationship~     between symptoms of chronic abdominal pain and intestinal inflammation by comparing the~     medical test results of normal weight and overweight patients who have a history of chronic~     abdominal pain.~      This study will include 224 subjects, who must be men and women between the ages of 13 and~     45. Half the subjects will be healthy participants, and half will have had chronic abdominal~     pain of unknown origin for longer than 6 months. Female participants must take a urine~     pregnancy test before starting the study, and will not be allowed to participate if the test~     is positive. During the study, patients will visit the NIH Clinical Center on two occasions~     for testing.~      On the first visit, patients will provide a medical history, including information about~     current medications or natural remedies and tobacco and alcohol use, and will also fill out~     questionnaires to provide information about symptoms, current levels of gastrointestinal~     pain, and general quality of life. The study researchers will conduct a physical examination,~     measure patients height and weight, and draw blood for testing.~      Patients will be asked to not eat or drink anything for 8 hours before the second visit, and~     will be asked to bring a bathing suit and a swim cap to the Clinical Center. On the day of~     the visit, patients will fill out questionnaires to provide information about symptoms,~     current levels of gastrointestinal pain, and general quality of life. Patients will also~     provide a blood sample for testing. Researchers will measure patients blood pressure and~     heart rate, height, weight, waist/hip circumference, and intra-abdominal measurement.~     Patients will also be asked to put on the bathing suit and swim cap to have their body fat~     measured using a machine called the BOD POD. To test the gastrointestinal system, patients~     will then be asked to drink a sugar-based test solution, and researchers will collect all~     voided urine for the next 5 to 6 hours. (Patients may drink water during this time.)~      On either Day 1 or Day 2 of the study, patients will sip, swish and spit an additional sweet~     taste solution. Patients will sip, swish, and spit different concentrations of this sweet~     taste solution, for a total of 25 tastings of this solution. Subjects will then complete~     questionnaires about their sweetness preferences related to these 25 tastings.~   "
209030|NCT00824928|"~     To provide a systemic, uniform and user-friendly tool for collection of data on prostate~     cancer salvage cryotherapy in a multicenter setting. The goal is to learn more about the~     short and long term efficacy and safety of this procedure. Ultimately the data analysis will~     serve as a robust guidance instrument for improving upon the utilization of this procedure~     for the treatment of patients with recurrent (LRD) prostate cancer.~   "
209031|NCT00824915|"~     The purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA)~     upon commercial release.~   "
209032|NCT00824902|"~     The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound~     imaging software utilizing tissue elasticity measurements to identify tumor foci among men~     who will undergo radical prostatectomy for localized prostate cancer.~      As a secondary objective, investigators will compare elasticity measured tumor foci volume to~     the measured volume from radical prostatectomy pathologic examination.~   "
209033|NCT00824889|"~     Natural Killer (NK) cells play a unique role during innate immune responses as they are able~     to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as~     well as allogeneic cells.In a first time, we will characterize the tissue distribution, the~     phenotype and the effector functions of NK cells present in the human healthy skin.~   "
209034|NCT00824876|"~     The investigators want to investigate the effect of anaesthesia, on the ability to maintain~     upright posture immediately after surgery in mamma cancer patients.~      The investigators hypothesis is, that a standard anaesthesia does not effect the ability to~     maintain upright posture right after surgery.~   "
209035|NCT00824863|"~     Pityrosporum folliculitis presents as fine superficial follicular pustules and papules on the~     trunk and upper extremities. Ketoconazole 2% foam was recently approved for the treatment of~     seborrheic dermatitis in immunocompetent patients 12 years and older. Ketoconazole 2% foam is~     felt to work by reducing the number of pityrosporum yeast organisms. Safety and efficacy of~     ketoconazole 2% foam treatment for this fungal infections has not been established. This~     study is to demonstrate efficacy and safety in the treatment of pityrosporum folliculitis.~   "
209036|NCT00824850|"~     The purpose of this study is to assess the late immune response to further doses of~     pneumococcal conjugate vaccine more than 10 years after primary immunization with Prevnar~     (7vPnC) in infancy, as compared with individuals who did not receive Prevnar in infancy (the~     Prevnar naive cohort which received MnCC). The study will take place at a single study~     center. Study participants must have participated previously in a specific Wyeth Prevnar~     study (Study D118-P8) and must still be enrolled in the Northern California Kaiser Permanente~     (NCKP) health plan.~   "
209057|NCT00824577|"~     Use 24hr Holter ECG, ultrasound and cardiac fibrosis markers in the chronic kidney disease~     patients~   "
209040|NCT00824798|"~     Joint damage secondary to recurrent haemarthroses and chronic synovitis represents the~     commonest clinical manifestation of haemophilia. Incapacitating pain, loss of joint stability~     and mobility, axial deviation, deterioration and decreased function are the most frequent~     complains in patients with severe haemophilic arthropathy In this context, the purpose of our~     study is to examine and analyse specific changes in gait in patients suffering from~     haemophilic arthropathy and determine the impact on health-related quality of life in terms~     of conceptual components of pain and stiffness, psychosocial stress, disability, and activity~     limitations as recommended by the International Classification of Function (ICF) recently~     published by the World Health Organization.~   "
209041|NCT00824785|"~     To determine whether adding panitumumab, an antibody against the epidermal growth factor~     receptor (EGFR), to standard chemotherapy with epirubicin, oxaliplatin and capecitabine~     (EOX), improves the duration of survival of patients with advanced stomach and oesophageal~     cancer.~   "
209042|NCT00824772|"~     Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in~     dose requirements of fentanyl for postoperative pain control. This study aims to reveal the~     genetic factors affecting the variable requirements of fentanyl during postoperative period.~   "
209043|NCT00824759|"~     Tissue hypoxia is the only accepted trigger for erythropoietin (EPO) production. However, in~     healthy subjects EPO concentrations have also increased after oxygen breathing. The aim of~     our study is to confirm these observations.~      Besides its main function in erythropoiesis, EPO has also shown tissue protective effects.~     The second goal of our study is to observe the cardioprotective effects of increased~     endogenous EPO, induced after normobaric oxygen breathing.~   "
209044|NCT00824746|"~     A single arm, open label, prospective, phase II trial of Gefitinib retreatment for the~     advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And~     progressive disease should be observed with at least one prior regimen following previous~     gefitinib failure.~      Primary endpoint~        -  to assess Disease Control Rate (Remission + Stable disease)~      Secondary endpoints~        -  to assess the progression free survival~   "
209045|NCT00824733|"~     RATIONALE: Biological therapies, such as agatolimod, may stimulate the immune system in~     different ways and stop tumor cells from growing. Monoclonal antibodies, such as trastuzumab,~     can block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Giving agatolimod together with trastuzumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving agatolimod together with trastuzumab~     works in treating patients with locally advanced or metastatic breast cancer.~   "
209046|NCT00824720|"~     The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug~     delivery system in open-angle glaucoma or ocular hypertension.~   "
209047|NCT00824707|"~     This study is working to research the efficacy and significant of the anti-virus therapy in~     the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish~     treatment standards of anti-virus therapy in PLC.~   "
209048|NCT00824694|"~     To show that a structured treatment plan based upon Accu-Chek 360 View has a favorable effect~     on physician decision-making and HbA1c for patients on oral hypoglycemic agents (OHA) or~     insulin for type 2 diabetes (T2D).~      Hypothesis 1: Compared to controls, intervention subjects will undergo a greater number of~     medication changes and have a lower HbA1 at the conclusion of the study.~      Hypothesis 2: Higher rates of monitoring at entry will be associated with lower CHO~     consumption, lower percent body fat, higher medication compliance, and higher physical~     activity levels.~      Hypothesis 3: Patients with lower rates of monitoring at entry will have higher rates of~     depression, more likely to have an external locus of control, and express greater fear about~     self-testing.~   "
209049|NCT00824681|"~     The purpose of this study is to investigate the efficacy of music therapy in assisting with~     the coping and adjustment of children of adults with major burns. The investigators~     hypothesized that there will be a significant decrease in anxiety levels between those~     children who participated in music therapy compared to non-participants.~   "
209050|NCT00824668|"~     This trial is conducted in Europe. The aim of this clinical trial is to compare the 24-hour~     pharmacodynamics/ pharmacokinetics of biphasic insulin aspart 30 (BiAsp 30) thrice daily~     treatment with that of a basal-bolus treatment with insulin glargine and insulin glulisine in~     type 2 diabetic subjects.~      Pharmacodynamics is the glucose-lowering effect of the study medication over the entire~     observation phase from the time of administration and the efficacy period while the~     pharmacokinetics is the amount of the study insulin that can be determined in the blood.~   "
209051|NCT00824655|"~     The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate~     Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will~     also assess the immunological response (measure the amount of antibodies, i.e. proteins that~     fight off germs) produced by children after they have been given the 13-valent pneumococcal~     vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site~     will be assessed during the study.~   "
209052|NCT00824642|"~     The objective of this study is to investigate the effectiveness of Acu-TENS (Transcutaneous~     electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate~     and exercise performance on the subjects with exercise.~   "
209053|NCT00824629|"~     The purpose of this study is to evaluate two types of embryo transfer procedure.~      The investigators will compare direct embryo transfer against afterloading embryo transfer.~   "
209054|NCT00824616|"~     The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking~     insulin for Type 2 Diabetes.~   "
209055|NCT00824603|"~     The purpose of this study is to determine if a continuing medical education (CME) program can~     change primary care providers' use of insulin therapy - their confidence in selecting doses~     and engagement of patients in the decision making as to whether to initiate insulin therapy.~   "
209056|NCT00824590|"~     This study is to compare the pharmacokinetics of Dimebon in subjects with severe renal~     impairment to subjects with normal renal function after oral administration of a single oral~     20-mg dose of Dimebon. This study is also to assess the safety and tolerability of a single~     oral 20-mg dose of Dimebon in subjects with severe renal impairment and subjects with normal~     renal function.~   "
209058|NCT00824564|"~     Tranexamic acid has been shown to reduce postoperative blood losses and transfusion~     requirements in a number of types of surgery. Most trials in orthopedic surgery have been~     conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the~     effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture~     surgery, primarily fracture shaft of femur.~   "
209059|NCT00824551|"~     The blinded RCTstudy aims to:~        -  Determine the effects of HBOT on burns conversion for patients who have fresh thermal~          burns injury using the LDI.~        -  Objectively determine the proportion of burns conversion in areas of partial thickness~          burns for early thermal burns injury in both arms of the RCT.~        -  Study the effects of HBOT on immunological markers IL-1, IL-2, IL-4, IL-6, IL-8, IL-10,~          TNF-α and TGF-β ( comparison between both arms and 2 assessment points).~        -  Study the effect of HBOT on haematological markers including procalcitonin ,albumin,~          lymphocyte counts, neutrophil count, and macrophage count.~        -  Study the effects of HBOT on histology specimens in quantifying P53 protein, leukocyte~          and macrophage infiltration, burns depth assessment and vascular endothelial growth~          factor (VEGF) and inducible nitric oxide synthase (iNOS) .~        -  Study the effects of HBOT on bacteriology of tissue culture in areas of deep dermal~          burns.~   "
209060|NCT00824538|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     stage I, stage II, or stage III breast cancer who have tumor cells in the bone marrow.~   "
209061|NCT00824512|"~     The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus~     placebo in patients suffering from Friedreich Ataxia~   "
209062|NCT00824499|"~     The purpose of this study is to determine whether regional implementation of shared care with~     respect to type 2 diabetes is feasible, effective and cost-effective.~   "
209063|NCT00824486|"~     This project seeks to determine the efficacy of safety education using a safe home model. The~     4 X 8 ft. model is designed to look like a house; each of 4 rooms has a focused safety~     message. Families will be enrolled in the clinic and randomized to one of two groups, the~     safe home model group and the printed safety education materials (TIPP materials) group. The~     investigators will compare the retention of safety information among caregivers instructed~     using these two methods. The hypothesis is that families in the safe home model group will~     have improved retention of safety information.~   "
209064|NCT00824473|"~     The purpose of this study is to determine if one allergy medication (0.15% azelastine~     hydrochloride) is more effective than Placebo alone~   "
209065|NCT00824460|"~     The purpose of this study is to investigate the ability of different doses of PA21 to lower~     serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.~   "
209066|NCT00824447|"~     This study is designed to give additional information on the efficacy, safety and local~     effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during~     a second grass pollen season.~   "
209067|NCT00824434|"~     Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular~     ultrasound (IVUS) data for the PROMUS Element™ Everolimus- Eluting Coronary Stent System in~     the treatment of patients with a single de novo atherosclerotic lesion~   "
209068|NCT00824421|"~     This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as~     efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected~     patients who have not been previously treated with antiretroviral drugs.~   "
209069|NCT00824408|"~     The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with~     pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who~     relapsed after or failed first-line platinum based therapy.~      The secondary objectives are to identify the acceptable dose of BI 6727 in combination with~     pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727~     monotherapy arm is closed to further recruitment.~   "
209070|NCT00824395|"~     The purpose of this research study is to investigate the genetic causes of diabetes.~     Specifically, we are interested in the mitochondrial genome and how variants in the~     mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome.~   "
209071|NCT00824382|"~     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL~     inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese~     patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum~     dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic~     evaluations.~   "
209072|NCT00824369|"~     The purpose of the protocol is to assess long-term safety and tolerability of subjects who~     discontinue for any reason from UK-453,061 qualifying studies.~   "
209073|NCT00824356|"~     This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of~     two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an~     allergen challenge chamber in male subjects with seasonal allergic~   "
209074|NCT00824343|"~     This is a single arm phase II trial to study the efficacy and safety of a Cdk inhibitor~     P276-00 in the treatment of squamous cell carcinoma of head and neck. Patients with recurrent~     or metastatic disease that is unresectable and incurable by radiation will be enrolled.~     Thirty eight evaluable patients need to be enrolled in the study. All patients will receive~     protocol treatment i.e. P276-00 as an intravenous infusion from day 1 to day 5 and from day 8~     to day 12 in each 21 day cycle till progression of disease or unacceptable toxicity. Safety~     evaluations by means of recording vitals, physical examination and lab investigations like~     hematology and clinical chemistry will be undertaken at regular intervals in each cycle.~     Tumor measurements by spiral CT scan will be undertaken at baseline and at the end of every 2~     cycles for response evaluation by RECIST criteria. All patients will be followed up for~     survival status till one year of cycle 1 day 1.~   "
209075|NCT00824330|"~     Older persons with diabetes have a harder time maintaining blood pressure when standing up.~     When blood pressure drops when standing up, fainting may occur. This study will see how~     regular exercise can improve the ability of the body to keep blood pressure up when standing.~     We want to see how this improvement varies with a home-based walking program.~   "
209077|NCT00824304|"~     The hypotheses of this study are:~        1. Compared to children who received a placebo, children who received iron or zinc or iron~          and zinc combined will perform better on cognitive tests and will have better growth~          status at ages 8 to 10 years.~        2. Compared to children who received iron or zinc alone, children who received iron and~          zinc combined will perform differently on cognitive tests and will have different growth~          status at 8 ages 8 to 10 years~        3. Compared to children who had poorer iron and zinc status or poorer growth status before~          and after supplementation during infancy, children who had better iron and zinc status~          or better growth status before and after supplementation during infancy will perform~          better on cognitive tests and will have better growth status at ages 8 to 10 years.~        4. Compared to children who have lower iron and zinc status, poorer growth status, or low~          animal source intake at ages 8 to 10 years, children who have higher iron and zinc~          status, better growth status, or high animal source intake at ages 8 to 10 years will~          perform better on cognitive tests and will have better growth status.~   "
209078|NCT00824291|"~     This is a multicenter study to assess the health and well-being in subjects who are~     outpatients with major depressive disorder that take desvenlafaxine succinate sustained~     release (DVS SR) or placebo for 12 weeks.~   "
209079|NCT00824278|"~     Medical illnesses and treatments can cause distress in patients, and medical professionals~     are very interested in identifying distress quickly to ensure that a patient can receive~     appropriate support and treatment. Adult patients often use a screening tool known as the~     Distress Thermometer to indicate the causes and levels of distress they feel. However, little~     work has been done on how to assess distress in pediatric patients. This study will~     investigate the effectiveness of the Distress Thermometer as a tool to accurately measure~     distress in pediatric patients, and determine whether primary caregivers and physicians can~     also use the Distress Thermometer to accurately gauge a patient s levels and sources of~     distress. The study will also investigate the effectiveness of the Distress Thermometer~     compared with other means of measuring fatigue, mood, and pain levels.~      This study will include approximately 90 patients between 7 and 21 years of age who are~     currently enrolled in a National Institutes of Health pediatric research study. It will also~     include responses from the primary caregivers and primary medical providers of the patients~     involved in the study.~      All patients will complete the Distress Thermometer s self-reported distress scale and other~     standardized measures of anxiety, depression, fatigue, and pain. In addition, patients~     between 18 and 21 years of age will be asked to assess the benefits and negative effects of~     participating in psychosocial research.~      On the same day, the patient s primary caregiver and primary medical provider will complete a~     Distress Thermometer survey to estimate the patient s distress level. If either the patient~     or the primary caregiver indicate high levels of distress or mood symptoms, the researchers~     will offer them an opportunity to speak with a mental health professional. The primary~     medical provider will also receive a copy of the responses reported on the patient s Distress~     Thermometer.~   "
209080|NCT00824265|"~     The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to~     fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).~   "
209081|NCT00824252|"~     The goal of this research study is to look at social and relationship factors that may affect~     the quality of life of patients with head and neck cancer and their spouses.~   "
209082|NCT00824239|"~     Sedation is very important in critical care. Critically ill patients are submitted to many~     stressor factors that have potential to affect longterm outcomes. However, oversedation is~     associated with increased morbidity, including increased time of mechanical ventilation and~     ICU stay and longterm psychological complications. Daily interruption of sedation is~     associated with less time under mechanical ventilation and less posttraumatic stress~     disorder. Intermittent sedation, when compared with continuous sedation, is also associated~     with decreased time of mechanical ventilation. The aim of this study is to compare~     intermittent sedation with daily interruption. Our primary endpoint is free-days of~     mechanical ventilation in 28 days.~   "
209083|NCT00824226|"~     Study hypothesis: supplementary magnesium may influence the blood calcium level in treated~     hypoparathyroid patients. Patients will be treated with supplementary magnesium (350 mg/day)~     for 3 weeks. Calcium and other relevant blood parameters will be measured before the~     treatment, at the end of treatment and 2 weeks after stopping treatment.~   "
209084|NCT00824213|"~     The investigators propose to investigate the performance of the image reconstruction software~     with resolution recovery correction for bone SPECT studies. The investigators estimate that~     in only 30 minutes, using this new technique of collimator de-blurring, one could perform a~     fully 3-dimensional SPECT whole-body bone study, essentially obviating the necessity for~     doing planar bone studies.~      In the scope of the proposed project, the investigators group aims to test the hypothesis~     that one can perform a Tc-99m whole-body SPECT study in the same time as a regular routine~     planar bone study, with greater localization accuracy, and greater lesion detection.~      To establish a gold standard necessary to assess the performance of the SPECT bone scans,~     the investigators will compare number of malignant lesions detected in patients who are~     proven to have metastatic skeletal bone lesions on PET F-18 whole-body scans, with whole-body~     Tc-99m SPECT lesions. The investigators also propose to compare the detection of SPECT scans~     with standard planar bone scans. This will allow for two major comparisons (a) the accuracy~     of SPECT bone studies compared to planar bone studies, and (b) the accuracy of SPECT bone~     scans compared to F-18 PET studies. Most prior studies purporting to show the superiority of~     F-18 bone scans to Tc-99 bone scans were done only against either planar scans or a~     combination of planar scans and partial SPECT studies over the spine. We anticipate that F-18~     bone scans, due to the higher counting statistics of PET agents, will show more lesions than~     SPECT, but the exact increase in sensitivity has never been compared to whole-body SPECT~     scans.~   "
209085|NCT00824200|"~     Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom.~     Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy~     for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations~     of multiple drugs could be used, many individuals wish to take fewer medications.~      Participants in the BEDTiMe Nocturia Study will undergo a series of visits during which they~     will receive a combination of either standard drug therapy (or placebo) and a behavioral~     intervention tailored to help with nocturia or problems with nocturia. Participants will be~     evaluated for outcomes at 12 weeks and followed for six months.~      This study will yield important information related to alternative treatments of nocturia in~     men, as well as novel information regarding the clinical importance of these nocturia~     reductions. This study has the potential to alter standards of care.~   "
209086|NCT00824187|"~     The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo~     in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).~   "
209238|NCT00822185|"~     This trial is conducted in Japan. The aim of this trial is to assess the safety and~     tolerability of activated recombinant human coagulation factor VII analogue (NN1731,~     vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the~     pharmacokinetics of NN1731 will be examined~   "
209087|NCT00824174|"~     Objectives:~      The purpose of this study is to obtain descriptive information about the nature and extent of~     body image concerns among surgical patients with head and neck cancer, satisfaction with care~     received regarding body image issues, and interest in psychosocial services targeting body~     image disturbance. Findings from this study provide important preliminary data to guide~     future large scale research on the critical, yet understudied, psychosocial issue of body~     image functioning for head and neck cancer patients. Information obtained from this study can~     specifically be used to facilitate the development of appropriate disease-specific body image~     instruments and to determine the need for body image focused psychosocial interventions to~     enhance quality of life and the survivorship experience for these patients.~      Primary Aims~        1. To characterize the nature and extent of body image concerns in surgically treated~          patients with head and neck cancer and determine preferences for psychosocial~          intervention.~        2. To compare body image and quality of life outcomes for patients at different time points~          relative to initiation of treatment. Specific time points of interest are pre-treatment,~          within one year of initial surgical treatment, and greater than 1 year following initial~          surgical treatment.~      Secondary Aim~      1. To compare body image and quality of life outcomes for patients with oral cavity,~     cutaneous, and midface cancers.~   "
209088|NCT00824161|"~     The purpose of this study is to evaluate progression free survival primarily. The secondary~     objectives are to evaluate the antitumor activity, as assessed by objective tumor response,~     duration of clinical benefit, overall survival, and the safety profile of TAS-109~   "
209089|NCT00824148|"~     The purpose of this study is to determine whether a real-time continuous glucose monitoring~     system is able to improve HbA1c in patients suffering from type 1 diabetes compared to~     conventional finger prick glucose measurements. In addition it will investigate whether~     number of episodes with serious hypoglycemia is changed in those same patients, and whether~     quality of life (health status and treatment satisfaction) increases.~   "
209090|NCT00824135|"~     Patients with refractory hematologic malignancies including those who develop recurrent~     disease after allogeneic hematopoietic stem cell transplantation (HSCT) have a dismal~     prognosis. Historically, both regimen-related mortality and disease recurrence have been~     significant causes of treatment failure in this heavily pre-treated patient population. The~     investigators institution has utilized mismatched family member donors for these patients for~     several reasons: (1) Only 30% of patients have matched related donors available; (2)~     transplantation can be performed more rapidly since the time to unrelated donor~     trans-plantation averages 3 to 4 months; (3) the alloimmune reactivity of natural killer (NK)~     cells following haploidentical HSCT has been shown to reduce relapse rates in certain patient~     groups; and, (4) no other curative treatment options are available.~      In the present trial, the investigators propose a novel conditioning regimen using~     clofarabine in an effort to enhance cytotoxicity while simultaneously reducing regimen~     related toxicity. In this phase I trial, the goal is to determine the maximum tolerated dose~     (MTD) of clofarabine when used in combination with melphalan and thiotepa pre-transplant.~   "
209091|NCT00824122|"~     This study proposes to identify patients who developed RMS with vancomycin infusion, and~     determine presence or absence of variant alleles involved in histamine biotransformation. The~     implications of this study are important, as identification of variant alleles in these~     patients, may alter the current standard of care for vancomycin infusions.~      The hypothesis of this study is that the development of red man syndrome (RMS) during receipt~     of intravenous vancomycin is associated with the presence of variant alleles for genes~     involved in the histamine pathway. The primary outcome that will be measured will be the~     history of RMS and the presence or absence of variant alleles for the genes responsible for~     histamine metabolism (i.e. histamine n-methyltransferase and diamine oxidase). As a secondary~     endpoint, the study will also attempt to determine the incidence of RMS in pediatric~     patients.~   "
209092|NCT00824109|"~     The purpose of this prospective trial is to demonstrate the safety and performance of the~     Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive~     diseases of the abdominal aorta.~   "
209093|NCT00824096|"~     Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine~     guidelines for extubation may be obtained through this study.~   "
209094|NCT00824083|"~     The purpose of the study is to assess the functional outcome, quality of life and late~     sequelae in a representative sample of 600 long-term survivors of Ewing sarcoma and to build~     a unique clinical and functional data pool of the underlying cohort of 3000 Ewing sarcoma~     patients with a follow-up of 3 decades.~   "
209095|NCT00824070|"~     This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or~     gatifloxacin in aqueous humor samples collected following topical instillation of the~     associated formulation in subjects undergoing cataract surgery.~   "
209096|NCT00824057|"~     The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on~     the blood levels of midazolam and caffeine in healthy volunteers~   "
209097|NCT00824044|"~     The purpose of this research study is to find out if a test can predict whether someone with~     depression will get better with treatment. We also want to find out whether there are changes~     in the brains of depressed patients having different types of treatment (drug therapy vs.~     talk therapy). We hope that a test called QEEG (Quantitative Electroencephalogram) can tell~     us if a treatment is going to work, even before the person starts to feel better.~      Hypothesis 1: Response to treatment will correlate with changes in QEEG metrics.~      Hypothesis 2: QEEG parameters, different from those that predict response to pharmacotherapy,~     will be associated with response to CBT.~   "
209098|NCT00824031|"~     Non-interventional, multicenter, cross-sectional study to evaluate the mental care received~     by schizophrenic patients and their caregivers in Spain irrespective of the drug prescribed.~   "
209099|NCT00824005|"~     Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all~     people with CAD are eligible for today's standard treatments. One new treatment approach uses~     stem cells—specialized cells capable of developing into other types of cells—to stimulate~     growth of new blood vessels for the heart. This study will determine the safety and~     effectiveness of withdrawing stem cells from someone's bone marrow and injecting those cells~     into the person's heart as a way of treating people with CAD and heart failure.~   "
209100|NCT00823992|"~     This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared~     to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with~     metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once~     weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their~     prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will~     be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly)~     The anticipated time on study treatment is 12 months, and the target sample size is 100-500~     individuals.~   "
209101|NCT00823979|"~     This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir~     and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as~     etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase~     inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral~     drugs and have NNRTI resistance mutations.~   "
209102|NCT00823966|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the~     incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect~     the safety and/or efficacy of this drug.~   "
209103|NCT00823953|"~     Diabetes is a common disease which has been treated by traditional medicines for centuries~     before modern medicine became available. A very common remedy for Diabetes Mellitus in~     different cultures is momordica charantia (karela or Bitter gourd). The use of alternative~     medicine is common among Pakistani population. This study was planned to find out the effect~     of administering freeze dried powder of momordica charantia for three weeks on the glycemic~     profile and insulin resistance of treatment naiive patients with mild Type 2 diabetes.~   "
209104|NCT00823940|"~     The study will investigate whether GSK1362885 is safe and well-tolerated when administered to~     normal healthy subjects. The study will also measure blood levels of the study drug to~     determine how the body processes the drug (pharmacokinetics) and what effects the drug has on~     the body (pharmacodynamics).~   "
209105|NCT00823927|"~     This study is being done to examine lung function changes in individuals with HIV infection~     and to understand why individuals with HIV have increased risk of lung damage from cigarette~     smoking.~   "
209106|NCT00823914|"~     Objective of the study is to create and validate Chronic Quality of Life (CQOL) index that~     explores habits, career paths and other life choices psoriasis patients make as a result of~     coping with their disease that may not be impacted by therapy implemented at a given point in~     time.~      - The investigators think this data will show that patients who were diagnosed at a young age~     will have worse chronic quality of life.~   "
209107|NCT00823901|"~     The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin~     0.025% Gel are effective and safe in the treatment of papulopustular rosacea.~   "
209108|NCT00823888|"~     The overall objective of this project is to determine whether the provision of a pneumatic~     knee brace in patients with medial knee osteoarthritis (OA) improves knee mechanics.~     Secondary objectives will be to assess if the brace relieves knee pain and improves function.~     We will test the hypothesis that compared to the control treatment (see below for the~     definition) the use of a pneumatic knee brace is effective in medial knee OA.~   "
209109|NCT00823875|"~     Randomized, control, open label, multicentre clinical study. The patient who are in~     accordance with subject inclusion and exclusion criteria will be randomized to A group:~     Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment +~     Probucol; D group: Routine treatment+ Cilostazol+ Probucol .~   "
209110|NCT00823862|"~     To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101~     alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.~   "
209111|NCT00823849|"~     1. To evaluate the efficacy of Cilostazol and Probucol alone and in combination on~          atherosclerosis related biomarker~        2. To evaluate the safety of Cilostazol and Probucol alone and in combination on~          atherosclerosis related biomarker~   "
209112|NCT00823836|"~     To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole~     immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa~     in a double-blind, parallel group comparison study.~   "
209113|NCT00823823|"~     It is recognized that fractures of the distal radius and forearm occur in approximately one~     in 100 children and adolescents every year. Though closed manipulation and cast~     immobilization of displaced injuries is the mainstay of treatment in the majority of cases,~     the optimal type of cast remains debatable. Though well-molded casts theoretically provide~     the best ability to maintain fracture alignment, risks of circumferential immobilization in~     acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce~     these risks, but the effect on fracture stability is unknown. The proposed investigation~     seeks to address the simple question of whether circumferential or bivalved casts provide the~     best outcomes.~   "
209114|NCT00823810|"~     Measuring tumor response to treatment based on computed tomography (CT) and/or magnetic~     resonance imaging (MRI) has been a widely debated issue (response criteria in solid tumors~     [RECIST] and World Health Organization criteria). Furthermore, early identification of~     nonresponding patients is of great importance because the rates of response of common~     malignant solid tumors to chemotherapy are in the range of only 20-30%. Therefore,~     quantitative imaging of tumor metabolism with 18F-FDG PET/CT may provide important advantages~     and thus reduce side effects and costs of ineffective therapy. However, the evidence to date~     for the use of 18F-FDG-PET/CT with this indication is limited.~      The purpose of the present trial is to determine the impact of 18F-FDG PET/CT in the~     management of advanced colorectal cancer. The aim is also to confirm whether a metabolic~     response can be used as a surrogate end point in monitoring treatment response in this cancer~     type.~      The study consists of 40 patients with advanced colorectal cancer patients. All patients will~     be studied with 18F-FDG PET/CT combined with diagnostic contrast enhanced abdominal CT before~     the start of chemotherapy and re-evaluated 4-5 weeks after the initiation of therapy. Effect~     of this metabolic and anatomic change in therapy are evaluated and correlated to survival,~     morbidity, and treatment -related costs. Histopathologic confirmation of response is~     evaluated whenever possible. The data will be collected between 2008 and 2012.~   "
209115|NCT00823797|"~     This phase II trial studies how well bendamustine hydrochloride works in treating patients~     with anaplastic glioma or glioblastoma that has come back (recurrent) or growing, spreading~     or getting worse (progressive). Drugs used in chemotherapy, such as bendamustine~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing.~   "
209116|NCT00823784|"~     Haemorrhoids have, in literature, extremely high ranges of prevalence, 4,4% to 36% and there~     is a debate on the best treatment for III degree hemorrhoids. The Stapled Hemorrhoidopexy is~     indicated in grade III haemorrhoids due to its advantages vs. other techniques in pain~     reduction and time before resume of normal activity. The new technique of Doppler guided~     trans-anal arterial ligation (THD) appear to be another important therapeutic tool thanks to~     its scarce complications, the minimally invasive procedure and efficacy of the short term~     results. The rationale of the two surgical techniques is different: in fact, the Stapled~     Hemorrhoidopexy is based on the hypothesis that the mucosal and sub/mucosal resection and~     stapling can cure the prolapse, etiologic factor of haemorrhoids; on the other hand, the~     interruption of the arterial inflow of hemorrhoids by THD reduces hemorrhoidal tissue. Aim~     of this study is to compare 2 techniques: The doppler guided transanal haemorrhoidal~     dearterialisation with the THD device and the stapled Haemorrhoidopexy (according to Longo)~     for III degree (Goligher) haemorrhoid, not regarding the number of prolapsed piles~   "
209117|NCT00823771|"~     This is a pilot study assessing the role of the general practitioner in performing follow-up~     reviews on men who have recently completed radical radiotherapy for prostate cancer. This~     will be measured primarily by assessing any changes to the patient's health-related quality~     of life which will be evaluated by the completion of questionnaires by the participant at~     each review visit. The study aims to confirm that patient outcome is identical, independent~     of whether follow-up is performed by a specialist or the patient's General Practitioner.~   "
209118|NCT00823758|"~     Introduction to Study Objectives:~      In a joint collaboration of the Centers for Education and Research on Therapeutics (CERTS) at~     The University of Pennsylvania and the M.D. Anderson Cancer Center, this study proposes to a)~     combine detailed but under-utilized existing large datasets and b) collect new primary data;~     together, resulting two data resources will advance our ability to describe, study, and~     understand the effectiveness and safety of pharmaceuticals received by pediatric patients in~     hospitals, and how to improve the safe use of over-the-counter (OTC) acetaminophen in home~     settings.~      The CERTS study is organized into two projects: Project I and Project II.~      For this protocol, the study focus will be Project II-Phase 1.~      Project II will seek to qualitatively describe the patterns of use and misuse of~     over-the-counter OTC acetaminophen, through information gathered from consumers of various~     age groups, as well as professional key informants.~      Project II-Phase 1~      Objective 1:~      -Qualitatively explore knowledge, attitudes, beliefs, and practices regarding adult and~     adolescent self-administration of OTC acetaminophen, and parental administration of OTC~     acetaminophen to children.~      Objective 2:~      -Qualitatively explore experiences and practices of key professional informants, including~     physician and pharmacists, with respect to communicating information on the administration~     and risks of OTC acetaminophen to consumers and patients.~   "
209119|NCT00823745|"~     This is a phase 1 study to assess the routes of elimination of a single oral dose of [14C]~     PF-00868554 and to characterize the metabolic profile following single dose administration.~   "
209120|NCT00823732|"~     RATIONALE: Palliative care may be more effective than standard care in improving quality of~     life and symptoms in patients with lung cancer.~      PURPOSE: This clinical trial is studying the effects of palliative care on quality of life~     and symptom control in patients with stage IIIB or stage IV non-small cell lung cancer that~     cannot be removed by surgery.~   "
209121|NCT00823719|"~     The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in~     combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine,~     cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory~     diffuse large B cell lymphoma (DLBCL) who are eligible for autologous stem cell transplant.~   "
209122|NCT00823706|"~     The primary purpose of this study is to assess the prevalence of asymptomatic chronic angle~     closure in high risk Caucasian individuals, namely those with hyperopia. A secondary purpose~     is to assess whether specific demographic or ocular-anatomic parameters in this population~     are associated with a higher risk for angle closure.~   "
209123|NCT00823693|"~     The purpose of this study is to determine whether Bimosiamose Cream is safe and effective in~     the treatment of plaque type psoriasis.~   "
209124|NCT00823680|"~     This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients~     with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization~     period for glucose control, patients will be randomized to one of 5 groups to receive~     a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po~     qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is < 3 months,~     and the target sample size is 100-500 individuals.~   "
209125|NCT00823667|"~     RATIONALE: Palliative care may be more effective than standard care in improving quality of~     life and symptoms in patients with lung cancer.~      PURPOSE: This clinical trial is studying the effects of palliative care on quality of life~     and symptom control in patients with stage I, stage II, or stage IIIA non-small cell lung~     cancer that can be removed by surgery.~   "
209126|NCT00823654|"~     The purpose of this study is to see how the cancer treatment affects the ovaries. Cancer~     treatment can make it hard for a person to conceive a child in the future. It may also bring~     on early menopause. We will check blood levels of hormones that the ovaries produce. We will~     do this before, during, and after the cancer treatment. We will also ask the patient to fill~     out questionnaires about their menstrual cycle (periods) and information about your health~     and pregnancies. This may help us learn which women will be more likely to have early~     menopause.~   "
209150|NCT00823342|"~     For chronic HBV infection, an optimal pharmacological agent to promote recovery from chronic~     HBV infection would be one that inhibits HBV DNA polymerase, combined with the clearence from~     the liver of cccDNA to block HBV reactivation after the circulating viral burden has been~     eliminated by therapy. The activity of clevudine on cccDNA in combination with its potent~     antiviral activity on HBV polymerase makes it the optimal agent in combination with tenofovir~     for this protocol.~   "
209127|NCT00823641|"~     An open-label, non-randomised, uncontrolled, proof-of-concept study of eight patients with~     'definite' HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Eligible~     patients will have either early disease (of less than 2 years duration) or progressive~     disease (with observed clinical deterioration during the preceding 3 months.~      Following 2 baseline assessments including Magnetic Resonance Imaging (MRI) of the spinal~     cord and a lumbar puncture for examination of the fluid around the brain (CSF) participants~     will be treated with a total of 7 infusions of the anti-TNF-alpha antibody infliximab over a~     period of 48 weeks. After the last on therapy assessment at 48 weeks participants will be~     followed up for a further 24 weeks. Study assessments will be clinical, virological,~     immunological and radiological. MRIs of the spinal cord will be obtained at weeks 12 and 72.~     CSF will be examined, on therapy, at week 12.~   "
209128|NCT00823628|"~     In the treatment of coronary heart disease which is the major cause of heart attack, direct~     mechanical treatment with catheters such as the coronary angiography, coronary balloon~     intervention and stenting intervention are the mainstay of therapy in recent years. In that~     procedures, the investigators should use the contrast media, and it may cause kidney toxicity~     especially in the patients with underlying kidney disease and decreased kidney function. The~     investigators intended to find out which contrast agent has less kidney toxicity in the~     catheter based treatment of coronary arterial diseases in patients with underlying decreased~     kidney function~   "
209129|NCT00823615|"~     The purpose of this trial is to compare the performance of two multifocal contact lenses.~   "
209130|NCT00823602|"~     Literature suggests that GnRH antagonists are comparatively more often used in cycles which~     have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder~     patients. Up to now, however not enough prospectives have been published to prove any~     beneficial effect of antagonists on the first cycle assisted reproductive technique.~      This prospective study will do to evaluate the efficacy of gonadotropin releasing hormone~     antagonist in comparison with the standard long protocol in the first cycle of ART.~      The investigators will randomize 160 patients undergoing ART for the first time . Group 1~     (n=80) was stimulate with a standard long protocol and group 2 (n=80) stimulated with GnRH~     antagonist and then result of ART compare in two group .~   "
209131|NCT00823589|"~     Ageing is associated with vulnerability against infections leading to increased morbidity~     with risk of death. Innate and adaptive immunities are altered with ageing responsible of~     deficits in immune response against pathogens and after vaccination, and favouring the~     elderly vulnerability against a new pathogen with increased bacterial, viral, and fungal~     infections.~      If immunity has been widely studied in immunosenescence, there are few prospective,~     comparative studies with elderly ill patients. Moreover among these studies, pathologies are~     not well defined.~      The main objective of our project is to compare the immune state of elderly hospitalised~     subjects in an acute geriatric unit to the immune state of elderly healthy subjects selected~     with strict criteria, in order to precise the impact of polypathology and of various~     pathologies on immunity state.~   "
209132|NCT00823576|"~     Because local anesthetic infiltration has not been comparated to continuous infusion after~     spine fusion surgery, the investigators designed this study to determine whether this~     technique could enhance analgesia and improve patient outcome after posterior lumbar~     arthrodesis.~      The Main Objective of the study is to compare the evolution of the postoperative levels of~     pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an~     infiltration single shot of local analgesic (Ropivacaïne), one receiving a single shot~     infiltration and a continuous infiltration of Ropivacaine during 48 hours.~      In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL,~     and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.~      The secondary outcomes are the consumption of morphine,the rate of the nausea and the~     postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration~     of hospital stay and the persistence of residual pain.~   "
209133|NCT00823563|"~     This is a research study evaluating possible causes of chest pain (or an anginal equivalent,~     such as fatigue resulting in a decrease in exercise tolerance, shortness of breath, or back,~     shoulder, neck, or jaw pain) in people with no evidence of significant coronary artery~     disease on their coronary angiogram (pictures of the blood vessels in the heart). The purpose~     of the research study is to determine if there is diffuse atherosclerosis (plaque) not~     appreciated by angiography, or if the coronary endothelium (lining of the blood vessels in~     the heart) and/or microcirculation (small vessels in the heart that are not easily seen with~     an angiogram) are not functioning properly in those who have chest pain (or an anginal~     equivalent), but normal coronary arteries on angiography. Specifically, we are interested if~     these findings are more common in women than men.~   "
209134|NCT00823550|"~     This is a randomized, open label, phase IV, multicenter study for efficacy and safety of~     lamivudine versus entecarvir therapy in HBV-related advanced liver disease patients with high~     viral load and normal or slightly elevated transaminase.~   "
209135|NCT00823537|"~     Power-assisted therapeutic electrical stimulation (TES) or conventional TES to upper~     extremities in acute stroke patients were performed in a randomized controlled trial. The~     changes in finger and hand function will be evaluated. The hypothesis is that a~     power-assisted TES is more effective than a conventional TES.~   "
209136|NCT00823524|"~     RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell~     transplant may help kill any remaining cancer cells after the transplant.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural~     killer cells when given after a donor stem cell transplant in treating patients with advanced~     cancer.~   "
209137|NCT00823511|"~     This transmission pilot study is a prospective study to determine feasibility of enrolling~     female partners into an international transmission study. Companion study to MCC-13930.~   "
209202|NCT00822653|"~     For the end stage renal disease (ESRD) patients undergoing hemodialysis treatment,~     specifically, reflex mediated calf muscle pump stimulation has the potential to significantly~     reduce the number and magnitude of hypotensive episodes thus enhancing the effectiveness of~     the dialysis process. Fewer hemodialysis complications during the patient's hemodialysis~     treatment, would allow treatment sessions to continue to the prescribed volume removal, with~     much reduced patient recovery time, and the costs associated with this recovery.~   "
209138|NCT00823498|"~     The aims of the proposed study are to:~        1. Examine how youth and their parents use and perceive three active living domains for~          physical activity (PA): schools, recreation, and transportation environment;~        2. Identify patterns and predictors of environmental perceptions of physical activity;~        3. Compare and contrast youth evaluations of physical activity resources with research team~          objective evaluations of physical activity resources;~        4. Using above data, refine the conceptual framework of physical activity phenomena in~          low-income minority communities guiding this research and develop items for a~          quantitative survey measuring parental and youth environmental perceptions of physical~          activity for a future trial with this population.~   "
209139|NCT00823485|"~     The purpose of this study is to determine the impact of in situ fibrinolysis on the mortality~     at 30 days in case of subarachnoid hemorrhage.~   "
209140|NCT00823472|"~     Background of the study:~      Milder stimulation protocols have the advantage of being less expensive and more~     patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to~     lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild~     stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates~     have shown to be similar possibly because embryo quality outfavours embryo quantity.~      Objective of the study:~      The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead~     to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH~     antagonist co-treatment started on a fixed day.~      Study design:~      Prospective randomized trial comparing two different starting days of ovarium stimulation~     (day 2 versus day 5) for IVF treatment.~      Intervention:~      One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The~     other group will start on cycle day 5. Both group will start suppressing the gonadotrophin~     production of the the pituitary gland on cycle day 6 with a GnRH antagonist.~      Primary study parameters/outcome of the study:~      Primary outcome parameter is number of top embryos per ovum pick up.~      Secondary study parameters/outcome of the study:~      Secondary outcome measures are duration of stimulation, cancellation rate, fertilization~     rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number~     of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.~   "
209141|NCT00823459|"~     A single-arm, one-stage phase II trial of RAD001 will be undertaken. Sixty patients will be~     enrolled. The target population will be patients with a diagnosis of low-grade glioma who~     experience a recurrence and who undergo a biopsy or subtotal resection at the time of~     recurrence with pathologic evidence of recurrent glioma. The purpose of this study is to~     accrue patients to evaluate a pharmacologic agent. The study drug RAD001 will be~     self-administered (by the patients themselves). RAD001 will be administered orally as once~     daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of~     disease or unacceptable toxicity.~   "
209142|NCT00823446|"~     The purpose of this study is to perform a preliminary evaluation of the safety of Revera~     Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.~   "
209143|NCT00823433|"~     Pregnant,laboring women will receive 2 grams of oral penicillin V before delivery. At the~     time of delivery of the infant, umbilical vein cord blood will be obtained from the umbilical~     cord. These cord blood samples will be sent for bioassay of penicillin levels.~   "
209144|NCT00823420|"~     A single centre randomised controlled trial investigating the influence of a novel~     prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of~     oocytes~   "
209145|NCT00823407|"~     The purpose of this study is to investigate the pharmacological and cognitive effects of MDA~     in healthy humans.~   "
209146|NCT00823394|"~     The goal of this research study is to learn if certain factors may affect cancer rates among~     African Americans. These factors include behavioral, social, and environmental factors~     including diet and physical activity, cigarette smoking, cancer screening, health care,~     neighborhood environment, and mental health.~   "
209147|NCT00823381|"~     The purpose of this study is to compare the effects of the antioxidant resveratrol to a~     diet intervention (Calorie Restriction) to determine how each of them affects the following:~     gene expression profile, cholesterol (lipids), how well the hormone insulin works to control~     your blood sugar, and other blood and tissue markers of metabolic and cardiovascular health.~      Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have~     health benefits such as improving fat metabolism, insulin action, and possibly extending~     lifespan. Resvida™ is the name for the dietary supplement containing the natural antioxidant~     resveratrol. Resvida™ will be supplied by DSM Nutritional Products, Ltd.~      Resvida™ is considered a dietary supplement, and therefore it is not an approved drug by the~     Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug~     Administration does not strictly regulate herbs and dietary supplements. The makers of~     Resvida™ make no claim that this supplement is meant to treat any ailment.~      Calorie restriction (CR) is a low calorie diet (about 30% fewer calories than the American~     Dietetic Association (ADA) recommends). Calorie restriction has also been linked to health~     benefits (enhanced cardiovascular and metabolic health) and an extended lifespan.~      This study is designed to compare the health benefits of both resveratrol and CR and to~     determine if resveratrol mimics some of the health benefits shown with CR.~   "
209148|NCT00823368|"~     The subjects that meet the inclusion and exclusion criteria and consent to participate in~     protocol 22001 will be offered participation in 22001A which will evaluate secreted protein~     before and after treatment with STX209 and placebo to determine if they correlate with~     effectiveness of treatment or susceptibility to treatment with STX209. These same subjects~     will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection.~     The investigators will study the DNA to determine if STX209 works better in people with~     specific gene variations, or to find new gene variations that predict how well STX209 works.~   "
209149|NCT00823355|"~     Primary objectives are to evaluate the safety profile and tolerability of oral BCX1777 in~     each cohort of patients with recurrent or refractory T/NK-cell malignancies and to evaluate~     pharmacokinetics (PK) of oral BCX1777.~   "
209203|NCT00822640|"~     A population of 100 patients randomised to rotating and fixed PE inlays in the Columbus knee~     prosthesis received a navigated TKR. Knee Society Score as primary endpoint, Oxford Score,~     and postoperative ROM after one year will be compared.~   "
209151|NCT00823329|"~     The investigators are developing two new medical instruments: 1. the Intelligent Sensor Belt~     (ISB), and 2. the Body Composition and Hydration Status Analyzer (BC-HS-A). ISB serves the~     purpose of measuring calorie/ energy consumption of the human body during physical activity.~     The BC-HS-A measures the body composition, i.e. the fat and lean body mass and the hydration~     status i.e the amount of water inside and outside of the body cells.~      The goal of this pilot study is to obtain data from the investigators prototype medical~     instruments: 1. ISB, and 2. BC-HS-A during physical exercise and compare those results with~     readings of other commercially available instruments or exercise equipments. The~     investigators would be testing for technical feasibility and, through comparison with~     existing measuring devices, the reliability of the investigators prototype.~   "
209152|NCT00823316|"~     The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human~     umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg~     in subject for the promotion of an engraftment and prevention of graft rejection and~     Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for~     children with acute leukemia.~   "
209153|NCT00823303|"~     Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to~     bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may~     have different effects on blood calcium. This study will randomize patients with SHPT and~     stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the~     incidence of high blood calcium, and effectiveness of SHPT treatment.~   "
209154|NCT00823290|"~     Histone deacetylase inhibitors (HDACi) like LBH589 have recently been established as novel~     potent anti-cancer agents for solid and hematologic malignancies. Several pre-clinical~     reports have shown a good anti-tumoral activity of different HDACi on human or murine HCC~     models. These compounds, e.g. Trichostatin A, SAHA, MS-275 and others, have been shown to~     induce apoptosis in HCC cells and to inhibit growth of HCC by inhibiting proliferation and~     tumor-related angiogenesis in vivo. Furthermore, HDACi sensitize HCC in a synergistic manner~     to other forms of cytotoxic stimulation, e.g. by conventional chemotherapeutic drugs or~     TRAIL-mediated apoptosis. It has also been shown that the combination of HDACi with various~     kinase inhibitors like sorafenib, erlotinib or others, promotes the anti-tumor efficacy of~     single agents.~      Based on the investigators' own previous experiences with different HDACi and LBH589 in~     preclinical HCC models, a strong anti-proliferative and pro-apoptotic as well as an~     anti-angiogenic effect will be expected by combining LBH589 with an existing sorafenib~     treatment. It is assumed that this combination will prolong overall survival and~     time-to-progression with lowered adverse effects in HCC patients.~   "
209155|NCT00823277|"~     Definition:~      the overall objective is to examine childhood obesity with focus on NAFLD and its treatment.~     Further, we aimed to investigate the impact of genetic variation on obesity.~      The specific aims are to;~        -  describe the degree of NAFLD among overweight and obese, Danish children. (hypothesis;~          the degree for pediatric NAFLD among Danish Children was equal that found in other~          Caucasian paediatric study populations).~        -  investigate the effect of a multidisciplinary intervention treatment of 1 year on liver~          fat content.~      (hypothesis; the intervention could reduce the liver fat percentage and a reduction in BMI~     SDS would associate with a reduction in liver fat content) - Analyze changes in liver fat~     content in relation to changes in levels of fasting blood variables to see if any of them~     could be used as a clinical tool for monitoring hepatic steatosis in the clinic.~      (hypothesis; serum aminotransferases (separately and their ratio, respectively), serum~     insulin, and HOMA-IR could predict improvement in liver fat content~      - Investigate the association between genetic variants and obesity.~   "
209156|NCT00823264|"~     Phenytoin is a medicine used to treat seizures. If too much is taken, patients have ill~     effects including sleepiness, unsteady gait, and eye problems. The amount of drug in their~     system can be measured in their blood. Charcoal is a medicine that can absorb phenytoin. We~     want to see if giving multiple doses of charcoal will quicken the removal of phenytoin from~     the blood. This is theorized to occur as charcoal absorbs phenytoin from across the~     intestines and then is secreted in the stool. Patients will be selected to receive either~     charcoal in multiple doses or no charcoal and their serum levels will be drawn repeatedly to~     follow their level. The different groups will then be compared to see if multidose charcoal~     does indeed increase the elimination of phenytoin from the body.~   "
209157|NCT00823251|"~     The purpose of this study is to assess the initial safety and technical feasibility of the~     IlluminOss System in the treatment of fractures of bones in the hand.~   "
209158|NCT00823238|"~     This is a prospective, randomized clinical trial comparing the effects of these 2 modes of~     antibiotic treatment on BALF inflammation in young, P. aeruginosa-positive CF patients.~   "
209159|NCT00823225|"~     The purpose of this study is to determine whether the additional therapy with low dose~     urokinase is more effective than only a conventional standard therapy concerning~     ulcer-healing, rate of major amputation and survival.~   "
209160|NCT00823212|"~     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™~     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo~     atherosclerotic coronary artery lesions.~      This clinical trial compares outcomes in patients treated with PROMUS Element to those in~     patients treated with a different everolimus-eluting coronary stent. The lesions are of~     average length in average-sized vessels (workhorse). A companion sub-trial evaluates~     outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions~     (LL).~   "
209161|NCT00823199|"~     This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10)~     poorly responsive patients with schizophrenia, monitoring their response and side-effects. No~     change in medication is required.~   "
209204|NCT00822627|"~     Randomized controlled trial of influenza vaccination versus referral for vaccination in the~     Emergency department. Is the Emergency Department an effective venue for vaccination for~     influenza? Does vaccination for influenza in the Emergency Department change the rates of~     influenza, influenza-like-illness or medical provider visits when compared with patient~     referred for vaccination in the community?~   "
209205|NCT00822614|"~     A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group Trial to Evaluate hte~     Safety of Fentanyl TAIFUN Treatment after titrated Dose Administration and the Current~     Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients on Maintenance Opioid~     Therapy~   "
209162|NCT00823186|"~     This phase I study is designed to establish an optimal dose of paclitaxel, under a fixed~     cisplatin dose at 40 mg/m2, delivered every week for three weeks, as neoadjuvant therapy~     before radical hysterectomy in bulky (FIGO IB2 or FIGO IIA with primary tumor dimension > 4~     cm) squamous cell cervical cancer. This study will be conducted at all branches of Chang Gung~     Memorial Hospital.~      The starting dose of paclitaxel is 50 mg/m2, and will be escalated by increments of 10 mg/m2~     to a maximum dose of 80 mg/m2. The drugs will be administered sequentially (paclitaxel first,~     followed by cisplatin) within one day every week for three cycles.~      A cohort of 3 patients, who are assessable for toxicity, is treated at each dose level. Each~     patient receives a fixed dose of paclitaxel and cisplatin, without modification. If none of~     the first 3 patients experiences a dose limiting toxicity (DLT, see definition below this~     paragraph), then escalation to the next dose level will proceed. If one patient develops a~     DLT, the cohort will be expanded to 6 patients. If no more than 1 of these 6 patients~     experiences a DLT, then escalation to the next dose level will proceed. The maximum tolerated~     dose (MTD) is the highest dose level at which no more than 1 of 6 patients experience a DLT.~     This dose level will be considered as the recommended dose for Phase II study. Although~     efficacy evaluation is not the main purpose of this study, a response rate of 60%, evaluated~     immediately before or at surgery, in all cases who have undergone 2 cycles of therapy is~     preset as a requirement for further phase II study using this regimen.The primary goal of NAC~     in cervical cancer is to improve the feasibility of surgical treatment, radical hysterectomy,~     without delaying the scheduled surgery or increasing the surgical risk or morbidity.~     Therefore, the definition of DLT for NAC is responded to this principle, in addition to the~     standard dose-limiting toxicity for phase I study.~   "
209163|NCT00823173|"~     The purpose of this study is to determine whether ESBA105, a topically applied TNF-alpha~     inhibitor, is safe and clinically active when applied to the eye of patients suffering from~     acute anterior uveitis~   "
209164|NCT00823160|"~     Penetrating wounds to the heart may present to the emergency unit with the presence of blood~     in the pericardial sac as determined on ultrasound. If these patients are stable, the study~     hypothesis is that they can be managed with a very simple surgical procedure called a~     subxyphoid pericardial window (SXW), in which the blood is drained from around the heart via~     a small skin incision below the rib cage. In all other centres in the world these cases are~     managed by open chest surgery called a sternotomy. The investigator's experience in dealing~     with these injuries is that this is unnecessary and requires a large amount of resources for~     no benefit to the patient.~      In this study, patients are randomized to receive either open chest surgery (sternotomy) or~     the much smaller operation of the SXW. The patients are then followed up with respect to~     their hospital stay and any complications that they develop. Normally, a patient undergoing~     open chest surgery will stay in intensive care unit for a minimum of 2 days and have a total~     hospital stay of at least 7 days and be at risk of a number of complications such as~     pneumonia. Patients undergoing a SXW usually remain in hospital for a period of 3 days and do~     not require intensive care management.~      The investigator's hypothesis is that in all these patients the heart injury has sealed and~     the patient is no longer in any danger. It is not necessary to perform open chest surgery on~     these patients.~   "
209165|NCT00823147|"~     Research shows that the immune system is involved in chronic pain. The immune system is~     involved in the process of inflammation. The investigators are still learning about the~     factors that cause inflammation, but know it can be measured in the blood. The purpose of~     this study is to understand how negative thoughts affect the immune system in women with~     chronic pain.~      A sub-study asks subjects to store a blood sample for future research by the PI aimed at~     identifying genetic markers in women with chronic pain.~   "
209166|NCT00823134|"~     The purpose of this study is to investigate the following topics:~        -  Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas,~          Mixed Apneas and Central Apneas.~        -  Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008~          guidelines of the AASM = American Academy of Sleep Medcine.~        -  Determine whether patients can start and stop the recorder and are able to attach the~          additional effort sensor by themselves using the patient instruction sheet~   "
209167|NCT00823121|"~     Cryopreservation of all embryos and transferring them subsequently in assisted reproductive~     technology (ART) cycles to improve outcome.~   "
209168|NCT00823108|"~     The purpose of this study is to determine if a glucose-insulin-potassium (GIK) solution can~     be safely administered to patients with septic shock. GIK has been used in thousands of~     critically ill patients in research studies with very few safety concerns. However, there is~     a lack of data in regards to patients with septic shock. There are many reasons to believe~     that GIK would be beneficial in sepsis, including improving heart function and decreasing~     inflammation. This study will administer intravenous GIK for 12 hours continuously and~     monitor 10 subjects for 24 hours. A control arm will be used and 10 patients will receive the~     same monitoring but will not receive GIK.~   "
209169|NCT00823095|"~     To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the~     reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by~     measurements of wound size and wound culture.~   "
209170|NCT00823082|"~     The purpose of this trial is to study the effects of preoperative antithrombin~     supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order~     to maintain antithrombin levels in a range greater than 58% of functional activity and,~     eventually, to decrease negative clinical outcomes during the ICU stay.~   "
209171|NCT00823069|"~     Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the~     area around your nose.~   "
209172|NCT00823056|"~     Probiotics has been known as a dietary supplement for a long period. Recent clinical trials~     indicate that probiotics might have an effect in preventing common infection diseases in~     children.~      The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a~     daily intake of a suspension containing probiotics in a period of 9 months, the incidence of~     diarrhoea and respiratory diseases can be reduced.~   "
209173|NCT00823043|"~     The objective of the study was to evaluate whether timolol hemihydrate is more comfortable~     upon instillation than timolol maleate in sorbate. This was an observational study. Subjects~     with open-angle glaucoma or ocular hypertension were asked to complete a survey regarding~     their normal treatment. No treatment was prescribed.~   "
209234|NCT00822237|"~     This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured~     with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly~     administered with M-M-R II in healthy children.~   "
209235|NCT00822224|"~     Acute pain is frequent in elderly especially in geriatrics acute care units where painful~     procedures are often occurring.~      MEOPA represents an alternative to opioïd therapy to prevent procedural pain during the~     treatment of pressure ulcers.~      In this study, cognitive impairment and dementia do not limit the use of MEOPA. The new~     approach in the management of acute procedural pain provides effective and safe analgesia in~     frail old patients.~   "
209174|NCT00823030|"~     The purpose of this study is to determine the amount of improvement in bladder function and~     pain relief with the administration of 2% alkalinized lidocaine in patients with interstitial~     cystitis. Specifically, we want to see if the administration of 2% alkalinized lidocaine~     treatments in the bladder improves urodynamic test result values. We hope to enroll~     approximately 40 patients in this study.~      Previous research has shown that the administration of 2% alkalinized lidocaine in the~     bladder may improve the bladder's capacity to hold urine and urine flow rates while~     simultaneously providing pain relief. As part of standard of care at the Smith Institute of~     Urology Pelvic Pain Center, we routinely offer our IC patients 2% alkalinized lidocaine with~     follow up urodynamic evaluation. Our research looks to expand upon the prior studies and~     confirm the findings of improved bladder function and enhanced pain control of 2% alkalinized~     lidocaine versus placebo by performing a second urodynamic evaluation, which is not routinely~     performed.~   "
209175|NCT00823017|"~     The purpose of this study is to investigate the effects of patient-preferred music,~     relaxation music, and standard care environment on patients in intensive care units.~   "
209176|NCT00823004|"~     Failure to respond to controlled ovarian hyperstimulation (COH) is still a major concern in~     assisted reproduction and there is no consensus on the ovarian stimulation choice regime for~     poor responders.~      Aim: To evaluate and compare the efficacy of a microdose GnRH agonist flare (MF) and a GnRH~     antagonist/letrozole (A/L) protocols in poor responders undergoing in vitro fertilization~     (IVF).~      Methods: One hundred eighty poor responder patients will be randomized to an ovarian~     stimulation protocol with either a MF or a letrozole and high dose FSH/hMG and flexible GnRH~     antagonist protocol.~   "
209177|NCT00822991|"~     The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using~     Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound~     (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk~     patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by~     CE-US has a survival benefit than that by B-mode US.~   "
209178|NCT00822978|"~     This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people.~     Groups of people will receive either the study medication (ACHN-490) or a placebo (normal~     saline) as a single infusion. If the single dose is well tolerated then this group will~     receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the~     study medication at a higher dose than the previous dose level as long as the previous dose~     was safe.~   "
209179|NCT00822965|"~     The specific aims of the patient intervention are to:~        1. increase patient knowledge about pacemakers (PM) and implantable~          cardioverter-defibrillators (ICDs)~        2. help patients to identify if their PM or ICD has been interrogated~        3. improve patient's physician-patient communication skills~        4. teach patients how to identify if their device has been recalled~        5. train patients what to do in case of a device recall~      The educational interventions proposed, if proven to be effective by this pilot, will provide~     a low-cost, reproducible intervention to improve the clinical care and safe management of~     pacemakers (PM) and implantable cardioverter-defibrillators (ICD) in patients. The goal of~     the intervention will be to promote the safe use of implantable pulse generators.~   "
209180|NCT00822952|"~     The purpose of this study is to evaluate an imaging capability Prostate Mechanical Imager~     (PMI), a PC-based device utilizing a transrectal probe with pressure sensor arrays and motion~     tracking system, aimed at providing composite elasticity images of the prostate.~   "
209181|NCT00822926|"~     Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has~     also been reported to be helpful for some pain conditions. The investigators have observed~     prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin~     Type A (BTA) in patients with certain types of neuropathic pain. the investigators propose to~     study if addition of BTA extends pain relief compared to placebo when injected subcutaneously~     into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is~     perceived as painful).~   "
209182|NCT00822913|"~     The researchers investigated the effectiveness and safety of BoNT/A injected into the~     detrusor muscle in patients with PD and MSA all of whom had detrusor muscle overactivity~     unresponsive to conventional medical therapy.~   "
209183|NCT00822900|"~     The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of~     injury and given for a total of 96 hours), is more effective than placebo for treating~     victims of moderate to severe acute traumatic brain injury.~   "
209184|NCT00822887|"~     The purpose of the study is to find out the highest dose of vandetanib that can be safely~     given with repeat radiation therapy.~      This study drug has been designed to block certain chemical pathways that stimulate tumor to~     grow. The study drug has been shown to slow the growth of a number of types of cancers.~      This will be a dose escalation study. A dose escalation study means that successive groups of~     patients will receive higher doses of the study drug. There are three dose levels. The dose~     of the study drug received will depend on the stage the study has reached at the time a~     patient decides to participate.~      In addition to taking the study drug patients will also receive radiation therapy to the~     brain tumor for 3 days.~      Hypothesis The objective of this study is to determine the maximally tolerated dose (MTD) of~     VANDETANIB given with 36 Gy hypofractionated stereotactic radiotherapy. The MTD will be dose~     of VANDETANIB at which no patients develop acute grade 5 toxicity and less than 30% of~     patients develop acute (within 30 days of radiation therapy) or delayed (at least 30 days~     after radiation completed) dose limiting toxicities.~   "
209185|NCT00822874|"~     A single centre randomised controlled trial investigating the influence of a novel~     prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of~     oocytes - pilot study.~   "
209186|NCT00822861|"~     During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic~     anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum~     eosinophils and the airway responses during an allergen challenge at different dose levels.~   "
209236|NCT00822211|"~     The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid~     compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM~     inadequately controlled by metformin alone.~   "
209237|NCT00822198|"~     The purpose of this study is to assess the effect of vibration of the plantar surface of the~     foot on peripheral neuropathy.~   "
209187|NCT00822848|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as epirubicin and ifosfamide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. Giving these treatments after surgery may kill any tumor cells that remain after~     surgery.~      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when~     given together with epirubicin, ifosfamide, and radiation therapy followed by surgery in~     treating patients with high-risk stage II or stage III soft tissue sarcoma.~   "
209188|NCT00822835|"~     The purpose of this study is to evaluate the safety and tolerability of single doses of~     ILV-095 in healthy subjects.~   "
209189|NCT00822822|"~     The purpose of this research study is to find out what Moffitt and Lifetime patients think of~     the electronic medical records process.~   "
209190|NCT00822809|"~     This is a randomized phase IIIb study investigating the treatment of malignant ascites due to~     epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make~     the catumaxomab treatment more convenient for the patient and the hospital praxis the~     tolerability of 3 hour infusions of catumaxomab with and without premedication of~     prednisolone is evaluated.~      A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to~     two treatment groups in a 1:1 ratio.~   "
209191|NCT00822796|"~     The purpose of this study is to determine if the Thermogard™ central venous catheter can~     prevent hypothermia (defined as a core body temperature less then 36.0 °C) in severely burned~     patients who are undergoing surgery for debridement and grafting in the setting of reduced~     ambient room temperature.~   "
209192|NCT00822783|"~     Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic~     dermatitis; in fact, many patients with atopic dermatitis have high IgE levels. This study~     tried to explore whether the depletion of IgE from blood and skin might result in a change of~     immunological parameters and might alter the clinical course of the disease.~   "
209193|NCT00822770|"~     The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor)~     and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood~     stem cell transplant. This treatment will be studied in patients with acute myeloblastic~     leukemia (AML), myelodysplastic syndromes (MDS), or Chronic myelogenous leukemia (CML).~   "
209194|NCT00822757|"~     This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of~     Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to~     provide necessary safety and immunogenicity data for the lyophilized formulation of V710~     prior to its subsequent evaluation in patients at risk for developing serious S. aureus~     infections.~   "
209195|NCT00822744|"~     The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298~     (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive~     Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale.~      Secondary objectives are:~        -  To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus~          placebo in elderly patients with MDD.~        -  To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep,~          pain and somatic symptoms related to depression, and bone markers.~        -  To assess SSR411298 plasma concentrations.~        -  To assess plasma endocannabinoid concentrations.~   "
209196|NCT00822731|"~     The purpose of this study is to establish a model which can predict the treatment outcome and~     the risk of treatment-related morbidity in patients with lymphoma.~   "
209197|NCT00822718|"~     According to Seoul cancer registry data (2000), cancer became the leading cause of death in~     Korea, accounting for 23.9% of all deaths and gastric cancer is the most prevalent malignant~     neoplasm, comprising 20.8% of all cancers. Korea and some part of Asian countries have the~     highest incidence of gastric cancer in the world. Therefore, gastrectomy became one of the~     most common cancer operation in Korea. Thanks to early detection and intervention, the~     mortality of early gastric cancer drops dramatically and is now believed to be one of the~     most curable diseases among all the cancers. However, after successful operation and the~     declaration of cure of the stomach cancer, the patients are left without stomach for all his~     remaining life. If the patients lose most of his stomach tissue, there are several problems,~     which include loss of reservoir function for food and indigestion. Besides, loss of appetite~     is of the paramount importance because the stomach is an important endocrine organ~     controlling the appetite via gut-brain axis and the main axis is through a hormone called~     ghrelin, the only orexigenic hormone in human.~      Because ghrelin is mainly secreted by the fundus and body, operations such as laryngoscopic~     Roux-en-Y gastric bypass: (LRYGBP), laryngoscopic-adjustable silicone gastric banding (LASGB)~     virtually abolish the ghrelin expressing cells. Thus loss of appetite is an inevitable~     consequence. Then what happens of the plasma ghrelin after Billoth surgery (standard gastric~     cancer operation) which removes antrum and body of the stomach where ghrelin expressing cells~     are relatively less distributed? Also puzzling is the fact that after surgery some patients~     start to gain weight while others continue to lose weight and appetite. Are there~     ghrelin-expressing cell hyperplasia in the patients who start to gain weight?~      The gastrectomy operation which is performed at the investigators institute is Billoth I or~     II operation. The operation virtually eliminate the half of the body and most of the antrum.~     If fundus is involved also, proximal gastrectomy is the operation of the choice. Most of the~     patients who have these operations will lose weight during 1-3 months after surgery,~     thereafter slowly recover. However, the mechanism of the weight recovery has not been~     elucidated so far.~      To elucidate the mechanism of re-gaining body weight and possible ghrelin expressing cell~     hyperplasia, the investigators designed the prospective study to investigate the stomach~     tissue as well as plasma ghrelin in the patients who are going to have Billoth surgery. The~     items to be investigated include plasma for hormones (ghrelin, leptin, insulin, CCK, PYY),~     stomach tissue for ghrelin, diet evaluation and body weight (body mass index) changes for 7~     months after gastrectomy.~      The investigators hope that their study will reveal the valuable information on the body~     weight recovery and appetite issue. So far the issue of the stomach cancer patients was~     related to survival issue. However, to lead a comfortable life the quality of life is also~     very important. The investigators approach will hint the way of surgery which will benefit~     the patients to live a happy life.~   "
209198|NCT00822705|"~     Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects~   "
209199|NCT00822692|"~     Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke~     Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated~     skin abscess.~   "
209200|NCT00822679|"~     The purpose of the study is to examine the effects of Eszopiclone, a sleep aid, on~     inflammatory mediators and coagulability in patients with a recent myocardial infarction.~   "
209201|NCT00822666|"~     To evaluate the role of the genetic variant 2C19*2 on the pharmacodynamic response as~     assessed by optical aggregometry and on the pharmacokinetic response as assessed by measuring~     active metabolites following an oral administration of a loading dose of 300/900mg of~     clopidogrel in patients with established coronary artery disease.~   "
209316|NCT00821132|"~     We are collecting blood samples, clinical and family information from ALS (amyotrophic~     lateral sclerosis) patients and their families to identify causes of ALS and ALS/dementia.~   "
209206|NCT00822601|"~     Our study's purpose is to show the efficacy of the transcranial magnetic stimulation (a non~     invasive method of cerebral modulation) in patients suffering from chronic obsessive~     compulsive disorder (OCD). This new method will be applied in 20 patients during 4 weeks (5~     sessions each week), and its effects on OCD symptoms will be compared to those of a sham~     (=placebo) stimulation applied with the same process in 20 other patients, randomly assigned~     to the comparison group. The maintenance of the therapeutic effects will be explored during 8~     weeks following the end of the treatment. In addition to classical scales used to measure the~     treatment effects, all patients will be examined using a functional magnetic resonance~     imaging (fMRI) before and after treatment to explore the cerebral effects of rTMS~   "
209207|NCT00822588|"~     The study is a prospective, controlled, randomised and assessor blind study that investigate~     if the need for bank blood transfusion could be reduced in patients, undergoing primary or~     revision total hip replacement surgery, who receive their own blood back with the medical~     device Sangvia.~      A comparison in need for bank blood will be made between patients that either receive their~     own blood back or not.~   "
209208|NCT00822575|"~     The purpose of this study is to determine whether over-the-counter (OTC) use of the~     ZapperClick device employing the piezo-electricity principle is effective in reducing itching~     associated with mosquito bites.~   "
209209|NCT00822562|"~     In this study, we intend to divide the subjects who have been confirmed recurrent HCC into~     two groups: Group A: treatment with pure surgery or Group B: treatment with pure radio~     frequency. We will compare the non-tumor survival time, long-term survival rate between the~     two groups, summarize the merits and demerits of both groups, and try to establish a~     standardized therapy and treatment for the this kind of patients through prospective studies~     on the molecular biological difference of pathological samples between the first and second~     surgeries.~   "
209210|NCT00822549|"~     The main objective of this study is to improve our knowledge on the pharmacodynamic,~     pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe~     postoperative pain. The analysis will encompass the efficacy (acute during titration and~     subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to~     better characterize the age- and sex-related differences which probably markedly differ~     between the two periods (acute vs sub acute).~   "
209211|NCT00822536|"~     To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin~     and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting~     stent (DES) implantation.~   "
209212|NCT00822523|"~     The purpose of this feasibility study is to determine if temporary weakness of a small foot~     muscle caused by local injection of botulinum toxin into that muscle can be measured with a~     strain gauge in addition to the previously known valid measurements via nerve conduction~     studies and surface electromyogram.~   "
209213|NCT00822510|"~     The purpose of this project is to test a telephone delivered educational support program~     versus an education only program for improving symptom management and quality of life in men~     with prostate cancer and their partners.~   "
209214|NCT00822497|"~     The purpose of this prospective, crossover randomized study is to explore the efficacy of two~     music therapy protocols on pain, anxiety, and muscle tension levels throughout the~     debridement process in individuals hospitalized with moderate to severe burns.~   "
209215|NCT00822484|"~     The purpose of this study is to evaluate the safety and tolerability of single doses of~     ILV-095 in healthy Japanese male subjects.~   "
209216|NCT00822471|"~     A concise diabetes self-management education (DSME) program on the ABCs of Diabetes will be~     placed in an urban public library to assess the feasibility of using this community setting~     for the delivery of health care education in an urban African American population. Impact on~     knowledge of, prescriptions for, and control of blood sugar (A1C), blood pressure (BP) and~     LDL cholesterol (LDL-C)before and after participation in the program will be assessed. We~     will also examine the frequency of emergency department (ED) visits and hospitalizations for~     uncontrolled diabetes at 6 months post-DSME intervention.~   "
209217|NCT00822458|"~     This phase I trial is studying the side effects and best dose of GDC-0449 in treating young~     patients with medulloblastoma that is recurrent or did not respond to previous treatment.~     GDC-0449 may be effective in treating young patients with medulloblastoma.~   "
209218|NCT00822445|"~     Traumatic brain injury (TBI) is a Public Health problem, because of the numbers of events~     (more than 200,000 per year in France). Craniocerebral tomodensitometry (CCT) is widely used~     for the diagnosis of minor/mild TBI, but both the access to the CCT and the cost of this~     imagery are critical factors. We hypothesized that the blood level measurement of S100~     protein (S100), a neurological biomarker of cerebral injury, would help to the clinical~     evaluation of minor/mild head injury events, and would be an economic alternative to CCT for~     the diagnosis of these pathologies. In addition, a part of the study will explore the~     prognostic value of such blood level S100 determination for the evaluation of medical/social~     consequences of minor/mild TBI.~      Medical objective of the study:~        1. to assess the contribution of early determination (to medical care) of S100 for the~          diagnosis of minor/moderate TBI (TCCMM - Glasgow sup or equal to 9),~        2. to determine the usefulness of a second dosage three hours later for the medical~          decision.~      In other words, to compare S100 biomarker and CCT considered as a reference ( Gold~     Standard) for the diagnosis or exclusion of TCCMM, and to precise its terms of use.~      Economic objective:~      to conduct a cost-effectiveness study of blood level determination of S100 vs. CCT for the~     diagnosis of minor/moderate TBI and its medical/social consequences~   "
209219|NCT00822432|"~     High dose methotrexate (MTX) is responsible of severe toxicity in patients in whom~     elimination from plasma is delayed. Factors responsible for MTX accumulation are partly known~     but some patients still experience toxicity despite adequate measures being taken. Our~     hypothesis is that renal tubular secretion may be impaired in these patients. This study aims~     at evaluating the performance of the UCP ratio (urinary ratio of coproporphyrins), a putative~     biomarker of tubular secretion, in predicting delayed MTX elimination.~   "
209220|NCT00822419|"~     Since midsternotomy is painful postoepratively, and since ketamine has been shown to be~     optimal postoeprative analgessic adjuvant, the investigators wish to assess its percutaneous~     preemptive effect, comparing it to lidocaine effect.~   "
209221|NCT00822406|"~     A total of 41 adults with perennial allergic rhinitis were enrolled in a first double-blind~     placebo-controlled phase for six months, and treated on a weekly basis with sublingual doses~     of single individualized homeopathic medicines or placebo. After this closed initial phase,~     all patients were invited to participate in an long-term open-label controlled phase, in that~     they would receive homeopathic treatment for the maximum period of 36 months, and the results~     were compared with the improvement of initial phase. Signs and symptoms scores, rescue~     medication requirements and quality of life were assessed by questionnaires and personal~     clinical evaluation by a same independent researcher, before and after each phase. Primary~     and secondary clinical outcome were, respectively, specific and general allergic signs and~     symptoms scores. Total IgE titles were performed before and after each phase.~   "
209222|NCT00822393|"~     This randomized allogeneic transplantation protocol compares i.v. Treosulfan-based~     conditioning therapy with reduced intensity i.v. Busulfan-based conditioning in adult AML and~     MDS patients at increased risk for standard conditioning therapies. The protocol is based on~     results of previous phase I/II trials evaluating Treosulfan/Fludarabine conditioning prior to~     allogeneic haematopoietic stem cell transplantation. The reference arm (reduced intensity~     i.v. Busulfan/Fludarabine) is considered to be accepted medical practice for the study~     patient population.~   "
209223|NCT00822380|"~     Anemia continues to be a major public health problem in many regions of the world and it is~     still not clear which strategy is more effective in children population in terms of adherence~     and efficacy. The objective was to evaluate the efficacy and acceptance of several strategies~     that have been recently recommended to treat anemia on anemic children (6 to 43 mo):Iron~     supplement, iron+folic acid supplement, a multiple micronutrients supplement a micronutrient~     fortified complementary food in the form of porridge powder or zinc+iron+ascorbic acid~     fortified water.~   "
209224|NCT00822367|"~     The purpose of the study is to determine which of the commonly used meal supplements is the~     best product for patients with DM. This is important because meal supplements are becoming~     more popular as meal replacements in the United States. Peak blood sugar occurs about 2 hours~     later after a meal. Therefore, the best product would be the one that produces a smallest~     rise in blood sugar.~   "
209225|NCT00822354|"~     The investigators propose that tadalafil will increase digital blood flow and improve the~     symptoms and signs of secondary Raynaud's phenomenon.~   "
209226|NCT00822341|"~     TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model,~     this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy~     subjects.~   "
209227|NCT00822328|"~     Fermented milk is a popular drink. Recent studies revealed that some fermented milk~     containing some strains of lactic acid bacteria have health-promoting effects through~     improvement of the intestinal microflora and modulation of the immune system. Lactobacillus~     casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk~     products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced~     immune responses in allergic rhinitis, altering fermentation patterns in the small bowel,~     prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk~     containing at least 3x10^10 live LcS cells per 100 ml bottle. This study aimed to evaluate~     the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the~     human intestinal microflora.~   "
209228|NCT00822315|"~     Raltegravir is a potent antiretroviral agent that could be used as an alternative to~     efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic~     interactions, the optimal dose of raltegravir to be used in combination with rifampin is~     currently unknown.~      This phase II open-label randomized multicenter trial is designed to estimate the antiviral~     efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in HIV-1 naive~     patients co-infected with active tuberculosis (TB) treated with rifampin.~   "
209229|NCT00822302|"~     The plasma concentration of high-density lipoprotein (HDL) can have anti-inflammatory,~     anti-oxidative and anti-thrombotic effects in addition to being able to remove cholesterol~     from peripheral tissues for secretion via the liver.~      The investigators hypothesise that elevation of plasma HDLs will reduce the inflammatory~     response following removal of unstable atherosclerotic plaques in the carotid artery. Such~     plaques can cause strokes and there is great benefit from early surgical removal, however~     such surgical procedures involve significant risks to the patient.~      The investigators propose infusing HDL into patients prior to removal of their unstable~     carotid plaque and measuring the changes in inflammatory responses in comparison to a similar~     placebo controlled group of patients.~   "
209230|NCT00822289|"~     Because of the high iodine uptake in the stomach, radioactive iodine treatment for thyroid~     diseases (cancer or hyperthyroidism) or radioactive iodine administered for thyroid scan may~     be able to eradicate H.pylori infection from the stomach of patients infected with H.pylori.~      Also to test the hypothesis that CagA virulent strains of H.pylori are more common in~     patients with thyroid cancer than with other thyroid diseases.~   "
209231|NCT00822276|"~     Staphylococcus aureus (S.aureus) is a bacterium that causes many painful skin and soft tissue~     conditions, such as scalded-skin syndrome, boils, or impetigo. Serious cases may result in~     deadly complications but S.aureus can usually be treated successfully with antibiotics. There~     are, however, certain strains which cannot be treated with standard antibiotics.~     Methicillin-resistant staphylococcus aureus (MRSA) is one such strain.~      MRSA is increasingly being seen in both hospital and community settings, making it a serious~     public health issue. People with Atopic Dermatitis (AD), particularly those with a history of~     Eczema Herpeticum (EH), may be at greater risk for infection by MRSA. The reason for this~     higher risk is unknown but may be linked to extended treatment with staphylococcus~     antibiotics in addition to the absence of certain proteins on their skin, which have immune~     function. The purpose of this study is to determine the reasons for MRSA infection in AD~     participants with and without a history of EH.~   "
209232|NCT00822263|"~     The administration of N-acetyl-cysteine (an anti-oxidant) for seven days along with~     observation will result in improved hearing and balance function in individuals who~     demonstrate these disorders after blast exposure when compared to a placebo medicine and~     observation at the seven day time point.~   "
209233|NCT00822250|"~     The purpose of this study is to determine the molecular mechanism of this disease and to~     research the relationship between cystinosis and skin phenotype.~   "
209239|NCT00822172|"~     The purpose of this study is to see how safe and effective L carnitine taken with cilostazol~     is compared to placebo taken with cilostazol for people with intermittent claudication. A~     second purpose of the study is to see if L-carnitine is absorbed into the blood stream.~   "
209240|NCT00822159|"~     Hip fractures mostly occur in elderly people with low bone strength. Bone strength is~     determined by bone mineral density (BMD), bone turnover, microarchitectural and geometrical~     properties of the bone. Dual energy x-ray absorptiometry (DXA) is the standard technique to~     measure BMD. However, BMD just provides information regarding the quantity of mineral in~     bone, which is only one component of bone strength. To date there is no reliable method to~     assess bone strength in vivo. Therefore, a method to assess bone strength beyond BMD would~     provide additional information regarding the patients' risk of bone related fixation failure~     after fracture fixation.~      DensiProbe is a new diagnostic device that was developed for intra-operative assessment of~     mechanical stability of the bone in the proximal femur. It consists of a drill bit like tool~     and an electronic system to measure the peak torque to break-away of trabecular bone in the~     femoral head of patients undergoing DHS surgical treatment. In a cadaver study comparing bone~     mineral density measured by quantitative computed tomography with bone strength measured by~     DensiProbe a high correlation between these two parameters could be shown. In a clinical~     pilot study a significant correlation between DensiProbe measurements and BMD measured by DXA~     at the femoral neck in patients with hip fractures could be shown. However, no perfect~     correlation was expected because DensiProbe measures bone strength, which is only partly~     caused by BMD.~      Bone related fixation failure, such as secondary loss of reduction, is influenced by bone~     strength, bone mineral density, fracture type, fracture reduction and primary positioning of~     the implant. The predictive value of DensiProbe measurements for secondary loss of reduction~     needs to be investigated. If DensiProbe turned out to be an effective screening tool for~     patients with low bone strength that are on higher risk of the aforementioned complications~     these patients may in future benefit from alternative treatment methods (e.g. augmentation~     techniques) in order to reduce bone related fixation failure.~      The primary aim of the present study is to investigate if bone strength measured by~     DensiProbeTM Hip (DensiProbe) is an independent factor to predict secondary loss of reduction~     (screw migration of 5 mm or more and / or telescoping of 10 mm or more) in patients with hip~     fractures after fracture fixation with DHS.~   "
209241|NCT00822146|"~     The aim of this research study is the invasive evaluation of CR therapy efficacy in patients~     treated with an InSync Sentry device using an external monitoring device to obtain important~     cardiac parameters.~   "
209242|NCT00822133|"~     Since VAT bears with it severe postopearive pain, and since ketamine has been shown to be an~     optimal analgesics adjuvant for postoperative pain, we wish to assess to effects of ketamie~     vs. lidocaine if put on the skin in the sites where scopes are interset into the chest for~     thoracoscopy.~   "
209243|NCT00822120|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side~     effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F~     18-PET/CT imaging, may help doctors predict how patients will respond to treatment.~      PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well~     it works in assessing response to combination chemotherapy and allow doctors to plan better~     additional further treatment in treating patients with stage III or stage IV Hodgkin~     lymphoma.~   "
209244|NCT00822107|"~     The purpose of this study is to test the hypothesis that Gitelman syndrome (GS) can be~     diagnosed using a simple clinical protocol. GS is an inherited kidney disease that usually~     shows up in patients as low blood potassium levels. Currently, no commercial genetic test for~     GS exists. Currently, GS is diagnosed based upon clinical findings but this method is not~     precise and often not reliable. Thus, in order to develop new treatments specific for GS~     patients, a more exact method of diagnosis would be of benefit.~      Eligible subjects are men and women ages 21-60 with normal blood pressure who have been~     diagnosed with low blood potassium of uncertain cause. Subjects may withdraw at any time.~      This study requires 3 visits to OHSU's campus. Study Visit 1 will occur during a normal visit~     with the nephrologist. As part of the normal visit, a complete interview, physical exam and~     urine and blood samples will be taken. In addition, another blood sample will be taken and~     used for genetic analysis. A urine pregnancy test will be administered. A Quality of Life~     survey, described below, will be administered. The genetic analysis, urine pregnancy test and~     Quality of Life survey are not normal tests for GS. Blood and urine samples, as well as~     pregnancy tests will be collected/administered at the Oregon Clinical and Translational~     Research Institute (OCTRI).~      During the intervention period, subjects will refrain from taking their potassium sparing~     medications for 7 days. This period is called the washout period and is needed to ensure that~     blood tests during the hydrochlorthiazide (HCTZ, a water pill) (see below), are not~     affected by medications. On the 3rd day of the washout period, Study Visit 2 will occur at~     the OCTRI. This will require blood to be drawn, to insure that subjects maintain proper blood~     levels of potassium and magnesium. Magnesium and potassium supplements will be allowed during~     the washout. After review of the blood test results, the investigator may adjust the doses of~     these supplements in order to keep subject blood levels of potassium and magnesium as close~     to normal as possible. Blood pressure, heart rate and breathing rate will also be checked at~     this visit.~      Study Visit 3 will occur at the OCTRI and will be devoted to the HCTZ test. During the course~     of the HCTZ test, subjects will have an plastic tube (an IV) placed in an arm vein, have~     vital signs checked and receive 50mg of HCTZ to take by mouth . Subjects will provide 8 urine~     samples and 3 blood samples. The time required for this visit is expected to be 6 hours.~      The total time required for subjects to complete the study from Study Visit 1 through~     discharge from the OCTRI on Study Visit 3 will not be less than 9 days and subjects should~     not expect the total length to exceed three weeks depending on available appointments for~     Study Visit 3 at the OCTRI.~      The Quality of Life survey is derived from a national research corporation and has been~     modified for use in this study. The authors of this survey allow free public use of this~     document provided it is properly referenced in any presentation of the study's results.~      HCTZ is an FDA approved medication. There are no experimental drugs or devices used in this~     study.~      The purpose of this study is to develop methods for, and determine the feasibility of,~     performing a HCTZ test and genetic analysis for GS at OHSU. There is no statistical analysis~     of data, but descriptive characteristics will be entered into an Access database with~     password restricted access. Genetic samples will be analyzed using PCR and standard~     sequencing techniques. Data and samples will be stored for a maximum of 15 years.~   "
209245|NCT00822094|"~     The study investigates if CPX-351 will be a) more effective than the standard intensive~     salvage AML treatment and b) more tolerable than the standard intensive salvage treatment~     regimens.~      The study compares the investigational product CPX-351 vs the standard intensive salvage~     treatment for first relapse AML patients.~   "
209246|NCT00822081|"~     This study compares the efficacy and tolerability/comfort of brimonidine/timolol and~     dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an~     investigator masked randomization process, each subject is allocated to recieve either~     brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an~     adjuctive to a prostoglandin analogue for a period of 12 weeks. After screening, patient~     returns at baseline, Month 1, and Month 3 for ophthalmic evaluations.~   "
209247|NCT00822068|"~     The study aims to identify if intensive language training, consisting mainly of~     computer-based object naming, together with electrical brain stimulation, will lead to an~     improvement of language functions in patients that suffer from language disturbances after a~     stroke.~   "
209248|NCT00822055|"~     This study compares the efficacy and tolerability/comfort of brimonidine/timolol and~     dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an~     investigator masked randomisation process, each subject is allocated to received either~     brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an~     adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient~     returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.~   "
209249|NCT00822042|"~     Hypothesis: systemic therapy with corticosteroid induces morphological changes (e.g., moon~     face, buffalo neck) called lipodystrophy (LD). We hypothesize that this LD is associated with~     variation of adipocytokines (e.g., adiponectin, leptine, IL6) levels~      Primary objective: To show a 50% decrease in adipocytes adiponectin's expression in patients~     who developed LD versus those who did not developed LD during the first 3 months of a~     systemic therapy with corticosteroids~      Secondary objectives: To look for differences in the mRNA expression of 11bHSD1, SREBP1c and~     PPARg in fat samples of patients before and after treatment with systemic corticosteroids and~     between LD+ and LD-patients To compare the fat morphology before and after treatment with~     glucosteroids~   "
209250|NCT00822029|"~     It is a double blind randomized study aiming at estimating the efficiency of oral~     bisphosphonates on the decrease of osteoporosis by comparing the evolution of densitometric~     values between two groups of children (treatment versus placebo).~   "
209251|NCT00822016|"~     The purpose of this study is to establish a listing (database) of patients diagnosed with~     lung cancer and treated with best supportive care and standard and investigational~     chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites.~     The information will be used to determine the results of various treatments for lung cancer~     subjects and to find where improvements can be made in safety, effectiveness, supportive~     care, treatment that eases tumors without curing them, treatments that cure tumors,~     prevention, and follow-up efforts. The database information will be compared to clinical~     trial data published in peer-reviewed journals and SEER outcome data. Patients will be~     acquired both before and after they are treated for lung cancer.~   "
209252|NCT00822003|"~     The investigators aimed to investigate the pharmacokinetic and pharmacodynamic effects of a~     single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT)~     in 16 healthy males~   "
209344|NCT00820781|"~     In unselected cirrhotic patients with bleeding gastric varices to compare the influence on~     mortality rate, duration of life, control of bleeding, quality of life, and economic costs of~     treatment of: portacaval shunt, endoscopic variceal sclerotherapy and/or variceal ligation.~   "
209253|NCT00821990|"~     Because well-designed, randomized, controlled clinical trials are lacking in patients with~     advanced gastric cancer (AGC), and because randomly allocating patients to treatments that do~     not accord with their preferences may influence trial validity, the investigators employed a~     patient preference randomized trial design to compare the efficacy of second-line~     chemotherapy and best supportive care.~   "
209254|NCT00821977|"~     This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes~     patients receiving vildagliptin as monotherapy.~   "
209255|NCT00821964|"~     This phase II trial is studying the side effects of giving topical imiquimod together with~     Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) to see how well it works in~     treating patients with advanced breast cancer. Biological therapies, such as imiquimod, may~     stimulate the immune system to kill tumor cells. Drugs used in chemotherapy, such as~     Abraxane, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving imiquimod together with Abraxane may kill~     more tumor cells.~   "
209256|NCT00821951|"~     This is a dose escalation study that will assess the safety of Vorinostat, a Histone~     Deacetylase (HDAC) inhibitor, in combination with palliative radiotherapy in patients with~     advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Vorinostat has been approved for~     use in patients with cutaneous T-cell lymphomas, but several pre-clinical studies suggest~     activity in lung cancer cell lines. Several HDAC inhibitors,including Vorinostat, may enhance~     the effect of radiotherapy, and this study will seek to confirm this.~   "
209257|NCT00821938|"~     Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients~     with narrow QRS complex and optimized medical treatment but echocardiographic~     desynchronization detection as well as the positve increase of the intraoperative~     pressureincreasespeed in reverse remodelling and a secondary improvement of functional~     parameters~   "
209258|NCT00821925|"~     The purpose of this study is to estimate Osteoporosis' prevalence in France and is a pilot~     study in the Department of the Alpes-Maritimes.~   "
209259|NCT00821912|"~     This is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of~     Taxotere in combination with Xeloda which is dose escalated during the first phase of the~     study (modified Fibonacci design) and fixed during the second phase.~      The primary objective of the phase 1 part is to define the dose recommended for the Phase II~     part of the study. The primary objective is to determine the response rate.~   "
209260|NCT00821899|"~     This project evaluates the effectiveness of the administration of autologous bone marrow~     blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After~     mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow~     blood will be obtained by multifunction in the posterior iliac crest. The material obtained~     will be implanted into the pancreas through the magna pancreatic artery after femoral~     catheterization.~   "
209261|NCT00821886|"~     In this phase II trial the investigators propose to evaluate ixabepilone in combination with~     carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer~     patients. Patients with early stage, HER2-positive breast cancer will receive six cycles of~     neoadjuvant treatment with ixabepilone, carboplatin, and trastuzumab every three weeks prior~     to surgery; after surgery, patients will continue treatment with trastuzumab every three~     weeks until week 52. Concomitant with the post-operative trastuzumab treatment, patients with~     hormone receptor-positive tumors will receive anti-estrogen treatment. Also, after the~     completion of chemotherapy, patients may receive radiation treatment at the discretion of~     their physician.~   "
209262|NCT00821873|"~     The main objective of this study is to test the ability of an allograft plug to provide a~     successful repair of an osteochondral defect left at the harvest site during OATS procedure.~   "
209263|NCT00821860|"~     RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of~     the chest cavity may be effective in treating pleural effusion and cause less damage to~     normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is~     not yet known which therapy is more effective in treating pleural effusion caused by~     malignant mesothelioma.~      PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well~     it works compared with talc pleurodesis in treating patients with malignant mesothelioma.~   "
209264|NCT00821847|"~     Recent progress in antiretroviral therapy has turned HIV infection into a chronic disease.~     Patients survival has dramatically improved but complications may occur that need to be~     prevented and monitored. As much as 10 % of HIV patients may suffer from chronic kidney~     disease, an affection that is not symptomatic until a very late stage secondary to HIV~     infection, drugs exposure, hypertension or diabetes. Guidelines have suggested that renal~     function should be regularly assessed in HIV patients to perform early diagnosis for chronic~     kidney disease and allow initiation of preventive measures aimed at preserving renal~     function.~      Plasma creatinine dosage is the easiest way to evaluate renal function but glomerular~     filtration rate estimation from cockcroft or MDRD formulae is a much better indicator of~     renal function. Other markers like cystatin C may be used. None of these markers has been~     validated in HIV patients. Therefore our study is aimed at comparing validity of creatinine~     clearance estimation with Cockcroft and Gault and MDRD formula and cystatin C compared to the~     gold standard measurement of glomerular renal function.~   "
209265|NCT00821834|"~     Primary objective:~        -  To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower~          risk of the safety events of interest in patients with stable angina (SA) or old~          myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being~          planned.~      Secondary objectives:~        -  To compare the incidence of adverse events, adverse drug reactions and bleeding events~          in patients treated with clopidogrel versus ticlopidine.~        -  To compare the incidence of major adverse cardiac events (MACE) and major adverse~          cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus~          ticlopidine.~        -  To evaluate the long-term safety (adverse drug reactions, adverse events, safety events~          of interest and bleeding events) of clopidogrel for a total of 52 weeks;~        -  To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.~   "
209266|NCT00821821|"~     The objectives of this study are to assess the safety, tolerability and local tolerance, and~     to investigate the plasma levels and terminal elimination half life of MCI-186, and to review~     the routine clinical and neurological assessments data of MCI-186 in subjects with acute~     ischemic stroke.~   "
209267|NCT00821808|"~     This phase I Healthy Volunteer study will evaluate the pressure interface between the devices~     (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer~     at specified time intervals in three distinct locations on the leg, in both the sitting and~     standing position. It will also assess the variability of interface pressure following~     application under each test device for each subject over a period of three days (three~     separate applications).~   "
209268|NCT00821795|"~     Volunteers are being invited to take part in a research study about insulin therapy of~     diabetes. They are being invited to take part in this research study because they have~     diabetes and have an illness requiring hospitalization. If they volunteer to take part in~     this study, they will be one of about 120 people to do so. The investigators hope to answer~     the following research questions:~        -  To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin~          NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the~          hospital.~        -  To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg~          70/30 mix) and how well they work for the treatment of diabetes when transitioning from~          inpatient therapy to outpatient care.~   "
209269|NCT00821782|"~     Evaluation of bacteria in the mouth and throat before study drug ( Levofloxacin,~     floroquinolone antibiotic and Azithromycin, a macrolide antibiotic) is started and then~     periodically for 6 weeks after the last dose of study drug is taken~   "
209270|NCT00821756|"~     Background:~      Repetition rate after a suicide attempt and self harm is very high, about 12-30 percent.~     Studies, reviewed by Hawton, 1999 show a lack of evidence for psychosocial interventions.~     Compliance with aftercare is also often very poor.~      Objective:~      Inspired by the Norwegian Baerum project, the aim is to study if active, assertive outreach,~     seeking contact, talking about problem solution, motivate to comply to other appointments,~     will reduce repetition of suicidal acts in the following years.~      Methods:~      The design is a prospective randomized, controlled trial. The patients (immediately after a~     suicide attempt or deliberate self harm)) included are randomized to intervention or standard~     (treatment as usual), aiming at at least 60 persons in each arm. The intervention is carried~     out through research nurses with about 8 home visits, phone contact, phone messaging,~     e-mails.Included are persons 12 years of age and older, danish speaking without translator~     and without diagnoses of severe mental illness (schizophrenia, bipolar illness, mania and~     severe/psychotic depression) or severe dementia.~      Results:~      Outcome is measured by repetition of suicidal act (suicide attempt, self harm or completed~     suicide)as recorded in medical records and by the Danish Cause of Death Register. Repetition~     measured by persons and by acts throughout 1 year, 2 and 3 years periods. Additional outcome~     is number and character of health system contacts.~   "
209271|NCT00821743|"~     Disturbance of posture, gait and balance usually appear several years after Parkinson's~     disease (PD) onset. These axial signs, generally resistant to conventional drug and non-drug~     treatment, can generate a loss of autonomy and traumatic complications. Improvement of these~     axial signs by deep brain stimulation (DBS) of the pedunculo-pontin nucleus (PPN) has been~     described for a small number of patients. The objectives of the present prospective~     monocentric pilot study are to determine the optimal stimulation parameters of PPN-DBS, to~     evaluate the long term tolerance and the effect of PPN-DBS on axial signs and quality of life~     in five patients with severe PD. The use of detailed clinical rating scales and quantitative~     computer-based gait analysis will allow to identify the optimal stimulation parameters and~     relevant clinical efficacy parameters, mandatory for the design of further comparative~     large-scale studies.~   "
209272|NCT00821730|"~     nflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist~     shortages, failure of primary care providers and individuals to recognize the disease, and~     lack of awareness of the importance of early intervention, delays to rheumatologic care are~     common. Peer support models have been used for various health issues and may be one method to~     assist individuals with early IA to manage their disease and cope with stress. One-on-one~     semi-structured interviews will seek out feedback on a peer support approach and explore the~     learning needs (informational needs, educational preferences) and opinions about emotional~     and appraisal support of individuals living with IA from the perspectives of family and~     friends. The data will be analyzed and expressed themes (articulated needs and understandings~     of interviewee context) will guide the future development of a peer support intervention.~   "
209273|NCT00821717|"~     This study is designed to assess, relative to placebo, the effects on the evolution of~     exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric~     carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic~     CHF (congestive heart failure) and iron deficiency.~   "
209274|NCT00821691|"~     The objective of the study is to test the action of the amantadine, as DOPA-agonist, in a~     double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post~     stroke aphasic patients.~   "
209275|NCT00821678|"~     The purpose of this study is improved outcomes for veterans with Post Traumatic Stress~     Disorder (PTSD) treated in small VA Community Based Outpatient Clinics (CBOCs). Although~     psychotherapy and pharmacotherapy treatments for PTSD have been proven to be efficacious in~     controlled trials, geographic barriers often prevent veterans from accessing these~     evidence-based treatments. Telemedicine technologies will be used to overcome geographic~     barriers to care. Specifically, we will evaluate the Telemedicine Outreach for PTSD (TOP)~     intervention which is based on the principals of the Chronic Care Model and Disease~     Management, and builds on the evidence base of quality improvement for depression in primary~     care settings. The TOP intervention will employ an off-site PTSD care team~     (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will~     use telemedicine technologies (telephone, interactive video and electronically shared medical~     records) to treat CBOC patients with a newly emerging or chronic PTSD. We hypothesize that~     study participants randomized to the TOP intervention will receive higher quality of care and~     experience better outcomes compared to study participants randomized to treatment as usual.~   "
209317|NCT00821119|"~     The purpose of this study is to evaluate the hypothesis that nasal intermittent positive~     pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will~     decrease the need for conventional endotracheal ventilation when compared to nasal continuous~     positive airway pressure.(NCPAP)~   "
209276|NCT00821665|"~     Hyperglycemia forms a direct and independent risk factor for the development of~     cardiovascular co-morbidities in type 2 diabetes. Consumption of sucrose-sweetened soft~     drinks might further increase the prevalence of hyperglycemic episodes.~      The objective of the study was to assess glycemic control in type 2 diabetes patients and~     healthy lean and obese controls under strict dietary standardization but otherwise free~     living conditions, with and without the consumption of soft drinks.~   "
209277|NCT00821652|"~     The study is designed to see if a course of injections containing the NY-ESO-1 protein (a~     tumor antigen, marker expressed by tumors); in combination with an immune stimulant~     (adjuvant) Montanide, with or without resiquimod (another adjuvant) is well tolerated and~     safe in patients with surgically resected Stage IIB, IIC, Stage III or Stage IV (AJCC~     criteria) melanoma, a tumor that expresses NY-ESO-1. In addition, this study is designed to~     see if the patient's body's defense (immune) system can be boosted (strengthened) by this~     vaccine and if the addition of resiquimod to the vaccine makes this more likely.~   "
209278|NCT00821639|"~     The purpose of this study is to assess the effects of a health center based counselling~     method for the prevention of infant exposure to secondhand smoke.~   "
209279|NCT00821626|"~     Influenza is a frequent cause of fever in returning travelers. Usually diagnosis rests on the~     clinical picture. Rapid flu tests are becoming increasingly popular, although their~     sensitivity and specificity are suboptimal. The objective of this study is to evaluate if~     rapid flu tests influence the medical management of returning travelers with fever, a~     population at intermediate risk for influenza infections.~   "
209280|NCT00821613|"~     Collection of thermal images of women with breast tumors in varying degrees of severity and~     of healthy women with no breast findings, in order to evaluate and improve Real Imaging's~     device (RI4.0), capabilities which will assist in early detection of breast cancer.~   "
209281|NCT00821600|"~     The purpose of this study is to explore the pharmacokinetics, safety and tolerability of a~     4-week long-acting injectable (LAI) formulation of risperidone after single intramuscular~     (i.m.) injection of 75 mg risperidone LAI in the gluteal muscle.~   "
209282|NCT00821587|"~     The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug,~     on the clearance of the hepatitis C virus in liver transplant subjects being treated with~     peg-interferon and ribavirin.~   "
209283|NCT00821574|"~     This study will evaluate the efficacy of a multi factorial preventive scheme of action~     (including fluvastatin and valsartan) to reduce the overall risk level in patients with~     metabolic syndrome.~   "
209284|NCT00821561|"~     The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with~     Persistent Epithelial Defects (PED) originally caused by chemical burns.~   "
209285|NCT00821548|"~     The investigators evaluated clinical tolerance, biological tolerance, feasibility and~     efficacy of daily electrostimulation training of shoulder girdle and quadriceps muscles in 10~     patients with facioscapulohumeral muscular dystrophy, the third most common inherited~     myopathy.~   "
209286|NCT00821535|"~     To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg~     maraviroc in healthy male Japanese volunteers.~   "
209287|NCT00821522|"~     Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its~     pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic~     preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing~     coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the~     incidence of acute kidney injury associated with cardiopulmonary bypass.~   "
209288|NCT00821509|"~     Improved hand hygiene is known to reduce transmission of both respiratory (RTI) and~     gastrointestinal infections (GTI) under semi-closed conditions such as hospitals, day-care~     centres and schools. It is not known if similar interventions would have the desired effect~     in a regular office work. This study is aiming to investigate this possibility by recruiting~     volunteers from several companies in the Helsinki Region. The two intervention groups will~     receive detailed instructions e.g. for proper coughing and sneezing, and for regular cleaning~     of hands with either standard liquid soap or with alcohol-based gel rubbing. Third group will~     serve as the control and is advised not to change their previous behaviour in this respect.~     The participants will report weekly possible RTI or GTI symptoms and related days off through~     internet. The study is planned to run about 18 months to cover the seasonal variation of the~     epidemics of the causative different viruses.~   "
209289|NCT00821496|"~     This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on~     Oral Contraceptive medication.~   "
209290|NCT00821483|"~     The purpose of this study is:~        1. To compare the efficacy of a single dose of Frovatriptan 2.5 mg with that of placebo in~          acute treatment of up to one migraine attract~        2. To assess recurrence rate between two group~        3. To assess the safety and tolerability~   "
209291|NCT00821470|"~     Aseptic non traumatic osteonecrosis (ON) is a painful disorder of the hip which often leads,~     in its final stage, to femoral head collapse and subsequent total hip replacement. Core~     decompression of the hip is the most widespread procedure used to treat early stage ON of the~     femoral head. Notwithstanding the fact that this procedure has been employed for more than~     three decades (2), its efficacy remains controversial (3;4). Recently, one suggested that ON~     might be a disease of bone cells and/or of mesenchymal cells. The levels of activity and the~     number of mesenchymal stem cells in both the hematopoietic and in the stromal compartments of~     the bone marrow have been shown to be depressed in patients with ON of the femoral head (9).~     The investigators have showed previously that the capacity of osteoblastic cells to replicate~     was decreased in the proximal femur of patients with ON of the femoral head (10). This~     finding raised the possibility that bone marrow containing stromal cells which have many of~     the characteristics of stem cell for mesenchymal tissues including bone could be implanted~     into the necrotic lesion of the femoral head.~   "
209345|NCT00820768|"~     To determine MTD and DLT of ABI-010 given weekly every three weeks followed by one week of~     rest (Cycle 1). Determine MLD and DLT in combination with ABI-007; to characterize the~     toxicities of ABI-010 alone and in combination with ABI-007.~   "
209472|NCT00819052|"~     The primary objective of this study is to demonstrate the efficacy of nevirapine extended~     release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine~     immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.~   "
209292|NCT00821457|"~     Renovo, a Biopharmaceutical company involved in the development of drugs to improve the~     appearance of scars and enhance wound healing, are proposing to carry out research in~     improving the appearance of existing scars that are 2-6 months old using Juvista. Juvista has~     not previously been administered to pre-existing scars without surgical revision, but it is~     thought that some beneficial effects seen with Juvista in previous trials may also be seen~     when administered to existing scars whilst the scar is maturing. This proof of concept study~     will therefore investigate the effect of Juvista in Caucasian male and female patients when~     administered to scars that are between two and six months old.~      Scarring in the skin can vary hugely between individuals; therefore the most reliable way to~     assess the efficacy of an improvement of scar appearance is to use a model where each patient~     acts as their own control. A placebo will also be used for this trial as there are currently~     no approved pharmaceuticals for the improvement of scarring.~      A total of 20 patients will be allocated to one of two dosing groups. Patients who enter the~     study will have linear scars resulting from broken skin (e.g. trauma, surgery) between 7 and~     20cm in length, as well as meeting other specific criteria. The scar to be treated will be~     divided into two equal segments. Each segment will receive an intradermal injection of~     Juvista or placebo on Day 0 and 24 hours later.~      The measure of change in scar appearance will be performed using colour analysis which will~     assess the change in colour between the Juvista treated segments versus the placebo treated~     segment of the scar, with reference to the surrounding skin within each patient.~   "
209293|NCT00821444|"~     Commercial ziprasidone capsules show a large increase in bioavailability with food. The~     formulation tested in this study aims to reduce or eliminate that increase.~   "
209294|NCT00821431|"~     A prospective, Phase II, stratified, randomized study to compare the safety, ulcer healing,~     patient compliance (concordance) and resource utilisation of a compression device with IPC~     mode to a Class 3(c) UK standard graduated compression regime (4- layer system) on subjects~     with venous leg ulcers.~   "
209295|NCT00821418|"~     The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™~     on patients with COPD, as measured by the change from baseline in full pulmonary functions,~     oxygen saturation, exercise tolerance and health related quality of life; and to assess the~     ease of use of PulseHaler™ by the patients.~   "
209296|NCT00821405|"~     Use ultrasound and computed tomography to evaluate the condition of peritoneum(thickness,~     calcified, etc. )and correlate the relationship between the peritoneum and other clinical~     condition~   "
209297|NCT00821392|"~     This study was designed to evalute the efficacy and safety of Febuxostat after oral~     administration to patientd with gout in Korea~   "
209298|NCT00821379|"~     The CoPPer study is a follow-up study of women diagnosed with Polycystic Ovary Syndrome~     (PCOS). Women will be included pre-conceptional and followed-up until after delivery. The~     investigators will design a multivariate prediction model of pregnancy outcome in women with~     PCOS with the intention to define intervention strategies for the future.~   "
209299|NCT00821366|"~     The aim of this study is to investigate the benefits of ARV treatment to patients, to the~     family members of patients on ARV treatment, and to communities at large. The study also aims~     to investigate the impact of a peer adherence support and a nutritional intervention on~     measures of treatment success. To this end, 648 patients who had commenced ARV treatment in~     the past month at twelve selected health care facilities will be recruited into the study. In~     addition, 204 randomly sampled households from the communities served by the twelve selected~     clinics will be recruited into the study. Trained enumerators will at baseline conduct~     semi-structured interviews with patients and households. Following the baseline survey,~     patients recruited into the study will be randomly assigned to one of three groups:~        -  Patients receiving ARV treatment and the associated support currently provided in the~          public sector ARV treatment programme.~        -  Patients receiving (a) plus bi-weekly visits by an experienced ARV patient who has been~          trained as a peer adherence supporter~        -  Patients receiving (a) and (b) plus a weekly nutritional supplement in the form of two~          400g cans of meatballs and spaghetti in tomato sauce The group of 'comparison'~          households comprises the fourth group. Trained enumerators will conduct follow-up~          interviews with all patients and households at approximately six- and at twelve-months~          respectively. In addition, the ARV coordinator and other providers working in the ARV~          treatment programme at each of the twelve selected health care facilities will be~          interviewed by trained enumerators, at baseline and again at six- and at twelve-months.~          Clinical data will be obtained from patient files at baseline and at completion of the~          study. Using these data, various outcomes of importance to the study will be compared~          between the four study groups, using experimental and non-experimental methods.~   "
209300|NCT00821353|"~     Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients~     with hypertrophic cardiomyopathy (HCM) and represents an important complication in the~     clinical course of the disease, with adverse long-term consequences on functional status and~     outcome.~      Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus~     rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is~     challenging because of the limited long-term efficacy and potentially hazardous side effects~     of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is~     successfully used in clinical practice. However, comparison of the efficacy and safety of~     these two therapeutic options has not been done up till now in randomized manner in this~     group of patients.~      Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs.~     antiarrhythmic drug therapy in patients with HCM and AF.~   "
209301|NCT00821340|"~     The purpose of this clinical trial is to examine the safety of gene therapy for Lebers~     Congenital Amaurosis (LCA) caused by RPE65 mutations using a recombinant adeno-associated~     virus serotype 2 (rAAV2) vector carrying the human RPE65 (hRPE65) gene. Recently, three~     independent short-term gene therapy studies in humans with LCA due to RPE65 mutations were~     published, suggesting that subretinal delivery of rAAV virus carrying the RPE65 gene is safe.~     As a secondary outcome, improvement in visual function was observed in seven of the first~     nine treated patients. The proposed study is a similar open label, Phase I clinical trial of~     uniocular subretinal rAAV2-hRPE65 administration to individuals with RPE65-associated retinal~     disease. Two cohorts of three subjects each and one cohort of four subjects will be included~     in this trial. Cohort 1 and 2 will consist of individuals 18 years of age and older and~     Cohorts 3 will consist of individuals 8 years of age and older. In cohort 2, a larger volume~     of vector will be administered. Enrollment in Cohort 3 will begin only after confirming the~     safety of rAAV2-hRPE65 administration in the older group of participants.~   "
209302|NCT00821327|"~     The primary objective of this nonrandomized Phase II study is to evaluate the objective~     response rate (ORR, CR+PR) in patients with advanced/metastatic UC treated with the~     combination of gemcitabine, cisplatin, and sunitinib.~   "
209373|NCT00820404|"~     The purpose of this study is to evaluate the safety, and tolerability of single doses of~     BLI-489 administered intravenously in healthy subjects, and also how the drug is absorbed and~     eliminated.~   "
209303|NCT00821314|"~     Importance of the problem OAB is a common health problem. Milsom et al. [1] randomly selected~     a population from six European countries. From this population, 17% of the respondents~     reported having OAB symptoms with 14% reporting frequency, 9% urgency, and 6% urge~     incontinence. The study by Milsom et al. [1] showed that OAB adversely affected the lives of~     the majority (65%) of the respondents who reported OAB symptoms. Chen et al. [2] also~     reported that the prevalence of OAB in Taiwanese women was similar to that of Western women.~     In the study of Chen et al.[2], the prevalence of OAB was 18.6% for the patients; perceptions~     and the number of OAB condition significantly increased in the elderly women (over 65 years~     old, 39.3%). Apart from impairing the physical health, OAB may have a tremendous effect on~     psychological and social well-being. Information on the symptoms and disease severity can~     yield important information that often complements objective measures.~      Incontinence, increased urge and increased frequency of micturition affect nearly 100 million~     people in the western world (33 million in the US and 66 million in the European Union).~     These conditions are not life threatening but they seriously affect quality of life and~     ability to work. OAB is in some studies reported to have an incidence of up to 17 % in the~     western population with great consequences for the quality of life.~      Economic cost The total economic cost of this group of conditions is high. In 2002 the costs~     in the US were approximately $12.7 billion[1] (estimated to be $17 billion and €22~     billion/year in 2005). Approximately 25% of this expenditure is spent on treatment (drug~     therapy, clinical consultation and surgery). Of those who suffer only 28% have sought help~     and only half of those currently receive treatment. Less than 3% regain long lasting normal~     control. Therefore, these costs are an under-estimate and the problem is large.~      Aetiology~   "
209304|NCT00821301|"~     The purpose of this study is to evaluate the safety and tolerability of fluphenazine in~     patients with advanced multiple myeloma. The study will also describe the efficacy of this~     drug.~   "
209305|NCT00821288|"~     The overall goal of this proposal is to improve the post-treatment care of breast cancer~     survivors and to understand the barriers to optimal post-treatment care in Latina and~     Non-Hispanic women.~   "
209306|NCT00821275|"~     The efficacy and safety of uterine artery embolization, as compared with standard surgical~     methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of~     this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief,~     complication, fertility, ovarian function and quality of life with uterine artery~     embolization for uterine fibroids comparing with standard surgical methods.~   "
209307|NCT00821262|"~     Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be~     randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane.~      The investigators want to document whether the cardioprotective properties of volatile agents~     could translate in an improved outcome after cardiac surgery in high risk patients.~   "
209308|NCT00821249|"~     This is a 2-phase study during which patients with relapsed or refractory multiple myeloma~     (MM) or plasma cell leukemia (PCL), who have already received at least two previous~     treatments, will receive investigational study drug ARRY-520.~      The study has 3 parts. In the first part of the study, Phase 1, patients will receive~     increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF)~     support, in order to achieve the highest dose possible that will not cause unacceptable side~     effects. Approximately 30 patients from the US will be enrolled in Part 1 (Active, not~     recruiting).~      In the second part of the study, Phase 2, patients will receive the best dose of study drug~     determined from the first part of the study and will be followed to evaluate what side~     effects the study drug causes and what effectiveness it has, if any, in treating the cancer.~     Approximately 30 patients from the US will be enrolled in Part 2 (Active, not recruiting).~      In the third part of the study, Phase 2 with Dexamethasone, patients will receive the best~     dose of the study drug determined from the first part of the study, in combination with~     dexamethasone, and will be followed to evaluate what side effects the combination causes and~     what effectiveness the combination has, if any, in treating the cancer. Approximately 50~     patients from the US will be enrolled in Part 3 (Active, not recruiting).~   "
209309|NCT00821236|"~     The purpose of this study is to compare LASIK outcomes using the WaveLight ALLEGRETTO WAVE™~     wavefront guided or optimized excimer laser treatment with the AMO/VISX CustomVue™ and the~     LADARVision 4000 excimer laser treatment.~      Standard refractive outcomes such as uncorrected and best corrected visual acuity, and~     intended vs. achieved postoperative refractions will be evaluated; in addition, high order~     optical aberrations, contrast sensitivity, and topography will be measured.~   "
209310|NCT00821223|"~     Hypothesis :~      Phacoemulsification is superior to SICS with regards to:~        -  Immediate unaided high and low contrast visual performance~        -  Its impact on quality of life.~   "
209311|NCT00821210|"~     Specific Aim~        1. To determine the prevalence of OSA in patients of first-time AMI in acute phase By~          screening patients of first-time, single-vessel disease, Killip I AMI, and successful~          revascularization~        2. To determine the impact of CPAP treatment on the prognosis of AMI Using sham CPAP as the~          optimal placebo, we conduct this randomized, double-blind, placebo controlled trial to~          assess the 12-week CPAP effect in moderate-severe OSA patients.~        3. To determine how the OSA affects patients with MI in acute and chronic phase and vice~          versa, which is dissected from mechanical basis and molecular basis By comparing the~          clinical parameters of AMI patients without OSA (AHI<5/hr), mild OSA (5 < AHI <15),~          moderate OSA (15<AHI<30) and severe OSA5 (AHI>30/hr), and before and after CPAP~          treatment, we can determine the interaction between OSA and AMI.~   "
209312|NCT00821197|"~     The main study objective:~      To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. distal gastric bypass~     (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2).~      The main study hypothesis:~      Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass~     1 year after surgery. Patients subject to distal bypass have more gastrointestinal side~     effects and more extensive nutritional deficiences compared to long-limb gastric bypass.~   "
209313|NCT00821184|"~     This study will help determine if behavior modification performed in conjunction with oral~     Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms~     than oral Vesicare anticholinergic therapy alone.~   "
209314|NCT00821158|"~     The investigators will examine whether administration of certain medications will decrease or~     prevent ischemia-reperfusion injury.~   "
209315|NCT00821145|"~     In many countries the gold standard for treating abdominal aortic aneurysms is still open~     surgery with a long incision. In patients with suitable anatomy alternatively an endovascular~     approach can be chosen. Since open surgery is more durable in many countries a laparoscopic~     procedure using  key hole surgery  has gained wider acceptance. The current study wants to~     prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with~     reduced recovery times.~   "
209318|NCT00821106|"~     Transradial approach of cardiac catheterization is a common alternative to transfemoral~     access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The~     transradial approach reduces access site bleeding complications and the procedural discomfort~     of the patients. Transradial procedures may be performed by cannulation of the right or left~     radial artery and at present, the choice of the right or left radial artery depends largely~     on the operator' s preference.~      The aim of this study is to evaluate safety and efficacy of transradial approach comparing~     the right radial versus the left radial approach in coronary diagnostic and interventional~     procedures.~      The investigators will enroll consecutively for 12 months all patients who undergo to~     diagnostic or interventional procedures through trans radial approach in two Italian centers~     (Casilino Policlinic, Catholic University-Rome).~      Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the~     patients. Secondary end-points are: contrast amount, time to obtain the first angiography,~     procedural shift rate, number of catheters employed, major complications.~      The investigators pre-specified a sub-study in patients older than 75 years old with the same~     end-points.~   "
209319|NCT00821093|"~     This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.)~     versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with~     chronic obstructive pulmonary disease.~   "
209320|NCT00821080|"~     This study is evaluating a combination of drugs called sirolimus and vandetanib to treat~     glioblastoma. Sirolimus has been approved for use in patients who undergo organ transplants.~     Sirolimus works by suppressing the immune system so the body will not reject the transplanted~     organ. Vandetanib is an investigational drug and we are trying to find the highest and safest~     dose of vandetanib with sirolimus that can be given safely.~   "
209321|NCT00821067|"~     D-ribose, a natural occurring pentose carbohydrate, has repeatedly shown to enhance~     high-energy phosphates and improve function following ischemia, states of congestive heart~     failure, and recently in subjects with lung disease. An initial preliminary, open label pilot~     study demonstrated a positive benefit of D-ribose in Baby-Boomer subjects aged 50 to 65~     years old complaining of persistent fatigue. The objective of this study will build on the~     previously collected data to evaluate oral D-ribose vs. dextrose (administered as a~     supplement) in relatively healthy, yet fatigued subjects with a goal of improving their state~     of fatigue.~   "
209322|NCT00019539|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them.~      PURPOSE: Randomized phase II trial to determine the effectiveness of monoclonal antibody~     therapy in treating patients who have advanced kidney cancer that cannot be surgically~     removed.~   "
209323|NCT00821054|"~     This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability~     of lapatinib administered after a high or low-fat meal.~   "
209324|NCT00821041|"~     Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia,~     such treatments are underutilized. This study evaluates the impact of a 6-week, online~     treatment for insomnia.~      Design This is a randomized controlled trial with online treatment and waiting list control~     conditions.~      Participants~      Participants are adults in Manitoba Canada with chronic insomnia.~      Setting~      Participants receive online treatment from their homes. Intervention. Online treatment~     consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep~     restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help~     with medication tapering. Measurement and Results. The impact of online treatment on primary~     end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.~   "
209325|NCT00821028|"~     To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous~     techniques can be improved using paclitaxel.~   "
209326|NCT00821015|"~     Atrial fibrillation is a common and disabling irregular heart rhythm, that affects 1 to 1.5~     million Americans. Recent clinical experience with the Medtronic Arctic Front™ Cardiac~     CryoAblation Catheter System suggests that it can be used to isolate the pulmonary veins~     (PVs) safely and effectively in patients with AF, thereby reducing or eliminating the~     recurrence of AF.3-4 However, the very large ablative surface of this balloon ablation~     catheter raises the possibility that this technique may damage extensive areas of the atrial~     myocardium.~      The LA is an elastic chamber, designed to expand and contract with ease to accommodate the~     influx and outflow of blood, while maintaining relatively low pressure. When exposed to~     stress or injury, whether acute or chronic, the LA may lose much of its elasticity, resulting~     in overall dilation accompanied by fibrosis in some cases. Overall, this may potentially~     result in diminution of LA mechanical function (both systolic contractile function, and~     diastolic relaxation function). In addition, LA function is linked to both Left Ventricular~     (LV) systolic and diastolic function, manifesting in an overall impact on cardiac remodeling,~     including the area of the pulmonary vein ostia, and a significant decrease in LV ejection~     fraction (LVEF). On the other hand, the positive effects of maintaining sinus rhythm with~     successful catheter ablation of AF may result in improvement of LA mechanical function.5-9~      Based on the potentially deleterious effects of damage caused by cryoablation, to the atrial~     myocardium during balloon ablation, this prospective, non-randomized, single-center study has~     been designed to assess the atrial effects of balloon cryo-ablation.~   "
209327|NCT00821002|"~     The study objective is to compare IOP and safety outcomes based on plug placement (upper or~     lower puncta).~   "
209328|NCT00820989|"~     The body's immune response to injury or infection is very complex.Endotoxin is a man-made~     substance, which causes the body to mimic sickness (fever,chills, and achiness)for a few~     hours. This study is designed to determine whether certain proteins, genetics, or heart rate~     variability change affects the body's response to endotoxin.~   "
209342|NCT00820807|"~     This study will critically evaluate the effects of a novel dietary fiber administered to~     subjects at high risk for developing diabetes to determine if this intervention will improve~     insulin sensitivity compared to control product administration and, thus, decrease risk for~     developing diabetes.~      The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly~     decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic~     subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening)~     compared to consumption of the control product.~   "
209329|NCT00820976|"~     Background The effects of granulocyte colony-stimulating factors (G-CSF) on recovery~     following induction chemotherapy are widely accepted. However, their impact on response and~     survival has not been clarified yet. Male gender has been claimed to be a susceptibility~     factor for development of leukemia and shorten survival but effect of sex has not been~     analyzed in clinical trials utilizing G-CSF.~      Design and Methods Efficacy and safety of G-CSF as an adjunct to de novo AML remission~     induction therapy was assessed in this prospective randomized Phase III multicenter trial.~     Patients were randomized to receive induction therapy consisting of either cytosine~     arabinoside 100mg/m2/d, days 1-10 and idarubicin 12 mg/m2/d, days 1-3 (control arm) or plus~     G-CSF (Filgrastim, 5 µg/kg/d starting from day 8 until absolute neutrophil count (ANC) over~     0.5x109/L for two consecutive days) for a median duration of 14 days (G-CSF arm).~      After achievement of CR, all patients received first consolidation course of Ara-C 1~     gr/sq.m/d (d1-5) and Ida 12 mg/sq.m/d (d1-3). If patients did not have an HLA identical donor~     they were randomized to receive second course of consolidation either high dose Ara-C 3~     gr/sq.m/d (d1, 3, 5) or G-CSF for collection of stem cells for the consecutive PBSCT.~   "
209330|NCT00820963|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy in higher doses over a shorter period of time may kill more tumor cells and have~     fewer side effects. Drugs used in chemotherapy, such as temozolomide, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. It is not yet known whether standard radiation therapy, higher-dose radiation~     therapy, or chemotherapy is more effective in treating older patients with glioblastoma~     multiforme.~      PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how~     well it works compared with higher-dose radiation therapy or chemotherapy in treating older~     patients with glioblastoma multiforme.~   "
209331|NCT00820950|"~     The study is comprised of two parts. The first portion of this study will be a double-blind,~     Sponsor-unblinded, vehicle-controlled study with application of INCB018424 or vehicle to~     paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part~     2 of the study is a double-blind, sponsor unblinded, comparison of INCB018424 with two FDA~     approved products in patients with active but stable plaque psoriasis.~   "
209332|NCT00820937|"~     The aim of this study is to improve the diagnostic of Lewy body dementia by combining the~     scintigraphy (SPECT) usig a spécific transporter and magnetic resonance imaging (MRI).~   "
209333|NCT00820924|"~     The underlying biology of the various patterns of metastasis observed in different tumour~     types remains unclear. The detection and characterization of circulating tumour cells in~     cancer patients has provided important new information about the progression of metastatic~     events. This information has important implications for cancer prognosis and therapy.~      This multicenter open-label study is designed as a two-stage three-outcome phase II trial.~     The aim is to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast~     cancer patients with HER-2 non-amplified primary tumours and HER-2 or EGFR positive~     circulating tumour cells. Evaluation of HER-2 and EGFR status on circulating tumour cells~     will be performed by the means of the CellSearch equipment (Immunicon, Huntingdon Valley, PA,~     USA) and FISH method (PathVysion Kit -Abbott Laboratories).~   "
209334|NCT00820911|"~     This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free~     (calcineurin inhibitor) regimen in renal transplant recipients.~   "
209335|NCT00820898|"~     This phase II trial is studying the side effects of gemcitabine and to see how well it works~     in treating patients with recurrent or persistent endometrial cancer. Drugs used in~     chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~   "
209336|NCT00820885|"~     The primary objective of the study was to study the safety and tolerability of teduglutide~     following a once or possibly twice daily subcutaneous injection for eight consecutive days in~     healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide~     following a once or possibly twice daily injection for eight consecutive days in healthy~     subjects.~   "
209337|NCT00820872|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together~     with carboplatin, trastuzumab, and lapatinib may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with~     carboplatin, trastuzumab, and lapatinib in treating patients with early stage breast cancer.~   "
209338|NCT00820859|"~     The purpose of this study is to examine the efficacy of non-pharmacological ways to treat~     agitated behaviors in nursing home residents with dementia. The hypothesis is that~     non-pharmacological interventions will be more effective than placebo in decreasing such~     behaviors.~   "
209339|NCT00820846|"~     The purpose of this study is to evaluate the safety of and immune response to a two-vaccine~     regimen in healthy, HIV-uninfected adults who have never received an HIV preventive vaccine~     before.~   "
209340|NCT00820833|"~     The purpose of this study is to determine whether infants, from overweight or obese mothers,~     fed a formula with proteins and calories different than a standard infant formula have a~     different growth~   "
209341|NCT00820820|"~     Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent,~     and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a~     temporary immunosuppression; furthermore, an improvement of AD has been observed during~     measles infection.~      This trial is aimed at demonstrating that measles vaccine is able to create an~     immunomodulation and to improve AD symptoms.~      30 adult patients of both sexes with moderate to severe AD will be randomly assigned to~     measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days.~      The primary outcome is the effect of anti-measles vaccination on the T cell responses in~     patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the~     evolution of blood level of measles specific IgE and antibodies; evolution of other~     biomarkers and phenotypic characteristics of T lymphocytes.~   "
209346|NCT00820755|"~     This open-label, randomized, multinational, non-comparative, phase IIIb trial with 2 parallel~     groups will screen about 1400 subjects with stage IIIB non-small cell lung cancer (NSCLC)~     with pleural effusion or stage IV NSCLC. It is expected that of approximately 1200 (85~     percent) subjects who will be included, about 1000 will be Caucasian; about 120 Asian, and~     the remainder (about 80) will be of other ethnic origin (that is neither Caucasian nor~     Asian). Approximately 480 (40 percent) subjects are expected to be free of progression at the~     end of combination treatment with cetuximab and platinum-based chemotherapy. These subjects~     will be eligible for randomization to intravenous cetuximab maintenance therapy with either~     500 milligram per square meter (mg/m^2) every 2 weeks or 250 mg/m^2 weekly (q1w); about 240~     subjects are expected per group.~      The trial will be performed in a community practice setting, with approximately 230 centers~     participating in the trial worldwide (planned countries are Argentina, Australia, Austria,~     Belgium, Brazil, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hong Kong,~     Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Russia,~     Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey, United~     Kingdom and Venezuela). With noncompetitive enrollment, approximately 4 to 8 subjects are~     expected to be enrolled at each center. Enrollment in the individual centers is generally~     limited to a maximum of 8 subjects. If any of these subjects does not receive trial treatment~     for any reason or discontinue all trial treatment at the first visit, additional subjects may~     be enrolled until 8 subjects were treated. The primary endpoint of the trial will be overall~     survival time from inclusion into the trial to death. Additional secondary efficacy endpoints~     will be time to treatment failure, tumor response, and disease control rate. Other endpoints~     will include safety and toxicity, compliance with maintenance therapy, subject satisfaction~     and translational research (TR) (for subjects with tumor samples available).~   "
209347|NCT00820742|"~     An open label, non-comparative, multicenter, non-interventional, post marketing surveillance~     study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the~     treatment of Filipino patients with neovascular age-related macular degeneration based on~     incidence of adverse events and to evaluate the efficacy based on visual acuity, and the~     patient's and physician's overall satisfaction with tolerability and efficacy.~   "
209348|NCT00820729|"~     The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of~     patients with interstitial pulmonary disease.~      The aim of this study is to estimate the frequency of an increased blood pressure in the~     lungs among patient with interstitial pulmonary disease, and to evaluate the use of different~     biomarkers in diagnosis of the condition.~   "
209349|NCT00820716|"~     The aim of the study is to compare two methods of exercise training: alternate load versus~     constant load realized at moderate or high intensities, in order to define the interests and~     the limits of each one of these two methods. The finality is to make possible to the expert~     to choose what exercise training induces the best results quickly and to make its choice~     according to the therapeutic objectives which it lays down.We also evaluate the effects of~     these exercises training on the vagal response and the bronchial tone of the asthmatics. From~     a clinical point of view, a close attention will be paid to the effects of these exercises~     training on the control of asthma and the quality of life of the subjects~   "
209350|NCT00820703|"~     Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time~     during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is~     increased 8-fold in people with diabetes. New treatments that improve the number of ulcers~     that heal and/or speed up healing are urgently needed. Initial studies with a new drug called~     Nexagon® (developed by CoDa Therapeutics, Inc.) support the concept that healing of diabetic~     foot ulcers can be improved with topical application of Nexagon®. Further research will be~     undertaken to assess the safety and activity of Nexagon® when applied to diabetic foot ulcers~     at various doses. A proposed randomized controlled trial will randomly allocate (e.g., by the~     toss of a coin) 24 people with diabetic foot ulcers to Nexagon® (one of three different~     doses) or vehicle (substance containing no medication) to be applied to their ulcer three~     times over four weeks. Participants will be followed over four weeks to monitor their~     response to the treatment, specifically with regards to the amount of healing that occurs.~   "
209351|NCT00820690|"~     The purpose of this study is to analyze gene expression signature and immunohistochemical~     markers associated with clinical and pathological response to neoadjuvant chemotherapy in~     locally advanced breast cancer.~   "
209352|NCT00820677|"~     This is a randomized, controlled trial to test the use of an educational video during the~     newborn well-child visit. Parents who watch the video during their medical visit will be~     compared to those parents who receive traditional paper handouts. Measures obtained at~     baseline and 2-week follow-up include knowledge of infant development, self-efficacy with~     infant care, and problem-solving skills.~   "
209353|NCT00820664|"~     The purpose of this study is to examine the effect of two different dose levels of estrogen~     or placebo in healthy postmenopausal women by measuring the changes in hormone levels and~     examining the changes in the uterine lining (endometrium).~   "
209354|NCT00820651|"~     The purpose of the study is to evaluate whether the addition of Diamel, a nutritional~     supplement, to hypocaloric diet and exercise could improve the histological results~     (steatosis, necro-inflammatory activity and fibrosis), insulin resistance, aminotransferase~     levels and anthropometric measures in comparison with a placebo-controlled group with~     hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic~     steatohepatitis.~   "
209355|NCT00820638|"~     Up to 25 subjects will use the Myomoe100 in the home setting under the distant supervision of~     an occupational therapist. We will look to see if they can perform functional activities~     safely without adverse events.~   "
209356|NCT00820625|"~     The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase~     from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition~     to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing~     persistent AF.~   "
209357|NCT00820612|"~     Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic~     retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of~     disorders of the pancreas and bile duct.~      Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered~     rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to~     definitively determine whether rectally administered indomethacin (a non-steroidal~     antiinflammatory drug)is effective at preventing pancreatitis after ERCP.~   "
209374|NCT00820391|"~     The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation~     protocol in treating traumatized children in Sri Lanka when applied by locally trained~     teacher counsellors.~   "
220833|NCT00668239|"~     This study compares the use of intravitreous triamcinolone and laser therapy to treat~     maculopahty in patients with type 2 diabetes mellitus in a short-tem period of 6 months~   "
209358|NCT00820599|"~     A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating~     the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; study valve), its~     transfemoral delivery system, and crimper accessories. The trial includes a premarket~     confirmatory cohort to evaluate the system performance as well as a Post Market Clinical~     Follow-up phase involving expanded enrollment and long-term follow-up of all patients to~     evaluate valve performance out to 5 years.~   "
209359|NCT00820586|"~     A randomized study to assess the safety, feasibility and effectiveness of direct~     intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear~     cells or selected CD34+ cells in patients with refractory angina pectoris.~   "
209360|NCT00820573|"~     In patients with type 2 diabetes with inadequate glycemic control on diet and exercise after~     6 weeks of treatment:~      Objective: To assess the effects of co-administration of sitagliptin and metformin compared~     to placebo on hepatic glucose production (HGP).~      Hypothesis: After 6 weeks of treatment, the co-administration of sitagliptin and metformin~     provides greater reduction in hepatic glucose production (HGP) compared to placebo.~   "
209361|NCT00820560|"~     To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28~     days and to determine if a higher MTD can be established when INCB007839 is administered in~     combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment~     interruption every two weeks.~   "
209362|NCT00820547|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving~     bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after~     surgery.~      PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before~     surgery and bevacizumab and radiation therapy after surgery to see how well it works in~     treating patients with inflammatory breast cancer.~   "
209363|NCT00820534|"~     Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours~     in preventing the appearance of classical lesions following prodromal symptoms (tingling or~     burning sensation) based on thermographic assessment among recurrent cold sore sufferers.~   "
209364|NCT00820521|"~     The purpose of this study is to assess the safety and tolerability of ascending single oral~     doses of GAP-134 in healthy subjects, to provide the initial pharmacokinetic profile of the~     oral formulation of GAP-134 in healthy subjects, and to evaluate the effect on the~     pharmacokinetic profile of a high-fat meal of 450 mg of GAP-134 administered to healthy~     subjects.~   "
209365|NCT00820508|"~     The purpose of this study is to determine whether the histone deacetylase inhibitor CHR-2845~     is tolerated in patients with haematological diseases and lymphoid malignancies.~   "
209366|NCT00820495|"~     The purpose of this record is to test whether (a) participants who receive a Web-based~     smokeless tobacco cessation intervention will be more likely to be abstinent than~     participants who do not receive this intervention, and (b) whether participants who receive a~     telephone quitline intervention will be more likely to be abstinent than participants who are~     not in a quitline intervention.~   "
209367|NCT00820482|"~     The present study aims to elucidate if the FSH and LH activity contained in hMG preparations~     is comparable to the recombinant FSH and LH administration in a 1:1 ratio. The mean outcome~     is the corresponding ovarian response in terms of oestradiol increase during stimulation and~     number of mature follicles the day of hCG administration. The patients will be included and~     randomized into two groups and stimulated either by HMG injections started on day 3 at a dose~     of 75 IU every day and fixed for the first 5 days, and in the second group, rFSH and rLH~     injections be started on day 3 at a dose of 75 UI/day of rFSH + 75UI/day of rLH. Serum~     estradiol levels will be measured on stimulation day 1, day 6 and the day of hCG injection.~     All follicles greater than 14 mm of diameter will be recorded on hCG day Intrauterine~     insemination is performed during two consecutive days starting the day after the human~     chorionic gonadotrophin (Ovitrelle) injection. Secondary outcomes are Days of stimulation,~     Total doses of gonadotrophins administrated, Clinical pregnancy , Ongoing pregnancy and~     Miscarriage rate, and Cancellation rate.~   "
209368|NCT00820469|"~     Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune~     disorders. In some cases such as treatment of humoral acute rejection of renal transplant,~     thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often~     associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by~     plasma exchange but the knowledge is poor in this matter.~      The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of~     rituximab.~      The results of this study should conclude if plasma exchange leads to a significant decrease~     of plasma concentration of rituximab or not, and if the decreased of the concentration is~     associated with a decrease in efficacy.~   "
209369|NCT00820456|"~     The objectives for this study include:~        -  Testing a unique way of imaging people with colorectal cancer and other cancers that has~          spread to the liver using magnetic resonance imaging (MRI);~        -  Seeing if the MRI process can be used across multiple imaging platforms;~        -  Determining whether the results of the imaging can be reproduced;~        -  Reviewing how MRI results relate to cancer response to combination therapy and to~          clinical endpoints.~   "
209370|NCT00820443|"~     The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip~     when compared to a TRANSCEND® historical control group of patients with primary total hip~     replacement.~   "
209371|NCT00820430|"~     The objectives of this study are: to identify and develop techniques to minimize precision~     errors in magnetic resonance imaging (MRI) evaluation of knee cartilage, and to determine if~     results from newly-identified MRI techniques in measuring cartilage changes and structure can~     be reproduced.~   "
209372|NCT00820417|"~     This is an open-label, phase 1, non-randomised, non-controlled trial, carried out in two~     centres on patients with advanced cancer expressing EGFR. Primary objective is the~     determination of the maximum tolerated dose (MTD) and recommended dose (RD) of the~     combination of intravenous Cetuximab and oral Gefitinib.~   "
209375|NCT00820378|"~     Aortic aneurysms are the major disease processes affecting the aorta and becoming a~     relatively common cause of death because of rupture or dissection. The most common location~     for aneurysms is the infrarenal abdominal aorta, followed by the ascending thoracic aorta.~     Unlike coronary heart disease, the incidence of abdominal aortic aneurysm (AAA) in the United~     States and Europe has been increasing, and this increase may not be due to higher levels of~     screening for this condition alone. Aortic diameter is central to the diagnosis of aortic~     aneurysm. Furthermore, it was demonstrated that non-AAA patients with an enlarged diameter of~     the infrarenal aortic diameter are also at high risk for all-cause mortality. And aortic root~     dimension was associated with several coronary artery disease (CHD) risk factors and measures~     of subclinical disease and was predictive of incident congestive heart failure (CHF), stroke,~     cardiovascular disease (CVD) mortality, and all-cause mortality, but not of incident MI. Up~     to now, there are limited studies on the epidemiology of aortic diameter, especially in~     Chinese population.~   "
209376|NCT00820365|"~     This is an exploratory, open-label, uncontrolled, multi-center, 1-arm study conducted at 16~     sites in Bulgaria, Germany and Romania.~      A total of ca. 30 - 35 patients will receive SC12267 (4SC-101) tablets, 35 mg once daily for~     12 weeks. First of all the patients will undergo a screening period of 1 week and a follow-up~     visit will be performed 4 weeks after study drug discontinuation or earlier in case of~     relapse during follow up. Total study duration will be up to 36 (+2) weeks.~      There will be 8 study visits: one screening visit, 6 visits during the treatment period and~     one follow-up visit. In addition, four telephone visits will be performed at Week 6, Week 10,~     Week 20 (+1) and Week 36 (+2).~      The duration of the entire study (first patient in till last patient out) is expected to be~     about 13 months.~   "
209377|NCT00820352|"~     Heart failure is a major medical and socioeconomic problem in western industrial countries,~     especially with aging populations. Heart failure with normal left ventricle systolic function~     (heart failure with preserved ejection fraction, HFPEF, heart failure with normal ejection~     fraction, HFNEF) are common causes of hospitalization mainly in the elderly population and~     are frequently associated with pulmonary hypertension. It is commonly seen, that patients~     with left heart disease and pulmonary hypertension with right ventricle dysfunction have a~     worse prognosis.~      The investigators hypothesize, that an additional treatment with Bosentan in this patients~     will improve their exercise capacity, symptoms, hemodynamics and quality of life.~   "
209378|NCT00820339|"~     To confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the~     hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing~     hepatectomy by SHVE.To evaluate that SHVE can improve survival in HCC patients or not.~   "
209379|NCT00820326|"~     This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by~     intravenous way once a day during a 4 days Hospitalization.~      This study is double blind (neither you nor the physician will know if you are receiving~     active study drug or placebo).~      Randomisation at the beginning of the study will decide whether you receive active treatment~     or its placebo.~      This treatment will be renewed after one month, after 2 months and after 3 months.~      If the study staff determines that you are eligible and you decide to participate, there will~     be approximately 6 study visits in about 9 months. During these visits, you will undergo~     routine health exams and complete different kinds of questionnaires.~      Following this first period of 3 months, you agree to come back for consultation at month 4,~     month 6 and month 12 for monitoring and evaluating the effects of treatment.~   "
209380|NCT00820313|"~     The primary aim of the proposed research is to examine the relationship of lifestyle changes~     to new dietary, biomedical, and cellular parameters among new enrollees entering the Dr.~     Dean Ornish Program for Reversing Heart Disease program at 5 selected sites. Specifically,~     the investigators will add assessments of emerging cardiac risk factors (e.g., high~     sensitivity C-reactive protein [hsCRP], fibrinogen, lipoprotein(a) [Lp(a)], small, dense LDL,~     apolipoprotein B [apoB], apolipoprotein A-I [apo A1], the apoB/apoA1 ratio, homocysteine~     [Hcy], B-type natriuretic peptide [BNP], oxidized LDL, fasting insulin and waist-to-hip ratio~     [WHR]), protective and pathogenic dietary markers (e.g., folate, carotenoids, trans fatty~     acids), and measures of social support and cognitive functioning to the already existing~     assessment variables in the Multisite Cardiac Lifestyle Intervention Program (MCLIP).~      Hypothesis 1: Participation in the lifestyle program will not only be associated with~     favorable changes in standard coronary risk factors and quality of life, but also with~     improvements in emerging cardiac risk factors [hsCRP, Hcy, BNP, fibrinogen, Lp(a), small,~     dense LDL, apoB, apoA1, oxidized LDL, fasting insulin, and abdominal obesity] and~     psychosocial well-being (i.e., social support, and cognitive functioning).~      Hypothesis 2: High intake of emerging protective dietary factors and low intake of emerging~     pathogenic dietary factors will be associated with improvements in both standard and emerging~     cardiac risk factors (e.g. Hcy, oxidized LDL).~      Hypothesis 3: Degree of adherence to the lifestyle change program will be associated with~     differential improvement in standard coronary risk factors, emerging risk factors, cellular~     aging, and psychosocial variables.~   "
209381|NCT00820300|"~     The purpose of this study is to determine if the Punctal Plug Delivery System is safe and~     effective in controlling intraocular pressure in patients with ocular hypertension or~     open-angle glaucoma.~   "
209382|NCT00820287|"~     Testis cancer with germ cells is the most frequent cancer of young men and its incidence is~     in constant increase in many industrialized countries, as in France. An increased risk of~     developing testis cancer has been described in patients with testicular ectopia history and~     testicular cancer history (controlateral testicular cancer) and more recently suggested in a~     population of hypofertile men with altered spermatogenesis. To a better understanding of this~     risk, an attempt of characterization of this group of patients has been proposed in the~     present work.~      The general objective of this project is to characterize morphological and molecular markers~     of hypofertility which could serve as predictive markers of testis malignant transformation.~      In this project conducted in 3 establishments, the investigators propose:~        -  To select a population of hypofertile patients exhibiting compatible clinical and~          morphological characters with a high risk of testis tumoral transformation (secretory~          azoospermia and/or a history of testicular ectopia. To determine the spermatogenic~          arrests on histological criteria (score of Jonhsen).~        -  To study the expression of four proteins or family of proteins suspected of being~          involved in testis tumorogenesis such as: the Placenta Alkaline Phosphatase (PLAPE),~          cyclin A1, VASA and connexin (Cx) by immunohistochemistry and by real-time quantitative~          RT-PCR analysis real-time analyses.~        -  To establish a possible correlation between the clinical data, spermatogenesis arrest~          and the expression of these biomarkers.~      These approaches would allow to identify, in this population of hypofertile patients,~     subgroups of men who could develop tumours with germ cells, and subsequently to propose~     potential biomarkers for testis cancer. A more clinical observation of these subgroups will~     be also proposed.~   "
220834|NCT00668226|"~     The purpose of this study is to prove the absence of photo irritation and photo sensitivity~     potential of the product Dermacyd Delicata Pocket BR.~   "
209383|NCT00820274|"~     To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment~     of resistant vascular ulcers.~      To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement~     of quality of life.~      To evaluate rate of amputations and recurrence at one year after complete cicatrisation~   "
209384|NCT00820261|"~     Rotavirus is the most common cause of severe infantile diarrhoea disease in infants and young~     children below five years worldwide. It is associated with high cases of morbidity and~     mortality and it is estimated that up to 600,000 deaths in young children occur annually in~     the less developed countries and approximately 150,000-200,000 deaths occur in Africa alone.~     In Kenya, most rotavirus surveillance work has been done in Nairobi (an urban setting). Other~     parts e.g eastern Kenya, limited data is available and hence the prevalence and burden of~     rotavirus disease is under-estimated. We therefore hypothesize that rotavirus prevalence is~     high in Meru,Maua (a rural setting)and hence we designed a study to evaluate this.~      This is a prospective study to determine, the rotavirus disease burden and epidemiology in~     infants and children with severe diarrhoea hospitalized in three sentinel hospital in the~     eastern part of Kenya (Maua Methodist hospital) will be carried out during the period January~     2009 to December 2010.~      Faecal samples will be collected from infants and children admitted with acute diarrhoea and~     screened first for the presence of human serotype A rotavirus antigen using commercially~     available enzyme linked immunosorbent assay kit (ELISA).~      The positive samples will be evaluated by sodium dodecyl polyacrylamide gel electrophoresis~     (SDS-PAGE) to determine the electropherotypes and genotyped using reverse transcriptase~     polymerase chain reaction (RT-PCR) on VP7 and VP4 gene.~      These data/ results generated from this project will add crucial information on the rotavirus~     strains circulating in the eastern part of Kenya.~   "
209385|NCT00820248|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy in higher doses over a shorter period of time may kill more tumor cells and have~     fewer side effects. Drugs used in chemotherapy, such as cisplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. It is not yet known whether giving~     standard radiation therapy together with high-dose cisplatin is more effective than giving~     higher-dose radiation therapy together with panitumumab in treating patients with locally~     advanced head and neck cancer.~      PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see~     how well they work when given together with cisplatin or panitumumab in treating patients~     with locally advanced stage III or stage IV head and neck cancer.~   "
209386|NCT00820235|"~     The primary objective is to compare the gum response to three different dental implant~     designs when placed in the front region of the upper jaw. The changes from baseline to one~     year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes~     from baseline to one year after are equal for all three implant-abutment interface settings.~   "
209387|NCT00820222|"~     This open label study is designed to evaluate Lapatinib effect on incidence of brain~     metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior~     taxanes or anthracyclines.~   "
209388|NCT00820196|"~     Venous leg ulcers are a common, costly and debilitating condition, with few effective~     treatments. Compression bandaging helps healing, but more than four out of every ten leg~     ulcers remain unhealed after three months. New treatments to help heal venous ulcers are~     urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed~     by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a~     wound. Further research will be undertaken to assess the safety and activity of Nexagon® when~     applied to venous leg ulcers in humans, and to obtain further information on the most~     appropriate dose or doses to apply. A proposed randomised controlled trial aims to further~     evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous~     leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no~     medication) to be applied to their ulcer three times over four weeks. Participants will be~     followed up for 12 weeks to evaluate ulcer healing.~   "
209389|NCT00820183|"~     The study hypothesis is that the implementation of a plan for quality improvement at the~     primary care health teams taking care of hypertensive patients, will increase the level of~     blood pressure control among those patients.~   "
209390|NCT00820170|"~     The purpose of this study is to find the highest dose of dasatinib that can be safely given~     to a patient when the drug is given in combination with the known anticancer drug paclitaxel.~     Paclitaxel is an established anti-cancer drug, used in the treatment of many cancers, and it~     is an approved treatment for breast cancer. Dasatinib has been approved by the Food and Drug~     Administration for use as a single therapy in another kind of cancer, but its use in breast~     cancer patients, and in combination with paclitaxel is investigational.~      In this study, we will test the safety of dasatinib when given at different dose levels in~     combination with paclitaxel. We want to find out what effects, good and/or bad, it has on the~     patient and on metastatic breast cancer.~   "
209391|NCT00820157|"~     The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed~     by Transarterial Chemoembolization (TACE) with TACE alone in patients with MNHCC so as to~     establish a treatment standard for MNHCC.~   "
209392|NCT00820144|"~     It is a biomedical research without direct individual benefit, exploring and comparing the~     mucosal immune response after oral, nasal and sublingual administration of B-subunit of~     non-toxic cholera toxin (CTB) in healthy adult volunteers.~   "
209406|NCT00819936|"~     Summary Question: Does backward walking offer additional therapeutic value in patients after~     aortic aneurysm surgery? Participants: The study of backward walking as an addictive~     physiotherapy procedure was conducted in the group of 65 patients who underwent abdominal~     aorta surgery. The patients were randomly divided into three subgroups and three various~     models of physiotherapy were applied. Control group has only routine physiotherapy since~     therapeutic group I and II have also walking exercises forward in group I and backward in~     group II respectively.~   "
209407|NCT00819923|"~     The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (BAS)~     and everolimus-eluting stent (EES) in patients presenting with acute coronary syndrome.~   "
209393|NCT00820131|"~     Chronic pain after inguinal hernia repair has become a major concern. Although tension-free~     Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40~     % of patients complain of some kind of pain even one year after surgery. The necessity of~     mesh-fixation using sutures, could be causative. However, current data do not provide~     evidence whether suture fixation in Lichtenstein repair might be the reason for chronic~     postoperative pain.~      A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal~     hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid~     gripping system. Thereby the rate of chronic postoperative pain could be decreased.~      Two techniques of inguinal hernia repair will be evaluated:~        1. open anterior mesh repair using conventional Lichtenstein technique (sutures for~          mesh-fixation)~        2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for~          mesh fixation)~      Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at~     the 10th day, as well as 3 and 15 months postoperatively.~   "
209394|NCT00820118|"~     The primary objective of the trial is to assess the ability of an early and intermittent~     antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV~     infected adults, to offer a potential alternative strategy to differed and continuous~     antiretroviral treatment.This is a 2-year phase II, open-label, multicentric proof of~     concept trial. The patients included are treated following a pulse-therapy scheme, i.e.~     6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods~     without antiretroviral therapy. The preferentially recommended treatment of the study is~     atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and~     lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the~     efficacy and the tolerance of the strategy, with clinical, biochemical, immunological,~     virological and pharmacokinetic evaluations.~   "
209395|NCT00820105|"~     Evaluation of ADX10059 to prevent migraine attacks~   "
209396|NCT00820092|"~     1. To investigate the safety and tolerability of Xerecept during and following a 24-hour~          intravenous administration to healthy Japanese to healthy Japanese and Caucasian~          subjects~        2. To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept~          administration between healthy Japanese and Caucasian subjects~   "
209397|NCT00820079|"~     Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal~     reflux.~   "
209398|NCT00820053|"~     The aim of this study is to analyze the therapeutic effect of adjuvant TACE after~     resection.Patients receiving curative resection (R0) were randomized to postoperative TACE~     group and no TACE group. The time to recurrence ,the overall survival as well as the~     incidence of complications after therapy was observed to confirm the role of adjuvant TACE.~   "
209399|NCT00820027|"~     The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to~     placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total~     knee replacement surgery.~   "
209400|NCT00820014|"~     The purpose of this study is to determine whether ESBA105, a single-chain (scFv) antibody~     against TNF-alpha, efficiently penetrates into the anterior chamber and the vitreous body~     upon topical administration to the eye.~   "
209401|NCT00820001|"~     This continuation study evaluates the long-term outcomes of multimodal, modular interventions~     with early-onset behavior disordered children and innovative methods to promote the~     maintenance and extension of treatment effects relating to ODD and CD. All participants~     originally enrolled in the parent clinical trial are being followed and those who initially~     received clinic or community based intervention from a study clinician were randomly assigned~     to either Booster or No-booster treatment condition. The treatment-as-usual (TAU) and Healthy~     Control participants were also followed through long-term follow-up assessments paralleling~     clinically referred participants. The study examines the short and long-term efficacy of~     booster treatment on clinical outcome, contextual variables, and service satisfaction/use.~   "
209402|NCT00819988|"~     The purpose of this study is to determine whether administration of pregabalin by mouth~     immediately preoperatively and three times daily for 3 days after surgery reduces the~     incidence of delirium postoperatively and improves overall pain control.~   "
209403|NCT00819975|"~     Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular~     risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates~     profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little~     information exists about the effect of proteins.~      The purpose of this study is to compare the effects of the milk proteins casein, Whey~     Isolate, Whey Hydrolysate, and Alphalact-Albumin on postprandial lipid and incretin responses~     to a high-fat meal in type 2 diabetes.~   "
209404|NCT00819962|"~     Perioperative analgesia using US guided TAP block~   "
209405|NCT00819949|"~     Freezing of gait (FOG) is a common yet poorly understood motor symptom in persons with~     Parkinson's disease (PD). Previous studies have shown that bilateral uncoordinated gait and~     gait asymmetry are related to FOG, and that intensive treadmill training in PD patients can~     improve gait. However, no group has yet studied the effect of robot-assisted gait training~     (RAGT) on FOG. The primary aim of this study is to collect pilot data on the effect of~     robot-assisted gait training in reducing episodes of freezing in PD.~      Subjects with Parkinson's disease that experience freezing of gait will be recruited and~     enrolled following informed consent and screening for eligibility. Each of the 10 training~     session will last approximately one hour. Neurological evaluations, testing of gait~     parameters, and quality of life assessments will be conducted. Participants will also be~     asked to return for 1- and 3-month post-intervention assessments to see if the training has~     any lasting effects. Approximately 10-20 subjects will be enrolled, and the study will last~     up to 6 months.~      Robot-assisted gait training will be conducted with the Lokomat (a treadmill with~     supplemental robot-assistance for moving the hip and knee). We will monitor changes in~     freezing by conducting various assessments.~      There are approximately 1 million Americans with PD in the US. PD is a significant cause for~     reduced functional ability and quality of life, progressive disability. Patients with PD with~     FOG have indicated that this is one of their most disturbing symptoms, as there are no~     effective treatments. Therefore it is important that additional and alternative interventions~     for FOG be tested and developed.~   "
228912|NCT00560729|"~     Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional~     supplementation in elderly patients~   "
209408|NCT00819910|"~     The design of the study will be randomized, double blind trial, which will examine the~     effects of Rosiglitazone on the fasting triglycerides (TG), high-density lipoprotein (HDL),~     low-density lipoprotein (LDL), and plasma concentrations of apolipoproteins A-I, A-II, and~     C-III as compared to Fenofibrate and placebo. This study will also assess the synergistic~     effect of Rosiglitazone and Fenofibrate on the same parameters. Data from this study will~     help clarify whether Rosiglitazone favorably impacts plasma lipid and lipoprotein~     concentrations through improving insulin sensitivity and glycemic control, or by directly~     influencing the synthesis of the apolipoproteins that are responsible for very-low-density~     lipoprotein (VLDL) and HDL metabolism.~   "
209409|NCT00819897|"~     The aim of this study is to evaluate the role of cognitive disorders and quality of life in~     patients with CIS, considered as high risk to develop an MS, treated with interferon Beta.~     This prospective observational study will include 120 patients, all treated and evaluated~     annually with neurological extensive examination, ophthalmologic screening (OCT, OF, VEP,~     VF), auto questionnaire about fatigue (musicol, ELIF), quality of life (SEP-59), and~     conventional MRI.~   "
209410|NCT00819884|"~     The purpose of this study is to compare the 24-hour glucose profiles in diabetic patients~     treated with metformin following once daily and twice daily oral dosing~   "
209411|NCT00819871|"~     NFKB1 -94ins/del polymorphism has been reported to be associated with reduced promoter~     activity of NFKB1 and several clinical diseases, but the clinical results cannot always be~     replicated. Besides, mutate allele is associated with alleviated inflammation in ulcerative~     colitis and some tumors, but aggravated inflammation in ARDS. The clinical value of this~     polymorphism remains controversial. This study was performed to investigate the association~     of NFKB1 -94ins/delATTG polymorphism with lung and/or kidney injury after cardiac surgery~     with CPB.~   "
209412|NCT00819858|"~     The primary objective of this study is to determine to what extent provision with RUTF will~     promote catch up growth in children following an acute uncomplicated episode of P. falciparum~     malaria.~   "
209413|NCT00819845|"~     Data on preventive therapy in Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy~     (BMD) affected individuals without cardiac involvement are very limited and currently lacking~     regard both ACE-inhibitors and Beta-Blockers in Becker Muscular Dystrophy and for the latter~     even in Duchenne Muscular Dystrophy patients. Thus, the study aim is to compare the efficacy~     of carvedilol vs ramipril on myocardial tissue properties and heart function, performing CMR~     and myocardial Ultrasound Tissue Characterisation analysis.~   "
209414|NCT00819832|"~     Phase 1 - Optimization Phase:~      Primary Objective: The primary objective of Phase 1 of this study is to determine the time~     point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard~     vertebroplasty and Kyphoplasty procedures relative to baseline CTCB.~      Phase 2 - Comparison Phase:~      Primary Objective: The primary objective of Phase 2 of this study is to determine the change~     in CTCB from baseline to post-treatment as measured using the CellSearch™ Assay and to~     compare the average change between treatment groups with and without the use of the Cavity~     SpineWand.~      Secondary Objectives:~        -  To determine the change in self-reported pain level from baseline to post-treatment as~          measured using the visual analogue scale (VAS) for spine pain and to compare the average~          change in pain level between treatment groups.~        -  To determine the change in pain status from baseline to post-treatment as measured using~          the Brief Pain Inventory (BPI) and to compare the average change in pain status between~          treatment groups.~        -  To determine the change from baseline to post-treatment in the M.D. Anderson Cancer~          Center Symptom Inventory (MDASI) and to compare the average change between treatment~          groups.~        -  To determine the change from baseline to post-treatment in time to walk a 50-foot~          distance and to compare the average change between treatment groups.~   "
209415|NCT00819819|"~     The study will identify a cohort of infants at risk for celiac disease that can be followed~     on a long term basis for investigating the natural history the celiac disease based on the~     pattern of early nutrition. The study will investigate possible early feeding patterns~     including the timing of introduction to gluten that may protect at least in part from CD~     development in at risk infants.~   "
209416|NCT00819806|"~     Subjects will receive immunizations every other week for 8 immunizations prior to clinical~     and immunological evaluations. Patients will then receive immunizations every month up to one~     year. Cyclophosphamide will be administered intravenously 3 days prior to the first~     immunization, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations. Women and men >= 18~     years of age with refractory metastatic malignancies that express NY-ESO-1 by RT-PCR or~     immunohistochemistry. Alternatively, patients may be elected on the basis of serum~     anti-NY-ESO-!-antibodies as detected by ELISA.~      Primary Objective: To evaluate the toxicity profile of the regimens described in Section 1.6.~      Secondary Objective: To detect and quantitate immune responses induced by the proposed~     peptide vaccine or protein vaccine in association with CpG 7909 and cyclophosphamide. This~     endpoint will be assessed by an IFN-y ELISPOT assay of NY-ESO-1-specific tumor-reactive CD8 +~     T cells. We also will look for NY-ESO-1 tetramer CD8+ T cells, Delayed-type Hypersensitivity~     (DTH), and NY-ESO-1-specific CD4+ T cell responses with ELISPOT assays and~     cytokine-release-assays.~      Tertiary Objectives: To evaluate tumor response in terms of clinical tumor regression and~     progression-free interval. To evaluate the survival of patients treated with the regimens~     described in Section 1.6.~      The first 3 patients will be assigned treatment A. All three patients will be treated and~     observed for one month. If no DLTs are observed in the first 3 patients, accrual to arm A~     will be put on hold and accrual will continue with Arm B. However, if 1 DLT is observed in~     Arm A, up to 3 additional patients will be treated on Arm A, until either 2 DLTs have been~     observed, or 6 patients have been treated with just 1 DLT among them. If 2 DLTs are observed~     in Arm A, the study will terminate and all treatments will be deemed intolerable. The same~     principles apply to the cohorts treated on B-E: if the number of DLTs (after one month of~     treatment) is zero, accrual proceeds to the next treatment group; if it is 1, accrual~     continues with the same treatment for up to 3 additional patients; if it is 2, no patients~     will be treated on the remaining treatment arms.~   "
209417|NCT00819793|"~     The purpose of the study is to evaluate the safety and effectiveness of the CentriMag~     ventricular assist system to help patients who have experienced heart failure during surgery~     and cannot be removed from cardiac bypass.~   "
209418|NCT00819780|"~     The primary objective of this study is to estimate the treatment effect on progression-free~     survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6~     chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS,~     unresectable mCRC.~   "
209419|NCT00819767|"~     This study compared the blunting effect of aliskiren and valsartan monotherapies on~     exercise-induced rises in systolic blood pressure in patients with mild to moderate essential~     hypertension.~   "
209470|NCT00819078|"~     Bupropion has been used successfully and safely for smoking cessation in adults. It was also~     used in very few studies among adolescent population. Our hypothesis is that Bupropion would~     be effective and safe among the adoelscent psychiatric population. A double-blind randomized~     controlled-trial will be held to determine that.~   "
209420|NCT00819754|"~     Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are~     associated with high response rates and long survival as first-line treatment for metastatic~     colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and~     shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I~     dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD)~     and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This~     phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose~     (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD~     in an expanded cohort.~   "
209421|NCT00819741|"~     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood~     sugar lowering effect of repaglinide plus metformin as initial treatment compared to~     repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated~     haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The~     associated unfavourable events including low blood sugar episodes between the two treatments~     are also compared.~   "
209422|NCT00819728|"~     The main purpose of the study is to determine the activity of the weekly combination of~     docetaxel (Taxotere) and irinotecan in terms of response rate in subjects with advanced,~     previously untreated, non-small cell lung cancer. It is also to determine the activity of~     this combination in terms of response duration, time to progression, median survival, overall~     survival, and percent one-year survival, as well as the side-effect and toxicity profile of~     weekly Taxotere and weekly irinotecan.~   "
209423|NCT00819715|"~     The purpose of this study is to determine whether small for gestational preterm infants, have~     delayed or decrease gastric motility compared to appropriate for gestational age preterm~     infants.~   "
209424|NCT00819702|"~     Our broad goal is to help prevent child maltreatment (CM) by modifying pediatric practice to~     be more responsive to prevalent psychosocial needs of many children and families.Training~     pediatricians to address key risk factors for CM, the Safe Environment for Every Kid (SEEK)~     model aims to support parenting and family functioning, reducing the risk for CM while~     helping promote children's health, development and safety. We are building upon the existing~     pediatric primary care system and strengthening the training of pediatricians. The project~     also builds on our extensive research and clinical expertise in CM and in prevention (Black &~     Dubowitz, 1999, Dubowitz et al., 1998, 1999, in press; Dubowitz & Guterman, 2005, Gaudin &~     Dubowitz, 1997).~      We have developed and implemented an enhanced model of pediatric primary care, taking~     advantage of the enormous opportunities of the existing pediatric primary care system, with~     its regular contact with young children and parents (Dubowitz & Newberger, 1989; Dubowitz,~     1989, 1990; Green, 1994). Pediatricians typically devote over half their time to checkups,~     focusing on prevention. There is increasing recognition that pediatric care must incorporate~     aspects of parental and family functioning and collaborate with community resources (Academy~     of Pediatrics, 1998; Green, 1994b). The broad goal of this project is to implement concepts~     that have been embraced by the field of pediatrics, but have not been applied and tested.~   "
209425|NCT00819676|"~     The aim of this study is to investigate the pattern of organic volatile compounds (VOCs) in~     the exhaled breath detected by biosensors in adults with persistent mild asthma. The analysis~     of VOCs detected by biosensors in asthmatic adults will be compared with that in a control~     group of healthy subjects and with exhaled nitric oxide (NO).~      Identification of breath VOC patterns may be a completely noninvasive new technique for~     assessing airway inflammation. A device containing a series of nanosensors can be used for~     breath analysis of VOC patterns through integration with a suitable algorithm for pattern~     recognition.~      Preliminary data indicate that exhaled breath patterns detected by biosensors in healthy~     subjects are different from those in patients with asthma. In patients with asthma, analysis~     of exhaled breath using biosensors will be compared with exhaled NO measurement for studying~     a possible correlation with an independent method for assessing airway inflammation and with~     spirometry for assessing a possible correlation with lung function.~      Measurement of exhaled NO is a well-established, validated, and standardized method for~     assessing and monitoring of airway inflammation in patients with asthma who are~     steroid-naive. In patients with asthma, exhaled NO concentrations are correlated with blood~     eosinophil cell counts and with airway hyperresponsiveness (AHR).~      This study could contribute to the identification and development of a completely new~     non-invasive technique for assessing airway inflammation with important implications for~     diagnosis and therapeutic monitoring of patients with asthma.~      Establishing the effect of anti-inflammatory drugs on breath analysis by biosensors in~     patients with asthma is relevant for future studies aimed to use this technique in asthma~     management.~   "
209426|NCT00819663|"~     Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response~     and can be detected in patients undergoing serial computed tomography enterography (CTE).~   "
209427|NCT00819650|"~     The aim of this study is to analyze the therapeutic effect of adjuvant Licartin therapy after~     resection.Patients receiving curative resection (R0) were randomized to postoperative~     Licartin group and no Licartin group. The time to recurrence ,the overall survival as well as~     the incidence of complications after therapy was observed to confirm the role of adjuvant~     therapy of Licartin.~   "
209428|NCT00819637|"~     The purpose of this study is to determine the best dose of nebulized arformoterol, a quick~     onset but long acting beta agonist, for use in treating acute bronchospasm in asthmatics~     presenting to the the Emergency Department. Also this study will evaluate the side effect and~     safety profile of arformoterol when used in this situation.~   "
209429|NCT00819624|"~     The study has two goals. The first goal of the study is to compare two methods of~     administering questions about pain and sleep interference. The two methods being compared are~     a telephone based system and an electronic hand held diary. The second goal of the study is~     to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.~   "
209430|NCT00819611|"~     The purpose of this study is to investigate whether working memory training improves~     behavioral symptoms, neurocognitive performance, and neural functioning in young children~     with ADHD.~   "
209471|NCT00819065|"~     The purpose of this study is to compare the effectiveness between two commercial formulations~     of botulinum toxin type A in the treatment of spasticity through the Ashworth scale.~   "
209431|NCT00819598|"~     Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD~     are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is~     the ratio of ankle pressure to arm pressure based on measurement of blood pressures in the~     arms and legs using a Doppler device. The need for dedicated equipment and trained personnel,~     along with the time required to perform the test, have been identified as barriers to~     widespread implementation of ankle-brachial index screening. The use of automated~     oscillometric devices for blood pressure measurement and determination of the ankle-brachial~     index has been applied with variable success. It will be beneficial to investigate a reliable~     oscillometric-based procedure that can accurately measure leg pressures for the~     ankle-brachial index across the entire spectrum of PAD severity.~      The purpose of this study is to determine the optimal oscillometric-based technique for~     estimation of Doppler-derived systolic arm and ankle blood pressures for calculation of the~     ankle-brachial index in patients with and without PAD.~      Subjects with suspected arterial disease in the non-invasive lab will be enrolled. Arm,~     ankle, and toe pressure measurements will be made in the supine position using Doppler,~     oscillometric methods, and photoplethysmographic sensor. Arm and ankle pressures from a~     subset of subjects will be obtained in both seated and supine positions. The ankle-brachial~     index and toe-brachial index will be calculated.~   "
209432|NCT00819585|"~     A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to~     evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in~     chronic gout patients initiating allopurinol therapy~   "
209433|NCT00819572|"~     The purpose of this study is to determine whether an intra-articular injection of DLX105 to~     the knee joint of patients suffering from severly painful osteoarthritis is safe and reduces~     pain.~   "
209434|NCT00819559|"~     Hypothesis~        -  Pre operative radio-chemotherapy might be not mandatory to improve local recurrent rate~          and survival rate in the mid-lower rectal cancer patients with T3N0 clinical stage, if~          surgical principals were kept.~        -  Laparoscopic resection is not inferior to Open surgery in the treatment of rectal~          cancer.~   "
209435|NCT00819546|"~     The purpose of this research study is to determine the safety of the combination of RAD001~     and PKC412 as a cancer treatment, and to establish the highest dose of RAD001 that can be~     given in conjunction with PKC412. These drugs have been used in other research trials for~     individuals with solid and hematology malignancies. Past research on PKC412 shows that it~     blocks the abnormal functioning of an enzyme called FLT3. FLT3 is found in your cells in~     either a normal (wild type) or genetically changed form and plays a role in the survival and~     growth of AML cells. RAD001 is an inhibitor of a central growth pathway that involves the~     protein MTOR. The MTOR pathway is overactive in cancer cells, causing the cells to grow~     abnormally. By inhibiting the abnormal growth activity of the MTOR pathway, RAD001 slows down~     and possibly stops the growth of cancer cells.~   "
209436|NCT00819533|"~     This study is designed to evaluate preliminary safety and accuracy of the ActiSight™ Needle~     Guidance System in patients undergoing CT-guided lung aspiration or biopsy. This image~     guidance system uses a combination of CT scans and camera images to help guide a biopsy~     needle to a lung lesion. The system displays a simulated image of a biopsy needle and its~     estimated path for the biopsy.~   "
209437|NCT00819520|"~     The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single~     applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who~     have recently used standard head lice treatments without success.~   "
209438|NCT00819507|"~     The purpose of this study is to determine the effect of short-term therapy using VANOS~     Cream, a super-potent topical steroid cream on skin barrier function in patients with atopic~     dermatitis. This cream is already approved for this indication, but the investigators will~     further examine its effects on the skin barrier. This cream is a novel formulation of~     fluocinonide designed to enhance compliance with a cream base, but have the skin barrier~     repair properties of an ointment.~   "
209439|NCT00819494|"~     The purpose of this trial is to study the diagnostic role of skin test in immediate reactions~     to iodinated radiocontrast media.~   "
209440|NCT00819481|"~     The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total~     knee replacement surgery.~   "
209441|NCT00819468|"~     This is a study to compare the pharmacokinetic profile of teduglutide in healthy subjects~     with normal hepatic function with subjects who have moderate hepatic impairment.~   "
209442|NCT00819455|"~     Type 2 diabetes is a major and increasing problem in India and the UK. In clinical trials it~     can be prevented in people at high risk by lifestyle intervention. While these trials~     established the proof of principle, they involved a degree of input from healthcare~     professionals not feasible outside the trial situation. We hypothesize that diabetes~     prevention can be achieved at lower cost using personalised feedback via mobile phone, based~     on information on healthy diet and physical activity habits. We shall develop research~     protocols and computerized algorithms to test this hypothesis in India for application~     subsequently in the UK and elsewhere.~   "
209443|NCT00819442|"~     The purpose of this study is evaluation of expression of desmin in cardiomyocytes of patients~     with idiopathic dilated cardiomyopathy. Analysis of relationship between desmin expression~     and activities of mitochondrium and expression of ubiquitin.~   "
209444|NCT00819429|"~     This is a 36-week, randomised, double-blind, placebo-controlled trial. The overarching aim of~     this study is to assess whether a nutritional intervention (Omega-3 supplement), when~     combined with a more traditional treatment approach to conduct disorder and Attention Deficit~     Hyperactivity Disorder (ADHD), is more effective than either approach alone in treating these~     conditions in children and adolescents. The research questions cannot be answered through~     alternative means because disruptive behaviour disorders are primarily childhood disorders.~   "
209458|NCT00819247|"~     The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of~     patients were treated for six months on different doses. The patients had blood samples taken~     and measured for Testosterone in order to determine the most efficient dose to provide fast~     and sustained castration. The patients came to the clinic for 16 visits and dependent on the~     blood sample results they were invited to return for additional blood samples on a two weekly~     basis.~   "
228913|NCT00560716|"~     This is a phase I study of an investigational cancer drug, CYC116, in patients with advanced~     solid tumors.~   "
209445|NCT00819416|"~     Severe infection in the intensive care unit is common accounting for about 10% of admissions~     and has a death rate of approximately 40-50%. It is almost always associated with significant~     reductions in blood pressure. Administration of fluid often in large volumes is essential to~     normalize blood pressure and prevent failure of organs and death. Two common classes of fluid~     solutions are crystalloid fluids (salt based, normal saline) and colloid fluids (protein~     based, albumin). Due to its properties, the albumin fluid may remain in the vascular space~     better than the normal saline solution. Hence, there may be faster attainment of normal blood~     pressure as well as a reduction in failed organs and death. Preliminary clinical trial data~     suggests a potential for benefit with albumin in this setting but these findings require~     confirmation in a large clinical trial.~      There are few data to explain how albumin may exert its protective effects and lead to better~     outcomes for patients with severe infections. We will conduct a clinical study that will~     examine potential biological mechanisms for albumin's protective effects in 50 patients~     across 6 Canadian academic hospitals. We will also examine our ability to successfully~     recruit patients into this trial.~      This study will provide information that will help to understand the biological mechanisms of~     albumin in severe infection. The information gained will guide the investigative team for~     future fluid related mechanistic questions. The study will also provide essential information~     that will aid in the design and conduct of the future large clinical trial that will examine~     death as its primary outcome.~   "
209446|NCT00819403|"~     To determine whether the combination of ezetimibe and simvastatin improves biomarkers of~     atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.~   "
209447|NCT00819390|"~     HIV is characterized by frequent immune system activation. Early in the course of infection~     the body establishes an immune activation set point related to the amount of HIV in the~     blood stream. This set point affects the rate of CD4 cell loss. Without CD4 cells, or with~     very low levels of CD4 cells, the body cannot fight off illness. This is known as~     immunodeficiency. If left untreated HIV can lead to extreme immunodeficiency and AIDS.~      Evidence suggests that by decreasing the rate of immune system activation, immune deficiency~     progression could be prevented. The purpose of this study is to learn how well chloroquine~     can reduce the level of immune activation and to test the safety and tolerance of chloroquine~     in people infected with HIV.~   "
209448|NCT00819377|"~     Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac~     surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of~     being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the~     pulmonary artery.~   "
209449|NCT00819364|"~     This is a randomized controlled study to determine whether the BCRI~     (Behavior－Cognition－Relationship Intervention) model is effective for the autistic children.~     BCRI model is a eclectic method using behavior modification, structure teaching,~     relationship-focus approaches according to the symptom severity and main problems at any~     stage of training for the autistic children. The BCRI Model emphasis the importance that~     parents understand the principle of training and education and can use them skillfully,~     appropriately and persistently.~   "
209450|NCT00819351|"~     The purpose of this study is to investigate if intramuscular PEG-asparaginase administered~     either at six or two week intervals from day 92 until 8 months from diagnosis for patients~     with non-HR ALL will result in equal probability of Event Free Survival~   "
209451|NCT00819338|"~     The principal purpose of this study is to determine whether increased intakes of n-3~     polyunsaturated (omega-3) fatty acids will reduce the amount of fat stored in the liver in~     patients with non-alcoholic fatty liver disease.~   "
209452|NCT00819325|"~     Patients with diabetes have worse outcomes after percutaneous coronary intervention (PCI)~     procedures, compared to those patients without diabetes. They are at increased risk of death,~     heart attack, or needing further procedures due to renarrowing of their coronary narrowings~     after implantation of a coronary stent. Studies have suggested that poor control of diabetes~     may be partly responsible for these poor outcomes. Thiazolidinedione drugs, such as~     pioglitazone, can improve the diabetes control and make the patient more sensitive to the~     effects of insulin. Preliminary studies suggest that pioglitazone may also help prevent~     renarrowing after PCI.~      This study was a pilot study designed to determine whether more aggressive treatment of the~     diabetes with the routine use of the drug pioglitazone (30mg/day for 6 months), in addition~     to the patient's usual diabetic medications adjusted to optimize their diabetic control (get~     glycated hemoglobin < 7%), could reduce the amount of tissue buildup within the stent after 6~     months, compared to a group less aggressively treated without pioglitazone and their usual~     medications for diabetes.~      An intravascular ultrasound probe was used to assess the extent of tissue buildup within the~     stent and this was performed immediately after the PCI as a baseline and repeated after 6~     months of therapy.~      The investigators hypothesize that the more aggressive diabetic treatment with pioglitazone~     would reduce the extent of tissue growth within the stent after 6 months of therapy.~   "
209453|NCT00819312|"~     The purpose of this study is to evaluate the effectiveness in terms of prevention of~     pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.~   "
209454|NCT00819299|"~     The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will~     provide an effective method for the correction of presbyopia in patients who have normal~     distance vision but need a correction such as glasses or contact lenses to see clearly at~     near.~   "
209455|NCT00819286|"~     The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to~     normal activity in open heart surgery patients who had their breast bone closed either with~     wires or plates.~   "
209456|NCT00819273|"~     An observational, non-interventional, multi-centre study to provide further information on~     the utility of test for a predictive marker by investigating the current prevalence of high~     sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.~   "
209457|NCT00819260|"~     Purpose: The aims of this randomized clinical trial are to assess and compare 3 different~     outcomes in women undergoing breast reduction surgery using two different surgical devices:~     the Harmonic Scalpel and electrocautery.~      The three metrics are:~        1. the time taken to complete the operation~        2. drainage volume in the days immediately following surgery,~        3. patient pain in the days immediately following surgery.~   "
209459|NCT00819234|"~     Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with~     randomized study medication. The purpose of the extension study is to examine the long-term~     (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide~     and metreleptin, administered as separate subcutaneous (SC) injections, in obese and~     overweight subjects.~   "
209460|NCT00819221|"~     The study will be an open label, multicenter, dose finding study. Depending on the tolerated~     dose up to 7 dose levels will be explored in this study, approximately 33 patients (21-54~     depending on number of cohorts) may be enrolled into this study. Three patients will be~     initially dosed in each cohort. The primary objective of this study is to determine the~     recommended dose (RD) of twice daily oral doses of AZD2281 either as intermittent therapy for~     7 days out of a 28-day schedule or given continuously, administered in combination with~     liposomal doxorubicin to patients with advanced solid tumors.~   "
209461|NCT00819208|"~     RATIONALE: Participating in a physical activity program designed to increase free time~     physical activity and receiving written health education materials may influence the chance~     of cancer recurring as well as impact on physical fitness, psychological well-being and the~     quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It~     is not yet known whether giving a physical activity program together with health education~     materials is more effective than giving health education materials alone for patients who~     have undergone colon cancer treatment.~      PURPOSE: This randomized phase III trial is studying a physical activity program given~     together with health education materials to see how well it works compared with giving health~     education materials alone for patients who have undergone treatment for high-risk stage II or~     stage III colon cancer.~   "
209462|NCT00819195|"~     The purpose of this study is to determine whether glatiramer acetate (Copaxone) will induce~     anti-inflammatory type II monocyte development during treatment of MS, and if these antigen~     presenting cells (APC) will promote Th2 and Treg differentiation of naïve T cells.~   "
209463|NCT00819182|"~     Background: Paced respiration has been internationally recommended for vasomotor symptom~     management despite limited empirical evidence.~      Objective: To evaluate efficacy of a paced respiration intervention against a sham comparator~     breathing control and usual care control for vasomotor and other menopausal symptoms.~      Design: A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and~     stratification by group (breast cancer, no cancer), Midwestern city and surrounding area.~      Participants: 218 randomized women (96 breast cancer survivors, 122 menopausal women without~     cancer) recruited through community mailings and registries.~      Interventions: Training, home practice support, and instructions to use the breathing at the~     time of each hot flash were delivered via compact disc with printed booklet (paced~     respiration intervention) or digital videodisc with printed booklet (fast shallow breathing~     control). Usual care control received a letter regarding group assignment.~      Main Measures: Hot flash frequency, severity, and bother (primary), hot flash interference in~     daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary).~     Intervention performance, adherence, and adverse events were assessed.~   "
209464|NCT00819169|"~     This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be~     conducted in the United States and Spain.~      Part 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG 479~     that is safe and tolerable.~      Part 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected in~     Part 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC~     (non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, and~     sarcoma.~   "
209465|NCT00819156|"~     The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing~     six different doses. The patients participating in the trial were treated with degarelix~     every month for a year. During the treatment the patients had to visit the clinic for~     investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone,~     follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed~     throughout the trial.~   "
209466|NCT00819143|"~     Although allogeneic stem cell transplantation is curative in CML, evidence of the BCR-ABL~     oncogene at low levels is still found in long-term follow-up of survivors. Such low levels of~     BCR-ABL post-transplant which do not fulfill criteria for molecular relapse are monitored~     regularly and considered to be suppressed by the GVL effect. Treatment with donor lymphocyte~     infusions is only instituted when quantifiable BCR-ABL transcript levels rise steadily,~     indicative of a true molecular relapse .~      Similarly, BCR-ABL is still detectable in the majority of CML patients treated with imatinib~     who achieve complete cytogenetic response, although the amount of BCR-ABL transcripts seem to~     decline with longer follow-up. With 5 years follow-up of CML patients at CP who received~     imatinib, the estimated cumulative best rates of complete hematologic response and complete~     cytogenetic response were 98 percent and 87 percent, respectively10. For the minority of~     CP-CML patients who do not respond satisfactorily to imatinib, second-generation tyrosine~     kinase inhibitors are now the recommended next line of treatment.~      A major question facing clinicians is whether imatinib and the other more pharmacologically~     potent second-generation tyrosine kinase inhibitors;can suppress the CML clone at the~     leukemic stem cell level as effectively as allogeneic stem cell transplantation. This~     protocol is designed to scientifically compare the treatment responses of patients who are~     treated with allogeneic stem cell transplantation with patients who receive imatinib or~     second generation tyrosine kinase inhibitors.~      The primary endpoint of this trial will be the proportion of patients who have detected~     minimal residual disease (DMRD) in primitive CD34 plus progenitor subpopulations no earlier~     than 60 days from the onset of their respective treatments.~   "
209467|NCT00819117|"~     The purpose of this study is to demonstrate that epicardial and transvenous left ventricular~     leads are safe and effective for cardiac resynchronization therapy in heart failure patients~     implanted with a CRT device.~   "
209468|NCT00819104|"~     This is a randomised, open-label; parallel group, multicentric study comparing the efficacy~     and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual~     components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in~     lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female~     patients of essential hypertension aged between 18-80 years will be studied. The patients~     should not have a history of prior cardiovascular disease.~   "
209473|NCT00819039|"~     This two part study will determine the appropriate dosing regimen of aprepitant for the~     prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to~     17 years of age, by assessing pharmacokinetic parameters and monitoring safety and~     tolerability of administered doses. Part I will be an open label investigation of a single~     dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after~     aprepitant dosing. Part II will be a double blind trial of participants randomized to receive~     either aprepitant or ondansetron.~   "
209474|NCT00819026|"~     Hepatitis C Virus is constantly evolving genetically, particularly in response to the immune~     system. This is an observational study to examine if immunosuppressants particularly~     calcineurin inhibitors taken by transplant patients in order to avoid organ rejection causes~     predictable changes in the genetics of this virus that might be important in order to treat~     it effectively.~   "
209475|NCT00819013|"~     This multi-center study will be conducted in the United States with up to 80 healthy adult~     subjects. Subjects will be scheduled to receive a total of two (2) injections with 1~     injection each administered.~      Subjects will be randomized according to a randomization scheme.~   "
209476|NCT00819000|"~     The purpose of this study is to determine if higher compliance and adherence rates to drug~     therapy for MS result in better health outcomes than lower rates of therapy compliance and~     adherence.~   "
209477|NCT00818987|"~     To determine if operative treatment of non operative management of these fractures is best.~     Hypothesis: There is no difference in functional outcome between operative and~     non-operatively treated 3- and 4-part proximal humerus fractures at one year's time.~   "
209478|NCT00818961|"~     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop~     the growth of cancer cells. It may also stop the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune cells and help~     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving a~     monoclonal antibody, such as alemtuzumab, before transplant and tacrolimus and methotrexate~     after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying the side effects of donor stem cell transplant and~     to see how well it works in treating patients with high-risk hematologic cancer.~   "
209479|NCT00818948|"~     This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose~     escalation study, enrolling approximately 48 subjects. Part A of the study will enroll~     subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3~     cohorts. Part B of the study will enroll SLE subjects with GN into 3 cohorts. The purpose of~     the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and~     pharmacokinetics.~   "
209480|NCT00818935|"~     The purpose of this study is to determine whether low and intermediate GI Caribbean foods are~     effective in the management of type 2 diabetes.~   "
209481|NCT00818909|"~     To evaluate the physical effect of SYSTANE QID in people that have moderate to severe dry~     eyes and to establish doctor confidence to prescribe Systane.~   "
209482|NCT00818896|"~     There is general agreement that thyroid gland function should be assessed in pregnant women.~     When the gland produces too little thyroid hormone (hypothyroidism), all of the woman's~     bodily functions slow down, and there are problems with her baby's development. Until now,~     physicians have identified this problem on an individual basis (case-finding), but this~     approach misses many of the cases. Our trial aims to replace case-finding with a routine~     blood test that is highly effective at detecting hypothyroidism, thereby allowing treatment~     to correct the deficiency. This approach can eventually be implemented throughout the United~     States.~   "
209483|NCT00818883|"~     The purpose of this study is to compare the antihypertensive effect of chlorthalidone vs~     hydrochlorothiazide when each is used with azilsartan medoxomil, once daily (QD), in~     participants with moderate to severe essential hypertension.~   "
209484|NCT00818870|"~     The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and~     Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.~   "
209485|NCT00818857|"~     The purpose of this project is to improve cancer screening rates within practices serving~     low-income minority patients~   "
209486|NCT00818844|"~     The purpose of this study is to compare the macular volume of patients treated with a 3-month~     course of topical Nepafenac (0.1% solution) to patients treated with a placebo course~     following epiretinal membrane surgery.~   "
209487|NCT00818831|"~     The purposes of this trial are:~        -  To evaluate the toxicity and tolerability of QBI-139 in patients with advanced~          refractory solid tumors.~        -  To determine the maximum tolerated dose of QBI-139 in patients with advanced, refractory~          solid tumors.~      Patients will receive QBI-139 by IV infusion over at least one hour once weekly for three~     weeks. Treatment repeats every 21 days in the absence of disease progression or unacceptable~     toxicity.~      Cohorts of 3 to 6 patients receive escalating doses of QBI-139 until the maximum tolerated~     dose (MTD) is determined.~   "
209488|NCT00818818|"~     This study was designed to evaluate the effect of low doses of pentavalent antimony~     (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65~     years. The hypothesis is that older patients may have a positive response with a lower dose~     of pentavalent antimony, avoiding the frequent adverse events observed with the standard~     dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with~     the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The~     endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up~     after treatment to avoid the impact of spontaneous cure as a confounding factor.~   "
209489|NCT00818805|"~     To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal~     allergic conjunctivitis.~   "
209523|NCT00818363|"~     This is a research study testing SABER™-Bupivacaine (an experimental pain-relieving~     medication). SABER™-Bupivacaine is designed to continuously deliver bupivacaine, a common~     local anesthetic, for a few days in order to treat local post-surgical pain.~      The purpose of this study is to investigate safety (if there are any side effects) associated~     with the use of SABER™-Bupivacaine and how well it works in reducing pain and opioid-related~     side effects following shoulder surgery.~   "
209490|NCT00818792|"~     Percutaneous coronary intervention (PCI) with bare metal stent (BMS) in patients with renal~     insufficiency has shown unsatisfactory results. Indeed, drug-eluting stents (DES) might~     reduce the incidence of restenosis and therefore of target lesion revascularization~     procedures in these patients.~      We therefore designed a prospective, randomized, multicenter, not-sponsored study to directly~     compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent~     (Xience V) and bare-metal stent (Vision) (both 2nd-generation DES and BMS, respectively),~     both implanted in the same patient with multivessel disease and renal insufficiency in order~     to obviate for the multiple and unpredictable characteristics of this high-risk population.~   "
209491|NCT00818779|"~     The investigators aim to assess if a new blood pressure medication, aliskiren, reduces~     various biomarkers of heart disease found in the blood in patients with a history of both~     heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these~     biomarkers compared to a calcium channel blocker.~   "
209492|NCT00818766|"~     The purpose of this study is to evaluate if post-operative antibiotic prophylaxis decreases~     infectious complications when compared to pre-operative antibiotics alone, in patients~     undergoing elective thoracic surgery requiring tube thoracostomy (chest tube).~   "
209493|NCT00818753|"~     To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg~     twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a~     standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of~     elective percutaneous coronary intervention (PCI).~   "
209494|NCT00818740|"~     The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 in healthy~     volunteers.~   "
209495|NCT00818727|"~     SSRI treatment in adults was found to decrease bone density. The use of SSRI among pregnant~     women with depression or anxiety is extendent and raising. The effect of bone density of the~     infants was not yet evaluated.~   "
209496|NCT00818714|"~     SBRT to deliver a boost dose to residual primary tumor after definitive doses of standard~     EBRT have been delivered concurrently with chemotherapy.~      Serum levels of TGF-Beta1 and correlation with SBRT toxicity.~   "
209497|NCT00818701|"~     The purpose of the study is to show that low dose recombinant BNP coupled with~     phosphodiesterase V inhibition will improve renal dysfunction and promote relief of volume~     overload in patinets with acute decompensated heart failure complicated by the cardiorenal~     syndrome.~   "
209498|NCT00818688|"~     We performed a national cross-sectional and prospective large epidemiological cohort study in~     patients with ST. Office- and hospital-based vascular medicine French practitioners enrolled~     all consecutive patients with a symptomatic ST of the lower limbs at least 5 cm long~     documented by compression ultrasonography. Follow-up was three months. All events were~     adjudicated by a central committee.~   "
209499|NCT00818675|"~     This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC~     who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS~     mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an~     assessment of disease status. Patients assessed by the investigator to have stable disease~     after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo.~     Patients assessed to have partial or complete response will continue on open-label~     ridaforolimus. Patients assessed to have disease progression will be discontinued from study.~   "
209500|NCT00818662|"~     The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune~     Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion~     compared with placebo in participants with mild to moderate Alzheimer's disease (AD).~   "
209501|NCT00818649|"~     RATIONALE: Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Giving bortezomib together with vorinostat may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with vorinostat~     works in treating patients with high-risk myelodysplastic syndrome or acute myelogenous~     leukemia.~   "
209502|NCT00818636|"~     ***Please note that this study does not offer comprehensive treatment program for alcohol~     abuse or depression. Please do not contact the study staff if you are seeking psychological~     treatment. Further, this study is only enrolling people who are clients at Career and~     Recovery Resources, Inc., in Houston.~      The hypothesis is that writing about feelings and thoughts will help people who are in group~     treatment feel less depressed and abuse alcohol less.~   "
209503|NCT00818623|"~     The purpose of this trial was to find an optimal dose for a new trial drug - degarelix~     (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was~     studied. Patients participating were treated with FE200486 on one occasion. Thereafter they~     came in for visits following a specific schedule until blood samples showed that there was no~     further effect.~   "
209504|NCT00818610|"~     The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not~     inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with~     community-acquired pneumonia.~   "
209505|NCT00818597|"~     The purpose of this study is to investigate the effect of an extracorporeal application of a~     bed-side bioreactor containing human donor granulocytes on the course and outcome of septic~     shock in humans.~   "
209506|NCT00818584|"~     This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates~     with suspected candida infection~   "
209507|NCT00818571|"~     This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal~     impaired patients~   "
209508|NCT00818558|"~     The aim of this study is, i) to assess the presence and the frequency of CTC in NSCLC~     patients undergoing surgery by using cytopathological analysis after their isolation by size~     (ISET method), and, ii) to correlate the presence of CNHC with pTNM stage, histological~     subtype, and percentage of tumor cells present into the primary tumors.~   "
209535|NCT00818207|"~     This study is based on the hypothesis that access to smoking cessation treatment (SCT)~     reimbursement may significantly increase the number of successful quitters in a population of~     smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by~     improving subject adherence to treatment.~   "
209536|NCT00818194|"~     The purpose of this study is to compare the effects of steady state tacrolimus vs.~     cyclosporine on renal pharmacodynamics in healthy volunteers.~   "
209509|NCT00818545|"~     The stratum corneum (SC) is the superficial layer of the epidermis situated at the interface~     between the body and its outside environment. Its strategic position confers it a crucial~     role of protection against aggressions. After disruption, the kinetic of cutaneous barrier is~     slower in elderly comparatively to young subjects.~      The purpose of this study is to investigate, by characterizing molecular events, the~     effectiveness of ER4017 (Hydroxypropyltetrahydropyrantriol) to restore kinetic barrier~     function after acute disruption of stratum corneum in ederly subjects.~      10 male volunteers aged from 60 to 75 years are randomized to receive topical application of~     ER4017 versus placebo on skin inner forearms twice a day during 3 months. After sequential~     selloptape strips, epidermal samples of treated and control skin are removed under local~     anesthesia, using a dermatome. Differential gene expression analysis is performed using micro~     array techniques and quantitative RT-PCR.~      treatment, randomized on the location, double blind, placebo control, internal control~     subject, prospective study.~   "
209510|NCT00818532|"~     To assess which commercially available measurement device is most accurate in measuring low~     (< 1.0 D) degrees of corneal astigmatism.~   "
209511|NCT00818519|"~     The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg /~     ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne~     vulgaris over 6 treatment cycles.~   "
209512|NCT00818506|"~     Studies show that depression is a risk factor for the development of coronary artery disease~     (CAD). Furthermore there is an increased occurrence of depression in patients with CAD. Among~     other mechanisms atherosclerosis is believed to play a central role regarding these notable~     associations between depression and CAD. Moreover, patients with late onset major depression~     have an increased number of small lesions found in the white matter of the brain, the~     so-called white matter lesions. The main goal of this project is to examine if CAD is~     associated with depression and/or white matter lesions. CAD is evaluated using coronary CT~     angiography. Depression is evaluated using a semi-structured diagnostic interview. White~     matter lesions are quantified using cerebral magnetic resonance.~   "
209513|NCT00818493|"~     This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in~     patients who have undergone primary unilateral total knee arthroplasty or total hip~     arthroplasty.~   "
209514|NCT00818480|"~     This protocol is open to subjects previously enrolled in and who had completed a Phase I or~     Phase II study administering YM155. Subjects who are receiving benefit from treatment with~     YM155 are eligible after completing the previous study.~   "
209515|NCT00818467|"~     Patients need vitamin D which is normally produced in the skin in response to ultraviolet~     light from the sun. Vitamin D is important for calcium absorption and good bone health.~     Physicians have been using sunscreens to protect patients from skin cancer and the aging~     effects of sunlight for a least a half a century. Dermatologists have promoted sunscreen use~     to restrict sunlight exposure especially in white Caucasians. If this behavior is done 100%~     of the time when outdoors individuals may suffer from vitamin D deficiency. It is impossible~     to influence persons' behavior to wear sunscreens all the time when outdoors. With the use of~     sunless tanning agent (DHA), once a week, we can obtain a continuous sunscreen in the top~     layer of the skin that will not wash off, can't be removed with soap and water, or removed by~     perspiration. Under these circumstances we can answer the scientific question, will sunscreen~     use inhibit the production of vitamin D in the skin?~   "
209516|NCT00818454|"~     The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI~     with albuterol HFA MDI, the current standard reliever medication in asthma. In the first~     cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC~     MDI will be used. In the second, parallel group part of the trial (Treatment Phase 3)~     COMBIVENT RESPIMAT will be tested for acute bronchodilator efficacy in a blinded manner at~     the clinic visits. During the third 4-week treatment phase open label COMBIVENT RESPIMAT will~     be used for symptom relief as needed.~   "
209517|NCT00818441|"~     This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in~     patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or~     pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15~     years) or have known EGFR activating mutation; or patients with HER 2 amplification or~     mutation.~   "
209518|NCT00818428|"~     Recent research reveals genetic and symptomatic overlap among children with speech sound~     disorders (i.e., those who (misarticulate more sounds than would be expected for their age)~     and children with dyslexia (i.e., those who struggle to learn to read). Children who have~     speech sound disorders as preschoolers are at risk for the later emergence of dyslexia, a~     risk that often reveals itself in the form of poor phonological awareness skills during the~     preschool period. Traditional speech therapy methods focus on articulation accuracy and do~     not focus on the child's more abstract knowledge of the sound system of the language. The~     ultimate objective of this research program is to prevent reading disability in children who~     present with speech sounds disorders. The relative effectiveness of different interventions~     to help these children achieve age-appropriate phonological processing skills prior to school~     entry will be investigated. It is expected that a combination of treatment approaches that~     focus on speech perception skills and vocabulary knowledge will have a superior impact on~     phonological awareness in comparison with a treatment approach that focuses solely on~     articulation accuracy.~   "
209519|NCT00818415|"~     To determine the pharmacokinetic profile of the investigational product following dosing~     under fed conditions.~   "
209520|NCT00818402|"~     The principal objective is to study clinical observations, symptoms and quality of life of~     non-small-cell lung cancer (NSCLC) patients undergoing specific non-operative treatment for~     cancer, including chemotherapy and radiotherapy.~   "
209521|NCT00818389|"~     The purpose of this study is to compare the effectiveness of lithium combined with riluzole~     to riluzole combined with placebo in people with amyotrophic lateral sclerosis.~   "
209522|NCT00818376|"~     The presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not~     been evaluated especially because most studies utilized a previous disruption of biofilms in~     all dental surfaces before the beginning of rinsing. The purpose of this study is to compare~     staining and calculus formation after 0.12 percent chlorhexidine between previously~     plaque-free and plaque-covered surfaces by means of an experimental gingivitis model.~   "
209524|NCT00818350|"~     Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic~     bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a~     similar efficacy but less toxicity.~      Almost all responding patients relapse within the first year, with a median survival of 12~     months. Prognosis is very poor in patients who display progressive disease after receiving~     combination cisplatin-based chemotherapy.~      No standard has yet been established for second-line treatment and well designed trials of~     second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be~     given high priority.~      Several drugs have been used in second line for metastatic disease with poor results.~      The investigators have planned a Phase II study, open-label, single arm design to evaluate~     the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with~     standard regimen (cisplatin-gemcitabine).~      No previous studies have been published with sunitinib in metastatic bladder cancer.~   "
209525|NCT00818337|"~     The objective of this pilot study is to evaluate the prevalence of biological aspirin~     resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness~     will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women~     identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then~     re-tested for aspirin responsiveness.~   "
209526|NCT00818324|"~     The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic~     suspension during 52 weeks in dry eye patients~   "
209527|NCT00818311|"~     Photomodulation is a process which manipulates or regulates cell activity using light sources~     without thermal effect. Different studies have investigated the use of non-thermal low dose~     light emitting diode (LED) array for improving the appearance of photo aging damage. The~     photomodulation concept includes a low energy, narrow band or coherent light with specific~     pulse sequences and durations.~      Preliminary investigations done by McDaniel et al. demonstrated that fibroblast activity~     could be regulated using pulsing light at specific wavelenghts. Using a variety of LED light~     sources, his group has demonstrated that by varying light pulses and other parameters,~     procollagen synthesis could be upregulated in human skin fibroblast culture [McDaniel DH, et~     al.Lasers Surg Med. 2002; 14-251]. A clinical correlation was also shown based on different~     clinical trials data on around 1000 subjects, LED has shown up to 90% improvement in wrinkles~     and an increase of collagen synthesis versus control with little or no side effects~     associated [Weiss, RA et al. Lasers Surg Med 2005; 36(2): 85-91- Weiss, RA et al.: J Drugs~     Dermatol 2004; 3(6): 605-610 - Weiss RA et al. Dermatol Surg 2005; 31(9):1999-1204 - Russel~     BA et al. J Cosmet Laser Ther 2005; 7 (3-4):196-200 - Bhat J et al. Laser Med Sci 2005;~     20(1):6-10]. Based on these promising clinical data, Light BioScience submitted a dossier to~     the Food and Drug Administration (FDA) and obtained in January 2005 the FDA approval for its~     GentleWaves® Light Emitting Diode (LED) for the non-invasive treatment of periorbital (eye~     area) wrinkles and rhytids. The LED technology has been considered by FDA as non significant~     risk. In Europe, the GentleWaves® Light Emitting Diode has obtained the notified body~     certification for the same indication. This medical claim is associated with cosmetic~     improvement of aging and sun-damaged skin, further validation the science of LED~     photomodulation skin rejuvenation [Investigator's Brochure. Version 1].~      This approval has been obtained with a professional LED GentleWaves® device used under a~     physician's responsibility. The initial regimen of 35 seconds twice per week with at least~     two days in between treatment for a total of 4 weeks duration of treatment has demonstrated~     efficacy for the treatment of typical signs of photo aging and no adverse effect.~      A monocentre, randomized clinical study.~   "
209528|NCT00818298|"~     Ziprasidone is recommended to be dosed twice daily for the treatment of schizophrenia, based~     on peripheral pharmacokinetics and a knowledge of its half life in plasma level (5-10 hours).~     However, the plasma kinetics do not always mirror what occurs in the brain. Antipsychotics~     with a high-affinity at D2 receptors attach for a relatively long time to their binding sites~     even after plasma levels declined. Based on this observation, another antipsychotic with a~     similar high-affinity at D2 receptors, ziprasidone, would also be expected to keep a~     sufficiently high D2 receptor occupancy even 24 hours after the last dose.~      Given >60% D2 occupancy is required to maximize chance of therapeutic efficacy, it would be~     valuable to assess the D2 receptor occupancy 24 hours postdose to predict the therapeutic~     effects of once-daily regimen. In this study, we will measure D2 receptor occupancy 6, 12,~     and 24 hours after the last dose of ziprasidone in patients with schizophrenia.~      The hypotheses are as follows: First, based on the known affinity of ziprasidone, the~     dopamine D2 occupancy 24 hours after the last administered dose of 80 mg will be >60%.~     Second, the difference in dopamine D2 occupancy between scan at 6 hours and 24 hours will be~     less than 15%. Third, the difference in dopamine D2 occupancy between scan at 12 hours and 24~     hours will be less than 10%. Fourth, ED50 24 hours post dose will be higher that those 6 and~     12 hours postdose.~   "
209529|NCT00818285|"~     Drug-related illness accounts for 5% to 23% of hospital admissions, and is now claimed to be~     the sixth leading cause of mortality. Older adults are at higher risk of adverse drug-related~     events, and medication-related fall injuries are the most common adverse event that could be~     potentially prevented. There are 1.2 million falls per year among Canadian elderly, at a cost~     of $2.4 billion in health care services, and substantial risk of loss of independence.~      The overall purpose of this research program is to reduce medication-related fall injuries by~     using computerized electronic prescribing and drug management systems to identify high risk~     patients and provide physicians with patient-specific recommendations for modifying~     psychotropic medication use to reduce this risk.~   "
209530|NCT00818272|"~     This observational study is in line with the German educational plan with the aim to~     implement a tool to increase and monitor the awareness for tuberculosis screening and to~     reinforce the patient eligibility for a treatment with Remicade according to the Summary of~     Product Characteristics (SmPc).~   "
209531|NCT00818259|"~     This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for~     the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0~     months to 17 years of age.~   "
209532|NCT00818246|"~     The purpose of this study was to determine whether light emitting diode (LED) therapy can~     improve skin appearance of human subjects with aged/photoaged skin. A reduction in rhytid~     depth as well as in skin surface roughness and in the degree of elastosis after LED~     treatments was expected.~   "
209533|NCT00818233|"~     The aim of the protocol is to document intra-observer and inter-observer variability with~     dynamic contour tonometry, and will also test the theory that pulse amplitude, as measured by~     dynamic contour tonometry, is correlated with the difference in systolic and diastolic blood~     pressures.~   "
209534|NCT00818220|"~     The purpose of this study is to determine whether the intervention of delaying cord clamping~     for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the~     VLBW infants below the introitus will result in less bleeding in the brain and fewer~     infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7~     months corrected age. The investigators will attempt to identify the mechanisms of effect~     through measurement of biologic markers.~   "
209538|NCT00818168|"~     This observational study is in line with the German educational plan with the aim to~     implement a tool to increase and monitor the awareness of tuberculosis screening and to~     reinforce the patient eligibility for a treatment with Remicade according to the Summary of~     Product Characteristics (SmPc).~   "
209539|NCT00818155|"~     The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine~     succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and~     the effects of the drug will also be evaluated.~   "
209540|NCT00818142|"~     We propose to conduct a monthly group of persons with type 1 diabetes who also withhold~     insulin. Subjects will be asked to complete a 2-page survey (check-in sheet) at the beginning~     of each session and a 5-page survey (Diabetes and Eating Disorders Survey) on their first~     session and at their last session of their group.~   "
209541|NCT00818129|"~     The primary objective of this study is to investigate the safety and tolerability of single~     and multiple oral doses of AZD7295 in healthy male Japanese subjects. This will be done by~     comparing the effect of AZD7295 to placebo. The study will aslo investigate the absorption,~     distribution and disappearance of AZD7295 in the body.~   "
209542|NCT00818116|"~     The objective of this study is to evaluate postoperative visual function in patients~     implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).~   "
209543|NCT00818103|"~     Compared with MS in white populations, in people of China descent multiple sclerosis (MS)is~     characterized by lower prevalence, more frequent and severe involvement of the visual system~     at onset and during the entire clinical course, more common occurrence of optic and spinal~     involvement, relatively rapid progression and less common occurrence of a progressive course.~     Data are not available for mainland China that are focused on characteristic studies of MS.~     In this study, the investigators sought to explore the characteristics of MS among Chinese in~     China, by conducting a study on genetics, pathogenesis, pathology, neuroimaging~     characteristics, and so on. Based on these data, the investigators try to explore the~     difference in neuromyelitis optical (NMO) and MS and provide clinical data for treatment~     guidelines for NNO and MS.~   "
209544|NCT00818090|"~     To assess the efficacy and safety of the regimen in previously untreated, unresectable~     invasive thymoma or thymic carcinoma~   "
209545|NCT00818077|"~     This study will look at the impact that meals have on blood glucose (sugar) levels. Subjects~     will be asked to use a Continuous Glucose Monitoring System (CGM), which monitors glucose~     levels continuously. Breakfast and lunch meals will be provided and must be consumed at the~     International Diabetes Center.~   "
209546|NCT00818064|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients~     with rheumatoid arthritis (RA).~   "
209547|NCT00818051|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose~     of radiation directly to the tumor may kill more tumor cells and cause less damage to normal~     tissue. It is not yet known which radiation therapy schedule is more effective in treating~     breast cancer.~      PURPOSE: This randomized phase III trial is studying three different radiation therapy~     schedules to compare how well they work in treating women who have undergone breast~     conservation surgery and systemic therapy for early breast cancer.~   "
209548|NCT00818038|"~     The primary objective of the study was to measure the change in bladder function as measured~     by Urogenital Distress Inventory (UDI)-6 compared to baseline over 6 months of Tysabri~     treatment. Secondary objectives were to (i) measure change from baseline over 6 months of~     Tysabri treatment in the number of urinary incontinence episodes per participant per week,~     (ii) measure change from baseline over 6 months of Tysabri treatment in the number of~     micturitions per participant per day, (iii) measure change in The North American Research~     Committee on Multiple Sclerosis (NARCOMS) bladder/bowel subscale (PSB) scores from baseline~     over 6 months of Tysabri treatment and (iv) measure change in Incontinence Impact~     Questionnaire (IIQ)-7 scores from baseline over 6 months of Tysabri treatment.~   "
209549|NCT00818025|"~     The purpose of this randomized controlled trial is to test the efficacy of a novel~     intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care~     agency, self-care behaviors, and transplant-related health.~   "
209550|NCT00818012|"~     This study aims to evaluate the utility of the atrial electromechanical interval and pulse~     wave velocity in the prediction of recurrence of atrial fibrillation among patients who~     underwent successful direct current cardioversion for atrial fibrillation.~   "
209551|NCT00817999|"~     This study will measure the percentage of platelet aggregation inhibition with a loading dose~     of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank~     11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation~     inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay~     System in healthy volunteers who have drank 11 oz grapefruit juice daily.~   "
209552|NCT00817986|"~     The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil~     sustained release tablets taken every 12 hours compared to placebo in subjects with acute~     back spasms in the lumbar region.~   "
209553|NCT00817973|"~     Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular~     risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates~     profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little~     information exists about the effect of proteins.~      The purpose of this study is to compare the effects of the proteins casein, whey, cod, and~     gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.~   "
209566|NCT00817791|"~     Animal studies have shown that preconditioning with hyperbaric oxygen can induce central~     nervous system and heart ischemic tolerance. This study was designed to determine the~     protective effect of hyperbaric oxygen preconditioning on brain and myocardium~     ischemia-reperfusion injury during coronary artery bypass graft surgery.~   "
209567|NCT00817778|"~     The purpose of this study is to assess the 1 month safety and tolerability after multiple~     oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin~   "
214391|NCT00753493|"~     The aims of this study are to determine, in adult patients on maintenance topiramate therapy,~     the steady-state pharmacokinetics and safety of orally and intravenously administered~     topiramate.~   "
209554|NCT00817960|"~     Experimental design overview The proposed project is a prospective experimental study design.~     independent old adults(age 65 years old and older) who do not suffer from balance problems~     willing to participate in the study will be tested with well-established measuring techniques~     of Balance control before and 2 hours after taking of Methylphenidate (Ritalin) in the~     movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract~     standardized stabilogram-diffusion parameters from each of the COP data sets collected during~     quiet standing. These parameters include diffusion coefficients, critical displacement,~     critical time and scaling exponents for both lateral and anterior-posterior sway directions~     (Collins & De Luca, 1993). For each of the conditions (before and 1 hour after the use of~     Ritalin) in three task conditions single task; dual task (concentrating and identifying~     specific music); and just Listening to a relaxing music. Participants will be required to~     stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as~     little as possible.~   "
209555|NCT00817947|"~     High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous~     clearance compared with control. These observations led to the development of 'The Vest'~     which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient~     over the chest wall. The generator rapidly inflates and deflates 'The Vest' which gently~     compresses and releases the chest wall between 5 and 20 times per second. This generates~     mini-coughs which are said to dislodge mucus from the bronchial walls and to facilitate its~     movement up the airways. In addition 'The Vest' has been shown to reduce the viscosity of~     mucus and this should further enhance mucous clearance. The technique has, for many years,~     been widely used in the United States of America as an alternative to the European airway~     clearance regimens of the active cycle of breathing techniques, autogenic drainage, positive~     expiratory pressure and oscillating positive expiratory pressure, but 'The Vest' has only~     recently been registered for use in Europe. It is important that the airway clearance regimen~     of 'The Vest' be compared with the alternative airway clearance regimens widely used in~     Europe.~      Hypothesis: In people with cystic fibrosis 'The Vest' will lead to the expectoration of an~     increased weight of sputum during treatment sessions compared with alternative airway~     clearance regimens.~   "
209556|NCT00817934|"~     The purpose of this study is determine if the AB Prep (a 16 tablets colon cleansing prep), is~     an effective, and safe colon cleansing prep in preparation for colonoscopy, and severe~     constipation.~   "
209557|NCT00817921|"~     Purpose of the study:~        1. To evaluate the effect of prematurity on renal function in 5 years old children~        2. To compare former premature children treated by ibuprofen in the neonatal period to~          controls~   "
209558|NCT00817908|"~     Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a~     transplant. Serious infections due to CMV can affect many parts of the body including the~     lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have~     evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or~     valganciclovir). Despite this, there are a chance that CMV infection may cause problems in~     the future. The purpose of this study is to assess how well patients'immune systems responds~     to the CMV virus, so that in the future it may be possible to predict which patients are at~     highest risk of CMV.~   "
209559|NCT00817895|"~     Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly~     influence it's prognosis, especially for the patient with tumor >5cm, multiple tumor and who~     cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted~     into the liver incisal margin after tumor was resected could reduce the recurrence rate of~     HCC after liver resection.According to this, we proceed this RCT to prospectively observe the~     effect of sustained released 5-FU,and we also want to know whether combined with sustained~     released cisplatin will get better effect in preventing the tumor recurrence,especially in~     short time after liver resection.~   "
209560|NCT00817882|"~     Back pain has a major impact on people's ability to work. Health professionals need to know~     how they can best use their limited resources to address the occupational needs of people~     with chronic low back pain. Vocational rehabilitation is the process that helps people with~     health problems to stay at, return to and remain at work. This study comprises the second~     phase of a three year study of back pain and vocational rehabilitation. The first phase~     gathered data from patient interviews and postal surveys of GPs and GP practice managers.~     These findings have been used to inform this second phase; a feasibility randomised~     controlled trial. The participants will be thirty employed people with back pain who have~     been offered an NHS rehabilitation programme, and who are concerned about their ability to~     work with low back pain. Those who consent will be randomised into two groups. One group will~     receive routine rehabilitation. The other will receive routine rehabilitation plus an~     individually tailored vocational intervention carried out by the researcher. Following the~     trial, individual interviews will be carried out with each of the participants by an~     independent researcher. An economic study will evaluate the possibility of measuring the~     cost-effectiveness of the intervention. The hypothesis is that an enhanced vocational~     intervention plus routine rehabilitation will be more effective in improving patients' work~     ability than routine rehabilitation alone.~   "
209561|NCT00817869|"~     In hospitals, older people can fall and hurt themselves. The investigators want to see if a~     new type of flooring can help stop people hurting themselves as badly, if they accidentally~     fall.~   "
209562|NCT00817843|"~     The purpose of this study is to investigate whether low-dose simvastatin in combination with~     ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the~     function of the endothelium after an oral fat load in patients with metabolic syndrome.~   "
209563|NCT00817830|"~     The purpose of this study is to assess the safety of lodenafil carbonate in patients with~     coronaropathy, evaluating the response of the body facing physical effort, including both~     heart and respiratory components, with and without use of lodenafil carbonate 80mg.~   "
209564|NCT00817817|"~     This is an open-label, comparative, randomized, parallel, multicenter study in asthmatics to~     determine whether the administration of dry powder inhaled mometasone furoate (MF) 400 μg in~     a monodose capsule device would be comparable to administration of powder inhaled MF 400 μg~     in a multidose device.~   "
209565|NCT00817804|"~     The purpose of this study is to compare a new noninvasive ventilator to existing ventilators~     already used for patient care.~   "
209568|NCT00817765|"~     The purpose of this study is to determine the influence of posaconazole on unboosted~     fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is~     to determine the safety of combined use of fosamprenavir with posaconazole in healthy~     volunteers.~   "
209569|NCT00817752|"~     Ayurvedic medicine has been practiced in for more than 2,500 years. Ashwagandha is one of the~     most widely utilized herbs in the system. It is thought to affect the endocrine, immune,~     nervous, and cardiopulmonary systems. This study is designed as a preliminary investigation~     of the effects of Ashwagandha on stress, inflammation, and immune modulation. Participants~     will take the liquid extract in cow's milk twice a day for five days. The results of initial,~     one-day, and final blood draws will be compared to determine participant's beginning and~     ending levels of cortisol, inflammatory cytokines, and immune-cell activation (CD4 T-cells,~     CD8 T-cells, B cells and natural killer cells). Measurements will be completed using flow~     cytometry and ELISA assay. The purpose of this study is to determine which effects of~     Ashwagandha are most suitable for further investigation.~   "
209570|NCT00817739|"~     This study is aimed at evaluating the effects of intermittent hormonal treatment with~     complete androgen suppression (Leuprorelin 3.75 milligram [mg] sustained release [SR] and~     Flutamide) in patients presenting with stage D2 or Tx Nx M1 ≠ M1a metastatic prostrate~     cancer, with a prostate specific antigen (PSA) level 5-fold higher than normal (PSA greater~     than or equal to [≥] 20 nanogram per milliliter [ng/mL], as quantitated by the Hybritech~     radioimmunoassay) and with a subsequent decline to normal (PSA less than [<] 4 ng/mL) during~     the initial 6 months of induction treatment. The results will be compared with those obtained~     after continuous hormonal therapy with complete androgen suppression.~   "
209571|NCT00817726|"~     -  Purpose - to validate a combination of biological and clinical markers in the~          rapid-eye-movement (REM) sleep behavior disorder (RBD) population as indicative of the~          pre-symptomatic stage of Parkinson's disease (PD).~        -  Procedures - All subjects (RBD diagnosis and controls) will have 1) a medical and neuro~          history and physical including videotape of movements, 2) neuropsychological testing, 3)~          a sleep study, 4) olfactory testing, 5) blood draw for serum testing , 6) functional~          MRI. All of these procedures are often performed clinically in the diagnosis of PD.~          Enrollment of subjects with PD is complete. Any testing performed prior to enrollment as~          part of the clinical evaluation may be used in place of repeating the procedure for the~          study. Subjects will be followed for 5 years. It is hypothesized that a 5 year follow up~          may capture a significant number of pre-Parkinson's subjects who will be diagnosed.~          Subjects may be offered a repeat enrollment after 5 years.~   "
209572|NCT00817713|"~     This study focuses on one of the major health issues of Sub-Saharan Africa: multi-parasitism~     and co-infections. In particular this study aims to elucidate the interaction of helminths~     with HIV.~      There is good reason to suspect a detrimental effect of helminth infection on the course of~     HIV infection. We hypothesize, that treatment of helminths in HIV- and helminth co-infected~     individuals leads to a reduction of HIV viral load. With a lower HIV RNA level one would~     expect a slower decline of CD4 cells and hence also a slower progression of the disease.~     Ideally this would lead to a prolongation of the chronic phase of HIV infection and to a~     delay in the time when anti-retroviral treatment needs to be started.~   "
209573|NCT00817700|"~     This project has 6 aims.~        1. To examine the impact of recurrent partial sleep loss in young, middle-aged and older~          men and women. Sleep will be restricted to 4 hours.~        2. To test the hypothesis that extending bedtimes to allow for sleep recovery will reverse~          the metabolic, endocrine, and cardiovascular and neuro-behavioral alterations resulting~          from sleep restriction. Sleep will be extended to 12 hours following the 4 hour sleep~          restriction.~        3. To test the hypothesis that there are age and gender differences in the total amount of~          sleep recovery obtained during the week of 12-hour bedtimes.~        4. To test the hypothesis that there are age and gender differences in sleep capacity (the~          amount of time an individual can sleep per night when there is no sleep debt).~        5. To test the hypothesis that sleep capacity is partly determined by baseline levels of~          slow-wave sleep and slow-wave activity.~        6. To determine whether sleep capacity is related to sleep need by examining metabolic,~          endocrine, cardiovascular and neuro-behavioral changes with the amount of the individual~          sleep debt.~   "
209574|NCT00817687|"~     This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in~     patients who have received a kidney transplant from an expanded criteria donor. Patients will~     be randomized to one of two groups; the first group will have a biopsy at day 10, and the~     second group will receive standard management. All patients will be given CellCept as~     standard of care. The anticipated time on study treatment is 1 year, and the target sample~     size is 100-500 individuals.~   "
209575|NCT00817674|"~     To test if usual at home night time sleep duration as measured with activity monitors and~     questionnaires will predict changes in kidney function as measured by kidney filtration rate~     and of cardiovascular function as measured by C-reactive protein in the blood. The study will~     explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk~     factor for the progression of CKD and for the development of cardiovascular disease in CKD.~   "
209591|NCT00817466|"~     Bronchiolitis is a common lower respiratory disease typically affecting infants and children~     generally younger than 2 years of age. The disease leads to hospital admissions, is a major~     cause for hospitalisation of young children and infants during winter epidemics, may be~     severe sometimes requiring ventilatory support and rarely death. The clinical disease as~     described by Court is characterised by nasal flaring, tachypnoea, dyspnoea, chest recessions,~     crepitations and sometimes sibiliations. Respiratory Syncytial virus is the most common~     cause, but also other respiratory vira may cause the disease. Bronchiolitis is a well known~     risk factor of asthma development in childhood1,2.~      Management is generally supportive, whereas symptom reducing therapy is debated with no~     international consensus. Furthermore, there are many unresolved questions related to the~     prognosis of bronchiolitis, its role in development of chronic lung disease in particular~     regarding the association between early bronchiolitis and asthma development. The present~     project will particularly focus on: 1)Treatment efficacy related to various outcomes during~     active disease, 2) retrospectively assess treatment efficacy in relation to later development~     of allergic disease, 3) assess the role between different vira and asthma prognosis as well~     as 4) identify possible prognostic factors involved in the progression from bronchiolitis to~     further airways disease.~   "
209576|NCT00817661|"~     Influenza viral infection can cause serious illness among young infants 0-6 months of age.~     However, inactivated influenza vaccine is not recommended for this age group but pregnant~     women can be vaccinated during 2nd - 3rd trimester to induce passive immunization of their~     infants. Nevertheless vitamin A deficiency is highly prevalent among pregnant women in~     Bangladesh, >50% pregnant women consume less vitamin A than the recommended level. Given the~     fact that both clinical and sub-clinical vitamin A deficiency impair vaccine specific~     immunity, in this proposed study, we aim to investigate whether maternal vitamin A~     supplementation improve influenza vaccine specific immune responses among pregnant women and~     the passive protection of their infants.~      In a placebo controlled clinical trial, sixty six mothers will be randomly assigned to~     receive either 10,000 IU vitamin A or placebo capsules weekly from second trimester to 6~     month postnatal period. At 26-28 weeks of gestation, all mothers will be vaccinated with~     inactivated, trivalent influenza virus vaccine. Maternal and cord blood will be collected for~     vitamin A and influenza virus specific IgG assessment. Colostrum and breast milk at 6-month~     will be collected for vitamin A and influenza virus specific secretory IgA assessment. Venous~     blood (2-3 ml) will be obtained from all infants at the age of 6 months for vitamin A and~     influenza virus specific IgG assessment as well as infants' nasal swab for influenza virus~     specific secretory IgA.~   "
209577|NCT00817648|"~     The primary objective of this study is to evaluate the efficacy of seroquel in the treatment~     of patients with acute schizophrenia compared with risperidone by evaluating the change of~     PANSS total score from the baseline to week 6.~   "
209578|NCT00817635|"~     This study will assess the blood pressure effect, safety and tolerability of LCI699 compared~     to placebo and eplerenone in patients with resistant hypertension.~   "
209579|NCT00817622|"~     The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic~     Acid)alone and with VitE in diabetic patients.~   "
209580|NCT00817609|"~     This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao,~     Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a~     better effect in restoring consciousness for patients who have suffered from an acute~     ischemic stroke. The study is designed to look at both consciousness level and overall~     recovery and recovery of motor function, for example muscle strength and coordination.~   "
209581|NCT00817596|"~     Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to~     accurately supply drug to the intrathecal space for the treatment of chronic pain.~   "
209582|NCT00817583|"~     The primary objective of this study is to determine the response rate, tolerance and overall~     survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF~     regimen) and concurrent chemoradiation.~      Secondary objectives of the study are to evaluate the distant metastases free survival, and~     disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.~      The third objective of this study is to evaluate who may benifit from this treatment regimen.~   "
209583|NCT00817570|"~     The purpose of this study is to test and compare the balance reactions of Tranfemoral~     Amputees and able bodied subjects in response to perturbations given by a highly advanced~     Virtual Reality system.~   "
209584|NCT00817557|"~     Study of the effects of Loteprednol on CL dryness~   "
209585|NCT00817544|"~     The study is conducted to examine absorption of C14-ORM-12741 from intestine to bloodstream,~     distribution to bloodstream, metabolism in the liver and excretion of the parent drug and~     metabolites to faeces, urine and expired air~   "
209586|NCT00817531|"~     We want to learn if dasatinib will make triple negative breast cancers smaller. We also hope~     that we can learn more about what makes triple negative breast cancers grow. We believe this~     information will help us to predict which patients will benefit from taking this drug or~     other drugs like it.~      This study is a neoadjuvant study, which means that it is only open to women who have not~     had any treatment for their breast cancer. Neoadjuvant studies allow the study doctor to look~     at how the cells in your cancer change after taking the study medication. This will help us~     to understand whether or not dasatinib is an effective treatment for breast cancer. It will~     also help us to learn more about triple negative breast cancer and how to treat it.~   "
209587|NCT00817518|"~     This study will determine the maximum tolerated dose and the dose-limiting toxicities of~     RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the~     study, groups of patients will be sequentially enrolled to receive ascending oral doses of~     RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent~     groups of patients after a successful assessment of the safety and tolerability of the~     previous dose. In Part 2 of the study, patients with metastatic or advanced malignant~     melanoma, or any other responsive tumor type, will be randomized to receive either the~     maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated~     time on study treatment is until disease progression, and the target sample size is <100~     individuals.~   "
209588|NCT00817505|"~     To evaluate the bioavailability of a tablet of AZD1656.~   "
209589|NCT00817492|"~     This study will help determine the relationship between impaired sleep and chronic kidney~     disease, specifically to determine if sleep disturbances are a risk factor for worsening~     kidney function.~   "
209590|NCT00817479|"~     The study objective is to compare changes in expression of glucocorticoid-induced genes that~     may be involved in cell survival signaling in the tumors of ovarian cancer patients before~     and after an intraoperative dose of 20mg dexamethasone.~   "
209630|NCT00816959|"~     Objective:~      The primary objective of the study is to evaluate the effect of R-mabHDI in patients with~     late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma.~      The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients~     with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant~     Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival.~     The study is also aimed at evaluating the safety of R-mabHDI .~      The aim of the study is to test this hypothesis by evaluating the clinical outcome in 1200~     patients receiving combination of R-mabHDI once a week for 8 weeks and ABVD therapy every~     other week for 12 treatments.~   "
209814|NCT00814554|"~     The aim of this study is to compare the effectiveness of three public health intervention~     strategies to reduce weight excess and obesity prevalence among teenagers within the frame of~     a public health program aiming at promoting healthy eating and physical activity behaviors.~   "
209592|NCT00817453|"~     Purpose:~        1. To see if cytokine levels and oligomeric alpha-synuclein levels in blood and~          cerebrospinal fluid could be used as biological markers for Parkinson's disease (PD)~          onset and progression.~        2. To characterize and define patterns in the clinical features of sleep, olfactory~          function and motor function in the early stages of idiopathic (sporadic) Parkinson's~          disease (PD)and atypical or late Parkinsonian Syndromes.~      Procedures:~      All subjects, control,early PD diagnosis and atypical or late Parkinsonian Syndromes, will~     have 1) a medical and neuro history and physical including videotaping of movements, 2)~     neuropsychological testing, 3) a sleep study, 4) olfactory (sense of smell) testing, 5)blood~     draw and LP for serum and CSF testing, & 6) functional MRI. All of these procedures are often~     done in the diagnosis of PD. Any test performed prior to enrollment as part of the clinical~     evaluation may be used in place of repeating the procedure. Subjects will have 1 set of study~     visits (up to 3 visits) in order to accomplish a complete set of data.~   "
209593|NCT00817440|"~     Hypothesis: under fasting there will primarily be an activation of growth hormone(GH)~     signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under~     physical activity.~      Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and~     fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max.~      In addition to this we will investigate the effect of fasting and exercise on the velocity of~     carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.~   "
209594|NCT00817427|"~     This study is designed to determine if either short night time sleep or poor night time sleep~     could be a risk factor for increasing the rate at which kidney function deteriorates in~     persons with mild to moderate kidney disease.~   "
209595|NCT00817414|"~     This study will determine the maximum dose of LCI6999 with respect to effect on the~     ACTH-stimulated cortisol response in patients with hypertension~   "
209596|NCT00817401|"~     Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and~     mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths~     globally and survivors suffer from long term neurological disability and impairment. Although~     many neuroprotective strategies appeared promising in animal models, most of them were not~     feasible and effective in human newborns. However, hypothermia was reported not to be~     effective if introduced beyond and thus should be introduced within 6 hrs after~     birth.Applying this selection criterion naturally would deprive many patients of the~     opportunity of hypothermia treatment.~   "
209597|NCT00817388|"~     Completion of a brief survey tool and providing an urine specimen. The study purpose is to~     improve our understanding of interstitial cystitis and painful pelvic syndrome.~   "
209598|NCT00817375|"~     The purpose of this study is to determine whether pharmacogenomic study predict~     antidepressant responsiveness in advance before the appearance of the drug effects until 4~6~     weeks after drug administration.~   "
209599|NCT00817362|"~     The purpose of this study is to see if IPI-504 in combination with trastuzamab is an~     effective treatment in HER2 positive metastatic breast cancer~   "
209600|NCT00817349|"~     Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional~     patient populations.~   "
209601|NCT00817336|"~     N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in~     neurocognitive dysfunction associated with schizophrenia. Further, several novel~     glutamate-based classes of compound are presently in development as potential novel~     treatments for persistent negative and cognitive symptoms. The study will assess~     effectiveness of a NMDA-based intervention on biomarkers related to schizophrenia as a~     mechanism for developing appropriate outcome batteries for future trials of novel compounds.~   "
209602|NCT00817323|"~     PURPOSE The purpose of this study is to elucidate whether quetiapine fumurate (Seroquel)~     exerts its antidepressant activity in bipolar disorder through altering either serotonergic~     or catecholinergic activity.~      HYPOTHESIS By depleting either serotonin or catecholamines in successfully treated bipolar~     patients, relapse will be induced and reveal which neurotransmitters are effected when~     receiving normal treatment~      JUSTIFICATION While the exact mechanism of action of the classical antidepressants is not~     fully understood, strong evidence implicating serotonin and noradrenalin to be necessary~     (albeit insufficient) for the resolution of depression comes from neurotransmitter depletion~     studies. This biological evidence for each of these two neurotransmitters come from study~     paradigms in which the neurotransmitter (or its precursor) are selectively and effectively~     depleted from patients who have responded to antidepressants which either work through~     enhancing serotonin (for example, SRI antidepressants) or catecholamines (such as secondary~     amine tricyclics, Reboxetine, etc.). It has been shown, and replicated, that patients that~     respond to serotonin enhancing drugs precipitously and dramatically relapse when given a diet~     (often in the form of a milkshake) which is void of tryptophan, the precursor of serotonin.~     This diet often contains other long-chain amino acids to prevent any residual tryptophan in~     the system from entering the CNS. These patients who have then relapsed on the~     tryptophan-free diet have their tryptophan repleted and their mood improves often over a very~     short time frame (for example, five hours). When this technique is performed on patients~     responding to catecholamine-enhancing drugs there is no significant clinical effect. A~     similar approach can be taken with patients who respond to noradrelanine-enhancing drugs.~     Specifically, their catecholamine stores can be depleted by using dietary tyrosine. This~     reduces the synthesis of catecholamines and dopamine thus depleting pre-synaptic~     noradrenaline. For patients who responded to noradrenaline-enhancing drugs, this results in a~     relapse in terms of depressive symptomatology. When this dietary tyrosine strategy is applied~     to serotonin responders, there is no significant clinical effect.~   "
209603|NCT00817310|"~     Currently, when premature infants develop severe intraventricular hemorrhage (IVH), a type of~     intracerebral bleed, there are no proven therapeutic interventions to prevent the devastating~     consequences of this event. These children will be likely to develop cerebral palsy or severe~     cognitive delays.~      The purpose of our study is to characterize differences in brain physiology, imaging, and~     function between premature infants with severe IVH and controls. The goals for gathering this~     information are to generate baseline data, which could facilitate early screening for~     complications of IVH in premature infants. These baseline data would also allow the design~     and implementation of early therapeutic interventions to help rehabilitate premature infants~     with severe IVH.~   "
209604|NCT00817297|"~     The purpose of this study is to compare a new noninvasive ventilator to existing ventilators~     already used for patient care.~   "
209631|NCT00816946|"~     This study aims to provide evidence regarding the feasibility of integrating an enhanced~     maternal and child care health education package into the existing curricula of the National~     Program for Family Planning and Primary Health Care (LHW Program) and evaluating the~     feasibility of scaling-up as well as the impact on birth outcomes, nutritional status,~     morbidity patterns and overall survival patterns at the community level.~   "
214729|NCT00749021|"~     This is a multicenter, randomized, open-label study. 40 patients will be followed for a~     period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg~     of intravitreal ranibizumab injection.~   "
209605|NCT00817284|"~     Significant activity (radiographic response rates of approximately 60%) has recently been~     demonstrated in phase II studies in patients with relapsed GBM from the combined use of~     Irinotecan (CPT-11) and bevacizumab. The 6-month progression-free survival rate is 30% and~     median survival duration is 9 months. The current first line therapy of GBM patients~     following initial surgical resection/debulking is the concomitant use of cerebral~     radiotherapy and the orally available alkylating agent temozolomide, followed by temozolomide~     for 6 months post-radiotherapy.~      Considering the significant activity of the combination of Bevacizumab + irinotecan in~     patients with recurrent GBM, and considering the activity of temozolomide in GBM, it is~     proposed that the combination of Bevacizumab + Temozolomide may also be an active regimen.~     Bevacizumab + Temozolomide display non-overlapping toxicity clinically and thus their~     combined use without significant dose-reductions seems rational.~      The toxicity from the combined use of the two drugs prior to radiotherapy, as well as the~     toxicity when administered together with radiotherapy, is evaluated.~      This study will try to identity whether Bevacizumab and Irinitecan or Bevacizumab and~     Temozolomide should be the experimental arm in future phase III comparison with standard care~     with concomitant Temozolomide and radiotherapy.~   "
209606|NCT00817271|"~     The purpose of this study is to evaluate the response to Glucagon versus the spontaneous~     hormonal response to low blood sugar levels in T2DM Patients treated with AZD1656 and~     Metformin~   "
209607|NCT00817258|"~     The primary objective of this study is to determine the overall survival in patients with~     stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy.~      Secondary objectives of the study are to evaluate the disease free survival, and distant~     metastases free survival of patients with stage II NPC treated with this regimen~   "
209608|NCT00817245|"~     Etiology of ICSCR is not known however recent studies regard the role of immunologic and~     infectious processes in the pathogenesis of ICSCR.one of these hypothesis is the role of~     helicobacter pylori in the pathogenesis of ICSCR so perhaps treatment of h pylori have~     positive effect on the remission of ICSCR.~   "
209609|NCT00817232|"~     Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain~     and disability. Treatment of the disorder is not always successful, and it often recurs or~     becomes chronic. More effective management options are required. There is evidence that~     electric microcurrent can promote tissue healing and symptom resolution in various chronic~     hard and soft tissue disorders, but few human studies investigating its use with chronic~     tendon problems. It is an easily applied therapy with very few reports of side effects. It~     can be applied at home using a portable unit and, if it is clinically effective, may also~     prove more cost effective than other therapies.~      A clinical trial is planned to evaluate the therapy but, in the absence of relevant published~     evidence, a preliminary study is required to look for a treatment effect and inform a power~     calculation for sample size, The study will also allow some investigation of dose-dependence,~     which is a key issue in many forms of electrotherapy. Finally it will enable evaluation of~     elements of the full trial protocol so that any weaknesses can be addressed before it begins.~   "
209610|NCT00817219|"~     The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX~     ointment in adolescent patients with psoriasis vulgaris.~   "
209611|NCT00817206|"~     This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3~     controlled trial to establish the efficacy and safety of conversion from maintenance~     immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc.,~     Deerfield, IL) twice daily to maintenance immunotherapy with LCP Tacro™ tablets (tacrolimus,~     LifeCycle Pharma A/S, Hoersholm, Denmark) once daily for the prevention of acute allograft~     rejection in stable adult kidney transplant patients. Patients on a stable dose of Prograf®~     will be randomly assigned to be converted from Prograf® twice daily to LCP Tacro™ once daily~     or to remain on maintenance therapy with Prograf® twice daily. Patients entering the study~     will be treated with assigned study drug and followed for one year for patient survival and~     the incidence of graft rejection or graft loss.~   "
209612|NCT00817193|"~     The purpose of this study is to test the effectiveness of a structured physical activity~     program, relative to a wellness program, in preventing the onset and progression of~     disability in the setting of senior housing communities, which are sometimes called housing~     with services.~   "
209613|NCT00817180|"~     This study is a preliminary study designed to determine the safety and effectiveness of HFCWO~     using the InCourage vest system as an airway clearance technique for the treatment of CF. The~     study will compare HFCWO to the most commonly used airway clearance technique in Canada,~     namely the Positive Expiratory Pressure technique in patients with CF over a period of one~     year. As this is a preliminary study, it will not be able to determine if the vest is~     equivelant to PEP, but will provide the information needed to plan a larger study to answer~     that question.~   "
209614|NCT00817167|"~     The study is aimed to evaluate and describe the added value of inReach planning software on~     performance characteristics of standard bronchoscopy.~   "
209615|NCT00817154|"~     The major goal of this project is to adapt an existing group-based psychosocial program to~     enhance community functioning in older people with serious mental illness (SMI). The focus of~     the adaptation is designing and evaluating an individually based rehabilitative program for~     older people with SMI who either cannot or choose not to access a group program.~   "
209616|NCT00817141|"~     Urinary catheter was placed during several days after colonic surgery. Nevertheless, it is~     probably unnecessary after Fast-Track colonic surgery. No prospective data permit to confirm~     it.~   "
209632|NCT00816933|"~     Appendicitis is the most common benign inflammatory disease that requires an operation.~      Laparoscopic appendectomy using three trocar is generally performed, and reveals good~     surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with~     using three trocar, there are some problems including pain around trocar insertion~     sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons,~     more minimal invasive appendectomy is required, with development of laparoscopic~     instrument,eventually one port sppectomy is developed. So, the investigators assess~     post-operative Outcomes according to the Number of Trocar.~   "
209855|NCT00814021|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     kidney cancer that has spread to the brain.~   "
209617|NCT00817128|"~     The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1)~     is very disappointing with chronification, disability and subsequent high medical costs and~     personal suffering. A possible better treatment is intensive function-oriented physical~     therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies~     performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch~     CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or~     Macedonian therapy, is now being adopted on a large scale among physical therapists in The~     Netherlands. There are two level C retrospective cohort studies demonstrating a promising and~     clinical relevant beneficial effect on pain and function after PEPT. In response to the~     growing demand for scientific argumentation among doctors and physical therapists with~     respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen.~     The results of this pilot study were very promising and therefore, we decided to design a~     large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT~     compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines.~   "
209618|NCT00817115|"~     The aim of the proposed study is to compare the exposure dose and diagnostic performance of~     region-of-interest fluoroscopy compared to standard fluoroscopy in patients and~     interventionists during cardiac interventional procedures. It is hypothesized that systematic~     application of x-ray attenuation will significantly reduce the radiation exposure of the~     interventional procedure while maintaining image quality, thereby decreasing risk to the~     patient.~   "
209619|NCT00817102|"~     This study will evaluate the effectiveness of CorCTA by comparing the results of the test~     with another imaging method called Fractional Flow Reserve (FFR), which is done as a part of~     the cardiac catheterization.~   "
209620|NCT00817089|"~     This is a study involving treatment for alcohol dependence among males of European or Asian~     decent. The ultimate aim of this line of investigation is to further establish a genetic link~     between alcohol dependence and treatment by defining an endophenotype associated with~     treatment response. The study will combine two inpatient alcohol challenge sessions along~     with 12 weeks of outpatient treatment using random assignment to either naltrexone or~     placebo.~   "
209621|NCT00817076|"~     The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius)~     syrup in children with allergic skin inflammation. Patients took desloratadine syrup once a~     day for 28 days. Once a week, the doctor measured the patient's symptoms. This measurement is~     called SCORAD. The doctor also rated how much relief the patient got from treatment and~     recorded any side effects.~   "
209622|NCT00817063|"~     The purpose of this study is to investigate the safety and efficacy of alitretinoin in the~     treatment of severe chronic hand eczema that does not respond to treatment with potent~     topical steroids.~   "
209623|NCT00817050|"~     This was a one-day single dose trial conducted to compare patient's preference for Nasonex®~     (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2~     sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take~     one dose of the opposite medication. Questionnaires were given to each patient after each~     drug dose to evaluate patient product preference.~   "
209624|NCT00817037|"~     Patients with chronic kidney disease (CKD) have higher blood pressures than the general~     population. They also tend to have protein leaking into the urine (proteinuria). CKD, high~     blood pressure and proteinuria independently and together increase the risk of developing~     atherosclerosis (hardening) of the arteries that leads to diseases such as heart attack and~     stroke. Although there are a number of drugs available that lower blood pressure, these are~     not always fully effective. Furthermore, there are even fewer drugs that simultaneously lower~     blood pressure, reduce proteinuria, and slow down kidney damage in CKD.~      Recent research has shown that drugs like sitaxsentan not only lower blood pressure but also~     reduce proteinuria and potentially slow down the progression of CKD [1,2]. Before sitaxsentan~     can become freely available to individuals with CKD it is important to look at the effects~     this drug could have on proteinuria and blood pressure.~        1. Goddard J, Johnston NR, Hand MF, et al. Endothelin-A receptor antagonism reduces blood~          pressure and increases renal blood flow in hypertensive patients with chronic renal~          failure: a comparison of selective and combined endothelin receptor blockade.~          Circulation 2004;109:1186-1193.~        2. Krum H, Viskoper RJ, Lacourciere Y et al. The effect of an endothelin receptor~          antagonist, bosentan, on blood pressure in patients with essential hypertension. New~          Engl J Med 1998;338:784-790.~   "
209625|NCT00817024|"~     We conduct this clinical trial to determine the effects of Xuefu Zhuyu capsule (based on TCM~     Zheng Hou theory) in helping recovery from coronary heart disease(CHD)after PCI and find~     out whether this kind of effecacy is much better within patients administered with TCM~     syndrome-based individualized medication.~   "
209626|NCT00817011|"~     The Purpose of this study is to predict antidepressant response in advance using~     pharmacogenomics and peripheral biological markers in depressed patients.~   "
209627|NCT00816998|"~     Hypothesis : Early active range of motion protocol after open reduction and internal fixation~     of a distal radius fracture with a volar fixed angle locking plate results in earlier return~     of functional motion, earlier return to work and improved functional outcomes compared~     delayed mobilization.~      Specific Aim:~      To compare early range of motion versus delayed motion protocol in distal radius fractures~     treated with open reduction and internal fixation with a volar fixed angle locking plate with~     respect to time to fracture union, range of motion, functional outcome measures, return to~     work and complications.~   "
209628|NCT00816985|"~     The purpose of this study is to determine if a less invasive procedure such as liposuction~     can be used to effectively reduce arm lymphedema (swelling of the arm) resulting from breast~     cancer treatment. The standard surgery involves the removal of large portions of skin and~     tissue leaving a large scar. This less invasive procedure (liposuction) uses 3 to 4 tiny~     puncture sites and a vacuum tube leaving minimal scars.~   "
209629|NCT00816972|"~     This was a 1-week study of desloratadine (DL) plus oxybutynin (OXY) at two dose levels in the~     treatment of post-nasal drip in participants with seasonal allergic rhinitis. Participants~     received either desloratadine twice a day, oxybutynin twice a day, desloratadine plus~     lower-dose oxybutynin twice a day, desloratadine plus higher-dose oxybutynin twice a day, or~     placebo for 7 days.~   "
209633|NCT00816920|"~     Whether isolated distal DVT (IDDVT), DVT confined to the calf, should be looked for and~     diagnosed to allow them to be treated with anticoagulants remains one of the still unsolved~     issues in vascular medicine, especially because of the insufficient data on clinical risks of~     untreated distal DVT. Management studies have shown that it is safe to withhold~     anticoagulation in outpatients with suspected DVT if compression ultrasonography (CUS)~     limited to the proximal deep veins yields normal results on presentation and on repeated~     examination after 5 to 7 days. This strategy is based on the premise that IDDVT do not need~     to be diagnosed and treated, what is necessary when they extend involving the proximal veins.~     There is no general agreement, however, on the assumption that the non-extending IDDVT do not~     need to be diagnosed and treated, and many authors recommend to perform a single CUS~     examination extended to the distal deep veins. All the available studies have treated with~     anticoagulants the diagnosed IDDVT and no adequate information is available on the risk of~     IDDVT left untreated.~      The present study, performed in outpatients with suspected leg DVT, aims at assessing the~     clinical consequences of IDDVT diagnosed (by a complete US investigation) but not treated~     because the results of this investigation remain blind to both the patient and the treating~     doctor, whereas the diagnostic-therapeutic procedure remains the usual one, based on CUS~     investigation limited to diagnose proximal DVT, to be repeated after 5-7 days (or earlier) to~     exclude an extension to proximal veins of an IDDVT potentially present.~   "
209634|NCT00816907|"~     This study will test the usefulness of the medication metformin in treating people with~     schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic~     medications.~   "
209635|NCT00816894|"~     A first generation of clinical studies, performed during the last decade, demonstrates that~     adjuvant treatment with compounds that enhance NMDAR-mediated neurotransmission due to their~     agonistic activity at the NMDAR-associated glycine (GLY) site (e.g. GLY, D-serine (DSR))~     leads to significant symptom reductions in chronic schizophrenia patients.Furthermore,~     preliminary findings suggest that treatment with NMDAR-GLY site modulators may also be~     beneficial as antipsychotic monotherapy In the proposed project, during a three year period,~     60 schizophrenia patients that fulfill treatment resistance criteria will be randomly entered~     in a 10 week, two phase (fixed/flexible dose), parallel group, double blind controlled study~     assessing the efficacy of olanzapine (OLA) (up to 40 mg/day) vs. DSR (up to 4000 mg/day) as~     antipsychotic monotherapy.Clinical, neurocognitive, electrophysiological, and amino acids~     (i.e. GLY, DSR) levels assessments will be performed during the study. The specific aims of~     the proposed project are: 1) to assess the efficacy and safety of DSR as a new medication for~     treatment refractory schizophrenia, and 2) to assess DSR effects in terms of relevant amino~     acids serum levels, neurocognitive performance, and relevant brain electrophysiological~     parameters. The overall importance of the proposed project consists of its potential to lay~     the foundations for an innovative type of intervention for treatment resistant schizophrenia~     patients.~   "
209636|NCT00816881|"~     The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus~     clearance devices.~   "
209637|NCT00816868|"~     Because of the effect in the treatment of NSCLC, the capecitabine and erlotinib may compose~     to a new regimen for NSCLC. Based on the preclinical observation and the confirmed clinical~     synergistic anti-tumor activity of combined capecitabine and erlotinib in gemzar refractory~     advanced pancreatic cancer (APC), the investigators previously conducted a phase II study of~     erlotinib in combination with capecitabine against NSCLC.~   "
209638|NCT00816855|"~     The primary objective of this study is to determine the tolerance and overall survival in~     patients with stage Ⅲ NPC treated with neoadjuvant chemotherapy and concurrent~     chemoradiation.~      Secondary objectives of the study are to evaluate the distant metastases free survival, and~     disease-free survival of patients with stage Ⅲ treated with this regimen.~   "
209639|NCT00816842|"~     Citrulline is an amino acid produced in the intestine and in the liver, but the liver does~     not contribute significantly to circulating citrulline concentrations. The intestine is thus~     the only organ that normally releases significant amounts of citrulline into the blood~     stream. The investigators have designed a study looking at the value of measuring plasma~     citrulline concentration in patients with tropical enteropathy of mixed HIV status. The focus~     will be on the ability of the intestine to sustain the individual concerned from a~     nutritional standpoint. The investigators hypothesise that plasma citrulline concentration is~     a marker of small bowel absorptive integrity and an appropriate surrogate for HIV related~     enteropathy.~   "
209640|NCT00816829|"~     Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological~     changes associated with sleep apnea syndrome.~   "
209641|NCT00816816|"~     The primary objective of this study is to determine the tolerance and overall survival in~     patients with stage ⅣAB NPC treated with neoadjuvant chemotherapy and concurrent~     chemoradiation.~      Secondary objectives of the study are to evaluate the distant metastases free survival, and~     disease-free survival of patients with stage ⅣAB treated with this regimen~   "
209642|NCT00816803|"~     This study is designed to assess the safety of autologous bone marrow derived cell transplant~     in chronic spinal cord injury patients. The hypothesis is that the availability of bone~     marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.~   "
209643|NCT00816790|"~     The objective of this study is to determine the feasibility of conducting a large scale~     randomized controlled trial comparing standard and renally adjusted dosage of antibiotics in~     the septic shock patients with acute renal dysfunction. We will use Piperacillin as the~     prototype antibiotic in our study.~   "
209644|NCT00816777|"~     The primary objective of this study is to evaluate the safety and efficacy of Irinotecan Bead~     in combination with intravenous chemotherapy versus intravenous chemotherapy alone in the~     treatment of unresectable liver metastases in patients with colorectal cancer. The results of~     this study are intended to be used in support of a PMA application for a combination device~   "
209645|NCT00816764|"~     This is the first in human study of AGS-8M4 given every 2 weeks to subjects with advanced~     ovarian cancer. AGS-8M4 will be administered as an IV infusion until the disease worsens.~   "
210073|NCT00811174|"~     Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration.~     Octagam 5% is currently registered in more than 60 countries. This study will evaluate the~     efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary~     immunodeficiency diseases.~   "
209646|NCT00816751|"~     The aim of this study is to estimate the efficacy of intracervical versus paracervical block~     on pain experienced during first trimester suction curettage without the use of preoperative~     cervical ripening. Because of the theoretical improved reliability of stromal block, the~     investigators hypothesize that intracervical block would produce lower pain scores than~     paracervical block at the time of cervical dilation.~   "
209647|NCT00816738|"~     To evaluate the clinical outcomes in patients with recurrent corneal erosions who received~     anterior stromal puncture by use of neodymium:yttrium-aluminum-garnet (Nd:YAG) laser.~   "
209648|NCT00816725|"~     The original trial will evaluate the effectiveness of a Web-based program in preventing~     postpartum depression. The site has been modified to provide materials from both conditions.~   "
209649|NCT00816712|"~     This is a study to evaluate the use of fractional synthetic rate as an early biomarker of~     muscle anabolism (muscle build-up).~   "
209650|NCT00816699|"~     Proportion of patients in study group(preprint preoperative anesthetic risk should have more~     anxiety, more knowledge, and more cancellation than controlled group~   "
209651|NCT00816686|"~     This is a first in human study of AGS-16M18 given every week to subjects with advanced renal~     cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days~     until the disease worsens.~   "
209652|NCT00816673|"~     The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow~     Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years~     or more.~   "
209653|NCT00816660|"~     The objectives of this study are to evaluate the immediate tolerability and safety of~     rVWF:rFVIII in subjects with Type 3 Von Willebrand Disease after administration of various~     dosages of VWF:RCo.~   "
209654|NCT00816647|"~     The operative management of chronic patellar instability has been controversial. Medial~     patellofemoral ligament reconstruction has gained success recently and might be superior to~     other soft-tissue procedures. The objective of this prospective study was to compare the~     clinical outcome after medial patellofemoral ligament reconstruction compared with medial~     reefing for chronic patellar instability.~   "
209655|NCT00816634|"~     Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response~     rates, which is most commonly used to treat patients with metastatic, recurrent or locally~     advanced, unresectable squamous cell carcinoma of the esophagus. Because the classical dose~     schedule of this two-drug combination is cisplatin 100 mg/m2 day 1 and 5-FU 1000 mg/m2/day~     continuous infusion for 96-120 hr, prolonged administration time and mucosal toxicity are~     inconvenient to the patients with the aim of palliation. Capecitabine, which is oral prodrug~     of 5-FU and mimic continuously-infused 5-FU, is being investigated in phase I, II and III~     trials for the treatment of gastric, gastroesophageal, and esophageal cancers, primarily in~     the first-line metastatic setting. In our experience, capecitabine plus cisplatin combination~     (XP) as a first-line treatment for 45 patients with advanced or recurrent esophageal squamous~     cell carcinoma demonstrated a promising anti-tumor activity with 57% of response rate and~     showed tolerable toxicity with convenience.~      Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in~     patients with advanced esophageal cancer. A Dutch phase II study demonstrated that paclitaxel~     combination with carboplatin had shown an encouraging confirmed response rate of 59% with 51~     patients with resectable esophageal cancer in neoadjuvant setting. Another Dutch phase II~     study showed 43% of response rate including 4% of CR with 8 months of response duration when~     paclitaxel plus cisplatin administration was given for patients with metastatic esophageal~     cancer. Although recently first-line palliative chemotherapy regimen in esophageal cancer has~     been investigated, many trials have failed to show superiority to 5-FU/cisplatin combination.~     Since we considered that XP or XT is more effective and convenient chemotherapy regimen than~     5-FU/cisplatin, this randomized phase II study was planned to compare XP with XT in terms of~     efficacy and tolerability.~   "
209656|NCT00816621|"~     This study will test the effectiveness of a parent training program aimed at helping children~     who are adopted internationally to develop secure, organized attachments to their parents.~   "
209657|NCT00816608|"~     Hypothesis : The maximum body weight in lifetime is associated with the onset of development~     of type 2 diabetes.~   "
209658|NCT00816595|"~     RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or carry cancer-killing substances to them. It is~     not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more~     effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic~     leukemia or small lymphocytic lymphoma.~      PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin~     and cyclophosphamide together with rituximab with or without bevacizumab and to see how well~     it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic~     lymphoma.~   "
209659|NCT00816582|"~     Purpose:~      To determine whether [18F]FES can predict clinical benefit (defined as complete response,~     partial response and stable disease ≥ 6 months) to fulvestrant (250 mg IM q 28 days) in~     post-menopausal women with recurrent or metastatic ER+ breast cancer who are candidates for~     further hormonal therapy.~   "
209660|NCT00816569|"~     To investigate a possible benefit of Orthokeratology contact lenses to improve uncorrected~     visual acuity of keratoconus patients~   "
209661|NCT00816556|"~     Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The~     main symptoms are dryness, itching and burning in and around the vagina. These symptoms in~     turn can cause pain with intercourse. Other symptoms can include urinary frequency and~     urinary urgency. These symptoms are caused by the decreasing levels of estrogens in~     postmenopausal women.~      The current treatment options include hormone replacement therapy by mouth and patch and~     vaginal creams, tablets and rings. The current guideline recommend using hormone therapy at~     the lowest dose for the shortest time. We are trying to find the lowest effective dose of~     estrogen cream that helps with symptoms without causing an increase in estrogens in the blood~     stream.~      We want to compare two estrogen creams, estradiol and estriol, each at very low doses, with a~     placebo cream. Estradiol cream is available on prescription but we want to see how effective~     it is at one tenth the commonly prescribed dose. Estriol cream is not commonly prescribed and~     is only available at compounding pharmacies. We want to see if either of these estrogens is~     effective at one tenth the usual dose. We also want to see if these creams are effective when~     massaged onto the outer part of the vagina, rather than the usual method of treatment, which~     is inserting them into the vagina.~   "
209993|NCT00812214|"~     It is hypothesized that treating insomnia in migraineurs, many of whom also have tension~     headaches, prolongs total sleep time to the extent that it decreases overall headache~     frequency. Chronic headache sufferers also feel more tired during the day2, undoubtedly~     affecting daytime functioning, which is hypothesized to improve as well with prolonged total~     sleep time.~   "
209662|NCT00816543|"~     The primary objective of this trial is:~        -  To determine whether it is feasible in locally advanced gastric or gastroesophageal~          cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme~          and also to determine what toxicities are involved.~      The secondary objective of this trial are to describe:~        -  The disease free survival at one and two years in that subgroup of patients that has~          undergone a R0 resection.~        -  The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that~          have undergone an R0 resection and progression-free survival and overall survival at one~          and two years.~   "
209663|NCT00816530|"~     Hypothesis: A higher sensitivity to breast cancer detection can be achieved in women with~     dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS)~     and Digital X-Ray Mammography (XRM) together as part of routine screening compared to~     performing and reviewing results of XRM alone.~      Primary Objective: For the cohort of asymptomatic women who have dense breast tissue,~     calculate the sensitivity of Digital X-Ray Mammography (XRM) and ABUS together as a breast~     cancer screening modality and compare it to that of XRM alone.~      Secondary Objective: For the cohort of asymptomatic women who have dense breast tissue,~     evaluate the specificity of XRM and ABUS together compared to that of XRM alone; Calculate~     the negative predictive value (NPV) and positive predictive value (PPV) for XRM and ABUS.~      Endpoint: Breast cancers detected by radiologists in the clinical screening setting and~     confirmed by pathology.~      Study Design: This is a prospective matched-pair clinical study enrolling more than 20,000~     women with parenchymal density > 50% on digital x-ray mammography (XRM). Participants will~     receive ABUS as an adjunct to XRM. Any abnormal findings, from either XRM or ABUS, will~     receive appropriate management action consistent with accepted medical standards of care. All~     evaluation results, diagnosis and treatment outcomes will be recorded. Participants will be~     followed for one year and those who are not diagnosed with breast cancer at enrollment or~     during the follow-up interval must undergo an annual mammogram at study completion, the~     outcome of which will be recorded.~   "
209664|NCT00816517|"~     Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees,~     elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the~     pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting~     neurogenic inflammation.~      Recently, it was reported that patients who suffered from dystonia and had concomitant~     psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of~     their psoriatic lesions.~      This pilot study will determine the safety and efficacy of botulinum toxin in the management~     of psoriasis vulgaris.~   "
209665|NCT00816504|"~     This study is a proof-of-concept clinical study designed to test the hypothesis that oral~     administration of galactose can lower the level of a circulating factor that increases~     glomerular permeability to albumin in patients with resistant FSGS.~   "
209666|NCT00816491|"~     The primary endpoint of the study will be to compare the accuracy of two procedures (FICE~     with target biopsies only, versus conventional white light colonoscopy with recommended~     targeted and random biopsies) in the endoscopic surveillance of patient with long-standing~     UC. Accuracy will be measured based on the number of patients with confirmed neoplasia using~     each technique. The combined histological outcome following the two procedures will represent~     the gold-standard diagnosis for each patient. Secondary outcomes will be the number of~     patients with false-positive findings, the number of neoplastic lesions detected, the number~     of false-positive lesions per patient for each technique and the total time required for each~     procedure.~   "
209667|NCT00816478|"~     This study is a proof-of-concept clinical study designed to test the hypothesis that oral~     administration of galactose can lower the level of a circulating factor that increases~     glomerular permeability to albumin in patients with resistant FSGS.~   "
209668|NCT00816465|"~     This clinical study is designed to evaluate the safety of oral administration of the medical~     food Hoodia to patients with non alcoholic fatty liver disease.~      Oral administration of Hoodia is common in many western world countries for appetite~     suppression and as a food supplement or medical food used for dietary purposes.~      Nonalcoholic steatohepatitis or NASH is a common, often silent liver disease which affects~     about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes~     type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This~     clinical trial has been designed to assess the safety of short term oral administration of~     Hoodia to patients with NASH.~   "
209669|NCT00816452|"~     Patients with prostate cancer treated in outpatient clinics will be recruited by their~     urologist physician.~      Primary Objective: To evaluate the compliance in male patients with prostate cancer treated~     with Bisphosphonate and that suffered from Osteopenia/osteoporosis.~      Secondary objectives:~      To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon~     recommendation by Urologists.~      To evaluate the overall number of patients treated by Bisphosphonate in the out-patient~     clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.~   "
209670|NCT00816439|"~     The cannabinoid type 1 (CB1) receptor is a protein found in the brain that is involved with~     the effects of marijuana; it may also play a role in the effects of alcohol dependence and~     withdrawal. Earlier animal studies have shown that although long-term alcohol use decreases~     the number of CB1 receptors in the brain, the number returns to normal after alcohol use~     stops. This study will use positron emission tomography (PET) and magnetic resonance imaging~     (MRI) scans to trace a radioactive chemical called [11C]MePPEP, which can locate and measure~     the number of CB1 receptors in the brain. Researchers will study the CB1 receptors in the~     brains of people with alcohol dependence, and compare the results to the CB1 receptors in the~     brains of people without alcohol dependence. The results of this study will be used to~     further research into appropriate treatment procedures for alcohol dependence.~      This study will include 30 men with alcohol dependence and 50 men without alcohol dependence.~     All of the men must be between 18 and 65 years of age. Participants in both groups must not~     have any medical conditions that will prevent them from undergoing PET or MRI scans.~      For the PET scan, participants will be injected with a small amount of [11C]MePPEP and will~     then be brought to the PET scanner. The scan will take between 3 and 4 hours, but~     participants will be allowed to take breaks over the course of the scan. The MRI scan will~     not require any injections and will take approximately 1 hour to complete.~      Participants without alcohol dependence will make three visits to the National Institutes of~     Health Clinical Center. Blood and urine samples will be taken during one visit, and~     participants will arrange to have an MRI scan on one visit and a PET scan on the other visit,~     in whichever order they prefer.~      Participants with alcohol dependence will undergo two PET scans: the first will be performed~     between 3 and 7 days after the participant last consumed alcohol, and the second will be~     performed approximately 2 to 4 weeks after the first scan (with no alcohol consumption~     permitted in the interval). Participants will alcohol dependence will also undergo an MRI~     scan and will provide blood and urine samples.~   "
209994|NCT00812201|"~     This study will collect data on a new feature for future heart failure devices via an~     external non-implantable system.~   "
209995|NCT00812188|"~     Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.~   "
209671|NCT00816426|"~     This study, conducted jointly by researchers at the National Masan TB Hospital, Asan and~     Samsung Medical Centers in Seoul, Republic of Korea, and the Yonsei University and the NIH in~     the United States, will examine why some patients with tuberculosis (TB) develop disease that~     is harder to treat than most cases. TB is an infection of the lung that usually can be~     successfully treated with anti-TB drugs. However, some people get a more serious kind of~     disease (called multi-drug resistant TB or extensively drug-resistant TB) that is very~     difficult to treat and may not be cured by the regular medicines available. This study will~     try to find out if some of the common TB drugs are getting to the place where the TB bacteria~     are. It will also look at how current anti-TB drugs might be used more effectively and how~     better drugs might be developed.~      People 20 years of age and older with hard-to-treat TB who have elected to undergo surgical~     removal of part of their lung at the National Masan Tuberculosis Hospital, Masan, the Asan~     Medical Center, and the Samsung Medical Center, may be eligible for this study.~      Participants undergo the following procedures:~        -  Medical history and physical examination, including sputum sample.~        -  Blood tests at various times during the study.~        -  Drug administration. Subjects are given one dose each of five common TB drugs~          rifampicin, isoniazid, pyrazinamide, kanamycin and moxifloxacin before they undergo~          surgery to remove part of their lung. After surgery, some of the lung tissue and fluid~          around the lungs that was removed during surgery will be examined to determine the~          regions where the TB bacteria live and analyze the lung tissue itself.~        -  Dynamic MRI (magnetic resonance imaging) scan. This type of scan uses a magnetic field~          and radio waves to produce pictures of the lung. Subjects lie very still on a table~          inside the cylindrical scanner with their head on a soft cradle and their hands over~          their head. Several images are obtained for less than 5 minutes at a time.~   "
209672|NCT00816413|"~     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor~     peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop~     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Removing the T cells from the donor cells~     before transplant and giving cyclosporine and mycophenolate mofetil after transplant may stop~     this from happening.~      PURPOSE: This phase I/II trial is studying the side effects of giving a donor stem cell~     transplant after pentostatin and total-body irradiation and to see how well it works in~     treating patients with hematological cancer.~   "
209673|NCT00816400|"~     Evaluate the safety, tolerability and the tolerated maximum dose of MEDI-575 in adult~     subjects with advanced solid tumors refractory to standard therapy or for which no standard~     therapy exists.~   "
209674|NCT00816387|"~     The purpose of this study is to evaluate the efficacy of fallopian sperm perfusion (FSP) in~     comparison with standard intrauterine insemination (IUI) in natural cycle for couples with~     unexplained infertility or mild male factor.~   "
209675|NCT00816374|"~     The purpose of the investigators' study is to find the best way to provide information about~     sun protection and skin cancer detection. The investigators want to see which of two methods~     most improves sun protection and screening attitudes and practices. The investigators hope to~     improve these attitudes and practices among people who are at higher risk for melanoma.~     People at higher risk for melanoma are first degree relatives (mother, father, sibling or~     child) of people diagnosed with melanoma.~   "
209676|NCT00816361|"~     Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors~     refractory to standard therapy or for which no standard therapy exists.~   "
209677|NCT00816348|"~     This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to~     infants and children with parenteral nutrition-associated liver disease to enable reversal of~     elevated serum liver enzymes and direct bilirubin (cholestasis).~   "
209678|NCT00816335|"~     The purpose of this pilot study is to evaluate a combined and integrated technological~     approach of 18F-FDG-directed perioperative PET/CT imaging and intraoperative handheld gamma~     probe detection of known and occult disease in patients undergoing surgery for solid~     malignancies.~   "
209679|NCT00816322|"~     The whole study was divided into two major parts: (A) the 12-week, double-blind, randomized~     controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to~     moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel~     omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in~     recovery status.~      The goals of this study were to examine the therapeutic and recurrence prevention effects of~     omega-3 fatty acids on major depressive disorder.~   "
209680|NCT00816309|"~     Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent~     chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is~     thought to improve cough and help clear the airways of sticky sputum. Traditionally,~     physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece,~     called the Acapella device) has been developed to make physiotherapy practise easier. This~     study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients~     with severe bronchiectasis.~   "
209681|NCT00816296|"~     The goal of this study is to investigate comparisons between the intestinal microbiome in~     patients with obesity and in patients with obesity and Non-Alcoholic Fatty Liver Disease~     (NAFLD). With this protocol we hope to better understand how the microbiome of each~     individual works with disease progression.~   "
209682|NCT00816283|"~     RATIONALE: Dasatinib and vorinostat may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Giving dasatinib together with vorinostat may kill more~     cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib when~     given together with vorinostat in treating patients with accelerated phase or blastic phase~     chronic myelogenous leukemia or acute lymphoblastic leukemia.~   "
209683|NCT00816270|"~     The aim of this randomized and masked prospective trial is to compare the effectiveness of~     Liquid Bandage (Octyl-2-Cyanoacrylate) and 6/0 nylon suture as a wound closure device in~     upper lid blepharoplasty surgery.~   "
209768|NCT00815165|"~     Cytomegalovirus (CMV) is an important cause of illness and occasional deaths in infants who~     catch the virus before they are born, in newborns, and in children and adults who have weak~     immune systems. The purpose of this study is to look at how the CMV vaccine works in the~     blood. This study is being done along with the main CMV gB/MF59 vaccine study that looks at~     how the overall body reacts to the vaccine. Participants will include up to 100 healthy~     adolescent female subjects aged 12 to 17 years who were vaccinated in study 04-039 and 100~     subjects that were screened for 04-039 to participate as controls. Study procedures will~     include up to 6 blood draws taken over a 13 month period. Participation will be about 31~     months (unless the patient enrolls into the shedding study).~   "
209684|NCT00816257|"~     All patients enrolled in the registry will be recipients of single and double lung~     transplantation (bilateral sequential, heart-lung, or living related donor grafts). During~     the routine management of lung recipients frequent surveillance of the lung allograft is~     necessary. This routinely involves: measurement of pulmonary functions, chest radiography,~     collection of peripheral blood to assess other organ function and monitor therapeutic drug~     levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung~     tissue biopsy. This surveillance normally follows a set schedule during the first one to two~     years following the transplant procedure. Surveillance is routinely performed at weeks 2, 8,~     12, 24, 36, and 52 during the first year following the transplant procedure. Additional~     surveillance may be performed at any time when clinically indicated for the optimal~     management of the recipient. Information and specimens collected from each of these~     encounters will be entered in the data registry and specimen repository.~   "
209685|NCT00816244|"~     The purpose of this study is to monitor:~        -  Tumor biological alterations following two weeks of neo-adjuvant statin therapy.~        -  Effects of statins on tumor proliferation.~        -  Functional studies on the mevalonate pathway.~   "
209686|NCT00816231|"~     The purpose of this study is to determine how people react to different combinations of~     alcohol and nicotine.~   "
209687|NCT00816218|"~     This project is designed to evaluate the molecular mechanisms involved in the early~     development of endothelial dysfunction in type 2 diabetic patients. The investigators intend~     to correlate increases in insulin signaling pathway activity following pioglitazone therapy~     with improvements in nitric oxide synthase expression in skeletal muscle. In addition, the~     investigators will evaluate vascular responses and in vivo nitric oxide release during~     administration of acetylcholine and nitroprusside in patients with type 2 diabetes. Enhanced~     knowledge of the molecular mechanisms responsible for endothelial dysfunction, an early~     abnormality in the pathogenesis of atherosclerosis, is critical before novel therapies to~     arrest or delay the appearance of cardiovascular complications in diabetes can be developed.~      The investigators intend to recruit fifty type 2 diabetic patients treated with diet alone or~     diet plus sulfonylureas or meglitinides and add Pioglitazone (45 mg), an insulin sensitizer,~     for 6 months. In addition to assessment of clinical and metabolic parameters, insulin~     sensitivity and brachial artery and skin microcirculatory responses to acetylcholine and~     nitroprusside in combination with simultaneous determination of nitric oxide release will be~     documented before, 3 and 6 months after Pioglitazone therapy is initiated. Circulating levels~     of markers of endothelial damage (VCAM, ICAM, selectins), inflammation (C-reactive protein~     and interleukins), increased coagulability (PAI-1) as well as lipids and apolipoproteins will~     measured during the study. Skeletal muscle biopsies will be performed during the euglycemic~     insulin clamp before and 6 months after therapy for measurements of NO synthase activity and~     key elements of the insulin signal transduction pathway involved in the regulation of glucose~     metabolism (IRS-1, PI-3 kinase, PI-3 kinase associated with IRS-1 and the mitogenesis~     MAP-kinase.~      Type 2 diabetes confers a substantial increase in the risk of cardiovascular disease. This is~     believed to be due, in part, to endothelial dysfunction, which correlates closely with~     impaired vascular responsiveness. Our study will clarify further the extent to which~     resistance to insulin action and impaired nitric oxide release from endothelial cells are~     interrelated. We also expect to demonstrate that insulin sensitizers (pioglitazone) can help~     to restore normal endothelial function, and ultimately prevent/delay the appearance of~     vascular disease in patients with type 2 diabetes.~   "
209688|NCT00816205|"~     This is an open label, dose-finding study. Approximately 8 healthy subjects will be~     participating in this study.~      Within one week after the screening visit, subjects who meet all inclusion criteria and none~     of the exclusion criteria will enter a one day treatment period. During this period, 4 anal~     manometric studies will take place. Study medication (Coated Nifedipine suppositories at~     various doses) will be administered at pre-determined intervals. During the study, blood~     samples will be obtained for plasma Nifedipine analysis.~   "
209689|NCT00816192|"~     There is no study comparing safety/efficacy of externally vs internally cooled tip catheters~     in patients undergoing ablation for paroxysmal atrial fibrillation (pAF).~      The primary objective is to compare safety and efficacy of externally irrigated-tip catheter~     versus internally irrigated-tip catheter in achieving long term electrical isolation (EI) of~     pulmonary veins (PV) in paroxysmalatrial fibrillation (pAF).~   "
209690|NCT00816179|"~     This study is being done to find out if an endoscope passed down the throat, through the~     stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the~     abdomen and take biopsies if needed.~   "
209691|NCT00816166|"~     The main objective of this study is to prospectively evaluate the safety, probable benefit,~     and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter,~     randomized clinical trial.~      A secondary objective of this study is to evaluate the impact of stenting in the~     neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of~     stay, charges, and costs.~   "
209692|NCT00816153|"~     Pleth Variability Index (PVI) seems to be an ideal parameter to guide fluid management:~     dynamic parameter and non-invasive. PVI could guide fluid management during surgery and~     optimization of the plethysmographic-derived parameter could improve hemodynamics of the~     patients.~   "
209693|NCT00816140|"~     Clarithromycin-based triple therapy containing a proton-pump inhibitor (PPI) twice daily,~     amoxicillin 1g twice daily, and clarithromycin 500 mg twice daily for 7 days is one of the~     standard firs-line therapy for Helicobacter pylori eradication. However, because of~     unsatisfactory eradication rate (80-85%), the Maastricht III guideline recommended extending~     the treatment duration to increase the eradication rate. Recently, levofloxacin (500 mg~     qd)-based triple therapy has been shown to achieve an eradication rate of 90% for both the~     first- and second-line treatment for H. pylori eradication. Several studies have demonstrated~     that high dose (750mg) and short-course (5 days) levofloxacin is as effective and well~     tolerated as traditional dose (500mg) and course (10 days) for treatment of mild-to-severe~     community acquired pneumonia. The high dose and short-course therapy has the potential to~     increase patient compliance and reduce bacterial resistance to fluoroquinolones. However,~     whether increasing the dosage of levofloxacin from 500mg to 750 mg qd can augment the~     efficacy of triple therapy in eradication of H. pylori and shorten the duration of therapy~     remains unknown. Although levofloxacin-based regimen was presumed to be more effective,~     previous reports pointed the concern that resistance to fluoroquinolone and other antibiotics~     which susceptible to the pumping efflux of bacteriae would increase among the gut flora.~   "
209694|NCT00816127|"~     The purpose of this study is to investigate how effective and cost saving~     1-deamino-8-D-arginine vasopressin (desmopressin, DDAVP) is as opposed to the transfusion of~     blood products in preventing bleeding after teeth extraction in persons with severe liver~     disease being evaluated for liver transplant.~   "
209783|NCT00814970|"~     To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of~     de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA)~     and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease~     (PAD).~   "
228914|NCT00560703|"~     To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of~     patients who have both blepharitis and facial rosacea~   "
209695|NCT00816114|"~     In this study researchers propose to do a chart review of all patients that are treated~     outside of a clinical trial with imatinib, dasatinib, nilotinib, or any other tyrosine kinase~     inhibitor that becomes FDA approved for the managements of CML that come to MDACC for a~     second opinion. This is an important population of patients that differs in their management~     from patients treated in clinical trials for several reasons including but not limited to:~        1. It represents a very large patient population receiving standard-dose therapy with TKI.~          We estimate that we have evaluated over 300 patients that fall in this category.~        2. The follow-up for patients in the largest trial using standard-dose imatinib (the IRIS~          trial, with 553 patients in treated with imatinib) has been limited after the first 12~          months. For example, the rate of molecular responses after the first 12 months of~          therapy was not obtained as samples stopped being collected at that time point.~        3. Registration studies for dasatinib and nilotinib have similar limitations with limited~          follow-up and available information coming only from databases from the sponsors to~          which there is limited access to investigate dosing, chronic toxicities, second~          malignancies and other important aspects of therapy.~        4. Patients who are or become pregnant during therapy with TKI have not been eligible for~          clinical trials with TKI or had to be taken off study. Thus, there is no information on~          the effect of TKI on imatinib on pregnancy and conception. We have followed several such~          patients at MDACC.~        5. This is a patient population that follows therapy mostly as directed by their local~          oncologists. This is frequently less stringently adhered to the recommended guidelines~          for TKI therapy, with more frequent treatment interruptions, and frequently using~          suboptimal doses of imatinib (i.e., less than 300mg daily). The effect of these~          treatment interruptions and suboptimal dosing on response and development of resistance~          is unclear.~      Researchers plan to conduct a chart review of these patients to study their treatment course~     before their initial evaluation at MDACC, and between and during visits to MDACC.~   "
209696|NCT00816101|"~     The purpose of this pilot clinical study is to compare healing rates, pain levels, and~     incidence of wound complications including infection with the use of a moist PROCELLERA™~     Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite,~     following curettage and electrodesiccation of skin lesions.~   "
209697|NCT00816088|"~     Fungal infections caused by Aspergillus fumigatus are now identified in up to 45% of patients~     dying from haematological malignancy. There has been a significant increase in deaths from IA~     over the last 20 years. Our current diagnostic approach is neither sensitive nor specific.~     The purpose of this study is to prospectively assess the value of current diagnostic tools,~     as well as test other new diagnostic methods for the diagnosis of IA among haemato-oncology~     patients undergoing chemotherapy or stem cell transplantation.~   "
209698|NCT00816075|"~     The purpose of this study is to compare and evaluate the efficacy of distilled water vs~     Mitomycin C on preventing the recurrences of intermediate risk group recurrent superficial~     bladder cancer administered as a single dose immediate instillation after complete~     Transurethral Resection(TUR) of the tumor.~   "
209699|NCT00816062|"~     The purpose of this study is to examine, through the endpoints established in this protocol,~     the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a~     post-approval environment.~   "
209700|NCT00816049|"~     The purpose of this study is to increase the fraction of patients, who become MRD-negative~     during consolidation for the non-HR ALL group through individualized intensification of the~     6MP-dosage days 30-85.~   "
209701|NCT00816036|"~     The primary objective of this study is to determine whether a nurse-initiated intervention,~     which couples brief inpatient counseling and proactive telephone counseling by a centralized~     tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. If proven~     effective, the proposed intervention will provide a practical strategy to enhance the~     adoption and implementation of recommended smoking cessation procedures in VA hospitals, and~     will demonstrate the utility of quitlines in preventing relapse in hospitalized smokers once~     they leave the hospital.~   "
209702|NCT00816023|"~     The purpose of this study is to assess the efficacy and identify the optimal dose(s) of~     ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery~     including the use of cardio pulmonary bypass.~   "
209703|NCT00816010|"~     Hypothesis To investigate whether telephone counselling by nurse educator between clinic~     visits with particular emphasis on adherence to medications and lifestyle modification in~     patients with coronary heart disease and diabetes will reduce mortality and hospitalisation~     rates due to cardiovascular events compared to usual clinic-based care.~   "
209704|NCT00815997|"~     To investigate the advantage of using a 4Fr guiding catheter over a 6 Fr, frequencies of~     radial artery occlusion after transradial coronary intervention (TRI) will be evaluated.~     Radial artery occlusion rate in 4 Fr TRI group is expected to be not more than that in 6Fr~     groups.~   "
209705|NCT00815984|"~     In about 800 children with allergic diseases (asthma, allergic rhinitis, atopic dermatitis)~     the investigators will retrospectively and cross-sectionally analyze the~     influence/correlation of diagnosis, treatment methods, allergy status (skin prick test~     results), lung function tests results on/with the concentration of nitric oxide in exhaled~     breath.~   "
209706|NCT00815971|"~     Recently it has been suggested that specific mutations in the EGFR gene in lung cancer~     patients is associated with response to a novel drug targeting the EGF system. Recent~     research also indicates that there is a possible association to the degree of aggressiveness~     of the disease.~      The importance of these mutations is controversial, because the data are based on small~     studies with highly selected patients.~      In this project the investigators want to study the types and frequencies of EGFR mutations~     in both untreated and treated patients in a systematic manner and relate this to survival.~      The thorough registration of patient data in DK enables us to create a strong The~     investigators expect this knowledge to be of greatest importance for future rational use of~     drugs targeting the EGF receptors.~   "
209707|NCT00815958|"~     The embolisation of fat and bone marrow during long bone instrumentation is a well-known~     complication of major joint replacement surgery. Clinically significant venous thromboembolic~     disease, cardiopulmonary dysfunction,cerebral emboli, and death have all been described.~     Because the intravasation of medullary contents is caused by increased pressure during canal~     instrumentation, the use of the Synthes RIA (Reamer-Irrigator-Aspirator), a negative~     pressure-irrigated high-speed reamer, may result in a lower incidence of embolism.~      This controlled clinical trial will evaluate the utility of the RIA in reducing the frequency~     and severity of embolic events as detected by intraoperative transesophageal echocardiography~     (TEE) and transcranial Doppler (TCD) during total knee arthroplasty (TKA) surgery.~   "
209784|NCT00814957|"~     The purpose of this study is to investigate the relationship between the plasma~     concentrations of the study drug and the amount of the study drug bound to the D3 receptors~     of the brain after dosing of a new compound GSK618334.~   "
209785|NCT00814944|"~     The purpose of this study is to determine the safety and efficacy of an ocular sirolimus~     (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE~     Model.~   "
209708|NCT00815945|"~     Uterine sarcomas account for less than 5% of all carcinomas of the uterine corpus. The~     prognosis of these patients is extremely limited. Recurrence rates of 50-60% are reported~     even for early-stage disease (FIGO I/II). Median overall survival is below 12 months in~     patients with advanced or metastatic disease.~      Ovarian carcinosarcoma is extremely rare among ovarian malignancies (< 2%). That is why there~     is insufficient data as a basis for establishing a gold standard. As a result, these cases~     tend to be treated in the same way as uterine sarcomas or epithelial ovarian malignancies in~     clinical practice.~      On the basis of data published to date on the treatment of mixed mesenchymal-epithelial~     tumors, it is clear that the treatments commonly used to date have limited activity while~     producing clinically relevant toxicity. The regimes verified so far (Cisplatin / Ifosfamide,~     Ifosfamide/Paclitaxel and Gemcitabine/Docetaxel) exhibit a considerable side effect spectrum~     and are only rarely feasible on clinical everyday life conditions, so e. g. the rate of~     withdrawals due to toxicity was in a study collective of selected females treated with the~     last combination at 40 %. The physician has to check in every individual case if one of the~     above mentioned combinations is feasible. The search for alternative effective and better~     tolerated treatment options is essential. The toxicity data on the carboplatin-PLD~     combination are known, and efficacy has been identified in small cohorts.~      The objective of this study is to explore the efficacy of combination PLD-carboplatin~     treatment in a larger patient population.~   "
209709|NCT00815932|"~     This is a controlled trial designed to determine short- and long-term effects of repeated~     tDCS on the P300 component of event-related evoked potentials in patients with chronic~     neuropathic pain due to Complex regional Pain Syndrome (CRPS) or diabetic neuropathy as~     compared with healthy subjects.~   "
209710|NCT00815919|"~     The purpose of this research study is to determine the effectiveness of bortezomib (Velcade)~     plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this~     drug combination in this patient population. Chronic GVHD is a medical condition that may~     occur after allogeneic stem cell transplantation. The donor's immune system may recognize the~     participants body (the host) as foreign and attempt to reject it. Bortezomib has been used~     in other research studies, and information from those studies suggests that this drug may~     help to control the abnormal immune responses that underlie cGVHD.~   "
209711|NCT00815906|"~     The purpose of this study is to evaluate the safety and tolerability of single doses of~     SBI-087 in Japanese subjects with rheumatoid arthritis.~   "
209712|NCT00815893|"~     The objective of this study is to evaluate the feasibility of dexmedetomidine infusion for~     oral cancer patients undergoing awake fiberoptic nasal intubation. We hypothesized that a~     loading dose of intravenous dexmedetomidine before awake fiberoptic nasal intubation for oral~     cancer patients undergoing general anesthesia will provide adequate sedation and analgesia~     without respiratory depression and upper airway obstruction.~   "
209713|NCT00815880|"~     The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for~     the treatment of heart failure. The product is designed to help reduce the symptoms of heart~     failure and help patients function better with daily activities. The study evaluates multiple~     measures of heart function and whether the patient's quality of life has been improved since~     the device implant. The patient will have several visits after the device implant to assess~     how well they are doing and to monitor any safety concerns.~   "
209714|NCT00815867|"~     Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular~     filtration rate estimated 30 days after kidney transplant.~   "
209715|NCT00815854|"~     This study will examine possible causes of metabolic side effects in people taking atypical~     antipsychotic (AAP) medications.~   "
209716|NCT00815841|"~     Background: There is a paucity of data as to the effect of methylphenidate (MPH) on young~     adults who do not have attention deficit hyperactivity disorder (ADHD). The existing data is~     equivocal and focuses on neuropsychological functions that are not always relevant to the~     clinical aspects of attention. Objective: To determine the effect of MPH on a diagnostic~     continuous performance task that assesses attention per se (TOVA) and on a decision making~     test (Modified Gamble Decision Test) in young, healthy adults. Methods: Fifty young adults,~     men and women ages 20-30, without ADHD, learning disabilities, history of past or present use~     of MPH or other psychotropic drugs, will be eligible to participate. Design: The experiment~     will be conducted in 2 sessions, the first lasting 3.5 hours and the second 2.5 hours in a~     randomized, double-blind prospective design. In the first session, the subjects will be~     screened for ADHD past and present, major psychiatric diagnosis (depression, anxiety, etc),~     use of MPH in the past, psychotropic medications or recreational drugs and any other chronic~     illness; urine will be tested for beta-hCG to rule out pregnancy. Blood pressure and heart~     rate will be measured. The participants will then be given either placebo or MPH (15-20 mg)~     and after 90 minutes will proceed to complete the TOVA (that lasts 22 minutes) and Modified~     Gamble-Decision Test (15 minutes). Before taking the pill and prior to the testing, the~     subjects will complete the Visual Analogue Scale (VAS) which quantifies their subjective~     feelings regarding present mental and emotional state. In the second session, 2 weeks later,~     blood pressure and heart will be measured and the VAS completed prior to and 90 minutes after~     taking the tablet. The subjects then undergo the TOVA and Modified Gamble-Decision Test. Data~     Analysis: will be performed using the paired t-tests for parametric variables and one way~     ANOVA with repeated measurements. Significance: Results of this study are important since MPH~     is used and abused by healthy students as a study aid although its objective effects in~     normal young adults are not well delineated~   "
209717|NCT00815828|"~     The object of this study is to evaluate patients with a diagnosis of GD who are included in a~     program of RE carried out with rubber tubes, comparing the frequency of women who will use~     insulin in the group who will participate in the program with the group that won't do the~     exercises, and to verify the impact of the program on the adequacy of capillary glycemic~     control of the pregnant women.~   "
209718|NCT00815815|"~     This study will examine the effectiveness of inpatient treatment for anorexia nervosa versus~     a sequenced treatment that transitions from higher intensity inpatient care to lower~     intensity outpatient care.~   "
209719|NCT00815802|"~     Direct DNA amplification, viral isolation and specific antibody measurement in saliva~        1. From children in day care centers (samples collection will take place during a single~          week)~        2. From children coming at the emergency department of our hospital during a three months~          period.~      Sample collection will be done by the pediatrician the nurse, or one of the authorized~     investigators of the study.~   "
209786|NCT00814931|"~     The purpose of this study is to assess the effects of CXB722 on neuroendocrine stress~     response and subjective reports related to mood and stress during and after experimentally~     induced stress among healthy young males.~   "
209787|NCT00814918|"~     The goal of this study is to compare how efficient two different types of PDTs are when used~     in combination with topical 5-ALA. The two types of PDT lights are Blu-U light and Candela~     V-beam Pulse Dye Laser.~   "
209720|NCT00815789|"~     The goal of this study is to improve cardiovascular disease (CVD) and cholesterol in African~     Americans adults with diabetes by addressing the modifiable risk factors of systolic blood~     pressure (SBP), glycosylated hemoglobin (Hb A1c), and low-density lipoprotein cholesterol~     (LDL-C). We will evaluate the impact of a tailored CVD risk management intervention~     administered by nurses via the telephone. The intervention incorporates medication management~     and behavioral modification and will be tailored to the needs of vulnerable high risk~     subjects (e.g. African Americans, low socioeconomic status, low literate). It will be~     integrated into community clinics, thereby enhancing the potential for benefit and~     generalizability to other settings.~      The primary hypothesis is that among African American subjects with diabetes, a nurse~     administered, tailored cardiovascular risk management intervention targeting both medication~     management and behavioral patient self-management will decrease SBP by 5 mmHg, Hb A1c by~     0.5%, and LDL-C by 20 mg/dl over 12 months relative to the cardiovascular education-only~     control group.~   "
209721|NCT00815776|"~     The purpose of this study is to characterize the safety profile and assess the effectiveness~     of the CID in treating subjects with temporomandibular disorders (TMDs). This study is an~     open-label, three arm, randomized, unblinded clinical trial with a pre-treatment screening~     phase, a baseline visit and a 3 month treatment or exercise phase.~   "
209722|NCT00815763|"~     The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd~     for acute ischemic stroke.~   "
209723|NCT00815750|"~     There are two parts to this study: (1) an information gathering phase leading to development~     of a new decision aid (phase 1); and (2) a study to test the newly developed decision aid~     (phase 2).~   "
209724|NCT00815737|"~     This study will determine if rhubarb will reduced the incidence of pneumonia and improved~     recovery from an acute cerebral hemorrhage. The study is designed to look at both infection~     rate and overall recovery and recovery of motor function, for example muscle strength and~     coordination.~   "
209725|NCT00815724|"~     The National Heart, Lung, and Blood Institute (NHLBI) has established guidelines for treating~     people with asthma. This study will evaluate the effectiveness of a distance learning program~     that aims to educate doctors on these guidelines, specifically the use of inhaled~     corticosteroids to treat asthma in pediatric patients.~   "
209726|NCT00815711|"~     To establish a registry of patients for future studies of Inflammation in Interstitial Lung~     Disease/Idiopathic Pulmonary Fibrosis.~   "
209727|NCT00815698|"~     The investigators want to evaluate the effect of suturing the mesh versus using a~     self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.~   "
209728|NCT00815685|"~     The data collected through this pilot study will allow us to increase our understanding of~     cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our~     long-term goal is to improve nutritional treatment and reduce illness in the cancer patient~     population.~   "
209729|NCT00815672|"~     The purpose of this study is to gain a better understanding of the mechanisms responsible for~     cancer-related fatigue.~   "
209730|NCT00815659|"~     The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid~     profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol,~     triglyceride) in patients with metabolic syndrome.~   "
209731|NCT00815646|"~     Immersion pulmonary edema (IPE) is a condition in which fluid fills the lungs during diving~     or swimming, particularly in cold water. Some individuals appear to be predisposed to~     developing IPE. DNA samples will be collected and stored, in order to compare the genetic~     profiles of individuals who have experienced IPE with those who have not. In a few~     individuals who have experienced IPE, we plan to measure the effects of cold water immersion~     on the blood pressure, cardiac output and the pressures in the pulmonary artery. These will~     be compared with similar measurements already obtained from normal individuals.~   "
209732|NCT00815633|"~     The purpose of this study is to determine whether the biologic medication alefacept (Amevive)~     is effective and safe in the treatment of Pityriasis Rubra Pilaris.~   "
209733|NCT00815620|"~     A prospective observational study containing three arms comprising different therapeutic~     measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms~     include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor~     radiotherapy.~   "
209734|NCT00815607|"~     The purpose of this study is to test the safety of an investigational combination~     drug/immunotherapy for the treatment of Stage III/IV melanoma.~   "
209735|NCT00815594|"~     The occurrence of conjunctival scarring finally leads to the obstruction of the fistula tract~     created by the filtering surgery. Vascular endothelial growth factor is thought to be a key~     role in the formation of conjunctival scar, which play a pivotal role in the wound-healing~     process. So it seems that the recombinant human anti-VEGF antibody could inhibit~     angiogenesis, and reduce the conjunctival vascular formation in the wound-healing process~     after glaucoma filtering surgery.~   "
209736|NCT00815581|"~     Screening of refractory defect is one of major reason for amblyopy. Photorefraction is a new~     method with some advantages in treatment of this problem. In this study the investigators are~     going to compare the results of this surgery in children between 1 to 10 years old with~     cycloautorefraction in children above 3 years old.~   "
209737|NCT00815568|"~     The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total~     body irradiation, fludarabine, and busulfan conditioning.~   "
209738|NCT00815555|"~     The aim of the study is to examine whether tamoxifen-treated Israeli breast cancer patients~     who are CYP2D6 poor metabolizers (CYP2D6*4/*4 genotype) are at higher cancer relapse risk~     during 2.5-5-year follow-up period from initial diagnosis and primary treatment.~   "
209739|NCT00815542|"~     When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common~     practice is to induce labor. Whenever the cervix is not ripened, there are several methods to~     ripen the cervix, two of which are: mechanical, using a double balloon catheter and~     pharmacological, with prostaglandins. The aim of the study is to compare those two methods of~     cervical ripening for patients with significant oligohydramnion at term.~      The study will be a prospective randomised trial.~   "
209796|NCT00814801|"~     The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day~     and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment~     of patients with Alzheimer's disease.~   "
209740|NCT00815529|"~     This research is planned to build a basis about effect of acupuncture for chronic low back~     pain with economical efficacy.~      It is consisted with two sub research. First,clinical research to know the effect of~     acupuncture for chronic low back pain will be processed with acclate, randomized, patient,~     outcome-assessor masking. 130 subjects would be collected and devided into two~     groups(Experimental and placebo). Experimental group will undergo with real acupunture~     treatment twice a week, for 6 weeks and acupuncture spots would be selected for each person~     by clinical specialist. Placebo group will undergo with Park-sham needle and same 8~     acupuncture spots would be used for all subjects also twice a week, for 6 weeks. The effect~     will be accessed by VAS, x-ray, ODI, SF-36, EQ-5D, BDI before and the last treatments.~      Second is qualitative research to make a basis through the economic evaluation and~     satisfaction of acupuncture treatment for chronic low back pain. 15 persons who have been~     treated at oriental medical hospital for chronic low back pain and 15 in experimental group~     and 15 in placebo group who participate the clinical research will be collected and through~     the personal interview, satisfaction about the treatment and economic efficacy will be~     evaluated.~   "
209741|NCT00815516|"~     The study will evaluate how effective and how safe the drug micafungin is when compared to~     the drug amphotericin B deoxycholate in treating neonates and young infants with certain~     fungal infections.~   "
209742|NCT00815503|"~     Pain treatment after periacetabular osteotomy is traditionally based on systemic opioids wich~     have side effects. The purpose of this study is to evaluate the analgetic effect of wound~     infiltration with local anaesthesia after periacetabular osteotomy.~   "
209743|NCT00815490|"~     A cerebral oximeter is a device that uses light to measure the amount of oxygen within the~     brain. It is similar to the device that measures the level of oxygen in the tip of the~     finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the~     forehead that both emits and detects the amount of light absorbed. This study will determine~     how accurate the device is by comparing the displayed value on the monitor with blood samples~     taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In~     order to test the device over a suitable range, the level of oxygen within the blood will be~     reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the~     equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy~     volunteers.~   "
209744|NCT00815477|"~     I-START is a randomized controlled trial that will evaluate the efficacy of an internet-based~     program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with~     hypertension. I-START will be evaluated using objective outcome indices: systolic and~     diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (HR) modulation and~     baroreflex sensitivity. The Heart and Stroke Foundation of Canada Blood Pressure Action~     Plan(TM) (BPAP) will be adminisered over a 4-month period, and evaluated in a 2~     (Intervention vs. Wait list Control) X 2 (Baseline vs. Post-Intervention) factorial design,~     blocking for 3 recruitment sites (Toronto, London, the Grey Bruce region of Ontario, Canada),~     and stratified for sex and age group (45-59, 60-74 years).~   "
209745|NCT00815464|"~     Study Purpose:~      The purpose of this study is to assess that Liquid Acupuncture(Herb Acupoints Injection)~     Therapeutics could achieve permanent efficacy response in Chronic Hepatitis B.~      Efficacy Assessment:~      At cessation of the Treatment(about at 24 weeks)comparing Testing Data with the Normal~     Criteria and their individual baseline.Continue for monitoring the Status 1-5 years.~      Data Analysis:~      Each 4 weeks collecting Patients' testing data and fill a table.A summary table will be~     presented as frequency tables for categorical variables as number or percentage.~   "
209746|NCT00815451|"~     This study aims to investigate the effect of polyphenol-rich dark chocolate (DC) on insulin~     resistance, adiponectin , blood pressure (BP), lipid profile in obese subjects and determine~     possible associations between all assessed parameters.~      It hypothesizes that consumption of polyphenol-rich Dc could lower fasting glucose levels,~     insulin resistance and improve BP, total cholesterol, low-density lipoprotein (LDL) and~     triglycerides while increasing adiponectin and high-density lipoprotein (HDL) in overweight~     or obese individuals.~   "
209747|NCT00815438|"~     Surgical removal of the gallbladder is needed in 1 million people per year in the USA. The~     procedure is done by placing four tubes (cannula) from 5 to 10 mm through the abdominal wall.~     Air is placed in the abdominal cavity and a lighted scope is placed through one cannula. The~     space in the abdominal cavity can then be seen on a video screen. Thin retractors and~     dissecting instruments are placed through the other cannula and the gallbladder is removed~     using the video screen for vision. The gallbladder duct and the artery are usually occluded~     with clips or stitches.~      In this study we propose to do the procedure though a single 5 mm incision placed at the~     umbilicus and a second access through the vagina using a flexible endoscope. The gallbladder~     will be retracted using strings (sutures) attached to the gallbladder. The dissection will be~     done using laparoscopic instruments (scissors, knives, dissectors) placed through the~     laparoscopic port. A flexible grasper may be used in the endoscope to help with retraction.~     An endoscopic snare or grasper will be used to grasp the gallbladder and remove it from the~     abdomen through the vagina.~      This study evaluates the ability to do laparoscopic cholecystectomy with one skin incision~     and one vaginal incision. This will provide the basis for future studies evaluating decreased~     pain and costs with transvaginal assisted cholecystectomy.~   "
209748|NCT00815425|"~     Rheumatoid arthritis (RA) is a long-term autoimmune disease that is characterized by pain,~     stiffness, inflammation, swelling, and sometimes destruction of joints. RA usually requires~     lifelong treatment, including medications, physical therapy, exercise, education, and~     possibly surgery, but the course and severity of the disease can differ significantly from~     person to person. The purpose of this study is to identify genetic and other factors that~     determine the severity of RA in African Americans.~   "
209749|NCT00815412|"~     A 3-year, randomized, controlled trial comparing a traditional worksite health promotion~     program and an activated consumer program on health practices, health status and patient~     activation measures.~   "
209797|NCT00814788|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such~     as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they~     work compared with bicalutamide in treating patients with recurrent or metastatic prostate~     cancer.~   "
209750|NCT00815399|"~     Type 2 diabetes is an epidemic. Its long-term consequences translate into enormous human~     suffering and economic costs; however, much of the morbidity associated with long-term~     microvascular and neuropathic complications can be substantially reduced by interventions~     that achieve glucose levels close to the nondiabetic range. However, none of the recent~     intervention studies has demonstrated a benefit of intensive glycemic control on their~     primary CVD outcomes.~      The investigators report the findings of a long-term randomized and comparator-controlled~     clinical trial conducted in patients with newly-diagnosed type 2 diabetes. The investigators~     compared the effect of pioglitazone with that of metformin on circulating endothelial~     cell-derived submicroscopic membranous vesicles, termed microparticles: because of their~     putative role in inflammatory processes and their ability to directly affect endothelial~     functions, they are gaining increasing popularity as a surrogate marker of cardiovascular~     outlook. Metformin was chosen as a comparator because the American Diabetes Association~     recommendations suggest to start therapy in newly-diagnosed type 2 diabetic subjects~     combining a drug (metformin) with lifestyle changes. Moreover, the mechanism of action of~     pioglitazone is distinct from that of metformin.~   "
209751|NCT00815386|"~     Improvement in heart failure with moderate to severe mitral regurgitation using a~     percutaneously delivered implantable device residing in the coronary sinus~   "
209752|NCT00815373|"~     Both Cosopt® and Xalatan® plus Timoptic® will significantly lower IOP, however only Cosopt®~     will demonstrate positive hemodynamic effects. The clinical significance of this will be~     investigated by examining the ophthalmic and short posterior ciliary arteries to determine~     the blood supply to the optic nerve head, the site of damage in glaucoma~   "
209753|NCT00815360|"~     To investigate the role of ranibizumab and angiographically-directed peripheral scatter laser~     therapy in patients with clinically-significant diabetic macular edema (CSME) and peripheral~     nonperfusion. We propose a novel treatment of CSME in a subgroup of patients defined by a~     combination of ultrawide-field angiography (UWFA) and optical coherence tomography (OCT).~     Within this classification scheme, patients with CSME are subdivided by the presence of: 1)~     focal macular leakage, 2) vitreomacular interface traction, and/or 3) peripheral~     nonperfusion. The successful treatment of diabetic macular edema would be dictated by~     pathophysiology-directed therapy based on this classification.~      The subgroup of interest for this clinical trial is characterized by diabetic macular edema,~     peripheral nonperfusion on UWFA, and the absence of macular traction on OCT. This group of~     patients has previously not been well recognized or characterized due to limitations in~     previous, standard angiographic evaluation of the retinal periphery.~      We postulate that this subcategory represents one with a high rate of failure of accepted~     therapies given persistence of the basic pathophysiologic mechanism for CSME, namely~     ischemia-induced production of Vascular Endothelial Growth Factor (VEGF) from the retinal~     periphery. This also represents a population of patients with likely recurrence of CSME~     despite treatment with anti-VEGF therapy alone for the same reason.~   "
209754|NCT00815347|"~     Hypothesis: The endothelin-1 receptor antagonist, bosentan when added to the treatment of~     asthma patients who are symptomatic despite the use of controller therapy will improve asthma~     symptoms and physiology.~      Twenty patients with a diagnosis of asthma, between the ages of 21 and 70 who are symptomatic~     despite the use of at least one controller medication will be randomized to either placebo or~     active medication for an 8 week period (initial 4 weeks is at 1/2 of final dose as per~     package insert and FDA approval). Measures of lung function and symptoms will be recorded.~     Patients will then cross over, so that patients initially on placebo will receive active drug~     for 8 weeks and those initially on active drug will receive placebo. The same endpoints will~     be measured. The acute bronchodilator effects of the drug will also be tested on the first~     day of therapy at the full therapeutic dose.~   "
209755|NCT00815334|"~     Endoscopic subureteral injection for vesicoureteral reflux has become an established~     alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be~     also a primary treatment option for VUR in adults. However, the experience with ESI in adults~     who have VUR associated with decreased bladder compliance is limited. We evaluated the~     efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults~     with decreased bladder compliance.~   "
209756|NCT00815321|"~     This is an extension of our ongoing clinical trial using ex vivo expanded autologous~     Cytokine-induced killer (CIK) cells as an adoptive cellular immunotherapy for haematological~     malignancies. The pre-existing clinical trial targets patient with acute myeloid leukemia or~     MDS, and relapsed disease post allogeneic transplant.~      Chronic myeloid leukemia (CML) is a disease with good response to kinase inhibitors. There~     are however patients in transformed phase of the disease who do not respond to these~     treatment. A small proportion of patients with response to Imatinib may develop mutations~     resulting in drug resistance. In addition, the vast majority of patients with a good response~     to the kinase inhibitors still have persistent CML cells detectable at a molecular level. It~     is known that the CML progenitors are not sensitive to the kinase inhibitors. On the other~     hand, immune mediated mechanism is known to be able to eradicate CML as shown by efficacy of~     donor lymphocyte infusion in the allogeneic transplant setting. Early clinical trials have~     shown clearance of bcr-abl using peptide vaccination. There is also convincing mouse data~     showing eradication of CML at molecular level by autologous CIK cells, but no clinical trial~     has been done using CIK cells for CML.~      We therefore plan to expand our current CIK trial to include CML as a disease, for CML~     patients with various degree of response to the kinase inhibitors which have already offered~     its maximal effect. We aim to study whether autologous CIK cells may further improve disease~     response, either in the eradiation of minimal residual disease, or in conjunction with~     chemotherapy for control of high tumour load disease.~   "
209757|NCT00815308|"~     The purpose of this study is to determine whether the treatment of locally advanced~     esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel,~     cisplatin and radiation improve clinical outcomes.~   "
209758|NCT00815295|"~     In this Phase I B/II trial, we seek to determine the safety and efficacy of sorafenib with~     standard dose cetuximab in the treatment of patients with Recurrent and /or Metastatic~     Squamous Cell Carcinoma of the Head and Neck (SCCHN).~   "
209798|NCT00814775|"~     The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach~     Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients~     where this may be difficult.~   "
209759|NCT00815282|"~     In the Netherlands, the human Papillomavirus (HPV) vaccination will be added to the National~     Vaccination Program for girls to protect against the development of cervical cancer. The~     vaccine protects against HPV type 16 & 18, which cause about 75% of cervical cancer. Studies~     have shown that the vaccine is effective in healthy subjects in preventing infection by HPV~     16 & 18. However, no evidence exists on the immunogenicity and safety of HPV vaccination in~     patients with an immune system disorder, such as primary humoral immunodeficiency (i.e.~     hypogammaglobulinemia) or autoimmune diseases. Concerns exist that vaccination may cause an~     aggravation of the underlying disease. In addition, the immune response to vaccination may be~     diminished due to immunosuppressive therapy or the underlying disease.~      Objective: The primary goal of the current study is to study the immunogenicity of HPV~     vaccination in patients with an autoimmune disease and a primary humoral immunodeficiency.~      Based on retrospective analysis with other vaccines we hypothesize that patients with~     autoimmune diseases who are under immunosuppressive medication and patients with a immune~     system disorder have a decreased serological response to HPV vaccination, and that the~     produced HPV antibodies titers decrease more rapidly than in healthy individuals.~      The secondary objective is to explore safety of HPV vaccination and immune regulatory~     mechanisms induced by vaccination in a subset of patients. The investigators hypothesize that~     HPV vaccination is safe and that HPV-induced regulatory T cells are able to prevent an~     increase in the activity of an autoimmune disease.~   "
209760|NCT00815269|"~     Previous studies on animals suggest that inhalational anesthetics can reduce vascular tension~     in vitro resulting in vasodilation and decrease in blood pressure. This role for inhalational~     anesthetics has essential clinical implications such as the condition of sepsis or septic~     shock or other shock-associated states during which the blood vessel constricts strongly and~     leads to circulation dysfunction. The vasodilation property of these anesthetics including~     halothane, isoflurane, sevoflurane, desflurane and enflurane enables them to be better~     options than other general anesthetics in many clinical conditions needing the vasculature to~     be dilated. The investigators hypothesized that these inhalational anesthetics can evoke~     vasodilation measured with ultrasonography during general anesthesia in vivo as the in vitro~     studies displayed.~   "
209761|NCT00815256|"~     The purpose of this study is to evaluate the effectiveness of collagen cross linking (CXL) in~     reducing progression of mild and moderate progressive keratoconus.~   "
209762|NCT00815243|"~     The purpose of this study is to determine whether telemedicine consultations (lead by~     standard scheme)allows to increase quality of anatomical and functional outcomes and improve~     clinical work-flow at patients with acute bone and joint trauma, hip pathology and congenital~     orthopedics abnormalities.~   "
209763|NCT00815230|"~     The clinically widely used X-ray computed tomography examination has a low-grade radiation~     effect and recently has attracted much attention concerning the possible adverse effects of~     radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells~     mainly because it can interact with water (which makes up to 80% of cells) to generate~     reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we~     can reach, there is no report concerning the relation between X-ray computed tomography~     examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if~     the cardiac computed tomography angiography (cardiac CTA) may induce a higher level of ROS in~     the peripheral blood.~      Study subjects will be OPD patients who are arranged for cardiac CTA examination because of~     suspect coronary artery disease (CAD). In total, twenty cases will be enrolled for the study.~     The formal consent will be delivered and explained to the patients and families after the~     arrangement of cardiac CTA. It then will be retrieved just before the performance of cardiac~     CTA.~      For each enrolled case, peripheral blood will be sampled three times (once before and twice~     after the performance of cardiac CTA). Totally 60 blood samples will be collected from 20~     study subjects within 3 months (January 1 ~ March 31, 2009). ROS level in the collected blood~     samples will be then measured, compared, and analyzed.~   "
209764|NCT00815217|"~     A prospective, single blinded randomized clinical study will be performed to determine if the~     injection of lipoaspirate into diabetic or venous stasis wounds promotes wound healing or~     wound closure at a faster rate than conventional treatment.~   "
209765|NCT00815204|"~     Approximately, post-traumatic stress disorder (PTSD) occurs in 8% of the adult population~     over time. Exposure to traumatic events increases the risk of poor physical health and often~     leads to disability. The biology of PTSD is continually being explored in order to help find~     better treatments for this debilitating disorder. In our study, we propose to further our~     understanding of PTSD. Prior research has found that patients with PTSD have changes in the~     stress hormone pathway. In this pathway, there is release of certain hormones from the~     pituitary gland in the brain that feed into the blood stream and tell the adrenal gland to~     produce stress hormones.~      The pituitary is a gland located at the base of the brain which controls the hormones in the~     body, including the stress hormones. Research in other psychiatric disorders has found~     changes in the pituitary volume along with changes in the hormones. This has not been~     investigated yet in PTSD. Therefore, we propose in our study to measure pituitary volume in~     people with PTSD and look at the changes in the stress hormone pathway. Moreover, we will~     investigate whether other hormones are affected by PTSD. In this way, we can further our~     understanding of the the biology of PTSD and help develop new therapies which can intervene~     through the hormonal system.~   "
209766|NCT00815191|"~     The primary objective of this study is to determine if the intraoperative distal esophageal~     (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in~     patients undergoing open colectomy under general anesthesia. This is a randomized study.~   "
209767|NCT00815178|"~     The purpose of the study is to determine if inspiratory muscle training improves inspiratory~     muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.~   "
209799|NCT00814762|"~     The purpose of this research study is to evaluate the safety of GSK Biologicals'~     investigational HIV vaccine 732461, administered as two doses approximately 1 month apart, in~     a small group of HIV infected people.~   "
209800|NCT00814749|"~     To test the value of preoperatively performed urodynamics with regard to outcome of surgery~     for stress urinary incontinence (SUI) and to examine whether not performing urodynamics~     preoperatively is more cost effective than performing urodynamics preoperatively using the~     non-inferiority assumption.~   "
209769|NCT00815152|"~     1. Purpose and Objective:~           To determine the feasibility and short- and long-term efficacy of an empirically-based~          CST intervention (Keefe et al.) with caregivers of patients with primary malignant brain~          cancer.~        2. Study Activities and Population Group:~           The target sample will be 20 caregiver-patient dyads. Using a randomized controlled,~          prospective design, potentially eligible participants will be identified at the time of~          initial consultation (see Figure 1). Outcomes will be assessed at baseline,~          post-intervention (3 months post-randomization), 6 months post-randomization, and every~          4 months up to 2-years in the event that the patient dies.~        3. Data Analysis and Risk/Safety Issues:~      With only 10 subjects per group we do not have statistical power for direct hypothesis~     testing. Nevertheless, p-values will be presented for some analyses (chi-square tests,~     t-tests, and Spearman correlations) simply to aid in interpretation of results. In no way~     will these p-values be used to declare statistical significance or non-significance of the~     test results. Accordingly, the primary focus will be the means, variances, and covariances of~     the study endpoints, as well as the change scores in these endpoints across the study~     intervention and their 95% confidence limits.~   "
209770|NCT00815139|"~     Neointimal coverage over stent strut is important for preventing the stent thrombosis. But,~     there is no data for the duration of complete formation of neointima om zotarolimus eluting~     stent (ZES). Previously the investigational observational data at 9 months showed most of~     stent strut was covered with neointima. Therefore, the investigators investigated the~     evaluation of neointimal coverage on 3 months after ZES implantation using novel OCT system,~     which is powerful intravascular imaging system having the higher resolution power.~   "
209771|NCT00815126|"~     This study aims to compare the efficacy of nasal provocation test with~     Lysine-Acetylsalicylate in patients with history of NSAIDs hypersensitivity between~     mucocutaneous symptoms and respiratory symptoms and laboratory outcomes.~   "
209772|NCT00815113|"~     Introduction: Gastric cancer is the world's second largest cause of cancer related deaths. In~     the Western world, as well as in Israel, this malignancy is less prevalent than colorectal~     cancer, but has higher morbidity and mortality. First degree relatives of patients with~     gastric cancer have a 1.5-fold to 3-fold increased risk of developing gastric cancer~     themselves. In relatives of gastric cancer patients who are also carriers of a CagA positive~     strain of Helicobacter pylori, the risk is 8-fold. Mucosal atrophy, hypochlorhydria, high~     lymphoid follicle density, pan gastritis, and interleukin 1 β polymorphism are frequent in~     family members of gastric cancer patients and are associated with increased risk of the~     disease.~      Aims:~        1. To characterize the high risk individual for gastric cancer development.~        2. To establish a screening plan for early detection and prevention of gastric cancer in~          first degree relatives of gastric cancer patients.~        3. To validate new procedures for assessing risk factors for development of gastric cancer:~          gastric acid output, gastric mucin output, serum levels of pepsinogen I, pepsinogen II,~          gastrin B12, Helicobacter pylori status [serology, histology, urease test, 13C-urea~          breath test (13C-UBT)].~        4. To assess genetic changes in the gastric mucosa of the screenees in comparison with~          gastric cancer patients and controls.~      Methods:~      We will approach 50 gastric cancer patients treated in Rabin Medical Center, and ask for~     their consent to approach first degree relatives for participating in the study. For each~     gastric cancer patient 4 relatives will be asked to signed an informed consent and undergo~     the study procedures. For each participant a matched control for age, sex and background~     diseases, out of consecutive gastro esophageal reflux disease (GERD) patients undergoing~     gastroscopy, will be asked to join the study. Thus, we will screen 50 gastric cancer~     patients, 200 first degree relatives of gastric cancer patients, and 200 controls.~   "
209773|NCT00815100|"~     The purpose of this study is to investigate whether a pure heart rate-lowering agent~     (Ivabradine) reduces vascular inflammatory stress in patients with acute coronary syndromes~   "
209774|NCT00815087|"~     The purpose of this study is to determine whether functional electrical stimulation is~     effective in the treatment of dysphagia due to nasopharyngeal cancer post radiotherapy~   "
209775|NCT00815074|"~     The purpose of this study is to gain better understanding of how recently deployed military~     women managed urinary and vaginal symptoms while deployed. Participants in this study will be~     asked to take part in a 45-60 minute interview.~   "
209776|NCT00815061|"~     The aim of the present study was to describe the incidence and prevalence of IBD in non~     Jewish Israel population~   "
209777|NCT00815048|"~     The investigators hypothesize that the use of a combination of Atropine and Remifentanil will~     safely facilitate non emergent intubation procedure as effectively as the protocol of~     Atropine, Fentanyl, and Succinylcholine.~   "
209778|NCT00815035|"~     Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is~     to produce a new treatment that would benefit subjects who have peanut allergy by lowering~     the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune~     response in subjects who have peanut allergy (tolerance).~   "
209779|NCT00815022|"~     Several factors influence the extension of anesthetic mixture during spinal anesthesia~     including anesthetic gravity, body position, drug volume, and drug-delivering velocity.~     However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is~     hitherto unknown. The investigators hypothesized that different temperatures of the~     anesthetic mixture had different velocity of extension after spinal anesthesia. In addition,~     previous studies suggest that parturients have relative higher sensitivity to temperature.~     Herein the investigators proposed that the temperature of anesthetic mixture had more~     extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean~     delivery.~   "
209780|NCT00815009|"~     Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet~     will have a greater effect on slowing disease progression and reversing hepatic steatosis~     and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to~     a regular healthy diet alone.~   "
209781|NCT00814996|"~     There are two research purposes of this study. One is to explore which psychosocial issue or~     biological issue would affect the social function among people with schizophrenia. The other~     one is to explore which social function would affect the job tenure among people with~     schizophrenia. There are 60 participants diagnosed with schizophrenia and divided into two~     groups, employment and unemployment. we will use several social function tests to collect~     social function, PANSS to evaluate their psychotic symptoms. And then we will compare and~     analysis the data through statistic software. Finally, we will have he answer about how~     social skills affect the social function and which social skill would affect the job tenure~     among people with schizophrenia.~   "
209782|NCT00814983|"~     The primary objectives will be to measure the safety and efficacy of allogeneic stem cell~     transplantation using a peripheral blood stem cell graft that has been depleted of CD45RA+~     Naive T-cells.~      The secondary objectives will be to measure the pace of immune recovery.~   "
209801|NCT00814736|"~     To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors~     UK369,003 and sildenafil~   "
209788|NCT00814905|"~     Chorioamnionitis occurs in 1% to 5% of term pregnancies and may complicate up to 25% of cases~     of preterm labor. The traditional regimen used to treat intra-amniotic infection is~     intravenous ampicillin 2g every 6 hours and intravenous gentamicin 1.5 mg/kg every 8 hrs~     until delivery . In the past the recommendation has been that the antibiotics be continued~     postpartum until 24-48 hours afebrile. More recent studies have looked at using a one time~     dose of antibiotics after delivery vs treating until 24-48 hours afebrile. There have been no~     studies comparing treatment of chorioamnionitis with antibiotics vs no treatment with~     antibiotics postpartum. The aim of this study is to compare no treatment vs treatment with~     one dose after a vaginal delivery and one dose of antibiotics vs a full course until 24 hours~     afebrile after a cesarean delivery complicated by chorioamnionitis. The hypothesis is that~     there will be no difference in outcome between the two groups in each arm. This is a~     randomized study. Once the patient delivers she will be randomized to one of two groups in~     each arm. First arm (vaginal delivery) A: no treatment, B: treatment with a one time dose of~     ampicillin/gentamicin; Second arm (c/s) A: one dose of ampicillin/gentamicin/clindamycin, B:~     treatment with ampicillin/gentamicin and clindamycin until 24 hours afebrile. The goal of the~     study is to determine the optimal postpartum management of chorioamnionitis.~   "
209789|NCT00814892|"~     RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an~     effective immune response to kill tumor cells. It is not yet known which vaccine is more~     effective in treating patients with prostate cancer.~      PURPOSE: This phase II trial is studying how well the combination of a proven effective~     allogenic whole prostate carcinoma cell (APCC) vaccine co-administered with ex vivo generated~     dendritic cells (DCs)(DC-APCC) extend the time to prostate cancer progression.~   "
209790|NCT00814879|"~     This pilot study will provide data on the safety and efficacy of the combination of~     Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced~     subjects that have a suppressed HIV viral load on a Ritonavir (RTV) boosted Protease~     Inhibitor (PI) based regimen who are then switched to a regimen of RAL 400mg BID +ATV 300mg~     BID.~   "
209791|NCT00814866|"~     Osteoclastic bone resorption depends on both the capacity to generate osteoclasts~     (osteoclastogenesis) and on individual osteoclast activity. The investigators objective is to~     study the effect of anti-TNF therapy on the number of osteoclast precursors in the peripheral~     blood of patients with Rheumatoid Arthritis, on in vitro osteoclastogenesis and on osteoclast~     activity before and during the treatment of patients with Rheumatoid Arthritis with~     Adalimumab.~   "
209792|NCT00814853|"~     Neurally adjusted ventilatory assist (NAVA) is a FDA approved mode of mechanical ventilation.~     This mode of ventilation is currently in routine use in adult, pediatric and neonatal~     intensive care units. The electrical activity of the diaphragm, the largest muscle used~     during respiration, is measured. The ventilator applies support in proportion to the measured~     electrical activity of the diaphragm (Edi). This electrical activity is measured through a~     feeding tube that also has a multiple-array esophageal electrode in it.~      Whenever a patient gets extubated in our MSICU, we conduct a routine extubation readiness~     test. This is standard of care in our ICU. If the patient fails this test, the patient stays~     on the ventilator. If he passes, he gets extubated. We wish to conduct a study during which~     we will monitor the electrical activity of the diaphragm during this test. If the patient~     passes the extubation readiness test, the study is complete. If he fails, he resumes on the~     ventilator. In our study, we would then use the measured signal of the diaphragm to guide the~     ventilator. This mode of ventilation is called NAVA. We do not currently use this mode of~     ventilation in the ICU, but could do so since it is FDA approved. However, we wish to use~     this protocol to gain more expertise with this mode of ventilation in the ICU in a controlled~     fashion. We wish to enroll 20 pediatric patients. Patients in the ICU are routinely on a~     variety of different models of ventilators. Usually, the respiratory therapist determines~     which ventilator will be used. All patients in this study would be on the Servo-I ventilator,~     which is an FDA approved ventilator and capable of monitoring electrical activity of the~     diaphragm and currently used in our MSICU.~   "
209793|NCT00814840|"~     The purpose of this study is to assess the efficiency of permanent biventricular pacing using~     three ventricular leads in terms of reduction in adverse cardiac events rates, improvement in~     cardiac capacity and patients' functional status in subjects with congestive heart failure~     and a physiologic (sinus) rhythm.~   "
209794|NCT00814827|"~     Opportunistic infections are caused by bacteria, mycobacteria, fungi or viruses that do not~     normally cause infections in people with healthy immune systems. Some of these infections can~     cause public health concerns, especially in areas with limited access to treatment. People~     who acquire opportunistic infections usually have diseases that affect their immune systems,~     such as human immunodeficiency virus (HIV), or do not have enough white blood cells to fight~     the infection. However, some people acquire opportunistic infections even though they have~     normal amounts of white blood cells and are free from known diseases that harm their immune~     systems. This study will investigate some of the reasons that otherwise healthy people get~     opportunistic infections to learn more about why some people are more likely to have them.~      This study will include up to 210 HIV-negative males and females older than 18 years of age~     who have opportunistic infections. The patients will be drawn from multiple sites in Thailand~     and Taiwan including Khon Kaen University Hospital, Siriraj Hospital, Ramathibodi Hospital,~     National Taiwan University Hospital, National Cheng-Kung University Hospital~      Patients will undergo an initial evaluation that will include a physical examination, medical~     history, and blood and urine testing. Additional tests will be conducted if the researchers~     consider that the tests are medically necessary to treat the opportunistic infection; the~     results of the tests will be reviewed and saved for study purposes. Depending on the severity~     of the infection, the initial evaluation may take more than 1 day to complete.~      After the evaluation, patients will be given standard and appropriate medicines to treat the~     infections.~      Patients will return for follow-up visits to allow researchers to monitor their condition and~     to assess how well the patient is responding to the treatment. Patients will be evaluated by~     the study researchers at least once a year for 2 years following the initial treatment.~   "
209795|NCT00814814|"~     Management of cardiac arrest is complicated by the lack of a readily available tool~     identifying individuals who are likely to be successfully resuscitated. S100 beta is a~     protein that originates in the astroglial cells of the brain, and NSE (Neuron Specific~     Enolase) is another protein that originates in the neurons themselves. In the laboratory, the~     concentration of these proteins correlate with evidence of brain damage after head trauma,~     stroke and exposure to low levels of oxygen. The concentration of these proteins in the blood~     of human survivors of cardiopulmonary resuscitation in humans is much higher than in patients~     who were resuscitated but did not survive. However, it is still unclear whether survivors~     from cardiopulmonary resuscitation have higher levels of these proteins in their blood if~     they survive with neurological injury secondary to the arrest and resuscitation.~      Hypothesis: In humans, the blood concentrations of protein S100 beta and NSE during and after~     resuscitation can predict who will die despite cardiopulmonary resuscitation and who will~     survive with neurological injury secondary to the arrest and resuscitation.~   "
209802|NCT00814723|"~     Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often~     have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an~     evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients~     with primary hypercholesterolemia where the combination therapy with statins~     (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should~     be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total~     cholesterol levels compared to monotherapy.~   "
209803|NCT00814710|"~     The purpose of this study is to assess the immunogenicity in terms of antibody response and~     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse~     events following primary vaccination of Indian infants with pneumococcal conjugate vaccine~     GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined~     vaccine during the first 4 months of life. The study will be conducted in India.~   "
209804|NCT00814697|"~     The investigators wish to investigate the efficacy of targeted repetitive transcranial~     magnetic stimulation (rTMS) on expressive language in patients with Alzheimer's disease (AD).~     In rTMS, magnetic pulses are used to noninvasively stimulate focal areas of cortex of about a~     square centimeter in area. rTMS has been approved in the United States for the diagnosis of~     peripheral nerve conditions.~      Depending on the frequency of stimulation, rTMS can preferentially stimulate or inhibit~     cortical areas. In stroke rehabilitation, for example, inhibition of the contralateral,~     uninvolved hemisphere by low frequency rTMS has improved movement of the affected limbs~     because of less aberrant inhibition of the affected hemisphere by the healthy hemisphere. The~     effects of rTMS has also been investigated and found to be useful in treating refractory~     depression and depression in Parkinson's disease. In addition, rTMS has improved naming in~     patients with Alzheimer's disease and has improved cognitive abilities and memory in~     non-demented older adults. Two studies found that rTMS improved aphasia in patients with~     stroke. While these studies are small, a review of the literature suggests that there may be~     a beneficial role for rTMS in patients with chronic neurological conditions. In addition,~     rTMS appears to be well tolerated, with transient headaches being the most common side~     effect.~      In this small open label study, the investigators wish to investigate the usefulness of~     bilateral stimulation of the brain region termed the dorsolateral prefrontal cortex (DLPFC)~     in patients with AD who have naming and language deficits.~   "
209805|NCT00814671|"~     The goal of this Phase 2 study is to determine the microbiological activity and safety of~     rifapentine when given as a component of multidrug intensive phase treatment of~     smear-positive pulmonary tuberculosis (TB).~      Funding Source- FDA Office of Orphan Products Development (OOPD)~   "
209806|NCT00814658|"~     The purpose of this study is to evaluate the combination of galantamine with nimodipine in~     patients with mixed dementia on cognition and quality of life.~   "
209807|NCT00814645|"~     This study is designed to investigate the safety and tolerability of AIR001 Inhalation~     Solution when administered under conditions of hypoxia and to identify dose levels of drug~     resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.~   "
209808|NCT00814632|"~     Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or~     pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of~     these factors may include altered immune response, infections, altered vaginal acid-base~     balance, allergic reactions and psychosexual disorders. Women are generally treated with~     medications such as anti-histamines, anti-depressants and anti-inflammatories, or with~     physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents~     (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral~     medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided~     imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often~     ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is~     utilized as a last resort.~   "
209809|NCT00814619|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus~     thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses~     over a shorter period of time, may kill more tumor cells and have fewer side effects.~     Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. It is not yet known whether giving~     capecitabine together with 3-D conformal radiation therapy is more effective with or without~     panitumumab in treating patients with advanced rectal cancer.~      PURPOSE: This randomized phase II trial is studying giving capecitabine together with~     radiation therapy to see how well it works with or without panitumumab in treating patients~     with advanced rectal cancer.~   "
209810|NCT00814606|"~     This study seeks to evaluate the safety and efficacy of taking fluvastatin along with~     peginterferon alfa in previous partial responders with genotype 1 HCV.~   "
209811|NCT00814593|"~     RATIONALE: Biological therapies, such as lymphokine-activated killer cells, may stimulate the~     immune system in different ways and stop tumor cells from growing. Drugs used in~     chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. It is not yet known~     whether lymphokine-activated killer cells are more effective than Gliadel wafer in treating~     patients with glioblastoma multiforme.~      PURPOSE: This randomized phase II trial is studying the side effects and how well~     lymphokine-activated killer cells work compared with Gliadel wafer in treating patients with~     newly diagnosed glioblastoma multiforme that can be removed by surgery.~   "
209812|NCT00814580|"~     The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone~     IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.~   "
209813|NCT00814567|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known~     whether intensity-modulated radiation therapy is more effective than standard radiation~     therapy in treating patients with early-stage breast cancer.~      PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating~     women with early-stage breast cancer who have undergone breast-conservation surgery.~   "
209815|NCT00814541|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as doxorubicin and dexamethasone,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) together~     with bortezomib may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin~     and dexamethasone works in treating patients with multiple myeloma that has relapsed or not~     responded to treatment.~      PATIENT POPULATION: Patients with relapsed or refractory multiple myeloma requiring therapy~     will be invited to participate in this study. Eligible patients will be >18 years old and~     able to give fully informed consent. Patients must have a Performance Score (PS) of 0-3~     (ECOG), measurable serum and/or urine paraprotein, or serum free light chain, bilirubin value~     of less than one and a half times the upper limit of normal with ALT/AST values less than two~     and a half times the upper limit of normal. Patients with non-secretory multiple myeloma are~     excluded from this study.~   "
209816|NCT00814528|"~     The purpose of this study is to compare the treatment of skin growths called actinic~     keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other~     conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil~     (5-FU).~   "
209817|NCT00814515|"~     A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007~     (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to~     Severe Dry Eye Syndrome~   "
209818|NCT00814502|"~     The purpose of this research study is to compare the effectiveness of Zolpidem CR to that of~     placebo in improving sleep efficiency in people with dementia admitted to the hospital~     because of their symptoms. You can participate in this study if you have dementia of the~     Alzheimer's type or vascular dementia. This study involves placebo; a placebo is a tablet~     that looks exactly like Zolpidem CR, the study drug, but contains no active study drug. We~     will use placebos to see if the study results are due to the study drug or due to other~     reasons. Zolpidem CR is also called Ambien CR and is widely available by prescription.~     Zolpidem CR is approved by the U.S. Food and Drug Administration (FDA) for the short-term~     treatment of insomnia (trouble falling or staying asleep).~   "
209819|NCT00814489|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2~     formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in~     young adults. Subjects will be vaccinated 2 times in an observer-blind manner with an~     interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third~     dose of the vaccine at Month 6. The protocol posting has been updated following a protocol~     amendment.~   "
209820|NCT00814476|"~     Randomized, two arms, controlled, open study comprised of two consecutive segments. At the~     first segment that will last during the first 4 months of the study, patients will be~     randomized to the Care link treated group or non Care link treated group. At this segment of~     the study the usage of the Care link system will be accompanied by the diabetic team, through~     at least monthly contact via the Internet initiated by the diabetic team. At the second~     segment of the study, during the following 4 months, both groups will use the Care link~     System, home-use, without support initiated by the diabetic team.~   "
209821|NCT00814463|"~     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill~     any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating~     patients with brain metastases.~   "
209822|NCT00814450|"~     This study is intended to provide clinical data regarding safety and accuracy of the~     ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.~   "
209823|NCT00814437|"~     The aim of this project is to study the physiological role of the KiSS-1/GPR54 system in the~     granulosa cells of the human ovary.~   "
209824|NCT00814424|"~     The study hypothesis is that a modified smart bite block system can deliver up to 10~     liters/minute of supplemental oxygen orally with the CO2 monitoring performance substantially~     equivalent to the currently marketed smart bite block that delivers oxygen up to 5~     liters/minute~   "
209825|NCT00814411|"~     This study uses a randomized, noninferiority design to determine whether group family~     planning counseling is as effective as individual family planning counseling among~     gynecological patients with unmet need at two teaching hospitals in Ghana.~   "
209826|NCT00814398|"~     The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo~     transfer in good prognosis patient.~   "
209827|NCT00814385|"~     This study focuses on pre-pandemic priming of man against H5 influenza with the goal of~     mounting a robust antibody response to small quantities of vaccine either before or during an~     H5 pandemic.~   "
209828|NCT00814372|"~     To define the relative efficacy, safety and tolerability profiles of oral daily MBX-102 at~     daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8~     weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable~     dose of metformin (≥ 1500 mg/day).~   "
209829|NCT00814359|"~     Radiation treatment is very effective for treating cancers of the head and neck, however,~     during the course of treatment, it is common for patients to experience soreness of their~     mouth and throat due to the radiation. When radiation causes inflammation of the inside of~     the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to~     prevent and treat mucositis, but none of these have been shown to be superior to another.~     This study is being conducted to see if using a combination of magic mouthwash and sucralfate~     is better than using a single mouthwash called benzydamine at decreasing the burden of~     mucositis.~   "
209830|NCT00814346|"~     The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on~     cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild~     Alzheimer's disease (AD), memory complaint patients with cognitive impairment (MC) and memory~     complaint patients cognitively normal (CNE). The first phase includes four weeks treatment~     with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18~     FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU)~     period with EGb761® treatment in MC and CNE patients.~   "
209831|NCT00814333|"~     Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally~     epistaxis can be severe enough to require emergency room admission. Among the treatment~     options for epistaxis, nasal packing is the most common approach. This approach requires a~     return visit to the clinic for removal of the packing. Additionally, there is a great deal of~     pain during the insertion and removal of this packing. This study aims to justify the further~     investigation of thrombin as a potential treatment approach for these patients. Thrombin~     could provide a treatment approach that reduces pain and eliminates the need for a return~     visit to the clinic.~   "
209832|NCT00814320|"~     The purpose of the study is to develop a subcutaneous treatment option for participants with~     Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin~     Intravenous (Human), 10% at the same frequency as IV administration.~   "
209833|NCT00814307|"~     This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550~     when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to~     severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in~     improving signs and symptoms and physical function that were observed in the Phase 2~     Rheumatoid Arthritis studies.~   "
209834|NCT00814294|"~     The primary objective of this trial is to compare the reduction in mean glycated hemoglobin~     levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on~     background metformin therapy at the end of 18 weeks of treatment.~      The secondary objectives are:~        -  To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test,~          fasting plasma glucose (FPG), insulin, homeostasis model assessment of insulin~          resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β),~          frequency of hypoglycemic events, body weight, and lipid levels; and~        -  To evaluate the safety and tolerability of oral HDV-I.~   "
209835|NCT00814281|"~     The purpose of this study is to examine biological pathways of altered blood vessel function~     resulting from breathing airborne particulate. Blood artery function in healthy men will be~     measured after particulate exposure either on placebo or on an asthma medication that stops~     production of an inflammatory biological agent. Lung and blood profiles will be obtained~     before and after exposure to exhaust fumes. We believe that the inflammatory agent produced~     by the lungs from breathing these particles causes abnormal artery function.~   "
209836|NCT00814268|"~     Primary objective:~        -  Comparison of efficacy of the combination therapy (clopidogrel plus aspirin) and the~          aspirin alone (main comparison) to prevent any recurrent ischemic lesion .~      Secondary objectives:~        -  Comparison of Modified Rankin scale (mRS) scores;~        -  Comparison of the Incidence of all kinds of stroke and vascular death;~        -  Comparison of the Incidence of bleeding episodes (major and minor) and symptomatic~          intracerebral hemorrhages during the follow-up period.~   "
209837|NCT00814255|"~     This project will test whether adalimumab,and/or galactose can safely reduce proteinuria~     (abnormal amounts of protein in the urine) and protect kidney function better than standard~     treatment for patients with focal segmental glomerulosclerosis (FSGS).~   "
209838|NCT00814242|"~     This study will compare and analyze the difference between hepatectomy at deep and complex~     sites(adjacent to major blood vessels) of patients with HCC and PRFA prognosis, recovery~     after treatment as well as incidence of complications so as to establish treatment standards~     of HCC at these sites.~   "
209839|NCT00814229|"~     H9N2 influenza circulates in animal and poultry and has caused delf limiting infections in~     children. Influenza H9N2 poses a pandemic threat to humans.~      This study evaluates the safety and immunogenicity of adjuvanted and non-adjuvanted whole~     virus and virosomal H9N2 vaccines by the intramuscular route. We also assess intradermal~     route of administration to see if this has any advantages. The aim is to assess antibody~     responses before and after vaccination. The hypothesis is that lower doses of adjuvanted~     vaccine will induce similar antibody responses to non-adjuvanted vaccine~   "
209840|NCT00814216|"~     This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week~     administration of oral QAV680 in the treatment of patients with asthma.`~   "
209841|NCT00814203|"~     To develop a cohort of COPD participants to assist study staff in determining the most likely~     candidates for future studies.~   "
209842|NCT00814190|"~     Management of diabetes is an evolving challenge to health care professionals. The~     fluctuations of glucose levels over the lifetime of patients with diabetes can lead to~     complications such as nephropathy, neuropathy, retinopathy and cardiovascular diseases.~     Although diabetes is a chronic disease, it can be controlled with use of medications (pills~     or insulin), and/or changes in life-style and diet. These interventions are aimed at keeping~     the blood glucose levels normal or in the range of acceptable levels.~      An important aspect of diabetes care is the monitoring of blood glucose levels in order to~     assess the effectiveness of treatment and to modify the treatment to achieve the desirable~     glucose levels. Patients with type 2 DM treated with insulin are recommended to perform~     testing for their blood glucose levels; however, it often requires intervention by health~     professionals in order to prevent the immediate and serious complications of hyper or~     hypoglycemia. The frequent self-monitoring of blood glucose and effective interventions by~     the health professionals may eventually allow tighter control of blood glucose levels and~     delay or prevent the complications associated with diabetes.~      In this study, the investigators wish to evaluate the effect of an Internet based remote~     monitoring system that allows for patients to upload their blood glucose readings online and~     for the health care professional to view and provide feedback or therapeutic intervention.~     The Internet based system has the features of presenting the blood glucose readings according~     to the time of day and automatically calculates the daily average plus the standard~     deviation. A visual graph of the glucose readings over a 24-hour period is also generated for~     view. In addition, the doctor can give feedback by sending messages through the system. The~     patient's personal information is kept secure as outlined by the privacy policy of the~     Internet based system and only the doctor and the patient can view the uploaded glucose~     readings.~      The investigators propose that the standardized encounters using the Internet will improve~     the outcome of treatment for patients with type 2 DM.~   "
209868|NCT00813852|"~     The purposes of this study includes (1)to investigate inspiratory muscles and non-inspiratory~     muscle function in terms of strength, endurance, and fatigability in patients with~     obstructive sleep apnea (OSA), (2) investigate the metabolic characteristics of peripheral~     muscles and biochemistry markers in patients with OSA, and (3) to detect the effect of~     exercise training on the measured parameters in patients with OSA.~   "
209869|NCT00813839|"~     This study will compare Drager Smart Care (SC), a commercially available automated ventilator~     controlled weaning mode to the current daily spontaneous breathing trial (SBT) weaning~     protocol. The study is designed to determine if automated ventilator controlled weaning can~     reduce total duration of intubation following mechanical ventilation in ICU patients~     requiring prolonged mechanical ventilation (>72 hours).~   "
209870|NCT00813826|"~     The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain~     associated with post-herpetic neuralgia (PHN) in recently diagnosed patients.~   "
209843|NCT00814177|"~     Warfarin is very effective for the prevention of blood clots (thrombosis). A test of~     coagulation, the prothrombin time (PT) is used to monitor the effect. The PT response to~     warfarin can fluctuate as a result of interactions with a large number of other drugs, food~     or herbal agents as well as for no apparent reason. Thus, frequent monitoring of the PT and~     dose adjustments according to the results are required. One third of our patients remain on~     the same maintenance dose over 6 months. However, also these patients sometimes have a PT~     result moderately outside the therapeutic range without any obvious explanation. Too short~     PTs may be due to missed dose(s) or more dark green vegetables in the diet. Too long PTs may~     be due to a course of antibiotic therapy or less dark green vegetables. Laboratory errors may~     also occur and can cause deviations in any direction. Most likely, unnoticed fluctuations in~     the PT occur as well between the time points of monitoring.~      There are no guidelines on how to manage the treatment in this situation but there are some~     typical behaviours.~      Behavior A: Some physicians simply let the patient continue with the same dose. It is~     extremely unlikely that the very temporary dose adjustment has any effect on the PT result 4~     weeks later and this is a cosmetic procedure. Behavior B: Others recommend the patients to~     take ½ - 1 additional dose in case of short PT and to skip a dose or take half dose in case~     of long PT, and thereafter to continue with the usual dose. The investigators need to~     quickly correct the temporary aberration in order to avoid thrombotic or bleeding~     complications the next few days.~      This may seem like an issue of no importance. The investigators are however performing a~     series of studies to evaluate if these stable patients can be managed with blood tests less~     often than every 4 weeks. For that purpose it is important to know how often and why aberrant~     results occur, the implication and to what extent they can be ignored.~      The investigators hypothesis is that in patients with very stable PT-results and unchanged~     dose for 3 months, should continue with exactly the same maintenance dose, even when the~     result unexpectedly is slightly above or below the therapeutic range. The investigators~     believe that most of these occasional PT-results outside the therapeutic range are due to~     laboratory errors, perhaps missed doses by the patient or temporary change in diet or~     medications.~   "
209844|NCT00814164|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving clofarabine together with~     daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.~   "
209845|NCT00814151|"~     In-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and~     methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's~     bacteriophage-based diagnostic platform.~   "
209846|NCT00814138|"~     Myasthenia gravis is a rare neuromuscular disorder characterized by weakness and fatigability~     of ocular, bulbar, and extremity musculature. The specific aim of this study is to determine~     if oral methotrexate is an effective therapy for myasthenia gravis (MG) patients who are~     prednisone dependent. Patients will be randomized to receive either methotrexate or placebo~     and those who are entered onto this trial will have symptoms and signs of the disease while~     on prednisone therapy. The hypothesis is that adding methotrexate therapy in these patients~     will improve the MG manifestations so that the prednisone dose can be reduced and clinical~     measures of MG severity will improve.~      Funding Source - FDA OOPD~   "
209847|NCT00814125|"~     To compare the difference between the ARIMIDEX group and the tamoxifen group in the incidence~     of abnormal endometrial histological findings arising after treatment has commenced.~   "
209848|NCT00814112|"~     We have previously shown that the plasma level of glycosaminoglycans (GAG) in septic shock~     patients are elevated compared to controls. The purpose of this study is to investigate the~     temporal dynamic of the blood level of GAG in ten septic shock patients. In addition, to~     assess the kinetics of GAG during septic shock we examine the liver function by galactose~     elimination capacity as well as excreted urinary GAG.~   "
209849|NCT00814099|"~     People with acute respiratory failure usually require the use of an artificial breathing~     machine, known as a mechanical ventilator. Sedative medications, which help keep people calm~     and reduce anxiety, are often prescribed for children who are on mechanical ventilators.~     However, the longer that sedative medications are used, the longer a child may need to remain~     on mechanical ventilation. This study will evaluate the effectiveness of a team approach to~     sedation management that aims to reduce the number of days that children with acute~     respiratory failure require mechanical ventilation.~   "
209850|NCT00814086|"~     This phase I trial is studying the side effects and best dose of cisplatin given together~     with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV~     ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs~     used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) and giving them in different ways may kill more~     tumor cells.~   "
209851|NCT00814073|"~     The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to~     placebo in patients with mastocytosis with handicap.~   "
209852|NCT00814060|"~     This study will examine the bioavailability (the rate and extent to which the active~     ingredient or active moiety is absorbed from a drug product and becomes available at the site~     of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule~     formulation.~   "
209853|NCT00814047|"~     Blood flow autoregulation is defined as the ability of a tissue to maintain a relatively~     constant flow, despite moderate alterations in perfusion pressure. Similar to the cerebral,~     renal, coronary and skeletal muscle circulations, the ocular vascular bed shows the property~     of flow autoregulation. This homeostatic mechanism allows blood supply to the eye to match~     metabolic demand during daily activities, such as changes in posture, or in more critical~     conditions.~      Autoregulation has been found to be a complex phenomenon, showing heterogeneity in its site~     and time course of action. Since metabolic, myogenic, neurogenic and possibly~     endothelium-related mechanisms may be involved, several factors may vary depending on the~     challenging stimulus, the vessel tone, or the degree of impairment of autoregulation.~      To study the dynamics of ocular autoregulation, it is necessary to introduce a step~     disturbance (stimulus) in ocular perfusion pressure and to record the responses of ocular~     blood flow continuously before and after this step disturbance. The investigators have~     employed a mechanical noninvasive technique to induce an ocular perfusion pressure step~     disturbance without drugs or changes in the concentration of vasoactive substances in the~     blood by using the thigh cuff technique inducing a small step decrease in ocular perfusion~     pressure.~      With this technique the investigators could show significant differences in the time response~     of blood velocities in the ophthalmic and middle cerebral artery. This clearly indicates~     different mechanisms to be responsible for autoregulatory mechanisms distal to the vessels.~      Interestingly our results indicate that in the ophthalmic artery a late vasoconstriction~     occurs. Many previous investigations have demonstrated that sympathetic nerve stimulation~     causes vasoconstriction in the ocular circulation. Accordingly, the present study tests the~     hypothesis that α2-adrenoceptors are involved in the dynamic regulation of blood flow in the~     ophthalmic and middle cerebral artery after a step decrease in perfusion pressure.~   "
209854|NCT00814034|"~     The objective of the study is to monitor the changes of blood coagulation parameters in~     postmenopausal patients who are treated with adjuvant Hormonal Therapy for a total of 5~     years. The values of the standard coagulation parameters throughout the study will be~     compared with the baseline values.~   "
209871|NCT00813813|"~     Study to show the effectiveness and safety of a single injection of rhGDF5 into a~     degenerating single spinal disc in treating lumbar level degenerative disc disease~   "
209856|NCT00814008|"~     Impaired retinal blood flow has been implicated in the pathogenesis of diabetic retinopathy.~     Patel et al. (1992) showed that retinal blood flow increases with the level of diabetic~     retinopathy. Grunwald et al. (1996) reported that patients with insulin dependent diabetes~     mellitus (IDDM) of relatively short duration have increased retinal blood flow, even before~     the onset of diabetic retinopathy. On the other hand the data of Bursell et al. (1996)~     indicate that IDDM patients have reduced retinal blood flow, when they have normal blood~     glucose levels, but this study may have considerable methodological limitations. Acute~     elevations of blood glucose levels, however, result in an increase in retinal blood flow~     (Grunwald et al. 1987, Bursell et al. 1996). Based on previous experimental data the~     investigators hypothesize that ocular blood flow is increased in early diabetes and reduced~     at later stages of the disease. Previous studies have demonstrated that metabolic conditions~     such as hyperglycemia influence outcome parameters and thereby might have confounded results~     regarding ocular blood flow in diabetic retinopathy. The investigators will therefore study~     patients with IDDM during euglycemic conditions.~   "
209857|NCT00813995|"~     A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo~     in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.~   "
209858|NCT00813982|"~     The purpose of this study is to compare an experimental contact lens with a currently~     marketed contact lens.~   "
209859|NCT00813969|"~     The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal~     stem cell transplantation, involving approximately 24 ambulatory participants with relapsing~     forms of MS (approximately equal numbers with relapsing-remitting and secondary progressive/~     progressive relapsing MS) and evidence of involvement of the anterior afferent visual system.~   "
209860|NCT00813956|"~     This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin,~     and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve~     a pathologic complete response prior to surgery.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
209861|NCT00813943|"~     CORE is a Phase 2 clinical trial in newly diagnosed glioblastoma in subjects with an~     unmethylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in~     the tumor tissue.~      The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling~     element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to~     appear to be a predictive marker for benefit from temozolomide (TMZ) treatment.~      In a safety run-in period in dedicated study centers, the safety and tolerability of~     Cilengitide given as an intense treatment in combination with the first part of standard~     therapy will be assessed. Thereafter the trial will investigate the overall survival and~     progression-free survival in subjects receiving two different regimens of Cilengitide in~     combination with standard treatment versus standard treatment alone.~   "
209862|NCT00813930|"~     Chronic disease management programs are shown to reduce mortality, recurrent~     hospitalizations, and improve indirect societal costs among specific subgroups of the~     population. INTERxVENT is one such individualized chronic cardiovascular and lifestyle~     management program, comprised of several individualized modules - diet, exercise, stress~     management, smoking cessation, chronic disease - prescribed algorithmically according to~     patient risk profile, environmental surroundings, and behavioural readiness-to-change.~     Nonrandomized studies assessing INTERxVENT in diabetic, pre-diabetic, and metabolic syndrome~     populations have demonstrated improvement in several intermediary endpoints, including~     reductions in fasting glucose, lipids, and blood pressure. However, no randomized controlled~     clinical trials in these populations have been conducted. This pilot study is a randomized~     clinical trial evaluating the effectiveness of INTERxVENT as compared with 'usual medical~     care' in improving cardiovascular risk-factor profiles among individuals with diabetes.~     Additionally, the extent to which such findings are generalizable to diabetic, socially~     vulnerable, populations is unknown, thus this will be examined also.~   "
209863|NCT00813917|"~     Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with~     specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable~     efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel~     mechanism of action of varenicline potentially circumvents the limitations of using nicotine~     replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line~     of research is to develop effective pharmacologic treatments for ST users to increase~     long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that~     varenicline is efficacious for the treatment of ST users.~   "
209864|NCT00813904|"~     The objective of this study is to assess the immunogenicity and safety of recombinant~     Thrombin (rThrombin) in patients with prior rThrombin exposure.~   "
209865|NCT00813891|"~     The purpose of the investigators study is to look at the visual outcomes of Ranibizumab~     injections in combination with photodynamic therapy for the treatment of neovascular~     age-related macular degeneration.~   "
209866|NCT00813878|"~     RATIONALE: Diagnostic procedures that measure biomarker levels in nipple section and blood~     samples, may help in the early detection of breast cancer.~      PURPOSE: This clinical trial is studying nipple secretion samples in detecting breast cancer~     in patients and healthy participants undergoing breast cancer screening, breast diagnostic~     studies, or treatment for benign breast disease.~   "
209867|NCT00813865|"~     This study will measure the long-term safety of AT2101 and its effects on hemoglobin,~     platelets, liver and spleen volume, and bone density. This study will also look at the~     effects of AT2101 on beta-glucocerebrosidase levels, glucosylceramide levels, and other blood~     markers of Gaucher disease.~   "
209990|NCT00812253|"~     Patients with heart failure often have high blood sugar (glucose).~   "
209991|NCT00812240|"~     The objective of the study is to compare the efficacy and safety of masitinib to imatinib in~     patients with gastro-intestinal stromal tumour (GIST) in first line medical treatment.~   "
209872|NCT00813800|"~     Patients with bipolar disorder have one of the highest rates of nicotine dependence and one~     of the lowest quit rates. Varenicline has been shown in previous trials to be effective for~     smoking cessation, but has not been studied in subjects with bipolar disorder. This 12-week~     open label trial will be conducted to assess the feasibility, acceptability, and safety of~     varenicline in bipolar depressed smokers, given in addition to the subject's primary~     treatment for bipolar disorder. The primary study hypothesis was that the abstinence rate for~     bipolar depressed patients will be 50%.~   "
209873|NCT00813787|"~     The purpose of this study is to see if a specialized imaging technique using MRI called~     multi-exponential T2 component analysis can reliably differentiate between normal brain and~     brain tumour.~   "
209874|NCT00813774|"~     To compare the bioavailability of a single dose of certolizumab pegol solutions given~     subcutaneously either by one of the three formulations and to investigate safety and~     tolerability.~   "
209875|NCT00813761|"~     The purpose of this study is to compare two marketed contact lens care solutions in regards~     to comfort and ocular health.~   "
209876|NCT00813748|"~     This study will establish a clinical data and serum repository of anaphylaxis cases~     associated with Xolair administration and control patients who have received Xolair without~     associated anaphylaxis. This is an observational repository and not an investigational~     clinical trial. Associated with the repository is an optional skin testing substudy.~   "
209877|NCT00813735|"~     Research has established the incidence of insomnia increases with age and the possible causes~     contributing to sleep problems in the elderly are still being explored and debated. Older~     adults use a disproportionately large share of sleep aids with non-prescription sleep aid use~     having increased over the past decade. This study is a double blind safety and effectiveness~     trial examining the response of eszopiclone co-administered with escitalopram for the~     treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.~   "
209878|NCT00813722|"~     The purpose of this study is to evaluate the importance of providing guidelines to patients~     via active telephone calls in blood pressure control and in the discontinuation of treatment~     among hypertensive patients. Hypertensives (N = 354) who could receive telephone calls to be~     reminded of the dates of their medical appointments and to be instructed about hypertension~     were distributed into two groups: a) uncomplicated - hypertensives with no other concurrent~     diseases; and b) complicated - severe hypertensives (mean diastolic ≥ 110 mm Hg with or~     without medication) or comorbidities. All patients, except those excluded (n=44), were open~     block randomized to follow two treatment regimens: traditional or current and to receive~     active telephone calls (phone calls group) or not to receive telephone calls (no phone~     calls group).~   "
209879|NCT00813709|"~     REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose~     of the study is to obtain long-term follow-up data in subjects with clinically definite~     multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of~     converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free~     formulation of interferon [IFN]-beta-1a (RNF).~   "
209880|NCT00813696|"~     The purpose of this study is to evaluate the impact of the addition of cisplatin to~     gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.~   "
209881|NCT00813683|"~     We want to study the efficiency of acupuncture for cephalic version of breech presentation~     during pregnancy.~      Several randomized studies show that acupuncture may be useful in version of breech~     presentation, but none with a sham.~      Protocol :~        -  Inclusion of patients with fetus in breech presentation at 32-34 weeks of pregnancy.~        -  Randomization. First group : acupuncture by stimulation of 67 Bladder point.Second~          group : stimulation of 45 Stomach point (sham).~        -  Ultrasonographic control of presentation at 35 weeks.~   "
209882|NCT00813670|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     single and multiple doses of XPF-001 in healthy volunteers.~      The effect of food on the pharmacokinetics of XPF-001 will also be studied.~   "
209883|NCT00813657|"~     The investigators investigated the effects of a supervised maternal exercise training program~     (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health~     outcomes in a group of previously sedentary healthy women. A matched control group was~     assessed over the same time period. Given the fact that most studies in the field have used~     aerobic exercises, here the investigators largely focused on very light resistance, toning~     exercises.~   "
209884|NCT00813644|"~     The development of virtual reality (VR) simulators is changing surgical endoscopic education.~     The translation of VR skills into clinical endoscopic proficiency has been shown by M.PEARLE.~     The improvement in performing endoscopic tasks after VR training was evaluated on a cadaver.~     Our goal is to evaluate the performance of novice endoscopists at the operating room by a~     randomized controlled study comparing subjects randomized to train on a the UroMentor~     simulator to those without VR training.~   "
209885|NCT00813631|"~     Background. Malignant fungating wounds(MFW) are caused by cancerous cells invading skin~     tissue, which exhibit increased bacterial burdens that not only result in a negative physical~     impact (odour, exudates, pain, and infection) on patients, impairing their quality of life,~     but they also increase treatment costs. A systematic review of the effectiveness of that the~     silver-releasing dressing in the management of infected chronic wounds can help enhance~     control of wound bed infection and inflammation, tissue management, moisture balance, and~     protect wound edge. However, few studies have examined the effects on people with MFW.~      Hypothses In this study that the hypothesized that cancer patients in the ionic silver~     dressing group will perception higher quality of life compared to patients in the control~     group who receive non-ionic silver dressing. In addition, we hypothesized that cancer~     patients who also receive ionic silver dressing will have lower level of symptom distress at~     end of study compared to patients in the control group receive non-ionic silver dressing~     care.~   "
209886|NCT00813618|"~     To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone~     marrow allograft recipients who have at least Grade II GvHD.~   "
209996|NCT00812175|"~     In this international non-interventional study safety and clinical data concerning the~     treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.~   "
229053|NCT00558844|"~     This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg~     of Arikace™ versus placebo in patients who have Cystic fibrosis.~   "
209887|NCT00813605|"~     This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled,~     three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150~     eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line~     fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be~     randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479~     plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI~   "
209888|NCT00813592|"~     This is a single-arm, phase II trial of SOM230 in patients with documented recurrent or~     progressive intracranial meningioma who have failed conventional therapy and are not~     candidates for complete surgical resection of their tumors and/or radiation at the time of~     study entry.~      At the time of the final analysis, all patients who are receiving treatment with SOM230 will~     complete the core phase of the study and will continue on the extension phase. During this~     time, additional data on response duration, PFS, and safety will be collected.~   "
209889|NCT00813579|"~     This is a prospective assessment of 80 living kidney donors.~   "
209890|NCT00813566|"~     The standard treatment approach for patients with high-grade primary brain tumors includes~     maximum feasible surgical resection, followed by 6 weeks of concurrent cranial irradiation~     and daily low-dose temozolomide chemotherapy, followed by 12 cycles of high-dose temozolomide~     administered for 5 consecutive days every 4 weeks [Stupp 2005]. Contrast-enhanced MRI is the~     current standard for evaluating the success of therapy and monitoring for tumor recurrence.~     MRI is typically obtained prior to initial surgery, within 24 hours after surgery, at the~     conclusions of cranial irradiation, and then every 8 weeks during temozolomide chemotherapy~     until evidence of recurrence. Despite this careful clinical and radiographic surveillance,~     and despite decades of research into the histologic and molecular classification of primary~     brain tumors, our ability to predict tumor behavior remains very limited. Some gliomas will~     result in overall survival times of only months, whereas other histologically-identical~     gliomas may yield survivals of years to decades [Carson 2007, Curran 1993, Lamborn 2004].~     Current assessment of tumor response to therapy is also poor. Patients with complete~     radiographic response after cranial irradiation often progress rapidly post-irradiation. In~     contrast, some patients with enhancing masses at the end of chemoradiotherapy may respond~     dramatically to further chemotherapy alone, or the masses may even disappear in the absence~     of further therapy (so called tumor pseudoprogression) [Chamberlain 2007]. This confounding~     situation demonstrates a need for better assessment of tumor response.~   "
209891|NCT00813553|"~     Carnosine is a natural acid buffering substance of muscle. The primary objective of this~     study is to test whether a nutritional supplement of beta-alanine enhances carnosine content~     in muscle.~   "
209892|NCT00813540|"~     Recent studies have suggested that individuals diagnosed with colon cancer who are inactive~     and/or overweight, may have poorer survival outcomes. Exercise training has been shown to~     improve fitness and body composition in other cancer survivor groups. The investigators~     hypothesize that an exercise training program will be a safe, feasible, and effective~     intervention to improve the fitness and body composition of a group of colon cancer~     survivors.~   "
209893|NCT00813527|"~     The purpose of this study is to compare changes in cholesterol levels in patients with~     elevated blood cholesterol with administration of lapaquistat acetate, once daily (QD), and~     fenofibrate.~   "
209894|NCT00813514|"~     Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic~     component. Most importantly a genetic polymorphism in the gene encoding for the complement~     factor H (CFH) has been recently identified which is highly associated with an increased risk~     of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated~     to play a role in the development of the disease.~      For this purpose a total of 200 patients with wet AMD will be included in the study. As~     described in detail below, the current study aims to identify potentially non-responders to~     anti-VEGF therapy based on genetic analysis of VEGF polymorphism and complement factor H~     polymorphism.~   "
209895|NCT00813501|"~     RATIONALE: Studying a diagnostic biomarker test in blood samples from patients who have~     undergone a donor stem cell transplant for cancer may help doctors plan treatment.~      PURPOSE: This clinical trial is studying an immunologic diagnostic blood test to see how well~     it works in predicting side-effects in patients with hematologic cancer or other disorders~     who have undergone a donor stem cell transplant.~   "
209896|NCT00813488|"~     Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with~     immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid~     tolerant patients with chronic pain.~   "
209897|NCT00813475|"~     To test whether tight glucose control is associated with better clinical outcome compared to~     less-tight control, among diabetic patients hospitalized in internal medicine wards.~   "
209898|NCT00813449|"~     Multicenter, double-blinding, randomized controlled, phase II clinical trial on combined~     chemotherapy of Endostar (Recombinant Human Endostatin) for untreated patients with advanced~     melanoma, To compare the efficacy and safety of Endostar combined with Dacarbazine and~     monotherapy of Dacarbazine for advanced melanoma~   "
209899|NCT00813436|"~     Empathy constitutes one prominent ability of social cognition, which represents the human~     capability of understanding mental state of the other, and responding in sympathetic way. Two~     sets of theoretical mechanisms were designed in order to explain how empathy is possible.~     Theory of Mind (ToM)and Simulation.People who suffer from schizophrenia frequently exhibit~     social dysfunction, preventing them of a normal integration in healthy human environments.~     Recently it had been discovered that impairment in empathy and a specific impairment in~     effective TOM are mostly associated with the social malfunctioning of people who suffer from~     schizophrenia. One of the biological substances most connected to social cognition is the~     neuromodulator Oxytocin. Among its known involvement in uterine contractions and lactating~     females, numerous recent studies have found an indispensable role for Oxytocin in various~     complex prosocial behaviors such as maternal behavior, attachment, partner preference and~     trust. In the proposed study, we plan to examine the influence of a single dose of intranasal~     Oxytocin on the two primary mechanisms of empathy, namely mentalizing (Theory of Mind) and~     Simulation, both in healthy people and in people who suffer from schizophrenia.~   "
221809|NCT00655447|"~     At the time of hysterectomy for benign disease, the overall health benefits of preserving~     ovarian function in a large population of women have not been established.~   "
209900|NCT00813423|"~     This phase I trial studies the side effects and best dose of sunitinib malate when given~     together with hydroxychloroquine in treating patients with advanced solid tumors that have~     not responded to chemotherapy. Sunitinib malate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~     Hydroxychloroquine may help sunitinib malate work better in treating solid tumors. Giving~     sunitinib malate together with hydroxychloroquine may kill more tumor cells.~   "
209901|NCT00813410|"~     The study seeks to use microdialysis and microperfusion techniques to assess the feasibility~     of performing insulin delivery and glucose sensing at a single subcutaneous tissue site.~   "
209902|NCT00813397|"~     This study will examine the performance of SeprasSpray in patients undergoing abdominal~     surgery (laparoscopic).~   "
209903|NCT00813384|"~     First in human, open-label, sequential dose escalation and expansion study of AMG 208 in~     subjects with advanced solid tumors.~   "
209904|NCT00813371|"~     The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients~     decreases the incidence and severity of acute lung injury and Acute Respiratory Distress~     Syndrome and allows faster recovery of lung function.~   "
209905|NCT00813358|"~     The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further~     study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment~     of thoracic aortic aneurysms.~   "
209906|NCT00813345|"~     We previously evidenced in both animal models and patients that a short duration ambulatory~     anesthesia impacts the circadian rest-activity biological rhythm, at least during the first 3~     days. The light is the main, natural synchronisateur, of the biological cerebral clock, and~     is used as therapeutics in chronic disturbances of the circadian rest activity rhythm and of~     the sleep (Alzheimer disease for example). We would like to test for a simple and safe~     strategy to prevent such a long-lasting effect of anesthesia on biological clock:the increase~     of the light intensity at a still physiological level during the initial phase of recovery~     from anesthesia by using a particular artificial light of color spectrum similar to natural~     sun daylight.~   "
209907|NCT00813332|"~     The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant~     Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center,~     double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have~     obvious progressive disease or intolerant adverse effects in first-line chemotherapy.~   "
209908|NCT00813319|"~     African American adolescent females seeking treatment for STIs are an underserved population~     at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine,~     vaccination rates are low. Given the risk for HPV infection among this subgroup and the~     negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. The~     goal of this project is to promote GARDASIL vaccination through the development of a new~     multi-component, culturally-appropriate, interactive DVD.~      We propose to recruit 280 unmarried African American adolescent females, 13-18 years of age,~     from participating clinic sites in Atlanta, Georgia. While seeking clinical services,~     adolescents will be contacted and invited to participate in the proposed study. Eligible~     adolescents will be required to provide written assent/consent prior to participation.~     Adolescents who are eligible and willing to participate in the project will complete a short~     survey on a laptop computer. The survey is designed to assess adolescents' risk taking and~     preventive behaviors. After they complete the survey, adolescents will be assigned at random~     to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD~     designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to~     help them remember to return to the clinic for their second and third vaccine doses. In the~     second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and~     behaviors. All adolescents are eligible to receive the GARDASIL vaccine at participating~     study clinics as part of their routine standard of care.~      With the help of clinic staff, participant medical records will be reviewed over a 7 month~     period to assess vaccination rates. Vaccination rates from adolescents who received the~     interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who~     received the healthy lifestyles DVD. It is hypothesized that study participants receiving the~     interactive DVD intervention that promotes HPV awareness will have higher vaccination rates~     over time.~   "
209909|NCT00813306|"~     The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore~     the effect of a single dose of AZD2066 on the function of the cardia (the opening between the~     stomach and the esophagus) compared to placebo (not containing any medical substance) in~     healthy volunteers.~   "
209910|NCT00813293|"~     The purpose of this research study is to determine if sorafenib improves the effectiveness of~     a procedure called radiofrequency ablation for the treatment of hepatocellular cancer. During~     radiofrequency ablation (RF ablation) a needle is inserted into the tumor tissue and heat is~     used to kill the tumor cells.~      Sorafenib has been approved by the FDA for the treatment of hepatocellular cancer that cannot~     be treated with surgery. Radiofrequency ablation has been used to treat many types of tumors,~     including hepatocellular cancers. Pre-clinical data suggests that sorafenib may improve the~     efficacy of RFA. The use of sorafenib prior to RF ablation in this study is investigational~     and has not been approved by the FDA. Investigational means that this combination is still~     being studied and that research doctors are trying to find out more about it. In this study,~     the study doctors hope to better understand the extent to which the combination of sorafenib~     and RFA may be done practically and successfully. Correlative imaging and tumor studies will~     evaluate mechanisms of action as well as novel predictors of RFA efficacy.~   "
209911|NCT00813280|"~     The major purpose of this Quality Improvement project is to begin to address the issues~     surrounding glycemic control in the hospital setting by collecting accurate, reliable and~     verifiable data on the occurrence of hyperglycemia (BG >300 mg/dL), and whether or not CIO is~     used (immediately before and 72 hours after the BG >300 mg/dl).~   "
209912|NCT00813267|"~     Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing~     properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and~     complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and~     BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine~     whether this treatment will result in improvement in osteonecrosis of the femoral head.~   "
209913|NCT00813254|"~     The goal of this research study is to learn about the quality of life and sexual functioning~     of women with platinum-resistant ovarian cancer as they receive other treatments for the~     disease.~      Researchers will study the costs for chemotherapy treatments, other medical expenses, and~     treatment-related expenses that are not medical. Researchers will also review any symptoms~     these patients may experience related to the cancer or treatment.~      In addition, researchers want to learn if and how these patients' caregivers feel the status~     of these patients' health may have affected the caregivers' productivity at work and at home.~   "
209914|NCT00813241|"~     A pharmacokinetic study in healthy volunteers to determine the relative bioavailability of~     three formulations of celecoxib to the approved formulation.~   "
209915|NCT00813228|"~     Patients with diabetes have high blood sugar levels (hyperglycemia) because pancreatic~     beta-cells no longer produce sufficient insulin. Insufficient beta-cell function can be~     caused by an autoimmune killing of the beta-cells in type 1 diabetes (T1D), or by poorly~     understood mechanisms in type 2 diabetes (T2D). Glucagon-like peptide-1 (GLP-1) improves~     function of the insulin-producing beta cells, but GLP-1 has a very short circulating~     half-life because it is cleaved by the enzyme dipeptidyl peptidase IV (DPP-4). One current~     treatment being used to improve glycemia control in patients with T2D is sitagliptin, an~     inhibitor of DPP-4. By inhibiting DPP-4, sitagliptin increases GLP-1 levels, resulting in~     improved beta cell function. Sitagliptin is now being tested in individuals with new-onset~     T1D to determine whether it may help to preserve beta cell function. Because T1D is a disease~     in which the immune system destroys the insulin-producing beta cells in the pancreas, we wish~     to determine if and how sitagliptin alters immune function. Sitagliptin has been shown by~     Merck to be safe and effective with no overt immuno-toxicities. However, several lines of~     evidence suggest that DPP-4 inhibitors such as sitagliptin could be immunomodulatory.~      This randomized clinical trial will study immune function in healthy volunteers given~     short-term (4 week) treatment with either sitagliptin or placebo. During the study, we will~     take blood samples at various time intervals before, during and after treatment. We will~     compare the immune response with and without sitagliptin treatment using blood samples from~     healthy individuals. We will measure changes in the magnitude and type of immune responses.~     The study period is nine weeks. The study s primary outcome will be changes in blood plasma~     levels of a protein marker associated with decreased inflammation: Transforming Growth Factor~     Beta 1 (TGF beta 1). In addition, we plan to use these blood samples to measure sitagliptin s~     effect on expression levels of several cytokines (immune proteins). We will also measure the~     level of proliferation in stimulated PBMCs (blood immune cells) and gene expression in whole~     blood after sitagliptin treatment.~   "
209916|NCT00813215|"~     Type 2 diabetes (T2D) is a common disease associated with multiple complications and an~     increased risk of cardiovascular morbidity and mortality. Also, it is a heavy economical~     burden on society. 1st degree relatives of patients with T2D have an increased risk of~     developing T2D. This risk can be modified by the ingested diet: a traditional north European~     diet rich in saturated fat increases the risk, while a Mediterranean diet rich in~     monounsaturated fat protects from development of T2D and cardiovascular disease.~      T2D is a part of the metabolic syndrome consisting of T2D, hypertension, adipositas,~     dyslipidemia and steatosis. The pathogenesis of the metabolic syndrome is partly explained by~     fasting dyslipidemia, postprandial dysmetabolism (derangement of lipid and carbohydrate~     metabolism) and impaired metabolic flexibility. Partly, it can be explained by a chronic~     low-grade inflammation in peripheral tissue. The dysmetabolism and the inflammation are~     correlating entities exerting their influence through common biochemical pathways. This is~     established in patients with T2D, but sparsely studied in healthy relatives of patients with~     T2D.~      In this project, the investigators will study postprandial dysmetabolism, inflammation,~     oxidative stress, adipocytokines, incretins, appetite regulating hormones and the expression~     of the genes involved in above mentioned. We will compare healthy 1st degree relatives of~     patients with T2D with healthy controls with no family history of T2D and look into~     differences in the response to meal stimulation with respectively saturated and~     monounsaturated fat. The subjects will be thoroughly examined with a hyperinsulinaemic~     euglycaemic clamp and a DEXA scan. Before and after the meal stimulation, we will perform~     calorimetry (in order to determine the metabolic rates), take blood samples and perform~     muscle and fat tissue biopsies. The biopsies will be used for studies of a vast number of~     genes.~      The project will give us new valuable knowledge about the interaction between the~     intermediate metabolism and the innate immune system and the early pre-diabetic changes in~     the 1st degree relatives of patients with T2D. In the long run, the project will contribute~     to improving our guidance and treatment of persons at risk of developing T2D.~   "
209917|NCT00813202|"~     The present study was an open-label, uncontrolled, and multi-centered phase III clinical~     trial for evaluation of the efficacy (clinical efficacy and hemodynamics) and safety of~     nesiritide.~   "
209918|NCT00813189|"~     Children suffering from chronic disease and receiving long-term glucocorticoid therapy suffer~     over years from severe growth retardation and profoundly altered body composition. They~     consist in a marked increase in fat mass and a decrease in lean body mass. Published studies~     have shown that Growth Hormone (GH) treatment in children with Juvenile Idiopathic Arthritis~     can improve body composition by increasing lean mass and by preventing increase in fat mass.~     The aim of the present protocol is to evaluate whether the increase in lean body mass~     observed during GH treatment is associated with changes in muscle strength and mass.~      In order to be able to evaluate the effect of GH on the muscle a comparative group is needed.~     Therefore it will be proposed to delay in a group of patients the start of Growth Hormone(GH)~     treatment by 6 months. As most publications have shown a maximum effect of GH within the~     first year of treatment, six months should be enough to evaluate short-term effect of GH on~     the muscle. Therefore, this study will be a randomized trial: immediate start of Growth~     Hormone (GH) treatment versus start of Growth Hormone treatment 6 months later. After 6~     months all children will be treated with GH. Therefore, the follow-up will be one year after~     baseline.~   "
209919|NCT00813176|"~     The purpose of this study is to determine whether double lumen endotracheal tubes or~     bronchial blockers are superior to providing one lung ventilation during thoracic surgery.~   "
209920|NCT00813163|"~     The purpose of this study is to see the effect of PEP02 in the treatment of metastatic~     pancreatic cancer.~   "
209921|NCT00813150|"~     The purpose of this study is to compare bortezomib, dexamethasone and cyclophosphamide to~     bortezomib and dexamethasone alone for primary refractory or relapsed multiple myeloma.~   "
209922|NCT00813137|"~     FOLFOX4 plus Avastin has been suggested as firstline regimen for advanced colorectal cancer~     by NCCN, a new angiogenesis inhibitor, known as Endostar(Recombinant Human Endostatin),~     prolonged the overall survival, time to progression and improved response rate in metastatic~     lung cancer in a large phase III clinical trial in china, so we design this trial to evaluate~     the safty and efficacy of FolFox4 plus Endostar in patients with advanced colorectal cancer~   "
209923|NCT00813124|"~     The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to~     patients with CML after an donor stem cell transplant will increase the likelihood of~     achieving a complete remission of CML.~   "
209924|NCT00813111|"~     The purpose of this study is to provide a more effective postoperative method of pain control~     for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative~     pain management contributes to faster patient mobilization, shortened hospital stays, and~     reduced healthcare costs.~   "
209925|NCT00813098|"~     The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031~     versus a placebo control in subjects with non-constipating irritable bowel syndrome.~   "
209926|NCT00813085|"~     This study will evaluate whether the use of an electronic diabetes tracker by both patients~     and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with~     technology and health data privacy issues. As part of the study, the investigators will be~     able to test whether practices that use computers perform any better than practices using~     paper. The investigators also will be developing the first Canadian computerized chart~     summary for each patient that can be communicated securely in emergencies (the Emergency~     Health Record) and read by all current electronic systems.~   "
209927|NCT00813072|"~     The purpose of this study is to assess objective tumor response in the single agent treatment~     of PEP02, irinotecan, or docetaxel for locally advanced or metastatic gastric or~     gastroesophageal junction adenocarcinoma~   "
209928|NCT00813059|"~     Non-Arteritic Ischemic Optic Neuropathy (NAION) is a disease producing swelling of the optic~     nerve (the cable going from the eye to the brain) resulting in decreased vision. About 15%~     of patients will experience NAION in the second eye; many of these patients will be left~     legally blind.~      Currently, there is no treatment for NAION and for patients in whom the second eye becomes~     involved by the disease the outcome can be devastating.~      The investigators are conducting a study where the investigators will inject a medication~     into the involved eye of patients with NAION. This medication might decrease the swelling of~     the optic nerve and improve their vision in that eye.~   "
209929|NCT00813046|"~     The purpose of this study is to determine whether the oral administration of grass pollen~     peptides to treat allergic rhinitis is safe and well tolerated.~   "
209930|NCT00813033|"~     Parents need understandable information in order to make appropriate choices for their~     child's health care. This is especially true when making decisions about invasive medical~     procedures. Parents need to understand what will happen, the risks involved, how these risks~     will be managed and what other options they have before they can decide what is best for~     their child. The present proposal involves the creation of a novel patient decision aid about~     the gastro endoscopy procedure, called a scope. The purpose of the aid is to provide~     parents with information so they are able to discuss the options with their child's health~     care providers.~   "
209931|NCT00813020|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate whether~     differences exist between three different concentrations of the drug, NN9535, administered in~     healthy male subjects in equal doses.~   "
209932|NCT00813007|"~     The goal of this research study is to learn about quality of life, sexual functioning, and~     symptoms in women who have undergone abdominal radical trachelectomy for cervical cancer.~      This is an investigational study.~      Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.~   "
209933|NCT00812994|"~     Study intended to determine if there are baseline differences in serum neurosteroid levels~     and neurotrophic factor (BDNF) levels in healthy controls vs unmedicated depressed subjects,~     and whether the levels of these change with antidepressant treatment. Study also intended to~     determine if baseline neurosteroid/ BDNF levels, and the change in these levels with~     =treatment, are correlated with clinical antidepressant response to escitalopram (Lexapro).~   "
209934|NCT00812981|"~     This observer-blind study is designed to show the immunological non-inferiority of~     Thiomersal-free-processed pandemic influenza vaccine as compared to the~     Thiomersal-containing-processed pandemic influenza vaccine.~   "
209935|NCT00812968|"~     The purpose of this clinical experience study is to determine whether CC-5013 is safe and~     effective (to include studying the process by which a drug is absorbed, distributed,~     metabolized, and eliminated by the body [pharmacokinetics]) in Japanese subjects with low- or~     intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33)~     abnormality and symptomatic anemia.~   "
209936|NCT00812955|"~     The primary purpose of this study is to test the effect and safety of three different doses~     of ABT-143 compared to simvastatin in subjects with elevated levels of low density~     lipoprotein cholesterol (bad cholesterol) and triglycerides.~   "
209937|NCT00812942|"~     Adherence rate to screening colonoscopy (TC) in the average-risk general population is still~     unclear. Aim of this study was to compare the uptake of TC screening with that of fecal~     occult blood (FOBT) in the general population of different Italian areas.~   "
209938|NCT00812929|"~     This study is intended to determine the dose response and duration of action of GSK2190915 in~     mild asthmatic adult subjects who experience exercise-induced bronchoconstriction.~   "
209939|NCT00812916|"~     The purpose of this prospective observational study (registry) is to determine the acute~     success rate of a complex fractionated atrial electrogram (CFAE) guided ablation procedure~     using a dedicated software and to determine the functionality and performance of the CFAE~     software in patients with a type of persistent atrial fibrillation (AF) in routine clinical~     practice.~   "
209940|NCT00812903|"~     The purpose of this study is to determine the prevalence of neck and shoulder pain in Danish~     fighter pilots, helicopter pilots and helicopter flight crew and to evaluate the effect of a~     24 weeks exercise intervention for fighter pilots.~   "
209941|NCT00812890|"~     This study will examine the feasibility, practicality, utility and usability of a~     semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved~     by the food and drug administration (FDA) for both Professional (physician office) and~     over-the-counter (consumer) use. The study seeks to:~        1. Assess the correlation of this pregnancy test results with serum values (as distinct~          from urine) hCG.~        2. Assess whether or not time of day of urine collection has any impact on the outcome of~          the dBest test.~        3. Assess user comprehension of the pregnancy test, especially assessment of the result.~   "
209942|NCT00812877|"~     The purpose of this study is to determine if MTA or calcium hydroxide are more effective as~     pulp capping agents~   "
209943|NCT00812864|"~     The aim of the study is to determine blood concentration evolution of capecitabine and its~     active metabolites, in elderly patient 75 years and more.~   "
209944|NCT00812851|"~     Many patients with ALS experience cramps during the course of the disease. Frequently, cramps~     occur as the first symptom of the disease, months before the patients notice weakness and~     wasting. Cramp severity varies from mild, without affecting daily activities and sleep, to~     disabling, where almost any voluntary muscle activity induces long standing, severely painful~     cramping. ALS patients who smoke herbal cannabis (marijuana) or drink hemp tea report~     lessening of cramps and fasciculations. Although, various medications, such as magnesium,~     quinine sulfate, lioresal, dantrolene, clonazepam, diphenylhydantoin and gabapentin are used~     for the treatment of cramps in ALS so far, no medication has been of proven benefit. However,~     a recent pilot study with THC in ALS showed symptomatic effects in spasms, fasciculations,~     insomnia and appetite. The aim of the proposed study is to determine the tolerability, safety~     and efficacy of THC in the treatment of cramps in ALS. The hypothesis is that THC will lessen~     cramps in ALS.~   "
209997|NCT00812162|"~     The purpose of this study is to identify how adult men respond to a weight loss diet that~     includes pork and eggs and increasing the number of meals consumed throughout the day. This~     is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement).~   "
209945|NCT00812838|"~     Peyronie's disease is a condition in which a plaque, or hard lump, forms on the penis. It~     causes hardened tissue, pain, and an abnormal bending in the penis. These symptoms are more~     severe during an erection. Significant bending of the penis can result in pain, poor~     erections, and an inability to engage in sexual intercourse.~      This disease affects about 3% of the male population. The average age of onset of this~     disease is 57 years old. The cause of the disease is unknown. However, many believe that it~     may be due to trauma to the penis (such as injury or extremely vigorous sexual activity).~   "
209946|NCT00812825|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics (how the drug effects certain target sites of activity in the body) of~     escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will~     evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy~     volunteers.~   "
209947|NCT00812812|"~     This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial~     dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in~     children and adolescents with major depressive disorder (MDD) based on the change from~     baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind,~     placebo-controlled parallel-group study.~   "
209948|NCT00812799|"~     This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass~     pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.~   "
209949|NCT00812786|"~     The main objective is to develop pharmacokinetic methods for individual dose adjustment of~     the global immunosuppressive treatment (cyclosporine, tacrolimus, mycophenolate mofetil and~     everolimus, taking into account the pharmacokinetic interactions), in order to optimise the~     efficiency and reduce the potentially severe sides effects of these drugs.~      Forty five heart-transplant patients are to be included in this phase IV study to obtain a~     minimum of 10 patients treated with tacrolimus-mycophenolate, 10 with~     cyclosporine-mycophenolate and 20 with everolimus-cyclosporine.~      Ten to 11 blood samples will be collected within the 8 to 12 hours post-dose in each patient~     and the immunosuppressive drug concentrations will be measured by LC-MS/MS.~      The pharmacokinetic models and Bayesian estimators thus developed will provide tools for~     individual dose adjustment of immunosuppressive drugs simultaneously, at different~     post-transplant periods, using the area under the concentration-time curve (AUC) estimated~     using a limited number of time-points (2 or 3).~   "
209950|NCT00812773|"~     This study will evaluate the safety and effect of repeat oral doses of GSK2190915 on lung~     function in mild asthmatics using a number of clinical and biological markers of efficacy.~   "
209951|NCT00812760|"~     It is known that dopamine is a functional neuromodulator at several levels of the visual~     system. Dopamine seems to be involved in the organization of the ganglion cell and the~     bipolar cell receptive fields and modulation of physiological activity of photoreceptors.~     There is evidence for the functional significance of dopaminergic modulation of visual~     sensitivity in humans which confirms the hypothesis that dopamine plays an important role in~     retinal light adaptation as well as in motion and contrast sensitivity function. The~     electrophysiological effects of dopamine, various dopamine antagonist and levodopa in animals~     and humans have been investigated by means of visual evoked potentials and~     electroretinograms. The multifocal ERG technique, developed by Sutter et al. allows a rapid,~     simultaneous recording of focal ERGs from multiple retinal locations. Although this technique~     is relatively new, it has already provided insights into the mechanisms of retinal diseases~     (e.g. involvement of visual system in Parkinson disease), but until now there is no data on~     influence of dopaminergic substances on mERG.~   "
209952|NCT00812747|"~     The purpose of this multicentre prospective trial is to determine the incidence and risk~     factors for surgical wound infections. Also the investigators will evaluate consequences of~     wound infections to the patients, and extra costs caused by wound infections.~   "
209953|NCT00812734|"~     This cohort study aims to know the prevalence at 3 and 6 months after surgery, of persistent~     pain, as well as to describe the neuropathic features of this pain. It includes more than~     3000 patients scheduled for different types of surgery, some of them already known to induce~     persistent pain, some being frequent procedures with no additional data. Clinical and~     genetical risk factors will be searched.~   "
209954|NCT00812721|"~     Hypothesis is that tear substitutions cause blur after they are instilled. The investigators~     will use aberrometry as a measurement over time after a tear formulation is used and try to~     determine if there are any measurable change in higher order aberrations between different~     tear formulations and how long it takes to return to pre-instillation measurements thus~     providing information on duration of the tear drop. 4 commercially available dry eye~     artificial tears formulations will be used and preservative saline will act as a control. The~     study will be conducted on subjects that do not have clinical evidence of dry eye syndrome to~     focus the data on the blur effects of the tear substitutions.~   "
209955|NCT00812708|"~     The purpose of this study is to determine the safety and efficacy of Morcher Iris Diaphragms~     in the treatment of congenital and acquired aniridia. Morcher Iris Diaphragms are intraocular~     devices designed to provide an artificial pupil for patients suffering from partial or~     complete aniridia. These devices are constructed from clinical quality, ultraviolet~     light-absorbing, opaque black polymethylmethacrylate (PMMA). After surgical implantation,~     patients are monitored over the course of one year to measure any changes to visual acuity~     and improvements in light and glare sensitivity.~   "
209956|NCT00812695|"~     Obstructive sleep apnea (OSA) is an important cause of refractory hypertension but the impact~     of treatment with continuous positive airway pressure (CPAP) is not completely understood.~     The aim of this project is to study the effects of CPAP on blood pressure control and its~     influences on cardiac remodeling and arterial stiffness in patients with refractory~     hypertension and moderate or severe OSA.~   "
209957|NCT00812682|"~     This study will evaluate the perception of the physicians and the patients about the approved~     adjustable dosing of Symbicort® 160/4,5. Symbicort maintenance dose will be adjusted up and~     down within the approved dose range of 1x2 - 4x2 inhalations per day, to the level of asthma~     symptoms. Patients and physicians perception of this new dosing schedule will be evaluated by~     means of questionnaires completion and direct questioning.~   "
222948|NCT00640484|"~     The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be~     given once a day to patients with COPD in order for the effect to last for 24 hours.~   "
209958|NCT00812669|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Giving fludarabine~     together with cyclophosphamide and rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide~     and rituximab to see how well it works in treating patients with chronic lymphocytic~     leukemia.~   "
209959|NCT00812656|"~     The purpose of this study is to investigate changes in new plasma stroke biomarker panel in~     patients undergoing cardiac surgery with the use of cardiopulmonary bypass.~   "
209960|NCT00812643|"~     This is an explorative study and the scientific question to be investigated in this study is~     if AZD0837 and/or its metabolites AR-H069927XX and AR-H067637XX and other unknown metabolites~     are excreted into the bile.~   "
209961|NCT00812630|"~     This is a two-part trial assessing the effects of MENT on blood pressure. The first part of~     the trial is an open-label pilot study to verify the MENT gel formulation delivers~     appropriate drug levels. Upon confirming MENT serum levels are within the required range,~     clinical trial material will be produced and labeled. Consequently, the second part of the~     trial, the main study, will proceed approximately two months after the conclusion of the~     pilot study. The main study, is a randomized, double-blind, placebo-controlled study.~   "
209962|NCT00812617|"~     The purpose of the study is to determine the effect of a specific mineral water on serum~     lipid concentrations in healthy subjects.~   "
209963|NCT00812604|"~     The purpose of this study is to compare the effectiveness of using topical cream of Ping On~     Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and~     masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both~     Ping On Ointment and Vaseline are considered intervention.~   "
209964|NCT00812591|"~     The study seeks to use microdialysis and microperfusion techniques to assess the feasibility~     of combining insulin delivery and glucose sensing at a single subcutaneous tissue site.~   "
209965|NCT00812578|"~     The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of~     treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D~     insufficiency.~   "
209966|NCT00812565|"~     This study evaluated the effect of 6 or 12 infusions of different doses of octagam~     (intravenous immunoglobulin [IVIG]) 10% on the reduction of amyloid beta peptide (Aβ) in~     cerebral spinal fluid (CSF) and on the increase of Aβ in blood plasma in patients with mild~     to moderate Alzheimer's disease.~   "
209967|NCT00812552|"~     Multicenter, case-control study, to collect data regarding incidences of late and very late~     drug-eluting stent thrombosis with the aim of identifying trends and possible correlates of~     stent thrombosis.~   "
209968|NCT00812539|"~     Currently, diabetic patients who receive their care at the diabetes clinic self monitor their~     blood glucose using a portable glucometer, under the direction of care providers at the~     clinic. We propose to conduct a randomized controlled trial to examine the effect of the~     Diabetes Connected Health tool, which is a secure website shared between patients of Type-2~     Diabetes and their providers and displays (subjects') blood glucose values in graphical~     format. The study will be carried out through multiple primary care practices within the~     Partners/PCHI Network. We hypothesize that implementation of the Diabetes Connected Health~     Tool will result in overall better Diabetes Care, in terms of improved patient-provider~     interaction, and better patient satisfaction towards their care.~   "
209969|NCT00812526|"~     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in~     perfusion pressure. For a long time it had been assumed that the choroid is a strictly~     passive vascular bed, which shows no autoregulation. However, recently several groups have~     identified some autoregulatory capacity of the choroid. Choroidal autoregulation was first~     shown in a rabbit model where intraocular pressure (IOP) and arterial blood pressure could be~     varied independently. In these experiments regulation of choroidal blood flow was not only~     dependent on ocular perfusion pressure, but was also dependent on the value of IOP. This~     indicates that a myogenic mechanism contributes to choroidal autoregulation, because the~     regulatory capacity is dependent on the transmural pressure. In the model of myogenic~     autoregulation arterioles change their vascular tone depending on the pressure inside the~     vessel and outside the vessel. The present experiments are designed to test whether a~     myogenic mechanism may also be involved in choroidal autoregulation in humans. For this~     purpose the investigators perform experiments during which the IOP and the arterial blood~     pressure is increased. According to the myogenic theory of autoregulation one would expect~     stronger vasoconstriction at lower IOPs for the same increase in ocular perfusion pressure.~   "
209970|NCT00812513|"~     Platelet Derived Growth Factor (PDGF) is a potent mitogen for a wide range of cell types~     including fibroblasts, smooth muscle and connective tissue. Recombinant human platelet~     derived growth factor (R-Pdf/Gbb) has biologic activity similar to endogenous platelet~     derived growth factor (PDGF). Biologic activity of PDGF includes encouraging chemotaxis and~     proliferation of cells responsible for wound repair and it augments production of granulation~     tissue.~      The growth factor rhPDGF is found effective in patients having diabetic foot ulcer grade III~     and IV. The nature of wounds in the third degree burns is similar so far as healing process~     is concerned.~      The purpose of this study is to test the hypotheses that the application of R-Pdf/Gbb 0.01%~     gel on the third degree thermal and electrical burns will heal these wounds within 3 months~     and there will be improvement in general condition of the patients without any complications.~   "
209971|NCT00812500|"~     The purpose of this study was to assess the effect of age on the estimated average~     requirement and adequate allowance for dietary protein.~   "
209972|NCT00812487|"~     High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe~     hospital complications and even death.~   "
209992|NCT00812227|"~     The purpose of this study is to see whether we can predict which patients with depression~     will get better when we treat them with psychodynamic psychotherapy. We will use neuroimaging~     (a method of looking at brain activity) in this study. We want to see whether there are~     changes in the brains of patients receiving this type of therapy. We hypothesize that these~     changes may predict how well certain parts of the psychotherapy treatment process works.~   "
209973|NCT00812474|"~     Multiple Sclerosis (MS) is a common disease affecting 1/1000 Canadians. Cognition impairment~     is reported in 40-65% of patients and is socially and functionally disabling. Although~     multiple sclerosis is widely regarded as a white matter disease, cortical disease burden is~     increasingly emphasized. Studies confirm that gray matter (GM) disease is grossly~     underestimated by conventional MRI. Although the cause for MS is unknown vascular impairment~     is implicated in nerve cell death. Several studies have shown perfusion abnormalities in the~     central GM and white matter (WM) structure. Severity of perfusion reduction correlates with~     lesion load, atrophy, MS subtype and disease duration. Further extent of cortical atrophy~     correlates with neurocognitive impairment. We hypothesize that cortical perfusion is a marker~     of cortical disease severity and correlates with neurocognitive impairment. To show this we~     will measure regional cortical perfusion and regional brain and WM lesion volumes in 26~     predefined brain regions using a template developed for Alzheimer's disease. Regional~     perfusion will be correlated with neurocognitive tests validated for MS use. Patients will be~     divided into impaired and non impaired and perfusion compared controlling for known~     confounding factors. If confirmed cortical perfusion may be utilized as a surrogate marker of~     cognitive outcome in therapeutic studies.~   "
209974|NCT00812461|"~     The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in~     the treatment of alcohol dependence.~   "
209975|NCT00812448|"~     The purpose of this study is to evaluate the effects of catechin extracts containing mask on~     prevention of influenza infection.~   "
209976|NCT00812435|"~     This is a prospective, open label, randomized trial of 100 patients who present to the~     cardiac catheterization laboratory with an ST Elevation Myocardial Infarction for primary~     PCI. Patients may receive up-front unfractionated heparin or low molecular weight heparin,~     but not glycoprotein IIb/IIIa inhibitors or thrombolytics. Patients will be consented prior~     to the diagnostic catheterization and will be randomized once the patient is deemed amenable~     to PCI to receive eptifibatide or no eptifibatide just prior to or at the time of primary~     angioplasty. Patients will be randomized in a 1:1 fashion. All patients will be assessed for~     the primary endpoint of ST resolution at 60 minutes post PCI and followed throughout the~     duration of the hospitalization and up to 30 days for secondary endpoint evaluation.~   "
209977|NCT00812422|"~     The purpose of this study is to compare the safety and efficacy of dexibuprofen syrup and~     ibuprofen syrup in patients with fever due to common cold.~   "
209978|NCT00812409|"~     The purpose of this study is to identify the influence of resistance and aerobic exercise~     with different nutritional supplements in middle-aged men and women on various physiological~     measures. Throughout the study, the investigators examine body composition, body weight, food~     intake, fitness level, metabolism, and blood hormones.~   "
209979|NCT00812396|"~     This study will evaluate the ability of comparative proteomics to identify early biomarkers~     of muscle anabolism.~   "
209980|NCT00812383|"~     Single center randomized clinical trial, to evaluate the safety and efficacy of carotid~     artery stenting using the RX ACCULINK™ Carotid Stent System with RX ACCUNET™ Embolic~     Protection System or PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System~     using Angiomax (bivalirudin)versus heparin as the anticoagulant for treatment of occlusive~     carotid artery disease in low and high risk patient cohorts.~   "
209981|NCT00812370|"~     Thrombosis is a significant medical complication in children with chronic diseases. The~     currently utilized treatments have many drawbacks which can lead to poor outcomes. More~     modern therapies are available but have not been systematically tested in children. This~     study will determine whether one such medication, bivalirudin is a safer and more effective~     alterative.~      This study will monitor what effects the drug has upon the child's body and how the body~     processes the study drug (absorption, metabolism and elimination). The study will also~     evaluate the drug's effectiveness by following how long it takes to dissolve the clot. The~     safety issues being monitored relate to any observations of major or minor bleeding episodes~     after taking the drug, and/or any other side effects.~   "
209982|NCT00812357|"~     Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment~     of asthma in France and impact of a new therapeutic strategy on the compliance and control of~     asthma~   "
209983|NCT00812344|"~     This is an explorative study and the scientific question to be investigated is if the biliary~     excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by~     co-administration with ketoconazole~   "
209984|NCT00812331|"~     The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of~     TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never~     received treatment for their hepatitis C infection.~   "
209985|NCT00812318|"~     To evaluate the single dose relative bioavailability of GSK1265744 10mg administered in~     either oral solution fasted, two 5mg tablets fasted, or two 5mg tablets following a moderate~     meal.~   "
209986|NCT00812305|"~     Review differences between how a healthy person and how a person with liver problems handles~     the study drug.~   "
209987|NCT00812292|"~     The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg~     dose of TMC278 is absorbed into the body when administered as a solution, suspension,~     granules, or a tablet. In addition, the effect of each formulation of TMC278 will be~     evaluated in patients in the fasted and fed states and the palatability (how the drug tastes)~     of each formulation will be assessed. Finally, the safety and tolerability of each~     formulation of TMC278 will be assessed throughout the study.~   "
209988|NCT00812279|"~     The overall purpose of this clinical study conducted in confinement under well-defined~     conditions is to obtain initial data on the levels of human body exposure to selected smoked~     constituents of the SMAR cigarette.~      The main objective of this study is to compare the biomarkers of exposure to cigarette smoke~     constituents in smokers switching to SMAR and to biomarkers in smokers of conventional~     cigarettes (CC). The biomarkers of exposure will be measured in blood and urine samples~     collected from the subjects. Moreover, the biomarkers in subjects smoking conventional or~     SMAR cigarettes will be compared with those biomarkers in smokers who stop smoking for 5~     days. The short term safety of this new product will also be evaluated.~   "
209989|NCT00812266|"~     Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a~     combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell~     type.~   "
209998|NCT00812149|"~     This study intends to examine how a common genetic pattern affects thyroid function. Recent~     studies have demonstrated that a substance (enzyme) produced by a gene has an important role~     in controlling circulating thyroid hormone levels. A commonly found pattern in this gene~     exists in many individuals and might affect the function of the enzyme. These individuals~     need higher doses of thyroid hormone medication in certain situations (e.g. in the treatment~     of thyroid cancer after the thyroid gland has been removed) than those individuals without~     the variation.~      We intend to study this by looking at the response to a hormone-test in healthy volunteers~     with different genetic patterns.~      We plan to screen healthy volunteers using a blood test to identify their genetic pattern~     relating to the enzyme we are interested in. From this group, forty-five healthy volunteers~     will be recruited for the hormone-test. This test (called the TRH test) uses a hormone~     produced by the brain and stimulates the pituitary and thyroid gland. The response to this~     test will allow us to compare the function of the thyroid system in relation to the genetic~     pattern of the volunteer.~      We hypothesize that the stimulation of the thyroid hormone system will be decreased in~     volunteers with a specific genetic pattern and that these individuals will release less~     active thyroid hormone from the thyroid gland in response to the TRH test.~      This study will provide new information on the effect of a common genetic pattern on thyroid~     hormone function and will help us to better understand the way in which the thyroid hormone~     system operates. Ultimately, the results of this study might help to provide a more~     individualized therapy for patients in need of thyroid hormone replacement.~   "
209999|NCT00812136|"~     Asthma disproportionately affects minorities, but few studies have evaluated interventions to~     improve asthma outcomes in minority children.The purpose of the study is to determine whether~     Parent Mentors (PMs) are more effective than traditional asthma care in reducing minority~     children's asthma morbidity, costs, and use of services, while increasing families' quality~     of life and parental self-efficacy.~   "
210000|NCT00812123|"~     The main purpose of this study is to obtain preliminary information on the efficacy, safety~     and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF /~     steroid therapy, used in the prevention of acute rejection following renal transplantation.~   "
210001|NCT00812110|"~     We hypothesize that when offered influenza vaccine at little or no cost, in a setting where~     the value of the vaccine is connected to one's high risk child, vaccination rates for parents~     will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit~     environment.~   "
210002|NCT00812097|"~     The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's~     Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction,~     or revision. Safety information on the rate of capsular contracture, rupture, and infection~     will be collected, and used to help determine device safety.~      Approximately 1000 patients at approximately 60 medical centers across the United States were~     enrolled in this research study. These patients were implanted with silicone breast~     prostheses and will be monitored for 10 years to collect information on risks associated with~     the implant surgery as well as changes in the way these patients feel about themselves.~   "
210003|NCT00812084|"~     The purpose of this study is to collect additional data on hospitalized Community-Acquired~     Pneumonia (CAP) on health states, health outcomes and on (health) resources and estimate the~     differences in the quality of life and resources of elderly persons with and without CAP.~   "
210004|NCT00812071|"~     Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in~     best group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.~   "
210005|NCT00812058|"~     The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms~     of bipolar I depression and to make sure it is safe in humans.~   "
210006|NCT00812045|"~     The purpose of this study is to determine the effect of AZD1236 in patients with cystic~     fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4~     weeks.~   "
210007|NCT00812032|"~     The efficacy of low dose aspirin appears to be substantially lower in diabetic patients,~     compared to patients without diabetes. The aim of the investigators study is to test the~     laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The~     investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320~     mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve~     the response to aspirin.~   "
210008|NCT00812019|"~     The aim of the present dose ranging study is to evaluate the safety, tolerability and~     immunogenicity of two doses of twelve different formulations of a Cell Culture-Derived H5N1~     Subunit Influenza Virus Vaccine, adjuvanted with MF59 or non-adjuvanted, given three weeks~     apart and followed by a booster dose after 12 months in healthy adults 18 to 40 years of age.~   "
210009|NCT00812006|"~     This study will provide additional efficacy data for rizatriptan when used for an acute~     migraine attack in patients already taking topiramate for migraine prophylaxis.~   "
210010|NCT00811993|"~     This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct~     standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with~     advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets~     of patients who are eligible for the study: untreated, treated and requiring further~     treatment, or treated and failed and for whom adding R1507 represents a suitable treatment~     for their disease. All regimens will first test doses of R1507 which are less than the~     maximally administered dose, and if tolerated, the dose will be escalated in subsequent~     patients. The anticipated time on study treatment is until disease progression, and the~     target sample size is 100-500 individuals.~   "
210011|NCT00811980|"~     We will determine if linezolid inhibits cellular activation and production of~     pro-inflammatory cytokines, providing mechanistic rationale for its clinical efficacy and the~     justification for further investigations in S. Aureus sepsis.~   "
210012|NCT00811967|"~     The objective of the study is to evaluate the superiority of treatment with PegIntron and~     Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and~     type C compensated cirrhosis. Subjects will be randomized in a ratio of 2:1 (Treatment Arm to~     Control Arm). Subjects in the Treatment Arm will receive combination therapy with PegIntron~     and Rebetol for 48 weeks; then will enter a 24-week post-treatment Follow-up. Subjects who~     have detectable Hepatitis C Virus-RNA at Treatment Week 24 will discontinue treatment and~     enter Follow-up.~   "
210013|NCT00811954|"~     The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected~     patients who have never received anti-HIV therapy be treated with a triple drug regimen. The~     most commonly prescribed and successful regimen contains the medication efavirenz (EFV).~     However, this regimen may not be an option for everyone, hence alternative regimens are~     needed.~      This study was designed to look at how well different combinations of anti-HIV drugs work to~     decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in~     people who have never received anti-HIV therapy. This study also examined drug tolerability~     and safety for the various drug combinations.~   "
210014|NCT00811941|"~     The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in~     patients with alcohol dependence.~   "
210015|NCT00811928|"~     A randomized, open label parallel controlled, multicenter study to evaluate safety and~     efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic~     patients for prevention of invasive fungal infection~   "
210016|NCT00811915|"~     The use of tacrolimus in the long term as part of the immunosuppressive regimen after~     transplantation is associated to complications such as chronic nephrotoxicity, impaired~     glucose metabolism (diabetes mellitus) and an increase of the incidence of neoplasia. The~     conversion from a tacrolimus based therapy to a sirolimus based therapy associated with~     mycophenolate mofetil could improve the incidence of such complications. The aim of this~     study is to assess the risk/benefit ratio of this switch performed in stable renal transplant~     recipient between 12 months and 36 months after transplantation. The incidence of a composite~     endpoint (worsening of GFR evaluated by MDRD formula, incidence of cancer and diabetes) will~     be assessed 24 months after conversion.~   "
210017|NCT00811902|"~     The primary objective is to assess the activity of nerispirdine in improving the ability to~     walk, in patients with multiple sclerosis (MS).~      Secondary objectives:~        -  To assess other measures of walking ability, tiredness, and lower limb muscular~          strength, spasticity, clinical assessment by subject and clinical assessment of change~          by the Study Investigator~        -  To assess the safety and tolerance of nerispirdine~        -  To evaluate the pharmacokinetics (PK) parameters of nerispirdine~   "
210018|NCT00811889|"~     This study assesses the effects of bardoxolone methyl (RTA 402) in patients with type 2~     diabetes and chronic kidney disease.~   "
210019|NCT00811876|"~     Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of~     treatment~   "
210020|NCT00811863|"~     The objective of this study is to prospectively monitor the incidence of adverse drug~     reactions, specifically NSF during routine use of gadoversetamide in a large number of~     patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or~     end-stage renal disease requiring dialysis (eGFR <30).~   "
210021|NCT00811850|"~     A 10 week evaluation, crossover design study including a 3 week washout period between~     treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate~     0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol~     maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.~   "
210022|NCT00811837|"~     Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and~     leads to deterioration of quality of life. An injury or wound can lead to long term changes~     in the nervous system that make the skin more sensitive at and near the injury; this is~     termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the~     synaptic interaction between neurons.~      Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in~     animal studies the investigators have discovered previously unrecognized effects of opioids.~      UV-B irradaition of the skin of the thigh is an established model of priamary and secondary~     hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an~     ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human~     volunteers in a double blind cross-over prospective active placebo controlled clinical trial.~   "
210023|NCT00811824|"~     This study is testing the effects of exercise and dietary change on weight reduction and~     biological markers associated with breast cancer risk in breast cancer survivors of Hispanic~     or African descent (n=45). This is a randomized, crossover pilot and feasibility study to~     test the effects of a 30-minute circuit-based exercise program that combines resistance~     training with aerobic exercise in conjunction with a low-fat calorie reduced diet.~     Participants will be randomized to either an immediate 6-months of exercise and dietary~     change, or a delayed group who will begin their exercise and dietary change program 6-months~     after the study begins. Participants in the immediate group will be followed for an~     additional 6-months in order to evaluate adherence to the exercise and dietary change~     recommendations. Participants in both groups will exercise at a neighborhood Curves® facility~     at least 5 times per week for six months and will participate in a series of nutrition~     education classes.~   "
210024|NCT00811811|"~     This randomized controlled trial will examine whether behavioral neurocardiac training with~     heart rate variability biofeedback (BNT) augments reduction in ambulatory daytime and 24-hour~     SBP, DBP and PP, in comparison to an active control intervention (AC, autogenic relaxation~     training), among subjects diagnosed with hypertension, and following adjustment for~     medications. In addition, the independent association between the BNT and AC interventions on~     vagal-heart rate modulation and baroreflex sensitivity will be evaluated during a~     standardized assessment protocol of mental stress testing. This study extends a previous~     trial conducted at the UHN, in which we reported that the biofeedback intervention~     independently augments vagal-heart rate modulation, while reducing symptoms of stress and~     depressed mood, among subjects diagnosed with cardiovascular disease. Exploratory features of~     this trial will examine the association between ambulatory blood pressure, vagal-heart rate~     modulation, baroreflex sensitivity, and markers of inflammatory activity.~   "
210025|NCT00811798|"~     This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus~     (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses~     of commercially available HPV vaccine before they are 25 years, and were placebo recipients~     in the primary study (NCT00306241).~   "
210075|NCT00811148|"~     The purpose of this research study is to collect and store brain tumor tissue samples for~     future research. The samples will become part of the University of Florida Brain Tumor Tissue~     Bank/Florida Center for Brain Tumor Research. The goal is to find improved treatments and~     cures for brain tumors.~   "
210026|NCT00811785|"~     Menkes disease and occipital horn syndrome are two forms of copper deficiency that must be~     diagnosed and treated very early in life to prevent serious developmental problems. However,~     these and other forms of copper deficiency are not very well understood, and further research~     is needed to determine whether certain treatments are useful in treating copper deficiency.~     One such treatment is copper histidine, a copper replacement that can be injected directly~     into the body to avoid absorption through the gastrointestinal tract. This study will~     investigate the effectiveness, side effects, and dosage of copper histidine treatment for~     patients with copper deficiency. It will also collect medical history information from~     patients to allow researchers to study possible genetic and nongenetic origins of copper~     deficiency.~      This study will include 100 subjects, all of whom will be children and adults who have been~     diagnosed with Menkes disease, occipital horn syndrome, or other unexplained copper~     deficiency.~      Patients will receive a prescribed dose of copper histidine, which will be administered daily~     as an injection.~      During the study, patients will be admitted to the NIH Clinical Center on an outpatient basis~     to evaluate their response to the copper histidine treatment. These evaluations will take~     place every 8 months, with a final evaluation performed after 3 years of treatment. During~     the outpatient visits, patients will be required to give blood and urine samples for testing~     and undergo ultrasound testing. They will also undergo brain MRI scans at the initial visit~     and at the 16-month and 36-month visits. Patients who agree will give additional blood~     samples for genetic research purposes.~   "
210027|NCT00811772|"~     Stenosis of the coronary arteries may be treated by balloon dilatation followed by the~     implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with~     bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of~     myocardial infarction (MI) and death. Drug eluting stents (DES)release drugs to the vessel~     wall that delay or inhibit the process of restenosis. Some reports have found that DES are~     associated with risk of acute stent thrombosis, MI and death. The precise magnitude of this~     risk is not known. Current evidence is therefore insufficient to balance the long-term risk~     and benefit of BMS vs DES.~      The purpose of this trial is to compare the long-term effects on MI and total mortality of~     BMS vs DES. The trial will recruit 8000 patients from 8 Norwegian hospitals. The patients~     will be randomized to treatment with BMS or DES. Clinical events will be registered for 5~     years after treatment. The study hypothesis is that there is no difference in the risk of~     death or myocardial infarction after treatment with BMS vs DES. The trial is initiated and~     run by university researchers and is sponsored by not-for-profit organizations.~   "
210028|NCT00811759|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as temozolomide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving sorafenib together with~     temozolomide may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib~     together with temozolomide in treating patients with stage III or stage IV melanoma.~   "
210029|NCT00811746|"~     This study is being conducted to determine if eszopiclone is as effective as ramelteon when~     used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat~     sleep apnea.~   "
210030|NCT00811733|"~     Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic~     Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a~     non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients~     with Waldenstrom's Macroglobulinemia (WM).~   "
210031|NCT00811720|"~     The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in~     the treatment of alcohol dependence.~   "
210032|NCT00811707|"~     The failure in indwelling epidural catheter for a parturient might cause an anesthetic~     difficulty. Furthermore, no one can predict the accuracy of needle placement prior to skin~     puncture with any of landmark-based technique. This may result in multiple trying attempts at~     needle puncture, pain and discomforts of patients and poor patient satisfaction. The aim of~     this study was to explore the difference of epidural space between parturient and~     non-pregnant women by assessing ultrasound image.~   "
210033|NCT00811694|"~     A variety of studies demonstrate that ocular blood flow is altered in glaucoma. Various~     animal and human studies have shown an increase in retinal and optic nerve head blood flow in~     response to diffuse luminance flicker. Based on studies with ERG, this effect has been~     attributed to augmented activity in the retinal ganglion cells and associated axons~     indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a~     variety of studies have confirmed these effects, the knowledge about this coupling in the~     retina of patients with glaucoma is sparse.~      Recently the investigators could show that flicker induced vasodilatation is blunted in~     patients with open angle glaucoma. However, the investigators results are limited by the fact~     that only data about retinal vessel diameters, not blood flow per se, are available. The~     further development of the investigators current flicker stimulation technique now allows us~     to determine blood flow velocity during flicker stimulation. Thus, in the current study, the~     investigators set out to determine whether this blood flow response is impaired in patients~     with glaucoma as compared to those in healthy volunteers and whether this is related to~     altered neural activity.~      The study objective was, to investigate whether the blood flow response to flicker~     stimulation is altered in patients with glaucoma.~   "
210045|NCT00811538|"~     The clinical and radiological data of patients with an acute ischemic stroke treated with~     intravenous thrombolysis (IVT) or intraarterial thrombolysis (IAT) in a Swiss stroke unit are~     assessed in a Swiss Multicenter Thrombolysis Registry. Like in clinical routine, a clinical~     evaluation takes place in a 3-months follow-up. Furthermore quality of life is assessed with~     a standardized questionnaire. The aim of the registry is to compare the safety and efficacy~     of IVT and IAT in patients with acute ischemic stroke. The registry also helps to improve~     in-hospital-management of stroke patients.~   "
210074|NCT00811161|"~     The primary objective of this study is to Evaluate the effectiveness of treatment of wrinkles~     or damaged skin with the Airgent device.~      The secondary objective of this study are to:~        -  Evaluate subjects' satisfactory of the treatment.~        -  Demonstrate the safety of the Airgent treatment by evaluation of adverse events.~   "
210034|NCT00811681|"~     Friedreich's ataxia (FA) is a rare progressive neurological disorder affecting approximately~     1/30, 000 individuals. No treatment is presently available to counteract the~     neurodegeneration of this extremely severe disease.~      Pioglitazone, a well known PPAR gamma (peroxysome proliferators-activated receptor gamma)~     ligand induces the expression of many enzymes involved in the mitochondrial metabolism,~     including the superoxide dismutases. This agent may be therapeutic by counteracting the~     disabled recruitment of antioxidant enzymes in FA patients. This potential neuroprotective~     agent crosses the brain blood barrier in human.~      Primary objective: To explore the effects of Pioglitazone on neurological function in FA~     patients. We expect neurological benefits taking into account the natural course of the~     disease.~      Population: Subjects for this study will be limited to patients not older than 25 years~     Methodology: Prospective, randomized double-blind trial of Pioglitazone versus placebo in FA~     patients. Patients will be treated two years and will undergo clinical exams and testing~     during three days each six months at the clinical investigation centre.~   "
210035|NCT00811668|"~     In patients with underlying heart diseases like hypertensive heart disease, coronary heart~     disease or dilative cardiomyopathy obstructive sleep-apnea, central sleep-apnea and~     Cheyne-Stokes-respiration are common finding in polysomnography.~      In a lot of these patients it is neither a purely obstructive sleep-apnea syndrome nor a~     complete Cheyne-Stokes-respiration but a combination of both sleep related respiratory~     disturbances.~      Previous studies showed an improvement of the central respiratory disorder, for example~     Cheyne-Stokes-respiration, under continuous positive pressure breathing (CPAP) and an~     improvement of the left ventricular pump function. (Naughton 1995, Tkacova 1997).~      However, the recently published CanPAP study could not prove any improvement in the mortality~     among CPAP therapy patients in comparison to the optimal medical treatment, although under~     this therapy, the number of breathing disturbances, the oxygen saturation at night and the~     ejection fraction of the left ventricle showed a significant improvement.(Bradley 2005)~      Earlier studies proved the adaptive servo ventilation to be an effective therapy for patients~     with central sleep-apnea and Cheyne-Stokes-respiration respectively. (Teschler 2001)~     Teschler's study showed that the adaptive servo ventilation therapy with a reduction of~     central sleep apnea down to 10/hours succeeded. With the SOMNOvent CR a new therapy-algorithm~     has been developed for the adaptive servo ventilation in patients with obstructive sleep~     apnea and Cheyne-Stokes-respiration with underlying heart disease. In the first validation~     study this therapy was very effective and presented only few adverse effects in the patients.~     (Galetke 2007)~      The goal of the study was to compare this new therapeutic option (SOMNOvent CR) with the~     established method of continuous positive airway pressure (CPAP) in patients with combination~     of obstructive sleep-apnea syndrome and Cheyne-Stokes-respiration with underlying heart~     disease.~   "
210036|NCT00811655|"~     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating~     patients with brain metastases.~   "
210037|NCT00811642|"~     The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of~     a 12-week treatment with Posaconazole Oral Suspension in participants with IFI~   "
210038|NCT00811629|"~     sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel~     marker of alveolar epithelial type I cell injury, but is also involved in acute systemic~     inflammation. The purpose of this observational prospective study is to determine whether~     sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during~     ALI/ARDS, regardless of associated severe sepsis or septic shock.~   "
210039|NCT00811616|"~     OBJECTIVES:~      The primary objective of this study is to assess the safety and efficacy of the Supralimus -~     Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease.~      STUDY DESIGN:~      This is a single centre, prospective study. Approximately 105 patients were enrolled in the~     study. Patients were followed for twelve months post-procedure. All patients were to have a~     repeat angiography at 8 months.~      STUDY POPULATION:~      The study population consisted of approximately 105 patients with de novo native vessel~     obstructive coronary artery disease with no specific criteria. Patients from the daily~     practice were included. Patients had to meet all eligibility criteria for inclusion into the~     study.~      ENDPOINTS:~      The primary safety endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at~     30 days.~      The primary efficacy endpoint is the in-stent binary restenosis rate at 8-month follow-up~     determined by off-line Quantitative Coronary Angiography.~      The following secondary efficacy endpoints were assessed~        -  Angiographic success~        -  Procedure success~        -  Quantitative Coronary Angiography derived vessel parameters in-stent and 5 mm proximal~          and 5 mm distal from the edge of the stent: acute gain, MLD, % DS, late loss, mean~          diameter. In-stent pre-, post and at 8-month follow-up.~        -  Clinically justified Target Lesion Revascularization (TLR) at 12 months~      The following secondary safety endpoints were assessed:~        -  MACE until 12 months~        -  Device related SAEs until 12 months~        -  Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after~          30 days until 12 months)~   "
210040|NCT00811603|"~     The purpose of this study is to evaluate the rates of maternal and neonatal infectious~     morbidity in gravid patients undergoing cesarean delivery. Specifically, the investigators~     are examining whether the timing of antibiotic administration has any effect on rates of~     maternal and neonatal infections, neonatal sepsis work-up and length of hospital stay.~   "
210041|NCT00811590|"~     Pilot study, Open-label, Phase II study of Everolimus.~      Objective:~      To determine if Everolimus can diminish large gastrointestinal polyps in patients with~     Peutz-Jeghers Syndrome.~      Methodology:~      Polyp size and number will be compared to baseline by FDG-PET and CT and 12 months after~     treatment with Everolimus. Since this is a pilot study, the polyps prior to treatment will~     serve as the controls.~   "
210042|NCT00811577|"~     The purpose of this study was to determine the safety of AZX100 Drug Product and to determine~     whether it was effective in preventing or reducing scars that were made from trocars~     following arthroscopic shoulder surgery.~   "
210043|NCT00811564|"~     A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2%~     brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin~     analogue in glaucoma or ocular hypertension subjects~   "
210044|NCT00811551|"~     zWedge is a clinical feasibility IDE study. The objective is to characterize the relationship~     between intra-thoracic impedance measurements obtained from a CRT-D device and pulmonary~     capillary wedge pressure (PCWP) measured via a right heart catheterization (RHC) acutely and~     over time.~   "
210071|NCT00811200|"~     The purpose of this study is to demonstrate a statistically significant improvement of visual~     acuity after treatment using either Lucentis® or Triamcinolone® compared to no treatment, in~     patients with radiation retinopathy.~   "
229790|NCT00548925|"~     The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose~     of an investigational product in subjects with diabetic neuropathy~   "
210046|NCT00811525|"~     The Contour Profile Gel Continued Access Study is designed to demonstrate safety of Mentor's~     Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction,~     or revision. Safety information on the rate of capsular contracture, rupture, and infection~     will be collected, and used to help determine device safety.~      With approval of MemoryShape™ Medium Height, Moderate Profile (CPG 321) Breast Implants on~     June 14, 2013, CPG CA Study subject enrollment has closed and the study has converted to a~     post approval study for this style.~   "
210047|NCT00811512|"~     The goal is to describe the fundamental aspects of fundoscopic eye in patients with~     microphthalmia~   "
210048|NCT00811499|"~     This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the~     effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating~     ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients~     from the US, Canada, Poland and Hungary will be enrolled in this study.~   "
210049|NCT00811486|"~     Secondary hyperaldosteronism and the non-osmotic release of arginine vasopressin (AVP) are~     the major factors in sodium and water retention in pulmonary arterial hypertension with right~     ventricular failure. Natriuretic doses of mineralocorticoid antagonist and aquaretic doses of~     V2 receptor antagonist will attenuate the sodium and water retention respectively, and be~     associated with clinical improvement.~   "
210050|NCT00811473|"~     The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine~     XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating~     children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with~     placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).~   "
210051|NCT00811460|"~     This crossover study will assess the effect of 2 doses of Taspoglutide on first- and~     second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a~     continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide~     300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or~     b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be~     crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive~     placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion~     patterns will be assessed. The anticipated time on study treatment is <3 months, and the~     target sample size is <100 individuals.~   "
210052|NCT00811447|"~     Primary objective:~      To detect a statistically significant increase in time to progression (TTP) of disease for~     the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF])~     relative to the control group (Cisplatin combined with 5-fluorouracil[CF])~      Secondary objectives:~        -  To detect a statistically significant increase in overall survival (OS) for the test~          group relative to the control group.~        -  To compare response rate (RR), time to treatment failure (TTF), duration of responses,~          safety profiles, quality of life (QOL), and disease-related symptoms.~   "
210053|NCT00811434|"~     Pediatric patients with chronic liver disease may have Minimal Hepatic~     Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological~     function.By utilizing cognitive and developmental testing we will determine if patients have~     MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a~     washout period with no treatment. At this time patients are re-tested and then begin another~     three month period switching to the opposite treatment of first 3 months.Final~     cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.~   "
210054|NCT00811421|"~     The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to~     Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the~     prevention of malaria effects on the mother and her infant.~   "
210055|NCT00811408|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as cidofovir may~     make tumor cells more sensitive to radiation therapy. Giving cidofovir together with~     radiation therapy and chemotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in~     treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who are~     receiving chemotherapy together with radiation therapy.~   "
210056|NCT00811395|"~     The primary objective was to evaluate the long-term safety and tolerability of teriflunomide~     when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with~     multiple sclerosis [MS] with relapses.~      Secondary objectives were to evaluate the long-term effect on relapse rate, disability~     progression and Magnetic Resonance Imaging [MRI] parameters.~      This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865)~     studies. Participants who successfully completed the initial study were offered to continue~     their treatment (same compound, same dose) for 24 additional weeks.~   "
210057|NCT00811382|"~     EffecT is a prospective, randomized multicenter study to assess whether management of atrial~     fibrillation (AF) as well as the early optimization of cardiac resynchronization therapy~     (CRT) via Home Monitoring decreases mortality and morbidity compared to conventional~     treatment in subjects with a standard indication for CRT with Implantable Cardioverter~     Defibrillator (ICD) backup and AF.~   "
210058|NCT00811369|"~     The purpose of this study is to evaluate whether the combination of fulvestrant and ZACTIMA,~     versus fulvestrant plus placebo, results in a significant decrease in the bone marker,~     urinary N-Telopeptide (NTx) in postmenopausal women with bone only, or bone predominant,~     hormone receptor-positive metastatic breast cancer. A significant decrease will be defined as~     a > 30% reduction in urinary NTx level from baseline.~   "
210059|NCT00811356|"~     The purpose of this study is to determine if the study drug (antimalarial medication) is safe~     when given to healthy subjects as a single dose or as repeated doses, to understand the~     effect of food on single doses of study drug and to determine if the study drug has an effect~     on other approved medications such as rosiglitazone and rosuvastatin.~   "
210072|NCT00811187|"~     The purpose of this study is to determine the effectiveness of paracervical block for pain~     relief in office hysteroscopy - particularly with the placement of the Essure device.~     Subjects will be randomized to receive either paracervical block or saline, and will have~     pain assessments performed throughout the procedure. Subjects and physicians will be blinded~     to group assignments.~   "
210060|NCT00811343|"~     Tuberculosis is a current infection during anti TNF therapy. After infectious contact, some~     patients will develop tuberculosis and some will only be infected without symptoms, they have~     Latent Tuberculosis Infection (LTBI) wich can reactivate later. In order to prevent this~     tuberculosis reactivation, LTBI diagnosis screening is preconised in patients who need anti~     TNF therapy. This diagnosis is made till now by the tuberculin skin test (TST) but this test~     is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific to MTB infection are~     now available.~      The primary endpoint of this study is the evaluation of the theoric therapeutic impact of the~     use of new tests for diagnosis of LTBI in patients before anti TBF therapy~   "
210061|NCT00811330|"~     The purpose of the study is to see if statin therapy will optimize myocardial response to~     cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS)~     (Phase I) and optimize left ventricular reverse remodeling following AVR (Phase II).~     Preliminary evidence indicates that perioperative statin therapy reduce mortality and~     morbidity following cardiac surgery. Pleiotropic effects of statins may induce myocardial~     preconditioning and optimize myocardial and systemic responses to cardiopulmonary bypass~     during AVR. Furthermore statin therapy after AVR may contribute to an optimal left~     ventricular reverse remodeling.~   "
210062|NCT00811317|"~     We hypothesize that our integrated closed-loop glucose-control system can provide effective,~     tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the~     feasibility of closed-loop BG control.~   "
210063|NCT00811304|"~     Specific Aim: The purpose of this study is to determine if labor epidural placement using~     real-time (concurrent) ultrasound guided placement is superior to the conventional standard~     epidural technique without the use of ultrasound at Magee-Womens Hospital.~      Hypothesis: Ultrasound guided labor epidural placement in real-time will decrease the~     traditional epidural failure rate from 5% to 1%.~   "
210064|NCT00811291|"~     Vitamin-B and Folic intake of Kindergarten kids in Germany is only 50-70% of the official~     recommendations. In studies with adults it has been found that for example providing people~     suffering from Alzheimer´s disease improved their mental and cognitive abilities when~     provided with a high intake of these vitamins.The hypothesis is, that kindergarten kids, 4-6~     years of age, could also improve mentally from a recommended intake of B-vitamins and Folic~     Acid.~        1. screening study: The urine of 1200 kindergarten kids will be analyzed for metabolites of~          these vitamins, and the 250 kids with the lowest results will be invited for a~          randomized double blind intervention study.~        2. intervention study: Participating kids will get an one hour mental and cognitive testing~          before and after the intervention. The intervention will be one portion of the~          recommended dosage of a vitamin B complex and folic acid , given in a drink (milk, tea,~          etc). The assumption is, that the treatment group will perform better than the placebo~          group in the second test phase.~   "
210065|NCT00811278|"~     Inhaled corticosteroids are widely used as the primary therapy for asthma, which affects~     approximately 20 million people in the United States. While many patients respond to~     corticosteroid therapy, as many as 25-30% of patients with severe asthma have asthma that is~     difficult to treat or steroid insensitive. Predictive biomarkers for the rapid identification~     of patients with asthma who will achieve adequate control of their symptoms with inhaled~     corticosteroids has the potential to significantly improve asthma management. This proposal~     is based on the hypothesis that alterations in gene expression in epithelial cells of the~     buccal mucosa can be used as a reliable biomarker to predict corticosteroid response in~     patients with asthma. The goals of this proposal will determine if gene expression in~     epithelial cells of the buccal mucosa from patients with asthma is in concordance with gene~     expression profiles that have been identified through more invasive sampling techniques of~     the airway epithelium of asthma patients. The Specific Aims of this proposal are to 1)~     investigate the level of variability in gene expression of a subset of inflammatory markers~     in buccal epithelium from adult patients with asthma. Aim 1 will be carried out by collecting~     buccal samples from three cohorts of subjects (18-55 years of age) from the Pulmonology and~     Allergy Clinics at Truman Medical Center during regularly scheduled outpatient visits as~     follows: 1) healthy control adult subjects (n=10), 2) patients with asthma treated only with~     a short-acting beta2-agonist (SABA, n=10), and 3) patients with asthma treated with low-dose~     ICS (n=10). Relative gene expression of inflammatory markers will be determined using~     quantitative RT (reverse transcription)-PCR and variability in gene expression will be~     determined within and between the three cohorts. Data from the pilot studies described in~     this proposal will aid in the determination of appropriate study population sizes for future~     investigations with the long-term objective to use changes in gene expression (in buccal~     epithelial cells) as a dynamic biomarker for determining corticosteroid response in patients~     with asthma.~   "
210066|NCT00811265|"~     Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.~   "
210067|NCT00811252|"~     To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of~     depression by means of the change from baseline in the 24-item Hamilton Depression Scale~     (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.~   "
210068|NCT00811239|"~     In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by~     Bungarus multicinctus. Hitherto, these victims have received supportive care only. The aims~     of this study were to assess the possible efficacy and side effects of a newly produced~     antivenom.~   "
210069|NCT00811226|"~     The purpose of this study is to determine the efficiency of Olmesartan medoxomile (OLMETEC®)~     alone or in combination with hydrochlorothiazide (OLMETEC PLUS®) in the reduction of arterial~     blood pressure in patients with light to moderate hypertension, and to evaluate the~     percentage of patients that reach treatment goals using this antihypertensive regimen.~   "
210070|NCT00811213|"~     The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway~     pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns~     that differentiate between sleep and wake. Upon sensing that the patient is awake the device~     is able to reduce positive airway pressure PAP aiming to improve patient comfort which should~     result in more consolidated sleep. This study will investigate Obstructive Sleep Apnea (OSA)~     and a automatically Adjusting Positive Airway Pressure (APAP) device with new technology~     called SensAwake™. This requires experimental confirmation in a randomised controlled trial.~     Double−blind randomised crossover trial comparing WASO on standard APAP with WASO using APAP~     modified by the addition of the SensAwake™ modification on consecutive nights in participants~     with moderate−to−severe OSA.~      A total number of 45 participants will be recruited from an OSA population, aged 18−65.~     Participants will consist of male and female patients diagnosed with moderate−severe OSA~     (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants,~     according to the protocol approved by the HREC, providing written informed consent will be~     enrolled into the study. Patients will be enrolled sequentially according to the~     randomisation list. Patients will be randomised to APAP or APAP with the addition of the~     SensAwake™ modification. The investigator and study staff will be blinded to the treatment of~     any participant.~   "
210076|NCT00811135|"~     This single arm study will assess the efficacy and safety of Avastin in combination with~     Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent~     or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin~     (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of~     subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and~     Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The~     anticipated time on study treatment is until disease progression, and the target sample size~     is <100 individuals.~   "
210077|NCT00811122|"~     Alzheimer's disease (AD) is characterized by neuritic plaques, neurofibrillary tangles, and~     neuronal cell loss. Amyloid plaques are believed to play an integral role in AD. Elevated~     levels of Aβ in the brain are correlated with cognitive decline.~      There are no approved ways to measure amyloid load in humans. Several compounds are under~     investigation. All of these compounds use radioactive chemical tags for positron emission~     tomography (PET) imaging. The most promising compound is 11C-PIB, or Pittsburgh Compound-B.~     This compound can be injected and a PET scan performed. This allows doctors to see the~     amyloid plaques in the brain, and to use this information to look at other types of dementia~     to see if there are differences and/or similarities in the plaques.~      We will recruit a total of 30 subjects, 10 from each of the following three diagnostic~     categories: frontotemporal dementia (FTD), Alzheimer's disease, and normal volunteers. All~     subjects will be given an [18F]fluorodeoxyglucose or FDG-PET scan (if they haven't had one in~     the past) and a PIB-PET scan.~      The overall objective of this project is to study the biodistribution of 11C-PIB using PET~     imaging in normal elderly volunteers and relevant patient groups.~   "
210078|NCT00811109|"~     The purpose of this randomized controlled study is to compare the effects of different new~     dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis~     in critically ill patients with acute kidney injury.~   "
210079|NCT00811096|"~     Assess the efficacy of 2 grams of tinidazole given for 5 days with standard dose chloroquine~     to achieve radical cure of Plasmodium vivax within a 90 day follow-up period sufficient to~     justify an IND and formal phase II evaluation.~   "
210080|NCT00811083|"~     Many children with autism have a reduced level of glutathione and a reduced ability to~     excrete mercury, resulting in elevated levels in their bodies as demonstrated by blood, hair,~     provoked urine, and baby tooth testing. Our earlier studies have demonstrated that DMSA, an~     FDA-approved medication for treating lead poisoning in children, is effective in increasing~     excretion of mercury and other toxic metals. Based on many clinical reports, we hypothesize~     that a 3-month treatment with glutathione and DMSA will result in a reduction of autistic~     symptoms in some children with autism.~   "
210081|NCT00811070|"~     This is a two-part safety and efficacy study of SKI-606 in subjects who have Philadelphia~     chromosome positive leukemias (CML). Part 1 will be a dose-escalation study, in which an~     escalating dose of SKI-606 (Bosutinib), up to 600 mg, will be studied in subjects with~     imatinib resistant/refractory or imatinib intolerant chronic phase CML. Part 2 will evaluate~     the safety and efficacy of the maximum tolerated dose (MTD) of SKI-606 (Bosutinib)identified~     in Part 1 of the study.~   "
210082|NCT00811057|"~     Preterm birth is the most common and costly complication in obstetrics. It complicates up to~     11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop~     preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is~     used by about 95% of all practitioners, but recent data suggest magnesium given this way may~     be harmful for the baby's future development. Other drugs such as antiprostaglandin agents~     are very effective in stopping uterine activity, but particularly when used for >48 hours~     have been associated with both maternal and fetal sides effects. Lastly, calcium channel~     antagonists are effective in stopping contractions and have very little in the way of~     maternal and fetal side effects, but less data is available in the United States on their~     use. Because there is no FDA approved drug to stop preterm labor, we purpose to randomize all~     women with preterm labor (20-34 weeks) to receive one of the above three methods of stopping~     preterm labor. The primary outcomes will be to see which agent stops the uterine contractions~     most effectively, for the longest period of time with fewest relapses and results in~     significant prolongation of pregnancy. If one of these agents is clearly superior to the~     other two it would help women avoid early delivery or have significant extension of their~     pregnancy to avoid some of the complications of preterm birth in the baby.~   "
210083|NCT00811044|"~     -  This study is in the area of Type 2 diabetes and genetics~        -  Healthy Volunteers and those with mild type 2 diabetes may be eligible to participate~        -  This study is searching for genes that may affect the body's processing/digestion of~          glucose/sugar~   "
210084|NCT00811031|"~     Objectives:~      Primary:~        -  To evaluate the association of the probability of increase in phosphorylation of~          platelet-derived growth factor receptor (PDGFR) of > 0.5 in peripheral blood leucocytes~          following pre-operative docetaxel chemotherapy, with progression-free survival in~          localized castration-resistant prostate cancer (CRPC)~      Secondary:~        -  To evaluate the association of the probability of increase in phosphorylated~          platelet-derived growth factor receptor (PDGFR) expression in peripheral blood~          leucocytes > 0.5 with indices of tumor regression including PSA-decline by 50% and~          measures of objective regression of tumor by transrectal MRI following pre-operative~          docetaxel therapy.~        -  Explore associations of probability of increase in phosphorylated PDGFR in peripheral~          blood leucocytes following pre-operative docetaxel therapy with plasma PDGF kinetics and~          spatial and quantitative PDGF and phosphorylated PDGFR expression in tumor and stromal~          compartments in resected specimens.~        -  Evaluate the association of probability of increase in phosphorylated PDGFR expression~          in peripheral blood leucocytes following pre-operative docetaxel chemotherapy with~          overall survival outcomes.~        -  Assess global quality of life measures at baseline and 6 and 12 months post-operatively.~        -  Create a tissue archive comprising tumor and peripheral blood specimens as a suitable~          resource for future genomic and proteomic studies.~   "
210085|NCT00811018|"~     This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily~     by subjects with PAH until sitaxsentan, in a particular country or region, is commercially~     available for the treatment of PAH or the study is closed.~   "
229791|NCT00548912|"~     The hypothesis of this trial is to assess the effect of spironolactone on heart size and mass~   "
210086|NCT00811005|"~     The purpose of this prospective, randomized, controlled, single-blinded investigation is to~     study the efficacy, tolerability and safety of oral photochemotherapy (PUVA) combined with~     acitretin versus oral PUVA combined with systemic fumaric acid esters (FAE) in patients with~     pustular palmoplantar psoriasis.~      Patients will be randomized and allocated in concealed manner to one of the two treatment~     arms: acitretin-PUVA or FAE-PUVA.~   "
210087|NCT00810992|"~     Coronary artery disease has a high death toll in the Western world. Changes in lifestyle,~     particularly in nutrition and physical activity may significantly reduce a severe coronary~     atherosclerosis within one year without the use of medication. Several dietary studies have~     shown that not only the progress of coronary artery disease can be slowed down, but it may~     also increase significantly the survival of these patients.~      Up until now there is little known about therapeutic effects by complementary medicine. In~     particular, Traditional Tibetan medicine dietary programs have shown in few case reports that~     weight could be reduced in patients with obesity.~      Therefore, the investigators developed a specific dietary program for patients with coronary~     artery disease, who have an increased cardiovascular risk profile according to the criteria~     by the International Diabetes Federation (IDF).~   "
210088|NCT00810979|"~     The purpose of this study is to determine whether SLx-4090 in combination with statin therapy~     will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.~   "
210089|NCT00810953|"~     The purpose of this study is to investigate the safety and possible efficacy of the use of~     pentamidine in the treatment of pancreatic cancer metastasis in subjects receiving standard~     therapy.~   "
210090|NCT00810940|"~     This is a randomized, controlled clinical trial at three sites to determine the safety and~     preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is~     hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient~     may have improved neurological function following treatment.~   "
210091|NCT00810927|"~     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in~     perfusion pressure. For a long time it had been assumed that the choroid is a strictly~     passive vascular bed, which shows no autoregulation. However, recently several groups have~     identified some autoregulatory capacity of the human choroid. In the brain and the retina the~     mechanism behind autoregulation is most likely linked to changes in transmural pressure. In~     this model arterioles change their vascular tone depending on the pressure inside the vessel~     and outside the vessel. In the choroid, several observations argue against a direct~     involvement of arterioles. However, the mechanism behind choroidal autoregulation remains~     unclear.~      In the present study autoregulation of the choroid will be investigated during a decrease in~     ocular perfusion pressure, which will be achieved by an increase in intraocular pressure.~     Pressure/flow relationships will be investigated in the absence or presence of a NO synthase~     inhibitor. As a control substance the alpha-receptor agonist phenylephrine will be used.~   "
210092|NCT00810914|"~     The investigators intend to perform a large randomized trial using standardized obstetrical~     and anesthetic practice at a single institution to determine the effects of patient~     controlled epidural analgesia on obstetrical and neonatal outcomes.~   "
210093|NCT00810901|"~     This study will test the effectiveness of a multimedia campaign to educate ethnic minority~     teens about the choice to become a designated organ donor on their first driver's license.~   "
210094|NCT00810888|"~     The purpose of this study is to determine if computed tomography angiography can predict~     which individuals with intracerebral hemorrhage will experience significant growth in the~     size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study~     will compare the drug recombinant activated factor VII (rFVIIa) to placebo to determine the~     effect of rFVIIa on intracerebral hemorrhage growth.~   "
210095|NCT00810875|"~     The purpose of this study is to determine if hepatitis C virus and influenza virus vaccine~     components can cross the placenta and stimulate an immune response in the fetus.~   "
210096|NCT00810862|"~     Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American~     children.~   "
210097|NCT00810849|"~     Human immunodeficiency virus (HIV) infection puts people at risk of opportunistic infections,~     such as tuberculosis. In Africa, the HIV epidemic has resulted in an increase in the number~     of cases of tuberculosis affecting various parts of the body, including the membrane~     surrounding the heart (i.e., pericardium). Pericardial tuberculosis is a serious form of~     tuberculosis that results in the death or disability of 1 in 2 affected people despite the~     use of antituberculosis medication. It has been suggested that the addition of~     corticosteroids to the antituberculosis medication could result in the reduction of the~     number of deaths caused by the disease, but this proposal remains to be confirmed in~     appropriately designed clinical trials. Similarly, vaccination with the Mycobacterium w~     injection is also proposed as a possible way of reducing the damage caused by the~     tuberculosis infection of the heart. The investigators are proposing to conduct a clinical~     trial in which people who are on antituberculosis treatment for pericardial tuberculosis will~     be randomly allocated to receive either prednisolone or a matching placebo tablet, or~     Mycobacterium w injection or placebo injection. The number of people who die or who develop~     hardening of the pericardium with compression of the heart (called pericardial constriction)~     or who need emergency evacuation of the pericardial fluid from pericardial sac for severe~     compression (called tamponade) will be compared in each group to determine whether the use of~     corticosteroids or Mycobacterium w injection is safe and results in reduction in the death~     rate. If corticosteroids and Mycobacterium w are shown to safely reduce the death rate, then~     they will be recommended for use in all patients with tuberculosis of the pericardium in the~     future.~   "
210098|NCT00810836|"~     The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms~     of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who~     still suffer symptoms of RA. The purpose is also to ensure that the combination of~     methotrexate is safe for patients to take and that any side effects are acceptable to~     patients with RA.~   "
210279|NCT00808405|"~     To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV)~     shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a~     history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to~     receive episodic acyclovir 400mg orally three times daily or matching placebo three times~     daily for 5 days and who are followed for a total of 13 days.~   "
210099|NCT00810823|"~     Gastric bypass surgery has in many studies shown total remission of type 2 diabetes as early~     as 1 - 2 days after surgery and this is before any real weight loss has occurred. This~     suggest that the remission of the diabetes is due to the direct effect of the operation more~     that the secondary effect of the weight loss. The reason for the major effect on the glucose~     metabolism after gastric bypass surgery is still unaccounted for.~      This PhD. project will try to unveil some of the mechanisms that could explain the effect of~     gastric bypass surgery on the glucose metabolism seen in patients with type 2 diabetes.~      The hypothesis of the study is that a factor X will course the remission of the diabetes.~     This factor X is related to the anatomic changes of the gastro intestinal tract, by~     eliminating the foods passage through the distal part of the ventricle and the duodenum, in~     combination with the Roux- en-Y sling.~      The PhD. project will consist of clinical trails on patients that will undergo gastric bypass~     surgery. The studies will take place before and within the 1. week after surgery. The~     investigators will measure different hormones and adipokines in fast and the postprandial~     state. To discover possible new proteins the investigators will run proteomic on some~     samples. All the results will be compared to the same parameter on patients undergoing~     gastric banding, where the anatomy of the intestine hasn't been changed.~   "
210100|NCT00810810|"~     This study is designed to provide information on patients' immune response after exposure to~     transfused blood.~      Blood transfusions may have opposite immune effects on patients. One is sensitization. The~     other is immunosuppression. The magnitude of these effects in patients who are not on~     chemotherapy is unknown.~      These effects are thought to be due largely to white blood cells present in the transfusion~     product. Leukofiltration and gamma-irradiation are the special treatments that deplete~     white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of~     donor blood is thought to deplete the white blood cells most effectively.~      In this study, patients scheduled for cardiac surgery are randomly assigned to receive blood~     products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If~     their physician orders transfusions, they will receive products assigned to their group.~     Patients are asked to provide two blood samples during the 4 weeks after surgery.~      Studies will measure changes in antibody to HLA and in cells that regulate the immune~     response. The levels of sensitization and immunosuppression will be correlated to the~     transfusion products received.~   "
210101|NCT00810797|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     exemestane may fight breast cancer by lowering the amount of estrogen the body makes.~      PURPOSE: This phase II trial is studying how well exemestane works in treating postmenopausal~     women with stage IV breast cancer.~   "
210102|NCT00810784|"~     VTE prophylaxis is not as routinely employed in medically ill patients as compared to~     surgical patients. This retrospective chart review project will evaluate the effectiveness of~     VTE prophylaxis in medically ill patients at the University of Utah Hospitals and Clinics~     compared to current literature. The study will ultimately serve as a quality improvement~     project to help improve patient care.~   "
210103|NCT00810771|"~     The goal of this study is to evaluate whether an educational tool about colorectal cancer~     (CRC) completed on a computer that helps patients clarify their CRC screening preferences~     will lead to increased screening rates for CRC compared to standard information delivered via~     computer.~   "
210104|NCT00810758|"~     To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral~     doses of PF-04878691.~   "
210105|NCT00810745|"~     This randomized study was designed to compare the 2 year clinical and functional results with~     the STARR procedure using a new curved cutter stapler or the same operation done with 2~     traditional circular staplers.~   "
210106|NCT00810732|"~     This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney~     disease.~   "
210107|NCT00810719|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving gemcitabine together with erlotinib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib~     works in treating patients with metastatic or recurrent pancreatic cancer.~   "
210108|NCT00810706|"~     The ATENA phase III randomized parallel-group multicenter trial is designed to compare 5~     years of adjuvant exemestane versus 5 years of observation in postmenopausal women with~     operable breast cancer who have received 5-7 years of adjuvant tamoxifen. The primary~     endpoint for the core protocol is disease-free survival (DFS). Exemestane treatment is~     planned for 5 years unless disease relapse or excessive toxicity is documented, the patient~     refuses further treatment or any new anti-cancer therapy is initiated.~   "
210109|NCT00810693|"~     The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521~     given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension~     (PAH).~   "
210110|NCT00810680|"~     The purpose of this study is to determine whether Valproic acid, as a single agent is~     effective in the treatment of Chronic Lymphocytic Leukemia which has relapsed or is~     refractory to therapy with standard drugs.~   "
210111|NCT00810667|"~     The objective of this study is to explore the efficacy, safety and cognitive properties of Lu~     AE58054 as augmentation therapy to risperidone in patients with schizophrenia.~   "
210112|NCT00810654|"~     Oral supplementation with enzymes that can cut gluten has been suggested as a potential~     treatment modality for coeliac disease. In the present study the investigators wish to~     determine if co-administration of such an enzyme, a prolyl endoprotease derived from the food~     grade organism Aspergillis niger (AN-PEP), is capable of detoxifying 8 grams of gluten in a~     commercial food product.~   "
210113|NCT00810641|"~     The purpose of this study was to compare the immediate efficacies of each treatment maneuvers~     in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).~   "
210280|NCT00808392|"~     This study will investigate safety and immunogenicity of a monovalent conjugated vaccine~     against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.~   "
210355|NCT00807391|"~     The aim of this study is prospectively to determine the diagnostic sensitivity of~     Transbronchial Catheter Aspiration (TBCA) in comparison with Transbronchial Needle Aspiration~     (TBNA) in the diagnosis of peripheral nodules and masses of the lung.~   "
210114|NCT00810628|"~     The purpose of this pilot program is to develop and evaluate a new treatment program for~     depression in Parkinson's disease (PD). The treatment uses Cognitive Behavior Therapy(CBT)to~     teach patients how to become more aware of their thoughts and feelings and to change thinking~     patterns and behaviors that may be related to depressive symptoms. This is the first time~     that this treatment has been used in a group setting for depression in PD.~      Target population is patients in the Movement Disorders Clinic at Oregon Health & Science~     University who have Parkinson's disease and mild to moderate depression.~   "
210115|NCT00810615|"~     The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the~     cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain~     injury (TBI). Cognitive function includes such things as thinking, remembering, recognition,~     concentration ability and perception. Traumatic brain injury is common with head injuries~     caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to~     an intervention or sham arm. Computer based cognitive tests will be used as outcome measures.~     Subjects are enrolled by invitation only.~   "
210116|NCT00810602|"~     The proposed research study is to test the drug vorinostat, in a new use as an additional~     medication, with other standard treatments for the prevention of severe acute graft versus~     host disease (GVHD).~      If this treatment is safe and effective, when combined with a reduced intensity transplant,~     the research may achieve a more effective therapy for patients with high-risk, blood cell~     related cancers.~      All subjects will receive an identical, known treatment to test if the treatment is safe and~     effective (a phase II trial). For patients to take part they must have a high-risk, blood~     cell cancer, be suitable candidates to receive a reduced intensity transplant and have a~     matched, related donor.~      Adult subjects (age 18 years and older) will be considered as subjects provided, as detailed~     in the protocol, they meet additional criteria and are not excluded from participating. About~     fifty (50) subjects will be enrolled in this study at the University of Michigan.~      Patients who receive blood stem cell transplants (HSCT), also called bone marrow transplants,~     to treat their cancer are at risk for serious complications, which may sometimes be fatal.~     The more common, serious ones are relapse (return of their disease), body organ injury from~     the intensity of the chemotherapy given prior to their transplant, and a serious complication~     called graft versus host disease (GVHD). GVHD is a form of rejection, where the transplanted~     cells of the donor attack the recipient's body as foreign, and do damage to organs and~     tissues.~      To decrease the side effects of the chemotherapy given before a transplant, reduced intensity~     treatment plans(regimens)have recently been developed at a number of transplant centers. A~     decrease in the side effects of chemotherapy (called toxicities) has been achieved; however,~     this success with less intensive treatments has been partially offset by less successful~     results in controlling the patient's cancer.~      As mentioned above, GVHD is a form of transplant rejection. GVHD can affect the digestive~     system, skin, liver and other body systems. GVHD can increase the risk of infection. After a~     matched, related donor stem cell transplant, GVHD when severe, is a major cause of~     discomfort, organ damage, and even death. When a graft vs host reaction develops, but is kept~     under control, studies show there may be a beneficial graft versus tumor effect, helping to~     destroy tumor cells in the patient, and thus providing a more effective control of their~     cancer.~      The goal of this study is to try to maximize the potential benefits, of giving patients less~     intense chemotherapy to reduce the toxic effects, letting the graft vs host effect help in~     destroying tumor cells, but preventing acute severe GVHD by using the drug vorinostat,~     combined with standard medicines, to reduce the chance of serious GVHD-related complications.~   "
210117|NCT00810589|"~     Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes~     have shown a prolonged and reproducible action profile of insulin detemir compared with NPH~     insulin and insulin glargine. Duration of action of insulin detemir has been reported to be~     up to 24 hours.9,10,11 It has, however, been proposed that the mean duration of action is~     underestimated in glucose clamps lasting only 24 hours. This is so because a duration of~     action longer than 24 hours in individual clamps will be set to 24 hours in the mean~     calculation, whereas a shorter duration of action in individual clamps will be set to the~     true value.~      It has been shown in clinical pharmacology trials that NPL insulin has an action profile~     comparable to NPH insulin in subjects with type 1 diabetes. , However, a direct comparison of~     pharmacodynamic properties of insulin detemir and NPL insulin has not been performed to date.~      To get further insight into the pharmacodynamic properties of insulin detemir compared with~     NPL insulin, this trial has been designed to compare pharmacodynamics in general and duration~     of action in particular between insulin detemir and NPL insulin in subjects with type 1~     diabetes.~   "
210118|NCT00810576|"~     Primary Objectives:~        1. To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma~          (NHL)receiving the combination of vorinostat and bortezomib~        2. To evaluate the safety and tolerability of the combination of vorinostat and bortezomib~          in patients with relapsed or refractory T-cell NHL.~      Secondary Objectives:~        1. To assess overall survival and time to treatment failure in patients with T-cell NHL~          treated with the combination of vorinostat and bortezomib.~        2. Correlative studies will be done to assess the role of vorinostat mediated apoptosis~          along with bortezomib synergy. Changes in marker expression from baseline to post~          treatment will be correlated with patient clinical response.~   "
210119|NCT00810563|"~     The use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some~     surgeries. In the ase of tubal ligation by electrocoagulation, where pain is reduced, there~     is no evidence of this benefit. The objective of this study is to verify the degree of pain~     after laparoscopic tubal ligation surgery in patient who received bupivacaine 0.5% in the~     portal, or placebo~   "
210120|NCT00810550|"~     Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most~     common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The~     standard test to find coronary artery disease is coronary angiography. This test is highly~     accurate but is invasive and carries a small risk of complications. This study investigates~     ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery~     disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid~     ultrasound will have excellent negative predictive value for severe CAD.~   "
210121|NCT00810524|"~     Influence of antiviral treatment to the long term prognosis of patients with chronic HBV~     infection. The aim of antiviral treatment for HBV is to reduce the long term severe~     complications. In this study, the investigators divided patients with chronic HBV infection~     into two groups, which start early antiviral treatment and conventional antiviral treatment~     respectively. All the patients will be followed for ten years. From this study, the~     investigators want to find out the optimal time for patients with chronic HBV infection to~     start antiviral treatment.~   "
210122|NCT00810511|"~     The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.~   "
210123|NCT00810485|"~     The purpose of this study is to evaluate the effect of ADX10059 in patients with~     gastroesophageal reflux disease who are partial responders to proton pump inhibitors~   "
210298|NCT00808158|"~     Metabolic syndrome is a term that describes a group of conditions that increase the risk of~     cardiovascular disease. The conditions include high blood pressure, obesity, and high~     cholesterol. This study will examine how changes in tobacco exposure and weight can affect~     the risk of developing metabolic syndrome among adolescents.~   "
210124|NCT00810472|"~     Penetrating keratoplasty is one of the most commonly performed transplantation surgeries.~     Graft rejection is a major complication. HLA compatibility has already been demonstrated an~     effective prophylaxis in several retrospective investigations. The purpose of the~     investigators randomized clinical trial is to demonstrate superiority of HLA matching in~     comparison to random graft assignment with respect to the endpoint 'time to first endothelial~     graft rejection' in penetrating keratoplasty. The investigators will perform DNA-based allele~     resolution typing.~   "
210125|NCT00810446|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
210126|NCT00810433|"~     The purpose of this study is to collect data regarding the safety and feasibility of the~     GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional~     approaches for interbody lumbar fusion. This is in order to allow for evidence-based~     comparison to pedicle-screw-based techniques as described in the literature.~   "
210127|NCT00810420|"~     The aim of this study is based on recent pilot studies carried out at Odense University~     Hospital showing that the acute changes in electroencephalographic (EEG) signals (i.e.~     electrical activity inthe brain) elicited by insulin-induced hypoglycemia in patients with~     type 1 diabetes can be reliable detected by real-time processing of these EEG signals using~     mathematical algorithms and state of the art noise and artifact reduction. These preliminary~     results also showed that the hypoglycemia-induced EEG changes are detectable 15-30 min before~     deterioration in cognitive function impedes an adequate response to warning. We hypothesize~     that these observations apply to the majority of patients with type 1 diabetes, and~     therefore, that it is possible to develop an automated device to detect hypoglycemic episodes~     by continuous real-time monitoring and processing of EEG signals. To test our hypothesis, the~     specific aims of the present proposal are:~        1. Detection of hypoglycemia-induced EEG changes using subcutaneous electrodes~        2. Ambulatory EEG monitoring using subcutaneous electrodes~   "
210128|NCT00810407|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
210129|NCT00810394|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to~     see how well it works in treating patients with advanced malignant solid tumors.~   "
210130|NCT00810381|"~     Glaucoma, one of the most common causes of blindness, is associated with increased~     intraocular pressure (IOP) and optic nerve head ischemia. Nitrovasodilators are discussed in~     the treatment of glaucoma. Nitrates relax smooth muscle cells in the vasculature by~     liberating the vasodilator nitric oxide.~      The IOP lowering potential and the vasodilator action in retinal and choroidal vessels of~     nitrates is still a matter of controversy. Previous studies on the ocular hemodynamic effects~     of nitrates showed partially contradicting results. In addition the IOP lowering effect of~     nitrates is still unclear. However, recent studies show that long acting nitrates may~     preserve optic nerve deterioration and visual field loss.~      Therefore, the role of nitrovasodilators in control of ocular blood flow and intraocular~     pressure has to be elucidated. For this purpose the investigators plan to test the hypothesis~     that nitrovasodilators improve ocular blood supply to the optic nerve head at doses which do~     not affect systemic hemodynamics.~   "
210131|NCT00810368|"~     The purpose of this study is to perform a randomized double-blind, placebo-controlled, 12~     week study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle~     strength outcomes in 100 GWI subjects.~   "
210132|NCT00810355|"~     This research studies the effects of Cognitive Behavior Therapy and Cognitive Remediation on~     work for persons with schizophrenia. Cognitive Behavior Therapy is a form of counseling that~     helps people to improve their mental health by changing the way they think about themselves~     and others. Cognitive Remediation is an exercise to improve the thinking process. The purpose~     of this study is to determine the extent to which Cognitive Remediation combined with~     Cognitive Behavior Therapy helps people who are working.~   "
210133|NCT00810342|"~     This is a study testing ways to motivate new mothers to become more physically active over a~     one year period.~   "
210134|NCT00810329|"~     The purpose of this study is:~        1. To identify specific set of proteins in the cerebrospinal fluid (fluid surrounding the~          brain and the spinal cord), that are believed to be seen in Chronic fatigue syndrome~          (CFS) patients, but not in healthy controls (HC). A similar study that the investigators~          had conducted before,suggested that significant changes in proteins in the cerebrospinal~          fluid may be due to the fundamental pathology of this disorder.~        2. Increased cerebrospinal fluid pressure (pressure that helps the cerebrospinal fluid to~          move around the brain and the spinal cord), may be related with certain symptoms like~          headache, sleep problems, light headedness, increased pain, excessive tiredness~          (fatigue) even with minimal work and memory problems.~        3. Assessment of Autonomic Nervous system function (Sympathetic nervous system)between the~          CFS and HC.~        4. Perform Lung Function Testing or pulmonary function test to estimate the lung capacities~          and score shortness of breath while performing breathing maneuvers.~        5. Dolorimetry (18 tender point test) for assessment of pain threshold.~        6. Capsaicin skin test~        7. Allergy skin test~   "
210135|NCT00810316|"~     To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy~     volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release,~     and clonazepam tablet.~   "
210136|NCT00810303|"~     The purpose of this study is to evaluate the effects of a chronic co-medication of efavirenz~     on pharmacokinetics and sterol-lowering effects of ezetimibe at steady-state in healthy~     subjects genotyped for ABCB1, ABCC2, CYP2B6 and UGT1A1.~   "
210330|NCT00807742|"~     The aim of this study is to determine whether contingent reinforcement for smoking~     abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief~     counseling and nicotine replacement on smoking abstinence of substance abusers in residential~     treatment.~   "
210137|NCT00810290|"~     The Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational~     research study which aims to reduce the risk of diabetes among Latinos who have a >30%~     probability of developing diabetes in the next 7.5 years per a predictive equation. The~     project was conducted in Lawrence, Massachusetts; a predominantly Caribbean-origin urban~     Latino community. Individuals were identified primarily from a community health center's~     patient panel, screened for study eligibility, randomized to either a usual care or a~     lifestyle intervention condition, and followed for one year.~   "
210138|NCT00810277|"~     This single arm study will assess the safety and efficacy of tocilizumab in patients with~     moderate to severe active rheumatoid arthritis who have an inadequate response to current~     non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks~     for a total of 6 infusions, either as monotherapy or in combination with their current~     non-biologic DMARDs.~   "
210139|NCT00810264|"~     The objective of this study is to confirm the long-term safety and reliability of the Corox~     OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a~     registry documenting the post approval clinical experience of these leads be designed and~     implemented.~   "
210140|NCT00810251|"~     The purpose of this observational study is to document the treatment of serial rib fractures~     with MatrixRIB implants in a registry.~   "
210141|NCT00810238|"~     The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of~     left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells~     (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.~   "
210142|NCT00810225|"~     Determine if:~        -  genetic differences of CNDP1 gene~        -  the previously defined GWI/Chronic Fatigue Syndrome (GWI/CFS) cerebrospinal fluid~          proteome contents~        -  psychometric~        -  other variables can differentiate between veterans of the 1990-1991 Persian Gulf War who~          have autonomic, neurological and other symptoms and those without these complaints.~   "
210143|NCT00810212|"~     The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in~     subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral~     levels between L1 and S1 and undergoing posterolateral lumbar fusion.~   "
210144|NCT00810199|"~     This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with~     methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients~     receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg~     intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv~     every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment~     adjustments (increase or decrease of treatment intensity) may be introduced at intervals,~     based on response. The anticipated time on study treatment is up to 3 years, and the target~     sample size is approximately 470 patients.~   "
210145|NCT00810186|"~     Background: Patients that suffer from respiratory failure and need mechanical ventilation are~     at risk of further deterioration due to complications induced by progression of lung disease~     or the mechanical ventilation. The complications usually develop in a progressive manner, but~     are currently detected relatively late, when there is already severe and life threatening~     deterioration in patient oxygenation and sometimes irreversible damages.~      Objective:To measure chest wall dynamics, derived from sensors placed on the chest and~     abdomen.~      Methods: The system comprises of patches attached to the chest wall and upper abdomen that~     include mechanical sensors that measure the mechanics of lung inflation and deflation.~   "
210146|NCT00810173|"~     To assay the influence of personality profile to promote behavior change adherence for~     physical activity using a pedometer. The investigators also studied the metabolic profile,~     diagnosis of depression, intention to change behavior, physical activity referred and the~     quality of life. Casuistic and Methods: a randomized quasi-experimental enrolling 48 T2DM~     patients using a pedometer for 6 weeks. The intervention group received phone calls~     stimulating them to increase their walking activity. The control group received only one~     telephone call to explain pedometer use. The investigators also analyzed the personality~     profile, quality of life, and metabolic and anthropometric indexes.~   "
210147|NCT00810160|"~     The purpose of this study is to see whether dietary supplements can change the germs in the~     intestines of premature infants to be more like those of healthy breast fed term babies.~   "
210148|NCT00810147|"~     The purpose of this study is to determine the safety and tolerability of BMS-708163 in~     patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and~     the course of any potential effects during a 12-week wash-out period~   "
210149|NCT00810134|"~     The aim of the study is to compare PTFE-graft bypass surgery versus Viabahn endoprosthesis~     for femoropopliteal arterial occlusion in intermittent claudication and critical ischaemia in~     patients who would be technically amenable for both treatments. The primary objective is to~     compare primary patencies of the two treatments. The secondary objective of the study is to~     evaluate secondary patency, functional status, the quality of life and costs of the new~     endovascular therapy.~   "
210150|NCT00810121|"~     Primary objective:~      To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x~     2 day in patients presenting with pain related to closed, benign, acute post-traumatic~     conditions of the motor system or acute, non-infectious rheumatologic conditions, by~     comparing, on the one hand, changes in resting pain intensity over the entire day, measured~     at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total~     intake over 5 days of concomitant analgesics.~      Secondary Objectives:~        -  To describe concomitant analgesic treatments~        -  To describe the time between baseline and use of a step I, II or III analgesic~        -  To evaluate patients pain relief using a Likert 4-class scale (complete or substantial~          relief, moderate relief slight relief and absence of relief) at D5~        -  To evaluate changes in intensity of pain when moving, over the entire day, measured at~          the end of the day using a numeric scale, over 5 days~        -  To evaluate the patients overall satisfaction at the end of treatment using a 4-point~          Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied,~          very unsatisfied)~        -  To evaluate the patients overall satisfaction at the end of the study using a 4-point~          Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied,~          very unsatisfied)~        -  To compare the safety of the two treatments~   "
210151|NCT00810108|"~     The objective of this study is to compare the pharmacokinetics of lopinavir tablets~     administered to pediatric patients as either whole or crushed tablets. The study is a~     randomized,open-label, crossover study of pediatric subjects already taking~     lopinavir/ritonavir tablets as part of their clinical care. THe investigators hypothesize~     that lopinavir exposure in pediatric patients will be lower after taking a dose of the tablet~     formulation, crushed and mixed with pudding or yogurt, as compared to the exposure after~     taking a dose with tablets swallowed whole.~   "
210152|NCT00810095|"~     The primary study objective is to assess the feasibility of using the MindFrame System to~     safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients~     experiencing an ischemic stroke.~   "
210153|NCT00810082|"~     The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number~     and severity of falls in older adults. This is a pilot study. The information collected will~     be used to support a grant application for a large multi-center trial in the future.~   "
210154|NCT00810069|"~     This study investigates two different approaches to the change in antidepressant treatment~     when an initial treatment is not effective: early intervention or delayed intervention.~      Two hypothesis will be tested:~        1. that time to confirmed response is shorter in the early intervention strategy vs.~          delayed intervention strategy~        2. that the time to confirmed remission is shorter in the early intervention strategy~          compared to delayed intervention strategy.~   "
210155|NCT00810056|"~     This is a multi-county randomized controlled trial of the Fostering Healthy Futures (FHF)~     preventive intervention program (consisting of mentoring and skills groups) with 256~     maltreated preadolescent youth in out-of-home care. It is hypothesized that participation in~     the FHF program will result in better functioning in cognitive, social, and behavioral~     domains, and that these gains will result in improved mental health functioning, quality of~     life, and reductions in problem behaviors and adverse life-course outcomes.~   "
210156|NCT00810043|"~     The objective of this study is to measure the effect that the scraping and scoring of~     vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height~     restoration and angular deformity correction during a balloon kyphoplasty procedure.~   "
210157|NCT00810030|"~     The purpose of this study is to determine how safe, tolerable and effective the new~     standardised dosage regimen of FERINJECT® infusions is, compared with a well established~     intravenous iron treatment.~   "
210158|NCT00810017|"~     This study is for women and men who have previously treated metastatic (has spread to other~     parts in the body), Her2- positive breast cancer. The purpose of this study is to find out~     what effects (good and bad) the FDA-approved drugs etoposide and trastuzumab have on this~     type of breast cancer and to determine if these drugs are safe to use together. This research~     is being done to find more effective treatment for this type of condition.~      In this study, trastuzumab and etoposide will be given by intravenous infusion (IV; through a~     vein) on the first 3 days of every 3-week cycle. This is repeated for 6 cycles. After 6~     cycles, only trastuzumab will be given until worsening of disease. In this study, a small~     amount of your tissue that was collected when you had surgery will be evaluated in the lab to~     look at genetic differences among people and how those differences may affect a response to a~     specific drug or medicine. This testing will look for a gene called Top2A. Previous studies~     suggest that people who have both the Top2A and Her2 genes respond to certain chemotherapies~     (anti-cancer drugs) differently from those who only have the Her2 gene.~   "
210159|NCT00810004|"~     The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.~   "
210160|NCT00809991|"~     This will be a Phase II study evaluating the effectiveness and toxicity of a specific~     radiation therapy regimen. This choice of daily dose is based on the prior published~     experience showing safety and efficacy of hypofractionated regimens. The total dose is~     calculated to be effective for late effects which has been shown to be effective and safe in~     a large prospective Phase II study. If the hypothesis for the prostate is is true, then this~     regimen should be at least as effective or more effective for tumor control than the current~     conventional therapy.~   "
210161|NCT00809965|"~     The purpose of this study is to determine whether rivaroxaban in addition to standard care~     reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke~     in patients with a recent acute coronary syndrome compared with placebo.~   "
210162|NCT00809952|"~     The purpose of this study is to ascertain whether using ultrasound guidance during~     intrauterine insemination (IUI) could increase pregnancy rates.~   "
210163|NCT00809939|"~     Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous~     studies showed that administration of progesterone to pregnant women at high risk, decrease~     spontaneous preterm deliveries.~      The purpose of this study is to compare between two different modes of treatment with~     progesterone for the prevention of preterm delivery: weekly injection of 17 alfa~     hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of~     efficacy, comfort and compliance, safety and cost of treatments.~   "
210164|NCT00809926|"~     To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to~     valsartan alone in patients with Stage 2 hypertension.~   "
210165|NCT00809913|"~     The purpose of this study is to determine whether a 7-day duration of antibiotic treatment of~     febrile urinary tract infection (FUTI) is non inferior to 14-day standard duration of~     treatment in unselected population presenting at primary care or emergency department.~   "
210166|NCT00809900|"~     This study hypothesis is that anthocyanins from cranberry juice are bioavailable and can be~     measured in blood and urine after a single acute consumption of cranberry juice.~   "
210167|NCT00809887|"~     The study proposes to investigate, in children admitted at Children`s Medical Center at~     Dallas, the effectiveness of antimicrobial lock therapy (ALT) with Micafungin in combination~     with systemic antifungal therapy in catheter-related fungal infections in order to salvage~     highly needed central venous catheter (CVC) and at the same time to investigate the~     effectiveness of Micafungin alone as systemic therapy in the treatment of Candidemia in a~     pediatric population.~   "
210168|NCT00809874|"~     The purpose of this study is to determine the effects of dietary protein on blood lipids and~     gut hormones after a fat-rich meal.~      Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream~     following a fat rich meal. The effect is dependant of both the quality and the quantity of~     protein ingested.~   "
210169|NCT00809861|"~     Aim: Osteosynthesis with locking plate/screws has become increasingly popular in recent~     years. It is the only treatment option which allows immediate postoperative immobilization.~     However, compared to conservative treatment or treatment with external fixators, locking~     plates are very expensive and the operation can be very challenging, even for experienced~     surgeons. The long-term results of all treatment modalities are equal, which has been shown~     in numerous studies. However, there are no evidence based studies published yet which look at~     short-term outcomes. The investigators do feel but do not know that patients who do not need~     postoperative immobilization return to work significantly earlier or are independent faster~     than patients whose wrists are immobilized for up to 6 weeks. If that is the case, then the~     higher costs and risks of the operation are justified, if not, then we have to re-evaluate~     our indications for using locking distal radius plates distal radius Methods: Group 1:~     Treatment of distal radius fractures with either volar or dorsal locking plates. No fixation~     postoperatively, immediate ROM (range of motion) exercises and usage of the wrist in~     activities of daily life (ADL) allowed.~      Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints~     are time to return to work / return to independency (in older people), ROM; Grip strength~     (with Jamar Dynamometer).~      Outcome scores are DASH (Disability of Arm, Shoulder and Hand Score)and PRWE (Patient related~     wrist evaluation).~      Group 2 Treatment of distal radius fractures with either an external fixator +/- K-wires or~     with K-wires and forearm cast or by cast alone. Main issue is that the wrist is immobilized~     for a period of 6 weeks. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks~     postoperatively. Endpoints are time to return to work / return to independency (in older~     people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH and PRWE. Both~     plating and external fixation / cast fixation are standard and accepted treatment modalities~     for distal radius fractures. A power analysis indicated that a total sample size of 52~     patients randomized equally (1:1) to each treatment arm without any blocking or~     stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20%~     difference in mean DASH and PRWE scores.~   "
210170|NCT00809848|"~     The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in~     comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each~     morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will~     be followed for 2 weeks.~   "
210171|NCT00809835|"~     We are testing to see if Galantamine, a learning enhancing medication, will help methadone~     maintained cocaine abusers with their learning and memory specific to CBT using an innovative~     CBT computer program.~   "
210172|NCT00809822|"~     Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national~     diagnostic criteria. Patients who meet all inclusion criteria and conflict the exclusion~     criteria will receive NPB-01(intravenous immunoglobulin) 400mg/kg/day for five consecutive~     days or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for therapy of~     bullous pemphigoid will evaluate using pemphigoid activity score involving skin lesion area~     and Number of new blisters.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by 57 days after the start of the study treatment.~   "
210173|NCT00809809|"~     Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.~   "
210174|NCT00809796|"~     The purpose of this study is to investigate the safety and possible efficacy of the use of~     pentamidine in the treatment of colon cancer metastasis in subjects receiving standard~     therapy.~   "
210175|NCT00809783|"~     Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab~   "
210176|NCT00809770|"~     The purpose of this study is to determine the effectiveness of a behavioral treatment,~     contingency management, in reducing stimulant use in persons with serious mental illness.~   "
210177|NCT00809757|"~     A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI~     and Placebo in Subjects Aged Birth to <48 Months with Asthma.~   "
210178|NCT00809744|"~     In this study the investigators want to compare glucose handling (insulin secretion and~     insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of~     vitamin D, using a hyperglycemic clamp technique, were sugar is given intravenously for 3~     hours in order to keep the blood sugar level at 10 mmol/L. Those with low vitamin D levels~     will be randomized to treatment with vitamin D3 (cholecalciferol) 40 000 IU/week or placebo~     for 6 months before a new clamp is performed.~      The study hypothesis is that persons with low vitamin D levels have impaired glucose handling~     which might be improved by vitamin D supplementation.~   "
210179|NCT00809731|"~     The objective of this study is to evaluate under routine clinical setting the efficacy and~     remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute~     episode or not achieving remission under regular treatment from schizophrenia/schizoaffective~     disorder. This study will collect in real-life practice the severity of schizophrenia by~     Clinical Global Impression (CGI), also evaluate the criteria of schizophrenia remission~     applying 8 items of Positive and Negative Syndrome Scale (PANSS) from Andresen working group,~     the Montgomery and Asberg Depression Rating Scale (MADRS), and the Global Assessment of~     Functioning Scale (GAF). Side effect of movement disorder will be evaluated by Drug Induced~     Extrapyramidal Symptoms Scale (DIEPSS). Tolerability for treatment will be monitored by~     documenting spontaneous reports on adverse events as well as change in body weight.~   "
210180|NCT00809718|"~     The aim of this study is to study the effect of rifapentine on plasma concentrations of~     raltegravir.~   "
210181|NCT00809705|"~     This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric~     emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups~     to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4~     weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12~     weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a~     paracetamol test at intervals during the study. The anticipated time on study treatment is 3~     months, and the target sample size is <100 individuals.~   "
210182|NCT00809692|"~     A critical first step to address the pharmacodynamic information gap in pediatrics resides~     with the development of methods capable of accurately measuring the time dependent effects of~     xenobiotic exposure in a manner sufficient to enable an integrative analysis of drug action~     which incorporates both pharmacokinetic and pharmacogenetic determinants. The proposed study~     will evaluate laser Doppler flowimetry, a necessary initial step in developing an ideal~     pharmacodynamic surrogate endpoint that ultimately could be used in infants, children and~     adolescents to fully characterize the impact of development on the pharmacokinetic (PK) /~     pharmacodynamic (PD) / pharmacogenetic (PG) determinants of drug effect for agents capable of~     modulating the cellular response to histamine.~   "
210183|NCT00809679|"~     The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with~     postherpetic neuralgia.~   "
210184|NCT00809666|"~     The aim of the PRAM study was to determine whether women diagnosed with hypertension in~     pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood~     pressure is measured by either an automated device or a mercury device throughout the~     pregnancy.~   "
210185|NCT00809653|"~     Air pollution is a major cause of cardiorespiratory morbidity and mortality. The exact~     components of air pollution that underlie the cardiovascular effects are not yet known, but~     combustion-derived particulate matter is suspected to be the major cause. Epidemiological~     studies have shown that exposure to air pollution causes exacerbation of existing~     cardiorespiratory conditions leading to increased hospital admissions and death. The~     investigators have recently conducted a series of controlled exposure studies to urban~     particulate matter and diesel exhaust in healthy volunteers and patients with coronary heart~     disease. The investigators found that controlled exposure to dilute diesel exhaust in~     patients with prior myocardial infarction induced asymptomatic myocardial ischaemia with an~     increase in electrocardiographic measures of myocardial ischaemia. Whilst important, further~     questions remain: (i) does air pollution exposure exacerbate ischaemia and reduce exercise~     tolerance in patients with symptomatic angina pectoris, (ii) do real world exposures as~     encountered in the urban environment of major cities have similar effects, and (iii) can a~     simple face mask intervention to reduce exposure to particulate air pollution improve health~     outcomes in patients with coronary heart disease?~   "
210186|NCT00809640|"~     The objective is to assess the effectiveness of a prevention campaign promoting active~     management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from~     a random sample of schools in Majorca, Spain: private, public and concerted. A 10 item~     questionnaire will be given to all children in that age group, to be answered in class on~     days 1, 14 and 97. Schools will be randomly assigned to the study and control groups. In the~     study group the students will get a Back Comic-Book (promotes active management) after the~     first assessment. The control group will have no other intervention than the questionnaire.~   "
210187|NCT00809627|"~     Caffeine will be studied against placebo in patients with positional headache after a lumbar~     puncture (aka spinal headache).~   "
210188|NCT00809614|"~     This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis.~     The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses~     of AIN457 10 mg/kg administered three weeks apart.~   "
210189|NCT00809601|"~     There are different kinds of ear tubes that may be inserted into the tympanic membrane to~     relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The~     tubes differ in size, shape and material.~      No-one knows if there are differences between the different kinds of tubes regarding~     complications.~      The investigators' hypothesis is that there is differences between the different kinds of~     tubes regarding complications.~      To test the investigators' hypothesis, the investigators are about to conduct a randomized~     controlled study of four kinds of tubes having two different material and two different~     shapes.~   "
210190|NCT00809588|"~     The purpose of this study is to see if the proposed therapy will delay or stop the~     progression of the participants skin cancer. This study is being done because there are~     currently no treatments which have been shown convincing to treat disease which has~     progressed. This research study is designed to evaluate the immunologic effects and clinical~     side effects of giving vaccines to patients that are made from their own skin cancer cells.~   "
210191|NCT00809575|"~     RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from~     patients with myelodysplastic syndromes may help doctors learn more about the disease and may~     help plan treatment.~      PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly~     diagnosed myelodysplastic syndromes.~   "
210192|NCT00809562|"~     This study will evaluate the safety, tolerability and efficacy of RO4917523, in comparison to~     placebo, in patients with treatment-resistant depression. Following a washout period from~     existing anti-depressant medication, cohorts of patients will be randomized to receive daily~     oral RO4917523 at up to five different doses (according to the safety and tolerability~     observed at the lower doses during the study), or placebo. The anticipated time on study~     treatment is 10 days (in an inpatient unit), and the target sample size is <100 individuals.~   "
210193|NCT00809549|"~     1. Circulating bone marrow and blood vessel precursors home in to sites of ischemia and aid~          regeneration of injured tissue~        2. Increasing the number of circulating precursors will improve in regeneration of damaged~          brain following ischemic stroke.~   "
210194|NCT00809536|"~     1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single~          dose of metformin from the body~        2. To estimate the effects of multiple doses of metformin on the elimination of a single~          dose of PD 0332334 from the body~        3. To evaluate the safety and tolerability when PD 0332334 and metformin are administered~          at the same time.~   "
210195|NCT00809523|"~     This is a randomized, controlled clinical trial of inactivated negative ion generation or~     light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression),~     for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type,~     to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase~     and a 4 week treatment phase.~   "
210196|NCT00809510|"~     The purpose of this study is to evaluate the long-term safety and tolerability of ABT-089 in~     adults with mild-to-moderate Alzheimer's disease.~   "
210197|NCT00809497|"~     The main objective of this study is to evaluate the effectiveness and safety of the~     propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the~     placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with~     oral supplementation of 2g daily for a 4 months continuous administration.~   "
210198|NCT00809484|"~     To investigate the management of bone health in postmenopausal women with early breast cancer~     (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive~     early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility~     fracture. Patients (pts) with a bone mineral density (BMD) T-score <-2.0 for either spine or~     hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus~     risedronate orally. Moderate-risk (M) pts (T-score <-1.0 for spine or hip but -2.0 at both~     sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts~     with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive~     anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are~     assessed at baseline, 12, and 24 months.~   "
210199|NCT00809471|"~     This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to~     placebo in diabetic men with mild to severe erectile dysfunction.~   "
210200|NCT00809458|"~     The purpose of this study is to find out if vitamin E can help treat prostate cancer. Vitamin~     E acts primarily as an anti-oxidant. By decreasing the oxidation in the cancer cell, the~     tumor cells may die. Vitamin E is a commonly used vitamin that has not been approved by the~     Food and Drug Administration for use in this type of cancer or for any known cancer. This~     study will test the hypothesis that vitamin E, in the setting of an oxidative stress such as~     smoking, can reduce prostate cancer related biomarkers in patients with localized prostate~     cancer in the neoadjuvant setting.~   "
210201|NCT00809445|"~     This is a randomized controlled clinical trial in which adults receiving drug abuse treatment~     will be recruited to participate in a multi-center HIV testing and counseling study. The~     purpose of this study is to assess the relative effectiveness of three HIV testing strategies~     on increasing receipt of test results: (1) on-site HIV rapid testing with brief,~     participant-tailored prevention counseling, (2) on-site HIV rapid testing with information~     only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness~     of the three testing strategies in reducing HIV risk behaviors.~   "
210202|NCT00809432|"~     Exposure to air pollution is an important risk factor for cardiovascular morbidity and~     mortality, and is associated with increased blood pressure, reduced heart rate variability,~     endothelial dysfunction and myocardial ischaemia. The study objectives were to assess the~     potential cardiovascular benefits of reducing personal particulate air pollution exposure by~     wearing a facemask in healthy volunteers.~   "
210203|NCT00809419|"~     The objective of the MERITAGE Trial is to evaluate the safety and efficacy of focal delivery~     of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated~     with wet age-related macular degeneration (AMD) in patients that require persistent~     injections of Anti-VEGF therapy to maintain an adequate response to treatment.~   "
210204|NCT00809393|"~     Cardiac surgery with CardioPulmonary Bypass (CPB) exposes to per and postoperative bleeding,~     and may lead to allogenic blood transfusion re-intervention and many adverse outcomes.~     Prophylactic use of tranexamic Acid (TA) has been shown to decrease blood loss and blood~     transfusion during cardiac surgery.There currently are multiple dosing regimens for TA for~     cardiac surgery.Preliminary dose-response study has shown that low prophylactic dose of TA~     would be as accurate for haemostatic efficacy as higher dose.~      The primary objective of this tri-center, prospective, double-blinded, randomised trial is to~     compare two administrations and dosing regimens of TA during cardiac surgery with CPB on the~     perioperative blood loss.~      In addition to the clinical study, a pharmacokinétic/pharmacodynamic study will be conducted.~      Patients are divided in two groups: low and high risk surgery. Methods: After written~     informed consent, patients are randomly assigned to one of the two treatment groups. The low~     dose TA group is: 10 mg/kg TA given over 15 min, followed by an infusion of 1 mg/kg/h~     throughout the operation, and 1 mg/kg into the CPB prime volume. The high dose group is :30~     mg/kg TA given over 15 min, followed by an infusion of 16 mg/kg/h throughout the operation,~     and 2 mg/kg into the CPB prime volume. Hemodynamic and anaesthesia care will be as usual. A~     blood salvage device will be systematically used. The triggers for transfusion will be: red~     blood cells: haemoglobin less than 8 g/dl or 6 g/dl during CBP; Plasma: PT less than 50% or~     INR more than 1.5; platelets: platelets count less than 50/70 G/mm3; fibrinogen: fibrinogen~     less than 1g/l . All patients will receive standard anaesthesia and perioperative care.~      In 60 consecutive patients in the principal investigator center, 5 blood samples will allow~     to assess the plasmatic concentration of tranexamic acid at different time of the surgery~     procedure:~        1. Baseline~        2. 5 min after the loading dose~        3. 10 min after the beginning of bypass~        4. at the discontinuation of the infusion~        5. 1 hour after the discontinuation Plasmatic dosage will be assessed using a high~          performance liquid chromatography technique.~      Patients will be stratified in two groups for the statistical analysis; low and high risk~     surgery. Analysis will be in intention to treat. 300 patients should be recruited in each~     group to detect an absolute difference of respectively 10% (low risk cardiac surgery) and 20%~     (high risk cardiac surgery) in the number of patients exposed to allogenic blood transfusion~     between patients receiving high dose TA regimen and those receiving low dose TA regimen,~     assuming a power of 80% and a two-tailed value less than 0.05.~   "
210205|NCT00809380|"~     Though much attention has been given to the practice of parental presence during invasive~     procedures in children in the ED, few studies have examined the patient's perspective. The~     only study to have addressed this issue used a single visual analog scale, which is not a~     well validated tool to assess children's distress level. Furthermore, no studies have~     assessed parental presence during fracture reduction; only a few incidental cases were~     reported in the literature. Finally, most studies evaluating parental presence had~     methodological limitations because of the absence of a control group.~      The investigators seek to assess whether parental presence during fracture reduction under~     sedation, in children 8 to 18 years of age, decreases anxiety levels in both parents and~     children.~   "
210206|NCT00809367|"~     The goal of this research study is to determine if it is feasible to collect leukemia cells~     from patients ahead of time (before they undergo further treatments) so that these cells~     (after being radiated so they will no longer grow or divide) can be given back to them as a~     cancer vaccine if/after the participant receives a bone marrow or blood stem cell transplant~     in the future. The purpose of the research study will be to collect, freeze and store~     leukemia calls from participants blood or bone marrow. This study is a companion study to a~     vaccine study.~   "
210207|NCT00809354|"~     The purpose of this study is to investigate the long-term analgesic efficacy and safety of~     tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing~     partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID)~     therapy.~   "
210208|NCT00809341|"~     This research is being done to see if a PET scan that is obtained after 3 cycles of a~     standard chemotherapy regimen can help guide treatment for patients with a blood disease~     called Non-Hodgkin's Lymphoma.~      The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the~     CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen~     can cure about half of patients with lymphoma, but in many others disease relapses (comes~     back). Relapses are generally treated with more chemotherapy.~      We believe that a PET scan (a type of imaging study that lights up in areas of cells with~     high activity such as lymphoma), may identify patients early who are at high risk of relapse.~      The purpose of this research study is to find out if people whose treatment is changed early~     to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have~     longer remissions than they would if they did not receive that high dose chemotherapy.~   "
210209|NCT00809328|"~     Azithromycin has high rates of clinical response and eradication, wide spectrum of activity,~     so we suppose the development of the azithromycin injectable formulation in Japan would~     deliver benefit to patients of community acquired pneumonia.~   "
210210|NCT00809315|"~     The purpose of this study is to develop, standardize and provide a preliminary test of a~     novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized~     that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which~     consists of therapeutic skills groups and mentoring, will improve mental health, social,~     academic and behavioral functioning and reduce youths' initiation of, and participation in,~     problem behaviors.~   "
210211|NCT00809302|"~     This is a clinical trial to be conducted at multiple Parkinson Study Group (PSG) sites in the~     USA. Patients with early Parkinson disease will be randomly allocated to one of 4 arms in the~     study. The 4 arms include 3 arms with different doses of aplindore MR tablets and 1 placebo~     arm. The study drug will be taken twice a day (BID). The study is blinded and neither~     subjects, nor the investigators, will know what treatment the subject is receiving.~     Investigational study drug will be adjusted to the assigned dosage and then maintained at~     that dosage for the balance of the 12 week follow-up period. The entire study will take about~     13 weeks. The study will assess the safety and tolerability of aplindore and measure how~     effective aplindore is in improving movement and other effects of Parkinson disease.~   "
210212|NCT00809289|"~     This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the~     effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.~   "
210213|NCT00809276|"~     The purpose of this research is to find the most effective and least toxic way to prevent~     GVHD after BMT.~   "
210214|NCT00809263|"~     In a homeopathic drug proving a homeopathically prepared substance is administered to healthy~     volunteers in order to produce the symptoms specific to that substance and thereby reveal its~     inherent curative powers. During a homeopathic drug proving the goal is to provoke temporary~     symptoms (or artificial illness) associated with the homeopathic medication. These symptoms~     are then arranged to form a symptom pattern or 'remedy picture' which is specific to that~     particular homeopathic substance and provides the basis for a better understanding of the~     possible effects of that homeopathic remedy in patients.~   "
210215|NCT00809250|"~     The purpose of this research study is to determine if the GM-K562/leukemia cell vaccine can~     be safely given soon after allogeneic marrow or blood stem cell transplant. The~     GM-K562/leukemia cell vaccine is composed of a cultured cell line that has been genetically~     modified to secrete GM-CSF, a naturally occuring substance in the body that stimulates the~     immune system. The vaccine is a mixture of the GM-K562 cells (radiated to prevent them from~     growing in the participants body) with the participant's previously frozen and killed~     leukemia cells. By mixing the GM-K562 with the leukemia cells, we would like to study whether~     this vaccine combination will stimulate the participant's new immune system to recognize and~     fight against their MDS/AML cancer cells.~   "
210216|NCT00809237|"~     Non-small cell lung cancer (NSCLC) is the most common cause of cancer mortality in men and~     women in Singapore.Chemotherapy and biologically targeted agents can extend survival only~     modestly for these patients; therefore, discovery of novel ways to prolong the disease course~     is a top research priority.~      The epidermal growth factor receptor (EGFR) signaling pathway plays a central role in the~     neoplastic transformation of NSCLC and promotes cancer cell survival, metastasis, and~     angiogenesis. The predominance of EGFR signaling in NSCLC makes the pathway an attractive~     candidate for the development of targeted therapeutics. Over the last three years, the FDA~     has approved two drugs for salvage treatment of NSCLC, gefitinib (Iressa ®, formerly known as~     ZD1839) and erlotinib (Tarceva ®, formerly known as OSI-774). Both are small molecule~     orally-bioavailable tyrosine kinase inhibitors (TKIs) of the EGFR TK domain, and have been~     shown to improve survival compared to placebo in asian patients when administered after~     failure of first or second line chemotherapy for advanced NSCLC.~   "
210217|NCT00809224|"~     The purpose of this study is to track areas of the brain, via functional magnetic resonance~     imaging (fMRI), that retain structural and functional integrity throughout the lifespan of~     people with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.~   "
210218|NCT00809211|"~     RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well nilotinib works in treating patients with~     newly diagnosed chronic phase chronic myelogenous leukemia.~   "
210219|NCT00809198|"~     The effect of Kynex versus Refresh Plus in subjects with mild to moderate dry eye.~   "
210220|NCT00809185|"~     RATIONALE: RAD001(Everolimus) may stop the growth of cancer cells by blocking some of the~     enzymes needed for their growth and by blocking blood flow to the cancer.~      PURPOSE: This phase II trial is studying how well RAD001(everolimus) works in treating~     patients with myelodysplastic syndromes.~   "
210221|NCT00809172|"~     The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to~     phototherapy and cyclosporine with the risks respectively of either carcinoma, or~     hypertension or nephropathy.~      Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an~     open retrospective study.~      We want to confirm our observations: a non inferiority multicenter clinical trial,~     methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.~   "
210222|NCT00809159|"~     Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as~     treatment of moderate to severe ankylosing spondylitis (AS).~   "
210223|NCT00809146|"~     The goal of this non-inferiority trial is to determine which type of routine care is the best~     for paramedics to stop someone from seizing.~   "
210224|NCT00809133|"~     The main purpose of this study is to assess the optimum dose of the following medications~     when they are given together:~        -  BIBW 2992 and paclitaxel (Taxol)~        -  BIBW 2992 and paclitaxel and bevacizumab (Avastin)~        -  BIBW 2992 and carboplatin~        -  BIBW 2992 and paclitaxel and carboplatin The effect of the different drug combinations~          will also be assessed.~   "
210225|NCT00809120|"~     The study was designed to test the following hypothesis~      Patients with high cardio-respiratory response to electrostimulation (ES), high perception of~     pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more~     difficulties to increase intensity during training).~   "
210226|NCT00809107|"~     The rational of the study is to assess the implantation, pregnancy and live birth rates after~     the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone~     (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG)~     for final oocyte maturation and ovulation.~   "
210227|NCT00809094|"~     This Phase IIB proof-of-concept study would examine the effects of an investigational product~     called N-acetylcysteine (NAC) on the basic processes that cause inflammation in CF lung~     disease. We hope to learn more about the causes of lung disease in cystic fibrosis by~     studying the characteristics of the inflammation in the lungs of patients who have CF.~   "
210228|NCT00809081|"~     Pancreaticoduodenectomy is associated with a high incidence of postoperative complications.~     These postoperative complications could delay postoperative resumption of adequate oral~     intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very~     limited. Method of Nutritional support (Enteral feeding or total parenteral support)after~     pancreaticoduodenectomy is controversial.~        1. To evaluate whether early enteral nutrition may be a suitable alternative to total~          parenteral nutrition~        2. To evaluate whether enteral feeding improve nutritional status after~          pancreaticoduodenectomy~   "
210229|NCT00809068|"~     Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%.~      This study aims to study the effects of fenofibrate on HDL and subfractions in women taking~     tibolone.~   "
210230|NCT00809055|"~     Over the last 30 years the survival rates for babies born prematurely have improved greatly~     with research. As these babies grow up, we have found that many of the premature babies have~     learning and movement problems. The purpose of this research is to learn why premature~     infants are at risk for learning disabilities and movement problems later in childhood and~     whether this is changed by caffeine therapy. Caffeine is often used in premature babies to~     help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive~     caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown~     that caffeine therapy given to premature babies reduces their disabilities.~      We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance~     imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine~     in high doses enhances protection of the developing brain. Just as we monitor the heart and~     lungs to improve our care of premature babies, we wish to monitor the brain so that we can~     understand how to improve our care for the brain.~   "
210231|NCT00809042|"~     The purpose of this study is determination of the efficacy of combination of hydroxyurea with~     L-carnitine or magnesium in improving hematologic parameters and cardiac status in patients~     with β-thalassemia intermedia in comparison with hydroxyurea alone .~   "
210232|NCT00809029|"~     Study part-1~      GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones~     secreted by specialized cells of the gastrointestinal tract in response to ingestion of~     nutrients. Data emerging from studies in animal models and cultured human fat cells support a~     physiological role for GIP in the adipose tissue metabolism which may contribute to the~     pathogenesis of obesity.~      The proposed study will shed more light on the interactions between gut hormones and adipose~     tissue. For this pilot study, male subjects fulfilling the inclusion criteria will be given~     GIP or placebo infusions in a randomized manner. Fat tissue biopsies will be obtained from~     all subjects during both visits, once in the basal state (before the start of the~     peptide/placebo infusion) and then repeated at the end of the period of infusion.~      Study part-2~      Surgery represents the most effective therapeutic modality for morbid obesity. Resolution of~     type 2 diabetes mellitus (T2DM) has been consistently observed as an additional benefit of~     surgical treatment of obesity. The mechanisms underlying the dramatic effects of surgery on~     insulin sensitivity and β-cell function are poorly understood. Bariatric surgery (gastric~     bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion from~     the physiological intestinal routes with subsequent profound modification of gut hormone~     secretion~      We hypothesize that restoration of GIP action after bariatric procedures plays a cardinal~     role in the improvement and/or restoration of diabetes, we propose to study patients (both~     sex)with morbid obesity and T2DM within 3 months after their surgery. Their responses will be~     compared to those of BMI matched control subjects with normal glucose tolerance~   "
210233|NCT00809016|"~     RATIONALE: Imaging procedures, such as PET scans, may determine the extent of cancer and help~     doctors plan radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor~     cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus~     thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses~     over a shorter period of time, may kill more tumor cells and have fewer side effects.~     Specialized radiation therapy that delivers a high dose of radiation directly to the tumor~     may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This clinical trial is studying PET scans to see how well they work in patients with~     head and neck cancer who are undergoing 3-dimensional conformal radiation therapy and~     intensity-modulated radiation therapy.~   "
210234|NCT00809003|"~     This project will examine the similarities and differences of the ocular surface and tear~     film in patients with Sjogren's syndrome related to dry eye, severe dry eye and those who do~     not have dry eye. This knowledge will help clinicians understand the processes that create~     these dry eye conditions and will strengthen the treatment and management strategies that~     will be used. The subjects will participate in a series of dry eye tests that they have~     already experienced in clinic, along with the gathering of tear samples and surface cells.~     These tissues will then be analyzed at a distant site.~   "
210235|NCT00808990|"~     Nonalcoholic Fatty Liver Disease (NAFLD) has been suggested to be the most common cause of~     chronic liver disease in the general population in the Western World. In advanced stages of~     NAFLD, steatohepatitis (NASH) develops characterized by: steatosis, inflammation, and~     fibrosis progressing to cirrhosis in some patients. The knowledge of the role of small~     intestinal bacterial overgrowth (SIBO) in the pathogenesis of NASH has led to the proposal of~     probiotics as a therapeutic strategy for this disorder.~   "
210236|NCT00808977|"~     The purpose of the study is to obtain a first clinical assessment of the safety of~     dersalazine sodium in ulcerative colitis patients with mild to moderate disease.~   "
210237|NCT00808964|"~     This is a Phase 2, multicenter, open-label, single-arm, sequential cohort study to be~     conducted in up to 30 subjects. The study will evaluate subjects undergoing primary,~     elective, off-pump CABG surgery with median sternotomy.~   "
210299|NCT00808145|"~     This study will look at the safety and efficacy of treating advanced hepatocellular carcinoma~     in patients who have not yet received systemic chemotherapy. Previous local treatment of~     hepatic lesions is permitted The treatment will use a combination of three FDA approved~     chemotherapy drugs, Gemcitabine, Cisplatin and Sorafenib. Sorafenib is FDA approved for the~     treatment of hepatocellular cancer, gemcitabine and cisplatin are not approved for the~     treatment of hepatocellular cancer.~   "
210353|NCT00807430|"~     To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms~     and at the jaw muscle activity during sleep.~   "
210238|NCT00808951|"~     Resistance to antimalarial drugs represents a major obstacle for controlling malaria in~     endemic countries, so that most sub-Saharan countries have changed their antimalarial drug~     policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for~     uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but~     there are still little available data on safety and efficacy of these treatments in Burkina~     Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of~     recurrent malaria infections during a 28-day follow up period. Thus, this study aims at~     comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing~     their in vitro sensitivity, in patients with recurrent infection, with the results obtained~     in vivo.~   "
210239|NCT00808938|"~     Electro convulsive therapy (ECT) remains the only established therapy for the large~     percentage of patients with depression who fail to respond to standard treatments. It is~     commonly used but has substantial problems including the occurrence of cognitive side effects~     that are often highly distressing for patients. The development of a new treatment with~     similar efficacy but which minimises these side effects would have great clinical value. One~     highly promising possibility is magnetic seizure therapy (MST). MST involves replacing the~     electrical stimulation used in ECT with a magnetic stimulus. This appears to be able to~     produce similar clinical effects but without the disabling cognitive side effects related to~     ECT. However, substantive trials using the newest MST equipment are required. Due to the~     rarity of the equipment available so far, these are only being undertaken in a handful of~     places internationally and no research with MST has occurred in Australia. The investigators~     are fortunate to have been able to obtain one of the very limited number of MST devices~     available internationally and are proposing a pilot study of this technique. Conduct of a~     successful pilot study would be strong justification for an application for a large~     head-to-head MST - ECT comparison trial. Should MST be shown to have similar efficacy to ECT~     but with reduced side-effects, it is envisioned that it could rapidly replace ECT in clinical~     practice throughout Australia and indeed internationally with substantial ongoing benefits to~     patients. These would include enhanced use of it as an outpatient therapy as well as the~     reduction in side-effects.~      The study will be an open label trial of MST in 15 patients with treatment resistant~     depression who have been referred for ECT. All patients will undergo a dose titration~     procedure to establish seizure threshold, six MST treatment sessions will then be provided at~     120% of threshold. If the patients have not achieved a 50% reduction in their depressive~     symptoms (as measured by the Montgomery Asberg Depression Rating Scale rating scale) patients~     will receive another 12 sessions. MST will be administered three times a week. Patients will~     undergo a series of assessments to determine both the efficacy of MST and the cognitive~     outcomes. The primary outcome measure will be the MADRS measure of depression severity. The~     investigators will additionally measure patient rated depression severity and cognitive~     functioning The overall aim of the current project is to, via an open label pilot trial,~     investigate the clinical response to magnetic seizure therapy in patients with treatment~     resistant depression who have been referred for electroconvulsive therapy.~   "
210240|NCT00808925|"~     There is growing evidence to conclude that part of the cascade leading to heatstroke is~     related to an inflammatory reaction triggered by the heat stress. The reduced ability to~     sustain heat stress - heat intolerance is also attributed to over-expression of~     inflammatory cytokines. Acclimation to heat improves human sustainability to heat and is a~     leading protective factor against heat stroke. The investigators hypothesize that the lower~     stress encountered during the process of acclimation to heat will be reflected by an~     over-ride in the expression of anti-inflammatory over the pro-inflammatory cytokines. This,~     in turn will attenuate the pathological cascade leading to heat stroke.~   "
210241|NCT00808912|"~     The purpose of this study is to examine if the ingestion of a standard dose of sildenafil~     enhances the athletic performance of competitive athletes when exercising in a high pollutant~     environment verses a low air pollutant environment.~   "
210242|NCT00808899|"~     A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan;~     cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and~     topotecan (TPT) followed by and additional six courses of induction chemotherapy and then~     intensification with autologous hematopoietic stem cell transplantation. The first five~     courses of induction chemotherapy will also evaluate the feasibility of combining weekly~     temsirolimus with these standard chemotherapy combinations. This will be followed by 16~     months of oral maintenance therapy with eight months of 13-cis-retinoic acid and then eight~     months of oral topotecan.~   "
210243|NCT00808886|"~     Hypothesis: There is no difference between pentacam scheimpflug system and locs3 in grading~     of cataract.~      Major aims:~        1. research the efficiency of pentacam scheimpflug system in lens density measurment.~        2. To compare the pentacam with the locs3 in grading of cataract.~   "
210244|NCT00808873|"~     Compared to a treatment-as-usual group, providing brief mental health education to suicide~     attempters from rural parts of China at the time of their treatment in the emergency~     departments of general hospitals or local clinics and 6 home-visits (FOR those subjects WITH~     PHONES refuse home visits, THE INTERVIEWS WILL BE CONDUCTED OVER THE PHONE) over the twelve~     months after the attempt demonstrate continuing concern about the attempters ('befriending'),~     strengthen their social support networks and improve their problem-solving skills will~     significantly reduce their hopelessness, the severity of depressive symptoms, and level of~     suicidal ideation.~   "
210245|NCT00808860|"~     The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract,~     administered as a tea, as add-on therapy with Sulfonylurea (SU) in drug-naive patients with~     newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg~     and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with~     gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g~     twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4~     and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver~     function.~   "
210246|NCT00808834|"~     The purpose of this study is to compare subjective responses to two contact lenses after 15~     minutes of wear.~   "
210247|NCT00808821|"~     The study is aimed at assessing pharyngeal and nasopharyngeal Streptococcus pneumonia~     carriage and pharyngeal Group A streptococcus carriage among field units new recruits.~   "
210248|NCT00808808|"~     The purpose of this study is to determine, among adults and in the total population, the~     effects of offering a choice of FluMist or trivalent inactivated vaccine (TIV) in the~     employer setting when compared to a control group.~   "
210249|NCT00808795|"~     -  Contrast-induced nephropathy (CIN) is the third most common cause of hospital acquired~          acute kidney injury, accounting for 10% of all cases.~        -  The pathophysiology of CIN is unclear. Possible mechanisms involve~             1. Renal tubular injury by oxygen free radicals~             2. Reducing renal blood flow which leads to acute tubular necrosis. Since~               N-acetylcysteine is an antioxidant as well as a vasodilator, it may work in two~               distinct ways, by preventing reduction in renal blood flow or contrast-induced~               oxidative damage.~        -  The purpose of this study is to evaluate the efficacy of N-acetylcysteine compared to~          placebo for the contrast-induced nephropathy prevention.~   "
210250|NCT00808782|"~     Theory of mind (ToM) refers to the ability to infer others mental states. It includes a~     recognition that other individuals experience thoughts, feelings, intentions, and desires~     that may be different to our own. ToM is often impaired among individuals with an autism~     spectrum disorder (such as autism and Asperger's disorder), and may underlie aspects of~     social dysfunction in this population. Indeed, it has been suggested that impaired ToM is the~     core deficit of autism and Asperger's disorder.~      Imaging studies suggest that the bilateral medial prefrontal cortex, the most important brain~     region in ToM processing, is underactive in autism. The current study examines whether~     repetitive transcranial magnetic stimulation (rTMS) to the bilateral medial prefrontal cortex~     can modulate ToM ability among healthy adults, and improve ToM ability among adults with~     autism or Asperger's disorder. With the prevalence of autism increasing, there is a clear~     need to develop appropriate therapeutic interventions to improve social functioning.~      This study involves a double-blind study using high-frequency rTMS in an attempt to improve~     ToM among adults with either autism or Asperger's disorder. Theory of mind will be measured~     using behavioural tasks that require the participant to infer what someone is thinking or~     feeling by observing their behaviour. These tasks will administered both before and after~     rTMS to determine whether any change in theory of mind has occurred.~      Thirty adults with either autism (n = 15) or Asperger's disorder (n = 15) will initially~     undergo functional and structural MRI to determine the site on the scalp that lies over the~     medial prefrontal cortex (to which rTMS will be administered). They will then attend our lab~     each consecutive weekday for a two-week period, during which they will 15 minutes~     high-frequency (5 Hz) rTMS (either active or sham) to the medial prefrontal cortex. ToM and~     clinical measures will be collected before the first session, soon after the last session,~     and one month after the last session.~      Based on prior imaging data, it is expected that high-frequency rTMS (compared with sham~     rTMS) to the medial prefrontal cortex will improve ToM ability and reduce social dysfunction~     among adults with autism or Asperger's disorder. Should these hypotheses be supported, it~     will indicate the suitability of rTMS as a neurobiological intervention designed to improve~     ToM and social function among individuals with autism and related disorders.~   "
210251|NCT00808769|"~     The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on~     gastric acid suppression.~   "
210252|NCT00808756|"~     The purpose of this project is to study the effect of fermentable carbohydrates in the~     nutrition of healthy infants.~   "
210253|NCT00808743|"~     Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous~     Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is~     to determine wether celecoxib combined with ursodeoxycholic acid is an effective~     chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in~     patients with FAP.~   "
210254|NCT00808730|"~     Asthma is a frequent disease characterized by bronchial hyperresponsiveness, inflammation and~     remodelling. Bronchial remodelling is an abnormal repair process that contributes to the~     development of poorly reversible airway narrowing. It can appear very early in the evolution~     of the disease and involves an increased mass of bronchial smooth muscle (BSM). The mechanism~     of such an increase has been related with an increase in smooth muscle cell proliferation.~     Recently, we have demonstrated that, BSM increased proliferation is induced by an enhanced~     mitochondrial biogenesis in severe asthma (T. Trian et al. J Exp Med 2007). The objective of~     this study is to investigate the role of smooth muscle cell mitochondria in non severe asthma~   "
210255|NCT00808717|"~     Although statin prior to PCI has favorable effects in stable angina and ACS except ST~     elevation MI (STEMI), there have been few studies for STEMI. Celik T et al. reported in~     patients with STEMI that prior statin use may improve coronary blood flow after PCI in~     patients with AMI, possibly by its beneficial effects on microvascular function. But this~     study was retrospective, non-randomized study and evaluated the effects for chronic statin~     therapy not acute high dose effect. Therefore, the investigators investigated whether acute~     high-dose statin prior to primary PCI in ST segment elevation myocardial infarction can have~     beneficial effect or not for periprocedural period and 30 days-cardiac events.~   "
210256|NCT00808704|"~     Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and~     mortality in term and preterm neonates, accounting for 23% of neonatal deaths globally.~     Although many neuroprotective strategies appeared promising in animal models, most of them~     have failed clinically. Erythropoietin (EPO) is an endogenous cytokine originally identified~     for its role in erythropoiesis. Clinical trial has demonstrated the safety and efficacy of~     recombinant human erythropoietin (r-hu-EPO) in the prevention or treatment of anemia of~     prematurity. To date, there are no reports evaluating possible effects of EPO on neonatal~     HIE.~   "
210257|NCT00808691|"~     As medicine advances, many lives can be saved in the intensive care unit. However, when~     multiple organ failure occurs, the mortality rate of patients increases dramatically.~     Therefore, the major goal in the intensive care unit is to prevent the occurrence of multiple~     organ failure. The sepsis protocol and early goal directed treatment have great effects to~     reduce development of multiple organ failure and to decrease the mortality rate. However,~     sometime the condition of patient deteriorated in spite of both the mean blood pressure and~     mixed venous oxygen saturation are normal. Some experts recognize that there might be~     microcirculatory dysfunction of tissue or organ. The dysfunction of microcirculation might~     due to vasoconstriction or microthrombosis. Vasoconstriction might result from systemic~     inflammation, reactive oxygen species, or dysfunction of synthesis of NO (nitric oxide).~     Microthrombosis might result from systemic inflammation, reactive oxygen species, imbalance~     of coagulatory system, or damage of endothelial cell.~      In clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute~     lung injury, and acute respiratory distress syndrome. This study tries to investigate the~     relation between oxidative stress and microcirculation. Furthermore, the investigators will~     try to investigate the correlation between the severity of oxidative stress and~     microcirculatory dysfunction and the severity of disease and prognosis. The investigators~     hope this study will help them to figure out the picture of disease progression of patients.~     It may conduct further study to modulate the oxidative stress, to improve the~     microcirculatory function, and finally to improve the outcome of patients.~   "
210258|NCT00808678|"~     The purpose of this study is to evaluate the safety and compare the pharmacokinetic~     parameters from the fixed dose combination ABT-143 relative to that from the~     co-administration of the two monotherapies.~   "
210259|NCT00808665|"~     Major lumbar spine surgery causes inflammation, soreness and swelling that can delay~     discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory~     effects. This study will evaluate whether DEX can help get patients out of the hospital~     faster after major spine surgery by reducing the inflammation associated with the procedure~     itself. A separate part of the study will evaluate the blood levels of some specific~     indicators of inflammation called cytokines. Measuring cytokines before and after surgery~     will aid in determining if DEX has altered the inflammatory response.~   "
210300|NCT00808132|"~     The purpose of this research study is to evaluate the safety and effectiveness of this~     investigational drug for the treatment of menopausal symptoms while protecting the~     endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject~     participation will last approximately 14.5 months.~   "
210260|NCT00808652|"~     The relation between obesity and ischemic heart disease (IHD) is under considerable debate.~     The reduction in all-cause mortality and, more specifically, the reduction in cardiac-related~     mortality seen after weight-loss surgery, may be due to regression or slowing developement of~     subclinical IHD. Function of cells lining the arteries (endothelium) is closely related to~     the state of IHD and its measurement can serve as a surrogate marker for the existence and~     severity of IHD. The investigators hypothesize that the prevalence of undiagnosed IHD in the~     morbidly obese population is high and that following surgery for weight reduction there is a~     halt in the progression, or even a regression in its severity.~      The study includes measurement of endothelial function before and after weight-reducing~     surgery.~   "
210261|NCT00808639|"~     The purpose of this research study is to test the effectiveness of neoadjuvant dose-dense~     methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) in combination with~     pegfilgrastim followed by radical surgery in patients with muscle-invasive urothelial~     carcinoma.~   "
210262|NCT00808626|"~     99mTc-rBitistatin is a radiolabeled polypeptide which is designed to stick to blood clots so~     that the blood clots can be detected by imaging. The purpose of this trial is to evaluate in~     patients the safety of 99mTc-rBitistatin and its ability to locate blood clots in the arms~     and legs.~   "
210263|NCT00808613|"~     The purpose of this study is to evaluate the differences in clinical outcomes between the~     Optetrak® Posterior Stabilized (Optetrak® PS, Exactech, Gainesville, FL) and the Optetrak®~     Hi-Flex™ (Optetrak® HF, Exactech, Gainesville, FL) knee designs. The null hypothesis is~     that there is no difference in postoperative knee flexion between the Optetrak® PS and~     Optetrak® HF groups.~   "
210264|NCT00808600|"~     Lung or combined heart-lung transplantation represents an established treatment strategy for~     patients with end-stage lung disease. Transplantation results in an increased exercise~     capacity, a better quality of life and - depending on the pulmonary disease - a prolonged~     life compared to the natural course of the pulmonary disease. However, even after successful~     organ transplantation, patients realise the often inflated, unrealistic character of their~     previous expectations due to their continuing dependence on medication, regular control~     examinations and a higher risk of infections and allograft rejections. Patients have to cope~     with erupting demands in family, social and work life. It becomes evident that their lives~     have changed forever. In this context, limitations in mental health like depression and~     reduced quality of life (QoL) as well as diminished compliance may emerge or even persist. By~     five years post-transplant, about one-half of the patients meet the criteria of an anxiety~     disorder. Symptoms of a clinically relevant depression or mood disorder occur in 10 to 15 %~     of lung transplant patients.~      In addition, patients after lung transplantation are often in a poor physical condition and~     only hold a reduced functional status. Surgery itself, a prolonged weaning period during~     mechanical ventilation, sepsis, and especially the immunosuppressive medication may~     long-ranging or permanently limit physical activity, further reducing muscle mass and bodily~     function.~      Some positive effects of either psychological coping skills training or supervised exercise~     therapy after lung or heart-lung transplantation on QoL and functional status have been~     described in very few existing pilot studies with small numbers of patients and only~     short-term follow-up. In addition, although clear evidence points to a mutual amplifying~     effect of both psychological training and exercise therapy in patients coping with chronic~     disease, no such study has yet been conducted in the transplantation field.~      Therefore, the aim of the investigators randomised controlled study is to prove the~     differential benefit of a multi-modal resource-activating behavioural training programme~     combined with an intensified exercise training programme on functional status as well as on~     QoL in a four-armed design. The investigators hypotheses are: (H1) The multimodal~     resource-activating behavioural training programme will show better out-comes in the measures~     of global health-related QoL compared to a relaxation group. (H2) Participants in the~     intensified anaerobic exercise training will have better outcomes in the measures of~     exercise-related variables and lung function than the group with moderate aerobic exercise~     training. (H3) Participants in the behavioural intervention programme and the intensified~     exercise training will have better outcomes in the measures of global health-related QoL and~     exercise-related variables compared to the other groups.~   "
210265|NCT00808587|"~     The specific aims for this project are to enroll up to 10,000 subjects who will have their~     genomes surveyed using the Navigenics™ Health Compass technology. The Navigenics Health~     Compass helps you understand what your genetic variants have to say about the future of your~     health, and gives you action steps to take control of your health today. In addition, the~     investigators will assess how the Navigenics Health Compass, results affect lifestyle~     decisions. The phenotyping information that can be analyzed with the resulting Navigenics~     genotype information will assist in identifying genetic variations associated with other~     traits and diseases.~      The uses of molecular markers such as cholesterol and glucose levels to assess disease risk~     are well established in clinical medicine today. Although these tools are useful in screening~     for subclinical disease, their predictive value is limited. Until recently, these molecular~     markers were the best risk assessment and screening tools in existence. Since the completion~     of the Human Genome Project, the era of personalized medicine, which exploits knowledge of~     the genes an individual carries that may predispose him/her to disease, has come to the~     forefront of research.~      The Navigenics Health Compass technology assesses risk for about over 20 common diseases and~     provides subjects with more accurate assessments of their individual predictive risk for~     developing these conditions than traditional biomarkers such as cholesterol and glucose~     levels. This may positively influence changes in lifestyle, as well as decisions to seek~     further medical evaluation associated with preventive strategies.~   "
210266|NCT00808574|"~     The current study was a pilot, double blind, randomized controlled trial to (1) evaluate the~     feasibility of an online obstructive sleep apnea (OSA) screening intervention, (2) estimate~     effect size for planning of future studies, and (3) test the hypothesis that the~     intervention, compared to a control condition, would lead more individuals to discuss OSA~     with their healthcare provider.~   "
210267|NCT00808561|"~     The primary objective of this study is to compare two treatment strategies for establishing~     dialysis access in patients with unsuitable forearm veins for the standard forearm primary~     radio-cephalic arteriovenous fistula also known as the Brescia-Cimino fistula.~   "
210268|NCT00808548|"~     Ask the 4 carers of children with Prader-willi syndrome to disclose their experiences and~     difficulties for searching better management and intervention~   "
210269|NCT00808535|"~     The goal of this research study is to demonstrate that Cardiac Perfusion MRI with Vasomotor~     Stress may serve as a non-invasive and less risky imaging technique for detecting~     non-obstructive perfusion deficits and/or abnormalities in myocardial blood flow (MBF) in~     patients with endothelial dysfunction.~      This is a controlled study, which will enroll approximately 60 subjects (30 diabetics and 30~     non-diabetics to serve as healthy controls), and will include male and non-pregnant females,~     between the ages 18-50 years.~      All eligible participants will sign an informed consent and will complete a Lifestyle~     Questionnaire. They will undergo blood work which includes:~        -  2-hour Oral Glucose Tolerance Test and Fasting Labs for Glucose, Insulin, C-Peptide,~          HbA1c, Creatinine, and Lipid Panel.~        -  Urine Albumin to Creatinine ratio for microalbuminuria.~        -  Serum inflammatory markers: E-selectin, homocysteine, ADMA, VCAM, IL-6, TNFalpha, hs-CRP~          and PAI-1.~      After blood work, all participants will undergo cardiac MR perfusion imaging procedure with~     Cold Pressor Test and Adenosine Stress Test.~   "
210270|NCT00808522|"~     The purpose of the study is to evaluate whether hCG will result in a decrease in breast~     density.~      High breast density has been associated with an increased risk in breast cancer. It has also~     been shown that decreasing density with a drug called tamoxifen has resulted in a decreased~     risk in breast cancer. The investigators are looking at the effect of hCG on breast density~     in people who are at increased risk of developing breast cancer and our theory postulates~     that through the hormonal actions of hCG and tamoxifen there would be a greater reduction in~     breast density in patients who are treated with hCG and tamoxifen versus patients treated~     with tamoxifen alone. Using this data the investigators will be able to hypothesize that the~     treatment of hCG will result in a reduction in breast cancer rates in the population and thus~     make available another drug which can be used to decrease the rates of breast cancer in the~     population~   "
210271|NCT00808509|"~     The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab~     therapy in patients with rheumatoid arthritis who are in stable remission after treatment~     with adalimumab in combination with methotrexate.~   "
210272|NCT00808496|"~     Inflammatory arthritis is a major cause of permanent joint damage. Joint damage causes~     functional disability and physical deformity. Many inflammatory arthritis patients develop~     permanent joint damage within the first two years of disease. Early, aggressive treatment~     with drugs called disease-modifying antirheumatic drugs (DMARDs) is known to reduce how~     quickly this damage occurs. Sometimes, however, even when patients' symptoms are under~     control, the disease continues to cause joint damage.~      This study will determine if magnetic resonance imaging (also known as 'MRI') conducted every~     six months provides arthritis specialists with information to help them better treat~     peripheral inflammatory arthritis patients over the first two years of care. The effect of~     MRI will be compared to 1) the use of x-ray every six months; and, 2) the frequency at which~     these tests are usually used. The study will also determine if differences in treatment~     between the three groups result in differences in the well-being of patients.~      A total of 186 patients with early signs of inflammatory arthritis will be studied. All~     participants will have an MRI and x-ray conducted every six months. One-third of participants~     (62 in total) will only have MRI information sent to their arthritis specialist (MRI group);~     62 will have x-ray information sent (X-ray group); and, the remaining 62 will have x-ray~     information sent only when ordered by the arthritis specialist (Usual Care group). Negative~     disease progression reports will be sent to the arthritis specialist unless intervention~     allocation-specific disease progression is detected. In which case, a report blinded to~     imaging modality will be sent indicating the detection of disease progression relative to the~     last timepoint of progression, or baseline, as applicable. At any point in the study, the~     arthritis specialist can request a clinical MRI or x-ray for any participant.~      Neither the participants nor their doctors will know to which group they are assigned. A~     computer program will randomly assign participants to one of the three groups using a~     technique called minimization. This technique accounts for differences between participants~     that are known to effect disease progression and treatment decisions. Using this technique,~     participants with similar disease will be evenly distributed between the three groups.~      The results of this study will have a direct impact on care for new inflammatory arthritis~     patients. It will determine the benefits, if any, of regular monitoring of disease~     progression with MRI or x-ray. Using tests proven to help treatment decision-making,~     arthritis specialists will improve the care provided to new inflammatory arthritis patients.~   "
210273|NCT00808483|"~     Rehabilitation plays an important part after total hip arthroplasty. In this common practice~     few studies have been performed on this issue.~      The aims of this study were:~        1. to examine the immediate effects of a walking skill training program on walking, stair~          climbing, balance, self-reported physical functioning physical functioning, pain and~          self-efficacy compared to a control group without supervised physiotherapy~        2. to examine whether the effects persisted 12 months after surgery~   "
210274|NCT00808470|"~     Noise-induced hearing loss (NIHL) is a significant clinical, social, and economic issue.~     Studies in animals have allowed us to identify mechanisms contributing to NIHL, including~     direct mechanical trauma, free radicals formed in association with metabolic stress, and~     reduced blood flow. A combination of antioxidant vitamins (beta-carotene, and vitamins C and~     E) and the mineral magnesium (which acts in part as a vasodilator but also as an antioxidant)~     is highly effective in preventing NIHL in animals. These studies evaluate efficacy of this~     intervention in humans.~      Hypothesis: Treatment with these micronutrients provides safe, effective attenuation of acute~     hearing changes induced by exposure to real-world sounds producing temporary (non-permanent)~     or permanent hearing changes induced by exposure to real-world sounds.~      Experiment 1: Digital Audio Player studies (University of Florida, Gainesville). Prevention~     of *temporary* elevations in hearing thresholds, induced by exposure to moderately loud~     music, will be measured. Subjects will be 70 young adults with equal numbers of male and~     female participants.~   "
210275|NCT00808457|"~     The study of a large number of patients (at least 200 patients) from several European centres~     aims to investigate the value of chest ultrasound in diagnosing and checking the course of~     pneumonia as compared to a chest X-ray film in two planes and - in case of a controversial~     X-ray finding- as compared to low-dose CT.~      An X-ray finding is regarded controversial, if infiltrates cannot be reliably excluded or not~     reliably represented and if a definite diagnosis is, thus, not possible. A low-dose CT is~     indicated even in case of a positive chest ultrasound and negative X-ray finding. Sonographic~     recording and characterization of pneumonic infiltrates is performed both at the time of~     diagnosing and in the further course under therapy.~   "
210276|NCT00808444|"~     The purpose of the present study is to demonstrate that the changes in the manufacturing~     process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no~     clinical impact and that the immune responses are non-inferior to the immune responses~     induced by the clinical lot. The study will be conducted in Singapore and Malaysia.~   "
210277|NCT00808431|"~     Preventing the onset of pediatric obesity and diabetes in Latino families~      The investigators will conduct a randomized controlled trial of a family-based community~     centered intervention. One-hundred Latino families with children ages 3-5 will be randomly~     allocated to either the intervention group (a 3-month skills building program to improve~     nutrition and aerobic activity for child-parent dyads) or a control group (literacy~     promotion). Through an active partnership with Nashville Metro Parks and Recreation and the~     Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will:~     1) Implement an intervention for Latino families with young children that includes parent~     training, behavior modification training, nutrition education, and physical activity~     promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3)~     Evaluate how this intervention affects parenting practices for Latino families to improve~     nutrition and physical activity; and 4) Evaluate the ability to link families into a~     pediatric medical home if they have none identified. By developing innovative family-focused~     interventions, finding solutions to health conditions such as obesity and diabetes could be~     realized-con la familia.~   "
210278|NCT00808418|"~     This aim of this study is to determine the safety and tolerability of elesclomol sodium at~     escalating doses (ultimately identifying the maximum tolerated dose) when combined with a~     fixed dose of docetaxel and concomitant prednisone. This study will also characterize the~     pharmacokinetics of elesclomol and docetaxel.~   "
210281|NCT00808379|"~     At Tata Memorial Hospital 50% of the patients present in the locally advanced stage which is~     technically unresectable, or that is beyond the realm of a potentially curative surgical~     resection. The evaluation of treatment approaches for these tumors is hampered by the absence~     of any substantial randomized studies and the heterogeneous nature of the tumors at~     presentation.~      The management of these tumors has changed over the years, there is emphasis on neoadjuvant~     chemoradiation therapy, trying to convert a tumor that is initially unresectable to one that~     is potentially curable by surgery. But only 70-80% of the patients are able to complete this~     treatment without any significant treatment breaks.~      Dose escalated treatment with radiotherapy in locally advanced and unresectable rectal~     cancers have been tried in many small series with good results and lesser toxicity.~      Comparison outcome between the two arms will indicate the relative efficacy and toxicity of~     neoadjuvant concurrent chemoradiation vs boosted radiotherapy alone in downstaging of~     advanced cancers.~   "
210282|NCT00808366|"~     The purpose of the study is to evaluate the efficacy of RV4104A ointment versus~     bifonazole-urea ointment for the complete removal of the clinically infected nail plate area~     in patients with toenail onychomycosis.~   "
210283|NCT00808353|"~     The ARIC study is a prospective epidemiologic study conducted in four U.S. communities and~     designed to investigate the etiology and natural history of atherosclerosis, the etiology of~     clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care~     and disease by race, gender, location, and date.~   "
210284|NCT00808340|"~     The primary purpose of the study is to compare the performance of three soft bifocal contact~     lenses in terms of the vision provided by the lenses.~   "
210285|NCT00808327|"~     The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal~     anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the~     most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North~     America. Another drug named fentanyl is the most commonly used narcotic. This study will look~     at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal~     anesthetic with 12mg of bupivacaine and 15ug of fentanyl.~   "
210286|NCT00808314|"~     Lexiscan(TM) has ideal properties for Rb-82 PET imaging and the stress response it invokes~     may offer multiple advantages for the diagnosis of coronary disease and functional~     abnormalities. The goal of this investigation is to establish quantitative equivalence of~     Lexiscan(TM) rest/stress Rb-82 PET images to dipyridamole rest/stress images.~   "
210287|NCT00808301|"~     In many Northern European countries oat-based products have been used in the dieto-therapy of~     coeliac disease for many years.~      The purpose of this study is to evaluate clinical tolerance and liking of gluten-free~     products containing oatmeal from a specific oat variety (not contaminated with gluten) in a~     sample of Italian celiac patients in pediatric age.~   "
210288|NCT00808288|"~     To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung~     disease (COPD)~   "
210289|NCT00808275|"~     The purpose of this study is to determine the role of~        1. dietary calcium in fecal fat loss and the association between lactose maldigestion,~          dietary calcium level and source, and weight loss induced by caloric restriction.~        2. caloric restriction on biomarkers of inflammation and oxidative stress~   "
210290|NCT00808262|"~     Evaluation of the safety and the immune response induced by active immunization through a~     TNFa kinoid in patients with Crohn's disease.~   "
210291|NCT00808249|"~     The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe~     and effective in the treatment of generalized anxiety disorder.~   "
210292|NCT00808236|"~     The purpose of the study was to demonstrate the safety and feasibility of early intranasal~     cooling prior to return of spontaneous circulation (ROSC) in the emergency medical services~     (EMS) environment. It was hypothesized that cooling during the resuscitation attempt would~     increase ROSC and subsequent survival. The study was not powered to demonstrate~     statistically-significant differences in any outcome parameter, but was intended as an~     exploratory study only.~   "
210293|NCT00808223|"~     To establish the safety of alefacept when administered to adolescent subjects with moderate~     to severe psoriasis.~   "
210294|NCT00808210|"~     This is a Phase II, randomized, active-controlled, double-blind, double-dummy,~     parallel-group, multicenter study in the United States enrolling patients with active RA. The~     study will enroll approximately 290 patients at approximately 130 sites.~   "
210295|NCT00808197|"~     Age-related macular degeneration (AMD) is the chief cause of severe and irreversible loss of~     vision in developed countries. The prevalence of AMD increases dramatically with age.~      The early stage (or dry AMD) is associated with minimal visual impairment and is~     characterized by large drusen and pigmentary abnormalities in the macula. The late stage is a~     neovascular, exudative form. This so called exudative AMD includes serous or hemorrhagic~     detachment of retinal pigment epithelium and choroidal neovascularization leading to severe~     loss of vision (20/200 or worse). Patients with unilateral CNV (choroidal neovascularisation)~     have a significant risk of CNV developing in the second eye.~      Choroidal blood flow is of great importance for normal visual function. Several reports have~     provided evidence suggesting that choroidal blood flow is decreased in subjects with AMD. In~     late stages of AMD angiogenesis leads to the formation of choroidal neovascularization that~     can cause severe visual impairment by disrupting normal macular function.~      The purpose of this evaluation is to investigate a possible link between alterations in~     choroidal blood flow and the development of CNV and serous detachment in the fellow eye of~     patients with AMD and unilateral neovascular maculopathy. This longitudinal study may provide~     important findings with respect to natural history and visual prognosis of patients with~     neovascularized AMD.~      Ocular blood flow will be determined by non-invasive methods, including laser Doppler~     flowmetry and laser interferometry~   "
210296|NCT00808184|"~     The objectives of this study are:~      To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11)~     and its metabolite SN-38.~      To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan~     and raltegravir pharmacokinetic parameters.~      To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population.~   "
210297|NCT00808171|"~     In this randomised controlled study the investigators intended to compare the analgesic~     effects of EMLA and\or nitrous oxide in children submitted to lumbar puncture.~   "
210301|NCT00808119|"~     This is the first study to be conducted in humans for RTI-336, a new chemical entity, with~     evaluations focusing on the safety, tolerability, and pharmacokinetics of RTI-336 following~     administration of single, oral doses. RTI-336 is a novel dopamine transporter inhibitor of~     the 3-phenyltropane class, and is currently being developed by RTI International as a~     potential pharmacotherapy to treat cocaine dependence. Data from this study will be used to~     plan and define dose ranges for subsequent studies.~   "
210302|NCT00808106|"~     Oculocutaneous albinism (OCA) is a term used to describe inherited forms of hypopigmentation~     associated with 1) variable levels of cutaneous hypopigmentation, ocular hypopigmentation,~     and visual deficits, and 2) involvement of both of the major developmental types of pigmented~     cells, i.e., melanocytes and retinal pigment epithelium. OCA that affects only~     usually-pigmented tissues is termed isolated OCA. There are currently seven albinism types~     (OCA-1 to OCA-7). With the exception of OCA-5, eash is associated with a specific gene and is~     inherited in an autosomal recessive manner OCA-5 is a proposed type of albinism associated~     with the chromosomal location 4q24. OCA-1 results from defects in the enzyme tyrosinase,~     which catalyzes the rate-limiting step in melanin synthesis. The precise functions of the~     remaining genes are not yet fully understood, but several may be associated with the~     regulation of pH in the subcellular organelle where melanin in manufactured-the melanosome.~     The majority of persons with OCA have two pathogenic mutations identified in a known~     OCA-causing gene, but a substantial minority to not. Ocular albinism (OA) is an X-linked~     disorder caused by mutations in the GPR143 gene. It affects the eye in a manner similar to~     OCA, but has minimal or no skin manifestations.~      In this protocol, we have four major goals:~        1. To clinically and comprehensively characterize OCA types 1 - 7, and OA, with respect to~          the degree of hypopigmentation, genetic mutations, extent of ocular involvement, and~          longitudinal variation.~        2. To use study participants cultured melanocytes to study pigment biology, variability in~          pigment formation related to genotype, and response to proposed treatments. Some of this~          work will be performed collaboratively.~        3. To recruit study participants with hypopigmentation not due to known albinismcausing~          genes.~        4. To evaluate methods of quantifying eye pigmentation, skin pigmentation and other~          clinical parameters that may be usable as outcome measures in future treatment studies.~      To achieve those goals, we will perform clinical evaluations of persons with OCA and OA at~     the NIH Clinical Center; obtain cultured cells, plasma, serum and urine for future studies;~     and, perform mutation analysis on known OCA and/or OA genes and search for other genes~     responsible for albinism. Routine admissions will last 3 - 4 days and occur every 2 - 3~     years.~   "
210303|NCT00808093|"~     The purpose of this study is to compare the effects of fasting and fed conditions with repeat~     doses of GSK256073F in HVT subjects.~   "
210304|NCT00808080|"~     The aim of this protocol is to investigate a novel form of immune therapy for patients with~     acute myelogenous leukemia (AML) who are in remission (CR) but who are at high risk for~     relapse.~   "
210305|NCT00808067|"~     The purposes of this study are:~        1. To evaluate the long-term safety of dabigatran etexilate~        2. To assess the effect of a knowledge translation intervention on patient outcomes~   "
210306|NCT00808054|"~     In this randomized controlled study the investigators intended to compare analgesic effects~     of EMLA and/or oral glucose in 60 preterm neonate during arterial function and PICC~     installation.~   "
210307|NCT00808041|"~     The purpose of this study is to determine if dedicated breast computed tomography can be used~     successfully to monitor tumor response in breast cancer patients undergoing neoadjuvant~     chemotherapy.~   "
210308|NCT00808028|"~     The purpose of this study is to evaluate the safety and immunogenicity of an investigational~     meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.~   "
210309|NCT00808015|"~     The purpose of this study is to describe the characteristics of the smoker who wants to quit~     and his/her treating physician, in addition to determine the safety and effectiveness of~     Champix in the real-world setting of smokers in routine clinical practice.~   "
210310|NCT00808002|"~     The intensification with maraviroc in recently HIV-1-infected patients of a preferred~     gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could~     accelerate the decay of the HIV-1 reservoir in latently infected cells established early in~     HIV-1 infection.~      This could provide further insight into this area, decrease the size of latent reservoir, and~     translate into clinical benefits for patients.~   "
210311|NCT00807989|"~     To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and~     Valproate. Low dose combination may be more effective and tolerable because they are low dose~     and VPA reduce Lamotrigine metabolism.~   "
210312|NCT00807976|"~     Rationale: Orthostatic hypotension increases with age and is associated with increased~     vascular and all-cause mortality. The prevalence of orthostatic hypotension is also increased~     in diabetic subjects. In order to prevent related adverse events and vascular mortality it is~     of great interest to examine the prevalence of orthostatic hypotension in elderly diabetic~     subjects.~      Objective: To examine the prevalence of orthostatic hypotension and associated adverse events~     in type 2 diabetic elderly subjects.~      Study design: Cross-sectional observational study.~      Study population: Elderly type 2 diabetic subjects (70 years and older).~   "
210313|NCT00807963|"~     The purpose of this study is to determine the maximum tolerated concentration (MTC) of~     bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate~     without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at~     MTC, and to compare the PK of SC administered bisphosphonate at MTC with optimal dose rHuPH20~     to bisphosphonate alone.~   "
210314|NCT00807950|"~     We hypothesize that Simvastatin administration would result in selective killing of the basal~     subtype of breast cancer, in particular, CD44+/CD24- breast cancer cells in primary tumor. We~     further hypothesize that tumor genomic changes would correlate with tumor response to~     Simvastatin. We are also looking to correlate Simvastatin biological effects with the~     expression pattern of initial status of primary tumor. In addition, we hypothesize that~     Simvastatin-induced tumor gene expression changes may correlate with tumor and plasma~     proteomics, peripheral blood mononuclear cell gene expression changes, and pharmacogenetics,~     and that these analyses may further refine the selection of patients most likely to benefit~     from Simvastatin.~   "
210315|NCT00807937|"~     The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe~     and effective in the treatment of generalized anxiety disorder.~   "
210316|NCT00807924|"~     The purpose of this patient tracking program is to monitor long term safety and effectiveness~     of the Novilase™ device and method in real world application.~   "
210317|NCT00807911|"~     The purpose of this study is to evaluate the disease-free survival in patients with locally~     advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and~     surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs~     5-FU/Leucovorin.~   "
216211|NCT00729469|"~     The purpose of this study is to determine the safety and efficacy of ospemifene in~     postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain~     associated with sexual activity.~   "
210318|NCT00807898|"~     Preventing cervical cancer is a public health concern. Since 2006 a quadrivalent vaccine for~     young women nine to twenty six years of age has been available to protect against the human~     papillomavirus (HPV) and to prevent some types of cervical cancer (Gardasil). The vaccine is~     an important health promotion tool to address the widespread prevalence of HPV and cervical~     cancer, but not all eligible young women receive the vaccine. The vaccine is most effective~     when administered to young women before their sexual debut. When the vaccine is given to~     young women less than 18 years of age, parental permission is required. This permission is~     usually provided by the young woman's mother. Understanding predictors of a mother's decision~     for her minor daughter to receive the HPV vaccine will inform interventions that seek to~     increase the number of young women who receive the vaccine.~      The study will focus on mothers and their adolescent daughters between 13-17 years of age. We~     hypothesize that the Expanded Theory of Planned Behavior will explain a mother's decision to~     choose the HPV vaccine for her daughter.~      Research Questions include: 1)What TPB variables predict a mother's decision to choose HPV~     vaccine for her daughter? 2)What variables predict the strength of a daughter's influence on~     the mother's decision to choose HPV vaccine for her daughter? 3) What are the relationships~     between the mothers' and daughters' scores on the variables related to the decision to choose~     HPV vaccine? 4) How do the mothers and daughters who chose to receive the HPV vaccine differ~     descriptively from those mothers and daughters who do not choose to receive the HPV vaccine?~   "
210319|NCT00807885|"~     The purpose is to evaluate the ease of use and technical challenges encountered during~     subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human~     hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery~     systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these~     delivery systems is also being evaluated.~   "
210320|NCT00807872|"~     The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive~     monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT~     imaging in patients with AL amyloidosis.~   "
210321|NCT00807859|"~     The purpose of this study is to determine if AMG 386 in combination with either paclitaxel~     and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with~     HER2-positive locally recurrent or metastatic breast cancer.~      This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation~     study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab~     (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of~     the tolerable doses determined in part 1.~   "
210322|NCT00807846|"~     This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib~     (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic~     Arthritis~   "
210323|NCT00807833|"~     It is a proof of concept study, aimed to evaluate whether the optimal CPP, defined by the~     best PRx, corresponds to the acceptable CBF values in patients affected by CBF disfunction~     caused by TBI or SAH.~   "
210324|NCT00807820|"~     This is a phase I study to evaluate the feasibility and safety of using MRI/MRS to identify~     the dominant intraprostatic lesion (DIL) and to selectively boost the lesion using inverse~     planned high dose rate (HDR) brachytherapy.~      The main objective is to exploit the ability of MRI/MRS to identify cancer regions within the~     prostate or the dominant intraprostatic lesions (DIL). The imaging data will be combined with~     the treatment planning CT images to define a treatment plan that will boost the dose~     delivered to the DIL up to 150% of the prescribed dose. Dose to the whole prostate and the~     dose delivered to adjacent organs will not change. This is accomplished by using inverse~     treatment planning software that can focus normally occurring high dose regions within the~     target volume to coincide with the DIL.~      After enrollment, each patient will have a MRI/MRS before starting treatment. Hormonal~     therapy and external beam radiotherapy will be given based on current standard of practice.~     During HDR brachytherapy, information about the location of tumor within the prostate will be~     used to design the brachytherapy treatment plan. We will try to increase dose to DIL by~     coincide existing high dose region on DIL using inverse planning software. Dose to prostate,~     and adjacent structure will remain the same as the current treatment practice. Timing and the~     delivery of brachytherapy will not change from our current practice. After the treatment,~     each patient will remain on study and follow for 12 months and treatment toxicity will be~     evaluated. A two-stage study design will be applied with a stopping rule for safety. Once a~     patient comes off study he will be routinely followed for disease outcome and any late~     toxicities.~   "
210325|NCT00807807|"~     High levels of homocysteine, which is an amino acid in the blood, have been linked to an~     increased risk of heart disease. This study will examine the effect that differing levels of~     folic acid have on reducing homocysteine levels among older adults.~   "
210326|NCT00807794|"~     To evaluate the clinical safety of different doses of MEDI-507 through day 33.~   "
210327|NCT00807781|"~     The purpose of this study is to evaluate the safety of mammaglobin-A DNA vaccine in~     metastatic breast cancer patients.~   "
210328|NCT00807768|"~     This randomized phase III trial studies pelvic radiation therapy to see how well it works~     compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating~     patients with high-risk stage I or stage II endometrial cancer. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material~     placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as~     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It~     is not yet known whether pelvic radiation therapy alone is more effective than vaginal~     implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial~     cancer.~   "
210329|NCT00807755|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as carboplatin and etoposide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) together with everolimus may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus,~     carboplatin, and etoposide in treating patients with small cell lung cancer or other advanced~     solid tumors.~   "
210331|NCT00807729|"~     Objective: We compared outcome parameters for good-risk patients with classic signs,~     symptoms, laboratory and abdominal imaging features of cholecystolithiasis and~     choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC.~      Design: Our study was a prospective trial conducted following written informed consent with~     randomization by the serially-numbered opaque envelope technique.~      Setting: Our institution is an academic teaching hospital and the central receiving and~     trauma center for the City and County of San Francisco.~      Patients: We randomized 122 patients (American Society of Anesthesiologists Grade I or II)~     meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol~     violators having signed out of the hospital against medical advice before one of both~     procedures were completed.~      Interventions: Treatment was pre-operative endoscopic retrograde cholangiopancreatography~     sphincterotomy (ERCP/S) followed by laparoscopic cholecystectomy (LC), or laparoscopic~     cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE).~      Main Outcome Measures: The primary outcome measure was efficacy of stone clearance from the~     common bile duct. Secondary endpoints were length of hospital stay, cost of index~     hospitalization, professional fees, hospital charges, morbidity and mortality, and patient~     acceptance and quality of life scores.~   "
210332|NCT00807716|"~     Physiotherapy plays an important part in rehabilitation after total knee arthroplasty. Even~     if this is a common practice, few studies have been performed on this issue.~      The prime aim of this study is to examine the effects of an ambulatory individualized~     task-oriented exercise program compared with current ambulatory physiotherapy(usual care)on~     activity performance and self efficacy beliefs in the time span 6 weeks to 3 months after~     total knee arthroplasty with a follow-up at twelve months.~      HO:Task oriented physiotherapy has better effect than usual care on activity performance and~     self-efficacy beliefs in the time span 6 weeks to 3 months after total knee replacement.~   "
210333|NCT00807703|"~     In the advanced stages of Parkinson Disease deep brain stimulation of the subthalamic nucleus~     (STN DBS) is the next therapeutic option. Despite the beneficial motor effects there are~     important negative side-effects of STN DBS. Our hypothesis is that changes in cognition and~     behavior during STN DBS are related to stimulation of the non-motor parts of the STN.~      The primary objective is to avoid cognitive and affective side effects by selective~     stimulation of the STN motor part.~      The main objective of this feasibility study is to measure the patients burden and to test~     the technical feasibility.~      Intervention:~      The intervention is an expansion of the classical STN DBS procedure. The targeting using the~     multichannel registration system by stimulation of the motor cortex and registration of the~     subthalamic nucleus will be added to the procedure. For this procedure, it is necessary to~     place a subdural strip under the skull.~   "
210334|NCT00807690|"~     BACKGROUND Vitiligo is a common, often distressing condition. Many of the patients do not~     achieve sufficient effect from what is regarded as the treatment of choice at present, narrow~     band(NB)UVB(Tl01). There are reports on some patients partly successfully treated with~     Tacrolimus ointment.~      AIM OF THE STUDY We want to study whether Tacrolimus ointment may give an additive effect on~     symmetric vitiligo in combination with NB-UVB.~      METHODS This is a double blind left/right comparative study with 6 months treatment time.~     Patients are treated with whole body NB-UVB x 2 or x 3 weekly, in addition to Tacrolimus~     ointment versus placebo every night on affected half body sites. To measure effects we use~     photodocumentation in addition to morphometric registration of symmetric target lesions every~     6 weeks.~   "
210335|NCT00807677|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of TAK-901 in~     subjects with advanced hematological malignancies, and to further assess the safety and~     tolerability of TAK-901 at or below the MTD in an expanded cohort of subjects in order to~     select a dose for future studies.~   "
210336|NCT00807664|"~     the objective of this investigation is to demonstrate the effect of the foam dressing Biatain~     Ag, compared to Biatain foam dressing( a product which is similar but does not contain a~     silver complex, in the healing of leg ulcers that had failed to heal despite appropriate~     therapy~   "
210337|NCT00807651|"~     This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within~     the previous 6 months. The study is evaluating whether stem cell transplantation is safe when~     chemotherapy and immunotherapy are used in combination and if it has immune resetting effect~     that may halt the immune attack to pancreas islets and thus preserve the body's own insulin~     production.~   "
210338|NCT00807625|"~     In this study, 66 HIV-infected women who desire contraception will be randomly assigned to~     use either an IUD or Depo Provera, and will be followed for six months. The study is intended~     to help investigators understand potential mechanisms by which hormonal contraception may~     hasten HIV disease progression.~   "
210339|NCT00807612|"~     This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study~     designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and~     carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.~   "
210340|NCT00807599|"~     The purpose of this study is to compare the effects, good and bad, of two ways to treat~     patients with standard-risk symptomatic multiple myeloma. Patients with standard-risk myeloma~     have myeloma with specific features: levels of 2 blood tests have to be in a specific range~     and there can be no myeloma tumors found outside of the bones or bone marrow, the areas where~     myeloma is usually discovered. In past clinical studies, patients with standard-risk myeloma~     have done well with intensive therapy in the form of stem cell transplant. But multiple~     myeloma is not curable and, although it may respond to standard treatments including stem~     cell transplant, myeloma always recurs.~   "
210341|NCT00807586|"~     Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20%~     of the time the atrial fibrillation recurs. Steroids given after the ablation may decrease~     inflammation caused by the ablation and thus improve healing and decrease the chance of~     recurrence of atrial fibrillation.~      In this study patients will be randomized to receive intravenous steroids or not immediately~     following the ablation.~   "
210354|NCT00807404|"~     RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective~     in finding tumor cells.~      PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from~     women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial~     neoplasia.~   "
210342|NCT00807573|"~     The purpose of this study is to determine the percentage of patients with non-small cell lung~     cancer that will experience a shrinkage of their tumors following treatment with three~     medications given together: paclitaxel, pemetrexed (Alimta®), and bevacizumab (Avastin®).~     Each of these medications has been approved by the FDA for patients that have not received~     any treatment for their lung cancer. This study is designed to study the effects of all three~     drugs given at the same time.~      Each of these medications has been studied in lung cancer and is commercially available.~     Paclitaxel and pemetrexed are traditional chemotherapy drugs. Bevacizumab is a monoclonal~     antibody, which means that it attaches to a specific target. Bevacizumab attaches to a~     protein in the blood stream called Vascular Endothelial GrowthFactor (VEGF). VEGF helps~     tumors grow new blood vessels to feed themselves, and bevacizumab is thought to help block~     this new growth of blood vessels and starve the tumors of the nutrients they need.~   "
210343|NCT00807560|"~     The purpose of this study is to determine whether a parent/guardian intervention for~     adolescent overweight/obesity more effective than a nutritional counseling education~     curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.~   "
210344|NCT00807547|"~     Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing~   "
210345|NCT00807534|"~     This study was designed to test the following hypothesis:~      The 3-min constant rate step test and the 3-min constant rate shuttle walk test will be~     sensitive to detect improvement in exertional dyspnea following acute bronchodilation in~     patients with COPD.~   "
210346|NCT00807521|"~     The stress response as induced by myocardial cellular damage during cardiac surgery may lead~     to myocardial stunning and apoptosis, and could therefore impair postoperative patient~     recovery. Surgical trauma typically induces the liberation of cytokines. Some of these~     cytokines are strongly associated with the initiation of intracellular proapoptotic pathways~     through activation of tyrosine kinases and integrins. The latter are known for their~     deteriorating effects on cardiac function and are strongly involved in cardiac remodeling.~     Dexamethasone is typically administered prior to cardiac surgery in order to especially~     reduce the release of proinflammatory cytokines. It has however never been investigated~     whether this additionally reduces proapoptotic signaling in the human heart, thereby~     eliminating risk factors for the induction of cardiac dysfunction. In the present study, the~     investigators therefore aim to investigate whether dexamethasone inhibits proapoptotic~     pathways in patients undergoing cardiac surgery. Furthermore, the investigators would like to~     elucidate whether this proposed effect of dexamethasone is related to the reduction of the~     stress response in the heart or indirectly by suppression of cytokine release. For this~     purpose the investigators will obtain cardiac biopsies and plasma from patients, who are~     randomly assigned to placebo or dexamethasone treatment and undergo on and off-pump coronary~     artery bypass grafting (CABG) surgery.~   "
210347|NCT00807508|"~     In the present study the investigators aim to determine whether leucine supplementation can~     augment muscle mass and strength and improve body composition in healthy elderly men~   "
210348|NCT00807495|"~     The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in~     participants with relapsed or refractory non-hodgkin's lymphoma.~   "
210349|NCT00807482|"~     The overall short-term goals of this project include the following: 1) identify the genes~     that are key to the function of respiratory cilia to protect the normal lung; and 2) the~     effects of genetic mutations that adversely affect ciliary function and cause primary ciliary~     dyskinesia (PCD), which results in life-shortening lung disease. The long-term goal of this~     project is to develop better understanding of the underlying genetic variability that~     adversely modifies ciliary function, and predisposes to common airway diseases, such as~     asthma and chronic obstructive pulmonary disease.~   "
210350|NCT00807469|"~     COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only~     disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is~     obscure, therefore more insight is needed to design effective anti-inflammatory agents. We~     hypothesize that healthy individuals who are susceptible to smoking demonstrate a higher and~     aberrant inflammatory response to cigarette smoke. This susceptibility is caused by~     heterogeneous factors and is associated with various polymorphic genes that interact with~     each other and with the environment.~      Objective:~        -  To define mediators involved in the early induction of COPD in susceptible smokers (and~          so to define new drug targets)~        -  To develop new biological and clinical markers for the early diagnosis and monitoring of~          COPD~        -  To compare between susceptible and non-susceptible individuals the corticosteroid~          responsiveness of bronchial epithelial cells in vitro, and to study the mechanisms of~          smoking-induced corticosteroid unresponsiveness.~        -  To study the role of candidate genes that may play a role in the development of fixed~          airway obstruction, and to identify clues for patient's responsiveness to specific~          drugs.~   "
210351|NCT00807456|"~     The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA~     TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is~     sloped in a lingual to buccal direction.~      The hypothesis is that the sloped marginal contour of the implant will help preserve the~     lingual/palatinal marginal bone.~   "
210352|NCT00807443|"~     The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with~     a viral load below 50 copies/mL is the main limitation to eradication of the virus from the~     body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore,~     patients are obliged to continue with treatment for a period calculated to be greater than 60~     years.~      Despite the important advances in knowledge of the biology of this reservoir, we still have~     no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the~     first time with an integrase inhibitor is exceptional, since the results could provide~     important information on the nature of this reservoir.~      If maintenance of the reservoir is a dynamic process, inclusion of an integrase inhibitor is~     expected to lead to a reduction in the size of this reservoir. This effect could be critical~     when including IAT (viral reactivation), since, in theory, it would be necessary to act on a~     smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of~     the viral reservoir (approximately 1,000,000 cells).~      The study has also been designed to enable us to understand the biochemical and molecular~     mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step~     to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.~   "
210356|NCT00807378|"~     This study of neurotropic viral infection and Tuberculous CNS infection is the comprehensive~     investigation of CSF PCR arrays (Hybrydiaztion technique,Sybergreen and Taqman real time PCR~     arrays of CSF ) in suspected cases of viral CNS infection, Tuberculous CNS infection in both~     AIDS and non AIDS patients.~      Patients with clinical viral encephalitis and all meningoencephalitis including all patients~     with HIV/AIDS CSF and non AIDS will be banked and test for RNA and DNA viral sequence by Real~     time PCR arrays and IS6110 gene of Mycobacterium tuberculosis. Clinical data and final~     diagnosis will be used to analyze the result of this PCR arrays technique compared to~     clinical gold standard criteria.~   "
210357|NCT00807365|"~     The purpose of the study is to evaluate the effect of a naturally occurring hormone, called~     Growth Hormone Releasing Hormone (GHRH), on the muscle, bone and fat tissues of the body.~     GHRH stimulates the production of growth hormone (GH), which regulates the build up of many~     tissues in the body, including muscles and bones. Many elderly people have low levels of GH.~     The overall goal of this research is to determine the effectiveness of GHRH to raise levels~     of GH and improve these body tissues. The purpose of the tests is to measure how the body~     handles sugar, fat, and proteins. GH can affect your body's use of sugar, fat and proteins.~   "
210358|NCT00807352|"~     The aim of this study is to evaluate the validity and the reproducibility of the canadian~     triage and acuity scale when applied by regular nurses for the triage of children in the~     Emergency Department.~   "
210359|NCT00807339|"~     This is a dose escalation study using the CyberKnife radiotherapy device for small surgical~     or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter~     will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and~     maintain renal function with dose escalation will be assessed.~   "
210360|NCT00807326|"~     A comparison of three medications to treat diarrhea in adults.~   "
210361|NCT00807313|"~     Patients with oligometastatic colorectal cancer (5 metastases or less) receive a combination~     of systemic treatment and often local treatment, such as surgery, radiofrequency ablation and~     more recently stereotactic body radiotherapy. The aim of this study is to register the~     results and side effects of stereotactic body radiotherapy (SBRT) by means of helical~     tomotherapy in the treatment of oligometastatic colorectal cancer.~      The trial has two cohorts. Patients in cohort I get consolidation SBRT after best response on~     first line chemotherapy. Patients in cohort II get SBRT when there is progression under, or~     no indication for (further) chemotherapy. The primary endpoint is to evaluate the metabolic~     complete remission rate three months after the start of radiotherapy.~   "
210362|NCT00807300|"~     Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the~     treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or~     proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is~     radiosensitive to certain protocols. In Phase I and II studies, the investigators~     investigated the potential role of local irradiation in primary and secondary liver tumors~     employing a Iridium192 source. The promising results of previous studies indicate that~     CT-guided brachytherapy might play a role in the treatment of unresectable HCC.~      Therefore, the investigators started a randomized, controlled, clinical Phase-II study to~     evaluate the efficacy and survival-benefits of brachytherapy versus transarterial~     chemoembolization in patients with unresectable HCC.~   "
210363|NCT00807287|"~     In patients with high gastric residual volumes jejunal feeding is recommended. Jejunal~     feeding tubes can be placed in different ways. The endoscopic technique yields a success rate~     between 90 and 98% for a correct jejunal placement. However, it requires endoscopic equipment~     and trained staff. In contrast in small uncontrolled trials different unguided techniques~     resulted in success rates up to 75%, only. In this prospective randomized trial the success~     rate of a correct jejunal placement with the endoscopic technique is compared with the~     unguided frictional technique. The investigators hypothesize that the success rate of the~     unguided frictional placement method will be lower than the success rate of the endoscopic~     method.~   "
210364|NCT00807274|"~     Impaired kidney function is associated with a poor outcome in patients with heart failure but~     it is not known of this is the case for patients who have been born with their heart~     condition (congenital heart disease). This study aims to investigate how frequently patients~     with congenital heart disease have kidney disease and whither this does have an impact on~     their outcome. The hypothesis is that kidney dysfunction will be common in these patients and~     may have an impact on long-term health and life-expectancy.~   "
210365|NCT00807261|"~     To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft~     tissue sarcoma previously treated with anthracycline and/or ifosfamide~        1. Primary endpoint: response rate~        2. Secondary endpoint: progress-free survival, overall survival, safety~   "
210366|NCT00807248|"~     To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses~     of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of~     treatment in patients with Major Depressive Disorder~   "
210367|NCT00807235|"~     To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by~     nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress~     syndrome (RDS) in premature infants.~   "
210368|NCT00807222|"~     This study involves research to test how Vyvanse (study drug) affects sleep in 24 children~     aged 6 to 12 years who have ADHD. Vyvanse is approved by the FDA for the treatment ADHD of in~     children aged 6 to 12 years. The experimental part of this study is to determine how Vyvanse~     affects sleep.~   "
210369|NCT00807209|"~     To review safety and effectiveness of two doses compared to current standard of care.~   "
210370|NCT00807196|"~     The purpose of this study is to investigate the ability to combine a radioactive medication~     directly targeted against lymphoma cells with the immune effects of an allogeneic blood stem~     cell transplant.~   "
210383|NCT00807027|"~     This clinical study was planned in order to assess the superiority of INNOCELL Corp.~     Immuncell-LC in aspects of therapeutic efficacy and safety when administered with~     Temozolomide to glioblastoma patients when compared with the control group who did not~     receive administration of the drug.~   "
210616|NCT00803894|"~     The purpose of this study is to determine the transcriptional signature of Notch Inhibition~     by testing hair and blood samples on healthy male volunteers who have received MK0752 vs~     placebo for possible future biomarkers in the treatment of cancer or Alzheimers Disease~   "
210371|NCT00807183|"~     Although particulate matter (PM) exposures have been linked with poor respiratory health~     outcomes, most of these studies have focused on airsheds with urban and industrial sources of~     PM2.5. Woodsmoke-derived PM also contributes to ambient PM in these urban areas, and is the~     major source of PM in many US rural or peri-urban areas, as well as in many communities~     within developing countries. This study will focus on indoor air quality and clinically~     relevant changes in health effects among asthmatics living in homes whose primary heating~     sources are non EPA-certified woodstoves. The Primary Aim of this study is to assess the~     efficacy of residential interventions to reduce indoor PM exposure from woodstoves and the~     corresponding improvements in quality of life and health outcomes for asthmatic children. The~     study area for this project will be three rural communities in western Montana and Idaho,~     including one Indian Reservation. This study will use a three arm (Tx1, Tx2, and Tx3)~     randomized placebo-controlled intervention trial. The interventions will be at the household~     level, and exposure and outcomes will be assessed for one asthmatic child in each household.~     Households in Tx1 will receive inactive high efficiency particulate air (HEPA) devices and~     will serve as the placebo group. Households in Tx2 will receive a new EPA-certified~     woodstove, while households in Tx3 will receive active HEPA devices. The Secondary Aims of~     this study are to assess the impact of these interventions on residential PM2.5 exposures and~     other health outcomes. Secondary exposure outcomes measured prior to and following the~     intervention will include PM2.5 mass, chemical woodsmoke markers on PM2.5 filters (including~     levoglucosan and abietic acids), and biomarkers of woodsmoke exposure. Secondary~     asthma-related health outcomes measured prior to and following the intervention will include~     peak expiratory flow (PEF) and forced expiratory volume in first second (FEV1), biomarkers in~     exhaled breath condensate, and frequency of asthma symptoms, medication usage, and healthcare~     utilization. To our knowledge, this will be the first randomized trial in the US to utilize a~     woodsmoke intervention to assess the impact of the consequent reductions in indoor PM on~     health outcomes in a susceptible population. The results from this project will be~     translatable to other regions in the US and the world where biomass burning is commonly used~     for heating and cooking.~   "
210372|NCT00807170|"~     A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT~     in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of~     3 Gy. Patients will start 7 days prior to start of radiation treatment with Vandetanib. Total~     treatment time with Vandetanib is 3 weeks (21 days). Patients will have the opportunity to~     continue Vandetanib until progression at a dose of 300 mg. This multi-centre study will be~     conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.~   "
210373|NCT00807157|"~     The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of~     people sensible to daily stress.~   "
210374|NCT00807144|"~     The current anti−rejection drug regime for kidney transplant recipients in use at the West~     London Renal & Transplant Centre (WLRaTC) consists of induction therapy with the very potent~     monoclonal antibody Campath 1−H (Alemtuzumab) followed by long−term maintenance with the~     Calcineurin inhibitor Tacrolimus~      The recent development (and licensing in the UK) of an extended−release, once daily~     formulation of Tacrolimus holds out the promise of simpler drug regimes for our patients. In~     the context of our current successful use of Tacrolimus monotherapy maintenance after Campath~     1−H induction, the extended−release Tacrolimus formulation will enable us to offer a regime~     where the only long−term immunosuppressive treatment that most of our patients need will be a~     single drug, taken once a day.~      The investigators wish to assess the efficacy of such a regime in a structured comparison~     with our current protocol.~   "
210375|NCT00807131|"~     This randomized clinical trial is a multicentre study conducted at 4 community-based~     pharmacies within the Brazilian public health service, which freely distributes standardized~     medicines. The group coordinator is located at the Universidade Federal do Rio Grande do Sul,~     a public university at Porto Alegre.~   "
210376|NCT00807118|"~     Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial~     formulation in both under fasted and fed condition, and bioequivalence between formulation~     E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective~     is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set~     to get data for Japanese regulatory submission.~   "
210377|NCT00807105|"~     This is a prospective open label study of acute and maintenance treatment of MDD. The acute~     phase consists of daily treatments for 4 weeks. maintenance will be twice a week for eight~     weeks followed by 10 weeks of once a week treatments.~   "
210378|NCT00807092|"~     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood~     sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to~     biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive~     subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.~   "
210379|NCT00807079|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when~     given together with carboplatin and to see how well they work in treating patients with~     relapsed or metastatic cervical cancer.~   "
210380|NCT00807066|"~     Patients with locally advanced (IIIB with effusion) or metastatic non-small cell lung cancer~     (NSCLC), EGFR FISH positive, candidate for a first-line platinum-based chemotherapy will be~     considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and~     after signature of informed consent form, all eligible patients will be randomized to receive~     standard chemotherapy (control arm) or gefitinib (250 mg daily dose-experimental arm).~     Before, and in every case, no more than 4 weeks before study entry, all eligible patients~     will receive a complete disease staging, including thoracic and abdominal CT-scan, and blood~     sampling. Bronchoscopy will be done if not previously performed. Bone scan and brain CT-scan~     will be performed only if clinically indicated. Disease assessment will be performed every 6~     weeks (every 2 cycles) for the first 6 cycles, and thereafter every 3 months, with a~     confirmatory evaluation in all patients with response or disease stabilization no less than 4~     weeks after the response assessment, according to RECIST Criteria. A complete disease~     staging, including the above mentioned procedures, will be performed in case of progressive~     disease, and, in every cases, when patient withdrawals the trial. Following completion of~     protocol therapy, patients will be followed every 3 months.~   "
210381|NCT00807053|"~     The primary objective of this study is to demonstrate the efficacy of ciclesonide HFA,~     applied as a nasal aerosol once daily, in patients with SAR. The secondary objectives are to~     evaluate Quality-of-Life and safety.~   "
210382|NCT00807040|"~     People with coronary artery disease (CAD) or people who have had a heart attack may develop a~     leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the~     valve. The best way to fix the mitral valve remains undetermined. This study will evaluate~     whether it is better for people with severe mitral valve leakage to undergo a mitral valve~     replacement procedure or a mitral valve repair procedure.~   "
210384|NCT00807014|"~     The objectives of this clinical trial are to compare the quality of life of the subjects, the~     efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin~     phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily,~     against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to~     moderate acne vulgaris.~   "
210385|NCT00807001|"~     This is a proof-of-concept study which will provide data about the safety and antiviral~     activity of several doses of the investigational drug IDX184 given for 3 days in~     treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for~     testing in later studies.~   "
210386|NCT00806988|"~     Coronary artery bypass grafting (CABG) is a procedure that people with coronary artery~     disease (CAD) may undergo to increase blood flow to the heart. During a CABG procedure,~     people who have a leak in one of the valves in the heart—the mitral valve—may at the same~     time undergo a procedure that repairs the valve. This study will evaluate whether people with~     moderate mitral valve leakage would be better off undergoing CABG plus the mitral valve~     repair procedure or undergoing CABG alone.~   "
210387|NCT00806975|"~     The purpose of this study is to investigate patient's usability, preference and blood glucose~     control for the new prefilled disposable insulin lispro mixture (Humalog Mix 25 injection~     KwikPen®). For that purpose, randomized open-label, 2-period direct comparative crossover~     study is planned in comparison with insulin aspart mixture (Novo Rapid 30 Mix injection~     FlexPen®).~   "
210388|NCT00806962|"~     Randomized, double blind, multi-site, study in healthy adults, comparing safety and~     immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with~     placebo controls~      Primary Objective:~        -  Safety as determined by occurrence of local intranasal symptoms or other symptoms as~          reported by a self-administered memory aid for 7 days after each vaccination and~          hematology, blood chemistry and physical examinations performed by the clinical research~          staff~        -  Subjects will also be monitored for Serious Adverse Events (SAEs), and onset of any new~          medical conditions for 180 days following the last study vaccinations (Day 201).~      Secondary Objectives~      Evaluations of immunogenicity as determined by:~        -  Geometric mean titers and seroconversion rate of serum anti- Norwalk VLP IgG and IgA~        -  Stimulation of anti-Norwalk VLP IgA antibody secreting cells (ASC)~        -  Presence of antigen specific memory B-cell response~      Cells will be collected and stored for possible future evaluation of Norwalk VLP-specific~     cell-mediated immune (CMI) responses~      Study Hypothesis:~      The incidence of adverse events after intranasal Norwalk VLP Vaccine will be the same as the~     incidence of adverse events after intranasal adjuvant/excipients alone. Norwalk VLP Vaccine~     and adjuvant/excipients will have a higher incidence of mild to moderate nasal adverse events~     compared to placebo but similar incidence of other adverse events.~      Two doses of the 100 µg of Norwalk VLP Vaccine will be more immunogenic than two doses of 50~     µg of Norwalk VLP Vaccine. The post-vaccination serum antibody responses, the number of~     antibody secreting cells (ASC) and IgG and IgA memory B-cell responses directed against~     Norwalk Virus antigen will be increased after Norwalk VLP Vaccine compared to~     adjuvant/excipients and to placebo.~   "
210389|NCT00806936|"~     This study is conducted in Asia. The aim of this observational study is to investigate the~     percentage of patients reaching the treatment target on blood glucose control after treatment~     with either human insulin or insulin analogues in type 2 diabetes subjects inadequately~     controlled with two or more oral antidiabetic drugs in China. Further the safety profiles~     will be evaluated.~   "
210390|NCT00806923|"~     This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a~     standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous~     non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated~     time of study treatment is until disease progression, and the target sample size is 500+~     individuals.~   "
210391|NCT00806910|"~     Heart Failure is a growing and challenging public health concern in the United States. Heart~     failure commonly manifests as a syndrome of salt and water retention. Arginine vasopressin is~     a peptide hormone that is intimately involved in salt and water homeostasis. AVP is released~     into the circulation in response low blood volume and hypernatraemia. Despite fluid overload,~     vasopressin levels are often inappropriately elevated in patients with heart failure and LV~     dysfunction. Data suggest that vasopressin may also contribute to the deleterious circulatory~     response in patients with heart failure and play a role in the development and progression of~     the disease process. In their study, Udelson et al. showed that vasopressin receptor~     antagonism with Conivaptan resulted in significant diuresis with stable hemodynamics in~     advanced heart failure patients. Currently Intravenous diuretics and vasodilators are the~     standard of care in treating patients with acute decompensated heart failure. We will be~     studying the renal and diuretic effects of add on therapy with intravenous Conivaptan in~     patients receiving intravenous Nesiritide and intravenous diuretics.~   "
210392|NCT00806897|"~     This study is conducted in Europe. The aim of this observational study is to gain practical~     experience with once daily Levemir® administration in type 2 diabetes patients who were~     previously treated with NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT~     under normal clinical practice conditions in Lithuania~   "
210393|NCT00806884|"~     Hypothesis: The addition of a series of musculoskeletal techniques to normal optimal care for~     the treatment of a respiratory exacerbation in inpatient adults with cystic fibrosis, will~     lead to further improvements in pain, posture, sputum clearance, lung function and quality of~     life.~   "
210394|NCT00806871|"~     The aim of this study is to assess the efficacy of injecting steroid into the carpal tunnel~     in relieving symptoms of carpal tunnel syndrome for at least 1 year with outcomes measured~     with patient evaluated symptoms score.Out of the patients referred by primary care, those~     with a clinical diagnosis of CTS who have tried wrist splint and whose symptom severity is~     judged by the examining surgeon to warrant surgery are offered to be put on the waiting list~     for carpal tunnel release. This means a waiting time of approximately 3 months. Patients who~     give informed consent will be asked to attend the outpatient clinic for a physical~     examination followed by allocation to one of the three trial groups. Immediately following~     the allocation the patients will receive the assigned treatment.~   "
210395|NCT00806858|"~     This study is conducted in Asia. The aim of this observational study is to evaluate subjects'~     treatment satisfaction and to evaluate subjects' preference of pen device and the incidence~     of clinical technical complains while using NovoPen® 4 under normal clinical practice~     conditions.~   "
210396|NCT00806845|"~     The aim of this study is the assessment B-cell immune responses in HIV-infected individuals.~   "
210428|NCT00806403|"~     The main objective is to compare a fibrinolytic strategy with an interventional strategy~     initiated as early as possible, preferably in the pre-hospital phase, with respect to~     resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In~     Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7~     days after inclusion.~   "
210397|NCT00806832|"~     Cataract surgery is the most prevalent surgical procedure. Since most candidates are elderly~     patients, hypertension is common among these patients. Preoperative anxiety and tension may~     cause elevation of patient's heart rate and blood pressure and thus expose them to serious~     potential complications such as stroke and myocardial infarction. Medical clowns are known to~     reduce preoperative anxiety of both children and their parents. It is possible therefore that~     medical clown may have such a beneficial effect also on patients scheduled for cataract~     surgery under local anesthesia.~   "
210398|NCT00806819|"~     The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed~     therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in~     patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed~     will be obtained.~   "
210399|NCT00806806|"~     Given as a single perioperative injection, SKY0402 could provide adequate, continuous, and~     extended pain relief that could greatly simplify postoperative pain management, reduce the~     need for repeated administration, and minimize episodes of breakthrough pain.~   "
210400|NCT00806780|"~     The purpose of this study is to assess whether routine imaging of the biliary system during~     routine gallbladder surgery alters clinical outcome~   "
210401|NCT00806767|"~     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem~     cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It~     also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune~     response against the body's normal cells. Giving antilymphocyte globulin before transplant~     may stop this from happening.~      PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte~     globulin together with donor stem cell transplant works in treating older patients with~     hematological cancer.~   "
210402|NCT00806754|"~     -  The primary objective of this study is to evaluate the efficacy of the concomitant~          administration of ciclesonide nasal spray and azelastine nasal spray versus ciclesonide~          nasal spray alone in patients (18 years or older) with perennial allergic rhinitis (PAR)~          not adequately controlled on an intranasal corticosteroid or antihistamine monotherapy~        -  The secondary objective is to investigate the safety of the concomitant administration~          of ciclesonide nasal spray and azelastine nasal spray~   "
210403|NCT00806741|"~     Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance~     to changes in perfusion pressure. In the eye, several studies have reported that retinal~     blood flow is autoregulated over a wide range of ocular perfusion pressures. The~     investigators recently showed that nitric oxide (NO) is a key metabolite in the regulation of~     vascular tone in the eye and plays an important role in the blood flow autoregulation of the~     choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the~     present study is designed to test the hypothesis that NO plays also a role in optic nerve~     head blood flow autoregulation. Therefore, subjects will perform squatting to increase~     systemic perfusion pressure during administration of either a nitric oxide synthase inhibitor~     (L-NMMA), an α-receptor agonist (phenylephrine) or placebo. Optic nerve head blood flow will~     be continuously measured during the procedure to investigate optic nerve head autoregulation.~   "
210404|NCT00806728|"~     A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell~     and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.~   "
210405|NCT00806715|"~     The goal of this study is to examine the impact of iron overload in patients undergoing a~     bone marrow transplant. We believe that the iron status in these patients is associated with~     complications for transplant survivors. We will examine the iron status in these patients by~     MRI and by screening for mutations in genes known to cause iron overload. We will also~     determine the levels of hepcidin (a hormone produced in the liver that appears to regulate~     iron homeostasis) from blood and urine.~   "
210406|NCT00806689|"~     24 hour Holter monitoring (24HM) is commonly used to assess cardiac rhythm after surgical~     therapy of atrial fibrillation. This snapshot rhythm documentation leaves a large~     diagnostic window of non recorded atrial arrhythmias and as such a large amount of~     uncertainty in follow-up result assessment. To improve accuracy of rhythm surveillance thus~     gaining a more real-life scenario of post surgical ablation therapy cardiac rhythm a new~     insertable cardiac rhythm monitor device (Reveal® XT 9525, Medtronic Inc., Minneapolis, MN,~     USA) with full observational continuous heart rhythm documentation is implanted.~      In order to verify different follow-up strategies after surgical atrial fibrillation therapy,~     a comparison of different follow-up scenarios (symptoms, different cardiac documentation~     devices i.e. ECG and 24 hour Holter monitor, at different follow-up time points) is performed~     intraindividually. Thus the reliability of these devices and follow-up strategies to define~     success after ablation therapy is evaluated.~   "
210407|NCT00806676|"~     People with chronic kidney disease are known to have immune response abnormalities, including~     a diminished response to some vaccinations. Those with chronic kidney disease have a~     disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to~     immune response abnormalities, the CKD population may or may not respond to the recommended~     three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and~     18-related genital tract disease. The objective of this study is to measure the antibody~     response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD)~     (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant.~     Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples~     to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained~     at months 0, 7 and 24.~   "
210408|NCT00806663|"~     This is an open label single arm prospective multicenter Phase II study in around 20~     patients. The primary objective of this study is to evaluate whether the addition of~     sunitinib to FOLFIRI results in a significant reduction of tumor vessel permeability (TVP)~     and blood flow (BF) measured by DCE-MRI and DCE-USI, measured on liver metastases.~      Secondary objectives are antitumor response, time to progression (TTP), effect on~     pharmacokinetics of sunitinib and biomarkers (VEGF und soluble VEGF-receptor) and~     drug/treatment safety.~   "
229792|NCT00548899|"~     The purpose of this study is to determine the efficacy and safety of sorafenib in the~     neoadjuvant setting in patients with primary breast cancer~   "
210409|NCT00806650|"~     This research trial studies the development of a blood test for detecting anti-insulin-like~     growth factor II mRNA binding protein 3 (anti-IMP3) antibody and micro ribonucleic acid~     (microRNA) in patients with renal cell carcinoma (RCC) that has spread to other parts of the~     body (metastatic) or is limited to the tissue or organ where it began (localized). Anti-IMP3~     is a tumor marker that can be detected in many human cancers, including RCC and is likely to~     be present in the serum (blood) of patients with metastatic or localized RCC. Alterations in~     microRNA expression has also shown to play a critical role in cancer progression and may be a~     promising biomarker for patients with RCC. Developing a blood test for anti-IMP3 antibody and~     microRNA in serum and tissue samples of patients in the laboratory may help doctors find and~     diagnose RCC earlier, find out how far the disease has spread, and plan effective treatment~     for RCC.~   "
210410|NCT00806637|"~     The purpose of this study is to compare vessel sealing system uvulopalatoplasty (VSSU) to the~     traditional uvulopalatal flap (UPF) in the treatment of sleep-disordered breathing with~     special regard to intraoperative bleeding, operative time, postoperative pain, postoperative~     hemorrhage and other adverse effects.~   "
210411|NCT00806624|"~     This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with~     non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient~     basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind~     DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses.~     Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the~     Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary~     endpoints are incidence of major, clinically relevant non-major and minor bleeding events~     (all bleeding).~   "
210412|NCT00806611|"~     Determine if the addition of an intraoperative ethanol celiac plexus neurolysis (alcohol~     block) in patients undergoing surgical intervention for pancreatic cancer will result in a~     decrease in cancer associated pain~   "
210413|NCT00806598|"~     The goal of this clinical research study is to learn if combining the drugs thymoglobulin,~     methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control~     severe aplastic anemia (AA) or hypoplastic myelodysplastic syndrome (MDS). The safety of this~     combination therapy will also be studied.~   "
210414|NCT00806585|"~     The study will assess the efficacy and tolerability of MK0736 in patients with Type 2~     Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting~     Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients~     will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The~     study will also include a 3 week, posttreatment follow-up period.~   "
210415|NCT00806572|"~     This is a phase II study to examine the clinical and immunological effects of humanized FcR~     non-binding anti-CD3 mAb in participants with Type 1 diabetes mellitus (T1DM), and to develop~     this therapy to prevent the immune destruction leading to β cell loss.~   "
210416|NCT00806559|"~     The purpose of this study is to improve the clinical encounter through the design of the~     clinical environment. We will conduct a randomized controlled trial to measure the extent to~     which a newly designed clinical room, compared to a traditional room, affects the~     patient-physician interaction. We will judge this outcome by (a) videotaping encounters; and~     (b) conducting post-visit surveys with patients and an interview with physicians. We will use~     both qualitative and quantitative tools, including a validated and widely used interaction~     coding system on the videotapes, to draw inferences from these data.~   "
210417|NCT00806546|"~     This study will use an open-label design to evaluate the safety of NP101. Adult subjects who~     meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic~     transdermal patch) for acute migraine attacks over a 12 month period.~   "
210418|NCT00806533|"~     This observational (non-interventional) post-authorization safety study (PASS) will~     investigate the application of Venofundin 6% and of Tetraspan 6% in children with special~     regard to drug safety.~   "
210419|NCT00806520|"~     Obtain Continuous Glucose Monitoring (CGM) data from individuals taking exenatide LAR,~     sitagliptin, or pioglitazone. The CGM measurements collected will help determine the~     characteristics of glucose control prior to treatment and during treatment.~   "
210420|NCT00806507|"~     The goal of this clinical research study is to learn whether different ways of viewing~     echocardiogram pictures along with blood tests can help to see heart-related side effects of~     chemotherapy and trastuzumab earlier than the usual tests.~   "
210421|NCT00806494|"~     To explore the effects of fesoterodine when used in a flexible dose manner~   "
210422|NCT00806481|"~     The purpose of this study is to determine whether lowering phosphate in patients with early~     chronic kidney disease with the phosphate binder sevelamer has beneficial effects on~     cardiovascular structure and function.~   "
210423|NCT00806468|"~     This study will be conducted to study the effect of Desmopressin on the nocturnal micturition~     frequency in patients with idiopathic Parkinson syndrome.~   "
210424|NCT00806455|"~     Exercise is an important clinical feature in cystic fibrosis. Better exercise capacity has~     been associated with better patient outcomes and quality of life. Exercise-induced~     bronchospasm is a condition, often associated with asthma, which may make exercise difficult.~     The role that exercise-induced bronchospasm has in people with cystic fibrosis is unknown.~     This study is designed to determine how often exercise-induced bronchospasm occurs in cystic~     fibrosis.~   "
210425|NCT00806442|"~     The aim of this trial is to determine the efficacy of a combination of two botanicals oils,~     borage seed oil and echium seed oil, as a potential treatment for bronchial asthma.~   "
210426|NCT00806429|"~     The purpose of this study is to determine the feasibility and safety of transvaginal~     appendectomy and determine and compare the postoperative pain and quality of life after~     surgery to standard laparoscopic transabdominal appendectomy.~   "
210427|NCT00806416|"~     This study will evaluate the bioequivalence of alendronate in combination with vitamin D~     (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in~     combination with alendronate compared to vitamin D alone.~   "
210455|NCT00806039|"~     The purpose of this study is to determine whether renal team involvement early at the onset~     of kidney injury will prevent further developement of more severe renal failure and worse~     hospitalization outcomes.~   "
210429|NCT00806390|"~     The primary objective of this study is to investigate whether giving prophylactic metoprolol~     prior to and during anthracycline or trastuzumab therapy will decrease the incidence of~     anthracycline-induced cardiomyopathy. Patients are randomized to receive metoprolol or no~     treatment prior to anthracycline or trastuzumab treatment. The ejection fraction, as measured~     by nuclear ventriculography is measured before and after treatment.~   "
210430|NCT00806377|"~     The purpose of this study is:~        -  To document the incidence of electromagnetic oversensing of ICDs during non-thoracic~          surgery.~        -  To identify any non-thoracic procedure with a higher incidence of generating~          electromagnetic oversensing.~        -  To document the ability of dual chamber ICDs to discriminate electromagnetic~          oversensing.~   "
210431|NCT00806364|"~     This protocol is designed to provide blood, buccal mucosa and bone marrow aspirate samples~     from approximately 250, healthy volunteer donors for use in in vitro studies of mast cells,~     mastocytosis, and allergic diseases. Non-atopic donors will be recruited to donate blood,~     bone marrow, and/or buccal mucosa samples using conventional techniques. The investigational~     nature of the studies in which their blood, bone marrow and buccal mucosa samples will be~     used, as well as the risks and benefits of the donation process will be explained to all~     donors, and a signed informed consent document will be obtained. Donors will be compensated~     according to an established schedule based on the duration and discomfort of the donations.~     Samples provided through this protocol will be used solely for in vitro research. Blood, bone~     marrow, and buccal mucosa samples will be assigned a unique product number and the study~     investigators listed on this protocol will serve as the custodians of the code that links the~     product with a donor s identity. The nature of the in vitro studies in which the blood~     collected in this study will be used is not the subject of this protocol and will be~     described in general terms only. The samples will be used in several Institutional Review~     Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is~     designed to assure adequate and complete informed consent, counseling, and protection of the~     study subjects according to IRB, Office of Human Subjects Research (OHSR), Office for Human~     Research Protections (OHRP) and other applicable Federal regulatory standards.~   "
210432|NCT00806351|"~     The purpose of this study is to gather information on the use of anidulafungin for the~     treatment of Candida infection in patients with an abnormal immune system. It is expected~     that anidulafungin will be at least as safe and as effective as the comparator drug,~     caspofungin.~   "
210433|NCT00806338|"~     The purpose of this study is to evaluate the safety and tolerance of multiple intravenous~     (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.~   "
210434|NCT00806325|"~     Acute leukemia is a life threatening illness that strikes people of all ages. In addition to~     surviving the direct effects of the disease, the treatment of leukemia generally requires~     chemotherapy which has its own burden. Infection is one of the most common secondary problems~     faced by these patients. Simple infections are common and easily treated with aggressive~     antibiotics. However, treated progressive infection leads to loss of vital organ function and~     is termed severe sepsis. Severe sepsis is associated with increased risk of death and the~     need for specialized care in the intensive care unit.~      Besides the appropriate use of antibiotics, little is known about what clinical and patient~     factors are associated with the development of severe sepsis. Recent evidence has suggested~     that certain practices like frequent transfusion of blood products and control of glucose~     levels effects outcome in critically ill patients. In addition, there have been advances in~     our knowledge of certain genes that may predispose people to severe infections. It is~     possible that these factors are important in people who are not yet critically ill, but are~     at risk for the development of severe sepsis.~      This observational study will look at genetic, clinical and therapeutic factors that are~     associated with the development of severe sepsis. This will help doctors understand what~     treatments may be helpful in preventing this serious complication.~   "
210435|NCT00806312|"~     It is not always known what causes PAH or what the best treatment is. The doctors doing this~     study would like to understand more about why some people develop PAH and other do not. They~     also would like to learn more about which treatments might help PAH and which people might~     respond better to treatments.~      Doctors think that testing certain substances found in blood cells might help answer these~     questions. These substances are normally released by our bodies to protect us from infection~     and to tell the difference between normal and foreign substances in our body. Finally, a new~     test will study very small molecules called microRNA that control how our genes are~     expressed. This study is being done to see if blood samples can be tested to determine who~     might develop PAH, how well drugs will work to treat PAH and to learn more about the~     development of PAH.~   "
210436|NCT00806299|"~     A 10-day study to determine if grapefruit juice has any effect on how loperamide (Imodium)~     affects the body and how the body affects loperamide.~   "
210437|NCT00806286|"~     The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects~     with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in~     combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the~     study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin~     and paclitaxel to evaluate effectiveness and safety. The study will find out if adding~     CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in~     subjects with metastatic non-small cell lung cancer.~   "
210456|NCT00806026|"~     This purpose of this study is to investigate the efficacy and tolerability of pregabalin in~     treating idiopathic RLS patients for up to 12 months.~   "
210457|NCT00806013|"~     The aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on~     the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects.~   "
210458|NCT00806000|"~     This study is investigating how commonly exercise-induced asthma happens in athletes and the~     best way to diagnose exercise-induced asthma. Exercise-induced asthma describes narrowing of~     the airways in the lungs that occurs in certain people when they exercise. This can cause~     shortness of breath, cough, and fatigue during exercise and can impair athletic performance.~     Exercise-induced asthma can be difficult to diagnose. This is a research study, because the~     investigators are examining the best way to document a diagnosis of exercise-induced asthma.~     The investigators are also interested in examining why exercise-induced asthma may occur.~   "
210438|NCT00806273|"~     Study/Protocol Title: An in vivo comparison of the debridement efficacy of needle irrigation~     and ultrasonic root canal irrigation techniques~        1. The purpose of this study is to compare the Vista ultrasonic bypass system and~          conventional needle irrigation to effectively clean the bottom third of the root canal~          during root canal therapy.~        2. Participants will be recruited from the general patient pool of the OHSU School of~          Dentistry. Patients will have to qualify for the study by meeting the following~          criteria: age between 18 and 75 years old, ASA status I or II, are currently planning~          treatment for the extraction of teeth, and the patient understands and signs the consent~          form. The principal investigator will conduct an interview with the patient and the~          student-provider, and obtain informed consent from the patient.~        3. The teeth to be extracted will be numbed with local anesthetic. The teeth will be~          isolated with a rubber dam and disinfected. The pulp chamber will be accessed using~          normal dental equipment and the root canal will be cleaned and shaped using either the~          ultrasonic irrigation technique or needle irrigation. This is the first step of standard~          root canal therapy. The tooth will then be extracted and the principal investigator will~          retain extracted teeth to perform further examination to see how thoroughly the root~          canals were cleaned. The teeth will be discarded after study.~        4. The investigational device (Vista ultrasonic bypass system) consists of a 30 gauge slot~          needle which attaches to an ultrasonic unit (Satalec P5). Irrigants will be delivered to~          the apical 1/3 of the root canal through the needle at the same time the needle is being~          activated ultrasonically. Irrigant delivery will be controlled by a standard syringe~          pump. Conventional needle irrigation will be delivered using a 27guage slot needle~          placed into the root canal. Irrigants will be expressed with positive pressure at a~          location in the canal short of the needle binding~        5. Once the first step of root canal therapy has been completed, the tooth will be~          extracted, decalcified, and tissue specimens will be taken from the bottom 3 mm. These~          sections will be evaluated under magnification and remaining debris in the root canal~          will be quantified using the NIH Image software. The data will be statistically analyzed~          to determine and differences between the two irrigation techniques.~   "
210439|NCT00806260|"~     The purpose of this study is to determine how VI-0521 affect speed and reaction time on~     specific tasks that require eye and hand coordination, compared to placebo.~   "
210440|NCT00806247|"~     This study was to evaluate the efficacy and safety of dosing regimens of tapentadol HCl~     immediate release capsules for the treatment of postoperative pain over a period of 12 hours~     on the first day following a bunionectomy in men and women.~   "
210441|NCT00806234|"~     This study will test the effectiveness of two different treatments for children and~     adolescents who have gained weight on their antipsychotic medications.~   "
210442|NCT00806221|"~     The purpose of this study is to determine whether early use of a bland emollient in newborns,~     prior to the clinical signs of skin disease, will delay the onset or prevent the development~     of atopic dermatitis.~   "
210443|NCT00806208|"~     A trial to assess safety of four doses of MEDI 507 combined with another drug for initial~     treatment of at least Grade II acute Graft-vs-Host Disease in recipients.~   "
210444|NCT00806195|"~     The primary objective of this phase 3b study is to evaluate the safety and tolerability of~     Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to~     healthy infants~   "
210445|NCT00806182|"~     The purpose of this study is to determine if cytokines, inflammatory mediators, are increased~     in spinal fluid and blood, correlate with disease activity, and could serve as biomarkers or~     therapeutic targets in children with opsoclonus-myoclonus syndrome (OMS), an autoimmune~     complication of the tumor neuroblastoma.~   "
210446|NCT00806169|"~     The aim of this pilot study was to investigate the effects of an intravitreal combination~     therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic~     retinopathy.~   "
210447|NCT00806156|"~     This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients~     with metastatic or locally advanced platinum-resistant ovarian cancer.~      Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102~     will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be~     given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the~     initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional~     patients.~   "
210448|NCT00806143|"~     Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the~     treatment of resistant depression. No accordance exists on which are the involved mechanisms~     of action and on which stimulation parameters, frequency and side are optimal.~   "
210449|NCT00806130|"~     The purpose of this study is to assess health related quality of life and its predictors~     among chronic dialysis patients and to assess cognitive function using 3 different tests.~      (undergraduate medical student research project; not published)~   "
210450|NCT00806117|"~     Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of~     the survival over years. The risk of recurrence after radical surgery has increased with~     positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep~     invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical~     cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy~     can improve the overall survival rate of patients with adverse pathological prognostic~     factors is inconclusive.~      In this study, in order to investigate the effect and adverse reaction of chemotherapy as the~     adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine~     hundred and ninety patients will be randomly divided into three groups, comparing~     radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2~     cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The~     investigators aim to find out the best therapeutic regimen with lowest adverse reaction for~     cervical cancer with adverse pathological prognostic factors. To guide clinical treatment~     options.~   "
210451|NCT00806104|"~     Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the~     intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance~     of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable~     Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of~     fructo-oligosaccharides to improve IBS score and to explore which modifications of the~     microbiota are responsible of this improvement.~   "
210452|NCT00806091|"~     The purpose of this study is to obtain young white blood cells (monocytes) from the~     investigators donated blood for research into how these cells change into large, mature white~     blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease~     (COPD).~   "
210453|NCT00806078|"~     This is an open label randomized single dose two-way crossover study to compare the~     bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with~     120 ml of chocolate pudding relative to the same dose given as two intact capsules.~   "
210454|NCT00806065|"~     The study is designed to assess the safety, tolerability, maximum tolerated dose, and~     clinical benefit of treatment with ENMD-2076 administered orally once daily over a range of~     doses in patients with relapsed or refractory multiple myeloma.~   "
210459|NCT00805974|"~     The primary objectives are to compare the mean levels of the sleep quality parameters of~     subjects : with a nocturnal fall of the SBP (Systolic blood pressure), DBP (diastolic blood~     pressure) and MAP (mean arterial pressure) over of egal to 10% (dipping subjects) and of~     subjects with a nocturnal fall of SBP, DBP and MAP inferior to 10% (non dipper subjects).~      The secondary objectives are :~      Establish correlations between:~        -  The quality of sleep parameters~        -  The parameters of BP variations between the diurnal and nocturnal periods and the awake~          periods of sleep defined in reference to polysomnography.~        -  The glycemia levels on 24h with a glycemic holter. The parameters of the sympathic~          system activation evaluated in reference to the measure of the baroreflex sensibility~          during the awake period.~   "
210460|NCT00805961|"~     In this phase II trial the investigators plan to incorporate two targeted agents, bevacizumab~     and everolimus, into the first-line multimodality therapy of glioblastoma. In the first~     portion of the treatment, bevacizumab will be added to standard concurrent radiation therapy~     plus temozolomide. After completing radiation therapy, patients will continue treatment with~     the combination of bevacizumab and everolimus.~   "
210461|NCT00805948|"~     The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent~     Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following~     U.S. market approval.~   "
210462|NCT00805935|"~     This multicenter, randomized, open-label exploratory study will be performed in approximately~     200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro~     fertilization (IVF). Each study center will follow its standard practice for in vitro~     fertilization (IVF) within the study parameters as noted in this protocol. The study centers~     will use marketed products purchased from Schraft's Pharmacy for all phases of the study~     (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be~     randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim~     Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil~     for luteal support. Subjects will return to the study center for regular scheduled clinic~     visits as required per in vitro fertilization (IVF) protocol at the site and at specified~     times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and~     first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic~     gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at~     completion of luteal support or negative serum pregnancy test following embryo transfer.~   "
210463|NCT00805922|"~     This study is conducted in Asia. The aim of this observational study is to evaluate current~     status of diabetes management, control, complications in diabetic subjects in Thailand.~   "
210464|NCT00805909|"~     The purpose of the study is to determine the safety and tolerability of NI-0401 and whether~     NI-0401 can reverse BpACR.~   "
210465|NCT00805896|"~     Songyou Granule is a mixture of 6 herbs. Vitro and vivo studies showed that Songyou Granule~     can inhibit HCC cells grow, and HCC metastasis. Hypothesis of this study is that TACE plus~     Songyou Granule will improve outcome in patients with advanced hepatocellular carcinoma (HCC)~     compared with TACE.~   "
210466|NCT00805883|"~     This is a clinical research study designed to measure the effectiveness of focal Interstitial~     Laser Thermal Therapy (ILTT) at killing prostate tumours. Patients with low risk prostate~     cancer (Trans Rectal US Guided Biopsy positive) will undergo an MRI scan to try to localize~     the tumour. If the MRI detects the tumour they will then undergo a perineal ablative~     procedure (ILTT) under general anaesthetic. Seven days following ILTT they will come back to~     the hospital for a Radical Retoropubic Prostatectomy (RRP) procedure, which is the removal of~     a prostate gland through a surgical incision. After removal, the prostate will undergo~     further analysis to determine the exact location of cancer and evaluate the extent of cancer~     death caused by ILTT.~   "
210467|NCT00805870|"~     The purpose of this study is to determine the effects of fish oil supplementation (Lovaza,~     GlaxoSmithKline) on muscle strength, muscle soreness and inflammation following exercise.~   "
210468|NCT00805857|"~     The SCOLTA project is a system for online surveying of adverse events to recently~     commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events~     reactions arising during any antiretroviral treatment.Aim of the proposed study is:~        1. to evaluate the prevalence and incidence of serious adverse events and serious~          unexpected adverse events in HIV-infected patients enrolled in the SCOLTA project~          Tipranavir cohort and to identify possible risk factors~        2. the evaluation of tipranavir containing regimens durability, considering treatment~          interruption for each reason.~   "
210469|NCT00805844|"~     To determine if using usual clinical practice plus a depth of anesthesia monitor, SedLine, to~     guide anesthetic administration improves the quality and ease of MEP monitoring in patients~     undergoing corrective spinal procedures.~   "
210470|NCT00805831|"~     The HDH device is intended for creating sutureless vascular anastomosis in various blood~     vessels. The HDH device consists of four parts: an elastic tube (graft), docking head~     (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring~     device. This study was design in order to evaluate the safety and efficacy of using HDH~     device and method an innovative anastomotic device for sutureless aortic anastomosis in~     patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm.~   "
210471|NCT00805818|"~     The purpose of this study is to determine whether NNZ-2566 is safe and effective in the~     treatment of Traumatic Brain Injury (TBI).~   "
210472|NCT00805805|"~     The University of Michigan is conducting a study investigating a potential new treatment~     aimed at slowing/halting progression of primary biliary cirrhosis. This will be a 2 arm~     double blind study in which half of the patients will be randomly selected to receive a~     placebo (capsule with no active ingredient) and half will receive the new treatment drug,~     tetrathiomolybdate. Neither the patient nor the treating physician will know which arm the~     patient is in. The length of the study for each patient is 24 months of drug therapy. Lab~     draws will be necessary weekly for the first 6 weeks of the study, followed by every other~     week for 3 weeks, and then monthly for the remainder of the 2 year period. In addition,~     intermittent history and physicals and urine samples will also be necessary. There is no cost~     to you for any experimental treatment. All patients in both arms will continue on ursodiol~     and receive standard of care treatment~   "
210473|NCT00805792|"~     This study involves treating patients that have suffered an acute ischemic stroke with the~     medication donepezil (Aricept ®). The hypothesis is that taking donepezil (FDA-approved for~     the treatment of Alzheimer's Disease) for the first 90 days following a stroke enhances~     recovery.~   "
210474|NCT00805779|"~     To assess the initial safety and clinical feasibility of neuromodulation therapy in treating~     patients with documented overactive bladder. The specific aim is improved urinary frequency~     and urgency after 12 weeks of treatment~   "
210475|NCT00805766|"~     The purpose of this study is to assess the efficacy, safety and pharmacokinetics after~     administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an~     insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.~   "
210476|NCT00805753|"~     This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Acthar Gel) on the~     lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a~     hormone produced by the pituitary gland (a gland at the base of your brain) that is involved~     in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol,~     aldosterone, corticosterone, and others) that are important in keeping you alive. The drug~     used in this study has been approved by the Food and Drug Administration (FDA) for routine~     clinical use in the treatment of patients with proteinuria and patients with idiopathic~     nephrotic syndrome such as idiopathic MN. However, the most adequate dose to use has not been~     adequately assessed. This is the reason for conducting this research study.~   "
210477|NCT00805740|"~     The purpose of this study is to gather information on the use of anidulafungin for the~     treatment of serious Candida infection. It is expected that anidulafungin will be at least as~     safe and as effective as the comparator drug, caspofungin.~   "
210478|NCT00805714|"~     Statins are usually used in AMI patients due to its strong anti-lipidemic effect, pleiotropic~     effect and tolerable safety profiles. Generally AMI patients are prescribed many drugs~     concomitantly; there are some risks due to the drug interaction. Especially, statins are~     reported to have many drug interactions, these might influence to therapeutic prognosis and~     safety in AMI patients.~      This study is conducted to administer the non-CYP3A4 metabolized statin, pitavastatin to AMI~     patients over 1 year, and the results will be compared with the other results from the KAMIR~     study which is expected to the large scale of AMI patients using statins be enrolled.~     Finally, from that comparison, we will investigate the influence of the statins metabolism by~     CYP3A4 to the therapeutic prognosis like death, major adverse cardiac events(MACE), and major~     ADR of statins like CK increase, myalgia.~   "
210479|NCT00805701|"~     Avodart (dutasteride) reduces the male hormone (DHT) that leads to prostate growth and~     stimulates cancerous growth. Avodart is currently approved by the FDA to treat men with~     symptoms of an enlarged prostate. Avodart works by reducing DHT and prostate size; therefore,~     the drug may be useful in improving lower urinary tract symptoms (LUTS) such as frequency,~     urgency, weak stream, and urination difficulty (dysuria), among others, in men with prostate~     cancer. Avodart may be effective in men with prostate cancer who are being treated with~     hormonal therapy with one injection of Zolodex (goserelin) followed one month later with a~     trans-urethral incision of the prostate (TUIP), and three months after that, seed~     implantation (SI) of the prostate.~      The purpose of this study is to test whether Avodart (dutasteride) is effective on LUTS and~     dysuria in men with localized prostate cancer being treated with single-dose goserelin, TUIP,~     and interval SI.~   "
210480|NCT00805688|"~     The goal of this clinical research study is to learn about symptoms related to chemotherapy~     and the disease, in patients with advanced pancreatic cancer. Researchers will study the~     possible reason for these symptoms by drawing blood samples and comparing the test results to~     the symptoms you experience. The study will also use a special telephone system for measuring~     the symptoms of participants during and after therapy. Your level of physical activity will~     also be studied using a pedometer and study diary.~   "
210481|NCT00805675|"~     The purpose of this study is to compare the safety, tolerability and effectiveness of 12~     weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD)~     taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy~     daily (QD). This is an open labeled, active controlled, viral kinetics study which means the~     subjects and study doctor will know what study drug subjects have been assigned. This study~     is open to male and female subjects, <40 years of age, who have been infected with HBV for at~     least 6 months and have not received oral treatment for HBV.~   "
210482|NCT00805662|"~     Placebo-controlled study. Application of nasal oxytocin (8 IU) during intrauterine~     insemination in 86 patients.~   "
210483|NCT00805649|"~     The purpose of this study is to investigate the efficacy of combined intravitreal therapy~     with or without prior photodynamic therapy in patients with wet age-related macular~     degeneration (AMD).~      In patients with wet AMD, a significant improvement in vision was observed after combined~     intravitreal therapy with or without prior photodynamic therapy. Both the pharmacological~     effects of the drugs and the physiological effects of the pars plana vitrectomy (posterior~     vitreous detachment, liquefaction, and oxygen redistribution) may have contributed to the~     long-term sustainability of the therapeutic benefits.~   "
210484|NCT00805636|"~     The purpose of this study is to evaluate the potential of [18F]-ML-10 to serve as an imaging~     tool for the early detection of response of brain metastases to radiation therapy. Such early~     detection may help early identification of responsive and non-responsive lesions. The~     experimental design of the present study aims to evaluate the potential of PET imaging with~     [18F]-ML-10 to address the currently unmet clinical need for very early (within one~     day)assessment of response to therapy. Currently, response assessment is available only after~     several weeks or months after completion of therapy, when tumor shrinkage can be detected by~     anatomical imaging (by MRI). Early detection of tumor response to treatment is now~     widely-recognized as a highly-desirable goal in oncology, and is respectively the target of~     intense research worldwide. In the future, the option to know early upon treatment~     administration, that the treated tumor is a non-responsive, may improve clinical management~     of patients with brain metastases of solid tumors.~   "
210485|NCT00805623|"~     Sucking and sucrose have been shown to reduce pain during venous puncture in neonates. Our~     study is designed to see if sucking and sucrose relieve pain during venous puncture in~     infants age 3-12 months.~   "
210486|NCT00805610|"~     The investigators research will examine the safety and efficacy of hepatocyte transplantation~     in the patient with acute liver failure without history of chronic disease. The investigators~     will study the effectiveness in providing a bridge of support for patient survival until~     whole organ transplantation is possible. This support may also be a bridge to recovery; by~     allowing the native liver to recover so that orthotopic liver transplant is not necessary.~      The investigators will also study the safety and efficacy of hepatocyte transplantation in~     the patient with chronic liver disease. Underlying etiologies of chronic disease may arise~     from cirrhosis, fibrosis or inherited metabolic disorders. The investigators will examine~     cell transplantation in end-stage patients not eligible for whole organ transplant. These~     patients may benefit with an amelioration of symptoms that will allow other therapeutic~     treatments.~      The investigators study will also examine the ability of transplanted hepatocytes to treat~     inherited metabolic diseases (ex., Crigler-Najjar Disease, Familial Hypercholesterolemia,~     Urea Cycle Disorders). Cell transplant may also act as a 'bridge' to whole organ transplant~     or improve function, permitting easier disease control through traditional therapy.~   "
210487|NCT00805597|"~     The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer~     patients with one to three positive nodes.~   "
210488|NCT00805584|"~     The purpose of this study was to test the effectiveness and side effects of desloratadine~     (Aerius) in patients with hayfever. Patients took desloratadine once a day for 15 days. At~     the end of therapy, they scored how severe their hayfever symptoms were and how they~     responded to therapy. Side effects were recorded.~   "
210489|NCT00805571|"~     The purpose of this study is to determine if measuring the level of a protein called Kidney~     Injury Molecule-1 (KIM-1) in the urine will help healthcare providers detect any problems~     with the transplanted kidney before the laboratory investigations that are used on a routine~     basis do. This approach may allow the doctor to intervene at an earlier point of a rejection~     episode and may thereby prolong survival of the transplant kidney.~   "
210490|NCT00805558|"~     The purpose of this study is to assess the clinical and microbiological effectiveness of the~     moxifloxacin compared with the combination ciprofloxacin - metronidazole, when used as~     adjunctive therapy to scaling and root planning for the treatment of advanced chronic~     periodontitis.~   "
210491|NCT00805545|"~     The current standard of care to prevent post partum infectious morbidities is to administer~     antibiotic prophylaxis to all women undergoing a cesarean delivery. The general practice is~     to administer the antibiotic immediately after the umbilical cord is clamped. This study will~     compare the incidence of post partum infectious morbidities when the extended spectrum~     prophylaxis given before the incision time vs. the time of cord clamp.~   "
210492|NCT00805532|"~     The present study is a randomized, controlled trial that compares Behavioral Activation (BA),~     to Usual VA Care (UC) as early psychotherapeutic interventions for OIF/OEF veterans with~     posttraumatic stress disorder (PTSD), or PTSD and major depressive disorder (PTSD/MDD).~   "
210493|NCT00805519|"~     This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine~     add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee~     which will be done in contrast to combined glucosamine sulfate and chondroitin.~   "
210494|NCT00805506|"~     Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to~     identify periods throughout the day when glucose varies significantly.~   "
210495|NCT00805493|"~     Pediatric Bipolar Disorder (BD) is uncommon in children. Its symptoms include periods of~     manic behavior (being overly happy or giddy, feeling grandiose, feeling a decreased need for~     sleep, having too much energy, moving more than usual, talking fast, having speeded-up~     thoughts and other symptoms). Sometimes there also is depression (extreme feelings of sadness~     or irritability, not taking pleasure in things, even ones that used to be enjoyable, feeling~     worthless or guilty, sleeping too much or having trouble getting to or staying asleep,~     feeling slowed down or restless, having wishes to be dead or suicidal ideas, and other~     symptoms). Pediatric BD is often difficult to treat; children may respond only partially to~     the medications now available or have too many side effects to tolerate them.~      Riluzole is a medication that is thought to work on a brain chemical called glutamate that~     may be involved in symptoms of depression and BD. Previous research studies have shown that~     riluzole may help adults with BD who have depression and adults who have depression, anxiety~     disorders, or obsessive-compulsive disorders. Riluzole may also be helpful for children with~     obsessive-compulsive disorder. However, it has never been given to children with BD.~      This study will evaluate the effectiveness of riluzole in 80 patients between 9 and 17 years~     of age who have BD and symptoms of anxiety. Participants must have tried at least two other~     medications that have not been effective.~      The study will consist of four phases carried out over 4 to 5 months. Most children will be~     inpatients at the Pediatric Behavioral Health Unit for at least part of the study.~      In Phase 1, each patient will undergo blood and urine tests, and will gradually taper off his~     or her medication. The duration of this phase depends on the medication that the patient was~     receiving before starting the study.~      In Phase 2, the patient will remain off all medication for 1 week. Throughout this time,~     patients will be monitored carefully and medication will be restarted if needed.~      In Phase 3, which lasts 8 weeks, patients will be assigned randomly to receive only riluzole~     or only a placebo. Those who receive riluzole will have the dose adjusted as needed. Patients~     and families will be informed of which drug they were on at the end of this phase. Patients~     who improved on riluzole may continue to receive it from NIH for 1 month and will then be~     prepared for discharge from the study. Patients who received placebo and improved, and those~     who received riluzole but did not improve, will be treated with standard medications as~     appropriate and prepared for discharge from the study.~      Phase 4 is for patients who received placebo and did not improve. They will be given the~     chance to try riluzole for 8 weeks and, if it is effective, continue it for an additional 4~     weeks while they prepare to be discharged from the study.~      Patients will not be able to receive riluzole at the National Institutes of Health after the~     completion of the study. However, the child's doctor may be able to prescribe riluzole as an~     off-label use.~      Most patients will be admitted to the Pediatric Behavioral Health Unit at the National~     Institutes of Health Clinical Center during the medication withdrawal part of the study~     (Phases 1 and 2). From Phase 3 on, a patient may participate as an inpatient, outpatient, or~     in day treatment, depending on what is in his or her best interests.~      All participants in this study will be invited to also enroll in the National Institute of~     Mental Health protocol 00-M-0198, The Phenomenology and Neurophysiology of Affective~     Dysregulation In Children And Adolescents With Bipolar Disorder. Some research tests for that~     protocol will be done during the medication-free period of this protocol.~   "
210496|NCT00805480|"~     Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing~     single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to~     severe chronic plaque psoriasis.~   "
210497|NCT00805467|"~     The purpose of this new research study is to gain additional information about how safe and~     effective R935788 is over a longer period of time.~   "
210498|NCT00805454|"~     Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht~     dose levels in healthy volunteers.~   "
210499|NCT00805441|"~     H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with~     placebo in a 12-week trial that includes Medical Management. This study is an outpatient~     study in which approximately 180 alcohol dependent subjects will be enrolled. Subjects will~     be randomized in a 1:1 fashion to LY686017 or placebo, and will receive once daily dosing for~     twelve weeks.~   "
210500|NCT00805428|"~     Mucosal inflammation in patients with UC is the result of immunosuppression disturbance~     because decreasing number of regulatory T ly and activation IL 17~   "
210501|NCT00805415|"~     The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral~     contraceptive regimens.~   "
210502|NCT00805402|"~     The aim of this study is to show that flow cytometry can be an accurate tool to help~     physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom~     allergy.~      75 patients having a story of reaction to hymenoptera venom will be selected for this trial.~      Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and~     Week 21 visit.~   "
210503|NCT00805389|"~     The aim of this Observer-blind study is to compare different Adjuvant Systems with the same,~     well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B~     (Engerix-BTM and FendrixTM), in order to better understand the immune response induced by~     each of the Adjuvant System.~      This Protocol Posting has been updated following Protocol amendment 6, October 2009. The~     section impacted is Eligibility Criteria~   "
210504|NCT00805376|"~     The goal of this clinical research study is to find the highest tolerable dose of DNX-2401~     that can be injected directly into brain tumors and into the surrounding brain tissue where~     tumor cells can multiply. A second goal is to study how the new drug DNX-2401 affects brain~     tumor cells and the body in general.~   "
210541|NCT00804882|"~     The investigators aim to examine how medical conditions that indicate high cardiometabolic~     risk, such as increased body weight, high cholesterol levels and high blood pressure, affect~     heart structure and function among individuals with known HF. Furthermore, this study is~     being undertaken to identify potential differences in these effects between non-Hispanics~     whites and Mexican Americans.~   "
210617|NCT00803881|"~     Aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization~     of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with~     cystic fibrosis.~   "
210505|NCT00805350|"~     Primary objective:~      - To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of~     treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake~     Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW).~      Secondary objectives:~        -  To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of~          treatment on other sleep parameters measured by PSG recordings (Total Sleep Time -~          PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported~          by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total~          Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS).~        -  To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to~          placebo.~        -  To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep~          Impact Scale (SIS), as compared with placebo after 6 weeks of treatment.~        -  To evaluate patient's impression of treatment effects using the Patient's Global~          Impression questionnaire.~        -  To evaluate the potential for next-day residual effects (using patient's morning~          questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo.~        -  To evaluate the potential for rebound insomnia following abrupt discontinuation of~          eplivanserin 5mg/day in comparison with placebo.~        -  To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of~          patients with primary insomnia using the SF-36 Health Survey.~        -  To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to~          placebo.~   "
210506|NCT00805337|"~     Following the discovery of tumor-specific frequencies in patients with advanced cancer,~     compassionate treatment with tumor-specific frequencies administered at levels that are~     significantly below the levels generated by cell phone will be offered to patients with~     limited therapeutic options.~   "
210507|NCT00805324|"~     The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius)~     syrup in children with hayfever with or without asthma. Patients took desloratadine syrup~     once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The~     doctor also rated how much relief the patient got from treatment and recorded any side~     effects.~   "
210508|NCT00805311|"~     The aim of this study is to determine whether optimal medical treatment can postpone carotid~     endarterectomy.~   "
210509|NCT00805298|"~     The aim of this study is to compare postoperative complications after removal of lower third~     molars using two different types of anaesthetics and two different treatments against~     swelling and inflammation (methylprednisolone and placebo). The hypothesis is that a~     combination of a long-duration anaesthetic combined methylprednisolone will result in~     significantly less postoperative pain and inflammation.~      Patients will have both lower third molars removed on two separate occasions. Each patient is~     randomly assigned to receive one type of local anaesthetic the first time and the other type~     the second time. Furthermore patients are randomised to receive either methylprednisolone or~     placebo the first time and the opposite treatment the second time.~      During the week after surgery patients fill out a questionnaire with questions about level of~     pain and swelling at different times as well as the patients' perception of other~     postoperative complications. The patient is examined by a dentist on the 2nd and 7th day~     after surgery, where postoperative complications are recorded and thermographic images of the~     patient's face are taken to assess the degree of inflammation.~   "
210510|NCT00805285|"~     The purpose of this study is to evaluate if the combination of oral budesonide and rectal~     hydrocortisone improves symptoms in patients with active ulcerative colitis. Also, we would~     like to determine if oral budesonide and rectal hydrocortisone has fewer and less severe side~     effects compared to standard steroids (prednisone).~   "
210511|NCT00805272|"~     Tuberculosis is a current infection during HIV infection. After infectious contact, some~     patients will develop tuberculosis some will only be infected without symptoms, they have~     Latent Tuberculosis Infection (LTBI) which can reactivate later.In order to prevent this~     tuberculosis reactivation, LTBI diagnosis screening is preconised in HIV-infected patients.~     This diagnosis is made till now by the tuberculin skin test (TST) but this test is not~     specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific po MTB infection are now sold~     but have not been evaluated in immunocompromised HIV-infected patients.~      The primary endpoint of this study is the evaluation of the theoretic therapeutic impact of~     the use of IGRAS for diagnosis of LTBI in HIV-infected patients~   "
210512|NCT00805259|"~     In this between-subject randomized controlled trial the investigators will test the impact of~     three novel structured financial incentives: atomistic, altruistic and team-based. These~     incentive schemes will be used to motivate one month of daily use of software designed to~     improve cognitive function (including memory, reaction times, attention and executive~     function) among the elderly. The 400 participants will be members of retirement communities~     in Pennsylvania. Three outcomes will be monitored and analyzed: activities completed using~     the software (primary), performance on the activities, and changes in cognitive functioning.~     This study is designed to be a pilot study. The investigators will have 90% power to find a~     mean daily difference of 4 activities completed in the control group versus 7 activities~     completed in the incentive groups assuming a standard deviation of 3.5 and an alpha of 0.017~     (the bonferroni corrected significance level to account for multiple comparisons). In~     addition during a three month follow-up period all participants will have continued access~     to the software, however, no incentives will be provided for use. This period will be used to~     assess the impact of the initial incentives on long run use after financial incentives have~     ceased.~   "
210523|NCT00805116|"~     NSAIDS are associated with adverse GI effects and COX-2 inhibitors have cardiovascular risk.~     Long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis~     (R.A) patients, with reduced need for NSAIDS, in addition to being cardioprotective. The aim~     is to investigate if 4 month supplementation of 15 ml/day of whale blubber oil compared with~     cod liver oil reduce the intensity of joint pain in patients with R.A (primary outcome).~     Patients are assessed at inclusion and after study (4 months) during routine polyclinical~     visit. Patients are called for interview after 6 and 12 weeks. Secondary outcomes are e.g.~     morning stiffness, quality of life and functional level~   "
210618|NCT00803868|"~     The purpose of this study is to determine if varenicline is effective in treating symptoms of~     Friedreich's ataxia.~   "
210513|NCT00805246|"~     Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and~     pulmonary embolism (PE), is a common but elusive illness that can cause significant~     disability and death if not promptly diagnosed and effectively treated. The annual incidence~     of VTE in the United States is estimated at 1 per 1000. Death occurs in approximately 12% of~     PE cases within 1 month of diagnosis. At present, clinical management of VTE and PE is~     hampered by gaps in our understanding of pathogenic mechanisms, the wide variety in patient~     populations, and incomplete understanding of the long term risks of recurrence and death.~     Given the complex presentation and risk associated with these conditions, proper risk~     assessment and subsequent prophylaxis for all at-risk patients is crucial. While clinical~     prediction rules have been recently developed to associate short-term risks and to stratify~     patients with acute PE, there is a dearth of objective biomarkers that can be related to the~     long-term prognosis of the disease. In addition to clinical information, clot burden is known~     to be strongly associated with clinical outcome of recurrent VTE. The quantification of clot~     burden requires imaging.~      CT Pulmonary Angiography (CTPA) has been established as a reference imaging standard in the~     diagnosis of PE. In addition to its role as a superb diagnostic tool, CTPA contains a wealth~     of information including characteristics of the clot that may be used as biomarkers~     associated with prognosis of PE. The work proposed in this application takes advantage of~     widely available CTPA imaging biomarker data and extends and advances clinical PE risk~     prediction model to include long term (2-year) survival as well as the clinically important~     outcome of recurrence. The primary objective of this proposal is to develop and identify CTPA~     imaging biomarkers that are associated with short-term and long-term prognoses of patients~     who were positively diagnosed for PE by CT. The rationale for this proposal is that CT~     imaging is a rich source of imaging biomarkers that may be associated with prognosis of PE.~     This information will help advance our understanding of the risk and recurrence of PE and~     provide a new insight to prognosis and clinical management and treatment of PE. This proposed~     research is innovative in that we have developed new CT imaging biomarkers and designed a~     clinical trial to assess and validate the prognostic values of these biomarkers. Our central~     hypothesis is that CT imaging biomarkers are associated with the risk of death and recurrence~     in patients with PE. The specific aims of this proposal are: (1) to quantify and characterize~     pulmonary emboli (volume and distribution) and comorbid cardiovasculopulmonary findings from~     CT images of patients who were positively diagnosed for PE by CT; (2) to identify CT imaging~     biomarkers that are associated with the prognosis of patients who were positively diagnosed~     for PE by CT, and to develop risk prediction tools for death and recurrence; and (3) to~     prospectively validate the risk prediction tool, and identify whether the change in CT~     imaging biomarkers of PE after initiation of therapy improve the predictive ability for~     recurrence and death.~   "
210514|NCT00805233|"~     This open-label, randomized, Phase II research study will look to see whether an~     investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal~     injection is safe and effective for treating wet AMD as compared to ranibizumab alone.~   "
210515|NCT00805220|"~     The elderly are the fastest growing proportion of the population. Ageism implies a decline of~     physical functions affecting functional and safe ambulation. Based on the ICF model~     intervening in walking capacity could have favourable impact on quality of life of frail~     elders. Over ground walking training is indicated as a possible exercise. However, to achieve~     positive results on walking capacity, an exercise-dose response is needed. A more intensive~     way of promoting walking training is to add skiing poles while walking, a technique called~     Nordic Walking (NW). This study will be the first to compare NW with usual walking training.~     It aims to estimate for frail elderly the relative efficacy in improving functional walking~     capacity of two gait training strategies: NW and usual walking training and explore its~     impact on fear of falling. This study hypothesized that participants receiving Nordic Walking~     will walk longer, faster and fear less. NW if proven effective will positively impact on the~     functional capacities and quality of life of frail elders and provide an more intense method~     of walking training.~   "
210516|NCT00805207|"~     Increased plasma triglyceride concentration is a common feature of the metabolic~     abnormalities associated with obesity and a major risk factor for cardiovascular disease.~     Obesity is a major risk factor for two conditions that appear to be increasing in prevalence~     in women: the polycystic ovary syndrome and sleep disordered breathing. PCOS affects 5-8% of~     women. Sleep disordered breathing affects up to 10% of women. Obstructive sleep apnea is the~     most common cause for sleep disordered breathing and particularly prevalent in obese women~     with PCOS (~50%). Both PCOS and OSA augment the increase in plasma TG concentration~     associated with obesity, and the effects of polycystic ovary syndrome and obstructive sleep~     apnea on plasma TG concentration appear to be additive. The mechanisms responsible for the~     adverse effects on plasma TG metabolism are not known. The primary goal of this project,~     therefore, is to determine the mechanisms responsible for the increase in plasma triglyceride~     concentration in obese women with polycystic ovary syndrome and obstructive sleep apnea. It~     is our general hypothesis that alterations in the hormonal milieu that are characteristic of~     these two conditions are, at least in part, responsible for the increase in plasma TG~     concentration in obese women with the conditions. Furthermore, we hypothesize that the~     hormonal aberrations characteristic of the two conditions are particularly harmful to obese,~     compared with lean, women.~      The effects of PCOS on skeletal muscle protein metabolism are also not known. However, sex~     hormones are thought to be important regulators of muscle protein turnover suggesting that~     muscle protein metabolism is likely to be affected by PCOS. We will examine this by~     determining the effect of individual sex hormones on muscle protein metabolism and~     hypothesize that testosterone administration will stimulate muscle protein metabolism while~     estrogen and progesterone administration will inhibit muscle protein metabolism.~   "
210517|NCT00805194|"~     The present trial will be performed to evaluate whether BIBF 1120 in combination with~     standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more~     effective as compared to placebo in combination with standard therapy of docetaxel. A~     secondary aim is to obtain safety information as well as information on quality of life of~     patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In~     addition, blood will be collected for pharmacokinetic analysis.~   "
210518|NCT00805181|"~     The objective of this study is to explore the kinetics of biomarkers in 30 adult female~     patients with uncomplicated acute pyelonephritis.~   "
210519|NCT00805168|"~     To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg~     (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System~     (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal~     saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and~     mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint~     objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized~     placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on~     ventilation, and the days in the intensive care unit (ICU).~   "
210520|NCT00805155|"~     The purpose of this study was to compare the relative vasoconstrictive effects of two test~     and one reference Mometasone Furoate 0.1% Topical Lotions in healthy, female subjects.~   "
210521|NCT00805142|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the~     drug is absorbed in the body, distributed within the body, and how it is removed from the~     body over time; explores what the body does to the drug) of tapentadol prolonged release~     (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and~     spreads in the body until it kills) pain.~   "
210522|NCT00805129|"~     The purpose of this study is to learn what effects, good and/or bad, Everolimus has on~     advanced urothelial cancer.~      The goal of this clinical research study is to learn if the study drug Everolimus can shrink~     or slow the growth of urothelial cancer. The safety of this drug will also be studied. The~     patients physical state, changes in the size of the tumor, and laboratory findings taken~     while on-study will help us decide if Everolimus is safe and effective.~   "
210540|NCT00804895|"~     the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of~     the greater occipital nerve to diminish the frequency of cluster headache (episodic or~     chronic) attacks during an active period. Injections will be used in adjunct with oral~     verapamil.~   "
210619|NCT00803855|"~     The primary purpose of this study is to assess the safety and tolerability of AZD1446~     following single dose administration.~   "
210524|NCT00805103|"~     Brain metastases occur in 20% to 40% of all patients with cancer , with an incidence 10 times~     higher than that of primary malignant brain tumors. Patients with brain metastases have a~     poor prognosis with a median survival of 1-2 months with corticosteroids and 5-7 months with~     whole brain radiotherapy (WBRT). Local control achieved with WBRT in patients with otherwise~     controlled systemic disease remains at issue. A single high dose of radiation delivered with~     high precision to the target lesion (Stereotactic radiosurgery (SRS)), is considered standard~     care in salvage of recurrent lesions after WBRT. SRS can destroy tumour with very little~     damage to surrounding tissue. Research suggests that delivering radiotherapy in a number of~     smaller doses is more beneficial than receiving all of the radiotherapy in a single dose.~     Brain metastases are well suited for SRS as they are often small, radiographically~     well-circumscribed, pseudospherical tumors that are noninfiltrative.~   "
210525|NCT00805090|"~     An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in~     subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic~     hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a~     randomized, open-label, crossover study in which they will receive Sporanox® to compare the~     safety and pharmacokinetics of HPβCD when administered in DIC075V compared to Sporanox®.~   "
210526|NCT00805077|"~     The purpose of this trial is to evaluate the efficacy and the safety of lung protective~     ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung~     cancer.~   "
210527|NCT00805064|"~     The aim of this pilot study was to investigate the effects of an intravitreal combination~     therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).~   "
210528|NCT00805051|"~     Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by~     degeneration of the polymers during passage through the narrow valve leading to turbulences.~     We hypothesized that the diagnosis of acquired von Willebrand syndrome influence~     perioperative blood loss in patients undergoing open cardiac valve replacement.~   "
210529|NCT00805038|"~     Compared with chronic dialysis treatment, kidney transplantation generally offers a longer~     life span, a better quality of life, and lower health care costs for the over 500,000~     Americans with End Stage Renal Disease. Despite Medicare funding of virtually all kidney~     transplants, minority, female, and poor patients with End Stage Renal Disease have decreased~     access to kidney transplantation. In prior work, the investigators identified the steps in~     the transplant process that are responsible for creating these disparities. These include~     medical suitability, interest in receiving a transplant, referral to a transplant center for~     a pre-transplant workup, placement on a waiting list or identification of a living donor, and~     receipt of a kidney from a deceased or living donor. The investigators now propose to train~     transplant recipients to act as transplant navigators and then test the value of using~     transplant navigators to help patients and providers complete these steps.~      The proposed community-based randomized controlled trial will involve approximately 75-100~     adult hemodialysis patients at intervention dialysis facilities and approximately 75-100~     patients at control facilities to compare a transplant navigator intervention with usual care~     over a 24 month interval. Baseline evaluation will include sociodemographic and medical~     characteristics, specific steps completed in the transplant process, and barriers to moving~     forward in the transplant process. At periodic intervals, the navigator will provide tailored~     information and assistance to patients and their nephrologists to help them complete the~     tasks required at each step. The major outcome will be completion of additional steps in the~     transplant process. Secondary analyses will examine impediments to successful intervention~     among subjects who fail to move forward in the transplant process despite assistance from a~     navigator.~      The proposed project will test a novel intervention that targets patients and nephrologists~     as they together make transplant-related decisions. Future work will involve determining the~     impact of navigators on disparities in transplant rates, examining the cost-effectiveness of~     transplant navigators, and disseminating the intervention for use across the country. Helping~     patients complete steps in the transplant process may lead not only to improved access to~     kidney transplantation but also to better patient survival, decreased health care costs, and~     increased quality of life.~   "
210530|NCT00805025|"~     Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total~     of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The~     Quality of Life-Bronchiectasis (QOL-B) questionnaire was completed at several time points~     during the study, in additional to pulmonary function testing and other standard procedures.~   "
210531|NCT00805012|"~     To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and~     neck squamous cell carcinoma~   "
210532|NCT00804999|"~     Assess the usefulness of using confocal microscopy to examine changes to the structure of the~     cornea and to identify any potential consequences of contact lens wear and/or solution use.~   "
210533|NCT00804986|"~     A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients~     with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet~     and exercise alone, or in combination with metformin, will be enrolled. The primary objective~     of this study is to test the hypothesis that LY2428757 given to patients with T2DM~     inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a~     significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks~     as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week~     safety follow-up.~   "
210534|NCT00804973|"~     This is a Phase 2, multicenter, randomized, double-blind, placebo and active~     comparator-controlled study of LY2590443 in approximately 200 subjects with migraines.~   "
210535|NCT00804960|"~     This research is being done to determine whether the success rate of in vitro fertilization~     treatment can be improved, while lowering the cost incurred from infertility medications~     using a pill called letrozole.~   "
210536|NCT00804947|"~     Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen~     for patients with Multiple Myeloma.~   "
210537|NCT00804934|"~     The purpose of this study is to determine whether people who have received intermittent~     anti-VEGF therapy have an improvement in vision after being switched to monthly injections of~     Lucentis.~   "
210538|NCT00804921|"~     Purpose: To evaluate the effects of anterior chamber paracentesis, brimonidine and oral~     acetazolamide to reduce intra-ocular pressure (IOP) variations after intravitreal bevacizumab~     injection (IVBV).~      Methods: 47 patients scheduled for IVBV (1.5 mg / 0.06 ml) will be randomly assigned to a~     pre-treatment 1 hour before IVBV with either 250 mg oral acetazolamide (DIA, 9 eyes),~     anterior chamber paracentesis immediate after IVBV (PAR, 15 eyes), topic brimonidine~     tartarate 1 hour before IVBV (BRI, 14 eyes), or no pre-treatment IBVB (CTR, 9 eyes). IOP will~     be measured 90 minutes before injection (baseline), just before injection, and at 3, 10, 20~     and 30 minutes after the procedure.~   "
210539|NCT00804908|"~     The purpose of this study is to evaluate the efficacy of ABT-888 in combination with~     temozolomide versus temozolomide alone in subjects with metastatic melanoma.~   "
210675|NCT00803127|"~     This study is designed to demonstrate the result reading clarity of the VS-SENSE is~     substantially equivalent to the result reading clarity of the Nitrazine pH Paper test for~     vaginal secretions.~   "
210542|NCT00804869|"~     Ultrasonography has become a critical ancillary test in the clinical practice of~     ophthalmology. It is commonly used as a standardized method for assessing intraocular~     biometry. The PalmScan ultrasonography (PsU) is a portable A-scan device that uses the same~     principles as the standard A-scan. The aim of the study is to compare the reliability of~     their measurements, in order to use them indistinctively.~   "
210543|NCT00804856|"~     The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I~     part of the trial, BI 6727 will be investigated as monotherapy and in combination with low~     dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for~     intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated~     dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients.~     In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C~     monotherapy will be investigated to explore the efficacy of the combination schedule in~     comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible~     for intensive treatment.~   "
210544|NCT00804843|"~     This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers~   "
210545|NCT00804830|"~     Anaplastic Thyroid Cancer is a very aggressive disease. The investigators believe that~     angiogenesis is very important for these tumors to progress. Preclinical data is suggesting~     this. This is why we we prospectively want to treat these patients with avastin (and~     doxorubicin). However, local control is of major concern. Therefore, patients are initially~     treated with hyperfractionated radiotherapy and undergo surgery. Then they can enter this~     study.~   "
210546|NCT00804817|"~     This study will test the SCION (Self care improvement through oncology nursing)-HSCT program~     a multi-modular, somatic-psycho-social care intervention to improve self management in~     oncologic patients undergoing HSCT. The study will determine if the self management skills of~     the patients to enhance:~        -  physical activity,~        -  prevention of oral mucositis and~        -  mal nutrition during the period of hospitalization.~      It is hypothesized that patients who receive the multi-modular somatic-psycho-social care~     intervention will have better health related quality of life (HRQoL).~   "
210547|NCT00804804|"~     The aim of the study is to determine the impact of aging, circadian rhythms and sleep~     deprivation on executive performances. Volunteers will complete a 40-hour extended~     wakefulness period in constant condition (semi-recumbent posture in bed, constant dim light~     levels < 10 lux, food and liquid intake at regular intervals) in order to control the~     circadian system. The volunteers will not be allowed to sleep in the sleep deprivation~     protocol (high sleep pressure protocol) and will adopt a short wakefulness/sleep cycle~     (150/75 minutes) in the multiple nap protocol (low sleep pressure protocol). Tests and~     scales will be repeated every 3H45~   "
210548|NCT00804791|"~     The objective of this study is to measure ocular surface residence time (in minutes) of two~     marketed OTC ophthalmic products in dry eye patients.~   "
210549|NCT00804778|"~     It's reported that USCOM can be used to measured patients' CO and CI conveniently, accurately~     and not confined to place, because of it's no aggressive, it's accuracy is doubtful.~   "
210550|NCT00804765|"~     Metabolic environment of the foetus during pregnancy in obese women is altered and the child~     exposed at an increased risk of obesity. Rapid infancy and childhood weight gain is~     associated with subsequent obesity.~      The purpose of the study is to test the efficacy of an educational intervention during~     pregnancy in obese or overweight women, on the reduction of rapid infancy weight gain in the~     two first years of life.~   "
210551|NCT00804752|"~     We hypothesize that patients with Ch.HCV have a low level of vitamin D, and that by raising~     their vitamin D levels by adding it to their standard treament of Pegylated Interferon and~     Ribavirin, there will be an increase in their sustained virological response.~   "
210552|NCT00804739|"~     The purpose of this project is to test whether a new model of collaborative care depression~     treatment adapted to the needs and preferences of low-income, urban mothers with perinatal~     depression and to a pediatric clinic setting increases engagement in and adherence to~     perinatal depression treatment.~   "
210553|NCT00804726|"~     The objective of this 12-month clinical investigation is to evaluate the safety and~     effectiveness of the Bausch & Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness~     will be shown through the demonstration of accurate distance correction and safety will be~     demonstrated through the monitoring of adverse events.~   "
210554|NCT00804713|"~     The overall objective of this study is to assess the feasibility and potential impact of~     using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for~     latent tuberculosis (TB) infection (LTBI) among military recruits. The current policy of~     universal application of the Mantoux tuberculin skin test (TST) to screen for LTBI may result~     in many TST reactions among recruits who are at low risk for LTBI. The central hypothesis is~     that targeted testing by use of the questionnaire will reduce unnecessary testing of low-risk~     recruits without affecting the identification of higher-risk recruits. The secondary~     hypothesis is that many discordant results between the TST and IGRA may be explained by~     cross-reactivity to non-tuberculous mycobacteria (NTM) with the TST.~   "
210555|NCT00804700|"~     The purpose of the study is to compare two different methods of listening to music while~     performing aerobic exercise: synchronous music listening vs. asynchronous music listening.~     Synchronous music listening while exercising is a learned activity where the participant~     moves his or her body in synchrony with the beat of the music, similar to dancing or to~     participating in a group exercise (aerobics) class. Our hypothesis is that synchronous music~     listening reduces the level of perceived exertion to the exercise and motivates the subject~     to exercise more often. This study randomly assigns 46 subjects, age 20-55 years old to~     either a control group of listening to their own favorite music in an asynchronous fashion or~     to an intervention group of listening to prepared music in a synchronous fashion over a six~     week period.~   "
210556|NCT00804687|"~     The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and~     pseudoephedrine compared to placebo (medication with no active ingredients) in participants~     with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen,~     dust or animal hair).~   "
210557|NCT00804674|"~     patients are given bupivacain intermittent locally on the donor site after brest~     reconstruction with diep flap. The hypothesis was that this approach will reduce the need for~     rescue analgetic medication and pain perception within the three first days~   "
210558|NCT00804661|"~     The aim of the study is to identify the parameters that are associated with nocturnal~     hypoventilation in children and adults with cystic fibrosis. Included patients will undergo a~     nocturnal evaluation of their gas exchange and sleep quality by actigraphy during their~     annual check up. The aim is thus to identify which parameters (such as lung function~     parameters) are associated with nocturnal hypercapnia or hypoxemia and/or poor sleep quality~   "
210559|NCT00804648|"~     This study compares patient symptoms and anterior segment safety in patients treated with~     timolol hemihydrate, generic timolol gel forming solution or timolol maleate.~   "
210560|NCT00804622|"~     The purpose of this study is to compare the safety, tolerability and effectiveness of 12~     weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg once daily (QD)~     taken together versus tenofovir DF 300 mg once daily (QD) or versus telbivudine 600 mg~     monotherapy daily (QD). This is an open-labeled, active controlled, viral kinetics study~     which means the subjects and study doctor will know what study drug subjects have been~     assigned. This study is open to male and female subjects, <40 years of age, who have been~     infected with HBV for at least 6 months and have not received oral treatment for HBV.~   "
210561|NCT00804609|"~     To evaluate the levels of morphine in a patient's blood when morphine is given into the~     epidural space in the form of DepoDur® either alone or following a dose of lidocaine also~     given in the epidural space.~   "
210562|NCT00804596|"~     The purpose of the study was to evaluate the acceptability of product user guides for~     untrained subjects and to evaluate the performance of the system with lay users and~     healthcare providers (HCPs).~   "
210563|NCT00804583|"~     This study examines modifier genes that may play a role in the development of CF liver~     disease. Modifier genes are genes, other than the CF gene (CFTR), which may directly or~     indirectly have an affect on how the body responds to the conditions that develop as the~     result of the defective CFTR gene. Scientists have wondered why some patients with CF develop~     CF liver disease and why some patients with CF do not. To better understand the problem, this~     study was designed to examine the genetic makeup of CF patients who are considered to have~     severe liver disease to see if they can identify any modifier genes. Researchers will study~     blood samples, pulmonary function tests, and other medical information in hopes that a~     connection can be made between genetic make-up and how severe the liver disease is. The~     identification of modifier genes that influence disease severity may ultimately lead to a~     better understanding of CF liver disease, and may be useful in the development of new~     treatments.~   "
210564|NCT00804570|"~     The Primary objective of this study is to test whether LY2196044 can reduce the number of~     heavy drinking days per month in people with alcohol dependence. Each subject will undergo a~     screening and assessment period (including medication washout) prior to randomization into a~     16 week double blind treatment period.~   "
210565|NCT00804557|"~     To evaluate the ease of use and comfort of a new urinary catheter, the Uro-Ease, as used in~     the Clean Intermittent Catheterization (CIC)process.~   "
210566|NCT00804544|"~     99mTc-SestaMIBI mammoscintigraphy (MMS) may be used in patients with locally advanced breast~     cancer (LABC) scheduled for neoadjuvant chemotherapy. MMS may be performed for 1) nodal~     staging of axillary lymph node metastases, 2) prediction of chemosensitivity or Pgp/MDR-1~     mediated chemoresistance, and 3) evaluation of efficacy to chemotherapy and radiation~     therapy.~      MMS is routinely performed with planar/SPECT imaging according to the Society of Nuclear~     Medicine and European Association of Nuclear Medicine guidelines.~      In this pilot study, an optimised acquisition protocol will be setup with SPECT/low-dose~     multislice CT in addition to planar imaging.~   "
210567|NCT00804531|"~     To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the~     inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on~     magnetic resonance imaging.~      Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients~     with inflammatory discopathy~   "
210568|NCT00804518|"~     The purpose of this study is to determine the effect of aerobic interval training on left-~     and right ventricular diastolic- and systolic function on healthy, sedate people over 70~     years. The old sedate cohort will be compared to young, sedate subjects also performing~     aerobic interval training and old master athletes without intervention.~   "
210569|NCT00804505|"~     The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens~     clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when~     studied:~        -  within the corresponding range of lens powers~        -  in a population randomized within multiple investigational sites~        -  with a study ration of 2/1 test vs control lenses~        -  for a duration of 90 days.~   "
210570|NCT00804492|"~     Falls, with a high prevalence, high risk and consequent medical and social costs, are an~     important issue for medical care and health promotion in the elderly. The prevalence of falls~     in the elderly lies in between 10-20%. Falls have become the second leading cause of death~     from injury for the elderly in Taiwan. A community-based study showed that, among those old~     adults after a fall, 27.3% were severely injured, 53.9% got a minor injury, and only 18.9%~     remained intact. Another study revealed that among fall injury events reported, 42% were~     hospitalized, of whom 2.2% died in hospital, and 37% entered nursing homes after discharge~     from hospital. In addition to physical discomfort, half of the elderly fallers would become~     disabled, and bring a heavy burden of social economy and family care. It was estimated that~     there were 460 thousand of old people who had a fall, and 125 thousand of them were injured~     in Taiwan, 2007. Research evidence shows that falls prevention is effective and feasible.~     Although primary falls prevention programs have been conducted at the community level and~     extended to 25 counties and cities for many years, they were not integrated with secondary~     and tertiary prevention. The study aims to establish an integrated fall prevention model,~     combined with primary, secondary and tertiary prevention. The model will be practiced in~     participating hospitals and communities, with a randomized control trial (RCT) design to~     examine its feasibility and effectiveness. Our study subjects are persons aged 65 and over~     who live in communities, go to out-patient departments (OPD) or emergency room (ER) care.~      Tasks for implementation~        1. To organize a multidisciplinary team for integrated falls prevention.~        2. To draft a guideline for falls prevention in the elderly.~        3. To set up a multidisciplinary fall clinic.~        4. To set up a falls prevention classroom.~        5. To enhance cooperate between hospitals and primary care units to fulfill the guideline~          for falls prevention in the elderly.~   "
210571|NCT00804479|"~     To determine the long-term consequences (8 years) of initiating patients with Parkinson's~     disease on either pramipexole or levodopa. We hypothesize that patients initiating therapy~     with pramipexole compared with levodopa will demonstrate less self-reported disability as~     measured by the Modified Schwab and England (S/E) scale 8 years after randomization.~   "
210953|NCT00799448|"~     This trial is conducted in Europe. The aim of this trial is to compare the efficacy and~     safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in~     type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy~   "
210572|NCT00804466|"~     Background:~        -  Cervical cancer is caused by persistent infection of the lining of the cervix with some~          kinds of human papillomaviruses (HPV). These HPV infections are distantly related to the~          viruses that cause warts on the skin. Like common wart viruses, most women who have~          cervical infections with HPV resolve the infections within 2 years without any need for~          treatment. Cervical infections that do not go away may cause disease that can turn into~          cancer after many years.~        -  Only one study has been done in Nigeria to learn how many women have HPV infection. The~          results of the study differed from most other studies in the world because older women~          were much more likely to be infected. This study with learn whether the results found in~          the previous study are true in Irun also, the site of the current study.~      Objectives:~        -  To examine the age distribution of HPV infection and relationship to cancer of the~          cervix among Nigerian women.~        -  To understand how different screening methods, including HPV testing, could best reduce~          the risk of cervical cancer in Nigerian women.~      Eligibility:~      - Women residing in Irun, Nigeria, who are 15 years of age or older.~      Design:~        -  Participants complete a brief questionnaire related to demographics, household and~          living conditions and a longer survey with questions related to reproductive history,~          family history, illnesses, stressful life events and sexual history (U. of Michigan~          collaboration).~        -  Participants have a cervical examination, HPV test, Pap test and blood test.~        -  Women whose tests show they are infected with HPV or have cervical disease will do the~          following:~        -  see a doctor and have cervical biopsies of all white abnormal areas (removal of a small~          tissue sample from the cervix)~        -  have photographs of the cervix taken~        -  have a cervical scraping for a new kind of HPV test.~        -  Some women with normal test results are also asked to see a doctor to check the validity~          of the testing~        -  Women with cervical disease receive treatment by a specialist and remain in the program~          until treatment is successfully completed or a final diagnosis is reached.~        -  Participants may be contacted for followup up to 5 years after the final diagnosis is~          made.~   "
210573|NCT00804453|"~     The primary objective is to collect data to evaluate the biocompatibility of two types of~     blood circuit, already on the market.~   "
210574|NCT00804440|"~     Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg~     Tablets, administered as a single, one-tablet dose in fasted subjects.~   "
210575|NCT00804427|"~     The purpose of this small, short pilot study is to determine the feasibility (e.g.,~     recruitment, dose acceptance, retention) of a future longer trial comparing the effects of~     two types of omega-3 fats from fish oil on plasma triglycerides. The two types of fish oil~     are composed of (1) omega-3 fatty acids in triglyceride form; and (2) as esterified free~     fatty acids (i.e. ethyl esters). Although these two types of fish oil supplements are~     available to the public, it remains unclear whether they are equally effective in lowering~     plasma triglycerides.~   "
210576|NCT00804414|"~     Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot~     ulcers.~   "
210577|NCT00804401|"~     Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets,~     administered as a 1 x 500 mg tablet under fasting conditions.~   "
210578|NCT00804388|"~     The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis~     with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head~     compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.~      The polyethylene to be used is E-Poly (Biomet).~      The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone~     loss between the two groups.~   "
210579|NCT00804375|"~     Primary: To compare the analgesic effect over 12 weeks of topical 2PX in stump pain.~      Secondary: To prospectively measure other efficacy and safety variables of topical 2PX in~     stump pain. Exploratory analyses will be performed to measure efficacy and safety variables~     of topical 2PX in phantom pain~   "
210580|NCT00804362|"~     The purpose of this study is to validate a brief survey tool, the SCD Pain Burden Interview~     (SCPBI), which can be used in the clinical and/or research settings to assess the impact of~     pain on children with sickle cell disease.~   "
210581|NCT00804349|"~     Heart Failure affects 5-6 million Americans and there are about 550 thousand new cases of~     heart failure every year. There are approximately 3 million hospital admission for acute~     decompensated heart failure with hospital readmission rate of 20% at 30 days and 50% at 60~     day, costing up to 20 billion dollars per year. In our previous study we have discovered that~     sleep disordered breathing is prevalent in 70% of patients with acute decompensated heart~     failure. We hypothesize that, detection and treatment of sleep disordered breathing in acute~     decompensated heart failure patients will reduce episodic hypoxic events during acute~     decompensation and may decrease hospital length of stay and reduce future readmissions.~   "
210582|NCT00804336|"~     The purpose of this research study is to determine the safety of the combination of SOM230~     and RAD001, as well as determine the highest dose of this combination that can be given to~     people safely. SOM230 is an investigational drug that is similar to Sandostatin LAR.~     Sandostatin is an approved drug for the use of treating symptoms of neuroendocrine tumors.~     SOM230 has shown to be effective in patients who have become resistant to Sandostatin and may~     also stop cancer cells from growing. RAD001 is an investigational drug that also may stop~     cancer cells from growing.~   "
210583|NCT00804323|"~     Argon laser trabeculoplasty (ALT) with 100 ms pulses is an effective therapy for lowering~     intraocular pressure (IOP). Similar reductions in IOP have been achieved using ns (SLT) and~     microsecond (MLT) pulses, which produce less thermal damage to trabecular meshwork (TM). Lack~     of clinically visible changes may make the accurate alignment of subsequent pulses difficult.~     We describe a novel technique - Patterned Laser Trabeculoplasty (PLT) using the PASCAL~     Photocoagulator system, and its preliminary evaluation in patients with open angle glaucoma.~   "
210584|NCT00804310|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as ixabepilone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving lapatinib together with ixabepilone may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib given~     together with ixabepilone in treating patients with advanced solid tumors.~   "
210611|NCT00803959|"~     Although no reliable and specific figures are available for the total expenditure on UDS, UDS~     is commonly performed for patients with urinary incontinence (UI) regardless of gender and~     age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are~     expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported~     insufficient evidence with which to answer the following key research questions related to~     UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do~     alterations in clinical decisions made in response to UDS results improve the clinical~     outcomes?~   "
210612|NCT00803946|"~     Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg~     Tablets, administered as a 1 x 800 mg tablet, under fed conditions.~   "
230634|NCT00537680|"~     This study is meant to assess the effectiveness of idebenone on neurological outcome measures~     in patients with Friedreich's Ataxia over a 6 months period.~   "
210585|NCT00804297|"~     Background:~      Hypoglycemia is a common presentation to the Emergency Department. Management has~     traditionally involved rapid administration of IV 50% dextrose and dextrose containing IV~     fluids in addition to oral carbohydrates. Hypoglycemic patients taking only insulin can often~     times be treated as outlined above and safely discharged to home after a period of short~     observation in the Emergency Department. This procedure is also followed in the pre-hospital~     care arena, where insulin-dependent hypoglycemic patients are often treated and released.~      In addition to diet-control and insulin, patients with diabetes maintain outpatient~     euglycemia with a class of drugs called sulfonylurea agents. This are believed to stimulate~     insulin release from pancreatic beta cells via a complex mechanism culminating in calcium~     influx and release of stored insulin from secretory granules within the pancreas. Whereas~     insulin-dependent diabetic patients are usually discharged home after establishing normal~     blood glucose levels, hospital admission is generally recommended in hypoglycemic patients~     taking oral sulfonylureas due to the long duration of effect and delayed clearance of the~     drugs and their metabolites and subsequent high likelihood of recurrent hypoglycemic~     episodes.~      Octreotide is a somatostatin analog that is known to suppress numerous hormones including~     insulin. Dextrose itself induces insulin secretion thus theoretically contributing to rebound~     hypoglycemia when used to treat hypoglycemia. Octreotide is thought to block the elevated~     insulin levels that are a result of both the sulfonlyureas and dextrose. Recent case reports~     and one prospective study in healthy volunteers have demonstrated the safety and efficacy of~     octreotide administration for the treatment of sulfonylurea induced hypoglycemia. Based~     largely on the results of these studies some experts in field of toxicology have argued that~     administration of octreotide be standard therapy for all patients with recurrent hypoglycemic~     episodes who are known to be taking sulfonylureas.~      Purpose:~      Measure the difference in serum glucose and the incidence of hypoglycemia between two groups~     of sulfonylurea-dependent patients; a control group that receives standard therapy and an~     experimental group that receives standard therapy plus octreotide.~   "
210586|NCT00804284|"~     The objective for this study is to characterize the safety profile of PENTACEL® vaccine for~     identification of potential vaccine-related adverse events not currently associated with~     PENTACEL® vaccine administration.~   "
210587|NCT00804271|"~     To validate a new Alzheimer's Disease scale against other rating tools in subjects with~     dementia of Alzheimer's type, treated with memantine.~   "
210588|NCT00804258|"~     RATIONALE: Palliative care may help improve the quality of life of patients with ovarian~     cancer who are undergoing intraperitoneal chemotherapy.~      PURPOSE: This clinical trial is studying palliative care in patients with ovarian cancer who~     are undergoing intraperitoneal chemotherapy.~   "
210589|NCT00804245|"~     RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in~     finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer.~      PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding~     metastases in patients with newly diagnosed high-risk prostate cancer.~   "
210590|NCT00804232|"~     Purpose of the study:~      To compare three different regimes for children newly diagnosed with type 1 diabetes: (1)~     traditional hospital based care, (2) intensive psychological support to the family, and (3)~     home based family psychosocial support. A further aim is to identify families were the child~     runs the risk of decreased metabolic control and to give those families increased support.~      Specific objectives:~      The main objectives of the study are:~        1. to analyse the effects on child health of family-based home care compared to traditional~          hospital-based care, and~        2. to analyse the effects on child health of family-based psychological treatment compared~          to traditional hospital-based treatment.~      The main focus will be on child health and changes in child health. Several variables will be~     collected for these purpose (see instruments, below), the main variable being the child's~     metabolic control. We will also analyse effects on the amount and content of (1) parental~     efforts (absenteeism from work; time use which is conditional on the child's diabetes etc),~     and (2) formal health care utilisation of the home-based care and psychological treatment,~     respectively, compared to traditional care.~   "
210591|NCT00804219|"~     The phenomenon of no- and low-responsiveness has been described after applications of~     different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees.~      The aim of this project is to investigate the humoral and cellular immune responses of~     low-responders after TBE vaccination in order to find parameters regarding immunoregulation~     against TBE. It is of interest if non-responsiveness is a general immunological deficit of a~     distinct patient group or if it is a antigen-specific phenomenon.~   "
210592|NCT00804206|"~     Compare the effect of an intravitreal injection of bevacizumab previous or posterior of~     panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic~     macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.~   "
210593|NCT00804193|"~     The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox~     Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference~     Product) in the treatment of subjects with tinea pedis, and to show the superiority of the~     active treatments over that of the vehicle.~   "
210594|NCT00804180|"~     The specific aim of this project is to determine the impact of this group therapy~     intervention on improving adherence, coping, and functioning among children and adolescents~     with disease processes requiring injections who experience injection-related~     anxiety.Hypotheses include:~        1. General psychosocial (quality of life) improvements from beginning to post-treatment as~          well as maintenance of these improvements 2-4 weeks following the termination of~          treatment for both youth and parents.~        2. Reduced injection-related anxiety from baseline to post-treatment as well as maintenance~          of this improvement 2-4 weeks following the end of treatment for both youth and parents.~        3. Reduced anxiety immediately following exposure to feared injection- related stimuli.~        4. For participants experiencing poor adherence to medical treatment, improvement in~          adherence as reported by both parents and youth from baseline to post-treatment as well~          as maintenance of these improvements 2-4 weeks following the end of treatment.~   "
210595|NCT00804167|"~     Describe the clinical characteristics of hypertensive patients aged of 75 years and older~     seen in general practitioner consultation according to their renal damage~   "
210613|NCT00803933|"~     Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the~     last decade, and in many places the demand largely surpasses the capacities of the treatment~     centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be~     administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There~     are currently no drugs that are easily administered and have low toxicity, and might thus be~     used as tools to support disease control.~      This study aims to compare the safety and efficacy of DB289, a new, orally administered~     dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping~     sickness. The project will be executed in the framework of an international consortium~     consisting of several partners from academia, industry and from the Democratic Republic of~     Congo Ministries of Health.~   "
210596|NCT00804154|"~     This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to~     treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a~     cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has~     relieved pain and reduced the need for pain medication in several animal experiments. It~     works by destroying nerves that transmit pain information.~      People at least 18 years of age with severe pain from advanced cancer at or below the level~     of the chest that cannot be controlled with standard treatments may be eligible for this~     study. Participants undergo the following procedures:~      Pretreatment Visit~      Before beginning treatment with RTX, patients give a medical history and undergo a physical~     examination that includes:~        -  Electrocardiogram (EKG)~        -  Blood draw~        -  Urinalysis~        -  Neurological examinations~        -  Peak expiratory flow rate (PEFR)~        -  Eye examination~        -  MRI~        -  Urology assessment~        -  Pregnancy test, when appropriate~        -  Questionnaires to collect information on health, personality, mood, pain levels and~          symptoms.~           2-Day Hospitalization~      Patients are hospitalized for 2 days for RTX injection and monitoring, as follows:~        -  RTX injection: RTX is injected in the operating room under general anesthesia. It is~          given through a catheter placed in the patient s spine. The catheter is also used to~          obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal cord.~          The fluid is examined to assess drug effects and side effects, chemical changes in the~          content of the CSF associated with RTX, and how RTX is handled by the body.~        -  Post-injection monitoring, including:~        -  Surveys about symptoms such as pain or weakness~        -  Neurological examinations~        -  Blood and CSF sampling~        -  EKG~        -  AEs~      Outpatient followup~        -  Vitals~        -  Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30 after~          the injection~        -  MRI scans of the head and back, Urology assessment and PEFR on day 15 after the~          injection~        -  Eye examination~        -  Follow-up phone calls monthly for 6 months~   "
210597|NCT00804141|"~     This is a one-year study to evaluate the long-term safety and tolerability of the~     subcutaneous (just under the skin) injection form of MOA-728 for the treatment of~     opioid-induced constipation in subjects with nonmalignant pain. The study consists of a 2~     week screening period, a 48 week open-label treatment period and a 2 week follow-up period.~     Subjects will need to agree to self-administer subcutaneous injections, complete daily~     diaries, and check-in via a daily telephone call during that year-long period.~   "
210598|NCT00804128|"~     RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose~     ductal carcinoma in situ.~      PURPOSE: This randomized clinical trial is studying contrast-enhanced MRI in women with~     ductal breast carcinoma in situ and in healthy volunteers.~   "
210599|NCT00804115|"~     Purpose: To determine the efficacy of treatment with latanoprost in combination with~     pilocarpine versus timolol or timolol/dorzolamide fixed combination (Timoptic or Cosopt) in~     eyes with XFS and elevated intraocular pressure (IOP).~      Methods: This is a randomized, open-label study to test the hypothesis that improving both~     pressure-dependent and pressure-independent aqueous outflow and minimizing iridolenticular~     friction will interfere with the progression of XFS, allow improvement in trabecular~     function, and be more effective over time than simply reducing aqueous formation.~     Randomization was performed across the centers, per patient rather than per eye to avoid any~     crossover effect caused by aqueous suppressants. Group I was treated with latanoprost and~     pilocarpine, both in the evening, and Group II with Timolol or Cosopt b.i.d. Only one eye per~     patient was randomized. Patients were followed for 2 years with assessment of IOP, visual~     field progression, tonographic outflow coefficient and trabecular pigmentation at the 6:00~     and 12:00 position.~   "
210600|NCT00804102|"~     Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced~     secretion of neurotrophic substances and direct stimulation of neurons.~   "
210601|NCT00804089|"~     The purpose of this study is to compare the therapeutic effects of acupuncture using~     traditional acupoints and Ashi points with myofascial trigger points superficial dry needling~     and acupressure, followed by postisometric stretching of the appropriate muscles, in the~     treatment of patients with chronic mechanical low back pain.~   "
210602|NCT00804076|"~     The primary purpose of this study is to examine the safety of NP2 (a nonreplicating HSV-based~     vector expressing enkephalin) in patients with cancer pain. The secondary purpose is to~     evaluate efficacy.~   "
210603|NCT00804063|"~     Glaucoma might be a mitochondria associated disease. Since citrate is a major component in~     mitochondrial metabolism its determination in blood might serve as a biomarker.~   "
210604|NCT00804050|"~     This is a prospective, randomized multicenter phase III clinical trial designed to evaluate~     the safety and activity of comparison between Erythropoietin and Erythropoietin Associated to~     Differentiating Therapy With Acid 13-Cis-Retinoic and Dihydroxyvitamin D3 in Myelodysplastic~     Syndromes Without Excess of Blasts~   "
210605|NCT00804037|"~     SUMMARY INTRODUCTION: among various treatments for patients with primary snoring, upper~     airway resistance syndrome (UARS) and obstructive sleep apnea syndrome (OSAS), the injection~     snoreplasty arose as a promising alternative in some selected cases.~      OBJECTIVE: to investigate the efficacy and tolerance of injection snoreplasty comparing~     Ethanol and Ethanolamine Oleate.~   "
210606|NCT00804024|"~     The primary goal of this registry is to collect data regarding the use of the ClearWay RX~     Local Therapeutic Infusion Catheter for all indications.~   "
210607|NCT00804011|"~     In the mechanically ventilated patient, the single greatest cause of imposed work of~     breathing is the resistance caused by the endotracheal tube. Commonly used maneuvers to~     overcome this resistance include the use of continuous positive airway pressure or pressure~     support.However, a new mode of ventilatory support called automatic tube compensation (ATC)~     delivers exactly the amount of pressure necessary to overcome the resistive load imposed by~     the endotracheal tube for the flow measured at the time (so called variable pressure~     support).~      The aim of this study is to evaluate whether a combination of pressure support with automatic~     tube compensation is superior to PS alone in weaning patients with severe neurotoxic snake~     envenoming.~   "
210608|NCT00803998|"~     The Ocular Hypertension Treatment Study is a multi-center clinical trial sponsored by the~     National Eye Institute, designed to determine the efficacy and safety of topically~     administered eye lowering medication~   "
210609|NCT00803985|"~     The purpose of this study is to se if there is a difference regarding chronic pain and sexual~     dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold~     standard open fixated on lay mesh in inguinal hernia surgery.~   "
210610|NCT00803972|"~     This is a single center, Phase I, open-label, single-blind (subjects blinded to the contents~     of each injection), 4 stage study designed to determine the PK, GD, safety, tolerability, and~     optimal ratio of rHuPH20 administered with fixed Humulin R or Humalog doses in healthy~     subjects.~   "
210614|NCT00803920|"~     The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM~     measurements gathered before starting and during treatment with exenatide IR and/or exenatide~     LAR will help determine the characteristics of glucose control during treatment.~   "
210620|NCT00803842|"~     A side effect occurring in a majority of patients taking erlotinib (Tarceva®) consists of a~     skin rash. Sometimes, symptoms associated with the rash necessitate erlotinib dose reduction~     or discontinuation. Some physicians have successfully treated the erlotinib-induced rash with~     doxycycline. At the same time, it has been observed that in patients who develop the~     erlotinib rash, the cancers respond better to erlotinib treatment. This research study is~     designed to determine how well doxycycline treats the erlotinib rash and whether doxycycline~     affects the blood levels of erlotinib.~   "
210621|NCT00803829|"~     Ulcerative colitis (UC) is one of the two main forms of inflammatory bowel disease. UC is~     associated with high morbidity and incurs significant social, commercial and NHS costs. For a~     variety of reasons, many patients are refractile to standard therapies, which often have~     undesirable side-effects. However, an inexpensive and non-toxic treatment based on the~     synbiotic concept may prove to be effective in these individuals. A synbiotic is a mixture of~     a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a~     food source for the probiotic, allowing it to grow better in the gut. The aim of this study~     is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together~     with a bifidobacterial probiotic (Bifidobacterium longum), that we have previously shown to~     reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can~     colonise the bowel, reduce mucosal inflammation, and induce remission in UC patients with~     active disease. It is planned to establish a double-blinded, controlled, randomised~     investigation involving 46 patients for six months. If the results from our pilot study can~     be reproduced and maintained in a long-term investigation, the synbiotic could become~     available very quickly, and would provide an inexpensive and effective treatment for UC,~     making a significant contribution to relieving the clinical and financial burdens of this~     disease.~   "
210622|NCT00803816|"~     Study efficacy of everolimus on course of uveitis:~        -  obtain quiescence of inflammation after start of treatment~        -  duration to obtain quiescence of inflammation~        -  number of patients with quiescence of inflammation~   "
210623|NCT00803803|"~     The purpose of this investigation, in which pilocarpine was given in repeated doses, was to~     evaluate: Part I - the effects of different concentrations of pilocarpine hydrochloride on~     intraocular pressure. Part II -the effects on intraocular pressure of glaucomatous patients~     to pilocarpine 2% when given once, twice and four daily. In addition, we studied various~     attributes of the eye which may serve as indicators of responsiveness of individual patients~     to pilocarpine.~   "
210624|NCT00803790|"~     This study will evaluate the bioequivalence of alendronate in combination with vitamin D~     compared to alendronate alone and the bioequivalence of vitamin D in combination with~     alendronate compared to vitamin D alone.~      This was an open-label, randomized, 2-part, crossover study. Each participant participated in~     one part of the study only (i.e., each participant participated only in Part I or only in~     Part II). Participants entered the study sequentially within each part of the study. A~     washout of at least 12 days separated each treatment period within each part of the study.~   "
210625|NCT00803777|"~     The purpose of this study is to evaluate the performance and acceptability of a new blood~     glucose meter.~   "
210626|NCT00803764|"~     Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets,~     administered as a 1 x 500 mg tablet under fed conditions.~   "
210627|NCT00803751|"~     This study is intended to examine the effectiveness of a new type of laryngoscope, the~     Truview EVO2, in an infant patient population. They device will be tested against the current~     clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital~     in terms of ease of use, view obtained of the vocal cords, and ability to place an~     endotracheal tube.~   "
210628|NCT00803738|"~     The objectives of this study were to demonstrate comparable safety and efficacy of~     Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories,~     80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order~     to establish bioequivalence.~   "
210629|NCT00803725|"~     The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose~     mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of~     motor blockade.~      It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will~     result in adequate surgical block for knee arthroscopy surgery with faster recovery and~     discharge compared to mepivacaine alone.~   "
210630|NCT00803712|"~     Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination~     with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism~     (SHPT) Recently Initiating Hemodialysis~   "
210631|NCT00803699|"~     In this study, we will evaluate the effectiveness of several doses of oral selenomethionine~     in raising biomarkers of selenium status including plasma selenium concentrations.~   "
210632|NCT00803686|"~     This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at~     night and to compare these results with those obtained with a placebo control and with~     commercially available nasal calcitonin.~   "
210633|NCT00803673|"~     This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in~     healthy volunteers~   "
210634|NCT00803660|"~     Multi-centre survey of type 2 diabetic patients who are currently on anti-hypertensive~     treatment. Data collection for each patient will take place at one visit. To observe the~     proportion of diabetic patients on antihypertensive treatment reaching the BP<130/80 mmHg. To~     observe the proportion of diabetic patients on antihypertensive treatment reaching the~     BP<130/80 mmHg by treatment groups. To observe the proportion of patients achieving a~     therapeutic glycemic response defined as HbA1c=<7%. To observe the proportion of patients~     achieving fasting plasma glucose<110 mg%. To identify factors for not achieving BP<130/80~     mmHg. To describe percentage of patients with positive proteinuria (including~     microalbuminuria) by treatment groups .~   "
210676|NCT00803114|"~     The investigators believe that pain management following a vaginal delivery can be improved.~     Many women receive epidural medication during labor and delivery, and the investigators felt~     that using the epidural following delivery might improve the first day pain. This study is to~     determine whether a single dose of epidural morphine given to mothers after a vaginal~     delivery will reduce the perineal pain in the postpartum period.~   "
210635|NCT00803647|"~     FC-6 is a Phase II, multi-center clinical trial for patients with unresectable, wild-type~     K-RAS, colorectal cancer with metastases confined to the liver. Liver metastases must be~     determined by FC-6 criteria to be unresectable, and the colorectal cancer (CRC) tumor~     (primary or metastatic) must be found to be wild-type K-RAS. Patients with mutant K-RAS~     tumors are ineligible. K-RAS testing can be done through the local hospital or a tumor sample~     can be submitted to the FC-6 central lab (Esoterix Clinical Trial Services).~      A primary aim of this study is to evaluate the surgical conversion rate using cytotoxic~     combination chemotherapy and biologic therapy with cetuximab, a monoclonal antibody targeted~     against the epidermal growth factor receptor. A second primary aim is to evaluate the safety~     and tolerability of a chemotherapy/targeted therapy regimen in this patient population.~     Secondary aims include determination of clinical response rate, recurrence-free survival for~     patients undergoing complete resection and/or ablation of liver metastases, and overall~     survival.~   "
210636|NCT00803634|"~     The purpose of this study was to evaluate the efficacy and safety of intravenous (IV)~     clevidipine as compared with standard of care IV antihypertensive agents for blood pressure~     (BP) lowering in patients with acute heart failure and elevated BP.~   "
210637|NCT00803621|"~     With a HIV incidence much higher in the DFA than in European French territory, this disease~     is a major public health problem in these areas, especially in French Guiana.~      Cerebral toxoplasmosis is a priority among the opportunistic infections in AIDS patients from~     the DFA because of its frequency (French West Indies) and of its lethality (French Guiana).~      The diagnosis of cerebral toxoplasmosis may be difficult because based only on presumptive~     clinical and radiological features. The response to specific antitoxoplasmic therapy confirms~     a posteriori the diagnosis.~      In reference to the data collected by the Biological Resource Centre Toxoplasma, in~     particular in French Guiana, we think that T. gondii strains reactivating in AIDS patients~     from DFA are genetically different from those reactivating in AIDS patients from Europe, with~     an increased capacity for dissemination via peripheral blood in the first ones. This more~     frequent or more prolonged parasitemia could facilitate the diagnosis of cerebral~     toxoplasmosis by PCR test from peripheral blood samples in AIDS patients from the French~     departments of America.~   "
210638|NCT00803608|"~     To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in~     recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of~     consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least~     one recently healed plantar MTH foot ulcer (>1 week but <12 weeks since heeling) and have~     Loss of Protective Sensation.~   "
210639|NCT00803595|"~     The primary objective of this study is to confirm the efficacy of CS-8958 administered as a~     single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir~     phosphate using the time to alleviation of influenza illness. For safety evaluation,~     between-group comparisons will be made with regard to incidence of adverse events and other~     safety measures.~      In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated~     based on the efficacy and safety of single inhaled low or high dose.~   "
210640|NCT00803582|"~     The purpose of this study is to investigate the efficacy of acupuncture for the treatment of~     phonotraumatic lesions of the vocal folds, using the International Classification of~     Functioning Disability and Health (World Health Organization, 2001) as the conceptual~     framework to guide the selection of outcome measures.~   "
210641|NCT00803569|"~     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective~     immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating~     patients with stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube~     cancer, or primary peritoneal cavity cancer.~   "
210642|NCT00803556|"~     To determine the Maximally Tolerable Dose (MTD) of KOS-1022 when administered weekly in~     combination with trastuzumab or in combination with trastuzumab and paclitaxel to patients~     with advanced solid tumor malignancies~   "
210643|NCT00803543|"~     The purpose of the study is to determine how common herpes is among persons with HIV who do~     not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in~     the blood, and the amount of HSV in bodily secretions.~   "
210644|NCT00803530|"~     This is a prospective, multicenter phase II trial designed to evaluate the safety and~     activity of the combination of association of arsenic trioxide (ATO) and ascorbic acid in~     patients with myelodysplastic syndromes~   "
210645|NCT00803517|"~     This study is a comparison of multifocal electroretinogram assessment between the laser~     treatment group and the photodynamic therapy group in chronic central serous~     chorioretinopathy.~   "
210646|NCT00803504|"~     Glaucoma is one of the most common causes of blindness in the industrialized nations. For a~     long time glaucoma has been defined as a disease in which high intraocular pressure (IOP)~     leads to irreversible optic disc damage and subsequent visual field loss. However, recent~     investigations show that IOP is not the only factor that is involved in the glaucomatous~     process leading to retinal ganglion cell death. The role of vascular factors in the~     pathogenesis of glaucoma has recently received much attention based on animal experiments and~     epidemiological studies. It is, however, assumed that vascular factors do not contribute to~     same degree in all glaucoma patients. Generally, it is believed that a vascular component is~     more important in normal tension glaucoma patients and patients with underlying~     cardiovascular disease. Little is, however, known about a potential association between optic~     nerve head morphology and ocular perfusion in POAG patients. The current study seeks to gain~     insight into this association by assessing ocular blood flow parameters with a number of~     noninvasive technologies.~   "
210647|NCT00803491|"~     Randomized controlled trial including 200 subjects with rheumatic diseases. Subjects will be~     randomized to either a self-promoting problem based learning (PBL) program or a control group~     with traditional care. The hypothesis is that a PBL program will improve health-related~     quality of life, empowerment and self-care ability.~   "
210677|NCT00803101|"~     The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N~     (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin~     K antagonists in subjects who require immediate correction of international normalized ratio~     (INR) because of emergency surgery.~   "
210648|NCT00803478|"~     Corneal sensation is known to play a role in tear secretion. Decreased sensation leads to~     decreased tear production; and when bilateral, leads to a decreased blink rate as well. Dry~     eyes are a common side effect of LASIK. Incidence rates vary widely, but have been reported~     in as many as 59% of patients. And almost all patients have some transient dry eye symptoms~     immediately following LASIK.~      Previous studies have looked at the effect of hinge position (superior vs. nasal) and hinge~     width on corneal sensation and dry eye after LASIK performed with a mechanical microkeratome.~     Corneal sensation was decreased and dry eye signs and symptoms increased immediately~     following LASIK in all eyes. These parameters then improved at all time periods between 1~     week and 6 months post-operative. Loss of corneal sensation and dry eye signs and symptoms~     were greater in eyes with superior-hinge flap than nasal-hinge flap, and in eyes with~     narrower hinge flap rather than wider hinge flap IntraLase LASIK, using the IntraLase~     femtosecond laser rather than a mechanical microkeratome to cut the corneal flap, has become~     an increasingly popular procedure. It provides several advantages over mechanical~     microkeratomes, including reduced surgical complications, more predictable flap thickness,~     better astigmatic neutrality, decreased epithelial injury, and an ability to operate on a~     wider range of patients.~      The investigators propose this study to evaluate the effect of flap hinge size and flap~     thickness in corneal flaps created with the IntraLase laser. The investigators would like to~     determine if there is a difference from the previously discussed results found when using the~     mechanical microkeratome. Also, with the increased ease of programming alternate hinge width~     or flap thickness with IntraLase, if the investigators find a significant difference with an~     alternate flap configuration, it might translate to a feasible change in clinical practice.~   "
210649|NCT00803465|"~     The purpose of this study was to compare the relative vasoconstrictive effects of test and~     reference topical Fluticasone Propionate 0.05% Cream in healthy, female subjects.~   "
210650|NCT00803452|"~     This prospective, randomized, comparative clinical trial evaluates the effect of either oral~     doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of~     the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.~   "
210651|NCT00803439|"~     The purpose of this study was to compare the relative vasoconstrictive effects of test and~     reference Clobetasol Propionate 0.05% Topical Foam in healthy, female subjects.~   "
210652|NCT00803426|"~     Sciatic nerve block is used routinely in ankle and foot surgery. It is applied often by a~     posterior approach at the popliteal fossa, near where the nerve divides into the common~     peroneal and tibial nerves. Due to the size of the sciatic nerve, the largest in the body,~     infiltration of anesthetic and onset of anesthesia can take a significant amount of time.~     This study hypothesizes that selectively blocking both the common peroneal and the tibial~     nerves distal to the bifurcation may result in a faster block onset than blockade of the~     sciatic nerve proximal to its bifurcation.~   "
210653|NCT00803413|"~     Do Back School and/or supervised walking improve reported pain and spine flexibility in~     sedentary women with chronic low back pain (LBP)?~   "
210654|NCT00803400|"~     The purpose of this study is to determine whether the combination of aerobic physical~     exercise and alprazolam in patients with panic disorder has a better therapeutic response~     than the treatment with alprazolam alone.~   "
210655|NCT00803387|"~     Although Benzalkonium chloride (BAC) has been used as a preservative for many years, many~     studies have demonstrated that prolonged use of topical ocular medications preserved with BAC~     may exacerbate sequelae associated with ocular surface disease. These effects could lead to~     the induction of subclinical inflammation,1 reduction of corneal epithelial barrier function,~     2, 3 destabilization of the tear film, 4 cataract formation, 5 and an overall higher~     incidence of patient complaints of dryness and irritation. 4-6 This study will compare the~     efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed~     formulation of latanoprost 0.005%with BAC in patients with dryness and irritation and~     open-angle glaucoma or ocular hypertension. A double blind comparison will be used to assess~     whether those two different formulations will affect the tear breakup times, corneal~     staining, and baseline tear secretion tests in patients that are already taking latanoprost~     regularly with complaints of dryness and irritation. Patients included in the study will be~     given two bottles, one labeled for their right eye and the other for their left eye. Each~     pair of bottles will be identical in appearance and randomized with either latanoprost or~     travoprost and each pair will be assigned a number to aid in future analysis of the final~     results.~   "
210656|NCT00803374|"~     The purpose of this study is to determine if BMS-663513 administered in combination with~     ipilimumab to patients with advanced malignant melanoma is safe and tolerable~   "
210657|NCT00803361|"~     This is a 15 week study comparing how well duloxetine and placebo treatments improve~     generalized anxiety disorder~   "
210658|NCT00803348|"~     Patients undergoing total knee arthroscopy (knee replacement) surgery usually receive a~     femoral nerve block as part of their anesthetic care. Some centers administer the block with~     a single shot of local anesthetic, which wears off several hours after surgery. Other centers~     administer the block with a single shot followed by continuous infusion of local anesthetic,~     typically for 2 to 5 days after surgery. The latter method, though good for pain control, may~     result in decreased mobility (while the anesthetic is still active), longer hospital stays,~     and greater risk of falls.~      This study will see if using a lower concentration of local anesthetic for the continuous~     femoral nerve block or only the initial single-shot dose will result in increased mobility~     and shorter hospital stays.~   "
210659|NCT00803335|"~     The purpose of this study is to find out how long it takes the vagina to respond to hormonal~     vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address~     the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.~   "
210660|NCT00803322|"~     The purpose of this study is to see if involving community health workers improves~     tuberculosis case finding and treatment outcome.~   "
210661|NCT00803309|"~     In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having~     characteristics associated with poor treatment response for additional 12 or 24 weeks beyond~     the standard treatment of PEG-IFN alpha-2b plus ribavirin.~      The objective of this study is to compare the efficacy of a treatment extension of 12 versus~     24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN~     alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who~     are not HCV-RNA negative (< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA~     negative after 16-24 weeks of standard treatment.~   "
210678|NCT00803088|"~     The objective of this multicenter, single-arm, open-label clinical study is to evaluate the~     safety of performing bronchial thermoplasty with the Alair® System during two treatment~     sessions to treat severe asthma.~   "
210679|NCT00803075|"~     The purpose of this study is to determine if it is safe and effective to use the TALENT AAA~     Stent Graft System as a treatment for AAAs in patients who are also candidates for~     conventional surgical aneurysm repair.~   "
210662|NCT00803296|"~     The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the~     notion that this deficiency is a consequence of the diabetic state. However, the impact of~     insulin resistance on the incretin effect in obese individuals who uphold a normal glucose~     tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary~     aim of the present study is to evaluate the separate impact of one of the cornerstones of~     type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean~     and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of~     healthy control subjects.~   "
210663|NCT00803283|"~     The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral~     System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR)~     in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.~   "
210664|NCT00803270|"~     The purpose of this study is to compare treatment outcomes for patients with mixed urinary~     incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is~     initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and~     urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery~     for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up~     will be a minimum of 12 Months.~   "
210665|NCT00803257|"~     Symptoms of CTS occur when any condition decreases the size of the carpal canal or increases~     the volume of the structures within the carpal canal, compressing the median nerve. One cause~     of the symptoms of CTS is the incursion of the lumbrical muscles of the hand into the carpal~     canal. Individuals with CTS tend to have tight lumbrical muscles which increase this~     incursion, thereby increasing CTS symptoms. An intervention designed to reduce the incursion~     of the lumbrical muscles should have an effect on the symptoms of CTS.~      The purpose of this study is to systematically examine the effect of an intensive lumbrical~     muscle intervention, splinting to prevent lumbrical muscle incursion and lumbrical muscle~     exercises, on the symptoms of CTS. This project will be a randomized clinical trial to~     evaluate the effectiveness of a home program targeting the lumbrical muscles. One hundred and~     twenty subjects will be assigned to one of 4 groups: Group 1 will receive a home program of~     lumbrical muscle stretches combined with a lumbrical positioning splint; Group 2 will receive~     a home program of lumbrical muscle stretches combined with a night wrist cock-up splint;~     Group 3 will receive a home program of general stretches combined with a lumbrical~     positioning splint; and Group 4 will receive a home program of general stretches combined~     with a night wrist cock-up splint. After 1 month, 3 months, and 6 months the groups will be~     compared to determine if there is a significant reduction in symptoms between the groups.~   "
210666|NCT00803244|"~     The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of~     grass pollen allergen extract when initiated 2 months before the grass pollen season compared~     with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.~   "
210667|NCT00803231|"~     The transparency commission wishes that the laboratory Lilly France sets up a follow-up study~     describing the conditions of use of Xigris® in France.~      The purpose of this study is to describe the characteristics of the treated patients, the~     conditions of drug use, in particular the conditions of treatment initiation and the clinical~     development of the patients during normal clinical practice, in particular rate and cause of~     mortality within one month.~   "
210668|NCT00803218|"~     The purpose of this study was to compare the relative vasoconstrictive effects of test and~     reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.~   "
210669|NCT00803205|"~     Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the~     cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of~     mutation called a nonsense (premature stop codon) mutation is the cause of CF in~     approximately 10% of subjects with the disease. Ataluren (PTC124) is an orally delivered~     investigational drug that has the potential to overcome the effects of the nonsense mutation.~     This study is a Phase 3 trial that will evaluate the clinical benefit of ataluren (PTC124) in~     adult and pediatric patients with CF due to a nonsense mutation. The main goals of the study~     are to understand whether ataluren (PTC124) can improve pulmonary function and whether the~     drug can safely be given for a long period of time. The study will also assess the effects of~     ataluren on CF pulmonary exacerbation frequency, cough frequency, health-related quality of~     life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body~     weight, and CF pathophysiology. Funding Source - FDA OOPD~   "
210670|NCT00803192|"~     Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40~     mg tablet under fed conditions.~   "
210671|NCT00803179|"~     Our hypothesis is that Growth Hormone (GH) will not only target the peripheral tissue to~     stimulate weight and muscle growth which will maximize nutritional potential and improve~     overall quality of life. We theorize that this will occur through a multitude of factors:~     increased appetite, more constructive utilization of caloric intake and decreased catabolic~     signaling. The first aim will address changes in weight and lean body mass following the~     institution of GH therapy in adults with Cystic Fibrosis (CF) related wasting. The second aim~     will measure impact on quality of life of these individuals. Additionally, the third aim will~     monitor effects of GH therapy on diabetes and insulin sensitivity. Finally, the fourth aim~     will observe changes in the subjects underlying diagnosis of CF, specifically lung function,~     muscle strength and inflammatory state.~   "
210672|NCT00803166|"~     The purpose of this study was to compare the relative vasoconstrictive effects of two test~     and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.~   "
210673|NCT00803153|"~     To report the safety and incidence of adverse effects, during and after a successful~     photocoagulation for different pathologies using a Pattern Scan Laser (PASCAL) system and its~     modified settings~   "
210674|NCT00803140|"~     Cutaneous scarring after elective surgery is a concern for surgeons of all types, perhaps~     even more so to plastic surgeons. Cautery is often used on the cut setting to make or~     extend incisions; however very few studies have looked at the results of these scars. The~     investigators' study aims are to compare standard scalpel incisions versus cautery incisions~     and to objectively compare the resultant scars in a prospective, randomized, controlled~     fashion.~   "
210698|NCT00802828|"~     Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40~     mg tablet under fasting conditions.~   "
210680|NCT00803062|"~     This randomized phase III trial studies the side effects of paclitaxel when given together~     with cisplatin or topotecan with or without bevacizumab and to compare how well they work in~     treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs~     used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere~     with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is~     more effective when given together with cisplatin or topotecan with or without bevacizumab in~     treating patients with cervical cancer.~   "
210681|NCT00803049|"~     The primary objective of this study was to document the long-term safety and tolerability of~     teriflunomide in Multiple Sclerosis (MS) participants with relapse.~      The secondary objective was to document the long-term efficacy on disability progression,~     relapse rate and Magnetic Resonance Imaging (MRI) parameters.~   "
210682|NCT00803036|"~     Since the primary damage from traumatic brain injury (TBI) is irreversible, the focus of~     medical management of TBI is preventing secondary injury that can be life-threatening and~     worsen patient outcome. Insight into the pathologic mechanisms of secondary injury, which are~     largely unknown, is required for developing better treatments.~      In preliminary studies, the investigators have found that a pathologic brain activity, known~     as spreading depression, recurs in a large number of TBI patients in the first week after~     injury. Spreading depressions are short-circuits of brain function that arise spontaneously~     from an injury and spread repeatedly as waves into neighboring brain tissue. Animal research~     has shown that spreading depressions can cause secondary injury to the brain.~      The primary objective of this observational study is to determine whether the occurrence or~     severity of spreading depression is related to worse neurologic recovery from TBI. Results~     from the study will determine whether monitoring of spreading depression should be used as a~     guide or target for improved medical management of the TBI patient.~   "
210683|NCT00803023|"~     To compare the safety and tolerability of sodium oxybate given as a combination of an oral~     solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).~   "
210684|NCT00803010|"~     The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to~     Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease.~     Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell~     transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone~     marrow and blood cells that come from someone other than the patient (a donor).~   "
210685|NCT00802997|"~     to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region~     using the sinergy system by comparing a treatment group to a placebo group~   "
210686|NCT00802984|"~     The purpose of this study is to determine whether the system is safe and effective for the~     intended use of treating descending thoracic aortic aneurysms.~   "
210687|NCT00802971|"~     Idiopathic reactive hypoglycemia (IRH) describes a condition where recurrent episodes of~     symptomatic hypoglycemia occurs one to four hours after a meal, usually following meals rich~     in carbohydrates. Differential diagnoses to be excluded include those caused by isulinomas or~     bariatric surgery (dumping syndrome), or iatrogenic induced hypoglycaemia.~      The prevalence of IRH is not fully known. A British trial among 1136 random chosen women aged~     17-50, reported that 37.9% experienced symptomatic hypoglycemia four times every month (mean~     value). However, not all reported symptoms attributed to a low blood glucose (BG) correlates~     with measured low levels of BG and a true hypoglycaemic episode, i.e., as defined by~     American Diabetes Association (ADA) when plasma BG value is < 3,9 mmol/l with or without~     accompanying symptoms. This was underscored in three studies from England, Canada and~     Denmark, in whom all reported hypoglycaemic symptoms, but in whom accompanying plasma glucose~     values < 3,3 mmol/l during hypoglycaemic symptoms only occurred in 23, 47 and 0% of the study~     subjects, respectively. The majority of those with symptoms related to IRH hence are having~     these symptoms without being classified as hypoglycemic according to conventional~     interpretations. However, a new (2005) ADA definition; relative hypoglycemia, also comprise~     these symptomatic cases of hypoglycemia following a plasma glucose > 3,9 mmol/l.~      Hormonal and cerebral mechanisms tightly control the complex interplay of mechanisms involved~     in regulating BG concentration. Explanations for IRH are centralized around increased insulin~     secretion/sensitivity and/or down regulated transcription of glucagon receptor or reduced~     glucagons sensitivity- and secretion. Others assess an overabundance of adrenaline and~     cortisol, witch is excreted at the nadir of the BS curve (venous plasma glucose between 3.6~     and 3.9). The latter event, during which typical symptoms is characterized of anxiety,~     fatigue, irritability, palpitations, nervousness, tachycardia, tremor and sweat.~      Today, treatment is limited to dietary recommendations of eating frequent meals of moderate~     size, reasonably high in protein, and with a low glycaemic load. These advices keep cerebral~     glucose concentration stable and prohibit neuroglycopenic symptoms like hunger, dizziness,~     tingling, blurred vision, difficulty in thinking, and faintness. Pharmacologic attempts in~     treating IRH involves diazoxide, metformin, α-glucosidase inhibitor, glitazones and~     somatostatin, however, none of these medications are specifically indicated for the~     condition.~      Fiber is a class of carbohydrate resistant to hydrolytic digestion in the upper bowel but~     fermented in the colon by bacterially produced enzymes. It makes the rate of ventricular~     emptying increase and prolongs the bowel transit time; thus having a minimal impact on BG~     values. Inulin and oligofructose are composed of polymers of oligofructose having~     characteristic features different from other fibers because of their physiological and~     biochemical attributes. Found in a variety of edible fruit and vegetables, their fermentation~     produces short-chain fatty acids that acidify the colonic content. This stimulates~     selectively the growth of beneficial and potentially health-promoting bifidobacteria and~     reduces potential harmful colon bacteria. Acting as prebiotica, oligofructose induces changes~     in the colonic epithelium and in miscellaneous colonic functions, inter alia, enhances~     calcium and magnesium absorption, modulates endocrine as well as immune functions and affects~     the metabolism of lipids positively. The latter, being at a systemic level, may contribute to~     modulating lipogenesis and reducing triglyceridemia by partially impairing hepatic~     cholesterol synthesis.~      FOS has not yet been investigated thoroughly as a possible stabilizer of blood glucose.~     However, several non-oligofructose studies, using a high-fiber diet, indicates reduced~     pre-prandial BG values, less hypoglycemic cases, glukosuri, total cholesterol, triglycerides,~     VLDL cholesterol and area under the curve (AUC) in a 24 hours measurement (every 2 hour) of~     BG and insulin concentration.~      Clinical evaluation of safety of inulin and oligofruktose as dietary fiber has reported 20~     g/day of oligofructose to be well tolerated. The various GI side effects identified include~     abdominal pain and bloating, flatulence and osmotic diarrhea.~      Despite the fact that fiber intake is proven inversely related to hypoglycemic events,~     possible benefits of daily FOS-supplementation have not yet been investigated systematically~     in persons suffering of IRH. Given the estimated high prevalence of IRH it is in our aim to:~        1. Study the prevalence and characteristics of subjects with IRH in a relevant Norwegian~          study population of 414 study participants.~        2. Evaluating the effect of FOS supplementation on blood glucose variability.~   "
210688|NCT00802958|"~     The purpose of this study was to compare the relative vasoconstrictive effects of test and~     reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.~   "
210689|NCT00802945|"~     This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients~     with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based~     treatment in the metastatic setting.~      Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered~     at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d~     schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may~     be evaluated in this study with approximately 35 patients enrolled in each treatment arm.~   "
210690|NCT00802932|"~     The purpose of this study is to test metallic markers in the breast tissue after breast~     conserving surgery and to observe the metallic markers' stability in the breast for use as~     tumor bed markers and positioning devices for radiation treatment.~   "
210691|NCT00802919|"~     This is a 8-week double-blind placebo controlled parallel group study of the efficacy of~     varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on~     cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures~     is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a)~     measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes.~     Subjects will be current cigarette smokers or history of regular smokers.~   "
210692|NCT00802906|"~     The purpose of this study is to evaluate the clinical efficacy of an initial subthreshold~     retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection~     in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE~     to induce reproliferation of healthy RPE cells, whereas the intravitreal injection should~     non-selectively stop the RPE leakage.~   "
210693|NCT00802893|"~     This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4~     to improve endothelial function, reduce systolic blood pressure and reduce arterial~     stiffness.~   "
210694|NCT00802880|"~     The purpose of this study is to determine the overall best tumor response rate to dacarbazine~     given until disease progression as assessed by RECIST criteria, CT and clinical exams in~     patients with metastatic sarcomas.~   "
210695|NCT00802867|"~     Objectives:~        -  To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered~          to children 4 to 6 years of age who have previously received four doses of PENTACEL™~          vaccine.~        -  To present immunogenicity before and after a single dose of DAPTACEL® vaccine~          administered to children 4 to 6 years of age who have previously received four doses of~          PENTACEL™ vaccine.~   "
210696|NCT00802854|"~     The objective of this study is to collect the safety and efficacy data of Eraxis IV~     (anidulafungin) 100 mg according to Korea Ministry of Food and Drug Safety regulations.~   "
210697|NCT00802841|"~     There is no available data on the clinical benefit of dose escalation for patients with~     suboptimal response to imatinib, and patients may still improve their response with~     continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of~     follow-up. However, there is no data yet regarding the potential benefit of using nilotinib~     in the group of patients with suboptimal response. In this study, the efficacy of nilotinib~     400mg BID will be compared to imatinib 600mg QD.~   "
210699|NCT00802815|"~     Inclusion body myositis (IBM) is the most common late onset acquired muscle disease. Patients~     develop progressive weakness that may result in the need for assistive devices including a~     wheelchair. IBM may be due to abnormal immune activation, due in part to overproduction of~     tumor necrosis factor (TNF)-alpha. Etanercept blocks the activity of TNF-alpha, thereby~     blunting immune overactivation. Previous unblinded studies and case reports suggest that~     etanercept may improve strength or slow the progressive weakness in IBM. We are conducting a~     double-blind, randomized, placebo-controlled study to test if Etanercept is beneficial in~     slowing the progressive weakness in patients with IBM.~   "
210700|NCT00802802|"~     Efavirenz (EFV) is an anti-HIV medicine that is commonly used to treat HIV infection in~     adults and children older than 3 years of age. This study is being conducted to look at the~     safety of EFV, blood levels of EFV, genetic factors that may affect blood levels of EFV, and~     how easy it is for infants and young children to take and tolerate EFV. This information will~     help recommend the best doses of EFV for children younger than 3 years of age.~   "
210701|NCT00802789|"~     Treatment of patients insufficiently treated with ICS or ICS + LABA.~   "
210702|NCT00802776|"~     Penetrating keratoplasty (PKP) is corneal transplantation performed by using round trephine~     blades to create matched circumferential incisions in both the diseased cornea and the donor~     cornea. The donor tissue graft is then secured in place with sutures which are usually~     removed postoperatively.The primary surgical goals are the preservation of a clear graft and~     improvement of vision. Surgical outcomes are limited by donor-recipient junction mismatch,~     astigmatism, rejection, infection and wound dehiscence.~      The femtosecond laser is a focusable, infrared laser capable of cutting tissue at various~     depths and in a range of patterns, and is currently being used to create corneal lamellar~     flaps in LASIK surgery. The laser parameters can be adjusted for submicron precision in~     cutting desired diameters, depths and shapes in the cornea, with minimal collateral injury.~     This technology is now capable of creating full-thickness corneal trephinations with~     customized locking edges at the graft-host junction between the donor and recipient corneas~     in Femtosecond Laser-Assisted Keratoplasty (FLAK). This approach may allow for better wound~     junction of the donor and recipient corneas, which in turn may also significantly reduce~     astigmatism, improve wound healing and visual recovery.~      This pilot study will help us determine optimal femtosecond laser spot size, separation,~     fluence, and energy which result in the best graft-host fit.~      The specific aim is to investigate postoperative physiology and biomechanics after FLAK in~     human eyes.~   "
210703|NCT00802763|"~     This study was designed to validate the color appearance on the newly developed panty liner~     (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into~     contact with vaginal secretion with an elevated pH level, without false positives due to~     urine remains or incontinence. The study will also asses the physical comfort in using~     NORMA-SENSE and the result reading clarity which includes the ability to visualize and~     interpret the NORMA-SENSE strip results.~   "
210704|NCT00802737|"~     The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment~     and maintenance in patients with chronic lymphocytic leukemia who have previously responded~     or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).~   "
210705|NCT00802724|"~     The primary purpose of this proposal is to conduct a prospective, randomized, controlled~     clinical trial to examine whether or not treatment based on a person's direction-specific,~     impairment-based LBP classification is more effective than Non-specific treatment in~     improving short- (6 weeks) and long-term (6 and 12 months) outcomes in people with chronic~     LBP. We hypothesize that treatment based on a person's direction-specific, impairment-based~     LBP classification (Classification-specific) will result in better outcomes than Non-specific~     treatment. Our approach to classification-directed treatment is based on the proposal that a~     person's LBP is the result of adopting direction-specific strategies of movement and~     alignment of the spine which then are used repeatedly during the person's everyday~     activities. The exposure of spine tissue to repeated loading in the same direction across a~     day is proposed to accelerate the accumulation of stress, microtrauma, and eventually LBP. We~     also hypothesize that until the factors contributing to the use of the direction-specific~     strategies of the spine are modified, the LBP problem will persist or recur. Identification~     of homogeneous subgroups of people with LBP will enhance 1) the power of clinical trials, 2)~     prognosis, and 3) the ability to identify mechanisms contributing to different LBP problems.~   "
210706|NCT00802711|"~     RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy,~     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and~     cause less damage to normal tissue. Internal radiation uses radioactive material placed~     directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may~     kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional~     conformal radiation therapy is more effective than internal radiation therapy when given~     after surgery in treating early-stage breast cancer.~      PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy~     to see how well it works compared with internal radiation therapy when given after~     breast-conserving surgery in treating women with stage I or stage II breast cancer.~   "
210707|NCT00802698|"~     The purpose of this study is to describe the effect of transcorneal electrical stimulation~     (TES) with a non conventional biphasic bipolar waveform in central retinal artery occlusion~   "
210737|NCT00802308|"~     The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when~     administered with alcohol and compare to administration with water.~   "
210749|NCT00802152|"~     In-home health monitoring devices have the potential to increase the speed and ease of~     modifying treatment for ambulatory patients living with chronic conditions. This study~     examines the implementation and effectiveness of remote data transmission from in-home~     devices (blood glucose meter/blood pressure machine) to the clinic on treatment outcomes in~     patients with diabetes who have out of range blood glucose (BG) or systolic blood pressure~     (BP) measurements. We test whether the short-term targeted use of in-home monitoring devices~     facilitates management for providers and improves outcome measures for patients.~   "
210750|NCT00802139|"~     multi-center, prospective, randomized, open-labeled, active-drug-controlled,~     two-parallel-group-comparison(venoferrun group vs Bolgre group)study~   "
210708|NCT00802685|"~     The investigators propose the present study with the following aims:~        -  to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen~          treatment at the onset of clinical symptoms is superior to late ibuprofen treatment only~          when symptoms of a hemodynamically significant PDA are present in the evolution of~          bronchopulmonary dysplasia (BPD) defined as duration of supplemental oxygen exposure~          during the first 28 days~        -  to determine whether early PDA treatment with ibuprofen will be superior to late~          treatment with ibuprofen in efficacy of PDA closure, need for rescue therapy, need for~          PDA ligation and incidence of major complications of prematurity.~      Hypothesis: Early pharmacologic closure of PDA with ibuprofen will improve respiratory course~     and reduce BPD as reflected by a reduction in duration of supplemental oxygen during the~     first 28 days of age vs. late pharmacologic treatment with ibuprofen.~      Outcome variables: The primary outcome of this study is the number of days spent on~     supplemental oxygen by each infant during the first 28 days.~      Other outcomes to be determined between groups include:~        -  Mortality~        -  Other respiratory variables: total days on supplemental oxygen, days on mechanical~          ventilation, oxygen dependence at 36 weeks post menstrual age, age at final extubation.~        -  Other respiratory complications: pneumothorax, pulmonary interstitial emphysema, need~          for high frequency ventilation, pulmonary hypertension~        -  Efficacy of PDA closure: number of courses of medication required, need for ligation~        -  Other neonatal complications: intraventricular hemorrhage (IVH), periventricular~          leukomalacia (PVL), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC),~          intestinal perforation, sepsis, renal dysfunction (oliguria, elevated creatinine)~        -  Time to achieving full enteral feedings, time to regain birth weight, weight at~          discharge.~        -  Length of hospital stay~   "
210709|NCT00802672|"~     The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox~     Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment~     of subjects with tinea pedis, and to show the superiority of the active treatments over that~     of the vehicle.~   "
210710|NCT00802659|"~     This study will evaluate pain control and quality of life in patients with paraspinal~     metastases, who have receive previous radiation therapy to these lesions, using single dose~     stereotactic radiotherapy.~   "
210711|NCT00802646|"~     The purpose of this study is to determine if the epidural of local anesthetics has an effect~     on fever that may occur in first time mothers during labor.~   "
210712|NCT00802633|"~     Evaluate the utility/safety of an FDA-approved tissue sealing device during radical~     cystectomy as compared to an FDA-approved stapling device.~   "
210713|NCT00802620|"~     The purpose of this study is to compare amniotic membrane associated with conjunctival~     autograft versus conjunctival autograft alone in the treatment of recurrent pterygia.~   "
210714|NCT00802607|"~     This study will collect bone, cartilage, tendon, ligament, skin and fat tissue from patients~     undergoing surgery at Children's National Medical Center in Washington,~   "
210715|NCT00802594|"~     Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the~     last decade, and in many places the demand largely surpasses the capacities of the treatment~     centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be~     administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There~     are currently no drugs which might be used as a tool to support disease control that is~     easily administered and has low toxicity.~      This study aims to assess the efficacy of DB289, a new, oral drug for treatment of first~     stage sleeping sickness. The project will be executed in the framework of an international~     consortium consisting of more than a dozen partners from academia, industry, and the~     Ministries of Health of Angola and the Democratic Republic of Congo.~   "
210716|NCT00802581|"~     Current practices when performing any peripheral nerve block may or may not involve ensuring~     circumferential spread of local anesthetic around the nerve. Ensuring circumferential spread~     can involve several redirections of the needle above and below the nerve, and potentially~     could result in either more discomfort for the patient or an increased chance of inadvertent~     direct trauma to the nerve. Not ensuring spread around the nerve may result in a slower and~     less complete blockade. The investigators suspect that by ensuring complete spread around the~     nerve, the speed of block onset would be quicker because it avoids the loss due to diffusion~     time.~   "
210717|NCT00802568|"~     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop~     the growth of cancer cells. It also stops the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune cells and help~     destroy any remaining cancer cells (graft-versus-tumor effect).~      PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with~     busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how~     well it works in treating patients with multiple myeloma that has not responded to treatment.~   "
210718|NCT00802555|"~     Multi-center, single-arm Phase 1b study designed to evaluate safety and tolerability of ARQ~     197 in cirrhotic patients with HCC.~   "
210719|NCT00802542|"~     The purpose of this study is to prove in practice the effectiveness of Atacand 16 mg in~     reducing blood pressure after 4 weeks of administration and the importance of administration~     of adequate doses~   "
210720|NCT00802529|"~     This trial aims to compare transtympanic steroids against the standard treatment~     (transtympanic gentamicin) in refractory unilateral Meniere's disease.~   "
210721|NCT00802516|"~     BACKGROUND Plant sterols and stanols are compounds that are structurally related to~     cholesterol, which decrease intestinal cholesterol absorption and consequently serum LDL~     cholesterol concentrations by 10-14%. Nowadays plant sterols and stanols are widely available~     incorporated in food products like margarines and yogurts and are presented as functional~     foods.~      Whether the cholesterol lowering effects of plant sterols and stanols also favorably affect~     endothelial function in humans is currently unknown. Apart from their cholesterol lowering~     effects, plant sterols and stanols might have other effects like effects on red blood cell~     properties, cognitive performance and antioxidant status. Especially to evaluate effects on~     this type of parameters long-term daily consumption of plant sterols and stanols is~     necessary. These questions will be answered in statin treated patients since functional foods~     enriched with plant sterol and stanol esters have been recommended for statin-users as an~     add on therapy. This may ultimately lead to a lower dose of statins or an increased number~     of patients that reach the target for LDL-cholesterol reduction.~      AIM The major objective of the present proposal is to examine the effects of a long-term~     consumption of plant sterols and stanols on the endothelial function of the vessel wall in~     statin-treated patients.~      STUDY DESIGN Subjects: The subjects will be recruited among men and women in Maastricht and~     surroundings, aged between 18 and 70 years. Participation will be on voluntary basis. People~     who are willing to participate will be invited for two screening visits.~      Experimental design: The present study is a double-blind, randomized parallel intervention~     trial with 60 statin-treated subjects, in which the metabolic effects of a long term (90~     weeks) consumption of plant sterols and stanols (2.5 g/day) will be studied. After a run-in~     period of 5 weeks the subjects will be randomly divided into three groups of 20 subjects~     each. One group will continue with the control margarine without added plant sterols and~     stanols, one group will use a plant sterol margarine and the last group will use a plant~     stanol margarine for 85 weeks. The major endpoint will be endothelial function of the vessel~     wall, and in addition various parameters related to lipids and lipoprotein metabolism,~     erythrocyte characteristics and cognitive performance will be measured.~      Risk for subjects The margarines containing the plant sterols and stanols are safe and~     palatable. Venipunctures and other (non-invasive) measurements are carried out by skilled~     persons and not of any risk. A subject will spend approximately 1 hour a month in~     participating in the studies.~   "
223644|NCT00631280|"~     The purpose of the study is to determine whether active parent involvement in deliberation~     and choice improves subsequent medication persistence for their child with ADHD.~   "
210722|NCT00802503|"~     Rationale: Enteral nutrition (EN) in the intensive care (ICU) patients is recommended as a~     standard of care. However, EN alone is often associated with insufficient energy intakes and~     increased complication rates. Recently the investigators proposed to decrease this deficit by~     combining EN and supplemental parenteral nutrition (SPN) whenever EN is insufficient (< 60%~     of their predicted energy needs) at day 3 after admission in the ICU.~      Objective: This study aims at: a/ investigating if the delivery of optimal nutrition support~     (100 % of predicted energy targets) in ICU patients by the combined administration of SPN and~     EN optimizes their clinical outcome; b/ implementing the new ICU nutrition guidelines.~      Study design: Prospective, controlled, randomized clinical study.~      Study site: Service of Intensive Care, Geneva University Hospital.~      Patient population: 220 ICU patients to be included: expected length of stay > 5 days,~     expected survival > 7 days, no contraindication to EN, obtained informed consent from~     themselves or their next of keen.~      Exclusion criteria: refusal of consent, age < 18 years, short bowel syndrome, significant~     persistent gastrointestinal dysfunction with ileus, high output proximal fistula (> 1,5~     liter/d), patients receiving PN.~      Nutrition: At day 3 after admission, if energy input is < 60%; patients are randomized into~     either the Control group (EN alone) or the SPN group (EN + PN) to reach 100% of their~     predicted energy needs. Tight glycaemic control (target 6.0 to 8.3 mmol/l) to be achieved~     according to our local practice by insulin administration.~      Study endpoints:~        -  Primary: nosocomial infections (CDC criteria)~        -  Secondary: Mechanical ventilation duration, ICU and hospital length of stay, antibiotic~          free days, ICU complications (extra-renal epuration, neurological, cardiac and~          respiratory complications), energy and protein balance, 28 days clinical outcome.~   "
210723|NCT00802490|"~     The aim of this study is to investigate if electroencephalogram (EEG) biofeedback~     incorporating the use of video games is effective in improving inattentive symptoms in~     children with ADHD.~   "
210724|NCT00802477|"~     The purpose of this study is to determine if the application of autologous (your own blood)~     blood products during mastectomy improves wound healing and decreases complications following~     surgery compared to mastectomy without the use of autologous blood products.~   "
210725|NCT00802464|"~     The goal of this randomized observer-blind trial is to further refine the formulation of~     vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune~     responses and the safety profiles of the different formulations.~   "
210726|NCT00802451|"~     The purpose of this study is to evaluate the relative bioavailability of the test formulation~     of mesalamine suspension rectal enema with the reference formulation in healthy, adult~     subjects.~   "
210727|NCT00802438|"~     A drug (mepolizumab) that reduces allergic inflammation will affect the function of allergy~     cells called eosinophils which are produced by the body in response to allergen exposure.~   "
210728|NCT00802425|"~     The purpose of the study is to determine whether AM-111 is effective in the treatment of~     acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL).~   "
210729|NCT00802412|"~     The purpose of this study is to determine whether topiramate is effective as an aid to~     smoking cessation for recovering alcohol dependent men.~   "
210730|NCT00802399|"~     The purpose of this study is to describe a case series of patients with chronic dry eye~     submitted to partial punctual occlusion.~   "
210731|NCT00802386|"~     A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None,~     however, have screened women prior to inserting the IUD. No data exists detailing the status~     of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no~     inference can be made about the possible influence of IUD insertion and presence to the~     development of upper genital tract infection . Consequently, with the current literature, it~     would be difficult to make an argument for screening and treatment for BV prior to IUD~     insertion. This study will help us determine whether women with an IUD develop a change in~     the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In~     addition, in those women with BV, we are looking to see if they develop more significant~     problems with the IUD, than those who do not have BV. Overall, this will help us determine~     whether all women should be screened for BV prior to IUD insertion.~   "
210732|NCT00802373|"~     Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen~     for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB~     symptoms by patient diaries.~   "
210733|NCT00802360|"~     To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of~     follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone~     (GnRH) antagonist in vitro fertilization (IVF) cycles~   "
210734|NCT00802347|"~     The purpose of this study is to determine whether a single administration of QPI-1002 (also~     known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation.~     In this Phase I /II study, patients who are undergoing renal transplantation with organs from~     DCD donors, ECD donors or SCD donors with ≥ 24 hours of cold ischemia time who meet study~     entry criteria will be studied to evaluate the safety and pharmacokinetic profile of I5NP~     (Part A) and clinical activity of I5NP administration (Part B). Data from this study will be~     used to identify doses of I5NP to be used in follow-on efficacy studies.~      Part A will be a randomized, dose escalation study to determine the highest or maximum~     tolerated dose (MTD). Part A will enroll 40 patients at approximately 20 sites; patients will~     be randomized to receive either I5NP or placebo in a ratio of 8:2 in each cohort (cohorts~     1-4).~      Part B will utilize the dose identified in Part A to further evaluate, in a double-blind~     manner, the safety, and clinical activity of I5NP. In Part B, up to 326 patients will~     participate at approximately 60 sites; up to 163 patients will be randomized to receive I5NP~     and up to 163 patients randomized to receive placebo.~   "
210735|NCT00802334|"~     Evaluating the bioavailibility safety and efficacy of the generic LPV/RTV 200/50 mg tablet~     formulation in a 400/100 mg BID dose in Thai HIV infected individuals.~   "
210736|NCT00802321|"~     To monitor the inhibition of 5a-reductase (5AR) enzyme activity at 1, 3, 7, 14, 21, 28 and 42~     days following administration of a single dose of dutasteride (2, 3, or 4 mg) by measuring~     the change in blood levels of 3a-androstanediol glucuronide (3a-diolG) and the ratio of~     dihydrotestosterone (DHT) to testosterone. To accomplish this aim, an open-label,~     between-subjects dose comparison study design will be employed with subjects receiving a 2,~     3, or 4 mg dosage. Subjects (up to n=40 enrolled to allow a minimum of 24 completers) will be~     randomly assigned to one of the 3 dose levels. Results of this study will inform the dose~     selection for a subsequent placebo-controlled, within-subject, crossover study of dutasteride~     on the effects of alcohol.~      A secondary aim of this study is to examine the correlation of a genetic variation in the~     type I 5AR gene and baseline DHT/T ratio and effect of dutasteride at day 3. A variation in~     this gene which is one of the targets of dutasteride has been reported to be associated with~     higher baseline levels of DHT.~   "
210738|NCT00802295|"~     Our working hypothesis is that patients undergoing in vitro fertilization (IVF) with higher~     response to ovarian stimulation protocols recover a higher number of oocytes and, this~     elevated response could be translated into increased incidence of chromosomally abnormal~     embryos. Our objective is to develop a prospective study on healthy young donors, with a~     previous cycle with high ovarian response (>20 oocytes and/or E2 levels the day of the hCG~     injection >3000 pg/mL), but without developing mild or severe hyperstimulation syndrome.~     After signing a proper written consent, these donors would agree to undergo two subsequent~     stimulation cycles following two different protocols. In one cycle the stimulation pattern~     would be similar to the previous one, with elevated response and, in another cycle the amount~     of gonadotropins would be cut down in order to obtain lower ovarian response. Oocytes~     obtained in each cycle would be donated to anonymous recipients and after fertilization,~     embryo quality and chromosomal status of the resulting embryos would be evaluated.~     Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes~     13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence in situ hybridization~     (FISH).~   "
210739|NCT00802282|"~     This study will investigate the effects of psilocybin dose and the frequency and intensity of~     support activities for spiritual practice (e.g., meditation) on a battery of attitudinal and~     behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a program~     of spiritual practices with the intention applying spiritual insights and knowledge to~     everyday life. After screening and study enrollment, each volunteer will be assigned to one~     of five groups that vary in dose, frequency and intensity of support for spiritual practice,~     and number of psilocybin sessions (either 2 or 3 sessions). The psilocybin dose manipulation~     will be double-blind. Volunteers will be told that in each of sessions 1, 2, and 3, he/she~     could receive a very low, low, moderate, moderately high, or high dose of psilocybin. They~     will be told that each participant will receive 2 or more dose levels of psilocybin over the~     2 or 3 sessions, and all participants will have one or more sessions in which he or she~     receives a moderately high or high dose of psilocybin. The duration of each volunteer's~     participation will be approximately 6 to 8 months. Each volunteer will receive several hours~     of preparation with the study guides in the month prior to the first psilocybin session; the~     first two sessions will be separated by one month. Various measures will be assessed before,~     during and immediately after sessions. A battery of longitudinal measures will be evaluated~     immediately after study enrollment, 3 weeks after the second psilocybin session, and 4 months~     after the second psilocybin session (6 months after study enrollment). For purposes of~     controlling expectancies through the 6 month follow-up evaluation, volunteers and guides will~     not know which volunteers or how many volunteers will be scheduled for a third session.~   "
210740|NCT00802269|"~     The used of reduced fluence parameters for panretinal photocoagulation decreases pain as~     perceived by the patient, compared to traditional parameters.~   "
210741|NCT00802256|"~     A new Endodontic Cement (NEC) is being compared with mineral trioxide aggregate in pulpotomy~     of primary molars.~   "
210742|NCT00802243|"~     Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an~     incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered~     the standard treatment for bullous pemphigoïd in 2002. Topical corticosteroid requires an~     initial large hospitalization during the acute phase and rehospitalization during relapse.~     The usefulness of immunosuppressive drugs have suggested by uncontrolled study.~      In this way, leflunomide could be an alternative therapy, and to reduce relapse and/or~     resistance risks.~      This study could prove the efficacity of leflunomide, associated with short time topical~     corticosteroids.~   "
210743|NCT00802230|"~     Metoprolol succinate is a beta1-selective beta-blocker, becoming non-selective at higher~     doses, while carvedilol is non-selective. We examined whether metoprolol remained~     beta1-selective compared to carvedilol during dose up-titration in Class C heart failure (HF)~     Beta-blocker naïve patients.~      METHODS: Twenty-five NYHA FC II-III HF patients were randomized to carvedilol or metoprolol.~     Patients were studied at baseline and after 2 weeks of up-titration (metoprolol at 25, 50,~     100, and 200 mg daily; carvedilol IR at 3.125, 6.25, 12.5, 25 mg and 50mg twice daily).~     Beta2- blockade was determined by an infusion of terbutaline at 6 mg/kg over 1 hour. Glucose~     and potassium levels were serially measured at baseline, every 15 minutes for the 1st hour~     and 30 minutes for 2nd hour post-infusion. The median area under the curve (AUC) for glucose~     and potassium changes were calculated.~   "
210744|NCT00802217|"~     Safety and pharmacokinetic first-time-in-human study of orally administered civamide in~     healthy subjects.~   "
210745|NCT00802204|"~     Obese individuals have fewer striatal dopamine type 2 receptors (DRD2) than normal weight~     individuals. Lower DRD2 levels are associated with addiction and a decreased sense of~     pleasure.Obesity is also associated with insulin resistance (poor insulin action).We propose~     that insulin resistance and low DRD2 are associated. Using PET imaging,we aim to determine~     DRD2 binding potential (BP) in the brain is associated with insulin resistance and~     neuroendocrine hormone levels. Obese participants will be compared to lean, gender and age~     similar participants. We also aim to determine the effect of caloric restriction on DRD2 BP~     in obese subjects~   "
210746|NCT00802191|"~     Purpose of the study:~      The purpose of this study is to investigate the Wii remote game control device for use in the~     study of Movement Disorders. The term Movement Disorders refers to a group of abnormal~     medical conditions characterized by involuntary body movements. Current treatment of these~     disorders is primarily geared to improve symptoms. Rating scales are usually used to grade~     response to treatment. These rating scales require special training, take a lot of time, and~     often present with great variability. Thus, the development of a simple device to perform~     efficacy measurements offers a great advantage over current methods and is less costly.~   "
210747|NCT00802178|"~     In this study information is gathered about the treatment of Parkinson patients who present~     themselves in a neurological practice for the first time~   "
210748|NCT00802165|"~     This study is designed to evaluate whether or not electroacupuncture can have an effect on~     the pain threshold of the subject, as compared to sham treatment.~   "
210751|NCT00802126|"~     The purpose of this study is to report the treatment effect and safety of combined~     intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a~     reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to~     pathologic myopia.~   "
210752|NCT00802113|"~     The sequential combination of myeloablative therapy and autologous stem cell transplantation~     (APBSCT) followed by a reduced intensity allogeneic stem cell transplant (Allo SCT) and post~     SCT adoptive cellular immunotherapy will be well tolerated in patients with refractory or~     recurrent non-Hodgkin's lymphoma (NHL) and Hodgkin's disease (HD).~   "
210753|NCT00802100|"~     This study will compare the safety and effectiveness of three different antipsychotic~     medications, as well as the use of other medications to limit treatment side effects, in~     adults with schizophrenia.~   "
210754|NCT00802087|"~     The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet®~     hydrocodone formulations and compare to a marketed hydrocodone drug.~   "
210755|NCT00802074|"~     To date, no study has investigated whether there is a drug interaction between the protease~     inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL112775 is a randomized,~     open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir~     (APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, fasting, HIV-negative adults~     after administration of a 7-day regimen of RTG 400mg BID alone and after 14-day regimens of~     unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/RTV 100mg BID, or FPV~     1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent RTG 400mg BID. Blood~     samples for drug concentration measurement will be collected over 12 hours at the end of each~     dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with~     differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and~     lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C,~     will be repeated at follow-up post-study. Adverse events and adherence (by pill count and~     medication diary) will be assessed by the investigator/study personnel at the end of each~     dosing period~   "
210756|NCT00802061|"~     This study is designed to investigate the effect of body posture (particularly when sleeping)~     on the pressure in the eye. The effect of body posture on progressive glaucoma (glaucoma~     where a significant change i.e. a disc hemorrhage has occurred) is not known.~      The study will involve being admitted to the Sleep Unit of the University Health Network at~     Toronto Western Hospital for 1 night (14 hours). IOP will be measured in both eyes every 2~     hours with a Tonopen, along with brachial blood pressure (BP), in the sitting position until~     the patients reach their normal sleep cycle time. Patients will then be asked to sleep in~     either lying down or reclining at a 30 degrees position and have the IOP measurements and~     brachial BP every 2 hours in that position.~      The same cohort of patients will then be invited for a repeat 14 hour IOP and BP measurement~     but will change their position, i.e. sitting before will now be supine and vice versa.~   "
210757|NCT00802048|"~     Cardiac surgery often induces acute postoperative pain and moreover chronic dysesthesia~     frequently occur long-term after sternotomy. The high doses of intraoperative opioïds are~     well known to enhance postoperative hyperalgesia (HA) and a perioperative local anesthetic~     agent infusion is one of the therapeutic strategies used to limit this phenomena. The aim of~     this study was to evaluate the effectiveness of a continuous Ropivacaïne sternal infusion~     compared with a saline serum infusion to limit postoperative HA, pain and morphine~     consumption (M) after sternotomy in cardiac surgery.~      This strategy could lead to lower postoperative morphine consumption and opioïd induced~     hyperalgesia.~   "
210758|NCT00802035|"~     The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of~     different baclofen formulations.~   "
210759|NCT00802022|"~     Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitis~     (DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering~     form DM. The current available medication often provides insufficient pain relief and/or has~     unacceptable side effects. Spinal cord stimulation (SCS) has been used for over 30 years to~     treat neuropathic pain. Various small clinical studies have shown a beneficial effect of SCS~     on pain in PDP.~      Objective: This study is a preparation to a RCT to investigate whether SCS is a good~     indication in patients which suffer from pain with moderate-to-severe PDP in the lower limbs.~     The main objective of this study is whether SCS leads to sufficient pain relief and to obtain~     insight into the working mechanism of SCS. The hypothesis is that the effect SCS is most~     effective in patients without major sensory deficits. Furthermore, practical feasibility of~     the test procedures described in the study protocol will be examined, including the~     questionnaires to be filled out by the patient. Also, technical feasibility of SCS will be~     investigated. Besides the feasibility, the possibility of predicting successful pain relief~     by SCS by classifying patients according to the Michigan Diabetic Neuropathy Score will be~     assessed. Furthermore, possible other predictors for successful pain relief by SCS will be~     defined. Study design: the study is a pilot study in preparation to a RCT to investigate the~     effect of spinal cord stimulation on pain in moderate-to-severe PDP patients.~      Study population: patients suffering from moderate-to-severe PDP in the lower limbs as~     diagnosed by clinical symptoms and supported by the Michigan Diabetic Neuropathy Score.~      Intervention: patients will receive 2 weeks of trial stimulation and best (drug) treatment as~     usual.~      Main study parameters/endpoints: Main study parameter is the pain score as measured by a~     numeric rating scale (NRS) according to Jensen and a Patient Global Impression of Change for~     pain measured on a 7-point Likert scale.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: SCS related risks include: lead migration (14%), lead breakage (7%), implanted~     pulse generator migration (1%), loss of therapeutic effect, lost or unpleasant paresthesias~     (12%), infection or wound breakdown (10%), Pain at IPG incision site (12%), IPG pocket fluid~     collection (5%).~   "
210760|NCT00802009|"~     Patients undergoing surgery of the hand often are treated with a nerve block in the~     shoulder/neck area that provides anesthesia/numbing during surgery. Nerve blocks usually last~     for a few hours after surgery and provide pain relief for this period. It may be possible to~     extend the duration of anesthesia by using a steroid, which has anti-inflammtory properties.~     This study will compare the duration of the nerve block when dexamethasone (steroid) is added~     to the anesthetic injected around the nerve.~   "
210761|NCT00801996|"~     This protocol is designed to collect a small amount of blood and tissue from individuals with~     prostate cancer for extraction of DNA (genetic material) for the study of the genetic basis~     of prostate cancer. The study population will include individuals with known prostate cancer~     and controls without prostate cancer. The study will be conducted in Doha, Qatar at the Hamad~     Medical Corporation and Weill Cornell Medical College (Qatar). Individuals in the study~     population will be of Arab descent from Qatar. In this protocol, researchers will survey~     epidemiologic factors and medical records of patients with prostate cancer in order to study~     the clinical characteristics of these individuals. The researchers will collect blood and~     tissue samples to evaluate the genetic characteristics of individuals with prostate cancer.~     The researchers will also collect blood samples of individuals without prostate cancer to~     serve as a control. The goal will be to identify genes that are associated with prostate~     cancer and gene profiles that are associated with differing prognoses in individuals who have~     prostate cancer.~   "
210778|NCT00801762|"~     The goal of the study is to develop a novel approach to obtain real time optical biopsy of~     urinary tract pathology (e.g., bladder tumors) during urinary tract endoscopy using a novel~     fibered confocal microscope.~   "
210762|NCT00801983|"~     Awkward postures during computer keyboard use have been hypothesized to be one cause of~     musculoskeletal pain/discomfort as well as musculoskeletal disorders of the upper extremity~     (MSD-UE). Alternative computer keyboards purport to reduce musculoskeletal pain/discomfort~     and have been shown to change aspects of keyboard users' kinematics under laboratory~     conditions. However, research that has examined the effectiveness of alternative keyboards in~     reducing musculoskeletal pain/discomfort in the workplace is equivocal, and no study has~     examined the association between postures and musculoskeletal pain. The Aims of this 3-year~     prospective double cross-over trial are: 1) To examine the effectiveness of an alternative~     keyboard in reducing reports of pain over 6-months; 2) To examine the neutrality and~     stability of postures during keyboard use; and 3) To identify which postures are associated~     with lower levels of musculoskeletal pain. Seventy-five computer users will be randomly~     assigned to one of two keyboard use orders: Group 1 - AB (standard keyboard, alternative~     keyboard); Group 2 - BA (alternative keyboard, standard keyboard). All subjects will use~     their assigned keyboards for 6-months before switching to the next keyboard. Every week,~     subjects will report their musculoskeletal pain levels. Just prior to and just after each~     6-month intervention subjects' kinematics performances on the keyboards will be recorded at~     the worksite using the Keyboard - Personal Computing Style (K-PeCS) instrument and in a~     laboratory setting using 3-dimensional motion capture technology.~      Aim 1: To examine the effectiveness of an alternative keyboard in reducing pain over~     6-months.~      Hypothesis 1 (H-1) - At six months subjects using an alternative keyboard will have~     significantly lower musculoskeletal pain levels than when using a standard keyboard.~      Aim 2: To examine the neutrality and stability of postures during keyboard use.~      Hypothesis 3 (H-2) - Subjects using an alternative keyboard will have significantly more~     neutral postures than when using a standard keyboard at baseline and at 6 months Hypothesis 3~     (H-3) - Subjects 6-months keyboarding postures will remain equivalent to the keyboarding~     postures documented at baseline.~   "
210763|NCT00801970|"~     The purpose of this study is twofold:~        -  to understand the etiology and the essence of fear of childbirth~        -  to examine the implications and efficiency of several forms of psychological therapy.~   "
210764|NCT00801957|"~     Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were~     considered to benefit from vaccination to prevent invasive disease caused by Neisseria~     meningitides serogroup C.~   "
210765|NCT00801944|"~     Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose~     increase. Primary efficacy assessment of OAB symptoms by patient diaries.~   "
210766|NCT00801931|"~     Double umbilical cord blood transplantation (DUCBT) following high dose or reduced intensity~     conditioning will be well-tolerated and result in a high degree of engraftment in patients~     with selected malignant and non-malignant disorders.~   "
210767|NCT00801918|"~     The purpose of this study is to determine is Denileukin diftitox will be safe, well tolerated~     and induce a significant overall response alone and in combination with chemotherapy:~     ifosfamide, carboplatin and etoposide (ICE) and will be safe and well tolerated in a~     population of children, adolescents and young adults with relapsed or refractory anaplastic~     large cell lymphoma (ALCL).~   "
210768|NCT00801905|"~     The purpose of this study is to determine whether topical nepafenac (qid) is effective in~     preventing and treating macular thickening related pan-retinal photocoagulation in patients~     with diabetic retinopathy.~   "
210769|NCT00801892|"~     Daily physical activity is important to achieve glucose control in persons with type 2~     diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime~     symptom, excessive sleepiness, act as barriers to physical activity. We will examine if~     treatment of obstructive sleep apnea with continuous positive airway pressure results in~     increased physical activity in persons with type 2 diabetes.~   "
210770|NCT00801879|"~     Staphylococcus aureus is a bacteria that causes serious, often life threatening infections~     including pneumonia, wound, and bloodstream infections. Persons with AIDS are at high risk~     for S. aureus infections. They are also at high risk for nasal carriage of S. aureus. In~     fact, nasal carriage is a known risk factor for subsequent S. aureus infection. Topical~     mupirocin, an antibiotic when applied to the anterior nares, is a safe, effective way to~     eliminate S. aureus colonization. Some studies have shown that mupirocin can also decrease~     the risk of S. aureus infection, but many of those studies utilized historical controls and~     none were rigorously tested among AIDS patients over an extended period of time.~      The main purpose of this randomized, double-blinded, placebo controlled study is to determine~     if mupirocin can eliminate S. aureus nasal colonization in residents at PSI (inpatient, drug~     rehabilitation facility for AIDS patients in the Bronx.) PSI residents currently have a high~     incidence of S. aureus nasal colonization and infection. Nasal cultures followed by twice~     daily application of mupirocin vs. placebo for five days will be performed on a monthly basis~     for 8 months. the study will examine whether mupirocin decreases the incidence of S. aureus~     infections and prevents S. aureus nasal colonization. The study is important because it may~     show that mupirocin is an effective way to eliminate nasal colonization and prevent S. aureus~     infections in AIDS patients, among those at highest risk for serious S. aureus infection.~      Hypothesis: Monthly application of mupirocin will reduce nasal colonization with S.aureus~   "
210771|NCT00801866|"~     to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg),~     against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance~     in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative~     diabetic retinopathy (PDR) and good vision~   "
210772|NCT00801853|"~     A multi-center, Phase IIb, double-blind, randomized, placebo controlled, parallel-group,~     repeated-dose study in male and female patients with moderate to severe asthma in which~     patients will be stabilized on AEROVANT then doses of inhaled corticosteroids and LABA will~     be tapered. The hypothesis is that AEROVANT will improve asthma symptom control and decrease~     the need for inhaled corticosteroids and LABA, thus improving exacerbation incidence compared~     to placebo. Incidence of asthma exacerbation is the primary endpoint.~   "
210773|NCT00801827|"~     The purpose of this study is to look at certain areas of the brain that are related to~     addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors'~     (DRD2/3) and other studies have shown that obese people have less of these. We propose that~     low DRD2/3 availability seen in morbidly obese subjects will change with weight loss~     associated with bariatric surgery.~   "
210774|NCT00801814|"~     To determine palatability and extent to which escalating doses of a novel highly viscous~     polysaccharide [NVP] reduces postprandial glycemia when added to a liquid and a solid meal.~   "
210775|NCT00801801|"~     The purpose of this study is to assess the 2-month progression-free survival in patients with~     advanced or metastatic, non-squamous cell lung cancer treated with weekly low dose docetaxel~     in combination with a biologic dose of sorafenib.~   "
210776|NCT00801788|"~     The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet®~     oxycodone formulations and compare to a marketed oxycodone product.~   "
210777|NCT00801775|"~     The purpose of this study is to analyze whether calorimetry compared to conventional methods~     (i.e.blood culture systems)is superior to diagnose peritoneal dialysis related peritonitis.~   "
210779|NCT00801749|"~     Sleep relate to cognitive function.~   "
210780|NCT00801736|"~     Lung cancer is the leading cause of cancer death in the UK, leading to 34 000 deaths each~     year (22% of cancer deaths). Non-small cell lung cancer (NSCLC) is the most common histology,~     accounting for approximately 80% of cases and most present with advanced, stage IIIb or IV~     disease. The recommended treatment for advanced disease is a doublet platinum-based~     chemotherapy, although the survival benefits are modest. Even among those fit enough for~     chemotherapy, the response rate is only 20-40%, and median survival averages 9-10 months with~     the newer platinum-containing chemotherapy regimen (Schiller et al, 2002; Rudd et al, 2005;~     Lee et al, 2007). Only 11% of patients went on to survive 2 years when treated with the newer~     gemcitabine/carboplatin regimen established by the London Lung Cancer Group (Rudd et al,~     2005; Lee et al, 2007). New strategies are needed to further improve the prognosis of this~     disease.~   "
210781|NCT00801723|"~     Randomized, double-blind, comparative study versus placebo performed in patients from studies~     CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who~     achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of~     treatment.~      Patients in remission at the End of Study visit will be given the opportunity to enter the~     12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study~     visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will~     be no interruption of study treatment between the parent studies and this study.~      It is planned that approximately 150 patients will be enrolled in the study. Patients will be~     randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective~     of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a~     day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical~     relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and~     stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI~     items).~      During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1,~     3, 6, 9, and 12 months of treatment.~      Patients will be contacted by telephone on a monthly basis for safety assessment. In case of~     occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled~     visit at any time during the study.~   "
210782|NCT00801710|"~     This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray~     Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the~     true lumen of coronary vessels distal to a chronic total occlusion (CTO).~      The hypothesis is that the BridgePoint Medical System can do this without an increase in~     major complications.~   "
210783|NCT00801697|"~     This study will evaluate the safety and preliminary immune response to recombinant adenoviral~     serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.~   "
210784|NCT00801684|"~     The purpose of this study was to evaluate the efficacy, safety, and tolerability of single~     doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive~     pulmonary disease (COPD).~   "
210785|NCT00801671|"~     The purpose of this study is to determine whether CPAP is effective in the treatment of~     systemic hypertension.~   "
210786|NCT00801658|"~     Examination and follow-up of efficacy and safety of SLT in patients with unsufficient IOP~     control despite maximum tolerated topical therapy. In addition, it will be examined whether~     medical treatment can be reduced after the SLT procedure and whether filtering surgery - as~     the only remaining option - may be postponed.~   "
210787|NCT00801645|"~     The main purpose of this project is to investigate the effects of an exercise program on~     arterial function and cardiovascular diseases risk factors in obese and lean pre-pubertal~     children. This information will be used to underpin prevention strategies to reduce~     cardiovascular diseases in overweight youth.~   "
210788|NCT00801632|"~     In small initial studies, combined kidney and bone marrow transplants from the same donor~     have permitted some individuals to stop taking anti-rejection medicines without rejecting~     their transplant. This clinical trial will study this method in a greater number of people to~     determine if it is indeed effective and safe.~   "
210789|NCT00801619|"~     We will use information technology to integrate the 2004 American Academy of Pediatrics~     guidelines for management of neonatal hyperbilirubinemia with laboratory reporting of newborn~     bilirubin test results to improve physician adherence to the guidelines and quality of care.~   "
210790|NCT00801606|"~     A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN)~     combined, but neither of them alone, significantly increased weight gain during Tuberculosis~     (TB) treatment. There was a substantially larger beneficial effect on survival amongst those~     who received the combination of Zn and MN compared with those who received either Zn alone or~     MN alone. These exciting preliminary findings require further confirmation, as the data on~     mortality reduction was based on a post-hoc subgroup-analysis. Effects of MN and Zn~     supplementation has not been assessed in children with TB. Studies are urgently needed to~     evaluate the therapeutic potential of nutritional interventions on treatment outcome in~     children with TB. Simple and inexpensive nutritional interventions may substantially impact~     TB-related child morbidity and mortality in high-burden settings. The investigators thus,~     propose a randomized, double blind, controlled trial that will measure the effect of~     multi-vitamin/mineral supplementation on the efficacy of anti-TB treatment in newly diagnosed~     childhood pulmonary TB patients in Delhi.~   "
210791|NCT00801593|"~     Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of~     arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the~     only modality for the early diagnosis of TMJ involvement.~      Aim of the study is to compare symptoms and clinical findings with MRI and ultrasonography~     results and to describe the action of the current medication on the arthritis of the TMJs.~   "
210792|NCT00801580|"~     The patient receive 2 different drug combinations on this study. The first combination will~     consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate,~     doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The~     second combination will consist of another intensive chemotherapy regimen (methotrexate and~     Ara-C [cytarabine]).~   "
210848|NCT00800839|"~     The goal of this clinical research study is to learn if cyclophosphamide given after busulfan~     and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which~     transplanted tissue attacks the body into which it is transplanted) in patients receiving a~     stem cell transplant. The safety of this drug combination will also be studied.~   "
210793|NCT00801567|"~     This study aims to gather additional information to support the theory that bipolar disorder~     is due to cellular (mitochondrial) dysfunction. To test this theory adults with bipolar~     disorder who are not currently symptomatic will receive a one-time brain scan (magnetic~     resonance spectroscopy [MRS] scan) with light stimulation. To test whether any MRS findings~     are specific to bipolar disorder, healthy controls and adults with schizophrenia will also be~     included in this study.~   "
210794|NCT00801554|"~     The overarching aim of the study is to characterize children and adults with ASDs, and~     compare them with age-matched controls in relation to their functioning in family, academic,~     employment, and social spheres. Subjects will be comprehensively assessed in multiple~     non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial~     instruments.~   "
210795|NCT00801541|"~     To this study and identify the sequence of alterations occurring in the chorioretinal~     interface during progression of AMD from dry AMD to sight-threatening chorioretinal~     neovascularization (CNV).~   "
210796|NCT00801528|"~     A prospective, randomized, double blind study designed to investigate analgesic efficacy of~     wound infusion using diclofenac or ropivacaine following Cesarean section performed via a~     Pfannenstiel incision.~   "
210797|NCT00801515|"~     This is a compassionate study to provide continued access to maraviroc for only those~     subjects completing study A4001029 who are showing clinical benefit. Assessments of safety~     and tolerability of maraviroc when added to OBT will be continued.~   "
210798|NCT00801502|"~     The number of infants and children with allergic disease (dermatitis, allergies, asthma) has~     increased over the last several decades. This may be related to changes in diet. It is now~     thought that children become sensitised to allergens very early in life maybe even before~     they are born. Some studies show that a high omega-3 fat intake by mothers decreases risk of~     sensitisation in their babies. There is a biological mechanism to explain this. Omega-3 fats~     are found in oily fish like salmon. In the UK pregnant women are recommended to eat oily fish~     twice per week. However, consumption of oily fish is known to be low in pregnant women in the~     UK. This study sets out to identify the effects of increasing salmon intake in pregnant~     women. The hypothesis being investigated is that : increased consumption of oily fish during~     pregnancy by women at risk of having offspring who will develop atopy will increase their~     omega-3 fat and antioxidant status and that of their developing baby and will ameliorate the~     development of atopic markers and manifestations in the infants.~   "
210799|NCT00801489|"~     The goal of this clinical research study is to learn if gemtuzumab ozogamicin and idarubicin~     can be added to the combination of fludarabine, cytarabine, and Neupogen (Filgrastim) without~     increasing the risk of side effects. This study will also look at whether the addition of~     gemtuzumab ozogamicin and idarubicin will increase the long-term chances of patients~     remaining disease free.~      This is an investigational study. Cytarabine is FDA approved and commercially available for~     the treatment of AML. Fludarabine is FDA approved and commercially available for the~     treatment of chronic lymphocytic leukemia (CLL). Filgrastim is FDA approved and commercially~     available to treat fever associated with low white cell counts in patients with AML.~     Gemtuzumab ozogamicin and Idarubicin are FDA approved and commercially available for the~     treatment of acute leukemias, lymphomas, Hodgkin's disease and breast cancer. At this time,~     their use in combination is for research purposes only.~      Decitabine is FDA approved for treatment of myelodysplastic syndrome and is commercially~     available.~      The study doctor will explain how the study drugs are designed to work.~      Up to 200 patients will take part in this study. All will be enrolled at MD Anderson.~   "
210800|NCT00801476|"~     Young women with breast cancer have an increased breast tissue density and conventional~     imaging tests such as mammography and breast ultrasound are less sensitive and specific for~     detecting breast cancer than in older breast cancer patients. Breast MRI is an emerging tool~     that has been proven to improve the ability to identify breast cancers by determining the~     extent of disease and also detect multifocal, multicentric and bilateral breast cancers. To~     date, the role of pre-operative breast MRI is not clearly defined. The investigators are~     proposing a study to evaluate the impact of preoperative breast MRI on surgical~     decision-making in breast cancer patients <= 50 years. This may lead to improved~     characterization of breast cancers in these younger patients that may ultimately result in~     lower local recurrence rates in the future. The additional information attained through the~     breast MRI may also guide the use of radiation, chemotherapy and/or hormonal therapy in these~     patients.~   "
210801|NCT00801463|"~     The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii~     in treated Focal Segmental Glomerulosclerosis (FSGS).~   "
210802|NCT00801450|"~     Triamcinolone has already been used by different routes of administration to treat diabetic~     macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's~     infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in~     eyes with refractory diffuse diabetic macular edema are tested.~   "
210803|NCT00801437|"~     This study is designed to evaluate the safety and tolerability of Xalacom in patients with~     primary glaucoma~   "
210804|NCT00801424|"~     Eighty adult patients undergoing open colon surgery will be randomized to either:~        1. standard warming measures including heating sheets, warming of fluids, and insulation of~          limbs and head, or to~        2. additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100%~          relative humidity) via a humidifier with a heated tube (Fisher&Paykel) connected to a~          gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100%~          carbon dioxide (humidified ) in the open wound cavity.~      PRIMARY AIM The primary aim of this study is to evaluate if humidified carbon dioxide~     insufflated into an open surgical wound can be used to warm the core, the open wound cavity,~     and the wound edges during major abdominal surgery.~      SECONDARY AIMS Secondary aims are to evaluate possible differences between the groups~     regarding complications and clinical differences including histological signs of desiccation~     injury of peritoneal samples, time to extubation, core temperature after surgery, ICU stay,~     bleeding volume, hospital stay, postoperative pain, infections, shivering, postoperative~     signs of restored bowel function including bowel movements, flatus, and first meal.~   "
210849|NCT00800826|"~     This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine~     mixture for intravenous patient-controlled analgesia (PCA).~   "
210805|NCT00801411|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving combination chemotherapy before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet~     known which chemotherapy regimen is more effective in treating breast cancer.~      PURPOSE: This randomized phase II trial is studying cyclophosphamide given together with~     docetaxel to see how well it works compared with cyclophosphamide given together with~     doxorubicin in treating women with newly diagnosed breast cancer that can be removed by~     surgery.~   "
210806|NCT00801398|"~     When post-operative parenteral analgesia is discontinued, oral dosing with study medication~     may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS~     (pain intensity score greater than or equal to 40).~   "
210807|NCT00801385|"~     RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Sorafenib may also stop the growth of non-small cell lung~     cancer by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib~     works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has~     not responded to chemotherapy.~   "
210808|NCT00801372|"~     Induced pluripotent stem cells potentially may be useful in the future as an unlimited source~     of cells for transplantation.~      The major goal of the project is to develop human iPS cells from existing lines of~     fibroblasts that were originally donated as clinical grade feeders for the development of~     clinical grade hESCs. The clinical grade feeders were developed from aborted fetuses,~     foreskin and umbilical cord.~   "
210809|NCT00801359|"~     Two intraocular irrigating solutions (BSSPlus versus Lactated Ringer's) are compared in this~     prospective, randomized, masked trial to investigate for differences in preservation of~     corneal integrity after phacoemulsification cataract surgery.~   "
210810|NCT00801346|"~     RATIONALE: Gathering information about metabolic syndrome from young patients with acute~     lymphoblastic leukemia may help doctors learn more about the disease.~      PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute~     lymphoblastic leukemia in remission.~   "
210811|NCT00801333|"~     Induced pluripotent stem cells potentially may be useful in the future as an unlimited source~     of cells for transplantation.~      The major goal of the project is to develop human iPS cells from various types of cell~     cultures or lines from existing collections. The IPS cells will be developed for modeling~     diseases, for developing the technology that may eventually allow the use of IPS cells for~     transplantation therapy, and for basic research.~   "
210812|NCT00801320|"~     The purpose of this research study is to collect tumor samples at the time of surgery and~     store them for possible use as part of an experimental vaccine study for the participants~     cancer in the future.~   "
210813|NCT00801307|"~     This clinical trial will include healthy volunteers, COPD patients and asthmatic patients who~     will breathe He/O2 78:22, He/O2 65:35 and medical air consecutively in a randomised order.~   "
210814|NCT00801294|"~     The primary objective of this trial is to explore the overall objective best response rate~     and the rate of non-progression at 16 weeks of sequential, alternating weekly administration~     of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.~   "
210815|NCT00801281|"~     Evaluation of event free survival (EFS) of patients treated with the study chemotherapy~     induction program: R-CHOP compared to the standard R-CVP regimen and response rates, time to~     best response, PFS, OS, neutropenic fever rate, infection rate, change in Ig levels, change~     in lymphocyte subpopulations counts in previously untreated indolent lymphoma patients in~     need of systemic treatment.~   "
210816|NCT00801268|"~     Triptolide has been approve effective in animal model.~   "
210817|NCT00801255|"~     This 7 cohort study will evaluate the efficacy and safety of combination treatment with an~     HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease~     inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype~     1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be~     treatment-experienced excluding null responders, and cohort F will be null responders.~     Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591,~     alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment~     with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and~     200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h~     RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily~     for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice~     daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by~     appropriate safety and pharmacokinetic data.Following the last dose of study medication~     patients have the option of continuing treatment with Standard of care therapies. The~     anticipated time on study treatment is <3 months, and the target sample size is <100~     individuals.~   "
210818|NCT00801242|"~     The purpose of this uncontrolled, multi-center, open-label trial was to investigate the~     feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the~     treatment of prostate cancer.~   "
210819|NCT00801229|"~     The primary objective of the study is to assess the benefice of Vyvanse on the factors that~     cause impairments in driving behavior in individuals with ADHD using a driving simulation~     aimed at examining the factors that cause impairments in driving behavior in individuals with~     ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages~     18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show~     lower velocity (speed) scores and spend less time driving over the posted speed limit in the~     driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD~     treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing~     peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser~     likelihood of driving through stop signs and solid red traffic lights without slowing down~     when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with~     Vyvanse will exhibit more focused visual attention on details in the visual field when~     compared to subjects taking a placebo while driving. In addition, young adults with ADHD~     treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when~     compared to subjects taking a placebo.~   "
210820|NCT00801216|"~     This prospective trial will assess the activity and feasibility of a new high-dose~     methotrexate-based high-dose sequential chemotherapy combination in patients with B-cell~     lymphomas and CNS involvement at diagnosis or relapse. Selected drugs, with a well-documented~     anti-lymphoma activity, will be administered at high doses to increase blood-brain barrier~     penetration and CNS bioavailability as well as to reduce potential cross-resistance.~   "
210821|NCT00801203|"~     This study is to evaluate the effectiveness of identifying stress urinary incontinence (SUI)~     in female subjects using the Induced Reflex Cough Test (IRCT) administered with urodynamic~     testing by evaluation of sensitivity and specificity.~   "
210822|NCT00801190|"~     The overall aim of this study is to determine if there is a bleeding risk associated with the~     use of starch-containing fluids during cardiac surgery. The specific purpose of this study~     will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the~     effects of colloid (HES 130/0.4) vs. crystalloid (Ringer's Lactate) on bleeding in patients~     undergoing cardiopulmonary bypass for cardiac surgery. The primary end point of this trial~     will be chest tube output at 24 hours. In addition, a range of secondary end points focusing~     on transfusion parameters, as well as other important end-organ outcomes, will be determined.~   "
210823|NCT00801177|"~     The purpose of this study is to determine if IMC-11F8 is safe for patients, and also to~     determine the best dose of IMC-11F8 to give to patients.~   "
210824|NCT00801164|"~     The goals of this exploratory study are to 1)examine an investigational oral rinse as an~     adjunctive agent to scaling and root planing in treating chronic periodontitis in a~     periodontitis-susceptible diabetes population, and 2) evaluate its effect on glycemic control~     and biomarkers of systemic inflammation.~   "
210825|NCT00801151|"~     This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given~     in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine~     (25mg/m²/week continuously, representing the schedule that has been approved). Patients~     eligible will be enrolled into a standard 3+3 design with a starting dose of vorinostat at~     200 mg po qd 7/21 (weekly schedule). Then, further dose levels will be explored. Toxicity of~     the schedule will be assessed during the first cycle. Patients may receive up to 6 cycles of~     study medication. Blood samples will be collected at specified time points to assess~     pharmacokinetic endpoints.~   "
210826|NCT00801138|"~     This study will test the hypothesis that adding dexamethasone significantly prolongs the~     duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect~     differs among the two local anaesthetics.. Participants will be patients undergoing shoulder~     surgery with an interscalene nerve block.~   "
210827|NCT00801125|"~     The purpose of this study is to demonstrate the safety, tolerability and clinical benefit of~     TYSABRI® (natalizumab) in patients with moderately to severely active Crohn's disease.~   "
210828|NCT00801112|"~     Hypothesis: The investigators hypothesize that regular monitoring of BIA adds value to the~     management of fluid status in PD patients~      Objectives of the study: The objective is to show that in patients where the additional~     information of body composition is available to the clinician that the ECFv is maintained~     within pre-agreed limits, ~ 1 liter, over the observation period of 12 months.~      SCIENTIFIC BACKGROUND:~      Low peritoneal ultrafiltration, and by inference low sodium removal, is associated with worse~     outcomes in PD. Equally, excessive fluid removal is a risk factor for dehydration and loss of~     residual renal function. Current guidelines have advocated a daily UF volume of 1litre; their~     blunt application could lead to either inappropriate early loss of residual function or~     modality transfer. There is a significant need for evidence on how to best manage fluid~     status in PD patients, both in terms of an appropriate clinical strategy and also a simple~     but reproducible tool to guide clinicians in how to apply this strategy.~      It is likely that BIA will become the standard tool to aid clinicians in assessing fluid~     status. It is simple to perform, intervention studies have demonstrated its ability to~     identify changes in fluid status in response to changes in therapy and it is a powerful~     predictor of patient survival. There is, however a clear need at this stage for proof of~     principle studies to establish its true potential for added value in the routine management~     of patients.~      Body composition changes spontaneously with time on PD. Short term changes in hydration~     (specifically extracellular fluid volume, ECFv) combined with medium term changes in muscle~     and fat make it difficult for the clinician to be sure if fluid status is stable. It is~     anticipated that regular BIA measurements will aid the clinician in managing this problem~     over and above monitoring of weight and fluid status. By randomizing patients into two groups~     who have regular BIA measurements, one of which the BIA data is available to the clinician it~     will be possible to see if these spontaneous changes in body composition can be accounted~     for.~   "
210829|NCT00801099|"~     In a rural hospital in Tanzania the rate of surgical site infections (SSI) was 21.6%.~     Inappropriate choice of antibiotics and of administration time were determined as sole risk~     factors in this setting. After implementation of a standardized procedure with a single shot~     dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively the rate of SSI~     dropped by 80% in spite of procedural risk factors like poor hygiene etc.~   "
210830|NCT00801086|"~     Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can~     contribute to the distress and social isolation of patients with advanced cancer. In this~     study a topical gel will be applied directly to the scalp during each dose of radiotherapy.~     The goal is to determine to what extent the experimental drug is successful in lessening the~     hair loss.~   "
210831|NCT00801073|"~     The purpose of this study is to evaluate the use of preserved scleral, corneal and amniotic~     membrane graft for the surgical repair of scleral thinning of different sizes in patients~     underwent surgery of pterygium with associated beta therapy .~   "
210832|NCT00801060|"~     This is a Phase 2, randomized, open-label, multicenter study in subjects with previously~     untreated CLL. It is designed to evaluate safety and efficacy of fludarabine,~     cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.~   "
210833|NCT00801047|"~     Women requesting analgesia do not always wish to receive a potent analgesic method, and may~     fear the risks of epidural analgesia.~      Study Aim: To determine whether remifentanil is effective for labor analgesia when compared~     with standard treatment (epidural analgesia).~   "
210834|NCT00801034|"~     In humans living of fruit and vegetables, hypertension is rarely seen. We wish to study if~     the development of hypertension has a connection to our intake of potassium. We know that~     fruit and vegetables contain a lot of potassium and we will simulate this intake by giving~     healthy subjects potassium as tablets.~   "
210835|NCT00801021|"~     The purpose of the study is to determine the effect of an investigational oral rinse in~     reducing uropathogens and treating uncomplicated urinary tract infections.~   "
210836|NCT00801008|"~     The purpose of this study is to develop an exercise and relaxation program for young adults~     (age 18 to 39) who have completed their treatment for cancer.~   "
210876|NCT00800475|"~     The purpose of this study is to determine whether two oral formulations of Gemfibrozil~     Tablets are bioequivalent.~   "
210837|NCT00800995|"~     INTRODUCTION:~      Acting directly on the anti-radical enzyme chain, the superoxide dismutase (SOD), a major~     enzyme of the anti-oxidant system, provides an alternative of the antioxidants treatment in~     ARMD. Its synthesis depends on the cellular oxygenated reactive species, and leads to the~     conversion of the superoxide ion (O2-) into hydrogen peroxide (H2O2). This compound is the~     cell watch guard continuously regulating a free radicals' detoxifying chain. Subsequently, by~     increasing the production of H2O2, the administration of SOD can trigger endogenous/internal~     antioxidant mechanisms.~      Oral administration of SOD is possible in its galenic form, Glisodine. The purpose of this~     study was to evaluate the protective effect of SOD on the bilateralization of the disease.~   "
210838|NCT00800982|"~     This is a single-center, open-label, pilot study. A total of 30 subjects (15 in each study~     arm) will be enrolled in this 6 month study to evaluate whether the addition of narrow band~     UVB (NB-UVB) phototherapy can enhance the efficacy of etanercept's maintenance dose, 50 mg~     once a week, in obese psoriasis patients.~   "
210839|NCT00800969|"~     This prospective study includes patients with histologically proven cancer of the~     esophagogastric junction (Siewert Type II and III) and the stomach. Aim of the study is to~     evaluate the accuracy of PET-CT for the preoperative assessment of lymph node metastasis. The~     evaluation includes a combination with standard diagnostic tools (endoluminal ultrasound, CT~     and diagnostic laparoscopy prior to neoadjuvant therapy). Standardized D2-lymphadenectomy is~     performed and individual lymph node stations (Nr 1-12 according to the Japanese~     classification) are histopathologically examined. Furthermore we evaluate the role of the~     PET-CT for early metabolic response evaluation in patients receiving neoadjuvant~     chemotherapy.~        -  Trial with surgical intervention~   "
210840|NCT00800956|"~     The purpose of the study is to learn more about how esreboxetine is handled by the body i.e.~     the absorption, metabolism and excretion of esreboxetine.~   "
210841|NCT00800943|"~     To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to~     chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in~     patients who have achieved a complete remission (CR) or b) convert partial remission to~     complete remission.~      To evaluate the time-to-progression of patients according to pretreatment characteristics and~     response status at study entry.~      To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to~     chemotherapy will eliminate minimal residual disease as determined by real-time quantitative~     PCR.~   "
210842|NCT00800930|"~     Shigellosis is one of the major causes of morbidity and mortality in many developing~     countries. The continued emergence of antibiotic resistant strains has complicated the~     treatment of shigellosis and has increased the cost of treatment markedly. Antimicrobial~     peptides are considered as endogenous antibiotic. A mixture of these antimicrobial peptides~     (LL-37 and beta-defensin) drenches the mucosal epithelial surfaces forming a barrier for~     invading microorganisms. Recently, we found that Shigella down-regulates the expression of~     LL-37 and beta-defensin 1 (HBD-1) in the colon of patients during acute shigellosis thereby~     facilitating bacterial invasion. Both LL-37 and HBD-1 could inhibit the growth of various~     microbes e.g. S. dysenteriae type 1, S. flexneri, and S. boydii. Our study indicated that~     bacterial DNA might be a potential mediator for the down- regulation in vitro.~     Down-regulation of LL-37 and HBD-1 was also seen in watery diarrhea caused by other~     pathogens. Thus, bacteria-mediated down-regulation of our front line defenses could be one~     strategy evolved by the pathogens to subvert this host-defense mechanism. gene encoding LL-37~     in cultured epithelial cell lines were up-regulated when treated with butyrate; butyrate~     decreased the severity of Shigella infections in rabbit model. We could reproduce our~     findings from human i.e. downregulation of CAP-18 (the rabbit homologue to human LL-37) in~     colon epithelia after infection with Shigella flexneri. CAP-18 reappeared after treatment of~     the infected rabbits with sodium butyrate. Thus, the rabbit model demonstrated the proof of~     principal. In this study, we aim to assess the efficacy of sodium butyrate enema in reduction~     of clinical symptoms and / severity, reduction of inflammatory responses and induction of~     endogenous antibiotic activity in the rectum in adult patients with shigellosis.~   "
210843|NCT00800917|"~     This trial is an investigator initiated, open label phase II study, where patient with~     recurrent primary GBM will be considered for the study. Only patients with recurrence after~     Temozolomide and VEGF-directed therapy with Bevacizumab will be considered for the study.~     Patients will receive temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15 and 22 and~     bevacizumab 10 mg/kg IV over 30-90 minutes on day 8 and 22. Treatment repeats every 28 days~     for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. A~     safety analysis will be performed when the first 10 patients have received minimum 4 cycles~     (8 weeks). The study will then be stopped:~      If DLT is observed in > 2/10 patients, Occurrence of any serious adverse events not described~     in the SPC of each agents, If partial remission is not observed in at least 1/10 patients~   "
210844|NCT00800904|"~     The purpose of this study is to determine the percentage of patients who has reached the GINA~     guideline of asthma treatment after receiving any inhaled corticosteroid for 3 months or~     longer in actual clinical practice. Such percentage for each level of severity - mild,~     moderate and severe persistent asthma as well as the differences of these rates will also be~     explored.~   "
210845|NCT00800878|"~     The Indo-Asian developing countries are facing an epidemic of chronic diseases including~     hypertension, diabetes and chronic kidney disease (CKD). Diagnosis of early CKD is essential~     for institution of effective and timely prevention of its complications; costly late stage~     treatment for end stage renal disease is currently an unfeasible option in these populations.~     GFR estimates of kidney function provide a common reference standard for all people and are~     therefore readily applicable by physicians and understood by patients. However, the existing~     GFR equations yield widely discrepant results in the Indo Asian population, and none of the~     currently available estimating equations have been validated in this population.~      The main objective is to develop a tool which can be used for screening subjects at high risk~     for developing CKD (with hypertension and diabetes) as well as the general population.~   "
210846|NCT00800865|"~     A study to evaluate biomarkers of cancer (context-specific sensitizers) in the skin of~     participants already receiving cytotoxic therapy. Additional blood and urine samples will be~     collected for phosphorylated Histone 2AX (γH2AX) and renal toxicity biomarker testing,~     respectively.~   "
210847|NCT00800852|"~     The inflammatory process is involved in the pathogenesis of obesity. Prader-Willi syndrome~     (PWS) is a genetic model of syndromic obesity. Adiponectin is an adipokine with potent~     anti-inflammatory properties, and its effect is mediated through adiponectin receptors 1~     (adipoR1) and 2 (adipoR2).~      Objective of this study is to compare the expression of adipoR1, adipoR2, and adiponectin in~     peripheral blood mononuclear cells (PBMCs) in PWS children and obese control and to correlate~     receptor expression with insulin sensitivity and obesity-related parameters.~   "
210850|NCT00800813|"~     Some men complain of changes in the shape or dimensions of their penis after undergoing~     radical prostatectomy (removal of the prostate) for prostate cancer. Changes in penile~     dimensions include shortening or decreased girth. Changes in shape include a curvature or~     bending of the penis, and/or the appearance of indentation. These changes may be associated~     with formation of scar tissue involving the covering of the erection chambers, known as~     plaque. The appearance of indurated plaque and a resultant curvature or indentation is a~     well described medical condition known as Peyronie's Disease and may occur in men who did~     or did not undergo radical prostatectomy. The purpose of this study is to evaluate these~     changes in penile shape and dimensions.~   "
210851|NCT00800800|"~     The purpose of this study is to assess the effects of rosuvastatin compared to usual care in~     patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to~     moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering~     agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year~     recruitment period, and a treatment duration of a minimum of 3 years from the time of the~     last patient randomized to a maximum of 5 years.~   "
210852|NCT00800787|"~     A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB,~     administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who~     underwent liver transplantation.~   "
210853|NCT00800774|"~     The purpose of this study is to determine the safety, efficacy, predictability, and stability~     of laser in situ keratomileusis (LASIK) to correct high anisometropia in patients 8 to 15~     years old in whom conventional treatments have failed.~   "
210854|NCT00800761|"~     Myocardial iron overload is the leading cause of death in patients with beta-thalassemia~     major (TM). Therapy with deferoxamine (DFO) combined with deferiprone (DFP) reduces~     myocardial iron and improves cardiac function. However, the prognosis for TM patients with~     established cardiac disease switched from DFO monotherapy to combined DFP/DFO chelation is~     unknown. Twenty-eight TM patients with cardiac disease were enrolled in a prospective study~     lasting 42±6 months. Fifteen (9 high-ferritin and 6 low-ferritin) were placed on DFP/DFO~     (DFP, 75 mg/kg t.i.d.; DFO, 40-50 mg/kg over 8-12 h at night 5-7 d/wk), while 13 (5 high- and~     8 low-ferritin) received DFO alone. No cardiac events were observed among high-ferritin~     patients on combination therapy, whereas 4 cardiac events (p=0.0049), including three deaths,~     occurred in high-ferritin patients on DFO monotherapy. These findings demonstrate that in TM~     patients with well-established cardiac disease combined iron-chelation therapy with DFP/DFO~     is superior to DFO monotherapy.~   "
210855|NCT00800748|"~     This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon~     alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants~     were studied; 1) those with elevated alanine transaminase (ALT) levels, 2) those with normal~     ALT levels, and 3) those with human immunodeficiency virus (HIV) co-infection. Participants~     with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous~     (SC) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (PO) daily (dependent on~     body weight) for 48 weeks. Those with genotype 2 or 3 received peginterferon alfa-2a 180 mcg~     SC qw + ribavirin 800 mg PO daily for 24 weeks, and all participants with HIV co-infection~     received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.~   "
210856|NCT00800735|"~     This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or~     in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have~     participated in a previous Roche or Roche partner protocol where access to treatment or~     re-treatment was promised or deemed appropriate following completion of the original protocol~     ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS~     monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus,~     800-1200 mg daily, as continuation of treatment after the wash-out period defined in their~     donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48~     weeks in genotype G1 with a treatment-free follow up period of 24 weeks.~   "
210857|NCT00800722|"~     The purpose of this study is to improve port wine stain therapeutic outcome in response to~     laser therapy. The researchers want to determine whether the combined use of pulsed dye laser~     therapy and rapamycin will improve PWS therapeutic outcome.~   "
210858|NCT00800709|"~     In AD, tau protein is abnormally hyperphosphorylated. Significant changes of~     hyperphosphorylated tau levels in CSF are found in AD patients. It has been shown in vitro~     that memantine can reverse abnormal hyperphosphorylation of tau in hippocampal neurons of~     rats. A statistically significant reduction of CSF phosphorylated tau at a preliminary 1-year~     follow-up was observed, from median 126 (interquartile range 107-153) to 108 (88-133) ng/l (p~     = 0.018). No statistically significant differences of total tau or Aβ42 were found~     (Gunnarsson MD, 2007).~      FDG-PET has the unique ability to estimate the local cerebral metabolic rate of glucose~     consumption, thus providing information on the distribution of neuronal death and synapse~     dysfunction in AD in vivo (Herholz K. 2003). Synaptic dysfunction and loss induce a reduction~     in neuronal energy demand that results in decreased glucose metabolism. Hypometabolism in AD~     is thought to reflect loss of synaptic activity and density (Herholz K. 2003; Mielke R, et~     al. 1998).~      Another biological markers such as inflammatory factor and APOEε4 also play a part in the~     onset of AD (Glodzik-Sobanska L, 2007).~   "
210877|NCT00800462|"~     This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and~     safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide) with~     one standard drug (Oxybutynin Chloride) for treatment of overactive bladder in individuals~     with spinal cord injury.~   "
210893|NCT00800254|"~     The purpose of this study is to determine whether early intervention with neuromuscular~     electrical stimulation (NMES) for muscle strengthening immediately after total knee~     arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in~     quadriceps muscle activation, force production, and function in older adults.~   "
210894|NCT00800241|"~     The purpose of this study is to determine the incidence of misuse, i.e., over-use and~     under-use, of Budesonide/formoterol for maintenance and reliever therapy in usual-care~     setting.~   "
210925|NCT00799812|"~     Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3~     swabsticks used one-at-a-time. Hibiclens applied according to the manufacturer's directions.~     Sterile swabsticks (wetted with sterile water) applied using the same method as the~     ChloraPrep Swabstick.~   "
210859|NCT00800696|"~     The purpose of the investigators project is to examine if the investigators may affect a~     reduction in respiratory infections in a pediatric long term care facility by institution of~     a comprehensive oral care program. The investigators wish to base their project on work such~     as of Yoneyama et al 2002, which hypothesized and showed that silent aspiration of~     oropharyngeal contents is a causative factor in development of respiratory infection in~     elderly institutionalized clients. It was found that an advanced oral hygiene program greatly~     reduced the incidence of respiratory infection. Although no similar research projects were~     found to have involved children, the investigators hope that a similar program of oral care~     will allow the investigators to likewise reduce the incidence of respiratory infection among~     the pediatric clients in our facility.~      The investigators propose to examine two groups of children which are fed by gastrostomy~     feedings only. One group will continue to receive oral care as performed today. The study~     group will have their teeth brushed three times a day by the nursing staff by using a suction~     connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of~     chlorhexidine varnish or another suitable antibacterial agent in the oropharynx.~      The investigators will retrospectively examine our records (a 12 month period) for febrile~     days, antibiotic use and hospitalization days due to respiratory causes. The investigators~     will then compare these to the febrile days, antibiotic use and hospitalizations to the 12~     month period [post implementation of the oral care program.~      The importance of this program is to examine whether by implementation of a relatively~     inexpensive and low-tech intervention may meaningfully reduce the morbidity and mortality due~     to respiratory infection among our clients (which from our experience is the main cause of~     morbidity and mortality in the investigators institution). The investigators expect that by~     reducing the incidence of respiratory disease among our clients that the investigators will~     greatly reduce suffering among the children and their families, improve their quality of life~     and ease the financial and organizational burdens as a result of caring for respiratory~     infections.~      As was noted before, no prior research was found which studied the pediatric population in a~     long term care facilities. It is our belief that this project represents a unique research~     opportunity which may bring great benefit to the children and caregivers.~   "
210860|NCT00800683|"~     to determine safety, efficacy and tolerability of BI 1356 versus placebo~   "
210861|NCT00800670|"~     The purpose of this Phase 1 study is to evaluate the safety and immune responses of a new~     tuberculosis vaccine, Ad5Ag85A, administered to healthy volunteers. 48 subjects will be~     recruited, 24 who have previously been vaccinated with BCG and 24 who have not received BCG~     vaccine. Two doses of the vaccine will be compared.~   "
210862|NCT00800657|"~     Same patients with dilated myocardiopathies with large areas of fibrosis has not been as~     successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional~     class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant~     with Cardiac Resynchronization Therapy in these patients.~   "
210863|NCT00800644|"~     The goal of this study is to estimate how often pelvic fractures occur in women treated with~     radiation therapy for either newly diagnosed or recurrent cervical, endometrial, or vaginal~     cancer. The study will also estimate the changes in bone mineral density and the changes in~     the blood that relate to bone turnover. High bone turnover can weaken bones and make you~     more likely to break a bone.~   "
210864|NCT00800631|"~     The development and severity of sepsis induced myocardial dysfunction can be monitored from~     the serum biomarker.~   "
210865|NCT00800618|"~     The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy~     young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873~     has on sex hormones in healthy young women~   "
210866|NCT00800605|"~     The purpose of this study is to demonstrate the efficacy of an investigational Vero~     cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza~     virus that is antigenically similar to one of the three strains in the vaccine. Subjects will~     be randomized in a double-blind fashion to receive a single intramuscular injection of either~     the investigational vaccine or placebo. Blood will be drawn from all subjects for a~     determination of hemagglutination inhibition antibody titers on Days 0 and 21, body~     temperature and injection site reactions will be monitored daily for 7 days. In addition,~     subjects must return to the clinic promptly to have swab samples of their nose and throat~     taken whenever they feel flu symptoms and all subjects will be monitored for adverse events~     until Day 180.~   "
210867|NCT00800592|"~     The objective of this study is to assess the safety, tolerability and pharmacokinetics of~     intravenous sildenafil (10 mg) administered as a bolus injection to patients with Pulmonary~     Arterial Hypertension already receiving and stable on oral Revatio 20 mg TID.~   "
210868|NCT00800579|"~     The purpose of this study is to evaluate the safety and tolerability of escalating doses of~     GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore~     airway hydration and mucociliary clearance in the lung.~   "
210869|NCT00800566|"~     The goal of this clinical research study is to find the highest tolerable dose of clofarabine~     when given to patients with CLL. The safety of this drug will also be studied.~   "
210870|NCT00800553|"~     The purpose of this study was to characterize how the anti-cholinesterase inhibitor (AChE-I)~     donepezil modulates brain regions involved in visual short-term memory, episodic memory and~     inhibitory efficiency following 24 hours of total sleep deprivation using fMRI as an~     additional marker for drug effect.~   "
210871|NCT00800540|"~     The purpose of this study was to compare the short term effects of two intraocular pressure~     (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular~     pressure, and blood pressure in patients with glaucoma. Ocular perfusion pressure (OPP) is~     defined as the difference between arterial blood pressure (diastolic and systolic) and~     intraocular pressure. The primary efficacy assessment is based on diastolic ocular perfusion~     pressure.~   "
210872|NCT00800527|"~     In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with~     diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the~     patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain~     syndromes.~   "
210873|NCT00800514|"~     The study will explore the neurocognitive effect of four weeks of treatment with amantadine~     versus placebo in patients with traumatic brain injury using the Interval Bisection Timing~     Task. Approximately 16 individuals with traumatic brain injury are expected to participate in~     this study. Subject participation is expected to last up to 8 weeks with 16 study visits.~   "
210874|NCT00800501|"~     This study is conducted to evaluate the safety and tolerability of the drug product sNN0029,~     containing the growth factor VEGF165, when administered directly into one of the fluid filled~     cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump.~     Patients with Amyotrophic Lateral Sclerosis will be enrolled.~   "
210875|NCT00800488|"~     The primary objective is to study the value of serum procalcitonin as a predictive marker for~     severe bacterial infection in febrile infants.~      2200 febrile infants aged less than 3 months will prospectively be included. All infants will~     have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin~     concentration in infants with and without serious Bacterial infection.~      Evaluation of the area under the ROC for Procalcitonin concentration.~   "
210878|NCT00800449|"~     The Haptoglobin (Hp) gene locus at chromosome 16q22 is polymorphic with two alleles denoted 1~     and 2 .The gene product exists in three phenotypes: 1-1, 2-1, and 2-2.~      The Haptoglobin 2 allele is found only in man and is believed to have arisen from the~     Haptoglobin 1 allele by a partial intragenic duplication. Haptoglobin 2 allele frequency is~     higher than the Haptoglobin 1 allele. It has been hypothesized that the Haptoglobin 2 allele~     was spread in man due to its selective advantage against life-threatening infections.~      In vitro, only the Haptoglobin 2 allele protein, binds to the streptococcus T antigen,~     resulting in its aggregation and slowing its growth .~      Individuals homozygous for the Haptoglobin 1 allele (1-1 genotype) are more prone to the~     streptococcal infection than individuals with the Haptoglobin 2 allele(2-1 or 2-2 genotype).~      The investigators wish to explore the linkage between Hp phenotype and sepsis in pre-term~     neonates, considering that in this early stage in life, genetic properties which provide a~     defense against infectious agents will be of heightened importance.~   "
210879|NCT00800436|"~     This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that~     results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and~     in HER2-positive female participants. The study will also assess the safety and tolerability~     of the SC and IV formulations. In Part 1 of the study, four cohorts will be treated with a~     single dose of Herceptin as follows: Cohort 1 (6 milligrams per kilogram [mg/kg] IV in~     healthy male participants); Cohort 2 (6 mg/kg IV in HER2-positive female participants);~     Cohort 3 (6 mg/kg SC in healthy male participants); Cohort 4 (10 mg/kg SC in healthy male~     participants). An additional cohort of healthy volunteers (Cohort 5) will be opened if both~     SC dose levels from Cohorts 3 and 4 result in Herceptin exposures different from the target~     concentration produced by a single IV dose, or if the variability in pharmacokinetic (PK)~     parameter values cannot be used to define the target SC dose level. In Part 2 of the study,~     HER2-positive female participants will receive a single dose of SC Herceptin at the dose~     level defined in Part 1. Participants from Part 1 are eligible to enter Part 2 provided they~     receive the second (Part 2) study dose of Herceptin a minimum of 22 days after their first~     (Part 1) dose.~   "
210880|NCT00800423|"~     Most patients undergoing cataract surgery suffer from corneal edema after the surgery.~      Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have~     made several clinical observations that patients receiving Brimonidine drops had a faster~     resolution of their corneal edema even if they had normal intra-ocular pressure.~      The investigators believe that administering topical Brimonidine to patients with significant~     post operative corneal edema will hasten the resolution of their corneal edema.~   "
210881|NCT00800410|"~     The objectives of the proposed study are to determine whether culturally diverse community~     residents with diabetes are willing to participate in our community health worker~     intervention using randomized controlled trial (RCT) methods and to explore and document~     effective processes and protocols for RCT methods in these communities. The investigators~     will examine retention rates, identify reasons for attrition through interviews and focus~     groups, and determine strategies for improving recruitment, retention, and intervention~     methods. As a secondary objective, the investigators will explore the potential impacts of~     the intervention for improving healthy lifestyles, diabetes self-management, and selected~     health outcomes of participants.~   "
210882|NCT00800397|"~     Medical literature has shown that 1 out of 2 patients that are admitted to the hospital as a~     cardiac patient, will be found suffering from sleep breathing disorders. The medical~     literature also shows that there is an advantage of treating the sleep breathing disorders in~     addition to treating the cardiac disease or evaluating the heart failure condition to provide~     better clinical outcomes.this study is evaluating the ability to detect sleep and cardiac~     related breathing disordered.~   "
210883|NCT00800384|"~     This trial will assess the safety of defibrillator testing and the influence of~     defibrillation testing on the efficacy of clinical shocks.~      The trial will test the hypothesis that implantable cardioverter defibrillator (ICD)~     implantation without defibrillation testing (DT) is non-inferior to implantation with testing~     against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic~     death.~      It will also test the hypothesis, that defibrillation testing increases the peri-operative~     (30 days) complication rate of ICD implantation.~   "
210884|NCT00800371|"~     Juvenile idiopathic arthritis (JIA) may progress asymptomatically leading to joint~     destruction despite treatment.~      The aim of the observational study is to describe patients with silent arthritis comparing~     symptoms, clinical findings with results of ultrasound and magnetic resonance imaging (MRI).~   "
210885|NCT00800358|"~     The purpose of this study is to determine whether oral paricalcitol is safer and more~     efficacious compared to oral calcitriol in the treatment of hyperparathyroidism in chronic~     kidney disease patients undergoing dialysis.~   "
210886|NCT00800345|"~     This is a Phase 1, dose-escalation study in female patients with recurrent or persistent~     gynecologic tumors.~   "
210887|NCT00800332|"~     The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve~     allergy symptoms in patients with house dust mite allergy. The active treatment will be~     compared against placebo.~   "
210888|NCT00800319|"~     The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of~     RDC-0313 following oral administration.~   "
210889|NCT00800306|"~     The present study was conducted as a prospective, randomized, controlled study to:~        -  investigate the effects of a combination of levosimendan and inhaled nitric oxide on~          systemic hemodynamics and microcirculation in patients with catecholamine-dependent~          septic shock;~        -  test the hypothesis that levosimendan plus inhaled nitric oxide may be effective in~          restoring microvascular function in septic shock.~   "
210890|NCT00800293|"~     The purpose of this study was to compare the relative vasoconstrictive effects of test and~     reference topical augmented betamethasone dipropionate augmented 0.05% cream in healthy,~     female subjects.~   "
210891|NCT00800280|"~     The purpose of this study is to estimate the effects of multiple doses of cimetidine on the~     pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability~     of PD 0332334 when co-administered with cimetidine.~   "
210892|NCT00800267|"~     Safety and efficacy study comparing between fixed combination latanoprost-timolol and its~     component parts.~   "
210895|NCT00800228|"~     The purpose of this study is to test the hypothesis that blood pressure sensitivity to high~     sodium intake in healthy humans is characterized by increased urinary excretion of two~     endogenous sodium pump inhibitors, marinobufagenin (MBG), and ouabain-like compound (OLC).~     The study also tests the hypothesis that women who breathe slowly and have high resting end~     tidal CO2 at rest are more likely to have low plasma renin activity and sodium sensitivity of~     blood pressure than those who breathe more rapidly and maintain lower end tidal CO2.~   "
210896|NCT00800215|"~     The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given~     as iv infusions compared with oral administration of the same dose strengths in subjects who~     were receiving oral SPM 927 for partial seizures with or without secondary generalization.~      Trial procedures will include medical history update, physical/ neurological exams, ECGs,~     blood /urine sample collections and seizure diary completion.~      Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM~     927.~   "
210897|NCT00800202|"~     This study will assess the efficacy and safety of Avastin combined with first li ne~     paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with~     non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two~     cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks~     combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a~     maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks~     combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is~     until disease prog ression, and the target sample size is 100-500 individuals.~   "
210898|NCT00800189|"~     The purpose of this study is to determine if an alternative imaging protocol done at the time~     of radiotherapy treatments for patients with breast cancer can improve accuracy in patient~     set-up.~   "
210899|NCT00800176|"~     This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of~     RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be~     randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg~     po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take~     their usual dose of metformin throughout the study.The anticipated time on study treatment is~     <=3 months~   "
210900|NCT00800163|"~     The investigators prospectively determined the impact on median door-to-balloon time of a~     protocol mandating (1) emergency department physician activation of the catheterization lab~     and (2) immediate transfer of the patient to an immediately available catheterization lab by~     an in-house transfer team consisting of an emergency department nurse, a critical care unit~     nurse, and a chest pain unit nurse.~   "
210901|NCT00800150|"~     RATIONALE: Giving total marrow and total lymph node irradiation together with low doses of~     chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It~     may also stop the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect).~      PURPOSE: This phase I trial is studying the side effects and best dose of total marrow and~     total lymph node irradiation when given together with fludarabine and melphalan followed by~     donor stem cell transplant in treating patients with advanced hematological cancer that has~     not responded to treatment.~   "
210902|NCT00800137|"~     Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on~     chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation~     related to stopping oral anti-coagulant therapy is currently managed by using bridging~     heparin therapy in patients with moderate to high risk of blood clot formation. There is a~     substantial risk of bleeding in the pocket where the device is situated (pocket~     hematoma)related to bridging therapy. The purpose of this study is to compare the current~     standard of care of bridging with heparin to an experimental strategy of continuing coumadin~     therapy in higher risk patients undergoing device surgery, with the hypothesis being that the~     continued oral anti-coagulation group will have a lower pocket hematoma rate as compared to~     the bridging with heparin group.~   "
210903|NCT00800124|"~     The objective is to study the overall frequency and cumulative rate (during one year) of~     clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in~     all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare~     this to the group of patients receiving prosthetic implants and further find out if there is~     a difference between the non-cemented and cemented groups.~      Between the same prosthetic groups, the investigators want to study the overall frequency of~     in-hospital subclinical organ damage and dysfunction of myocardium, liver and lungs, using~     biochemical plasma markers. Finally, the investigators want to perform perioperative cost~     benefit calculations and out of hospital quality of life analysis between the surgical~     groups.~   "
210904|NCT00800111|"~     Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the~     diseased endothelial cell layer of the patient's cornea. This technique offers many~     advantages compared with traditional full-thickness cornea transplants. Patients experience~     minimal change in glasses prescription and usually recover useful vision within weeks. Visual~     fluctuations are minimal during the healing process. The patient's cornea remains~     structurally intact and is more resistant to injury.~      Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007,~     the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold~     (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10~     years old, and little is known about long term outcomes. Endothelial keratoplasty candidates~     at our center are invited to participate in an open enrollment, prospective study of the~     long-term outcomes of this procedure.~   "
210905|NCT00800098|"~     Arthritis Relief Plus (ARP) Cream is a natural, herbal cream that has been shown to provide~     pain relief and decreased stiffness. Anecdotal reports suggest that pain may continue to be~     reduced months after cream use is stopped, indicating that there could be some~     disease-modifying effects of the cream. The purpose of this study is to test the claim that~     the ARP cream can provide long-term pain relief to osteoarthritis patients after only a short~     period of use. The study will also try to determine whether the pain relief is accompanied~     with any measurable indications that the progression of osteoarthritis has slowed or halted~   "
210906|NCT00800085|"~     This study will establish criteria indicating short-term loss of beta cell mass and therefore~     accelerated progression towards type 1 diabetes.~   "
210908|NCT00800059|"~     The investigators hypothesize that conformal radiation will allow the administration of~     higher doses of external beam radiation to marrow based malignancies than total body~     irradiation (TBI)without increasing the toxicity to normal tissues beyond that induced by~     TBI. Further,the investigators hypothesize that this will result in an improvement in disease~     response and disease control for patients with multiple myeloma. This is a dose escalation~     study of TMI with the primary objective of determining the maximum tolerated dose of TMI when~     followed by aHSCT in patients with relapsed or refractory multiple myeloma.~   "
210909|NCT00800046|"~     Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of~     mitral valve regurgitation through subvalvular mitral repair.~      Purpose: To demonstrate the safety, feasibility and potential efficacy of using the~     AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular~     mitral repair.~   "
210910|NCT00800033|"~     The investigators specific objective is to determine the effectiveness of a pulse-based diet~     combined with an exercise training program for reducing the risk of metabolic syndrome in~     older adults. The metabolic syndrome is a cluster of risk factors that predispose one to the~     development of diabetes and cardiovascular disease. These risk factors include increased~     abdominal obesity, high blood triglyceride levels, low blood high-density lipoproteins, high~     blood pressure, high blood glucose and insulin levels, and increased inflammation. The~     investigators hypothesize that a pulse-based diet combined with exercise training will be~     very effective for reducing the risks of the metabolic syndrome because each intervention~     acts on different components of the metabolic syndrome.~      The design will involve a randomized single-blind cross-over for the pulse-based diet, and a~     single blind randomized parallel group assignment for the exercise-based intervention. 100~     subjects will be randomized to receive the pulse-based diet or their regular diet for 2~     months and then cross-over to receive the opposite diet for 2 months, separated by a~     one-month wash out. Subjects will be further randomized to exercise or exercise placebo~     groups for the duration of the trial (i.e. 5 months). The exercise intervention will involve~     aerobic training as this is most effective for reducing metabolic syndrome risk.~      Dependent variables will be measured at 4 time points: baseline, after the first 2-month~     diet, before the second 2-month diet (i.e. after the washout) and at the end of the second~     2-month diet. These variables will include: Serum triglycerides, high density lipoproteins,~     C-reactive protein (as an inflammatory marker), glucose, and insulin, trunk body fat, and~     blood pressure. A composite metabolic syndrome score will be determined by converting each of~     these variables into Z-scores and determining the mean of these Z-scores. Secondary variables~     will include other serum lipids, including low density lipoproteins and total cholesterol.~   "
210911|NCT00800007|"~     The purpose of this study is to evaluate the safety, immunogenicity, and antiviral effects of~     multiple intravenous doses of ANZ-521 in patients with chronic Hepatitis C virus.~   "
210912|NCT00799994|"~     A study to determine whether a patient's range of vision test results improve after their eye~     pressure is lowered by 30% or more by testing on a new machine called the Accumap and how to~     learn how much the Accumap's results change from one test to another within the same person.~      The investigators believe that Multifocal VEP readings (Accumap)(and therefore visual~     function and ganglion cell function) improve after acutely lowering intraocular pressure.~   "
210913|NCT00799968|"~     Comparative trials of urokinase (UK) for 12 hours（UK-12h）or 24 hours (UK-24h) have produced~     similar results in acute pulmonary thromboembolism (PTE) thrombolysis. It is unclear whether~     the infusion time can be reduced further. The aim of this study was to investigate the~     efficacy and safety of weight adjusted dosage of UK-2h (20 000 IU/Kg) regime with the Uk-12h~     regime in selected patients with PTE in Chinese population.~   "
210914|NCT00799955|"~     Summary Brief Summary Standard care for pain relief after cesarean delivery is spinal~     morphine. Spinal morphine may be unsuitable for patients having general anesthetic or prior~     morphine-related side effects and can be less effective in patients with morphine tolerance.~     An alternative is a TAP block where local anesthetic is deposited between the abdominal~     muscles consequently numbing the area and providing pain relief. The investigators believe a~     TAP block will provide equivalent pain relief to spinal morphine.~   "
210915|NCT00799942|"~     The purpose of this study is to investigate the long-term safety, tolerability and efficacy~     of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In~     addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus~     will be included.~   "
210916|NCT00799929|"~     The purpose of this study is to compare two different in vitro fertilization (IVF)~     treatments: conventional IVF protocol and minimal stimulation IVF protocol, in terms of~     success rates, stress of treatment, drug-related side effects, multiple pregnancies and cost~     of treatment.~   "
210917|NCT00799916|"~     Fluid resuscitation of severe sepsis may consist of natural or artificial colloids or~     crystalloids. There is no evidence-based support for one type of fluid over another.~      The investigators hypothesis is that fluid resuscitation with Voluven® is advantageous to~     normal saline solution to improve sublingual microcirculation.~   "
210918|NCT00799903|"~     This study will test whether darapladib can safely lower the chances of having a~     cardiovascular event (such as a heart attack or stroke) in people with coronary heart~     disease.~   "
210919|NCT00799890|"~     The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG)~     treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more~     effective than an oral placebo treatment regarding following parameters: increase in brain~     atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of~     the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in~     patients with MS.~   "
210920|NCT00799877|"~     The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients~     with Chronic Plaque Psoriasis (Ps).~   "
210921|NCT00799864|"~     The purpose of this study is to evaluate the pharmacokinetics, safety and effectiveness of~     rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an~     investigator-selected background regimen containing 2 nucleoside reverse transcriptase~     inhibitors (NRTIs) (zidovudine [AZT]/lamivudine [3TC] or abacavir [ABC]/3TC) in~     antiretroviral (ARV) treatment.~   "
210922|NCT00799851|"~     Compare VBL and cyanoacrylate injection (CI) in the treatment of EV in patients with advanced~     liver disease regarding eradication, bleeding, mortality, complication and recurrence rates.~   "
210923|NCT00799838|"~     The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia,~     edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated~     to amoxicillin.~   "
210924|NCT00799825|"~     This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV~     vaccine GSK580299 in female subjects who took part in study 580299/008 and received the~     control vaccine (Hepatitis A vaccine).~   "
210937|NCT00799656|"~     The primary objective of this study is to assess the efficacy of ataciguat versus placebo in~     reducing pain intensity in patients with neuropathic pain.~      The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.~   "
210926|NCT00799799|"~     AML patients with de-novo or secondary disease with age greater than 18 years not eligible~     for stem cell transplantation for medical contraindications, lack of donor or lack of stem~     cells,are eligible. Leukemias other than AML and M3 FAB subtype will be excluded from the~     study. Immunosuppressive chemotherapy prior to NK cell infusion will include: fludarabine and~     cyclophosphamide 4g/m2 (Flu/Cy). The therapy will be administered over 6 days on inpatient~     basis. Haploidentical NK cells will be selected from a steady-state large volume~     leukapheresis product from a suitable KIR ligand incompatible donor. Donor-recipients pairs~     will be selected on the basis of known KIR ligands. In particular, haploidentical donors will~     be included if present at least one allele mismatch at a class I locus among the following~     ones: HLA-C alleles with Asn77-Lys80, HLA-C alleles with Ser77-Asn80, HLA-Bw4 alleles.~     Immunomagnetic enrichment of NK cells will follow two subsequent steps: 1) depletion of CD3+~     T cells followed by 2) positive selection of CD56+ NK cells. Contaminating CD3+ T cells will~     be carefully evaluated.~   "
210927|NCT00799786|"~     The workshop is a 6-week online workshop for caregivers of people with traumatic brain~     injury, post traumatic stress disorder, or dementia. It is being conducted jointly by the~     Stanford Patient Education Research Center and the VA Greater Los Angeles Healthcare System~     and is supported by a grant from the Department of Veterans Affairs, Patient Care Services,~     Office of Care Management and Social Work.~      The goal of the study is to determine whether an online caregiver education and support~     workshop can have lasting beneficial effects in helping caregivers improve their~     self-management of health skills, stress, and improve their caregiving abilities.~   "
210928|NCT00799773|"~     Thrombotic thrombocytopenic purpura (TTP) is a rare disorder that causes blood clots to form~     in blood vessels. The main treatment for TTP is plasma exchange, in which affected patients~     receive transfusions of plasma, the liquid part of blood, from healthy donors. This study~     will examine the effectiveness of an antibody, rituximab, in combination with plasma~     exchange, at improving the immune response in people with TTP and decreasing the recurrence~     of TTP.~   "
210929|NCT00799760|"~     In order to prevent the high mortality due to an hypothetic pandemic caused by a newly~     emerging influenza A virus, antiviral drugs are seen as essential requirements for control of~     initial influenza outbreaks.Two antivirals are available for the treatment oseltamivir and~     zanamivir. Emergence of Oseltamivir resistance has been recently reported. . It appeared~     opportune to assess the efficacy and safety of biotherapy of neuraminidase inhibitors ,will~     be investigated by a randomized, placebo controlled, double blind study in France, during the~     next winter season . This study will be conducted in 300 centres of primary care with 900~     adults with a virologically suspected influenza A infection. Individuals will be randomized~     to 1 of the 3 treatment groups: oseltamivir +zanamivir, or oseltamivir+placebo or placebo~     +zanamivir.The primary judgment criteria will be the proportion of patients with negative RT~     PCR negative in nasal secretions at Day 2.~   "
210930|NCT00799747|"~     The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when~     given as single oral ascending doses to Japanese healthy male volunters. This will be done by~     comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption,~     distrubution and disappearance of AZD4017 in the body. Information about plasma~     concentrations of AZD4017 vs time after dose intake will also be collected. The future~     indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.~   "
210931|NCT00799734|"~     The objective of this study is to evaluate whether a Chinese medicine formula (Erxian~     Decoction，EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile~     and bone turn-over.~   "
210932|NCT00799721|"~     VLBW infants are at risk of developing retinopathy of prematurity (ROP). In the first phase~     of ROP there is a down-regulation of retinal VEGF-expression because of postnatal relative~     hyperoxia, followed by an upregulation of VEGF mediated through retinal hypoxia, which leads~     to pathologic vessel formation. VEGF acts through binding to the specific receptor FLT-1, the~     soluble form sFLT-1 is a specific antagonist of VEGF action. Erythropoietin, given to VLBW~     infants to prevent anemia, may stimulate VEGF-production in neuronal cells. Currently, there~     are no data published about VEGF urine-levels in VLBW infants and it is not known, if urine~     VEGF-levels may serve as a non-invasive marker of ROP-risk. Further shall be investigated, if~     erythropoietin-therapy increases urine VEGF-levels and if there is a correlation with~     ROP-development.~   "
210933|NCT00799708|"~     This study will develop a model for the assessment of successful activation/engagement of~     estrogen receptor beta using salivary biomarkers.~   "
210934|NCT00799695|"~     Diabetic retinopathy is the major cause of blindness in working age Americans, and screening~     for it is cost-effective. There are a quarter of a million people in Southeast Michigan with~     diabetes and pre-diabetes.~      Only half of patients with diabetes are screened regularly for diabetic retinopathy, and this~     proportion has been difficult to increase despite various interventions. Previous research~     focused on HMO patient groups because preventative care was thought to decrease plan costs.~     In addition, it was administratively feasible to track patient-doctor interactions.~      This project builds on published research and institutional experience to determine an~     effective method for increasing the screening rate, in a mobile, non-HMO population. It uses~     administrative methods and information technology infrastructures, such as large scale~     electronic medical records and patient demographic databases, to identify existing patients~     requiring examinations.~      Patients were telephoned by a trained service representative who offered and scheduled firm~     examination appointment times.~      Hypothesis: Annual screening rates for diabetic retinopathy can be substantially improved in~     non-HMO patient groups by directly contacting patients and scheduling firm appointment times.~   "
210935|NCT00799682|"~     The purpose of this study is to determine if there is a difference in the ocular signs and~     symptoms of subjects' eyes using Xalatan® 0.005% versus Travatan Z® 0.004% based on the~     outcome of subject assessment and clinical assessment in patients with Ocular Hypertension or~     Glaucoma with mild to moderate dry eye at baseline in accordance with the Oxford Grading~     Scale.~   "
210936|NCT00799669|"~     RATIONALE: A counseling program that motivates patients to stop smoking and drinking may~     reduce the risk of oral cancer. It is not yet known whether motivational stop smoking~     counseling or motivational stop-smoking and stop drinking counseling is more effective in~     helping patients stop smoking and drinking.~      PURPOSE: This randomized clinical trial is studying how well treatment to stop smoking and~     drinking works in preventing oral cancer in smokers in Puerto Rico.~   "
210938|NCT00799643|"~     Growing evidence over recent years supports a potential role for low grade chronic~     inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we~     will determine whether salsalate, a member of the commonly used Non-Steroidal~     Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2~     diabetes. The study will determine whether salicylates represent a new pharmacological option~     for diabetes management. The study is conducted in two stages. Enrollment in the first stage~     is complete. The primary objective of the first stage was to select a dose of salsalate that~     is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The~     primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood~     sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes~     (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and~     cardiac risk.~   "
210939|NCT00799630|"~     Exercise has numerous health benefits. Nevertheless, when exercise duration is ~45 min or~     longer and intensity moderate to intense, it may induce different troubles, for example:~     hypoglycemia, peripheral and central fatigue, muscle damages, osteoarticular injuries,~     inflammation, cardiovascular dysfunctions. Nutritional loading during exercise may prevent~     and and/or reduce some of these troubles.~      In regard of recent data, we proposed a novel energy drink (NUTRAPERF®) to limit deleterious~     effects of long time exercise in neutral environment (outside temperature between 4 and 25°C)~     and to improve performance. If performance may be increased by this energy drink during long~     time exercise, we proposed that it consumption may also improve performance in short and~     sub-maximal exercise.~      So, the purpose of this study is to investigate the effects of the consumption of this novel~     energy drink on performance during long and short time exercise. Moreover, we studied the~     effects of this consumption on different metabolic parameters (heart rate, oxygen~     consumption, respiratory quotient, ventilation, glycemia, lactatemia), on central and~     peripheral fatigue and on cognitive parameters.~   "
210940|NCT00799617|"~     The Testosterone Trials are a multi-center set of trials involving 12 clinical sites~     geographically distributed across the United States.~      The primary specific aims are to test the hypotheses that testosterone treatment of elderly~     men whose serum testosterone concentrations are unequivocally low - and who have symptoms and~     objectively measured abnormalities in at least one of five areas that could be due to low~     testosterone (physical or sexual function, vitality, cognition, and anemia) - will result in~     more favorable changes in those abnormalities than placebo treatment.~      Two additional trials have been incorporated into the T Trial. Only men enrolled in the T~     Trial are eligible to participate in these trials.~        -  The Cardiovascular Trial will examine if testosterone treatment results in more~          favorable changes in cardiovascular risk factors, compared to placebo.~        -  The Bone Trial will test the hypothesis that testosterone treatment will increase~          volumetric trabecular bone mineral density (vBMD) of the lumbar spine as measured by~          quantitative computed tomography (QCT), compared with placebo treatment.~      A Pharmacokinetic (PK) Study is also being conducted within the context of the interventional~     T Trial. It will examine the variability of the serum testosterone (T) concentration after~     application of testosterone gel or placebo, four months after the start of treatment.~   "
210941|NCT00799604|"~     This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of~     clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of~     blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and~     pharmacokinetics of clevidipine after bolus administration.~   "
210942|NCT00799591|"~     This study will describe clinical outcome and safety data collected prospectively in subjects~     hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment~     with tigecycline, alone or in combination, is planned. Data will be collected only from~     subjects providing informed consent.~   "
210943|NCT00799578|"~     The purpose of this study is to determine whether cysteamine will effectively reduce or~     reverse the biologic markers of steatohepatitis in patients.~   "
210944|NCT00799565|"~     This prospective nation-wide (France) study aims to search for susceptibility genes in MVP~     using a genome wide analysis and comparing results obtained in 1000 patients with MVP and~     1000 non-MVP subjects.~   "
210945|NCT00799552|"~     The purpose of this study is to compare the safety and efficacy of RX-10045 to placebo for~     the treatment of the signs and symptoms of dry eye.~   "
210946|NCT00799539|"~     The primary reason for this study is to further assess safety and efficacy data of the~     bortezomib/melphalan/prednisone (BMP) regimen in previously untreated and transplant~     ineligible multiple myeloma patients~   "
210947|NCT00799526|"~     The purpose of this study is to investigate the safety and efficacy of human conjunctival~     epithelial autologous cultivated ex vivo for reconstruction of the ocular surface in patients~     with symblepharon.~   "
210948|NCT00799513|"~     This phase II multi-institutional trial will explore the safety and efficacy of lenalidomide~     monotherapy given as maintenance therapy following salvage chemo-immunotherapy in patients~     with relapsed or refractory chemosensitive diffuse large B-cell lymphoma~   "
210949|NCT00799500|"~     Interventional study to assess the effect of early detection and treatment of bacterial~     vaginosis in pregnancy on preterm delivery rate.~   "
210950|NCT00799487|"~     The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate~     HCl), is safe and effective in improving academic performance and behavior in children with~     Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.~   "
210951|NCT00799474|"~     This research focuses on men who have sex with men (MSM) who are at higher risk of anal~     cancer. The survey will evaluate their beliefs about anal and oral cancer, their knowledge~     about role of human papillomavirus (HPV) infection in these cancers, and their knowledge of~     HPV vaccination and anal Pap smears. Approximately 12% of subjects will be HIV-positive.~   "
210952|NCT00799461|"~     RATIONALE: A personalized Internet-based program may help improve fatigue, depression, and~     quality of life in long-term survivors of stem cell transplant. It is not yet known whether~     an Internet-based program is more effective with or without telephone-based problem-solving~     training.~      PURPOSE: This randomized clinical trial is studying how well an Internet-based program works~     with or without telephone-based problem-solving training in helping long-term survivors of~     hematopoietic stem cell transplant cope with late complications~   "
210954|NCT00799435|"~     People with type 2 diabetes experience heart failure more often than do people without~     diabetes. This may be due to increased stiffness in the heart as a result of diabetes. This~     study will examine whether exenatide, a medication used to treat diabetes, may have~     beneficial effects on the heart in people with type 2 diabetes and heart failure.~   "
210955|NCT00799422|"~     The purpose of this study was to investigate contact lens fit, lens parameters, and~     conjunctival staining in a sample of subjects with various contact lens/solution~     combinations.~   "
210956|NCT00799409|"~     The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate~     HCl), is safe and effective in improving academic performance and behavior in children with~     attention deficit hyperactivity disorder (ADHD), when compared to placebo.~   "
210957|NCT00799396|"~     One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or~     clopidogrel. However, studies have shown that not all people respond to these medications.~     The variance in treatment response may be linked to genetics. This study will examine the~     effects of aspirin and clopidogrel in a population whose genes are well known in order to~     determine the role that genes play in treatment responses.~   "
210958|NCT00799383|"~     The purpose of this study is to determine whether calcium and vitamin D supplementation, over~     a nine-month period, optimizes bone mineralization in boys with risperidone-induced~     hyperprolactinemia. We hypothesize that, by the end of the stuy, children in the~     supplementation group will have higher bone mineral density compared to those in the placebo~     group.~   "
210959|NCT00799370|"~     The study analyzes the consequences of weight bearing after an HTO in a population of young~     patient with medial osteoarthritis (immediate weight bearing versus two month weight~     bearing). The two options are usually used so the protocol belongs to the intermediate care~     evaluation category.~      The IKS (International Knee Society) score at one year follow up is the first outcome. The~     aim of the study is to highlight that the option early weight bearing (immediately in~     postoperative) is equal to the option delayed weight bearing.~   "
210960|NCT00799357|"~     A variety of pre-intubation clinical screening tests have been advocated to predict difficult~     laryngoscopy, but their usefulness is limited in emergency department, intensive care unit,~     pre-hospital and combat settings. Patients in these settings are often confused, lethargic,~     obtunded, uncooperative and common screening tests for difficult laryngoscopy cannot be~     applied in a large number of emergency intubations. In the recent past, there has been~     growing interest in upper airway ultrasound. The purpose of this study is to assess the~     utility of bedside ultrasound to predict difficult airway in patients requiring emergency~     intubation.~   "
210961|NCT00799344|"~     To address early vessel healing and thrombus formation after deployment of three distinct~     groups of stents~   "
210962|NCT00799331|"~     The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses~     of AZD5985 in healthy male volunteers~   "
210963|NCT00799305|"~     The aim of the study is to assess the correlation between airflow limitation, perception of~     dyspnea and functional capacity with anatomic changes in pulmonary structure as seen on High~     Resolution CT in COPD patients.~   "
210964|NCT00799292|"~     Vasoconstrictive agents are increasingly being used in order to decrease blood loss during~     vaginal hysterectomy. The first reported study of the use of a vasoconstrictive agent for~     this purpose was on the use of epinephrine injected intracervically preoperatively by~     England, et. al. They demonstrated a significant decrease in the amount of blood lost during~     the surgery but also demonstrated a significant increase in the risk of post-operative~     infections, most frequently a vaginal cuff cellulitis requiring antibiotic treatment. Recent~     studies using vasopressin as the vasoconstrictive agent have also found the same significant~     decrease in blood loss while not demonstrating a difference in the rate of post-operative~     infections. The more recent studies by Speer and Unger , and Kammerer-Doak, et.al. were~     larger, better designed studies and are considered more credible. More surgeons are therefore~     injecting vasopressin intracervically preoperatively.~      Some surgeons believe that the injection of vasopressin intracervically prior to the initial~     incision of a vaginal hysterectomy effects surgical plains and therefore makes the surgical~     dissection more difficult. This is thought to possibly both add to operative time and~     increase the rate of complications. The aforementioned studies used the injection of saline~     as a control for the injection of vasopressin or epinephrine. To date, no study has compared~     the use of vasopressin versus no injection in a controlled, randomized manner. We do not know~     if the injection of saline intracervically may actually increase the amount of bleeding over~     the baseline and therefore the decreased blood loss caused by the injection of vasopressin my~     actually be overestimated.~      We propose to compare the effects of injecting vasopressin intracervically preoperatively~     versus no preoperative medication. We will not only evaluate the amount of operative blood~     loss, but also compare operative time and complication rates.~   "
210965|NCT00799279|"~     The aim of this study is to determine if providing smokers identified in family doctors~     offices with follow-up counselling enhances their success with quitting and the number of~     health professionals helping patients with quitting. Six to eight family medicine clinics~     will be involved in the study. We will compare the frequency of addressing smoking with~     patients and the proportion of smokers who are successful with quitting 16-weeks following~     the clinic appointment between practices. It is hypothesized that the addition of follow-up~     counseling to a multi-component smoking cessation intervention will improve smoking outcomes.~   "
210966|NCT00799266|"~     This study is designed to evaluate the efficacy and safety of zoledronic acid compared to~     placebo in osteoporotic children and adolescents treated with glucocorticoids~   "
210967|NCT00799240|"~     This study will compare the rate of chemotherapy: pemetrexed and cisplatin compared with the~     combination of pemetrexed/cisplatin with MK-0646. The other purposes are to determine how~     long we can control the cancer growth and toxicity and safety of the combination. Laboratory~     research with the tumor tissue and blood obtained will be done to assess IGF-1R expression~     and related markers and correlate with response and survival.~   "
210968|NCT00799227|"~     The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in~     the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be~     followed for 26 weeks.~   "
210979|NCT00799084|"~     To improve the management of symptoms, patients with cancer undergoing chemotherapy will be~     monitored using an automated telephone system to record the severity of 15 prevalent symptoms~     for up to 8 consecutive weeks. Outcomes include; significant reduction in symptom severity~     and improvement in health states.~   "
210980|NCT00799071|"~     The purpose of this study is to find a dose for a twice daily regimen for posaconazole (PSZ)~     as prophylactic treatment in children with CGD, based on the PSZ trough level.~   "
210981|NCT00799058|"~     A Multi-Center, Randomized, Double-Blind, PlaceboControlled Phase 3 Safety and Effectiveness~     Trial of a Vaginal Matrix Ring with Dapivirine for the Prevention of HIV-1 Infection in Women~   "
210982|NCT00799045|"~     The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine~     headache episodes following transcatheter ASD closure.~   "
210969|NCT00799214|"~     Bacterial vaginosis (BV), the world's most common vaginal infection, continues to cost~     patients time, energy, comfort and money. BV is associated with increased incidence of~     sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour,~     post-surgical infections, and endometritis. Current treatment for those women symptomatic for~     BV includes both oral and intravaginal antibiotics, such as metronidazole, which have success~     rates of 70-80 % at 1 month after treatment. These treatments also have high recurrence rates~     (49-66 % at one year after treatment) and side effects (10-20 % of women) that include~     secondary vaginal infection with candida. Intravaginal boric acid has been used for >100~     years for the treatment of vaginal infections and is quite commonly prescribed today as a~     treatment for BV. It is cheap, easily accessible, easy to use, and is an effective treatment~     of other vaginal infections, such as candida. To date, there are no clinical trials studying~     the effectiveness of boric acid in the treatment of BV.~      The objective of this study was to determine whether intravaginal BA is comparable to~     standard treatment, metronidazole, for the cure of BV in symptomatic women.~      Our research question is: Among women 16-50 years old symptomatic with BV is intravaginal~     treatment with BA non-inferior to metronidazole to achieve a Nugent score <7 (cure) by day~     17.~      Hypothesis: H0: BA proportion of women cured < metronidazole proportion of women cured - 10%.~   "
210970|NCT00799201|"~     The purpose of this study is to determine if enteral naloxone is more effective than a~     traditional bowel regimen in the prevention and treatment of constipation and impaired~     gastric motility in critically ill trauma patients.~   "
210971|NCT00799188|"~     Heart transplant is a recognized therapeutic strategy in refractory heart failure. Its~     success is however hampered by severe cancer occurrence and recurrence. The new m-tor~     inhibiting drugs Sirolimus and Everolimus have shown potential for reducing the incidence of~     cancer in animal models. They are potent immunosuppressant, antiproliferative and~     antiangiogenic drugs. This open labelled randomized multicenter study aims at evaluating the~     beneficial antineoplastic effect of Everolimus in 159 heart transplant patients suffering of~     recurrent skin cancer. Primary objective is to demonstrate a reduction in the number of new~     skin cancers. Secondary end point will be time of recurrence, incidence of non skin cancer,~     graft function following switch (including death), renal function evolution following~     calcineurin inhibitors reduction or withdrawal, Everolimus tolerance profile, schemes of~     calcineurin inhibitors reduction management in centers.~   "
210972|NCT00799175|"~     The primary aim of this study is to evaluate if intra- and postoperative administration of~     ropivacaine, ketorolac and epinephrine into the operating field would affect morphine~     consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an~     attempt to assess the safety of this technique, knee function and patient satisfaction scores~     are assessed up to 3 months after surgery.~   "
210973|NCT00799162|"~     The purpose of this study is to determine if dynamic psychophysical testing along with~     genetic screening will allow to identify pre-operatively women who will suffer severe acute~     pain post-operatively and the subset who may experience chronic pain following cesarean~     section.~   "
210974|NCT00799149|"~     To determine that when administered as part of a multimodal analgesic regimen, use of the new~     COX-2 antagonist etoricoxib (120 mg/day, per os) is more effective in improving postoperative~     pain management after knee arthroscopy than gabapentin (1.2 g/day, per os).~   "
210975|NCT00799136|"~     No standard regimen currently exists for the treatment of AIDS-related lymphoma. Based on the~     encouraging NCI results with DA-EPOCH, the US AIDS Malignancy Consortium is currently~     administering a phase II randomized protocol comparing EPOCH with sequential versus~     concurrent rituximab (AMC protocol 034). In this AMC trial, the decision to co-administer~     cART is left to the discretion of the treating physician and the patient. While the AMC phase~     II study may establish an acceptable chemotherapy regimen suitable for further study in a~     phase III randomized trial, the results will not address adherence, pharmacokinetic~     interactions or the role of cART in AIDS-related lymphoma. The contribution of cART to the~     anti-lymphoma efficacy of any regimen needs to be formally studied. Our proposed trial to~     demonstrate the feasibility of co-administering cART with chemotherapy would justify the use~     of combined therapy in future AMC/International phase III protocols.~   "
210976|NCT00799123|"~     The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings~     in VLBW infants. The investigators hypothesize that high urine NT-proBNP concentrations are~     associated with a hemodynamically significant ductus arteriosus. The investigators also~     hypothesized that new echocardiographic parameters such as isovolumic relaxation time~     (IVRT)is useful for the prediction of ductus intervention.~   "
210977|NCT00799110|"~     This research study is evaluating the effect (good and bad) of a dendritic cell/tumor fusion~     vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the~     participants immune system. Another purpose of this study is to determine the type and~     severity of any side effects associated with this new study vaccine. We will also be~     evaluating what effect the vaccine has on the participants cancer. Dendritic cell vaccines~     have already been tested in clinical trials involving participants with many different types~     of cancer. Dendritic cells are powerful immune-stimulating cells that are normally found in~     small amounts in the body and are responsible for immune responses against foreign~     substances that enter the body.~   "
210978|NCT00799097|"~     Chronic rhinosinusitis (CRS) is a common health condition in the United States resulting in~     more than 200,000 surgical procedures annually. The field of rhinology has had two major~     advances which the investigators believe make more accurate prediction of postoperative~     outcome possible thereby offering the potential of reducing the frequency of unsuccessful~     surgical procedures. The first advance is the development of validated disease-specific~     quality of life instruments for measuring outcome of CRS management. The major medical~     societies now recognize disease-specific quality of life as the gold standard for assessing~     outcomes in this disease and for the purposes of this study, the investigators define~     surgical outcome as change in disease-specific quality of life (QOL). The second advance is~     the better understanding of the pathological process resulting in CRS. The previous construct~     defined this disease as anatomic obstruction of the sinuses and their secretions. This was~     thought to be best measured by CT scan which has been the main method of attempting to select~     the best candidates for surgery.~      The investigators hypothesize that utilizing this new conceptual framework, the investigators~     can better predict surgical outcomes. The investigators will examine several preoperative~     factors and their relationship to surgical outcome. The factors to be examined include~     measures of the pathophysiological components of inflammation and anatomic obstruction as~     well as preoperative extent of disease as measured by preoperative disease-specific quality~     of life. The investigators hypothesize that these factors provide complimentary information~     that may be variably expressed in individual CRS patients. Therefore, the investigators~     hypothesize that a novel integration of multiple preoperative factors will form a useful~     predictive model of surgical outcome. Finally this prospective study provides the opportunity~     to add to the field by identifying potentially novel risk factors and comorbidities as well~     as study secondary outcomes of sinus surgery including olfactory function and general health~     related quality of life in a systematic manner.~   "
210984|NCT00799019|"~     This multicenter, immunogenicity surveillance registry employs a prospective, cohort design~     for patients who are using erythropoiesis stimulating agents (ESA)according to normal~     practice consistent with the medical indications. Subjects will be observed for the~     development of immunogenicity and PRCA for up to 3 years. Information on exposure to ESA~     products, ESA product handling and storage, and most recent hemoglobin level will be~     collected quarterly in the case report form. For cases of suspected PRCA, that sera specimen~     will be tested for EPO antibodies at Division of Nephrology, Chulalongkorn University~     Laboratory.~      An Advisory Board (ADB) will periodically review blinded case data for subjects with~     unexplained loss of efficacy (LOE), identify cases of EPO antibody-mediated PRCA and will be~     responsible for data summary and make recommendations related to the incidence rate of PRCA~     associated with S.C. ESA use. The registry will provide no inducement to change therapy and~     will be non-interventional. The primary objective for this study is to estimate the incidence~     of anti-human Erythropoiesis and anti-EPO PRCA, develop in such patients. The diagnosis of~     PRCA by bone marrow biopsy must be prerequisite before the antibody assay. The secondary~     objective is to evaluate the efficacy of ESA for treatment of erythropoiesis deficiency~     anemia. Registry subjects will be adult men and women who are receiving or about to receive~     (within 1 month) a marketed ESA product by the s.c. route of administration at the time of~     enrollment. The marketed ESAs include innovative ESA and biosimilar ESA. Potential subjects~     will only be enrolled if they have been receiving an Erythropoiesis product for less than 1~     year. Cases of EPO antibody-mediated PRCA will be determined by the clinical presence of~     essential criteria of unexplained LOE, administration of ESA product, bone marrow biopsy~     diagnosis of PRCA, and presence of EPO antibody. The sera of patients who meet all criteria~     will be assayed for neutralization.~   "
210985|NCT00799006|"~     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The~     purpose of this study is to characterize the safety, tolerability, pharmacokinetics and~     pharmacodynamics following a single oral dose.~   "
210986|NCT00798993|"~     This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured~     exercise program on the exercise capacity and quality of life of haemodialysis patients with~     25 hydroxyvitamin D insufficiency.~   "
210987|NCT00798980|"~     In this non-interventional study we investigate the nulliparous women individual evaluation~     of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.~   "
210988|NCT00798967|"~     Teduglutide is an investigative medicine being evaluated as a possible treatment for people~     with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar~     to a protein the body makes. When people have SBS, their bodies do not make enough of the~     protein and they have trouble getting nutrients and fluids from the food they eat and drink.~     This study was designed to provide evidence of efficacy, safety, and tolerability of~     teduglutide 0.05 mg/kg daily in SBS subjects.~   "
210989|NCT00798954|"~     The use of DES have not diminished the need of improved treatment strategies , especially the~     treatment of bifurcation lesions still leave much to be clarified. Particularly, for~     bifurcation lesions where stenting the main branch could result in an obstruction of a vital~     side branch, many reports have been about using 2 drug-eluting stents. Resulting in less than~     favorable, target lesion revascularization (TLR) rates, with 10-15% for main branch and~     11-40% for side branch.~      In Japan, the PERFECT multi-center registry evaluated outcomes of single stenting plus~     kissing balloon technique after Directional Coronary Atherectomy (DCA) removal of tissue~     plaques. TLR rates for both main branch and side branch were a satisfactory 1.3%. However,~     the DCA technique is mainly suitable for proximal coronary artery lesions, and takes skilled~     operators.~      For the treatment of relatively distal bifurcation lesions, where first POBA is performed,~     then the lesion is stented, followed by kissing balloon technique to fully expand the side~     branch, is considered a viable treatment. The Toyohashi Heart Center outcomes from August~     2004 for this single stent and kissing ballooning technique, using the sirolimus-eluting~     stent on bifurcation lesions, achieved a satisfactory 5.2% TLR for both main and side~     branches, suggesting that using two stents may not be necessarily the ideal treatment.~      The paclitaxel-eluting stent is expected to become available in Japan from June 2007. This~     stent's cells can be expanded to a maximum of 3.5mm, which should provide a larger lumen~     access for side-branch treatment.~      As such, we developed this study to compare the outcomes of paclitaxel-eluting and~     sirolimus-eluting stents in bifurcation lesions that require side branch dilatation using the~     kissing ballooning technique.~   "
210990|NCT00798941|"~     The purpose of this study is to evaluate family-led interventions for Intensive Care Unit~     (ICU) patients' symptoms (i.e., pain and thirst) that will involve ICU patients' family~     members in the non-pharmacological management of these symptoms. This family involvement may~     help to ameliorate not only patients' symptoms but also the families' symptoms and promote~     family satisfaction with ICU care.~   "
210991|NCT00798915|"~     An intestinal hormone called Glucose-dependent Insulinotropic Polypeptide (GIP) is released~     into the blood immediately after ingestion of a meal and plays an important role in~     regulating blood sugar levels. However, GIP is not active in persons with type 2 diabetes~     mellitus (T2DM) which is also known as adult onset or non-insulin-dependent diabetes. This~     study is being conducted to determine whether a hormone called xenin-25 can restore the~     activity of GIP in persons with T2DM.~   "
210992|NCT00798902|"~     This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as~     compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with~     degenerative disc disease (DDD) at one level from L2-S1.~   "
210993|NCT00798889|"~     The objective of this protocol is to provide SU011248 treatment for patients who have~     participated in a SU011248 protocol and are eligible to enter this protocol~   "
211004|NCT00798746|"~     The purpose of the current study is to assess the role of pyloric drainage procedure on~     altering the reflux effect on the quality of life in patients who underwent esophagectomy.~     Researchers hypothesize that the patients who underwent minimally invasive esophagectomies~     without pyloric drainage experience less reflux symptoms and therefore have a better quality~     of life.~   "
211005|NCT00798733|"~     The purpose of this study is to define the outcomes, both patient based and radiographic, for~     sacral fractures based upon injury pattern, displacement, and treatment. This will aid the~     orthopaedist in determining the best course for those patients with mild to moderate~     displacement. Multiple centers will be included and not asked to change their protocols for~     management. The prospective evaluation will gather specific data points on mechanism of~     injury, displacements, position at union, and disease specific and general health outcomes.~   "
211006|NCT00798720|"~     The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the~     third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy)~     and tolerability of this regimen.~   "
230666|NCT00537264|"~     The aim of this study is to compare a multimedia, computerised approach vs. interviewer~     administration of health-related quality of life (HRQoL) instruments.~   "
210994|NCT00798876|"~     Studies on patterns of how many men get prostate cancer in other countries show that~     environment contributes to the high incidence of prostate cancer in the United States.~     Epidemiology studies suggest that this influence may be reduced by the diet of men at risk of~     getting prostate cancer. Although the exact nature of the effects of diet are not completely~     known, the amount of fat eaten appears to affect the number of men who get prostate cancer.~     The type of fat also seems to matter. Eating more of a type of fat called omega-3~     polyunsaturated fat is associated with decreased prostate cancer risk. Omega-3 fat comes from~     fish and is quite different from the type of fat from animals and vegetables (omega-6 fat).~     Because the exact mechanism of this reduction in prostate cancer risk is not known, no blood~     test indications, called markers, have been discovered that would show the effect working.~      Study doctors designed this study to try to find markers in the blood tests of men who have~     prostate cancer, and to find out if a diet supplemented with omega-3 type fat from fish oil~     helps reduce those markers, hence indicating that it helps reduce the cancer in these men.~     These men will be compared to men with prostate cancer whose diets do not contain the~     fish-oil fat.~      The men chosen will have prostate cancer and be scheduled for operations to have their~     prostate glands removed. They will be chosen randomly to be given the fish-oil diet or a~     regular Western diet for comparison for 4 to 8 weeks. Their blood will be checked at the~     beginning of the diet. After the 4-to-8-week period, they will have their operations. Their~     blood will be checked again and a sample of their removed prostate will be examined to tell~     if the diet had any effect on the cancer and its markers.~   "
210995|NCT00798863|"~     The study addresses a problem that face surgeons who perform key-hole surgery to resect the~     submandibular salivary gland. The problem is the narrow space available around that gland.~     This does not allow for a safe operation. The study aims to evaluate a new, two step~     resection technique, that should overcome this difficulty.~   "
210996|NCT00798850|"~     Intermittent Claudication (IC)is a common condition characterised by pain in the muscles of~     the legs on exertion caused by hardening of the arteries and a reduced blood supply. The~     investigators know that the vast majority of people suffering from this condition remain~     stable and do not deteriorate, and thus in general the viability of legs is not at risk. The~     main aim of treatment, therefore, is to try and improve walking thus reducing the impact this~     problem has on patients life style. There are many methods of management of intermittent~     claudication, but the investigators do not know which produces the best results. This study~     aims to compare the short and medium term outcomes of exercise programmes, percutaneous~     transluminal angioplasty and a combination of the two treatments for patients with~     intermittent claudication.~   "
210997|NCT00798837|"~     This trial uses a type of radiotherapy called intensity modulated radiotherapy (IMRT), which~     is able to deliver the radiation to the prostate while delivering less dose to the~     surrounding normal organs compared with standard 3D conformal radiotherapy presently used at~     the BCCA. This trial will use RapidArc IMRT, which is a new way of delivering IMRT, where the~     radiation dose is delivered in a single rotation of the radiotherapy machine around the~     patient. This new method of delivering IMRT has been shown to be at least as good as~     conventional IMRT at delivering the dose, and takes less time to do so.~      The aim of this study is to deliver a higher radiation dose to the prostate gland than the~     standard treatment while not increasing dose to the normal organs. In this way, it is hoped~     that the likelihood of the cancer coming back will be reduced without causing an increase in~     side-effects.~   "
210998|NCT00798824|"~     This clinical pilot trial is being conducted to learn more about the infant's feeding~     behavior while being fed by indwelling nasogastric tube placement or by intermittent oral~     tube placement.~      Healthy preterm infants who are transitioning from gavage to oral feedings via oral~     intermittent tube insertion may achieve full oral feeds by bottle/breast at an earlier~     gestational age than infants feeding with indwelling tubes and may be ready for earlier~     discharge.~   "
210999|NCT00798811|"~     -  Study No.: KSPNO-S-081 Reduced-dose Craniospinal Radiotherapy Followed by High-dose~          Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk~          Brain Tumor~        -  Study No.: KSPNO-S-082 High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants~          and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce~          Craniospinal Radiation~        -  Study No.: KSPNO-S-083 High-dose Chemotherapy and Autologous Stem Cell Rescue in~          Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate~          Response to Conventional Treatment~   "
211000|NCT00798798|"~     The purpose of this study is to assess whether brief use of an externally implantable tissue~     expansion device following excisional skin cancer surgery will significantly reduce the~     diameter of the final wound defect, and hence the length of the final linear primary closure.~     The secondary objective is to assess the functional benefits, if any, associated with use of~     the tissue expander.~   "
211001|NCT00798785|"~     The present proof of concept study addresses the following specific aims:~      The general objectives of this work are:~        1. To increase and maintain the functional beta-cell mass after islet transplantation under~          a condition of low-dose tacrolimus~        2. To co-investigate the potential of alternative sites for encapsulated beta-cells~   "
211002|NCT00798772|"~     Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability~     to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug~     treatment has improved the prognosis of persons with HIV infection, but is expensive and~     potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV~     infection and increase risk of a poorer prognosis, but the role of micronutrient and~     antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed~     clinical trial aims to assess if supplementation of untreated HIV-infected adults with a~     micronutrient and antioxidant preparation can delay decline in immunity or disease~     progression or start of anti-HIV drug treatment compared with supplementation with standard~     multivitamins. If the findings are positive, the study has implications for health and health~     care savings.~   "
211003|NCT00798759|"~     The purpose of this study is to compare two ophthalmic solutions in patients with open-angle~     glaucoma or ocular hypertension.~   "
211714|NCT00789269|"~     This study will determine if rhubarb will reduced the incidence of pneumonia and improved~     recovery from an acute stroke. The study is designed to look at both infection rate and~     overall recovery and recovery of motor function, for example muscle strength and~     coordination.~   "
211007|NCT00798707|"~     The primary purpose of this study is to compare the antidepressant efficacy and safety of two~     doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder.~     The study will also assess changes in sexual function and general and functional quality of~     life outcomes.~   "
211008|NCT00798694|"~     The purpose of this research study is to determine whether one glaucoma eye drop is less~     likely to cause changes to the surface of the eye (conjunctiva) than another. The~     investigators plan to determine this theory by comparing the results when a patient is using~     two different prostaglandins, Xalatan and Travatan Z. (Both of these drops are presently on~     the market and are approved by the FDA for the treatment of eye pressure). Because this study~     will be masked, the clinician who reviews the study results will not know what study drop~     each patient has been using.~   "
211009|NCT00798681|"~     This is an international prospective randomized multicenter open-label controlled study. The~     primary center will be Fernandes Távora Hospital (Fortaleza, Ceará). The aim of this study is~     to investigate the effects of closed parenteral nutrition systems when compared to open~     parenteral nutrition systems in terms of several clinical outcomes.~   "
211010|NCT00798668|"~     The purpose of this research study is to determine the effects of food supplements and~     strength training on appetite, the amount of energy expended, and body composition.~   "
211011|NCT00798655|"~     The objectives for this study is as follows:~        -  Primary:~             -  To evaluate the progression-free survival of locoregionally advanced (stages~               III/IV) SCCHN patients undergoing postoperative chemoradiotherapy with panitumumab.~        -  Secondary:~             -  To evaluate the overall survival, event-free survival, and toxicities.~             -  To correlate efficacy parameters with 1) EGFR and downstream pathway activation, 2)~               FcyR polymorphisms, and 3) serum cytokine profiles. More specifically, the aim is~               to demonstrate the usefulness of biomarkers (downstream signaling molecules, FcyR~               polymorphisms, or tumor and serum cytokine(s) in predicting progression-free~               survival in patients with SCCHN treated with the above treatment. Specific~               biomarkers that relate to Epidermal Growth Factor Receptor and angiogenesis,~               including EGFR, pEGFR, Src, pMAPK, pSTAT3, pSTAT5, pSTAT1, pAKT, p38, p21, p27,~               PARP, E-cadherin, p-ErbB3, Ki67, VEGF, and IL-8, using reverse phase protein~               microarrays (RPPA) will be tested in baseline archival paraffin-embedded tumor~               tissue. To collect tumor tissue from pretreatment biopsies for cytokine/chemokine~               and immune biomarker studies on tumor tissue. We plan to investigate the expression~               of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis~               biomarkers. In addition, EGFR polymorphisms will be studied in tumor tissue samples~               and serum. Additional studies may be performed in the future. Some of these studies~               may be performed by Amgen.~   "
211012|NCT00798642|"~     The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will~     maintain remission in patients affected by Ulcerative Colitis.~   "
211013|NCT00798629|"~     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune~     response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with metastatic melanoma.~   "
211014|NCT00798616|"~     The purpose of the study is to determine whether corticosteroids are beneficial to children~     with bronchiolitis whose breathing gets better after being given a breathing treatment with~     albuterol.~   "
211015|NCT00798603|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Giving pemetrexed together with~     carboplatin and bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving pemetrexed together with carboplatin~     and bevacizumab works as first-line therapy in treating older patients with stage IIIB or~     stage IV non-small cell lung cancer.~   "
211016|NCT00798590|"~     The goal of this present proposal is to examine the efficacy of GLP-1 administered to control~     blood glucose in critically ill patients.~   "
211017|NCT00798577|"~     The primary objective of this study is to investigate the initial antibiotic effects in the~     treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.~   "
211018|NCT00798564|"~     The overall aim is to explore pathophysiological factors related to airway~     hyperresponsiveness to direct and indirect provocation stimuli in athletes with different~     sport activities, with special focus on epithelial reaction linked to CC16 and to eicosanoid~     related inflammatory response. The investigators also wish to compare indirect testing done~     as hyper osmotic challenge with Mannitol compared to a defined sport specific exercise~     challenge.~   "
211019|NCT00798551|"~     Hypertension is a very common disease, affecting approximately 65 million people in the~     United States. As many as 30 % of people with hypertension, approximately 20 million~     individuals, remain undiagnosed. As many as one third of patients seen in ED were noted to~     have elevated BP readings in prior studies. Approximately 5% of emergency department (ED)~     patients have severely elevated blood pressure. Prior studies suggest that as many as two~     thirds of ED patients with elevated BP can benefit from further therapy or closer clinic~     follow-up. However primary care follow-up after ED discharge with an elevated BP is~     surprisingly low. The purpose of this study is to measure the follow-up rate after the ED~     visit in individuals identified with elevated blood pressure after a brief counseling~     regarding risks of elevated blood pressure.~   "
211049|NCT00798161|"~     The objective of the randomised part of the study is to investigate the efficacy and safety~     of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug~     naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic~     patients with insufficient glycaemic control. For the open-label part of the study the~     objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic~     patients with very poor glycaemic control for 24 weeks~   "
211050|NCT00798148|"~     This trial is studying how well iodine I 131 metaiodobenzylguanidine together with~     combination chemotherapy works in treating patients who are undergoing an autologous~     peripheral stem cell for high risk or relapsed neuroblastoma.~   "
211020|NCT00798538|"~     The purpose of this study is to assess the feasibility, cost and effectiveness of~     interventions designed to integrate buprenorphine treatment for opioid dependence into HIV~     primary care in ten HIV care centers in the U.S.~      In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine~     treatment. Assignments are based on participants' city of residence. In the onsite~     (integrated care) model, participants receive buprenorphine, substance abuse counseling and~     HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site~     model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care~     will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS~     Program, and patients' own HIV providers, respectively. Data is collected from interviews~     with participants, reviews of medical records, and surveys and interviews with clinicians.~   "
211021|NCT00798525|"~     The purpose of this study is to test the hypotheses that argatroban significantly increases~     efficacy and safety of renal replacement therapy measured as life time of haemodialysis~     filters as compared to lepirudin~   "
211022|NCT00798512|"~     The purpose of this study is to detect new ischemic lesions after carotid artery stenting~     (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by~     diffusion-weighted magnetic resonance imaging (DW-MRI), using the endovascular proximal flow~     blockage (Mo.Ma device) for cerebral protection.~   "
211023|NCT00798499|"~     The purpose of this study is to collect reference data in patients with haemophilia. The~     study will also collect and store blood samples for potential future exploratory research in~     the disease area.~   "
211024|NCT00798486|"~     The purpose of this study was to assure that consumers can successfully use the new version~     of A1CNow+ along with revised instructional materials.~   "
211025|NCT00798473|"~     Background:~        -  Up to 30% of children and adolescents with Crohn's disease have decreased bone strength,~          or decrease bone density, called osteopenia.~        -  Bisphosphonates are a group of drugs that have been well studied and found to be~          effective in the treatment of osteopenia in menopausal women.~        -  Zoledronate is a very potent third generation bisphosphonate, that is safe and easy to~          administer, and has been found effective in the treatment of menopausal women with~          osteopenia.~      Hypothesis: The investigators hypothesize that zoledronate can improve bone density in~     children and adolescents with Crohn's disease with osteopenia.~   "
211026|NCT00798460|"~     The purpose of this study is to determine the optimal antiviral treatment for lamivudine~     resistant hepatitis B patients.~   "
211027|NCT00798447|"~     Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3~     PUFA on post-operative inflammatory processes.~   "
211028|NCT00798434|"~     The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at~     unwanted times and has been shown to help patients with overactive bladder syndrome pass~     urine less frequently than before treatment. It is postulated that this drug will also prove~     effective in elderly patients (aged > 65 years) and that the ability to change dose between 4~     and 8mg will allow each patient to have an optimised treatment.~   "
211029|NCT00798421|"~     The purpose of this study is to investigate whether influenza can be reliably transmitted~     from children to susceptible contacts in a health care setting. The goal is to develop a~     transmission that can then be used to assess interventions to prevent transmission~      Research objectives:~      To develop a model to investigate the frequency of influenza transmission from an infected~     child to a susceptible health care worker~      Research Hypotheses:~      Influenza viruses can be transmitted from infected children to exposed health care workers~   "
211030|NCT00798408|"~     We propose to critically evaluate the effects of energy-yielding fluids and solids on acute~     appetite variables, daily food intake, and specific endocrine and metabolic response to food~     in the elderly. The results of these studies will provide further evidence to support that~     nutrition may provide safe and effective non-pharmacological therapies to counter the~     compromised regulation of energy balance experienced by many elderly people.~   "
211031|NCT00798395|"~     This trial is to investigate the effect on next-day driving performance and psychomotor~     performance in healthy volunteers.~   "
211032|NCT00798382|"~     The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of~     normal term infants to two experimental soy-based formulas, relative to a commercially~     available soy-based formula.~   "
211033|NCT00798369|"~     This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the~     management of acute flare in gout patients who are contraindicated to Non-Steroidal~     anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the~     corticosteroid triamcinolone acetonide.~   "
211034|NCT00798356|"~     Studies in the past have shown that yoga could relieve stress which is the most common~     trigger for recurrent episodes of atrial fibrillation. Breathing exercises in yoga are found~     to influence the autonomic nervous system (particularly parasympathetic) and thus reduce~     palpitations. This study hypothesizes that patients with atrial fibrillation might benefit by~     practicing yoga. Yoga may also help to better control heart rate and rhythm when used in~     combination with usual medical management.~   "
211035|NCT00798343|"~     Vaccination is the principal means of combating epidemic and pandemic influenza. As vaccines~     induce relatively strain-specific and short-lived antibody responses, annual immunisation~     with regularly updated vaccine is recommended for seasonal influenza, but would not be~     expected to protect against a pandemic event. In clinical trials among young adults, at least~     two doses of avian influenza H5 or H9 subunit vaccine are needed to induce moderate antibody~     responses. However, studies including older subjects have unexpectedly found that some people~     aged over 65 yrs have pre-vaccination neutralising antibody to influenza H5 and H9~     respectively. These subjects mount a robust antibody response to single dose H5 or H9~     pandemic vaccine, suggesting that they are effectively primed to at least some strains of~     avian influenza.~      This exploratory proposal focuses on those elderly subjects whose immune systems already~     exhibit antibodies to H5 with a goal of investigating the humoral and cellular basis of the~     immune response to seasonal and pandemic vaccination. We will examine neutralising antibody~     responses to a range of human and non-human influenza viruses before and after seasonal and~     pandemic vaccination and evaluate cellular B and T cell immune responses before and after~     pandemic H5 vaccination~   "
211036|NCT00798330|"~     Patients who are preparing to receive chemotherapy are asked to have their teeth cleaned~     before starting treatment as standard of care. This research study is being done to see if~     having dental cleaning increases the chances of bacteria from the mouth getting into the~     blood stream. It is also being done to see if these bacteria can cause blood stream~     infections in people who have a Central Venous Catheter (CVC),often called a port or a~     PICC, placed for giving chemotherapy. It is a well-established fact that we introduce~     bacteria from the mouth into the bloodstream with activities of daily life including chewing,~     flossing and brushing teeth. This introduction of bacteria into the blood stream may cause~     bacteria to stick to the central venous catheter and serve as a source of infection when the~     immune system is weakened by cancer. The purpose of this research study is to see if we can~     find bacteria from mouth in blood that is drawn through the CVC, during, and after a dental~     cleaning procedure. This way, we will be able to assess whether or not this is a potential~     health risk to cancer patients.~   "
211037|NCT00798317|"~     This trial will evaluate the safety and efficacy of microplasmin, administered as an~     intravitreal injection, in subjects with focal vitreomacular adhesion. In previously~     performed clinical trials, some patients treated with intravitreal microplasmin have had~     resolution of their underlying condition, including macular hole closure, without need for~     vitrectomy. This clinical trial is justified because the sponsor believes the potential~     benefits outweigh the potential risks.~   "
211038|NCT00798304|"~     The primary purpose of this study is to evaluate the safety and immunogenicity of an~     investigational meningococcal B vaccine in healthy infants.~   "
211039|NCT00798291|"~     To evaluate whether AN777 with or without exercise affects muscle mass change in elderly~     subjects.~   "
211040|NCT00798278|"~     A great controversy exists about which is the best method to perform the evacuation of the~     collection. The purpose of this study is to evaluate which is the best initial treatment to~     drain complicated parapneumonic empyema (stages II and III) in children: the present study~     raises a hypothesis of equivalence between both arms of treatment (chest drainage plus~     intrapleural urokinase or videothoracoscopic debridement).~   "
211041|NCT00798265|"~     Background:~        -  Human papilloma virus (HPV) is a common sexually transmitted disease. There are more~          than 100 different HPV types, and both males and females can get HPV infection. Most~          people do not have any symptoms when they become infected and are able to get rid of the~          infection on their own. However, they can still become re-infected with the same or a~          different HPV type, and in some people HPV infection persists.~        -  Persistent HPV infection is associated with the development of precancerous lesions and~          cancer. HPV types are classified as either high risk or low risk based on whether their~          persistence will lead to cancer.~        -  Patients who have suppressed immune systems are at a higher risk for HPV-related~          complications. They are more likely to contract multiple HPV types and have more~          persistent infection that can lead to precancerous lesions or cancer, which are then~          difficult to treat and often recur.~        -  A recently approved vaccine for HPV induces immunity to HPV 6, 11, 16, and 18. It was~          shown to be highly effective in preventing infection with these HPV types, and is~          approved for use in females 9 to 26 years of age. However, much less is known about the~          vaccine s ability to induce immunity in males or individuals with suppressed immune~          systems.~      Objectives:~      - To investigate whether the HPV vaccine is safe to give and able to induce immunity in both~     female and male adolescents and young adults with HIV infection compared to healthy,~     HIV-negative persons of the same age.~      Eligibility:~      - Males and females, 12 to 26 years of age, divided into three groups: (1) Healthy and~     HIV-negative, (2) HIV-positive and on antiretroviral therapy, and (3) HIV-positive and not on~     antiretroviral therapy.~      Design:~        -  Before beginning vaccination, participants will have a complete physical examination and~          blood drawn for routine blood tests, special tests of the immune system, antibody tests,~          and an HIV test.~        -  HPV vaccine will be given by injection into the muscle at 0, 2, and 6 months, according~          to the standard vaccination schedule.~        -  Patients with HIV infection will be monitored for a week following the first injection~          to test the level of HIV in the blood 3 days and 5 days after the first injection.~        -  Participants will also be asked to fill out a 10- to 15-minute Web-based survey about~          awareness, health behaviors, and personal choices related to risk factors for HIV, HPV,~          and other sexually transmitted diseases. Participants are not required to fill out the~          survey to receive the vaccine.~        -  The total duration of the study is 4 years. During the first year of the study,~          participants will return for six additional 1-day visits at months 1, 2, 3, 6, 7, and~          12. Participants will return for 1-day visits every 6 months for the remaining 3 years.~   "
211042|NCT00798252|"~     To determine safety and maximum tolerated dose of brivanib alaninate when administered in~     combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel~     chemotherapy to subjects with advanced or metastatic solid tumors~   "
211043|NCT00798239|"~     This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as~     compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with~     degenerative disc disease (DDD) at one level from L2-S1.~   "
211044|NCT00798226|"~     The aim of this study is to prevent asthma and allergies in childhood by supplementation with~     fish oil (n-3 fatty acids) to the mother during pregnancy. Paticipants are mother and~     children participating in the ABC-(Asthma Begins in Childhood)cohort. Mothers are recruited~     during pregnancy and receive supplement with n-3 fatty acids or olive oil (placebo) from week~     24 of gestation to 1 week after delivery. The child is followed with acute and planned visit~     at the research unit and diagnosis of disease is done in the research unit according to~     predefined algorithms.~   "
211045|NCT00798213|"~     Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or~     gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive~     SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in~     participants with AML and participants with ALL. Part 2 of the study will determine the~     activity of SCH 727965 treatment in participants with AML who experienced disease progression~     after standard treatment with gemtuzumab ozogamicin during Part 1.~   "
211046|NCT00798200|"~     This project will create a community based exercise program for well cancer survivors. The~     goal is that the YMCA will gain the competence to work with this unique population in a safe~     and productive manner.~   "
211047|NCT00798187|"~     The goal of this research study is to learn if a support group program is acceptable for~     patients with prostate cancer or patients with breast cancer. Researchers also want to learn~     if the characteristics of the members of the support group program can have an effect on the~     quality of life of other members of the support group program. Support group programs will be~     conducted separately for prostate cancer patients and breast cancer patients.~   "
211048|NCT00798174|"~     When implantable cardiac defibrillators are implanted (ICDs), the defibrillation threshold~     (DFT), of the amount of energy required to effectively terminate life-threatening arrhythmias~     is determined. The device is then programmed to discharge a larger amount of energy in order~     to provide a safety margin. In some patients, the DFT is so high, that an adequate safety~     margin is not programmable. Placement of a defibrillation lead in the azygos vein has been~     found to be helpful in these patients. This goal of this trial is to attempt to quantify the~     reduction in the DFT that results from the~   "
230853|NCT00534794|"~     The purpose of this study is to compare the effects of two marked ocular anti-allergy~     medications in cat sensitive subjects with allergic conjunctivitis.~   "
211051|NCT00798135|"~     Cancer cells need to be able to make new blood vessels in order to keep growing. This is~     called angiogenesis. In a laboratory setting, the drug itraconazole was shown to help stop~     the growth of new blood vessels (anti-angiogenesis). It is hoped that itraconazole will~     prevent new blood vessels from forming in humans too.~      The purpose of this study is to look at how the body processes and breaks down itraconazole~     (called pharmacokinetics). This study will also measure markers in your blood to see if~     itraconazole stops new blood vessels from forming. The safety of itraconazole will also be~     tested to see what effects (good and bad) it has on you and your breast cancer.~   "
211052|NCT00798122|"~     Approximately 600,000 women are treated for acute coronary syndrome (ACS) annually in the US.~     ACS includes heart attack and a milder form called unstable angina. Many of these women have~     angiograms of which 14-39% show no significant coronary artery disease (CAD, cholesterol~     plaque accumulation in arteries of the heart). The remaining majority of women with ACS have~     cholesterol plaque buildup which appears severe enough on angiography to limit blood flow to~     the heart.~      It is difficult to advise women with heart attacks and no major heart artery blockages on~     what to do if chest pain happens again. Additional studies are needed to find out why this~     sort of heart attack happens and to help doctors understand how to treat patients who have~     this problem in the best possible way.~      Some women with heart attacks who have no major blockage in heart arteries have cholesterol~     plaque in the arteries of the heart cannot be seen on angiography but can be seen using a~     newer technique called intravascular ultrasound (IVUS). IVUS involves creating pictures of~     the artery walls using ultrasound (sound waves) from within the artery itself. In some women~     without major heart artery blockage, heart attack is caused by low blood flow due to disease~     of smaller blood vessels which cannot be seen on angiography or IVUS. This problem can be~     found using magnetic resonance imaging (MRI), which can show blood flow to the heart. MRI may~     also be used to show where the heart has been damaged. The pattern of damage could suggest~     that a heart attack in a woman, who has no badly blocked heart arteries, happened for one (or~     more) of these reasons or another reason.~      The Study of Women with ACS and Non-obstructive CAD (SWAN) will use IVUS and MRI to help~     determine the reasons for heart attacks in women with no major blockages in heart arteries.~   "
211053|NCT00798109|"~     Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %,~     involving both genetic and environmental risk factors. Prospective studies have shown that~     heavy use of cannabis in adolescence moderately increases the risk of developing~     schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in~     patients with schizophrenia has a deleterious impact on the clinical outcome of~     schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health~     problem for which there is no empirically validated treatment. We are presently studying the~     efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.~   "
211054|NCT00798096|"~     Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19~     patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients~     exhibit a response at Week 8 or later in the study. All enrolled patients will be treated~     with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor~     measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans~     and physical exam of all disease-involved areas every 8 weeks until progression. Safety will~     be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All~     patients will have a follow-up visit 30 days following last study drug treatment. Blood~     samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol~     defined intervals.~   "
211055|NCT00798083|"~     To investigate if topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic~     lecitine organogel (AKL in PLO gel) can improve management of neuropathic pain from radiation~     skin reactions adjunctively or better than standard treatment.~   "
211056|NCT00798070|"~     This is an adjuvant, open, prospective, randomized study to compare:~      A. Individually tailored and two weekly dosed epirubicin + cyclophosphamide followed by a~     three weeks break followed by biweekly and tailored docetaxel (dtEC→dtT) given every second~     week, to~      B. Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by~     fixed dosed and three weekly docetaxel (FEC→T).~      Patients with primary node-positive or high risk lymph node negative breast cancer will be~     eligible for the study.~      The primary objective of the phase 3 study is to compare breast cancer relapse-free survival~     (BCRFS) between the dtEC→dtT and FE100C→T. To detect a five-year BCRFS difference of 0.710 to~     0.790 about 1000 patients per arm will be needed. They will be recruited during four years~     and followed another two years for breast cancer events.~      Secondary objectives are to compare~        1. Distant disease-free survival (DDFS)~        2. Event-free survival and~        3. Overall survival~        4. Health-related quality of life and toxicity analyses according to CTC~        5. Outcome in relation to tumour biological factors and polymorphism patterns~             1. RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene~               expression profiling comparing A vs B arm~             2. RFS with receptor positive disease (analyzed in the local laboratories as described~               in the CRFs and also analyzed as continuous variables) in the comparison between~               the A- and B- arms.~             3. RFS with high and low proliferation, respectively, (analyzed in the local~               laboratories as described in the CRFs and also analyzed as a continuous variable,~               or centrally analyzed), in the comparison between the A- and B-arms.~             4. RFS in relation to HER-2/neu status (analyzed in the local laboratories as~               described in the CRFs) in the primary cancers in the comparison between the A- and~               B-arms and analyzed whether trastuzumab was given in sequence or concurrently.~             5. RFS analyzed in relation to other molecular markers (e.g. gene expression~               profiling/ sequencing) in the primary cancers and SNPs signatures in normal DNA~               (related to toxicities for EC/FEC and docetaxel components, respectively, and given~               dose levels and outcome in relation to these factors and in relation QoL) to~               outcome per arm.~             6. RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein~               in the comparison between the A- and B-arms.~      Tumour tissue will be obtained and stored for studies of prognostication and therapy~     prediction.~      Last patient randomized was September 2011.~   "
211057|NCT00798057|"~     The purpose of this study is to collect information from medical records to see what effects~     proton beam radiation has on pituitary tumors and analyze possible side effects.~   "
211058|NCT00798044|"~     The purpose of the study is to determine if a semi-automated quality improvement system that~     provides addiction counselors with feedback on their average treatment satisfaction and~     therapeutic alliance (as rated by patients currently in treatment) is superior to no feedback~     in 32 community-based outpatient addiction treatment clinics.~   "
211098|NCT00797524|"~     The main objective of this observational study is to characterize and correlate functional~     and structural changes at the retinal level using the Retinal Leakage Analyzer (RLA) and the~     Optical Coherence Tomograph (OCT).~      To show if it is possible to use OCT as an indirect measurement of leakage, this study will~     check, in a primary analysis, for OCT changes between fluorescein leaking and non-leaking~     areas (identified by Retinal Leakage Analyzer).~      As a secondary objective, changes in RLA and OCT over time (between two consecutive visits)~     will be analyzed and characterized.~      The results of this study will be used exclusively for scientific purposes.~   "
211059|NCT00798031|"~     Following the loss of teeth, the alveolar bone formed in response to the eruption of the~     teeth is gradually resorbed by the body. In conventional dental implant therapy, a wide~     safety margin of uninterrupted healing (3-6 months) following placement of the implants is~     used to assure a predictable survival of the implants (on the order of > 90%). In the past~     few years, there have been multiple studies documenting with improved implant surface~     technologies available, that dental implants can be put into function far sooner than~     conventionally thought. The investigators are currently performing recalls on subjects~     treated in a research protocol at the University of Iowa (YAOSS-0001; IRB 200305001). Since~     this initial study, a shortened version of the implant device has been developed and has~     obtained FDA clearance (FDA 510k 063779 clearance letter dated April 27, 2007) for a 4mm~     diameter by 6mm in length dental implant. In a case study the investigators are proposing to~     repeat the same protocol as used in the initial trial with the following exceptions: only~     this one implant type will be used, no bone compression surgical techniques will be used~     (referred to as osteotome indirect sinus lifting). Our initial trial has documented good~     performance with minimal bone loss and a 98.3% cumulative survival rate.~      This will be an open, prospective case-series clinical documentation study to document the~     clinical efficacy of the 4.0mm diameter x 6 mm in length implant (Astra Tech Dental Implant,~     Fixture OsseospeedTM ) in the treatment of subjects missing teeth in the upper jaw. A minimum~     of two but preferably three implants shall be considered for each surgical site. A total of~     20 subjects fulfilling all inclusion criteria will be enrolled. Subjects will have a complete~     diagnostic work-up performed and assessment for eligibility in the study by both a~     Prosthodontist and Surgeon. Subjects will then have the implants placed in an out patient~     basis at the College of Dentistry. The subjects will not wear a conventional removable~     partial during the initial six weeks of healing. At six weeks, an assessment of the implants~     shall be made by the surgical and restorative team and if a set of safety benchmarks are met,~     provisional crowns will be made to place the implants into clinical function (mastication).~     Over the first year, the provisional crowns will be periodically removed and a series of~     clinical measurements and mobility measurements made. At the end of 1 year following~     placement, the permanent crowns or bridgework will be constructed and the subject followed~     annually for another four years (five years total from placement). A total of 15 clinical~     visits are estimated per subject.~   "
211060|NCT00798018|"~     It has been proven that tracheal tube inflated with lidocaine could decrease the~     post-intubation sore throat in nitrous oxide anesthesia. In the study, the investigators~     would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and~     compare the effect of tetracaine, the best mucosal local anesthetics with lidocaine.~   "
211061|NCT00798005|"~     Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs~     due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be~     regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an~     extremity and often causes lifelong disablement from a painful leg. The clinical consequences~     of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in~     the distal limbs.A variety of medical therapies have been investigated for patients with~     PAOD. There is currently no evidence to suggest that any medical therapy is effective for~     patients with rest pain and/or ischemic ulcers.~      Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a~     improvement in clinical and hemodynamic status in patients with severe PAOD~   "
211062|NCT00797992|"~     To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary~     to pathologic myopia (PM-CNV).~   "
211063|NCT00797979|"~     Bone flaps after craniotomy are typically fixed with suture material, mini plates and others~     devices. In some cases, fixation with suture material is not secure as it may result in~     shifting of the bone flap with its dislocation. We will test the safety and efficacy of SKULL~     GRIP a new device for fixation of the bone flap during cranial procedure comparing to~     traditional suture materials.~   "
211064|NCT00797966|"~     Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an~     assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an~     incomplete response to a prospective eight week trial of the same assigned open-label~     marketed ADT.~   "
211065|NCT00797953|"~     The purpose of this study is to determine the anti-angina effect and dose response of T89, a~     2-herb botanical drug product, in patients with chronic stable angina pectoris in the United~     States.~   "
211066|NCT00797940|"~     A Phase II, multi-center, open-label, single-arm study in up to 42 subjects with first~     recurrence or progression of GBM at up to 12 sites in Australia, Europe, Israel, and the~     United States. Subjects will receive intratumoral infusion of PRX321 administered via~     convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60~     mL over 2 to 7 days.~      Primary Objective:~      To evaluate the efficacy (expressed as overall survival at 6 months [OS-6]) of intratumoral~     infusion of PRX321 in subjects with first recurrence or progression of glioblastoma~     multiforme (GBM).~      Secondary Objectives:~      To assess the safety of intratumoral infusion with PRX321 in subjects with recurrent or~     progressive GBM.~      To evaluate objective response rate (ORR), duration of response (DR), overall survival (OS),~     and progression-free survival (PFS).~      Tertiary Objective:~      To evaluate the relationship of observed infusate distribution with clinical and radiological~     responses.~   "
211067|NCT00797927|"~     we aim to examine whether a representative atypical antipsychotic, quetiapine, has different~     effects from conventional antipsychotics on the magnetic resonance spectroscopy (MRS) markers~     in schizophrenia patients.~   "
211068|NCT00797914|"~     The purpose of this study is to evaluate a handheld Colonoscopy Force Monitor(CFM™), a~     push-pull force and torque measuring device, that grips the shaft of the colonoscope and~     wirelessly transmits and records all the forces applied by the endoscopist during~     colonoscopy.~   "
211069|NCT00797901|"~     The purpose of this study was to examine the effect of a new disease management model for~     depression, the Collaborative Depression Management Program (CDMP), designed to improve~     clinical outcomes and increase depression treatment in general medical settings.~   "
211081|NCT00797745|"~     SCH 900518 is a potent oral inhibitor of HCV NS3 protease which disrupts hepatitis C virus~     (HCV) polyprotein processing. SCH 900518, when added to the current standard of care (SOC),~     peginterferon-alfa plus ribavirin, would likely increase the proportion of patients achieving~     undetectable HCV-RNA levels and sustained virologic response (SVR). In this study, SCH 900518~     would be used in combination with low doses of ritonavir to enhance the levels of SCH 900518~     within the body and reduce the number of daily SCH 900518 tablets required. The purpose of~     this study is to identify the optimal dose and schedule (once or twice a day) of SCH 900518~     plus ritonavir in previously untreated patients with genotype 1 chronic hepatitis C when~     given in combination with SOC. The study compares SOC to 6 experimental arms. In the~     experimental arms, SOC plus SCH 900518 doses of 200, 400 and 600 mg once daily or 100 mg~     twice daily with ritonavir 100 mg once or twice daily will be explored. The benefits of a 4~     week lead-in with PegIntron and ribavirin prior to the addition of SCH 900518 will also be~     explored.~   "
211070|NCT00797888|"~     To address and reduce population-attributable risk due to elevated HbA1c, the New York City~     Department of Health and Mental Hygiene (DOHMH) developed an innovative HbA1c registry, which~     requires all major laboratories to report HbA1c results electronically. We propose to utilize~     this registry to conduct a randomized controlled trial addressing the following specific~     aims: 1) to evaluate the incremental effect of a tiered and tailored, patient-centered~     telephone intervention, in English and Spanish, on the mean HbA1c levels beyond that achieved~     with print materials mailed to patients and providers by the DOHMH registry intervention; 2)~     determine what patient demographic and psychosocial factors mediate the effect of the~     interventions; and 3) provide estimates of implementation costs of the tiered, tailored~     telephone intervention for comparison with the print intervention. The study outcome will be~     change in HbA1c values from the registry records from baseline to one-year~     post-randomization. A total of 941 individuals with diabetes will be needed to provide 83%~     power to detect a statistically significant difference (p<0.05) between groups of at least~     0.3% in absolute HbA1c. Intervention cost data will be evaluated for translation of findings~     and scalability. At study end, we will know the extent to which this intervention will~     improve metabolic control in a low-income, multi-ethnic sample who are part of the DOHMH~     HbA1c registry in the South Bronx, New York. These findings will inform public health~     policies and practices in New York City, as well as other urban areas throughout the nation.~   "
211071|NCT00797875|"~     To investigate immediate and short term effects on angle of knee flexion, intensity of pain,~     strength of the knee extensor, and function of the lower extremity by using PNF stretching~     technique in patients with total knee arthroplasty.~      hypothesis:TKA patients may increase ROM after PNF stretching~   "
211072|NCT00797862|"~     This study will compare the safety and efficacy of initial combination treatment with~     aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine~     in patients with hypertension.~   "
211073|NCT00797849|"~     The primary purpose of this study is to determine if the group using Farabloc shows a greater~     reduction in pain levels than the group not using Farabloc at 6-week, 12-week and 1-month~     post treatment follow-ups.~   "
211074|NCT00797836|"~     The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in~     countries with a high proportion of population having received vaccination with the BCG. We~     aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine~     to detect latent tuberculosis in exposed healthcare workers (HCWs)~   "
211075|NCT00797823|"~     This study aims to test an insulin and glucagon delivery algorithm designed to be used in~     conjunction with a continuous glucose monitoring system. This combined glucose~     sensing/hormone delivery approach is a step on the way to eventual development of an~     artificial (or automated) pancreas. The insulin and glucagon delivery algorithm is based on~     the difference between the current blood glucose and the target glucose (proportional error)~     and the rate of change in blood glucose (derivative error), both adjusted for the recent~     glucose history. This algorithm is called the Fading Memory Proportional-Derivative (FMPD)~     Algorithm. The principal investigator of this study has published previous research regarding~     the use of this algorithm and found it to be well-suited to control blood glucose in type 1~     diabetic animals. The addition of glucagon was helpful; better glycemic control with fewer~     glucose excursions were observed when small intermittent infusions of subcutaneous glucagon~     were given during times of impending low blood sugar (Ward et al. 2008).~   "
211076|NCT00797810|"~     All patients are treated according to the same therapy regimen. Therapy duration (number of~     cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy~     consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy~     for Patients in the 18-55 Age Group~        -  Patients in stages III-IV and all patients with mediastinal tumors or extranodal~          involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3).~        -  Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if~          a clear CR has been achieved and there is initially no mediastinal or extranodal~          involvement.~        -  In cases of refractory or progressive disease after 4 cycles, study therapy is stopped.~          These patients are to be given salvage therapy with subsequent stem cell~          transplantation. Therapy for Patients older than 55 years~        -  The course corresponds to that of patients in the younger age group, but the regimen is~          dose reduced (A1*, B1*,A2*, B2*, A3*, B3*). Antibody therapy with anti-CD20 is to be~          administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or~          4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of~          8 resp. 6 cycles antibody therapy.~   "
211077|NCT00797797|"~     To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another~     drug called pregabalin in people with fibromyalgia.~   "
211078|NCT00797784|"~     A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of~     Discoid Lupus Erythematosus~   "
211079|NCT00797771|"~     Approximately 250,000 people worldwide are currently being treated with an insulin pump. This~     number is growing dramatically as these devices become smaller and more user-friendly.~     Insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing~     the number of hypoglycemic events.~      The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro-~     infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by~     the pressure of insulin within it to deliver preset basal profiles and patient programmed~     bolus of insulin through custom infusion sets, into subcutaneous tissue.~      This type of device requires extensive user interaction and education in order to ensure its~     safety. This study was designed to test the independent home-use of the NiliMedix ADI Insulin~     Pump, and to evaluate user's satisfaction.~   "
211080|NCT00797758|"~     Multicentric evaluation of the reduction of unrelated cord blood transplantation (UCBT)~     toxicity by using reduced intensity conditioning (RIC) in patients with acute myeloid~     leukaemia.UCBT related mortality and morbidity were limiting factors for the development of~     this procedure in adults. Non myeloablative conditioning regimen showed promising results and~     prospective evaluation has to be developed to confirm these retrospective data.~   "
211344|NCT00794196|"~     The purpose of this study is to evaluate the impact of pharmaceutical services among patients~     starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of~     the study is that pharmacist intervention can improve compliance to antidepressants and~     patient wellbeing.~   "
211082|NCT00797732|"~     The current standard of care for advanced HNC is concurrent chemoradiation therapy (CRT),~     which has led to increased survival rates, but with significant acute and long-term~     toxicities. Dysphagia, or difficulty with swallowing, is a common and expected side effect~     during and following CRT. Dysphagia occurs in up to 50% of patients and significantly impairs~     the quality of life (QOL) of patients during delivery of and recovery from CRT. Clinical~     trials evaluating promising and innovative adjunctive approaches that could increase the rate~     and magnitude of recovery from dysphagia in HNC patients are needed. Acupuncture is a~     traditional Chinese medical technique that has been found to reduce symptoms and side effects~     associated with primary cancer therapy. This study evaluated the feasibility of conducting a~     randomized sham-controlled trial and collected preliminary data on safety and efficacy of~     acupuncture.~   "
211083|NCT00797719|"~     Malignant pleural mesotheliomas (MPMs) are tumours associated with asbestos exposure~     involving the tissue lining surrounding the lung. Radiation therapy (RT) dramatically reduces~     the risk of tumour recurrence within the irradiated area (>90%). But patients continue to~     succumb to MPMs due to the tumour spreading outside the chest cavity. This may be due to~     tumour cells inadvertently contaminating areas outside the chest cavity during surgery. The~     study will look at whether giving a short intense course of chest radiation just prior to~     surgery will sterilized these tumour cells and thus, avoid or reduce contamination of the~     areas outside the chest cavity. The investigators hypothesize that short neoadjuvant~     (pre-operative) hemithoracic RT, followed by immediate planned extrapleural pneumonectomy~     (EPP) (+/- adjuvant chemotherapy) will reduce the risk of intra-operative seeding and reduce~     the incidence of distant metastatic disease.~   "
211084|NCT00797706|"~     The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL~     intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it~     has an ulcer size reduction effect when administered to individuals suffering from venous leg~     ulcers.~   "
211085|NCT00797693|"~     The purpose of this study is to determine whether oral versus vaginal misoprostol is~     effective in termination of first trimester missed abortion and to compare between two~     different routes.~   "
211086|NCT00797680|"~     In this study, children who survive cardiac arrest will be evaluated whether 24 or 72 hours~     of whole body hypothermia (cooling) during recovery is better to help prevent brain injury~     and improve outcome. The investigators will also test the safety of cooling patients for 24~     and 72 hours. The investigators hypothesize that 72 hours of cooling will be more beneficial~     than 24 hours without compromising safety.~   "
211087|NCT00797667|"~     A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with~     episodic migraine.~   "
211088|NCT00797654|"~     This study will develop a therapy for men who have sex with men who also have a history of~     childhood sexual abuse to reduce behaviors that put them at a high risk of HIV infection.~   "
211089|NCT00797641|"~     The aim of this study is to assess the current management strategies in a pan-European~     real-life setting to uncover the unmet need in this area: non-variceal gastrointestinal~     bleedings.~   "
211090|NCT00797628|"~     This is a randomized control trial to determine the efficacy of a multi-modal intervention in~     improving smoking cessation processes of care and patient outcomes in community-based primary~     care practices. Our Overall Goal is to advance science related to the use and impact of the~     Internet in health services delivery, specifically smoking cessation, by targeting primary~     care clinical microsystems. A clinical microsystem is defined as the smallest functional~     healthcare unit. A clinical microsystem is not simply equivalent to a clinical team of~     doctors and nurses, but also the panel of patients cared for by the providers and the~     processes of care that are used.~   "
211091|NCT00797615|"~     Over the past 30 years obesity has reached epidemic proportions in the United States (Ogden~     et al, 2006). While this epidemic affects all socioeconomic levels, certain racial/ethnic~     groups such as Hispanics, are disproportionately affected by obesity and diabetes. The age of~     onset of excess obesity in Hispanic females, formerly young adulthood, is now younger.~     Childhood obesity poses intermediate and long-term health risks, including: type 2 diabetes,~     hyperlipidemia, elevated blood pressure, and metabolic syndrome. Although biological factors~     may influence a child's risk for becoming overweight, the home environment has been shown to~     be a predisposing and reinforcing contextual factor for unhealthy eating and exercise~     behaviors. Since parents are the primary transmitters of Hispanic cultural practices and~     significantly influence their children's diet and physical activity behaviors from preschool~     through high school, family-based weight-gain prevention interventions are likely to be~     effective.~      The goal of this implementation study is to contribute to the reduction of racial/ethnic~     disparities in obesity and risk of type 2 diabetes by tailoring a recently successful~     childhood obesity prevention program originally developed for African American girls to~     implement and evaluate with preadolescent Hispanic girls.~   "
211092|NCT00797602|"~     The purpose of this study is to collect information from medical records to see what effects~     proton beam radiation has on cancer and analyze possible side effects.~   "
211093|NCT00797589|"~     The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus~     Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis.~   "
211094|NCT00797576|"~     The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with~     transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and~     women with atrial fibrillation presenting for cardioversion.~   "
211095|NCT00797563|"~     The purpose of the study was to evaluate the performance of the meter system in the hands of~     subjects and healthcare professionals (HCPs). It also evaluated the product user guides in~     the hands of untrained subjects.~   "
211096|NCT00797550|"~     The hypothesis is that Aastrom TRC autologous bone marrow tissue grafts can be safely used~     to promote bone healing as part of a single level posterolateral spine fusion surgical~     procedure.~   "
211097|NCT00797537|"~     Prospective study with an echography of the 2 knees and radiography of the 2 knees (front and~     profile) for each patient. If found calcification on ultrasound further examination with~     ultrasound wrists, hips and shoulders.~   "
211715|NCT00789256|"~     The purpose of this study is to determine the response rate of the combination of bortezomib~     and melphalan in patients with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic~     Syndromes (MDS).~   "
211099|NCT00797511|"~     The present study is designed to meet the requirements of the Taiwanese Health Authorities~     for registration of ADACEL POLIO in Taiwan.~      Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples~     will be taken for antibody titration. The expected total duration of follow-up for each~     subject will be 28 days.~   "
211100|NCT00797498|"~     The purpose of this study is to collect information from a questionnaire and medical records~     to see what effects proton radiation has on cancer and collect and analyze morbidity~     outcomes: incidence of Xerostomia (dry mouth) and tumor control.~   "
211101|NCT00797485|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving bevacizumab together with combination chemotherapy may kill more~     tumor cells.~      PURPOSE: This phase III trial is studying how well giving induction therapy with bevacizumab~     together with combination chemotherapy with or without capecitabine followed by bevacizumab~     maintenance therapy in treating patients with metastatic colorectal cancer that cannot be~     removed by surgery.~   "
211102|NCT00797472|"~     120 subjects with Hodgkin's disease will be randomly divided into two groups: Group I~     receiving R-mabHD and Group II receiving a combination of Adriamycin,Bleomycin,Vinblastine~     and Dacarbazine. R-mabHD will be given once a week for eight weeks in a row. The ABVD~     combination will be given once every other week for 12 treatments. The hypothesis is that~     intervention with R-mabHD will lead to a quicker remission of Hodgkin's disease than the~     intervention with a combination of ABVD.~   "
211103|NCT00797459|"~     Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L)~     while correcting wrinkles in the area around your nose.~   "
211104|NCT00797446|"~     The purpose of this study is to collect information from the questionnaire and medical~     records to see what effects proton radiation has on cancer and collect and analyze morbidity~     outcomes: incidence of xerostomia (dry mouth) and tumor control.~   "
211105|NCT00797433|"~     This is a study to determine the testosterone serum levels in male patient with acute~     respiratory failure requiring mechanical ventilation. The objective is to determine if low~     levels exist in this population and if it correlates with length of mechanical ventilation.~      Hypothesis: Serum testosterone levels in mechanically ventilated male patients are~     significantly decreased from normal levels and correlate with disease severity and outcomes.~   "
211106|NCT00797420|"~     The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole~     loading dose in infants and toddlers.~   "
211107|NCT00797407|"~     The purpose of this study is to determine of creatine will prevent or treat the muscle~     toxicity side effect of statin drug therapy, whose symptoms are aching, cramping, and~     weakness. This is tested in patients who have had this side effect from 3 different statin~     drugs.~   "
211108|NCT00797394|"~     The purpose of this study is to determine if the combination of 2007RD01, a natural extract,~     and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms~     associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.~   "
211109|NCT00797381|"~     This is an randomized, double-blind, placebo-controlled study to assess the safety,~     tolerability and efficacy of MK-0518 compared to placebo when combined with other~     antiretroviral drugs, in treatment-experienced HIV-infected patients with hemophilia.~      Subjects enrolled in the study sign the consent form, then are randomly assigned to MK-0518~     400 mg twice daily plus optimized background therapy (OBT) group or placebo plus OBT~     group.Each group concludes at least 50 subjects. For each patient, detection of HIV viral~     load and CD4+ T lymphocyte count is done at screening, and at weeks 4, 8, 12 and 24. The~     safety profile of MK-0518 is monitored according to patients' complaints and the results of~     physical and laboratory examinations.~      The safety and efficacy of MK-0518 400 mg b.i.d. compared to placebo, both in combination~     with OBT, will be assessed by review of the accumulated study data in HIV-infected patients~     with hemophilia.~   "
211110|NCT00797368|"~     A recent study has demonstrated that a physical therapist directed exercise program did not~     result in greater reductions in disability and pain when compared to a home exercise program.~     However, no manual therapy procedures were incorporated into the physical therapy treatment~     program despite recent evidence suggesting that thrust and non-thrust manual therapy~     techniques may be beneficial in reducing disability, pain and improving gait. Therefore, the~     purpose of this study is to compare the effectiveness of a physical therapy management~     approach consisting of manual therapy and exercise to a home program of exercise only. The~     investigators hypothesize that the group receiving manual therapy and exercise will have~     better outcomes.~   "
211111|NCT00797342|"~     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner,~     beginning with low doses not expected to have significant biological effects and proceeding~     to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored~     may be limited by tolerability, and will not exceed levels previously shown to be tolerable~     in animals.~   "
211112|NCT00797329|"~     Aggressive behavior, both in the form of violence toward others (injury-inflicting or~     homicide) or toward oneself (suicide or self-injures) create problems of patient management,~     treatment and paroles.~      Biological causes of violent crime were hypothesized by Eysenck (1978), who believed that~     criminality resulted from a nervous system distinct from that of most people.~      The prefrontal cortex, regulates planning of motor acts and executive functions, which are~     critical for inhibitory ability and control of impulsive outburst were found to be impaired~     in violent subjects (Hoaken et al, 2003; Blair, 2001; Brower and Price, 2001; Filley et al,~     2001; Raine et al, 2000; George et al, 2004; Dolan and Park, 2002; Stevens et al, 2003; Raine~     and Yang, 2006), especially in impulsive offenders murderers (Raine et al, 1997; 1998).~     Violence act influenced by nonplaning outboards definite as impulsive aggression (Linnoila~     and Charney, 1999), which one of the most important factor influenced by dangerous behavior~     in general (for review: Skodol, 1998, Moeller et al, 2001; Pontius, 2000; 2004; Siever,~     2008).~      Cholesterol and fats have many roles and may influence brain function and behavior through~     modification of membranes; myelin; enzyme function; absorption and transport of fat-soluble~     vitamins and toxins; and steroid hormones and through effects on production, reuptake, or~     metabolism of neurotransmitters (Boston et al, 1996).~      Since 80-th a strong association was found between low cholesterol levels and violent~     behavior, an association that was not due to age, race, sex, or diagnosis (Mufti et al, 1998;~     New et al, 1999; Alvarez et al, 2000; Golomb et al, 2000; Hillbrand et al, 2000; Troisi and~     D'Argenio, 2006; Chakrabarat and Sinha, 2006).~      Associations between violent behavior, cognitive functioning and total cholesterol level were~     contradicted with difference in samples and behavioral parameters: homicide, homicide~     attempts, rape, physical or verbal aggression, complete suicide or suicide attempts, only~     partially accounted for each measure of behaviors, suggesting that further investigation is~     warranted. Because of the inconsistencies in the available data, we studied retrospectively a~     group of criminal offenders with alcohol and drug use. Our analysis of lipid constituents in~     serum focused on TC, HDL, LDL, and TG.~      Significance of the study. It is possible that cholesterol profile is a biomarker and~     potential predictor of violent in patients with polydrug use.~      The purpose of this retrospective study is to investigate the correlations between~     cholesterol and cognitive profiles in psychiatric patients with violent behaviour. The~     demographic and criminal records, clinical characteristics, cholesterol profiles, and~     cognitive performance data of these patients will be will be intercorrelated.~   "
211113|NCT00797316|"~     The purpose of the study is to evaluate the blood pressure lowering effect and safety of~     aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy~     when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting~     systolic blood pressure [msSBP] ≥ 160 mm Hg and < 200 mm Hg).~   "
211114|NCT00797303|"~     Eight patients with corneal neovascularization were treated with subconjunctival injection of~     1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent~     corneal neovascularization for at least 6 months unresponsive to other treatments. Patients~     were monitored by ophthalmic exam and anterior segment photography.~   "
211115|NCT00797290|"~     The purpose of this study is to collect outcomes information to see what effects~     photon/proton beam radiation has on nasopharynx cancer.~   "
211116|NCT00797277|"~     The aim of this study was to compare the efficacy and safety of intramuscular 10 mg~     olanzapine versus intramuscular 5 mg haloperidol plus lorazepam 2 mg in the treatment of~     acute agitated schizophrenic patients of Taiwanese populations.~   "
211117|NCT00797264|"~     Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced~     Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine~     administrated separately via a continuous infusion, could induced a better analgesic effect.~      We will perform a randomised double blind study to determine the best infusion mode of~     intravenous ketamine, associated with morphine in PCA syringe or alone in continuous~     infusion.~   "
211118|NCT00797251|"~     The use of intraoperative ultrasound (IOUS) allows us to perform new conservative~     hepatectomies. The investigators previously reported the systematic subsegmentectomy by~     IOUS-guided finger compression for segments 2-3, which is currently applied for patients with~     hepatocellular carcinoma (HCC)on cirrhosis. The investigators herein describe a novel~     technique, which consists in the systematic right posterior sectionectomy by IOUS-guided~     finger compression.~   "
211119|NCT00797238|"~     The studied materials contains surgically specimens of two groups of patiens with non-small~     cell lung cancer who have received two regimens of induction (neoadjuvant) chemotherapy~     before tumor resection. Pathological specimens of pre-chemotherapy and post-chemotherapy~     whatever retrievable will be collected. The protein ad RNA expression of DNA repair genes~     (ERCC1, ERCC2, XRCC1, XRCC3, BRCA1 and RRM1) as well as DNA polymorphisms of these genes will~     be studied, and will be correlate with the treatment response and outcome of the patients.~     The aims of this study include:~        1. To identify the expression status of the above DNA repair genes in Taiwanese NSCLC~          patients.~        2. To correlate the expression, as well as DNA polymorphism of each DNA repair gene in~          treatment response to two differenct chemotherapeutic regimens.~        3. To correlate the expression, as well as DNA polymorphism of each DNA repair gene in the~          outcome of stage III NSCLC patients.~        4. To explore whether platinum based chemotherapy will change the expression status of DNA~          repair gene and if indeed changed, whether this would influence the outcome of the~          patients~   "
211120|NCT00797225|"~     This study is designed to evaluate the safety and beneficial effects of NBI-56418 compared to~     placebo and leuprorelin (an approved endometriosis therapy) over a three month period~     followed by an additional three months of treatment on NBI-56418.~   "
211121|NCT00797212|"~     The purpose of the study was to evaluate the performance of the blood glucose monitoring~     system when used with samples taken from the palm and forearm for alternative site testing~     (AST).~   "
211122|NCT00797199|"~     Hormone Replacement Therapy (HRT) is a double edged sword: it can alleviate the effects of~     menopause for a significant proportion of the female population, however for a smaller~     proportion, it will induce a significant increase in their short-term and lifetime risk to~     develop breast cancer (BC). Fewer women are prescribed HRT compared to a decade ago due to~     concerns pertaining to BC by both physicians and patients. By developing a technology that~     could identify women at risk for the adverse effects of HRT, during the first few months of~     its use, physicians may offer HRT to a wider proportion of the female population during~     menopause. More importantly, as it relates to BC prevention, such a technology will identify~     women at risk and provide a useful decision making tool regarding their care during the~     menopausal years.~   "
211123|NCT00797186|"~     This protocol focuses on the development of a noninvasive method of early coronary artery~     disease detection in diabetes. The overall hypothesis is that risk factors for the metabolic~     syndrome will predict invasive findings on intravascular ultrasound (IVUS) and noninvasive~     findings on cardiac magnetic resonance (CMR) perfusion imaging. Secondary objectives will~     include demonstrating the relative importance of individual risk factors early in disease,~     demonstrating the positive effects of aggressive risk factor modification on disease,~     demonstrating the relative importance of treatment of individual risk factors on disease~     progression or stabilization, and that invasive findings on IVUS will predict noninvasive~     findings with CMR. Such techniques may allow earlier noninvasive detection of disease as well~     as tailor treatment early in the disease process making prevention more cost effective.~      The specific aims of this proposal are as follows:~        1. To assess whether risk factors for coronary artery disease, both known and novel,~          predict quantitative and qualitative plaque characteristics on IVUS and alterations in~          myocardial blood flow on CMR.~        2. To assess whether improvements in risk factors through aggressive treatment improve~          microvascular function as measured by CMR and plaque stabilization and/or regression as~          measured by IVUS.~        3. To assess which risk factors are most predictive early in disease and to demonstrate~          which risk factors, when treated, provide the most benefit.~        4. To assess whether findings on CMR predict findings on IVUS, thus, providing a~          noninvasive method of early disease detection.~   "
211124|NCT00797160|"~     The aim of the study is to compare the intubation conditions among propofol and remifentanil~     versus midazolam and remifentanil in premature neonates with respiratory distress syndrome.~     At the same time, to show the group of drugs that could let the neonates with no residual~     sedation after the use of surfactant (the possibility of the premature neonates to be readily~     extubated after the use of surfactant).~   "
211125|NCT00797134|"~     The main objective of this study is to characterize and correlate diabetic macular edema~     (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and~     retinal visual function.~      The secondary objectives of this study are the analysis and characterization of DME~     progression over time (between two visits), and the comparison of OCT data obtained with~     different devices.~      The results of this study will be used exclusively for scientific purposes.~   "
211126|NCT00797121|"~     This study is to investigate whether preoperative biliary drainage can reduce the~     postoperative morbidity in patients with hilar cholangiocarcinoma.~   "
211127|NCT00797108|"~     The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270~     are safe and effective in patients that are hospitalized with community acquired pneumonia.~   "
211145|NCT00796874|"~     RATIONALE: Sometimes prostate cancer may not need treatment until it progresses. In this~     case, active surveillance may be sufficient. Diagnostic procedures, such as magnetic~     resonance imaging, may be a less invasive method of finding prostate cancer that has~     progressed.~      PURPOSE: This clinical trial is studying how well magnetic resonance imaging works in~     detecting cancer progression in patients with early-stage prostate cancer who are undergoing~     active surveillance.~   "
211146|NCT00796861|"~     The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in~     patients with refractory malignant ascites.~   "
211128|NCT00797095|"~     The Health Behaviors in School-age Children (HBSC) study is a consortium of investigators~     from 40 predominantly European and North American countries who conduct a common survey of~     early adolescent health behaviors every 4 years. The survey gathers information about~     nutrition, dieting practices, physical activity, injuries, violence, relationships with~     family and friends, perceptions of school as a supportive environment, alcohol and tobacco~     use and drug use among adolescents, and about the communities in which students live. The~     U.S. sponsors of the survey are the National Institutes of Health and the Health Resources~     and Services Administration. This is the fourth survey done in the United States.~      The objectives of the international HBSC study are:~        -  To assess the prevalence of early adolescent health behaviors~        -  To identify psychosocial factors associated with adolescent behaviors~        -  To provide an opportunity for analyses of cross-national comparisons~        -  To provide an opportunity for analyses of trends in the U.S. and cross-nationally~      In addition to the above, the survey includes additional questions designed to provide~     information about areas of specific national interest, including the following:~        -  To assess the association of school, family, peers, and other environmental factors on~          health behavior and health status~        -  To assess the prevalence and identify factors associated with obesity, diet and physical~          activity~        -  To assess the prevalence and identify factors associated with bullying and risk~          behaviors.~      This is the fourth U.S. administration of the HBSC survey, previously administered in~     1997-1998, 2001-2002, and 2005-2006.~      About 16,000 students in grades 5 thorough 10 at randomly selected public and private schools~     across the United States complete a 30- 40-minute survey. The questionnaires are anonymous;~     students are instructed not to put their name on the survey. When they finish the survey,~     they place it in an envelope and seal it. The envelopes are then put in a box. Reports do not~     include the names of participating counties, cities, school districts, schools, or students.~      The information collected from U.S. school children is compared with similar information~     collected from school children in 40 other countries. The survey is used to help set national~     priorities for school and youth programs, as well as to monitor the progress of these~     programs.~   "
211129|NCT00797082|"~     The aim of the study is to assess the efficacy of cardiac MRI to detect coronary disease in~     diabetic patients. Cardiac MRI will be compared to myocardial scintigraphy with is the method~     being used in current practice. The investigators believe that cardiac MRI will be as~     efficient if not better that myocardial scintigraphy to detect tight coronary artery stenosis~     with the advantage of providing no radiation to the patient. Moreover, the investigators~     believe that cardiac MR will add additional information regarding possible undetected~     myocardial infarction.~   "
211130|NCT00797069|"~     Compare the glycemic and insulinemic responses of a standard nutritional product with two~     diabetes-specific nutritional products in patients with type 2 diabetes.~   "
211131|NCT00797056|"~     This study is designed to test the use of G-CSF in peripheral vascular disease. The~     investigators hypothesize that mobilization of angiogenic cells into the blood by granulocyte~     colony stimulating factor (G-CSF) may stimulate the formation of new blood vessels and result~     in a sustained improvement in blood flow in patients with severe peripheral arterial disease.~   "
211132|NCT00797043|"~     The purpose of this study is to collect information from the questionnaire and your medical~     records to see what effects the proton radiation has on you and your cancer and collect and~     analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.~   "
211133|NCT00797030|"~     This study evaluates the use of topical cyclosporine 0.05% and sodium carboxymethylcellulose~     0.5% for the treatment of dry eye disease in patients infected with the human~     immunodeficiency virus.~      Twenty HIV-positive-patients were selected from the Department of Infectious Diseases of the~     Federal University of Rio de Janeiro Hospital. Dry eye diagnosis was based on a dry eye~     questionnaire (Ocular Surface Disease Index - OSDI®), Schirmer I Test, break up time and 1%~     rose bengal staining of the ocular surface. The patients were divided into two groups with~     ten patients. Group I received sodium carboxymethylcellulose 0.5% drops and group II received~     sodium carboxymethylcellulose 0,5% drops and topical cyclosporine 0.05% for six months.~   "
211134|NCT00797017|"~     The purpose of this observational study is to investigate the impact of fentanyl matrix on~     improvement of pain and functioning in spinal disorder-related chronic pain.~   "
211135|NCT00797004|"~     The purpose of this research is to improve understanding of the molecular and functional~     properties of the human olfactory system.~      The specific aims are:~        -  to determine the location of AC3 and Golf proteins in the human olfactory epithelium~          from freshly harvested nasal/sinus tissue of surgical patients~        -  to perform objective functional studies on fresh human nasal/sinus tissue using an~          electro-olfactogram (EOG) whic measures the electrical activity of olfactory sensory~          neurons in fresh biopsied tissue in response to odor or pheromone stimulation. An~          organotypic culture system for human tissue has been established to optimize the~          electrical signal acquisition.~        -  to correlate the AC3 and Golf expression profiles with pre-operative testing of human~          olfactory function~        -  to correlate the EOG findings with pre-operative testing of human olfactory function.~        -  to systematically evaluate the role of individual intranasal agents on olfaction to~          further optimize the electrical signal acquisition from olfactory tissue.~   "
211136|NCT00796991|"~     The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab~     when combined with Paclitaxel/Carboplatin or Dacarbazine~   "
211137|NCT00796978|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying the side effects of trastuzumab and to see how well~     it works in treating older women with early-stage breast cancer.~   "
211138|NCT00796965|"~     Single Ascending Dose Study~   "
211139|NCT00796952|"~     Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for~     how it should be managed. This pilot randomized controlled trial evaluated the relative~     benefit of a battery of isometric / isotonic exercises on the maintenance of muscle~     composition and function for swallowing in Head / Neck Cancer patients undergoing~     chemo-radiation therapy.~   "
211140|NCT00796939|"~     This study will determine if green light exposure during sleep is effective in reducing mild~     depression symptoms in young men.~   "
211141|NCT00796926|"~     Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry~     Eyes~   "
211142|NCT00796913|"~     ATD therapy for Graves' disease is one of the commonly used options for therapy of the~     hyperthyroidism. The investigators study how to optimally keep patients in remission.~   "
211143|NCT00796900|"~     Dantrolene is used to prevent hyperthermia in intensive care patients suffering from~     subarachnoidal hemorrhage.~   "
211144|NCT00796887|"~     The purpose of this study is to determine the safety, tolerability, and to explore the~     possible benefit of extended-release niacin (Niaspan®) in attempting to improve the recovery~     of patients after ischemic stroke.~   "
223709|NCT00630422|"~     The purpose of this study is to evaluate and determinate the functional abilities in Rett~     syndrome conforming to the established Pediatric Evaluation of Disability Inventory (PEDI).~   "
211147|NCT00796848|"~     The purpose of doing this study is to see if continuous glucose monitoring can help people~     with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose~     reading. For this study we will be using the Navigator Continuous Glucose Monitor. We think~     that your body may not have enough of a certain hormone that usually helps people know when~     they are going low. If you can keep from going low, we think there will be enough of that~     hormone to help you recognize the symptoms of a low before it happens.~   "
211148|NCT00796835|"~     The purpose of this study is to evaluate the dose proportionality of the 3-, 6-, 9-, 12-, and~     15-mg tablets of ER OROS paliperidone. Additionally, the safety and tolerability of the~     treatments in healthy volunteers will be assessed.~   "
211149|NCT00796822|"~     People infected with HIV have a greater risk of developing cardiovascular disease than people~     not infected with HIV. This may be due to increased inflammation brought on by either the HIV~     infection itself or the use of antiretroviral medications to treat HIV infection. This study~     will evaluate an anti-inflammatory drug, pentoxifylline, to determine whether it improves~     blood vessel function and reduces inflammation in people infected with HIV who are not~     currently receiving antiretroviral medications.~   "
211150|NCT00796809|"~     The goal of the project is to study the risk of coccidioidomycosis (valley fever) in patients~     receiving anti-TNF and other biologic agents for inflammatory arthritis in Tucson, Arizona.~   "
211151|NCT00796796|"~     To determine the maximum tolerated dose of the drug temsirolimus given with radiation therapy~     for patients with non-small cell lung cancer.~   "
211152|NCT00796783|"~     This is an observational study to confirm the presence of recurrent or persistent endogenous~     Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for~     Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.~   "
211153|NCT00796770|"~     The purpose of this study is to determine whether the administration of a dendritic cell~     vaccine is a safe and effective treatment for HIV-1 patients.~   "
211154|NCT00796757|"~     This single arm study will assess progression free survival, tumor response and safety of~     Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with~     metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every~     2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week~     (t.i.w.). The anticipated time on study treatment is until disease progression, and the~     target sample size is 100-500 individuals.~   "
211155|NCT00796744|"~     The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it~     can be tolerated, and how different doses effect the healing of the chronic foot ulcers in~     diabetic subjects.~   "
211156|NCT00796731|"~     The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according~     to the dose limiting toxicities (DLTs) observed when administered as a single agent once~     weekly.~      Secondary objectives are:~        -  to characterize the global safety profile~        -  to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule~        -  to assess preliminary evidence of anti-lymphoma activity.~   "
211157|NCT00796718|"~     This single arm study will assess the efficacy and safety of treatment with Xeloda plus~     standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible~     participants will receive Xeloda 825mg/m^2 orally twice daily plus standard radiotherapy for~     5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated~     time on study treatment is < 3 months, and the target sample size is < 100 individuals.~   "
211158|NCT00796705|"~     Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to~     inflammation and progressive joint damage affecting 2.5 million people in the United States.~     The primary purpose of this study is to determine the effectiveness of switching to an~     alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment~     with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate~     clinical response to etanercept or adalimumab.~   "
211159|NCT00796692|"~     Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard,~     unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and~     may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are~     available on the evaluation of body weight adjusted LWMH and standard UFH for the initial~     treatment of PTE in Chinese population. The aim of this study is to determine whether body~     weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of~     patients with objectively documented PTE.~   "
211160|NCT00796679|"~     The purpose of this study is to test the hypothesis that selective vitamin D receptor~     activation reduces left ventricular hypertrophy and ameliorates inflammation and~     atherosclerosis in stage 3 -5 chronic kidney disease.~   "
211161|NCT00796666|"~     As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies~     are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated~     the controlled safety/efficacy database of the combination is limited.~   "
211162|NCT00796653|"~     The primary objective of this study is to assess the long-term efficacy and safety of once~     daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat®~     inhaler, in patients with COPD.~   "
211163|NCT00796640|"~     The purpose of this study is to compare the bioavailability of 2 extended release~     paliperidone pellet formulations under fasting and fed conditions with a 2 mg paliperidone~     oral solution under fasting conditions. Additional objectives are to compare the~     pharmacodynamic effects (postural changes in blood pressure and heart rate), to evaluate the~     safety and tolerability of each treatment, and to explore the relationship between CYP2D6~     genotype and paliperidone exposure.~   "
211164|NCT00796627|"~     This research is being done to increase knowledge about wound healing and different factors~     that may affect healing in burn patients.~   "
211165|NCT00796614|"~     Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin~     hydrochloride as treatment in children with an elevated detrusor leak point pressure~     associated with a known neurological deficit~   "
211166|NCT00796601|"~     The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at~     3 and 6 months compared to placebo.~   "
231608|NCT00524810|"~     Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin~     + Docetaxel in patients with metastatic breast cancer~   "
211167|NCT00796588|"~     The project has been designed to determine whether a brief period of leg ischemia will reduce~     the I/R injury sustained by the liver during liver surgery and liver transplantation. Adult~     patients (aged above 18) for liver resection (LR group) and for orthotopic liver~     transplantation (OLT group) will be analysed separately. Patients from each category will be~     randomised to two groups - a control and a Remote IPC group. In the remote IPC group Ischemic~     preconditioning will be induced during surgery by applying a pneumatic tourniquet to the~     upper part of the right thigh and then inflating it to twice the measured systolic arterial~     pressure in order to occlude the blood supply of the leg for 10 minutes. The tourniquet will~     then be deflated for 10 minutes to reperfuse the leg. This is repeated thrice to precondition~     the skeletal muscles of the leg.~   "
211168|NCT00796575|"~     The main purposes of this study are to assess the safety and measure the pharmacokinetics and~     pharmacodynamics of CS-8080 in healthy volunteers.~   "
211169|NCT00796562|"~     The purpose of this study is to see if giving high dose chemotherapy and total body~     irradiation before and repeating high dose chemotherapy after a bone marrow transplant could~     reduce the incidence of graft rejection and disease for patients with blood cancers~   "
211170|NCT00796549|"~     The primary objective of this open-label, single arm Phase II trial is to explore the~     efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the~     RECIST criteria in patients with EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected~     according to the following scheme:~        -  Forty (40) 1st line patients~        -  Thirty (30) 2nd line patients Patients entered into the trial will be treated and~          followed until death or lost to follow-up. Additional information will be obtained on~          the safety profile and PK analysis of BIBW 2992.~   "
211171|NCT00796536|"~     Chronic pain is a condition in which pain continues for 1 month or more beyond the usual~     recovery period for an injury or illness or persists for months or years due to a chronic~     condition. A commonly used type of psychotherapy called cognitive behavioral therapy (CBT)~     has been found to be effective in treating people with chronic pain. The purpose of this~     study is to determine whether and how CBT geared specifically for treating chronic pain can~     change the way the brain responds to painful emotional and physical stimuli.~   "
211172|NCT00796523|"~     This is a study looking at the Happiest Baby on the Block technique. The investigators~     hypothesized that infants of mothers given a 30 minute videotape demonstrating the Happiest~     Baby on the Block technique would fuss/cry less and sleep longer than infants of mothers~     given a 30 minute videotape on general newborn care. The investigators also hypothesized that~     mothers given the Happiest Baby on the Block videotape would have lower levels of stress.~   "
211173|NCT00796510|"~     As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and~     does not significantly impact sildenafil pharmacokinetics the combination of most promise for~     pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in~     combination.~   "
211174|NCT00796497|"~     Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the~     5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the~     treatment of resistant Obsessive Comulsive Disorder (OCD) patients on combined SRIs and~     antipsychotics.~   "
211175|NCT00796484|"~     The purpose of this study is to evaluate the safety and tolerability of XL888 in subjects~     with solid tumors. XL888 is a potent and selective inhibitor of HSP90, a key component of a~     molecular chaperone complex that promotes the conformational maturation and stabilization of~     diverse client proteins. Many HSP90 client proteins play critical roles in signaling pathways~     implicated in tumor cell growth, proliferation, and survival.~   "
211176|NCT00796471|"~     The purpose of this study is to evaluate the pharmacokinetics of 2 extended-release (ER)~     formulations of 2 mg-eq paliperidone in comparison to the 2 mg immediate-release (IR)~     paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of~     these ER formulations. Additional objectives are to compare the pharmacodynamic effects~     (postural changes in blood pressure and heart rate), safety, and tolerability are to be~     evaluated in addition to exploring the relationship between CYP2D6 and CYP3A4/5genotype and~     paliperidone exposure.~   "
211177|NCT00796458|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy~     may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known whether giving androgen ablation~     therapy together with docetaxel is more effective than giving androgen ablation therapy alone~     in treating patients with advanced prostate cancer.~      PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see~     how well they work compared with androgen ablation alone in treating patients with advanced~     prostate cancer.~   "
211178|NCT00796445|"~     The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic~     product GSK 2132231A in preventing disease relapse when given to melanoma patients, after~     surgical removal of their tumor.~      This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010.~     The impacted sections are outcome measures and entry criteria.~   "
211179|NCT00796432|"~     The purposes of this study are to estimate the relationship of D2-receptor occupancy to~     plasma concentration and to assess the safety of OROS paliperidone.~   "
211195|NCT00796211|"~     This will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory~     study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis.~     Approximately 20 male or female subjects with chronic plaque type psoriasis, 18 to 70 years~     of age, will be included in this study.~      All subjects with stable psoriatic plaques will receive all of the following treatments each~     in a separate test field, once each day for four weeks under occlusion:~        -  CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)~        -  CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)~        -  0.1% nortriptyline HCl topical cream~        -  0.005% calcipotriol topical cream~        -  Vehicle of CRx-197 topical cream (placebo)~   "
211196|NCT00796198|"~     Hypothesis: Studies suggest that patients with low diastolic velocity and high resistivity~     index in the ophthalmic artery had more progressive visual fields, the investigators~     hypothesize therefore that addition of Cosopt to Latanoprost could improve ocular diastolic~     perfusion pressure (ODPP).~      Objective: To evaluate the effects of Cosopt on ODPP in patients not adequately controlled~     with latanoprost alone.~   "
211180|NCT00796419|"~     Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are similar conditions~     in which the lungs are critically injured by another inflammatory process in the body.~     Together they affect more than 150,000 people per year in the United States, with mortality~     approaching 50% and a financial burden estimated to exceed $5 billion. Fluid overload, weight~     gain, and reduced oncotic pressure (low blood proteins) are associated with prolonged need~     for mechanical ventilation and mortality in patients with ALI/ARDS. Historical studies have~     provided conflicting evidence for benefits with colloid or diuretic therapy in ALI/ARDS, but~     recent clinical trials have demonstrated significant improvements in blood oxygen levels. The~     mechanisms of these benefits are not yet certain, but appear to relate to albumin's (a~     protein medicine) specific ability to influence injury and inflammation in the lungs, thus~     improving the ability for the lung to repair and exchange oxygen.~      The purpose of this project is to determine the effects of therapies that affect blood~     proteins on their ability to change the way the lungs and cardiovascular system (heart and~     blood vessels) function. Special measurements will be taken to understand how these protein~     medicines change the ability of the lung and whole body to recover from widespread injury,~     with additional measures of specific heart and lung function. This clinical trial randomizes~     ALI/ARDS patients with low blood protein levels to receive albumin (a natural blood protein~     that is known to influence inflammation) or hetastarch (a synthetic blood protein) with~     diuretic therapy targeted to improve respiratory function. Therapeutic effects on respiratory~     function and blood oxygen levels, extravascular lung water, oncotic pressure, lung fluid~     removal, and heart function will be characterized. This trial will advance our understanding~     of treatment of ALI/ARDS and the factors that affect fluid balance in the lungs of these~     patients.~      Funding Source - FDA Office of Orphan Products Development (OOPD)~   "
211181|NCT00796393|"~     We put forward that probiotics have an effect on infectious episodes evolution in subjects~     aged 60 years or over. The main objective of this research is to observe the effect of~     consumption of the probiotic on the average number of days with infectious episodes.~   "
211182|NCT00796380|"~     The purpose of this study is to evaluate the efficacy of Xingnaojing for the treatment of~     convulsive diseases; to investigate whether convulsion episodes can be induced or aggravated~     by Xingnaojing and the role inflammation plays in the process.~   "
211183|NCT00796367|"~     The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521~     compared to placebo for the treatment of overweight and obesity in adults who have completed~     study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol~     OB-303 (NCT00553787).~   "
211184|NCT00796354|"~     Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.~   "
211185|NCT00796341|"~     Implantation of the human embryo is the limiting factor in the success of~     invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a~     local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in~     the subsequent cycle.We believe that the injury created causes release of substances which~     help in implantation.~   "
211186|NCT00796328|"~     This study is designed to determine the ED90 for an infusion of phenylephrine to prevent~     spinal induced low blood pressure in parturients presenting for an elective cesarean~     delivery. The up-down methodology (UDM) is commonly used study method to determine the dose~     of a drug that causes the desired effect in over 90% of the subjects to whom it given. For~     example: the investigators want to know what is the best dose of phenylephrine (from a range~     of commonly used doses) to prevent a drop in blood pressure during cesarean delivery ninety~     times out of one hundred when it is given at that dose. The ED90 is the effective dose at~     which 90% of subjects will have a positive response to a phenylephrine infusion, i.e. no~     drop in blood pressure. The investigators hypothesize that the ED90 will be between 40 - 60~     mcg/min.~      The primary outcome measure is the ED90 for phenylephrine infusions that prevents a drop in~     blood pressure in women undergoing cesarean delivery.~   "
211187|NCT00796315|"~     The primary goal of this study is to characterize the pharmacokinetics of doxylamine~     succinate in children ages 2 to < 18 years. Once characterized, these pediatric~     pharmacokinetic data will be pooled with historical adult PK data from other studies to~     assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug~     exposure as that associated with efficacy in adults.~   "
211188|NCT00796302|"~     This study will determine the safety and effectiveness of two medications for treating~     aggression in children with attention deficit hyperactivity disorder (ADHD).~   "
211189|NCT00796289|"~     The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH~     delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with~     anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment~     with clomiphene citrate.~   "
211190|NCT00796276|"~     The purpose of this study is to characterize the pharmacokinetics of paliperidone in plasma~     and urine after intravenous (i.v.) administration of the racemate, administration of the~     immediate-release (IR) racemate oral solution, administration of the ER OROS tablet, and~     administration of the oral solutions of the individual enantiomers R078543 (+) and R078544~     (-); to determine the absolute oral bioavailability of IR and ER OROS paliperidone; to~     document the (+) and (-) paliperidone enantiomer ratio after i.v. and oral administration (IR~     and ER OROS paliperidone); to document the possible interconversion between the (+) and (-)~     enantiomers of paliperidone after oral treatment with the separate enantiomers; to document~     the possible relationship between the subject's CYP2D6 phenotype and the (+) and (-)~     enantiomer disposition of paliperidone (CYP2D6 genotyping was used to corroborate the~     phenotype). In addition, the safety and tolerability of all treatments will be evaluated.~   "
211191|NCT00796263|"~     This is a protocol designed to randomize subjects with acute HIV infection to receive~     standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol~     title: Establish and characterize an acute HIV infection cohort in a Thai high risk~     population.~      To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV~     infection period on immunological and virological outcomes.~   "
211192|NCT00796250|"~     This is a double-blind, double-dummy, prednisolone-controlled, multi-center, randomized,~     parallel-group clinical study to evaluate the therapeutic efficacy of repeated infliximab~     infusions in order to maintain Crohn's disease remission at the end of the study.~   "
211193|NCT00796237|"~     The overall aim of the proposed study is to determine whether whole body vibration is~     beneficial in promoting bone turnover, physical fitness and neuromotor performance in~     patients with subacute stroke.~   "
211194|NCT00796224|"~     The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical~     response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER~     (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.~   "
223710|NCT00630409|"~     The purpose of this study is to test the hypothesis that the combination of gemcitabine and~     doxil will have clinical activity in patients with metastatic renal cell carcinoma.~   "
211197|NCT00796185|"~     The purpose of this study is to compare the steady-state pharmacokinetics of paliperidone~     after oral administration of 15 mg extended-release (ER) OROS paliperidone once daily with~     the steady-state pharmacokinetics of paliperidone after oral administration of 8 mg~     immediate-release (IR) risperidone twice daily; and to explore the dose-proportionality of 9~     mg and 15 mg ER OROS paliperidone. Other objectives are to 1) document the disposition of the~     enantiomers of paliperidone; 2) explore the relationship between genotype (CYP2D6, CYP3A4,~     CYP3A5, UGT1A1, and UGT1A6) and pharmacokinetic parameters; and 3) assess safety and~     tolerability.~   "
211198|NCT00796172|"~     High blood pressure and high cholesterol are both causes of cardiovascular disease (CVD), and~     it is important for people with these conditions to adhere to their medication regimens. This~     study will evaluate the effectiveness of a computerized program that provides individualized~     feedback to participants and their doctors for increasing medication adherence among people~     at risk of developing CVD.~   "
211199|NCT00796159|"~     This is a Post-Marketing Surveillance study evaluating the Efficacy, Tolerability and Safety~     of Olmesartan medoxomil 20 mg in combination with 12.5 MG of hydrochlorothiazide in subjects~     with mild to moderate essential hypertension~   "
211200|NCT00796146|"~     To describe clinical, immunological, and virological characteristics of persons with acute~     HIV infection~        1. To describe demographics and behavioral risk factors for those identified with acute HIV~          infection~        2. To describe neurocognitive function and neuroimaging findings in acute HIV infection as~          well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal~          fluid.~        3. To describe the number and characteristics of sexual contacts~        4. To describe the willingness of acute HIV-infected subjects to allow the tracking of~          their sexual contacts for voluntary HIV counseling and testing (VCT)~        5. To describe immune response, HIV-1 genotypes and sequences in the genital compartment~        6. To describe T cell depletion in the gut mucosa in acute HIV infection and describe the~          changes in gut T cell during follow up~        7. To archive samples for future investigations including determination of viral evolution,~          and cell-mediated and humoral immune responses in peripheral blood and mucosal~          compartments~   "
211201|NCT00796133|"~     This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect~     of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.~   "
211202|NCT00796120|"~     The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to~     standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of~     connective tissue cells) (TRS).~   "
211203|NCT00796107|"~     This study will determine the safety and efficacy of R1507 in combination with letrozole in~     patients with advanced breast cancer. In the first part of the study a cohort of patients~     with advanced breast cancer will receive letrozole 2.5mg po daily in combination with R1507~     16mg/kg every 3 weeks. A second cohort of patients who have either progressed or plateaued on~     letrozole treatment will receive 3-weekly cycles of combination treatment with letrozole and~     R1507. The anticipated time on study treatment is until disease progression or unacceptable~     toxicity, and the target sample size is <100 individuals.~   "
211204|NCT00796094|"~     The purpose of this study is to evaluate the potential importance of tissue elasticity in the~     assessment of soft tissues including muscles, tendons and ligaments and other soft tissue~     structures.~      The evaluation of tissue elasticity (easily stretched or moveable) may assist in assessment~     of various soft tissue structures, such as fatty atrophy of muscles, tendon/ligamentous~     injury and healing and other soft tissue structures.~   "
211205|NCT00796081|"~     The purposes of this study are to characterize the pharmacokinetics of paliperidone after~     single- and multiple-dose administration of paliperidone ER in children and adolescent~     patients (>= 10 to <= 17 years of age) with schizophrenia, schizoaffective disorder, or~     schizophreniform disorder and to evaluate the safety and tolerability of paliperidone ER in~     this patient population.~   "
211206|NCT00796068|"~     This phase II trial studies how well giving treosulfan together with fludarabine phosphate~     and total-body irradiation (TBI) works in treating patients with hematological cancer who are~     undergoing umbilical cord blood transplant (UCBT). Giving chemotherapy, such as treosulfan~     and fludarabine phosphate, and TBI before a donor UCBT helps stop the growth of cancer cells~     and helps stop the patient's immune system from rejecting the donor's stem cells. When the~     stem cells from a related or unrelated donor, that do not exactly match the patient's blood,~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor~     can also make an immune response against the body's normal cells. Giving cyclosporine and~     mycophenolate mofetil after the transplant may stop this from happening.~   "
211207|NCT00796055|"~     To determine the safety, tolerability, and the highest dose of this drug given once every 3~     weeks or once every week, (per 21 day cycle) in adult subjects with relapsed or refractory~     solid tumors.~   "
211208|NCT00796042|"~     People with spinal cord injuries posses many factors that increase their risk of developing~     pressure ulcers. Not surprisingly, approximately 82% of persons with spinal cord injury (SCI)~     will experience a pressure ulcer at sometime during their life. Earlier guidelines for the~     assessment and treatment of pressure ulcers produced by RNAO in 20027 recommended that a~     client who has a pressure ulcer on a seating surface should avoid sitting. Unfortunately,~     this recommendation has fueled the long standing view that people with pressure ulcers should~     stop using their wheelchairs and return to bed. The strength of evidence assigned for this~     recommendation was Level=C reflecting the paucity of research evidence to support this common~     practice. Not only do the benefits of bed rest on healing remain to be demonstrated, there is~     mounting evidence that bed rest can be harmful to a person's overall health and well being.~     Bed rest has been shown to be strongly associated with complications in most body systems~     including respiratory, cardiovascular, musculoskeletal, cerebrovascular, gastrointestinal,~     and genital-urinary. Psychosocial complications and cognitive impacts are also well~     documented. Without evidence to dispel the myth that bed rest is best it will be difficult~     to change practice and avoid many of the secondary complications. This study is a pilot study~     to 1) determine whether pressure ulcers heal faster in individuals with SCI who receive an~     individualized community-based, pressure management and mobility program compared to a~     similar group assigned to usual care (bed rest), 2) determine the strength of the association~     between the intervention (pressure/mobility or bedrest) and wound healing, motor~     performance/independence and quality of life while adjusting for motivation to regain~     independence, degree of caregiver burden, and compliance with the intervention, 3) determine~     whether individuals with SCI who participate in a pressure/mobility management program~     experience fewer secondary complications than those who do not participate, 4) determine the~     cost-effectiveness of providing a time-efficient, pressure management and mobility program~     compared to bed rest.~   "
223711|NCT00630396|"~     The primary aim of this study is to find out which of 4 different doses of minocycline are~     safe and well tolerated so that we will know the optimal dose to test in future patients.~   "
211209|NCT00796029|"~     The purposes of this study are to investigate the metabolic pathways of paliperidone and~     excretion of paliperidone and its metabolites in healthy adult male volunteers, both CYP2D6~     poor and extensive metabolizers, after administration of a single 1-mg oral dose of~     14C-paliperidone, to evaluate the safety and tolerability of paliperidone, and to determine~     the relationship between genotypes (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and exposure~     to paliperidone and its metabolites.~   "
211210|NCT00796003|"~     The purpose of this study is to to determine the recommended dose level of JNJ-30979754~     (decitabine) as well as to assess the safety and effectiveness in patients with~     Myelodysplastic Syndrome (MDS).~   "
211211|NCT00795990|"~     This is a retrospective chart review to look at the timing of using indomethacin and~     ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah~     Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention~     in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater,~     with the birthdate being counted as day of life 1.~   "
211212|NCT00795977|"~     The purpose of this study is to confirm safety and immunological responses of Preoperative~     intratumor dendritic cells injection immunotherapy using immature dendritic cells with S~     pyogenes Preparation (OK-432) for patients with resectable pancreatic cancer for pancreatic~     cancer patients.~   "
211213|NCT00795964|"~     Lung function impairment is common after abdominal surgery. Few preventive strategies exist~     against postoperative lung function impairment. A new potential preventive strategy against~     postoperative lung function impairment comes from research on critically ill patients with~     severe respiratory failure. In this field research has long focused on influence of breathing~     volume (= tidal volume) during mechanical ventilation on outcome. It has been shown, that low~     tidal volumes improve patients outcomes as compared to (conventional) high tidal volumes.~     Therefore, we propose a patient and investigator blinded randomised trial to test the~     hypotheses that intraoperative mechanical ventilation with low tidal volumes as compared to~     high tidal volumes reduces postoperative lung function impairment in high risk patients.~   "
211214|NCT00795951|"~     An open, prospective,single-site, non-randomized study of the efficacy and safety of T.R.U.E.~     TEST Panel 1.1, 2.1 and 3.1 allergens in children and adolescents~   "
211215|NCT00795938|"~     This study to will compare the blood levels of sildenafil following administration of an~     experimental tablet vs. the conventional oral tablet.~   "
211216|NCT00795925|"~     The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics~     as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years~     of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of~     detrusor overactivity (overactive bladder) for determination of the recommended dose in~     children.~   "
211217|NCT00795912|"~     Inflammation and fibrosis may be important contributors to worsening heart failure. As well~     as lowering cholesterol, statins are also known to reduce inflammatory markers such as~     C-reactive protein which are elevated in severe heart failure. Therefore, this project will~     evaluate the benefit, if any, of statins on markers of heart structure and function, on~     inflammatory markers and markers of fibrosis in patients with normal cholesterol.~   "
211218|NCT00795899|"~     The present clinical trial will investigate the safety and efficacy of a sequential~     preoperative therapy with Epirubicin/Cyclophosphamide in combination with~     Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2~     overexpression primary breast cancer.~   "
211219|NCT00795886|"~     Objectives:~      Primary objective: Evaluate toxicity of rapamycin when used for post-bone marrow transplant~     graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL).~      Investigator initiated; four participating institutions; Phase II pilot study~   "
211220|NCT00795873|"~     Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over~     5 years.~   "
211221|NCT00795860|"~     Clearly the effects of diet and exercise are beneficial for obese persons, but the underlying~     mechanisms for the improvements in metabolic health are not completely clear. Although~     mounting evidence suggests that alterations in lipid metabolism in persons with abdominal~     obesity are associated with a several medical complications, including diabetes, little is~     known about the factors responsible for this effect. The project in this application is~     designed to examine how the addition of endurance exercise training to a weight-loss program~     alters whole-body fatty acid availability, uptake, and oxidation as well as the expression of~     cellular factors that regulate these processes. In addition, we will evaluate whether these~     alterations are associated with improvements in insulin sensitivity. In the end, these~     experiments will provide insight into the cellular and whole-body adaptations in fatty acid~     metabolism in response to weight-loss and exercise training that may lead to enhancement of~     insulin sensitivity. Identifying relationships between gene expression, whole-body fatty acid~     metabolism and clinical outcome measurements, such as insulin sensitivity, may lead to~     improvements in the therapeutic and/or the preventative approach to obesity and its~     co-morbidities.~   "
211222|NCT00795847|"~     It is difficult to control morning hypertension in practical clinical situation. Angiotensin~     receptor blocker (ARB) and thiazide are suggested to be effective to maintain the~     antihypertensive effects for 24 hours. However, monotherapy sometimes is not enough to~     control blood pressure level in the next morning and there are little evidence of the~     combination therapy for morning hypertension. The investigators hypothesized that a losartan~     50 mg/hydrochlorothiazide 12.5 mg combination drug, Preminent, is effective and safe for~     controling morning hypertension, compared with high-dose of losartan 100 mg, in Japanese.~     Patients with morning hypertension were randomized to preminent treatment group or high-dose~     losartan treatment group. The efficacy and safety were compared after 3-month treatment.~   "
211223|NCT00795834|"~     The purpose of this study is to assess the effects of a novel beverage rich in polyphenols~     (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.~   "
211224|NCT00795821|"~     The purpose of this study is to assess whether LY2216684 is superior to placebo in the~     treatment of adult patients with major depressive disorder.~   "
211363|NCT00793936|"~     There are specific guidelines for choice of Lt DLT size in correlation to patient's height~     and tracheal diameter on chest X-ray/CT scan. Accordingly to these criteria the RT DLT size~     is determined.~      Should the criteria for determining the appropriate size be the same for Rt and Lt DLT?~   "
211225|NCT00795808|"~     1. Metformin increases the pregnancy rate when added to the standard treatment of~          anovulatory polycystic ovary syndrome (PCOS).~        2. Metformin in combination with clomiphene, is more effective than clomiphene alone or~          metformin alone improves fertility outcomes in women with PCOS of reasonably healthy~          body weight (BMI </= 32).~        3. Metformin improves fertility outcomes in women with BMI > 32 with PCOS.~   "
211226|NCT00795795|"~     An increased incidence of aneuploid pregnancies has been reported in women of advanced~     maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos~     have shown elevated aneuploidy rate, particularly in women over 38 years. For these reasons,~     PGS has been applied to these patients to improve ongoing implantation rates, and most~     importantly, to decrease the risk of further miscarriages and affected offspring. In the past~     two years, several RCT have raised the question whether PGS is benefitial or not in AMA~     patients.~      In our experience, PGS outcome in these patients offers higher ongoing implantation rates~     than the previously published in RCT studies, where no benefits for PGS were found. In these~     papers, poor technical skills, as well as unclear patients selection could explain the~     reported lack of PGS benefits.~      Therefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and~     without PGS in two age groups:~        -  Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be~          performed~        -  Patients 40-44 years of age: 120 cycles per arm reaching embryo transfer Sample size has~          been calculated according to our retrospective experience with higher differences in~          ongoing implantation rates between cycles with and without PGS in patients of 40-44~          years of age. In all patients embryo transfer will be performed on day 5. In the PGS~          group one cell will be biopsy in embryos with ≥5 cells on day-3 and chromosomes 13, 15,~          17, 18, 21, 22, X and Y will be analyzed in two rounds. In the third round, nuclei with~          undoubtful or non-conclusive results will be analyzed using subtelomeric probes.~   "
211227|NCT00795782|"~     The purpose of this study is to determine whether the prophylactic ipsilateral central lymph~     node dissection is equally effective in the management of papillary thyroid~     microcarcinoma(PTMC) to the bilateral central lymph node dissection.~   "
211228|NCT00795769|"~     RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing~     stem cell transplant.~      PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and~     vomiting in patients undergoing stem cell transplant.~   "
211229|NCT00795756|"~     The aim of this clinical study in adult ALL is to compare by risk category (1) the~     feasibility of two different CNS prophylaxis regimens and (2) the overall disease-free~     survival in relation to the achievement of an early MRD negative status and following~     consolidation with lineage-targeted methotrexate infusions and other disease-specific~     therapeutic elements, with or without the application of allogeneic or autologous SCT~     depending on risk class and MRD study results.~      In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all~     patients receive induction/consolidation therapy incorporating lineage-targeted high-dose~     methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the~     achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final~     consolidation phase.~   "
211230|NCT00795743|"~     Hypothesis to be tested: placement of a central venous catheter will induce a systemic~     hypercoagulable state. To determine this, the investigators will measure thromboelastography~     (TEG), PT(prothrombin time), PTT (partial thromboplastin time), Prothrombin Fragment 1.2,~     Factor VIII, and VonWillebrand's Factor. In addition, duplex ultrasound will be performed to~     correlate the laboratory coagulation values with functional changes (i.e. deep venous~     thrombosis).~   "
211231|NCT00795730|"~     This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and~     tolerability in healthy subjects and subjects with Alzheimer's Disease~   "
211232|NCT00795717|"~     The purpose of this study is to determine whether fish oil supplementation with Lovaza,~     formally known as Omacor will result in a significant reduction in serum triglyceride (TG),~     an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.~   "
211233|NCT00795704|"~     The purpose of this study is to evaluate whether mulberry leaf extract will help control~     blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry~     leaf extract in these patients.~   "
211234|NCT00795691|"~     The purpose of this study is to determine the effects of a low-carbohydrate diet compared to~     a low-fat/high-carbohydrate diet on glucose control in patients who have Type 2 Diabetes.~   "
211235|NCT00795678|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Studying samples of tumor tissue and blood from~     patients may help doctors understand how well these drugs can be carried to the brain.~      PURPOSE: More definitive knowledge of the penetration of chemotherapeutic and other agents~     into the brain is necessary for the future rational design of drug and drug regimens that~     target brain metastases. This clinical trial is studying how well capecitabine,~     cyclophosphamide, doxorubicin, gemcitabine, lapatinib, paclitaxel, trastuzumab, or~     vinorelbine penetrates brain tumors.~   "
211236|NCT00795665|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such~     as carmustine, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving bevacizumab together with carmustine may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with carmustine~     works in treating patients with relapsed or progressive high-grade glioma.~   "
211346|NCT00794170|"~     Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma~     treatment compliance (e.g., medication-taking and refill compliance, return for clinical~     follow-up) and more positive eye health outcomes at 12-month follow-up than participants who~     receive the control group intervention.~   "
211237|NCT00795652|"~     The purpose of the MOM: Managing Our Mood Program (part of Family Help) is to evaluate the~     effectiveness of the Family Help distance intervention compared to usual or standard care~     typically provided to women with mild to moderate postpartum depression symptomology. This is~     a single-center trial based at the IWK Health Center. The primary outcome is change in~     postpartum depression diagnosis.~   "
211238|NCT00795639|"~     This protocol is for subjects with pulmonary arterial hypertension and is the first of 3~     studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective~     Assessment of Adding Sildenafil (SR-PAAS) program.~   "
211239|NCT00795626|"~     Evaluate the impact of systematic nursing orientations in the reduction of predicted~     cardiovascular risk in patients with coronary artery disease during four nursing visits for a~     1-year period and compare to a group of patients submitted to conventional treatment.~   "
211240|NCT00795613|"~     The purpose of this multicenter clinical trial is to assess the clinical impact of dose~     intensification performed very early during treatment in a subset of poor prognosis,~     advanced-stage Hodgkin Lymphoma patients, defined as PET-positive after two courses of~     conventional adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD)~     chemotherapy.~   "
211241|NCT00795600|"~     This trial is conducted in Europe. The aim of this clinical trial is to compare the change in~     trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of~     treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined~     with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.~   "
211242|NCT00795587|"~     Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients~     suffering intracranial hypertension following traumatic brain injury?~   "
211243|NCT00795574|"~     A study to assess the safety and efficacy of the IV drug infliximab for the treatment of~     hidradenitis suppurativa~   "
211244|NCT00795561|"~     Upto 80% of all pregnant women experience some form of nausea and vomiting (NVP) during their~     pregnancy. Hyperemesis gravidarum, a more severe form of NVP affects approximately 0.3- 2.0%~     of pregnancies and is the commonest indication for admission to hospital in the first half of~     pregnancy and second only to preterm labor as a cause of hospitalization overall. According~     to the Hyperemesis Education and Research Foundation, conservative estimates indicate that HG~     can cost a minimum of $200 million annually in house hospitalizations in the United States of~     America. The investigators aim to conduct a randomized controlled trial to test the~     hypothesis that the availability of day care services for the initial treatment of NVP~     reduces the mean duration of stay in hospital by 1 day and results in significantly greater~     patient satisfaction compared with standard inpatient management.~   "
211245|NCT00795548|"~     This open label phase-II trial evaluates hematological response of an additional treatment~     with 5-Azacitidine to common DLI in patients with MDS or AML relapsing after allogeneic stem~     cell transplantation.~   "
211246|NCT00795535|"~     The purpose of this study is to develop new triage tool for trauma patients based on HRV. EKG~     will be prospectively measured in trauma patients in two locations: in the prehospital~     setting (the field and during transport by helicopter) and in the hospital setting. In each~     case HRV will be derived from the EKG signal, will be correlated with other non-invasive~     signals (e.g. near infrared spectroscopy (NIR), and bispectral EEG (BIS)), along with other~     routinely measured variables (blood pressure, respiratory rate, pulse oximetry, etc), will be~     correlated with injury severity and day of discharge. An algorithm will be constructed using~     multiple linear regression. The hypotheses are:~        1. reduced HRV in the field correlates with bad outcome;~        2. the specificity and efficiency of HRV as a screening tool can be improved by controlling~          factors such as heart rate, age, gender, respiratory rate, and pulse oxygen saturation;~        3. an easy to interpret HRV index can be derived that can be used for trauma triage or~          diagnosis.~   "
211247|NCT00795522|"~     This open-label study is being conducted to determine the effect of DL treatment for CIU on~     symptom and disease severity, quality of life, daytime functioning, and quality of sleep.~   "
211248|NCT00795509|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
211249|NCT00795496|"~     The investigators will contact 64 patients with atopic dermatitis (AD) who participated in a~     long-term tacrolimus ointment trial in Helsinki 10 years ago, and ask them to participate in~     this follow-up study. The investigators will do the same tests as 10 years ago, i.e.~     bronchial hyperreactivity, skin prick tests, serum-IgE, Mantoux-test (2 TU), and~     questionnaires about asthma and allergic rhinitis symptoms. The investigators also collect~     data about their AD medication during the last 10 years.~      The investigators hypothesis is that when the skin condition improves in patients with AD the~     brochial hyperreactivity improves. The investigators also want to study whether different~     treatments play a role in the development or resolution of bronchial hyperreactivity.~   "
211250|NCT00795483|"~     The purpose of this project is to determine the incidence of osteoporosis in the~     investigators' population of HIV-infected patients and to assess the efficacy and security of~     zoledronic acid, whose efficacy in post-menopausal women with high fracture risk treatment~     and in Paget's disease treatment has already been demonstrated.~   "
211270|NCT00795210|"~     The purpose of this study is to examine the short-term effects of two different doses of~     growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's~     secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth~     hormone administration will alter the body's endogenous pulsatile growth hormone secretion~     and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that~     growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to~     insulin sensitivity.~   "
211271|NCT00795197|"~     A screening study to identify and characterize the disease status of patients with Gaucher~     Type 1 disease for potential inclusion in a subsequent phase 3 clinical study.~   "
211347|NCT00794157|"~     This study was designed to provide pivotal confirmation of efficacy and safety data for 2~     doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe~     chronic obstructive pulmonary disease (COPD). Data from this study will be used for the~     registration of indacaterol in Japan.~   "
211251|NCT00795470|"~     Urinary tract infection (UTI) is a common infection in patients in the intensive care unit~     (ICU) that increases length of stay but not mortality. It is not known whether antibiotic~     treatment will alter outcomes. Our previous studies have documented wide practice variations~     exist amongst doctors, including prescribing antibiotics to asymptomatic patients. Therefore,~     the merits of various ways to manage the infection require further studies to minimize the~     potential for over-prescribing of antibiotics, a practice that can increase the development~     of resistant bacteria.~      The objective of this pilot study is to determine the feasibility of conducting a larger~     definitive study that will determine the effect of catheter change and/or systemic~     antibiotics as compared to no interventions on outcomes and resource utilization in ICU~     patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone,~     urine catheter change alone, and both catheter change and antibiotics. Their clinical~     outcomes will be assessed.~      Results from the pilot trial will provide information about whether it is feasible to conduct~     the larger definitive trial. Results of the definitive study will provide guidance to~     clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.~   "
211252|NCT00795457|"~     This is a pilot vaccine study in adults with either WHO grade II astrocytoma,~     oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and~     efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in~     combination with the study drug Poly-ICLC.~      Poly-ICLC, manufactured by Oncovir, Inc., has already been received and generally well~     tolerated by subjects in earlier studies and has been shown to decrease the size of brain~     tumors in some cases.~      The immunological and safety data will be used to decide whether a larger study of clinical~     efficacy is warranted in each of two patient cohorts.~   "
211253|NCT00795444|"~     The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with~     a viral load below 50 copies/mL is the main limitation to eradication of the virus from the~     body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore,~     patients are obliged to continue with treatment for a period calculated to be greater than 60~     years.~      Despite the important advances in knowledge of the biology of this reservoir, we still have~     no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the~     first time with CCR5 coreceptor antagonists is exceptional, since the results could provide~     important information on the nature of this reservoir.~      If maintenance of the reservoir is a dynamic process, inclusion of CCR5 inhibitors is~     expected to lead to a reduction in the size of this reservoir. This effect could be critical~     when including IAT (viral reactivation), since, in theory, it would be necessary to act on a~     smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of~     the viral reservoir (approximately 1,000,000 cells).~      The study has also been designed to enable us to understand the biochemical and molecular~     mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step~     to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.~   "
211254|NCT00795418|"~     This study will evaluate the safety and tolerability of repeated subcutaneous injections of~     CAD106 in patients with mid Alzheimer's disease~   "
211255|NCT00795405|"~     Major sporting events may have adverse cardiovascular effects in subjects with coronary heart~     disease. We also hypothesized that the adverse cardiovascular effects of sporting events are~     a result of psychobiological processes including stress-induced hemodynamic changes,~     autonomic dysfunction and parasympathetic withdrawal, and inflammatory and prothrombotic~     responses, all of which may in turn promote myocardial ischemia.~   "
211256|NCT00795392|"~     Perioperative psychological care is increasingly recognized as an essential part in the~     surgical environment. Previous studies have developed a strategy to evaluate the~     psychological influence after operations and found that postoperative psychological states~     significantly associated with the outcomes of patients. However, preoperative evaluation of~     patients the physicians do thus far is mainly the physical status assessment following the~     scale of American Society of Anesthesiologists (ASA). Whether a full-scale evaluation of~     preoperative psychological status to surgical patients could be a predictor to postoperative~     outcomes or not is not still completely understood. The investigators hypothesized that the~     preoperative psychological assessment would be an important predictor to outcomes.~   "
211257|NCT00795379|"~     To assess the effectiveness of Interoceptive Exposure (IE) as a treatment to reduce negative~     cognitions and arousal in a veteran sample during an anxiety-inducing situation (i.e., the~     Trier Social Stressor Task - an analogue to the anxiety of undergoing exposure-based~     treatment). After completing the initial screening, qualifying participants will complete a~     pre-intervention assessment at UMC (structured clinical interview, self-report measures, and~     a treatment-engagement analogue exercise). Half of the participants will be randomized into~     either supportive counseling or to the treatment protocol at GVSMVAMC consisting of four~     sessions of Interoceptive Exposure over a four week period targeting interoceptive stimuli.~     Veterans will be assessed a second time at UMC after treatment (5 to 6 weeks after the first~     assessment). Participants will include approximately 40 male OEF/OIF veterans with~     combat-related PTSD recruited from the Trauma Recovery Program (TRP) and Post-deployment~     Clinic at the G.V. (Sonny) Montgomery VAMC (GVSMVAMC). Following the pre-intervention~     assessment, veterans will be randomized into one of two groups. Half of the veterans (n = 20)~     will receive received four weeks of supportive counseling while the other half will receive~     four weeks of Interoceptive Exposure (IE). The proposed study examines anxiety sensitivity~     (AS) as a possible barrier to treatment engagement in exposure therapy for PTSD. AS is a~     dispositional cognitive characteristic defined as the fear of sensations directly related to~     autonomic arousal that arises from the belief that these sensations have harmful~     consequences. Interoceptive Exposure (IE) is an intervention that: 1) helps individuals with~     high AS increase their tolerance to the somatic sensations of arousal; and 2) promotes an~     adaptive appraisal of fear-related sensations The current study will use a social stressor~     task to assess the affect of IE on AS and avoidance among veterans who have PTSD, thereby~     increasing the likelihood that a veteran will enter into, and remain in, treatment for PTSD.~   "
211272|NCT00795184|"~     This study will collect data from patients routinely undergoing a endoscopic surveillance and~     Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to~     determine if endomicroscopy images collected using the marketed Cellvizio device may help~     endoscopists more accurately diagnose, in conjunction with traditional tissue sampling~     techniques, whether a suspected lesion is malignant or benign.~   "
211273|NCT00795171|"~     Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes~     induced by docetaxel in HRPC patients~   "
211345|NCT00794183|"~     The idea of this study is to compare different ways of setting up a pacemaker, using blood~     tests to give us information about how well it's working. We hope to learn if we can use this~     approach to figure out the best pacemaker setup (programming) for each individual patient.~      The setting we propose to adjust is the timing between the impulse sent between top and~     bottom chambers.~   "
211258|NCT00795366|"~     Traumatic brain injury (TBI) is among the leading causes of trauma death and disability in~     both civilian and military populations. The damage that occurs at the instant of trauma~     cannot be modified; the secondary injuries that occur afterward are the impediments to~     recovery and can be influenced by the physician. Cerebral ischemia is the most important~     secondary event that determines outcome following TBI. To minimize ischemic episodes once the~     patient has arrived at the hospital, most treatments are aimed at optimizing cerebral~     perfusion pressure (CPP). The cornerstones of these treatments include mannitol, to reduce~     intracranial pressure (ICP), and catecholamines, such as phenylephrine (PE), to increase mean~     arterial pressure (MAP), but these agents have undesired side effects. Nevertheless, once~     they lose potency, there are few alternatives. The main objective of this proposal to develop~     a new therapeutic option for CPP management in TBI patients using arginine vasopressin (AVP).~      AVP is the endogenous anti-diuretic hormone. It is FDA-approved for use in the diagnosis and~     treatment of diabetes insipidus, for the prevention and treatment of post-operative abdominal~     distention, and in abdominal radiography to dispel interfering gas shadows. It has been used~     off-label for several other conditions. There is minimal information on its therapeutic~     potential after TBI. The investigators have demonstrated that AVP during fluid resuscitation~     rapidly restored hemodynamics, CPP, and improves acute survival in a clinically-relevant~     model of TBI. The investigators observed similar short term benefits after chest and liver~     trauma. Nevertheless, AVP has actions that could mask any short term benefit. The~     investigators have already defined risks and benefits of AVP therapy, relative to PE, in four~     different clinically-relevant laboratory model. The investigators now plan to evaluate this~     new therapy relative to the current evidence-based guideline for CPP management in TBI~     patients.~      The working hypothesis is that the risk/benefit profile for AVP is equal, or superior to, PE~     at equi-effective doses for the management of CPP following TBI. A corollary is that a higher~     CPP can be safely tolerated with AVP vs catecholamines.~      THE INVESTIGATORS AIM TO: Determine whether AVP is safe and effective to maintain CPP = 60 mm~     Hg in TBI patients.~   "
211259|NCT00795353|"~     The study is a prospective, multi-centre, observational study designed to assess the~     long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic~     plaque psoriasis.~   "
211260|NCT00795340|"~     RATIONALE: Cediranib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. It is not yet known whether cediranib is more effective than a~     placebo when given together with paclitaxel and carboplatin in treating patients with~     non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying how well cediranib works when given~     together with paclitaxel and carboplatin in treating patients with stage IIIB or stage IV~     non-small cell lung cancer.~   "
211261|NCT00795327|"~     Primary:~      Evaluate the degree of correction attainable with Poly-L-Lactic Acid(Sculptra) for the~     correction of hill and valley acne scarring~      Secondary:~      Document types and incidence of device adverse events with Poly-L-Lactic Acid(Sculptra)~     therapy.~   "
211262|NCT00795314|"~     Uterine curettage is usually performed under the anesthesia of propofol-fentanyl or~     para-cervical block,of which generally has significant incidence of respiratory depression~     which increases the demand on intraoperative monitoring, or has unavoidable insufficient~     blockade which results in intraoperative suffering of pain. Butorphanol is an analgesic with~     combined effects on mu and kappa opioid receptors leading to a role as analgesia and~     sedation. The investigators hypothesized that combined propofol with butorphanol during~     uterine curettage would produce optimal effectiveness of these two drugs by adding sedative~     and analgesic effects together. In addition, it would decrease the intraoperative consumption~     of propofol without increase the incidence of side effects. Furthermore, such combination~     would alleviate postoperative pain.~   "
211263|NCT00795301|"~     Primary Objectives To estimate the pathological complete response rate following neoadjuvant~     radiotherapy with concurrent capecitabine and oxaliplatin, with or without cetuximab based on~     the KRAS mutation status in rectal cancer.~      Secondary Objectives~        1. To evaluate the incidence of grade 3-4 toxicities with each of the two neoadjuvant~          regimens and during the 30-day post-operative period.~        2. To estimate the clinical tumour response rate and sphincter preservation rate with each~          of the two neoadjuvant regimens.~        3. To correlate EGRF gene amplification with pathological response rate in those treated~          with cetuximab.~        4. To estimate the pattern of failure.~        5. To establish an annotated tissue library with samples being obtained prior to therapy~          and following therapy (at the time of surgery).~   "
211264|NCT00795288|"~     The primary objective of this project is to investigate the effect of statin therapy on~     cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not~     receive statins in a blinded design.~   "
211265|NCT00795275|"~     Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of~     glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to~     abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the~     objective of the current study. The investigators hypothesized that defects in GLP-1 may~     explain the inappropriate basal EGP and diminished insulin secretion in IFG, and,~     furthermore, that by increasing circulating GLP-1 levels (using a new medicine called~     sitagliptin) the investigators could reverse these defects.~   "
211266|NCT00795262|"~     We will evaluate the combination of quinapril and alpha lipoic acid in patients with diabetes~     mellitus and hypertension. We will determine whether the combination of quinapril and lipoic~     acid as compared to quinapril and placebo provides benefit on systemic blood pressure and~     proteinuria.~   "
211267|NCT00795249|"~     The investigators hypothesized that circulating EMP is a useful surrogate marker of early~     stage of endothelial damage. To determine the effects of chronic smoking on circulating EMP,~     from healthy volunteers who have habit of chronic smoking, peripheral blood is drawn at the~     time of flow-mediated dilatation (FMD) examination. Spot urine is also collected. Circulating~     EMPs are counted using flow-cytometry. After 2-week smoking cessation, the measurements were~     repeated.~   "
211268|NCT00795236|"~     The purpose of this study is to learn more about abnormal body rhythms in blind boys and~     girls that keep them from falling asleep at bed-time or cause them difficulty staying alert~     during the day. The investigators hope to learn if there are any differences between the body~     rhythms of girls and boys. The investigators also want to investigate whether age or puberty~     have an effect on body rhythms.~   "
211269|NCT00795223|"~     Comparative efficacy of 24 and 48 hours post operative pain control in single total knee~     replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or~     0.5 % bupivacaine for single femoral nerve block~   "
216804|NCT00721539|"~     To assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc.,~     Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the~     oral cavity and laryngopharynx.~   "
211274|NCT00795158|"~     The purpose of this study was to determine the effect of desloratadine treatment on quality~     of life, daytime functioning, quality of sleep, symptoms, and disease severity in patients~     who had hives for 6 weeks or longer. Patients took desloratadine for 1 month. Once a week,~     patients filled out a questionnaire to tell how their hives affected their lives. This~     questionnaire is called the Dermatology Life Quality Index or DLQI. They also filled out a~     diary every day to tell how much itching they had, how many hives they had, and how their~     hives had affected their sleep or daily activities. The patients and doctors rated the~     patients' overall condition and how much relief patients got from treatment.~   "
211275|NCT00795145|"~     The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG~     readings) which could predispose patients to ventricular arrhythmias. This study is conducted~     to satisfy this requirement.~   "
211276|NCT00795132|"~     This is a phase II trial of reduced intensity conditioning with Bu/Flu/ATG in pediatric~     patients with hematologic malignancies at high risk for transplant related mortality with~     standard transplantation. Patients qualify based on organ system dysfunction, active but~     stable infection, history of previous transplant or late stage disease. We plan to enroll 45~     patients through the Pediatric Blood and Marrow Transplant Consortium (PBMTC) and anticipate~     that the outcome of the trial will pave the way for phase II or III disease specific~     protocols addressing efficacy of the approach compared to standard transplant approaches in~     better risk patients.~   "
211277|NCT00795119|"~     To diagnose bleeding inside the head, children need to have a CT Scan or MRI of their heads.~     Not all doctors order these though, especially when there is no history of injury or when~     children don't look too sick. Unfortunately, this means that some children's bleeding doesn't~     get diagnosed as early as it could. This study wants to find a way to detect bleeding inside~     the head without using a CT scan or MRI.~   "
211278|NCT00795106|"~     Chronic neck pain is a common condition that can negatively impact quality of life. Substance~     P is one of the chemicals in the body that can transmit pain signals from overloaded neck~     muscles to the brain. Topical capsaicin blocks the action of Substance P by releasing, and~     subsequently depleting the body's store of Substance P in the nerves. Topical capsaicin has~     been reported to be an effective therapy for a number of persistent pain conditions including~     diabetic neuropathy, post-herpetic neuralgia, osteoarthritis, rheumatoid arthritis, and~     post-mastectomy pain. This study will evaluate the efficacy of topical capsaicin to reduce~     pain and improve health-related quality of life in adults with chronic muscular neck pain.~   "
211279|NCT00795093|"~     The purpose of this study is to describe common treatment pathways, to collect health care~     utilization data and to assess symptom load as well as impact of symptoms on daily life in~     GERD patients who are partial-responders to PPI treatment.~   "
211280|NCT00795080|"~     The purpose of this study is to decide which position of the neck affects cerebral spinal~     fluid (CSF) flow between the spinal cord and the brain. CSF is a fluid that flows up and down~     your spinal cord, around the brain and into the ventricles of the brain.~      This study will be done with patients who have abnormalities of the neck, including Chiari 1~     malformations.~   "
211281|NCT00795067|"~     The investigators hypothesized that circulating endothelium-derived microparticle (EMP) may~     be a useful surrogate marker of atherosclerosis and future episode of cerebrovascular events.~     Peripheral blood is drawn at the time of carotid ultrasound examination. Circulating EMPs are~     counted using flow-cytometry. The correlation among circulating EMP, ultrasound findings, and~     atherosclerotic risk factors are determined by multiple stepwise regression analysis. The~     prevalence of cerebrovascular events is also determined during 3-year follow-up period.~   "
211282|NCT00795054|"~     The purpose of this pilot study is to determine the feasibility of conducting a study of~     out-of-pocket costs and the long-term financial impact of allogeneic stem cell transplant.~   "
211283|NCT00795041|"~     The purpose of this study is to explore the concept of temporally splitting ovarian~     stimulation and embryo transfer.~   "
211284|NCT00795028|"~     Patients who have suffered a first hip fracture have a higher risk of falling and sustaining~     another hip fracture compared with age-matched adults who did not fracture. Although exercise~     is key to reversing this pattern, there have been very few trials that aimed to improve~     muscle strength and balance as well as enhance bone health following hip fracture. Therefore,~     we propose to conduct an RCT that delivers either 12 months of standard care or standard care~     plus graduated exercise program for older women who have sustained a recent hip fracture.~   "
211285|NCT00795015|"~     The investigators are testing whether a written protocol or a computerized program can more~     effectively control blood glucose after surgery.~   "
211286|NCT00795002|"~     This randomized phase II trial is studying two different schedules of alvocidib to compare~     how well they work when given together with cytarabine and mitoxantrone in treating patients~     with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib,~     cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. It is not yet known which~     schedule of alvocidib is more effective when given together with cytarabine and mitoxantrone~     in treating patients with acute myeloid leukemia.~   "
211287|NCT00794989|"~     RATIONALE: Ground flaxseed may prevent breast cancer in premenopausal women at increased risk~     of developing primary breast cancer.~      PURPOSE: This randomized clinical trial is studying how well flaxseed works in preventing~     breast cancer in premenopausal women at risk of breast cancer.~   "
211288|NCT00794976|"~     The objective of this study is to determine the safety and efficacy of a dexamethasone~     iontophoretic transdermal patch for the treatment of pain associated with lateral~     epicondylitis (tennis elbow).~   "
211289|NCT00794963|"~     Schizophrenia patients treated with clozapine have a high prevalence of obesity-related~     metabolic syndrome. The condition is often poorly treated and may lead to the emergence of~     coronary heart disease and type 2 diabetes. The study will investigate whether structured~     treatment provided at the site of the outpatient psychiatric clinic of metabolic syndrome in~     this population will decrease the severity of metabolic syndrome as compared with usual care~     received by these patients in the community.~   "
212129|NCT00783718|"~     The primary purpose of this study was to determine the effect of vedolizumab induction~     treatment on clinical response at 6 weeks and to determine the effect of vedolizumab~     maintenance treatment on clinical remission at 52 weeks.~   "
211290|NCT00794950|"~     A majority of patients with bladder cancer have disease confined to the inner lining of the~     bladder. Patients with high risk features (high grade tumors, tumors invading into a deeper~     superficial layer) are routinely treated with Bacillus Calmette Guerin (BCG) instilled in~     their bladder after the tumor has been removed. While up to 55% of patients respond to BCG,~     failure to respond may suggest a more aggressive tumor that requires more definitive therapy~     with complete bladder removal. BCG is believed to work by stimulating the body's own immune~     system to attack tumor cells. It may also work by blocking the machinery that tumors use to~     grow blood vessels which fuel tumor growth. A newer oral drug, sunitinib has shown to help~     patients with metastatic bladder cancer by blocking new blood vessel growth (VEGF~     inhibition). The investigators are studying the use of BCG followed by sunitinib in patients~     with high risk non-muscle invasive bladder cancer to evaluate the complete response (no~     visible evidence of tumor in the bladder) at 3 months and 6 months. The investigators will~     also evaluate whether there is recurrent tumor at three years.~   "
211291|NCT00794924|"~     Probiotics have been shown to reduce the rate of diarrhea and constipation. The purpose of~     this study was to investigate if probiotics could improve outcome of hospitalized orthopedic~     elderly patients.~   "
211292|NCT00794911|"~     The main purpose of this study is to determine whether psychological intervention is~     effective in improving quality of life, mood, and relationships among adults with hepatitis C~     virus and cirrhosis awaiting liver transplantation.~   "
211293|NCT00794898|"~     This is an open-label program of Remicade in the treatment of patients with active rheumatoid~     arthritis (RA) despite treatment with methotrexate (MTX) to determine the onset of efficacy~     of infliximab.~   "
211294|NCT00794885|"~     The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more~     effective in preventing stroke among the patients with primary hypertension when compared to~     enalapril maleate.~   "
211295|NCT00794872|"~     Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD)~     and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex~     sensitivity (CHRS) has been attributed to an increased sympathetic activity. The aim of the~     present study is to examine whether chemosensor function is altered in patients with stage 3~     and stage 4 CKD.~   "
211296|NCT00794859|"~     The principal objective of the study is to investigate the effect of sorafenib on progression~     free survival (time until the cancer begins to grow again,) in patients with malignant~     mesothelioma who have had prior treatment with chemotherapy. Effectiveness of the drug will~     also be explored with PET scans before and during treatment.~   "
211297|NCT00794846|"~     This was a crossover study designed to see if patients with allergy symptoms preferred~     Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec~     treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by~     7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked~     questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.~   "
211298|NCT00794820|"~     Primary Objective:~        -  To evaluate the efficacy (combined morphologic and flow remissions) of a combination of~          fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL.~      Secondary Objective:~        -  To evaluate remission duration and survival.~   "
211299|NCT00794807|"~     Previous Biogen studies have provided experience with the tolerability, immunogenicity, and~     efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage,~     experience in larger studies, as well as the FDA-approved labeling, is confined to treatment~     courses of 12 weeks. The purpose of the present study is to offer an extended course of~     therapy with alefacept.~   "
211300|NCT00794794|"~     This study was conducted to compare the taste acceptability of Zyrtec syrup with~     desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each~     syrup, separated by 15 to 20 minutes on a single day.~   "
211301|NCT00794781|"~     The purpose of this study is to determine the maximum tolerated dose (MTD), safety,~     tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of E6201~     in subjects with advanced solid tumors.~   "
211302|NCT00794768|"~     This was a crossover study designed to see if patients with seasonal allergy symptoms~     preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or~     Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given),~     followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients~     were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.~   "
211303|NCT00794755|"~     The main objective of this study is to assess the effectiveness of low dose Vitamin K1 (200~     micrograms per day) at improving anticoagulation control in unstable patients on warfarin.~     This study will also aim to look at effectiveness in the context of genes known to influence~     warfarin metabolism, variability in the consumption of Vitamin K rich foods, and patient~     knowledge about warfarin anticoagulation -- factors which have been associated with~     anticoagulation control and which can influence the effectiveness of this intervention in~     clinical practice.~   "
211304|NCT00794742|"~     The purpose of this study is to test the resistance of pathogenic bacteria in infected~     tissues of burn patients to various antimicrobials and enzyme debriders.~   "
211305|NCT00794729|"~     This is a sub-study of a drug development study conducted by Pfizer, Inc. It will evaluate~     how well people who participate in research studies understand from the study consent form~     what the purpose of the study is, the risks and benefits of participating, the procedures~     they will undergo and their right to withdraw from the study before it ends. It will compare~     the understanding and satisfaction of those who are given a standard consent form with those~     who are given a simpler, concise consent form and examine how their understanding of the~     information is affected by the length, complexity, format, and reading level of the document.~      People 18 years of age and older who are participating in a Pfizer drug development study and~     who are able to read and write English may be eligible for this sub-study.~      Participants in Pfizer's drug development study who agree to participate in this sub-study~     are randomized to receive either the standard consent form or the concise consent form. The~     standard consent consists of a detailed, multiple page consent form. The concise form is~     simpler, written at a lower reading comprehension level. Both forms contain all of the~     required elements of informed consent according to federal regulations, and include~     information needed to make a decision about participating in the study. Each form also~     contains information regarding participation in this sub-study. The standard group signs the~     standard consent form; the concise group is given the standard consent after reviewing the~     concise form and is asked to review and sign it.~      After reviewing the consent form for the main study, participants complete a 20-minute~     questionnaire that includes questions that measure understanding of study information such as~     its purpose, risks and benefits, compensation schemes, and other information. Additional~     questions ask about how the participants made the decision to enroll in the study.~   "
216899|NCT00720265|"~     To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf~     and MR4 in new kidney transplant recipients~   "
211306|NCT00794716|"~     This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of~     steatohepatitis using fatty liver disease as the comparator group. In addition, the~     sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared~     to results from the standard laboratory tests, elastography, tests of metabolic markers and~     serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD~     patients. Patients will be included if they have clinical evidence of fatty liver disease and~     have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood~     tests and scans of the liver.~   "
211307|NCT00794703|"~     The objective of this study is to compare the efficacy and safety between Mycamine and~     Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant~     blood diseases) or allogeneic hematopoietic stem cell transplant patients~   "
211308|NCT00794690|"~     Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective~     in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent~     case reports pointed to potential toxicity of black cohosh on the liver. The investigators~     are trying to verify or refute such allegations.~   "
211309|NCT00794677|"~     The purpose of this study is to test the effects of Zetia™ (ezetimibe) 10 milligrams (mg) on~     the absorption of oxysterol into the blood following a meal containing oxysterol.~   "
211310|NCT00794664|"~     The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for~     26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated~     lipid-lowering regimen and who are not on apheresis.~   "
211311|NCT00794651|"~     Develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis~   "
211312|NCT00794638|"~     The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab~     to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended~     dose for the Phase II clinical trial.~   "
211313|NCT00794625|"~     This study will determine the advantages and disadvantages of adding one of two different~     types of drugs to stimulant treatment for reducing aggressive behavior in children with~     attention deficit with hyperactivity disorder (ADHD).~   "
211314|NCT00794612|"~     The purpose of this study is to prove the safety of the gynaecological formulation in normal~     conditions of use.~   "
211315|NCT00794599|"~     This was a crossover study designed to see if patients with allergy symptoms preferred~     Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec~     treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by~     7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked~     questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.~   "
211316|NCT00794586|"~     The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of~     fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for~     Inhalation (AZLI) in patients with cystic fibrosis and Pseudomonas aeruginosa lung infection.~   "
211317|NCT00794573|"~     The EVITA study is a clinical trial that will test the effect of varenicline (Champix™), a~     new drug used to help people quit smoking, in patients who have suffered a heart attack.~     Varenicline has been recently shown to increase the number of otherwise healthy people who~     quit smoking compared to placebo (sugar pill). Although varenicline has been shown to reduce~     smoking in healthy populations, its effectiveness in patients recovering from a heart attack~     is unknown. The EVITA trial will help answer this question.~      A total of 300 patients who have recently suffered a heart attack and are active smokers will~     be recruited in the study. For twelve weeks, half the patients will receive varenicline and~     the other half will receive placebo pills. Patients will be followed for a period of 12~     months. During this time, patients will receive telephone calls and go to clinic visits in~     order to assess if they are smoking. These follow-ups will also assess any side effects and~     clinical events such as another heart attack or hospitalization that patients may have had.~     Smoking cessation will be checked using exhaled carbon monoxide readings and self-reports.~      The EVITA trial will be the first study to examine the use of varenicline in patients who~     have recently had a heart attack. These patients, if they continue to smoke, are at high risk~     of having another cardiac event. If varenicline is shown to be useful in this population, it~     will have a major impact on prevention of cardiac events in patients who have suffered a~     heart attack.~   "
211318|NCT00794560|"~     There is very little data available on compliance with self-injected low molecular weight~     heparins (LMWH), but what there is, definitely shows that compliance represents a significant~     problem. We therefore aim to a) record drug use problems of patients including compliance, b)~     develop a SOP for first instruction by a pharmacist and for subsequent pharmaceutical care~     and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control)~     provided in the pharmacy to patients with a prescription for a LMWH as an outpatient~     treatment.~      Hypothesis:~      Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight~     heparins results in improved compliance, more safety and satisfaction as well as in fewer~     complications.~   "
211331|NCT00794365|"~     The primary objective of this Post-Marketing Study is to monitor the safety of a novel~     smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical~     practice for 12 weeks among Filipino smokers.~      The secondary objective is to further evaluate the effectiveness of Varenicline (Champix™) as~     an aid in smoking cessation based on the 7-day point prevalence of smoking cessation~   "
211343|NCT00794209|"~     This was an open-label, two-phase, crossover, safety, pharmacokinetic (PK), and~     pharmacodynamic (PD) study in normal, healthy, non-smoking, fasting male and female subjects.~     The first phase (A. Device Qualification Phase) of the study compared three aerosol devices~     to a reference device to identify a nebulizer that produced a favourable, clinically~     relevant, PK and PD profile of AeroLEF. The PK and PD of the test and reference devices were~     compared to 200 mcg of intravenous fentanyl administered over 1 minute.~      The second phase (B. Device Characterization Phase) of the study was planned to characterize~     and compare the safety, PK and PD of the selected aerosol device (identified in the Device~     Qualification Phase) to 300mcg of intravenous fentanyl administered over 15 minutes if a~     device was chosen during the Device Qualification Phase. The data from the selected aerosol~     device would be pooled from subjects in both the Device Qualification and Device~     Characterization Phases of the study.~   "
211319|NCT00794547|"~     According to the Cancer Atlas, lung cancer remains the major cancer among the 10.9 million~     new cases of cancer diagnosed annually worldwide. The mortality from lung cancer is greater~     than the combined mortality for breast, colon and prostate cancer combined. Most patients~     with metastatic non-small-cell lung cancer (NSCLC) are treated with platinum-based~     chemotherapy regimens. The drug combination of cisplatin and docetaxel is one of the commonly~     used regimens in metastatic NSCLC. Although both drugs are powerful disruptors of cell~     growth, positive therapeutic response rates to this therapy remain low for NSCLC patients,~     from 25% to 30%. While adding new biologics such as bevacizumab to the current treatment~     standard can improve treatment response, median survival for advanced NSCLC patients~     receiving this type of treatment remains low at under 12 months. Research studies have~     demonstrated that Vitamin D, and it's signaling pathways are important biological targets in~     cancer therapeutics. In vitro and in vivo calcitriol (1, 25 dihydroxycholecalciferol) is~     antiproliferative and potentiates the antitumor effects of cytotoxic agents (e.g. taxanes,~     platinum analogues). We have shown that administration of high doses of calcitriol and~     cisplatin is feasible and associated with complete tumor regressions in dogs with spontaneous~     cancers. Calcitriol has also shown to be synergistic with docetaxel both in preclinical as~     well as in a recent phase II clinical trial in prostate cancer. Based on these results and~     other supporting data from studies indicating that calcitriol functions as a potent and well~     tolerated anti-tumor agent when used in combination with drugs likes cisplatin and docetaxel,~     we hypothesize that introducing calcitriol into treatment regimes for NSCLC patients has the~     potential to demonstrably improve treatment response for these patients. The overall goals~     for conducting this phase I/II clinical study will be (1) to determine the maximum tolerated~     dose (MTD) and dose limiting toxicities (DLT) of calcitriol in combination with~     cisplatin/docetaxel in patients with advanced NSCLC, (2) to assess the response rates of~     patients with advanced NSCLC to the combination of calcitriol with cisplatin/docetaxel, (3)~     to evaluate the pharmacokinetics (PK) of administering calcitriol intravenously at the MTD,~     and (4) to evaluate correlations between calcitriol PK and changes on specific coding regions~     of the gene associated with calcitriol breakdown.~   "
211320|NCT00794508|"~     Severe combined immune deficiency (SCID) may result from inherited deficiency of the enzyme~     adenosine deaminase (ADA). Children with ADA-deficient SCID often die from infections in~     infancy, unless treated with either a bone marrow transplant or with ongoing injections of~     PEG-ADA (Adagen) enzyme replacement therapy. Successful BMT requires the availability of a~     matched sibling donor for greatest success, and treatment using bone marrow from a less-well~     matched donor may have a higher rate of complications. PEG-ADA may restore and sustain~     immunity for many years, but is very expensive and requires injections 1-2 times per week on~     an ongoing basis. This clinical trial is evaluating the efficacy and safety of an alternative~     approach, by adding a normal copy of the human ADA gene into stem cells from the bone marrow~     of patients with ADA-deficient SCID. Eligible patients with ADA-deficient SCID, lacking a~     matched sibling donor, will be eligible if they meet entry criteria for adequate organ~     function and absence of active infections and following the informed consent process. Bone~     marrow will be collected from the back of the pelvis from the patients and processed in the~     laboratory to isolate the stem cells and add the human ADA gene using a retroviral vector.~     The patients will receive a moderate dosage of busulfan, a chemotherapy agent that eliminates~     some of the bone marrow stem cells in the patient, to make space for the gene-corrected~     stem cells to grow once they are given back by IV. Patients will be followed for two years to~     assess the potentially beneficial effects of the procedure on the function of their immune~     system and to assess possible side-effects. This gene transfer approach may provide a better~     and safer alternative for treatment of patients with ADA-deficient SCID.~   "
211321|NCT00794495|"~     This was a crossover study designed to see if patients with allergy symptoms preferred~     Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec~     treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by~     7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked~     questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.~   "
211322|NCT00794482|"~     This is a multi-centre, multi-national, open study to assess the pharmacokinetics of NRL972~     in patients with hepatic cirrhosis CTP-classes A, B, and C (histologically confirmed by liver~     biopsy). The pharmacokinetics of NRL972 will be referenced to a Clinical Staging Matrix~     obtained during a clinical work-up of patients with hepatic cirrhosis. Patients to be studied~     will have histologically established hepatic cirrhosis or confirmed hepatic cirrhosis by an~     objective imaging study without confounding end-stage co-morbidity. Within 14 days of~     confirming eligibility, the investigations will be conducted over 2-5 days with the test~     procedures (clinical laboratory tests, ultrasound (US)-investigations, gastroscopy, NRL972-~     and MEGX'-test). Up to one week after the NRL972-test, a follow-up telephone call will be~     made.~   "
211323|NCT00794469|"~     Drinking water is largely advocated for obesity prevention and management. Recent studies~     have suggested that water has a thermogenic effect, this has not been examined in children.~     In this study, we will measure the resting metabolic rate of 21 obese children before, and~     during drinking cold (4 degrees centigrade)water for up to 60 minutes.~   "
211324|NCT00794456|"~     Phase III, multicentric, double blind, randomized study, controlled by Valeriana officinalis~     for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L~     and Salix alba L. on mild and moderate anxiety. The treatment period will last 6 weeks and be~     followed by a post treatment visit.~      Hamilton anxiety scale will be used to assess anxiety.~   "
211325|NCT00794443|"~     This is a multi-center double-blind parallel-group study in involutional osteoporosis~     patients to compare the efficacy and safety of monthly oral intermittent formulation~     ONO-5920/YM529 with its daily formulation.~   "
211326|NCT00794430|"~     Randomised, double-blind, placebo-controlled, parallel group, multicentre study of oral doses~     of V3381, titrated to effect. A 2-week single-blind run-in period will be followed by a 13~     week double-blind titration and maintenance phase. Doses will be titrated up in 100 mg bid~     increments every one or two weeks, starting from 100 mg bid. A 2 week follow-up period will~     conclude patient participation in the study.~   "
211327|NCT00794417|"~     The purpose of the study is to determine whether the combination of aflibercept, pemetrexed~     and cisplatin is safe and effective.~   "
211328|NCT00794404|"~     The purpose of this study is to evaluate the interest of enthesis sonography for the~     diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical~     symptoms suggestive of spondylarthritis~   "
211329|NCT00794391|"~     The purpose of this study is to evaluate the effects of a brief motivational intervention in~     reducing risky injection practices among injecting drug users (IDUs). The investigators~     hypothesis is that motivational intervention will be more effective than educational~     intervention in reducing risky injection practices among IDUs.~   "
211330|NCT00794378|"~     This study was conducted to compare the taste acceptability of Zyrtec syrup with~     desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each~     syrup, separated by 15 to 20 minutes on a single day.~   "
211332|NCT00794352|"~     Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple~     sclerosis, may be related to problems with an individual s immune system. However, more~     information is needed on the ways in which the cells of the immune system interact with the~     central nervous system (CNS). This study will compare tests performed on both healthy~     volunteers and individuals who have signs or symptoms of immune-related damage to their CNS.~      This study will include two groups of subjects at least 12 years old. Subjects will either~     have symptoms of immune-related CNS damage, or will be healthy volunteers selected for~     comparison purposes.~      Study participants will visit the NIH Clinical Center on an outpatient basis for an initial~     evaluation visit. During the visit, patients will provide a comprehensive medical history and~     undergo a neurological examination, and will provide blood samples for research purposes. The~     healthy volunteers will be asked to schedule a return visit for a magnetic resonance imaging~     (MRI) procedure, and may be asked to undergo other tests requested by the study researchers~     on an as-needed basis. The group of patients with symptoms of immune-related CNS damage will~     be asked to undergo a series of tests, including the following:~        -  MRI procedures, with a minimum of three brain MRIs and one spinal cord MRI taken~          approximately 4 weeks apart~        -  A diagnostic lumbar puncture, performed on an outpatient basis~        -  Tests of brain and vision activity~        -  Additional blood and tissue samples~      All study participants will return for a followup visit 1 year after the initial evaluation~     visit. Patients with symptoms of immune-related CNS damage may be offered the opportunity to~     participate in additional followup tests with NIH researchers.~   "
211333|NCT00794339|"~     RATIONALE: Diagnostic procedures, such as copper Cu 64-ATSM PET/CT scans, may help doctors~     predict how patients will respond to treatment.~      PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in~     predicting disease progression in patients undergoing standard of care treatment with~     cisplatin and radiation therapy (external beam and brachytherapy) per NCCN guidelines for~     newly-diagnosed stage IB, stage II, stage III, or stage IVA cervical cancer.~   "
211334|NCT00794326|"~     The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis~     (PD) solution PDsol 12 in comparison with a conventional, already marketed solution,~     Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim~     to decrease hypertension and to improve the sodium/water balance.~   "
211335|NCT00794313|"~     Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and~     uncontrolled movements called dyskinesias. A drug called amantadine can reduce these~     movements. To date, there are no objective measures of these movements. The purpose of this~     study is to measure the reduction of the movements by amantadine and/or topiramate using an~     objective measure.~   "
211336|NCT00794300|"~     The myocardial salvage assessed by using multimodal cardiac magnetic resonance imaging is a~     rather new technique which can be used as a surrogate endpoint to reduce the sample size in~     studies comparing different reperfusion strategies in myocardial infarction. As~     reproducibility of myocardial salvage has not been evaluated appropriately, we aim to scan 20~     patients on 2 subsequent days to evaluate reproducibility of myocardial salvage index.~   "
211337|NCT00794287|"~     To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom~     is able to neutralize the allergen, and therefore to prevent a positive CAST~   "
211338|NCT00794274|"~     To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic~     cutaneous sarcoidosis.~   "
211339|NCT00794261|"~     The purpose of this study is to evaluate the efficacy and tolerance of a single~     administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose~     chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred.~      Eligible patients will be randomized. The estimated inclusion period is approximately 18~     months. The duration of the research is 22 months. The maximum duration of participation for~     each patient is 3 months.~      The number of patients required in this multicentric and prospective study is 150 (13~     participating centers).~      This is a phase II, controlled, randomized, non comparative and open-label multicentric~     study.~   "
211340|NCT00794248|"~     This was a crossover study designed to see if patients with seasonal allergy symptoms~     preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or~     Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given),~     followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients~     were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.~   "
211341|NCT00794235|"~     Investigation of the metabolic activity of sorafenib and sorafenib plus dacarbazine on~     melanoma metastasis in patients with melanoma stage III or IV on the basis of PET/CT, LDH and~     S-100 evaluation. As we hypothezise a direct influence on the transcriptome by these drugs~     via antiproliferative or apoptotic signals, biopsies of melanoma skin metastases will be~     assessed with microarrays and direct changes will be revealed. If positive effects on the~     transcriptional profiles of metastases are revealed, patients with metastatic melanomas would~     benefit from these drugs resulting in tumor regressions.~      Therefore, a total of 12 patients with skin- or superficial lymph node metastases with a~     diameter of at least 1 cm will be chosen for sorafenib therapy over 56 days per os twice~     daily with each 400 mg and, additionally, on day 14 and 42, intravenous dacarbazine infusion~     (volume depending on the body surface area (1000 mg/m2)). Before treatment with sorafenib,~     before treatment with dacarbazine, and after treatment, S100 and LDH will be measured in~     serum, PET/CT will be conducted and biopsy will be taken out of one skin metastasis on the~     same day.~   "
211342|NCT00794222|"~     The mobiletype program is a mental health assessment and monitoring tool that runs on mobile~     phones.~      The program assesses the general mental health of young people in real-time and transmits~     this data to a website to be reviewed by their general practitioner (GP) in consultation with~     their patient. The website consists of individualised feedback reports for each participant,~     and graphical displays of the monitoring data. The primary aims of the current project are to~     examine: (1) whether the process of self-monitoring via the mobiletype program increases~     young people's awareness of their mood and reduces depressive symptoms and (2) whether~     emotional self-awareness mediates the relationship between self-monitoring and depressive~     symptoms.~   "
223712|NCT00630383|"~     The aim of the study is to determine whether controlled infection with a clinically safe~     number of larvae of hookworm results in an immune response that is protective in relapsing~     MS.~   "
211348|NCT00794144|"~     The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine~     Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2~     to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics~     (study of the action of a drug in the body) in these children~   "
211349|NCT00794131|"~     The main purpose of this study is to determine whether, GL-ONC1, an Oncolytic Virus, can~     safely be administered intravenously in patients with advanced solid tumors.~   "
211350|NCT00794118|"~     The primary purpose of this observational study is to describe and define the current daily~     practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be~     collected only from subjects providing informed consent.~   "
211351|NCT00794105|"~     Observation of fluid behavior over a perforated eardrum.~      A comparison of the behavior of the gas in normal vs. different kinds of otitis media ears.~   "
211352|NCT00794092|"~     Abdominal aortic aneurysm (AAA) is a progressive enlargement of the aorta, the largest blood~     vessel in the body. It is at risk of bursting when it is usually fatal. Currently the risk of~     the AAA bursting is estimated from its diameter. In this study, the investigators hope to~     develop a new type of aneurysm scan involving Magnetic Resonance Imaging (MRI). It is hoped~     that this scan will be better at determining which AAAs are at risk of bursting and therefore~     require an operation to prevent this.~   "
211353|NCT00794079|"~     The purpose of this study is to determine whether omega-3 fatty acid supplementation~     influences muscle protein synthesis rates in young and older adults.~   "
211354|NCT00794066|"~     Purpose:~      To assess the prevalence of peripheral arterial disease (PAD) in acute stroke patients.~      Interventions:~      Assessment of the ankle brachial index using the boso-ABI-system 100 (www.boso.de).~      Design:~      Prospective, open, cohort study.~      Study size planned:~      1500.~      Follow-up duration:~      3 months.~   "
211355|NCT00794053|"~     Detection of lymph nodes starting to be involved by cancer spreading from the thyroid gland~     during operation is useful. It saves the patient from having a second operation to remove~     these nodes later on when they become obvious. The problem is that there are many lymph nodes~     around the gland. The theory is that only one node will get the first spill of the tumour~     cells.~      In this study the investigators are trying to use an inert colored material to inject into~     the tumour. This should run in the same path as the tumour cells and should therefore stain~     the one lymph node that will be affected first should the tumour spread.~      The stained lymph node is excised and examined instantaneously for tumour affection. If it is~     found to be affected by the tumour, then the operation is extended to include removal of all~     its fellow lymph nodes. If it is found to be free from the tumour, then this patient does not~     have tumour spread.~   "
211356|NCT00794040|"~     Severe mood dysregulation (SMD) is a very common syndrome in children. Its symptoms include~     very severe irritability, including persistent anger and frequent outbursts, as well as~     distractibility, hyperactivity, and other symptoms of attention deficit hyperactivity~     disorder (ADHD). Many children with SMD receive the diagnosis of bipolar disorder (BD) in the~     community, although they do not have clear manic episodes (with symptoms such as extreme~     happiness and decreased need for sleep). Because SMD has not been studied in depth, we do not~     know which medications are most helpful to those with SMD. This study will evaluate the~     effectiveness of the stimulant medication methylphenidate (MPH, more commonly known as~     Ritalin ) when combined (or not combined) with the antidepressant citalopram (Celexa ) in~     treating symptoms of SMD in children and adolescents. This study will provide information~     about how to treat SMD in youth.~      This study will include approximately 80 patients between 7 and 17 years of age with SMD. The~     patient s symptoms must have started before age 12.~      The study will consist of four phases carried out over 4 to 5 months. During Phase 1, the~     patient will undergo blood and urine tests, and will gradually taper off his or her~     medication. The duration of this phase depends on the patient s medication before starting~     the study. In Phase 2, the patient remains off all medication for 1 week. In Phase 3, the~     patient will be treated with MPH for 2 weeks, and then will be randomly assigned to receive~     either MPH plus citalopram or MPH plus a placebo for a further 8 weeks. In Phase 4, the~     researchers will evaluate the effectiveness of the medications taken, and begin an open~     treatment phase using medications that they deem appropriate for that patient (this may~     include MPH with citalopram and/or other medication combinations).~      Most patients will be admitted to the Pediatric Behavioral Health Unit at the National~     Institutes of Health Clinical Center during the medication withdrawal part of the study~     (Phases 1 and 2). From Phase 3 on, a patient may participate as an inpatient, outpatient, or~     in day treatment, depending on what is in his or her best interests.~   "
211357|NCT00794027|"~     The proposed research will investigate the clinical outcomes associated with a modified yoga~     training program in patients with heart failure (HF). HF patients (15-20) will participate in~     a modified yoga program during an 8 week period, two times per week with instruction for home~     practice. Baseline measures and follow-up will be taken after 8 weeks. The underlying~     hypothesis to be tested is that yoga-induced improvements in nervous system and skeletal~     muscle function will yield positive effects on clinical outcomes, functional ability, and~     health-related quality of life in patients with HF.~      The effect of combined yoga and breathing training on the natural history of HF and its~     potential to decrease negative clinical outcomes and improve symptoms is unknown. The~     relevance of this research is related to the important information it will provide to~     clinicians caring for patients with HF and will be the basis for pilot data for future NIH~     funding applications.~   "
211358|NCT00794014|"~     The purpose of this study is to establish the optimal strategy for side branch stenting in~     coronary bifurcation lesion.~   "
211359|NCT00794001|"~     Part I (Pilot Phase): The purpose of this study is to examine if formalized data assessment~     and systematic feedback improves treatment times (i.e. contact-to-balloon time and~     door-to-balloon time) in patients with myocardial infarction with ST-segment elevation~     (STEMI).~      Part II (Implementation Phase): The Purpose is to prospectively investigate if survival can~     be improved by stringent use of this concept of formalized data analysis and systematic~     feedback of procedural and clinical data to all participating physicians and other members of~     the STEMI patients treating personnel.~   "
211360|NCT00793988|"~     Aim of study is to investigate whether a small, non-invasive vibrating device applied to the~     forehead during local anaesthetic administration reduces the pain of the injection.~   "
211361|NCT00793975|"~     The purpose of this study is to determine if IMC-1121B is safe for patients, and to determine~     the best dose of IMC-1121B to give to patients.~   "
211362|NCT00793962|"~     The purpose of this study is to compare the efficacy and toxicities of hypofractionation~     radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated~     with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the~     two groups.~   "
218483|NCT00699335|"~     The aim of the study was to evaluate the efficacy and safety of Matrifen® in patients with~     severe and chronic pain who could only be sufficiently treated with opioid analgetics (WHO~     class 3).~   "
211364|NCT00793923|"~     The primary objective of this proposed research study is to evaluate the safety of~     intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to~     intravitreal ranibizumab alone in the treatment of wet ARMD. The addition of the broad~     spectrum anti-inflammatory activity of dexamethasone may augment the anti-VEGF activity of~     ranibizumab by amelioration of inflammation existing in the microenvironment of the choroidal~     neovascularization. While the anti-VEGF agents have proven to be very efficacious in the~     treatment of exudative ARMD, their narrow target and window of activity may limit their~     overall durability of action.~   "
211365|NCT00793910|"~     The purpose of this study is to determine the effectiveness of an oral medication called~     gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess~     the frequency of use of rescue medication interventions, defined as non-steroidal~     anti-inflammatory (NSAID) eye drops and oral narcotic medication.~   "
211366|NCT00793897|"~     A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and~     preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs,~     paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. In~     addition, the study is expected to identify the recommended dose or dose range of BMS-754807~     in combination with paclitaxel and carboplatin for Phase 2 studies~   "
211367|NCT00793884|"~     Latinos represent the largest minority group in the United States with a population of 35~     million or 12.5%. National surveys indicate that the prevalence of type 2 diabetes is 1.9~     times higher in Latinos than non-whites, and that approximately 24% percent of Latinos over~     the age of 45 years have diabetes. In Georgia, Latinos make up approximately 6.5% of the~     population. During 1990 and 2000, the prevalence of diabetes in Fulton and Dekalb counties,~     two of the most populated areas in Georgia and the Atlanta metropolitan area increased by~     30%. Language and cultural barriers represent the two most important obstacles in educating~     and improving the care of Latino patients with diabetes. Less than 5% of physicians, 2% of~     nurses, and 2.5% of dentists in the US speak Spanish.~      The Emory Latino Diabetes education program has been in existence since December 2005. Our~     program aims to deliver diabetes education in Spanish to the underserved Latino community in~     Metro Atlanta. Program participants attend an initial 2.5hr diabetes education class in~     Spanish. The class curriculum follows the American Association of Diabetes Educators (AADE)~     seven self-care behaviors: healthy eating, being active, monitoring, medication use,~     problem-solving and healthy coping. Participants are invited to return to a follow-up session~     within 6 months. Follow-sessions are held in the late afternoon. These sessions are~     discussion-based and include an activity such as salsa lessons and cooking demonstrations.~      We would like to obtain IRB approval to analyze and publish that data we collect during our~     educational sessions. We would like to collect retrospective data from past participants in~     the program (for which we request a waiver of informed consent and HIPAA authorization), and~     we would like to consent current and future participants to use their data.~   "
211368|NCT00793871|"~     To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With~     Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.~   "
211369|NCT00793858|"~     The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide)~     absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose~   "
211370|NCT00793845|"~     The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCR in~     children with high-risk neuroblastoma. In the present study, a single arm trial of tandem~     HDCT/ASCR will be carried out. In the present study, the investigators will investigate~     whether tandem HDCT/ASCR might improve the survival of patients with high-risk neuroblastoma~     with acceptable toxicity.~   "
211371|NCT00793832|"~     It is hypothesized that the patients in the EXDA group will be able to complete a structured~     exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that~     the structured endurance activity will increase their physical fitness and total daily energy~     expenditure compared to the DA group.~   "
211372|NCT00793819|"~     Silodosin is compared to placebo to determine if it is safe and effective for the treatment~     of nighttime urination (nocturia) in men with BPH~   "
211373|NCT00793806|"~     The common causes of mortality are late stages of chronic kidney disease, cardiovascular~     disease and infections, are associated with abnormalities of the immune system, an underlying~     state of chronic inflammation and oxidative stress. These processes have not been carefully~     described in the chronic kidney disease population. The researcher can use Diffuse Optical~     Spectroscopy to determine the immune system in individuals with chronic kidney disease and~     describe the association with chronic inflammation and oxidative stress in that population.~   "
211374|NCT00793793|"~     This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA~     in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA~     combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients;~     or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced~     patients.~      A secondary objective is to investigate antiviral activity, potential drug-drug interactions~     and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for~     treatment-naïve patients.~   "
211375|NCT00793780|"~     The purpose of this clinical trial is to find out how effective low dose oral naltrexone is~     on reducing body weight when compared to placebo in women with schizophrenia and~     schizoaffective disorder.~   "
211376|NCT00793767|"~     Recently EPO receptors have been found in human muscle tissue, but what is still not known is~     the physiological role of these receptors. In this study the researchers want to investigate~     if there is any effect of a acute administration of EPO on insulin resistance and/or~     substrate metabolism in muscle tissue.~   "
211389|NCT00793598|"~     Twelve renal transplant subjects and twelve hematopoietic stem cell recipients will be~     enrolled in Cohort 3A. Subjects enrolled in Cohort 3A will receive 40mg CMX001 or placebo~     once weekly for a total of 5 doses. After 12 renal subjects have been enrolled into Cohort~     3A, up to three additional cohorts (4A, 4B and 4C) of 12 renal transplant subjects each may~     be enrolled in a sequential manner~   "
211390|NCT00793585|"~     This prospective, randomized controlled study will evaluate the effect of uric acid on the~     progression of IgA nephropathy.~   "
211377|NCT00793754|"~     Despite formal recommendations, evidence of efficacy of aspirin in individuals with diabetes~     is scant and controversial. While the efficacy of aspirin versus placebo in patients with~     diabetes is currently under investigation in big randomized controlled trials, the putative~     additive effects of aspirin and statins in this population remain to be investigated.~     Moreover there are no data examining the pathophysiologic means by which aspirin with or~     without statins affects thrombosis in diabetic patients.~      The aim of this trial is to evaluate the efficacy of low-dose aspirin (100 mg/daily),~     statins, both or neither for the reduction of thrombin generation. These preventive~     strategies will be evaluated on the top of the other strategies aimed at optimizing the care~     of diabetic patients in terms of metabolic control and control of the other cardiovascular~     risk factors.~   "
211378|NCT00793741|"~     The purpose of this study is to determine whether islet transplantation alters brain glucose~     concentrations in patients with type 1 diabetes, recurrent hypoglycemia, and hypoglycemia~     unawareness when compared to that measured prior to transplant in the same subjects.~   "
211379|NCT00793728|"~     This study compares if there is any difference doing antrectomy while performing a sleeve~     gastrectomy for treating morbid obesity. The investigators compare the differences between~     leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of~     life.~   "
211380|NCT00793715|"~     Decompressive laparotomy with temporary abdominal closure, will decrease of overall mortality~     and major morbidity in patients with abdominal compartment syndrome during acute pancreatitis~     in comparison with percutaneous puncture with placement of abdominal catheter.~   "
211381|NCT00793702|"~     The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of~     the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary~     objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when~     injected twice with time intervals of 6 or 12 weeks to healthy adults.~   "
211382|NCT00793689|"~     In the study will be included patients that have undergone total thyroidectomy and do not~     display obvious clinical or laboratory hypoparathyroidism. On the third postoperative day and~     before the patient's exit from the hospital, the patient will undergo an intravenous infusion~     test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. Three months after~     the operation, if the study conditions are still met, the patient will undergo an additional~     parathyroid hormone (PTH) measurement and sodium bicarbonate infusion test and the~     parathyroid function will be evaluated again.~   "
211383|NCT00793676|"~     The G protein-coupled receptors (GPCRs) are a family of proteins expressed at the cell~     membrane. They are composed of 380 members involved in the important functions of the~     organism and are privileged therapeutic targets.Their expression is highly modulated~     depending on the metabolic state of the cells, in particular in pathological situations.our~     study proposes to determine whether GPCR expression modulation could be used as a biomarker,~     either prognostic or diagnostic, of treatments.To do so , the investigators will determine~     the expression profile of the 380 human GPCRs in human blood cell samples in two chronic~     inflammatory pulmonary diseases : asthma and COPD (chronic obstructive pulmonary disease ) .~     These have opposed inflammatory infiltrates : asthma is associated with eosinophil and Th2~     lymphocyte infiltration whereas COPD shows neutrophils and macrophages within the airways~     with a Th1 lymphocytic population. The GPCR signature (transcriptomic) will be determined on~     total white blood cells as well as on isolated mono- and poly-nuclear populations obtained~     from healthy subjects and patients selected at the asthma or COPD consultation. The~     expression profiling analysis will reveal sub-groups of GPCRs whose expression is modified in~     disease. The specificity of the variation of expression of these biomarker sub-populations~     will be determined, by a study recruiting a hundred patients and controls per disease on this~     restraint number of genes. The outcomes of the project will lead to establish GPCR identity~     cards for these chronic inflammatory diseases, which might therefore be used as diagnostic~     or prognostic biomarkers to follow the evolution of a disease or the efficacy of a given~     treatment. In addition, detailed analysis of the identified GPCRs will lead to propose new~     therapeutic targets for inflammatory diseases. This study has therefore the objective of~     validating GPCRs as potential biomarkers for inflammatory diseases.~   "
211384|NCT00793663|"~     The purpose of this study is ad 1) to measure the depth of hypnosis as assessed by BIS and~     cAAI during an average general anesthesia with xenon or sevoflurane and to establish a~     reliable monitoring system for measuring and documenting the actual depth of hypnosis for the~     volatile anesthetics investigated. Ad 2) the question is to be answered whether 4 mg~     dexamethasone i.v. is an effective prophylactic treatment against postoperative nausea and~     vomiting in case of xenon or sevoflurane anesthesia. Ad 3) it serves to gain evidence about~     the (non-)effectiveness and kinetics of ondansetron as antiemetic remedy after xenon or~     sevoflurane anesthesia.~   "
211385|NCT00793650|"~     The goal of this study is to evaluate the safety of melphalan and autologous PBSCT~     (peripheral blood stem cell transplantation - stem cells that come from your own body) in~     combination with bortezomib, a new FDA approved drug used to treat myeloma.~   "
211386|NCT00793637|"~     In many cases, the existing locking bolts and screws in intramedullary nails do not provide~     sufficient stability. Due to the play between screw and nail, the reduction can be lost and~     the instability can result in malunions, nonunions, or pseudoarthrosis. Consequently,~     secondary angular fracture dislocation (defined as a difference of the angle of 10° or more~     from the post-operative to the follow-up x-rays) can be observed in approximately 30% of~     patients after conventional intramedullary nailing of proximal third tibial fractures and in~     approximately 0-2% in patients with distal third tibial fractures. Therefore, an Angular~     Stable Locking System for Intramedullary Nails (ASLS) was developed to reduce the risk of~     secondary loss of reduction by providing axial and angular stability. ASLS provides angular~     stable fixation between nails and screws with resorbable sleeves used as dowels in the nail~     locking holes.~      The present study evaluates the handling of ASLS and the surgeon's compliance as well as any~     complications occurring during the baseline and the follow-up period in patients with~     proximal and distal tibial, femoral and humeral fractures treated with intramedullary nails.~     Furthermore, the relationship of any occurred complications to ASLS will be assessed.~   "
211387|NCT00793624|"~     The primary objective of this study is to assess the long-term efficacy and safety of once~     daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat®~     inhaler, in patients with COPD.~   "
211388|NCT00793611|"~     The investigators purpose is to perform a pilot study evaluating the efficacy in hypnotherapy~     in treating women with Overactive Bladder Symptoms (urinary urgency symptoms and urinary~     frequency). Approximately half the women in the study will receive standard care~     (performing a voiding diary, Pelvic Floor exercises, and timed voiding) and the other half~     will receive standard care and 3 hypnotherapy sessions. The investigators will compare the~     groups using a validated overactive bladder questionnaire and compare voiding diaries to~     evaluate urinary frequency at the end of the sessions/study completion.~   "
211391|NCT00793572|"~     This phase II trial studies the side-effects and anti-cancer effects of giving an autologous~     or syngeneic stem cell transplant followed by an allogeneic donor stem cell transplant and~     bortezomib. Patients treated on this trial have newly diagnosed high-risk, relapsed, or~     refractory multiple myeloma (MM). Giving chemotherapy before an autologous stem cell~     transplant slows or stops the growth of cancer cells by preventing them from dividing or~     killing them. Stem cells that were harvested earlier from the patient's blood and frozen are~     then returned to the patient to replace the blood-forming cells that were destroyed by~     chemotherapy. Giving chemotherapy and total-body irradiation before an allogeneic donor stem~     cell transplant also prevents the patient's immune system from rejecting the donor's stem~     cells. Undergoing an autologous or syngeneic stem cell transplantation followed by an~     allogeneic donor stem cell transplant and bortezomib may be overall more effective in killing~     cancer cells.~   "
211392|NCT00793559|"~     terlipressin is given to refractory septic shock patients who do not respond to noradrenalin~     in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is~     better to give it by continuous drip and avoid abrupt changes in BP and heart function~   "
211393|NCT00793546|"~     This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in~     combination with exemestane versus exemestane alone. This is a 2-part study consisting of a~     safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive~     bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety~     concerns arise, then future eligible subjects will be randomly assigned to the main phase of~     the study. They will either receive bosutinib daily combined with daily exemestane, or daily~     exemestane alone for a specified period of time. Subjects will be followed up for survival~     after treatment discontinuation.~   "
211394|NCT00793520|"~     The purpose of this study is to evaluate the effect of milnacipran on how the brain processes~     pain in patients with fibromyalgia and to assess the relationship between this effect and~     brain activation patterns during functional magnetic resonance imaging.~   "
211395|NCT00793507|"~     This pilot project consists of co-locating dental hygienist services in medical primary care~     offices. Dental hygienists will work in close collaboration with the primary care offices,~     providing preventive dental care to young children either before or after scheduled~     well-child visits.~   "
211396|NCT00793494|"~     The aim of this study is to determine the efficacy of the administration of Bifidobacterium~     bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus~     Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis~     R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive~     symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome~     versus placebo.~      This study is a double-blind randomized controlled study. 84 children will included. After~     inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients~     receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are~     followed for a 2-week period of follow-up.~      4 visits and 4 phone calls are planned during the study.~   "
211397|NCT00793481|"~     Metabolic Syndrome is a highly prevalent condition that is comprised of several major~     clustering factors that increase the risk for developing cardiovascular disease. Diffuse~     Optical Spectroscopy is a non-invasively measure can show changes in the microvasculature of~     human. Diffuse Optical Spectroscopy measures the optical absorption and scattering properties~     of near-infrared light in tissues such as muscle in order to quantify the absolute~     concentration of oxygenated and deoxygenated hemoglobin, water, and lipids. It provides~     quantitative and functional information on the microvasculature related to tissue perfusion,~     metabolic changes, and indicators of tissue damage.~   "
211398|NCT00793468|"~     The purpose of this study is to determine the effect of GSK598809 as compared to placebo in~     preventing recently-quit smokers from going back to smoking.~   "
211399|NCT00793455|"~     The purpose of this study is to evaluate whether patient outreach is effective at increasing~     compliance with preventive screenings ordered by their physician. We hypothesize that~     educational outreach may increase completion rates.~   "
211400|NCT00793442|"~     The overall hypotheses of this project is that severe sepsis is associated with endothelial~     dysfunction; that endothelial dysfunction, in turn, is predictive of subsequent organ failure~     and death; and that protocolized resuscitation attenuates endothelial cell (EC) dysfunction~     and improves patient survival.~   "
211401|NCT00793429|"~     In this study healthy volunteers received increasing doses of prucalopride to study the~     tolerability and cardiac safety of prucalopride. The study hypothesis was that prucalopride~     at doses up to 10 mg has no clinically relevant effect on the cardiovascular safety in~     healthy volunteers.~   "
211402|NCT00793416|"~     The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating~     the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic~     Intracranial Hypertension (IIH) undergoing radionuclide test for suspected shunt obstruction.~     This is an exploratory study to determine how a non-invasive device can assist in detection~     of presence of flow in these patients.~   "
211403|NCT00793403|"~     This is an observational study of composite indices, including the CLARA (CLinical ARthritis~     Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy~     in order to evaluate clinical remission and low disease activity. Data will be collected only~     from patients providing informed consent. In this study we aimed to assess the psychometric~     properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that~     uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this~     index would facilitate rapid and easy RA activity assessment in daily routine.~   "
211415|NCT00793247|"~     This study was designed to investigate the clinical safety, tolerability and efficacy of~     prucalopride in improving the symptoms associated with chronic intestinal pseudo-obstruction~     (CIP) in subjects with CIP. The study hypothesis was that prucalopride at doses up to 4 mg is~     safe, well tolerated, efficacious and improves the symptoms associated with CIP.~   "
211416|NCT00793234|"~     The purpose of this study is to evaluate the safety and efficacy of a single administration~     of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.~   "
218541|NCT00698529|"~     This study will compare the effectiveness of face-to-face training versus Web-based training~     seminars in disseminating HIV prevention interventions to nongovernmental organizations in~     Eastern Europe and Central Asia.~   "
211404|NCT00793390|"~     Background:~        -  Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly~          aggressive form of breast cancer.~        -  Three characteristics of IBC tumors their rapid progression, their extensive formation~          of new blood vessels, and the fact that these characteristics are present from the~          inception of the tumor make it an ideal model for studying factors associated with tumor~          aggressiveness.~        -  This study is a collaboration among several institutions in the United States and North~          Africa that have extensive epidemiological experience and experience with IBC.~      Objectives:~      - To understand what causes certain types of breast conditions, including IBC.~      Eligibility:~      - Women 18 years of age and older with IBC and non-IBC and healthy women volunteers are~     eligible. Women who have had a previous diagnosis of any kind of breast cancer are excluded.~      Design:~        -  Participants complete a questionnaire providing information about their background,~          including medical and reproductive history, family health history and lifestyle habits~          and undergo the following additional procedures:~        -  Height, weight, hip and chest measurements.~        -  Saliva sample collection to measure biological factors that may be related to breast~          conditions.~        -  Breast examination and, if permission is given, photographs of affected breast.~        -  Analysis of biopsied tissue for genetic and biochemical factors.~   "
211405|NCT00793377|"~     The primary objective of this trial is to compare the rate of pathologically complete~     remissions achieved using a preoperative dose-intensified 8 week therapy consisting of~     adriamycin and docetaxel with a preoperative sequential 24 week regimen consisting of~     adriamycin/cyclophosphamide followed by docetaxel, in patients with operable carcinoma of the~     breast. Secondary aims are to assess disease-free and overall survival, the rate of complete~     and partial responses by palpation and imaging methods, the rate of breast-conserving~     operations, and the toxicity of the two chemotherapy regimens.~      Women meeting the following criteria will be eligible for the study: those with operable~     breast cancer (T2-3 N0-2 M0), with the diagnosis histologically confirmed by biopsy, and~     measurable disease on mammography or sonography or breast MRI (the most appropriate method~     should be chosen by the investigator). After the patients have given written informed~     consent, they will be randomly assigned to the study treatments. Patients in group I will~     receive four cycles of combination chemotherapy consisting of adriamycin 50 mg/m2 (15 min~     i.v. infusion) and docetaxel 75 mg/m2 (1 h i.v. infusion) repeated every 14 days, followed by~     surgery 9-10 weeks after the start of therapy. Patients in group II will receive four cycles~     of adriamycin 60 mg/m2 (15 min i.v.) and cyclophosphamide 600 mg/m2 (1 h i.v.) every three~     weeks, followed by four cycles of docetaxel 100 mg/m2 (1 h i.v.) every three weeks. Surgery~     will be performed during week 25 or 26. Patients in both groups will additionally receive~     oral doses of tamoxifen 20 mg once daily for 5 years, starting on the first day of~     chemotherapy. Surgery will consist of removal of the remaining tumor (breast-conserving~     resection or mastectomy) and axillary dissection (Sentinel node biopsy is allowed if the~     patient is involved in a randomized trial. Radiotherapy is applicated according to standard~     proceedings of participating center. A second randomization for additional versus no~     additional postoperative chemotherapy is recommended in ypN+ disease. Patients with disease~     progression during preoperative therapy, chemotherapy can be stopped and surgery can be~     performed immediately.~   "
211406|NCT00793364|"~     Since it is very difficult to have the real thing (Mediterranean diet) we need to find an~     alternative to reduce cardiovascular disease (CVD) risk in subjects with moderate~     hypercholesterolaemia (a major CVD risk factor) living in western countries. Therefore, this~     proposed study is designed to assess if giving olive oil supplements, with or without stanol~     ester, is equivalent to following a Mediterranean diet. Furthermore, the stanol-olive oil~     combination may prove to be superior to olive oil alone.~   "
211407|NCT00793351|"~     The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity~     allogeneic stem cell transplantation (RIST) with RIC regimen in children with neuroblastoma~     who have failed a prior autologous stem cell transplantation. The investigators will~     investigate the potential of RIC regimen in inducing antitumor response if the present~     protocol will indeed reduce the early TRM and allow for sustained donor chimerism.~   "
211408|NCT00793338|"~     The purpose of the study is to evaluate whether sildenafil helps treat heart failure. Some~     patients with heart failure have high blood pressure in the lungs (referred to as pulmonary~     hypertension). Sildenafil is a medication that is used to treat high blood pressure in the~     lungs and may reduce symptoms of heart failure. Studies have looked at the short-term benefit~     of sildenafil in patients with congestive heart failure, but this study will look at the~     longer-term benefits of 12 weeks of therapy with sildenafil.~   "
211409|NCT00793325|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
211410|NCT00793312|"~     The primary objective is to document the acute and mid-term safety and overall clinical~     performance of the Endeavor(TM) Zotarolimus Eluting Coronary stent system in a real world~     Chinese patient population requiring stent implantation.~      To assess the event rate in patient subgroups with specific clinical indications and/or~     vessel or lesion characteristics.~   "
211411|NCT00793299|"~     In order to gain a greater understanding of the full experience of children with~     life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years~     olds in active treatment for cancer, and instruct them to make video illness narratives over~     the course of 1-3 months. The narratives will be studied as an intervention; each of the~     participants will be administered a measure of physical symptoms (the Memorial Symptom~     Assessment scale 10-18) and a measure of self-esteem (the Rosenberg Self-Esteem Scale). The~     video narratives will also be analyzed for content by theme in order to understand the~     participants' experiences in their own words. Our hypothesis is that these narratives will~     provide insight into the lives of children with cancer, increase their self-esteem, and~     decrease symptom distress, and improve communication between patients and their doctors.~   "
211412|NCT00793286|"~     Repair of inguinal hernia is the most common operation of the general surgeon. In recent~     years, it was recognized that chronic postoperative pain is as important for postoperative~     outcome as recurrent hernia. The incidence of pain or discomfort ranges up to 60% of operated~     patients. Despite the fact that laparoscopic hernia repair has been shown to reduce~     postoperative pain compared to open hernia repair, up to 5% of patients suffer from~     persistent discomfort. During that operation the mesh is either fixed using a stapler or~     tissue adhesive glue. With the current study we compare postoperative pain between patients~     undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or~     tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high~     sensitivity.~   "
211413|NCT00793273|"~     This study is conducted in Europe. The aim of this observational study is to observe the~     efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice~     in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin~     initiation is evaluated.~   "
211414|NCT00793260|"~     Compare two care management support program models on medical costs and utilization.~   "
211417|NCT00793221|"~     Chronic total coronary occlusions (CTO) have an especially high risk of angiographic~     restenosis, and need for new revascularization procedures. Drug-eluting coronary stents (DES)~     have demonstrated to significantly reduce the risk of restenosis and new revascularization~     procedures in comparison with bare-metal stents.~      Most data on the efficacy of DES come from the sirolimus-eluting coronary stent Cypher~     (Cordis corp.), and paclitaxel-eluting coronary stent Taxus (Boston Sci.), and the Cypher~     stent is the only DES that has been randomly tested in CTO. Among second-generation DES,~     everolimus-eluting stent (EES) has shown excellent angiographic and clinical results, but~     this DES has not been studied in unfavourable scenario (such as CTO).~      The aim of the CIBELES trial is to demonstrate the hypothesis that EES are equally effective~     in comparison with sirolimus-eluting stents in the treatment of CTO, in terms of angiographic~     efficacy considered as in-stent late lumen loss.~   "
211418|NCT00793208|"~     The study of the vaccine will proceed in two stages after the method of Simon (102). In the~     first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic~     responses occur, the study will be terminated. If 3 or more responses are observed, the study~     will proceed to the second stage, accruing an additional 22 patients. If the second stage is~     complete and a total of 9 or more immunologic responses are observed among the 37 patients~     treated, the treatment response rate for the vaccine will be considered high enough to~     warrant further study. Conversely, if the evaluation of the vaccine concludes at the first~     stage, or if 8 or fewer total immunologic responses occur after completing the second stage,~     the vaccine will not be considered for further study.~   "
211419|NCT00793195|"~     The aim of this study is to determine the feasibility of conducting a trial to examine the~     efficacy of an ω3FA (Omega-3 fatty acid) containing balanced lipid emulsion in the prevention~     of progression of PNALD in infants with Intestinal Failure/Short Bowel Syndrome (SBS) and~     early liver dysfunction.~   "
211420|NCT00793182|"~     The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in~     subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed~     tomography.~   "
211421|NCT00793169|"~     The primary objective of this study is to (1) determine whether local injection of lidocaine~     used during Mohs surgery will elevate serum lidocaine concentrations to a level that could~     cause systemic symptoms and (2) determine whether sustained high levels of serum lidocaine~     occur after intralesional anesthesia on the face and neck. This study is a cross-sectional~     study of 10 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck~     requiring Mohs micrographic surgery. The study will consist of a brief questionnaire and~     blood draws during their Moh's surgical procedure.~   "
211422|NCT00793156|"~     Primary objective of this multicenter, double-blind, placebo controlled, randomized~     withdrawal study are to determine the effectiveness and safety of orally administered AC-820~     in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated~     with end-stage renal disease and hemodialysis, and perform a population PK analysis.~   "
211423|NCT00793143|"~     Bariatric surgery in the treatment of morbid obesity is associated with long-term weight-loss~     and decreased overall mortality. Long-term results have been reported for laparoscopic~     gastric bypass procedures but the long-term results of laparoscopic sleeve gastrectomy are~     yet unavailable. As sleeve gastrectomy is a rapid and less traumatic procedure with good~     short-term results of weight loss and resolution of comorbidities, the investigators~     initiated a prospective randomized two-center study comparing laparoscopic sleeve gastrectomy~     (LSG)with laparoscopic gastric bypass (LGB) in the treatment of morbid obesity. Study~     hypothesis: As sleeve gastrectomy is less traumatic, easier and faster to perform compared~     with gastric bypass,LSG could become the procedure of choice to treat morbid obesity if the~     long-term results of weight loss and resolution of comorbidities are comparable with~     laparoscopic gastric bypass.~   "
211424|NCT00793130|"~     The aim of the study is to reduce the severity and duration of acute attacks, to prevent the~     recurrence of new acute attacks and to improve patient's quality of life.~      Coltect contains anti inflammatory and antioxidant natural agents (curcumin, green tea and~     selenomethionine) which are associated with a positive effect on inflammatory disease.~      The investigators assume that Coltect represents a tolerable and mild treatment, viable~     alternative to other medical therapies with fewer side effects.~      Coltect is a food supplement that contains active ingredients from herbal sources.~   "
211425|NCT00793117|"~     Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a~     prevalent option to treat this disease.During usage of different techniques of surgery, the~     need for packing after surgery is debatable problem. So to solve this problem this research~     has been designed.~   "
211426|NCT00793104|"~     Determine the ability of the allograft plug for the treatment of a cartilage injury in the~     knee~   "
211427|NCT00793091|"~     The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic~     Solution in improving visual acuity relative to placebo in patients with age-related cataract~   "
211428|NCT00793078|"~     Arterial blood pressure (ABP) is regulated by multiple, interconnected feedback loops~     resulting in a variable and complex time course. According to the decomplexification theory~     of illness, disease is characterised by a loss or impaired function of feedback loops~     resulting in a decreased complexity of the ABP-time course and an impaired adaptability of~     the cardiovascular system.~      Decomplexification of physiologic parameters has been shown to occur in coronary heart~     disease, Parkinson's and Hodgkin's disease, and in subarachnoid hemorrhage, but has not been~     evaluated in sepsis.~      This study is intended to test the hypothesis that complexity of ABP~        -  is lower in cardiac surgery versus non-cardiac surgery septic patients,~        -  decreases as severity of sepsis increases to severe sepsis and septic shock,~        -  is associated with outcome three month after sepsis.~   "
211429|NCT00793065|"~     The investigators will conduct a longitudinal cohort study with concurrent controls. The~     investigators will include all primary care physicians in the Hudson Valley including family~     practitioners, internists, and pediatricians. The purpose of this study is to determine the~     effects of implementing electronic health records (EHRs), pay-for-performance incentives for~     physicians (P4P), and Medical Home redesign on health care quality, cost and patient~     experience in the Hudson Valley.~   "
211430|NCT00793052|"~     The purpose of this study is to determine whether Etodalac, Etoricoxib and Dexamethasone are~     effective for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery~   "
211432|NCT00793013|"~     Traditional modes of ventilation have failed to improve patient survival. Subsequent~     observations that elevated airway pressures observed in traditional forms of ventilation~     resulted in barotrauma and extension of ALI lead to the evolution of low volume cycled~     ventilation as a potentially better ventilatory modality for ARDS. Recent multicenter trials~     by the NIH-ARDS network have confirmed that low volume ventilation increases the number of~     ventilatory free days and improves overall patient survival. While reducing mean airway~     pressure has reduced barotrauma and improved patient survival, it has impaired attempts to~     improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch,~     allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure~     release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive~     airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal~     ventilation occurs between the increase in lung volumes established by the application of~     CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have~     suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration~     of pulmonary mechanics, but there are no studies indicating the potential overall benefit of~     APRV in recovery form ALI/ADRS.~   "
211433|NCT00793000|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     PF-04287881 after a single oral dose in healthy adult volunteers.~   "
211434|NCT00792974|"~     The aim of the study is to develop an interview to ask patients with COPD about their fear of~     death and dying, their needs and wishes at the end-of-life. Afterwards, the patients receive~     a brief psychological intervention to develop coping strategies for chronic illness. Beside~     this a general purpose of this intervention is to improve patients' quality of life.~   "
211435|NCT00792961|"~     The study involves use of a device called an endomicroscope to obtain high resolution images~     of microscopic structures during robot-assisted prostate cancer surgery. This feasibility~     study is largely descriptive, and will use endomicroscopy to document the cellular and~     architectural appearance of tissue during minimally invasive prostate surgery for later~     comparison with features seen upon conventional histopathological examination of biopsies or~     resection specimens.~   "
211436|NCT00792948|"~     This phase II trial is studying the side effects of giving combination chemotherapy together~     with or without donor stem cell transplant and to see how well it works in treating patients~     with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving~     chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the~     growth of cancer cells. It also stops the patient's immune system from rejecting the donor's~     stem cells. The donated stem cells may replace the patient's immune cells and help destroy~     any remaining cancer cells (graft-versus-tumor effect).~   "
211437|NCT00792935|"~     The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants~     taking metformin for type 2 diabetes.~   "
211438|NCT00792922|"~     Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious~     cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the~     eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub~     against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO)~     has endorsed a multi-faceted strategy to combat trachoma, which includes the use of~     antibiotic treatment to reduce the community pool of infection with C. trachomatis. The~     objective of this study is to conduct a randomized, community-based trial in three countries~     (Niger, Tanzania and The Gambia), representing different baseline endemicities, of~     alternative coverages and frequencies of administration of mass antibiotic treatment as well~     as to determine the cost-effectiveness of these different strategies from a program~     perspective.~   "
211439|NCT00792909|"~     The purpose of this study is to assess the immune memory induced by primary and booster~     vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through~     evaluation of the immune responses following vaccination with a booster dose of pneumococcal~     conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses~     following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in~     age-matched unprimed children.~      The study also aims to assess the antibody persistence in the fourth year of life following~     primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first~     year of life.~      The study is also designed to evaluate the immunogenicity in terms of antibody response and~     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse~     events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the~     fourth year of life.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = 00307034)~   "
211440|NCT00792896|"~     Family usually had a lot of burden to tell the truth to patients. The purpose of this study~     is to assess the effect of education materials and family conference for advanced cancer~     patients and family.~   "
211441|NCT00792883|"~     The purpose of this study is to monitor the respiratory, metabolic and nutritional status of~     critically ill pediatric patients undergoing mechanical ventilation and to correlate the~     clinical and physiopathological findings with inflammatory activity measurements in order to~     identify prognostic biomarkers.~   "
211442|NCT00792870|"~     Obesity is a major health problem that has reached epidemic levels. Efforts are needed to~     develop cost-effective public health approaches for weight loss and maintenance. One such~     approach is to develop team-based programs that may motivate people to lose weight and/or~     increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI).~     The purpose of this project is to evaluate the overall effectiveness of SURI and to test if a~     behavioral intervention can enhance the effectiveness of the original program. The current~     trial is investigating whether adding a behavioral intervention delivered online would~     enhance the outcomes of SURI participants.~   "
211443|NCT00792857|"~     This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease~     (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different~     dose strengths. This study will also investigate the levels of CTAP201 in the body over time~     and determine the safety of CTAP201.~   "
211444|NCT00792844|"~     Main research Question: The investigators would like to find out if both the Bio-K~     (lactobacillus acidophilus and lactobacillus casei) drink and capsule are equally effective~     in the prevention of diarrhea associated with antibiotic use.~      Why is this research project important? About 25% of patients who use antibiotics may develop~     diarrhea as a side effect. Symptoms are mild and consist of watery diarrhea and abdominal~     pain. Some patients may develop a more severe form of diarrhea, called clostridium~     difficile-associated diarrhea. Clostridium difficile-associated diarrhea may lead to more~     serious consequences like inflammation of the large bowel and in some cases, death. There are~     some studies that suggest Bio-K drink, a probiotic preparation containing lactobacillus~     acidophilus and lactobacillus casei, decreases the risk of diarrhea from antibiotic use. As a~     result, St. Joseph's Healthcare has recently to use Bio-K routinely to try to reduce risk of~     patients developing diarrhea. No other Hamilton hospitals use Bio-K routinely as there is not~     strong evidence about the effectiveness of Bio-K for the prevention of diarrhea. This study~     will provide more information about Bio-K's effectiveness in the prevention of diarrhea~     associated with antibiotic use as both a capsule and a drink.~   "
211445|NCT00792831|"~     This is an open label, un-controlled, phase II, pilot clinical trial testing ITF2357 in a~     population of CLL patients relapsed after or refractory to conventional chemotherapy or~     relapsed after autologus bone marrow transplantation.~      Patient will receive ITF 2357 orally at the dose of 100 mg x 2/die for three months with~     subsequent dose modifications if requested by the patient's conditions.~      Primary objective: To determine overall response-rate, complete response (CR) or partial~     response (PR) Secondary objectives: To assess the safety and tolerability of ITF2357; to~     assess total rate of responders (complete + partial responders); to determine the 6 months~     progression free survival; to determine the effects of the drug on haematological parameters.~   "
211446|NCT00792818|"~     Osteoarthritis of knee is common degenerative musculoskeletal diseases. Non-steroidal~     antiinflammatory drugs (NSAIDs) are used to decrease pain symptom but someone can not~     tolerate its gastrointestinal adverse effects. In vitro studies showed that curcumin had an~     inhibitory effect on substances playing an important role in inflammatory pathway. The~     mechanisms by which curcumin prevents inflammation are postulated through inhibition of many~     cytokines, for example, lipo-oxygenase, cyclo-oxygenase, and phospholipase. Therefore, if~     curcumin is effective as NSAIDs with less side effects, it can be an alternative treatment~     for those OA knee patients.~   "
211447|NCT00792805|"~     This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or~     over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.~   "
211448|NCT00792792|"~     Tissue transfer flaps are a method of moving tissue from a donor location to a recipient~     location. In the case of a free tissue transfer flaps, the blood vessels to the transferred~     tissues are detached and then re-attached to different arteries and veins at the recipient~     site. The process of reconstructive surgery using tissue transfer flaps is not without~     complications. These complications may include acute arterial or venous occlusion, as well as~     the development of late complications such as fat necrosis and flap atrophy.~   "
211449|NCT00792779|"~     The purpose of this study is to determine if propofol could protect erythrocytes by directly~     scavenging free radicals from the blood current and increasing resistance of their cell~     membranes in patients submitted to gastroplasty.~   "
211450|NCT00792766|"~     This is an open label long term follow up study, open to those subjects who were previously~     enrolled inRAD001 Therapy of Angiomyolipomata in Patients with Tuberous Sclerosis Complex~     and Sporadic Lymphangioleiomyomatosis, CCHMC IRB #2008-0812 and who meet the criteria for~     this long-term follow-up study.~      The hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly~     even cause regression.~   "
211451|NCT00792753|"~     Randomized Study To evaluate the safety and effectiveness of the Elixir Medical DESyne~     Novolimus-Eluting Coronary Stent System with Durable Polymer through the assessment of~     clinical, angiographic and IVUS endpoints as compared to the concurrently enrolled Medtronic~     Zotarolimus-Eluting Coronary Stent System in a randomized, single blind study of up to 200~     male and female patients. In a Continued Access Registry of up to 100 patients receiving the~     DESyne Stent clinical-only endpoints will be evaluated.~      To evaluate the safety and effectiveness of the Elixir Novolimus-Eluting Coronary Stent~     System with bioabsorbable polymer as compared to the Medtronic Endeavor Zotarolimus-Eluting~     Coronary Stent System control through clinical and angiographic endpoints.~   "
211452|NCT00792740|"~     The study will be conducted according to a randomized, double-blind placebo-controlled,~     parallel group design in up to 25 clinical sites in Europe.~      Patients will be randomly assigned to two parallel treatment groups (1:1 randomization ratio)~     receiving either ITF2357, as hard gelatine capsule for oral administration, at the dose of 50~     mg b.i.d. (total daily dose of 100 mg), or matching placebo capsules,. Treatment will be~     administered on an outpatient basis for 8 consecutive weeks, followed by a 4-week follow-up.~     During screening, in the 8-week treatment period and in the 4-week follow-up period, patients~     will attend scheduled visits, with physical and laboratory assessments, in order to monitor~     disease evolution and safety and tolerability of ITF2357.~      The study will be conducted in up to 80 patients of both genders, with established diagnosis~     of CD, who present with ulcerations greater than aphthous ulcers in at least one of the five~     bowel segments investigated endoscopically, from the ileum to the rectum, with endoscopic and~     clinical evidence of moderate-to-severe active disease, not controlled by on-going treatment~     with conventional therapies such as 5-aminosalycylates, steroids or immunosuppressants.~   "
211453|NCT00792727|"~     Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating~     mild to moderate pain caused by various musculoskeletal disorders.~   "
211454|NCT00792714|"~     The general objective of the study is to estimate the systemic pharmacokinetics of mannitol~     after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis~     patients.~   "
211478|NCT00792389|"~     Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas~     (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200~     patients. Outcome measures are postoperative opiate analgesia use, and post operative~     numerical pain scores.~   "
219031|NCT00692029|"~     To assess the relationship between pre-teen/teen height, age, weight, gender, and body~     proportions and shape and size of youth and comfort and safety when operating adult All~     Terrain Vehicles (ATV).~   "
211455|NCT00792701|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after~     surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses.~     In this case, observation may be sufficient.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with cisplatin~     works in treating patients with stage I non-small cell lung cancer that was removed by~     surgery.~   "
211456|NCT00792688|"~     The primary objectives of this study are to evaluate safety and efficacy of topically applied~     Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic~     surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower~     eyelids. The study will observe the effects of the topical agent over the course of 1 month~     following the initial treatment.~   "
211457|NCT00792675|"~     The goal of this study was to evaluate the effect of exercise on the number of swollen and~     tender joints associated with rheumatoid arthritis. It was hypothesized that persons would~     have less inflammation associated with rheumatoid arthritis after a 12 week exercise program~     of treadmill walking and weighlifting. Immune parameters were measured to determine potential~     mechanisms responsible for changes in inflammation with exercise.~   "
211458|NCT00792662|"~     The primary purpose of this study is to determine if the study medication Methylphenidate~     (Ritalin) will improve subject's blood-sugar control by improving their motivation more than~     placebo. The secondary objectives of the study are to determine if daily functioning and~     quality of life improves with methylphenidate treatment.~   "
211459|NCT00792649|"~     Colonoscopy is the accepted gold standard for screening of colorectal cancer. However, small~     and flat neoplastic lesions might be overlooked with standard video endoscopes. The new~     available EPKi system (Pentax, Japan) enables with HD+ imaging resolution above HDTV~     standard. Aim of the study was to test the efficacy of HD+ colonoscopy alone and in~     conjunction with I-Scan (newly developed post processing digital filter)in comparison to~     standard videoendoscopy~   "
211460|NCT00792636|"~     The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen~     sodium combination tablets, tablets containing only sumatriptan, and tablets containing only~     naproxen sodium when these drugs are taken to treat migraine headaches that occur during a~     6-month period.~   "
211461|NCT00792623|"~     This study aims to assess the immunogenicity and safety of varicella vaccination in a~     population of autologous peripheral stem cell/ bone marrow transplantation recipients who~     have reached at least four months post-transplantation.~   "
211462|NCT00792610|"~     At the time of the present study, the necessity for booster vaccinations for the prevention~     of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become~     seronegative for HB markers after complete neonatal HB vaccination was in question. A booster~     vaccination strategy may lead to a significant economic impact on national health care~     resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the~     data to support such analyses are lacking. Because an increased risk of HB infection is~     anticipated when adolescents enter into young adulthood through becoming sexual active,~     breakthrough infections such as fulminant HB might be the main concern instead of the risk of~     chronic HB carriage. To address this issue, this study aimed to measure the booster responses~     after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in~     Taiwan before.~   "
211463|NCT00792597|"~     The purpose of this study is to compare the hemoglobin results obtained with 1) the HemoCue™,~     2) the Masimo SpHb™, and 3) the UCSF Clinical Laboratory. The goal is to determine if these~     three values differ from each other during various levels of blood loss in the clinical care~     of patients for spine revision and hip revision surgery.~   "
211464|NCT00792584|"~     Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams,~     dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of~     treatment, with subsequent attenuation but may not completely resolve even years after~     efavirenz initiation.~      The investigators plan a twelve week, randomized, placebo-controlled, double-blind study. In~     group 1, efavirenz will be replaced with efavirenz placebo plus etravirine, in group 2,~     efavirenz would be continued, and etravirine placebo given in addition. After six weeks,~     patients in group 1 would switch to the regimen of group 2, and vice versa.~      The primary endpoint of the trial will be patient preference. Sleep quality, daytime~     sleepiness, and anxiety will also be investigated.~   "
211465|NCT00792571|"~     This is an open-label extension study for patients who participated in the BPS-MR-PAH-201~     study.~   "
211466|NCT00792558|"~     The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects~     with advanced cancers~   "
211467|NCT00792532|"~     The purpose of this study is to determine the safety and effectiveness of a new procedure for~     placing DBS electrodes, in which the entire surgery is performed within an MRI scanner~     (interventional MRI), with the patient fully asleep (under general anesthesia). The~     standard method for the placement of deep brain stimulators does not use MRI during the~     actual DBS placement. The standard method involves placement of a rigid frame on the~     patient's head, performance of a short MRI scan, transport to the operating room, placement~     of the DBS electrodes in the operating room, and return to the MRI suite for another MR to~     confirm correct electrode placement. In the standard method, the patient must be awake for~     2-4 hours in the operating room to have brain mapping performed, where the brain target is~     confirmed by passing microelectrodes (thin wires) into the brain to record its electrical~     activity. In the standard method, general anesthesia is not required. In this study, the~     surgery is guided entirely by MRI images performed multiple times as the DBS electrode is~     advanced. This eliminates the need for the patient to be awake, and eliminates the need for~     passing microelectrodes into the brain before placing the permanent DBS electrode.~   "
211468|NCT00792519|"~     This study will determine whether a cognitive behavioral intervention that demonstrates~     strong evidence in the U.S. of reducing alcohol use is effective when delivered by~     paraprofessionals in Kenya and compared against a usual care support group.~   "
212131|NCT00783692|"~     The primary purpose of this study was to determine the effect of vedolizumab induction~     treatment on clinical response and remission at 6 weeks and to determine the effect of~     vedolizumab maintenance treatment on clinical remission at 52 weeks.~   "
211469|NCT00792506|"~     This is open label, phase IIa High Pulse Dose Clinical Trial testing ITF2357 (orally~     administration)in adult patients with relapsing/refractory multiple myeloma after at least 2~     previous lines of treatment.~      Patients will receive ITF2357 in accordance with following scheme:~      Weeks 1-6~      Patient #01 will be administered ITF 2357 at 400 mg in one single dose on day 1, 8, 15, 22,~     29 and 36. Safety assessments will be performed twice a week. If no issue (grade >3~     neutropenia or any other grade ≥3 toxicity) emerges at day 15 two further patients (#02 and~     #03) will be enrolled and receive the same dose. If patients #02 and #03 show a favourable~     safety profile at day 15, and in the meantime no safety concerns arise from patient #01, the~     further patients will be enrolled and treated according to the below reported scheme:~        -  8 more patients (#04-11) will receive 400 mg once weekly; safety assessments will be~          performed weekly.~        -  1 patient (#12) will receive 600 mg once weekly; safety assessments will be performed~          twice a week.~      If no safety concern emerges from patient 12 at day 15, two further patients (#13 and #14)~     will be enrolled and treated with 600 mg once weekly. If patients #13 and #14 don't show~     relevant safety concerns (grade >3 neutropenia or any other grade ≥3 toxicity) at day 15, and~     in the meanwhile patient #12 maintains a favourable safety profile, eight further patients~     (#15-22) will be recruited and receive the same treatment regimen.~      If grade >3 neutropenia or any other grade ≥3 toxicity appear at any time during week 1-6,~     the treatment will be permanently discontinued.~      In this phase treatment will be administered on an inpatient basis.~      Weeks 7-12~      For patients still on therapy at day 43 visit, M protein will be quantified and the treatment~     continued or possibly modified as follows on the basis of this parameter:~      Decrease >or= of 25%:~      patients in 400/week group continue 400mg for 6 further weeks patients in 600/week group~     continue 600mg for 6 further weeks~      Stable +or- of 25%:~      patients in 400/week group increase to 600mg and continue for 6 further weeks patients in~     600/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue 600mg for 6~     further weeks~      Increase > of 25%:~      patients in 400/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue~     400mg for 6 further weeks patients in 600/week group failure:out of the study patients in~     600/week group~      Safety assessments will be performed at weekly intervals. In case of grade >3 neutropenia or~     any other grade ≥3 toxicity the treatment will be permanently discontinued.~      In this phase treatment will be administered on an inpatient basis.~      Weeks 13-18~      For patients still on therapy at day 85 (week 13, day 1), the response rate will be~     quantified according to EBMT criteria. In case of response (complete, partial or minimal) or~     stable disease (no change) the treatment will be prolonged until week 18, whereas in case of~     disease progression the patient will leave the study. A new complete efficacy evaluation will~     be performed at day 127 (end of treatment).~      During this phase safety will be assessed at weekly intervals and in case of grade >3~     neutropenia or any other grade ≥3 toxicity the treatment will be permanently discontinued.~      This phase of the study will be conducted on an outpatient basis.~      No dosage modification or temporary discontinuation is admitted~      Primary objective:~      To assess the safety of ITF2357 administered once weekly at high pulse dose in patients with~     relapsing/refractory multiple myeloma.~   "
211470|NCT00792493|"~     The purpose of this study is to evaluate the safety and tolerability of escalating multiple~     doses of ORM-12741 in healthy volunteers~   "
211471|NCT00792480|"~     The purpose of this study is to determine if an organized, consistent program of dietary and~     lifestyle counseling will prevent excessive gestational weight gain.~   "
211472|NCT00792467|"~     This is a single-center, open label, phase II study aimed at testing the activity of multiple~     cycles of ITF2357 followed by Mechlorethamine administered to patients with~     relapsed/refractory Hodgkin's lymphoma.~      Patients will receive a maximum of twelve 3-week cycles of ITF2357 followed by~     Mechlorethamine according to the following schema:~        -  ITF2357, 50 mg every 6 hours, per os, days 1 - 3~        -  Mechlorethamine, 6 mg/sqm, intravenously , day 4~      Study therapy will be administered every 21 days as long as there is no evidence of~     progressive disease or unacceptable adverse events or patient's request to discontinue~     treatment occurs, but in any case for a maximum of 12 cycles.~      Decision regarding the continuation of ITF2357/Mechlorethamine therapy will be made on (i)the~     basis of tumor reassessment following cycles 2, 6, 9, and 12 and (ii) the occurrence of~     toxicity. Tumor response will be evaluated according to the International Working Group~     response criteria HL.~      Treatment will be administrated on an outpatient basis and patients will be followed~     regularly with physical and laboratory tests, as specified in the protocol; in case of~     hospitalisation, the treatment will be continued or interrupted according to the~     Investigators' decision.~      The study will accrue 23 patients evaluable for efficacy and the anticipated duration of the~     study is about 24 months.~   "
211473|NCT00792454|"~     The mortality rate of treated patients with end stage renal disease(ESRD)is 22 deaths~     patient-years at risk in 2006. Incident patients with ESRD are most vulnerable within the~     first 90 days of dialysis, with an annualized mortality rate of 50 deaths/100 patient years.~     The vast majority of these deaths are due to cardiovascular causes. As cardiac rehabilitation~     programs have shown a 20% reduction in one year overall mortality rate post myocardial~     infarction the investigator proposes that a similar type of rehabilitation program will also~     have a benificial effect on morbidity and mortality in patients with chronic kidney~     disease(CKD)and ESRD.The overall goal of this project is to study whether a renal~     rehabilitation program based on guided exercise implemented in patients with stage III and~     stage IV CKD can influence the mortality rate of these patients prior to and during the first~     90 days of dialysis~      Hypothesis:The application of a guided exercise program (renal rehabilitation) instituted in~     patients with stage III or Stage IV CKD will decrease the mortality rate prior to the~     initiation of renal replacement therapy.~      Hypothesis:The application of renal rehabilitation during the late stages of CKD will~     decrease the mortality risk during the first 90 days of renal rehabilitation therapy.~      Hypothesis:A guided exercise program will have an immediate and prolonged effect on activity~     levels, mental health and adaption to chronic illness in patients with advanced CKD.~   "
211474|NCT00792441|"~     Prolong mechanical ventilation cause to respiratory muscle weakness and high risk to weaning~     failure,the investigators hypothesize that~        1. Specific inspiratory muscle training (SIMT) using threshold loaded breathing device~          (BreatheMAX V.1)in patients with ventilator dependence will improve inspiratory muscle~          strength~        2. SIMT will improve lung function in patients with ventilatory dependence.~        3. SIMT will improve weaning success in patients with ventilatory dependence.~   "
211475|NCT00792428|"~     The purpose of this study is to determine whether a non-painful, non-invasive,~     brain-stimulation technique called transcranial direct current stimulation (tDCS) combined~     with traditional physical-occupational therapy (OT) will improve motor function in patients~     with chronic stroke. The aim is to determine the effect of applying real (anodal and/or~     cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on~     both hemispheres - in a dual configuration - to improve motor function in chronic stroke~     patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS~     is applied to the brain's motor region during motor learning. The effects after a single~     session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per~     day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in~     stroke patients have shown that improvements in motor functions can be seen and that effects~     may last for at least 30 minutes. Patients enrolled in this trial will be randomized to~     receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days.~     Assessments will be done about 3 days and 7 days after the end of the experimental treatment~     by investigators who are blinded to the intervention. Patients are also blinded as to whether~     they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor~     regions in combination with PT-OT results in a subsequent improvement in motor function of~     the recovering hand over sham tDCS in combination with PT-OT.~   "
211476|NCT00792415|"~     The purpose of this study is to assess the validity and reliability of an abstinence syndrome~     assessment tool used in pediatric patients with iatrogenic opioid dependence.~   "
211479|NCT00792376|"~     The purpose of this study is to evaluate etoricoxib efficacy in pain control, leg stiffness~     and functional recovery of patients suffering acute Achilles tendinopathy.~      It is hypothesized that etoricoxib (120mg orally/day/7 days) efficacy is not inferior to~     diclofenac (150mg orally /day/7 days) for pain control in subjects suffering acute Achilles~     tendinopathy.~   "
211480|NCT00792363|"~     The purpose of this study is to investigate the effect and the side effect profile of~     irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with~     metastatic colorectal cancer without KRAS mutations.~   "
211481|NCT00792350|"~     In this international non-interventional post-marketing surveillance study we want to~     evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib~     (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the~     tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the~     duration of Sorafenib treatment.~   "
211482|NCT00792337|"~     We hypothesize that simvastatin in combination with ICS might have synergistic~     anti-inflammatory effects on airway inflammation in asthmatic patients~   "
211483|NCT00792324|"~     The purpose of the study is to examine the effect of switching from an antiretroviral~     combination that includes efavirenz (Susitiva®), in individuals experiencing~     efavirenz-related side effects, and replacing this with an investigational HIV medication~     called Etravirine (TMC125).~      The study will primarily investigate the effect of change in medication on your viral load~     (the levels of the HIV virus in your blood), on immunological parameters (CD4 count), on~     other safety parameters (such as cholesterol) your side effects and also on your quality of~     life.~   "
211484|NCT00792311|"~     Low current electrical stimulation test, also called the Tsui test, has been used~     successfully to confirm the catheter location in the epidural space in various patient~     populations. The results of this study will show whether or not doing a Tsui test can predict~     inadequate epidural analgesia early in the course of placing the epidural, so that the~     appropriate measures could be applied immediately upon gathering unfavorable results.~   "
211485|NCT00792298|"~     A cross-over, polysomnography study to test the safety, tolerability and effectiveness of~     different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.~   "
211486|NCT00792285|"~     This large randomized controlled trial is testing the effectiveness of automated telephone~     outreach with speech recognition to improve rates of screening for colorectal cancer. The~     hypothesis is that the intervention improves rates of screening overall and specifically~     rates of colonoscopy.~   "
211487|NCT00792272|"~     Dialysis patient could be more aspirin resistant than the general population based on data~     from chronic kidney disease patients~   "
211488|NCT00792259|"~     The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve~     Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified~     predicate device. In addition, this protocol performs a comparison of the thickness~     measurement results from images collected and analyzed with the Zeiss Stratus OCT to images~     collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer~     for analysis.~   "
211489|NCT00792246|"~     Determine how much voriconazole is absorbed when the product is given by mouth to children~     with extensive graft versus host disease after a stem cell transplantation and determine the~     correct dosing of voriconazole in this population.~      Hypothesis: Children with gastrointestinal graft versus host disease will have decreased~     absorption of oral voriconazole and require higher doses of voriconazole in order to prevent~     or treat fungal infections.~   "
211490|NCT00792233|"~     Polyarticular juvenile idiopathic arthritis (Poly JIA) is a form of juvenile arthritis, which~     is a chronic disease affecting approximately 250,000 people younger than 16 years of age.~     Poly JIA can be treated with anti-tumor necrosis factor (anti-TNF), a type of medication that~     is often effective but also has some toxic side effects and is expensive. Among those with~     poly JIA who are effectively treated with anti-TNF, some can remain healthy off the~     medication, but some begin to feel the effects of their disease again once the medication is~     stopped. This study will attempt to find whether certain tests or signs can predict which~     people with poly JIA can safely stop their anti-TNF medications.~   "
211491|NCT00792220|"~     Stroke, the most common cause of permanent disability, the second most common cause of~     dementia and third most common cause of death, has tremendous socio-economic consequences.~      Currently, systemic thrombolysis with the tissue plasminogen activator represents the only~     causal and approved treatment for acute ischemic stroke. However, the chances to save the~     brain tissue by a thrombolytic therapy exponentially decrease with proceeding time after~     onset of symptoms.~      In most cases, the beginning of the thrombolysis therapy is delayed by a variety of factors,~     like delivery to the hospital, re-examinations and delay of blood analysis or of CT scans.~     Due to this, a thrombolytic therapy is possible only in a minority of the stroke patients~     (2-5 %). The aim of this study is to investigate whether a Mobile Stroke Unit, a rescue car~     with an integrated CT scanner, necessary for essential diagnostics, contributes to a better~     stroke management by saving precious time until a therapeutic decision is made. The trial is~     planned as a monocentric, randomised prospective trial.~   "
211492|NCT00792207|"~     Hypothesis: Overweight subjects using a Virtual Coach will demonstrate improved adherence to~     an exercise regime.~      This study is designed to examine the effect of a computer program called a Virtual Coach~     and find out if it helps people become more active. This program acts as a kind of a personal~     trainer and will give you feedback. All participants in the study will receive an activity~     monitor to wear during the study and a website to use to track activity. Half of the~     participants will also receive the virtual coach software. This software will have to be~     downloaded onto your computer, and we will ask that you check in with the coach using the~     software three times a week for 12 weeks. The group you will be placed in will be selected by~     chance.~   "
211531|NCT00791700|"~     The primary purpose of this study is to determine the pharmacokinetic properties (what the~     body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1~     infected children and adolescents. This study will also determine whether maraviroc is safe~     to use in children and adolescents.~   "
212161|NCT00783302|"~     To assess prognostic value of CCTA examination in subjects who undergo CCTA as part of their~     medical care when compared to a standard of truth, i.e. subject outcomes during each~     follow-up period.~   "
211493|NCT00792194|"~     Life expectancy of patients with cystic fibrosis has improved dramatically the last few~     years. Respiratory complications remain the main contributory factor to the morbidity and~     mortality associated with the disease. Exercise tolerance is reduced as the disease~     progresses, and peak aerobic capacity seems to be linked with survival. Regular physical~     activity has positive benefits, including a better body image, an improvement of pulmonary~     function, of exercise capacity and a possible improvement of quality of life.But because of~     the considerable variability of the subjects, exercise programs should be tailored to~     individual needs, and easy included in their cumbersome treatment routines and professional~     activities. In the cystic fibrosis center of Strasbourg we are able to propose to the~     patients a one-year physical exercise program, partly supervised with coaches, at home.~     Electronically braked cycle ergometer and heart rate monitoring system are at patients~     disposal, for one year, at home. Thus, patients can choose, during the day, the best moment~     to work out .Subjects will be randomised in two groups:1. a control group, where subjects are~     asked to continue their normal daily activities and physiotherapy regime.2. a training group,~     where subjects are asked to exercise three times a week. For the training group, three times~     a week, patients will train for 30 minutes. Heart rate will be continuously monitored and~     send to the medical staff every week-end . A correction of exercise intensity, if needed, is~     weekly proposed to maintain a maximal training efficiency, and coaches can help them, if~     necessary. For the two groups, quality of life will be measured with a disease-specific~     questionnaire (CFQ14+) (Henry, 1998, Quittner, 2000), and a generic questionnaire (SF 36)~     (Gee, 2002) before the program, and after 6 and 12 months. After a one year training program,~     and compared to the control group, we should expected an improvement in aerobic capacity and~     peak oxygen consumption, both associated with improved prognosis in cystic fibrosis. We also~     expected to observe an improvement in quality of life measurement, shorter hospital stays and~     fewer exacerbations. With this kind of program, we also would like to improve the degree of~     adherence in daily life exercise.~   "
211494|NCT00792181|"~     This is an intervention study focusing on both medical and nursing questions. The study is a~     joint project between the Ambulance services at four cities in West Sweden and Knowledge and~     research centre, PreHospen at University of Borås. The aim is to prove the importance of a~     caring relation between a patient and a caregiver in cases when a caregiver treats a patient~     with benzodiazepines (Midazolam). The overall aim is to show that knowledge and skills in~     both caring science and medicine can be applied at the same time in order to relieve pain and~     anxiety in acute myocardial disease.~      The nursing intervention involves a professional development course for caregivers. The~     course is expected to deepen the caregivers' knowledge about the encounter with patients as~     well as cardiovascular treatment.~      Following questions are formulated:~      A. What are the effects regarding relieving pain and anxiety in acute myocardial disease? B.~     What are the effects regarding circulatory influence? C. What are the effects regarding~     patients' experiences of the ambulance services? D. What are the effects regarding number of~     care days in relation to acute myocardial disease? E. What are the effects of patients'~     disease complications?~   "
211495|NCT00792168|"~     Primary: to identify physiologic indicators of venlafaxine treatment response using~     quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically~     associated with response to venlafaxine;~      Secondary: to determine if cordance changes early in the course (i.e., prior to improvement~     in clinical symptoms) of venlafaxine (or another antidepressant if venlafaxine is not~     clinically indicated for a particular patient) are predictive of later clinical response.~   "
211496|NCT00792155|"~     Autosomal dominant polycystic kidney disease (PKD) is the most common inherited kidney~     disease, affecting more than 400,000 people in the U.S. and 5 million people worldwide. PKD~     is the 4th most common cause of kidney failure requiring dialysis and/or transplantation.~     Over half of all PKD patients develop kidney failure by age 60 years, although age of onset~     of kidney disease varies widely, even among members of the same family.~      Despite the fact this is a relatively common problem, relatively few patients have been~     studied for a sufficient period of time to fully understand how patients are affected over~     the course of their lifetime. The reason for creating this repository is to collect~     information about PKD so that the investigators may fully understand its complications,~     including high blood pressure, heart attack, and stroke. This information may also aid in the~     development of improved treatment strategies.~   "
211497|NCT00792142|"~     RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking~     blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and~     dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell~     transplant in patients with multiple myeloma.~      PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with~     thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it~     works in treating patients with stage I-III multiple myeloma.~   "
211498|NCT00792129|"~     This study is being undertaken to compare the clinical outcomes of patients that have~     unilateral posterolateral lumbar interbody fusion using a traditional open approach versus~     the MiLIF procedure based on the MiCOR Precision Bone Allograft, specialized Atavi~     instrumentation, and minimally invasive visualization capabilities.~   "
211499|NCT00792116|"~     Context: Gum chewing has been shown to increase cognitive functioning. With the rise in~     standardized testing of school-age children and the concurrent attempts to improve their~     scores, finding simple and inexpensive methods to bolster performance is needed.~      Objective: To examine the effects of gum chewing on standardized test scores and class grades~     in a group of 8th grade math students.~      Design: Math classes were randomized to a gum chewing (GC) condition that provided students~     with gum during class and testing, or a control condition with no gum (NG) provided during~     class and testing. This study was conducted during the Spring 2008 school semester.~      Setting: A charter school in Houston, TX.~      Participants: All students enrolled in eighth grade math at the charter school were~     approached for recruitment in this study. A total of 108 (94%) students participated.~     Participants were between the ages of 13 and 16.~      Main Outcome Measures: The Texas Assessment of Knowledge and Skills (TAKS), the Woodcock~     Johnson III Tests of Achievement (WJ-III), and math class grades were used to assess any~     differences in academic performance between the GC and NGC conditions. For purposes of this~     study, only the math sections of the WJ-III and TAKS, which are both standardized tests, were~     assessed.~      Our primary hypothesis was that adolescents in a gum chewing (GC) condition would have~     significantly improved standardized test scores and math grades compared to adolescents in a~     non-gum chewing (NG) control condition.~   "
211532|NCT00791687|"~     Premature infants are highly susceptible to oxidative stress because of the immaturity of~     their antioxidant defense system. The use of prenatal glucocorticosteroids administered to~     the mother improves respiratory function and overall outcome. The investigators hypothesize~     that prenatal glucocorticosteroids favor the expression and competence of the antioxidant~     defense system.~   "
211500|NCT00792103|"~     The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed~     by:~        -  Subject self-examination skin irritation scores~        -  Adverse events~        -  Changes in vital signs and ECG parameters~      The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:~        -  Headache pain free at two hours after patch activation for all initial acute migraine~          attacks treated with NP101~        -  Headache pain relief at two hours after patch activation for all initial acute migraine~          attacks treated with NP101~        -  Nausea free at two hours after patch activation for all initial acute migraine attacks~          treated with NP101~        -  Phonophobia free at two hours after patch activation for all initial acute migraine~          attacks treated with NP101~        -  Photophobia free at two hours after patch activation for all initial acute migraine~          attacks treated with NP101~        -  Migraine free at two hours after patch activation for all initial acute migraine attacks~          treated with NP101~      This study will use an open-label design to assess the long term safety of NP101 (sumatriptan~     iontophoretic transdermal patch).~      Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not~     contraindicated) and received treatment (patch activation) with the study patch for a~     qualifying migraine under study NP101-007 will be considered eligible for enrollment into the~     open-label study. Subjects will be expected to remain in the study for up to 12 months.~   "
211501|NCT00792090|"~     Impact of fermented milk in prevention of cow's milk allergy in new born and infants~   "
211502|NCT00792077|"~     The goal of this clinical research study is to learn if treatments to kill cancer cells~     including lenalidomide and/or radiation therapy can help to control symptoms such as sleep~     problems and fatigue in patients with chronic lymphocytic leukemia (CLL) and/or breast~     cancer.~   "
211503|NCT00792064|"~     A systematic evaluation of predictors of health related quality of life (HRQoL) leads to~     multiple level of data analysis. The aim of the herein described observational project is to~     create a transplant patients registry on psychosocial outcomes and to evaluate longitudinally~     predictors of HRQoL after different types of solid organ transplantation in the long-term. A~     sample size of 700 participants consisting of all solid organ types is envisioned. Data will~     be compared with published healthy normative data. Data Evaluation of predictors of HRQoL may~     guide development of tailored interventions to reduce complications and to further improve~     outcomes.~   "
211504|NCT00792051|"~     While immunisation of school-age children against influenza is not recommended in Hong Kong,~     past experience in Japan and elsewhere suggests that immunisation of children may protect the~     wider community through its indirect transmission-limiting impact as well as the direct~     immunologic protection afforded vaccinated children themselves. We aim to assess whether~     vaccinating children against influenza protects vaccinees as well as their household contacts~     from infection.~   "
211505|NCT00792038|"~     OCD patients are assessed before and after treatment using diagnostic tools, rating scales~     neuropsychological assessment and functional and structural MR-scans.~   "
211506|NCT00792025|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying sunitinib to see how well it works as second-line~     therapy in treating patients with locally advanced or metastatic transitional cell cancer.~   "
211507|NCT00792012|"~     The purpose of the study is to find out the highest dose per fraction of hypofractionated~     Intensity-Modulated Radiation Therapy (Hypo-IMRT) that can be safely given with temozolomide~     chemotherapy.~   "
211508|NCT00791999|"~     The objective of this trial is to investigate the efficacy (American College of Rheumatology~     20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with~     MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and~     immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of~     foreign data to the Japanese population.~   "
211509|NCT00791986|"~     The purpose of this study is to determine whether adding load to slow controlled breathing~     training could enhance blood pressure lowering in patients with essential hypertension.~   "
211510|NCT00791973|"~     The purpose of this study is to help us to a better understanding of how nose and eye~     symptoms are related in patients with allergies.~   "
211511|NCT00791960|"~     The purpose of this study will be to determine whether an intravenous dose of dimenhydrinate~     (also known as Gravol), given before the induction of spinal anesthesia, will decrease the~     incidence of intraoperative nausea and vomiting in patients undergoing Cesarean delivery.~      This medication is commonly given during and after the surgery if required, but it is not~     known whether a preventative dose will decrease the overall incidence of these side effects.~   "
211512|NCT00791947|"~     This is a phase II prospective non-randomised clinical trial in newly diagnosed and~     previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell~     lymphoma.~      The treatment schedule will consist of three phases: induction and high-dose consolidation,~     followed by autologous stem cell rescue. There will be two different induction schedules: one~     for patients in the age range 18-60 years and one for patients aged over 60 years.~   "
211513|NCT00791934|"~     Study Design:~      A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety~     and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System~     used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.~   "
211514|NCT00791921|"~     The objectives of this study are to verify the superiority in efficacy (American College of~     Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus~     placebo without coadministration of MTX in active RA patients in whom MTX cannot be~     administrated.~   "
211533|NCT00791674|"~     Lay title: A study of breathing pauses during sleep in patients on long term opiates.~      Sleep apnoea is a term which refers to frequent breathing pauses during sleep. Breathing can~     stop at night due to the upper airway collapsing (Obstructive sleep apnoea)or reduced signals~     from the brain driving breathing (central sleep apnoea). Clinical observation has noticed~     that patients on opiates have an increase in sleep apnoea.~      Hypothesis: This study looks at the relationship of opiates (when used for patients chronic~     pain) and the occurrence of sleep apnoea. It is expected that there will be an increase in~     sleep apnoea (particularly of the central variant) particularly in patients on long term~     opiates.~   "
211515|NCT00791908|"~     The primary objective of this study is to determine whether laser treatments over 6 weeks~     using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are~     effective in patients with cherry angiomas as observed by a physician provider and the~     subject.~      The investigators hypothesize that the two laser treatments will be an effective tool for~     treating cherry angiomas. The investigators aim to compare these modalities to~     electrodessication, as all three modalities are considered the current standard of care.~     Electrodessication can result in atrophic lesions at the site of the treated cherry angiomas.~      In summary, the goal of this project is to compare the non-ablative pulsed dye laser and the~     AuraTM potassium titanyl phosphate (KTP) laser to each other and to the current standard of~     care, electrodessication.~   "
211516|NCT00791895|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving~     blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal~     insulin therapy.~   "
211517|NCT00791882|"~     Objective Primary:~      To evaluate the efficacy of social skills training in reducing negative symptoms in patients~     with refractory schizophrenia, in comparison with control (befriending group).~      Secondary:~      To evaluate changes in social functioning.~      To evaluate the effect of SST in other dimensions of psychopathology: positive symptoms,~     depression and general psychopathology.~      To evaluate the impact of SST in cognition.~      Hypothesis Social skills training is more effective than control group (Befriending) in~     reducing negative symptoms in patients with refractory schizophrenia.~   "
211518|NCT00791869|"~     The aim of the investigators research is to see if variants in a particular gene (named~     CYP2B6) affect how the body metabolizes (breaks down) certain medications, including the drug~     bupropion. Bupropion is widely used in the treatment of depression and for helping people~     quit smoking. Genes are portions of DNA that code for particular proteins in the body. The~     investigators are studying the gene that codes for a protein called CYP2B6. Differences in~     the structure of the gene are called variants and may mean that a person metabolizes a drug~     faster or slower than a person with a different variant.~   "
211519|NCT00791856|"~     This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study~     in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy~     (i.e., estrogen for surgically postmenopausal women or a continuous regimen of estrogen plus~     progestin for naturally postmenopausal women) restricted to approved oral or transdermal~     regimens only, or not on concomitant hormone therapy.~   "
211520|NCT00791843|"~     PP1- The purpose of this study is to determine whether giving more of the hormone produced by~     everyone called growth hormone releasing hormone (GHRH) can improve heart function in~     individuals with congestive heart failure. You must be 50 years old or older, have a~     diagnosis of congestive heart failure, and have a high likelihood of having lower than normal~     growth hormone effect. GHRH is approved by the US FDA for treatment in children with growth~     hormone deficiency because GHRH stimulates Growth Hormone (GH). Its use for treatment of~     congestive heart failure in adults is investigational.~      Growth hormone releasing hormone is a hormone produced in the brain. We will be using~     synthetic hormone made in the laboratory. It is identical to the hormone in the brain.~      Many older people, due to aging have low levels of growth hormone. The aim of this study is~     to find out whether restoring growth hormone levels to the levels found in younger~     individuals and then maintaining those levels for 12 weeks will help strengthen heard muscles~     in older persons with congestive heart failure.~   "
211521|NCT00791830|"~     Angiotensin II receptor blockers (ARB) are known to preserve kidney function among patients~     with kidney diseases and reduced renal function, but not among haemodialysis patients.~      Haemodialysis patients often lose residual renal function after initiating dialysis leading~     to worsened quality of life, increased morbidity and mortality.~      In this study an ARB is investigated in a double blind, randomised, parallel group, placebo~     controlled manner to see, if this ARB can save residual renal function among haemodialysis~     patients. Potential cardiovascular benefits of the treatment are also addressed.~   "
211522|NCT00791817|"~     Half the group will be given a high fat diet and the other half will fast. They will then be~     crossed over.~   "
211523|NCT00791804|"~     To evaluate the safety and efficacy of self-titration to effective analgesia with inhaled~     AeroLEF in patients with moderate/severe acute pain in the post-surgical setting.~   "
211524|NCT00791791|"~     The aim of the present prospective randomized study was to challenge the ability of SSI to~     detect painful stimulation during sevoflurane - remifentanil anesthesia.~   "
211525|NCT00791778|"~     Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced~     Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen~     of chemotherapy.~   "
211526|NCT00791765|"~     The purpose of this study is to determine if etanercept is effective in the treatment of~     scalp involvement in moderate to severe plaque psoriasis.~   "
211527|NCT00791752|"~     The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when~     given as single oral ascending doses to healthy volunters. This will be done by comparing the~     effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution~     and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017~     vs time after dose intake will also be collected. The future indication for AZD4017 is~     planned to be Type 2 Diabetes Mellitus.~   "
211528|NCT00791739|"~     The study has a double purpose: a first phase intends to assess the effectiveness and~     tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in~     the treatment of fibromyalgia; a second phase intends to evaluate if the addition of~     pregabalin to patients who have shown a partial response to trazodone additionally improves~     fibromyalgia symptomatology.~   "
211529|NCT00791726|"~     In uveitic patients with fluorescein angiographically proven macular edema, a fundus related~     microperimetry is performed and results are correlated with foveal thickness as measured with~     optical coherence tomography (OCT).~   "
211530|NCT00791713|"~     The purpose of this study is to evaluate the effects of a CYP2D6 inhibitor, paroxetine, on~     the pharmacokinetics of a single dose of orally administered paliperidone ER and to evaluate~     the safety and tolerability of both treatments in healthy men~   "
211534|NCT00791661|"~     A single rising dose study to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM).~     The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe~     and well tolerated, based on the assessment of clinical and laboratory evaluations and~     adverse experiences, in Japanese participants with T2DM.~   "
211535|NCT00791648|"~     Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg~     atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until~     hospital discharge to test the hypothesis that short-term atorvastatin use decreases:~        1. acute kidney injury following cardiac surgery.~        2. postoperative delirium following cardiac surgery.~      Aim1b: Patients using statins preoperatively will be randomized to atorvastatin 80mg or~     placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative~     statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use~     decreases:~        1. acute kidney injury following cardiac surgery.~        2. postoperative delirium following cardiac surgery.~      Endpoints include glomerular filtration, urine and plasma markers of renal dysfunction,~     markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium,~     dialysis, stroke, myocardial infarction, time to extubation, ICU length of stay, and death.~   "
211536|NCT00791635|"~     The goal of this study is to learn if certain characteristics of gynecological cancer can~     help researchers predict how well a patient recovers from pelvic exenteration surgery.~     Researchers will compare the types of surgery completed and procedures used to find out which~     are most effective and safe. Researchers will also study how the surgery affected your~     quality of life.~   "
211537|NCT00791622|"~     The purpose of this study is to 1) determine whether the effect on QT interval corrected~     (QTcLD) for heart rate using the population specified linear derived method at steady state~     is comparable between 12 mg paliperidone extended-release (ER) once daily and that of 400-mg~     quetiapine administered twice daily, 2) to explore the relationship between the~     pharmacokinetics of paliperidone ER and electrocardiogram (ECG) parameters of interest, 3) to~     explore the cardiovascular safety and tolerability of 18 mg paliperidone ER at steady state,~     and 4) to evaluate the safety and tolerability of all treatments.~   "
211538|NCT00791609|"~     Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI~     device on surgically removed tissue~   "
211539|NCT00791596|"~     This Research study aims to investigate the long term effectiveness of a workstation~     ergonomic intervention for work-related posture and low back pain (LBP) of Video Display~     Terminal (VDT) workers~   "
211540|NCT00791583|"~     1. Baseline performance in maximal barrier precaution technique of Emergency Medicine (EM)~          residents, certified in CVC placement, is poor~        2. Simulation-based training in maximal barrier precaution technique during central venous~          catheter (CVC) placement will improve baseline performance of EM residents~   "
211541|NCT00791570|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 or~     A*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in~     patients with Neovascular Maculopathy, including Age Related Macular Degeneration~   "
211542|NCT00791557|"~     Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease~     (Crohn's or ulcerative colitis) and pyoderma gangrenosum.~      This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2~     weeks initially, then every 1-2 months later in the study.~   "
211543|NCT00791544|"~     The primary objective of the study is to select the dose of AVE1642 to be administered in~     patients with liver carcinoma not eligible for local treatment.~      The secondary objectives of the study are:~        -  To evaluate the safety profile of AVE1642 as single agent and the safety profile of~          combinations with other anti-cancer therapies of interest in liver carcinoma , including~          detection of immunogenicity.~        -  To evaluate pharmacokinetics and pharmacodynamics profiles of AVE1642 as single agent or~          any PK interactions when given in combination with other anti-cancer therapies.~        -  To assess the preliminary clinical activity in terms of response rate (Complete response~          + Partial response), duration of responses, stabilisation rate and duration of~          stabilisation, according to RECIST criteria.~        -  To assess the biological activity at the tumor level.~   "
211544|NCT00791531|"~     Previous investigations indicate that methotrexate, an old anticancer drug, could be used at~     low doses to treat malaria. This is a phase I evaluation to assess the safety and~     pharmacokinetic profile of this drug in healthy adult male Kenyan volunteers.~   "
211545|NCT00791518|"~     A multicenter study to evaluate lung function and symptoms in subjects with COPD who have~     been on regular use of only one long-acting bronchodilator.~   "
211546|NCT00791505|"~     Antibiotic therapy has been shown to be beneficial in patients with severe acute exacerbation~     of chronic obstructive pulmonary disease (COPD). Although recent guidelines support the use~     of new antibiotics there is no evidence that newer antibiotics are any better than older~     agents. The choice of antibiotic to be used in this situation is challenging to the clinician~     who must choose between traditional antibiotics (cyclins, aminopénicillins, cotrimoxazole...)~     and new antimicrobial agents. Indeed, available comparative studies did not show an obvious~     superiority of new antibiotics compared to their predecessors . Taking into account bacterial~     agents associated to COPD exacerbations, one must choose an antibiotic which has the best~     activity against Haemophilus influenzae, Streptococcus pneumoniae and Branhamella~     catarrhalis. News quinolones are represented as an interesting alternative to standard~     antibiotics because of their large spectrum of action and of their pharmacokinetic advantages~     allowing high tissue penetration in the pulmonary parenchyma and tracheobronchial tree. Data~     on their use among patients having moderate exacerbation of COPD are encouraging but their~     effectiveness in more severe presentations is not established. The objective of this~     randomized controlled and double blind study is to evaluate the effectiveness and tolerance~     of ciprofloxacin compared to trimethoprim sulfamethoxazole in patients admitted to ICU for~     severe exacerbation of COPD requiring mechanical ventilation.~   "
211547|NCT00791492|"~     This study is designed to determine the long-term safety and tolerability of Fx-1006A as well~     as the effects of Fx-1006A on clinical outcomes in patients with ATTR-PN.~      All patients who enroll in this extension study will receive once-daily oral 20 mg Fx-1006A~     for 12 months; therefore, patients randomized to placebo in Study Fx-005 will cross over to~     active drug (Fx-1006A 20 mg) during this study. However, patients and their families as well~     as clinical Investigators and their clinical site staff will remain blinded to the original~     Fx-005 treatment assignment. It is intended that there will be no interruption in study~     medication administration between the two studies. The majority of safety and clinical~     outcomes assessments will be identical to those evaluated in Study Fx-005. Additional~     assessments for this open-label extension study include 24-hour Holter monitoring and skin~     biopsy for IENF; patients will be required to provide written informed consent to participate~     in this open-label extension study prior to having these additional procedures performed.~      The values obtained from procedures and evaluations conducted during the Month 18 visit of~     Study Fx-005 will be used as the Baseline values for this open-label extension study. The~     Baseline assessments of IENF and Holter monitoring may be conducted at either day of the~     Month 18 visit days of Study Fx-005, but prior to the first Fx-1006A dose in this open-label~     extension study. Clinic Visits will be conducted at Week 6 (± 2 days), and Month 3 (± 1~     week), Month 6 (± 2 weeks), and Month 12 (± 2 weeks). Monthly telephone contacts (± 1 week of~     the scheduled date) will be made during months in which no investigative site visits are~     scheduled (Months 2, 4, 5, 7, 8, 9, 10, and 11) for assessment of adverse events and~     concomitant medications.~      Neurological evaluation by NIS-LL will be performed at Months 6 and 12. The NIS-LL will be~     assessed by utilizing the average of two successive NIS-LL clinical assessment scores~     obtained at least 24 hours apart within a one week period for each study visit. A dedicated~     neurologist will be required to perform NIS-LL scoring across all time-points for each~     individual patient enrolled in the study.~      Quality of life utilizing the Norfolk QOL-DN will be assessed at Months 6 and 12 (based on~     the total score as well as the five individual domains of the questionnaire).~      QST (utilizing CASE IV), NCS, HRDB, mBMI, and echocardiography will be conducted at Months 6~     and 12. Holter monitoring will be conducted at Baseline and Months 6 and 12. Biopsies for~     IENF will be obtained at Baseline only. Assessments of troponin I and NT-pro-BNP levels will~     be made at each study visit.~      Blood samples for pharmacokinetic assessments (Fx-1006A concentrations as well as calculated~     steady-state parameters) and pharmacodynamic assessments (TTR stabilization) will be~     collected at Week 6 and Months 6 and 12.~      Safety and tolerability will be assessed throughout the study. Vital signs, 12-lead ECG,~     blood and urine samples for clinical laboratory tests (serum chemistry, hematology,~     coagulation panel, urinalysis, and urine pregnancy testing), adverse events, and concomitant~     medications will be assessed at each study visit. Eye examinations (including fundal~     photography) will be conducted at Months 6 and 12. Abbreviated physical examinations will be~     conducted at Week 6, and Months 3 and 6, and a complete physical examination will be~     conducted at Month 12.~      All patients will be contacted by telephone 30 days (± 1 week) after the last dose of study~     medication for assessment of adverse events and concomitant medications.~      Patients who complete the Month 12 visit of this open-label study may be allowed to continue~     receiving Fx-1006A under a compassionate use program.~      Patients who discontinue from the study at any time after enrollment (i.e., early~     termination) will have final safety assessments performed at the time of discontinuation. Any~     patient discontinuing after the Month 6 visit will have all safety and clinical outcomes~     assessments scheduled for the Month 12 visit performed.~   "
211548|NCT00791479|"~     This is a study to demonstrate that different doses of once-weekly LY2189265 injected~     subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in~     participants with type 2 diabetes mellitus.~   "
211549|NCT00791466|"~     Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine~     deficiency on neuromotor development are well established: randomized controlled trials of~     iodine supplements given to iodine deficient mothers before pregnancy or during early~     pregnancy improve motor and cognitive performance of their offspring. However, the potential~     adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear.~     Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in~     iodine deficiency.~      Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant~     women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid~     function, pregnancy outcome, birth weight, infant growth and cognitive performance.~      Study design: Double-blind randomized controlled multicentre trial. Study population:~     Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be~     recruited at two research sites, namely St. Martha's hospital in Bangalore, India and~     Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be~     recruited.~      Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and~     the other half to placebo throughout pregnancy.~      Main study parameters/endpoints: Differences between group means in indicators of thyroid~     function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor~     development.~   "
211550|NCT00791453|"~     This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in~     Medicine will be administered during patients' regular clinic visits. Patients will then be~     referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill~     out a referral form. The form will be given the the CHEC health educator who will assist~     patients in finding literacy-appropriate health information. BMI and Hgb A1c values will be~     compared after 3 months and 6 months to baseline values. It is hypothesized that objective~     assessment of patient use of literacy-appropriate, health information from the Clarksdale~     Diabetes and Metabolism Clinic CHEC will improve Hgb A1c and BMI values among patients.~   "
211551|NCT00791440|"~     This study examines the impact of Cognitive-Behavior Therapy (CBT) on symptoms, physiological~     arousal, stressors, and the ways to deal with them in individuals with schizophrenia and~     related disorders. The primary aim of this study is to investigate the role cognitive coping~     strategies play in mediating the link between stress, physiological arousal, and psychotic~     symptoms in individuals with schizophrenia during recovery from psychosis.~   "
211552|NCT00791427|"~     This is an open-label study assessing electrophysiologic testing of the retina with~     Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related~     macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab~     (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to~     ranibizumab treatment in AMD.~   "
211553|NCT00791401|"~     The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of 3 mg~     extended release paliperidone (ER OROSÃ' paliperidone) in patients with varying degrees of~     renal impairment (mild, moderate, and severe), compared to patients with normal renal~     function. Secondary objectives include the assessing the disposition of the (+) and (-)~     enantiomers by means of an enantioselective liquid chromatography mass spectrometry assay, to~     determine plasma protein binding of the enantiomers in patients with impaired renal function,~     compared with patients with normal renal function, and to evaluate the tolerability and~     safety profile of ER OROS paliperidone in patients with varying degrees of renal impairment~     (mild, moderate, and severe) compared with patients with normal renal function.~   "
211554|NCT00791388|"~     This study is a multiple ascending dose study to Assess the Safety, Tolerability, and~     Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and~     Female Volunteers for 14 Days (27 Doses).~   "
211555|NCT00791375|"~     The goal of this study is to adapt a previously developed web-based physical activity~     intervention so that the intervention targets young adult cancer survivors(age 18 to 39). The~     web-based intervention will then be pilot tested to determine whether it is feasible for and~     acceptable to young adult cancer survivors; we hypothesize that the intervention will be both~     feasible and acceptable. Preliminary data on the effects of the intervention on physical~     activity level, mood and fatigue will also be collected.~   "
211556|NCT00791362|"~     Objective: This study aims to determine the effectiveness and efficiency of a national~     accreditation and improvement programme for general practice, focusing on patients with~     established cardiovascular diseases.~      Design: Cluster randomised trial with a block design. All practices start with the~     accreditation procedure.Intervention group practices are requested to focus their improvement~     plans in the first year on cardiovascular disease. Control group practices are requested to~     focus their improvement plans in the first year on other domains. Measurements at baseline~     are based on the standard audit in the accreditation procedure. Follow-up measurements are~     done 12 months after approval of improvement plans.~      Participants: Primary care physicians in The Netherlands.~      Interventions to be implemented: improvement plans concerning cardiovascular risk management,~     as described by recently updated national multidisciplinary evidence-based NHG / CBO~     guidelines, considering patients with established cardiovascular diseases.~      Implementation strategy: The national programme for accreditation and improvement of general~     practice. This procedure consists of a package of activities, including audit, feedback,~     improvement plans, and follow-up.~      Outcome measures: Primary outcomes are percentages of patients with CVD who have acceptable~     systolic blood pressure and cholesterol levels (quantified according to the indicators in the~     accreditation)and who use aspirin or alternatives. Secondary measures include clinical and~     organisational indicators of quality of cardiovascular care, such as percentages of patients~     with cardiovascular disease whose risk factors were assessed and who received specific~     medication.~      Economic evaluation: Incremental cost effectiveness ratio's are determined of the~     implementation strategy compared to no implementation. The analysis will take a societal~     perspective and a time horizon of the observed period as well as a hypothetical 10 years~     period (using modelling). Uncertainty related to the estimations is examined with sensitivity~     analyses and bootstrapping. The long term economic evaluation is based on Markov modelling.~   "
211557|NCT00791349|"~     The purpose of this study is to assess the cardiovascular safety of paliperidone in patients~     with schizophrenia or schizoaffective disorder, with particular attention to the length of~     the QT/QTc interval, to measure and review other electrocardiogram (ECG) parameters, such as~     QRS and PR intervals, to explore the relationship between the pharmacokinetics of~     paliperidone and ECG parameters of interest, and to explore the safety and tolerability of~     paliperidone~   "
211558|NCT00791336|"~     This study combines nelfinavir (NFV) with radiation therapy and chemotherapy as a treatment~     for non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative~     treatment.~   "
211559|NCT00791323|"~     A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac~     0.04% following peripheral iridotomy~   "
212162|NCT00783289|"~     The primary objective of this study is to evaluate the safety and tolerability of escalating~     multiple SC doses of MEDI-563 in adult subjects with asthma.~   "
211560|NCT00791310|"~     The objective of this pilot study is to estimate a procedure where the biological samples~     routinely obtained at the site of suspected infection could be guided by the early~     realization of a TEP with FDG coupled to scanner X, in patients hospitalized in ICU for~     severe sepsis of unspecified etiology.~   "
211561|NCT00791297|"~     The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring~     delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on:~        1. follicular function and inhibition of ovulation~        2. the endometrium~        3. bleeding patterns; and also to assess safety including effects on the endometrium~   "
211562|NCT00791284|"~     The purpose of this study is 1) to investigate the single-dose pharmacokinetics of immediate~     release (IR) paliperidone, after oral administration, in patients having moderate hepatic~     impairment compared to patients having normal hepatic function, 2) to document the plasma~     protein binding and disposition of the enantiomers of paliperidone, and 3) to evaluate the~     tolerability and safety profile of IR paliperidone in both patient populations.~   "
211563|NCT00791271|"~     The goal of the first phase of this clinical research study is to find the highest tolerable~     dose of decitabine and peginterferon alfa-2b that can be given in combination to patients~     with melanoma. The safety of this drug combination will also be studied.~      The goals of the second phase are to learn if decitabine and peginterferon alfa-2b combined~     can help to control melanoma, and to find out which doses are more effective and/or better~     tolerated.~   "
211564|NCT00791258|"~     The initial 12 week portion of this 20 week study will examine the ability of a combination~     of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high~     blood pressure who have not had sufficient blood pressure reduction using one~     anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine~     the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to~     lower blood pressure in the same patient population. All three medications being tested have~     been approved by the FDA for the treatment of high blood pressure, but only amlodipine and~     olmesartan are currently approved for use in combination form.~   "
211565|NCT00791245|"~     The purpose of this post market study is to evaluate surgical implantation technique and the~     quality of repair of the cartilage defect with particulated juvenile cartilage in the human~     knee joint.~   "
211566|NCT00791232|"~     The purpose of this study is a noninferiority comparison of the orthostatic tolerability of a~     dose of 12 mg extended-release (ER) OROS paliperidone with the current recommended initial~     titration dose (2 mg) of immediate-release (IR) risperidone in patients with schizophrenia.~     Other study objectives are 1) to compare the tolerability and safety of a clinically~     equivalent fixed dose of ER OROS paliperidone with the currently recommended dose of~     risperidone, 2) to compare the early tolerability of the 2 treatments with placebo, 3) to~     compare tolerability of the 2 treatments, using a population pharmacokinetic/pharmacodynamic~     (pop PK/PD) model, to 4) assess the relationship between genetic variability in drug~     metabolizing enzymes and interindividual variability in plasma exposure to paliperidone or~     risperidone within each treatment group.~   "
211567|NCT00791219|"~     The objective of this study is to compare the relative efficacy and safety of~     SUBA™-Itraconazole Capsules (HalcyGen Ltd) to an already marketed oral formulation of~     itraconazole SPORANOX® (itraconazole) capsules (Janssen Pharma) in the treatment of~     onychomycosis of the toenail. Both the test and the reference formulations will also be~     compared to a placebo formulation to test for superiority.~   "
211568|NCT00791206|"~     Previously, the preconditioning signaling pathways have been studied on molecular level or in~     animal model. By using MR spectroscopy and imaging in a dynamic human model of~     preconditioning, we will have a better understanding how mitochondrial and endothelial~     function are affected by preconditioning in-vivo.~   "
211569|NCT00791193|"~     The primary purpose of this study is to evaluate the pharmacokinetics and relative~     bioavailability of paliperidone ER formulations with slow, target, and fast in vitro release~     rates after administration of a single 12 mg dose. The slow and fast releasing ER tablets~     have in vitro release rates outside the current commercial specifications. Therefore, in~     order to support widening of the specification limits, this study will be performed. The~     target formulation to be used is representative of the commercial formulation. Other~     objectives of this study are 1) to compare the relative bioavailability of paliperidone ER~     formulations with slow, target, and fast in vitro release rates to the paliperidone IR~     formulation; 2) to explore the in vitro in vivo correlation (IVIVC) for the paliperidone ER~     formulation; and 3) to evaluate the safety and tolerability of the different paliperidone ER~     formulations.~   "
211570|NCT00791180|"~     The primary purpose of this study is to track and document the clinical outcomes of patients~     with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.~     Secondary purpose of this study is to assess outcomes with historical controls along a~     continuum of motion and anatomy sparing procedures.~   "
211571|NCT00791167|"~     The purposes of this study are to evaluate the dose proportionality of 1.5- and 3 mg tablets~     of paliperidone ER, to document the pharmacokinetics of a 1.5 mg dose of paliperidone ER, and~     to assess the safety and tolerability of the 1.5- and 3 mg tablets in healthy men.~   "
211572|NCT00791154|"~     This trial is titled A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based~     Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC).~      Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to~     identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus~     cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.~      Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm~     investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with~     platinum-based chemotherapy.~   "
211573|NCT00791141|"~     This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of~     post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of the~     head and neck.~   "
211574|NCT00791128|"~     The purpose of this study is to determine whether the GI Sleeve is safe and effective in~     treating Type II diabetes patients~   "
211644|NCT00790192|"~     Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This~     clinical study is designed to test the hypothesis that lurasidone is effective, tolerable,~     and safe as compared with quetiapine XR short term among acutely psychotic patients with~     chronic schizophrenia.~   "
211575|NCT00791115|"~     The purpose of this study is to compare the location of the cancer found in the prostate~     gland after it is removed to the location that was predicted on the MRI scan during biopsy.~     In this way, we can better determine if the Magnetic Resonance Imaging (MRI) was accurate,~     and if the MRI could be safely used to guide other types of treatments such as brachytherapy.~     We also plan to carefully measure how frequently surgery is able to completely remove the~     cancer, as well as the side effects and effectiveness of surgery after radiotherapy. The~     study will be coordinated and closely integrated with a separate concurrent study of~     MRI-guided prostate biopsy, which will be performed prior to accrual to this trial (UHN~     05-0641-C).~   "
211576|NCT00791102|"~     The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and~     can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge~     with antigen.~   "
211577|NCT00791089|"~     To determine if peri-operative treatment with omega-3 fatty acids is associated with a~     decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an~     improvement in probability of long-term maintenance of sinus rhythm after radiofrequency~     catheter ablation for Atrial Fibrillation.~   "
211578|NCT00791076|"~     The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is~     naturally produced by the pancreas and that works to control the amount of glucose that the~     liver makes, will reduce the amount of insulin required for people who must take insulin to~     maintain their normal blood glucose level.~   "
211579|NCT00791063|"~     The purpose of this study is to evaluate the potential of [18F]-ML-10 to serve as a~     non-invasive imaging tool for the early detection of apoptosis in brain metastases in~     response to radiation therapy. Such early detection may improve clinical management of~     patients with brain metastases, as it may help early identification of non-responders, and~     subsequently potentially lead to optimization of radiation dose, early decision on focal~     irradiation of selected, non-responsive lesions, or early referral of the patient to surgery.~     The experimental design of the present study aims to evaluate the potential of non-invasive~     PET examination with [18F]-ML-10, to provide the clinician early in the course of treatment,~     via non-invasive molecular imaging of radiation-induced apoptosis, information on tumor~     responsiveness, that is currently available only several weeks to months after completion of~     the radiotherapy.~   "
211580|NCT00791050|"~     Although data on cardioprotective effects (as profile of troponin I)of perioperative~     maintenance of normothermia during CABGs are already known, little is known about the effects~     of maintaining normothermia on clinical outcomes of patients submitted to coronary surgery.~     Being acute renal failure (ARF) and atrial fibrillation (AF) the two most frequent~     complications of this surgery, this study compare as primary end point the rate of~     postoperative ARF and AF in two group of patients, one actively warmed with Thermowrap and~     the control group receiving standard institutional care.~   "
211581|NCT00791037|"~     This phase I/II trial is studying the side effects of escalating doses of adoptive T cell~     therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior~     the expansion of a person's white blood cells may help the body build an effective immune~     response to kill tumor cells that overexpress human epidermal growth factor receptor 2 (HER2)~   "
211582|NCT00791024|"~     Aim: To examine a new method to perform local anesthesia in order to diminish the~     inconvenience by the procedure in patients before performing intubation or~     oesophagogastroduodenoscopy.~   "
211583|NCT00791011|"~     This is a multi-center, phase 1b study of AMG 655 in combination with bortezomib or~     vorinostat in subjects with relapsed or refractory low grade lymphoma, mantle cell lymphoma,~     diffuse large cell lymphoma, and Hodgkin's disease.~      Part 1 is an open-label, dose-escalation phase (3+3 design) to determine the safety,~     tolerability and maximum tolerated dose of AMG 655 in combination with bortezomib or~     vorinostat. Subjects will be enrolled into one of two arms based on investigator selection~     (either the bortezomib + AMG 655 arm or vorinostat + AMG 655 arm).~      Part 2 of the study is a dose expansion phase that will commence after dose selection of AMG~     655 in combination with bortezomib in Part 1. In Part 2, subjects (n = 20) with mantle cell~     lymphoma will be given AMG 655 in combination with bortezomib. The dose of AMG 655 used in~     combination with bortezomib will be based on safety and pharmacokinetic information obtained~     from Part 1 as well as from ongoing AMG 655 trials.~   "
211584|NCT00790998|"~     This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and~     ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes~     river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1~     ratio) to receive one orally-administered dose of either moxidectin or ivermectin.~   "
211585|NCT00790985|"~     To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of~     the knee.~   "
211586|NCT00790972|"~     This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved~     over-the-counter nasal spray, to eliminate the bacteria in your nose.~   "
211587|NCT00790959|"~     The SASA! Study is a cluster randomized trial of a community mobilization intervention for~     the prevention of HIV and gender based violence. The study is being conducted in Kampala,~     Uganda.~   "
211588|NCT00790946|"~     The purpose of this study is to consider the following points in patients with hypertension~     who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard~     treatment.~        -  Blood pressure control~        -  Changing of adiponectin and plasminogen activator inhibitor-1~        -  Influence metabolizing and cardiac function, etc.~   "
211589|NCT00790933|"~     The purpose of this multicenter, open-label study is to collect data on the occurrence of~     important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.~   "
211590|NCT00790920|"~     The purpose of the study is to determine whether desmoteplase is effective and safe in the~     treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of~     stroke symptoms.~   "
211591|NCT00790907|"~     The purpose of this study is to compare the safety of two different dose regimens of~     unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in~     patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction)~     who have been initially treated with fondaparinux.~   "
224389|NCT00621374|"~     The purpose of this study is to see if treatments that include components of self-hypnosis~     training and cognitive behavioral therapy (CBT) can help decrease pain in people with MS.~   "
211592|NCT00790894|"~     This is a Phase II Randomized, Open Label, Non-comparative Trial (Parallel Assignment and~     Efficacy Study) for patients with HER-2 Negative Metastatic Breast Cancer Previously Treated~     With chemotherapy in the Neo-Adjuvant or Adjuvant Setting.Patients will be randomized to~     receive Ixabepilone either every three weeks, or weekly for three weeks followed by one week~     off. Patients will be treated until consent withdrawal, intolerable toxicity or documented~     disease progression~   "
211593|NCT00790881|"~     Despite the clinical significance of potential interactions between antimalarials and~     antiretrovirals, no drug interaction studies have been published and there is an urgent need~     to address this gap in current knowledge.~      This study aims to assess the drug interaction between the antimalarial~     Artemether/Lumefantrine used for management of uncomplicated malaria and Nevirapine-based~     antiretroviral therapy.~   "
211594|NCT00790868|"~     This is a 5-year double blind, randomized, controlled, trial conducted at three treatment~     sites, aimed at showing the acute and longer-term effects of DCS augmentation of~     exposure-based CBT for panic disorder relative to placebo augmentation. By demonstrating that~     DCS can enhance the results of even a brief treatment strategy, the investigators are seeking~     to validate an approach that fits well with the practice limitations and applications of CBT~     in effectiveness studies.~   "
211595|NCT00790855|"~     The goal of the Phase I part of this clinical research study is to find the highest safe dose~     of bendamustine that can be given to patients with acute myelogenous leukemia (AML), Acute~     lymphoblastic leukemia (ALL), Chronic myelogenous (or myeloid) leukemia (CML) in blastic~     phase, Chronic Myelomonocytic Leukemia (CMML), and myelodysplastic syndromes (MDS).~      The goal of the Phase II part of this clinical research study is to learn if bendamustine can~     help to control AML, ALL and MDS. The safety of this drug will continue to be studied.~   "
211596|NCT00790842|"~     Patients with previously treated multiple myeloma and kidney dysfunction will be treated with~     lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of~     lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe~     and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will~     study how well the the treatment works in patients with previously treated (relapsed or~     refractory) multiple myeloma and kidney dysfunction.~      Biological therapies, such as lenalidomide, may stimulate the immune system in different ways~     and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more~     cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have~     changes in their kidney function.~   "
211597|NCT00790829|"~     The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its~     effect on decreasing pain after surgery is the main purpose of the study.~   "
211598|NCT00790816|"~     This study is designed to provide continued access to lapatinib as monotherapy or as part of~     a combination regimen to cancer subjects who are currently participating in a phase I trial~     that has met its study objectives.~   "
211599|NCT00790803|"~     According to a recent estimate more than 280,000 people in the United States are affected by~     uveitis each year. This report, also estimated that uveitis is the reason for 30,000 new~     cases of blindness/year and up to 10 percent of all cases of blindness. The purpose of this~     trial is to determine the effectiveness of VEGF blockade with intravitreal pegaptanib in~     patients with uveitic CME.~   "
211600|NCT00790790|"~     To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an~     effect on pain levels.~   "
211601|NCT00790777|"~     The purpose of this study is to establish bioequivalence of paliperidone ER tablets~     manufactured at Gurabo as compared to paliperidone ER tablets manufactured at Vacaville,~     administered as a single dose of 12 mg under fasted conditions to healthy male volunteers,~     and to assess the safety and tolerability of both formulations.~   "
211602|NCT00790764|"~     The present investigation will be a Phase II, single center, placebo-controlled, randomized,~     dose escalation, infusion modality (intracoronary vs transendocardial injection using the~     Cordis Biosense NOGASTAR TM Mapping Catheter with the Biosense MYOSTAR TM left ventricular~     injection catheter) transplantation of an autologous (your own stem cells) combination of~     bone marrow-derived stem cells into myocardium for the treatment of severe coronary ischemia.~      The purpose of this research study is to determine if the infusion of a combination of stem~     cells obtained from the bone marrow of the same patient will contribute to the formation of~     new blood vessels in patients with symptomatic severe coronary ischemia(CI).~      In this trial we will determine whether the combination stem cell treatment is safe, feasible~     and results in the development of mature stable and/or collateral vessels and improvement of~     cardiac function.~      Coronary Ischemia (CI) is intractable angina due to severe coronary artery disease which can~     seriously decrease blood flow to the heart.~      CI needs a comprehensive treatment since the condition will not improve on its own. The~     overall goal of the treatment is to increase blood flow to the heart and improve symptoms of~     angina.~      The study hypothesis is based on the concept that the process of formation of new blood~     vessels is complex and requires the participation of several types of stem cells and growth~     factors. The lack of any of these components will produce vessels which are immature and~     unable to provide appropriate blood supply to the heart.~      Patients eligible to participate in this study are those suffering from severe blockages of~     the vessels of the heart and are not candidates for percutaneous revascularization or~     surgical procedures.~   "
211603|NCT00790751|"~     This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to~     placebo in men with mild to severe erectile dysfunction.~   "
211604|NCT00790738|"~     This study evaluates the efficacy of the thyroid hormone T3 for depression in patients with~     bipolar disorder. In this study patients will be randomized to receive T3 or placebo.~   "
211645|NCT00790179|"~     Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective~     postoperative analgesia of the lower extremity following total joint arthroplasty. The~     purpose of this study was to compare these two techniques when used with intravenous~     patient-controlled analgesia and the use of patient-controlled analgesia alone for~     postoperative pain management following unilateral total hip arthroplasty.~   "
211605|NCT00790725|"~     In this study, we want to compare two different kinds of artificial ventilation to see if one~     encourages faster weaning from breathing support and if one provides better sleep quality.~     These artificial ventilation types are:~        1. Pressure support ventilation; the standard ventilation that we use for the patients in~          the Respiratory Acute Care Unit. Pressure support ventilation ventilators use constant~          air pressure to assist patients with their breathing.~        2. Proportional assist ventilation; a newer way of helping people with their breathing. The~          air pressure provided by proportional assist ventilation ventilators varies with the~          size of the breath that a person takes.~   "
211606|NCT00790699|"~     The purpose of this study is to determine whether injecting Symlin and insulin through a~     multiple injection port is safe and effective. This will be measured by HbA1c values taken at~     the beginning of the study and at the final visit.~      The secondary objective of the study is to measure patient satisfaction toward using the~     multiple injection port.~   "
211607|NCT00790686|"~     TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess~     its effectiveness, tolerance and mean durability during a 3 years follow up period.~      Patients usually treated with double J stents will be included. The double J stent will be~     replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this~     procedure, the patients will have medical examinations, blood exams, radiography and renal~     sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the~     ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.~   "
211608|NCT00790673|"~     This trial will test the hypothesis that CF102 can safely and effectively suppress viral load~     in patients with chronic hepatitis C and high circulating levels of virus. The trial will~     monitor the safety of twice-daily oral dosing with CF102 over a 16-week period; will measure~     changes in viral load during therapy; and will measure blood concentrations of CF102 at~     various time points during dosing.~   "
211609|NCT00790660|"~     This study is intended to assess safety and tolerability of ASP1941 compared to placebo in~     adult subjects with type 2 diabetes mellitus~   "
211610|NCT00790647|"~     RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the~     growth of abnormal cells by stopping them from dividing or killing them. Giving~     colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the~     bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal~     antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The~     stem cells are then returned to the patient to replace the blood-forming cells that were~     destroyed by the chemotherapy.~      PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib~     followed by stem cell transplant works in treating patients with primary systemic~     amyloidosis.~   "
211611|NCT00790634|"~     The purpose of this study is to characterize and compare irregularities in dopaminergic~     function in fronto-subcortical circuits, between Parkinson's Disease patients (ON and OFF~     medication) and patients with obsessive-compulsive disorder, by examining performance on~     cognitive tasks involving cognitive flexibility, decision-making, and attentional bias.~   "
211612|NCT00790608|"~     The purpose of the study is to determine if topically applied nitric oxide gas is effective~     in reducing the quantity of bacteria (including MRSA)in a wound.~   "
211613|NCT00790595|"~     Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and~     29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are~     diagnosed. This is a stage in which there is high probability that the cancer has spread~     beyond the prostate gland itself, making it much more difficult to treat. In these cases,~     when surgery is done by itself and the prostate is removed, it is still very likely that some~     cancer that has spread beyond the prostate remains and will get worse. Radiation applied to~     the prostate also does not work well on tumors that have spread beyond the prostate. Even~     surgery and radiation combined have not eliminated the problems caused by prostate cancer~     that has spread into the tissue outside the prostate itself.~      New treatments are needed to deal with prostate cancer at this more serious stage. Study~     doctors believe that it might be possible to shrink the prostate cancer using a new drug~     called SUO11248 or Sunitinib. After the patients take the drug, study doctors believe the~     cancer will shrink back to within the prostate, and they can then surgically remove the~     prostate and all the cancer. Patients on this study also will be given increasing doses of~     Sunitinib to find out how much of the drug can be given safely.~   "
211614|NCT00790582|"~     This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is~     to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the~     progression of the disease. Since there is no placebo in this study, all patients will be~     taking lithium carbonate.~   "
211615|NCT00790569|"~     RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is~     not yet known whether varenicline is more effective than the nicotine patch given together~     with nicotine gum in helping smokers quit smoking.~      PURPOSE: This randomized clinical trial is studying varenicline to see how well it works~     compared with the nicotine patch given together with nicotine gum in helping smokers in a~     methadone treatment program stop smoking.~   "
211616|NCT00790556|"~     A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of~     MK8245.~   "
211617|NCT00790543|"~     The purpose of this study for children with a new diagnosis of Crohn's disease is to identify~     biomarkers found in the blood or stool to help predict which children are at risk of~     developing complications.~   "
211618|NCT00790530|"~     The purpose of this study is to evaluate the effectiveness of automated telephone outreach~     with speech recognition to improve diabetes care.~   "
211619|NCT00790517|"~     The purpose of this study is to examine the effectiveness of a lifestyle intervention~     designed to reduce weight and diabetes risk in a population of individuals with mental~     illness who are also taking antipsychotic medications. We will examine the effectiveness of~     the intervention in~        1. reducing weight and Body Mass Index;~        2. reducing fasting insulin levels and increasing insulin sensitivity; and~        3. reducing total cholesterol and LDL cholesterol.~   "
211620|NCT00790504|"~     This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets~     etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery~     mode, by using transperineal ultrasound. This will be compared with pregnancies with single~     fetuses.~   "
211621|NCT00790491|"~     ABSTRACT Although most primary healthcare practitioners recognize the important relationship~     among nutrition, physical activity and health, few incorporate either dietary or physical~     activity counseling into routine practice. AUGMENT will employ interactive technology to~     support effective patient life-style counseling during routine office visits. AUGMENT~     technology will automate the administration, collection, and analysis of dietary and physical~     activity questionnaires, and it will guide counseling and present intervention resources and~     strategies tailored to the patient's unique needs. Using tablet computers, wireless LANs, and~     inexpensive Internet communications, AUGMENT will have advantages over existing tools: 1.)~     Lower usage costs (minimal office personal required), 2.) Ability to customize the system,~     and 3.) Real-time, comprehensive assessment.~      The AUGMENT system efficiently and relentlessly gathers important healthcare information~     (such as total fat, type of fat consumption; fruit and vegetable consumption; fiber and~     micronutrient intake; and energy output). This means patients are less likely to have their~     preventive needs overlooked by a busy practitioner. The assessment includes questions to~     determine the amount of effort the patient will commit to improved health. This will enable~     the physician to effectively guide the patient via targeted recommendations, obtainable~     goals, and a course of action that is both preventive and prescriptive; and to monitor~     progress. Patients who receive objective assessments of their healthcare practices and~     recommendations based on their own unique health history will be more likely to accept and~     act on the recommendations.~      The specific aims of the study are to: 1) Incorporate key elements of a previously developed~     prototype tool into a dietary and physical activity risk assessment system, 2) Create a~     provider training tool to build proficiency in using AUGMENT for counseling to reduce disease~     risk.~      3) Validate the AUGMENT dietary and physical activity assessments using dietary recalls and~     accelerometer data, 4) Complete a process evaluation of the AUGMENT program by using it in~     interventions managed by six physicians with at least 240 patients, and 5) Survey~     participating providers and patients to assess acceptability of AUGMENT within a clinical~     setting.~   "
211622|NCT00790478|"~     Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in~     the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain,~     fever, and fatigue. Melatonin is a hormone that is associated with sleep and other body~     functions that may be related to health. Melatonin is produced in the pineal gland and, in~     fact, it is produced in even greater amounts in the gut. Melatonin appears to be important in~     gastrointestinal tract physiology and health, and data from cell and animal experiments, and~     some studies in humans, suggest that supplemental melatonin may help ameliorate colitis.~     Given that current treatments for ulcerative colitis are not always effective, and often have~     serious side effects, there is considerable interest in finding alternative treatments for~     this disease. However, experimental data on the ability of melatonin to improve ulcerative~     colitis in humans are lacking. To address this, we plan to conduct a pilot clinical trial (60~     adult male and female participants) that will obtain preliminary data about the effectiveness~     of melatonin supplementation as a treatment for ulcerative colitis in adult men and women~     with the disease.~      The Melatonin and Ulcerative Colitis study funded by a grant from the Broad Foundation's~     Broad Medical Research Program (http://www.broadmedical.org).~   "
211623|NCT00790465|"~     Flavanols, present in dark chocolate, were shown to induce Nitric Oxide synthesis. Since~     Nitric Oxide facilitates smooth muscle relaxation, it might ease the relaxation of the LES~     (lower esophageal sphincter)as well.~      The objective of the present study is to evaluate tha efficacy of dark chocolate in improving~     LES relaxation in achalasia patients.~   "
211624|NCT00790452|"~     Primary objective:~      To determine whether aspirin (ASA) can lower the incidence of Venous Thromboembolism(VTE) in~     patients with Glioblastoma (GBM).~      Secondary objectives:~      To determine clinical and laboratory factors which are associated with increased risk of VTE~      If it is determined that ASA reduces the incidence of VTE in patients with GBM, then to~     determine the clinical and laboratory factors which are associated with an increased benefit~     from the drug.~   "
211625|NCT00790439|"~     Type 1 diabetes mellitus (T1D) is an autoimmune disease in which the insulin-producing~     pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of~     this study is to assess the safety and effectiveness of low molecular weight sulfated dextran~     (LMW-SD) on post-transplant islet function in people with T1D who have responded to intensive~     insulin therapy and have received kidney transplants. This study is taking place in Uppsala~     and Stockholm, Sweden, and Oslo, Norway.~   "
211626|NCT00790426|"~     This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer~   "
211627|NCT00790413|"~     Children with primary resistant or relapsed neuroblastoma who do not achieve remission with~     conventional chemotherapy have extremely dismal prognosis. A novel treatment strategy~     combining tumor targeted radioisotope treatment with metaiodobenzylguanidine (MIBG) and~     immunotherapeutic effect of haploidentical stem cell transplantation (haploSCT) followed by~     low-dose donor lymphocyte infusions will be piloted. The use of the isotope is aimed to~     decrease pre-transplant tumour burden. Reduced intensity conditioning containing Fludarabine,~     Thiotepa and Melfalan will enable sustained engraftment as well as will serve as additional~     anti-tumor treatment. A prompt natural killer (NK)-cell mediated tumour control may be~     achieved by haploidentical stem cell transplantation. The investigators hypothesize that~     tumour cells potentially evading NK-cell mediated immunity may be targeted by infused donor~     T-cells and eliminated by either MHC-dependent manner or through a bystander effect. The~     possible graft versus tumor effect will be evaluated in children with therapy resistant~     neuroblastoma.~   "
211628|NCT00790400|"~     This study will evaluate the safety and efficacy of RAD001 in treating patients with~     Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic~     Lymphangioleiomyomatosis.~   "
211629|NCT00790387|"~     Patients undergoing coronary angioplasty are frequently treated with new drugs that stop~     blood platelets working and so improve the success of the procedure. Individual patients may~     vary in the dose of the drug required. New platelet tests have been developed which can be~     performed near the patient and possibly immediately tell the doctor the degree of platelet~     inhibition achieved so that the dose can be adjusted accordingly. This study aims to~     investigate if these platelet tests indicate if new anticoagulants are more effective at~     inhibiting platelet function than the traditional anticoagulants. The study will demonstrate~     if these newer drugs improve blood flow through the heart muscle and thereby provide better~     long term outcomes for patients undergoing percutaneous intervention.~   "
211630|NCT00790374|"~     The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in~     patients with prostate cancer with disease progression while on androgen ablative therapy~   "
211646|NCT00790166|"~     That the level of humidification delivered to patients during CPAP treatment will alter the~     subjects mucociliary clearance rate and related mucus properties.~   "
211647|NCT00790153|"~     To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656~     suspension.~   "
232835|NCT00508534|"~     This study will examine the effects of altering gastric pH in healthy volunteers on the~     pharmacokinetics of SB-751689 with or without food.~   "
211631|NCT00790361|"~     Traumatic spinal cord injury is a common injury to the spine and can lead to a clinical~     syndrome called central cord syndrome (CCS). CCS is an incomplete spinal cord injury where~     one starts to lose more motor function in the upper rather than lower extremities. It affects~     a wide range of the population from the young to the old. However, the natural history of CCS~     is poorly understood.~      Research has shown that the injury resulting in CCS might be due to the pinching or~     compressing of the spinal cord. This creates damage to a part of the spinal cord and creates~     difficulties in the signal getting through. We believe that we can gain a better~     understanding of the natural history of incomplete spinal cord injury as well as the recovery~     process.~      It is possible to track many changes in the brain and motor function through a variety of~     methods. One can track the concentrations of different chemicals (metabolites) by using~     magnetic resonance spectroscopy (MRS), changes in brain activation by using functional~     magnetic resonance imaging (fMRI) and thread-like nerve fibers in the spine by using~     diffusion tensor imaging (DTI). In our study we will be detecting differences in brain~     metabolism and activation of different parts of the brain during specific movement and in the~     nerve fibers in the brain.~      We hypothesize that there will be decreased levels of N-acetylaspartate (NAA, a putative~     marker of neuronal function) and decreased levels of glutamate (the primary excitatory~     neurotransmitter) in the motor cortex in patients with CCS when compared with controls. Over~     time, we hypothesize that the normalization of metabolite levels will correlate with the~     extent of neurologic recovery. We also hypothesize a reorganization of brain activation~     patterns with time such that patients will show increased volumes of activation in the motor~     cortex with recovery and that this will correlate with the extent of neurologic outcome. Over~     time, we predict that there will be normalization of the fibre track anatomy that will~     correlate with neurological recovery.~   "
211632|NCT00790348|"~     The purpose of this study is to see the effect of Januvia on Ghrelin levels in patients with~     diabetes.~   "
211633|NCT00790335|"~     The purpose of this study is to determine if the use of adjunctive Pharmacomechanical~     Catheter Directed Thrombolysis, which includes the intrathrombus administration of~     rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with~     symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy~     alone.~   "
211634|NCT00790322|"~     The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral~     mucositis in head and neck cancer patients undergoing radiation therapy.~   "
211635|NCT00790309|"~     The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very~     short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical~     Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as~     to compare these changes to diet-induced changes in the same population.~   "
211636|NCT00790296|"~     The primary objective of the study is to evaluate thyrotropin releasing hormone (TRH) as a~     treatment for cancer-related fatigue.~      The central hypothesis of this pilot study is that TRH is more efficacious than placebo in~     alleviating cancer-related fatigue in patients with breast or prostate cancer.~   "
211637|NCT00790283|"~     The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of~     the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native~     coronary arteries and compare it to the VISION/MINIVISION coronary stent~   "
211638|NCT00790270|"~     The purpose of this study is to see whether the combination of a muscle relaxant and~     anti-inflammatory drug is more effective at relieving pain in patients with neck strains or~     whiplash than either of the two medications alone.~   "
211639|NCT00790257|"~     In view to avoid immunosuppression, the investigators are submitting a Phase 1 clinical trial~     protocol testing the safety and the efficacy of encapsulated human islets in a Monolayer~     Cellular Device for allogeneic islets transplantation in Type 1 diabetic patients performed~     at the University clinical hospital Saint-Luc, Brussels. Encapsulated human islets will be~     transplanted in the subcutaneous tissue as safety procedure for patients.~      This protocol (single center trial) is designed as a limited series of islets transplants for~     15 Type 1 diabetic adult subjects.~   "
211640|NCT00790244|"~     SSG XX is a phase II trial for high-risk soft tissue sarcomas (STS) of the extremities and~     trunk wall. Prognostic factors (histopathological markers) are used to identify high-risk~     tumors. SSG XX will evaluate chemo- and radiotherapy given adjuvantly to these patients. In a~     specified group of patients also preoperatively given therapy will be studied.~   "
211641|NCT00790231|"~     Acute urinary retention is one of the most common complications after surgery and anesthesia.~     Overfilling the bladder can stretch and damage the detrusor muscle, leading to atony of the~     bladder. It can occur in patients of both sexes and all age groups and after all types of~     surgical procedures. Micturition depends on coordinated actions between the detrusor muscle~     and the external urethral sphincter. Motorneurons of both muscles are located in the sacral~     spinal cord and coordination between then occurs in the pontine tegmentum of the caudal brain~     stem. Motorneurons innervating the external urethral sphincter are located in the nucleus of~     Onuf, extending from the S1 to the S3 segment. The smooth detrusor muscle is inner-vated by~     parasympathetic fibers, which reside in the sacral intermediolateral cell group and are~     located in S2-4. Sympathetic fibers innervating the bladder and urethra play an important~     role in promoting conti-nence and are located in the intermediolateral cell group of the~     lumbar cord (L1-L4). Most afferent fibers from the bladder enter the sacral cord through the~     pelvic nerve at segments L4-S2 and the majority are thin myelinated or unmyelinated. Because~     peridural anesthesia can be performed at various levels of the spinal cord and with varying~     concentrations of local anesthetic, it is possible to block only a portion of the spinal cord~     (segmental blockade). So it seems logical that peridural analgesia from a Th 2-4 to Th 10-12~     will have no influence on the micturition reflex. Studies on the urodynamic effects of~     various anaesthetic agents are rare. Under the influence of epidural analgesia, patients may~     not feel the urge to urinate, which may result in urinary retention and bladder over~     distension. Spinal and epidural opioid administrations influence the function of the lower~     urinary tract by direct spinal action on the sacral nociceptive neurons and autonomic fibres.~     It is therefore a common practice for bladder catheterisation in the presence of spinal or~     epidural anesthesia. The excessive use of a transurethral catheter is undoubtedly associated~     with significant morbidity such patient discomfort, urinary tract infections, catheter~     entrapment, bladder calculi formation, urethral trauma and stricture. The risk of infection~     with a single catheterization is 1-2% and can rise to 3 to 7 % a day. There has yet been no~     consensus for appropriate catheterisation strategy and urodynamic changes under thoracic~     epidural anesthesia are still unknown. We expect that a better knowledge on the bladder~     function under epidural analgesia could lead to a more restrictive use of perioperative~     transurethral catheters. Our hypothesis is that thoracic epidural analgesia does not~     influence lower urinary tract function in the male and female. Therefore transurethral~     catheterization is not mandatory for all patients with thoracic epidural analgesia.~     Differences in post void residual urine volume and urodynamic examinations before and during~     thoracic epidural analgesia will be analyzed in 16 men and 16 women undergoing open kidney~     surgery/lumbotomy who receive thoracic epidural anesthesia perioperatively.~   "
211642|NCT00790218|"~     This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer.~     Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily~     basis. Treatment will be assessed for adverse effects and for effects on the tumor.~   "
211643|NCT00790205|"~     This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment~     with sitagliptin used as part of usual care compared to usual care without sitagliptin in~     participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV)~     disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.~      Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to~     usual care without sitagliptin with regard to the risk of developing a confirmed event in the~     primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If~     hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care,~     is superior to usual care without sitagliptin with regard to the risk of developing a~     confirmed event in the primary CV composite endpoint.~   "
232836|NCT00508521|"~     Many stroke survivors exhibit persistent upper limb motor deficits and a non-functional upper~     limb. There is some promising information that suggests motor learning (ML) in conjunction~     with functional electrical stimulation (FES; surface FES; nothing implanted; use of a~     commercially available system) of wrist/finger muscles can significantly enhance the~     functional level of the upper limb. There have been promising studies showing that some~     subjects in the chronic phase (greater than 6 months after stroke) responded favorably to~     combination FES and ML (FES ML). In our pilot studies, FES ML for those in the chronic phase~     (>12 months) produced statistically significant functional recovery. FES was applied using a~     commercially available, two-channel FES system, with electrodes applied to the surface of the~     skin (non-invasive). But if upper limb dysfunction is not immediately treated, that is within~     the sub-acute phase (less than 6 months) following stroke, the following problems can~     develop: contractures and other soft tissue changes; chronic pain; and ingrained, abnormal,~     non-functional movement patterns. The more long-standing these symptoms are, the more~     resistant to treatment they become. Therefore, it is important to provide promising~     interventions prior to the onset of chronic symptoms and dysfunction. Those in the sub-acute~     phase after stroke should be provided with FES ML, in order to more completely restore~     function for a greater number of stroke survivors.~      Specific Aims and Hypotheses The goal of this pilot study is to test the feasibility of the~     proposed treatment in the sub acute phase following stroke.~      HYPOTHESIS. FES ML for 3hrs/day, five days/week, for 12 weeks will be feasible to implement~     in the sub-acute phase following stroke (2 -24 weeks).~      Study Design~      a. Specific Procedures This is a pilot study to test the feasibility of using FES ML for~     upper extremity rehabilitation in a sub-acute stroke population. It is a randomized,~     controlled, single-blind design. Subjects will be 2 - 24 weeks after a single stroke. The~     control group will receive standard care for upper limb rehabilitation consisting of passive~     and active exercise, stretching, bracing, and use of adaptive devices. The experimental group~     will receive the experimental intervention in addition to their standard care.~      CONTROL GROUP INTERVENTION. The control group will receive the standard medical care~     prescribed by the primary physician and covered by the subject's health care policy. Standard~     care will include: soft tissue mobilization; assisted motion exercise; active motion~     exercise; resistive exercise; task practice; use of assistive devices; and modality~     applications conventionally prescribed.~      FES ML INTERVENTION. The research treatment duration will be 3hrs/day, five days per week.~     The subjects will be present for a fourth hour each day, which will be used for breaks and~     rest periods that will be interspersed throughout the intervention time. The treatment~     duration is derived from prior work. We will stimulate muscles in a number of configurations~     including: wrist extension and finger extension; wrist extension and finger flexion; and~     wrist extension, finger flexion, and thumb abduction and opposition. Motor learning will~     include the performance of functional task components and full task practice during the use~     of FES. FES will be triggered by the patient, the treating therapist, or it will be~     automatically sequenced by the device according to alternate channel activations, with~     timings pre-set by the treating therapist.~      MEASURES. Data will be collected at weeks 1, 6, 12 (end of treatment), and 6 months after the~     end of treatment.~      Population The subjects will be sub-acute stroke survivors (2-24 weeks after stroke).~   "
211648|NCT00790140|"~     This study aims to examine whether providing tube feeding with a formula enriched with~     omega-3 fats is better than traditional standard tube feeding in terms of preserving~     nutritional status, improving immune function and reducing medical complications following~     major upper Gut cancer surgery.~   "
211649|NCT00790127|"~     The purpose of this study is to evaluate the safety and tolerability of HQK-1001 administered~     daily for 8 weeks in subjects with beta thalassemia intermedia~   "
211650|NCT00790114|"~     To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a~     CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine~     and its paraxanthine [3-desmethyl] metabolite).~   "
211651|NCT00790101|"~     This is a multi-center, randomized, double-blind, double-dummy study designed to compare the~     effects of risedronate, raloxifene, and placebo on BMD, bone turnover markers, and other~     markers of anabolic activity in postmenopausal women who previously received HRT.~   "
211652|NCT00790088|"~     The aim of the project is to document the international routine practice in sensor usage in~     patients treated with sensor-augmented pump therapy and to assess which variables (e.g.~     training of patients, frequency of sensor usage etc) are associated with an improvement in~     clinical outcome(s) from the start of the sensor use to the end of the follow-up period.~   "
211653|NCT00790075|"~     The goal of this study is to demonstrate safety and efficacy of liquid risperidone in~     psychiatrically hospitalized children, ages 4-12, who would be put in seclusion or restraint,~     or given an intramuscular injection of diphenhydramine because of their out-of-control~     behavior if not medicated with risperidone. The first part of the study will: 1) develop~     appropriate oral doses of medication to reduce out of control or agitated behavior~     effectively with the fewest side effects, and 2) develop a rating system to measure the~     children's behavior i.e. level of improvement, sedation, and untoward effects.~   "
211654|NCT00790062|"~     This is a double-blind 3-arm randomized clinical trial to determine whether higher dose~     oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony~     and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the~     uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of~     maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and~     effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not~     known.~   "
211655|NCT00790049|"~     This is a Phase 1 study, involving both 1-day and 8-day dosing periods, designed to test the~     safety of investigational study drug ARRY-371797 in healthy subjects. Approximately 48~     healthy subjects from the US will be enrolled in this study.~   "
211656|NCT00790036|"~     Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell~     Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete~     response with first-line rituximab-chemotherapy~   "
211657|NCT00790023|"~     To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg)~     once daily compared to placebo in subjects with SAR.~   "
211658|NCT00790010|"~     The purpose of this research study is to determine the safety of using the study drugs~     bevacizumab and ipilimumab together, and the doses in combination which can be given to~     people safely. This study also seeks to investigate whether using both study drugs lengthens~     the amount of time before the participants melanoma worsens.~   "
211659|NCT00789997|"~     The purpose of this study is to determine whether treatment with antibiotics plus a TNFalpha~     antagonist will provide more effective treatment for acute COPD exacerbation compared to the~     current standard treatment of antibiotics plus prednisone.~   "
211660|NCT00789984|"~     The purpose of this study is to determine whether some endothelium morphologic variables are~     different between infectious and noninfectious uveitis group using a noncontact specular~     microscopy device.~   "
211661|NCT00789971|"~     Cataract extraction is one of the most common operative procedures performed throughout the~     world. Conventionally, patients are discharged with postoperative drops of steroids and~     antibiotics or a combination of both. These drops are to be administered for 2-6 weeks~     depending on individual eye unit protocol. Many patients find the postoperative drops arduous~     and non-compliance can cause prolonged inflammation and discomfort. Patients with cognitive,~     physical and visual impairments require assistance from family or community nurses to~     administer drops. A single perioperative injection of Triamcinolone has been shown to be an~     effective replacement for drops postoperatively in two previous studies 1, 2.~      Aims & objectives~      The aim of this study is to see if a single orbital floor injection of Triamcinolone is~     equivalent to conventional steroid and antibiotic drops used post operatively in uneventful~     phacoemulsification surgery in treating postoperative inflammation.~   "
211662|NCT00789958|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Specialized radiation therapy that delivers a high dose of radiation directly to the tumor~     may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug~     (combination chemotherapy) together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving capecitabine together with~     gemcitabine followed by capecitabine and radiation therapy works in treating patients with~     cholangiocarcinoma of the gallbladder or bile duct.~   "
211663|NCT00789945|"~     The inclusion of Timing of premeal insulin administration (Timing) in an Intensive Insulin~     Therapy regimen will reduce A1C by an average of 1% in type 1 diabetic patients who have~     initial A1C's between 7.0% and 9.0%.~   "
211664|NCT00789932|"~     This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT)~     program for treating core autism symptoms, social and emotional problems, and adaptive~     behavior deficits in children with autism spectrum disorders.~   "
211774|NCT00788489|"~     The overall goal of this study is to determine how FDG-PET, breast MRI and breast ultrasound~     can be incorporated into the assessment of treatment responses in women with LABC undergoing~     neoadjuvant chemotherapy. A prospective cohort study will be conducted evaluating the ability~     of FDG-PET, breast MRI and breast ultrasound to detect the presence of residual tumour in~     patients with LABC who have completed treatment with neoadjuvant chemotherapy prior to~     mastectomy.~   "
211665|NCT00789919|"~     Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that~     affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases~     exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of~     preeclampsia/eclampsia are a major contributor to maternal death in the world. Delivery stops~     disease progression and recovery can begin. Patients with mild preeclampsia between 34-38~     weeks' gestation usually are hospitalized for evaluation and close monitoring of signs,~     symptoms, and certain laboratory studies as reflectors of disease status. As inpatients~     mothers are monitored frequently for evidence of maternal or fetal compromise until 38 weeks~     gestation when delivery is accomplished. If a patient with mild preeclampsia labors after 34~     weeks, no attempt is made to stop labor and delivery is undertaken. It remains unclear when~     during the third trimester that delivery should be accomplished for maximal maternal safety~     and minimal fetal risk. In this research project, we will identify patients who are at least~     34 weeks pregnant with mild preeclampsia. After informed consent to participate in the trial,~     we will randomize participants to either be delivered immediately or treated with observation~     and maternal-fetal surveillance in hospital as described previously with delivery at 38~     weeks. There will be 110 participants enrolled in each arm of the study for a total of 220~     patients who will be managed in the Wiser Hospital. We intend to analyze a number of maternal~     and fetal outcomes including cost comparisons for the care of both mother and fetus in the~     two groups of randomized patients. The findings should impact care of the pregnant patient~     with mild preeclampsia in the third trimester with regard to how early and how late in~     gestation that delivery should be accomplished for optimal maternal and perinatal benefit.~   "
211666|NCT00789906|"~     Schizophrenia affects cognition, emotion, and behavior. Neuropsychological assessment enables~     a better understanding of antipsychotic effectiveness and the brain processes, underlying~     cognitive functioning in schizophrenia.~      Neurocognitive deficits in schizophrenia patients appears to explain up to 61% of the~     variance of functional outcome and is an important predictor of social reintegration~     (Peuskens et al, 2005) and independent living activitiy (Green et al, 2004). Impaired social~     functioning within schizophrenia population has been associated with increased health-care~     costs. Since social and occupational disability may generate the largest indirect costs of~     the illness, treatment of cognitive deficits has an enormous impact on the cost and~     disability associated with schizophrenia (McGurk and Mueser, 2004).~      However, the gap between cognitive science and clinical practice limits the implementation of~     cognitive assessment in the routine evaluation of schizophrenia patients. Pharmaceutical~     industry initiated numerous large scale, multisite studies on the impact of novel~     antipsychotics on cognitive deficits in schizophrenia patients.~      The aim of this research is to develop population norms of the computerized~     neuropsychological assessment for effectiveness of the antipsychotic treatment in~     schizophrenia.~   "
211667|NCT00789893|"~     Patient will have radiation to treat the cancer. This treatment can make the vagina both~     narrower and shorter. That can cause two problems. It can make it harder for the doctor to do~     a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.~      We tell women to use a vaginal dilator after radiation to the pelvis. This is standard~     education. We do not routinely ask women how they do with it. We are doing this study to see~     if using the dilator as we instruct will help the vagina stretch. The patient will have an~     examine of the vagina before the start of radiation. We will see what size dilator can fit.~     The goal of this study is to have the patient be able to use that size dilator within six~     months after radiation.~   "
211668|NCT00789880|"~     This study will examine whether administration of oral Vitamin D3 given over 21 days will~     change the antimicrobial peptide expression in the skin or saliva of subjects with Atopic~     Dermatitis (AD). This study will help researchers determine if the lack of the expression of~     antimicrobial peptides in individuals with AD plays a role in the susceptibility to eczema~     vaccinatum (EV).~   "
211669|NCT00789867|"~     The study objectives are to assess safety, tolerability and gene expression after a single~     dose of non-viral CFTR gene therapy (pGM169/GL67A) administered to the nose and lungs of~     patients with cystic fibrosis.~   "
211670|NCT00789854|"~     The primary objective of the study is to evaluate the efficacy of Quetiapine extended release~     (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine~     versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine~     versus Quetiapine extended release monotherapy in subjects with treatment resistant~     depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg~     Depression Rating Scale (MADRS) total score. As an independent objective, the primary~     objective will also be evaluated in two subgroups of patients: (1) patients who were~     resistant to two previous antidepressant therapies and (2) in the subgroup of patients with~     one previous failure.~   "
211671|NCT00789841|"~     We will study the total gastrointestinal transit time (GITT), gastric emptying and small~     intestine motility in NET patients before and after treated with somatostatin analogues and~     compare these to healthy subjects. For this we will use radio-opaque markers and the newly~     developed Motility Tracking System (MTS).~      Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying~     and small bowel transit time and an increase in phase III MMC activity compared to healthy~     subjects. Treatment with somatostatin analogues increase transit times and decrease phase III~     MMC activity and improves the clinical symptoms.~   "
211672|NCT00789828|"~     This study evaluated the efficacy and safety of Everolimus in treating patients with~     Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.~   "
211673|NCT00789815|"~     With the advances of flexible bronchoscopy, like metallic stent, electrocautery and real time~     endobronchial ultrasound, the complexity and duration of procedures are increasing. So,~     adequate sedation and analgesia is important for both patients and bronchoscopist.~      Clinical-judged midazolam administration is the current standard. However, midazolam is~     difficult to titrated and the clinical observations are not reliable sedative indices.~     Propofol is titrated easily because of its unique pharmacokinetics. Bispectral index (BIS), a~     real time monitor of depth-of-sedation, has been applied in general anesthesia.~      We design a BIS-guided propofol sedation for bronchoscopy. Through the combination of~     advantages of propofol and BIS, we hope to provide patients a more tolerable and safety~     sedation for bronchoscopy.~   "
211685|NCT00789659|"~     It is the belief of the investigators that the current trends in complication rates~     associated with fixation of pelvic ring injuries and acetabular fractures in the obese are~     unacceptable. The overwhelming majority of these complications can be attributed to problems~     with surgical wound healing. The investigators feel that if a cost effective and easily~     performed intervention can be prospectively utilized in a specific at-risk orthopaedic trauma~     population in order to control a potentially devastating complication, then efforts in~     discovering such an intervention may prove valuable. It is our hypothesis that obese patients~     treated with V.A.C. therapy after standard closure of trauma-related, operative orthopaedic~     incisions will have fewer postoperative wound complications.~   "
211674|NCT00789802|"~     We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the~     number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel~     intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo.~     The objective of this study is to compare the total number of days of bleeding experienced by~     first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to~     those randomized to placebo for the first 12 weeks of use. We will enroll women initiating~     LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will~     enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks~     which will be used to calculate the total number of bleeding or spotting days. Statistical~     analysis will be performed to evaluate if there is less bleeding among the treatment arms~     then the placebo arm.~   "
211675|NCT00789789|"~     This cohort study should provide an exhaustive overview on long-term safety of various~     preventive HIV-vaccines administered in phase I and II clinical trials to healthy volunteers~     of the ANRS network.~   "
211676|NCT00789776|"~     This phase I/II trial studies the side effects and best dose of donor natural killer (NK)~     cell therapy and to see how well it works when given together with fludarabine phosphate,~     cyclophosphamide, total-body irradiation, donor bone marrow transplant, mycophenolate~     mofetil, and tacrolimus in treating patients with hematologic cancer. Giving chemotherapy,~     such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor~     bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Giving an infusion of the donor's T cells~     (donor lymphocyte infusion) may help the patient's immune system see any remaining cancer~     cells as not belonging in the patient's body and destroy them (called graft-versus-tumor~     effect). Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells. Giving mycophenolate mofetil and tacrolimus after the transplant may~     stop this from happening.~   "
211677|NCT00789763|"~     Phase I: Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR)~     of Sorafenib in combination with Gemcitabine and Radiotherapy~      Phase II: Activity profile evaluating Progression-free rates (PFR) at 6 months, Response~     rate, Overall survival, Toxicity profile~   "
211678|NCT00789750|"~     The current study investigates colesevelam as add-on therapy to pioglitazone to improve~     glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with~     pioglitazone monotherapy or pioglitazone in combination with either metformin or a~     sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type~     2 diabetes mellitus will be safe, well tolerated, and efficacious.~   "
211679|NCT00789737|"~     The current study investigates Welchol as monotherapy to improve glycemic control in subjects~     with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The~     study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well~     tolerated and efficacious.~   "
211680|NCT00789724|"~     Thousands of patients die daily from early and late complications of a heart attack (acute~     myocardial infarction, AMI). Patients surviving AMI remain at high risk of death from adverse~     cardiac remodeling (dysfunction and enlargement of the heart) leading to heart failure~     (weakening of the heart).~      Current interventions proven to reduce adverse remodeling and progression to heart failure~     include early reperfusion (restoring blood flow to the heart muscle) and long-term use of~     medicines that block the effects of hormones (such as angiotensin II, norepinephrine and~     aldosterone) involved in adverse remodeling. Despite these treatments, however, many patients~     continue to develop heart failure within 1 year of AMI. These patients are at very high risk~     of death.~      Numerous changes occur in the hearts of patients after AMI that lead to adverse remodeling.~     Ischemia (lack of oxygen) and infarction (cell damage) lead to increased interleukin-1 (IL-1)~     production in the heart. IL-1 plays a critical role in adverse cardiac remodeling by~     coordinating the inflammatory pathway (leading to wound healing) and apoptotic pathway~     (leading to cell death).~      In opposition to IL-1 activity, the human body produces a natural IL-1 receptor antagonist~     that blocks the effects of IL-1. The drug form of this IL-1 receptor antagonist (anakinra) is~     currently FDA approved for the treatment of rheumatoid arthritis, an inflammatory disease~     characterized by excessive IL-1 activity. Experimental studies show that anakinra is able to~     prevent cardiac remodeling and improve survival in mice after AMI.~      We hypothesize that anakinra will show similar benefits in human patients by preventing~     adverse remodeling and heart failure after AMI.~   "
211681|NCT00789711|"~     This study is conducted in Asia. The aim of this observational study is to compare the~     clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of~     diabetes in the Philippines.~   "
211682|NCT00789698|"~     Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This~     clinical study is designed to test the hypothesis that lurasidone is effective, tolerable,~     and safe as compared with quetiapine XR long term among schizophrenic outpatients with~     chronic schizophrenia.~   "
211683|NCT00789685|"~     The purpose of this study was to assess the safety, tolerability and preliminary efficacy of~     FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory~     Distress Syndrome (ARDS).~   "
211684|NCT00789672|"~     This pilot study is being conducted as a prelude to a randomized trial to compare~     levodopa/carbidopa plus patching versus patching alone. The purpose of the pilot study is to~     demonstrate recruitment potential, to provide prospective data on the tolerability of~     levodopa as a treatment for amblyopia, to provide limited data on its safety, to provide~     limited data on it's efficiency, and to provide data to assist in selecting a dose to use in~     a subsequent phase 3 randomized trial. In addition, this study will provide the opportunity~     for investigators to gain experience in using levodopa prior to a randomized trial.~   "
211686|NCT00789646|"~     The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due~     to subconjunctival antibiotic and antifungal injection.~   "
211687|NCT00789633|"~     The objective of this study is to compare the efficacy and safety of masitinib in combination~     with gemcitabine to placebo in combination with gemcitabine in patients with~     advanced/metastatic pancreatic cancer.~   "
211688|NCT00789620|"~     Effective perioperative analgesia is the key to postoperative rehabilitation. An intriguing~     body of evidence suggests that short-term administration of intravenous lidocaine may produce~     pain relief that far exceeds both the duration of infusion and the half-life of the drug.~     When pain relief is provided, concomitant anal-gesic medication can be reduced, side effects~     from pain relieving medication minimized with a potential for a more rapid postoperative~     recovery and less complications. IV application of lidocaine should de-crease the duration of~     bowel dysfunction. We hypothesise that i.v. application of lidocaine in a standard~     antiarrythmic dose can significantly improve acute rehabilitation after laparoscopic~     urological surgery and so shorten the hospital stay (primary outcome). We expect that the~     intraoperative inflammatory response can significantly be reduced.~   "
211689|NCT00789607|"~     This purpose of this study is designed to compare two types of images; magnetic resonance~     imaging (MRI) and Trans-Rectal Ultrasound (TRUS) to see which one performs more accurately~     for the image-guided insertion of Fiducial Markers(FMs) within the tumour. Though effective~     for guiding FM placement at the poles of the prostate gland due to excellent visualization of~     the prostatic boundaries, TRUS may not be ideally suited for marking the GTV. Conventional~     TRUS is neither sufficiently sensitive nor specific for accurate visualization of~     intra-prostatic tumor. A new interventional MRI technique enables needle guidance to the~     gross tumour Volume (GTV) for FM placement. It is of particular importance that both~     techniques be evaluated to enable which one is more effective so that it can be implemented~     in the designs of future trials involving dose-escalation to prostate.~   "
211690|NCT00789594|"~     The investigators propose a cluster-randomized controlled trial (RCT) of computerized~     point-of-care alerts in the EHR to prevent errors related to laboratory monitoring at the~     initiation and continuation of drug therapy and a results management system to prevent errors~     related to the delay in follow-up of abnormal laboratory testing.~   "
211691|NCT00789581|"~     This is a randomized, Phase III, open-label, multicenter study.~   "
211692|NCT00789568|"~     Sapropterin dihydrochloride (subsequently referred to as sapropterin) (Kuvan®) was approved~     by the FDA for the treatment of hyperphenylalaninemia in 2007. Preclinical and clinical~     studies and post-marketing surveillance have not demonstrated any specific cardiovascular~     concerns with sapropterin (Kuvan®). Nonetheless, nonantiarrhythmic drugs may have the~     potential to prolong QT interval, leading to potentially fatal ventricular tachycardias,~     including torsades de pointes. As part of the post-marketing commitment, a thorough QT/QTc~     study will be conducted according to ICH guidelines.~   "
211693|NCT00789555|"~     The purpose of this study was to assess local nasal adverse effects, as well as systemic~     effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase~     Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).~   "
211694|NCT00789542|"~     Strokes occur when blood flow to part of the brain is interrupted. Patients are often~     bedbound for several days or weeks although if they survive, most will make some recovery.~     The lack of mobility encourages blood clots to form in the legs − so called deep venous~     thrombosis or DVT. About 10% of patients will develop these. Pieces of this clot may break~     off and can be carried by the bloodstream to the lungs. These clots, called pulmonary emboli,~     can stop the heart and can cause patients with stroke to die suddenly. A treatment which~     reduces the risk of DVT after surgery is intermittent pneumatic compression (IPC). Inflatable~     sleeves wrapped around the legs inflate at intervals squeezing blood up the legs, increasing~     the blood flow, and decreasing the likelihood of clots forming − at least that is the~     theory!. Although this sounds uncomfortable, most people actually quite like the sensation!~     There have been some small randomised trials of IPC in stroke patients, particularly those~     with intracerebral bleeding. However, these studies although encouraging have not provided~     enough information to persuade clinicians to use this treatment routinely in stroke units.~     The proposed study will include 2000 patients who have had a stroke and who have been~     admitted to a stroke unit.~      Patients who cannot walk independently, and who are at greatest risk of DVT will be invited~     to join the study. If they agree they will be randomly allocated to having routine care plus~     IPC or just routine care. Patient in both groups will have routine ultrasound scans on their~     legs to detect DVTs. The study will establish whether IPC reduces the risk of DVT. This~     result could improve the outcome of many thousands of patients each year.~   "
211695|NCT00789529|"~     The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when~     cared with two different multi-purpose solutions over a two week wearing period.~   "
211696|NCT00789516|"~     Hypercoagulable state is well recognized in patients with β-thalassemia. Evidences of~     hypercoagulability include abnormal expression of phosphatidylserine on red blood cell (rbc)~     surface and consequent increased platelet activation and thrombin generation. In addition, a~     reduction of anticoagulants i.e. proteins C and S and antithrombin (AT) was demonstrated.~     However, coagulable state in patients with β-thalassemia following stem cell transplantation~     (SCT) has not been characterized.~   "
211697|NCT00789503|"~     Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L~     lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of~     vitamin D3.~      Objective: We wanted to characterize the safety and efficacy of fortifying bread with a~     biologically meaningful amount of vitamin D3.~   "
211698|NCT00789490|"~     Deficiencies of iron and folic acid during pregnancy can lead to adverse outcomes for the~     fetus, thus supplements are recommended. Adherence to current tablet-based supplements is~     documented to be poor. Recently a powdered form of micronutrients has been developed which~     may decrease side-effects and thus improve adherence. However, before testing the efficacy of~     the supplement as an alternate choice for supplementation during pregnancy, the~     bioavailability of the iron needs to be determined. The objective of this study is to measure~     the relative bioavailability of iron and folic acid from a powdered supplement that can be~     sprinkled on semi-solid foods or beverages versus a traditional tablet supplement in pregnant~     women.~   "
211699|NCT00789477|"~     This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of~     Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular~     edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and~     EU.~   "
225724|NCT00603447|"~     To evaluate the safety and maximum tolerated dose (MTD) of carfilzomib in combination with~     lenalidomide and dexamethasone in patients with relapsed multiple myeloma~   "
211700|NCT00789464|"~     Probiotics are dietary supplements containing potentially beneficial bacterial strains such~     as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in~     hundreds of studies using adults over the last 30 years. Very few studies have been conducted~     with children. UTI in girls occur when virulent bacteria migrate from the rectum and colonize~     the vagina and peri-urethral mucosa, thus gaining access to the bladder.~      This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics +~     placebo) to determine if UTIs are decreased when the probiotics are given.~   "
211701|NCT00789451|"~     Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the~     heart. Current treatments are designed at relieving this blockage as quickly as possible to~     minimise damage to the heart muscle. However in restoring the supply of blood local damage~     known as ischaemia-reperfusion injury may occur. The aim of this study is to assess how~     clot forming and clot dissolving pathways are affected during this process, and examine the~     role of a natural inflammatory hormone, bradykinin. This will help us to understand the~     mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for~     heart attacks.~   "
211702|NCT00789438|"~     The Surgical Pleth index (SPI) has been introduced as a non invasive tool to measure stress~     and pain during surgery. Preliminary studies were performed in patients under general~     anaesthesia with propofol and remifentanil. These trials showed a good correlation between~     SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage.~     Hence, it was concluded that SPI may be a bedside tool to measure `pain` during surgery. So~     far, no study investigated SPI during regional anaesthesia.~   "
211703|NCT00789425|"~     The purpose of this study is to determine whether the intake of a daily dosage of~     standardized olive extract provides any protection against bone loss.~   "
211704|NCT00789412|"~     The hypothesis of the study is: Does the Surgical Stress Index (SSI) correlate with the~     Behavioral Pain Scale (BPS), the Ramsay Sedation Scale (RSS)and/or the Behavioral Pain~     Scale(BPV) and can therefore be used to monitor the quality of analgosedation in~     noncommunicative intensive care unit patients?~   "
211705|NCT00789399|"~     This trial is a prospective, single-center Phase II randomized study to demonstrate the~     superior efficacy of Fondaparinux Sodium subcutaneous injections in patients undergoing CABG~     surgery (isolated and redo isolated) versus treatment with placebo. All consecutive patients~     scheduled for CABG surgery that meet the general inclusion and none of the exclusion criteria~     will be considered for enrollment in the study.~      Consecutive patients will be randomized on the day of admission prior to their CABG surgery~     into one of two groups. One group will be randomized to the placebo while the second group~     will receive 2.5 mg Fondaparinux Sodium injections. Both groups will receive routine~     mechanical prophylaxis as determined by the treating physicians. Group randomized to receive~     Fondaparinux Sodium will receive a 2.5 mg SQ daily drug dose starting 12 +/- 2 hours~     post-wound closure or the following day in the morning (at the discretion of the~     cardiothoracic surgeon). The second dose would be administered 24 hours later and the dosing~     will then be once a day. The group randomized to placebo will receive subcutaneous equivolume~     isotonic saline at the same time points described above.~      Patients randomized will receive a 2.5 mg dose of Fondaparinux Sodium or placebo~     subcutaneously for a total of 3-9 days post CABG with day 1 being the day of surgery. The~     drug will be discontinued if the patient is discharged before day 9. If the patient stays for~     more than 9 days inside hospital, a duplex would be obtained per protocol and further DVT~     prevention measures would be instituted per the discretion of treating physician.~      Patients will be assessed daily while hospitalized for any symptoms and adverse reactions and~     will undergo laboratory testing (CBC, PT/INR, PTT and UA) as specified in the protocol.~     Post-op day 3-9(no later than 2 days after the last preventive drug dose) patients will~     undergo the protocol specific lower limb venous duplex scan and earlier if symptomatic.~     Patients will also be contacted (phone/office visit) for follow-up 25-35 days post CABG to~     assess for signs or symptoms of deep venous thrombosis or thromboembolism and for any~     potential complications.~   "
211706|NCT00789386|"~     Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and~     leads to deterioration of quality of life. An injury or wound can lead to long term changes~     in the nervous system that make the skin more sensitive at and near the injury; this is~     termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the~     synaptic interaction between neurons.~      Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in~     animal studies the investigators have discovered previously unrecognized effects of opioids.~      Intradermal injection of capsaicin (injection of pepper extract into the skin) is an~     established pain model in humans. The investigators want to test the influence of~     remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal~     capsaicin in human volunteers in a double blind cross-over prospective active placebo~     controlled clinical trial.~   "
211707|NCT00789373|"~     This study will compare progression-free survival in patients with advanced non-squamous~     non-small cell lung cancer. Patients who do not progress following 4 cycles of induction~     treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance~     pemetrexed or placebo.~   "
211708|NCT00789360|"~     The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato~     Loxapine within a day.~   "
211709|NCT00789347|"~     The purpose of this study is to determine whether patients with neuropathic pain has abnormal~     excitability in somatosensory cortex and abnormal sensory-motor connections.~   "
211710|NCT00789321|"~     This study will evaluate methodologies for measuring pedal edema associated with calcium~     channel blockers in middle-aged and elderly subjects and patients with hypertension.~   "
211711|NCT00789308|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells~     are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess~     the safety and effectiveness of low molecular weight sulfated dextran (LMW-SD) on~     post-transplant islet function in people with type 1 diabetes who have responded to intensive~     insulin therapy.~   "
211712|NCT00789295|"~     The aim of this intervention study was to evaluate in type 2 diabetic patients the effects on~     postprandial lipemia and other metabolic parameters (in both everyday life conditions and~     after a standard test meal) of two diets, one moderately rich in CHO, rich in fibre and with~     a low glycemic index (Mediterranean diet), and the other low in CHO and rich in MUFA (Low-CHO~     diet).Since adipose tissue, mainly through its lipolytic activities, is considered as having~     a pivotal role in the regulation of postprandial lipid metabolism, a further aim of our study~     was to clarify the role of adipose tissue in modulating the postprandial lipid response~     induced by the two dietary approaches by evaluating the activities of lipoprotein lipase~     (LPL) and hormone-sensitive lipase (HSL).~   "
211713|NCT00789282|"~     The purpose of the study is to determine the efficacy of a family physician practice-based~     model of chronic disease management (CDM) based in Primary Care Networks (PCN's) that is~     integrated with the Capital Health Regional Diabetes Program for care of patients with type 2~     Diabetes Mellitus.~   "
211716|NCT00789243|"~     Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the~     heart. Current treatments are designed at relieving this blockage as quickly as possible to~     minimise damage to the heart muscle. However in restoring the supply of blood local damage~     known as ischaemia-reperfusion injury may occur. The aim of this study is to assess how~     clot forming and clot dissolving pathways are affected during this process, and examine the~     role of a natural inflammatory hormone, bradykinin. This will help us to understand the~     mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for~     heart attacks.~   "
211717|NCT00789230|"~     The purpose of the present study is to investigate whether or not the use of mesh is~     indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence.~     This method is regularly used in umbilical hernia reconstruction although most surgeons~     repair small hernias using suture repair (fascia adaptation). Especially risk factors for~     hernia recurrence such as hernia size and BMI > 30 kg/m2 need to be evaluated and correlated~     to the method of hernia repair.~   "
211718|NCT00789217|"~     This study aims to compare the readings of skin testing results in patients with suspected~     penicillin allergy between in-house penicillin test preparation and commercial available~     penicillin testing kit.~   "
211719|NCT00789204|"~     The Global Postural Re-Education is a global approach for the treatment of musculoskeletal~     disease. Using specific progressive posture for stretching particular shortened chain muscle~     the method wants to equilibrate the never-ending war between static and dynamic muscles by~     guiding the patient in a particular breathing pattern to maintain a correct posture and~     feeling it.~   "
211720|NCT00789191|"~     This trial is conducted in Asia, Europe and North America. This trial aims for comparison of~     the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue~     with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.~   "
211721|NCT00789178|"~     Patients suffering from Fibromyalgia will be examined for the presence of memory and/or~     cognitive impairment using specific psychological tests.~      Their results will be compared to those with active RA associated with pain and with a normal~     control group.~   "
211722|NCT00789165|"~     The purpose of this study is to determine if quinidine therapy (not guided by the results of~     electrophysiologic studies) will reduce the long-term risk of arrhythmic events in~     asymptomatic Brugada Syndrome.~   "
211723|NCT00789152|"~     This was a study to measure the ability of desloratadine and levocetirizine to decrease nasal~     obstruction in subjects who had study-induced allergic rhinitis. Study participants had~     allergic rhinitis symptoms induced in a Vienna Challenge Chamber and then received~     desloratadine or levocetirizine for 8 days. After at least a 10 to 35-day washout period~     (time when no drug is given), subjects received the opposite treatment for 8 days. Subjects~     had their total nasal symptom measured.on the 8th day of each treatment period.~   "
211724|NCT00789139|"~     Post Marketing study, Interventional, Prospective, non randomised~      Describe how the MD is using the information of the ICM in addition of standard FU(clinical~     exam and holter 24h)post AF ablation(1 year FU).~   "
211725|NCT00789126|"~     Study to evaluate the safety and tolerability of single ascending doses and multiple~     ascending doses of VX-509 administered to healthy male and female subjects~   "
211726|NCT00789113|"~     People over 65 years of ag break down (metabolize) drugs differently than younger adults. It~     is not known why this happens or how elderly people absorb or break down these drug~     differently. These difference may show that elderly individuals need lower doses of~     medications to avoid possible toxicity. We are interested in studying how yor body absorbs~     and breaks down your lamotrigine medication. This research may indicate that doses of~     lamotrigine should be lowered as people get older.~   "
211727|NCT00789100|"~     Nottingham Primary Care Trust has launched telemonitoring to support: independent living and~     self-management ability of people with congestive heart failure (CHF), chronic obstructive~     pulmonary disease (COPD) and co-morbidities; and reduce the health care utilisation~     associated with these patients, including the number of hospitalisations, GP visits and~     community matron and specialist community nurse home visits.~      The Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) will evaluate~     the technology and its impact of this telemonitoring system on quality of care (i.e. process~     measures), patient outcomes and direct healthcare costs from an NHS perspective.~   "
211728|NCT00789087|"~     The purpose of this study is to analyze and compare radiological lung expansion after talc~     pleurodesis performed either by videothoracoscopy or chest tube and correlate it with~     clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of~     life and survival.~   "
211729|NCT00789074|"~     Varenicline (Champix) is a relatively new medicine that is effective in helping people to~     quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24~     weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before~     stopping smoking is better than the standard 1-week of use prior to stopping.~      The study will recruit 100 smokers who want to stop. They will be randomly allocated to~     receive varenicline(4−weeks) or placebo (3−weeks followed by 1−week of active treatment as~     indicated by standard prescribing practice), followed by a 12−week open label treatment~     period where all participants will receive varenicline.~   "
211730|NCT00789061|"~     Disequilibrium between acid and base in the inner ear was suggested to be an important factor~     leading to hearing impairment associated with SLC26A4 mutations. For acid-base homeostasis in~     the inner ear, gastric-type proton pumps might demonstrate antagonistic effects to pendrin,~     the protein encoded by SLC26A4. To investigate whether proton pump inhibitors might prevent~     or treat acute fluctuating hearing loss related to SLC26A4 mutations, we launch the current~     double-blind randomized clinical trial.~   "
211731|NCT00789048|"~     Goal of the research~        1. To check the viability of Operating Table Position Simulating Radiographs, while~          positioned on the contralateral side.~        2. To determine whether knowledge about the angles displayed on this radiograph (pelvic~          tilt) influences the accurate positioning of the acetabular cup during the Total Hip~          Replacement procedure.~   "
211732|NCT00789035|"~     The objective is to investigate the efficacy, safety and pharmacokinetics of three different~     doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes~     mellitus with insufficient glycemic control. In addition an open-label metformin arm will be~     assessed~   "
211733|NCT00789022|"~     The goal of our research is to check the levels of D-Serine, Glycine, and other Glutamatergic~     amino acids, in patients with First Psychotic Episode (FPE). These patients are in the early~     stage of the disease, treated with neuroleptics for short periods of time, and are usually~     hospitalized for the first time. The hypothesis of the research is that we will find low~     levels of Glycine and D-Serine in these patients. Following an Anti-psychotic treatment we~     will expect these levels to return to the norm, and that this correction will be accompanied~     by a reduction of positive and negative symptoms.~      In addition, we will check the D-Serine and Glycine levels in the plasma of first degree~     relatives of the patients and a group of healthy subjects. The results of this study might~     support the hypothesis that the Glutamatergic system in involved in the pathology of~     Schizophrenia from it's early stages.~      In addition, we will check the levels of Oxytocin and Estrogen in the plasma of patients in~     FPE. Our hypothesis is that we will find low levels of Estrogen and High levels of Oxytocin~     in this group of patients. The results of the study might support the hypothesis that~     Estrogen and Oxytocin are involved in the pathology of Schizophrenia from it's early stages.~   "
211734|NCT00789009|"~     This study will investigate HIV infection and associated conditions by monitoring infected~     patients. The study will also serve as a means for recruiting HIV-infected individuals to~     NIAID s ongoing clinical and laboratory studies and supporting the institute s infectious~     disease training program by providing Infectious Disease fellows with ongoing training in the~     management of HIV infection.~      People 18 years of age and older with suspected or confirmed HIV infection who live in the~     Washington, D.C., metropolitan area may be eligible for this study. Physician referral is~     required.~      Participants come to the NIH Clinical Center a minimum of once every 3 to 4 months for~     evaluation with a physical examination; blood tests for research purposes, safety, immune~     status and viral load; and response to any treatment they may be receiving. Other procedures,~     such as a biopsy, are done only as needed for standard medical practice, and informed consent~     is obtained before any such procedure is done. Treatment offered is consistent with standard~     medical practice; no experimental treatments are offered under this protocol.~   "
211735|NCT00788996|"~     Main objective: to determine the effectiveness of a brief opportunist educational performance~     directed to the parents who smoke -- inside the context of programmed visits of paediatrics~     in primary care -- to reduce the exposure of the babies to secondhand smoke (SHS)~      Secondary objectives:~        1. Smoking reduction / quitting of the mother and/or the father~        2. To determine the relationship between the level exposure to SHS and main related~          variables~   "
211736|NCT00788983|"~     Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor~     combinations and various OEM pulse oximeter modules and sensor combinations during induced~     hypoxia (desaturation).~   "
211737|NCT00788970|"~     In the current study we will study the effect of adding acupressure (shiatsu) to conventional~     therapy in treating individuals with schizophrenia.~   "
211738|NCT00788957|"~     This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2~     part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab~     in combination with panitumumab versus panitumumab alone in patients with metastatic~     colorectal cancer whose tumors are wild-type KRAS status.~   "
211739|NCT00788944|"~     This is a study to determine the percentage of patients with depression who are treated with~     extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®) who are Poor Metabolizers~     (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down~     some medications and other chemicals).~   "
211740|NCT00788931|"~     The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both~     intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel.~     The study will evaluate safety and efficacy of the combination in adult female patients with~     HER2+ metastatic breast cancer~   "
211741|NCT00788918|"~     Patients with HCV infection often suffer from chronic fatigue, depression and reduced~     cognition, even before evolving severe liver fibrosis, liver cirrhosis and hepatic~     encephalopathy.~      It is currently unclear to what extent the symptoms er due to a direct pathological effects~     of the virus itself, or due to pre-existing psychiatric disease. There is a complex~     relationship between prior or existing drug abuse, psychiatric disease and HCV infection,~     that makes it difficult to establish cause-effect relationships.~      A biological mechanism has been suggested to contribute to development of cerebral~     dysfunction in the patients. According to the prevailing Trojan Horses hypothesis circulating~     lymphocytes cross the blood brain barrier carrying HCV to the central nervous system and~     virus is subsequently replicated in the macrophages and the microglia in brain as a separate~     compartment. As part of the immunological response to viral replication, neurodegenerative~     processes takes place with a harmful effect on the neural circuit and cerebral function.~     Identification of HCV RNA negative strand, a replication product, in brain tissue from HCV~     patients, as part of autopsy studies, supports the hypothesis. Moreover, HCV patients have~     also been observed with abnormal metabolic concentrations in the frontal white substance and~     the basal ganglia by MRI spectroscopy compared to control groups.~      The overall study objective is to assess cerebral function with particular emphasis on~     cognitive functions in HCV patients (genotypes 1,2,3 and 4) by use of a neuropsychiatric test~     battery. Furthermore, the patients will be examined by MRI, including magnetization transfer,~     diffusion tensor and contrast perfusion, in order to perform measurements of cerebral~     volumetric and microstructure. Finally, HCV analysis, including viral sequences and cytokine~     profiles, in serum and cerebrospinal fluid will be carried out in the study population.~   "
211742|NCT00788905|"~     The purpose of the study to determine whether the level of inflammation may be decreased, the~     lifespan of red blood cells increased and the clearance of waste products in the blood~     improved through the use of the Allient System as compared to conventional hemodialysis.~   "
211743|NCT00788892|"~     The study investigates if CPX-351 will be a) more effective than the standard AML treatment~     and b) more tolerable than the standard AML treatment regimens.~      The study compares the investigational product CPX-351 vs the standard treatment for AML in~     this patients age group.~   "
211744|NCT00788879|"~     The Tu Salud, Si Cuenta (TSSC) media campaign uses behavioral journalism, community outreach~     and environmental changes to promote physical activity and nutritional changes among~     disadvantaged Mexican-Americans living along the U.S./Mexico border. This intervention posits~     that increased physical activity and increased fruit and vegetable consumption with smaller~     portion sizes will result in a decrease in obesity prevalence and diabetes incidence in this~     population.~   "
211801|NCT00788073|"~     The study objective is to explore the efficacy, safety and tolerability of STX209 for~     treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve~     irritability and other typical problem behaviors associated with fragile X syndrome. We also~     hypothesize that STX209 will be safe and well tolerated.~   "
211745|NCT00788866|"~     Infants with intrauterine growth restriction are known to be at increased risk for long term~     neurodevelopmental delay into adulthood. The main mechanism for this is likely decreased~     blood flow to the brain secondary to altered placental blood flow. Antioxidants may serve to~     protect the developing brain from this process. Animal studies have shown that pomegranate~     juice protects the fetal brain from injury in a model of stroke. This clinical trial is~     intended to evaluate if giving mothers pomegranate juice during the last several weeks of~     pregnancy can help protect intrauterine growth restricted babies' brains.~   "
211746|NCT00788853|"~     This study is conducted in Asia. The aim of this observational study is to evaluate current~     status of diabetes management, control, complications in diabetic subjects in Asia. Further~     perceptions and practices of physicians and subjects about diabetes management in Asia will~     be evaluated.~   "
211747|NCT00788840|"~     This is a study designed to compare the effects of 2 long-acting insulins, detemir and~     insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic~     control and fat and muscle gene expression over a 6 month period.~   "
211748|NCT00788827|"~     This is a phase I study to assess the safety and tolerability of infusing expanded stem cells~     into the pancreas of patients with type I diabetes and a successful renal transplant. The~     stem cells used in this study occur naturally in the body and are collected from each~     recipient by a procedure called leukapheresis. The cells are then expanded and differentiated~     into insulin-like cells in a sterile suite before being injected into the body or tail of the~     pancreas of the recipient.~   "
211749|NCT00788814|"~     Study to assess the efficacy of a modified Pathways curriculum in treating depressive~     symptoms in women with physical disabilities.~   "
211750|NCT00788801|"~     This study is being done in healthy volunteers to help researchers understand how ABT-614~     works in the human body, specifically in the brain. The PET imaging technique can be thought~     of as a way to take pictures of chemical changes in the brain. To take a PET scan (picture),~     a substance with low levels of radioactivity (radiotracer) has to be injected when you are in~     the PET camera. The radiotracer is only radioactive for a short period of time. In this~     study, PET is being used to measure how the study drug attaches to specific receptors in the~     brain. The radiotracer used in this study, [11C]-(+)-PHNO, is currently being used for~     studies in people at the CAMH PET Centre.~   "
211751|NCT00788788|"~     Currently it is common medical wisdom that HELIOX (mixture of Helium in Oxygen) with a~     fraction of Helium below 60% is not effective in reducing airway obstruction. The~     investigators test the hypothesis that HELIOX with a fraction of Helium below 60% is still~     effective in relieving airway obstruction in a double-blind, randomized and controlled~     clinical PoC study with experimental upper airway obstruction.~   "
211752|NCT00788775|"~     Given the poor prognosis and limited treatment options available for patients with mucosal or~     acral/lentiginous melanomas who develop metastatic disease, genetic discoveries of KIT~     mutations in these cancers present the need to test multi-targeted kinase inhibitors with~     potent KIT inhibitory activity in this patient population. Imatinib and other tyrosine kinase~     inhibitors (TKIs) have the potential to be effective in this patient population, but patients~     may develop resistance to treatment. Therefore, in this study, we propose to test nilotinib~     in patients with metastatic mucosal, acral, or chronically sun-damaged melanoma following~     treatment with another TKI.~   "
211753|NCT00788762|"~     Taxiarchis, a small village in Northern Greece with 1060 inhabitants, was considered to have~     a surprisingly high incidence of glaucoma. This isolated population located on Mount~     Holomondas appeared to be enriched for familial glaucoma. Based upon the high reported~     incidence of glaucoma in Taxiarchis and previous findings of the Thr377Met myocilin mutation~     in the Greek population,the investigators undertook a community-based study to determine if~     this variant was present in this village.~   "
211754|NCT00788749|"~     This is the first randomized parallel group clinical trial looking at oral prednisolone~     induced medical nasal polypectomy followed by maintenance on topical steroid therapy in~     patients with nasal polyposis. This study also looks at the effect of aspirin sensitivity and~     the factors linking nasal polyps with asthma. We have also taken baseline measurements of a~     variety of blood, surface and biopsy markers to assess for potential to predict steroid~     response. Finally, the still unchartered link between nasal polyps and asthma will be~     explored by measuring Staphylococcal superantigens in serum before and after treatment.~   "
211755|NCT00788736|"~     The main objective of the study is to develop or validate a clinical prediction rule for~     major bleeding in patients on oral anticoagulant therapy who have been safely anticoagulated~     without bleeding or venous thromboembolism (VTE) recurrence for at least 3 months since~     diagnosis and are being considered for long-term oral anticoagulant therapy.~   "
211756|NCT00788723|"~     The aim of the study is to evaluate the cortical excitability in the severe brain injured~     patients. We hypothesize that:~        1. There is a continuous decrease in intracortical inhibition from healthy subjects to~          awake patients with severe brain injury, and to patients with impaired consciousness.~        2. Decreased intracortical inhibition correlate with the degree of impairment assessed with~          the clinical scores in patients with severe brain injury.~   "
211757|NCT00788710|"~     The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to~     placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.~   "
211758|NCT00788697|"~     The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound~     versus unenhanced ultrasound for characterization of Focal Liver Lesions using final~     diagnosis based on histology or combined imaging/clinical data as truth standard.~   "
211759|NCT00788684|"~     This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with~     rituximab in subjects with CD20-positive lymphoproliferative disorders. The extension portion~     of the study will allow active subjects to continue to receive ABT-263 for up to 9 years~     after the last subject transitions with quarterly study evaluations.~   "
211760|NCT00788671|"~     The goal of this clinical research study is to learn the level of effectiveness of the Mirena~     intrauterine device (levonorgestrel IUD) in treating hyperplasia of the lining of the uterus~     and/or early-stage cancer of the lining of the uterus. Researchers want to learn if the~     levonorgestrel IUD can help to shrink or slow the growth of the disease.~   "
211761|NCT00788658|"~     Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This~     condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and~     reduced quality of life. Options for treating IBS include pharmacotherapy, psychotherapy,~     hypnotherapy and cognitive behavior therapy (CBT). Available data on the effectiveness of CBT~     in IBS patients in Israel are scarce.~      The aim of the present study is to assess effectiveness of CBT as compared with standard~     therapy for IBS patients in Israel The course of CBT consisted of up to six 40 min sessions,~     and included education about IBS and techniques to reduce focusing on symptoms and to manage~     stress.Standard therapy includs life style modifications.~      The primary outcome measure was the score on a symptom-severity scale specific to IBS.~   "
211762|NCT00788645|"~     People with Chronic Obstructive Pulmonary Disease (COPD) often have periods during the year~     when their symptoms become worse. These are often due to an infection and are called~     exacerbations by doctors. Exacerbations are more common in the winter and also seem to be~     related to particular types of weather. As well as forecasting the weather the UK Met Office~     has developed a system to try to predict when exacerbations are likely to occur. The main~     purpose of this research study is to find out whether the Met Office forecasting service can~     predict when exacerbations are more likely to occur and whether the advice given during the~     predicted higher risk periods leads to fewer patients having an exacerbation or if it reduces~     the impact of the exacerbation. The study will also assess if there is a link between viral~     or bacterial infection and breathing problems that occur during the study period. The study~     will also collect information about possible causes of the breathing problems and what~     happens to the person afterwards. The results of this study will help us learn more about~     breathing problems which may lead to new research studies that would aim to improve the care~     of people with COPD.~   "
211763|NCT00788632|"~     The purpose of this study is to rigorously test the incremental impact of simple,~     generalizable interventions to improve healthcare among older women at high risk for~     osteoporosis. Building on the experience of our University of Alabama at Birmingham (UAB)~     interdisciplinary team we have designed an innovative, scientifically rigorous, and highly~     feasible implementation research project in partnership with two Kaiser Permanente (KP)~     research centers. Kaiser Permanente, one of the Nation's largest Healthcare Organizations,~     uses an integrated electronic medical record (EMR), with full capture of pharmacy, clinical~     (including BMD results), and claims data, and cares for a racially/ethnically,~     socio-economically, and geographically diverse population. To address innovative questions in~     implementation research, we will perform a multi-modal group randomized trial involving over~     18,000 patients seen by over 330 primary care providers (PCPs) at 25 KP facilities in the~     Northwest and Southeast. If proven effective, our system-centered and patient-centered~     approach will advance the state of implementation science and be applicable to evidence~     implementation in other musculoskeletal disorders and to other health care settings.~   "
211764|NCT00788619|"~     Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation~     of excess embryos allowing for multiple embryo transfer. Unfortunately this has also~     increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and~     mortality. The investigators believe that the concentration of nitric oxide metabolites~     measured in the culture medium from the first day of culture can identify the best quality~     embryos allowing us to transfer a limited number of embryos without compromising the optimum~     chance for pregnancy.~   "
211765|NCT00788606|"~     This study evaluates the use of the standard treatment R-CHOP plus the anti-VEGF drug,~     bevacizumab and whether this treatment is feasible in patients with stage II, III and IV~     diffuse large B cell lymphoma (DLBCL).~   "
211766|NCT00788593|"~     The primary efficacy objective of this study is to evaluate the difference in coefficient of~     fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low~     dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in~     participants with EPI associated with CP. This study is sponsored by Aptalis Pharma (formerly~     Eurand).~   "
211767|NCT00788580|"~     RATIONALE: Pazopanib and temsirolimus may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Pazopanib may also blocking blood flow to the tumor.~     Giving pazopanib together with temsirolimus may be an effective treatment for advanced solid~     tumors.~      PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus when~     given together with pazopanib in treating patients with advanced solid tumors.~   "
211768|NCT00788567|"~     This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept~     administered as a component of standard immunosuppressive therapy in recipients of kidney~     transplants. The anticipated time on study treatment is 3-12 months, and the target sample~     size is 100-500 individuals.~   "
211769|NCT00788554|"~     The aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair~     of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life,~     postoperative recovery and return to daily activities, complications and recurrences~   "
211770|NCT00788541|"~     The purpose of this study was to assess the effects of total volume and total dose on the~     safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and~     48 mg) in 0.5 mL and 0.8 mL volumes when administered by anterior juxtascleral depot (AJD)~     for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma~     or ocular hypertension.~   "
211771|NCT00788528|"~     The purpose of this open-label extension study is to evaluate the safety and efficacy of~     velneperit (S-2367) in obese subjects.~   "
211772|NCT00788515|"~     The primary objective is to compare the potential for next-day residual effects of~     volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning~     using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic~     primary insomnia and sleep maintenance difficulties.~      Secondary objectives are to compare the clinical safety of both products, including the~     potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to~     compare the efficacy of both products on subjective sleep parameters and to compare the~     effects of both products on patient's daytime functioning.~   "
211773|NCT00788502|"~     The goal of this study is to determine the effect of Healing Touch (HT) on the stress,~     anxiety, and self-efficacy experiences of women undergoing in vitro fertilization (IVF) in a~     randomized, controlled design. HT is a gentle, non-invasive form of energy-balancing work~     that promotes relaxation.~   "
211775|NCT00788476|"~     Objectives:~        1. To explore current lifestyle practices, health status, and quality of life among~          childhood cancer survivors and parent/guardians who are identified as primary~          caregivers.~        2. To explore childhood cancer survivors' and primary caregivers' awareness of future~          health risks.~        3. To explore interest in various lifestyle interventions and delivery channels among~          childhood cancer survivors and their primary caregivers.~        4. To explore factors which may serve as mediators or moderators of future lifestyle~          interventions that target childhood cancer survivors and their primary caregivers,~          e.g., strength of the caregiver-child bond, geographic distance from one another, and~          level of education.~   "
211776|NCT00788463|"~     The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol~     or spray is more effective in treatment of nasal polyps.~   "
211777|NCT00788424|"~     This protocol relates to a phase II randomized double blind, placebo controlled study of the~     AS101 topical application for the treatment of mild to moderate Psoriasis.~   "
211778|NCT00788398|"~     Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a~     common complication. There is currently little evidence as to which is the most effective way~     to wash out these wounds. This study is a multi-center, prospective, randomized study. The~     infection rates will be compared between irrigation using high pressure versus low pressure~     versus gravity flow, and also saline versus a soap solution as the irrigation solution. The~     results from this study will help to determine the best method of washing out open fractures~     wounds. In this study, all open wounds will be washed out using methods commonly used by~     orthopaedic surgeons~   "
211779|NCT00788385|"~     Multi-Center Study of ShuntCheck~   "
211780|NCT00788372|"~     The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day~     transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will~     enter the body through the skin) in participants with chronic (lasting a long time) pain.~   "
211781|NCT00788359|"~     Clinical and translational research in cystic fibrosis (CF) is hampered by a lack of~     biomarkers that can be used to identify promising new therapies. There is an urgent need for~     development and validation of biomarkers that more quickly predict the usefulness of~     potential drugs in CF and might prognosticate clinical course. In particular, combinations of~     protein biomarkers that can be obtained non-invasively offer great promise. The goal of this~     project is to determine whether protein biomarkers in blood can demonstrate a beneficial~     effect of treatment over two weeks. We intend to initially target an acute pulmonary~     exacerbation in CF because we know that subjects being treated with intravenous antibiotics~     and enhanced mucus clearance display clinical improvements within two weeks. We propose to~     prospectively collect blood samples from a large cohort of well-characterized CF persons~     serially during inpatient admissions for a pulmonary exacerbation and longitudinally during~     annual visits. Through this proposal, we hope to identify a CF lung injury biomarker panel~     that increases in the setting of an acute pulmonary exacerbation and improves rapidly~     following intravenous antibiotic therapy. Additionally, we will begin to explore whether this~     CF lung injury biomarker panel might also prognosticate clinical course including decline in~     pulmonary function. Finally, this study will serve as an important source of blood samples~     that will be banked for future biomarker and therapeutic studies designed to benefit the~     entire CF community.~   "
211782|NCT00788346|"~     Prescribing decisions by clinicians are often thought to be simple: a patient's clinical~     problem leads a prescriber to choose the optimal treatment. However, many factors other than~     the patient's condition affect prescribing decisions, including the marketing of~     pharmaceuticals. Clinicians are subjected to direct detailing by representatives of the~     pharmaceutical industry, advertisements in medical journals and requests for specific~     treatments from patients, who are increasingly exposed to direct-to-consumer (DTC)~     advertising. These influences, often based on biased or inaccurate information, contribute to~     a variety of problems in prescribing, including the unnecessary use of expensive, heavily~     marketed medications.~      Overcoming these influences requires innovative approaches. The movement toward widespread~     adoption of electronic health records (EHRs) and electronic prescribing presents new~     opportunities to educate both clinicians and patients at the time of medication prescribing.~     This project, endorsed by the AHRQ-supported Centers for Education and Research on~     Therapeutics (CERTs; www.certs.hhs.gov) and the U.S. Food and Drug Administration (FDA), aims~     to test the effectiveness of computerized prescribing alerts and state-of-the-art educational~     outreach to reduce the unnecessary use of heavily marketed medications. A second goal is to~     improve clinicians' knowledge of industry marketing practices, so that they can more~     effectively assess information provided by drug companies. Thus, the study has two specific~     aims:~      Specific Aim 1: To assess whether computerized prescribing alerts linked electronically to~     patient educational material can reduce prescribing of heavily marketed medications.~      Specific Aim 2: To assess whether group academic detailing increases clinicians' knowledge~     about industry marketing practices and increases the effect of prescribing alerts.~   "
211783|NCT00788333|"~     This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and~     pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with~     trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast~     cancer. In addition, the study is expected to identify the recommended dose or dose range of~     BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary~     evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab~     failure~   "
211784|NCT00788320|"~     Tuberculosis is a disease caused by a bacterium (a germ) that can cause illness in any organ~     of the body, but most frequently causes disease of the lungs. TB is short for tuberculosis.~     Treating TB requires several months (usually 6 months) of treatment, with the first 2 months~     being intensive treatment with usually four medicines. Treatment is needed to keep the~     infection from getting worse and to prevent death from TB.~      Vitamin D is a hormone present in the human body to manage levels of some essential~     electrolytes such as calcium and phosphate. Vitamin D is important for bone formation and~     prevention of bone breakdown (osteoporosis) as the investigators age. There is also new~     evidence that links vitamin D to function of our immune system as well. Even though our~     bodies can make vitamin D and can also obtain vitamin D from our diet, most adults,~     especially patients with tuberculosis have low vitamin D levels (are vitamin D deficient)~     that need to be corrected. Full correction of low vitamin D levels requires 6 weeks or more~     of weekly vitamin D supplements. There are several benefits to correcting vitamin D~     deficiency (better bone health, better balance of calcium and phosphate), but it is not known~     whether correcting vitamin D deficiency will lead to a better immune response to~     tuberculosis. Preliminary data does suggest that vitamin D increases the levels of an~     antimicrobial molecule (cathelicidin LL-37) in the body, possibly leading to better immunity~     against tuberculosis. The primary objective of this pilot study is to assess the relationship~     of vitamin D levels in patients with active pulmonary tuberculosis to levels of LL-37~     cathelicidin in sputum and whole blood. The results of this study are needed in preparation~     for larger studies that will evaluate the role of vitamin D supplementation as adjunctive~     therapy to standard medical treatment for tuberculosis.~   "
211940|NCT00786214|"~     Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders~     affecting humans. Existing therapies for FD are still far from satisfactory and new therapies~     are constantly being sought. Acupuncture has been used for the alleviation of functional~     gastrointestinal symptoms in several non-controlled studies. This study aims to investigate~     the therapeutic efficacy of acupuncture in patients with FD.~   "
211785|NCT00788307|"~     RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to~     tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer~     cells may help the prostate cells take in more radioactive iodine and thus kill the cancer~     cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of~     radioactive iodine.~      PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given~     together with radioactive iodine in treating patients with locally recurrent prostate cancer~     that did not respond to external-beam radiation therapy.~   "
211786|NCT00788294|"~     The hypothesis of this study is that subcutaneous administration of tanezumab results in~     lower drug exposure compared to intravenous administration of tanezumab.~   "
211787|NCT00788281|"~     Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However,~     whether it has the same survival benefit as the traditional open surgery in Chinese~     population is still unknown. So we designed this study to evaluate the 3 year disease free~     survival rate in the laparoscopic group versus the open surgery group.~   "
211788|NCT00788255|"~     Oxytocin is normally administered following delivery in pregnant patients to reduce~     postpartum bleeding by increasing uterine tone. It is unclear whether the use of intravenous~     oxytocin alters coagulation in pregnant patients. The purpose of the in-vitro study is to~     assess the coagulation changes of oxytocin in blood samples from pregnant patients using~     thromboelastrography (TEG). TEG is a point-of-care device which measures the viscoelastic~     properties of clot formation, and can provide rapid and detailed information about~     coagulation changes. We aim to collect blood samples from pregnant patients to assess the~     in-vitro effects of synthetic oxytocin on coagulation using TEG.~   "
211789|NCT00788242|"~     The purpose of this study is to evaluate the cardioprotective effects of a short term~     infusion of glucose-insulin-potassium (GIK) during heart surgery.~   "
211790|NCT00788229|"~     The purpose of this study is to determine whether artificial tears are safe and effective in~     the treatment of Dry Eye Syndrome.~   "
211791|NCT00788216|"~     Purposes of this study: 1) To define comprehensive set of descriptive health states related~     to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation,~     brachytherapy, chemoradiation) 2) To define set of descriptive health states related to~     adverse events associated w treatment of cervical cancer (i.e. bladder dysfunction, pain,~     enteritis, fistula formation) & 3) To derive, using a validated method, a set of QoL related~     utility scores corresponding to these health states.~   "
211792|NCT00788203|"~     This study is conducting preliminary testing to find out whether a particular educational~     program can alter parental overcontrol of their children's eating. There is evidence from~     previous studies that children who are irritable, cry a lot, tend to be overcontrolled and~     are at high risk for developing overweight. If the education program can change parental~     behavior the next study would examine whether this affects children's weight over a longer~     period of time.~   "
211793|NCT00788190|"~     The purpose of this study is to create and test a treatment algorithm to guide the treatment~     of distal radius fractures in patients 65 and older and to obtain level-one evidence to~     determine the best method of treating distal radius fractures in this growing population~     demographic.~   "
211794|NCT00788177|"~     The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular~     (exudative) age-related macular degeneration (AMD) when the first dose is administered to the~     submacular space instead of vitreous body in cases when previous state-of-the-art treatment~     for the AMD was deemed ineffective.~   "
211795|NCT00788164|"~     RATIONALE: Vaccines made from DNA or a gene-modified virus may help the body build an~     effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may~     stimulate the immune system in different ways and stop tumor cells from growing. Applying~     topical imiquimod to the cervix may be an effective treatment for cervical intraepithelial~     neoplasia. Giving vaccine therapy together with imiquimod may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy and~     to see how well it works when given with or without imiquimod in treating patients with grade~     3 cervical intraepithelial neoplasia.~   "
211796|NCT00788151|"~     This trial will evaluate the use of a tetravalent vaccine against dengue.~      Primary Objectives:~        -  To describe the immune response to dengue before and after each vaccination with dengue~          vaccine in two age cohorts of children previously vaccinated with yellow fever (YF)~          vaccine~        -  To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of~          children.~   "
211797|NCT00788138|"~     Vitamin D insufficiency is common in patients with cystic fibrosis. The investigators study~     will examine a large dose of vitamin D given to patients who have cystic fibrosis and are~     admitted to the hospital for a pulmonary exacerbation to determine whether vitamin D can~     improve clinical outcomes and whether the dose given is correct. The investigators hypothesis~     is that vitamin D therapy will improve production of anti-microbial peptides and will~     increase bacterial killing of microorganisms.~   "
211798|NCT00788125|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs in chemotherapy, such as ifosfamide, carboplatin, and~     etoposide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving dasatinib together with ifosfamide,~     carboplatin, and etoposide may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of dasatinib when~     given together with ifosfamide, carboplatin, and etoposide and to see how well they work in~     treating young patients with metastatic or recurrent malignant solid tumors.~   "
211799|NCT00788112|"~     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This clinical trial is studying how well vorinostat works in treating women with~     ductal carcinoma in situ of the breast.~   "
211800|NCT00788099|"~     Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Plitidepsin in~     Combination with Sorafenib or Gemcitabine in Patients with Advanced Solid Tumors or Lymphomas~     to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of plitidepsin in~     combination with sorafenib or gemcitabine in patients with advanced solid tumors or~     lymphomas.~   "
226640|NCT00591188|"~     The aim of this study is to determine preliminary efficacy of capecitabine and~     interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC~   "
211802|NCT00788060|"~     This is a single center, Phase Ib study of Sunitinib and RAD001 in patients with advanced~     RCC. The study design is a phase I interpatient dose-escalation with a dose expansion at the~     maximum tolerated dose (MTD) in patients with metastatic RCC . In the dose escalation~     portion, patients will be treated with sunitinib, given in an intermittent schedule (2 weeks~     of daily dosing followed by one week off drug. RAD001 will be given daily. Escalation of both~     drugs will occur as tolerated. Treatment will be arbitrarily divided into 3-week cycles, with~     dose limiting toxicity (DLT) determined by Cycle 2 Day 0.~   "
211803|NCT00788047|"~     This drug-drug interaction study is being conducted to evaluate the potential effect of~     Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450~     2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.~   "
211804|NCT00788034|"~     The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with~     Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.~   "
211805|NCT00788021|"~     Patients who undergo kidney transplant must take medications to prevent organ rejection.~     There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf),~     mycophenolate mofetil(Cellcept) or sirolimus (Rapamune) that are given to patients to prevent~     rejection. It is well known that patients on immunosuppressant medications are at increased~     risk from viral infections, such as influenza. However, it is not well understood how~     immunosuppressive medications may uniquely affect the immune response to infection. This~     study will determine whether there are unique differences in the effects on the immune system~     by these different immunosuppressive medications, particularly differences between tacrolimus~     and sirolimus.~   "
211806|NCT00788008|"~     The purpose of this research is to determine if post-operative cognition will be better if~     the general anesthesia for surgery is done with an inhaled (gas through a breathing tube) or~     intravenous (medicine injected in the IV) general anesthetic technique.~   "
211807|NCT00787995|"~     This multicenter, multinational, longitudinal study will quantify endurance and respiratory~     function in subjects diagnosed with MPS IVA and will better characterize the spectrum of~     symptoms and biochemical abnormalities in MPS IVA disease over time.~   "
211808|NCT00787982|"~     In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors~     that cannot be removed by surgery. Researchers want to find out if it is possible to use this~     new device in subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm)~     or smaller. The safety of the device will also be studied.~   "
211809|NCT00787969|"~     This phase I/II trial studies the side effects and best dose of temsirolimus when given~     together with cladribine and rituximab and to see how well it works in treating patients with~     newly diagnosed mantle cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere~     with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as~     cladribine, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving temsirolimus together with cladribine and rituximab may kill more cancer cells.~   "
211810|NCT00787956|"~     The Internet Chronic Disease Self-Management Program (ICDSMP) is a pilot study of our~     existing, previous approved, Chronic Disease Self-Management Program Online. The online~     programme will be offered to 300 people with chronic disease in South Australia and evaluated~     for effectiveness, as well as satisfaction of both the South Australian peer facilitators and~     the participants with chronic disease. All participants will be recruited by the State of~     South Australia, after which they will complete informed consent and a questionnaire on a~     secure website housed at Stanford. They will take a 6-week online self-management program in~     groups of 20-25, and they fill our additional online questionnaires at 6 month and one year.~   "
211811|NCT00787943|"~     This study is a split face, paired-comparison, pilot study of 10 subjects. Participants in~     this study will be patients seen at Children's Memorial Hospital, who are clinically~     diagnosed with mild to moderate acne vulgaris. Participants will be recruited from the~     clinic, as well as advertising and from previous Institutional Review Board (IRB) approved~     acne studies housed in the Department of Dermatology. All subjects accrued from previous~     studies have agreed to be contacted for further investigations. Subjects 13 to 35 years of~     age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face,~     and meeting inclusion criteria will be eligible to participate.~   "
211812|NCT00787930|"~     The purpose of this study is to look at certain structural changes in the brain in people~     with bipolar disorder or those with a history of Bipolar disorder.~   "
211813|NCT00787917|"~     This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic~     Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and~     older.~   "
211814|NCT00787904|"~     This is an observational study of women undergoing surgical menopause to determine whether~     T-cells play an important role in the etiology of post-menopausal osteoporosis. Subjects will~     examined before and after surgery and followed over a two year period to determine the~     biology of T-cells during this study period.~   "
211815|NCT00787891|"~     The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the~     treatment of acid-related disorders in pediatric patients, focusing specifically on the~     manifestation of GERD (symptomatic and erosive types).~   "
211816|NCT00787878|"~     The study is conducted in Europe. The primary aim of this observational study is to compare~     the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin®~     with untreated small for gestational age (SGA) subjects and with average for gestational age~     (AGA) subjects.~   "
211817|NCT00787865|"~     This study is designed to learn about early brain development in children with Krabbe~     disease, and to use diffusion tensor imaging as an early diagnostic tool to identify newborns~     at risk for the disease.~   "
211818|NCT00787852|"~     The purpose of this study is to evaluate if a maximum dose of 100 mg of dasatinib with~     concurrent chemoradiation can be tolerated in patients with chemotherapy naive stage III~     NSCLC in separate cohorts of locally advanced and potentially resectable disease.~   "
219195|NCT00689871|"~     Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women~     undergoing primary augmentation, primary reconstruction, or revision of existing breast~     implants.~   "
211819|NCT00787839|"~     People who might have prediabetes or unrecognized diabetes will be screened for these~     problems at an outpatient visit. For screening, they will take a sugary drink containing 50~     grams of glucose, and have a blood sample one hour later. The blood sample will be tested for~     glucose and A1c (a measure of blood glucose over the previous two months). They will also~     fill out questionnaires that ask about their health history and how they would feel about~     exercising and trying to lose weight if they are found to have prediabetes or diabetes. At a~     subsequent visit, they will have an oral glucose tolerance test (OGTT) - a blood sample, then~     a sugary drink containing 75 grams of glucose, and a repeat blood sample 2 hours later. We~     will evaluate the costs of finding out if people have prediabetes or diabetes. For people who~     are found to have these problems, we will also evaluate how well their doctors treat these~     problems.~   "
211820|NCT00787826|"~     This study is designed to determine the safety and immunogenicity of a Live Francisella~     tularensis Vaccine~   "
211821|NCT00787813|"~     The aim of the study is to evaluate the effect of N-acetyl cysteine (NAC) on pregnancy~     outcome in women undergoing cervical cerclage for cervical insufficiency.~   "
211822|NCT00787800|"~     The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention~     and termination therapies, minimized ventricular pacing, and remote monitoring will reduce~     the rate of inappropriate shocks and improve quality of life compared to optimally programmed~     back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac~     death~   "
211823|NCT00787787|"~     This phase II trial studies how well giving sunitinib malate together with capecitabine works~     in treating patients with unresectable or metastatic liver cancer. Sunitinib malate may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving sunitinib malate together with capecitabine may kill more tumor~     cells~   "
211824|NCT00787774|"~     Prospective study to evaluate the potential persistent viral effect of raltegravir in 20~     treatment experienced HIV patients with incomplete viral suppression~   "
211825|NCT00787761|"~     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop~     the growth of cancer cells. It may also stop the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune cells and help~     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     antithymocyte globulin before the transplant and tacrolimus and methotrexate after the~     transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with~     cyclophosphamide, busulfan, and fludarabine works in treating patients with hematological~     cancer or kidney cancer undergoing donor stem cell transplant.~   "
211826|NCT00787748|"~     The prevalence of chronic obstructive pulmonary disease (COPD) in patients with~     cardiovascular disease (CVD) is unknown, and whether or not COPD is adequately diagnosed and~     treated in these patients has not been investigated before.~      We hypothesized that the prevalence of COPD would be significantly higher (30%) in patients~     with CVD than in the general population. Besides, we anticipated that COPD, a potentially~     treatable CV risk factor, would be undiagnosed in more than 80% of CVD patients.~   "
211827|NCT00787735|"~     This research is being done to:~        -  identify any emotional, behavioral or other troubling psychological problems that some~          people have who are seeking and receiving treatment for heroin or other drug use~          problems,~        -  learn if providing additional psychiatric treatment services in the ATS drug abuse~          treatment program is as beneficial for and acceptable to patients as referring them to~          the Bayview Community Psychiatry Program to get help for their emotional, behavioral and~          other psychological problems.~   "
211828|NCT00787722|"~     This study is designed to examine whether treating Devic's disease patients with high dose~     cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune~     system), followed by return of previously collected patient's stem cells will result in~     improvement in Devic's disease. Stem cells are undeveloped cells that have the capacity to~     grow into mature blood cells, which normally circulate in the blood stream. The purpose of~     the intense chemotherapy is to destroy the cells in patient's immune system, which may be~     causing his/her disease. The purpose of the stem cell infusion is to produce a normal immune~     system that will no longer attack patient's body. The purpose of study is to examine the~     safety and efficacy of this treatment. The drugs used in this study treatment are drugs for~     commonly used for immune suppression.~   "
211829|NCT00787709|"~     The proposed project takes an innovative approach to childhood obesity prevention, for which~     there currently no evidence-based programs, and for which results of current trials have~     produced mainly short-term or disappointing effects. The aim of this project is to adapt and~     revise parts of two nationally recognized programs for drug prevention for use with children~     in grades 4-6 with the express purpose of obesity prevention. The current study will attempt~     to promote emotion regulation, neuro-cognitive function, and social competence in order to~     prevent obesity. A total of 24 elementary schools from two of the largest districts in Orange~     County will be randomly assigned to either the obesity prevention program or control group~     (N=1587) 4th grade students and their parents). A cohort of students will be followed from~     the 4th through 6th grades. Intervention students will be administered the Pathways obesity~     prevention program by trained teachers. The population is ethnically diverse (36% white, 57%~     Hispanic, 6%Asian; 48% on free/reduced lunch programs). Self-report measures, BMI, and waist~     circumference will be administered at the beginning of 4th grade, and at end of 4th , 5th ,~     and 6th grade. Teacher, administrative, and parent surveys will be administered on the same~     schedule to measure school environment. Program implementation will be measured by teacher~     self-report and research staff observations. Data will be analyzed with statistical~     approaches that capture effects of school and classroom, test the theoretical model of~     change, and evaluate developmental trends in mediators and outcomes across the three grades.~     Findings should be generalizable to most elementary schools, and will be used to develop~     evidence-based program standards for childhood obesity prevention.~   "
219196|NCT00689858|"~     TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase~     I study in healthy Volunteers were designed~   "
211830|NCT00787696|"~     This project assesses the efficacy of an HIV prevention program with adolescent females~     incarcerated in the Mississippi training school for girls. Participants in both the health~     education control group and the HIV prevention group will increase health knowledge as a~     result of their participation in the health classes while incarcerated. However, participants~     in the HIV prevention group will increase their condom application, assertiveness, and~     communication skills relative to girls in the health education only group. In addition, after~     release from the training school, participants in the HIV prevention group will report lower~     sexual risk behaviors and will have lower rates of infection with chlamydia and gonorrhea~     during the 12-month follow-up period than participants in the health education only group.~   "
211831|NCT00787683|"~     The purpose of this study is to investigate the cost-effectiveness and effectiveness of~     remote-monitoring compared to standard care in patients with implantable cardioverter~     defibrillator.~   "
211832|NCT00787670|"~     This research is a NIH single site study with the aims to (1) determine whether surgically~     induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. (2)~     elucidate the mechanisms by which surgically induced weight loss reduces over time the risk~     of CVD in morbidly obsess subjects with T2DM.~      Study'subjects will be enrolled from obese individuals with type 2 diabetes (T2DM). The study~     includes two groups, subjects undergoing gastric bypass surgery and a control group not~     undergoing weight loss surgery. A total of 60 subjects (30 in each group) will be recruited.~      Basal, 6 and 12 months assessments will include: insulin sensitivity determination,~     cardiovascular function by echo doppler, and DEXA scan.~      This study involves risk-level II procedures, however, the risks inherent to the gastric~     bypass surgery are not considered study-derived because subjects are enrolled from~     individuals that have already decided to have this surgery. We will determine protein~     expression profiles of inflammation-related adipokines in the subcutaneous and~     intra-abdominal adipose tissues of morbidly obese subjects with T2DM before and after~     surgically induced weight loss.~   "
211833|NCT00787657|"~     -  The Study analyses the influence of selected factors on adherence to Betaferon treatment~          in patients with early multiple sclerosis (MS). The Investigator will document the~          relevant medical data regarding multiple sclerosis at every hospital visit, the patient~          will fill in two questionnaires at every visit: one about coping with the disease and~          the other about anxiety and depression.~        -  The Study particularly looks at the role of the support of the patient given by the~          multiple sclerosis nurses.The nurse will provide additional standardised information at~          start of treatment and will regularly phone the patient to ask standardised questions~          about the general condition with regard to the treatment, the disease and social~          support. At the end of the Study it will be assessed if the supportive measures and the~          standards in terms of adherence management in the hospital have some influence to~          increase long-term treatment adherence.~   "
211834|NCT00787644|"~     Asthmatics who are significantly overweight tend to have more severe symptoms, more flare~     ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.~      Researchers believe this occurs because excess adipose tissue (fat) in the bosy can cause~     higher-than-normal levels of leptin and lower levels of adiponectin in the blood.~      The researchers of this study are testing a medication called pioglitazone in overweight~     asthmatics because they believe it can help regulate leptin and adiponectin and that this may~     improve symptoms of asthma.~   "
211835|NCT00787631|"~     A high number of birch pollen-allergic individuals develop hypersensitivity reactions to~     certain foods, e.g. apples. This food allergy is due to immunological cross-reactivity. Birch~     pollen-related foods contain proteins, e.g. Mal d 1 in apple, that are structurally related~     with the major birch pollen allergen, Bet v 1. Hence IgE antibodies and T lymphocytes~     specific for Bet v 1 recognize these food proteins which results in activation of the immune~     system and, consequently, in clinical symptoms.~      In the present study the investigators intend to investigate if and how the consumption of~     birch pollen-related food allergens affects birch pollen allergy. In other words, the~     investigators are interested to analyse whether Bet v 1-related food allergens activate Bet v~     1-specific memory cells and thus, contribute to the maintenance of the pollen allergy outside~     the pollen season. Data obtained in this study will help to clarify the immunological and~     clinical role of cross-reactivity between pollen and food allergies and will reveal whether~     avoidance of such foods should be recommended for the patients. Finally, novel approaches for~     diagnosis and therapy of pollen-related food allergens can be developed.~   "
211836|NCT00787618|"~     PK and safety profile of Proellex® in females with various stages of impaired renal function~   "
211837|NCT00787605|"~     The purpose of the study is to evaluate the blood pressure lowering effect and safety of~     aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with~     stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and <~     200 mm Hg).~   "
211838|NCT00787592|"~     The objective of this study is to evaluate the outcomes of children with burn injury with~     regard to the utilization of Silver sulfadiazine (SSD) cream and Collagenase ointment. The~     primary outcome variable will be need for skin grafting. The specific aim of the study is to~     prospectively collect data to determine if SSD is superior to Collagenase with regard to~     avoiding the need for skin grafting.~   "
211839|NCT00787579|"~     1. To determine if the effect of near-addition lenses (bifocals) is more prominent for~          children with high myopia progression.~        2. To study how different subject characteristics such as age, gender, baseline degree of~          myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of~          bifocal lens wear in myopic children.~        3. To investigate the effect of incorporating near base-in prisms along with the~          near-addition lenses (prismatic bifocals) on myopia progression in myopic children.~   "
211840|NCT00787566|"~     Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2~     dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with~     chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly~     emetogenic chemotherapy.~      Primary Objective: To select a dose for Phase 3 by assessing the efficacy, safety, and~     tolerability of 3 doses of TRG in patients with CINV associated with the administration of~     highly emetogenic chemotherapy.~   "
233205|NCT00503633|"~     The purpose of this study is to identify biological markers, including genes, associated with~     sleep disturbance and other symptoms among people with HIV.~   "
211841|NCT00787553|"~     Purpose: to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the~     febrile and infectious morbidity after vaginal or abdominal hysterectomy. Methods: A~     randomized clinical trial carried out at the Women's Integrated Healthcare Center~     (CAISM)/UNICAMP, Campinas, Brazil. Women undergoing to total vaginal or abdominal~     hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis:~     tinidazole, cefazolin or an association of both.~   "
211842|NCT00787540|"~     Chest pain, illness perception compliance and psychosocial outcome after coronary~     arteriography. A comparison between patients which were diagnosed with slow coronary flow and~     patients who have been diagnosed with coronary artery occlusion. We hope to prove that the~     more knowledge and awareness the patient has about his disease the better his compliance and~     rehabilitation.~   "
211843|NCT00787527|"~     The goal of this clinical research study is to find out how well the drug Zolinza~     (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide,~     doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell~     Non-Hodgkin's Lymphoma (NHL). The safety of these drugs in combination and the best dose of~     vorinostat when given in combination with CHOP will also be studied.~   "
211844|NCT00787514|"~     The folate receptor (FR) is a cell over expressed on the surface of certain cancers, this~     occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however~     in these normal tissues, the FR is usually located on the tissue surface that is inaccessible~     to circulating drugs. As such, drugs which target the FR may potentially be used to target~     cancers which overexpress the FR while reducing toxicity to normal tissues. Therefore the~     ability to measure FR levels from different cancer types may help to select patients who are~     most likely to benefit from treatment with FR targeted therapies. Once such drug BGC945 is~     currently being tested in preclinical study at the Institute of Cancer Research~   "
211845|NCT00787501|"~     Our goals are 1) to use functional magnetic resonance imaging (fMRI) to predict which~     depressed individuals will respond to different validated treatments for unipolar depression~     including Cognitive Therapy (CT) and antidepressant medications (selective serotonin reuptake~     inhibitors; SSRIs) and 2) to understand whether CT and SSRIs affect similar aspects of brain~     function underlying cognition and emotion. Thus, we will examine depressed adults ages 18-55~     using fMRI during cognitive and emotional information processing tasks, before and after~     treatment with an SSRI (n=25) or CT (n=40). We hypothesize that: 1) Recovery will occur in~     treatment with an SSRI primarily for individuals with increased reactivity in limbic brain~     regions associated with emotion generation and prefrontal regions associated with~     regulation,. 2) Recovery with CT will occur for patients with increased activity in brain~     regions associated with emotion generation but decreased activity in prefrontal regions~     associated with emotion regulation. 3) Recovery with an SSRI will yield similar changes in~     brain function to CT in brain regions associated with emotion generation but less change in~     brain regions responsible for emotion regulation such as the prefrontal cortex. Findings from~     this study may have a profound impact on reducing the burden of clinical depression by~     providing evidenced-based diagnostic and treatment guidelines.~   "
211846|NCT00787488|"~     This is a pilot study aimed to test the feasibility and safety of administering combination~     chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin~     (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of~     optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube~     cancer patients.~   "
211847|NCT00787475|"~     The objective of this study is to examine the effectiveness of a community health worker~     intervention at helping to control diabetes among Latinos with poorly controlled Type 2~     diabetes.~      Hypothesis: Compared to those in Enhanced usual care group, patients randomized to the~     intervention will, at 12 months, have greater reductions in: (1) HgA1C; (2) low density~     lipoprotein (LDL); and (3) systolic and diastolic BP.~   "
211848|NCT00787462|"~     Idiopathic Small Fiber Neuropathy (called SFN for short), is a condition where nerves that~     sense pain have become damaged, and often painful. SFN pain is common, and it can affect~     sleep, memory, health and overall quality of life.~      Pregabalin is a drug commonly used to treat painful conditions, like nerve pain. It has been~     available to doctors for many years, and many studies have been performed to evaluate its~     effectiveness. In these studies, pregabalin has been shown to be very effective in the~     treatment of nerve pain, with fewer side effects than many other medications currently~     available. The purpose of the study is to determine if pregabalin relieves pain more~     effectively than a pill containing no medication (called a placebo). The study will also~     investigate any side effects as well as the effectiveness and safety of the medication.~   "
211849|NCT00787436|"~     The natural history of cirrhosis has a symptomatic and asymptomatic stage. The symptoms~     include the development of ascites, hepatic encephalopathy, or variceal bleeding. The~     development of portal hypertension represents a critical transition point in the natural~     history of cirrhosis, contributing to, or directly responsible for all of these events. It is~     defined by an increase in intrahepatic vascular resistance to portal venous inflow, with the~     subsequent development of collateral vessels, such as esophageal or gastric varices. As~     portal pressures rise over time, however, the resulting increase in variceal size and wall~     tension translates into an increasing likelihood of rupture and bleeding, leading to death in~     about 30% of patients. Over the last twenty years, data have emerged regarding the role of~     tumor necrosis factor (TNFα) in portal hypertension from animal models as well as in vitro~     experiments. Portal hypertension is a condition characterized by vasodilatation and a~     hyperdynamic circulation, driven by relative overproduction of nitric oxide23. In animal~     trials using inhibitors of TNF it has been shown to decrease the development of the~     hyperdynamic circulatory state and portal pressure.24-25 Based on these data, investigators~     have examined the role of TNF inhibition with thalidomide. Significant improvement in~     blocking the development of the hyperdynamic circulation and portal pressures was~     demonstrated.26 Human trials have also show the efficacy of thalidomide in reducing portal~     pressures. In that these trials have shown promising results further investigation is~   "
211982|NCT00785668|"~     This is a single centre, single dose pharmacokinetic/safety study in male and female~     asthmatic subjects. Subjects will receive a single dose of 10 mg of AER 001 administered as a~     dry powder using a handheld device. The goals of this study are to understand the~     pharmacokinetics and safety of AER 001 administered as a dry powder in mild to moderate~     asthmatics.~   "
211850|NCT00787423|"~     Background:~      - Researchers are interested in developing more accurate methods to assess environmental~     influences on psychological stress and drug use. One key to a more accurate assessment of~     environmental influences is minimizing the delay between exposure and reporting. Portable~     devices such as personal digital assistants (PDAs) and global positioning system (GPS) units~     may be able to provide a more real-time image of these factors.~      Objectives:~      - To assess the use of PDAs to measure stress and drug use, and GPS units to assess the~     effects of neighborhood environment in an outpatient treatment population.~      Eligibility:~        -  Individuals from 18 to 75 years of age who are current heroin users seeking treatment~          for addiction and who spend most of their time in Baltimore city.~        -  Participants must be able to visit the research and treatment center at least three~          times per week for regular tests.~      Design:~        -  Participants will be in the study for approximately 28 weeks (7 months).~        -  A series of three laboratory session examining responsiveness to standardized stressors~          will occur both early in treatment and will be repeated late in treatment.~        -  Participants will undergo 18 weeks of daily methadone maintenance. Urine samples will be~          collected three times weekly.~        -  To track drug use, stress, and geographical location (a measure of environmental risk),~          each participant will carry a PDA and a GPS unit for 16 of the 18 weeks. Participants~          will make entries (1) each time that they use a drug and (2) each time they feel~          overwhelmed, anxious, or stressed more than usual. Participants will also make three~          random-signal-triggered recordings per day and one brief (end of day) recording.~        -  Retrospective self-report questionnaires on drug use and stress will be given regularly.~        -  After 18 weeks of methadone maintenance, participants will discontinue carrying the PDA~          and GPS unit and will have the choice of transferring to a community clinic or~          undergoing a 10-week taper from methadone at the research clinic. Participants who stay~          for the taper will continue to provide urine samples, but only once a week.~   "
211851|NCT00787410|"~     This study is a multicentre, open label, non-comparative, two stage phase II trial to assess~     the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will~     receive trial treatment as first-line therapy, administered continuously once daily until the~     completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity or~     withdrawal of consent. Patients continuing to show evidence of response, disease~     stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond~     completion of the trail.~   "
211852|NCT00787397|"~     The purpose of this study is to assess whether improving sleep in children and adolescents~     with anxiety disorder will further enhance affective, clinical, and social functioning.~   "
211853|NCT00787384|"~     The study was performed to assess: 1) clinical activity of Imatinib in patients with HES, CEL~     and CIH; 2) correlation between Imatinib activity and specific disease subtype; 3) long-term~     outcome of HES, CEL and CIH patients treated with Imatinib; 4) safety and tolerability of~     Imatinib administration.~   "
211854|NCT00787371|"~     In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver~     histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma~     (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore,~     the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW)~     PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese~     patients with chronic hepatitis C.~   "
211855|NCT00787358|"~     The purpose of this research study is to test if an experimental drug called ZT-031 can help~     men over 30 years or post-menopausal women over 55 years of age with certain types of hip~     fracture to heal better or faster following surgery and to determine if ZT-031 is safe for~     patients with fractures. To be allowed in the study you have to have a type of hip fracture~     that requires surgery that is being studied (intertrochanteric fracture). You must also~     otherwise be in good health, with no serious diseases such as cancer, neurologic disease,~     other bone disease, liver, heart or kidney disease. You must be able to inject yourself every~     day with the study medication using an injection pen, like that used for insulin injections.~   "
211856|NCT00787345|"~     Central line associated bloodstream infection (CL-ABI) is an important and preventable cause~     of nosocomial infections and is responsible for considerable morbidity and mortality The~     Centers for Disease Control have published guidelines for the prevention of CL-ABI that~     represent a collaborative effort by a multidisciplinary coalition of professional~     organizations that provide evidence based recommendations to prevent catheter related~     infections [5]. The interventions emphasize five distinct practices, including: education and~     training of healthcare providers who place and care for catheters, utilizing maximum sterile~     barrier precautions during catheter placement.~   "
211857|NCT00787332|"~     Compare Clinical Success and Costs in two Arms~   "
211858|NCT00787319|"~     To define what procedures were used for the diagnosis and monitoring of the treatment~     age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with~     Macugen treatment, safety profile of Macugen, final physician assessment of treatment with~     Macugen.~   "
211859|NCT00787306|"~     Cardiovascular diseases remain the main cause of mortality in Canada. While effective~     interventions are available for reducing the risk of cardiovascular disease,there continue to~     be gaps between the potential reduction in risk that could be achieved by effectively~     managing these risk factors and levels of risk factor control currently in clinical practice.~     This study will evaluate the ability of a different model of risk factor care using other~     health providers assisting family doctors, along with information aids for patients and~     health professionals,to achieve better levels of cardiovascular risk factor control in~     adults.~   "
211860|NCT00787293|"~     Improvement in heart failure with moderate to severe mitral regurgitation using a~     percutaneously delivered implantable device.~   "
211861|NCT00787280|"~     To evaluate whether changes in macronutrient consumption (i.e., switching to a diet low in~     carbohydrates) can change brain responses to cues depicting foods representing that~     macronutrient. In addition to answering specific questions regarding the effects of an LCKD,~     the study will provide general information about relations between brain responses to food~     cues and a broad arrive of factors including typical diet, food preferences, weight control~     history and genes.~   "
211862|NCT00787267|"~     On this study patients will receive dasatinib, a targeted therapy, for advanced NSCLC that~     has progressed after previous therapy. Safety and response to dasatinib will be assessed.~      Fresh frozen tumor tissue must be available for genomics analysis prior to initiating~     dasatinib therapy. A biopsy must be obtained after any prior chemotherapy. If fresh frozen~     tumor tissue is not available, a biopsy will be required to participate in this trial.~   "
211863|NCT00787254|"~     The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is~     effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving~     long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice~     daily (BID).~   "
227545|NCT00579046|"~     The purpose of this study is to determine the impact of erythropoietin treatment of anemia on~     exercise capacity of patients with chronic obstructive pulmonary disease (COPD).~   "
211864|NCT00787241|"~     Thrombocytopenia (platelet count < 100,000/mL) occurs in approximately 15% of women with~     preeclampsia. Neuraxial analgesia is contraindicated in parturients with a coagulopathy;~     therefore, the platelet count(PC) is routinely checked prior to the initiation of neuraxial~     analgesia in women with preeclampsia/eclampsia. Catheter removal is also contraindicated in~     the presence of a coagulopathy. Some women have an acceptable PC at the initiation of~     neuraxial analgesia, but may become significantly more thrombocytopenic during labor and~     delivery. In a study of severely preeclamptic parturients, some with HELLP (H=hemolysis of~     red blood cells, EL=elevated liver enzymes, LP=low platelet count) syndrome, the admission PC~     correlated with the PC nadir. However, the natural progression of the PC has not been studied~     in women with mild preeclampsia. We hypothesize that women with mild preeclampsia or severe~     preeclampsia without HELLP syndrome, and whose admission PC is greater than 150,000/mL, will~     have a stable PC during the course of labor and delivery and do not require another PC check~     prior to initiation of neuraxial analgesia or removal of the epidural catheter. The purpose~     of this study is to determine the positive predictive value of an initial PC greater than~     150,000/mL for maintaining a PC greater than 80,000/mL during labor and delivery.~   "
211865|NCT00787215|"~     Hypothesis: There is a high rate of glucose intolerance among Hong Kong Chinese.~      The investigators plan to screen Hong Kong Chinese from the community with oral glucose~     tolerance test (OGTT). The subjects will be referred from GP centers in the community and~     self-referred with public advertisement on this survey.~   "
211866|NCT00787202|"~     The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo~     (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.~   "
211867|NCT00787189|"~     The purpose of this clinical study is to determine the effectiveness of low level laser light~     therapy when applied around the head and ears in improving unaided word recognition in ears~     with sensorineural hearing loss.~   "
211868|NCT00787176|"~     Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal~     status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by~     approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables~     which could affect fetal heart rate patterns at the time of initiation of analgesia, such as~     fluid administration and oxytocin management, could help us provide better care for our~     patients and their fetuses.~      Hypotheses: The combination of fluid administration and lower doses of oxytocin~     administration will have fewer adverse fetal heart rate changes in the first 60 minutes~     following initiation of labor analgesia.~   "
211869|NCT00787163|"~     The aim of this study is to compare perinatal survival in patients presenting with early~     spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with~     serial amnioinfusions.~   "
211870|NCT00787150|"~     To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on~     the composite endpoint of major and clinically relevant non-major bleeding during the~     treatment period.~   "
211871|NCT00787137|"~     The primary objective is to evaluate the safety and tolerability of a single intravenous dose~     of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how~     PG102 moves around the body and to explore its effects on the disease.~   "
211872|NCT00787124|"~     The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused~     blood of extremely preterm infants. The long term goal of the project is to identify~     variation in the SNO-Hb between packed red blood cell units, and between and among individual~     preterm infants pre and post-transfusion. Duke investigators are developing methods to~     replenish SNO-Hb, which, if successful, would improve RBC deformation in addition to~     providing a vasodilatory stimulation to hypoxic tissue, and lead to a randomized clinical~     trial testing treated vs. untreated RBC transfusions in extremely premature infants.~      AIM 1. Measure the Total Hemoglobin (Hb)-bound nitric oxide (NO), Hb [Fe] NO, SNO-Hb (a~     calculated value = (total Hb-NO - Hb [Fe] NO) in blood to be transfused in extremely preterm~     babies, and in samples pre and post- transfusion from the babies.~      Hypothesis 1: Measures of NO and SNO-Hb will be low in blood used for transfusion in preterm~     infants and will be decreased in the post-transfusion samples from the infants compared with~     the pre-transfusion samples.~      AIM 2. Collect clinical data about study participants, including oxygen saturation and~     measures of perfusion pre and post-transfusion.~      Hypothesis 2: Measures of perfusion will be reduced by 20% post-transfusion in extremely~     preterm infants.~   "
211873|NCT00787111|"~     This open-label research study will continue to monitor the safety of fluoxetine in children~     after their completion of a previous double-blind placebo controlled clinical study, with~     fluoxetine. The study will also look at the effect of fluoxetine on IQ (Intelligence~     Quotient) over an 18 month period.~   "
211874|NCT00787098|"~     The purpose of this study is to compare the effects of specific activities with and without~     an early therapeutic mobility (ETM) protocol among patients who experience three or more days~     of mechanical ventilation. A second purpose is to examine staff/delivery system and patient~     factors that influence the initiation and progression of activity with and without an ETM~     protocol. The hypothesis is that ETM protocols will result in improved patient outcomes.~   "
211875|NCT00787085|"~     This investigation is a epidemiologic case-control study of the risk factors associated with~     nosocomial funguria (fungi in the urine).~   "
211876|NCT00787072|"~     The aim of this study is to assess the safety, tolerability and pharmacokinetics of single~     ascending oral doses of AZD8075 in healthy male volunteers~   "
211877|NCT00787059|"~     This research study is designed to determine: 1) whether gene transfer using an agent called~     Ad5.hAC6 (adenovirus-5 encoding human adenylyl cyclase type 6) can be given safely to~     patients with congestive heart failure (CHF) and 2) whether this agent may be of benefit in~     heart failure. Gene transfer is a process by which genes are introduced into cells and the~     cells then produce the specific protein that the gene directs, in this case, a protein known~     as adenylyl cyclase type 6 (AC6). The gene is carried into the heart cells by a modified~     virus. The virus that is modified is an adenovirus (Ad5), a virus that sometimes causes a~     brief cold. In extensive animal experiments, it was found that increased amounts of AC6~     protein in heart cells appeared to make the heart pump more vigorously.~   "
211983|NCT00785655|"~     To demonstrate the absence of irritation potential (primary dermical irritability and~     cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd~     PHDETINLYN Sweet Flower.~   "
211878|NCT00787033|"~     Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase~     (FAK) inhibitor PF-04554878 in patients with advanced non-hematologic malignancies, including~     patients with malignancies appropriate for serial biopsy. Screening consists of medical~     history, physical examination ECOG performance status, blood draws, a pregnancy test for~     female patients of childbearing potential, a FDG-PET and tumor imaging. Treatment consists of~     PF-04554878 pills continued until progression of disease, unacceptable toxicity, or patient~     request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for~     biomarkers related to FAK and Pyk2 activities.~   "
211879|NCT00787020|"~     The purpose of this study is explore how cerebrospinal fluid (CSF) drainage impacts outcomes~     for patients diagnosed with subarachnoid hemorrhage (SAH). This is a non-randomized~     observational study of two physician-prescribed approaches to managing intracranial pressure~     monitoring and CSF drainage for SAH patients. The study will enroll only those patients who~     have intracranial pressure (ICP) monitoring in situ. Because this is an observational study,~     there are no physical risks to the patient, the only risk is loss of confidentiality.~   "
211880|NCT00787007|"~     The purpose of this study is 1) to test the safety of S-equol in healthy volunteers and 2) to~     see how quickly S-equol enters the bloodstream, is distributed in the body, and broken down~     and removed, when taken with food or without food.~   "
211881|NCT00786994|"~     In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a treatment~     period of 3 months will be tested. Additionally, once and twice daily applications are~     tested.~   "
211882|NCT00786981|"~     Lumbar spinal stenosis (LSS) is a prevalent and disabling condition in the rapidly growing~     aging population. People with LSS often have a substantial physical and psychosocial burden~     as well as significant healthcare costs affecting both the individual and society. It has~     been reported that patients with LSS over the age of 65 are more likely to undergo spinal~     surgery than any other condition with an estimated total annual inpatient expense of one~     billion. Individuals undergoing surgical treatment for LSS tend to be older, therefore~     operative morbidity and mortality are a particular concern. Functional benefit derived from~     conservative treatment may increase the health and quality of life for individuals suffering~     from LSS and avoid or delay the need for surgery in some subjects. As the population~     continues to age, identifying effective non-surgical treatment options for older patients~     with LSS is an important research priority. Ultimately, the information gained from this~     study will help fill a significant void in medical literature regarding non-surgical options~     for this patient population.~   "
211883|NCT00786968|"~     This is a one-year extension study of the use of laronidase into the spinal fluid to treat~     spinal cord compression in mucopolysaccharidosis I. Mucopolysaccharidosis I is a rare genetic~     condition due to deficiency of the enzyme alpha-l-iduronidase. Spinal cord compression occurs~     in this condition due to accumulation of material called glycosaminoglycans (GAG). Laronidase~     is the manufactured form of the enzyme alpha-l-iduronidase that is deficient in~     mucopolysaccharidosis I patients. The aim of this study is to determine whether laronidase is~     safe and effective when given into the spinal fluid as a potential non-surgical treatment for~     spinal cord compression due to mucopolysaccharidosis I disease. Funding Source -- FDA OOPD~   "
211884|NCT00786942|"~     The purpose of this study is to determine wether autologous bone graft from iliac crest~     enhances bone union of tibial osteotomies, in the treatment of varus knee deformity.~   "
211885|NCT00786929|"~     The purpose of this study is to evaluate if percutaneous drainage of sterile fluid~     collections recurring after initial aspiration in acute pancreatitis yielded better results~     than their conservative management.~   "
211886|NCT00786916|"~     This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the~     effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term~     deep sedation in children. Patients will be randomized to receive either placebo (saline) or~     one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The~     efficacy of the differing lidocaine doses will be compared to determine the minimum dose~     required to safely achieve alleviation of pain. We hypothesize that premedicating with~     lidocaine will significantly decrease pain experienced by pediatric patients receiving~     propofol for outpatient sedation.~   "
211887|NCT00786903|"~     In critically ill patients Candida spp. are frequently isolated from respiratory tract~     secretions such as endotracheal aspirates and bronchoalveolar lavages (BAL) and are most~     often considered as colonizers of the respiratory tract. In contrast, pneumonia due to~     infection with Candida spp. is rare and is diagnosed by histological demonstration of the~     yeast in lung tissue with associated inflammation. In spite of this, preemptive antifungal~     therapy based on isolation of Candida spp. from the respiratory tract is often initiated in~     critically ill patients. The disadvantages of this approach include increased selective~     pressure for the development of antimicrobial resistance, potential risks of adverse drug~     reactions and high treatment costs. On the other hand, immediate administration of~     appropriate antifungal therapy has been shown to be an important predictor of favorable~     outcome for patients with invasive fungal infections. Therefore, the development of reliable~     diagnostic measures for the detection of invasive pulmonary candidiasis is crucial. The~     overall objective of the proposed research project is to identify diagnostic strategies to~     differentiate between Candida colonization and Candida infection of the lower respiratory~     tract in critically ill patients. The proposed projects intends to test the hypothesis that~     1.) invasive Candida strains from the lower respiratory tract differ from colonizing Candida~     strains with regard to production and expression of putative virulence factors and/or that~     2.) patients suffering from pulmonary invasive candidiasis differ from patients colonized by~     Candida spp. with regard to inflammatory markers, other serum markers (fungal antigen) and~     composition of indigenous pulmonary bacterial flora.~   "
211888|NCT00786890|"~     Hypothesis: A high cardiovascular risk is present in subjects with pre-diabetes in Hong Kong~     Chinese.~      The investigators plan to assess Chinese subjects in Hong Kong who have pre-diabetes~     (impaired fasting glucose, IFG; or impaired glucose tolerance, IGT) based on oral glucose~     tolerance test (OGTT) on their cardiovascular risk status such as obesity, hypertension and~     lipid profile.~   "
211984|NCT00785642|"~     To prove the safety of the gynaecological formulation in normal conditions of use.~   "
227546|NCT00579033|"~     Patients with focal dystonia experience uncontrollable movements of the hand during certain~     types of skilled movements. Though the origin of the disorder is not fully understood, it is~     thought that brain areas involved in moving the hands and receiving touch information from~     the hands, are involved. For example, patients with dystonia affecting the hand show changes~     in their ability to perceive touch - this is something that typically escapes the patients~     own awareness. Further, the area of the brain receiving touch information has a disrupted~     representation of the finger skin surfaces.~      The goal of our research is to improve dystonia symptoms in patients with hand dystonia. We~     will attempt to achieve this goal by implementing an intensive training treatment that~     requires patients to attend to, and use touch information applied to specific fingertips.~     Previous work has attempted to alter touch perception using sensory training and improvements~     in motor control (hand writing) of dystonia patients were observed. For example, learning to~     read Braille improves tactile perception and handwriting in focal hand dystonia. A different~     approach to treat focal hand dystonia involves a technique called repetitive transcranial~     magnetic stimulation (rTMS), and this can also temporarily improve hand writing in dystonia~     patients. The proposed research will attempt to alter touch processing using touch training~     alone, or in combination with rTMS. Rather than train using Braille reading, the sensory~     training will be applied using a systematic, experimenter controlled stimulus set that~     focuses on touch stimuli applied to individual digits. Importantly patients will have to~     associate certain types of touch information with rewards and other touch input with the lack~     of a reward.~      The study will first involve measuring the location and representation of the touch in the~     brain using multiple brain mapping tools. These tools include functional magnetic resonance~     imaging and magnetoencephalography; when both tools are used a very accurate picture of~     finger representation can be obtained, and we also know what brain areas respond to touch~     stimuli. Dystonia symptoms and touch perception will also be assessed. Next, patients will~     participate in a training intervention that involves 15 days(2.5 hr/day) of touch training~     applied to the fingertips of the dystonia affected hand. Patients will identify the touch~     targets amongst distractors and receive on-line performance feedback. The goal of the~     training is to provide the cortex with regular boundaries of fingers and in this way, attempt~     to re-shape the sensory cortex to accept these boundaries. Another group of patients will~     receive rTMS. The goal of the rTMS is to create an environment in sensory cortex that is open~     or 'ready' to accept changes induced by tactile stimulation. The rTMS will be immediately~     followed by the tactile training. A third group of patients will receive a placebo version of~     rTMS followed by tactile training. The latter group will allow us to understand if rTMS has a~     definite effect on the physiology of the patient. Following the 15-day training, we will~     assess the brains representation of fingertips, changes in dystonia symptoms and changes in~     the perception of touch stimuli.~      This research will advance the treatment of focal hand dystonia and assist the design of~     precise remediation training tailored to the dystonia patient.~   "
211889|NCT00786877|"~     At our field site in southern Nepal, acute respiratory illness (ARI) has been a leading cause~     of mortality among young children. Besides immunization there is little evidence for~     effective primary preventive approaches for ARI on a population basis. Low birth weight is~     highly prevalent in this population as well affecting approximately 30% of live born infants.~     Low birth weight is a key determinant of neonatal mortality and has also been resistant to~     cost-effective interventions in resource poor settings. Given the lack of appropriate~     interventions for poor, rural areas in developing countries and the strong observational~     association between open burning of biomass fuel sources and ARI in young children and low~     birth weight, we have designed a community-based randomized trial to determine if reductions~     in household indoor smoke exposure can reduce the incidence and duration of acute lower~     respiratory infections in children <36 months of age and low birthweight among newborn~     infants. Household indoor smoke reduction will be accomplished by replacing the current cook~     stove in the household with a locally appropriate, inexpensive model that is more efficient~     and vented to the exterior. In addition, we will assess the impact on respiratory function~     and symptoms among adults in the household. The project has 2 phases. Phase 1 is a~     cluster-randomized, community-based, step-wedge trial of cookstove replacement in a rural~     population of southern Nepal. Households will be randomized to receive replacement of their~     cook stove with an appropriately designed, efficient stove that is vented to the exterior at~     different time periods during the course of the study. An initial period of surveillance for~     ARI and low birth weight will establish a baseline rate for all clusters. This will be~     followed by the randomized, serial replacements of cook stoves over a 12 month period.~     Surveillance will continue throughout this period and for an additional 6 -18 months~     depending on when the stove was replaced. Phase 2 is a individually randomized trial in a~     subset of households that will receive either the improved biomass stove from phase 1 or a~     LPG stove and gas. Follow-up for phase 2 will be for 12 months with the same outcomes as~     phase 1. Measurement of indoor air particulate concentration will be conducted in all~     households before and after stove replacement. The analysis for both phases will focus on~     estimating the impact on incidence of ARI in children and low birth weight among live births~     as a result of stove replacement. Approximately 4200 children 1-35 months of age will be~     required to observe a minimum 10% reduction in risk of ARI with 90% power in phase 1. Given~     the expected number of live births to occur in these clusters, we can detect a 50 gram~     difference in birthweight with over 90% power and a type I error of 5%. Phase 2 will have~     lower power (total of 1800 households).~   "
211890|NCT00786864|"~     This study aimed to determine the efficacy of an eight-week specific exercise programme in~     reducing self-reported episodes and intensity of LBP, as well as modifying some of the~     identified risk factors for LBP, in children.~   "
211891|NCT00786851|"~     This is a prospective, multicenter phase II trial designed to evaluate the safety and~     activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with~     relapsed/refractory mantle cell lymphoma (MCL).~   "
211892|NCT00786838|"~     The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc~     interval duration measured by electrocardiograms (ECGs) in participants with advanced solid~     tumor malignancies when administered at a therapeutic dose.~   "
211893|NCT00786825|"~     The long-range goal of this project is to determine the effects of diabetes and the~     hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans.~     We will measure brain glycogen turnover and content in normal controls and subjects with~     diabetes under conditions of modest hyper-and hypoglycemia.~   "
211894|NCT00786812|"~     Maintain and monitor long-term hematological and cytogenetic responses previously obtained by~     patients participating in the [CAMN107A2109] study~   "
211895|NCT00786799|"~     Omega-3 fatty acids are among the most commonly used CAM (Complementary Alternative Medical)~     therapies, and have been reported to be currently used by 28.7% of children with autism. Two~     published case series noted that families reported large improvements in the core feature of~     autism when children were given omega-3 fatty acids. Low levels of omega-3 fatty acids have~     been noted in children with autism, which suggests normalizing the omega-3 fatty acid levels~     could produce improvements in the symptoms seen in many children with autism.~      This study is a 12-week randomized, double blind, placebo-controlled clinical trial for 24~     male and female children aged 3 to 8 years with autism. Patients who are currently using~     omega-3 would need to discontinue omega-3 fatty acids for 8 weeks before they are able to~     participate in the study. All study participants who meet all inclusion and no exclusion~     criteria at the initial screening visit and sign the consent form will then complete baseline~     assessments of the outcome measures (validated instruments of hyperactivity, communication,~     social interaction, and behavior) and be randomly assigned to 12 weeks of omega-3 fatty acids~     at a dose of 1 gm per day or an identical placebo. The child's behavior will be measured and~     evaluated at the MIND Institute at the beginning of the study and at study closing. All study~     families will come in for a follow-up visit at weeks 4 and 8 to assess medication compliance~     and side effects to study medication.~      After 12 weeks of treatment, all outcome measures including laboratory tests and side effect~     profiles will be repeated. All patients who complete the study will receive a 12-week supply~     of omega-3. This would also provide patients who were on placebo with active medication. No~     follow-up visits are needed once the patient finishes the double-blind portion of the study.~   "
211896|NCT00786786|"~     Purpose: This project is designed to identify what the key barriers to participating in~     exercise are for the general population of people living with spinal cord injury (SCI) in the~     United States (US).~   "
211897|NCT00786773|"~     To describe the change of impact of reflux symptoms on the everyday life perceived by~     patients before and after 4 weeks treatment by using GERD Impact Scale questionnaire (GIS) by~     total GERD patient population and by treatment group; and to describe the concordance between~     patient-reported and physician-reported symptom load.~   "
211898|NCT00786760|"~     The purpose of this study is to learn about the natural history of Human Papillomavirus (HPV)~     infection in men. The study will also find out what factors are linked to HPV in men~     including other sexually transmitted diseases (STDs). If participants test positive for~     syphilis, gonorrhea or chlamydia, we are required by law to report the results to the Florida~     Department of Health. Participants will be able to get free medical treatment from the~     Florida Department of Health for these STDs. Participants will be given a written report of~     the results of the STD testing.~   "
211899|NCT00786747|"~     The study investigators have developed an interactive multimedia computer program that~     provides personally tailored education about colorectal cancer screening in the user's~     preferred language (English or Spanish). In this study, the investigators will examine~     whether use of the computer program increases the number of Hispanic patients who receive~     colorectal cancer screening and lessens or eliminates the glaring disparity in screening~     between Hispanics and non-Hispanic whites.~   "
211900|NCT00786734|"~     Patients who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without~     pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin~     levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation).~     After PCI, pitavastatin will be administered for additional 4 weeks(2nd evaluation).~   "
211901|NCT00786721|"~     There has been increasing support for our hypothesis that mitochondrial dysfunction plays an~     important role in the etiology of Type 2 Diabetes Mellitus and the overlapping Metabolic~     Syndrome.~   "
211902|NCT00786708|"~     Hypothesis: In patients that present to an urban emergency room, a single urine neutrophil~     gelatinase-associated lipocalin (NGAL) measurement can classify their kidney disease as~     stable chronic kidney disease, acute tubular necrosis, urinary outlet obstruction or~     pre-renal azotemia.~   "
211985|NCT00785629|"~     The purpose of this study is to determine the ability of 3 commercially available phosphorus~     binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and~     maintain a phosphorus level in the normal range in patients with chronic kidney disease.~   "
211903|NCT00786695|"~     Gastroesophageal reflux disease (GERD), with its cardinal symptom, heartburn, is the most~     common disorder of the esophagus in the West. Comparatively, GERD is less common in Singapore~     but its frequency in the population is increasing. Although the vast majority of patients~     with GERD have heartburn and acid regurgitation, GERD can present in atypical ways, including~     as a non-cardiac chest pain (NCCP). We have previously shown that GERD is a common cause of~     NCCP in Singapore. Up to 40% of our patients with NCCP had endoscopic esophagitis, abnormal~     24-hour pH monitoring results, and/or a positive acid perfusion test. These tests, although~     diagnostic, are costly, labour intensive, and not always readily available in the primary~     care setting. A trial of high-dose proton pump inhibitor (e.g. omeprazole 60 mg daily) has~     been proposed as a simple, safe, non-invasive and reliable means to diagnose GERD in Western~     patients with NCCP. We have not used the test routinely in our practice. This study will~     evaluate the use of a short course of esomeprazole, the S-isomer of omeprazole, as a~     diagnostic test for detecting GERD in patients with NCCP. The hypothesis is that in NCCP~     patients with GERD, esomeprazole will resolve their symptoms. Consecutive patients diagnosed~     with NCCP at the National University Hospital, Singapore, will be invited to participate in~     the study. Eligible patients will be randomly assigned to receive either esomeprazole (40 mg~     o d) for 14 days, or comparable dose of placebo at a similar schedule for 14 days, in a~     double-blinded fashion. At the start of the study, all subjects will complete a baseline~     symptom assessment. Symptoms will be scored on a graded scale based on severity. During the~     study weeks, each patient will record his/her own daily symptoms. The patient will be~     assessed again after the 14-day treatment. The primary outcome measure will be the change in~     symptom score after initiation of treatment.~   "
211904|NCT00786682|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Hydroxychloroquine may help docetaxel work better and kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with~     hydroxychloroquine works in treating patients with metastatic prostate cancer.~   "
211905|NCT00786669|"~     The purpose of this research study is to test the safety and of adding bevacizumab to the~     established regimen of vincristine, oral irinotecan, and temozolomide (VOIT) and see what~     effects it has in pediatric patients with relapsed or refractory solid tumors.~   "
211906|NCT00786656|"~     Background:~        -  Studies suggest that cancer patients diagnosed and treated in a facility with~          multi-specialty care and clinical research may live longer and have a better quality of~          life than patients treated elsewhere.~        -  The NCI Community Cancer Centers Pilot Program (NCCCP) is a 3-year program to test the~          concept of a national network of community cancer centers to expand cancer research and~          deliver the most advanced cancer care to Americans in their own communities.~        -  The pilot program includes a survey of cancer patients receiving care at the pilot~          sites.~      Objectives:~        -  To gain an understanding of the experiences of adult patients who receive services at~          the NCCCP pilot sites and assess if and how their experience changes over the study~          period. Data about the following are collected:~        -  Patients information needs and awareness of the NCCCP program~        -  Clinical trials experience~        -  Access to health care~        -  Perspectives on patient-provider communication~        -  Experiences with patient navigation, self-management, medical decision-making and~          survivorship~        -  Satisfaction with care and quality of life~      Eligibility:~        -  Patients 21 years or older at the time of diagnosis~        -  Treatment at the cancer center for at least 3 months since July 1, 2007~      Design:~        -  Participants complete a 25-minute questionnaire covering the care they received at their~          cancer center, their experience with making medical appointments and how long they~          waited to see the doctor. The survey includes information on the following:~        -  Services at the cancer center~        -  Getting needed care~        -  Assistance for patients and their families~        -  Communication with the cancer care team~        -  Clinical trials~        -  Care after finishing treatment~        -  Evaluation of care~        -  Health and medical history~        -  Background information (demographics)~   "
211907|NCT00786643|"~     The purpose of this study is to evalute the response and toxicity of metastatic colorectal~     cancer patients to the regimen of gamma interferon added to bolus and infusional~     5-fluorouracil and leucovorin (GFL) with or without bevacizumab.~   "
211908|NCT00786630|"~     This is a five-year prospective randomized trial comparing two intervention conditions~     designed to facilitate substance abuse treatment entry and enhance retention in order to~     reduce the behaviors associated with HIV and HCV risk among injection drug users (IDUs) and~     to improve client overall functioning. The overall goal of this project is to compare~     strengths-based case-management (CM) to an enhanced version of CM that uses case managers to~     facilitate a therapeutic alliance (CM/FTA) among out-of-treatment IDUs in Denver.~   "
211909|NCT00786617|"~     1. Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will~          have a mean length of stay on ventilator at least one day shorter than patients weaned~          by physician-initiated, non-protocol methods~        2. Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will~          have al least similar Ventilator, ICU, and Hospital Length Of Stay (LOS) compared to~          patients weaned by physician-initiated, non-protocol method~        3. Nurse-driven ventilator weaning protocol is well accepted by other services: physicians,~          nurses, and respiratory therapists.~   "
211910|NCT00786604|"~     The purpose of this research study is to find out how blood sugar levels change during the~     day and night in people living with spinal cord injuries (SCI) and then to compare that with~     people who do not have a spinal cord injury.~      As people with SCI get older they become more likely to develop health problems, just like~     everyone else. However, SCI increases the risk of certain problems. The amount of time~     post-SCI can also increase the risk of certain problems. This research project will focus on~     identifying the patterns of changes in blood sugar levels after SCI. Sugar in the blood is~     the important source of energy for the body. Too much sugar in the blood is known as~     hyperglycemia and not enough sugar in the blood is known as hypoglycemia. Under healthy~     conditions, the amount of sugar in the blood is automatically regulated so that a steady~     level is maintained. After SCI, however, this automatic regulation is damaged. The likelihood~     of experiencing too much or too little blood sugar is increased. Over time, having too much~     blood sugar can lead to the development of diabetes. In just the opposite situation,~     individuals with SCI can begin to experience more frequent episodes of too little blood~     sugar, which can lead to acute emergency situations.~      The pattern of how blood sugar levels change during a typical 24-hour time period in persons~     with SCI is not known. There may be unknown factors that affect blood sugar levels. In order~     to find out that information, this study will involve continuously monitoring blood sugar~     over a 3-day period in a variety of persons with SCI. A non-invasive, wireless monitoring~     system will be attached to the abdomen. This system records blood sugar levels every 5~     minutes. The information gathered from this observational study is vital to the understanding~     of how SCI alters the regulation of sugar levels in the blood and to the subsequent medical~     management of this population.~   "
211911|NCT00786591|"~     Acute pancreatitis refers to inflammation of the pancreas and is associated with sudden onset~     of severe abdominal pain, often accompanied by transient systemic manifestations, including~     fever. In the majority of cases, the inflammatory process is self limiting and patient~     recovers uneventfully; however, in about 20% to 30% of the cases, a protracted clinical~     course ensues and the disease may progress to a severe necrotizing form, often triggering a~     systemic inflammatory response syndrome during which time, acute respiratory distress~     syndrome, renal failure, shock, and disseminated intravascular coagulation may occur. In the~     worst sequelae, multiple organ dysfunctions may follow and death supervene. The clinical~     outcome of patients suffering from severe acute pancreatitis depends to a great extent on the~     early diagnosis and prediction of severity and timely therapeutic intervention to prevent~     local and systemic complications. However, the course of the disease is often difficult to~     predict from the outset. Currently, there is still no single clinical or laboratory test that~     can be considered the gold standard for diagnosis and/or assessment of severity of acute~     pancreatitis. For a disease that may progress rapidly without apparent sign, the ideal marker~     for the prediction of disease severity in a patient would be one that is measurable rapidly~     and easily, besides being able to fulfill all the other criteria required of a good~     biological marker. To identify such a potential marker for acute pancreatitis requires~     understanding of the pathophysiological process underlying the rapid progression of a~     fulminant course of the disease. Although much remains to be elucidated, recent studies in~     animals have suggested that inflammatory mediators substance P and hydrogen sulfide may play~     critical roles. This study will evaluate if inflammatory mediators substance P and hydrogen~     sulfide are upregulated early on in the disease process, and if the levels of their elevation~     predict disease severity.~   "
211912|NCT00786578|"~     Type 2 diabetes is a growing public health issue and one component of Type 2 diabetes is~     'insulin resistance - the ability of insulin to work less well. The skeletal muscle is one~     of the largest users of sugar in the body, when the skeletal muscle is insulin resistant,~     this contributes to diabetes. There is some evidence that the amount of fat in the skeletal~     muscle is related to the amount of insulin resistance. We are asking people to participate in~     a study to look at the amount of fat in muscle and how this fat amount changes with exercise.~     We hypothesize that heavier people will have higher amounts of fat and deplete this fat more~     slowly than lean subjects.~   "
211913|NCT00786565|"~     This study evaluates the visual performance and occurrence of posterior capsular~     opacification after implantation of a new aspherical intraocular lens compared with a control~     spherical lens of otherwise identical design.~   "
211914|NCT00786552|"~     The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed +~     paclitaxel in patients with recurrent/advanced follicular, papillary or anaplastic thyroid~     cancer.~   "
211915|NCT00786539|"~     The objective of this research protocol is to continue investigation of the nature and~     prevalence of mitochondria disease and to aid patients and health care providers in the~     understanding of these complex disorders.~      This research study brings together many clinical sub-specialists to address the etiology of~     these disorders and to develop more effective approaches for their diagnoses and more~     reliable prognoses.~   "
211916|NCT00786526|"~     Animal studies showed that controlled mechanical ventilation (CMV) can induce dysfunction of~     the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic~     force-generating capacity, called ventilator-induced diaphragmatic dysfunction (VIDD).~   "
211917|NCT00786513|"~     The purpose of this study is to determine whether choosing antibiotics based on a biofilm~     antimicrobial susceptibility assay rather than a conventional planktonic antimicrobial~     susceptibility assay to treat CF patients with chronic P. aeruginosa infection with an acute~     pulmonary exacerbation is a safe intervention that will result in improved microbiological~     and clinical outcomes and decrease markers of pulmonary inflammation.~   "
211918|NCT00786500|"~     The aim of the present study was to investigate the long-term effects on blood glucose~     concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP).~     This is a plant growing in the mountain regions of Northern Vietnam and previously being used~     in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed~     patients with type 2 diabetes and administered as a tea, 3 g two times daily during 12~     weeks. All patients received instructions regarding diet and physical exercise. Oral glucose~     tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken~     with the purpose to monitor lipids, kidney and liver function, body weight and blood~     pressure.~   "
211919|NCT00786487|"~     We are interested in how skeletal muscle processes fat and how this may affect insulin~     resistance. This is an important question since insulin resistance predates and predicts type~     2 diabetes. We know that if pharmaceutical grade fat is infused into people, they develop~     insulin resistance. Likewise, we would like to infuse pharmaceutical grade fat into trained~     subjects, believing that trained subjects will have less insulin resistance, less decline in~     muscle energy function, and less accumulation of fat metabolites than untrained subjects. For~     comparing the effects of the pharmaceutical grade fat infusion, we will also have a group of~     trained and untrained subjects given a control (glycerol) infusion. Glycerol is basically the~     same as pharmaceutical grade fat infusion without the fat component.~   "
211920|NCT00786474|"~     Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk~     of a stroke or heart attack. When people undergo surgery or certain procedures, they must~     stop using warfarin to prevent too much bleeding during and after the surgery or procedure.~     Some doctors prescribe a different blood thinner, one that works more quickly and wears off~     more quickly, to bridge the gap between starting and stopping warfarin. However, this~     short-term treatment is expensive, may increase the risk of bleeding, and has not been proven~     effective. This study will determine whether a bridging blood thinner called dalteparin is~     helpful or harmful for people with atrial fibrillation who stop taking warfarin in~     preparation for surgery or a procedure.~   "
211921|NCT00786461|"~     Silver nitrate treatment of Bartholin's cyst or abscess will be compared to marsupialization~     treatment.~      It is expected that silver nitrate treatment is effective, simple, inexpensive and the least~     anaesthetic requiring procedure, which can easily be carried out in the outpatient setting.~   "
211922|NCT00786448|"~     - Data are obtained of Emselex in routine treatment of Overactive Bladder. The general~     objectives are to evaluate the product safety, compatibility, efficacy and patient~     acceptance.~   "
211923|NCT00786435|"~     As people with spinal cord injuries (SCI) get older they become more likely to develop health~     problems, just like everyone else. However, SCI increases the risk of certain problems. This~     research project will focus on the control of blood sugar after SCI. Sugar in the blood is~     the important source of energy for the body. Too much sugar in the blood is known as~     hyperglycemia and not enough sugar in the blood is known as hypoglycemia. Under healthy~     conditions, the amount of sugar in the blood is automatically regulated so that a steady~     level is maintained. After SCI, however, this automatic regulation is damaged. The likelihood~     of experiencing too much or too little blood sugar is increased. Over time, having too much~     blood sugar can lead to the development of diabetes. In just the opposite situation,~     individuals with SCI can begin to experience more frequent episodes of too little blood~     sugar. It is thought that the level of SCI, amount of time post-injury, and amount of body~     fat are important factors in the development of hyperglycemia or hypoglycemia. This study~     will test 2 of those factors, level of SCI and amount of body fat. A total of 35 subjects~     will be enrolled, 24 with SCI and 11 able-bodied controls. All procedures will be performed~     at the university's clinical research center. Susceptibility to hyperglycemia will be tested~     by having each subject drink a sugar water solution and then taking blood samples every 30~     minutes for 2 hours. Hypoglycemia will be tested by very carefully inducing low blood sugar,~     taking blood samples over a 2 hour time period to evaluate different chemicals, and answering~     a questionnaire about different symptoms experienced during the procedure. Body fat will be~     measured by having a special kind of x-ray. It is predicted that subjects with cervical~     injuries and with more body fat will be at the greatest risk of experiencing hyperglycemia~     and hypoglycemia. The results from this study will provide important information for future~     studies aimed at examining the effect of exercise and other potentially therapeutic agents on~     blood sugar regulation in the aging SCI population.~   "
211924|NCT00786422|"~     This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in~     patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who~     concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire~     3-month study duration.~   "
211925|NCT00786409|"~     The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine~     Gardasil in young women.~   "
211926|NCT00786396|"~     The aim of this study is to develop effective interventions for HIV-infected prisoners who~     are released to the community. The intervention that we will study will be directly observed~     therapy (DAART/DOT) and we will compare this to the current standard of care that involves~     self-administered therapy (SAT). All subjects will get transitional case management and all~     subjects with a prior history of opiate dependence will be offered opiate substitution~     therapy (buprenorphine or methadone).~      Hypotheses:~        -  At the end of six months those receiving DAART will have a higher level of adherence to~          HAART as compared to the SAT group.~        -  The DAART Intervention will result in subjects having lower viral loads and higher CD4~          counts as compared to the SAT group.~        -  At the end of six months, the DAART group will have a lower rate of recidivism to~          jail/prison as compared to the SAT group.~        -  Over the year, the DAART group will be more likely to make repeated primary HIV care~          visits than the SAT group.~   "
211927|NCT00786383|"~     We are conducting a research study for tumors that have not responded to prior treatment. The~     subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of~     IMC-1121B, is running this research study.~      We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood~     vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor~     will not get the oxygen and food that it needs to grow. This may stop the cancer from growing~     or spreading and the tumor cells may die. Since normal blood vessels have already formed in~     adults, it might be possible to stop tumor growth without harming normal cells.~   "
211928|NCT00786370|"~     The use of dexmedetomidine in cataract surgery is still limited and to date only one study~     has examined anesthetic technique in this patient population. This pilot study will therefore~     compare the use of dexmedetomidine and propofol in subjects undergoing cataract surgery. The~     primary endpoint will be based on simple cardiorespiratory measures often associated with~     complications from sedation as well as assessment of the achieved sedation by the attending~     anesthesiologist and surgeon.~   "
211929|NCT00786357|"~     The purpose of this study is to determine if a modified version of the Sleep Enhancement~     Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and~     quality of life in experienced shift-working nurses.~   "
211930|NCT00786344|"~     The purpose of this study is to learn how activity promotes health and well being among older~     adults. There are two main study goals: (1) to extend the previous results obtained for the~     Well Elderly Study 1; and (2) to determine what factors make the program successful.~   "
211931|NCT00786331|"~     The aim of this study is to compare time to progression between the combination~     pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally~     advanced or metastatic NSCLC.~   "
211932|NCT00786318|"~     The primary objective is to determine if ziprasidone is superior to standard therapies in the~     emergency department treatment of the acutely agitated patient. The primary outcome will be~     the length of time taken until the patient is ready to be evaluated by the psychiatric~     service, or until a disposition is made.~   "
211933|NCT00786305|"~     Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated~     pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics~     delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung~     bacterial killing. The aim of the study is to assess the efficiency of nebulized ceftazidime~     and amikacin in the treatment of pneumonia caused by Pseudomonas aeruginosa in ventilated~     patients.~   "
211934|NCT00786292|"~     Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to~     improve the respiratory function in experimental acute lung injury (ALI). We aimed at~     comparing the effects of noisy PSV with traditional PSV on the respiratory function of~     patients suffering from ALI.~   "
211935|NCT00786279|"~     We propose a pilot study to determine the feasibility of a long-term clinical trial of~     alcohol intake on atherosclerosis, the first step in determining whether moderate drinking~     prevents cardiovascular disease and hence in understanding the full health effects of alcohol~     across the population. We will randomize 40 participants aged 55 and older to a six-month~     period of consumption of 1 glass per day of either pure alcohol (diluted to the strength of~     wine) or water. At baseline and after 6 months, we will measure several standard and novel~     cardiovascular risk markers in the blood and will perform magnetic resonance imaging to~     measure atherosclerosis of the aorta.~   "
211936|NCT00786266|"~     The purpose of this study is to determine if a modified version of the Sleep Enhancement~     Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and~     quality of life in shiftwork-naive new nurse graduates.~   "
211937|NCT00786253|"~     Compare once daily vs on demand treatment in men with erectile dysfunction.~      Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks +~     4 weeks wash-out:~      A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at~     bedtime for 24 weeksC: PRN for 24 weeks~   "
211938|NCT00786240|"~     The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D~     and formulation E(1).~   "
211939|NCT00786227|"~     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap~     initiative to develop a computerized system measuring patient-reported outcomes in~     respondents with a wide range of chronic diseases and demographic characteristics. In the~     first four years of its existence, the PROMIS network developed item banks for measuring~     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical~     function, and social functioning. During the item banking process, the PROMIS network~     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses~     to refine the meaning, clarity, and literacy demands of all items. The item banks were~     administered to over 20,000 respondents and calibrated using models based on item response~     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were~     developed and implemented. The network has designed a series of studies using clinical~     populations to evaluate the item attributes, examine their utility as CATs, and validate the~     item banks. More information on the PROMIS network can be found at www.nihpromis.org.~   "
212126|NCT00783757|"~     The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast~     Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast~     cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in~     breast tissue.~   "
211941|NCT00786201|"~     The experimental drug CNTO 888 is currently being studied in cancer patients with solid~     tumors and this study is the first to use this drug for patients with idiopathic pulmonary~     fibrosis (IPF). This study tests the safety and effectiveness of CNTO 888 compared to~     placebo. The purpose of this research study is to determine if CNTO 888 is safe and to~     determine its effects (good and bad) on patients with IPF. The study will be conducted at~     approximately 28 sites globally. Patients can remain on usual, accepted treatment for IPF~     while enrolled in the study. Participating in other experimental studies or taking other~     experimental medications while participating in this study will not be allowed.~   "
211942|NCT00786188|"~     This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled~     study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe~     postmenopausal vasomotor symptoms (VMS), defined as follows:~        -  Moderate VMS: Sensation of heat with sweating, able to continue activity~        -  Severe VMS: Sensation of heat with sweating, causing cessation of activity~   "
211943|NCT00786175|"~     Hypothesis: there is a high prevalence rate of diabetes, including asymptomatic undiagnosed~     glucose intolerance, among subjects with coronary heart disease in Hong Kong.~      A cross-sectional survey is planned to study the rate of undiagnosed diabetes and glucose~     intolerance among the Chinese patients with coronary heart disease in Hong Kong. The survey~     results will be important for us to plan the logistics to investigate and manage the~     potential glucose abnormality of our heart disease patient.~   "
211944|NCT00786162|"~     The specific aim of the study is to assess the impact of an Internet-enabled, automated,~     self-management program on blood pressure control of employees of a large local company.~   "
211945|NCT00786149|"~     the purpose of the study is to see if varenicline in combination with motivational counseling~     helps homeless cigarette smokers quit smoking.~   "
211946|NCT00786136|"~     The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased~     steadily in recent years. This has resulted in the increasing incidence of contrast-induced~     acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes~     mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs,~     hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning~     that in a patient with CKD it amplifies the risk of CIAKI.~      The aim of this multicenter prospective, randomized, controlled study is to evaluate whether~     statins treatment during the perioperative period would reduce the risk of CIAKI in a~     high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing~     coronary angiography or noncoronary angiography, and evaluate the influence of such potential~     benefit on short-term outcome.~   "
211947|NCT00786123|"~     Irritable bowel syndrome (IBS) is a very common chronic gastrointestinal disorder. Existing~     therapies for IBS are still far from satisfactory and new therapies are being constantly~     sought. Probiotics are promising candidate for the prevention and treatment of IBS. However,~     its efficacy and mechanism is still unclear. The current study aims to evaluate the effects~     of a combination probiotic, VSL#3, on symptoms and rectal sensitivity in patients with IBS.~     The underlying mechanism will also be investigated. We will recruit forty patients with Rome~     III IBS and randomized them, in a parallel group, double-blinded design, to take four VSL#3~     capsules or placebos, twice daily, for six weeks. Before and after treatment, patients will~     be assessed for their symptoms, rectal sensitivity, as well as saliva and fecal melatonin~     levels. Bowel symptom diary and weekly satisfactory relief of bowel symptoms will also be~     recorded and evaluated.~   "
211948|NCT00786110|"~     The study is designed as a Phase II, prospective, non randomized, open-label, single arm,~     multicenter trial, in which patients with locally advanced or metastatic ACC not amenable to~     complete surgical resection and progressing to cytotoxic chemotherapy will receive Sorafenib~     plus metronomic chemotherapy as treatment.The aim of this phase II trial is to evaluate the~     clinical benefit and toxicity of the combination of Sorafenib plus metronomic chemotherapy in~     patients with locally advanced or metastatic ACC who progressed after first or second line~     chemotherapy.~   "
211949|NCT00786097|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the~     product Dermacyd PHDETINLYN Tangerine Mix.None.~   "
211950|NCT00786084|"~     In 2006 this research group reported their initial findings of a multi-center prospective~     trial comparing primary repair and primary repair buttressed with a biologic mesh made from~     porcine small intestinal submucosa (SIS). We were able to accrue 108 patients from~     7/2002-3/2005 and followed each patient over 6 months and performed an UGI to check the~     durability of the repair and rule out a recurrence. The results suggested a significant~     benefit for the use of SIS mesh in the short-term, with the primary group having a 26%~     recurrence rate and the mesh group a 9% recurrence rate.~      While these results are encouraging, it is important to know what is the durability and the~     longer term benefits of the use of SIS mesh. For this reason we propose a follow-up of the~     original study patients with the same outcome measures (symptom questionnaire, SF-36, and~     UGI). This should give us a very good idea about the long-term success of laparoscopic PEH~     repair with primary and SIS mesh.~   "
211951|NCT00786071|"~     Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good~     appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The~     pathological mechanism is barely understood. Although feeding difficulties may play a part in~     this, other constitutional factors as altered metabolic processes are suspected. Irregular~     breathing is a common clinical feature, reflecting the immaturity of the brainstem in RTT.~     The primary pathophysiology is a defective control mechanism of carbon dioxide exhalation~     that leads to chronic respiratory alkalosis or acidosis. We assume that chronic respiratory~     acidosis or alkalosis causes derangement of the metabolic equilibrium in RTT females with~     important nutritional consequences.~      The aims of this pilot study are to describe the nutritional status of the RTT girls and to~     examine the consequences of a chronic respiratory acidosis or alkalosis on metabolic~     processes as a possible cause of impaired nutritional status.~   "
211952|NCT00786058|"~     The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/~     5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.~   "
227547|NCT00579020|"~     The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and~     effective in treating marginal corneal infiltrates.~   "
211953|NCT00786045|"~     The objective of this study is to evaluate, among persons who have completed the restorative~     phase of stroke and have ceased rehabilitation, the relative effectiveness in improving~     functional exercise capacity of two programs for continued care, a home-based general fitness~     training program using stationary cycling and a disability targeted, home-based exercise~     program to enhance mobility and walking competency. capacity compared with the walking~     group and that consequently the cycle group will achieve a higher quality of life.~      A secondary objective is to explore factors associated with compliance with the exercise~     regimens. Previous research has indicated that cognitive-affective-behavioural profile is~     related to exercise activity in a number of populations including sedentary adults, older~     adults and patients with cardiovascular disease. As we anticipate that one of the mechanisms~     by which the cycling will result in an outcome better than the more traditional type of~     disability tailored exercise program is through greater compliance, this second objective is~     very relevant. This study will also address the impact of regular exercise on cardio-vascular~     risk factor profile.~   "
211954|NCT00786032|"~     The goal of this VA demonstration project is to show that the Brain-computer interface (BCI)~     technology is a clinically practical and important new communication and control option that~     can improve the lives of veterans with amyotrophic lateral sclerosis (ALS). The project will~     test four well-supported hypotheses: (1) that people with ALS who find (or will soon find)~     conventional assistive technology inadequate can and will use a BCI system for important~     purposes in their daily lives without close technical oversight, 2) they will continue and~     even increase this use throughout the period of the study, (3) that BCI use will improve~     their lives, and 4) BCI will improve the lives of their families and caregivers.~   "
211955|NCT00786019|"~     This study will evaluate the effects of impaired blood flow regulation on exercise. It will~     also determine whether the effects are more important in the heart or in the skeletal muscle~     tissue during exercise. In addition, this study will decide whether temporarily reversing~     these problems will improve blood flow control, improve heart and muscle tissue function and~     help improve exercise capacity in person with type 2 diabetes. This study will do so using~     two methods: (1) by giving vitamin C intravenously (IV) and (2) a three month exercise~     training program. Up to 100 subjects will be enrolled in this study.~   "
211956|NCT00786006|"~     The investigators are to evaluate the efficacy and safety of FOLFOX or FOLFIRI.3 combination~     chemotherapy as second-line salvage chemotherapy in patients with advanced pancreatic~     carcinoma.~   "
211957|NCT00785993|"~     Egg-banking would considerably simplify the logistics and means by which oocytes could be~     donated. These banks would make it easier to immediately provide oocytes that would be~     compatible to the recipient, shortening or even eliminating the problem of long waiting~     lists. Egg-banking would also allow the oocytes to be effectively quarantined, drastically~     diminishing the risk of transmission of infectious diseases in a fashion analogous to semen~     banks. The most essential prerequisite for a successful egg cryo-banking program is to have~     an efficient oocyte cryopreservation technology. Recent studies, including our own~     experience, have indicated that vitrified oocytes preserve intact their potential to~     fertilize and further develop into competent embryos, giving high clinical results as well as~     high survival rates. The aim of this study is to evaluate impact of the establishment of an~     egg-banking in our ovum donation program. Oocyte cryopreservation is carried out by Cryotop~     method. The study includes oocyte donation cycles conducted with fresh and vitrified oocytes.~     Recipients are allocated randomly into each group (fresh vs. vitrified cycles). Main~     outcome measures include survival, fertilization, embryo development and clinical outcome.~   "
211958|NCT00785980|"~     Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes~     responsible for the metabolism of quinine. This study will evaluate the effect of~     ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate.~   "
211959|NCT00785967|"~     Hypothesis: Treatment with raltegravir does not alter V(D)J recombination or immune responses~     to neoantigens.~      A process known as V(D)J recombination is essential for developing lymphocytes and the~     specific functioning of the immune system. Raltegravir is the first approved drug of the new~     integrase inhibitor class of anti-HIV drugs. Integrase inhibitors have been shown in some~     studies to interfere with DNA cleavage and the activities of RAG-1/2. These studies suggest a~     potential to affect aspects of both B-cell and T-cell development, therefore, it is important~     to evaluate the potential effects that integrase inhibitors may have in clinical use. If~     immunoglobulin and T-cell receptor genes are altered by HIV integrase, then patient~     lymphocytes will fail to display normal responses to vaccinations.~   "
211960|NCT00785954|"~     The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing~     infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a~     percutaneous coronary intervention (PCI). A select number of sites will also participate in a~     substudy where eligible patients will undergo an additional procedure;cardiac magnetic~     resonance imaging.~   "
211961|NCT00785941|"~     The purpose of this study is to determine if IMC-A12 is safe for patients, and also to~     determine the best dose of IMC-A12 to give to patients.~   "
211962|NCT00785928|"~     To assess the efficacy of LY2127399 versus placebo using ACR50 response scale at 24 weeks~   "
211963|NCT00785915|"~     This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending~     dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male~     and female Japanese and Caucasian subjects~   "
211964|NCT00785902|"~     ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate~     the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial~     fibrillation during concomitant on-pump cardiac surgery.~   "
211965|NCT00785889|"~     Compared with the conventional (air) method, patients examined by the study (water) method~     have lower pain scores and require less medication but have similar cecal intubation rate and~     willingness to repeat future colonoscopy.~   "
211986|NCT00785616|"~     This study will enroll completers of a prior 24 week MEMS cap study of Kaletra adherence,~     conducted in 2005 - 2006, and repeat the MEMS monitoring for an additional 24 weeks in~     2008/2009 on the current antiretroviral anchor drug. The goals of the study are to correlate~     long-term adherence with virologic outcome, and to explore the stability of MEMS cap~     adherence measurements over time.~   "
211966|NCT00785876|"~     Ankle injuries are a very common injury in children. Each year approximately 35000 kids~     present to Ontario emergency departments (ED) with this problem. Right now, about 90% of~     these children get x-rays of the injured ankle, even though only 12% of these x-rays show a~     break in the bone. Some excellent research has created some rules that doctors can use to~     help them decide which children really need x-rays. Unfortunately, even though these rules~     have been proven to safely reduce x-rays by as much as two-thirds, most doctors are not using~     these rules.~      Therefore, this study will be the first to put the best paediatric ankle x-ray rule, the Low~     Rick Ankle Rule, into physician practice in EDs. Our main goal is to determine how much we~     can reduce ankle x-ray rates in EDs that use this rule regularly versus those that do not. If~     we show that doctors can safely use this rule regularly and the number of ankle x-rays will~     be significantly less, this will lessen unnecessary potentially harmful radiation exposure in~     children, these children will spend less time in an ED, and the health care system will save~     money.~   "
211967|NCT00785863|"~     In addition to alleviate pain there is growing evidence that µ-opioids enhance pain. This~     problem is known as opioid induced hyperalgesia(OIH).The NMDA receptor is involved in opioid~     induced hyperalgesia it may be possible to block OIH by cyclooxygenase inhibitors. This has~     been demonstrated with parecoxib, a COX-II inhibitor, in a experimental pain model.Both COX-1~     and COX-2 are expressed in the spinal cord. It would be of interest to investigate whether a~     COX-1 preferring inhibitor like ketorolac also can reduce opioid induced hyperalgesic in this~     experimental pain model.~   "
211968|NCT00785850|"~     To prove the safety in normal conditions of use.~   "
211969|NCT00785837|"~     Researchers suggest that the protection of the cycles of sleep is essential for~     neurodevelopment, learning, memory and preservation of brain plasticity to the individual's~     life. Recent research shows that technical bath promote reduction of crying, anxiety and~     improves the behavior of newborns.~   "
211970|NCT00785824|"~     The primary aim of this study is to obtain measures of amino-terminal telopeptides of~     procollagen 1 (P1NP), a marker of bone formation, in lactating and non-lactating post-partum~     African-American women both at 6-8 and at 12-14 weeks post-partum, and to compare these~     values to those of normal controls. The secondary aim is to obtain at the same time points,~     measurements of Parathyroid Hormone-related Protein (PTHrP), additional markers of bone~     turnover [e.g. N-telopeptide of collagen cross-links (NTx), C-telopeptide of collagen~     cross-links (Ctx),bone specific alkaline phosphatase (BSAP) and osteocalcin (OC)], calcium~     and vitamin D metabolism in these subjects. These results will be compared with a~     non-African-American cohort of post-partum women and normal controls.~      The investigators hypothesize that African-American lactating women will have increased bone~     turnover when compared to non-lactating postpartum women and normal controls. The~     investigators further hypothesize that bone turnover is increased in lactating women~     independent of race.~   "
211971|NCT00785811|"~     The primary purpose of this study is to evaluate the effect of oral administration of~     L-arginine in the muscular fatigue of the quadriceps, expressed in terms of the Fatigue~     Resistance Factor (FRF). The secondary purpose of this study is to evaluate the effect of~     oral administration of L-arginine in the muscular force the quadriceps.~   "
211972|NCT00785798|"~     The study will be a dose-finding, phase I study of the combination of vorinostat and PLD in~     patients with advanced lymphoma refractory to at least one prior systemic therapy. The study~     will also be a dose-escalating study of vorinostat 200mg to 400 mg twice daily for 7 days~     with PLD 30mg/m2 on day 3 every 21 days, with intrapatient dose escalation.~   "
211973|NCT00785785|"~     This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients~     with unresectable or metastatic gastrointestinal stromal tumors (GIST).~   "
211974|NCT00785772|"~     The primary objectives of this study are to evaluate the pharmacokinetics (PK) following~     administration of gabapentin in Japanese epileptic patients with renal impairment to confirm~     if there are any clinically relevant differences between the plasma gabapentin concentration~     simulated by population PK model, which was used for the evidence of the dose adjustment for~     the patients with renal impairment, and observed plasma gabapentin concentration.~   "
211975|NCT00785759|"~     Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects with Probable~     Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers.~   "
211976|NCT00785746|"~     The objective of this pilot study is to estimate, for a frail elderly population, the extent~     to which balance improves following a Core-Strength training program in comparison to a~     Stretch & Strength program. A secondary objective is to explore the impact of core strength~     training on urinary incontinence.~   "
211977|NCT00785733|"~     The primary objective of this non-interventional study is to evaluate efficacy of Symbicort®~     SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6~     months period~   "
211978|NCT00785720|"~     The purpose of this study is to demonstrate the absence of photoirritation and~     photosensitization potential of the product Dermacyd PHDETINBACK Sweet Flower.~   "
211979|NCT00785707|"~     The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory~     behavior in children during the first two (hearing) years. The questionnaire has been~     validated on children with normal hearing whose native language is German. A comparison was~     made between North American English speaking children with normal hearing and found that it~     was consistent with the German data. This study is to validate the questionnaire in children~     with cochlear implants.~   "
211980|NCT00785694|"~     This is a randomised, comparative, multicentre study to determine if the early recurrence~     rate of intermediate-risk bladder cancer is similar in subjects treated with multiple~     instillations of mitomycin C after resection conducted under white light cystoscopy (group A)~     and subjects treated with 1 instillation of mitomycin C after resection conducted under white~     light and blue light cystoscopy (group B).~   "
211981|NCT00785681|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of~     the product Dermacyd PHDETINBACK Sweet Flower.~   "
212127|NCT00783744|"~     To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin~     versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of~     change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus~     glimepiride and metformin.~   "
211987|NCT00785603|"~     The purpose of the study is to examine the connection between the dose of paroxetine and the~     effect of paroxetine on tramadols metabolism and thereby the effect of tramadol on the median~     pupil size.~      In the study 12 healthy volunteers are going through 5 phases where they are suppose to~     consume a determined dose of tramadol and 5 various doses of paroxetine corresponding to the~     5 phases. Fig 1.~      phases 1 2 3 4 5 Dosis Tramadol mg 50 50 50 50 50 Dosis Paroxetine mg Placebo 10 20 30 50~     Paroxetin / placebo 2 ½ placebo 2 placebo 1 ½ placebo 1 placebo tablets ½ paroxetine 1~     paroxetine 1 ½ paroxetine 2 ½ paroxetine Fig. 1 summary of the 5 phases~      There is a variation in the time where maximal plasma concentration is obtained in~     consumption of respectively tramadol (1 - 2 hours) and paroxetine (6 hours). For that reason~     there has to be at least 6 hours between the administration of paroxetine and tramadol.~      The healthy volunteer brings the research medicine home and consumes it before bedtime the~     night before the day of the study. At eight o'clock next morning the healthy volunteer~     arrives to the first pupil measurement and consumption of tramadol. Tree hours later the next~     pupil measurement is carried through. The healthy volunteer accumulates his or her urine~     until 2 pm. As paroxetine is a irreversible inhibitor of the enzyme CYP2D6 there has to go at~     least 14 days before the next phase takes place. In that amount of time there can be~     recreated a new pool of enzyme.~   "
211988|NCT00785590|"~     To demonstrate the absence of photoirritation and photosensitization potential of the product~     Dermacyd PHDETINLYN Sweet Flower.~   "
211989|NCT00785577|"~     The purpose of this study is to test whether a new treatment will be safe and effective in~     treating pain. Patients with diabetic peripheral neuropathy will be included.~   "
211990|NCT00785564|"~     A consequence of chronic RV pacing is a process of electrical remodeling that alters~     myocardial repolarization to reflect the altered depolarization induced by the RV lead. When~     RV pacing is discontinued, the altered repolarization persists for several weeks. This~     phenomena is traditionally described as T-wave memory based upon the 12-lead ECG appearance~     of inverted T-Waves. The investigators are using the ECGI technique to produce three~     dimensional electroanatomical images of this phenomena in patients with dual chamber~     pacemakers. Echocardiography will also be used to image the mechanical effects of RV pacing~     and T-wave memory. The images will show the spatial distribution of altered repolarization~     and allow us to correlate any mechanical consequences of this phenomena that may exist.~   "
211991|NCT00785551|"~     The effects of mild or moderate renal impairment (creatinine clearance 30 to 50 ml/min or >50~     to 80 ml/min, respectively) on the pharmacokinetic profile of quinine and its active~     metabolite, 3'-hydroxyquinine, will be investigated. Safety and tolerability in healthy~     subjects versus those with mild to moderate renal impairment will be compared, as well.~   "
211992|NCT00785538|"~     The purpose of this study is to determine if IMC-A12 is safe for patients, and also to~     determine the best dose of IMC-A12 to give to patients.~   "
211993|NCT00785525|"~     The purpose of the study is to:~        -  Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood~          stem cells from National Marrow Donor Program donors (NMDP) donors~        -  Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis~        -  Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor~          hematopoietic stem cell transplant recipients~        -  Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in~          normal donors~   "
211994|NCT00785512|"~     This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with~     stage 1 or stage 2 hypertension after the withdrawal of active medication.~   "
211995|NCT00785499|"~     Milk contains a vast number of bioactive components that have been suggested to have a~     positive impact on human health, of special interest is the effects related to metabolic~     syndrome and obesity but the effect of the individual milk components is not clear. This~     study examine whether it is beneficial for overweight and obese children to increase the~     intake of skim milk, or whey or casein in relation to bodyweight and markers of MS.~      The participants will be randomized to receive skim milk, whey milk drink, casein milk drink~     or mineral water for 3 mo. They will be examined at baseline, end of intervention and~     followed up 3 month later.~   "
211996|NCT00785486|"~     This is an open label non-randomized single sequence, single group two way drug interaction~     study in healthy adult volunteers to determine the extent to which quinine, an inducer of~     cytochrome p450 CYP 3A4, affects the pharmacokinetics of midazolam, an accepted probe drug~     for CYP 3A4. The study will also determine the extent to which midazolam affects the~     pharmacokinetics of quinine.~   "
211997|NCT00785473|"~     Several studies have shown that bone mineral density (BMD) at the femoral neck decreases with~     increasing physical handicap (EDSS-score) in MS patients. Possible explanations are less~     weightbearing exercise or less UV-exposure resulting in reduced vitamin D generation in the~     skin. Prevention of osteoporosis is a high priority, because treatment of the established~     disease remains sub-optimal.~      We have designed a double-blind randomised controlled trial of two years' duration including~     90-100 persons with MS age 18-50 to assess whether supplementation with vitamin D, given as a~     weekly dose of 20,000 IU cholecalciferol, can prevent bone loss.~      The primary objective of this study is to determine changes in BMD over the 2 year study~     period comparing treatment and placebo groups.~      The most important secondary objective is to determine cytokine profiles in blood samples. We~     will also assess parameters related to vitamin D status and physical performance.~   "
211998|NCT00785460|"~     Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects~     smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation of the~     brachial artery.~   "
212032|NCT00785018|"~     Excessive inflammation is associated with tissue damage caused by over-activation of the~     innate immune system. This can range from mild disease to extreme conditions such as multiple~     organ failure (MOF). In marked contrast to adaptive immunity which is very sensitive to~     immune modulators such as steroids, the innate immune system cannot be sufficiently targeted~     by currently available anti-inflammatory drugs.~      We hypothesize that C1-esterase inhibitor can modulate the innate immune response.~      In this study, human endotoxemia will be used as a model for inflammation. Subjects will,~     additionally to endotoxin, receive C1 esterase inhibitor or placebo. Blood will be sampled to~     determine the levels of markers of the innate immune response.~   "
211999|NCT00785447|"~     The purpose of this study is to find out the best way of providing artificial breathing~     during cardiopulmonary resuscitation (CPR). Current standard CPR involves giving~     mouth-to-mouth breathing to people requiring CPR. The rescuer pinches the person's nostrils~     closed and breathes into the mouth of the unconscious person with his or her own mouth.~      Some CPR studies have shown that it might be easier and more effective to breathe air into a~     person's nose instead of the mouth. People receiving CPR often have blocked airways, so~     breathing into the mouth does not always work.~      We think mouth-to-nose breathing may be more efficient and easier to do. In this case, the~     rescuer closes the person's mouth by pushing the jaw up and holding it still. Then the~     rescuer breathes into the unconscious person's nose by covering the nose entirely with his or~     her mouth. We are doing this study to try to find out which way works better.~      We will perform both ways of breathing on people who are unconscious (asleep) before planned~     (non-emergency) surgery and compare their effectiveness.~   "
212000|NCT00785434|"~     This will be an open label study of escitalopram. Patients not responsive to citalopram will~     be switched directly to escitalopram.~      Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they~     either achieve remission (MADRS <9) or fail to tolerate the dose.~   "
212001|NCT00785421|"~     To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is~     powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the~     experimental arm.~      N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%~   "
212002|NCT00785408|"~     A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine~     the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or~     overweight subjects.~   "
212003|NCT00785395|"~     This study is designed to determine the minimum effective dose (ED90) of infusions of~     oxytocin for the prevention of uterine atony / postpartum hemorrhage and the need for~     additional uterotonics, in low risk parturients presenting for an elective CD.~      The primary outcome measure is the response of effective uterine contraction as either~     satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin~     infusion dose. Secondary outcomes will include need for additional uterotonics, calculated~     intra-operative blood loss and presence of oxytocin related adverse effects.~   "
212004|NCT00785382|"~     We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate~     markers postoperative pain rating scores and postoperative opioid consumption while improving~     the quality of recovery following breast cancer surgery compared to placebo. The primary~     outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR)~     in the first 24h postoperative period. Do women undergoing breast cancer surgery with general~     anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS~     and a greater QoR score in the first 24 hours after their surgery than those women who~     received placebo?~   "
212005|NCT00785369|"~     The purpose of this study is to image pigmented skin lesions suspicious for melanoma with an~     imaging technology called in vivo reflectance confocal microscopy. This technology uses low~     intensity laser to image below the surface of the skin. The confocal images of the suspicious~     skin lesion will be examined. The goal of this study is to compare the results of the~     confocal image examination to the pathologic diagnosis of the skin lesion.~      The technique being evaluated in this study uses reflectance confocal microscopy in vivo. The~     term in vivo means in/on a living subject. In this study you will be the living subject and~     the confocal microscope will be placed on your skin to look at your skin lesion. The confocal~     microscope uses a weak laser light and a sophisticated lens to image the individual cells~     that make up the skin. Your lesion will be photographed with high resolution photography.~   "
212006|NCT00785356|"~     Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg~     elemental iron) iron supplements twice daily.~   "
212007|NCT00785343|"~     The purpose of this study is to compare standard occupational therapy to a combination of~     conventional (standard) and robotic therapy. The Reo Go device will provide robotic therapy~     that gives therapists a tool that could make stroke treatment faster and better by helping~     patients practice more accurate arm movements with help from the device.~   "
212008|NCT00785330|"~     DSHNHL R3 is a randomized clinical phase II study. The main objective is to estimate the~     efficacy of rituximab as a prophylactic medication for prevention of~     graft-versus-host-disease after allogeneic peripheral stem cell transplantation in patients~     with a high risk relapse of aggressive B-cell Non-Hodgkin's lymphoma. The most important~     secondary objective is to estimate the efficacy of allogeneic stem cell transplantation in~     this clinical situation.~   "
212009|NCT00785317|"~     The purpose of this study is to evaluate the effects on breast in postmenopausal women~     randomized to either oestradiol in combination with DRSP or E2 in combination with NETA~     during six months.~   "
212010|NCT00785304|"~     Thousands of soldiers, marines, and other military personnel have had injuries to the brain~     due the wars in Iraq and Afghanistan. In addition, 1.5 million civilians per year in the~     United States have traumatic brain injuries caused by car accidents, falls, sports-related~     injuries or assaults. There are important advances in technology that we think will help us~     learn a lot more about these injuries. One such advance involves new types of MRI scans that~     we think will be able to show what has happened to the brain after trauma more clearly that~     regular scans can. These first new scan is called diffusion tensor imaging, which shows~     injury to the axons (the wiring of the brain). The second new scan is called resting-state~     functional MRI correlation analysis, which shows how well various parts of the brain are~     connected to each other. Importantly, the new types of scans can be done using regular~     scanners that we already have in every major hospital. The innovation is entirely in how the~     scanners are used and how the resulting pictures are analyzed on a computer after they have~     been taken.~      Our overall goal is to see whether these new MRI scans will be useful for people who have had~     traumatic brain injuries. We have already tested them on some civilian brain injury patients~     and found them to be very helpful. For this study, we will test them on military personnel~     who have had traumatic brain injuries caused by explosions. The specific goal will be to see~     if the amount of injury we see can be used to predict how well the patients will do overall~     over the next 6-12 months. We think with the new scans we will be able to predict overall~     outcomes better than with regular scans and other information. A related goal will be to see~     whether injuries to specific parts of the brain seen by these new scans can be used to~     predict whether patients will be likely to have specific problems like memory loss, attention~     deficit, depression, or post-traumatic stress disorder. A final goal will be to repeat the~     scans 6-12 months later to see whether the new MRI scans can show whether the injuries to the~     brain have healed, gotten worse, or stayed the same.~      If the study is successful, it will show that these new MRI techniques can to be used to make~     earlier and more accurate diagnoses of traumatic brain injury, predictions of the sorts of~     problems that are likely to occur after brain injury, and assessments of how severe the~     injuries are.~      This study will help traumatic brain injury patients. It will be most useful for military~     personnel who have had brain injuries due to explosions. It is highly likely that it will~     also be useful for younger adults who have had brain injuries due to other causes like car~     accidents, sports-related concussions, falls, or assaults. It is possible that but not known~     for sure whether it will help young children or older adults with traumatic brain injuries.~      These new scans could help with decisions about whether military personnel can return to~     duty, what sort of rehabilitation would benefit them most, and what family members should~     watch for and expect. This could become used in some hospitals within 2 years, and could~     become standard in every major hospital within 5 years.~      The new scans could also be helpful in developing new treatments. For example, if a new drug~     works by blocking injury to the axons, it would be a good idea to test on people who have~     injury to their axons. Right now we have no good way to tell who these people are, and so a~     new drug like this would get tested on lots of people who don't have injured axons, along~     with those who do. This would make it harder to tell if the new drug is working. With the new~     scans we should be able to tell who has injured axons, tell how severe the injury is, and~     figure out whom to test the drugs on. It will likely take 10 years or more to develop new~     drugs like this.~      Further in the future, the new scans could be used to help guide surgery to implant computer~     chips to help rewire the brain. We don't know how long this will take, but estimate 15-20~     years or more.~      Overall MRI scanning is very safe and has no known major risks. Because the scanner uses~     strong magnets, anyone with metal objects in their bodies can't be scanned, as this could be~     dangerous. We will make sure that no one with metal objects in their bodies is included in~     the study. There can be some psychological risks involved in taking tests and answering~     questions, but these are usually mild and can be managed. There is always a risk that~     important confidential information will be made public and that this could have consequences.~     We will do everything possible to maintain confidentiality. Nearly all of the information~     will only be identified using a code number and not by the name of the person, and all of it~     will be kept securely.~   "
212011|NCT00785291|"~     This randomized phase III trial studies the side effects and how well different chemotherapy~     regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV~     breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized~     nanoparticle formulation (nab-paclitaxel), and ixabepilone, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Bevacizumab may block tumor growth by targeting certain cells~     and slowing the growth of blood vessels to the tumor. It is not yet known which treatment~     regimen is more effective in treating patients with breast cancer.~   "
212033|NCT00785005|"~     Given that sedentary behavior is associated with T2DM, the purpose of this study is to~     evaluate whether subjects with T2DM have a significant disincentive to performing exercise~     (due to greater perceived effort) . This study will prospectively compare the perceived~     exercise effort between T2DM and non-diabetic women while adjusting for potential confounders~     including baseline physical activity. This study will also assess whether perception of~     effort is associated with physiologic parameters related to exercise effort. Finally, we have~     3 hypothesis-generating exploratory aims designed to screen for additional psychological and~     physiologic parameters that may increase perceived effort in those with T2DM.~      Hypothesis 1: At the same absolute workload (e.g., 30 watts) and the same relative workloads,~     it is a greater effort for women with T2DM to exercise than for non-diabetic women.~      Specific Aim 1: To determine differences in subjective perceived effort of bicycle exercise~     at low-to-moderate workloads in sedentary women with Type 2 Diabetes Mellitus (T2DM) vs.~     non-diabetic sedentary women.~      Hypothesis 2: There will be a significant association between RPE and the physiologic~     measures related to work intensity (e.g., relative work intensity and tau2).~      Specific Aim 2: In the same populations as SA1, to determine the strength of association~     during bicycle exercise between subjective perceived effort and physiologic measures related~     to work intensity.~      Exploratory Aims:~      Exploratory Aim 1: In the T2DM group described in SA1, to determine the strength of~     association during bicycle exercise between subjective effort and additional physiologic~     measures~      Exploratory Aim 2: In the T2DM group described in SA1, to determine the strength of~     association during bicycle exercise between subjective effort and psychologic measures~     related to perception of effort.~   "
212012|NCT00785278|"~     Individuals who use a manual wheelchair depend upon their upper limbs to provide a means of~     locomotion during completion of their activities of daily living. As a result of greater than~     normal usage of the upper limbs, shoulder pain and pathology is common among manual~     wheelchair users. Accordingly, proper wheelchair set-up may be paramount to preventing~     injuries and maintaining comfort during locomotion.~      The purpose of this research study is to create a subject-specific computer model of~     wheelchair propulsion to provide information on wheelchair set-up (in particular, axle~     placement). The primary objective of this study is to investigate the effect of wheelchair~     set-up on shoulder joint forces during wheelchair propulsion; the secondary objective is to~     develop a predictive model to identify differences in shoulder joint forces that result from~     altering the axle position and seating set-up in user's wheelchairs.~      The hypothesis of the study is that outputs from a patient-specific model will reveal that~     the current axle position for each subject results in peak shoulder joint forces that are~     greater than those predicted from an altered axle position (determined by the model). The~     overall goal is to then adjust each manual wheelchair user's axle placement to one that~     minimizes the magnitude of shoulder joint forces throughout propulsion. It is intended that~     in doing so, the repetitive strain injuries associated with manual wheelchair propulsion may~     be reduced, prolonging a pain-free way of life for this population.~   "
212013|NCT00785265|"~     The main purpose of this study is to learn which educational method is most helpful to~     patients and their family members when they consider whether to pursue live donor kidney~     transplantation.~      Patients who are eligible for a kidney transplant usually get information in the transplant~     clinic about two types of kidney transplants - one where the kidney comes from a dead donor~     and one where the kidney comes from a healthy living donor. Patients are given this~     information by a transplant nurse or doctor and then encouraged to discuss it with family~     members and friends.~      In this study, we are trying to see if changing how and where we give patients this~     information makes a difference in how patients and their family members think about live~     donor kidney transplantation. So, we are looking at whether getting the information in the~     transplant clinic - either alone or in a group - is the same or different than getting the~     same information in your home.~      The study is only recruiting African American patients. This is being done because African~     Americans have a higher likelihood of developing chronic kidney disease and needing a kidney~     transplant than patients of other races. However, they wait longer for a kidney transplant~     and die at a higher rate on the waiting list because they are less likely than other patients~     to receive a live donor kidney transplant. We want to see which educational approach works~     best with African American patients and their families.~   "
212014|NCT00785252|"~     Multicenter randomized study to compare powered intraosseous access to standard central line~     access for the administration of fluids and drugs for patients in the Emergency Dept.~   "
212015|NCT00785239|"~     The purpose of this study is to create a patient registry to collect and analyze information~     on subjects treated with the CryoSpray Ablation™ System post-510K approval.~   "
212016|NCT00785226|"~     Phase 1/2 dose escalation study to investigate the combination of RDEA119 and sorafenib in~     advanced cancer patients.~   "
212017|NCT00785213|"~     Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is~     an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine~     sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy adult~     subjects.~   "
212018|NCT00785200|"~     The goal of this 3-year project is to control the spread of community-associated~     methicillin-resistant Staphylococcus aureus (CA-MRSA) in the Dallas County Jail. CA-MRSA is a~     bacterium spreading rapidly through healthy populations and becoming an epidemic in many~     regions of the U.S. Many people in the community are asymptomatically colonized by MRSA.~     There have been outbreaks of MRSA infections at prisons and jails. We will study the spread~     of MRSA in the jail to better understand how the bacteria are transmitted from person to~     person there and how we can prevent their transmission. All detainees asked to participate~     must give informed consent to do so; their privacy will be carefully protected. Detainees~     with a history of allergy to CHG will be excluded. Seventeen objects in the jail will be~     sampled for contamination with MRSA. Bacteria will be collected from all cultures obtained~     from patients with bacterial skin infections for 18 months in a part of the jail in order to~     determine how frequently these infections are caused by MRSA relative to other bacteria. A~     group of about 1500 adult detainees will be tested for colonization with MRSA in order to~     determine how commonly detainees carry the bacterium. A cluster-randomized 6-month study will~     be undertaken among these detainees and those who take their places when they leave the jail~     to determine if chlorhexidine (CHG)-containing disposable wash cloths for skin cleaning can~     decrease the prevalence of MRSA skin or nose colonization. Detainees receiving CHG cloths~     (about 500 detainees) will be compared to detainees receiving water-soaked cloths for skin~     cleaning (about 500 detainees) or no intervention (about 500 detainees). The primary outcome~     will be a difference in average colonization prevalence in detention tanks, which are~     discrete detention units housing detainees, comparing the usual care to the CHG-exposed tanks~     after 6 months of CHG cloth use. A secondary outcome will be a decrease in skin infections~     from any cause in the tanks receiving CHG compared with usual care. All of the MRSA isolates~     and a sample of the S. aureus isolates susceptible to methicillin from specimens colonizing~     or infecting detainees, as well as those contaminating surfaces and objects in the jail will~     be tested genetically in order to determine which strains of MRSA are present in the jail.~     This study may identify ways to stop the spread of MRSA among people in jails and prisons, as~     well as other places.~   "
212019|NCT00785187|"~     Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema.~      Study design: A single-center, prospective, randomized, crossover, open study.~      Number of patients: 20-40~      Patient population: Healthy volunteers~      Control: Different sites on patients body~      Procedure duration: Total 3-5 hours (4 visits)~      Duration of follow up: 4 days~      Duration of study: Up to 6 months~      Primary objectives: To examine the difference in erythemal response as a function of dose~     rate, and to assess the total amount of energy that is theoretically transmitted through a~     sunscreen within the range of SPF 2-10.~   "
212034|NCT00784992|"~     Aim of study is to investigate whether the use of silicone tubes in endonasal DCR surgery~     increases the success rate and / or complication rate compared to surgery without tubes.~   "
212035|NCT00784979|"~     The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to~     high responder renal transplant patients who otherwise may never be compatible with a~     potential organ donor. PRA reduction is offered in the following phases:~        1. Immunological Testing~        2. Transplant Nephrectomy~        3. Pharmacologic Therapy~        4. Plasmapheresis~        5. Transplant~   "
212036|NCT00784966|"~     The purpose of this study is to determine if prolonged administration of the anti TNF (tumor~     necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in~     patients undergoing islet after kidney transplantation.~   "
212393|NCT00780169|"~     The purpose of this study is to assess the safety, the maximum tolerated dose and the~     recommended dose for phase II studies of a chemotherapy-combination of sorafenib, irinotecan,~     and 5-fluorouracil (5-FU)/folinic acid (FA) (FOLFIRI) as first-line treatment for metastatic~     colorectal cancer.~   "
212020|NCT00785174|"~     Non-invasive ventilation (NIV) has become now a widely used treatment modality in ICU and~     emergency services to deal with respiratory failure.1 NIV has the potential to improve~     ventilatory assistance while avoiding endotracheal intubation and its complications.~      Since the first publications of Meduri2 and Brochard3 the number of studies on the NIV has~     been growing and developing and this technique becomes one of the major progress in the field~     of respiratory assistance. Decompensation of chronic obstructive pulmonary disease (COPD) is~     certainly the least questionable indication of the NIV. However, indication of the NIV is~     inexorably spreading to other types of acute respiratory insufficiency, including acute~     cardiogenic pulmonary edema (CPE).4 Continuous positive airway pressure (CPAP) is the most~     currently used non-invasive ventilation usually performed without the use of a ventilator.~     NIV using pressure support (NIPSV) combined pressure support (inspiratory aid) and positive~     expiratory pressure as in CPAP. Based on physiological ground, NIPSV would be more performant~     than CPAP to improve ventilatory parameters and reduce the work breathing in APE. However,~     this issue is not settled yet. Number of meta-analysis over the last 2 years were devoted to~     the comparison of CPAP and NISPV,5 so that the scientific evidence is still far from~     established. In addition, it is not sur that patients enrolled in these studies are~     representative of all patients with APE. The fact that they were included solely on the basis~     of clinical criteria, the risk of overlap with other diagnoses is not negligible. Thus the~     use of markers of heart failure as the BNP (brain natriuretic peptide) would be very useful.~     On the other hand, the possible deleterious effect of NIPSV on myocardial perfusion is a~     problem that has not been definitively resolved.~      Objectives of the study:~        1. Compare the efficacy and safety of the NIPSV with those of CPAP in patients presenting~          to the emergency department with CPE.~        2. Compare the two procedures in subgroups of patients with hypercapnia and high BNP~          concentration.~   "
212021|NCT00785161|"~     The primary aim of this study are to gather data on the real world experience of the~     Penumbra System and to determine if there is a correlate between the imaging-defined size of~     the ischemic penumbra at admission and patient outcome in patients already treated by the~     System. This will be accomplished by the collection of all available admission imaging data~     along with patient clinical and functional outcome results at 90-day follow-up to determine~     if a positive association exists between these variables. A secondary aim is to collect and~     summarize the 90-day functional outcome data for the purpose of sample size estimation for a~     potential randomized concurrent controlled trial. This will be accomplished by collecting the~     data on 90-day modified Rankin Scores (mRS) and all cause mortality.~   "
212022|NCT00785148|"~     To prove the safety of the gynaecological formulation in normal conditions of use.~   "
212023|NCT00785135|"~     The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical~     Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated~     when a kind of correction called vertical prism is added to the patient's normal eye glass~     prescription.~      The experiment will involve giving the patient two pairs of glasses (one pair containing the~     baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair~     containing the baseline prescription but without vertical prism (Placebo Glasses)) to~     demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness,~     headache and / or anxiety in these patients.~   "
212024|NCT00785122|"~     This study is being conducted in order determine whether IMA910 as single agent with GM-CSF~     as adjuvant following pre-treatment with low-dose cyclophosphamide is safe and shows~     sufficient anti-tumour effectiveness in patients with advanced CRC to warrant further~     development. Secondary objectives of this study are investigation of immunological parameters~     and additional effectiveness endpoints. Furthermore, safety, immunological parameters and~     effectiveness of IMA910 as single agent with GM-CSF in combination with imiquimod following~     pre-treatment with low-dose cyclophosphamide will be investigated in a 2nd cohort of~     patients.~      The regular study duration for individual patients in the 1st and 2nd cohort comprises~     regularly 18-42 days of screening (excluding HLA-typing), 33 weeks of treatment (16~     vaccinations) and 4 weeks follow-up. Thus, the period between start of screening and end of~     trial is about 10 months per patient. Patients will be followed for response to subsequent~     treatments (chemotherapies with or without targeted agents) and survival every 2 months after~     EOS visit until death.~      Patients in the 1st and 2nd cohort will be withdrawn from study treatment once a progress~     according to RECIST is noted. An enrolment plan for the first 6 patients included into the~     1st cohort will be part of this study to ensure maximum safety of the study participants. The~     enrollment of the first 6 patients into the 2nd cohort will also follow an enrolment plan to~     ensure maximum safety.~   "
212025|NCT00785109|"~     In this mono-center,open,three-armes, controlled, randomized phase I study the progress of~     aortic valve calcification with and without vitamin K supplementation will be investgated.~     This will be done by means of measurements of concentrations from osteocalcine and MPG in~     blood serum, echocardiography, cardiac computed tomography and cardiac MRI~   "
212026|NCT00785096|"~     The purpose of this study is to assess how patients, nurses and physicians perceive negative~     events following surgical procedures.~   "
212027|NCT00785083|"~     This study will evaluate the effect of FTY720 on the lung function of patients with moderate~     asthma~   "
212028|NCT00785070|"~     -  Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA~          cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System)~        -  Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep~          study device results.~        -  Evaluate effectiveness of the home sleep study testing in the orthopedic presurgical~          population.~   "
212029|NCT00785057|"~     This study will compare hypertension treatment pattern of stroke patients with non-stroke~     patients receiving medical care from outpatient clinics at neurology specialty centers in~     Korea. It will evaluate target BP achievement rate in patients with stroke compared to~     patients without stroke and investigate factors affecting BP target goal efficacy in these~     patients.~   "
212030|NCT00785044|"~     The study was designed to study the utility of meta-iodobenzylguanidine (123I-mIBG) imaging~     to identify those participants with heart failure who would experience an adverse cardiac~     event during 24 months of follow-up from the administration date of 123I-mIBG in previous~     studies MBG311 or MBG312.~   "
212031|NCT00785031|"~     The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet~     based vascular risk factor program on top of usual care compared to usual care alone for~     treatment of vascular risk factors in patients at high risk for new vascular events.~   "
212037|NCT00784953|"~     A non-interventional study to explore actual asthma control status in real-life environment~     and to observe the efficacy after stepped-up to Symbicort SMART or various identical~     regimens.~      The study will be implemented by screening asthmatic patients from respiratory clinics to~     identify those not optimally controlled and required stepping up the controllers to initiate,~     or to titrate dose of, ICS/LABA including Symbicort.~   "
212039|NCT00784927|"~     RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the~     cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help~     kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as~     cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide~     together with rituximab, cyclophosphamide, and dexamethasone may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving lenalidomide together with~     rituximab, cyclophosphamide, and dexamethasone works in treating patients with previously~     untreated low-grade non-Hodgkin lymphoma.~   "
212040|NCT00784914|"~     RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Studying samples of blood and tumor tissue from patients with cancer~     in the laboratory may help doctors learn more about how this treatment is used by the body.~      PURPOSE: The purpose of this study is to evaluate the feasibility of using a microdialysis~     catheter to see what effect temsirolimus has on various biological substances associated with~     brain tumors over time.~   "
212041|NCT00784901|"~     Purpose: To study the associations between visual functions and the retinal tomography~     detected by optical coherence tomography (OCT) in patients with retinitis pigmentosa (RP).~      Study design: retrospective, non-randomized and non-comparable study Material: Medical~     recordings of the RP patients who visited the Out-Patient Department of Ophthalmology in NTUH~     during June, 2003 to June, 2008.~      Methods: By reviewing charts of the RP patients, the investigators will categorize RP~     patients into different types according to the loci of the pathological change in their~     retina evaluated by opththaomoscopy. And the investigators will collect the data of their~     visual functions including visual acuity, visual field, Arden ratio of electrooculography,~     and color sense discrimination. Then, according to the OCT map, the investigators will~     analyze the retinal thickness by dividing the macular area into foveal area, inner ring and~     outer ring. Finally, the investigators will analyze the relationships between visual~     functions and retinal thickness in different macular areas in different types of RP patients.~      Anticipated results: The investigators expect that retinal tomographies may different among~     different types of RP. And the retinal tomographic change may correspond to the change of a~     certain kind of visual function. Hence, according to the thickness of a specific area in~     macula, the investigators may anticipate that some visual dysfunction may exist.~   "
212042|NCT00784888|"~     The purpose of this study is to follow safety and quality of life outcomes on patients~     switching from tamoxifen therapy to aromatase inhibitor therapy.~   "
212043|NCT00784875|"~     The purpose of this study is to compare an investigational drug (LY2624803) with placebo and~     with zolpidem in the treatment of outpatients with chronic insomnia.~   "
212044|NCT00784862|"~     To assess the effect of ARIMIDEX on the pharmacokinetics of tamoxifen and the effects of~     tamoxifen on the pharmacokinetics of ARIMIDEX..~   "
212045|NCT00784849|"~     The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary~     lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.~   "
212046|NCT00784836|"~     The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon~     beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with~     relapsing multiple sclerosis. The secondary objective of this study was to evaluate the~     safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects~     with relapsing MS.~   "
212047|NCT00784823|"~     The purpose of this study is to determine the tolerance and potential efficacy of combining~     dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma~     undergoing autologous stem cell transplantation.~   "
212048|NCT00784810|"~     The purpose of this study is to compare oxycodone/naloxone combination tablet and~     codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or~     pain due to osteoarthritis.~   "
212049|NCT00784797|"~     Second trimester abortion can be done surgically or medically. Medical abortion with~     mifepristone and misopristol is one of the common protocol, but misopristol have high rate~     side effect. The investigators recent study proved the efficacy of pitocin after mifepristone~     in second trimester abortion with minimal side effects.~      Working hypothesis and aims: To compare misopristol and pitocin after mifepristone~     preparation in second trimester in seccess rate, interval to abortion, side effects and~     patient satisfaction.~   "
212050|NCT00784784|"~     This unblinded pilot study is intended to assess the feasibility of a larger double-blind,~     randomized control trial. For the larger trial the investigators are interested in~     understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors~     for influenza infection in healthy adults, and in assessing the safety and tolerability of~     seasonal antiviral prophylaxis in healthcare workers.~      The pilot study will be assessing the rate of infection with influenza and the rate of~     adherence to long-term zanamivir in 60 healthy volunteers.~   "
212051|NCT00784771|"~     Chronic combat-related posttraumatic stress disorder can be difficult to treat. The~     investigators believe that hypnosis, with a stress on the sensation of scent which often~     plays a role in the traumatic memories, can offer help for victims of this disorder who~     continue to suffer after receiving other treatments.~   "
212052|NCT00784758|"~     The purpose of this study is to investigate the effects of Fenzian™ treatment on symptoms~     (such as shortness of breath), lung function (how well the lungs work), and~     albuterol/salbutamol (rescue medication) use in people with asthma. This will be done by~     comparing the effects of Fenzian™ treatment to the effects of a sham treatment, which looks~     the same as the Fenzian™ device but doesn't do anything.~      The Fenzian™ device is an electrical instrument that the investigators hope will help reduce~     airway inflammation associated with asthma symptoms by stimulating the nerves with very low~     electrical currents. The study device will be applied directly to the skin on the back,~     working along the ribs toward the spine, alternating between left and right sides, and on~     your face.~   "
212053|NCT00784745|"~     The purpose of this study is to examine whether there is a causal relationship between~     insulin resistance and/or glucose intolerance in the development of a defect incretin effect.~   "
212058|NCT00784680|"~     To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX~     plus NOLVADEX combination group during the first two years of treatment. (a) To compare the~     difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To~     compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX~     group for non-inferiority; if non inferiority is concluded, the difference in QOL between~     these two groups will be assessed.~   "
212059|NCT00784667|"~     This is a clinical trial investigating the effectiveness and safety of the combination of the~     study drugs cetuximab and erlotinib in patients with advanced (metastatic) refractory~     colorectal (bowel) cancer. If bowel cancer has spread to other organs (metastatic colorectal~     cancer), it is usually incurable and life-expectancy without treatment is less then 6 months~     on average. Currently, chemotherapy has been shown to have a significant impact in advanced~     colorectal cancer in terms of maintenance of quality of life and extension of survival.~     However, ultimately tumours will develop resistance to chemotherapy. Treatment options and~     subsequent survival at that stage are very limited. Therefore, new therapeutic approaches are~     urgently needed.~      It is common for colorectal cancer cells to contain growth receptors, like antennae, on their~     surface which regulate their growth. The drugs used in this trial have been shown to be~     effective in targeting one of these growth receptors; the epidermal growth factor receptor~     (EGFR). Cetuximab is an antibody (protein produced by the immune system involved in the~     defense of the body against infections) against EGFR. Cetuximab has been shown to improve the~     survival of patients with chemotherapy refractory advanced colorectal cancer. Erlotinib is a~     protein that prevents activation and hence signaling by EGFR. Erlotinib improves survival in~     patients with advanced lung cancer. Although, each of these drugs are known to be effective~     at inhibiting EGFR when they are given alone, at least in some cases, it is hoped that using~     two drugs that target the same receptor pathway in different ways will provide a more~     effective treatment.~      50 patients from four hospitals in Australia will participate in this trial, with~     approximately 25 patients being enrolled at Austin Health. All participants will receive the~     same treatment.~      Neither of the study drugs are chemotherapy, and hence it is expected that the treatment~     would be well tolerated. The most frequent side effect associated with EGFR inhibitors is~     skin rash. Other possible side effects are diarrhea and low magnesium levels.~   "
212060|NCT00784654|"~     The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after~     administered to children and adolescents aged 6-17 with ADHD for at least 6 months~   "
212061|NCT00784615|"~     Polycystic ovary syndrome (PCOS) is a very frequent endocrine disease of women in~     reproductive age, with an estimated prevalence of 5 to 10 % according to the studied~     population. In 2003 a committee of experts joined in Rotterdam under the auspice of the~     American Society for Reproductive Medicine and the European Society for Human Reproduction~     and Embryology, defined diagnostic criteria. It should include unless two of the following:~     menstrual irregularities; excess of male hormones (clinic or biochemical) and polycystic~     ovaries under ultrasound examination; giving rise to four subgroups or phenotypes:~      1- Women with polycystic ovaries, hyperandrogenism and oligoamenorrhea . 2. Women with normal~     ovaries, hyperandrogenism and oligoamenorrhea. 3- Women with polycystic ovaries,~     oligoamenorrhea without hyperandrogenism. 4- Women with polycystic ovaries, hyperandrogenism~     with normal menses. PCOS shares components of Metabolic Syndrome for the high prevalence of~     insulin resistance (abdominal obesity, impaired glucose tolerance, type 2 diabetes,~     hypertension, endothelial dysfunction, impaired lipid profile and probably cardiovascular~     disease). All these findings lead us to assume that women with PCOS could have an increased~     risk of developing cardiovascular disease. Nevertheless it is premature to assume that every~     PCOS phenotype has the same cardiac and metabolic risk factors. So, it is important to~     evaluate the endocrine and metabolic characteristic in different phenotypes of PCOS to~     prevent the co morbidities that predispose to cardiovascular disease. And of course to avoid~     unnecessary measures in groups that could not show increased risk.~   "
212062|NCT00784602|"~     To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary,~     bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving~     patient determined treatment goals.~   "
212063|NCT00784589|"~     Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5~     and 10 percent depending on the severity of disease and age of patients.~      The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5.~     mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine,~     mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has~     demonstrated the superiority of the combination of corticosteroids and immunosuppressive~     drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease,~     control trials are difficult to conduct. Evaluation of the different treatment regimens~     proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or~     new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against~     B- lymphocytes) or immunoadsorbtion.~   "
212064|NCT00784576|"~     The objective of the present research is to evaluate the incidence and independent predictors~     of delirium observed among patients after cardiac surgery. Moreover, to asses the sensitivity~     and specificity of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition~     criteria (DSM-IV) and International Statistical Classification of Diseases and Health Related~     Problems - Tenth Revision criteria (ICD-10), and the cut-off values of the Memorial Delirium~     Assessment Scale (MDAS) and Delirium Index (DI) in diagnosing postoperative delirium.~   "
212065|NCT00784563|"~     Motivated by reported improvements in aerobic fitness and executive functions after a 6-month~     aerobic walking intervention in normal sedentary elderly, we conducted a Phase I/II study to~     investigate effects of aerobic exercise on motor function, cognition, and quality of life in~     mild-moderate patients with Parkinson's disease (PD). To identify the best method to deliver~     fitness training, we also aimed to compare safety, tolerability, and fitness benefits between~     different training methods (continuous/moderate intensity vs. interval/alternating between~     low and vigorous intensity) and exercise settings (individual vs. group). Interval training~     reportedly facilitates higher fitness gains than continuous training. Group training may~     promote success through social interaction, whereas individual training offers greater~     flexibility.~      Details of the study can be found in the publication below:~      Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting.~      Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta~     S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG.~      Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2.~      PMID: 24991037~   "
212066|NCT00784550|"~     The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR~     DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA®~     HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg~     (TIOTROPIUM) in patients with COPD.~      SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH & Co. KG.~      ADVAIR DISKUS® are registered trademarks of the GSK group of companies.~   "
212067|NCT00784537|"~     The purpose of this study is to define an improvement in patients:~        -  To evaluate if patients resistant to the initial treatment for residual PET-positive~          masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early~          shift to high-dose chemotherapy supported by stem cell rescue~        -  To analyse if patients achieving early complete response (PET-2 negative), can be spared~          the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned~          six courses of ABVD. To answer this question, PET-2 negative patients will be randomized~          between radiotherapy versus no radiotherapy at the end of ABVD therapy.~   "
212068|NCT00784524|"~     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.~     Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving vaccine~     therapy together with aldesleukin may be a more effective treatment for metastatic breast~     cancer.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with~     aldesleukin works in treating women with metastatic breast cancer.~   "
212069|NCT00784511|"~     North American blacks tend to have low blood levels of vitamin D because pigmentation blocks~     vitamin D production in the skin. They also have higher rates of developing type 2 diabetes~     and higher rates of complications from the disease compared with whites. Although there is~     compelling evidence that adequate vitamin D may reduce the risk for type 2 diabetes in~     whites, recent evidence from a national survey demonstrated an association of vitamin D with~     diabetes in whites but not in blacks. However, the central hypothesis of this study is that~     providing enough supplemental vitamin D to blacks (raising their blood levels higher than~     that of most participants in the survey) will improve blood measures related to diabetes~     risk. The proposed study is a 12-week randomized, double-blind, placebo-controlled experiment~     designed to examine the effect of vitamin D supplementation (100 μg/d ) on insulin secretion,~     insulin sensitivity and glucose control in pre-diabetic black men and women aged 40 and~     older.~   "
212070|NCT00784498|"~     The use of procedural sedation and analgesia (PSA) to accomplish painful procedures in the~     emergency department (ED) has become a standard of practice over the last decade. Substantial~     variance exists regarding usage of medication for PSA, and many anesthetic agents have been~     proposed for this use.~      To our knowledge no head to head study compared the clinical effectiveness, safety profile~     and amnestic properties of midazolam/ketamine vs. propofol regimens for PSA in the adult ED~     setting.~      This prospective randomized trail can will help to evaluate the effectiveness and safety~     profile of Midazolam/katamine regimen for ED PSA in adults and will contribute to the~     discussion regarding propofol roll in the ED.~   "
212071|NCT00784485|"~     The purpose of this study is to look at the effectiveness of Xolair® (omalizumab) in people~     with asthma taking Advair Diskus®. The study will look at the effects of Xolair® on lung~     function using high resolution computed tomography (HRCT) scans after asthma symptoms are~     induced with a special substance called methacholine. This study is only taking place at~     UCLA, where about 13 subjects will be enrolled. Participation requires 10-14 visits over~     about 26 weeks.~      Subjects will receive an albuterol inhaler to use as needed for immediate relief of symptoms~     and fluticasone 250 mcg/salmeterol 50 mcg or fluticasone 500 mcg/salmeterol 50 mcg (Advair~     Diskus® 250/50 or 500/50) to be taken twice daily. At certain visits, they will be given~     Xolair® injections followed by various assessments, including CT scans and lung function~     tests.~   "
212072|NCT00784472|"~     The purpose of this study is to investigate the effect of oxynorm versus morphine after~     operation for kidney stone (PCNL). In addition the relationship between pain symptoms and~     referred sensory and trophic changes will be examined in the patients before and after the~     operation.Finally a blood sample is analysed to investigate pharmaca-genetics.~   "
212073|NCT00784459|"~     This study is designed to determine if treatment with abatacept is effective in decreasing~     allergic airway inflammation in mild, atopic asthmatics. Subjects will be recruited from the~     greater St Louis Metropolitan area. Eligible individuals will undergo a titrated skin prick~     test. Following baseline evaluation, fiberoptic bronchoscopy with segmental allergen~     challenge (SAC) will be performed. The subjects will be randomized to either placebo or~     abatacept. After 12 weeks of study drug, the subjects will undergo repeat SAC. The primary~     endpoint will be to determine if treatment with abatacept results in a 50% or greater~     decrease in the percentage of eosinophils recovered in the bronchoalveolar lavage (BAL) fluid~     following SAC as compared to placebo control. Secondary endpoints include measures of airway~     obstruction and hyperreactivity, airway inflammation and symptoms as well as determination of~     the safety of abatacept administration in this subject population.~   "
212074|NCT00784446|"~     Assessment of safety and toxicity, definition of the dose limiting toxicity (DLT) of the~     combination therapy consisting of Capecitabine, Oxaliplatin, Bevacizumab and Imatinib.~   "
212075|NCT00784433|"~     Moderate alcohol may be beneficial for diabetics~   "
212076|NCT00784420|"~     The purpose of this study is to estimate the effect of steady state raltegravir on the steady~     state pharmacokinetics of UK-453,061 and steady state UK-453,061 on the steady state~     pharmacokinetics of raltegravir.~   "
212077|NCT00784407|"~     The objective of this study is to compare the results of total thyroidectomy using the new~     harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device~     (HARMONIC ACE).~   "
212078|NCT00784394|"~     This phase I clinical trial studies the side effects and best dose of diindolylmethane in~     preventing cancer in healthy volunteers. Diindolylmethane is formed in the stomachs of people~     who eat a chemical that is normally found in vegetables, including cabbage, broccoli,~     Brussels sprouts, cauliflower, and watercress. Diindolylmethane may prevent the development~     of cancer.~   "
212079|NCT00784381|"~     To evaluate the quality of orders for target drugs in old patients with impaired renal~     function, hospitalized or living in long stay units, and to improve these practices by means~     of a counselling system coupled to a computer prescribing system~   "
212080|NCT00784368|"~     The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the~     body, distributed within the body, and how it is removed from the body over time) of~     itraconazole (ITCZ) oral solution in participants with Systemic Fungal Infection (SFI) and~     those with febrile (with fever) neutropenia (FN, decrease in white blood cells) suspected of~     fungal infection.~   "
233634|NCT00497952|"~     The goal of this research study is to establish chimerism in hopes to halt disease~     progression in patients with Multiple Sclerosis.~   "
212081|NCT00784355|"~     The causes of acute pancreatitis in Finland are alcohol overuse (60%), cholecystolithiasis~     (20%) and idiopathic (i.e. etiology unknown)(20%). Acute pancreatitis may recur in over half~     of cases and may be fatal in severe cases in 30%. Majority of idiopathic pancreatitis are~     caused by microlithiasis in gall bladder. The purpose of this randomized study is to prevent~     recurrence of idiopathic pancreatitis by performing laparoscopic cholecystectomy compared to~     non-operative group in 2 years follow-up of patients.~   "
212082|NCT00784342|"~     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap~     initiative to develop a computerized system measuring patient-reported outcomes in~     respondents with a wide range of chronic diseases and demographic characteristics. In the~     first four years of its existence, the PROMIS network developed item banks for measuring~     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical~     function, and social functioning. During the item banking process, the PROMIS network~     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses~     to refine the meaning, clarity, and literacy demands of all items. The item banks were~     administered to over 20,000 respondents and calibrated using models based on item response~     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were~     developed and implemented. The network has designed a series of studies using clinical~     populations to evaluate the item attributes, examine their utility as CATs, and validate the~     item banks. More information on the PROMIS network can be found at www.nihpromis.org.~   "
212083|NCT00784329|"~     To evaluate the potential of a new imaging device, termed Optical Frequency Domain Imaging~     (OFDI), in the early diagnosing of pulmonary malignancies in the central airways.~   "
212084|NCT00784316|"~     The aim of the study is to test the efficiency of intravenous administration of metoprolol~     versus intravenous administration of amiodarone in the prevention of atrial fibrillation~     after cardiac surgery.~   "
212085|NCT00784303|"~     The purpose of this study is to determine the safety and efficacy of oral E7080 in medullary~     and iodine-131 refractory, unresectable differentiated thyroid cancers.~   "
212086|NCT00784290|"~     The purpose of this study is to evaluate the safety and efficacy of Orantinib, an oral~     tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived~     growth factor receptor, and fibroblast growth factor receptor, in patients with advanced~     hepatocellular carcinoma (HCC).~   "
212087|NCT00784277|"~     The purpose of this study is to compare bowel function/constipation that occurs during~     tapentadol treatment with that occuring during oxycodone treatment, as measured by the~     frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel~     movements will be determined from a Bowel Function Patient Diary completed by the enrolled~     sujbects.~   "
212088|NCT00784264|"~     This is an observational study to measure the thickness of artery walls in the neck (intima~     media thickness IMT) by ultrasound examination in middle-aged subjects with central obesity.~     The purpose of this study is to obtain local data how common asymptomatic atherosclerosis is,~     and to investigate the association between Cardiovascular Disease risk factors and intima~     media thickness (IMT) in the Hong Kong population. Results from this study may enhance the~     public awareness of asymptomatic atherosclerosis and understand its role in the development~     of Cardiovascular Disease in Hong Kong.~   "
212089|NCT00784251|"~     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap~     initiative to develop a computerized system measuring patient-reported outcomes in~     respondents with a wide range of chronic diseases and demographic characteristics. In the~     first four years of its existence, the PROMIS network developed item banks for measuring~     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical~     function, and social functioning. During the item banking process, the PROMIS network~     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses~     to refine the meaning, clarity, and literacy demands of all items. The item banks were~     administered to over 20,000 respondents and calibrated using models based on item response~     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were~     developed and implemented. The network has designed a series of studies using clinical~     populations to evaluate the item attributes, examine their utility as CATs, and validate the~     item banks. More information on the PROMIS network can be found at www.nihpromis.org.~   "
212090|NCT00784238|"~     The purpose of this study is to evaluate improvement and efficacy of paliperidone~     extended-release for subjective well-being and drug attitudes of participants, when switching~     from oral antipsychotics in participants with schizophrenia (psychiatric disorder with~     symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self).~   "
212091|NCT00784225|"~     RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent~     cataracts or age-related macular degeneration in men receiving these drugs as part of a~     clinical trial for the prevention of prostate cancer.~      PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work~     in preventing cataract and age-related macular degeneration in men enrolled on SELECT~     (SWOG-S0000).~   "
212092|NCT00784212|"~     This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing~     lights of patients with photosensitive epilepsy, using EEG as a readout.~   "
212093|NCT00784199|"~     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap~     initiative to develop a computerized system measuring patient-reported outcomes in~     respondents with a wide range of chronic diseases and demographic characteristics. In the~     first four years of its existence, the PROMIS network developed item banks for measuring~     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical~     function, and social functioning. During the item banking process, the PROMIS network~     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses~     to refine the meaning, clarity, and literacy demands of all items. The item banks were~     administered to over 20,000 respondents and calibrated using models based on item response~     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were~     developed and implemented. The network has designed a series of studies using clinical~     populations to evaluate the item attributes, examine their utility as CATs, and validate the~     item banks. More information on the PROMIS network can be found at www.nihpromis.org.~   "
212094|NCT00784186|"~     The primary goal of this study is to determine the clinical advantage of pre-treatment with~     mifepristone in second trimester misoprostol induction abortion. This will be a randomized~     controlled double-blinded trial of 260 women comparing misoprostol alone to mifepristone plus~     misoprostol for second trimester (14-21 weeks' LMP) medical abortion.~   "
212095|NCT00784173|"~     Middle and inner ear malformations on two boys with velocardiofacial syndrome are~     discussed.Special attention should be given to the presence of hearing loss due to middle and~     inner ear malformations, in addition to frequent conductive hearing loss regarding mastoid~     and middle ear inflammatory processes.~   "
212096|NCT00784160|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the~     product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).~   "
212097|NCT00784147|"~     The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered~     via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to~     study drug, all patients will receive an optimized background regimen (OBR), which is a~     standard-of-care regimen selected by the investigator prior to randomization that is~     comprised of 2-4 antiretroviral agents. These agents must have been approved by the local~     regulatory agency or be available through expanded-access programs for treatment of human~     immunodeficiency virus (HIV).~   "
212098|NCT00784134|"~     The overall objective of this Phase III clinical trial is to obtain information from a~     population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of~     current clinical practice and national demographics of ICH regarding the benefit (or lack~     thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS).~     This application requests funding for five years to initiate a Phase III randomized clinical~     trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The~     investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue~     plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+~     placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH)~     and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd~     or 4th ventricles by intraventricular blood clot).~   "
212099|NCT00784121|"~     To demonstrate the absence of irritation potential (primary dermic irritability and cumulated~     dermic irritability) and allergy (sensibilization) of the product Dermacyd Breeze (Lactic~     Acid) Pocket BR.~   "
212100|NCT00784108|"~     The purpose of this study is to evaluate native tissue optical properties and photosensitizer~     optical properties in vivo with a novel, non-contact optical imaging device call Modulated~     Imaging to help optimize the laser exposure in future photodynamic treatment for patients~     with skin cancer.~      Photodynamic therapy involves the administration of a tumor-localizing photosensitizing agent~     that, when illuminated with the proper wavelength of light, can result in photochemical~     processes that cause irreversible damage to tumor tissues. Photodynamic therapy is~     non-invasive and has been shown to be effective in the treatment of skin cancer while~     producing excellent aesthetic appearance and psychological well-being in patients that~     normally would require invasive excisions.~   "
212101|NCT00784095|"~     The purpose of this study is to determine whether discussions of life story, forgiveness, and~     future goals improve quality of life for patients with serious illness.~   "
212102|NCT00784082|"~     In sickle cell disease (SCD), polymerisation of haemoglobin S and the resulting shape change~     of the red blood cells (RBC) lead to vascular occlusion and severe painful crises. Permanent~     inflammatory state and abnormal RBC adhesion to the endothelium trigger these phenomenon.~     Hydroxyurea (HU) is the only drug that has been shown to reduce clinical severity of SCD, and~     this was initially attributed to the stimulation of foetal haemoglobin (HbF). However, the~     clinical response does not correlate consistently with the degree and time of HbF increment,~     suggesting that HU clinical benefits may involve other mechanisms such as the induction of~     natural anti-inflammatory response via the hypothalami-pituitary-adrenal axis.~   "
212103|NCT00784069|"~     To demonstrate the absence of photoirritation and photosensitization potential of the product~     Dermacyd Breeze (Lactic Acid) Pocket BR.~   "
212104|NCT00784056|"~     The purpose of this study is to demonstrate the absence of photoirritation and~     photosensitization potential of the product Dermacyd PHDETINLYN Tangerine Mix (Lactic Acid).~   "
212105|NCT00784043|"~     The purpose of this study is to evaluate and document longitudinal efficacy in young children~     implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant~     systems.~   "
212106|NCT00784030|"~     Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and~     leads to kidney failure in half of all affected. Currently, no treatments exist for PKD.~     PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs~     called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue,~     leading to kidney failure. Based on evidence from basic science research it is believed that~     drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at~     changes in urine composition with high water intake in PKD-affected persons compared to~     healthy individuals.~   "
212107|NCT00784017|"~     This multicentric phase III study is designed to assess the efficacy and safety of~     recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of~     children with de novo ALL~   "
212108|NCT00784004|"~     Our aim in this study is to investigate the efficiency of the breathing with different~     breathing patterns. Ten volunteers and twenty patients having respiratory problems will be~     coached on their breathing through specific masks which will provide four different breathing~     patterns. These patterns will be 1) Breathing in through the nose only and out through the~     mouth only 2) Breathing in through the mouth only and out through the nose only 3) Breathing~     in and out through the nose only 4) Breathing in and out through the mouth only The data~     obtained from volunteers and patients will be compared within and between the groups.~   "
212130|NCT00783705|"~     This randomized phase II trial is studying inositol to see how well it works compared with a~     placebo in preventing lung cancer in current or former smokers with bronchial dysplasia.~     Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol~     may prevent lung cancer. It is not yet known whether inositol is more effective than a~     placebo in preventing lung cancer in smokers with bronchial dysplasia.~   "
212109|NCT00783991|"~     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap~     initiative to develop a computerized system measuring patient-reported outcomes in~     respondents with a wide range of chronic diseases and demographic characteristics. In the~     first four years of its existence, the PROMIS network developed item banks for measuring~     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical~     function, and social functioning. During the item banking process, the PROMIS network~     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses~     to refine the meaning, clarity, and literacy demands of all items. The item banks were~     administered to over 20,000 respondents and calibrated using models based on item response~     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were~     developed and implemented. The network has designed a series of studies using clinical~     populations to evaluate the item attributes, examine their utility as CATs, and validate the~     item banks. More information on the PROMIS network can be found at www.nihpromis.org.~      This study is designed to examine how differences in modes of data capture affect~     psychometric properties and score differences and to evaluate the consistency of these~     results across three PROMIS health domains: emotional distress-depression, fatigue, and~     physical function. Four modes of administration will be compared: interactive voice response~     (IVR) technology, paper and pencil questionnaire, personal computer, and personal digital~     assistant (PDA). A total of 800 patients will be enrolled from three diagnostic groups:~     chronic obstructive pulmonary disease (COPD), depression, and rheumatoid arthritis. The study~     will test for equivalence across modes of administration, with the hypothesis that there are~     no mode effects; if mode effects are found, their magnitude across modes will be estimated.~     This network project will result in an improved understanding of the effect of assessment~     mode on patient-reported outcome (PRO) data. Guidance from this project can help in planning~     future PROMIS activities beyond the present PROMIS program.~   "
212110|NCT00783978|"~     Interstitial lung diseases (ILD) in children represent a heterogeneous group of rare and not~     well defined disorders. Genetic abnormalities of surfactant proteins B (SFTPB) and more~     recently C (SFTPC) have been shown to be related to these pathologies. However, variability~     in the lung disease phenotype suggests the involvement of other surfactant-associated genes~     such as ABCA3 (ATP-binding cassette, sub-family A, member, 3). Thus, the aim of this project~     is: 1) to assess the prevalence of SFTPC mutation in children with chronic lung diseases, 2)~     to precise clinical and radiological features of children with SFTPC mutation, and 3) to~     identify environmental or genetic factors that may explain the extreme variability of this~     disease.~   "
212111|NCT00783965|"~     RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This randomized phase II trial is comparing two different schedules of topical~     tazarotene and topical placebo to see how well they work in treating patients with basal cell~     skin cancer and basal cell nevus syndrome on the chest.~   "
212112|NCT00783952|"~     The purpose of this study is to test a new way to measure the oxygen level in the mixed~     venous blood system (the system that carries blood collected from all over the body to the~     heart), which is a very important monitoring tool for the overall oxygen delivery to all our~     tissues. This new way measures the oxygen level in the mixed venous blood from outside the~     body, instead of measuring from the inside through a catheter (a thin, flexible plastic tube)~     that is placed by breaking the skin.~   "
212113|NCT00783939|"~     The purpose of this study is to prove the safety in normal conditions of useof the product~     Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).~   "
212114|NCT00783926|"~     The objectives of this study are to assess the dose-related safety and immunogenicity of six~     different dose levels of inactivated, Vero cell-derived reverse genetic reassortant~     A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will~     receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be~     drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body~     temperature will be measured daily for 6 days following vaccination. Injection site reactions~     and systemic reactions will be monitored throughout the entire 180 days of the study. Safety~     data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be~     reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to~     proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.~   "
212115|NCT00783913|"~     This study will determine if electrical brain stimulation during movement practice can~     improve the ability of stroke patients to reach for objects more than movement practice~     alone.~      People between 18 and 85 years old who have had a stroke may be eligible for this study.~     Participants are randomly assigned to one of two study groups: movement training with active~     (tDCS) or movement training with sham (tDCS).~      Participants will undergo 1-hour movement training and (tDCS) sessions twice a day, 5 days a~     week, for 3 weeks. For these sessions, subjects will sit in front of a computer screen that~     shows a target (round dots) and a cursor (a line). Participants will be instructed to move~     the cursor to various targets on the computer screen as fast and as accurately as possible,~     controlling the position of the cursor by moving their arm, which will rest on a mechanical~     device.~      Participants will receive real or sham (tDCS) during the movement training sessions. For~     (tDCS), electrode sponges soaked in tap water are placed on the scalp and forehead. A small~     electrical current is passed between the electrodes. The stimulation lasts 20 minutes.~      Patients will have the following tests four times during the study - 1) before starting~     movement training 2) (tDCS) during the course of training and (tDCS), 3) after completing~     training and (tDCS), 4) and 3 months after completing training and (tDCS):~      Functional magnetic resonance imaging (fMRI)~      Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to take pictures of~     the brain. Functional MRI (fMRI) shows what parts of the brain are used when a task is~     performed. For the test, the subject lies on a table that can slide in and out of the~     scanner. A computer screen can be seen from inside the scanner. During the scan, subjects may~     be asked to do the study task or to lie still for up to 20 minutes at a time.~      Movement and function tests~        -  Measurement of arm stiffness~        -  Moving the arms actively and against resistance~        -  Picking up objects and moving them as quickly as possible~        -  Performing daily living tasks like buttoning, dressing and walking~        -  Performing tasks while wearing a glove that monitors the position of the arm~        -  Completing questionnaires on ability to perform daily activities or other movements and~          level of tiredness~      Transcranial magnetic stimulation (TMS)~      TMS uses a magnet to stimulate the brain in way that is different from (tDCS). This study~     us...~   "
212116|NCT00783900|"~     The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous~     administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery~   "
212117|NCT00783887|"~     Primary ciliary dyskinesia is an inherited respiratory disease caused by various functional~     and ultrastructural abnormalities of respiratory cilia. The genetic heterogeneity underlying~     PCD is extremely important and only few genes are clearly implicated in PCD. Their mutations~     account for about 20% of patients. For all the other PCD patients, the genes responsible for~     their ciliary defect remain to be identify.~   "
212118|NCT00783861|"~     To demonstrate the absence of irritation potential (primary dermic irritability and cumulated~     dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina (Lactic~     Acid) Pocket BR.~   "
212128|NCT00783731|"~     Midazolam has been used in rapid sequence intubation for a long time, and the recommended~     dose is 0.1mg/kg. In some studies, however, the reduced dose has been used with the concern~     of hemodynamic instability. We would like to investigate that the low dose midazolam could be~     used rather than the standard recommended dose, and also compare it to the etomidate,~     recently used sedatives, with respect to the side effects and the easy performance of~     intubation.~   "
212119|NCT00783848|"~     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap~     initiative to develop a computerized system measuring patient-reported outcomes in~     respondents with a wide range of chronic diseases and demographic characteristics. In the~     first four years of its existence, the PROMIS network developed item banks for measuring~     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical~     function, and social functioning. During the item banking process, the PROMIS network~     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses~     to refine the meaning, clarity, and literacy demands of all items. The item banks were~     administered to over 20,000 respondents and calibrated using models based on item response~     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were~     developed and implemented. The network has designed a series of studies using clinical~     populations to evaluate the item attributes, examine their utility as CATs, and validate the~     item banks. More information on the PROMIS network can be found at www.nihpromis.org.~      The purpose of this research study is to learn about the experience and impact of having~     congestive heart failure (CHF). In particular, we hope to develop better questionnaires that~     can measure heart failure patients' quality-of-life.~   "
212120|NCT00783835|"~     The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the~     treatment on quality of life of long-acting methylphenidate in adult participants with~     Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in~     childhood and is characterized by inadequate levels of attention, hyperactivity and~     impulsiveness.~   "
212121|NCT00783822|"~     5-10% of breast cancer patients carry a mutation in the BRCA1 or BRCA2 gene. Genetic~     counseling and DNA testing are usually offered to selected patients after primary treatment~     has been completed (e.g. the first year after diagnosis). For women with a mutation in one of~     the two breast-ovarian cancer syndrome genes, chances of a second breast cancer are high, and~     therefore a proportion of these women may opt for preventive measures in addition to their~     immediate breast cancer treatment. Contralateral prophylactic mastectomy significantly~     reduces this risk, and is associated with a reduction in mortality.~      Genetic counseling and testing for breast cancer typically takes approximately 4-6 months to~     complete. However, some hospitals and laboratories are now able to generate test results~     within 3 to 6 weeks. This technology of rapid genetic testing creates new opportunities for~     providing both women and their treating surgeons with information potentially relevant for~     deciding between available treatment options, including type of surgery and adjuvant therapy.~      The study will focus on newly diagnosed breast cancer patients who, prior to receiving~     treatment, are identified as having at least a 10% risk of carrying a mutation in the BRCA1~     or BRCA2 genes.~      We will investigate whether women with a recent diagnosis of breast cancer make use of rapid~     genetic counseling when offered.~      Furthermore, we will investigate whether the process of genetic counseling (and subsequent~     DNA testing) has influence on the choice of treatment, and whether and how such rapid genetic~     counseling and testing (RGCT) affects levels of risk perception, cancer-related worries and~     distress, and decisional satisfaction.~   "
212122|NCT00783809|"~     Trauma patients are at risk for serious head trauma. The consequences of serious head trauma~     are often life altering. Currently, the only method available to rapidly assess the severity~     of head injury and need for neurosurgical intervention is the CT scan. This time consuming~     test requires transportation of a potentially unstable patient to the CT scanner.~      The investigators goal in traumatic brain injury is to identify early those patients who may~     require neurosurgical intervention. Brain swelling (elevated intracranial pressure) is~     transmitted to the eye and this can be measured with ultrasound. The investigators hypothesis~     is that this test will rule out significant elevations in intracranial pressure and perform~     as well as CT scan in doing this.~      The investigators study aims to demonstrate that ultrasound of the optic nerve is as good as~     CT scan in ruling out clinically significant elevations in pressure within the brain. After~     consent has been obtained, any trauma patient who has an indication to undergo CT scan of the~     brain will also undergo ultrasound of the eye. A radiologist will then review the CT scans to~     determine if signs of elevated intracranial pressure are present. The investigators hope to~     demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling~     out the possibility of elevated intracranial pressure.~      **Update August 2009** Currently, deferred consent has been obtained from our REB allowing us~     to defer consent for this intervention of minimal risk. As well, REB has also approved phone~     consent in the interim.~   "
212123|NCT00783796|"~     To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary~     Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with~     ischemic heart disease due to a maximum of two de novo native coronary artery lesions in~     small vessels, each in a different epicardial vessel.~   "
212124|NCT00783783|"~     Risperidone is an important medication used to treat children with psychiatric illnesses or~     neurodevelopmental disorders, such as autism. Despite excellent symptom control, the~     potential for side effects is worrisome. Treating these disorders is difficult because not~     everyone responds the same way to the same risperidone dose. One reason for this is genetic~     differences in how people break down the drug. Understanding these differences will help~     clinicians choose a dose and better predict the response so patients will be treated~     successfully with a lower risk for side effects. This study will research these genetic~     differences in children with psychiatric or neurodevelopmental disorders. Hypothesis: The~     inter-patient variability in risperidone pharmacokinetics and exposure, adverse events, and~     clinical response in patients with psychiatric or neurodevelopmental disorders is associated~     with identifiable pharmacogenetic factors, such as CYP2D6 single nucleotide polymorphisms~     (SNPs).~   "
212125|NCT00783770|"~     Mother's breast milk provides many benefits to babies with regard to development and improved~     health. We believe the simple sugars which make up these complex sugars in breast milk and~     are also found in the brain may be critical to normal brain development in term and preterm~     infants.~      Babies are exposed to these sugars by placental transport during pregnancy and through~     mother's breast milk after they are born. For the preterm infant, we do not know if breast~     milk gives enough of these sugars compared to what the baby gets during pregnancy.~      A maternal blood sample and blood samples from the baby's umbilical cord will provide us with~     background information for developing a supplement of special sugars that can be added to~     infant formulas to provide the amount that the baby usually gets during pregnancy and from~     breast milk.~   "
212132|NCT00783679|"~     The purpose of this study is to test the accuracy of a new noninvasive way to measure how~     much blood our heart pumps per minute. This new way measures the heart's pumping activity~     from outside the body, instead of breaking the skin and measuring it from the inside.~      Subjects will breathe normally through a mask while we record how fast and how much air they~     are breathing. We will have them re-breathe some of the air they breathed out by adjusting~     the ventilator. During this time, we will use the air breathed out to calculate how much~     blood per minute the subject's heart is pumping. We will also measure how much blood the~     heart is pumping at this time by injecting fluid into the catheter in the neck and then~     drawing about 1 teaspoon of blood from the catheters in the neck and arm. We will compare the~     calculated and measured values of the amount of blood pumped out of the heart for accuracy.~      After we complete this procedure, we will remove the mask and allow you to rest for 10-30min.~     Following the rest period, we will repeat the process and collect a second set of~     measurements. We will draw a total of 4 teaspoons of blood for the study.~      If you cannot comfortably breathe along with the ventilator, we will withdraw you from the~     study. If you want to stop taking part in the study at any time, let the study doctor know~     that you wish to withdraw. We will take off the mask, and your time in the study will end.~     This decision will not affect your regular medical care.~   "
212133|NCT00783666|"~     The purpose of this study is to demonstrate the absence of photoirritation and~     photosensitization potential of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).~   "
212134|NCT00783653|"~     In this study safety and tolerability of two dose levels of SU 11248 (sutent) with standard~     chemotherapy in patients with FLT3 mutated AML over 60 years will be evaluated.~   "
212135|NCT00783640|"~     To demonstrate the absence of photoirritation and photosensitization potential of the product~     Dermacyd Femina (Lactic Acid) Pocket BR.~   "
212136|NCT00783627|"~     Sickle Cell Disease (SCD) is the most prevalent genetic disease of haemoglobin.The underlying~     abnormality in the red blood cell (RBC) of SCD is the presence of abnormal sickle cell~     hemoglobin (HbS), which, when deoxygenated, becomes relatively insoluble, forms aggregates~     with other hemoglobin molecules within the RBC and causes rigid deformation of the cell.~     Acute pain vaso-occlusive crisis, strokes and acute chest syndrome are the main acute~     complications, sometimes life-threatening, often leading to organic and functional squeal.~     Although the common SS form of SCD is a unique gene disorder, the range of the clinical~     severity is remarkably wide and striking, suggesting that clinical polymorphism is due to~     modifier genes and environmental factors.Most of the research efforts have been focused on~     the biology of haemoglobin and of the red cells. Meanwhile, the complex pathophysiology of~     SCD is undoubtedly influenced by the many physiologic functions of the vascular wall. In line~     with this hypothesis are several reports of increased circulating levels of~     endothelium-derived surface molecules in SCD patients suggesting marked endothelial stress in~     SCD. Similarly, other processes that involve the endothelium, such as leukocyte adhesion and~     activation, may play a role in vascular occlusion. This accumulation of data raises the~     unanswered question of the mechanisms of endothelium maintenance and regeneration in SCD.~     Through these mechanisms, it is likely that function or dysfunction of the vascular~     endothelium contributes to the overall vascular pathobiology of this disease, which includes~     recurrent vaso-occlusions, stroke, leg ulcers, chronic organ ischemic damages, and~     neovascularizing retinopathy that affect nearly one-half (48%) of the surviving patients by~     the fifth decade.Thus, our groups have combined their respective clinical and biological~     expertises to test the hypothesis that SCD is a condition of specific endothelial stress and~     dysfunction upon chronic and Paracystic abnormal interactions with circulating cells and~     abnormal oxygen delivery to tissues. Specifically, we hypothesize that chronic endothelial~     stress with detachment of activated endothelial cells require increases mobilisation of the~     Endothelial Progenitor Cells (EPCs) that maintain endothelial homeostasis to avoid major~     thromboembolic events and vasospasm. Inappropriate mobilisation or maturation of the EPCs in~     SCD may participate to the severity of the disease.~   "
212137|NCT00783614|"~     The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy)~     and aspirin use on risk for cardiovascular disease among HIV infected persons.~   "
212138|NCT00783601|"~     The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in~     patients with chronic asthma.~   "
212139|NCT00783588|"~     The study is a Phase Ib extension trial that will assess the toxicity, tolerability, and~     safety of up to two repeated administrations of 1x10^8, 3x10^8, or 1x10^9 autologous~     Ad-ISF35-transduced CLL B cells given intravenously to patients with CLL who tolerated ISF35~     in the prior Phase I infusion trial at M.D. Anderson.~   "
212140|NCT00783575|"~     The purpose of this study is to look for the NOD2 gene in children with Inflammatory Bowel~     Disease (IBD) and their parents. We hope to understand this NOD2 gene better by determining~     whether children that have IBD have the NOD2 gene. In those with the NOD2 gene, we want to~     see if the type of gene abnormality predicts the nature of their disease and if the genetic~     information helps doctors decide what therapies and/or treatments to use for their patients.~     We also hope to explore the relationships between known serologic markers of IBD (ASCA,~     pANCA, ompC) and the clinical characteristics and course of children with IBD.~      About 1500 children and as many of their parents as possible will take part in this study.~     Children who are newly diagnosed with IBD as well as children that are being seen in the~     Children's Health System are eligible to participate in this study. We are looking for~     children 18 years old or younger to participate. If possible, we would also like both parents~     of the child to participate.~   "
212141|NCT00783562|"~     Childcare in nursery schools has been shown to be associated with an elevated prevalence of~     neck, shoulder, arm and low back disorders. The current evidence suggests that exercises seem~     to be the only effective preventive intervention. Thus the purpose of this study is to~     determine the effectiveness of an extension-oriented exercise program in preventing low~     back/neck pain and functional disability in nursery school teachers. In addition, the~     investigators also sought to identify the occurrence of musculoskeletal complaints in this~     category of workers.~   "
212142|NCT00783549|"~     This study is the first study in humans to assess the safety and tolerability of various~     doses of GSK1292263 alone, and taken with sitigliptan.~   "
212143|NCT00783536|"~     This is a randomized, open label, active-comparator, parallel design, outpatient, multicenter~     study being conducted in Mexico. Subjects with early active Rheumatoid Arthritis (RA) who~     have not received treatment with a Disease-modifying antirheumatic drug (DMARD) in the~     previous 6 months will be eligible for the study. Study subjects will be randomized into one~     of two treatments groups and receive either etanercept + methotrexate or standard~     non-biologic DMARD therapy.~   "
212177|NCT00783094|"~     This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the~     efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an~     open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese~     men with signs and symptoms of benign prostatic hyperplasia.~   "
212178|NCT00783081|"~     The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment~     of intermittent claudication.~   "
212144|NCT00783523|"~     Brain vascular malformations, including arteriovenous malformations (AVM), cavernous~     malformations (CVM) and aneurysms, are a source of life-threatening risk of intracranial~     hemorrhage. The etiology and pathogenesis are unknown. There is no medical therapy presently~     available. Prevention of spontaneous intracerebral hemorrhage (ICH) is the primary reason to~     treat brain vascular malformations. The goal of this study is to: begin pilot studies to lay~     the groundwork for future clinical trials to develop medical therapy to decrease ICH risk.~      Matrix metalloproteinases (MMPs) regulate the extracellular matrix in association with~     various hemorrhagic brain disorders. MMP-9 has been most consistently associated with~     vascular wall instability and hemorrhagic brain disorders. Doxycycline, a non-specific MMP~     inhibitor, may enhance vascular stability, thus reducing the risk of spontaneous hemorrhage~     in brain vascular malformations by decreasing MMP-9 activity.~   "
212145|NCT00783510|"~     This is a global registry, to evaluate the long-term safety of Humira® in patients with~     moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as~     recommended in the Humira® product label. Patients treated with MTX will be considered a~     reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms~     for 10 years from the enrollment date into one of the treatment arms.~   "
212146|NCT00783497|"~     High blood pressure is a common health problem among people in the United States. This study~     will examine the ways that stress and ethnicity play a role in the development of high blood~     pressure.~   "
212147|NCT00783484|"~     First in human study to evaluate the safety, tolerability, and pharmacokinetics of~     PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam,~     darunavir and maraviroc will also be evaluated.~   "
212148|NCT00783471|"~     To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for~     treating patients with the diagnosis of advanced Non-Small-Lung-Cancer~   "
212149|NCT00783458|"~     This was a one-day single dose trial conducted to compare patient's preference for Nasonex®~     (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2~     sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take~     one dose of the opposite medication. Questionnaires were given to each patient after each~     drug dose to evaluate patient product preference.~   "
212150|NCT00783445|"~     Black Americans with a family history of early heart disease tend to have a group of risk~     factors that can contribute to heart disease. These risk factors, which include excess body~     weight, high blood pressure, and high cholesterol, are known collectively as metabolic~     syndrome. This study will compare a community-based, coach-led exercise program to an~     individual, self-led home-based exercise program to determine which program is more effective~     at reducing the metabolic syndrome risk factors that can lead to heart disease.~   "
212151|NCT00783432|"~     The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine~     hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)~   "
212152|NCT00783419|"~     A retrospective review of women who came through the ER at SMH with a pelvic inflammatory~     disease (PID) or tubo-ovarian abscess (TOA) between 1995-2005. They were looking at people~     with this diagnosis to determine how they were treated, whether as inpatient or outpatient~     and whether they were treated with drugs and how were these given and also did they develop~     an abscess.~   "
212153|NCT00783406|"~     This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355~     in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are~     intended to explore the anticipated clinical dose range.~   "
212154|NCT00783393|"~     The primary purpose of the study is to evaluate the efficacy (overall response) and safety of~     temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28~     day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23~     day rest period) in patients with anaplastic astrocytoma at first relapse.~   "
212155|NCT00783380|"~     Evaluation of the immunogenicity and reactogenicity of two different formulations of~     commercially avail-able influenza vaccines in 4 different groups of immunocompromized~     outpatients (HIV positive patients, patients suffering from rheumatologic diseases and~     receiving treatment with immunosuppressive drugs and patients undergoing hemodialysis or~     continuous ambulatory peritoneal dialysis). The aim of the study was to investigate if the~     newest formulation of influenza vaccines (virosomal vaccines) offer a benefit in~     immunocompromized patients in comparison to an older subunit formulation.~   "
212156|NCT00783367|"~     Pre-clinical data and recently published clinical data suggest a synergistic effect between~     lenalidomide and dexamethasone. We hypothesize that a combination of~     lenalidomide-dexamethasone can overcome rituximab resistance. To determine the response rate~     to lenalidomide and dexamethasone plus rituximab therapy in subjects with recurrent small~     B-cell non-Hodgkin lymphoma who have had lymphoma progression within 6 months of being~     treated with rituximab alone or with a rituximab-containing regimen, we propose initial~     treatment with both drugs for two 28-day treatment cycles (Part I). After response assessment~     following two cycles of lenalidomide-dexamethasone, patients will enter Part II of the study.~     In Part II, patients will receive lenalidomide-dexamethasone and rituximab to evaluate the~     potential reversal of rituximab resistance as measured by response to rituximab and~     progression-free survival following rituximab.~   "
212157|NCT00783354|"~     This double-blind pilot study was conducted to establish the best way of using desloratadine~     treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an~     initial 4-weeks of daily treatment: prolonging systematic daily treatment or as needed (PRN;~     in the case of symptoms).~   "
212158|NCT00783341|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending~     doses of GAP 134 administered as 6-day continuous IV infusions to healthy subjects.~   "
212159|NCT00783328|"~     To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced~     malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese~     studies.~   "
212160|NCT00783315|"~     Many people who are obese also have high blood pressure, high cholesterol, or diabetes—all~     conditions that can increase the risk of heart disease. This study will evaluate two programs~     that aim to encourage weight loss among obese people who are at risk for developing heart~     disease.~   "
212163|NCT00783276|"~     The dopamine system is critical in modulation of reward and has been implicated in the~     initiation and maintenance of addiction (Volkow et al 2004). Medications that increase~     dopamine either directly or indirectly have been shown to have preliminary efficacy at~     reducing cocaine use in cocaine dependent subjects (Grabowski et al 2004a; Schmitz et al~     2008). A novel class of medications that has recently been shown to indirectly modulate~     dopamine function is adenosine A2A receptor antagonists (Fuxe et al 2007). Based on their~     effect on dopamine function it has been suggested that these compounds may be efficacious in~     the treatment of drug addiction (Ferre et al 2007c). Before clinical efficacy studies are~     undertaken, more basic research on the effects of adenosine A2A antagonists on brain function~     and behavior are warranted. The aim of this study is to examine the acute effects of a single~     dose of the selective adenosine A2A antagonist (SYN115, Synosia Therapeutics, Chemical name:~     4-Hydroxy-4-methyl-piperidine-1-carboxylic~     acid-(4-methoxy-7-morpholin-4-yl-benzothiazol-2-yl)-amide) on brain function and behavior in~     cocaine dependent individuals using functional magnetic resonance imaging (fMRI). To examine~     the effect of a single dose of SYN115 on brain function and behavior in cocaine dependent~     subjects.~      Hypotheses:~        1. SYN115 100 mg will increase brain activation in the dorsolateral prefrontal cortex~          compared to placebo in cocaine dependent subjects performing a working memory task.~        2. SYN115 100 mg will increase brain activation in the ventral striatum compared to placebo~          in cocaine dependent subjects performing a reversal learning task.~        3. SYN115 100 mg will reduce brain activation in the anterior cingulate gyrus and amygdala~          compared to placebo in cocaine dependent subjects performing a cocaine-word Stroop task.~   "
212164|NCT00783263|"~     A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the~     addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in~     participants treated with rosuvastatin alone and not at their National Cholesterol Education~     Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal~   "
212165|NCT00783250|"~     The aim of this study is to assess the effects on respiratory mechanics of one classical~     short-term bronchodilator (i.e., salbutamol) versus placebo, and to verify the hypothesis~     that the addition of another bronchodilator (i.e., anticholinergic) may induce a further~     improvement on the work of breathing of stable COPD patients.~   "
212166|NCT00783237|"~     This was a single-dose study to determine the time it takes for mometasone furoate nasal~     spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible~     were exposed to ragweed pollen for 3 hours on one or two occasions. Patients who experienced~     adequate symptoms during the pollen exposure phase came back for a Treatment Phase visit.~     During the Treatment Phase visit, patients were exposed to ragweed pollen for 2 hours and~     then received either mometasone or placebo nasal spray. Symptom evaluations began on the~     patients every hour for the next 11 hours.~   "
212167|NCT00783224|"~     This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of~     perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo~     mometasone, active fluticasone, or placebo fluticasone.~   "
212168|NCT00783211|"~     This was a randomized, double-blind, parallel-group, multicenter study that used both an~     active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily~     during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1~     ratio.~   "
212169|NCT00783198|"~     This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH~     39641/MK-3641) compared with placebo in participants with ragweed-induced rhinoconjunctivitis~     over a one-year period. It is expected that ragweed allergic participants on one of the~     active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and~     require less allergy rescue medications during ragweed pollen season.~   "
212170|NCT00783185|"~     Intention of the study is to examine, if the symptomatology of dual diagnosis patients is~     less severe after a special indication training for reduction of cannabis consumption in~     comparison to unspecified trainings.~      Point of interest is psychopathology and consumerism.~   "
212171|NCT00783172|"~     It is hypothesized that OGF biotherapy may be safely administered in combination with~     gemcitabine to individuals with unresectable pancreatic cancer. The study includes two aims,~     the first is to evaluate the safety and toxicity of the combination of OGF and gemcitabine~     chemotherapy. The second aim of the trial is to study the efficacy of OGF and gemcitabine~     when used in combination.~   "
212172|NCT00783159|"~     This intervention study tests training methods to stabilize or improve functionality in the~     high risk group of prefrail elderly persons.~   "
212173|NCT00783146|"~     This was a randomized, double-blind, parallel-group, multicenter study that used both an~     active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily~     during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1~     ratio.~   "
212174|NCT00783133|"~     This was a crossover study designed to see if patients with seasonal allergy symptoms~     preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or~     Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given),~     followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients~     were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.~   "
212175|NCT00783120|"~     Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients~     and their relatives. Despite treatment with second generation antipsychotics, negative~     symptoms and cognitive impairment often persist and determine an unfavourable course~     including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation~     (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing~     antipsychotic treatment was demonstrated to be safe and was associated with improvement in~     negative symptoms in the majority of the small placebo-controlled trials.~      The primary objective of the trial is to investigate the efficacy of high-frequency rTMS~     (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia~     compared to sham stimulation (placebo).~   "
212176|NCT00783107|"~     This is a randomized, double-blinded, Phase I dose escalation-deescalation protocol (DEP) of~     cyclosporine inhalation solution in patients with Gold Stage III chronic obstructive~     pulmonary disease.~      The purpose of the study is to evaluate the safety and effectiveness of aerosolized~     Cyclosporine in treating COPD.~      The specific aims of the study are:~        1. To identify the short term (28 day) safety profile of CyIS immunotherapy in severe COPD~          (GOLD III) patients with particular attention to airway reactivity and infection risk.~        2. To identify the pharmacokinetic-pharmacodynamic relationship of CyIS using peripheral~          blood markers of an adaptive immune response as endpoints in subjects with severe COPD~          (GOLD III) treated short-term.~      Subjects between 45 and 70 years of age with a confirmed diagnosis of COPD, Gold Stage III,~     and meet all the study requirements, will be enrolled in this study. A total of 24 subjects~     of either sex will be enrolled in this study. A total of 4 subject cohorts (n=6) will~     participate in the protocol.~   "
212179|NCT00783068|"~     Rationale: The vagus nerve exerts an anti-inflammatory effect in in vitro and animal~     experiments. This 'vagal anti-inflammatory pathway' is mediated by the nicotinergic α7nACh~     receptor that can be selectively stimulated by GTS-21. Activation of the cholinergic~     anti-inflammatory pathway via vagus nerve stimulation or α7nAChR agonists improves outcome in~     animal models of endotoxemia, sepsis and experimental arthritis. Up to now, the~     anti-inflammatory effects of oral administration of GTS-21 in humans in vivo has not been~     investigated.~      Objective: Primary aim: to investigate the anti-inflammatory effects of oral administration~     of GTS-21 on the inflammatory response in the human endotoxemia model and the subsequent~     inflammation-induced subclinical organ dysfunction. Secondary aim: to measure the effect of~     LPS administration in the absence or presence of GTS-21 in human volunteers on vagal nerve~     activity measured by heart rate variability analysis.~      Study design: Double-blind placebo-controlled randomized cross-over intervention study in~     healthy human volunteers during experimental endotoxemia.~      Study population: Non-smoking healthy male volunteers, age 18-35 yrs Intervention: Subjects~     will be tested in a cross-over design in 2 separate sequential sessions, 2-4 weeks apart. A~     total of 12 subjects will be randomly assigned to one of two dosing groups in a 1:1 ratio:~     GTS-21 followed by Placebo n=6, Placebo followed by GTS-21 n=6. Subjects will receive 150mg~     GTS-21 or placebo orally tid 3 days before LPS injection and an oral dose of 150 mg GTS-21 or~     placebo the morning of the day of LPS administration (07:00 AM). Subjects will then receive~     an oral dose of 150 mg GTS-21 or placebo at 08:00 AM and another oral dose of 150 mg GTS-21~     or placebo at 1 hour before LPS administration (t=0). Before LPS injection, prehydration will~     be performed by infusion of 1.5 L 2.5% glucose/0.45% saline solution in 1 hour. One hour~     after the last dose of GTS-21 or placebo, LPS derived from E coli O:113 will be injected (2~     ng/kg iv in 1 minute). There will be a 14 day washout period for patients in all groups. The~     last group of subjects will be subjected to an identical dose of LPS and placebo at two~     different moments 2-4 weeks apart to obtain time controls.~      Main study parameters/endpoints: Main study endpoint is the concentration of circulating~     cytokines after LPS in the absence and presence of GTS-21.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: A medical interview and physical examination is part of this study.~     Approximately 350 ml blood will be withdrawn and urine will be collected. There will be mild~     discomfort associated with participation in this study, as LPS induces flu-like symptoms for~     approximately 4 hrs. GTS-21 was found to be well tolerated at a dose of 150 mg three times~     daily (450 mg/day).~   "
212180|NCT00783055|"~     The purpose of this study is to assess the status of perceived autonomy and to evaluate the~     effectiveness of individually tailored programmes on perceived autonomy in physically frail~     older people living in nursing homes.~   "
212181|NCT00783042|"~     The aim of this study is to investigate whether the non-invasive ultrasound method for~     assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow~     reserve (TTDE-CFR), can be used to measure drug effects.~   "
212182|NCT00783029|"~     The purpose of this research study is examine the response of the blood vessels in the eye to~     a light flicker stimulus using the Dynamic Vessel Analyzer (DVA) on two separate days in~     healthy individuals. The DVA uses an instrument which is used during routine eye~     examinations. The hypothesis of the study is that the changes in eye's blood vessel will be~     similar between the two visits; thus establishing reproducibility of the measurements for~     future comparisons to individuals with stroke or heart disease. In addition, this study will~     compare the eye's blood vessel responses to responses of the blood vessels in the arm using~     Doppler ultrasound.~   "
212183|NCT00783016|"~     The pain control in surgical abdomen has been in debate in masking the correct diagnosis. We~     would like to investigate the effect of pain control on the diagnostic accuracy of surgeon in~     suspicious appendicitis patients.~      We would give morphine or placebo to the patients suspected of appendicitis randomly and in~     double-blinded manner, and then surgeons would exam the patient and give the impression for~     the possibility of the appendicitis(grading 1 to 4).~      With this grading, we compare these impression between two groups.~   "
212184|NCT00783003|"~     GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary~     Disease. Development of these two inhaled drugs as a combination therapy would have potential~     for improved patient benefit as they both work through different mechanisms and the combined~     bronchodilatory effect might be additive. This study will look at the this combination, for~     the first time, in healthy Japanese subjects.~   "
212185|NCT00782990|"~     Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress~     incontinence (SUI).~      Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive~     35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district~     general hospital at Leganés (Madrid), Spain.~      Intervention: 24 patients randomised to TVT and 25 to CS.~   "
212186|NCT00782977|"~     The purpose of the study is to evaluate the effectiveness of continuous oxygen provided by~     nasal prongs in preventing or delaying hypoxemia during the apneic period that occurs after~     induction of general anesthesia. This will be evaluated by measuring the arterial oxygen~     tension (PaO2).~      The study will also evaluate whether there is any difference in PaO2 when using nasal prongs~     with flow rates of 5 L/minute versus 10 L/minute of oxygen.~   "
212187|NCT00782964|"~     Observational, non-interventional, longitudinal, prospective,multicenter, open label (No~     treatment is involved). 3 assessment will be carried out . The 1st one will be on baseline,~     the 2sd one after a significant change in pharmacological treatment and 3rd one after a~     second significant change in pharmacological treatment. If there isn´t any significant change~     in therapeutic plan a control assessment will be carry out in week 10th and 24th. A~     significant treatment change is defined as a change in SSRI/SNRI, to add another SSRI/SNRI or~     a augmentation treatment added to SSRI/SNRI. The primary objective is to describe~     therapeutical strategies (antidepressant change, association with another antidepressant or~     association with another treatment) in the management of patients with MDD with incomplete~     response or intolerance to an antidepressant after a first or a second failure; and when the~     psychiatrist decide a change of strategy. Secondary objectives include: 1 - To describe the~     clinic profile of depressive patients with incomplete response or intolerance to an~     antidepressant after a first or a second failure; 2- To describe the profile of patients~     based on therapeutic strategies used and number of therapeutic strategies; 4- Evaluate the~     use of health resource due to lack of fast onset of action, and social cost (productivity,~     care givers…); 5 - To associate clinical variable with therapeutic action by psychiatrist.~   "
212188|NCT00782951|"~     Patients will receive a single intravenous (IV) infusion administered over 3 minutes of~     either ORG 28611 (SCH 900111), 0.12 mg/kg morphine sulphate, or placebo, within 6 hours after~     dental surgery, when they experience moderate to severe dental pain. Patient will then be~     evaluated with pain assessments at Baseline, 5, 10, 15, 30, 45, 60, and 90 minutes; and 2~     through 8 hours or before rescue medication is needed.~   "
212189|NCT00782938|"~     Drugs with anticholinergic potential increase the risk of postoperative transient and~     persistent cognitive dysfunction especially in cardiac patients. The investigators main goal~     is to identify preoperative risk factors and to monitor postoperative patients' state in~     relation to SAA activity and bilateral BIS-EEG changes.~   "
228312|NCT00568672|"~     Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major~     depression who had a response with additional olanzapine to an antidepressant.~   "
212190|NCT00782925|"~     At Lyon University Medical Center, back problems are the leading cause of sick leave. The~     course of lower back pain is usually relatively short (recovery occurs within 4 to 6 weeks in~     90% of cases). However, about 5-10% develop chronic lower back pain. Although this is a~     relatively small group, the economic consequences are enormous (accounting for 70 to 80% of~     the total cost of lower back pain).~      Nowadays, some very general training sessions are offered to workers at Lyon University~     Medical Center, irrespective of their lower back pain status. These very general training~     sessions are mostly preventive and primary in nature (like back school program) despite the~     fact that these people already have a history of lower back pain, the main risk factor of~     recurrence and chronic pain.~      Since the 1980, some multidisciplinary functional restoration programs have been advised as a~     strategy for secondary and tertiary prevention of lower back pain.~      The purpose of this randomized controlled trial is to assess the effectiveness of physical~     exercise combined with an educational program and self-led exercise for Lyon University~     Medical Center workers with lower back pain. We hope this intervention will reduce the risk~     of recurrence and chronic lower back pain.~   "
212191|NCT00782912|"~     Postpartum anemia (PPA) and Postpartum depression (PPD) are common afflictions affecting~     women after childbirth. Both disorders have a significant impact on women's health and~     functional status. Despite common symptoms and characteristics, a link between these entities~     has not been adequately studied. The objective of this study is to determine whether~     postpartum anemia is an independent risk factor for the development of postpartum depression.~     This prospective cohort study will include all women delivered by elective term cesarean~     delivery. Hemoglobin and iron levels will be measured, standardized questionnaires for~     assessment of PPD, functional status and lactation will be administered before discharge and~     at 3 & 6 weeks post partum. Hemoglobin levels at each time point will be analyzed for~     correlation with depressive symptoms, functional status and lactation success.~   "
212192|NCT00782899|"~     Observational, non-interventional, longitudinal, prospective,multicenter, open label (No~     treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. The~     primary objective is to asses evolution of subjective well-being and depressive symptoms in~     schizophrenic patients for six months after an acute episode treated in outpatient~     psychiatric units. The primary endpoint is: Total score in Subjective Well-being under~     Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment~     after 6 months vs baseline. Secondary objectives include: To evaluate the relationship~     between subjective well-being and psychopathology, subjective clinical global impression,~     adverse events and compliance of treatment. Also to compare the clinical global impression of~     psychiatrist and patient. In addiction to know the clinical, social and demographic factors~     involve in the subjective well-being and patient clinical global impression.~   "
212193|NCT00782886|"~     Image-guided surgery essentially describes the interactive use of medical images during a~     surgical procedure and is often referred to as a global positioning system (GPS) for~     surgery.~   "
212194|NCT00782873|"~     The purpose of this study is to evaluate the safety of propofol-based,~     gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper~     endoscopy.~      The investigators aim to test the hypothesis that it is safe to use balanced-propofol,~     gastroenterologist-administered sedation in obese patients.~   "
212195|NCT00782860|"~     The main purpose of our study was to which determine factors, those measured by ultrasound~     and also demographic and clinical factors (age, number of previous pregnancies, abortions and~     deliveries) predict outcome of medical treatment for early pregnancy failure. Our hypothesis~     was that gestational sac volume predicts outcome of medical treatment for early pregnancy~     failure.~   "
212196|NCT00782847|"~     This study is designated to evaluate the effect of a patients' educational program called~     DiaNe® for consultation and support people with diabetic kidney disease in an early stage.~     The aim of the study is to examine if the program is suitable to stop deterioration of kidney~     function and to maintain or improve glycemic control. The consultation and support program~     DiaNe® substantially contributes to a better understanding of the affected clients for this~     complex clinical picture, allows them for specific interventions and creates the rationale~     for an active therapeutic relationship.~   "
212197|NCT00782834|"~     This is a phase II study of Nilotinib for patients with advanced GIST that cannot be~     surgically removed. Patients are candidates for the study if their tumors have progressed on~     imatinib and sunitinib or if they were intolerant to these drugs. Patients may have received~     other investigational therapies as well. We are testing the benefit of nilotinib in advanced~     GIST looking at the length of time disease is controlled as well as the response of the~     disease to the drug.~   "
212198|NCT00782821|"~     The purpose of this research study is to find out the effects of adding B lymphocyte~     modulating agents in patients at risk for rejection receiving an anti-rejection~     (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and~     corticosteroid therapy.~   "
212199|NCT00782808|"~     Sixty HIV participants will be enrolled and stratified by PBMC HIV DNA levels, either high~     (greater than or equal to 5000 copies/106 cells) or low (less than 5000 copies/106 cells).~     Individuals will be enrolled into each group until filled. Screening PBMC HIV DNA levels will~     be performed at SEARCH in real-time with less than one-week turn around time. All individuals~     will intend to initiate ARV due to meeting MOPH guidelines for such. The protocol team will~     work with the primary care physician to facilitate initiation of standard ARV care; however,~     initiation of ARV is not a requirement of the study and ARV will not be provided by the~     study.~   "
212200|NCT00782795|"~     The purpose of this study is to determine if study drug (Pioglitazone) treatment will improve~     pre-diabetes (insulin resistance) or ealy diabetes and improve clinical symptoms (pain) or~     laboratory evidence of chronic pancreatitis.~      The goal of the investigators is to gather information from this study to help gain~     understanding of a potential therapy for chronic pancreatitis.~   "
212201|NCT00782782|"~     Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular~     responses. The aim of this study is to characterize these differences. Our hypothesis is,~     that there are differences in vascular responses between healthy subjects and patients with~     CHF.~   "
213551|NCT00764712|"~     A randomized trial to compare three insulin-titration protocols for tight glycemic control in~     surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath)~     protocol, and an enhanced model predictive control algorithm (eMPC)~   "
212202|NCT00782769|"~     This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete~     the DR-OXY-301 study are eligible to participate. The duration of this extension study will~     be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including~     blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As~     in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4~     weeks. Subjects will also be required to keep a daily record of the number of times and the~     total amount of time the ring was outside the body each day and the reason for voluntary~     removal.~   "
212203|NCT00782756|"~     The purpose of this study is to test the safety of a new plan for treating glioblastoma. The~     usual first treatment for glioblastoma is to give focused radiation over 6 weeks in~     combination with a chemotherapy called temozolomide. In this study the radiation will be~     given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also~     be given. Our idea is that this treatment plan may attack both the tumor and the blood~     vessels feeding the tumor more effectively. This study will look at what effects, good or~     bad, this approach has on the patient and the tumor.~   "
212204|NCT00782743|"~     In this open, prospective, non-randomised, parallel group, unicentric pilot-study will be~     compared the progress of valvular and coronary calcification with regard to the therapy with~     either acetyl-salicylic acid or phenprocoumon. The progress of calcification is documented by~     comparison of cardial stratified computed tomography. It is supposed that treatment with~     phenprocumon leads to increased coronary and valvular calcification as well to decreased~     blood levels of carboxylated matrix-GLA-protein~   "
212205|NCT00782730|"~     This will be a descriptive study measuring the post—void residual of patients in the third~     trimester and postpartum. Also, bladder scan values will be compared to the amount of urine~     obtained from a Foley catheter to determine the accuracy of the bladder scanner in the third~     trimester and postpartum.~   "
212206|NCT00782717|"~     The purpose of this study is to determine whether nepafenac is safe and effective for~     reducing the incidence of macular edema following cataract surgery in diabetic retinopathy~     patients.~   "
212207|NCT00782704|"~     The aim is to develop and validate a morbidity index for postoperative complications in~     patients undergoing visceral surgery.~   "
212208|NCT00782691|"~     Various methods of FDG-PET signal segmentation will be validated by correlation of~     histopathologically measured tumor dimensions in lymph node dissection specimens of~     head-and-neck cancer patients.~   "
212209|NCT00782665|"~     This study is designed to demonstrate that women in labor become infected without exhibiting~     any clinical signs or symptoms of infection.~   "
212210|NCT00782652|"~     This study is designed to better understand the effects of nitric oxide, a gas for~     inhalation, on patients with right ventricular infarction.~   "
212211|NCT00782639|"~     The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN)~     following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque~     320) in patients with moderate-to-severe chronic kidney disease and diabetes mellitus~     undergoing cardiac angiography.~   "
212212|NCT00782626|"~     The purpose of this research study is to learn if the study drug RAD001 can shrink or slow~     the growth of low-grade gliomas. Additionally, the safety of RAD001 will be studied. RAD001~     is a drug that may act directly on tumor cells by inhibiting tumor cell growth and~     proliferation.~   "
212213|NCT00782613|"~     The primary objective of this study will be to evaluate the efficacy of topical ALT-2074~     applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.~      The secondary objective will be to evaluate the safety of topical ALT-2074 applied twice~     daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.~      Tertiary objectives will be to provide visual documentation of the improvement of psoriatic~     plaques treated with ALT-2074 using digital photography, and to determine the extent of~     systemic absorption of topically applied ALT-2074 based on a pharmacokinetic measurement of~     blood concentration.~   "
212214|NCT00782600|"~     This study is to test the idea that a controlled release formulation of CE-224,535 may allow~     for less frequent dosing and exposure to lower levels of drug than an immediate release~     formulation.~   "
212215|NCT00782587|"~     The purpose of this research study is to test the safety and tolerability of an experimental~     drug, Chemophase, a combination of recombinant human hyaluronidase, (an investigational~     synthetic enzyme also known as rHuPH20), and mitomycin (MMC) in the treatment of superficial~     bladder cancer when instilled intravesically immediately after TURBT (transurethral resection~     of bladder tumor).~   "
212216|NCT00782574|"~     A Phase I study to assess the safety and tolerability of AZD2281 in combination with~     Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to~     establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with~     advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled.~   "
212217|NCT00782561|"~     The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered~     over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental~     glomerulosclerosis (FSGS).~   "
212218|NCT00782548|"~     The primary objective of this study was to compare the single-dose relative bioavailability~     of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc. (AVINZA®) 30~     mg morphine sulfate sustained-release capsules in healthy adult volunteers under fed~     conditions.~      The secondary objective of this study was to evaluate the adverse events associated with each~     of these 2 different morphine sulfate modified-release commercial formulations~   "
212219|NCT00782535|"~     The purpose of this study is to characterize the dose-response profile of peak and trough~     FEV1 after single dose administrations of carmoterol in patients with COPD.~   "
212260|NCT00781989|"~     This is a prospective, observational study designed to look at ultrasound images of the joint~     at baseline and over time, and investigate whether there is a correlation between ultrasound~     images and progression of disease. The researchers wish also to see if ultrasound can be used~     as a tool to predict progression of Rheumatoid Arthritis in patients with early disease who~     have not taken biologics therapy. In addition, the researchers wish to investigate whether~     peripheral blood biomarkerscan be identified that predict the progression of erosive~     disease in early rheumatoid arthritis, with the intention of testing the most promising~     biomarkers in future clinical trials.~   "
212220|NCT00782522|"~     In the first part of the the study two new outcome measurements (force reproducibility and~     subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be~     assessed.~      In a second part of the study 60 patients will be randomly allocated to two groups. Group A~     (n=30) will perform a traditional training program and group B (n=30) will perform an~     eccentric training program.~      Before the onset of the training programs, pain, function, maximal force, range of motion,~     subacromial space and force reproducibility will be assessed. Both training programs will be~     accomplished at home. The first six weeks there will be an appointment with the therapist~     once a week to explain, correct and when necessary, aggravate the exercises. The next six~     weeks these appointments will be diminished to once every two weeks.~      After 6 and after 12 weeks of training the patients will be reassessed for all the~     parameters.~   "
212221|NCT00782509|"~     This primary objective of this study is to compare two doses of BI 1744 CL inhalation~     solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic~     obstructive pulmonary disease (COPD).~   "
212222|NCT00782496|"~     The purpose of this study is to evaluate if the meal marker and reminder feature of the~     Contour meter along with education maintains or increases frequency of testing blood sugar~     after meals and enables behavioral changes that may lead to improvement in glycemic control.~   "
212223|NCT00782483|"~     Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work.~     Only about 10% of PWS can be completely cleared. The research team believes that the~     investigators can improve the response of PWS to laser therapy by using a computer program~     that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The~     purpose of this study is to test the validity of this computer program. Personalized~     Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser~     treatment of PWS.~   "
212224|NCT00782470|"~     Understanding how often the bleeding events occur in the subjects who voluntarily decide to~     switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also~     look into the consequences of switching treatment in QoL (quality of life), development of~     target joints, activity level and reasons that might influence the desire to switch.~   "
212225|NCT00782457|"~     The aim of this study is to compare laparoscopic versus open approach on the surgical~     treatment of mid and low-lying rectal cancer, both performed by the same surgical team with~     experience in open colorectal surgery and advanced laparoscopic surgery, assessing~     preoperative and anatomopathological results and long-term outcome.~   "
212226|NCT00782444|"~     Project summary:~      Background: Computer navigation in knee replacement surgery is increasingly being used around~     the world, but the documentation of its usefulness is lacking. In order to critically~     evaluate this new surgical method, we want to perform a prospective, randomised clinical~     trial.~      Goal: We evaluate the need for these highly advanced techniques in knee replacement surgery,~     and the cost-effectiveness. Long term outcome for the patients will be predicted by using the~     radiostereometric analysis (RSA). Also, data from the Norwegian arthroplasty register will~     indicate any difference in long term survival of the implant. If there are any differences in~     the functional outcome or complication rate, between the two groups, this will be detected in~     this trial.~      Method: Patients age 50 through 85 years old, with gonarthritis, in need of knee replacement,~     are included in the trial. Radiostereometric analysis (RSA), CT-scans, X-rays, clinical~     evaluation score systems and laboratory measures are used in the evaluation process. A~     cost-effective analysis is performed based on data from Norwegian life tables, data from~     SINTEF and from the Norwegian arthroplasty register. Data from the Norwegian arthroplasty~     register will be statistically analysed separately for all knee replacements done with~     computer navigation in Norway in the last 5 years. Four Norwegian hospitals will collaborate~     in this trial (Haukeland university hospital, Haugesund hospital, Haugesund sanitetsforenings~     hospital for rheumatic diseases and Lovisenberg diakonale hospital) and patients are~     recruited from all four hospitals.~      Scientific impact/challenges: This trial will probably have great impact since good evidence~     supporting the use of computer navigation in knee surgery is lacking. It is important for the~     patient to be confident that he/she receives the best treatment, and it is important for the~     health care providers and funding authorities to have clear evidence when choosing between~     two different treatment techniques, in order for the patient to benefit.~   "
212227|NCT00782431|"~     The purpose of this study is to demonstrate the effectiveness (seroprotection and~     seroconversion as measured by the hemagglutination inhibition [HI] assay) of an~     investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years~     of age and older. Subjects will be randomized in a double-blind fashion to receive a single~     intramuscular injection of either the investigational vaccine or a licensed egg-derived~     seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI~     antibody titers on Days 0 and 21, body temperature and injection site reactions will be~     monitored daily for 7 days. In addition, subjects will be monitored for adverse events and~     rises in body temperature until Day 21 and again until Day 180.~   "
212228|NCT00782418|"~     This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for~     assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.~   "
212229|NCT00782405|"~     The purpose of this study is to examine the effects of (a) quetiapine XR and (b) mirtazapine~     on sleep when given as an antidepressant (monotherapy). We hypothesize that (a) quetiapine XR~     has an immediate and lasting positive effect on sleep in depressed patients which does not~     differ from the impact of mirtazapine on sleep in this group of patients; (b) in the context~     of a secondary objective, we expect an antidepressant effect of quetiapine XR which is~     equivalent to that of mirtazapine.~   "
212230|NCT00782392|"~     We are developing an oral supplement of carbohydrates to be added to infant formulas in order~     to improve brain development, immune function, and overall health of infants and children.~     After a careful review of what is known about these sugars, there is very little information~     regarding their use in infants and children, although there is some information in adults and~     animals.~      Many of these sugars have been used in a glyco-nutritional supplement in adults and children,~     with minimal or no reported side effects.~      We are developing a custom blend of important individual sugars, and need information~     regarding their dosing and blood concentrations following oral intake of the carbohydrate~     supplement. Timed blood samples following the carbohydrate supplement will provide us with a~     better understanding of the most effective dose and the metabolism of these sugars in adults.~     This will give us the preliminary information we need for developing an oral supplement of~     special sugars that can be added to infant formulas to help improve brain development and~     immune function in infants and children.~   "
212261|NCT00781976|"~     PK, safety study of AZD7295 in HCV carriers~   "
212439|NCT00779545|"~     This is a multicenter, randomized, double-blind within the dose level, parallel group~     comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to~     examine the minimal effective dose, the recommended dose, and the dosing regimen.~   "
212231|NCT00782379|"~     RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a~     donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps~     stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted~     cells from a donor can make an immune response against the body's normal cells. Giving~     high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after~     transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works when given~     together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil,~     and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.~   "
212232|NCT00782366|"~     This proof-of-principle clinical trial at Mayo Clinic studies how patients and their~     physicians understand and utilize predictive genetic risk assessment. A critical goal of this~     clinical trial is to understand how individual patients and their doctors perceive and~     respond to genetic risk information that is largely uncertain.~   "
212233|NCT00782353|"~     The purpose of this study is to investigate the safety, tolerability, and antiviral activity~     of ANA598 in patients with genotype-1 chronic hepatitis C infection.~   "
212234|NCT00782340|"~     The purpose of this study is to see whether droxidopa is effective in treating symptoms of~     neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic~     Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta~     Hydroxylase deficiency.~   "
212235|NCT00782327|"~     To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth~     in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of~     losartan will be compared to placebo. Losartan or placebo will be added to the treatment~     regimen in a two-step up-titration scheme over 2 weeks. Start doses of Losartan will be 25 mg~     for subjects under 50kg of weight and 50mg if the weight is over 50kg. Uptitration will be~     guided by the tolerance of the drug by the patients. Patients will be contacted by phone call~     for assessment of side-effects before second step of uptitration.~      Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if~     the weight is over 50kg~   "
212236|NCT00782314|"~     We want to evaluate efficacy of Symbicort® Turbuhaler® (formoterol/budesonide) therapy for~     asthma in real life conditions. For this purpose we will include both patients that are~     treated with Symbicort® Turbuhaler® the classical maintenance only treatment approach as~     well as those treated with the SMART approach.~   "
212237|NCT00782301|"~     Confirm the safety of maraviroc when used as a component of combination antiretroviral~     therapy in HIV and Hepatitis co-infected patients.~   "
212238|NCT00782288|"~     This study will measure the inflammatory effects of digitoxin on IL-8 and neutrophil counts~     in induced sputum in stable Cystic Fibrosis (CF) patients and the pharmacokinetics of~     digitoxin in serum.~      Funding Source-FDA OOPD~   "
212239|NCT00782275|"~     This is a single-arm phase II trial evaluating the combination of avastin and temsirolimus in~     patients with metastatic renal cell cancer (RCC) including both histologically confirmed~     clear cell (cc) or non-clear cell (ncc) subtypes. Patients must have experienced disease~     progression or intolerable toxicity with a vascular endothelial growth factor (VEGF)-targeted~     tyrosine kinase inhibitor (TKI) (e.g. sorafenib, sunitinib, pazopanib). Only 2 prior VEGF~     therapies are allowed. The purpose of this research study is to evaluate efficacy of the~     combination against an historical control. Temsirolimus has been approved by the Food and~     Drug Administration (FDA) in the treatment of renal cell carcinoma. Avastin has been approved~     by the FDA for other types of cancers but not renal cell carcinoma.~   "
212240|NCT00782262|"~     Obesity is a growing epidemic and is associated with an increased risk of heart attack and~     stroke. The investigators know that obesity leads to abnormalities in how the blood vessels~     and the heart function and that these abnormalities are an important cause of this increased~     risk in obese individuals. While improvements in these abnormalities have been reported with~     marked weight reduction (eg surgery) and lifestyle changes including exercise training, it is~     not clear that these abnormalities can be substantially reversed with standard dietary~     interventions. Additional information is needed regarding the degree of weight loss required,~     the time course of these improvements, nor the mechanisms. All of these have major~     implications for the potential role of weight loss in the management of these patients.~      The investigators will assess the effects of dietary induced weight loss in both the short~     and long term on the function of blood vessels and the heart, and the relationship of any~     changes with markers of inflammation that are present in obesity.~      By understanding the factors that are important in reversing these abnormalities in obesity~     the investigators will be better to identify and reduce heart attack and stroke in obese~     individuals in the future.~   "
212241|NCT00782249|"~     Patients with refractory epilepsy who are candidates for a treatment with vagus nerve~     stimulation will be prospectively randomized into 3 arms with different vagus nerve~     stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during~     outpatient clinic visits, within the normal clinical practice.~   "
212242|NCT00782236|"~     The primary objective of this study is to evaluate the implant stability at the time of~     abutment placement on implants placed in healed extraction sockets treated with Straumann~     BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).~   "
212243|NCT00782223|"~     Research Protocol Assessment of Hip, Spine and Lower Limbs Digital Radiograph Measurements in~     Pediatric Population: using PACS integrated Computer Software (TraumaCad from OrthoCrat ™).~      Introduction The integration of the PACS system into many medical institutions created a~     plethora of digital measurements to assess anatomic and deformity parameters for torso and~     limbs.~      A number of commercial digital software is being offered to supply the medical practioner~     with tools to assess normal and pathological bony architecture land marks.~      The relevant architecture of the pelvis (hip joint), spine and the length and alignment of~     lower limbs may be measured using these digital software's.~      The validity and accuracy of digital work in comparison to conventional radiographs has been~     studied recently, mainly with lower extremity axial alignment, the digital length and~     anatomical angles measurements were found to be more reliable in terms of intra observer~     reliability than conventional radiographs (1, 2).~      Study purposes~        1. To compare the, accuracy and reliability of specifically designed digital software~          (TraumaCad from OrthoCrat ™) measurements using wizard guidance, to those produced by~          using the tool bar (ruler and angle guide tools) of the DICOM folder.~        2. To assess intra and inter observer reliability of the TraumaCad software for different~          pediatric orthopaedics conditions.~           Methods *Twenty hip joins radiographs (AP views) of patients who suffer from Cerebral~          Palsy (10) and Developmental Dysplasia of the Hip (10) will be measured using the~          TraumaCad software hip joint wizard, and than again using basic tools of the DICOM~          folder.~           **Twenty spinal scoliosis radiographs (AP and Lat views) will be measured using the~          TraumaCad software templates.~           ***Ten digital radiographs of long leg standing (AP views) from normal and from patients~          with deformities will ne analyzed for length and angular differences using the LLD~          wizard.~           The following parameters will be measured *Hip joint radiographs: Acetabular Angle,~          Central Edge Angle, and Reimer's Index **Spinal radiographs: Cobe Angle (AP views),~          Coronal Balance, Sagital Balance. ***Long standing views: length of Femur and Tibia,~          mLDFA, mMPTA, mLDTA, JLCA, (the Baltimore numbers).~           All measurements will be taken by 4 senior orthopaedic surgeons after consensus~          conference for the technique.~           Intra observer reliability will be tested by repeating the same set of measurements on 2~          different dates, after all radiographs are randomly mixed and done at least 2 days~          apart. High resolution single computer will be used for all measurements by all~          participating surgeons.~           The intra and inter observer reliability for the hip joint measurements will be~          calculate to compared between TraumaCad software wizard and the DICOM measurements~          tools.~           All measurements using TraumaCad software will be analyzed for intra and inter observer~          reliability using accepted statistical tools.~           The study will be supervised by the department of statistics of TAU for maximum~          statistical significance.~      1) Sailer J, Scharitzer M, Peloschek P, Giurea A, Imhof H, Grampp S.~      Quantification of axial alignment of the lower extremity on conventional and digital total~     leg radiographs.~      Eur Radiol. 2005 Jan; 15(1):170-3. Epub 2004 Aug 5.~      2) Hankemeier S, Gosling T, Richter M, Hufner T, Hochhausen C, Krettek C.~      Computer-assisted analysis of lower limb geometry: higher intraobserver reliability compared~     to conventional method.~      Comput Aided Surg. 2006 Mar; 11(2):81-6~   "
212244|NCT00782210|"~     This primary objective of this study is to compare two doses of BI 1744 CL inhalation~     solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic~     obstructive pulmonary disease (COPD).~      The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also~     be compared to placebo.~   "
212245|NCT00782197|"~     The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the~     treatment of knee osteoarthritis.~   "
212246|NCT00782184|"~     Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40~     mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent~     reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared~     between the two treatment groups.~   "
212247|NCT00782171|"~     The purpose of this study is to evaluate the performance of a new dental implant with a~     modified surface in different loading protocols.~   "
212248|NCT00782158|"~     This study will determine the amount of liver scarring (fibrosis) or liver damage in people~     infected with 1) hepatitis B virus (HBV, a virus that can infect the liver); 2) HIV (the~     virus that causes AIDS); 3) both HBV and HIV; and 4) neither HBV nor HIV. Liver fibrosis and~     liver damage can have many causes, including alcohol, certain medicines, exposure to some~     contaminated foods and infections with viruses that affect the liver (such as HBV). About 25~     million people in sub-Saharan Africa are infected with HIV and about 50 million with chronic~     HBV, yet very little information is available on how many people are infected with both~     viruses and the medical implications of co-infection.~      Participants in Uganda s Rakai Health Sciences Program (RHSP) or Infectious Diseases~     Institute (IDI) clinic who are 18 years of age or older may be eligible for this study.~      People enrolled in the study come to the clinic for at least one visit and may be asked to~     return yearly. During the visit, participants undergo the following procedures:~        -  Questionnaire and a short interview about their health and quality of life.~        -  Physical examination and blood draw. The blood is tested for HBV and other factors that~          may suggest liver disease. Blood drawn at previous clinic visits or from other studies~          may also be tested.~        -  Liver evaluation using a FibroScan, a medical device that uses elastic waves to measure~          liver stiffness in a process similar to ultrasound scanning. For this test, the subjects~          lies flat on the back with the arm extended out. The tip of the machine s probe is~          covered with gel and placed on the skin between the ribs at the level of the right lobe~          of the liver. The machine produces a little tap on the skin that sends a wave out and~          checks how fast the wave moves. The speed of the wave indicates the amount of scarring~          in the liver.~   "
212249|NCT00782145|"~     RATIONALE: A Web site for stem cell transplant health information and support may be~     effective in helping parents improve their health-related knowledge, skills, and quality of~     life, which may also improve their children's quality of life.~      PURPOSE: This randomized phase III trial is studying a Web-based stem cell transplant support~     system to see how well it works compared with standard care in families of young patients~     undergoing a stem cell transplant.~   "
212250|NCT00782132|"~     Since the identification of the human immunodeficiency virus (HIV) and the acquired~     immunodeficiency syndrome (AIDS) in the 1980s, there have been significant advances made in~     the management and long-term prognosis for infected individuals. Currently, with the advent~     of highly active antiretroviral therapy (HAART), HIV-positive individuals may live a healthy~     and productive life for years to decades after diagnosis. As life expectancy has increased,~     this group of people has begun to engage in family planning. This has created a need for~     access to advanced reproductive technologies and fertility treatments. While attempting to~     achieve pregnancy, utilization of these services can help to minimize the risk of~     transmission in serodiscordant couples, and can allow treatment of subfertile couples. Access~     to these services may be limited in Ontario for a variety of reasons. The purpose of this~     study is to determine the access to infertility clinics and services in Ontario for couples~     in which one or both partners is infected with HIV.~   "
212251|NCT00782106|"~     The purpose of the study is to determine the feasibility of infusing a full 4-week dose of~     Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of~     recombinant human hyaluronidase needed to infuse that dose with no more than mild local~     adverse drug reactions.~   "
212252|NCT00782093|"~     The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic~     profile of volociximab intravitreous injection in subjects with subfoveal choroidal~     neovascularization secondary to age-related macular degeneration (AMD).~   "
212253|NCT00782080|"~     This study will determine the safety and efficacy of an herbal treatment in children and~     adolescents with ADHD.~      Study Design:~        -  Randomized~        -  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)~        -  Placebo Control~        -  Parallel Assignment~   "
212254|NCT00782067|"~     This study will investigate if the drug midostaurin taken orally twice daily is effective and~     safe in treating patients with aggressive systemic mastocytosis or mast cell leukemia with or~     without an additional hematological neoplasm.~   "
212255|NCT00782054|"~     Severe itching following burn injury is a common complication. As many as 87% of burn~     patients report severe itching. The intense itching can increase anxiety and can interfere~     with sleep and normal activities of daily living thus affecting quality of life. Often the~     itching will become so intense patients will scratch or rub the skin until an open wound~     develops. Current treatment for itching includes antihistamines, steroids. and/or~     moisturizers, but too often, the patient does not receive relief, even from drugs, and~     suffers undesirable side effects.~      Swiss-American Products, Inc, has developed a new skin moisturizer containing a blend of~     endopeptidase enzymes. These products have resolved itching in other types of skin disease~     such as dermatitis. The hypothesis that itching can be reduced through the use of these~     endopeptidase enzyme containing products in the post burn population will be tested.~   "
212256|NCT00782041|"~     Primary:~        -  To assess the overall response rate of oxaliplatin in patients with bidimensionally~          measurable disease at baseline.~      Secondary:~        -  To assess the safety and tolerability of oxaliplatin~        -  To assess time to progression and overall survival.~   "
212257|NCT00782028|"~     We hypothesize that relative to families who receive standard individual postpartum and~     pediatric care, families that receive group care will be more likely to have:~        -  Improved maternal and child health behaviors: i.e increased breastfeeding, exercise,~          child safety measures in the home and decreased smoking.~        -  Better health care use for babies: i.e. attend more care visits, on-time and complete~          immunizations and decreased emergency services use.~        -  Better psychosocial outcomes for the families: i.e. decreased stress and depression, and~          increased social support.~        -  Improved parenting skills: i.e. improved knowledge of child development, involvement in~          developmentally appropriate activities, and parental sense of competence.~   "
212258|NCT00782015|"~     This is a study of the effects of 3 oz almonds added daily to a National Cholesterol~     Education Program Therapeutic Lifestyle Changes (TLC) diet in improving endothelial function~     in patients with Coronary Artery Disease. The study seeks to determine if these effects are~     mediated via an increase in Nitric Oxide synthesis and reductions in dyslipidemia and~     systemic inflammation.~      Vascular reactivity will be assessed via flow mediated dilation with endothelium-independent~     and hyperemic flow measured in the right brachial artery by non-invasive 2-dimensional and~     Doppler ultrasound. Serum will be collected and analyzed for biomarkers of dyslipidemia,~     inflammation, endothelial function, vascular reactivity and oxidative stress.~   "
212259|NCT00782002|"~     The purpose of this study is to determine if IMC-18F1 is safe for patients, and also to~     determine the best dose of IMC-18F1 to give to patients.~   "
212456|NCT00779324|"~     The purpose of this study is to study the effect of amantadine on irritability and aggression~     caused by traumatic brain injury.~   "
212262|NCT00781963|"~     Sleep problems are common among older people, and research suggests that insomnia has~     negative effects on health and quality of life in older adults. Prior research suggests that~     insomnia symptoms are even more common among veterans compared to the general population. In~     addition, people with sleep problems also often have depression and other problems that seem~     to decrease their quality of life. In this study, we will test two methods of providing~     behavioral sleep interventions for treating insomnia in older veterans. The long-term~     objective of this work is to identify ways to improve access to these types of behavioral~     sleep interventions for older veterans, in order to improve their well-being and quality of~     life. This project will be conducted in outpatient clinics of the VA Greater Los Angeles~     Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia~     will be identified by a postal survey. Enrolled veterans with insomnia (N=150 total, 50 per~     group) will be randomized to one of three groups: Individual-Cognitive Behavioral Therapy for~     Insomnia (Individual-CBTI), Group-CBTI or a group-based Sleep Education Control Condition~     (Control). Measures of sleep, depression and quality of life will be performed at baseline~     (enrollment in the study), after the treatment is completed, and during assessments at~     6-months and 12-months follow-up. Main outcome measures will include sleep/wake patterns~     (sleep questionnaires and wrist actigraphy, which is an objective estimate of sleep and~     wakefulness), depression and self-reported quality of life. We hypothesize that the~     intervention will improve sleep and will improve depressive symptoms and quality of life at~     six months follow-up. We also expect that these improvements will be maintained at 12-months~     follow-up.~   "
212263|NCT00781950|"~     This Clinical Trial is being conducted to study how patients with peripheral arterial disease~     (a condition in which the blood vessels of the extremities are affected) respond to a dietary~     regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed~     have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of~     dietary flaxseed on exercise tolerance will be assessed.~   "
212264|NCT00781937|"~     This trial is conducted in North America. The aim of this clinical trial is to evaluate the~     potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as~     well as in overweight subjects who have medical problems such as hypertension (high blood~     pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).~      Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed~     by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).~   "
212265|NCT00781924|"~     The purpose of this study is to register the precision of image fusion between live~     sonography and CT, MRI or PET/CT of liver lesions and other focal lesions in the abdomen. To~     test whether it will be possible to biopsy guided by image fusion.~   "
212266|NCT00781911|"~     Determine the 6-month progression free survival (PFS) rate associated with cixutumumab in~     combination with depot octreotide acetate (octreotide) in participants with metastatic~     neuroendocrine tumors.~   "
212267|NCT00781898|"~     The aim of this project is to conduct a multi-site effectiveness study to determine whether~     the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will~     significantly improve outcome in parolees and probationers with a history of opioid addiction~     compared to TAU alone. Participants will be randomized to either treatment as usual in~     community programs or monthly injections of depot naltrexone for six months with treatment as~     usual in community programs. The effectiveness of depot naltrexone has never been studied in~     opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in~     treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are~     retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric~     functioning, and economic costs and benefit costs of naltrexone.~   "
212268|NCT00781885|"~     This study is an international, open-label, multi-center, Phase II, multiple dose,~     dose-finding study to investigate the safety, tolerability and pharmacokinetic~     characteristics of BPS-MR tablets in male and female patients with PAH.~      Patients who meet the inclusion/exclusion criteria will enter the Treatment Phase at a~     Baseline visit. Patients will begin taking one BPS-MR tablet (60µg) twice daily (b.i.d.)~     escalating by one tablet b.i.d. each week to a maximum dose of 600µg (ten tablets) b.i.d or~     until the patient reaches their MTD. Following the achievement of the MTD, patients will be~     down-titrated off BPS-MR in weekly one tablet b.i.d. decrements. Patients may, alternatively,~     elect to continue taking the study drug at their MTD in a separate open-label extension~     study.~   "
212269|NCT00781872|"~     Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which~     affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter~     problems. The disease is caused by an autoimmune mechanism, ie the immune system produces~     antibodies and cells which attack the self myelin antigens, causing therefore demyelination.~     The disease is clinically evident with relapses of neurological disability due to the~     dysfunction of the areas (plaques of multiple sclerosis) in which damage of myelin occurs.~     Disability can accumulate with time and the disease enters a progressive phase due to damage~     of the axons and irreversible neurodegeneration. Although, effective immunotherapies exist~     which downregulate the autoimmune anti-myelin reactivity and reduce the rate of relapses of~     MS (like Copaxone and interferons), there is no effective means today to stop the progression~     of disability and induce rebuilding of the destroyed myelin (re-myelination). Neuronal stem~     cells were shown to possess the ability to restore neuronal activity and produce new neurons~     through transdifferentiation. Various other types of stem cells were tested in animal models~     with promising results, revealing a potential for restoration of the neurological function in~     neuroimmune and neurodegenerative conditions and in central nervous system traumatic injury.~     Adult bone marrow derived stromal cells (MSC) were shown to induce similar (to the neuronal~     stem cells) immunomodulatory and neuroregenerative effects and were shown in our laboratory~     to induce neuroprotection in the animal model of chronic experimental autoimmune~     encephalomyelitis (EAE). These bone marrow derived MSCs offer practical advantages for~     clinical therapeutic applications, since they can be obtained from the adult bone marrow and~     therefore the patient can be the donor for himself, without any danger for rejection of the~     cells. In addition, MSCs carry a safer profile and are less prone to malignant~     transformation.~      Our initial clinical experience with 10 patients with ALS and 10 with multiple sclerosis show~     that intravenous and intrathecal administration of MSCs is feasible and safe.~      In this study we propose an explorative protocol with the injection of MSCs (both~     intrathecally and intravenously) in patients with MS, in an effort to prevent further~     neurodegeneration through neuroprotective mechanisms and induce neuroregeneration and~     restoration of neuronal function. This will be a phase I/II study.~      The primary endpoint will be to further evaluate the safety and feasibility of the treatment~     with MSC infusions, in MS patients. Additionally, the migration ability of the transplanted~     cells will be evaluated by tagging MSCs with the superparamagnetic iron oxide particle~     (Feridex) (an FDA approved cell tracking drug) for detection by MRI. MRI of the brain and~     spinal cord will be performed at weeks 1, 4, 12 and 24 to detect the migration of the stem~     cells. Clinically the patients will be followed by monthly evaluations of the MS functional~     rating scale (EDSS) scale. The MRI, will be also used to evaluate changes in the total volume~     of lesions in the brain and the degree of atrophy.~      Significance: Our center has performed the first clinical trial with intrathecal and~     intravenous injection of adult stem cells in MS and ALS patients and has gained experience~     during the last 3 years with this type of stem cells treatment. After having evaluated the~     safety and feasibility issues, we intent to proceed to the second stage, to evaluate the~     migration ability of those cells (their ability to reach the affected motor areas of the CNS~     gray matter, by tracking them with a paramagnetic material and visualize them by MRI), and~     evaluate indications of clinical efficacy. This project may provide information for possible~     therapeutic uses of this type of bone marrow adult stem cells in MS and ALS but may also~     serve as a pilot platform and pave the path for future applications of various types of stem~     cells in neurodegerative diseases in general.~   "
212270|NCT00781859|"~     The objective of this trial is to evaluate the safety and efficacy of intravitreal~     microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.~   "
212271|NCT00781846|"~     The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose~     of oral ridaforolimus administered in combination with intravenous bevacizumab in patients~     with advanced cancers.~   "
212272|NCT00781833|"~     The primary aims of this study are to determine the safety of the RFM System (Alfred Mann~     Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM~     system on lower limb strength and spasticity. The secondary aim is to analyze any improvement~     in the participant's mobility.~   "
212273|NCT00781820|"~     The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a~     placebo cream after non-surgical nail ablation with a 40% urea paste.~   "
212274|NCT00781807|"~     A prospective, multi-module intervention based on nutrition management, psychosocial support,~     and a controlled home-based physical exercise training program for patients on LVAD- support~     will be provided to improve outcomes in terms of survival and patients health-related quality~     of life (HRQoL) for the long-term. Physical capacity, neurocognitive, psychological factors,~     and adverse events will be assessed as potential independent indicators for HRQoL.~   "
212275|NCT00781794|"~     The purpose of this study is to evaluate the effect of single doses of NSA-789 on the P50~     component of the auditory evoked potentials and to assess the safety, tolerability and the~     concentration of NSA-789 in the blood, in nonsmoking patients with schizophrenia.~   "
212276|NCT00781781|"~     The purpose of this study is to analyze the results of incidence and severity of acute and~     chronic GVHD, (see addendum II) and of disease free survival with Alemtuzumab use~     (MabCampath®) in haematopoietic transplant of unrelated donor with reduced intensity~     conditioning.~   "
212277|NCT00781768|"~     The purpose of this study is to compare two different treatment protocols for treating nausea~     and vomiting in patients who have undergone bone marrow transplant. Patients will be assigned~     to one of two treatment groups.~      The first group will recieve ondansetron (Zofran) tablets combined with a medicine called~     dexamethasone given IV. Both of these drugs are commercially available.~      Patients in The second treatment consists of the first two drugs, plus a newly approved drug~     known as aprepitant (MK-869, Emend). This combination will be the treatment being tested. The~     combination is approved by the FDA for chemotherapy regimens known to cause a lot of nausea~     and vomiting. It significantly decreases the delayed (more than 24 hours after therapy)~     nausea and vomiting seen with these regimens.~   "
212278|NCT00781755|"~     This is a clinical research protocol to study the efficacy of combined varenicline (Chantix)~     and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been~     diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind,~     randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI~     plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1~     mg/day for a period of two weeks.~      The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge and~     withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy measures~     of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale, Questionnaire for~     Smoking Urge-brief, number of cigarettes smoked per day in the previous week, CO levels, and~     Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale scores on the last day~     of the study. Other primary outcome measures are to determine the effects of VAR-MI and~     PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions and reward~     responsiveness as assessed by a computerized task.~   "
212279|NCT00781742|"~     The purpose of this research study is to determine whether AZD6765 has an effect on the~     patient's depression when taken together with current depression medication. In addition,~     information will be gathered on how well AZD6765 is tolerated, investigate the levels of~     AZD6765 and the levels of the current depression medication in the blood. In addition, the~     research staff will determine if AZD6765 has any mood or calming effects (how you feel).~   "
212280|NCT00781729|"~     This study seeks to determine whether a specially designed Hatha Yoga program can reduce~     hyperkyphosis in men and women who are at least 60 years of age and who have excessive~     thoracic kyphosis.~   "
212281|NCT00781716|"~     This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients~     with acute ST elevation myocardial infarction. It also aims to analyze the current status of~     emergency PCI green channel (time taken from door→ hospital→ PIC sign-off→ needle→ balloon)~     for patients with ST elevation myocardial infarction in China.~   "
212282|NCT00781703|"~     The study will evaluate a unique natural experiment that aims to transform the primary care~     of patients with depression. The experiment's aim is to cause statewide implementation of an~     evidence-based care model for depression by changing the reimbursement system and by using an~     established regional collaborative (the Institute for Clinical Systems Improvement) to both~     facilitate the model's widespread use and certify that medical groups have implemented it.~     Study hypotheses include the following:~        1. Newly treated depressed patients in medical groups that have implemented the new~          reimbursement and facilitation will report receiving higher rates of best care processes~          than such patients in these medical groups before implementation.~        2. Rates of best care practices reported to be received by newly treated depressed patients~          two years after each medical group implements changes will be maintained at least at the~          rate reported by patients one year post implementation.~        3. Newly treated depressed patients in medical groups that have participated in the new~          reimbursement and facilitation will have greater improvement in depression symptoms and~          work productivity and lower healthcare costs than such patients in groups before~          participation.~        4. Medical group measures of priority for improving depression care, capability to manage~          change, and practice systems will be predictive of more patient-reported best care~          processes, both at one point in time and in change over time.~   "
212283|NCT00781690|"~     The current clinical study aims at defining an index of Anti Xa, which is the marker to~     evaluate the activity of heparin, at the end of the dialysis treatment and so showing the~     possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer.~     Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk~     of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.~   "
212284|NCT00781677|"~     The purpose of this neuroimaging study is to investigate the brain correlates of Major~     Depressive Disorder with anxiety symptoms as well as potentially identify predictors of~     treatment outcome.~   "
212285|NCT00781664|"~     The purpose of this study is to determine the cumulative irritation potential of the products~     listed by the Sponsor.~   "
212286|NCT00781638|"~     Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will~     receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to~     3 optional Adacolumn® apheresis treatments over 3 consecutive weeks. Primary end point is~     PUCAI at Week 12.~      The main part of the clinical investigation will be continued by a one year follow up for~     responders.~   "
212287|NCT00781625|"~     To investigate if administration of probiotics, either orally or vaginally,~        -  Can reduce the number of episodes of acute bacterial cystitis and/or~        -  Has tolerable adverse effect profile~        -  Improves general QoL in these women~        -  Improves the immune function and other physiological stress markers~        -  Reduces inflammation in urinary bladder epithelium~   "
212288|NCT00781612|"~     This is a global, multicenter, open-label safety extension study. Participants receiving~     single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with~     other agents in a Genentech/Roche-sponsored parent study who are active and deriving benefit~     at the closure of parent study are eligible for continued treatment in this study.~   "
212289|NCT00781599|"~     Little is known about the support needed to improve compliance with Chantix for smoking~     cessation. This is a two arm pilot study of African American smokers to provide varying~     levels of side effect management and compliance support during a 12 week treatment period.~     The primary aim of the study is to estimate the effect of induction support compared to~     standard care in increasing compliance with Chantix at month 3~   "
212290|NCT00781586|"~     The study is considered research because efficacy (how well a drug works) information is~     needed in healthy, 25-45 year-old, female subjects with moderate caffeine intake. The~     investigational product is available in the United States without a prescription~     (over-the-counter) as a nutritional supplement. The purpose of this study is to assess~     whether One-A-Day Weightsmart Advanced is safe and can increase metabolism and perceived~     energy in female subjects compared with caffeine or placebo (inactive drug). Participation in~     this study will last approximately 4 weeks and require about 4 outpatient visits to St.~     Luk's-Roosevelt Hospital Center. About 21 subjects are expected to participate in this study.~   "
212291|NCT00781573|"~     Although the optimal duration of clopidogrel (an anti-platelet agent) therapy has been~     established after bare metal stent implantation in the blood vessels of the heart, there is~     lack of consensus regarding the optimal duration of therapy after implantation of a drug~     eluting stents (DES). Current American College of Cardiology guidelines recommend clopidogrel~     use for at least one year in the absence of contraindications after DES implantation, while~     recognizing that the optimal duration remains unknown. While an extended clopidogrel therapy~     (that is beyond the current 1 year recommendation) may increase bleeding complication, it may~     reduce the rates of adverse cardiovascular events like heart attacks and repeat~     revascularization procedures. A clinical trial which randomizes patients with an uneventful~     one year course after a DES implantation, to an additional year of clopidogrel and aspirin~     therapy versus aspirin alone, will be able to answer the important question about the role of~     extended (2y) dual anti-platelet therapy with clopidogrel and aspirin after DES implants. The~     investigators hypothesize that clopidogrel discontinuation at 1 year post-DES implantation is~     associated with an increase in cardiovascular events during the one year of follow-up period.~   "
212292|NCT00781560|"~     This study is designed to survey the awareness rate of Chinese National Adult Lipid Treatment~     Guideline (2007) by cardiologists; To survey the control rate of the patients with~     dyslipidemia in real world; and to evaluate the percentage of hyperlipidemia patients who~     achieved target LDL-C level according to the Chinese National Adult Lipid Treatment Guideline~     (2007) following 8-week treatment by Crestor® 5mg or 10mg~   "
212293|NCT00781547|"~     The overall aim of this study is to investigate the effects of GH treatment in men with the~     Metabolic Syndrome and a high risk of developing type 2 DM.~      Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two~     parallel treatment groups with GH and placebo for 12 months.~      The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo~     administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU~     per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the~     target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will~     be reduced by half in the event of side-effects. Oral and written instructions in terms of~     administration and dosage will be given.~      The treatment can be discontinued by the patient. The treatment should be discontinued if~     malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease~     and in the event of any other side-effects that is considered as serious.~      The treatment code for each subject included in the trial will be kept at the Sahlgrenska~     University Hospital Pharmacy. This code can be broken on the request of the investigator.~      Compliance will be assessed by collecting empty vials from the study subjects. The treatment~     is discontinued at the end of the study.~   "
212294|NCT00781534|"~     a clinical study of Ginseng its potential affect on diabetes~   "
212295|NCT00781521|"~     This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day~     dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The~     currently approved regimen is twice daily for 10 days.~   "
212296|NCT00781508|"~     Sildenafil (Viagra) is known to reduce pulmonary hypertension. Heart failure patients also~     have pulmonary hypertension and several recent reports have shown that sildenafil leads to an~     improvement in their exercise capacity. In these studies sildenafil caused a reduction in the~     pulmonary and systemic vascular resistances, improved pulmonary gas diffusion and perhaps~     increased cardiac output. It is uncertain if left ventricular filling pressures are reduced~     and whether there is improvement in left ventricular relaxation. The investigators~     hypothesize that in heart failure patients the improvement in exercise capacity associated~     with sildenafil is related to a significant reduction in left ventricular filling pressures.~     The investigators propose to study 20 patients with stable but moderately symptomatic heart~     failure. The study design is a randomized cross-over trial of the administration of a single~     dose of sildenafil 50 mg or a matching placebo. Exercise capacity will be determined before~     and after the oral administration of sildenafil 50 mg or placebo. Left ventricular filling~     pressures will be assessed by Doppler echocardiography and the serum level of B-type~     natriuretic peptide (BNP is known to increase with higher left ventricular filling~     pressures). After an initial echocardiogram and performing a 6 minute walk test, the patient~     will then be given either sildenafil or a matching placebo in a randomized double-blind~     fashion. One hr later a blood sample for serum BNP, the echocardiogram and the 6 minute walk~     test will be repeated.~   "
212297|NCT00781495|"~     The purpose of this study is to find determinants of insulin-induced weight gain in type 2~     diabetes mellitus~      Primary objective: To find an association between weight gain after start of insulin therapy~     and physical activity levels.~   "
212298|NCT00781482|"~     This study will compare the interactions of a placebo and two FDA-approved sleeping~     medications, Eszopiclone (Lunesta) and Zolpidem (Ambien), with certain chemical receptors in~     the brain. We want to show that we can use positron emission tomography images to measure the~     binding of these medications to the receptors.~   "
212337|NCT00780936|"~     The purpose of this study is to determine the effect of a local anesthetic nerve block on~     markers of inflammation and pain after a sunburn. This is important because it may provide~     information regarding the way that nerve blocks help with the treatment of pain and in~     particular provide preemptive analgesia.~   "
212338|NCT00780923|"~     The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic~     inflammation in obstructive sleep apnea.~   "
212339|NCT00780910|"~     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b~     (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after~     previous treatment.~   "
212299|NCT00781469|"~     Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease affecting approximately~     1% of the adult population. The disease is characterised by inflammation of synovial tissue~     (ST) in multiple joints, which often leads to destruction of joint integrity, contributing to~     serious functional impairment and disability. The contributors to its pathology include joint~     inflammation, abnormal cellular and humoral responses, and synovial hyperplasia.~     Ultrasonography is a powerful, non−invasive, and feasible way to evaluate synovial~     hyperplasia and guide its collection by biopsy.~      Although RA is a systemic disease, it is not clear whether the gene expression profile~     exhibited by circulated peripheral blood cells and that expressed by the inflamed synovium~     mirror one another. Understanding this relationship would be useful not only in potentially~     having a relatively non−invasive means to predict response to therapy but it might be useful~     in better understanding differences in RA expression amongst patients with this disease, thus~     perhaps assisting in target identification through a better understanding of disease~     processes.~   "
212300|NCT00781456|"~     This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral~     contraceptive compared to placebo for decreasing the frequency and severity of~     menstrually-related migraine headaches.~   "
212301|NCT00781443|"~     This is a multicenter, randomized, double-blind, placebo-controlled study designed to~     demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway~     reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The~     study will randomize approximately 24 patients at five study centers. In the event of patient~     discontinuation from the study, additional patients may be enrolled at the discretion of the~     Sponsor.~   "
212302|NCT00781430|"~     The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the~     safety and tolerability of neratinib in healthy subjects and subjects with chronic liver~     disease.~   "
212303|NCT00781417|"~     This study will evaluate whether earlier intervention with vitamin D in stage II/III chronic~     kidney disease will prevent or delay secondary hyperparathyroidism. Subjects will receive~     vitamin D or placebo at study entry and will be followed for a period of one year. The~     hypothesis is that subjects given vitamin D will have lower PTH and higher 25(OH)D after 1~     year compared to placebo. Additionally, there will be less subjects who progress into~     secondary hyperparathyroidism in the vitamin D treated group compared to the placebo treated~     group.~   "
212304|NCT00781404|"~     OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO~     applied at the time of reperfusion to limit infarct size and LV remodelling in patients with~     ACSST submitted to primary ACTP.~      DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind~     study.~      PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction~     receiving primary PTCA within 6 hours after symptom onset.~   "
212305|NCT00781391|"~     This study is to demonstrate the safety and efficacy profile, in two different dose regimens~     of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of~     stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will~     be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, &~     Warfarin. The expected duration of the study is 24 months.~   "
212306|NCT00781378|"~     Recombinant tissue plasminogen activator (rt-PA) is currently the most commonly used~     thrombolytic drug in patients with pulmonary thromboembolism (PTE). Optimal dosing with~     maximal benefits and minimal risks is of great importance. Considering the lower body weight~     in general Chinese population, we compared the efficacy and safety of lower dose rt-PA~     50mg/2h regimen with the FDA-approved rt-PA 100mg/2h regimen in selected PTE patients.~   "
212307|NCT00781365|"~     In this project we develop and implement an intervention to improve hypertension control in a~     primary care setting that takes advantage of new technology (home blood pressure~     telemonitoring) and team models of care (pharmacist case management). The results of the~     project will have important implications for future efforts to improve care provided to many~     of the estimated 20 million Americans with uncontrolled hypertension.~   "
212308|NCT00781352|"~     This study was developed to test the hypothesis that the risk of colorectal cancer recurrence~     was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during~     colorectal surgery.~   "
212309|NCT00781339|"~     The purpose of this clinical trial is to study the effects of NVC-422 instilled into the~     bladder in reducing bacteria in the urine.~   "
212310|NCT00781326|"~     This study will examine whether combined use of an antidepressant medication and the~     medication nimodipine reduces risk of depression relapse in patients with vascular~     depression.~   "
212311|NCT00781313|"~     The primary aim of the survey is to ascertain the emergency preparedness among our families~     with diabetes mellitus and to obtain a percentage of unprepared to the ones who are prepared.~     The secondary aim is to demonstrate the relationship between disaster preparedness and~     factors like socio-economic status, parent's marital status, ethnicity and those who had~     prior experience of a disaster to those who have not experienced a disaster.~   "
212312|NCT00781300|"~     The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium~     surgery among patients using loteprednol and dexamethasone during the postoperative period.~   "
212313|NCT00781287|"~     This is an investigator-initiated, two-year, randomized, controlled, single-center,~     open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to~     3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study~     will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally)~     to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects~     with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+~     T-cells to a greater extent than a 3-drug HAART regimen.~   "
212314|NCT00781274|"~     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV~     in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.~   "
212364|NCT00780559|"~     The purpose of this study is to determine if an individually tailored diet and physical~     enhancement program can improve mobility, physical activity, and neuropathy in people with~     early diabetes.~   "
213596|NCT00764101|"~     Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training~     on attentional bias and on symptoms of Posttraumatic Stress Disorder.~   "
212315|NCT00781261|"~     Osteonecrosis of the hip is an important cause of musculoskeletal disability and finding~     therapeutic solutions has proven to be challenging. Osteonecrosis means death of bone which~     can occur from the loss of the blood supply or some other means. Although any age group may~     develop osteonecrosis, most patients are between 20 and 50 years old. The most common risk~     factor is a history of high steroid treatment for some medical condition. The next most~     common associated condition is a history of high alcohol use. There are some cases of~     osteonecrosis that occur in patients that are otherwise completely healthy with no detectable~     risk factors.~      In the earliest stage of the disease, x-rays appear normal and the diagnosis is made using~     MRI. The advanced stages of osteonecrosis begin when the dead bone starts to fail~     mechanically through a process of microfractures of the bone. As the disease progresses, the~     surface begins to collapse until, finally the integrity of the joint is destroyed. A wide~     range of surgical treatments with variable success rates have been proposed for the treatment~     of the osteonecrosis to preserve joint integrity, including core decompression, whereby the~     venous hypertension that ensues is lessened and revascularisation may be induced leading to~     bone repair. Nonsurgical treatment options are limited and usually result in a poor~     prognosis. Early stage disease can be treated with protected weight bearing and~     physiotherapy, however some studies have shown protected weight bearing to be associated with~     a greater than 85% rate of femoral head collapse. Unfortunately most studies indicate that~     the risk for disease progression is greater with nonsurgical treatment than with surgical~     intervention. There are no established pharmaceuticals for the prevention of treatment of~     osteonecrosis. Evidence is increasing that the nitrogen containing bisphosphonates may be~     beneficial in the treatment of osteonecrosis. One bisphosphonates (alendronate) has been~     evaluated in 60 patients diagnosed with osteonecrosis of the hip. Recent clinical studies~     have shown very promising results. All patients had symptomatic improvement after one year.~     Although the follow up time ranged from 3 months to 5 years, only 6 patients progressed to~     the point of needing surgery.~   "
212316|NCT00781248|"~     The purpose of the study i to demonstrate the safety and efficacy of a device that intends to~     reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between~     the tube and internal orifice (nose and pharynx)using micro vibrations~   "
212317|NCT00781209|"~     The aggregate of data pertaining to brain metastases suggests that optimal results are~     achievable with a 2-pronged approach that addresses both the specific focus (with surgery or~     radiosurgery) and the surrounding brain parenchymal tissue that may harbor micrometastases.~     Patterns of failure following treatment of metastases that arise in the posterior fossa have~     not been reliably defined. Although most would agree that radiosurgery alone is not~     sufficient treatment for focal metastases in the cerebellum, it may be possible to deliver~     less than WBI as an expanded port beyond the SRS volume.~      The current study acknowledges that at least two therapeutic modalities are requisite for~     patients with cerebellar metastases but hypothesizes that it is unnecessary to extend the~     treatment of ostensibly uninvolved brain tissue beyond the limits of the posterior fossa. In~     so doing, it is hoped that the putative advantage derived from foregoing whole brain~     irradiation (e.g., reduction in neurocognitive impairment) will not be at the expense of~     excessive surpratentorial failure.~   "
212318|NCT00781196|"~     Phenytoin, a common anti-seizure drug, leads to cosmetically unacceptable side effect of~     gingival overgrowth in a significant number of patients. There is some evidence of~     therapeutic effect of folic acid in cases of established phenytoin induced gingival~     overgrowth. In this study, the aim is to study the prospective preventive effect of low dose~     oral folic acid supplementation on phenytoin induced gingival overgrowth in epileptic~     children.~   "
212319|NCT00781183|"~     Exercise training has been shown to reduce breathlessness and improve the exercise tolerance~     of people with lung disease. However, the effect of exercise training on the walking speed~     selected by these people during day-to-day life is unknown. Furthermore,the investigator do~     not know if exercise training changes the maximum speed that these people can walk at for a~     long period of time. This study will examine the relationship between walking speed and~     walking endurance before and following exercise training in people with lung disease and~     contribute importantly to our understanding of how patients choose to walk in relation to~     their capabilities.~   "
212320|NCT00781170|"~     To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed~     by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and~     HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete~     remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used~     to upgrade remission.~   "
212321|NCT00781157|"~     This study is designed to determine the ED90 for a single dose of phenylephrine for the~     treatment of spinal induced hypotension in parturients presenting for an elective CD. The~     ED90 is the effective dose at which 90% of subjects will have a positive response to~     phenylephrine. The primary outcome measure is the ED90 for bolus phenylephrine. Secondary~     outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia,~     and the presence of hypertension following administration of phenylephrine.~   "
212322|NCT00781144|"~     In this study, we are experimentally investigating the assessment of forces used by skilled~     clinicians and beginning practitioners in palpatory techniques. The study will assess~     pressure used during palpatory diagnosis of the paraspinal region.~   "
212323|NCT00781131|"~     We hypothesize that pregabalin will decrease post-operative pain scores and opioid use~     following abdominal hysterectomy compared to placebo. This study has been designed to~     determine if after an abdominal hysterectomy, the addition of pregabalin to their~     peri-operative analgesia regimen will demonstrate superior analgesia compared to placebo in~     terms of lower pain scores and reduced usage of opioids. The primary outcome will be~     post-operative pain, measured by total opioid consumption.~      Do women undergoing an abdominal hysterectomy with general anesthesia and receiving~     pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the~     first 24 hours after their surgery than those women who received placebo?~   "
212324|NCT00781118|"~     A prospective, randomized multicenter study of subjects with a high-risk of having a~     myocardial infarction (MI) due to acute coronary syndrome or bypass surgery. There is no~     differential intervention administered to the two arms of the ALERTS Study. The study~     evaluates whether or not a patient alarm from the Guardian System will provide benefit (e.g.~     shorten pre-hospital delay) compared to symptoms-only ER presentation in the event of a heart~     attack. An amendment to the data analysis protocol was collaboratively created by AngelMed~     and FDA, and was adopted by AngelMed on 4/22/2017.~   "
212325|NCT00781105|"~     The Chinese PAC study (CLDT600ACN03) will evaluate the efficacy and safety of open label~     telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of~     the study is the proportion of patients achieving undetectable HBV DNA at week 52.~   "
212326|NCT00781092|"~     The primary objective of this study is to compare two post operative drop regimens for the~     management of dry eye and control of healing using FDA-approved ophthalmic solutions.~   "
212327|NCT00781079|"~     Serious mental illness (SMI) is the second most costly disorder treated in the VHA, yet~     clinical outcomes for these patients in public sector settings are often poor due to a~     combination of low quality care and severe cognitive and functional impairments evidenced by~     this group. While these problems are multifaceted, studies outside the VHA have shown that~     using consumer providers (CPs) can improve and augment public care. Similar to recovering~     addiction counselors, CPs are individuals with SMI who use their lived experiences to provide~     services to others with SMI. CPs can reach out to patients that are difficult to engage,~     assist patients with tasks of daily living, offer a variety of rehabilitation (vocational,~     social, residential) services, be role models and offer hope for recovery, and facilitate~     support groups. Randomized controlled and quasi-experimental trials, all done outside the~     VHA, have shown that CPs can provide services that yield at least equivalent patient outcomes~     with particular benefits noted on intensive case management teams. Based on these successes~     both the President's New Freedom Commission and the Veteran Administration's Mental Health~     Strategic Plan call for broader dissemination of CPs as way to make mental health services~     more recovery-oriented, a recent national priority. Because of these recent calls, employing~     mentally ill veterans has just begun, although no effort has been made to evaluate their~     impact inside the VA mental health system. Yet its success outside the VHA and the recent~     emphasis on recovery-oriented care suggests the need to test this model in the VHA.~   "
212328|NCT00781066|"~     Of the estimated number of 529,000 maternal deaths for the year 2000, 132,000 (25%) were~     caused by postpartum hemorrhage (PPH); 99% of these deaths occurred in low-income countries.~     Where maternal mortality is high and resources are limited, the introduction of low-cost,~     evidence-based practices for primary prevention of PPH is an urgent need. Controlled cord~     traction (CCT) is actively promoted in combination with prophylactic uterotonics for the~     prevention of PPH. While the administration of uterotonics has been proven effective, there~     is no evidence of CCT being beneficial or safe. The investigators propose this study to~     evaluate two primary questions:~        1. In women having term, single vaginal deliveries in hospital settings, in whom the third~          stage is managed with prophylactic oxytocin, does CCT produce a clinically significant~          reduction in the incidence of postpartum blood lose?~        2. In these women, does CCT produce a clinically significant increase in the incidence of~          severe complications, including uterine inversion or the need for subsequent surgical~          evacuation of retained placental tissues and membranes (curettage or manual removal)?~      To answer these two questions we designed two arms randomized controlled trial.~   "
212329|NCT00781053|"~     Transforming growth factor-beta 1 is consistently over expressed in most fibrotic diseases~     and displays a variety of profibrotic effects in fibroblasts(25, 26). Activation of TGF-beta~     receptors induces the activation of several kinase signalling cascades leading to the~     phosphorylation of SMAD proteins as well as to the activation of SMAD-independent kinases~     that collectively activate ECM synthesis and fibroblast growth and differentiation into~     myofibroblasts. TGF-beta 1 i one of the main mediators in the fibrotic process, associated to~     both scarring and a long list of pathologies related to chronic inflammation and which affect~     all type of organs and tissues. An increase in TGF-beta1 mRNA and protein levels has been~     described in these processes. Peptide 144 (P144)is a acetic salt of a 14mer peptide from~     human TGF-beta1 type III receptor (betaglycan). P144 TGF-beta1-inhibitor has been~     specifically designed to block the interaction between TGF-beta1 and TGF-beta1 type III~     receptor, thus blocking its biological effects. P144 has shown significant antifibrotic~     activity in mice receiving repeated sucutaneous injections of bleomycin, a widely accepted~     animal model of human scleroderma, and could contribute to the development. The aim of the~     study is to asses the long-term safety of topical application of P144 cream in the treatment~     of skin fibrosis in patients with systemic sclerosis in an extension open-label treatment~     period of 6 additional months.~   "
212330|NCT00781040|"~     The aim of this study is to find out whether inflammation markers including cardiac markers~     have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological~     patients.~   "
212331|NCT00781027|"~     The primary objective is to compare the effect of torsional phacoemulsification and~     longitudinal phacoemulsification on central and peripheral corneal thickness/volume after~     cataract surgery in patients with Fuchs' endothelial dystrophy.~   "
212332|NCT00781001|"~     The purpose of this study is to determine if vaporized cannabis is effective as an analgesic~     for the treatment of painful diabetic neuropathy.~   "
212333|NCT00780988|"~     Current therapies for metastatic colorectal cancer only prolong life for approximately 2~     years. A more innovative therapy that prolongs life significantly or even cures is needed.~     Bone marrow transplantation is a curative therapy for patients with leukemias and lymphomas.~     Tumor eradication in the case of transplantation of the patient's own marrow (autologous~     transplantation) is based on the intensive chemotherapy and/or radiotherapy used for~     conditioning. Tumor eradication in the case of transplantation using the marrow of a normal~     donor is based on both tumor reduction from conditioning and the immune elimination of tumor~     cells by T cells in the donor transplant that recognize the foreign tissue antigens expressed~     by the tumor cells and kill these cells. The use of bone marrow transplantation to treat~     tumors other than leukemia and lymphoma has been limited, and studies of transplantation of~     the patient's own marrow for the treatment of advanced /metastatic breast cancer have not~     conclusively shown benefit beyond conventional therapy.~      Recently, the Strober lab developed a preclinical model that effectively treated colon cancer~     in mice by combining immunotherapy and autologous bone marrow transplantation in order to~     markedly augment the anti-tumor potency of immunotherapy. They used the CT26 colon cancer as~     the therapeutic target either as a single subcutaneous tumor nodule, as a disseminated tumor~     in the lungs and peritoneum, or as a metastatic tumor in the liver depending on the route of~     administration of the tumor cells in BALB/c mice. Mice were vaccinated mice with established~     primary tumors or disseminated/ metastatic disease with irradiated tumor cells mixed with the~     adjuvant CpG, and found that vaccination alone had no effect on tumor growth. Similarly~     radiation conditioning of tumor bearing hosts followed by transplantation of bone marrow and~     spleen cells or purified T cells and hematopoietic stem cells from unvaccinated donors of the~     same strain had no effect. In contrast, radiation conditioning of mice followed by~     transplantation of hematopoietic and immune cells from donors of the same strain vaccinated~     with tumor cells and CpG cured almost all subcutaneous primary as well as disseminated and~     metastatic tumors in the hosts. A similar result was obtained after autologous~     transplantation of hematopoietic and immune cells from tumor bearing mice that had been~     vaccinated after tumor establishment. Investigation of tumor infiltrating cells showed that~     the injected donor T cells do not accumulate in the tumors unless the host has been~     irradiated before injection.~      Based on this model, we have assembled a team of Stanford University faculty members with~     expertise in gastrointestinal cancers, immunotherapy, radiation oncology, and bone marrow~     transplantation in the Departments of Medicine and Pathology to translate the preclinical~     findings into a Phase I safety and feasibility clinical study for the treatment of 10~     patients with metastatic colorectal cancer. Resected tumor cells will be irradiated and mixed~     with CpG to create a vaccine. Patients will receive subcutaneous vaccination at weeks 1 and 2~     after resection. Six weeks later, immune T cells and then G-CSF mobilized purified blood~     progenitor cells will be harvested from the blood and cryopreserved. If needed patients will~     receive chemotherapy for tumor reduction. When disease is controlled off chemotherapy,~     patients will receive a conditioning regimen of fludarabine (30mg/m2 daily x 3 days) followed~     by intensive fractionated total body irradiation. The dose of fTBI will be escalated using a~     3+3 design to ensure safety and will range from 400 to 800 gray. The patient will then~     undergo hematopoietic and immune cell rescue. They will undergo a third vaccination within~     7-14 days after transplant. Thereafter, serial monitoring of tumor burden will continue.~      Immune monitoring will occur before and after vaccination as well as after transplantation.~     Tests will include in vitro anti-tumor immune responses of T cells (proliferation,~     cytotoxicity, cytokine secretion etc.) to stimulation with whole tumor cells and tumor cell~     lysates pulsed on to antigen presenting cells, anti-tumor antibody responses, and immune~     reconstitution after transplantation.~   "
212334|NCT00780975|"~     This is a study to test the safety and efficacy of an investigational chemotherapy agent in~     patients with advanced prostate cancer. Subjects who meet all entry criteria and have signed~     the informed consent will be enrolled in the study. Participants will be required to attend~     regular clinic visits to receive study medication and have their status monitored. A detailed~     explanation can be provided by the investigator conducting the study.~   "
212335|NCT00780962|"~     Multiple agents have been studied to prevent radiocontrast nephropathy. One of these agents~     is N-Acetylcysteine. Previous trials to assess N-Acetylcysteine's efficacy in the prevention~     of contrast nephropathy have been promising. However, previous studies have limited~     applicability to the Emergency Department (ED) patient population for two reasons:~        -  1) Many of the pretreatment strategies employed in these studies take several hours or~          even days to perform, which is not feasible in acutely ill ED patients.~        -  2) Most of these studies were conducted in patients undergoing cardiac catheterization.~          This may be a very different population than patients in the ED undergoing abdominal or~          chest computed tomography.~      The investigators wish to study the efficacy of N-acetylcysteine as an agent to prevent~     radiocontrast nephropathy in ED patients undergoing computerized tomography. The~     investigators propose a randomized, double-blind, controlled trial comparing saline hydration~     plus N-acetylcysteine versus saline hydration alone. The hypothesis of this study is that~     N-acetylcysteine with normal saline will be more effective than saline alone in the~     prevention of radiocontrast nephropathy.~   "
212336|NCT00780949|"~     The project is based on adult and paediatric cohorts among the largest ones in Paris and~     located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM~     Unit U843 in collaboration with the department of immunology and statistics, Robert Debré~     Hospital.~   "
212340|NCT00780897|"~     Premature Ovarian Failure (POF), syndrome observed in young woman, present consequences on~     hormonal and leads at definitive infertility. It's a rare and complex syndrome and for this~     reason, we propose to initiate a collaborative team network to understand better his genetic~     and physiopathology.~      We are going to realize a global study of this syndrome with clinical and fundamentals~     approaches. We wish that this project allows us to understand better the physiopathology of~     this rare disease. Finally, POF responsible genes identification is the base for future~     development of therapeutics approaches.~   "
212341|NCT00780884|"~     Insomnia, a common feature of schizophrenia, has serious consequences for daytime functioning~     and quality of life. Although insomnia is most often treated with medication, a growing~     number of studies have demonstrated the efficiency of a variety of relaxation techniques,~     cognitive behavioral therapies and alternative medicine procedures. Acupuncture is among the~     oldest healing practices in the world. Part of traditional Chinese medicine, acupuncture aims~     to restore and maintain health through the stimulation of specific points on the body.~     Previous studies have demonstrated that acupuncture has a positive influence on a number of~     diseases and disorders, among them Depression, Chronic Pain and Sleep Disorders. Hence, the~     aim of the present study is to examine the effects of acupuncture as a treatment for insomnia~     in schizophrenic patients.The study begins with a 7-day, running-in, no-treatment period,~     followes by an 8-week experimental period. During the experimental period, subjects receive~     acupuncture treatments twice a week. During the first week of the study (no-treatment period)~     and the last week of the experimental period, subjects' sleep is monitored with a wrist~     actigraph, and subjects complete a wide spectrum of questionnaires.~   "
212342|NCT00780858|"~     Premature luteinization in patients undergoing IUI can occur in up to 24% of cycles. These~     patients, according to recent data, have a lower pregnancy rate than controls. The~     possibility to avoid premature luteinization with GnRH antagonist may restore the chances of~     achieving a pregnancy in these women.~   "
212343|NCT00780845|"~     The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump~     CABG.~   "
212344|NCT00780832|"~     The purpose of this study is to assess the effects of caffeine reduction/elimination on~     urinary symptoms in women with overactive bladders and compare this therapeutic approach to~     anticholinergic therapy. We hope to show a reduction in symptoms with caffeine reduction and~     determine how effective caffeine reduction is compared to medication. If caffeine reduction~     is shown to be beneficial, women may be encouraged to use this strategy before resorting to~     medications.~   "
212345|NCT00780819|"~     On regular (diagnostic) MRI images brain tumors can show contrast enhancement: uptake of an~     intravenously administered contrast agent can cause an enhancement pattern that is seen as a~     white area on a frequently used MRI protocol (T1 weighted imaging). High grade gliomas are~     a common brain tumor that share this enhancement pattern. The goal of surgery is to resect~     this contrast enhancing part without causing additional neurological damage. Intraoperative~     MRI (iMRI) is a helpful tool in achieving this goal, because it can provide updated images~     during resection and correct for deformations that occur in the brain during surgery. These~     deformations make preoperative images that are used for standard neuronavigation systems less~     reliable. However, due to manipulations during surgery, the contrast uptake during surgery~     may differ from contrast uptake in diagnostic MRI. This study aims to relate contrast~     enhancement on iMRI and tumor characteristics on tissue samples from the tumor. When the~     neurosurgeon considers the resection of the high grade glioma to be complete, an iMRI scan~     will be made, and tissue sampling will be performed on the borderzones of the tumor or tumor~     resection cavity respectively. This will provide insight in the relation between contrast~     enhancement on iMRI and the presence of tumor tissue. Such knowledge is important to improve~     effectiveness and safety of iMRI guided brain tumor resection.~   "
212346|NCT00780806|"~     The purpose of this study is to evaluate the safety of an investigational meningococcal B~     rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in~     assay development.~   "
212347|NCT00780793|"~     Remission is nowadays the recommended therapeutic objective in rheumatoid arthritis. Once~     this objective is achieved thanks to TNF-blockers, the optimal therapeutic strategy remains~     unclear, either therapeutic maintenance or progressive DMARD tapering (with a non quantified~     risk of disease flare).~      STRASS is a 2-arm randomized controlled trial aiming to compare these 2 strategies (DMARD~     maintenance or progressive spacing of TNF-blocker injections) in terms of remission~     maintenance, relapse risk, safety issues and economic consequences during 18 months.~      The inclusion period is 18 months, between September 2008 and February 2010.~   "
212348|NCT00780780|"~     Diabetics retinopathy remains the major threat to sight in the working age population in the~     developed world. Furthermore, it is increasing as a major cause of blindness in other parts~     of the world, especially developing countries. Diabetic macular edema (DME) is a~     manifestation of diabetic retinopathy that produces loss of central vision.~      The triamcinolone intravitreal injection (1-4mg) is indicated to treatment of diabetic~     macular edema and it is considered an important treatment since it improves the visual acuity~     of patients with resolution of edema.~      Nepafenac is a non-steroidal anti-inflammatory drug (NSAID), usually sold as a prescription~     eye drop (0.1% solution). Nepafenac is manufactured by Alcon as Nevanac. It is approved by~     FDA as well as ANVISA. Pre-clinical studies suggest this medication showed efficacy to treat~     ocular posterior segment inflammation.~      The purpose of this study is evaluate the efficacy of intravitreal triamcinolone associated~     with nepafenac eye drops as treatment of diabetic macular edema.~   "
212349|NCT00780767|"~     This pilot study is mainly aimed to evaluate the feasibility and safety of the percutaneous~     Angiojet Rheolytic Thrombectomy (ART) in patients presenting a MPE. Secondarily the~     effectiveness of this treatment modality will also be estimated.~   "
212350|NCT00780754|"~     Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups:~     dutasteride treatment group and watchful waiting strategy group. According to the study~     protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after~     randomization.~      There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided~     biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate~     cancer development for patients with high grade intraepithelial neoplasia (HPIN).~   "
212351|NCT00780741|"~     The purpose of this study is:~      To determine the cost-effectiveness of treating NLDO using immediate office probing compared~     with deferred probing in a facility setting. As part of the primary objective, the study will~     determine the proportion of eyes experiencing spontaneous resolution among subjects~     randomized to the deferred probing group.~      The secondary objectives are:~        1. To determine the success proportion for eyes undergoing immediate office probing as an~          initial procedure.~        2. To determine the success proportion for eyes undergoing deferred facility probing as an~          initial procedure.~   "
212352|NCT00780728|"~     This study will examine the effects of add-on sildenafil to bosentan monotherapy in patients~     with Pulmonary Arterial Hypertension. Patients on bosentan monotherapy will be followed every~     6 months to assess if they have met the pre-defined treatment goals. If a patient fails to~     achieve these treatment goals or fails to maintain them, sildenafil will be added to their~     existing bosentan monotherapy. Patients will be assessed 6 months after start of combination~     therapy for changes in 6MWT, Borg dyspnea scale, WHO functional class, quality of life.~   "
212353|NCT00780715|"~     This proposal is to fund a pilot study to assess feasibility and refine methodology for an~     intended large Scotland wide study on Response to Oral Agents in Diabetes (ROAD). The study~     will collect cohorts of patients who have carefully controlled standardised dose titration~     and monitoring with an assessment of drug response and side effects over a 6 month period.~     The primary aim will be to use these cohorts to investigate phenotypic and genotypic~     (pharmacogenetic) determinants of response.~      Drug naïve patients will be treated with Metformin. Patients who have failed on Metformin or~     are intolerant of Metformin will be randomised to gliclazide, pioglitazone or sitagliptin.~     With the ability to capture patient data beyond 6 months via data linkage we will monitor~     time to treatment failure and therefore compare which of the 3 oral agents is the best~     therapy to use after Metformin in a cost efficient and real world RCT.~   "
212354|NCT00780702|"~     Background:~        -  The effectiveness of methadone maintenance for treatment of heroin addiction has been~          well established. However, patients maintained on methadone may relapse to cocaine use,~          even when they are enrolled in a comprehensive treatment program. Relapse has been~          attributed to several factors, including drug-associated environmental stimuli.~        -  Aripiprazole is a drug used to treat schizophrenia and bipolar disorder, but it may have~          other uses. Research has shown that aripiprazole can reduce cocaine-seeking behavior in~          rats, and it has been investigated for use in treating amphetamine dependence. More~          research is needed to determine whether aripiprazole can prevent relapse to cocaine use~          in patients being treated with methadone.~      Objectives:~      - To determine whether aripiprazole prevents relapse to cocaine use more effectively than~     placebo in cocaine-abstinent patients maintained on methadone.~      Eligibility:~      - Individuals between 18 and 60 years of age who are current cocaine users seeking methadone~     treatment.~      Design:~        -  The study will last up to 41 weeks, with four phases of treatment and a follow-up~          evaluation. Three times a week, participants will be asked to report illicit drug use~          and provide urine and breath samples. Throughout the study, participants will receive~          individual counseling in weekly 40 60 minute sessions. Other samples and tests will be~          scheduled as required by the study researchers.~        -  Patients will be stabilized on daily methadone over the first 14 days of the study.~        -  Weeks 1 14: Participants will receive vouchers for regular cocaine-free urine samples.~          Those who successfully complete this phase will continue to the next part of the study.~        -  Weeks 13 27: Participants will receive either aripiprazole or placebo along with their~          methadone. During this part of the study, participants will keep electronic diaries to~          record cocaine use or craving and to record data on mood and activity.~        -  Weeks 28 33: Participants will stop taking the aripiprazole or placebo, but will~          continue the methadone treatment. Participants will continue to use the electronic~          diaries.~        -  Weeks 34 41: Participants will have the choice of transferring to a community clinic or~          gradually reducing doses of methadone to end the study.~        -  Participants will return for a follow-up visit and urine sample 6 months after the end~          of the study.~   "
212355|NCT00780676|"~     The goal of this clinical research study is to learn if researchers can use genetic tests to~     predict who may benefit from treatment with SprycelTM (dasatinib) or selumetinib (AZD6244).~   "
212356|NCT00780663|"~     This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in~     patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is~     to evaluate the rate of clinical benefit response to quarfloxin treatment including the~     reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable~     hormones or other biochemical tumor markers.~   "
212357|NCT00780650|"~     This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat Attention~     Deficit Hyperactivity Disorder(ADHD) has effects on the body's ability to defend itself~     against low blood sugar.~   "
212358|NCT00780637|"~     Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in~     culture. It has been proposed that the nerves of blood vessels are the source of bradykinin~     stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin~     into the brachial (arm) artery and the coronary arteries of heart transplant recipients and~     control subjects. This is because heart transplant recipients do not have nerves to their~     coronary arteries.~      This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant~     recipients. The brachial artery has intact nerves.~      Separate protocols address coronary artery infusions in healthy subjects and transplant~     recipients and forearm infusions in healthy subjects.~   "
212359|NCT00780624|"~     The submitted trial is the first prospective, randomized trial comparing nasal intermittent~     positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress~     syndrome.~   "
212360|NCT00780611|"~     This study will look at how tumors in the chest and abdomen move when you breathe. Your~     doctors are studying if extra 4D CT scans and instructions on how to breathe can help predict~     this type of movement and improve the accuracy of radiation treatment. 4D CT scans are~     approved by the FDA. A 4D CT scan is different from a regular CT because it moves slower and~     takes more pictures. It takes pictures of the way your body moves when you breathe. This~     gives doctors more pictures of your body so that they can match your pictures to the way you~     breathe.~      In this study, instructions on how to breathe will be visual and audio. Visual instructions~     will be given to you on a computer screen. You will hear audio instructions through a~     speaker.~   "
212361|NCT00780598|"~     The purpose of this study is to evaluate the efficacy and safety of tosedostat in elderly~     patients suffering from refractory or relapsed AML.~   "
212362|NCT00780585|"~     This is a safety study evaluating the subjects who participated in previous Organon trials of~     the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a~     possible Follow-Up period. During the visits, study tests, including echocardiograms, will be~     performed to summarize cardiac functioning.~   "
212363|NCT00780572|"~     The purpose of this study is to determine if an electronic alerting technology improves time~     to intervention for possible ADEs, identify what factors affect adoption of ADE alerts, and~     whether there is a cost benefit associated with the alerting technology.~   "
212365|NCT00780546|"~     Data will be extracted from the NTUH medical records database, geocoded according to the~     street address so that the case number, incidence, etc could be mapped. The spatial data~     would be used to detect aggregation of TB cases, existence of hot spots and then determine~     if they may merit further investigation or may have occurred by chance. The results from~     these GIS-based analyses would address local variations in TB incidence and transmission.~   "
212366|NCT00780533|"~     A total of 144 stroke patients 6 -24 months post onset who are between 45 and 75 years old~     will be recruited. A randomized-blocks pretest and posttest control group design will be~     applied. Four groups will be involved in this project and the subjects will be stratified on~     two variables: impairment level of the hand and side of lesion. Randomization will be done in~     blocks of six and each block randomization scheme is within each stratum. Treatment regimens~     will be designed to ensure that patients in 4 groups receive equivalent intensity of~     treatment (5 days/week for 1.5 hours/day for 4 consecutive weeks) directly supervised by~     senior occupational therapists.~      Brain and movement reorganization will be evaluated with fMRI and kinematic instrument,~     respectively before and after the 4-week intervention period. Clinical measures on motor~     impairment, daily function and quality of life will be assessed before, immediately and six~     months after intervention. Two examiners blind to group allocation will collaborate to~     provide both fMRI and kinematic evaluations and one of them will administer clinical~     measures. Before being allowed to work with subjects, the examiner competence will be~     assessed by principle investigator and co-principle investigators. Multivariate analyses of~     covariance will be used to examine change in brain activation, kinematic variables and~     clinical measures as a function of intervention while controlling for pretest data, age and~     onset post stroke. Multiple regression models will be established to examine the possible~     predictor(s) for functional outcome of each rehabilitation approach. Canonical correlation~     analyses will be conducted to quantify the relationship between brain/motor reorganization~     and clinical measures.~   "
212367|NCT00780520|"~     Glutamine levels decrease during severe sepsis; this may be associated with increased~     mortality. The investigators tested the effects of glutamine supplementation on systemic~     inflammation in a human sepsis model.~      The investigators found that glutamine levels drops significantly during experimentally~     induced systemic inflammation. However, glutamine did not affect the degree of inflammation.~   "
212368|NCT00780507|"~     The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare)~     while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and~     FL in UC patients who do not relapse (flare).~   "
212369|NCT00780494|"~     To investigate bevacizumab in combination with carboplatin and capecitabine for patients with~     unresectable or metastatic GEJ or gastric cancers. We hope that by adding bevacizumab to~     standard chemotherapy for this patient population we will improve Progression Free Survival~     by 80% over historical controls.~   "
212370|NCT00780481|"~     T-PA release is impaired in obese subjects. In order to have a better mechanistic~     understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation,~     Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.~   "
212371|NCT00780468|"~     This study will provide data on two systems for assigning point values to food choices in a~     diet plan. The primary purpose of this study is to compare the effectiveness of the two~     systems with regard to changes in body weight.~   "
212372|NCT00780455|"~     Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing~     Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical~     ability of patients with and without FRP.~   "
212373|NCT00780442|"~     In summary, this pilot study will explore the use of an innovative pharmacologic approach to~     the treatment of substance dependence through the facilitation of extinction of response to~     cocaine-conditioned cues in cocaine-dependent individuals. If DCS proves successful in this~     preliminary study, a controlled treatment trial will be planned. This novel approach could~     have implications for the treatment of multiple substance use disorders including~     methamphetamine, marijuana and opiate dependence.~   "
212374|NCT00780429|"~     Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in~     renal transplant patients already on long-term MMF treatment (at least 6 months~     post-transplant; at least 3 months in therapy).~      Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological~     activity and if there are any correlations with the risk of AR.~   "
212375|NCT00780416|"~     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b~     (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.~   "
212376|NCT00780403|"~     The primary objective of this study was to determine whether children ages 6-11 years prefer~     desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The~     secondary objectives of this study were to compare acceptance of the two attributes, taste~     and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets~   "
212377|NCT00780390|"~     To demonstrate that spinal cord stimulator has an effect on sympathetic function (the one~     that give us the fight and flight response). Therefore, if the spinal cord stimulator has an~     effect on sympathetic function, the responses from CRPS patients to different stimuli will~     differ significantly pre and post SCS implant.~      If CRPS patients exhibit autonomic, CRPS patients could be stratified according to their~     sympathetic function pre-implant. It is expected that patients with a moderate/mild form of~     autonomic dysfunction will have better outcomes with the SCS.~   "
212378|NCT00780377|"~     Heart transplant recipients do not have nerves to their hearts. This protocol tests the~     hypothesis that bradykinin mediated t-PA release in the coronary arteries will be reduced in~     heart transplant recipients compared to healthy subjects.~      This study will compare heart transplant recipients to healthy controls who are undergoing~     cardiac cath for standard of care purposes (separate protocol) and compare the coronary~     arteries to the forearm in transplant recipients (separate protocol) and healthy controls~     (separate protocol).~   "
212379|NCT00780364|"~     The objective is to establish the effect of sour taste and cold temperature on the pharyngeal~     swallowing transit time after ischemic hemisphere stroke.~   "
212392|NCT00780182|"~     The purpose of this study is to compare the bioavailability of CMX001 when administered as a~     tablet vs a solution and to determine the effect of a high-fat meal on CMX001~     bioavailability.~   "
212380|NCT00780351|"~     1. Sustained low efficiency daily hemodiafiltration(SLEDD-f) is a kind of renal replacement~          therapy with high-flux dialyser membrane (helixone).~        2. The pore size of helixone is larger than most antibiotics, and vancomycin is supposed to~          be removed during dialysis.~        3. Our study wants to find the amount of vancomycin removed during SLEDD-f, and try to find~          the most appropriate dose regimen for this kind of patients.~   "
212381|NCT00780338|"~     Alcohol and other drug use among youth is costly for communities. More research is needed~     about how to best support community based prevention programs and how community prevention~     expertise can inform the research process. The National Institute on Drug Abuse has funded a~     5 year collaboration of the RAND Corporation, Search Institute and its training division,~     Vision Training Associates, Communities for Children and Youth, and the University of~     Southern Maine to implement and assess the impact on prevention coalitions, the combination~     of two complimentary, community-based interventions: Developmental Assets, which supports~     community mobilization and collaboration to promote positive youth development, and Getting~     To Outcomes (GTO), which enhances community capacity to complete critical prevention tasks~     (e.g., evaluation). The purpose of the project is to investigate: 1) How well is the~     Assets-GTO intervention delivered, how much is it used, and what coalitions think about it;~     2) The extent to which the Assets-GTO approach enhances the prevention capacity (knowledge,~     attitudes, and skills) of individual coalition members and the quality of prevention~     performance; and 3) Whether enhanced prevention capacity improves alcohol and drug outcomes~     among youth. Twelve community-based prevention coalitions in Maine (part of Communities for~     Children and Youth) will participate. Six coalitions—determined at random—will receive~     manuals, training, and on-site technical assistance consisting of bi-Weekly meetings between~     A-GTO 4 ME! and key coalition staff. The other six coalitions will continue practice as~     usual, but will receive an abbreviated version of the Assets-GTO intervention near the end of~     the project. A Community Research Workgroup made of coalition representatives will review all~     aspects of the study and interim findings and facilitate dissemination on A-GTO 4 ME! The~     project will demonstrate and evaluate strategies to strengthen the prevention capacity of~     community organizations that can be used broadly across many types of programs.~   "
212382|NCT00780325|"~     Cyclooxygenase-2 (COX-2) inhibitors have become a common analgesic treatment option for~     patients with arthritis. However, long-term treatment has been associated with increased~     cardiovascular risk. With the past withdrawals and rejections of approval for COX-2~     inhibitors the treatment options are now very limited.~      This translates for example to about 10 million osteoarthritis patients in the US who cannot~     receive COX-2 inhibitors because of concomitant hypertension. And this exemplifies the unmet~     medical need to develop and offer safe treatment options for this particular patient~     population.~      This trial investigates pharmacodynamic aspects of CG100649 which is being developed as a~     novel COX-2 inhibitor. Preclinical data show a dual mechanism of action, which consists of~     the inhibition of the two enzymes COX-2 and carbonic anhydrase-I/-II (CA-I/II) and through~     which the cardiovascular risk of COX-2 inhibition might be attenuated.~   "
212383|NCT00780312|"~     The purpose of this study is to investigate whether the extent of late sequelae~     symptoms(reduced mouth opening, lymphoedema, decreased range of motion in the neck and~     shoulder region, speech and swallow disorders and reduced facial expression) due to~     radiotherapy treatment for head and neck cancer can be reduced by an individually adjusted~     physiotherapy effort applied immediately after the onset of and during radiotherapy~     treatment.~   "
212384|NCT00780299|"~     Rationale: Despite spontaneous cardiac activity recovery, a shock occurs in more than half of~     patients after resuscitation for cardiac arrest. This acute circulatory insufficiency~     presents similar characteristics with septic shock and is responsible of most early deaths.~     Most frequently, usual treatments are unable to control this shock and to avoid the~     appearance of multiple organ failure.~      Aim of the study: In addition to conventional therapeutics, an early plasma epuration of~     inflammatory mediators (HDHP) could be able to improve hemodynamic parameters and to reduce~     the shock duration. This improvement could have an impact on multiple organ dysfunctions and~     also on early mortality.~   "
212385|NCT00780273|"~     Change in crestal bone level implants at 5% significance level.~   "
212386|NCT00780260|"~     The purpose of this study is to test two innovative case management approaches designed to~     increase linkages and engagement with drug abuse treatment, HIV-related care, and other~     health services among an underserved population of African American women at risk for HIV.~   "
212387|NCT00780247|"~     Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is~     solar exposure, with cutaneous synthesis of vitamin D by photoconversion of~     7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin~     pigmentation, and age are recognized factors that influence how much vitamin D can be made by~     solar exposure. However, the relative influences of each are largely unknown and we cannot~     reliably answer the question of how much sun exposure an individual needs at various~     latitudes and at various seasons in order to ensure normal vitamin D status.~   "
212388|NCT00780234|"~     This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic~     subjects at risk for lung cancer (based on smoking history, lung function testing, and~     atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest~     computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at~     the start of the trial and after 6 months on treatment. Compensation will be provided to the~     subject after completing the trial.~   "
212389|NCT00780221|"~     The recognition of the association between circulating C-reactive protein (CRP) levels and~     risk of coronary heart disease (CHD) has led to an increased emphasis on CRP genetic effects~     on CRP level and CHD. However, the causality of CRP variants remains uncertain.The objective~     of this study is to evaluate the association of CRP gene variants and CRP levels in CHD in~     Chinese Han population. We conduct case-control study in CRP-Han study participants. The~     common single-nucleotide polymorphisms (SNPs) in the CRP gene, haplotypes, and plasma CRP~     levels are detected. A Mendelian randomization analysis will be used to help test the~     likelihood of causal association of gene-CRP levels, CRP levels-CHD and gene-CHD. The~     investigators hypothesize that CRP gene variants influence the protein level and may~     participate in CHD progress.~   "
212390|NCT00780208|"~     The purpose of this study is to evaluate the effectiveness and safety of Daytrana® in the~     treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused~     stimulants in the past. Daytrana® is a stimulant medication that has been approved by the~     Food and Drug Administration for the treatment of ADHD in children over the age of 6 years~     old.~   "
212391|NCT00780195|"~     We do not know why diabetic patients cannot protect themselves against low blood sugar.~     Therefore, in this study, we will perform a comprehensive assessment of the body's response~     to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve~     signals.~   "
228313|NCT00568659|"~     The investigators aim is to study the specific lung elastance in ALI/ARDS patients during~     invasive mechanical ventilation, in supine and prone position.~   "
212394|NCT00780156|"~     Background~      Drug-eluting stents (DES) have been extremely successful in reducing restenosis and the need~     for repeat revascularization procedures in patients who undergo PCI. The potential increased~     incidence of late stent thrombosis prompted cardiologists to prolong the use of dual~     anti-platelet therapy after the one year duration recommended by the recent ESC guidelines.~     However, while the premise that the cardiologists should put all their patients on dual~     clopidogrel-aspirin regimen for life sounds the easy way, it is an unrealistic goal because~     of the potential increase of bleeding complications and of the healthcare cost increase. The~     recent possibility to monitor aspirin with bedside assays offers a real opportunity to~     compare in good aspirin responder patients the two strategies: aspirin-clopidogrel regimen~     versus mono-aspirin regimen and to respond to the key question: can the investigators switch~     from dual to single antiplatelet therapy after six months in good aspirin responder patients~     ? Study National, multicenter, randomised prospective open group comparison of dual~     clopidogrel-ASA versus single ASA regimen after six months, in good ASA responder patients~     treated with DES (name: XIENCE) implantation.~      End point Primary: At 12 months: death, myocardial infarction, repeat urgent~     revascularization, stroke requiring a new hospitalisation and major bleedings.~      Secondary: Incidence at 24 and 36 months after drug eluting stent(name: XIENCE) implantation,~     of the same composite endpoint and incidence at 12, 24 and 36 months of minor bleeding~     complications Participating centres: 60 french centers~      Date of study beginning: November 2008 Duration of inclusion: 9 months Duration of study: 45~     months~   "
212395|NCT00780143|"~     This is a Phase I/II study to determine the safety, tolerability and to identify the MTD and~     DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with~     relapsed/refractory leukemia and to determine the response rate of the combination of~     Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.~   "
212396|NCT00780130|"~     The purpose of this investigation is to determine the relationship of core stability to core~     proprioception~   "
212397|NCT00780117|"~     Contribute to support hypothesis of relationships between genes involve in oncogenesis and~     those involve in embryological development.~   "
212398|NCT00780104|"~     The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in~     combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk~     myeloid leukemias.~   "
212399|NCT00780091|"~     OPTIMON will compare the efficacy and the cost of two monitoring strategies: one based on the~     classic standards of quality assurance, and the other one being a priori optimized on the~     main scientific and regulatory principles.~   "
212400|NCT00780078|"~     Patients with failed extubation stay significantly longer in an intensive care unit (ICU) and~     have a higher mortality rate, than those intubated successfully. Reintubation is associated~     with life-threatening complications and a poor prognosis. Functional respiratory tests are~     frequently used as weaning parameters, however, they are not accurate enough to predict~     extubation failure. The incidence of swallowing dysfunction is underestimated, mainly among~     patients whose intubation lasts longer than 48 h.We previously observed that the assessment~     of the swallowing function and oropharyngeal motricity, conducted by the physiotherapist~     before extubation could be helpful for making decisions to extubate patients intubated for~     over 6 days. The objective of this study is to validate a scale previously devised and used~     for physiotherapist bedside evaluation of the swallowing function and oropharyngeal~     motricity, among patients intubated for over 6 days, to determine whether this scale is a~     good predictor of airway secretion-related extubation failure.Expected results : to validate~     a scale previously devised called  physiotherapist evaluation of the swallowing function and~     oropharyngeal motricity before extubation by the mean of a multicentric study. In our~     hypothesis the clinical parameters studied could be predictive of extubation failure. Then,~     this evaluation could help the medical decision in the choice of the good time for~     extubation. The final objective is to lower the mortality related to extubation failure.~   "
212401|NCT00780052|"~     The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides~     (ODNs)is a possible treatment modality for advanced hematologic malignancies.~   "
212402|NCT00780039|"~     Doxorubicin has been used to treat ovarian cancer as part of different combination therapies,~     but high cumulative doses should be avoided because of the risk of cardiotoxicity. Pegylated~     Liposomal Doxorubicin (Caelyx) has been developed to reduce the risk of cardiotoxicity. The~     purpose of this study is to evaluate the safety and efficacy of Caelyx in combination with~     carboplatin in women with recurrent ovarian cancer.~   "
212403|NCT00780026|"~     The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict~     glycemic control to improve survival and infection rates following liver transplantation in a~     randomized, prospective trial.Primary objective: To determine if strict intraoperative blood~     glucose control, when compared to standard intraoperative glycemic control, improves 1-year~     recipient survival and decreases surgical complications, including infections, following~     liver transplantation.~   "
212404|NCT00780013|"~     The objective of this study was to compare the single-dose oral bioavailability of metformin~     hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy with GlucophageA® 1000 mg tablets of~     Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and~     female volunteers under fed conditions~   "
212405|NCT00780000|"~     The purpose of this study is to determine the anti-tumor activity (via objective response~     rate) of alvespimycin in patients with breast cancer who have not previously received~     trastuzumab (except as adjuvant therapy).~   "
212406|NCT00779987|"~     The purpose of this study is to compare the reduction in symptomatology of patients with~     severe dry eye treated with autologous serum and conventional artificial tears.~   "
212407|NCT00779974|"~     The primary objective is to document function of the structurally intact subscapularis after~     total shoulder arthroplasty by using electromyography. Structural integrity of the~     subscapularis will be confirmed using ultrasound.~      The secondary objective is to determine the diagnostic accuracy of the belly compression and~     lift off tests in evaluating the integrity and function of the subscapularis when compared to~     the ultrasound and electromyography (EMG).~      This will be accomplished by enrolling and evaluating patients with a primary diagnosis of~     osteoarthritis who have had a total shoulder replacement preformed by the PI from September~     2003 through December 2007.~   "
212408|NCT00779961|"~     The effect of timing of cleft palate repair on speech development, velopharyngeal~     functioning, and facial growth remains unknown. The objective of this study is to determine~     the effectiveness of early palatal repair versus The Hospital for Sick Children (SickKids)~     routine palatal repair in isolated cleft palate patients by comparing speech development,~     velopharyngeal functioning and facial growth outcomes. The null hypothesis is no difference~     in speech development, velopharyngeal functioning and facial growth between early palatal~     repair and SickKids routine palatal repair in isolated cleft palate patients.~   "
212409|NCT00779948|"~     Evaluation of dynamic Plate-Screw-Systems for internal fixation after femoral neck fractures.~     Open Registry for Comparison of 1-screw-systems (DHS) with multi-screw-system Targon FN.~   "
212410|NCT00779935|"~     This is a Phase 4, multi-center, open-label, one-arm, pilot study in patients with active~     ankylosing spondylitis refractory to conventional treatment. Remicade will be given at Weeks~     0, 2, and 6 and then every 8 weeks up to Week 54. The number of patients showing ASAS-20~     clinical response at Week 14 will be evaluated.~   "
212411|NCT00779922|"~     The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in~     patients presenting with Multiple Myeloma and impaired renal function, the safety of~     Revlimid® in the enrolled patients population.~      and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM~     and impaired renal function at completion of 3 cycles of treatment.~   "
212412|NCT00779909|"~     The burden of chronic gingivitis and periodontitis in the US is disproportionately high among~     Non-Hispanic Blacks compared to Non-Hispanic Whites. Chronic gingivitis is a highly prevalent~     chronic inflammatory disease that may progress into periodontitis, a major cause of tooth~     loss, Data from in-vitro and animal studies suggest anti-inflammatory effects of vitamin D;~     however, if and over what dose-range vitamin D may have anti-inflammatory effects in humans~     is uncertain. Recent clinical studies indicate that beneficial effects of vitamin D for~     several important outcomes may occur over a wide range of serum 25-hydroxyvitamin D (25-OHD)~     concentrations, possibly up to concentrations that would require vitamin D intakes ranging~     from 2 to more than 10 ten times higher than the current RDA for vitamin D. Because dark skin~     pigmentation is a potent inhibitor of vitamin D photosynthesis, Non-Hispanic Blacks have much~     lower 25-OHD serum levels than Non-Hispanic Whites. These differences in vitamin D status may~     partially explain the racial disparities in prevalence of chronic gingivitis and~     periodontitis observed in the US.~      We hypothesize that oral cholecalciferol supplementation can reduce susceptibility to~     gingivitis over a wide range of serum 25-OHD concentrations in Non-Hispanic Whites and~     Non-Hispanic Blacks. We propose to conduct a simple, single-center, randomized, double-blind,~     placebo-controlled parallel-group dose-ranging study. We will compare placebo to doses of 500~     IU, 2,500 IU and 5,000 IU vitamin D3 per day. We will compare the severity of gingival~     inflammation that develops in response to a 28-day period of unlimited plaque growth~     (experimental gingivitis) between dosage groups. Furthermore, we will evaluate the~     association between achieved 25-OHD levels and gingival inflammation.~      The results of this study will have several important implications, as dietary vitamin D~     supplementation may be a simple, safe and inexpensive means by which to reduce racial/ethnic~     disparities in gingivitis, as well as to reduce the overall burden of oral disease in the~     population as a whole. The study will elucidate the dose-response relationship of the~     anti-inflammatory effects of vitamin D, which in turn may lead to a revision of the current~     recommendations regarding nutritional supplementation of vitamin D in order to optimize the~     prevention of important medical conditions and diseases and reduce racial health disparities.~   "
212413|NCT00779896|"~     This is an open label, prospective study to evaluate therapeutic potential of Tazarotene 0.1%~     cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled~     into the study. Tazarotene will be used for up to 24 weeks and patients will be followed for~     up to 12 months.~   "
212414|NCT00779883|"~     The study is a Phase I, dose-escalating, non-randomized, single institution clinical trial~     assessing the safety and efficacy of autologous Ad-ISF35-transduced CLL B cells administered~     as a single intravenous infusion in patients with chronic lymphocytic leukemia (CLL).~   "
212415|NCT00779870|"~     Our hypothesis is that the severity of asthma is determined by the way in which airway smooth~     muscle cells grow and release inflammatory mediators. Our main objective is to establish how~     the properties of the airway smooth muscle cell varies with asthma severity. Environmental~     agents, such as cigarette smoke, and inflammation can give rise to oxidative stress - this is~     a process whereby harmful chemicals called free radicals are formed in the body and damage~     tissues. The damage caused can be limited/prevented by protective, or anti-oxidant mediators.~     We will also look at molecules involved in oxidative stress which may affect the way in which~     the airway smooth muscle grows and produces inflammatory mediators.~   "
212416|NCT00779857|"~     Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion~     Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.~   "
212417|NCT00779844|"~     Pharmacokinetic models for anesthetic agents are questionable. The objective of the study is~     to compare the propofol and remifentanil doses required to maintain the bispectral index in~     the range 40-60 in two groups of patients: obese patients and lean patients~   "
212418|NCT00779831|"~     Compare bioavailability of Pseudoephedrine hydrochloride extended release tablets (Ranbaxy~     Laboratories Limited) against reference product Sudafed ® 12-hour tablets 120 mg~     (Warner-Lambert) under fasting conditions.~   "
212419|NCT00779818|"~     This is a treatment for low back pain using electrical stimulation and laser for 6 weeks.~   "
212420|NCT00779805|"~     The objective of the study was to compare the single dose oral bioavailability of~     Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of~     Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.~   "
212421|NCT00779792|"~     The purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone~     acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a~     cumulative skin irritation test model using healthy volunteers.~   "
212422|NCT00779779|"~     This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use~     of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than~     24 weeks (second dose).~   "
212423|NCT00779766|"~     This is a multicenter study in which women are planned to receive either the HPV vaccine or~     control. Study participation will last approximately 72 months and involves a total of~     thirteen or fourteen scheduled visits.~      Originally, the study was planned for 24 months. It was then extended for 2 more years with 4~     additional visits (study end at Month 48).~      The protocol posting has been updated as the study will be extended by additional 2 years~     with two or three additional visits (study end at Month 72) for subjects who consent to~     participate in the extension.~   "
212424|NCT00779753|"~     The purpose of this study is to establish the parenteral lysine requirements for neonates.~   "
212425|NCT00779740|"~     This is a multicenter, open-label, randomized, parallel group comparison study to verify the~     clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of~     solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in~     patients with perennial allergic rhinitis.~   "
212426|NCT00779727|"~     Randomized controlled trial assessing the benefit of cesarean wound drainage in pregnant~     women at increased risk of hemorrhage. The pregnant women at increased risk of hemorrhage~     were randomised in two groups. In one group 2 wound drainages were placed during the cesarean~     section, in the other group none. Outcome measures were difference between preoperative and~     postoperative hemoglobin, postoperative fever, cumulative opiate dose adjusted to body~     weight, length of stay and operation time. It is postulated that the pregnant women with~     increased risk of hemorrhage do not profit from the routine placement of wound drainages.~        -  Trial with surgical intervention~   "
212427|NCT00779714|"~     This phase III trial is aimed to investigate the efficacy of an individualized,~     sensitivity-directed combination chemotherapy in comparison to the standard regimen DTIC.~      Two question are aimed to be answered by this study:~        1. Is the individual chemosensitivity index (BICSI) a prognostic / predictive biomarker for~          chemotherapy ?~        2. Is an individualized, sensitivity-directed combination chemotherapy superior to the~          standard regimen DTIC in terms of survival and response ?~   "
212428|NCT00779701|"~     Glycemic control can be safely achieved in surgical and medical intensive care unit settings~     and has been shown to improve short and long-term clinical outcomes. As such, insulin~     infusion protocols are routinely used in the ICU setting. The investigators plan to establish~     the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED~     setting. The investigators propose to study the aspects of implementing a strict glycemic~     control protocol in the ED.~   "
212429|NCT00779688|"~     This registry will collect data from patients routinely undergoing an ERCP and Cellvizio~     endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due~     to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy~     images collected using the marketed Cellvizio device may help endoscopists more accurately~     diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected~     lesion is malignant or benign.~   "
212430|NCT00779675|"~     This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study~     of infliximab in participants with plaque-type psoriasis to assess the clinical response in~     real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a~     psoriasis population, prescribed in a regimen in accordance with the product monograph (PM)~     for Canada, the approved summary sheet of product characteristics (SPC) for countries in the~     European Union (EU), or per label according to local guidelines for all other participating~     countries.~   "
212431|NCT00779662|"~     This study is an epidemiological observational cross-sectional study designed to estimate the~     prevalence of echocardiographically confirmed RHD in school children from 5-14 years of age~     in Fiji. The study will be conducted in the Central Division of Fiji within a selection of up~     to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions. School~     children will be enrolled after informed consent has been obtained. A standard cardiac~     examination (auscultation) will be performed as part of the routine annual health check by~     both school nurses, who have attended a training workshop, and by a paediatrician. All~     children with or without murmur will have a screening echocardiogram performed at a~     subsequent visit. Children found to have possible, probable or definite RHD or other cardiac~     pathology on the screening echocardiogram, will have a full echocardiogram performed by the~     echocardiography technician at the time of the second study visit. They will all also be~     referred to a paediatric cardiologist for further investigation and management and monitoring~     . Cases of RHD will be referred to and followed up by the National Fiji RHD register based at~     CWMH in Suva.~   "
212432|NCT00779649|"~     A properly prepared colon is vital to the success of any colonoscopy. The purpose of this~     study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping~     agent.~   "
212433|NCT00779636|"~     This was a placebo controlled study designed to evaluate the effectiveness of desloratadine~     in relieving symptoms of allergic airway disease during the pollen season. Patients received~     desloratadine 10 mg or placebo once daily for 28 days, and had their allergy symptoms and~     side effects to medication measured on Day 1, Day 15, and Day 29 (one day after stopping~     study drug).~   "
212434|NCT00779610|"~     This pilot study is designed to analyze the effects of Vibration Therapy (VT) on grip~     strength and level of forearm contraction by measuring hand grip dynamometry and surface~     Electromyography (sEMG) using the BioPac sEMG and digital dynamometry devices after the~     application of both passive and active Vibrational Therapy (VT) using the PowerPlate.~   "
212435|NCT00779597|"~     This study will test the SCION (Self care improvement through oncology nursing)-PAIN program,~     a multi-modular structured intervention to improve self management in oncologic patients with~     pain compared to care as usual (standard pain treatment and standard care). The study will~     determine if the self management skills of the patients continue to be used when the~     intervention stops, e.g. after discharge from hospital.~      It is hypothesized that patients who receive the multi-modular structured intervention will~     have less patient-related barriers to the management of cancer pain.~   "
212436|NCT00779584|"~     This study of MK-8776 (SCH 900776) will evaluate its safety and tolerability when given as~     monotherapy or in combination with gemcitabine to participants with advanced solid tumors or~     lymphoma. Participants will be enrolled in cohorts that will receive sequentially higher~     doses of MK-8776 in combination with standard doses of gemcitabine The recommended~     combination doses for a Phase 2 trial (combination-RP2D) will be determined based on safety~     and biological activity. Up to 10 to 15 additional participants may be studied at the~     combination-RP2D.~   "
212437|NCT00779571|"~     This study has two phases:~        1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on~          manifestations of PCOS, including risk factors for the metabolic syndrome and~          cardiovascular risk profile will be compared.~        2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above~          mentioned parameters will be compared and evaluated.~   "
212438|NCT00779558|"~     Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac~     patients. It remains unclear if a heparin infusion, compared to a normal saline infusion,~     prevents thrombosis of CVCs after surgery. This study will answer the question: does a~     low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline~     infusion, in patients less than one year of age after cardiac surgery?~   "
212440|NCT00779532|"~     The trial is a single-center randomized, double-blind, double-dummy, placebo and positive~     controlled, parallel group clinical trial.~      This trial investigated whether NOMAC-E2 (Org 10486 -0 + Org 2317), a new combined hormonal~     contraceptive, has potential to delay cardiac repolarization. The primary measure of cardiac~     repolarization in this trial is the Fridericia corrected QT interval (QTcF). QTcF represents~     the duration of ventricular depolarization and subsequent repolarization. A delay in cardiac~     repolarization creates an electrophysiological environment that favors the development of~     cardiac arrhythmias, most clearly torsade de pointes (TdP), but possibly other ventricular~     tachyarrhythmias.~      The primary aim of this study is to investigate, if the administration of a therapeutic~     (2.5/1.5 mg) or supra-therapeutic (higher than required for treatment: 12.5/7.5 mg) dose of~     NOMAC-E2 administered over a period of 14 days will prolong the mean QTcF interval to values~     above the accepted threshold of regulatory concern.~      In addition, a single dose of moxifloxacin will be administered in order to prove that~     sensitivity of the applied assay is sufficient to detect the prolongation of the~     QTcF-interval.~      Secondary aims of this study are to evaluate the relation between concentrations of NOMAC~     (therapeutic and supra-therapeutic) after steady state has been reached in the subject's~     body, the time matched change in Estradiol E1 and E2 in relation to baseline and the QTcF~     intervals after multiple dose administration of NOMAC-E2.~      Finally, the safety and tolerability of different treatments are investigated.~      A total of 189 subjects will participate in this trial. The entire study duration is about 9~     weeks with a 4-week screening period, 14-day treatment period and a follow-up period of about~     3 weeks.~   "
212441|NCT00779519|"~     Multiple pathways including peripheral and central hormones and neurotransmitters are~     involved in the regulation of food intake and body weight. One of the most studied pathways~     involves the melanocortin receptor. Agouti-related protein (AgRP) and alpha-melanocyte~     stimulating hormone (alphaMSH)have been shown to play an integral role in food intake and~     body weight.~      It is reasonable to speculate that if there is an imbalance of alphaMSH and AgRP exist in~     obese individuals and inhibiting the activity of AgRP may be of therapeutic benefit in~     treating obesity.~   "
212442|NCT00779506|"~     This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy~     and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment~     of acute schizophrenic patients. The eligible patient will be assigned to study treatment~     with Quetiapine XR on Day 1.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
212443|NCT00779493|"~     Evidence exists to support low-grade inflammation as the inciting factor leading to visceral~     hypersensitivity and alteration in motility in irritable bowel syndrome.In the medical~     literature,there is ample in vitro and in vivo evidence supporting turmeric and its~     derivative curcumin as an antitumor, anti-inflammatory and antioxidant agent. We propose a~     randomized, placebo-controlled, double blinded, parallel treatment study evaluating the~     effects of turmeric on the symptoms of irritable bowel syndrome.~   "
212444|NCT00779480|"~     To determine the maximum tolerated dose of KW-2449 in people with acute myelogenous leukemia~     who are not candidates for approved therapy. As well, the study will determine the response~     rate to KW-2449.~   "
212445|NCT00779467|"~     The purpose of this study is to see which dose of epidural neostigmine is the best additive~     to use with the numbing medication used in an epidural during labor.~   "
212446|NCT00779454|"~     The purpose of this study is partly to continue the good experience the investigators have~     with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding~     a biological antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral~     oncogene homolog (KRAS).~   "
212447|NCT00779441|"~     The study compared the relative bioavailability (rate and extent of absorption) of 10 mg~     Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg AmbienÂ® tablets distributed by~     Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult~     volunteers administered under non-fasting conditions~   "
212448|NCT00779428|"~     The primary purpose of this study is to provide treatment to patients who have participated~     on a prior protocol investigating Tanespimycin (KOS-953,17-AAG)~   "
212449|NCT00779415|"~     Patients diagnosed with partial thickness tears of the rotator cuff are sometimes surgically~     repaired, while other cases are not. It is unknown how patients fare over time without~     electing surgical repair and how outcomes differ by type of injury.~   "
212450|NCT00779402|"~     The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for~     patients with hormone sensitive prostate cancer. The study was conducted at over 15~     participating centers throughout the US. The purpose of the study was to determine if~     sipuleucel-T was effective for treatment of early stage, non-metastatic prostate cancer. The~     study compared the active vaccine to control to determine whether the product delayed the~     time until cancer progression.~   "
212451|NCT00779389|"~     The central hypothesis to be tested in this study is that dual blockade of EGFR and Src~     pathways or proteins are distinct compared to inhibition of either kinase alone in head and~     neck and lung cancers.~   "
212452|NCT00779376|"~     The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy~     and GlaxoSmithKline (Retrovir ®) 300 mg Zidovudine tablets, under fed conditions~   "
212453|NCT00779363|"~     The objectives of this feasibility study are to evaluate the safety and functionality of the~     TANTALUS System with TANTALUS II IPG, to assess the effect of GCM signal application on~     trends of HbA1c, blood glucose and body weight changes.~   "
212454|NCT00779350|"~     The purpose of this study was to evaluate the relative bioavailability of the test~     formulation of sertraline 100 mg tablets with an already marketed reference formulation~     Zoloft® 100 mg tablets (Pfizer), under fasted conditions in healthy male and female adult~     subjects.~   "
212455|NCT00779337|"~     This trial will use a new method of treating lymphoma using a therapy derived from a person's~     Killer T cells. These Killer T cells are taken from a person's blood and grown in a test tube~     to increase the number of these cells that are specifically active against the lymphoma~     cells. The cells are then given to the patient by intravenous infusion with the aim of~     killing the lymphoma cells. Potentially this treatment will help to kill the~     residual/recurrent tumour that is present after other lymphoma treatment and reduce the~     chance of the tumour recurring.~   "
212457|NCT00779311|"~     This research study is being performed at approximately 3 sites associated with Accelerated~     Community Oncology Research Network, Inc. (ACORN). Approximately 45 subjects will take part~     in this study.~      In this study, everyone will receive the same dose of mFOLFOX6 and Avastin. There will be~     five groups of subjects. Each group of subjects will receive a higher dose of Nexavar than~     the previous group. This will continue until a subject group has a major side effects from~     the dose they are given. This is so that the sponsor can determine the highest dose of~     Nexavar that can be used with mFOLFOX6 and AVastin (this is called the maximum tolerated dose~     or MTD).~   "
212458|NCT00779298|"~     Increased intake of dietary fibre and whole grains is related to reduced risk of developing~     diabetes. The term whole grain is often used for whole-meal products in which the structure~     of the cereal grain is destroyed in the flour containing the original dietary fiber, but also~     for cereal products in which a large proportion of whole cereal grains is intact. The aim of~     this study was to evaluate the effect of commercial rye whole-meal bread (RWMB) compared to~     white-wheat bread (WWB) on gastric emptying rate (GER), postprandial glucose response in~     healthy subjects.~   "
212459|NCT00779285|"~     The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with~     metastatic breast cancer who have previously received chemotherapy with anthracyclines.~   "
212460|NCT00779272|"~     The objective of this study is to evaluate for the first time not only the impact of~     neoadjuvant chemotherapy on clinical outcome, but also on liver regeneration after liver~     resection.~   "
212461|NCT00779259|"~     In a prior in vitro study using human hepatocytes quinine was shown to induce the activity of~     Cytochrome p450 CYP 1A2. The present study will evaluate the extent to which quinine~     sulfate-related induction of this enzyme effects the pharmacokinetics of theophylline, a~     sensitive probe drug for the activity of CYP 1A2. It will also evaluate the effect of~     single-dose theophylline on the pharmacokinetics of steady-state quinine sulfate.~   "
212462|NCT00779246|"~     This pilot study in our medical intensive care unit will evaluate the clinical and~     cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus~     aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate~     (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other~     hospital-acquired infections (e.g., catheter-associated bloodstream infections).~   "
212463|NCT00779233|"~     The purpose of this study is to evaluate the relative bioavailability of the test formulation~     of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg~     tablets (GlaxoSmithKline), under fasted conditions in healthy male and female adult subjects.~   "
212464|NCT00779220|"~     This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in~     combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data~     from this study will also be compared with those from a clinical study of ocrelizumab in~     patients with active RA that was conducted in the U.S.~   "
212465|NCT00779207|"~     The purpose of this study is to determine the effect of weight loss and exercise on liver and~     muscle fat.~   "
212466|NCT00779194|"~     Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown origin. It involves~     multiple organs including the joints, skin, kidneys and central nervous system. The disease~     process is caused by a dysfunction of the immune system. The drugs currently used for the~     treatment of SLE are only partially effective and carry significant risks for side-effects.~     Rapamycin, also called sirolimus or Rapamune, has been approved by the FDA to prevent~     rejection of organ transplants at daily doses of 2 mg to 8 mg. Patients that were resistant~     or intolerant to conventional medication have been effectively treated with Rapamycin and~     were able to decrease the amount of prednisone they needed.~      The purpose of this study is to prospectively determine the therapeutic efficacy and~     mechanism of action of Rapamune in patients with SLE. Healthy subjects not receiving Rapamune~     will be asked to donate blood to serve as controls.~      As part of the research effort to understand the reason for the variations in the effects of~     treatment drugs by different individuals, a sub-study of the DNA makeup of subjects enrolled~     in the trial will also be done. The purpose of the sub-study is to possibly determine whether~     different responses to the drugs used to treat SLE have a correlation with the differences in~     the genetic makeup of the subjects.~   "
212467|NCT00779181|"~     The purpose of this study is to determine a safe and effective dose of ADX415 for the~     treatment of hypertension.~   "
212468|NCT00779168|"~     RATIONALE: White button mushroom extract may stop or delay the development of recurrent~     prostate cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of white button~     mushroom extract in treating patients with recurrent prostate cancer after local therapy.~   "
212469|NCT00779155|"~     The purpose of this study is to determine if low level magnetic fields may help to relieve~     symptoms of Parkinson's disease.~   "
212470|NCT00779142|"~     It is well known that blindness is one of the most feared disabilities expressed by patients~     in the United States. Estimates of the economic impact of visual disability in the current~     population exceed 30 million US dollars in this country alone. The reasons for this figure~     are many; however age related macular degeneration (ARMD), diabetic retinopathy, glaucoma and~     uveitis are responsible for the majority of permanent visual disability and hence the costs~     in both quality of life and placing an economic burden on society. Research that may help~     reverse various abnormal biological responses that lead to or worsen clinical manifestations~     of diabetic retinopathy would be valuable.~   "
212471|NCT00779129|"~     Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin~     or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate~     the safety and efficacy of Caelyx in combination with cyclophosphamide in women with~     metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.~   "
212472|NCT00779116|"~     This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab~     2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg~      Chewable Tablet). Subject preference for one product or the other was determined.~     Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a~     smile face scale.~   "
212473|NCT00779103|"~     The purpose of this study is to follow and collect additional medical and developmental~     information on children after histrelin subcutaneous implant therapy is discontinued.~   "
212474|NCT00779090|"~     In ventilated patients open endotracheal suctioning may lead to alveolar derecruitment, which~     can be monitored by means of functional residual capacity (FRC) measurements. The~     investigators hypothesized that a recruitment strategy based on FRC measurements would~     improve oxygenation and regional ventilation after an open endotracheal suctioning manoeuvre.~   "
212475|NCT00779077|"~     We wish to measure the inspiratory flow and volumes generated by the subjects inhaling from a~     spirometer with a high resistance dry powder inhaler in series in subjects with cystic~     fibrosis.~   "
212476|NCT00779064|"~     This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety~     of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).~   "
212477|NCT00779051|"~     The study compared the relative bioavailability (rate and extent of absorption) of 10 mg~     Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by~     Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult~     volunteers administered under fasting condition~   "
212478|NCT00779038|"~     The purpose of this study is to evaluate in daily clinical practice the safety and efficacy~     of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of~     moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe)~     pain in participants who have undergone elective spine or orthopedic (related to bones)~     surgery.~   "
212479|NCT00779025|"~     The purpose of this study is to study in couples and to evaluate the safety of personal~     lubricant products.~   "
212480|NCT00779012|"~     The objective of this study is to prove reasonability of registration in Russian federation~     this new indication (ankylosing spondylitis [AS]) through evaluation of safety and efficacy~     rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by~     additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to~     8 weeks (maximum 9 infusions).~   "
212481|NCT00778999|"~     The success of assisted reproductive technologies (ART) is critically dependent on optimizing~     protocols for controlled ovarian stimulation to provide adequate numbers of good quality~     oocytes and embryos. This optimization is mainly valuable to a group of infertility patients~     (9%-24%) who respond poorly to Controlled Ovarian Stimulation(COS). It is also important for~     an additional 2.6% of the infertility patients who manifest a high response to gonadotropin~     and are at risk for hyperstimulation syndrome, a life-threatening situation. Extensive~     research was carried out and led to the introduction of GnRH antagonist, as an alternative to~     Gonadotropin Releasing Hormone (GnRH) agonist, for the prevention of premature Luteinizing~     Hormone (LH) surges. Further research to optimize the GnRH antagonist regimen concluded that~     a daily treatment with 200 IU of recombinant Follicle Stimulating Hormone (recFSH) in a GnRH~     antagonist regimen is safe, well tolerated and results in a good clinical outcome. This~     protocol is now frequently applied in the US and Europe.~      Predicting a woman's response (based on the assessment of ovarian reserve) to COS is useful~     in determining individualized clinical management strategies for low and high responders and~     thus avoiding cancellation. Such prediction when based on reliable scientific evidence is~     valuable in consulting patients about their chances of success. A large number of studies~     have been performed, which used certain clinical, ultrasonographic and hormonal markers~     (called predictive factors), to try to optimize a COS protocol for patients who were~     down-regulated with a long GnRH agonist protocol. Prospective trials of predictive models~     have also been used to adjust the starting dose of FSH to prevent a too low or too high~     ovarian response. To date, however, none have been performed for women undergoing ovarian~     stimulation with a GnRH antagonist protocol.~      The primary objective of this randomized, open-label, multicenter clinical trial was to~     identify one or more factors capable of predicting ovarian response in women treated with a~     daily dose of 200 IU recFSH in a GnRH antagonist protocol. Since many ART centers now use~     oral contraceptives as a means to schedule patients stimulated with recFSH and a GnRH~     antagonist for assisted reproduction, the trial evaluated also whether intervention with oral~     contraceptives affects the accuracy of predictive models for ovarian response.~   "
212482|NCT00778986|"~     The purpose of this randomized controlled trial is to determine the effects of a user-centric~     remote patient monitoring system on heart failure management. Patients attending a Heart~     Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The~     hypothesis is that the remote monitoring system will improve heart failure outcomes through~     increased self-care and improved clinical management.~   "
212483|NCT00778973|"~     The purpose of this study was to evaluate the relative bioavailability of the test~     formulation of sertraline 100 mg tablets with an already marketed reference formulation~     Zoloft® 100 mg tablets (Pfizer), under non-fasting conditions in healthy male and female~     adult subjects.~   "
212484|NCT00778960|"~     The purpose of this study is to find out how meditation influences certain systems in the~     body: nervous system, hormonal system, and respiratory system. Another purpose is to see how~     meditation may help improve post-traumatic stress disorder symptoms.~   "
212485|NCT00778947|"~     The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy~     Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to~     conventional diathermy in terms of improving ease and speed of perforator dissection,~     reducing postoperative pain, days of hospital stay and time taken to return to daily~     activities.~   "
212486|NCT00778934|"~     The purpose of this study is to evaluate the effects of an intimate health product on sexual~     experience in females.~   "
212487|NCT00778921|"~     This study will assess the safety and efficacy of combination aliskiren/amlodipine in~     patients with hypertension not adequately controlled with amlodipine alone.~   "
212488|NCT00778908|"~     Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal~     carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that~     intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing~     daily dose starting at the fifth week after initiation of IMRT might improve tumor control~     and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The~     study is designed to test if late-course accelerated hyperfractionated IMRT can improve the~     outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with~     locoregionally advanced nasopharyngeal carcinoma.~   "
212489|NCT00778895|"~     Children younger than 5 years of age are at high risk for severe influenza disease (flu) and~     hospitalization due to flu. Scientists are in the process of re-evaluating the dosing~     initially based on whole virus vaccines to improve their efficacy in infants. In this study,~     we will compare two different dose levels of GSK1557482A flu vaccine. Another already~     approved flu vaccine made by a different company will be used as a control.~   "
212490|NCT00778882|"~     The purpose of this study is to evaluate the safety and efficacy of administration of~     autologous hematopoietic stem cells transduced with MT-gp91 retroviral vector for patients~     with X-linked chronic granulomatous disease.~   "
219208|NCT00689702|"~     This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added~     to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced~     primary resectable rectal cancers.~   "
212491|NCT00778869|"~     This is an open-label, controlled sub-study to the parent protocol (P04041, NCT00779935) to~     examine the expression profile of genes in patients in the active stage of ankylosing~     spondylitis (AS) compared to the healthy population as control, moreover to examine the~     changes in expression profile during anti-tumor necrosis factor (TNF)-alpha treatment~     (Remicade).~   "
212492|NCT00778856|"~     Organ transplantation has become the treatment of choice for most patients suffering end~     stage diseases of the kidney, pancreas, liver, heart or lung.~      Vascularized Composite Allotransplantation (VCA) {a.k.a. composite tissue~     allotransplantation} is the term used to describe transplantation of multiple tissues (skin,~     muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit (e.g. hand). Several~     recent advances in clinical organ transplant immunosuppression and experimental limb VCA have~     now made it feasible to consider clinical VCA for the functional restoration of patients with~     loss of one or both hands.~      This protocol facilitates the development of limb VCA at the Atlanta Veterans Affairs Medical~     Center (VAMC) and at Emory University for patients with below the elbow amputations. It will~     evaluate the patients' use of transplanted limb(s) in activities of daily living and compare~     the function of the transplanted hand to the function with their previous prosthesis.~      Patients with below the elbow amputations will be enrolled. Donor tissue will be recovered~     from deceased donors following the guidelines of and in cooperation with the regional Organ~     Procurement Organization. The transplantation procedure and postoperative care will be~     performed using the standard technique for limb replantation. Patients will receive standard~     immunosuppressive regimen. Rejections will be treated in keeping with experience from the~     solid organ transplant experience. Graft failure will be treated with allograft amputation.~   "
212493|NCT00778843|"~     The pathogenesis of chronic hepatitis C (CHC) is associated to severe oxidative stress and~     non-selective immunological disturbance that leads to necro-inflammation and progression of~     fibrosis. Previous trials suggested that antioxidant and inmunostimulant therapies may have a~     beneficial effect. The purpose of the study is to evaluate whether Viusid, a nutritional~     supplement with hepatoprotective properties, could ameliorate the oxidative stress and~     modulate the immune response in patients with CHC and non-responders to pegylated interferon~     plus ribavirin, during 24 weeks of treatment.~   "
212494|NCT00778830|"~     This is an open-label, non-randomized, multicenter Phase II study evaluating folinic acid +~     fluorouracil + irinotecan (FOLFIRI) plus cetuximab (Erbitux) or folinic acid + fluorouracil +~     oxaliplatin (FOLFOX) plus cetuximab as first-line therapy of patients with KRAS wild-type~     metastatic colorectal cancer.~      Only subjects with k-ras oncogene (KRAS) wild-type tumors are eligible. Efficacy will be~     assessed every 8 weeks. Treatment will be continued until progressive disease or unacceptable~     adverse events occur. After the end of study treatment, information on further anticancer~     treatment and survival will be collected every 3 months.~   "
212495|NCT00778817|"~     This randomized phase II trial is studying mitotane and IMC-A12 to see how well they work~     compared with mitotane alone in treating patients with recurrent, metastatic, or primary~     adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as~     mitotane, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as IMC-A12, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them. It is~     not yet known whether mitotane is more effective with or without monoclonal antibody IMC-A12~     in treating adrenocortical cancer.~   "
212496|NCT00778804|"~     The study will evaluate the impact of an internet based telemedicine system on cardiovascular~     risk profile of underserved patient populations. It is our hypothesis that a treatment plan~     and frequent communication via an internet based Telemedicine system will improve the~     cardiovascular risk profile of underserved patient populations at increased risk for~     cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD~     risk score (ATP III risk model).~   "
212497|NCT00778791|"~     The objective of this study is to compare the relative bioavailability of metformin HC1 750~     mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol~     Myers Squibb) in healthy, adult, subjects under fasting conditions.~   "
212498|NCT00778778|"~     The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy~     and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fasting~     conditions.~   "
212499|NCT00778765|"~     To compare the single-dose oral bioavailability of metformin HCI liquid 500 mg/5 mL of~     Ranbaxy with Glucophage® 1000 mg tablets of Bristol-Myers, USA following administration of a~     1000 mg dose in healthy, adult, male and female volunteers under fasting conditions~   "
212500|NCT00778752|"~     This study is a Phase I (non-randomized) study evaluating three dose-levels of Lenalidomide~     in patients after allogeneic stem cell transplantation, accomplished in two institutions~     (University Medical Center Hamburg-Eppendorf/ University Medical Center Heidelberg).~   "
212501|NCT00778739|"~     The study was conducted as an open-label, randomized, 2-way crossover study to compare the~     single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil~     TM Powder for Oral Suspension (250 mg/5 mL) following one 5 mL dose under fed conditions~   "
212502|NCT00778726|"~     The purpose of this study was to determine the bioavailability of benazepril and~     hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration~     of single doses to normal healthy fasted subjects. These data were to be evaluated~     statistically to determine if the products meet bioequivalence criteria.~   "
212503|NCT00778713|"~     The objective of this study is to compare the relative bioavailability of Fosinopril sodium~     and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited with that of~     Monopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1~     x 20/12.5 mg tablet) in healthy adult subjects under non-fasting conditions.~   "
212504|NCT00778700|"~     The study will be a double-blind, randomized, vehicle-controlled study with application of~     INCB018424 phosphate cream or vehicle in patients with stable plaque psoriasis. Application~     will be QD for 12 weeks without occlusive dressings. There will be 4 treatments of 50~     subjects each.~   "
219209|NCT00689689|"~     The purpose of this study is to answer the question as to whether or not a fully coated~     cementless stem is equal to or better than a cemented stem in patients over 72 years with~     good bone quality.~   "
212505|NCT00778687|"~     Cirrhotic cardiomyopathy describes a hyperdynamic state with the presentation of high cardiac~     output and low systemic vascular resistance. And the latent heart failure becomes obvious~     under physiologic and pharmacologic stress. The goal of our study is to assess the effects of~     liver transplantation on the heart rate variability in patients with end stage liver disease.~   "
212506|NCT00778674|"~     The purpose of this study was to determine the bioavailability of Benazepril and~     hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration~     of single doses to normal healthy subjects under fed conditions. These data were to be~     evaluated statistically to determine if the products meet bioequivalence criteria.~   "
212507|NCT00778661|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg~     clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet~     dose under fasting conditions~   "
212508|NCT00778648|"~     The primary objective of this study is to determine the effect of an encapsulated juice~     powder concentrate on the number of days with at least moderate common cold symptoms over~     winter time.~   "
212509|NCT00778622|"~     The purpose of this study is to investigate the effect of the baseline body mass index (BMI)~     on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with~     newly diagnosed type 2 diabetes~   "
212510|NCT00778609|"~     The aim of the present study is to investigate whether women taking a new combined oral~     contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone~     withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle~     compared to a commonly used contraceptive pill (Microgynon).~   "
212511|NCT00778596|"~     Study purpose:~      To investigate whether ALT rebound following corticosteroid priming enhances response to~     telbivudine therapy.~      Efficacy assessments:~      The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without~     prednisolone priming.~      Data analysis:~      A summary table will be presented as frequency tables for categorical variables as number,~     and percentage, whereas descriptive tables for continuous variables as number, mean ± SD and~     median (minimum, maximum). All statistical assessments will be two-sided and evaluated at~     significance level of 0.05. Continuous variables will be analyzed using t-test, or ANOVA, and~     categorical variables will be analyzed using chi-square or Fisher's exact test. A~     non-parametric method, Wilcoxon rank-sum or sign-rank tests will be conducted for continuous,~     and categorical variables if data is far from normal distribution.~   "
212512|NCT00778583|"~     An open label, randomised, two-treatment, four-period, two-sequence, single-dose, crossover,~     fully replicated bioavailability study on Nitrofurantoin formulations comparing~     Nitrofurantoin 100 mg capsules of Ranbaxy Laboratories with Macrobid 100 mg capsules in~     healthy, adult, human subjects under fed conditions~   "
212513|NCT00778570|"~     The purpose of this combined retrospective and prospective chart review analysis is to~     investigate the safety, efficacy, and predictability obtained via Laser-Assisted In Situ~     Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) over a wide range of refractive~     errors~      The working hypothesis is that there will be no difference in clinical outcomes between~     patients treated with LASIK or ASA.~   "
212514|NCT00778557|"~     The study was conducted as a blinded, randomized, 3-way crossover study to compare the~     single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil~     TM Powder for Oral Suspension (250 mg/5 mL) following one 5 mL dose under fasting conditions~   "
212515|NCT00778544|"~     The objective of this study was to compare the rate and extent of absorption of Ranbaxy~     Laboratories Limited, India, Amoxicillin-Clavulanic acid and GlaxoSmithKline, U.S.A.~     (Augmentin ES-600), amoxicillin-clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9~     mg) oral suspension, under fed conditions.~   "
212516|NCT00778531|"~     The purpose of this post-approval study is to evaluate the continuing safety of ArteFill as~     an injectable implant for correction of nasolabial folds over the course of five years post~     implantation, with a focus on determining the incidence of granuloma formation. Incidence of~     adverse events and subject satisfaction with respect to the subject's personal expectations~     will be assessed.~   "
212517|NCT00778518|"~     Study to find the optimal dose of Growth Hormone Replacement in young adult patients~     suffering from childhood onset growth hormone deficiency (GHD).~   "
212518|NCT00778505|"~     To compare manual administration of propofol and remifentanil and dual closed-loop using~     bispectral index as the control variable during pediatric anesthesia~   "
212519|NCT00778492|"~     Study Objective is to correlate the results of preoperative platelet mapping derived from~     modified TEG with clinically significant postoperative bleeding and consumption of blood~     products.~   "
212520|NCT00778479|"~     This study will examine the Performance of Sepraspray in Patients undergoing open abdominal~     surgery~      NOTE regarding reason for study termination:~      A patient death reported during the trial warranted temporary suspension for review by the~     independent data review committee. Although the committee recommended continuing enrollment,~     enrollment was electively terminated by the sponsor.~      A preliminary analysis did not identify any new risk that was not listed on the~     investigational labeling for this product. A full analysis of the results is expected to~     allow characterization of the risk/benefit and clinical utility of the product in the exposed~     patient population.~   "
212521|NCT00778466|"~     The objective of this study was to evaluate the relative bioavailability of the test~     formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference~     formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb~     Company) under fed conditions in healthy, male and female adult subjects.~   "
212522|NCT00778453|"~     The findings of this study will advance movement reorganization mechanism underlying~     treatment approaches and clinical intervention techniques. These findings may inform~     rehabilitation professionals about which treatment approach is superior to another one in~     certain aspect of outcome and who can benefit most from certain treatment approach.~     Accordingly, the results of this project may help us move quickly to design and develop~     efficient and effective rehabilitation programs for individualized patients.~   "
219213|NCT00689637|"~     The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or~     not, i.e. show the same or altered plasma concentration profiles when co-administered~     compared to administered alone.~   "
212523|NCT00778440|"~     Main objectives:~        -  To know the distribution of risk elements of traffic injuries~      Secondary objectives:~        -  To study the distribution of risk elements related with the possibility of suffering~          from a TI in relation to medication, chronic health problems, and consumption of~          psychoactive substances (alcohol and others).~        -  To know the relation between levels of perception of risk of suffering from a TI and the~          presence of chronic problems, medications, or consumption of psychoactive substances.~   "
212524|NCT00778427|"~     The objective of this study was to evaluate the relative bioavailability of the test~     formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference~     formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb~     Company) under fasted conditions in healthy, male and female adult subjects.~   "
212525|NCT00778414|"~     The objective of this study was to compare the rate and extent of absorption Ranbaxy~     Laboratories Limited, India, amoxicillin - clavulanic acid and GlaxoSmithKline, U.S.A.~     (Augmentin ES-600), amoxicillin - clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9~     mg) oral suspension, under fasting conditions.~   "
212526|NCT00778401|"~     This study compared the relative bioavailability (rate and extent of absorption) of the test~     Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg~     tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of~     Warner-Lambert Co. in 28 healthy, adult subjects (21 males and 7 females) under fasting~     conditions using randomized, two-way crossover design.~   "
212527|NCT00778388|"~     The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and~     tolerability.~   "
212528|NCT00778375|"~     The goal of this clinical research study is to learn if clofarabine given in combination with~     cytarabine and decitabine can help to control the disease in patients with AML or MDS who are~     60 years old or older. The safety of this treatment will also be studied.~   "
212529|NCT00778362|"~     The spleen may be removed due to benign hematologic disorders, such as idiopathic~     thrombocytopenic purpura and hereditary spherocytosis, or malignancies, such as lymphomas and~     leukemias. Splenectomy may also be performed due to splenic traumas or in association of some~     surgical procedures, when combined splenectomy will make the operations easier. The most well~     known procedure is distal pancreatectomy combined with splenectomy.~      In this research, there are two main goals. Firstly, establish the data about the incidence~     of overwhelming postsplenectomy infection (OPSI) in our country. Currently, the western data~     of the incidence, morbidity rate and mortality rate of OPSI is well established and~     vaccination along with prophylactic antibiotics is strongly recommended. Since the incidence~     of OPSI in our country isn't clear, most (>95%) splenectomized patients in our hospital~     (National Taiwan University Hospital) did not have vaccination or prophylactic antibiotics.~     We'll try to determine the incidence of OPSI by reviewing of our hospital charts and by~     structured interviews with patients.~      The spleen is a phagocytic filter. So asplenic patients have higher risks of getting~     infection and some spleen-preserving procedures are proposed. In our initial experiences,~     distal pancreatectomy with splenic artery and vein divided could be safely performed and~     greatly increased the possibility of preservation of spleen. However, when the spleen was~     preserved with dividing the splenic artery and vein, the blood supply to the spleen will be~     shifted from splenic artery to short gastric artery. Although a substantial immunologic~     advantage exists if splenic tissue remains, this may not offer sufficient protection from~     encapsulated bacteria if splenic arterial blood flow is reduced because experimental animal~     studies have demonstrated that an intact splenic arterial system is necessary for optimal~     control of infection. Thus, although the spleen is preserved in above mentioned procedure,~     the function of the preserved spleen is questionable and has never been studied of. Our~     second object is to determine the splenic function after after spleen-preserving distal~     pancreatectomy with excision of splenic artery and vein by comparison of abdominal computed~     tomography and immunological function of patients before and after operation. Besides, we'll~     designed an animal experiment to examine the rate of pneumococcal clearance by the spleen and~     to determine the relationship between splenic blood flow and splenic tissue mass in bacterial~     clearance from the blood when the splenic vessels were divided.~   "
212530|NCT00778349|"~     To assess the food effect on pharmacokinetic profile of metformin liquid 100 mg/mL of Ranbaxy~     Laboratories in healthy, adult, human subjecis following a dose administration of 10 mL (1000~     mg) under fasting conditions, after a Iow fat meal and after a high fat meal~   "
212531|NCT00778336|"~     This registry collects observational data about how mid-length AngioJet catheters (ie~     XPEEDIOR and DVX models) are used in routine clinical practice.~   "
212532|NCT00778323|"~     The purpose of this study is to assess whether a large clinical trial testing the effect of~     RIPC on neurologic outcome in patients undergoing elective cervical decompression surge is~     warranted.~   "
212533|NCT00778310|"~     A number of brain regions have been down to be altered in both structure and function in~     patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum.~     Patients with ADHD often show reduced levels of activity in the frontal and cingulate regions~     of brain while performing measures of inhibitory control during functional magnetic resonance~     imaging (fMRI). While stimulant medications robustly improve the clinical symptoms of ADHD,~     there are only a small number of studies examining the effects of these commonly prescribed~     medications on brain activity. We propose to obtain fMRI in patients with ADHD on placebo and~     on their individualized dose of OROS methylphenidate (Concerta). Our hypothesis is that~     Concerta will increase the activity of the brain in the frontal, cingulate and amygdala of~     the brain and that these brain changes will be associated with clinical improvement of~     symptoms.~   "
212534|NCT00778297|"~     This is a single blind, reference drug controlled, one center viral immunogenicity and~     tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos~     antigen content to assess immunogenicity and tolerability.~      The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004~     trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age~     groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability~     of the study drug according to CPMP/BWP/214/96: Note for Guidance on Harmonization of~     Requirements for Influenza Vaccines, 12 March 1997.~   "
212535|NCT00778284|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg~     clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet~     dose under fed conditions~   "
212536|NCT00778271|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin, following administration of a 400 mg~     dose under fasting conditions~   "
212537|NCT00778258|"~     The purpose of this study is to determine if children who are allergic to milk can increase~     tolerance through frequent dose-escalation every 6 months versus 12 months leading to~     eventual tolerance of less heated milk and ultimately unheated milk.~   "
212538|NCT00778245|"~     The objective of this study is to assess the single - dose relative bioavailability of~     Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed~     conditions.~   "
212539|NCT00778232|"~     This study compared the relative bioavailability (rate and extent of absorption) of~     Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited with that of Neurontin ® 800 mg~     tablets of Parke Davis Pharmaceuticals Ltd. Distributed by Parke-Davis, division of~     Warner-Lambert Co. following a single oral dose (1x800 mg tablet) in healthy adult volunteers~     under non-fasting conditions.~   "
212540|NCT00778219|"~     60 patients, in three group of 20 patients each, scheduled for surgery needing general~     anesthesia will be researched. Group A: tracheal intubation of single lumen tube using~     laryngoscope. Group B: single lumen tube using lightwand. Group C: double lumen endobronchial~     cath. During general anesthesia, the spectral power of heart rate variability at three~     periods: (1) preoperation baseline (2) pre-intubation and (3) post-intubation will be~     calculated and compared to investigate the autonomic stimulation effect of different tracheal~     intubation methods.~   "
212541|NCT00778206|"~     The objective of this study is to evaluate the safety of long-term treatment with Kuvan.~   "
212542|NCT00778193|"~     Gastroduodenal ulcers are extremely common in the community today. Though much has been~     written and observed concerning how ulcers form, not much has been described in the human~     model concerning how these ulcers heal. As numerous patients already suffer from~     gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the~     treatment and management of these patients. The goal of this study is to investigate the~     effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal~     lesions in order to elucidate the mechanisms of ulcer healing. This single site,~     single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer~     healing through endoscopic, immunohistologic, and molecular PCR modalities.~   "
212543|NCT00778180|"~     The purpose of this study was to evaluate the relative bioavailability of the test~     formulation of furosemide 80 mg tablets (Ohm Laboratories, Inc.) with an already marketed~     reference formulation Lasix® (furosemide) 80 mg tablets (Aventis Pharmaceuticals NJ) under~     fasted conditions in healthy adult human subjects~   "
212544|NCT00778167|"~     This randomized phase I/II trial is studying the side effects and best dose of cixutumumab~     and to see how well erlotinib hydrochloride works when given together with or without~     cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer.~     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. It is not yet known~     whether erlotinib hydrochloride is more effective when given together with or without~     cixutumumab in treating non-small cell lung cancer.~   "
212545|NCT00778154|"~     Patients who have received the appropriate number of years of alendronate or risedronate~     therapy will be recruited. Each patient will have received baseline BMD measurements~     performed at the spine and the hip by DXA. Each patient will receive tetracycline to label~     the bone and then have a transiliac bone biopsy. One year later teh bone label and biopsy~     procedure will be repeated.~   "
212546|NCT00778141|"~     The objective of this study is to compare the relative bioavailability of metformin HC1 750~     mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol~     Myers Squibb) in healthy, adult, subjects under non-fasting conditions.~   "
212547|NCT00778128|"~     At step 1, patients with advanced solid tumors will receive CP-4126 capsules following a dose~     escalation schedule until the maximum tolerated dose is reached. At step 2, 20 patients will~     be randomized. They will receive at days 1 and 8 in a double cross design either oral CP-4126~     at the recommended dose or gemcitabine 1000mg/m2 intravenously. At both steps, the schedule~     of treatment will be day 1, 8, 15 q4w until complete response or disease worsening/~     progressing. All further treatment at step 2 will be oral CP-4126.~   "
212548|NCT00778115|"~     The objective of this study is to compare the relative bioavailability of Loperamide HCl 2 mg~     and simethicone 125 mg tablets (Ranbaxy) with that of Imodium® Advanced caplets (McNeil) in~     healthy subjects under fasting condition~   "
212549|NCT00778102|"~     This 2 arm study will compare the resection rate of liver metastases and safety of surgery in~     patients with metastatic colorectal cancer and primarily unresectable liver metastases~     receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with~     irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients~     will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of~     these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment~     is until surgery, disease progression, unacceptable toxicity or patient refusal, and the~     target sample size is <100 individuals.~   "
212550|NCT00778089|"~     The purpose of this study is to assess the clinical utility of the ArteFill® pre-treatment~     Skin Test in predicting and preventing hypersensitivity reactions to treatment with ArteFill®~     implant~   "
212551|NCT00778076|"~     The purpose of this study is to determine the impact of a regular course of treatment with~     Hyaluronic acid (HA) injections on gait in knee osteoarthritis (OA) patients. Three~     consecutive HA injections will be compared to three consecutive placebo injections to~     determine whether HA's analgesic effect is greater than that of a placebo injection, and to~     observe whether HA's viscoelastic properties are manifested in a human knee OA population. We~     hypothesize that HA injections will relieve pain to a greater extent than placebo injections~     in knee OA patients, and will afford them with improved walking characteristics, such as~     increased walking speed, and step length.~   "
212552|NCT00778063|"~     The purpose of this study is to evaluate the use of intranasal dexmedetomidine to reduce the~     incidence of emergence delirium during general sevoflurane anesthesia in a pediatric~     population receiving pressure equalization tubes in one or more ear.~   "
212553|NCT00778050|"~     This study compared the relative bioavailability (rate and extent of absorption) of~     amoxicillin tablets for oral suspension 600 mg by Ranbaxy Laboratories Limited with that of~     Amoxil ® for oral suspension 400 mg/ 5 mL by SmithKline Beecham Pharmaceuticals following~     single oral dose (600 mg) in healthy, adult, subjects under fasting conditions using a~     randomized two-way crossover design.~   "
212700|NCT00776048|"~     This study is being conducted to compare healthy patients versus patients with muscle~     tightness in their leg(s) after an acquired brain injury using walking trials time, a balance~     test, and foot pressure data. This data is obtained using foot pressure sensors, timers, and~     distance walked.~   "
212554|NCT00778037|"~     To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet~     of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg~     tablet (containing Cyclobenzaprine hydrochloride 10 mg) of McNeil Consumer & Specialty~     Pharmaceuticals, in healthy, adult, male, human subjects under fasting condition.~   "
212555|NCT00778024|"~     The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40~     mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista~     Products Company) following a single oral dose (1 x 40 mg capsule) in healthy, adult subjects~     under fasting conditions~   "
212556|NCT00778011|"~     Nausea and vomiting is a common complaint in the emergency department. Treatment is important~     for many reasons. In addition to patient comfort, there are adverse effects secondary to~     vomiting such as dehydration, metabolic alkalosis, Mallory-Weiss tears, and aspiration. Two~     mediations common used for nausea in ED patients include Ondanesetron and Metoclopramide.~   "
212557|NCT00777998|"~     The present study will be a multicenter, prospective phase II-study investigating safety and~     efficacy of the combination of auto-allo tandem stem cell transplantation in patients with~     multiple myeloma and age of >_60 years, followed by maintenance therapy with low-dose~     Thalidomide and Donor Lymphocyte Infusions.~   "
212558|NCT00777985|"~     The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal~     continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference~     treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.~      The hypothesis is that blocking endothelin receptors with a drug will have the same systemic~     blood pressure lowering effect than nCPAP in sleep apnea patients.~   "
212559|NCT00777972|"~     The objective of this study was to compare the relative bioavailability of Fosinopril sodium~     and hydrochlorothiazide 20-12.5 mg tablets by Ranbaxy Laboratories Limited with that of~     Monopril ®.-HCT 20-12.5 mg tablets by Bristol-Meyers Squibb following a single oral dose (1 x~     20-12.5 mg tablet) in healthy adult subjects under fasting conditions~   "
212560|NCT00777959|"~     This study will look to see if the combination of ridaforolimus and bicalutamide works better~     than placebo and bicalutamide in men with prostate cancer.~   "
212561|NCT00777946|"~     This study will assess the safety and efficacy of combination aliskiren/amlodipine in~     patients not adequately controlled with aliskiren alone~   "
212562|NCT00777933|"~     The use of steroids after kidney transplantation has been challenged because of variable~     adverse effects which may increase the patient morbidity and mortality. The aim of this study~     was to compare the safety and efficacy of immunosuppressive regimens consisting of~     cyclosporine (CsA) and mycophenolate mofetil (MMF) or tacrolimus (TAC) and MMF after steroid~     withdrawal 6 months after kidney transplantation in low-risk patients.~   "
212563|NCT00777920|"~     This Phase 3, international, multicenter, open-label study will monitor the long-term safety~     of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for~     this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan~     in the United States, Canada, and the European Union are 5 and 10 mg. Investigators will be~     able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose~     adjustments is required. Participants receiving other therapies for pulmonary hypertension~     that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in~     this study and continue to receive such therapies. Participants enrolled in this study will~     receive treatment with ambrisentan until such time as the investigator or participant chooses~     to stop ambrisentan treatment, ambrisentan becomes commercially available, or the Sponsor~     stops the study.~   "
212564|NCT00777907|"~     To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization~     for the treatment of coilable wide-necked intracranial aneurysms~   "
212565|NCT00777894|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. This may be an~     effective treatment for liver cancer.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of external-beam~     radiation therapy in treating patients with liver cancer that cannot be removed by surgery.~   "
212566|NCT00777868|"~     The purpose of this study is to assess the safety and effectiveness of two concentrations of~     IDP-108 in treating patients with onychomycosis~   "
212567|NCT00777855|"~     The purpose of this study is to determine the importance of uptake drug transporters in the~     drug disposition of warfarin. We predict that the elimination of warfarin will be decreased~     when co-dosed with an inhibitor of uptake drug transporters.~   "
212568|NCT00777842|"~     The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a~     lesion in the coronary artery.~   "
212569|NCT00777829|"~     This study will examine whether various drugs affecting sleep cycles can improve different~     kinds of memory.~   "
212570|NCT00777816|"~     Study X052070 will evaluate the safety and pharmacokinetics (PK) of XOMA 052 administered to~     patients with active, stable, moderate to severe rheumatoid arthritis (RA).~      It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control~     in subjects with RA.~   "
212571|NCT00777803|"~     NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A~     preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201~     causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used~     for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This~     study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with~     OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.~   "
212572|NCT00777790|"~     This study was designed to evaluate the antibody response to a Menactra® booster dose in~     participants who previously received one dose of Menactra® or Menomune® as adolescents 3~     years earlier in Study MTA02.~      Primary Objective:~      To evaluate the antibody responses to a booster dose of a tetravalent meningococcal~     diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received~     Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of~     Menactra® in naive adolescents.~   "
212573|NCT00777777|"~     Prospective, multi-center, randomized, controlled (patients as their own control) trial on an~     external mesh device (eSVS™, Kips Bay Medical) supporting saphenous vein grafts for coronary~     bypass graft surgery in patients with multi-vessel coronary heart disease.~   "
212574|NCT00777764|"~     This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of~     60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in~     two successive cohorts of subjects, healthy volunteers and patients with allergic asthma~     without prior exposure to omalizumab, according to a skin test protocol, consisting of a~     prick skin test and/or intradermal test.~   "
212575|NCT00777751|"~     The goal of this clinical research study is to learn if the radiation that you are receiving~     will result in an increase in certain proteins produced by the heart called cardiac~     biomarkers.~   "
212576|NCT00777738|"~     This trial is designed to evaluate the efficacy and toxicity of Bortezomib , an inhibitor of~     proteasome used in multiple myeloma, in patients with advanced Waldenström's~     Macroglobulinemia disease.~   "
212577|NCT00777725|"~     This study will involve 70 patients who attend the Alfred Hospital with acute or chronic~     heart failure as well as 30 age and gender matched control subjects. All participants will~     have their history taking and a physical examination to detect symptoms and signs of heart~     failure.~      The main objectives are for determining the benefit and usefulness of Fibroscan (Liver scan)~     in detecting liver stiffness (a condition caused by excess fluid build up in the liver which~     has a negative impact on the livers ability to function properly) in heart failure patients~     and for characterizing the incidence and severity of liver stiffness in this group of~     patients.~      After informed consent, a blood sample will be taken from all patients to assess their full~     blood examination, glucose, lipid profiles, renal function and so on.~      Then 24-48 hours after enrollment, the liver doctors will do the liver scan (Fibroscan) by~     transient elastography. All the data are recorded and further analysis will be assessed.~      In a small group of acute patients the blood tests and liver scan will be repeated just prior~     to their discharge.~      Optional Sub-study: For participants who consent to the optional sub-study another 20 ml of~     blood for serum liver fibrotic markers will be collected.~   "
212578|NCT00777712|"~     The overall aim of this research is to utilize wound derived inflammatory cells from diabetic~     versus non diabetic human chronic wounds to understand mechanisms that are responsible for~     disregulated inflammation in individuals with diabetes. Biology of normal (peripheral blood~     derived cells) versus wound derived cells will also be studied.~   "
212579|NCT00777699|"~     The purpose of this study is to evaluate the safety and tolerability of XL765 in combination~     with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that~     inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been~     shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas~     inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an~     orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved~     by the FDA as a single agent for the treatment of patients with locally advanced or~     metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior~     chemotherapy regimen and in combination with gemcitabine for first line treatment of patients~     with locally advanced, unresectable or metastatic pancreatic cancer.~   "
212580|NCT00777686|"~     The goal of this clinical research study is to learn if magnetic resonance imaging with~     magnetic resonance spectroscopy (MRI/MRS scanning) can measure any extra growth in the~     tumor that does not show up on regular MRI images. This study procedure will be performed on~     patients with recurrent glioblastoma who are either being treated with chemotherapy that~     blocks blood vessel growth, or will soon begin this type of chemotherapy.~   "
212581|NCT00777673|"~     The purpose of this study is to determine how well this combination of chemotherapy drugs~     works with bevacizumab in eliminating primary tumor in the breast prior to~     surgery(pathological complete response or pCR in the breast). Bevacizumab is a drug that~     works by blocking new blood vessel formation by the tumor cells. Giving chemotherapy and~     bevacizumab before surgery may allow for lesser amount of breast tissue to be removed. To be~     able to predict in the future which patients are more likely to get pCR to this drug~     combination, specialized tests on tumor tissue will be performed.~   "
212582|NCT00777647|"~     Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation~     leading to obesity development. Although drinks sweetened with aspartame are available the~     anticipated positive effect of these drinks on obesity development has not been convincing.~     However, the mechanisms linking drinks intake to obesity are yet to be clarified.~      The investigators aim is to investigate the long-term effects of intake of soft drinks, milk~     and water. The study is a parallel, intervention trial with 80 overweight, healthy~     volunteers. They will be randomly selected to drink one liter a day of one of the four drinks~     for six months. The objectives are changes in numerous circulating metabolic risk factors,~     changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and~     MR-spectroscopy).~      The investigators expect to clarify the mechanisms linking drinking habits to obesity~     development and provide scientifically based nutritional guidelines.~   "
212583|NCT00777634|"~     This study involves a 2.5 and 5 year follow-up interview for individuals who participated in~     the initial family study of binge eating disorder. The study includes individuals with and~     without eating disorder as well as their first degree relatives. As part of the study,~     participants will be interviewed about their current psychiatric and medical symptoms, their~     blood pressure will be measured, and laboratory specimens will be obtained.~   "
212584|NCT00777621|"~     Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in~     similar effects on blood glucose and insulin. The purpose of this study is to assess the~     hypothesis that weight loss through caloric restriction plus exercise will result in greater~     improvements on glucose tolerance and insulin action than similar weight losses through CR or~     EX alone.~   "
212585|NCT00777608|"~     This study will evaluate the performance of the CogState computerized neuropsychological~     battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's~     Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with~     mild-to-moderate Alzheimer's disease (AD).~   "
212586|NCT00777595|"~     The purpose of this study is to evaluate the effect of single doses of therapeutic and~     supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy~     subjects compared with placebo.~   "
212587|NCT00777582|"~     The purpose of this phase I randomised cross over study is to determine and compare the~     bioavailability of two different oral formulations of AZD2281 in advanced solid tumour cancer~     patients~   "
212588|NCT00777569|"~     In this study, smokers will be randomly assigned to one of three conditions for six weeks: 1)~     nicotine-free cigarettes (0.05mg); 2) extra low nicotine cigarettes (0.3 mg); or 3) medicinal~     4 mg nicotine lozenge. The tobacco toxin profiles across these various products will be~     compared. The effects of these products on biomarkers of exposure and risk factors for~     disease, compensatory smoking, components of tobacco addiction and short-term smoking~     cessation will be determined. Predictors of response to these products (e.g., compensatory~     smoking, compliance with product use, time to lapse) will also be examined.~      The following primary hypothesis will be tested: 1) Extent of tobacco toxin exposure will be~     greatest for the extra low nicotine cigarette and least for nicotine lozenge. Other secondary~     hypotheses include: 2) Compensatory smoking, as calculated by using cotinine, will be~     greatest for the extra low cigarette compared to the nicotine-free cigarette; 3) Greater~     positive subjective responses to cigarettes will be observed with extra low nicotine vs.~     nicotine-free cigarette; 4) Similar withdrawal symptoms and negative affect will be observed~     with nicotine-free cigarette and nicotine lozenge, and least withdrawal and negative affect~     with the extra low nicotine cigarette; 6) Least dependence and greatest motivation and~     self-efficacy to quit will be observed with nicotine lozenge and the greatest dependence and~     least motivation and self-efficacy to quit with the extra low nicotine cigarette use; 7)~     Shorter time to lapse will be observed with extra low nicotine vs. nicotine-free cigarettes~     because of extinction is likely to occur with nicotine-free cigarettes, and the longest time~     to lapse for nicotine lozenge because the cigarette condition groups will have experienced~     stronger attentional bias toward cues, and more dependence prior to the quit date and greater~     withdrawal after the quit date.~   "
212589|NCT00777556|"~     This is a non-comparative case series study to assess the ability of females 11-16 years of~     age, inclusive, who are requesting emergency contraception (EC) to use the study product,~     DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.~   "
212590|NCT00777543|"~     The aim of the present study is to investigate the effect of pretreatment of bran on~     improving the bioavailability of ferulic acid in wholegrain breads containing bran. As~     secondary endpoints we will investigate the changes in plasmatic antioxidant capacity,~     anti-inflammatory effects, colonic metabolites from ferulic acid and short chain fatty acids~     (SCFA).~   "
212591|NCT00777530|"~     The purpose of this study is to assess the safety and tolerability of ascending single oral~     doses of bosutinib administered with multiple doses of ketoconazole and to provide the~     pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole~     and with food in healthy adult subjects.~   "
212592|NCT00777517|"~     To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg~     commercial atorvastatin calcium tablet formulation.~   "
212593|NCT00777504|"~     The purpose of this study is to determine if and how often an unexpected fast increase of~     disease and complaints shows after stopping the anti-angiogenetic therapy~   "
212594|NCT00777491|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and gemcitabine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying two different chemotherapy and radiation~     therapy regimens to see how they work in treating patients with stage II or stage III bladder~     cancer that was removed by surgery.~   "
212595|NCT00777478|"~     The primary objective of this Phase 1 study is to identify the recommended dose of capiri and~     of sunitinib for combination therapy subsequent phase II trials.~   "
212596|NCT00777465|"~     The aim of this study was to apply the acute kidney injury criteria based on KDIGO~     classification in a population of patients undergoing cardiac surgery [coronary artery bypass~     grafting (CABG) or cardiac valve surgery (CVS)] and evaluate its impact as a predictor of~     30-day mortality.~   "
212597|NCT00777452|"~     to prospectively assess the health-related quality of life (HRQOL) changes during the first~     year after different treatment modalities for localized prostate cancer.~   "
212598|NCT00777439|"~     The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal~     disorders who have failed or suffered adverse effects from standard medical treatment.~   "
212599|NCT00777426|"~     A total of 60 participants will be enrolled. They will be in 3 groups~        1. ARV-naïve, HIV-positive ≥ 20 year of age with HAD (n=25) who intend to start ARV~        2. ARV-naïve, HIV-positive ≥ 20 year of age without HAD (n=25), who intend to start ARV~        3. HIV-negative ≥ 20 year of age (n=10). The protocol team will work with the primary care~          physician to ensure that the subjects receive standard HIV and ARV care; however,~          initiation of ARV is not a requirement of the study and ARV will not be provided by the~          study.~      Participant accrual will include 10-15 participants per year. HIV-positive subjects will be~     tentatively enrolled in HAD vs. non-HAD groups by the enrolling neurologist and subsequently~     confirmed to that group by a consensus conference held every 6 months by the study~     neurologists. In cases of disagreement, cases will be re-assigned to the consensus conference~     determination and recruitment will continue. An external validation consensus conference will~     be conducted as well every 6-12 months to monitor correct assignment of the level of~     impairment.~   "
212600|NCT00777413|"~     The purpose of this study was to determine the bioequivalence of Minocycline formulations~     after administration of single doses to normal healthy subjects under fed conditions. These~     data were to be evaluated statistically to determine if the products meet bioequivalence~     criteria.~   "
212601|NCT00777400|"~     The purpose of this pilot trial is to determine whether a conversion from calcineurin~     inhibitors (CNI) and mycophenolate mofetil (MMF) to a regimen consisting of efalizumab and~     sirolimus is associated with an increase in T regulatory cells, white cells that control the~     immune system and can prevent autoimmune diseases like arthritis or rejection of foreign~     organs,and does not result in an increase in acute rejection.~   "
212602|NCT00777387|"~     Preservation of fertility is limited. Current methods include embryo cryopreservation and~     while still experimental, ovarian cryopreservation. In single women who are at risk for~     infertility secondary to cancer or couples who have ethical reasons to avoid embryo~     cryopreservation, oocyte cryopreservation is an alternative Purpose of study is to compare~     slow freeze to vitrification of human oocytes. Successful cryopreservation and subsequent~     thawing programs are characterized by avoiding ice crystal formation.Vitrification, newer~     alternative to slow freeze method, process by which water is prevented from forming ice.~      Our hypothesis is that higher survival rate per oocyte is to be expected in the vitrification~     group.~   "
212617|NCT00777179|"~     This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study~     comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as~     maintenance treatment in patients with locally advanced or metastatic NSCLC, who have~     received and responded to prior platinum-doublet systemic chemotherapy. The primary objective~     of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally~     advanced or metastatic NSCLC patients with or without vandetanib maintenance.~   "
212603|NCT00777374|"~     Seasonal rhinoconjunctivitis or hay fever is a common atopic condition that is frequently~     seen in clinical practice. Grass pollen is the major cause of pollinosis in many parts of the~     world. Immunotherapy is the only treatment that may affect the natural course of allergic~     diseases, and it may also prevent the development of asthma in patients with allergic~     rhinitis. With conventional subcutaneous desensitization the duration of treatment is around~     3-5 years and usually comprises around 30-100 allergen injections. As high allergen doses~     have to be injected, allergic side effects may occur and patients must stay under medical~     supervision for at least 1 hour. Transcutaneous immunization (TCI) is a needle -free~     technique that delivers antigens and adjuvants to potent epicutaneous immune cells. The aim~     of the new epicutaneous route of desensitization is to more specifically target the immune~     system by loading Langerhans cells with the allergen. Lower antigen doses can be applied,~     such that side effects are reduced.~   "
212604|NCT00777361|"~     This study is being performed in order to learn more about a new drug (possible as treatment~     for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory~     and attention problems)) and how it is handled by the body by giving the drug to healthy~     volunteers with different genotypes.~   "
212605|NCT00777348|"~     This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study.~     At each study visit a standardised treadmill test will be performed to provoke EIA. Before~     and after the challenge test pulmonary function variables (e.g. forced expiratory volume in~     one second (FEV1)) will be measured in order to assess the protective effect of the study~     medication.~   "
212606|NCT00777335|"~     The purpose of the study is to assess the benefit of panobinostat monotherapy given either~     orally or i.v. to women with HER2-positive locally recurrent or metastatic breast cancer~   "
212607|NCT00777322|"~     The purpose of this study is to determine whether excimer laser corneal surface ablation~     (T−Cat) can be safely combined with simultaneous corneal collagen cross−linking treatment to~     produce an improved and stable corneal profile in the treatment of keratoconus.~   "
212608|NCT00777309|"~     This is a randomized, placebo-controlled, double blind phase 2 study designed to compare~     treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small~     cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen~     (other than erlotinib) for NSCLC.~   "
212609|NCT00777296|"~     A major factor in the respiratory health of CF subjects is acquisition of chronic Pseudomonas~     aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18~     years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation~     (Arikayce™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate~     encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and~     delivery to the lungs of subjects infected via a nebulizer. Because liposome particles are~     small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit~     drug in close proximity to the bacterial colonies (Meers, et al., 2008) (Clancy, et al.,~     2013), thus improving the bioavailability of amikacin at the infection site. The clinically~     achievable doses of amikacin in the LAI formulation can effectively increase the half-life of~     the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several~     advantages over current therapies in treating CF subjects with chronic infection caused by P.~     aeruginosa.~   "
212610|NCT00777270|"~     The best technique for this repair would be that which requires least time in realisation,~     least consumption of material for the repair and that which produces less pain at short and~     long-term permitting the resumption of intercourse quicker and with less pain thereby~     requiring less necessity to take out the stitches and less frequency of re stitching. The~     investigators research is looking for a technique for repairing the perineum more~     advantageously.~   "
212611|NCT00777257|"~     The purpose of this study was to evaluate the immunogenicity and safety of the concomitant~     administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.~      Primary Objective:~      To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces~     antibody responses that are similar to those observed when each vaccine is given separately.~      Secondary Objective:~      To compare the rates of injection site reactions at the Tdap injection site after Tdap and~     Menactra® vaccines are administered concomitantly to the corresponding rates of reactions~     when Tdap vaccine is administered alone.~   "
212612|NCT00777244|"~     Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of~     relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a~     retrospective multicenter international study showing that postoperative mitotane treatment~     was associated with a significant reduction of the risk of relapse and death. However, these~     promising results need confirmation in a randomized prospective study. Caution should be~     adopted particularly in patients with low risk of disease relapse, in whom the benefit of~     therapy should be weighted against the side effects. Even if an adjuvant treatment seems~     justified in patients at high risk of relapse, a randomised prospective study is needed to~     assess whether such a treatment is efficacious in patients at low-intermediate risk.~      The purpose of the present study is to determine whether adjuvant mitotane treatment is~     effective in prolonging the disease free survival in patients with adrenocortical carcinoma~     at low-intermediate risk of progression who underwent radical resection~   "
212613|NCT00777231|"~     The goal of this research study is to establish chimerism and avoid graft-versus-host disease~     in patients with Hemoglobinopathies to halt disease progression.~   "
212614|NCT00777218|"~     The purpose of this study is to determine if there are significant differences in the side~     effects related to memory, repetition and recall among these three drugs when used in a~     pediatric population.~   "
212615|NCT00777205|"~     We conducted a randomized controlled trial (RCT) that compared the effectiveness of a~     telephone delivered, recovery focused, peer-support intervention to enhanced usual care for~     VA patients with depression.~   "
212616|NCT00777192|"~     The goal of this research study is to learn more about the pain and/or other symptoms that~     patients may experience within five years from CRC diagnosis. Researchers also want to learn~     how genetic differences may affect the symptoms patients experience from cancer and cancer~     therapy.~   "
212629|NCT00777023|"~     Depomed's Gabapentin Extended Release is an investigational, extended release formulation of~     gabapentin that is being studied for the treatment of hot flashes in postmenopausal women~   "
212618|NCT00777166|"~     Oxytocin has cardio vascular effects as hypotension, tachycardia and possibly coronary spasm.~     The uterotonic effect of the drug is used during cesarean section, to minimize blood loss.ECG~     changes suggestive of cardiac ischemia (ST depression) has been showed in previous studies of~     patients undergoing cesarean section i regional anaesthesia. The effect of oxytocin on this~     outcome has not been investigated to any extent.~      In the current study, we tested the hypothesis that there was no difference in occurrence of~     ECG changes (ST segment depression) between two doses of oxytocin. Participants were~     randomized to receive either 5 or 10 units of oxytocin in a double blinded fashion.~      Main outcome measure is occurrence of significant ST depression on ECG. Secondary outcome~     measures are mean arterial pressure, heart rate, blood loss, symptoms as chest pain,~     shortness of breath and feeling of heaviness on the chest.~   "
212619|NCT00777153|"~     The purpose of this study is to see how effective cediranib is in treating a brain tumour~     called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an~     approved oral chemotherapy that belongs to the class of drugs called alkylating agents.~     Cediranib is a new drug that has not yet been approved for this disease. This study will~     compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo~     (inactive substance) to see whether the combination or cediranib alone will be more~     effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.~   "
212620|NCT00777140|"~     Iron overload has been associated with greater brain injury in ischemia/reperfusion~     experimental stroke models and ischemic stroke patients, especially in those treated with~     thrombolytic treatment. Deferoxamine administration, an iron chelator, offers a~     neuroprotective action in ischemia/reperfusion animal models.~      Primary objective: To evaluate the security and tolerability of deferoxamine endovenous~     treatment in acute ischemic stroke patients treated with iv. tPA.~      Secondary objectives: To study pharmacokinetics of deferoxamine given by endovenous bolus (10~     mg/Kg) followed by 72-hour continuous intravenous infusion (20, 40 o 60 mg/Kg). To evaluate~     the deferoxamine effect in clinical outcome, infarct volume and hemorrhagic transformation~     and brain edema development.~      Methodology: Double-blind, randomized, placebo controlled, dose-finding phase II clinical~     trial. Study stages: 1st: bolus+20 mg/Kg/day vs. Placebo (n=15:5); 2nd: bolus+40 mg/Kg/day~     vs. Placebo (n=15:5); 3rd: bolus+60 mg/Kg/day vs placebo (n=15:5). These doses will be~     increased according to security results of the previous stage. Patients will be continuously~     monitored in stroke units. Laboratory parameters will be measured at baseline, 24h, 72h and~     30 days to evaluate adverse events related to the drug. Serum deferoxamine and feroxamine~     concentrations will be measured along time after the injection in a subgroup of patients to~     the pharmacokinetics study. CT scan will be performed at 24-36h to assess hemorrhagic~     transformation and brain edema. The NIH Stroke Scale will be evaluated during~     hospitalization, and the Rankin score at discharge and 3 months.~      If deferoxamine demonstrate to be secure and well tolerated treatment in acute stroke~     patients, it may be a new therapy option to lower the brain injury after ischemia and~     reperfusion.~   "
212621|NCT00777127|"~     This clinical trial serves the purpose to compare the long-term effects of a treatment of~     actinic keratosis - your skin disorder - using Aldara® 5% cream or Solaraze® 3% gel on the~     face or the scalp. In particular, it should be found out whether the healing effect of these~     two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a~     prolonged period.~   "
212622|NCT00777114|"~     This will be a multi-center, Phase I, dose-escalation study of bortezomib in combination with~     131I-tositumomab in patients with relapsed non-Hodgkin's lymphoma. Bortezomib will be~     administered to patients twice weekly, with the first dose being given two days prior to the~     treatment dose of 131I-tositumomab, and the second dose two days after RIT for a total of 5~     doses.~      Patients will be enrolled and undergo standard staging studies, including history, physical~     examination, complete blood count, serum chemistries and LDH, TSH, HAMA, iliac crest bone~     marrow biopsy, and CT scans of the chest, abdomen and pelvis. All patients will provide~     written informed consent.~      Bortezomib will be evaluated at 4 dose levels (0.30 mg/m2, 0.60 mg/m2, 0.90 mg/m2, and 1.2~     mg/m2) and 131I-tositumomab at 2 dose levels (50 cGy and 75 cGy TBD). Bortezomib will be~     administrated the day prior to 131I-tositumomab and twice weekly thereafter for 4 doses in~     order to provide proteasome inhibition throughout the period of 131I-tositumomab activity.~     The intention is to use 131I-tositumomab at full dose if possible. Therefore, the 50cGy dose~     will be used only with the lowest dose of bortezomib in case of unexpected toxicities with~     the combination.~      Dose levels will be as follow:~        1. 0.30mg/m2 bortezomib and 50cGy 131I-tositumomab,~        2. 0.30 mg/m2 bortezomib and 75 cGy 131I-tositumomab,~        3. 0.60 mg/m2 bortezomib and 75 cGy 131I-tositumomab,~        4. 0.90 mg/m2 bortezomib and 75 cGy 131I-tositumomab, and~        5. 1.2 mg/m2 bortezomib and 75 cGy 131I-tositumomab.~   "
212623|NCT00777101|"~     This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib~     and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced~     breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and~     extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also~     compare the safety of the two regimens and to compare quality of life of patients taking the~     two regimens.~   "
212624|NCT00777088|"~     To determine the safety and effectiveness of Pipeline Embolization Device for the treatment~     of uncoilable or failed wide-necked intracranial aneurysms.~   "
212625|NCT00777075|"~     The purpose of the study is to determine whether the treatment with L-arginine leads to an~     improvement of erectile dysfunction in patients with erectile dysfunction.~   "
212626|NCT00777062|"~     To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension)~     for the treatment of co-occurring cocaine and alcohol dependence~   "
212627|NCT00777049|"~     The purpose of the study is to assess the benefit of oral panobinostat monotherapy given to~     women with HER2-negative locally recurrent or metastatic breast cancer.~   "
212628|NCT00777036|"~     The purpose of this study is to determine whether dasatinib is safe and effective in children~     and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+~     acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after~     imatinib or who are resistant or intolerant to imatinib. The side effects of this oral~     investigational drug in children and adolescents will be evaluated~   "
212630|NCT00777010|"~     Participants 60 and older with and without Parkinson's disease who have mild cognitive~     decline will be randomized to either a standard higher carbohydrate diet or a~     carbohydrate-restricted ketogenic diet for 8 weeks. The main hypothesis is that nutritional~     ketosis will improve memory functioning. Pre and post-memory testing will be performed.~     Subjects will also provide blood samples and a subset of subjects with receive magnetic~     resonance brain imaging.~   "
212631|NCT00776997|"~     The purpose of the study is to evaluate the safety and effectiveness of the LINX Reflux~     Management System in the treatment of Gastroesophageal Reflux Disease (GERD).~   "
212632|NCT00776984|"~     The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate~     the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to~     placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined~     as add-on controller therapy on top of usual care in patients with severe persistent asthma.~     The primary objective of each trial is to evaluate the long term efficacy of tiotropium over~     placebo on top of usual care in patients with severe persistent asthma as determined by~     pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on~     asthma control and health care resource utilisation. The secondary objective of each trial is~     to compare the long term safety of tiotropium with placebo in this patient population.~   "
212633|NCT00776971|"~     Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation~     leading to obesity development. Although drinks sweetened with aspartame are available the~     anticipated positive effect of these drinks on obesity development has not been convincing.~     However, the mechanisms linking drinks intake to obesity are yet to be clarified.~      The investigators aim is to investigate the short-term effects of soft drinks~     (sugar-sweetened and artificially sweetened (aspartame)), milk and water on the concentration~     of circulating appetite-regulating hormones, the subjective sensations of hunger and satiety~     (measured by visual analogue scales) and energy intake. The study is a crossover,~     intervention trial with 24 overweight, healthy volunteers. The subjects will be tested on~     four separate days for four hours. Each test day a preload drink (sugar-sweetened soft drink,~     aspartame-sweetened soft drink, semi-skimmed milk or water) is served.~      The investigators expect to clarify the mechanisms linking drinking habits to obesity~     development and provide scientifically based nutritional guidelines.~   "
212634|NCT00776958|"~     Goals of this registry:~      1.1 To collect and store very limited demographic information (age, birthdate, race and~     ethnicity), limited cancer risk and breast and ovarian disease history, as well as limited~     family history of breast and ovarian cancer on patients who are at risk of breast or ovarian~     cancer or who have had a diagnosis of either cancer,~      1.2 To make available summary information (in an anonymous form) regarding the subjects in~     this registry to Consortium members, and other investigators, who can use these data to plan~     research projects and evaluate the feasibility of such projects,~      1.3 To make available summary information (number of new patients seen in the clinic, number~     of mutations, number of preventive surgeries, average age of patients seen) to the Lynne~     Cohen Foundation for Ovarian Cancer Research, in order to document the numbers of subjects~     who utilize their supported clinics.~   "
212635|NCT00776945|"~     Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional~     (lymph node) recurrence. These recurrences may be difficult to detect in their earliest~     stages. We are attempting to use novel form of skin imaging that uses ultrasound combined~     with laser to identify these recurrences early, when they may be most amenable to treatment.~     This imaging will detect melanoma pigment below the surface of the skin and in the draining~     lymph nodes, as well as new blood vessel formation that occurs with these loco-regional~     metastases.~   "
212636|NCT00776932|"~     Specific Aims: 1) To examine differences between AA and white patients with knee OA in~     willingness to consider knee joint replacement. 2) To examine the relationship between~     socio-cultural factors and patient willingness to consider joint replacement. 3) To examine~     how demographic, socio-cultural, and clinical factors mediate the relationship between race~     and patient willingness. 4) To examine the relationship between patient willingness and~     referral to orthopedic care for knee OA (secondary aim).~      Experimental design/Methodology: A cross-sectional survey study design will be used to~     examine socio-cultural and clinical factors that may vary by race/ethnicity and may be~     determinants of willingness to consider joint replacement as a treatment option. Patients~     with symptomatic and radiographic knee OA from the primary care clinics will be surveyed.~     Only individuals with knee OA of sufficient severity that would be considered candidates for~     joint replacement will be included. Analytic strategies include ordinal logistic regression,~     path analysis, and regression trees.~      Subject population: The study sample will consist of approximately 133 African American and~     419 white patients with OA of the knee in a primary care setting.~   "
212637|NCT00776919|"~     This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a~     clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris~   "
212638|NCT00776906|"~     The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and~     effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the~     superficial femoral artery and popliteal artery.~   "
212639|NCT00776880|"~     American Society of Anesthesiologists (ASA) physical status scale has been used worldwide for~     assessing the status of patients before operation. However, merely the value of ASA scale did~     not give enough information of patients to determine their prognosis and improvement of~     outcomes. Since 1948, World Health Organization (WHO) defined health as the state of complete~     physical, mental and social well-being and not merely the absence of disease or infirmity.~     Therefore, the investigators hypothesized that the ASA scale only was needed to be modified~     and should be replaced by a comprehensive gauge to evaluate the status of patients in depth.~     Based on this thought, the investigators used a new system, i.e., physical-psycho-social~     (PPS) scale, to assess the overall state before surgical procedures.~   "
212640|NCT00776867|"~     The purpose of this study is to test whether perifosine- a drug that inhibits the protein~     AKT, and has had some success in the treatment of adult cancers- is safe and effective in~     treating cancer. The investigators want to find out what effects, good and/or bad, it has on~     the patient and the cancer. The investigators are testing different dose schedules of~     perifosine and the patient will be asked to partake in one of the dose schedules.~   "
212641|NCT00776854|"~     Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer~   "
212642|NCT00776841|"~     A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose~     Study of Aramchol in Healthy Male Volunteers.~      Primary Objectives:~        1. To assess and characterize the safety and tolerability of Aramchol in 16 healthy male~          subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight,~          mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses~          (Part B)~        2. To assess the pharmacokinetics of Aramchol at the administered doses~   "
212643|NCT00776828|"~     Objectives :~        -  To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel~          on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction,~          nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent~          implantation~      Study Design : Prospective, open label, two arm, randomized multicenter trial to test the~     superiority of cilostazol group compared with the control group. Patients will be randomized~     according to the use of cilostazol~      Patient Enrollment: 960 patients enrolled at 5 centers in Korea~      Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic~     follow-up will be recommended to all patient at 6 months after index procedure.~      Primary Endpoint~        -  Composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial~          infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months~      Secondary Endpoint~        -  All cause of death, stent thrombosis, and each component of primary endpoint at six~          months~        -  PRU level measured at discharge after the index procedure and after six months~      Safety Endpoint~        -  Bleeding complications according to TIMI criteria~        -  The incidence of drug discontinuation~        -  Heart rate~   "
212644|NCT00776802|"~     Phase 1/2, open-label, dose-escalation study to assess the safety and tolerability of GCS-100~     in combination with etoposide and dexamethasone in patients with relapsed or refractory~     diffuse large B-cell lymphoma.~   "
212645|NCT00776789|"~     Aims and Objectives~      Aim~      To determine the effect of delivery room Skin To Skin contact on breast feeding behavior of~     term neonates born by normal vaginal delivery at 36-48 hours.~      Objectives Primary objective To determine the effect of delivery room Skin To Skin contact on~     breast feeding behaviour of term neonates born by normal vaginal delivery, between 36-48~     hours (as measured by Infant Breast Feeding Score) by video recording using a randomized~     controlled design.~      Secondary objectives To determine the effect of delivery room Skin to Skin contact on~        1. Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA)~        2. Weight at 48 hours as measured by digital infant weighing scale.~        3. Maternal perception of breast milk output, breast consistency, infant's feeding and~          activity at 36-48 hours as measured by a score graded as very satisfied, satisfied,~          acceptable and not satisfied.~        4. Number and duration of feeding sessions till 48 hrs according to the mother as assessed~          at 48 hours~        5. Breast feeding rates at 6 weeks measured at the time of vaccination at the time of visit~          to the hospital for the same or as asked by telephonic conversation.~      Hypothesis~      Infants receiving skin to skin contact when compared with neonates not receiving it,~     demonstrate better breast feeding behaviour.~   "
212646|NCT00776776|"~     Very little information is available about extremely obese (body mass index [BMI] > 40 kg/m2)~     adolescents. The purpose of the Follow up of Adolescent Bariatric Surgery (FABS) study is to~     collect information obtained during the clinical care of obese adolescents from all over the~     country that can be used by researchers to study obesity, the complications of obesity, and~     the outcomes of obesity treatment during adolescence. This information will be used to~     describe the experience of the obese adolescent, including how obesity during adolescence and~     its treatment impacts health and well-being. The information may also be used to study causes~     of obesity, to determine the predictors of successful obesity treatment and for other obesity~     related research. Because of the importance of understanding the outcome of obesity and~     obesity treatments (surgical and non-surgical) on the patient over time, the data included in~     the study will be collected before, during and after any treatments rendered. For those who~     do not undergo a treatment which results in major weight change, it will be critical to~     determine the natural history of adolescent severe obesity as the adolescent transitions into~     adulthood. Finally, another important purpose of the FABS research study is to obtain~     patients' consent to be contacted for possible participation in future research studies.~      SPECIFIC AIMS:~        1. To describe the natural history of morbid obesity among adolescents who seek treatment~          for their obesity~        2. To describe major outcomes following bariatric surgery in adolescents evaluated at 3, 6,~          12, and annually for 10 years post-operatively and compare these to outcomes to patients~          managed non-surgically~        3. To organize a national cohort of severely obese adolescents who agree to be contacted in~          the future for research studies~   "
212647|NCT00776763|"~     Aims of the trial: Establishing the profile of the growth factors and other mediators of~     angiogenesis in different ocular fluids (aqueous humour, vitreous gel and ocular liquid in~     vitrectomized eyes), in the 2 most frequent proliferative retinopathies - diabetic~     proliferative retinopathy (PDR) and exudative age related macular degeneration (AMD).~     Following up the dynamic of this profile before and after intravitreal administration of~     Bevacizumab (Avastin) as an anti-VEGF blocker.~      Materials: The research will be conducted on the following categories of patients groups:~        -  nondiabetic patients without AMD or any other diagnosed proliferative ocular disease~          (controls)~        -  patients with age related macular degeneration (AMD groups) before and after~          intravitreal injections with Avastin~        -  diabetic patients with different types of diabetic retinopathy, before and after~          intravitreal Avastin (diabetic groups) Methods: Samples from different ocular fluids~          will be collected from each group of patients. 10 growth factors and other 10 cytokines~          will be determined in the ocular fluids samples.~      Results: The results from the biochemical measurements will be statistically interpreted in~     order to obtain conclusions for the clinical practice.~      Conclusions: The conclusions of this trial will be used exclusively for research publications~     and communications, as well as for clinical practice.~   "
212648|NCT00776750|"~     Disturbances of acquired immunity are considered to be responsible, at least partly, for the~     high infection rate and inadequate response to vaccinations observed in hemodialysis (HD)~     patients and renal transplant recipient (RTR). The present prospective trial aims at (a)~     evaluating the immunogenicity of a standard influenza vaccine in HD and RTR patients and (b)~     at identifying determinants of the immune response.~   "
212672|NCT00776438|"~     To further characterize the immune responses induced after an influenza vaccination performed~     either via the ID or the IM routes in two clearly distinct populations.~      Objectives:~        -  To describe the immune response per age group and vaccine group after vaccination.~        -  To describe the safety of the vaccines per age group and per vaccine group after~          vaccination.~   "
212689|NCT00776217|"~     To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating~     tablets of Ohm Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with~     Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc.,~     USA in healthy, adult, human male subjects under fasting condition.~   "
212649|NCT00776737|"~     This study will compare two tests for attention deficit disorder (ADD) - the Test of~     Variables of Attention (TOVA) and the NIH Test of Attention - to see if they produce the same~     results. There are a number of problems with existing tests for ADD. For example, TOVA, the~     most commonly used test, operates only on older computers and has other problems as well.~     Because of these problems, NIDCD developed the new NIH Test of Attention. This study will~     determine if the new test is valid for ADD and how the performance on this test compares to~     the performance on the TOVA in the general population.~      Healthy volunteers between 6 and 60 years of age who have no problems with sight or hearing~     and are not taking medication for ADD may be eligible for this study.~      After a brief interview, participants take the first of the two study tests. On a second~     visit, they take the other of the two tests. Both tests ask the subject to respond to things~     they hear and see on a computer screen. Each test takes 30 to 45 minutes to complete. Some~     participants are asked to take the NIH Test of Attention a second time, on a third visit.~     Participants also take a 15- to 20-minute subtest of the Weschler Intelligence Test.~   "
212650|NCT00776724|"~     This is a multi-center randomized phase III trial. The purpose is to evaluate and compare the~     pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored~     chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor~     size more than 2 cm.~   "
212651|NCT00776711|"~     Study Design:~      This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and~     immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One~     group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost,~     two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1~     boost but with different boost intervals, and one group will receive the DNA vaccine twice as~     prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human~     administration and will elicit antibody and T cell responses against the H5 protein. The~     primary objectives are to evaluate the safety and tolerability of the investigational vaccine~     regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in~     healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the~     study vaccine regimens.~      Product Description:~      The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade~     2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90~     microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID~     and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a~     CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be~     administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1~     vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System~     (Biojector) for the DNA vaccine.~      Subjects:~      A total of 60 healthy adults, ages 18-60 years will be enrolled.~      Study Plan:~      Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups.~     Subjects and clinicians will be blinded to group assignment until Day 0 following completion~     of the enrollment. At the point of enrollment the randomly assigned regimen will become known~     to subjects and clinicians. Subjects will receive either two or three injections on the~     schedule shown in the schema. The protocol requires five clinic visits and two telephone~     follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone~     follow-up contacts for Group 4.~   "
212652|NCT00776698|"~     This single arm study will evaluate the feasibility of treatment with 2 dose levels of~     Avastin in combination with concurrent thoracic radiation and chemotherapy in patients with~     locally advanced unresectable non-squamous non-small cell lung cancer. Two cohorts of~     patients will receive 3 cycles of Avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks,~     respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and~     etoposide). Once a preferred dose has been established, this dose will be applied to a 3rd~     cohort, who will then receive maintenance treatment with Avastin as a single agent for 6~     additional cycles. The anticipated time on study treatment is <3 months for cohorts 1 and 2,~     and 3-12 months for cohort 3, and the target sample size is <100 individuals.~   "
212653|NCT00776685|"~     Several personality factors have been shown to be associated with risk for alcohol and~     substance misuse, and differentiate substance abusers based on clinical profile, treatment~     response and susceptibility to other forms of mental illness. Personality-targeted~     interventions have been found to have significant preventative effects on onset and growth of~     drinking, binge-drinking and drinking problems in adolescents attending mainstream schools~     (Conrod, Castellanos & Mackie, 2008). The interventions concurrently reduced~     personality-specific emotional and behavioural problems (Castellanos & Conrod, 2006), and~     prevented the onset and escalation of drug-use over a two-year period (Conrod,~     Castellanos-Ryan & Strang, 2010). This cluster randomised controlled trial aims to examine~     whether these results can be replicated when interventions are delivered by trained~     educational professionals. In addition, the trial will evaluate the broader impact of the~     programme on cigarette smoking, school attendance, academic achievement and school-wide~     behaviours.~   "
212654|NCT00776672|"~     The objective of this study is to compare the relative bioavailability of fosinopril sodium~     40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in~     healthy adult subjects under non-fasting conditions.~   "
212655|NCT00776659|"~     To generate the following data from patients with early breast cancer treated with Aromasin®~     in the adjuvant setting in India.~        -  Efficacy of the treatment with Aromasin®~        -  Safety of the treatment with Aromasin®~   "
212656|NCT00776646|"~     To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm~     Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg~     tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting~     condition~   "
212657|NCT00776633|"~     The investigators hypothesize that reducing the duration of clopidogrel therapy from 6 months~     to 6 weeks after DES implantation is associated with improved clinical outcomes in patients~     on ASA and an oral anticoagulant.~   "
212658|NCT00776620|"~     The objective of this study is to compare the relative bioavailability of glimepiride 1 mg~     tablets (manufactured by Ranbaxy Laboratories Limited) with that of AMARYL® 1 mg tablets~     (following a single oral dose (1 x 1 mg tablet) in healthy, adult subjects under fed~     conditions.~   "
212673|NCT00776425|"~     This 2 arm study will investigate Quality of Life response in anemic participants with solid~     and lymphoid malignancies, who are receiving concomitant chemotherapy. Participants with~     solid and lymphoid malignancies will receive epoetin beta at a dose of 150 international~     units per kilogram (IU/kg) three times weekly. Participants with lymphoid malignancies will~     receive epoetin beta 30000 IU once weekly.~   "
212690|NCT00776204|"~     The objective of this study is to evaluate the completeness of struts coverage and vessel~     wall response to the new generation JACTAX drug-eluting stent vs Taxus stent in de novo~     coronary artery lesions at 6 months post index procedure. To investigate the completeness of~     the coverage as well as the number of uncovered stent struts per section, high resolution (~~     10-15 µm axial) intracoronary Optical Coherence Tomography (OCT) will be used.~   "
212659|NCT00776607|"~     Background: Latent autoimmune diabetes in adults [LADA] is a type 1 diabetes that is slowly~     developing. This means many people are treated as having type 2 diabetes at diagnosis as they~     are adults who are not immediately insulin dependent. LADA can be distinguished from type 2~     diabetes by antibody tests. Patients who are antibody positive have an autoimmune reaction~     which is similar to that of type 1 diabetes and is not found in type 2 diabetes. We would~     like to examine the best way of treating LADA in the early phase of the conditions, with~     tablets (similar to type 2 diabetes) or with insulin (similar to type 1 diabetes).~      Methods/Design: This is an open parallel group prospective randomised trial. Participants~     need to have a GAD antibody test results of 101 WHO units or more and a diagnosis of diabetes~     not requiring insulin at diagnosis. Participants will need to have been diagnosed within 12~     months and not treated with insulin at study entry. They will be randomised to receive either~     insulin (NovoMix 30) or tablets (diet treated followed by metformin followed by glitazone~     (with or without metformin) followed by insulin). Primary outcome assessment will be for~     change in HbA1c and change in fasting C-peptide over 24 months. Secondary outcome measures~     will include Quality of life, GAD antibody levels, adverse events, inflammatory markers,~     insulin resistance, and markers of the metabolic syndrome.~      Discussion: This study seeks the best treatment for early LADA in terms of maintaining~     glycaemic control and maintaining natural insulin production.~   "
212660|NCT00776594|"~     The purpose of this research study is to assess the efficacy of antiangiogenic therapy~     (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of~     minimal systemic disease (based on rising PSA without metastases).~   "
212661|NCT00776581|"~     Since 1999, labor pain control has being performed in China, and the initial time of~     analgesia is at the cervix >= 2 cm. Meanwhile, American Society of Obstetrics & Gynecology~     recommended that the labor analgesia with neuraxial block should be performed at the cervix~     >= 4 cm in 2002. After that, the threshold has been revised to at least >= 2 cm in 2006 by~     the Society. However, in China, the practice of labor analgesia with neuraxial block has~     being performed for over seven years. Up until now, the practice has being experienced during~     this ten-year period at the cervix around 1 cm. The investigators hypothesized that labor~     pain control in different stages had different characteristics and had different influence on~     patients short- and long-lasting outcomes. This study is mainly investigating different labor~     analgesia procedures in different stages since the initiation of the practice in 1999, and~     assessing their influence on the outcomes to display the trajectory of development of labor~     analgesia in China of which might fit to the the whole process of the study of labor~     analgesia throughout the world. All these were done by analyzing the data records since from~     January 1999 to December 2008.~   "
212662|NCT00776568|"~     The purpose of this study is to determine that extracorporeal shock wave therapy (ESWT) is~     safe and effective for the treatment of refractory angina pectoris.~   "
212663|NCT00776555|"~     The purpose of this study is to compare subjective drug liking using the Drug Rating~     Questionnaire, subject version (DRQ-S), question 2 and pharmacokinetics of Vyvanse™ and~     ADDERALL XR® when administered as an oral solution.~      Hypothesis: DRQ-S, question 2 will show no difference between the two drugs~   "
212664|NCT00776542|"~     The purpose of this study was to determine the bioequivalence of Minocycline formulations~     after administration of single doses to normal healthy subjects under fasted conditions.~     These data were to be evaluated statistically to determine if the products meet~     bioequivalence criteria.~   "
212665|NCT00776529|"~     AIM:~      Strengthening and sensorimotor training (e.g with the aim to improve balance) are widely used~     in rehabilitation. There is little knowledge about the best ways to combine strengthening and~     sensorimotor training. Therefore, the investigators want to evaluate two types of~     combinations in healthy participants.~      Interventions:~        -  Group A: 1.) warm-up; 2.) sensorimotor training; 3.) strength training (nine sessions in~          four weeks)~        -  Group B: 1.) warm-up; 2.) one strengthening exercise, followed by a sensorimotor~          exercise, alternating (nine sessions in four weeks)~      Tests (Before first training and after four weeks):~        -  isokinetic test of knee extensors and flexors (60°/s; 120°/s; 180°/s; 240°/s.)~        -  squat jumps and countermovement jumps~        -  static balance test on an unstable underground (measured with accelerometer)~        -  dynamic balance: star excursion balance test, (a) on stable ground, (b) on unstable~          ground. Balance tests will be performed (c) in recovered state and (d) fatigue (i.e.~          after a fatiguing exercise).~      Hypotheses~        1. Group B (alternating sensorimotor and strength exercises) will improve more in the~          balance tests than Group A (sensorimotor first, strength afterwards).~        2. Group B will improve more in the countermovement jump than Group A.~        3. There will be no differences in the improvements in the strength, power and squat jump~          tests between the two groups.~   "
212666|NCT00776516|"~     The objective of the study is to assess the PK, safety and tolerability of a single dose of~     mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.~   "
212667|NCT00776503|"~     The purpose of this study is to determine the maximum tolerated duration and schedule of oral~     VORINOSTAT in addition to low dose cytarabine in the treatment of Intermediate-2 and High~     risk myelodysplastic syndromes.~   "
212668|NCT00776490|"~     The objective of this study is to compare the relative bioavailability of glimepiride 1 mg~     tablets (manufactured by Ranbaxy Laboratories Limited) with that of AMARYL® 1 mg tablets~     following a single oral dose (1 x 1 mg tablet) in healthy, adult subjects under fasting~     conditions.~   "
212669|NCT00776477|"~     Clopidogrel is a antiplatelet agent and is effective at reducing intimal hyperplasia in~     animal models of thrombosis.Several large clinical trials have demonstrated that clopidogrel~     with aspirin can reduce ischemic events and mortality in patients with atherosclerotic~     disease,therefore the combination of two antiplatelets might be useful to prevent patients~     received coronary artery bypass graft surgery from Saphenous vein graft disease. the aim of~     this study is to estimate the safety and efficacy of clopidogrel and aspirin therapy versus~     aspirin alone in patients after CABG.~   "
212670|NCT00776464|"~     A study to treat 4 toes at a time to eliminate Onychomycosis~   "
212671|NCT00776451|"~     To demonstrate the ability of intermediate AMD subjects to follow the instructions for use~     and properly operate on their own the Preview PHP in home use environment, after going~     through training session.~   "
212674|NCT00776412|"~     This study will collect information about markers of inflammation, blood clotting and blood~     vessel function in HIV-infected adults and healthy volunteers. Biomarkers are biological~     indicators that have been associated with disease. Certain markers of inflammation, blood~     clotting, and blood vessel function have been associated with risk of cardiovascular disease,~     stroke and death. One marker, called D-dimer, is a breakdown product of blood clots that has~     been associated with serious medical conditions, including deep vein thrombosis (formation of~     a blood clot in a vein deep in the body) and pulmonary embolism (blockage in the pulmonary~     artery that occurs when a blood clot from a vein breaks away, travels to the pulmonary artery~     and lodges there). High D-dimer levels have also been associated with cardiovascular disease~     and stroke risk. In a recent study of HIV-infected patients, higher D-dimer levels were~     strongly correlated with risk of death from any cause. The significance of changes in D-dimer~     and other biomarkers in HIV-infected adults is not well understood. This study will further~     explore D-dimer and other biomarkers to try to better understand the relationships between~     them and HIV infection.~      Healthy volunteers and HIV-infected adults 18 years of age or older may be eligible for this~     study. Two visits are involved, as follows:~      Visit 1 (screening visit to determine eligibility)~        -  Medical history and physical examination.~        -  Blood tests for HIV infection, blood counts, liver and kidney function.~        -  Pregnancy test for women who can become pregnant.~      Visit 2~        -  Blood tests for hepatitis B and C~        -  Blood tests for markers of inflammation and blood clotting.~        -  Blood test for genetic changes that influence blood clotting.~      In some cases, visits 1 and 2 may be combined.~      Optional additional visits (up to 8 visits over 3 years)~        -  Additional blood draws for investigation of specific clinical or laboratory findings may~          be requested.~   "
212675|NCT00776399|"~     Lung metastasectomy is the only therapeutic option to provide a long-survival in patients~     with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation~     is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In~     this phase-II trial, clinical utility of lung RF ablation will be evaluated in patients with~     resectable colorectal lung metastases.~   "
212676|NCT00776386|"~     This study has two purposes. First, the investigators will identify determinants of changes~     in motor ability, activities of daily living, and HRQOL after distributed Constraint-induced~     therapy for patients with stroke with the Chi-squared Automatic Interaction Detector (CHAID)~     analysis. The results will help target which types/characteristics of patients will benefit~     most from the intervention and may identify different determinants across different levels of~     outcomes. Secondly, in order to understand the extent of treatment effect in terms of~     clinical relevance, the investigators will examine whether the change scores on measures of~     motor ability, activities of daily living, and HRQOL after distributed CIT reach clinically~     important differences or not.~   "
212677|NCT00776373|"~     Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in~     relapsed and refractory patients with aggressive lymphoid malignancies.~   "
212678|NCT00776360|"~     The investigators are going to examine whether oxytocin has a prokinetic effect on gastric~     emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with~     sodium chloride infusion.~   "
212679|NCT00776347|"~     The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil~     therapy and to associate change of glucose metabolism and symptoms.~   "
212680|NCT00776334|"~     The objective of this study is to compare the relative bioavailability of fosinopril sodium~     40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in~     healthy adult subjects under fasting conditions.~   "
212681|NCT00776321|"~     Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in~     the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has~     in a clinical 2-weeks studies demonstrated pronounced reduction of independent risk factors~     for the development of atherosclerotic cardiovascular diseases.~      The purpose of the study is to assess the efficacy and safety of KB2115 as monotherapy~     following 12 weeks of exposure compared to placebo. The aim of the study is to assess~     efficacy (LDL-cholesterol lowering effects) and safety of KB2115.~   "
212682|NCT00776308|"~     Conventional mammography is not a reliable method for determining the extent of disease in~     women with breast cancer. Molecular Breast Imaging (MBI) is a new nuclear medicine technique~     that allows the breast to be imaged in a manner similar to mammography, but without the pain~     of compression. Initial results with this method have shown it is very good at detecting~     small breast cancers (~1/4 inch).~      The purpose of this study is to see if MBI is a better method than mammography in determining~     how much cancer is present before a woman goes to surgery.~      The study will comprise 120 women with breast cancer who are going to surgery. The~     investigators hope that this study will demonstrate that MBI will be more accurate in~     determining how much cancer is present.~   "
212683|NCT00776295|"~     The purpose of this study is to determine whether p53 vaccination followed by high dose~     chemotherapy and autologous HCT and T cell therapy significantly induces immune responses~     resulting in 1-year survival greater that the current 70%.~   "
212684|NCT00776282|"~     To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating~     tablets of Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, Inc. USA) with~     Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc.,~     USA in healthy, adult, human male subjects under fed condition.~   "
212685|NCT00776269|"~     In this clinical trial study,the investigators intend to compare two methods of trichiasis~     treatment.One by argon laser and the other by radiofrequency then compare the result of these~     procedures, especially, the investigators would like to compare which of these have less~     complications such as bleeding,pain,notch in the site of surgery and etc.~   "
212686|NCT00776256|"~     The effect of beta-glucan or fructo-oligosaccharide or their combination in bars on satiety~     and food intake was tested by supplying these bars on two consecutive days.~   "
212687|NCT00776243|"~     In type 2 diabetic patients, abnormality in secretion or action of incretin(GLP-1, GIP) is~     observed. Although controversy still exists, the secretion of GLP-1 is thought to be reduced~     by 20-30% while GIP secretion is normal or slightly elevated, in type 2 diabetic patients.~     Various parameters such as the duration of diabetes, the amount of meal and their~     constitution, gastric bypass surgery, and some antidiabetic drugs affect the secretion of~     incretin. However, the secretion of GLP-1 and GIP in glucotoxic condition and whether they~     recover after improvement of glycemic status is not known. The investigators aim to study the~     effect of intensive insulin treatment in uncontrolled diabetic patients.~   "
212688|NCT00776230|"~     The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time~     points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV~     neutralizing antibodies at Day 56 after the first vaccination.~   "
213653|NCT00763347|"~     The purpose of this study is to determine the efficacy and safety of SYR-619, once daily~     (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with~     diet and exercise, or by taking metformin.~   "
212691|NCT00776191|"~     The purpose of this study is to demonstrate an increase in protein metabolism during~     treatment with Physioneal 35® (containing lactate 10 mmol/l, calcium 1.75 mmol/l) compared to~     treatment with Physioneal 40® (containing lactate 15 mmol/l, calcium 1.25 mmol/l) in children~     and adolescents with end stage renal failure receiving peritoneal dialysis.~   "
212692|NCT00776178|"~     Background:~        -  Bladder cancer often recurs after treatment and patient survival varies greatly.~        -  More knowledge is needed about factors that can help identify patients who are at~          greater risk of disease recurrence and progression to minimize the need for screening~          and to help guide treatment.~        -  The New England Study of Environment and Health (NESEH), conducted by the departments of~          health in Maine, New Hampshire and Vermont, the Dartmouth Medical School and the NIH,~          examined the relationship between health and environmental factors such as smoking, diet~          and water quality in New England. This study provides an opportunity to learn more about~          patients with bladder cancer.~        -  Before launching a full-scale follow-up study on bladder cancer, it is necessary to~          determine the feasibility of obtaining needed follow-up information from patients~          enrolled in the NESEH.~      Objectives:~      -To determine the completeness and quality of information about treatment, recurrence, and~     progression that can be obtained for patients from their medical records.~      Eligibility:~      -Participants from the NESEH study who are residents of Maine and who were diagnosed with~     bladder cancer between 2001 and 2003.~      Design:~        -  Determine the vital status of NESEH bladder cancer patients.~        -  Select a sample of 40 living and 18 deceased patients.~        -  Interview patients or their next of kin by telephone for about 30 to 45 minutes to~          update exposure information, obtain names and addresses of all hospitals and physicians~          they have seen since diagnosis, and obtain authorization to access medical records.~        -  Obtain and abstract medical records.~   "
212693|NCT00776165|"~     A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The~     Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor~     (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.~      Adult patients (18 years of age or older) diagnosed as having any malignancy (except myeloid~     malignancy, ECOG status of 0-2 and having a history of experiencing neutropenia (absolute~     neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of~     chemotherapy on the same drugs would be recruited into the study.~      Treatment will be initiated not earlier than 24 hours after the administration of cytotoxic~     chemotherapy in both groups.~      Group 1: Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha)~        -  Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion~          for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of~          10,000/mm3 is reached whichever is earlier Group 2: Neupogen (rhG-CSF)~        -  Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion~          for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of~          10,000/mm3 is reached whichever is earlier Primary End Point would be to evaluate the~          percentage of patients developing febrile neutropenia (defined as body temperature ≥~          38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute~          neutrophil count < 0.5 x 109/L on the same day of the fever or the day after)in the two~          treatment groups.~   "
212694|NCT00776139|"~     An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover~     bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories~     Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of~     Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fasting~     condition~   "
212695|NCT00776126|"~     Mammography remains the current standard in the detection of breast cancer. However,~     conventional two-view mammography will not detect all cancers. The major limiting factor of~     conventional mammography is the presence of superimposed breast tissue that can obscure~     clinically significant lesions. It is this limitation that decreases the sensitivity of~     mammography and leads to false negative results.~      The recent development of digital detectors has allowed imaging technologies such as~     tomosynthesis to become clinically feasible. The examination, similar to conventional~     mammography with regard to patient positioning and glandular dose, allows acquisition of a~     digital data set that can be reconstructed and viewed in multiple sections. The ability of~     tomosynthesis to unmask overlapping structures has been shown in preliminary studies to~     increase lesion visibility. Used as either a primary imaging modality, or as an adjunct to~     screening mammography, tomosynthesis has the potential to provide increased sensitivity and a~     lower number of false negative examinations.~      The purpose of this study is to compare radiologist impression of digital breast~     tomosynthesis to digital mammography with respect to their ability to see and characterize~     specific lesion features.~   "
212696|NCT00776113|"~     The objective of this study was to compare the single-dose oral bioavailability of Carvedilol~     12.5 mg tablets of Ohm Laboratories with Coreg 12.5 mg tablets in healthy, adult, human~     subjects under fasting conditions.~   "
212697|NCT00776100|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Sometimes, after~     chemotherapy, the tumor may not need more treatment until it progresses. In this case,~     observation may be sufficient. It is not yet known whether radiation therapy is more~     effective than observation after chemotherapy in treating non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying how well radiation therapy works compared~     with observation after chemotherapy in treating patients with stage IV non-small cell lung~     cancer.~   "
212698|NCT00776087|"~     BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their ICD~     and CRT-D patients in a remote fashion, with fewer in-clinic consultations. This may result~     in a more efficient FU and cost-savings for the health care payer.~      The EuroEco study:~        1. Outlines a new HM-based FU model for the ICD and CRT-D patients that combines in-clinic~          consultations and regular check ups of the patient/ICD/CRT-D data received through the~          HM service.~        2. Compares the direct costs for physicians and clinics for the HM-based FU of ICD and~          CRT-D patients versus the traditional FU.~        3. Compares the indicators of patients' safety between the two FU models.~   "
212699|NCT00776074|"~     The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free~     formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with~     uterine fibroids.~   "
212701|NCT00776035|"~     Sex has a major impact on myocardial metabolism and blood flow. In subjects without heart~     failure men's hearts tend to use proportionally more glucose and women's hearts use more fat~     and have higher blood flow.~      Obesity is a major risk factor for Heart Failure. In subjects without heart failure,~     increasing body mass index is predictive of increased blood flow and fatty acid metabolism in~     women, but not men.~      To measure blood flow and metabolism we will be using radioactive materials and a PET~     (positron emission Tomography)scan to study the metabolism of the heart.~      Hypotheses: 1) Women with nonischemic heart failure will have higher levels of heart blood~     flow and fatty acid metabolism and lower glucose metabolism rates than men with nonischemic~     heart failure 2) Patients with obesity-related HF have a myocardial metabolic profile that is~     similar to that of obese subjects without heart failure and different (higher FA metabolism)~     from that of nonobese Heart failure patients.~   "
212702|NCT00776022|"~     An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover~     bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories~     Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of~     Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fed condition~   "
212703|NCT00776009|"~     This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30~     mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity~     Disorder (ADHD) in a 12-hour laboratory classroom setting.~   "
212704|NCT00775996|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Ranbaxy and Abbott (TranxeneeT-Tab®) 15 mg clorazepate dipotassium tablets under fasting~     conditions.~   "
212705|NCT00775983|"~     This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day~     Dilapan for cervical preparation for surgical abortions occurring between fourteen and~     eighteen weeks gestation. Comparisons will be made between procedure time, need for~     additional dilation, occurrence of complications, and patient and provider satisfaction.~      Hypothesis:~      Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation,~     with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within~     a five-minute difference.~      Primary objective:~      Determine differences in procedure times~      Secondary objectives:~      Examine complications, and need for additional dilation between early second-trimester~     surgical abortions performed after cervical preparation with same-day Dilapan versus those~     performed after cervical preparation with overnight laminaria~   "
212706|NCT00775970|"~     The purpose of this study is to determine whether walking exercise after dietary treatment of~     obesity is associated with a decrease of the daily spontaneous physical activity and\or with~     an increase of the time spent in sedentary activities. Our hypothesis is that the practice of~     walking as an exercise during the phase of weight stability following the dietary treatment~     of obesity leads to a reduction of spontaneous physical activity and\or to an increase in the~     time spent in sedentary activities.~   "
212707|NCT00775957|"~     A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the~     initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the gold standard~     FDG-PET.~   "
212708|NCT00775944|"~     This study shall determine whether or not proactive telephone support for smoking cessation~     delivered to quitline callers is more effective than standard 'reactive' provision and~     whether or not the offer of a voucher for a cost free supply of nicotine replacement therapy~     (NRT) has any additional impact on smoking cessation rates achieved by behavioural~     interventions.~   "
212709|NCT00775931|"~     The purpose of this research is to explore what we believe may be a safer and more effective~     means of performing stem cell transplantation in patients with Osteopetrosis, using~     chemotherapy and radiation designed to bring about engraftment and lessen transplant~     mortality. Prior multi-institutional data in past studies found that approximately 30% of~     Osteopetrosis patients do not engraft. Therefore, in this study, we utilize a reduced~     intensity design of pre-transplant drugs to try to make transplants safer for this disease,~     as well as to provide a second infusion of stem cells in patients with matched related or~     unrelated donors.~   "
212710|NCT00775918|"~     The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate~     formulations after administration of single doses to normal healthy subjects under fed~     conditions. These data were to be evaluated statistically to determine if the products meet~     bioequivalence criteria.~   "
212711|NCT00775905|"~     The objective of this study was to compare the rate and extent of absorption of Ranbaxy~     amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one4ablet dose in~     fasted subjects.~   "
212712|NCT00775892|"~     A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety~     and performance during total anterior cruciate ligament (ACL) reconstruction.~   "
212713|NCT00775879|"~     Sevoflurane is widely used for induction of anaesthesia. Several studies showed EEG~     abnormalities during mask induction with sevoflurane. The aim of our study was to test the~     induction target concentration of sevoflurane on the spikes wave occurrence.~   "
212714|NCT00775866|"~     In this study we will test a new procedure to guide needle biopsies into the prostate gland~     based on MRI. This study will be conducted in patients who may have recurrence of their~     cancer in the prostate gland after radiation therapy in order to map out the location of the~     recurrence. Using this technique, we will be able to measure the accuracy of MR images in~     identifying the site of tumour recurrence.~   "
212731|NCT00775645|"~     RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is~     not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing~     neuropathy caused by chemotherapy.~      PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how well it~     works compared with a placebo in preventing neuropathy in women with stage I, stage II, or~     stage III breast cancer undergoing chemotherapy.~   "
212742|NCT00775502|"~     This study will test the ability of a specially designed monoclonal antibody to destroy~     multiple myeloma cells. This antibody is unique in its ability to promote the death of~     multiple myeloma cells by processes known as antibody dependent cellular cytotoxicity~     (ADCC)and complement dependent cytotoxicity (CDC). The study is designed to determine both~     the optimal dose of the antibody to destroy multiple myeloma cells and frequency of dosing.~   "
212715|NCT00775853|"~     This study (https://pdrisk.ninds.nih.gov) will determine if people who have risk factors for~     Parkinson disease (PD) have biomarkers (objective ways to measure a disease process) that~     show that the disease process is actually going on, and if people who have abnormal~     biomarkers go on to develop PD during several years of follow-up. Biomarkers of Parkinson~     disease (PD) might identify people who are healthy now but may develop the disease later in~     life.~      Healthy volunteers and people who have certain risk factors for developing PD who are between~     18 and 70 years of age may be eligible for this study. People with the following risk factors~     are included:~        -  Family history of PD~        -  Loss of sense of smell~        -  Fall in blood pressure when standing up~        -  REM behavior disorder (a type of sleep disturbance)~      Participants undergo the following tests and procedures:~        -  Screening examination~        -  Medical and neurological history and physical examination~        -  Tests or rating scales for movement, sense of smell, mood, attention, fatigue, pain, and~          thinking.~        -  Measurement of blood pressure and pulse rate while lying down and then standing up~        -  Blood draw for genetic testing~        -  Inpatient testing at the NIH Clinical Center for 2-3 days, including:~        -  Measurements while blowing against a resistance~        -  Measurements of blood pressure and pulse rate~        -  Blood draws for levels of various chemicals~        -  PET and MRI scanning~        -  Lumbar puncture (spinal tap)~        -  Electrocardiogram~        -  Skin electrical conduction test (test of sweat production)~        -  Skin and core temperature measurements~        -  Transcranial ultrasound (sound-wave test of the head)~        -  Follow-up testing (up to five visits in 18-month intervals) to repeat some of the tests~          listed above, excluding the genetic testing and spinal tap~   "
212716|NCT00775840|"~     The purpose of this study is to determine the effects of candesartan, once daily (QD), on the~     N-terminal pro-B-type Natriuretic Peptide laboratory marker in subjects with symptomatic~     heart failure with diastolic dysfunction.~   "
212717|NCT00775827|"~     The study was conducted as an open label, balanced, randomised, two-treatment, two-period,~     two-sequence, single-dose crossover bioavailability study on fenofibrate formulations~     comparing fenofibrate 160 mg tablets of Ranbaxy Laboratories with Tricor 160 mg tablets in~     healthy, adult, human subjects under fasting conditions.~   "
212718|NCT00775814|"~     The purpose of this study is to determine the efficacy of candesartan, once daily (QD),~     combined with hydrochlorothiazide to lower blood pressure in insulin-resistant, obese~     patients with hypertension.~   "
212719|NCT00775801|"~     This study will look at the result of using the FLD device as an artificial lumbar disc. The~     study will compare the safety and effectiveness of the FLD artificial lumbar disc to an~     already approved artificial lumbar disc.~   "
212720|NCT00775788|"~     Structural fat grafting is a form of tissue transfer where the autologous fat is harvested~     and subsequently transferred to a different region of the body at the same setting. It is an~     excellent technique for filling soft tissue and contour defects. Fat has the benefit of being~     abundantly available and easy to harvest. Further more, it is cheap and autogenous and thus~     lacks the side effects of synthetic fillers or implants. Autogenous fat transfer is a~     relatively common procedure performed by plastic and reconstructive surgeons. The goal of fat~     grafting is to provide the patient with a predictable, long lasting autogenous soft tissue~     augmentation. Autogenous fat transfer has been used extensively as an adjunct to facial~     rejuvenation. As well it has been applied to body contouring and augmentation of the hips,~     trochanteric areas, thighs and buttocks, back, torso and breast. The transfer of autologous~     fat dates back to 1890s and more specifically as injectable grafts since the 1920s. However,~     over the past 20 years the popularity of structural fat grafting has increased as a~     contouring modality. Fat transfer to the breast, popularized by Coleman, has been performed~     internationally since the 1990s. Despite the duration, the literature lacks accurate outcomes~     data on fat transfer to the breast and questions regarding the viability of adipocytes after~     the transfer exist. Sources from various publications show cell viability of up to 100%~     however studies of long term clinical outcomes quote rates of 10% to 80%.~   "
212721|NCT00775775|"~     This study will test if patients with moderate to severe traumatic brain injuries also have~     endocrine abnormalities, examine any existing relationships among fatigue, depression and~     endocrine abnormalities, and the relationship between endocrine abnormalities, quality of~     life, and community integration.~   "
212722|NCT00775762|"~     This is a monocentric, randomized, opened study to assess the anti-inflammatory and~     anti-platelet effect of Clopidogrel and aspirin versus aspirin or clopidogrel alone in~     patients with symptomatic polyvascular disease and with multiple recurrent cardiovascular~     events.~   "
212723|NCT00775749|"~     The purpose of this study is to see if the nicotine patch reduces post operative nausea~     and/or vomiting (PONV) among non-smoking patients who are at high risk of PONV.~   "
212724|NCT00775736|"~     This study is conducted in Europe. The objective of this observational study is to evaluate~     the number of serious side effects, when initiating NovoMix® treatment in patients with type~     2 diabetes who previously used a human premix insulin under normal clinical practice~   "
212725|NCT00775723|"~     Objective: Melatonin production is known to be delayed in preterm-born infants up to 6 months~     of age. This might be related to exposure of preterm infants to continuous lighting in the~     NICU during a critical period of pineal gland development. The investigators aimed to test~     the profile of melatonin production in these infants at 9-12 months of age.~      Methods: Twenty three term-born and 23 preterm-born infants (gestational age: 29-34 weeks)~     were studied. The investigators tested nocturnal urinary melatonin excretion, within a~     repeated measures design, both at 9 and 12 months of age. Nocturnal urine was extracted from~     diapers and urinary melatonin derivate (6-sulphatoxymelatonin) excretion was analyzed by~     ELISA assay.~   "
212726|NCT00775710|"~     The purpose of the study is to determine the optimal method to withdraw non-invasive~     ventilation after an episode of hypercapnic respiratory failure.~   "
212727|NCT00775697|"~     In this study children with recurrent wheezing (>/= 2 episodes in the last 6 months)and aged~     less than 2 years will be enrolled as outpatients. They will undergo lung function evaluation~     by Rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with~     Montelukast 4 mg/day. Symptom dairies will be filled by parents during the study period.~   "
212728|NCT00775684|"~     This study evaluates exenatide, sitagliptin, and glimepiride for the treatment of high blood~     sugar in patients with impaired fasting glucose or early type 2 diabetes. The purpose of this~     study is to determine if exenatide and sitagliptin increase the amount of insulin made by the~     pancreas compared to glimepiride. It is hypothesized that exenatide or sitagliptin will~     sustain or increase the amount of insulin made by the pancreas in comparison to glimepiride.~   "
212729|NCT00775671|"~     Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin~     sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.~   "
212730|NCT00775658|"~     Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test~     reactivity.~   "
212732|NCT00775632|"~     Graft versus host disease (GVHD) is one of the common complications after stem cell~     transplant. This is a complication, which happens when the new stem cells from the donor~     attack other cells in the body of the transplant recipient.~      Recently, an antibody (protein) called alemtuzumab or Campath has been found to be effective~     in the prevention of Graft vs. Host Disease.~      Previous studies have shown a low risk of GVHD with alemtuzumab, however the risk of disease~     recurrence was high. Previous studies have used a high dose of alemtuzumab. The purpose of~     this study is:~        -  To find if by lowering the dose of alemtuzumab, can serious GVHD be prevented without~          increasing the risk of relapse (your condition getting worse).~        -  To find whether low dose of alemtuzumab in combination with cyclosporine can prevent~          GVHD more effectively when compared to current standard of care and does not increase~          the risk of recurrence.~   "
212733|NCT00775619|"~     The objective of this study was to compare the single-dose oral bioavailability of Carvedilol~     12.5 mg tablets of Ranbaxy Laboratories with Coreg 12.5 mg tablets of Glaxosmithkline in~     healthy, adult, human subjects under fed conditions.~   "
212734|NCT00775606|"~     The ideal anti-HIV medications for patients with advanced HIV disease is unknown. There is~     evidence that anti-HIV regimens that contain protease inhibitors can enhance immune function~     better than regimens that do not contain protease inhibitors. This is a study that will~     determine the difference in immune enhancement capabilities between an anti-HIV regimen that~     contains the protease inhibitor - lopinavir-ritonavir, and a regimen that contains efavirenz.~     Both medications are recommended as first line treatments for HIV-infected patients. This~     study will recruit HIV-positive patients that need to start anti-HIV treatment because their~     CD4+ T-cells are below 200. The usual threshold for starting treatment is a CD4+ T-cell less~     than 350. Subjects will be randomized to treatment with either an anti-HIV regimen that~     contains lopinavir-ritonavir or a regimen that contains efavirenz. The study will determine~     the difference in immune reconstitution over 24 weeks of treatment with study medications.~     Among the immune parameters that will be measured is the ability of each subject to respond~     to vaccination with the tetanus-diphtheria vaccine and the 23-valent pneumococcal vaccine.~     Both vaccines are also recommended for HIV-positive patients but HIV-positive patients tend~     to have a lower response rate to these vaccines.~   "
212735|NCT00775593|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving clofarabine together with~     temsirolimus works in treating older patients with relapsed or refractory acute myeloid~     leukemia.~   "
212736|NCT00775580|"~     The purpose of this study was to determine the bioequivalence of atenolol formulations after~     administration of single doses to normal healthy subjects under fasted conditions. These data~     were to be evaluated statistically to determine if the products meet bioequivalence criteria.~   "
212737|NCT00775567|"~     Fructose is the principal carbohydrate in fruits and is added to many food products. This 6~     carbon sugar is associated with a number of ill effects, like promotion of high~     triglycerides,precipitation of gout in men,possible depression in women and symptoms of~     intolerance in a non ethnic dose dependent fashion.However, high fruit and vegetable intake~     is associated with some epidemiologic evidence in prevention of some cancers like stomach and~     colorectum.The principal protectors in these products are thought to be antioxidants and~     other protective chemicals like polyphenols.In addition long chain polymers of~     fructose:inulin are thought to help protect against cancer through prebiotic effects. In fact~     poly-fructose molecules are used as prebiotic food supplements and are promoted as aids for a~     healthy intestine with balanced microflora.~      Polyfructose prebiotics induce some gastrointestinal symptoms of cramps gas bloating and~     sometimes diarrhea.To date repeated consumption of these polyfructose molecules have not been~     shown to induce colonic adaptation. Nor is there evidence that fructose intolerant people~     adapt  to prolonged ingestion.~      These findings are in contrast to findings with lactose intolerance where prolonged ingestion~     leads to both symptomatic and physiological adaptation.In this interventional study we~     evaluate whether fructose intolerant people can adapt to moderate dose daily fructose~     ingestion.The desired outcome is symptomatic, physiological and colonic microfloral~     adaptation. A failure to detect an increase in bifidobacteria on retesting may suggest that~     in humans like in some other mammals GLUT5 fructose transport could be induced.~   "
212738|NCT00775554|"~     Will use visual analog scales to compare effectiveness of traditional hematoma block vs~     ultrasound guided hematoma block with regards to pain. This will be done for closed forearm~     fractures.~   "
212739|NCT00775541|"~     The purpose of this study is to use an MRI exam to measure the concentrations of glutathione~     (GSH) and Vitamin C (Asc) in the brains of normal healthy persons and type 2 diabetic~     persons. The study will look at the relationship between chronic hyperglycemia and the levels~     of these naturally occurring chemicals in the brain.~   "
212740|NCT00775528|"~     This study will assess the safety and tolerability of pancrelipase delayed release capsules~     in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic~     Fibrosis.~   "
212741|NCT00775515|"~     Prostatitis is an inflammation of the prostate, an pelvic organ of men. Prostatitis can cause~     great discomfort which varies but can include pelvic pain, pelvic pressure, a vague sense of~     discomfort, a feeling of malaise and fatigue, fever, burning on urination, pain on reaching~     orgasm, and bleeding.~      In many men the symptoms of prostatitis can be chronic. It is estimated that in the United~     States chronic prostatitis is responsible for as many as two million doctor visits a year.~     The disease can be ruinous, interfering with work, intimacy, and other things.~      The causes of chronic prostatitis are not understood. The treatments commonly used, including~     antibiotics and prostate massage, work poorly. We now have evidence that laparoscopic~     prostatectomy can eliminate the misery of chronic prostatitis. This trial aims to quantify~     and better characterize the effect of laparoscopic prostatectomy on the symptoms of chronic~     prostatitis.~   "
212860|NCT00773942|"~     The purpose of this study is to determine if a medication therapy management program designed~     to reconcile a patient's medications and identify and resolve drug related problems can~     reduce adverse drug events and other measures of safety and improve patient satisfaction.~   "
212743|NCT00775489|"~     Patients that have consented to participate in the study will be randomly assigned to one of~     two groups: control group or nasal steroid group. Patients in the control group will receive~     normal saline inhaler. Patients in the study group will receive steroid inhaler Follow-up~     visits are: baseline and weeks 2, 4, 6 after starting the spray. Intraocular pressure will be~     recorded on all visits.~   "
212744|NCT00775476|"~     Systemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has~     debilitating and potentially life-threatening consequences. The cause of SLE is unknown and~     current therapies lack specificity and carry significant side-effects. Existing data in the~     literature provide evidence that a natural antioxidant, glutathione, is depleted in T cells~     of patients with SLE. This may be a key factor underlying abnormal activation and~     predisposition of T lymphocytes to pro-inflammatory cell death via necrosis. Administration~     of N-acetylcysteine (NAC), that serves as a precursor of glutathione (GSH), improves the~     clinical outcome of murine lupus, and limits the toxicity of pro-oxidant/immunosuppressant~     medications commonly used in patients with SLE. NAC is widely available in health food stores~     and large doses (up to 8 g/day) can be safely administered to humans. In a one-year study of~     patients with inflammatory lung disease treated with prednisone and azathioprine, addition of~     NAC (1.8 g/day) diminished disease severity and reduced drug toxicity in comparison to~     placebo. Moreover, oral NAC has been found to improve muscle fatigue which is reported to be~     the most disabling symptom in 53% of patients with SLE. Thus, establishing a dose ranging~     between 1.2-7.2 g/day that is well tolerated and capable of raising intracellular GSH in~     lupus patients and determining its immunological and therapeutic impact in SLE appears to be~     well justified.~      The study will consist of two parts, Aim 1 and Aim 2.~      AIM 1:~      The purpose of Aim 1 was to establish the optimal daily oral dose of NAC that can be well~     tolerated without side effects and can normalize or moderate the depletion of GSH in lupus T~     cells.~      36 SLE subjects and 42 healthy controls (matched by age and sex) were studied.~      The 36 SLE subjects were divided into 3 groups of 12. Each group received a different dose of~     NAC (N-acetylcysteine)or placebo as follows:~      Group 1: 9 received 600mg of NAC two times a Day, 3 received placebo; Group 2: 9 received~     1200mg of NAC two times a Day, 3 received placebo; Group 3: 9 received 2400mg of NAC two~     times a Day, 3 received placebo;~      To account for attrition 12 subjects were randomized in each group (9 active, 3 placebo).~      At each subject visit, blood from a healthy donor was drawn and used as control. The control~     blood was used for flow cytometry measurements of GSH and in vitro immunological studies. In~     addition to GSH measurements and immunologic studies, routine labs., ASRS self-reporting~     assessment questionnaire, and SLEDAI/BILAG/Fatigue scores were obtained for the SLE subjects.~     The healthy control subjects also answered the ASRS self-reporting questionnaire. The ASRS~     questionnaire was incorporated into the study procedures in October, 2009. It is designed to~     assess a patient's ability to concentrate which could be affected by the involvement of the~     Central Nervous System (CNS) in lupus. There were up to 5 study visits per SLE subjects in a~     period of four months.~      At each visit up to 100 ml of blood were drawn from each subject. 20 ml are needed for~     routine labs. and up to 80 ml are needed for the GSH and immunological tests.~      Dose comparisons were based on continuous monitoring of adverse events and drug tolerance.~      AIM 2:~      Aim 2 will determine the tolerance and impact of two NAC doses on disease activity and~     prednisone use in 165 subjects with SLE in a double-blind placebo-controlled 12-month study.~     It is designed to detect clinically meaningful differences in disease activity in the patient~     population.~      It was determined by statistical analysis that each group must have 55 subjects. SLE subjects~     will be randomized into 3 groups of 55 subjects to receive 1.2 g of NAC twice a day, 2.4 g of~     NAC twice a day, or placebo. There will be up to seven study visits per SLE subject,~     including the screening and wash out visits. Visits 1-5 will be scheduled three months apart.~     The study will last 13 months with the wash out visit. Each subject will donate approximately~     80 ml of blood for research at each visit. Healthy control subjects will donate blood at the~     same time. They will be matched to the SLE subjects by gender, age within 10 years, and~     ethnicity. Their blood will be used as reference for research assays.~      The inclusion and exclusion criteria will be the same as in Aim 1 and the same subjects may~     continue to participate. There is a new consent form required to participate in the second~     phase.~   "
212745|NCT00775463|"~     This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release~     tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil~     diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance~     produced by the cells of blood vessels that inhibits platelet aggregation, induces~     vasodilation, and suppresses smooth muscle proliferation. Improvement in blood flow in lower~     limbs and fingers would be anticipated to result in a reduction in ischemic pain, Raynaud's~     phenomenon and promote healing of digital ulcers and other ischemic wounds.~   "
212746|NCT00775450|"~     This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone~     revaccination in elderly adults aged ≥ 65 years.~      Primary Objective:~      To describe the safety profile for all subjects.~      Secondary Objective:~      To describe immunogenicity 28 days following revaccination with one of three Fluzone~     formulations.~   "
212747|NCT00775437|"~     The main objective of this study is to evaluate the safety of adalimumab in patients 2 to < 4~     years of age or ≥ 4 years of age weighing < 15 kg, with moderately to severely active~     polyarticular juvenile idiopathic arthritis (JIA) or polyarticular course JIA.~   "
212748|NCT00775424|"~     A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of~     PENNVAX-B with or without co-administration of constructs containing DNA encoding for the~     expression of either IL-12 or IL-15.~      Primary objectives~        1. To determine the safety of HIV-1 DNA constructs (PENNVAX-B).~        2. To determine the safety and optimal doses of the IL-12 and the IL-15 adjuvant constructs~          when given with PENNVAX-B.~      Secondary objectives~        1. To compare the various vaccine groups for their immunological responses to several HIV-1~          antigens, utilizing the ELISPOT assay.~        2. To analyze antibody responses to the vaccine antigens over time.~        3. To measure CD8 cell proliferative responses to vaccine antigens over time.~   "
212749|NCT00775411|"~     The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as~     adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with~     choroidal neovascularization secondary to age-related macular degeneration. Subjects will be~     followed for 26 weeks.~   "
212750|NCT00775398|"~     The purpose of this study is to assess the effect of possible exposure to THROMBIN JMI® on~     activated partial thromboplastin time (aPTT) at 48 hours post surgery in subjects with~     likelihood of prior exposure to THROMBIN JMI® within the past 4 years.~   "
212751|NCT00775385|"~     Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels~     and EGFR mutations would attain better disease free survival rates than patients in the~     control arm receiving noncustomized therapy. Using this selective approach, patients with~     stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive~     cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based~     chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.~      The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will~     enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous~     cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and~     favorable toxicity profile and is of potential interest in the adjuvant setting of resected~     non-squamous NSCLC.~   "
212752|NCT00775372|"~     To compare the single-dose oral bioavailability of clarithromycin 250 mg/5 mL powder for oral~     suspension of Ranbaxy Laboratories with Biaxin 250 mg/5 mL granules for oral suspension in~     healthy, adult, human, male subjects under fed conditions~   "
212753|NCT00775359|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Ranbaxy and Abbott (TriCor) 160 mg fenofibrate tablets under fed conditions.~   "
212754|NCT00775346|"~     A multi-center, prospective, single-visit study designed to acquire physiologic pulse~     oximeter waveform data during standard polysomnography (PSG) studies performed at multiple~     different Sleep Lab Centers.~   "
212755|NCT00775333|"~     The aim of this study is in a prospective, consecutive series of diabetic patients with~     carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having~     idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel~     release.~   "
212756|NCT00775320|"~     The primary objective of this study is to detect and quantify tumor cells of high grade~     malignant gliomas and metastatic brain lesions both before and after initial surgical~     resection in a cohort of newly diagnosed patients.~   "
212757|NCT00775307|"~     The aim of this study is to evaluate the efficacy and safety of pazopanib compared with~     placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely~     resected NSCLC.~   "
212758|NCT00775294|"~     This study is being conducted to look at how the body handles the drug maraviroc. It will~     measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is~     to understand how much of the drug (taken by mouth) reaches the oral, reproductive and~     intestinal tracts. It is believed that the presence of this drug in these areas may be~     beneficial in preventing the AIDS virus (HIV) from being passed from one person to another.~     The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug~     levels. This study will also collect information on side effects.~   "
212771|NCT00775125|"~     The primary objectives are to determine the effect of steady-state DRV/rtv 600/100 mg twice~     daily (b.i.d.) on the steady-state pharmacokinetics of telaprevir 750 mg every (q) 8h and~     1125 mg q12h and vice versa;- to determine the effect at steady-state of fAPV/rtv 700/100 mg~     b.i.d. on the steady-state pharmacokinetics of telaprevir 750 mg q8h and 1125 mg q 12h and~     vice versa; to determine the steady-state pharmacokinetics of telaprevir 750 mg q8h versus~     telaprevir 1125 mg q12h, alone and during coadministration of either steady-state DRV/rtv~     600/100 mg b.i.d or fAPV/rtv 700/100 mg b.i.d.~   "
212861|NCT00773929|"~     The purpose of this study is to determine the safety and toxicity profile of TAK-593 and~     determine the maximum tolerated dose of TAK-593.~   "
212759|NCT00775281|"~     Interstitial cystitis (IC)/chronic pelvic pain syndrome (CPPS) is a clinical syndrome of~     pelvic pain and/or urinary urgency/frequency in absence of a specific cause such as bacterial~     infection or damage to the bladder. The pathogenetic mechanisms of IC/CPPS are as yet~     undefined and it is largely this lack of knowledge, which precludes a systematic therapeutic~     approach. Experimental evidence, including results from the animal models of cystitis and the~     knock-out mice, indicate a participation of tachykinin receptors, especially the NK1R, in~     neurogenic inflammation, which is considered an important element of the IC complex. However,~     there is very scant information about the molecular mechanisms of IC in humans, or of the~     types of receptors, which participate in neurogenic inflammation. Based on our molecular~     biological know-how and the clinical expertise, we propose to investigate the role of the~     tachykinin and bradykinin receptors and their signalling partners in CPPS and bladder~     dysfunction in humans.~   "
212760|NCT00775268|"~     Background:~        -  Positron emission tomography (PET) uses radioactive substances called tracers to locate~          areas of cancer in the body. For this test, the patient is given an injection of tracer~          and lies in a large donut-shaped scanner that detects where in the body the~          radioactivity accumulates. Computed tomography (CT) scans use low dose x-rays that help~          to better localize where the radioactive tracer is concentrating. PET/CT scans are~          usually done in lymphoma patients before treatment starts and at the end of treatment to~          evaluate the response to therapy.~        -  PET scans typically use a sugar-like radioactive tracer called fluorodeoxyglucose (FDG)~          and low-dose x-rays. Sometimes, however, FDG PET scans show what looks like active~          disease and presence of a mass after chemotherapy even when there are no live cancer~          cells. Doctors have particular problems in evaluating response to treatment when this~          happens because they can t tell if the mass is active cancer or just dead tumor cells.~        -  An experimental tracer called 18F- fluorothymidine (FLT) has high uptake in active tumor~          cells and may be better able to evaluate treatment response.~      Objectives:~      - To test the use of FLT PET/CT imaging in assessing treatment response in patients with~     lymphoma.~      Eligibility:~      - Patients 18 years of age or older who are enrolled in a lymphoma therapy study at the NIH~     Clinical Center or in the CALGB 50330 study at another location.~      Design:~      - There are two arms in this study:~        -  The first arm evaluates FLT as an early predictor of tumor response to therapy. Patients~          are imaged with FLT and FDG PET before starting treatment, following two cycles of~          therapy and after treatment ends.~        -  The second arm evaluates the ability of FLT to distinguish if a mass that remains after~          treatment is active cancer or dead tissue. Patients who have completed treatment and in~          whom FDG PET shows a remaining tumor mass are imaged with FLT PET. Following the scan,~          the tumor is biopsied for verification.~   "
212761|NCT00775255|"~     To compare the single-dose oral bioavailability of clarithromycin 250-mg/5 mL powder for oral~     suspension of Ranbaxy Laboratories with that of Abbott Laboratories (Biaxin®) following~     administration of a 250 mg/5 mL dose in healthy, adult, human, male subjects under fasting~     conditions.~   "
212762|NCT00775242|"~     During menopause a woman's body slowly produces less of the hormones estrogen and~     progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and~     osteoporosis. To help with these problems, women are often given estrogen or estrogen with~     progestin. The purpose of this study is to assess and compare the efficacy and safety of~     three doses of estradiol and progesterone for the treatment of the climacteric symptoms~   "
212763|NCT00775229|"~     This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania~   "
212764|NCT00775216|"~     Health disparities related to obesity, pre-diabetes and Type 2 diabetes in the United States~     represent public health concerns. Given the benefit of exercise in disease prevention and~     management, evidence-based, cost-effective, brief interventions are needed to improve patient~     outcomes related to Type 2 diabetes and associated conditions. This novel behavioral~     intervention study connects individuals with resources within their community to affect~     change in their health and wellness. The aim is to connect disparate individuals to health~     and wellness resources to prevent the onset of diabetes. This will be accomplished through a~     collaborative effort with Vanderbilt Diabetes Center, Nashville Metro Parks and Recreation,~     and the Metro Public Health Department.~      A time series design will be used to assess the efficacy of physical activity counseling~     delivered by a health care professional, plus continued contact intervention delivered via a~     proactive and reactive health promotion counseling hotline that will leverage our partnership~     with Metro Parks versus counseling advice alone. In order to refine this intervention (Phase~     II) before it is executed, focus groups will first be conducted in Phase I with members of~     the target population in order to obtain feedback on the proposed intervention activities and~     materials. Qualitative findings and feasibility testing will be the basis for modifying the~     intervention.~   "
212765|NCT00775203|"~     The purpose of this study was to demonstrate efficacy, safety and clinical benefit of~     Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder~     (MDD).~   "
212766|NCT00775190|"~     This is a randomized control trial of Ortho tricyclen versus Trinessa (generic equivalent) to~     determine if they have similar effects. Women will be randomized to receive either Ortho~     tricyclen or Trinessa oral contraceptives and will be asked to keep a daily dairy of any~     symptoms or bleeding experienced. Once a month, participants will be asked to complete a~     survey.~      The objective is to compare generic oral contraceptives (OCPs) and brand name OCPs with~     respect to side effect profiles including bleeding patterns, mood changes, nausea and~     vomiting, frequency of menstrual cramps, breast tenderness, elevation in blood pressure,~     stroke, blood clots and patient compliance.~   "
212767|NCT00775177|"~     The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate~     formulations after administration of single doses to normal healthy subjects under fasted~     conditions. These data were to be evaluated statistically to determine if the products meet~     bioequivalence criteria.~   "
212768|NCT00775164|"~     The primary objective of this study is to examine the effects of four months of pioglitazone~     vs. metformin treatment on HDL cholesterol, triglycerides, blood pressure, insulin~     resistance, endothelial function, arterial stiffness, adipokines, oxidative stress, and blood~     biomarkers of endothelial activation in obese insulin resistant children. 30 obese children~     with elevated fasting insulin levels will be randomly assigned to pioglitazone or metformin~     for 16 weeks. Change in clinical variables over the 16-week study period will be compared~     between groups.~   "
212769|NCT00775151|"~     The objective of this study was to compare the rate and extent of absorption of Ranbaxy~     amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one tablet dose in~     fed state subjects.~   "
212770|NCT00775138|"~     This is a study to determine the safety and tolerability of 28 days of daily dosing of two~     doses (280mg and 560mg) of Arikace™ versus placebo in patients who have Bronchiectasis.~   "
212804|NCT00774696|"~     The objective of this study is to compare the relative bioavailability of clarithromycin 500~     mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy,~     adult subjects under non-fasting conditions.~   "
212772|NCT00775112|"~     We have developed a positioning cushion for LP which allows the child to be relaxed in an~     adequate position, and to maintain this position throughout LP. This study was aimed at~     evaluating the benefit of the device on the technical quality of LPs, on pain, anxiety, post~     LP syndrome, and on the satisfaction of children, their parents and caregivers.~      The study was a two-centre, open, randomized trial, with two parallel groups. Children aged 2~     to 18 years undergoing a LP were eligible, if not included in the study before. Those who had~     used the cushion before, with a medical reason preventing the use of the cushion, those~     refusing or whose parents refused could not be included. Randomization was stratified by~     centre.~      Four cushion sizes were available for the age ranges: 2-6 years, 6-10 years, 10-15 and 15-18~     years. The primary outcome was the rate of success, defined as a LP reaching its objective at~     the first attempt, without hemorrhage (visible hemorrhage or RBC > 50/mm3 in the CSF sample).~     Secondary outcomes included: the child's pain using a visual analogic scale (VAS), parents~     and caregiver perception of the child's pain (VAS); the children, parents, caregiver and~     physician performing the LP satisfaction; children cooperation using the Le Baron Scale,~     and the occurrence of a post LP syndrome.~   "
212773|NCT00775099|"~     Air pollution is a major cause of cardiovascular morbidity and mortality. The components of~     air pollution responsible and the mechanisms through which they might mediate these harmful~     effects remain only partially understood. The link between cardiovascular disease and air~     pollution is strongest for fine particulate matter. Fine particulate matter (PM) is produced~     from the combustion of fossil fuels with the most significant threat thought to be posed by~     small particles less than 10µm (PM 10) which can be inhaled into the lungs. We propose to~     identify the precise component of diesel exhaust that mediates the adverse cardiovascular~     effects using a carbon particle generator, and a particle concentrator. The aim of this study~     proposal is to assess the vascular effects of different types and components of air pollution~     in healthy subjects. We intend to test the hypotheses that:~        1. Combustion derived nanoparticulate causes an acute impairment of endothelial vasomotor~          and fibrinolytic function in healthy volunteers.~        2. Exposure to combustion derived air pollution is associated with increased thrombus~          formation.~   "
212774|NCT00775086|"~     The purpose of this single center, randomized, double-blind, 2 way crossover study was to~     determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal~     contraceptive system.~   "
212775|NCT00775073|"~     This is a prospective open label clinical trial in patients with advanced or metastatic liver~     cancer to assess the clinical and biological activity of RAD001 (Everolimus) in conjunction~     with Bevazicumab (Avastin). Approximately 36 patients will be enrolled.~   "
212776|NCT00775060|"~     To set up a cohort of at least 400 IBS patients in order to identify different patient~     subgroups according to phenotypical and genotypical patterns and~      To set up a biobank for future translational studies on the pathophysiology of IBS, in order~     to identify genetic factors to unravel the pathogenesis of IBS and to provide novel~     therapeutic targets.~   "
212777|NCT00775047|"~     The purpose of this study is to see if it is a feasible arrangement to have women receive~     their second and third birth control injection (with Depo-Provera) at a pharmacy compared~     with receiving it a Planned Parenthood Clinic. Compliance with returning for injections as~     well as patient satisfaction with the method, providers, and location where injection was~     received will be assessed and compared between the two sites. The hypothesis is that there~     will be no difference in return rates for injections at either the pharmacy or the clinic~     site.~   "
212778|NCT00775034|"~     Mesh repair for open incisional hernia repair with fibrin sealant or with drainage~   "
212779|NCT00775021|"~     The objective of this study is to evaluate the clinical performance of two daily disposable~     contact lenses.~   "
212780|NCT00775008|"~     A media lab study will be conducted to determine the mechanism by which podcasting may exert~     an effect. This study will examine both physiological (heart rate, skin conductance, etc.)~     and psychosocial (knowledge, perceived control, elaboration, etc.) measures in participants~     listening to a podcast on health versus reading health content on the Web. We hypothesize~     that podcasting will create a greater physiological response than the Web. There will also be~     more elaboration in the podcasting group. Podcasting will produce greater feelings of~     control. Changes in knowledge will be greater in the Web group.~   "
212781|NCT00774995|"~     This study will evaluate the immune response of healthy subjects who received neonatal~     vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The~     presence of immune memory against hepatitis B surface antigen (HBsAg) in these subjects will~     be investigated by the administration of a challenge dose of hepatitis B vaccine and the~     comparison of their antibody concentration before and one month after vaccination.~      This protocol posting deals with objectives & outcome measures of the booster phase. No new~     subjects will be recruited during this booster phase of the study.~   "
212782|NCT00774982|"~     The study is being conducted to evaluate the pharmacokinetic parameters (Cmax, Tmax and AUC)~     of the new delayed release, lowered dose, 40 mg 6MP test formulation as compared to standard~     6MP (100 mg Purinethol) in 12 patients with Crohn's Disease.~      The study is being undertaken to prove that the new test formulation is indeed~     delayed-release and targeted to the ileum, and that the levels of 6MP in the blood following~     local absorption are lower than that seen following standard Purinethol dosing. This should~     result in lower, safer mercaptopurine dosing, allowing for uninterrupted treatment with fewer~     side effects.~   "
212783|NCT00774969|"~     The purpose of this study is to evaluate the blood levels of Metronidazole after application~     to the peri anal area after a single dose and 6 or 7 days application.~   "
212784|NCT00774956|"~     The purpose of this study is to investigate the muscle recruitment pattern and the effect of~     a 6 week shoulder exercise training program in healthy persons and subjects with shoulder~     impingement~   "
212785|NCT00774943|"~     This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of~     repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.~   "
212786|NCT00774930|"~     The purpose of this study was to determine whether monthly deep subcutaneous (s.c.)~     injections of lanreotide Autogel (Somatuline Depot) were effective and safe in controlling~     diarrhoea and flushing by reducing the usage of s.c. short-acting octreotide as a rescue~     medication to control symptoms in subjects with carcinoid syndrome.~   "
212787|NCT00774917|"~     This is a prospective single centre Study designed to assess by OCT the effect of NUMEN~     cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native~     coronary lesions of patients with Stable Angina Pectoris or ACS (except STEMI).~      A total of 60 consecutive patients will be enrolled in the study. Patients with de novo~     native coronary artery lesions >10mm and <24mm in length and >2.50mm to <3.50mm in diameter~     by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent~     implantation. After stent deployment an OCT imaging will be performed within the treated~     segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with~     all patients having repeat angiography and OCT at 6 months.~      It is anticipated that the total length of the study will be 18 months: 6 months to complete~     patient enrolment and 12 months for follow-up.~   "
212788|NCT00774904|"~     Plasma adiponectin concentration is inversely associated with renal function. There is little~     literature on adiponectin levels and regulation by antihypertensive medication with an~     angiotensin II-receptor blocker (ARB), especially in subjects with type 2 diabetes in~     different stage of chronic kidney disease (CKD).~   "
212789|NCT00774891|"~     This study will compare the physiologic responses between exercise stress echocardiography~     and pharmacologic stress echocardiography on left ventricular volume and wall stress.~   "
212790|NCT00774878|"~     The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with~     fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of complete~     response, partial response and stabilization of the disease.~      The additional objectives are to evaluate the safety profile of AVE1642 in combination with~     fulvestrant and of fulvestrant alone, to assess the rate of patients without disease~     progression at 6 months and the overall progression-free survival time. An evaluation of the~     pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also~     be performed.~      The biological activity of treatment will be assessed on tumor biopsies, when possible The~     potential immunogenicity of AVE1642 will be studied~   "
212791|NCT00774865|"~     The objectives of the 2-year study are two-fold:~        1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft of~          patients who have already had robotically-assisted CABG surgery using CTA and MPS-MIBI~        2. To determine patient quality of life at 5-7 years after robotically-assisted CABG~          surgery~   "
212792|NCT00774852|"~     This study is for individuals with lupus who have developed complications in their kidneys,~     or lupus nephritis. The study will determine whether adding the experimental medication~     abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis~     than standard cyclophosphamide therapy by itself.~   "
212793|NCT00774839|"~     The purpose of this study is to learn more about the social and financial impact of colon~     cancer for older patients. We want to know how cancer has affected the patient financially~     and socially, and to know if the patient has resource needs that have gone unmet. By doing~     this study, we hope to learn about resources that can reduce the financial burden from~     cancer.~   "
212794|NCT00774826|"~     The purpose of this study is to define an improvement and theassessment of the Time to~     Treatment Failure in patients randomized in three different arms:~      R−CVP vs R−CHOP vs R−FM.~   "
212795|NCT00774813|"~     The primary objectives of this Phase II study are to demonstrate the safety of Nexalin~     Therapy and to investigate the efficacy of Nexalin Therapy.~   "
212796|NCT00774800|"~     Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA)~     approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase~     PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of~     other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and~     Humulin-R in order to determine if it improves the absorption of these insulins to more~     closely mimic the body's natural increase in insulin in response to a meal.~   "
212797|NCT00774787|"~     The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy~     of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and~     new ones) at follow-up.~   "
212798|NCT00774774|"~     This work aims to measure the effectiveness of face mask worn by a patient with flu to avoid~     transmission to other persons in the household.~   "
212799|NCT00774761|"~     The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two~     doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.~   "
212800|NCT00774748|"~     The purpose of this study is to ascertain whether subcutaneous ports are an effective and~     reliable way to administer the low molecular weight heparin (LMWH) enoxaparin to patients for~     the prevention or treatment of venous thromboembolism.~   "
212801|NCT00774735|"~     A study in healthy volunteers to determine whether there is a drug interaction between~     GSK1349572 and the HIV protease inhibitors lopinavir/ritonavir and darunavir/ritonavir~   "
212802|NCT00774722|"~     The purpose of this study is to determine whether metronidazole 10% ointment , applied~     topically three times a day in and around the anus, on the reduction of pain following~     haemorrhoidectomy.~   "
212803|NCT00774709|"~     Background:~      Heart failure with preserved ejection fraction (HFPEF) is common but not well understood.~     Electrical dyssynchrony in systolic heart failure is harmful. Little is known about the~     prevalence and the prognostic impact of dyssynchrony in HFPEF.~      Methods:~      We have designed a prospective, multicentre, international, observational study to~     characterize HFPEF and to determine whether electrical or mechanical dyssynchrony affects~     prognosis. Patients presenting with acute heart failure will be screened.~      Inclusion criteria will be:~      acute presentation with Framingham criteria for heart failure, left ventricular EF ≥45%, BNP~     >100 ng/L or NT-proBNP >300 ng/L. Patients will return in stable condition 4-8 weeks after~     the index presentation and undergo questionnaires, serology, ECG and Dopplerechocardiography.~     Thereafter, patients will be followed for mortality and heart failure hospitalization every 6~     months for at least 18 months. Sub-studies will focus on echocardiographic changes from the~     acute presentation to the stable condition and on exercise echocardiography.~      Conclusion:~      KaRen aims to characterize electrical and mechanical dyssynchrony and to assess its~     prognostic impact in the HFPEF. The ancillary study of the exercise stress echocardiography~     sought to improve our understanding of HFPEF and generate answers to the question whether~     dyssynchrony could be a target for therapy in HFPEF.~   "
212805|NCT00774683|"~     The purpose of this research sub-study is to learn about the levels of an antiretroviral~     (ARV) medication called Raltegravir, and response to HIV virus in the genital tract of~     HIV-positive women.~      We would like to see how this study medication is tolerated, and how the body processes the~     study medication in women who are HIV-positive. More specifically, we are interested in how~     Isentress® might penetrate into the female cervicovaginal secretions thereby potentially~     reducing the amount of HIV in those secretions. A reduction in the amount of HIV in genital~     secretions may prevent female subjects from transmitting HIV to their sexual partners. This~     information will help the research team know how a medication such as Isentress® might be~     used to prevent the sexual transmission of HIV.~   "
212806|NCT00774657|"~     This preliminary study will compare the effectiveness of two-dimensional and~     three-dimensional echocardiographic measurements of wall thickness and left ventricular mass~     in patients with Aortic Stenosis~   "
212807|NCT00774644|"~     The objective of this study is to compare the relative bioavailability of clarithromycin 500~     mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy,~     adult subjects under fasting conditions.~   "
212808|NCT00774631|"~     Bacterial meningitis is a severe infection of the envelope which surrounds the brain. It is~     sometimes responsible for a cerebral oedema mattering with a loss of consciousness (coma).~     The usual treatment of this affection is based on the antibiotic therapy, anti-inflammatory~     drug and resuscitation measures in intensive care setting but the prognosis of comatose~     patients remains poor.~      Moderate hypothermia (body temperature is downed between 32 and 34°C°) made the proof of its~     efficiency in certain cerebral pathologies (notably the cerebral distress after cardiac~     arrest or oxygen lack in neonates) but was never evaluated in meningitis. In meningitis~     animal studies and in severe traumatic brain injury, moderate hypothermia is able to diminish~     cerebral oedema and brain inflammation.~      Thus, the objective of this study is to compare two strategies: only usual care or usual care~     completed by moderate hypothermia. The body temperature will be lowered between 32 and 34°C~     by means of a catheter placed in a big vein and connected to a machine in which circulates a~     cold liquid, or by means of an external cooling (ice-cold blanket, ice packs placed on the~     body). Whatever technique is chosen, the technique is perfectly mastered by the teams which~     take charge of the patients. After 48 hours, the technique of hypothermia will be suspended~     and body temperature will return passively and gradually to normal.~      The investigators believe that moderate hypothermia will improve the prognosis of the most~     severe patients.~   "
212809|NCT00774618|"~     Individuals with non-healing rib fractures may experience significant pain and disability.~     This is called rib fracture non-union, an unusual problem and one that most physicians have~     little experience with. The investigators hypothesize that surgical repair of rib fracture~     non-union is clinically efficacious and safe in 6 month follow-up. The objective of this~     study is to evaluate how repairing non-healing rib fractures affects pain and disability.~   "
212810|NCT00774605|"~     To evaluate the absorption, safety, and tolerability of a varenicline solution and a~     varenicline patch applied to the skin.~   "
212811|NCT00774592|"~     This study will examine whether pairing a grade 6 in-school HIV education program and a~     parent training program will reduce prevalence of behaviors that present high risk of HIV~     infection in youth in the Bahamas.~      In a continuation of this study, we shall examine whether an in-school HIV prevention program~     delivered to grade 10 students reduces HIV risk behavior and the impact of both the grade 6~     intervention and the grade 10 intervention compared to the grade 6 intervention alone.~   "
212812|NCT00774579|"~     We will examine a cohort of growth hormone deficient adults starting growth hormone (GH)~     replacement. The purpose of this study is to determine whether GH replacement reduces the fat~     content of the liver.~      To compare the results we will include growth hormone deficient patients who do not start GH~     replacement as controls.~   "
212813|NCT00774566|"~     This study is designed as a randomized, controlled, prospective, non-inferiority clinical~     trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated)~     will be compared to the standard ablation technique (segmental isolation of the pulmonary~     veins) with radiofrequency energy. The primary study aim is to investigate whether the new~     cryoballoon ablation catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable~     Sheath, CryoCath Technologies Inc., Montreal, Canada) is at least as effective as~     radiofrequency (RF) segmental isolation in electrically disconnecting the pulmonary veins~     (PV) for the treatment of paroxysmal atrial fibrillation (AF) with respect to the absence of~     atrial arrhythmias without persistent complications after six and twelve months. Furthermore,~     the differences in terms of procedural complications such as pulmonary vein stenosis, phrenic~     nerve injuries, cerebrovascular accidents (CVA), pericardial tamponade, pain scores during~     the procedure, levels of cardiac inflammatory markers are compared between the treatment~     groups. The short and long-term clinical success as well as the costs of both systems will~     also be evaluated.~   "
212814|NCT00774553|"~     The purpose of this study is to assess safety and tolerablility of AZD1656 after multiple~     repeated oral doses in patients with type 2 diabetes on top of metformin.~   "
212815|NCT00774540|"~     The purpose of this study is~        1. to observe acute pain after surgery and measure the natural course of inflammatory~          mediators~        2. study pain relieving effects and local anti-inflammatory effects of systemically~          administered ketorolac~   "
212816|NCT00774527|"~     Randomized comparison of cyclophosphamide versus reduced-dose cyclophosphamide plus~     fludarabine in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic~     hematopoietic cell transplantation for bone marrow failure syndrome.~   "
212817|NCT00774514|"~     Exposure to air pollution has been linked to increased cardiorespiratory morbidity and~     mortality. The exact component of air pollution that mediates this effect is unknown, but the~     link is strongest for fine combustion derived particulate matter derived from traffic~     sources. It has been demonstrated that inhalation of diesel exhaust impairs vascular~     vasomotor tone and endogenous fibrinolysis. Recent studies using an inline retrofit particle~     trap to reduce the particulate component of exhaust have shown that filtering particles leads~     to a reversal of the endothelial dysfunction seen after diesel exhaust exposure, and have~     even suggested an augmentation of vascular function. This raises the question of the~     cardiovascular effects of the gaseous pollutants, the most abundant of which is nitrogen~     dioxide. In this study we plan to investigate the cardiovascular effects of nitrogen dioxide~     exposure.~   "
212818|NCT00774501|"~     Liver tumors are hard to treat with radiation because the liver moves every time you breathe.~     The purpose of this study is to test a new and possibly more accurate way of treating liver~     tumors. When a person is asleep under anesthesia, it is safe to stop breathing motion for a~     while. The liver will stop moving and radiation can be given to a liver tumor. The study is~     being done to see if radiation can be given to liver tumors safely and accurately in this~     way.~   "
212819|NCT00774488|"~     This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the~     acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on~     metabolic parameters and gene expression in subcutaneous adipose tissue.~   "
212820|NCT00774475|"~     The purpose of this study is to evaluate the efficacy (reduction of major ischemic events at~     6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI~     undergoing PCI with stent implantation and wiht a documented residual platelet reactivity~     assessed by a point of care system (VerifyNow P2Y12).~   "
212821|NCT00774462|"~     The traditional treatment of inflammatory myopathies (IM) and generalized myasthenia gravis~     (MG) is immunosuppressive therapy, usually beginning with corticosteroids. However, up to 70%~     of treated patients show an incomplete response, including 10 - 30% who are unresponsive.~     Corticosteroids and other immunosuppressive therapies presented also many side effects. We~     propose to evaluate in a pilot, open, prospective, multicentric, phase II study, the interest~     of rituximab in the treatment of patients with primary IM associated with specific AAb~     (anti-synthetase and anti-SRP AAbs), or MG (with anti-AchR AAbs), refractory to conventional~     therapies. Twenty fourth patients with primary IM (12 with anti-synthetase, 12 with anti-SRP~     AAbs), and 12 with MG will be included in the study.~   "
212822|NCT00774449|"~     Chronic organ dysfunction after lung transplantation (BOS) is the most common cause of death~     in long-term survivors after lung transplantation and refractory to most interventions. Early~     markers will be established in this project study to overcome the problem of disease~     recognition when impairment of graft function is already taken place. Long-term longitudinal~     monitoring in stable recipients of innovative markers of airway inflammation and ventilation~     and new imaging techniques will define different entities of chronic organ dysfunction after~     LTx. A database and specimen service unit for further projects will be created.~      Hypothesis: This project will reveal new markers and imaging tools in recipients who develop~     BOS after lung transplantation. These tools will allow earlier diagnosis and more accurate~     monitoring of the disease process. Different patterns of the disease will be characterized.~   "
212823|NCT00774436|"~     The purpose of this study is to find out if men, with low-risk prostate, can have the small~     amount of cancer within their prostate removed by freezing, called Focal Cryoablation or~     Cryotherapy.~   "
212824|NCT00774423|"~     This is a multicentric, randomized, double-blind study versus placebo, with two parallel~     groups treated to evaluate the efficacy and the tolerance of Riluzole in children and young~     adults (6 to 20 years of age) with SMA. (Type II and Type III).~   "
212825|NCT00774397|"~     The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI~     201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus~     (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated~     interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed~     in treatment-naïve (TN) and treatment experienced (TE) patients.~   "
212826|NCT00774384|"~     Meningitis or septicaemia (blood poisoning) caused by group B meningococcal infection (MenB)~     is an important cause of death and disability in the UK. Prevention through vaccination~     therefore remains a key public health priority. Research from national meningitis vaccine~     programmes against MenC, Hib and Streptococcus pneumoniae show us that their success is in~     part due to their ability to protect both the vaccinated and the unvaccinated, so−called herd~     immunity. This protection probably occurs by reducing carriage of these meningitis bacteria~     in the back of the throat (mucosal immunity). How this happens is poorly understood but our~     research shows that naturally acquired immunity (transient contact between the immune system~     and the meningococcus in the back of the throat without causing disease) may impact on this~     process. We believe that to develop a MenB vaccine that is able to cause mucosal immunity and~     prevent MenB carriage, it is important to understand the interaction between natural immunity~     and vaccination. In this study we propose to administer MenB vaccine to adults in order to~     investigate this process. Our findings will provide important insights into Men B immunity,~     inform the design of novel vaccine strategies and allow the rational testing of new vaccines~     as they become available.~   "
212827|NCT00774371|"~     Overweight or obesity is an established negative prognostic factor in both premenopausal and~     postmenopausal breast cancer. Several mechanisms have been proposed to explain the adverse~     effect of excess body fat on prognosis following the diagnosis of breast cancer, including~     increased circulating sex hormones, insulin, leptin, and various growth factors. Results from~     previous studies suggest that specific strategies can facilitate weight reduction and~     maintenance of weight loss in this target population. This randomized clinical trial will~     recruit 253 overweight or obese women who have been previously treated for early stage breast~     cancer and will test whether a multifaceted approach to promoting healthy weight management~     can achieve the goal of weight loss and maintenance. Additionally, this study tests whether~     weight loss is associated with changes in biological and psychosocial factors, including~     eating attitudes and behaviors and health-related quality of life. The intervention~     incorporates cognitive-behavioral therapy, increased physical activity, diet modification to~     facilitate a modest reduction in energy intake, and strategies to improve body image and~     self-acceptance. This approach and intervention have been pilot-tested with breast cancer~     survivors in a developmental project, which resulted in the intervention group losing~     significantly more weight than the wait-list control group.~      Study Aims include: testing whether an intervention that emphasizes increased physical~     activity and individualized diet modification to promote an energy imbalance is associated~     with a greater degree of weight loss and maintenance of that loss over an 18-month time~     period; describing the effect of the intervention on hormones and growth factors; describing~     the relationships between body weight and weight reduction and measures of selected~     psychosocial factors. Measurements of hormonal and psychosocial factors in this study will~     provide insight into the responsiveness of these factors to weight loss in overweight or~     obese breast cancer survivors, which will provide an indication of the degree of clinical~     benefit that is achieved with the intervention efforts. Results from this study may enable~     the development of broader efforts transferable to clinical practice and public health, and~     thus, may ultimately have a substantial effect on the risk for recurrence and long-term~     survival of the estimated 1.98 million breast cancer survivors in the U.S. today.~   "
212838|NCT00774228|"~     To evaluate the safety and performance of the I-ZIP Ocular Bandage in subjects undergoing~     uneventful unilateral clear corneal phacoemulsification with foldable monofocal intraocular~     lens (IOL) implantation compared with the Oasis 24-hour Soft Shield Collagen Corneal Shield~     (Oasis Medical, Inc. Glendora, California) for providing ocular protection and relief of pain~     or discomfort in the acute post-operative period.~   "
212828|NCT00774358|"~     Funding Source--FDA OOPD.~      Orphan Product Grant Number--1R01FD004091-01A1~      Context: Wiskott-Aldrich syndrome (WAS) is a fatal, devastating disease with ill-defined~     treatment modalities, which affects young boys. Classic WAS is characterized by a clinical~     triad of thrombocytopenia, eczema and severe, recurrent infections. Despite diagnostic and~     therapeutic advances most WAS patients die at less than 12 years of age due to infections,~     hemorrhage, malignancy or complications from treatments. WAS patients suffer from herpesvirus~     infections as a result of poor Natural Killer (NK) cell function (cytotoxicity). In the~     laboratory, the investigators have seen correction of WAS Natural Killer Cell (NK) function~     after treatment with Interleukin-2 (IL-2).~      Objectives: Initiate a prospective clinical trial by treating WAS subjects with IL-2 and~     using safety as the primary endpoint. Restoration of NK cell cytotoxicity and effects on~     cytoskeletal dynamics are secondary endpoints. The investigators will also observe patient~     clinical status (eczema, infections, use of treatment dose antibiotics, food allergies, etc).~      Study Design/Setting/Participants: This is a prospective clinical trial treating 9 WAS~     subjects in the Clinical Translational Research Center (CTRC) with IL-2.~      Intervention: The investigators propose to subcutaneously administer 0.5 Million Units~     (MU)/m2 of IL-2 daily to WAS subjects for 5 days. Research treatment will be repeated 2 and 4~     months later. Inter-patient dose escalation will be employed to 1 MU/m2 and/or 2 MU/m2 based~     on safety as the primary endpoint.~      Study Measures: The investigators will observe safety and tolerability measures and perform~     assays on subject blood samples prior to and after research treatment to observe improvement~     in NK cell function.~   "
212829|NCT00774345|"~     The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective~     as a maintenance therapy at improving further the quality of the response you achieved with~     your last therapy and at prolonging the duration of your response. This study will compare~     the effects (good and bad) of lenalidomide with the dummy drug.~   "
212830|NCT00774332|"~     A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL~   "
212831|NCT00774319|"~     The purpose of this trial is to compare two different treatments for fit patients with head~     and neck cancer:~      All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU).~      Subsequently patients are being randomised into two groups:~        -  The first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and~          conventional radiotherapy~        -  The second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and~          accelerated radiotherapy.~   "
212832|NCT00774306|"~     The purpose of this study is to determine if certain seizure medications raise levels of~     cholesterol and other blood components which could increase the risk of heart attacks and~     strokes.~   "
212833|NCT00774293|"~     Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic~     association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal~     circulation, to alleviate inflammation, haemorrhage, myocardial ischemia and pain. This is a~     pilot study; a confirmative study will be set up if this study is positive.~      The study treatment will start the day before surgery, and will comprise 5 granules of each~     homoeopathic medication, Arnica 5 CH and Bryonia 9 CH, or their matching placebo TID during 5~     days, in addition to all routine treatments.) Two groups of 45 patients will be included.~     Patients have to be over 18 years, to undergo aortic valve surgery only, have no known~     allergy to one of the study drugs, sign a consent form, and must not have received anti~     inflammatory drug in the 3 days before surgery. The primary criteria include the amount of~     drained liquid from the chest, and the CRP evolution from baseline to the 7th postoperative~     day. Secondary criteria address inflammation, haemorrhage, ischaemia, and pain. A follow-up~     phone call is given to the patients 30 days after their surgery.~   "
212834|NCT00774280|"~     1. At the same time of registration, patients will be randomized to one of the two~          conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or~          Arm II (intravenous busulfan plus fludarabine; BuFlu).~        2. Randomization will be a stratified permuted-block design. 2.1The patients will be~          stratified into standard risk vs. high risk group, and related vs. unrelated donor.~          Standard risk group will be defined as follows: patients with acute leukemia in first~          remission, CML in chronic phase, and MDS (RA or RARS categories). High risk group will~          be defined as follows: patients with acute leukemia in relapse or in second or~          subsequent remission, CML in accelerated or blastic phase, and MDS (CMMoL or RAEB~          categories).~      2.2.Pre-assigned block size is 8.~   "
212835|NCT00774267|"~     The objective of the study is to evaluate quantitative changes in mammographic breast density~     from baseline to 24 months in postmenopausal women receiving daily doses of either BZA 20~     mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, Raloxifene or placebo. The primary endpoint in this~     study is the change in mammographic breast density between baseline and month 24 for each~     group.~   "
212836|NCT00774254|"~     This study is part of an effort to learn about interactions between doctors and patients. The~     study will use virtual reality technology to examine how patients and doctors interact when~     they discuss disease risks.~      Men and women between the ages of 25 and 40 who have access to the Internet and were born and~     raised in the United States may be eligible for this study. Participants will be recruited~     from the Washington D.C. area.~      Participants undergo the following procedures:~        -  Complete an online questionnaire about their health-related background, family health~          history, cancer risk perceptions, and demographic information (e.g., age, marital~          status, education, etc.).~        -  Participate in activities in a virtual reality environment in which they interact with a~          virtual doctor in a virtual clinical scenario. For this experiment, participants wear a~          head-mounted display that allows them to see the virtual world images.~        -  Fill out a second questionnaire after completing the virtual reality activities. This~          questionnaire includes information on the participants virtual reality experience, the~          information provided in the experience, and questions about themselves and their~          background.~   "
212837|NCT00774241|"~     This single arm study will assess the efficacy and safety of first line combination treatment~     with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients~     will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6~     cycles). The anticipated time on study treatment is until disease progression, and the target~     sample size is 100 individuals.~   "
212840|NCT00774202|"~     This study is designed to compare the efficacy and safety of higher doses of Rituxan with a~     regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not~     respond to or relapsed after standard doses of Rituxan. Patients eligible for this protocol~     will be stratified into two subgroups according to their initial response to Rituxan.~   "
212841|NCT00774189|"~     The objective of the study was to compare the single-dose oral bioavailability of~     Clarithromycin 250 mg tablets of Ranbaxy Laboratories with Biaxin 250 mg tablets of Abbott~     Laboratories in healthy, adult, human subjects under fasting conditions~   "
212842|NCT00774176|"~     The overall purpose of PA-SCOPE is to determine why black and rural residents of Pennsylvania~     might be at higher risk for deadly, debilitating, and costly hospitalizations for chronic~     obstructive pulmonary disease (COPD)— and then to show that repeat acute exacerbations in~     high-risk patients can be reduced with one simple intervention. We believe that 1) COPD~     patients who are black or who live in rural areas of Pennsylvania are at higher risk of acute~     exacerbations requiring hospitalization and 2) this elevated risk can be reduced with one~     simple intervention: access to a 1-800 Temple Call Center where patients can get immediate~     customized advice on managing COPD exacerbations in their early stages. We will test these~     beliefs in PA-SCOPE. The collaborators with Temple University Hospital on the PA-SCOPE~     project are Lancaster General Hospital, Western Pennsylvania Hospital, and the Philadelphia~     College of Osteopathic Medicine.~   "
212843|NCT00774163|"~     This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in~     healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial~     to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of~     pediatric diarrhea in Peru.~   "
212844|NCT00774150|"~     The purpose of this study is to investigate neurobehavioral, affective, and social processes~     that may influence and predict treatment response in pediatric anxiety disorders.~   "
212845|NCT00774137|"~     People who undergo coronary artery bypass grafting (CABG) or heart valve surgery may~     experience acute kidney injury (AKI) after their surgery. Current medical tests cannot~     identify AKI until approximately 48 hours after it occurs. This study will examine three new~     biomarkers in blood and urine that may provide a more effective and faster way of predicting~     AKI in people who undergo CABG or heart valve surgery.~   "
212846|NCT00774124|"~     Our objective is to test an innovative approach to improve outcomes among underserved women~     with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR)~     -enabled telephone system to facilitate diabetes control and thereby improve pregnancy~     outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby~     reducing infant birth weights and leading to improved pregnancy outcomes.~   "
212847|NCT00774111|"~     A study in healthy volunteers to determine whether there is a drug interaction between~     GSK1349572 and etravirine~   "
212848|NCT00774098|"~     We would like to study the effect of preserving liver glycogen storage by using intravenous~     dextrose infusion on postoperative liver function and complications after major liver~     resections.~   "
212849|NCT00774085|"~     The purpose of this study is to assess treatment and outcomes data in patients receiving~     treatment with long-acting injectable risperidone.~   "
212850|NCT00774072|"~     The purpose of this study is to determine whether the nasal inhalation of Gernebcin® is~     effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.~   "
212851|NCT00774059|"~     The study is using a new breast lift system to complement a breast-lift operation.~      In general there will be recurrence of breast-ptosis after a correcting operation.~      With this device we want to minimize this recurrence and provide an internal bra.~   "
212852|NCT00774046|"~     The purpose of this study is to determine the effectiveness of a particular combination of~     drugs used to treat cancer.~   "
212853|NCT00774033|"~     The aim of the study is to compare results obtained with epidermal cell spray and classic~     skin grafting for epidermal replacement in acute burns~   "
212854|NCT00774020|"~     The purpose of this study is to document the efficacy and safety profiles of single~     intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone~     (PDB).~   "
212855|NCT00774007|"~     Emerging evidence indicates the presence of low-grade mucosal inflammation and its~     pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment~     of IBS patients reduces low grade colonic inflammation.~   "
212856|NCT00773994|"~     This prospective research study seeks to determine how the normal velopharyngeal mechanism~     compares, both anatomically and physiologically, with previous data obtained on subjects with~     submucous cleft palate (SMCP) in IRB#07080395.~   "
212857|NCT00773981|"~     Anastomotic leakage is a major and potentially mortal complication with an incidence of~     10-13% after resection of the rectum. For patients showing no clinical signs of peritonitis,~     the traditional method has been a conservative treatment with transrectal rinsing. This~     treatment is often associated with a very protracted postoperative course with healing times~     of up to a year or more for the anastomotic leakage.~      Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy.~      The objective of this study is to investigate the effects of transrectal vacuum treatment on~     the healing of anastomotic leakage after rectum resection in a prospective, randomized,~     controlled multicentre trial in 60 patients found to develop clinically significant~     anastomotic leakages after elective rectal resection.~   "
212858|NCT00773968|"~     This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety~     and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA)~     in predialysis participants with chronic renal anemia. Participants currently receiving~     subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy~     polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or~     360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week~     -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range~     of 10 to 12 grams per deciliter (g/dL).~   "
212859|NCT00773955|"~     This phase II trial is studying how well R-(-)-gossypol acetic acid works in treating~     patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy,~     such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~   "
212862|NCT00773916|"~     The purpose of this study is to investigate the association of adverse environmental factors,~     parental psychopathology, family functioning and genetic factors and the response to~     methylphenidate treatment in children and adolescents with Attention Deficit/Hyperactivity~     Disorder.~   "
212863|NCT00773890|"~     This study is designed to assess the safety, tolerability, and activity of TRF-1101 on~     microvascular blood flow, vascular endothelial injury, and vasoocclusive pain associated with~     sickle cell disease.~   "
212864|NCT00773877|"~     Measurement of RNFL thickness by OCT is at a cornerstone for the correct diagnosis and~     monitoring of progression of glaucomatous optic neuropathy.~      Spectral domain technology has enabled better reproducibility with better axial resolution in~     the measurement of RNFL thickness. A comparative study among Stratus, Cirrus and RT-View will~     enable clinicians to determine differences among various instruments.~   "
212865|NCT00773864|"~     Medical staff will be screened for MRSA and ESBL (including: doctors, nurses, nurse aids,~     physical therapists, dietitians, Janitors and other medical staff).~      PURPOSE:~      To define the carriage of, and risk factors for carriage of resistant organisms among~     healthcare employees of carriers of resistant bacteria.~      To define activities of healthcare employees who likely to lead to dissemination of resistant~     bacteria in rehabilitation centers.~   "
212866|NCT00773851|"~     Hernia of the abdominal wall occur frequently after various surgical procedures of the~     abdomen and are increasingly performed by laparoscopic means. Different mesh fixation~     techniques are applied, but the influence of mesh fixation on shrinkage is not known in human~     patients. Therefore, mesh shrinkage was assessed using two different techniques for fixation.~   "
212867|NCT00773838|"~     Study of vorinostat in combination with bortezomib in patients with relapsed or refractory~     multiple myeloma after at least 2 prior treatment regimens.~      Histone deacetylases (HDAC) facilitate gene transcription by modulating the uncoiling of~     chromatin. HDAC function is dysregulated in hematologic and solid malignancies, and this~     dysregulation may result in over-expression of oncogenes. Thus, inhibition of HDACs may~     result in anti-cancer effects. HDAC inhibitors, like vorinostat, represent a new class of~     antitumor agents that have the ability to induce antiproliferative effects including~     cyto-differentiation, cell cycle growth arrest or apoptosis in various cancer cell lines.~     Several studies have investigated the in vitro antimyeloma activity of vorinostat in~     combination with bortezomib and have demonstrated that vorinostat may act synergistically~     with bortezomib to modulate tumor cell growth. Mitsiades et al have shown that vorinostat~     enhances the sensitivity of bortezomib. Pei et al found that exposure of human multiple~     myeloma cell lines &amp; patient-derived multiple myeloma cells to bortezomib and vorinostat~     resulted in synergistic interactions as a result of: (1) Interruption of NF-kB & related~     signaling pathways (JNK, XIAP, Mcl-1, etc.) (2) Inhibition of Hsp90 (3) Induction of ER~     stress signal and (4) acetylation of Dynein/ disruption of aggresome function/formation,~     salvage for ubiquitinated proteins. In addition a marked increase in mitochondrial injury,~     caspase activation, and apoptosis was also observed.~      Bortezomib is indicated for the treatment of patients with multiple myeloma. Two Phase I~     dose-ranging studies of a regimen combining vorinostat and bortezomib among patients with~     relapsed as well as end-stage, refractory multiple myeloma have been conducted. These studies~     enrolled a total of 57 patients. In these studies, administration of vorinostat with standard~     doses of bortezomib resulted in responses in 20/45 (44%) evaluable patients (Weber et al~     2007, Badros et al 2007). The purpose of the present study is to definitively evaluate the~     clinical activity of vorinostat in combination with bortezomib in patients with multiple~     myeloma.~      Based on the preliminary safety & efficacy presented by Weber et al and Badros et al at ASH~     2007, this protocol will further evaluate the clinical activity of vorinostat in multiple~     myeloma.~   "
212868|NCT00773825|"~     Genomic imprinting, referring to an epigenetic marking resulting in monoallelic gene~     expression, plays a critical role in development. Recently, various imprinting diseases were~     reported in animals (Large Offspring syndrome (LOS)) and humans (Beckwith-Wiedemann syndrome~     (BWS) and Angelman syndrome (AS)) born after ART. In all cases, an imprinting defect was~     involved (loss of methylation at ICR2 in BWS, at SNRPN in AS and at IGF2R DMR2 in LOS). These~     data suggest that ART procedures may impair the establishment or the maintenance (following~     fertilization) of methylation marks at maternally imprinted loci. In view of these data, the~     aim of this study is to determine if children born following ART exhibit an increased risk of~     imprinting defects. If the answer is yes, the second objective is to identify the problematic~     step in the ART procedure and thus to suppress or modify this step.~   "
212869|NCT00773812|"~     The purpose of this study is to examine the safety and efficacy of mecamylamine for the core~     symptoms of autism.~   "
212870|NCT00773799|"~     Data on occurrence of antimicrobial resistant bacteria acquisition in rehabilitation centers~     will be collected. After removal of patient identifiers, information regarding the patients~     population will be entered into electronic sheet. The phase will last twelve months in each~     center.~   "
212871|NCT00773786|"~     This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this~     study will provide proof-of-concept information on whether the (anticipated) additional~     bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in~     the patient-centered outcome, exercise capacity. This study will only evaluate the effects of~     short-term (1-week) administration of Brovana. If results are positive, it would provide~     preliminary data for further, multicenter investigations.~   "
212872|NCT00773773|"~     This is a prospective, serum proteomics study of men who are to undergo prostate biopsy. The~     purpose is to determine if proteomic profiles can be used to distinguish between men with~     prostate cancer on biopsy from men with no cancer on biopsy.~   "
212873|NCT00773760|"~     Patients with certain polymorphism in the MOR and COMT genes will display differences in~     their response to analgesics.~   "
212874|NCT00773747|"~     Study of the efficacy and safety of bortezomib administered in combination with vorinostat in~     patients with relapsed or refractory multiple myeloma. Histone deacetylases (HDAC) facilitate~     gene transcription by modulating the uncoiling of chromatin. HDAC function is dysregulated in~     hematologic and solid malignancies, and this dysregulation may result in over-expression of~     oncogenes. Thus, inhibition of HDACs may result in anti-cancer effects. HDAC inhibitors, like~     vorinostat, represent a new class of antitumor agents that have the ability to induce~     antiproliferative effects including cyto-differentiation, cell cycle growth arrest or~     apoptosis in various cancer cell lines. Several studies have investigated the in vitro~     antimyeloma activity of vorinostat in combination with bortezomib and have demonstrated that~     vorinostat may act synergistically with bortezomib to modulate tumor cell growth. Mitsiades~     et al have shown that vorinostat enhances the sensitivity of bortezomib. Pei et al found that~     exposure of human multiple myeloma cell lines & patient-derived multiple myeloma cells to~     bortezomib and vorinostat resulted in synergistic interactions as a result of: (1)~     Interruption of NF-kB & related signaling pathways (JNK, XIAP, Mcl-1, etc.) (2) Inhibition of~     Hsp90 (3)Induction of ER stress signal and (4) acetylation of Dynein/disruption of aggresome~     function/formation, salvage for ubiquitinated proteins. In addition a marked increase in~     mitochondrial injury, caspase activation, and apoptosis was also observed. Bortezomib is~     indicated for the treatment of patients with multiple myeloma. Two Phase I dose-ranging~     studies of a regimen combining vorinostat and bortezomib among patients with relapsed as well~     asend-stage, refractory multiple myeloma have been conducted. These studies enrolled a total~     of 57 patients. In these studies, administration of vorinostat with standard doses of~     bortezomib resulted in responses in 20/45 (44%) evaluable patients (Weber et al 2007, Badros~     et al 2007). The purpose of the present study is to definitively evaluate the clinical~     activity of vorinostat in combination with bortezomib inpatients with multiple myeloma.~   "
212876|NCT00773708|"~     This study aims to provide new knowledge about the pathogenesis of HIV infection,~     specifically, the role that immune activation and apoptotic activity play in immune recovery,~     and in particular, in the paradoxical immunologic response of some patients on antiretroviral~     therapy despite achievement of sustained and complete viral suppression. In this regard, the~     investigators will prospectively evaluate the impact of intensification with Raltegravir in~     those discordants patients with high index of immune activation, measured as the percentage~     of CD8+HLADR+CD38+ cells. This will provide relevant information on the effectiveness of this~     drug in guided intensification regimens.~   "
212877|NCT00773695|"~     This study will evaluate the effect of bevacizumab in combination with chemotherapy or~     endocrine therapy, as preoperative treatment, in participants with HER2 negative breast~     cancer. Participants will be randomized to receive either chemotherapy (FEC100: Epirubicine~     100 milligrams per square meter [mg/m^2], 5-fluorouracil 600 mg/m^2, and cyclophosphamide 600~     mg/m^2] for 12 weeks followed by taxane (paclitaxel/docetaxel) for 12 weeks or endocrine~     therapy (an aromatase inhibitor] daily for 24 weeks) with or without bevacizumab (15~     milligrams per kilogram [mg/kg] as intravenous [IV] infusion every 3 weeks up 24 weeks).~   "
212878|NCT00773682|"~     Objective~      To assess both the short-term and the long term effectiveness of spa therapy in patients with~     primary hand osteoarthritis (OA) in a single blind, prospective controlled, randomized trial.~   "
212879|NCT00773669|"~     The primary goal of this retrospective study is to evaluate the male breast cancer patient~     population at Summa Health System/Akron City Hospital over a period of 18 years and compare~     the findings to historical data.~      The objectives are to:~        -  identify risk factors.~        -  evaluate stage and histology at the time of presentation.~        -  document treatment modalities and outcomes.~        -  analyze outcomes for comparison to historical data.~   "
212880|NCT00773656|"~     Background:~      Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal~     radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among~     them, twenty four patients received an additional mean dose about 20%, due to an~     inappropriate use of the treatment planning system. Severe adverse events (proctitis,~     cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We~     propose to develop several research programs in order to increase the scientific knowledge on~     iatrogenic effects related to overexposure of ionizing radiation, by studying their~     relationship with dosimetric, clinical, biologic and genetic characteristics.~      Aim of the study:~      To correlate the received doses, the volume of irradiated normal tissues, the events, with~     biologic, phenotypic and genetic data.~      Primary study endpoint:~      Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT~     and CTCAE scales).~   "
212881|NCT00773643|"~     The primary objectives of this study are~        -  to procure human temporalis muscle, subcutaneous adipose (fat), and bone tissue samples~          from children with craniosynostosis,~        -  to grow cells from these tissues in vitro,~        -  to evaluate the osteogenic potentials of these cell types.~   "
212882|NCT00773630|"~     The primary objective of this trial is to test whether Pletal ODT administered without water~     can be considered bioequivalent to Pletal administered with 200 ml water (both treatments~     being administered after fasting and at least 30 minutes prior to receiving a light~     breakfast) based on the standard pharmacokinetic variables.~      The secondary objective is to assess the effect of water and the effect of food on the~     administration of Pletal ODT based on standard pharmacokinetic variables.~   "
212883|NCT00773617|"~     This study will compare a new method of treatment for bulimia nervosa (ICAT), integrative~     cognitive-affective therapy, to the current standard method of treatment, cognitive~     behavioral therapy (CBT).~   "
212884|NCT00773604|"~     The purpose of this study is to evaluate the safety and effectiveness of deep brain~     stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.~   "
212885|NCT00773591|"~     This proof-of-concept study is to assess the potential benefit of botulinum toxin for~     patients with sleep-related breathing disorders.~   "
212886|NCT00773578|"~     The allergic respiratory diseases such as asthma or allergic rhinitis are the main chronic~     diseases in children. The airway inflammation plays an important role in their~     pathophysiology. Several epidemiological studies show that environmental tobacco smoke (ETS)~     exacerbates the symptoms of asthma and allergies.~      The aim of this study is to assess the impact of environmental tobacco smoke on the~     measurement of exhaled nitric oxide (eNO) and biomarkers of nasal inflammation in atopic~     asthmatic children.~   "
212887|NCT00773565|"~     The aim of this study is to understand the metabolic changes occurring in fat tissue both~     during controlled weight loss that lead to the improvement of type 2 diabetes and other~     obesity associated metabolic disorders. The novelty of the study is the analysis of~     preadipocytes, a poorly characterized subfraction of the adipose tissue, which provides~     adipocyte precursors and thereby strongly influences adipose tissue mass changes. Knowledge~     of pathways involved in controlling adipose tissue composition will help to design novel~     intervention strategies for the treatment of obesity associated metabolic disorders such as~     type 2 diabetes.~   "
212888|NCT00773552|"~     In this study we hope to establish the prevalence of urinary urge symptoms (with or without~     incontinence) in a multicultural, underserved, hospital clinic population in women between~     the ages of 20 and 45. Quality of life (QOL) in these individuals will be examined. The goal~     is to show a 15% reduction in number of voids in a 24 hour period in our study population~     after 12 weeks of treatment with solifenacin succinate.~      Hypothesis: We believe that urinary urge symptoms are under-reported in young women and~     believe they pose a significant strain on quality of life on otherwise young, healthy~     individuals. Treatment with solifenacin succinate will improve symptoms, in turn improving~     QOL for these individuals.~   "
212899|NCT00773409|"~     The objective of this long term study is to prospectively evaluate the incidence of NSF in~     patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4~     and 5 i.e., with an eGFR below 30)who have not had exposure to a GBCA within 10 years prior~     to enrollment.~   "
212934|NCT00772941|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
212889|NCT00773539|"~     Transvenous pulmonary vein (PV) isolation using radiofrequency energy is an effective~     treatment for atrial fibrillation (1-4). However, rare but potentially life threatening~     complications such as thromboembolism (5), PV stenosis (5-10), left atrium-oesophageal~     fistula (11) and inflammatory syndromes (12) have been described. In preliminary studies an~     alternate approach using cryoenergy induces less endothelial disruption/ thrombus formation~     (13), preserves the extra cellular matrix and creates lesions with well-delineated border~     zones (14). Therefore, cryoenergy seems to be the ideal form of energy to safely perform PV~     isolation.~      We therefore hypothesise that in the setting of PV isolation for the treatment of atrial~     fibrillation (AF) cryoenergy is less traumatic and therefore reduces systemic inflammatory~     responses compared to radiofrequency energy.~      78 patients presenting with symptomatic intermittent or persistent AF will be randomised to~     PV isolation with either radiofrequency (26 patients open irrigated tip, 26 patients closed~     irrigated tip) or cryoenergy (26 patients with cryoballoon). Systemic markers of cell damage~     and inflammatory response (t-troponin, CK, CK-MB, vWF, PAI-1, micro particles, platelet~     activation/overall function, CRP, IL-6, IL-8, IL-10, TNF alpha, procalcitonin) will be~     monitored before, during and 48h after the procedure. Further endpoints include time to~     PV-isolation and procedure related complications. Six month clinical follow-up will focus on~     freedom from AF and cardiovascular events.~   "
212890|NCT00773526|"~     This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1~     of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or~     advanced solid tumors. In the first part of the study, groups of patients will by~     sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The~     starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful~     assessment of the safety and tolerability of the previous dose. In Part 2 of the study,~     patients with selected tumor types will be randomized to receive either the optimal~     biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on~     study treatment is until disease progression, and the target sample size is 100 individuals.~   "
212891|NCT00773513|"~     This 2 arm safety study will compare the outcome with respect to a composite endpoint of~     all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in~     CKD participants either on dialysis or not receiving renal replacement therapy under~     treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will~     be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene~     glycol-epoetin beta at the following doses: for participants not already receiving ESA~     treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose~     of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants~     receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will~     be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on~     the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta~     administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs~     in accordance with their prescribed dosing information.~   "
212892|NCT00773500|"~     Our objective is to determine the effects of electronic prescribing on medication safety~     including medication errors, near misses and preventable adverse drug events in the~     ambulatory setting. Study design will be a longitudinal evaluation of errors early after~     implementation and after sustained use.~   "
212893|NCT00773487|"~     The primary objective of this study is to elucidate the effects of Diesel particles on the~     allergic inflammation in the airways of asthmatic patients.~   "
212894|NCT00773474|"~     A published phase 2 study reported that lonafarnib was administered as a single agent via~     continuous or intermittent oral dosing to 76 women with advanced breast cancer who were~     previously treated with chemotherapy and/or with endocrine therapy. Objective response rates~     of approximately 10% were observed. This study will determine the rate of progression-free~     survival of patients with metastatic breast cancer who receive lonafarnib.~   "
212895|NCT00773461|"~     This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and~     symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with~     active rheumatoid arthritis who currently have an inadequate response to DMARD therapy.~     Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks,~     in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12~     months, and the target sample size is 100-500 individuals.~   "
212896|NCT00773448|"~     Blood clots in leg veins (deep vein thrombosis) or lung arteries (pulmonary embolism) that~     happen for no reason (i.e. unexplained) are both called unprovoked venous thromboembolism~     (VTE). These unexplained blood clots can be the first symptom of cancer. Up to 10% of~     patients with unexplained blood clots will be diagnosed with cancer within one year of their~     blood clot diagnosis.~      These cancers can be found anywhere in the body although the relationship appears stronger~     with the pancreas, ovary and liver. Cancer testing in patients with blood clots is~     controversial. There is presently a wide variety of expert opinions and practices. Previous~     studies showed that a limited cancer screen including a medical history, physical~     examination, basic blood work and chest X-ray, will find about 90% of cancers. More recent~     and better designed studies showed that the limited cancer screen misses many cancers and~     needs to be improved. More extensive cancer testing may find more cancers but is potentially~     uncomfortable for patients, costs a lot of money and involves a lot of people.~      The comprehensive computed tomography is less uncomfortable, inexpensive, radiological test~     made to find many cancers at once. Thus, the scientific question to be asked is: Does a~     comprehensive computed tomography miss less cancers than a limited cancer screen in~     patients with blood clots?~      The main goal of this study is to find out if a comprehensive computed tomography misses~     less cancers than a limited cancer screen in patients with unexplained blood clots.~      The second goal of the study is 1) to find out if a comprehensive computed tomography finds~     more curable cancers than the limited cancer screen; 2) to find out if the patients~     diagnosed with cancer are still alive and cancer-free after one year (i.e. the patients with~     curable cancer were treated and are doing well); 3) to prove that a negative comprehensive~     computed tomography means that the patient will not have cancer and; 4) to find out if a~     comprehensive computed tomography is well tolerated and safe for patients.~   "
212897|NCT00773435|"~     The goal of the this study is to determine if Echinacea purpurea stimulates the immune system~     in children. For the study, 40 healthy children, 6-11 years old will be randomized to receive~     Echinacea purpurea or placebo for 10 days in 3 consecutive months. Blood samples will be~     obtained in the children just before starting study medication, during the first course of~     medication and either just prior to starting the second course of medication or 50 days~     following the last of the three courses of medication. Markers of immune activity in children~     receiving Echinacea or placebo will be compared.~   "
212898|NCT00773422|"~     The purpose of this study is to examine how medications thought to attenuate the effects of~     alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to~     resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming~     drink, in non-treatment seeking alcohol-drinking daily smokers.~   "
212900|NCT00773383|"~     This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive~     disease after deriving clinical benefit (defined as response or stable disease after 12~     weeks) from second or third line Tarceva monotherapy will determine the proportion of~     patients with progression-free survival at 12 weeks following combination therapy with R1507~     and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva~     (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints~     including overall survival, objective response rate, time to response, time to progressive~     disease and duration of response will also be evaluated. The anticipated time on study~     treatment is 1-2 years, and the target sample size is <100 individuals.~   "
212901|NCT00773370|"~     This study will compare the Adaptive Physical Activity program (APA) to a less vigorous group~     exercise program, (Sittercise) to see if APA leads to greater improvements in walking~     endurance, quality of life, and participation in social activities.~   "
212902|NCT00773357|"~     The purpose of this study is to examine whether guanfacine or carvedilol will attenuate the~     ability of stress to precipitate smoking lapse behavior in treatment seeking and~     non-treatment seeking daily smokers. Participants seeking treatment for smoking will~     participate in a smoking cessation attempt after the laboratory sessions. Also looking at~     gender differences.~   "
212903|NCT00773344|"~     The primary purpose(s) of this study is to determine the highest tolerated dose of~     tanespimycin and to determine anti-tumor activity (via objective response rate) of~     tanespimycin in patients with breast cancer who have not previously responded to Herceptin~   "
212904|NCT00773331|"~     This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability~     of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis~     patients with chronic renal anemia. Patients will be randomized to receive either~     subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous~     epoetin beta in accordance with the prescribed dosing information. In both groups, the~     starting dose will be the same as the previous dose of epoetin beta administered in the week~     preceding first study drug administration. Patients will be treated for 28 weeks with follow~     up 4 weeks after the last treatment visit. The anticipated time on study treatment is 3-12~     months, and the target sample size is 100-500 individuals.~   "
212905|NCT00773318|"~     Nodal staging is a key-step in pre-treatment assessment of prostate cancer. In patients with~     a low probability of nodal metastasis, bilateral pelvic lymphadenectomy is controversial. The~     large majority of them (> 80%) are free of nodal disease in obturator and external iliac~     stations. On the other hand, skip metastases located outside the standard lymphadenectomy may~     be missed, particularly in more proximal nodal stations (i.e. common iliac nodes and~     pre-sacral nodes).~      In prostate cancer, growing data indicate the potential utility of LM/SL, particularly in~     patients with a low pre-test probability of nodal disease. However, very few data have been~     reported on the feasibility and the utility of SPECT/CT following LM/SL. In a pilot study~     including 11 patients with prostate cancer, Kizu and colleagues used a software image fusion~     from separate SPECT and CT studies. These authors concluded to the utility of image fusion to~     localize anatomically the SLNs. They also suggested the use of hardware fusion from a single~     gantry SPECT/CT device for accurate detection of SLNs. Accordingly, Corvin and colleagues~     recently reported the suitability of sentinel node detection in a series of 28 patients with~     prostate cancer; in this study, an integrated single slice SPECT/CT device was used to~     localize the SLNs.~      In the light of the encouraging data from literature and our own preliminary clinical~     experience, we hypothesized that the use of integrated SPECT/low-dose multislice CT guided~     LM/SL may be of clinical interest in patients with prostate cancer.~   "
212906|NCT00773305|"~     The primary goal of this project is to evaluate the efficacy of prostate seed implantation~     for the treatment of early stage prostate cancer for patients treated at Summa Health~     System/Akron City Hospital and Salem Community Hospital.~   "
212907|NCT00773292|"~     HAM/TSP is a chronic disease of the spinal cord, caused by a virus called HTLV−I. Worldwide~     approximately 20 million persons are infected.Infection with HTLV−I is lifelong, and about 3%~     of infected persons will develop this chronic debilitating disease, of which half will become~     wheelchair dependent. We, and others, have shown a strong and persistent immune response to~     HTLV−I in carriers and patients with HAM/TSP, but this fails to clear the virus. However,~     carriers with a low burden of virus in the blood have a low risk of developing disease. The~     immune response in these carriers seems better able to kill infected cells. A less efficient~     response is associated with a higher viral burden that drives the immune response with a~     resultant release of chemicals by the immune cells that inadvertently cause harm, most~     especially to cells in the spinal cord. Our understanding of HAM/TSP suggests that targeting~     the immune response should improve the health of our patients especially if the disease is~     diagnosed early. To identify the best type of treatment we are planning a series of studies~     of drugs that target the immune response in different ways. Each has been used in other~     inflammatory conditions but never before studied in HAM/TSP. We aim to study the extent and~     duration of the clinical response and to associate this with the different effects that the~     therapies have on the immune response and on the number of HTLV−I infected cells in the~     blood. This in turn will improve our knowledge and understanding of the disease and should~     lead to better therapy. This application is in relation to the first study − to explore that~     therapeutic benefit of ciclosporin in patients with HAM/TSP.~   "
212908|NCT00773279|"~     This trial is conducted in the United States of America (USA). The aim of this clinical trial~     is to assess and compare the effect on blood sugar control of insulin detemir and insulin~     aspart or insulin detemir alone administered by a insulin pen PDS290 (FlexTouch®) versus a~     Novo Nordisk marketed insulin pen (FlexPen®) in subjects with type 1 or type 2 diabetes~     mellitus. Furthermore, the subject's preference of the devices will be investigated by the~     use of questionnaires.~   "
212909|NCT00773266|"~     The purpose of this study is to evaluate the intraocular stability and safety of secondary~     iris-fixated IOLs in aphakic patients.~   "
212932|NCT00772967|"~     This study will evaluate a walking model of osteoarthritis for use in testing of new~     therapeutic agents. The primary hypothesis is that participants treated with Naproxen or~     Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during~     self-paced walks on Day 3 of treatment.~   "
212910|NCT00773253|"~     The purpose of this study is to determine how to improve treatment of patients with cervical~     dystonia who have not been helped with standard Botox injections. This study is for patients~     with cervical dystonia who have not benefited from treatment with Botox using conventional~     single lead electromyographic (EMG) techniques for injection. The study aim is to see if~     these patients may have significantly more benefit if their Botox is injected into muscles~     that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox~     injection.~   "
212911|NCT00773240|"~     The study assess the pharmacodynamic effect and the tolerability of Grazax treatment~     initiated in the grass pollen season in subjects with seasonal grass pollen induced~     rhinoconjunctivitis~   "
212912|NCT00773227|"~     The OCULO-Pharyngeal Muscular Dystrophy (OPMD) is a late onset hereditary muscle disease~     which is characterised by the selective affection of the pharyngeal muscles resulting in~     swallowing disorders, and by a ptosis from the dysfunction of the levator palpebral superiors~     muscles. Swallowing disorders are determinant in the prognosis of the disease, and~     potentially life-threatening deglutition, due to aspiration and denutrition. Degenerative~     dystrophy of the pharyngeal muscles causes difficulties to prepulse the food bolus in the~     pharynx, and the decreased relaxation of the cricopharyngeal muscle induced by the disease~     leads to blockage of food in the upper esophageal sphincter. The most common treatment for~     the dysphagia in OPMD is a myotomy of the upper esophageal sphincter muscles. However,~     although this will relax the constriction of the upper esophageal sphincter muscles and~     improve transitory the swallowing, it will not prevent the progressive degradation of the~     pharyngeal muscles. This progressive loss of contractility will eventually result in~     aspiration and severe difficulty in swallowing, increasing risk of aspiration pneumonia and~     severe weight loss which are the most common causes of mortality in OPMD patients.~      The protocol which we are proposing is a graft of autologous cell muscles (myoblasts)~     isolated from unaffected limb muscles into the pharyngeal muscles of patients diagnosed as~     suffering from OPMD. Our aim is to improve both swallowing and the contractile deficit~     generated by the dystrophic pharyngeal muscles. A myotomy of the upper esophageal sphincter~     will be carried out at the same time as the myoblast transplantation, since we have already~     validated the improvement resulting from this surgery. Advantages of this new therapy in OPMD~     is the autograft, without risks of rejection, and the graft of myoblasts into the dystrophic~     pharyngeal muscles, above the myotomy of the upper esophageal sphincter muscles.~      This model of cellular therapy has been studied through a preclinical study performed in~     dogs, allowing to valid the procedure and its safety, as well as to study the survival~     myoblasts grafted in the pharyngeal muscles.~      This protocol is proposed for OPMD patients; it is firstly a safety study of both autograft~     and surgical procedure. In addition, the autograft may improve the swallowing disorders and~     life-threatening complications induced by aspiration and weight loss, resulting in a~     potential individual benefit.~   "
212913|NCT00773214|"~     The identification and characterization of individuals who vary in their response to~     exercise-induced weight loss is important. Weight loss in response to exercise is variable~     and it remains unknown who will succeed, why, and more importantly how to improve weight loss~     efficacy.~      This study will examine changes in behavioural, metabolic, physiological and biochemical~     variables in response to a 12 week supervised exercise programme and evaluate their~     association with weight loss in overweight and obese sedentary individuals.~      Our hypothesis is that changes in the plasma levels of appetite related hormones undermine~     the inter individual variation in weight loss in response to exercise.~      This study will improve the understanding of variability to exercise-induced weight loss and~     allow more individually tailored and appropriate strategies for weight management programmes.~   "
212914|NCT00773201|"~     The main objective is to research for genetic factors involved in the extreme modifications~     of the QT interval of the electrocardiogram in answer to a pharmacological stimulation~     (sotalol) and physiological stimulation in the apparently normal general population.~      The phenotypic characterization, based on the ventricular repolarisation dynamics will be~     used aiming at term of the predictive genetic factors of the acquired long QT syndrome~   "
212915|NCT00773188|"~     This single arm study will assess the feasibility of use, safety and tolerability of~     Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally~     advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients~     will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic~     radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv~     administered according to a standard treatment protocol). If no dose-limiting toxicities are~     observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3~     weeks, in combination with a similar treatment regimen to that of the first cohort. After 5~     cycles of combination treatment, Avastin monotherapy will be administered for a further 4~     cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is~     <100 individuals.~   "
212916|NCT00773175|"~     Randomized (1:1 ratio) study of SC versus IV fluid rehydration in mildly to moderately~     dehydrated pediatric patients.~   "
212917|NCT00773162|"~     To add to our understanding of the relationship between blushing, symptom severity and~     potential mechanisms that underlie blushing in patients with Social Phobia (SP), the~     investigators propose comparing SP patients' vascular responses to topical m-N pre and post~     treatment with Seroquel or placebo.~      Atypical antipsychotics such as seroquel have been used successfully as adjunctive treatments~     in other anxiety disorders, including PTSD (Labatte, 2001; Krashin & Oates, 1999; McDougle et~     al., 2000; Pfanner et al., 2000; Bogetto et al., 2000) and Generalized Anxiety Disorder~     (Katzman et al., 2005). Responses to the blushing exposure will be assessed prior to and~     following treatment with seroquel or placebo and at one month following intervention. Levels~     of prostaglandin will be compared between groups and will also be correlated with symptom~     severity in the clinical groups.~      The objective of this randomized, double blind flexible -dose study will be to evaluate the~     efficacy , safety and tolerability of seroquel SR 50mg to 800mg and placebo in outpatient~     subjects diagnosed with SP. The study will begin with a single week of Seroquel 50mg or~     placebo. Subsequently, tablets will be administered by the investigator in a flexible dose~     fashion during the visits. Patients will be followed up weekly (biweekly after week 6) and at~     the clinician's discretion. After the fist week the patients' dosage will be increased up to~     a maximum of 800 mg daily with expected average dose of 300mg dail. This dose will remain~     fixed after 8 weeks of treatment until week 16.~   "
212918|NCT00773149|"~     Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface~     of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells.~     Adult patients with ALL in relapse have less than 10% probability of long term survival. The~     present study will test the response rate (partial and complete remission) of refractory ALL~     or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be~     given for a hematopoietic stem cell transplant.~      The use of G-CSF is justified by a possible increase in ADCC.~   "
212933|NCT00772954|"~     This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess~     the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine.~     Population: healthy male and female adults, 18 to 55 years old.~   "
212986|NCT00772265|"~     The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard~     to its total and to its maximum serum insulin concentrations.~   "
212919|NCT00773136|"~     Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in~     gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the~     Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled.~     Each participant received two vials of gel suspension, which contained bimatoprost and normal~     saline, respectively, each mixed 1:1 with GonakTM gel and labeled right eye and left eye~     according to randomization. The suspension was applied to the eyelashes every evening on the~     designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly~     intervals during the study and at 1 and 3 months after study completion. Visual acuity,~     ocular symptoms, intraocular pressure and photographs were documented at these same~     intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control~     average of 1.13mm) which was a statistically significant difference (p=0.009). The average~     intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity~     or iris discoloration was noted in any of the subjects. Discussion: Our data showed an~     increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have~     eyelash lengthening properties.~   "
212920|NCT00773123|"~     RT-View utilizes spectral domain technology to assess both RNFL and ganglion cell layer~     thickness. This study aims to correlate visual field defects in patients with glaucoma to~     both RNFL and ganglion cell layer thickness.~   "
212921|NCT00773110|"~     The purpose of this study is to determine whether albumin administration during cardiac~     surgery is effective in attenuating the development of inflammation following surgery.~   "
212922|NCT00773097|"~     The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an~     investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons~     with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 -~     poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and~     to prevent polyps from recurring.~      MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is~     expressed in a larger amount and in a modified form on adenomatous polyps and colorectal~     cancer. These changes in MUC1 are thought to be part of the process of progression from~     adenomas toward cancer. The goal of a vaccine is to help the immune system in the body~     identify the changes in MUC1 that accompany the progression to cancer and eliminate the~     abnormal cells that make abnormal MUC1.~   "
212923|NCT00773084|"~     This study is being conducted to compare the effects that 2 different combinations of heart~     failure medications have on the levels of certain blood markers which cause and/or worsen~     heart failure. Additionally, the investigators will investigate any differences that may~     exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic~     Americans will have a greater response to this new regimen compared to non-Hispanic~     Americans.~   "
212924|NCT00773071|"~     Nodal staging is a key-step in pre-treatment assessment of gynecological cancers. In recent~     years, lymphatic mapping and sentinel lymphadenectomy (LM/SL) as a minimally invasive pelvic~     lymph nodes staging has been successfully evaluated in women with early stage of vulvar~     cancer, cervical cancer, and endometrial cancer. Such a technique may offer several valuable~     advantages: a) it is readily applicable in clinical routine using a safe, inexpensive, and~     reproducible protocol; b) it may help to avoid the cost and the morbidity of unnecessary~     lymphadenectomy in the majority of cases with uninvolved sentinel lymph nodes; c) it has the~     potential to guide the surgeon to nodal regions that are not routinely dissected (i.e.~     pre-sacral, para-aortic nodes) and to identify micro-metastases that would have been ignored~     otherwise; d) it also offers the basis for sophisticated pathological analysis to detect~     sub-microscopic nodal metastases using either immunohistochemical or molecular biological~     techniques.~      So far, within the abdomen and the pelvis, the LM/SL technique alone is often blinded to the~     accurate localization of SLNs. The integration of computed tomography (CT) to single photon~     emission computed tomography (SPECT) devices in a single gantry (SPECT/CT) has allowed a~     significant gain in terms of diagnostic accuracy and anatomic precision; clinical examples~     include malignant melanoma, head and neck cancer, breast cancer, and bladder cancer. In a~     seminal series of 26 patients with cervical cancer (Zhang et al., 2006), SPECT/CT was~     recently found superior to conventional planar imaging for detection of SLN and accurate~     localization. A more recent study (Kushner al., 2007) has also highlighted the technical~     feasibility and the clinical added-value of a low-dose SPECT/CT in a series of 20 patients~     with early stage cervical cancer (IA2-IIA) who underwent LM/SL.~      In the light of the encouraging data from literature and our own preliminary clinical~     experience, we hypothesized that the use of LM/SL plus SPECT/CT may be of clinical interest~     in patients with gynecological cancers.~   "
212925|NCT00773058|"~     The purpose of this study is to see if stress doses of hydrocortisone improve early outcome~     in patients who are in early stage of ARDS and with relative adrenal insufficiency.~   "
212926|NCT00773045|"~     The purpose of this study is to evaluate the effect of a pain training program and systematic~     measurement of pain scores on actual pain levels and the use of analgesics in critically ill~     patients.~   "
212927|NCT00773032|"~     The purpose of this study is to investigate whether~        1. pharmacologically enhanced naps will show increases in specific sleep stages~        2. whether these sleep stages will produces specific increases on memory tests~        3. whether older adults will benefit more than young adults from increased SWS or Stage 2~          on subsequent declarative and motor memory tests.~   "
212928|NCT00773019|"~     This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers.~     Subjects are selected from those evaluated and planning to receive a SynchroMed II drug~     infusion system for treatment of severe spasticity or chronic pain. Subjects must return for~     refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically~     necessary refills. Information is collected on all refills and adverse events.~   "
212929|NCT00773006|"~     Advances in mechanical intervention (PCI) and anticoagulation therapy have been the~     cornerstone of treatment of patients with coronary artery disease. However, the large~     diversity of approaches to anticoagulation during PCI introduces gaps in knowledge regarding~     management of cardiac patients. As such, we have initiated a national PCI registry to~     elucidate anticoagulant choice, dosing strategies, case selection dynamics, and clinical~     outcomes in the Canadian health care environment.~   "
212930|NCT00772993|"~     Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This~     assumption has led to the monitoring of the retinal nerve fiber layer thickness for the~     diagnosis and monitoring of progression of glaucoma. However, varying disc size, myopia and~     tilted discs affect the thickness of the retinal nerve fiber layer. This study aims to~     ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of~     glaucoma diagnosis and progression.~   "
212931|NCT00772980|"~     The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in~     the treatment of subjective tinnitus in comparison to placebo.~   "
212935|NCT00772928|"~     This study is designed to evaluate in a controlled manner the effect of Prevnar® on the~     immune responses of Pentacel™~      Primary Objective - Stage I:~      To compare the immune responses elicited by an infant series of Pentacel™ when given at~     different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).~      Primary Objective - Stage II:~      To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different~     times from or concurrently with Prevnar®.~   "
212936|NCT00772915|"~     RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking~     blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well lenalidomide works with or without~     dexamethasone in treating patients with newly diagnosed multiple myeloma.~   "
212937|NCT00772902|"~     This study investigated whether human immunodeficiency virus type 1 (HIV-1) infected subjects~     with raised cholesterol switching their nucleoside reverse transcriptase inhibitor (NRTI)~     backbone from Kivexa (Epzicom) to Truvada had an improvement in their fasting total~     cholesterol after 12 weeks of treatment. The study also investigated whether any improvement~     had a beneficial effect on the overall cardiovascular risk.~   "
212938|NCT00772889|"~     The purpose of this observer-blind clinical trial is to evaluate the safety and~     immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly.~     Subjects were previously vaccinated (NCT00529516).~   "
212939|NCT00772876|"~     This is a phase I study of a novel compound P1446A-05. Aim of this study is to identify the~     the recommended phase II dose of the drug and to determine the nature of adverse effects~     associated with the drug. P1446A-05 capsules will be given continuously (28 days in each 28~     day cycle) to patients suffering from advanced malignancies with no effective treatment~     available. The dose of the study agent will be lower i.e. 75 mg per day for initial patients.~     If this dose is found safe, higher dose will be administered to next set of (three to six)~     patients. This will continued till the safest and best dose is identified. Treatment will be~     given for 4 cycles and continued further if found effective. Dose schedule may be modified to~     introduce treatment holiday,if frequent adverse effects are seen on continuous~     administration.~   "
212940|NCT00772863|"~     The purpose of this study is to assess the efficacy and the safety of the treatment.~   "
212941|NCT00772850|"~     The purpose of this study is to investigate the potential insults of rotator cuff muscle and~     the functional recovery of upper extremity function after antegrade nailing of humeral~     fractures.~   "
212942|NCT00772837|"~     Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer~     dyspepsia remain controversial . Many studies have examined the effect of H. pylori~     eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive,~     with as many studies yielding positive as negative results. Some studies have shown a~     significant (although weak) symptomatic improvement after H. pylori eradication, and while~     other yielding negative results. A recent Cochrane review has comprehensively demonstrated~     that H.pylori eradication therapy has a small but statistically significant effect in~     H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may~     still be cost effective . However it is difficult to reconcile these results in areas with~     very high prevalence of H. pylori infection such as Pakistan since no such studies have been~     conducted in developing countries.~      The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a~     sustained improvement in symptoms of patients diagnosed with H. pylori associated functional~     (non-ulcer) dyspepsia.~   "
212943|NCT00772824|"~     Glutamine, a non essential branched chain amino acid, is most important non toxic nitrogen~     carrier in body. It participates in variety of physiological functions. It is a major fuel~     source of enterocytes and is a substrate for gluconeogenesis in kidney, lymphocytes, and~     monocytes. It is also a nutrient in muscle protein metabolism in response to infection,~     inflammation and muscle trauma. The significance of glutamine to metabolic homeostasis~     becomes evident during periods of stress, when it becomes a conditionally essential amino~     acid. Role of glutamine as protective agent in hepato-biliary dysfunction, in maintaining~     mucosal integrity of the Gastrointestinal tract following its administration in patient with~     major bowel surgery as a supplement and part of TPN in critically ill patients and in~     patients of septicemia, is well established. However the role of glutamine supplementation in~     reducing or preventing chemotherapeutic agents induced toxicity in cancer patients is~     controversial.~   "
212944|NCT00772811|"~     Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan~     Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma~   "
212945|NCT00772798|"~     TITLE:A Phase II non-comparative study of paclitaxel plus carboplatin in combination with~     Vorinostat in patients with advanced, recurrent epithelial ovarian cancer.~     INDICATION:Second-line treatment of patients with recurrent platinum-sensitive epithelial~     ovarian cancer. RATIONALE:Recurrent epithelial ovarian cancer is today an incurable disease.~     The current standard of care consists of systemic chemotherapy using either carboplatin plus~     paclitaxel (in platinum-sensitive patients) or single agent chemotherapy with agents like~     liposomal doxorubicin, topotecan, weekly paclitaxel or gemcitabine (platinum non-sensitive~     patients). The outcome for patients with advanced ovarian cancer nevertheless remains~     poor.Preclinical evidence suggests that vorinostat, a potent histone deacetylase (HDAC)~     inhibitor, may potentiate the antitumor activity of paclitaxel and/or carboplatin. The study~     will assess whether the addition of vorinostat to paclitaxel plus carboplatin is manageable~     and induces reasonable response rates in patients with advanced recurrent, platinum-sensitive~     ovarian cancer. Biomarkers will be collected from both primary tumors and biopsies before and~     after start of treatment with vorinostat.~      DESIGN:Phase II, single-center study. All eligible patients will be treated with intravenous~     paclitaxel plus carboplatin plus oral vorinostat. Patients will be treated with a maximum of~     6 cycles or until disease progression, unacceptable toxicity or withdrawal of consent.~     Clinical endpoints will include adverse experiences, progression-free survival (PFS) and~     response rate (RR). SAMPLE:Patients must have a histologically confirmed diagnosis of~     epithelial ovarian cancer, cancer of the Fallopian tube or primary peritoneal adenocarcinoma.~     All patients will have received first-line therapy with carboplatin plus paclitaxel. Patients~     should be platinum sensitive, defined as recurrence or progression of ovarian cancer, cancer~     of the Fallopian tubes or primary peritoneal adenocarcinoma 6 months or later after the end~     of first-line chemotherapy. Patients to be enrolled on this study must have acceptable~     performance status and acceptable renal and hepatic function, and be free of other serious~     intercurrent illness that could impair their ability to receive protocol therapy. The study~     will include up to 55 assessable patients, of which 20 will provide biomarkers. It is~     estimated that the inclusion period will last approximately 24 months. DOSAGE/DOSAGE FORM,~     ROUTE, AND DOSE REGIMEN Eligible patients will be treated with paclitaxel (175 mg/m2) and~     carboplatin AUC5 administered by intravenous infusion (IV) on day 1 of each treatment cycle.~     In addition, all eligible patients will receive treatment with oral vorinostat (400 mg)~     administered once daily by mouth with food on days -4 through 10 of Cycle 1 (25-day treatment~     cycle) and days 1 through 14 of each subsequent 21-day treatment cycle. Patients will receive~     antiemetic therapy according to institutional guidelines as well as premedication with~     dexamethasone, and antihistamines (an H1-receptor antagonist and an H2-receptor antagonist)~     for prevention of the side effects of paclitaxel.~   "
213116|NCT00770562|"~     This study will compare the efficacy, safety, and pharmacokinetics of standard treatment~     versus standard treatment plus MabThera in patients with ITP. The anticipated time on study~     treatment is <3 months, and the target sample size is 100-500 individuals.~   "
212946|NCT00772785|"~     Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral~     tablets, patients experience withdrawal and cravings when the variable BPN levels in the~     blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin~     that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study~     will test the safety and efficacy of Probuphine in the treatment of patients with opioid~     dependence. Patients who have completed at least 24 weeks of treatment in the Open-Label,~     Multi-Center Study of Probuphine in Patients with Opioid Dependence (PRO-807 Study), will be~     re-treated with Probuphine over an additional 24 weeks.~   "
212947|NCT00772772|"~     The reason for doing this research is that people with kidney disease often suffer from heart~     disease. Why this happens is not fully known. A possible cause may be high blood levels of a~     substance made by bacteria called endotoxin. The blood levels of this substance are high in~     people with medium-level kidney disease.~      We want to know if replacing normal amounts of Vitamin D can help lower the levels of this~     substance. We also want to know if replacing normal amounts of Vitamin D is associated with~     other changes that may help heart disease. We hope that our research will help figure out if~     levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal~     subjects are enrolled to have a 'control' set for comparison purposes.~   "
212948|NCT00772759|"~     The primary objective of the study is to investigate the safety and tolerability of single~     and multiple once daily ascending doses of AZD3199 delivered as dry powder via the Turbuhaler~     inhaler in healthy male Japanese subjects by assessment of incidence and nature of adverse~     events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP),~     pulse rate, lung function parameters, body temperature and laboratory variables (clinical~     chemistry, haematology and urinalysis). The secondary objectives of the study are to~     investigate the pharmacokinetics (PK) of single and multiple ascending doses of AZD3199 by~     assessment of the degree of accumulation, dose proportionality and time linearity in healthy~     Japanese subjects, and to investigate systemic β 2- adrenoreceptor mediated effects of single~     and multiple ascending doses of AZD3199 by assessment of potassium and lactate~     concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure and~     FEV1.~   "
212949|NCT00772746|"~     The investigators hypothesized that the group of patients receiving the medication~     interventions and CBT would show significant changes in their behavior, such as remission or~     reduction in anxiety, panic attacks, anticipatory anxiety, fear of body sensations, loss of~     control, and agoraphobia avoidance. And also, in the general evaluation of well-being, in the~     beginning and end of the treatment, in comparison to the control group (medication without~     CBT), during the same period.~   "
212950|NCT00772733|"~     The purpose of this study is to ensure the quality of the COPD treatment in primary care by~     implementing planned follow-up visits, where the disease condition is evaluated and optimised~     in accordance with the national COPD recommendations. If relevant the general practitioner~     (GP) will refer patients to COPD rehabilitation conducted by relevant municipality~     rehabilitation teams. Secondarily the purpose is to improve collaboration and communication~     between the local hospital pulmonologist, GPs and the municipality rehabilitation team~   "
212951|NCT00772720|"~     Raltegravir is the first of a new antiretroviral class. A better profile of metabolic~     toxicity is expected. In order to better define its effects, without interference with other~     drugs, a study on healthy volunteers is warranted.~   "
212952|NCT00772707|"~     The purpose of this study was to demonstrate that current successful fulltime daily wear soft~     contact lens wearers using competitive multi-purpose solutions will note improved comfort~     when using OPTI-FREE RepleniSH®.~   "
212953|NCT00772694|"~     Germ cell tumors, a relatively rare disease, but most common malignancy in young males, occur~     most frequently in testis. The incidence is about 1%, but is increasing in the majority of~     developed countries. The testicular cancer is an extremely important oncological condition~     due to his high rate of 80-90% of curability, which can be achieved by combination of~     chemotherapy and surgery.~      Some of 20-30% of patients will experience disease progression after first line~     cisplatin-based chemotherapy and salvage 2nd line conventional-dose cisplatin-based salvage~     chemotherapy will result in long term remissions in < 50% of patients (VeIP - vinblastine,~     ifosfamide, cisplatin, VIP/PEI - ifosfamide, etoposide, cisplatin, TIP - paclitaxel,~     ifosfamide, cisplatin). In multiple relapsed patients the 3rd line chemotherapy can induce~     remission in up to 40% (gemcitabine, oxaliplatin), 23% RR (TG - paclitaxel, gemcitabine), 20%~     CR (IPO - irinotecan, paclitaxel, oxaliplatin), but only small proportion of them can be~     cured, usually with subsequent consolidation surgery. At that stage the disease is usually~     chemorefractory and there are no other chemotherapy regimens of proven benefit (7).~      The purpose of this study is to determine if multiple-relapsed chemorefractory pts may~     benefit from sorafenib monotherapy.~   "
212954|NCT00772681|"~     -  To assess the efficacy of docetaxel, cisplatin combination in terms of disease free~          survival.~        -  Time to progression of the disease in terms of local and distant failure; assess the~          survival time, and assess the objective (clinical and radiological) response rate and~          the safety of the treatment.~   "
212955|NCT00772668|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking~     blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and~     prednisone may kill more cancer cells.~      PURPOSE: This clinical trial is studying how well giving rituximab together with~     cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients~     with stage III or stage IV follicular lymphoma or marginal zone lymphoma.~   "
212956|NCT00772655|"~     This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab~     Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade~     I-IIIa and stage III-IV (as well as for selected patients with extended abdominal stage II).~     For patients with complete clinical remission but persistent molecular disease subsequent to~     90Y-Ibritumomab Tiuxetan treatment a consolidation immunotherapy with Rituximab is added, to~     eradicate minimal residual disease.~   "
212957|NCT00772642|"~     This study, conducted by the Malaria Research and Training Center at the University of~     Bamako, Mali, and the NIAID, will examine how exposure to the malaria parasite in the womb~     affects the developing immune system of newborns. Little is known about how such exposure in~     the womb may affect the immune system or alter the risk of malaria or responsiveness to~     vaccination after birth. A better understanding of this process may provide information~     useful for childhood vaccination strategies in areas where malaria is widespread.~      Women 18 years of age and older who live in Bancoumana and are in their last trimester of~     pregnancy and in good health may be eligible for this study.~      Participants have blood samples drawn from a finger stick and through a needle placed in a~     vein two times for this study: when they enroll in the study and again when they go to the~     Bancoumana Health Center to deliver their baby. After the baby and placenta are delivered,~     blood is collected from the umbilical cord and placenta.~   "
212958|NCT00772629|"~     This study was designed to generate data for the assessment of Meningococcal Polysaccharide~     Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years.~      Primary Objective:~      To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the~     administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria~     Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby~     rabbit complement (SBA BR) in participants in each of the two study groups.~      Secondary Objective:~      To collect reference sera for the development and refinement of laboratory assays for the~     measurement of antibody responses to serogroups Y and W 135.~   "
212959|NCT00772616|"~     Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative~     hyperalgesia. We have developed two automated bispectral index - guided drug delivery~     systems: one for propofol administration, the other for combined propofol and remifentanil~     administration. Both systems achieve the same objective: similar level of anesthesia~     indicated by bispectral index levels between 40 to 60. We make the assumption that this~     method of automated remifentanil administration may avoid postoperative hyperalgesia.~     Patients scheduled for abdominal surgery will be divided into two groups:~        -  in one group, patients will receive automatically delivered propofol and manually~          delivered sufentanil according to the usual criteria,~        -  in the other group, patients will receive propofol and remifentanil both automatically~          administered.~      Assessment of postoperative hyperalgesia will be primarily based on morphine consumption~     (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.~   "
212960|NCT00772603|"~     Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults~     with partial onset seizures~   "
212961|NCT00772590|"~     A research study to measure the effect on CD4 counts of adding to current anti-retroviral~     regimen raltegravir with or without hyper-immune bovine colostrum.~   "
212962|NCT00772577|"~     Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril~     in Obese patients (BMI ≥ 30) with Stage 2 Hypertension~   "
212963|NCT00772564|"~     The administration of high dose HMG-CoA reductase inhibitors (Statins) to patients with acute~     ST-elevation MI (hypoxia/ischemia) who are treated with primary PCI (reoxygenation/~     reperfusion) will protect their cardiomyocytes from death and thus preserve LV ejection~     fraction.~   "
212964|NCT00772551|"~     Evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when~     co-administered to male and female healthy volunteers.~   "
212965|NCT00772538|"~     The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate~     the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to~     placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined~     as add-on controller therapy on top of usual care in patients with severe persistent asthma.~      The primary objective of each trial is to evaluate the long term efficacy of tiotropium over~     placebo on top of usual care in patients with severe persistent asthma as determined by~     pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on~     asthma control and health care resource utilisation. The secondary objective of each trial is~     to compare the long term safety of tiotropium with placebo in this patient population.~   "
212966|NCT00772525|"~     The primary objective of the study was to evaluate the effect of Nerispirdine (50 mg or 400~     mg) and placebo given orally as a single dose once a week in crossover design on latency of~     Visual Evoked Potentials (VEP) P100 in optic nerves.~      Secondary objectives included evaluation of the effect of Nerispirdine on VEP amplitude and~     other visual parameters including visual acuity and contrast, as well as evaluation of the~     safety and tolerability of Nerispirdine in patients with Multiple Sclerosis (MS).~      Contrast sensitivity and visual acuity examinations (in addition to Optical Coherence~     Tomography [OCT] and VEPs) were needed during the screening period for defining etiologic~     relationships (if non-MS related impairment) and for assessing the effect of treatment of~     age-related eye disease versus the MS-related vision impairment.~   "
212967|NCT00772512|"~     The purpose of this study is to determine if PF-04802540 decreases REM sleep.~   "
212968|NCT00772499|"~     The purpose of this study is to compare in patients with primary hypertension, the non-blood~     pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol~     on changes in the vascular structure and function.~   "
212969|NCT00772486|"~     The study is a Phase 1b open label, non-randomized, single institution clinical trial that is~     designed to evaluate the safety and tolerability of three repeat infusions of ISF35 followed~     by a standard regimen of three cycles of fludarabine, cyclophosphamide and rituximab (FCR) in~     subjects with refractory, resistant, and/or 17p- CLL.~   "
212970|NCT00772473|"~     To assess CGRP levels in saliva through the evolution of migraine.~   "
212971|NCT00772460|"~     Two patient warming systems will be compared with 40 patients each in a convective warming~     group (BairHugger, Arizant) and in a conductive warming group (HotDog, Augustine Biomedical).~      The patients will undergo small to medium trauma surgery and will be warmed with the~     randomized device - the hypothesis is, that the area under the standardized core temperature~     / time curve is significantly greater in the conductive warming group. Secondary outcome is~     the mean skin temperature / time area under the curve.~   "
213654|NCT00763321|"~     The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of~     ABT-712, compared to placebo, administered over a 4-week period in participants with moderate~     to severe mechanical chronic low back pain (CLBP).~   "
212972|NCT00772447|"~     The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin~     (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by~     Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated~     Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.~   "
212973|NCT00772434|"~     A wide variety of individuals are at risk for bleeding, but even though bleeding symptoms are~     common it is difficult to compare different people's symptoms. Recent research has found that~     carefully designed surveys can be used to calculate a bleeding score that is useful for~     diagnosing bleeding disorders, but normal individuals have not been specifically studied in~     large numbers with a comprehensive survey. Whether factors like race, ethnicity, age, sex,~     aspirin use, and previous trauma and surgery influence bleeding scores is also unknown. The~     primary goal of this study is to use a comprehensive computerized questionnaire to record the~     bleeding symptoms of normal individuals and then assess the range and severity of bleeding~     symptoms in this normal population.~      Secondary goals include determining whether race, ethnicity, age, sex, aspirin use, and~     previous trauma and surgery correlate with bleeding symptoms.~   "
212974|NCT00772421|"~     The primary objective is to demonstrate that a higher proportion of responders to deep brain~     stimulation (DBS) in the anterior nucleus (AN) of the thalamus in refractory epilepsy~     patients in the SANTE study exhibit a recruitment rhythm relative to non-responders.~   "
212975|NCT00772408|"~     Infection with Mycobacterium tuberculosis remains at epidemic levels globally. Innate and~     adaptive immune responses evolve as protective mechanisms against mycobacterial infection in~     humans. Toll-like receptors (TLRs) are transmembrane proteins characterized by an~     extracellular leucine-rich domain that participates in ligand recognition and an~     intracellular tail. TLRs are the first defense system to detect potential pathogens, initiate~     immune responses and form the crucial link between innate and adaptive immune systems.~     Stimulation of TLR initiates a signaling cascade that involves a number of proteins, such as~     MyD88 and IL-1 receptor-associated kinase. This signal cascade leads to NF-κB activation,~     which induce the secretion of pro-inflammatory cytokines.~      TLR2 is a family of TLR family and has been reported to be the principle mediator of~     macrophage activation in response to mycobacterium. Growing amounts of data suggest that the~     ability of certain individuals to respond properly to TLR ligands may be impaired by single~     nucleotide polymorphisms (SNPs) within TLR genes, resulting in an altered susceptibility to,~     or course of, infectious disease. The genetic polymorphism of TLR2 (arginine to glutamine~     substitution at residue 753 (Arg753Gln)) has been associated with a negative influence on~     TLR2 function, which may, in turn, determine the innate host response to mycobacteria. In~     addition, another polymorphism (Arg677Trp) of the TLR2 was reported to be associated with~     susceptibility to tuberculosis in Tunisian patients. Moreover, in Mycobacterium leprosy~     patients with TLR2 mutation (Arg677Trp), production of IL-2, IL-12, IFN-gamma, and TNF-alpha~     by M. leprae-stimulated peripheral blood mononuclear cell were decreased compared with that~     in groups with wild-type TLR2.~      To date, there have been no studies of the association of SNPs of TLR2 with cytokine profiles~     and clinical outcomes on M. tuberculosis. We hypothesize that polymorphisms in the TLR2 are~     associated with :~        1. increased prevalence of active pulmonary TB infection,~        2. altered levels of pro-inflammatory and anti-inflammatory cytokines in serum,~        3. clinical outcomes and presentations. We thus design a prospective case-control study to~          test this hypothesis. The frequency of TLR2 polymorphisms in both pulmonary TB patients~          and healthy controls will be determined by polymerase chain reaction-restriction~          fragment length polymorphism. Serial serum levels of IL-12, IFN-γ, and IL-10 in~          pulmonary TB patients with or without TLR2 polymorphisms will be measured by enzyme~          linked immunosorbent assay. Relationships between TLR2 polymorphisms and serum cytokines~          dynamics or clinical outcomes will be analyzed.~   "
212976|NCT00772395|"~     Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after~     uncemented total hip arthroplasty?~   "
212977|NCT00772382|"~     The primary objective of this study is to demonstrate the long-term safety and tolerability~     of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with~     hyperphosphatemia.~      The secondary objective of this study is to assess the long-term efficacy of flexible doses~     of MCI-196.~   "
212978|NCT00772369|"~     The purpose of this survey is to collect selected safety data.~      Primary Objective:~      To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.~   "
212979|NCT00772356|"~     This crossover, glucose-clamp study will investigate the impact of different basal insulin~     infusion rates on glucose control employing insulin pumps with different insulin delivery~     regimen. Patients will be randomized in one of 2 groups, to receive on the first study day~     insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day~     they will be switched to treatment with the alternative delivery regimen. The anticipated~     duration of the trial is 2 study days and the target sample size is 14 individuals.~   "
212980|NCT00772343|"~     Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine~     versus placebo in the 9 week period after the third dose of the study vaccine in subjects~     with first episode of CDI receiving antibiotics standard of care.~      Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus~     placebo in subjects with first episode of CDI receiving antibiotics standard of care.~   "
212981|NCT00772330|"~     Assess the safety and performance of the Miami InnFocus Drainage Implant in patients~     suffering from glaucoma that is inadequately controlled on tolerated medical therapy with~     intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.~   "
212982|NCT00772317|"~     For the treatment of locally recurrent prostate cancer following failed external beam~     radiation therapy (EBRT)~   "
212983|NCT00772304|"~     To compare patient perceptions of the sensory attributes, including taste and aftertaste, of~     Olopatadine relative to azelastine when administered as a single dose in patients with~     allergic rhinitis.~   "
212984|NCT00772291|"~     Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered~     as the most frequent complication after inguinal hernia surgery. The primary objective of~     this randomised double-blind placebo-controlled trial is to investigate whether pregabalin~     reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.~   "
212985|NCT00772278|"~     Purpose of this study:~      Primary:~      • Comparison of cardiovascular mortality and morbidity which includes cardiac and~     neurological morbidity (TIA and CVA) in the two invasive treatments of asymptomatic carotid~     artery stenosis~      Secondary:~        -  Comparison of non cardiovascular morbidity caused by the two invasive techniques~             1. morbidity at the site of incision (infection or local hematoma)~             2. damage to cranial nerves (hypoglossus, vagus)~             3. brain hyperperfusion which is defined as severe headache which is not responsive to~               analgesics with or without nausea and vomiting.~             4. events of bradycardia within the first 24 hours, clinically evident and/or silent~        -  microembolic brain events immediately after the procedure and their relationship with~          morbidity and/or mortality due to TIA's or CVA's~        -  the change in the stenotic carotid artery at the time of follow up with duplex of neck~          arteries~        -  the comparison of the affect of the two procedures on patient life style~   "
212987|NCT00772252|"~     Background: In patients undergoing hemodialysis or hemofiltration will suffer from the injury~     of reactive oxidative species. Oxidative stress will affect cell membrane, protein, and DNA.~     It will damage the cell and result in organ dysfunction. We believe that in patients, who~     have acute hepatic failure, undergoing plasma exchange or Molecular Absorbent Recirculating~     System for bridge therapy will suffer from the injury of reactive oxidative species, too. It~     will damage the kidney, lung, cerebral cortex, and other organs. It may result in death~     before the recovery of liver function or undergoing liver transplantation.~      Aims: 1. Investigate the severity of oxidative stress and risk factors of high oxidative~     stress in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent~     Recirculating System. 2. Investigate the microcirculation status and risk factors in acute~     hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating~     System. 3. Study the relationship between oxidative stress and microcirculation status. 4.~     Study the correlation between oxidative stress and prognosis. 5. Study the correlation~     between microcirculation status and prognosis.~   "
212988|NCT00772239|"~     Cardiac surgery is bleeding requiring transfusion surgery .~      The haemorrhagic is related to the need to use high doses of anticoagulants to prevent~     thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors~     consumming despite conducting a thorough anticoagulation.~      All these changes contribute to increase the need for transfusions during heart surgery.~      The main objective of this study is to compare the need for transfusions in patients~     suffering from bleeding complications after cardiac surgery with a therapeutic algorithm~     based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.~      100 pateinst (50 in each arm) should be included in this trial.~   "
212989|NCT00772226|"~     The study is undertaken to investigate whether relaxing music therapy before, during and~     after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of~     stress as measured by Cortisol and C reactive protein.~      Patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1~     and 7 post-OP.~   "
212990|NCT00772213|"~     Controlled clinical intervention study comparing the treatment of multiple trauma patients in~     a newly developed combined diagnostic and operation room, the multifunctional image guided~     therapy suite (MIGTS) versus controls. The MIGTS proved to significantly accelerate the~     procedure and led to more satisfied team members.~   "
212991|NCT00772200|"~     This research trial studies neuropsychological (learning, remembering or thinking) and~     behavioral testing in younger patients with cancer. Collecting information over time from a~     series of tests may help doctors develop effective tests to measure neuropsychological and~     behavioral function of patients with cancer.~   "
212992|NCT00772187|"~     Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We~     would like to compare different analgesic methods.~   "
212993|NCT00772174|"~     The purpose of this study was to determine the efficacy of pioglitazone taken with metformin~     on high-density lipoprotein cholesterol in subjects with Type 2 Diabetes.~   "
212994|NCT00772161|"~     This study is designed to provide pharmacokinetic data for the assessment of bioequivalence~     of Ritalin LA formulation compared to Medikinet ret. concerning plasma levels and efficacy~     measures.~      The primary objective of the study is to determine the pharmacokinetic parameters and~     bioequivalence of Ritalin LA compared to Medikinet retard, both given as oral o.d. doses of~     20 mg over 7 days in children with ADHD. The secondary objectives are to assess the efficacy,~     safety and tolerability of Ritalin LA and Medikinet retard and the association of these~     parameters with plasma levels.~   "
212995|NCT00772148|"~     The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of~     medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf®~     capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a~     transplanted kidney and liver. LCP-Tacro is a tablet containing the same active ingredient~     (tacrolimus) that is in Prograf capsules, but the tablet has been designed to release~     tacrolimus over an extended period so that it only has to be taken once daily. LCP-Tacro is~     an investigational drug.~      This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a~     liver transplant in patients randomly assigned (by chance, like flipping a coin) to take~     either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In~     addition, patients will remain on study drug for 360 days in order to evaluate the relative~     safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.~   "
212996|NCT00772135|"~     The purpose of this study is to determine whether oral sildenafil citrate reduces the~     abnormal right ventricular pressure response during exercise in adolescent and adult patients~     with specific types of congenital heart defects.~   "
212997|NCT00772122|"~     In order to investigate the effectiveness of G-CSF in preventing embryo demise, the~     investigators administered this cytokine to women with recurrent miscarriage in a randomized~     controlled study compared to women treated with placebo. Sixty eight women with unexplained~     primary recurrent miscarriage, all of them with at least four consecutive abortions and~     negative for all clinical investigations were selected for this study. Patients were randomly~     treated with G-CSF, starting on the 6th day after ovulation, or with placebo.~   "
212998|NCT00772109|"~     This study is designed to test lot consistency of three different manufacturing lots and to~     generate safety and immunogenicity data of the investigational vaccine administered via the~     ID route.~      Primary Objective:~        -  To demonstrate lot consistency of the Fluzone ID manufacturing process.~        -  To provide information concerning the immune response of Fluzone ID.~      Secondary Objectives:~      Safety~        -  To describe the safety profile of subjects who receive of Fluzone ID.~   "
212999|NCT00772096|"~     Delirium and long-term cognitive dysfunction are important problems in intensive care~     patients. Patients with sepsis are at a high risk of developing delirium (septic~     encephalopathy), which may be an important risk factor for the development of long-term~     cognitive dysfunction.~      Working hypotheses: 1. Septic encephalopathy and cognitive dysfunction are caused by an~     unspecific reaction of the brain to an intense inflammatory stimulus. 2. It is possible to~     therapeutically influence the inflammatory response and its effects on the brain.~   "
213713|NCT00762541|"~     The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in~     the treatment of moderate to high myopia (nearsightedness), when used as part of the Laser In~     Situ Keratomileusis (LASIK) procedure.~   "
213000|NCT00772083|"~     Blood donors are a precious community resource. Each month at Blood Center of Wisconsin~     (BCW), 200 men and 600 women over age 50 are turned away (deferred) because of anemia. In~     those over 50, anemia may signal serious underlying disease such as colorectal cancer (CRC).~     CRC is the #3 cause of cancer death in Wisconsin with more than 1,000 deaths in 2006. Yet~     with proper testing CRC outcomes can be improved by early diagnosis. This project will focus~     on a population of deferred older blood donors to develop and test educational materials that~     will motivate donors to seek medical attention for their anemia, so that the underlying cause~     is diagnosed and treated. This project has the potential to lead to better CRC outcomes in~     Wisconsin blood donors.~   "
213001|NCT00772070|"~     This study was designed to simulate meningococcal challenge by vaccination with a fractional~     combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in~     children who were vaccinated with one dose of TetraMenD at least 18 months earlier.~      Primary Objective:~      To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants~     who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine~     to those responses in participants who received the same reduced dose of Menomune® but had~     not previously received any meningococcal vaccine.~   "
213002|NCT00772057|"~     Background and Aims: The efficacy of portal pressure reduction by beta blockers for the~     management of small (≤5 mm) esophageal varices in patients of cirrhosis is not clear. The~     present randomized controlled trial aims to address these issues. The investigators also~     assessed the utility of serial HVPG measurements in these patients.~      Patients and Methods: Consecutive patients with cirrhosis with small varices, with no history~     of variceal bleed, were randomized to receive propranolol or placebo. These patients were~     further randomized to undergo no HVPG, only baseline HVPG, or serial HVPG measurement.~     Propranolol was titrated to reduce heart-rate to 55/min.~   "
213003|NCT00772044|"~     Primary Endpoints:~      •Comparison of difference in AHI at one-week in-lab polysomnography between device on and~     device off nights, controlling for sleep position (supine vs. non-supine)~      Secondary Endpoints: By polysomnography, reduction in:~        -  AHI with device on vs. off at 3 months, controlling for sleep position~        -  Oxygen desaturation index with device on vs. off~        -  Arousal index with device on vs. off~        -  Duration of snoring with device on vs. off~        -  Epworth Sleepiness Scale~      Patient acceptance, in terms of:~        -  Refusal rate at screening~        -  Discontinuation rate during follow-up~        -  Daily compliance rate~        -  Device-related adverse events~        -  Serious adverse events~   "
213004|NCT00772031|"~     The purpose of this study is to compare the reduction in the number of severe headache days~     at six months in people with chronic migraine treated with topiramate and propranolol versus~     those treated with topiramate and a placebo.~   "
213005|NCT00772018|"~     RATIONALE: Learning about quality of life and symptom management in patients with bladder~     cancer may help doctors learn about the effects of treatment and plan the best treatment.~      PURPOSE: This clinical trial is studying of quality of life and symptom management in~     patients with bladder cancer.~   "
213006|NCT00772005|"~     The primary objective of the study is to evaluate whether armodafinil treatment is more~     effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the~     negative symptoms of schizophrenia~   "
213007|NCT00771992|"~     The effect of surfactant protein D under native and altered conditions will be investigated~     in immune cells that are derived from bronchoalveolar lavage in patients with allergic asthma~     following segmental allergen challenge. The goal of this study is to elucidate the pro-~     versus anti-inflammatory function of SP-D molecules and to identify motifs of SP-D that have~     treatment potential in allergic asthma.~   "
213008|NCT00771979|"~     The aim of the study is to compare how different formulations of AZD0530 are absorbed by the~     body. As for all clinical trials, safety and tolerability of the drug will be evaluated.~   "
213009|NCT00771966|"~     The optimal amount of fluid a patient need under surgery is not clear. Both to much and to~     little fluid can damage the organ functions.~      A strategy called Goal directed therapy, where the fluid amount a patient need is guided by~     the stroke volume, has shown to minimize post-operative nausea and vomiting.~      The investigators intend to investigate if patients treated after these standards, has a~     better outcome then patients treated after normal regimes, regarding post-operative~     orthostatic-intolerance.~   "
213010|NCT00771953|"~     The primary objective is to determine the anti-tumor activity of the combination of apricoxib~     + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel~     (P/DC) or pemetrexed (P/PE) as measured by progression free survival in patients with Stage~     IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).~   "
213011|NCT00771940|"~     The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and~     lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that~     ghrelin infusion causes insulin resistance and lipolysis.~   "
213012|NCT00771927|"~     SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the~     long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in~     patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on~     current therapy. Using reported adverse events, the incidence of certain cardiovascular and~     psychiatric events will be evaluated.~   "
213013|NCT00771914|"~     The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet~     effects of aspirin.~   "
213014|NCT00771901|"~     Normally, the hormone insulin works to help keep blood sugar normal. However, as a person~     gains weight, insulin does not work as well and blood sugar tends to be a little higher than~     normal. This is called insulin resistance.~      Two investigational drugs (not approved by the Food and Drug Administration) for the~     treatment of high lipid levels or insulin resistance are being examined in this study: one~     drug is called tauroursodeoxycholic acid (TUDCA), the other is called sodium phenylbutyrate~     (PBA). This study is designed to test if TUDCA and/or PBA is effective in people who are~     obese with insulin resistance and high lipids. We hypothesize that pharmacologically-induced~     decreases in ER stress will improve insulin action and hepatic lipid metabolism in obese~     subjects.~   "
213714|NCT00762528|"~     Plaque induced gingivitis~   "
213715|NCT00762515|"~     The objective is to compare two commerical oral products for the treatment of gingivitis.~   "
213015|NCT00771888|"~     Positive data originating from two polycystic liver patients treated with somatostatin~     analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated~     polycystic livers and no other therapeutic options were available.~      Patients who participated in LOCKCYST trial are able to benefit from active treatment.~     Participants will be actively treated for 24 weeks.~   "
213016|NCT00771875|"~     This study is being conducted to determine how safe and effective using an immune cell (b~     cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are~     experiencing certain types of rejection.~   "
213017|NCT00771862|"~     The purpose of this research study is to determine if putting local anesthetic through one or~     two percutaneous catheters placed next to the nerves that go to an amputated limb will~     decrease long-term pain in the amputated limb.~   "
213018|NCT00771849|"~     The study investigated safety profile and the antibody responses to an experimental~     tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have~     received a monovalent meningococcal C conjugate vaccine at least one year previously.~      Primary objective:~      To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C~     in participants receiving Menactra® to the serogroup C antibody response in a control group~     of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28~     days following vaccination.~   "
213019|NCT00771836|"~     Background: Stem cell transplantation (SCT) is associated with pulmonary complications and~     may lead to high morbidity and mortality. We encountered several children post-SCT with a~     clinical picture suggestive of airway hyper-reactivity (AHR) and evidence of reversible~     airway obstruction that was not reported pre-transplant. Our aim was to determine if SCT~     induced AHR as assessed by methacholine challenge test (MCT) and to determine any correlation~     between AHR and pulmonary complications.~      Methods: Prospective study evaluating consecutive patients referred for SCT to the Department~     of Pediatric Hemato-Oncology at Meyer Children's Hospital. Evaluation included pulmonary~     function test and methacholine challenge test before and after the transplantation, and~     assessment of pulmonary complications.~   "
213020|NCT00771823|"~     A placebo controlled study of the impact on insulin sensitivity and lipid profile of~     maraviroc 300 mg twice daily in HIV negative male volunteers.~   "
213021|NCT00771810|"~     This research study will investigate the safety and effectiveness of two different dose~     levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine~     and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian~     cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see~     if it will help reduce some of the side effects of the chemotherapy, primarily low blood~     platelet levels that lead to excess bleeding. This study also intends to test the safety of~     TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6~     cycles of the prescribed chemotherapy.~   "
213022|NCT00771797|"~     To assess the clinical efficacy and to simultaneously explore the underlying molecular~     mechanisms of the beneficial effects of flavanol-rich cocoa on vascular function diabetic~     patients with peripheral artery occlusive diseases (PAOD) of the lower extremities will be~     investigated.~   "
213023|NCT00771784|"~     The length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask~     during percutaneous tracheostomy.~   "
213024|NCT00771771|"~     The main purpose of this study is to evaluate the benefit of early supported discharge (ESD)~     in rehabilitation of stroke patients in two different outpatient modalities.~      In a collaborating study, changes in physical function as well as the patients' own~     perception of physical function, pain and fatigue will be studied. In further collaborating~     studies, health economics and organizational issues will also be evaluated.~   "
213025|NCT00771758|"~     The purpose of this study is to determine the effectiveness and safety of tapentadol~     immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain~     caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom~     treatment with oral opioid analgesics is appropriate.~   "
213026|NCT00771745|"~     To determine how safe and effective giving Thymoglobulin before transplantation to patients~     who are going to be receiving kidney transplants.~   "
213027|NCT00771732|"~     To see if four sessions of light therapy successfully treats nail fungus.~   "
213028|NCT00771719|"~     The purpose of this research study is to measure the levels of ceftobiprole in the blood,~     urine and tissues of the lungs during and after administration of four doses of ceftobiprole.~     Safety of the drug will also be evaluated.~   "
213029|NCT00771706|"~     Cough is both an important physiologic component of lung defense and a cardinal indicator of~     disease. For those with chronic cough, defined as cough lasting for more than 3 weeks, the~     differential diagnosis is broad, including self-limited, persistent, and chronic diseases.~     The success of a given treatment depends upon a proper diagnosis, yet this is often not~     obvious. Gastroesophageal reflux (GER) has been proposed as one possible etiology of a~     chronic cough in a number of studies in the adult literature; nevertheless a clear cause and~     effect remains to be confirmed as there continues to be no gold standard test definitively to~     identify pathologic GER. Each year, billions of dollars are directed towards diagnosing and~     treating GER as it relates to adults and children with a chronic cough but without solid~     proof of effect.~      We propose to test the null hypothesis that there is no causative role of GER with regards to~     the etiology of chronic cough in children. If the null hypothesis proves true, this has~     important medical and economic ramifications, as it would suggest that treatment of acid~     reflux for chronic cough in a child is unwarranted. With this conclusion, health care costs~     would be reduced and children spared inappropriate medication.~   "
213030|NCT00771693|"~     The postprandial phase in diabetic patients is characterized by a rapid increase in blood~     glucose levels, increase in platelet aggregation, LDL oxidation and over production of~     thrombin.~      The aim of the study is to determine whether meal induced platelet activation is related to~     post-prandial hyperglycemia, and can be attenuated by good postprandial glucose control with~     rapidly acting insulin in patients with T2DM.~   "
213031|NCT00771680|"~     This study is conducted in Europe and Asia. The aim of this observational study is to~     evaluate the effectiveness and the incidence of serious adverse reactions while using~     Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used~     insulin previously under normal clinical practice conditions.~   "
213032|NCT00771667|"~     A medical research study in adult patients who have moderate to severe Crohn's disease~     designed to determine whether or not treatment with an experimental drug called ustekinumab~     (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of~     Crohn's disease.~   "
213033|NCT00771654|"~     This is a prospective, randomized, double-blind controlled trial. The goal is to show whether~     the administration of daily oral Phentermine will augment patient weight loss and resolve~     obesity associated comorbidities following gastric band operation.~   "
213034|NCT00771641|"~     RATIONALE: Patient abstract not available~      PURPOSE: Patient abstract not available~   "
213035|NCT00771628|"~     Patients presenting for elective surgery requiring tracheal intubation will be randomized to~     one of two different ETT stylets. The primary outcome is time to intubation.~      The null hypothesis is that there will be no difference.~      The GlideScope video laryngoscope (Verathon) is a widely used intubating device that uses a~     high-resolution camera embedded into a plastic laryngoscope blade. An LED provides~     illumination. The GlideScope often provides a good laryngoscopic view, but passing the~     endotracheal tube (ETT) through the vocal cords is sometimes difficult. Because of the 60~     degree anterior curvature of the GlideScope's blade, ETT's must have stylets inserted so that~     the ETT distal tip can be positioned anteriorly. Various authors have recommended different~     angles of the ETT to optimally place it into the trachea, including matching the GlideScope's~     60 degree angle, or configuring the ETT with a 90 degree bend. Previous studies demonstrated~     that 90 degree sharp bend was both faster and subjectively easier in a heterogeneous group of~     intubators. With the introduction of the Flex-It stylet by Parker Medical, the question~     arises as to the the best configuration of stylet for the ETT. Therefore, this prospective,~     randomized, single-blinded trial is proposed.~   "
213036|NCT00771615|"~     The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK~     1557484A is immunogenic when given to adults aged 18-64 years.~   "
213037|NCT00771602|"~     The goal of this clinical research study is to find out how well Campath (alemtuzumab),~     Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia~     (CLL) that is left after chemotherapy. The safety of these drugs will also be studied.~   "
213038|NCT00771589|"~     The purpose of this study is to develop a robust, low-power, stable, and light weight, active~     knee prosthetic device that can dramatically increase gait symmetry and walking economy of a~     transfemoral amputee during walking.~      State of the art prosthetic knees can be classified into three main classes: a) mechanically~     passive, b) variable-damping, and c) powered. Although the devices within each of these~     classes offer some advantages for above-knee amputees, their overall performance still~     presents some deficiencies. Artificial knees in the first two groups are predominantly~     damping devices, incapable of providing positive power output. Moreover, current powered~     prostheses are heavy and inefficient in their energy consumption, and/or they have a limited~     range of motion. To overcome such inadequacies, we have designed a novel prosthetic knee~     device with a biomimetic approach.~      The design of the active knee prosthesis is inspired by the antagonistic muscle anatomy of~     the human knee joint. This device mimics the synergistic muscle activity at the knee using a~     double series-elastic actuator (SEA) system that resembles the major mono-articular muscle~     groups that help flex and extend the knee joint. The agonist-antagonist SEA knee architecture~     will allow for precise force control of the knee joint, mimicking the spring-like behavior of~     the human knee, as well as providing adequate energy for forward progression of the body. The~     SEA has been previously developed and tested on legged robots. Also, the SEA has been~     successfully applied to the development of an actuated ankle-foot orthoses (AAFO) at MIT AI~     Lab.~      The mechanical architecture of the active knee prosthesis allows for independent engagement~     of flexion and extension tendon-like, series springs for the control of joint position and~     impedance, as well as net joint torque. Furthermore, this architecture permits a joint~     rotation with near zero friction, allowing the controller to take advantage of the passive~     dynamics of the system, thus, augmenting the overall energetic efficiency of the system.~   "
213039|NCT00771576|"~     The investigators hypothesize that PET scans will be able to differentiate between normal,~     reduced or increased BCM in human subjects. Subjects with normal BCM will be recruited from~     among normal weight nondiabetic people with plasma insulin levels within the normal range.~     Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have~     with low or not measurable insulin levels. If results from the nondiabetic subjects and the~     subjects with T1DM are found to differ significantly, subjects with increased BCM will be~     recruited from among patients with hyperinsulinemia including those with obesity and the~     metabolic syndrome. PET scan measurements of the pancreas will be obtained and compared in~     people predicted, on the basis of biochemical testing, to have normal or reduced, or~     increased BCM.~   "
213040|NCT00771563|"~     Rationale: a number of recent phase III randomized trials have shown a survival benefit of a~     treatment with subcutaneous low-molecular weight heparin in patients with advanced solid~     malignancies. The survival advantages observed in the studies persist for months after the~     active treatment with LMWHs. Therefore these survival advantages are thought to be due to~     effects of LMWHs on tumor cell biology.~      First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination~     has been widely studied, and is amongst the most active treatments currently available. The~     occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range,~     making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced~     NSCLC.~   "
213041|NCT00771537|"~     The purpose of this study is to test the effects of different persuasive informational~     messages on rates of rapid HIV testing and willingness to participate in a HIV vaccine~     clinical trial. Adult African-American, non-Latina White, and Latina women will be recruited.~     Women will initially be randomized to 4 groups: 1. no message control; 2. 1-sided message~     that mentions benefits of HIV testing; 3. 2-sided message that acknowledges minor opposition~     to testing, then refutes the opposition; and 4. 2-sided message that acknowledge stronger~     opposition to testing, then refutes the opposition. Women will be offered HIV testing, then~     re-randomized to a similar set of 4 messages related to HIV vaccine trials. There will~     therefore be 16 groups in total (4 X 4).~   "
213042|NCT00771524|"~     This study is being performed to measure the amount of the antibiotic ceftobiprole (study~     drug) found in the bone and blood after receiving one dose prior to your elective hip~     replacement surgery. A piece of your hip bone which will be removed as part of your surgery~     will be analyzed to determine how much ceftobiprole gets into the bone.~   "
213043|NCT00771511|"~     In the setting of fetal demise it is important to help the mother deliver the fetus~     expeditiously and with as little physical trauma as possible. We hypothesize that application~     of capsaicin to the uterine cervix will enhance cervical ripening and desensitize pain fibers~     such that delivery is less painful.~   "
213716|NCT00762502|"~     To evaluate two toric contact lenses on the ocular physiology of existing contact lens~     wearers when used in an extended wear modality of days/six nights.~   "
213044|NCT00771498|"~     This is a pharmacokinetic, descriptive, open-label, prospective, multicentric, national study~     in Aids and tuberculosis co-infected patients, to be laboratory and clinically monitored~     during the treatment with lopinavir-ritonavir and rifampin medications.~      Study population: Thirty patients older than 18 years, both male and female, which present~     active tuberculosis and failure or contraindication for any motive to an efavirenz will be~     selected to participate in the study.~      Objectives:~        -  Evaluate the pharmacokinetics of lopinavir-800mg / ritonavir-200mg combination (every 12~          h) in association with rifampin-containing anti-tuberculosis regimens, in patients~          presenting tuberculosis and HIV-infected with indication to antiretroviral treatment~          according to Brazilian Ministry of Health's guidelines, with contraindication to the use~          of NNTRI.~        -  Describe the adverse events observed during the tuberculosis treatment period with~          rifampin associated with antiretroviral therapy consisting of lopinavir-800mg /~          ritonavir-200mg every 12 hours.~        -  Describe clinical, immunological and virological endpoints throughout the study with~          these drugs.~   "
213045|NCT00771485|"~     The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation~     before colonoscopy.~   "
213046|NCT00771472|"~     Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese~     patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in~     Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be~     newly enrolled in Part II.~   "
213047|NCT00771459|"~     The purpose of this study is to examine whether local infiltration analgesia (LIA) with~     Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major~     spine surgery.~   "
213048|NCT00771446|"~     Evaluate on how well the ELAD system works in treating people with liver failure.~   "
213049|NCT00771433|"~     RATIONALE: G-CSF may prevent or reduce febrile neutropenia in women receiving chemotherapy~     for breast cancer. It is not yet known which G-CSF regimen is more effective in preventing~     neutropenia.~      PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia in~     women receiving chemotherapy for breast cancer.~   "
213050|NCT00771420|"~     Investigate safety and tolerability of the escalating dose of CAM-3001 in patients.~   "
213051|NCT00771407|"~     The purpose of this study is to compare the clinical outcomes of patients undergoing surgery~     for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay,~     as measured by postoperative occurence of parastomal hernia.~   "
213052|NCT00771394|"~     To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive~     bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH)~     with tamsulosin hydrochloride for at least 6 weeks~   "
213053|NCT00771381|"~     In about half the cases of breast cancer, there is hypoxic (no, or little oxygen) tissue~     present. Hypoxic cells can be resistant to treatment and may cause increased tumour growth.~     This study will use 18F-FAZA PET scans before surgery or treatment to assess whether patients~     have hypoxic tumours. The results will be compared to tissue samples removed during surgery~     and to the distribution of 18F-FDG.~   "
213054|NCT00771368|"~     The purpose of this study is to determine if gaseous nitric oxide is effective in the~     treatement of bacteria in MRSA positive ulcers~   "
213055|NCT00771355|"~     This is a pilot study to evaluate the findings of the Reflectance Confocal Microscopy when~     performed in cutaneous pigmentary disorders, such as vitiligo, melasma, post-inflammatory~     hyper-pigmentation and hypo-pigmentation. Confocal Microscopy is a recent diagnostic~     technique that has been used for observation of skin conditions that affect the superficial~     layers of the skin.~   "
213056|NCT00771342|"~     The purpose of this study is to determine the fungicidal efficacy of nitric oxide and it's~     effect on the clinical signs and symptoms associated with Tinea Pedis~   "
213057|NCT00771329|"~     Phase I study designed to determine the safety and tolerability of a single dose of BIIB023~     administered intravenously versus placebo to subjects with RA.~   "
213058|NCT00771316|"~     The purpose of this study is to demonstrate that MK0826 is comparable to Meropenem in the~     treatment of complicated Urinary Tract Infections (UTIs) in adults.~   "
213059|NCT00771303|"~     Venous thromboembolism (VTE) remains a major cause of maternal morbidity and mortality in~     developed countries. Objective diagnosis of pulmonary embolism (PE) and/or deep vein~     thrombosis (DVT) in pregnancy is crucial. Failure to identify PE or/or DVT will place the~     mother's life at risk, and unnecessary treatment will not only expose her to anticoagulants~     but will also label her as having had VTE. Thus, this diagnosis has serious implications for~     the management of her present pregnancy, and for other aspects of her life ranging from~     contraception to thromboprophylaxis in future pregnancies and hormone replacement therapy in~     later life. It is therefore critical that all women with symptoms or signs that suggest~     venous thromboembolism have appropriate investigation and diagnosis based on objective~     diagnostic tests.~      The current diagnostic approach in suspected PE is based on sequential diagnostic tests: 1)~     assessment of clinical probability, 2) fibrin D-dimer measurement, 3) compression~     ultrasonography of lower limb veins and 4) multi-slice computed tomography (MSCT). However,~     physicians are reluctant to perform MSCT in pregnant women because of potential adverse~     effect of radiation exposure to the fetus. For this reason, ventilation/perfusion or~     perfusion-only lung scan has been the cornerstone of PE diagnosis in pregnant women. Indeed,~     perfusion lung scan was assumed to be associated with less radiation than computed tomography~     (CT). However, this technique is now widely abandoned in the usual diagnostic strategy of PE~     for the following reasons: it is not widely available; its interpretation may be difficult~     and the test may be inconclusive in the presence of other chest abnormalities. Moreover,~     recent data convincingly show that the radiation exposure associated with single-slice or~     multi-slice CT exposes the fetus to less radiation than perfusion lung scan.~      However, the use of CT has never been adequately validated in pregnant women with clinically~     suspected PE. The investigators, therefore, plan to set up a prospective management study in~     which pregnant women with suspected PE will undergo a sequential diagnostic strategy based on~     1) assessment of clinical probability 2) D-dimer measurement 3) compression ultrasonography,~     and 4) MSCT.~      Nowadays, the overestimated fear of radiation exposure for the fetus leads to an irrational~     attitude and inadequate investigations in pregnant women with suspected PE, even though both~     European [3, 4] and North-American guidelines [5] suggest that only objective testing may~     accurately rule out the disease. The proposed study should lead to an increased awareness of~     the risks and benefits of appropriate imaging in pregnant women suspected of PE and should~     result in a more rational management of this under-studied patient group.~   "
213078|NCT00771056|"~     Eligible CLL patients who sign an informed consent will be started on hydroxychloroquine~     400mg po daily for up to one year. They will be monitored for disease status as well as~     adverse reactions after two weeks and then every 4 weeks. Ophthalmologic exams is required at~     baseline and every 6 months or sooner if the patient develops any visual disturbances.~   "
213079|NCT00771043|"~     Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to~     evaluate the neuroprotective effects of Natalizumab (TYSABRIÂ®) or Interferon beta-1a~     (AVONEXÂ®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL~     thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple~     Sclerosis (RRMS).~   "
213060|NCT00771290|"~     Intra-operative colonoscopy (inserting a flexible endoscope with a camera at its tip through~     the anus and up into the rectum and colon) is most often indicated to locate or verify the~     location of small cancer, polyp, bleeding site, or simply to inspect the bowel after the two~     ends have been rejoined together. Usually colonoscopy utilizes ambient air to expand and~     inflate the colon and, as a result, leaves the colon bloated or distended until the gas is~     either expelled or absorbed. This endoscopy related bowel distension is problematic in the~     setting of both traditional open (big incision) colorectal surgery and after minimally~     invasive (laparoscopic assisted) procedures.~      In the case of the former, it may prove difficult to close a traditional laparotomy incision~     if the bowel is distended and may hinder respiration with the abdomen closed. In the setting~     of a laparoscopic procedure, the bowel distension limits the working space available to the~     surgeon. Since the laparoscopic domain is limited, a distended colon following~     intra-operative colonoscopy can prevent the minimally invasive completion of a case (meaning~     that a conversion to traditional open methods would be necessary) that otherwise was going~     well with good prospects of laparoscopic completion. Colonic distension also causes abdominal~     pain and lengthens the recovery time from the procedure.~      The investigators believe that the use of CO2 during intra-operative colonoscopy or~     sigmoidoscopy (exam of only the last 2 to 2 ½ feet of the colon) will not cause long lasting~     bloating or distension of the colon as opposed to air. Carbon dioxide is absorbed 250 times~     faster than ambient air and may decrease after procedure colonic distension. This~     prospective, randomized study will compare the two gases in terms of colonic distension.~     Patients undergoing open or minimally invasive colorectal resection will be randomized to~     undergo intra-operative colonoscopy using one of the two gases. Direct measurements of colon~     diameter will be taken at specific time intervals after the colonoscopy.~   "
213061|NCT00771277|"~     Traumatic brain injury (TBI) has been called the signature injury of the Iraq War. This pilot~     study investigated family needs of 6 rural families caring for a Veteran with TBI. Two~     Veterans had moderate TBI and all had comorbid post traumatic stress disorder diagnoses. The~     veterans were 1 to 5 years post-injury. Families were reluctant to include others in helping~     the family because of privacy concerns, desire for independence, and negative employment~     repercussions if the extent of the TBI deficit became known in the community. Most were still~     employed, despite TBI deficits. Despite having previously received information, families~     still had substantial needs for information about the condition and its prognosis and~     sequelae (e.g., why things happen, unsafe/frightening behaviors, work, finances,~     communication changes) and the availability and types of services (e.g., who to contact,~     benefits, help needed)~   "
213062|NCT00771264|"~     The purpose of this study is to demonstrate superiority of percutaneous posterior tibial~     nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with~     overall bladder (OAB) symptoms.~   "
213063|NCT00771251|"~     The purpose of this study is to evaluate the safety and effectiveness of golimumab in~     patients with active rheumatoid arthritis despite DMARD (Disease-modifying antirheumatic~     drugs) therapy. Another objective is to evaluate the pharmacokinetics of golimumab.~   "
213064|NCT00771238|"~     This pilot study will compare the incidence of pressure ulcers and the change in existing~     pressure ulcers for patients who are either placed on the new TC500 bed against those placed~     on the standard ICU bed in the Cardiovascular unit of University of Nebraska Medical Center.~     Additionally, the cost associated with rental beds will be calculated as well as skin care~     compliance. Sixty patients will be enrolled (30 per study arm).~   "
213065|NCT00771225|"~     180 women with genital prolapse will be submitted to genital prolapse surgical correction,~     half of them with human fascia, and the other half with Prolift.~   "
213066|NCT00771212|"~     The purpose of this study is to describe the use of pain treatments in Taiwan, the~     demographics, clinical characteristics of patients requiring pain treatments, current~     treatments, outcomes of treatments and the reasons for changing pain medication during~     treatment.~   "
213067|NCT00771199|"~     The purpose of this study is to evaluate safety/tolerability and clinical utility of low-dose~     transdermal therapeutic system (TTS [medicated adhesive pad that is placed on the skin to~     deliver a timed-release dose of medication through the skin into the bloodstream]) - fentanyl~     in Taiwan participants with cancer pain. Secondly, to demonstrate the dropout rate that will~     be decreased by initiating therapy with12 microgram per hour (mcg/hr) instead of with 25~     mcg/h.~   "
213068|NCT00771186|"~     The goal of this study is to further study the role of LEMG in accurately predicting the~     recovery of vocal function as well to study the timing of a change of LEMG activity prior to~     such return of function. We aim to do this by collaborating with several active pediatric~     otolaryngological practices throughout the country who in turn have agreed to evaluate~     infants and children with vocal fold immobility who fit a standardized inclusion and~     exclusion criteria by means of a standardized LEMG protocol over a one year period of time.~     Our particular goal is to collect and then review information over a one year period of time~     on all children evaluated for vocal fold immobility by means of LEMG.~   "
213069|NCT00771173|"~     The primary aim of this randomized clinical trial is to compare the utility of~     phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the~     post-operative period in the gynecologic patient using mean VAS measurments.~   "
213070|NCT00771160|"~     A clinical study evaluates the efficacy and safety of MK0476 in adult patients with Perennial~     Allergic rhinitis.~   "
213071|NCT00771147|"~     Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and~     calculation of related medical costs.~   "
213072|NCT00771134|"~     This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression~     in patients with bipolar disorder.~   "
213073|NCT00771121|"~     This study is a randomized, double-blind, placebo-controlled bilateral study on the effect of~     moisturizing creams on skin barrier function. The hypothesis is that a new active emulsion~     has a better influence on skin barrier function comapred to its placebo.~   "
213074|NCT00771108|"~     The purpose of this research is to provide a better understanding of how exercise (walking)~     affects non-alcoholic fatty liver disease (NAFLD) in overweight people. NAFLD, which is~     common in obese people, occurs when the liver has too much fat.~   "
213075|NCT00771095|"~     Participants in both the existing and enhanced podcast groups will lose weight. The enhanced~     podcasting group will have a greater increase in weight loss, elaboration, self-efficacy, and~     perceived control than the existing podcast group.~   "
213076|NCT00771082|"~     The purpose of this study is to examine the relationship between body composition and knee~     osteoarthritis, and effects of inflammatory, metabolic, and hormonal factors.~   "
213077|NCT00771069|"~     This study will address the treatment rate and control rate of hypertension, treatment~     pattern and factors to affect blood pressure control by examining (retrospective) medical~     records of Type II DM patients with DM related complication and hypertension, among~     outpatients coming to the Endocrinology Department in 20 general hospital settings~     nationwide.~   "
213080|NCT00771030|"~     This Phase 1b/2a study will evaluate safety, tolerability PK and PD of AMG 827 when~     administered in multiple SC and IV doses in patients with active rheumatoid arthritis in~     combination with a stable dose of DMARDs. Part A is dose escalation (to assess safety &~     tolerability), and Part B is dose expansion (to assess clinical efficacy) at the highest~     tolerated dose level of AMG 827 from Part A.~   "
213081|NCT00771017|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation~     therapy, such as bicalutamide, leuprolide, and goserelin, may lessen the amount of androgens~     made by the body. Vaccine therapy may help the body build an effective immune response to~     kill tumor cells. It is not yet known whether androgen ablation therapy is more effective~     with or without vaccine therapy in treating patients with prostate cancer.~      PURPOSE: This randomized phase II trial is studying androgen ablation therapy to see how well~     it works when given together with or without vaccine therapy in treating patients with~     prostate cancer.~   "
213082|NCT00771004|"~     The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on~     heart functioning before, during and after stent implantation.~   "
213083|NCT00770991|"~     This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized~     black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will~     undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for~     the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the~     initiation of study treatment. The size and number of rectal polyps will be documented on a~     code sheet and by photograph. The efficacy outcome will include the percentage reduction in~     the number of rectal polyps between baseline and 36 weeks.~   "
213084|NCT00770978|"~     The purpose of this research study is to measure the levels of ceftobiprole in the blood and~     urine during and after administration of four doses of ceftobiprole. Safety of the drug will~     also be evaluated.~   "
213085|NCT00770965|"~     This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses~     of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque~     psoriasis will be randomized to receive either AIN457 at one of the three doses studied or~     placebo.~   "
213086|NCT00770952|"~     The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and~     glimepiride combination therapy compared to glimepiride monotherapy in subjects with Type 2~     Diabetes.~   "
213087|NCT00770939|"~     Diabetic foot ulcers are a challenge to health care professionals because there are only few~     effective topical therapeutic interventions.~      Growth factor treatment has shown to be beneficial for healing of diabetic foot ulcers in~     conjunction with extensive surgical debridement. Autologues platelet releasate which contains~     platelet derived growth factor appears to be more effective than standard therapy in case~     studies.~      This protocol will evaluate the healing effect of Vivostat PRF treatment of non-eschemic foot~     ulcers to identify responders and to enable sample size calculation for a subsequent pivotal~     trial.~   "
213088|NCT00770926|"~     This study aims to design and test the effectiveness of a lifestyle diabetes risk reduction~     program, Live Well, Be Well, in reducing risk of diabetes in persons at risk with a focus on~     reaching lower-income, minority individuals.~   "
213089|NCT00770913|"~     The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients~     with Proton Pump Inhibitor-resistant reflux esophagitis.~   "
213090|NCT00770900|"~     Verify if the quantitative parameters of the eosinophils activation and phagocyte system~     function show a predictive value for clinical response and prognostic in patients with~     persistent asthma treated with montelukast~   "
213091|NCT00770887|"~     The purpose of this study is to assess continuation rates and patient satisfaction with self~     administration subcutaneous depot medroxyprogesterone acetate.~   "
213092|NCT00770874|"~     This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3~     study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in~     patients with stage IVB, recurrent or persistent carcinoma of the cervix.~   "
213093|NCT00770861|"~     This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic~     patients with stage 1 or stage 2 hypertension~   "
213094|NCT00770848|"~     The primary objectives of this study are the following:~      Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with~     mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of~     the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio~     (HR) for overall survival (OS) of previously treated subjects with castrate-resistant~     prostate cancer (CRPC)~   "
213095|NCT00770835|"~     The purpose of this study is to determine the efficacy of pioglitazone compared to~     glibenclamide, once daily (QD), taken together with metformin and lifestyle modification in~     type 2 diabetic subjects with cardiovascular disease.~   "
213096|NCT00770822|"~     This study will compare high intensity focused ultrasound to standard brachytherapy in the~     treatment of primary, organ confined prostate cancer.~   "
213097|NCT00770809|"~     This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib~     to see how well they work in treating patients with stage II or stage III breast cancer that~     can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known~     which regimen is more effective in treating patients with breast cancer.~   "
213098|NCT00770796|"~     In this randomized study the investigators wish to explore the role of pre-procedural statin~     therapy for the prevention of contrast induced nephropathy in patients with~     moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.~   "
213115|NCT00770575|"~     The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and~     atorvastatin combination therapy compared to atorvastatin monotherapy in patients at risk for~     cardiovascular disease.~   "
213099|NCT00770783|"~     The investigators intend to test in a single center, clinical pilot efficacy study the~     primary hypothesis that Magnetic Seizure Therapy (MST) as add-on therapy to a controlled~     pharmacotherapy is efficacious in the treatment of refractory major depression assessed with~     the Hamilton Depression Rating Scale (HAMD).~   "
213100|NCT00770770|"~     This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with~     macular edema secondary to RVO.~   "
213101|NCT00770757|"~     This study will test the safety and effectiveness CC-4047 (pomalidomide) in patients with~     advanced, steroid refractory graft-versus-host disease.~   "
213102|NCT00770744|"~     The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in~     patients suffering from schizophrenia compared to a standard antipsychotic drug.~   "
213103|NCT00770731|"~     The goal of this clinical research study is to find the highest tolerable dose of Torisel~     (temsirolimus), Hycamtin (topotecan hydrochloride), and Velcade (bortezomib) that can be~     given, in combination, to patients with advanced cancer that has spread or is unable to be~     surgically removed. The safety of this drug combination will also be studied.~   "
213104|NCT00770718|"~     The purpose of this dose-ranging pilot study is to compare Recombinant Activated Factor VII,~     Prothrombin Complex Concentrate and Fresh Frozen Plasma (each starting at low doses with~     escalation if necessary) for the reversal of warfarin in the setting of acute intracranial~     hemorrhage.~   "
213105|NCT00770705|"~     Phenoxybenzamine, an irreversible alpha-adrenergic blocker, may prove beneficial to infants~     and children with congenital heart disease undergoing open cardiac repair, due to a theoretic~     benefits of a uniform and smooth reduction in systemic vascular resistance in the~     perioperative period. Vasodilation allows for low pressure, high flow systemic perfusion~     while on cardiopulmonary bypass. Support for the use of phenoxybenzamine in humans has been~     documented in several studies involving the perioperative management of both adults and~     children requiring cardiopulmonary bypass, and in management of patients with~     pheochromocytoma. 1-7 Phenoxybenzamine has been associated with more uniform body cooling and~     rewarming, and improved tissue perfusion during bypass.8 It is also known to increase cardiac~     output, stroke volume, and renal blood flow when given intravenously. 9 Specifically in~     pediatric open heart surgery, the combined use of phenoxybenzamine and dopamine provided a~     stable hemodynamic condition without a high total peripheral vascular resistance and~     stimulated postoperative diuresis. 9 Afterload reduction with parenteral phenoxybenzamine in~     neonates undergoing the Norwood procedure for hypoplastic left heart syndrome is associated~     with improved systemic oxygen delivery and stabilization of systemic vascular resistance.10~     Furthermore, a strategy of reducing afterload with phenoxybenzamine and stabilizing the~     pulmonary to systemic flow ratio in this select population of patients has also been shown to~     improve operative survival. 11 We hypothesize that phenoxybenzamine will reduce afterload on~     the systemic ventricle in our selected patient population, thereby improving ventricular~     performance and decreasing the risks of pulmonary to systemic flow imbalance associated with~     current short-acting vasodilator therapy. We will plan to evaluate both physiologic variables~     as well as surgical outcomes in the selected study population.~   "
213106|NCT00770692|"~     The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in~     non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with~     insomnia.~   "
213107|NCT00770679|"~     Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and~     help prevent heart disease. The investigators are testing whether statins improve endothelial~     function more in the arteries that have worse endothelium to begin with. One of the functions~     of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow)~     in different situations. This affects how blood flows through those vessels. Magnetic~     resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs~     noninvasively.~   "
213108|NCT00770666|"~     Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6~     months in smokers with medical illness~   "
213109|NCT00770653|"~     The purpose of this study is to compare pioglitazone and metformin combination therapy, twice~     daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects~     with dyslipidemia.~   "
213110|NCT00770640|"~     The purpose of this study is to determine the metabolic and cardiovascular effects of~     pioglitazone, once daily (QD), and insulin combination therapy in subjects with Type 2~     Diabetes and Renal Failure.~   "
213111|NCT00770627|"~     Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD~     children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the~     effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities,~     anxiety and depression.~      The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could~     avoid the intake the methylphenidate and its associated adverse side effects.~   "
213112|NCT00770614|"~     The purpose of this study is to determine whether hydration with sodium bicarbonate is more~     effective than hydration with sodium chloride to prevent contrast induced nephropathy in~     patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial~     Infarction.~   "
213113|NCT00770601|"~     This study will examine whether a medicine called canakinumab is safe and effective for~     treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as~     chronic infantile neurologic, cutaneous, articular (CINCA) syndrome. This disease can cause~     rash, joint deformities, brain inflammation, problems with the eyes and learning~     difficulties. Canakinumab is an experimental drug that inhibits the action of a protein~     produced by the body called interleukin 1, which is responsible for the symptoms in NOMID and~     also contributes to many other kinds of inflammatory diseases.~      Patients 2 years of age and older with NOMID may be eligible for this study. Participants~     undergo the following procedures:~      Screening Phase~        -  Medical history and review of medical records~        -  Blood tests~        -  Daily diary of symptoms and medicines take~      Washout/Lead-in Phase~        -  Discontinuation of anakinra or other medications~      Treatment Phase~        -  Injection of canakinumab under the skin every 8 weeks for 6 months~        -  Monitoring and evaluations during treatment, including:~        -  Quality-of-life questionnaires and daily diary~        -  Vital signs measurements (heartbeat, blood pressure, temperature)~        -  Blood tests~        -  Electrocardiogram~        -  Tuberculosis skin test~        -  Neurological, eye and skin examinations at beginning and end of study~        -  Cognitive evaluation at beginning and end of study~        -  Lumbar puncture (spinal tap) at the beginning of the study, 2 weeks after the second~          dosing of canakinumab and at the end of the study~        -  X-rays and bone density scan at beginning and end of study~        -  Magnetic resonance imaging (MRI) of the head at beginning and end of study~      Follow-up Phase~        -  Monthly clinic visits after the last dose of canakinumab for a minimum of 60 days~      End-of-Study Evaluation~        -  Series of tests 8 weeks after last dose of canakinumab to evaluate treatment response~          and side effects~   "
213114|NCT00770588|"~     This is a double blind, multicentre, randomized, placebo-controlled study. The eligible~     patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will~     recruit 296 male or female, histologically or cytologically diagnosed locally advanced or~     metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2.~     Patients must have completed 4 cycles of platinum based first line doublet chemotherapy~     without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be~     given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the~     following: gemcitabine, paclitaxel, docetaxel, vinorelbine.~   "
213117|NCT00770536|"~     This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386~     in combination with either pegylated liposomal doxorubicin or topotecan in subjects with~     recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in~     combination with either pegylated liposomal doxorubicin every 4 weeks (cohort A) or topotecan~     weekly on days 1, 8, and 15 of a 28 day dosing schedule (cohort B). Subject enrollment and~     assignment to either cohort will be based on eligibility and the investigator's discretion.~      It is hypothesized that AMG 386, in combination with each of the chemotherapy regimens:~     either pegylated liposomal doxorubicin or topotecan will be safe and well tolerated in~     subjects with recurrent ovarian cancer.~   "
213118|NCT00770523|"~     Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning~     for Younger Patients with Hematologic Malignancies.~   "
213119|NCT00770510|"~     The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in~     Japanese participants with primary insomnia.~   "
213120|NCT00770497|"~     The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on~     low grade inflammation and vascular function in hypertensive patients.~   "
213121|NCT00770484|"~     The main limitation patients with orthostatic intolerance (OI, or postural tachycardia~     syndrome, POTS) have to exercise is related to their increase in heart rate when standing.~     Main pharmacological treatment today is aimed at reducing heart rate with the use of~     betablockers (propanolol), this theoretically could also improve their exercise capacity; if~     their heart rate do not increase as much with the medication, they could exercise more. In~     addition, it has been suggested that in healthy volunteers subjected to head down tilt for 2~     weeks (situation that produces a simulated transient POTS-like state) a single bout of~     intense exercise can improve orthostatic tolerance the day after exercising. The mechanisms~     involved in such response are not that clear but could be an increase in plasma volume~     already diminished in POTS patients. It seems likely that the same could be true for POTS~     patients.~      The purpose of the present study are to pharmacologically improve the amount of exercise POTS~     patients can perform by reducing their baseline heart rate (specific aim 1) and to evaluate~     next day heart responses to an acute bout of intense exercise.~      Therefore, the specific aims of this study are:~        1. To test the hypothesis that lowering heart rate response with propanolol will result in~          an increase in exercise capacity.~        2. To test the hypothesis that a single bout of exercise will result in an improvement in~          orthostatic tolerance the day after exercising.~   "
213122|NCT00770471|"~     RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving ABT-888 together with~     radiation therapy and temozolomide may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-888 when~     given together with radiation therapy and temozolomide and to see how well it works in~     treating patients with newly diagnosed glioblastoma multiforme.~   "
213123|NCT00770458|"~     Validate that circulating cell free fetal nucleic acid can be used to identify a direct~     marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than~     surrogate markers.~   "
213124|NCT00770445|"~     The purpose of this study is to determine the Anti-Inflammation Effects of Pioglitazone,~     twice daily (BID), and Pioglitazone/Metformin Combination Therapy BID in Type 2 Diabetes~     Subjects Treated with Insulin.~   "
213125|NCT00770432|"~     Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare~     the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took~     one of study treatments up to 7 days.~   "
213126|NCT00770419|"~     RATIONALE: Gathering information over time about patients' sense of being a burden on their~     caregiver, and caregivers' sense of burden on themselves, may help doctors learn more about~     the desire to die in patients with late-stage cancer.~      PURPOSE: This clinical trial is studying perceptions of burden in patients with late-stage~     cancer and their caregivers.~   "
213127|NCT00770406|"~     A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.~   "
213128|NCT00770393|"~     Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord~     involvement squamous cell carcinoma of the pyriform sinus.~      The study compare conventional radiotherapy with concurrent cisplatin to induction~     chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary~     end point was the preservation of the larynx. The secondary end points included toxicity,~     causes of death and survival rates.~   "
213129|NCT00770380|"~     A majority of smokers who quit return to smoking within three months of their quit date. This~     study is a randomized trial to investigate the effectiveness of hypnosis versus behavioural~     counseling to promote maintenance of abstinence or relapse prevention in quitting smokers.~     The hypothesis is that hypnosis will be at least as effective as behavioral counseling in~     preventing relapse to smoking in smokers who are able to quit for at least three days.~   "
213130|NCT00770367|"~     SPECIFIC AIMS~        1. To determine whether pioglitazone will reduce levels of asymmetric~          dimethylarginine(ADMA) in patients with diabetes.~        2. To determine whether nitric oxide(NOx) products are increased with pioglitazone~          treatment.~        3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).~   "
213131|NCT00770354|"~     The aim of this study is to compare the overall tumour response rate per RECIST in~     postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in~     combination with letrozole compared to letrozole alone~   "
213132|NCT00770341|"~     The study investigates the efficacy and safety of MK-3009 in participants with skin~     infections, septicemia and right-sided infective endocarditis (RIE) caused by~     methicillin-resistant Staphylococcus aureus (MRSA).~   "
213133|NCT00770328|"~     PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to~     play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with~     antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal~     models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human~     subjects.~   "
234611|NCT00485017|"~     The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in~     obese subjects over a 24-week treatment period.~   "
213134|NCT00770315|"~     This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH~     39641/MK-3641/Amb a 1-U) compared with placebo in participants with ragweed-induced~     rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants~     on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis~     symptoms and require less allergy rescue medications during ragweed pollen season.~   "
213135|NCT00770302|"~     Saxagliptin is a new investigational medication being developed for treatment of type 2~     diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and~     its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses~     of 5 mg saxagliptin in healthy Chinese subjects.~   "
213136|NCT00770289|"~     Tools known as 'depression scales 'are widely used as assessments to evaluate a patient's~     response to treatment. The purpose of this study is the evaluation of the remission rates for~     patients with MDD. The evaluation will involve the use of HAM-D 17, and HAM-D 7~     questionnaires and the comparison of those questionnaires.~   "
213137|NCT00770276|"~     MOPS: Mannheim Obesity Pilot Study~      Introduction:~      Obesity is a central feature of the metabolic syndrome. With increasing prevalence of~     overweight and obesity, the incidence of WHO III° obesity will further augment. In this~     subset of obese patients, metabolic complications and cardiovascular risk are major clinical~     issues. Epidemiological data show that with increased BMI mortality rises (1). The SOS-Study~     demonstrated, for the first time, that bariatric surgery and consecutive weight reduction are~     associated with a decrease in cardiovascular and overall mortality. Significant mortality in~     this study was caused by cardiovascular events and cancer.~      Metabolic Syndrome - MS - Despite varying definitions of the metabolic syndrome, obesity is~     one of its central features. Depending on the definition used, it can represent an obligate~     criterion (IDF) or a facultative parameter (WHO and ATP III). Even though not obligate,~     extreme obesity is a central risk factor for most other parameters of the metabolic syndrome.~      Endothelial dysfunction -ED- represents the initial step of atherosclerosis (3). An~     appropriate measurement is the evaluation by retinal analysis. Epidemiological data~     demonstrate increased cardiovascular risk with retinal vessel pathology (4).~   "
213138|NCT00770263|"~     Define the maximum tolerated dose and dose limiting side-effects of temsirolimus in~     combination wtih erlotinib in patients with resistant solid tumors~   "
213139|NCT00770250|"~     To evaluate the concordance of the most frequently used words by the patients and the~     physicians to express asthma symptoms, according to the patient's level of asthma control.~   "
213140|NCT00770237|"~     In this study, we will compare cue-reactivity in smokers with and without schizophrenia and~     the influence of smoking cues on responding for cigarette puffs under a PR schedule of~     reinforcement. Given the high prevalence of smoking among individuals with schizophrenia,~     understanding some of the environmental factors that serve to maintain nicotine dependence is~     a critical step in improving smoking cessation treatment outcomes. Establishing and~     validating a laboratory model of cue-elicited responsivity and cigarette self- administration~     will allow the investigation of the efficacy of anti-craving medications in people with~     schizophrenia.~      Specific Aims 1) To compare the effects of smoking versus neutral cues on craving, mood, and~     autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia. 2) To~     compare the effects of smoking versus neutral cues on the reinforcing efficacy of tobacco~     cigarettes in smokers with schizophrenia and smokers without schizophrenia.~      Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood~     (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and~     temperature) responsivity. During self-administration trials, primary measures include~     breakpoint (final ratio completed), total number of responses, and number of cigarette puffs~     earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO,~     FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).~      The ratio of 3-HC/cotinine is a phenotypic biomarker of the rate of nicotine metabolism,~     which has been shown to be associated with level of nicotine dependence, various smoking~     behaviors, and treatment outcome (Ho & Tyndale, 2007). We will correlate the primary measures~     with the 3-HC/cotinine ratio to explore possible relationships for future study.~   "
213141|NCT00770224|"~     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find~     cancer cells and carry cancer-killing substances to them without harming normal cells.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as~     cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving a radiolabeled monoclonal antibody together with rituximab and combination~     chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects of giving iodine I 131 tositumomab~     together with rituximab and combination chemotherapy and to see how well it works in treating~     patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin~     lymphoma.~   "
213142|NCT00770211|"~     The study objective is to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over~     placebo by evaluation of treatment success analyzing the investigator's rating on the Facial~     Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients~     with moderate to severe glabellar frown lines will be randomized in a 2:1 ratio to receive~     one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day~     120.~   "
213143|NCT00770198|"~     Chronic liver disease are characterized by increased levels of plasma IL-6, but the~     bioactivity of this cytokine in this disease is not well known. IL-6 receptor complex is~     regulated by multiple receptors subunits: the soluble form of IL-6 Receptor enhance IL-6~     signal by a process called trans-signaling on cells expressing few membrane IL-6 receptors.~     Soluble gp130 is the natural inhibitor of IL-6 trans-signaling. The aim of this study is to~     characterize circulating and liver levels of theses compounds of IL-6 receptor complex, to~     unravel the bioactivity of IL-6 in this disease.~   "
213144|NCT00770185|"~     RATIONALE: Ridaforolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying the side effects of ridaforolimus and to see how~     well it works in treating patients with recurrent metastatic and/or locally advanced~     endometrial cancer.~   "
213145|NCT00770172|"~     RATIONALE: Colony-stimulating factors, such as G-CSF, may increase the number of white blood~     cells found in bone marrow or peripheral blood and may prevent persistent neutropenia in~     patients receiving chemotherapy. It is not yet known which regimen of G-CSF may be more~     effective in preventing neutropenia.~      PURPOSE: This randomized phase III trial is comparing two different regimens of G-CSF to see~     how well it works in preventing persistent neutropenia in patients with solid tumors who are~     receiving chemotherapy.~   "
213146|NCT00770159|"~     This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822~     in healthy postmenopausal women.~   "
213147|NCT00770146|"~     The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen~     for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of~     statin and who have a diagnosis that puts them at least at high risk of coronary heart~     disease (CHD).~   "
213148|NCT00770133|"~     The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline~     ophthalmic solution compared to vehicle and its individual components in alleviating the~     signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.~   "
213149|NCT00770120|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with~     pleural malignant mesothelioma that cannot be removed by surgery.~   "
213150|NCT00770107|"~     Working Hypothesis: a treatment with thiamine improves functional status and heart function~     of patients with congestive heart failure when on a diuretic treatment.~   "
213151|NCT00770094|"~     Comparison of LASIK outcomes using 3 different lasers and a total of 5 different treatment~     platforms.~   "
213152|NCT00770081|"~     This clinical trial is designed to provide additional information on the safety and~     tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in~     patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular~     filtration rate (GFR) < 30 mL/min) for a period of 52 weeks.~   "
213153|NCT00770068|"~     This study will examine whether spring and fall seasonal depression in individuals with high~     sensitivity to pollen is linked to seasonal increases in tree and ragweed pollen.~   "
213154|NCT00770055|"~     RATIONALE: Gathering information about patients with breast cancer over time may help doctors~     learn more about a patient's use of the internet to find information about treatment, symptom~     management, and emotional support.~      PURPOSE: This clinical trial is studying internet use among women with recurrent metastatic~     breast cancer.~   "
213155|NCT00770042|"~     This study is being conducted to examine the effect of three CYP3A4 inhibitors (ketoconazole,~     erythromycin and ritonavir) on the single dose pharmacokinetics of avanafil. Ketoconazole and~     ritonavir are potent inhibitors of CYP3A4 and erythromycin is a moderate CYP3A4 inhibitor.~     Any interaction that is observed would be predictive of other inhibitors of CYP3A4.~   "
213156|NCT00770029|"~     The study objective was to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over~     placebo by evaluation of treatment success analyzing the investigator's rating on the Facial~     Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients~     with moderate to severe glabellar frown lines to be randomized in a 2:1 ratio to receive one~     injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day 120.~   "
213157|NCT00770016|"~     The aim of this study is to further characterize the treatment related changes in insulin~     sensitivity, substrate metabolism and intra hepatic- and intramyocellular lipid content in~     patients with hypothyroidism~   "
213158|NCT00770003|"~     The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848~     administered intranasally to seasonal allergic rhinitis patients.~   "
213159|NCT00769990|"~     RATIONALE: Genistein may increase the effectiveness of radiation therapy in treating pain~     caused by bone metastases.~      PURPOSE: This phase I/II trial is studying the side effects of genistein and to see how well~     it works in treating patients undergoing external-beam radiation therapy for pain caused by~     bone metastases.~   "
213160|NCT00769964|"~     This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the~     treatment of dysmenorrhea. This study is designed to investigate determine the safety,~     tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy~     non-pregnant female volunteers of child bearing age.~   "
213161|NCT00769951|"~     RATIONALE: Gathering information from older patients with newly diagnosed cancer may help~     doctors learn more about the risks of functional decline.~      PURPOSE: This studying is looking at the physical and mental health of older patients with~     newly diagnosed cancer.~   "
213162|NCT00769938|"~     The study will assess the hypothesis that the combination warfarin & clopidogrel 75 mg/day is~     superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect~     to bleeding complications while equally safe with respect to the prevention of thrombotic~     complications in patients with both indications for warfarin use and dual antiplatelet~     (clopidogrel 75mg/day + aspirin 80mg/day) treatment.~   "
213163|NCT00769925|"~     This study will compare the effectiveness of delivering cognitive behavioral therapy for~     children with anxiety disorders through in-person contact versus through workbooks and~     telephone communication.~   "
213164|NCT00769912|"~     To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under~     paracervical block.~   "
213165|NCT00769899|"~     This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess~     the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose~     administration to healthy male Japanese volunteers.~   "
213166|NCT00769886|"~     The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline~     ophthalmic solution compared to vehicle and its individual components in alleviating the~     signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.~   "
213179|NCT00769691|"~     Blood flow to the brain is normally regulated to ensure a constant supply of blood with~     oxygen and nutrients. During heart surgery using cardiopulmonary bypass, blood pressure is~     kept at a level that may or may not be below an individual's lower level of brain blood flow~     autoregulation. If lower, the brain may be exposed to an inadequate blood flow that could~     result in brain damage. The purpose of this study is to examine whether monitoring with a~     non-invasive FDA approved device that measures oxygen saturation of the superficial layers of~     the brain (near infrared spectroscopy) can, when combined with blood pressure measurements,~     provide information on the blood pressure level where brain blood flow is not autoregulated.~     The goal of this research is to develop a method to individualize blood pressure during~     surgery to a level that is within a patient's brain blood flow autoregulation range as a~     means for improving outcomes for patient undergoing heart surgery.~   "
213180|NCT00769678|"~     This study examines whether a permanent stimulation of the diaphragm improves left~     ventricular function in patients with severe heart failure following heart surgery.~   "
213167|NCT00769873|"~     Splenic/portal vein thrombosis is an alarming complication of splenectomy. Retrospective~     studies in the literature have shown the incidence of symptomatic splenic/portal vein~     thrombosis to be between 0.7% (Rattner et al., 1993) to 8% (Winslow et al., 2002). This is a~     single-center, prospective, randomized study in subjects undergoing laparoscopic splenectomy.~     All participants will receive one dose of pre-operative low molecular weight heparin~     (Lovenox®) subcutaneously, 2 hours prior to surgery. Participants will be randomized~     pre-operatively to treatment or control group however the treatment allocation will not be~     revealed until the surgery is complete. Postoperatively, those assigned to the treatment~     group will receive 40 mg of Lovenox® subcutaneously once a day for 21 days; those in the~     control group will not. Patients with severe renal impairment will receive an adjusted dose~     of Lovenox® (30 mg subcutaneous dose daily). All patients will have a baseline abdominal~     Doppler ultrasound preoperatively and a second one done at 14 to 28 days post surgery to~     monitor for the presence of portal vein and/or splenic vein thrombosis. They will also have~     their lipase and liver function tests checked to correlate with the imaging findings.~   "
213168|NCT00769860|"~     Inclusion body myositis (IBM) is the most common progressive and debilitating muscle disease~     beginning in persons over 50 years of age. This study will assess the safety and tolerability~     of Arimoclomol in IBM as compared to placebo over 4 months of treatment.~   "
213169|NCT00769847|"~     This is a prospective study to evaluate outcomes in patients undergoing endoscopic~     craniectomy for isolated, single-suture craniosynostosis.~   "
213170|NCT00769834|"~     Papilledema is defined as swelling of the optic nerves often due to increased intracranial~     pressure. When present, it often indicates life-threatening lesions of the brain such as~     tumors, abscesses, meningitis, encephalitis, venous sinus obstruction or intracranial~     hemorrhage. A similar clinical picture can also be caused by other conditions such as~     malignant hypertension, diabetic papillopathy and uremia. When the intracranial pressure is~     elevated in the absence of any known cause then it is called Idiopathic Intracranial~     Hypertension (IIH). Untreated papilledema can cause progressive optic nerve damage and~     blindness.~      Patients with chronic kidney disease have a number of co-morbidities and thus are at an~     increased risk for developing papilledema. Although clinicians have observed that patients~     with kidney diseases have increased incidence of papilledema (unpublished data by Corbett et~     al), there have been no studies on this subject to date. We believe that a higher incidence~     of papilledema is found in patients with kidney diseases and this study could provide~     evidence to suggest routine ophthalmic screening in this patient group.~      Hypothesis: The prevalence of optic disc swelling is increased in patients with chronic~     kidney disease.~      Purpose: To establish the prevalence of disc edema in patients with chronic kidney disease.~   "
213171|NCT00769821|"~     RATIONALE: Gathering information from breast cancer survivors about lymphedema; its symptoms~     and their impact on shoulder, arm, and hand functioning; and quality of life may help doctors~     learn more about the disease.~      PURPOSE: This clinical trial is studying the impact of lymphedema on breast cancer survivors.~   "
213172|NCT00769795|"~     The purpose of this study is to determine whether combination treatment of prostate cancer~     with IMC-A12 (an antibody which blocks insulin-like growth factor receptor activity) with~     hormonal therapy (testosterone lowering) before prostatectomy, will be more effective than~     prior results with hormonal therapy alone.~   "
213173|NCT00769782|"~     RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal~     stromal tumor.~      PURPOSE: This phase II trial is studying how well surgery works in treating patients with~     liver metastasis from a gastrointestinal stromal tumor.~   "
213174|NCT00769769|"~     This study will compare the effectiveness of face-to-face cognitive behavioral therapy versus~     telephone-based cognitive behavioral therapy for treating African Americans who care for~     family members with dementia.~   "
213175|NCT00769756|"~     Context: Endeavours to reduce overweight by calorie-restriction diets are often neither~     sufficient nor sustained. The growing obesity epidemic demands additional measures to enhance~     and sustain weight loss.~      Objective: To evaluate three alternative weight-loss measures on top of a calorie-restriction~     diet.~      Design, Setting, and Participants: Six-month randomized and controlled trial using a~     three-factorial design. The participants were 110 families with 142 obese parents and their~     119 obese children.~   "
213176|NCT00769730|"~     Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative~     management of patients with hepatocellular carcinoma (HCC). Few previous studies had~     demonstrated that the serum level of anticancer drug from patients treated by TACE was~     similar to those treated by systemic chemotherapy. Since systemic chemotherapy may have the~     possibility to influence patient's general defense ability, hepatitis B virus may reactivate~     after chemotherapy.This study is to investigate the possibility of TACE in the reactivation~     of hepatitis B virus.~   "
213177|NCT00769717|"~     For over four decades the medical literature has observed a relationship between obesity and~     poorer health outcomes. The causal mechanisms of these poorer outcomes however are unclear.~     One assumption that has been supported by correlational data is that increased weight is~     associated with increased cardiovascular disease (CVD) risk factors (i.e., hypertension,~     dyslipidemia, and type 2 diabetes). Consequently, obese people are routinely prescribed~     weight loss programs in order to prevent or control these conditions. Unfortunately, long~     term weight loss has been met with minimal success for the large majority of people.~     Furthermore, the data suggesting that weight loss leads to long term health benefits and~     decreased mortality is limited and contradictory. The purpose of the proposed project is to~     perform a randomized controlled pilot study comparing the effectiveness of two lifestyle~     interventions for preventing CVD risk factors (hypertension, dyslipidemia, and type 2~     diabetes). The interventions are constitutionally similar; however, the treatment condition~     is a wellness-focused intervention that teaches healthy living without consideration of~     weight. The control condition is a traditional curriculum where the prescribed outcome is~     weight loss. The primary goals of both programs are to reduce hypertension and total~     cholesterol, and to enhance glucose control. Secondary outcomes of interest are psychological~     and behavioral in nature (e.g., self-esteem; depressed mood; anxiety; stress; quality of~     life; dietary habits; and physical activity). We will compare the trajectories of the CVD and~     psychological/behavioral risk factors for a total period of 24 months (including the time~     from baseline to the end of the 6-month intervention). Our objectives are to collect data to~     a) determine whether participants in both programs reduce CVD and psychological/behavioral~     risk factors at the completion of the 6-month program, and b) compare the persistency of~     health improvements and rate of relapse at the end of the 18-month follow-up period between~     the traditional weight loss intervention and the wellness-focused intervention.~   "
213178|NCT00769704|"~     The objective of this study is to evaluate the efficacy and safety of treatment with~     talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with~     unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim~     to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as~     compared to GM-CSF.~   "
213182|NCT00769652|"~     This is a two-part study. Part I is an observational study. Part II is a randomized clinical~     trial to see how well medical nutrition therapy works compared with standard care in treating~     patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer.~   "
213183|NCT00769626|"~     The purpose of this study is to compare the clinical outcomes and costs associated with two~     different management strategies for patients with acute low back pain who consult their~     primary care physician. The investigators hypothesize that management using a brief,~     standardized physical therapy intervention will result in better outcomes than management~     based on current practice guideline recommendations of watchful waiting for the first 4 weeks~     following consultation.~   "
213184|NCT00769613|"~     RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are~     infected with cytomegalovirus.~      PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients~     who have undergone donor stem cell transplant and have cytomegalovirus infections.~   "
213185|NCT00769600|"~     Primary Objectives~      To evaluate the 3-month event-free survival of the combination of the combination of~     itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.~      Secondary Objectives~      To determine the objective response rate of the combination of itraconazole and pemetrexed in~     patients with recurrent/refractory non-small cell lung cancer.~   "
213186|NCT00769587|"~     RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to~     the disease.~      PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with~     relapsed or progressive systemic mastocytosis.~   "
213187|NCT00769574|"~     To assess diagnostic and prognostic value of new biomarkers in patients admitted for~     suspicion of non ST elevation acute coronary syndrome (NSTE ACS).~   "
213188|NCT00769561|"~     The purpose of this study is to develop and evaluate a biofeedback-based cognitive behavioral~     treatment for patients with chronic temporomandibular disorders using a randomized controlled~     design.~   "
213189|NCT00769548|"~     RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Hormone therapy~     combined with radiation therapy may be a more effective treatment for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of four different~     combinations of radiation and hormone therapy in treating patients with prostate cancer.~   "
213190|NCT00769535|"~     Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with~     hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by~     PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those~     with polymorphism and those without.~   "
213191|NCT00769522|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and~     bendamustine, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can~     block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. It is not yet known whether giving fludarabine and cyclophosphamide together with~     rituximab is more effective than giving bendamustine together with rituximab in treating~     chronic lymphocytic leukemia.~      PURPOSE: This randomized phase III trial is studying fludarabine, cyclophosphamide, and~     rituximab to see how well they work compared with bendamustine and rituximab in treating~     patients with previously untreated B-cell chronic lymphocytic leukemia.~   "
213192|NCT00769509|"~     The goal of this study is verify if the energy expenditure in preterm infant fed with human~     milk is different from preterm formula. A randomized, controlled, crossover, double blind~     clinical trial will be carried out in which the newborn will be its own control.~     Randomization will be according to the type of diet at the beginning of the study. Half of~     the participants will be randomly assigned to begin the study using one type of milk (for~     example, human milk) and later another type of milk (preterm infant formula) and the other~     half will do the opposite.~   "
213193|NCT00769496|"~     A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients~     undergoing hemodialysis~   "
213194|NCT00769483|"~     Objectives:~      Primary Objectives:~        -  Phase I: Determine the maximal tolerated dose (MTD) of MK-0646 in combination with~          gemcitabine or gemcitabine plus erlotinib and recommended phase II dose.~        -  Phase II:~             -  Assess progression-free survival (PFS) with a) gemcitabine plus MK-0646 b)~               gemcitabine plus erlotinib plus MK-0646 and c) gemcitabine plus erlotinib.~             -  Explore IGF1 tissue level as a predictive biomarker for MK-0646 therapy in phase II~               expansion cohort.~      Secondary Objectives:~        -  Assess overall response rate (ORR), treatment toxicity, and overall survival (OS) with~          the addition of MK-0646 to gemcitabine or gemcitabine plus erlotinib.~        -  Correlate PFS and OS with IGF-1, IGFBP-3 levels and the expression of p-IRS, IGF-1R, EMT~          biomarkers, Akt, Erk, mTOR, and PI13k in tumor cells.~        -  To assess the incidence of single nucleotide polymorphisms of the IgF1R pathway related~          genes (IGF1, IGF1R, IRS1 and IRS2). These genotypes will be correlated with the clinical~          endpoints of this study, including OS, ORR and PFS.~   "
213195|NCT00769470|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether docetaxel and carboplatin are more effective when given together with trastuzumab~     and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer.~      PURPOSE: This randomized phase II trial is studying how well docetaxel and carboplatin work~     when given together with trastuzumab and/or lapatinib in treating women with stage I, stage~     II, or stage III breast cancer that can be removed by surgery.~   "
213243|NCT00768820|"~     The purpose of this study is to investigate the Psychiatric and Cognitive Phenotypes in~     Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome~     Characterization, Treatment and Examining the Connection to Developmental and Molecular~     Factors~   "
213196|NCT00769457|"~     Patients suffering from heart failure and a markedly reduced pumping capacity and sometimes~     desynchronization of the lower chambers of the heart have a higher risk of suffering sudden~     cardiac death.~      These patients can be treated with an Implantable Cardiac Defibrillator that terminates~     dangerously fast heartbeats and in case of asynchronous pumping of the heart can also~     re-synchronize the lower chambers of the heart (ICD- or CRT-D-system). Patients that moreover~     suffered from a worsening of their cardiac status (cardiac decompensation) and had to be~     hospitalized for this reason have a higher risc to have following decompensations. New~     technology, incorporated into modern Medtronic ICD- and CRT-D-Systems, that measures the~     amount of water in the lungs is able to warn before such a dangerous worsening occurs. If~     coupled with modern data transmitting technology (CareLink), automatic information in case of~     a worsening of the cardiac status can be sent to caregivers, who in turn can react timely in~     order to prevent a worsening an subsequent hospitalization.~      The study examines to which extent this new technology prevents potentially adverse cardiac~     situations and / or hospitalizations and has an influence of the duration of patient´s lives.~   "
213197|NCT00769431|"~     RATIONALE: Collecting feedback from patients with prostate cancer may help doctors develop~     better symptom management educational materials for patients.~      PURPOSE: This clinical trial is evaluating symptom management educational materials for~     patients with prostate cancer.~   "
213198|NCT00769418|"~     This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     once-daily multiple-dose administration of odanacatib (MK0822).~   "
213199|NCT00769405|"~     RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. It is not yet known whether systemic chemotherapy is more~     effective with or without intraperitoneal chemohyperthermia in treating patients with~     peritoneal carcinomatosis from colorectal cancer.~      PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it~     works compared with or without intraperitoneal chemohyperthermia in treating patients~     undergoing surgery for peritoneal carcinomatosis from colorectal cancer.~   "
213200|NCT00769392|"~     This study is designed to compare four currently used types of anesthesia used for~     intravitreal injection in order to evaluate the most effective method of anesthesia in~     reducing pain and discomfort associated with intravitreal injections.~   "
213201|NCT00769379|"~     This randomized phase III trial studies radiation therapy to see how well it works with or~     without trastuzumab in treating women with ductal carcinoma in situ who have undergone~     lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy~     x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective~     with or without trastuzumab in treating ductal carcinoma in situ.~   "
213202|NCT00769366|"~     Psychosocial factors play an important role in the pathophysiology of acute myocardial~     infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary~     treatment of AMI consisting of medical and interventional therapy.~      The investigators have designed a randomized, controlled study to assess the effects of~     short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an~     emergency percutaneous coronary intervention (PCI) post-AMI.~   "
213203|NCT00769353|"~     This research will examine the impact of brain activity, cognitive processing immune~     functioning, and gastrointestinal functioning on depressive symptoms and response to a~     psychotherapeutic intervention in youths with Inflammatory Bowel Disease (IBD).~   "
213204|NCT00769327|"~     RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib~     mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.~   "
213205|NCT00769314|"~     To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal~     tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.~   "
213206|NCT00769301|"~     The complexity of cancer patients' symptoms and health problems constitutes considerable~     distress and burden for patients and their family caregivers. To help them manage the illness~     effectively, there is a need to better understand the complexity of symptoms and symptom~     clusters in patients and caregivers. Therefore, the purpose of this research is to explore a~     set of important fundamental research questions to advance the scientific knowledge of cancer~     patients' and caregivers' symptoms, symptom clusters and health-related quality of life. The~     investigators will follow 500 cancer patients and their caregivers with repeated measures~     over 6 months to assess their symptoms, symptom clusters, and quality of life over time.~     Caregiver burden will also be examined in the caregivers.~   "
213207|NCT00769288|"~     Drugs used in chemotherapy, such as FAU, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. This phase I trial is~     studying the side effects and best dose of FAU in treating patients with advanced solid~     tumors or lymphoma.~   "
213208|NCT00769275|"~     Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with~     Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5~     years for the occurrence of cardiac death or non-fatal myocardial infarction.~      The aims are:~        1. To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic~          subjects with Type 2 Diabetes Mellitus.~        2. To identify on the basis of clinical and/or biochemical variables in a high-risk cohort~          in which screening for coronary artery disease is appropriate.~        3. To assess progression of (silent) myocardial ischemia after 3 years.~        4. To assess the occurence of cardiac death or nonfatal myocardial infarction during 5~          years follow-up in screened and not screened subjects.~   "
213244|NCT00768807|"~     The purpose of this study is to determine whether patients with obstructive sleep apnea have~     any changes in left ventricular function and structure after 06 months of continuous positive~     airway pressure treatment.~   "
213874|NCT00760409|"~     The purpose of this study is to determine if certain MRI imaging sequences (pictures) are~     more helpful to the physicians in determining if a brain tumor has recurred or if the person~     has radiation injury following their treatment.~   "
213209|NCT00769262|"~     Preterm newborns typically must be thermally regulated. In the United States, isolettes~     (incubators) are used to help them maintain their temperature. Traditionally, the temperature~     support (i.e. the temperature of the incubator) is decreased slowly according to NICU~     protocol until the baby is able to maintain its temperature in an open crib, without regard~     to the status of its feedings. This study will attempt to determine if there is a difference~     in length of stay, weight gain, and calories needed to gain appropriate weight between a~     group of newborns whose isolette temperatures are decreased in an aggressive strategy~     (isolette temperatures are decreased based only on baby's body temperature), and a group of~     newborns whose isolette temperatures are decreased in a conservative strategy (isolette~     temperatures are decreased to a minimum temperature and then kept steady until their feeds~     are at caloric goal and they are taking at least half of their feeds by mouth).~   "
213210|NCT00769249|"~     RATIONALE: Gathering information about the positive changes in quality of life of older~     patients with cancer and their care givers may help doctors learn more about the disease and~     plan better treatment.~      PURPOSE: This research study is looking at positive changes in the quality of life of older~     cancer patients and their caregivers.~   "
213211|NCT00769236|"~     We propose to study the intestinal secretion of ASCA by evaluating them in biopsy culture~     supernatants from a cohort of patients suffering from CD (n=80) and a cohort of control~     patients (UC (n=40) and patients without IBD (n=40 )).~   "
213212|NCT00769223|"~     RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA)~     level, and cancer stage from patients who have undergone radiation therapy for prostate~     cancer may help doctors predict how patients respond to treatment and help plan the best~     treatment.~      PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in~     predicting outcome in patients who have undergone radiation therapy for localized prostate~     cancer.~   "
213213|NCT00769210|"~     Our proposed research will examine whether treatment with simvastatin alters expression and~     activity of monocyte TF, whether polymorphisms in the TF gene alter the therapeutic effect~     and what effect treatment has on inflammatory markers in heart failure. The results of this~     study may assist in tailoring statin therapy to specific characteristics, such as~     inflammatory state, of heart failure patients. If treatment with simvastatin significantly~     lowers TF expression, this may reduce the risk of thromboembolic events in patients with~     heart failure, thus reducing mortality and morbidity. If the treatment effect varies based on~     the TF genotype, this may define an identifiable population in whom statin therapy may be~     more beneficial than the population as a whole.~   "
213214|NCT00769197|"~     Hypothesis: Children born prematurely (between 8 and 9 months) with brain damage have an~     abnormal appearance of the optic nerve (nerve in eye) that resembles glaucoma (cupping)~     compared to those born before 8 months.~      Purpose: to see how often children who are born prematurely and have suffered brain damage,~     have abnormal appearance of the optic nerve (nerve in the eye) which mimics glaucoma~     (cupping). This optic nerve cupping is most often seen when children are born after 8 months~     and is rarely seen in children born before 8 months.~      Children born prematurely are known to have injuries to their brain as they are not yet fully~     developed. This often involves the part of the brain that involves vision. Clinicians have~     observed that these children have an abnormal appearance of the optic nerve (nerve in the~     eye), which has the appearance of glaucoma. These children often undergo extensive and often~     unnecessary invasive tests to rule out glaucoma. The investigators wish to establish the~     prevalence of this abnormality so that children are not subjected to unnecessary~     investigations. The investigators also want to understand how the optic nerve cupping~     (similar clinical picture as glaucoma) is related to the approximate timing and extent of the~     brain injury, the type of cerebral palsy and the motor disability of these children.~   "
213215|NCT00769184|"~     This is a 12 week bilateral study, consisting of 6 weeks of treatment and 6 weeks of~     follow-up. The purpose of the study is to compare the safety and effectiveness of combining~     and then following a high potency topical corticosteroid treatment with LCD treatment for~     moderate-to-severe localized plaque psoriasis.~   "
213216|NCT00769171|"~     The purpose of this study is to assess the safety and efficacy of intravenous administration~     Moxifloxacin (BAY 12-8039) compared to intravenous ceftriaxone and metronidazole for the~     treatment of patients with complicated intra abdominal infections. In view of the fact that~     intra abdominal infections are typically polymicrobial and are often treated empirically, the~     selected antibacterial agent must cover the likely spectrum of bacterial pathogens.~     Combination antibiotics therapy has been widely used with great success.~   "
213217|NCT00769158|"~     We propose to conduct an inpatient pilot study to test the safety and potential efficacy of~     topiramate and naltrexone in combination for the treatment of alcoholism.~   "
213218|NCT00769145|"~     The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab~     given via subconjunctival injection in patients undergoing corneal transplantation.~   "
213219|NCT00769132|"~     The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER~     niacin, laropiprant, and placebo over the course of seven days on urinary levels of a~     metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.~   "
213220|NCT00769119|"~     The purpose of this study is to investigate if treatment with AZD9668 for 28 days is~     effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance~     which does not have any action).~   "
213221|NCT00769106|"~     Study hypothesis:~      The recurrence rate of HCC patients after radical resection is about 60-70%. This study is~     based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%.~      Abstract:~      This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who~     underwent radical resection will be included. The patients will be randomized to group A~     (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer~     treatment after resection of HCC, and the randomize ratio will be 1:1.~      Study treatment:~      Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver~     resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other~     supportive therapies are available in both groups.~   "
213291|NCT00768196|"~     The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with~     typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.~   "
213222|NCT00769093|"~     The purpose of this study is to learn more about imaging changes induced by a new therapeutic~     agent, bevacizumab with the standard steroid, dexamethasone in patients with high grade~     glioma. Magnetic resonance imaging (MRI) will be used to evaluate the difference between the~     2 treatments. The usual contrast agent (gadolinium) and an iron containing contrast agent~     called ferumoxytol may help us to evaluate the differences between bevacizumab and~     dexamethasone effects on imaging of a brain tumor called high grade glioma. For this purpose,~     after intravenous contrast agent injection, special MR scans (called: dynamic perfusion,~     blood-brain barrier (BBB) permeability measurement) will be performed to see the~     microvascular changes in the brain and tumor.~   "
213223|NCT00769080|"~     The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for~     postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment~     and Standard Treatment plus PSP arm after one year~   "
213224|NCT00769067|"~     This study will compare PF-00299804 given orally on continuous schedule to the approved drug,~     erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy;~     patients will be randomized to receive one of these drugs, and followed for efficacy and~     tolerance of each.~   "
213225|NCT00769054|"~     The purpose of this study is to compare systematic local infiltration with ropivacaine or~     placebo in patients undergoing repair of posterior vaginal wall prolapse.~      The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.~   "
213226|NCT00769041|"~     This study is to assess whether treatment with a therapeutic (100 mg) or supratherapeutic~     (800 mg) dose of avanafil has the potential to cause QT/QTc prolongation in healthy~     volunteers.~   "
213227|NCT00769028|"~     To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the~     treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation.~     The secondary objective of the study is to assess the efficacy of AIMSPRO as a therapeutic~     agent for SSc using inter alia the SSc-HAQ questionnaire and the modified Rodnan skin score.~   "
213228|NCT00769015|"~     This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL~     (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent~     depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative~     intervention, a low vision occupational therapist collaborates with a low vision optometrist~     to develop and implement a care plan based on a subject's vision status, rehabilitation~     potential, and personal rehabilitation goals. An independent rater masked to treatment~     assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and~     targeted vision function and vision-related quality of life (secondary outcomes) at baseline~     and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months~     to evaluate long-term effects.~   "
213229|NCT00769002|"~     This study is being done to learn how previous flu vaccination or previous infection with flu~     virus affects the immune response to vaccination.~   "
213230|NCT00768989|"~     The purpose of this study is to determine if the combination of atazanavir and raltegravir~     taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).~   "
213231|NCT00768976|"~     The primary objective of this study is to evaluate the quality of the clinical trial~     experience of cancer patients participating in cancer research studies through Summa Health~     System Hospitals Cancer Research Program by evaluating patient satisfaction regarding reasons~     for participating, facility, consent and treatment, personal issues and overall assessment.~      The secondary objective of this study is to determine areas for improvement to make the~     patient's clinical trial experience a satisfying and positive journey.~   "
213232|NCT00768963|"~     The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab~     given via subconjunctival injection in patients undergoing pterygium surgery.~   "
213233|NCT00768950|"~     Up to 60% of patients with Seronegative Spondyloarthritides have inflammation in the colon or~     ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will~     develop. Lesions of the bowel could also be present in the SA patients because of the~     potential injury posed by the NSAIDS, a common used medication in this setting.~      It is the bowel involvement in patients with SA that we propose to characterize, partly~     because there are scant communicated data in the medical literature, especially regarding~     small bowel lesions.~   "
213234|NCT00768937|"~     Hepatocellular carcinoma (HCC) as the third most common cause of cancer-related death has a~     very poor prognosis. Aim of this open label single arm non randomized pilot trial is the~     evaluation of the efficacy and safety of sorafenib in combination with TACE in patients with~     unresectable HCC. Efficacy ad safety will be compared with a historical TACE-only group of a~     placebo controlled TACE-trial.~   "
213235|NCT00768924|"~     The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium~     phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads~     of various sizes for surgical implantation. Pre-clinical animal studies suggest that the bone~     healing strength of CopiOs to be equivalent to autograft.~   "
213236|NCT00768911|"~     Rationale:~      In light of the demonstrated activity of anti-angiogenesis agents in rGBM, it is reasonable~     to postulate that adding these agents to standard RT and chemotherapy in the up-front~     management of newly diagnosed GBM may improve the clinical benefit. This study will examine~     the safety and tolerability of adding CT-322 to the standard radiation therapy/temozolomide~     (RT/TMZ) backbone of treatment for newly diagnosed GBM~   "
213237|NCT00768898|"~     The purpose of this study is to determine the correct volume of lissamine green to use when~     assessing conjunctival staining, and to determine the time course needed to evaluate~     conjunctival staining after lissamine green has been instilled in the eye.~   "
213238|NCT00768885|"~     To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.~   "
213239|NCT00768872|"~     The purpose of this study is to characterize a patient's activity levels before and after~     spinal cord stimulation therapy.~   "
213240|NCT00768859|"~     To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as~     neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer~   "
213241|NCT00768846|"~     The zotarolimus-eluting Endeavor Resolute stent is not inferior to the everolimus- eluting~     Xience V stent platform regarding a composite of cardiac death, myocardial infarction or~     target lesion revascularisation in a real-world population.~   "
213245|NCT00768794|"~     The purpose of this study is to determine the effectiveness of using acidophilus to treat~     oral candidiasis (thrush) caused by radiation therapy to the head and neck region.~      This study will conducted in two parts. In the first part of the study, two participants will~     begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy,~     white/yellow coating and/or patches on the tongue and inside of your mouth that are painful,~     you will begin taking acidophilus capsules twice each day until the last day of radiation~     therapy.~      The second part of the study is to determine if acidophilus is effective in preventing oral~     candidiasis (thrush) during radiation therapy to the head and neck region. In the second part~     of the study three participants will take acidophilus capsules twice each day beginning on~     the first day of radiation therapy and continuing until the last day of radiation therapy.~   "
213246|NCT00768781|"~     The overall goal of this project is to evaluate the evidence for the efficacy of two~     mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and~     mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among~     individuals with psychophysiological insomnia.~      Specific Aim 1: To obtain evidence for the relative effects of MBT-I and MBSR compared to a~     delayed-treatment control condition followed by behavior therapy for insomnia (BT-I) on~     arousal levels. It is hypothesized that MBSR and MBT-I will be superior to the control~     condition at reducing arousal levels.~      Specific Aim 2: To obtain evidence for the relative effects of MBT-I, MBSR, and the~     delayed-treatment control on sleep. It is hypothesized that MBT-I will be superior to the~     MBSR and control conditions at improving sleep parameters.~      Specific Aim 3: To investigate the relationship between measures of arousal (self-report and~     objective measures) and sleep (self-report and objective measures) to enhance the~     understanding of the role of arousal in psychophysiological insomnia.~   "
213247|NCT00768768|"~     Terbinafine is recognized as one of the most effective drugs for the treatment of toe nail~     fungus (onychomycosis). This trial will be the first test of a new device to improve the~     delivery of terbinafine directly to the toe nail. The device uses a low level of electric~     current, iontophoresis, to push the terbinafine into the nail.~      The study will involve a single application of terbinafine, in a gel form, with the~     iontophoretic device. The treatment will be applied to the surface of both large toenails of~     healthy subjects. Subjects will be asked to report any sensations in the nail or surrounding~     skin experienced during or after treatment. Samples from the edge of the treated toe nail~     will be taken at 2-4 week intervals to measure how much terbinafine was delivered to the~     nails, and blood samples will be taken for the first 24 hours after treatment to determine~     how much, if any, terbinafine was absorbed into the subjects's body. Observations will also~     be made of the treated toes to look for any irritation of the surrounding skin due to the~     treatment.~   "
213248|NCT00768755|"~     AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as~     first-line treatment of patients with locally advanced, recurrent, or metastatic~     non-squamous, non small cell lung cancer (NSCLC).~   "
213249|NCT00768742|"~     The primary objective of this study is to test the hypothesis that a minimum 75% volume~     radiofrequency ablation of fibroids associated with menorrhagia results in reduction of~     menstrual bleeding.~   "
213250|NCT00768729|"~     Kidney transplantation is widely considered to be the treatment of choice for children with~     End Stage Renal Disease (ESRD). The purpose of this study is to determine the safety of~     sirolimus monotherapy for long-term immunosuppression in children and adolescents after~     kidney transplantation.~   "
213251|NCT00768716|"~     Although acetaminophen is the most commonly used nonprescription drug in the USA, little is~     known regarding the influence of genes and race/ethnicity on acetaminophen disposition. The~     investigators long-term goal is to understand the causes of differences in acetaminophen~     disposition between people that are the result of genetic variation and ethnicity and may~     predispose individuals to a higher risk of acetaminophen hepatotoxicity. The aim of this~     particular study is to measure the rate of elimination of acetaminophen via the 3 main~     pathways (glucuronidation, sulfation and oxidation) in self-identified White-Americans~     (n=100) and African-Americans (n=100). These rates will then be correlated with selected~     genetic polymorphisms in genes encoding enzymes involved in acetaminophen metabolism. Two~     main hypotheses will be tested: 1. African-Americans eliminate acetaminophen more rapidly by~     glucuronidation than do White-Americans. 2. Elimination via glucuronidation, sulfation, and~     oxidation in subjects will be significantly correlated with the presence of polymorphisms in~     the UGT1A6, SULT1A1, and CYP2E1 genes, respectively.~   "
213252|NCT00768703|"~     Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of~     the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm.~     Herniation of viscera into the chest prevents the fetal lungs from developing and growing to~     normal size. In the most severe cases, there is significant morbidity and mortality at birth.~     For these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow~     enough in utero that they are capable of sustaining life after birth. This unblinded,~     non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon~     and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat~     severe CDH in utero. The primary outcome variable will be fetal lung growth due to successful~     'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (LHR)~     measurements. Secondary outcome variables include maternal, fetal and neonatal variables,~     specifically neonatal survival at 90 days of life. For infants who survive beyond 90 days~     post-delivery, their families will be offered follow-up (up to 2 years of age and possibly~     beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at UCSF.~   "
213253|NCT00768690|"~     The purpose of this study is to determine multiple dose safety, tolerability and~     pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to~     determine the effect of single dose administration of ketoconazole on steady state ABT-333~     pharmacokinetics~   "
213254|NCT00768677|"~     This is a study of topiramate to see whether topiramate decreases binge eating behavior among~     adolescents and young adults. The investigators did also checked whether topiramate affected~     cognitive function or not.~   "
213255|NCT00768664|"~     This study will investigate the safety and efficacy of oral PF-00299804 in patients who have~     not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck~     squamous cell cancer.~   "
213256|NCT00768651|"~     We aim to study if the administration of medications to increase the secretion of hormones~     from the intestines can improve glycemic control, reduce insulin use and promote β-cell~     regeneration/expansion in subjects with type 1 diabetes following islet transplantation who~     are back using small doses of insulin because of early graft dysfunction. We believe that the~     results will enable us to understand whether these drugs could be useful in islet transplant~     recipients, particularly if glycemic control deteriorates.~   "
213257|NCT00768638|"~     Randomized controlled double blind study of parallel groups to evaluate the comparative~     effects of low-dose of atorvastatin on proteinuria in patients with stage 3 or 4 chronic~     kidney disease.~   "
213258|NCT00768625|"~     The purpose of this study is:~        1. To determine the frequency of cardiovascular diseases in patients with OSA, obese,~          overweight, and lean (BMI<25)~        2. To analyze the CPAP treatment over the clinical evolution of OSA patients~        3. To determine if OSA is a independent predictor of cardiovascular risk~   "
213259|NCT00768612|"~     This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese~     subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also~     assess the efficacy of vabicaserin and compare it to risperidone.~   "
213260|NCT00768599|"~     This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up~     period) of a topical foam to treat athlete's foot. The active ingredient in the foam --~     econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your~     doctor can currently prescribe to treat athlete's foot. This study will help to understand if~     the foam works the same as the cream to treat athlete's foot.~   "
213261|NCT00768586|"~     The aim of this study is to collect data on the early visual development of extreme premature~     infants. The method is the measurement of flash visual evoked potentials and the study~     population includes premature infants under the 28th weeks of gestation, who have normal~     cranial ultrasound examinations, normal aEEG, no clinical neurological symptoms and who have~     a normal ophthalmological status.~      fVEP measurements were recorded from the first week of life every second week until term.~      The fVEP recordings were performed in active sleep, in stable premature infants, who were~     continuously monitored. The Nihon Kohden Neuropack 8 was used, the stimulus frequency was 0,5~     Hz, artefact free averages were analyzed.~      The measurements were analyzed according to the presence and absence of known waveforms,~     their latencies and amplitudes. Longitudinal analysis was performed to analyse the effect of~     extrauterine visual development on fVEP with growing gestational ages.~   "
213262|NCT00768573|"~     taste of formulation~   "
213263|NCT00768560|"~     This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who~     meet the entry criteria will be required to stop taking any other anti-hypertensive agents~     than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label~     Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those~     who are confirmed with their eligibility as subjects for the present study at the end of the~     baseline treatment period will be randomly allocated to one of the 6 treatment sequences on~     the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg~     OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks~     per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR~     tablet 40 mg and its placebo as follows (Double-blind treatment period).~   "
213264|NCT00768547|"~     The study has three main parts.~        1. To see if we can develop a riskstratification tool that can be used to asses the risk~          for acutely admitted medical patients for inhospital death, admission to the ICU and~          death within 30 days of release.~        2. To test existing tool as in 1.~        3. To clarify if it is most reasonable to let the admitting doctor order blood test by~          clinical judgment or be using a predefined list of tests.~   "
213265|NCT00768534|"~     Describe the patient population and bacterial microbiology of pediatric patients presenting~     with spontaneous draining acute otitis media~   "
213266|NCT00768521|"~     This study will design an alternative urodynamic platform to better evaluate treatment~     effects of medications for overactive bladder. Part II is dependent on results of Part I and~     may not be conducted.~   "
213267|NCT00768508|"~     This study would like to test whether the combination of ondansetron and naltrexone will be~     superior to either medication alone or placebo in the treatment of alcohol dependence.~   "
213268|NCT00768495|"~     This trial will collect tissue oxygenation data via hyperspectral imaging before and after~     endovascular procedures.~   "
213269|NCT00768482|"~     This study will measure the amount of buprenorphine found in the blood after taking~     sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine~     implants).~   "
213270|NCT00768469|"~     This is an open-label, phase 1 study of ascending multiple oral doses of HKI-272 in~     combination with paclitaxel.~   "
213271|NCT00768456|"~     The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 %~     vs. Placebo in patients undergoing vaginal hysterectomy.~      The hypothesis is that systematic local infiltration will reduce postoperative pain and~     postoperative opioid consumption.~   "
213272|NCT00768443|"~     This a non-interventional multi-centre study to evaluate the symptom load and management~     strategies in PPI-treated GERD patients with persistent GERD symptoms..~   "
213273|NCT00768430|"~     Existing treatments for major depressive disorder (MDD) generally take weeks to months to~     exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for~     MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has~     been used as a standard intravenous (IV) anesthetic agent for many years in both pediatric~     and adult patients. Beyond its well-established role in anesthesia and pain management, there~     is emerging evidence that ketamine may have rapid antidepressant properties for patients with~     severe mood disorders.~      In this study we are investigating whether ketamine can have an antidepressant effect~     compared to midazolam. Midazolam has similar anesthetic effects compared to ketamine but has~     not been shown to be an antidepressant, and is therefore acting as an active control in this~     study.~      The study period can last up to 8 weeks, depending on your response to the study medication.~     There are two required overnight stays in our Research Commons as part of this study.~   "
213347|NCT00767442|"~     Evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy~   "
213274|NCT00768417|"~     Evidence indicates that almond consumption is associated with multiple health benefits.~     However, nuts are commonly excluded from diets on the basis that their high energy content~     may induce weight gain. Evidence from numerous studies show that this is not the case, yet~     the mechanism responsible for the less than predicted effect on weight is unknown. This study~     aimed to examine the effects of increased mastication on lipid bioavailability and satiety~     related peptide released in humans. Its purpose is to provide valuable mechanistic data to~     support the results from previous completed clinical studies.~   "
213275|NCT00768404|"~     VI-0521, a fixed dose combination of immediate-release (IR) phentermine and~     controlled-release (CR) topiramate, is in Phase III clinical development as a potential~     therapy for obesity. In human, both phentermine and topiramate are primarily cleared by renal~     excretion. The contribution of hepatic metabolism to elimination of phentermine and~     topiramate is not significant. Obese patients, the proposed indicated population for future~     treatment with VI-0521, are likely to have renal impairment. Therefore, this study is~     important in understanding the effect of renal impairment on the pharmacokinetics of~     topiramate and phentermine in subjects with renal impairment compared to subjects with normal~     renal function.~   "
213276|NCT00768391|"~     The purpose of this study is to determine if IMC-3G3 is safe for patients, and also to~     determine the best dose of IMC-3G3 to give to patients.~   "
213277|NCT00768378|"~     The purpose of this study is to assess the safety and efficacy of the BrainPort balance~     device in improving balance and gait as measured by clinically accepted standardized balance~     assessments in subjects with peripheral vestibular dysfunction.~   "
213278|NCT00768365|"~     Between September 2006 and September 2008, 35 patients (32 women and 3 men; mean age 49years~     with adrenal incidentaloma (AI) were prospectively evaluated at the Department of~     Endocrinology and General Surgery of Istanbul University, Istanbul Medical Faculty.~      All patients with AI underwent physical examination, including waist circumference. Body mass~     Index (BMI) was calculated as weight (kg)/ height (m) squared. A BMI > 30 was considered an~     index of obesity. A waist circumference > 88 cm in women and > 95 cm in men was considered~     the cutoff for visceral obesity in accordance to the Adult Treatment Panel III (ATP III)~     metabolic syndrome criteria. Systolic blood pressure (SBP) and diastolic blood pressure (DBP)~     were measured from the right brachial artery of the patients in a supine position after 10~     minutes of rest by using a pneumatic sphygmomanometer by the same doctor.~   "
213279|NCT00768352|"~     The purpose of this study is: 1) to assess pediatric resident knowledge of adolescent mental~     health; 2) to assess pediatric resident comfort level for screening, assessing, and treating~     mental health disorders in adolescents, and; 3) to evaluate pediatric resident current~     practices for adolescent mental health screening, assessment, and treatment.~   "
213280|NCT00768339|"~     AEG35156 has shown early evidence of activity in patients with advanced indolent B-cell~     lymphomas in Phase 1 trials and merits further evaluation in this disease. This trial is~     designed to determine the recommended dose of AEG35156 in patients with relapsed or~     refractory chronic lymphocytic leukemia (CLL) and indolent B-cell lymphomas.~   "
213281|NCT00768326|"~     The main purpose with the study is to evaluate the efficacy and safety of Lu 31-130 in~     patients suffering from schizophrenia compared to placebo.~   "
213282|NCT00768313|"~     There has been a growing trend amongst surgeons to use a construct for correction of~     scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw~     proponents cite greater curve control in all planes, which results in improved spinal curve~     correction. Some surgeons have noted due to the increased strength of the all screw~     construction that the rod is now the weak part of the spinal fixation. Although no evidence~     has been raised in regards to hardware failure there is a perception that a loss of balance~     in the sagittal plane is the result of flex in the titanium rod. A novel solution to the~     issue of rod flexibility is raised with the expedium super steel instrumentation which allows~     for greater stiffness than a 5.5 mm titanium rod with the same lower profile. This study aims~     to compare the new super steel technology with other established instrumentations used to~     correct spinal stenosis.~   "
213283|NCT00768300|"~     The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying~     disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to~     evaluate its safety, and to evaluate its effect on development of pulmonary hypertension,~     quality of life, and dyspnea (shortness of breath) symptoms in this participant population.~     Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively.~     Participation in the study was to be up to 4 years, depending on how long it would take to~     enroll participants and observe study events. After randomization, visits to the clinic took~     place every 3 months, and laboratory procedures were performed every month.~   "
213284|NCT00768287|"~     To evaluate the safety (acute effects associated with infusions, and inhibitor development),~     pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis~     and with respect to control of hemorrhaging in both the prophylaxis and on demand groups of~     IB1001 in subjects with hemophilia B.~   "
213285|NCT00768274|"~     The purpose of this study is to investigate an oral formulation of RVX000222 for safety,~     pharmacokinetic and efficacy in healthy subjects.~   "
213286|NCT00768261|"~     The overall purpose of this research is to determine if there is a relationship between your~     symptoms of Dementia of the Alzheimers type and changes in the size and shape of certain~     brain structures during combined Donepezil (Aricept®) and Memantine (Namenda®) treatment.~   "
213287|NCT00768248|"~     The purpose of this research study is to determine if putting local anesthetic—or numbing~     medication—through one or two tiny tube(s) placed next to the nerves that go to an amputated~     limb will decrease phantom limb and/or stump pain.~   "
213288|NCT00768235|"~     This study tested the hypothesis that yoga practice can improve respiratory function in the~     elderly.~   "
213289|NCT00768222|"~     This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in~     approximately 100 patients from 6 centers in China undergoing scheduled modified radical~     mastectomy for breast cancer.~   "
213290|NCT00768209|"~     This study is designed to determine the effects of a single dose of the study medication in~     subjects with and without hepatic impairment. 18 to 24 subjects will participate by having~     multiple blood draws taken to measure the level of study medication in their blood over time.~   "
213292|NCT00768183|"~     The objective of this study was to compare the single-dose relative bioavailability of~     Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release~     capsules when dosed with alcohol under fasting and fed conditions compared to water.~      In addition, the pharmacokinetics of an immediate release solution following a 20 mg dose was~     assessed for informational purposes and for possible modeling.~   "
213293|NCT00768170|"~     This study evaluates the safety, tolerability and pharmacokinetics (PK) of MK0633 in~     adolescent mild-to-moderate Japanese asthma patients to permit further clinical investigation~   "
213294|NCT00768157|"~     Most hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that~     anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma.~   "
213295|NCT00768144|"~     The purpose of this study is to determine the effectiveness of sunitinib on participants with~     ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may~     stop cancer cells from growing by blocking the blood supply to the tumor.~   "
213296|NCT00768131|"~     The purpose of this study is to determine if EGFR status (positive or negative) by FISH can~     predict response to cetuximab therapy in NSCLC patients treated with carboplatin and~     paclitaxel~   "
213297|NCT00768118|"~     RATIONALE: Studying samples of blood and urine from healthy participants receiving~     antioxidant nutritional supplements may help doctors identify changes in biomarkers related~     to oxidative stress.~      PURPOSE: This clinical trial is studying how well a nutritional supplement capsule containing~     curcumin, green tea extract, Polygonum cuspidatum extract, and soybean extract works in~     healthy participants.~   "
213298|NCT00768105|"~     The purpose of this study is to assess safety and tolerability of AZD1656 after multiple~     repeated oral doses in patients with type 2 diabetes on top of insulin.~   "
213299|NCT00768079|"~     The study will evaluate the effect of two IV dose regimens of MEDI-563 on the proportion of~     adult subjects with asthma exacerbations who required an urgent healthcare visit for~     treatment of an acute asthma exacerbation.~   "
213300|NCT00768066|"~     The technique of transplanting progenitor cells into a region of damaged myocardium, termed~     cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or~     repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily~     available, easy to culture to ensure adequate quantities for transplantation, and able to~     survive in host myocardium; often a hostile environment of limited blood supply and~     immunorejection. Whether effective cellular regenerative strategies require that administered~     cells differentiate into adult cardiomyocytes and couple electromechanically with the~     surrounding myocardium is increasingly controversial, and recent evidence suggests that this~     may not be required for effective cardiac repair. Most importantly, transplantation of graft~     cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a~     number of candidate cells have been transplanted in experimental models, including fetal and~     neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile~     grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac~     precursors residing within the heart itself. There has been substantial clinical development~     in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both~     post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and~     heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also~     been studies clinically.~      Currently, bone marrow or bone marrow-derived cells represent highly promising modality for~     cardiac repair. The totality of evidence from trials investigating autologous whole bone~     marrow infusions into patients following myocardial infarction supports the safety of this~     approach. In terms of efficacy, increases in ejection fraction are reported in the majority~     of the trials.~      Chronic ischemic left ventricular dysfunction resulting from heart disease is a common and~     problematic condition; definitive therapy in the form of heart transplantation is available~     to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart~     failure has been studied less than for acute MI, but represents a potentially important~     alternative for this disease.~   "
213301|NCT00768053|"~     The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses~     certain criteria, including joint counts and patient perceived disease activity, to measure~     disease activity in people with Rheumatoid Arthritis . More recently, the European League~     against Rheumatism (EULAR) has developed a new system of measurement known as the Rheumatoid~     Arthritis Impact of Disease score, or EULAR-RAID score. The EULAR-RAID score is a composite~     score based on patient reported outcomes, and includes such criteria as pain, functional~     disability, fatigue, sleep disturbances, coping, overall assessment of physical well being~     and overall assessment of psychological well being. The objective of this study is to~     evaluate the practical modalities and performance of the EULAR- RAID score in patients with~     rheumatoid arthritis who have been prescribed etanercept as part of usual medical practice.~   "
213302|NCT00768040|"~     To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema~   "
213303|NCT00768027|"~     The objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate~     wound healing progression using a new hyperspectral imaging technology.~   "
213304|NCT00768014|"~     The purposes of this study is to integrate the objective tests into the subjective test,~     visual analog score (VAS), for evaluation and further understanding of relieving labor pain~     by TENS application on acupuncture points in the first stage of labor.~   "
213305|NCT00768001|"~     Liver cancer is a leading cause of cancer deaths worldwide. While the molecular pathogenesis~     of liver cancer has been extensively studied, less is known about how the molecular biology~     of liver cancer influences clinical outcome and treatment response. We are developing a~     translational research program that will characterize molecular changes in liver cancer. We~     plan to use molecular information obtained from studying liver tumor tissues to develop new~     diagnostics and treatment regimens for patients with these cancers. The experimental approach~     will require freezing fresh tumor tissues obtained from surgical procedures, which will be~     subsequently used for analysis of DNA, protein and mRNA expression. Many patients with liver~     cancer are referred to the Stanford Liver Tumor Board for consultation and treatment~     recommendations. We propose to gather tissue samples from those who subsequently undergo~     biopsy, liver resection surgery, or transplant surgery.~   "
213348|NCT00767429|"~     Because the increasing fall problem, mainly due to an impaired gait and balance ability, this~     study will investigate fall risk by detecting fall related movement characteristics. Based on~     the promising results using accelerometry for accurate and objective gait analysis, fall risk~     will be measured using a triaxial accelerometer.~      At the moment our group is performing a study titled 'identify subjects at risk for falling~     using accelerometry'. In this study, fall related movement characteristics (gait, balance,~     stumble reaction) are identified in healthy younger and older subjects under standardised~     laboratory circumstances. In this way, specific characteristics can be selected which are~     responsible for fall risk.~      The aim of this study is investigating if the acceleration based fall risk detector can be~     applied in daily life with target groups.~   "
213306|NCT00767988|"~     Girls with spina bifida also have bladder problems. This is because they need temporary~     placement of a tube into the bladder to remove urine. This thin flexible tube is called a~     catheter. It can increase the risk of having bacteria in the urine. This in turn can lead to~     urinary tract infection (UTI).~      Some girls with spina bifida are given antibiotics. These are medicines used to treat~     infections caused by bacteria. The medicine is used to prevent UTI. However, long-term~     treatment with these medicines can have side effects. For example, the bacteria may become~     resistant to the antibiotics. Also, bacteria in the urine can persist. UTI can still occur in~     patients on antibiotics.~      UTI in girls occurs because bacteria migrate from the rectum to the vagina area. This gives~     the bacteria access to the bladder. Also, in girls with spina bifida, the access to the~     bladder is easier because of the catheter.~      Probiotics are friendly bacteria. They are available as dietary supplements and as food. They~     contain helpful bacteria. Yogurt is an example of a food that contains probiotics.~      The purpose of this study is to find out, if probiotics taken for 6 months can prevent UTI in~     girls with spina bifida. We will also try to find out whether changes in urine bacteria are~     associated with the taking of the probiotics. A vaginal and rectal swab will also be done to~     find out if taking probiotics has any benefits on preventing bacteria.~   "
213307|NCT00767975|"~     LTBI Treatment is effective in prison~   "
213308|NCT00767962|"~     Treatment of recurrent primary spontaneous pneumothorax remains controversial and many~     therapeutic options exist. The aim of this study is to compare pleural symphysis by talc~     poudrage during medical thoracoscopy and surgical management combining pleural abrasion and~     blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.~   "
213309|NCT00767949|"~     Age-related macular degeneration (AMD) is a disease that, in time, destroys the macula, which~     is the central part of the retina that gives sharp central vision. The primary purpose of~     this study is to assess the safety of iSONEP which is a humanized monoclonal antibody against~     a bioactive lipid, sphingosine 1-phosphate (S1P).~   "
213310|NCT00767936|"~     Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk~     factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to~     sequence the HBV genome in patients with chronic HBV infection, and in patients with liver~     cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV~     genome that predisposes these high risk individuals to the development of liver cancer.~   "
213311|NCT00767923|"~     Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level~     amputation because of critical limb ischemia, infection, or tissue necrosis.~   "
213312|NCT00767897|"~     The proposed study is a pilot study and a first step towards developing an optimized HPV~     vaccination strategy for girls who have CKD, or are on dialysis or have a kidney transplant.~   "
213313|NCT00767884|"~     The purpose of this study is to evaluate the optic nerve head changes consequent to~     panretinal photocoagulation done for diabetic retinopathy.~   "
213314|NCT00767871|"~     Panic disorder is one of the most prevalent psychiatric disorders and recently abnormal fear~     network is known to be implicated in the pathophysiology of panic disorder. The fear network~     involves many brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus~     coeruleus, parahippocampal gyrus, frontal cortex, and thalamus. Escitalopram, a highly~     selective serotonin reuptake inhibitor, is usually effective for panic dis order, but there~     is little information on how escitalopram affects the fear network.~      The specific aim of this study is to test the following hypotheses using 18F-FDG positron~     emission tomography (PET)~        1. Patients with panic disorder will show abnormal activity of the fear network compared to~          healthy comparison subjects.~        2. Patients with panic disorder will show normalized activity of the fear network after~          12-weeks of treatment with escitalopram.~        3. The changes of fear work after the treatment will be associated with psychological~          variables and neurohormones.~   "
213315|NCT00767858|"~     This study will explore how cultural differences influence genetics research in developing~     countries. Human genetics research is becoming more common in developing countries. However,~     when research is conducted with people living in developing countries, there is a chance that~     culture differences can lead to misunderstandings between investigators and participants,~     resulting in ineffective research. This study will explore challenges facing investigators~     conducting genetics research in developing countries and opportunities to improve this kind~     of research.~      Scientists who have conducted genetics research in a developing country may be eligible to~     participate in this study. Participants are interviewed by telephone. The interview, which~     lasts about an hour, includes questions about the researchers decision to conduct the study~     they have done, the times they noticed that culture played a role in the research and the~     times that were more challenging and less challenging.~      The interviews are recorded, transcribed and analyzed for themes related to cultural~     congruence and specific challenges and opportunities with regard to cultural congruence.~   "
213316|NCT00767845|"~     RATIONALE: Gathering information about symptom management from patients with localized~     prostate cancer may help doctors improve patients' quality of life.~      PURPOSE: This clinical trial is studying symptom management in African-American men with~     localized prostate cancer.~   "
213317|NCT00767832|"~     The purpose of the study is to assess the coagulation changes that occur in patients~     undergoing elective Cesarean delivery using thromboelastography (TEG). We will compare~     coagulation data to assess potential coagulation changes associated with hemoglobin changes~     before and after surgery, and related to estimated blood loss.~   "
213318|NCT00767819|"~     The purpose of this multicenter, two-arm, exact binomial single-stage, phase II trial is to~     determine the preliminary efficacy and safety of RAD001 in patients with histological~     evidence of progressive or metastatic bone or soft tissue sarcoma.~   "
213319|NCT00767806|"~     The purpose of this study is to determine if duloxetine reduces the severity of chronic low~     back pain.~   "
213320|NCT00767793|"~     The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic~     solution.~   "
213321|NCT00767780|"~     The purpose of this study is to examine (retrospectively) the effect of a new biomechanical~     device on gait patterns of patients suffering from musculoskeletal disorders. The analysis is~     conducted on an existing database of the therapy center.~   "
213322|NCT00767767|"~     People often develop fearful responses to things, but have no conscious control over the~     fear. This is a basic form of unconscious memory, called fear conditioning. Intravenous~     anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they~     have similar effects on these unconscious fear memories.~      To address this question, the investigators will study 114 healthy adult volunteer subjects.~     The subject is given a very low dose of an anesthetic drug intravenously (i.e. through the~     bloodstream). The dose is so low that the subject might not even be able tell if they are~     getting the drug. While they are receiving the drug, the subject will perform a series of~     memory tests and a fear conditioning experiment, which are set up like a very simple computer~     game. To create the fear response, subjects will occasionally receive a mildly~     uncomfortable shock to their arm. The subject is able to determine the highest level of shock~     that they will receive.~      The investigators are doing this study because the investigators wish to know exactly how the~     drugs affect the way people process fear and emotion. This knowledge might one day be used in~     the treatment of some psychiatric disorders.~   "
213323|NCT00767754|"~     Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain~     regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus,~     parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the~     pathophysiology and treatment outcome in panic disorder. Paroxetine has been used as primary~     agent for treatment of panic disorder but there is little information on how paroxetine~     affects the brain function in patients with panic disorder.~      The specific aim of this study is to examine the differences in brain activity between~     responders and nonresponders and to determine the predictor of paroxetine treatment in~     patients with panic disorder in terms of brain activity.~   "
213324|NCT00767741|"~     The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence~     on external and physiological alterations. We plan to compare the pharmacodynamics of insulin~     analog delivery in regular conditions and in the presence of increased perfusion of the~     delivery site, achieved by way of local warming and movement~   "
213325|NCT00767728|"~     The purpose of this study is to compare the maintenance of mild to moderate ulcerative~     colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day~     versus placebo.~   "
213326|NCT00767715|"~     The purpose of this study is to test the efficacy and total costs of olanzapine versus~     commonly used conventional antipsychotics in Sweden.~   "
213327|NCT00767702|"~     This study will explore scientists opinions and practices regarding the use of population~     descriptors (e.g., race, ethnicity, ancestry, geography and nationality) to describe a~     research study population. It will collect genetic researchers opinions, understandings and~     experiences studying human genetics and genetic variation.~      Scientists who are a principal investigator or co-principal investigator n a human genetic or~     genomic study of a common disease with at least preliminary data that uses population~     descriptors may be eligible for the study.~      Participants are asked to think about their study populations and how they are described in~     their research. They participate in two audio-taped semi-structured interviews that last from~     about 90 to 120 minutes. They may also participate in one or both of the following optional~     study components:~        -  A third semi-structured interview that explores implementing a new method of describing~          study populations in data analysis.~        -  2 to 3 days of lab observation, in which a member of the study research team meets the~          lab members, observes daily activities and attends lab meetings.~   "
213328|NCT00767689|"~     Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities.~     This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which~     is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome.~     patients , starting capecitabine chemotherapy for their cancer, will participate in this~     study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive~     either vitamin B6 or a placebo. investigators and patients will be blinded to the~     intervention.~   "
213329|NCT00767676|"~     Contact sensitization by patch applications.~   "
213330|NCT00767663|"~     In this study the investigators will investigate whether a short pretreatment (3-7 days) with~     dipyridamole 200mg twice daily will protect patients against myocardial injury sustained~     during an elective dotter operation of the coronary arteries (PCI).~      The investigators hypothesize that dipyridamole can reduce myocardial injury sustained during~     elective PCI.~   "
213331|NCT00767650|"~     This study will use neuropsychological tests to look at nervous system side effects of~     Cyclosporine (CsA) in patients with aplastic anemia. CsA is used as part of an~     immunosuppressive regimen in treating severe aplastic anemia. The drug can produce nervous~     system side effects, such as tremor and, less commonly, insomnia, anxiety, headache,~     confusion or seizures. This study will look at effects of CsA on intellectual ability,~     depression, anxiety, attention, concentration, memory, perception, coordination, and thought~     processing in patients~      Patients 15 years of age or older who have severe aplastic anemia may be eligible for this~     study if they:~        -  are co-enrolled in a Clinical Center protocol in which they will receive CsA~        -  have not taken CsA for 6 months before enrolling in this study~      Participants undergo neuropsychological testing. In addition, they provide blood samples and~     their clinical data are reviewed for things that may influence the interpretation of findings~     from the testing, such as results of blood tests, types of medications taken, number of~     transfusions required, etc. The procedures are as follows:~      Before first dose of cyclosporine:~        -  Patients are asked about prior problems with their nervous system, prior treatment for~          their aplastic anemia (including transfusions), prior infections, and current~          medications. They then complete the following sets of tests:~        -  Battery 1: A set of three tests that measure intellectual ability, level of depression~          (if any) and level of anxiety (if any).~        -  Battery 2: A set of seven tests that measure changes in the central nervous system and~          how these changes affect attention, concentration, memory, perception, coordination, and~          thought processing.~        -  Patients provide a half teaspoon of blood for this study at the same time blood is~          collected for their primary treatment protocol.~           6 months and 12 months after starting cyclosporine~        -  Patients are asked about treatment for their aplastic anemia (including transfusions),~          infections, and changes in medications that have occurred since they started taking~          cyclosporine. They then repeat the set of tests in Battery 2.~        -  Patients provide a half teaspoon of blood for this study at the same time blood is~          collected for their primary treatment protocol.~   "
213332|NCT00767637|"~     To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving~     dialysis~   "
213333|NCT00767624|"~     The aim of the proposed three-site study is to increase the rate of full remission from major~     depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both~     major depressive disorder and insomnia.~   "
213349|NCT00767416|"~     The primary objective of this study is to describe the 28-day post-final dose safety and~     tolerability of three doses of MEDI-559 at 10^5 FFU when administered to healthy RSV~     seronegative children 1 to <24 months of age.~   "
213350|NCT00767403|"~     This study will evaluate the effectiveness of an Internet intervention designed to reduce the~     behaviors and symptoms of pediatric encopresis.~   "
213334|NCT00767611|"~     Objectives:~      Male factor infertility is poorly understood and our ability to evaluate the male~     contribution to a couple's infertility is very limited. The overarching goal of this project~     is to understand at the molecular level what functional activities in human sperm are~     required for successful fertilization leading to full term development. These findings will~     allow us to develop new methods to determine the impact of environmental exposures on sperm~     quality and male fertility.~      A sperm protein known as phospholipase C zeta (PLC zeta) initiates embryo development at~     fertilization. The primary objective of this study is to test the hypothesis that human PLC~     zeta activity correlates directly with the proportion of fertilized eggs that undergo early~     cleavage during an in vitro fertilization (IVF) cycle. Secondary objectives for the study are~     to generate preliminary data regarding the variability in sperm PLC zeta activity within and~     between individuals and to determine if there are clinical or laboratory correlates for sperm~     PLC zeta activity.~      Study population:~      The study population will consist of 178 infertile couples undergoing IVF procedures at Duke~     Fertility Center (DFC) from which we will obtain 154 evaluable couples for the study.~      Overall Design:~      An observational cohort study design will be used to assess the association of PLC zeta~     activity in the residual sperm from the sample used for an IVF cycle with the proportion of~     eggs per couple that undergo early cleavage during the same cycle. Infertile couples~     enrolling in an IVF treatment cycle at DFC will be approached for inclusion in the study.~     Consent will be obtained from both male and female partners, and historical medical~     information and information about their IVF cycle will be collected by chart review. Blood~     for isolation of serum and DNA will be collected only from the male partner for evaluation of~     hormone levels and genetic analyses related to infertility. On the day of the egg retrieval,~     residual sperm not needed for clinical purposes will be transported via courier to NIEHS.~     Sperm PLC zeta activity will be measured in the investigator's laboratory using an~     experimental bioassay. Sperm PLC zeta protein will be analyzed at the University of~     Massachusetts.~      Outcome Parameters:~      The primary outcome will be the proportion of embryos that undergo early cleavage. Secondary~     outcomes will include proportion of eggs fertilized, embryo development parameters, and p...~   "
213335|NCT00767598|"~     In order to evaluate the effect of CYP3A5*3 allele on the pharmacokinetics of sildenafil,~     udenafil, and vardenafil, the clinical trial using a single oral dose was conducted in Korean~     healthy male subjects whose genotype of CYP3A5 had been determined.~   "
213336|NCT00767585|"~     The aim of this study is to determine the effect of aromatase inhibitors therapy on bone~     mineral density and compare it to the effects of tamoxifen and no hormonal therapy.~   "
213337|NCT00767572|"~     Coarctation of the aorta (CoA) accounts for approximately 8% of all congenital heart~     problems. Patients with CoA are well known to have an increased rates of early heart disease,~     high blood pressure, heart failure and stroke. Abnormal arterial function (dilation and~     constriction of the blood vessels) has been observed in these patients and likely contributes~     to the increased risk of cardiovascular problems. However, therapies targeted at improving~     arterial function have not been investigated in this population. Statin therapy (cholesterol~     medicines like Lipitor) have been studied in other subgroups of patients with abnormal~     arterial function and has shown benefit in improving arterial function and reducing risk of~     cardiovascular problems.~      The investigators hypothesize that patients with CoA have abnormal arterial function leading~     to increased cardiovascular risk. We further hypothesize that statin therapy may improve this~     problem. We plan to compile a complete database of information regarding these patients~     cardiovascular health and propose to then examine the effect of atorvastatin (Lipitor) on~     arterial function as measured by changes in arm arterial function tests.~   "
213338|NCT00767559|"~     The purpose of this research is to find a better way to prevent the post operative~     development of clots in the deep veins of the legs (also called Deep Vein Thrombosis or DVT).~     DVT causes redness, swelling, and pain in the involved leg(s). Long-term complications may~     include permanent swelling and pain of the leg(s), and even skin ulcers around the ankle. If~     clots form in a leg after surgery, and break off, they can move to the lungs and block the~     pulmonary artery (also called Pulmonary Emboli or PE). With PE there can be chest pain, chest~     tightness, shortness of breath, coughing up blood, heart failure, and occasionally death.~      Doctors have studied ways to reduce these complications. These studies led to the development~     of drugs which interfere with your body's clotting processes. However, it is still unclear~     which drug and which drug schedule is best. This study will evaluate two of the standard FDA~     approved drugs using different dosing schedules.~   "
213339|NCT00767546|"~     There's high incidence of seborrhic dermatitis among patients suffering from Parkinson's~     disease. Seborrhic dermatitis is caused by increased exertion of sebaceous glands. Previous~     studies have shown an increase of sebum excretion rate in parkinsonian pateints. Other~     studies demonstrated improvement in seborrhic dermatitis after anticholinergic treatment.~     From these studies we concluded that there might be hyperactivity of the parasympathetic~     system among PD patients, that cause increased exertion of sebum, therefore local injection~     of botulinium toxin, which inhibitis acetyl choline realese, might improve the rash of~     seborrhic dermatitis.~      40 patients suffering from Parkinson disease or other parkinsonian disorders will participate~     in this study.~      Before treating the patients with botulinium toxin, we will measure the sebum exertion with~     the sebumeter device and make clinical evaluation of the rash. We will also take a picture of~     the rash.~      Then Botulinium toxin (60- 100 units) will be locally injected to the rash area.~      Two weeks after the injection the patients will be called and evaluated clinicly and by the~     sebumeter. Then they will be checked again after 3 weeks, after a month and after two, three~     and four month's.~   "
213340|NCT00767533|"~     To learn whether or not an Interferon defect in cell signaling, recently discovered in immune~     cells from melanoma patients as well as breast cancer patients, is common to all cancers.~   "
213341|NCT00767520|"~     The purpose of this study is to determine whether exemestane plus dasatinib will be~     well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced~     estrogen-receptor positive (ER+) breast cancer after disease progression (PD) on a~     non-steroidal aromatase inhibitor (NSAI).~   "
213342|NCT00767507|"~     The purpose of this study is to demonstrate that patients receiving cangrelor infusion before~     coronary artery bypass grafting have an acceptable safety profile and can undergo surgery~     without excessive bleeding peri-operatively.~   "
213343|NCT00767494|"~     The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide~     dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs.~     AZOPT dosed BID in patients with open-angle glaucoma or ocular hypertension.~   "
213344|NCT00767481|"~     Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP~     lowering efficacy and safety over 12 months of morning or evening instillations of~     Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with~     open-angle glaucoma or ocular hypertension.~   "
213345|NCT00767468|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib in~     treating patients with locally advanced or metastatic liver cancer and cirrhosis.~   "
213346|NCT00767455|"~     Cumulative Irritation Patch Test~   "
213351|NCT00767390|"~     The Purpose of this clinical investigation is to observe the changes in relative conductivity~     between the six ACL patches over time. In addition, the clinical investigation will evaluate~     the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back.~     During the study the adhesiveness properties of the patches will be evaluated.~   "
213352|NCT00767377|"~     The purpose of this study is to evaluate the efficacy and tolerability of the combination of~     epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in~     patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two~     addition second endpoints was added to the trial, one was to compare the consistence of two~     types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for~     predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This~     modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the~     approval number was IRB50-15-1101A.~   "
213353|NCT00767364|"~     Rotavirus infection is a common pediatric illness and is the leading cause of severe acute~     gastroenteritis (vomiting and diarrhea) in infants and young children. Since February of~     2006, an oral vaccine to prevent rotavirus has been approved by the Food and Drug~     Administration (FDA). The company that makes the oral vaccine is Merck and Company. Since the~     FDA approval, the American Academy of Pediatrics (AAP) and that Advisory Committee on~     Immunization Practices (ACIP) has recommended the use of this oral vaccine in infants. A~     previous rotavirus oral vaccine, Rotashield, was removed from the market for concerns that it~     was causing an increase in a gastrointestinal (GI) disease called intussusception. However,~     the new rotavirus vaccine was studied by the manufacturer and was not found to cause an~     increase in the cases of intussusception. Intussusception is a disease in which a portion of~     the GI tract folds back on itself leading to GI tract obstruction or back-up.~      The manufacturer of the vaccine noted on package insert information that the vaccine was not~     studied, originally, in infants with a history of GI disorders or in infants who have had~     surgery on their abdomen. Currently, there is no information available in the scientific~     literature about the use of the oral rotavirus vaccine in infants with GI diseases or those~     who have had GI surgeries.~      The objective of the study is the assessment of safety and tolerability of the oral RotaTeq®~     vaccine for all infants participating in the study. All infants will be followed for clinical~     adverse events with active safety surveillance for the first 42 days after each dose and also~     monthly afterward for a total of 12 months from the first vaccination date. The secondary~     objective of the study is to quantify the immunologic response will occur in all of the~     infants in the study. Assessment of percentage of the number of infants who have a good~     immune response (three-fold rise in IgA titer or greater) to the complete rotavirus vaccine~     series (three oral vaccines in total) by a blood test to check the rotavirus immunoglobulin A~     (IgA) level in infants with short bowel syndrome compared to normal infants will occur.~      Infants, meeting eligibility criteria and whose parents have signed informed consent will~     have their study information collected. These infants will be tested for the presence of~     pre-vaccine anti-rotavirus antibody, IgA levels, as mentioned above. After the blood is~     obtained, participants will receive their first oral rotavirus vaccine dose between the ages~     of 6 weeks to 12 weeks of life per package insert information. This oral rotavirus vaccine~     may be administered with other routine pediatric vaccines at the participant primary care~     provider's office. The date of the rotavirus vaccine and lot number would be recorded on~     vaccine administration date cards. Most participants will have their vaccines given through~     the Infectious Disease clinic staff at the Children's Hospital of Michigan.~      Subsequent doses of the oral rotavirus vaccine will be given at a minimal interval between~     vaccines of four weeks. The third, and final vaccine dose must be given by 32 weeks of life.~     Any adverse reactions to the vaccine will be reported on the National Vaccine Adverse Event~     Reporting System and MedWatch forms.~      Finally, two weeks after the participants have had all three oral rotavirus vaccine doses,~     the second and final blood draw will take place for measuring the post-vaccine level of~     anti-rotavirus antibody, IgA.~      Participants in the study will be monitored by telephone contacts on days 7, 14, and 42 after~     each dose and within 48 to 72 hours of each dose of the rotavirus vaccine regarding any~     serious adverse events. Each infant will also be assessed in the clinical setting each week~     after a vaccine dose has been given. As above, parents of participants will be asked to fill~     out the vaccine report card and record the child's temperature, and any episodes of vomiting,~     diarrhea, blood in the stools or fussiness for the first seven days. The parents will also be~     asked to record any other events from day 8 through 42 after each vaccine is administered~     such as fever, ear infection, runny nose, etc. Afterward, parents will also have monthly~     phone call safety follow-ups during the 12 month period following the first vaccination. A~     Data Safety and Monitoring Board will oversee the study and it's progress and will have the~     ability to vote to stop the study.~   "
213354|NCT00767351|"~     Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and~     mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively~     via the kidneys reduced renal function is a relative contraindication. We have earlier~     demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below~     that level the risk of lactacidosis, a severe complication, increases.~      In the present study we plan to analyse serum levels of metformin repeatedly in patients with~     moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as~     trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be~     taken two hours after intake of the morning dose of metformin. Renal function will be~     estimated with creatinine and cystatin C at each occasion. The intraindividual variation of~     metformin will be calculated.~      The study rests on a new method for measuring metformin. The technique uses Liquid~     Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding~     acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is~     injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.~      The study will show if variation in serum levels of metformin measured in the same patient is~     high or low and thus give us better understanding whether a change i serum level is due to~     biological variation or to increased retention caused by progressive renal failure.~   "
213355|NCT00767338|"~     The primary research hypothesis is that microsurgical varicocelectomy will result in an~     increase in live birth in infertile couples where the male partner has a palpable varicocele~     and an abnormal semen analysis in comparison to male partners who do not have microsurgical~     varicocelectomy.~      The secondary hypotheses include:~        1. To assess whether up to 4 cycles of intrauterine insemination confers any additional~          increase in live birth rates compared to timed intercourse;~        2. To examine spousal pregnancy rate as the secondary outcome; and~        3. To study the effect of varicocelectomy in men with infertility, an abnormal semen~          analysis, and a palpable varicocele on~             -  Testicular semen analysis parameters;~             -  Serological measures of FSH, LH, total and free testosterone and~             -  Measures of quality of life and sexual function in both partners.~   "
213356|NCT00767325|"~     The purpose of the study is to assess early signs of response to abatacept+methotrexate in~     metacarpophalangeal joints in both hands using power Doppler ultrasonography in patients with~     active rheumatoid arthritis.~   "
213357|NCT00767312|"~     This study will determine if the level of virus in HIV-infected patients taking~     antiretroviral medications for prolonged periods decreases or persists at a stable level. It~     will also examine whether new gene changes (mutations) occur during drug suppression.~      HIV-infected patients who are 18 years of age or older, have been enrolled in another NIH~     protocol, have been suppressed on antiretroviral therapy and have very low levels of virus in~     their blood may be eligible for this 5-year (or more) study.~      Participants come to the NIH Clinical Center about every 6 months for a physical examination,~     routine and research blood tests and leukapheresis to collect white blood cells for T cell~     analysis. For leukapheresis, blood is collected through a vein much like donating whole~     blood, but the blood is directed through a machine that separates and extracts the white~     cells and returns the rest of the blood components to the patient. Patients may also have an~     optional third clinic visit each year for another blood draw.~   "
213358|NCT00767299|"~     The study is for Korean women who are postmenopausal and also suffer from osteoporosis.~      The study will test if women who are given 20 mg of arzoxifene once a day for six months have~     a less severe level of osteoporosis than those women who do not take arzoxifene.~      All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily~     starting 4 weeks prior to study drug administration continuing through the 6 months of~     therapy.~   "
213359|NCT00767286|"~     RATIONALE: Patient abstract not available~      PURPOSE: Patient abstract not available~   "
213360|NCT00767273|"~     To test the ability of new imaging techniques to monitor and predict response of pancreatic~     cancer to radiation and/or chemotherapy.~   "
213361|NCT00767260|"~     There were evidences that the non-immune mediated inflammatory pathways of cell damage~     occurred in vitro in human islets upon hyperglycemia in type 2 diabetes mellitus. Autologous~     stem cell therapies were an emerging set of therapies that showed promise with a low side~     effect profile. we hypothesized that infusion of mononuclear cells from buffy coat obtained~     from bone marrow might provide multiple signals for regeneration and inflammation-induced~     lesion recovery of local tissues, of which the effect might be maximized by intra-arterial~     pancreatic infusion through angiography and combination with hyperbaric oxygen therapy.~      This trail includes a foregoing sub-trial that investigate the feasibility and safety of a~     novel method for massive bone marrow collection. The traditional BM collecting procedure is~     unfavorable because it yields minor bone marrow. Studies have shown that physiological~     exercise can increase bone marrow blood flow, which might facilitate BM collection.~      We plan to include a total of 60 patients with type 2 diabetes and randomly assign them to~     either a control group or an exercise group (n =30 each). The patients in the exercise group~     exercised 30 minutes before the operation. All patients underwent routine surgical care. The~     collected BM volume, operation time, collecting speed , puncture times and pain scores during~     the operation were recorded. Bone marrow samples were tested for CD34+ flow cytometry and~     whole blood cell count.~   "
213362|NCT00767247|"~     Analysis of antihypertensive treatment efficacy.~   "
213363|NCT00767234|"~     To determine whether biomarkers assessed in blood samples can be used to detect individuals~     at risk for developing blood clots or worsening of their underlying disease. The ultimate~     goal of the study is to identify key biomarkers derived from blood that are most~     characteristic and informative of individuals who will go on to develop a clotting~     complication.~   "
213364|NCT00767221|"~     The study will investigate the effect of PL-56 on albumin leakage and renal function~     (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety~     of treatment with PL-56.~   "
213365|NCT00767208|"~     The aim of this trial was to compare postprandial metabolic response to glucose load in~     healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid~     profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess~     postprandial total,exogenous and endogenous glucose kinetics.~   "
213366|NCT00767195|"~     Pulmonary edema can be classified into cardiogenic pulmonary edema and non-cardiogenic~     pulmonary edema according to the underlying etiology. Cardiogenic pulmonary edema is caused~     by the dysfunction in the cardiac pumping capability, leading to the transudation~     accumulation in the pulmonary peri-capillary space. The predisposing factors of~     non-cardiogenic pulmonary edema are numerous, including severe infection, renal failure,~     auto-immun reaction, etc. The mortality rate of pulmonary edema is relatively high,~     especially the non-cardiogenic one. To distinguish the type of pulmonary edema at the early~     stage is important for its treatment.~      Lung sound analysis via stethoscope is a simple diagnostic method to lung diseases~     clinically. Among many kinds of lung sounds, the crackle and rale are frequently found in~     pulmonary edema. Rale is also called moist rale. It is considered as low-frequency~     wheezes and is often seen in cardiogenic pulmonary edema. On the other hand, crackle is~     also called dry rale, which is a kind of high-frequency wheezes and usually seen in Acute~     Respiratory Distress Syndrome (ARDS) that is classified into non-cardiogenic pulmonary edema.~      This proposed project intends to establish a digital diagnostic method for pulmonary edema.~     The lung sound of patient with pulmonary edema will be collected by the lung sound~     acquisition system. By identifying the significant spectrum characteristics of cardiogenic~     pulmonary edema and non-cardiogenic pulmonary edema, the diagnostic system might be~     established.~   "
213367|NCT00767182|"~     Pregnancy complications called PVP are mainly responsible for perinatal mortality. In these~     cases, the placenta is smaller and often the centre of thrombotic lesions. The estimation of~     the placenta volume by 3D ultrasound coupled with growth factors and D-Dimers measures could~     improve the understanding of these pathologies to optimize their detection.~   "
213368|NCT00767169|"~     Dental implants (screws for fastening false teeth) have been coated with bisphosphonates~     (drugs that slow down removal of bone). Patients get one such screw and one without coating,~     by a surgeon who does not know which is which. The screws are compared by measuring how well~     fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the~     bisphosphonates will improve fixation.~   "
213369|NCT00767156|"~     The effect of oral supplementation of SBA24 sea buckthorn oil capsule and topical application~     of Omega7 sea buckthorn cream on skin ageing is studied in a single blind, parallel study.~   "
213370|NCT00767130|"~     Lipitor®, Zocor®, and Crestor® are statin drugs commonly taken to lower cholesterol and~     prevent heart disease. Statins lower cholesterol by different amounts in different patients~     and sometimes statins cause muscle pain, cramps, or weakness. This study will examine genetic~     differences in the blood of patients taking statins to predict both how well the statins~     lower cholesterol, and whether muscle discomfort occurs. Finding such genetic connections is~     the key to developing genetic tests that might eventually help determine which statin is best~     for a patient. About 1000 people will be in the study.~   "
213371|NCT00767117|"~     The purpose of the study is to determine the effect of steady-state concentrations of LPV,~     co-administered with a low dose of ritonavir, on the steady-state pharmacokinetics of TMC125~     and to determine the effect of steady-state concentrations of TMC125 on the steady-state~     pharmacokinetics of LPV, co-administered with a low dose of ritonavir.~   "
213372|NCT00767104|"~     The purpose of this research study is to better understand how this study pillowcase works~     when people use it to treat acne. Most people, including people with acne, sleep six to eight~     hours each night in direct contact with bedding fabrics that provide no benefit to the~     healing process associated with acne. The fabric in this study pillowcase may be able to~     reduce bacteria on the skin. This study would evaluate how acne is affected by this silk-like~     pillowcase. This type of study has not been done before.~   "
213373|NCT00767091|"~     Apathy usually refers to a set of behavioural, emotional and cognitive features as a reduced~     interest and participation in main activities of daily life, a lack of initiative, a trend~     toward an early withdrawal from started activities, an indifference and a flattening of~     affect. We have validated a new specific scale (Lille Apathy Rating Scale, LARS) in order to~     detect and quantify apathy in Parkinson's disease (PD). Apathy was shown to be frequent in PD~     with a prevalence of 32%. It has suggested that the medial frontal and limbic cholinergic~     deficits may underlie apathy in neurodegenerative disorders like Alzheimer's disease (AD).~     Such a hypothesis is supported by recent evidence indicating the beneficial effects of~     cholinesterase inhibitors on neuropsychiatric symptoms, mainly apathy, in AD patients. As the~     efficacy of rivastigmine on cognition has also been shown in PD, we aimed to assess with a~     randomized, double-blind, placebo-controlled, parallel-group, multicenter trial, the efficacy~     and acceptability of a 6 months treatment with rivastigmine on apathy in 60 patients with PD~     without dementia. The primary end point will be the LARS score and the secondary end points~     will be the cognitive, behavioural and motor symptoms of PD. Two add-on studies will be~     proposed: first the measure of choline and glutamate peaks on Magnetic Resonance Spectrometry~     focused on the structures implicated in apathy in order to give insights in the~     physiopathological mechanisms of the treatment. Secondly, the recording of the REM sleep~     behavior disorders in relation with the cholinergic part of the pedunculopontine nucleus.~     Regarding that apathy could be one of the first steps toward PD dementia, treating very early~     could have substantial implications on the patients and their caregiver.~   "
213520|NCT00765115|"~     To test that LY450139, a gamma-secretase inhibitor, will reduce the rate of newly synthesize~     Amyloid Beta by determining the amount of newly synthesized 13C6 leucine-labeled Amyloid Beta~     in lumbar cerebrospinal fluid from LY450139 treated subjects compared with placebo treated~     subjects.~   "
213374|NCT00767065|"~     This is a randomised trial comparing early Cardiac Computed Tomography (CCT) to current~     standard practice for diagnosis of acute chest pain in patients at low to intermediate risk~     of having coronary artery disease (CAD), in a UK setting. We hypothesise that early CCT can~     reduce length of admission, reduce NHS costs and improve quality of life whilst being at~     least as safe as standard practice.~   "
213375|NCT00767052|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to~     evaluate the single-dose relative bioavailability of the oral suspension and oral tablet~     formulations.~   "
213376|NCT00767039|"~     Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome~     (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the~     FDA were more concentrated and had a more rapid onset of action. The overall efficacy of~     newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a~     double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to~     infants treated with Survanta, the most commonly used surfactant preparation in the United~     States. While the data was suggestive, it was not clear that the improvement in survival was~     reproducible or that Curosurf was responsible for the improved survival rates.~      The purpose of this study was to investigate the role of Curosurf in improving lung function~     and survival rates and reducing the complications of prematurity in very premature infants <~     30 weeks gestational age at birth.~   "
213377|NCT00767026|"~     The purpose of this study is to determine if the program Creating Opportunities for Parent~     Empowerment (COPE) is feasible to administer to parents of children with neurological~     conditions. The goal of the study is to empower parents by providing them with educational~     materials designed to teach them how to foster healthy coping skills in their child.~   "
213378|NCT00767013|"~     We sought to determine whether the dual-source computed tomography assessment of aortic valve~     stenosis and coronary artery disease is equivalent to or even better than conventional~     invasive coronary angiography and transthoracic echocardiography.~   "
213379|NCT00767000|"~     The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants~     taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that~     treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c~     (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be~     well-tolerated at 1 or more doses that demonstrate efficacy.~   "
213380|NCT00766987|"~     Positron Emission Tomography (PET) is a non-invasive, unique nuclear imaging technique that~     allows the evaluation of blood flow in the heart and provides information about the cell~     activity of specific organs such as the heart and brain. It also provides useful information~     for the management of patients with poor pumping function of the heart, heart failure, and~     coronary artery disease. A cardiac viability imaging looks at how the heart uses glucose~     (sugar) The imaging process determines areas of the heart that are alive (viable - using~     sugar) versus areas of the heart that are scar tissue (non-viable). F-18 fluorodeoxyglucose~     (FDG) is the radioactive substance used to determine myocardial viability. This nuclear~     imaging technique has been shown to be useful in directing management for patient care.~      The Ministry of Health recognizes the clinical utility of FDG PET imaging for myocardial~     viability assessment and other cancer indications. Optimizing the potential advantages of FDG~     PET in Ontario, will require characterization of the patient population, referral patterns,~     upstream and downstream resource utilization and patient outcomes. Therefore, registry~     studies are being undertaken to provide specific information about the utility of PET in~     these clinical situations in Ontario. The proposed registry will facilitate monitoring of the~     implementation of this limited technology and allow continued evaluation of practice patterns~     and outcomes. The University of Ottawa Heart Institute is the coordinating centre for this~     project with PET centres in London, Hamilton and Toronto also participating.~      The purpose of this study is to evaluate the utility of FDG PET viability imaging in the~     decision making process for patients with poor left ventricular function who may be~     candidates for revascularization and to study the downstream effect of the clinical~     management decisions. Patients meeting specific inclusion criteria will be eligible for this~     study.~   "
213381|NCT00766974|"~     Objectives: To quantify the clinical improvement and quality of life between patients wearing~     compression stockings versus anti-embolism stockings in patients with varicose veins and limb~     edema.~   "
213382|NCT00766961|"~     The aim of the study is to compare the outcomes of trans-catheter arterial embolization (TAE)~     and surgery as salvage therapy of peptic ulcer bleeding after failed endoscopic therapy.~   "
213383|NCT00766948|"~     By creating a neurogenebank from Parkinson's disease patients' blood donations we will~     ultimately be able to define genes for Parkinson's disease and other neurological conditions.~   "
213384|NCT00766935|"~     The purpose of this project is to prove that the Imp™SFB7+ (L-Dex U400) is equivalent to the~     Imp™ XCA device in assessing Lymphoedema. The Imp™ XCA device is a simple device capable of~     assessing Lymphoedema of a single arm. The Imp™SFB7+ (L-Dex U400) is a more complex device~     capable of assessing Lymphoedema in a larger population of Lymphoedema sufferers. The~     Imp™SFB7+ (L-Dex U400) will be developed to assess patients with Lymphoedema in their arms or~     their legs. The Imp™ XCA and Imp™ SFB7 are both TGA approved devices. The Imp™ SFB7+ (L-Dex~     U400) is similar to the Imp™ SFB7 the changes are to the software and user interface.~   "
213385|NCT00766909|"~     Cyclosporine (CsA) and Tacrolimus (Tac) are immunosuppressive agents comprising the~     cornerstone of treatment among organ transplant recipients. Unfortunately diabetes is a known~     complication after transplantation, yet the underlying mechanisms of this type of diabetes~     are still unresolved. A direct comparison of the diabetogenic effects of CsA and Tac, without~     interference of corticosteroid treatment, has not yet been investigated using a~     hyperinsulinemic euglycemic glucose clamp technique, which is the best method for estimating~     insulin sensitivity.~      Randomized, investigator-blinded cross-over studies will be carried out, studying 10 healthy~     subjects and 10 hemodialysis patients. Each participant will receive treatment with CsA, Tac~     and placebo respectively in a random order. The results will be of relevance to the choice~     and monitoring of immunosuppressive regimens in kidney transplant recipients as well as the~     development of better treatment modalities for diabetes.~   "
213414|NCT00766506|"~     The purpose of this study is to evaluate the mobilization characteristics, clinical use,~     safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled~     Analgesia (PCA) system (Ionsys) and morphine intravenous (IV) PCA for management of moderate~     (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in~     participants who have undergone elective major abdominal or orthopedic (pertaining to the~     bones) surgery.~   "
213415|NCT00766493|"~     Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with~     FDA-approved carotid stents to a performance goal obtained from carotid stent studies~     utilizing distal embolic protection.~   "
213386|NCT00766896|"~     STUDY QUESTIONS~        -  What is the real prevalence of platelet resistance to aspirin during the acute phase~          of stroke and after 3 months, and 1 year, as measured using different platelet function~          tests?~        -  Do all methods measure similar levels of resistance, or are some methods more sensitive~          than others?~        -  Does this resistance result in a worse clinical prognosis? Is this result independent of~          other variables?~      OBJECTIVES~        1. Hospital Phase (Acute Stroke)~             -  Determination, using various methods, of the prevalence of platelet hyperreactivity~               in patients treated with aspirin to treat ischemic stroke (acute phase)~             -  Comparison of different assessment methods and identification of the most accurate~               of these~             -  Identification of variables that correlate with platelet hyperreactivity~        2. Follow-up Phase~             -  Correlation between platelet hyperreactivity and important clinical outcomes at 12,~               24, and 36 months~             -  Correlation between platelet hyperreactivity and death or dependency at hospital~               discharge, at 3, 12, 24, and 36 months (Modified Rankin Scale)~             -  Correlation between platelet hyperreactivity and recurrent stroke of any type~             -  Correlation between different methods for evaluating platelet functions and~               identification of the most accurate method~             -  Analysis of hyperreactivity over time~      THE STUDY~        -  The study will include 200 consecutive patients seen in the emergency department of a~          large, urban hospital (1500 inpatient beds) and diagnosed with stroke in the acute~          phase; these patients will be treated with aspirin for an undetermined period~        -  The investigators will not include patients who require full anticoagulation treatment,~          regardless of the cause~        -  Importantly, the analysis of primary and secondary outcomes will be carried out after~          blinding the examiner to the results of the platelet aggregation tests~      PLATELET TESTS~        -  Whole Blood Aggregometer, ChronoLog~        -  VerifyNow, Accumetrics~        -  PFA-100, Siemens~        -  Plateletworks, Helena~        -  Impact-R, Diamed~        -  Serum thromboxane B2~   "
213387|NCT00766883|"~     This study will examine the effectiveness of problem-solving education for patients who are~     undergoing a stem cell transplant and their caregivers. The emotional stress of transplant~     extends beyond patients to their caregivers; this study will identify the type of education~     that will be most helpful to transplant caregivers.~      Adult patients undergoing stem cell transplant at the NIH s Clinical Center and their adult~     caregivers are eligible for this study. The caregiver must be caring for the patient from~     before hospital admission for the procedure until 6 weeks following the transplant. Both~     patient and caregiver must be able to read and speak English.~      Patients and caregivers have three education sessions (in addition to the routine transplant~     education provided at the Clinical Center) and complete three study questionnaires as~     follows:~        -  Questionnaires: The questionnaires vary somewhat for patient and caregiver, but include~          information on demographics (e.g., sex, race, marital status, education level),~          distress, lifestyle, relationship with the caregiver/patient, confidence level,~          symptoms, pain, fatigue and sleep quality. Questionnaires are completed before the~          patient undergoes the transplant (and before attending any education sessions), before~          the patient is discharged from the hospital and 6 weeks after hospital discharge.~        -  Education sessions: The 60-minute sessions are designed to teach problem-solving~          strategies by looking at problems in a new way and learning effective communication~          skills. The sessions are conducted before the patient is discharged from the hospital, 1~          week after discharge and 3 weeks after discharge.~   "
213388|NCT00766870|"~     The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed~     dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive~     Disorder.~   "
213389|NCT00766857|"~     The purpose of this study is to determine if exenatide will improve global cardiac function~     in patients with type 2 diabetes mellitus and congestive heart failure, by favorable effects~     on cardiac metabolism leading to improvement of cardiac efficiency.~   "
213390|NCT00766844|"~     The study investigates safety, feasibility and effectiveness of cervical spinal cord~     stimulation (SCS) in prevention of cerebral arterial vasospasm following aneurysmal~     subarachnoid hemorrhage (aSAH).~      It is postulated that 2 week long stimulation of the cervical spinal cord using an implanted~     epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following~     aSAH.~   "
213391|NCT00766831|"~     The purpose of this is study to evaluate improvement of sleep disorder caused by cancer pain~     after the administration of Hydromorphone Oral Osmotic System (OROS) in Korean participants~     with cancer.~   "
213392|NCT00766818|"~     In this study, we are looking at blood concentrations of Kaletra in HIV positive patients~     during pregnancy. The patients will come in for 4 visits lasting ~24hrs. These visits take~     place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week~     30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet~     (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum,~     then it will return to the standard 2 adult tablets (400/100mg).~   "
213393|NCT00766805|"~     Background: Both endoscopic variceal ligation (EVL) and propranolol are valuable methods for~     secondary prophylaxis of variceal bleeding. Addition of ISMN to propranolol improves the~     efficacy of drug therapy. It is hypothesized that a combination of EVL and portal pressure~     reducing drugs should significantly be better than EVL alone.~      Patients and Methods: Patients with history of variceal bleed were randomized to EVL plus~     drugs (propranolol and ISMN) or EVL alone. EVL was repeated every 3-4 weeks until variceal~     eradication. Propranolol dose was adjusted to reduce the resting heart rate to 55 bpm. Dose~     of ISMN was 40 mg/d. Primary end points were rebleed or death. Secondary end points included~     complications of portal hypertension and the development of serious adverse effects to~     therapy.~   "
213394|NCT00766792|"~     Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to~     nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with~     patients staying on standard dialysis will be followed. The study will last 30 weeks. During~     this period blood samples (pre- and post-dialysis: 10 times; inlet and outlet of dialyzer: 3~     times) will be collected on predetermined time points. Concentration of several uremic~     retention solutes will be determined.~   "
213395|NCT00766779|"~     A study comparing conventional chemotherapy to low dose total body irradiation-based~     conditioning and hematopoietic cell transplantation from related and unrelated donors as~     consolidation therapy for older Patients with AML in first Complete Remission.~   "
213416|NCT00766480|"~     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This clinical trial is studying tissue samples in predicting how well chemotherapy~     and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the~     esophagus.~   "
213417|NCT00766467|"~     The purpose of this research study is to determine if armodafinil is safe and effective in~     treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy~     plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the~     treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also~     help to reduce radiation-induced fatigue in brain tumor patients.~   "
213396|NCT00766766|"~     SMOKN5 is aimed at studying ways to reduce environmental tobacco smoke (ETS) for children who~     are being treated for cancer. The study includes St. Jude parents whose child lives with at~     least one adult smoker who exposes the child to ETS, also called secondhand smoke. We are~     comparing two groups of parents to see which group results in lower ETS exposure levels for~     the child being treated with cancer. The first group will receive the standard information~     and advice usually given to parents about secondhand smoke. The second group will take part~     in a new program designed to reduce ETS. The primary objective of the study is to determine~     the efficacy of an environmental tobacco smoke intervention compared to the standard care~     control condition, as measured by parent report. Parents in each group answer questions about~     ETS exposure. We also collect urine samples from the child at specific time points throughout~     the study. The urine is tested to measure the amount of cotinine, a metabolite of nicotine.~     Measuring cotinine tells us how much nicotine from tobacco smoke the child has been exposed~     to. Children who are at least 10 years of age or older will also be asked to complete a set~     of questions pertaining to their tobacco use history and ETS exposure from others. This will~     occur at the same five time points in which the parent completes his/her portion. The study~     will last about 12 months for each participating family. Parents who take part in the study~     may learn how to lower their child's exposure to ETS, and this may, in turn, lower the~     child's chances of having ETS-related health problems.~   "
213397|NCT00766753|"~     This is a single-institution Phase I/II study designed to evaluate the safety and induction~     of an immune response, and preliminary clinical response of vaccinations with Type-1~     alpha-DCs (alpha-DC1) loaded with glioma-associated antigen (GAA) epitopes and administration~     of poly-ICLC in patients with recurrent malignant gliomas. Approximately 30 subjects will be~     enrolled in this study at UPMC/UPCI Hillman Cancer Center. The study participants in this~     trial will be HLA-A2 positive male or female adults over 18 years of age. The primary~     objective is to establish the safety of this approach. The endpoints will be to determine the~     maximum tolerated dose (MTD) of alpha-DC1 vaccines in combination with a fixed dose of~     poly-ICLC, using standard criteria and close clinical followups. The secondary objectives are~     1) to assess the immunological response against GAAs in patients with recurrent malignant~     gliomas immunized with DCs loaded with GAA-derived peptides using enzyme-linked immuno-spot~     (ELISPOT), delayed-type hypersensitivity (DTH) and tetramer assays; and 2) to assess the~     preliminary anti-tumor clinical activity of the vaccines as measured by radiological response~     (MRI), overall survival, and 4- and 6-month progression-free survival (PFS).~   "
213398|NCT00766740|"~     Available data from randomized trials on thrombectomy in patients with ST-elevation~     myocardial infarction have shown favourable trends on myocardial reperfusion. Better~     myocardial reperfusion may translate in better late clinical outcome. However, only few data~     are available on the impact of thrombectomy on long term clinical outcome.~      Thus, the investigators designed a collaborative individual patient-data pooled-analysis~     aimed to assess the long-term clinical outcome in STEMI patients randomized to percutaneous~     coronary intervention with or without thrombectomy.~   "
213399|NCT00766714|"~     A prospective randomized trial comparing Cook K-SOFT-5100 and Frydman classical catheter 4.5~     for embryo transfer in human IVF/ICSI was performed. Three experienced operators participated~     in the trial, using a fixed distance transfer protocol. Primary endpoint was clinical~     pregnancy rate, secondary endpoints were rates of difficult transfer and of catheter failure.~     Patients were randomized by a computer program immediately prior to embryo transfer.~   "
213400|NCT00766701|"~     The overall objective of this study is to evaluate whether fluorescence and reflectance~     spectroscopy can improve the ability to detect the presence of premalignant lesions on the~     cervix.~      The specific aims of the study are:~        -  To compare information obtained from fluorescence and reflectance spectroscopic~          measurements of the cervix with standard methods for detecting cervical pre-cancers.~        -  To validate previously developed algorithms for discriminating between normal and~          pre-cancerous tissue based on spectroscopic measurements.~        -  To evaluate the safety of spectroscopic measurement of cervical tissue.~   "
213401|NCT00766688|"~     The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on~     to ongoing treatment with high doses of statin in a double-blind manner in comparison with~     placebo, in the management of patients with severe primary hypercholesterolemia considered as~     inadequately controlled despite their ongoing statin treatment.~      The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C~     level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters~     will be assessed as secondary objectives.~   "
213402|NCT00766675|"~     The purpose of this study is to evaluate the analgesic effect of combination of tramadol~     hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic~     widespread pain and presence of tender points).~   "
213403|NCT00766662|"~     Studies have shown that Intermittent preventive treatment in infants (IPTi) with~     Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without~     modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential~     public health tool of great benefit to the children of Africa and a logical addition to the~     Immunization Plus package. The objectives of this operational researcher were~        -  to develop an implementation model for IPTi in the health care system in Mali~        -  to assess its impact on the EPI vaccines and other health interventions coverage~        -  and on molecular makers of resistance to SP~   "
213418|NCT00766454|"~     RATIONALE: Studying samples of urine and blood from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This study is looking at urine and blood samples in women with newly diagnosed~     breast cancer.~   "
213419|NCT00766441|"~     This study will assess if Sitagliptin addition to metformin or glitazone is better than~     current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin~     offers metabolic advantages primarily with the low incidence of hypoglycemia over current~     sulphonylurea based treatments.~   "
213420|NCT00766415|"~     The purpose of this study is to study histological changes, cellularity, clinical efficacy~     and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease~   "
213875|NCT00760396|"~     The purpose of this study is to evaluate the safety profile, tolerability and~     pharmacokinetics following multiple oral doses of 40mg to 200mg VGX 1027 in healthy subjects~     administered for 5 days.~   "
213404|NCT00766649|"~     This study will determine if a drug called sirolimus is safe to give to people with~     geographic atrophy GA and if it can help preserve vision in patients. GA is an advanced form~     of dry age-related macular degeneration (AMD). AMD affects the macula, the central part of~     the retina needed for sharp, clear vision. There are two types of AMD, wet and dry. In dry~     AMD, cells in the macula die.GA may at least partly be caused by inflammation. Sirolimus~     helps prevent inflammation and therefore may help treat GA.~      People with GA in both eyes with visual acuity between 20/20 and 20/400 in each eye may be~     eligible for this study. Participants undergo the following tests and procedures:~        -  Sirolimus injections in the study eye at each 3-month clinic visit. The drug is injected~          under the outer layer of the eye after the patient receives antiseptic and numbing~          drops. Antibiotic drops are continued for 2 days after the injection.~        -  Eye examinations before the first injection, 1 month after the first injection, during~          each clinic visit (11 to 15 visits over 2 to 3 years) and 3 months after the final~          injection. The examination includes testing visual acuity, measuring eye pressure and~          checking eye movements. To examine the inside of the eye, the pupil is dilated with eye~          drops. Regular photographs of the inside of the eye and optical coherence tomography~          photographs, which allow measurement of the thickness of the retina, may be taken during~          the eye examination.~        -  Autofluorescence imaging. The patient sits in a chair with his or her head placed in a~          chin rest in front of a camera. A light in the camera is used to scan the eye.~        -  Blood tests. Blood is drawn at the first visit and at up to seven study visits to check~          blood chemistries, such as liver and kidney function.~        -  Urine pregnancy test for women who are able to become pregnant.~   "
213405|NCT00766636|"~     Primary Objective:~      To assess margin positive resection rate (R1 resection rate; defined as tumor within 2 mm of~     surgical margin on final pathology report) in patients treated with preoperative~     chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy~     followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head.~      Secondary Objectives:~        -  To assess disease free survival~        -  To assess overall survival~        -  To assess patterns of local and distant failure~   "
213406|NCT00766623|"~     The primary aim of this study is to evaluate the effect of a high fat challenge on several~     measures of endothelial function. The secondary aim of this study is to elucidate the~     mechanism of postprandial endothelial dysfunction and to identify early biomarkers~   "
213407|NCT00766597|"~     Complications with current HIV antiretroviral therapy have left many children and adolescents~     with limited therapeutic options due to drug resistance. The purpose of this study is to test~     the effectiveness and safety of Vicriviroc (VCV), an HIV entry inhibitor and CCR5 co-receptor~     antagonist.~   "
213408|NCT00766584|"~     The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which~     permanently feed information back to this global biological vigilance system controlling~     allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one~     of the best indicators of ANS activity.~      Low ANS activity level is associated with severe cardiac and cerebral events, as well as to~     death from any cause in the general population. It is even associated with sleep~     apnea/hypopnea.~   "
213409|NCT00766571|"~     This study will explore the medical problems in patients with VACTERL association and~     identify gene changes that might be responsible for them. VACTERL association can affect many~     parts of the body, including the bones of the spine, the heart, the lower intestinal tract,~     the connection between the trachea and esophagus, the kidneys and the arms. Information from~     this study may lead to a better understanding of the disease and improved treatment and~     genetic counseling.~      Patients with VACTERL association and their parents and siblings may be eligible for this~     study.~      Patients are admitted to the NIH Clinical Center for evaluation over 3 to 4 days that may~     include the following procedures:~        -  Physical examination, medical history, electrocardiogram (EKG), blood and urine tests~        -  Eye examination~        -  Imaging studies (echocardiogram, x-rays and ultrasound tests)~        -  Other specialized tests or consultations as indicated~        -  Optional medical photographs of the face and other body parts that may be involved in~          VACTERL association for publication in scientific texts or for teaching purposes~        -  Optional return visit after 2 years for repeat testing and to look for changes over time~      Parents of patients have the following procedures:~        -  Physical examination, medical history, blood tests and x-rays, if needed~        -  Specialty consultations as indicated~        -  Optional medical photographs of the face and other body parts that may be involved in~          VACTERL association for publication in scientific texts or for teaching purposes~        -  Questionnaires about their child s medical history, growth, behavior and development,~          therapy and medication~      Siblings of patients have the following procedures:~        -  Physical examination, medical history and blood tests~   "
213410|NCT00766558|"~     A technique that has been found to be effective at relieving the physical and psychological~     symptoms associated with inhibiting emotions and emotional thoughts is written emotional~     disclosure. The goal of this study is to evaluate the effectiveness of written emotional~     disclosure on the remediation of eating disorder behaviour, cognitions, and management of~     emotions.~   "
213411|NCT00766545|"~     The multi-center, double-blind, placebo-controlled, randomized, group-comparison study was~     designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in~     preventing the recurrence of cerebral infarction in patients who had suffered a cerebral~     infarction 1 to 6 months prior to entering the trial.~   "
213412|NCT00766532|"~     Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption?~      Study Design: Postmenopausal women with early stage breast cancer initiating aromatase~     inhibitor adjuvant therapy will participate in this two-month study. The primary study~     outcome is the change in intestinal calcium absorption following such therapy. Secondary~     outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms~     after initiation of therapy.~      We will interview women and review their medical records to determine eligibility. Eligible~     subjects will undergo two calcium absorption studies. The first study will determine their~     baseline calcium absorption, and the second study will occur after taking an aromatase~     inhibitor daily for at least 6 weeks. Women will present to the research unit in the early~     morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the~     next 24 hours, we will collect all urine for measurement of its calcium content. During each~     inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint~     examination. Each woman will complete a four-day diet diary twice during the study.~   "
213413|NCT00766519|"~     The purpose of this study is to determine whether intraoperative goal-directed fluid~     management (with goal = cardiac stroke volume maximization) based on respiratory-induced~     pulse pressure variation monitoring may improve outcome after intrabdominal surgery~   "
213433|NCT00766246|"~     This is a randomized, open-label, multicenter study in 160 patients in first line treatment~     and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV).~   "
213421|NCT00766402|"~     The purpose of the study is to investigate the clinical benefit of tramadol/acetaminophen~     versus non-steroidal anti-inflammatory drugs (NSAID) (diclofenac 50 milligram [mg]) in the~     treatment of pain in participants with ankylosing spondylitis (inflammation of the spine~     causing pain and stiffness) receiving stable treatment of disease modifying anti-rheumatic~     drugs (DMARDs).~   "
213422|NCT00766389|"~     The Cirrus HD OCT, a new spectral domain optical coherence tomography (OCT), has better~     resolution than the previous time domain Stratus OCT. Discriminating ability of these two~     OCTs for diagnosis of glaucoma and judgement of disease progression will be studied.~   "
213423|NCT00766376|"~     The purpose of this research study is to evaluate the safety and effectiveness of erbium~     lasers for dermatological cosmetic procedures.~   "
213424|NCT00766363|"~     This study is being conducted to determine the safety, tolerability, and pharmacokinetics~     (PK) of three different doses of an investigational medication, EVP-6124, in individuals with~     mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI~     [acetylcholinesterase inhibitor]: either donepezil or rivastigmine). In addition, PK of AChEI~     medications will be assessed. Cognitive function will be evaluated on an exploratory basis.~   "
213425|NCT00766350|"~     Quetiapine, a second generation antipsychotic, has shown beneficial activity on fibromyalgia~     symptomatology, administered as add-on treatment, in a sample of 35 patients. The purpose of~     the present study is to compare, in a controlled setting, the efficacy and the tolerability~     of quetiapine extended release with amitriptyline in the treatment of patients with~     fibromyalgia~   "
213426|NCT00766337|"~     The purpose of this study is to determine the safety and efficacy of an ocular sirolimus~     (rapamycin) formulation in combination with Lucentis in patients with sub-foveal choroidal~     neovascularization secondary to age-related macular degeneration.~   "
213427|NCT00766324|"~     To assess the antitumor activity of PHA-739358 administered as IV infusion according to two~     different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based~     1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule~     for further investigation.~   "
213428|NCT00766311|"~     Survivors of childhood leukemia have muscle weakness and impaired mobility (physical~     performance), a higher than expected frequency of obesity, and early mortality from~     cardiovascular disease. Treatment related neuropathy, cardiotoxicity and general cachexia may~     complicate physical performance and establish a pattern of sedentary behavior that may lead~     to a lifetime of inactivity. There is limited evidence that children being treated for~     leukemia benefit from home exercise programs during the maintenance phase of therapy,~     particularly in terms of muscle strength and range of motion. However, there are no~     established guidelines regarding the prescription of exercise for children diagnosed with~     leukemia. We propose to test the feasibility of an exercise intervention among children being~     treated for acute lymphoblastic leukemia (ALL) and hypothesize that children who participate~     in the exercise intervention will demonstrate improvements in gross motor function, strength,~     flexibility, and cardio respiratory fitness, and that they will have more favorable body~     composition when compared to the children who are assigned to the usual activity group.~   "
213429|NCT00766298|"~     102 late- life adults at risk for developing type 2 diabetes mellitus, will be randomized to~     one of three interventions designed to improve insulin sensitivity thereby potentially~     preventing future progression of type 2 diabetes. The investigators predict that insulin~     sensitivity will improve equally following either weight loss or exercise, while there will~     be additive effects from combined intervention.~      The investigators hypothesize that weight loss will decrease intermuscular adipose tissue,~     intramyocellular lipid, and visceral abdominal adipose tissue.~   "
213430|NCT00766285|"~     Influenza is a common infection of the upper airways and lungs, and is caused by viruses.~     Cancer patients may need a stronger influenza vaccine than the general population to protect~     against influenza. The experimental vaccine is designed to be 9 times stronger than the~     standard vaccine, which may cause a stronger immune response against influenza in patients~     with a weakened immune system. The goal of this study is to compare the effects of a new~     experimental influenza vaccine to the effects of the standard influenza vaccine. One hundred~     bone marrow recipients, adult volunteers from the MD Anderson Cancer Center, 18 years of age~     or older, will participate in this study. They will be randomly (by chance) assigned to~     receive 2 doses of either the standard licensed influenza vaccine or the experimental~     influenza vaccine. Participants will be asked to complete 5 study visits and 3 telephone~     contacts. Study procedures include blood draws. The duration of participation is about 6~     months.~   "
213431|NCT00766272|"~     Multiple sclerosis is a degenerative disease that affects more than 400,000 people in the US~     alone. MS is in fact the most common disabling neurological disorder in young adults.~     Symptoms of the disease can include problems with balance, walking, fatigue, weakness and~     vision. Over 85% of people with Multiple Sclerosis have problems walking. This can cause them~     to fall or have a constant fear of falling. To prevent falling, MS patients rely on~     equipment, such as walkers and canes. These costs can cause financial difficulties for MS~     patients and families.~      A significant problem that is only recently being studied is the relationship between falling~     and MS. Recent studies have shown that MS patients fall more often than those without MS, and~     also fall more than the elderly population. The consequent fear of falling is also an~     important problem, as those worried about falling will probably change their daily habits to~     lower their risk. This can mean keeping from certain physical and social activities or even~     staying indoors. Thus, falls and fear of falling can have negative medical, physical,~     psychological, and social consequences for the patient.~      Improving patients' walking may help reduce falls and the fear of falling. Treadmill training~     has been shown to improve walking in patients with MS and to lower their risk of falling. One~     way to train patients on a treadmill is with the use of robots that can help move their limbs~     in a more normal way. This kind of robot-assisted treadmill training may provide even greater~     benefits than treadmill training alone.~      The study is expected to last 6-7.5 months. One group of participants will receive weekly~     telephone calls and will be asked questions on other physical activities, falls, and activity~     limitations the patient had during the week. Participants assigned to robot-assisted~     treadmill training will receive twice weekly training session for 8 weeks, for a total of 16~     sessions. Each session will last about 65 to 90 minutes.~      The goal of this study is to see if robot-assisted treadmill training will reduce falls and~     fear of falling in patients with MS. Robot-assisted treadmill training has been shown to be~     effective in reducing falls and fear of falling in Parkinson's disease patients. This type of~     training has not been tested in patients with Multiple Sclerosis. The proposed study will~     help to address this gap and also provide additional data on other possible improvements due~     to robot-assisted treadmill training including ambulation, social participation, fatigue, and~     balance.~   "
213432|NCT00766259|"~     Inpatients will be prospectively have nares screened and MRSA strains collected. All clinical~     MRSA strains of patients will also be prospectively collected. A sensitive strain~     discrimination test of spa typing will be used to determine if the strains are related.~     Hypotheses are~        1. Strain colonization durations vary and may be very short in days to weeks.~        2. Colonizing strains rarely infect 3) Both 1 and 2 may be affected by the patient's~          co-morbidity.~   "
213434|NCT00766233|"~     Hyperthermia - a warming of the tumor at 42-43 ° C - in combination with radiation and / or~     chemotherapy is a proven method of treatment for malignant tumors. The amplification of the~     effect of radiotherapy and various chemotherapeutic agents (platinum analogues, nitrogen-Lost~     derivatives, cytotoxic antibiotics) is experimentally demonstrated. Randomized clinical~     trials have shown a better chance of survival and better local tumor control without~     increasing the toxicity of combined treatment especially also in children's tumors. The~     combination of hyperthermia and radiation therapy is more effective than radiotherapy alone.~     Hyperthermal temperatures increase blood circulation in tumors as a response to stimulation~     with heat. Tumor tissue, having a minor circulation and being acidotic, is resistant to~     radiotherapy, but sensitive to hyperthermia, while tumor with a high blood flow is~     sensitivity to radiation. This positive interaction is a compelling reason for the~     combination of hyperthermia and ionized radiation.~      Hyperthermia, in combination with chemotherapy, increases the concentration of cytostatics in~     the tumor region, raising blood flow caused by warmth. In addition, hyperthermia increases~     toxicity of drugs in cells, being normally resistant to many drugs. Hyperthermia can~     synergistically be combined with chemotherapy treating high risk - tumors with curative~     intention.~      In addition to the clinical use of surface hyperthermia (BSD 500 - O), with appropriate~     treatment of tumors up to 3 cm deep from the surface of the body with established indications~     and palliative indication in advanced stages of cancer, a prospective, randomized study with~     quality-controlled thermometry shall establish the optimal sequence of Hyperthermia in~     combination with irradiation. Therefore the treatment sequence of once per weeks is compared~     to a sequence of three times per week.~   "
213435|NCT00766220|"~     The goal of this clinical research study is to find out what effects radioactive particles,~     SIR-spheres, have when injected into the liver, followed by systemic chemotherapy with a~     combination of cetuximab and irinotecan compared to those who have systemic therapy alone, in~     patients with colon cancer that has metastasized to the liver. The safety of this treatment~     and how well it controls the disease will also be studied.~   "
213436|NCT00766207|"~     This study will use a factorial design randomized controlled trial to (1)compare~     multi-faceted decision support (intervention) to streamlined clinical alerts (control) and~     (2) evaluate whether collecting information about women's risk of pregnancy using a networked~     tablet computer (intervention) is superior to the way clinicians usually collect this~     information (control).~      Over the course of 1 year, we will abstract data from the electronic medical record when~     study clinicians prescribe teratogenic medications, conduct phone interviews with women~     prescribed medications by participating clinicians, and survey participating clinicians about~     their satisfaction with the decision support they receive. We will use this data to confirm~     our hypotheses that clinicians in the intervention groups will (1) prescribe fewer~     teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic~     medication is prescribed, (3) have more patients report satisfaction with the counseling they~     received, and (4) report more satisfaction with the decision support they received.~   "
213437|NCT00766194|"~     This study will measure nasopharyngeal pressure in neonates using a miniature high resolution~     catheter-tip pressure transducer. Any neonatal intensive care patient being treated with~     nasal respiratory support (e.g., nasal continuous positive airway pressure, nasal cannula~     flow either high (>1 LPM) or low (<1 LPM), and nasal prong ventilation either intermittent~     mandatory or high-frequency) will be eligible for study. The catheter-tip transducer will be~     placed within a standard gavage feeding tube catheter and introduced through the mouth into~     the posterior nasopharynx where continuous measurements will be made over 15 minutes. The 15~     minute recording will be divided into 5 three minute segments, including a baseline recording~     at the ordered settings of pressure or flow, a recording at 1 level above baseline, a~     recording back at baseline, a recording 1 level below baseline, and a final segment back at~     baseline. The order of increase-decrease or decrease-increase from baseline will be by random~     sequence. Measurements may be repeated with any change in nasal gas flow or pressure ordered~     for patient care. These measurements will be used to correlate the ordered nasal respiratory~     support therapy with the actual upper airway pressure created by the therapy.~   "
213438|NCT00766181|"~     The purpose of this study is to determine the satisfaction among parents and nurses of~     pediatric patients with IV catheter placement in the Emergency Department.~   "
213439|NCT00766168|"~     The purpose of this study is to establish the substantial equivalence of the HDS HI 1.54™ to~     the paflufocon C material control lenses to correct myopia and hyperopia with and without~     astigmatism. The purpose of the study is to profile the outcome endpoints and the patient~     acceptance of this Class II medical device.~   "
213440|NCT00766155|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of~     radiation directly on the tumor may kill more tumor cells and have fewer side effects. Giving~     chemotherapy together with radiation therapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after~     surgery may kill any tumor cells that remain after surgery. It is not yet known whether~     capecitabine is more effective with or without oxaliplatin in treating patients with rectal~     cancer.~      PURPOSE: This randomized phase III trial is studying giving chemotherapy together with~     radiation therapy before surgery followed by capecitabine with or without oxaliplatin to see~     how well it works in treating patients with locally advanced rectal cancer.~   "
213441|NCT00766142|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Giving more than~     one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab~     works in treating patients undergoing surgery to remove peritoneal carcinomatosis from~     colorectal cancer.~   "
213442|NCT00766129|"~     Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary~     arteries. There are several kinds of DES i.e. eluting the drug either from stable or~     biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of~     our study was to compare safety and efficacy of implantation of two different types of stents~     eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent)~     into coronary artery by-pass graft.~   "
213443|NCT00766116|"~     This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in~     the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that~     has come back after treatment.~   "
213444|NCT00766103|"~     Incidence of hypo- and hypercarbia during induced hypothermia after cardiac arrest is high.~     The original report from HACA-group reported that hypothermia treated patients had improved~     survival and neurological outcome. Suprisingly, in that trial normocarbia was not achieved~     even though the aim was set for ventilatory support as normoventilation. This study aims to~     investigate the effects of mild hypo- and hypercarbia on cerebral perfusion (blood flow,~     intracranial pressure) and metabolism (microdialysate metabolites). We hypothesize that~     uncontrolled ventilatory suppport may render the patients in risk of exacerbation of neuronal~     damage, conversely, further improvement in outcome may be achieved with succesfull~     ventilatory management. We intend to enroll 10 out-of-hospital cardiac arrest patients~     succesfully resuscitated and subsequently treated with controlled hypothermia for 24 hours.~     The patients in need of anticoagulation are excluded. We plan to induce mild hypocarbia and~     hypercarbia during and after induced hypothermia. Metabolic and perfusion data are collected~     with clinically used methods such as transcranial doppler, intracranial pressure measurement,~     near infrared spectroscopy, jugular bulb, intracerebral microdialysis).~   "
213445|NCT00766090|"~     The purpose of this study is to compare once and twice daily GW685698 in asthma~   "
213446|NCT00766077|"~     Stress fractures are a common and debilitating injury for a variety of athletes however~     current evidence does not clearly allow easy prediction of athletes at risk for a first~     fracture. Animal and some preliminary human evidence suggest that assessment of bone~     strength, muscle size and running mechanics may be primary risk factors for stress fractures.~     The investigators study will help determine which, if any, of these modifiable risk factors~     could help identify athletes at risk for stress fracture.~      Competitive female distance runners will be recruited for this study. Participants will~     placed into a stress fracture or control group based on stress fracture history. Dual energy~     x-ray absorptiometry (DXA) and peripheral Quantitative Computed Tomography (pQCT) will be~     used to assess bone structure and strength. Running mechanics will be assessed during a 30-40~     minute fatiguing run. A treadmill with an embedded force plate and high speed video will be~     used to assess changes in running mechanics throughout the run.~      The purpose of this project will be to~        1. explore differences in volumetric bone mineral density (vBMD), bone geometry, and muscle~          cross sectional area (MCSA) using pQCT~        2. explore changes in load (GRFs) and running mechanics that occur during a fatiguing run~          in runners with and without a history of stress fracture.~   "
213447|NCT00766064|"~     Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment~     response to pharmacological interventions has been modest for these patients. Chronic~     elevated anxiety and associated psychophysiological parameters including increased heart rate~     and alterations in skin conductance are key symptoms of chronic PTSD. Antidepressants,~     including selective serotonin reuptake inhibitors (SRIs) or norepinephrine-serotonin~     re-uptake inhibitors are considered treatment of first choice for these patients, however a~     substantial portion of patients do not respond sufficiently (Zhang and Davidson 2007).~     Therefore, there is a need to establish novel and effective add-on treatment strategies for~     these patients. Recently, atypical neuroleptics have received considerable attention since it~     was shown in multiple controlled and naturalistic trials that these medications are an~     effective treatment option for patients with PTSD (Davis et al 2006). In chronic PTSD, the~     psychophysiological responses at baseline and in response to treatment have yet been~     inadequately studied and may provide novel insight into antidepressant and anxiolytic~     mechanisms of medications used in the treatment of PTSD. Therefore, in addition to evaluating~     the antidepressant and anxiolytic effects of paliperidone, a novel atypical neuroleptic, in~     the treatment of PTSD, we also aim to compare neurophysiological responses at baseline with~     post-treatment effects in antidepressant-refractory PTSD patients.~      Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of paliperidone in patients~     with PTSD.~      Secondary Aim 2: Evaluate the effects of paliperidone on fear conditioned psychophysiological~     responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat~     interval) at baseline and after 6 weeks of naturalistic treatment in chronic PTSD patients.~   "
213448|NCT00766051|"~     Many critically ill newborns in the neonatal intensive care (NICU) or critical care unit~     (NCCU) environment develop feeding and movement problems. The purpose of this study was to~     determine the extent to which neurophysiologically based occupational therapy intervention~     (NBOTI) for NCCU infants would affect the intervention group's oral feeding and other~     covariates, such as heart rate variability (HRV) during feeding. The biopsychosocial model~     provided the study's conceptual framework. The key research question explored whether NBOTI~     in the NCCU promoted healthy infant development through feeding, movement organization, and~     parent self-efficacy. This exploratory study with 10 NCCU infants and 10 historical matched~     controls utilized a mixed method design of qualitatively coded video analysis and inferential~     statistics such as the t test, the binomial test, hierarchal linear modeling (HLM), and~     multivariate analysis. Significant differences were obtained between the intervention and~     comparison groups in the number of days from all tube to all oral feeding before discharge~     and speed at which the infants gained weight. Longitudinal analyses of the intervention group~     data were employed to reveal significant trends and pre/post differences in the HRV data~     along with how quickly the infants ate, parent perceptions of self efficacy and decreased~     stress in the NCCU. Finally, qualitative findings obtained from videotape analysis provide~     further evidence that NBOTI was effective in facilitating feeding and promoting development.~     The recommendations are to replicate this study to validate and expand the findings of the~     current study. The model for infant care suggested by the findings could contribute to~     positive social change by fostering positive physical and emotional child development and~     healthy child-parent and family-caregiver relationships.~   "
213449|NCT00766038|"~     Growth Hormone (GH) deficiency, defined by insufficient GH response to a variety of~     stimulating compounds, is found in 20-35% of adults who suffer traumatic brain injuries (TBI)~     requiring inpatient rehabilitation1. However, there is no accepted gold standard for~     diagnosing GH deficiency in this population. Further, the major effector molecule of the~     somatotropic axis, Insulin-Like Growth Factor-1 (IGF-1) has recently been recognized as an~     important neurotrophic agent. Since most repair and regeneration after TBI occurs within the~     first few months after injury, absolute or relative deficiencies of GH and IGF-1 in the~     subacute period after TBI are potentially important factors why some patients fail to make a~     good functional recovery. The proposed study is a randomized, double-blind,~     placebo-controlled trial of rhGH, starting at 1 month post TBI, continuing for 6 months.~      This study has one primary hypothesis, that treatment with recombinant human Growth Hormone~     (rhGH) in the subacute period after TBI results in improved functional outcome 6 months after~     injury. As secondary hypotheses, we will investigate what is the optimal method to diagnose~     GH deficiency in TBI survivors and study the relationship between GH deficiency and~     insufficiency and functional recovery.~   "
213450|NCT00766025|"~     The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor~     and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium.~   "
213467|NCT00765804|"~     The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of~     dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in~     patients with dry eye.~   "
213521|NCT00765102|"~     This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the~     efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple~     myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one~     of two strata, bortezomib-resistant or bortezomib non-resistant.~   "
213451|NCT00766012|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive~     multiple-ascending panels are planned. Subjects will start with an initial single dose that~     is followed by a wash-out period of 48 hours to adequately define the single-dose~     pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended~     to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once~     daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to~     receive either AZD2066 or placebo.~   "
213452|NCT00765999|"~     The objective of this study is to assess the long-term safety of linaclotide administered to~     patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C)~   "
213453|NCT00765986|"~     Non-small cell lung cancer (NSCLC) has a poor prognosis if not caught early enough. One of~     the factors that may impact the ability to control NSCLC is low oxygen levels (hypoxia)~     inside the tumour. This study will use 18F-FAZA PET scans to assess whether patients have~     hypoxic tumours and to monitor the changes to the hypoxic areas of a tumour during currently~     available standard treatment. It is hypothesized that 18F-FAZA PET may predict response to~     treatment, local control, and/or survival in NSCLC.~   "
213454|NCT00765973|"~     A multi-center, open-label, two-arm, dose-escalation study to establish the safety,~     tolerability, MTD, and schedule of TLI administered intravenously as a 30 minute infusion in~     adult subjects with advanced solid tumors that have relapsed, are refractory to standard~     therapy, or for whom there is no standard therapy available.~      The two dosing regimens to be evaluated are:~        -  Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)~        -  Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)~      When one of the two arms reaches MTD, all future subjects will then be enrolled in the~     remaining study arm until MTD of that arm is reached.~   "
213455|NCT00765960|"~     The purpose of this study is to assess the efficacy, predictability and safety of the~     Advanced CustomVue™ iLASIK procedure (WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser~     System and IntraLase™ FS System).~   "
213456|NCT00765947|"~     This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood~     pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting~     Systolic Blood Pressure [msSBP] ≥ 140 mmHg and < 180 mmHg and/or mean sitting Diastolic Blood~     Pressure [msDBP] ≥ 90 and <110 mmHg).~   "
213457|NCT00765934|"~     There is an increasing awareness of the importance of treating procedure-related pain.~     Patients undergoing vascular access procedures are often afraid of needles and the discomfort~     associated with injections. This type of pain and/or fear can be stressful to patients. [1]~     For prevention of the pain associated with these procedures, the hospital is using Rapydan~     plasters. Rapydan consists out of two local anesthetics: lidocaine and tetracaïne. Rapydan~     produces topical anesthesia after an application time of 30 minutes and is used in the~     Martini Hospital for pain relieve by venipuncture and IV cannulation. The venous blood~     draining the anaesthetized skin contains a higher blood concentration of the local~     anesthetics than does venous blood in other parts of the body [2] Although the concentrations~     of the local anesthetics are low in patients with normal skin, the question is whether the~     presence of the local anesthetics which Rapydan contains might influence routine measurements~     in clinical chemistry and hematology.~   "
213458|NCT00765921|"~     The purpose of the study is to investigate the safety and tolerability of the anti-VEGF~     (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton~     beam irradiation for the treatment of choroidal melanoma by determining the incidence and~     severity of ocular adverse events. Systemic adverse events will also be evaluated. A~     secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications~     that can occur after irradiation.~   "
213459|NCT00765908|"~     This study aims to assess the potential for ischaemic peri-conditioning (IP) in elective~     percutaneous coronary intervention (PCI) patients to attenuate ischaemia in an animal model~     of myocardial infarct.~   "
213460|NCT00765895|"~     The principal objective of this multicenter, randomized, placebo-controlled trial is to~     evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared~     with placebo.~   "
213461|NCT00765882|"~     The objective of this trial is to determine the efficacy and safety of linaclotide~     administered to patients with chronic constipation (CC). The primary efficacy parameter is~     the percentage of patients in each treatment group that meet the protocol definition for~     Complete Spontaneous Bowel Movement (CSBM) Overall Responder~   "
213462|NCT00765869|"~     The purpose of this study is to evaluate a decision aid (written information booklet designed~     to facilitate informed decision making) to help people aged 55-64 years, with low levels of~     education and literacy, make an informed choice about bowel cancer screening, using faecal~     occult blood testing.~   "
213463|NCT00765856|"~     Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the~     Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every~     12 hours. Dosing adjustments will be based on the review of the subject's pain scores.~     Oxymorphone IR 5 mg will be provided to be used as supplemental breakthrough pain~     medication (as needed). Titration Period will end when the fixed dose of study medication is~     tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the~     open-label 3-month maintenance period on the fixed dose of study medication established~     during the Titration Period.~   "
213464|NCT00765843|"~     This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly~     prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate~     the reduction in heel pain associated with three types of orthoses. It is hypothesized that~     custom made orthoses will significantly decrease pain and improve foot function in comparison~     to prefabricated insoles and sham insoles.~   "
213465|NCT00765830|"~     This clinical trial is designed to provide additional information on the safety and~     tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2~     diabetes mellitus (T2DM) and moderate or severe renal insufficiency~   "
213466|NCT00765817|"~     This study will compare the efficacy and safety of exenatide versus placebo in adults whose~     diabetes is not fully controlled by insulin glargine with or without metformin and/or~     pioglitazone.~   "
213468|NCT00765791|"~     Many types of head and neck cancers will have local spread to the neck. As such selective~     neck dissection is performed as part of the treatment. The neck is divided into various~     levels. Selective neck dissection targets areas that are most likely to harbor cancer cells~     for specific types of head and neck cancers. Level IIB has been particularly controversial in~     the last few years, as the rate of cancer spread to this area has been shown to be quite low~     (0-8%). Moreover, because the spinal accessory nerve (involved in shoulder function) runs~     through this area, there is theoretical risk of causing post-operative shoulder weakness. As~     such, the question of whether removing level IIB, knowing that there is low chance of it~     containing disease spread, is worth risking decreased shoulder function. Some would argue~     that all potential diseased sites should be removed at all costs. While other advocate that a~     balance between disease cure and function should be maintained. However, what needs to be~     determined is just what impact does dissecting IIB have on shoulder function. At our~     institution, the rate of poor shoulder function associated with selective neck dissection has~     been perceived as being quite low. This study is designed to test this observation.~      Hypothesis: Neck dissection including level IIb in head and neck cancer patients will not~     lead to worse shoulder function and quality of life than when level IIb is preserved.~   "
213469|NCT00765778|"~     Detailed activity:~        -  Family members and caregivers of carrier residents will be screened for ESBL and MRSA.~          Screening will be performed by obtaining nares and perirectal cultures. Nares cultures~          will be obtained by ward staff or research personnel who are experienced in performing~          this activity: a moisture swab will be applied gently to the distal part of both nares.~          Perirectal cultures, will be taken by swab, who will be applied to the perirectal area,~          either by staff as mentioned above, or will be given to the participants to perform by~          himself (with explanation on how to perform it).~        -  The Family and Caregiver Screening Form will be filled out; results of screening will be~          added to the forms. This data will be stored after removal of all Family members'~          identifiers for further analysis.~        -  In order to allow follow up, a list linking between the Family members' study number and~          his identifying details will be kept separately in the rehabilitation center. This list~          will not be transferred elsewhere.~   "
213470|NCT00765765|"~     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Hydroxychloroquine may help ixabepilone work better by making tumor cells more sensitive to~     the drug.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone~     given together with hydroxychloroquine and to see how well they work in treating patients~     with metastatic breast cancer.~   "
213471|NCT00765752|"~     Disturbances in the amino acid neurotransmitter (AANt), gamma-amino butyric acid (GABA)~     function are hypothesized to contribute to the neurobiology of Major Depressive Disorder~     (MDD) and insomnia. The principal objective of this project is to use magnetic resonance~     spectroscopy (MRS) to provide the first in vivo characterization of cortical GABA levels in~     individuals with primary insomnia, and to determine whether subjects with MDD, achieving a~     partial response with selective serotonin reuptake inhibitor treatment but still experiencing~     significant residual symptoms including insomnia, have altered levels of this~     neurotransmitter. The investigators are also exploring the correlation between cortical AANt~     levels and abnormalities in sleep parameters in primary insomnia and as a residual symptom of~     major depression.~   "
213472|NCT00765739|"~     The purpose of this project is to test the effectiveness of neuromuscular electrical~     stimulation (NMES) that produces 40 % of maximum voluntary contraction (MVC) in increasing~     muscle size and improvement in muscle force output within the thigh muscle of elderly people.~   "
213473|NCT00765726|"~     The purpose of this study is to collect safety information associated with the use of Xyntha~     in a usual care setting. Upon meeting eligibility criteria, patients will be required to have~     approximately 5 study visits over a 2 year period. Procedures completed throughout the study~     include collection of vital signs, physical exams, and laboratory assessments. Patients will~     be required to complete an infusion log for each Xyntha infusion.~   "
213474|NCT00765713|"~     Hypothesis:~      The CPAP treatment diminishes the effect of ventricular arrhythmias in patients with ischemic~     heart disease or dilated myocardiopathy, systolic ventricular disfunction and sleep~     apnea-hypopnea syndrome (SAHS)Objectives: To analyze the incidence of ventricular arrhythmias~     (premature ventricular beat, non-sustained ventricular tachycardia and sustained ventricular~     tachycardia) and appropriate defibrillator therapies in patients with ischemic heart disease~     or dilated myocardiopathy, moderate-severe left ventricular dysfunction,with an implantable~     cardioverter-defibrillator (ICD) and sleep apnea. To study the effect of CPAP on the cardiac~     arrhythmias and on the number of appropriate defibrillator therapies.~      Design:~      Parallel, randomized and single-blinded multicentric study to compare CPAP vs.~     hygienic-dietetic recommendations.~      Patients with SAHS (AHI≥15) and systolic left ventricle dysfunction patients with an ICD.~      Duration: 24 months.~   "
213475|NCT00765700|"~     Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting~     of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment~     of acute musculoskeletal pain.~   "
213476|NCT00765687|"~     A multicenter Prospective Study to assess the screening methods, parameter of NTX and the~     efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in~     patients of non-small cell cancer with bone metastasis in china.~   "
213477|NCT00765674|"~     This study evaluated the efficacy (blood pressure lowering effect) and safety of~     aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.~   "
213490|NCT00765505|"~     This project will provide novel information concerning the ability of exercise to enhance the~     capacity for oxidative metabolism of fatty acids and improve insulin resistance in older~     adults who are at high risk for the development of type 2 diabetes. Ultimately this may help~     identify mechanisms and therapeutic targets implicated in skeletal muscle metabolic~     dysregulation. The proposed study is to conduct a randomized controlled exercise training~     intervention trial in older men and women. In addition, the response to exercise in these~     subjects will be compared to those of highly endurance-trained, age-matched athletes.~   "
213491|NCT00765492|"~     This is a study to evaluate safety, tolerability, PK and PD effects of orally administered~     AZD8529 after multiple ascending doses~   "
213478|NCT00765661|"~     The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of~     medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf®~     capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a~     transplanted kidney. LCP-Tacro is a tablet containing the same active ingredient (tacrolimus)~     that is in Prograf capsules, but the tablet has been designed to release tacrolimus over an~     extended period so that it only has to be taken once daily. LCP-Tacro is an investigational~     drug.~      This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a~     kidney transplant in patients randomly assigned (by chance, like flipping a coin) to take~     either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In~     addition, patients will remain on study drug for 360 days in order to evaluate the relative~     safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.~   "
213479|NCT00765648|"~     The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol~     administered intravenously for the management of hypertension in the emergency department~     setting.~   "
213480|NCT00765635|"~     Accumulation of cerumen in the external ear canal is a common problem. The presence of~     cerumen not only interferes with the clinician's view of the tympanic membrane, but may also~     result in hearing loss and vertigo, and may predispose to ear infections.~      Removal of cerumen is facilitated by the use of a variety of ceruminolytics, or wax solvents.~     The current study was designed to evaluate the ceruminolytic effects of a single, brief~     application of the two most frequently used products in the investigators area, containing~     chlorobutanol or potassium carbonate with or without irrigation in the primary care setting~     in a randomized, single-blind trial. To our knowledge, this is the first randomized study~     comparing ceruminolytics with chlorobutanol versus potassium carbonate.~   "
213481|NCT00765622|"~     The purpose of this study is to demonstrate the importance of functional assessment of the~     pelvic floor (AFA) in older women, as prognostic factor for Urinary Incontinence (UI).~   "
213482|NCT00765609|"~     The Paediatric Analgesia Slide is a device developed for parents. Its development follows~     research into the Paediatric Analgesia Wheel, a device intended for use by hospital doctors.~     Previous research has shown the benefit of using aids such as the Paediatric Analgesia Wheel~     when simulating prescribing to children in hospital.~      At present, it is unknown whether this concept can be extended to use by parents when~     administering paracetamol to their children at home.~   "
213483|NCT00765596|"~     The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric~     bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the~     early post-operative period following feeding in morbidly obese subjects.~   "
213484|NCT00765583|"~     A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with~     Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of~     the face at month 4.5 and on the other side of the face at month 9. Both sides of the face~     will then be treated again at month 18. The subjects will evaluate themselves and will also~     be evaluated by the treating doctor and a blinded evaluator (a person that does not know when~     the different sides of the face are treated). Side effects and medications taken during the~     study will also be recorded.~   "
213485|NCT00765570|"~     Expand clinical literature on the use of Grid radiation with conventional external beam~     therapy. Vast majority of therapy is for palliative care to provide relief from pain, but has~     also shown a reduction in the size of tumor mass.~   "
213486|NCT00765557|"~     We hypothesize fecal retention is the primary source of bladder dysfunction in some children~     with Urge Syndrome. Our specific aims are:~        1. To test this hypothesis through a prospective, randomized, double-blinded and~          placebo-controlled trial of laxatives for children diagnosed with US.~        2. To determine if a validated questionnaire of bowel activity administered to the family,~          and when appropriate, the patient, will identify those likely to benefit from laxative~          therapy for bladder dysfunction.~        3. To determine if the abdominal X-Ray of the kidneys, ureters and bladder (KUB) assessment~          of fecal loading corresponds to answers on the questionnaire regarding incidence of~          constipation, and/or response to laxative therapy for US.~   "
213487|NCT00765544|"~     The presence of foot drop limits normal gait. Our prior data has suggested that approximately~     30% of MS patients have foot drop. Although we have observed that task-specific~     rehabilitation using the Lokomat can improve ambulation in chronic MS patients, subjects with~     foot drop have difficulty translating task-specific training to normative gait patterns~     over ground, despite improving speed and endurance.~      One of the key limitations of the Lokomat is a lack of robot-assisted training for the ankle~     joint. The Anklebot, an MIT-developed rehabilitation robot for the ankle, has the potential~     to address this. The device can move throughout three planes and train ankle flexion,~     extension, inversion and eversion; however, therapy with the Anklebot alone does not train~     the knee or hip.~      We plan to test whether subject foot drop and overall gait benefit more from Anklebot therapy~     alone or a combination of Anklebot and Lokomat.~   "
213488|NCT00765531|"~     The hypothesis of this study proposal is that pediatric urinary stone formers have genetic~     risk factors which predispose their urinary stone production. 50-60% of pediatric stone~     patients have a positive family history of urinary stone disease. Several genetic mutations~     have been identified which predispose patients to various types of urinary stones. These~     genetic mutations can also lead to other significant sequela besides stones, including~     osteopenia/osteoporosis (bone loss). Furthermore, metabolic abnormalities can be identified~     in more than 50% of pediatric stone formers, some of which can be improved/alleviated with~     medical intervention to help decrease rate of stone formation and the need for~     hospitalization and surgical intervention.~   "
213489|NCT00765518|"~     This study is designed to assess the safety and tolerability of Cardiac Repair Cells (CRCs)~     compared to standard-of-care in patients with dilated cardiomyopathy (DCM).~   "
213492|NCT00765479|"~     RATIONALE: Soy protein may help prevent prostate cancer recurrence in patients who have~     undergone surgery for prostate cancer.~      PURPOSE: This randomized phase II/III trial is studying how well soy protein works and~     compares it to a placebo in preventing recurrent cancer in patients who have undergone~     surgery for stage II prostate cancer.~   "
213920|NCT00759811|"~     The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity~     in patients with symptomatic ischemic heart failure.~   "
213493|NCT00765466|"~     This is an open label, Phase II, multi-center study designed to evaluate the effect of AVR118~     when administered to patients with systemic symptoms related to recurrent or metastatic~     cancers who may or may not be undergoing anti-cancer treatment. During the initial, induction~     treatment phase of the study, AVR118, 4.0 mL, will be given subcutaneously each day for 28~     days. Patients who respond to the trial period dosing will be eligible to continue on AVR118~     if they and their physicians believe it would be beneficial, and if no safety concerns are~     raised.~   "
213494|NCT00765453|"~     Study hypothesis :~      The purpose of this study is to determine whether Intracoronary infusion of autologous bone~     marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior~     myocardial infarction will lead to an improvement in cardiac function greater than that seen~     by placebo alone.~      Aims~        -  To demonstrate that it is safe and feasible to deliver autologous bone marrow derived~          stem cells within hours of the primary angioplasty procedure~        -  To demonstrate the effects of autologous bone marrow derived stem cells on cardiac~          function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.~        -  To demonstrate the effect of autologous bone marrow derived stem cells in addition to~          standard care leads to improvement in cardiac function compared to patients~          saline(placebo) and standard care.~   "
213495|NCT00765440|"~     RATIONALE: It is not yet known which regimen of enteral nutrition is more effective in~     preventing infections in patients undergoing surgery for cancer of the upper aerodigestive~     tract.~      PURPOSE: This randomized phase III trial is comparing three nutrition regimens in treating~     patients with cancer of the upper aerodigestive tract.~   "
213496|NCT00765427|"~     Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety~     observation.~   "
213497|NCT00765414|"~     This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in a~     single patient with infantile-onset Pompe disease who were previously treated with rhGAA in a~     Genzyme study.~   "
213498|NCT00765401|"~     Cystic fibrosis (CF) is the most common lethal autosomal recessive disease among Caucasians.~     While the pulmonary disease in CF receives most of the attention, gastrointestinal diseases~     occur in >95% of CF individuals and can contribute to significant morbidity, mortality and a~     decreased quality of life. The abdominal pain in CF is usual chronic in nature, and the~     etiology is not usually found, despite medical testing for standard causes of abdominal pain.~     Helicobacter pylori (Hp) is increasingly being recognized as the etiology of peptic ulcer~     disease and other upper and lower gastrointestinal tract diseases.1 The role that Hp plays in~     CF abdominal pain has not been elucidated.~      Our long-term goal is to understand relationship between chronic HP infection and abdominal~     pain in pediatric CF patients.~      The specific objective of this proposal is to utilize current state-of-the-art testing for HP~     to determine the prevalence of Hp in our CF patients age 5 and older.~      The central hypothesis is that Cystic fibrosis subjects with significant abdominal pain will~     have an increased incidence of Helicobacter pylori as determined by the urea breath test and~     stool antigen test.~      The rationale for the proposed research is that once we elucidate a causal relationship~     between CF patients with abdominal pain and Hp, we can begin treatment of this infection to~     improve quality of life.~   "
213499|NCT00765388|"~     Background Urostomy is a surgical procedure that detours or diverts urine away form a~     diseased or defective bladder. The bladder can be removed and the urine is passed out of the~     body through an opening (stoma) in the stomach. People with urostomy will not be able to~     start and stop urine coming out through the stoma, so a urostomy bag will be fitted to~     collect the urine as it comes out.~      A urostomy bag consists of an adhesive, which is attached to the skin around the stoma and a~     bag connected to the adhesive to collect the urine.~      It is very important the standard is high on these products; otherwise the user~     (urostomy-patient) will experience lots of problems with the skin around the stoma.~   "
213500|NCT00765375|"~     • To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate~     acne vulgaris defined by the Investigator's Global Assessment (IGA)~   "
213501|NCT00765362|"~     To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.~   "
213502|NCT00765349|"~     REASON FOR STUDY~      Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, suitable~     measurements of a patient's preoperative cardiorespiratory reserve, performed non-invasively~     by cardiopulmonary exercise testing, have been shown to be predictive of outcome following~     non-cardiac surgery. Although the exact mechanisms behind poor reserve in this population are~     unknown, poor cardiac function and particularly diastolic dysfunction are likely to be~     important.~      AIMS~      The aim of the present study is to investigate the role of diastolic dysfunction in~     determining poor cardiorespiratory reserve in elderly patients undergoing major non-cardiac~     surgery. This will provide suitable information to inform a further therapeutic preoperative~     interventional study.~      OBJECTIVES AND METHODS~        1. To determine the presence and severity of diastolic dysfunction, measured by~          preoperative transthoracic echocardiogram, in a series of elderly surgical patients~          undergoing major elective non-cardiac surgery~        2. To investigate the relationship between diastolic dysfunction and poor cardiorespiratory~          function during and following exercise measured by non-invasive testing including~          cardiopulmonary exercise testing, non-invasive blood pressure measurements and~          biochemical analysis~        3. To determine whether patients with poor diastolic dysfunction are likely to have worse~          outcomes following major surgery compared with those who show no evidence of diastolic~          dysfunction. Outcomes will be measured in terms of length of hospital stay and early~          postoperative morbidity (validated scoring system) and mortality.~   "
213517|NCT00765154|"~     The purpose of the study is to examine the effects of switching from antiretroviral~     combinations that includes efavirenz (Sustiva®), lopinavir/ritonavir (Kaletra®) or~     atazanavir/ritonavir (Reyataz®/Norvir®) in individuals experiencing side effects from one of~     these agents, and replacing these with a new HIV medication called Darunavir also given with~     ritonavir (Norvir®).~      The study will primarily investigate the effect of change in medication on the subjects viral~     load (the levels of the HIV virus in the blood), on immunological parameters (CD4 count) and~     on other safety parameters (such as cholesterol) and also quality of life.~   "
213518|NCT00765141|"~     The intent of this protocol is to salvage human-related material that is normally destined~     for destruction, so it can be used in infection-related scientific studies.~   "
213503|NCT00765336|"~     Researchers want to find out how Minocycline Extended-Release Tablets affect sperm-production~     in healthy males.~      The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of~     minocycline, compared with a placebo or inactive pill.~      Approximately 170 healthy adult males will be assigned by chance (like flipping a coin) to 2~     treatment groups with approximately 85 subjects per group. You will be treated with either~     Minocycline Extended-Release Tablets or placebo once daily. Screening will occur within 14~     days prior to the first dose of study drug.~      Required study activities include:~        -  Written informed consent~        -  Weight~        -  Two semen collections within 48-72 hours of one another at the screening visit and Days~          84,112, 140, and 168~        -  Blood draws at the screening visit and Days 84, 112, 140, and 168~        -  Genital examination (excluding prostate) at screening and at the Day 84 and Day 112~          visits~        -  Medical history~      You will continue in the treatment phase of the study for 12 weeks.~      You will return to the clinic 4 weeks and 8 weeks after completion of the treatment phase of~     the study, with the final study visit approximately 12 weeks after the last dose.~      Participation will be for 24-weeks.~      Up to 10 investigational sites will enroll subjects into the study.~   "
213504|NCT00765323|"~     Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with~     acromegaly that were previously treated with octreotide depot.~   "
213505|NCT00765310|"~     The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to~     reduce risk factors such as body weight and high blood cholesterol levels in overweight or~     obese participants.~   "
213506|NCT00765297|"~     Because the increasing fall problem, mainly due to an impaired gait and balance ability and~     partly caused by trips, this study will investigate fall risk by detecting fall related~     movement characteristics and by detecting stumbles inclusive the compensation mechanism to~     recover from the trip. Based on the promising results using accelerometry for accurate and~     objective gait analysis, fall risk will be measured in younger and older (>60y) subjects~     using a triaxial accelerometer.~   "
213507|NCT00765284|"~     To determine whether 8 weeks of Niaspan treatment increases cholesterol efflux in male~     subjects with low HDL-C cholesterol when compared to no treatment.~      To determine whether 8 weeks of Niaspan treatment increases fecal cholesterol excretion when~     compared to no treatment.~      To determine whether 8 weeks of Niaspan treatment increases the rate of global reverse~     cholesterol transport when compared to no treatment.~   "
213508|NCT00765271|"~     The study is being conducted as we have found that many patients with Human Immunodeficiency~     Disease (HIV) require a combination of different drugs to treat the HIV infection. Before~     using different combination of drugs, it is important to do studies to see if the drugs will~     affect the activity of one another.~      The study aims to help us understand if darunavir/ritonavir or raltegravir have any effects~     on levels of abacavir in the blood.~      The purpose of the study is to assess the pharmacokinetics (how a drug is absorbed,~     distributed and eliminated from your body) of abacavir in the absence and in the presence of~     darunavir/ritonavir and raltegravir.~   "
213509|NCT00765258|"~     To examine, through retrospective and prospective chart review, the difference in pain and~     mobility, pre and post treatment, as assessed by the patient's completion of the VAS pain~     scale and Roland Morris Disability Questionnaire (RMDQ).~      CT fluoroscopy guidance during percutaneous sacroplasty is an effective treatment for~     sacro-iliac insufficiency fractures resulting in rapid reduction of pain and improved~     mobility in patients. This can be effectively assessed using the VAS pain scale and RMDQ both~     pre and post procedure.~   "
213510|NCT00765245|"~     RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the~     cancer. It may also stimulate the immune system in different ways and stop cancer cells from~     growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help~     kill them or carry cancer-killing substances to them. It is not yet known whether~     lenalidomide is more effective with or without rituximab in treating diffuse large B-cell~     non-Hodgkin lymphoma.~      PURPOSE: This randomized phase II trial is studying lenalidomide to see how well it works~     when given with or without rituximab after standard chemotherapy in treating patients with~     diffuse large B-cell non-Hodgkin lymphoma.~   "
213511|NCT00765232|"~     The purpose of this study is to determine whether continuous intravenous ketorolac infusion~     reduces pain in patients who are having laparoscopic surgery to donate a kidney.~   "
213512|NCT00765219|"~     The purpose of this study is to determine whether cognitive behavior treatment (CBT) can be~     delivered effectively by providers of different expertise levels in adults age 60 and older~     in a primary care setting.~   "
213513|NCT00765206|"~     Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to~     compare effects on stomach acid; 30 participants will continue treatment for 7 days and will~     have repeat evaluations at Day 7.~   "
213514|NCT00765193|"~     This will be a study where all patients will undergo a two-step procedure:~      Step 1 - Physicians examine the problem area of skin ONLY and record result. Step 2 -~     Physicians perform TBSE and record result. Eventual lesions suggestive of melanoma and~     non-melanoma skin cancers will be recorded after step 1 or step 2 examination and will be~     finally biopsied and histopathologically diagnosed. Exceptions to biopsy may include patients~     with multiple non-melanoma skin cancers (e.g. actinic keratoses or basal cell carcinomas).~      Each center will be provided with an electronic data sheet for patients record, or~     alternatively, with a paper record form.~      Endpoints of the study are new parameters concerning the standard of care for skin cancer~     screening. We expect to conclude that TBSE enables clinicians discovering an increased number~     of skin cancers thus resulting in earlier detection.~   "
213515|NCT00765180|"~     The investigators previously reported that colonoscopy with a transparent retractable~     extension (TRE) device improved the adenoma detection rate without affecting intubation and~     withdrawal times. On the other hand, colonoscopy using narrow band imaging (NBI) is expected~     to lead to higher rate s of adenoma detection. The investigators compared the effects of TRE~     device on colorectal adenoma detection with those of NBI.~   "
213516|NCT00765167|"~     Training and calibration of dental examiners~   "
213519|NCT00765128|"~     The purpose of this study is to determine whether continuous intravenous ketorolac infusion~     reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone~     disease.~   "
213522|NCT00765089|"~     Atrial Fibrillation (AF) is one of the most common postoperative complications after coronary~     artery bypass grafting (CABG). Postoperative AF produces a substantial impact on hospital~     resources with an estimated annual expenditure of over $1 billion. This includes the cost of~     pharmacological treatment and the cost of the increased length of stay. The incidence of AF~     is about 30-40% in CABG patients and increases with age of the patient. As the average age of~     the patient that undergoes CABG surgery is increasing, it is critical to find a way to~     prevent or reduce the incidence of this complication.~      We propose a prospective, randomized, controlled study to determine the role of pulmonary~     vein isolation by bipolar ablation in the prevention or reduction of postoperative AF. The~     block- randomization plan will be used to maintain balance of the study and control arms~     throughout the study.~   "
213523|NCT00765076|"~     This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine~     GSK2186877A in people aged 65 years or older.~   "
213524|NCT00765063|"~     The primary objective of this 6 month open-label extension trial is to evaluate long-term~     safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in~     diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral~     neuropathy.~   "
213525|NCT00765050|"~     The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from~     peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.~      The secondary objectives are:~        -  To determine the safety of the intramuscular administration of CD133+ cells that have~          been mobilized from peripheral blood.~        -  To determine the CD133+ capacity to increase the re-vascularization at lower limbs in~          diabetic patients with critic ischemia in the lower limbs.~        -  To evaluate the patient global health condition using the notified results of the SF-36~          questionnaires completed by patients~   "
213526|NCT00765037|"~     The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse~     Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has~     already begun.~   "
213527|NCT00765024|"~     A prospective controlled trial to compare the efficacy and safety of 7-day albendazole,~     single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic~     strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.~   "
213528|NCT00765011|"~     A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of~     Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment~     With TPF Chemotherapy.~   "
213529|NCT00764998|"~     The purposes of this research study are:~        1. to see if there is a difference in the quantity of protective influenza antibodies~          produced by different doses of the Fluviral vaccine~        2. to see if these different vaccine dosing schedules reduce flu-like illness and/or reduce~          laboratory documented influenza in HIV Infected adults.~   "
213530|NCT00764985|"~     The investigators want to look at how patients admitted after passing out (syncope) or nearly~     passing out (pre-syncope) do after going home and how many of them remain free of symptoms of~     syncope or pre-syncope.~   "
213531|NCT00764972|"~     This is a phase IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes~     that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast~     cancer.~      The investigators are combining these 2 drugs in order to determine if the investigators can~     increase the activity of vinorelbine in metastatic breast cancer patients.~      Patients with measurable metastatic breast cancer without previous chemotherapy for~     metastatic disease are eligible for the protocol. They will be treated with 2 different dose~     levels of sorafenib in order to determine the most tolerable dose.~   "
213532|NCT00764959|"~     The purpose of this study is to evaluate the use and efficacy of the Encore Linear™ Hip~     System in a group of 200 patients for whom data has already been collected.~   "
213533|NCT00764946|"~     A study to test the safety and effect of twice daily raltegravir in a diverse cohort of~     patients currently infected with human immunodeficiency virus (HIV), where at least 50% are~     African American and at least 25% are female, either having received antiretroviral drugs~     before or not.~   "
213534|NCT00764933|"~     The purpose of this study is to test whether a structured information program at the~     beginning of the ICU-stay is effective to reduce ICU related anxiety and discomfort.~   "
213535|NCT00764920|"~     The purpose of this research is to develop non-invasive imaging modalities for assessment of~     skin. This is a pilot study which will use multiple imaging modalities to collect information~     on normal and lesional skin. The researchers understand that the purpose of this study is not~     to evaluate any particular treatment and an investigation of a new therapeutic intervention~     would require an additional protocol. Skin conditions to be studied include vascular lesions,~     pigmentary disorders, inflammatory conditions and neoplasms.~   "
213536|NCT00764907|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. A donor stem cell transplant may~     replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Giving combination chemotherapy before the transplant helps stop~     the growth of cancer cells and stop the patient's immune system from rejecting the donor's~     stem cells. It is not yet known which combination chemotherapy regimen is more effective in~     treating young patients with acute lymphoblastic leukemia.~      PURPOSE: This randomized phase III trial is studying different risk-adjusted combination~     chemotherapy regimens in treating young patients with acute lymphoblastic leukemia.~   "
213537|NCT00764894|"~     The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee~     System in a group of 200 patients for whom data has already been collected.~   "
213538|NCT00764881|"~     The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering~     from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no~     longer than one year will express the same level of sexual distress when taking SH T00658ID~     compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.~   "
213539|NCT00764868|"~     The primary objective of this study is to evaluate the long-term safety of LDX administered~     as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years~     of age inclusive at the time of consent).~   "
213540|NCT00764855|"~     Sleeping medication and analgesia are standard administered during anesthesia. Sleeping~     medication, Propofol (Diprivan, AstraZeneca), and analgesia, Remifentanil (GlaxoSmithKline),~     are most frequently used In the University Hospital Ghent.~      The clinical effect of administration of pharmaca can be measured in the changes of~     heartbeat, blood pressure, respiration and the changes of brain activity by registering EEG.~     These measurements are performed standard, to secure the safety of the patient.~      The heartbeat and the EEG will be measured by non invasive adhesive electrodes on the skin of~     the patient.~      The blood pressure will be measured by non invasive blood pressure cuff around the arm and~     the respiration parameters will be measured by non invasive spirometry, which are all~     standard available on a anesthesia device.~      Most of the pharmaca are administered by a fixed dosage schedule based on the patient's~     weight.~      A more individualized administration of this pharmaca could lead to a better anesthesia~     quality.~      Since considerable time, we know that a computer-controlled administration of these products~     by automatic coupling between the measured effects and the spuitpump to administer the~     product, could lead to a better administration, optimalisation of the administered dose,~     because the patients individual effect of the administration can be taken in consideration.~     This device is called the closed-loop system. The department of Anesthesia has already~     proofed the utility of the device for automatic administration of Propofol and opiates in~     small specific patient groups.~   "
213541|NCT00764842|"~     The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip~     stem in a group of no more than 200 patients from whom data has already been collected.~   "
213542|NCT00764829|"~     We are interested in patient-specific factors that may affect the balance of recipient cells~     and donor cells in patients who receive stem cell transplants. We will look at the way the~     patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these~     two drugs affect the patient's body.~   "
213543|NCT00764816|"~     Phosphorus is a substance in the blood that comes from food and is normally cleared from the~     body by the kidneys. In patients with kidney disease, excess phosphorus may build up in the~     body as you eat. This leads to problems with bones and blood vessels over time. In this~     study, we will compare the blood and urine before and after eating one week of a diet with a~     protein from plants (soy and grains) and before and after another one week of diet with~     protein from animals (meat and dairy products). The amount of phosphorus that the kidney puts~     out in the urine, and the changes in blood hormones in response to the diet will be measured~     at the beginning and end of each week on the two diets.~   "
213544|NCT00764803|"~     The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™~     system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data~     collection is already under way.~   "
213545|NCT00764790|"~     The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline~     Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine)~     in children, 6 to 35 months of age.~   "
213546|NCT00764777|"~     The BRAVISSIMO trial wants to investigate in a controlled setting, the long-term (up to 24~     months) outcome of the self-expanding nitinol Absolute Pro (Abbott Vascular) and the~     balloon-expandable Omnilink Elite (Abbott Vascular) stent in TASC A&B and TASC C&D iliac~     lesions. A separate analysis of both patient populations will be performed and listed.~   "
213547|NCT00764764|"~     The purpose of this pilot study is to conduct research to determine the most effective~     physical therapy treatment for a condition called shoulder impingement. This condition occurs~     when tissue in the shoulder is caught between the humerus (arm bone) and the scapula~     (shoulder blade). This causes pain when one tries to reach overhead or behind the back.~      Two treatment methods will be used in the study. The first method uses the traditional~     treatments of hands-on shoulder stretching, shoulder exercise, posture, and education. The~     second method will use the traditional methods of shoulder treatment in addition to treatment~     of the cervical spine.~      It is hypothesized that a group of patients between 40 and 70 years of age with signs and~     symptoms of shoulder impingement who receive physical therapy to the cervical spine and~     shoulder will report a higher level of functioning, will report less pain, and will gain more~     range of motion than a group of patients receiving physical therapy solely to the shoulder.~   "
213548|NCT00764751|"~     This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream~     versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied~     twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. All~     subjects will apply LEO 19123 cream to psoriasis lesions on the left or right side of the~     body and either Dovonex® cream or cream vehicle to lesions on the other side.~   "
213549|NCT00764738|"~     Visual outcomes using monthly ranibizumab therapy are well established in clinical trials,~     but the best way to assess when and how to treat patients with PRN therapy has not been~     proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with~     ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other~     assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors~     of when patients should be retreated. This study will assess 2 groups (monthly and PRN~     therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For~     the PRN group retreatment will be based on OCT criteria. We will investigate if~     microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.~   "
213550|NCT00764725|"~     The Swefot trial was designed to compare two treatment strategies for patients with early~     rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of~     traditional antirheumatic medications (DMARDs), versus a combination including a newer~     biological anti-TNF medication. In order to make this trial consistent with current~     practices in rheumatology, all patients were first given the most commonly used antirheumatic~     medication, methotrexate (MTX). After 3-4 months those patients who had not responded~     adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus~     hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed~     patients who could not tolerate one of the added medications to switch in treatment - but~     keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be~     replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial~     was the percentage of patients who, after one year of treatment, achieved a good response~     as defined by Eular.~   "
213552|NCT00764699|"~     Patients with Crohn disease often have poor weight gain and short stature, yet the etiology~     of the poor growth is not well defined. Studies in chronically ill patients who do not have~     Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate~     IGF-1 generation. Previous studies of GH use in Crohn patients have demonstrated improvement~     in linear growth, weight and bone mineralization. However, GH can cause glucose intolerance~     in chronically ill children, particularly those who require treatment with corticosteroids.~     Recently the FDA has approved recombinant IGF-1 (rhIGF) for treatment of IGF-1 deficient~     short stature. This medication has not been studied in Crohn disease. The purpose of this~     study is to test the hypothesis that poor growth in Crohn disease is associated abnormal~     IGF-1 generation which leads to poor linear growth, decreased weight and osteoporosis and~     that replacement of IGF-1 with rhIGF will correct growth and improve bone density. To test~     our hypothesis we will recruit 20 patients with Crohn disease from our pediatric~     gastroenterology practice. Each will have been previously diagnosed with Crohn disease for a~     minimum of one year and will be studied at baseline and six month intervals for one year~     while on treatment with Increlex.~   "
213553|NCT00764686|"~     Ankylosing Spondylitis(AS) is a chronic, inflammatory, rheumatic disease (Khan, 2002). AS is~     associated with increased work disability and use of healthcare resources (Ward et al, 2008).~     Evidence suggests that group exercise is the most effective form of physiotherapy management~     for individuals with Ankylosing Spondylitis (Dagfinrud et al, 2008). To date, no research has~     been published in relation to short, intensive group exercise programmes.~      This study aims to investigate the effects of a five day exercise and education programme for~     individuals with Ankylosing Spondylitis. Effects of the programme on disease activity,~     function and spinal mobility will be measured using using validated quantitative measures;~     the overall value of the programme for patients will be explored by means of semi-structured~     interviews.~   "
213554|NCT00764673|"~     The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™~     system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic~     implant in the knee. Each knee will be designated as a separate subject and followed for a~     period of 2 years.~   "
213555|NCT00764660|"~     The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on~     heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol~     dependence.~   "
213556|NCT00764647|"~     The purpose of this evaluation was to determine the effectiveness of an educational program~     designed to assist family caregivers to learn the knowledge and skills to take better care of~     their frail elder relatives and themselves.~   "
213557|NCT00764634|"~     This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter~     investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different~     three-dose dosing schedules.~   "
213558|NCT00764621|"~     Patients with a history of colorectal cancer and known or suspected liver metastases who are~     scheduled for contrast-enhanced tomographic imaging will be included in this study. After~     randomization to either Primovist-enhanced MRI, extracellular contrast media (ECCM)-enhanced~     MRI or contrast-enhanced (CE)-CT outcomes and resource needs of the diagnostic work-up and~     treatment will be evaluated for each of the three imaging modalities. Main objectives of the~     study are to assess the proportion of patients for whom further imaging is required to come~     to a therapy decision and to evaluate the proportion of patients with intraoperatively~     modified surgical plans after Primovist-enhanced MRI as compared to ECCM-enhanced MRI and~     CE-CT.~   "
213559|NCT00764608|"~     Numerous organisms live on and in healthy human skin. This study seeks to survey the~     diversity of this complex ecosystem by collecting samples from approximately 1000 individuals~     in order to determine the type of organisms living on their skin.~   "
213560|NCT00764595|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how~     well it works in treating patients with liver metastasis from a gastrointestinal stromal~     tumor.~   "
213561|NCT00764582|"~     Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients~     undergoing penetrating keratoplasty (PK)~   "
213562|NCT00764569|"~     The overall objective of this work is to identify changes in the optical properties of oral~     tissues to develop a non-invasive tool for the detection, diagnosis and screening of oral~     pathology so that treatment can be provided at the earliest possible time.~   "
213563|NCT00764556|"~     Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital~     with exacerbations of their lung disease. A combination of the acute illness and treatment~     with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than~     those with normal blood sugar. The aim of this study is to develop a safe and effective~     protocol for tight control of blood glucose with insulin on acute medical wards outside the~     intensive care environment. This will allow us to perform a formal trial to determine whether~     blood glucose control with insulin reduces death and complications from COPD exacerbations.~   "
213564|NCT00764543|"~     Children with unilateral congenital urine flow impairment, who require surgery, have abnormal~     24-hour ambulatory blood pressure measurements.~   "
213565|NCT00764530|"~     Evaluate the safety and efficacy of the CeramTec Acetabular Alumina Insert and CeramTec~     Alumina head when used with the Foundation Porous Coated Acetabular Shell and an Encore hip~     stem.~   "
213566|NCT00764517|"~     This phase II trial studies how well giving vorinostat, cladribine, and rituximab together~     works in treating patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia~     (CLL), or B cell non-Hodgkin's lymphoma (NHL) that has returned after a period of~     improvement. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may~     block cancer growth in different ways by targeting certain cells. Giving vorinostat together~     with cladribine and rituximab may kill more cancer cells.~   "
213567|NCT00764504|"~     The objective of this clinical study is to evaluate the safety and efficacy of the Encore~     Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to~     clinical results published in literature for rotator cuff arthropathy and salvage procedures.~   "
213568|NCT00764478|"~     This trial will study the efficacy and safety of a fixed dose of asenapine in participants~     diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly~     assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily [BID]) or~     placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each~     participant at various times to assess the safety and effectiveness of the study treatment.~     The primary hypothesis is that there is at least one dose of asenapine that is superior to~     placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating~     Scale [YMRS]) at Day 21 of the trial.~   "
213569|NCT00764465|"~     To date, no study has investigated whether there is a drug interaction between the protease~     inhibitor fosamprenavir and the entry inhibitor maraviroc. COL112237 is a randomized,~     open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir~     (APV) and maraviroc (MVC) pharmacokinetics in 48 healthy, HIV-negative adults after~     administration of a 7-day regimen of MVC 300mg BID alone and after 14-day regimens of~     unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/RTV 100mg BID, or FPV~     1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent MVC 300mg BID. Blood~     samples for drug concentration measurement will be collected over 12 hours at the end of each~     dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with~     differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and~     lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C,~     will be repeated at follow-up post-study. Adverse events and adherence (by pill count and~     medication diary) will be assessed by the investigator/study personnel at the end of each~     dosing period.~   "
213570|NCT00764439|"~     Pilot study of a new nicotine replacement therapy for smoking cessation.~   "
213571|NCT00764426|"~     Effect of moderate alcohol consumption in form of red wine, beer and ethanol solution and~     corresponding de-alcoholised beverages on immune measures.~        -  In healthy middle aged men and women~        -  In a randomized controlled cross-over trial~        -  Two intervention periods over 3 weeks~   "
213572|NCT00764413|"~     The Immunological system is showing a diurnal rhythmicity. The Mediators that enhances~     inflammation are at highest level during the night. At the same time the endogenous~     production of cortisol is at its lowest. We want to study if there is a better effect of~     treatment with Methylprednisolone for acute MS-attacks if given at nighttime. The effect will~     be measured in relation to neurological deficits and function with Kurtzkes Expanded~     Disability Status Score (EDSS) and Multiple Sclerosis Functional Composite (MSFC). We want to~     see if the mean improvement in EDSS is greater in the group receiving treatment at night~     opposed to the group that get treatment during the daytime.~   "
213573|NCT00764400|"~     In this study the investigators are examining the effectiveness of two different speech~     therapy protocols for word retrieval impairments experienced by individuals with~     stroke-induced aphasia. One treatment involves errorless naming treatment and the other~     employs verbal plus gestural facilitation of word retrieval. Participants will receive one of~     the two treatments over several months. Before and after treatment the investigators will~     administer several tests and conversational samples to examine changes associated with the~     treatments. The investigators hypothesize that, whereas both treatments will lead to~     improvements in words rehearsed in therapy, communication outcomes in conversation will be~     broader for the verbal plus gestural protocol.~   "
213574|NCT00764387|"~     Study to compare of two contrast agents in imaging brain lesions.~   "
213575|NCT00764374|"~     To examine the safety and efficacy of Z-338 (YM443) after long-term administration in~     patients with functional dyspepsia, and also to examine the pattern of long-term~     administration.~   "
213576|NCT00764361|"~     This study is a double-blind, one center, two-arm study with a two (2) week Run-In,~     evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied~     to diabetic ulcers in concert with professionally administered Standard of Care (SOC)~     procedures as described by Standard Operating Procedure(s) of the Department of Veterans~     Administration Hospitals. During the run-in period patients with infected wounds will receive~     oral antibiotic and not be included in the topical portion of the study until the infection~     is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all~     patients to receive SOC treatment for diabetic ulcers, patients would have either the~     investigational material or the placebo hydrogel applied as a part of their wound care. Each~     patient would receive 1.5 gm packets of either the test article or the placebo hydrogel for a~     once-daily home treatment accompanied by a dressing change.~   "
213577|NCT00764348|"~     Patients who present to a wound care center for management of their wounds will be evaluated~     clinically to establish if their wounds are chronic or acute. These patients will undergo~     standard of care management of their wounds. If debridement is indicated for the patient, the~     patient will be asked to participate in a study. Once the standard of care debridement is~     complete, the material debrided from the wound, instead of being discarded into a biohazard~     bag, will be prepared for shipment. The samples will then be shipped to the Center for~     Biofilm Engineering where microscopic evaluation will be conducted on the material.~     Conclusion will be made from that analysis.~   "
213578|NCT00764335|"~     The purpose of the present study was to determine whether unilaterally operated total hip~     arthroplasty (THA) patients were superior to bilaterally operated THA patients with respect~     to aerobic endurance capacity, muscle strength and gait patterns 3-5 years after surgery, and~     to what extent medial femoral head offset (FO) influenced hip abductor strength.~   "
213579|NCT00764322|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about differences in DNA and predict how well patients will respond to~     treatment and plan better treatment.~      PURPOSE: This clinical trial is studying blood samples from women with breast cancer or~     ductal carcinoma in situ who are receiving tamoxifen.~   "
213580|NCT00764309|"~     The purpose of this study was to evaluate the safety of Dasatininb in the treatment of~     scleroderma pulmonary interstitial fibrosis.~   "
213581|NCT00764296|"~     The Specific Aim of examining wounds microscopically is to attempt to demonstrate the~     presence of biofilm in chronic wounds and to understand these populations on a cellular~     level.~   "
219214|NCT00689624|"~     This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young~     patients with good performance status with unresectable metastatic colorectal cancer.~   "
213582|NCT00764283|"~     Three types of dressing will be compared to prevent postoperative epidural catheter~     migration. Patients will be randomised to have a Tegaderm dressing, an Epi-fix dressing or a~     Lockit-Plus dressing to secure the epidural catheter for postoperative analgesia. The length~     of the epidural catheter visible at the patient's skin surface will be recorded after~     insertion and every day until removal. The integrity of the dressing and problems with~     analgesia will also be recorded.~   "
213583|NCT00764270|"~     The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to~     reduce risk factors in people with documented heart disease and increased levels of~     inflammation.~   "
213584|NCT00764257|"~     The purpose of this study was to assess PREVELLE Shape (CX002), with respect to safety and~     efficacy for one year following treatment, for correction of facial nasolabial folds and when~     applied as an intradermal implant for lip augmentation.~   "
213585|NCT00764244|"~     Macular edema is the main cause of vision loss in diabetic patients. Its treatment is mainly~     based on laser photocoagulation, but has limited results. Alternative treatment are under~     investigation, such as vitrectomy and intravitreal injections of triamcinolone .The aim of~     VITRILASE is to compare the efficacy of these two treatments to laser photocoagulation for~     diabetic macular edema.~   "
213586|NCT00764231|"~     Fatigue is the most common and disabling symptom in acute myeloid leukaemia (AML). Studies in~     other cancer patients with fatigue have shown that exercise improves both fatigue and quality~     of life (QOL), but there are no such studies in AML. The investigators want to conduct a~     pilot study of a home-based exercise program to see if this type of exercise program is~     feasible for AML patients, reduces fatigue, and improves QOL. What the investigators learn~     from this study will be essential to designing a larger, definitive randomized trial of~     exercise in patients with AML.~   "
213587|NCT00764218|"~     Patients with obstructive sleep apnea syndrome have permanent variations of their hemodynamic~     parameters during the night : heart rate, arterial blood pressure, cardiac output. This is~     due to the repetition of respiratory events (obstructive apnea and hypopnea) leading to~     frequent micro-arousals. These disorders have several consequences : hypertension,~     NO-dependent vasodilatation impairment, baroreceptor reflex impairment, insulin resistance~     and other cardiovascular impairments.~   "
213588|NCT00764205|"~     This study randomizes patients seen by Redmond Medic One into a control arm and a study arm~     when they present with acute coronary syndrome and have non-contributory ECG's~     (i.e.non-STEMI). The control group is treated normally and delivered to the receiving~     hospital. The study group is treated normally as well, however troponin measurements are made~     using an i-STAT blood analyzer prior to hospital arrival. The results are presented to the~     receiving physician. Door-to-reperfusion time is monitored for both groups.~   "
213589|NCT00764192|"~     An impairment of nitric oxide (NO) bioavailability is associated with endothelial dysfunction~     and may contribute to the excessive incidence of cardiovascular complication in chronic~     haemodialysis (HD) patients. It is not known whether cell-free hemoglobin limits nitric oxide~     bioavailability during HD.~   "
213590|NCT00764179|"~     Neonates with intra-uterine growth delay represent more than 2% of the 800 000 annual births~     in France. Studies have shown that milks enriched with protein allow to accelerate newborns~     growth. According to some papers, growth acceleration would have a favourable effect on~     psycho-motor development at age of 2 or 3. However, for other authors, this would not lead to~     any benefit and even an early hyperproteinic feeding would have bad long term consequences~     such as appearance of several diseases in the future adult (overweight, diabetes, arterial~     hypertension, renal function alteration).The main objective of this clinical trial is to~     check that an hyperproteinic feeding does not lead to any benefit on psycho-motor development~     at age of 2, compared with a milk containing same level of protein than milk proposed to~     newborns of normal weight. The secondary objectives of our clinical trial are to compare the~     effects of these two types of milk on renal function, arterial blood pressure, body~     composition, corpulence, food preferences, insulin resistance and intestinal integrity at age~     of 2. A sub study will also be realized to analyse the proteic turn over . This sub-study~     will be undertaken only with neonates of Nantes Hospital.~   "
213591|NCT00764166|"~     The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS)~     of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or~     without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).~      The study was powered at 80% to detect a 25% improvement in biochemical PFS for a total~     sample size estimated at 252 patients, with a two-sided type I error rate of 5%~     (non-parametric methods.~   "
213592|NCT00764153|"~     An estimated 1.6 million patients sustain a hip fracture every year, about half of these are~     intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for~     any patient, and the risk of disability, increased dependence and death is substantial. The~     main treatment options for displaced femoral neck fractures are internal fixation and~     arthroplasty. It is established that there are more complications and reoperations after~     internal fixation, and better short term clinical results with arthroplasty, but knowledge~     about long term results is lacking.~   "
213593|NCT00764140|"~     Malignant cells frequently produce many tumor growth factors to autocidal or endocrinal~     proliferate growth, metastasis,or angiogenesis about tumor cells. By studying tumor growth~     factors in hepatocellular carcinoma, one may know the tumor behavior, its relationship with~     clinical manifestation or invasion, and could be used as diagnostic or prognostic tools.This~     study aims to study the relationship between tumor growth factors in HCC ant its clinical~     relevance.~   "
213594|NCT00764127|"~     The purpose of the study is to develop methods to evaluate the eating behavior of~     adolescents, including overweight, normal weight, and candidates for adolescent bariatric~     surgery.~   "
213595|NCT00764114|"~     Duration of antimicrobial therapy for spondylodiscitis is not standardized; it could vary~     from 6 weeks to several months depending on the medical habits. The study hypothesis is that~     a 6 weeks antimicrobial therapy is not inferior to a 12 weeks.~      We run a prospective multi-centric, non inferiority open label trial, randomised in two~     parallel groups.~      The main objective is to compare the efficacy of two durations of antibiotherapy, 6 weeks~     versus 12 weeks, on the rate of cure in this indication.~      The study concerns 400 patients more than 18 years, 70 centres in France are involved.~      The duration of the study is 4 years.~   "
213597|NCT00764088|"~     To demonstrate the effectiveness or ineffectiveness of novel treating agents or agents used~     for compassionate rescue, subjects and their wounds will be analyzed retrospectively and~     their non-identifiable information will be compiled in the form of case studies. Subjects who~     demonstrated characteristics of interest (e.g. healing) as determined by the PI will be~     chosen for case studies.~   "
213598|NCT00764075|"~     In this open, prospective, randomized, parallel group, German-American, two-center, Phase I~     study the standard-approach CRT-implantation will be compared to a guided CRT-implantation~     after determining the site of latest contraction and placement of the electrode as close as~     possible to this site, using a 5-step-scheme of imaging methods determining the site of~     latest contraction prior to implantation.~   "
213599|NCT00764062|"~     Antibiotic resistance is a worldwide problem closely linked to antibiotic consumption. To~     limit the risk to select resistant bacteria, the rules of prescription are to use high doses~     and short durations of treatment. The purpose of this study was to evaluate the interest to~     reduce amoxicillin treatment from 7 days to 3 days, in cases of odontogenic infection~     requiring the extraction of the tooth associated with amoxicillin monotherapy. The 3-day~     treatment will be compared to the classical 7-day treatment for clinical efficacy (pain,~     wound healing) and impact on the susceptibility of oral streptococci to amoxicillin.~   "
213600|NCT00764049|"~     The aim of this study is to determine whether a simplified device of albumin dialysis also~     has beneficial effects.~   "
213601|NCT00764036|"~     The purpose of this study is to evaluation the tolerability of an add-on therapy with~     artesunate with a duration of 4 weeks in patients with advanced breast cancer.~   "
213602|NCT00764023|"~     The intent of this protocol is to salvage human-related material that is normally destined~     for destruction, so it can be used in infection-related scientific studies. This clinical~     material can be studied in order to better understand the molecular, cellular, or ecological~     components of the infected or potentially infected tissue or device.~   "
213603|NCT00764010|"~     The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very~     long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of~     atherosclerosis in a high risk population. A total of 563 elderly men were included and~     randomized to receive usual care and VLC n-3 placebo capsules (control group), dietary advice~     and VLC n-3 placebo capsules, usual care and VLC n-3 capsules, and finally both VLC n-3~     capsules and dietary advice.~      The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media~     thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.~   "
213604|NCT00763997|"~     Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of~     traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators~     conducted the study in comparing patients undergoing traumatologic, visceral or plastic~     surgical procedures. The investigators randomized them to four groups receiving common~     analgetic doses of either dipyrone, acetaminophen (paracetamol) or valdecoxib/parecoxib. The~     investigators took blood samples before initiation of the study drug, 1h, 4hs and 24hs after~     first intake. The investigators compared the aggregation via aggregometry of platelet rich~     plasma.~   "
213605|NCT00763984|"~     The primary goal of this project is to determine the efficacy of an antenatal Bladder Health~     class to prevent UI in a diverse sample of African American, Caucasian, and Hispanic~     childbearing women. The determination of efficacy will be made at 12-months post index birth,~     a time point that is a traditional benchmark of recovery from childbirth, using UI~     incidence/severity as the primary outcome.~   "
213606|NCT00763971|"~     The main aim of this study is to see if giving LDX to children and adolescents aged 6-17~     years with ADHD decreases symptoms of ADHD.~   "
213607|NCT00763958|"~     This study is a feasibility and acceptability study assessing whether providing buprenorphine~     for women under criminal justice supervision leaving a controlled environment and returning~     to the community would prevent opioid relapse and reduce HIV risk behaviors.~   "
213608|NCT00763945|"~     The Aachener Digitale Myokardinfarkt Register (ADMIRE) is a prospektive registry study which~     was designed in order to obtain data of patients with acute coronary syndrome and herewith~     control and optimize guideline conform therapy of these patients.~   "
213609|NCT00763932|"~     This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in~     patients with infantile-onset Pompe disease who were previously treated with rhGAA derived~     from the Synpac cell line~   "
213610|NCT00763919|"~     In this study, patients with bipolar disorder who do not take their medications as prescribed~     will receive specialized education and therapy treatment to determine whether the specialized~     treatment is effective in helping patients to take their medications consistently.~   "
213611|NCT00763906|"~     The weaning rate of vasopressors drugs is usually chosen empirically by the clinician in~     critically patients. The investigators applied fuzzy logic principles to modify intravenous~     norepinephrine infusion rates during norepinephrine infusion in septic patients in order to~     reduce the duration of shock. The investigators goal was to reduce the duration of poorly~     controlled hemodynamic status.~   "
213612|NCT00763893|"~     The purpose of this study is to evaluate if losartan limits aortic dilatation in patients~     with Marfan syndrome.~   "
213613|NCT00763880|"~     The purpose of our study is to determine if the use of a hematoma block together with~     intravenous sedation and analgesia is an effective means of managing forearm fractures in the~     Emergency Department. To determine this, we have designed a randomized, double-blind, placebo~     controlled trial of hematoma block versus saline for the manipulation of forearm fractures~     under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the~     use of a hematoma block together with conscious sedation will allow for improved pain~     control. Second, the use of a hematoma block together with conscious sedation will allow us~     to use less sedation, therefore promoting faster recovery from sedation and more efficient~     patient turnover in the Emergency Department.~   "
213614|NCT00763867|"~     Diastolic heart failure (DHF), which affects older individuals and women at a~     disproportionate rate, is a condition that can lead to shortness of breath and fluid build-up~     in the lungs. This study will evaluate the effectiveness of the medication sildenafil at~     improving exercise ability and health outcomes in people with DHF.~   "
213615|NCT00763841|"~     Transcranial magnetic stimulation (TMS) involves the use of magnetic fields to non-invasively~     stimulate the brain. Studies overseas have suggested this may be an effective and safe~     treatment for auditory hallucinations in patients with schizophrenia. This is a~     sham-controlled, double-blind trial of TMS stimulation for the treatment of auditory~     hallucinations in patients with schizophrenia.~   "
213616|NCT00763828|"~     The hypothesis of this study is that consciously sedated patients suffering from ST-elevation~     myocardial infarction can be rapidly and safely cooled to a state of therapeutic hypothermia~     (32 to 34 degrees C) using the LRS ThermoSuit System prior to percutaneous coronary~     intervention.~   "
213617|NCT00763815|"~     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in~     comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over~     a period of 24 weeks of treatment, followed by an extension.~      The primary objective is to assess the effects of lixisenatide when added to pioglitazone on~     glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at~     Week 24.~      Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on~     the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to~     6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic~     model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to~     assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody~     development.~   "
213618|NCT00763802|"~     This project aims to validate a predictive model of diabetic retinopathy progression to~     clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The~     Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and~     LDL levels, established on a set of 52 diabetic patients, will be tested on a population of~     400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at~     6-month interval (V0 and V6) to classify each patient into one of the 3 previously~     established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of~     end-points, achieved by the patients, are expected to validate our predictive model.~   "
213619|NCT00763789|"~     The purpose of this study is to compare a new method: the combination of conscious sedation~     with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional~     general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in~     the operation room, the time to full mobilisation postoperatively and the time to complete~     recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.~   "
213620|NCT00763776|"~     To identify the most efficient parenchyma transection technique for cirrhotic liver resection~     between the clamp crushing technique and the ultrasonic dissector.~      Primary endpoint is intra-operative blood loss during liver transection (ml). Expected~     results and implications: If one of the technique is better than the other, surgical teams~     could prefer it to minimize the morbidity of liver resection in cirrhotic patients.~   "
213621|NCT00763763|"~     Patients not previously exposed to imatinib and with resistant or refractory Ph+ ALL,~     lymphoid blast crisis chronic myelogenous leukaemia (LBC CML) or with de novo Ph+ ALL and~     aged over 55y were eligible in the study. The DIV regimen consisted in one IV injection of~     vincristine 2 mg combined with 2 days of dexamethasone 40 mg PO repeated weekly for 4 weeks~     as induction and then monthly for 4 months as consolidation. Imatinib was administered at 800~     mg per day during the induction period and at 600 mg/d continuously during consolidation.~     Patients in CR not eligible for HSCT were allocated to maintenance therapy consisting in~     weekly SC injection of Pegasys 45 µg and continuous administration of imatinib 400 mg per day~     for 2 years.~   "
213622|NCT00763750|"~     The purpose of this study is to determine the antitumor activity of PPX in combination with~     temozolomide and radiation for patients with newly diagnosed brain tumors.~   "
213623|NCT00763737|"~     Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and~     remains associated with an 30 % chance of perinatal death and morbidity mainly because of~     pulmonary hypoplasia and pulmonary hypertension. In addition, in the survivors there is a~     high rate of morbidity with evidence of bronchopulmonary dysplasia in more than 70% of cases.~     The risk for these can be predicted prenatally by the ultrasonographic measurement of the~     observed/expected lung area to head circumference ratio (O/E LHR) which is a measure of~     pulmonary hypoplasia. Also position of the liver is predictive of outcome.~      The proposing consortium has developed a prenatal therapeutic approach, which consists of~     percutaneous fetoscopic endoluminal tracheal occlusion (FETO) with subsequent removal of the~     balloon . Both procedures are performed percutaneously, there is now experience with more~     than 150 cases and it has been shown to be safe for the mother. We have witnessed an~     improvement of survival in fetuses with a predicted chance of survival of less than 30%~     (referred to as fetuses with severe pulmonary hypoplasia; O/E LHR <25% and liver herniation)~     to 55% on average. Also there is an apparent reduction in morbidity with the rate of~     bronchopulmonary dysplasia decreasing from the estimated rate of more than 70% to less than~     40% in the same severity group .~      Further we have shown that results of FETO are predicted by LHR measurement prior to the~     procedure , so that better results can be expected in fetuses with larger lung size .~     Therefore we now aim to offer FETO to fetuses with moderate CDH (=O/E LHR 25-34.9%,~     irrespective of the liver position as well as O/E LHR 35-44.9% with intrathoracic herniation~     of the liver). When managed expectantly the estimated rate of postnatal survival is 60% or~     lower and the rate of broncho-pulmonary dysplasia in survivors is 33% or higher.~      This trial will test whether temporary fetoscopic tracheal occlusion rather than expectant~     management during pregnancy, both followed by standardized postnatal management, decreases~     the occurrence of bronchopulmonary dysplasia or increases survival. The balloon will be~     placed between 30 and 31+6 weeks, and will be removed between 34 and 34+6 weeks.~   "
213624|NCT00763724|"~     The primary objective of the study is to estimate the incidence of suicide attempts resulting~     in a medical encounter or hospitalization in seven propensity matched cohorts of subjects:~     patients treated with duloxetine for depression, patients treated with one of three other~     antidepressants or antidepressant classes (venlafaxine, SSRIs, or TCAs) for depression,~     patients treated with multiple antidepressants for depression (either concurrently or~     consecutively), depressed patients with no pharmacologic treatment, and a non-depressed~     general population sample.~   "
213625|NCT00763711|"~     The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly~     guiding an injection needle into the appropriate tissue plane during an injectable bulking~     agent procedure in women using a FDA approved injectable bulking agent. The injectable~     bulking agent will be Durasphere EXP.~   "
213626|NCT00763698|"~     This is a prospective, multi-center non-randomized clinical study to evaluate the safety and~     efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient~     population. The study will be conducted at a maximum of 20 investigational centers located in~     the United States and a total of 68 patients will be enrolled.~   "
213627|NCT00763685|"~     Primary Hypothesis:~      1. The analgesic effect of etoricoxib 120 mg administered 1 hour preoperatively is greater~     than that of placebo in the treatment of postoperative pain.~   "
213628|NCT00763672|"~     The purpose of this study is to determine whether close monitoring of patients with a high~     sFlt1 plasma level between 25 and 28 weeks of gestation (i.e. at high risk of subsequent~     preeclampsia) improves maternal and fetal outcomes. The investigator hypothesize that 1/~     early screening for preeclampsia by plasmatic sFlt1 will reduce maternal and fetal mortality~     and morbidity and 2/ a simple urinary PlGF screening will be effective.~   "
213629|NCT00763659|"~     The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the~     supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the~     optical density (OD) of macular pigment in patients with non- exudative age related~     maculopathy.~      Furthermore, it is to be examined whether changes of the optical density are different~     dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD~     patients are studied. The measurement of optical density of macular pigment uses the 1-~     wavelength reflection method recording reflection images at 460 nm by a fundus camera. The~     patients are investigated at baseline and are followed up over one year in four more visits.~     In addition to the OD- measurement each examination includes standardized visual acuity test~     (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and~     autofluorescence) and a blood sample.~   "
213630|NCT00763646|"~     The primary purpose of the study is to determine the impact of chemotherapy on the ability of~     your surgeon to completely remove the cancer as well as the impact on your survival.~     Furthermore the investigators will be assessing the side effects of this chemotherapy~     strategy. Finally the investigators will determine the ability of specialized imaging~     technology (PET scan) to document and predict the response of the tumor to this chemotherapy.~      Standard therapy for patients with your condition usually consists of surgery (removal of the~     tumor) followed by combination chemotherapy and radiotherapy. More recently, standard options~     available to patients with cancer of the stomach or lower esophagus have been expanded to~     include chemotherapy without radiotherapy prior to and following surgery. While it is~     believed that chemotherapy prior to surgery is a good option for patients with stomach, it is~     not known what is the optimal chemotherapy regimen to offer patients prior to surgery to~     improve the likelihood of cure while limiting side-effects to patients.~   "
213631|NCT00763633|"~     The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is~     effective in nausea and vomiting of pregnancy.~   "
213632|NCT00763620|"~     The aim of this study is to develop a safe and effective technique to take sample for lower~     respiratory tract cultures easy to perform in conditions of acute respiratory failure and~     spontaneous ventilation for patients admitted in intensive care unit for acute infectious~     pneumonia and non intubated. The investigators perform sample collection with a mini~     bronchoalveolar lavage catheter introduced by nasotracheal way through a suction catheter.~     The purpose of the study is to assess the microbiological diagnostic capacity of this new~     technique.~   "
213633|NCT00763607|"~     Aim of the study is to evaluated the role of IGF1R and p95HER2 on prognosis in radically~     resected non small cell lung cancer patients~      The primary objective is to correlate the expression of IGF1R and p95HER2 with survival.~   "
213634|NCT00763594|"~     The study investigates the relative efficacy of Interpersonal Psychotherapy and Brief~     Relational Therapy for Major Depressive Disorder. The primary hypothesis is that there will~     be no mean difference in efficacy between treatments, but that Brief Relational Therapy will~     be more efficacious for more self-critical patients and Interpersonal Psychotherapy will be~     more efficacious for less self-critical patients.~   "
213635|NCT00763581|"~     This study will attempt to increase understanding of why bipolar disorder patients do or do~     not take their medications by conducting in-depth interviews with them.~   "
213636|NCT00763568|"~     The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed~     by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin~     (standard of care) for 48 weeks.~   "
213637|NCT00763555|"~     This is a multicenter, randomized, vehicle-controlled, double-blind parallel group study to~     evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in~     subjects with plaque-type psoriasis.~   "
213638|NCT00763542|"~     This study is a randomized controlled trial comparing two treatments for patients with~     comorbid substance use disorder (SUD) and post-traumatic stress disorder (PTSD) conducted~     within two different routine clinical settings for the treatment of SUD, namely (a) a~     day-care and inpatient setting and (b) an outpatient setting. Participants will be randomly~     assigned to either (1) a combination of cognitive-behavioral treatment (CBT) for SUD and~     trauma-focused structured writing therapy, or (2) CBT for SUD alone. Randomization will take~     place separately for each setting. It is expected that the combined treatment is~     significantly more effective in reducing symptoms of SUD as well as PTSD than CBT for SUD~     alone. Outcome measures will be assessed at pre-treatment, post-treatment as well as 3~     months, 6 months and 12 months follow-up.~   "
213639|NCT00763529|"~     This is an open-label, randomized, parallel-group clinical study. The primary objective is to~     assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs~     fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the~     management of Indian patients with localized psoriasis.~   "
213640|NCT00763516|"~     The purpose of this study is to find out what effects, good and/or bad, proton radiation~     combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will~     look at the side effects from the treatment and the quality of your life in relation to pain.~     It will also look at how the tumor responds to the combination of treatment with radiation,~     chemotherapy and surgery.~   "
213641|NCT00763503|"~     This is a multicenter, open-label study to assess systemic plasma levels of calcitriol,~     calcium homeostasis and safety in adults with plaque-type psoriasis under conditions of~     maximized use of CD 2027 3µg/g oily spray twice daily (6 g daily), applied to 20% of BSA for~     3 weeks.~      There are a total of six visits: Pre-treatment period (Day -15, Day -8 and Day -1) and~     Treatment period (Day 1/ Baseline, Day 15 and Day 22).~   "
213686|NCT00762905|"~     To evaluate the effectiveness, safety, and utility of LiquiBand Laparoscopic™ in relation to~     a currently approved active control product (High Viscosity DermaBond). Specifically, the~     study is powered to demonstrate that LiquiBand Laparoscopic™ is not inferior to DermaBond in~     the rates of infection, dehiscence, cosmesis and apposition of the skin.~   "
213642|NCT00763490|"~     This pilot research study is to investigate the safety and effectiveness of stem cell~     transplantation to treat blood-related (hematopoietic) cancers, using stem cells collected~     from two different, umbilical cord blood donors. Subjects in this study are receiving a stem~     cell transplant because other treatments have failed or their disease is unlikely to respond~     to other treatment options.~      Blood-related cancers can be treated and sometimes cured with very high doses of chemotherapy~     and radiation therapy, given to kill the cancer cells; however, these treatments can prove~     unsuccessful and can harm normal cells in the bone marrow or a patient's disease may be~     unlikely to respond to these treatment options.~      Hematopoietic stem cells transplantation (HSCT) is a potential cure, but opportunities to~     perform HSCT are limited by donor availability. Only 20-30% of patients may have matched~     family donors. In some cases, a mismatched family donor may be suitable. For patients needing~     a transplant who do not have a suitably matched family donor, blood stem cells from matched~     unrelated donors can be used. The length of time required to identify a matched unrelated~     donor presents another obstacle for patients waiting to receive an HSCT.~      Blood stem cells are found in umbilical cord blood (UCB), which is blood left over in the~     placenta (afterbirth) after a baby is born. Usually this blood is discarded with the~     placenta, but over the past 15 years, we have learned how to collect and freeze cord blood~     cells to be used for transplants at a later time. A cord blood unit is the cord blood cells~     collected and stored from a single placenta. More than 6,500 umbilical cord blood stem cell~     transplants have been done worldwide, mostly in children with leukemia. One important factor~     affecting the success of a cord blood transplant is the cell dose (number of stem cells in~     the cord blood unit / recipient's weight). Patients who receive a high cell dose (> 2.5 x 107~     cells/kilogram) have better marrow recovery and a higher rate of survival than those who~     receive a lower cell dose.~      In an attempt to make UCB transplantation possible for bigger children, adolescents and~     adults, researchers have tried giving two cord blood units on the same day for their~     transplant, one after the other. The data from more than 150 double cord blood transplants~     in adults suggest that the double cord blood transplants may allow bone marrow recovery and~     survival in patients who do not have a single cord blood unit with enough cells for~     successful transplantation.~      This is a pilot study to research the safety and effectiveness of using two UCB units in~     adult and pediatric UCB transplantation when combined with a conditioning regimen called~     Flu/Bu4/TLI (consisting of fludarabine, busulfan and total lymphoid irradiation).~   "
213643|NCT00763477|"~     Background to ghrelin Ghrelin is a naturally occurring hormone found in the blood which~     stimulates appetite. In healthy individuals, levels of ghrelin are high before a meal and~     falls afterwards. Previous studies have shown that giving ghrelin (by injection) to thin~     patients with renal failure and cancer increases their food intake. Furthermore, addition of~     ghrelin may also reduce inflammation within the body. Cystic Fibrosis (CF) is a genetic~     disease which frequently results in recurrent lung infections (leading to progressive~     inflammatory lung damage) and low body weight. Low body weight in CF is associated with~     increased lung infections, rapidly worsening lung function and a shortened life expectancy.~      The researchers postulate that administration of extra ghrelin to CF patients with low body~     weight may increase food intake and reduce lung inflammation. If successful, this study might~     identify ghrelin as a potential therapy for CF patients to improve nutrition, decrease lung~     inflammation and thereby improve survival.~   "
213644|NCT00763464|"~     Aim of this study is the determination of a valid procedure for ischemia diagnositc in~     postmenopausal women.~   "
213645|NCT00763451|"~     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in~     comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of~     treatment, followed by an extension.~      The primary objective is to assess the effects of lixisenatide when added to metformin on~     glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two~     steps dose titration regimen at Week 24.~      Secondary objectives are to assess the effects of lixisenatide when added to metformin on~     glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a~     one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or~     less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety,~     tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.~   "
213646|NCT00763438|"~     The purpose of this study is to permit the patients with schizophrenia who received~     Sertindole during a previous randomised trial, study 99824, to continue with this treatment.~   "
213647|NCT00763425|"~     The aim of this study is to compare cold snare polypectomy and conventional polypectomy for~     the removal and retrieval of small colorectal polyps.~      Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than~     conventional polypectomy.~   "
213648|NCT00763412|"~     The purpose of this study is to provide the necessary data and experience to design a larger,~     full scale clinical trial to determine if a certain medicine (repaglinide), which increases~     the amount of insulin secreted by the pancreas, can improve the nutritional status and~     pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by~     improving blood glucose control. The investigators are also trying to determine the~     relationship between systemic inflammatory factors and glucose impairment.~   "
213649|NCT00763399|"~     The balance between immunogenic and tolerogenic activities in human immune system strongly~     depends on microflora-induced pro-and anti-inflammatory activities. Probiotics are important~     components of microflora. The interactions of the different strains of probiotics and the~     cells of immune system are largely unknown.~      There are many mechanisms by which probiotics enhance intestinal health, including~     stimulation of immunity, competition for limited nutrients, inhibition of epithelial and~     mucosal adherence, inhibition of epithelial invasion and production of antimicrobial~     substances.~      Fecal immunoglobulin A(IgA), lactoferrin and calprotectin were determined by enzyme-linked~     immunosorbent assay(ELISA) and compared in different groups. Other clinical symptoms or~     signs, including fever, vomiting, diarrhea, abdominal pain, bloating abdomen, daily intake~     and body weight were also assessed.~      The first aim of our study is to evaluate the role of probiotics and their preparation~     products on the restoration of intestinal bacterial population. The second aim of our study~     is determining the immunomodulating effects or anti-inflammatory effects of probiotics on the~     host (human being). We try to seek to gain an advanced understanding of probiotics versus~     intestinal microorganism and host interactions, as well as mucosal immune responses to~     probiotics in the intestine.~   "
213650|NCT00763386|"~     The purpose of this study is to test for significant differences in functional outcomes~     obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is~     predicted that an increase in postoperative range of motion will be experienced by patients~     treated with the NexGen LPS-Flex knee implant.~   "
213651|NCT00763373|"~     Observation of the use of intravenous antibiotics in medical clinic of Sorlandet Hospital,~     Norway. Suggestions of criteria for the switch from intravenous to oral administration of~     antibiotics. Implementation of the criteria and new registration of the use of intravenous~     antibiotics. Comparison of the amount of the iv-administration before and after the~     intervention.~   "
213652|NCT00763360|"~     The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD)~     compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the~     ability to maintain anterior chamber space, in routine cataract surgery.~   "
213655|NCT00763308|"~     Heart disease is the leading cause of death in the United States, accounting for~     approximately 700,000 deaths a year. Heart disease can take many forms, including heart~     attacks, coronary artery disease, aneurysms, high blood pressure, and strokes. However,~     people can change things in their life to reduce the risk of getting heart disease. This~     study will first create an Internet-based program to help teach people about reducing heart~     disease risk and will then test the program in a workplace setting.~   "
213656|NCT00763295|"~     HIV infection highly increases the risk of progression of latent tuberculosis (TB) to active~     disease that therapy is recommended for all PPD-positive, HIV-infected patients, regardless~     of age. Sensitivity of the PPD testing is, however, dependent on a normal T cell function.~      Therefore, an accurate and reliable method for detection of latent tuberculosis in patients~     with HIV is urgently needed.~      This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay,~     T-SPOT.TB,for detection of TB in HIV-infected individuals.~   "
213657|NCT00763282|"~     Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal~     cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and~     most persons with SCI will have at least one serious PrU during their lifetime. VA costs of~     treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in~     FY10 was just under $400 million.~   "
213658|NCT00763269|"~     Hypersensitivity~   "
213659|NCT00763256|"~     To test effectiveness of dentifrice in maintaining periodontal health.~   "
213660|NCT00763243|"~     This study is an investigation of the effect of a computer-based working memory training~     program on memory and language processing in at-risk children (e.g., those with working~     memory weaknesses) who have received cochlear implants.~   "
213661|NCT00763230|"~     Depression is a common illness with an approximate lifetime prevalence of 17 %, conferring a~     large burden of disease in the community, often due to inadequate treatment. Thus there is~     interest in the therapeutic potential of non invasive, novel forms of brain stimulation, such~     as transcranial direct current stimulation (tDCS). Two small studies have been published in~     the last two years indicating that 20 minutes of either 1 or 2mA tDCS over 5 or 10 sessions~     is safe, painless and well tolerated. The investigators' own pilot data (N=30) also suggests~     the technique has antidepressant effects and is safe (5-10 sessions of tDCS at 1 mA).~      This study will extend previous findings, testing a more definitive tDCS approach (also left~     prefrontal anodal stimulation) with a longer treatment course (15 sessions), at 2 mA (which~     has been found to be safe and more effective than 1 mA in cognitive studies), and in a larger~     sample (N=68), using a placebo-controlled design.~      It is hypothesised that active tDCS (15 sessions) will have greater efficacy than sham~     treatment (15 sessions) in reducing the severity of depressive symptoms in patients in an~     episode of major depression. A second hypothesis is that 15 sessions of tDCS will not cause~     any significant adverse effects or cause decline in neuropsychological functioning in~     comparison to a sham control.~   "
213662|NCT00763217|"~     In a previous suty, we have demonstrated that prior transient ischemic attack, treatment~     lipid-lowering drug or physical activity are associated to a better outcome of stroke. The~     aim of the study is to understand the mechanisms of this preventive neuroprotection by~     establishing link between biomarkers and preventive and neuroprotective measures.To answer to~     the question, we conduct a cohort study of stroke patients.~   "
213663|NCT00763204|"~     The purpose of this study is to investigate dose-response relationship, antipsoriatic~     efficacy and safety of different concentrations of topical formulations with AN2728 in~     subjects with psoriasis vulgaris.~   "
213664|NCT00763191|"~     The specific aim of this study is to compare ocular movements abnormalities between males~     with pre-mutation on FRM1 gene (symptomatic or asymptomatic on the motor plan and/or on the~     cognitive plan), males without the pre-mutation and males with multi-systematized atrophy, in~     order to identify the neuronal structures implicated in this pathology.~   "
213665|NCT00763178|"~     Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment~     response to pharmacological interventions has been modest for these patients. Chronic~     elevated anxiety and associated psychophysiological parameters including increased heart rate~     and alterations in skin conductance are key symptoms of chronic PTSD. Selective serotonin~     reuptake inhibitors (SRIs) are considered treatment of first choice for these patients,~     however a substantial portion of patients treated with SRIs do not respond sufficiently.~     Therefore, there is a need to establish novel and effective treatment strategies for these~     patients. Recently, duloxetine has received considerable attention since it was shown in~     multiple controlled trials to be an effective treatment for people with major depressive~     disorder (MDD), a condition which is often co-morbid with PTSD. In chronic PTSD, the~     psychophysiological responses at baseline and in response to treatment with duloxetine have~     been inadequately studied and may provide novel insight into antidepressant and anxiolytic~     mechanisms of this compound.~      Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of duloxetine in patients~     with chronic PTSD.~      Secondary Aim 2: Evaluate the effects of duloxetine on fear conditioned psychophysiological~     responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat~     interval) at baseline and after 8 weeks of naturalistic treatment in chronic PTSD patients.~   "
213666|NCT00763165|"~     To access the influence of triclosan dentifrice on the progression of periodontal disease in~     patients with coronary heart disease.~   "
213667|NCT00763152|"~     This is an observational study to collect placement and tracking data for patients who have~     the Calypso transponders implanted into the peri-prostatic tissue.~   "
213668|NCT00763139|"~     Rheumatoid arthritis (RA) is a form of arthritis that causes pain, swelling, stiffness, and~     loss of function in the joints. Over time, joint deformity, joint destruction, and loss of~     function can occur. Current treatment aims to improve symptoms, but there is no cure for the~     disease. Pioglitazone is drug that is effective in treating people with diabetes. This study~     will determine whether pioglitazone can also be used to effectively treat people with RA.~   "
213687|NCT00762892|"~     This is a pilot that will evaluate two regimens for treating HIV infected patients that~     haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial~     infarction and antiretroviral therapy used may contribute to this. We will evaluate~     virological, immunological and cardiovascular effects of two HIV treatment regimens.~   "
213669|NCT00763126|"~     It is unclear the effect of a spouse's presence on the partureint's and the spouse's stress~     level during the performance of epidural analgesia during labor.~      Couples will be randomized to two groups: one group where the spouse is present during the~     performance of epidural analgesia and the second where the spouse is not present.~      Before and after epidural anlgesia, both the spouse and parturient will be have their blood~     pressure and pulse checked. In addition, both will have their salivary amylase measured.~      Salivary amylase is an enzyme whic has been foud to correlate directly with stress levels. To~     check this enzyme, a sample of saliva is given.~   "
213670|NCT00763113|"~     Main Objectives are: Test Difference in terms of early ROM between Vanguard FB CR and~     Vanguard FB PS. Knees; Demonstrate the comparable ROM of high flex PS to CR.~   "
213671|NCT00763100|"~     There are three main objectives, centering on those patients targeted for surveillance~     imaging. The first objective is to compare image quality and specificity of breast~     tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second~     objective is to compare image quality and ability to determine post-surgical and~     post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population~     having undergone conservation therapy (lumpectomy with or without radiation. The final~     objective is to compare image quality and the ability to determine chemoresponsiveness in a~     post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.~   "
213672|NCT00763087|"~     The purpose of this study is to determine if people with Diabetes Mellitus and peripheral~     neuropathy can increase their activity (i.e. walking or stationary biking) and leg strength~     without having an increase in foot problems compared to a group of people with diabetes and~     peripheral neuropathy that do no exercise.~      Our hypothesis is that the weight-bearing exercise group will achieve greater increases in~     weight-bearing activity (i.e., increased steps/day and cumulative load) and leg strength~     compared to the non-weight bearing exercise group and the non-exercising control group; and~     there will be no clinically meaningful difference in incidence or indicators of foot lesions~     between groups.~   "
213673|NCT00763074|"~     The purpose of this study was to evaluate the effects of 12 weeks' increased daily physical~     activity versus diet restriction on regional fat distribution, insulin sensitivity and~     adipokines including retinol binding protein-4 (RBP-4), leptin, adiponectin, and a new~     marker, adiponectin to leptin ratio (AL ratio), in type 2 diabetic women.~   "
213674|NCT00763061|"~     To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004%~     compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension~     (OH). The study structure is a parallel design. The patients will receive treatment for 12~     weeks.~   "
213675|NCT00763048|"~     To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from~     gingivitis and/or periodontitis.~   "
213676|NCT00763035|"~     The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an~     imaging agent with cardiac MR. If found useful, it will help us establish a protocol for~     regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR).The investigators~     will compare regadenoson with dobutamine so each participant will undergo two studies. A~     cardiac MR stress test with regadenoson and with dobutamine. The investigators participants~     will include patients with history of COPD and Asthma, so it will also help us determine~     feasibility of Regadenoson in these patient's subgroups.~   "
213677|NCT00763022|"~     The purpose of this study was to determine the safety and efficacy of TAK-559, once daily~     (QD), in Type 2 Diabetes subjects.~   "
213678|NCT00763009|"~     The primary objective of this study is to understand why different people respond differently~     to the medication Persantine. The effects of Persantine will be evaluated by performing~     echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart~     in patients undergoing a clinically indicated percutaneous coronary intervention.~   "
213679|NCT00762996|"~     The objective of this study is to evaluate the clinical performance of two daily disposable~     contact lenses.~   "
213680|NCT00762983|"~     The purpose of this study is to collect information on unexpected adverse reactions (ADRs),~     how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin~     (loratadine) when used in children. Patients will be observed while they are taking Claritin,~     and ADRs and symptom scores will be recorded. At the end of treatment, improvement in~     symptoms will be recorded.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
213681|NCT00762970|"~     This study is to investigate whether novel soft contact lens optical designs can slow myopia~     progression.~   "
213682|NCT00762957|"~     The purpose of this study is to evaluate the safety and efficacy of TAK-559, once daily (QD),~     taken in combination with metformin in treating subjects with type 2 diabetes mellitus~   "
213683|NCT00762944|"~     Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and~     Effectiveness Data~   "
213684|NCT00762931|"~     The goal of this study is to validate design for the Resolve™ Stimulator and Proximity~     Electrode and the associated procedure to quickly and safely place an electrode into the~     neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or~     other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm~     that the electrical signal being delivered via this electrode rapidly counters~     bronchoconstriction and improves airway flow.~   "
213685|NCT00762918|"~     Vitamin D deficiency is common in cystic fibrosis. Vitamin D deficiency frequently persists~     despite aggressive treatment with ergocalciferol, a vitamin D preparation also known as~     vitamin D2. Cholecalciferol, a vitamin D preparation also known as vitamin D3,may work better~     to increase vitamin D levels.~      Vitamin D is important for absorption of calcium from the diet and bone health. Vitamin D~     more recently has been found to play a role in regulating the normal inflammatory process.~     Since cystic fibrosis is a state of excessive inflammation, vitamin D may be playing a role~     in cystic fibrosis.~      We hypothesize: cholecalciferol will work better to increase vitamin D levels in patients~     iwth cystic fibrosis and that it will have an effect on markers of inflammation.~   "
213710|NCT00762580|"~     The goal of this study is to find which patients will improve with the nonsurgical treatment~     of physical therapy for the treatment of rotator cuff tears.~   "
213688|NCT00762879|"~     The purpose of this study is to compare healthy children to children who have a chronic~     illness called Juvenile Idiopathic Arthritis (JIA). JIA is a childhood disease that causes~     swollen joints that are often stiff and painful. JIA affects about 1 in 1,000 children age 16~     and younger.~   "
213689|NCT00762866|"~     The purpose of this project is to obtain DNA, brain imaging data, other biological samples~     (e.g., urine, serum), and a comprehensive clinical assessment on patients with schizophrenia~     and other psychotic disorders, bipolar disorder, major depression, and normal volunteer~     controls. Understanding the physical and genetic factors related to these disorders will help~     us make progress in fitting treatments to an individual's needs. Participants will take part~     in a detailed clinical assessment, two blood draws, and an MRI scan over two visits.~     Participants will also be asked to provide urine and saliva samples.~   "
213690|NCT00762853|"~     The objective is to develop a method to determine active ingredient uptake in oral care~     products.~   "
213691|NCT00762840|"~     The study is designed to test the hypothesis that there is a difference in healing kinetics~     and healing rate between teeth treated by conventional endodontic procedure alone and those~     in which such procedure was supplemented with the Apexum Ablator protocol~   "
213692|NCT00762814|"~     Some individuals with Parkinson disease experience freezing during walking which results in~     their inability to move their feet. They often have difficulty starting to move once they~     have stopped. Freezing often results in loss of balance and falling. Oral medications for~     Parkinson disease aren't as effective in treating freezing as it is in reducing other~     symptoms. Another treatment for freezing is instruction in walking using visual targets or~     auditory cues (thinking of a rhythm or beat). These cues can be initially effective for some~     individuals, but the effects do not last. Other types of cues have not been studied. We want~     to examine the effects of two other cues, tactile (touch) or motor (muscle contraction), on~     the effects of freezing.~   "
213693|NCT00762801|"~     RLIP76 (Ral binding protein1) is a 76 kDa splice variant protein encoded by the human gene~     (RALBP1, 18p11.22). It is a multifunctional modular protein found ubiquitously from~     Drosophila to humans, in cells ranging from red blood cells to endothelial cells of the~     brain. Its expression more predominant in breast, heart, liver and less so in colon and brain~     parenchyma.~   "
213694|NCT00762788|"~     The study is to clinically evaluate currently marketed contact lenses when used in an~     extended wear modality of up to seven days/six nights.~   "
213695|NCT00762775|"~     We will study the relative importance of high calcium intake and vitamin D supplementation~     for calcium homeostasis, as determined by serum parathyroid hormone (PTH) and biochemical~     bone markers. We also intend to examine the interaction of vitamin D and calcium intake on~     calcium homeostasis. We hypothesize that optimal calcium supplementation and optimal vitamin~     D supplementation will lead to lower serum levels of PTH and markers of bone resorption~     compared with the placebo. We also theorize that when taken together, optimal calcium~     supplementation and optimal vitamin D intake will result in lower serum levels of PTH and~     bone markers compared with calcium or vitamin D taken alone.~   "
213696|NCT00762762|"~     Clinical research study to determine the anti-plaque efficacy of commerical dentifrices.~   "
213697|NCT00762749|"~     To characterize the pharmacokinetics of diphenhydramine in two pediatric populations:~     children, ages 2 to < 12 years, and adolescents, ages 12 to < 18 years.~   "
213698|NCT00762736|"~     The purpose of this study is to determine the efficacy of pioglitazone, once daily (QD),~     combined with azilsartan in the treatment of subjects with Type 2 Diabetes Mellitus.~   "
213699|NCT00762723|"~     Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion~     device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system~     provides the surgeon with the ability to supplement an interbody device with anterior plate~     fixation. The device's bone-plate interface is enhanced through use of fixed-angled~     screws,variable-angle screws or a combination of both to accommodate various combinations of~     screw configurations, resulting in enhanced fixation tailored to individual patient needs.~     Clinical outcomes data, including a comparison of different screw configurations, is needed~     to support the use and of the Trinica ALP System.~   "
213700|NCT00762710|"~     The purpose of this study is to determine whether the drug prazosin is effective for the~     treatment of alcohol dependency.~   "
213701|NCT00762697|"~     The intent of this protocol is to obtain blood samples from subjects with or without a wound,~     so the blood can be used in wound-related scientific studies. It is also the intent of this~     protocol to salvage debrided wound material that is normally destined for destruction, so it~     can be used in wound-related scientific studies.~   "
213702|NCT00762684|"~     The purpose of this study was to determine the safety and efficacy of TAK-559, once daily~     (QD), in treating subjects with type 2 diabetes mellitus.~   "
213703|NCT00762671|"~     The purpose of the study is to learn how blood vessel function is altered by diabetes. We are~     studying an investigational drug, Ebselen, to see if it can improve the ability of blood~     vessels to relax (widen).~   "
213704|NCT00762658|"~     To investigate dose-response relationship, antipsoriatic efficacy and safety of different~     concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris~   "
213705|NCT00762645|"~     The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering~     efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in~     patients with chronic angle-closure glaucoma (CACG).~   "
213706|NCT00762632|"~     This is a nonrandomized, open-label study to evaluate the efficacy and safety of combination~     treatment of Nilotinib and RAD001 in the treatment of c-kit + AML. Patients refractory to~     standard chemotherapy or not eligible to standard chemotherapy can be included. Patients will~     be treated with 400 mg Nilotinib bid (total daily dose 800 mg). RAD001 will be added after a~     treatment duration of 1 week in a dosage of 2,5 mg/day. Treatment duration will be 25 weeks.~   "
213707|NCT00762619|"~     The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants~   "
213708|NCT00762606|"~     To compare the health economic parameter and clinical outcome of Phacoemulsification with~     small incision cataract surgery (SICS)~   "
213709|NCT00762593|"~     To compare the effectiveness of a transvaginal electrical stimulation by a home use~     programmable device to a placebo device for urinary incontinence in women~   "
213717|NCT00762489|"~     Body temperature measurement is one of the standard vital sign measurements in newborn babies~     in order assess their health status. Temperatures are taken on a regular basis throughout the~     newborn's stay on the well-baby floor. A temperature that is elevated above the normal range~     for age or depressed below the normal range for age may be a sign of illness in a newborn.~     There are many methods that may be used to record this temperature. Traditionally, axillary~     (under the arm) and rectal (in the rectum) sites have been used. Recently, a new method of~     temperature measurement has become available. Temporal artery thermometers are a non-invasive~     method to measure the baby's temperature by means of a light that is shone on the forehead~     that can read your baby's temperature quickly. It is not clear whether this method is~     accurate in the newborn period.~      The purpose of this study is to evaluate the accuracy of temporal artery temperature~     measurement. This will be achieved by observing the axillary measurement, rectal temperature~     measurement, and temporal artery temperature measurement taken at approximately the same time~     in each infant. These measurements will be compared to each other to determine if temporal~     artery thermometry is as reliable a measurement as rectal and / or axillary temperature~     measurements.~      We plan to compare~      Hypothesis: Temporal artery thermometry of the immediate newborn infant is an accurate~     measurement of temperature in this age group.~   "
213718|NCT00762476|"~     The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the~     common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a~     virus that causes many common colds.~   "
213719|NCT00762463|"~     This is a local, multicenter, randomized, active comparator, double-blind, parallel group~     study with extension will be conducted to evaluate the efficacy and safety of celecoxib~     versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).~   "
213720|NCT00762450|"~     To determine the effect of an amino acid on bacterial glycolytic acid formation in human~     interdental plaque.~   "
213721|NCT00762437|"~     The purpose of this study is to evaluate a non-invasive cooling device to determine if cold~     exposure will consistently result in a reduction of subcutaneous fat.~   "
213722|NCT00762424|"~     Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several~     studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been~     carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4~     mg with placebo in regards to rate and time of stone passing and will also look at amount of~     pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on~     time to stone passage and pain relief in Emergency Department patients with kidney stones.~   "
213723|NCT00762411|"~     Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no~     cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid~     (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD~     patients are required to have these amyloid plaques in the brain in order to have a~     definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the~     production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and~     was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in~     blood, spinal fluid and brain in animals tested thus far. This study used several different~     tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some~     patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture of~     amyloid plaques in the brain. Other tests measured the overall function of the brain and~     brain size in some patients. In this trial, patients who initially received placebo (inactive~     sugar pill) were, at a certain point in the study, switched over to active drug,~     semagacestat. In other words, all patients could eventually receive active drug. Each~     patient's participation could last approximately 2 years. Patients taking approved AD~     medications were permitted to participate in this study and continue taking these medications~     during the study. All patients who completed this study had the option to continue receiving~     semagacestat by participating in an open label study.~      Preliminary results from this study (LFBC) (and another similar study LFAN [NCT00594568])~     showed semagacestat did not slow disease progression and was associated with worsening of~     clinical measures of cognition and the ability to perform activities of daily living. Study~     drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been~     amended to continue collecting safety data, including cognitive scores, for at least seven~     months. The CT-Registry will reflect results of analyses from the original protocol in~     addition to those from the amended protocol.~   "
213724|NCT00762398|"~     The Masimo monitor can measure hemoglobin level noninvasively and accuratly~   "
213725|NCT00762385|"~     The objective of this study is to evaluate the clinical performance of two silicone-hydrogel~     contact lenses.~   "
213726|NCT00762372|"~     The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as~     an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in~     term of awakening/recovery from anesthesia.~   "
213727|NCT00762359|"~     The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to~     gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and~     duodenal ulcers in patients receiving long term treatment with low dosage aspirin.~   "
213728|NCT00762346|"~     A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of~     high-level NTX non small cell lung cancer with bone metastasis.~   "
213729|NCT00762333|"~     The purpose of this research is to determine if two proteins in the blood are increased~     during acute myocardial infarction and whether their levels are higher in those who develop~     heart failure than those who do not. These two proteins are produced and potentially released~     when the heart muscle is damaged. They may then be released into the blood and be detected by~     standard method in the research laboratory. At this time, detection of an increase in these~     proteins in the blood is not known to be associated with any disease or myocardial~     infarction.~   "
213744|NCT00762125|"~     Fibromyalgia syndrome (FMS) refers to a set of symptoms that include exhaustion, muscle pain,~     and tender points, where slight pressure can cause pain. Doctors do not know what causes FMS~     or how to cure it, but some treatments have helped relieve its symptoms. Progressive~     exercise, in which exercise is started at low levels and then increased, is one of the most~     reliable treatments, but people with FMS often avoid exercise or stop after completing~     exercise programs. This research will focus on the idea that people with FMS do not exercise~     because they are afraid of injury or have had a negative experience exercising. Participants~     will undergo one or a combination of several different treatments that aim to reduce fear of~     exercising. The different treatments will then be evaluated on their effectiveness in~     reducing disability among people with FMS.~   "
213745|NCT00762112|"~     The purpose of this study was to determine the long-term safety of TAK-559, once daily (QD),~     in subjects with Type 2 Diabetes.~   "
219488|NCT00686023|"~     Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood~     loss, operative complications and postoperative rehabilitation in the management of~     pertrochanteric femur neck fractures.~   "
213730|NCT00762320|"~     Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective~     medications that are approved and available for young children who are HIV+. The liquid form~     is reported to have a very nasty taste and presents difficulties for the children who must~     take the medication twice a day and for their parents who must enforce the medication~     regimen. The children are often well into their teens before they weigh enough to be able to~     take the adult dose tablet (200mg/50mg). A new smaller dose tablet (100mg/25mg) is now~     available. However, it is not known if the liquid and tablet act the same in children. The~     purpose of this study is to switch children from the baseline treatment with the liquid to~     the study intervention treatment with 100mg/25mg tablet form of Kaletra. The study will~     compare children pre-switch and post-switch in terms of how well their HIV is controlled .~     Comparisons of parent and child satisfaction will also be made. Eight to 10 HIV+ children~     currently well managed with a medications including liquid Kaletra will be invited to switch~     from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a~     satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At~     the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the~     parent and/or child will complete the satisfaction survey. In addition, at the switch and 1~     month post switch, a day will be spent in clinic with 5 blood draws to see how much of the~     drug is in the blood stream at different times after the medicine is taken.~   "
213731|NCT00762307|"~     The purpose of this study is to evaluate a non-invasive cooling device to determine if cold~     exposure will consistently result in a reduction of subcutaneous fat.~   "
213732|NCT00762294|"~     Aromatase Inhibitors (AI) are effective for secondary prevention of breast cancer and may~     soon replace tamoxifen as first-line therapy in the treatment of hormone-sensitive breast~     cancer. However, because these medications produce a marked reduction in serum estrogen~     levels, this is likely to result in an increased rate of bone loss and risk of developing~     osteoporosis and fractures in postmenopausal women treated with these agents. Indeed,~     substantial bone loss has been reported in several large clinical trials of AIs. Osteoporosis~     drugs are available that could prevent this loss, but they have frequent side effects and are~     expensive. Thus, treating all women receiving AIs might not be the most appropriate and~     cost-effective approach. A better approach might be to select women at highest risk of bone~     loss and only treat them with antiresorptive agents.~      The proposed pilot study will evaluate women who receive anastrozole or letrozole therapy,~     are receiving adequate amounts of calcium and vitamin D and have baseline normal or~     moderately low bone mass in order to determine if early changes in bone turnover markers~     correlate with bone loss at one year. If data from this pilot protocol support our~     hypothesis, then we would propose a larger trial to confirm it. The ultimate aim is to~     predict which women are at higher risk of bone loss and therefore treat them earlier with~     bone-sparing agents, while those with lower risk could be monitored on conservative therapy.~   "
213733|NCT00762281|"~     The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in~     the treatment of hyperopia, when used as part of the Laser In Situ Keratomileusis (LASIK)~     procedure.~   "
213734|NCT00762268|"~     S-adenosyl-L-methionine (SAMe) is a dietary supplement with antidepressant properties. SAMe's~     mechanism of action remains unclear, but it appears to be distinct from that of conventional~     antidepressants. The purpose of this study is to examine the effect of these properties on~     the mood of bipolar subjects with persistent major depression that has been unresponsive to~     standard pharmacotherapy.~   "
213735|NCT00762255|"~     The purpose of the this study is to see if an investigations cancer treatment called~     vorinostat can be combined with the irinotecan/bevacizumab regimen safely.~   "
213736|NCT00762242|"~     The purpose of this study is to identify and characterize specific chemicals and metabolic~     pathways that change with forearm ischemia. These changes will be compared with forearm blood~     flow and flow-mediated vasodilation of the brachial artery.~   "
213737|NCT00762229|"~     The purpose of this study is to compare the effect on LDL cholesterol levels of converting~     patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10~     milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.~   "
213738|NCT00762216|"~     To assess the rotational stability and the residual refractive cylinder and patient reported~     outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.~   "
213739|NCT00762190|"~     The purpose of this study was to determine the safety of TAK-559, once daily (QD), in~     treating subjects receiving a stable dose of insulin to control type 2 diabetes mellitus.~   "
213740|NCT00762177|"~     To compare the antimicrobial efficacy of three dentifrices on oral bacteria~   "
213741|NCT00762164|"~     The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved~     agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption~     inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter,~     versus a whole simvastatin 20 milligram tablet.~   "
213742|NCT00762151|"~     The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype~     dentrifice as compared to commercial control products following a single use of the~     dentrifice.~   "
213743|NCT00762138|"~     AutoloGel™ Post-Market Surveillance Program~      Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including~     coagulopathies in patients with wounds to which AutoloGel™ was applied.~      Design:Prospective, open label, patient registry. Investigator Sites: 3 Enrollment Size: 300~      Subject Population: Patients with exuding wounds, such as leg ulcers, pressure ulcers, and~     diabetic ulcers and for the management of mechanically or surgically-debrided wounds.~      Primary Objective Safety: Assess the incidence of hematologic (coagulopathies), immunologic~     (including anaphylaxis) and other adverse events associated with the application of AutoloGel~     on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers and during the~     management of mechanically or surgically-debrided wounds.~      Primary Safety Endpoint: Absence of coagulopathies caused by inhibitors to coagulation Factor~     V as determined by a significant prolongation of the prothrombin (PT) time and confirmed by~     severe depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V~     functional inhibitors.~   "
213764|NCT00761865|"~     The purpose of this study is to compare the short term treatment outcome measures of the~     standard of care air cell stirrup brace to that of a high tide fracture boot in patients with~     lateral ankle sprains.~   "
213746|NCT00762099|"~     Pain prior to surgery is of particular concern in patients undergoing total hip arthroplasty~     (THA) since it is the most important predictor of pain and poor function 2-3 years after~     surgery. Previous studies have investigated various treatments for managing pain during and~     after surgery. However, no study has investigated the short and long term effects of~     pregabalin in terms of functional rehabilitation, pain outcome and anxiety following total~     hip arthroplasty. Therefore, the aim of the present study is determine if the following: (1)~     if perioperative pregabalin administration positively influence early rehabilitation and~     recovery of physical function and to determine if these effects maintained at 6 weeks and 3~     months post surgery. (2) To determine if perioperative pregabalin administration reduce~     postoperative movement evoked pain associated with rehabilitation and if these effects also~     maintained at 6 weeks and 3 months post surgery.~   "
213747|NCT00762086|"~     The purpose of this study is to evaluate the safety and efficacy of new intermittent~     pneumatic compression device on initial claudication distance in patients with Peripheral~     Arterial Disease stage II~   "
213748|NCT00762073|"~     This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with~     eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of~     four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit~     the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for~     clinical symptom assessment and safety evaluation (including adverse events and vital signs).~     All study treatments (active drug and placebo) will be administered orally twice daily during~     the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.~   "
213749|NCT00762060|"~     This study is a multicenter, open label, observational, postmarketing surveillance study of~     the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to~     investigate specific aspects of infection rates and hospital length of stay following routine~     use of this device in patients undergoing colorectal surgical procedures.~   "
213750|NCT00762047|"~     The purpose of this study is to evaluate a new injectable bulking agent for the treatment of~     fecal incontinence in adult men and women. This study has been designed to assess the safety,~     effectiveness and performance of Durasphere in adults suffering from fecal incontinence under~     monitored clinical conditions.~      The frequency and severity of fecal incontinence symptoms will be measured using a modified~     Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.~   "
213751|NCT00762034|"~     This study will compare overall survival in participants with Stage IIIB or IV nonsquamous~     non-small cell lung cancer.~   "
213752|NCT00762021|"~     To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof~     SN60AT lens or the AcrySof SN60WF lens.~   "
213753|NCT00762008|"~     The purpose of this research is to determine if two proteins in the blood are increased~     during acute heart failure. These two proteins are produced when the heart becomes~     dysfunctional and unable to contract normally. They may then be released into the blood and~     be detected by standard method in the research laboratory. Thus, the purpose of this study is~     to determine the relation between the change of these two proteins in the blood and the~     occurrence of acute heart failure. At this time, detection of an increase in these proteins~     in the blood is not known to be associated with any disease or heart failure.~   "
213754|NCT00761995|"~     Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing~     Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension~   "
213755|NCT00761982|"~     The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset~     bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered~     acute middle cerebral artery stroke.~   "
213756|NCT00761969|"~     The PID-PAB study aims to test the efficacy of the European Guidelines on Cardiovascular~     Disease Prevention in patients with peripheral arterial disease. Survival, the rate of major~     atherothrombotic events (myocardial infarction, stroke, critical limb ischemia) and the~     incidence of revascularization procedures will be compared between a group of patients with~     stable peripheral arterial disease (PAD) and age- and sex-matched control subjects without~     PAD. Both groups will be receiving up-to-date medical care according to their cardiovascular~     risk based on the European Guidelines on Cardiovascular Disease Prevention in Clinical~     Practice. Yearly follow-up is planned for 5 years. The PID PAB study aims to test (a) whether~     stable PAD is still an adverse prognostic indicator in spite of contemporary preventive~     measures, and (b) to what extent do contemporary preventive measures improve the prognosis of~     patients with PAD in comparison to historic controls, representing the natural history of the~     disease.~   "
213757|NCT00761956|"~     The purpose of this study is to test for significant differences in functional outcomes,~     specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a~     NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative~     range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.~   "
213758|NCT00761943|"~     We are trying to see if ultrasound is a good tool for looking at the changes that happen on~     the inside of the shoulder due frozen shoulder.~   "
213759|NCT00761930|"~     Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival~     inflammation~   "
213760|NCT00761917|"~     The objectives of this study are to assess for a difference between normal and dry eye~     subjects in tear film quality using a diagnostic interferometry device and to determine~     whether there are associations between tear film quality and dry eye symptoms and signs.~   "
213761|NCT00761904|"~     In this randomized controlled trial, we will provide primary care physicians with free~     samples of highly effective generic cardiovascular medications. We will test whether this~     intervention will stimulate cost-effective prescribing, reducing drug costs and improving~     adherence to essential cardiovascular medications.~   "
213762|NCT00761891|"~     The purpose of this study is to obtain a reference range for a newly developed assay of ex~     vivo platelet COX-1 activity in normal volunteers taking a routine clinical dose of aspirin.~   "
213763|NCT00761878|"~     The purpose of this study is to determine the comparative effects of the PlasmaJet neutral~     argon plasma system and the Rhytec Portrait PRS nitrogen plasma system in the treatment of~     aging facial skin~   "
213766|NCT00761839|"~     The purpose of this research study is to evaluate a patient education program for chronic~     wound care. The wound care nurse practitioner (NP) at the Ann Arbor VAMC will use a wound~     self-management after-care summary with approximately half of her patients. This study will~     examine whether using this patient education tool for self-management of wound care results~     in improved patient outcomes.~   "
213767|NCT00761826|"~     The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in~     the treatment of mixed astigmatism up to 6.0 D, when used as part of the Laser In Situ~     Keratomileusis (LASIK) procedure.~   "
213768|NCT00761813|"~     Each year, hip fracture, an injury that can impair independence and quality of life, occurs~     in about 280,000 Americans and 36,000 Canadians. The annual healthcare costs associated with~     this injury are expected to soon reach $9.8 billion in the United States and $650 million in~     Canada. It is important to have in place optimal practice guidelines for the surgical~     handling of this injury. One type of hip fracture, called a femoral neck fracture, is often~     treated with a surgical procedure called internal fixation. When performing internal~     fixation, most orthopaedic surgeons favor using multiple small diameter screws over using a~     single large diameter screw with a sliding plate. However, use of the sliding hip screw might~     in fact result in fewer complications after surgery and reduce the need for a second surgery,~     called a revision surgery. This study will compare the two different surgical procedures to~     determine which one results in better outcomes after surgery.~   "
213769|NCT00761800|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the~     product Dermacyd Teen Care Tangerina Mix.~   "
213770|NCT00761787|"~     The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to~     provide independent evidence of the clinical performance of the non-invasive AlloMap test.~     Sensitive detection of cardiac allograft rejection and dysfunction is the basis for~     successful recipient management. The CARGO II Study will assess the correlation between the~     presence or absence of acute cellular rejection as determined by examination of~     endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating~     transplant centers, 4 are in North America and 13 are in Europe.~   "
213771|NCT00761774|"~     The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16~     years and older with epilepsy. This study permits continued access to treatment for subjects~     who participated in a previous epilepsy study. The study will explore the long-term safety~     and efficacy of brivaracetam.~   "
213772|NCT00761761|"~     The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance~     cognitive abilities (specifically measures of attention, executive function, working memory,~     and visuospatial ability) in persons with bipolar disorder. Secondarily, the investigators~     hypothesize there will be secondary improvements in residual mood/anxiety symptoms, and~     metabolic indices, if impaired (fasting blood glucose and lipids).~      The investigators aim to test these hypotheses by conducting a randomized, placebo~     controlled, add on treatment trial of Sensoril® (added to existing mood stabilizer treatment)~     recruiting 60 subjects with DSM IV-TR bipolar disorder for a period of 8 weeks. Measures of~     cognition, psychopathology and laboratory indices will be utilized for evaluating primary and~     secondary outcomes, along with safety assessments.~   "
213773|NCT00761748|"~     Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.~   "
213774|NCT00761735|"~     Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants~     who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin~     (RBV) and who completed the follow-up in the P02538 Part 1 study (NCT00104052). No study drug~     therapy will be administered during the P02538 Part 2 study. Durability of virologic response~     will be assessed for participants who attained sustained virologic response (SVR) in Part I~     of this study by performing annual Hepatitis C Virus ribonucleic acid (HCV-RNA) testing. In~     addition, this study will characterize long-term safety in all participants who received~     PEG-IFN plus RBV treatment.~   "
213775|NCT00761722|"~     The purpose of this study is to compare the amount of drug that gets into the bloodstream~     between different tablets taken by mouth and an injection under the skin.~   "
213776|NCT00761709|"~     The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering~     efficacy of AL-39256 in patients with open-angle glaucoma or ocular hypertension.~   "
213777|NCT00761696|"~     The primary objectives of the study are:~        -  To determine the safety and the maximum tolerated dose (MTD) of IPI-926~        -  To examine the pharmacokinetic parameters of IPI-926 and its characterized major~          metabolite(s)~        -  To recommend a dose and schedule of IPI-926 for subsequent studies~   "
213778|NCT00761683|"~     To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent~     reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the~     effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction~     scores for pelvic tenderness and indurations; to observe the reduction in the proportion of~     patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated~     with Zoladex 3.6 mg.~   "
213794|NCT00761475|"~     Incisional hernia is the most frequently seen long term complication in surgery causing much~     morbidity and even mortality in patients. Despite studies on the optimal closing technique~     for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %.~     Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use,~     malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge,~     there has not yet been developed a sufficient method for prevention. One specific group of~     high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship~     between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been~     reported. Retrospective and prospective studies have shown an average risk for incisional~     hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients.~     Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after~     midline incision with an incidence of 22% after 12 months. Considering only 50 % of~     incisional hernia will be clinically evident in the first 12 months, the total incidence will~     be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can~     benefit most from prevention. Some small studies have been performed to evaluate the~     usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh.~     These studies show a very low risk for incisional hernias and a low infection rate, even when~     used in contaminated wounds such as colostomal surgery. However, there has not been performed~     an adequate randomized controlled trial to study the prevention of incisional hernias. Our~     hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy~     is effective in patients with aortic aneurysm and in obese patients with a BMI of more than~     27.~   "
219971|NCT00679640|"~     The purpose of this study is to describe the way candesartan is used in heart failure~     treatment in France (treatment initiation and monitoring), treatment stops occurrence and~     reasons for and patients clinical evolution~   "
213779|NCT00761670|"~     Primary objectives~        -  To compare neurocognitive effects of amisulpride with those of risperidone in patients~          with chronic schizophrenia, as assessed by the general cognitive index, a measure of~          overall cognitive functioning in schizophrenia~      Secondary objectives~        -  Secondary analyses will be conducted to determine how the two atypical agents'~          neurocognitive effects compare with regard to their profile of therapeutic action (based~          on individual cognitive domain scores in seven cognitive domains, including speed of~          processing, attention/vigilance, working memory, verbal learning and memory, visual~          learning and memory, reasoning and problem solving and social cognition);~        -  Investigate whether amisulpride elicits more improvement on negative symptoms compared~          to risperidone treatment, as measured by the total score on the Scale of the Assessment~          of Negative Symptoms (SANS) 8 and by the Negative Symptom Subscale of the Positive and~          Negative Symptom Scale (PANSS);~        -  Assess whether amisulpride improves overall functioning and individual domains of~          psychotic symptoms compared to risperidone as measured by the Clinical Global Impression~          (CGI), and the total and positive and general psychopathology subscale scores of PANSS~          and by the individual domains of SANS, respectively;~        -  Evaluate the safety and tolerability of amisulpride and risperidone based on the study~          completion rates, and frequency of abnormal laboratory values, prolactin serum~          concentrations and on the Simpson Angus Scale for Extrapyramidal Symptoms (SAS) 10 and~          the Abnormal Involuntary Movement Scale (AIMS).~   "
213780|NCT00761657|"~     The primary objective of the study is to evaluate the safety, tolerability and~     pharmacodynamic effects of 5 different oral doses of FG-4592 administered two times or three~     times weekly for up to 4 weeks to subjects with Chronic Kidney Disease not requiring~     dialysis.~   "
213781|NCT00761644|"~     The goal of this clinical research study is to learn the highest safe doses of the~     combination of Doxil (liposomal doxorubicin), Avastin (bevacizumab), and Torisel~     (Temsirolimus) that can be given to patients with advanced cancer that has spread or is~     unable to be surgically removed. The safety and effectiveness of this combination of drugs~     will also be studied.~   "
213782|NCT00761631|"~     This open-label, multicenter study is designed to evaluate the safety, tolerability and~     immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than~     15 months up to less than 18 years.~   "
213783|NCT00761618|"~     The goal of this clinical research study is to learn if draining the IPC every day is better~     at than draining it 3 times a week.~   "
213784|NCT00761605|"~     The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone~     extended-release (mechanism to dissolve a drug over time in order to be released slower and~     steadier into the blood stream) in improving or maintaining the subjective symptoms of the~     participants in three participants' groups (that is, by the reason to switch: lack of~     efficacy group, lack of tolerability group, and lack of compliance group) who switched from~     other previous antipsychotic drugs to paliperidone extended-release tablets at flexible~     doses.~   "
213785|NCT00761592|"~     This pilot study estimates the treatment effects of two different types of botulinum toxin~     type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive~     contraction of the muscles around the eye and can lead to repetitive blinking or sustained~     closure of the eyelids.~   "
213786|NCT00761579|"~     The purpose of this study is to investigate the safety and efficacy of flexibly dosed~     paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder~     with symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self).~   "
213787|NCT00761566|"~     In this study, we will test the hypothesis that preconditioning highly trained swimmers using~     skeletal muscle ischemia as the stimulus will improve exercise performance assessment.~   "
213788|NCT00761553|"~     The purpose of this study is to determine the effects of food supplements and strength~     training on appetite, the amount of energy used, and body composition.~   "
213789|NCT00761540|"~     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood~     concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin~     (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin)~     of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be~     observed.~   "
213790|NCT00761527|"~     The purpose of this study is to observe the side effects of desloratadine syrup and how~     effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The~     participants will take desloratadine syrup for 14 days. At the end of treatment, side effects~     will be recorded, as well as how the participants tolerate the medication. Effectiveness will~     also be rated at the end of treatment.~   "
213791|NCT00761514|"~     The primary objective of this study is to evaluate quality of life changes in Puerto Rican~     subjects with Rheumatoid Arthritis treated with Humira (adalimumab) as their first Anti-TNF~     Monoclonal Antibody.~   "
213792|NCT00761501|"~     The purpose of the study is to investigate the uptake in the body of naproxen; one of the two~     active substances in PN400. We also want to show that the body's uptake of naproxen given as~     PN400 is comparable to that of currently marketed naproxen tablets.~   "
213793|NCT00761488|"~     To allow surgeons to obtain clinical experience on the postoperative uncorrected and best~     distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of~     the AcrySof Toric IOL.~   "
213795|NCT00761462|"~     Objective and subjective musculoskeletal evaluations will be performed to determine~     differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we~     can tell what the natural occurrence of such musculoskeletal conditions is in the general~     pediatric population.~   "
213796|NCT00761449|"~     The aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML~     with chromosome 5 aberrations.~   "
213797|NCT00761436|"~     Tolerability and Efficacy of Spheramine will be evaluated after operative implantation~     (Stereotactic Intrastriatal Implantation) in patients with advanced Parkinson's Disease~   "
213798|NCT00761423|"~     The study will be a double-blind randomized single-center clinical trial comparing 3~     treatment groups with chronic midportion Achilles tendinopathy.~   "
235881|NCT00468078|"~     The purpose of this study is to determine whether F-18 FPCIT is effective and safe~     radiopharmaceutical for the objective diagnosis of Parkinson's disease.~   "
213799|NCT00761410|"~     The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional~     stability with a post-operative passive range of motion of greater than 125° of flexion and~     to demonstrate that the range of motion does not compromise the longevity of the implant.~   "
213800|NCT00761397|"~     The goal of this research study is to help patients complete the swallowing and dental care~     exercises they are supposed to perform during radiation treatment.~   "
213801|NCT00761384|"~     90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the~     liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.~   "
213802|NCT00761371|"~     Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients~   "
213803|NCT00761358|"~     The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects~     with Functional Dyspepsia, focusing on the assessment of subjective symptoms.~   "
213804|NCT00761345|"~     People with pancreatic cancer usually have a large amount of the cancer in the area of the~     pancreas and around it when they are diagnosed with it. Or their cancer has spread~     (metastasized)outside that area of the abdomen and is not able to be surgically removed~     (resected). For patients with metastatic disease, one standard treatment is the combination~     of gemcitabine and erlotinib. This combination has shown slightly longer survival compared to~     getting gemcitabine alone. For patients with localized but unresectable disease, the standard~     treatment remains controversial. Early studies showed that chemotherapy and radiation~     together was better than either one used alone. The greatest benefit of external beam~     radiotherapy may be after a period of full-dose chemotherapy alone, to help the rapid spread.~     A problem of beginning treatment with standard radiotherapy is that the doses of chemotherapy~     usually have to be reduced sometimes by half.~      Studies have already shown that low dose radiotherapy (LDRT)is safe. This study will evaluate~     the safety of LDRT instead of standard doses with full dosing of gemcitabine and erlotinib in~     patients with locally advanced or limited metastatic pancreatic cancer. Patients will be~     enrolled in groups of 3 to 6 each with a slightly higher dose of LDRT and erlotinib.~      For patients with locally advanced disease, this protocol also may help because most patients~     develop and die from spread to the liver and abdominal cavity.~   "
213805|NCT00761332|"~     The purpose of this study is to compare the effectiveness of teriparatide versus therapies~     that decrease bone loss to prevent new or worsening back pain in patients with osteoporosis~     seen in clinical practice.~   "
213806|NCT00761319|"~     The purpose of the study is to compare two ophthalmic solutions in patients with open-angle~     glaucoma or ocular hypertension.~   "
213807|NCT00761306|"~     The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine~     over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed~     6-week acute treatment in study NCT00839423 / 11492A.~   "
213808|NCT00761280|"~     In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared~     to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed~     recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO~     grade IV).~   "
213809|NCT00761267|"~     Prospective, open label study to assess the pharmacokinetics, safety & efficacy of~     anidulafungin when used to treat children (aged 1 month - <18 years) with invasive~     candidiasis, including candidemia (ICC).~   "
213810|NCT00761254|"~     The purpose of this study is to make Domperidone available to patients with gastrointestinal~     disorders who have failed standard therapy and who might benefit from it.~   "
213811|NCT00761241|"~     This study is being conducted to find out what effects (good and bad) that a combination of~     treatment with chemotherapy, radiation therapy and surgery has on you and your pancreatic~     cancer. The chemotherapy drugs to be used: Gemcitabine, Docetaxel, Oxaliplatin, 5-FU and~     alpha-interferon. The goal is to decrease the size of the tumor, so that removal by surgery~     can be performed. Current treatments for this stage of pancreas cancer offer less than ideal~     results, with little opportunity for treatment with curative intent.~   "
213812|NCT00761228|"~     The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative~     State or a Minimally Conscious State.~   "
213813|NCT00761215|"~     The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III~     studies in patients with complicated skin and skin structure infections.~   "
213814|NCT00761202|"~     This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when~     administered for one month to patients with mild to moderate dry eye symptoms, with and~     without contact lenses.~   "
213815|NCT00761189|"~     The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER)~     in participants with schizophrenia (psychiatric disorder with symptoms of emotional~     instability, detachment from reality, often with delusions and hallucinations, and withdrawal~     into the self).~   "
213816|NCT00761176|"~     The objective of this study is to compare the reduction in wound surface areas between~     patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy~     (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic~     wound care alone.~   "
213817|NCT00761163|"~     The purpose of this study is to identify the body's response to aerobic vs. resistance~     exercise. Throughout this study, we will examine food intake, appetite, and physical and~     mental well-being before, during, and after aerobic and resistance exercise.~   "
213818|NCT00761150|"~     The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of~     ABT-712, compared to placebo, administered over a 4-week period in participants with moderate~     to severe mechanical chronic low back pain (CLBP).~   "
213819|NCT00761137|"~     The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral~     dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in~     Parkinson's disease (PD) patients.~   "
213847|NCT00760773|"~     The objective of this study is to determine for previously healthy children, who present to~     an ED with acute gastroenteritis, if the probability of daycare absenteeism is significantly~     different in those who receive a probiotic agent compared to those who receive placebo.~   "
219972|NCT00679627|"~     The purpose of this study is to compare the effectiveness and safety of 2 years of treatment~     with galantamine as compared with placebo of patients who have mild to moderately severe~     Alzheimer's disease (AD).~   "
213820|NCT00761124|"~     The purpose of this intervention trial is aiming to increase inform decision- making in~     Latino men regarding prostate cancer screening.~      The investigators propose to find out how much Latino men know about the benefits and risks~     of prostate cancer screening and what factors influence how they decide whether or not to~     have screening. The investigators are also interested in learning how providing education~     information, both verbally and in print, about the risks and benefits of prostate cancer~     screening affects men's interest and knowledge.~      The intervention is an interactive multi-media presentation made up of a small group of 8-10~     Latino men gathered to discuss about prostate cancer, screening methods, treatment, and the~     controversy within the medical community regarding PSA screening. A facilitator guides the~     1-hour discussion and encourages participant interaction. The effect of this intervention was~     tested on 1000 Latino men within Los Angeles county.~      Participants were recruited from 38 community venues (churches, community center, etc.). All~     participants were interviewed before being randomized to receive written (control group) or~     oral (intervention) prostate cancer education material. All of the participants will be~     followed up at 6-months via a telephone interview.~      The investigators hypothesize that the intervention group will have an increase knowledge of~     prostate cancer, will have increase communication with family, friends, and medical provider,~     and will have an increase rate of PSA screening compared to the control group.~   "
213821|NCT00761111|"~     The purpose of this study is to translate and assess an evidence based educational booklet on~     low back pain patients beliefs after lumbar discectomy.~   "
213822|NCT00761098|"~     Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of~     end-stage liver disease with a mortality of up to 10%, primarily due to the development of~     kidney failure. Current standard practice is to treat this infection with broad spectrum~     antibiotics and salt-poor albumin administration on day one and three of treatment. In this~     study the investigators test the hypothesis that the administration of a second dose of~     albumin at 48 hours only to patients with renal insufficiency, is as effective at preventing~     kidney failure as administering the second dose to all patients at 72 hours.~   "
213823|NCT00761085|"~     To determine the pharmacokinetics of methadone in children and adults with SCD who are~     experiencing a painful episode.~   "
213824|NCT00761072|"~     Total intravenous anesthesia(TIVA) is a commonly used anesthetic technique. Although TIVA can~     be accomplished with a variety of drug combinations, infusions of Propofol and Remifentanil~     are often used with dosage adjusted manually by the anesthesia provider.The pharmacokinetics~     of these drugs are well understood, and that knowledge has led to the development of computer~     controlled infusion pumps that can administer the drugs based upon pharmacokinetic models.~     Computer controlled infusion schemes automatically adjust the drug administration based upon~     pharmacokinetic models which typically dictate a tapering infusion scheme. When one considers~     the dosage of a computer controlled infusion it is obvious that manually imitating a similar~     scheme may be difficult.This study will evaluate manually controlled infusion schemes using~     the models built into the Applied Medical Visualizations (Medvis) display and compare the~     manual dosage schemes to the predicted effect site concentrations and pharmacodynamic effect.~   "
213825|NCT00761059|"~     Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of~     preterm infants under CPAP therapy several times a day. Since the use of analgetic and~     sedative drugs is accompanied with multiple side effects these are usually being avoided.~     Glucose 20% has been shown to have an analgesic effect when administered to preterm infants~     previous to some painful procedures (i.e blood sampling).~      In this clinical trial the efficacy of orally administered Glucose 20% for relieving the~     procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a~     cross-over design and is to include 40 patients.~   "
213826|NCT00761046|"~     Retrospective data collection of the CENOS implant comparing with and without BoneMaster HA~     coatings.~   "
213827|NCT00761033|"~     Many medical procedures aimed at helping children can cause them pain and distress. If~     children experience certain levels of pain or distress, it can have long lasting negative~     effects. The emergency department can be a particularly stressful place for children and~     their parents. There are also many procedures that children may have in the emergency~     department that can cause pain and distress. These include procedures such as needle pokes,~     stitches, or setting a broken bone. Two common methods of managing a child's pain in the~     emergency department are drugs and distraction. Drugs are not always practical and may come~     with unwanted side effects. Distraction is often used formally or informally and by parents~     or the health professionals. One form of distraction involves listening to music. This can~     lower the child's pain and distress by moving their attention from the painful stimulus, for~     example a needle poke, to a more pleasant sensation such as familiar children's songs. This~     study will test whether music is useful to help lower pain and distress for young children~     (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line.~     Music is safe and pleasant for children. The results from this study could be important for~     many children receiving medical care.~   "
213828|NCT00761020|"~     The main purpose of this trial is to study whether a certain blood test can reliably identify~     the presence of malaria in people who have been infected with, but who do not have symptoms~     of malaria.~   "
213829|NCT00761007|"~     The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant~     (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.~   "
213830|NCT00760994|"~     The purpose of this study is to determine whether an experiential acceptance therapy~     intervention is effective in the treatment of alcohol dependency and post-traumatic stress~     disorder (PTSD) symptoms in individuals who suffer from PTSD.~   "
213831|NCT00760981|"~     To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and~     whether their cGVHD responds to imatinib mesylate.~   "
213832|NCT00760968|"~     The purpose of this study is to determine the efficacy and safety of TAK-783, once daily~     (QD), taken in combination with methotrexate in subjects with rheumatoid arthritis.~   "
213833|NCT00760955|"~     The purpose of this study is to determine the safety and effectiveness of TAK-583, once daily~     (QD), in the treatment of neuropathy caused by diabetes mellitus.~   "
213834|NCT00760942|"~     This study aims to compare the short-term effects on growth and feeding tolerance of a liquid~     high calorie formula added to human milk versus powdered human milk fortifier in small~     preterm infants.~   "
213835|NCT00760929|"~     This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who~     failed at least one standard chemotherapy regimen will determine the proportion of patients~     with progression-free survival at 12 weeks following combination therapy with R1507 and~     Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to~     receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks.~     Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related~     endpoints including overall survival, objective response rate, time to response, time to~     progressive disease and duration of response will also be evaluated. The anticipated time on~     study treatment is 1-2 years, and the target sample size is <500 individuals.~   "
213836|NCT00760916|"~     This study is an international, multi-center, randomized, double-blind, placebo-controlled~     study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e.,~     endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy~     treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of~     efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical~     history, physical exams, disease evaluation, and exercise tests. At the end of the first~     12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open~     label portion with visits occuring at 4-week intervals.~      Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month~     open-label, extension phase study (FREEDOM - EXT).~   "
213837|NCT00760903|"~     The purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion~     tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any~     correlation of these findings to clinical outcome. MR spectroscopy using 2D-CSI (a multi~     voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may~     reveal areas of injury and quantification of the metabolites from these areas may be used to~     correlate with imaging findings and clinical evaluation. White matter disruption in these~     areas is commonly seen after TBI, caused by diffuse axonal injury. It has been implicated in~     the long term outcomes in these patients, but has been difficult to assess by standard~     radiologic studies.~      By the use of DTI it may be possible to demonstrate damaged white matter tracts which could~     be helpful in the evaluation of traumatic brain injury. Most TBI subjects have injuries that~     involved torque to the brain. This results in a shearing injury to the long white matter~     tracts, which has been hypothesized to be related to cognitive outcome.~      Also, to demonstrate that MRS and DTI prove valuable in predicting outcome in patients of~     moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long~     term (4-6 weeks). Most patients will most likely be followed clinically for over a year, and,~     if clinical indicated, farther scanning can be done at a later date.~      By comparing fraction anisotropy, ADC values, and metabolic ratios by the use of DTI and MRS~     in the adult and pediatric populations, may help to assess differences in recovery.~      Lastly, a comparison between the two groups in changes in brain metabolism and/or white~     matter tract disruption/re-connection after TBI with and/or without links to outcome can be~     done.~   "
213838|NCT00760890|"~     Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested~     the hypothesis that regular provision of a source of iron beginning at 4 months of age~     improves iron status and could prevent iron deficiency. This was a prospective randomized~     trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed~     (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to~     one of two interventions or to control. The interventions consisted in the daily~     administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily~     feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal~     Group). The control group received complementary foods chosen by he parents but no source of~     iron provided by the investigators. The interventions took place from 4 to 9 months. All~     infants were subsequently followed to 2 years of age.~   "
213839|NCT00760877|"~     The primary goal of this study was to determine the rate of confirmed best cumulative~     complete molecular response (CMR) within the first year of study therapy with imatinib or~     nilotinib. The study also explored the impact and significance of the achieved CMR on patient~     outcomes (progression free survival (PFS), event free survival (EFS) and overall survival~     (OS), characterized the kinetics of CMR achieved in both treatment arms and after the~     cross-over.~   "
213840|NCT00760864|"~     The purpose of this study is to evaluate the safety and efficacy of TAK-715, twice daily~     (BID), in the treatment of rheumatoid arthritis signs and symptoms in patients with a partial~     response to methotrexate.~   "
213841|NCT00760851|"~     The purpose of this study is to determine the effectiveness of probiotics (popularly referred~     to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent~     absences from school/daycare centers of children two to four years old that attend daycare at~     least 3 days per week. Two yogurt drinks will be administered, one containing a specific~     strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will~     experience fewer illnesses and absences from daycare.~      In this study, participants will be asked to:~        1. Give their child 4 oz. of the test yogurt each day for 90 days~        2. Keep a daily diary of their child's health~        3. Collect 3 stool samples from their child at the start, middle, and end of the study~        4. Speak with research personnel on a bi-weekly basis regarding their child's health~        5. Ensure that their child to consume any yogurts or probiotic-containing products for 110~          days of the study~   "
213842|NCT00760838|"~     The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of~     azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain~     inadequately controlled despite GINA (2006) step 4 or 5 therapy.~   "
213843|NCT00760825|"~     The purpose of this study is to determine whether the killed bivalent (O1 and O139)whole cell~     oral cholera vaccine(Shanchol™) is safe and effective in the treatment of Vibrio cholerae.~   "
213844|NCT00760812|"~     This study will compare the effectiveness of two parent-based programs for helping young~     children at risk of autism.~   "
213845|NCT00760799|"~     The purpose of this study is to evaluate the benefits of anulus fibrosus repair utilizing~     Xclose™ compared to a discectomy without anulus fibrosus repair.~   "
213846|NCT00760786|"~     The purpose of this study is to determine whether intensive lipid lowering and Omega-3 fatty~     acid are effective in the treatment of coronary atherosclerotic plaque.~   "
213848|NCT00760760|"~     Inflammation in the adipose (fat) tissue is an important condition leading to metabolic~     derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids~     exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity.~     This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose~     tissue inflammation in morbidly obese patients.~   "
213849|NCT00760747|"~     Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not~     tolerating or not responding well to stimulant therapy will be included in this study. Two~     different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10~     weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be~     compared between the two different switching approaches.~   "
213850|NCT00760734|"~     This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric~     oxygen therapy can improve cognition and brain imaging in subjects with either chronic~     mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or~     chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.~   "
213851|NCT00760721|"~     The purpose of this study is to design an intervention to increase hepatitis B (HBV)~     screening among Korean Americans.~      The investigators will design a culturally specific intervention (educational sessions) and~     test the effect of the intervention on 1200 Korean Americans.~      All subjects will be interviewed before the intervention/control sessions and 6 months after~     the sessions to assess HBV screening levels in the two groups. Self-reported HBV screening~     will be verified by a review of subjects' medical records.~      The primary study hypothesis is that the intervention group will have a higher rate of HBV~     serologic testing at follow-up compared to the control group.~   "
213852|NCT00760708|"~     Persantine is a drug that is routinely used to determine blood flow to the heart in the~     diagnosis of coronary heart disease. Persantine causes an increase in the adenosine level in~     the blood. Adenosine is a naturally occurring substance in the body that can increase blood~     flow. Adenosine is normally removed from the bloodstream by an adenosine transporter, which~     is a protein that takes up adenosine from the blood into cells. The increase in adenosine~     levels in the blood is variable, and the cause for this variability is unknown. A mutation~     for this transporter gene may contribute to this variability, and may alter its function.~     Thus, the purpose of this study is to determine the relationship between the mutation and the~     transporter function.~   "
213853|NCT00760695|"~     A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist.~      Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol~     compared to placebo~      Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.~   "
213854|NCT00760682|"~     There is currently not sufficient evidence that hyperbaric oxygen (HBO) benefits the surgical~     removal of necrotic bone in osteoradionecrosis patients. This study aims at testing the~     hypothesis that HBO does improve healing after surgical removal of necrotic bone in~     irradiated previous head and neck cancer patients compared to not receiving HBO.~   "
213855|NCT00760669|"~     The purpose of this observational study is to evaluate the safety and effectiveness of~     infliximab injection under actual conditions of use in participants, and to learn more about~     its adverse events.~   "
213856|NCT00760656|"~     Childhood cancer predisposes to health risks that may not become apparent until many years~     after completion of therapy. The SJLIFE protocol is designed to establish a lifetime cohort~     of childhood cancer survivors treated at St. Jude Children's Research Hospital to facilitate~     evaluation of health outcomes in aging adults surviving pediatric cancer.~      The study focuses on the following Primary and secondary objectives:~        -  To establish a lifetime cohort of childhood cancer survivors treated at St. Jude~          Children's Research Hospital to facilitate evaluation of health outcomes in aging~          children and adults surviving pediatric cancer.~        -  To estimate the prevalence, cumulative incidence, and latency of selected late treatment~          complications following predisposing therapeutic exposures in children and adults~          surviving pediatric cancer.~        -  To identify treatment, genetic, demographic, and psychosocial / behavioral related~          predictors of adverse health outcomes.~        -  To develop risk profiles for adverse health outcomes across the age spectrum to guide~          development of clinical screening guidelines and risk-reducing interventions.~        -  To identify factors that may be protective against the development of specific late~          treatment complications.~        -  To generate data for a series of future hypothesis-driven trials~        -  To serve as a source for the collection of samples from child and adult volunteers for~          future SJLIFE research.~        -  To collect health outcomes data on a community control population for comparison~          purposes.~   "
213857|NCT00760630|"~     Newly developed diagnostic parameters have potential to differentiate between epicardial~     disease and microvascular dysfunction with the help of anatomical details and physiological~     endpoints and can be used in present clinical settings.~   "
213858|NCT00760617|"~     The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline~     Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older.~      This protocol posting deals with objectives & outcome measures of the extension phase at year~     1. The objectives & outcome measures of the primary phase are presented in a separate~     protocol posting (NCT number = 00540592).~   "
213859|NCT00760604|"~     The purpose of this study is to test 2 different methods of surgery to remove cancer in the~     esophagus. This research is being done to see whether removing more tissue and lymph nodes~     surrounding the tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers~     better control of the cancer than removing less tissue and lymph nodes (known as non-en bloc~     esophagectomy).~   "
213871|NCT00760448|"~     This trial is conducted in UK. The aim of this clinical trial is to investigate lowering the~     blood sugar and symptoms experienced during hypoglycaemia~   "
213872|NCT00760435|"~     The purpose of this study is to determine whether the addition of infliximab to standard~     primary therapy of intravenous immunoglobulin (IVIG) and high dose aspirin will reduce~     resistance to therapy in acute Kawasaki disease (KD).~   "
213873|NCT00760422|"~     The study is conducted in order to evaluate the performance of the NIT thrmometer by~     comparing the predictive measurement to equilibrium measurement and to make a final tuning to~     the thermometer algorithm.~   "
213860|NCT00760591|"~     Oral phosphate purgative is the preferred bowel regimen on the basis of better tolerability,~     cost effectiveness, and efficacy. There are also numerous reports of patients with even~     previously normal renal function developing acute and chronic kidney disease after use of~     oral phosphate purgative. Several uncontrolled case reports and case series suggest a~     potential link between oral phosphate and acute kidney injury and/or chronic kidney disease1.~     Its use is contraindicated in patients with preexisting renal disease because of the risk for~     developing acute renal failure, so called acute phosphate nephropathy, or electrolyte~     disturbance. Since most of the outpatients who are going to undergo a colonoscopy are exposed~     to this agent, it is important to detect or prevent vulnerable patients. We would seek a~     sensitive and rapid diagnosis method of acute kidney injury following sodium phosphate bowel~     preparation. Within a few hours, NGAL mRNA is highly upregulated after kidney injury, such as~     renal ischemia-reperfusion and cisplatin nephropathy, NGAL induction precedes the elevation~     of classical markers for kidney damage such as serum creatinine. The investigators will~     investigate the change of NGAL following sodium phosphate bowel preparation.~   "
213861|NCT00760578|"~     The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type~     2 diabetes.~   "
213862|NCT00760565|"~     This single center, multiple ascending dose study will assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics of RO4905417 at different doses in healthy volunteers~     and patients with peripheral arterial disease. Three groups of 10 healthy volunteers will~     receive RO4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total~     of 3 infusions. In addition, two groups of 6 PAD patients will receive RO4905417 (either~     3mg/kg, 7mg/kg) or placebo and 1 group of 20 PAD patients will receive 20mg/kg RO4905417 or~     placebo iv every 28 days for a total of three infusions. The study will have an adaptive~     design with ongoing assessment of safety and tolerability prior to initiation of the next~     dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 28 day intervals.~     The anticipated time on study treatment is 3-12 months, and the target sample size is <100~     individuals.~   "
213863|NCT00760552|"~     The long-range goal of this research is to advance understanding of long-term blood pressure~     (BP) control in patients with uncontrolled hypertension (HTN). The work builds on our~     experience in implementing new models of care in Veterans Affairs (VA) and non-VA settings,~     including three National Institute of Health (NIH) studies of pharmacist-based HTN~     management. The long-term effectiveness of such models, especially in veterans, is unknown.~     Thus, the primary goal of this study is to evaluate how to sustain long-term BP control in~     veterans with HTN following a 6-month intensive pharmacist intervention.~      This study will enroll veterans with uncontrolled HTN into a 6-month intensive~     pharmacist-based intervention. Following this initial intervention, participants will be~     randomized to continued intervention or a one-time patient and provider education~     intervention. BP will be compared in the two groups over a 2-year follow-up period. The~     intervention to control and sustain BP will follow VA guidelines and include: 1)~     comprehensive medication assessment by the pharmacist; 2) an explicit plan to intensify~     treatment if indicated; 3) strategies to improve adherence; and 4) follow-up pharmacist~     visits to sustain BP control. The intervention is based on models identified in a recent~     Agency for Healthcare Research and Quality (AHRQ) report as being the most potent strategies~     to improve BP. The study will benefit from a strong research team with expertise in guideline~     development, implementation science, quality measurement, and behavioral science. The study~     will also provide important information on the degree to which BP control deteriorates after~     patients are referred back to usual care. The specific aims and related hypotheses of the~     study are to:~      Aim 1:Compare BP control in patients randomized to long-term continuation of the pharmacist~     intervention or to a less intense one-time patient and provider education intervention.~      Hypothesis 1a: Patients randomized to the continued pharmacist intervention will have higher~     rates of BP control 24 months after randomization.~      Hypothesis 1b: Patients randomized to the continued pharmacist intervention will have lower~     mean BP 24 months after randomization.~      Aim 2: Compare antihypertensive medication intensification in patients randomized to the~     continued pharmacist intervention or the less intense intervention.~      Hypothesis 2: A higher proportion of patients who continued the pharmacist intervention will~     have medication intensification over the 24-month follow-up.~      Aim 3: Compare medication adherence in the two intervention groups. Hypothesis 3a: Medication~     adherence will be higher in patients randomized to the continued pharmacist intervention~     group during the 24 month follow-up period.~      Hypothesis 3b: Improvements in medication adherence will be associated with improvements in~     BP during each study interval.~   "
213864|NCT00760539|"~     The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness~     of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma~     or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997)~     and Japan (C-08-08, NCT00760539).~   "
213865|NCT00760526|"~     The purpose of this study is to determine the efficacy, tolerability, safety, and effect on~     quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.~   "
213866|NCT00760513|"~     Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS,~     yet there is presently no licensed treatment or validated approach to management. NAFLD~     predisposes to increased risk of type 2 diabetes, increased risk of cardiovascular disease~     and may progress to chronic irreversible liver disease.~      In NAFLD patients, the investigators will test the hypothesis that treatment with long chain~     n-3 fatty acid supplementation for 18 months favourably influences bio-markers for NAFLD and~     risk factors for cardiovascular disease and type 2 diabetes.~   "
213867|NCT00760500|"~     The surveillance of influenza virus among children with febrile reparatory complaints~     attending the pediatric clinic in Shantou is an epidemiologic study to identify the type~     (influenza A or B) and the subtype of Influenza A of the isolates from children with febrile~     respiratory complaints who attend the pediatric clinic of the first Affiliated Hospital,~     Shantou University Medical College, Shantou Guangdong, China. Also this study investigates~     the genetic composition of all segments of isolated strains using standard molecular~     techniques and to make available the new strains of influenza viruses isolated from such~     children for the formulation of influenza vaccines. Clinical manifestation of the respiratory~     illness is recorded and single nasopharyngeal swab is obtained from eligible children. Viral~     culture is performed on the nasopharyngeal secretions. If influenza is isolated, this is~     characterized if it belongs to influenza A or B. If the virus is characterized as influenza~     A, further antigenic studies is done to determine subtype of influenza. Viral isolates is~     further studied to determine the genetic composition of the virus. Information obtained from~     the viral isolates is shared with the WHO and the CDC.~   "
213868|NCT00760487|"~     The purpose of this study is to evaluate the effect that placement and power of the AcrySof~     Toric has on post-operative visual acuity and spectacle independence for distance vision.~     This will be determined by comparing manifest refraction pre-operatively and post-operatively~     and by evaluating the rotational stability of the lens over time.~   "
213869|NCT00760474|"~     The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by~     evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance~     imaging) is an efficient way to show whether new pain medications are effective in treating~     fibromyalgia.~   "
213870|NCT00760461|"~     The primary objective of this study is to prescribe oral domperidone for patients with~     gastroparesis who have failed or suffered adverse effects from standard medical therapy.~   "
213876|NCT00760383|"~     The general hypothesis is that in older adults muscle regrowth after an acute musculoskeletal~     stress will be positively influenced by traditional physical rehabilitation, and further~     enhanced by nutritional supplementation. Using state-of-the-art stable isotope methodologies~     for the study of muscle metabolism and methodologies for the measurement of cell signaling,~     we will test the following specific hypotheses: 1) Total knee arthroplasty (TKA) induces an~     acute net protein catabolism mainly by reducing muscle protein synthesis; 2) TKA induced~     catabolism is attenuated by the ingestion of essential amino acids (EAA); 3) EAA~     supplementation in combination with physical therapy (PT) will stimulate muscle protein~     synthesis and mTOR signaling to a greater extent than PT with Placebo; and 4) EAA~     supplementation during TKA PT rehabilitation will improve muscle strength, muscle volume and~     functional outcomes to a greater extent than PT with Placebo.~      Public Benefit: This research will focus rehabilitation efforts on specific and currently~     unresolved mechanisms responsible for muscle loss following total knee replacement in older~     adults. While knee pain due to bone arthritis is often alleviated after knee replacement,~     complete return of physical function and independence is difficult to achieve. This research~     will help to restore physical function and independence in the rapidly growing population of~     older adults with knee arthritis.~   "
213877|NCT00760370|"~     The investigators major aim is to determine whether there is a difference in the retention of~     zoledronic acid in multiple myeloma patients, compared to patients with breast cancer~     metastasis to bone. In addition the investigators wish to analyze if the retention of~     zoledronic acid is correlated to the extent of bone resorption/formation, and if there is a~     tendency to changes in retention with sequential treatment.~   "
213878|NCT00760357|"~     Once the patients are identified that have a full thickness wound on a limb clearly~     identified as having critical limb ischemia, these patients will be evaluated. The data that~     will be extracted from each chart will include patient's age, patient's gender, number of~     office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic~     administered, number of hyperbaric oxygen treatments, and if the wound healed.~   "
213879|NCT00760344|"~     The purpose of this study is to determine the efficacy and safety of SYR-472, once daily~     (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with~     diet and exercise, or by taking metformin.~   "
213880|NCT00760331|"~     Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to~     TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2~     mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients~     is unknown.The aim of this study is to follow a cohort of patients with TCF2 mutation and~     initially presenting renal anomalies alone.~   "
213881|NCT00760318|"~     The purpose of this study is to evaluate if there is an improved response in CD symptoms when~     Keppra is used as adjunctive therapy to Botox.~   "
213882|NCT00760305|"~     The main aim of this study is to evaluate whether a patient education programme on cancer~     pain management compared to standard care decreases pain and increases patients quality of~     life. The investigators hypothesis is that patients and family caregivers who receive the~     intervention will have improved outcomes. Patients and family members are seen in their homes~     by the nurses doing the intervention over 6 weeks. Patients keep a diary of their pain and~     medication intake.~   "
213883|NCT00760292|"~     Background: Genetic risk-markers associated with T2DM are thoroughly studied. So far, only a~     few genetic variants, also termed single nucleotide polymorphisms (SNP's), have been~     replicated in several studies and each of them gives only limited explanation for the growing~     incidence of T2DM. The hypothesis of the present study is that determination of combinations~     of genetic variants by SNP-chip technology may improve the prediction of T2DM, complications~     and efficacy of treatment compared to the methods previously used including genome wide~     association (GWA) studies. The SNP-chip/ DNA microarray makes it possible to study several~     SNP's association with T2DM, one by one but also in combination.~      Aims: To study whether specific genetic variants, and combinations of these, 1) are present~     with higher prevalence in patients with T2DM than in the normal population, 2) are associated~     with specific diabetes-related complications and 3) the effect of the anti-diabetic~     treatment.~      Methods: During the next three years 1000 patients with T2DM and 1000 healthy, non-diabetic~     persons will be included in the study, and examined by blood samples, a questionnaire and~     clinical evaluation, all in one visit. Initially, we will perform DNA analyses on blood~     samples from 372 patients included in another clinical study from our department. Description~     of genetics will be done by a DNA-chip with approximately 70 SNP's, which have previously~     been reported to be associated with T2DM.~      Results and conclusions: It is expected that the result of this project can help us~     predicting T2DM, diabetes-related complications and individualizing treatment to the~     individual patient with T2DM.~   "
213884|NCT00760279|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of~     IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is~     similar in the 24-<32 week and 32-<37 week neonate. The dose of 10 mg/kg has been chosen on~     the basis of previous pediatric pharmacokinetic studies.~   "
213885|NCT00760266|"~     The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed~     dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in~     older population with Stage 2 systolic hypertension.~   "
213886|NCT00760253|"~     This study is to find the fewer side effects formula of anesthesia for TVOR patients, to~     compare the BIS level during emergence and to find the correlation between BIS and~     transcutaneous carbon dioxide concentration.~   "
213887|NCT00760240|"~     The investigators are interested in seeing how people with low vision (decreased visual~     acuity or restricted visual fields) instill eye drops into their own eyes. The investigators~     hypothesis is that this population will have more difficulty with self-instillation of drops~     than a better-seeing population. The investigators aim to explore whatever factors may be~     involved in preventing this population from getting prescribed eyedrops into their eyes,~     whether it is more related to visual field or visual acuity.~   "
213921|NCT00759798|"~     The goal of this clinical research study is to learn more about the characteristics of CLL,~     including genes and chromosome abnormalities and proteins expressed by the leukemia cells,~     which may help doctors predict if patients who receive standard treatment (fludarabine,~     cyclophosphamide, and rituximab) for the first time will experience a complete remission.~   "
213888|NCT00760227|"~     The overall aim of the proposed project is to evaluate the impact of a health promotion~     intervention for children undergoing bone marrow or stem cell transplant (BMT). The~     intervention is complementary in nature, designed to increase the experience of positive~     affect and reduce somatic distress and mood disturbance, that is, to improve overall child~     well-being. The study will utilize a positive psychology model, exploring the hypothesis that~     improved outcomes will be mediated by the increased experience of positive affect states~     brought about by the intervention. The primary focus is on a child-targeted intervention that~     includes massage therapy and humor therapy. The study will also assess whether the addition~     of a similar parent-targeted intervention involving massage therapy and relaxation training~     will provide significant benefits beyond those provided by the child-targeted intervention~     alone. The study will utilize a 3-group design, with participants randomized to receive:1) a~     child-targeted intervention (HPI-C); 2) a child targeted intervention plus a parent-targeted~     intervention (HPI-CP); 3) standard care (SC). Primary outcomes include child positive affect,~     somatic distress and mood disturbance, as well as measures of parental positive affect and~     distress. Additional objectives of the study include examining the impact of the intervention~     on short-term medical outcomes, as well as measures of child health-related quality of life~     and parent and child post-traumatic stress symptoms (PTSS) at 6 months post-BMT. Analyses~     will explore hypotheses specific to the positive psychology model, testing the role of~     positive affect and dispositional optimism as mediators and moderators of the intervention on~     child and parent well-being. We will also obtain pilot data examining the effect of the~     interventions on neuroendocrine and neuroimmune markers of stress.~   "
213889|NCT00760214|"~     The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil,~     once daily (QD), compared to ramipril for treating Essential Hypertension.~   "
213890|NCT00760201|"~     Interviewing hospital executives, physician administrators and hospital legal counsel who~     work in a hospital setting (academic, governmental, private or community hospital) about~     their perceptions concerning current and future end-of-life care provided in their facilities~   "
213891|NCT00760188|"~     Prospective data collection on clinical and radiographic outcomes of Cementless oxford~     Partial Knee.~   "
213892|NCT00760175|"~     The influenza virus, commonly called the flu, is a common source of infection in lung~     transplant patients and can often lead to pneumonia and possibly rejection. The annual~     influenza vaccine is the most important strategy used to prevent infection but it is not~     effective in all lung transplant patients. It has been thought that the response to the~     vaccine may be improved if it is given into the skin (intradermal) rather than the muscle~     (intramuscular). We hypothesize that a significantly greater proportion of patients will~     respond to vaccination using the intradermal influenza vaccine compared to the intramuscular~     vaccine.~   "
213893|NCT00760162|"~     The bowel can serve as a complement to the kidneys' excretory function~      A specifically formulated probiotic product comprised of defined and tested microbial strains~     may afford renoprotection in what has been called enteric dialysis® Confirm the alleviation~     of uremic syndrome hypothesis Determine the outcome of probiotics treatment Confirm U.S.~     FDA's Generally Recognized As Safe (GRAS) status - if needed~   "
213894|NCT00760149|"~     In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of~     higher than standard doses rifampicin will be studied during the intensive phase of~     tuberculosis (TB) treatment. Patients enrolled in this study will either get the standard TB~     regimen (including 600 mg rifampicin; first study arm), or 900 mg rifampicin plus isoniazid,~     ethambutol and pyrazinamide in standard dosages (second study arm), or 1200 mg rifampicin~     plus the other drugs in standard dosages (third study arm). All patients will get the~     standard TB regimen during the continuation phase of treatment.~   "
213895|NCT00760136|"~     Background Previous studies have a great discrepancy concerning the effects of quadriceps~     contraction on patellar lateral displacement and tilt in patients with patellofemoral pain~     syndrome. This discrepancy may be caused by lack of information regarding to classifications~     of patellofemoral alignment under quadriceps relaxed. We hypothesized quadriceps contraction~     has different effects on each type of patellofemoral malalignment.~      Methods The investigators expect to recruit 150 subjects with patellofemoral pain syndrome to~     participate in this study. All patients underwent computed tomography imaging of symptomatic~     knees, with and without quadriceps muscle contraction in 0°, 15° and 30° of knee flexion.~     Patellar lateral condyle index and patellar tilt angles of Sasaki and modified Fulkerson were~     measured to investigate the effect of quadriceps contraction on patellar repositioning.~   "
213896|NCT00760123|"~     OBJECTIVE: To find out the effectiveness of early application of physical therapy in the~     prevention of lymphedema after breast surgery and lymphadenectomy.~      DESIGN: Randomized, controlled and single blinded clinical trial. Three years duration.~     Patients will be randomly assigned to one of these groups: Experimental group: Early physical~     therapy + training in means of prevention; Control group: just training in means of~     prevention. In both groups several physical therapy assessments will be undertaken: 1st~     before surgery; 2nd immediately after surgery; 3rd after completing intervention; 4th, 5th~     and 6th after 3, 6, 12 and 24 months.~      SUBJECTS: Women with breast cancer treated with breast surgery including lymphadenectomy in~     Principe de Asturias Hospital, provided that there is no contraindication for physical~     therapy, and after reading, understanding and freely signing an informed consent form.~      SAMPLE SIZE: A total of 116 subjects will be included in the study (58 subjects in each~     group), assuming a 15% of drop-outs and at least 20% reduction, with a statistical power of~     60%.~      DATA ANALYSIS: To find out the effectiveness of intervention we will compare the rate of~     lymphedema in both groups by means of a logistic regression analysis, in which the main~     factor is the intervention group. Other factors aimed to control the effect of the~     intervention will also be included. In order to compare the rate of appearance of lymphedema~     in both groups, a survival analysis will also be included.~   "
213897|NCT00760110|"~     Previous cross-sectional studies have demonstrated that blood pressure (BP) measurements at~     home (HBP) in the morning offer stronger predictive power for micro- and macrovascular~     complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure~     measurements (CBP). The present study examined which of HBP or CBP provides the stronger~     predictive power for outcomes by comparing cumulative events between hypertensive and~     normotensive patients over 6 years in a prospective, longitudinal study of patients with type~     2 diabetes.~   "
213922|NCT00759785|"~     A study to evaluate the response of growth factor signatures (GFS) to a single dose of~     dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive~     luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in~     the GFS in at least 40% of participants.~   "
213923|NCT00759772|"~     Decreased bone strength is a common and serious medical problem present in many women with~     anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to~     suffer broken bones than women with normal bone strength.~      We are investigating whether a hormone that is naturally produced by the human body --~     parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.~   "
213898|NCT00760097|"~     People who have depression often have symptoms besides sad mood. Cognitive symptoms, such as~     poor memory, concentration, and decision making, are associated with disability in many~     spheres of life, and these symptoms often persist even when antidepressant treatment improves~     other symptoms (mood, energy, sleep, anxiety). Antidepressants alone fail to produce full~     remission for many patients, so it is important to study adjunctive treatments which can be~     added onto medication treatment and help restore cognitive function. The method of~     transcranial direct current stimulation (tDCS) has been shown by others to improve working~     memory and cognitive functions, and also to help with other symptoms of depression. tDCS~     involves passing a small, constant current between saline-moistened pads placed on the scalp.~     In this proposed study, 20 individuals with major depression who have cognitive difficulties~     despite taking antidepressants will participate. Over the course of a two-week period, each~     person will receive 5 sessions of either active tDCS or inactive treatments, in addition to~     their medication. Each session lasts for 20 minutes, and will be administered on alternating~     days (M-W-F). Assessments of depressive symptoms, cognitive function, and brain activity will~     be made prior to any sessions, after the first one, and after the fifth (final) session;~     brain function will be assessed by measuring the brain's electrical activity (brain waves).~   "
213899|NCT00760084|"~     The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia~     (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the~     DACO-018 study.~   "
213900|NCT00760071|"~     In patients with Cystic Fibrosis (CF) the clinical course of lung disease is crucial for~     individual prognosis and life expectancy.~      Imaging modalities are important in the assessment of follow up of structural lung changes~     and monitoring of pulmonary complications in CF. Although high resolution computed tomography~     (HRCT) is the accepted gold standard for evaluation of morphological lung changes in CF,~     chest-X-ray is widely used as standard imaging procedure for assessment and follow up in~     these young patients due to less radiation exposure.~      Magnetic resonance imaging (MRI) has not been used for lung imaging in CF so far. Studies~     from the 80's and early 90's were not able to show any impact for the use of MRI in CF. Due~     to recent technical developments MRI of the lung became possible.~      Our study group was able to show that MRI is a competitive imaging modality for evaluating~     changes of the CF-lung in comparison to the gold standard (HRCT).~      So far only patients from the age of 6-7 years were examined. According to recent studies CF~     is a disease which starts in utero. Therefore it can lead to extensive pulmonary changes even~     in infants and young children. In this age group lung function testing is difficult and not~     broadly available. An early optimized therapy is crucial for the long term course and outcome~     of the pulmonary disease.~      The aim of this study is to evaluate morphological and functional MRI for early diagnosis of~     lung changes in children (0-6 years) with CF.~   "
213901|NCT00760058|"~     The objective of the study is to compare the visual outcomes of three aspheric monofocal~     intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.~   "
213902|NCT00760045|"~     The purpose of the study is to observe lacrimal fluid condition (tear film break-up time)~     chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and~     vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention~     time between them.~   "
213903|NCT00760032|"~     The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding~     protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well~     as with the development of severe infectious events in cirrhotic patients with ascites. As a~     secondary purpose, the study will evaluate the effect of a prophylactic administration of~     ciprofloxacin on LBP, cytokines and infections in the same patients.~   "
213904|NCT00760019|"~     The purpose of this study is to determine whether reducing inflammation in blood vessels with~     an aspirin-like drug called salsalate will improve blood vessel function.~   "
213905|NCT00760006|"~     The primary objective of this study is to determine the efficacy of administering a single~     dose of preoperative antibiotics to prevent complications in patients undergoing primary~     closure of a cleft secondary palate. Secondary objective of this study is to evaluate the~     effects of preoperative antibiotics administered on post operative outcome following primary~     closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic~     antibiotics in cleft surgery to~        -  decrease the incidence of surgical sight infections~        -  speed the progression of postoperative healing~        -  improve the final quality of wound healing achieved~        -  decrease the rate of palatal fistula formation~   "
213906|NCT00759993|"~     A majority of patients who suffer from mental illness are treated with serotonin regulating~     FDA approved medications. Some of these medications also block histamine transmission,~     increase blood prolactin levels, induce insulin resistance, hyperlipidemia, and promote~     sedation. All of which lead to weight gain and obesity. Many of these drugs are generally~     safe and effective but do carry the risk of a long term side effect in that acute and gradual~     weight gain of 10-30 pounds over a few months to a year of treatment. The detrimental gain of~     7% of pre-drug weight is reported with many antipsychotics, mood stabilizers and some~     antidepressants. This weight gain may subsequently add to medical co-morbidity ( ie diabetes,~     hypertension, osteoarthritis, coronary artery diseasem, hyperlipidemia… ) This therapeutic~     manipulation of brain serotonin functioning may be associated with abnormal increases in~     carbohydrate cravings, consumption and weight gain. It is possible that insulin resistance~     occurs as a direct effect or as an indirect effect of weight gain, particularly in patients~     prone to weight gain or diabetes due to genetic loading. Leptin, a chemical associated with~     feedback signaling that reduces appetite and adipose tissue growth may also become~     insensitive. These multiple insults may lead to the worst weight gain in patients taking~     clozapine, olanzapine, and mirtazapine.~      Diet and exercise and lifestyle modification are the usual initial interventions, though~     being depressed, anxious, bipolar, or schizophrenic often interferes with the ability to make~     these changes. In fact most of the studies which look at these weight loss interventions~     occur in patients who are institutionalized, on restricted diets and may respond to token~     economy systems while on longer term inpatient unit stays. This token economy approach is not~     easily translated to usual outpatient or short term inpatient practice settings. In these~     settings, if lifestyle modification approaches fail, patients may be placed on FDA approved~     diet medications (sibutramine, orlistat, ionamin…) which carry significant side effect risks.~     Some patients are even placed on the epilepsy medications such as zonisamide or topiramate at~     an even greater side effect risk.~      In a similar weight gain prone group, there is growing literature in the diabetes population~     that the use of high dose chromium improves (lowers) insulin resistance by way of increasing~     insulin binding to cells, receptor numbers, and insulin receptor kinase activity. Lower~     fasting blood glucose levels in the blood generally occurs. Some reports show a reduction in~     blood lipid/cholesterol levels at higher chromium dosing as well. Recently, chromium~     piccolinate was studied in depressed patients, especially those with atypical features~     (usually fatigue, weight gain, carbohydrate cravings). Although there was no change in~     depression symptoms overall, carbohydrate cravings improved. This paper was presented at the~     2005 American Psychiatric Association Annual Meeting in Atlanta. As a foil, a few papers in~     non-diabetics,non-depressed healthy volunteers showed little to no effectiveness in lowering~     blood sugar levels. Furthermore, one investigator (JLM) has published data showing acute ,~     clinically significant weightgain in serotonergically treated psychiatric inpatients. The~     authors theorize that the use of chromium may reduce carbohydrate craving, appetite and thus~     protect against weight gain side effects.~      Given this pivotal paper in the depressed population, effectiveness data in the diabetes~     population and some possible metabolic ties between these two populations, the author wishes~     to study the effect of chromium piccolinate in mentally ill subjects who are being started on~     serotonergic manipulating medications while in an inpatient treatment setting. These patients~     will be followed during their inpatient stay and then be followed after discharge for a~     single visit to determine acute interventional effects of chromium piccolinate. We feel~     chromium piccolinate is less toxic/hazardous than many of the weght loss medications that we~     currently use and therefore suggest a long term randomized, controlled study where subjects~     will receive active drug (chromium piccolinate) or placebo at the start of any serotonergic~     treatment while inpatient. The chromium piccolinate and the placbo will be obtained from the~     Nutrition 21 company, which has been approved by the FDA as a source of this product.~   "
213907|NCT00759980|"~     Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit.~     Commonly, the decision of when to transfuse platelets is based on platelet number. Recently,~     Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather~     than platelet number. By using platelet size as a guide of when to give platelets, we may be~     able to decrease the amount platelet transfusions needed.~      This study is investigating using platelet size rather than platelet number as a guideline~     for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care~     unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized~     to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a~     combination of platelet number and platelet mass. In each group the decision to transfuse~     platelets will be made using a slightly different, yet strict set of transfusion rules.~      The objective is to determine the feasibility, rate of bleeding complications and compliance~     of transfusing neonates based on platelet mass rather than platelet number.~      The investigators hypothesize that transfusing platelets based on platelet mass will not~     increase bleeding complications and will reduce the number of transfusions in~     thrombocytopenic neonates.~   "
213924|NCT00759759|"~     The objective of this single-dose, open-label, randomized, two-period crossover study was to~     compare the rate of absorption and oral bioavailability of a test formulation of morphine~     sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division~     Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x~     100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered~     after a 10-hour overnight fast.~   "
213925|NCT00759746|"~     The purpose of this study is to determine the effect of dose and content of an enhanced~     weight maintenance treatment on children's ability to maintain weight loss following a~     standard weight loss treatment.~   "
213908|NCT00759967|"~     More than 80% of patients with end stage renal disease have hypertension; 70% of whom are~     poorly controlled using conventional Hemodialysis therapy. An expanded extracellular fluid~     volume and an increase in peripheral vascular resistance as a result of hemodynamic/trophic~     effects of an increased sympathetic nerve activity, angiotensin II, asymmetrical dimethyl~     arginine, and decreased nitric oxide are the most frequently quoted mechanisms contributing~     to hypertension in this population. The intermittent nature of conventional hemodialysis~     treatments (4 hours, 3 days/week) results in the majority of patients having a sustained~     expansion of the extracellular fluid volume that likely contributes to the activation of~     neurohormonal pathways. However, daily therapy including short daily hemodialysis (2 hours, 6~     days/week) and nocturnal hemodialysis (6-8 hours, 5-6 days/week) improve or even normalize~     blood pressure. Short daily hemodialysis appears to improve blood pressure secondary to a~     reduction in extracellular fluid volume (7,8) whereas the improvement in blood pressure with~     nocturnal hemodialysis occurs by a reduction in peripheral vascular resistance (8,9,10). This~     is consistent with the Katzarski et al experience (7-8 hours, 3 days/week) and one randomized~     controlled trial in which blood pressure control was due to normalization of extracellular~     fluid volume in some patients and a reduction in peripheral vascular resistance in others.~     The majority of the studies in daily dialysis are observational, do not include a run-in~     period to optimize blood pressure management and have not explored the mechanisms of~     improvement in blood pressure in detail. We have designed a 9 month study to determine if the~     mechanism by which short daily hemodialysis is associated with an improvement in blood~     pressure control is secondary to changes in sympathetic nervous system activity and/ or~     extracellular fluid volume. Additionally we would like to explore the potential impact of~     short daily dialysis, compared to conventional dialysis, on markers of inflammation and~     oxidative stress in detail.~   "
213909|NCT00759954|"~     The objective of this single-dose, open-label, randomized, two-period crossover study was to~     compare the rate of absorption and oral bioavailability of a test formulation of morphine~     sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division~     Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x~     100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered as~     a sprinkle on applesauce after a 10-hour overnight fast.~   "
213910|NCT00759941|"~     The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day~     to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated~     intraocular pressure.~   "
213911|NCT00759928|"~     Two cohorts of patients will be enrolled: Cohort A will consist of patients who are current~     smokers, and Cohort B will consist of patients who are current nonsmokers. There will be 24~     patients enrolled in each cohort. Nonsmokers are patients who have not consumed tobacco or~     nicotine-containing products for 1 year before the start of the study. Patients classified as~     current smokers must have smoked a minimum of 10 cigarettes per day for up to 1 year.~     Patients who have smoked 1-9 cigarettes per day for up to 1 year, or more than 10 cigarettes~     per day for less than 1 year will not be eligible for this study.~   "
213912|NCT00759915|"~     The objective of this single-dose, open-label, randomized, two-treatment, two-period~     crossover study was to compare the relative bioavailability of a test formulation of KADIAN~     (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the~     commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma~     Branded Products Inc.. Following an overnight fast of at least 10 hours, subjects consumed a~     standard high-calorie, high-fat breakfast meal that began 30 minutes prior to each dose.~   "
213913|NCT00759902|"~     The objective of this single-dose, open-label, randomized, two-treatment, two-period~     crossover study was to compare the relative bioavailability of a test formulation of KADIAN~     (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the~     commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma~     Branded Products Inc. following an overnight fast of at least 10 hours.~   "
213914|NCT00759889|"~     The objective of this study protocol is to use wound biopsies that have been obtained during~     standard of care management for further scientific evaluation after standard evaluation by a~     pathologist. Further imaging and molecular analyses would closely evaluate the presence,~     architecture, and interaction of wound biofilm and human host tissues.~   "
213915|NCT00759876|"~     Duchenne muscular dystrophy (DMD) is a genetic disorder that develops in boys. It is caused~     by a mutation in the gene for dystrophin, a protein that is important for maintaining normal~     muscle structure and function. Loss of dystrophin causes muscle fragility that leads to~     weakness and loss of walking ability during childhood and teenage years. A specific type of~     mutation, called a nonsense (premature stop codon) mutation, is the cause of DMD in~     approximately 10-15% of boys with the disease. Ataluren is an orally delivered,~     investigational drug that has the potential to overcome the effects of the nonsense mutation.~     This study is a Phase 2a extension trial that will evaluate the long-term safety of ataluren~     in boys with nonsense mutation DMD, as determined by adverse events and laboratory~     abnormalities. The study will also assess changes in walking, muscle function, strength, and~     other important clinical and laboratory measures.~   "
213916|NCT00759863|"~     The LifeZig Project is a research study of a new reminiscence activity for individuals with~     Alzheimer's Disease (AD) and other types of dementia, based on the LifeZig system, with~     personalized video channels containing old photographs and music on television.~      The goal of the LifeZig study is to enhance the quality of life for dementia patients and~     their families/caregivers, decrease the burden of care, and contribute to positive~     interaction between dementia patients and families/caregivers.~   "
213917|NCT00759850|"~     Stent implantation is the best treatment in patients with acute myocardial infarction (STEMI)~     referred for primary angioplasty (pPCI). However the occurrence of in stent restenosis is~     responsible for the need of repeat intervention. Both Sirolimus-eluting stents (SES) and~     Paclitaxel-eluting stents (PES) have been proven to virtually abolish in-stent restenosis in~     elective patients in simple e more complex lesions. Both SES and PES have raised concerns~     regarding occurrence of late stent thrombosis, especially in complex lesion subsets or in~     high risk patients. The PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in primary~     angioplasty (PASEO) trial was a prospective, single-center, randomized trial evaluating the~     benefits of SES or PES as compared to BMS implantation in patients undergoing primary~     angioplasty for acute STEMI. From 1 October 2003 we randomized with 1:1:1 ratio, 270 patients~     with STEMI and treated with pPCI, to implantation of a bare metal stent (BMS n=90), PES~     (n=90) or SES (n=90).~   "
213918|NCT00759837|"~     The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and~     tolerability of bosutinib in healthy subjects and subjects with liver disease.~   "
213919|NCT00759824|"~     The primary aim of this study is to determine if the addition of valproic acid to a~     combination of adriamycin, cyclophosphamide and vindesine could increase progression-free~     survival in patients relapsing after first-line chemotherapy including platinum derivatives,~     cisplatin or carboplatin, and etoposide.~   "
213926|NCT00759733|"~     Maternal cardiac disease complicates approximately 2 percent of pregnancies and is the~     leading cause of non-obstetrical maternal death. Evaluating cardiac function and dysfunction~     is a complex process requiring skilled clinicians and technology such as ECG, long-term~     monitoring, and echocardiography. A fast, easily obtained blood test for B-type natriuretic~     peptide (BNP) has been developed that can give evidence for heart muscle stretch and~     dysfunction among adults with suspected congestive heart failure. Preliminary experience~     indicates that ventricular dysfunction among OB patients with a history of heart disease can~     be detected with this serum assay. A prospective cohort design consisting of two groups of~     pregnant patients; one with a history of cardiac disease and one without, will be followed~     over the course of the pregnancies and cardiac function will be measured using~     echocardiography and serum BNP. It is hoped that the blood test for BNP will be a reliable~     way to help evaluate OB patients with suspected abnormal heart function.~   "
213927|NCT00759720|"~     The purpose of this study is to determine the safety and efficacy of TAK-559, once daily~     (QD), combined with glyburide in treating Type 2 Diabetes.~   "
213928|NCT00759707|"~     This study will determine whether or not saphenous vein [arterial] bypass grafts in the leg~     relax in response to increases in blood flow.~   "
213929|NCT00759681|"~     This is a prospective, multi-center randomized, controlled study. The study is designed to~     assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group~     in the open surgical repair of large vessels using synthetic vascular grafts or patches.~   "
213930|NCT00759668|"~     The purpose of the study is:~        -  to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety~          (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series~          of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or~          AcrySof Natural Monofocal (Model SN60AT)~        -  to assess patient satisfaction before and after implant~   "
213931|NCT00759655|"~     This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC))~     in male patients less than 6 years old. Annualized bleeding rates and physician / caregiver~     assessments of responses to treatment will be characterized. FVIII inhibitor levels will be~     assessed throughout the study.~   "
213932|NCT00759642|"~     Hormone receptor positive breast cancer is the most common type of breast cancer, comprising~     70-80% of all breast cancers. Endocrine therapy is the main type of initial treatment for~     patients with your type of breast cancer. Endocrine therapy is treatment that tries to~     remove, or block certain hormones from binding to the cancer cells and thus slow or stop the~     growth of cancer. Although most patients with your type of breast cancer respond initially to~     endocrine therapies, it can lose its effectiveness. New therapies for this type of cancer are~     needed.~   "
213933|NCT00759629|"~     The objective of this international, multicenter, randomized study is to assess whether~     coronary artery stenting is associated with a reduced infarct size in patients with AMI~     presenting between 12 and 48 hours after onset of symptoms compared to medical treatment~     alone~   "
213934|NCT00759616|"~     Prospectively monitor the patients receiving the Oxford Partial knee arthroplasty~   "
213935|NCT00759603|"~     The goal of this clinical research study is to learn if the combination of lenalidomide and~     rituximab can help to control Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic~     Lymphoma (SLL) in patients who have already received therapy. The safety of this drug~     combination will also be studied.~   "
213936|NCT00759590|"~     In this study the investigators aim to compare two common methods to estimate the lung~     recruitment in ALI/ARDS patients.~   "
213937|NCT00759577|"~     This is an open-label single center trial to study improvements in symptom bother and quality~     of life in overactive bladder patients self titrating solifenacin 5mg and 10 mg. The study is~     designed to reflect real world conditions in typical male and female OAB patients presenting~     for treatment.~   "
213938|NCT00759564|"~     This study will evaluate what effect renal dysfunction has on a drug that has an intravenous~     (CP-70,429) and an oral form (PF-03709270).~   "
213939|NCT00759551|"~     The purpose of this study is to determine the safety and efficacy of azilsartan, once daily~     (QD), in subjects with essential hypertension.~   "
213940|NCT00759538|"~     The purpose of this observation study is to evaluate the effects of an early, 3 week lasting~     rehabilitation program, that starts roundabout 4 weeks after lung or combined lung~     transplantation, on physical activity, functional and physical condition (6-min-walk, FEV1,~     ADL-score) and quality of life (SF36) in lung transplant recipients with a different length~     of stay on the waiting list and a different duration of hospitalization in the~     transplantation centre after transplantation.~   "
213941|NCT00759525|"~     The purpose of this study is to figure out how decreasing the activity of 11-beta~     hydroxysteroid dehydrogenase (11-beta HSD) will affect your blood vessel function. 11-beta~     HSD, which is found in the kidneys and blood vessels, is a natural protein that when active~     helps to keep your blood pressure under control.~   "
213942|NCT00759512|"~     This study is to evaluate the efficacy of the Kreiger/Kunz method of Therapeutic Touch on~     function, pain perception and quality of life in persons with Osteoarthritis in the knee.~   "
213943|NCT00759499|"~     Debridement Samples being collected for future or immediate research purposes.~   "
213944|NCT00759486|"~     The goal of this study is to establish a prospective, long-term, comprehensive growth and~     development study of the pediatric craniofacial skeleton following fracture, whose~     recruitment is ongoing.~   "
213945|NCT00759473|"~     The purpose of this study is to explore the use of d-cycloserine (DCS) to facilitate~     extinction of response to cocaine cues in cocaine-dependent individuals, in hopes that it may~     lead to the development of new treatment options for cocaine dependence.~   "
213946|NCT00759460|"~     The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine~     on metabolic parameters and syndrome in patients with schizophrenia.~   "
213978|NCT00759031|"~     Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via~     modified gingival margin plaque index method.~   "
213979|NCT00759018|"~     This protocol allows for the treatment of pediatric patients, male and female, between the~     ages of 2 months and 17 years. Patients must have failed steroid treatment for Grade B-D~     acute GVHD.~   "
213947|NCT00759434|"~     Varicose veins are a common problem, affecting up to a third of the western adult population.~     Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications~     include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is~     known to have a significant negative effect on patient's quality of life (QoL).~      Surgery has been used for many years, but it is known that there is a temporary decline in~     QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged~     recovery in some patients and has the risks of infection, haematoma and nerve injury.~      Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated~     persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at~     34 years.~      26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.~      Newer, less invasive treatments are being developed. It would be advantageous to find a~     treatment that avoided the morbidity of surgery, one that could be performed as a day-case~     procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and~     allow an early return to work. These should be the aims of any new treatment for varicose~     veins.~      Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser~     energy delivered into the vein to obliterate it. The vein therefore need not be tied off~     surgically and stripped out.~      The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery~     and EVLT.~   "
213948|NCT00759421|"~     The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine~     on neurocognitive functioning in patients with schizophrenia.~   "
213949|NCT00759408|"~     The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123,~     an investigational compound which is not approved by the FDA.~   "
213950|NCT00759395|"~     This study will determine if a highly selective enkephalinergic receptor modulator is~     effective in the treatment of anxious major depressive disorder.~   "
213951|NCT00759382|"~     The primary aim of this non interventional study is to assess the independent prognostic role~     on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on~     18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with~     non-metastatic non-small cell lung cancers treated with curative intent, taking into account~     the other conventional prognostic factors (performance status, age, sex, disease stage).~   "
213952|NCT00759369|"~     Autosomal dominant polycystic kidney disease (ADPKD) is the most common single gene disorder~     that is potentially fatal. ADPKD is caused by mutations in either of two genes (PKD1, PKD2).~     Cysts begin to develop primarily in renal collecting tubules in utero and continue to form~     and expand throughout the patient's life. One of the goals of the study is to formulate a~     water prescription for use in clinical trials to determine the effect of sustained water~     diuresis on the progression of ADPKD.~   "
213953|NCT00759356|"~     The objective of this single-dose, open-label, randomized, two-period crossover study was to~     compare the rate of absorption and oral bioavailability of a test formulation of morphine~     sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division~     Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x~     100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered~     under fed conditions.~   "
213954|NCT00759343|"~     Purpose:~      The purpose of the Stone Centre Serum and Urine Bank is to provide researchers with large~     numbers of serum and urine samples from kidney stone patients and controls for study of stone~     disease detection and treatment, and will take into account different genetic backgrounds,~     ages, and other patient factors to provide a broad sample size for the study of stone disease~     The Serum and Urine Bank will undoubtedly be an invaluable tool in the quest to understanding~     urinary stone disease.~      Objective:~      The objective of this research is to identify protein species or other compounds responsible~     for or contributing to kidney stone initiation and propagation.~   "
213955|NCT00759330|"~     The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen~     tape for chronic low back pain (lasting greater than 3 months).~   "
213956|NCT00759317|"~     Study Objectives:~        -  to identify neurophysiologic effects of venlafaxine treatment in normal controls using~          quantitative EEG (QEEG) cordance~        -  to examine the effects of venlafaxine on different rating scales measuring mood and~          anxiety (e.g., Ham-D, BDI, SCL-90, POMS-BI, Visual Analog Mood Scale, SSRS, SASS,~          Q-LES-Q and SF-36) as well as on measures of cognitive and psychosocial function (i.e.,~          Stroop, PASAT, RAVLT, Trailmaking A and B, Digit-Symbol, Grooved Pegboard,~          Multidimensional Health Locus of Control, Temperament and Character Inventory,~          Interpersonal Support Evaluation List, Godin Leisure-Time Questionnaire, and Pittsburgh~          Sleep Quality Index) in normal control subjects, and the association of changes in~          cordance with changes in thinking and memory.~        -  to identify physiologic effects of venlafaxine treatment in normal controls using heart~          rate and immune function measures~   "
213957|NCT00759304|"~     The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which~     permanently feed information back to this global biological vigilance system controlling~     allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one~     of the best indicators of ANS activity.~      Low ANS activity level is associated with severe cardiac and cerebral events, as well as to~     death from any cause in the general population.~      This PROOF study was hence designed to evaluate ANS activity levels among a healthy retired~     population, but should these levels decline overtime, to use this as a predictor of~     cardiovascular and cerebrovascular events, taking into account established cardiovascular~     risk factors.~   "
213958|NCT00759291|"~     This study will test the hypothesis that reducing the release of free fatty acids (FFA) from~     fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with~     the metabolic syndrome.~   "
213959|NCT00759278|"~     This is a prospective case-control study to evaluate women who are pregnant and take~     antihypertensive medication for fetal hemodynamics (middle cerebral artery peak systolic flow~     and umbilical artery Doppler systolic to diastolic ratio) compared to a control group of~     pregnant women not taking these kinds of medications. The hypothesis is that the~     investigators expect to observe little to no difference in the comparison between the~     medication group and the control group.~   "
213980|NCT00759005|"~     The purpose of this study is to determine whether cortisol and propranolol are effective in~     the modulation of stress induced heroin-related retrieval enhancement.~   "
213960|NCT00759265|"~     Impaired mobility is a major health problem affecting many subjects with diabetes mellitus.~     It is associated with loss of quality of life and it is a strong predictor for poor health~     outcomes. Reduced lower extremity muscle function, as a consequence of diabetic~     polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of~     resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and~     will improve mobility and associated quality of life.~      The objective of this study is to develop a resistance training intervention that improves~     mobility and quality of life in diabetic patients. It is also our intension to achieve a~     better understanding of the relation between diabetic neuropathy and muscle weakness, limited~     mobility and quality of life. Moreover, insight will be gained in optimizing training~     programmes for neuropathic patients.~   "
213961|NCT00759252|"~     The purpose of this study is to conduct a cross-sectional survey of primary care patients to~     better understand their perceptions of the risks and benefits of a screen and subsequent~     diagnostic confirmation of dementia.~   "
213962|NCT00759239|"~     The purpose of this study is to assess the IOP-lowering efficacy of a combination of~     Travoprost / Timolol maleate, dosed in the morning or in the evening, in patients with~     open-angle glaucoma or ocular hypertension, who have an insufficiently controlled IOP (mmHg),~     and are using prostaglandin analogue monotherapy.~   "
213963|NCT00759226|"~     This multicenter open labeled phase 2 trial examines the efficacy of a combination of~     Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min)~     and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal~     cancer. The combination was considered to be suitable for further evaluation with a freedom~     of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate~     of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable~     patients were needed based on a 2-Stage Simon design with a first evaluation after 25~     evaluable patients.~   "
213964|NCT00759213|"~     It is well established within pediatric and neonatal medicine that social and traditionally~     non-medical aspects of the home environment and conditions after discharge influence~     neonatal health both in the acute and long-term setting. Government programs and laws exist~     that are designed for the provision of basic pediatric health needs. Unfortunately, deficits~     in obtaining those services lead to preventable poor health outcomes. Hospital social workers~     and discharge planners are able to identify appropriate services, while lawyers are experts~     in ensuring those rights and services are actually obtained and delivered.~      West Side Health of CCHS has implemented a medical-legal partnership along the pathways~     advocated by the Medical Legal Partnership for Children as part of their clinical care~     services. Before implementing a similar system in the NICU, a needs assessment will be~     performed first.~      The purpose of this study is to determine what the health care team (physicians, nurses,~     social workers, discharge planners, etc) through our discharge planning practice establishes~     as the legal needs. We will collect information which is normally collected by the health~     care team as a part of their usual care and assessment for discharge planning. The families~     will not be approached directly by study staff.~   "
213965|NCT00759200|"~     This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2~     or 3 chronic hepatitis~   "
213966|NCT00759187|"~     The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of~     commercial oral care products.~   "
213967|NCT00759174|"~     The objective of this non-interventional study is to examine whether use of Phosphodiesterase~     Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset~     of acute NAION.~   "
213968|NCT00759161|"~     The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%,~     compared to Ointment Vehicle in the treatment of plaque type psoriasis.~   "
213969|NCT00759148|"~     The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF~     Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial~     conjunctivitis in patients one month of age or older.~   "
213970|NCT00759135|"~     This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the~     treatment of BPH (benign prostatic hyperplasia) versus finasteride.~   "
213971|NCT00759122|"~     There are two specific aims of this project:~        1. To identify physiologic indicators of venlafaxine treatment response using quantitative~          EEG (QEEG) cordance, and to determine if cordance changes are specifically associated~          with response to venlafaxine~        2. To identify predictors of placebo response in major depression using QEEG~          cordance/bispectral index (BIS) and neuropsychological testing~   "
213972|NCT00759109|"~     This study aims to compare the role of peginterferon α-2b (50 μg/week) vs. control (no~     treatment) in the prevention of hepatocellular carcinoma, in adult patients with cirrhosis~     and initial signs of portal hypertension who did not respond to previous combined therapy~     with interferon alfa + ribavirin or peginterferon alfa + ribavirin or to interferon alfa~     monotherapy and with a high proliferation rate before entering the study. The duration of~     treatment will be 3 years, and the follow-up period will be 2 years.~   "
213973|NCT00759096|"~     The purpose of this study is to assess uniocular and binocular unaided distance,~     intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare~     testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant~     of the Restor IOL.~   "
213974|NCT00759083|"~     To monitor the frequency of the development of thrombocytopenia in patients with Heparin~     Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome receiving~     bivalirudin during Percutaneous Coronary Intervention~   "
213975|NCT00759070|"~     This study is an open-label, randomized, pilot comparison of the effects of either~     lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on~     cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV~     patients after 48 weeks.~   "
213976|NCT00759057|"~     This non-inferiority study will compare the clinical outcomes of subjects implanted with the~     Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented~     posterior lateral spinal fusion.~   "
213977|NCT00759044|"~     To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human~     Blood-Retinal Barrier (BRB) function, in the clinical practice.~   "
213981|NCT00758992|"~     These studies are designed to evaluate the relative efficiency of gene transfer into~     primitive human hematopoietic cells by comparing lentiviral and foamy virus vectors as~     vehicles for transfer and expression of globin genes. Normal volunteers will serve as~     research participants. Each will receive a 4 day course of Granulocyte-Colony Stimulating~     Factor (G-CSF) after which a peripheral blood apheresis will be performed to recover a~     mononuclear cell population enriched in primitive hematopoietic cells. The stem and~     progenitor cells will be purified by selection based on expression of the CD34 antigen. The~     CD34+ population will be cultured in vitro with various cytokines and transduced with vector~     particles. The efficiency of gene transfer will be evaluated in the transduced CD34+~     population, in progenitors contained within that population by culture in semisolid media and~     in cells capable of establishing human hematopoiesis in immunodeficient mice. The level of~     transgene expression will be evaluated in mature hematopoietic lineages that develop in vitro~     or in immunodeficient mice.~   "
213982|NCT00758966|"~     The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine~     is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either~     fluoxetine alone or naltrexone SR alone.~   "
213983|NCT00758953|"~     This study will evaluate the efficacy and safety of an investigational medication compared~     with placebo in the treatment of pain associated with endometriosis.~   "
213984|NCT00758940|"~     An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are~     at least 30 patients or as much as possible from the doctor's clinical practice perspective.~     6 months follow-up after IOL implant in the 2nd eye~   "
213985|NCT00758927|"~     The purpose of this study is to verify the possible effects of OMACOR(omega-3 fatty acid) on~     the percentage change of small dense LDL fraction in type 2 diabetic patients with combined~     hyperlipidemia, we perform open-label prospective randomized multi-institutional phase IV~     study.~   "
213986|NCT00758914|"~     Aging is associated with a variety of changes in the immune system. These changes result in a~     less effective immune response, which places the elderly at a greater risk for infection and~     disease. Respiratory infections cause a great number of morbidity and mortality in the~     elderly population. Vitamin E has been known to improve the immune response of the elderly~     and has been suggested for use in preventative strategies for this population. The purpose of~     this study is to examine the effect of one year vitamin supplementation on respiratory~     infection in the elderly population residing in nursing homes. This study was conducted using~     a randomized, double blind, placebo controlled clinical trial at 33 long-term care facilities~     in the greater Boston area. A total of 617 subjects over the age of 65 were enrolled in the~     study, with 451 completers. The participants were supplemented wit either 200 IU of vitamin E~     per day or placebo. The primary outcomes consisted of respiratory tract infection, number of~     sick days, and antibiotic use. The study involved use of questionnaires, standard~     anthropometrics measurements, non-invasive body composition, blood and urine sample~     collection, and delayed type test (DTH) using the Mantoux method. This study has been closed~     since August 2000 and is in the stage of data analysis only.~   "
213987|NCT00758901|"~     This observational study intends to collect efficacy and safety data on ROCC Knee system.~   "
213988|NCT00758888|"~     A few studies concerning the effects of joint manipulation have shown muscle responses distal~     to the site of manipulation. The purpose of this study is to determine if pelvic orthopedic~     blocking, a low force method of manipulating the sacroiliac joint, can have produce changes~     to cervical spine function.~   "
213989|NCT00758862|"~     A national, prospective single arm phase II study investigating the pharmacokinetics and~     safety of the 2% TD1414 cream when applied 3 times daily for 7 days to adult patients with~     impetigo or Secondarily Infected Traumatic Lesions (SITL). A total of 20 patients will be~     enrolled.~   "
213990|NCT00758849|"~     The purpose of this study is to determine whether Fipamezole is effective in the treatment of~     orthostatic hypotension and related symptoms in multiple system atrophy and Parkinson's~     disease.~   "
213991|NCT00758836|"~     This study will test the safety and how effective telcagepant is when taken with ibuprofen or~     acetaminophen in participants with migraine with or without aura. The primary study~     hypothesis is that at least one drug combination is superior to telecagepant alone in the~     treatment of acute migraines.~   "
213992|NCT00758823|"~     THe main goal of our randomized controlled trial with blinded observer will be to compare~     four pediculicide products acting mechanically, Paranix Spray, Paranix Lotion, Paranix Mousse~     and Hedrin against a reference product acting chemically, Prioderm, during a non-inferiority~     (20% equivalence). THe randomization will be balanced every 10 families. The secondary~     objective will be to compare the lenticide efficacy of the products and their local tolerance~     and cosmetic acceptibility.~   "
213993|NCT00758810|"~     In secondary prevention, the beneficial role of cardiac rehabilitation programs after~     myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now~     well established. The large majority of patients don't benefit from cardiac rehabilitation~     but for those who do, they usually follow an inhospital short health educational program with~     a sensibilisation to different coronary risk factors like smoking, overweight and inactivity.~     The impact of these inhospital short health educational programs combined to cardiac~     rehabilitation has never been totally evaluated, especially the impact on smoking cessation,~     weight loss and daily physical activity.~      Therefore, the present study aims to evaluate the impact at one year on 400 consecutive~     patients' coronary risk profile of:~        -  an inhospital short health educational program alone~        -  an inhospital short health educational program combined to cardiac rehabilitation~        -  a cardiac rehabilitation program alone~   "
213994|NCT00758797|"~     A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating~     cream.~   "
213995|NCT00758784|"~     The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution~     in dry eye disease.~   "
213996|NCT00758771|"~     The purpose of this study is to characterize the rheological properties of cystic fibrosis~     (CF) and healthy sputum and to examine the effects of mucoactive agents on the rheology of CF~     and healthy sputum. By collaborating with Genentech, the investigators (scientists at UCSF)~     plan to incorporate the latest scientific findings into our work to discover and develop new~     treatments for CF.~   "
213997|NCT00758758|"~     The objective of this clinical investigation is to compare patients treated with Anterior~     Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a~     concurrent, randomized, control group receiving autologous iliac crest bone graft or~     allograft and test the hypothesis that ACDF with Hedrocel is non-inferior to ACDF with~     allograft or autologous bone graft.~   "
213998|NCT00758745|"~     Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece~     (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber~     Opacifiation (PCO).~   "
213999|NCT00758732|"~     This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal~     doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment~     free-interval of at least six months~   "
214000|NCT00758719|"~     The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion~     System in patients undergoing lumbar fusion surgery.~   "
214001|NCT00758706|"~     The primary aim of this study is to investigate the effects of AZD1236 compared with placebo~     (inactive substance) in COPD patients by analysing biomarkers for inflammation and tissue~     degradation in blood, urine and sputum.~   "
214002|NCT00758693|"~     Many chemotherapy combinations may be used to treat patients with chronic lymphocytic~     leukemia (CLL). Although there are many options, a single, best option is not agreed upon by~     most cancer specialists. Bendamustine, a medicine recently approved for use in the United~     States, has been used in combination with rituximab in previous studies to treat patients~     whose CLL has returned after previous standard treatments. The purpose of this study is to~     determine whether bendamustine with rituximab is effective for the initial treatment of CLL~     for patients aged 65 and older.~   "
214003|NCT00758680|"~     This study will asses the safety, tolerability, multiple-dose pharmacokinetics and~     pharmacodynamics of MK1006 in participants with type 2 diabetes.~   "
214004|NCT00758667|"~     The purpose of this study is to make available an agent,Mesna, which can assist the surgeon~     during the procedure of capsulectomy.~   "
214005|NCT00758654|"~     The purpose of this study is to compare the diagnostic value of SENC to that provided by~     conventional wall motion analysis for the detection of inducible ischemia during~     DS-MRI.High-dose dobutamine stress magnetic resonance imaging (DS-MRI) is safe and feasible~     for the diagnosis of coronary artery disease (CAD) in humans. However, the assessment of cine~     scans relies on the visual interpretation of regional wall motion, which is subjective.~     Recently, Strain-Encoded MRI (SENC) has been proposed for the direct color-coded~     visualization of myocardial strain.~   "
214006|NCT00758641|"~     Rationale: The standard treatment of chronic plantar fasciitis is corticosteroid injections.~     Corticosteroid injection give temporarily pain reduction, but no healing. Blood platelets~     initiate the natural healing rate. GPS ® gives an eightfold concentrate platelets of patients~     own blood. Injection of these platelets in the tendon might induce a healing rate.~      Objective: To compare the efficacy of autologous platelet concentrate injections with~     corticosteroid injection in patients suffering from plantar fasciitis with respect to pain~     and function.~   "
214007|NCT00758628|"~     : The objective of this study is to determine if bromfenac reduces diabetic macular edema~     (DME) as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the~     working-aged population in the United States. 60% of patients with Type-II DM, and nearly all~     with Type-I DM progress to Diabetic Retinopathy (DR) in twenty years. Diabetic Macular Edema~     is the principal cause of vision loss in DR. Approximately 50% of patients with DME will~     experience a loss of >=2 lines of best-corrected visualacuity (VA) after 2 years of~     follow-up. The pathogenesis of DME is multifactorial and complex, but intervention stratagem~     have tended to be singular. Photocoagulation laser applied directly to leaking microaneurysms~     and a grid of laser has been the mainstays of treatment since the publication of the Early~     Treatment Diabetic Retinopathy Study (ETDRS). This landmark clinical trial was an NIH~     sponsored, multicenter, controlled study that demonstrated efficacy of laser for diabetic~     macular edema. It also demonstrated that 20% of patients did not respond. Recent efforts to~     improve the results are focusing on pharmaceutical interventions injected into the vitreous~     cavity. The route of administration and lack of substantiated efficacy are problematic.~   "
214008|NCT00758615|"~     Walking to school is one of the objectives for children and adolescents in Healthy People~     2010 and in previous studies was associated with higher levels of overall physical activity,~     which has been shown to decrease obesity. Therefore, more children walking to school should~     result in increased physical activity and presumably reduce obesity. However, increasing~     child pedestrian activity could increase the risk of child pedestrian injuries. Walking with~     an adult who provides instruction in pedestrian skills and monitors the child's actual~     behavior may be the most important component of a successful intervention. Walking with an~     adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB)~     addresses safety concerns by providing a period of physical activity supervised by several~     responsible adults and teaching opportunities around pedestrian safety skills on the way to~     and from school. Children may join the WSB at various points along the set route. Despite the~     growing popularity of WSB programs in the United States, randomized, controlled-studies are~     lacking that examine the impact on children's safety, physical activity, and health. We seek~     to help fill this gap in the literature by piloting a WSB program in elementary schools in~     the Houston Independent School District to test feasibility. We hypothesize that a WSB~     program will: (1) increase the number of students walking to school and decrease the number~     of students driven to school by car, (2) increase students' pedestrian safety behaviors (3)~     increase students' physical activity, and (4) decrease students' excess weight gain.~   "
214009|NCT00758602|"~     This 2 arm study will compare the efficacy and safety of CellCept, combined with low or~     standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients~     will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid +~     tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or~     2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3~     followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study~     treatment is 1 year, and the target sample size is 100-500 individuals.~   "
214010|NCT00758589|"~     The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled~     asthmatic patients on maintenance inhaled glucocorticosteroids.~   "
214015|NCT00758524|"~     This study is a proof-of-efficacy, dose finding study of LCI699 in patients with~     mild-to-moderate uncomplicated essential hypertension in order to assess the BP lowering~     effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.~   "
214016|NCT00758511|"~     Switzerland is having one of the highest premature rates in Europa and most of the preterm~     neonates need neonatal intensive care. Up to 80% of the analgesic used in neonatal intensive~     care units are either off label used or non-licensed used. As an alternative approach~     non-pharmacological interventions for pain prevention and relief are increasingly being~     recommended for the prevention and treatment of mild and moderate pain in this population.~      This multicenter pilot study will use a randomized three group,repeated measures design.~      The primary aims of this study of premature neonates are to:~      1.) Estimate effect sizes for the impact of the proposed interventions(facilitated tucking~     alone, sucrose alone and sucrose in combination with tucking)on pain reactivity.~      2.) Examine the impact of gestational age on the estimates of efficacy 3.) Examine the impact~     of the numbers of painful procedures the infant experiences and the concurrent use of~     analgesic medications on the estimates of efficacy~   "
214017|NCT00758498|"~     This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil~     and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag~     disorder.~   "
214018|NCT00758485|"~     The current trial was designed to demonstrate faster recovery in participants undergoing~     elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a~     fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of~     neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex~     compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the~     Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these~     participants.~   "
214019|NCT00758472|"~     Prospective data collection on survivorship of ReCap Total Hip Resurfacing~   "
214020|NCT00758459|"~     The primary aim of this study is to investigate the tolerability and safety of AZD 1236~     compared with placebo (inactive substance) in COPD patients by assessment of Adverse~     Events, vital signs and laboratory safety assessments.~   "
214021|NCT00758446|"~     This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare~     the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge~     model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety~     profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.~      The aim of this study is to compare the effect, safety and tolerability of 14 days treatment~     with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.~   "
214022|NCT00758433|"~     To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and~     0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess~     the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug~     from civamide patch in a subset of study subjects.~   "
214023|NCT00758420|"~     The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in~     the relief of symptoms, improvement of appearance, and overall effectiveness and safety in~     the treatment of varicose veins compared to placebo.~   "
214024|NCT00758407|"~     The purpose of this randomized controlled clinical trial is to investigate the efficacy and~     safety of methylphenidate in patients with fatigue caused by cancer.~   "
214025|NCT00758394|"~     This clinical study was to evaluate the control of dental plaque formation after~     toothbrushing for 4 days with each of the 4 study toothpastes.~   "
214026|NCT00758381|"~     This is multicentre, open-label, randomized, phase II trial in patients with locally advanced~     or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive~     gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone~     (arm B), as first-line chemotherapy.~   "
214027|NCT00758368|"~     The purpose of this study is to compare the effects of apomorphine, given by two different~     methods, to determine how best to manage dyskinesias.~   "
214028|NCT00758355|"~     Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.~   "
214029|NCT00758342|"~     To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0%~     (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004%~     (Travatan) once daily. The study is double masked. The patients will receive either treatment~     for 12 weeks.~   "
214030|NCT00758329|"~     Retrospective Data Review on clinical outcomes and survivorship of ReCap Total Hip~     Resurfacing~   "
214031|NCT00758316|"~     Background:~      Malignant pleural effusions form a significant proportion of respiratory and oncology~     work-load. The efficacy of thoracoscopic talc poudrage which is the current standard of care~     is limited by lung entrapment which prevents lung re-expansion. Thoracoscopy patients also~     have significant hospital length of stay because chest tube drainage must continue until the~     pleural space is dry to effect successful pleurodesis.~      Alternative management strategies such as tunnelled pleural catheters (bedside~     ultrasound-guided) enable outpatient management of pleural effusions but have limited~     pleurodesis rates and do not offer any chance of getting pleural biopsies.~      A prospective randomized controlled trial with two arms i.e. thoracoscopic poudrage alone~     (standard care) versus combined thoracoscopic poudrage and tunnelled pleural catheters. The~     tunnelled catheters will be inserted at the time of thoracoscopy in the endoscopy centre~     under ultrasound guidance. The trial is aimed to be completed within 3 years. Primary~     end-points will be pleurodesis success. The secondary end-points are hospital length-of-stay,~     complication rates, analgesia requirements, pain scores and quality-of-life scores. Based on~     power calculations, we aim to recruit 120 patients in each arm.~   "
214032|NCT00758303|"~     The purpose of this study is to determine the effectiveness and safety of TRIA-662 (also~     known as 1-MNA) in treating elevated triglyceride levels in patients not receiving lipid~     lowering treatment. This study will determine the effects of TRIA-662 on commonly measured~     blood fats that are known to be important in the prevention of vascular disease.~   "
214033|NCT00758290|"~     Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3~     week brushing regiment.~   "
214034|NCT00758277|"~     Prospective randomized double blind controlled trial in prevention of relapse in recently~     detoxified alcohol dependent patients with levetiracetam and placebo.~   "
214035|NCT00758264|"~     The purpose of this study is to demonstrate, in 12-23 months old subjects, the~     non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when~     co-administered, compared to each vaccine administered individually.~   "
214036|NCT00758251|"~     The purpose of this study is to assess severity of illness in schizophrenia patients in~     routine clinical practice at the time of entry in the study and after the treatment with~     Seroquel XR for 8 weeks.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
214037|NCT00758238|"~     The project includes a systematic review to inform refinement of intervention components and~     a pilot RCT to determine the uptake, feasibility, and potential value of a hypertension~     self-management strategy using personal health records. The review follows generally~     acceptable systematic review and/or meta-analytic techniques; with specific attention devoted~     towards accessing information and effectiveness data from unpublished studies or reports~     within grey literature and contacting individuals with expertise in chronic disease~     management in primary care. Findings of the review will be used to expand/modify an existing~     intervention 'template' to yield an evidence-based strategy with potential to enhance~     self-management of hypertension in primary care. The pilot RCT will assess the utility of the~     multifaceted intervention, delivered in part via a secure patient-controlled personal~     electronic health record, compared with the usual family practice management, for patients~     with undiagnosed or uncontrolled elevated blood pressure. Patients who are hypertensive or~     identified as high risk are expected to benefit from the increased flexibility and autonomy~     of out-of-physician-office self-monitoring with self-management support. This initial~     evaluation will focus on the change in hypertension knowledge, patient self-efficacy, and~     patient engagement in self management activities after 3 months, in the intervention group~     compared to the control group; the feasibility and acceptability of the intervention to~     patients and providers; and the processes involved in linking the patient self-management~     experience back to the patient's health care providers to promote coordination of care.~     Secondary outcomes include change in blood pressure, number and content of interactions with~     providers, and changes in management, including antihypertensive medication.~   "
214038|NCT00758225|"~     The scientific aim of the present extension study is to monitor long-term safety and~     tolerability of idebenone in patients with DMD. Furthermore, the long-term effect on~     respiratory, cardiac and motor functions, and skeletal muscle strength/function will be~     assessed.~   "
214039|NCT00758212|"~     Influenza vaccination has proved it's effectiveness over many years of usage including~     HIV/AIDS patients who are immunocompromised. In those patients, however, a noted rise in HIV~     viral load which follows intramuscular injection of the vaccine is of unknown significance~     over the long run. Mesotherapy is a procedure developed and practiced in france by which a~     reduced and diluted amounts of antigens is being introduced by multiple intradermal~     injections over the torso and upper back. Mesotherapy is mainly used as a vehicle for~     introducing pain medicine and cosmetics.~   "
214040|NCT00758199|"~     The objective of this study is to determine if an extension of bromfenac BID monotherapy is~     effective in the decreasing retinal thickening post cataract IOL placement surgery. No~     studies exist on how long to treat with an NSAID post cataract IOL placement surgery.~     Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment,~     lasting approximately 3 weeks. This study is designed to examine if there is benefit to~     extending NSAID monotherapy in regards to macular thickening and the incidence of CME.~   "
214041|NCT00758186|"~     The objective of this randomized controlled trial was to evaluate the role colonic~     self-expanding metal stent (SEMS) placement as a bridge to surgery in patients with acute~     malignant left-sided colonic obstruction. The study was designed to test the hypothesis that~     SEMS placement could be effectively and safely used in this group of patients to relieve~     colonic obstruction thereby allowing safe recovery and medical stabilization before~     proceeding to elective surgery~   "
214042|NCT00758173|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This study is looking at genetic susceptibility and the interactions between genes~     and the environment in patients with prostate cancer.~   "
214043|NCT00758160|"~     The purpose of this study is to evaluate whether familial relationships and psychological~     status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder~     (ADHD) symptoms of participants can be improved by switching from Immediate-release~     Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).~   "
214044|NCT00758147|"~     The purpose of this study is to assess the influence of force feedback joysticks and haptic~     feedback in improving upper limb rehabilitation outcomes following stroke.~   "
214045|NCT00758134|"~     This is a prospective study assessing efficacy of trastuzumab therapy in pretreated NSCLC~     patients. Patients with locally advanced or metastatic NSCLC, HER2 FISH positive and/or with~     HER2 gene mutation, pretreated with at least one previous chemotherapy line will be~     considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and~     after signature of informed consensus form, all eligible patients will receive trastuzumab 6~     mg/kg every 3 weeks (8 mg/kg loading dose) until disease progression, unacceptable toxicity~     or patient refusal.~   "
214046|NCT00758121|"~     The objective of the study is to determine if there is any relationship between respiratory~     rate and Heart Failure events.~   "
214047|NCT00758108|"~     This study will explore conditions caused by the absence of certain genes on chromosome 11.~     These conditions include WAGR syndrome, which is characterized by a kidney tumor called Wilm~     s tumor, aniridia (absence of the iris of the eye), genital and urinary abnormalities, mental~     retardation, and possibly other symptoms. This study will examine how the genes on chromosome~     11 affect people and whether the absence of specific genes is associated with specific~     symptoms.~      Healthy normal volunteers, people with isolated aniridia, and people with WAGR or another~     chromosome 11 gene deletion may be eligible for this study. Participants must be at least 6~     years old. Parents of patients may also participate for genetic studies.~      Participants undergo some or all of the following procedures, depending on whether they are a~     child, adult, healthy volunteer or parent of a patient:~        -  Medical history and physical examination, eye examination, blood, urine and saliva~          tests, electrocardiogram (EKG) and electroencephalogram (EEG)~        -  X-rays, scans and other tests to measure body composition (fat, muscle and bone~          development and thickness) and MRI to examine the eyes and the brain and to measure~          abdominal fat~        -  Ultrasound studies of the kidneys, ovaries and uterus (in females) and testes (in males)~        -  Meal tests, food diaries and food preference tests~        -  Questionnaires about eating and sleep habits, personality and character traits and~          responses to pain and injury~        -  Neuropsychological tests~        -  Tests of resting metabolic rate, energy expenditure and glucose (sugar) tolerance~        -  Hot and cold sensitivity tests, vibration sensitivity test, cold tolerance test and~          smell identification test~        -  Eye and hearing tests~        -  Nerve conduction studies and study of sensory information conduction from peripheral~          nerves to the spinal cord and brain~        -  Computer photography~        -  Evaluation by sub-specialists (e.g., endocrinologist, ophthalmologist, physiatrist,~          neurologist or others) as indicated by the patient s medical history and test results~   "
214111|NCT00757250|"~     The purpose of this study is to test the safety of an investigational medication, TXA127, and~     its ability to increase T-lymphocyte counts, specifically CD4+ T-lymphocytes, in persons~     infected with human immunodeficiency virus who are taking highly active anti-retroviral~     therapy.~   "
214048|NCT00758082|"~     TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients~     that have attended a functional insulin therapy training course. The Primary objective of the~     TELFIT study is to evaluate whether a PDA with telemonitoring by phone reinforces the effects~     of the functional insulin therapy training course as compared with conventional care.~      Main judgment criteria: comparison of HbA1c means between M0 (start) and M3(3 months)~   "
214049|NCT00758069|"~     A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with~     Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy~   "
214050|NCT00758056|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between~     genes and the environment in patients with endometrial cancer.~   "
214051|NCT00758043|"~     This study is being conducted to learn more about the safety and effect of telaprevir in~     combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with~     hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is~     designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who~     respond quickly to a telaprevir-based treatment.~   "
214052|NCT00758030|"~     The purpose of the study was to evaluate and compare the pharmacokinetics of ER OROS~     paliperidone in healthy Japanese and Caucasian patients.~   "
214053|NCT00758017|"~     The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with~     chronic low back pain and to compare 2 different groups of patients which differ in the~     acupuncture method used to treat the pain.~   "
214054|NCT00758004|"~     To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing~     to the 80 mg commercial atorvastatin calcium tablet formulation.~   "
214055|NCT00757991|"~     RATIONALE: Studying samples of blood from healthy volunteers in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between~     genes and the environment in healthy volunteers.~   "
214056|NCT00757978|"~     Memantine as an add-on therapy to clozapine may improve schizophrenia negative symptoms and~     cognitive functioning.~   "
214057|NCT00757965|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between~     genes and the environment in patients with colorectal cancer.~   "
214058|NCT00757952|"~     RATIONALE: Studying samples of exhaled breath from patients with ovarian epithelial cancer,~     polycystic ovarian syndrome, or endometriosis and from healthy participants in the laboratory~     may help doctors identify and learn more about biomarkers related to cancer. It may also help~     doctors find and diagnose ovarian epithelial cancer sooner, when it may be easier to treat.~      PURPOSE: This clinical trial is studying exhaled breath biomarkers to see how well they find~     ovarian epithelial cancer in patients with newly diagnosed ovarian epithelial cancer,~     polycystic ovarian syndrome, or endometriosis and in healthy participants.~   "
214059|NCT00757939|"~     The aim of the study is to determine if regional cerebral blood flow, measured by dynamic~     arterial spin labeling (dASL), can be a biomarker for stage of Alzheimer's disease. The study~     is designed to be conducted in 2 parts in participants with mild to moderate Alzheimer's~     disease, and participants with normal cognition. Various imaging studies will be done using~     magnetic resonance imaging (MRI) and positron emission tomography (PET) along with~     neurocognitive assessments. Participants who meet the study-entry criteria will have up to 8~     study visits. Repeat imaging studies may be required if the initial data are incomplete or~     un-interpretable. The maximum number of PET scans during the study will be limited to four.~   "
214060|NCT00757926|"~     A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate~     the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated~     Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to~     healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to~     evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes~     G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16~     weeks of age concurrently with other standard EPI vaccines would be generally well tolerated~     and immunogenic.~   "
214061|NCT00757913|"~     Background: Delirium and long-term cognitive dysfunction (CD) are important complications of~     major surgery and intensive care treatment. Delirium is associated with increased mortality~     and CD has an important impact on mortality, independency, social interactions, and quality~     of life. Delirium is an important risk factor for the development of long-term CD.~     Particularly, patients aged 65 or older undergoing cardiac surgery are at a high risk of~     developing these problems. There are data suggesting that inflammation plays a key role in~     the development of delirium and possibly CD. It has been shown that n-3 fatty acids modulate~     the immune response of patients and have beneficial effects in abdominal surgery.~      Working hypothesis: 1. Administration of n-3 enriched nutrition therapy including will~     modulate the inflammatory response and improve cognitive function after cardiac surgery.~      Specific Aims: This project will test the impact of perioperative enteral n-3 fatty acids~     ProSure, Abbott Nutrition) in elderly patients undergoing elective cardiac surgery. Primary~     endpoint is CD one week postoperatively.~      Methods: The investigators will investigate 400 patients aged 65 or older undergoing elective~     cardiac surgery. Half of these patients will receive supplementary of n-3 fatty acids to~     modulate the inflammatory response; the other half will receive an isocaloric nutritional~     supplement without n-3 fatty acids (Ensure Plus, Abbott Nutrition). Otherwise the treatment~     of the patients will not be influenced by this study. Cognitive function will be assessed~     preoperatively, 7 days and three months postoperatively. C-reactive protein, IL-6, IL-8,~     IL-10, S-100B, and neuron specific enolase will be monitored as markers of systemic~     inflammation and delirium.~   "
214112|NCT00757237|"~     The purpose of this study was to assess the comparative safety and effectiveness of aztreonam~     for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients~     with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.~   "
214062|NCT00757900|"~     Vaccination of HIV infected individuals with the sub-unit influenza vaccine is safe; however~     it induces only moderate immune responses and likewise is modest in its protection compared~     to HIV uninfected individuals. Based upon the available data, the South African Thoracic~     Society has provisionally recommended the use of influenza vaccine in HIV infected~     individuals with CD4+ counts of > 200/ml and viral loads of < 100 000 copies/ml.(Green R et~     al. In press, SAMJ). This proposal is however based upon recommendations made elsewhere with~     minimal level of evidence regarding its benefit, and no evidence from countries with a high~     prevalence of HIV. Very few HIV infected adults, however, actually do receive influenza~     vaccine in South Africa, partly because of the absence of compelling data regarding the~     burden of disease in Africa as well as lack of vaccine effectiveness and issues related to~     physician awareness and access to influenza vaccine in the public immunization program.~      The conflicting evidence, between developed countries and Africa, regarding the effectiveness~     of PPV highlight the drawbacks of extrapolating vaccine effectiveness data from developed~     countries to developing countries. Differences in the epidemiology of HIV between developed~     countries in which the prevalence of HIV is low to that of high-burden sub-Saharan African~     countries include:~        -  differences in the mode of transmission of HIV and demographics of the infected~          population.~        -  differences in standard of care, including access to prophylaxis against opportunistic~          infections and use of highly active anti-retroviral therapy (HAART)~        -  differences in risk for disease from opportunistic pathogens, e.g. Mycobacterium~          tuberculosis, etc.~      These differences may all contribute to differences in the risk and severity of influenza~     illness among HIV infected adults from these communities as well as possibly responsiveness~     and effectiveness of vaccination.~      The investigators are conducting a double-blinded, placebo controlled randomized trial at the~     HIV treatment clinic at Helen Joseph Hospital to determine the effectiveness of influenza~     vaccination in HIV infected adults in South Africa. The significance of the findings from~     this study will help quantify the burden of influenza illness in African HIV infected adults,~     as well as assist in making more informed recommendations for the use of influenza vaccine in~     HIV infected adults and in guiding national policy for preparing for a future influenza~     virus-pandemic.~   "
214063|NCT00757887|"~     In the EHMI-8 study (CMO 2006/207) the investigators induced sterile protection against P.~     falciparum challenge in healthy Dutch volunteers by repeated exposure to infected mosquitoes~     whilst under chloroquine prophylaxis. The surprisingly efficient induction of protection in~     this study strongly supports the development of whole parasite vaccines and is therefore an~     important finding to malaria vaccine development. In this study (EHMI8B) the investigators~     would like to explore the longevity of the protective immune response and simultaneously~     further characterise immune mechanisms responsible for protection by re-exposing EHMI-8~     volunteers to infected mosquito bites.~   "
214064|NCT00757874|"~     Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of~     persons of all ages, gender or race. The most frequent complaint is that of itchiness of the~     vulva but pain may also occur. Some women will experience no symptoms at all. However, it is~     important to treat this condition since it may increase and cause important scarring and~     deformity. In less than 5% of cases, cancer may develop.~      Lichen Sclerosus is a chronic disease which can be controlled but not cured. Topical~     corticosteroids are the usual treatment for this condition. Though this treatment is~     generally well tolerated, some patients may not present a sufficient response or may develop~     mainly local and rarely systemic side effects. In this perspective, an alternative treatment~     would be beneficial.~      Tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema~     and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of~     patients. Tacrolimus acts as a non-steroidal anti-inflammatory agent (NSAI) without causing~     the usual side effects seen with the prolonged use of topical corticosteroids.~      This study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar~     lichen sclerosus by comparing it with the standard topical corticosteroid treatment.~   "
214065|NCT00757848|"~     The purpose of this study is to investigate if treatment with AZD9668 for 28 days is~     effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance~     which does not have any action).~   "
214066|NCT00757835|"~     A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour~     IOP control and safety of travoprost/timolol fixed combination given once in the evening,~     versus that of latanoprost/timolol fixed combination given once in the evening in patients~     with exfoliative glaucoma. The primary objective of this trial is to compare the quality of~     24-hour IOP control after 3 months of chronic therapy with these two medications.~   "
214067|NCT00757822|"~     This study will compare two different drug regimens (oral dronabinol versus intravenous~     ondanseteron) for the prevention of post-operative nausea and vomiting (PONV).~   "
214068|NCT00757809|"~     Study to investigate the occurence of diarrhea after either once daily or twice daily dosing~     for 14 days.~   "
214069|NCT00757796|"~     Studies demonstrate that sleep disturbances are associated with cognitive dysfunction and~     attention deficit. However the correlation between the severity of obstructive sleep apnea~     and the degree of cognitive dysfunction was not demonstrated. Our hypothesis is that patients~     suffering from a more severe sleep apnea will demonstrate a greater degree of cognitive~     dysfunction.~   "
214070|NCT00757783|"~     The purpose of this research study is to compare changes in triglyceride and other lipids~     (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir~     800/100 mg once daily versus atazanavir/ritonavir 300/100 mg once daily in combination with a~     fixed-dose background regimen consisting of emtricitabine [FTC]/tenofovir [TDF] 200/300 mg~     once daily). This study will also evaluate the safety (adverse events), effectiveness, and~     tolerability of darunavir/ritonavir and atazanivir/ritonavir over 48 weeks.~   "
214071|NCT00757770|"~     The purpose of this study is to evaluate the lot-to-lot consistency of three production lots~     of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged~     2 months at the time of first vaccination.~   "
214072|NCT00757757|"~     This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer~     and bone metastases~   "
214073|NCT00757744|"~     A randomized clinical trial evaluating the reduction of HIV risk behaviors and drug use when~     providing integrated behavioral drug and HIV risk reduction counseling (BDRC) along with~     methadone maintenance treatment in Wuhan, China~   "
214074|NCT00757731|"~     Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the~     treatment of fibromyalgia syndrome.~   "
214113|NCT00757224|"~     Parental smoking is associated with increased frequency of respiratory diseases including~     hospitalizations in infants.~      Study hypothesis: Parental education regarding the association between parental smoking and~     respiratory diseases in the infant, and guidance on ways to decrease smoke exposure by the~     infant, provided shortly after the infant is born, will decrease infants' morbidity.~   "
214114|NCT00757211|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between~     genes and the environment in patients with breast cancer.~   "
214075|NCT00757718|"~     Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative~     estimates, 4% of the adult female population has SDB. SDB is a recognized cause of~     hypertension and treating SDB can improve blood pressure control in people with hypertension.~     More recently, research efforts have looked at SDB as a possible cause of pregnancy induced~     hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best~     way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This~     is inconvenient and for pregnant women often impossible to arrange, considering the short~     time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at~     the University of Saskatchewan are now looking at whether an adequate sleep assessment can be~     performed at the bedside - either in a patient's home or on the hospital ward. The~     researchers will also look at different treatment options for sleep apnea, to see if these~     can improve blood pressure control in this patient population, and delay the need for early~     delivery. The information from this study may result in a detailed sleep assessment becoming~     part of the complete assessment of women with PIH. There is an association between sleep~     disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may~     represent an effective addition to the management of the cardiovascular and metabolic~     perturbations of GHTN We plan to assess women whether treating SDB with one of two methods~     will improve the management of GHTN. We will also assess if one method is more effective than~     the other.~   "
214076|NCT00757705|"~     The purpose of the study is to explore the maintained efficacy, tolerability, and safety of~     flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia~     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often~     with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully~     treated with other oral atypical antipsychotic medication.~   "
214077|NCT00757692|"~     Purpose To define the efficacy, tolerability and safety of Vandetanib in combination with~     bicalutamide in patients with chemotherapy naive hormone refractory prostate cancer~      Hypothesis There will be a PSA response when Vandetanib is given in combination with~     Bicalutamide in Chemotherapy Naive Hormone refractory prostate cancer patients.~   "
214078|NCT00757679|"~     Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared~     to placebo, in fibromyalgia out-patients~   "
214079|NCT00757666|"~     The APPROPRIATE study will compare differences in functional capacity (peak VO2) between~     chronotropically incompetent patients randomized to receive rate responsive pacing driven by~     either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).~   "
214080|NCT00757653|"~     Retrieval study and histological examination of BiMetric Femoral Components with~     hydroxyapatite coatings.~   "
214081|NCT00757640|"~     The patients will be divided into two groups: in the first group the patient will be~     submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer~     (subtotal or total gastrectomy), while in the second group will be submitted to standard~     gastric surgery only.~   "
214082|NCT00757627|"~     The purpose of this study is to collect disease burden of OA and the effectiveness and~     patient satisfaction of treatment by Etoricoxib in the normal practice setting.~   "
214083|NCT00757614|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between~     genes and the environment in patients with cancer in East Anglia, Trent, or West Midlands of~     the United Kingdom.~   "
214084|NCT00757601|"~     This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     single doses of MK1006~   "
214085|NCT00757588|"~     The purpose of this study is to compare the effects of saxagliptin with those of placebo as~     add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and~     52 weeks.~   "
214086|NCT00757575|"~     Streptococcus pneumoniae is a major cause of pneumonia, among infants and children in Japan~     and worldwideThis study plans to investigate the rate of invasive pneumococcal disease IPD ~     and the rate of hospitalizations due to pneumonia in Okinawa and the Eastern half of Hokkaido~     Currently, only a limited information about pneumococcal disease burden is available in~     Japan.~   "
214087|NCT00757562|"~     This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks~     of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or~     chronic hives. All of the subjects enrolled in this trial were previously identified in an~     earlier trial to be poor metabolizers of desloratadine.~   "
214088|NCT00757549|"~     RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) and~     fludeoxyglucose F 18 (FDG) PET scans, may help doctors predict a patient's response to~     treatment and help plan the best treatment.~      PURPOSE: This pilot trial is studying FLT and FDG PET scans to see how well they evaluate~     response to cetuximab, cisplatin, and radiation therapy in patients with advanced cancer of~     the oropharynx, larynx, or hypopharynx.~   "
214089|NCT00757536|"~     Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an~     encircling band for patients with RRDs.~   "
214090|NCT00757523|"~     The purpose of this study is to compare the effectiveness of two marketed products in~     subjects with facial acne vulgaris~   "
214091|NCT00757510|"~     The Congenital Heart Disease Research Registry (CHDRR) is a program dedicated to~     understanding the etiology and improving the treatment of Congenital Heart Disease (CHD).~     This Registry will act as a central coordinating center for recruiting subjects with CHD and~     will provide infrastructure and guidelines for researchers studying the causes and treatment~     of CHD. Investigators working directly with the Registry will have access to biological,~     demographic and phenotype data from a significant pool of participants with CHD.~   "
214115|NCT00757198|"~     Prospective double blind study comparing two remifentanil dosing protocols (0.1 and 0.3~     mcg/kg/min) during cardiac surgery. Main outcome measures are postoperative opioid~     requirements (PCA oxycodone) and postoperative pain (VAS, verbal rating scale).~   "
214116|NCT00757185|"~     The scientific aims of the study are to determine how peripheral microcirculatory~     responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local~     heating and to determine the mechanism for testosterone effects on peripheral~     microcirculatory responsiveness in women with PCOS.~   "
214092|NCT00757497|"~     This study will test whether transcranial direct current stimulation (TDCS) can be used~     safely in children with schizophrenia and if it can improve memory and attention span or~     auditory hallucinations in these children, at least temporarily. TDCS has temporarily~     improved memory and attention span in healthy adults and a similar method called TMS has~     relieved auditory hallucinations in adults with schizophrenia. For the TDCS procedure, the~     child sits in a chair and two soft sponge electrodes are placed on the child s forehead and~     held in place with a soft wrapping. One sponge electrode is placed on an arm. The electrodes~     are attached to a stimulator with a wire.~      Children with schizophrenia who meet the following criteria may be eligible for this study:~        -  Are 10 yrs or older age.~        -  Are participating in NIH protocol 03-M-0035.~        -  Are on a stable medication regimen for at least 6 months.~        -  Have problems with memory and attention span or have auditory hallucinations.~      Participants are randomly assigned to receive either real or sham TDCS on an inpatient or~     outpatient basis in 20-minute sessions daily, except weekends, for 10 days. For real TDCS,~     patients receive stimulation to the front of the brain. For sham stimulation, the children~     have electrodes placed on the forehead, but no actual stimulation is delivered. In addition~     to TDCS, patients have the following procedures:~        -  Checks of blood pressure, pulse and breathing rate before, during and right after each~          stimulation and again 8 hours later.~        -  Electrocardiogram (EKG) and electroencephalogram (EEG) before starting stimulation and~          after completing the 10 days of TDCS.~        -  Interviews and examinations to check for side effects of TDCS.~        -  Pen-and-paper or computer tests of learning, attention and memory.~        -  At the end of the 10 sessions, children who were in the sham TDCS group are offered the~          same number of sessions of active TDCS.~        -  Follow-up telephone call 1 month after the end of stimulation to see how the child is~          doing.~        -  1- to 2-day outpatient visit 6 months after the stimulation. This visit includes~          interviews with the parent and the child, rating of the child s psychiatric symptoms,~          and pen-and-paper or computer tests of thinking, attention and memory.~   "
214093|NCT00757484|"~     The purpose of this study is to establish normal postoperative changes in blood pressure in~     women undergoing scheduled gynecologic surgery requiring inpatient postoperative care. Also,~     to establish if there is a difference in normal postoperative blood pressure changes between~     elderly and non-elderly women undergoing scheduled gynecologic surgery requiring inpatient~     postoperative care.~   "
214094|NCT00757471|"~     Macular Hole Surgery with two different Dyes~   "
214095|NCT00757458|"~     The purpose of this study is to verify the existence of bacterial and/or fungal contamination~     during different technics of propofol with or without EDTA continuous infusion in patients~     undergoing general anesthesia.~   "
214096|NCT00757445|"~     This study presents the investigators results on patients treated for infection in the~     implemented hip prosthesis. Debridement and prosthesis retention is the method, followed by~     antibiotic treatment. The investigators present treatment results, predisposing factors and~     microbiological data.~   "
214097|NCT00757432|"~     The purpose of the study is to describe the patient experience, including pain scores, use of~     pain medications, resumption of usual activities, and bowel function in the post-operative~     period following robotic urogynecologic surgery. Additionally, to describe peri-operative~     parameters of robot-assisted urogynecologic surgery.~   "
214098|NCT00757419|"~     The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in~     the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to~     placebo (inactive substance). Safety and tolerability variables will be closely monitored~     throughout the study.~   "
214099|NCT00757406|"~     To demonstrate that ImpediMed L-Dex U400 can be used to assess unilateral Lymphoedema of the~     leg using the same principles for arms.~   "
214100|NCT00757393|"~     The primary objective of this study is to test the hypothesis that growth hormone,~     administered daily by subcutaneous injection for 2 years will result in a significantly~     greater BMD Z-score over optimal standard therapy.~   "
214101|NCT00757380|"~     Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two~     different Dyes for Epiretinal Membrane Surgery.~   "
214102|NCT00757367|"~     Lavage fluid (BAL) is inserted into a lung lobe using a flexible bronchoscope. The fluid is~     aspirated out to remove any remaining TI. It's performed twice at specific time points in 12~     healthy volunteers. BAL fluid will be analyzed for insulin and FDKP.~   "
214103|NCT00757354|"~     A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip~     articulating surfaces in cementless total hip arthroplasty.~   "
214104|NCT00757341|"~     This study will assess the mass balance, metabolic disposition, and identification of~     metabolites following single oral administration of [14C]-SKI-606 in healthy male subjects.~   "
214105|NCT00757328|"~     Cross-sectional observational, non interventional, multicenter study of retrospective review~     of clinical records of ambulatory followed up bipolar patients in order to record~     epidemiological aspects of the course of the disorder, more specifically of bipolar~     depression episodes and the clinical practices carried out by psychiatrists in Spain in~     bipolar depressive episodes~   "
214106|NCT00757315|"~     Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on~     the skin of the back of the head and neck. The purpose of this new study is to determine how~     well a hair removal laser (NdYag Laser) works in treating AKN.~   "
214107|NCT00757302|"~     Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field~     of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of~     sentinel lymph nodes (SLN) in breast surgery. Patients and Methods: SLN biopsy will be~     performed on 110 patients and the CarolIReS camera will be used preoperatively to localize~     SLNs. During surgery, individual removal of SLNs will be performed using a gamma probe named~     CarolIReS and their activity will be measured with a gamma ray counter. At the end of~     surgery, the CarolIReS camera will be used again to check the quality of surgery which will~     be followed by a surgical excision in case of remaining SLNs. Objectives: The main objective~     of this study is to evaluate the performances of the CarolIReS camera in assessing the~     axillary drainage of breast tumors and the surgical removal of SLNs. In addition, the~     possible correlation between the activity, the size, and the metastatic involvement of the~     SLNs will also be studied.Study hypothesis: Intraoperative cameras could be used to improve~     the efficiency of the SLN procedure~   "
214108|NCT00757289|"~     The study is to compare the efficacy of autologous platelet concentrate injections to~     corticosteroid injection in patients suffering from tennis elbow with respect to pain and~     function.~   "
214109|NCT00757276|"~     Evaluation of Copeptin in the differential diagnosis of diabetes insipidus.~   "
214110|NCT00757263|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between~     genes and the environment in patients with ovarian cancer.~   "
237379|NCT00448110|"~     This study will compare repeated intermittent IV dosing of diclofenac in patients with~     moderate to severe post-surgical pain from abdominal or pelvic surgery.~   "
214117|NCT00757172|"~     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from~     growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination~     chemotherapy together with panitumumab and radiation therapy before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving panitumumab together with docetaxel,~     cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed,~     locally advanced esophageal cancer or cancer of the gastroesophageal junction.~   "
214118|NCT00757159|"~     The aim of this investigation is to determine whether a synthetic hydroxyapatite is as~     effective as an enamel matrix protein for periodontal regeneration in patients who have~     intra-bony periodontal defects.~   "
214119|NCT00757146|"~     This is a chart review study of neonates admitted to Primary Children's Medical Center or~     University of Utah NICU who had or developed a diagnosis of bronchopulmonary dysplasia (BPD)~     and were treated for this condition with inhaled nitric oxide (iNO) beginning after the 4th~     week of life. For this study BPD will be defined as need for supplemental oxygen on day 28 of~     life. The data collection from the medical record will gather demographics on admission~     (birth weight, gestational age, etc); past medical history from transferring hospitals;~     admission diagnoses; hospital respiratory care treatment course and laboratory/xray findings;~     nutrition and growth; and discharge diagnoses including all major neonatal morbidities such~     as absence or severity of intraventricular hemorrhage, retinopathy of prematurity, or hearing~     deficits. The data will be compiled and compared to data previously published on similar~     infants with BPD but not treated with iNO.~   "
214120|NCT00757133|"~     The research hypothesis for this study is to possibly reduce the incidence of incisional~     hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from~     25% to 5% by mesh augmentation during closure of the laparotomy. The study is designed as a~     prospective randomised multi-centre trial, randomising patients in 2 groups concerning the~     surgical technique of the closure of the abdominal wall.~   "
214121|NCT00757120|"~     Emphysema, a common type of chronic obstructive pulmonary disease (COPD), is a long-term lung~     disease that is usually caused by cigarette smoking. This study will examine both current~     smokers and former smokers who have emphysema, as well as current and former smokers who do~     not have emphysema, to determine if certain factors found in the blood are related to the~     risk of developing emphysema.~   "
214122|NCT00757107|"~     This evaluation is conducted to evaluate the safety and performance of two different stem~     lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are~     compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and~     radiostereomektric analysis~   "
214123|NCT00757094|"~     Fasting (refraining from eating and drinking) during the day is safe while receiving~     chemotherapy.~   "
214124|NCT00757081|"~     The combination of phosphatidylcholine (PPC) and deoxycholate (DC) injected into subcutaneous~     fat is often popularly referred to as Lipodissolve therapy. Despite its attractiveness as~     an easy and noninvasive cosmetic treatment, the safety, effectiveness, and how the injections~     might work remain unclear. This study will investigate the hypothesis that injections of~     PPC/DC will reduce the amount body fat in the treated area. If so, the mechanisms responsible~     for the fat loss will be explored to find out whether fat cells die from toxic effects or are~     broken apart by the PPC/DC. Patients will receive at least 2 (no more than 4) treatments with~     PPC/DC injections every 2 months. Several methods of measuring fat loss will be used in the~     study, including photography and measurement of patients, tissue biopsy, blood tests, and~     MRI. The study will also record side effects of the treatments as well as patient~     satisfaction.~   "
214125|NCT00757068|"~     The purpose of this study is to evaluate the relative efficacy of a postpartum smoking~     relapse prevention program, Strategies to Avoid Returning to Smoking (STARTS), and a~     supportive, nondirective comparison condition (SUPPORT) to increase the proportion of women~     who remain abstinent through 12 months postpartum. We hypothesize that women randomized to~     STARTS will maintain higher rates of smoking abstinence at 6 and 12 months postpartum, and~     expect STARTS to increase the length of time abstinence is sustained relative to SUPPORT.~   "
214126|NCT00757055|"~     The purpose of this study is to investigate whether the medicine ivabradine, a novel drug~     which slows the heart rate has a favourable effect on patients with diastolic heart failure.~      Ivabradine is a specific heart rate-lowering agent. It has a licence for treating patients~     with angina who are intolerant of agents such as beta blockers or whose angina is not~     adequately controlled. It has been shown to prolong exercise tolerance in these patients and~     to reduce the frequency of chest pain. Its mechanism of action is felt to be purely due to~     reducing heart rate, by as much as 10 beats per minute at rest, as well as by reducing the~     heart rate response to exercise.~      Patients with diastolic heart failure often complain of breathlessness on exertion which~     relates to the stiffness or lack of compliance of their heart i.e. the heart fails to relax~     rapidly enough to allow it to fill with blood between each heart beat. This may result in~     high pressure in the heart chamber which backs up in to the lungs and may be experienced as~     breathlessness. There is little evidence that any specific therapy benefits patients with~     this type of heart failure besides treating coexisting problems such as high blood pressure~     or angina. By slowing the heart rate down with ivabradine, the heart would have a longer time~     to fill during exercise which would make it more effective. This slowing of the heart rate~     may therefore relieve the breathlessness experienced on activity such as walking to the shops~     or up a flight of stairs etc.~   "
214127|NCT00757042|"~     This study is a phase 1 single dose escalation study of AMG 157 in healthy subjects and~     subjects with moderate to severe atopic dermatitis. The purpose of the study is to evaluate~     the safety, tolerability and pharmacokinetics of AMG 157.~   "
214128|NCT00757029|"~     The noradrenergic system plays a known role in attentional systems and suspected causal role~     in attention deficit/hyperactivity disorder(ADHD).Methylphenidate also has been suspected as~     a inhibitor of norepinephrine transporter(SLC6A2). The investigators hypothesis is that~     norepinephrine transporter polymorphism is associated with responses and adverse effects of~     OROS-methylphenidate in treatment of ADHD.~   "
214129|NCT00757016|"~     To evaluate the pain relief effect of locally injected corticosteroid treatment in women with~     long-lasting low back pain beginning in pregnancy. We hypothesize that the insertion of the~     sacrospinous ligament on the ischial spine would be a source of pain and therefore be a~     target for therapy.~      Primary outcome measure is reported pain intensity on visual analogue scale and secondary~     outcome measures number of pain-drawing locations, pain-provoking test results and tests of~     function.~   "
214130|NCT00757003|"~     PURPOSE OF RESEARCH:~      Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to~     open surgery that may decrease morbidity and mortality, particularly in high risk patients.~     Optimal patient selection, based on pathology and anatomy, is being defined. Technically~     successful implantation requires adequate assessment of pathology and anatomy, and~     development and execution of novel and delicate procedures that resolve the pathology while~     minimizing morbidity and mortality.~   "
214131|NCT00756990|"~     This is an investigation involving the use of a long-acting, injectable form (depot) of~     naltrexone as a treatment for persons who have a history of opioid dependence, with up to 40~     on parole/probation and 20 non-parolees. The test is a pilot study of up to 60 subjects~     treated with 6 months of depot naltrexone plus Psychosocial Treatment .~   "
214132|NCT00756977|"~     This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA~     approved bowel preparation in adult subjects undergoing colonoscopy.~   "
214133|NCT00756964|"~     Acute kidney injury is associated with a rise in serum uric acid during cardiovascular~     surgery and can cause poor blood flow to the kidneys making them vulnerable to kidney injury.~     We hypothesize that hyperuricemia, particularly if chronic and marked, is a risk factor for~     acute kidney injury. The preoperative lowering of serum uric acid will reduce the incidence~     of acute kidney injury following cardiovascular surgery.~   "
214134|NCT00756951|"~     Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or~     radiation regiments used to treat cancer. This study examines the investigational drug SCV-07~     and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can~     possibly increase a broad immune system response, thus lowering the painful side effects~     experienced when treated for head and neck cancer.~      The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability~     to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck~     cancer.~   "
214135|NCT00756938|"~     This study will explore the dose-response of losartan as well as the safety and tolerability~     in children from 6 months to 6 years of age.~   "
214136|NCT00756925|"~     Cocaine dependence is an insidious disease underscored by a powerful proclivity to relapse~     despite an individual's ability to recognize the deleterious consequences of continued drug~     use. To date, there are only a limited number of treatments, and no FDA approved medications~     for the treatment of cocaine dependence. Attempts to find reliable and successful treatments~     for cocaine dependence may be marred by gender differences in brain chemistry, structure, and~     function that are manifested as drug craving and relapse. For example, cues, drug exposure,~     and stress promote relapse, yet females appear be more susceptible to stress induced relapse,~     while males may be more susceptible to cue induced relapse. Therefore identifying the neural~     substrates involved in processing the valence of internal and external stimuli may provide~     further insight into cocaine dependence and provide more effective therapeutic strategies~     aimed at preventing relapse.~      Corticotropin releasing hormone (CRH) is a pharmacological activator of the hypothalamic~     pituitary adrenal (HPA) axis, and has been implicated in stress induced drug relapse.~     Corticotropin releasing hormone receptors are located at extrahypothalamic brain nuclei that~     have been implicated in determining the significance of both internal (somatic) and external~     (environmental) stimuli. The primary directive of this pilot project is to utilize functional~     magnetic resonance imaging (fMRI) to identify possible brain nuclei associated with with~     stress induced drug craving in cocaine dependent females.~   "
214137|NCT00756912|"~     This is a study designed to assess the safety of administration of up to 3 dose levels of~     eritoran in subjects undergoing or scheduled to undergo allogeneic bone marrow transplant~     (BMT). An allogeneic BMT is the transplantation of blood stem cells taken from the bone~     marrow or blood of another person.~   "
214138|NCT00756899|"~     The Vitamin D study is designed to investigate the effect of body fat mass on vitamin D~     levels in children. Earlier studies have shown that individuals with increased fat mass may~     have low vitamin D levels.~      Our specific hypothesis states that children with increased fat mass will have lower blood~     levels of vitamin D when compared to non-obese children.Since vitamin D is the primary~     hormone for bone mineralization in humans, low levels of vitamin D could lead to decreased~     bone mineral content in these children.~   "
214139|NCT00756886|"~     The purpose of this study is to determine if atorvastatin (Lipitor) reduces the occurence of~     abnormal heart rhythm (atrial arrhythmia) following non cardiac thoracic surgery.~   "
214140|NCT00756873|"~     The aim of this study is to test the analgesic efficacy of etoricoxib (90 mg or 120 mg qd.~     perioperatively) for post-operative pain relief.~      The primary endpoint is as follows:~        -  does preoperative etoricoxib reduce the post-operative opioid utilization in patients~          undergoing elective tonsillectomy under general anaesthesia (i.e. the post-operative~          opioid-sparing effect of etoricoxib in humans).~      The secondary endpoints are as follows:~        -  does the etoricoxib medication have an impact on PONV or activities of daily~        -  does the etoricoxib medication influence the blood loss during surgery or the incidence~          of postoperative bleeding~        -  does the etoricoxib medication influence the operation time. In addition, adverse~          effects of etoricoxib will be documented.~   "
214141|NCT00756860|"~     The purpose of this study is to determine if subjects on 2g AMG 223 will achieve 60% or~     greater reduction in urinary phosphorus from baseline compared to subjects on 2g Renagel®.~      Renagel®, Sevelamer HCl is currently the market leader for the treatment of hyperphosphatemia~     in patients on dialysis.~   "
214142|NCT00756847|"~     The purpose of this study is to evaluate the safety and tolerability of XL147 in combination~     with paclitaxel and carboplatin in adults with solid tumors. XL147 is a new chemical entity~     that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce~     apoptosis (programmed cell death) in tumor cells. In clinical practice, the combination of~     paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors,~     including ovarian cancer, endometrial cancer and non-small cell lung cancer (NSCLC).~   "
214143|NCT00756821|"~     The goal of this pilot study is to identify a marker or panel of markers in the blood or~     urine from a wide range of Spinal Muscular Atrophy (SMA) patients that segregates with~     measures of clinical severity. From this identification of candidate biomarkers, it is hoped~     that further investigations, both longitudinal natural history and clinical efficacy studies,~     will verify a biomarker with the sensitivity and specificity that will allow its eventual use~     as a validated pharmacodynamic marker or surrogate endpoint. In addition, this effort may~     elucidate biological pathways that may be potential therapeutic targets.~   "
214144|NCT00756808|"~     In face of the increased rates of tuberculosis in residents of long term care facilities,~     annual screening for latent tuberculosis is recommended. Tuberculin skin testing using~     purified protein derivative (PPD) is used for this purpose. Sensitivity of the PPD testing~     is, however, dependent on a normal T cell function. It is now evident that the immune system~     undergoes age-associated alteration known as immune senescence. The depressed T-cell~     responses may clinically manifest as attenuated delayed-type hypersensitivity. This~     attenuated reaction may affect the sensitivity of the PPD in detection of latent TB in the~     elderly.~      This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay,~     T-SPOT.TB, for detection of latent tuberculosis in nursing home patients who are 65 years of~     age or older.~   "
214145|NCT00756795|"~     The general hypothesis of this research is that patients who have undergone treatments for~     Head Neck Cancer have a decreased quality of life and experience depression and fatigue.~     Increasing and sustaining physical activity of these patients will improve their emotional~     well-beings, increase their immunological response, improve wound healing, lessen fatigue and~     improve their general functionality and quality of life.~      The purposes of this study are to: (1) determine the effectiveness of the 12-week exercise~     intervention program in increasing physical activity in head and neck cancer patients; (2)~     determine if physically active patients differ in quality of life, depression and fatigue~     during the course of the study; and (3) determine if the change in physical activity levels~     is related to changes in the immune responses in human.~   "
214146|NCT00756782|"~     The purpose of this study is to evaluate the efficacy and safety of TAC-101 after~     Transcatheter Arterial Chemoembolization (TACE) in patients with advanced, unresectable~     hepatocellular carcinoma (HCC) who are being scheduled for TACE.~   "
214147|NCT00756769|"~     Systemic lupus erythematosus (SLE) is a severe, disabling systemic autoimmune disease~     characterized by the production of autoantibodies. The clinical symptoms and immunologic~     manifestations of SLE are diverse. African-Americans have a 3 fold increased incidence of~     SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with~     Caucasians. Our central study hypothesis is that there are specific genetic factors that~     interact with environmental exposures leading to the development of SLE. The African-American~     Gullah population lives on the Sea Islands of South Carolina and Georgia. They are unique in~     their genetic homogeneity with minimal Caucasian admixture, making them an ideal cohort to~     address questions of environmental and genetic influence on development and progression of~     SLE.~   "
214148|NCT00756756|"~     The investigators applied G-CSF to patients 2 weeks after acute anterior MI and successful~     PCI to evaluate the efficacy and safety of G-CSF in improving myocardial function as cytokine~     which improve inflammation and mobilize stem cells from bone marrow for regeneration of~     myocardium.~   "
214149|NCT00756743|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.~   "
214150|NCT00756730|"~     For participants with HIV taking either lopinavir or fosamprenavir who have elevated~     triglycerides, this trial will study the change in triglycerides after switching protease~     inhibitors.~   "
214151|NCT00756717|"~     The purpose of this research project is to study the effect of a research (investigational)~     drug, MK-0752 combined with either tamoxifen or letrozole on breast cancer cells.~      Tamoxifen and letrozole are standard hormone treatments used to treat breast cancers that are~     positive for the estrogen receptor. However, over time the breast cancer cells can become~     resistant to tamoxifen and letrozole. MK-0752 is in a class of drugs called gamma secretase~     inhibitors. Gamma secretase inhibitors may play a role in reversing the resistance to drugs~     such as tamoxifen and letrozole.~   "
214152|NCT00756704|"~     Although 78% of smokers report that a health professional has previously advised them to quit~     smoking, most smokers are not advised to stop smoking or offered assistance with smoking~     cessation during a given ED visit. There are multiple barriers to routine implementation of~     smoking cessation guidelines by emergency clinicians, however, and rigorously performed~     clinical trials are needed to demonstrate that routine screening and counseling of ED~     patients results in increased quit rates. To determine the feasibility of implementing the~     Agency for Healthcare Research and Quality (AHRQ) Smoking Cessation Guideline in the ED, we~     will conduct a clinical trial in 974 ambulatory adult smokers who present to 2 emergency~     departments, using a pre-post design. During the 3-month baseline period, clinicians will~     perform their usual duties but will not receive training in use of the AHRQ Guideline. Based~     on the Chronic Care Model, the 3-month intervention period will include: 1) a tutorial on~     brief cessation counseling for ED nurses and physicians, 2) use of an ED algorithm that~     includes recommended tobacco counseling items, 3) fax referral of motivated smokers to~     Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy, and~     4) group and individual feedback to ED staff. We will conduct exit interviews of ED patients~     to assess performance of guideline-recommended actions by ED staff and 3- and 6-month~     telephone follow-up to determine 7-day point-prevalence abstinence (with biochemical~     confirmation of self-reported quitters at 6 months). Our main analyses will examine the~     contrast between the intervention and control periods in the performance of~     guideline-recommended actions and in 6-month quit rates, using hierarchical logistic~     regression to adjust for baseline differences in potentially confounding patient variables.~     In secondary analyses, we will assess the change in attitudes of ED nurses and physicians~     toward smoking cessation counseling. This feasibility study will determine the receptivity of~     patients and ED staff to the guideline-based intervention and will provide estimates of~     effect size in planning a full scale multi-site clinical trial of the study intervention in~     community hospital EDs.~   "
214153|NCT00756691|"~     Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's~     tumour that may help predict patient outcomes and/or help inform patient management~     decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because~     18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the~     processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down)~     and eliminated by the body.~   "
214154|NCT00756678|"~     Efficacy and acceptability of two new artificial tears following two weeks of treatment in~     patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then~     crossover to the alternate treatment for 7 days.~   "
229071|NCT00558584|"~     The purpose of this study is to investigate the effects of immunoadsorption and subsequent~     IgG substitution in patients with dilated cardiomyopathy compared to a control group.~   "
214155|NCT00756665|"~     The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen~     active surveillance as a management plan for their prostate cancer. Active surveillance is~     defined as close monitoring of prostate cancer with the offer of treatment if there are~     changes in test results. This study seeks to discover markers that will identify cancers that~     are more aggressive from those tumors that grow slowly.~   "
214156|NCT00756652|"~     In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel~     silicone gel-filled breast implants for use in women who are undergoing primary or revisional~     breast augmentation and primary or revisional breast reconstruction surgery. This~     postapproval study is intended to satisfy one element of FDA's postapproval monitoring~     requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of~     data collection for the study to the collection of only secondary procedure/reoperation data~     for MemoryGel participants.~   "
214157|NCT00756639|"~     The goal of this clinical research study is to learn if whole brain radiation can lower the~     chances of developing brain tumors in patients with small cell carcinoma of the urinary~     tract, including the bladder. The safety of whole brain radiation will also be studied.~   "
214158|NCT00756626|"~     This Integrated Project (Research + Extension) aims to reduce the risk of early childhood~     overweight through changing bottle-feeding behavior. Excess bottles of whole milk and sweet~     beverages beyond the advised weaning age of 12 months, inappropriate bottle-feeding, has~     been linked to overweight. Our pilot of this intervention reduced bottle use.~      COMPONENTS OF THE 'FEEDING YOUNG CHILDREN STUDY' (FYCS):~        1. Randomized Controlled Trial (RCT)- of a bottle-weaning intervention in low-income~          multi-ethnic toddlers, will enroll n=464 12 month olds using >2 bottles/day from two WIC~          sites. Bottle use, anthropometrics, dietary intake, and nutrient density outcomes will~          be assessed at Baseline, and 4 times over a 12 month follow-up.~        2. Observational Study- nested within the RCT, will describe dietary intake and nutrient~          density data (24 hour recalls) for this period of feeding transitions. FYCS fills a gap~          in knowledge about this population's dietary habits, and their relationship to bottle~          use.~        3. Extension- our Marketing Department will produce: a 5-8 minute 'infomercial' and~          nutritionist and client guides (freely downloadable) at WIC, maternal/child health, and~          pediatric websites, and; a public TV segment. We will disseminate findings through a)~          the National WIC Association, b) nutrition & pediatric journals, and; c) lay print,~          media, and websites with assistance from our Public Relations Department.~   "
214159|NCT00756613|"~     CSP #465, Glycemic Control and Complications in Diabetes Mellitus Type 2, was a randomized~     unblinded clinical trial comparing tight glycemic control to standard glycemic control. Tight~     glycemic control consisted of giving patients appropriate diabetic medications to lower the~     patient's HbA1c to around 7%, whereas standard control attempted to lower the patient's HbA1c~     to between 8% and 9%. The study was conducted at 20 VA medical centers. One thousand seven~     hundred and ninety two patients were randomized over the 2 year accrual period and then~     followed for an additional 5 years. Follow-up averaged between 5 and 7 years depending upon~     when the patient was enrolled in the study. Patients were seen on average every three months~     in the VA Outpatient Clinics. High blood pressure and elevated cholesterol were aggressively~     treated in patients in both treatment arms. Education regarding diet, exercise, smoking~     cessation and management of very high and very low glucose was also provided. Data were~     collected throughout the study on the patients' physical status, adverse and serious adverse~     events, concomitant medications, and study end points including mortality, heart attack,~     stroke and surgery to fix the arteries in the heart, legs or neck. The study consisted of~     broad use of all anti-diabetic treatments commercially available between 2000 and 2008~     including oral medications and insulin. Study required medications and all study clinic~     visits were provided free of the usual VA co-pay. Active clinical follow-up of the sample~     ended on May 31, 2008. With the end of the clinical trial the patients were transitioned back~     to usual patient care services, treatment regimens were adjusted where appropriate and future~     treatment will be dictated by the patient's health and his/her health care provider.~      It is important to clarify that with the completion of the active clinical trial and~     transitioning of patients to this observational trial, all responsibility for the care,~     treatment and oversight of the study patients will become the responsibility of the patients'~     Primary Care Physician. The Long Term Follow-up will not collect adverse or serious adverse~     events, or actively treat or have any hands-on care responsibility for the study~     participants.~      The proposed Long Term Follow-up Study will consist of centralized computer database searches~     and annual survey questionnaires related to quality of life and self-reported events~     pertinent to the CSP #465 study.~   "
214160|NCT00756600|"~     The primary purpose of the GAS study is to determine whether different types of anesthesia~     (Regional versus General) given to 720 infants undergoing inguinal hernia repair results in~     equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of~     apnea in the post-operative period after both regional and general anesthesia for inguinal~     hernia repair in infants. This study is important as it will provide the greatest evidence~     for safety or toxicity of general anesthesia for human infants.~   "
214161|NCT00756587|"~     The purpose of the current study is to investigate the effect of using cup feeding for~     preterm infants during NICU stay on breastfeeding outcomes after discharge. The following~     hypotheses are being tested:~        1. Infants Fed by cup during NICU stay will have higher breastfeeding proportions than~          infants fed by bottle~        2. Infants fed by cup during NICU stay will have higher breastfeeding behaviour score on~          the Preterm Infant Breastfeeding Behavior Scale than infants fed by bottle~   "
214162|NCT00756574|"~     The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator~     in protecting nurses from influenza in the hospital setting. The investigators propose a~     non-inferiority randomized controlled trial whereby nurses are randomized to either a~     surgical mask or an N95 respirator when caring for patients with febrile respiratory illness~     during the influenza season. The hypothesis is that the surgical mask offers similar~     protection against influenza to that of the N95. The specific objective of the study is to~     assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as~     secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for~     respiratory illness, and lower respiratory infection), are similar among nurses using a~     surgical mask compared to those using an N95 respirator.~   "
214163|NCT00756561|"~     The purpose of this investigational study is to find out what hormones are present in healthy~     male testicles using fine needle aspiration.~   "
214164|NCT00756548|"~     This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA~     approved bowel preparation in adult subjects undergoing colonoscopy.~   "
214165|NCT00756535|"~     The aim of the study is to describe the effects of physical exercise consisting of strength,~     balance and flexibility training on functional abilities and the length of stay in older~     (+75) patients hospitalized in a primary-care health- center hospital.~   "
214551|NCT00751387|"~     The study is a cross sectional, epidemiology study of disease severity for rheumatoid~     arthritis, psoriatic arthritis and ankylosing spondylitis in four geographic regions in~     Australia (Illawarra, Sutherland, Hunter Urban and Hunter Rural).~   "
214166|NCT00756522|"~     Chronic obstructive pulmonary disease (COPD) is a long-term lung disease. People with COPD~     have difficulty breathing because of lung damage. However, for many people with COPD, while~     some areas of the lungs are damaged, other nearby areas are not. This study will examine lung~     tissue from people with and without COPD who are undergoing lung transplantation to~     investigate how and why certain areas of the lungs are damaged in some people but not others.~   "
214167|NCT00756509|"~     The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is~     to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic~     gastrointestinal stromal tumors~   "
214168|NCT00756483|"~     Basic Protocol~        1. Identify participant(s)~        2. Request patient participation/Acquire Consent~        3. Register patient at www.stabilityplus.net through the LOGIN tab~             -  Patient ID (Name/Initials/SSN or any combination thereof)~             -  Gender~             -  Age~             -  Surgical Procedure~             -  Date of Surgery~             -  Select Basic Exercise Program that corresponds with Surgical Procedure~        4. Perform Initial Assessment using Basic Exercises for the Surgical Procedure~        5. Enter Assessment Data at www.stabilityplus.net (through the LOGIN tab/Portal)~        6. Within portal, modify Basic Exercise Program to create customized Stability Plus~          prescription for the patient~        7. Monitor patient progress through Stability Plus portal.~   "
214169|NCT00756470|"~     The goal of this clinical research study is to learn how well lapatinib taken alone, followed~     by taking lapatinib with paclitaxel, and then taking lapatinib with 5-fluorouracil,~     epirubicin, and cyclophosphamide (FEC75) works to help to control Inflammatory Breast Cancer~     (IBC). The safety of this drug combination will also be studied.~   "
214170|NCT00756457|"~     Posterior tibial tendon dysfunction (PTTD) is a problem with the tendon connecting one of the~     lower leg muscles to the foot bone. PTTD can cause pain, swelling, and a flattened foot and~     may require surgery if left untreated. Normal treatment for PTTD includes physical therapy~     exercise. In treating similar conditions in the lower leg, exercises that are active, like~     strengthening, seem to have better results than exercises that are passive, like stretching.~     This study will determine whether adding strengthening exercises to a normal PTTD treatment~     that includes wearing a brace and stretching is more beneficial than just wearing a brace and~     stretching.~   "
214171|NCT00756444|"~     Study 20080008 was a PK sub-study to study 20050251[Japan 20050251A]. This PK protocol was~     amended 20-March-2009 and is now a Phase 2 stand alone study. There are no sites~     participating in the U.S.~      This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU~     in subjects receiving cisplatin and 5-FU with or without panitumumab.~      To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the~     collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the~     point at which the PK of panitumumab is expected to be at steady-state after a dose of 9~     mg/kg given every 3 weeks.~   "
214172|NCT00756431|"~     Evaluated whether HA coated dynamic hip screws can improve the surgical results in~     trochanteric femoral fractures~   "
214173|NCT00756418|"~     A clinical study explores the safety and efficacy of montelukast and to compare the safety~     and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients~     when they are used in conjunction with inhaled steroids.~   "
214174|NCT00756405|"~     The aim of the Antioxidant Study was to compare the efficacy of foods naturally rich in~     antioxidants with that of antioxidants in a pill form on markers of inflammation and plasma~     cholesterol in healthy adults at risk of cardiovascular disease.~   "
214175|NCT00756392|"~     This study is designed to investigate whether filling the rectum with high density barium~     prior to a magnetic resonance spectroscopy (MRS)exam of the prostate improves the quality of~     the acquired spectrum. It is expected that the dense substance should help prevent air from~     entering the rectum and thus susceptibility artifacts in the obtained MRS data should be~     reduced. Ten patients with localized prostate cancer will be recruited for this study. There~     will be no change in treatment planning based on MRS study. Patient will receive standard~     radiation treatment prescribed by radiation oncologist.~   "
214176|NCT00756379|"~     The Century Trial is a single center Phase III randomized study sponsored by the Albert~     Weatherhead III Foundation and conducted by Dr. K. Lance Gould. The study hypothesis is that~     a combined image-treatment regimen of PET + comprehensive program of lifestyle modification~     and lipid lowering drugs to target lipid level will result in an improved cardiovascular risk~     score when compared to current standard optimal medical therapy, potentially resulting in a~     lower rate of death, non-fatal myocardial infarction (MI) and revascularization procedures~     during long term follow-up when compared with current standard of care. If our hypothesis is~     correct, we will not only improve our ability to prevent and treat CAD but we will also~     illustrate that, even with the expenses of behavioral interventions and imaging techniques,~     we can be very cost effective. This information may help patients at risk or with known CAD~     to obtain insurance coverage to prevent the disease as well as providing a more effective way~     of treating it.~   "
214191|NCT00756184|"~     A one-year, randomized, attention placebo-controlled trial investigating the value of~     comprehensive adherence specific interventions, over the course of one year, to enhance~     adherence in both (a) newly diagnosed open-angle glaucoma, or ocular hypertension patients,~     naive to medical therapy and (b) those who have failed monotherapy with any prostaglandin~     analogue (and are therefore candidates for adjunctive therapy) who then are randomized to~     receive only travoprost monotherapy. Subjects will be randomized to two different~     interventions involving direct physician education, each of which will take approximately the~     same amount of physician time: The first will be intensive adherence education that will~     continue throughout the year. The second will be intensive eye care education, but without~     any direct adherence education. All patients participating in the study will be monitored for~     adherence by the TDA. The study will demonstrate for the first time the role of~     adherence-specific training in improving patient adherence and will validate the TDA in~     monitoring and improving adherence in glaucoma. This will correlate with prior work that has~     documented that greater adherence is associated with marked improvement in intraocular~     pressure (IOP) control. A second goal will be seeing whether improving adherence will change~     the course of glaucoma therapy by making therapeutic failures into therapeutic successes by~     reducing the need for adjunctive therapy using only monotherapy with travoprost.~   "
214177|NCT00756366|"~     Heart failure affects approximately 5-6 million North Americans and is increasing in~     prevalence. Sleep-related disorders, such as obstructive sleep apnea (OSA) often coexist~     (11-37% incidence) with heart failure. OSA is the repeated temporary interruption of~     breathing during sleep and occurs when the air passages in the upper respiratory tract become~     blocked during sleep. OSA adversely affects the cardiovascular system resulting in hypoxia~     (decrease in oxygen supply), which decreases the oxygen supply to the heart. Patients with~     OSA are treated with continuous positive airway pressure (CPAP). It has also been shown that~     CPAP reduces angina during sleep, minimizes sympathetic nervous system (SNS) activation and~     improves left ventricular (LV) function, although the mechanism of action is not clear.~     Carbon-11 acetate PET imaging allows for the assessment of how the heart works and how~     efficiently the heart uses oxygen in certain circumstances. Carbon-11 hydroxyephedrine (HED)~     measures cardiac nervous system activity, which may have an effect on heart rate. The study~     will evaluate the term effects of continuous positive airway pressure (CPAP), a common~     treatment for patients with OSA, on the heart's efficiency or ability to work and its effect~     on the nervous system activity of the heart. Two patient groups will be evaluated 1.)~     patients with congestive heart failure and obstructive sleep apnea will be randomized to~     early or late CPAP to address the primary hypothesis of the study and 2.) patients with~     congestive heart failure only (matched control group). Both the primary randomized study~     group and secondary study group will be evaluated using [11C]acetate PET, [11C]HED PET and~     echocardiography. Measurements will be obtained at baseline, 1 week (where possible) and 6-8~     weeks.~   "
214178|NCT00756353|"~     This study was a survey of drug users who obtain buprenorphine from the black market and have~     used buprenorphine during the last month. Subjects were surveyed at various locations~     (streets, railway stations, etc.) with a few simple questions in order to describe the use of~     buprenorphine in this out of care population.~   "
214179|NCT00756340|"~     The main goals of this Phase I study are to learn about the side effects that may occur when~     everolimus and bevacizumab are given to children and young adults and to find the highest~     doses of these drugs that can be given together without causing severe side effects.~     Bevacizumab will be given into the vein (IV) over 30-90 minutes every two weeks and~     everolimus tablets will be given daily by mouth. A cycle of therapy will be four weeks.~   "
214180|NCT00756327|"~     To determine whether AquaLase capsule wash reduces posterior capsule opacification (PCO) in~     pediatric eyes.~   "
214181|NCT00756314|"~     The purpose of this study is to determine whether contraceptive counseling is effective on~     acceptance and use of methods in women following an abortion.~   "
214182|NCT00756301|"~     Interventional spine procedures are an increasingly popular means of diagnosis and treatment~     of spine disease. By convention, local anesthetics are used at the beginning of these~     procedures with the goal of minimizing pain. However, the infiltration of the local~     anesthetic is painful. This initial painful stimulus can heighten pain awareness and cause~     anxiety or excessive movement during the procedure.~      The purpose of this study is to determine patient discomfort with administration of cutaneous~     local anesthetic prior to interventional spine procedures compared to no anesthetic~     administration for different gauge procedural needles. Another purpose is to determine~     patient discomfort with administration of local anesthetic by traditional technique compared~     to an alternative technique and to develop a standardized technique and criteria for local~     anesthetic administration during spine injection procedures that minimizes patient pain, and~     may help reduce the overall risk of these procedures.~      We plan to enroll a total of 200-300 subjects coming to Stanford for symmetric bilateral~     single injections.~   "
214183|NCT00756288|"~     Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for~     the treatment of actinic keratoses.~   "
214184|NCT00756275|"~     The purpose of this study is to evaluate the effects of 12 weeks of varenicline as compared~     to nicotine replacement therapy for smoking cessation among outpatients in treatment for~     substance use disorders. The intervention also incorporates counseling (Brief Advice),~     (adapted for sobriety settings), skills training and medication management.~   "
214185|NCT00756262|"~     The use of LGG will be associated with elimination of VRE colonization.~      The primary comparison will be VRE elimination rates among those patients that receive LGG~     compared to those that receive placebo. The primary endpoint will be the proportion of~     patients with VRE at one week after cessation of administration of study medication or~     placebo. The investigators assume that the placebo group will have very little spontaneous~     elimination of VRE and that the LGG group will be more likely to have eliminated VRE~     colonization at the end of one week.~   "
214186|NCT00756249|"~     The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO)~     is a safe treatment for patients who have suffered an acute ischemic stroke.~   "
214187|NCT00756236|"~     We will compare three study groups receiving metoprolol, esmolol, or placebo. Level of~     anesthesia will be titrated to achieve the same range of BIS value in all groups. Our~     hypothesis is that the metoprolol and esmolol groups will require a lower level of anesthetic~     agent to achieve the targeted BIS range, compared to the placebo group.~      Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac~     protection, decreases anesthetic requirement.~   "
214188|NCT00756223|"~     The main objective of this trial is to provide safety data in terms of drug-related adverse~     events for the recommendation of the dose for further trials in the development of BI 831266.~      Secondary objectives are the collection of antitumour efficacy data and the determination of~     the pharmacokinetic and pharmacodynamic profile of BI 831266.~   "
214189|NCT00756210|"~     The objective of this trial is to determine the effect of different lifestyle interventions~     such as aerobic exercise and alternative resistance training methods, combined with a~     hypocaloric diet, on weight, body composition and metabolic risk factors in overweight and~     obese adults.~   "
214190|NCT00756197|"~     The purpose of this study is to evaluate the safety, feasibility, tissue response, and~     subject side effects of liquid nitrogen sprayed through a catheter (CryoSpray AblationTM,~     CSA or cryospray therapy) via endoscope in subjects with radiation induced proctitis.~   "
214223|NCT00755755|"~     This trial will assess the efficacy and safety of PGL4001 with concomitant iron~     administration versus placebo with concomitant iron administration, over a 3-month period for~     the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding~     due to uterine myoma.~   "
214192|NCT00756171|"~     38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an~     investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing~     the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid~     sequestrant much more potent than cholestyramine but free of adverse effects. It is~     registered as a lipid lowering agent. The intensity of symptoms will be scored by means of~     daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions~     will also be evaluated using quantitative instruments.~   "
214193|NCT00756158|"~     The ultimate goal of this study is to find specific polymorphism of candidate genes~     associated with endophenotypes and/or phenomenological phenotypes of ADHD. We propose to~     replicate the analysis of the candidate genes identified by previous genetic studies on ADHD~     using the candidate gene association study design (family-based case control study using~     parental controls) to validate the findings from other research groups. These results will~     lead our team: (1) to resolve controversies over inconsistent findings in previous genetic~     studies and contribute to the literature on the validity of ASD using clinical and genetic~     data; (2) to study the pathogenetic process of abnormal genes in abnormal neuropsychological~     and neurobiological functions of ADHD; (3) to delineate the nature and the effect of~     gene-gene interaction in the etiology of ADHD.~   "
214194|NCT00756145|"~     Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the~     session. In the present study we compare 3 different methods of injection of LMWH: parameters~     of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each~     patient.~   "
214195|NCT00756132|"~     Women with breast cancer undergo treatments that decrease the chance of recurrence of cancer,~     but are associated with several side effects, including declines in memory and attention and~     other thinking abilities. The causes of these declines are not known. However, we know that~     (i) people with cancer may have high levels of molecules in the blood (cytokines) that~     reflect inflammation; (ii) injection of cytokines into animals, and their use to treat some~     human diseases, can lead to decreased memory and attention; and (iii) in some advanced~     cancers cytokines predict disease outcome. This longitudinal study evaluates the relation of~     cytokines to decreased thinking abilities and to disease outcome over time. Results of this~     study may help develop interventions to prevent or minimize cognitive decline and identify~     women who are at high risk for recurrence, and such information could be used in treatment~     decisions and in the development of new treatment options.~   "
214196|NCT00756119|"~     Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in~     sick patients is important for doctors to better treat these patients. Current procedures~     available demand difficult invasive procedures and hence these parameters are not measured~     with enough frequency and are also limited to certain patients. The new COstatus system is~     capable of using the already existing arterial and venous lines placed in critically ill~     patients and thus provides an opportunity to measure these parameters less invasively and~     with enough frequency.~      The purpose of this study is to measure cardiac output and blood volumes using ultrasound~     dilution technology (COstatus system)in post cardiac surgery adult patients and compare the~     cardiac output measurements with a current clinical reference method, thermodilution.~   "
214197|NCT00756106|"~     RATIONALE: Diagnostic procedures, such as MRI, may help in learning how well radiation~     therapy and chemotherapy work in killing tumor cells and allow doctors to plan better~     treatment.~      PURPOSE: This clinical trial is studying MRI scans to see how well they evaluate the effects~     of radiation therapy and chemotherapy in patients with newly diagnosed glioblastoma~     multiforme or anaplastic glioma.~   "
214198|NCT00756093|"~     To evaluate drop comfort, acceptability and blur profile between four marketed artificial~     tears in dry eye patients~   "
214199|NCT00756080|"~     The specific aim of this study is to determine whether oral citrulline administration~     enhances whole body protein synthesis in healthy humans in the postabsorptive state. Protein~     metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine.~     The investigators hypothesize that citrulline supplementation will decrease leucine oxidation~     without altering proteolysis, and consequently stimulate protein synthesis .~   "
214200|NCT00756067|"~     The purpose of this observer-blind study is to evaluate the safety, reactogenicity and~     immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an~     interval of two months.~   "
214201|NCT00756041|"~     The purpose of this study is to determine the safety of TAK-128, once daily (QD), for~     treatment of diabetic peripheral neuropathy~   "
214202|NCT00756028|"~     Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to~        1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)~        2. quality of life (2. outcome measure)~        3. live birth rate (2. outcome measure)~        4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol~          and vascular endothelial growth factor in follicular fluid(not only compared between~          GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS~          and patients becoming pregnant and not becoming pregnant (2. outcome measure), and~        5. number of oocytes removed per treatment, number of embryo transfers per treatment and~          number of spontaneous abortions per treatment (these three parameters are tertiary~          outcome measures).~      In addition to the above mentioned efficacy outcome measures the safety outcome measure~     frequency of known side-effects will be compared between the two protocols.~   "
214203|NCT00756015|"~     The purpose of this study is to better understand the influence of post-operative~     rehabilitation on the rate of tendon healing and clinical outcomes following arthroscopic~     repair of the rotator cuff. There are two schools of thought on what type of therapy program~     is most beneficial following surgical cuff repair. However there has been little data~     available to compare them. Therefore, the investigators would like to compare these two~     standard plans of care so that the investigators may better define the safety and efficacy of~     early mobilization of the shoulder versus keeping the shoulder immobilized following surgical~     management.~   "
214204|NCT00756002|"~     The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once~     daily (QD), in subjects with chronic insomnia.~   "
214205|NCT00755989|"~     Morphine gel applied topically to wounds will reduce wound pain and decrease patients use of~     oral and intravenous pain medications, therefore reducing side effects.~   "
214206|NCT00755976|"~     RATIONALE: Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving sulindac together with epirubicin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving sulindac together with epirubicin~     works in treating patients with metastatic malignant melanoma.~   "
214207|NCT00755963|"~     Menopausal and postmenopausal women compose almost 20% of the Austrian population. Two thirds~     of all austrian women suffering from depression or anxiety disorders are over 45 years old.~     The serotonergic system, partially regulated by the steroid hormones estrogen and~     progesterone, plays a major role in the pathogenesis and treatment of these illnesses. To~     examine the effect of the hormone replacement therapy on the serotonergic system, twenty-four~     postmenopausal women will be measured using positron emission tomography (PET). The~     volunteers will participate in two PET scans. The first PET scan will be performed right~     before the hormone treatment starts, the second PET scan about 8 weeks after daily treatment~     with (1) a combination of estrogen and progesterone or (2) estrogen and placebo. This imaging~     study hypothesizes that the expression of the main inhibiting serotonergic receptor (the~     serotonin-1A receptor) will be altered by the hormone therapy. The results of the study might~     lead to new strategies in the treatment of psychiatric illnesses during and after the~     menopausal transition.~   "
214208|NCT00755950|"~     The purpose of this study is to assess whether two higher doses (280mg or 420mg three times~     daily)of silymarin therapy are safe and tolerable, and shorten the illness in patients with~     acute viral hepatitis compared to placebo.~   "
214209|NCT00755937|"~     This registry is a multi-center, prospective, observational program that will gather and~     analyze data on subjects with Crohn's disease being treated with Remicade® as per approved~     product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed~     experimental intervention and treatment with Remicade® is determined solely by the subject's~     physicians. Thus, the data captured and reported in this registry will reflect a real world~     approach to the treatment of Crohn's disease with Remicade®.~   "
214210|NCT00755924|"~     This is a double-blinded randomized placebo controlled prospective clinical trial evaluating~     the impact of apple cider vinegar on serum HDL. 112 participants will be randomized to~     consume either 2 tablespoons of vinegar daily or a placebo containing a 2% balsamic vinegar~     solution in water. Baseline, two month and 4 month blood samples will be obtained for fasting~     lipids. The primary endpoint is met if HDL levels increase in the treatment arm versus~     baseline after 2 month intervention.~   "
214211|NCT00755911|"~     The purpose of this research is to determine if a subject's own bone marrow tissue can help~     regenerate bone in the area of his/her jaw where a tooth has been removed using Tissue Repair~     Cell (TRC) Therapy.~   "
214212|NCT00755898|"~     The investigators have determined that the drug amantadine hydrochloride is metabolized by~     acetylation by a specific enzyme named spermidine/spermine N-acetyltransferase (SSAT). This~     enzyme is increased in cancer cells. The investigators hypothesized that the amount of~     N-acetylamantadine excreted in urine during the first 12 hours after an oral dose would serve~     as a diagnostic biomarker for the presence of cancer in a human test subject.~   "
214213|NCT00755885|"~     RATIONALE: Abiraterone acetate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of abiraterone~     acetate and to see how well it works in treating postmenopausal women with advanced or~     metastatic breast cancer.~   "
214214|NCT00755872|"~     This is a randomized, open-label, multi-center, 4-treatment, 4-period crossover study.~     Approximately 72 healthy, surgically sterile or postmenopausal subjects will be enrolled and~     have urine collected over 72 hours following administration of risedronate for all 4~     treatment periods).~   "
214215|NCT00755859|"~     In a previous trial the investigators found that the effect of steroids in IgA nephropathy~     diminish over time. The difference in renal survival is striking up till the third year, but~     then remains constant. A six-month course of steroid therapy may be not enough to ensure a~     stable remission. The investigators hypothesized that a more aggressive treatment may obtain~     long-term better results. The investigators conducted a randomised controlled trial to assess~     the utility of low-dose azathioprine added to steroids in adult IgAN patients.~   "
214216|NCT00755846|"~     The purpose of this study is to determine the safety and efficacy of alogliptin, once daily~     (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of~     sulfonylurea and metformin for treating subjects with type 2 diabetes.~   "
214217|NCT00755833|"~     This study is conducted in Europe. The aim of this observational study is to evaluate the~     blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with~     type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective~     is also to observe the different regimes of starting and maintaining the treatment with~     NovoMix® 50 during one year.~   "
214218|NCT00755820|"~     This is a research study to determine whether a medication called D-cycloserine (DCS) in~     combination with a type of psychotherapy called Exposure Therapy is helpful to patients with~     anorexia nervosa.~   "
214219|NCT00755807|"~     This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg~     once daily (QD) compared with placebo on the reduction of pain severity in participants with~     central neuropathic pain due to Multiple Sclerosis.~   "
214220|NCT00755794|"~     The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium~     (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled~     asthma.~   "
214221|NCT00755781|"~     A Phase III, multi-center, randomized, controlled study designed to demonstrate the efficacy~     and safety of Cyclosporine Inhalation Solution (CIS)in improving survival and preventing~     bronchiolitis obliterans syndrome (BOS) when given prophylactically to lung transplant~     recipients in addition to their standard immunosuppressive regimen.~   "
214222|NCT00755768|"~     The purpose of this study is to determine whether spending more time with a dietitian will~     improve dietary compliance in a group of hemodialysis patients, with particular respect to~     phosphate control.~   "
214268|NCT00755144|"~     This is a prospective Randomised Control Trial to compare the Early Clinical and Functional~     Outcome of the ROCC and LCS total knee arthroplasty implant designs.~   "
214224|NCT00755742|"~     Chronic hepatitis C (CHC) infection affects approximately 1 in 100 Canadians. Untreated, CHC~     has significant long-term consequences including cirrhosis, liver cancer and liver failure.~     CHC is intrinsically linked to both obesity and insulin resistance (IR) or pre-diabetes,~     their co-existence worsens overall health outcomes. We have demonstrated that obesity (BMI~     ≥30kg/m2) is over twice as common amongst patients with CHC (28.8%) compared with the general~     Canadian population. Obesity superimposed on CHC reduces the success of antiviral treatment~     and promotes liver scarring (hepatic fibrosis), fatty liver (steatosis) and increases the~     risk of liver cancer. Both CHC and obesity contribute to IR putting these patients at risk of~     type 2 diabetes. IR, like obesity in CHC, reduces antiviral success rates. We have shown that~     diabetics are at higher risk of developing liver cancer compared with non-diabetics. It is~     therefore timely to address lifestyle modification to delay the onset of diabetes. We will~     examine the impact of a multidisciplinary lifestyle program on the insulin resistance in 52~     obese pre-diabetic patients with current or past CHC. The 24 week program comprises an~     individualized nutritional and exercise plan supported by behavior modification counseling.~     Through gaining a better understanding of links between obesity, insulin resistance and~     hepatitis C infection we hope to delay the onset of diabetes and reduce the likelihood of all~     their untoward effects on the liver.~   "
214225|NCT00755729|"~     The purpose of this study is to delineate the effects of preoperative oral carbohydrate on~     immediate postoperative insulin resistance (PIR) in patients undergoing elective open~     colorectal cancer resection, and to further clarify the hypotheses that preoperative oral~     carbohydrate treatment attenuates PIR in patients by enhancing insulin signaling to~     PI3K-dependent pathway.~   "
214226|NCT00755716|"~     Specific aims:~        1. To obtain pilot data on 4-week continuous quit rates associated with 10 weeks of~          treatment with topiramate or placebo or topiramate plus nicotine patch for smoking~          cessation.~        2. To obtain pilot data on the effects of 10 weeks of topiramate versus placebo versus~          combination of topiramate plus nicotine patch on nicotine withdrawal symptoms, smoking~          satisfaction, and adverse effects during smoking cessation.~        3. To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus~          combination of topiramate plus nicotine patch for smoking cessation.~   "
214227|NCT00755703|"~     The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in~     healthy adults volunteers. Single dose, intranasally administered vaccine using an~     adenovirus-recombinant vector has provided a safe route for inducing protection in animals~     against pandemic influenza in preclinical studies.~      The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.~   "
214228|NCT00755690|"~     This study is designed to describe the physiological response to increased and decreased~     dietary phosphate intake on various parameters of mineral metabolism in the blood and urine~     of individuals with Chronic Kidney Disease stage 3 and 4 with normal serum phosphate levels.~     This detailed study will give us a far greater understanding of the role of diet in abnormal~     mineral homeostasis early in the progression of this chronic disease. The findings of this~     study will help both physicians and dietitians better determine the optimal time to introduce~     dietary therapy in CKD.~   "
214229|NCT00755677|"~     This is a single site, open registration, dietary proof of concept, food substance study~     designed to explore the health benefits associated with daily pulse consumption in~     individuals with peripheral arterial disease. The investigators hypothesis that a diet~     containing at least one serving of pulse crops (dried beans, peas, lentil, chickpeas) per day~     provides flavonoid compounds that improve cardiovascular health by increasing the levels of~     serum adiponectin is based on evidence from the literature that indicates flavonoids present~     in these foods are capable of improving arterial stiffness and reducing hypercholesterolemia.~   "
214230|NCT00755664|"~     The purpose of this study is to evaluate whether low dose complex B-vitamins (folic~     acid,vitamin B6 and vitamin B12) can lower the risk of developing hyperhomocysteinemia in an~     apparently healthy population with low folate/B12 and high Hcy status.~   "
214231|NCT00755651|"~     The investigators have developed a novel instrument for taking endometrial biopsies at no~     touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with~     speculums and tenaculums, and also avoids the possible need for cervical dilatation. The~     investigators wish to study the ease of use and efficacy of the new device compared with~     traditional techniques of endometrial sampling at hysteroscopy.~   "
214232|NCT00755638|"~     Single center, randomized, single dose study to evaluate the safety, tolerability,~     pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers~   "
214233|NCT00755599|"~     This study will determine patient and provider preferences regarding vaginal speculum~     examinations done with and without stirrups.~      Primary research hypothesis: Women undergoing speculum examination will experience at least~     20% less physical discomfort, 20% less sense of vulnerability, and 20% less sense of loss of~     control when using a no-stirrup method of examination compared to traditional in-stirrup~     examinations.~      Secondary research hypothesis: 25% or less of the providers taught this alternative method of~     speculum examination will find it to be unacceptable.~   "
214234|NCT00755586|"~     The purpose of this study is to assess muscle improvement after stem cell injection in the~     biceps muscle of patients with a brachial plexus injury.~   "
214235|NCT00755573|"~     The aim of the study is to investigate the effect of pregabalin in pain resulting from~     chronic pancreatitis. The effect will be investigated by means of questionnaires concerning~     the daily experience of pain and the general quality of life. Furthermore the patients will~     be invited to participate in experimental testing with a multimodal pain model. The~     experimental testing will include stimulation of the skin, muscle and visceral tissue. The~     results from the experimental part of the study may help us to understand the mechanisms of~     action of pregabalin in this patient population.~   "
214236|NCT00755560|"~     The purpose of this study is to evaluate effectiveness of albendazole in the treatment of the~     asymptomatic infection with the parasite Toxocara in children. Treatment response is defined~     as a reduction in the number of eosinophils in blood. The study drug will be compared to~     placebo and randomly assigned in a double blind manner. Follow up will be prospective. 50~     children (25 per group) will be enrolled in the study.~   "
240277|NCT00409890|"~     To determine whether hyoscine butyl bromide is effective in shortening the first stage of~     labor, with no increase in maternal or neonatal complications.~   "
214237|NCT00755547|"~     Background:~      The investigators know that exercise helps children develop strong bones and muscles and~     generally stay healthy. What is unclear however, is how much exercise a child needs to lower~     their risk of developing type 2 diabetes.~      Objective:~      The investigators will try to find out whether high-intensity exercise for a short-period of~     time is better than moderately intense exercise for improving the diabetes risk profile in~     teens who are at risk for type 2 diabetes.~      The working hypothesis is that exercise-mediated improvements in insulin sensitivity (a risk~     factor for diabetes) will be greater following vigorous intermittent physical activity than~     following low intensity physical activity in overweight adolescents 13-18 yrs at risk for~     T2DM.~      Brief Description of Research Project: Teenagers between the ages of 13 and 18 yrs, who are~     at risk for type 2 diabetes (either by their family history or an abnormal response to sugar)~     will be randomly assigned to one of two activity groups or a control group. The activity~     groups will have supervised exercise sessions 3 to 5 days per week for 6 months. One group~     will do high-intensity exercise, and the other will do lower-intensity exercise. We will~     measure how sensitive their body is to insulin and the amount of fat in their muscle and~     liver tissue at the beginning and end of the exercise intervention.~   "
214238|NCT00755534|"~     This phase II study will evaluate which is the best way to administer cetuximab after~     recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the~     efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment.~   "
214239|NCT00755521|"~     The main of the proposed study is to assess whether the use of the Cox-2 inhibitor Etoricoxib~     is beneficial for the use in fibromyalgia. We intend to seek whether this medication may~     improve psychiatric and rheumatologic parameters of the disease.~   "
214240|NCT00755508|"~     The purpose of this study is to determine the efficacy and safety of ramelteon, once daily~     (QD), taken in combination with Gabapentin for treating insomnia.~   "
214241|NCT00755495|"~     The purpose of this study is to determine the efficacy of ramelteon, once daily (QD),~     combined with doxepin in treating subjects with insomnia.~   "
214242|NCT00755482|"~     The objective of this trial is to evaluate the effect of Aquamin F versus placebo on NSAID~     (non-steroidal anti-inflammatory drug) dose reduction in subjects with osteoarthritis of the~     knee.~      Hypothesis 1: After 12 weeks of treatment, subjects taking Aquamin F will use significantly~     less NSAID medications for symptoms of osteoarthritis versus placebo alone.~      Hypothesis 2: No significant differences will be seen for adverse events between the subjects~     taking Aquamin F or placebo.~   "
214243|NCT00755469|"~     When angioplasty (PTCA) and stenting of the blood vessels of the heart is the treatment for a~     Heart Attack, there is damage to the heart muscle that is caused by the sudden opening of the~     blood vessels. This is called reperfusion injury. The cell death is due to inflammation and~     the generation of free radicals.~      The primary objective of this study is to determine if post-conditioning(four brief (30~     second) PTCA balloon inflations) reduces damage to the heart muscle. This will be measured by~     heart enzyme tests-CK measurements- and by cardiac MRI.~   "
214244|NCT00755456|"~     The current study is initiated in order to assess the impact of a PD solution containing~     L-carnitine on insulin sensitivity measured by a hyperinsulinemic euglycemic clamp.~   "
214245|NCT00755443|"~     The purpose of this study was to determine whether Sirolimus stent implantation is effective~     in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with~     de novo coronary artery stenosis.~   "
214246|NCT00755430|"~     Autism spectrum disorder (ASD) has been given a high priority for genetic and neurobiological~     study. There is no such information in Asian population and no study has conducted using~     Diffusion Spectrum Imaging (DSI) to investigate the connectivity throughout the world.~     Moreover, no follow-up study has been done to examine the developmental changes of structural~     and functional connectivity. We anticipate to establishing a cohort of 50 ASD and their~     siblings with complete clinical, neuropsychological, brain imaging, and genetic data for~     longitudinal study on ASD. Our findings will contribute to our understanding of the~     structural and functional dysconnectivity for ASD and whether dysconnectivity can be an~     endophenotype for ASD and used as a biomarker for early diagnosis of ASD.~   "
214247|NCT00755417|"~     Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release~     formulation of gabapentin that is being studied for the treatment of hot flashes in~     postmenopausal women.~   "
214248|NCT00755404|"~     The current study is initiated in order to assess the impact of a PD solution containing~     L-carnitine on insulin sensitivity evaluated by measuring insulin requirement.~   "
214249|NCT00755391|"~     This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy~     (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.~   "
214250|NCT00755378|"~     This is a study to evaluate safety, tolerability, PK and PD effects of orally administered~     AZD8529 after single ascending doses~   "
214251|NCT00755365|"~     Mortality associated with pelvic fractures resulting from blunt trauma ranges between 6 and~     18%. In cases where hemodynamic instability is also present, the mortality rate is~     significantly greater, and has been reported as high as 60%. There is no general consensus~     among traumatologists as to the initial management of this complicated subgroup of patients.~     It is largely debated whether emergent orthopedic fixation or angiographic embolization~     should be the first line of treatment for pelvic hemorrhage~   "
214252|NCT00755352|"~     Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and~     lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least~     4 weeks.~   "
214269|NCT00755131|"~     This purpose of this study is to examine the relationship between HMGB-1 and postinfarction~     predictors of outcome such as cardiopulmonary and echocardiographic parameters before and~     after a 6-month exercise-based cardiac rehabilitation program.~   "
214270|NCT00755118|"~     The aim of this study is to evaluate the efficacy of the effective drugs in a alternating~     chemotherapy schedules in pretreated patients with mCRC, who have received all effective~     drugs.~   "
214271|NCT00755105|"~     This is an observation study of subjects who previously had iron-55 isotope administered in~     studies of iron absorption. By determining the retention of the isotope in blood during a~     3-year period, body iron excretion can be measured.~   "
214253|NCT00755339|"~     This study will investigate the sensation that many people with Tourette syndrome (TS)~     experience before they have a motor tic. It will also test whether blocking the sensation~     causes the tic to stop.~      People between 18 and 65 years of age with TS who have at least once tic involving an arm may~     be eligible for this 3-part study. Those enrolled may participate in all parts or in part 1~     or part 2. Those who choose to participate in part 3 must first complete part 2. All must~     stop taking medication for TS and any other medication that may affect the brain for at least~     1 week before the study.~      Part 1~      After numbing the skin or muscles of the arm or leg where a pre-tic sensation is experienced,~     the response of the nerves will be tested by asking subjects to rate the strength of the~     sensation after a pinprick and by stimulating the nerves with small electrical shocks. Then,~     over the course of approximately one hour, subjects will report pre-tic sensations while~     their motor tics are counted. The onset of each tic will be identified with EMG, a test using~     electrodes on the skin to indicate the activity of the muscles.~      Part 2~      Subjects brain waves are recorded using magnetoencephalography (MEG) while they are~     experiencing tics andpre-tic sensory experiences. MEG is a test that records magnetic field~     changes produced by brain activity. Subjects sit in a chair under a dome containing magnetic~     field detectors. They watch a clock and report the time a sensory experience starts. Tics are~     recorded with EMG. Later, a standard MRI of the brain (scan using a magnetic field and radio~     waves) is done to see which parts of the brain produced the activity recorded with MEG.~      Part 3~      Repetitive transcranial magnetic stimulation (rTMS) is used to try to stop the pre-tic~     sensations. For TMS, the subject sits in a chair. A wire coil is held on the subject s scalp,~     and a brief electrical current is passed through the coil, creating a magnetic pulse that~     stimulates a region of the brain. The goal of this stimulation is to reduce the sensory~     experience that precedes a tic in one region of the body. During stimulation, the subject~     hears a click and may feel a pulling sensation on the skin under the coil. There may be a~     twitch in the muscles of the face, arm or leg. This study uses a pattern of repeated pulses~     delivered in short bursts. Following each train of pulses, the effect of the stimulation on~     sensation will be tested by asking the subject to rate the strength of a pinprick and of a~     vibration. In addition, the nerves are stimulated with small shocks to evaluate the effect of~     the TMS on nerve activity. To determine the effect of TMS on the pre-tic sensation, subjects~     are asked to watch a clock and report when they are having a sensory experience. The effect~     on motor tics will be evaluated by using EMG to indicate the tics.~   "
214254|NCT00755326|"~     The purpose of this study is to determine if the traditional Chinese herbal compound~     (Huo-Luo-Xiao-Ling Dan, or HLXL) is effective in treating OA of the knee in addition to~     participants current OA of the knee treatment(s) and also to determine the best dosage of~     HLXL that is safe and well tolerated.~   "
214255|NCT00755313|"~     RATIONALE: Gathering information over time from laboratory tests, imaging scans, and~     assessment tests may help doctors learn more about the side effects of chemotherapy and plan~     the best treatment.~      PURPOSE: This clinical trial is studying the effects of chemotherapy on the brain in women~     with newly diagnosed early-stage breast cancer.~   "
214256|NCT00755300|"~     In patients undergoing total knee arthroplasty, thromboembolism is a common occurrence,~     especially following tourniquet deflation. The resulting cardiopulmonary emboli can~     potentially lead to hypoxemia, hypotension, hemodynamic collapse and post operative cognitive~     dysfunction due to emboli. The standard surgical technique involves placing an intramedullary~     rod in the femur to determine the angle and degree of resection from the end of the femur. A~     new surgical technique utilizes computer navigation system to perform the desired cuts in the~     appropriate position. The investigators hypothesize that the avoidance of intramedullary~     instrumentation in computer assisted total knee replacement will result in fewer~     thromboembolic events compared with the standard technique using manual instrumentation in~     the femur. The present study will test this hypothesis by quantifying the extent of~     thromboembolism during both surgical techniques.~   "
214257|NCT00755287|"~     This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared~     to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately~     controlled with metformin and sulphonylurea combination therapy. Patients will be randomized~     to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg~     once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to~     continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years,~     and the target sample size if 500+ individuals.~   "
214258|NCT00755274|"~     Primary Objective:~      To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from~     healthy children receiving the 2008-2009 formulation of the inactivated, split-virion~     influenza vaccine Fluzone® for further study.~      Observational Objectives:~      To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine,~     administered in a one- or two-dose schedule in accordance with Advisory Committee on~     Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.~      To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine,~     administered in a one- or two-dose schedule in accordance with ACIP recommendations, in~     children ≥ 6 months to < 5 years of age.~   "
214259|NCT00755261|"~     This research is being done to find out if adding a drug called Avastin to an already~     approved regimen used for soft-tissue sarcoma, Doxorubicin, will improve overall survival,~     and slow disease progression. The study will also evaluate the overall safety of combining~     these drugs. It is not known if combining these drugs will improve outcome. Avastin has been~     approved for the treatment of metastatic carcinoma of the colon or rectum. It is not approved~     for the treatment of soft-tissue sarcoma when added to Doxorubicin.~   "
214260|NCT00755248|"~     The purpose of this study is to determine the relations between conventional and~     unconventional risk factors and adverse clinical events at follow-up (including coronary~     bypass patency) in patients undergoing surgical myocardial revascularization.~   "
214261|NCT00755235|"~     This study will test whether an electronic system that monitors and sends messages to help~     people with depression could be feasible, acceptable, and potentially effective as a~     treatment.~   "
214262|NCT00755222|"~     This study evaluated the safety and effectiveness of AA4500 in improving the impact of~     Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's~     disease~   "
214263|NCT00755209|"~     The study's objective is to evaluate the effectiveness and safety of tranexamic acid for~     adult patients with moderate to severe TBI.With the research question as Does TXA reduce the~     incidence of progressive intracranial haemorrhage by 50% compared to placebo in moderate to~     severe adult TBI patients at Khon Kaen Hospital?~   "
214264|NCT00755196|"~     The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%,~     compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque~     type psoriasis~   "
214265|NCT00755183|"~     The objective of this study is to assess the safety and efficacy of testosterone 0.03%~     ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.~   "
214266|NCT00755170|"~     This trial will evaluate the efficacy and safety of metronomic vinorelbine and bevacizumab~     combination in patients with pretreated, advanced non small cell lung cancer~   "
214267|NCT00755157|"~     This trial will evaluate the efficacy and safety of metronomic docetaxel and bevacizumab~     combination in patients with pretreated, advanced small cell lung cancer.~   "
214272|NCT00755092|"~     Psychological care during labor is considered as an important supplemental procedure for~     alleviating delivering stress and pain. Although Doula has been recommending that should be~     given for parturients, its precise effect on nulliparous and multiparous women is still~     unknown. The investigators hypothesized that multiparas had experienced the process of labor,~     but the nulliparas were not, so Doula support would produce different effect on these two~     population.~   "
214273|NCT00755079|"~     The primary purpose of this study is to determine the effect of administration of the oral~     beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with~     cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings~     with those obtained in a demographically matched group that will receive placebo.~     Participation in this study will involve 12 weeks of pharmacological intervention during~     which participants will be randomized to receive either oral albuterol 4mg twice daily or~     placebo. All investigators and study participants will be blinded to randomization by our~     research pharmacy. Participation in the study will require study subjects to come to our lab~     for the total of 2 visits (at baseline and after week 12), during which a series of tests~     will be performed to assess their respiratory muscle strength and pulmonary function.~   "
214274|NCT00755066|"~     Evaluation of the effect of fluticasone propionate vs placebo applied as nasal spray on the~     increase of allergen-specific serum IgE levels following nasal exposure to recombinant~     allergens. Nasal sprays will be applied for four weeks starting two weeks before nasal~     provocation and serum IgE levels will be followed during eight weeks after nasal provocation.~   "
214275|NCT00755053|"~     The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not~     inferior to the old Canesten formulation (tablet)~   "
214276|NCT00755040|"~     RATIONALE: Cyclosporine eye drops may prevent graft-versus-host disease of the eye in~     patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow~     failure disorder.~      PURPOSE: This randomized phase I trial is studying how well cyclosporine eye drops work in~     preventing graft-versus-host disease of the eye in patients who have undergone donor stem~     cell transplant for hematologic cancer or bone marrow failure disorder.~   "
214277|NCT00755027|"~     The purpose of this study is to determine whether rasagiline is effective in the treatment of~     apathy in patients with Parkinson's disease.~   "
214278|NCT00755014|"~     Light-to-moderate alcohol consumption has been associated with a reduction of cardiovascular~     events, and red wine seems to offer more benefits than any other type of alcoholic beverages.~     However, the relationship between red wine consumption and endothelial progenitor cells~     (EPCs) remains unclear. The investigators examine whether intake of red wine could enhance~     the number or functional capacity of circulating EPCs by upregulation of nitric oxide (NO)~     bioavailability.~   "
214279|NCT00755001|"~     This post market study intends to evaluate the safety and the performance of BiHapro Total~     Hip System with two types of coatings.~   "
214280|NCT00754988|"~     This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared~     to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled~     with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg~     once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or~     placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment.~     After 24 weeks of treatment, patients on active treatment will continue on the same treatment~     and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide~     20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on~     study treatment is 2+ years, and the target sample size is 500+ individuals.~   "
214281|NCT00754975|"~     Prospective, multi-center, randomized trial. A maximum of 130 patients will be enrolled, in a~     2:1 ratio to receive either the JACTAX LD stent or the TAXUS™ Libertè™ stent to evaluate the~     efficacy of the product.~   "
214282|NCT00754962|"~     The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets~     under fasted conditions~   "
214283|NCT00754949|"~     The purpose of this study is to determine if AzaSite Plus is effective and safe for the~     treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.~   "
214284|NCT00754936|"~     The purpose of this study is to examine the relationship between brain electrical activity in~     elderly depressed patients and response to antidepressant medication treatment. Elderly~     patients with depression will be treated for 12 weeks with an antidepressant medication~     commonly used in clinical practice called escitalopram (Lexapro). Brain electrical activity~     will be assessed using electrophysiological tests. Researchers are interested in whether the~     brain electrical activity of elderly people with depression before they start the medication~     can tell us who amongst them will improve with antidepressant treatment and to what extent.~     They will also determine whether patients' brain electrical activity during the 12 weeks of~     medication treatment will change in any way and whether this change will be linked with a~     change in the severity of their depression. Researchers hope that information gained from~     this study will help to better understand the brain processes associated with depression and~     its successful treatment.~   "
214285|NCT00754923|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or~     former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung~     cancer.~   "
214286|NCT00754910|"~     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a~     certain kind of light. When the drug is active, cancer cells are killed. This may be~     effective against non-small cell lung cancer.~      PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium~     works in treating patients with non-small cell lung cancer and bronchial disease.~   "
214287|NCT00754897|"~     We have been asked to participate in the Pediatric Anesthesia NeuroDevelopmental Assessment~     Study (PANDAS), which is a study to compare neurocognitive functions in sibling pairs: one of~     whom had exposure to anesthesia during inguinal hernia surgery before three years of age~     (exposed) and the other who was not exposed to anesthesia or surgery in the first three years~     of life (unexposed). A consortium of approximately 6 hospitals is doing this feasibility~     study to determine if there is an adequate number of subjects for each of the two age groups~     before the formal study begins.~   "
214289|NCT00754871|"~     This study will be investigated what mechanism of action Dienogest has. The growth of the~     follicles, the endometrium, the hormones in the blood and the mucus that is produced by the~     cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and~     3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72~     days.~   "
214290|NCT00754858|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving belotecan together with cisplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well belotecan works when given together with~     cisplatin in treating patients with previously untreated extensive stage small cell lung~     cancer.~   "
214291|NCT00754845|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is~     not yet known whether letrozole is more effective than a placebo in treating in women with~     breast cancer who have already received 5 years of aromatase inhibitor therapy.~      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works~     compared with a placebo in treating women with primary breast cancer who have received 5~     years of aromatase inhibitor therapy.~   "
214292|NCT00754832|"~     This research project will determine the safety and tolerability of ginseng in subjects with~     MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment~     of MS fatigue.~   "
214293|NCT00754819|"~     The purpose of this study is to evaluate the effect of colchicine on high sensitivity~     C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute~     coronary syndromes.~   "
214294|NCT00754806|"~     ABSTRACT~      Background: Although there are some comparative studies between laparoscopy and hand-assisted~     laparoscopic splenectomy (HALS) in splenomegaly cases, there is no study of the differences~     between HALS and open splenectomy (OS). Our aim was to compare the HALS and OS techniques in~     splenomegaly cases.~      Methods: This prospective study included 27 patients undergoing splenectomy for splenic~     disorders at the Department of General Surgery, Istanbul Medical Faculty between February~     2007 and October 2007. OS was performed on 14 patients, and HALS was performed in the other~     13 patients.~      Key words: HALS, open splenectomy, splenomegaly~   "
214295|NCT00754793|"~     The study hypothesis is that the addition of an antidepressant to the standard treatment~     regimen in patients with both chronic sinusitis and depression or facial pain disorders and~     depression will decrease the report of chronic sinusitis or facial pain symptom severity.~      This is a stratified, randomized, double-blind, placebo-controlled study using the drug~     escitalopram for the treatment of depression in patients experiencing depression and chronic~     sinusitis or depression and facial pain disorders.~      It is a 12-week study. Subjects will have a screening visit and then be followed up by phone~     weekly for four weeks and bi-weekly for 8 weeks.~   "
214296|NCT00754780|"~     The study is a phase II, open label trial of oral Pirfenidone in 24 adult patients with~     neurofibromatosis type 1.~      Pirfenidone is a new, broad-spectrum anti-fibrotic drug, with proven in vitro and in vivo~     negative effects on fibroblast growth and collagen matrix synthesis. Human studies indicate~     promising therapeutic effects in arresting and reversing fibrosis in a variety of different~     conditions, where the excessive formation of fibrous tissue is a major pathogenic mechanism.~     Since the fibrous tissue is a significant component of neurofibroma, reduction of fibrosis~     could diminish tumor progression and lead to tumor shrinkage. Therefore, Pirfenidone is an~     excellent candidate for the treatment of plexiform neurofibromas and surgically unresectable~     tumors in patients with NF1.~   "
214297|NCT00754767|"~     RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy.~      PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in~     preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast~     cancer.~   "
214298|NCT00754754|"~     The purpose of this study is to utilize a sensor incorporated into a brain retractor blade to~     monitor electrical activity and pressure applied to the brain during retraction required for~     the selected skull base operations. The overall goal of the study is to develop a protocol~     and guidelines to prevent the development of brain retraction injury during neurosurgical~     procedures requiring significant retraction.~   "
214299|NCT00754741|"~     The purpose of this study is to compare the effectiveness of two different interventions to~     improve adherence to diabetes medications among patients with diabetes and poor metabolic~     control.~   "
214300|NCT00754728|"~     Prospective, multi-center, non-randomized registry. 100 patients will be enrolled at up to 10~     clinical sites in Europe. The results of this study will be compared to the TAXUS™ ATLAS~     clinical trial to evaluate the safety of the product.~   "
214301|NCT00754715|"~     The primary purpose of this study is to assess the safety and tolerability of AZD2516~     following administration of a single dose.~   "
214302|NCT00754702|"~     The purpose of this study is to evaluate the safety and efficacy of metronomic oral~     vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment~     in patients with metastatic breast cancer.~   "
214303|NCT00754689|"~     The primary objective of the study is to demonstrate superiority of rimonabant/metformin~     combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single~     agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9~     months.~      The secondary objective is to investigate the effects of rimonabant/metformin combinations~     for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density~     Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months.~      Another objective is to evaluate the safety of rimonabant in combination with metformin over~     a period of up to 52 weeks.~   "
214304|NCT00754676|"~     The prospective sham randomized study will evaluate the role of endoscopic stenting~     inpatients with chronic pancreatitis and chronic abdominal pain.~   "
214319|NCT00754468|"~     The purpose of this study is to evaluate the treatment effect, depth of injury, and side~     effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray~     AblationTM, CSA or cryospray therapy) onto healthy tissue via esophagogastroduodenoscopy~     (EGD) using surgical resection specimens from subjects undergoing esophagectomy.~   "
214305|NCT00754663|"~     Exercise therapy has proven to be an effective additive therapy in patients with~     cardiovascular diseases. The prognostic value of physical activity is well established in~     patients with congestive heart failure. Therefore the investigators assumed that the~     population of patients with implantable cardioverter-defibrillators (ICD) with impaired left~     ventricular function may also benefit from a cardiovascular training in terms of improved~     quality of life and reduction of ventricular arrhythmia. The data on feasibility, risk and~     therapeutic effects of exercise training are very limited or not available.~      This prospective randomized study examines the feasibility and benefits of exercise therapy~     in patients with ICD and congestive heart failure.~   "
214306|NCT00754650|"~     This single arm study evaluated the bone marrow response, safety, and tolerability of 6~     months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic~     leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with~     6 months of follow-up.~   "
214307|NCT00754637|"~     The purpose of this prospective clinical data-collection is to document the performance and~     clinical outcomes of the Microplasty Tibial Tray.~   "
214308|NCT00754624|"~     Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005~   "
214309|NCT00754611|"~     What is the course of migraine headache recurrence, how is it managed, what characteristics~     are associated with it, and how does it influence patient satisfaction with treatment?~   "
214310|NCT00754585|"~     Back pain and chair use are the second most important health factors for the aging workforce.~     Besides personal suffering, postural discomfort in the workplace reduces performance and~     productivity, both of which can be improved by raising comfort levels. In an attempt to~     improve comfort and reduce injury risk, ergonomic chairs are commonly equipped with lumbar~     supports in an attempt to support a neutral spine. However, people often alter their~     position when such a device is in place as they arch their back to conform to it. The Logic~     Back support offers a simple means to alter posture and reduce associated strain on the lower~     back during seated tasks by supporting the Effortless Neutral Position or the natural~     curvature of the low back. Although it has been used clinically by many practitioners, its~     effectiveness has yet to be shown by scientific study. The current work will help to~     understand if and why the Logic Back is effective and how it can become a low-cost solution~     to reduce the discomfort of those suffering from low back pain.~      The purpose of this study is to determine the effectiveness of the Logic Back and the~     Effortless Neutral Position in improving comfort and functional performance during seated~     tasks, as compared to a standard, ergonomic chair.~   "
214311|NCT00754572|"~     This single arm, open-label study will assess the safety and efficacy with regar d to~     reduction of signs and symptoms of treatment with tocilizumab in combinatio n with~     methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will~     receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The~     anticipated time on study treatment is 3-12 months, and th e target sample size is <500~     individuals.~   "
214312|NCT00754559|"~     This single arm study will assess the effectiveness of tocilizumab in combination with~     traditional DMARDs with regard to the clinical improvement in disease activity (achievement~     of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have~     had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients~     will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable~     pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular~     treatment period and a further 6 infusions during an optional extension phase. The~     anticipated time on study treatment is 6 to 12 months, and the target sample size is <500~     individuals.~   "
214313|NCT00754546|"~     Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus~     than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with~     COPD. The hypothesis of the study is that patients with COPD will exhibit greater~     improvements in exercise endurance and breathlessness with arformoterol compared with normal~     saline during treadmill walking than with cycle exercise.~   "
214314|NCT00754533|"~     The benefits of cardiac rehabilitation have been clearly demonstrated. In particular exercise~     training is recognized to be part of modern management after coronary artery disease. However~     methods of prescribing exercise-training programs and the exercise intensity are difficult to~     determine. The objective of this randomised clinical trial is to determine whether~     appropriate endurance exercise training improves the ventilatory threshold, the exercise~     tolerance and the quality of life in patients with coronary artery disease. Patients are~     randomized to continuous training or aerobic interval training respectively: 80%-versus~     maximal-workload at the ventilatory threshold. For each patient, the intensity of exercise~     training is determined by a first exercise test with gas analysis using parameters of sub~     maximal exercise capacity such as ventilatory threshold. Others parameters of functional~     capacity are also considered. Duration of the rehabilitation stage is between 7 to 10 weeks.~     Dyspnoea assessment at maximal intensity, quality of life measurement by SF36, drugs and~     events are reported. Maximal exercise tests with gas exchange measurements are performed~     after training program and at 6 months follow-up to compare the different cardio respiratory~     parameters in the two groups before and after exercise training and to evaluate the more~     effective endurance training program.~   "
214315|NCT00754520|"~     The aim of this study is to demonstrate the non-inferiority of the ceramic on metal~     articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same~     cup.~   "
214316|NCT00754507|"~     To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins,~     and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at~     least 4 weeks.~   "
214317|NCT00754494|"~     This randomized phase II trial is studying how well erlotinib hydrochloride works in treating~     patients with stage I-III colorectal cancer or adenoma. Erlotinib hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking~     blood flow to the tumor. Erlotinib hydrochloride may also stop tumors from growing or coming~     back~   "
214318|NCT00754481|"~     The investigators hypothesize that, following cardiac arrest in pediatric patients,~     hypothermia therapy will improve the proportion of patients with a good functional outcome~     compared to a normothermic control group.~   "
214347|NCT00754104|"~     Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors~   "
214320|NCT00754455|"~     A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and~     Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in~     Healthy Adults.~      Study Objectives:~      Primary:~        -  To assess the tolerability and safety of Influenza VLP Vaccine~        -  To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination~          inhibition (HAI) antibody titers to each of the three component viral strains~      Secondary:~        -  To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by~          hemagglutination inhibition (HAI) antibody titers against drifted strains~        -  To quantify antibody against neuraminidase and hemagglutinin following administration of~          Influenza VLP Vaccine~        -  To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine as quantified by~          interferon-gamma (IFNg) and Granzyme-B produced by peripheral blood mononuclear cells~          (PBMCs).~   "
214321|NCT00754442|"~     The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which~     activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary~     hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected~     group of young patients with normal kidney function.~   "
214322|NCT00754429|"~     To compare the effect of losartan vs amlodipine-based antihypertensive therapy on~     atherosclerotic inflammatory markers and cerebrovascular regulation in Ischemic stroke~     patients.~   "
214323|NCT00754416|"~     This observational study intends to collect efficacy and safety data on S.E.S shoulder system~   "
214324|NCT00754403|"~     The purpose of this study is to determine the efficacy of pioglitazone and metformin~     combination therapy, once daily (QD), on glycosylated hemoglobin in adults with type 2~     diabetes.~   "
214325|NCT00754390|"~     This study is determine the effects of dietary calcium and phytate on zinc absorption.~   "
214326|NCT00754377|"~     The Accreditation Council for Graduate Medical Education (ACGME) acknowledged the changing~     needs of physicians in training when it endorsed practice-based learning and improvement~     (PBLI) -- a competency that is typically omitted from medical curriculum. The goal is to have~     residents competent to investigate and evaluate their own patient care practices, integrate~     scientific evidence and be able to improve their practices. Available assessment tools do not~     adequately address all of the components of PBLI and few assessment tools attempt to capture~     the residents' ability to develop and implement clinically-based Continuous Quality~     Improvement (CQI) projects that involve the practice setting. Curriculums without such foci~     miss the importance of system perspectives and opportunities for interprofessional team~     development. Our aim is to evaluate preliminary data on the curriculum we developed to~     address the gaps, to develop an assessment tool, and to provide methods for assessing the~     sustainability of system projects.~      The key component of the curriculum is the integration of system quality improvement~     projects. PBLI curriculum was offered on alternate rotations. Preliminary data is available~     from 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42). Data includes~     closed- and open-ended questions designed to assess resident PBLI application skills, the~     notes and presentation slides for the residents' presentation.~   "
214327|NCT00754364|"~     Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single~     agent chemotherapy regimens. A significant proportion of these patients will be elderly (70~     years of age) and many oncologists would consider intravenous vinorelbine or gemcitabine to~     be the standard of care in this patient population. It has been demonstrated that single~     agent vinorelbine offers therapeutic advantages to selected NSCLC patients over best~     supportive care alone.~      Carboplatin plus Alimta have an acceptable toxicity profile and few clinical problems so it~     could be acceptable its use in elderly patients.~      A randomised study is being performed therefore to assess whether progression free survival,~     the primary efficacy endpoint for this study, achieved with Carboplatin plus Alimta is~     superior than achieved with gemcitabine, one of the current standards of care in elderly~     patients with advanced NSCLC.~   "
214328|NCT00754351|"~     This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab~     combination, administered biweekly, as salvage treatment in patients with metastatic and HER2~     negative breast cancer.~   "
214329|NCT00754338|"~     The purpose of this study is to determine if reduced lens deposits and increased comfort can~     be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in~     conjunction with an intensive cleaner, rather than using MPDS in a rub format.~   "
214330|NCT00754325|"~     The purpose of this study is to find out what effect the combination of fulvestrant~     (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant~     alone.~   "
214331|NCT00754312|"~     The primary objective of the study is to evaluate changes in the expression of targeted~     biomarkers in invasive breast cancer tissue before and after SNDX-275 administration.~   "
214332|NCT00754299|"~     The Study Investigators have seen high rates of tobacco cessation success combining Chantix~     with the risk of no surgery, should tobacco use continue. Once patients achieve tobacco~     cessation and undergo surgery, the investigators have seen high rates of union and/or~     infection resolution. The investigators are looking to document and publish these~     observations. To date, no studies have been published that have examined the effects of this~     type of protocol on short and long-term tobacco cessation.~      The investigators want to examine and report the outcome of Hershey Medical Center's~     Orthopaedic Trauma Division's protocol for two endpoints: 1) pre-op tobacco cessation and 2)~     duration of tobacco cessation. This protocol involves counseling, Chantix, and a 'no-surgery'~     risk. Patients will be followed postoperatively for success and duration of tobacco~     cessation, as well as for fracture union and/or infection eradication.~   "
214333|NCT00754286|"~     Aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety~     and increase quality of life in cancer patients. Therefore, the proposed study aims to assess~     the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of~     life among pediatric oncology patients receiving emetogenic chemotherapy.~   "
214334|NCT00754273|"~     To determine the prevalence of MRSA isolates with marginal susceptibility to vancomycin or~     heteroresistance.~   "
214348|NCT00754078|"~     The hypothesis is that helical tomotherapy could minimize radiation related toxicity by~     avoiding or limiting doses to structures such as small bowel, external genitalia, skin,~     bladder, rectum, and femoral neck and head.~   "
214335|NCT00754260|"~     A. Statement of Objective: To conduct a randomized trial to evaluate the impact of caffeine~     restriction on Overactive Bladder(OAB) symptoms including urinary frequency, nocturia,~     incontinence episodes, symptom severity and bother and quality of life.~      B. Specific Aims/Hypothesis:~        1. To determine if reduction in caffeine intake decreases urinary frequency, nocturia and~          incontinence episodes as measured on a 3-day voiding diary in women with Overactive~          Bladder (OAB).~           We hypothesize that women with overactive bladder will report less frequent urination~          and decreased nocturia and incontinence episodes with caffeine reduction.~        2. To determine whether caffeine reduction results in decreased symptom severity and bother~          and improved quality of life scores as measured by the Questionnaire for Incontinence~          Severity Index (ISI), Questionnaire for Urinary Incontinence Diagnosis (QUID),~          Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7).~      We hypothesize that women with OAB who reduce their intake of caffeine will report decreased~     symptom bother and improved quality of life as measured by the ISI, UDI-6 and the IIQ-~   "
214336|NCT00754247|"~     Keloids are thought to result from derailments in the typical wound healing process following~     cutaneous injury. Current treatment options for keloids include intralesional~     corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery,~     including radiation and cryotherapy.~      0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely~     used over-the-counter medications for the treatment of keloids and hypertrophic scars.~     However, their efficacy and safety have not been compared in a blinded, placebo-controlled,~     prospective fashion. This study is being undertaken to determine the efficacy and safety of~     HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and~     keloids.~      This is an investigator-blinded study, which means that the doctor evaluating you will not~     know if you are receiving the study medication or not. Another doctor will be supplying you~     with the medication and discussing any problems that you may have with the medication.~      You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be~     assigned by chance and you will have two in three chances of receiving treatment with a study~     medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no~     active ingredients such as steroids, silicone, vitamin E, or onion extract.~   "
214337|NCT00754234|"~     This study will measure nonheme iron absorption from each of the 7 daily MyPyramid menus.~     Such measurements will confirm whether modifications are needed to meet dietary iron~     recommendations and will provide data useful for validation algorithms to calculate dietary~     iron bioavailability.~   "
214338|NCT00754221|"~     This is a study to investigate the long-term safety and effectiveness [S,S]-Reboxetine in~     relieving the symptoms of Fibromyalgia in patients.~   "
214339|NCT00754208|"~     This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in~     treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children.~     Virtually no data has been published on the use of long-acting stimulant preparations in very~     young children despite early symptomatic development in a significant portion of young~     children with ADHD. This would be one of the first studies looking at a long-acting~     preparation of a stimulant medication in the treatment of ADHD in very young children.~      Hypotheses~        1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.~        2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old~          children.~   "
214340|NCT00754195|"~     This study is designed to compare thoracic epidural catheter insertion distances, in order to~     determine which is the best for pain relief following a thoracotomy.~      HYPOTHESIS :~        1. The quality of epidural analgesia upon coughing one hour following the end of surgery~          will not be inferior if the catheter is inserted 7 cm in the epidural space, versus 3~          and 5 cm.~        2. The quality of epidural analgesia upon coughing at 24 hour will not be inferior if the~          catheter is inserted 3 cm in the epidural space, versus 5 and 7 cm.~   "
214341|NCT00754182|"~     The aim of this study is to compare aesthetic results of two different type of sutures~     (subcuticular versus synthetic glue) in post-thyroidectomy incisions. It is a randomized~     clinical trial (single blinded) designed as a superiority study, since in the authors'~     hypotheses glue can give better results compared with subcuticular suture in this particular~     district. Secondary objective is to investigate if other factors (like the use of cold/warm~     blade, the sex, the presence of diabetes, the lenght of incision) can influence aesthetic~     results.~   "
214342|NCT00754169|"~     This study will examine the long-term outcome of brain injuries, the effects of treatment on~     outcome and the effects of brain injury on people s behavior and abilities.~      Men and women between 18 and 75 years of age who served in combat in the Iraq war may be~     eligible for this study. It will compare test results in those who sustained a traumatic~     penetrating or blast-related brain injury during combat with those who did not.~      Participants undergo the following procedures over a 5-day period of testing that lasts about~     6 hours a day:~        -  Medical history and physical examination.~        -  Blood test for genetic analysis.~        -  Electroencephalography (EEG) to measure the electrical activity of the brain.~        -  MRI or CT scans of the brain to look at the structure and blood flow of the brain.~        -  Functional near-infrared spectroscopy (fNIRS) to monitor blood flow in the front part of~          the brain blood by measuring changes in near-infrared light.~        -  Neuropsychological testing, including questionnaires, pen-and-paper or computerized~          tests, and performance of simple actions to measure brain function, language, memory and~          other cognitive abilities..~   "
214343|NCT00754156|"~     For the last 20 to 30 years, damage control laparotomy and decompressive laparotomy have~     emerged as part of the armamentariums for treatment of complex abdominal trauma, abdominal~     compartment syndrome, and critically ill surgical patients with profound acidosis. While~     these advances have saved lives, they have also led to a dramatic increase in patients with~     open abdominal cavities. Various methods have been employed to offer protection to the~     viscera and at the same time, encourage gradual closure of the abdominal fascia. Some of the~     techniques have included the Bogota bag, vacuum pack described by Barker , Wittman patch ,~     and the use of vacuum assisted fascia-closure, including the commercially available system~     offered by KCI. Overall, the abdominal closure rate is approximately 50% to 90% over an~     average of 10 days. Unfortunately, there has been no well-designed comparison study~     available. Some of the best results also require returning to the operating room every 3 to 5~     days.~      At the University of Kentucky Medical Center, a combination of the vacuum pack dressing~     described by Barker, the commercially available VAC system (V.A.C.; KCI International, San~     Antonio, TX) and vicryl mesh closure systems are used. The primary fascial closure rate is~     approximately 50%. It is not standard practice to take patients to the OR every 3-5 days~     routinely.~      Recently, a new FDA listed system (ABRA by Canica) has been introduced using a progressive~     tension system as a novel approach to the management of open abdomen. ABRA provides a dynamic~     reduction of full thickness, severely retracted midline abdominal defects with the goal of~     maintaining or restoring the primary closure option. This subdermal method uses button~     anchors and elastomer to gradually pull the wound margins together. Tension can be set and~     adjusted according to the desired outcome; to stabilize a retracted wound, reduce the wound,~     close the wound or prevent wound dehiscence (Attachment 1: Company brochure). Currently there~     is only one published case report of the success of this device. We hope to be the first~     center to prospectively report a series of patients with open abdomen managed with the new~     ABRA system. In this study, this system will be used in combination with a standard therapy~     used in abdominal wound closure at the University of Kentucky Medical Center. This system is~     called the V.A.C system (V.A.C.; KCI International, San Antonio, Tx). This therapy provides~     active exudate management and containment, assists in reducing abdominal volume and adds~     structural stabilization to adipose tissue.~      Although no highly powered study has been done to establish data on performance, individual~     experiences at several institutions have reached fascial closure rates of higher than 70%~     using the ABRA device. One institution in Las Vegas, Nevada is using the ABRA device in~     combination with the VAC system and has experienced 100% closure rate to date with 12~     patients. The purpose of this study is to collect information about the ABRA system in~     combination with the VAC technique at the University of Kentucky Medical Center. It is our~     belief that using this system will improve the fascial closure rate and thereby produce less~     chance of hernia and reduce long periods of open abdominal wounds. The objective of the study~     is to evaluate a novel approach for closure of open abdomen utilizing the Canica ABRA system~     combined with the K.C.I. VAC System to KCI VAC System alone.~   "
214344|NCT00754143|"~     The purpose of this study is to evaluate the safety and tolerability of two dosing regimens~     of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria~     on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor~     antagonist (ARB) therapy.~   "
214345|NCT00754130|"~     The multiple dose study to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.~   "
214346|NCT00754117|"~     Newly diagnosed DLCL patients will have baselne FDG-PET as part of initial staging (PET-1).~     Patients will then undergo 2 cycles of chemotherapy with R/CHOP. 14 to 21 days following~     cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete~     therapy as planned. Following completion of therapy, standard response assessment will be~     performed, including CT scans of the chest, abdomen and pelvis and FDG-PET scan (PET-3).~   "
214349|NCT00754065|"~     The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho~     Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years~     of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG),~     norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a~     21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or~     headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho~     Tri-Cyclen Lo.~   "
214350|NCT00754052|"~     The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride~     (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome,~     aged 11 to 17.~   "
214351|NCT00754039|"~     The primary objective of this study is to compare the effect of Welchol in combination with~     TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients~     with high cholesterol.~   "
214352|NCT00754026|"~     This study is designed to compare interscalene catheter insertion distances, in order to~     determine which is the best for pain relief after shoulder surgery.~   "
214353|NCT00754013|"~     The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride~     (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome,~     aged 6 to 10 years.~   "
214354|NCT00754000|"~     This study will observe patients who receive external beam radiation for prostate cancer.~     These patients will be localized and tracked (targeted) with the Calypso 4D Localization~     System. These patients will have a uniform treatment plan with reduced PTVs (prostate~     treatment volume) and will be assessed at multiple time points for quality of life and side~     effects related to radiation therapy.~   "
214355|NCT00753987|"~     The objective of the study is to determine whether or not inhalation of hypertonic saline~     will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung~     function.~   "
214356|NCT00753974|"~     Use biospecimens procured from patients and organ donors to improve understanding of~     molecular, cellular, and tissue-level processes produced by cardiovascular disease and~     therapeutic interventions~   "
214357|NCT00753961|"~     This clinical study plans to investigate the effect of the consumption of a fermented dairy~     drink on the occurrence of common infections. This study will be performed in a healthy adult~     population of shift workers.~   "
214358|NCT00753948|"~     Previously it was observed that individuals with tetraplegia have reduced baseline airway~     caliber and exhibit non-specific airway hyperresponsiveness (AHR). In persons with~     tetraplegia we have suggested that this is due to overriding cholinergic airway tone. In~     asthma, the mechanisms underlying bronchoconstriction and AHR are more closely tied to airway~     inflammation. Whether AHR in tetraplegia is also related to chronic airway inflammation is~     unknown.~      Recently, a non-invasive technique for assessing airway inflammation has been established in~     asthma that involves measurement of nitric oxide (NO) concentrations (FeNO) in expired air.~     FeNO is elevated in asthma likely due to excess NO production by inflammatory cells within~     the airway Measurement of FeNO in persons with tetraplegia would help in assessing the role~     of airway inflammation in this population. This may have therapeutic significance in such~     individuals. NO in the lung is felt to be the principal inhibitory neurotransmitter of the~     non-adrenergic, non-cholinergic (NANC) system. It is thought that inhalation of NO has no~     effect on airway tone in healthy individuals but reduces methacholine responsiveness while~     having weak direct bronchodilatory effect in asthmatics.~      The primary purpose of this study is to determine the levels of exhaled NO (FeNO) in~     individuals with chronic cervical spinal cord injury (SCI), and to compare them with those~     obtained in age and sex matched able-bodied individuals and subjects with stable mild to~     moderate asthma. If the FeNO levels are high and comparable to those found in asthmatic~     subjects, this will imply the role of chronic inflammation in reduced baseline airway caliber~     and non-specific airway hyper-responsiveness (AHR) exhibited by individuals with chronic~     cervical SCI. If the FeNO levels are comparable with those found in able-bodied controls,~     this will support our previous statement that unopposed cholinergic innervation is~     responsible for low baseline airway caliber and AHR in individuals with chronic tetraplegia.~     Further scientific conclusions about NO and its role in control of airway tone, pulmonary~     resistances and blood pressure will be drawn upon intravenous and inhaled administration of~     L-NAME. This compound has been shown promising results for the treatment and prevention of~     orthostatic hypotension in individuals with tetraplegia. Knowing its effects on airways and~     potential of easier mode of delivery (inhalation vs. intravenous) is of utmost importance.~   "
214359|NCT00753935|"~     The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a~     molecular level in aspirin-treated patients with coronary artery disease. We hypothesize that~     certain patient characteristics associate with aspirin resistance. In addition, we will~     compare the effects of enteric-coated aspirin and chewable aspirin.~   "
214360|NCT00753922|"~     The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round~     Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary~     augmentation, primary reconstruction, or revision. Safety information on the rate of capsular~     contracture, rupture, and infection will be collected, and used to help determine device~     safety.~      Approximately 1000 patients at centers across the United States will be enrolled in this~     research study. These patients will be implanted with silicone breast prostheses and~     monitored for 10 years to collect information on risks associated with the implant surgery as~     well as changes in the way these patients feel about themselves.~   "
214361|NCT00753909|"~     This trial will evaluate the efficacy and safety of paclitaxel, carboplatin and bevacizumab~     combination, administered biweekly, in patients with pretreated, advanced non small cell lung~     cancer.~   "
214362|NCT00753896|"~     This study will examine the safety of exenatide once weekly (2.0 mg) in approximately 134~     patients receiving treatment with thiazolidinedione alone or thiazolidinedione in combination~     with metformin. Patients are expected to be treated with exenatide once weekly for at least~     52 weeks.~   "
214363|NCT00753883|"~     To compare the lipid lowering efficacy of adding ezetimibe to statin vs. statin alone.~   "
214380|NCT00753649|"~     This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose~     primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity~     in different population of infants residing in Canada.~   "
214392|NCT00753480|"~     This is a Phase I, multicenter, open-label, dose-escalation study of single-agent D4064A~     administered by IV infusion to patients with recurrent or persistent epithelial ovarian~     cancer (EOC), primary peritoneal cancer (PPC), and fallopian tube cancer (FTC) who have~     previously received a platinum-containing regimen. The study will enroll up to 56 patients at~     up to six investigative sites in the United States.~   "
214393|NCT00753467|"~     Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by~     subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or~     Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.~   "
214394|NCT00753454|"~     The purpose of this study is to continue to assess the safety of certolizumab pegol in~     combination with methotrexate (MTX).~   "
214364|NCT00753870|"~     Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of~     different workplaces, and is even found in homes. The endotoxin used for this study is~     obtained from the National Institutes of Health, and is called Clinical Center Reference~     Endotoxin, or CCRE. The purpose of this Phase 1 research study is to identify a dose of~     inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other~     problems), but causes changes in sputum cell samples that the scientists can measure. Phase 1~     research studies like this one are not intended to be a treatment, but are a scientific~     investigation. Eventually, with these types of studies we will be able to examine why some~     people are more sensitive to endotoxin. Scientists at other universities have found that~     while most people do not have a considerable lung response to endotoxin at doses as high as~     60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study~     is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but~     does not cause symptoms in our study subjects. In our previous studies in our lab, using an~     endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma~     with no major problems, and we have used 10,000 EUs of CCRE in subjects who are current~     smokers without seeing any problems.~   "
214365|NCT00753857|"~     RATIONALE:~      The way in which information about a drug is provided may affect the ability of patients and~     doctors to understand how a drug works and the side effects of the drug.~      PURPOSE:~      This randomized trial is studying how well a drug facts page works compared with a short drug~     summary in helping patients and doctors understand medical information.~   "
214366|NCT00753844|"~     The purpose of this study it to evaluate the safety and immune response of peptides (URLC10)~     emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent~     esophageal cancer.~   "
214367|NCT00753831|"~     To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery~     in ptosis~   "
214368|NCT00753818|"~     The purpose of this study is to compare the effects on visual development, growth, cognitive~     development, tolerance, and blood chemistry parameters in term infants fed one of four study~     formulas containing various levels of DHA and ARA.~   "
214369|NCT00753805|"~     The study was performed to investigate the effects of mare's milk on SCORAD, faecal~     microbiota and immunological parameters in patients with atopic dermatitis.~   "
214370|NCT00753792|"~     This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators~     will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate~     or severe attack receiving immunomodulatory therapy or not. Patients will be randomly~     assigned to one of the two groups.~   "
214371|NCT00753779|"~     The primary objective is to determine the effect of WelChol tablets on serum lipids,~     lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized~     on simvastatin therapy for at least 4 weeks.~   "
214372|NCT00753766|"~     The purpose of this study is to advance the quality of care among inpatients with diabetes in~     the VHA. When patients with diabetes are admitted to the hospital, there is a greater chance~     that they will have a complication that lengthens their stay in the hospital. We are testing~     whether managing their diabetes before admission makes a difference in occurrence of~     in-hospital complications.~   "
214373|NCT00753753|"~     The purpose of this study is to determine the effect of clopidogrel or aspirin reactivity as~     measured by a point-of-care platelet function assay on thrombotic or bleeding events after~     percutaneous coronary intervention (PCI) with drug eluting or bare metal stent.~      Methods:~      Platelet reactivity on clopidogrel and aspirin therapy is measured before PCI with VerifyNow~     (Accumetrics Inc.,San Diego, CA, USA) P2Y12 or aspirin assay respectively in 1000 consecutive~     patients from 20 centers in France undergoing coronary angioplasty with stent.~      Exclusion criteria are:~      Acute myocardial infarction, treatment with vitamin K antagonists and the use of antiGP2b3a~     before PCI. All patients are pre-treated with clopidogrel and aspirin. Non-response to~     aspirin or clopidogrel is determined according to the result of the VerifyNow assay (cut off~     : < 15 % for P2Y12 and > 550 ARU for aspirin). The primary end point is the occurrence of~     definite or probable stent thrombosis (ARC definition) and the secondary end-points include~     global and cardio-vascular mortality, non fatal myocardial infarction and major bleeding. A~     clinical evaluation is scheduled at discharge and by telephone contact at one month and one~     year.~   "
214374|NCT00753740|"~     This study will assess the effect of IT-101 on delaying cancer progression in patients with~     platinum sensitive ovarian cancer.~   "
214375|NCT00753727|"~     This research is being done with the aim of developing a more effective treatment than~     standard radiotherapy and surgery alone. Although standard treatment is frequently~     successful, some patients do not respond well to this treatment. Low oxygen levels in~     tumours, which may be a particular problem with sarcomas, are thought to be one factor that~     contributes to failure of radiotherapy. Sunitinib is a new drug that is active against cells~     with low oxygen levels. The combination of sunitinib and radiotherapy has shown promising~     results in other cancers. The purpose of this study is to find out whether treatment with a~     new drug, sunitinib, can increase the effectiveness of radiotherapy at killing cancer cells;~     to test the safety of the combination of sunitinib and radiotherapy.~   "
214376|NCT00753714|"~     The primary objective of this study is to demonstrate an improvement in Progression-Free~     Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine~     plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with~     advanced NSCLC.~   "
214377|NCT00753688|"~     A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft~     tissue sarcoma whose disease has progressed during or following prior therapy~   "
214378|NCT00753675|"~     The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or~     VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free~     survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic)~     biliary tract cancer.~   "
214379|NCT00753662|"~     The primary objective of this trial is to assess the ability of Transcranial Magnetic~     Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive~     performance in patients with Alzheimer's disease which received drug treatment. This study is~     a single-center, double-blind 4 months duration trial.~   "
214381|NCT00753636|"~     The objective of this study is to establish the safety and tolerability of isradipine,~     sustained release preparation in patients with PD. This study is a logical continuation of~     the project that is being completed now and is conducted in preparation to NIH submission of~     the pivotal study on the efficacy of this agent for neuroprotection in PD. This study is~     conducted in parallel with Dr. Surmeier's work on further development of the preclinical~     data. The focus of his work now is to establishing the correlation between the dose that~     demonstrated neuroprotective effect in animal model and the dose used for clinical practice.~      Hypothesis 1: Patients with PD will be able to tolerate isradipine across the FDA recommended~     dose range. We expect 10% attrition due to hypotensive effect of the agent.~      Hypothesis 2: Patients with PD and concomitant stable hypertension will be able to tolerate~     isradipine provided that the dose of the concomitant antihypertensive agent is adjusted based~     on the blood pressure reading.~   "
214382|NCT00753623|"~     This proposal is to conduct a double-blinded, randomized, placebo-controlled, crossover~     clinical study to examine the hypothesis that ramelteon would reduce pain score and improve~     functional status in subjects with neuropathic pain.~   "
214383|NCT00753610|"~     Invasive carcinoma of the uterine cervix remains the most common invasive cancer in women in~     many countries. Concurrent chemoradiotherapy (CCRT) is now recommended as a standard~     treatment for locally advanced and high-risk cervical carcinoma. However, CCRT achieves a~     better control of cervical cancer accompanied by greater morbidity. To avoid unnecessary~     over-treatment, the optimization of CCRT is of critical importance. Herein, the development~     of a surrogate marker for monitoring treatment efficacy as well as toxicity is pivotal to~     optimize CCRT.~      Circulating endothelial progenitor cells (EPC), derived from bone marrow, can be used as a~     marker for optimizing and monitoring the anti-angiogenesis therapy including angiogenesis~     inhibitors and metronomic chemotherapy. Preclinical models indicated that the source of~     apoptotic circulating endothelial cells (CEC) was most likely the tumor vasculature. In~     breast cancer patients, apoptotic CEC were demonstrated to be a surrogate marker for efficacy~     of metronomic therapy.~      In this grant, we intent to monitor the levels of circulating EPC/CEC in locally advanced~     cervical cancer patients before, during and after CCRT.~   "
214384|NCT00753597|"~     This is a pilot study of B lymphocyte depletion therapy in an attempt to salvage adrenal~     steroidogenic capacity in ten subjects with early autoimmune Addison's disease. During the~     first twelve weeks of treatment, additional glucocorticoid therapy (prednisolone) will be~     given to ensure wellbeing and to rest the steroidogenic apparatus that is the target of the~     autoimmune attack. Glucocorticoids will be gradually withdrawn, in a controlled fashion, and~     adrenal function re-evaluated at 13, 26, 39 and 52 weeks. The primary endpoint will be~     restoration of steroidogenic function as judged by conventional endocrine indices of~     adrenocortical function. B cell depletion may ameliorate the autoimmune attack against~     adrenal cells, potentially allowing a state of immune tolerance to be restored with~     subsequent recovery of adrenal steroidogenic capacity.~   "
214385|NCT00753571|"~     This study will examine the effectiveness of Cistanche Total Glycosides(CTG) in treating~     patients with amyotrophic lateral sclerosis (ALS) - a fatal neurological degenerative disease~     that causes adult-onset, progressive motor neurons loss in the spinal cord, brain stem and~     motor cortex. Patients develop progressive wasting and weakness of both upper and lower~     limbs, bulbar and respiratory muscles. Usually death from respiratory failure typically is~     within 3-5 years of diagnosis. Although there are various treatments for ALS, riluzole is the~     only approved treatment to delay the disease progression. Cistanche Total Glycosides is an~     approved drug that has protective effects. It acts anti-apoptosis by activating several~     protective pathways, stimulates neuronal differentiation of adult neural stem cells in the~     brain, and improves long-term recovery. CTG is a highly attractive candidate for the~     treatment of neurodegenerative conditions such as ALS.~      Patients 18 to 65 years of age who have had mild to moderately severe ALS for 0.5 to 2 years~     of duration may be eligible for this study. Candidates will be screened with a medical~     history and possible review of medical records, physical examination, blood test, urine and~     stool analyses, electrocardiogram, electrophysiological examination, neurological imaging~     and, for women, a pregnancy test.~      Participants will have drug therapy according to randomized number. One group receives CTG~     while other group receives placebo. For the procedure, patients are given a medication to~     lessen anxiety and any discomfort. Patients receive drugs for 9 months. The CTG dosage is~     1.8g/day. Physical examination and interview, Appel ALS scale and ALS-Functional Rating Scale~     will be done in 28 days and 3, 6, 9months. Electrophysiological examination will be tested~     per 3 months. Blood samples will be collected on treat28 days and 3, 6, 9months.~   "
214386|NCT00753558|"~     There is an urgent need to control our current national outbreak of carbapenem-resistant~     Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal~     carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and~     polymyxin E administration. This will reduce infections and hopefully mortality caused by~     CRKP.~   "
214387|NCT00753545|"~     The primary purpose of this study to determine if AZD2281 is effective and well tolerated in~     maintaining the improvement in your cancer after previous platinum-based chemotherapy.~   "
214388|NCT00753532|"~     The purpose of the study is to assess the neuroprotective, anti atherogenic and~     hepatoprotective properties of tocotrienols (palm vitamin E) supplementation as determined by~     white matter lesion load on serial magnetic resonance imaging (MRI), carotid artery magnetic~     resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.~   "
214389|NCT00753519|"~     This study will look at the effects of transcranial magnetic stimulation (TMS) on symptoms of~     Parkinson's disease. TMS is a method of brain stimulation that may be able to change the~     activity of the nerve cells of the brain. This study will examine the effects of a specific~     pattern of stimulation called intermittent theta-burst TMS (iTBS), which uses repeated~     magnetic pulses delivered in short bursts.~      People with mild to moderately severe Parkinson's disease who are between 40 and 80 years of~     age and whose main problems are slow movement and stiffness may be eligible for this study.~      Participants undergo the following tests and procedures:~        -  Random assignment to real or placebo (sham) iTBS treatment.~        -  iTBS sessions (real or sham) 4 times a week for 2 consecutive weeks. For this test, the~          subject sits in a comfortable chair. A wire coil is held on the subject's scalp, and a~          brief electrical current is passed through the coil, creating a magnetic pulse that~          stimulates the brain. The subject hears a click and may feel a pulling sensation on the~          skin under the coil. There may be a twitch in the muscles of the face, arm or leg.~        -  Test of gait (walk), hand and arm movements before and after each session. The gait test~          requires walking 10 meters (about 30 yards) in the same corridor with the same shoes.~        -  Extended testing. The first and last gait tests (done before starting iTBS and after the~          eighth session) require coming off any Parkinson's medication for at least 12 hours~          before the test. On these test days, subjects also undergo a clinical examination, short~          neuropsychological test battery, a computer-based reaction time test and depression and~          quality-of-life rating scales. These procedures are repeated in a follow-up visit 1~          month after the last session.~   "
214390|NCT00753506|"~     The investigators intend to explore the hypothesis that symptoms of schizophrenia may be~     reduced by the antimalarial compound artemisinin when used in addition to standard~     antipsychotic medications.~   "
214395|NCT00753441|"~     The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of~     tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and~     gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting~     and surgical bypass are currently the two competing treatment options. There is currently no~     randomized trial comparing the recently developed metal stents to surgical bypass.~     Furthermore, there is very limited data on quality of life of these patients receiving either~     therapy. While endoscopic stenting represents the less invasive treatment, surgery may~     provide better long-term control requiring one-time treatment. Due to the incomplete evidence~     the present randomized controlled trial is designed to compare quality of life of patients~     undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused~     by cancer of the pancreatic head requiring with low bile duct obstruction.~   "
214396|NCT00753428|"~     In this study, the investigators will assess the population effectiveness of using routine~     HAART as a PMTCT strategy, through a community-based survey. The survey will be done in the~     catchment areas of four health clinics in rural Zambia both before and after giving routine~     ART in the clinics, so as to estimate population HIV-free survival among infants born in each~     target community.~      The investigators hypothesize that incorporation of routine ART into PMTCT will increase the~     HIV-free survival of exposed infants to 75%.~   "
214397|NCT00753415|"~     This is a two-part study to test the safety, tolerability, and immune response for V934/V935~     vaccine using a new prime-boost regimen in participants with selected solid tumors.~   "
214398|NCT00753402|"~     Epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland) in~     response to stress such as infection or injury. Endotoxin is a man- made substance, which~     causes the body to mimic sickness (fever, chills, and achiness) for a few hours. This study~     is designed to give epinephrine before and/or after endotoxin to determine if this medication~     can prevent or relieve any of the symptoms caused by endotoxin.~   "
214399|NCT00753389|"~     This Germany-wide, multi-center, epidemiologic study is designed to evaluate the incidence of~     post-operative/anesthesia effects of muscle relaxants (i.e. post-operative residual~     curarization: PORC) and their effect on patient outcome. Aside from biometric data, type of~     operation, use of muscle relaxants and neuromuscular monitoring, all patients will be~     clinically evaluated after their operation in the post-anesthesia care unit. To look at~     long-term effects, patients will be followed-up 28 days after their operation/anesthesia~     regarding post-operative/anesthesia morbidity and mortality.~   "
214400|NCT00753363|"~     Persistent low-grade inflammation and impaired fibrinolysis, are independent predictors of~     several chronic diseases highly prevalent in the older Veteran population including~     cardiovascular disease (CVD), stroke, and diabetes. Inflammation is likely to be a causative~     underlying mechanism of insulin resistance. Lifestyle changes such as weight loss and~     physical activity are advocated for the treatment of these chronic diseases and endpoints,~     and data are emerging which suggest that these treatments may be beneficial, in part, due to~     their anti-inflammatory effects. Identification of effective therapies that reduce chronic~     inflammation for Veterans is important given the widespread adverse health effects of a~     chronically elevated inflammatory state.~   "
214401|NCT00753350|"~     This will be an open label, single-center, feasibility study comprised of two sequential~     cohorts( cohort 1: 2 participants; cohort 2: 8 participants).~      This study will be conducted in generally healthy participants aged 25 to 55 years with~     non-morbid obesity and a pre-screening body mass index between 35 and 40.~      Participants will undergo screening to determine their health status and their eligibility to~     participate in the study. Eligible patients will undergo an endoscopic device delivery~     procedure during which the device will be anchored in the inner stomach wall at the distal~     anterior antrum. Physical examination and/or endoscopic safety evaluations will be conducted~     on day 14 and 28. The device and its anchor will be completely removed endoscopically after 8~     weeks. The participants will be followed-up for safety evaluation for an additional period of~     2 weeks.~   "
214402|NCT00753337|"~     The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt~     Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of~     subjects with Peripheral Artery Disease (PAD).~   "
214403|NCT00753324|"~     The investigators will enroll a cohort of HIV-infected pregnant women accessing PMTCT~     services, to better understand the incremental benefits (e.g. reduction in HIV transmission,~     improvements in HIV-free survival) and risks (e.g. drug toxicities) of the routine HAART~     strategy, in comparison to HIV-infected pregnant women accessing the Zambian Standard of Care~     services.~      The investigators will test the hypothesis that routine use of HAART produces significant~     reductions in HIV transmission rates, with only minimal side effects.~   "
214404|NCT00753311|"~     Triptans are first choice drugs in the acute treatment of migraine and cluster headache.~     However, while in cluster headache the response rate to subcutaneous sumatriptan is 96%,~     around 30% of patients fail to respond to a particular triptan. Nonresponse is likely to be~     due to a variety of factors, including low and inconsistent absorption, inadequate dosing,~     and variability in individual response5. Timing of administration is also a crucial issue. In~     fact, an early treatment of the attack, when the pain is still mild, may increase the~     responders rate by circumventing the development of cutaneous allodynia (expression of~     central sensitization of pain pathway) during the course of the attack.~      Several studies have been performed in an attempt to genetically, psychologically and~     clinically characterize the triptan responders but failed to provide conclusive results.~      Nevertheless, we suggested that the presence of UAs during the migraine attack might predict~     a good response to triptans. UAs are common in migraine patients. They have been reported in~     almost one out of two migraineurs (45.8%) attending a tertiary headache centre and in more~     than one out of four (26.9%) in a population-based study. In an open study with sumatriptan~     50 mg performed on 72 migraine patients with UAs, we described pain relief in 65.3% of the~     patients at 1 h and in 81.9% at 2 h, while pain-free in 30.6% at 1 h and in 61.1% at 2 h. We~     hypothesized a large-scale recruitment of peripheral neurovascular 5-HT1B/1D receptors~     consequent to the activation of the trigeminal-autonomic reflex in such patients. Our~     hypothesis has received further confirmation by the demonstration of higher levels of~     calcitonin gene-related peptide, neurokinin A and vasoactive intestinal peptide (the hallmark~     of the activation of the trigeminal autonomic reflex) in external jugular blood in~     rizatriptan responders than in non-responders.~      The investigators therefore postulate that migraineurs with UAs may respond better to~     rizatriptan than general migraine population.~      The aim of the study is to evaluate the efficacy of rizatriptan 10 mg lyophilized wafer (MLT)~     compared to placebo in the treatment of acute migraine in patients with unilateral autonomic~     symptoms (UAs: unilateral lacrimation, eye redness, eyelid oedema, nasal congestion or~     rhinorrhoea, miosis or ptosis, forehead or facial sweating) during the migraine attack.~   "
214420|NCT00753103|"~     The purpose of this study is to determine whether Infliximab (monoclonal anti-tumour necrosis~     factor alpha antibodies) are safe and effective in the treatment of anti-neutrophil cytoplasm~     antibody (ANCA) associated vasculitis.~   "
214405|NCT00753298|"~     The study is designed as a randomized, double-blind, parallel-group, multi centre study~     comparing perception and tolerability of investigational product and comparator. In the~     randomized part of the study the subjects will be given either LoFric Primo (POBE) or the~     comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception~     and satisfaction of POBE is equal to or better than for PVC.~   "
214406|NCT00753285|"~     The purpose of this study is to investigate the clinical utility of renal denervation for the~     treatment of refractory hypertension.~   "
214407|NCT00753272|"~     The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals'~     influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided~     in two surveillance phases: one passive phase along the study during the influenza season and~     one active surveillance phase during the influenza peak season.~   "
214408|NCT00753259|"~     -  Randomized controlled trial comparing specialized AF Clinic with 'care as usual'~        -  Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF,~          using guideline-based dedicated software, under supervision of a cardiologist, is~          efficient, safe and not inferior to care as usual by a cardiologists.~   "
214409|NCT00753246|"~     Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma~   "
214410|NCT00753233|"~     This study will review medical information collected on children and adolescents with~     hypertrophic cardiomyopathy (HCM) to try to identify risk factors for arrhythmias (abnormal~     heart rhythms) in these patients and better guide the choice of treatment options for them.~     Arrhythmias arising from the ventricle (lower heart chamber) can cause dizziness, fainting or~     cardiac arrest. Predictors of arrhythmias in adult HCM patients may not apply to children and~     teenagers with HCM.~      Children and adolescents 21 years of age or younger who were diagnosed with HCM and evaluated~     in the National Heart Lung and Blood Institute's Cardiology Branch between 1977 and 2002 may~     be eligible for this study.~      Participants do not undergo any further testing or data gathering beyond a review of their~     medical records; only existing data previously collected for research purposes are used.~     Medical records are reviewed for age of the patient on admission to the NIH; family history~     of sudden death, fainting, exercise-induced low blood pressure, and results of tests on heart~     structure and function.~   "
214411|NCT00753220|"~     The purpose of this study is to determine if the intra-tumoral injection of a subject's own~     dendritic cells after cryotherapy of the prostate is a safe and effective treatment for~     advanced prostate cancer.~      In theory, the injected dendritic cells will internalize antigens from the tumor cells which~     have been damaged by cryotherapy and activate the subject's immune system against that~     specific tumor.~      Subjects will also receive a low dose chemotherapy designed to lower the number of~     T-regulatory cells which have been shown to lower or stop some immune system responses.~      Hypothesis 1: Dendritic cell injection into cryotreated prostate cancer is non-toxic;~      Hypothesis 2: Dendritic cell injection into cryotreated prostate cancer is medically~     beneficial to the subject.~   "
214412|NCT00753207|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving lapatinib together with epirubicin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when~     given together with lapatinib in treating patients with metastatic breast cancer.~   "
214413|NCT00753194|"~     The purpose of this study is to investigate the rate of false-positive results in Newborn~     Universal Hearing Screening Programs and it´s possible causes.~   "
214414|NCT00753181|"~     To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal~     Plan including Diabetes-Specific products compared to average daily blood glucose in subjects~     following their usual diet.~   "
214415|NCT00753168|"~     The purpose of this study is to evaluate the safety and potential efficacy of a new drug,~     OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of~     patients with open angle glaucoma or ocular hypertension. It will be compared with commercial~     timolol and placebo eye drops.~   "
214416|NCT00753155|"~     A prospective, interventional rehabilitation program was initiated to improve exercise~     capacity and psychosocial functioning in patients after lung transplantation (LTx) and to~     evaluate long-term effects on health-related quality of life (HRQoL).~      Study subjects were randomized to either intervention or to control group and were followed~     with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months~     after LTx. Patient characteristics did not differ concerning age, gender, and diagnosis at~     study entry. IG patients received regular psychosocial support and performed a home-based~     supervised ergometer training program. CG patients were recommended to perform regular~     exercising.~   "
214417|NCT00753142|"~     Obesity is common in African-American patients with newly diagnosed diabetes who present with~     diabetic ketoacidosis (DKA).1 Despite the presentation with severe symptoms of insulinopenia~     and ketoacidosis, clinical and immunogenetic observations indicate that most obese AA~     patients with DKA have type 2 diabetes. In such patients, our previous studies reveal: a) at~     presentation, obese AA patients with DKA have markedly de-creased pancreatic insulin~     secretion, lower than in obese non-DKA patients admitted with comparable hyperglycemia, but~     significantly greater than in lean patients with DKA;2 b) aggressive diabetic management~     results in significant improvement in b-cell function and insulin sensitivity sufficient to~     allow discontinuation of insulin therapy within 3 months of follow-up.2, 3 Based on these~     observations we conclude that similar to obese patients with hyperglycemia, most obese AA~     with DKA have type 2 diabetes, and that although defects in both insulin secretion and~     insulin action are present, transient b-cell failure is the primary defect in the development~     of ketoacidosis.~   "
214418|NCT00753129|"~     Semi-recumbent position leads to improvement of gas exchange and lung mechanics in patients~     suffering from ALI or ARDS. Prone positioning leads to similar effects. To date, no data on~     the combination of these two positioning measures exist. The investigators hypothesize that~     head elevation in prone position leads to improvement in gas exchange and lung mechanics.~   "
214419|NCT00753116|"~     The purpose of this this study is to investigate the clinical utility of renal denervation in~     the treatment of ESRD patients with refractory hypertension.~   "
214422|NCT00753077|"~     Oral appliances, which can maintain patients' jaw forwards during sleep, become more popular~     in treating obstructive sleep apnea (OSA). However, the exact mechanism of mandible forward~     on upper airway is not completely known. In this study we will use both static and dynamic~     MRI to study the 3D morphological changes and dynamic behavior of the upper respiratory tract~     at different mandible posits. Because in asian society non-obese OSA patients are not~     uncommonly seen, in this study we focus only on non-obese severe OSA patients.~   "
214423|NCT00753064|"~     The data available for the efficacy of AScVS and prazosin is generated through different~     trials done in different clinical setting. Hence it was felt worthwhile to confirm the~     documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a~     clinical trial. Along with this, effects of both the therapies on various biochemical~     parameters will be recorded and compared with. It was also felt necessary to study the effect~     of combination on the clinical outcome.~   "
214424|NCT00753051|"~     Clozapine treatment resistant schizophrenia is still prevalent.The effectiveness of~     augmenting clozapine : one augmenting with haloperidol and the other with electroconvulsive~     therapy should be determined.This study is a randomized control trial.~   "
214425|NCT00753038|"~     The purpose of this Phase 2 study is to investigate whether intravenous administration of~     REOLYSIN® therapeutic reovirus in combination with Paclitaxel and Carboplatin is effective~     and safe in the treatment of squamous cell carcinoma of the head and neck.~   "
214426|NCT00753025|"~     The purpose of this study is to determine whether autologous bone marrow derived cells and~     isolated CD133+ fraction are effective in the treatment limb ischemia~   "
214427|NCT00753012|"~     The purpose of this research study is to learn about the effects of a medication called~     Vyvanse on the heart (cardiovascular system). The U.S. Food and Drug Administration (FDA) has~     approved Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). People~     who have ADHD have trouble paying attention, organizing, and planning; these symptoms can~     cause problems at work, socially and at home.~      Vyvanse (also known as Lisdexamfetamine) is a stimulant class medication. There have been~     reports of serious cardiovascular effects in children and adults treated with stimulants.~     While there is no definite evidence that these events were related to the use of stimulants,~     the deaths have raised questions about the cardiovascular safety of stimulants.~      The study will involve in-depth cardiovascular tests, namely echocardiograph (ultrasound of~     the heart) and cardiopulmonary exercise test (also called stress test; subjects exercise on a~     bicycle while measuring their heart activity and breathing is monitored by cardiologists).~      The investigators predict to see changes in blood pressure and heart rate as shown in~     previous clinical studies, and that the in-depth cardiovascular tests will provide new~     insights into the cardiovascular impact of stimulants.~   "
214428|NCT00752999|"~     Approximately 225 patients meeting study entry requirements will be enrolled and randomized~     (2:1, active versus placebo superimposed on background treatment) to R788 or placebo.~     Patients will be followed for efficacy and safety parameters for 6 months. The investigator~     should taper corticosteroids if clinically warranted.~   "
214429|NCT00752986|"~     The primary objective is to assess the event-free survival defined as the time from~     randomisation to progression, death without progression, loss to follow up, whichever~     occurred first..~   "
214430|NCT00752973|"~     In a previous phase II study, the safety and efficacy of a novel formulation of malathion~     0.5% was evaluated in patients 2 years of age and older. Based on the results of that study,~     this formulation is currently in a phase III study for that population.~      The current study will use blood markers and clinical evaluations to determine the safety and~     tolerability of this formulation when used in children 6-24 months of age.~   "
214431|NCT00752960|"~     The purpose of this study is to assess patients treated with the antipsychotics aripiprazole~     (Abilify®), olanzapine (Zyprexa®), quetiapine (Seroquel®), risperidone (Risperdal®), or~     ziprasidone (Geodon®) and to identify genetic variations more commonly found in individuals~     who develop diabetic metabolic signs and symptoms, which include changes in blood lipids,~     blood glucose, blood pressure, and body weight.~   "
214432|NCT00752947|"~     The purpose of this study is to determine whether moxifloxacin in comparison to levofloxacin~     plus metronidazole are effective and safe in the treatment of community-acquired pneumonia~     with aspiration factors.~   "
214433|NCT00752934|"~     Baclofen is a drug that reduces the muscle stiffness. In disabled children that have very~     stiff muscles, the stiffness and secondary changes in the joints may cause discomfort and~     pain. In this study we will check if treatment with Baclofen reduces pain in disabled~     children with stiff muscles.~   "
214434|NCT00752921|"~     Headache during fasting is a known entity in the scientific literature. The prevalence of~     such a headache is high and in a study conducted in Israel was found in 60% of people with a~     previous predilection for headache. A prior study showed a significant decrease in the~     incidence of fasting headache using rofecoxib, but the drug has been taken off the market.~     The goal of this project is to evaluate the efficacy of etoricoxib as treatment taken before~     the fast- a COX-2 inhibitor with a relatively long half life to prevent fasting induced~     headache. The study will be a prospective double blind placebo controlled trial using adult~     volunteers with a history of a fasting headache who will be abstaining from food and drink on~     Yom Kippur.~      The study hypothesis is that treatment with etoricoxib prior to a 25 hour fast will decrease~     the incidence of fasting headache.~   "
214435|NCT00752908|"~     The purpose of this study is to evaluate cefoxitin pharmacokinetics in obese surgical~     patients.~   "
214436|NCT00752895|"~     RATIONALE: American ginseng extract may prevent or reduce acute respiratory illness in~     patients with chronic lymphocytic leukemia. It is not yet known whether American ginseng~     extract is more effective than a placebo in preventing respiratory infections.~      PURPOSE: This randomized trial is studying the side effects of American ginseng extract and~     to see how well it works compared with a placebo in preventing respiratory infection and in~     reducing antibiotic use in patients with chronic lymphocytic leukemia.~   "
214450|NCT00752713|"~     The aim of the study was therefore to evaluate whether myocardial deformation imaging~     performed by SENC allows for quantification of regional left ventricular function and is~     related to transmurality states of infarcted tissue in patients with acute myocardial~     infarction (AMI).~   "
214437|NCT00752882|"~     Meningitis is an infection where morbidity and mortality depend on the delay of the initial~     treatment for a good prognostic. The antibiotherapy rapidity allows to decrease the~     mortality. Intermittent administration of ceftazidime is a reference treatment of Pseudomonas~     aeruginosa meningitis. In the case of Pseudomonas aeruginosa pneumopathy, ceftazidime can be~     administered by intermittent injections or by continuous perfusion. The continuous~     administration of ceftazidime is not validated in Pseudomonas aeruginosa meningitis. However,~     ceftazidime is a time dependant antibiotic and continuous treatment would provide a more~     efficient therapeutic. The aim of this study is to determine if the continuous administration~     of ceftazidime could permit a better therapeutic practice of Pseudomonas aeruginosa~     meningitis compared with intermittent administrations.~   "
214438|NCT00752869|"~     This is a study using two FDA approved medications: Testosterone and the study medication,~     Dutasteride (Avodart 0.5mg/day). Half of the subjects will receive dutasteride and half will~     receive a placebo. The study medication will be taken for 12 months.~      The subjects participating in the study are men who are already taking their own testosterone~     supplement because they have low testosterone levels which may cause them to experience~     sexual function difficulties, have fatigue or other symptoms. Testosterone can have an~     adverse effect of causing an enlarged prostate (Benign Prostatic Hypertrophy) (BPH).~      Dutasteride (Avodart) is an approved medication used to decrease the prostate size, prevent~     urinary symptoms and reduce the risk of surgery.~      The researchers would like to see if by taking dutasteride and testosterone at the same time~     they can prevent the adverse effects of testosterone and at the same time get the positive~     benefits of testosterone.~      There will be 6 scheduled visits for the study and 2 diagnostic tests called a TRUS~     (TransRectal UltraSound), to evaluate prostate size. The six visits at will include~     consenting, blood work, two sexual function questionnaires, a physical examination, physical~     measurements, study medication teaching and dispensing of study medication.~   "
214439|NCT00752856|"~     CCTG 589 is a randomized, open-label, pilot study comparing the efficacy, safety and~     tolerability of RAL plus LPV/r to EFV plus TDF/FTC in HIV-infected, treatment-naïve subjects.~     Subjects will be ineligible if they have any evidence of drug resistant virus in the past or~     at the time of screening (if never previously tested). Those who are found to be eligible~     will be randomized 1:1 to initiate either LPV/r (400/100 mg) plus RAL (400mg), both given~     twice-daily, or fixed dose combination of EFV (600 mg), TDF (300 mg) and FTC (200 mg) given~     as once-daily Atripla® for 48 weeks.~      Hypotheses~        1. The novel nucleoside-sparing combination of LPV/r + RAL will have a faster phase 1 viral~          decay rate compared to standard-of-care therapy with EFV/TDF/FTC in antiretroviral-naïve~          patients.~             1. Faster phase 1 viral decay dynamics will be associated with improved longer-term~               (week 48) viral suppression.~             2. Faster phase 1 viral decay dynamics will be associated with accelerated early (Day~               0-14) clearance of cell-associated HIV DNA.~             3. Faster phase 1 viral decay dynamics will be associated with greater early (baseline~               to week 12) CD4+ T-cell recovery.~        2. The LPV/r + RAL arm will have greater decreases in early (baseline to week 4) CD4/CD8~          T-cell immune activation and apoptosis which will be associated with greater late (week~          12 to week 48) CD4+ T-cell recovery.~        3. Subjects treated with LPV/r + RAL arm will have smaller changes in total cholesterol and~          triglycerides from baseline than those receiving EFV/TDF/FTC.~   "
214440|NCT00752843|"~     This study is to determine the effect of single and multiple oral doses of mifepristone on~     the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.~   "
214441|NCT00752830|"~     The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328~     in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule)~     during two treatment periods, after food intake or during fasting condition.~   "
214442|NCT00752817|"~     Laparoscopic Colectomy is an advanced minimally invasive procedure that requires advanced~     laparoscopic skills.~      Minimally invasive surgery offers many advantages to the patients but exposes the surgeon to~     new challenges, many of which are human factor in nature. This in turn prolongs the learning~     curve and has delayed the widespread adoption of minimally invasive surgical techniques in~     the management of patients with colorectal disease.~      Virtual reality simulation offers an effective way of training whereby surgical trainees can~     train repeatedly and achieve proficiency in a shorter time and a safe environment.~   "
214443|NCT00752804|"~     Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order~     to optimize the dialysis dose: patients after cardiac surgery.The sampling of blood and~     dialysate will be done during dialyses with different durations (4, 6 and 8h)~   "
214444|NCT00752791|"~     The purpose of this study is to determine the efficacy and safety of peginesatide injection~     for maintenance treatment of anemia in participants on peritoneal dialysis.~   "
214445|NCT00752778|"~     To evaluate the diagnosis value of MRI and positon emission tomography (PET) scan for~     studying macrophagic infiltration and other brain modification in multiple sclerosis (MS)~     patients treated with Natalizumab (Tysabri).~   "
214446|NCT00752765|"~     This project is a prospective observational study that will involve the participation of 25~     volunteers that qualify for having knee osteoarthritis, are going to be having gastric bypass~     surgery and are willing to participate in this study which is designed to last up to two~     years. Potential candidates will be interviewed using a standard set of questions related to~     the study~   "
214447|NCT00752752|"~     Using blood testing and cardiac magnetic resonance imaging (MRI), the investigators aim to~     determine if there are necrotic areas of myocardium in participants who complete a marathon.~     In addition, the investigators aim to describe the acute and chronic structural abnormalities~     that occur as a result of endurance training. The study hypothesis is that myocardial~     necrosis is present in runners completing a marathon competition.~   "
214448|NCT00752739|"~     RATIONALE: Selenium may prevent or slow the growth of prostate cancer.~      PURPOSE: This randomized phase II trial is studying how well selenium works in treating~     patients with prostate cancer.~   "
214449|NCT00752726|"~     The purpose of this study is to determine if a 24 week weight loss program with orlistat 60~     mg will produce greater changes in body composition compared to placebo.~   "
229072|NCT00558571|"~     Primary objective: safety and tolerability of BI 10773 in male and female patients with type~     2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773~   "
214451|NCT00752700|"~     The first part of the study is an observational part. In eligible patients with early stage~     respiratory cancer, the primary and secondary endpoints will be evaluated before and after~     their scheduled radical cancer therapy. The measured variables, include a blood sample,~     pulmonary function tests, level of dyspnea, exercise tests, measurement of body composition,~     respiratory and peripheral muscle force, health related quality of life and psychological~     status. Only registered participants having completed a radical treatment and having either~     less than 70% of the predicted normal value of the quadriceps force (QF) or a decrease of~     more than 10% predicted value of the QF between pre-and post radical treatment, will be~     allowed to participate to the second part of the study. These patients will then be~     randomized in three groups. Group A, the control group, will have the usual care and follow~     up according to clinical symptoms. Group B will be offered a conventional resistance training~     program (CRT), and group C, will be offered a whole body vibration resistance training (WBV)~     on the FITVIBE-platform. All previous variables will be measured after 6 and 12 weeks of~     training.~   "
214452|NCT00752687|"~     To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers~     and its anti-viral activity in HCV infected subjects.~   "
214453|NCT00752674|"~     The research was an interventional study with a quantitative board, fulfilled in a private~     clinique specialized in trauma service; it was formed between august to October of 2006. The~     objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. The~     12 patients, with age between 20 and 55 years, whose did five consultations, with 100%~     presence, got relief of the pain and increase of movement of hips' articulation which was the~     most painful movement with 91,66% graduation. All the patients presented the shorting test~     positive and it kept positive in 7 patients. There was a significant improvement in pain~     relief (p=0,001,) comparing the first and the fifth consultation, and hip articulation~     movement. Even after the relief of the pain, 7(58,3%) of the patients kept the treatment for~     a more effective rehabilitation and prevention of repetition of the symptoms. It was~     concluded that the neuromuscular balance relieved quickly the pain, being essential for~     effective rehabilitation of low back pain, with the inclusion of others manual techniques.~   "
214454|NCT00752661|"~     The purpose of this study is to find the clinical dose range of an active ingredient of~     JNS013 - Tramadol hydrochloride in chronic-pain patients who cannot attain a sufficient~     analgesic effect from non-steroidal anti-inflammatory drugs (NSAIDs).~   "
214455|NCT00752648|"~     The objectives are: to compare the oral bioavailability and plasma pharmacokinetics of~     TMC435350 for 2 different solid formulations to those of TMC435350 formulated as a powder~     blend in a capsule, after a single oral dose of 200 mg in healthy volunteers; to determine~     the short term safety and tolerability of TMC435350 after a single oral dose of 200 mg~     formulated in capsules with 2 different formulations and as a tablet in healthy volunteers~   "
214456|NCT00752635|"~     The purpose of this study was to evaluate the effectiveness and safety of~     norgestimate-ethinyl estradiol as comparted with cyproterone acetate-ethinyl estradiol among~     female patients with moderate acne vulgaris.~   "
214457|NCT00752622|"~     This is an open-label, interventional study where a subset of participants will be randomized~     to one of two treatment-optimization strategies. Participants with moderate to severe Crohn's~     disease (CD) will receive induction treatment comprised of 3 infusions of infliximab at Weeks~     0, 2, and 6. The participants will be evaluated at Week 10. Participants who are in clinical~     response will enter the observational phase of the study where they will receive standard of~     care treatment, as per the infliximab product monograph. Participants who lose response, may~     qualify for entry into the interventional phase of the study, where they will be randomized~     to one of the following treatment-optimization arms: 1) dose increase: infliximab 7 mg/kg,~     every 8 weeks or 2) shortened interval: infliximab 5 mg/kg every 6 weeks.~      Note: Due to early study termination, no statistical analysis was performed for the~     interventional part of this study, therefore, endpoints dedicated to this phase of the study~     have not been analyzed.~   "
214458|NCT00752609|"~     The purpose of this study is to determine the efficacy and safety of Peginesatide Injection~     for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis~     or do not require dialysis and who were previously treated with Darbepoetin Alfa.~   "
214459|NCT00752596|"~     This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl~     in a patient who completed two other protocols (2000098 and 2001060.~   "
214460|NCT00752583|"~     Study in order to quantify toxin removal during dialysis~   "
214461|NCT00752570|"~     This clinical trial will compare the efficacy and safety of the combination of AMG 386 and~     FOLFIRI with FOLFIRI alone in second line treatment of metastatic colorectal cancer.~   "
214462|NCT00752557|"~     The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM~     injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures~     of the hip. All subjects will receive standard treatment for low bone mass, consisting of~     bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly~     selected to receive treatment with rhBMP-2 will receive an injection directly into the hip.~     The injection is given in a surgery room using a light anesthesia.~   "
214463|NCT00752544|"~     The purpose of this study is to evaluate the safety and tolerability of three different doses~     of TMC435350 compared to placebo in healthy Japanese males.~   "
214464|NCT00752531|"~     All chronic obstructive pulmonary diseases (COPDs) block air flow to the lungs, and the two~     most common forms, emphysema and chronic bronchitis, are the most common causes of~     respiratory failure. Previous research shows that if COPD patients know more about their~     disease and how to manage it themselves, they will improve their quality of life and reduce~     their need for urgent care. However, traditional methods of teaching COPD patients about~     their disease and self-management skills are expensive and require intensive work. A new,~     less expensive way of reaching a large group of people with this information is needed to~     help patients stay healthier and happier with their treatment. This study will create a~     computer program that can help people learn about their disease and how to manage it~     themselves. This study will then determine whether the computer program, called Home~     Automated Telemanagement (HAT), helps patients with COPD in managing their disease and~     following their treatment plans.~   "
242488|NCT00380471|"~     The purpose of this study is to determine whether bath PUVA are effective in treatment of~     vitiligo and what is the complication of bath PUVA in vitiligo.~   "
214465|NCT00752518|"~     The purpose of this study is to assess the safety/tolerability and determine the Japanese~     recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice~     weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days~     12 to 21) in Japanese patients with relapsed or refractory multiple myeloma.~   "
214466|NCT00752505|"~     The study is designed to assess if esreboxetine can improve the cognitive function of~     patients with fibromyalgia. Cognitive function is defined as the ability to concentrate,~     remember things and make decisions or problem solve. The study is also designed to assess if~     there is a difference in cognitive function between fibromyalgia patients and matched control~     subjects.~   "
214467|NCT00752492|"~     Faster recovery from anesthesia is important for obese patients because they are at high risk~     of respiratory complications following tracheal extubation. Isoflurane has several properties~     that make it a preferable agent for anesthesia in obese patients. Its main limitation is a~     longer recovery time due to slower elimination in comparison to other agents. Elimination of~     isoflurane from the lungs can be accelerated by increasing in patient's minute ventilation,~     which decreases the level of CO2 in blood (hypocapnia).Isocapnic Hyperpnoea (IH) is a method~     allowing increased ventilation and therefore enhancement of the elimination of inhalation~     agents while maintaining a normal blood CO2 level. The investigators will compare recovery~     time from isoflurane anesthesia in obese patients during standard anesthesia management~     protocol (control) to a group treated with IH.~   "
214468|NCT00752479|"~     This a pilot, explorative study to define the safety and biological/mechanistic effect of the~     systemic intravenous infusion of syngeneic ex-vivo expanded MSCs in living-related kidney~     transplant recipients (one or two HLA haplotype mismatches) under basiliximab/low-dose RATG~     induction therapy and maintenance immunosuppressive drugs with the ultimate objective to test~     the feasibility of safely achieving graft tolerance in a subsequent efficacy pilot study.~      Specific objectives To compare changes in the immunophenotype and ex-vivo T-cell functional~     tests from samples of peripheral blood and measurement in the urine of messenger RNA for~     FoxP3,in kidney transplant recipients given or not syngeneic (from the recipient) MSC~     infusion under basiliximab/low-dose RATG induction therapy and maintenance immunosuppressive~     treatment with low-dose cyclosporine (CsA) plus low-dose mycophenolate mofetil (MMF).~      This will assess at different time up to 12 months post transplant. In addition the safety~     profile of MSC infusion will be investigated. We have planned to start with the safety and~     biological/mechanistic study in 6 living-related kidney transplant recipients. Three patients~     will receive ex-vivo expanded syngeneic MSC infusion (2x106 MSCs per kilogram body weight) at~     the time of kidney transplant, and 3 additional patients no cells (controls), both under the~     cover of induction therapy with basiliximab and low-dose RATG, and maintenance~     immunosuppression with low-dose CsA and MMF. Randomization to MSC or no cell infusion will be~     performed at the time the recipient will sign the informed consent to participate to the~     study.~      Should this biological/mechanistic ex vivo studies document that MSC infusion allows the~     development of an immune microenvironment permissive to graft tolerance, a pilot efficacy~     study to achieve operational tolerance after complete withdrawal of maintenance~     immunosuppressive therapy will follow.~      In this additional pilot explorative efficacy study all consecutive patients will be included~     and followed until the first episode of rejection (if any) will occur or 29 consecutive~     patients have successfully withdrawn the immunosuppressive therapy. This has been estimated~     according to the Simon's two-stage minimax design.~   "
214469|NCT00752466|"~     The primary purpose of this open-label study is to determine if concomitant therapy with~     topiramate and flunarizine has any effect on the pharmacokinetics of either drug. Safety will~     be assessed for all subjects, for the entire duration of the study.~   "
214470|NCT00752453|"~     Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order~     to optimize the dialysis dose: patients with lactate acidosis. The sampling of blood and~     dialysate will be done during dialysis with different durations (4, 6 and 8 h)~   "
214471|NCT00752440|"~     This study describes a controlled randomized clinical trial to evaluate the effect of~     inspiratory muscle training in patients with diabetic autonomic neuropathy.~   "
214472|NCT00752427|"~     The purpose of this open-label study was to evaluate the safety and tolerability of flexible~     doses of Extended Release OROS® Paliperidone in the treatment of geriatric subjects with~     schizophrenia after completion of the initial double blind study~   "
214473|NCT00752414|"~     Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent~     acute exacerbations (AECB) which are associated with enormous healthcare expenditures and~     significant morbidity, specifically an increased risk of death, a decline in pulmonary~     function and a significant change in quality of life. Bacteria appear to have an important~     role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in~     COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In~     addition, recent studies indicate that acquisition of a new strain of H. influenzae, M.~     catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations.~     Chronic inflammation and bacterial infection predispose many patients to frequent and~     recurrent acute exacerbations.~      Mpex, (the sponsor on record at time of the study's initial registration) believes that~     intermittent administration of inhaled MP-376 in high risk patients will decrease the~     incidence of acute exacerbations by both by lowering the organism burden, and resultant~     inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.~   "
214474|NCT00752401|"~     The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3)~     substitution on the posttransplant outcome (glomerular filtration rate as well as serum~     creatinine levels, number of acute rejection episodes, number of infections and C-reactive~     protein levels within the first year after transplantation) in vitamin D deficient kidney~     transplant recipients.~   "
214475|NCT00752388|"~     To assess the predictive value of sequential administration of WHO-5 and MDI (Major~     Depression Inventory) for the clinical management of Parkinson Disease (PD) patients by~        -  determination of the prevalence of depression in PD patients, based on MDI severity~          categories and the self-rating scale WHO-5, where poor well being was indicated.~        -  exploration of influencing factors (PD status, therapeutic status) on the prevalence of~          MDI depression categories.~   "
214476|NCT00752375|"~     Children who present with pyelonephritis undergo many investigations, and long term care to~     prevent renal damage. The focus is primarily on preventing renal failure however along the~     way and particularly with children, other issues arise which impact their lives, as well as~     their family's lives. Parents are concerned about subjecting their children to invasive~     procedures and long term antibiotic use, particularly if they are not sure of the benefit.~     This study seeks to provide information on the impact of investigation and long term~     antibiotic treatment in reference to long term health and quality of life in children who~     present with febrile urinary tract infections in the absence of anatomic abnormalities.~   "
214700|NCT00749398|"~     This is a national, multi-center, observational, prospective photographic atlas study in~     subjects who are treated with infliximab for moderate-to-severe psoriasis in daily clinic~     according to local country regulations and reimbursement.~   "
214477|NCT00752362|"~     Objectives:~      PRIMARY OBJECTIVE:~      To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents~     with the late loss of bare metal control stents.~      SECONDARY OBJECTIVES:~      Safety:~      To compare the occurrence of Major Adverse Cardiac Events (MACE) at 30 days, 9 months, 1~     year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.~      To compare the occurrence de Serious Adverse Events (SAEs) within 5 years among the~     paclitaxel, sirolimus and control study arms.~      To compare the occurrence of in-stent thrombosis within 5 years among the paclitaxel,~     sirolimus and control study arms.~      Efficacy:~      To compare the rate of angiographic success among the study groups To compare the rate of~     procedural success among the study groups To compare the incidence of clinically driven~     target lesion revascularization at 9 months, 1 year, 3 years and 5 years among the~     paclitaxel, sirolimus and control study arms.~      To compare the incidence of clinically driven target vessel revascularization at 9 months, 1~     year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.~      To compare the 1-year, 3-year and 5-year cost-effectiveness profile of the paclitaxel,~     sirolimus and control study arms.~      To compare the 9-month in-stent late loss of paclitaxel-eluting stents to the in-stent late~     loss of sirolimus-eluting stents To compare the 9-month in-segment late loss among the study~     groups To compare the 9-month in-stent and in-segment binary restenosis rate among the study~     groups To compare the IVUS percent neointimal obstruction among the study groups~      Study Design:~      In the present RANDOMIZED study, the paclitaxel-eluting stent Infinnium® and the~     sirolimus-eluting stent Supralimus® will be compared to a metallic stent with the same~     structure (Milennium Matrix®) but without drug elution for the treatment of de novo lesions~     in native coronaries. The study will be a multicenter clinical trial and will include~     patients for the treatment with one of the three study stents. In total, 275 patients will be~     enrolled, randomly allocated for the Infinnium®, Supralimus®, or Milennium Matrix® stents in~     a 2:2:1 proportion. Patients will be followed-up for 12 months after the index procedure. All~     patients will undergo a follow-up angiography at 9 months. A subgroup of 55 patients will be~     evaluated at 9 months with IVUS examination.~      Treatment:~      Patients will be treated, according to the randomization groups, with Infinnium®,~     Supralimus®, or Milennium Matrix® stents of 19 mm, 23 mm, or 29 mm and nominal diameters of~     2.5, 3.0, and 3.5 mm.~   "
214478|NCT00752349|"~     Ultrasound is widely applied in many fields of medicine but less commonly used in the~     evaluation of tongue movement and swallowing abnormality. Fuhrman RAW reported the usefulness~     of using ultrasound to evaluate poor tongue coordination [1]. Peng CL stated that ultrasound~     could provide excellent quantitative and qualitative bases of tongue movement during~     swallowing using cushion-scan technique [2]. Videofluoroscopic swallowing study (VFSS) is~     widely accepted as the gold standard of evaluating swallowing abnormality because it is able~     to evaluate the whole swallowing procedure without interference of pharyngeal contraction and~     foreign body sensation when swallowing is examined by using a fiber-optic laryngoscope. One~     of the most important information that VFSS can provide is the detection of subclinical~     silent aspiration. The decision and management of many patients with swallowing abnormalities~     are usually based on the VFSS findings [3]. As shown in many reports, our experiences showed~     that VFSS provided extremely important information of understanding the pathophysiologic~     change of dysphagia due to variable etiologies, such as in patients with nasopharyngeal~     cancer suffering from radiation therapy [4] and in patients with stroke [5]. Using the~     findings of VFSS, physicians and medical staffs can make important decision whether oral~     feeding should be given, which safety swallowing maneuver works and what is the appropriate~     choices of food consistency safe to dysphagic patients. The difficulties of VFSS are usually~     in the transportation of paraplegic and hemiplegic patients from ward to the examining chair.~     The frequency and examination duration of VFSS is usually limited for avoiding unnecessary~     radiation exposure. Hence, ultrasound provides a role in evaluating oral condition with the~     benefits of convenience of transportation and availability as well as no radiation exposure.~     Therefore, validation of the value of ultrasound for the oral swallowing with correlation of~     VFSS is important to test the clinical feasibility.~      Peng CL et al reported their experiences of using real-time ultrasound in the evaluation of~     intrinsic tongue movement [2, 6, 7]. The findings of submental ultrasound are quite different~     from the findings of VFSS which provides the surface information of the tongue in the~     swallowing of radiopaque barium sulfate bolus. Combined real-time B mode and M mode~     ultrasound, it was reported the potential of digital data analysis of oral phase swallowing.~     Kuhl V et al reported the usefulness of ultrasound in the evaluation of laryngeal elevation~     in patients with dysphagia [8]. They found significant decrease of laryngeal elevation in~     patients diagnosed as neurogenic dysphasia [8]. Casas et al successfully combined ultrasound~     examination and plethysmography to evaluate the swallowing condition of children with~     cerebral palsy [9]. The results of these studies explained the potential of ultrasound in~     oral swallowing and dynamic laryngeal movement.~      Our experiences of VFSS showed the usefulness VFSS in diagnosing and management of patients~     with swallowing problem or dysphagia [4, 5, 10, 11]. To our knowledge, there was little~     experience of comparing between ultrasound and VFSS in patients with swallowing problem.~     Therefore, we conducted this study to correlate submental ultrasound and VFSS findings and~     tried to find out the clinical feasibility and usefulness.~      Purposes: This study was to evaluate the usefulness of submental ultrasound (SM US) in oral~     phase swallowing in correlation with videofluoroscopic study (VFSS).~        1. To compare normal volunteers and patients with swallowing abnormality with submental~          ultrasound.~        2. To evaluate and compare patients with swallowing problem using submental ultrasound and~          VFSS.~      Type of study: Retrospective. Time of study: Jan 2004 - July 2006.~   "
214479|NCT00752336|"~     A prospective, interventional rehabilitation program was initiated to improve exercise~     tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to~     evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were~     randomized to either intervention or to control group and were followed with regular~     cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after HTx.~     Patient characteristics did not differ concerning age, gender, and diagnosis at study entry.~     IG patients received regular psychosocial support and performed a home-based supervised~     ergometer training program. CG patients were recommended to perform regular exercising.~   "
214480|NCT00752323|"~     RATIONALE: Imaging procedures that use aminolevulinic acid may help find and diagnose~     residual tumor in patients with grade IV malignant astrocytoma who are undergoing surgery to~     remove the tumor.~      PURPOSE: Our primary long-term goal is to improve the completeness of surgical resection of~     malignant brain tumor through image- guided fluorescence localization. We hypothesize that~     the use of qualitative fluorescence imaging and point PpIX concentration quantification will~     enable more complete tumor resection than normal direct (i.e., white light) visualization,~     and thereby improve patient survival.~   "
214481|NCT00752310|"~     The purpose of this study is to evaluate in healthy volunteers how much and how fast the new~     suspension compared to the commercial darunavir tablet, given in combination with low-dose~     ritonavir, are absorbed into the body (called the relative oral bioavailability).~   "
214482|NCT00752297|"~     The overall purpose of this study is to evaluate the safety and effectiveness of an~     intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with~     placebo.~   "
214483|NCT00752284|"~     The purpose of this study is to compare the surgical complications and neurosensory~     disturbance of coronectomy and conventional excision of wisdom teeth with roots in close~     proximity to inferior alveolar nerve. Hypothesis: Coronectomy of wisdom tooth can reduce the~     chance of injury to the inferior alveolar nerve in cases of radiographic proximity to the~     roots when compared with conventional method of surgical removal of wisdom teeth, and there~     is no difference in other surgical morbidities.~   "
214484|NCT00752271|"~     The purpose of this study is to examine the relationship between muscle activation and heart~     rate on joint generalized inflammation and arthritis development.~   "
214485|NCT00752258|"~     The overall purpose of this study is to evaluate the long-term safety of repeat treatment~     with an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines.~   "
214486|NCT00752245|"~     Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order~     to optimize the dialysis dose: patients with sepsis/multi-organ failure. The sampling of~     blood and dialysate will be done during dialyses with different durations (4, 6 and 8h)~   "
214487|NCT00752232|"~     The study is to evaluate the safety, tolerability and whether there is an immune system~     response to multiple doses of ACC-001 with or without the use of a substance that may~     increase the response to the drug.~   "
214488|NCT00752219|"~     The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the~     treatment of complicated intra-abdominal infections as compared to a comparator group.~   "
214489|NCT00752206|"~     The purpose of this study is to determine how long patients who undergo complete surgical~     removal of recurrent osteosarcoma in the lung will remain free of cancer after taking~     Saracatinib compared to patients taking placebo (a sugar pill).~   "
214490|NCT00752193|"~     The purpose of this study is to assess the safety and the efficacy of vaginally administered~     probiotic lactobacilli in combination with antibiotic therapy (metronidazole) in women with~     microbiologically defined bacterial vaginosis.~   "
214491|NCT00752180|"~     The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard~     to its total and to its maximum serum insulin concentrations.~   "
214492|NCT00752167|"~     We hypothesize that exercise-induced bronchospasm (EIB) at the NCAA Division I collegiate~     level is over diagnosed, while poorly controlled asthma resulting in exercise-related~     symptoms in this same population may be under diagnosed, being erroneously attributed to EIB.~     This project will test individuals self-identified as having exercise induced bronchospasm or~     asthma, as well as gender-matched controls from the same sport, with eucapnic voluntary~     hyperventilation to assess for the presence of EIB or asthma. By making the correct~     diagnosis, improved health outcomes may be achieved and athletic performance may be enhanced.~   "
214519|NCT00751816|"~     RATIONALE: Early physical therapy may be effective in improving range of motion of the neck~     and shoulders in head and neck cancer survivors who are undergoing chemotherapy and radiation~     therapy.~      PURPOSE: This phase I trial is studying how well early physical therapy works in improving~     physical and functional well-being in head and neck cancer survivors receiving~     chemoradiotherapy.~   "
214520|NCT00751803|"~     The objective of this trial is to assess the safety, tolerability, and efficacy of three~     doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache~     pain of moderate or severe intensity, compared to placebo and an active comparator.~   "
214521|NCT00751790|"~     Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate~     cancer. It was assumed that during the study treatment >90% of the patients would achieve and~     maintain castrate levels of serum testosterone.~   "
214493|NCT00752154|"~     Curcuma longa or turmeric is a tropical plant native to south and southeast tropical Asia.~     Perhaps the most active component in turmeric is curcumin which may make up 2-5% of the total~     spice in turmeric. The study drug being tested in this study is curcumin.~      This study is called a cross-over study because all subjects will receive the study drug for~     a certain amount of time and then switch to placebo (an inactive substance) for a certain~     time or vice versa. The subject's participation may last up to 8 months.~      The subject will be randomized (by chance; like flipping a coin) to receive either the study~     drug, curcumin, or placebo for 4 months. After 4 months, if the subject was taking curcumin~     they will stop taking it and begin to take placebo and if the subject was taking placebo they~     will stop taking it and begin taking curcumin for the remaining 4 months. By completion of~     the study, all 40 subjects will have taken curcumin and placebo for 4 months each.~      Curcumin/placebo will be provided in capsule form and the subject will take it by mouth. The~     dose dose will be increased every week for up to a total of 4 grams per day.~      Subjects will have blood tests, complete questionnaires, and be seen by the study doctor.~   "
214494|NCT00752141|"~     The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets~     and oxybutynin gel.~   "
214495|NCT00752128|"~     The primary objective of the RESOLUTE international registry is to document the safety and~     overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a~     'real-world' patient population requiring stent implantation.~   "
214496|NCT00752115|"~     A comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with~     carboplatin and weekly taxol in patients with previously untreated advanced non-small cell~     lung cancer. The study hypothesis is that sildenafil may improve the distribution and~     efficacy of cytotoxic anticancer agents.~   "
214497|NCT00752102|"~     Patients with chronic kidney disease (CKD) have a higher mortality rate than the general~     population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths.~     Vascular calcification is a common finding in patients with CKD. Furthermore, patients with~     CKD develop secondary hyperparathyroidism, partly because of a decrease of calcitriol~     synthesis on the kidney. Treatment of secondary hyperparathyroidism includes use of activated~     vitamin D including calcitriol and paricalcitol. Recent evidence in dialysis patients suggest~     an improved survival in patients using paricalcitol compared to calcitriol.~      Studies in uremic rats suggests that there are differential effects of calcitriol and~     paricalcitol in expression of markers of soft-tissue calcification independent of~     calcium-phosphorus product. Calcitriol increased calcification of vascular smooth muscle~     cells cultured in calcification media. There was also significant increase in pulse pressure~     in animals treated with calcitriol.~      The investigators hypothesize that these different forms of vitamin D may have differential~     effects in vascular calcification progression in CKD patients.~   "
214498|NCT00752089|"~     The purpose of this study is to determine whether an experimental fluoridated dentifrice is~     effective in the treatment of dental caries~   "
214499|NCT00752076|"~     1. Detection EGFR mutation of cancer cells from malignant pleural effusion. 2. Established~     the cancer cell lines with without EGFR mutation from malignant pleural effusion.~   "
214500|NCT00752063|"~     HCC is an aggressive, largely chemo-resistant cancer with a poor prognosis, currently there~     is no effective systemic chemotherapy for HCC. Epidermal growth factor receptor (EGFR) and~     vascular endothelial growth factor (VEGF) are both overexpressed in HCC and thought to~     contribute to tumor development. Oxaliplatin in combination with other chemotherapies or~     biologic agents have been shown to be an effective and safe treatment in advanced HCC~     patients.~      Sorafenib, an oral multi-kinase inhibitor, blocks tumor cell proliferation by targeting~     multiple growth factor pathways and also exerts an anti-angiogenic effect. Clinically, single~     agent Sorafenib has been shown to have some efficacy in patients with advanced HCC and the~     primary result of prolonged overall survival seems to have been achieved in the phase III~     trial.~   "
214501|NCT00752050|"~     The overall purpose of this study is to evaluate the safety and effectiveness of repeat~     treatment of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines,~     compared with placebo.~   "
214502|NCT00752037|"~     A single center, open label, 48-week study of lopinavir/ritonavir in combination with~     raltegravir. 30 patients, both naïve and experienced, will be enrolled. 15 treatment naïve~     patients and 15 treatment experienced patients enrolled~   "
214503|NCT00752024|"~     The purpose of this study is to evaluate the superiority of effect of the modified~     micro-invasive aspiration and drainage and conservative medical therapy in the treatment of~     ICH spontaneously hypertensive scientifically.~   "
214504|NCT00752011|"~     The goal of this clinical research study is to find the highest safe dose of the combination~     of TAS-106 and carboplatin that can be given to patients with advanced cancer or cancer that~     has spread.~      Objectives:~      Primary Objectives:~      To determine the maximum tolerated dose (MTD) of the combination of TAS-106 and carboplatin~     administered by intravenous infusion every 3 weeks.~      To perform Pharmacokinetic (PK) analysis of TAS-106 and carboplatin~      Secondary objectives:~      To assess the antitumor activity of TAS-106 combined with carboplatin~      To investigate the relationship between selected biomarkers and efficacy and safety outcomes.~   "
214505|NCT00751998|"~     A prospective, multi-center registry for subjects undergoing Endoscopic retrograde~     Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary~     disease.~   "
214506|NCT00751985|"~     The purpose of the study is to determine whether a web-based ultra-brief intervention,~     consisting of personalized normative feedback or standardized self-help material, is~     effective in lowering self reported alcohol use in heavy drinkers.~   "
214522|NCT00751777|"~     To evaluate and compare the immune responses and safety following a two vaccination regimen~     by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or~     placebo patches.~   "
214523|NCT00751764|"~     The purpose of this study is to evaluate the extent of moxidectin transfer into the breast~     milk of lactating women and to provide the initial pharmacokinetic and safety profile of~     moxidectin in lactating women.~   "
214701|NCT00749385|"~     A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments,~     each containing one or both components.~   "
242906|NCT00374959|"~     The primary purpose of the trial is to compare the efficacy and safety of two measures which~     claim to prevent early-onset ventilator-associated pneumonia.~   "
214507|NCT00751972|"~     The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD~     System in patients listed for cardiac transplantation with refractory, advanced heart failure~     at risk of death. The primary endpoint is survival at 180 days which is defined as alive on~     the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. Patient~     must survive 60 days post-explant for recovery to be considered successful. Secondary~     endpoints include:~        -  Overall survival~        -  Incidence of all serious adverse events, neurocognitive status and unanticipated adverse~          device effects.~        -  Incidence of all device failures and device malfunctions~        -  Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire~          (KCCQ) and EuroQoL EQ-5D~        -  Functional status improvement, as measured by the New York Heart Association (NYHA) and~          6-minute walk~      The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to~     cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be~     followed to an outcome at six months, and then patients will receive continued follow-up in a~     separate study.~   "
214508|NCT00751959|"~     This study investigates the efficacy of surfactant application during spontaneous breathing~     with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a~     gestational age of less than 27 weeks.~   "
214509|NCT00751946|"~     This study will compare treatment outcomes of 90 adolescent girls who are (a) at high risk~     for delinquency and/or are juvenile justice involved, and (b) who are experiencing symptoms~     of PTSD: 45 of the girls will receive Trauma Affect Regulation: Guide for Education and~     Therapy (TARGET, Frisman, Ford, Lin, Mallon, & Chang, in press), and their outcomes will be~     compared to 45 girls who receive Enhanced Treatment as Usual (ETAU). As part of their~     involvement, participants will make phone calls to provide data via an interactive voice~     response system (IVR), meet 3 times for a research interview, and be invited to participate~     in a cognitive assessment substudy at the Olin Neuropsychiatric Research Center at Hartford~     Hospital.~   "
214510|NCT00751933|"~     Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between~     natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We~     hypothesise that an improvement or even normalisation of this balance may be achieved by the~     use of vaccines and dietary oats. The combined use of oral typhoid vaccine and~     cholera/ETEC-vaccine is supposed to stimulate mucosal defence factors, while dietary oats~     modifies the microbial environment inside the intestinal lumen. Or study aim is to show if~     such treatment brings symptom relief to patients with ulcerative colitis.~   "
214511|NCT00751920|"~     The purpose of this study is to apply the techniques of dynamic MRI imaging enhancement to~     research participants with one or more pulmonary nodule to determine if meaningful~     information about the nature of the nodule can be obtained. This data will then be compared~     with follow up information about nodule growth or histology obtained by biopsy or surgical~     resection.~   "
214512|NCT00751907|"~     The purpose of this study is to evaluate the hypothesis that in middle-aged, asymptomatic,~     adult children of persons with Alzheimer's disease (AD), atorvastatin therapy will~     beneficially affect mechanisms thought to contribute to AD risk by improving blood flow in~     the brain, improving cerebral perfusion, increasing brain activity patterns, and improving~     blood vessel function.~   "
214513|NCT00751894|"~     Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy~     provides an efficient stem cell mobilization in children with malignancies Design: phase 2~     study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a~     standard apheresis (less than 3 blood volume processed~   "
214514|NCT00751881|"~     The primary objective of the study was to assess the effect of two doses of teriflunomide, in~     comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants~     with relapsing MS.~      Key secondary objective was to assess the effect of the two doses of teriflunomide, in~     comparison to placebo, on disability progression.~      Other secondary objectives were:~        -  To assess the effect of the two doses of teriflunomide in comparison to placebo on:~             -  Fatigue;~             -  Health-related quality of life, a measure of the impact of the participant's health~               on his or her overall well being.~        -  To evaluate the safety and tolerability of teriflunomide.~   "
214515|NCT00751868|"~     The purpose of this study is to assess the feasibility of Ixabepilone (4 cycles) administered~     every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil,~     Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of~     G-CSF.~      To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the~     axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due~     to toxicity of the regimen.~   "
214516|NCT00751855|"~     This study seeks to examine the efficacy of hydrocortisone administration in the augmentation~     of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested~     treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD).~     The augmentation builds on both the translation of neuroscience findings demonstrating the~     effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other~     investigators demonstrating beneficial effects of GCs in reducing traumatic memories in~     trauma-exposed persons.~   "
214517|NCT00751842|"~     The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in~     alum) is effective in preserving the body's own insulin producing capacity in patients~     recently diagnosed with type 1 diabetes.~      Based on results from other clinical trials with the study drug it was judged unlikely this~     study would meet the intended primary or secondary efficacy endpoints. Therefore the primary~     focus of this study was changed to ensure that safety data was available for at least 6~     months following the last dose of active study drug. Thereafter the study was terminated.~   "
214518|NCT00751829|"~     To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan~     medoxomil compared to nitrendipine in elderly and very elderly patients with isolated~     systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil~     compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of~     treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week~     treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure.~     Efficacy and safety measurements are carried out at up to 15 visits during the trial period.~   "
214524|NCT00751751|"~     To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to~     losartan in elderly and very elderly patients with essential hypertension. The study~     hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean~     sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study~     duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment~     hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements~     are carried out at up to 18 visits during the trial.~   "
214525|NCT00751738|"~     This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day~     of azimilide in patients who completed protocol 2000098.~   "
214526|NCT00751712|"~     One known risk of pediatric heart surgery is the possibility for brain damage. This problem~     results from a lack of oxygen rich blood flow to the brain during surgery. In order to~     provide the patient's brain with blood during this operation, selective cerebral perfusion is~     sometimes used. This technique allows for adequate blood flow to the brain, and is monitored~     using special sticker sensors. The sensors are applied to the patient's forehead, and a~     corresponding monitor indicates oxygen levels in the front part of the brain. The goal of~     this study is to find out if these same stickers can be applied to the base of the skull to~     measure cerebral oxygenation at the back of the brain, and to determine if the back of the~     brain is adequately oxygenated during selective cerebral perfusion in patients undergoing~     complex aortic arch reconstruction.~   "
214527|NCT00751699|"~     This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3~     regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x~     400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area~     under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total~     5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.~   "
214528|NCT00751686|"~     The purpose of this study is to measure the disease burden from RV GE among children less~     than 5 years of age using hospital surveillance data. In addition, data collected will~     determine the seasonal distribution, disease severity, age distribution of RV GE. From an~     economic standpoint, the cost and impact of RV will also be assessed.~   "
214529|NCT00751673|"~     This observational study intends to collect efficacy and safety data on TESS shoulder system~   "
214530|NCT00751660|"~     RATIONALE: Screening may help doctors find lung cancer sooner, when it may be easier to~     treat.~      PURPOSE: This clinical trial is studying screening methods to see how well they find lung~     cancer early in current or former smokers.~   "
214531|NCT00751647|"~     The purpose of this project is to determine the short-term effects of a customized Core~     Strengthening and Respiratory Exercise Program (CSREP) on children with cystic fibrosis (CF)~     between the ages of 10 and 21 who are receiving outpatient care at Children's Hospitals and~     Clinics of Minnesota. The CSREP, which will be provided by a physical therapist and a~     physical therapist assistant, consists of specific breathing techniques and core~     strengthening exercises, designed to improve rib cage mobility, pulmonary function, aerobic~     capacity, posture, and core strength. Currently the CF population at Children's receives~     physical therapy on an inpatient basis only.~      The overall goal of this program is to prove the viability of an outpatient exercise program~     for this population. Specific aims include:~        -  To customize a CSREP protocol per each patient~        -  To measure patient outcomes at baseline and six months~        -  To develop a satisfaction tool in order to measure patient experience and satisfaction~   "
214532|NCT00751634|"~     There are few treatments for central fever (fever that is due to the central nervous system,~     as opposed to an infectious source). We hypothesize that an externally applied cooling~     blanket will reduce temperature in neurologically ill patients with central fever.~   "
214533|NCT00751621|"~     This study is a continuation of the study ZLB06_001CR with the objective of assessing~     efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life~     in patients with PID.~   "
214534|NCT00751608|"~     This study will evaluate the effect of APL180 on endothelial function measured by forearm~     venous occlusion plethysmography in patients with familial hypercholesterolemia.~   "
214535|NCT00751595|"~     The study is a randomized, open label, phase II clinical trial directed at evaluating the~     immunogenicity (as a primary end-point) and the safety (as a secondary end-point), of the~     recombinant HIV-1 Tat vaccine in HIV-1 infected adult subjects, anti-Tat antibody negative,~     HAART-treated with chronic suppressed HIV-1 infection, CD4+ T cell counts >= 200~     cells/microliter, levels of plasma viremia < 50 copies/ml in the last 6 months prior to the~     screening and without a history of virologic rebound. The immunogenicity of 3 or 5~     immunizations of the two different vaccine doses (7.5 and 30 micrograms) of the Tat vaccine~     has been evaluated.~   "
214536|NCT00751582|"~     Supplementary feeding and intensive IEC at the community level will effectively reduce~     moderate PEM compared to the control children within 3 months .~      Intensive nutrition education at the household level will reduce by at least one third of the~     prevalence of moderate malnutrition (40% of present level) within a short period of 3 months~   "
214537|NCT00751569|"~     Umbilical cords contain immature blood cells, including a group of lymphocytes, that are~     important in the so-called natural immunity. We want to study the cytokine levels in~     umbilical cord NK cells and its regulation a family of newly identified small RNAs~     (microRNAs).~   "
214538|NCT00751556|"~     To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660~     mg relative to the established commercial Aleve 220 mg tablet following single dose~     administration and at steady-state following multiple dose administration for 4 days.~   "
214548|NCT00751426|"~     Psychiatric disorders or drug addiction are often regarded as contraindications against the~     use of Interferon-alpha in patients with chronic hepatitis C. The investigators aim is/was to~     get prospective data about adherence, efficacy and mental side effects of IFN-alpha treatment~     in different psychiatric risk groups compared to controls. In a prospective trial, 81~     patients with chronic hepatitis C (positive HCV-RNA and elevated ALT) and psychiatric~     disorders (n=16), methadone substitution (n=21), former drug addiction (n=21) or controls~     without psychiatric history or addiction (n=23) should be/were treated with a combination of~     IFN-alpha-2a 3 x 3 Mio U/week and ribavirin (1000-1200 mg/day).~   "
242907|NCT00374946|"~     Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic~     survival data.~   "
214539|NCT00751543|"~     Lung cancer is one of the leading causes of cancer-related death in Taiwan. Recently, there~     are more treatment methods available which result in increased patient survival. Although~     adenocarcinoma and squamous cell carcinoma were both categorized as non-small cell lung~     cancer (NSCLC), the recent advancement of target therapy implied that these two histologies~     behave differently (Shah NT, et al. 2005; Sandler A, et al. 2006). Radiation therapy is an~     important method for locally advanced non-resectable non-small cell lung cancer (NSCLC).~     Computed tomography (CT) is the mainstay for evaluating lung cancer. The advance of multi-row~     detector CT (MDCT) provides volumetric acquisition within a breath hold, and enables detailed~     evaluation of tissue and organ perfusion with excellent resolution. Using this new technique~     with image post processing, excellent spatial resolution and functional perfusion information~     can be obtained simultaneously. Therefore, the purpose of this study is to explore not only~     the longitudinal change of lung cancer eligible for radiation therapy (including concurrent,~     sequential chemoradiotherapy and high-dose radiation therapy) but also comparison of~     adenocarcinoma and squamous cell lung cancers using perfusion MDCT. Total twenty patients~     with histopathologically proved adenocarcinoma or squamous cell carcinoma will be enrolled in~     this study and receive longitudinal study for perfusion MDCT evaluation before, during~     radiation therapy and in early and late phases after complete radiation therapy. Dynamic~     perfusion will be used for processing the image data, and quantitative parameters such as~     tumor blood volume and permeability etc will be derived. From this study, we expect to~     understand the change of tumor vascularity after radiation therapy and characters of~     treatment response of adenocarcinoma and squamous cell carcinoma in addition to the change of~     tumor size.~   "
214540|NCT00751530|"~     This is a retrospective chart review of participants in raltegravir expanded access program~     and will compare virologic response in regimens not containing a protease inhibitor in the~     antiretroviral background regimen to regimens containing a protease inhibitor in the~     background regimen.~   "
214541|NCT00751517|"~     The Systemic Necrotizing Vasculitides (SNV) encompass a group of rare diseases which include~     Wegener's Granulomatosis (WG), Churg-Strauss Syndrome (CSS), Microscopic polyangiitis~     (MPA)and Polyarteritis nodosa (PAN). Common histological findings are inflammation with~     fibrinoid necrosis of the small vessels and sporadic or absent immune-deposits. The gold~     standard therapy for SNV is currently represented by the association of Cyclophosphamide and~     Prednisone. The limits of this approach are the high frequency of recurrent disease and an~     increased incidence of malignancy and infections. The aim of the present study is to compare~     the efficacy of Methotrexate vs Cyclophosphamide for Remission Maintenance in SNV.~   "
214542|NCT00751504|"~     Atypical antipsychotics have been found not only to be beneficial in the treatment of~     psychotic disorders, but even for depressive symptoms in patients with schizophrenia.~     Remarkably, preliminary data suggest that the atypical antipsychotic quetiapine has~     antidepressive properties. Until now, there is limited knowledge concerning the efficacy of~     quetiapine in major depressive illness and especially in psychotic depression. In our own~     clinical practice, several patients with psychotic depression were successfully treated with~     quetiapine as add-on therapy or as monotherapy. On the background of that, the convincing~     effects of quetiapine in bipolar depression, single-case reports and pilot studies concerning~     its effectiveness in depressive mood states in psychotic disorders as well as our clinical~     experiences, it is to assume that a treatment with quetiapine over a 6 weeks period show~     similar effects in major depressive episode with psychotic features, i.e. psychotic~     depression. In this pilot study we plan to investigate 20 patients with psychotic features of~     depression under treatment with quetiapine.~   "
214543|NCT00751491|"~     Percutaneous coronary intervention (PCI) is associated with up to 30% incidence of~     myonecrosis, as reflected by elevation of cardiac enzymes in a successful procedure. Apart~     from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of~     myonecrosis after PCI might be distal embolization of atherogenic materials from plaque~     disruption causing obstruction of blood ﬂow at capillary level resulting in micro-infarction.~     Recent studies have suggested that pretreatment with adenosine in the cath lab and~     Clopidogrel and statins greater than 6 hours before may be associated with a reduction in~     infarct size after reperfusion therapy for acute myocardial infarction. Whether pretreatment~     with adenosine decreases the incidence of myonecrosis in patients undergoing non-urgent PCI~     is not fully known. The investigators propose that adenosine-induced hyperaemia can~     potentially ameliorate the deleterious effects of distal embolization associated with~     non-urgent PCI through dilatation of the microvasculature. Mechanistically, this may reduce~     capillary obstruction by facilitating the throughput passage of embolized platelet thrombi~     out to the venous end of the coronary circulation, thereby reducing the incidence of post-PCI~     myonecrosis. In this prospective, randomized, open-label study, the investigators evaluated~     the incidence of myonecrosis after non-urgent PCI with a treatment with intracoronary~     adenosine compared with pretreatment of loading dose of Clopidogrel 300/600 mg >/< 6 hours.~   "
214544|NCT00751478|"~     The purpose of the study is to determine the relative pharmacodynamic effects and safety of~     crushed and whole ALO-01 compared to MSIR and to Placebo, and of crushed ALO-01 to whole~     ALO-01; to determine the relative bioavailability of plasma morphine from crushed and whole~     ALO-01 compared to MSIR, and from crushed ALO-01 to whole ALO-01; and to determine the~     relative bioavailability of plasma naltrexone and 6-β-naltrexol from crushed ALO-01 to whole~     ALO-01.~   "
214545|NCT00751465|"~     Blushing is associated with a heightened self-focused attention. In our study we are~     interested if this self-focused attention can be shown experimentally and if it can be~     changed by therapy and training. For the experimental part of the study, we want to compare~     blushing fearful individuals to social anxious participants who are not fearful of blushing~     and to healthy controls who report to blush either seldom or quite often. In the~     therapeutical part of our study, we compare an attention training to the standard cognitive~     behavioral therapy for social anxiety disorder in an intensive group therapy approach.~   "
214546|NCT00751452|"~     determine the interest of the dosage of citrullinemia to monitor the bowel damage after~     allogeneic bone marrow transplantation in children.~   "
214547|NCT00751439|"~     The purpose of this his post-market, observational study titled Verification of Pulse~     Oximetry in the Neonatal Population is to gather data to further support the accuracy of~     Nonin's pulse oximeters when used in the neonate population. Neonates who are currently~     undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited~     to participate in this study for collecting opportunity samples. Nonin's PureLight®~     noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the~     sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate~     measurements which are sent to the oximeter module for display on the Electronic Data~     Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a~     marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of~     pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of~     SaO2 (opportunity samples) determined by a CO-oximeter.~   "
214552|NCT00751374|"~     Catheter-related infection, namely exit site infection and peritonitis, is the commonest~     complication of peritoneal dialysis. This complication causes significant morbidity and~     mortality in patients requiring peritoneal dialysis. Topical application of mupirocin 2%~     cream was first proven to be effective in reduction of staphylococcus-related catheter~     infection in 1990s. Subsequent randomized trial published in 2005 showed that gentamicin~     cream was superior to mupirocin 2% cream in reducing both Gram's positive and Gram's negative~     related catheter infection. However, a retrospective report published in 2007 puts the use of~     prophylactic antibiotic cream into a question. It reported an emergency of non-tuberculous~     mycobacterial infection in a dialysis center in Hong Kong after practising prophylactic~     application of gentamicin cream at the catheter exit site. The following prospective,~     randomized and open-label study aims to find out an optimal regimen of topical antibiotic~     prophylaxis in patients requiring peritoneal dialysis.~   "
214553|NCT00751361|"~     Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry~     age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of~     therapeutic apheresis using the methodology of double filtration plasmapheresis to treat~     microcirculatory disorders.~   "
214554|NCT00751348|"~     This Phase 3b study is being conducted for the purpose of registration of the GSK208136~     vaccine in Korea.~   "
214555|NCT00751335|"~     That ThermoSMart humidification will result in greater compliance (mask on time, objective~     and subjective sleep quality than conventional humidification.~   "
214556|NCT00751322|"~     Specific aim: To test whether transfusion of leukoreduced red cells of lesser storage time~     (versus conventional storage time) reduces mild alterations in pulmonary function and immune~     activation in critically ill patients with mechanically ventilated lungs.~      We propose to perform a prospective, randomized, double-blind clinical trial in critically~     ill patients whose lungs are mechanically ventilated, and who have orders to receive~     transfusion of at least one unit of packed red cells, comparing pulmonary function between~     patients randomly allocated to receive a unit of red cells stored for 5 days or less, with~     similar patients randomly allocated to receive a unit of red cells stored conventionally~     (median 21 days). We will test the hypothesis that transfusion of red cells of lesser storage~     age, (5 days or less) will produce the less changes of pulmonary function and immune~     activation than will transfusion of red cells of conventional storage age (median 21 days).~   "
214557|NCT00751309|"~     The objective of the LARGO Study protocol is to collect peripheral blood samples, select~     associated lung biopsy pathology slides, and clinical data from lung transplant recipients to~     perform molecular analyses in association with the study endpoints. The primary objective is~     to use gene expression profiling of peripheral blood mononuclear cells to differentiate~     between the absence and presence of acute cellular rejection. The secondary objectives are to~     use other genomic and proteomic technologies to analyze RNA and protein in blood samples in~     relation to related clinical conditions. The overall goal is to apply novel molecular~     insights in the development of non-invasive molecular diagnostic tests for lung~     transplantation.~   "
214558|NCT00751296|"~     This study will assess the~        -  efficacy (response rate) of oral lenalidomide in the treatment of patients with~          symptomatic, previously untreated, chronic lymphocytic leukemia (CLL),~        -  toxicity of lenalidomide in patients with CLL as well as time to progression, stable~          disease duration and, if responses are observed, response duration.~   "
214559|NCT00751283|"~     The purpose of this study is to evaluate the safety and efficacy of the Minnow Medical GRST~     Peripheral Catheter System in the treatment of new lesions in the superficial femoral artery~     or the popliteal artery.~   "
214560|NCT00751270|"~     This phase I study evaluated a Gene Mediated Cytotoxic Immunotherapy approach for malignant~     gliomas, including glioblastoma multiforme and anaplastic astrocytoma. The purpose of this~     study was to assess the safety and feasibility of delivering an experimental approach called~     GliAtak which uses AdV-tk, an adenoviral vector containing the Herpes Simplex thymidine~     kinase gene, plus an oral anti-herpetic prodrug, valacyclovir, in combination with standard~     of care radiation.~   "
214561|NCT00751257|"~     N-acetylcysteine is an inexpensive agent with a benign side effect profile with preliminary~     studies in humans suggesting efficacy for the treatment of cocaine dependence.~     N-acetylcysteine has been used in clinical medicine for nearly three decades to treat chronic~     lung conditions, acetaminophen overdose, and experimentally to treat cocaine dependence. It~     is generally safe and well tolerated. The present pilot study seeks to explore safety and~     tolerability, ad lib smoking, visual cue reactivity, and smoking reduction rates in a group~     of nontreatment seeking, nicotine dependence smokers who are willing to undergo a brief trial~     with oral N-acetylcysteine 1200 mg twice daily.~   "
214562|NCT00751244|"~     The study is a randomized trial of two manualized 12-session one-to-one educational and~     therapeutic interventions for post-traumatic stress disorder (PTSD), to test and compare~     their efficacy for reducing PTSD symptoms as a means of prevention of intergenerational~     victimization by or involvement in criminal activities with at-risk mothers. The two~     therapies are (1) Trauma Affect Regulation: Guide for Education and Therapy (TARGET) and (2)~     Present Centered Therapy (PCT). The study also included a wait-list comparison condition in~     which participants were offered one of the two therapies following completion of baseline and~     posttest assessments.~   "
214563|NCT00751231|"~     This is a multi-center, randomized, double-blind, triple-dummy, clopidogrel-controlled study~     of IV and oral PRT060128 compared to clopidogrel in patients undergoing non-urgent (including~     elective) PCI. After diagnostic angiography, patients scheduled for non-urgent PCI will be~     randomized to clopidogrel or to one of three dose levels of PRT060128.~   "
214564|NCT00751218|"~     This was a randomized, double-blind, parallel-group, multicenter study that used both an~     active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily~     during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1~     ratio.~   "
214588|NCT00750906|"~     This study will be conducted to determine the pharmacodynamics, cardiovascular and~     biochemical effects of succinylcholine when given during electroconvulsive therapy. (ECT).~     This is a single center, prospective, study in patients who will be receiving ECT as~     indicated and prescribed by their psychiatrist. The study will be performed twice on each~     patient, 48-72 hours apart during consecutively scheduled ECT procedures.~   "
214565|NCT00751205|"~     This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the~     safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced~     peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours~     on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient~     is benefitting. In addition patients will receive ALC or placebo, starting 1 week before~     first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone.~     Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be~     determined by the incidence of all grades of peripheral neuropathy with the results of a~     patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined~     by the tumor response.~   "
214566|NCT00751192|"~     Men who have sex with men (MSM) account for the greatest burden of the HIV and Sexually~     Transmitted Infection (STI) epidemic in Peru. Current interventions that promote early~     identification and treatment of these diseases target a limited number of this population~     because they rely solely on peer education. To assess the use of the Internet as an~     alternative tool to reach this population the investigators propose to conduct an online~     randomized controlled trial to compare the effect of HIV-testing motivational videos versus~     standard public health text, both offered through gay websites. The methodology the~     investigators will use is divided in: (1) the development period, where the investigators~     will select gay websites for banner advertisement, create and refine effective recruitment~     messages and design the online survey and the video-based intervention (2) the intervention~     period, where participants who meet the eligibility criteria will be randomized into a video~     or a standard public health text. The videos will be customized for three audiences based on~     self-identification: gay, non-gay and trans and will be framed within the health-belief model~     and the stages of change theory (3) in the outcome evaluation period we will compare the~     'intentions to get tested' and 'time to HIV testing at the clinic' among MSM of each of the~     trial arms. If the Internet is an effective venue to reach MSM for HIV testing, Peruvian~     health programs that target this population may start considering the delivery of web-based~     interventions and other online prevention services to this under served and hard-to-reach~     population.~   "
214567|NCT00751179|"~     A multi-center, randomized, parallel group, comparative, active controlled, safety assessor~     blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine~     alone in subjects undergoing short surgical procedures in out-patient surgicenters. The~     primary objective was to evaluate changes in plasma potassium levels after treatment with~     rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical~     procedures in out-patient surgicenters.~   "
214568|NCT00751166|"~     This was a randomized, double-blind, parallel-group, multicenter study that used both an~     active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily~     during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1~     ratio.~   "
214569|NCT00751153|"~     Subjects with HIV who have viral suppression on current regimen but also have side~     effects/intolerance will change their current regimen to a combination of Raltegravir and~     Atazanavir and be monitored for viral and immunological response and quality of life.~   "
214570|NCT00751140|"~     The primary objective is to show that performing a lymph node dissection may detect occult~     nodal metastasis in this patient population whereby providing important diagnostic~     information, with potential therapeutic benefits in patients with isolated nodal metastases.~      In case of urothelial carcinoma of the upper urinary tract (a cancer originating from the~     inner lining of the urinary tract) requiring the removal of the kidney, ureter, and cuff of~     bladder (a surgical termed a nephroureterectomy). Previous studies in urothelial carcinoma of~     the bladder, have shown that doing a lymph node dissection (surgically removing the lymph~     nodes) may improve survival, or at least give an idea of what patients may need chemotherapy~     (drugs to control the cancer cells that are outside the kidney-ureter) earlier (before the~     nodes are enlarged in the imaging studies).~   "
214571|NCT00751127|"~     PhXA41 is not inferior to timolol~   "
214572|NCT00751114|"~     The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin~     in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment~     period.~      Secondary objective was to assess the effect of insulin glargine in comparison with~     sitagliptin on:~        -  HbA1c level~        -  Fasting Plasma Glucose (FPG)~        -  7-point plasma glucose (PG) profiles~        -  Percentage of patients with HbA1c <7% and <6.5%~      Safety objectives consisted of:~        -  Hypoglycemia occurrence~        -  Body weight~        -  Overall safety~   "
214573|NCT00751101|"~     RATIONALE: Nicotine patches may reduce hand-foot syndrome in patients receiving capecitabine~     for metastatic breast cancer. It is not yet known which nicotine patch regimen may be more~     effective in reducing hand-foot syndrome.~      PURPOSE: This randomized clinical trial is studying which schedule of using nicotine patches~     is more effective in reducing hand-foot syndrome in patients who are receiving capecitabine~     for metastatic breast cancer.~   "
214574|NCT00751088|"~     The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To~     date, there is an increasing use in the clinical practice of new techniques for the treatment~     of this condition and several surgical devices, characterized by minimally invasive approach,~     are commercialized.~      Recently, single-incision devices have been proposed. One of the most relevant potential~     advantages of these devices is the possibility of performing their positioning under local~     anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly~     useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress~     incontinence not associated to pelvic organ prolapse (POP) and women whose stress~     incontinence raised after surgical correction of (severe) POP.~      Poor data coming from randomized controlled trials (RCTs) are available regarding~     single-incision devices for the treatment of stress incontinence, and there are no~     conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no~     randomized controlled trial is actually available in literature comparing different~     single-incision devices.~   "
214589|NCT00750893|"~     This protocol posting deals with objectives and outcome measures of the primary phase at one~     month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use~     of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves~     male or female infants from the age of 6 weeks at the time of the first vaccination. The~     vaccination course must be completed by the age of 24 weeks.~   "
214575|NCT00751075|"~     This study was conducted to compare the effectiveness and safety of mometasone nasal spray~     once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms~     of acute rhinosinusitis. Patients received mometasone nasal spray 2 sprays per nostril once~     daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo~     three times a day. Patients on nasal spray were treated for 15 days and patients on~     amoxicillin or placebo were treated for 10 days. All patients were followed-up with a 14-day~     no-treatment observation period.~   "
214576|NCT00751062|"~     PhXA41 is not inferior to timolol in reducing intra-ocular pressure~   "
214577|NCT00751049|"~     Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure~   "
214578|NCT00751036|"~     The study will investigate the comparative efficacy and safety of two oral inhibitors of Kit~     and PDGFR: nilotinib 400 mg bid, a novel agent, and imatinib 400 mg bid, an approved agent~     with an established efficacy.~   "
214579|NCT00751023|"~     Methamphetamine dependence is a serious public health problem with no pharmacologic~     treatments currently available. Relapse rates are high in this population. Exposure to cues~     previously associated with methamphetamine use may induce profound craving in abstinent~     individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits~     that may undermine successful participation in psychosocial treatments. Medications which~     improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence~     rates, especially in the critical early period of recovery. Modafinil is an atypical~     stimulant medication with evidence to support its use in treating cocaine dependence and~     attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate~     modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.~   "
214580|NCT00751010|"~     The etiology of pain in women with IC is often difficult to identify resulting in unnecessary~     medical and surgical treatments (e.g. hysterectomies). The vulva may actually be the site of~     some of the reported pain in women with IC, not the urethra or bladder. IC and vulvodynia can~     impact one's sexual functioning and diminish one's quality of life. Unfortunately, vulvodynia~     is often unrecognized since it is not part of the usual urological assessment with IC~     patients.~      Vulvodynia is characterized by persistent generalized or localized vulvar pain of varying~     degrees often characterized as burning, suggestive of a neuropathic pain response.~   "
214581|NCT00750997|"~     This project seeks to determine the effect of prehospital resuscitation with hypertonic~     saline vs. conventional crystalloids on the inflammatory response after injury. The leading~     cause of late mortality following injury is multiple organ dysfunction syndrome (MODS), which~     results from a dysfunctional inflammatory response after injury. Previous studies suggest~     that hypertonic saline may be beneficial by modulating this initial response and decreasing~     subsequent organ injury. This project takes advantage of a unique opportunity, afforded by an~     NIH-funded multi-center clinical trial of hypertonic resuscitation (conducted by the~     Resuscitation Outcomes Consortium), to obtain blood samples from patients enrolled in this~     trial to analyze inflammatory responses early after hypertonic vs. conventional~     resuscitation. This study was an ancillary study to the main randomized clinical trial and~     thus prospective observational in nature~      The proposed study will be carried out in experiments grouped in three Specific Aims: Aim 1~     provides a thorough investigation of the immunomodulatory response following hypertonic~     resuscitation with regard to neutrophil, monocyte, and T cell responses at serial time points~     after injury and resuscitation. Aim 2 comprises experiments to investigate the mechanisms by~     which hypertonicity may alter inflammatory cell signaling. Aim 3 seeks to correlate the~     laboratory findings with clinical endpoints reflective of immune dysfunction including~     inflammation, organ failure, nosocomial infection, and sepsis.~      The investigators hypothesize that hypertonic resuscitation will be associated with~     modulation of the excessive inflammatory response seen after injury and thus will result in~     reduced rates of inflammatory organ injury.~   "
214582|NCT00750984|"~     This study compares the posterior approach to the anterolateral approach using the ReCap®~     Total Hip Resurfacing System.~   "
214583|NCT00750971|"~     While glucocorticoids and immunosuppressants ameliorate manifestations of SLE in many~     patients, current therapies are insufficient to control the disease in a subset of patients,~     and their clinical prognosis remains poor due to the development of vital organ failure,~     cumulative drug toxicity and to the increased risk of cardiovascular disease and malignancy.~     Immunoablative chemotherapy followed by autologous hematopoietic stem cell transplantation~     (ASCT) has recently emerged as a promising experimental therapy for severely affected~     patients, providing them the potential to achieve treatment-free, long-term remission. The~     investigators postulate that immunoablative therapy eliminates or effectively reduces the~     level of autoreactive T and B lymphocytes and then regeneration of de novo immunity resets~     the autoreactive immune system into a self-tolerant, protective immune system resulting in~     prolonged and treatment-free remission.~   "
214584|NCT00750958|"~     The purpose of this study is to determine the incidence of clinically significant rhythm and~     rate changes in ED patients who are not placed on conventional telemetry, and to test the~     user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy~     emergency room.~   "
214585|NCT00750945|"~     Sensory and motor cueing have been demonstrated as useful ambulation training techniques for~     Parkinson's disease (PD). This study is aimed to evaluate the effectiveness of treadmill~     training program with music cueing for mild to moderate PD patients.~   "
214586|NCT00750932|"~     The purpose of the proposed project is to characterize the neutrophile proteases which~     participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and~     which are responsible for the degradation of the lung tissue.~      The respiratory failure which results from it is one of main causes of the fatal evolution of~     this pathology but the anti-inflammatory therapies based on the use of antiproteases~     targeting specifically the soluble elastase did not end, until now, in the hoped results.~      The identification of the other noxious targets is a crucial element to give new orientations~     to the anti-inflammatory strategies based on the administration of antiproteases which remain~     a promising way.~   "
214587|NCT00750919|"~     This trial is a 26-week, open label extension trial to investigate safety and explore~     efficacy of esmertazapine in participants with insomnia who completed protocol~     21106/P05701/MK-8265-002 (NCT00631657).~   "
214590|NCT00750880|"~     This open-label, single arm study will investigate the safety, tolerability and efficacy of~     tocilizumab monotherapy, or combination therapy with non-biologic disease modifying~     antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive~     tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The~     anticipated time on study treatment is 3-12 months, and the target sample size is >500~     individuals.~   "
214591|NCT00750867|"~     Multiple System Atrophy (MSA) is a progressive sporadic neurodegenerative disorder leading to~     widespread loss of brain cells that results in parkinsonian, cerebellar and autonomic~     dysfunction. The cause of the MSA remains unclear. Available treatment is symptomatic only~     and does not alter the course of disease.~      Although the cause of MSA remains unclear, there is evidence of presence of common~     neuroinflammatory mechanisms in the MSA brains including activation of microglia and~     production of toxic cytokines. This research protocol is based on hypothesis that the MSA~     progression can be altered by blocking the neuroinflammatory activity.~      This protocol includes administration of intravenous immunoglobulin (IVIg). IVIg contains~     antibodies derived from human plasma which can block the inflammatory responses in the brain~     that can lead to loss of brain cells.~   "
214592|NCT00750854|"~     The purpose of this study was to evaluate the use of the dietary supplement Natural Eggshell~     Membrane (NEM) for the treatment of joint and connective tissue discomfort & pain.~   "
214593|NCT00750841|"~     Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body~     handles the experimental drug cediranib in patients with advanced cancer.~   "
214594|NCT00750828|"~     The investigators questioned whether patients with dry mouth complaints display any reduction~     in residual saliva coating the gingiva and other selected mucosal surfaces. We further~     intended to test the hypothesis that Gingival Crevicular Fluid volume in patients with dry~     mouth could be different from that of control subjects. Correlations between gingival/mucosal~     wetness; and unstimulated whole salivary flow rate or minor salivary gland secretion rates~     and the correlations between clinical periodontal status and salivary measures were also~     attempted.~   "
214595|NCT00750815|"~     Cyclophosphamide is a chemotherapy agent with known activity in myeloma. The new regimen that~     we will test in this study is called CVDD and contains Cyclophosphamide with Bortezomib~     (VELCADE), Pegylated Liposomal Doxorubicin (DOXIL®, PLD), and Dexamethasone (VDD).~      The purpose of this study is to determine if the addition of another type of chemotherapy~     agent, Cyclophosphamide, to the regimen VDD (CVDD) is well tolerated and improves response~     rates in myeloma. We will also find the highest safe dose of the study drugs taken together~     that a patient can tolerate, and how long it takes for multiple myeloma patients to respond~     after they have taken the study drugs and how long the response lasts.~   "
214596|NCT00750802|"~     The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on~     sleepiness, concentration and brain activity.~   "
214597|NCT00750789|"~     It has been proven in in-vitro studies that dates decrease the oxidative stress in serum.~     There have been no in-vivo studies to this date. The current study aims to test whether dates~     consumption by healthy adults decreases serum oxidative stress and improves serum PON1~     activity and serum lipid profile.~   "
214598|NCT00750776|"~     Rating and registration in KMS database of all patients in anti-psychotic treatment with 8~     selected items from PANSS, GAF, 21 selected items from UKU, 3 selected items from TSQM. and~     measurement of compliance. Frequency of use of rating scales per participating health care~     professional.~   "
214599|NCT00750763|"~     Colonoscopy is the gold standard investigation for assessing the lining of the colon. Colon~     cleansing preparations are required to be taken prior to colonoscopy to provide effective~     visualisation and identification of any abnormalities and different types of colon cleansing~     preparations exist.~      Some colon cleansing preparations have been shown to cause visible changes in the lining of~     the bowel which may cause confusion and incorrect diagnoses to be made.~      This audit aims to assess the ability of different colon cleansing preparations to clear the~     colon of faeces. The tolerability of each will also be assessed, as will any changes in the~     lining of the bowel to assess if one type of colon preparation is more likely to cause~     visible changes than another.~   "
214600|NCT00750750|"~     This study was conducted to compare the effectiveness and safety of mometasone nasal spray~     once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms~     of acute rhinosinusitis. Patients received mometasone nasal spray 2 sprays per nostril once~     daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo~     three times a day. Patients on nasal spray were treated for 15 days and patients on~     amoxicillin or placebo were treated for 10 days. All patients were followed-up with a 14-day~     no-treatment observation period.~   "
214601|NCT00750737|"~     The objective of this study is to compare the safety and efficacy of ABLC versus oral~     Posaconazole in the prevention of invasive fungal infections in high risk patients with~     hematologic malignancies or hematopoietic stem cell transplant.~      Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal~     infections associated with ABLC or Posaconazole prophylaxis.~      Secondary objective will be to compare the cost effectiveness of these two prophylactic~     regimens.~   "
214602|NCT00750724|"~     OA knee is a common degenerative diseases of the joint.~        -  There are many methods to treat this condition.~        -  Hyaluronic acid is one of the recomended treatment of OA knee.~        -  There is no any study on MRI change after injection hyaluronic acid.~        -  The Hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in~          patient with osteoarthritis of the knee compared to placebo .~   "
214603|NCT00750711|"~     The purpose of this study is to compare the efficacy of 4 mm irrigated catheters with 2 mm~     irrigated catheters for ablation of typical flutter.It's a prospective randomised multicenter~     study.~   "
214604|NCT00750698|"~     Preclinical studies have shown that SNDX-275 is able to reactivate the expression of EGFR,~     E-cadherin and ErbB3 expression. The combination of SNDX-275 with erlotinib (an EGFRi) in~     patients who are progressing on erlotinib will show measurable activity as evidenced by the~     disease control rate and with an acceptable safety profile.~   "
214636|NCT00750230|"~     The purpose of this study was to evaluate the use of the dietary supplement Natural Eggshell~     Membrane (NEM) for the treatment of joint and connective tissue discomfort, pain, and~     flexibility.~   "
214605|NCT00750685|"~     The purpose of this study is to determine the safety and effectiveness of the Becker~     Expander/Breast Implant in women who are undergoing primary breast reconstruction. Safety~     information on the rate of complications, such as infection will be collected, and used to~     help determine device safety. These implants are investigational devices.~      Approximately 300 patients at centers across the United States will be enrolled in this~     research study, by up to 30 sites. These patients will be implanted with Becker~     Expander/Breast Implant and monitored for 10 years to collect information on risks associated~     with the implant surgery as well as changes in the way these patients feel about themselves.~   "
214606|NCT00750672|"~     The purposes of this study are to examine the needs (symptoms, support, information) and~     satisfaction of women during follow-up in the community after completing treatment for~     endometrial cancer. This information will be collected from the perspective of the women~     themselves, their primary care providers (family physician or gynecologist) and the health~     care providers (oncologist, nurses, social worker, psychologist) at the cancer centre.~   "
214607|NCT00750659|"~     Current therapeutic results in advanced chronic myeloid leukemia (CML) and Ph+ acute~     lymphoblastic leukemia (ALL) are rather disappointing. Most of these patients will eventually~     undergo allogeneic stem cell transplantation. Nilotinib is a novel TKI tyrosine kinase~     inhibitor with 30 fold more potency than Imatinib. Based on previous preliminary experience~     the author we rationalize that Nilotinib therapy pre- allogeneic transplantation for patients~     with advanced CML and Ph+ALL will reduce tumor mass pre- transplant achieving a state of~     minimal residual disease (MRD) and therefore may improve transplantation outcome without~     increasing toxicity. In addition it will allow time for improving patient medical condition~     and for finding an unrelated donor which will enable allogeneic transplantation , and to~     induce anti tumor effect post PBSC w\o DLI ( donor lymphocyte infusion)~   "
214608|NCT00750646|"~     This study is interested in monitoring how patients take eye drops, both through~     video-recordings and adherence monitoring, as well as their perceptions about their eye~     medications; including the dosing schedules, instillation techniques and effect on their~     disease.~   "
214609|NCT00750633|"~     The purpose of this study is to determine if an otic formulation is safe and effective for~     the treatment of acute otitis externa (AOE).~   "
214610|NCT00750620|"~     The objective of this study is to assess and compare the pharmacokinetic properties of YM178~     in normal subjects and those with mild, moderate and severe renal impairment.~   "
214611|NCT00750594|"~     This study will be the first to provide data about the relationship between PFO and migraine~     in children. By establishing the actual prevalence, we will better understand if PFO plays a~     role in the occurence of pediatric migraine and, thus, provide the incentive to perform~     additional studies evaluating whether PFO closure is an effective treatment option for~     pediatric migraine. For children with migraine headaches, discovering novel and effective~     treatments would be life altering.~   "
214612|NCT00750581|"~     A large patent ductus arteriosus (PDA) is associated with congestive heart failure, pulmonary~     hemorrhage, chronic lung disease (CLD), necrotizing enterocolitis (NEC) and intraventricular~     bleeding. Indomethacin is the first line of treatment for PDA. Failure of ductal closure with~     the first course of indomethacin is reported in 30-40% of infants, with a higher failure rate~     in infants weighing < 1000 gm. PDA ligation is associated with early postoperative~     hypotension, oxygenation failure and adverse neurodevelopmental outcome in preterm infants.~     The use of escalating doses of Indomethacin in the treatment of persistent PDA was found to~     be safe and decreased the need for PDA ligation without adverse effects in one observational~     study.We hypothesize that the use of an escalated dose of intravenous indomethacin will~     result in an increase in the probability of survival without need for surgical ligation of~     PDA as compared to a standard dose indomethacin in newborn infants < 29 weeks of gestational~     age with persistent PDA.~   "
214613|NCT00750568|"~     Terbutaline is a medication that is used to treat serious asthma attacks (status~     asthmaticus). The purpose of this study is to determine if terbutaline is effective and safe~     when given as a continuous intravenous infusion to children ages 2 years to 18 years of age.~     Children participating in this study are inpatients in the Intensive Care Unit with a~     diagnosis of status asthmaticus and are receiving terbutaline as part of their routine care.~     Blood samples and physiological assessments will be used to determine how the body is using~     terbutaline and how well it is working.~   "
214614|NCT00750555|"~     Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and~     Neck Cancer after treatment with curative intent~   "
214615|NCT00750529|"~     The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in~     over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without~     Alzheimer's medication.~   "
214616|NCT00750516|"~     This study seeks to determine whether the Lactic Acid blood level in a critically ill patient~     must be drawn with a non-tourniquet venipuncture. The null hypothesis is that there is no~     significant difference in Lactic Acid blood level in critically ill patients in a sample~     taken from either with a tourniquet or a non-tourniquet veni-puncture.~      Monitoring of Lactic acid level is helpful in both identifying potentially serious ill~     patients as well as identifying in the ICU patients with high morbidity and mortality.~      When a patient arrives to an Emergency Department and that patient is hypotensive (BP less~     than or equal to 90 systolic), the nursing staff often starts an IV and if possible draws the~     patient's initial blood tests off that first IV site; or if the patient has had an IV started~     in the field by EMS, the nursing staff will draw blood from another site using a tourniquet.~     This initial work up by the nursing staff takes 15 -20 minutes before a physician may see the~     patient. Since the present standard Lactic Acid test must be drawn either by arterial~     puncture or venipuncture without a tourniquet, this test is rarely done as part of their (the~     RNs) initial blood draws.~      This simple impediment of needing to repeat the venipuncture without a tourniquet, especially~     in patients who often have venous access difficulty, delays the identification of appropriate~     patients for early and aggressive management- particularly those with sepsis.~      Our hypothesis is that this requirement for a non-tourniquet blood draw is unnecessary.~   "
214793|NCT00748176|"~     The body shape might have influence on the spinal level. In this research we plan to~     investigate the relationship of abdominal circumference, trunk length and the level of spinal~     anesthesia in obstetric patients during Cesarean section.~   "
214617|NCT00750503|"~     Tata Memorial Hospital has initiated Workplace Tobacco Cessation and Oral Cancer Screening~     Programme in Chemical Industry at Khed, Ratnagiri. Appropriate interventions for tobacco~     cessation will be carried at monthly intervals for twelve months duration. The tobacco~     cessation rates based on history will be validated with the urinary cotinine levels.~   "
214618|NCT00750477|"~     The purpose of this study is to evaluate the effectiveness of Natural Eggshell Membrane (NEM)~     for the relief of pain and stiffness associated with moderate osteoarthritis of the knee and~     to compare the effectiveness of NEM to placebo.~   "
214619|NCT00750464|"~     Collection of thermal images of women with breast tumors in varying degrees of severity in~     order to evaluate and improve Real Imaging's device (RI3.0) capabilities , which will~     assist in early detection of breast cancer.~   "
214620|NCT00750451|"~     Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts~     with in vitro fertilization treatment. The reason is usually obscure. Many empirical~     treatments have been offered without substantial evaluation. Heparin is thought to play a~     role in the embryo implantation process beyond its anticoagulation effects. The proposed~     study aims to assess the effectiveness and safety of empirical administration of low~     molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple~     failed attempts.~   "
214621|NCT00750438|"~     This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as~     propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to~     have direct beneficial effects on the gut, appetite, weight and fat distribution. This study~     will look into these effects by conducting a dose finding study and then a randomised~     controlled study using healthy human volunteers.~   "
214622|NCT00750425|"~     Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the~     body handles the experimental drug cediranib, in patients with advanced cancer.~   "
214623|NCT00750412|"~     The purpose of this study is to compare the TeenScreen intervention to usual care for~     adolescents who screen positive for mental health problems in a pediatric emergency~     department. It is anticipated that adolescents receiving the TeenScreen intervention will be~     more likely to attend a first session of outpatient mental health services within 60 days of~     the initial screening than those receiving the usual care.~   "
214624|NCT00750399|"~     This is a Phase I clinical trial to test the safety and tolerability of intravitreal~     ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for~     patients with choroidal melanoma using the incidence and severity of events criteria.~      The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression~     of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein~     angiography, and optical coherence tomography, as well as visual acuity.~   "
214625|NCT00750386|"~     This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of~     paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage~     Ic-IV ovarian cancer.~   "
214626|NCT00750373|"~     There have been no prospective clinical studies in infective endocarditis comparing early~     surgery with the conventional treatment strategy based on current guidelines. The purpose of~     this prospective randomized trial is to compare clinical outcomes of early surgery versus~     conventional treatment strategy in patients with high embolic risk of infective endocarditis.~   "
214627|NCT00750360|"~     The present study collects data on safety and reactogenicity of the vaccine in the local~     target population (600 or more subjects) as per the requirement of Korean Food and Drugs~     Administration (KFDA).~   "
214628|NCT00750347|"~     Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of~     Paracetamol in healthy volunteers~   "
214629|NCT00750334|"~     This study will be used to determine the maximum tolerated dose of oral clofarabine when~     administered daily for 14 consecutive days repeated every 21 days.~   "
214630|NCT00750308|"~     This study will measure the effect of the agent tadalafil on glucose and insulin homeostasis~     in people with metabolic syndrome in the presence and absence of an ACE inhibitor.~   "
214631|NCT00750295|"~     The primary objective of this study is to assess the safety, tolerability and activity of~     escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.~   "
214632|NCT00750282|"~     The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK~     6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque~     (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein~     accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is~     therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is~     required to visit the study centre during the screening phase, on the PET imaging day and for~     1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7~     days after IMP administration. During the screening phase the subject's medical, neurological~     and surgical history, specific laboratory tests related to AD, MRI of the brain and certain~     neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations,~     vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET~     imaging day before IMP injection and monitored during and after two PET imaging sessions.~     Clinical safety measures will be performed again on the follow-up visit next day. The results~     of PET imaging with IMP will be compared between probable AD patients and healthy volunteers~     (HV). The clinical diagnosis is based on international validated and accepted criteria and~     established after comprehensive clinical and neuro-psychiatric examinations~   "
214633|NCT00750269|"~     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic~     body radiation therapy and to see how well it works in treating patients with stage I~     non-small cell lung cancer.~   "
214634|NCT00750256|"~     A first-time in human study to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of GSK1278863A in healthy subjects~   "
214635|NCT00750243|"~     The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal~     injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.~   "
242967|NCT00374153|"~     The purpose of this study is to look at the effects of assessment, feedback and motivational~     interviewing on alcohol consumption among college drinkers.~   "
214637|NCT00750217|"~     Buprenorphine is an important alternative to methadone in the maintenance treatment of heroin~     addiction. Transfer from methadone to buprenorphine requires a reduction of daily methadone~     dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. The study~     hypothesis states that the transfer from a daily methadone dosage between 60 mg and 100 mg to~     buprenorphine can be carried out without withdrawal using buprenorphine patches (35 micro~     grams per hour) within 12 to 48 hours after last methadone intake.~   "
214638|NCT00750204|"~     The purpose of this study is to compare airway pressure release ventilation (APRV) to~     conventional mechanical ventilation (MV) in patients with acute lung injury (ALI) to~     determine if APRV can reduce agitation, delirium, and requirements for sedative medications.~     We will also compare markers of inflammation in the blood and lung to determine if APRV~     reduces ventilator-induced lung injury (VILI), compared to conventional mechanical~     ventilation.~      The proposed study is a randomized, crossover trial. We plan to enroll 40 patients with ALI~     and randomize to APRV or conventional MV for 24 hours. After this time the patients will be~     switched to the alternative mode of ventilation (MV or APRV) for another 24 hours. To assess~     breathing comfort, at the end of each 24-hour period we will measure the amounts of sedative~     and analgesic medications used. We will also measure the concentrations of markers of~     inflammation in the blood and lung as measures of VILI. Finally, throughout the study we will~     compare the adequacy of gas exchange with APRV compared to conventional MV.~   "
214639|NCT00750191|"~     Each patient was assigned to one of the two groups: IDB or Sham. On the day of the procedure,~     an IV was inserted in pre-procedural area and patient transported to the procedure room. The~     procedure will be completed under fluoroscopy in prone position. Patients were given 1-4 mg~     of midazolam for relaxation before the procedure and, if needed, 50-100 mcg of fentanyl IV~     during the procedure. The patients was randomly assigned to treatment or placebo using~     computer-generated codes maintained in sequentially numbered opaque envelopes. The physician~     performing procedure was informed of the assignment. In IDB group, guided by the fluoroscopic~     imaging, two transdiscal probes was positioned in the posterior annulus using a~     posterolateral, oblique approach. First, two electrically insulated 17G transdiscal~     introducers was used to gain an access to the disc space. Than, two radiofrequency probes~     will be positioned through each of the introducers bilaterally to create a bipolar~     configuration. Placement of the transdiscal probes within the disc annulus will be confirmed~     using oblique, lateral, and anterior-posterior fluoroscopic images. Sham group had their~     introducers and electrodes positioned just outside of the disc. This was also be documented~     using fluoroscopy. Investigator attached the electrodes to inactive heater control device~     that provide a similar auditory and visual experience for the patient. Patients were~     therefore remain blinded to actual treatment and physician performing procedure was not~     involved in patient's follow-up. Patients were awake and communicating with the physician~     conducting the procedure and if pain in legs were present and increased during the procedure,~     the heating protocol would be stopped. Following completion of procedure the patient was~     transferred to recovery and monitored for 45 minutes, then discharged home with instructions.~     The patients were followed over a period of 12 months.~   "
214640|NCT00750178|"~     This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     MK0683 in patients with advanced cancer.~   "
214641|NCT00750165|"~     Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive~     sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single~     positive pressure that has been individualized for the patient to prevent obstructive~     respiratory events. However, the therapeutic pressure may vary by sleep stage and body~     position within a single night and may change over the course of several nights. One approach~     to dealing with this variability is the use of automatically adjusting CPAP that responds to~     patient breathing patterns with alterations in the delivered pressure. This study is designed~     to determine the effectiveness of using the energy spectrum analysis of flow signals to~     automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require~     CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies~     (either split night or full night) the subject will undergo a night of treatment with the~     Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on~     normalization of sleep disordered breathing while treated with the AutoPAP.~   "
214642|NCT00750152|"~     A research study to compare the safety and effectiveness of an investigational medication~     called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris,~     also known as jock itch.~   "
214643|NCT00750139|"~     A research study to compare the safety and effectiveness of an investigational medication~     called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).~   "
214644|NCT00750126|"~     To assess the engraftment of hematopoietic stem cells following reduced-intensity~     conditioning in children presenting with solid tumors or hematological malignancy by~     evaluating post-transplantation chimerism and hematological reconstitution.~      To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune~     reconstitution, post-transplantation To study the effectiveness of the protocol on tumor~     response.~      To study overall survival.~   "
214645|NCT00750113|"~     Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing~     cardiovascular events such as myocardial infarction or stroke. To reduce this risk an~     appropriate antihypertensive therapy should allow to reach a target blood pressure of less~     than 130/80 mmHg in order to maximise cardiovascular protection.The purpose of this study is~     to evaluate the efficacy in blood pressure control when anti-hypertensive therapy is~     initiated with a combination of low dose Nifedipine GITS and Telmisartan compared to a~     regimen starting with monotherapy before adding the other drug.The primary efficacy parameter~     will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring~     (ABPM) at 16 weeks of treatment compared to baseline~   "
214646|NCT00750100|"~     In this study,the investigators compared two protocols for controlled ovarian~     hyperstimulation in infertility patients requiring IVF. In the control group, the patient~     undergoes a standard antagonist protocol. In the study group, the administration of~     gonadotropins is stopped in the late follicular phase and replaced by low dose human~     chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved~     in both groups.~   "
214647|NCT00750087|"~     the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months~     in patients treated with Seroquel XR.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
214702|NCT00749372|"~     A known risk of red blood cell transfusions is that it puts excess iron into the patient's~     body. Researchers are continually seeking the most effective method of measuring iron~     concentration. The purpose of this study is to determine how much iron has been deposited in~     a patient's heart and liver as a result of having received red blood cell transfusions using~     magnetic resonance imaging (MRI).~   "
214648|NCT00750074|"~     There are two fundamentally different ways to ventilate critically ill patients: constant~     flow, volume-preset modes (such as volume assist-control) and pressure-preset modes (such as~     pressure-control and pressure-support). Critically ill patients suffer mechanical~     derangements of the respiratory system that raise the work of breathing. Knowledge of these~     mechanical properties is useful diagnostically and as a measure of response to treatment over~     time. It has been proposed that only constant flow, volume-preset modes are able to offer~     diagnostic information about the changes in the subject's lungs in terms of resistance and~     elastance properties. This study proposes to examine if similar information can be extracted~     from pressure-preset modes by comparing information from both modes of ventilation.~   "
214649|NCT00750061|"~     This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be~     randomized into two groups. The subjects in the Treatment Group will be administered with~     lithium carbonate, while the Control Group will receive placebo.~      Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment~     group, the dose will be adjusted according to the serum lithium level while in the control~     group there will be a sham adjustment.~      The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The~     outcomes will be compared with baseline pre-treatment data to obtain neurological change~     scores. The efficacy and safety will be analyzed comparing the results of the treatment~     group with those of the control group.~   "
214650|NCT00750048|"~     The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic~     effect of paracetamol in healthy volunteer, using evoked potentials.~   "
214651|NCT00750035|"~     Background~      It is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or~     sexual function than total abdominal hysterectomy.~      Methods~      The investigators conducted a randomized, double-blind trial comparing total and subtotal~     abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most~     of the women were premenopausal. The main outcomes were measures of bladder, bowel, and~     sexual function at 12 months. The investigators also evaluated postoperative complications.~   "
214652|NCT00750022|"~     The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC)~     within a comprehensive weight reduction program. Will individuals that receive a personalized~     nutrition program, at baseline, from IC technology respond better to treatment compared to~     individuals receiving IC technology at three months.~   "
214653|NCT00750009|"~     RATIONALE: Providing information that is tailored to answer patients' questions about~     clinical trials may help patients with cancer decide to enroll in a clinical trial. It is not~     known whether providing personalized information is more effective than basic information in~     helping patients make decisions about clinical trials.~      PURPOSE: This randomized phase III trial is studying personalized information to see how well~     it works compared with basic information in helping patients make decisions about~     participating in a clinical trial.~   "
214654|NCT00749996|"~     The study aims at assessing the short and long-term effectiveness and patient perception of~     benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc~     disease at a single level from L2 to L5.~   "
214655|NCT00749983|"~     The purpose of this study is to determine whether creatine associated or not to exercise~     training can improve physical performance in patients with knee osteoarthritis and~     fibromyalgia.~   "
214656|NCT00749970|"~     Observational, short-term prospective, multicenter study to assess psychometric properties of~     the Spanish version of SWN-K scale in patients with schizophrenia.~   "
214657|NCT00749957|"~     The purpose of the study is to evaluate the safety and efficacy of an adeno-associated virus~     vector expressing RPE65 in patients with Leber congenital amaurosis caused by mutations in~     the RPE65 gene.~      Funding Source - FDA OOPD~   "
214658|NCT00749944|"~     Study objective is to compare neuropsychiatric adverse events in subjects treated with~     varenicline or placebo in a controlled setting where both groups are experiencing nicotine~     withdrawal.~   "
214659|NCT00749931|"~     The purpose of this study is to show that addition of device use to a routine breast cancer~     tumor excision procedure is beneficial and assists the surgeon in correctly determining the~     extent of excision.~   "
214660|NCT00749918|"~     This study was intended to evaluate the effect of vitamin D supplementation on insulin~     sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D~     supplementation to normal levels in patients with impaired fasting glucose will result in~     improved insulin sensitivity and improved beta cell function.~   "
214661|NCT00749905|"~     A prospective randomized controlled investigator-blinded study to compare efficacy of low~     fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and~     standard bowel preparation for colon capsule examination~   "
214662|NCT00749892|"~     The goal of this clinical research study is to learn if Tarceva™ (erlotinib hydrochloride;~     OSI-774) can help to shrink the tumor or slow its growth, before surgery, in patients with~     transitional cell carcinoma.~   "
214663|NCT00749879|"~     This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50~     mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers~     in the fed and fasting states.~   "
214664|NCT00749866|"~     The hypothesis of this randomized placebo controlled trial is that targeted nebulized~     gentamicin to the airways will reduce bacterial burden and limit neutrophil airways~     inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise~     capacity and health related quality of life with a reduction in exacerbation frequency and~     health care utilization.~   "
214672|NCT00749762|"~     This study seeks to determine in Neonatal Intensive Care Unit (NICU) patients specific~     improvements in pulmonary function which may occur when an infant is ventilated in the prone~     as compared to the supine position. Modest improvement in oxygen has been reported to occur~     with prone positioning, but the exact etiology for this change is not clear. A special~     incubator designed as an integrated care system allows routine care and the measurement of~     both patient and ventilator breaths during mechanical ventilation. This study will utilize~     this device to evaluate in NICU ventilated patients whether specific changes in pulmonary~     function accompany position changes, and whether these are correlated to a change in~     pulmonary gas exchange.~   "
214665|NCT00749853|"~     Available data from in vitro studies and clinical trials indicate that genetic factors play a~     significant role in the success of controlled ovarian stimulation (COS) prior to in vitro~     fertilization - embryo trandfer (IVF-ET). Women with the FSHR Ser680Asn Ser/Ser genotype make~     up between 13% and 26% of women undergoing IVF-ET and are characterised by higher basal FSH~     serum concentrations, the need for a higher amount of FSH for COS, and a higher risk of poor~     response to COS and cycle cancellation.~      The investigators therefore intend to perform a study to investigate whether a~     dose-intensified COS protocol based on FSHR genotype status in women with the FSHR Ser680Asn~     Ser/Ser genotype is more effective than routine management in terms of~        -  the mean number of follicles~        -  the mean number of embryos~        -  the rate of poor responders~        -  the rate of women with cycle cancellations, and v) the clinical pregnancy rates.~      Eligible women will be randomized to a stimulation protocol characterised by a longer~     duration and increased dosage of FSH stimulation (group A) or a standard stimulation protocol~     (group B).~   "
214666|NCT00749840|"~     Through a prospective observational cohort study enrolling patients newly diagnosed with~     Human immunodeficiency virus (HIV):~      Aim 1: Assess attitudes and beliefs about HIV disease and care over time and relate those~     attitudes and beliefs to success in following the Steps of HIV Care.~      Aim 2: Validate a simple visual analogue scale for assessing adherence to highly active~     antiretroviral therapy (HAART) in patients newly starting HAART in routine care.~      Aim 3: Implement latent growth curve analysis for modeling changes in attitudes and beliefs~     over time, and for assessing the impact of the components of the Steps of HIV Care model on~     health outcomes.~   "
214667|NCT00749827|"~     Contrast induced nephropathy (CIN) is a term applied to acute renal failure associated with~     intravascular injection of iodinated contrast agents typically used for cardiac angiography.~     CIN occurs in about 15% of those who have had cardiac angiography, with dialysis required by~     about 0.5% of cases. The development of CIN is associated with other adverse outcomes~     including major adverse cardiovascular events (MACE) and death. The mechanism underlying the~     association with MACE and death is unclear and it is largely unknown whether measures~     reducing the frequency or severity of CIN also reduce these associated adverse events.~      The cause of CIN in humans is not known, but many preventive therapies have been tested based~     on our understanding of the mechanism underlying CIN from animal models. Despite multiple~     studies, no one drug or therapy has been proven to consistently prevent CIN at this time.~     Prophylactic fluid therapy is uniformly recommended as a component of preventive approaches~     for CIN. However, the optimal type, dose and duration of fluid therapy remain unclear.~     Existing studies suggest a role for isotonic saline[3] or bicarbonate[4]. Initial use of~     hypotonic fluid followed by isotonic fluid might allow a more rapid and sustained increase in~     tubular fluid flow by suppression of ADH. This should assist in reducing tubular fluid~     viscosity and the potential for injury by contrast medium.~      The aim of this research program is to design and test strategies for the prevention of CIN~     in patients undergoing elective cardiac angiography or percutaneous coronary intervention~     (PCI). The primary purpose of this pilot study will be to determine the biological~     plausibility of using a hypotonic solution for CIN prophylaxis.~      Specific Objectives:~      Primary~        1. To compare the effects of two fluid prophylaxis strategies for CIN on urine output,~          urine pH, urine composition (urine metabolic profiling), a novel marker of renal injury~          (NGAL) and urine osmolality Secondary~        2. To assess the relative sensitivity of definitions of CIN based on changes in serum~          creatinine or cystatin C within 72 hours post contrast.~        3. To determine the feasibility of a future multicenter randomized trial of a hypotonic~          fluid prophylaxis strategy for the prevention of radiocontrast nephropathy.~   "
214668|NCT00749814|"~     Background~      Sleep disturbances are prevalent in hospitalized adult patients manifested as reduced sleep~     time and sleep efficiency as well as increased awakenings. Insomnia is the most frequent~     sleep disturbance. The effect of the change in sleep patterns in children prior to and after~     an elective surgery has not been evaluated objectively. Sleep in hospital may influence~     biological processes related to circadian rhythm.~      Melatonin is a hormone secreted by the pineal gland in a diurnal rhythm regulated by light-~     light suppresses melatonin secretion, while darkness enhances it. Melatonin has both~     chrono-biotic and sleep promoting properties. Exogenous administration of melatonin shortens~     sleep latency, increases sleep efficiency and total sleep time. Melatonin also improves~     disrupted circadian rhythm. Melatonin promotes sleep in a similar way to the natural sleep~     process, and maintains normal sleep architecture.~      Melatonin has a positive effect on children with sleep disturbances and is routinely~     administrated in pediatric sleep centers around the world for insomnia and a variety of sleep~     disorders. Side effects of melatonin are rare and scarce. Circadin is a slow released~     formulation of melatonin, which mimics night time secretion of natural melatonin. Children~     with sleep disorders who were treated with controlled release melatonin, demonstrated~     improvement in sleep latency and total sleep time.~      It is reasonable to assume that hospitalized children have disturbed sleep patterns prior to~     and following elective surgery. We hypothesize that melatonin will improve sleep patterns~     prior to and following surgery, by reducing sleep latency and extending total sleep time. We~     also hypothesize that this improvement will have positive impact on anesthetic stress~     measures and on recovery.~      The purposes of the study are: 1. To characterize sleep patterns in children undergoing~     surgery on the admission night prior to surgery; 2. To evaluate the effect of melatonin on~     sleep parameters on the night prior to surgery in children; 3. To evaluate the effect of~     melatonin on physiologic stress parameters during anesthesia and surgery in children; 4. To~     evaluate the effect of melatonin on sleep parameters of children postoperatively; 5. To~     evaluate the effect of melatonin on postoperative outcome measures in children.~      Patients, Methods. Ninety children (aged 4-18 years) will be evaluated. Sleep disorders will~     be screened by a pediatric sleep questionnaire. Sleep will be assessed by sleep logs and~     actigraphy for sleep onset time, sleep latency, total sleep time, total wake time, number and~     length of awakenings, sleep efficiency, sleep fragmentation index and sleep mean activity~     score. Recovery measures will include: length of hospitalization, infection rate, body~     temperature, cortisol levels, cooperation with medical staff.~      Study plan. The research will comprise of 5 consecutive steps. Step 1 will include the week~     prior to surgery and include sleep evaluation to all participants by sleep log and~     actigraphy. Step 2 is the night prior to surgery and will include sleep log and actigraphy.~     30 children will receive melatonin (Circadin) 2mg, 30 children will receive placebo and 30~     children will constitute the control group. Step 3 will be conducted during anesthesia and~     surgery where stress variables and need for anesthesia will be recorded. Step 4 will take~     place during post-operative hospitalization and will include actigraphy and sleep logs. Step~     5 will take place at home two weeks after discharge and will include actigraphy and sleep~     logs.~   "
214669|NCT00749801|"~     Nattokinase, first found by Dr. Hiroyuki Sumi in 1980, is a potent fibrinolytic enzyme~     extracted from Natto, a popular soybean fermented food in Japan. It was confirmed that oral~     administration of nattokinase (or natto) produced a mild and frequent enhancement of the~     fibrinolytic activity in the plasma as indicated by the fibrinolytic parameters and the~     production of tissue plasminogen activator. Other studies also showed a reduction in lipid~     peroxidation and improvement of lipid metabolism. Short-term effect (less then 10 days) of~     oral administration of nattokinase on both animal and human subjects has been studied and~     reported. However, whether nattokinase possesses a beneficial effect to dyslipidemic patients~     remains unclear. The aim of this study is to investigate the long-term effect (six month) of~     the mono and multiple formulae of nattokinase, change of BP, lipid and fibrinolytic factors~     from baseline and 6 months on dyslipidemic patients.~   "
214670|NCT00749788|"~     The purpose of this study is to determine the effect of JTT-302 on the increase of High~     Density Lipoprotein-Cholesterol (HDL-C) levels when administered daily for four weeks in~     subjects with low HDL-C levels.~   "
214671|NCT00749775|"~     To collect the efficacy and safety information of Eplerenone on patients with hypertension~     related to their appropriate use in daily practice.~   "
214673|NCT00749749|"~     The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and~     effective in reducing the amount of narcotic pain medication needed to control pain during~     the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op~     Pain Relief System.~   "
214703|NCT00749359|"~     This study is to determine if controlled release paroxetine tablets manufactured at two~     different sites behave similarly in healthy volunteers.~   "
214674|NCT00749736|"~     Patients with chronic kidney disease (CKD) are commonly deficient in vitamin D, with low~     levels of both calcidiol (25 hydroxy vitamin D) and calcitriol (1,25-hydroxy vitamin D).~     Patients with CKD are also known to have abnormalities in their immune cells, increased~     susceptibility to infection and increased prevalence of malignancies. In patients without~     kidney disease, repletion of vitamin D appears to help some immune mediated diseases. Thus it~     is logical that patients with CKD who are vitamin D deficient may benefit from repletion of~     vitamin D, in either its native form (cholecalciferol/ergocalciferol) or in the form of~     calcitriol or its analogues. However, no interventional data demonstrates that repletion~     positively impacts immune status in CKD patients. To test this hypothesis, a large~     interventional study will be required. However, prior to conducting this study, several~     important steps are needed. The present proposal aims to generate the necessary data to~     appropriately plan and conduct a future multi center interventional study. Specifically, we~     will examine the following specific aims in a population of CKD stage 3 and 4 subjects from~     Indiana University Affiliated Nephrology Clinics and determine~        1. if abnormalities in immune cells and immune blood tests are related to abnormalities in~          vitamin D.~        2. how reproducible these changes are on repeat testing and~        3. if repletion of vitamin D changes these cells and immune blood tests in a small pilot~          study.~   "
214675|NCT00749723|"~     The purpose of this study is to improve overall survival while maintaining a good quality of~     life in pediatric patients with refractory or recurrent brain tumors (medulloblastomas,~     supratentorial PNETs, ependymomas WHO grade II and III). Response to different chemotherapy~     options (intravenous versus oral chemotherapy, intraventricular chemotherapy) as part of a~     multimodal therapy will be assessed. Progression-free, overall survival and toxicity will be~     evaluated additionally.~   "
214676|NCT00749710|"~     Patients suffering from femoral neck or pertrochanteric fractures have a high rate of~     mortality and morbidity associated mainly with deconditioning and immobilization. Surgical~     management including open reduction and internaql fixation has been shown to reduce~     complication and improve outcome in such patients. Delay of surgery produces less optimal~     results and is associated with higher morbidity even after 24-48 hours of fracture event.~      Patients treated with platelet antiaggregants are exposed to higher blood loss during surgery~     and related complications, as demonstrated in patients treated with Aspirin. However,~     cessation of antiaggregant therapy before surgery may be associated with complications of a~     hypercoagulable state and surgery delay.~      Clpopidogrel is a fairly new approved antiaggregant drug indicated in cases of failed aspirin~     treatment in ischemic heart disease and cerebrovascular disease patients as well as in~     primary prevention of stent restenosis.~      No data regarding complications of hip surgery in patients treated with Clpopidogrel is~     available.~      Study hypothesis:~      Definitive surgical treatment of patients treated with clopidogrel undergoing open reduction~     and internal fixation of pertrochnteric and femoral neck fractures is safe although~     associated with more extensive blood loss during surgery and postoperative wound~     complications.~   "
214677|NCT00749697|"~     The main purpose of the study is to establish a relationship between the administered~     activity of the radioiodine and absorbed dose in the tumor sites.~   "
214678|NCT00749684|"~     The aim of this observational study is to document the efficacy and tolerability of high-dose~     interferon therapy in adult participants with malignant melanoma at high risk of relapse and~     to compare them with the survival times and relapse rates in previous studies (historical~     control).~   "
214679|NCT00749671|"~     BACKGROUND Physician-guided moderate sedation, administered by a Registered Nurse has been~     the standard of practice for patients undergoing a wide range of electrophysiology procedures~     during the past decade. Currently a subjective sedation assessment tool is the standard of~     practice within the Electrophysiology Lab (EP Lab). Bispectral Index monitoring (BIS) is an~     objective measure of the depth of sedation presently employed at Baystate Medical Center in~     the Intensive Care Unit and within the department of anesthesia.~      AIM The aim of this research study is to assess the utility of BIS monitoring in measuring~     the depth of sedation in patients undergoing defibrillation threshold testing (DFT). Our~     primary endpoint is: A change in OAAS scores of one point at the 30 minute data collection~     time period.~      Our secondary endpoints are: Lack of explicit recall of DFT testing and measurement of~     perioperative level of comfort.~      STUDY DESIGN AND SCOPE The population to be studied is those patients receiving a primary ICD~     implant or an ICD battery change with defibrillation threshold testing (DFT).~      All patients who have consented for ICD placement and DFT testing with moderate sedation will~     be invited to participate in this research study. Patients who are not candidates for DFT~     testing, as is determined by the EP physician, will be excluded from the study.~      Demographic data including: age, gender, BMI, current medications and history of sleep apnea~     will be collected. Data detailing the amount of drug administered during the procedure and~     any use of reversal agents, will be retrieved from the medical record.~      The study will be conducted within the Electrophysiology lab at Baystate Medical Center. An~     enrollment of 60 subjects is expected to be completed within 6 months. 30 patients will~     originate from the outpatient population and 30 from the inpatient.~      Follow up assessments using the OAAS scale will be completed at 30 min, 1 hour and 4 hours~     post procedure. Also, perioperative comfort and recall of DFT testing will be assessed at the~     4 hour mark.~   "
214680|NCT00749658|"~     The objective of this proposal is to elucidate effects of bupropion SR + varenicline on~     smoking-cessation related processes in early abstinence using a human laboratory model. A~     within-subjects design will be used to assess the additive effects of bupropion and~     varenicline in 48 treatment seeking smokers [bupropion SR (300 mg/day)+placebo, varenicline~     (2 mg/day+placebo, and bupropion SR (300 mg/day)+varenicline (2 mg/day)]. Outcomes include~     withdrawal and craving, cognition, stress tolerance, anxiety, the reinforcing effects of~     smoking, and smoking topography.~      Hypotheses: We hypothesize that greatest treatment effects will be observed in the bupropion~     SR+varenicline group followed by varenicline+placebo and bupropion SR+placebo groups.~   "
214681|NCT00749645|"~     This is a Clinical Pilot Phase II interventional, double blind, randomized and placebo~     controlled study to document the efficacy, tolerability and safety of FANG(30) in 60 adult~     patients affected with active Rheumatoid Arthritis. Also, to evaluate the effect of an~     andrographolide natural formula, identified as FANG(30) or the study product, on the~     immunological functions that influence chronic inflammatory process in these patients, who~     could benefit with this treatment.~   "
214682|NCT00749632|"~     The purpose of this study is to determine the safety of three doses of oxybutynin for the~     treatment of urge urinary incontinence.~   "
214683|NCT00749619|"~     Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the~     vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled~     Cuffed Catheter(TCC) as vascular access.~   "
214684|NCT00749606|"~     The purpose of this study is to determine if primary care based, telephone-delivered weight~     loss interventions are effective.~   "
243745|NCT00363844|"~     Determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes~     mellitus who have inadequate glycemic control on diet/exercise therapy~   "
214685|NCT00749593|"~     Congenital Adrenal Hyperplasia (CAH) is one of the commonest inherited diseases, affecting~     1:14,200 live births. It is the result of a genetic defect in one of the enzymes (in most~     cases 21-hydroxylase) required for cortisol biosynthesis, leading to reduced levels of~     cortisol and aldosterone, increased ACTH concentrations and consequently increased adrenal~     androgen production. Patients suffer from problems with growth and development and as adults~     patients may have problems with fertility, virilisation in women, testicular masses in men~     and both men and women have an impaired quality of life. Patients have to take life-long~     therapy. Despite its frequency knowledge surrounding the management of adults with CAH~     remains fairly limited. There has been a lot of work describing the management of children~     with CAH but to date there is no consensus on how to manage adults. To address this issue a~     number of adult endocrinologists in the UK under the auspices of the Society for~     Endocrinology have established a country wide study (CaHASE) to undertake research in order~     to set standards of care for adult patients with CAH.~      In CAH the severity of the symptoms experienced by affected individuals varies depending on~     the mutation and the genetic background of the individual. The ability to tailor CAH therapy~     on an individual basis, as determined by the severity of the underlying defect and an~     understanding of the likely natural history of the disease, is a key goal in clinical~     management. Correlation of phenotype (clinical status) and genotype (the underlying 21~     hydroxylase gene mutation) will facilitate stratification of severity and provide an~     important contribution to the debate on potential mechanisms of individualised therapy. For~     instance it may become clear that certain CAH genotypes are associated with specific long~     term outcomes. In time, this could lead to suggesting different treatment strategies in~     certain groups. Moreover, genotype data are important if we are to address the relative~     contribution of environment (e.g. treatment) vs. genetics on long term outcomes.~      This multi-centre study aims to:~        1. - Investigate the medical health of adults with congenital adrenal hyperplasia.~        2. - Investigate the relationship between the genotype of the patient and the phenotype.~        3. - Investigate the quality of life of adults with congenital adrenal hyperplasia.~   "
214686|NCT00749580|"~     The purpose of this study is to determine whether raltegravir 400 mg b.i.d. in a boosted PI~     regimen is as efficacious and safe as the NRTI backbone in a boosted PI regimen.~   "
214687|NCT00749567|"~     The purpose of this study is to evaluate the efficacy and toxicity of combination of~     erlotinib and bevacizumab in patients with locally advanced or metastatic, non-squamous~     non-small cell lung cancer, who progressed after first line treatment. Pretreatment with one~     of the two agents would not excluded patients from the study, in order to evaluate whether~     the combination of the two biologic agents could reverse tumor resistance.~   "
214688|NCT00749554|"~     The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc~     Biacuplasty in relieving pain, reducing medication intake and improving function,~     satisfaction and quality of life of patients with chronic mechanical discogenic low back~     pain.~   "
214689|NCT00749541|"~     decreased vitamin d levels are associated with increased inflammatory markers,and renin~     angiotensin levels.~      decreased levels were also found to be connected to increased cardiovascular mortality.~      we therefore hypothesise that in patients with pathological results of coronary~     catheterization we will find decreased levels of 25 hydroxy vitamin d.~      we will examine patients undergoing elective coronary catheterization and compare two groups:~     those with normal results and those with pathological results.~   "
214690|NCT00749528|"~     The purpose of this study is to evaluate hair trace elements and toxic metals and plasma~     total antioxidant activity in children with recurrent wheezing and to evaluate whether these~     toxic metals and trace elements have any impact on serum cytokine levels.~   "
214691|NCT00749515|"~     This purpose of this study is to understand the differences between people who have a good~     response to deferasirox (exjade) compared to people who have a poor response to this~     medication when used for transfusion-dependent iron overload.~      The hypothesis is that patients with poor responses have physiologic barriers to deferasirox~     that may include absorption, pharmacokinetics of drug metabolism, hepatic clearance and/or~     genetic factors.~   "
214692|NCT00749502|"~     This is a four-part dose-escalation and confirmation study in participants with advanced~     solid tumors. Part A is for dose escalation and determination of maximum tolerated dose (MTD)~     and recommended Phase 2 dose (RP2D) of MK-4827. Part B is a prostate/ovarian cancer cohort~     expansion. Part C is for a cohort of participants with relapsed or refractory T-cell~     prolymphocytic leukemia (T-PLL) or chronic lymphocytic leukemia (CLL). Part D will be for a~     cohort of participants with locally advanced or metastatic colorectal carcinoma (CRC),~     persistent or recurrent endometrial carcinoma, locally advanced or metastatic triple negative~     or highly proliferative estrogen receptor positive (ER+) breast cancer, or partially~     platinum-sensitive epithelial ovarian cancer. The study is also designed to find out whether~     MK-4827 causes at least 50% inhibition of poly adenosine diphosphate ribose polymerase (PARP)~     enzyme activity.~   "
214693|NCT00749489|"~     The purpose of this study is to compare two different methods of treating pain after a hip~     fracture.~   "
214694|NCT00749476|"~     The purpose of this study is to collect data around the period of the conversion from~     plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a~     retrospective history of the bleedings in the 3-month period before the conversion, the~     recovery with pdFIX just before the conversion and with BeneFIX just after the conversion,~     and a prospective history of the bleedings in the 3 month period following the conversion.~   "
214695|NCT00749463|"~     To evaluate the safety, smoking cessation and reduction rate during 3 months of active~     nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital~     physicians and staff who are motivated to quit~   "
214696|NCT00749450|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and capecitabine,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. It is not yet known which combination chemotherapy regimen is~     more effective in treating patients who have undergone surgery for high-risk colorectal~     cancer.~      PURPOSE: This randomized phase III trial is studying chemotherapy given after surgery in~     treating patients with high-risk stage II or stage III colorectal cancer.~   "
214697|NCT00749437|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Placing gold~     markers in the area where the tumor was removed may help doctors better direct radiation~     therapy and help reduce the risk of cancer recurrence.~      PURPOSE: This phase I trial is studying how well radiation therapy using gold markers works~     in treating women with early-stage breast cancer.~   "
214698|NCT00749424|"~     The objective of this study is to compare the safety and effectiveness of two different~     approaches to treat bifurcational lesions with CYPHER SELECT™ Sirolimus-eluting~     Balloon-expandable Coronary Stent , Cordis Corp): a) the crushing technique to stent both~     branches vs. b) a provisional T stenting technique of the side branch.~   "
214699|NCT00749411|"~     The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the~     combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.~   "
214704|NCT00749346|"~     An open-label phase I-II trial will be performed in 42 patients with pretreated locally~     advanced non-small cell lung cancer. The trial is designed to estimate the efficacy and to~     determine safety of NovoTTF-100L treatment combined with Pemetrexed for advanced NSCLC~     patients. Patients will receive standard Pemetrexed therapy (at 500 mg/m2 iv q3w for 3~     cycles) concomitant to NovoTTF-100L therapy (12 hours a day, daily until the end of all three~     cycles of Alimta). Repeat treatments with Alimta + NovoTTF-100L will be offered as long as~     the patient is stable or responding. If there is a in-field response with progression outside~     of the NovoTTF field, Pemetrexed is to be stopped and third line chemotherapy with Docetaxel~     is to be initiated (35 mg/m2 weekly, d1, 8, 15, q 28 d).~   "
214705|NCT00749333|"~     The purpose of this study is to determine how well tolerated and safe AZD8566 is at different~     dose levels. This study will also determine how AZD8566 is distributed around the body and~     how it leaves the body.~   "
214706|NCT00749320|"~     The purpose of this study is to assess magnetic resonance imaging (MRI) as a tool to track~     tumor growth for renal cell carcinoma while the participant is receiving clinical treatment~     therapy with sunitinib or pazopanib. An MRI is a sophisticated type of scan that uses~     powerful magnets to make clearer images or to focus on detailed medical information in the~     participants abdomen and pelvis. This imaging done for this study will use the ASL MRI~     technique that allows us to see blood flow changes which possibly may indicated tumor growth.~   "
214707|NCT00749307|"~     The purpose of this study is to test the hypothesis that dietary supplementation with an~     algal source of docosahexaenoic acid (DHA) can improve the heart rate variability in elderly~     patients.~   "
214708|NCT00749294|"~     The study will be a prospective study of patients presenting with anogenital warts. The~     objective are to assess proportion of anogenital warts to the total number of sexual~     transmitted infection patients, to quantify direct and indirect cost of illnesses and~     psychological burden associated with anogenital warts and to estimate government program~     expenditure for the prevention and control and treatment of the STI/anogenital HPV infection.~   "
214709|NCT00749281|"~     Serum NGAL has been described as a biomarker of neutrophil activation and an inflammatory~     marker which correlates to obesity and its metabolic complications. Since neutrophil~     activation has been implicated in the pathogenesis of coronary artery disease, the~     investigators hypothesized that serum NGAL levels would be higher in patients with CAD and~     that serum concentration would correlate with the extent of CAD as documented by coronary~     angiography, serving as a potential biomarker of the severity of CAD.~   "
214710|NCT00749268|"~     The objective of this study is to assess pain that occurs following hernia repair that is~     related to mesh fixation. The study is designed to see if there is any difference in pain~     after surgery between absorbable and permanent methods of mesh fixation in inguinal and~     ventral hernia repair.~   "
214711|NCT00749255|"~     The purpose of this case collection effort is software design by R2 Technologies, Inc., The~     information received from Women's Imaging will be provided to the Case Collection, Data~     Management and Algorithm/software design and development teams who are responsible for the~     receipt of patient data and management of such data; and creation, testing and validation of~     R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving~     software design.~   "
214712|NCT00749242|"~     This study will compare two treatments in acute stable traumatic vertebral fractures (types~     A1, A2 and A3.1 in MAGERL Classification). The two treatments are the followings:~        1. Conservative Orthopedic Management consisting of brace and pain medication.~        2. Percutaneous Balloon Kyphoplasty, a variant of Vertebroplasty, in which a balloon is~          first placed into the fractured vertebra and inflated with fluid in order to create a~          cavity. This may restore part of the vertebral height loss due to the fracture and~          facilitate the injection of the cement with low pressure.~      The primary outcome will be the variation in the angle of Regional Vertebral Kyphosis (or, in~     the case of asymmetrical fractures, the angle of lateral vertebral inclination) between~     inclusion and one year follow-up. It will indicate if Balloon Kyphoplasty is able to restore~     vertebral height of the fractured vertebra better than Conservative Orthopedic Management.~   "
214713|NCT00749229|"~     Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL~     classification) may undergo unpredictable secondary displacement. Such fractures require a~     two session surgery with a first operation carried out immediately to achieve posterior~     fixation and a second surgery which is performed some days later to stabilize the anterior~     spine and restore stress resistance.~      Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore~     anterior spine strength and replace second session surgery.~   "
214714|NCT00749216|"~     The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK)~     and pharmacodynamics (PD) of multiple dosing Solanezumab in subjects with mild-to-moderate AD~     in Japanese population.~   "
214715|NCT00749203|"~     The objective of the proposed study is to test if a single IV dose of ketamine (0.5 mg/kg)~     decreases symptoms of PTSD.~   "
214716|NCT00749190|"~     The objective of the current study is to investigate the efficacy, safety and~     pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on~     therapy to on going metformin therapy in patients with T2DM with insufficient glycemic~     control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM)~     as add-on therapy to metformin.~   "
214717|NCT00749177|"~     1. Purpose~             1. Provide a culturally sensitive and supportive treatment environment for children,~               youth and families in the aboriginal community experiencing stress, anxiety and~               depression.~             2. Gain insight into understanding of the role of Traditional Healing options provided~               by Aboriginal Healers and Helpers in the management of stress, anxiety and~               depression.~             3. Encourage Aboriginal and First Nation clients to seek treatment earlier from a~               culturally supportive system.~        2. Hypothesis~      This will be a descriptive hypothesis generating research project, however it is anticipated~     that members of the Aboriginal community experiencing stress, anxiety and depression may~     experience improved care and outcomes if their treatment includes traditional healing~     methods. A number of measures of subject and treatment characteristics, stress, anxiety and~     depression will provide the foundation for triangulation of outcomes in order to describe the~     impact of the various treatment options (standard care, Traditional Healing, combined~     standard care and Traditional Healing).~   "
214718|NCT00749164|"~     Now it is commonly accepted that MSC produce an immune-tolerant environment in different~     settings. It has been shown (mainly for BM-MSC) that MSC can down-regulate T cells~     activation. This characteristic of BM derived MSC already has clinical implications and shows~     their potent effectiveness both in prophylaxis and treatment of resistant GvHD. Ongoing~     clinical trials of use bone marrow MSC for treatment of steroid resistant GvHD are~     successfully run on and some bone marrow donor registries included BM-MSC as a material for~     donation. According to our preclinical studies MSC from cells from marrow, placenta,~     umbilical cord vessels demonstrate similar pronounced immunosuppressive effect both with~     autologous and allogeneic lymphocytes. Our preliminary clinical experience shows that BM-MSC~     is an effective tool for treatment of steroid resistant GVHD. Present study aimed to~     demonstrate if human UC-MSC has in vivo immunosuppressive effect and can be used for GVHD~     treatment~   "
214719|NCT00749151|"~     An estimated 47 million adult Americans smoke. The American Lung Association has launched a~     reactive telephone help line to assist in smoking cessation. The proposed study will evaluate~     its effectiveness in a randomized controlled trial design involving active smokers who call~     this helpline. Eligible callers will be randomized into two groups: those who receive~     self-help literature only (i.e. control group) and those who receive additional reactive~     telephone counseling (i.e. study group). Detailed information will be collected proactively~     by an independent research calling specialist from all subjects who enroll into the study, by~     way of follow-up telephone calls, at one, three, six and twelve months following the screen~     date. The outcome measures to be compared are abstinence rates, quit attempts, changes in~     extent of smoking and behavioral stage, and cost-effectiveness. A thousand subjects will be~     enrolled in the two study arms in equal numbers over a period of fifteen months. Intent to~     treat analysis will be used after adjustment for covariates. The significance of this study~     lies in establishing the public health importance of such a reactive telephone helpline as a~     low intensity and low cost interventional smoking cessation tool.~   "
214720|NCT00749138|"~     A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in~     chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.~   "
214721|NCT00749125|"~     This study will examine activation of a brain circuit that regulates emotion in depressed~     patients before and after treatment to see which areas of the brain are involved in chronic~     depression.~   "
214722|NCT00749112|"~     The purpose of this study is to determine whether the combination of low doses of alemtuzumab~     and rituximab are effective in the treatment of patients with autoimmune cytopenias who has~     failed on steroids, relapsed after steroids withdrawal or required continuous steroids~     treatment.~   "
214723|NCT00749099|"~     The overall purpose of this research is to demonstrate (or measure) the intestinal~     availability of lipase, amylase, and protease (enzymes the body has a shortage of) from~     PANCRECARB® when administered with a meal.~   "
214724|NCT00749086|"~     This study aims to compare two treatments in subacute (more than 6 week duration)~     non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the~     following:~        1. Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of~          polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement)~          through a posterior route through the vertebral pedicles under radiological guidance.~        2. Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach~          under radiological guidance, into the fractured vertebra a balloon which is inflated~          with fluid and creates a cavity. This may restore part of the vertebral height loss due~          to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement is~          injected with low pressure into the created cavity to fix fracture reduction. The study~          will indicate if balloon kyphoplasty is able to restore vertebral height of the~          fractured vertebra better than vertebroplasty.~   "
214725|NCT00749073|"~     This is a single-center, open label, prospective clinical study to assess the clinical~     application and functional outcomes of symptomatic patients undergoing the Minimally Invasive~     Lumbar Decompression (MILD™) treatment for lumbar spinal stenosis. In this study,~     patient-reported outcomes over a 3 month period following treatment will be collected by the~     investigator. Periodic surveys for each study subject's pain, functional status, quality of~     life and physical examination will track outcomes following MILD™ treatment.~   "
214726|NCT00749060|"~     This study aims to compare three treatments in recent (less than 6 week duration)~     non-traumatic ( usually osteoporotic) vertebral fractures.~   "
214727|NCT00749047|"~     Pioglitazone is an insulin sensitising drug used in the treatment of patients with type 2~     diabetes. In addition to its blood sugar lowering effect, pioglitazone also has a number of~     other beneficial effects, one of which is to reduce the loss of protein in the urine. The~     mechanism of this protein sparing effect of pioglitazone is not fully understood. The~     proposed study will investigate whether pioglitazone has beneficial effects on the filtration~     characteristics of filters in the kidney that are responsible for retaining protein in the~     body. The effect of pioglitazone on the size of the pores in the filters and also the~     electrostatic charge barriers that surround these pores will be investigated. The clinical~     study will involve 12 patients with type 2 diabetes with minimal urine protein loss, taking~     low dose pioglitazone for 3 months. Blood and urine samples will be collected at the~     beginning, mid point and end of the study and used to measure the concentration of specific~     proteins of different size and electrostatic charge. This data will be used to identify and~     characterise changes in the filtration properties of the kidney filters during the study.~   "
214728|NCT00749034|"~     Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing~     BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against TB for~     residents in endemic areas and persons at risk in non-endemic areas. The new live vaccine~     VPM1002 should be at least as potent as the currently used BCG vaccine and should cause fewer~     side effects (Kaufmann, 2007; Grode et al., 2005). It is formulated as lyophilised bacteria~     to be resuspended before intradermal injection. First application of VPM1002 in human male~     volunteers will evaluate its safety, local and systemic tolerability as well as its~     immunogenicity. The study has a dose-escalating sequential design with comparison to~     commercially available BCG. 80 volunteers in Germany will randomly be allocated to 4 groups~     each with 20 volunteers stratified for their history of BCG-vaccination.~   "
214730|NCT00749008|"~     The purpose of this study is to assess the predictive value of generalized movements in~     preterm and term infants who are at risk for development of cerebral palsy. The investigators~     will identify at-risk infants and observe their generalized movements, conduct a two year~     longitudinal follow-up, and interpret the predictive value of the investigators assessments~     based on the diagnosis of cerebral palsy.~   "
214731|NCT00748995|"~     This is a research study examining health effects of the Iraq War, especially those effects~     involving mental health. This study is a follow-up to the Neurocognition Deployment Health~     Study (NDHS), also called Prospective Assessment of Neurocognition in Future Gulf-deployed~     and Gulf-nondeployed Military Personnel: A Pilot Study. The specific purpose of this~     research study is to find out more about the longer lasting effects of war on mood and stress~     symptoms, thinking and reaction skills, and different aspects of day to day life, such as~     work and daily activities. Survey and test results from previous participation in the NDHS~     will be compared to the new information that will be obtained from participants as part of~     this study. The investigators expect that a total of about 817 military personnel and~     military Veterans will participate in the study. There are two parts to this study: (1)~     mail/internet/phone survey and (2) in-person assessment. The investigators will invite all~     NDHS participants who deployed to Iraq to participate in the survey component. The survey~     component of the study involves being interviewed by phone about mood and stress symptoms and~     head injuries and completing written survey questions by either mail or on the internet that~     address basic personal history (such as age, military status, gender, combat injury history),~     mood, stress symptoms, and stressful experiences. The phone interview will take about 2 to~     2.5 hours to complete. The questionnaire part will take about 20 to 30 minutes to complete,~     and can be completed either by mailing back completed questionnaires or by internet using a~     private, individual log-in/password combination. The investigators will invite approximately~     200 selected at random from the larger group of survey responders to take part in the~     in-person assessment. The in-person assessment involves taking a small subset of~     neuropsychological tasks. The tasks will be given on a computer or using paper and pencil.~     Participants will also be asked to complete questionnaires about work, daily activities, and~     health history, as well as basic health measures such as height, weight, blood pressure,~     heart rate, and waist size. Potential participants will be given the option of completing the~     in-person assessment at one of the two study sites (Seattle or Boston), or in a private~     setting in their community (e.g., a hotel small conference room). Altogether, this part of~     the study will take about 120 minutes to 140 minutes to complete.~   "
214732|NCT00748982|"~     To explore if AZD1305 compromises left ventricular performance in patients with left~     ventricular dysfunction~   "
214733|NCT00748969|"~     The purpose of this study is to determine whether growth hormone is a safe and effective~     treatment for short stature in children with Mucopolysaccharidosis type I, II, and VI.~   "
214734|NCT00748956|"~     There is growing evidence that neuropeptides act as neuronal messengers in the brain and have~     diverse functions that may include the regulation of mood and behavior. For example,~     neuropeptide Y (NPY) is thought to play a role in the adaptive stress response. The~     therapeutic application of neuropeptides for psychiatric disorders has been limited by~     difficult and unreliable penetration of the blood-brain barrier (BBB). However, recent data~     suggest that intranasal administration may provide a means of effectively delivering some of~     these neuropeptides to the brain. Thus far it is unclear if this is the case for NPY. The~     aims of this project are:~        1. To evaluate, in 15 healthy male volunteers aged 25-45, the effect of intranasal NPY~          administration (0, 50 and 100 nmol) on its levels in cerebrospinal fluid (CSF), measured~          by means of lumbar puncture using an intraspinal catheter between L4 and L5, and in~          plasma, measured using an intravenous catheter in the forearm. One of the three~          treatments will be administered to each participant in a double-blind fashion. The 0~          nmol condition will serve as the placebo control.~        2. To test the effect of intranasal NPY administration on mood and anxiety.~   "
214735|NCT00748943|"~     Previous research has shown the oxidizing properties and microbiological efficacies of~     chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological~     efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the~     inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary~     periodontal and malodorous bacteria using for 7 days.~   "
214736|NCT00748930|"~     This is a Phase 4, retrospective chart review of subjects that participated in the ATTRACT~     study. Site investigators will conduct a chart review and complete a data collection form.~     The purpose of this study is to describe the treatment used and clinical outcomes of these~     subjects following completion of the ATTRACT trial up until their most recent assessment by~     the treating physicians.~   "
214737|NCT00748904|"~     The purpose of this study is to evaluate patients with cirrhosis of the liver and renal~     failure and determine if the administration of rifaximin as compared to lactulose is~     associated with less frequent and/or slower progression to severe hepatic encephalopathy. If~     one is associated with lower blood ammonia levels. And, if one is associated with lower~     breath hydrogen and methane levels.~   "
214738|NCT00748891|"~     This study is being carried out in patients with advanced solid tumours to assess which of~     two different types of imaging scans best measures activity of an experimental drug called~     Cediranib. The study compares the imaging tests: Dynamic Contrast Enhanced CT (DCE-CT) and~     Dynamic Contrast Enhanced MRI (DCE-MRI). It looks at which of these scans is the most~     accurate and best predicts a response to the treatment. Cediranib is thought to work by~     stopping blood flow to cancers, and both of these scans assess blood flow. Studying the~     response of cancers by measuring changes in their blood flow may provide useful information~     that will guide the way we manage cancers in the future.~   "
214739|NCT00748878|"~     Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3~     platelet transfusions per day being administered while a patient is undergoing ECMO~     treatment. The cause of thrombocytopenia during ECMO largely involves platelet adherence to~     the oxygenator membrane. Platelet transfusions carry risks such as infections with bacteria~     or yeast, and development or worsening of pulmonary hypertension. It is likely that if fewer~     platelet transfusions can be administered during the ECMO run, the cumulative adverse effects~     of platelet transfusions would diminish and patient outcomes improve. In order to better~     understand platelet function during ECMO, the investigators plan to serially determine the~     circulating platelet mass, plasma platelet factor 4 concentration, megakaryocyte mass~     (estimated by plasma thrombopoietin concentration), and platelet function as quantified by~     PFA100. Any patient on ECMO will be eligible for this pilot study of 5 patients. By~     understanding changes in platelet function, we hope to design a future study that may modify~     the frequency or need for platelet transfusions during ECMO.~   "
214740|NCT00748865|"~     To evaluate drop comfort, acceptability, preference and blue profile between two marketed~     artificial tears in both dry eyes and non-dry eye patient population.~   "
214741|NCT00748852|"~     The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or~     12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid~     parameters and CETP activity and mass.~   "
214742|NCT00748839|"~     Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment,~     it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis~     recurrence, amputation and death approaching 52 % at one month if no specific treatment is~     initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to~     permit appropriate management of this rare condition.~      During the acute phase of HIT, clinicians and biologists can only suspect this complication~     with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive~     or specific to confirm or refute thr diagnosis of HIT.~   "
214743|NCT00748826|"~     The goal of this study is to implement instruments that would increase the treating~     physician's awareness of the necessary tuberculosis screening when starting a new patient on~     infliximab (Remicade) therapy who has not reacted sufficiently to disease-modifying~     preparations, including methotrexate.~   "
214744|NCT00748813|"~     Annual trial for registration influenza vaccine with the strain composition for season~     2008/2009~   "
214745|NCT00748800|"~     Adolescents are at risk for HIV because of sexual and drug behavior initiated during this~     developmental period. Adolescents in the juvenile justice system are at increased risk for~     HIV due to higher rates of substance use and psychopathology than their non-offending peers.~     Juvenile justice youth may therefore also be less likely to benefit from frequently used~     skills based interventions. It appears that emotional lability, frequently found in this~     population, disrupts skills learned. This project will implement and evaluate an affect~     management HIV prevention intervention for adolescents in a juvenile drug court program.~     Affect management and general health promotion interventions will be compared to determine~     which intervention best reduces risk behavior among adolescents in the drug court.~   "
214746|NCT00748787|"~     The metabolic syndrome represents a constellation of risk factors associated to the abdominal~     obesity that includes insulin resistance, lipids alterations, high blood pressure etc.~     Several studies support the hypothesis that the intake of soluble fiber might have a positive~     effect in the improvement of such of these risk factors.~      So that, the aim of this study is to evaluate the efficacy of Ispaghula husk in the remission~     of metabolic syndrome in children between 10 to 16 years old.~   "
214747|NCT00748774|"~     The goal of this study is to compare patient ratings of how severe their own symptoms may be,~     with their caregivers' ratings of how severe they think the patients' symptoms may be. This~     will be compared using a questionnaire that is given to patients with brain tumors and their~     caregivers.~      Researchers will also study any effects that these patients' neurocognitive function may have~     on these patients' and their caregivers' ratings of how severe the brain cancer symptoms may~     be.~   "
214748|NCT00748761|"~     This study will examine the way cognitive behavioral therapy changes the structure of the~     brain in patients with obsessive-compulsive disorder and will thereby determine what makes~     cognitive behavioral therapy an effective treatment.~   "
214749|NCT00748748|"~     Diarrhea is a common side effect of antibiotics; it may prolong hospital stay, increase the~     risk of other infections, develop into more serious forms of disease, and lead to premature~     discontinuation of the needed antibiotic. The purpose of this study is to examine the safety~     and effectiveness of a capsule containing Lactobacillus rhamnosus GG in the prevention of~     diarrhea associated with antibiotic use.~   "
214750|NCT00748735|"~     Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy~     (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for~     optimal definition of LV lead position.~   "
214751|NCT00748722|"~     Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM)~     and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast~     reconstruction. With significant variation in the vascular anatomy of the abdominal wall,~     preoperative imaging is essential for preoperative planning and reducing intraoperative~     error.~      The quest continues for optimal preoperative assessment. Computed tomographic angiography has~     recently been proposed as a noninvasive modality for this purpose. It provides the location~     of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.~      In this study we will perform preoperative lower abdominal computed tomographic angiography~     in DIEP flap breast reconstruction patients.~   "
214752|NCT00748709|"~     This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with~     tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR~     activating mutations.~   "
214753|NCT00748696|"~     Age-related sarcopenia is associated with increased morbidity, mortality, disability and~     reduced resistance to metabolic stress. The aim of this study is to assess the effects of~     resistance training, associated or not with oral nutritional supplements, on skeletal muscle~     mass in sarcopenic subjects. This is a prospective randomised controlled single-centre study~     that will last two years, three months for a participant.~      200 healthy elderly (70-80 years old) subjects will be screened for sarcopenia by dual energy~     X-ray absorptiometry. 128 sarcopenic subjects will be randomized into 4 groups:~        -  group 1: controls~        -  group 2: oral nutritional supplement (260 kcal and 20 g protein per day)~        -  group 3: resistance training (3 times per week)~        -  group 4: oral nutritional supplement + resistance training~      Every subject will be assessed at the beginning and at the end of 12 weeks of intervention~     on:~        -  muscle mass (DXA)~        -  muscle function (dynamometers)~        -  hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles~        -  food intake. Ten subjects in group 4 will undergo a muscle biopsy (quadriceps) before~          and after the intervention in order to explore protein and mRNA levels of the mTOR~          pathway, which may be involved in sarcopenia.~   "
214754|NCT00748683|"~     A falling prevention system will be established by RFID location and motion detection.~        -  Using RFID to detect participants' allocation indoor.~        -  Modifying environment parameters such as light, sound, to alert users if them enter a~          place with potential hazards.~      Data exchange models will also developed in this project~        -  Interchanging different data including physiological data and RFID data into a database~        -  establishing interchange protocol according the HL7 standard~   "
214796|NCT00748137|"~     In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised~     controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to~     the use of variable size meals and insulin doses determined with a bolus insulin calculation~     card.~   "
214755|NCT00748670|"~     The primary objective of the study is to evaluate the long-term survival rate of individual~     implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture~     MicroThread™ (Micro-Macro).~      Clinical study recruitment was stopped in year 2000 due to a decision to modify the product~     under study. This was a result of feedback regarding the subjective feeling during the~     installation procedure. There were no safety concerns w/r to the study products. Patients~     already included and treated in the study were monitored for the full duration of the study~     in accordance with the clinical study protocol.~   "
214756|NCT00748657|"~     This phase II trial studies how well bevacizumab works in treating patients with sex~     cord-stromal tumors of the ovary that have come back. Monoclonal antibodies, such as~     bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab~     may also stop the growth of tumor cells by blocking blood flow to the tumor.~   "
214757|NCT00748644|"~     Study of the efficacy of rituximab for maintenance treatment in systemic ANCA-associated~     vasculitis: prospective, multicenter, controlled, randomized comparative study of rituximab~     versus azathioprine~   "
214758|NCT00748631|"~     Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant~     vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the~     vertebral fracture, decrease of pain. This technique also improves patient function. Namely,~     bedridden patients are often able to resume walking in the days following vertebral cement~     injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to~     inject the cement into the diseased vertebral body which shows cortical destruction with~     lower pressure, thereby possibly reducing cement leakage and related complications.~      This is a multicentric, observational prospective study. Patients are evaluated before and~     after the procedure.~      Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of~     malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be~     enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at~     D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient.~      The main evaluation outcome is patient self-global satisfaction regarding the procedure on a~     semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.~   "
214759|NCT00748618|"~     Vitamin D deficiency accelerates vascular risk progression after kidney transplant.~   "
214760|NCT00748605|"~     1. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily~          with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or~          without S-2367 followed by 54 weeks while on a 800 kcal deficit reduced calorie diet~          (RCD) compared with placebo in medically stable and otherwise healthy obese male and~          female subjects~        2. To evaluate the safety and tolerability of 1600 mg/day S-2367 administered orally once~          daily with the morning meal after a 6-week LCD with or without S-2367 followed by 54~          weeks on a RCD compared with placebo in medically stable and otherwise healthy obese~          male and female subjects~        3. To evaluate the steady-state/trough pharmacokinetics of 1600 mg/day S-2367 administered~          orally once daily with the morning meal after a 6-week LCD with or without S-2367~          followed by 54 weeks on a RCD in obese male and female subjects~        4. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily~          with the morning meal during an initial 6-week LCD compared with placebo in medically~          stable and otherwise healthy obese male and female subjects~   "
214761|NCT00748592|"~     This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way~     crossover design. Elderly subjects with primary insomnia who meet screening requirements will~     initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5~     mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a~     polysomnography (PSG) lab.~   "
214762|NCT00748579|"~     The purpose for this study (CY 1124) is to evaluate the effects of CK-1827452, a cardiac~     myosin activator, on myocardial systolic performance, myocardial oxygen consumption, and~     myocardial efficiency in patients with heart failure and to confirm that the unique~     preclinical pharmacological profile of CK- 1827452 is substantially the same in patients with~     heart failure.~   "
214763|NCT00748566|"~     The purpose of this study is to explore the impact of ziprasidone on the distribution of~     metabolic syndrome risk factors in a population of patients presenting with glucose~     intolerance, dyslipidemia and/or elevated waist circumference associated with their current~     antipsychotic medication.~   "
214764|NCT00748553|"~     The purpose of this clinical trial is to test whether treatment of patients with advanced or~     metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in~     good tumor response. All patients enrolling in this study will receive treatment with~     Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and~     performance status. Tumor response will be measured by RECIST criteria.~   "
214765|NCT00748540|"~     The purpose of this investigation is to collect feasibility data to assess the safety and~     efficacy of the Vibrant Soundbridge (VSB), a medical device designed to provide benefit in~     aided hearing thresholds, speech perception and sound quality to certain individuals with~     hearing loss with minimal changes in residual hearing. The VSB is currently indicated for~     adults with moderate-to-severe sensorineural hearing loss. Under the present investigation,~     adults with conductive and mixed hearing losses who are not successful users of traditional~     amplification will be assessed.~   "
214766|NCT00748527|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and decitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It~     is not yet known whether carboplatin is more effective with or without decitabine in treating~     patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.~      PURPOSE: This randomized phase II trial is studying carboplatin and decitabine to see how~     well they work compared with carboplatin alone in treating patients with progressive,~     advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.~   "
214767|NCT00748514|"~     To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the~     potential risk factors of capsular incisions.~   "
214768|NCT00748501|"~     The purpose of the study is to evaluate the effects of the investigational drug, SB-509 on~     progression of the disease in subjects with ALS~   "
214769|NCT00748488|"~     Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle.~     This is caused by a combination of physical impairments and cognitive dysfunction. However,~     regular physical activity in PD is highly desirable, for two reasons. First, physical~     activity has positive generic effects in preventing complications such as cardiovascular~     diseases, type II diabetes mellitus, osteoporosis and certain cases of cancer. Secondly,~     physical activity has additional disease-specific merits in PD such as depression, sleep~     disturbances and constipation. These effects lead to raised quality of life. Furthermore,~     animal studies suggest that physical activity could slow down disease progression.~      Simply informing patients about the importance of physical activity is not enough to initiate~     and maintain an adequate level of physical activity. We propose to develop a physical~     activity promoting program for sedentary patients with PD in order to raise their level of~     daily physical activity.~      Objective: The first aim of the study is to investigate whether a physical activity promotion~     program will result in an increase in physical activity in sedentary patients with PD.~      The second aim is to demonstrate an increase in physical fitness and quality of life.~   "
214770|NCT00748475|"~     The purpose of the study is to examine the effect of alpha-neurofeedback while subjects~     listen to a noise on tinnitus.~   "
214771|NCT00748462|"~     The objective of this study is to investigate the efficacy and side effects of a fractional~     CO2 laser for treatment of acne scar in Asians.~   "
214772|NCT00748449|"~     to evaluate the acceptability of CT-colonography compared to colonoscopy for the detection of~     advanced adenomas in subpopulations at high risk of colorectal.~   "
214773|NCT00748436|"~     The purpose of this study is to examine the effect of betahistine on body weight in obese~     female subjects~   "
214774|NCT00748423|"~     Acute chest syndrome (ACS) is a frequent and potentially life-threatening pulmonary illness.~     It is a complication of sickle cell disease and is the leading cause of death from this~     disease in adults. Several pathologic processes are recognized causes of ACS, including~     infectious diseases, hypoventilation secondary to chest pain, in situ thrombosis and~     pulmonary fat embolism. Inhaled nitric oxide (iNO) has been shown to be a pulmonary~     vasodilatator with minimal systemic effects and has also been shown to improve gas exchange~     in both animal and human acute lung injury (ALI).~      The combined effects of iNO gas of improving pulmonary ventilation to perfusion matching,~     reducing alveolar and systemic inflammation, modulate the course of acute chest syndrome,~     which combine the physiopathology of vaso-occlusive crisis and acute lung injury.~      We hypothesise inhaled NO will improve oxygenation and clinical outcome of sickle cell~     disease patients with acute chest syndrome.~   "
214775|NCT00748410|"~     This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory~     white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be~     contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces~     polymorphonuclear neutrophils (PMN) accumulation in pre-clinical models of colitis.~     99m-Tc-HMPAO scintigraphy is a imaging technique which will be used in this study to observe~     the effect of SB656933 on the migration of PMN to inflamed tissue.~   "
214776|NCT00748397|"~     The primary objective of the study is to evaluate the long-term survival rate of implants and~     prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro)~     using a one-stage surgical procedure.~      Clinical study recruitment was stopped in year 2000 due to a decision to modify the product~     under study. This was a result of feedback regarding the subjective feeling during the~     installation procedure. There were no safety concerns w/r to the study products. Patients~     already included and treated in the study were monitored for the full duration of the study~     in accordance with the clinical study protocol.~   "
214777|NCT00748384|"~     The study purpose is to demonstrate that the target population can receive a packed FORESEE~     HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them~     for changes in the visual field with good specificity. And evaluate the device usage on a~     small scale, at the subjects' homes before a commercial use.~   "
214778|NCT00748371|"~     Aspirin has shown to be beneficial to some patients with certain diseases such as coronary~     artery disease or stroke. We are investigating how aspirin works on regulating platelets and~     thromboxane over time at different doses. We hope to find the best dose of aspirin and/or~     other medications to help people who are at risk for heart attack or stroke.~   "
214779|NCT00748358|"~     as second-line treatment in metastatic prostate cancer, the present study will investigate~     the efficacy of sunitinib (SUTENT) given orally at a dose of 37.5 mg continuously, for 6~     cycles of 6 consecutive weeks .Patients who are still responders after 6 cycles will be~     treated until disease progression, pain progression, unacceptable toxicity or death due to~     any cause.~      Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based~     on individual safety and tolerability.~      Follow-up for up to 1 year from the last dose of sunitinib.~   "
214780|NCT00748345|"~     Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients.~     Additionally, burn patient population exhibits a wide inter- and intrapatient variation in~     drug handling. Several investigations carried out in burn patients treated with e.g.~     fluconazole showed the requirement to increase daily dose in comparison with healthy~     volunteers. However, no pharmacokinetic data are available of caspofungin in the burn~     population. The aim of this investigation is to investigate pharmacokinetics of caspofungin~     in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal~     dose in this population.~   "
214794|NCT00748163|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Sunitinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~     Giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized~     nanoparticle formulation together with sunitinib works as first-line therapy in treating~     patients with stage IV non-small cell lung cancer.~   "
214795|NCT00748150|"~     Annual trial for registration influenza vaccine with the strain composition for season~     2008/2009~   "
243837|NCT00362609|"~     The purpose of this study is to determine whether or not consistent drug levels can be~     achieved in infants with presumed Gastroesophageal Reflux Disease.~   "
214781|NCT00748332|"~     Cardiac cachexia, the main feature of undernutrition in chronic heart failure, usually~     defined as a weight loss over 6% over 6 months, is a proven factor of morbidity and mortality~     in this disease. Its pathophysiology is complex, but proinflammatory cytokines seem to play a~     major role. Omega-3 poly-unsaturated fatty acids, present in fish oil, have proven beneficial~     in patients with coronary heart disease, due in part to their effects on membranes but also~     due to their anti-inflammatory effects, with inhibition of TNF-α and interleukins 1 and 6.~      The aim of this phase III randomized controlled double-blinded study is to assess the effects~     of 8 weeks of a omega-3-enriched protein-energy supplement versus an iso-energetic~     iso-nitrogenous supplement free of omega-3 fatty acids in cardiac cachexia. Thirty patients~     will be included in each group. The main judgment criterion will be maximum aerobic capacity~     (VO2 max), which best reflects aerobic capacity that correlates with muscle mass.~     Anthropometric, biological (nutritional, inflammatory and involved in food intake control),~     cardiac (functional) and quality of life will also be studied. All analyses will be performed~     in intention to treat.~      The investigators expect a significantly higher improvement of VO2 max in the omega-3 group.~      This study could lead to therapeutic advances in a frequent and severe disease.~   "
214782|NCT00748319|"~     The most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and Sezary syndrome.~     The diagnosis of these lymphomas is difficult using current methods, especially because~     numerous benign dermatological conditions can mimick CTCL both clinically and under~     microscopic examination. Recently, the KIR receptor CD158k has been shown to be a marker for~     Sezary syndrome in both the blood and skin. We hypothesize that other receptors from the same~     family may help fro the diagnosis of these lymphomas. To address this issue, we will study~     the expression of all known KIR receptor in the skin of patients presenting with a skin~     eruption, which may correspond to either a cutaneous T-cell lymphoma or a benign~     dermatological disease. The final diagnosis will be established by a panel of experts,~     allowing constitution of 2 groups of patients : the cutaneous T-cell lymphoma group, and the~     benign inflammatory disease group. The expression of the different KIRs will be analyzed in~     both group in a blinded fashion, in order to determine whether one or a several KIRs may be~     differentially expressed.~   "
214783|NCT00748306|"~     The purpose of this study is to determine the safety and usefulness of GSK2190915 in~     asthmatic patients who develop asthma symptoms following being challenged.~   "
214784|NCT00748293|"~     Good colon cleansing is pivotal for achieving speedy and safe colonoscopic examination with~     high adenoma detection rate.Previous studies, including our previous RCT conducted in 2004 to~     2005, have demonstrated that high yield rate can be achieved by on-the-day colon preparation~     with 2000 ml PEG-ELS. Poor patient compliance, however, is the main hurdle to complete~     ingestion of 2000 ml PEG-ELS not only for subjects with lower body weight but also for those~     with normal BMI or body weight.The main cause of poor patient compliance includes abdominal~     pain, bloating, nausea or vomiting during ingestion of cleansing fluid.Though diet~     restriction with low-fiber diet is always advised to every screen before colonoscopy, the~     extent of diet restriction is widely variable and thus influences the degree of colon~     cleansing.~      With commercialized low-residue diet (CLRD), diet restriction will be well controlled and~     variability of colon cleansing can be minimized such that guarantee a colonoscopy with good~     quality. In this RCT, we will compare the compliance of screen during colon cleansing using~     different protocol: namely 2000 ml PEG-ELS vs. 1500 ml plus low-residue diet.~   "
214785|NCT00748280|"~     The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new~     endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference~     treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of~     human permanent molar teeth.~   "
214786|NCT00748267|"~     RATIONALE: Hypnosis may be effective in reducing pain and other side effects in women~     undergoing surgery for breast cancer.~      PURPOSE: This clinical trial is studying how well hypnosis works in reducing pain and other~     side effects in women undergoing surgery for breast cancer.~   "
214787|NCT00748254|"~     The purpose of this feasibility study is to determine if a new emerging technology called~     photoacoustic tomography (PAT) can be adapted for use in humans for the detection of chronic~     rheumatoid arthritis.~   "
214788|NCT00748241|"~     The purpose of this study is primarily to evaluate implant survival rate of Astra Tech~     Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and~     the implants will be loaded four weeks after implant installation (early loading). Marginal~     bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects~     will be followed for three years.~   "
214789|NCT00748228|"~     One goal of this study is to determine whether people with different amounts of~     dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure~     and heart rate. We will also study whether increasing dietary salt improves symptoms during~     upright posture. Finally, we will examine whether the dietary sodium level influences serum~     DBH activity and whether DBH level influences the response to sodium. DBH levels and the~     function of the sympathetic or involuntary nervous system will be assessed in normal~     volunteers and in patients with postural tachycardia syndrome (POTS).~   "
214790|NCT00748215|"~     RATIONALE: Calcium aluminosilicate anti-diarrheal (CASAD) may help treat and prevent diarrhea~     caused by irinotecan. It is not yet known whether CASAD is more effective than a placebo in~     treating and preventing diarrhea in patients receiving irinotecan.~      PURPOSE: This randomized phase II trial is studying CASAD to see how well it works compared~     with a placebo in treating and preventing diarrhea in patients with metastatic colorectal~     cancer receiving irinotecan.~   "
214791|NCT00748202|"~     The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.)~     administration of Berinert P in patients with hereditary angioedema (HAE) to establish a~     second administration mode in cases where i.v. access is not suitable.~      The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic~     study.~      Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert~     P) and than switch to the treatment not administered before.~   "
214792|NCT00748189|"~     The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to~     chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.~   "
230836|NCT00535015|"~     The purpose of this study is to determine whether Betamarc is effective in improving the~     appetite and reversing weight loss in patients with advanced Non-Small Cell Lung Cancer.~   "
214797|NCT00748124|"~     To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in~     the treatment and control of intra and postoperative air leaks following pulmonary resection~     via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to~     conventional closure techniques (i.e. surgical staples or sutures) will be compared to~     conventional surgical techniques alone.~   "
214798|NCT00748111|"~     Sudden death is a natural death occurring within one hour after the onset of symptoms. It~     remains a major public health problem and accounts for 5 to 10 % of the annual total~     mortality ie about 300.000 in the United States. Despite community-based interventions,~     overall survival remains below 5%. Better understanding of the mechanisms causing sudden~     death could allow early identification of high risk subjects and implementation of specific~     prevention strategies. The cause of more than 90% of sudden deaths is cardiac with~     ventricular fibrillation or fast ventricular tachycardia complicating an underlying heart~     disease. Coronary heart disease and its consequences account for at least 80% of sudden~     cardiac deaths. Several risk factors associated with sudden death and not with myocardial~     infarction have been identified in population-based studies. However, the relationship~     between the occurrence of a coronary artery occlusion and the onset of arrhythmia is unclear.~     In particular, coronary artery occlusion can be rapidly followed by chest pain, which acts as~     a signal and allows identification of patients for emergency reperfusion. However, in some~     cases, the coronary artery occlusion is followed by a sudden onset of arrhythmia and sudden~     death. Recent data suggest that acute coronary occlusion is caused by plaque erosion or~     rupture and is followed by an intense local inflammation and rapid thrombus formation. Our~     hypothesis is that the speed of thrombus formation and coronary occlusion determines the~     clinical symptoms. Slow and progressive thrombus formation is likely to induce myocardial~     pre-conditioning thereby reducing the occurrence of ventricular arrhythmia. In contrast,~     rapid thrombus formation followed by acute coronary artery occlusion and ischemia is more~     likely to trigger fatal ventricular arrhythmia. During angioplasty procedures, coronary~     artery thrombus are aspirated, providing the opportunity for pathological studies. The aim of~     the TIDE study (Thrombus and Inflammation in Sudden Death) is therefore to compare the~     composition and age of thrombus collected at the site of coronary occlusion in patients with~     sudden death due to acute coronary artery occlusion and patients with an acute myocardial~     infarction without ventricular arrhythmia. The following hypothesis will be tested : fresh~     thrombus is more frequent in patients with sudden cardiac death versus patients with acute~     myocardial infarction without ventricular arrhythmia.~   "
214799|NCT00748098|"~     The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release~     tablets in the treatment of patients with Restless Legs Syndrome and associated sleep~     disturbance.~   "
214800|NCT00748085|"~     The purpose of this study is to evaluate the safety, and tissue effect of the CryoSpray~     Ablation(TM) System (CryoSpray Ablation(TM), CSA or cryospray therapy) at multiple~     centers to treat malignant airway disease in the lung using liquid nitrogen sprayed through a~     catheter via flexible fiber optic bronchoscopy (FFB)~   "
214801|NCT00748072|"~     The investigators evaluated the effect of pre-biopsy treatment with 1-deamino-8-D-arginine~     (DDAVP) on the incidence of post-biopsy bleeding complications. This is a IV phase single~     centre, double blind, randomized controlled study in patients, with acute and chronic~     nephropathy, undergoing ultrasound-guided percutaneous renal biopsy.~   "
214802|NCT00748059|"~     The purpose of this study is to determine the cause of low blood pressure in selective~     patients who have problems with their involuntary (autonomic) nervous system. These patients~     frequently have had symptoms throughout their life, and their disorder might have a genetic~     basis. The biochemical, physiological and pharmacological procedures in this study should~     help us define the problem and perhaps lead to more effective treatment.~   "
214803|NCT00748046|"~     The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry~     and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).~   "
214804|NCT00748020|"~     Study on two different irradiation schemes in UVB phototherapy for psoriasis. Previous~     studies demonstrated a similar clinical effect in erythematogenic and suberythematogenic~     irradiation, with less complications in suberythematogenic irradiation. Most of these studies~     used both irradiation schemes within the same patient. UVB has a systemic effect on the body.~     Our hypothesis is that previous conclusions are incorrect and that the erythematogenic scheme~     will result in earlier clearance of the psoriasis.~   "
214805|NCT00748007|"~     This study is to understand the efficacy on language and cognitive function in Down syndrome~     patients who take Rivastigmine.~   "
214806|NCT00747994|"~     Paget's disease of bone is a frequent bone disorder which usually starts after the age of 40~     and which is characterized by bone pain and deformities. Although often without any symptoms,~     this disease may have severe complications such as fissures, fractures, neurological~     compression, or deafness. In some cases, it is a genetic disorder transmitted with a dominant~     autosomal pattern of inheritance: one of the two parents carrying the disease transmits it to~     his offspring with a risk of 50% for each child. Since 2002, the first gene involved in~     Paget's disease of bone is known and 14 mutations of this gene have been published. A study~     confirmed that the presence of those mutations was associated with younger age of onset and~     more extensive disease. Thus, the knowledge of those genetic factors in the relatives of an~     affected individual allows the screening of the patients with a higher risk for~     complications, who may benefit from a medical follow up and earlier treatment, in order to~     avoid complications. Indeed, Paget's disease of bone may be treated efficiently by~     bisphosphonates.~      This project aims at identifying and collecting over one year, 15 affected individuals~     affected by Paget's disease of bone and the relatives up to the second degree of relativeness~     (a total of 100 individuals is expected). The blood samples may be analysed in order to~     search for mutations of the previously known gene and/or to search for new mutations on new~     genes.~   "
214807|NCT00747981|"~     To access CT Scan as a diagnostic tool for foreign bodies aspiration.~   "
214808|NCT00747968|"~     30 type 2 diabetic patients will be PET-scanned twice ( half of the patients heart-PET, half~     of the patients CNS-PET) in random order with infusions of placebo or GLP-1-analogue during~     hyperglycemic clamp to uncover the metabolic effects of GLP-1-analogues in perspectives of~     intervention of macrovascular late diabetic pathology such as stroke and AMI. Earlier studies~     have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in~     blood sugar when infusing native GLP-1.~   "
214818|NCT00747838|"~     Minimally invasive surgical treatment of atrial fibrillation is safe and effective at~     controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve~     the understanding of the efficacy of surgical ablation intervention in the treatment of~     atrial fibrillation.~   "
214819|NCT00747825|"~     This is an open-label, single dose study for patients 18 years of age or older with confirmed~     metastatic melanoma. Up to 12 patients will be enrolled and all will receive an injection of~     approximately 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145 administered via IV injection.~     The study will consist of a single dosing day followed by a 7-day assessment period and~     21-day follow-up period. The total duration of the study from screening to final follow-up~     visit is approximately 60 days.~   "
214809|NCT00747955|"~     This study will evaluate new assessment tools and equipment and new ways of using existing~     tools and equipment in the NIH Clinical Center s Rehabilitation Medicine Department in order~     to maximize patients function. The Department assesses and treats NIH patients with chronic~     pain, problems in walking or getting around, activities of daily living, performing tasks~     needed for jobs or hobbies, communicating and chewing and swallowing.~      Children and adults of all ages with disabilities and healthy normal volunteers may be~     eligible for this study.~      The following kinds of assessments are evaluated in this study:~      Assessments of Impairments~      Impairments are problems such as loss of movement, weakness or loss of sensation. Assessments~     may include measurements of range of motion, strength, sensation, pain, joint stability or~     mobility, joint angles, limb and girth, gait, exercise tolerance, stamina, or ultrasound~     imaging of muscle and swallowing function.~      Assessments of Function and Performance~      Functional and performance assessments look at how well subjects perform actions, such as~     walking or getting around, dressing, or preparing meals. They may include evaluations of~     activities of daily living, leisure activities, fatigue, vocational activity, school~     activity, coping skills, and quality of life. The assessments may be done by questionnaires~     or interviews and by watching subjects perform the activities.~      Assessments of Treatment Techniques~      Treatment techniques are assessed by evaluating methods and equipment used to treat patients~     with impairments or problems with function. They may evaluate, for example, the use of heat,~     cold, strengthening exercises, fitness exercises, TENS units, splinting and orthotics, or~     shoe modifications.~   "
214810|NCT00747942|"~     The purpose of this study is to improve and analyze the level of physical activity in~     immigrant women from the Middle East and Latin America living in Sweden. The investigators~     will also investigate if glucose, insulin, and lipid metabolism; stress-related hormone~     production; and subclinical inflammatory activity are affected by the intervention. The~     follow-up period is 2 years.~   "
214811|NCT00747929|"~     1. To evaluate the effect of S-2367 on body weight when administered following a 6-week~          placebo lead-in period and then a 54-week 800 kilocalorie deficit reduced calorie diet~          compared to placebo in healthy obese male and female subjects~        2. To evaluate the safety and tolerability of S-2367 during 54 weeks of drug exposure~        3. To evaluate the steady-state/trough pharmacokinetics of S-2367~   "
214812|NCT00747916|"~     The purpose of this study is to evaluate the safety, efficacy, and side effects of the~     CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal~     pleural surface.~   "
214813|NCT00747903|"~     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a~     certain kind of light. When the drug is active, tumor cells are killed. This may be an~     effective treatment against skin cancer.~      PURPOSE: This phase II trial is studying the side effects of photodynamic therapy using~     aminolevulinic acid and to see how well it works in treating patients with skin cancer.~   "
214814|NCT00747890|"~     Obstructive sleep apnea (OSA) is one of the most common sleep disorder. There are numerous~     conditions that are related to OSA, such as diabetes, cardiovascular diseases, and metabolic~     syndrome. If the patient with OSA have large tonsils, soft and largened uvula or flacid soft~     palate, one might benefit from operative treatment of OSA. The aim of our study is to find~     out whether an operative treatment is effective in mild OSA patients with carefully assessed~     anatomical predispositions. Our ultimate goal is to evaluate the effects of operative~     treatment in mild OSA itself and in the diseases related to OSA. We measure the~     cardiovasculary functions, symptoms, postoperative recovery, antropometry, laboratory tests,~     the quality of life, the quality of sleep and the inflammatory system in sleep apnea before~     and after the surgery.~   "
214815|NCT00747877|"~     RATIONALE: Giving chemotherapy and bortezomib before a peripheral stem cell transplant stops~     the growth of cancer cells by stopping them from dividing or killing them. Giving~     colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells~     move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is~     then given to prepare the bone marrow for the stem cell transplant. The stem cells are then~     returned to the patient to replace the blood-forming cells that were destroyed by the~     chemotherapy and bortezomib. It is not yet known whether high-dose melphalan given together~     with a second stem cell transplant is more effective than low-dose cyclophosphamide in~     treating patients with relapsed multiple myeloma.~      PURPOSE: This randomized phase III trial is studying giving high-dose melphalan together with~     a second stem cell transplant to see how well it works compared with low-dose~     cyclophosphamide in treating patients with relapsed multiple myeloma after chemotherapy.~   "
214816|NCT00747864|"~     S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS)~     and is increased in CSF and blood after CNS injury. There are two objectives to this study.~     1) To complement our previous study, is urine S100B concentration correlated with gestational~     age in infants born at > 28 weeks gestation during the first week of life? 2) Is the urine~     concentration of S100B affected by intracranial pathology in this gestational age range?~     Elevation of urine concentration of S100B may be an indicator that the infant will develop~     serious intracranial pathology and may allow for early initiation of treatment to potentially~     decrease morbidity.~   "
214817|NCT00747851|"~     This is a prospective in vitro cell biology study of polymorphonuclear leukocyte (PMN)~     protein synthesis in response to PAF. PMNs from cord blood of premature human infants at risk~     for NEC (birth weight between 501 - 1500 grams) and PMNs from cord blood of healthy term~     infants will be isolated and stimulated with PAF, a biologically active phospholipid~     implicated in the pathogenesis of NEC. NEC, a disease of prematurity with an incidence of~     10.1% of infants born weighing between 501 - 1500 grams, is associated with significant~     morbidity and mortality. We will compare the protein synthesis of inflammatory modulators,~     including Interleukin 6 Receptor alpha (IL-6R alpha) and Retinoic Acid Receptor alpha (RAR~     alpha) proteins to protein synthesis responses already observed in PMNs isolated from healthy~     adults. Furthermore, we will characterize the expression and activity of the mammalian target~     of rapamycin (mTOR) translational protein synthesis control pathway in PMNs isolated from~     preterm and term infants and compare those results with previous observations in PMNs~     isolated from adults. This pathway is known to regulate IL-6R alpha and RAR alpha protein~     expression in PMNs isolated from adults. We will also follow those premature infants at risk~     for NEC clinically to determine which infants develop NEC and what risk factors may be~     associated with NEC in this population.~   "
214820|NCT00747812|"~     The purpose of this study is to evaluate the safety and effectiveness of an implantable~     device to treat migraine. There are a significant number of patients who have drug refractory~     migraine and alternative therapies are needed.~   "
214821|NCT00747799|"~     This study is a phase II clinical study. Recurrence after radiotherapy patients who are~     failure of radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC) were~     treated by cisplatin and 5-fluorouracil with Sorafenib as first-line treatment. The objective~     response(complete response (CR) + partial response (PR)), Disease Control Rate , safety~     profile, tolerability will be evaluated according to World Health Organization (WHO)~     criteria.~   "
214822|NCT00747786|"~     The purpose of this study, is to assess the safety and local tolerability of the long-term~     use of Somatuline Autogel when administered by patients or their partners (Home Injection~     Group) and the safety and local tolerability in patients receiving their injection from a~     healthcare professional (HCP) (Reference Group).~   "
214823|NCT00747773|"~     The purpose of this study is to evaluate the feasibility and general safety in the human~     airway as well as assess the safety and depth and area of treatment using liquid nitrogen~     sprayed through a catheter via flexible fiber optic bronchoscopy (FFB) using surgical~     resection specimens from patients undergoing lobectomy.~   "
214824|NCT00747760|"~     Resistance to thyrotropin (RTSH) is a condition of impaired responsiveness of the thyroid~     gland to TSH, characterized by elevated TSH, low or normal thyroid hormone levels, and~     hypoplastic or normal-sized thyroid gland.~      The aim of the present study was to evaluate the clinical course over time,the~     genotype-phenotype association and the frequency of two different TSH-receptor (TSHR)~     mutations in a highly consanguineous population of the town of Um-El-Fahem.~   "
214825|NCT00747747|"~     The goal of the study is to demonstrate that SINUclean DM® spray, added to the standard~     (amoxicillin/clavulanate) therapy of the acute episode of sinusitis (acute, subacute or~     chronic), is safe ad capable to determine the resolution of the symptoms in a shorter time in~     comparison with the standard therapy without co-adjuvant, or with simple saline lavage.~   "
214826|NCT00747734|"~     This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A~     administered by IV infusion every 3 weeks in patients with locally advanced or metastatic~     solid tumors for whom standard therapy either does not exist or has proven to be ineffective~     or intolerable. This study will be conducted at up to three study centers in the United~     States.~   "
214827|NCT00747721|"~     The study will examine dexmedetomidine levels in the blood of critically ill intensive care~     patients to understand how it is broken down by the body.~   "
214828|NCT00747708|"~     The purpose of this study is to determine whether adult bone marrow derived stem/progenitor~     cells improve cardiac function and symptoms in patients with heart failure and to establish~     the optimal method of delivery of these cells.~      Study hypotheses:~        -  Administration of G-CSF to patients with heart failure secondary to ischaemic heart~          disease will lead to an increase in circulating progenitor cells as measured by~          peripheral CD34+ positive cell counts~        -  Cardiac function and symptoms will improve in patients in whom the peripheral CD34+~          counts increase in response to G-CSF administration~        -  Direct coronary injection of autologous bone marrow derived stem cells will confer an~          additional improvement in cardiac function and symptoms above that derived from G-CSF~          infusion alone~        -  Direct intramyocardial injection of autologous bone marrow derived stem cells will lead~          to an improvement in cardiac function and symptoms above that derived from G-CSF~          infusion alone~   "
214829|NCT00747695|"~     The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics and safety of~     rabeprazole after single and multiple daily administration in children between the ages of 1~     and 11 years, inclusive, with GERD.~   "
214830|NCT00747682|"~     The specific aim of the research proposal in preterm infants with IVH and PHH who require~     placement of an Omaya reservoir or a shunt is to determine if decreasing ventricular volume~     improves, middle cerebral artery flow, cerebral oxygenation, and cortical neuronal electrical~     activity. To accomplish this aim, we will simultaneously perform the following evaluations~     prior to shunt placement or prior to and after routine CSF aspiration from reservoir in:~        1. middle cerebral artery velocity time integral and resistive index using Doppler~          ultrasonography~        2. cerebral oxygenation using near infrared spectroscopy (NIRS)~        3. background neuronal electrical activity using an EEG. In addition, we will measure~          serial CSF concentration of neuroproteins, S100B, GFAP, NSE, TGF-ß, and IL-6, as~          evidence of ongoing neuronal damage and correlate the concentration with cerebral~          perfusion and activity as measured above.~   "
214831|NCT00747669|"~     This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute~     application of Synera.~   "
214832|NCT00747656|"~     Despite remarkable gains in treatment over the last decade short-term mortality for those who~     survive to hospital with AT-elevation acute myocardial infarction (STEMI) remains high~     (5%-10%). Different studies have pointed out that reperfusion (intravenous fibrinolysis or~     percutaneous coronary interventions (PCI) and its timing are critical in decreasing STEMI~     patients' mortality. Studies of prehospital 12 lead electrocardiograms (12 lead PHECG) with~     advance emergency department (ED) notification suggest that there is a time to treatment~     advantage with this intervention. The use of 12 lead PHECG is not currently universal and~     part of standard treatment throughout the province. The purpose of the study is to follow~     STEMI study subjects during standard treatments and to compare the outcomes of subjects that~     received 12 lead PHECG with advanced ED notification in mixed rural/urban areas with outcomes~     of subjects treated in areas with only 3 lead PHECG monitoring and indirect ED notification.~     The investigators hypothesize that there will be a survival benefit for study subjects with~     12 lead PHECG and advance ED notification in rural and urban environments through a reduction~     in door-to-reperfusion time and that 12 lead PHECG will be a cost-saving technology for the~     province of Ontario.~   "
214833|NCT00747643|"~     The purpose of this study was to find out how varenicline works to help people quit smoking.~     Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved~     medication that has been shown to help people quit smoking. This study was trying to evaluate~     whether varenicline would change the response to smoking and the desire for cigarettes when~     compared to an inactive placebo control. This was not a quit smoking treatment study, and~     participants were not asked or required to stop smoking while in this study.~   "
214835|NCT00747617|"~     The mechanism for increased androgen production in women with polycystic ovary syndrome~     (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by~     increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators~     hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen~     synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal~     women. To test this hypothesis, the investigators propose to conduct a dose-response study in~     which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH~     surrogate, will be assessed in PCOS and normal women.~   "
214836|NCT00747604|"~     This project is a retrospective (beginning January 2006) and prospective patient registry~     program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating~     health care practitioners, the patient registry program is an observational study monitoring~     the long-term safety of patients treated with Increlex® (mecasermin [rDNA origin] injection).~     The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the~     safety and efficacy of Increlex replacement therapy in children with growth failure.~   "
214837|NCT00747591|"~     S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS)~     and is increased in CSF and blood after CNS injury. There are two objectives to this study.~     Is urine S100B concentration correlated with the serum concentration of S100B in infants born~     at 29-36 weeks gestation. The presence and severity of intracranial pathology on S100B~     concentration will be investigated. Further analysis will demonstrate if birth weight, daily~     fluid intake, urine output, and urine creatinine influence this relationship.~   "
214838|NCT00747578|"~     Ankylosing spondylitis (AS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE)~     are the most common rheumatic diseases dealt with rheumatologists in Taiwan. In previous~     studies, the 3 diseases all have broad impacts on health-related quality of life of patients~     and drive enormous economic burden on patients and society. The objective of this study is to~     compare health-related quality of life and disease-related costs between patients with the 3~     different diseases.~      We will invite at least 100 patients with AS, RA or SLE respectively who are regularly~     followed in the outpatient clinic of the Division of Rheumatology at Taichung Veterans~     General Hospital (VGHTC) to participate in the study. Patients who have cognitive impairment,~     who are older than 65 years old or younger than 18 years old, who have overlapping syndrome~     of any 2 of the 3 rheumatic diseases (eg. RA overlapping with SLE) or who have visited~     rheumatologists in the outpatient clinics at VGHTC for less than 4 times in 2008 will be~     excluded. Patients who agree to take part will attend a comprehensive clinical examination in~     the outpatient department. Patients will complete a questionaire including demographic and~     disease characteristics, and health-related quality of life at the time of survey. The~     questionaires about disease-related costs will be completed once per quarter throughout 2009.~     The four questionaires about costs will be given at the time of initial survey and will be~     returned by returned by mail or in the following outpatient clinics visits every 3 months in~     2009.~      The result of this study will help patients to realize their own health-related quality of~     life and disease-related costs and help government in Taiwan to realize the socioeconomic~     burden of the 3 common rheumatic diseases and to allocate health care resources more properly~     in the future.~   "
214839|NCT00747565|"~     To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from~     two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol~     DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol~     DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal~     control. The original study was conducted in 2004-2006; the expansion study was conducted in~     2007-2008. Results from both studies were analyzed together for FDA approval.~   "
214840|NCT00747552|"~     The observational study is designed to determine the feasibility of performing~     Intra-Abdominal Pressure (IAP) via bladder pressure measurements and of tracking IAP in~     neonates who require bladder catheterization. Correlation of IAP measurements with clinical~     status of the neonatal abdomen will help determine threshold values for Intra-Abdominal~     Hypertension (IAH) in the neonate.~   "
214841|NCT00747539|"~     This study will evaluate the impact of standard hepatitis C virus treatment on brain deficits~     in people who are infected with both HIV and the hepatitis C virus.~   "
214842|NCT00747526|"~     The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the~     body, how it is distributed within the body and removed from the body over time),~     pharmacodynamics (how the study medication affects the body) and safety of rabeprazole after~     single and multiple daily administration in infants between the ages of 1 and 11 months,~     inclusive, with Gastroesophageal Reflux Disease (GERD).~   "
214843|NCT00747513|"~     In an attempt to challenge the increasing prevalence of childhood obesity, many programs have~     been executed in order to improve childrens' lifestyle. Programs involved either school,~     family or environmental measures. In most, success was only limited.~      The purpose of this trial is to examine the ability of a low-cost multi-component program to~     improve behavioral, diet and activity habits in both school, family and afternoon settings.~     Ths ultimate goal is to construct and assess a lifestyle modification program that can be~     implemented in schools and kindergartens on a national level.~      Participants will be ~2,500 children aged 5-12 from 22 kindergartens and elementary schools,~     divided into control and intervention centers.~      Teachers and students will be provided with materials in order to perform activities on~     healthy food and drink choices and habits during the school day. Schools will offer increased~     physical activity opportunities to children, as will afternoon community centers. Children~     will be given personal exercise items. Parents will be offered lectures on topics of diet and~     activity. Diet and activity habits will be assessed by a questionnaire, and height, weight~     and body fat percentage will be measured before and after the program.~   "
214844|NCT00747500|"~     The purpose of this study, is to assess the safety and local tolerability of the long-term~     use of Somatuline Autogel when administered by patients or their partners (Home Injection~     Group) and the safety and local tolerability in patients receiving their injection from a~     healthcare professional (HCP) (Reference Group).~   "
214845|NCT00747487|"~     This study is meant to assess the effectiveness of idebenone on visual function measures in~     patients with Leber's Hereditary Optic Neuropathy over a 6 months period.~   "
214846|NCT00747474|"~     The purpose of this study is to find a safe and tolerable dose of Lipotecan® when~     administered to patients with advanced solid tumors.~   "
214847|NCT00747461|"~     The purpose of this study is to evaluate the safety, effectiveness, and side effects of the~     CryoSpray AblationTM System (CryoSpray AblationTM, CSA or cryospray therapy) to treat~     benign airway disease in the lung using liquid nitrogen sprayed through a catheter via~     flexible fiber optic bronchoscopy (FFB)~   "
214848|NCT00747448|"~     The purpose of this study is to create a patient registry to collect and analyze post-510K~     approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.~   "
214849|NCT00747435|"~     The purpose of this investigation is to demonstrate the safety and effectiveness of the~     MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear~     implant with an external electric-acoustic processor designed to provide benefit in speech~     perception and sound quality to individuals with a sensorineural hearing loss with minimal~     changes in residual hearing. The acoustic component of the processor will aid residual~     acoustic hearing in low frequency ranges, while the cochlear implant and electric component~     of the processor will be used to electrically stimulate the auditory nerve across a wide~     range of frequencies necessary for speech perception.~   "
214850|NCT00747422|"~     The purpose of this study is to look at how safe and effective the Ulthera ultrasound system~     is at reducing the appearance of wrinkles when used with subjects who have wrinkles around~     the eyes.~   "
214851|NCT00747409|"~     Compared to human insulins analogue insulins offer the option of optimizing metabolism also~     in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose~     levels more effectively than human regular insulin. However, it is not known whether therapy~     with analogue insulins can also improve the subclinically impaired myocardial function in~     type 2 diabetes. This prospective, randomized, open long term study compared the effects of a~     basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control~     and systolic and diastolic myocardial function, testing the hypothesis that optimized~     postprandial glucose control improves cardiac function and cardiovascular risk.~   "
214852|NCT00747396|"~     The purpose of this study is to determine the long term effects of early intervention~     (placement into foster care) on physical, cognitive, social and brain development and~     psychiatric symptomatology in previously institutionalized children.~   "
214853|NCT00747383|"~     The study is aimed at Type 2 Diabetics who are taking Metformin, but whose Diabetes remains~     poorly controlled. There are two additional medications already in use, Glimepiride and~     Sitagliptin will be compared to assess levels of improvement in Diabetes control.~   "
214854|NCT00747370|"~     The purpose of this study was to test the suitability of dynamic magnetic resonance imaging~     for the pelvic floor floor, bladder neck and urethra in healthy volunteers, in stress~     incontinent patient and in women with genital prolapse.~   "
214855|NCT00747357|"~     The INDICOR study is a controlled, prospective, multicenter, randomized, two arm phase-II~     real world study assessing the acute, 6 months, and 12 months and 3 year outcome of~     cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon~     dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent~     Please) followed by cobalt-chromium stent (Coroflex Blue) deployment for the treatment of~     de-novo and restenotic lesions in native coronary arteries. The study will be conducted in~     India.~   "
214856|NCT00747344|"~     The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the~     treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.~   "
214857|NCT00747331|"~     Cardiopulmonary bypass (CPB) for cardiac operations may be accompanied by different patterns~     of visceral underperfusion. This could result in clinical patterns of lactic acidosis but in~     the most severe cases there is the risk for mesenteric infarction (0.2% of the cases). Renal~     function as well may be impaired due to a low oxygen delivery, and acute renal failure occurs~     in 1-2% of cases.~      Fenoldopam mesilate is a selective splanchnic vasodilator when used at a dose < 0.1~     mcg/kg/min.~      The experimental hypothesis of this randomized, controlled trial (RCT) is that the use of~     fenoldopam may determine a better visceral perfusion during CPB.~   "
214858|NCT00747318|"~     The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA~     pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have~     completed the study SKY2028-3-005.~   "
214859|NCT00747305|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. Giving it after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This clinical trial is studying how well sunitinib works when given before and after~     surgery in treating patients with metastatic kidney cancer that can be removed by surgery.~   "
214860|NCT00747292|"~     The aim is to ascertain which method out of epidural, spinal or patient controlled analgesia~     (PCA) is the most appropriate in fluid optimised patients after laparoscopic colorectal~     surgery in terms of pain control, length of hospital stay and time for gut recovery. The~     second aim is to assess the physiological changes that occur when the patient is placed in~     steep trendelenberg position together with the creation of the pneumoperitoneum.~   "
214861|NCT00747279|"~     The purpose of this prospective randomized controlled trial was to compare intensive insulin~     therapy with a carbohydrate restrictive strategy in patients with acute ischemic stroke~     evaluating the outcome through the Glasgow Outcome Scale Extended, hospital mortality and~     NIHSS during the ICU stay.~   "
214862|NCT00747253|"~     The main purpose of this study is to evaluate the safety and performance of the AutoLITT~     system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).~   "
214863|NCT00747240|"~     This is a prospective observational study to determine whether there is an association~     between the presence of platelet-activating factor acetylhydrolase (PAF-AH) gene~     polymorphisms and the development of chronic lung disease in very low birth wight infants.~     Infants < 1500 grams at birth who require mechanical ventilation will be enrolled in the~     first 5 days of life after obtaining informed consent. A total of 1 ml of blood will be drawn~     and utilized for isolation of DNA for genotyping and for measurement of PAF-AH activity in~     serum.~   "
214864|NCT00747227|"~     The purpose of this study is to evaluate the safety and effectiveness of a new~     investigational modified light transmission monofocal intraocular lens compared to a~     conventional intraocular lens (IOL).~   "
214865|NCT00747214|"~     This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus~     DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and~     Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was~     planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).~   "
214866|NCT00747201|"~     This study will determine if a version of the bipolar care model adapted for a nonresearch~     audience can improve patient health and correct use of the model in community-based mental~     health care sites.~   "
214869|NCT00747162|"~     The investigators plan to enroll 500 consecutive Subjects at a major trauma center for this~     study. For each patient, the body mass index (BMI), age, sex, diastolic pressure and mean~     arterial pressure (MAP) at time of measurements. Additional information including diseases~     such as diabetes and vascular disorders will be recorded. Social demographics including~     alcohol and tobacco use will be recorded. This is important as alcohol and tobacco use could~     also contribute to cardiovascular diseases. The skin pigmentation of each subject will be~     recorded. Two different methods will be used for this measurement. Each patient will be~     graded on a six point scale as described by Young (Young, 1997). Additionally, each subject~     will have their skin measured using a reflectance colorimeter. The colorimeter,~     DermaSpectrometer II (cyberDerm, Broomall, PA) uses visible light to measure the amount of~     light reflected off the skin. By measuring the light reflectance, the skin pigmentation can~     be measure (Clarys, 2000). Muscle oxygenation will be measured using a continuous dual~     wavelength near infrared spectrometer. Using the different absorption characteristics of~     deoxyhemoglobin and oxyhemoglobin, the concentration of oxyhemoglobin in the muscle at an~     approximate depth of 2.5 cm is determined. The INVOS cerebral oximeter (Somanetics, Troy, MI)~     will be used for all measurements.~   "
214870|NCT00747149|"~     This study will assess if customizing the start dose of rosuvastatin appropriate for the~     degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with~     either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic~     patients previously treated with another statin and not at LDL-C targets.~   "
214871|NCT00747136|"~     The purpose of this study is to demonstrate the clinical utility of the WavSTAT Optical~     Biopsy System as an adjunctive tool to improve the endoscopist's clinical sensitivity to~     identify dysplasia or cancer in the esophagus.~   "
214872|NCT00747123|"~     Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and~     efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.~   "
214873|NCT00747110|"~     The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9~     mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative~     colitis.~   "
214874|NCT00747097|"~     The purpose of this phase II study is to assess the efficacy of combined chemotherapy using~     gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.~   "
214875|NCT00747084|"~     This research study compares two methods of performing colonoscopy without sedation. The~     standard method is to insert the colonoscope without adding any water to the colon, and when~     colonic spasms occur during the examination, waiting for the spasms to subside before~     continuing with the insertion of the colonoscope. The study method involves putting 200 ml (7~     oz) of warm water through the colonoscope into the colon at the beginning of the examination,~     and when colonic spasms occur during the examination, putting 30 ml (1 oz) of warm water into~     the spastic area(s) to relax the colonic spasms.~   "
214876|NCT00747071|"~     This clinical study is designed to evaluate the safety and efficacy of oral administration of~     the food additive colostrum derived antibodies to Clostridium difficile for prevention of~     Clostridium difficile associated disease (CDAD).~   "
214877|NCT00747058|"~     The purpose of this study is to determine the safety and tolerability of PF-03864086 in~     healthy male human volunteers. Determine the pharmacokinetics (calculations of the rate of~     elimination of PF-03864086 from the body once the compound is ingested).~   "
214878|NCT00747045|"~     Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by unresolved thromboemboli~     in the pulmonary arteries, which lead to pulmonary hypertension and, left untreated, right~     heart failure. This disease can be potentially cured by performing a pulmonary~     thromboendarterectomy (PTE) to remove the blood clots. The surgery is not without risk and~     the most worrisome complication is the development of a form of acute lung injury called~     reperfusion lung injury, which occurs in about 40 percent of patients.~      The landmark publication of the ARDSNET study demonstrated that a low tidal volume strategy~     of mechanical ventilation, decreased morbidity and mortality in patients who had acute~     respiratory distress syndrome (ARDS). Since then there have been some studies examining the~     role of a low tidal volume strategy in all patients who are mechanically ventilated. Some~     studies have demonstrated a decreased incidence of acute lung injury while others have failed~     to do the same. In patients at high risk for developing acute lung injury, such as patients~     undergoing PTE, there may be a benefit to using low tidal volumes to reduce the incidence of~     reperfusion lung injury.~      To assess the efficacy of a low tidal volume ventilation strategy in patients undergoing PTE,~     134 patients will be randomized at the time of surgery to either low tidal volumes (6ml/kg of~     ideal body weight), or standard tidal volumes (10ml/kg of ideal body weight). Patients will~     be followed clinically to assess for the development of reperfusion lung injury. This will be~     defined as the development of hypoxemia (PaO2/FiO2 ratio less than 300) and chest infiltrates~     in the area of reperfused lung with no other identifiable etiology within the first 72 hours~     of surgery. Patients will also be assessed for other factors known to contribute to acute~     lung injury including: plateau pressures, peak inspiratory pressures, fluid balance, and~     number of transfusions received. Secondary endpoints of the study will be: time to successful~     spontaneous breathing trial, ventilator free days, ICU free days, hospital free days, and~     mortality.~   "
214879|NCT00747032|"~     The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of~     Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study~     product will be applied to the affected skin, excluding the face, once daily, at~     approximately the same time daily.~   "
214880|NCT00747019|"~     The purpose of this study is to compare two exercise programs to determine how well they help~     older adults make exercise a regular habit after 9 months.~   "
214881|NCT00747006|"~     The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder~     is established for either a type 1 or 2 patient, based on a average diabetic meal, the~     patient's favorable dose can be used safely, regardless of change in meal carbohydrate~     content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150%~     or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose~     for their normal meal.~   "
214920|NCT00746499|"~     Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and~     cervicovaginal samples will be taken most mornings around the AM dose. Two visits, ~14 hrs in~     length will be required on Day 1 and 7. The purpose of this study is to measure how much~     raltegravir is found in the genital tract after taking it orally.~   "
214921|NCT00746486|"~     The study is aimed to compare the efficacy and tolerability of a combination therapy with~     ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs.~     ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. Depending on~     ALT values 6 mg/d budesonide are allowed. The study population will be patients with PBC at~     risk for disease progression. It is assumed that the combination therapy will result in a~     decrease of treatment failures after 3 years of treatment.~   "
214882|NCT00746993|"~     In the United States, highly effective methods of birth control are often not used.~     Healthcare providers use birth control counseling and patient education as ways to increase~     the usage of birth control. However, little evidence exists to show that patient education~     and birth control counseling changes birth control use.~      We want to evaluate the effectiveness of using a uniform set of birth control information to~     provide birth control education to women having an early pregnancy termination. The~     counselors will allow the clients to both read as well as hear the information. We propose to~     evaluate whether this counseling will lead to 1) more women choosing highly effective~     nonpermanent birth control methods and 2) more women continuing to use these methods for a~     longer time.~      Women in the study will complete a questionaire about their health. Half of them will have~     the structured counseling and half will have the routine counseling currently offered to~     women as a part of their routine care. We will contact all study participants with a~     telephone call three months and six months later to have a 10 minute conversation about what~     birth control they are using.~   "
214883|NCT00746980|"~     Determine the effect that treatment with efalizumab has on scalp hair re-growth in younger~     adults affected by severe variants of alopecia areata, including alopecia totalis, alopecia~     universalis, and severe ophiasis variants.~   "
214884|NCT00746967|"~     The purpose of this study is to evaluate the safety and toleration of oral sildenafil~     administered as required by women with Female Sexual Arousal Disorder (FSAD) who successfully~     complete one of the following Pfizer-sponsored, 12-week, double-blinded clinical trials:~     A1481082 or A1481123. Addition of this 52-week open-label extension will increase the total~     duration of sildenafil exposure to 64 weeks. Sustained efficacy will also be evaluated after~     3 and 6 months of open-label therapy.~   "
214885|NCT00746954|"~     The purpose of this study is to determine whether buspirone compared to acetazolamide and to~     placebo will reduce the number and/or severity of breathing pauses during sleep that occur in~     some patients with Heart Failure.~   "
214886|NCT00746941|"~     The primary objective of the study was to explore whether mefloquine can delay or stop~     progression of progressive multifocal leukoencephalopathy (PML) as measured by JC virus~     (human polyomavirus or JCV) deoxyribonucleic acid (DNA) levels in cerebrospinal fluid (CSF).~     The secondary objective of the study was to explore whether mefloquine can delay or stop~     progression of PML based on neurological deterioration, magnetic resonance imaging (MRI)~     measures of brain lesion evolution or the formation of new lesions, and mortality.~   "
214887|NCT00746928|"~     The study is a prospective field evaluation to assess the effects of the chronic Intermittent~     Hypoxia exposure in 12 healthy humans.~      Precisely, the study was designed to :~      Set up a new model of Chronic Intermittent Hypoxia (CIH) applied to healthy human. This CIH~     is mimicking the CIH undergone by patients suffering from Sleep Apnea Syndrome.~      Evaluate the cardiovascular effect of CIH. Neuronal and humoral sympathetic control, blood~     pressure control, vascular resistance.~      Evaluate the Sleep quality, the ventilation under exposure and the long terms effect on~     ventilation control of CIH (central and peripheral chemoreflex).~      Investigates the biological aspects of CIH exposure.~   "
214888|NCT00746915|"~     The objectives of this study are to evaluate the safety and initial efficacy of the epidural~     injection procedure when combined with real-time multi-frequency bio-impedance measurements~     that collect data on the electrical bioimpedance characteristics of living human tissue on~     the path of the epidural needle.~   "
214889|NCT00746902|"~     The purpose of the study is to investigate the links between blood pressure (BP), overweight~     or obesity, and sleep apnea syndrome (SAS), by studying a large cohort of subjects suffering~     from refractory hypertension.~      Primary objective~        -  To compare plasmatic leptin levels in patients suffering from refractory hypertension~          depending on whether or not they experience SAS.~      Secondary objectives~        -  To ascertain what determines the difference in plasmatic leptin concentrations in~          patients suffering from refractory hypertension depending on whether or not they~          experience SAS.~        -  To characterise BP readings (from clinical and ambulatory (ABPM) measurements) in~          patients suffering from refractory hypertension depending on whether or not they~          experience SAS.~        -  To characterise metabolic parameters (lipids, glycaemia, adiponectin) and sympathetic~          nervous system effectors (adrenaline, noradrenaline and metanephrines) in patients~          suffering from refractory hypertension depending on whether or not they experience SAS.~        -  To characterise BP readings, metabolic parameters and sympathetic nervous system~          effectors in patients suffering from refractory hypertension according to the severity~          of the SAS (in those who experience this problem).~        -  To study, in patients with both SAS and refractory hypertension, the impact of nasal~          continuous positive airway pressure (CPAP) treatment on BP readings, metabolic~          parameters and sympathetic nervous system effectors, by comparing those who are~          compliant with the CPAP regimen with those who are non-compliant.~   "
214890|NCT00746889|"~     A study using characteristics on ultrasound to predict response to intraarticular steroid~     injections in patients with knee osteoarthritis. The hypothesis is that patients with~     inflammation on ultrasound will have a better response to corticosteroid injections compared~     to patients without inflammation.~   "
214891|NCT00746876|"~     Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures).~     Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses~     has a one-piece design where the hip movement occurs between the prosthesis and the~     acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the~     two components of the prosthesis. Both treatments are clinically proven and common around the~     world. No clinical trial has proven benefits of one or the other prosthesis design. The~     investigators want to measure the differences in acetabular wear using these two prostheses,~     using radiostereometric measurements.~   "
214892|NCT00746863|"~     There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject~     local pain medical into the retropubic space before placing the sling, others do not. This~     study is to determine if injection of local pain medication into the retropubic space before~     placing a mid-urethral sling for urinary stress incontinence results in lower postoperative~     pain scores, lower use of postoperative narcotic medication and lower rates of urinary~     retention.~   "
220176|NCT00676923|"~     The goal of this project is to examine the physical mechanisms that contribute to~     improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of~     bariatric surgery.~   "
214893|NCT00746850|"~     In the developmental stage of laparoscopic cholecystectomy it was considered 'unsafe' or~     'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis. With~     increasing experience in laparoscopic surgery, a number of centers have reported on the use~     of laparoscopic cholecystectomy for acute cholecystitis, suggesting that it is technically~     feasible but at the expense of a high conversion rate, which can be up to 35 per cent and~     common bile duct lesions.~      The HARMONIC SCALPEL® (H) is the leading ultrasonic cutting and coagulating surgical device,~     offering surgeons important benefits including: minimal lateral thermal tissue damage,~     minimal charring and desiccation.~      H technology reduces the need for ligatures with simultaneous cutting and coagulation:~     moreover there is not electricity to or through the patient H has a greater precision near~     vital structures and it produces minimal smoke with improved visibility in the surgical~     field.~      In retrospective series LC performed with H was demonstrated feasible and effective with~     minimal operating time and blood loss: it was reported also a low conversion rate (3.9%).~      However there are not prospective randomized controlled trials showing the advantages of H~     compared to MD (the commonly used electrical scalpel) in LC.~      Aim of this RCT is to demonstrate that H can reduce conversion rate compared to MD in LC for~     AC.~   "
214894|NCT00746837|"~     The purpose of the study is to estimate the absolute bioavailability at steady state of 2~     doses of AZD5672 (50 mg and 150 mg administered orally once daily)~   "
214895|NCT00746824|"~     The purpose of this study is to determine the effects of TM30339 on weight loss in obese~     individuals after 28 days dosing.~   "
214896|NCT00746811|"~     The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo,~     on LDL-C and other aspects of the fasting lipid profile in subjects with primary~     hypercholesterolemia.~   "
214897|NCT00746798|"~     The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and~     effective in preventing West Nile disease in adults over 50 years of age.~   "
214898|NCT00746785|"~     Craving for alcohol has been related to loss of control drinking and is a major target of~     biological and behavioral interventions for alcohol dependence. Our previous research has~     demonstrated that olanzapine (a dopamine antagonist) attenuates craving for alcohol, that a~     variant in the gene that expresses D4 receptors influences craving for alcohol, and that~     olanzapine is particularly effective at reducing craving among individuals with this variant.~     Pilot data from a recent 12 week trial of olanzapine indicates that olanzapine is well~     tolerated and that olanzapine reduces drinking, particularly among individuals with the~     aforementioned genetic variant. The objective of the present application is to examine the~     effectiveness of olanzapine (5 mg/day), as compared to olanzapine (2.5 mg/day) and a placebo~     control, in terms of reducing craving and alcohol use behavior among treatment seeking~     alcoholics. Furthermore, the present application will examine whether the effects of~     olanzapine on drinking outcomes are mediated by its effects on a specific putative mechanism~     (i.e., cue-elicited craving for alcohol) and determine whether the DRD4 VNTR polymorphism is~     a marker for the effectiveness of olanzapine. To that end, 202 alcohol dependent subjects~     will be randomly assigned to medication group and receive 12 weeks of medication. Subjects~     will complete follow-up assessments at 3 and 6 months after the end of the treatment. It is~     expected that olanzapine will significantly reduce cue-elicited craving and alcohol use~     behavior in a dose dependent fashion over the course of the 12 week trial and follow-up~     period, as compared to the placebo condition. Furthermore, it is expected that the effects of~     olanzapine on alcohol use behavior will be mediated by the effect of olanzapine on~     cue-elicited craving and that the effects of olanzapine on cue-elicited craving and alcohol~     use behavior will be moderated by the DRD4 VNTR, such that olanzapine will be more effective~     among individuals with the 7 repeat allele. The successful completion of the proposed~     research is expected to advance a new medication for alcohol dependence and advance genetic~     markers that predict the effectiveness of this medication.~   "
214899|NCT00746772|"~     Oral lichen planus (OLP) is a chronic inflammatory disease whose prevalence in the general~     population is 0.5 -2.2%.Oral lesions in OLP are chronic, rarely undergo spontaneous~     remission. Patients with OLP had significantly increased risk of oral squamous cell~     carcinoma, irrespective of the clinical type of OLP and therapy. there is currently no cure~     for OLP. Previous study demonstrated a decreased antioxidant defence and increased oxidative~     damage to lipids.DNA and proteins in lichen planus. This oxidative modifications point to~     pathophysiological alterations mainly within the basal cell layers of epidermis and at the~     dermoepidermal junction. Purslane is an excellent source of vitamin A,C and E and essential~     amino acids, has been described as a power food of the future because of its high nutritive~     and antioxidant properties. The purpose of the study was to determined the efficacy of~     Purslane in the treatment of oral lichen planus.~   "
214900|NCT00746759|"~     The purpose of the research study is to develop a new, more sensitive, and less invasive test~     for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The~     investigators hypothesize that certain genes are expressed differently in current and former~     smokers who have lung cancer, and this difference in gene expression may be a biomarker for~     lung cancer.~   "
214901|NCT00746746|"~     The purpose of this study is to determine the safety of giving subjects with advanced,~     recurrent or refractory melanoma the HyperAcute® Melanoma vaccine with a variant of a drug,~     called Interferon (PEG-Intron®) that is specially formulated to be given on a weekly basis~     (instead of daily). The study vaccine (HyperAcute®-Melanoma) is made from three types of~     human melanoma cell lines (grown in the laboratory) in which the genes have been slightly~     changed. This clinical study will try to discover the safety of the study vaccine combined~     with PEG-Intron®, its side effects and the potential benefits, if any.~   "
214902|NCT00746733|"~     The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR~     with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how~     much of the drug is absorbed into the body.~   "
214903|NCT00746720|"~     The purpose of this study is to test the hypothesis that orally administered etoricoxib~     (COX-2) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS)~     and in the periphery in surgical patients and thus reduces pain and suffering.~   "
214904|NCT00746707|"~     The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for~     first degree perineal tears repair~   "
214905|NCT00746694|"~     The objective of this trial is to study the management of PPE in participants with metastatic~     ovarian or breast cancer treated with Caelyx, and determine the frequency of use of~     pharmacological treatment (preventive or therapeutic) for PPE and compliance of educational~     recommendations for PPE.~   "
214906|NCT00746681|"~     Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is~     designed to a investigate whether pregabalin may have efficacy in OAB and whether the~     efficacy is altered when it is combined with tolterodine.~   "
214907|NCT00746668|"~     The purpose of this study is to measure the effectiveness of a newly-designed oculomotor~     training program for patients with macular disease, including age-related macular~     degeneration.~   "
214908|NCT00746655|"~     The purpose of this study is to determine the feasibility and toxicity of combining SBRT and~     TACE for unresectable HCC and to evaluate the Health Related Quality of Life (HRQL)~     associated with combined therapy.~   "
214909|NCT00746642|"~     Most patients with diabetes mellitus have to measure their blood glucose levels quite often,~     in order to maintain a proper glycemic control. Current methods of self-monitoring of blood~     glucose are invasive, painful, uncomfortable, and only allow occasional, from time-to-time,~     measurements. Real-time continuous monitoring would provide a helpful tool for improvement of~     glycemic control, thus decreasing the incidence of hypoglycemia and improving glucose~     control. The Mellitor sensor is a new concept of continue glucose monitoring device. The~     Mellitor device is an implantable continuous glucose monitoring sensor that is intended for~     detection episodes of hyperglycemia and hypoglycemia in diabetic patients, and facilitates~     both acute and long-term therapy adjustments. This study was design in order to evaluate~     glucose measurement capabilities by the Mellitor sensor that is being developed. Transudate~     liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be~     used for glucose measurement by the Mellitor sensor.~      Study Design~      This study is an ex-vivo comparative study. 20 patients will be recruited for the study,~     according to patients' inflow and meeting eligibility criteria.~      Study Goal~      Study objective is to evaluate the feasibility of the Mellitor Sensor technology for glucose~     level measurement.~      Study Endpoint~      Mellitor technology feasibility will be established by comparing Mellitor glucose~     measurements results, based on transudate/exudates liquid withdrawal for other medical~     reasons, to gold standard, Yellow Springs glucose analyzer, or a comparable, calibrated and~     approved device using the same transudate/exudates liquid. Interdevice variability should be~     within 10%.~   "
214910|NCT00746629|"~     The purpose of this study is to compare the efficacy of two different approaches (prescribed~     & self-directed) to the treatment of childhood obesity and their relative impact on child~     weight status, physical activity, and diet.~   "
214911|NCT00746616|"~     The purpose of the study is to gather clinical information on the safety and efficacy of the~     resurfacing devices in the young, active patient with advanced hip disease. Study enrollment~     has been temporarily suspended due to a change in the surgical technique.~   "
214912|NCT00746603|"~     Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm~     survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus,~     the emphasis for future therapeutic interventions must include attention to the late effects~     of therapy. The development of cardiovascular disease as a late effect of radiation therapy~     has been well described and documented. Our recent pilot study of child and young adult HD~     survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid~     Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were~     positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic~     BP. This finding was present in children and young adults who had received no or low dose~     radiation suggesting that chemotherapy or the disease process itself contributes to the~     development of atherosclerosis and risk for cardiovascular disease. Numerous studies have~     shown HMG CoA reductase inhibitors (statins) to be effective in reducing the progression of~     atherosclerosis in adults. These agents have been studied in children and young adults for~     over a decade.~      The primary aim of this study is:~      To obtain pilot safety data on the use of simvastatin in young adults treated for HD.~      The secondary aims of this study are:~      To obtain pilot data on the effect of simvastatin on subclinical carotid artery~     atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD.~      To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the~     serum of young adults treated for HD.~      To obtain pilot data to serve as the basis for the development of a multicenter randomized~     study for the use of simvastatin in survivors of HD.~   "
214913|NCT00746590|"~     This an open-label study designed to evaluate the anti-tumour activity and safety of Prolarix~     in subjects with advanced hepatocellular carcinoma.~      Prolarix is a chemotherapy comprised of tretazicar as prodrug and caricotamide as~     co-substrate for the endogenous enzyme, NQO2.~   "
214914|NCT00746577|"~     Purpose of the Study:~      The Richmond Behavioral Health Authority's Substance Abuse Services Division and Virginia~     Commonwealth University's Institute for Drug and Alcohol Studies are working on an important~     research study to improve the quality of substance use disorder treatment services offered by~     RBHA and its contracted services providers. Specifically, this preliminary research will~     provide the information needed to conduct a planned series of program-specific interventions,~     designed to increase the adoption of evidence-based practices (EBPs) within specific~     programs. A major goal of the study is to better understand what factors influence the~     adoption of EBPs, and what adoption strategies work best for which types of staff, which~     types of programs, and under what conditions.~      Description of Staff Involvement:~      In this study, staff will be asked to complete questionnaires about themselves, their~     workplaces, and their perceptions about the services their organization provides. Some of~     these questionnaires will be given to staff when they first enter the study, and others may~     be given to staff before and about 9 months after a 3-day Practice Improvement Workshop~     (please note that each agency may or may not be selected to complete the workshop).~      Description of Client Involvement:~      Clients at each participating site will be asked to complete a brief survey about the~     services they receive at that site. This survey will occur at the initial timepoint, and at~     several later timepoints. This survey is confidential and anonymous.~   "
214915|NCT00746564|"~     The goal of this IDE clinical study is to evaluate the quality of the cardiac signal~     recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor~     (device).~   "
214916|NCT00746551|"~     The purpose of this study is to compare the efficacy of body iron storage replenishment~     between low dose intravenous iron and oral iron in late pregnancy.~   "
214917|NCT00746538|"~     The purpose of this study is to compare the quality of life in patients with unresectable~     hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent.~   "
214918|NCT00746525|"~     The purpose of this trial was to evaluate the benefits of combination motor learning training~     and brain computer interface training for restoring arm function in people with stroke. Our~     aim was to determine whether the surface-acquired brain signal (electroencephalography (EEG))~     can feasibly be used as a neural feedback system to drive more normal motor function in~     stroke survivors.~   "
214919|NCT00746512|"~     The study will compare the effects of prednisone vs placebo on synovial blood flow and~     overall DAS (disease activity score) in patients with rheumatoid arthritis.~   "
214922|NCT00746473|"~     A cross-sectional study was performed on HIV-1 infected individuals with or without~     antiretroviral treatment. 73 HIV-1 infected individuals were divided into three groups: G1=~     15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on~     HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31~     patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4=~     20 individuals chosen between blood donors without any disease sign and with negative HIV~     serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression~     by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All~     patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results~     analysis showed a significant comparison between groups for both methods and association~     between them (>80% - r2>0.80) with only one exception, in the individuals of control group,~     for IL-2 by ELISA determination. The cytokine profile for both methods and three patient~     groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent~     expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g~     values in the three patient groups.~   "
214923|NCT00746460|"~     The investigators hypothesize that having health care providers other than physicians within~     a Groupe de Médecine de Famille conduct cardiovascular risk assessments and teach lifestyle~     interventions to primary prevention patients will increase the likelihood that patients will~     adopt and maintain healthy lifestyles. These objectives will be supported by providing~     subjects with a cardiovascular risk profile estimating the subject's risk of cardiovascular~     disease and teaching them how to use the resources related to lifestyle changes available on~     the www.myhealthcheckup.com Web site.~   "
214924|NCT00746447|"~     This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine~     granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine~     granules for maintenance of remission in patients with ulcerative colitis~   "
214925|NCT00746434|"~     The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal~     roflumilast cream in the treatment of plaque psoriasis in adults. This is a multicenter,~     randomized, double-blind, placebo-controlled, parallel group study. 3-10 % of the body~     surface area (BSA) should be covered with a mild to moderate form of plaque psoriasis. In a~     4-week treatment period 76 mg cream is applied two times daily on up to 2% of the BSA. After~     a screening phase, a washout phase of flexible duration (max 30 days, time depending upon~     pre-medication), the 28 day treatment phase follows. As roflumilast is a potent~     anti-inflammatory substance, a positive effect on this form of dermal disease is anticipated.~   "
214926|NCT00746421|"~     Quetiapine has been reported to have beneficial cognitive effects in several randomized~     controlled trials in schizophrenia. It has not yet been studied in bipolar disorder, but~     promising results from the use of extended release quetiapine for the maintenance treatment~     of bipolar disorder suggests that its cognitive benefits could be detected. Moreover,~     quetiapine has been shown to have direct beneficial effects on performance-based measures of~     social competence in schizophrenia and to improve quality of life (QoL) in bipolar~     depression. The investigators propose to study quetiapine augmentation of mood stabilizer~     monotherapy in clinically stable patients with bipolar disorder. This will be a randomized,~     placebo controlled trial, with attentional impairments as the primary outcome and other~     cognitive performance variables and measures of social and everyday living skills, as well as~     subjective QoL, as the secondary outcomes.~   "
214927|NCT00746408|"~     Medical expert systems in combination with portal searching meta-search engines are exploited~     to provide reliable patient-tailored information. A prototype of a web-based information~     system has been developed and is to be evaluated. Its aim is to answer the decisive question~     whether expert system guided internet meta-search provides a better information supply for~     patients seeking health information online then this is possible by using ordinary search~     engines or health portals. The research does neither investigate the influence of ethical nor~     legal aspects of internet health information supply.~   "
214928|NCT00746395|"~     This investigation is designed to compare lubiprostone and placebo for cleansing and~     propulsion in preparation for capsule endoscopy.~   "
214929|NCT00746382|"~     The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal~     roflumilast cream in the treatment of atopic dermatitis in adults. This is a multicenter,~     randomized, double-blind, placebo-controlled, parallel group study. 2-5 % of the body surface~     area (BSA) should be covered with a mild form of atopic dermatitis. In a 4-week treatment~     period 38 mg cream is applied two times daily on 0.5 to 1 % of the BSA. After a screening~     phase, a washout phase of flexible duration (max 30 days, time depending upon~     pre-medication), the 28 day treatment phase follows.As roflumilast is a potent~     antiinflammatory substance, a positive effect on this form of dermal disease is anticipated.~   "
214930|NCT00746369|"~     The IMARA Program will test the efficacy of a multi-session HIV Prevention program, adapted~     from an existing program(SiHLE), for incarcerated African American adolescent females.~   "
214931|NCT00746356|"~     This study is a prospective, non-randomized, multi-center clinical trial that will assess the~     safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF~     ICD devices. These new ICD and CRT-D devices have new features that allow the device to~     periodically check how much energy is needed to pace a patient's heart and to automatically~     adjust the amount of energy used to pace the heart.~   "
214932|NCT00746343|"~     The primary aim of this project is to understand whether it is possible to reduce medical~     risk factors in adults with bipolar disorder and, in doing so, to improve psychiatric and~     functional outcomes. We will examine the role of behavioral risk factors and presumed~     behavioral mediators and moderators of health risk in individuals suffering from bipolar I~     disorder. The investigators will employ an innovative behavioral intervention with guideline~     based psychiatric care ( Integrated Risk Reduction Intervention - IRRI) in order to target~     modifiable medical risk factors.~   "
214979|NCT00745719|"~     To test the hypothesis that total parathyroidectomy retards cardiovascular calcification,~     improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in~     end-stage renal disease patients on maintenance dialysis.~   "
215228|NCT00742430|"~     The purpose of this study is to determine whether aspirin and clopidogrel resistance measured~     with Multiplate function analyser has a good correlation with incidence of major adverse~     cardiac events in patients with coronary artery disease (CAD).~   "
214933|NCT00746330|"~     This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and~     duration of action), of a single dose of formoterol fumarate in combination with mometasone~     furoate to placebo in children of 5-11 years with persistent asthma. The study will also~     assess the bronchodilatory effect of a single dose of formoterol fumarate alone and in~     combination with mometasone furoate delivered via a pressurized metered dose inhaler (pMDI)~     to the bronchodilatory effect of formoterol fumarate delivered via a dry powder inhaler~     (DPI). Furthermore, pharmacokinetic assessments of plasma and urine will also be conducted~     throughout the study to assess systemic exposure following administration of the study~     medication.~   "
214934|NCT00746317|"~     This phase I trial is studying the safety and best dose of GC33 in patients with advanced or~     metastatic liver cancer.~   "
214935|NCT00746304|"~     To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy~     for infantile and acquired esotropia.~   "
214936|NCT00746291|"~     to investigate the function of the autonomic nervous system in children with with post~     traumatic brain injury and children with cerebral palsy through an analysis of heart rate~     variability (HRV) occurring with walking performance.~   "
214937|NCT00746278|"~     Laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but~     damage to ovarian reserve caused by electrocoagulation has recently been questioned.~      The purpose of this study is to investigate the impact of bipolar and ultrasonic scalpel~     electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.~   "
214938|NCT00746265|"~     This project compares gold standard cognitive-behavioral therapy (based on LEARN, Diabetes~     Prevention Program, LOOK Ahead) used in both research and clinical settings, with~     acceptance-based behavioral therapy for weight loss. Standard behavior treatment (SBT)~     focuses on modifying eating, thinking, and activity levels. Participants limit their daily~     caloric intake, keep food records, increase physical activity, and practice weight control~     behaviors, such as stimulus control, cognitive restructuring, alternative coping skills, and~     distinguishing hunger from cravings. The acceptance-based approach (ABT) incorporates the~     behavioral and nutritional components, but replaced the cognitive and motivational components~     with components that are consistent with an acceptance-based approach, such as acceptance and~     willingness to experience cravings, cognitive defusion, mindfulness training to interrupt~     automatic eating, and values work. These components are drawn from Acceptance and Commitment~     Therapy (ACT; Hayes, Strosahl, & Wilson, 1999), a cognitive-behavioral therapy that has been~     gaining increasing attention and empirical support (Bach & Hayes, 2002; Bond & Bunce, 2000;~     Hayes et al. 2004). Though relatively new, acceptance-based strategies have demonstrated~     effectiveness in helping individuals to respond to unwanted thoughts and feelings (Hayes,~     Rissett, Korn, Zettle, Rosenfarb, Cooper, & Grundt, 1999, Keogh, Bond, Hanmer, & Tilston,~     2005) and offer a novel alternative to control-based strategies (such as distraction and~     confrontation).~      Participants in this study will be randomly assigned to either the traditional behavioral~     therapy condition (SBT) or the acceptance-based behavioral therapy condition (ABT). Both~     conditions are delivered in group format. A total of 30, 75 minute sessions will take place~     over the course of 40 weeks.~      Specific Aims~        1. To evaluate the feasibility and acceptability of the treatment, and its short and~          moderate-term effectiveness relative to the current gold standard behavioral treatment~          (SBT).~        2. To evaluate the effectiveness of ABT with novice clinicians and with weight control~          experts.~        3. To evaluate the effectiveness of ABT would be moderated by mood disturbance, emotional~          eating, disinhibition or susceptibility to food stimuli.~   "
214939|NCT00746252|"~     The purpose of this study is to learn more about weight gain and related side effects when~     children are treated with antipsychotic medicine for mood disorders.~   "
214940|NCT00746239|"~     Almost 80% of panic disorder patients report difficulty sleeping. Sleep disturbances in turn~     may exacerbate underlying anxiety/panic attacks. Moreover, individuals with insomnia (sleep~     disturbance) are at higher risk of developing a new anxiety disorder. Therefore it is~     expected that improving sleep quality with medications along with other medications to treat~     anxiety component of panic disorder might be helpful. However, there is lack of~     pharmacological studies examining the effects of improving sleep disturbances with~     medications in panic disorder patients, which is a critical problem for providing optimal~     care to these patients. The objective of this proposal is to determine the effects of~     ramelteon (FDA approved for insomnia) on sleep disturbances in Panic disorder patients who~     are on escitalopram for underlying anxiety.~   "
214941|NCT00746226|"~     Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic~     countries. Treatment consists of antihistamine use. Specific probiotic strains have been~     observed to modulate the immune system. Since the body has a common mucosal immune system; it~     was hypothesised that consumption of probiotics may affect also the respiratory mucosal~     immune response and hence affect respiratory allergy.~      Earlier studies with probiotics had been unable to show improvements in adults with pollen~     allergy. It was therefore hypothesised that children, who's immune system is not yet fully~     developed, might be better targets.~   "
214942|NCT00746213|"~     This is an investigation on the frequency of chronic pain after thoracotomy for lung cancer.~     Factors relating to the development of chronic pain are investigated. Questionnaire survey.~   "
214943|NCT00746200|"~     Since there have been few advances for constipation in laxative treatment in the last 50~     years, this study is designed to evaluate the efficacy and safety of acupuncture for patients~     with chronic constipation based on the theory of traditional Chinese Medicine.~   "
214944|NCT00746187|"~     The purpose of this study is to compare marginal bone level changes between ASTRA TECH~     Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial~     edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical~     protocol will be used. Implants will be loaded within 15 weeks from installation. The~     subjects will be followed for 3 years.~   "
214945|NCT00746174|"~     This study will include subjects with an abnormal glucose tolerance test. Using a crossover~     design, we will evaluate the insulin sensitivity and intracellular lipid content of the~     heart, liver and skeletal muscle of subjects before and after therapy with Rosiglitazone and~     placebo. We hypothesize that Rosiglitazone will improve insulin sensitivity in association~     with reduced muscle lipid content that may arise either from increased lipid oxidation or~     enhanced storage of fat in adipose tissue.~   "
214946|NCT00746161|"~     The purpose of this study is to evaluate the double tract reconstruction after total~     gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was~     conducted to compare double tract method with Roux-en-Y method~   "
214990|NCT00745576|"~     The purpose of this study is to evaluate the effects of multiple doses of verapamil on the~     plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to~     assess the safety and tolerability of co-administration of SAM-531 and verapamil.~   "
215229|NCT00742417|"~     The purpose of this study was to evaluate the efficacy and safety of plasma exchange with 5%~     albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in patients~     with mild-moderate Alzheimer's disease.~   "
214947|NCT00746148|"~     Polycystic Ovary Syndrome (PCOS) is very common, affecting approximately 5% of women of~     reproductive age, and impacts not only on quality of life, but also has long-term health~     consequences for many sufferers, such as increased risks of developing Type II diabetes,~     cardiovascular disease and cancer of the womb. The symptoms that may occur such as irregular~     periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to~     poor self-esteem. Whilst treatments can help fertility, other treatments to correct the other~     symptoms are less successful. Alternative methods to regulate periods would be helpful,~     especially ones which avoid the long-term use of steroids in patients who may already be~     overweight. Reflexology is poorly represented in scientific papers, with nothing published~     regarding reflexology and its effect upon PCOS. However patients who use reflexology report~     more regular periods, thicker hair on scalp and greater wellbeing. Therefore we aim to~     investigate the effect of reflexology on:~        1. The menstruation cycle (normal being every 21-35 days).~        2. Imbalances in hormone, insulin and blood sugar levels associated with PCOS.~        3. Other problems associated with PCOS such as thinning hair on scalp, excessive body hair,~          and obesity.~        4. Quality of life. Government and NHS agendas agree that if there's evidence of an~          effective complimentary therapy the NHS should provide it. Therefore the results may~          have an influence on the care pathways of patients with PCOS towards a more holistic,~          patient centred and empowered approach. It is also non invasive and liable to result in~          higher patient satisfaction regarding their treatment. This research may also inform~          policy makers so that complementary medicine provision is provided on a wider basis~          within the NHS, which at the moment is dictated by the individual Trust's budget~          allocation. However this research could save money overall as in America, the yearly~          cost of treating PCOS is $4.36 billion.~   "
214948|NCT00746135|"~     It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position~     (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually~     optimized Left Ventricular (LV) lead placement and CRT timing on the outcome of cardiac~     resynchronization therapy (CRT).~   "
214949|NCT00746122|"~     The purpose of this trial is to assess whether a strategy of endovascular repair (if aortic~     morphology is suitable, open repair if not) versus open repair reduces early mortality for~     patients with suspected ruptured abdominal aortic aneurysm.~   "
214950|NCT00746109|"~     Superficial skin and soft tissue abscess are frequently managed by opening them up with a~     procedure called incision and drainage. It is routine practice in the United States to~     place packing material inside the abscess cavity after opening them up, in order to promote~     better wound healing and limit abscess recurrence. However, this practice has never been~     systematically studied or proven to decrease complications or improve healing. Patients with~     wound packing usually return to the emergency room or practice setting for multiple wound~     checks and dressing/packing changes which lead to missed days from work or school and~     utilization of healthcare resources. This procedure can often be painful and may even require~     conscious sedation (and the risks entailed) especially in children. With rates of superficial~     skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it~     is important to determine whether packing wounds is necessary or even advantageous to~     patients.~      This study is the first to systematically evaluate the efficacy of wound packing after~     superficial skin or soft tissue abscess incision and drainage in children. The investigators~     will be evaluating wound healing, complications, recurrence and pain associated with packing~     both short and long term. In addition, the investigators will also be evaluating the utility~     of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess~     cavity. This test may be useful to determine whether incision and drainage is necessary for~     an individual who has a skin infection that is suspicious for an abscess.~   "
214951|NCT00746096|"~     The purpose of this study is to determine whether combination oral contraceptive pill of~     norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.~   "
214952|NCT00746083|"~     The purpose of Challenge! is to determine if adolescents enrolled in a health promotion/~     obesity prevention program will have a healthier BMI-for-age z-score and body composition~     (body fat %), will consume a healthier diet, and engage in higher levels of physical activity~     compared to those that did not receive the intervention over time.~   "
214953|NCT00746070|"~     Primary aldosteronism (PA), characterized by an inappropriate production of aldosterone, is~     far more common than is usually perceived. The overall prevalence of PA is 11.2% of the newly~     diagnosed hypertensive patients and 4.8% was curable aldosterone producing adenoma (APA), and~     adrenalectomy is considered the treatment of choice for APA. The potential curability and~     prevention of excess cardiovascular damage and events also underscores the need to develop~     accurate strategies for the timely diagnosis of APA.This study aimed to determine the effects~     of endothelium function change ( PWV, progenitor cell,..) before and post-adrenalectomy or~     taking spironolactone in patients with aldosteronism. Autonomous elevated aldosterone will~     increase the glomerular filtration rate and renal damage in patients with primary~     aldosteronism (PA). But clinical evidence of the role of endothelium function on~     post-adrenalectomy or taking spirolactone is still limited.~   "
214954|NCT00746057|"~     The aim of the study is to explore the possibility to identify, at an early stage after a~     renal graft and from blood samples collected within first months after graft, a predictive~     transcriptional profile of long term occurence of graft operational tolerance or chronic~     rejection.~      The aim of the study is to determine an early transcriptional profile of chronic rejection in~     the transcriptome of mononuclear blood cells. Validation and predictivity of transcriptional~     analysis will be based on graft function and graft histology one year after~     transplantation.The other aim is to determine an early transcriptional profile of operational~     tolerance in the same patients using a DNA chip dedicated including two lists of genes~     discriminating tolerant patients who are stopped immunosuppressant treatment for over a year.~      To allow statistical analysis of 100 patients followed one year after graft, patients not~     assessable at one year due to early termination of study will be replaced.~   "
214955|NCT00746044|"~     Human Multidrug Related Protein 2 (MRP2) excretes several drugs and could therefore modulate~     their elimination. Individual's MRP2 activity is under genetic control. Thus it would be very~     useful to get an easily measurable biomarker reflecting individual's MRP2 activity. We aimed~     to investigate the ratio of urinary coproporphyrins I and III (UCP(I/I+III), known to be~     increased in patients with mutations in MRP2/ABCC2 gene.~   "
215028|NCT00745069|"~     The purpose of this study was to examine a low and high dose of tapentadol extended release~     tablet taken orally twice a day to reduce pain in subjects suffering from chronic moderate to~     severe pain due to osteoarthritis of the knee during a 4-week period. Subjects steadily~     increased their dose up to the low (100 mg) or high (200 mg) dose. Pain relief was compared~     to subjects taking placebo tablets or oxycodone extended release tablet, 20 mg. The serum~     concentrations and safety of tapentadol and oxycodone were also examined.~   "
214956|NCT00746031|"~     Fibroids are present in up to 80% of women of reproductive age. Associated heavy menstrual~     bleeding is often an indication for surgery. At present there are no long-term medical~     treatments for fibroids. There is an unmet need for a pharmacologic agent able to reduce~     excessive bleeding and other symptoms associated with increased uterine volume, which could~     prevent or significantly delay surgery without causing significant unwanted hypoestrogenic~     side effects and allow preservation of fertility.~      The purpose of this study is to investigate and validate novel MR imaging as a non-invasive~     biomarker for monitoring responses to medical interventions aimed at reduction of excessive~     menstrual bleeding and decrease in uterine/ fibroid volume. MR imaging is non-invasive, does~     not involve ionizing radiation and new techniques have the potential to resolve tissue detail~     to near cellular level.~      The investigators are aiming to establish the feasibility and reproducibility of novel MR~     imaging techniques in the evaluation of treatment response in women with fibroids and to~     provide mechanistic information on whether the reduction in blood flow of uterine/fibroid~     vasculature in the shrinkage of fibroids is dependent upon subjects being hypoestrogenic.~   "
214957|NCT00746018|"~     Some patients, specifically those with a diagnosed genetic mutation, will have their ovaries~     and fallopian tubes removed without removal of the uterus in an attempt to prevent ovarian~     and fallopian tube cancer from developing.~      Anatomically the fallopian tubes are attached to the uterus and extend towards the ovaries.~     The fallopian tube tissue arises within the corner area of the uterus and occupies about 1cm~     of the uterine muscle wall.~      The purpose of this study is to determine if the technique used to remove fallopian tubes~     only (without removal of the uterus) adequately removes or destroys all the fallopian tube~     cells that remain in the uterine muscle wall.~      Currently, during the operation an instrument is used that burns the fallopian tube and~     allows it to be cut away from the uterus. The investigators do not know if this procedure~     successfully destroys all the fallopian tube cells within the uterus. Therefore, we will~     compare this single step procedure to a two step procedure. The two step procedure is to burn~     and cut the fallopian tube followed by an additional burning step, called cauterization at~     the top of the uterus. The investigators will assess if either or both of these procedures~     destroy the fallopian tube cells that may remain inside the uterine wall. This is important~     to determine since the goal is to remove the ovaries and all of the fallopian tubes in order~     to prevent future development of ovarian or fallopian tube cancer.~   "
214958|NCT00746005|"~     To study the short term effects of a pharmacological dose of fish oil on cognitive~     performance and on cerebral blood flow. Furthermore, we want to investigate whether carriers~     of the APOEε4 allele respond differently to fish oil treatment compared to non-carriers.~   "
214959|NCT00745992|"~     Voriconazole is an effective antifungal agent and may decrease morbidity and mortality for~     patients with invasive fungal infections. It is metabolized via liver enzymes. However, these~     enzymes exhibit different activities in individual patient (genetic polymorphism). Higher~     proportions of Asians metabolize voriconazole slower than Caucasians and African Americans~     do. Slower metabolizers may experience dose-associated adverse events more frequently, such~     as visual disturbances, liver function test abnormalities, and neurological complications. On~     the other hand, extensive metabolizer or other physiologic conditions may lead to lower blood~     levels of voriconazole, which may result in treatment failure.~      We plan to enroll patient who take voriconazole and examine their liver enzyme activities and~     blood samples for peak and trough drug levels. We will collect potential factors affecting~     voriconazole levels, and correlate the levels with the dosing regimen, activity of liver~     enzyme, occurrence of adverse events, and treatment outcomes. The goal of this study is to~     determine if monitoring of voriconazole blood levels is necessary in Taiwan.~   "
214960|NCT00745966|"~     The purpose of this study is to reassure the clinical study data on atypical antipsychotics~     effect on quality of life in Korean Bipolar patients.~   "
214961|NCT00745953|"~     Traditionally, obesity is considered an indirect cause of heart disease. Obese individuals~     typically present with a number of traditional Framingham risk factors (hypertension,~     dyslipidemia, and type 2 diabetes), predisposing them to heart attacks and subsequent heart~     failure. However, an emerging body of basic research revisits a hypothesis that fat is a~     direct cardiotoxin. Under healthy conditions, most triglyceride is stored in fatty tissue~     (adipocytes) while the amount of triglyceride stored in non-adipocyte tissues (such as the~     pancreas, the liver, skeletal muscle, and heart) is minimal and very tightly regulated. When~     this regulation is disrupted, intracellular triglyceride accumulates excessively in these~     organs (steatosis) and has been implicated in activating adverse pathways which culminate~     in irreversible cell death (lipotoxicity), leading to several well-recognized clinical~     syndromes. These include non-alcoholic steatohepatitis (NASH), pancreatic beta-cell failure~     in type 2 diabetes, and dilated cardiomyopathy.~      It has been recently observed that angiotensin II receptor blockers (ARBs) in addition to~     lowering blood pressure improve insulin sensitivity and decrease the risk for type 2~     diabetes. This study will test the above theory in two study groups: Valsartan vs.~     Hydrochlorothiazide. We hypothesize that in obese humans with elevated myocardial~     triglycerides, blockade of the renin-angiotensin system (Valsartan group) will reduce~     myocardial fat with improvement of insulin sensitivity and heart function.~   "
214962|NCT00745940|"~     The purpose of this study is to determine whether mindfulness-based cognitive therapy is~     effective in reducing depression symptoms in individuals who have experienced a traumatic~     brain injury.~      The investigators hypothesize that participants who are given the ten-week intervention will~     have fewer depression symptoms than the participants in the control group, and this~     improvement will be maintained at the three-month follow-up assessment.~   "
214978|NCT00745732|"~     Primary Objectives:~        -  To assess the safety of oral therapy with ZD6474 by evaluating the frequency, severity,~          and duration of treatment-emergent adverse events in patients with poor prognosis lung~          cancer.~        -  To record the extent, frequency and duration of any tumor responses to this treatment~          regimen and assess whether ZD6474 augments the efficacy of radiation therapy in~          non-small cell lung cancer patients.~        -  To determine the recommended phase II dose of ZD6474 for future clinical studies with~          radiation therapy.~      Secondary Objectives:~        -  To determine the effects on metabolism and angiogenic factors by positron emission~          tomography (PET) scan/computed tomography (CT) scan , vascular endothelial growth factor~          (VEGF), and circulating endothelial cell levels in patients treated with ZD6474 and~          radiation therapy.~   "
214963|NCT00745927|"~     It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and~     abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy~     even under sedation has been already assessed in some earlier trials. Air insufflation is~     still the standard method, however, because of a lack of suitable equipment and continued~     technical improvement in colonoscopy.~      In laparoscopic surgery, CO2 insufflation is widely applied and safely used with the patient~     under general anesthesia. CO2 insufflation is also applied for CT colonography for reduction~     of discomfort during or after procedure.2 During endoscopic procedure for colorectal~     neoplasia resection, however, long procedural time may increase not only the degree of~     discomfort during and after the procedure but also the risk of perforation. In addition to~     laparoscopic surgery, CO2 insufflation has also been applied to other endoscopic procedures.~     Saito et al reported the application of CO2 insufflation in Endoscopic submucosal dissection~     (ESD) of colorectal neoplasia in a prospective study in which their average procedural time~     using CO2 insufflation was 90 minutes under conscious sedation with average of 5.6 mg of~     midazolam. When compared with control group using room air, statistically negligible~     difference of pCO2 was observed with significant difference in abdominal discomfort.6~     Screening colonoscopy, which can be completed within 15 minutes if no lesion being detected,~     requires high screenee satisfaction so as to improve patient compliance. In the setting of~     colonoscopy after positive FOBT, the attendance rate for secondary colonoscopy was around 60~     to 70 % according to the data demonstrated in previous RCT and population-based studies. With~     application of CO2 insufflation, further improvement of patient compliance can be~     anticipated.~      This study aims to investigate whether use of CO2 insufflations can reduce examinee~     discomfort in comparison with air.~   "
214964|NCT00745914|"~     To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque~     regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property.~   "
214965|NCT00745901|"~     The purpose of this study in healthy sexually active females is to evaluate the cycle control~     with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.~   "
214966|NCT00745888|"~     In clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute~     lung injury, and acute respiratory distress syndrome. There are some questions on the~     oxidative stress of the critical illness. First, the investigators want to search out the~     effects of the past history, smoking, alcohol drinking, use of antioxidants, different~     diseases, and different duration of SIRS on the degree of oxidative stress. Second, besides~     total count of ROS, the investigators used new techniques to determine superoxide(O2●-),~     hydrogen peroxide (H2O2), and hypochlorous acid(HOCl). Furthermore, we want to investigate~     the correlation of the degree of different reactive oxygen species and the severity of SIRS~     or shock. Third, we try to investigate the correlation between the change of oxidative stress~     and the prognosis of the patients.~      The investigators wish this study will help them to investigate the effect of oxidative~     stress on critical ill patients, to modulate the oxidative stress, to decrease the occurrence~     of SIRS, shock, and multiorgan failure, and to improve the long term outcome of patients.~   "
214967|NCT00745875|"~     The aim of this study is to collect initial efficacy and safety data on the use of a new~     treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard~     chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment~     with pemetrexed alone~   "
214968|NCT00745862|"~     The purpose of this study is to examine the experiences and quality of life of women who have~     been treated for melanoma. By quality of life, we mean how they are feeling about different~     aspects of their life. In this study, we are especially interested in their feelings about~     survival, physical appearance and any family concerns. We will administer a series of QOL~     questionnaires, data sheets with many questions, to get their response to measure their~     feelings about these issues.~   "
214969|NCT00745849|"~     The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in~     treating non-allergic rhinitis~   "
214970|NCT00745836|"~     High dose atorvastatin may worsen insulin sensitivity.~   "
214971|NCT00745823|"~     A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared~     to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve~     human immunodeficiency virus (HIV)-infected patients.~   "
214972|NCT00745810|"~     Ischemia- reperfusion ( IR ) injuries were not only seen in the transplanted organs but also~     the remote organs such as lungs that brings major postoperative complications. Severe~     complications such as pulmonary infiltration and pulmonary edema following reperfusion were~     frequently associated with liver transplantation. Cardiac surgery performed with the use of~     cardiopulmonary bypass ( CPB ) provokes a systemic inflammatory response syndrome that~     affects postoperative pulmonary, myocardiac and renal functions. Previous study about the~     reperfusion injuries was focused on the leukocyte and endothelial activation and the~     following oxidative injuries, however, the alteration on pulmonary function such as dynamic~     compliance and the oxidative/antioxidative balance in erythrocytes and the following effects~     in CPB have not been fully studied. Erythrocytes' reaction to oxidative stress including~     cytoplasma and cell membrane should be studied because RBCs are the major circulating blood~     cells having different types of antioxidant system to capture reactive oxygen species ( ROS )~     thus RBC may be severely injured by ROS or protected ROS injuries during CPB. In these~     three-year study, we plan to explore the extent and pattern of remote oxidative injuries in~     lungs by massive ROS production and the following products released from reperfused organs.~     In the first year, the remote pulmonary injuries from hepatic IR will be focused. We plan to~     establish an animal model for pulmonary function and pulmonary injury assessments including~     dynamic compliance (Cdyn), pulmonary edema wet-to-dry ratio (W/D), malondialdehyde (MDA) and~     histopathological findings under hepatic IR challenge. In the second year, the IR effects~     during and after CPB on circulating blood cells will be fully studied. We plan to investigate~     the magnitude, subtypes and timing on ROS production, the changes of oxidative and~     antioxidant activities of erythrocytes including cytoplasma and cell membrane, the changes on~     leukocytes and plasma to explore the roles of circulating erythrocytes on oxidative stress in~     CPB. In the third year, we plan to try propofol, stated having antioxidant in vivo and in~     vitro, on the remote pulmonary injuries following hepatic IR and CPB.~   "
214973|NCT00745797|"~     1. Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy,~          were randomized to receive PCI (30 Gy/10fr) or no PCI.~        2. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .~        3. The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5%~          significance (60 events, 206 patients).~   "
214974|NCT00745784|"~     The purpose of the research is to learn more about the experience of grief in young bereaved~     spouses/partners. Recent research has shown that young bereaved spouses/partners experience~     grief uniquely from other age groups, but it is still unclear how certain factors affect the~     experience of grief. The investigators research team is interested in studying how the~     psychological factors of trauma, personality, and meaning of the loss affect grief reactions~     in young spouses/partners after the loss of a spouse to cancer.~   "
214975|NCT00745771|"~     Multiple-dose, double-blind, double-dummy, parallel, randomized, placebo and active~     controlled study of pharmacokinetics of Diractin® as well as safety and efficacy for muscle~     soreness from exercise.~   "
214976|NCT00745758|"~     Extensive research has shown that the big event that leads to the initiation of vasospasm is~     the release of oxyhemoglobin (blood breakdown product).Depletion of NO synthase (19,20,21)~     was also noted after SAH.CSF is produced from choroid plexus in the ventricle. If the SAH is~     too dense, the blood in the subarachnoid space will not easy to be washed out.~   "
214977|NCT00745745|"~     This clinical trial is a multi center, prospective, randomized, parallel study designed to~     compare septal to apical ICD lead placement.~   "
214980|NCT00745706|"~     Atrial Fibrillation (AF) is a common heart rhythm problem that can be eliminated by a~     radiofrequency ablation procedure. The purpose of this study is to assess the amount of AF~     that occurs before and after an ablation procedure associated with symptoms versus AF that is~     not associated with any symptoms. This study will confirm whether patients' symptoms or lack~     of symptoms post-ablation correlate well with actual episodes of Atrial Fibrillation. This is~     important information for physicians to know as it will help guide patient care post-ablation~     in the future. Information on patients' AF episodes will be collected by an implantable loop~     recorder (ILR) which will be implanted in all study patients 3 months prior to their AF~     ablation procedure. The ILR will automatically collect information on detected AF episodes~     while patients will records any symptoms related to AF episodes in study diaries.~   "
214981|NCT00745693|"~     The purpose of this study is to identify the role of endothelin 1 (a natural vasoconstrictor)~     in the adverse vascular effects demonstrated after exposure to air pollution~   "
214982|NCT00745680|"~     Left ventricular (LV) remodeling after acute myocardial infarction (AMI) has been well~     described in previous studies. However, there is a paucity of data on the incidence of and~     risk factors for LV remodeling in modern clinical practice that incorporates widespread use~     of acute reperfusion strategies and almost systematic use of antiremodeling medications,~     such as angiotensin-converting enzyme inhibitors and beta blockers. The recent improvements~     in AMI management do not abolish LV remodeling, which remains a relatively frequent event~     after an initial anterior wall AMI. As a leading cause of heart failure, postinfarction LV~     remodeling represents an important target for therapeutic interventions. Within the~     ventricular mass, size, shape, connections and orientation in a three-dimensional space of~     every single constituent determine its functional behavior. The complex architecture of the~     ventricular mass creates multiple inhomogeneities of electrical and mechanical loads at the~     cellular and the microscopic tissue level, that cause cardiac function to be 'stochastic in~     nature'. The myocardial infarction will altered the ventricular shape and functional~     inhomogeneities carrying the morphodynamic advantages such as impaired suction for diastole~     after diminishing recoil relaxation with decreased twisting strain in systole. The alteration~     in contractile mechanics interacts with the intraventricular fluid dynamic filed that~     influence the regional myocardial shearing stress. Altered LV transmural wall strains have~     been proposed to cause infarct extension and may have an important role in propagating LV~     remodeling.~   "
214983|NCT00745667|"~     This is a multicenter trial comparing laparoscopic correction of a perforated peptic ulcer~     with the open technique by upper laparotomy. Hypothesis is that after laparoscopic correction~     will be discharged 3 days sooner due to less postoperative pain and complications.~   "
214984|NCT00745654|"~     This is an investigation on the frequency of chronic pain amongst recipients after lung~     transplantation. Factors relating to the development of chronic pain are investigated.~   "
214985|NCT00745641|"~     The clinically widely used X-ray computed tomography examination has a low-grade radiation~     effect and recently has attracted much attention concerning the possible adverse effects of~     radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells~     mainly because it can interact with water (which makes up to 80% of cells) to generate~     reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we~     can reach, there is no report concerning the relation between X-ray computed tomography~     examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if~     the routinely applied abdominal X-ray computed tomography examination may induce a higher~     level of ROS in the peripheral blood.~      Study subjects will be patients who are admitted to our hospital because of abdominal~     diseases that need to receive abdominal X-ray computed tomography examination for diagnosis.~     In total, sixty cases will be enrolled for the study. The formal consent will be delivered~     and explained to the patients and families several hours before the performance of abdominal~     X-ray computed tomography. The formal consent will be retrieved and then the peripheral blood~     will be sampled just before the performance of computed tomography.ROS level in the sampled~     peripheral blood, before and after the performance of abdominal X-ray computed tomography,~     will be measured, compared, and analyzed. Totally 120 blood samples, including 60 samples~     just before and 60 samples 2 hours after the performance of computed tomography, will be~     collected from 60 study subjects within 5 months (August 10 ~ December 30, 2008). Reactive~     oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system~     (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).~   "
214986|NCT00745628|"~     Construction of coronary heart disease cohort of more than 10000 patients in China.~     Investigation on current situation of secondary prevention of CHD will be carried out and the~     effect of physician training and patient education will be evaluated.~   "
214987|NCT00745615|"~     This is a multinational, multicenter, randomized, double-blind, parallel-group active~     extension of LAQ/5062 study (NCT2004-003943-28), assessing the tolerability, safety and~     efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered, in subjects~     with relapsing remitting multiple sclerosis (RRMS), followed by an open-label phase of~     laquinimod 0.6 mg daily.~      Study LAQ/5063 consists of two periods:~        -  The first period of the extension study is an active, double-blind period. Participants~          from the active treatment arms in LAQ/5062 continue their assigned treatment in blinded~          fashion. Participants who were assigned to placebo treatment in LAQ/5062 are equally~          randomized in blinded-fashion to laquinimod 0.6 mg or laquinimod 0.3 mg~        -  Once Termination visit of LAQ/5063 active double-blind phase (completion of the full 36~          weeks or as requested by the Sponsor) is performed, all participants continue on~          laquinimod 0.6 mg daily as an open-label intervention. The open-label period continues~          as long as the Sponsor continues the development of laquinimod 0.6 mg for RRMS or early~          discontinuation.~   "
214988|NCT00745602|"~     The proposed research will investigate whether the irregular effects of atrial fibrillation~     on the body's circulation directly impacts the regulation of cerebral blood flow. To further~     delineate this finding, investigation of these potential effects will include differences in~     postural positioning. This data will be used to further understand the overall hemodynamic~     effects of atrial fibrillation on extra-cardiac organs of the body.~   "
214989|NCT00745589|"~     To test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as~     effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression~     of cardiovascular calcification.~   "
214991|NCT00745563|"~     A couple that does not achieve pregnancy though regular attempts for a year are defined~     infertile couple. This condition is caused by faulty functioning of the reproduction system~     of the husband or wife or both. If there are no organic defects and there is no definite~     injury to the reproductive system (ova or spermatozoa), the specialist doctor generally~     decides to put the couple into a fertility treatment program. Artificial insemination is one~     of the important ways of achieving pregnancy.~      Three common methods of artificial insemination:~        1. Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa~          in an appropriate liquid solution (Cup insemination, CI) upon the cervix.~        2. Spermatozoa injection (after improvement) through the vagina to the cervix~          (Intra-Cervical Insemination, ICI).~        3. Spermatozoa injection (after improvement) directly into the uterus (IUI-Intra-Uterine~          Insemination).~      The EVIE - Slow Release Insemination method:~      The slow release insemination is utilizing a Grasby type MS16 pump for 3 hours. The release~     rate for motile spermatozoa is 50X103 per minute.~      Advantages:~        -  Very close approximation of the natural procedure in which the spermatozoa arrive to the~          fertilization site over a long period.~        -  An extended window of opportunities for meeting between the ovum and spermatozoa will~          be longer.~        -  There is no loss of spermatozoa due to leaking as sometimes happens with single-time~          injection practiced in the IUI method.~      Primary Endpoint:~      Accumulation of 50 cycles of SRI- slow release insemination (study group) in addition to 50~     cycles of regular IUI (control group). Two weeks after insemination Beta hCG test~      Secondary Endpoints:~      Four weeks after insemination - US Viability scan~      Procedure:~      Subjects will be women with fertility difficulties who are designated for IUI treatment. 100~     insemination cycles will be conducted. (50 regular IUI and 50 EVIE-SRI). Subjects that were~     treated with the IUI method and who does not become pregnant will then be treated with the~     EVIE-Slow Release method and vice versa.~   "
214992|NCT00745550|"~     The study consists of two phases: The first portion of the study is a Phase 1 dose escalation~     study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when~     given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis~     (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase~     2 study to define the efficacy and safety profile of single agent SB1518 at the recommended~     dose in subjects with CIMF.~   "
214993|NCT00745537|"~     Postpartum depression (PPD) is depression that occurs shortly after the mother delivers her~     baby. Mothers with postpartum depression may feel sad mood, low motivation or stress; some~     may have problems caring for their new baby. Successful depression treatment involves early~     screening and detection of postpartum depression and early access to treatment services.~      The purpose of this study is to evaluate the effectiveness of a telephone-based depression~     screening and care management program for postpartum women. We will evaluate the: 1) how~     often (frequency) young mothers develop symptoms of depression 4 to 6 weeks after birth, 2)~     how quickly (timeliness) young mother receive treatment and how effective (adequacy) are the~     treatments for the symptoms of postpartum depression, 3) the effects of depression care~     support on young mothers' symptoms and their ability to function at 3, 6 and 12 months after~     entering the study, 4) visits to the pediatrician or nurse practitioner (preventive health~     services) during their baby's first year of life, and 5) cost and cost savings associated~     with depression care management.~   "
214994|NCT00745524|"~     This study aims to investigate the prevalence of ADHD and other psychopathology, and current~     function and life quality among several high risk populations of imprisoned adults and~     adolescents who receive special resources in school or dropout from school.~   "
214995|NCT00745511|"~     This is s randomized, multi-center, double blind, 3 arm, phase I/II pilot study to evaluate~     the safety and efficacy of treatment with ORA102 combined with Avastin (Bevacizumab) versus~     Avastin alone, in patients with neo-vascular age related macular degeneration (AMD).~   "
214996|NCT00745498|"~     The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab~     injection on postoperative vitreous hemorrhage after diabetic vitrectomy.~   "
214997|NCT00745485|"~     1. The study will assess the safety and tolerability of a single-infusion of zoledronic~          acid 5 mg administered in a private medical practice setting by a nurse provided by a~          nationwide infusion service. Safety data will largely be monitored by investigating~          changes in the patients' well-being during the study.~        2. The study will pilot and test a Patient Registry and Infusion Service process, which~          will allow zoledronic acid to be administered to trial patients in the investigators'~          private rooms by a team of roving nurses.~   "
214998|NCT00745472|"~     Monitoring of auditory evoked potentials (AEP) in patients during general anaesthesia is~     commonly used to ensure a sufficient hypnotic level during surgery. The amplitude of AEP~     (AEPa) has in clinical settings been found to correlate to pain. The aim of the study was to~     test, if AEPa could detect increasing experimental pain stimulations in healthy volunteers.~     Electric nerve stimulation, cold and heat pain were used as pain models.~   "
214999|NCT00745459|"~     Patients who require gastric endoscopy, including the patient population* excluded from the~     phase III controlled clinical study of NPO-11, will receive an intragastric single dose of~     NPO-11 20 mL. The efficacy of NPO-11 as a premedication for endoscopy will be evaluated based~     on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and~     the end of endoscopy (primary outcome measure).~      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and seven days after administration.~      Patient population excluded from the phase III controlled clinical study of NPO-11~        -  Patients with reflux esophagitis~        -  Patients with active gastric or duodenal ulcers~        -  Patients who undergo endoscopy under sedation~        -  Patients who undergo endoscopy with a scope of <9 mm in diameter~   "
215000|NCT00745446|"~     The purpose of this study is to determine whether a retrofit particle trap can reduce the~     adverse vascular responses to diesel exhaust inhalation~   "
215001|NCT00745433|"~     This study is conducted in Europe. The aim of this observational study is to investigate the~     efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding~     repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical~     practice~   "
215002|NCT00745420|"~     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease~     that can cause organ damage, stroke, and intense pain episodes. A blood stem cell transplant~     is a treatment option for someone with a severe form of the disease. Prior to undergoing a~     transplant, people typically receive a conditioning regimen of high doses of chemotherapy and~     other medications to prepare the body to accept the transplant. A conditioning regimen that~     uses lower doses of chemotherapy and medications may be safer for transplant recipients. This~     study will evaluate the safety and effectiveness of blood stem cell transplants, using bone~     marrow from unrelated donors, in children with severe SCD who receive a reduced intensity~     conditioning regimen prior to the transplant.~   "
215003|NCT00745407|"~     Fenofibrate increases adiponectin levels, but reduces leptin levels~   "
215004|NCT00745394|"~     Non-invasive assessment of blood flow to organs has long challenged clinicians. Recently,~     near infrared spectroscopy (NIRS) has been recognized as a methodology that may achieve this~     goal. A commercially available NIRS monitor, marketed by Somanetics, Inc., is now in~     widespread use in the clinical care of pediatric cardiac patients in the operating room and~     in the intensive care unit post-operatively. When a patch/probe from the monitor is placed on~     the forehead or lower back, blood oxygen concentration data is obtained which has been found~     to correlate with actual blood samples taken by IV. The presence of this NIRS data would give~     the surgeon important feedback about blood flow to important areas like the brain and kidneys~     during heart surgeries on children and after the operation is completed in the intensive care~     unit.~      The investigator wishes to perform a prospective study of the NIRS monitor use with children~     that need heart surgeries that require heart-lung bypass and sometimes require monitoring in~     the ICU, post-operatively.~   "
215005|NCT00745381|"~     The purpose of this study is to establish a neuroendocrine tumor registry. A registry is a~     collection of information. To create this registry, the investigators would like to get~     information, blood and tumor samples from people with neuroendocrine tumors. By collecting~     this information and material, the investigators are hoping to learn more about the genetic~     causes of neuroendocrine tumors. All of this will help us to better understand neuroendocrine~     cancer, so the investigators can find better ways to treat and diagnose this disease. DNA~     will be taken from the blood samples and will be used in future studies. This will be an~     important resource from which the investigators can study genes that may be related to a~     higher risk of neuroendocrine tumors.~      The information collected will include medical information, family history of cancer and your~     answers to questions about how the cancer affects quality of life.~   "
215006|NCT00745368|"~     The purpose of this research study is to determine how much raltegravir gets into the male~     and female genital tract.~   "
215007|NCT00745355|"~     The purpose of this study is to learn about the quality of life of people living with bladder~     cancer. We are interested in learning about how the treatments for bladder cancer affect~     people. We plan to use the findings from this study to help doctors provide better care and~     information to patients with bladder cancer.~   "
215008|NCT00745342|"~     This 2-year randomized, controlled trial examined the impact of a clinic-based, family~     teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.~   "
215009|NCT00745329|"~     Background: The treatment of inflammatory bowel diseases (IBD) is based mainly on 3~     compounds: 1- 5 aminosalysilates . 2- immunomodulators (Azathioprines). 3- Biologic therapies~     (Infliximab, Adalimumab) . There are no established data in the literature whether these~     therapies effects sperm quality. Given that a large number of the patients are young men in~     the reproductive stage of their lives , It of importance to investigate these effect.~      Aim: To investigate the effect of chronic treatment of any of the three therapy mentioned~     above, on sperm quality .~   "
215010|NCT00745316|"~     The main purpose of this study is to determine the safety and tolerability of tonapofylline~     (BG9928) when given at different doses to patients with heart failure and renal~     insufficiency.~      This study will also explore:~        -  Disease related quality-of-life~        -  Exercise capacity~        -  Renal function~        -  Concomitant medications~   "
215011|NCT00745303|"~     Since Tai Chi Chuan (TCC) training has been shown to be beneficial to the cardiopulmonary~     function of the subject, TCC might have a beneficial effect on the pulmonary function,~     autonomic nervous modulation, lipid profile, and cytokines production in the aged subjects.~   "
215012|NCT00745290|"~     The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine~     HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.~   "
215013|NCT00745277|"~     1. Briefly describe the purpose of this protocol:~             -  The purpose of this study is to see how low dose vs. high dose of the study drug,~               carbidopa, effect movement in subjects with Parkinson's disease. The low dose of~               the study drug is 75 mg and the high dose is 450mg.~        2. Briefly describe the procedures subjects will undergo:~             -  Subjects will take part in 2 screening visits one week apart to determine~               eligibility. Subjects will be randomly chosen to start either high or low dose~               carbidopa and take it for 4 weeks. Subjects will be called 2, 4, and 6 or 7 days~               after this visit to ask how they are doing after starting this dose of study drug.~               The investigators will leave subjects a message if the investigators cannot reach~               them. If there are any problems, the investigators will schedule them to come to~               the clinic within the next 2 days.~             -  Subjects will have an outpatient visit 2 weeks after screening and a hospital~               admission 2 weeks after that. At the hospital, subjects will stay for 3 days. They~               will have blood drawn and their Parkinson's disease assessed by a finger tapping~               exercise, timing their walking, and looking at their uncontrolled movements.~             -  The subject will then receive the opposite dose of carbidopa for 4 weeks. Subjects~               will be called 2, 4, and 6 or 7 days after this visit to ask how they are doing~               after starting this dose of study drug. The investigators will leave them a message~               if we cannot reach them. If there are any problems, the investigators will schedule~               them to come to the clinic within the next 2 days.~             -  The outpatient visit and hospital admission will repeat again. At the end of the~               second hospital admission, treatment on the study is over and subjects will go back~               to their original Parkinson's disease medications. The study will end with a follow~               up phone call or clinic visit 2 - 4 weeks after the final hospital admission.~        3. If applicable, briefly describe survey/interview instruments used.~             -  Subjects will fill out a daily diary that asks about their movement throughout the~               day for 3 days before they come to the Oregon Clinical and Translational Research~               Institute.~        4. Briefly describe how the data will be analyzed to address the purpose of the protocol.~             -  Finger tapping rates will be compared between high and low dose study drug use to~               see if one group has slower rates than the other.~   "
215014|NCT00745264|"~     -  Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg~          applied on 2 major joints to~        -  400 mg ketoprofen from Diractin® (100 mg applied to 4 joints - overexposure)~        -  100 mg and 400 mg ketoprofen from Diractin® used concomitant with heat application~        -  100 mg and 400 mg ketoprofen from Diractin® used concomitant with moderate exercise~   "
215015|NCT00745251|"~     The primary objectives of this study are to evaluate the safety and efficacy of VI-0521~     compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and~     to assess the relative contributions of weight loss on parameters of OSA in these subjects.~   "
215029|NCT00745056|"~     This is a prospective, observational study of the cohort of older post-menopausal~     participants in the WHI Memory Study, a sub-cohort of participants in the WHI Hormone Trials.~     Annual cognitive assessments and ascertainment of cognitive impairment enable the continued~     monitoring of long-term effects of randomization to HT on cognition and identification of~     predictors of cognitive vulnerability and resilience in older women.~   "
215056|NCT00744692|"~     The primary objective is to determine the feasibility of attaining acceptable rates of donor~     cell engraftment (>25% donor chimerism at 180 days) following reduced intensity conditioning~     (RIC) regimens in pediatric patients < 21 years receiving cord blood transplantation for~     non-malignant disorders.~   "
231622|NCT00524615|"~     The purpose of this study is to evaluate the efficacy of spironolactone on lowering blood~     pressure when added to therapy in patients with resistant arterial hypertension.~   "
215016|NCT00745238|"~     Background: Myotonic dystrophy lead to highly heterogeneous, multisystemic symptoms including~     myotonia, progressive muscle weakness, cardiac conduction defects, cataract, metabolic~     dysfunction, and excessive daytime somnolence. This last symptom is related to respiratory~     failure and/or to involvement of the central nervous system. However the metabolic~     disturbances could contribute to it. From the respiratory point of view this disease is~     characterised by the progressive appearance of respiratory failure of muscular origin but~     mainly associated with a defect in the central respiratory drive. The treatment for this~     hypoventilation is non-invasive ventilation (NIV).~      It is not currently absolutely clear as to the best choice of criteria to judge long term~     effectiveness of NIV. The most usual criteria are normalisation of daytime blood gases,~     diminution of respiratory work, improvement in daytime symptoms and improvement in sleep~     structure. Other criteria are currently little studied, for instance the contribution of the~     interaction between alveolar hypoventilation and oxygen desaturation during the night and~     biological deficiencies such as systemic inflammation, glucose intolerance or insulin~     resistance. Likewise there is little information about the interaction between alveolar~     hypoventilation and endothelial dysfunction and arterial stiffness both being accurate~     predictive factors for cardiovascular risks.~      Aim: to evaluate the impact of NIV on endothelial dysfunction in patients with myotonic~     dystrophy. The secondary objectives are to assess the impact of NIV on systemic inflammation,~     arterial stiffness, insulin-resistance, quality of sleep, and daytime vigilance in these~     patients.~      Methods: Patients with chronic alveolar hypoventilation already treated by long term NIV will~     be included. They will have an initial check-up (Visit 1), then will interrupt NIV treatment~     for four weeks (Visit 2), and then return to NIV treatment. The last check-up will be done~     four weeks after NIV resumption (Visit3).~      Expected results: It is expected that NIV withdrawal will results in a deterioration of~     cardio-vascular parameters (endothelial function and arterial stiffness), metabolic~     parameters (insulin-resistance and systemic inflammation), quality of sleep and daytime~     vigilance. Return to NIV treatment may show an improvement of these parameters with a basal~     state recovery.~   "
215017|NCT00745225|"~     To study whether peroxisome proliferator-activated receptor-gamma activation in peritoneal~     dialysis patients will reduce inflammation, atherosclerosis, calcification and improve~     survival of peritoneal dialysis patients~   "
215018|NCT00745212|"~     The venous thromboembolism is one of the first causes of maternal mortality. Until 2003, only~     a few recommendations were available on the optimal use of antithrombotic therapy as a~     preventive measure against thromboembolism in pregnant women. In this study, we propose :~        1. To gather the experts who took part in the French consensus conference and the local~          experts to create a score in accordance with the national and international consensus~          and to give some precise therapeutic strategies.~        2. To evaluate the discriminant, feasible and useful character of this new score by a~          prospective multicentric study including 2000 pregnant women with a risk of~          thromboembolism or placental vascular pathology who will benefit from therapeutic~          strategies defined by the new score.~   "
215019|NCT00745199|"~     Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent~     information suggests that interactions between dermal mast cells and distal ends of~     nonmyelinated C fibers may be important in the precipitation and regulation of the sensory~     stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma~     histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a~     mast cell stabilizing agent that inhibits degranulation of mast cells and the release of~     histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may~     attenuate uremic pruritus by decreasing serum tryptase level.~   "
215020|NCT00745186|"~     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic~     bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy~     volunteers.~   "
215021|NCT00745173|"~     The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution,~     breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet~     when administered together with multiple doses of Premarin (conjugated estrogens or CE) to~     healthy postmenopausal women.~      Information will also be obtained regarding the safety and tolerability of this combination~     in healthy, postmenopausal women.~   "
215022|NCT00745160|"~     The purpose of this study is to determine if collecting information and blood from a group of~     people who never smoked but who have lung cancer, is possible across the US. The~     investigators will collect information on each patient's diagnosis and treatments. If the~     collection is successful, blood samples will be used to try to identify new genes (which are~     the basic elements of heredity, passed from parents to their offspring), which may explain~     and predict why certain patients develop lung cancer without having smoked tobacco.~   "
215023|NCT00745147|"~     The purpose of the study is to compare the therapeutic efficacy, safety, cost-effectiveness~     and maintenance effect between Chinese herbal formula and lactulose on chronic constipation~     in long-term care.~   "
215024|NCT00745134|"~     The goal of this clinical research study is to learn if combining a curcumin preparation with~     standard radiation therapy and chemotherapy (capecitabine) can help to shrink or slow the~     growth of rectal cancer. The safety of this combination and whether curcumin can help to~     decrease some of the side effects of standard radiotherapy and chemotherapy will also be~     studied.~   "
215025|NCT00745121|"~     The overall objective of the study is to compare treatment with the ATRA TECH Implant System,~     OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic~     osteoporosis. The hypothesis is that there will be no difference in marginal bone level~     alterations between the two groups.~   "
215026|NCT00745108|"~     Tibolone has been registered for the treatment of climacteric symptoms and for the prevention~     of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial~     safety of tibolone in comparison with CE/MPA.~   "
215027|NCT00745095|"~     The annual incidence of colorectal cancer in the US during 2005 was approximately 150,000~     cases and this neoplasm claimed 56,000 lives (American Cancer Society). Detection (and~     removal) of colonic polyps is now the central strategy in reducing the risk of colon cancer.~     Thus, failure to detect and remove small cancers and polyps can have dire consequences.~     Although it has not been shown that persons with spinal cord injury (SCI) have an increased~     risk of this disease, there is no reason to assume that the incidence after SCI would be less~     than that of the general population.~      Colonoscopy would appear to be a better approach to colon cancer screening after SCI but may~     also be unreliable if bowel evacuation is unsatisfactory for complete large bowel~     visualization. Poor colonoscopic visualization is a major concern in persons with SCI because~     they have long-standing difficulty with evacuation (DWE) and might not respond in a~     predictable or satisfactory manner to the conventional bowel preparations used for~     colonoscopy. Furthermore, to the extent that bowel preparation for colonoscopy is~     unsatisfactory in persons with SCI, the putative benefits of colonoscopy in reducing colon~     cancer mortality may not be realized.~      In the absence of effective regimens for bowel preparation in persons with SCI, we suspect~     that the documented benefits of screening colonoscopy in the able-bodied may not generalize~     to persons with SCI. Regardless, these observations support the need for improved bowel~     preparation approaches in persons with SCI. One such approach might involve the adjunctive~     administration of prokinetic drugs to standard practices. A prokinetic agent that might be~     beneficial in this context is neostigmine, an anticholinesterase inhibitor with prominent~     parasympathomimetic actions (stimulation of peristalsis) on the colon. We have studied~     neostigmine extensively in persons with SCI and have shown that, when given in combination~     with glycopyrrolate, this approach to stimulate bowel evacuation is safe and effective for~     bowel evacuation.~   "
243852|NCT00362414|"~     The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients~     with acute ischemic stroke.~   "
215030|NCT00745043|"~     Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These~     are very common conditions and many patients have both diseases. Beta-blocker drugs are~     extensively used in the treatment of angina, high blood pressure and after heart attacks to~     decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness~     and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in~     COPD patients as they may make the breathlessness worse, but it has now been established that~     they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the~     body and the investigators do not know if they can work together or if they would cancel each~     other out. The investigators also do not know which of the different types of beta-blockers~     now available are better for COPD patients. This study will investigate what happens to the~     airways of people taking both of these drugs.~   "
215031|NCT00745030|"~     Parkinson's disease (PD) is the second most common neurodegenerative disorder of the elderly~     that affects a million patients in US. Sleep dysfunction impacts up to 90% of PD patients. PD~     patients experience a variety of sleep disorders including parasomnias, specifically REM~     behavior disorder (RBD) that can precede the onset of motor manifestations of PD. RBD has~     negative consequences on patients' and their bed partners' quality of life mainly due to its~     impact on the sleep quality and day time alertness. RBD also predisposes affected individuals~     and their bed partners to physical injuries.~      There are no FDA approved treatments for RBD. Clonazepam is the most commonly used treatment~     but carries risks of daytime sedation, tolerance, and withdrawal symptoms. More recently,~     melatonin has been demonstrated to be effective in several small studies. Ramelteon, a~     selective melatonin receptor agonist with favorable safety profile, could potentially be~     effective for the treatment of RBD.~      This pilot protocol will investigate safety and efficacy of ramelteon for the treatment of~     RBD in subjects with parkinsonism. We plan to recruit 20 subjects with RBD diagnosed based on~     the clinical interview and confirmed by the polysomnographic (PSG) data. The study is~     designed as a prospective randomized placebo controlled 12-week study. Primary outcome~     measure will be change in frequency of RBD events based on the daily sleep diaries. Secondary~     outcome measure will be change in the amount of tonic muscle activity based on the results of~     the baseline and final PSG. A number of other secondary and exploratory outcome measures will~     be collected~   "
215032|NCT00745017|"~     Depression affects over one million people in Canada, resulting in $14.4 billion per year in~     costs to Canadian society. In order to prevent this often lifelong disorder, it is critically~     important to identify risk factors for the recurrence of depression. A crucial force in~     maintaining depression is the generation of stressful life events. That is, individuals who~     have a history of depression are likely to generate the very events that precipitate future~     depressive episodes (e.g., relationship break-up, fired from job, conflicts with the law) due~     to negative personality characteristics and disrupted social support networks resulting from~     previous episodes. This project is the first to test a model that examines the role of~     negative personality, low social support, and childhood abuse and neglect as risk factors for~     the generation of stressful life events that predict future depression. We will test this~     model in a group of patients meeting formal criteria for depression who will be treated and~     then followed up for 12 months or until depression recurrence. With this long-term design we~     will be in a unique position to understand how depression is maintained over time, thus~     suggesting important treatment strategies to prevent depression recurrence.~   "
215033|NCT00745004|"~     Irritable bowel syndrome is a common condition affecting 1 in 10 of the population. About a~     third of these suffer from diarrhoea, which severely impairs their quality of life. Previous~     studies in Nottingham have suggested that some patients with diarrhoea may have an excess of~     a chemical called serotonin in their gut. Serotonin stimulates secretion and propulsion in~     the gut and contributes to diarrhoea. We are interested to see whether a drug, Ondansetron,~     which blocks the effect of serotonin, would improve symptoms in patients with IBS and~     diarrhoea. We think the drug may work better in people with a specific gene type so your~     genetic makeup may be of influence and we would like to test this. Because IBS symptoms~     fluctuate, one way to determine whether Ondansetron is effective is to perform a randomised~     placebo controlled trial in which neither the patient nor the doctor knows which medication~     is being taken in each part of the study.~   "
215034|NCT00744991|"~     The purpose of the study is to determine the efficacy and safety of enzastaurin in patients~     with CTCL who failed prior therapies.~   "
215035|NCT00744978|"~     1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure~          of cognition in patients with mild to moderate Alzheimer's disease~        2. Evaluate the effects of varenicline on clinically relevant measures including attention~          and executive function, behavior, and clinician rated global change.~        3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients~          with mild to moderate Alzheimer's disease~        4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate~          Alzheimer's disease.~   "
215036|NCT00744965|"~     This is a randomized prospective trial which addresses the question of whether use of an oral~     hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will~     result in achieving euglycemia in a shorter period of time and, in turn, result in less~     frequent maternal and neonatal morbidities. This study is designed to test the hypothesis~     that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling~     lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling~     alone.~   "
215037|NCT00744952|"~     Assessing disease activity in people with Takayasu's arteritis is difficult, as most people~     with the disease do not exhibit visible, measurable symptoms. Combination positron emission~     tomography/computed axial tomography (PET/CT) is a particularly sensitive, accurate scanning~     method that may improve researchers' ability to evaluate people with the disease. This study~     will determine the effectiveness of PET/CT in assessing disease activity in people with~     Takayasu's arteritis.~   "
215038|NCT00744939|"~     Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist~     injection. Subjects will be screened within 48 hours of previously scheduled MRI, those~     meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post~     MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls~     conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.~   "
215039|NCT00744926|"~     This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared~     to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and~     exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once~     weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)~     or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide~     10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once~     weekly). The anticipated time on study treatment is 1 year, and the target sample size is~     100-500 individuals.~   "
215040|NCT00744913|"~     The overall objective of this study is to assess the effectiveness of NRT (Nicoderm patches)~     plus counselling treatment in women in the second and third trimester of pregnancy.~   "
215041|NCT00744900|"~     NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease~     management. Neurosurgery is not indicated in the majority of cases because of presence of~     several lesions in the brain, failure of primary tumor control or presence of extra-cerebral~     metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of~     these patients in this situation is based on supportive care and whole-brain radiotherapy.~     The place of chemotherapy for patients with good performance status was discussed for a long~     time and it is now admitted. However, the place of new drugs such as pemetrexed, which is~     currently used as a second line treatment for NSCLC, needs to be further studied. It is known~     that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar~     effectiveness when compared to other drugs associations commonly used in this indication. In~     addition, Cisplatin with Pemetrexed probably present a better safety profile.~      The present study is based upon the hypothesis stipulating that the association~     cisplatin-pemetrexed will be at least as efficient as the others association currently used~     for treatment of NSCLC and will present a better safety profile. The primary objective of~     this study is overall response rate on brain metastasis according to RECIST criteria.~     Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus~     pemetrexed, safety profile, quality of life, neurological symptoms, overall survival.~      The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II~     study with the possibility of stopping the study early because of lack of efficacy.~   "
215042|NCT00744887|"~     The objectives are to determine the effect of different ritonavir doses on darunavir (DRV)~     oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish~     an optimal ritonavir boosting dose for DRV and to evaluate short-term safety and~     tolerability.~   "
215043|NCT00744874|"~     The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency~     of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal~     atrial fibrillation. (PAF)~   "
215044|NCT00744861|"~     The purpose of this study is to determine whether using active low intensity pulsed~     ultrasound as adjunct therapy following single level posterior instrumented lumbar surgery~     increases the posterolateral success rate when compared to inactive (placebo) therapy.~   "
215045|NCT00744848|"~     Effective postoperative pain control to promote improved healing, faster patient~     mobilization, shortened hospital stays, and reduced healthcare costs.~   "
215046|NCT00744835|"~     This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the~     safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative~     treatment of symptomatic permanent atrial fibrillation.~   "
215047|NCT00744822|"~     This study is a prospective, multi-center study. 50 lung transplant recipients will be~     enrolled in the study. Subjects will be selected from lung transplant recipients, who have~     undergone single or double lung transplantation during the last six months These patients~     will undergo a baseline VRI recording prior to the interventional procedure and a follow-up~     VRI at 1 hour after the interventional procedure. Furthermore, the patients will be recorded~     at the designated follow-up periods of 1, 3 and 6-month (+ 7 days) post-baseline visit, as~     well as before and 1 hour after any recurrent interventional procedure~   "
215048|NCT00744809|"~     This is a study to evaluate the effect of TMC278 25 mg daily on the QT/QTc interval (heart~     conduction and heart rhythm) in healthy volunteers. In a separate panel of healthy~     volunteers, the effect of efavirenz (EFV) 600 mg daily on the QT/QTc interval will be~     evaluated.~   "
215049|NCT00744796|"~     The purpose of this study is to report the early clinical outcomes in patients undergoing~     Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) for corneal edema secondary~     to corneal endothelial cell dysfunction, and to correlate this clinical data with the latest~     generation of imaging modalities available for the anterior segment.~   "
215050|NCT00744770|"~     The purpose of this Phase I, open-label, single-sequence drug-drug interaction trial in~     patients on stable methadone maintenance therapy is to investigate the potential interaction~     between TMC278 25 mg daily and methadone, at steady-state.~   "
215051|NCT00744757|"~     The purpose of this study is to evaluate the response rate of decitabine in previously~     treated and untreated Taiwanese participants with Myelodysplastic Syndrome (MDS - a disease~     associated with decreased production of blood cells, blood cells are produced but do not~     mature normally).~   "
215052|NCT00744744|"~     RATIONALE: Gathering information about quality of life in patients with cancer may improve~     the ability to plan treatment and may help patients live more comfortably.~      PURPOSE: This clinical trial is studying health-related quality of life in patients with~     bladder cancer.~   "
215053|NCT00744731|"~     The purpose of this study is to obtain long-term safety and tolerability information on~     carisbamate as add-on therapy for the treatment of partial onset seizures in patients with~     epilepsy. Seizure counts will be obtained to measure the rate of seizures for each patient~     during the study.~   "
215054|NCT00744718|"~     This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients~     with platin resistant ovarian cancer.~   "
215055|NCT00744705|"~     The normal range of retinal nerve fiber layer thickness might be different between Asians and~     Caucasians. However, the recently developed imaging device such as the Cirrus HD OCT includes~     only the Caucasian data. So, the investigators want to find its normal range of in Asians.~   "
215057|NCT00744679|"~     The primary objective is to assess the pharmacokinetic (PK) profile of natalizumab (Tysabri)~     at steady state.~      The secondary objective is to assess the pharmacodynamics (PD) profile (α4 integrin~     saturation) of Tysabri at steady state.~   "
215058|NCT00744666|"~     Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various~     vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA~     develop ocular hypertension after the drug is injected into the eye. Similar to IVTA,~     topically administered corticosteroids eye drops result in ocular hypertension in~     approximately 33% of the population. It is unknown whether identifying patients who develop~     ocular hypertension from topical corticosteroids could be used to identify patients who are~     at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy~     of topical prednisolone 1% four times daily for one month as a screening test to reduce the~     incidence and severity of ocular hypertension after IVTA injection.~   "
215059|NCT00744653|"~     By applying short electric pulses to cells, the cell membranes can become permeabilised~     (electroporation). This can be used augment the effect of chemotherapy, by providing direct~     access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several~     hundred fold, enabling once-only treatment. We wish to offer electrochemotherapy to breast~     cancer patients suffering from chest wall recurrences that are ulcerated or painful and where~     other treatments have failed.~   "
215060|NCT00744640|"~     Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic~     cancer (APC). Recent randomized trials have shown increased clinical benefit with the~     addition of oxaliplatin and prolonged median survival with the addition of capecitabine to~     gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer~     drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding~     and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in~     patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy~     of this triple combination.~   "
215061|NCT00744627|"~     The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily~     (QD), in adults with Generalized Anxiety Disorders.~   "
215062|NCT00744614|"~     The purpose of this study is to evaluate the use of Capnography (Continuous recording of the~     carbon dioxide content of expired air)as an alternative test to measure PC02 levels in~     patients with asthma, chronic obstructive pulmonary (COPD,interstitial lung disease(ILD)or~     coronary disease who are at risk of intubation.~   "
215063|NCT00744601|"~     The purpose of this study is to assess neurocognitive and associated neural regions/circuitry~     disruptions relevant to impulsive relapse in cocaine-addicted subjects, and the relationship~     of the cognitive and neural mechanisms of impulsivity/decision-making to relapse style.~   "
215064|NCT00744588|"~     This proposal is part of the INIA Stress Consortium. This study will~        1. explore the contributions of lifetime trauma, recent stress, and alcohol use on~          stress-hormone axis disruption in treatment seeking, one-month abstinent,~          alcohol-dependent subjects~        2. assess the combined contributions of stress-hormone axis disruption and episodic stress~          on the risk of prospective drinking following treatment~        3. determine the role of neurosteroids in alcohol use.~   "
215065|NCT00744575|"~     The purpose of this study is whether patients suffering from chronic back pain for more than~     one year will show a specific neurophysiological pattern in the EEG. This pattern is referred~     to as Thalamo-Cortical Dysrhythmia (TCD) and consists most likely of a self sustaining loop~     between the Cortex and Thalamus. This pattern has been found before in patients with very~     severe chronic pain. Specific lesions to the Thalamus result in a reduction of this pattern~     and decrease in pain. With this study the investigators will assess whether this pattern can~     be found in back pain patients of different types. Patients will be measured by EEG for the~     existence of TCD and will undergo detailed pain and psychological diagnostic.~   "
215066|NCT00744562|"~     This is an open-label Phase 1 dose escalation study of OMP-21M18 in subjects with previously~     treated solid tumors for which there is no remaining standard curative therapy and no therapy~     with a demonstrated survival benefit. Up to 30 subjects will be enrolled at up to 4 centers.~     Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and~     efficacy. No formal interim analyses will be performed. Prior to enrollment, subjects will~     undergo screening to determine study eligibility. Upon enrollment, subjects will receive~     weekly intravenous (IV) infusions of OMP-21M18 for 9 weeks. After 9 weeks of treatment,~     subjects will be assessed for disease status. If there is no evidence of disease progression~     or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-21M18~     every other week until disease progression.~      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). The dose~     levels of OMP 21M18 will be 0.5, 1.0, 2.5, 5, and 10 mg/kg administered IV weekly for 9~     doses. No dose escalation or reduction will be allowed within a dose cohort. The dose may be~     administered at any time during the day. Three subjects will be treated at each dose level if~     no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experience a DLT, that~     dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further~     subjects will be dosed at that level and 3 additional subjects will be added to the preceding~     dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be~     assessed for DLTs from the time of the first dose through 7 days after administration of the~     4th dose, but prior to administration of the 5th dose (i.e., Days 0-28). Dose escalation, if~     appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT~     assessment.~   "
215067|NCT00744549|"~     The purpose of this study is to determine whether antioxidants (vitamin E, selenium and~     lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by~     MRI imaging among men on Active Surveillance.~   "
215068|NCT00744536|"~     Angiogenesis increases in higher risk MDS patients and those with proliferative CMML.~     Angiogenesis is associated with increased risk of leukemic transformation and poorer~     prognoses. Low dose chemotherapy may have anti-angiogenic properties by targetting the~     genetically stable endothelial cells. Lenalidomide has been recently shown to be highly~     effective as monotherapy in low/low-intermediate risk MDS, particularly in the subgroup~     harboring a 5q- deletion. Lenalidomide has not been well studied in higher risk MDS although~     there are some reports of lenalidomide's efficacy in RAEB-T and AML. One potential mode of~     action of lenalidomide is inhibition of angiogenesis. The investigators hypothesize that by~     combining lenalidomide with low dose melphalan in higher risk MDS the investigators will more~     effectively block angiogenesis and achieve responses or hematologic improvement in MDS.~   "
215069|NCT00744523|"~     The objective of the ARMOUR study is to evaluate the safety and effectiveness of the Mo.Ma~     proximal flow blockage cerebral protection device for patients at high surgical risk for~     carotid endarterectomy who undergo carotid artery stenting~   "
215084|NCT00744315|"~     Human Vascular Endothelial Grown Factor 165 (hVEGF165) administration is promising therapy~     induces a new vessels, arterioles and capillaries in regions whose revascularization surgery~     is not possible by direct or by percutaneous angioplasty. This study aims to evaluate the~     clinical effects and safety of gene therapy with hVEGF165 in patients with advanced coronary~     artery disease.~   "
215070|NCT00744510|"~     Polycystic Ovary Syndrome (PCOS) is very common, affecting approximately 5% of women of~     reproductive age, and impacts not only on quality of life, but also has long-term health~     consequences for many sufferers, such as increased risks of developing Type II diabetes,~     cardiovascular disease and cancer of the womb. The symptoms that may occur such as irregular~     periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to~     poor self-esteem. Whilst treatments can help fertility, other treatments to correct the other~     symptoms are less successful. Alternative methods to regulate periods would be helpful,~     especially ones which avoid the long-term use of steroids in patients who may already be~     overweight. Reflexology is poorly represented in scientific papers, with nothing published~     regarding reflexology and its effect upon PCOS. However patients who use reflexology report~     more regular periods, thicker hair on scalp and greater wellbeing. Therefore we aim to~     investigate the effect of reflexology on:~        1. The menstruation cycle (normal being every 21-35 days).~        2. Imbalances in hormone, insulin and blood sugar levels associated with PCOS.~        3. Other problems associated with PCOS such as thinning hair on scalp, excessive body hair,~          and obesity.~        4. Quality of life. Government and NHS agendas agree that if there's evidence of an~          effective complimentary therapy the NHS should provide it. Therefore the results may~          have an influence on the care pathways of patients with PCOS towards a more holistic,~          patient centred and empowered approach. It is also non invasive and liable to result in~          higher patient satisfaction regarding their treatment. This research may also inform~          policy makers so that complementary medicine provision is provided on a wider basis~          within the NHS, which at the moment is dictated by the individual Trust's budget~          allocation. However this research could save money overall as in America, the yearly~          cost of treating PCOS is $4.36 billion.~   "
215071|NCT00744497|"~     The purpose of this study is to determine whether survival can be prolonged in patients with~     castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.~   "
215072|NCT00744484|"~     The purpose of this study is to determine whether water based or land based group training is~     more effective for people with COPD.~   "
215073|NCT00744471|"~     The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in~     osteoarthritis of the hip in patients~   "
215074|NCT00744458|"~     The purpose of this study is to determine the efficacy of three different interventions to~     improve treatment adherence among patients with arterial hypertension or diabetes in rural~     Cameroon.~   "
215075|NCT00744445|"~     The purpose of this research study was to determine if the activity of erythropoietin~     (r-HuEPO) is time dependent when given to chronic renal failure patients at three different~     times of day.~   "
215076|NCT00744419|"~     The purpose of this study is to determine how the body uses and eliminates pantoprazole, a~     drug used to treat GERD. This is a pharmacokinetic (PK) study. PK is a measure of how much~     drug is in the blood and how long it takes to leave the body. It is hypothesized that younger~     infants will need a lower dose than older children to achieve the same PK measurement.~      The results of this study will be used to determine the best dose of the drug to use in each~     age group. Pantoprazole is a drug used to decrease acid production. The use of pantoprazole~     has not been approved for use in children. Pantoprazole is approved for use of acid-related~     and stomach disorders in adults.~   "
215077|NCT00744406|"~     Depression affects over one million people in Canada, resulting in $14.4 billion per year in~     costs to Canadian society. In order to prevent this often lifelong disorder, it is critically~     important to identify risk factors for the recurrence of depression. A crucial force in~     maintaining depression is the generation of stressful life events. That is, individuals who~     have a history of depression are likely to generate the very events that precipitate future~     depressive episodes (e.g., relationship break-up, fired from job, conflicts with the law) due~     to negative personality characteristics and disrupted social support networks resulting from~     previous episodes. This project is the first to test a model that examines the role of~     negative personality, low social support, and childhood abuse and neglect as risk factors for~     the generation of stressful life events that predict future depression. We will test this~     model in a group of patients meeting formal criteria for depression who will be treated and~     then followed up for 12 months or until depression recurrence. With this long-term design we~     will be in a unique position to understand how depression is maintained over time, thus~     suggesting important treatment strategies to prevent depression recurrence.~   "
215078|NCT00744393|"~     The purpose of this study is to determine what effect sodium oxybate has on the functions of~     sleep in mechanically ventilated, critically ill patients hospitalized in an intensive care~     unit.~   "
215079|NCT00744380|"~     The purpose of this randomized, double-blind study is to evaluate the utility, safety, and~     cost of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical~     intensive care unit (ICU) patients requiring sedation when tracheal extubation is nearing.~     Fifty medical or surgical ICU patients requiring sedation with existing benzodiazepine~     therapy and qualifying for daily awakenings will be randomized in a double-blind manner to~     receive additional midazolam or dexmedetomidine.~   "
215080|NCT00744367|"~     This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by~     HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus~     pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to~     one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after~     4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable~     metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be~     switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of~     taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the~     target sample size is 100-500 individuals.~   "
215081|NCT00744354|"~     RATIONALE: Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Bortezomib may also stop the growth of multiple myeloma~     by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin~     hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving doxorubicin hydrochloride~     liposome together with vorinostat and bortezomib may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and to~     see how well it works when given together with bortezomib and doxorubicin hydrochloride~     liposome in treating patients with relapsed or refractory multiple myeloma.~   "
215082|NCT00744341|"~     The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart~     failure patients with renal dysfunction.~   "
215083|NCT00744328|"~     The purpose of this study is to determine whether estrogen patches are effective for the~     treatment of postpartum major depression, as compared to sertraline (Zoloft) and placebo.~   "
215085|NCT00744302|"~     A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L~     (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism,~     secondary hyperparathyroidism and cardiovascular calcification in prevalent haemodialysis~     patients. And the long term safety of the 1.25 mmol/L calcium dialysate was also considered.~      There are two phases of study for each subject. Phase 1 (screening phase). During this phase,~     each potential subject will be evaluated to determine if he/she is eligible for the study.~      Phase 2 (intervention phase). Each subject will be randomly allocated to physiological~     calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium~     dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36~     months.~   "
215086|NCT00744289|"~     Aims:~      This prospective trial seeks to investigate the efficacy of a financial incentive in~     increasing the uptake and completion of the HBV vaccine series among people who inject drugs~     (PWID). Using a randomised controlled trial design, the investigators will offer the 3 dose,~     accelerated HBV schedule to eligible PWID allocated to either a standard of care or incentive~     condition. Participants allocated to the incentive condition will receive a small incentive~     payment after the second and third dose of the vaccine. It is hypothesized that the~     proportion of participants who complete the vaccine series in the incentive payment arm will~     be higher compared to the non-incentive payment arm (standard of care).~   "
215087|NCT00744276|"~     The purpose of this study is to determine the safety of three doses of topically applied~     danazol compared to placebo in subjects with pain associated with fibrocystic breast disease~     and to determine the appropriate clinical dose for future studies.~   "
215088|NCT00744263|"~     The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate~     vaccine in the prevention of the first episode of vaccine-type pneumococcal~     community-acquired pneumonia in adults.~   "
215089|NCT00744250|"~     The purpose of this research study is to learn about the activity of oral Pancrecarb® (a~     pancreatic enzyme preparation which contains proteins that help to digest food), administered~     by mouth as a capsule filled with specially coated granules in patients taking exogenous~     pancreatic enzyme therapy. Specific enzymes activities will be determined from samples of~     stomach and intestinal fluids after a standard liquid meal.~   "
215090|NCT00744237|"~     This study will evaluate the effects of nebivolol on glycemic control compared with~     metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus~   "
215091|NCT00744224|"~     The purpose of this study is to explore whether the GLP-1 receptor agonist exenatide, may~     prevent glucocorticoid-induced glucometabolic abnormalities and beta-cell dysfunction in~     healthy subjects.~   "
215092|NCT00744211|"~     A robust release of endothelin-1-1 (ET) with subsequent ETA subtype receptor (ET-AR)~     activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass~     (CPB). Increased ET-AR activation has been identified in patients with poor left ventricular~     (LV) function (reduced ejection fraction; EF). Accordingly, this study tested the hypothesis~     that a selective ET-AR antagonist (ET-ARA) administered peri-operatively would favorably~     affect post-CPB hemodynamic profiles in patients with a pre-existing poor LVEF.~   "
215093|NCT00744198|"~     The treatment of urinary stress incontinence with trans-obturator approach, know as~     transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and~     safety of this minimally invasive surgery have been demonstrated, also in comparison with~     similar procedures, i.e transvaginal tape (TVT).~      To date the results of TOT in terms of efficacy and safety described in literature mainly~     refer to procedure in which synthetic materials are used, whereas few data regarding the use~     of biological materials are available. Moreover, despite the well known benefits of the~     available synthetic and eterologue kit, their use may be limited by the high cost of these~     materials. At this proposal it can be suggested as alternative option the possibility to~     perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable~     introductory needles. Based on these considerations the aim of this trial will be to compare~     autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.~   "
215094|NCT00744185|"~     The investigators observed that Propranolol, a beta-blocker commonly used in children was~     efficient to control the growth of alarming hemangiomas of the face.~      The primary objective of this study is to determine the efficiency of 1 month-early treatment~     of propranolol in infants aged less than 4 months affected by an hemangioma without any~     consequences on vital or functional structure and not justifying corticosteroids.~      The secondary objectives are:~        -  the kinetic of the hemangioma evolution in infants treated by propranolol~        -  Observance~        -  Safety~   "
215095|NCT00744172|"~     The purpose of this study is to analyze prospectively all hysterectomies performed in Finland~     for benign indications including all 46 public hospitals performing hysterectomies and also 7~     private clinics. Hypothesis is that vaginal and laparoscopic hysterectomies are safe and~     cost-effective methods of hysterectomy.~   "
215096|NCT00744159|"~     This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer~     surgery compared to open colon surgery.~   "
215097|NCT00744146|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     immunogenicity of Protexia, an experimental drug being developed to protect soldiers against~     the effects of nerve agents.~      Volunteers will be entered into one of five groups. Four of the groups will receive a single~     intramuscular dose of Protexia or saline placebo on Study Day 1 and will participate in the~     study for approximately 71 days. One of the groups will receive two intramuscular doses of~     Protexia or saline placebo - one dose on Study Day 1 and the second dose on Study Day 72.~     This group will participate in the study for approximately 142 days.~      All volunteers will remain at the study site as an inpatient for three days after they are~     dosed and will be monitored closely by the study doctors and staff. After that, volunteers~     will return to the study site as outpatients at predetermined intervals. Groups 1, 2, 4, 5~     will have a total of 6 follow-up visits and Group 3 will have a total of 12 follow-up visits.~      It is expected that this study will provide important information on the safety and~     tolerabiity of Protexia at one and two doses.~   "
215117|NCT00743886|"~     To evaluate the influence of Plasma Rich in Growth Factors (PRGF) on the healing process of~     medial collateral ligament (MCL) tear.~   "
215118|NCT00743873|"~     To check the influence of injected platelet-rich plasma (PRP) on the healing of medial~     retinaculum and the redaction in recurrent dislocation of the patella.~   "
215098|NCT00744133|"~     The purpose of this study is to determine how many infected mosquito bites are required to~     reliably give volunteers a case of malaria. It is expected that volunteers will develop~     malaria and may have symptoms. Safety is the main concern. A malaria challenge is given by~     allowing a volunteer to receive 1, 3, or 5 mosquito's bites. Then participants are carefully~     followed and blood is tested. The study will also look at how immune systems (the cells and~     substances that protect the body from infection and foreign matter) respond after mosquito~     bite challenges. About 38 subjects (aged 18-40 years) from the greater Baltimore, Maryland~     (United States) community will participate and may stay overnight for 10 days at a local~     medical center. Procedures include medical screening, assignment to a dose group, a mosquito~     bite challenge, and 56 day follow-up. Volunteers will be contacted by telephone at 6 and 12~     months after the malaria challenge.~   "
215099|NCT00744120|"~     This follow-up protocol is designed to evaluate participants who have previously been~     lymphoma patients treated on approved clinical studies of the National Institutes of Health.~   "
215100|NCT00744107|"~     To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable~     Coronary Stent System for the treatment of de novo and restenotic (previously unstented)~     lesions in native coronary arteries in subjects with coronary artery disease (CAD) having a~     reference vessel diameter (RVD) between 2.5 - 4.0 mm and a lesion length ≤ 26 mm amenable to~     percutaneous coronary intervention (PCI) with a single stent in subjects with symptomatic~     ischemic heart disease.~   "
215101|NCT00744094|"~     In the present study the investigators aim to determine whether protein supplementation can~     augment the response to a 12 week resistance training program in healthy elderly men.~   "
215102|NCT00744081|"~     The purpose of this study is to show superiority in complete responses of combination therapy~     MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control~     which was treated with MTC alone.~   "
215103|NCT00744068|"~     The overall objective of this research is to develop and refine empirically supported~     continuing care interventions that promote healthy behavior and sustained abstinence from~     illicit drug use.~   "
215104|NCT00744055|"~     Prazosin is an alpha-1 adrenergic receptor antagonist that has been used successfully in the~     treatment of trauma nightmares and sleep disturbance in combat veterans with PTSD, and~     alcohol dependence.~      The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in~     reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and~     PTSD.~   "
215105|NCT00744042|"~     This clinical trial studies the safety and efficacy of asfotase alfa in infants and young~     children with infantile onset HPP.~   "
215106|NCT00744029|"~     In patients with acute stroke, systemic thrombolysis needs to be administered within three~     hours of symptom onset. The aim of the present study was to reduce prehospital delays in a~     population-based intervention.The intervention consisted of an educational letter indicating~     stroke symptoms and emphasizing the importance of calling the emergency medical services~     (EMS). The investigators additionally included a bookmark and sticker with the EMS telephone~     number. A total of 75,720 inhabitants received the intervention. Between 2004 and 2005, 741~     patients with cerebrovascular events were admitted from the control areas (n=24) and 647 from~     the intervention areas (n=24).~   "
215107|NCT00744016|"~     The purpose of this study is to compare the maintenance of mild to moderate ulcerative~     colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day~     versus placebo.~   "
215108|NCT00744003|"~     Trauma continues to be the major killer of young Americans, mainly due to hemorrhage or brain~     injury. In trauma centers, up to a quarter of these severely injured patients arrive with a~     coagulopathy and thereby experience an increased risk of death, despite the current standard~     of medical and surgical management. The PI for this grant proposal is a fellowship-trained~     trauma surgeon who works full-time at Grady Memorial Hospital (GMH), the only Level I Trauma~     Center in Atlanta. It is only one of four Level 1 trauma centers for the entire state of~     Georgia. This research is a direct extension of the retrospective research the PI has~     previously published. Her retrospective research discovered a previously undescribed form of~     coagulopathy, early trauma induced coagulopathy (ETIC), which cannot be explained by present~     paradigms. Two civilian trauma articles as well as military data from the Iraq war have~     substantiated the occurrence of ETIC, but no prospective literature has defined it or its~     kinetics. More importantly, the results from these studies represent a new paradigm shift, in~     which ETIC appears to be a primary dysfunction which is independently associated with death.~     Therefore, its early identification and correction is crucial for our mechanistic~     understanding, and ultimately, our choice of interventions and improved survival. GMH is a~     high-volume trauma center that sees patients with a variety of injury mechanisms, and,~     therefore, is the perfect setting to confirm ETIC. First, the project will confirm the~     prevalence of ETIC with an observational prospective cohort of injured patients. Data on the~     coagulation system and risk factors, both known and suspected, of all patients will be~     collected upon patient arrival as well as patient outcome with all identifying information~     protected. This is the first prospective research project that will allow simultaneous~     control of confounders associated with outcome and thereby scientifically validate the~     occurrence of ETIC. One unique component of our data collection is a focus on the timing of~     events as they relate to the development and consequences of coagulopathy, to account for the~     dynamic process. At the completion of data collection, a matched cohort of ETIC and non-ETIC~     blood samples will be tested for coagulation factors to provide insight into ETIC's~     pathophysiology. In the short term, our conclusions will assist us in our approach to~     resuscitation of the bleeding trauma patient as some trauma centers have already started to~     change protocols based on our present incomplete understanding of trauma-induced~     coagulopathy. In addition, the coagulation system data collected in this study will lead to~     pathophysiological answers and to more refined hypotheses for future research at a~     coagulation system level. Ultimately an understanding of ETIC will lead to a more effective,~     tailored treatment. Our main study hypothesis is that post-trauma coagulopathy is a primary~     dysfunction that occurs early after a traumatic event in up to 25% of all trauma patients~     triaged to Trauma Center care.~   "
215109|NCT00743990|"~     This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub®~     (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for~     control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as~     rated by both parents and children.~   "
215110|NCT00743977|"~     The present study aims at comparing the pharmacokinetics of the original formulation of~     phenazopyridine and a same generic product.~   "
215111|NCT00743964|"~     Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed~     promising results in randomized clinical trials for advanced gastric cancer (AGC). The~     objective of the study is to evaluate the safety and activity of ECX and CX combination~     chemotherapy given as first-line therapy for AGC.~   "
215112|NCT00743951|"~     Ministries of Health consider wait lists for total joint replacement a top priority. Research~     priorities to manage wait lists indicate the need to establish benchmarks that consider~     patient preferences. However, patients' preferences for hip or knee replacements are strongly~     associated with their misperceptions of the indicators for, and the risks and benefits of,~     these procedures. These misperceptions can be corrected with the use of patient decision~     aids. When decision aids are used in combination with assessing surgical eligibility, there~     may be a reduction in unnecessary referrals for surgery either because the patient is~     ineligible or because the eligible candidates make informed decisions to forgo this option.~      The study objective is to pilot test the feasibility of a trial evaluating the effects of~     patient decision aids on reducing unnecessary surgical referrals for total joint replacement,~     when used in combination with a general practitioner run clinic to screen patients with hip~     or knee osteoarthritis for surgical eligibility.~      The investigators expect to provide evidence of feasibility (e.g. ease of recruiting~     patients, delivering the interventions, measuring patient outcomes) and sample size needed~     for a larger scale study. This study should also provide evidence for planning implementation~     of the interventions and standardized training across other centers.~   "
215113|NCT00743938|"~     The purpose of this study is to improve disease control and survival for patients who were~     treated with chemotherapy using BMS-690514 over erlotinib~   "
215114|NCT00743925|"~     The objective of this study is to evaluate the safety and efficacy of A 002 when added to~     high dose atorvastatin in subjects with an acute coronary syndrome (ACS)~   "
215115|NCT00743912|"~     The primary objective of this study is to determine if rifaximin, administered daily has an~     effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the~     pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.~   "
215116|NCT00743899|"~     The aim of this study was to compare conservative versus aggressive strategy in patients with~     intermediate lesions with angiography guidance alone.~   "
215120|NCT00743847|"~     The primary objective of this protocol is to assess the efficacy of two dose strengths of~     varenicline (0.5 mg BID and 1mg BID) as adjunctive treatment for cognitive impairment in~     symptomatically stable outpatient schizophrenic subjects who are receiving treatment with~     atypical antipsychotic medications.~      A secondary objective is to evaluate the safety and tolerability of two doses of varenicline~     in symptomatically stable schizophrenic subjects who are receiving treatment with atypical~     antipsychotic medications.~   "
215121|NCT00743834|"~     This study will test the hypotheses that: 1. 12 weeks of Luvox-CR plus web-based~     Cognitive-Behavioral Therapy (CBT) [CT-STEPS] will produce greater symptom relief of OCD than~     treatment with Luvox-CR alone; and, 2. subjects receiving 12 weeks of CT-STEPS added to~     Luvox-CR treatment after 12-weeks of Luvox-CR monotherapy will experience greater OCD symptom~     relief (from weeks 12-24) than those continuing Luvox-CR treatment and having access to~     CT-STEPS from week one. 3. subjects who begin CT-STEPS at week 12 will be more likely to~     complete it than those who begin CT-STEPS at baseline.~   "
215122|NCT00743821|"~     The purpose of this study is to validate and refine a diagnostic device that can detect~     attention and memory deficits that result from mild traumatic brain injury (mTBI).~   "
215123|NCT00743808|"~     Twelve health organizations from around the US were selected to participate in a chart review~     Hypertension and Diabetes Initiative with the goal of improving blood pressure control in~     persons with diabetes.~      Hypothesis:~      A three-phase quality improvement initiative facilitated and monitored through the~     International Diabetes Center (IDC) will result in improved population-mean systolic blood~     pressure in the aggregate data pool of patients from all 12 participating sites at~     geographically distinct health systems.~   "
215124|NCT00743795|"~     The purpose of this study is to compare the safety, tolerability and effectiveness of the~     experimental drug GS-9190 when administered for 24 or 48 weeks with peginterferon alfa 2a and~     ribavirin for the treatment of genotype-1 chronic hepatitis C infection.~   "
215125|NCT00743782|"~     This study will evaluate the safety, biological activity, and pharmacokinetics of PTH~     delivered by subcutaneous injection compared with an infusion pump. We anticipate pump~     delivery of PTH will be more physiologic because it mimics normal parathyroid gland secretion~     of PTH. We expect that pump delivery will simultaneously normalize blood and urine calcium,~     phosphorus and magnesium levels with minimal or no fluctuations throughout the day. Pump~     therapy will require lower PTH doses and should normalize markers of bone turnover. We expect~     the improved metabolic control during pump therapy will be especially evident in patients~     with more severe forms of hypoparathyrodism where there is an unmet need for improved~     therapy.~   "
215126|NCT00743769|"~     The purpose of this study is to determine whether the intravenous administration of single-~     and multiple-ascending doses of Thymosin Beta 4 is safe and tolerable in healthy volunteers.~   "
215127|NCT00743756|"~     The purpose of this study is to assess the impact of home-delivered Medical Nutrition Therapy~     on clinical outcomes for persons with diabetes. The primary outcomes of this studies include~     A1c (A1C), blood glucose, blood pressure, Body Mass Index, lipid levels and other measures of~     disease progression and management as well as costs of medical care provided throughout the~     intervention period.~   "
215128|NCT00743743|"~     Objective: To determine the effects of resveratrol extract given in a 215 mg dose in a daily~     supplement currently available over the counter, on cognitive and global functioning in~     patients with mild to moderate AD on standard therapy.~   "
215129|NCT00743730|"~     The purpose of this study is to compare, the safety, efficacy and level of parent and nurse~     satisfaction with three methods of opioid administration post-operatively in children (4-18~     years of age) with developmental delay.~   "
215130|NCT00743717|"~     The aim of this study is to provide evidence that the safety and effectiveness of the ceramic~     femoral component of the Gem Total Knee System is similar to FDA approved implants used in~     total knee replacement surgery. The hypotheses to be tested are that the investigational and~     control groups are equivalent in terms of patient success rate and complication-free rate.~   "
215131|NCT00743704|"~     The primary objective of this pilot study is to establish a model of neutrophil airway~     inflammation for future testing of anti-inflammatory substances in an early stage of clinical~     development. Moreover, the suitability of an electronic nose for early detection and~     diagnosis of airway inflammation will be determined.~   "
215132|NCT00743691|"~     The purpose of the study is to determine whether community based management of infections~     with antibiotics administered by health extension workers reduce all cause mortality in~     neonates after the first day of life compared to current MOH IMNCI model of referral to~     hospital~   "
215133|NCT00743678|"~     An innovative therapeutic strategy to increase the complete resection rate is of utmost~     importance in order to enhance survival in colorectal cancer patients with unresectable~     liver-only metastasis. Therefore, the investigators propose a prospective study of~     neoadjuvant chemotherapy using FOLFOX6 plus cetuximab to convert initially unresectable liver~     metastasis to potentially resectable disease.~   "
215134|NCT00743665|"~     The primary aim of this study is to characterize the quality of life of youth with Cyclic~     Vomiting Syndrome (CVS) as well as the strategies they use to cope with stress, their~     strengths and vulnerabilities, and to assess symptoms of depression and anxiety in these at~     risk youth. The impact of CVS on the child's parent and family will also be assessed.~      A second aim is to evaluate the associations among coping strategies, personal strengths and~     vulnerabilities and the frequency and intensity of CVS attacks to determine if particular~     coping styles and personal characteristics are associated illness severity, psychiatric~     co-morbidity and quality of life~   "
215135|NCT00743652|"~     This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal~     conjugate vaccine in Alaskan Native Children.~   "
215136|NCT00743639|"~     This study describes a controlled randomized clinical trial to evaluate the efficacy of bone~     marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy~     and cardiac failure class III or NYHA.~   "
215137|NCT00743626|"~     The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone~     or in combination or associated with a Pap smear, will demonstrate greater specificity for~     clinically significant precancerous disease than will a Pap smear alone and that these tests~     will be of comparable or superior sensitivity than the Pap smear.~   "
215138|NCT00743613|"~     Erectile dysfunction is a common complaint and is found frequently in men with~     hyperlipidemia, hypertension, diabetes and those who smoke. ED may also be an early warning~     of peripheral arterial disease. This study is designed to look for a relationship between the~     degree of ED and the presence of PAD when associated with co-morbid conditions.~   "
215139|NCT00743600|"~     This study will use healthy volunteers and patients with shoulder problems (pain or impaired~     movement). Ultrasound will be used to image and document the appearance of both normal and~     abnormal shoulder structures.~   "
215140|NCT00743587|"~     The purpose of this study is to determine if the measurement of pressure pain thresholds, in~     patients suffering osteoarthritis of the thumb, can be used to assess the activity of~     potential analgesic agents after a single dose. The study will use agents known to give pain~     relief in osteoarthritis as positive controls. These agents are: tramadol, naproxen and~     oxycodone.~   "
215141|NCT00743574|"~     The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium~     (Ca) supplementation in overweight (BMI > 27) premenopausal women diagnosed with Polycystic~     Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient~     in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels < 20 ng/mL).~   "
215142|NCT00743561|"~     The purpose of this study is to determine whether ambulatory polygraphy during a short~     hospitalization in a neurology unit has the same performance than inpatient polysomnography,~     the actual gold standard, in the diagnosis of sleep apnea in patients suffering from multiple~     system atrophy (MSA).~   "
215143|NCT00743548|"~     The study's purpose is to find an easy and effective alternative to dental floss for those~     persons who cannot or choose not to dental floss so that they can maintain and/or achieve~     optimal oral health. The study hypothesis is that the inter-dental brush is as effective as~     dental floss for removing plaque from between the teeth and for reducing bleeding gums in~     persons with gingivitis, but may be easier to use and thus encourage daily home use.~   "
215144|NCT00743535|"~     The incidence of anterior pelvic defect in women is estimated about 10% and it may be often~     associated to urinary stress incontinence. To date the correction of anterior defects with~     the use of graft material inserted with transobturator approach has become of large use.~     Moreover, given the frequent association of urinary stress incontinence to anterior defect,~     in most of cases it becomes necessary to perform at the same time an anti-incontinence~     procedure, i.e. a sub-urethral sling positioning. Based on these considerations the aim of~     this trial will be to compare two different approach for sub-urethral sling positioning,~     transobturator and transvaginal tape (TOT and TVT) performed in association to transobturator~     correction of anterior defect with mesh in terms of efficacy and safety.~   "
215145|NCT00743522|"~     Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be~     painful to the patient and repetitive shocks can decrease a patient's quality of life.~     Previous studies have suggested that one or more sets of aggressive device parameter settings~     may reduce the total number of shocks in primary prevention patients. In addition to shock~     therapies, antitachycardia pacing (ATP) is also available in ICDs to treat VT. The PROVIDE~     trial aims to prospectively study the effect of high detection rates, prolonged detection~     intervals, aggressive SVT discriminators, and extensive ATP therapy in prolonging the time to~     first shock in primary prevention patients.~   "
215146|NCT00743509|"~     The purpose of this Phase II study will assess the effectiveness of the combination of oral~     cyclophosphamide and sirolimus in sarcoma patients with relapsed or widespread disease who~     cannot be cured by surgery, radiation or conventional chemotherapy.~   "
215147|NCT00743496|"~     Relapsed and/or refractory neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma are~     considered difficult to treat and cure. For this study we are testing the use of a new~     experimental (investigational) antibody called hu14.18K322A. GD2 is expressed on the surface~     of most of these tumor types.~      Two schedules of hu14.18K322A antibody will be evaluated in this study, (1) daily for four~     consecutive days schedule every 28 days and (2) once weekly for 4 weeks schedule every 28~     days. Approximately 25-40 participants will be required to define the maximum tolerated dose~     for each schedule. Participants will continue on treatment for a maximum of 4 to 8 courses or~     until one or more of the criteria for off-treatment are met.~   "
215148|NCT00743483|"~     The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and~     pancreatic insufficiency following treatment with BSSL~   "
215149|NCT00743470|"~     The purpose of this study is to study the safety, tolerability and pharmacokinetics of~     rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.~   "
215150|NCT00743457|"~     The purpose of the study is to determine whether an ultrasound of the eye can be used as a~     radiation-free alternative to X-ray to identify children with risk of shunt failure in the~     Emergency Department. Please note that a shunt is an artificial or natural channel running~     between two other channels.2. Briefly summarize how participants are recruited.~   "
215151|NCT00743444|"~     The purpose of the study is to compare frequency and content of reflux episodes in patients~     with gastroesophageal reflux disease.~   "
215152|NCT00743431|"~     The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with~     advanced ovarian cancer, focusing on infusion reactions and palmar-plantar~     erythrodysesthesia.~   "
215153|NCT00743418|"~     The research is aimed at exploring the application of novel tracking technique for the study~     of spatial activity among dementia patients and its implication on their families. The study~     sample will be composed of three groups of volunteers, each including100 participants aged~     over 60 years. The first group will include MCI (Mild Cognitive Impairment) patients. The~     second group will include patients that suffer from mild dementia. The third group will~     include age matched healthy participants. The tracking equipment will be a GPS apparatus of~     450 gms that will be carried by the participants for 24 hours along 2-4 weeks. The GPS data~     will be transferred via the cellular network to operator center at the Hebrew university at~     Jerusalem, and will be documented in assigned data files. This monitoring procedure will be~     held every year and along a period of five years. The impact of the patient behavior on the~     care giver will be studied by means of five interviews along the tracking period.~   "
215242|NCT00742248|"~     The purpose of this study is to demonstrate equivalent efficacy between two different~     formulations of formoterol (pMDI using HFA-134 propellant and dry powder) on lung function in~     adult patients with partially reversible COPD.~   "
215154|NCT00743405|"~     This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics~     of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized,~     placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and~     female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of~     10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits~     are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a~     randomized sequence on 5 separate study occasions.~   "
215155|NCT00743392|"~     The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year~     old women who report having used internet dating websites in the past year.~   "
215156|NCT00743379|"~     The purpose of this study is to determine if TH-302, in combination with A) Gemcitabine, or~     B) Docetaxel or C) Pemetrexed methotrexate, are safe and effective in the treatment of~     Pancreatic Cancer, Castrate-resistant Prostate Cancer, and Non-small Cell Lung Cancer,~     respectively.~   "
215157|NCT00743366|"~     The objective of this study is to investigate the interaction between marijuana and~     quetiapine, with the goal of using this information to improve marijuana treatment outcome.~   "
215158|NCT00743353|"~     The purpose of this research study is to get information from volunteers without cancer and~     patients with cancer who have received a new investigational study agent called, [F-18]~     RGDK5, to evaluate biodistribution and dosimetry for the study agent and determine F-18~     RGD-K5 uptake in angiogenic tumor. the system.~   "
215159|NCT00743340|"~     The primary objectives of this trial are to provide FTC-203 study participants in South~     Africa with continued access to the study drug, emtricitabine (FTC), following completion of~     the FTC-203 study and to collect long-term safety information in participants receiving~     emtricitabine in combination with other antiretroviral agents.~   "
215160|NCT00743327|"~     The purpose of this study is to examine the link between low testosterone and insulin~     resistance/diabetes in men undergoing androgen deprivation therapy for prostate cancer. The~     study will also evaluate other cardiovascular risk factors in these men.~   "
215161|NCT00743314|"~     RATIONALE: Diagnostic procedures, such as single-photon emission computed tomography and~     computed tomography lymphoscintigraphy, may help lower the dose of radiation therapy after~     surgery, and help prevent lymphedema.~      PURPOSE: This clinical trial is studying single-photon emission computed tomography and~     computed tomography lymphoscintigraphy followed by intensity-modulated radiation therapy to~     see how well they work in treating patients who have undergone surgery for stage I or stage~     II breast cancer.~   "
215162|NCT00743301|"~     The aim of this study is to compare the effects of a diet rich in palm olein, a fraction of~     palm oil, to a diet rich in olive oil and a diet rich in Danish lard on plasma total-, LDL~     and HDL cholesterol as well as triacylglycerol (TAG), fasting insulin and glucose, C reactive~     protein and plasminogen activator inhibitor 1 in healthy men. The investigators hypothesis is~     that palm olein and olive oil will have the same effect on plasma total cholesterol, LDL- and~     HDL concentration and maybe also on the secondary outcome parameters that are related to~     cardiovascular disease risk. This may be caused by the differences in the sn-positioning of~     palmitic acid in palm olein. This difference may cause the palmitic acid in palm olein to be~     more prone to soap formations and excretion than palmitic acid from other sources, e.g. lard.~      This study is a double blinded, randomized, controlled 3 x 3 week crossover intervention~     study, without washout periods. The participants receive the three test foods in random~     order, decided by draw of lots. Blood samples are drawn in duplicate (on two following days)~     before and after each dietary period.~   "
215163|NCT00743288|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving melphalan together with panobinostat may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan when~     given together with panobinostat in treating patients with recurrent multiple myeloma.~   "
215164|NCT00743275|"~     To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009~     formulation.~      To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion~     influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human~     Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.~   "
215165|NCT00743262|"~     The purpose of this study is to investigate the performance of a new voice prosthesis in~     comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized~     patients. Factors taken into account are clinician and patient satisfaction with the~     insertion system, patient satisfaction with voice, speech, performance, and maintenance.~     Voice and speech will also be evaluated for the different prostheses by means of perceptual~     evaluations and acoustic analysis.~   "
215166|NCT00743249|"~     The purpose of this study was to determine the safety and retention times of two different~     lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up~     to three months in subjects with or without dry eye.~   "
215167|NCT00743236|"~     RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold~     ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether~     warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage I~     kidney cancer.~      PURPOSE: This randomized phase III trial is studying warm ischemia to see how well it works~     compared with cold ischemia during surgery in treating patients with stage I kidney cancer.~   "
215168|NCT00743223|"~     The aim of this study was to verify the frequency of the forward head posture in subjects~     with temporomandibular disorder and to compare them with control group~   "
215169|NCT00743210|"~     The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks~     provided in mid-pregnancy to obese subjects will decrease the plasma ADMA/L-arginine ratio,~     lower maternal blood pressure, improve endothelial-dependent vascular function and peripheral~     vascular stiffness, and improve uterine artery Doppler resistance and flow.~   "
215291|NCT00741611|"~     This is a randomized controlled study of the Bard High Density Mesh Ablation System for~     treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh~     Ablation System is as safe as and more effective than anti-arrhythmic drugs.~   "
215170|NCT00743197|"~     The purpose of this study is to compare the effectiveness of standard medical therapy versus~     usual care in women with chest pain, coronary endothelial dysfunction and unblocked coronary~     arteries.~      Coronary endothelial dysfunction (CED) is a condition in which the layers of cells around the~     heart do not function properly and is believed to be key factor in the development of~     atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased~     risk for future cardiovascular events, such as heart attack and stroke.~      A coronary angiogram allows physicians to see if any of the arteries in the heart are~     blocked, usually by fatty plaque. In many instances, angiograms in women experiencing chest~     pain do not show evidence of coronary disease (free of significant plaque build-up).~     Currently, there is no standard of care treatment plan for patients with normal coronary~     arteries, despite symptoms of chest pain, and as a result these patients may not receive~     medical treatment. However, these women often return to their physicians more than once with~     chest pain and go through a similar battery of tests.~   "
215171|NCT00743184|"~     This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the~     efficacy of ozarelix compared to placebo in the treatment of lower urinary tract symptoms~     (LUTS) secondary to benign prostatic hyperplasia (BPH) in men as assessed by the~     International Prostate Symptom Score (IPSS) at Week 14.~   "
215172|NCT00743171|"~     Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung~     function) of lung transplant recipients~   "
215173|NCT00743158|"~     This study aims to determine whether respiratory system transfer impedance (Ztr) may fill an~     important clinical function by providing a reproducible, valid, and sensitive measure of~     airway obstruction in people with CF.~   "
215174|NCT00743145|"~     The purpose of this study is to determine how naltrexone shifts the marijuana-response curve,~     a single, low-dose of naltrexone (12 mg/70 kg) or placebo will be administered 45 minutes~     before smoking marijuana (0,2,4,6,puffs of 6.2% THC). Naltrexone (12 mg/70 kg) or placebo~     will be administered 45 minutes before smoking to assess how opioid receptor blockade affects~     marijuana's subjective and physiologic effects. It is predicted that increasing the number of~     puffs of active marijuana will increase positive subjective ratings of marijuana and~     naltrexone and further increase these ratings.~   "
215175|NCT00743132|"~     ARF is a frequent event after hepatic resection and therefore clinically highly relevant.~      There is limited evidence on the incidence of postoperative ARF and its clinical relevance in~     patients undergoing liver resection.~      This study will evaluate the incidence of acute renal failure (ARF) after liver resection and~     its impact on postoperative mortality.~   "
215176|NCT00743119|"~     The following study is designed to determine the analgesic efficacy of smoked marijuana (0,~     1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a~     laboratory model of pain which has predictive validity for clinical use of analgesics. Oral~     THC (dronabinol) is known to have a slower onset and longer duration of action compared with~     smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and~     last longer than effects produced by smoked marijuana.~   "
215177|NCT00743106|"~     This trial will study the effects of fenoldopam on renal function in patients who have a~     single kidney undergoing surgery to remove part of that kidney secondary to renal cell~     carcinoma. The investigators will monitor and evaluate throughout the perioperative course~     the kidney function. Normally kidney function is predicted to show a worsening followed by an~     improvement after surgery.~      The investigators want to specifically identify if the use of fenoldopam lessens the injury~     to the kidney with this surgery.~   "
215178|NCT00743093|"~     The objective of this study is to monitor liver function tests (blood levels of an indicator~     of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen~     compared to people taking placebo for 16 to 40 days. Those people that continue to have~     normal liver tests after 16 days will have completed their part of the study. People that~     develop abnormal liver function tests will continue taking acetaminophen or placebo, and have~     their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure~     these tests return to normal and (2) determine when these tests return to normal while still~     taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a~     minor increase, you would be immediately told to stop taking the study drug.~      Secondary objective is to determine the proportion of subjects that have detectable~     acetaminophen-protein adducts after daily dosing.~   "
215179|NCT00743080|"~     To date, laparoscopic approach may apply to several gynecologic diseases. Among the recent~     advances in laparoscopy an important role was assumed by the methods of tissue extraction. In~     particular electronic power morcellators have become instruments of large use in surgical~     practice.~      The tissue morcellator is an endoscopic instrument indicated for cutting, coring and~     extracting tissue in operative laparoscopy, and it has a pivotal role during specific~     gynaecologic procedures as well as myomectomy and hysterectomy. The main advantages offered~     by electronic morcellator consist in reduction of operative time and of risk in hernia~     formation, this last due to the absence of fascia's tearing or stretching.~      Recently, a new generation of tissue morcellator has been commercialized. In particular,~     GYNECARE MORCELLEX (Ethicon-Johnson & Johnson Gateway, US) and ROTOCUT G1 (Karl Storz, Culver~     City, CA, US) are two tissue morcellators currently available. These instruments seem to~     offer advantages over the previous models in terms of precision, speed and durability. The~     most useful of this features seems to be the higher speed, in particular it has been~     calculated that they morcellate tissues approximately four times faster than those of the~     previous generation. The high speed that characterizes this new morcellator potentially~     results in reduced operative time with consequent benefits in other surgical outcomes such as~     postoperative pain and recovery time.~      Even if both morcellator seems to be high-quality instruments, no study was designed until~     now to compare these two tools in a prospective fashion.~   "
215180|NCT00743067|"~     This clinical study is being conducted at two sites to determine the optimum dose, safety,~     and tolerability of oral daily GSK1363089 treatment in adults with solid tumors. This study~     is no longer recruiting subjects.~   "
215181|NCT00743054|"~     In this study, renal cell carcinoma (RCC) related miRNA and the target genes of related miRNA~     will be examined in order to investigate the role of miRNA in the formation of RCC and look~     for the biomarker of RCC.~   "
215182|NCT00743041|"~     A need exists to find fast yet effective treatment protocols for the large number of US~     military service personnel coming back from Iraq with post traumatic stress disorder (PTSD),~     and a variety of co-occurring psychological problems. EFT (Emotional Freedom Techniques) has~     demonstrated promise as a PTSD treatment in pilot studies. This study examines the effects of~     six sessions of EFT coaching on veterans who score at or above the military cutoff point for~     PSTD. Subjects are also assessed for conditions that often accompany PTSD, such as depression~     and anxiety. Changes pain, cravings, and physical symptoms are also measured. Assessments are~     made after six sessions are complete, and again after three and six months.~   "
215183|NCT00743028|"~     This is a randomized, open-label, multicenter crossover study to determine the oral~     bioavailability of new ABT-263 formulations relative to that of the current ABT-263~     formulation being administered in ongoing Phase 1/2a studies. Approximately 36 evaluable~     subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors~     will be enrolled in this study.~   "
215184|NCT00743015|"~     The general aim is to evaluate the relative oral bioavailability of BI 44370 TA tablets~     during and between migraine attacks as well as Safety, Tolerability and Pharmacokinetic~   "
215185|NCT00743002|"~     This trial is designed to show the effect of treatment with TT223 or placebo on blood glucose~     control after 12 weeks of treatment with a 6 month follow-up. TT223 is administered by~     injection once daily to patients currently treated with Metformin and/or Thiazolidinedione.~   "
215186|NCT00742989|"~     The goal of this project is to see how much an osteopathic lymphatic treatment (OLT) causes~     an increase in plasma volume, total plasma protein concentration, and albumin concentration.~     This is an important step in understanding the effects of OLT, specifically its effects on~     fluid in the body. The primary role of the lymph system is the return of fluid and proteins~     lost from the blood vessels. Despite this, no research has been done to see what effects an~     OLT has on fluid and protein levels in the blood.~   "
215187|NCT00742976|"~     Hypothesis: Changing type 2 patients treatment from Insulin Insulatard to Insulin Detemir~     will increase their excretion of sodium in the urine and thereby decrease their extracellular~     volume and body weight. 24 patients are divided into 2 groups and their insulin treatment is~     shifted while their body composition, sodium excretion, weight and extracellular volume is~     monitored.~   "
215188|NCT00742963|"~     The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is~     safe and effective in the treatment of Advanced Soft Tissue Sarcoma.~   "
215189|NCT00742950|"~     The investigators' purpose is to study the induced refractive change caused by different~     2.8-mm corneal incision locations in phacoemulsification, because the investigators~     hypothesize that the effect may be different for nasal, temporal, and superior location,~     although they are considered astigmatism neutral.~      Patients will be randomized to nasal or temporal incision, or assigned to superior incision,~     depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam~     analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and~     after phacoemulsification.~      Outcome measures will be induced corneal refractive change (Fourier power vector analysis),~     ISV change, and visual acuity, at 6 months.~   "
215190|NCT00742937|"~     The purpose of this study is to evaluate the effect of maternal supplementation with 400,000~     IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial~     mother-child, on growth and morbidity of children in breastfeeding in the first six months of~     life.~   "
215191|NCT00742924|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acid~     when given together with combination chemotherapy in treating patients with newly diagnosed~     metastatic osteosarcoma.~   "
215192|NCT00742911|"~     OBJECTIVES:~      Primary Objectives~      • Determine the safety and toxicity profile of co-administration of disulfiram and copper~     gluconate for the treatment of refractory malignancies that have metastasized to the liver.~      Secondary Objectives~        -  Determine if disulfiram and copper gluconate induce measurable responses for the~          treatment of hepatic metastases from solid tumors.~        -  Qualitative assessment of the induction of S-glutathionylation in proteins of~          circulating leukocytes in patients treated with disulfiram and copper gluconate.~   "
215193|NCT00742898|"~     The purpose of this study is to evaluate the clinical effectiveness of performing opt-out~     rapid HIV screening in an urban, inner-city emergency department, as well as to evaluate its~     clinical efficiency, cost effectiveness, and patient and staff satisfaction.~   "
215194|NCT00742885|"~     This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK~     Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.~   "
215195|NCT00742872|"~     The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin~     receptors in the gastrointestinal tract, is effective in the treatment of~     constipation-predominant irritable bowel syndrome (C-IBS).~   "
215196|NCT00742859|"~     Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with~     non-valvular AF, orally administered betrixaban will provide similar or better efficacy and~     safety than warfarin and it will offer the advantage of not requiring dose adjustments due to~     international normalized ratios (INRs) outside the target range of 2.0 to 3.0 and a more~     consistent level of anticoagulation over time.~   "
215197|NCT00742846|"~     The primary objective is to compare the clinical outcomes of patients with a clinical~     diagnosis of Adhesive Capsulitis who receive intra-articular versus subacromial steroid~     injections.~      The secondary objective is to verify that steroid injections in combination with physical~     therapy lead to more favorable outcomes than local anesthetic injections in combination with~     physical therapy.~   "
215198|NCT00742833|"~     To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.~   "
215199|NCT00742820|"~     To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in~     healthy volunteers with calcium citrate as a positive control.~   "
215292|NCT00741598|"~     This study will examine whether extended release galantamine, a drug approved by the Food and~     Drug Administration to reduce cognitive impairments in people with Alzheimer's disease, can~     perform the same function in stable people with bipolar disorder.~   "
215200|NCT00742807|"~     Giving infiltration analgesia around the neck of the womb (= paracervical block, PCB) is~     frequently experienced as a painful procedure by women undergoing follicle aspiration. Two~     sedation protocols, where in the one protocol a low dose of alfentanil hydrochloride is~     already administered before the PCB, will be compared with each other and pain relief~     measured using the 'Visual Analogue Scale' and the 'Short-Form McGill Questionnaire'~   "
215201|NCT00742794|"~     In Switzerland, 3.5% of the population are suffering from hymenoptera venom allergy. The only~     causal treatment of hymenoptera alelrty is venom specific immunotherapy. There are however~     several reasons, which question the relatively broad application of this expensive treatment.~     That's why we aim at investigating the actual risk for hymenoptera stings in patients~     undergoing allergen specific immunotherapy against hymenoptera sting allergy~   "
215202|NCT00742781|"~     The purpose of this study is to determine the effect of vitamin D supplementation in Crohn's~     disease patients. Patients will be evaluated for increases in circulating vitamin D levels~     and effects on health benefits including improved bone markers, Crohn's disease activity~     scores, and inflammatory markers.~   "
215203|NCT00742768|"~     From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of~     vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7.~     However, the taste of natto is not appreciated by the western society. For this reason the~     active biological compound is produced as a capsule. Different techniques of encapsulation~     the vitamin can lead to different absorption profiles with intake. Therefore it is important~     to study influence of type of encapsulation technique on absorption of menaquinone-7.~      This study is undertaken to compare absorption of menaquinones between two different~     encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of~     conventional softgel capsules and newly developed GellpelTM capsules are compared between~     each other.~   "
215204|NCT00742755|"~     Develop and evaluate a peer navigator intervention to assist Korean women with a potential~     breast abnormality, who have missed their first follow-up appointment, to complete all~     diagnostic follow-up tests.~   "
215205|NCT00742742|"~     The purpose of this study is to determine whether a daily supplement of 30 grams of walnut is~     effective in the treatment of metabolic syndrome (MetS).~   "
215206|NCT00742729|"~     Develop and evaluate in a randomized trial an educational small group intervention to~     increase colorectal cancer screening among Filipino Americans.~   "
215207|NCT00742716|"~     This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK)~     in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT),~     undergoing regular hemodialysis. This study will also investigate the safety and effects of~     different strengths of CTA018, on parathyroid hormone (PTH) levels.~   "
215208|NCT00742703|"~     The principal objective of this research is the evaluation of the effect of mineralized water~     consumption upon evolution of LDL Cholesterol and triglycerides, compared to a low~     mineralized water consumption.~   "
215209|NCT00742690|"~     It is well known that terlipressin and albumin improve renal function in patients with~     cirrhosis and type 1 HRS. In previous studies terlipressin has been used either as~     intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr or as continuous intravenous~     infusion at the initial dose of 2 mg/24 h. Up to now the two schedules of i.v. administration~     of terlipressin have never been compared. Nevertheless, it has been hypothesized that~     continuous intravenous infusion assures a more steady profile of effect on portal pressure in~     patients with cirrhosis. Thus, the aim of the study will be to compare terlipressin given as~     i.v. bolus vs terlipressin given as continuous intravenous infusion in the treatment of type~     1 HRS in patients with cirrhosis.~   "
215210|NCT00742677|"~     RATIONALE: Abdominal pain and nausea and vomiting may be lessened by waiting after surgery~     before eating foods by mouth. It is not yet known which feeding schedule is more effective in~     patients undergoing surgery.~      PURPOSE: This randomized clinical trial is comparing two feeding schedules after laparotomy~     in patients with gynecologic cancer.~   "
215211|NCT00742664|"~     Obsessive-compulsive (OC) symptoms are often present among youth with Prader-Willi Syndrome~     (PWS). They are also associated with considerable problems in the daily functioning of the~     child and his/her family. Although medication and behavioral treatments exist that target OC~     symptoms among youth without PWS, these treatments have not been thoroughly adapted for this~     population nor scientifically tested. Although medication has been helpful in addressing OC~     symptoms in several published case reports, the associated efficacy is modest and the~     potential for side effects is a realistic concern. Given that behavioral treatment for OC~     symptoms has superior efficacy to pharmacotherapy in youth without PWS without the~     accompanying risk for adverse side effects, it follows that an adapted version of behavioral~     therapy may hold promise in treating clinically problematic OC symptoms in youth with PWS.~     Thus, the purpose of the proposed grant is to develop and pilot-test a behavioral treatment~     for OC symptoms for use in youth with PWS. This study will allow us to develop and test a~     treatment protocol aimed at reducing OC symptoms that are clinically problematic and~     negatively impact functioning and quality of life in the child and his/her family.~   "
215212|NCT00742638|"~     This is an open label, randomised, parallel-group study to compare the efficacy and safety of~     quetiapine and valproate used as monotherapy in the treatment of mania in patients~     hospitalised for an acute manic episode. After given of informed consent and undergoing~     screening procedures, the patients will be randomised into quetiapine or valproate group on~     Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28.~     Patients will not permitted to use any psychoactive or antipsychotic medications throughout~     the study period other than those expressly permitted by the protocol.~      At each centre, the same individual will administer a specific psychiatric assessment for a~     patient at all study visits in order to reduce variability in rating scale scoring. Before~     the initiation of the study, a consistency assessment will be done among the investigators~     who conduct the scale assessment in each centre.~   "
215243|NCT00742235|"~     Vitamin D deficiency (low levels of vitamin D in the blood) is a common problem. A recently~     discovered protein, called hCAP18, likely plays an important role in the immune system and~     may depend on adequate levels of vitamin D. It is not known what levels of vitamin D are~     needed to allow the body to make this protein. Nor is it known if giving vitamin D to people~     who are found to be deficient will help boost levels of hCAP18. This study aims to clarify~     the relationship between vitamin D levels and hCAP18.~   "
215213|NCT00742625|"~     This phase II trial studies the side effects and best dose of bortezomib when given together~     with daunorubicin and cytarabine and to see how well it works in treating older patients with~     previously untreated acute myeloid leukemia. Bortezomib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving bortezomib together~     with combination chemotherapy may kill more cancer cells.~   "
215214|NCT00742612|"~     The purpose of this study is to determine, in patients undergoing carotid endarterectomy, the~     effect of ARC1779 Injection on the number of microembolic signals detected by transcranial~     Doppler immediately after surgery. This study will also evaluate the safety of ARC1779~     Injection with respect to bleeding risk in patients in the peri-operative (during surgery)~     period.~   "
215215|NCT00742599|"~     Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20~     mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified in~     a randomized, double-blind, parallel-assignment design based on the percentage of patients~     having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary~     outcome measure).~      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and seven days after administration in comparison with~     the placebo group.~   "
215216|NCT00742586|"~     The purpose of this study is to identify 15 patients with autonomic failure and obtain blood~     samples for RNA from those participants and 15 control subjects within the same age range.~     The stabilized blood samples, along with a limited data set, will be shipped to Western~     Michigan University where the actual laboratory analysis (a separate study) of the samples~     will take place.~      Unique genetic inscriptions, called gene expression signatures, are currently being~     identified for many diseases, including neurological diseases. The secondary goal of this~     study is to support the research being done at WMU and they try to look for MSA-specific~     signs are present in whole blood samples of MSA patients at late-stages of the disease. This~     is a pilot study that has a long term goal (through additional studies) a MSA-specific gene~     expression signature for the development of a diagnostic test for this disease that can be~     used in the future. Other patient groups with autonomic failure, characterized by significant~     drop in blood pressure on standing, will also be included in this study, to look for similar~     genetic inscriptions.~      This pilot study is expected to last for 2 years. The investigators at WMU will need some~     de-identified health Information about the subjects, including their age at diagnosis, age~     (when sample drawn) and list of their medications~   "
215217|NCT00742573|"~     This study will determine whether combination treatment driven by patient choice is better~     than standardized medication treatment at retaining and improving Hispanic patients with~     major depressive disorder.~   "
215218|NCT00742560|"~     The purpose of this study is to evaluate the combination of elotuzumab, lenalidomide, and~     dexamethasone in subjects with relapsed multiple myeloma.~   "
215219|NCT00742547|"~     Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In~     an epidemiological longitudinal study of about 1.150 patients with type 2 diabetes mellitus~     we investigate determinants and predictors for long-term prognosis. The patients are~     recruited and supervised in practices of general practitioners of the administrative district~     of Ludwigsburg/Heilbronn (Baden-Württemberg, Germany). In a subgroup of about 200 patients~     with a dissatisfactory metabolic status (HbA1c > 7,5%) a randomised interventional study is~     performed. The intervention comprises a telephone counseling by the medical secretary of each~     practice executed in a predefined period of time. The outcome parameters of interest are the~     change of HbA1c, the development of secondary disorders and adverse events, quality of life~     and risk factor control, as well as hospitalization and mortality.~      The aim of the study was to develop an patient-centred instrument implementable in the~     routine medical care in order to enhance the prognosis of patients with type-2 diabetes~     mellitus.~   "
215220|NCT00742534|"~     Premature infants are at risk for developing bronchopulmonary dysplasia (BPD). L-citrulline~     may decrease that risk, but we do not know the safety or dose of this drug for use in~     premature babies. The purpose of this study is to determine the safety and optimal dose of~     intravenous L-citrulline in premature infants.~   "
215221|NCT00742521|"~     It has been found that in some cases, when a person with Diabetes Mellitus has an episode of~     low blood sugar,or hypoglycemia, and then later exercises, he or she is vulnerable to another~     bout of hypoglycemia during that exercise. The purpose of this study is to determine what~     factors during the previous bout of hypoglycemia might cause another bout of hypoglycemia~     while exercising later.~   "
215222|NCT00742508|"~     The primary objective of this study is to evaluate the safety and tolerability of~     SK&F-105517-D in japanese patients with chronic heart failure.~   "
215223|NCT00742495|"~     The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics and safety of~     different doses of intravenous and oral Forodesine in children with relapsed or refractory~     T-cell or B-cell precursor Acute Lymphoblastic Leukaemia or T-cell Non-Hodgkin's Lymphoma.~     Preliminary efficacy will also be assessed.~   "
215224|NCT00742482|"~     The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given~     at fixed time intervals compared to standard therapy~   "
215225|NCT00742469|"~     The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14~     days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea~     compared to placebo.~   "
215226|NCT00742456|"~     In this study we will examine if the insulin-induced microvascular effects will occur after a~     physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological~     importance of the insulin-induced microvascular dilatation can be elucidated. In this study~     we hypothesize that oral glucose intake and consequently the endogenous induced~     hyperinsulinemia will lead to insulin-induced microvascular dilatation in healthy~     normotensive subjects. Furthermore, we suggest that the insulin-mediated microvascular~     dilatation, resulting from this physiological induced hyperinsulinemia, will be less in~     hypertensive and obese subjects compared to healthy controls.~   "
215227|NCT00742443|"~     This trial is to determine whether Juvista can prevent scar formation or improve the~     appearance of scars following scar revision surgery. The trial will involve comparing Juvista~     to placebo.~   "
215230|NCT00742404|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the~     tumor. Giving bortezomib together with combination chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome~     together with bortezomib and dexamethasone works in treating patients with newly diagnosed~     multiple myeloma.~   "
215231|NCT00742391|"~     The purpose of this study is to determine whether topical application of PEP005 is effective~     for the treatment of actinic keratoses.~   "
215232|NCT00742378|"~     The Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution~     than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for~     glaucoma detection will be studied.~   "
215233|NCT00742365|"~     This study will evaluate a possible tool for predicting future effectiveness of bright light~     in treating seasonal affective disorder, winter subtype, and will examine secondary effects~     of bright light on cardiovascular risk factors.~   "
215234|NCT00742352|"~     The purpose of this study is to determine whether chemotherapy induces regression in~     atherosclerotic plaques in oncologic patients already undergoing PET FDG as part of their~     routine assessment.We will use PET FDG to assess whether the inflammation in atherosclerotic~     plaques is affected by chemotherapy and anti angiogenic therapy.~   "
215235|NCT00742339|"~     From 1999, several studies have showed that the use of vasoconstrictors in association with~     albumin are effective in the treatment of hepatorenal syndrome (HRS). The rationale of the~     use of vasoconstrictors together with albumin in the treatment of this severe complication of~     portal hypertension in patients with cirrhosis is to correct the reduction of the effective~     circulating volume due to the splanchnic arterial vasodilatation.In most of these studies~     terlipressin, a derivate of vasopressin, has been used as vasoconstrictor as intravenous~     boluses moving from an initial dose of 0.5-1 mg/4 hr. In some studies midodrine, an~     alpha-adrenergic agonist, given by mouth has been used as vasoconstrictor at a dose ranging~     from 2.5 up to 12.5 tid together with octreotide, an inhibitor of the release of glucagon,~     given subcutaneously at a dose ranging from 10 µg upt to 200 µg tid. To the day, there isn't~     a study comparing terlipressin + albumin versus midodrine + octreotide + albumin in the~     treatment of HRS in patients with cirrhosis.Thus, the aim of the study is to compare~     terlipressin + albumin vs midodrine + octreotide + albumin in the treatment of the HRS in~     patients with cirrhosis.~   "
215236|NCT00742326|"~     This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in~     patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying~     insulin resistance in patients with HIV and HCV co-infections is associated with inflammatory~     changes, liver fibrosis and a poorer response to HCV treatment. Pioglitazone is a drug that~     helps to reduce the body's resistance to insulin. It is approved by the Food and Drug~     Administration to treat diabetes.~      Patients with HIV and HCV co-infections who have hepatic steatosis (fatty liver) may be~     eligible for this study. Candidates are screened with a medical history and physical~     examination, blood and urine tests, magnetic resonance imaging (MRI) of the liver to measure~     liver fat and, if needed, a liver biopsy to confirm the diagnosis of liver steatosis.~        -  Participants are randomly assigned to take either pioglitazone therapy or placebo for 48~          weeks. This is followed by a second 48-week treatment period in which all participants~          take pioglitazone.~        -  There are approximately 12 visits during the 96 weeks of the study. Participants will~          receive a physical assessment, blood and urine tests at each visit. In addition,~          periodic assessments of dietary habits, body composition, oral glucose tolerance~          testing, and health related quality of life questionnaires will be completed.~        -  A repeat MRI of the liver is performed at 48 weeks and at the end of the study to~          evaluate any potential changes in liver fat and inflammation. In addition, there is a~          follow-up liver biopsy at 48 weeks and an optional liver biopsy at 96 weeks.~   "
215237|NCT00742313|"~     This is a prospective, randomized trial to see in patients undergoing coronary artery bypass~     grafting and endoscopically-harvested greater saphenous vein, if using FloSeal Matrix in the~     endoscopically-harvested saphenous vein wound bed decreases bleeding and complications.~   "
215238|NCT00742300|"~     While glucocorticoids and immunosuppressants ameliorate manifestations of autoimmune diseases~     in many patients, current therapies are insufficient to control the disease in a subset of~     patients, and their clinical prognosis remains poor due to the development of vital organ~     failure, cumulative drug toxicity and to the increased risk of cardiovascular disease and~     malignancy. Immunoablative chemotherapy followed by autologous hematopoietic stem cell~     transplantation (ASCT) has recently emerged as a promising experimental therapy for severely~     affected patients, providing them the potential to achieve treatment-free, long-term~     remission. The rationale for applying ASCT to autoimmune diseases has been the hope that~     immunoablation could eliminate inflammation-driving pathogenic cells from the immune system,~     and that regeneration of the patients' immune system from hematopoietic precursors could~     re-establish immunological tolerance.~   "
215239|NCT00742287|"~     Smoking has been identified as a key risk factor for the development of cardiovascular~     diseases (CVD). It was found that a persistent increase in levels of oxidative stress and~     prolonged inflammation play a pivotal role in the pathogenesis of smoking associated CVD.~     Oligomeric proanthocyanidins (OPCs) are widely known for their anti-oxidant and~     anti-inflammatory effects, in vitro and in vivo. However, there are hardly any studies~     available that systematically investigated their acute and long-term effects on vascular~     function as well as on established biomarkers of oxidative stress and inflammation in an at~     risk population such as smokers.~      Therefore, the aim of the present study is to investigate the effects of an eight-week~     supplementation with OPCs on vascular function as well as biomarkers of oxidative stress and~     inflammation in blood of smokers.~   "
215240|NCT00742274|"~     The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device~     and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B~     aortic dissections.~   "
215241|NCT00742261|"~     Study to compare 2 different chemical forms of GSK1363089.~   "
244468|NCT00354146|"~     The purpose of this study is to evaluate the effectiveness (response rate) and safety of~     tipifarnib in patients with refractory or relapsed AML.~   "
215244|NCT00742222|"~     PRINCIPAL INVESTIGATORS~        -  Rakesh Patel, MD- Radiation Oncologist~        -  Peter Beitsch, MD- Breast Surgeon~      REGISTRY DESIGN~        -  Multicenter, non-randomized, post market registry of intracavitary accelerated partial~          breast irradiation in appropriately selected patients.~      SAMPLE SIZE AND SITES:~        -  Approximately 400 patients may be enrolled.~        -  Up to 100 qualified U.S. sites may participate in this registry.~      ENDPOINTS:~        1. PRIMARY ENDPOINTS~             -  Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous~               toxicities will be recorded at the following follow-up visits; at six (6) month,~               one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.~             -  Skin Toxicities - Specific toxicities that can result from radiation therapy will~               be recorded at each follow-up visit. The Common Terminology Criteria for Adverse~               Events will be used and to be recorded at each follow-up visits; at one (1) month,~               six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five~               (5) year.~             -  Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up~               visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3)~               year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and~               graded in two ways:~             -  Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will~               be completed at the following visits; at one (1) month, six (6) month, one (1)~               year, two (2) year, three (3) year, four (4) year, and five (5) year.~        2. SECONDARY ENDPOINTS~             -  Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral~               breast failure at five (5) years.~           This includes:~             -  Ipsilateral recurrence within the initially treated volume. (Within the tumor bed)~             -  Ipsilateral recurrence of cancer outside of the initially treated volume.~               (Elsewhere Failure)~             -  Axillary nodal recurrence~                  -  Survival - to be recorded at each follow-up visit~             -  Overall Survival~             -  Disease Free Survival~                  -  Device Performance - to be recorded during the balloon applicator placement~                    and during the course of the radiation treatments:~             -  Ability to deliver treatment~             -  Axxent System / Balloon Applicator performance~        3. TREATMENT DEVICE~      The device to be used is the electronic brachytherapy system for the treatment of early stage~     breast cancer with intracavitary accelerated partial breast irradiation. The device~     manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment~     of early stage breast cancer can be used in this post market data collection registry.~      OVERSIGHT COMMITTEE~      Representatives from American Brachytherapy Society (ABS), American Society of Breast~     Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study~     management.~   "
215245|NCT00742209|"~     Purpose of the study is to evaluate dose response relationship, efficacy, safety and~     tolerability of target doses of GSK1838262 compared to placebo in the prophylactic treatment~     of migraine headache. Once subjects complete the baseline and meet the randomization~     criteria, they will complete a 5-wk flexible titration period and then enter the 12 week~     maintenance period.~   "
215246|NCT00742196|"~     Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is~     incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to~     analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary~     atrophy.~   "
215247|NCT00742183|"~     The primary objective is to compare the incremental costs (direct and indirect) and benefits~     (healing outcomes, quality of life) of using foam silver dressing (Mepilex® Ag) to a Silver~     sulfadiazine 1% cream (Silvadene®) from the perspective of the health care provider.~      The secondary objectives are to investigate the safety, the tolerance and the performance on~     burn status including pain.~   "
215248|NCT00742170|"~     This single-blind, randomized clinical trial tests whether electroacupuncture, provided as an~     adjunctive treatment, improves outcomes among patients receiving inpatient opioid~     detoxification from opioids.~   "
215249|NCT00742157|"~     Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued~     compliance to the individualized oral diet and enteral GLN, will result in reduced volume of~     TPN infusion/week and/or reduced frequency of TPN infusions/week.~   "
215250|NCT00742144|"~     This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of~     ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia~     (CLL) patients. subject will receive ofatumumab 8 weekly infusions.~   "
215251|NCT00742131|"~     This clinical study is being conducted at two sites to determine the optimum dose, safety,~     and tolerability of GSK1363089 treatment in adults with solid tumors. This study is no longer~     recruiting subjects.~   "
215252|NCT00742118|"~     Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In~     addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The~     investigators aimed to investigate:~        1. paracellular permeability in colonic biopsies of IBS patient~        2. the ability of soluble factors from colonic biopsies to reproduce in vitro these~          alterations~   "
215253|NCT00742105|"~     This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese~     patients with advanced solid tumor.~   "
215254|NCT00742092|"~     Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period/Two-Treatment~     Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in~     Patients With Cystic Fibrosis Homozygous for the F508del Mutation~   "
215255|NCT00742079|"~     This study will examine whether pretreatment with D-cycloserine before cognitive behavioral~     therapy can reduce impairments still present in people with stable cases of schizophrenia as~     well as determine which traits make schizophrenics most likely to respond to D-cycloserine~     treatment.~   "
215256|NCT00742066|"~     In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the~     insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II~     AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2.~     Does blockade of the angiotensin II AT1-receptor impair the insulin-induced microvascular~     effects in normotensive control subjects?~   "
215257|NCT00742053|"~     This study is designed to obtain information for design purposes on use of an ECG guided~     monitoring system to aid in the correct placement of PICC lines.~      There is no formal study hypothesis.~   "
215258|NCT00742040|"~     The primary objective of this study is to establish a safe and effective method of~     up-titration of captopril for hospital inpatients.~   "
215259|NCT00742027|"~     This study will evaluate the efficacy of oral panobinostat in patients with~     refractory/relapsed classical HL who have received prior treatment with high dose~     chemotherapy and autologous stem cell transplant. Safety of panobinostat will also be~     assessed. Other markers that may correlate with efficacy or safety will be explored.~   "
215260|NCT00742014|"~     The primary objective of this study is to examine the effects of Sildenafil, administered~     during cardiac catheterization, on right ventricular contractility in children with pulmonary~     arterial hypertension.~   "
215261|NCT00742001|"~     Feasibility trial to evaluate recovery and survival of RBCs from Mirasol-treated whole blood~   "
215262|NCT00741988|"~     This is a multicenter, non-randomized, Phase II study of patients with previously untreated~     NSCLC not amenable to radiotherapy or surgical treatment. The planned enrollment for this~     trial is 78 patients (including a 10% rate for inevaluable patients). There will be a total~     of 39 patients in each cohort (Cohorts A and B).~   "
215288|NCT00741650|"~     A randomized controlled trial comparing a new approach to musculoskeletal pain consisting of~     education and peer involvement to treatment as usual. All local government employees in 1-3~     Norwegian municipalities will be invited to participate.~   "
215263|NCT00741975|"~     Adolescents are at risk for HIV because of sexual and drug use behavior initiated during~     early adolescence, and those with mental health problems appear to be particularly~     susceptible. Problems with managing emotions may make it difficult for early adolescents to~     make good decisions about sexual and substance use behaviors. This project will develop and~     evaluate interventions for early adolescents with mental health issues. An intervention~     focused on teaching affect management skills will be compared to an intervention addressing a~     variety of health topics to determine which intervention best reduces risk behavior among~     this at-risk population.~   "
215264|NCT00741962|"~     The purpose of this study is to determine the safety and efficacy of VR-3 Herbal Blend and~     its effects on acute and chronic stress responses.~   "
215265|NCT00741949|"~     Fiberoptic bronchoscopy (FOB) is an important tool for the diagnosis of pulmonary diseases,~     more particularly in infectious pneumonia. In patients with severe acute hypoxemic~     respiratory failure, FOB may be contra-indicated until the patient is intubated and control~     of its oxygenation obtained. In the literature several authors showed that performing FOB~     under non invasive ventilation (NIV) preserved oxygenation of the patient; and the recent~     French Consensus on NIV recommends performing FOB under NIV in patients with acute hypoxemic~     respiratory failure.~      Nevertheless this procedure remains uncomfortable in most patients with respiratory failure.~     In addition, patient's agitation may lead to desaturation, and compromise the realization of~     FOB.~   "
215266|NCT00741936|"~     Functional constipation (FC) is a common complaint in clinical practice, but treatment for~     this condition in conventional medicine is suboptimal. Complementary and alternative~     medicines, especially Chinese herbal medicine (CHM) are used frequently by patients, however,~     there is little research evidence about these commonly used CHM. The purpose of the study is~     evaluate the efficacy and safety of an ancient CHM formula, MaZiRenWan (MZRW), by comparing~     with placebo.~   "
215267|NCT00741923|"~     This project investigates the effect of regular consumption of commercially available~     processed white beans (5 cups per week) on food intake, body weight, blood pressure, satiety~     hormones and glycemic response over a 4-week period. We have chosen to provide participants~     with canned white beans, the most accessible and frequently consumed bean in North America.~     They are inexpensive, a good source of high quality nutrients and ready to eat. Based upon~     published literature and short-term studies conducted in our laboratory, we hypothesize that~     regular consumption of commercially available canned beans will increase satiety and improve~     the control of food intake, body weight, blood glucose and blood lipids.~   "
215268|NCT00741910|"~     Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the~     only efficacy measure assessed in this study. The safety of multiple courses of semapimod is~     to be determined by the incidence of clinical and laboratory adverse events.~   "
215269|NCT00741897|"~     To determine the safety and efficacy of Fexofenadine (Telfast®) 30mg pediatric tablets on~     Filipino children aged 6 to 11 for the relief of symptoms associated with perennial and~     intermittent allergic rhinitis.~   "
215270|NCT00741884|"~     The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice~     daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of~     varenicline controlled release (CR) tablets in adult smokers.~   "
215271|NCT00741871|"~     This is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose~     limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced~     lymphoid malignancies.~   "
215272|NCT00741858|"~     The study evaluates two materials used for duraplasty of the posterior cranial fossa in~     treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix~     that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out~     of bovine pericardium and has to be sutured during application. The study compares these two~     materials used for duraplasty of patients undergoing Chiari surgery in a prospective~     randomized fashion to check the rate of surgical complications associated with each material,~     patient's outcomes, length of surgery and the hospital stay, etc.~   "
215273|NCT00741845|"~     This purpose of this study will be to conduct a double-blind, randomized, controlled clinical~     trial to determine the association between intravaginal high dose metronidazole (750mg),~     intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole +~     200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of~     persistent bacterial vaginosis.~   "
215274|NCT00741832|"~     From the relationship between pathophysiology of chronic obstructive pulmonary disease~     (COPD), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators~     hypothesize that~        1. Positive expiratory pressure (PEP) breathing will reduce dyspnea more than normal~          breathing during exercise in mild to moderate COPD patients.~        2. PEP breathing will improve dynamic hyperinflation during exercise more than normal~          breathing in mild to moderate COPD patients.~        3. PEP breathing will improve cardiorespiratory function during exercise than normal~          breathing in mild to moderate COPD patients.~   "
215275|NCT00741819|"~     This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects~     following transition from a stable dose of inhaled iloprost (Ventavis).~      Subjects are to be evaluated for safety throughout the course of the study while secondary~     assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24~     following initiation of treprostinil sodium.~   "
215276|NCT00741806|"~     It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1~     is safe and induces an immune response against influenza A H5N1. This hypothesis will be~     tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study~     assessing the safety and tolerability of single dose administration of GHB04L1 in healthy~     adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic~     properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will~     be escalated according to a fixed dose escalation scheme comprising three dose levels.~   "
215289|NCT00741637|"~     The purpose of this study is to assess the safety and immunogenicity of Peru-15~     (CholeraGarde®) vaccine in HIV seropositive adult population of Bangkok Thailand~   "
215290|NCT00741624|"~     applying a material over the exposed stromal bed following refractive surgery to prevent~     local abrasion and significantly reduce pain~   "
215277|NCT00741793|"~     This registry is a multi-center, prospective, longitudinal, observational program that will~     gather and analyse data on participants treated with infliximab, golimumab, golimumab~     Intravenous (I.V) or ustekinumab. Treatment will be prescribed by the physician according to~     actual clinical practice or standard of care for Rheumatoid Arthritis (RA), Axial~     Spondyloarthritis (AxSpA) , Psoriatic Arthritis (PsA); there will be no randomized~     assignments to treatment. At baseline and approximately every 6 months thereafter,~     information will be collected to assess safety, clinical outcomes, quality of life,~     comorbidities, pharmacoeconomics and treatment regimens among cohorts of participants~     receiving infliximab, golimumab, golimumab I.V or ustekinumab for the treatment of RA, AxSpA~     and PsA.~   "
215278|NCT00741780|"~     This is a long-term observational study of patients that were treated with at least 1 dose of~     study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).~   "
215279|NCT00741767|"~     The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing~     lung hyperinflation in COPD.~   "
215280|NCT00741754|"~     The aim of this report was to evaluate the unstimulated whole saliva flow in patients with~     head and neck cancers during and after the exclusive radiotherapy with an association of~     lauryl-diethylene-glycol-ether sodium sulfate and calcium hydroxide (Hct20). This study was~     held at the buccal cancer center of UNESP and involved thirty one patients (n = 31) divided~     into two groups: Group 1 had seventeen patients (n = 17) submitted to fractioned radiation~     treatment in the head and neck region at the total dose of 7.000 cGy and had Hct20 during the~     treatment. Group 2 with fourteen patients (n = 14) started with the use of Hct20 after the~     end of radiotherapy. A weekly and measured collection of the index of the total non~     stimulated saliva flow was done on the patients of both groups. The values that were obtained~     were analyzed statistically through the Bartlett test, the Friedman test and the Wilcox test,~     to seek an evaluation of effectiveness of the medication on the prevention of the intense~     drop of the salivary flow during the radiotherapy and do avoid the xerostomia during the~     post-radiotherapeutic period. The patients from group 1 at the end of the radiotherapy kept~     the base index of the total non stimulated salivary flow, the ones from group 2 that used the~     medication association after the radiotherapy had a great improvement of total non stimulated~     salivary flow and the usage of the Hct20 had a better result on the index of salivary flow~     during the radiotherapy.~   "
215281|NCT00741741|"~     The purpose of this study is: to determine the safety, (local) tolerability and plasma~     exposure over time of single intramuscular (IM) doses of 600 and 1200 mg of a new formulation~     (F006) of TMC278LA, to determine the safety, (local) tolerability and long-term plasma~     exposure over time of 2 dose regimens of 4 monthly IM doses of a new formulation (F006) of~     TMC278LA., To determine the safety, (local) tolerability and long-term plasma exposure over~     time of 1 dose regimen of 4 monthly subcutaneous (SC) doses of a new formulation (F006) of~     TMC278LA.~   "
215282|NCT00741728|"~     The aim of the present PPS3 study is (1) to assess the determinants of the regulation of~     heart rate and blood pressure variations and carotid properties (under different physiologic~     stimulations) and (2) to evaluate the respective contribution of heart rate, blood pressure~     variations and carotid properties to cardiovascular morbidity and mortality including sudden~     death during 10 years at least in healthy considered subjects.~   "
215283|NCT00741715|"~     The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg)~     co-administered with all approved doses of atorvastatin in a double-blind comparison with~     placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary~     hypercholesterolemia. The main objective is to evaluate the effects of the association~     AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of~     AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives~   "
215284|NCT00741702|"~     This randomized controlled trial was designed to assess whether a community-based treatment~     strategy implemented by home care nurses would be effective in controlling hypertension in~     First Nations people with existing hypertension and type 2 diabetes.~   "
215285|NCT00741689|"~     The purpose of this study is to assess safety and tolerability of AZD1656 after single~     ascending oral doses in Japanese healthy male subjects~   "
215286|NCT00741676|"~     Among surgical methods for gastric cancer, incision about 15 ~20 cm length is prepared for~     open gastric cancer surgery while 0.5 ~ 1.2 cm is for laparoscopy gastric cancer surgery.~     Complications such as pain, abdominal adhesion, and problems associated with delayed recovery~     are common in open surgery because of large incision; however, those complications are less~     common in laparoscopy surgery because small sized incision is prepared. Range of surgery for~     curative dissection depends on the level of progress of a cancer, i.e., depends on whether~     gastric wall invasion, lymph node metastasis, or invasion to adjacent organs presented. Since~     recurrence in the lymph nodes after the operation is very common, the most important step in~     the gastric surgery is to dissect lymph node completely. According to the gastric cancer~     surgery manual published by Japan Gastric Cancer Association, more than D2 lymph node~     dissection is essential for improving survival rate in advanced gastric cancer. More than D2~     lymph node dissection is relatively safely conducted by open surgery, whereas it is~     controversial in laparoscopy surgery because it is very hard to maintain surgical field under~     laparoscopic condition. Recently, widened rage of lymph node dissection by using laparoscopy~     is possible as laparoscopic surgical techniques are accumulated and new surgical devices are~     introduced. According to the case reports, D2 lymph node dissection by laparoscopy surgery~     shows similar results to the one by open surgery in aspects of recurrence rate and the number~     of dissected lymph node. Also, according to Hur and el., in case of upper gastric cancer,~     laparoscopy surgery is more useful to dissect #10 and #11 lymph node.In our prospective case~     study, the investigators would like to compare effectiveness, complications, patterns of~     recurrence, and survival rate between the two surgical approaches, laparoscopy distal~     gastrectomy and open distal gastrectomy. The investigators randomly operate the advanced~     gastric cancer patients, who need distal gastrectomy and D2 lymph node dissection. Surgical~     methods are selected randomly whether open surgery or laparoscopy surgery. Finally, the~     investigators wish our case report to contribute to the establishment of the safety and the~     effectiveness of laparoscopy surgery conducted for advanced gastric cancers. Consequently,~     our case report will contribute to establish the ideal surgical method for the advanced~     gastric cancer patients.~   "
215287|NCT00741663|"~     The question whether the sequential diuretic therapy, that means using an antialdosteronic~     drug at first and adding a loop diuretic in nonresponders, is better than the combination of~     the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites~     in patients with cirrhosis is still open. Therefore, the aim of the study is to compare~     sequential versus combined diuretic therapy in these patients. One hundred patients will be~     randomized into two groups. Group A will receive potassium canrenoate at the initial dose of~     200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day~     of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to~     150 mg/day. Group B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of~     furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.~      The percentage of responders to dthe diuretic treatment, the time to get the resolution of~     ascites and the rate of adverse effects will be compared between the two Groups of Patients.~   "
215293|NCT00741585|"~     The HYGIA study was designed to investigate prospectively~        1. the prognostic value of ambulatory blood pressure (BP) monitoring among subjects~          primarily evaluated at primary care settings~        2. the impact of changes in ambulatory BP during follow-up in cardiovascular,~          cerebrovascular, metabolic, and renal risk in hypertensive patients~        3. the influence of circadian time of treatment in cardiovascular, cerebrovascular,~          metabolic, and renal risk in hypertensive patients~        4. the prevalence of an altered BP profile as a function of antihypertensive treatment,~          circadian time of treatment, age, and presence of diabetes, among other factors.~   "
215294|NCT00741572|"~     Interstitial lung diseases (ILD) is a collective noun for various chronic lung diseases,~     including sarcoidosis and idiopathic lung fibrosis (IPF). Sarcoidosis is a multi-systemic~     disease that includes damage to the lungs in 90% of the patients. Generally, the disease can~     be described as a systemic, granulomatous and antigen-driven disorder. IPF is a disease of~     only the lungs, in which an unknown cause induces a strong inflammation reaction leading to~     acute lung damage that ultimately results in the formation of scar tissue and stiffness of~     the lungs.~      Unfortunately, the exact cause of ILD is still unknown. It is suggested that environmental~     and work-related exposure to various triggers can exert an effect on the course of the~     diseases. Examples of such triggers include bacteria, organic agents such as pollen and~     cotton dust and inorganic agents like metals and talc. Due to this unknown cause, it is~     difficult to treat ILD. Consequently, the current guideline is no medication or~     anti-inflammatory agents in severe cases. Unfortunately, this therapy is not completely~     effective.~      Triggers that are suggested to cause ILD can exert their effects via various mechanisms. On~     the one hand, they can induce an inflammatory reaction as we recently demonstrated for~     various triggers including instillation material and sicila. During such an inflammatory~     reaction, cytokines are released that can induce oxidative stress, i.e. an imbalance between~     the formation of and the protection against reactive oxygen species (ROS). On the other hand,~     ILD-inducing triggers may directly cause an increased ROS production that subsequently can~     evoke an inflammatory reaction.~      The objective of the current study is to investigate the individual sensitivity for the~     development of ILD after exposure to various triggers. Main focus will be the differences in~     the formation of and the protection against ROS as well as the occurring inflammatory~     reaction after exposure to such triggers.~      Furthermore, a simple blood test will be developed to study and eventually even predict the~     individual reaction of subjects to various triggers.~      Finally, to fully characterize the development of ILD after exposure to various triggers, the~     exhaled air of patients will be studied in order to identify specific markers of oxidative~     stress and damage.~   "
215295|NCT00741559|"~     The first aim of this study are to evaluate the lobar concordance of FDG-PET and MEG with~     intracranial electrographic study in children with intractable partial epilepsy. The second~     aim is to determine if the combined role of FDG-PET and MEG improve detection of~     epileptogenic zone as defined by invasive intracranial recordings.~   "
215296|NCT00741546|"~     This study investigates if reduced serum levels of vitamin D concentration are a typical~     feature in patient group with low left ventricular function admitted for cardiac surgery~     interventions. and also the necessity of more preventive strategies for adequate nutrition of~     these patients with more focus on intake of vitamin D before admission to cardiac surgery.~   "
215297|NCT00741533|"~     To study the quality of life of patients earlier diagnosed for cervical cancer and cervical~     intraepithelial neoplasia (CIN).~   "
215298|NCT00741520|"~     Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular~     disease even in the absence of hypertension. However, there are few data regarding the impact~     of OSA on the preHypertension and Masked Hypertension in apparently normotensive patients~     with OSA as well as the impact of treatment with continuous positive airway pressure.~   "
215299|NCT00741507|"~     Unhealthy alcohol drinking is negatively influencing health of people and costing a large~     number of annual finance via secondhand effects. Additionally, unhealthy alcohol use covers~     a spectrum that is associated with varying degrees of risk to health. The investigators~     hypothesized that unhealthy alcohol drinking resulted in significant increase in anesthetic~     requirement during general anesthesia. This investigation would clarify the association~     between unhealthy alcohol use and the intraoperative consumption of anesthetics, and provide~     clinical evidence for preoperative assessment with respect to the alcohol drinking habit.~   "
215300|NCT00741494|"~     The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select~     sperm for ICSI will result in increased pregnancies especially with men that have a low~     hyaluronan binding score (HBA).~   "
215301|NCT00741481|"~     Study hypothesis : early decrease in fdg-pet measured SUV max after 1 cycle of chemotherapy~     can accurately predict response of chemotherapy as assessed by conventional radiology after 3~     cycles of chemotherapy.~      FDG-PET imaging will be done at J0 and J14 of a new line of chemotherapy treatment in~     metastatic colorectal cancer.~      SUV max will be recorded and delta SUVmax will be compared to the results of conventional~     radiological evaluation after 3 courses of chemotherapy. Results will also be compared to the~     time to disease progression.~   "
215302|NCT00741468|"~     This study will assess possible drug-drug interactions with specific isoenzymes over a total~     study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples~     collected post dose will be analyzed.~   "
215303|NCT00741455|"~     The purpose of this study is to determine disease-free survival, overall survival, time to~     progression, regimen-related toxicity and/or treatment-related mortality in patients with~     hematologic malignancies treated with non-myeloablative chemotherapy followed by allogeneic~     stem cell transplant.~   "
215304|NCT00741442|"~     The purpose of this study is to determine whether RDEA806 is effective in the treatment of~     hyperuricemia in gout patients.~   "
215305|NCT00741429|"~     The main purpose of the trial is to evaluate pulmonary function in subjects who had completed~     any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an~     additional 2-month safety follow-up.~   "
215306|NCT00741416|"~     Blood samples and health information (e.g., age at diagnosis, test results) are collected for~     the purposes of genetic research. The blood samples are assigned a number and stored in a~     repository for safe keeping until they are needed for a research project. Participants are~     persons who are healthy (not having high blood pressure, diabetes, or high cholesterol~     levels) or persons who have Coronary Artery Disease (CAD) and live in Indiana. Participants~     complete a questionnaire at the time the blood sample is drawn and are contacted once a year~     to update their health history. Researchers apply to the Fairbanks Institute for use of the~     blood samples and health information minus participant names and contact information. Their~     research is required to be related to find genes or substances made by genes that may be~     involved in Coronary Artery Disease with the purpose of improving the investigators~     understanding of the illness potentially leading to the development of new diagnostic tools~     for identifying the illness, new treatments,or preventative measures. This study will be~     repeated for other disorders like Diabetes and Cancer.~   "
232573|NCT00511966|"~     The objective of this Observational study is to evaluate hygiene-dietetic habits as~     co-adjuvant treatment of the pharmacologic therapy use to treat Gastroesophageal Reflux.~   "
215307|NCT00741403|"~     An open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose~     (MTD), efficacy, and pharmacokinetics (PKs) of CPI-613 given twice weekly for three~     consecutive weeks in cancer patients~      The objectives of this study are:~        -  To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive~          weeks.~        -  To determine pharmacokinetics of CPI-613 following intravenous (IV) administration.~        -  To observe the anti-tumor effects of CPI-613, if any occur.~   "
215308|NCT00741390|"~     The procurement of blood for SMBG, usually via a finger stick, is considered by many patients~     to be the most painful portion of diabetes therapy. This has led to the marketing of smaller~     gauge lancets, lancing devices with variable depth settings and blood glucose sensors that~     require less blood for measurement.~      In this study, two main outcomes were evaluated: The first, which was assessed at Visit 1,~     was whether specific combinations of lancets and lancing devices would yield sufficient blood~     volume to allow valid assessment of diabetic subjects' glucose levels. The other outcome,~     assessed at Visit 2, was the level of pain perceived by subjects during lancing with specific~     combinations of lancets and lancing devices. During Visit 2, pain assessment was done using a~     Visual Analog Scale and such that for each lancet/lancing device, the lowest lancing device~     setting that yielded a valid BG reading for each subject during Visit 1 was used. A third~     outcome measure, overall comfort with lancing, was also assessed at Visit 2.~      A total of 5 combinations of lancets and lancing devices were evaluated.~      These were as follows:~        -  BD/33G = BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™~          (BGM) and OneTouch® Ultra® test strips)~        -  OTM/33G =OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch®~          UltraMini™ (BGM) and OneTouch® Ultra® test strips)~        -  OTM/28G =OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured~          with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)~        -  OTU/28G = OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM~          measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)~        -  ACC/28G= Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured~          with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip)~      After enrollment and qualification, subjects were assigned to one of 4 intervention arms. The~     arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the~     subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would~     evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to~     each arm are shown in the Assigned Interventions Table below.~   "
215309|NCT00741377|"~     This study has two portions, a phase I portion and a phase II portion. The purpose of the~     phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose~     limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in~     combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple~     myeloma patients.~      The phase II portion of the study will also be conducted in relapsed or refractory multiple~     myeloma patients. Patients will be treated with various doses of BHQ880 or placebo in~     combination standard chemotherapy. In the phase II portion of the study zoledronic acid will~     be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy.~     This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic~     acid-free environment. The purpose of the phase II portion of the study, is to determine one~     or more doses of BHQ880 for further development based on dose-efficacy modeling. Efficacy is~     defined as time to first skeletal-related event and change in bone markers for bone~     resorption and formation relative to placebo. A skeletal-related event is defined as:~        -  Pathologic fracture~        -  Spinal cord compression~        -  Requirement for either radiation or surgery to bone due to:~             -  Pain~             -  Prevention of imminent fracture~             -  Stabilization of a fracture Biomarker and imaging endpoints will be assessed in~               both phases of the study. The pharmacodynamic effects of BHQ880 will be assessed by~               measuring biochemical markers of bone formation, resorption, and metabolism in~               serum and urine. Charges in serum DKK1 levels will be characterized. The size and~               number of lytic bone lesions as measured by bone survey (X-ray) or MRI will be~               assessed. In addition, bone mineral density (BMD) will be measured by DEXA scan and~               at selected sites with QCT scans.~   "
215310|NCT00741364|"~     There is much interest in understanding the role that vitamin D3 (cholecalciferol) plays in~     various cancers, and in the prognosis of various cancers once they are discovered. The~     purpose of this study is to examine the effects of vitamin D on prostate cancer-associated~     lesions and on vitamin D metabolites in prostate tissue. We will give vitamin D3 to men when~     they are scheduled to have their prostate removed because of cancer. The men will take~     vitamin D at one of 3 doses for 4-6 weeks, until the surgery is performed. We will compare~     the prostate tissue taken from the men receiving the higher doses of vitamin D to tissue from~     men assigned to the lower doses. We expect to find that the prostate removed at surgery from~     men who received the high-dose vitamin D treatment will appear more normal, and less cancer~     like. In addition, we will measure vitamin D metabolites in the prostate to confirm that~     these did accumulate in the prostate to bring about the effects observed.~   "
215311|NCT00741351|"~     This protocol, NeuroMorfeo, aims to assess equivalence between volatile and intravenous~     anesthetics for neurosurgical procedures.~   "
215312|NCT00741338|"~     The purpose of this study is to see if treatment with an antigen-specific immunosuppressive~     can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme~     replacement therapy with laronidase in severe Mucopolysaccharidosis I (MPS I) participants.~   "
215313|NCT00741325|"~     This is a long-term observational study of patients that were treated with at least 1 dose of~     study treatment (plerixafor or placebo) in the AMD3100-3101 protocol (NCT00103610).~   "
215314|NCT00741312|"~     The purpose of this study is to determine the effect of regular aerobic exercise on~     endothelial function in pregnancy.~   "
215315|NCT00741299|"~     The purpose of this study is to examine whether tobacco smoking is associated with bipolar~     affective disorder (severity of depressive and manic symptoms, presence of psychotic~     symptoms, history of a suicide attempts and other clinical features.)~   "
215316|NCT00741286|"~     RATIONALE:~        -  Elevation in pulsatility indices (PIs), measured by transcranial Doppler (TCD), has been~          postulated to reflect downstream increased vascular resistance caused by small-vessel~          disease (SVD).~        -  Small arterial vessels are a significant determinant of vascular resistance and PIs are~          elevated when SVD is present in the intracranial circulation.~        -  Cilostazol, a phosphodiesterase III inhibitor, has other non-antiplatelet effects, such~          as vasodilation and neuroprotective effect. It has been shown to be effective in the~          secondary prevention of stroke especially in the SVD and it may be related to the other~          non-antiplatelet effects of cilostazol.~      OBJECTIVES:~        -  In this study, we aim to investigate whether cilostazol affects the changes of PIs in~          patients with acute lacunar infarction using serial TCDs.~        -  Our hypothesis is that cilostazol has other non-antiplatelet effects such as~          vasodilation effect and may decrease the vascular resistance in patients with acute~          lacunar infarction. Hence, cilostazol will decrease the PIs in patients with acute~          lacunar infarction.~   "
215317|NCT00741273|"~     This study will evaluate the safety and pharmacokinetics of two doses of orally administered~     Proellex® in female patients with impaired hepatic function and healthy volunteers with~     normal hepatic function.~   "
215344|NCT00740922|"~     The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin~     gel compared with sterile placebo gel treatment 12 months or more after the last dose was~     administered in 1 of 2 double-blind trials [neither the physician nor the patient knows the~     name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005].~   "
215473|NCT00739193|"~     The primary objective of this trial is to compare the relative hemodynamic effect of a novel~     intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push,~     with placebo and with the currentlyl available formulation of Amiodarone IV, administered as~     a 10-minute IV infusion, on systolic arterial pressure.~   "
215318|NCT00741260|"~     This is a world wide phase 1/2, open-label, study of neratinib in combination with~     capecitabine, conducted in 2 parts.~      In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the~     combination of neratinib and capecitabine. Each subject will participate in only 1 dose~     group.~      Additional subjects may be included at any dose level to further assess the safety and~     tolerability at that dose level.~      In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive~     treatment with the combination of neratinib and capecitabine at the maximum tolerated dose~     level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be~     enrolled in Part 2.~      Depending on the safety and activity profile observed during the dose escalation phase, the~     dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the~     combination is discontinued due to intolerance the other test article can be administered~     alone.~      The primary objectives of Part 1 are to assess the safety and tolerability, and to define the~     maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with~     advanced solid tumors.~      The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1.~      The secondary objective of Part 1 is to collect information on preliminary anti-tumor~     activity of the combination of neratinib and capecitabine.~      Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain~     additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive~     breast cancer treated at the MTD of neratinib + capecitabine.~   "
215319|NCT00741247|"~     The purpose of this study is to find a role of EUS-B-FNA in the mediastinal staging of~     potentially operable lung cancer. The investigators perform EBUS-TBNA and EUS-B-FNA on~     potentially operable lung cancer patients. The investigators perform EBUS(+/- TBNA) and EUS-B~     (ultrasonographic examination through the esophagus) on all subjects. EUS-B-FNA will be~     performed on inaccessible nodes or difficult nodes to be sampled by EBUS-TBNA. Additional~     diagnostic values of EUS-B-FNA as compared to EBUS-TBNA alone will be estimated.~   "
215320|NCT00741234|"~     This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will~     assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with~     advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in~     cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and~     tolerability of SB939 in combination with standard azacitidine therapy.~   "
215321|NCT00741221|"~     This trial will evaluate the efficacy and safety of pemetrexed and bevacizumab combination in~     patients with pretreated, advanced non small cell lung cancer (NSCLC).~   "
215322|NCT00741208|"~     The purpose of this study is to determine if dietary supplementation with soy isoflavones in~     persistent asthma improves airway reactivity as determined by PC20 to methacholine.~   "
215323|NCT00741195|"~     This trial will evaluate the efficacy and safety of docetaxel plus bevacizumab in patients~     with pretreated, advanced non small cell lung cancer (NSCLC).~   "
215324|NCT00741182|"~     The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture~     healing in postmenopausal women with fractures of the hip or shoulder.~   "
215325|NCT00741169|"~     The purpose of this study is to assess the interactions seen when somebody doses with~     TMC435350 and Rifampin (commercial form of antibiotic).~   "
215326|NCT00741156|"~     The primary objective of this study is to study the acute effects of angiotensin-converting~     enzyme inhibitor (ACEI) on systemic, pulmonary and cerebral blood flow in post bidirectional~     cavopulmonary connection (BCPC) patients.~   "
215327|NCT00741143|"~     This study is designed to evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in~     improving cognition, hemoglobin, iron status and total body iron among school children in~     urban Bangalore.~   "
215328|NCT00741130|"~     Because the measurement of the retinal nerve fiber layer thickness is very sensitive to the~     position of measurement, it may be incorrect in patients with the tilted disc. In the present~     study, the corrected RNFL thickness by the optic nerve head configuration using the Cirrus HD~     OCT will be evaluated. If the corrected RNFL thickness is more sensitive to detect the~     localized RNFL defect, the present software should be upgrade to reflect the optic nerve head~     configuration.~   "
215329|NCT00741117|"~     The purpose of this study is to determine if higher levels of bilirubin in the blood of~     people with liver disease affects how accurate a pulse oximeter machine is able to measure~     the concentration of oxygen in the blood. Previous studies have reported conflicting results~     regarding the affect of high levels of bilirubin in the blood on the accuracy of the pulse~     oximeter reading. Initial studies showed an underestimation of the oxygen concentration in~     the presence of elevated bilirubin. Subsequent studies have suggested that high levels of~     bilirubin in the blood do not influence the accuracy of the pulse oximeter machine. However,~     recent reports in bone marrow transplant literature and our personal observations in patients~     with liver disease suggest that high bilirubin levels are associated with an overestimation~     of the oxygen concentration as measured by the pulse oximeter machine.~   "
215330|NCT00741104|"~     This observational study will explore the Swedish national population of patients with~     rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who~     may be eligible for a dose reduction study. Patients will be asked a variety of questions~     regarding their treatment dosing and disease activity, and then asked whether or not they~     would consider participating in a dose reduction study. Patients in this study will be~     described in terms of demographic and disease characteristics.~   "
215331|NCT00741091|"~     CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early~     clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in~     routine clinical practice and to assess the adequacy of the Boston Scientific Corporation~     (BSC) Carotid Stenting Training Program.~   "
215332|NCT00741078|"~     The investigators hypothesized combination therapy would be superior to monotherapy.~   "
215333|NCT00741065|"~     Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock~     wave therapy in combination with coronary artery bypass grafting.~   "
215474|NCT00739180|"~     In this randomized controlled trial, we will examine the effect of a 3-month exercise~     training (aerobic exercise versus resistance exercise) without calorie restriction on total~     and regional adiposity, and risk of type 2 diabetes in overweight children and adolescents.~   "
215334|NCT00741052|"~     Cholera is an important diarrhoeal disease and an important cause of death, particularly~     during epidemic outbreaks, in Bangladesh and many other developing countries. Used as an~     adjunct to management of dehydration, antimicrobial therapy using an appropriate agent~     reduces diarrhoea duration and stool volume in severe cholera by about half.~      The usefulness of antimicrobials has, however, been greatly eroded by the increasing~     prevalence of resistant strains of V. cholerae O1. From October 2004 at the Matlab Hospital~     and from December 2004 at the Dhaka Hospital of ICDDR, B, V. cholerae strains became~     increasingly resistant to tetracycline and erythromycin- two drugs used in the treatment of~     severe cholera in adults and children respectively. Because of this high prevalence of~     resistance we resorted in early 2005 to using ciprofloxacin for treatment against multi drug~     resistant V. cholerae. Although all isolates were susceptible to ciprofloxacin when standard~     thresholds for disc-diffusion or E-test were used, but majority of the strains demonstrated a~     MIC value of 0.250 µg/ml, over hundred-folds greater than the V. cholerae strains tested in~     earlier years, which generally had a MIC of <0.003 µg/ml.~      In this randomized, double blind, controlled trial we will assess clinical and~     bacteriological response to 12 hourly oral dose of ciprofloxacin for 3 days in which the~     first two doses will be 1 g each and the later 4 doses will be 500 mg each, and compare them~     with a single 1 g oral dose of azithromycin. We are using azithromycin as the comparator drug~     because current circulating V. cholerae isolates are susceptible (MIC ≤ 0.125 µg/ml) to this~     azithromycin, and single-dose azithromycin has been evaluated earlier to be effective in the~     treatment of cholera.~   "
215335|NCT00741039|"~     Infections due to influenza and pneumococcus can be very serious and cause death. Anyone can~     get these infections. However, some people are at greater risk from the disease, including~     people 65 and older, the very young, and people with special health problems such as people~     with certain types of cancer, heart, lung, or kidney disease, or diabetes. Influenza can~     cause a very serious lung infection (pneumonia) and increase the risk of stroke and heart~     attacks. Pneumococcal disease can lead to serious infections in the lungs (pneumonia), the~     blood (bacteremia), and the covering of the brain (meningitis). People with the special~     health problems mentioned above are even more likely to die from the disease. Although there~     are drugs to treat these infections, they are not always effective. This makes prevention of~     the disease through vaccination even more important.~      This study will look at the body's response to influenza and pneumococcal vaccination. We~     want to see how well they it will protect. Immunization is the same as vaccination. Our goal~     is to protect as much as we can. We are doing the study because more information is needed to~     see how well older patients with cancer respond to these vaccines and how well they protect~     against disease caused by influenza and pneumococcus.~   "
215336|NCT00741026|"~     The purpose of this clinical research study is to examine the acute hormonal and metabolic~     effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The~     hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2)~     rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by~     having volunteers undergo two glucose tolerance tests in a crossover study design.~   "
215337|NCT00741013|"~     In this randomized, double-blind, placebo controlled trial we used positron emission~     tomography to determine if lovastatin or recombinant human activated protein C exhibit~     anti-inflammatory effects in humans following intrabronchial installation of~     lipopolysaccharide (LPS or endotoxin).~   "
215338|NCT00741000|"~     Observe the effects of Cervical Stairstep on Cervical Spine Range of Motion~   "
215339|NCT00740987|"~     This multicentre open-label randomized parallel-group trial aims to compare the association~     of intermittent pneumatic compression of the lower limbs + elastic stockings + anticoagulant~     prophylaxis to anticoagulant prophylaxis alone on the incidence of venous thromboembolism~     systematically evaluated at day 6, in patients hospitalized in intensive care units and~     without high bleeding risk.~   "
215340|NCT00740974|"~     Long-term cognitive outcome study of children who participated in randomized trials of~     LCP-supplemented formula during infancy.~   "
215341|NCT00740961|"~     RATIONALE: Learning about changes over time in older patients' ability to function after~     receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term~     effects of treatment and plan the best treatment.~      PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or~     colon cancer.~   "
215342|NCT00740948|"~     CLINICAL PHASE II INDICATION Sjogren's syndrome RATIONALE Sjögren's syndrome (SS) is an~     autoimmune disorder affecting 0.2% to 3% of the general population. Pharmacological treatment~     can improve the sicca symptoms, often transiently, but they are unable to modify the course~     of the disease.Open label studies suggested that low-dose rituximab produced acute and~     complete CD20 depletion in blood and tissue; was well tolerated without corticosteroid use;~     and significantly improved glandular and extra-glandular manifestations of pSS. Larger~     controlled studies are now warranted. Our hypothesis is that two infusions of 1000 mg of~     Rituximab may be better than placebo to treat patients suffering from pSS. To test this~     hypothesis, we propose to compare patients with recent and/or severe pSS treated with either~     Rituximab or placebo.~      OBJECTIVES Primary objective : Evaluation of the efficacy defined as a 30% improvement~     between Day 1 and Week 24 in the values on 2 of the 4 VAS measuring global scores of the~     disease (activity of the disease including extra glandular manifestations), joint pain,~     fatigue, and the most disturbing dryness.Secondary objectives : Variations from baseline to~     week 24 of:~      The 0-100-mm VAS scores for dry mouth, dry eyes, dry trachea, dry vagina, and dry skin;~     fatigue; pain; Tender and swollen joint counts; Tender points; Other systemic manifestation;~     Unstimulated salivary flow rate; Schirmer and van Bijsterveld scores (2-3); C-reactive~     protein (CRP) and erythrocyte sedimentation rate (ESR); rheumatoid factor (RF); ANA; serum~     IgG, IgA, and IgM; complement; cryoglobulinemia; and counts of B and T cells; Evaluation of~     the safety of Rituximab during the study Evaluation of the improvement evaluated on VAS by~     the physician Evaluation of the disease activity scores as suggested by Bowman and Vitali~     Evaluation of Chisholm score, B cells characteristics and DNA microarray on labial accessory~     salivary gland (SG) biopsy samples, and salivary gland echography at inclusion and at week~     24.~      TRIAL DESIGN Multicenter, randomized, double-blind, placebo-controlled trial NUMBER OF~     SUBJECTS : 120~   "
215343|NCT00740935|"~     Universal rotavirus vaccination program for infants born in Brest after February 2007,~     applied by the Centers for Maternal and Infant Health Protection, pediatricians and general~     practitioners.~      Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units~     of Brest University Hospital with systematic testing for Rotavirus.~      Evaluation of the impact of the vaccination program on rotaviral gastroenteritis~     hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from~     2002-2007 in the absence of vaccination.~      The principal judgement criterion is the number of pediatric hospitalizations for rotaviral~     GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the~     suburbs of Brest.~   "
215345|NCT00740909|"~     This study aims to develop a comprehensive Cognitive Behavioral Therapy protocol for adult~     patients with Trichotillomania that emphasizes relapse prevention and that addresses comorbid~     affective symptoms, as well. The study will compare the efficacy of CBT with a minimal~     attention control (MAC)condition. We hypothesize that outcome at post-treatment, 3-month, and~     6-month follow-up will be better for the CBT vs. MAC condition including higher responder~     rates and greater reduction in hair pulling severity.~   "
215346|NCT00740896|"~     Airway dendritic cells control pulmonary immune responses to inhaled particles. It is the aim~     of the present study to investigate the acute effects of smoking on the number and surface~     molecule expression of human airway dendritic cells.~   "
215347|NCT00740883|"~     Rational: After 3 or 6 months of oral anticoagulation for an episode of acute venous~     thromboembolism (VTE), the risk of recurrent VTE is high (10 to 15% per year) in comparison~     with a low risk of recurrence if VTE was provoked by a major transient risk factor such as~     recent surgery (3% per year) independently of the initial presentation (deep vein thrombosis~     or pulmonary embolism). After a first episode of idiopathic VTE, 3 months of anticoagulation~     is associated with a very high risk of recurrence (27% per year); however, the benefit-risk~     of extended duration of anticoagulation (1 to 2 years) remains uncertain, mainly in relation~     with an increased risk of anticoagulant related bleeding. Therefore, the last ACCP conference~     group recommended 6 months of oral anticoagulant therapy after a first episode of idiopathic~     VTE. However, this recommendation is likely to be inadequate for at least two main reasons:~     (1) no studies compared 2 years to 6 months of anticoagulation after idiopathic VTE; and (2),~     if the frequency of recurrent VTE is similar after deep vein thrombosis and pulmonary~     embolism, however, the case fatality rate of recurrent VTE is higher after pulmonary embolism~     (12%) than after deep vein thrombosis (5%).~      Objective : the main objective is to demonstrate that, after 6 months of oral anticoagulation~     for a first episode of idiopathic pulmonary embolism, 18 months of warfarin therapy is~     associated with a lower cumulative risk of recurrent VTE and major bleeding in comparison~     with that on 18 months of placebo. The secondary objectives are: (1) to determine the risk of~     recurrent VTE after 6 months of warfarin therapy and the presence or the absence of residual~     lung scan perfusion defect and the persistence or not of elevated D-dimer test; and (2), to~     determine the impact of extended duration of anticoagulation on the risk of VTE after~     stopping anticoagulant therapy on a follow-up of 2 years.~      Method : French multicenter double blind randomized controlled trial. Inclusion and exclusion~     criteria and pulmonary diagnostic criteria have been defined. After completing 6 months of~     oral anticoagulation, a lung scan and D-dimer testing are performed; the investigators and~     the patients will be unaware of the results of these tests. Then, patients are randomized to~     receive 18 months of warfarin therapy or 18 months of placebo (the dose of placebo will be~     adapted according to false computer generated INR). The investigators, the radiologists and~     the patients are blinded of the treatment allocation. The project will be submitted to~     national ethical committee and written consent will be obtained from all included patients.~      Required number of patients: the expected cumulative frequency of recurrent VTE and major~     bleeding over 18 months is 4.5% while on warfarin therapy and 16% while on placebo. For a α~     risk of 5% (to falsely conclude to a true difference) and a β risk of 10% (to falsely~     conclude to an absence of difference), 178 patients per group should be included. As 5% of~     patients are expected to be loss, a total of 374 patients is required.~      Feasibility: about 50 patients per year are hospitalized in our department of medicine in~     Brest for an acute episode of idiopathic pulmonary embolism. Four additional centers will~     participate to the study and have a similar recruitment: HEGP (Pr Meyer, Dr Sanchez), CHU~     Antoine Béclère (Dr Parent, Pr Simmoneau), CHU Saint Etienne (Pr Mismetti, Pr Décousus), CHU~     Grenoble (Pr Pison, Pr Carpentier). The study will be coordinated by the Clinical Center of~     Investigation of Brest Hospital; true and false INR will be generated by the clinic of~     anticoagulant of Ile de France (Dr Cambus).~      Clinical implications: the first consequence of the study is to demonstrate that 6 months of~     warfarin therapy is inadequate and should be continued for at least 18 additional months~     after a first episode of idiopathic pulmonary embolism. This study has also the potential to~     confirm or not the contribution of lung scan and D-dimer testing to appreciate the risk of~     recurrent VTE after stopping anticoagulant therapy. Lastly, the medical economical impact of~     such therapeutic management will be evaluated.~   "
215348|NCT00740870|"~     The primary objective is to confirm the long-term functionality of implantation of the~     Medtronic Melody TPV at 5 years is no worse than the historical control established through~     literature review. The secondary objectives are to assess safety, procedural success, and~     clinical utility of transcatheter implantation of the Melody TPV.~   "
215349|NCT00740857|"~     This is a study of healthy volunteers to compare how quickly different ibuprofen products~     relieve dental pain.~   "
215350|NCT00740844|"~     This multicentre open-label randomized parallel-group trial aims to evaluate the association~     intermittent pneumatic compression + elastick stockings versus elasting stockings alone on~     symptomatic or asymptomatic venous thromboembolism incidence, evaluated systematically at day~     6 (+/-2days), in patients hospitalized in intensive care units and with high bleeding risk.~   "
215351|NCT00740831|"~     This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month~     period for the pre-operative treatment of pre-menopausal women suffering from excessive~     uterine bleeding due to uterine myoma.~   "
215352|NCT00740818|"~     The purpose of this study is to determine the effects of Logan Basic Technique on symptoms of~     dysmenorrhea.~   "
215353|NCT00740805|"~     This phase I trial studies the side effects and best dose of veliparib, cyclophosphamide, and~     doxorubicin hydrochloride when given together in treating patients solid tumors or~     non-Hodgkin lymphoma that has spread to other areas of the body or cannot be removed by~     surgery. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     veliparib, cyclophosphamide, and doxorubicin hydrochloride may kill more cancer cells.~   "
215354|NCT00740792|"~     The purpose of this study is to determine if two allergy medications (formulated azelastine~     and fluticasone product) are more effective than placebo or either medication alone~     (azelastine or fluticasone)~   "
215355|NCT00740779|"~     The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with~     placebo in the treatment of subjects with moderate to severe abacterial chronic~     prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary~     objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.~   "
215356|NCT00740766|"~     The aim of this prospective randomized study is the prevention of excessive weight gain in~     obese pregnant women. The study will compare perinatal outcomes of obese pregnant women~     treated in the traditional way to outcomes of nutritionally monitored obese pregnant women~     and evaluate a preliminary behavioral model applicable to the general practice of obstetrics.~   "
215357|NCT00740753|"~     Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their~     cancer. The purpose of this protocol is to provide supervised access at Oregon Health and~     Science University to Y-90 treatment to provide these patients access to an alternate~     therapy. The radioactive beads are placed directly near or into the liver tumor with the~     intention of destroying the tumor cells.~   "
215358|NCT00740740|"~     The purpose of this study is to identify possible in vivo biochemical and biological markers~     related to aortic wall strength.~   "
215359|NCT00740727|"~     Test whether Basic Life Support (BLS) providers can successfully place Enzymatically~     Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and~     characterize intravascular absorption of EASI-administered (tracer-labelled) glucose (D5W).~   "
215360|NCT00740714|"~     The purpose of this study is to evaluate the safety and effectiveness of high dosages of~     Coenzyme Q10 in slowing clinical decline in people who have early Parkinson disease.~   "
215361|NCT00740701|"~     Functional neuroimaging studies have shown that the cerebellum is active during cognitive~     performance. The investigators hypothesize that stimulation of the cerebellum with~     transcranial magnetic stimulation will produce brief changes in performance of the task,~     suggesting that cerebellar activation is necessary for normal cognitive function.~   "
215362|NCT00740688|"~     This is an experimental study to examine whether a chiropractic intervention (specifically~     Logan Basic Technique) can help restore balance distribution in individuals with or without~     vertebral subluxations.~   "
215363|NCT00740675|"~     Adverse drug events (ADEs) after hospital discharge are common. The purpose of this research~     study is see if we can design an electronic tool given to your primary care provider (PCP)~     that will reduce adverse drug events, hospital readmissions, and emergency department visits~     after you are discharged from the hospital.~   "
215364|NCT00740662|"~     An important step during a gastric bypass operation for the treatment of morbid obesity is~     the measuring of the small bowel length. At several reoperations we found a length increase~     of the lowest part of the small intestine of up to 80% compared to the measured length at the~     initial operation. On the one hand, this reflects a normal technical error of small bowel~     measuring due to the variable state of contraction of the bowel, but on the other hand, it~     could also be due to a compensatory increase in intestinal length after the operation. New~     protocols allow measuring of the small bowel length by MRI. Comparing the preoperative and~     later on several postoperative measurements by MRI with the initial intraoperative length~     measuring should allow to validate the new MRI protocol and in the same time quantify the~     eventual small bowel length increase. We plan to include 20 patients in this study.~   "
215365|NCT00740649|"~     This is a single ascending dose study of HSD-016 to provide the initial assessment of the~     safety, tolerability, how the drug is absorbed and eliminated, and it's effect on the body in~     Japanese male subjects.~   "
215366|NCT00740636|"~     The purpose of this study is to determine whether treatment with temozolomide will shrink~     small cell lung cancer tumors. Temozolomide is an oral chemotherapy drug that is currently~     used to treat brain cancer and melanoma.~      As part of this study, we will be doing additional tests that may help us understand how~     temozolomide works. First, if there is a tumor sample from a biopsy done in the past, it will~     be analyzed for an abnormal gene that may be present in lung cancer. Before starting~     temozolomide, a research blood test will be done to look for the same abnormal gene we are~     looking for in your tumor sample. Also, before starting temozolomide and every time you have~     a repeat CT scan, a research blood test will be done to analyze the number of tumor cells in~     your bloodstream.~   "
215367|NCT00740623|"~     The purpose of this study is to evaluate the effectiveness, safety, and tolerability of~     carisbamate as add-on therapy for the treatment of partial onset seizures in patients with~     epilepsy.~   "
215368|NCT00740610|"~     The overall purpose of this study is to examine the safety, tolerability, pharmacokinetics~     (how the body processes a drug), and activity of GS-9450 in preventing liver damage due to~     scarring, or fibrosis, caused by Non-Alcoholic Steatohepatitis (also known as NASH).~   "
215369|NCT00740597|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation~     therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that~     needs to be removed.~      PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation~     therapy and to see how well it works in treating patients undergoing surgery for stage IB,~     stage II, or stage III soft tissue sarcoma.~   "
215370|NCT00740584|"~     To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and~     herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up~     to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this~     study.~   "
215371|NCT00740571|"~     Rationale: Often, incurable cancer patients suffer from severe symptoms as (neuropathic) pain~     and fatigue with polypharmaceutic interventions as a consequence. Regarding neuropathic pain~     in incurable cancer patients, pregabalin has been registered for neuropathic non-cancer pain,~     and amitriptyline is not registered for neuropathic pain, but is recommended as the drug of~     first choice in the Dutch handbooks of palliative care. As a consequence of an adaptation of~     a Dutch law (July 2007) about off-label medication prescription, off-label medication is not~     allowed anymore unless a standard or protocol exists. No clinical trials for this patient~     group have been published before.~      Objective: To compare efficacy, side effects and costs of a strategy with amitriptyline as~     drug of first choice versus a strategy with pregabalin as drug of first choice.~      Study design: An open label, randomised non-inferiority trial Study population: Incurable~     cancer patients with neuropathic pain Intervention: When a patient decides to take part in~     the study, he will be allocated randomly to one of the two study groups. A minimisation~     algorithm will be used, that balances for the cause of neuropathic pain (tumour related~     versus treatment related), type of treatment (ongoing chemo- or radiotherapy versus not~     ongoing chemo- or radiotherapy) and institution. Each drug will be prescribed in a step up~     procedure. Patients will be followed during 8 weeks.~      Main study parameters/endpoints: Neuropathic pain, as measured with the mean VAS and McGill~     questionnaire, strategy success, costs per strategy, side effects, quality of life and~     concomitant analgesic drugs.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: There are hardly any risks for the patients. The drugs in both arms already are~     usual care for the target population. If there is no or a too small effect, the drug of the~     other arm will be added, which strategy also is already usual care. All other medication,~     except for Tricyclic Antidepressants Drugs (TADs) and Anti Epileptic Drugs (AEDs), as well as~     radiotherapy and chemotherapy are allowed. The patient has to visit the hospital 2 times~     during the study period. The patient had to fill in a pain diary daily (5 min), cost diary~     and EQ-5D every other week (10 min), related questionnaires as HADS, McGill and EORTC-QLQ-C30~     monthly (20 min).~   "
215372|NCT00740558|"~     Background~      The purpose of this study was to examine the heart rate variability (HRV) in the presence or~     the absence of pain in the lower back (L5), while receiving chiropractic care.~      Methods~      A total of 53 healthy participants were randomly assigned to a control, 2 treatment or 2 sham~     groups (n = 10 per group). Participants underwent an eight-minute acclimatizing period. The~     HRV tachygram (RR interval) data were recorded directly into a Suunto watch (model T6). The~     investigators analyzed the five minute pre-treatment and post treatments intervals. The~     spectral analysis of the tachygram was performed with the Kubios Software (University of~     Kuopio, Finland).~   "
215373|NCT00740545|"~     Standard investigations fail to reveal any apparent cause in 50% of the cases of recurrent~     spontaneous abortion. Prothrombotic mechanisms were initially evoked. Factor V Leiden,~     Prothrombin G20210A mutation and protein S deficiency are implicated in the meta-analysis of~     Rey (Lancet).However, they do not account for a large number of miscarriages.Gris JC and~     coworkers (Blood 2004)carried out an open trial, low-molecular-weight heparin versus low-dose~     aspirin, in women with one fetal loss and with a constitutional thrombophilic disorder. They~     conclude for a benefit action of Low-molecular-weight heparin. There is actually no trials~     concerning women with unexplained recurrent abortions and without known thrombophilia.~     Nevertheless,aspirin or enoxaparin are often prescribed. It is time to assess these~     practices. We therefore initiate a multisite, double blind randomized study, enoxaparine~     versus placebo, in women without known thrombophilia, which experienced unexplained recurrent~     abortions.~   "
215374|NCT00740532|"~     Aim of the study is to assess the impact on response to Herceptin-based therapy in patients~     with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for~     several biological factors potentially involved in Herceptin sensitivity.~      Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET,~     IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN,~     KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.~   "
215375|NCT00740519|"~     This study is conducted in Europe. The main objective of the study is to assess the safety of~     self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin~     for the first time. The study will also look at the blood glucose control, frequency of dose~     adjustment, clinic visits, and time spent training patients to self-titrate.~      The objective of diabetes management is to achieve blood glucose levels as close as possible~     to normal in order to avoid late stage diabetic complications. Self-titration (where patients~     adjust insulin dosage themselves) offers the potential for better blood glucose control than~     titration only at clinic visits. In recent years treatment of type 2 diabetes in the United~     Kingdom has moved from hospitals to GP surgeries or local clinics. Patients with type 2~     diabetes, in general, have not been trained in self-titration to the same degree as patients~     with type 1 diabetes. Less experience in self-titration could impact the level of blood~     glucose control and outcome for these patients.~      Data from this study will be pooled with data from NN304-3714 (NCT00825643) and will be~     reported in the final study report for NN304-3714.~   "
215376|NCT00740506|"~     This study, conducted at the Naval Medical Center in San Diego, CA, will determine if having~     vaginal intercourse in the last weeks of pregnancy decreases the risk of having a prolonged~     pregnancy. Pregnancies that continue beyond the due date may increase health risks for the~     mother and the baby. Although some believe that vaginal intercourse can help start labor in~     the last weeks of pregnancy, there is not proof that it works. Some studies showed that~     sexual intercourse helped and some that pregnancy lasted even longer for couples having sex.~     In addition to exploring the effect of sexual intercourse on time to delivery, this study~     will collect information that can be used in the future to predict when labor will naturally~     start and the risk for overdue pregnancies.~      Women 18 years of age and older in their first pregnancy who are carrying a single fetus with~     gestational age before 38 plus 6 weeks may be eligible for this study. Candidates must be~     living with their partner in a stable relationship.~      Participants are asked to have sexual intercourse about three times per week. They complete a~     diary in which they record the times they have intercourse and how they are feeling daily.~     The diaries are submitted by mail each week or at the doctor's or midwife's visit until~     delivery. The women have a pelvic exam and ultrasound and complete questionnaires about~     problems during pregnancy, overall well-being, attitude toward induction of labor, physical~     activity, body image during pregnancy, stress and social support, habits at home, and~     environmental conditions, such as weather.~   "
215377|NCT00740493|"~     In a French multicenter double blind randomized controlled trial, the main objective is to~     demonstrate that, after 6 months of oral anticoagulation for a first episode of idiopathic~     proximal deep vein thrombosis, 18 months of warfarin therapy is associated with a lower~     cumulative risk of recurrent VTE and major bleeding in comparison with that on 18 months of~     placebo. The secondary objectives are: (1) to determine the risk of recurrent VTE after 6~     months of warfarin therapy and the presence or the absence of residual lung scan perfusion~     defect and the persistence or not of elevated D-dimer test; and (2), to determine the impact~     of extended duration of anticoagulation on the risk of VTE after stopping anticoagulant~     therapy on a follow-up of 2 years.~   "
215378|NCT00740480|"~     The purpose of this research study is to learn more about the ENTact™ Septal Staple System~     device performance and to collect information to support its premarket application.~   "
215379|NCT00740467|"~     RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together~     with antithymocyte globulin before a donor stem cell transplant helps stop the growth of~     cancer and abnormal cells. Giving chemotherapy before or after transplant also stops the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer and abnormal cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving cyclosporine and mycophenolate~     mofetil after the transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well stem cell transplant works in treating~     patients with hematological cancer or other disorders.~   "
215380|NCT00740454|"~     The objective of the EDVIGE study is to determine whether a negative single distal and~     proximal leg veins compression ultrasonography safely rules out the diagnosis of deep vein~     thrombosis in pregnant and post-partum women with clinical suspicion of DVT.~   "
215381|NCT00740441|"~     The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal~     Cell Carcinoma~   "
215382|NCT00740428|"~     Urinary incontinence is any involuntary loss of urine. During gestation, hormonal and~     mechanical factors favor the incidence of urinary loss that may persist after delivery in up~     to 50% of women. Gestational urine loss can be prevented or treated during pregnancy with~     physical therapy. Pregnancy and delivery have been widely deemed important risk factors that~     should be assessed while developing preventive and curative treatments for both female~     urinary incontinence and pelvic floor muscle dysfunction. Pelvic floor muscle exercises, led~     by skilled physical therapists, can prevent, reduce, or even cure involuntary urine loss as~     well as pelvic floor muscle dysfunction. Within this framework, developing a low-cost,~     easy-to-perform method for the treatment of urinary incontinence and pelvic floor muscle~     dysfunction, with a preventive or curative approach, is considered necessary. The overall~     objective of this study is to assess the effects of pelvic floor exercises during pregnancy~     on pelvic floor muscles and urinary continence. Secondary aims include determining whether~     exercises change pelvic floor muscle function; if changing pelvic floor muscle function~     reduces the occurrence of urinary incontinence; developing and applying a manual guide; and~     determining whether the physical therapy guide is well accepted, easily understandable and~     reproducible.~   "
215383|NCT00740415|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, dexamethasone, and~     chlorambucil, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving combination chemotherapy together with~     rituximab and bortezomib may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with bortezomib,~     doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older~     patients with stage II, stage III, or stage IV mantle cell lymphoma.~   "
215384|NCT00740402|"~     The purpose of this study is to investigate the process of acquiring a motor skill subject in~     post-stroke, comparing them with healthy subjects.~   "
215385|NCT00740389|"~     This is a Phase I, open-label, 3-period crossover trial to investigate the pharmacokinetic~     interaction (process by which a drug is absorbed, distributed, metabolised and eliminated by~     the body) between TMC125 and fluconazole, and between TMC125 and voriconazole.~   "
215386|NCT00740376|"~     The purpose of this study is to demonstrate that the Uniglide™ Mobile Bearing Unicondylar~     Knee System (investigational device)is not inferior when compared to the Uniglide™ Fixed~     Bearing Unicondylar Knee System (control device currently cleared) as measured by the~     Composite Clinical Success (CCS) endpoint.~   "
215491|NCT00738959|"~     This study will be performed to evaluate the safety, tolerability and pharmacokinetics of~     single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male~     volunteers.~   "
215387|NCT00740363|"~     The major cause of premature death in renal transplant recipients is cardiovascular disease.~     Sitagliptin stimulates insulin secretion and inhibits glucagon release, two central~     mechanisms in PTDM by interaction with a hormone system (incretins) that just recently it has~     become possible to modulate by drugs. Sitagliptin therefore is an interesting additional drug~     for the treatment of posttransplant diabetes mellitus in transplanted patients.~      The primary objective of the present study is to investigate the effect of sitagliptin on~     insulin secretion in renal transplant recipients.~      Secondary objectives are to study the effect on insulin sensitivity, fasting blood glucose,~     endothelial function, CsA/Tac blood concentrations.~   "
215388|NCT00740350|"~     The purpose of this study is to determine if women who have chiropractic care, according to~     the Logan Basic Protocol for adjusting, during pregnancy have an easier, shorter labor and~     delivery as compared to women who haven't had chiropractic care during pregnancy.~   "
215389|NCT00740337|"~     Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death in the~     United States. There is no cure and the disease gets worse over time. Although it usually~     occurs in people who smoke cigarettes, researchers do not know exactly how smoking leads to~     COPD. This study will compare blood and tissue samples from smokers and nonsmokers with and~     without COPD to determine why some COPD symptoms occur in some people and not others.~   "
215390|NCT00740324|"~     The purpose of this study is to evaluate the safety and efficacy of the additional~     administration of scopolamine butylbromide, glucagon or NPO-11 following a single~     intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be~     evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 +~     scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The~     efficacy will be evaluated based on changes in the frequency of gastric peristalsis~     classification after the initial dose and the additional dose, and on the presence or absence~     of gastric peristalsis at each evaluation point.~   "
215391|NCT00740311|"~     After a dental extraction, the osseous alveoli fill naturally of a blood clot which is~     transformed some month later into osseous tissues. Even if the alveolar walls remain intact~     at the end of the intervention, the healing always comes along with a physiological reduction~     at the level of the site. The reduction of the alveolar crests is a continuous, cumulative~     and inexorable phenomenon This reduction entails in the long term aesthetic and functional~     damages which complicate the prosthetic rehabilitation of the dental articulate. That the~     prosthetic rehabilitation is removable or fixed, implanto-carried or not, it is made more~     difficult and less comfortable for the patient. In oral surgery, certain pathologies require~     for their treatment the use of materials of filling generating an activity of reduction /~     osseous replacement ending in the formation of a physiological calcified neo-tissue. Numerous~     products of osseous replacement were already used to realize alveolar fillings to avoid this~     inevitable and strongly harmful osseous loss.The purpose of the present study is to quantify~     the physiological osseous loss due to the dental extraction with or without filling by a~     randomized study and with calibrated criteria of evaluation. The current standard of care is~     no filling (healing from the blood clot) and we know the consecutive osseous loss during the~     aging. The technique by filling with an osseous substitute is more and more used in Europe~     and in Asia because of the decrease of the osseous loss. At first, these substitutes were~     constituted by bone grafts (autografts, allografts, xenografts) that tend to be replaced by~     synthetic materials. To realize these fillings according to countries, various materials are~     used (bovine bone, coral, bio glasses, phosphates of calcium). The most used synthetic~     materials are calcium ortho phosphates, the composition of which is close to mineral phases~     of calcified tissues. Ceramic of phosphate of calcium and more particularly the Biphasic~     Phosphate Calcium (BCP) was already used in numerous clinical applications.We chose as this~     study MBCP gel ™, same product beforehand used in 2 clinical studies for which the Nantes~     University Hospital was the sponsor.The perspectives of this study are to be able to propose~     the systematization of the alveolar filling to be able to decrease the osseous reduction~     after an extraction and to be able to propose more functional prosthetic rehabilitation~     (improvement of the masticatory power), more aesthetic and comfortable. When we know the~     effect of the under nutrition due to masticator difficulties notably at the aged persons, we~     measure all the importance of this major problem of Public health.~   "
215392|NCT00740298|"~     Newborns routinely experience pain associated with invasive procedures such as blood~     sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an~     ethical expectation and a professional imperative, as untreated pain has deleterious~     consequences including altered pain sensitivity in later childhood and may be related to the~     permanent neuroanatomical and behavioral abnormalities as found in animal models. Moreover,~     pain is a source of concern and distress for new parents. Yet, pain reducing therapies are~     often underused for the numerous minor procedures that are a part of routine medical and~     nursing care for neonates. Growing scientific and clinical literature provides evidence for~     the effectiveness of natural, non-pharmacological techniques in both animal and human~     newborns. This study compares the pain reliving effects of sweet taste to the combination of~     sweet taste and warmth.~   "
215393|NCT00740285|"~     Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally~     classified as one of the autoimmune rheumatic diseases. The disease is characterized by~     thickening and fibrosis skin, affecting vessels and many organs such as the esophagus,~     stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still~     unknown, but scientists and medical investigators in a wide variety of fields are working~     hard to make those determinations. It is known that scleroderma involves overproduction of~     collagen.~      FLICKMAN et al, in 1973 published an article about the role of lidocaine at~     prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production.~     Until now, there is only a case series showing the improvement of thickening skin (75%) and~     esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a~     RCT to prove these findings.~   "
215394|NCT00740272|"~     The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients~     presenting a brady-tachy syndrome on the AF burden.~      The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence~     but also from bradycardic episodes.~   "
215395|NCT00740259|"~     Flunarizine is a calcium channel blocker traditionally used for the treatment of vertigo and~     migraine. It also has the mechanism of action associated with antipsychotic activity (D2~     receptor blockade), but has never been tested as such. The investigators hypothesis is that~     flunarizine can be an atypical antipsychotic.~   "
215396|NCT00740246|"~     The objective of this study is to evaluate the safety and tolerability of VIT-45 in the~     treatment of Iron Deficiency Anemia~   "
215442|NCT00739622|"~     The purpose of this study is to investigate the pharmacokinetic interaction between the~     combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily.~     Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body~     and eliminated from the body. Furthermore the short-term safety and tolerability (how well~     the body tolerates the drug) of co-administration of TMC278 and ethinylestradiol and~     norethindrone, in healthy women, will be assessed.~   "
232574|NCT00511953|"~     Depomed's Gabapentin Extended Release is an investigational, extended release formulation of~     gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.~   "
215397|NCT00740233|"~     The investigators are inviting people with fibromyalgia, IBS, interstitial cystitis, chronic~     pain, and other chronic and recurring conditions to sign up and participate in a year-long~     Internet-based survey to study the effectiveness of alternative medicine and the interactions~     among stress and coping, pain, and treatment outcomes.~      The survey is called PROCAIM, which stands for Patient-Reported Outcomes from Complementary,~     Alternative, and Integrative Medicine. PROCAIM was developed under a grant to UCLA~     researchers from the National Center for Complementary and Alternative Medicine.~      This is a web-based study composed of surveys that will recur at intervals over 1 year!~      TO ENROLL~        -  Log in to our web site: http://www.procaim.org/~        -  Register as a New User.~        -  Select clinic name: ClinicalTrials.gov.~        -  Read and sign the Consent Form.~      After participantssign the form with their email address, participants can begin to answer~     the first in a series of questionnaires. The system will send participants email reminders at~     the time of each scheduled follow-up for one year.~      For further information about PROCAIM, please contact:~        -  Deborah Ackerman, Ph.D.~        -  Department of Epidemiology~        -  UCLA School of Public Health~        -  Box 951772~        -  Los Angeles, CA 90095-1772~        -  deborah.ackerman@ucla.edu~   "
215398|NCT00740220|"~     This trial will test the hypothesis that the 6 minute walk test (6MWT) is not reproducible as~     a measure for oxygen desaturation.~   "
215399|NCT00740207|"~     The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and~     pain following intraarterial injection for peripheral DSA.~   "
215400|NCT00740194|"~     Aromatase inhibition versus estradiol during 1 week~   "
215401|NCT00740181|"~     This study will determine the activity of decitabine, low dose cytarabine (ARA-C) and G-CSF~     for patients with myelodysplasia and leukemia.~   "
215402|NCT00740168|"~     Bevacizumab might influence the dynamic vessel function after being administered~     intravenously.~   "
215403|NCT00740155|"~     This is part of an ongoing effort to develop a satisfactory dengue vaccine:~      Primary objective:~      To describe the safety after each vaccination with bivalent and tetravalent formulations of~     dengue vaccine candidates.~      To describe the immune response after each vaccination of dengue vaccine.~   "
215404|NCT00740142|"~     Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious~     than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized,~     double-blinded, placebo controlled trial~   "
215405|NCT00740129|"~     The purpose of this study is to demonstrate that patients with Paget's disease of the bone~     who had responded to zoledronic acid treatment as participants in the core registration~     studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully~     treated with a 5mg infusion of zoledronic acid.~   "
215406|NCT00740116|"~     The purpose of the study is to determine if a standardized single dose tranexamic acid given~     intravenously immediately preoperatively reduces the perioperative bleeding volume and~     reduces the need of blood transfusion in women undergoing surgery for advanced ovarian~     cancer.~   "
215407|NCT00740103|"~     CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients~     are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary~     objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease~     in Crohn's Disease Activity Index (CDAI).~   "
215408|NCT00740090|"~     This study will evaluate the safety and immune response of children to an experimental~     malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an~     infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by~     certain kinds of mosquitoes. It affects at least 300 million people worldwide each year, with~     more than 1 million deaths, mostly among children less than 5 years of age in sub-Saharan~     Africa. Malaria is the leading cause of death and illness among the general population of~     Mali in West Africa. Increasing drug resistance to P. falciparum and widespread resistance of~     mosquitoes to pesticides are reducing the ability to control the disease through these~     strategies. AMA1 C1 is made from a synthetic protein similar to a P. falciparum protein. It~     is combined with Alhydrogel and CPG 7909, substances added to vaccines to make them work~     better.~      Children between 1 and 4 years of age who live in Bancoumana, Mali, and are in general good~     health may be eligible for this study. Candidates are screened with a medical history,~     physical examination, and blood and urine tests.~      Participants are randomly assigned to receive three injections (shots) of either AMA1-C1 or a~     control rabies inactivated vaccine called Imovax® (Registered Trademark). The shots are given~     in the thigh muscle on study days 0, 56 and 180. After each shot, participants are observed~     in the clinic for 30 minutes. They return to the clinic for a physical examination six or~     seven times between each shot and then four more times over a 9-month period after the last~     shot. Blood samples are drawn at several of these visits to check for side effects of the~     vaccine and to measure the response to it. The total duration of the study is 21 months.~   "
215409|NCT00740077|"~     This is a single-dose, pharmacokinetic study investigating the bioavailability of flavonoids~     and phenolic acids from cranberry juice cocktail and their breakdown products (in vivo~     metabolites) in healthy, older adults. Our hypothesis is that the compounds will be poorly~     but rapidly absorbed from the intestines and found in plasma and urine in extensively~     metabolized forms. These compounds will be rapidly cleared from plasma. Substantial amounts~     of unabsorbed compounds will be found in the stools.~   "
215410|NCT00740064|"~     To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive~     HIV-infected subjects.~   "
215411|NCT00740051|"~     Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is~     inappropriate (intolerability, contraindication). The second part of the study looks at the~     safety of BI 1356 in this patient population with longer term treatment in comparison to a~     sulfonylurea drug (glimepiride)~   "
215443|NCT00739609|"~     This study provides an early evaluation of an entirely new class of small molecule agents~     directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be~     involved in the growth of many solid tumors.~   "
215444|NCT00739596|"~     The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination~     of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.~   "
244754|NCT00350337|"~     This descriptive study will evaluate the safety and immunogenicity of 3 different~     formulations of the WRAIR dengue vaccine compared to a placebo.~   "
215412|NCT00740038|"~     Chemotherapy adversely affects quality of life in cancer patients. Both stress management~     training and exercise training have been shown to improve quality of life. These two types of~     training have not been directly compared for chemotherapy patients.~      This study seeks to evaluate the separate and combined effects of stress management training~     and exercise training on quality of life during chemotherapy treatment. Participants receive~     either a home-based, self-administered program in 1 of 3 types (stress management, exercise,~     or stress management + exercise) or usual care (reading materials). It is hypothesized that~     the combined program (stress management + exercise) will be significantly associated with~     better quality of life than the usual care group, the exercise only group, and the stress~     management only group. All participants are assessed at 3 timepoints: before they begin~     chemotherapy, 6 weeks after their first chemotherapy infusion, and 12 weeks after their first~     infusion.~   "
215413|NCT00740025|"~     This is a prospective randomized study evaluating dosing frequency of gonadotropin~     administration in ART cycles.~   "
215414|NCT00740012|"~     Study hypothesis: Waking up in response to an alarm clock may evoke a stress reaction that~     leads to rising glucose concentrations.~      The purpose of this study was to prove this hypothesis with continuous glucose monitoring~     over three nights.~      Night (a) with an alarm clock set at 2 h intervals for glucose self monitoring,~      Night (b) with a nurse performing blood glucose determinations, and~      Night (c) with the patients left undisturbed.~   "
215415|NCT00739999|"~     To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in~     children and adolescents with heterozygous familial hypercholesterolemia~   "
215416|NCT00739986|"~     Assessment of the number of days' treatment with semapimod necessary for efficacy, as~     measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to~     severe Crohn's disease (CD).~   "
215417|NCT00739973|"~     Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in~     combination with amlodipine in patients with essential hypertension.~   "
215418|NCT00739960|"~     The purpose of this study is to determine how safe and effective Abatacept is in treating~     patients who have progressive pulmonary sarcoidosis.~   "
215419|NCT00739947|"~     This is an observational study that involves subjects with full-thickness rotator cuff tears~     treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The~     primary objective of this study is to observe the timing and rate of tendon retear in those~     subjects.~   "
215420|NCT00739934|"~     In this study we will measure the concentration of the drug called voriconazole which is used~     to fight infections caused by fungus in children who usually are cancer patients and have~     their immune system down. Since we know the dose in adults, and we think we know the matching~     doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that~     goes into the system with what we know works in adults. We give the drug by a needle directly~     into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we~     draw a little bit of blood at certain times to measure the drug in it.~   "
215421|NCT00739921|"~     The objective of this study is to determine whether the amount or type of fungal DNA present~     in the nose and home environment can be correlated with the outcomes of the following quality~     of life (QOL) instruments: Medical Outcomes Study 36-item Short Form (SF-36) and the~     Sino-Nasal Outcomes Study - 20 Questions (SNOT-20).~   "
215422|NCT00739908|"~     The purpose of this study is to examine the efficacy of CX157 60 mg administered three times~     a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder~     (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state~     pharmacokinetic profile of CX157 in these subjects.~   "
215423|NCT00739895|"~     Cardiovascular magnetic resonance (CMR) imaging will be used to assess the impact of common~     colds and physical training in high-performing athletes. Healthy individuals from the general~     public will serve as a comparison group. CMR has previously been shown to accurately assess~     cardiac function, edema, inflammation, and injury.~      Athletes competing at National level and Developmental Canadian teams will be prospectively~     recruited. All participants will have CMR scans at low and high intensity training.~     Participants will be re-scanned immediately after clinical evidence of a common cold, as~     determined by respiratory and flu-like symptoms. After 4 weeks, a follow-up CMR scan will be~     performed. On the day of each CMR scan, electrocardiograms and blood samples will be drawn~     from each participant. Blood samples will provide markers of systemic inflammation, such as~     leukocyte counts. At each CMR scan, athletes will be asked to describe there recent history~     of physical exertion in questionnaires, which will reflect the degree of physical exertion~     performed.~   "
215424|NCT00739882|"~     To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic~     moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's~     Global Assessment (PGA - H&F) greater-than or equal to 3 in subjects not suitable for other~     systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A~     (PUVA).~   "
215425|NCT00739869|"~     A silent stroke is a type of stroke that does not produce any severe symptoms, but may~     slightly affect memory or thinking abilities. Women who take hormone replacement therapy~     (HRT) may have a higher risk of experiencing a silent stroke than women who do not use HRT.~     This study will use magnetic resonance imaging (MRI) to determine the prevalence of silent~     strokes and other changes in brain tissue in women who participated in the Women's Health~     Initiative Memory Study (WHIMS), a study in which women received HRT, either as estrogen~     alone or as estrogen and progesterone combined, or placebo.~   "
215426|NCT00739856|"~     Post Traumatic Stress Disorder is a chronic debilitating illness and few treatment options~     have demonstrated effectiveness. The study will look at the use of electroconvulsive therapy~     for the treatment of Post Traumatic Stress disorder in patients who have not responded to~     multiple antidepressants or cognitive behavioral therapy.~   "
215427|NCT00739843|"~     The purpose of this study is to estimate how quickly cognitive status and functional status~     in older patients on hemodialysis declines.~   "
215428|NCT00739830|"~     The purpose of this study is to compare progression-free survival (PFS) of patients with~     advanced, recurrent or metastatic endometrial cancer who have received one, but not more than~     two, prior lines of chemotherapy either as adjuvant therapy or treatment for advanced~     disease, and then when treated with ridaforolimus or the investigators' choice of progestin~     or chemotherapy.~   "
215429|NCT00739817|"~     Background: Primary ciliary dyskinesia (PCD) is a rare genetic disease characterised by~     recurrent respiratory infections and subfertility due to dysfunction of cilia (brushes) of~     the lining cells. Undiagnosed and untreated it can result in an irreversible crippling~     chronic lung disease. The diagnosis of PCD is a difficult one and involves the complex~     assessment of ciliary structure and function. Thus, PCD is under diagnosed and appropriate~     preventative and symptomatic treatment may be denied in many patients. In addition, the gene~     responsible for PCD is at present unknown, thus preventing pre-natal diagnosis and genetic~     counseling.~      Working hypothesis and aims: Recently, it has become apparent that the evaluation of nasally~     expired nitric oxide (NO) constitutes a simple and non-invasive diagnostic method, which~     discriminates between PCD patients, PCD carriers and healthy controls at high rate of~     specificity and sensitivity. Testing is simple and last approximately one minute. We have~     recently identified a unique isolated Druze population with high prevalence of PCD. The high~     frequency of disease places this closed community at a high risk of undiagnosed PCD.~      The aim of this project is to use nasal NO measurement as a screening tool to identify~     possible undiagnosed cases of PCD and PCD carriers in this high risk Druze population.~   "
215430|NCT00739791|"~     RATIONALE: Learning about changes in DNA over time in patients with prostate cancer~     undergoing diet and lifestyle changes may help doctors learn about the long-term effects of~     these changes on disease progression.~      PURPOSE: This clinical trial is studying nutrition and lifestyle changes in patients with~     previously untreated stage I or stage II prostate cancer.~   "
215431|NCT00739778|"~     Bacteria that live in the mouth can digest fermentable carbohydrates such as sucrose,~     fructose, and glucose to make acid. This acid can cause demineralization of the tooth and~     lead to dental caries or decay. Noncariogenic carbohydrate sweeteners, such as sugar~     alcohols, can be used to replace fermentable carbohydrates in foods, thereby decreasing the~     risk of caries. In order for a sweetener to be labeled as a noncariogenic sweetener, the FDA~     requires that when present in food, the food should not lower the dental plaque pH below 5.7~     either during or up to 30 minutes after consumption. The purpose of this study is to~     determine whether a new developmental sweetener can be fermented by the bacteria in the mouth~     and lead to acid production. This will be done by measuring the pH of dental plaque following~     consumption of the sweetener.~   "
215432|NCT00739765|"~     This study will examine whether interpersonal psychotherapy is as effective in treating~     post-traumatic stress disorder as the established therapies of prolonged exposure and~     relaxation.~   "
215433|NCT00739752|"~     The goal of this study is to evaluate two sets of interventions to increase acceptance of~     hepatitis B virus (HBV) vaccination in patients attending sexually transmitted disease (STD)~     clinics. The 1st set of interventions, with 3 levels, is based on message framing. The 3~     levels are: 1. information only; 2. gain-framed message; and 3. loss-framed message. The 2nd~     set of interventions, with 2 levels, involves how the vaccine is recommended by the health~     care provider. The 2 levels are: 1. HBV vaccine offered; and 2. HBV vaccine recommended. The~     outcome of interest is1st dose acceptance.~   "
215434|NCT00739739|"~     The purpose of this study is to determine whether PD 0299685 is effective in the treatment of~     symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain,~     urinary urgency and frequency. At the same time assess the drug's safety and tolerability.~   "
215435|NCT00739713|"~     The objective is to study the effect of sea buckthorn oil on dry eye.~   "
215436|NCT00739700|"~     Blood pressure cuffs (NIBP) are slowly replacing intra-arterial (IABP) measurement as the~     standard of care in the medical intensive care unit. There is little data to support this~     clinical normalization of deviance. This study aims to correlate NIBP with IABP.~   "
215437|NCT00739687|"~     Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a~     role in the development and progression of heart failure. The AGE-crosslink breaker~     Alagebrium improved cardiac function and symptoms in experimental preclinical and small human~     heart failure studies. These results have not yet been confirmed in a randomized controlled~     clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects~     diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to~     assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100~     subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures:~     exercise testing (VO2 max; the primary variable), ECGs and blood sampling.~   "
215438|NCT00739674|"~     To evaluate the effectiveness of diet management with a losartan based titration regimen~     versus losartan based titration regimen alone on blood pressure reduction in hypertensive~     patients.~   "
215439|NCT00739661|"~     The study was a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical~     trial of vismodegib (GDC-0449) in patients with ovarian cancer in a second or third complete~     remission. Patients were randomized in a 1:1 ratio to either vismodegib or placebo.~     Randomization was stratified based on whether their cancer was in a second or third complete~     remission.~   "
215440|NCT00739648|"~     Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent~     acute exacerbations (AECB) which are associated with enormous healthcare expenditures and~     significant morbidity, specifically an increased risk of death, a decline in pulmonary~     function and a significant change in quality of life. Bacteria appear to have an important~     role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in~     COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In~     addition, recent studies indicate that acquisition of a new strain of H. influenzae, M.~     catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations.~     Chronic inflammation and bacterial infection predispose many patients to frequent and~     recurrent acute exacerbations.~      Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will~     decrease the incidence of acute exacerbations by both by lowering the organism burden, and~     resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial~     strains.~   "
215441|NCT00739635|"~     The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in~     the treatment of subjective tinnitus in comparison to placebo.~   "
215521|NCT00738569|"~     The purpose of this study is to determine whether or not adding Raltegravir to a fully~     suppressive antiretroviral regimen will assist in reducing HIV-1 associated chronic~     inflammation and increase the t-lymphocyte memory cell pool.~   "
215445|NCT00739583|"~     Skin preparation solutions are used to clean the skin of the patient before surgery to~     decrease the rate of infection. This is particularly important for hip replacement to reduce~     the risk of prosthetic joint infection. The use of a mark on the skin for site identification~     has become the standard of care to decrease wrong site surgery. The Joint Commission has~     mandated site identification as part of the surgical time-out. This procedure is also~     mandated by hospital policy.~      Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark~     used for surgical site identification. Erasure of the mark presents the surgeon with~     difficulty in performing the site identification. Any error or lack of visualization of the~     site marking could lead to catastrophic wrong site surgery.~      The investigators hypothesis is that chlorhexidine based skin preparation solutions erase~     site marking in comparison to iodine based skin preparation solutions. The investigators~     intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients~     will be randomized to either a chlorhexidine based or an iodine based skin preparation~     solution. These solutions are both the current gold standard of clinical care. No differences~     have been shown in infection rates for total hip arthroplasty between these solutions. The~     site marking will be performed by the same surgeon in a standardized manner. The site marking~     will include the surgeon's three initials as per usual routine. Underneath the initials three~     random initials will be placed with a horizontal line drawn underneath. The preparation of~     the skin will be performed according to the manufacturer's specifications. Digital~     photographs will be taken of the skin marking after skin preparation. Photographs of the~     three random initials will be de-identified and placed in a Powerpoint presentation form.~     Ten orthopaedic surgeons will then read the site markings to identify the random initials and~     to tell whether the mark looks appropriate to perform a surgical timeout. The horizontal line~     will be digitally analyzed using Adobe Photoshop to quantitatively measure blackness of the~     mark.~   "
215446|NCT00739570|"~     1. Evaluation of the effect of a chiropractic adjustment (Manually Assisted Mechanical~          Force)on~        2. surface Static EMG~        3. Paraspinal cutaneous temperature~        4. Range of Motion~        5. Dynamic EMG~        6. Blood hormones (Interleukin-6 and C-Reactive protein)~   "
215447|NCT00739557|"~     The purpose of this study is to look at the systemic inflammatory response caused when~     patients undergo thoracoabdominal aortic aneurysm repair (TAAA). In addition, this study will~     look at how the inflammatory response affects the post operative healing process and post~     operative complications.~   "
215448|NCT00739544|"~     The purpose of this study is to identify intraindividual as well as iatrogenic factors~     disposing for the development of chronic and acute pains after surgery for breast cancer in~     order to improve treatment and prevent the development of acute and chronic postoperative~     pains.~   "
215449|NCT00739531|"~     Collection of quantitative data to demonstrate the accuracy (bias) and precision~     (repeatability) of the Apieron INSIGHT(tm) eNO Breath System as compared to the FDA cleared~     NIOX eNO Breath System when testing is performed by asthma patients.~   "
215450|NCT00739518|"~     This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as~     new hardware or software designed to improve MRI examinations of the brain, spine head and~     neck regions.~   "
215451|NCT00739505|"~     This clinical trial studies the safety, tolerability, and pharmacology of asfotase alfa when~     given to adults with HPP.~   "
215452|NCT00739492|"~     In the pilot study, Testing Strategies for Weight Loss, we tested two different approaches~     using financial incentives to encourage weight loss. In the first, we built on previous work~     showing the effectiveness of 'deposit contracts', in which subjects are given the opportunity~     to put their own money at risk if they do not lose weight. In this incentive condition,~     subjects received a direct payment conditional on daily weight loss, and an optional~     additional payment based on their own contributions to the deposit contract. We matched their~     contribution 1:1 to make the option of depositing their own money attractive to this~     predominantly low SES population. In the second approach we built on our own prior work using~     lotteries to promote drug adherence. In this incentive condition, participants are entered~     into a daily lottery, and receive any payoffs they earn from the lottery only if they stay on~     track with their weight-loss goal. Given their popularity in the general population,~     lotteries hold the promise of providing a cost-effective means of motivating weight loss and~     making efforts to lose weight more salient to obese patients. Results from this trial~     indicate significantly higher weight loss in the incentive arms of the trial than in the~     control group. The low lost to follow-up rates suggest that this approach to providing daily~     feedback to keep weight loss salient among participants is feasible. Incentive participants~     who completed the study called in their daily weights an average 95.8% of the time. 17/19~     (89.4%) of subjects deposited money in their deposit contracts and 14/17 participants who~     made initial deposits either held constant or increased their contributions each month.~     Subjects in both incentive groups lost significantly more weight on average than subjects in~     the control group (4.0 lbs) (lottery 13.1 lbs, p = 0.015; deposit contract 14.0 lbs, p =~     0.003). Of the subjects not lost to follow-up in the two incentive arms (32 out of 38), all~     of them lost weight.~      Based on this promising preliminary evidence and supplemental funding from the Hewlett~     Foundation, we propose an 8-month study with 2 intervention arms to further examine the~     effect of incentives on long term weight loss success. This study will build on the work to~     date to examine which intervention is most successful in promoting sustained weight loss. The~     proposed 3-arm extension will enroll 66 participants from Philadelphia VA with BMIs between~     30 and 40, starting with those potential participants who were placed on a waiting list for~     our previous study after an overwhelming response to the initial mailing.~   "
215453|NCT00739479|"~     The aim of this study is to compare the effects of two different protein supplements~     (partially hydrolyzed whey protein, PHWP vs. partially hydrolyzed gelatin, PHG) on weight~     loss in obse individuals with metabolic syndrome (METS). These two supplements will contain~     equal amounts of protein but differ considerably in their amino acid contents. Whey protein~     is rich in essential amino acids whereas gelatin is rich in proline.~      In obese individuals with METS, the hypotheses are:~        -  PHWP will augment fat-mass loss and increase lean-mass to fat-mass ration more than PHG.~        -  PHWP will improve insulin action more than PHG.~        -  PHWP will decrease cardiovascular disease risk more than PHG.~   "
215454|NCT00739466|"~     The main objective of this study is to assess the safety and efficacy of Liposomal~     Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a~     population undergoing PCI with implantation of a bare metal stent.~      Study hypothesis: Liposomal Alendronate will reduce in-stent restenosis as compared to~     placebo.~   "
215455|NCT00739453|"~     Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum~     Tolerated Dose (MTD) of OSI-906 in combination with erlotinib~   "
215456|NCT00739440|"~     The purpose of this study is to compare the efficiency and safety of the treatment against~     sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum~   "
215457|NCT00739414|"~     This study will characterize the safety, tolerability, biological activity, and~     pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has~     progressed despite standard therapies, or for whom no standard therapy exists.~   "
215458|NCT00739401|"~     The use of a suprarenal extension device during the index AAA procedure to accommodate the~     patient's anatomy and to prevent or repair leakage.~   "
215459|NCT00739388|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with~     acute myeloid leukemia who are unsuitable for treatment with intensive chemotherapy.~   "
215460|NCT00739375|"~     Pulmonary hypertension (PHT) is an elevation of pulmonary arterial pressure (PAP) that can be~     the result of heart, lung or systemic disease. PHT also complicates chronic hemodialysis (HD)~     therapy immediately after the creation of an arteriovenous (AV) access, even before starting~     HD therapy. It tends to regress after temporary AV access closure and after successful kidney~     transplantation. Affected patients have significantly higher cardiac output. This syndrome is~     associated with a statistically significant survival disadvantage. The laboratory hallmark of~     this syndrome is reduced basal and stimulatory nitric oxide (NO) levels. It appears that~     patients with end-stage renal disease (ESRD) acquire endothelial dysfunction that reduces the~     ability of their pulmonary vessels to accommodate the AV access-mediated elevated cardiac~     output, exacerbating the PHT. Doppler echocardiographic screening of ESRD patients scheduled~     for HD therapy for the occurrence of PH is indicated. Early diagnosis enables timely~     intervention, currently limited to changing dialysis modality such as peritoneal dialysis or~     referring for kidney transplantation.An echocardiographic diagnosis of pulmonary hypertension~     (PHT) is made when the systolic pulmonary arterial pressure (PAP) exceeds normal values (30~     mmHg). In mild PHT, PAP values range up to 45 mmHg, in moderate PHT, PAP is between 45 and 65~     mmHg, and in severe PHT, PAP values are greater than 65 mmHg. Systolic PAP equals cardiac~     output times pulmonary vascular resistance (PVR), (i.e., PAP = cardiac output × PVR).~     Increased cardiac output by itself does not cause PH because of the enormous capacity of the~     pulmonary circulation to accommodate the increase in blood flow. Therefore development of PHT~     requires pathologic, marked elevation of pulmonary vascular resistance. The presence of PH~     may reflect serious pulmonary vascular disease, which can be progressive and fatal.~     Consequently, an accurate diagnosis of the cause of PHT is essential in order to establish an~     effective treatment program. Pulmonary hypertension can occur from diverse etiologies. In~     1996 we first noted unexplained PH in some long-term hemodialysis (HD) patients during an~     epidemiologic study of this disorder (Nakhoul F and Yigla M Rambam Medical Cemter-Haifa). It~     was assumed that their PHT was related to end-stage renal disease (ESRD) or to long-term HD~     therapy via an arteriovenous (AV) access.~      There are several potential explanations for the development of PHT in patients with ESRD.~     Hormonal and metabolic derangement associated with ESRD might lead to vasoconstriction of~     pulmonary vessels and increased pulmonary vascular resistance. Values of PAP may be further~     increased by high cardiac output resulting from the AV access itself, worsened by commonly~     occurring anemia and fluid overload. Despite almost five decades of HD therapy via a~     surgically created, often large, hemodynamically significant AV access the long-term impact~     of this intervention on the pulmonary circulation has received little attention.~      RD versus AV HD via AV access~      Proposed Mechanisms:~        1. Elevated Parathyroid hormone~        2. Metastatic Calcification due to the increase of the calcium-phosphor multiple~        3. High cardiac output~        4. Nitric oxide-endothelin metabolism~        5. A-v Access flow~      These observations indicate a role for AV access-mediated elevations in cardiac output in the~     pathogenesis of PH. The correlation between access flow and PAP values has not yet been~     studied. Since patients undergoing HD therapy via AV access had PH that reversed after~     successful kidney transplantation and after short AV access compression, we concluded that~     both ESRD and AV access-mediated elevated cardiac output are required for the development PH.~     From a physiologic point of view, due to the enormous capacity of the pulmonary~     microcirculation, increased cardiac output by itself cannot cause PH. It is the inability of~     the pulmonary circulation of some ESRD patients to accommodate the AV access-mediated~     elevated cardiac output that leads to the development of PH.~   "
215517|NCT00738621|"~     The purpose of this study is to compare the efficacy of the use of oral aprepitant in~     combination with intravenous ondansetron and dexamethasone with the efficacy provided by the~     use of oral aprepitant and dexamethasone for preventing vomiting during the first 24-48 hours~     after breast surgery.~   "
215461|NCT00739362|"~     This study will determine whether electrical stimulation of an area of the brain called the~     dorsolateral prefrontal cortex, which is important in determining the feeling of fullness~     after eating, affects how much food a person eats and weight loss over 4 weeks. It will also~     compare weight changes in people who attend weight loss counseling sessions and those who do~     not over this period of time.~      Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live~     in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a~     body mass index of 35 kg/m(2) or more and weigh less than 350 pounds.~      Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the~     study for tests, which include meal tests to determine eating behaviors and caloric intake,~     blood and urine tests, glucose tolerance test, weight measurement, psychological assessments~     and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their~     food from automated vending machines. Some subjects receive transcranial direct current~     stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the~     head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the~     electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly.~      After the evaluations, subjects are discharged home from the NIH unit and instructed to eat~     25 percent fewer calories than they consumed while on a weight maintenance diet the first 3~     days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks.~     During this period they come to the NIH unit 3 days a week to receive either real or sham~     TDCS.~   "
215462|NCT00739349|"~     Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine~     Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and~     symptoms of dry eye after a 3 month treatment period.~   "
215463|NCT00739336|"~     This worksite program for Onondaga County employees is a pilot research study aimed at~     decreasing the risk of developing diabetes (or improving metabolic control for adults with~     diabetes). The main goal is to improve the nutrition and physical habits of the participants,~     and promote weight loss in those who are overweight. The investigators will also examine~     factors that predict participation in the program and influence a participant's~     outcome/success in the program.~   "
215464|NCT00739323|"~     An observational study to gather information about people who may have certain abnormalities~     in skin microcirculation and muscle metabolism and to determine whether these abnormalities~     affect wound healing. The study also examines the association of a specific type of cell with~     the rate of wound healing.~   "
215465|NCT00739310|"~     To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of~     respiratory exacerbations requiring hospitalization or antibiotic utilization in patients~     with muscle weakness and restrictive lung disease.~   "
215466|NCT00739297|"~     This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast)~     compared to placebo on improved lung function in patients with chronic asthma.~   "
215467|NCT00739284|"~     Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying~     fever or renal failure, an urgent drainage might be needed. This can be done either by~     placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the~     question which of the two is preferred. A debate exist regarding the effectiveness of each~     procedure to improve symptoms, renal function and treating an infection. Our goal is to~     resolve this debate and to state whether one way is preferred on the other.~   "
215468|NCT00739271|"~     The concept of starting the patient on early enteral nutrition has been a topic of much~     interest and research in the past decade. It is gaining widespread acceptance worldwide as~     more and more studies are being conducted proving early enteral nutrition to be more~     physiological, to prevent morphologic and functional trauma related alterations of the gut~     and to modulate immune and inflammatory responses, and as being less expensive than total~     parenteral nutrition. Early enteral nutrition is a major component of the recently introduced~     post operative rehabilitative regimens.~      Early feeding has been shown to reduce the risk of any specific infection, mean length of~     hospital stay, anastomotic dehiscence, wound infection, pneumonia, intra abdominal abscesses.~     It leads to lower weight loss and early positive nitrogen balance. Hence, overall early~     enteral nutrition leads to reduced post operative morbidity and better patient outcome.~      The objective of this study was to study and compare the effects of early enteral feeding~     with those of conventional management in patients undergoing intestinal anastomosis; the end~     points being return of bowel activity, incidence of septic complications, length of hospital~     stay, weight loss and post operative morbidity.~   "
215469|NCT00739258|"~     It is difficult to detect the intestinal protozoal infections among the HIV-infected persons~     or travelers diarrhea by using the traditional microscopy or staining methods. The purpose of~     this study aimed at finding out the appropriate diagnostic methods and the infection rate of~     the intestinal protozoa, including the Entamoeba, Cryptosporidium and Giardia among the~     HIV-infected persons by using the antigen detection method and biological method. The~     investigators also tried to analyze the associated HIV infection status and sexual~     transmitted diseases (STD) including Gonorrhea, Chlamydial trachomatis, Syphilis, Genital~     warts and Herpes simplex virus in this study. The study will collect the blood, urine and~     stool samples from 200 intravenous drug user (IDU) with HIV-infected in the prisons, 400~     intravenous drug user (IDU) without HIV infected and 100 intravenous drug user (IDU) with HIV~     infected receiving methadone maintenance treatment.~   "
215470|NCT00739232|"~     This is a single ascending dose study of HSD-016 to provide the initial assessment of the~     safety, tolerability, how the drug is absorbed and eliminated, and its effect on the body.~   "
215471|NCT00739219|"~     This study is designed to show that pharmacotherapy guided by eNO and clinical standard of~     care produces a superior outcome to trial-based therapy guided by clinical standard of care~     alone.~   "
215472|NCT00739206|"~     The objective of the study is to assess the efficacy and safety of SAR97276A in severe~     malaria in pediatric patients. Before treating pediatric patients with severe malaria, the~     efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric~     patients, with uncomplicated malaria.~      The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult~     and pediatric patients.~   "
232575|NCT00511940|"~     The purpose of this research study is to determine the efficacy (how well it works),~     tolerability and safety of acomprosate compared with placebo in patients with binge eating~     disorder.~   "
215475|NCT00739167|"~     RATIONALE: Learning about quality of life in patients with cancer undergoing embolization may~     help doctors learn about the side effects of treatment and plan the best treatment.~      PURPOSE: This clinical trial is studying quality of life in patients undergoing embolization~     using yttrium Y 90 glass microspheres for primary or metastatic liver cancer.~   "
215476|NCT00739154|"~     since glaucoma is considered an optic neuropathy, new treatments for glaucoma are being~     continuously investigated, including neuroprotection.~      Previous studies implied that phenytoin, a potent anti-convulsive drug, has a neuroprotective~     role, and Na+ channels blockage was suggested as a possible mechanism.~      This study predicts that glaucoma patients taking Phenytoin will have a less advanced~     glaucoma as compared to patients not taking the drug. Glaucoma severity will be determined by~     visual acuity, visual fields, optic disc cupping and nerve fiber layer thickness~   "
215477|NCT00739141|"~     The traditional way of doing a donor transplant is to give high doses of chemotherapy and~     radiation before giving the stem cells. However, high doses of chemotherapy and radiation can~     have serious side-effects. The doctors think that the transplant will be safer and more~     likely to be successful with reduced doses of chemotherapy and radiation. The purpose of this~     study is to find out how good a combination of chemotherapy and radiation at reduced doses~     followed by a cord blood transplant are at treating cancer.~      The stem cells chosen for the transplant are from umbilical cord blood. Umbilical cord blood~     is collected from healthy newborn babies and frozen. One cord blood collection is called a~     cord blood unit. On transplant day, the cord blood will be given through the catheter just~     like a blood transfusion. Transplants done this way have been successful. However, this type~     of transplant is fairly new. Therefore, it is important to study it so the doctors can better~     understand how it works.~      Most blood or bone marrow transplants using donor stem cells are done as part of a study.~     When patients are on a study we test new ways of treating them which we think may be better~     than the old ways. We collect information about the result of this treatment so we can~     understand how well the treatment works. This is so we can learn better ways to treat our~     patients.~   "
215478|NCT00739128|"~     Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and~     carry a high morbidity rate. It has been recently shown that patients with celiac disease~     very often fail to develop immunity after standard vaccination for HBV during infancy. In~     this study, we will evaluate whether a second vaccination series via a different route of~     administration (into the skin rather than the muscle) results in a better immunological~     response in celiac patients. Eligible patients will be randomized to receive a 3-dose~     vaccination series into the skin or to the muscle. Rate of responders and level of immunity~     will be compared. This study will facilitate better protection of celiac patients to this~     potentially deadly virus.~   "
215479|NCT00739115|"~     The purpose of this study is to evaluate the safety and utility of using heliox gas in~     combination with nasal CPAP in premature infants. The investigators hypothesize that using~     heliox gas in combination with nasal CPAP will results in decreased early nasal CPAP failure~     requiring intubation and mechanical ventilation.~   "
215480|NCT00739102|"~     A multi-center, non-randomized, single-arm, prospective trial evaluating the safety and~     effectiveness of the S.M.A.R.T.™ Nitinol Stent System implantation in approximately 250~     patients with obstructive superficial femoral artery disease.~   "
215481|NCT00739089|"~     This is a prospective, observational study to compare presep(tm) catheter central vein mixed~     venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central~     venous dialysis catheter to evaluate device interaction.~   "
215482|NCT00739076|"~     Using Virtual Reality as a form of pain control for trauma patients.~   "
215483|NCT00739063|"~     The goal of this clinical research study is to learn if Tarceva® (erlotinib hydrochloride)~     can help control triple receptor-negative breast cancer. The safety of this drug will also be~     studied.~      Objectives:~      To assess the clinical efficacy, biologic effects and safety of the EGFR inhibitor erlotinib~     in the treatment of patients with 'triple receptor-negative' metastatic carcinoma of the~     breast.~      Primary endpoints:~      1) Time to progression (TTP)~      Secondary endpoints:~        1. clinical benefit rate as defined by complete and partial response and stable disease~        2. overall survival (OS)~        3. safety profile and tolerability of erlotinib~        4. biologic correlative studies~   "
215484|NCT00739050|"~     Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early~     detection of improvement of endothelial function with simvastatin could be a clue for future~     intervention trials.~   "
215485|NCT00739037|"~     The primary purpose of this study is to assess biomarker known as amyloid beta peptide 40~     (Ab40) in Cerebrospinal Fluid (CSF), following a single oral dose of PAZ-417 in subjects with~     Alzheimer Disease (AD). This study will also consider another biomarker amyloid beta peptide~     42 (Ab42) in Cerebrospinal Fluid in subjects with Alzheimer Disease and assess the safety,~     tolerability and pharmacokinetic profile of PAZ-417 in both plasma and Cerebrospinal Fluid in~     these subjects.~   "
215486|NCT00739024|"~     The purpose of this study is to see if ramelteon will reduce the number of migraine headaches~     over a 12 week period. The safety and tolerability of ramelteon will also be evaluated.~     Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia~     (trouble sleeping); however; ramelteon has not been approved for the prevention of migraines.~   "
215487|NCT00739011|"~     This study is designed to determine the effectiveness of two different CPAP devices. One a~     standard CPAP which has the ability to store comprehensive compliance and efficacy data and~     the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to~     automatically adjust CPAP pressure and improve sleep variables.~   "
215488|NCT00738998|"~     The goal of this research study is to learn more about what it is like for patients with~     breast cancer to receive treatment with the drug anastrozole. Researchers want to learn about~     possible symptoms, such as joint pain, that patients may experience during treatment.~     Researchers also want to learn more about which patients are most likely to have joint~     symptoms by looking at certain proteins from routine blood draw samples.~   "
215489|NCT00738985|"~     To measure the percentage of patients who achieve all the treatment lipid goals being treated~     with ezetimibe/simvastatin 10/20 with or without MK0524A (1-2 g/day).~   "
215490|NCT00738972|"~     Evaluate pleiotropic effects of simvastatin in hypertensive patients.~   "
215492|NCT00738946|"~     An investigation will be made of the combined impact of insecticide-treated nets and~     intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria~     morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during~     the malaria season in one year and the follow-up will be extended into the second year by~     passive surveillance.~   "
215493|NCT00738933|"~     This randomized controlled double-blind intervention study unravels influence of dietary~     plant sterols and stanols on the structure and the sterol composition of the human aortic~     valve. The study patients will include 50-60 voluntary patients from the Helsinki Univ.~     Central Hospital, who will undergo aortic valve surgery. The patients will be randomized into~     plant sterol (E), plant stanol (A) and control (C) groups. Patients in the E and A groups~     will be asked to consume daily 2 grams plant sterols or plant stanols, respectively, in a~     margarine product.~   "
215494|NCT00738920|"~     The primary goal of the proposed trial is to assess the short- and long-term efficacy of~     cognitive behavior therapy (CBT) for irritable bowel syndrome using two treatment delivery~     systems (self administered, therapist administered). Secondary aims seek to specify the~     conditions under which CBT may (or may not) achieve its effects (moderator questions), why~     and how these effects are achieved (mediator questions) and at what economic cost. Long term~     project goals are to develop an effective self-administered behavioral treatment program that~     can enhance the quality of patient care, improve clinical outcomes, and decrease the economic~     and personal costs of one of the most prevalent and intractable GI disorders.~   "
215495|NCT00738907|"~     We hypothesize that quantitative measurements of the beta cell mass within the endocrine~     pancreas can be obtained by PET via targeting of vesicular monoamine type 2 transporters with~     the radioligand [11C]DTBZ. and that there will be significant differences in [11C]DTBZ uptake~     in the anatomical space of the pancreas between normal individuals and those with BCM~     predicted to be greater or less than normal based on the measurement of insulin secretion.~   "
215496|NCT00738894|"~     The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE®~     HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder plus antiplatelet medical~     management is safe and effective and reduces the risk of recurrent stroke or~     imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical~     management alone in patients with a PFO and history of cryptogenic stroke or~     imaging-confirmed TIA.~      A co-primary objective is to demonstrate that medical management plus closure with the study~     device reduces the risk of new brain infarct compared to medical management alone~   "
215497|NCT00738881|"~     This randomized phase III trial studies pemetrexed disodium to see how well it works compared~     with erlotinib hydrochloride as second-line therapy in treating patients with non-small cell~     lung cancer that has spread to other places in the body. Pemetrexed disodium and erlotinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. It is not yet known whether pemetrexed disodium is more effective than erlotinib~     hydrochloride in treating advanced non-small cell lung cancer.~   "
215498|NCT00738868|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays~     directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with~     stereotactic radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic~     radiation therapy works in treating patients with recurrent squamous cell carcinoma of the~     head and neck cancer that cannot be removed by surgery.~   "
215499|NCT00738855|"~     Mini abstract :~      Altogether 100 patients with 117 episodes of ASBO were randomized into control and~     gastrografin groups. Eight episodes in eight patients were excluded. Gastrografin group~     showed a significant decrease of both the time between admission and operation and that of~     hospital stay .The need for surgery was reduced but statistically insignificant.~   "
215500|NCT00738842|"~     This study is being conducted to examine the effect of AZD6140 on the levels of certain~     chemicals in subjects' blood and urine.~   "
215501|NCT00738829|"~     The aim of this study is to determine the maximal tolerated dose level of lenalidomide~     combined with fludarabine/rituximab in the therapy of patients with previously untreated~     CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide~     will be given at the pre-determined maximum tolerated dose in combination with rituximab to~     further determine the efficacy and tolerability of this regimen.~   "
215502|NCT00738816|"~     Elderly patients have a higher risk of experiencing adverse drug events due to an age related~     increase in morbidity and medication use. Inappropriate or wrong medication use among elderly~     patients acutely admitted to hospitals is assumed to result in earlier contact to general~     practitioner, emergency departments and re-admissions if not corrected during hospital~     admission. It is therefore our hypothesis that a systematic medication review conducted by~     pharmacists and physicians specialized in pharmacology will increase time to first~     unscheduled physician contact (general practitioner, emergency departments, ambulatory care~     and re-admissions) after discharge from hospital from an average of 21days to 25 days.~     Further, the following secondary outcome parameters will be measured at discharge and within~     3-month follow-up:~        -  length of in-hospital stay~        -  number of contacts to general practitioner 30 days after discharge, that resulted in~          medication changes~        -  number of re-admissions at 3-month~        -  number of death at 3-month~        -  number of contact to primary health care at 3-month~        -  patients self-experienced quality of health(EQ-5D) 3-month~   "
215518|NCT00738608|"~     The aim of this study is to demonstrate that compared to placebo the preoperative~     administration of a single dose of 120 mg etoricoxib can provide adequate pain relief in the~     postoperative phase while reducing the need for systemic opioids. The primary endpoint is the~     decrease of systemic opioid use.~   "
215519|NCT00738595|"~     This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of~     Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated~     to quit smoking. EVT 302 will be compared to placebo both with and without open label~     nicotine replacement therapy.~   "
245158|NCT00344968|"~     This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone~     acetonide for the treatment of diabetic macular edema.~   "
215503|NCT00738803|"~     The investigators aim to demonstrate the ability to accurately measure and restore leg~     length, offset, and center of rotation during a total hip replacement through a new technique~     that uses the femoral component as a measurement tool. The operative technique requires~     inserting the femoral component prior to performing the femoral neck osteotomy. After the~     femoral component is implanted, a reference guide is attached to the femoral component and~     guides a screw into the ilium at a fixed distance from the femoral component. The~     pre-arthroplasty measurements of leg length and offset are recorded. The femoral neck~     osteotomy is performed, and the native femoral head is removed and measured. The acetabular~     socket is prepared and the acetabular component is inserted. A repeat measurement with trial~     modular neck components is taken and allows the surgeon an additional opportunity to~     accurately recreate leg length and offset with the final component. The reference screw is~     removed from the ilium and the incision is closed.~   "
215504|NCT00738790|"~     According to the current opinion, local excision in rectal cancer should be limited to~     selected T1N0 tumours. The investigators addressed the question whether preoperative~     radio(chemo)therapy can expand the use of this procedure for more advanced cancers. The~     rationale of preoperative radiotherapy is eradication of mesorectal subclinical disease.~     Besides, there is a correlation between radiosensitivity of rectal cancers and low cancer~     aggressiveness. For this reason, conversion to abdominal surgery is needed in patients with~     radioresistant tumour. The investigators aim to compare the short-course radiotherapy~     schedule with the chemoradiation in order to determine an optimal scheme. The study~     hypothesis is that the chemoradiation assures 25% more patients who do not require conversion~     to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative~     radiotherapy and local excision for radiosensitive rectal cancer.~   "
215505|NCT00738777|"~     To investigate prospectively whether short term endocrine treatment can induce molecular~     changes, predictive for therapy response.~   "
215506|NCT00738764|"~     This is a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with~     advanced solid tumors.~   "
215507|NCT00738751|"~     The main purpose of the study is to:~        -  Determine the safety and tolerability of erlotinib and LBH589B.~        -  Establish a recommended phase II expansion dosing of LBH589B and erlotinib in patients~          with advanced aerodigestive tract cancers.~   "
215508|NCT00738738|"~     This is an open-label, multi-site, 6-month study of an investigational compound in elderly~     outpatients, age 65 years old or above, to assess the long-term safety and tolerability of~     the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).~   "
215509|NCT00738725|"~     The BioImage Study is a study of the characteristics of subclinical cardiovascular disease,~     as measured by imaging modalities, unsupervised circulating biomarker measurements, and risk~     factors that predict progression to overt clinical cardiovascular disease, in a diverse,~     population-based sample of 7,300 men (aged 55-80) and women (aged 60-80). The~     socio-demographics of the study population aims to mirror the US population as a whole with~     approximately 69% of the cohort will be white, 12% African-American, 13% Hispanic, 4% Asian,~     predominantly of Chinese descent and 2% other (U.S. Census Bureau: 2000).~      The cohort will be recruited from the Humana Health Plan membership represented in three~     major US markets; Chicago, Illinois, Louisville, Kentucky and Southern Florida. Of the 7,300~     participants, 6,000 will be characterized with respect to their Framingham risk score and~     various imaging features including coronary calcification, carotid intima-media thickness~     (IMT), presence of atherosclerotic plaques, and lower extremity vascular insufficiency as~     determined by the ankle brachial index (ABI). Blood samples will be assayed for putative~     biomarkers using a variety of methodologies including unsupervised proteomic and metabolomic~     profiling of plasma, RNA expression profiling and candidate gene analysis or genome wide~     scanning. These approaches will also be combined with targeted assays for particular~     analytes. Biological samples will be banked at the time of collection for these analyses and~     for additional follow on case-control and validation studies. Participants will be followed~     for identification and characterization of cardiovascular disease events, including acute~     myocardial infarction and other forms of Coronary Artery Disease (CAD), and stroke;~     mortality; and for cardiovascular disease interventions. The remaining 1,300 subjects will be~     evaluated and followed in a similar manner except no imaging studies will be conducted.~      The study will be conducted using an innovative infrastructure and method of participant~     recruitment and enrollment. Mobile clinics containing the imaging equipment will travel to~     the three markets included in the study. The mobile clinic configuration allows for a high~     level of consistency in the data measurements which will be collected from diverse geographic~     areas and populations. Participants will be recruited based on claims monitoring to~     pre-determine eligibility. The baseline examinations of the 7,300 participants will occur~     over a 12-month period. Based on particular findings (Coronary Artery Calcium (CAC) score,~     Carotid Intima-Media Thickness (IMT), atherosclerotic plaque, Ankle Brachial Index (ABI), and~     presence of Abdominal Aortic Aneurysm (AAA), approximately 3,000 participants of the 6,000~     imaging cohort will be referred for higher resolution imaging modalities to better~     characterize their arterial disease. This additional imaging will also be conducted at the~     mobile clinics and occur during the same 12-month period. Participants will be contacted~     every 6-months throughout the 3-year study to assess cardiovascular events, clinical~     morbidity and mortality, and to obtain additional blood samples.~   "
215510|NCT00738712|"~     This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies designed~     to improve MRI examinations of the vascular structures, abdomen, and pelvis regions.~   "
215511|NCT00738699|"~     The study is being conducted to find out if paclitaxel works better when given together with~     an experimental drug called MORAb-003 (farletuzumab) or alone in patients with~     platinum-resistant or refractory relapsed ovarian cancer~   "
215512|NCT00738686|"~     The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel~     disease and multiple Taxus stent implantations in the real world stenting at 30 days, 6 and~     12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to~     economic considerations, the secondary aim is to enhance experience in multivessel stenting~     with drug-eluting stents in order to improve short- and long-term outcomes of the patients~     with severe multiple coronary artery stenoses.~      The objectives of the study are:~        1. To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical~          follow-up after multivessel intervention with drug-eluting stents in a prospective~          patient cohort..~        2. To determine the rate of in-stent restenosis, target lesion and target vessel~          revascularization (angiographic measures) 6 months in patients with multiple DESs in~          multiple lesions.~        3. To investigate the clinical and angiographic outcomes after implantation of multiple~          DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal~          insufficiency) with known high restenosis and late complication rate.~        4. To evaluate potential cost burden in attempting a strategy of complete revascularization~          by multiple DES in patients with multivessel disease.~   "
215513|NCT00738673|"~     This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12~     months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal~     treatment in Prostate Cancer patients who experienced PSA-Failure following~     gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in~     Testosterone levels at inclusion.~   "
215514|NCT00738660|"~     Hypothesis:~      The angiotensin receptor blocker telmisartan is effective at reduction of albumin excretion~     rate(AER) in patients with type1 diabetes and micro or macroalbuminuria. Dual blockade with~     the addition of ramipril an angiotensin receptor blocker gives added efficacy for reduction~     of AER. ARB telmisartan gives a 24 hr BP lowering effect.~      Summary:~      This is an open label cross over study involving 30 patients who were initially treated with~     Telmisartan 80 mg for eight weeks followed by addition of Ramipril 10 mg for a further eight~     weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were~     studied at the end of each phase.~   "
215515|NCT00738647|"~     Evaluation of a new resin-based composite material.~      Amalgam and composite are the most commonly used restorative materials in dentistry. Due to~     the toxicity of mercury and the subsequent environmental problems, the search for~     alternatives continues and search into new composite restorative materials intensifies. The~     presently available composites have improved, but shrinkage of the composite during the~     curing procedure is still a clinical problem. A new composite restorative material has among~     other advantages demonstrated lower shrinkage in laboratory studies, due to a new formulation~     of the material.~      This project aims to study the clinical performance of this new composite compared to a~     commonly used composite restoration material. 72 patients (158 teeth) are allocated to the~     project which is carried out at the School of dentistry, University of Aarhus, Denmark.~   "
215516|NCT00738634|"~     The purpose of this study is to determine whether physical activity prevents development of~     depressive symptoms in adolescents.~   "
215520|NCT00738582|"~     This research is being done to find out if pemetrexed and cisplatin work better when given~     together with an experimental drug called MORAb-009 in patients with malignant pleural~     mesothelioma.~   "
215522|NCT00738556|"~     Most doctors who use the new drug-eluting stents for the treatment of long coronary~     narrowings tend to cover the full length of the lesion with long or multiple stents. The~     investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very~     tight parts of the coronary narrowing, might result in better outcomes by means of avoiding~     multiple stents that have been associated with significant complications such as late stent~     thrombosis.~   "
215523|NCT00738543|"~     The investigators have few options for skin antisepsis. Alternatives for povidone-iodine,~     which is the most commonly used agent, are costly or ineffective. To have more options, this~     study is needed. The investigators want to know if there are difference between the use of~     10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.~   "
215524|NCT00738530|"~     This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in~     combination with Roferon as first-line treatment in participants with metastatic renal cell~     cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is~     1-2 years, and the target sample size is greater than (>)500 individuals.~   "
215525|NCT00738517|"~     The purpose of this study is to investigate, if immunoadsorption of autoantibodies with~     subsequent substitution of immunoglobulins is able to improve cardiac function of patients~     with heart failure after myocardial infarction and presence of cardiac autoantibodies.~   "
215526|NCT00738504|"~     The purpose of this study is to determine if intensive insulin therapy really reduces the~     incidence of acute kidney injury in critically ill patients, using for analysis the RIFLE~     criteria for definition of AKI.~   "
215527|NCT00738491|"~     The purpose of this study is to identify whether exposure to ambient levels of air pollution~     during normal daily activities has a functional impact on patients with coronary heart~     disease~   "
215528|NCT00738478|"~     The aim of the study is to evaluate whether distal gastrectomy without post-operative~     nasogastric decompression tube is better in terms of quality of life.~   "
215529|NCT00738452|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as carboplatin, paclitaxel, cisplatin, and etoposide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing~     substances to them without harming normal cells. Giving radiation therapy and combination~     chemotherapy together before radiolabeled monoclonal antibody therapy may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of radiolabeled~     monoclonal antibody therapy when given after radiation therapy and combination chemotherapy~     in treating patients with stages I-IIIB non-small cell lung cancer.~   "
215530|NCT00738439|"~     The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative~     adult spinal deformity patients.~   "
215531|NCT00738426|"~     The purpose of this study is to determine whether green diode low level laser therapy is~     effective for body contouring of the waist, hips and thighs.~   "
215532|NCT00738413|"~     Subjects with thalassemia major require regular transfusion therapy to sustain life. The iron~     present in the transfused blood remains in the body where it can cause a variety of organ~     dysfunctions. Lifelong iron chelation therapy is needed to maintain iron balance but its~     effectiveness varies greatly. Like that of deferoxamine (Desferal, DFO) the mainstay of~     chelation therapy for 30 years, the effectiveness of deferasirox (Exjade, ICL670), the newly~     approved, orally effective iron chelating drug, is not satisfactory in all subjects. Even~     with good compliance, the iron excretion induced by a given drug exhibits wide~     subject-to-subject variability. There is often persistent iron overload of extra hepatic~     tissues such as the heart and pancreas leading to cardiac disease and diabetes. Combining the~     drugs may be a better approach in those subjects at increased risk. The iron balance studies~     proposed will permit an assessment of the potential of such a combination to place subjects~     in net negative iron balance and the relative effectiveness of the combination in relation to~     that of the individual drugs, an additive effect being expected. With such information,~     physicians will be able to design individualized chelation regimens that maximize~     effectiveness while minimizing side effects by adjusting the ratio and/or the dosing schedule~     of the two drugs.~   "
215533|NCT00738400|"~     This is a controlled, randomized, multi-center prospective study of vardenafil to determine~     efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic~     Syndrome. This study will explore the rate of patients who do need to switch to the highest~     dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re~     nata)~   "
215534|NCT00738387|"~     The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes~     the cancer treatment more effective in patients with locally advanced or metastatic non-small~     cell lung cancer~   "
215535|NCT00738374|"~     This single arm study will assess the efficacy and safety of MabThera + chlorambucil as~     induction therapy, followed in responders by maintenance therapy or observation in elderly~     patients with previously untreated chronic lymphocytic leukemia. During the induction phase~     patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses~     of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses~     of MabThera given every 8 weeks, or no further treatment. The anticipated time on study~     treatment is 2+ years, and the target sample size is <100 individuals.~   "
215536|NCT00738361|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle~     formulation works in treating patients with metastatic melanoma of the eye that cannot be~     removed by surgery.~   "
215537|NCT00738348|"~     It is reported that sivelstat improved and preserved the postoperative renal function in the~     orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it~     improved acute lung injury. During liver resection, Pringle maneuver, clamping the~     hepatoduodenal ligament, was performed. Pringle maneuver causes reperfusion injury of the~     liver. We have a hypothesis that sivelstat prevent the warm shock of reperfusion injury of~     the liver by Pringle maneuver.~   "
248994|NCT00293527|"~     This study will determine the response rate of daily low dose interferon-alpha-2b in patients~     with metastatic or unresectable clear cell renal cell carcinoma.~   "
215538|NCT00738335|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic~     radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to~     normal tissue. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving~     erlotinib together with stereotactic radiosurgery may kill more tumor cells.~      PURPOSE: This phase I clinical trial is studying the side effects of erlotinib when given~     together with stereotactic radiosurgery and to see how well it works in treating patients~     with non-small cell lung cancer with brain metastases.~   "
215539|NCT00738322|"~     The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the~     medication is metabolised by the body ( how it is taken up into the body, distributed around~     the body and disappears from the body) in healthy Japanese males.~   "
215540|NCT00738309|"~     The purpose of this study to determine the radiographic and clinical outcomes of spinal~     deformity surgical treatment in patients with Scheuermann's Kyphosis.~   "
215541|NCT00738296|"~     Comparison of the effect on the progression of the carotid intima-media interphase thickness~     (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct~     measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients~     with established cardiovascular disease (myocardial infarct, atherosclerotic coronary~     disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density~     lipoprotein level > 100 mg/dL, treated with simvastatin, pravastatin or the combination of~     simvastatin-ezetimibe during a period of at least one year.~   "
215542|NCT00738283|"~     We propose to examine the absorption and excretion of zinc and copper in infants with~     ostomies. This will be accomplished by measuring baseline excretion and serum levels of zinc,~     copper, and ceruloplasmin, and by utilizing stable isotopes of zinc and copper to measure~     absorption and excretion.~      To determine how the presence of an ileostomy impacts zinc and copper metabolism in infants~     at three time points: 1) when the infant has an ostomy and is receiving the majority of~     calories from total parenteral nutrition (TPN); 2) when the infant has an ostomy and is~     receiving primarily enteral nutrition without TPN; and 3) when/if the infant has a surgery to~     reconnect the bowel and is receiving primarily enteral nutrition.~      For the first part of the study, excretion data for zinc will be obtained for ostomy~     patients. We hypothesize that infants with an ostomy will excrete more zinc in their stools~     than healthy term or preterm infants without ostomies.~      For the second part of the study, we will obtain data on zinc absorption, secretion, and~     excretion through use of stable isotopes. Jalla et al determined that healthy infants retain~     zinc of 0.4 mg/day. We hypothesize that due to increased zinc losses, the infants in the~     study will be less positive than the healthy infants in the study by Jalla et al. Our study~     is designed to be able to detect if the ostomy patients net retention is one-half that~     described by Jalla (i.e. 0.2 mg/d). We will also obtain data on copper absorption, secretion,~     and excretion through the use of stable isotopes in the second part of the study. As a pilot~     study, we do not fully know what to expect regarding copper levels in infants with ostomies,~     but we hypothesize that they may be less positive than healthy infants without ostomies.~     Also, we hypothesize that zinc and copper are competitively absorbed in the gut; therefore,~     infants who receive more zinc may absorb less copper.~      For the third part of the study, we will obtain data on zinc absorption through the use of~     stable isotopes after the infant has had surgery to reanastomose the bowel. We hypothesize~     that there may be continued zinc losses above those documented for healthy infants who have~     never had an ostomy, but decreased losses compared to when the infant had an ostomy.~   "
215543|NCT00738257|"~     The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density~     loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A~     and glucocorticoid based immunosuppressive regimen.~   "
215544|NCT00738244|"~     Wind-noise is highly disturbing to hearing impaired individuals wearing hearing aids who wish~     to participate in outdoor conversations where wind is present or during activities such as~     walking or running. In these situations, wind noise significantly reduces signal-to-noise~     ratio and, consequently, the intelligibility of speech and sounds may be significantly~     impaired. This negative effect is exacerbated with the use of directional microphone schemes~     in the hearing iads. The objective of this project is to determine the efficacy of the MH~     Acoustics' multi-microphone wind-noise reduction invention for the digital hearing aids~     market. MH Acoustics' wind noise reduction technology is unique since it provides~     instantaneous convergence while maintaining directionality of the microphone array. Current~     commercial technologies do not provide this feature. We are hypothesizing that, due to the~     design of the algorithm, speech perception ability and sound quality perception will be~     better than that available with traditional directional and/or omnidirectional microphone~     schemes in windy environments.~   "
215545|NCT00738231|"~     This study is an interventional study which was conducted in the field. The investigators~     intended to develop an efficient and economically valuable method which can decrease the risk~     factors for prevention of cardiovascular diseases. Effective control of cardiovascular~     diseases necessitates a salutogenetic approach to develop efficient and cheap methods to~     decrease risk factors.~      In this study, the aim of preparing the Group II training material was to enable the~     individual to see his or her risks as unique, and to proceed with life by adapting personal~     behaviors. Group II's training material was formatted as a prescription. Because giving a~     prescription for a doctor is very important in low socioeconomical group person.~      This study showed that social programs oriented towards individual behavioral changes assume~     an important role in decreasing cardiovascular risk factors.~   "
215546|NCT00738218|"~     To compare the diagnostic ability of 64-detector MDCT coronary angiography with conventional~     invasive coronary angiography in patients with suspected coronary artery disease.~   "
215547|NCT00738205|"~     This is an international, multicenter study involving children treated with Saizen®, a growth~     hormone, who will be trained to use easypod, a new electronic injector and will complete a~     questionnaire after 12 week of use.~      Both children naïve to growth hormone and dissatisfied with their current injection device~     will be recruited.~   "
215548|NCT00738192|"~     Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated~     anesthetic induction and maintenance, whereas corresponding pain during awakening influences~     patient's rehabilitation strongly. In addition, such early postoperative pain results in~     significant stress responses, which displays as further release of stress hormones such as~     cortisol and β-endorphin as well. How to prevent such acute pain resulting from~     remifentanil's fast metabolism endows clinical significance. This study is designed to~     compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after~     gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance,~     and investigate corresponding influence on the levels of blood cortisol and β-endorphin.~   "
215650|NCT00736866|"~     The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo~     for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures~     that use contrast.~      Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the~     procedure.~   "
220177|NCT00676910|"~     The purpose of this study is to assess the safety of JNJ-26854165 (a new drug in development~     for cancer) in patients with advanced or refractory solid tumors on the maximum dose~     tolerated by these patients.~   "
215549|NCT00738179|"~     Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several~     seconds at a time due to relaxation of the throat muscles. This can occur many times during~     sleep. It is known to cause sleepiness and poor concentration during the day. Research~     indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its~     association with hypertension, stroke, heart attack and sudden death. The standard therapy~     for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to~     effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly~     reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of~     SAVE is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for~     people with OSA.~   "
215550|NCT00738166|"~     Trace elements, bioactive secondary metabolites and vitamins are among the most important~     quality parameters in plants. Yet, very little information is available on their content,~     bioavailability and health effects of organically grown plant food products. The main~     objective of the project is to study the impact of different agricultural management~     practises relevant for organic farming on the ability of cereal and vegetable crops to absorb~     trace elements from the soil and to synthesise bioactive compounds (secondary metabolites,~     antioxidant vitamins and phytates) with health promoting effects. Field experiments with a~     rigidly controlled design will be implemented together with state-of-the-art analytical~     techniques allowing solid conclusions to be drawn on the variability and optimum levels of~     bioactive compounds. The multitude of analytical data from plant and soil samples will be~     analysed by multivariate statistical methods in order to reveal differences between the~     cultivation systems used. Finally, the relationship between bioavailability of the nutrients~     studied and the elemental fingerprint of plants will be extracted by the statistical methods.~   "
215551|NCT00738153|"~     This observational study is conducted in Africa. The aim of this observational study is to~     evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin~     Levemir® under normal clinical practice conditions.~   "
215552|NCT00738140|"~     The purpose of this study is to discover if intensive lifestyle changes (such as diet and~     increased physical activity) improve the body's sensitivity to insulin, and therefore help~     prevent diabetes and other cardiovascular disease, in men receiving GnRH hormone therapy for~     prostate cancer.~   "
215553|NCT00738127|"~     The purpose of this study is to determine a surgical technique is effective in the treatment~     of acute dorsal trans-scaphoid perilunate dislocations.~   "
215554|NCT00738114|"~     High blood glucose levels in surgical patients with and without diabetes are associated with~     increased risk of medical complications and death. Over the short-term, high blood glucose~     can adversely affect fluid balance, impair immunologic response to infection, and promote~     inflammation and endothelial dysfunction (blood vessel function). Blood glucose control with~     intensive insulin therapy in patients with critical illness (very sick patients in intensive~     care unit) reduces the risk of multiorgan failure and systemic infections, and decreases~     short- and long-term mortality. High blood glucose has also been associated with poor outcome~     in non-critically ill patients admitted to general surgical and medical wards; however,~     intensive glycemic control is not aggressively pursued because of fear of hypoglycemia. A~     computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966~     to 2008 provided very little information on the prevalence and outcome of high blood glucose~     during the perioperative period (before and after surgery) in non-critically ill patients.~     Therefore, the present study aims to evaluate the impact of high blood glucose, in large~     number of subjects with and without diabetes, during general (non-cardiac) surgery.~   "
215555|NCT00738101|"~     To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated~     cholestasis to receive Omegaven for compassionate use situations for which there are no~     satisfactory alternative treatments.~   "
215556|NCT00738088|"~     The study hypothesis is that people who respond well to sulphonylureas have a different~     underlying cause for their diabetes than people who respond poorly to this medication. We are~     using two approaches to study this. In one approach we look at people who have previously~     responded well or poorly, confirm this by rechallenging them with a sulphonylurea drug, and~     then looking at how well they produce insulin in response to glucose and an intravenous~     sulphonylurea called tolbutamide. The second approach identifies people with a certain~     genetic predisposition to diabetes (due to changes in the TCF7L2 gene) and then looks at how~     well they respond to sulphonylurea medication.~   "
215557|NCT00738075|"~     The investigators hypothesize that mathematical algorithm can identify freezing episodes~     based on data obtained from accelerometer.~   "
215558|NCT00738062|"~     The purpose of this study is to assess the durability of effect of Droxidopa in treating~     symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure~     (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic~     neuropathy, or Beta Hydroxylase deficiency.~   "
215559|NCT00738049|"~     The primary objective of this study is to test the hypothesis that myocardial perfusion~     heterogeneity, quantified by Markovian Homogeneity analysis of cardiac PET perfusion images,~     will improve in a quantitative manner after treatment with selective ETA receptor antagonist~     darusentan 100 mg per day for 2 weeks compared to baseline and post-treatment PET scans in~     clinically stable subjects with coronary atherosclerosis and/or risk factors.~   "
215560|NCT00738036|"~     To define a rational pharmacological management of pain for the subjects under opioid~     maintenance therapy (methadone or buprenorphine), it is first of all necessary to estimate~     the efficiency of the current practices on pain management as well as their potentially~     noxious consequences, in particular on the long term opioid maintenance therapy.~      The objective of the study is to compare the efficiency of the opioid maintenance therapy~     according to the arisen of an acute painful phenomenon requiring an analgesic management for~     these patients. At first, this work will allow to determine the results on acute pain of the~     current practices for these patients. The comparison of the long term consequences on opioid~     maintenance therapy between the patients that presented an acute painful phenomenon and the~     control patients should help to improve acute pain management for these patients while~     limiting the risk of relapse in the abused consumption of psychoactive substances.~   "
215691|NCT00736320|"~     This study is designed to test the non-inferiority of the experimental arm compared to the~     standard arm in terms of Progression free survival (PFS).~   "
215561|NCT00738023|"~     Insulin resistance has been implicated as the central pathogenetic feature of cardiovascular~     risk factor cluster that includes hypertension, impaired glucose tolerance, diabetes,~     dyslipidemia, and hemostatic disorders. Recent evidence suggests that increased levels of~     free fatty acids (FFA) in obese subjects is a leading candidate in the pathogenesis of~     insulin resistance (1-4). In our preliminary studies on the effect of FFA on insulin~     secretion and action (lipotoxicity), we have observed that the infusion of Intralipid/heparin~     to increase FFA ~ four-fold-baseline levels for 48 hours results in a significant and~     reproducible raise in systolic and diastolic blood pressure (BP) in obese African American~     subjects with and without diabetes. The increase in blood pressure is apparent after 12 hours~     of infusion, reaching a peak increment of 32 mm Hg in systolic and 14 mm Hg in diastolic~     pressure at 24 hours. These preliminary findings indicate that, in addition to the well-known~     effect on insulin resistance, sustained elevation of FFA results in the development of an~     acute metabolic syndrome.~   "
215562|NCT00738010|"~     Prospective, controlled, randomized, single blind study in patients undergoing rehabilitation~     following anterior cruciate ligament reconstruction. 96 patients were randomly assigned to~     one of three groups. Group Group KH (Kneehab n=33)trained with a new type of NMES with~     multipath activation for 20 minutes, 3 times per day, 5 days per week for 12 weeks; Group PS~     (Poli-Stim n=29) trained with standard neuromuscular electrical stimulation (NMES) for 20~     minutes per day, 5 days per week for 12 weeks; Group CO (Control - n=34), which did not use~     muscle stimulation, performed voluntary isometric quadriceps muscle contractions. Patients~     receiving either form of NMES treatment were instructed to isometrically contract the~     quadriceps muscle voluntarily with each electrical muscle stimulation. All three groups~     superimposed this training schedule on the standard post-ACL reconstruction rehabilitation~     protocol used at the clinic.~      The study design corresponded to a two-way variance analysis with three groups and 4~     examination times (Baseline, 6 weeks, 12 weeks and 24 weeks post ACL reconstruction). The~     level of significance was set at 5%. The key indicators of the quadriceps muscle training~     intervention were the isokinetic strength development of the extensors of the injured leg at~     90 degrees/second and 180 degrees/second and the distance achieved by participants performing~     the single-leg hop and the time to complete the shuttle run. The target was to show a~     difference of 10% in the relative distance jumped for the single-leg hop and for the~     isokinetic strength tests and a 1.2 second difference in the time to complete the shuttle~     run. The target of 3 weeks was set for participants to achieve full weight-bearing capability~     without use of a walking aid. A comparison between the groups of the time for return to usual~     work activities was planned.~   "
215563|NCT00737997|"~     The purpose of this study is to examine if morphine administered by bolus before initiating~     Remifentanil by infusion decreases the incidence of acute post-operative opioid tolerance as~     demonstrated by decreased post - operative morphine consumption in children undergoing~     scoliosis surgery.~   "
215564|NCT00737984|"~     Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles~   "
215565|NCT00737971|"~     Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema~   "
215566|NCT00737958|"~     The purpose of this study is to determine whether exposure to diesel exhaust (air pollution)~     has a functional impact on patients with stable angina pectoris.~   "
215567|NCT00737945|"~     The investigators test the additional clinical value of the physiological assessment of~     endothelial function to the morphological assessment of coronary complexity and classical~     risk score in predicting cardiovascular events.~   "
215568|NCT00737932|"~     The study aims to evaluate the safety and clinical effect of daily oral treatment of~     Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess~     Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is~     a novel immunomodulating drug which is currently in advanced stages of development by Teva~     Pharmaceuticals Ltd. for Multiple Sclerosis.~   "
215569|NCT00737919|"~     This study aims to explore whether the increased supply of dietary plant sterols and plant~     stanols have any influence on serum levels of phytosterols and on consistency of carotid~     atheromatous plaques.~   "
215570|NCT00737906|"~     The primary goal of this post-marketing surveillance study is to assess whether surgical~     turbinate reduction performed using a Coblation® device is associated with reduced nasal~     obstruction symptoms.~   "
215571|NCT00737893|"~     This research study aims to explore the effectiveness of human erythropoietin versus placebo~     in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing~     radical retropubic prostatectomy for clinically localized prostate cancer.~      Pre-clinical studies have shown erythropoietin potently promoted recovery of erectile~     function in rats and humans have similar receptors on penile tissues and the periprostatic~     neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical~     prostatectomy demonstrated a benefit to recovery of erectile function.~      Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing~     nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction~     and also an improved rate of erection recovery following surgery.~   "
215572|NCT00737880|"~     Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by~     topic cooling and cold in situ flushing using special perfusion solutions designed to~     attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance.~      For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly used~     perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK) solution~     has been increasingly used for abdominal organ procurement. Retrospective reports published~     so far have demonstrated the safety of both perfusion solutions.~      However, to date, no prospective study comparing both perfusion solutions has been published.~     Aim of this study was to prospectively evaluate early pancreas graft function in clinical~     pancreas transplantation after organ perfusion with HTK vs. UW solution.~      The study hypothesis is that HTK is not inferior to UW for organ perfusion during procurement~     in clinical pancreas transplantation.~   "
215573|NCT00737867|"~     The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is~     better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung~     cancer, in terms of survival, quality of life and need for palliative radiotherapy.~   "
215648|NCT00736892|"~     Acute lung injury is a clinical syndrome of rapid onset of acute respiratory failure. It~     represents a significant public health issue. Patients with acute lung injury require~     admission into critical care units for advanced life support and utilize considerable health~     care resources. Published epidemiological studies on acute lung injury in the last 20 years~     are difficult to compare because they used different definitions and length of time for~     evaluation. Less than five studies have collected information for an entire year, and none of~     them have evaluated the degree of oxygenation failure under standard settings. We will~     perform a one-year prospective audit of all patients admitted with acute lung injury in~     almost 40 ICUs in Spain.~   "
215574|NCT00737854|"~     Oral lichen planus is a common chronic mucocutaneous disease with various clinical forms.~     Erosive-ulcerative forms usually cause symptoms of pain and discomfort. The most important~     complication of OLP is development of oral squamous cell carcinoma, although this is a very~     controversial matter. various treatments have been suggested for OLP but their results are~     unsatisfactory. Through the experiences of the investigators, corticosteroids (in any form)is~     not a wise option for treating OLP and has many side effects . More over, immunosuppressive~     therapy did not influence the risk for oral cancer. The purpose of the study is to determine~     the efficacy of free soft tissue graft in the treatment of precancerous and symptomatic~     lesions of OLP. Removal of the lesions up to submucosa has been done. The graft sliced from~     healthy mucosa also up to submucosa. Then graft will be sutured in position.~      According to other authors, basal epithelial layers of the graft remain intact and represent~     the focus of re-epithelization. New epithelial cells migrate over the basal membrane and~     appear to guide it by proliferation, will generate new epithelium. The wound is~     re-epithelialized by proliferation of surrounding healthy epithelial cell, therefore, not~     contaminated by modified antigens of the cell membrane that are theoretically responsible for~     lymphocyte aggression. The healthy graft remains free of lesions and appears clinically~     healthy.~   "
215575|NCT00737841|"~     There has been no data on effect of Bifidobacterium breve on symptoms of patients with~     irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on~     symptoms of IBS patients.~   "
215576|NCT00737828|"~     The investigators would like to evaluate the use of cardiopulmonary exercise tests (CPX) in~     guiding the care pathway of patients undergoing colorectal operations. In the intervention~     group care will be guided by CPX results and in the control group care will be guided by the~     doctors assessment. The investigators would like to assess the impact of this on patient~     outcome, patient satisfaction and resource usage.~   "
215577|NCT00737815|"~     The investigators recent epidemiologic work in several national surveys and cohorts of men~     and women have shown that dietary patterns high in plant-based foods and phytochemicals are~     associated with lower plasma levels of insulin, triglycerides, and C-reactive protein, and~     reduced risk of type 2 DM and CHD. While the physiologic impact of different foods on serum~     glucose and insulin is of critical importance, the extent to which specific dietary nutrients~     can modify insulin resistance is not well understood. Magnesium is a biologically active~     constituent in whole-grain, green leafy vegetables, and nuts and appears to play an essential~     role in hundreds of physiologic processes in humans. However, it remains uncertain whether~     magnesium intake can exert effects on insulin sensitivity and inflammation. Moreover, little~     is known of the extent to which magnesium intake elicits changes in the expression levels of~     key genes responsible for glucose homeostasis and systemic inflammation. The ultimate~     clinical question is whether magnesium supplementation would be clinically effective for the~     improvement of metabolic disorders in not yet diabetic but high-risk individuals, especially~     those who are susceptible to insulin resistance. Therefore, as a direct follow up on our~     previous work in studying the health benefits of plant-based foods such as whole grains,~     fruits and vegetables, we propose a pilot randomized trial to unravel the metabolic and~     anti-inflammatory effects of magnesium supplementation versus placebo among overweight~     individuals with the metabolic syndrome who are particularly prone to the adverse effects of~     magnesium deficiency. Recent advancements in molecular genetics and genomic technologies have~     also enabled us to analyze the expression levels of thousands of genes simultaneously in~     different experimental conditions. The application of high throughput microarray technology~     in randomized-controlled setting when analyzed with novel statistical methods, will not only~     help our understanding of nutrient-disease relations, but also afford the investigators the~     opportunity to gain important insight into the molecular mechanism for complex biological~     systems of inflammation, insulin resistance, and metabolic abnormalities in response to~     nutrition intervention.~   "
215578|NCT00737802|"~     The purpose of this study is:~        -  To study the components of the gastroesophageal junction high-pressure zone individually~          and as a group, by pharmacologically eliminating or accentuating the pressure profile~          generated by the smooth muscle components.~        -  To differentiate the gastric sling fibers from the clasp fibers based on the spatial~          orientation of these muscle groups.~   "
215579|NCT00737789|"~     The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily~     (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses~     (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks,~     in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI)~     score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema~     containing 1g of mesalazine at bedtime during the initial 4 weeks.~      Participants in remission at week 8 received an additional 4 weeks of maintenance therapy~     with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8~     completed the study at week 8.~   "
215580|NCT00737776|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical~     practice conditions in Korea. A clinical safety profile will be also evaluated.~   "
215581|NCT00737763|"~     In this single-center therapeutic study, we will study the ability of efalizumab to protect~     remaining beta cells in teenagers and young adults who have been newly diagnosed with type 1~     diabetes mellitus. Efalizumab is a monoclonal antibody which prevents the activation of~     antigen specific T lymphocytes to sites of inflammation. Efalizumab was approved by the FDA~     in 2003 for the treatment of psoriasis. It has been proven to be safe, well tolerated and~     effective in targeting T cell mediated disorders like those seen in autoimmunity.~   "
215589|NCT00737659|"~     In order to avoid renal transplant rejection, the immune system should be suppressed. After~     the renal transplant subjects are treated with a combination of two to four different types~     of immunosuppressive drugs. Theses drugs are very efficient in the prevention of the renal~     transplant rejection. Still, they can cause side effect.~      Research in renal transplant tries to find the best treatment in order to avoid renal~     rejection on one hand and to reduce as much as possible the undesired adverse and toxicity~     effects on the other hand.~      Therapeutic efficacy and the onset of adverse effects are influenced by levels of~     mycophenolic acid (MPA, the active metabolite of MMF, CellCept®).~      The primary objective of this study is to assess the treatment superiority of CellCept® Dose~     Adjustment treatment, based on individual MPA concentration value monitored periodically,~     against treatment with CellCept® Fixed Dose (standard care).~   "
215649|NCT00736879|"~     The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can~     help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well~     controlled on diet and exercise alone. The safety of this treatment will also be studied~   "
215692|NCT00736307|"~     The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex~     vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface~     reconstruction in cases of partial and sever limbal stem cell deficiency.~   "
215582|NCT00737750|"~     Prospective, controlled, randomized, single blind study in patients undergoing rehabilitation~     following anterior cruciate ligament reconstruction. 96 patients were randomly assigned to~     one of three groups. Group Group KH (Kneehab n=33)trained with a new type of garment~     integrated NMES for 20 minutes, 3 times per day, 5 days per week for 12 weeks; Group PS~     (Poli-Stim n=29) trained with standard neuromuscular electrical stimulation (NMES) for 20~     minutes per day, 5 days per week for 12 weeks; Group CO (Control - n=34), which did not use~     muscle stimulation, performed voluntary isometric quadriceps muscle contractions. Patients~     receiving either form of NMES treatment were instructed to isometrically contract the~     quadriceps muscle voluntarily with each electrical muscle stimulation. All three groups~     superimposed this training schedule on the standard post-ACL reconstruction rehabilitation~     protocol used at the clinic.~      The study design corresponded to a two-way variance analysis with three groups and 4~     examination times (Baseline, 6 weeks, 12 weeks and 24 weeks post ACL reconstruction). The~     level of significance was set at 5%. The key indicators of the quadriceps muscle training~     intervention were the isokinetic strength development of the extensors of the injured leg at~     90 degrees/second and 180 degrees/second and the distance achieved by participants performing~     the single-leg hop, the shuttle run. The target was to show a difference of 10% in the~     relative distance jumped for the single-leg hop and for the isokinetic strength tests and a~     1.2 second difference in the time to complete the shuttle run. The target of 3 weeks was set~     for participants to achieve full weight-bearing capability with use of a walking aid. A~     comparison between the groups of the time for return to usual work activities was planned.~   "
215583|NCT00737737|"~     This study will examine hormone function in men with osteoarthritis pain and how it is~     affected by opioid medication (such as Percocet, Vicodin, MS Contin and morphine) versus~     placebo.~      Men between 30 and 65 years of age who have had moderate to severe osteoarthritis joint pain~     at least 5 days a week over the past 3 months may be eligible for this study. Candidates are~     screened with a physical examination, x-rays, laboratory and other tests, and questionnaires~     about pain, mood and medical health. They are given a pain diary to complete for 2 weeks.~      Participants are admitted to the hospital for two 12 hour overnight stays, during each of~     which they provide a 24-hour urine collection and have a small blood sample drawn every 20~     minutes for 12 hours (from 8:00 p.m. to 8:00 a.m.) through a catheter that remains in place~     in a vein. Blood pressure and pulse are monitored during this time. After the catheter is~     removed, subjects complete questionnaires about their pain, mood and activity.~      For the several weeks between the two hospitalizations, subjects take either an opioid~     medication or placebo, or standard medication such as motrin and naprosyn, according to~     random assignment to one of the three groups. All participants will be allowed to take~     anti-inflammatory medications and acetaminophen during this time as needed, but no other pain~     medications or treatments. They are monitored two or three times a week by telephone and~     complete a pain diary.~      After the second hospitalization, subjects are tapered off the study medication. After 2 to 4~     weeks of stopping medication, they return for a final outpatient visit to review pain or~     other medical problems and to have blood drawn.~   "
215584|NCT00737724|"~     The purpose of this study is to evaluate and compare the efficacy of immediate antiretroviral~     therapy versus 2 month deferred anti-Tb therapy upon the clinical course of tuberculosis and~     HIV infection in patients with AIDS and active tuberculosis.~   "
215585|NCT00737711|"~     This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and~     tolerability of two-weekly intravenous administration of Mircera in dialysis patients with~     chronic renal anemia not currently treated with ESAs. Patients will receive intravenous~     Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last~     treatment visit. The anticipated time on study treatment is 3-12 months, and the target~     sample size is 100-500 individuals.~   "
215586|NCT00737698|"~     Background Chronic Obstructive Pulmonary Disease (COPD) patients develop leg weakness and a~     reduced walking capacity, due to reduced leg muscle oxygen-utilising capacity (OUC). Animal~     experiments indicate that low muscle levels of Peroxisome Proliferator-Activated Receptors~     (PPAR) cause the reduced muscle OUC.~      Aims~      In COPD patients, investigate whether:~        1. reduced muscle PPAR levels cause reduced leg muscle OUC, by investigating a correlation~          between these in muscle samples (Study 1).~        2. training increases muscle PPAR levels in proportion to increases in OUC, as should occur~          if PPARs control OUC (Study 2).~        3. muscle PPAR levels and walking capacity correlate (Study 1 and 2).~      3. the new technique of repetitive stimulation of the nerve to the leg with a magnet (rMS)~     improves muscle OUC (Study 2).~      Study 1 Leg weakness and walking ability are assessed in 75 patients, then a leg muscle~     sample is taken to measure PPARs and OUC.~      Study 2 60 Study 1 patients have either cardiovascular training, rMS, or no training, for 8~     weeks, then are re-studied as in Study 1.~      Importance If reduced PPAR levels correspond with leg weakness, medicines can be developed to~     target these receptors and treat weakness. If rMS is effective, it can be offered to~     patients.~   "
215587|NCT00737685|"~     Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the~     conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found~     to be more effective in preventing GVHD and rejection of organ transplants. As the~     fludarabine based conditioning regimens without total body irradiation have been reported to~     be promising for BMT/PBSCT from alternative donors in SAA, thymoglobulin was added to~     fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in~     UBMT/UPBSCT.~   "
215588|NCT00737672|"~     The objective of the study is to establish efficacy and safety of the GORE VIABAHN®~     Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV)~     prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of~     vascular access for hemodialysis.~   "
215641|NCT00736983|"~     To assess whether a combination of ciprofloxacin and adalimumab is more effective than~     adalimumab alone for the treatment of perianal fistulas in Crohn's disease~   "
215642|NCT00736970|"~     This clinical trial will study the use of ridaforolimus in metastatic breast cancer subjects~     whose tumors have shown a resistance to trastuzumab (herceptin). The goal of this study is to~     find out if subjects treated with ridaforolimus in combination with trastuzumab have a~     positive response to the treatment, and if treatment with ridaforolimus in combination with~     trastuzumab prolongs survival.~   "
220178|NCT00676897|"~     Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo~   "
215590|NCT00737646|"~     This study is a three-arm randomized controlled trial to implement and evaluate the relative~     effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused~     intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in~     primary care clinics. The study will also examine the relative effects of the intervention~     conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC~     screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social~     influence surrounding CRC screening among patients, clinicians, and clinical staff. The~     target population includes average-risk patients aged 50-75 years, clinicians, and clinical~     staff within the primary care setting. The intervention will be implemented within primary~     care clinics in two managed care organizations (MCOs). The intervention targets the following~     CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy,~     colonoscopy, and double contrast barium enema.~   "
215591|NCT00737633|"~     This study is an extension of a study that has been ongoing for 1 year. The purpose of this~     open label study is to see the how well type 2 diabetics respond to~     VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an~     extended period of time. All subjects eligible to enroll into this study will receive study~     drug.~   "
215592|NCT00737620|"~     The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis~     access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have~     been used for many years as a prophylactic drug therapy to prevent thrombosis but good~     clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal~     hyperplasia in animal models. Until recently there has been little success in clinical trials~     of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel~     blocking drugs. Recently a major breakthrough was done by GORE when introducing the new~     heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare~     between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and~     complication.~   "
215593|NCT00737607|"~     The study is a prospective outcome study to evaluate the effectiveness and treatment outcomes~     of microendoscopic decompressive laminotomy (MEDL) with objective evaluation tools. The~     patients who fulfill the selection criteria will be enrolled to collect the pre-operative~     clinical data including demographic data, image studies, and functional evaluation for~     neurological symptoms and disability.~      The patient will receive MEDL and post-operative follow-up will be arranged at 1 week, 1~     month, 6 months, and 12 months after the operation. All the collected data will be analyzed~     to evaluate the efficacy and treatment results of MEDL.~   "
215594|NCT00737594|"~     The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at~     two dose levels) as compared to placebo for lowering portal hypertension.~   "
215595|NCT00737581|"~     The purpose of this study is to characterize subjects' response to spinal cord stimulation~     with postural changes.~   "
215596|NCT00737568|"~     The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain~     suppression of viral replication to prevent the emergence of complications, which requires~     long-term therapy. Durable suppression of viral replication is achieved in the treatment of~     chronic viral diseases by preventing of the emergence of drug-resistant mutations. The~     clinical guidelines for the management of lamivudine resistant patients are variable. Some~     recommend switching to another agent without cross-resistance, while others recommend adding~     on another agent without cross-resistance. Limited clinical data exists to demonstrate~     whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for~     lamivudine resistant patients or if it should be used as part of a combination therapy~     regimen.~      This study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir~     DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants~     with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or~     without the rtL180M mutation) over a 240-week period. Participants in this study must be~     receiving lamivudine treatment at the time of enrollment.~   "
215597|NCT00737555|"~     The treatment of cancer often involves the use of more than one drug at the same time. In~     this study, patients are treated with the already marketed drug paclitaxel (administered~     every 3 weeks by infusion)and with the investigational drug CHR-2797 (given orally, once~     daily). The purpose of this study is to evaluate if it is safe to administer these two drugs~     together, and how well the combination is tolerated by patients. The first patients will~     receive a 90mg dose of CHR-2797; doses will be increased in subsequent patients, as long as~     they are adequately tolerated.~   "
215598|NCT00737542|"~     The objective of this prospective, double-blinded, placebo-controlled, randomized study is to~     evaluate the impact of preemptive analgesia using incisional site infiltration of lidocaine~     as compared to saline solution on post operative pain control in women undergoing cesarean~     deliveries.~   "
215599|NCT00737529|"~     To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle~     cell lymphoma who have relapsed, progressed or are refractory to bortezomib.~   "
215600|NCT00737516|"~     The National Marrow Donor Program (NMDP) has established a system for registering, matching,~     and tracking unrelated donor cord blood units (CBUs) and transplant outcomes. Study subjects~     are donors who enroll through collaborating cord blood banks. This study creates uniform~     collection, screening, testing and storage requirements for cord blood units. The purpose of~     standardization is to improve efficiency in the selection of cord blood units for~     transplantation.~   "
215643|NCT00736957|"~     The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride~     plus acetaminophen (JNS013) with long term administration in participants with chronic pain.~   "
215644|NCT00736944|"~     This phase two trial will determine the tumor response rate at the primary site and at~     involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given~     in combination with cisplatin and 5-FU in patients with local regionally advanced HNSCC.~   "
215645|NCT00736931|"~     The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam~   "
215646|NCT00736918|"~     This study will determine the effectiveness of continuous follow-up care by case manager in~     preventing further suicide attempts~   "
220266|NCT00675727|"~     This study examines the safety of treating patients with advanced stage melanoma with the~     vaccine CADI-05. In addition, preliminary data regarding the clinical response and immune~     response will be collected.~   "
215601|NCT00737503|"~     The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS)~     field area of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)~     to determine the population effectiveness of Rotarix in Bangladeshi children. Villages in~     both intervention and government comparison areas will be included in this evaluation. We~     propose to introduce Rotarix into half of the villages of the Matlab HDSS. In villages~     randomized to receive the vaccine, all eligible children will be offered Rotarix during their~     first two Expanded Programme on Immunization (EPI) visits, as would routinely be done if~     Rotarix were included in the Government EPI schedule. In villages randomized not to receive~     Rotarix, children will receive their EPI vaccinations exactly as they would have in the~     absence of this study. Administration of Rotarix will be conducted by regular EPI staff, but~     ICDDR,B study staff will be present to document informed consent and collect study-specific~     information. The Ministry of Health will be an active partner in this evaluation since they~     will be the agency which may follow up with any subsequent vaccine programme. Vaccination~     with Rotarix will be recorded on the infant's immunization card which is normally used by the~     EPI programme, but also on a separate study-specific data collection form.~      Vaccination with Rotarix will continue from study initiation through June 30, 2011.~     Surveillance for rotavirus gastroenteritis will occur at Matlab Diarrhoeal Hospital and the~     community treatment centres of the Matlab HDSS continuously throughout the study period.~     Diarrheal illness information collected through surveillance will be linked to Rotarix~     study-specific data through the subject's HDSS identification numbers. The primary study~     endpoint will be the occurrence of an illness episode of acute diarrhoea, among infants and~     children admitted to a medical facility, determined to be caused by wild-type rotavirus found~     in a stool specimen. At the end of the surveillance period, rates of this primary study~     endpoint among age-eligible infants will be compared for villages randomized to receive~     Rotarix versus for villages randomized not to receive Rotarix. We expect that the rates of~     rotavirus diarrhoea will be significantly lower among children from the vaccinated villages.~      The first participant was enrolled in the study on September 23, 2008. Till date (May 12,~     2010) a total of 2,882 participants have been enrolled and received first dose. 2,684~     participants received second dose of Rotarix. There were 1013 cases gastroentritis reported~     to diarrhoeal treatment centres among <2 years old children from the vaccinated and~     unvaccinated villages. There were six death cases among the children who received Rotarix~     vaccine. These death cases were not related to the vaccines/study products.~   "
215602|NCT00737490|"~     The purpose of this study is to determine whether using an echocardiogram (a painless test~     where ultrasound is used to see your heart) while using mild electrical stimulation from your~     own CRT-D device to stimulate the ventricles (the lower chambers of the heart) to squeeze one~     slightly earlier than the other will show a sustained increase your heart's productivity~     (Cardiac Output (CO)), following implantation of a Cardiac Resynchronization Device (CRT-D).~     We believe that squeezing some parts of the heart earlier than others may make the heart a~     stronger pump.~   "
215603|NCT00737477|"~     This single-arm study will assess the efficacy and safety of monthly administration of SC~     Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease~     on peritoneal dialysis. Participants currently receiving maintenance treatment with SC~     erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with~     the starting dose derived from the last weekly ESA they had been receiving.~   "
215604|NCT00737464|"~     This single arm study will evaluate the maintenance of hemoglobin levels, safety and~     tolerability of once-monthly intravenous administration of Mircera in dialysis patients with~     chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms)~     every four weeks depending on the previous dose of epoetin alfa administered in the week~     preceding first study drug administration. Patients will be treated for 12 weeks with follow~     up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12~     months, and the target sample size is 100-500 individuals.~   "
215605|NCT00737451|"~     Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria.~     About 5-34% of chronic urticaria patients is associated with the presence of thyroid~     autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or~     hypothyroidism.~   "
215606|NCT00737438|"~     This study is being done to find out how effective a new treatment strategy is on your~     cancer. In this strategy, the response your tumor has to the first cycle of therapy will help~     select the next treatments. We also will find out the effects, both good and/or bad, a drug~     called bevacizumab has on you and your tumor when given with chemotherapy.~   "
215607|NCT00737425|"~     The purpose of this study is to evaluate safety and efficacy of PainShield device, based on~     ultrasound technology, for postoperative pain relief and wound healing following a~     laparoscopic-assisted abdominal surgery.~   "
215608|NCT00737412|"~     The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing~     traveler's diarrhea.~   "
215609|NCT00737399|"~     Anxiety and depression have been found to be significant co-occurring conditions in cancer~     patients. This study examines these and other psychological conditions in patients diagnosed~     with cholangiocarcinoma, a rare cancer of the bile duct, with an average survival time of~     three to six months post-diagnosis. Participants are taught EFT in telephone and internet~     group coaching sessions, and have access to an online support forum. They complete the~     Mini-Mental Adjustment to Cancer Scale (Mini-MAC), EORTC Quality of Life scale, the PTSD~     checklist, the Patient Health Questionnaire, and a brief health checklist. Participants also~     provide medical records confirming their diagnosis, and markers, both before and after the~     study. The study is expected to enroll 20-15 cholangiocarcinoma patients, and use a~     within-subjects, time series, repeated measures design. Symptoms are assessed prior to~     coaching, after four, and again after eight weekly coaching sessions. Follow-ups will occur~     in one month, three months, and one year. It is hypothesized that a drop in the severity of~     co-occurring psychological symptoms, pain and insomnia may occur after EFT coaching.~   "
215610|NCT00737386|"~     The objective of the project is to study the pathogenesis of Leishmania tropica infection in~     a focus of infection, to learn about relationship of infection in humans with ecological~     factors such as infection in hyraxes reservoir hosts and vector sandflies~   "
215611|NCT00737373|"~     In this trial, FLOT will be evaluated as therapy option for elderly patients (>65 years) with~     advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is~     that FLOT is more effective than FLO in elderly patients with acceptable side effects.~   "
215612|NCT00737360|"~     The purpose of this study is to determine whether TAS-106 is effective to patients with~     recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.~   "
215613|NCT00737347|"~     The purpose of the study is to investigate the effectiveness of three lifestyle treatment~     programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain~     and to measure the composition of the change in body weight.~   "
215647|NCT00736905|"~     The purpose of this study is to investigate the pharmacokinetics (how the drug is absorbed~     into the bloodstream, distributed in the body and eliminated from the body) after a single~     dose and after repeated administration of TMC278 administered once daily for 11 days in~     subjects with mild or moderate hepatic impairment (impaired liver function), compared with~     healthy control subjects. Furthermore the short-term safety and tolerability (how well the~     body tolerates the drug) of TMC278 will be assessed.~   "
215614|NCT00737334|"~     A highly desired result during carotid endarterectomy (CEA) is the ability to predict and~     warn the surgeon if the brain is at risk of damage during the period of time that the carotid~     artery is cross-clamped for surgical repair of the vessel narrowing. A number of approaches~     for cerebral monitoring have been developed, including EEG, cerebral oximetry, and~     measurement of arterial to jugular venous concentration differences of oxygen, glucose or~     lactate. This study will utilize and compare multiple monitoring approaches for detecting~     when and if the brain is at risk of injury during CEA. As such, this robust approach to~     monitoring may permit a more prompt intervention to prevent or limit damage should cerebral~     ischemia occur. In this study we will compare a processed EEG monitor -- the EEGo, which uses~     nonlinear analysis to a bispectral (BIS) index monitor, and to the FORE-SIGHT cerebral~     oximeter to assess the ability of each to identify cerebral ischemia should it occur with~     carotid artery cross-clamping during CEA. These monitors will be correlated with arterial to~     jugular venous lactate concentration difference, which has recently been shown to be a~     sensitive indicator of hemispheric ischemia during CEA.~   "
215615|NCT00737321|"~     This pilot study is designed to assess the impact of ischemia/ diminished wound~     vascularization and stress on wound healing by comparing patterns of gene expression in~     specific cell types critical to wound healing biology, e.g. macrophages or endothelial cells.~   "
215616|NCT00737308|"~     The objectives of this study are to determine the clinical performance of zirconia-based~     dental prostheses and their related properties.~   "
215617|NCT00737295|"~     This is a prospective, non-randomized study of 50 people with suspected biliary dyskinesia.~     The purpose of this study is to investigate if it is possible to use ultrasound to make a~     diagnosis of a condition called biliary dyskinesia. The investigators null hypothesis is that~     there will be no statistical difference between the proposed experimental test (Ultrasound)~     and the HIDA scan (a nuclear medicine hepatobiliary system scan) in the diagnosis of biliary~     dyskinesia.~   "
215618|NCT00737282|"~     The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four~     months each) will be evaluated.~   "
215619|NCT00737269|"~     The purpose of this registry is to better understand (1) complicated skin and soft-tissue~     infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized~     patients receiving intravenous antibiotic therapy.~   "
215620|NCT00737256|"~     The purpose of this study is to gather systematic clinical data on whether aripiprazole, a~     partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence~     subjects. Since aripiprazole has established effects against schizophrenia, the study focuses~     on whether aripiprazole concurrently reduces co-morbid cocaine dependence in schizophrenia~     plus cocaine dependence sufferers compared to a standard typical antipsychotic treatment~     (perphenazine). The working hypothesis states that subjects in the aripiprazole treatment arm~     of the study will give fewer cocaine positive urine specimens as compared to the perphenazine~     control arm.~   "
215621|NCT00737243|"~     This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a~     carcinoma of unknown primary site (CUP) will have their treatment selected with the use of a~     molecular profiling assay. The assay will be performed on paraffin-embedded tumor tissue from~     a biopsy specimen. Patients given specific diagnoses (e.g., lung, pancreas, colon, breast,~     renal cell, prostate and ovarian cancer) will receive treatment regimens of proven activity.~     If no specific diagnosis is made with the molecular profiling assay, empiric chemotherapy~     with paclitaxel, carboplatin, bevacizumab and erlotinib will be administered.~   "
215622|NCT00737230|"~     RATIONALE: A step-by-step procedure may help health care practitioners diagnose and treat~     cancer patients with bowel injury symptoms caused by radiation therapy.~      PURPOSE: This randomized clinical trial is studying the care of cancer patients with bowel~     injury caused by radiation therapy to the pelvis.~   "
215623|NCT00737217|"~     This research study will evaluate functions of memory, thinking, behavior, and daily life~     activities and how these relate to the measurement of certain chemicals (acetylcholine and~     dopamine) in the brain using an imaging procedure called positron emission tomography (PET).~     You may know that in Alzheimer's dementia (dementia is a disease where persons become~     forgetful and confused), a reduction in the amount of acetylcholine, a neurotransmitter~     substance (a chemical messenger that nerve cells need to communicate with each other), may be~     responsible for some of the memory and behavioral changes. At the present time, the~     investigators have no clear information on the levels of acetylcholine in the brain of~     patients with Parkinson's disease who also have memory or behavioral changes.~   "
215624|NCT00737204|"~     This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is~     effective in reducing fatigue in adults with HIV/AIDS.~   "
215625|NCT00737191|"~     RATIONALE: Opioids lessen pain caused by cancer. It is not yet known whether opioids are more~     effective when given together with or without olanzapine in treating cancer pain.~      PURPOSE: This randomized clinical trial is studying opioids to see how well they work when~     given together with or without olanzapine in treating patients with moderate to severe cancer~     pain.~   "
215626|NCT00737178|"~     After medication abortion, women may quickly become pregnant again and therefore need an~     effective birth control method right away. Intrauterine devices (IUDs) are very effective for~     preventing pregnancy. IUDs are usually placed more than a month after abortion. This study~     will randomly assign women having a medication abortion to two groups, either having the IUD~     inserted one week after medication abortion or having the IUD inserted more than four weeks~     later. Women will be followed for six months to compare how many return for IUD placement in~     the two groups, how many are using the IUD after six months, experience with pain, bleeding,~     and cramping, how easy or difficult it is to insert the IUD, how many IUDs are expelled or~     removed, and how many women are using any birth control six months after the abortion.~   "
215627|NCT00737165|"~     1. The primary goal for this study is to examine the effectiveness of community-based~          multimodal intervention program for suicide prevention in relatively high suicide rate~          region compared to control region.~        2. The secondary goal for this study is to explore the effectiveness of community-based~          multimodal intervention program for suicide prevention in the highly populated regions.~          In addition, we examine the effectiveness of the prevention program in the all regions~          combined.~   "
215628|NCT00737152|"~     Rationale: RAS 130 is an anti-diabetic agent used to lower the blood glucose level in Type II~     Diabetes mellitus (non-insulin-dependent diabetes) patients with proper diet and exercise.~     RAS 130 works by restoring proper response to insulin in the body. RAS 130 acts primarily by~     increasing insulin sensitivity which improves glycemic index. It is presumed that RAS 130~     does not cause cardiovascular side effects if it is given to Type II diabetes mellitus~     patients leading a healthy life style. Specifically, controlling diet is done according to~     American Diabetic Association & American Heart Association guidelines and also through doing~     aerobic exercises. Guideline for aerobic exercise is given in the design of the study.~      Exercise is helpful in controlling body weight which can lower the risk for heart disease.~     Diabetes itself is one of the compounding factors for heart diseases. Exercise helps lowering~     the LDL cholesterol and raising the HDL cholesterol which is required to prevent heart~     diseases and achieve a better quality of life.~      Purpose: The aim of this study is to prospectively assess and evaluate the cardiovascular~     side effects and reduction of blood glucose levels in the Type II Diabetes mellitus patients~     treated with RAS 130, who either met, or failed to meet criteria for diet and exercise.~   "
215629|NCT00737139|"~     This study involves research. The purpose of this research is to formally investigate the~     hemostatic efficacy of epinephrine to minimize blood loss after total joint arthroplasty. It~     is unclear if using intra-articular injections of epinephrine in total joint replacement is~     associated with a decrease in post-operative blood loss. The initial hypothesis is: the use~     of intra-articular injection of epinephrine is associated with decreased post-operative blood~     loss.~   "
215630|NCT00737126|"~     The development of diabetic nephropathy has been linked to several genetic polymorphisms,~     including those related with homocysteine metabolism such as the methylenetetrahydrofolate~     reductase (MTHFR)and the cystathionine-beta-synthase genes. Such alterations are associated~     with hyperhomocysteinemia, which is a known independent risk factor for the development of~     endothelial dysfunction and cardiovascular disease.~      In the Mexican population there is a high prevalence of the C677T MTHFR mutation. The~     investigators performed this study to evaluate the prevalence of this polymorphism in type 2~     diabetic patients with diabetic nephropathy compared with type 2 diabetic patients without~     nephropathy, besides evaluating the relationship of hyperhomocysteinemia with endothelial~     dysfunction and microalbuminuria before and after the administration of folic acid. We~     proposed that the endothelial dysfunction caused by the hyperhomocysteinemia could be~     reversed after the administration of folic acid.~   "
215631|NCT00737113|"~     The primary objective of this study is to define the safety and efficacy of recombinant human~     growth hormone (rh-GH, Genotropin) in a patients undergoing allogeneic transplantation.~   "
215632|NCT00737100|"~     This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide~     (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on~     lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be~     based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations~   "
215633|NCT00737087|"~     This post-marketing study is designed to collect data relating to the use of the Delta Xtend™~     Total Shoulder Replacement System in shoulder with rotator cuff deficiencies. This allows for~     continued monitoring of the performance and safety of the prosthesis in a broader range of~     clinical situations.~   "
215634|NCT00737074|"~     Macular hole in proliferative diabetic retinopathy with fibrovascular proliferation may have~     unique features. Internal limiting membrane peeling facilitates hole closure only in cases~     with shallow macular detachment. Final vision is associated with preoperative visual acuity~     and degree of macula elevation.~   "
215635|NCT00737061|"~     The purpose of this study is to demonstrate the safety & efficacy of the Adiana Transcervical~     Sterilization System for women who desire permanent birth control (female sterilization) by~     occlusion of the fallopian tubes.~   "
215636|NCT00737048|"~     The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral~     dose administration in participants with pain after tooth-extraction of mandibular impacted~     wisdom tooth.~   "
215637|NCT00737035|"~     This study will determine whether a specialized Web site geared for the guardians of children~     whose one parent has murdered the other can increase guardian capabilities, reduce guardian~     stress, and improve child behavior and mental health.~   "
215638|NCT00737022|"~     Vitrectomy is one of the major treatment methods for complications of diabetic retinopathy.~     As surgical techniques and instruments improve, high anatomical success may be achieved;~     however, functional results are less favorable. Despite attached retina, postoperative visual~     function may be affected by various macular and disc abnormalities. Major changes include~     optic atrophy, atrophic retina, poor macular perfusion, and structural alternations of the~     macula. Funduscopy, fluorescein angiography, and, more recently, optical coherence tomography~     (OCT) can be used to detect and document these alterations. Although fluorescein angiography~     is valuable in the assessment of various macular lesions as well as retinal vascular~     abnormalities, its usefulness in evaluating macular changes is limited in eyes that have~     undergone diabetic vitrectomy. The quality of the images may be compromised by mild diffuse~     hyperfluorescence in the posterior pole in middle and late phase angiography, which obscures~     capillary detail and subtle macular changes. Furthermore, quantification of changes may not~     be possible. Recently, optical coherence tomography has become very useful for the detection~     of vitreomacular abnormalities. The examination is noninvasive, can qualify the changes and~     detect subtle abnormalities not evident with other imaging studies.~      In this study, OCT was applied to investigate how common macular structure abnormalities are~     present after surgery for complications of diabetic retinopathy, and how they may affect~     visual prognosis.~   "
215639|NCT00737009|"~     The purpose of this study is to describe adherence to anastrozole treatment current practice:~     cases where anastrozole treatment was halted ( timescale and causes) and estimate the~     proportion of postmenopausal women with early breast cancer who continue anastrozole therapy~     after one year follow-up.~   "
215640|NCT00736996|"~     The purpose of this study is to investigate novel treatments to delay progression to dementia~     in patients with mild cognitive impairment (MCI) and metabolic syndrome (MS). The hypothesis~     is that treatment with pioglitazone or endurance exercise training will improve, stabilize,~     or attenuate decline in cognitive function compared to controls. This study will also~     discover potential mechanisms for the improvements and determine the baseline prevalence of~     amnestic versus non-amnestic MCI.~   "
215651|NCT00736853|"~     The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride~     plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis~     (a progressive and degenerative joint disease, in which the joints become painful and stiff)~     of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which~     cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).~   "
215652|NCT00736840|"~     This trial is a pivotal trial to validate the use of a 13 C labeled substrate called~     methacetin and the BreathID automatic breath testing system, for determination of cirrhosis~     in patients with chronic liver disease.~   "
215653|NCT00736827|"~     The purpose of this study is to find out whether acute renal failure is associated with BK~     virus reactivation in postoperative/posttraumatic critically ill patients with severe~     SIRS/sepsis and shock.~   "
215654|NCT00736814|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. It is not yet known which~     combination chemotherapy regimen is most effective in treating non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is comparing different combination chemotherapy~     regimens to see how well they work as first-line therapy in treating patients with stage IIIB~     or stage IV non-small cell lung cancer that cannot be removed by surgery.~   "
215655|NCT00736801|"~     BDNF has been linked to the pathogenesis of airway hyperresponsiveness in asthma. In this~     trial, the impact of a treatment with salmeterol and salmeterol / fluticasone on BDNF~     concentrations will be assessed in patients with asthma. The investigators hypothesize that~     salmeterol impacts on BDNF concentrations in patients with asthma.~   "
215656|NCT00736788|"~     The primary objective of this study is to investigate the safety and tolerability of AZD1704~     following single ascending doses in healthy Japanese male and non-fertile female volunteers~     by assessment of adverse events (AEs), vital signs (supine and standing blood pressure, pulse~     rate, respiratory rate and body temperature), safety laboratory variables and 12 lead~     electrocardiography (ECG). The secondary objectives of the study are: to investigate the~     subjective CNS effects of orally administered AZD1704 in healthy Japanese male and~     non-fertile female volunteers on a psychometric rating scale by assessment of specific~     adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale~     (VAMS) and to investigate the pharmacokinetic profile of AZD1704 following single ascending~     doses in healthy Japanese male and non-fertile female volunteers.~   "
215657|NCT00736775|"~     This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will~     be conducted in the United States and consists of a single ascending-dose stage followed by a~     multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult~     patients between 50-85 years old who have mild to moderate Alzheimer's disease.~   "
215658|NCT00736762|"~     The postural alterations present in the seniors people act as predisponent form of~     incapacities that provoke alterations in the quality of life. The objective of this study is~     to evaluate the biomechanical characteristics of the balance of elderly people, before and~     after treatment with Global Postural Re-education. This research is characterized by~     experimental method of investigation.Thirty elderly people (30 women) will be randomized to~     two different groups from Group of Studies of Third Age - GETI, at University of the State of~     Santa Catarina:~        -  fifteen elderly women will be submitted to the Global Postural Re-education (GPR)~          program and to the GETI program of activities~        -  fifteen elderly women will be submitted only to the GETI program of activities.~      At baseline the subjects will be screened for balance measurements with the chattecx balance~     system and Berg Scale. These measurements will be repeat immediately after the intervention.~     The subjects randomised to the GPR program will participate in posture retraining techniques~     of approximately forty minutes, one time a week for ten weeks. The independent t test for~     pairs of random samples will be used, with level of significance of p≤0,05.~   "
215659|NCT00736749|"~     This clinical trial keeps track of and collects follow-up information from patients who are~     currently enrolled on or have participated in a Children's Oncology Group study. Developing a~     way to keep track of patients who have participated in Children's Oncology Group studies may~     allow doctors learn more about the long-term effects of cancer treatment and help them reduce~     problems related to treatment and improve patient quality of life.~   "
215660|NCT00736736|"~     The first purpose was to compare the difference between leg press exercise(LPE) and~     additional hip abductor and external rotator muscle strength training to leg press~     exercise(LPE+HAE) in muscle strength, hip kinematics during step down, pain severity and~     function for patients diagnosed with patellofemoral pain syndrome. The second one was to~     discover the relationship between the change in muscle strength performance and the~     difference of hip joint kinematics post treatment.~   "
215661|NCT00736723|"~     The purpose of this study is to determine the course of NT-proBNP plasma concentrations in~     the context of confounding parameters in postoperative/posttraumatic critically ill patients~     with severe SIRS/sepsis and shock.~   "
215662|NCT00736710|"~     Patients with schizophrenia have high rates of cigarette smoking and tobacco dependence, and~     great difficulties in quitting smoking. The development of novel and more effective~     treatments for tobacco dependence in this population is thus needed. This study will test the~     hypothesis that repetitive transcranial magnetic stimulation (rTMS) may facilitate smoking~     cessation with the transdermal nicotine patch (TNP) in patients with schizophrenia motivated~     to quit smoking. A total of N=40 smokers with schizophrenia would be assigned to either~     active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatments for four~     weeks. All subjects would receive TNP (21 mg/24h) and weekly group behavioral therapy for~     smoking cessation for a total of 10 weeks. The investigators predict that active rTMS will be~     well-tolerated and superior to sham rTMS for enhancing smoking cessation rates in smokers~     with schizophrenia.~   "
215663|NCT00736697|"~     The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on~     the concentrations of moxidectin measured in the blood after a single oral administration in~     healthy subjects.~   "
215664|NCT00736684|"~     The purpose of this study is to compare rates of any fracture fixation complication and~     revision rates after intramedullary fixation of unstable trochanteric fractures between the~     Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3)~     (Control Group).~   "
215665|NCT00736671|"~     This research study will evaluate functions of memory, thinking, eye movements and walking~     and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in~     the brain using an imaging procedure called positron emission tomography (PET). You may know~     that the brain chemical dopamine, a neurotransmitter substance (a chemical messenger that~     nerve cells need to communicate with each other), is important for the brain to control~     movements and that the brain chemical acetylcholine may have functions related to mental~     concentration and attention. At the present time, the investigators have no clear information~     how these two chemicals in the brain of patients with Parkinson's disease are related to the~     risk of falling.~   "
215666|NCT00736658|"~     This is a single centre, double-blind, randomised, parallel group, placebo controlled study~     to assess the safety, tolerability and pharmacokinetics of AZD1386 when given as multiple~     doses to 32 (24 healthy young and 8 healthy elderly) Japanese subjects. For young healthy~     subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are~     planned. For elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is~     planned.~   "
215667|NCT00736645|"~     RATIONALE: Selenomethionine may slow the growth of prostate cancer. Testosterone can cause~     the growth of prostate cancer cells. Finasteride may fight prostate cancer by lowering the~     amount of testosterone the body makes. Giving selenomethionine together with finasteride~     before surgery or radiation therapy may be an effective treatment for prostate cancer.~      PURPOSE: This randomized phase II trial is studying how well selenomethionine and finasteride~     work when given before surgery or radiation therapy in treating patients with stage I or~     stage II prostate cancer.~   "
215668|NCT00736632|"~     In recent years, vitamin D has been shown not only to be important for bone and calcium~     metabolism but also for homeostasis of critical tissues involved in vascular disease in~     patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D~     deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease~     and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the~     effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D~     deficient hypertensive patients with diabetes~   "
215669|NCT00736619|"~     For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®)~     + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this~     standard regimen of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are~     chemotherapy drugs which are administered by vein.~      Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells~     when given alone or in combination with chemotherapy. The purpose of this study is to~     establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab~     and radiation therapy. The investigators want to find out what effects, good and/or bad, the~     albumin-bound paclitaxel has on you and your head and neck cancer.~   "
215670|NCT00736606|"~     The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and~     simvastatin (single dose) when co-administered in healthy volunteers~   "
215671|NCT00736593|"~     Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular~     communication at the wound site, thereby promoting accelerated healing, reducing inflammation~     and pain. This randomized double-blind study will assess the safety, tolerability and~     clinical effect of Nexagon™ when applied to skin wounds created by punch biopsy in healthy~     volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled.~     Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and~     wound appearance evaluation.~   "
215672|NCT00736580|"~     This study is assessing whether there is a decrease in surgical glove punctures using blunt~     tipped needles compared with sharp needles for suturing during Cesarean Delivery.~   "
215673|NCT00736567|"~     PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which~     will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and~     mortality. The pathogens detected on DEC include Salmonella, Campylobacter jejuni, Shigella~     species, and Escherichia coli O157:H7. This study will evaluate the performance of the assays~     and the platform in clinical conditions with non-expert users. It will provide important data~     on the performance of DEC for at least one target pathogen, an understanding of the potential~     impact of different sample types on device performance, and human factors associated with~     instrument interface in the field.~   "
215674|NCT00736554|"~     Staphylococcus aureus is the most common bacteria responsible for skin, bone, and muscle~     infections. Recent studies from the United States have suggested that a type of this~     bacterium called methicillin resistant S. aureus (MRSA) has become dramatically more common,~     especially the community strain. However, Canadian data is still largely lacking. This study~     aims to determine the prevalence of community acquired (CA) MRSA among patients presenting~     with skin and soft tissue infections to the Urgent Care Center and Emergency Departments in~     London, Ontario. This will be determined by taking swabs at enrollment from patient's noses,~     throats, and sites of infection. Patients will be asked to complete a health questionnaire~     with the goal of identifying risk factors associated with CA-MRSA. Through follow-up swabs of~     participants' noses and throats at one and three months, the effects of treatment on~     patient's carrying MRSA will be determined. Results may be used to form guidelines for~     empirical S aureus treatment in the region, reducing possible morbidity and mortality from~     delayed or suboptimal treatment of CA-MRSA infections. Improved understanding of risk factors~     associated with MRSA infection in a Canadian setting, may also change the practice of~     physicians considering empiric antibiotic therapy for skin and soft tissue infections.~   "
215700|NCT00736203|"~     The purpose of this study is to obtain a database of brain function from a sample of~     non-smokers while they do tasks in an MRI (magnetic resonance imaging) machine. Our~     hypothesis is that among nonsmokers, reactivity to smoking cues will be highly similar to~     control cues but may vary as a function of attitudes toward smoking and/or family history of~     smoking. We also hypothesize that brain activity during the n-back task will be more similar~     to data collected during this task when smokers are not abstinent.~   "
215701|NCT00736190|"~     The purpose of this study is to evaluate the antiviral activity and safety of tenofovir~     disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in~     the United States) with chronic hepatitis B infection. All participants will receive active~     treatment with TDF for 48 weeks.~   "
215675|NCT00736541|"~     N-acetylcysteine (NAC) is used to treat Tylenol toxicity. NAC is a rich source of the~     sulfhydryl group (SH) which is important for replenishing the body's glutathione stores.~     Glutathione acts as a free radical scavenger, to decrease the damage that would be caused by~     those toxic radicals. Patients who undergo orthotopic liver transplantation (OLT) have a high~     incidence of post-operative renal dysfunction. The most common etiology of post-operative~     renal dysfunction is related to high levels of toxic free radicals. Free radicals may~     contribute to primary liver graft failure or delayed liver graft function.~      Specific Aims & Objectives:~      The primary objective of this study is to evaluate the efficacy of NAC in improving liver~     graft performance and lowering the incidence of post-operative renal dysfunction. The~     secondary objectives are to investigate the effect of NAC on endogenous glutathione body~     stores and its effect on FK506 induced toxicity.~   "
215676|NCT00736528|"~     To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration~     of multiple, ascending, oral doses to healthy elderly subjects.~   "
215677|NCT00736515|"~     In recent years, with the further research of the pathogenesis of diabetes mellitus and the~     mechanism of oral antidiabetes drugs, the early combination therapy of oral antidiabetes~     drugs and insulin is getting paid more and more attention. A lot of studies have confirmed~     that Gliclazide MRs have excellent reducing blood glucose efficacy and vascular protection.~     Based on these theory and practice, this study is designed to demonstrate whether the~     combination therapy of Gliclazide MR and basal insulin can control the blood glycemia~     effectively and reduce the dosage of insulin and the hypoglycemia events compared to the~     premix insulin monotherapy.~   "
215678|NCT00736502|"~     The aim of this trial is to evaluate the safety and virological and immunological efficacy of~     Viramune® on a background of different antiretroviral drug combinations.~   "
215679|NCT00736489|"~     The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199~     in asthmatic patients.~   "
215680|NCT00736476|"~     To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine,~     compared with placebo.~   "
215681|NCT00736463|"~     Summary:~      Background: There is a lot of interest in the function and role of HDL to prevent and~     mitigate atherosclerosis in patients who are at or near LDLc targets. Statins have variable~     effects on HDLc which are accentuated in patients with a low baseline HDLc. Higher doses of~     statins are being used more commonly in practice based on newer outcomes studies which find~     greater benefits of the higher doses compared to lower or standard doses. This study is~     testing FDA approved dosages of two commonly used statin medications.~      Design: The study is designed to examine the effects of 80mg simvastatin and 80mg~     atorvastatin on HDLc concentrations. Serum will be saved for a hopeful collaborative effort~     with investigators at the U. of Washington who are able to do more advanced testing of HDL~     particle functionality. Based on the first 13 patients studied at Indiana University, the~     effects of these statins on HDLc concentrations vary greatly. It is unknown what impact these~     concentration changes have on the functionality of the particles however. A meta-analysis of~     4 prospective trials published in JAMA in 2006 found that increasing HDLc with statins was~     independently associated with regression of atherosclerosis as measured by intravascular~     ultrasound.~      Patients: Patients with low HDLc will be the primary population recruited. Exclusion criteria~     include interacting medications, pregnancy, baseline hepatic disease or other illnesses which~     would put patients at increased risk of statin side effects.~   "
215682|NCT00736450|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Oblimersen sodium may~     help chemotherapy work better by making cancer cells more sensitive to the drugs. Giving~     oblimersen sodium together with combination chemotherapy may kill more cancer cells. PURPOSE:~     This clinical trial is studying the side effects of giving oblimersen sodium together with~     combination chemotherapy and to see how well it works in treating patients with newly~     diagnosed stage I, stage II, stage III, or stage IV diffuse large B-cell lymphoma~   "
215683|NCT00736437|"~     The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the~     time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions~     experimentally induced after ultra violet radiation (UVR) exposure.~   "
215684|NCT00736424|"~     The purpose of this study is to collect subject data to evaluate the rate of sudden~     unexplained death in epilepsy (SUDEP) with bilateral neurostimulation of the anterior nucleus~     of the thalamus in people diagnosed with refractory epilepsy. The data obtained from the~     physician initiated studies will be pooled with data collected in Medtronic-sponsored studies~     to assess SUDEP risk.~   "
215685|NCT00736411|"~     The aim of this investigation is to determine the value of combining acupuncture with~     infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure~     the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and~     pregnancy and live birth rates.~   "
215686|NCT00736398|"~     This is an observational study to assess clinical outcomes in patients who undergo spinal~     fusion. Patients who are already scheduled for spinal fusion will enroll in the study.~     Information about prior therapies will be collected, and then patients will be followed to~     see how they do after spinal fusion. This study will help researchers better understand the~     natural course of patients who patients who undergo spinal fusion surgery.~   "
215687|NCT00736385|"~     The purpose of this study is to find out if Metformin is safe and useful in the treatment of~     NAFLD.~   "
215688|NCT00736372|"~     PX-12 (1-methylpropyl 2-imidazolyl disulfide) is a novel small molecule inhibitor of~     thioredoxin-1, a small protein over-expressed in many human cancers that is associated with~     aggressive tumor proliferation, angiogenesis, and drug resistance. This study is being~     conducted to determine the maximally tolerated dose of PX-12 delivered as a 72-hour infusion~     over days 1, 2, and 3 of a 21-day cycle in patients with advanced or metastatic cancer.~   "
215689|NCT00736346|"~     The purpose of this study is to assess the impact of three different treatment modalities on~     panic symptoms, quality of life and use of health services among individuals consulting an~     emergency department for non cardiac chest pain and having Panic Disorder.~   "
215690|NCT00736333|"~     This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of~     metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar~     erythrodysesthesia (PPE).~   "
215693|NCT00736294|"~     Atrial Flutter [AFL] is a relatively frequent arrhythmia, considered as benign, but~     associated with both invalidating symptoms and thromboembolic risk. The objective of the~     treatment consists to on the one hand the sinus rhythm [SR] restoration and on the other hand~     the prevention of the long-term recurrence. In this clinical setting, AFL radiofrequency~     ablation [RFA] became the first line therapy due to its both high effectiveness and safety.~     The effectiveness of AFL RFA is attenuated by the subsequent risk of atrial fibrillation~     [AFib] close to 25% at 1 year. This risk of subsequent AFib is related to the common~     substrate between both arrhythmias.~      When AFib occurs, the interest to maintain the SR is still required, even if recent studies~     did not show a significant difference in term of total mortality between rate or rhythm~     control strategies [AFFIRM, RACE and PIAF studies]. The studies published underlined the~     anti-arrhythmic drugs limits in patients with both arrhythmias [AFib and AFL]. After years~     centered on the mechanisms and the electric treatments of AFib, researchers are nowadays~     focusing on the study's evaluation of the atrial tissue substrate.~      Accordingly, the renin-angiotensin system role was investigated in many works. Indeed,~     angiotensin II plays a role in the modification of atrial pressure and in the fibers~     stretching [stretch], conditions required for the development of AFib. Angiotensin II is~     also a factor implied in the tissue fibrosis leading to tissue proliferation and collagen~     alteration. These mechanisms lead to atria cells conduction disorders and refractory periods~     modification. Moreover, the enzyme of conversion expression and the angiotensin II receptors~     deterioration were observed in patients with AFib.~      This brings to the concept of AFib treatment while interfering on tissue remodeling by the~     way of renin-angiotensin system. Drugs such as the angiotensin converting enzyme inhibition~     [ACEI] may reduce AFib in patients with heart failure. No randomized study so far has~     compared the ACEI drugs against placebo among high-risk patients of AFib in post AFL RFA~     area. On the basis of experimental and clinical study, the investigators seek to evaluate the~     ACEI use in the prevention of AFib in an AFL post RFA ablation.~   "
215694|NCT00736281|"~     The questions proposed by this study are those of safety and efficacy.~        1. Concerning safety: Are sublingual food drops (SLIT) safe enough to be used for~          stimulation of natural immune suppression in patients with food allergies?~        2. Concerning efficacy: Do the drops suppress food allergy enough for patients to eat~          previously allergic foods with little or no allergic reaction?~      The aim of this trial is to provide systematic collection of data proving the safety and~     efficacy of food drops in the correction of food allergy. A patient's range of symptoms,~     which can include but are not limited to fatigue, nausea, vomiting, diarrhea, abdominal pain,~     and insomnia can be diagnostic indicators of food allergies.~      An approach to answering the above questions can be done by a randomized, controlled, blinded~     study. The design of our study could be reasonable and powerful because this layout limits~     bias and accounts for placebo effects:~      The patients enrolled in our study will present with food allergy symptoms and diagnostic~     tests will provide the specific information regarding their food allergies. Once the~     diagnosis has been made and consent for treatment has been obtained, participants will be~     randomly assigned to either the group that receives the food allergy intervention with SLIT (~     food allergens mixed with 50% glycerin in a vial) or the group that receives the control SLIT~     (glycerin only). The patients are truly blinded to their treatment because all the SLIT food~     allergy vials are identical and contain no distinguishing features that could reveal their~     contents. There is also no difference in taste between a vial containing glycerin and food~     allergens and a vial containing only glycerin. Therefore, a food allergy SLIT~     randomized-controlled study can be reasonably achieved.~   "
215695|NCT00736268|"~     This study is an NIH-funded clinical trial conducted at Duke University Medical Center and~     Ohio State University. The purpose of this study is to examine the effects of a~     telephone-based, care-giver assisted, coping skills training (CST) program in patients with~     Chronic Obstructive Pulmonary Disease (COPD) and their caregivers. This may help COPD~     patients and their caregivers to deal better with the stress of lung disease. This study will~     test 3 primary hypotheses: 1) That enhanced CST will be more effective in improving quality~     of life compared to a Usual Medical Care plus COPD education and symptom management control~     group; 2) That enhanced CST will be associated with better medical outcomes (i.e., greater~     survival and fewer COPD-related physician visits or hospitalizations) compared to Controls~     over a follow-up period of up to 4 years; and 3) That improvements in quality of life and~     survival will be mediated by increased functional capacity and better coping.~      This proposed study builds upon our prior research by: a) adapting and refining our CST~     protocol, which was effective in improving psychosocial adjustment in patients awaiting lung~     transplantation, to a broader population of patients with COPD who are not immediate~     candidates for lung transplantation; b) enhancing our intervention to improve functional~     capacity, reduce somatic symptoms, and improve survival; c) examining the impact of CST on~     medical expenditures; and d) including caregivers in an enhanced CST intervention.~   "
215696|NCT00736255|"~     The overall goal of the present project is to investigate whether lisdexamphetamine (LDX;~     Vyvanse) is an effective adjunct to nicotine replacement therapy (NRT) to promote smoking~     cessation in patients with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and~     nicotine dependence. The investigators hypothesized initially that smokers with ADHD who are~     optimized to a dose of LDX prior to quitting smoking and who remain on this dose of~     medication after quitting will remain abstinent longer than patients who are treated with~     placebo before and after quitting.However due to recent key issues that have arisen showing~     that initiation of stimulant treatment while subjects are actively smoking may facilitate~     increased smoking, and given that the study was still in the very early stage of study~     execution, the investigators revised the study design to use an empirically validated~     pretreatment approach with NRT and to initiate LDX treatment on the first post quit date in~     order to reduce the withdrawal symptoms that accompany smoking cessation. The overall~     rationale for this revised study design remains similar to the original.~   "
215697|NCT00736242|"~     The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b~     (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human~     Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by~     general practitioners in clinical practice as part of the post-marketing surveillance study.~     The study assessed the rates of eradication of the HCV and the rates of serious adverse~     events reported with PEG-IFN alfa-2b (1.5 ug/kg/week) and RBV (800-1200 mg/day) in common~     medical practice in Germany.~   "
215698|NCT00736229|"~     The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in~     hyperglycemic patients admitted to the coronary intensive care unit.~   "
215699|NCT00736216|"~     RATIONALE: Learning about young adults' knowledge and perceptions about risk factors for the~     human papilloma virus and cervical cancer may help doctors learn more about how to prevent~     human papilloma virus infection and cervical cancer in the future.~      PURPOSE: This clinical trial is studying knowledge and perceptions of the risk factors for~     human papilloma virus infection and cervical cancer in young adults.~   "
215702|NCT00736177|"~     This study seeks to determine if patients with a history of failed fresh embryo transfer(s)~     will have increased success rates with embryo cryopreservation and subsequent thawed embryo~     transfer when compared to fresh embryo transfer.~   "
215703|NCT00736164|"~     RATIONALE: Selenomethionine may slow the growth of prostate cancer. Giving selenomethionine~     before surgery or internal radiation therapy may be an effective treatment for prostate~     cancer.~      PURPOSE: This randomized phase II trial is studying how well selenomethionine works in~     treating patients undergoing surgery or internal radiation therapy for stage I or stage II~     prostate cancer.~   "
215704|NCT00736151|"~     The purpose of this study is to examine the effects of various increasing doses of~     Ralfinamide in patients with neuropathic pain.~   "
215705|NCT00736138|"~     Effects of training and pellots~   "
215706|NCT00736125|"~     The purpose of this study is to determine if the use of a carbon dioxide lavage device~     (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic~     events when compared with standard orthopedic techniques.~   "
215707|NCT00736112|"~     The questioned proposed by this study is one of treatment: To what extent does simultaneous~     BMT (Bilateral Myringotomy with Tympanostomy Tubes), adenoidectomy, and diagnosis/avoidance~     of food allergy affect the frequency of recurrent otitis media (ROM) versus the standard~     academy approach (tube insertions only) to chronic otitis media with effusion; furthermore,~     are adenoids a factor in OME or is food allergy diagnosis and treatment able to significantly~     prevent ROM after the tubes fall out?~      The trial seeks to provide evidence that the treatment for Chronic OME in children should~     involve surgical procedures (BMT +/- adenoidectomy), as well, as a food allergy work-up and~     subsequent avoidance of the offending foods in order to significantly decrease ROM.~      To answer this question, a prospective, randomized controlled trial needs to be conducted.~     Since a majority of OME patients are from the pediatric population, parental consent must be~     obtained. Subjects in our study will initially present to the clinic with otitis media~     symptoms and diagnostic tests such as a tympanogram, otoscopy, and history of recurrent~     otitis media will be obtained. Once the surgical decision for bilateral myringotomy and~     tympanostomy tubes has been made, parents will be informed about the trial. The standard~     protocol for children presenting with initial Chronic OME is to perform a BMT. Therefore,~     data from the control group (Group 1) will be obtained from faculty ENT who follow the~     academy's recommendations. Data from Group 2 and 3 will be collected from other ENT faculty~     members, including the faculty co-investigator who will perform the BMT and obtain a food~     allergy blood draw at the time of surgery. The study's faculty co-investigator will describe~     food avoidance techniques to post-op patients from Groups 2 and 3. Patients with previous~     adenotonsillar surgery or placement of tympanostomy tubes will not be enrolled in the study.~     The incidence of ROM episodes in all trial groups will be recorded.~   "
215708|NCT00736099|"~     The objective of the current study is to investigate the safety and tolerability of BI 1356~     (5 mg / once daily) given for 78 weeks in different modalities of treatment.~      The treatment modalities are determined by the treatment in the blinded trial in which every~     patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI~     1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin~     background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin~     in combination with a sulphonylurea (patients in 1218.18 study)~   "
215709|NCT00736086|"~     To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous~     diagnostic procedure.~   "
215710|NCT00736073|"~     The purpose of this study is to determine if giving Aprepitant 4 hours before and for two~     days after ERCP decreases the risk of developing pancreatitis after ERCP.~   "
215711|NCT00736060|"~     This study will summarized the clinical and laboratory data and the outcome of all the~     patients suffering from Sickle Cell Anemia (Including Sickle cell thalassemia) admitted to~     the pediatric ward.~   "
215712|NCT00736047|"~     This study is designed to determine the efficacy of high nicotine-specific antibody titers in~     smoking cessation.~   "
215713|NCT00736034|"~     The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to~     improve cognitive performance in elderly subjects with memory impairment.~      This study is a single-center, open-label 15 weeks duration trial to assess efficacy of~     Phosphatidylserine-Omega3 in elderly subjects with memory impairment.~   "
215714|NCT00736021|"~     The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of~     chronic post-traumatic stress disorder (PTSD) in adult civilian survivors of traumatic~     events.~      Forty survivors of carefully documented traumatic events who had been followed for more than~     two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve~     weeks~      Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical~     impression, as well as emergent side effects will be recorded every two weeks (one week for~     the first four weeks.~      The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or~     the last meeting with the patient - Last Observation Carried Forward).~      The secondary outcome criteria will be treatment continuation, as expressed in the proportion~     of patients leaving the study for either lack of effect or side effects.~   "
215715|NCT00736008|"~     The study will assess the clinical and laboratory data of about 100 pediatric patients~     diagnosed and treated at the Pediatric Hematology Unit during the years 1980 until 2007~     because of thrombotic events.~      The results, the treatment given, and the outcome of the patients will be summarized.~   "
215716|NCT00735995|"~     The purpose of this study is to assess the effectiveness of a cognitive-behavioral~     intervention for children aged 7 to 12 years with anxiety disorders who are referred to~     ordinary community clinics. The treatment will be conducted as individual therapy or group~     therapy.~   "
215717|NCT00735969|"~     This study will evaluate the effectiveness of an experimental treatment regimen for hepatitis~     C (HCV). Standard treatment consists of combination therapy with ribavirin, taken by mouth~     twice a day, and Peginterferon, injected under the skin once a week. Hepatitis C genotypes 2~     and 3 have a high success rate with this regimen, while genotype 1 is more difficult to~     treat. This study will determine if patients with genotype 1 respond better to treatment that~     uses a higher dose of ribavirin than the standard approved dose of 1,000 to 1,200 mg daily.~      Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been~     successfully treated with a standard course of Peginterferon and ribavirin may be eligible~     for this study. Participants eligible will receive Peginterferon plus twice the standard dose~     of ribavirin (2,000 to 2,400 mg daily) for 48 weeks. In addition to treatment, all patients~     receive undergo the following:~      Before Treatment:~        -  Medical history and physical examination, symptom questionnaires, blood tests, urine~          collection, chest x-ray, electrocardiogram, liver ultrasound, Fibroscan (ultrasound to~          measure stiffness of the liver) and pregnancy test for women who are able to have~          children.~        -  Patients with other medical conditions or special risk factors may have further~          evaluations before starting treatment. These may include, for example, eye evaluation~          for patients with diabetes, exercise stress test for people over age 40 or who have risk~          factors for heart disease and psychiatric evaluation for people who have depression or~          anxiety disorder.~      During Treatment~        -  Periodic blood tests to monitor blood counts and viral levels.~        -  Outpatient clinic visits every 4 weeks for the duration of the study for laboratory~          tests and review of symptoms and treatment side effects. Physical examinations and urine~          tests are done every 12 weeks.~      Following Completion of Treatment~      About 1 1/2 years after starting treatment, subjects are re-evaluated as they were at the~     start of treatment.~   "
215718|NCT00735956|"~     Purpose of the study:~      This is a pilot randomized controlled trial to identify methods of involving underage youth~     in interventions to reduce alcohol use through the primary health care system. The trial will~     compare the effectiveness of using an onsite behavioral health specialist for screening,~     intervention and referral with basic written information and staff recommendations typically~     provided in primary care offices.~   "
215719|NCT00735943|"~     The objective of this observational study is to evaluate the effectiveness and safety of~     Macugen for treatment of wet age-related macular degeneration (AMD) in Indian~     patients.Prospective, Observational, Non-interventional Study. The period of observation for~     the study will be 1 year~   "
215720|NCT00735930|"~     This phase I trial studies the side effects and best dose of lenalidomide when given together~     with alvocidib in treating patients with relapsed or refractory B-cell chronic lymphocytic~     leukemia or small lymphocytic lymphoma. Lenalidomide may stop the growth of leukemia or~     lymphoma by blocking blood flow to the cancer. Alvocidib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Giving lenalidomide together with~     alvocidib may kill more cancer cells.~   "
215721|NCT00735917|"~     This phase II trial is studying how well saracatinib works in treating patients with~     previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
215722|NCT00735904|"~     This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows~     activity and is safe in patients with squamous type of non-small cell lung cancer~   "
215723|NCT00735878|"~     Primary Objectives:~      The primary objectives of this study are as follows:~      • To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of~     escalating ABT-751 in combination with fixed dose carboplatin in patients with advanced non~     small cell lung cancer (NSCLC).~      • To evaluate the efficacy of the combination with ABT-751 and carboplatin in patients with~     advanced NSCLC~      • To determine the median survival in the study population~      Secondary Objectives~      The secondary objectives are:~      • To characterize the pharmacokinetic profile of ABT-751 given in combination with~     carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2.~      • To determine the pharmacodynamics of ABT-751 as a single agent and the combination of~     ABT-751 and carboplatin as evaluated by cell cycle analysis of buccal mucosa cells.~   "
215724|NCT00735865|"~     To determine if the types and amount of bacteria or other germs change over time after the~     routine procedure of blockage of tear drainage duct in the treatment of dry eye condition or~     other condition benefiting from a tear drainage blockage~   "
215725|NCT00735852|"~     This is a single-centre, open-label, within patient comparison study to assess the efficacy~     and safety of Decapeptyl SR when administered in combination with Livial for the treatment of~     women with chronic cyclical pelvic pain. This will be for a 2 year period with a 6 month post~     treatment follow up. The study aims to recruit 40 patients.~   "
215726|NCT00735839|"~     This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.~   "
215727|NCT00735826|"~     The primary aim is to study the effects of vorinostat on cyclin E, cyclin D1 and Ki-67~     expression in lung, bronchial epithelium, and lung tumors of patients with resectable~     clinical stage I - III lung cancer. Secondary aims are: To evaluate the concentration of~     vorinostat in tumor tissue and to correlate lung tissue distribution with the plasma level in~     these patients; to perform exploratory analyses of the effects of vorinostat on the induction~     of apoptosis or necrosis in treated as compared to untreated tumors and on expression of p21,~     p27, EGFR and phospho-EGFR in lung tumors of patients with resectable clinical stage I - III~     lung cancer; to perform dynamic contrast enhanced CT of the primary tumor to study the~     effects of treatment on the vascular supply of the tumor and to correlate the results with~     the intratumoral vorinostat concentrations.~   "
215728|NCT00735813|"~     Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire~     duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent~     complications of long term TCVC are catheter related blood steam infections. Taurolock is a~     new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been~     demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs~     locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the~     number of CRBSI in children with cancer compared with children with heparin lock of their~     CVC.~   "
215729|NCT00735800|"~     Caring for a patient with dementia is associated with increased feelings of burden and~     depression. The proposed study will examine the efficacy of Family Intervention: Telephone~     Tracking - Dementia (FITT-Dementia), a multi-component, family-based, telephone intervention,~     as a tool to reduce caregiver stress.~   "
215730|NCT00735787|"~     Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to~     placebo in adults with chronic plaque psoriasis of the hands and/or feet and the~     sustainability of response for 12 additional weeks.~   "
215731|NCT00735774|"~     The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron~     emission tomography tracer.~   "
215732|NCT00735761|"~     The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence~     in immunocompromised patients treated with ME-609 or Acyclovir.~   "
215733|NCT00735748|"~     The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol~     perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during~     the first 6 hours postoperatively and to investigate the time course and accuracy of pain~     relief versus the onset and duration of side effects. The first unit dose will be~     administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is~     reached. The second and third unit dose will be administered after 1 and 2 hours,~     respectively, when a VAS of more than 3 is observed.~   "
215734|NCT00735735|"~     The purpose of this study is to compare the levels of Substance P in saliva, in patients with~     severe chronic low back pain and in subjects without it. In addition, to explore a possible~     cutoff point, in order to define normal and pathological levels of Substance P in saliva. The~     ultimate objective would be to design a measurement method for use in routine clinical~     practice.~   "
220347|NCT00674661|"~     Prospective, randomized multicenter study to determine the safety and effectiveness of~     performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with~     ectasia after refractive surgery.~   "
215735|NCT00735722|"~     Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF~     undergoing CABG will be superior in restoring SR, compared with patients with persistent or~     long standing persistent AF undergoing CABG treated with best medical treatment according to~     ACC/AHA/ESC 2006 guidelines and no AF ablation.~   "
215736|NCT00735709|"~     The purpose of this study is to determine the effectiveness and safety of vortioxetine, once~     daily (QD), in patients with Major Depressive Disorder.~   "
215737|NCT00735696|"~     The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months~     of ramucirumab administered in combination with paclitaxel and carboplatin as first-line~     therapy for Stage IIIB or IV non-small cell lung cancer~   "
215738|NCT00735683|"~     This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss~     over a 12-week period.~   "
215739|NCT00735670|"~     This study was initially designed to test the efficacy of Venlafaxine HCl in reducing~     incidence of the onset of major depression after a new spinal cord injury (SCI). After~     several protocol modifications, the purpose of the study is to test the effectiveness of a~     sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with~     SCI.~   "
215740|NCT00735657|"~     Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for~     patients undergoing Pars Plana Vitrectomy.~   "
215741|NCT00735644|"~     This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in~     toddlers aged 12-18 months.~      Primary objective:~      To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi~     pasteur.~      Secondary objective:~      To describe the safety of vaccination in all subjects~   "
215742|NCT00735631|"~     The aim of this study is to investigate the accuracy, safety and robustness of a~     single-input-single output (SISO) model-based predictive closed-loop system to guide~     patient-individualized ICU sedation.~   "
215743|NCT00735618|"~     Primary:~        -  To characterize the physiologic changes of the autonomic nervous system, demonstrated by~          heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a~          15 minute, one-time, guided relaxation program for cancer patients.~      Secondary:~        -  To assess whether change of HRV correlates with subjective feeling for anxiety, based on~          visual analog scale scores.~   "
215744|NCT00735605|"~     Comparative study between surgical and non surgical treatment of anismus in patients with~     symptoms of obstructed defecation.~      Anismus is a significant cause of chronic constipation. This study came to compare the~     results of BFB training , BTX-A injection and PDPR in the treatment of anismus patients.~     Patients and methods: Seventy two anismus patients fulfilled Rome II criteria for functional~     constipation were included in this study. All patients underwent anorectal manometry, balloon~     expulsion test, defecography, and electromyography activity of the EAS. All patients had non~     relaxing puborectalis muscle.. The patients were randomized into three groups. Group I~     patients received biofeedback therapy, two times per week for about 1 month. Group II~     patients were injected with BTX- A. Group 111 partial division of puborectalis was done.~     Follow up was conducted weekly in the first month then monthly for about 1 year.~   "
215745|NCT00735592|"~     The study intends to assess the utility of performing a follow up X rays in children admitted~     to pediatric wards with lobar pneumonia. Usually those children are discharged with a~     recommendation for a follow up X rays but there are no enough studies proving that this~     recommendation is really necessary.~   "
215746|NCT00735579|"~     This clinical observational study investigates the incidence of wound healing abnormalities~     in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing~     deficits may be accompanied by abnormalities in blood coagulation parameters.~   "
215747|NCT00735566|"~     Endogenous antiangiogenic factors are related with gastric cancer progression.~   "
215748|NCT00735553|"~     Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex~     25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness~     between 50 mg versus placebo, and between 25mg and placebo will be analyzed.~   "
215749|NCT00735540|"~     This study intends to analyze the clinical characteristics of teenagers admitted to pediatric~     wards due to organic illness and non organic diagnosis, including patients suffering from~     chronic diseases and comorbidity.~   "
215750|NCT00735527|"~     Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening~     and requires rapid termination. Early and effective treatment is essential to prevent the~     morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of~     care for control of SE when administered by intra-venous (IV) route. The investigators intend~     to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of~     administration of lorazepam. In resource poor settings, sometimes trained personnel or~     appropriate equipment for intra-venous cannulation is not available. Alternate routes of~     administration, if shown equivalent to conventional IV route, will be very useful in such~     settings or for out of hospital management of seizures in children.~   "
215751|NCT00735514|"~     RATIONALE: Understanding how well patients comply with their treatment regimen may help~     doctors determine best treatment and ongoing care for future patients.~      PURPOSE: This phase I study is looking at compliance with vaginal dilation therapy in women~     who have undergone radiation therapy for stage IB, stage IIA, stage IIB, stage IIIA, or stage~     IIIB cervical cancer or stage IA, stage IB, stage IIA, or stage IIB endometrial cancer.~   "
215752|NCT00735501|"~     This observational study is conducted in Europe. The study aims to observe the incidence of~     serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.~   "
215753|NCT00735488|"~     Since 1987, a screening for β Thalassemia in pregnant women is carried on in northern Israel,~     and from 1999 all the samples were tested also for Hgb S, Hgb C, Hgb D, Hgb O Arab and~     others.~      In this study, the investigators intend to summarize the results of this preventive program~     aiming to detect couples at risk for having offspring with Thalassemia or SCA, the compliance~     regard to genetic counseling and prenatal diagnosis and the incidence of new affected babies~     born.~   "
215754|NCT00735475|"~     The purpose of this study is to determine the immunogenicity and safety profile of CSL~     Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus~     Vaccine.~   "
215755|NCT00735462|"~     The purpose of this study is to determine whether imiquimod creams are effective in treating~     external genital warts (EGW). The secondary objective of this study is to provide information~     on recurrence of EGW. Additionally the study will also look at any adverse events associated~     with the use of the creams.~      External genital and perianal warts are caused by the infection of human papillomavirus or~     HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like~     small flesh-colored, pink, or red growths on or around the external skin of sex organs or~     perianal area. The warts may look similar to the small parts of a cauliflower or they may be~     very tiny and difficult to see. They often appear in clusters of three or four, and may grow~     and spread rapidly. They usually are not painful, although they may cause mild pain,~     bleeding, and itching.~   "
215756|NCT00735449|"~     Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive~     therapy to Xalatan in subjects with glaucoma or ocular hypertension.~   "
215757|NCT00735436|"~     The primary objective of the study is to use 24 week survival to assess the efficacy of the~     combination of Gliadel followed by Avastin and irinotecan in the treatment of grade IV~     malignant glioma patients following surgical resection. The secondary objectives are to~     determine the progression-free survival following the combination of Gliadel followed by~     Avastin and irinotecan and to describe the toxicity of Gliadel followed by Avastin and~     irinotecan.~   "
215758|NCT00735423|"~     The purpose of this study is to identify neurocognitive functions and language processing of~     8-year-old children who were fed either breast milk, milk-based formula or soy-based formula~     during the first year of life.~   "
215759|NCT00735410|"~     Annual trial for registration influenza vaccine with the strain composition for season~     2008/2009~   "
215760|NCT00735397|"~     The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12~     mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to~     evaluate the maintenance of effect of perampanel for the control of refractory partial~     seizures.~   "
215761|NCT00735384|"~     The primary aim of the project is to apply the non-invasive stimulated muscle force~     assessment system to i) intensive care unit patients and ii) patients with primary myopathy~     or subclinic myopathy (e.g., Duchenne muscular dystrophy, Myotonia, MH). The investigators~     will use this new methodology of force assessment to phenotype patients weakness during their~     illnesses (depict typical force pattern) and monitor recovery periods, or disease~     progression, respectively. This new system will be evaluated until the year 2018. The~     investigators will determine variables of isometric skeletal muscle force.~      These systems should serve as force monitoring tools and help to guide therapies.~   "
215762|NCT00735371|"~     The study will evaluate the efficacy of LDX treatment group compared to placebo on the change~     from Baseline ADHD-RS-IV score at endpoint.~   "
215763|NCT00735358|"~     The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the~     preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high~     following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices~     more effectively and achieve better hemostasis.~   "
215764|NCT00735345|"~     The aim of this study is the evaluate the feasibility and safety of chemotherapy induction~     treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in~     the treatment of patients with non-metastatic esophageal cancer.~   "
215765|NCT00735332|"~     The objective of this study is to assess the efficacy and safety of TLN-232 used to treat~     patients with metastatic melanoma that recur/progress after receiving first line systemic~     therapy.~   "
215766|NCT00735319|"~     Jaundice is the most frequent reason for readmission for healthy newborns after discharge~     from the nursery. In the Capital Health area, around 2.5% (315 babies in 2005) of all healthy~     newborns were admitted to the hospital for jaundice. Although jaundice is very common, it is~     not always a benign condition. If left untreated, it can have devastating consequences~     including cerebral palsy and hearing loss. It is therefore critical to be able to identify~     the newborns at risk for severe jaundice. So far, heel puncture of blood collection has been~     the traditional method to monitor jaundice in newborns. This causes pain to infants,~     generates anxiety in parents, and consumes significant health care resources. The aim of this~     study is to evaluate the efficacy of a new and noninvasive screening tool, the transcutaneous~     bilirubinometer, in detecting babies in our communities who require hospital readmission.~     This study will demonstrate whether incorporating transcutaneous bilirubinometer in the home~     care program delivered by nurses of Healthy Beginning allows the early detection of babies at~     risk of developing severe jaundice at a lower cost and with less discomfort.~   "
215767|NCT00735306|"~     The primary purpose of this trial is to define the maximum tolerated and/or recommended phase~     II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy~     for carcinoma of the pancreas. An additional primary objective is to describe the frequency~     and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary~     objectives include describing 1-year disease-free survival and overall survival rates as well~     as to estimate clinical and pathologic complete response rates associated with this regimen.~   "
215768|NCT00735293|"~     Patients with excessive underarm odor and sweating and/or odor are treated with the VASER~     system to determine the VASER's effectiveness in reducing underarm sweat and odor~   "
215769|NCT00735280|"~     The aim of this trial is to evaluate whether a reduction in the heparin dose from 140 to 100~     U/kg is associated with a better net clinical outcome in patients undergoing PCI after~     pretreatment with 600mg clopidogrel~   "
215770|NCT00735267|"~     This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD~     0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety~     Disorder.~   "
215771|NCT00735254|"~     The purpose of this study is to examine the effect of using a pulsed dye laser (the VBEAM), a~     non-ablative laser (the Affirm) and a combination of both lasers to improve the appearance of~     your surgical scar. Both the pulsed dye laser and Affirm laser are approved by the US Food~     and Drug Administration (FDA) for the treatment of scars. Surgical scars are a type of scar~     that can benefit from laser therapy. Redness and the appearance of small blood vessels near~     the surface of the skin (telangiectasias) develop in such scars as part of the normal healing~     process and usually spontaneously remit, but often slowly and incompletely. In many cases,~     lasers can accelerate the clearing of this redness and also improve scar texture.~   "
215772|NCT00735241|"~     This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising~     a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres~     (chemo-radiotherapy, also known as chemo-SIRT), in combination with the biologic therapy~     Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from~     colorectal carcinoma in whom surgical resection is not feasible.~   "
215773|NCT00735228|"~     Hyperglycaemia has been repeatedly associated with risk of mortality and morbidity in the~     intensive care unit (ICU). The evidence currently available is in favour of a 'normal ≤ 6.1~     mmol/l' level for blood glucose control in ICUs according to two large randomized control~     trials of Van den Berghe G and is not supportive of J. Miles's viewpoint in this debate. In~     this study, the investigators would like to evaluate that the target of blood glucose level,~     whether is a normal level (80-110 mg/dL) or another level (140-160 mg/dL), should be set for~     the reduction of perioperative mortality and complications.~   "
215774|NCT00735215|"~     The sequential administration of endocrine therapies to patients with advanced breast cancer~     requires the availability of therapies with different modes of actions, so that tumours~     developing resistance to one agent are not cross resistant to another. Because of its~     mechanism of action, fulvestrant is distinct from other hormonal therapies, which therefore~     limits the possibility of cross-resistance with other therapies such as tamoxifen and the~     aromatase inhibitors (AIs)~        -  In this way, patients may benefit from an extended period of endocrine treatment, which~          has considerable tolerability and quality-of-life advantages over cytotoxic~          chemotherapy.~        -  In Belgium, fulvestrant is indicated for treating postmenopausal women with hormone~          receptor-positive locally advanced or metastatic breast cancer with recurrence during or~          after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen~          treatment. However, little information is currently available on how fulvestrant is~          actually being used by physicians in Belgium. The optimum sequence of endocrine~          treatment for advanced breast cancer has yet to be defined and may depend on certain~          patient or disease characteristics.~      Fulvestrant has been granted reimbursement by the Belgian Health authorities (RIZIV/INAMI)~     with the recommendation to collect the real life data necessary to assess the patients'~     breast cancer treatment history that may influence the actual endocrine treatment sequence~     according to physicians current clinical practice..~   "
215775|NCT00735189|"~     Warfarin is a medication typically referred to as a blood thinner and is used to prevent the~     formation of blood clots, and hence prevent life-threatening events such as strokes and clots~     on the lungs (known as pulmonary emboli). This therapy is only safe and effective if the~     degree of blood thinning is kept within a narrow window - if the blood is too thick clots~     may form but if the blood is too thin the risk of bleeding increases. Complicating the~     control of warfarin is that different people require different amounts of it to have an~     appropriate degree of blood thinning, and once this amount is determined for a patient, it~     may be changed by factors that are encountered on a daily basis (i.e., diet, acute and~     chronic diseases, alcohol, medications, etc.). As such, regular monitoring is necessary to~     confer the benefits of this medication. Our Anticoagulation Management Service (AMS) has~     demonstrated really good control of blood thinning therapy by working with patients to inform~     them of the rationale for this medicine, the factors having the ability to impact its~     control, and encouraging the patient to be involved in their care (via provision of tools to~     document test results, one-on-one education and access to our program at any time with~     questions, etc.) Currently, our AMS has to limit the volume of patients seen due to resource~     limitations. As such, it is imperative that we investigate alternate strategies to manage~     these patients. Paramount, however, is that any long-term strategy must not confer inferior~     control of warfarin. The purpose of this study is to determine if the impact of AMS Care is~     sustained following the transfer of anticoagulation management to the family doctor.~     Operationally, the results of this study will guide future management of patients. If control~     of warfarin therapy declines with family doctor management, alternate strategies, such as~     patient self-management, will need to be investigated in a larger scale trial.~   "
215776|NCT00735176|"~     The study will compare cervical arthroplasty with cervical discectomy and fusion, in the~     treatment of cervical radiculopathy. The 0-hypothesis is that there is no difference between~     the two methods, when comparing primary and secondary outcome variables.~   "
215777|NCT00735163|"~     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.~     Recently, large randomized controlled trials have demonstrated that tight glycaemic control~     (TGC) reduces morbidity and mortality in this population. Based on this emerging evidence~     intensive insulin therapy is currently finding its way into the critical care practice.~      In the meantime numerous insulin infusion protocols, which are based on frequent bedside~     glucose monitoring, have been implemented. Recent reviews comparing different types of~     protocols describe widely ranging practice and difficulties in achieving TGC despite~     extensive efforts of the intensive care unit (ICU) staff. A fully automated algorithm may~     help to overcome some of these limitations by excluding intuitive interventions and~     integrating relevant clinical data in the decision-making process. The primary objective of~     the current study is to investigate the performance (efficacy) of a control algorithm for~     glycaemic control in ICU patients for the whole length of ICU stay.~   "
215778|NCT00735150|"~     We are inviting you to participate in a study of how people who have had genetic counseling~     for breast/ovarian cancer risk feel about certain reproductive technologies, preimplantation~     genetic diagnosis (PGD) and prenatal genetic diagnosis (PND), that may reduce the chances of~     passing increased risk onto one's children. We would also like feedback from patients who~     have been to our clinic in the past on the best ways to talk about PGD and PND during genetic~     counseling sessions. We are seeking both the opinions of people who are interested in these~     technologies and those who are not. It does not matter whether you have heard of PGD or PND~     before - you can still participate. Your past experience with genetic counseling is valuable~     to us in deciding how to communicate this information during sessions.~   "
215779|NCT00735137|"~     The aim of the study is to determine the effect of cerclage pessary on the incidence of~     spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic~     women with singleton pregnancies found at routine mid-trimester screening to have a cervix of~     <25 mm in length and in twin pregnancies.~   "
215780|NCT00735124|"~     The study will investigate the effects of single dose pre-operative oral dose of gabapentin~     (1200) on post -operative pain scores and oral analgesic requirements.~   "
215781|NCT00735111|"~     The purpose of this study is to determine if patients are able to self-rate their physical~     abilities and how these ratings compare to the ratings of their health-care provider.~   "
215806|NCT00734786|"~     The main objective of the trial is to determine whether the current topical formulation of~     GTX 2/3 reduces the wrinkling of the skin (crow's feet) after a single application~      Other evaluation criteria include: safety assessment and local tolerance, depth of facial~     wrinkles (video microscopy imaging).~   "
215782|NCT00735098|"~     Knee Osteoarthritis (OA) is one of the most frequent causes of physical disability and pain~     among adults. Recent evidence suggests that shorter exercise programs that incorporate~     kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and~     functional improvements in comparison to traditional therapeutic exercise. KBA techniques are~     designed to improve dynamic joint stability by using a series of activities which challenge~     balance and coordination. To determine the independent effects of KBA training on functional~     abilities, it is necessary to test it as a training program unto itself. The proposed~     clinical trial is designed to do this by using three training groups: KBA only; lower~     extremity strength training only; and a combination of the two. The total exercise time and~     intensity of each condition will be approximately equal. A non-exercise group will control~     for any effects related to the testing procedures and the passage of time. Community~     volunteer men and women age 50 and over with physician diagnosed symptomatic knee OA will~     participate.~   "
215783|NCT00735085|"~     A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate~     the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential~     Cohorts of Patients with Moderate and Severe Traumatic Brain Injury.~   "
215784|NCT00735072|"~     Many people with HIV fail to regain normal CD4 counts despite effectively suppressing HIV~     replication with medications. Blocking the co-receptor for HIV might decrease inflammation~     of the immune system, potentially providing an immune benefit. The goal of the current trial~     is to determine whether adding maraviroc, a new CCR5 co-receptor blocker, decreases~     inflammation, providing an immune benefit for patients with low CD4 counts despite~     undetectable viral loads on HIV medications.~      In this study, HIV-infected patients who are receiving antiretroviral therapy for HIV will~     receive either maraviroc or a placebo (sugar pill) each day for 24 weeks. After 24 weeks, the~     study medication will be stopped and all subjects will be followed for 12 more weeks. Blood~     tests measuring the extent of inflammation, low-level viremia, and immune function will be~     measured throughout the trial and compared between treatment arms.~   "
215785|NCT00735059|"~     A current trend in dialysis membrane engineering is to maximize the permeability for larger~     low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do~     not meet these requirements. Particularly in convective procedures, such as~     hemodiafiltration, their albumin leakage is too high [10]. POLYNEPHRON™, the membrane which~     is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by~     applying an innovative spinning technique. The incentive of its development was to improve~     the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile~     for low-molecular weight proteins without significant loss of essential larger proteins at~     best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the~     planned study is to demonstrate the superior performance at lower albumin loss in different~     dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with~     regard to the removal of the whole range of uremic toxins.~   "
215786|NCT00735046|"~     A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive~     behavioral therapy for patients with early dementia.~   "
215787|NCT00735033|"~     The objective of this study was to investigate the effects of the Swiss ball on patients with~     hemiplegia due to CVA.~   "
215788|NCT00735020|"~     This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside~     mixing formulation of adjuvanted influenza vaccines.~   "
215789|NCT00735007|"~     The Electronic Device - The RebiSmart™ is an electronic injection device that is being~     studied for the delivery of Merck Serono's Rebif® New Formulation. The RebiSmart™ device is a~     stand-alone hand-held device with internal power supply. It is used for subcutaneous (under~     the skin) injections with single-use sterile disposable needles. The device will be kept in a~     storage box and placed in the refrigerator after each use.~      The key features of the RebiSmart™ are as follows:~        -  Battery powered electromechanical automatic injector;~        -  Automatic needle attachment and detachment;~        -  Hidden needle before and after injection;~        -  Injection can only be initiated by pressing the injection button when in contact with~          the skin;~        -  Automatic needle insertion and injection of the preset dose into the subcutaneous (under~          the skin) tissue;~        -  Adjustable injection comfort parameters: Injection depth, needle insertion speed,~          medication injection speed and time that the needle remains in the skin ;~        -  Cartridges with 3 doses of Rebif® New Formulation; and~        -  Several other electronic functions including history (date and time) of cartridge~          changes and injections.~      The Study Drug - Rebif® New Formulation (RNF) Rebif® is a medicine that is part of a family~     of proteins called interferon beta-1a (IFN-β-1a) molecules that play an important role in the~     immune system and help limit the damage that occurs with multiple sclerosis (MS). The~     interferon in Rebif® is like your body's own natural human interferon, but is made outside~     the body by a process called recombinant DNA technology. Merck Serono International S.A.~     (the maker of Rebif®) has recently updated the method to make Rebif®, and it is referred to~     as Rebif® New Formulation (RNF).~      For the purpose of this study, the form of Rebif® New Formulation (RNF) will differ slightly~     from the one you currently receive. RNF will be supplied in pre-filled cartridges containing~     three doses of 44mcg / 0.5 ml IFN-β-1a. This is the amount required for you to administer~     during the course of one full week of treatment. The dosage of RNF 44mcg is injected under~     the skin three times per week. The RebiSmart™ device will be provided for the administration~     of RNF. RNF should be administered, if possible, at the same time (preferably in the late~     afternoon or evening) on the same three days (e.g. Monday, Wednesday, and Friday), with at~     least 48 hours break between each administration. You will be asked to record the time and~     date of each injection in the diary cards provided. You will be taught how to properly use~     the device to inject the medication. You will also be reminded to rotate injection sites and~     advised on the importance of avoiding already inflamed areas for future injections.~      The goals of this research trial are:~        -  To evaluate if the electronic device can be used (if it is suitable) by MS patients~          performing self-injections of Rebif® New Formulation.~        -  To determine MS patients overall satisfaction of the new RebiSmart™ device by~          determining their ease in using it, how often side effects happen (flu-like symptoms,~          injection site reactions and any other overall injection issues) that they may~          experience while on the trial. This will be done by completion of the Patient User Trial~          Questionnaire and the Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ).~        -  To evaluate specific features of the RebiSmart™ device from the answers MS patients~          provide in the User Trial Questionnaire. The MS patient and the person who will trains~          them on the proper use of the device will complete this questionnaire.~   "
215790|NCT00734994|"~     Hypothesis: In selected patients external hyperthermia will be used in combination with~     intravesical Mitomycin-C (MMC) to treat recurrent transitional cell carcinoma (TCC) of the~     bladder after local resection and standard adjuvant therapy and thus prevent or delay~     recurrence and the need for radical cystectomy.~   "
215791|NCT00734981|"~     Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for~     evaluating semen quality.~   "
215792|NCT00734968|"~     This project will determine whether post-operative prophylaxis with macrobid will decrease~     the incidence of postoperative urinary tract infection in women receiving sub-urethral slings~     for the treatment of urinary incontinence.~   "
215793|NCT00734955|"~     Our objective is to develop a novel optical assay system for intra operative assessment of~     tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown~     that optical techniques can effectively discriminate between malignant and non-malignant~     breast tissues. We have also shown that data collection and processing from a single point on~     the tissue specimen requires less than 5 seconds. In addition, the technique is easily~     adaptable to provide sensing depths that are required for breast margin assessment. The goal~     of the work proposed in this protocol is to test the sensitivity and specificity of an~     optical assay system developed by our group, for intra operative assessment of breast tumor~     margins.~   "
215794|NCT00734942|"~     The purpose of this study is to develop and implement evidence-based and family-oriented~     support for young carers and their families in Germany. Hypothesis is that families' own~     support mechanisms, combined with externally provided support that is determined by the~     families' specific needs, will help to overcome their burden and enable families to live in~     the way they wish to despite chronic illness. This will lead to a measurable increase in~     HRQOL of children concerned.~   "
215795|NCT00734929|"~     We hypothesize that the combination of aprepitant with dexamethasone will provide~     significantly improved prophylaxis against Postoperative nausea and vomiting compared with~     the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under~     general anesthesia.~   "
215832|NCT00734448|"~     Myo-Inositol is an insulin sensitizing agent that ameliorate the insulin resistance in women~     affected by gestational diabetes (GDM), but there is no information about the effect on the~     glucose profile. Maternal hyperglycemia of GDM, especially hypoglycemic excursions, are~     associated with adverse pregnancy outcome. Continuous Glucose Monitoring System (CGMS) is~     obviously better than intermittent self monitoring in detecting glucose profile and magnitude~     and duration of glucose fluctuations. For this reason, we propose a clinical trial to analyze~     the characteristics of glucose variability in GDM women,treated with diet and folic acid~     alone or with diet, folic acid and myo-inositol supplementation.~   "
215833|NCT00734435|"~     The purpose of this study is to determine if zonisamide SR will prevent weight gain in~     schizophrenic subjects who take olanzapine (Zyprexa)~   "
215796|NCT00734916|"~     Immune modulating properties of parenteral lipid emulsions seem to contribute to the~     increased risk for infections which remains associated with the use of total parenteral~     nutrition. Emulsions based on soy bean oil (SO) are the oldest and still most widely used~     lipid source in TPN formulations but their high content of omega-6 polyunsaturated fatty~     acids (PUFAs) may be a drawback. Fish oil-based lipid emulsions (FO), rich in omega-3 PUFAs,~     has been approved for parenteral nutrition in many countries. Mainly retrospective studies on~     clinical outcomes in septic and postoperative patients have suggested clinical benefits with~     the inclusion of FO in parenteral nutrition regimens. The exact mechanisms behind the~     beneficial immunological effects of parenteral FO have, however, not yet been elucidated.~      Objective:~      To evaluate the effects of intravenous infusion of a FO-based lipid emulsion and a SO-based~     emulsion on immune function as evidenced by effects on peripheral blood leukocyte counts and~     functions and on the susceptibility to oxidative stress.~      Study design:~      Randomized placebo controlled cross-over pilot study with healthy volunteers.~   "
215797|NCT00734903|"~     The purpose of this study is to examine in Veterans the efficacy of an evidence-based~     gender-specific treatment model for women with substance use disorder (SUD).~   "
215798|NCT00734890|"~     RATIONALE: Vandetanib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and~     vandetanib may also stop the growth of cancer cells by blocking blood flow to the cancer.~     Giving vandetanib together with bevacizumab may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and~     bevacizumab in treating patients with advanced solid tumors or lymphoma.~   "
215799|NCT00734877|"~     Toward improving the therapeutic index of standard TT3 (S-TT3), the investigators will employ~     a randomized Phase III trial design to determine whether S-TT3 treatment-related toxicities~     can be reduced by 50% in TT3-Lite (L-TT3).~      Note: Randomization has been discontinued and accrual is closed to the L-TT3 arm. This trial~     is currently enrolling as a single-arm trial for patients to receive S-TT3.~   "
215800|NCT00734864|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose~     limiting toxicity (DLT) of dasatinib when combined with protracted, daily temozolomide (TMZ).~     Secondary objectives are: To further evaluate the safety and tolerability of dasatinib plus~     protracted, daily TMZ; 2. To evaluate the pharmacokinetics of dasatinib when administered~     with protracted, daily TMZ among recurrent malignant glioma patients who are on and not on~     CYP-3A enzyme inducing anti-epileptic drugs (EIAEDs); 3. To evaluate for anti-tumor activity~     with this regimen in this patient population.~   "
215801|NCT00734851|"~     This is a single arm phase II study of docetaxel, prednisone, and sunitinib systemic therapy~     followed by salvage external beam radiation therapy for men who have experienced PSA~     recurrence following initial radical prostatectomy for prostate cancer. The primary aim is~     the rate of progression-free survival at 2 years as measured by lack of PSA progression and~     no evidence of disease. We hypothesize that this aggressive initial systemic therapy will~     improve the long term remission rates for men who are undergoing salvage radiation therapy~     for PSA recurrence in the absence of metastatic disease.~   "
215802|NCT00734838|"~     The objective of the proposed research is to develop new diagnostic modalities based on~     optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of~     breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery~     part of the study, all patients scheduled to have a mastectomy or lumpectomy for the~     treatment of breast cancer will be asked if they would be willing to participate in this~     study. For the core needle biopsy part of the study, patients with a higher pre-probability~     of cancer (based on mammography) will be recruited to increase the number of patients with~     malignant lesions and enrolled in this investigation.~   "
215803|NCT00734825|"~     The purpose of this study is to compare IV contrast only vs. IV and oral contrast Computed~     Tomography (CT) for the diagnosis of acute appendicitis in adult patients in our emergency~     department. A secondary purpose will be to design a specific CT for appendicitis protocol at~     our institution at the conclusion of this study.~   "
215804|NCT00734812|"~     The purpose of this research study is to evaluate whether there is any difference in recovery~     time and return to normal activities following a laparoscopic supracervical hysterectomy~     (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of hysterectomies are~     commonly performed at our institution.~      Patients will be assigned by chance (like a coin toss) to have either a LSH or a TLH.~     Preoperatively, participants will complete a quality of life questionnaire (SF-36), a sexual~     function questionnaire (FSFI)and a 3 question questionnaire about urinary function (3IQ).~      Following surgery participants will be asked to keep a diary of pain symptoms and use of~     narcotics. The diary will be filled out daily until patients have resumed normal activities~     from prior to the surgery. The SF-36 will be completed again 6 weeks following the original~     surgery.~      6 months following surgery participants will receive a copy of the SF-36 and the FSFI in the~     mail. They will also be asked questions about urinary symptoms and persistent vaginal~     bleeding.~   "
215805|NCT00734799|"~     A substantial number of US Veterans are suffering from Posttraumatic Stress Disorder (PTSD)~     following deployment in recent military conflicts, and sleep disturbance is a primary~     complaint of Veterans presenting to the VA with PTSD. Veterans with PTSD have more~     self-reported and physician-rated health problems, and health status is associated with PTSD~     symptom severity. Most Veterans meeting criteria for PTSD report difficulty initiating or~     maintaining sleep (70-91%), and increased PTSD severity is associated with increased sleep~     disturbance. Even after receiving treatment for PTSD, Veterans continue to experience~     residual insomnia at a rate of about 50%, in spite of having achieved PTSD remission.~      There are currently no PTSD-specific sleep interventions available, excepting an intervention~     that is specific to nightmares. Given the prevalence of sleep disturbance in Veterans with~     PTSD, the absence of interventions for PTSD-related sleep problems, and the increasing number~     of post-deployment Veterans with trauma-related sleep difficulties, such interventions are~     desperately needed. In this study, we will test the effectiveness of a multi-component~     cognitive-behavioral sleep intervention for PTSD that targets both nightmares and insomnia~     for improving the overall sleep experience of Operation Iraqi Freedom (OIF) and Operation~     Enduring Freedom (OEF) Veterans with PTSD who are also receiving usual care. The primary~     objective is to pilot test the intervention for efficacy in reducing sleep disturbance. The~     secondary objective is to examine the relative impact of the intervention on PTSD symptoms.~     The project is a prospective, randomized, clinical intervention trial. Participants will be~     randomly assigned to a multi-component cognitive-behavioral sleep intervention for PTSD +~     Usual Care, or Usual Care alone. We are hypothesizing that 1) Veterans receiving the sleep~     intervention plus usual care will produce greater improvements (reduced total wake time,~     increased sleep efficiency, etc) in subjective sleep measures than will Usual Care alone; 2)~     Veterans receiving the sleep intervention plus usual care will produce greater improvements~     in nightmare frequency and severity than will Usual Care alone; and 3) the relationship~     between PTSD symptoms and treatment group will be significantly related to sleep quality in~     the period intervening baseline and follow-up.~   "
215807|NCT00734773|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Radiation therapy uses high-energy x-rays to kill cancer~     cells. Motexafin gadolinium may make cancer cells more sensitive to radiation therapy and~     combination chemotherapy. Giving motexafin gadolinium together with chemotherapy, rituximab,~     and radiation therapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects of giving motexafin gadolinium~     together with combination chemotherapy, rituximab, and whole-brain radiation therapy and to~     see how well it works in treating patients with newly diagnosed primary central nervous~     system lymphoma.~   "
215808|NCT00734760|"~     This study was conducted to test whether a focused education and counseling intervention~     delivered by a nurse will decrease time of delay in seeking treatment for the signs and~     symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as~     having ischemic heart disease.~   "
215809|NCT00734747|"~     The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling~     system for the treatment of GERD.~      The system allows the operator to staple the stomach to the esophagus,in order to restore the~     gastroesophageal flap valve. The effect of the stapling is similar to a common operation for~     GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is~     not needed.~      The hypothesis of the study is that the treatment will be effective in improving GERD related~     quality of life by 50% or more in the majority of the subjects, and that the procedure will~     be as safe as surgery.~   "
215810|NCT00734734|"~     Trial for annual approval of interpandemic influenza vaccines~   "
215811|NCT00734721|"~     1. Intravitreal injection can induce perioperative stress for the patients.~        2. Different factors can modulate the pre-operative fear and physiologic reaction.~   "
215812|NCT00734708|"~     This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast~     growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to~     evaluate the safety of such stimulation.~   "
215813|NCT00734695|"~     Eye burns may cause a severe permanent damage. One kind of treatment is the use of vitamin C~     (Ascorbic acid). This study will compare between subconjunctival topical and/or systemic~     route of administration and topical and/or systemic administration.~   "
215814|NCT00734682|"~     This is a Phase I study of Nanoliposomal CPT-11 in patients with Recurrent high-grade~     gliomas. Patients must have a histologically proven intracranial malignant glioma, which~     includes glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA),~     anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant~     astrocytoma NOS (not otherwise specified). Patients who are wild type or heterozygous for the~     UGT1A1*28 gene will received Nanoliposomal CPT-11. The total anticipated accrual will be~     approximately 36 patients (depending upon the actual MTD). The investigators hypothesis is~     that this new formulation of CPT-11 will increase survival over that seen in historical~     controls who have recurrent gliomas because CPT-11 will be encapsulated in a liposome~     nanoparticle, which has been seen to reduce toxicities from the drug.~   "
215815|NCT00734669|"~     The aim of this study is to establish the risk and frequency of non-symptomatic hypoglycemia~     in type 2 diabetes under previous therapy with glibenclamide. Participants will be monitored~     via a continuous glucose monitoring system in a standardized clinical setting during day and~     night time, implementing meals and exercise of moderate intensity performed in the~     postprandial state.~   "
215816|NCT00734656|"~     This study will explore the hypothesis that effects of alcohol are in part mediated by~     increased production of neuroactive steroids, which interact with GABAA-receptors. We propose~     to study non-dependent drinkers using a 4-session within-subjects design in which alcohol /~     placebo is paired with dutasteride / placebo pretreatment. Dutasteride is a 5-alpha steroid~     reductase (5AR) inhibitor that limits the production of dihydrotestosterone and the~     5a-reduced neuroactive steroids allopregnanolone, pregnanolone and 3a,5a-androstanediol.~   "
215817|NCT00734643|"~     Survival for one of the most complex forms of congenital heart disease, hypoplastic left~     heart syndrome (HLHS), has improved dramatically. However, little is known about family~     stress, coping and outcomes following the diagnosis of HLHS. It is expected that families~     face emotional, social and financial stressors. Health care professionals have a unique~     opportunity to positively influence how families interpret and adapt to these stressors. The~     specific aims of the study are to describe perceived stress, and coping skills utilized, in~     parents of children with HLHS and their impact on family outcomes measured as well-being,~     adaptation and caregiver/family quality of life, and to describe changes in stress, coping,~     and adaptation and differences in perceptions of mothers versus fathers of children with HLHS~     over the first 14 months of life. The Resiliency Model of Family Adjustment and Adaptation~     (McCubbin, Thompson, & McCubbin, 1996) is the theoretical framework that guides this~     research.~      Hypotheses:~        1. Family perception of stress, and coping skills utilized, will have an impact on family~          outcomes measured as well-being, adaptation, and caregiver/family quality of life.~        2. Variables influencing perception of stress and variables influencing family coping will~          be significant predictors of family adaptation outcomes.~        3. Perceptions of stress, coping skills utilized, and family adaptation outcomes will~          improve during the first 14 months of life with an infant with HLHS.~        4. Mothers and fathers will report different perceptions of stress, coping skills utilized,~          and family adaptation outcomes during the first 14 months of life with an infant with~          HLHS.~   "
215818|NCT00734630|"~     This study will assess blood pressure reduction with nebivolol or placebo in patients taking~     lisinopril or losartan.~   "
215848|NCT00734240|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     doses of ISIS 353512, to evaluate the blood concentration and rate elimination of ISIS 353512~     from the blood, and to evaluate the effectiveness of ISIS 353512 in lowering a protein in the~     blood associated with inflammation.~   "
216314|NCT00728091|"~     The primary objective of this study is to assess the efficacy of satavaptan versus placebo in~     participants with dilutional hyponatremia due to SIADH.~      Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and~     the clinical benefit in these participants.~   "
215819|NCT00734617|"~     The main goals of the study are to assess benefits of higher doses of the nicotine patch~     prior to smoking cessation for high- and low-dependent smokers, and to investigate the~     potential relationship between genetic factors and smoking cessation success. There will be a~     two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240~     high-dependent & 240 low-dependent smokers; half of each group will wear two 21mg nicotine~     patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo~     patch daily, resulting in the following four conditions (120 subjects each) during the 2-week~     pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More~     Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will~     continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no~     longer be double-blind as only nicotine patches will be used: all subjects will wear one~     21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg~     patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites:~     Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have~     7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3~     weeks, 6 weeks and 10 weeks after the quit-smoking date.~   "
215820|NCT00734604|"~     The primary purpose of the study is to help answer whether tadalafil taken once a day can~     help improve the psychological outcomes (such as sexual self confidence, spontaneity and time~     concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).~   "
215821|NCT00734591|"~     In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who~     were taking Exubera than in people who were taking other diabetes medicines. All subjects~     diagnosed with lung cancer had a history of smoking and the number of lung cancer cases~     observed fell within the expected range based on population-based data. There is currently~     not enough information to determine if any of the observed lung cancer cases were related to~     Exubera use, therefore, the study is being conducted to further investigate whether Exubera~     use makes the appearance of lung cancer more likely.~   "
215822|NCT00734578|"~     The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with~     ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years~     with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.~   "
215823|NCT00734565|"~     This study will investigate safety and reactogenicity of a monovalent conjugated vaccine~     against Haemophilus influenzae type b in healthy children~   "
215824|NCT00734552|"~     This randomized, open-label, prospective study will evaluate the renal effective effect of~     compound α-Keto Acid plus low protein diet in PD Patients.~   "
215825|NCT00734539|"~     The most common etiology of infection-related death or neurodevelopmental impairment in~     neonates with birthweight <750 g is invasive candidiasis. Over 70% of the premature neonates~     who develop invasive candidiasis will die or suffer severe, permanent neurologic impairment.~     Fluconazole has been commonly used off-label in the neonatal intensive care unit, but~     definitive recommendations for its use in the nursery have been hampered by the limited~     number of well-designed trials. In neonates weighing <750 g, appropriate dosing is not known,~     definitive safety and long-term follow up trials have not been completed, and there have not~     been well-powered trials conducted to establish the efficacy of the product using mortality~     as part of the primary endpoint. Three recent proof-of-concept studies suggest that~     fluconazole will be safe and effective, and a recently completed pharmacokinetic study is~     providing data to give preliminary dosing guidance. The next logical step in drug development~     is proposed by this research: to conduct a pivotal trial to determine the safety and efficacy~     of fluconazole in premature neonates with 2-year neurodevelopmental follow-up assessment.~      362 neonates, with a birthweight <750g, were randomized at 33 US centers, to twice weekly~     fluconazole (6 mg/kg) or placebo for the first 6 weeks of life. The primary efficacy endpoint~     will be Candida-free survival at study day 49. The research will establish definitive dosing,~     safety, and efficacy of fluconazole; it will also provide critical information on the effects~     of fluconazole on neurodevelopmental impairment and antifungal resistance.~      Potential Impact:~      Approximately 17,000 neonates are born <750 grams each year in the United States. Over 5000~     will die or develop invasive Candida infections. Demonstrating safety and efficacy of~     fluconazole in preterm neonates will improve the survivability and long term outcomes for~     these neonates.~   "
215826|NCT00734526|"~     The goal of this clinical research study is to find the highest tolerable dose of sorafenib~     that can be given in combination with temozolomide. The safety of this combination will also~     be studied.~   "
215827|NCT00734513|"~     The long-range goal of this research is to develop better ways of helping GI cancer patients~     and their caregivers cope more effectively with the demands of the disease. The study is~     designed to test the hypothesis that a partner-assisted emotional disclosure intervention~     will be more effective in enhancing patient' psychological adjustment than a cancer education~     condition.~   "
215828|NCT00734500|"~     This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in~     infants and toddlers less than 24 months of age with suspected serious infection. There will~     be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive~     anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24~     hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling~     scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those~     observed in older children and adults.~   "
215829|NCT00734487|"~     The purpose of this study is to identify whether changes in age-related macular degeneration~     (AMD) over time as seen with spectral domain optical coherence tomography (SDOCT) imaging,~     can be used to predict vision loss and the advancement of AMD in people at moderate to high~     risk for progression.~   "
215830|NCT00734474|"~     This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects~     of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring~     glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type~     2 diabetes mellitus on Metformin.~   "
215831|NCT00734461|"~     This is a single-center, randomized, 7-way crossover, double-blind, active and~     placebo-controlled study to evaluate the subjective effects of oxycodone combined with~     ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent~     subjects with a history of opioid abuse. Approximately 14 subjects will be randomized to one~     of fourteen sequences selected from a balanced 7x7 Latin square design and its mirror image.~   "
215849|NCT00734227|"~     In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare~     the effectiveness in control of bleeding, mortality rate, duration of life, quality of life,~     and economic costs of two widely used treatment measures: (1) emergency transjugular~     intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.~   "
232576|NCT00511927|"~     Aim of this study is to define the possible detrimental effect of a lack of growth hormone,~     on the well-being and life expectation of patients affected by heart failure.~   "
215834|NCT00734422|"~     Procedurally Virtual reality exposure therapy (VRET) is quite similar to models of extinction~     of conditioned fears. Recent advances in animal research have identified pharmacological~     agents that appear to both accelerate and consolidate extinction learning. One of these~     cognitive enhancers is Yohimbine. An interesting finding in animal literature is that the~     administration of Yohimbine during extinction trials accelerates fear reduction and may~     convert ineffective exposures in to successful ones. It is thought that the mechanism of~     enhanced emotional memory is through elevated norepinephrine in the prefrontal cortex.~     Therefore, we propose to extend these studies by combining VRET with Yohimbine. In this pilot~     study with a between groups design 20 participants with a fear of flying will be treated with~     VRET plus Yohimbine or VRET plus placebo. This between groups design was chosen to further~     characterize the differential within and between trial extinction. Outcome will be measured~     by self-report, behavioral, and psychophysiological assessments at pre- and post-treatment.~     In addition, we will examine extinction parameters during exposures.~   "
215835|NCT00734409|"~     The purpose of this study is to determine if the use of a device called the BIS monitor in~     addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's~     level of sedation.~   "
215836|NCT00734396|"~     The purpose of the study is to test the safety and feasibility of autologous mesenchymal stem~     cell therapy in HLA-DR mismatched patients with subclinical rejection and or an increase in~     IF?TA in the renal biopsy 4 weeks or 6 months after renal transplantation.~   "
215837|NCT00734383|"~     The purpose of this study is to determine if an intravenous anesthetic with antioxidant~     properties will protect the heart of diabetic patients from injury while undergoing coronary~     bypass surgery.~   "
215838|NCT00734370|"~     Virtual Reality Exposure Therapy (VRET) is an effective treatment for anxiety disorders,~     particularly for specific phobias as fear of heights and fear of flying (e.g. Powers &~     Emmelkamp, 2008). Recent technological advances (e.g. more realistic avatars) make research~     into the efficacy of VRET for participants with elevated agoraphobic symptoms desirable.~     Therefore, the aim of the present research proposal is to investigate the comparative~     efficacy of:~        1. enhanced VRET making use of the latest avatar technology with~        2. exposure in vivo in agoraphobic participants~        3. wait-list control.~   "
215839|NCT00734357|"~     The purpose of this study is to determine if one CT contrast agent (medication injected into~     a vein; used in CT examinations to help produce clearer images) is safer to use than another.~     This study will compare the safety of two widely-used, U.S. FDA approved contrast agents,~     Isovue and Omnipaque. The investigators hypothesize that there is no significant difference~     in the rates of contrast-induced nephrotoxicity (CIN) between these agents when the overall~     population consists of low-risk patients.~   "
215840|NCT00734344|"~     This is a single-site, investigator-initiated, open-label, randomized/controlled clinical~     trial to compare the viral load response in plasma (and, in a subset of subjects, in~     gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection~     treated with 12 weeks of raltegravir-based versus efavirenz-based ART (each combined with~     tenofovir/emtricitabine). Subjects will receive a self-limited course of therapy rather than~     a commitment to life-long HAART, as has been the experimental approach in a variety of~     clinical protocols in the United States and Europe. Subjects will complete a 12 week course~     of therapy, and those who meet treatment-response and safety criteria will then undergo a~     similarly intensive period of virology and immunology monitoring to compare the timing and~     dynamics of any observed virologic rebound following the treatment intervention.~   "
215841|NCT00734331|"~     There is a reciprocal relationship between the central nervous system and the immune system.~     Stimulation of the vagus nerve results in secretion of acetylcholine (Ach) which decreases~     secretion of pro-inflammatory cytokines. Acetylcholine esterase is an enzyme that neutralizes~     Ach and thus, involves in regulation of Ach levels, and in the cholinergic tone and~     inflammatory state.~      MicroRNAs (miRs) are evolutionarily conserved, RNAs that regulate gene expression. The~     investigators hypothesized that miRs controlling systemic communication processes function in~     one tissue in response to signals (i.e. neuronal, hormonal or others) from another.~      Specifically, the investigators hypothesized that miRs control the inflammatory response in~     inflammatory bowel diseases through regulation of expression of messenger RNA of AchE.~   "
215842|NCT00734318|"~     The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the~     treatment of severe persisent asthma in adult subjects.~   "
215843|NCT00734305|"~     This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3~     design to determine maximum tolerated dose/recommended Phase 2 dose.~   "
215844|NCT00734292|"~     The primary purpose of this study is to evaluate the early bronchodilating effect of SKP~     FlutiForm HFA pMDI compared to placebo.~   "
215845|NCT00734279|"~     The purpose of this study is to determine if the timing of the onset of puberty may be~     affected by FSH-regulatory peptides.~      We will determine how these peptides relate to FSH production in prepubertal and pubertal~     children by comparing the regulation of FSH control in children with precocious (early)~     puberty and delayed puberty.~      In this pilot study, we will stimulate the pubertal axis using an agonist of GnRH to~     determine the pubertal response of activin-A, inhibin-A and -B and follistatin.~      To determine baseline FSH secretion and FSH-regulatory peptide tone, we will block GnRH with~     a specific antagonist.~      These studies should lead to a better understanding of the role of FSH in controlling the~     onset of puberty and the pathogenesis of pubertal disorders.~   "
215846|NCT00734266|"~     The hypotheses of this study are that:~        -  Production and release of inflammatory substances called leukotrienes are increased~          during heart surgery with use of a heart-lung machine in humans;~        -  The increase in these leukotrienes levels after heart surgery is higher in patients with~          bronchitis and/or emphysema than in patients without previous history of lung disease;~        -  Levels of leukotrienes are directly correlated with worsening of lung function during~          and after heart surgery.~   "
215847|NCT00734253|"~     The primary objective of this study is to evaluate the efficacy of two different doses of~     Pyridorin (150 mg and 300 mg)compared to placebo in retarding the progression of diabetic~     nephropathy. This will be assessed by measuring the change in serum creatinine and other~     biomarkers of kidney disease during the course of the 1-year study.~   "
215850|NCT00734214|"~     Children who are undergoing surgery need intravenous fluids to prevent dehydration and~     maintain their electrolyte balance. The current standard of care in these children is to use~     a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been~     tested. There is ongoing concern from the medical community that this type of fluid increases~     the child's risk of developing low sodium levels, and hence may not be safe for all children.~     Low sodium can lead to significant complications such as seizures, coma and even death, risks~     of which are often underestimated and not anticipated by their caregivers. Experts in the~     field suggest that giving a solution with a similar sodium content to that of blood (isotonic~     fluid) reduces the risk of these problems in these children. This study will compare these~     two types of intravenous fluids (hypotonic versus isotonic), in a blinded fashion (i.e.~     neither the patient nor caregivers or investigators will be aware which type of fluid the~     patient is receiving), in children following surgery. The investigators goal is to see which~     type of fluid is safer, and leads to more stable sodium levels. This would in turn lead to a~     lower risk of complications as described above.~      This is the first time such a study is preformed in pediatrics. There are unnecessary number~     of complications and potential deaths from this disorder, and hence the safety of everyday~     fluid practice in children needs to be scientifically tested. The results of this study will~     enable the investigators to propose scientifically based guidelines on how to minimize risks~     associated with intravenous infusions in children.~   "
215851|NCT00734201|"~     Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo~     to study the effect of V24343 on blood pressure and weight in obese subjects.~      The primary variables, change in blood pressure (BP) and pulse, will be assessed both by~     outpatient ambulatory monitoring of vital signs and by regular clinic monitoring.~      The efficacy of V24343 will be assessed by measurement of body weight, waist circumference,~     bioimpedance assessment of body composition and blood glucose.~      Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing~     will be used to assess the pharmacokinetics of V24343.~      Other safety assessments comprise routine monitoring of adverse events; concomitant~     medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and~     self-completed psychiatric assessments.~   "
215852|NCT00734188|"~     This is an open-label, dose-escalation study to determine the safety, maximum tolerated dose~     (MTD) and dose-limiting toxicities (DLT) of 188Re-PTI-6D2 in patients with metastatic~     melanoma.~   "
215853|NCT00734175|"~     In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were~     associated with significant morbidity and mortality. It is estimated that, in the United~     States alone, the next influenza pandemic could cause approximately 200,000 deaths and~     750,000 hospitalizations. Thus, the development of a vaccine against potential influenza~     strains has become a priority. The purpose of this study is to determine the safety and~     immune response to an H6N1 influenza vaccine candidate.~   "
215854|NCT00734162|"~     The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability~     of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic~     hepatitis B virus (HBV) infection.~      The optimal treatment for adolescents with chronic HBV infection is currently unknown.~     Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations~     has been shown to be less than optimal. Further, the safety and efficacy of entecavir and~     telbivudine have not been established in patients < 16 years of age. A study evaluating TDF~     in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in the~     treatment of chronic hepatitis B in this patient population. In addition, the study will help~     to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through their~     participation, study participants will help generate critical new information to help guide~     the most optimal treatment of chronic HBV infection in adolescents.~      This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and~     tolerability of TDF versus placebo in adolescents with chronic HBV infection. TDF~     treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72 weeks~     of blinded treatment, participants were to switch to open-label TDF for an additional 2.5~     years of treatment, provided that no safety concerns are identified by the Independent Data~     Monitoring Committee monitoring the study.~   "
215855|NCT00734149|"~     The purpose of this study is to assess the efficacy of bortezomib in combination with~     melphalan and prednisone to achieve complete responses for patients with previously untreated~     multiple myeloma compared to an historical control group. This trial will also evaluate the~     safety and toxicity of this regimen as well as evaluate the duration of response of this~     regimen.~   "
215856|NCT00734136|"~     This Study will look at the effect of substances called angiogenic factors(development of~     new blood vessels) have on the development of severe liver disease. The results may help to~     understand the factors involved in the repair and regeneration of liver tissue and to see if~     different types of liver disease are associated with different types of factors, especially~     in the severe liver disease called hepatorenal syndrome.~   "
215857|NCT00734123|"~     The incidence of cardiovascular diseases is still high and further efforts should be done in~     primary prevention. The main objective is to quantify the burden of subclinical~     atherosclerosis using non-invasive techniques,and to study the impact of this assessment and~     consequent treatment in the progression of atherosclerosis and in the incidence of~     cardiovascular diseases.~   "
215858|NCT00734110|"~     The main purpose of this study is to record information from clinical and radiographic~     examinations and patient assessment questionnaires before surgery and at suitable~     postoperative intervals to assess the functioning and symptomology of each knee following~     surgery.~      In addition, any adverse events or complications are to be recorded, and any device failures~     or early revisions are to be recorded and reported directly to the Sponsor. The data are to~     be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum~     of 5 years.~   "
215859|NCT00734097|"~     The purpose of this study is to assess how patients with gastro-oesophageal reflux disease~     (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still~     experiencing symptoms will benefit from a change in treatment.~   "
215902|NCT00733538|"~     -  Assessment of survival without progression of stage I MM in two groups: arm A: simple~          survey and arm B: administration of Zoledronate.~        -  Describe different progression's type noticed and define the prognosis factors of a fast~          evolution.~   "
215860|NCT00734084|"~     The primary purpose of this investigation is to evaluate the surgical performance of the~     DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a~     Multi-centre setting.~      The secondary objective of this investigation is to evaluate the long-term survivorship of~     the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.~   "
215861|NCT00734071|"~     The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily~     (QD), in treating Generalized Anxiety Disorder.~   "
215862|NCT00734058|"~     The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System~     and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of~     atrial fibrillation.~      The study will test the safety and effectiveness of the EndoPhotonix™ Laser Ablation Systems~     to photocoagulate cardiac tissue during cardiac surgery, to create electrical isolation of~     the pulmonary veins and create other electrical isolation lesions in order to treat atrial~     fibrillation. The surgical procedure will be conducted during concomitant mitral valve repair~     or replacement surgery or in combination with other cardiac surgery including aortic valve~     surgery, tricuspid valve surgery, or coronary artery bypass surgery.~   "
215863|NCT00734045|"~     The primary objective of the study is to establish the correlation between NT-proBNP~     measurements in fresh human whole blood samples and those in plasma samples from the same~     study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and~     measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in~     a laboratory setting.~   "
215864|NCT00734032|"~     The primary objective of this study is to examine the effects of SB-480848 on plasma~     lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a~     4-week treatment with SB-480848.~   "
215865|NCT00734019|"~     The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a~     cobalt chrome tibial tray at 5 years.~   "
215866|NCT00734006|"~     The aim of the proposed research is to measure the effect of drug-induced sedation on the~     functional connectivity between brain regions as indicated by EEG signal transmission within~     the human brain. The results of this study will help to identify the neurophysiological~     correlates of changes in conscious experience that occur during drug-induced sedation.~   "
215867|NCT00733993|"~     This study is being done to find out if medicines that affect a neurotransmitter (chemical~     messenger) in the brain called adenosine improve behavioral problems that are related to drug~     abuse. Another purpose of the study is to find out how genes related to adenosine change how~     people respond to these medicines. More information about how these medicines change~     behaviors may be helpful to come up with new treatments for drug abuse.~   "
215868|NCT00733980|"~     This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared~     to placebo in female subjects with major depressive disorder~   "
215869|NCT00733967|"~     The primary aim of the study is to determine the safety and tolerability of treatment with~     Varenicline in methamphetamine-dependent volunteers. The investigators also seek to determine~     the effects of treatment with Varenicline, as compared to placebo, on craving for~     methamphetamine or cigarettes following exposure to methamphetamine and smoking cues,~     respectively. The effects of treatment with Varenicline, as compared to placebo, on~     subjective effects produced by administration of methamphetamine or placebo will be attempted~     to be determined. Lastly, the investigators hope to determine the effects of treatment with~     Varenicline, as compared to placebo, on reinforcing effects produced by administration of~     methamphetamine or placebo.~   "
215870|NCT00733954|"~     This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate~     Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in~     Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one~     of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate~     ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.~   "
215871|NCT00733941|"~     Individuals who participate in regular physical exercise possess a lower prevalence of~     cardiovascular risk factors such as hypertension, type 2 diabetes, obesity and~     hypercholesterolemia, and aerobic exercise is therefore considered an important adjuvant~     therapy in risk factor modification and to promote health.~      The main focus of the present study is therefore to detect how rapid it is possible to~     increase aerobic capacity with interval running exercise.~      The hypothesis is that it is possible to improve maximal oxygen uptake faster when increasing~     training frequency. The total gain in maximal oxygen uptake will however be the same between~     the two groups when they have performed the same amount of training~   "
215872|NCT00733928|"~     The primary objective of this investigation was to evaluate & compare the performance of the~     P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using~     RSA.~      The secondary objectives of this investigation are to evaluate the clinical and patient~     outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining~     all-polyethylene and metal-backed tibia components.~   "
215873|NCT00733915|"~     The main objective of this study is to evaluate how the LCS Complete mobile-bearing total~     knee system and surgical instrumentation performs.~   "
215874|NCT00733902|"~     Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.~   "
215875|NCT00733889|"~     The purpose of the study is to determine efficacy ans safety of the combination of cetuximab~     and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant therapy followed~     concomitant chemoradiotherapy (cisplatin) plus cetuximab in patients with a locoregional~     esophageal carcinoma~   "
215876|NCT00733876|"~     The purpose of this trial is to determine if the administration of allogeneic MSCs at defined~     doses is safe in patients who are at high risk of developing significant Acute Kidney Injury~     (AKI) after undergoing on-pump cardiac surgery.~   "
215877|NCT00733863|"~     This study will evaluate the safety and tolerability of repeated subcutaneous injections of~     CAD106 in patients with mild Alzheimer's disease.~   "
215903|NCT00733525|"~     This study will compare the medical and cost effectiveness of a stepped approach, including~     self-help and drug therapies, to the current best available care for bulimia nervosa.~   "
215904|NCT00733512|"~     To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons~     throughout the United States.~   "
215878|NCT00733850|"~     Gemcitabine is usually used to treat cancer of the pancreas. The purpose of this study is to~     determine if Kanglaite Injection (KLT) is safe in patients with cancer of the pancreas, and~     whether it improves the effectiveness of gemcitabine. Additionally, the effect, if any, of~     KLT on the signs and symptoms of cancer as well as the common side effects of chemotherapy~     will be evaluated.~      The research drug, KLT, is purified from a traditional Chinese medicine called coix seed. It~     is approved in China for use in combination with chemotherapy to treat patients with advanced~     lung cancer and liver cancer. It is also approved in China for use by itself to treat the~     symptoms of cancer in patients with advanced cancer of any kind. In the US, KLT is purely~     experimental and is not approved for any use. While a small number of cancer patients in the~     US have received KLT alone in a Phase I study, this is the first US protocol to evaluate~     whether or not KLT is useful in pancreatic cancer.~      This phase II clinical study was completed in the US in June 2014. The clinical study report~     was submitted to the FDA in January 2015. The designs of the phase III clinical study for KLT~     has been cleared by the FDA in May 2015 and will be launched soon.~   "
215879|NCT00733837|"~     The purpose of this study is to determine the relationship between cervical multifidi~     thickness, cervical spine proprioception and possible reflex activation of cervical multifidi~     through stimulation of joint mechanoreceptors. Cervical mechanoreceptors will be activated~     with an innocuous, nonspecific stimulation. Participants will have cervical spine~     proprioception assessed through joint position sense testing. The multifidus muscle thickness~     and activation state is to be assessed by sonography. These measures are done pre & post to~     the innocuous stimulation. There is no specific hypothesis.~   "
215880|NCT00733824|"~     This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard~     G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for~     lymphoma.~      The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a~     significantly higher proportion of lymphoma patients will collect ≥ 2 x 10E6 CD34+ cells/kg.~   "
215881|NCT00733811|"~     Changes in chelation treatment and transfusion practices, during the past two decades, have~     dramatically improved the prognosis of thalassemia major patients.Deferiprone (DFP) has been~     compared with deferoxamine (DFO), using different schedules of treatment, in the majority of~     the 13 clinical trials published between 1990 and 2008.No statistically significant~     difference was shown between these two interventions during, at most, 18 months of~     treatment.Three randomised trials that compared sequential DFP-DFO treatment versus DFO alone~     reported controversial results but this could be due to small sample sizes and short~     treatment duration. In fact, no trial with treatment duration longer than 18 months15, which~     reported on mortality, adverse events, serum ferritin concentrations, as well as costs has so~     far been published.~      This long-term sequential DFP-DFO treatment versus DFP alone treatment trial was conducted to~     assess the impacts of these chelation treatments on serum ferritin concentrations, mortality,~     adverse events, and costs in thalassemia major patients.~   "
215882|NCT00733798|"~     The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the~     treatment of adult patients with progressive and/or recurrent malignant melanoma.~   "
215883|NCT00733785|"~     The present pharmacokinetic study is designed to further characterise the pharmacokinetics of~     the RSG XR formulation and aims to assess dose proportionality, strength equivalence, the~     food effect and the pharmacokinetics after repeat dosing.~   "
215884|NCT00733772|"~     The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is~     effective in the treatment of metabolic syndrome (MetS).~   "
215885|NCT00733759|"~     Pulmonary arteriovenous malformations (PAVMs) are thin-walled abnormal vessels which provide~     direct capillary-free communications between the pulmonary and systemic circulations.~     Patients with PAVMs have usually have low blood oxygen levels and are at risk of other~     complications including strokes, brain abscesses, pregnancy-related complications and~     haemorrhage. We hypothesise that the complications of PAVM patients arise from their PAVMs~     and not the more recognised intracardiac forms of shunting. We propose to perform~     echocardiograms to enable assessment of the presence of other causes of capillary-free~     communications between the pulmonary and systemic circulations.~   "
215886|NCT00733746|"~     PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given~     before and after surgery in treating patients with pancreatic cancer that can be removed by~     surgery. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed. Giving these drugs after surgery may~     kill any tumor cells that remain after surgery.~   "
215887|NCT00733733|"~     One of the greatest problems in renal transplantation is the shortage of donor kidneys.~     Kidneys of non-heart-beating donors (NHB) are a possible solution, but transplantation is~     accompanied with a high percentage of acute renal failure, caused by ischemia-reperfusion~     injury. The increased ischemia-reperfusion injury results in an increased immune activation,~     which can lead to more injury of the kidney and additional acute rejections. The hypothesis~     of this trial is that ischemia-reperfusion injury can be diminished by ATG. ATG could have~     additional favourable effects. To investigate this half of the patients is treated with~     additional ATG to the standard immunosuppressive treatment. Calcineurin inhibitors are not~     diminished during the first days after transplantation to investigate whether ATG has special~     effects on ischemia-reperfusion injury.~   "
215888|NCT00733720|"~     The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg,~     8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral~     naltrexone. This study will provide data to support the design of a similar study of the~     depot formulation of naltrexone and ultimately to study this combination for the treatment of~     cocaine dependence.~   "
215905|NCT00733499|"~     The primary objective of this investigation is to test the hypothesis that the Duofix Tibial~     component results in a reduction of immediate postoperative pain compared to the LCS Porocoat~     version.~   "
216315|NCT00728078|"~     The purpose of the investigators' study is to prospectively evaluate whether low-dose~     thalidomide adjuvant therapy will improve the outcome of radiofrequency ablation for~     hepatocellular carcinoma (HCC).~   "
215889|NCT00733707|"~     The purpose of this study is to determine whether there is increased oral contraceptive pill~     (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared~     to women who do not receive reminders. The investigators hypothesize that women who receive~     daily text messaging reminders to take their OCP will have increased pill adherence compared~     to women who do not receive reminders.~      The investigators also hope to determine whether there is a difference in OCP adherence as~     measured by electronic monitoring device and wireless real-time data collection versus~     traditional patient pill diaries. The investigators hypothesize that electronic monitoring~     device and wireless real-time data collection will demonstrate lower adherence compared to~     traditional patient pill diaries.~   "
215890|NCT00733694|"~     To determine how the LCS mobile bearing knee system works within the Asian Population.~   "
215891|NCT00733681|"~     The purpose of this study is to evaluate the long-term clinical and functional performance of~     the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine~     whether the implant design results in a longer-lasting knee replacement.~   "
215892|NCT00733668|"~     An open-label, non-comparative, multi-centre, phase II prospective trial to assess the~     efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors~     (SSRIs) in SSRI-resistant major depressive disorder.~   "
215893|NCT00733655|"~     Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an~     disease that leads to the development of dilated and fragile blood vessels. We propose to~     obtain small skin samples from patients with HHT in order to analyze the samples using~     histological methods, and study the properties of vascular endothelial cells derived from~     patients. We hypothesize that these cells will show altered growth, migration, and protein~     synthetic differences when compared to normal endothelial cells, which may be confirmed in~     single time point analyses in histological samples. We anticipate that that these findings~     may help to explain aspects of the HHT disease phenotype.~   "
215894|NCT00733642|"~     The purpose of this study is to determine whether single doses of PF-04360365 is safe and~     well tolerated in patients with Alzheimer's Disease.~   "
215895|NCT00733629|"~     Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an~     disease that leads to the development of dilated and fragile blood vessels. We propose to~     culture endothelial cells from patients with HHT, to culture cells that express the proteins~     mutated in HHT, namely endoglin and ALK-1. We will study the properties of these cells which~     will involve their growth in different conditions and anticipate that DNA, mRNA and proteins~     will be extracted from these cells for study of cell responses and association with~     expression levels of endoglin and ALK-1. We hypothesize that these cells which express~     half-normal endoglin or ALK-1 will show altered protein synthetic differences when compared~     to normal white blood cells. We anticipate that that these findings may help to explain~     aspects of the HHT disease phenotype.~   "
215896|NCT00733616|"~     The purpose of the study is to determine efficacy and safety of combination therapy with~     adjusted-dose docetaxel-oxaliplatin-capecitabine in patients with advanced gastric~     adenocarcinoma and intermediate general status.(defined as ECOG 2 or weight loss 10-25% or~     older that 70 years and no comorbidities nor functional dependency nor geriatric syndrome)~   "
215897|NCT00733603|"~     There are many different treatments that doctors recommend for patients with IC/PBS. Only a~     few research studies have been done to evaluate treatments given to patients. Treatment~     choices can be of two types: drug therapy and non-drug therapy. The two treatments used in~     this study will be of the non-drug therapy type. One of the treatments being used in this~     study is called Myofascial Tissue Manipulation. This is a kind of physical therapy that is~     designed to work on specific muscles and tissue layers in a particular part of the body. In~     this study, this treatment will focus on the areas around the pelvis and the pelvic floor.~     The treatment will involve the physical therapist's use of hands and fingers to target~     specific muscles and tissues located within your pelvis, rectum, and/or vagina (the pelvic~     floor) as well as muscles and layers of tissue in your abdomen and legs. The other treatment~     being used in this study is Global Therapeutic Massage. This treatment involves the physical~     therapist's use of classic Western body massage techniques on the muscles of your arms, legs,~     hands, neck, shoulders, back, stomach, buttocks, and feet to create an overall feeling of~     well being.~      The purpose of this research study is to find out if Pelvic Physical Therapy is safe and~     effective on treating symptoms in women with interstitial cystitis as compared to a full body~     therapeutic massage. This study will also measure the lasting effects of the treatment up to~     3 months after your last study treatment.~   "
215898|NCT00733590|"~     The overall hypothesis of this study is that subtle interactions between structural~     (substrate) and functional (trigger) abnormalities of the heart, some of which are~     genetically-determined, can be used to identify patients at high risk of sudden cardiac death~     (SCD). Such information may be used to better define patients most likely to benefit from~     replacement of an internal defibrillator (ICD). The prospective, observational study to~     enroll, categorize and follow patients who receive an ICD pulse generator replacement for~     primary prevention of SCD (PROSe-ICD) was established to :~        1. to gain a better understanding of the biological mechanisms that predispose to SCD~        2. to develop readily determined clinical, electrocardiographic, genetic and blood protein~          markers identify patients with an increased risk of dying suddenly~   "
215899|NCT00733577|"~     This is an escalating dose study in subjects with T2DM, which will consist of four~     overlapping cohorts receiving 6 days of SB756050 to assess safety, pharmacokinetics, and~     pharmacodynamics.~   "
215900|NCT00733564|"~     Anesthesia during uterine curettage is a problem. Paracervical block is used in general for~     such an operation, though, the anesthetic efficacy is incomplete. Propofol is the~     short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new~     inhalational anesthetic well-known for it's easy come, easy go property. The investigators~     hypothesized that propofol, sevoflurane and paracervical block had different anesthetic~     efficacy during uterine curettage. Which one is the optimal selection for such operation~     needed to be evaluated.~   "
215901|NCT00733551|"~     This study will evaluate the safety, tolerability and exposure of repeat escalating oral~     doses of GSK962040.~   "
216467|NCT00726037|"~     This study is designed to determine the duration of T reg suppression in patients with~     metastatic pancreatic cancer receiving Ontak. The goal is to define the optimal time for~     future dendritic cell vaccine administration.~   "
215906|NCT00733486|"~     The primary objective of this investigation is to determine the survivorship of the LCS~     Complete AP Glide mobile bearing knee prosthesis at 5 years.~      The secondary objectives of this investigation are to evaluate the clinical performance of~     the LCS® Complete AP Glide mobile bearing knee prosthesis and to determine its long-term~     survivorship.~   "
215907|NCT00733473|"~     The purpose of this study is to determine if adding nebulized budesonide to the systemic~     steroid for treatment of acute wheezing has any additive benefit in children who have~     hospitalized for acute wheezing.~   "
215908|NCT00733460|"~     Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery~     Disease (CAD) patients , male or female and of age ranging between 20-80 years old.~   "
215909|NCT00733447|"~     The purposes of this study are to confirm that the Freedom Driver System is a suitable~     pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers~     can be trained to manage the Freedom Driver System safely outside the hospital.~   "
215910|NCT00733434|"~     Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so~     it is used by some surgeons after microsurgery to keep the patency of the anastomosed small~     vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep~     vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 after head~     and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases~     postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a~     comparable complication rate as the control group.~   "
215911|NCT00733421|"~     The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase~     inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of~     debate since long.~      There is, however, limited data in humans and further prospective randomised studies are~     warranted. Ekman et al studied in a prospective randomised double blind study the effects of~     celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery.~     They found significant effects on reduction of pain and need for opioid analgesics~     postoperatively but could see no negative effects the numbers of none-unions at a 1-year~     follow up 3.~      In a similar prospective randomised double-blind study design significant effects in~     reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the~     perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative~     effects could bee seen on six month follow-up of the strength of the reconstructed ligament.~      The aim of the present study is to further study the effects of the perioperative use of~     etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective randomised double-blind~     study on bone healing, pain and need for rescue analgesia in patients undergoing elective~     Hallux Valgus surgery with a standardised surgical technique including an osteotomy of~     metatarsale I and excision of exostosis.~      Study population 100 American Society of Anesthesiology (ASA) physiological status1-2~     patients scheduled for elective hallux valgus (HV) surgery~      The patients are going to be randomised into 2 groups, 50 patients in each;~        1. etoricoxib 90 mg once daily x 5~        2. tramadol 100 mg twice daily x 5~      First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t.~     oxycodone 10 mg~      Primary study variables:~        -  X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a~          CT-scan modelling of the osteotomy at twelve weeks after surgery~        -  Number of patients requiring rescue medication~        -  Patient assessment using brief pain inventory 24 hours and 2 weeks after surgery~      Secondary study variables are;~        -  Visual Analogue Scale (VAS) grading Day 1-7~        -  Compliance to base medication~        -  Need for rescue analgesia Day 1-7~        -  Adverse Effects~             -  Experience of any emetic symptoms~             -  Experience of any gastrointestinal symptoms~        -  Satisfaction with pain medication Day 20~        -  Wound dressing Day 20~        -  Clinical evaluation 17 weeks, final assessment~   "
215912|NCT00733408|"~     This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle~     (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib~     hydrochloride work in treating patients with metastatic breast cancer. Drugs used in~     chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can prevent cancer growth by~     blocking the ability of cancer cells to grow and spread. Erlotinib hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial~     evaluates a maintenance treatment with erlotinib and bevacizumab after Nab-paclitaxel and~     bevacizumab which may control cancer growth with biologic therapies.~   "
215913|NCT00733395|"~     The purpose of this study is to examine how certain kinds of fruit juice that contain natural~     antioxidants and natural anti-inflammatory properties may reduce exercise-induced muscle pain~     and injury. Participants will be recruited from registered participants in the Hood To Coast~     Relay. The Hood To Coast Relay Race Officials will post the study on their website to find~     interested teams. Interested participants will then be contacted by the study staff by phone~     regarding the study's inclusion and exclusion criteria and to schedule the initial health~     screening visit. The participants will undergo an initial health screening and survey about~     muscle soreness, and then drink the investigational juice twice daily for 8 days. On the 7th~     day of drink administration, the participants will report to the starting location of the~     Hood To Coast Relay to meet with the investigators for 30 minutes to survey muscle pain and~     juice tolerability. The participants will then participate in the Hood To Coast Relay,~     drinking 2 more bottles of juice over the duration of the relay. At the conclusion of the~     relay, the participants will meet with study investigators to take the same short survey~     about muscle pain and juice tolerability.~   "
215914|NCT00733382|"~     Dexamethasone is a safe and cheap abortive therapy for migraine headache. The effect of it is~     never evaluate and not correlate with the effect of popular anti migraine medication such as~     dihydroergotamine. The investigators proposal is to compare its effect with~     dihydroergotamine.~   "
215915|NCT00733369|"~     The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a~     greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in~     primary TKA.~      The secondary objectives of this investigation are to evaluate the clinical and patient~     outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior~     Stabilised (PS) Knee over 5 years.~   "
215916|NCT00733356|"~     This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of~     Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to~     detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on~     reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be~     between the ages of 6 and 12 at the beginning of the study.~   "
215917|NCT00733343|"~     The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of~     adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart~     failure due to left ventricular systolic dysfunction, already receiving optimal medical~     therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea.~     Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control~     group is 35% in the first year. It is assumed that the hazard rate is constant over time.~   "
215918|NCT00733330|"~     The primary objective of this investigation is to compare the precision of long leg alignment~     achieved by the two types of procedure. The secondary objectives of this investigation are~     to:~      Compare the accuracy of long leg alignment achieved by the two types of procedure.~      Compare the number of optimal implantations achieved by the two types of procedure.~      Compare the clinical performance of the knee replacement in subjects who have undergone one~     of the two types of procedure.~      Compare the functional outcome achieved by subjects who have undergone one of the two types~     of procedure.~      Compare the interface radiographic appearance 5 years post-operatively between the two types~     of procedure.~      Compare the accuracy and precision of long leg alignment achieved by the two types of~     procedure 5 years post-operatively, i.e., at final follow-up and also the change in accuracy~     and precision between the final follow-up and baseline.~      Compare the Adverse Events experienced by the subjects who have undergone the two types of~     procedure.~   "
215919|NCT00733317|"~     The purpose of this study is to determine if adding nebulized budesonide to the systemic~     steroid for treatment of acute wheezing has any additive benefit in the emergency room.~   "
215920|NCT00733304|"~     This is a two month study to allow continued treatment with pazopanib eye drops. Study may be~     extended to 5 months.~   "
215921|NCT00733291|"~     The purpose of this study is to evaluate daily disposable lenses inserted out of the blister~     package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution~     FID 107027.~   "
215922|NCT00733278|"~     This is a pilot study of up to 10 women, which will test the hypothesis that the placement of~     copper IUDs through the uterine incision at the time of uncomplicated elective C-section is~     technically feasible and acceptable to women seeking long-term contraception.~   "
215923|NCT00733265|"~     The main purpose of this study is to examine how AZD6140 affects patients with severe kidney~     disease compared to volunteers with normal kidneys. Subjects in the study will receive one~     dose of AZD6140.~   "
215924|NCT00733252|"~     RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and~     diagnose lung cancer or precancerous cells.~      PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway~     works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung~     disease.~   "
215925|NCT00733239|"~     This study involves giving psychoactive drugs intramuscularly (injected into the muscle of~     the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the~     difference between one drug and another, as well as measuring the effects of the drugs on~     mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each~     subject will receive 2-4 of the listed interventions.~   "
215926|NCT00733226|"~     The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on~     respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of~     attacks and effect on serum cytokine levels.~   "
215927|NCT00733213|"~     A retrospective, registry analysis of the socio-economic and demographic characteristics of~     patients suffering from locally advanced or metastatic prostate cancer, as well as the~     depiction of the therapeutic algorithms followed in the Greek clinical practice.~        -  Target Group: Patients with locally advanced or metastatic prostate cancer.~        -  The first 10 consecutive patients records that meet the entry criteria.~   "
215928|NCT00733200|"~     The investigators conducted a prospective study to determine the safety and efficacy of minor~     and major hepatectomy selected by predetermined criteria in 138 patients with hilar~     cholangiocarcinoma. In selected patients, minor liver resection was a good treatment.~   "
215929|NCT00733187|"~     To estimate the effect of food on the oral bioavailability and effect of diurnal variation on~     the pharmacokinetics of ABT-869.~   "
215930|NCT00733174|"~     Subjects with impaired glucose tolerance will be randomized to either rosiglitazone or~     placebo for a 18 month period. The study will look at baseline, 12 month and 18 month data~     for exercise tolerance, coronary artery calcification and diabetes indicators.~   "
215931|NCT00733161|"~     The purpose of this study is to determine the effect of passive exercise on systemic~     endothelial function in elderly patients with chronic heart failure.~   "
215932|NCT00733148|"~     The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients)~     aims to develop a low-risk monitoring and control device which allows maintaining metabolic~     control in intensive care units. A system will be developed comprising three subsystems: a~     body interface for the delivery of biofluids, biosensors for the determination of glucose~     concentration in these biofluids and an adaptive control algorithm that generates advice and~     thus represents a decision support system with respect to insulin infusion rate to establish~     glycaemic control in critically ill patients. Within a closed loop system, intensified~     insulin treatment will make use of the calculations leading to external regulation of~     glucose.~      It is the aim of this study to evaluate the correlation between arterial blood glucose~     concentrations and interstitial fluid glucose concentrations in post surgery patients in the~     Intensive Care Unit (ICU). Interstitial fluid glucose concentrations are based on~     microdialysis in subcutaneous adipose tissue and calculated using the ionic reference~     technique.~   "
215933|NCT00733135|"~     This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™~     plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in~     treatment of moderate to severely calcified peripheral arterial disease in the superficial~     femoral and/or popliteal arteries.~   "
215934|NCT00733122|"~     This study is designed to determine the tolerability and immunogenicity of a 3-dose regimen~     of Gardasil administered to healthy married females between 16 and 23 years of age, in India.~   "
215935|NCT00733109|"~     The aim of this study was to compare two management options for CIN 2. This randomized~     clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as~     CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women~     subjected to follow-up at 3-month intervals for 12 months.~   "
215971|NCT00732628|"~     The purpose of this study is to evaluate the safety and effectiveness of the Boomerang~     percutaneous closure device following diagnostic cerebral angiography or neurointerventional~     procedures.~      Background:~      Very few publications have evaluated this relatively novel percutaneous closure device.~   "
215936|NCT00733096|"~     Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and~     worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2~     concluded them to be effective in the long-term. In our own double-blind, placebo-controlled~     study evaluating epidural etanercept, the results showed significant benefit in favor of the~     etanercept group, but no subject was included with a duration of pain > 9 months, and the~     results of this study have yet to be replicated.~      Currently, epidural steroid injections are the most frequently performed procedures in pain~     clinics across the U.S. However, epidural steroids may benefit only a select group of~     patients. The literature on treating sciatica is notable for a lack of randomized comparative~     studies involving various treatments. The objective of this project is to conduct a 3-arm~     study to determine the efficacy of 1) transforaminal epidural corticosteroids; and 2)~     transforaminal epidural etanercept, in patients with lumbosacral radiculopathy.~   "
215937|NCT00733083|"~     The aim of this randomized, double-blind study is to compare parenteral pre-emptive~     oxycodone, morphine and dexamethasone with placebo in the treatment of postoperative pain in~     paediatric patients 4 to 12 years of age. The investigators hope to find out whether there~     are any differences in postoperative pain and/or adverse effects among these groups.~   "
215938|NCT00733070|"~     A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™~     Guidewire for crossing chronic total occlusion in Coronary arteries.~   "
215939|NCT00733057|"~     Current antipsychotics have only a limited effect on two core symptoms of schizophrenia,~     negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline~     which has a beneficial effect in various neurological disorders. Recent findings in animal~     models and human case-reports suggest its potential for the treatment of these symptoms of~     schizophrenia. The current study aims to examine the efficacy of minocycline as add-on~     treatment for alleviating negative and cognitive symptoms in early-phase schizophrenia. The~     study will utilize a longitudinal double blind, randomized, placebo-controlled design with~     patients followed for six-months. Early-phase schizophrenia patients were recruited and~     randomly allocated to a minocycline or placebo treatment (2:1 ratio; 200 mg/day). The primary~     outcome measures are the Scale for Assessment of Negative Symptoms (SANS) and assessments of~     executive functions.~   "
215940|NCT00733044|"~     Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the~     general population. Among severe sufferers it causes disability in various areas. As a result~     of the tinnitus quality of life is often impaired. At present there is no cure or uniformly~     effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests an~     integral multidisciplinary approach in treating tinnitus is effective. The main objective of~     this study is to examine the effectiveness, costs, and cost-effectiveness of an integral~     treatment provided by a specialized tinnitus center versus usual care. This paper describes~     the study protocol.~      Methods/Design: In a randomized controlled clinical trial 198 tinnitus patients will be~     randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus~     sufferers referred to the audiological centre are eligible. Included patients will be~     followed for 12 months.~      Primary outcome measure is generic quality of life (measured with the Health Utilities Index~     Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus~     cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the~     number of patients to include is 198. Economic evaluation will be from a societal~     perspective.~      Discussion/ Conclusion: This is, to our knowledge, the first randomized controlled trial that~     evaluates an integral treatment of tinnitus that includes a full economic evaluation from a~     societal perspective. If this intervention proves to be effective and cost-effective,~     implementation of this intervention is considered and anticipated.~   "
215941|NCT00733031|"~     The primary purpose of this study is to find out what the maximum tolerated dose is for an~     experimental drug called AZD6918 based on the side effects experienced by patients with~     advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918~     will be administered twice daily. Then maximum tolerated doses in combination with either~     gemcitabine or pemetrexed will also be investigated.~   "
215942|NCT00733018|"~     Diet macronutrient relative composition, quality and quantity determines lifestyle disease,~     including cardiovascular disease, development. Our hypothesis is that a high content of~     carbohydrates in the diet contributes to increased insulin level. Moreover, activating~     enzymes promoting inflammatory processes and possibly chronic disease development in the~     body.~   "
215943|NCT00733005|"~     This study seeks to prospectively demonstrate that Nasonex is better than placebo in~     relieving nasal congestion in patients with seasonal allergic rhinitis.~   "
215944|NCT00732992|"~     This study will assess if the combination of sunitinib and pemetrexed is tolerable when~     coadministered at each recommended dose/schedule.~   "
215945|NCT00732979|"~     Intraoperative blood loss is a major concern during hepatic resection, as it has been shown~     to adversely affect patients' perioperative outcome. Reduction of central venous pressure~     during parenchymal transection has been shown to effectively lower liver hemorrhage. While~     CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair~     organ function. Moreover, it may lead to hemodynamic instability, particularly in case of~     severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping~     has been suggested which is able to lower CVP without the need for fluid restriction.~      In the present study the two strategies to reduce CVP and by this intraoperative bleeding,~     namely fluid restriction and inferior vena cava clamping are compared with intraoperative~     blood loss as primary endpoint.~   "
215946|NCT00732966|"~     Most Angiotensin receptor blocker's (ARBs) are metabolized by cytochrome P4502C9 (CYP2C9),~     one of the major isoforms of the cytochrome P450 in human liver microsome. The purpose of~     this study is to evaluate whether CYP2C9 polymorphism has a significant clinical influence on~     the blood pressure lowering effect of losartan and valsartan. Weather there is a genetic~     importance in choosing the right ARB for the right patient.~   "
215972|NCT00732615|"~     Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with~     hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D~     supplements.~   "
220770|NCT00669058|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the~     product Dermacyd Tina Gel Tangerina Mix~   "
215947|NCT00732953|"~     Percutaneous coronary intervention with stent implantation is limited on the one hand by~     restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis~     due to incomplete or not sufficient enough endothelialization of stent struts. The Genous~     stent implantation allows a rapid layer over the stent struts with endothelial progenitor~     cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis.~     Local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce~     restenosis in in-stent restenosis and de-novo lesions in vessels with small reference~     diameter. The combination of a paclitaxel-eluting balloon and Genous stent implantation may~     summarized both advantages: a rapid endothelialization limiting the number of stent~     thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing~     the risk of restenosis with the subsequent need for revascularization.~   "
215948|NCT00732940|"~     The purpose of this study is to test the safety and tolerability of repeated subcutaneous~     (SC) doses of belimumab in subjects with SLE.~   "
215949|NCT00732927|"~     Retinal vein occlusion (RVO) is the second commonest retinal disease after diabetic~     retinopathy, and is a common cause of unilateral visual loss. There are two aims in the~     management of RVO: the identification of modifiable risk factors and their medical management~     and the recognition and management of sight-threatening complications. The management of the~     disease includes laser therapy and the control of systemic associated diseases. Many other~     treatments have been proposed but there is no evidence on their efficacy in modulating the~     outcome of branch or central RVO. There are currently no adequate clinical trials that have~     evaluated the efficacy and safety of antithrombotic agents in this setting. Antiplatelet~     agents are frequently used in clinical practice. Anticoagulant drugs, either heparins or~     coumarins, are also used in this setting as they represent the first line therapy for the~     treatment of venous thromboembolism. Aim of this randomized controlled study is to to compare~     the efficacy and safety of aspirin and of a low molecular weight heparin, parnaparin, in the~     treatment of RVO. Study treatment is administered for 3 months. Primary end-point of the~     study is the incidence of functional worsening of the eye with RVO at 6 months. Secondary~     efficacy outcomes are the following: proportion of cases requiring laser treatment because of~     the extension of the ischemic lesion and/or the presence of neovascularisation and/or macular~     oedema, incidence of recurrent RVO objectively documented by fluorescein angiography. Safety~     outcomes are defined by the incidence of major and minor bleeding events.~   "
215950|NCT00732914|"~     Primary:~      To evaluate if progression-free survival from first treatment to progression or death during~     second-line therapy (total PFS) of sorafenib followed by sunitinib is superior compared to~     sunitinib followed by sorafenib.~      Secondary:~        1. Time from first treatment to progression during second-line therapy (total TTP)~        2. Time to first-line treatment failure (progression, death, discontinuation due to~          toxicity) descriptively in each arm~        3. PFS in first-line and second-line treatment, descriptively~        4. Overall survival, descriptively (data cut-off same as for primary endpoint)~        5. Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD~          according to RECIST criteria)~        6. Cardiotoxicity analysis by means of echocardiography and NT-pro BNP with an interim~          analysis after 100 patients of each arm have completed the study~        7. Safety and tolerability~   "
215951|NCT00732901|"~     The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity~     and cue reactivity in cocaine dependent subjects and healthy controls and examine specific~     effects of escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine~     users.~   "
215952|NCT00732888|"~     This research study is being conducted through the University of Pittsburgh Cancer Institute~     (UPCI). It will evaluate the concentrations of Tasigna®, an oral drug used to treat some~     types of cancer, in the blood of healthy volunteers when taken with and without Tums Ultra®,~     a calcium product often used in the treatment of upset stomach and as a calcium supplement.~   "
215953|NCT00732875|"~     This trial is extension part of the P04280 (placebo-controlled, double-blind, randomized~     study of chronic treatment with infliximab in approximately 140 patients, NCT00202852). This~     study will be conducted at 6 study centers in South Korea. After completion of the last~     follow-up visit at Week 30 and code break in main double-blind trial, subjects randomized to~     the placebo group and those who were treated with an infliximab-containing regimen who~     maintained clinical response at the time of study completion will be provided with open-label~     infliximab for treatment of their conditions and additional safety data will be collected.~   "
215954|NCT00732862|"~     Hypoglycemia or low blood sugar is a very serious complication that diabetics experience.~     This is of great concern because there is a lack of available information of how Non Insulin~     Dependent Diabetic Mellitus patients (NIDDM) defend themselves against a low blood sugar.~     This is particularly disturbing since NIDDM patients are likely to require intensive~     treatment, and as a result, the risks of severe hypoglycemia to the NIDDM patient increase.~     The current proposal aims to provide information on how NIDDM patients can defend themselves~     against hypoglycemia, thus decreasing their risks for this severe complication.~   "
215955|NCT00732849|"~     The study was designed to test the hypothesis that immunonutrition and enteral nutrition~     would reduce the incidence of infectious complications in a population of malnourished~     patients following elective upper GI surgery~   "
215956|NCT00732836|"~     The goal of this clinical research study is find the highest tolerated dose of Abraxane~     (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer~     that has spread to the liver.~   "
215957|NCT00732823|"~     To evaluate the safety of the Compression Device to subjects with venous insufficiency and~     oedema.~   "
215958|NCT00732810|"~     To determine the activity of SCH 727965 in participants with breast cancer and in~     participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The~     standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study~     will also determine the activity of SCH 727965 treatment in participants who experience~     cancer progression after standard treatment.~   "
215973|NCT00732602|"~     The purpose of this study is to determine whether Glucose-dependent Insulinotropic~     Polypeptide (GIP) or Glucagon Like Peptide 2 (GLP-2) has an affect on the secretion of~     Glucagon from the pancreas in patients with type 1 diabetes mellitus.~   "
215959|NCT00732797|"~     The investigators primary aim is to test whether or not provision of the self-help booklet~     teaching VR exercises, with up to one hour of telephone support from a vestibular therapist,~     will be more effective than routine care in reducing symptoms in dizzy patients in primary~     care. The investigators will also explore the extent to which patients may benefit from the~     self-help booklet without support. The investigators will determine whether these models of~     delivery are less costly than routine care of dizzy patients, as they should reduce the~     number of patients seeking referral to secondary care for unnecessary assessments.~   "
215960|NCT00732784|"~     This research study is being conducted through the University of Pittsburgh Cancer Institute~     (UPCI). It will evaluate the concentrations of Gleevec®, an oral drug used to treat some~     types of cancer, in the blood of healthy volunteers when taken with and without Tums Ultra®,~     a calcium product often used in the treatment of upset stomach and as a calcium supplement.~   "
215961|NCT00732771|"~     The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can~     lower BP in patients with Primary hyperaldosteronism.~   "
215962|NCT00732758|"~     The study objective is to characterize the threshold levels of serum 25-hydroxyvitamin D for~     the definition of vitamin D insufficiency in 8-14 year old African American and Caucasian~     children.~      We propose a 6 month randomized placebo controlled trial of vitamin D (vitamin D3 1000 IU/day~     vs. placebo) initiated during October through March (during fall and winter) in 8 to 14 year~     old African American and Caucasian children. The results of the trial will help establish the~     cutoff threshold value of serum 25(OH)D for defining vitamin D insufficiency in preadolescent~     and adolescent children. Safety of vitamin D supplementation will be assessed by measuring~     serum calcium at 0, 2 and 6 months and by monitoring for adverse events. Currently~     recommended adequate intake for vitamin D of 200 IU daily may not meet the body's daily needs~     for vitamin D. Therefore, it is likely that a higher level of daily vitamin D intake may be~     needed to meet the body's skeletal and non-skeletal demands for vitamin D. Determining the~     dietary required intake of vitamin D for the prevention of vitamin D insufficiency during~     childhood has immense public health potential for addressing health disparities and ensuring~     better bone health during adulthood. The primary outcome measure will be serum 25(OH)D and~     parathyroid hormone (PTH). The secondary outcome measures will include: markers of bone~     formation (serum P1NP) and bone resorption (serum CTX).We will also examine differences in~     serum 25(OH)D, PTH, and markers of bone turnover in African American vs. Caucasian children.~   "
215963|NCT00732745|"~     RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. It is not yet known whether~     vandetanib is more effective than a placebo when given together with oxaliplatin and~     docetaxel in treating advanced cancer of the esophagus or gastroesophageal junction.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     vandetanib when given together with oxaliplatin and docetaxel and to see how well it works in~     treating patients with advanced cancer of the esophagus or gastroesophageal junction.~   "
215964|NCT00732732|"~     Green banana has been traditionally used in diarrheal and other diseases. Recent studies have~     shown that green banana is beneficial in children with diarrhea.~      The purpose of this study is to try green banana in a portable, storable and dosable form in~     infants with diarrhea.~      Infants with diarrhea and meeting the inclusion criteria will receive either green banana~     powder or placebo (microcrystalline cellulose). Their response will be monitored for 10 days.~     The subjects, parents and researchers conducting the study will not know whether banana~     powder or placebo is being given to that particular subject (double blind randomized study).~      Two hundred patients will be enrolled in 24 months.~   "
215965|NCT00732719|"~     To evaluate the safety of the prototype Compression Device in subjects with Oedema~   "
215966|NCT00732706|"~     Nerve blocks are an effective way to control pain after surgery. There are two major nerves~     that provide sensation to the knee: the femoral nerve provides sensation to the front of the~     knee and sciatic nerve provides sensation to the back of the knee. The femoral nerve has two~     branches. To locate the nerve, we use a machine called (Nerve stimulator) which is attached~     to the needle used for nerve block. Use of a nerve stimulator is standard practice for this~     procedure. Ultrasound is being increasingly used to locate nerves but is not used~     universally. We will use the nerve stimulator and ultrasound to locate the femoral nerve but~     patients will randomly be selected to enter a group looking at the stimulation of one or the~     other branches of the femoral nerve. The two branches when stimulated produce different~     muscle contractions in the thigh. We do not know from research which is the optimal~     contraction to position the needle to get the best block. After the knee replacement patients~     will still have the same analgesic medication available as patients would have received if~     they were not in the study.~   "
215967|NCT00732693|"~     The aim of the study is to determine whether physiological sex steroid replacement improves~     parameters of skeletal, cardiovascular and reproductive health of women treated with current~     sex steroid replacement regimens.~   "
215968|NCT00732680|"~     Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable~     distress. To date there is no definitive cure for these symptoms. Established treatment~     modalities include saline irrigation, surgical implantation of materials or simply use of~     cotton wads/ silicon cones to simulate the resistive action to airflow of the resected~     turbinates.~      This study will research the effectiveness of a new treatment modality in the treatment of~     Empty Nose Syndrome. This novel treatment method involves the use of botulinum toxin type A~     (Botox).~   "
215969|NCT00732654|"~     The purpose of this study is to determine if small oral and sublingual doses of milk protein~     are safe and effective in decreasing sensitivity to cow's milk in allergic children.~   "
215970|NCT00732641|"~     This study aims to assess the efficacy of peginterferon α-2b, compared to a control arm not~     receiving any maintenance treatment, in adult subjects with multiple myeloma who have~     responded to a prior induction therapy. Peginterferon α-2b will be given once weekly as an~     injection until disease progression or relapse, or for up to a maximum of 5 years (whichever~     occurs first).~   "
215974|NCT00732589|"~     The purpose of this study is to compare suprascapular nerve block with therapeutic ultrasound~     in stroke patients who have shoulder pain in weak side.~   "
215975|NCT00732576|"~     Omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have~     beneficial effects on the vasculature. Vitamin K2 is known for preventing vascular~     calcification. In this study we investigate a potential synergy between the effects of either~     fish or krill oil and menaquinone-7, which is one of K2 vitamins.~   "
215976|NCT00732563|"~     RATIONALE: Diagnostic procedures using fludeoxyglucose F 18 and a surgical probe may help~     find lymph node metastases in patients with early-stage non-small cell lung cancer.~      PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 works in detecting~     lymph node metastasis in patients with stage I or stage II non-small cell lung cancer that~     can be removed by surgery.~   "
215977|NCT00732550|"~     The purpose of this study is to determine the advantages of single trocar cholecystectomy~     over standard laparoscopic cholecystectomy.~   "
215978|NCT00732537|"~     Inhaled nitric oxide (iNO) improves oxygenation in term infants with respiratory failure.~     However, iNO has been primarily used in infants receiving mechanical ventilation. This study~     is a pilot study to determine if iNO given into an oxygen hood is effective in improving~     oxygenation in term and near-term infants who have poor oxygenation but who are not yet~     mechanically ventilated.~   "
215979|NCT00732524|"~     The purpose of this study is to compare two simple and safe emergency department discharge~     therapy for Type 2 Diabetes patients with severe hyperglycemia and with no indications for~     inpatient admission.~   "
215980|NCT00732511|"~     We are comparing the blood pressure-lowering effects of two marketed medications, Coreg CR~     and Toprol XL. Although both drugs reduce blood pressure by blocking the action of~     noradrenaline on beta-receptors in the blood vessels, Coreg CR also blocks alpha-receptors,~     which may provide added blood pressure-lowering. In addition, Coreg CR may have anti-oxidant~     actions. Cells which line blood vessels (termed endothelial cells) make nitric oxide (NO),~     which relaxes the muscle cells encircling the blood vessels, causing a reduction in blood~     pressure. When body cells use oxygen, they normally produce free radicals, which can~     destroy NO,leading to high blood pressure, heart damage and worsenimg of diabetes.~     Antioxidants remove free radicals and prevent or repair this damage. In this study we will~     measure endothelial cell function, blood vessel wall stiffness, NO in exhaled breath, and~     blood levels of substances which reflect NO production and destruction to determine if a pure~     beta-blocker (Toprol XL) differs from an alpha/beta blocker (Coreg CR) in these effects. We~     will also examine the mechanism by which such differences might occur.~   "
215981|NCT00732498|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90~     ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them~     without harming normal cells. Giving combination chemotherapy together with rituximab and~     yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.~      PURPOSE: This phase II trial is studying giving combination chemotherapy followed by~     rituximab and yttrium Y 90 ibritumomab tiuxetan to see how well it works in treating patients~     with relapsed stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.~   "
215982|NCT00732485|"~     Major burn injury causes significant insulin resistance on glucose and protein metabolism~     that persists for up to 6 months after the acute injury~      This project proposes to answer the following questions:~        1. Will fenofibrate given to burn patients with insulin resistance restore their insulin~          sensitivity?~        2. What is the relationship between mitochondrial dysfunction in muscle tissue as the~          causative mechanism of burn related insulin resistance?~        3. To what extent will the restored insulin sensitivity affect glucose and protein~          metabolism in muscle, regenerating wounds and the liver, i.e. ameliorate burn related~          hyperglycemia and protein catabolism?~   "
215983|NCT00732472|"~     The study drug which is an inhaled bronchodilator (lung airway relaxant)has been given to~     both healthy volunteers and to COPD patients before. This study will assess a new formulation~     of GSK573719. Many drugs are known to deteriorate over time. To make the study medicine less~     likely to deteriorate in its container, it is mixed with an inactive substance that helps to~     to maintain the quality of the study medicine. Previous studies have looked at GSK573719 with~     another inactive substance called Cellobiose Octaacetate (COA). This study will be looking at~     a new formulation of GSK573719 using Magnesium Stearate (MgSt) as the inactive substance.~     MgSt itself is not a medicine but is approved as a food ingredient and has also has been~     approved to be used in a number of marketed medical inhalers. The purpose of this study is to~     assess the safety and tolerability of compound GSK573719 with Magnesium Stearate for~     once-daily treatment of COPD(Chronic Obstructive Pulmonary Disease). This drug will be given~     to 2 groups of 12 people for 7 days. Group 1 will receive 250mcg or placebo and group 2 will~     receive 1000mcg or placebo. Group 2 will not be dosed until at least 6 people have completed~     dosing in group 1 without any significant safety concerns. The following safety measures will~     be assessed including: ECGs, heart rate, blood pressure, blood samples for safety labs, lung~     function and 24 hour monitoring of the heart. We will also take blood and urine samples to~     measure medication levels in the body.~      GlaxoSmithKline will be funding the research and it will be recruiting at Synexus in 7 of~     their centres in the UK.~   "
215984|NCT00732459|"~     The purpose of this study is to investigate the protective effect of electro-acupuncture~     preconditioning in patients underwent cardiac surgery.~   "
215985|NCT00732446|"~     Safety and efficacy of antibiotic steroid combination compared with individual administration~     in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis~     and/or conjunctivitis).~   "
215986|NCT00732433|"~     The purpose of this study is to develop computer programs to assist radiologists in finding~     breast cancer on mammograms and to compare the computer's accuracy of detecting cancers on~     direct digital and film mammograms.~   "
215987|NCT00732420|"~     To determined what dose of topotecan can be safely given with daily pazopanib.~   "
216001|NCT00732225|"~     A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices~     (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and~     anterior chamber space maintenance during non-eventful cataract surgery.~   "
215988|NCT00732407|"~     Aliskiren is a novel renin inhibitor approved for the treatment of hypertension. The effect~     of aliskiren on arterial stiffness, inflammation and oxidative stress has not been fully~     investigated yet.The aim of this study is to investigate the effect of aliskiren on arterial~     stiffness, platelet function and inflammation compared to losatan in patients with diabetes~     mellitus.~      We hypothesize that aliskiren will have a beneficial effect on arterial stiffness and~     platelet function in patients with diabetes mellitus.~   "
215989|NCT00732394|"~     To administer the MSDR® (Musculoskeletal Disorder Reporting) instrument to document the~     musculoskeletal profile of patients with chronic low back pain, a prospective,~     non-randomized, multicenter treatment trial~   "
215990|NCT00732381|"~     This study seeks to prospectively demonstrate that Nasonex is better than placebo in~     relieving nasal congestion in patients with seasonal allergic rhinitis.~   "
215991|NCT00732368|"~     This study examined the safety and effectiveness of long-term administration of mometasone~     nasal spray in patients with perennial allergic rhinitis. Patients received mometasone for 12~     weeks plus an additional 12 weeks if patient agreed to continue. Dose of mometasone could be~     decreased or increased during the study based on patient's response.~   "
215992|NCT00732355|"~     The study is designed to evaluate the performance of a rapid membrane test in a clinic or~     doctor's office setting to identify potential patients infected with syphilis and compare the~     results to currently licensed laboratory based tests.~   "
215993|NCT00732342|"~     310 alcohol abusing or dependent patients beginning intensive outpatient day treatment at~     community-based clinics will be randomly assigned to one of four conditions: (a) standard~     treatment as usual (ST) at the clinic without contingency management (CM); (b) standard~     treatment with contingency management for 12 weeks with a 0.5 probability of winning prizes~     for each negative sample submitted; (c) standard treatment with contingency management for 24~     weeks with a 0.34 probability of winning prizes for each negative sample submitted; or (d)~     standard treatment with contingency management for 24 weeks with a 0.5 probability of winning~     prizes for each negative sample submitted. We expect that contingency management will~     decrease alcohol use to a greater extent than non-contingency management treatment, and that~     availability of contingency management for 24 weeks may result in longer term benefits than~     12 week exposure to contingency management. This study will be the first to evaluate the~     effects of probability of winning prizes on response to contingency management.~   "
215994|NCT00732329|"~     The purpose of this study is to determine if a home based occupational therapy is effective~     in the treatment of dementia.~   "
215995|NCT00732316|"~     RATIONALE: Giving low doses of chemotherapy and antithymocyte globulin before a donor stem~     cell transplant helps stop the growth of cancer and abnormal cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer and abnormal cells~     (graft-versus-tumor effect).~      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works after~     busulfan, fludarabine, and antithymocyte globulin in treating patients with hematologic~     cancer or myelodysplastic syndrome.~   "
215996|NCT00732303|"~     Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent~     activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this~     study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.~   "
215997|NCT00732290|"~     Clopidogrel is a platelet aggregation inhibitor witch prevents thrombotic events in patients~     with atherosclerotic vascular disease. To date, 4 to 30 % of patients are considered as poor,~     low or non-responder to this therapeutic. However, drug-drug interactions may lead to~     decrease the clopidogrel responsiveness. Many arguments are in support to a drug-drug~     interaction between clopidogrel and fluoxetine (selective serotonin reuptake inhibitor). On~     the pharmacokinetic level, fluoxetine inhibits the cytochroms involved in the production of~     clopidogrel active metabolite. On the pharmacodynamic level fluoxetine could increase the~     risk of hemorrhage by inhibiting the serotonin platelet reuptake and thus enhance the~     antiplatelet effect of clopidogrel.~      The purpose of this study is to investigate the influence of fluoxetine on pharmacokinetic~     and pharmacodynamic of clopidogrel.~   "
215998|NCT00732277|"~     Severe bacterial infections affecting multiple body organs, called severe sepsis (including~     meningococcal sepsis), remain an important cause of death and disability among children.~     Although early recognition, powerful antibiotics, and good intensive care have improved~     outcome, we need new ways to further reduce the number of deaths. Research in adults has~     shown that steroid replacement therapy might be useful. However, children are known to~     respond differently to adults and a definitive trial in children is needed because of the~     potentially harmful as well as beneficial effects of steroids.~      This pilot study will provide the necessary information to allow the rational design of a~     large trial conducted at multiple hospitals investigating the role of corticosteroid~     replacement therapy in childhood sepsis. The study will provide information on how to measure~     the effects of steroids, information on length of therapy and a better understanding of how~     steroids work in children. The results emerging from this study will ultimately allow~     paediatric intensive care clinicians to know whether or not steroids are safe and/or useful.~      The primary objective of this open−label study is therefore to gather clinical and laboratory~     data with which to inform the design of a large phase 3 double blind randomised controlled~     trial (RCT). The study will provide basic limited safety data, information on length of~     therapy and an assessment of possible clinical and laboratory endpoints to be used in~     addition to mortality.~      Definition of sepsis:~      Presence of a documented infection (eg clinical evidence of pneumonia, skin or soft tissue~     infection, purpura fulminans, urinary tract infection, abdominal infection) or a diagnostic~     positive blood culture (community or hospital acquired) within the last 72 hours and at least~     two of the following, one of which must be abnormal temperature or leucocyte count[3] core~     temperature of >38.5°C or <36°C; tachycardia (mean heart rate >2 SD above normal for age);~     mean respiratory rate > 2 SD above normal for age; leucocyte count elevated or depressed for~     age.~      Definition of severe sepsis:~      Sepsis plus cardiovascular organ dysfunction (the need for at least 5mcg/kg/min dopamine or~     dobutamine, or any amount of adrenaline or noradrenaline support), acute respiratory distress~     syndrome (ARDS), or 2 or more other organ dysfunctions.~   "
215999|NCT00732251|"~     The purpose of this study is to investigate the efficacy of allopurinol as an augmentation~     agent for the prevention of mania in bipolar disorder patients with currently stable mood.~   "
216000|NCT00732238|"~     The specific objective of this clinical trial is to demonstrate that a multifaceted approach~     for treatment for catheter-related urinary tract infection (UTI) in patients with spinal cord~     injury is effective and feasible. We plan to test the following hypothesis: a multifaceted~     treatment approach that consists of immediate removal of the indwelling bladder catheter,~     selecting antibiotics based on the finding from a urine culture that is obtained through the~     newly inserted catheter, and a 5-day course of systemic antibiotics will effectively treat~     catheter-related infection that is limited to the lower urinary tract of patients with spinal~     cord injury.~   "
216002|NCT00732212|"~     The main purposes of this study are to compare clinical outcomes of two groups of patients~     with similar medical conditions (one with non-variceal upper gastrointestinal (UGI) lesions~     such as ulcers and another group with varices or portal hypertensive lesions) who are treated~     either with current standard visually guided endoscopic treatment according to stigmata of~     hemorrhage or with endoscopic Doppler endoscopic ultrasound probe (DEP) monitoring of blood~     flow in the lesion.~   "
216003|NCT00732199|"~     The purpose for this research protocol was to examine the role of breathing control~     mechanisms that determine the development of sleep-disordered breathing in the elderly. This~     proposal focused on key factors that contribute to the control of ventilation in elderly~     adults during sleep. The investigators studied the age-specific changes in ventilatory~     control in older and young adults during NREM sleep.~   "
216004|NCT00732186|"~     The purpose of the study is to assess the safety of ipilimumab and dasatinib combination~     therapy in patients with CML~   "
216005|NCT00732173|"~     RATIONALE: Participating in a diet and exercise program may improve the quality of life of~     overweight and obese patients who are in remission from endometrial cancer.~      PURPOSE: This randomized phase I trial is studying an exercise and healthy diet program to~     see how well it works compared with standard care in patients in remission from stage I or~     stage II endometrial cancer.~   "
216006|NCT00732160|"~     Determine the effect of aldosterone on how the body handles glucose (sugar).~   "
216007|NCT00732147|"~     Diabetes affects almost 21 million people in the United States. In this study we will test a~     drug called Pramlintide(Symlin), and see how it works to lower blood sugar and fat levels~     after a meal. Lowering high sugar levels and fat levels after a meal is very important in the~     prevention of the problems that persons with type 2 diabetes often encounter. Hypothesis is~     that Pramlintide will lower blood sugar and fat levels after a meal.~   "
216008|NCT00732121|"~     Background:~      Incretin hormones are hormones produced by the gut in response to food intake. These hormones~     help the body to control the metabolism of glucose (sugar). In particular, two incretin~     hormones (GLP-1 and GIP) cause the pancreas to secrete more insulin in response to high blood~     glucose levels. This helps the body to metabolize the glucose more effectively, lowering~     blood sugar levels. In addition to their effects on the pancreas, GLP-1 and GIP have effects~     on other tissues, including the brain, gut, fat cells and bone. A new class of oral drugs~     developed for the treatment of type 2 diabetes mellitus (T2DM) called DPP-4 inhibitors~     increases levels of the active forms of GLP-1 and GIP in the body by preventing their~     breakdown. This study tests whether a medicine in this class called sitagliptin (Januvia),~     which is commonly used to treat T2DM, affects markers of bone turnover in patients with T2DM.~     The hypothesis is that treatment with sitagliptin will increase markers of bone formation and~     decrease markers of bone resorption during a mixed meal, by enhancing active circulating~     levels of GLP-1, GIP and GLP-2.~      Methods:~      To address this question we will recruit patients with T2DM whose diabetes is controlled with~     either diet+exercise or with metformin (another medicine commonly used to treat T2DM).~     Subjects will undergo measurement of body fat and bone mineral density by DEXA scanning and a~     3-hour mixed meal test. During the mixed meal test blood samples will be taken to measure how~     much GLP-1 and GIP are produced. Markers of bone formation will also be measured in blood~     samples obtained during the mixed meal test. Subjects will then be randomly assigned to 8~     weeks of treatment with either sitagliptin (100 mg/day) or matching placebo (an inactive~     tablet that does not contain medication). Subjects will be seen 4 weeks after commencing~     treatment to assess safety and tolerability. After 8 weeks of treatment the meal test will be~     repeated. Subjects will then be washed off of their initial treatment (sitagliptin or~     placebo) for 1 week (that is, they will receive no study medication during this period).~     After the washout period, they will commence a second 8-week period of treatment with the~     other study medication (that is, if they received sitagliptin initially, they will receive~     placebo during period 2 and vice-versa). At the end of period 2, subjects will undergo a~     third mixed meal test with measurement of GLP-1, GIP and markers of bone turnover.~      Significance:~      Recent studies suggest that oral antidiabetic medications of the thiazolidinedione class,~     such as rosiglitazone (Avandia) and pioglitazone (Actos), may weaken bones, increasing the~     risk of fractures in older women with diabetes. The proposed study will test whether drugs of~     the DPP-4 inhibitor class, such as sitagliptin (Januvia), have beneficial effects on bone~     turnover by increasing the activity of GLP-1 and GIP. Results of this pilot study may suggest~     the need to perform longer-term studies to determine whether DPP-4 inhibitors increase bone~     mineral density and reduce the risk of fractures in patients with diabetes.~   "
216009|NCT00732108|"~     The purpose of this study is to determine whether topiramate effective in treating dizziness~     symptoms that are associated with migraine headaches.~   "
216010|NCT00732095|"~     Research has found that natural recovery (self-change) is a very common pathway to change for~     individuals with alcohol problems, accounting for nearly 75% of recoveries in several~     national surveys.~      Although few members of the public are aware that self-change is possible, it also is the~     case that many individuals with alcohol problems do not enter treatment because of the stigma~     or fear of being labeled. The proposed study is based on findings from a recent randomized~     controlled trial designed to promote self-change in the community for problem drinkers who~     had never been in treatment. Media advertisements were used to recruit 825 participants.~     Eligible respondents were sent assessment materials to complete. After the assessment~     materials were returned, participants were randomly assigned to receive two alcohol pamphlets~     that were freely available in the community or personalized feedback based on their~     assessment responses (e.g., how their drinking compared to national norms, health risks~     associated with their drinking). A 1-year follow up found that while there were no~     differences in drinking behavior between the groups, both groups had very substantial~     reductions in their drinking 1-year pre- to 1-year post-intervention. In an attempt to~     determine what accounted for the change, participants' reports of their drinking were~     evaluated with regard to critical study elements (e. g., when assessment materials were~     received). Surprisingly, results revealed that many changed after seeing the advertisement,~     and before receiving the assessment materials to complete. This suggests that either seeing~     the ad (Thinking about changing your drinking?) or a message in the ad (Did you know that~     75% of people change their drinking on their own?) may have catalyzed the change. To~     evaluate when change occurs and the mechanisms that may give rise to change, a randomized~     controlled trial involving 3 groups will be conducted. The groups will differ in whether they~     receive a message informing them that self-change is a common phenomenon (two groups will~     receive the message, one will not) and the occasion when the message is delivered (consenting~     to the study and before the assessment vs. with the intervention material). Comparisons made~     possible by the experimental design will allow an evaluation of the message as a precipitant~     of change. The use of Timeline Followback retrospective reports of daily drinking and~     recording of critical dates will allow statistical analysis of patterns of inflection (i.e.,~     change in drinking) related to seeing the ad, receiving the message, receiving and completing~     the assessment materials, and receiving the intervention materials. Possible explanations for~     how the message could function as a mechanism of behavior change are offered (e.g.,~     catastrophe theory, cognitive social learning theory). The ultimate objective of this~     research is to develop cost-effective, large scale interventions that can be viewed as an~     early stage in a public health, stepped care model by encouraging self-change for individuals~     with alcohol problems.~   "
216011|NCT00732082|"~     The overall purpose of this research is to evaluate the safety and toxicity of an~     investigational medication, IMP321, in patients being treated with gemcitabine. IMP321 is a~     synthetic protein (made in the laboratory to simulate a protein that your body makes on its~     own) and was designed to stimulate the immune system with the overall objective of improving~     the body's capacity to react to your pancreas cancer.~   "
216012|NCT00732069|"~     Little is known about how some drugs affect inflammation or clotting factors in people~     receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they~     do in people not undergoing hemodialysis or whether they could increase the risk of heart~     problems. The purpose of the study is to measure certain chemicals in the blood and see how~     those chemicals may change during hemodialysis when certain drugs are given.~   "
216013|NCT00732056|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of GRN163L in~     combination with paclitaxel and bevacizumab in patients with locally recurrent or metastatic~     breast cancer (MBC)~   "
216577|NCT00724568|"~     This research study is evaluating an investigational combination of four drugs called~     Revlimid® (lenalidomide), Velcade® (bortezomib), Dexamethasone and Doxil® (RVDD) as a~     possible treatment for newly diagnosed multiple myeloma.~   "
216014|NCT00732043|"~     High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to~     delay clinical prostate cancer progression and prolong the interval from primary treatment~     failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1~     study, to compare the effects of daily consumption of pomegranate liquid extract versus~     placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12, 24,~     36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.~   "
216015|NCT00732030|"~     Study evaluates the visual outcomes and patient satisfaction after implantation of a toric~     intraocular lens (IOL).~   "
216016|NCT00732017|"~     The investigators hypothesis is that HVPC with negative polarity diminishes local~     post-traumatic edema in ankle sprains. Therefore, the objective of this study was to analyze~     the effect of HVPC on edema secondary to ankle sprains in humans.~   "
216017|NCT00732004|"~     The principal aim of this project is to determine the time course of development of contact~     lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The~     secondary aim of the study is to determine whether the time course of development of contact~     lens and contact lens case contamination varies between two different contact lens care~     systems.~   "
216018|NCT00731991|"~     The general purpose of this research project is to use surface electromyography to compare~     the effect of Active Release Technique versus Proprioceptive Neuromuscular Facilitation on~     the electrical activity of the upper trapezius muscle at rest and during contraction.~   "
216019|NCT00731978|"~     The purpose of this study is to evaluate if the InSpectra StO2 Monitor can safely guide the~     amount of fluid needed during colorectal surgery.~      The study hypothesis is that intraoperative fluid limitation can be safely accomplished when~     guided by StO2 monitoring, and that this fluid restriction regimen will result in a reduction~     in postoperative morbidity when compared to standard monitoring and fluid therapy.~   "
216020|NCT00731965|"~     Background:~      The safety of vaccination in patients with autoimmune diseases using immune suppressive~     therapy is often discussed. Previous studies in Juvenile Idiopathic Arthritis (JIA) patients~     showed no increase in disease activity after immunisation with dead vaccines. The safety of~     the live attenuated Measles, Mumps, Rubella (MMR) vaccination was assessed retrospectively in~     JIA patients and no increase in disease activity was found. However, this must be~     prospectively confirmed. In addition, it is unknown whether vaccination is effective, since~     the immune response to vaccination may be diminished due to immunosuppressive therapy for the~     underlying disease. Finally, the influence of MMR vaccination on the immune system of JIA~     patients has not been studied. Among others, regulatory T-cells (Tregs) should control the~     immune response and prevent destructive autoimmune responses after environmental triggers~     such as vaccination.~      Objective:~      The aim of the present study is to investigate the safety and efficacy of the MMR booster~     vaccination and its influence on immune regulatory mechanisms in children with Juvenile~     Idiopathic Arthritis.~      Method:~      JIA patients aged 4 to 8 years and treated by the pediatric rheumatology units from various~     University Medical Centers in the Netherlands, are asked to participate in a prospective~     study. In the Netherlands, measles-mumps-rubella (MMR) vaccination is included in the~     National Vaccination Program and is normally administered at age 9. Included patients will be~     randomised for early vaccination (age group 4 to 8yr at entry of the study) or at age 9 as is~     routinely done according to the National Vaccination Program. Prior to and after vaccination~     the investigators will assess disease activity and collect blood.~      Outcome:~      During a 12 month follow-up period the investigators will register disease activity and~     side-effects at different moments in time to determine safety of vaccination. The efficacy of~     the vaccine will be studied according to antibody levels and function against measles, mumps~     and rubella in the blood. Tregs will be isolated and their functionality will be determined~     using the blood cells collected during follow-up. This enables us to study the role influence~     of vaccination on regulatory mechanisms in our immune system.~   "
216021|NCT00731952|"~     The purpose of this study is to find out what effects (both good and bad) two medications~     (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is~     dose escalating meaning that patients will receive different doses of medication depending~     on when they enter the study. Participation in the study will last approximately 3 months and~     will include an initial screening visit, a visit once each week for 3 weeks to receive the~     study medications, and then 2 additional visits around the time of your surgery to remove~     your lung cancer tumor.~   "
216022|NCT00731939|"~     The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.~   "
216023|NCT00731926|"~     oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance~   "
216024|NCT00731913|"~     To better understand surgeon preference when using synthetic, absorbable, monofilament suture~     by comparing two similar appearing FDA-approved sutures, Monosyn (Aesculap) and Monocryl~     (Ethicon).~   "
216025|NCT00731900|"~     Topiramate (TPM) is an antiepileptic drug with a unique mode of action that is often useful~     in patients refractory to other drugs. However its use is restricted by the high incidence of~     cognitive adverse drug reactions (ADRs) that are associated with TPM exposure. TPM has been~     shown to cause particular cognitive ADRs, characterized by verbal fluency, attention, working~     memory and language deficits, at a much higher rate than other antiepileptic drugs. There do~     not appear to be obvious differences between patients that do or do not experience cognitive~     ADRs when on TPM (e.g. age, sex, concomitant medications, diagnosis), which suggests a~     genetic contributor.~   "
216026|NCT00731887|"~     To examine long term physical and psychosocial outcomes of pediatric burn survivors. We want~     to learn about thoughts, feelings, coping style, social support, and overall adjustment~     following burn injury.~   "
216027|NCT00731874|"~     Tacrolimus (Prograf) is a medication that is commonly used in patients who receive a kidney~     transplant. It is considered to be one of the most important medications that prevent~     rejection of the transplant kidney by suppressing the immune system. Although tacrolimus is~     good at preventing rejection, it does have some unwanted side effects. These side effects~     include high blood pressure, increase in blood sugar, headache, and tremor. In addition,~     tacrolimus causes some damage to the transplant kidney over time, by causing healthy tissue~     to turn into scar tissue that does not function as well as healthy tissue. Therefore, kidney~     function may be reduced over time. In the first three months after kidney transplant, Prograf~     levels are kept between 8 to 10 ng/mL. This study will compare two groups of patients that~     will both have their tacrolimus dose reduced slowly over three months to prevent rejection~     while decreasing the risk of causing toxic effects to the kidney. One group will have their~     Prograf levels kept between 6 and 8 ng/mL, while the second group will have their levels kept~     between 3 and 5 ng/mL. We will then compare the two groups to see if there are any~     differences in their kidney function over time.~   "
216028|NCT00731861|"~     This study will evaluate PTK787, a new oral drug that stops blood vessel development, in~     combination with Paclitaxel in patients with advanced solid tumors.~   "
216578|NCT00724555|"~     The purpose of this study is to increase treatment of acute stroke with tissue plasminogen~     activator (tPA) across the District of Columbia. This study, however, will not evaluate tPA~     as an intervention.~   "
216029|NCT00731848|"~     This study is an open-label extension to the double-blind GUP-0205-1 and double-blind~     extension GUP-0205-1XX studies. High concentrations of anti-oxidants in pomegranate seeds~     present a potential strategy to delay clinical prostate cancer progression and prolong the~     interval from treatment failure to hormonal ablation. Eligible male subjects were previously~     assigned to the placebo group in the double-blind core study or the double-blind extension~     study and were diagnosed with disease progression while on placebo treatment. Upon satisfying~     all entry criteria, the subjects will receive open-label pomegranate extract for up to 48~     months in the absence of further disease progression or intolerable toxicity.~   "
216030|NCT00731835|"~     You are being asked to take part in this study because your doctor has determined that you~     have an ischemic foot ulcer. This research study will compare two approved standard of care~     treatment modalities for the management of ischemic foot ulcers. The ischemic foot ulcer~     (wound) on your foot is a result of a blocked artery in your leg. The wound can sometimes be~     healed with wound care alone, which includes dressing changes with creams and removing~     (debriding) the dead tissue. Alternatively, the significant narrowing or blockage in one of~     the arteries in your leg can be treated with several endovascular treatment techniques~     including:~        -  angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or~        -  stent placement~        -  atherectomy~      The hypothesis of this study is that early endovascular or surgical intervention in subjects~     with moderate arterial insufficiency and a non-healing foot ulcer results in a higher overall~     incidence of wound healing in a significantly shorter period of time.~   "
216031|NCT00731822|"~     The purpose of this study is to assess the safety and efficacy of a single dosage strength of~     GW685698/GW642444 in subjects with Chronic Obstructive Pulmonary Disease (COPD).~   "
216032|NCT00731809|"~     18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT)~     is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in~     the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Such~     increased uptake has been described not only in neoplastic lesions but also in inflammatory~     lesions. In this condition, uptake has been correlated with local stimulation of tumor~     necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may~     be observed in the bowel, especially the cecum, and has limited the use of PET in~     inflammatory bowel diseases. The advantage of combined PET and CT devices lead to significant~     improvements in the interpretation of the bowel areas, and greatly reduces the number of~     false-positive findings in the gastrointestinal tract.~   "
216033|NCT00731796|"~     This study is designed in two Phases. In phase 1, the Functional Outcome Measure will be~     tested to determine its validity and reliability in three populations, subjects that have not~     had a stroke and have no visual field defect, subjects that have had a stroke but do not have~     a visual field defect, and lastly subjects that have had a stroke and have a visual field~     defect. The second phase will employ an amended version of the functional outcome measure to~     be administered to two groups of subjects. The first group of subjects will be those subjects~     diagnosed with a visual field defect from retrochiasmatic insults and they will perform~     vision restoration therapy. The second group with a similar diagnosis to the first but who do~     not undergo vision restoration therapy.~   "
216034|NCT00731783|"~     The purpose of this study is to determine whether measures to eliminate the Staph germ from~     the skin of the index patient (with a special ointment and soap) are more effective when~     performed by everyone in the household rather than the patient alone, and whether these~     methods are effective in preventing future Staph infections. The investigators hypothesize~     that there will be a greater number of households who are successful in eradicating the staph~     germ from the index patient when all members of the household participate than households~     where only the index patient is treated.~   "
216035|NCT00731770|"~     Fluticasone, an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are~     approved for use in the management of COPD. Fluticasone/salmeterol has been shown to~     significantly improve FEV1 and decrease COPD symptoms (Calverley et al. 2003, 2007). Inhaled~     corticosteroids have been shown to decrease frequency of COPD exacerbations (Gartlehner et~     al. 2006) and long acting bronchodilators demonstrated a reduction in dyspnea, increased~     airflow and reduction in hyperinflation in patients with symptomatic COPD (Ramirez-Venegas et~     al. 1997). Specifically, salmeterol has also been shown to have a positive effect on symptoms~     and health status of patients with COPD when added to usual treatment (Stockley et al. 2006).~      Previous research of subjects from our group with asthma has shown salmeterol to be~     associated with sustained improvements in morning PEF, protection from nighttime lung~     function deterioration and improvement in patient perception of sleep (Wiegand et al. 1999).~     This study has not been performed in patients with COPD nor has the effect of salmeterol with~     fluticasone on sleep quality been assessed.~      AIM: The aim of this study is to determine the effect of fluticasone/salmeterol on sleep~     quality in patients with COPD and to compare efficacy of Advair 250 compared to placebo on~     sleep.~      The hypothesis is that there would be a significant improvement in sleep quality when~     patients are placed on fluticasone/salmeterol as compared to placebo.~   "
216036|NCT00731757|"~     The purpose of this study is to determine the safety and efficacy of Humira in the treatment~     of cutaneous sarcoidosis.~   "
216049|NCT00731588|"~     OUR OVERALL HYPOTHESIS is that post-transfusion survival of allogeneic and autologous RBCs~     can be accurately quantified in anemic human infants using biotin-labeled RBCs combined with~     mathematical modeling that adjusts for confounding factors commonly encountered in neonates.~     These confounding factors include 1) dilution of labeled RBC as a result of growth stimulated~     erythropoiesis, anemia stimulated erythropoiesis, and blood transfusion; 2) loss of labeled~     RBC due to laboratory phlebotomy; and 3) variable RBC life spans resulting from RBCs having~     been produced at different developmental periods and under varying rates of erythropoiesis.~     In contrast to infants, adjustment for these factors is not necessary in healthy adults under~     conditions of steady state erythropoiesis. Instead in adults, RBC survival is typified by a~     linear decline in concentration of labeled RBCs over time. When this line is extrapolated to~     zero concentration, the intercept with the time axis represents the mean potential lifespan~     (MPL) of RBCs. (<7 d) and stored (>21 d) allogeneic adult RBCs transfused in the same infant.~   "
216579|NCT00724542|"~     The purpose of this study is to determine whether therapeutic intervention on impaired~     glucose tolerance in patients with coronary heart disease can decrease the incidence of new~     onset DM.~   "
216037|NCT00731744|"~     There is a growing interest in generating dendritic cells (DCs) for using as vaccines.~     Several cytokines, especially stem cell factor (SCF) and FLT3-ligand (FL), have been~     identified as essential to produce large numbers of myeloid precursors and even to increase~     DC yield obtained by the action of granulocyte-macrophage colony-stimulating factor (GM-CSF)~     and tumor necrosis factor alpha (TNF-α). However, there are few studies on the effect of the~     early-acting cytokines, commonly used to expand CD34+ progenitor cells, on DC generation.~      We have established a serious of functional analysis of maturated or immaturated DCs~     including surface markers screening or cytokine production. Here, we design this two-year~     project to evaluate the possible methodology in the generation of CD14+CD1a- and CD14- CD1a+~     myeloid DC precursors from CD34+ cells. In the first year of the project, we will set up the~     standard protocol to generate DC precursors from cord blood stem cells. In the first step, we~     will isolate CD34+ cells from cord blood and amplify these cells. Purity of the CD34+ cell~     populations obtained will be greater than 90%. In the next step, these primary cultures of~     CD34+ cells will treat with early-acting cytokines such as GM-CSF and IL-4 to further~     induction into dendritic cells. Functional analysis of dendritic cells would be performed in~     this stage. In the second year of the project, we will further evaluate the induction of DCs~     by CD34+ stem cells could be affected by combination of mesenchymal stromal cells. These~     results of this research with CD34+-based DCs induction provide the basis for materials to~     develop the DC-based vaccine against viral and fungal infections, and might be a powerful~     tool in anti-tumor immunotherapy.~   "
216038|NCT00731731|"~     This phase I/II trial studies the side effects and best dose of vorinostat when given~     together with temozolomide and radiation therapy and to see how well they work in treating~     patients with newly diagnosed glioblastoma multiforme. Vorinostat may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving vorinostat together with temozolomide and~     radiation therapy may kill more tumor cells.~   "
216039|NCT00731718|"~     The goal of this study is to see if heated air will kill head lice and their eggs. The~     treatment visit is approximately 1 hour long with a follow up phone call.~   "
216040|NCT00731705|"~     The doctors in the Bone Marrow Transplant Service at the Indiana University Cancer Center are~     working to better understand how the immune cells that cause graft-versus-host disease (a~     major complication of stem cell transplantation in which the donor immune cells attack the~     patient's organs) can be selectively removed from the graft, leaving other immune cells that~     fight infections.~   "
216041|NCT00731692|"~     The purpose of this study is to evaluate whether FTY720 is effective in delaying MS~     disability progression compared to placebo in patients with PPMS. This was an open-label,~     single-arm extension study to a double-blind, randomized multicenter, placebo-controlled,~     parallel-group core study. The core study completed and eligible patients enrolled into the~     extension study at the next scheduled or unscheduled core study visit. All patients,~     regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension~     study. The extension study was terminated early after the results of the core study became~     available showing that the study did not meet its primary endpoint which was defined as~     confirmed disability progression in this population~   "
216042|NCT00731679|"~     To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in~     providing adequate relief of IBS symptoms.~   "
216043|NCT00731666|"~     This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile~     Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device.~     It will incorporate a modified method of cylinder sizing during implantation and a~     max-inflate technique after implantation.~   "
216044|NCT00731653|"~     The objective of this study is to allow patients who have participated in the precursor study~     of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01)~     to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination~     with an increased dose of BCI-049.~      The safety and tolerability of this higher dose of the combination will be evaluated, as will~     the treatment effect in reducing symptoms of depression in patients with MDD.~   "
216045|NCT00731640|"~     Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or~     phakic eye.~   "
216046|NCT00731627|"~     Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH)~     affects 7000 patients each year in the UK and is a source of considerable death and~     disability, even in young adults. Recent observations indicate that these bleeds can cause~     reduced cerebral blood flow which leads to a bad outcome. High rates of death and disability~     occur, and are particularly prevalent when low cerebral blood flow results in stroke.~     Prevention of cerebral artery spasm and improvement in blood vessel reflexes are the target~     of modern therapy. Candidate drugs include statins which have an impeccable safety record and~     multiple potential beneficial actions (improve cerebral blood flow, reduce inflammatory~     processes, reduce adverse blood coagulation) following SAH.~      The investigators plan to use a statin, Simvastatin (40 mg) to improve cerebral blood flow~     and reduce inflammation. We have already completed a phase 11 study (n=80) which demonstrated~     potential benefits for acute statin therapy following SAH, and the investigators now wish to~     conduct a multi-centre phase 111 study to explore any potential clinical benefits in a larger~     population (n=1600). The purpose is to see whether the positive effects of statins seen in~     our phase II study translate into clinical benefits - both short term (e.g. reduced need for~     intensive care) and long term (outcome and wellbeing at 6 months).~   "
216047|NCT00731614|"~     The goal of this study is to test whether a combination of cognitive-behavior therapy and~     mirror training reduces phantom limb pain for veterans with amputations.~   "
216048|NCT00731601|"~     A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators~     hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.~   "
216078|NCT00731198|"~     The aim of the present study was to evaluate the use of drotaverine hydrochloride versus~     hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.~   "
216580|NCT00724529|"~     The purpose of this study is to understand the safety and effectiveness of infliximab when~     used in clinical practice. This is a post-marketing surveillance study.~   "
216050|NCT00731575|"~     The purpose of this study is to study prospectively the early clinical and immunological~     events in children susceptible to rhinovirus induced early wheezing (i.e., recently found~     highest risk factor for recurrent wheezing/asthma) and the efficacy of systemic~     corticosteroid to modify these events.~      Up to 50% of children suffer from acute wheezing before school-age. The prevalence of~     childhood asthma is 5-7%. Although pediatric asthma is mainly allergic, the exacerbations are~     associated with respiratory viral infections in 95% of cases. The means to predict asthma~     from environmental factors have been limited mainly to sensitization to aeroallergens (3-fold~     risk), which start to develop usually at 2-3 years of age. VINKU 1-study (orig. VINKU-study)~     discovered simultaneously with two other groups, that early wheezing associated with~     rhinovirus, the common cold virus, is the strongest predictor of recurrent wheezing/asthma~     (up to 10-fold risky). Noteworthily, viral infections work as risk markers already during~     infancy, a lot earlier than the sensitization to aeroallergens. The investigators also found~     retrospectively that early wheezers affected by rhinovirus responded to 3 day course of oral~     prednisolone (inexpensive and widely available treatment): recurrent wheezing decreased by~     50% during following 12 months and the difference appeared to continue. VINKU 5V-study is~     currently investigating the clinical history, prevalence of asthma and airway hyperreactivity~     of these same children at school-age. The mechanism of rhinovirus associated risk or why they~     respond to prednisolone are largely unknown. However, the susceptibility to rhinovirus~     infections is associated with atopy and therefore it is possible these children may have~     impaired anti-inflammatory (Treg) responses and more likely to wheeze with any~     pro-inflammatory response (Th1 or Th2). Moreover, they may not effectively clear viruses,~     because they can not limit rhinovirus to nose and it spreads to lower airways and causes~     wheezing. VINKU 2-study will prospectively investigate the immunological events in young~     first-time wheezers affected by rhinovirus, and prospectively study the clinical efficacy of~     systemic corticosteroid in them. Most likely these children will benefit from the drug in~     terms of less recurrent wheezing, the investigators will also explore immunological effects~     of the drug and their link to clinical efficacy. The results are expected to give basis for~     the prevention of asthma and for the development of new treatment strategies and they can be~     directly applied to clinical medicine.~   "
216051|NCT00731562|"~     1. To estimate the absorption of a single oral dose of a controlled release varenicline~          tablet under fed and fasted conditions.~        2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a~          varenicline controlled release tablet under fed and fasted conditions.~   "
216052|NCT00731549|"~     To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance~     treatment in patients with schizophrenia.~   "
216053|NCT00731536|"~     The purpose of this study is to examine reports of the cancer called hepatosplenic T-cell~     lymphoma (HSTCL) in the Dutch National Database of Pathology (Pathologisch-Anatomisch~     Landelijk Geautomatiseerd Archief or PALGA) during the years 1995 to 2008.~   "
216054|NCT00731523|"~     The purpose of this study is to compare the pharmacokinetics of FTY720 and its metabolites in~     patients with severe renal insufficiency and in matched, healthy volunteers. This study will~     allow a better understanding of the effects of renal insufficiency on the disposition of~     FTY720.~   "
216055|NCT00731510|"~     During a multi−week expedition to the Himalaya, we aim to investigate i) whether dietary~     supplementation with carbohydrate drinks and gels can improve physical performance; and ii)~     the underlying mechanisms for any observed changes in performance.~      We hypothesise that i) carbohydrate supplementation will improve physical performance; and~     ii) the underlying mechanism of this improvement in performance will include maintenance of~     body glycogen (sugar) stores, prevention of dehydration and decrease in the incidence of~     acute mountain sickness.~   "
216056|NCT00731497|"~     The importance of waterborne gastrointestinal illness throughout the developing world, the~     existence of a cheap and effective intervention (SODIS), the concurrent limited dissemination~     program for SODIS, the need for a controlled evaluation of the effectiveness of SODIS under~     actual field conditions, and the experience of our tri-national collaborative research team~     in successfully conducting large scale drinking water intervention and observational studies~     in both the United States and the developing world encourage us to propose the following~     randomized controlled trial in which our specific aims are to:~        -  Evaluate the hypothesis that SODIS reduces the incidence of gastrointestinal illness in~          660 children under the age of five years in rural Bolivia that are randomly selected~          from 22 villages ;~        -  Define, through an extensive microbiologic testing component, the baseline rates of~          pathogen-specific diarrheal illnesses and the pathogens responsible for the differences~          in diarrheal illness between active and control groups;~        -  Document the actual use and acceptance of SODIS by participants in the study;~        -  Assess the cost-effectiveness of SODIS and the social and economic impact of SODIS at~          household level;~        -  Examine through mathematical disease modelling the effects of the presence of multiple~          transmission pathways within a village on the preventable fraction estimate due to the~          introduction of SODIS.~   "
216057|NCT00731484|"~     The objective of this study is to validate the performance of the OcuSense TearLab™~     osmolarity test when performed in physician office laboratories (POL) by health care~     professionals using human tear fluid collected from volunteer subjects and contrived tear~     samples.~   "
216058|NCT00731471|"~     This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are~     infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.~   "
216059|NCT00731458|"~     Ocular Coherence Tomography (OCT) is a non-invasive ophthalmologic test that uses reflected,~     unheated, non-concentrated visible light in order to scan and provide a 2-dimensional~     topographic analysis of the retina and optic nerve. It has wide diagnostic utility especially~     in patients with clinically significant macular edema, glaucoma, and other retinal eye~     diseases. At the University of Chicago, we have utilized the Stratus brand OCT (Carl Zeiss~     Inc) for the past 5 years. Recently we have acquired a beta version of the company's new~     model, the Cirrus HD-OCT (Carl Zeiss Inc.) which features improved resolution, shorter~     scanning time and a more user-friendly interface. The purpose of this study is to compare~     findings between the two models in patients with different common and uncommon eye diseases,~     including diabetic macular edema, glaucoma and age-related macular degeneration. We~     hypothesis that the Cirrus OCT is able to accurately quantify eye pathology compared to~     Stratus OCT.~   "
216060|NCT00731445|"~     This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced~     hepatocellular carcinoma~   "
216061|NCT00731432|"~     Diabetes increases the incidence and severity of periodontal inflammation and disease, and~     periodontal disease causes an increase in the severity of diabetes by worsening glycemic~     control and increasing insulin resistance.The Transmucosal Herbal Periodontal Patch (THPP) is~     a transmucosal patch containing an herbal compound that has an anti-inflammatory effect on~     gingival tissue.The primary objective of this study is to determine the efficacy of the~     Transmucosal Herbal Periodontal Patch (THPP) compared with placebo patch (PP) in reducing~     gingival inflammation at the site of placement in diabetic patients. We also aim to determine~     if the THPP decreases gingival inflammation throughout the mouth and the safety of THPP~     compared with placebo patch when applied to the mucosa in the treatment of gingival~     inflammation in diabetic patients.~   "
216062|NCT00731419|"~     Background:~      When considering any malignancy with limited life expectancy, palliation and quality of life~     are paramount. Owing to the limited centres offering ERCP and endoscopic palliation in the~     South African state sector, patients often travel vast distances and spend large amounts of~     time away from family and social support structures, severely impairing their quality of~     life. Stent occlusion with resultant readmission to an ERCP accredited centre obviously~     compounds this problem.~      The hypothesis we propose to test is whether metal stents as a primary procedure result in~     better patency rates, are more cost effective and improve quality of life than plastic~     stents. We propose to do this by means of a randomised trial determining the best method of~     palliation for inoperable distal common bile duct malignancies in the South African context.~      Primary end-point Assessing the cost of metal versus plastic stenting in inoperable malignant~     distal common bile duct strictures in patients with expected survival of 3 months or more as~     palliation of symptomatic obstructive jaundice. Cost to be assessed in terms of hardware,~     hospital stay and readmissions for stent occlusion(patency) and complications Secondary~     end-point Assessing quality of life using a validated scoring system(EORTC QLQ 30) in~     patients receiving a metal or plastic biliary stent as definitive means of palliation of~     malignant obstructive jaundice~      Hypothesis to be tested Metal stents are superior to plastic stents in terms of patency,~     resulting in more cost effective palliation of inoperable malignant jaundice and better~     quality of life due to fewer stent occlusions/episodes of cholangitis.~   "
216063|NCT00731393|"~     The aim of the present study is to assess the reactogenicity and immunogenicity of a~     thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the~     standard formulation of Influsplit SSW® 2003/2004.~   "
216064|NCT00731380|"~     The purpose of this study is to determine the highest dose of a ABI-007 that can be given~     with cisplatin and 5-fluorouracil without causing intolerable side effects in patients with~     advanced head and neck cancer.~   "
216065|NCT00731367|"~     This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two~     AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both~     protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization~     assignment, one protocol of care will have the AQUACEL Ag initially covered with a gauze~     dressing to create an adherent state and in the other protocol of care the AQUACEL Ag will be~     covered with a transparent film to maintain a gelled state.~      The primary objective of the study will be to quantify the proportion of subjects healed at~     14 days. Secondary objectives will include: time to healing, degree of pain at dressing~     change and while wearing the dressing, simplicity of use, resources used in treatment and~     safety. Approximately 68 subjects will be enrolled from 10 centers from within the US and~     Canada.~   "
216066|NCT00731354|"~     This study is being done to compare two commonly available types of body contouring,~     VASER-Assisted Lipoplasty (VAL) and Suction-Assisted Lipoplasty (SAL), and to decide if one~     procedure is preferred by patients and/or surgeons over the other. Participants will have VAL~     on one side of their body and SAL on the opposite side.~   "
216067|NCT00731341|"~     The purpose of the current study is to evaluate the technical success, safety and procedure~     feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women~     who do not desire further pregnancies using Galil Medical's 17-gauge 400mm Argon-based~     cryoablation needles~   "
216068|NCT00731328|"~     RATIONALE: Giving low doses of chemotherapy and antithymocyte globulin before a donor stem~     cell transplant helps stop the growth of abnormal cells. It may also stop the patient's~     immune system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining abnormal cells (graft-versus-tumor~     effect).~      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works after~     busulfan, fludarabine, methylprednisolone, and antithymocyte globulin in treating patients~     with bone marrow failure syndrome.~   "
216069|NCT00731315|"~     Our study aims to test the utility of computer-assisted treatment for uncomplicated,~     recurrent urinary tract infections (UTIs) for women receiving care in safety net health care~     facilities. As of November 2009, we are also testing the utility of computer-assisted~     treatment for certain types of complicated cystitis (i.e. women with voiding symptoms and one~     of the following complicating symptoms: fever, flank pain, or symptoms greater than 7 days).~   "
216070|NCT00731302|"~     This study examine whether patients with lupus respond to aspirin , and if not, if that is~     related to inflammation. We examine the ability of aspirin to inhibit the production of~     thromboxane in patients with lupus and controls and see if aspirin insensitive thromboxane~     production is inhibited by meloxicam.~   "
216071|NCT00731289|"~     The aim of this study was to analyse the difference of the functional and clinical outcome~     after intraarticular treatment of patients with osteoarthritis of the knee with a single~     injection of hyaluronan (HA) or Triamcinolone (TA) with respect to the quality of life during~     the study period.~   "
216072|NCT00731276|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in~     treating Asian patients with solid tumors.~   "
216073|NCT00731263|"~     The purpose of the study is to assess the safety, tolerability and pharmacokinetics of~     AZD8055 and determine the maximum tolerated dose to take into phase II trials.~   "
216074|NCT00731250|"~     This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by~     capsaicin challenge~   "
216075|NCT00731237|"~     This trial is to assess physician-determined XIENCE V® EECSS acute performance,~     deliverability and resource utilization in the catheterization lab during commercial use by~     various physicians with a range of coronary stenting experience~   "
216076|NCT00731224|"~     This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of~     rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26)~     initiating therapy for the first time with a cholinesterase inhibitor, and in patients who~     were unresponsive to previous cholinesterase inhibitor treatment in a community setting.~   "
216077|NCT00731211|"~     This is a Phase II, non-randomized, open-label, single-arm study in patients with metastatic~     renal cell carcinoma who have received one prior targeted therapy with either sunitinib or~     bevacizumab. The planned enrollment for this study is 60 patients.~   "
216079|NCT00731185|"~     This study was conducted to evaluate the effectiveness of mometasone nasal spray in~     preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal~     polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS)~     on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and~     continued for up to 24 weeks or until relapse.~   "
216080|NCT00731172|"~     phase 2 study. Target disease: Crohn's disease.~      Rational and relevance to IBD patients:~      Copaxone is known for its high safety profile and for acting as an effective immunomodulatory~     agent for the treatment of MS. . In experimental models of IBD, a beneficial effect of~     Copaxone was demonstrated where significant amelioration of macroscopic colonic damage,~     preservation of the microscopic colonic structure, reduced weight loss, and improved~     long-term survival in treated compared with untreated mice was demonstrated. In addition,~     Copaxone suppressed the proliferation of local mesenteric lymphocytes to syngeneic colon~     extract, significantly reduced the overall secretion of TNF-α and induced the secretion of~     transforming growth factor (TGF)-β. The ability of Copaxone to effectively modulate the~     clinical manifestations and the detrimental immune response involved in experimental colitis,~     together with its high safety profile support its potential effect as a new treatment for CD.~      Patients: patients with moderately active Crohn's disease as indicated by a CDAI 220 - 450,~     whose diagnosis was done more than 3 months before enrollment.~      Study objectives: to test the efficacy and safety of Copaxone in CD patients.~      Study design: This will be a single center, randomized, double blind placebo controlled phase~     2 study.~      Subjects will be assessed for study eligibility 1 to 2 weeks prior to baseline Eligible~     patients will be enrolled into the study after signing an informed consent form and allocated~     in a 1.5:1 ratio to receive either Copaxone or placebo. A total of 50 patients will be~     recruited.~      Subcutaneous injections (Copaxone or Placebo) will be administered daily through week 12.~     Patient assessment of safety and efficacy will be made at weeks 0,4,8,12 and 16.~      At week 12 non-responders would be offered an open label arm with daily Copaxone 20mg for the~     next 12 weeks~   "
216081|NCT00731159|"~     Our aim is to evaluate the potential of a new laboratory method that measure sperm~     capacitation to predict fertilization of oocytes in patients that undergo IVF treatments~   "
216082|NCT00731146|"~     Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are~     undergoing shoulder surgery. This block has a low, but still significant, rate of~     complications. Reducing the volume of local anesthetic given during the block may allow some~     of these complications to be avoided. Participants will be randomly assigned to a group to~     undergo ISBPB under ultrasound or nerve stimulator guidance. Each group will initially~     receive 10mL of local anesthetic. The volume used for each subsequent patient depends upon~     the success or failure of the previous patient's block - a failure will cause the volume~     given to increase by 2.5mL, while a success will cause the volume to decrease by the same~     amount. We hypothesize that the minimum effective anesthetic volume in 50% of patients will~     be significantly lower in the ultrasound guided group than in the nerve stimulator group. We~     further hypothesize that this lower volume will lead to a decreased rate of complications.~   "
216083|NCT00731133|"~     This 8 week, open-label pilot clinical trial will examine the safety and tolerability of~     disulfiram at 250 mg/day in up to fifteen methamphetamine dependent individuals. After~     undergoing screening procedures (approximately one week), eligible subjects will enter the~     study proper attend clinic every weekday during week 1 of the trial in order to receive the~     disulfiram under observation and complete assessments. Then subjects will receive weekly~     blister packs of medication and attend clinic thrice weekly during weeks 2-6. During weeks~     7-8, subjects no longer take disulfiram, are followed for two weeks, then referred to~     treatment elsewhere, if desired. Urine samples will be obtained and a disulfiram side-effects~     checklist will be completed thrice-weekly. Self-reported drug use, craving and mood ratings~     will be completed weekly. All subjects undergo cognitive behavioral therapy. Adjunctive~     contingency management procedures will be utilized to enhance retention. The primary outcomes~     of interest include retention, side-effects, and drug use. Our hypothesis is that disulfiram~     will be well tolerated in this population.~   "
216084|NCT00731120|"~     The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg~     vortioxetine, once daily (QD), in adults with generalized anxiety disorder.~   "
216085|NCT00731107|"~     The method most commonly used to gain entry to the abdomen in laparoscopic surgery (minimally~     invasive surgery) amongst gynecologists is the Veress Needle. This needle is inserted,~     usually near the belly button, before adding gas to the abdomen. With a pressurised abdomen a~     sharp trocar is then inserted to hold the operating telescope.~      The XCEL bladeless trocar is another method of inserting the operating telescope whereby you~     don't need to first introduce gas before the trocar. This trocar is widely used in~     laparoscopic surgery but it is uncommon to the field of gynecology.~      This study will compare the two methods with regard to:~        1. Time taken to enter the abdomen~        2. The number of attempts taken to enter the abdomen~        3. The impact of the time taken to enter compared to the whole operating time~        4. The happiness that the surgeon has entered the abdomen before adding gas, on a scale of~          1 to 5.~      Patients will be recruited into the trial through the Monash Medical Centre Gynecology~     department and the Mercy Hospital for Women Gynecology department. Patients that are having~     laparoscopic surgery and would usually have a Veress Needle entry are suitable for this~     trial. A patient information sheet will be provided and written consent will then be~     obtained. Patients who give written consent will be randomised into one of two arms of the~     trial, either the control (Veress Needle) or the XCEL bladeless trocar arm.~      Information will be entered on a proforma by a researcher for each patient during their~     operation. All patient information will be strictly confidential and only be available to~     researchers directly involved in the study.~      Surgeons operating as part of the project are the consultants and fellow of the gynecology~     department of Monash Medical Centre and Mercy Hospital for Women and are competent in both~     techniques.~      200 women will be recruited over a one year period and the data will then be analysed with~     the help of a statistician.~   "
216086|NCT00731094|"~     The purpose of the study was to examine the effectiveness of an expert-system, print-based~     physical activity (PA) intervention delivered to Veterans receiving primary care at the VA~     Pittsburgh Healthcare System (VAPHS).~   "
216087|NCT00731081|"~     To describe severe late onset patients with pompe disease receiving Myozyme®~   "
216088|NCT00731068|"~     To review the influence of patient derived PRGF on the healing process of Achilles tendon~     after a surgical correction of a complete tear.~   "
216089|NCT00731055|"~     The investigators hypothesize that varenicline will dose dependently attenuate the subjective~     effects of cigarettes after a period of abstinence. Also, treatment with varenicline will~     dose dependently weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize~     that treatment with varenicline will dose dependently decrease cigarette self-administration~     in the model proposed.~   "
216090|NCT00731042|"~     Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy~     volunteers.~   "
216091|NCT00731029|"~     This is a comparative vaccination study of the reactogenicity and immunogenicity of a~     thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of~     Influsplit SSW® 2002/2003 in individuals over 18 years.~   "
216092|NCT00731016|"~     We suggest treating the Hutchinson-Gilford Progeria Syndrome by two molecules (zoledronic~     acid and pravastatin).The therapeutic approach which we propose has for objectives to reduce,~     to prevent or to delay the gravest infringements of the disease, to prolong the life of the~     children, and in a more general way, aim at improving their living conditions.~   "
216093|NCT00731003|"~     Serotonin, 5-hydroxytryptamin (5-HT), plays an important role in regulating the~     gastrointestinal functions. In this study we will modulate the serotonin system with acute~     tryptophan depletion (ATD) and administration of 5-hydroxytryptophan (5-HTP). ATD is based on~     ingestion of an amino acid drink devoid of the precursor of serotonin and hence caused a~     decreased serotonin level. 5-hydroxy-tryptophan is the direct precursor of serotonin and its~     administration, an increased serotonin level is expected. During these interventions, gut~     permeability and visceral sensitivity will be measured in healthy individuals and patients~     with irritable bowel syndrome, which is characterized by altered permeability and visceral~     hypersensitivity.~   "
216094|NCT00730990|"~     The primary purpose of this study is to assess central receptor occupancy of PF 03654746 at~     the H3 receptor after a single oral dose of PF 03654746.~   "
216095|NCT00730977|"~     A novel dry powder inhaler device will be used to administer mannitol to healthy subjects and~     subjects with bronchiectasis in single doses higher than previously given.The main objective~     is to assess tolerability of these doses using the new device.~   "
216096|NCT00730964|"~     This prospective surveillance trial will gather safety information for Optison when it is~     used in routine practice.~   "
216097|NCT00730951|"~     While the use of herbals is increasing considerably, their efficacy and safety in the humans~     remains largely unknown. This surge in demand prompts a call for its evaluation. Preliminary~     data demonstrates that KRG can affect vascular function and our research group has previously~     shown that Korean Red Ginseng (KRG) can lower blood pressure (BP) in hypertensive~     individuals. However, it is unknown which dose is the most effective in producing a desired~     effect. To address this issue, we will test escalating doses of a single Korean red ginseng~     batch of 0.5g, 1g 3g and 6g on BP in patients with hypertension to determine the most~     efficacious dose. The most promising dose will be extracted and will advance to next level to~     be tested again on BP control. The findings of the study may result in better ginseng~     standardization.~   "
216098|NCT00730938|"~     The study investigates whether placing an antibiotic inside the eye at the end of cataract~     surgery in children will reduce the amount of fibrin formation (fibrin formation can block~     the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level~     infection and could be prevented by the antibiotic.~   "
216099|NCT00730925|"~     The primary objective of this open-label, single arm Phase II trial is to explore the~     efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the~     RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour~     activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with~     mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no~     EGFR mutations.~   "
216100|NCT00730912|"~     This is a post marketing study to confirm the appropriate dose of loratadine in children by~     obtaining drug concentration data at multiple time points per child and adult patient, after~     the patient receives repeated administrations of the approved dose of loratadine.~   "
216101|NCT00730899|"~     The purpose of this study is to determine whether polymorphisms in G protein subunits, namely~     Galphas and Galphaq, are associated with altered cardiac performance in heart failure~     patients.~   "
216102|NCT00730886|"~     The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000~     system for enhancement of fertility in women with non-hysteroscopically resectable uterine~     fibroids, who are diagnosed with unexplained infertility.~      Uterine fibroids are fairly common in women of child-bearing age. An evidence based review~     supported removing fibroids that distort the uterine cavity to increase pregnancy rates and~     decrease the rates of miscarriage. Some fibroids can be removed hysteroscopically which is~     minimally invasive, with low morbidity. However, removal of fibroids within the uterine wall~     require more invasive surgical procedures (e.g., myomectomy), with increasing morbidity risks~     including, but not limited to, infection, blood loss and postoperative uterine adhesions.~      ExAblate is approved by FDA for the treatment of uterine fibroids; however, its use in~     patients seeking pregnancy is considered experimental. Accumulated evidence suggests there~     are no significant complications from the procedure in women seeking pregnancy as with~     existing fibroid therapies; however, these data are based on a small number of patients. This~     study will evaluate fertility enhancement following ExAblate treatment or myomectomy, in~     women with unexplained infertility and who have non-hysteroscopically resectable uterine~     fibroids.~   "
216103|NCT00730873|"~     Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities~     in liver enzymes can improve following continuous positive airway pressure in patients with~     obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes.~     We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver~     changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this~     reduction can be evident using computerized tomography~   "
216104|NCT00730860|"~     A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by~     RFA associated with postoperative TACE.~   "
216105|NCT00730847|"~     The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals'~     Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per~     the Bureau of Food and Drugs Directive of Philippines.~   "
216106|NCT00730834|"~     Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with~     clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared~     Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion~     criteria and they are also required to pay for the all costs of the treatment. Subjects will~     be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient~     questionnaires (subjects must have access to a computer and internet in order to complete on~     line questionnaires).~   "
216107|NCT00730821|"~     The primary objective of this trial is to determine the MTD of the combination of BIBW~     2992/BIBF 1120 therapy administered concomitantly in a 28-day cycle schedule.~      Secondary objectives are the collection of antitumor efficacy data, the determination of~     pharmacokinetic parameters of BIBF 1120 and BIBW 2992, and if data allow the determination of~     the pharmacokinetic influence of BIBW 2992 on BIBF 1120 and vice versa.~   "
216108|NCT00730808|"~     The aim of this pilot study is to investigate effectiveness, tolerability and safety of an~     oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low~     anterior resection.~   "
216110|NCT00730782|"~     The objective of this study was to evaluate the safety of a candidate malaria vaccine~     (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50~     μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults~     not previously exposed to the parasite Plasmodium falciparum.~   "
216111|NCT00730769|"~     The objectives of this study were:~        1. To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV~          infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days~          of treatment.~        2. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with~          respect to ganciclovir given intravenously (i.v.).~        3. Evaluate the security of this treatment with valganciclovir.~   "
216112|NCT00730756|"~     The purpose of this pilot study is to compare the effects (effectiveness and safety)of an~     intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]) with a placebo nasal spray~     for the treatment of irritant (non-allergic) rhinitis.~   "
216113|NCT00730743|"~     This study aims to evaluate whether applying inflow vascular occlusion in modern liver~     resection is associated with better clinical outcome.~      Eligible patients are randomly assigned to the two surgical techniques: with or without the~     application of inflow vascular occlusion.~      Patients outcome including liver function recovery, operative time and blood loss are~     compared.~   "
216114|NCT00730730|"~     The purpose of this study is to show if a new delivery system with a modified stent is safe~     in treating occluded iliac arteries in patients with peripheral vascular disease. The~     modified Complete SE delivery system is hypothesized to assist physicians with more accurate~     stent placement reducing the likelihood of stent 'jumping' seen with the use of many~     self-expanding stent systems.~   "
216115|NCT00730717|"~     The purpose of this study is to determine the safety and efficacy of Humira in the treatment~     of pyoderma gangrenosum.~   "
216116|NCT00730704|"~     Worldwide cervical cancer remains a major cause mortality among women. It is estimated that~     each year over 490,000 women are diagnosed with cervical cancer and more than 270,000 die~     from the disease. While the implementation of widespread screening programs has reduced the~     burden of cervical cancer, a large percentage of the population still remains unscreened or~     is underscreened. It is now recognized that human papillomavirus (HPV) is a necessary~     precursor for the development of cervical cancer. The first vaccine to prevent HPV was~     recently approved by the Food and Drug Administration and is now available at doctors~     offices. Despite the availability of a safe and effective means for the prevention of~     cervical cancer, widespread implementation of vaccination has been extremely difficult.~     Several potential issues have limited the development of widespread HPV vaccination programs,~     including cultural and religious beliefs, and limitations in the practicality of~     administering the vaccine. The overall goals of our work are to improve access to preventive~     strategies for cervical cancer. In this proposal we will examine the strategy of HPV~     vaccination for women who have just given birth. We believe that HPV vaccination of these~     women will be associated with a high level of patient satisfaction and acceptance. If~     successful, this strategy could play a major role in advancing the acceptance and~     implementation of HPV vaccination in the United States.~   "
216117|NCT00730691|"~     The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily~     (QD), in adults with generalized anxiety disorder.~   "
216118|NCT00730678|"~     To investigate whether genetic polymorphisms in genes encoding proteins involved in the~     metabolism or effects of drugs or environmental agents influence the disposition or effects~     of these xenobiotic substrates. To investigate the nature of heritability and the genetic~     basis of pharmacogenetic traits by studying family members of individuals with specific~     genotypes.~   "
216119|NCT00730665|"~     To understand the dose-response characteristics of PF-00885706 for efficacy in terms of~     symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump~     inhibitor [PPI] treatment), in subjects with gastro-esophageal reflux (GERD) who have~     inadequate relief with PPIs.~   "
216120|NCT00730652|"~     To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle~     cell lymphoma.~   "
216121|NCT00730639|"~     The purpose of this study is to determine the safety and effectiveness of MDX-1106 in~     patients with certain types of cancer. Another purpose is to determine how MDX-1106 is~     absorbed and distributed within the body, and how it's eventually eliminated.~   "
216122|NCT00730626|"~     The purpose of this study is to determine the dose-response effect of a yogurt containing a~     combination of bifidobacterium Lactis (BB-12) and Lactobacillus Acidophilus (LA-5) and green~     tea extract on markers of the immune system and gut health in healthy subjects. We~     hypothesize that the response of the immune function will be dose-dependent of the probiotics~     found in the fermented yogurt.~   "
216123|NCT00730613|"~     RATIONALE: Cellular adoptive immunotherapy may stimulate the immune system in different ways~     and stop cancer cells from growing.~      PURPOSE: This clinical trial is studying the side effects of cellular adoptive immunotherapy~     using genetically modified T-lymphocytes and to see how well it works in treating patients~     with recurrent or refractory high-grade malignant glioma.~   "
216124|NCT00730600|"~     The purpose of this study is to explore the skeletal effect of Thai traditional massage by~     examining the changes in biochemical markers of bone turnover immediately after the massage.~   "
216125|NCT00730587|"~     The InfantPod study is a cross-sectional study designed to determine how practical and~     precise a body composition method is for measuring body fat and lean tissue in infants and~     children ages 5 months to 3 years.~   "
216126|NCT00730574|"~     The purpose of this study is to determine the commonness of the C677T mutation in the MTHFR~     gene in subjects with B12 deficiency. Also, we'd like to investigate the effect of B12~     deficiency combined with the C677T mutation on endothelial function.~   "
216127|NCT00730561|"~     Several pathophysiological theories have been proposed for the development of diabetic~     chronic complications. In recent years, the use of stem cells (totipotential, hematopoietic~     or endothelial lineages) has been reported as an adjunctive modality of treatment for~     ischemia models in animals and humans. Nevertheless, there are no reports in the use of stem~     cells for the treatment of human sensorimotor peripheral diabetic neuropathy. We performed~     this study to evaluate the effect of autologous hematopoietic CD34+ cell transplantation on~     nerve conduction velocity in patients with type 2 diabetes mellitus.~   "
216128|NCT00730548|"~     This pilot study is to prospectively evaluate the benefit of clinicians being able to access~     ICD device information in a timelier manner and treat fluid overload with a pre-defined~     pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in~     Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic~     OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician~     (standard arm).~   "
216129|NCT00730535|"~     This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB~     symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of~     treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.~      Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment~     response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to~     1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be~     evaluated for changes in OAB symptoms and retreatment rate will be assessed.~   "
216130|NCT00730522|"~     The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated~     subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of~     the study's Treatment Phase (Weeks 11 and 12).~   "
216131|NCT00730509|"~     The purpose of this study is to determine whether 5 - methyltetrahydrofolate and vitamin B12~     supplementation can ameliorate cell plasma membrane features in pediatric patients with~     cystic fibrosis~   "
216132|NCT00730496|"~     Forty-five infertile women undergoing in vitro fertilization treatment were managed by~     uterine cavity injection of day 2 embryo culture supernatant before day 3 embryo transfer. No~     statistically significant differences were found in implantation and pregnancy rates when~     compared with control group.~   "
216133|NCT00730483|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Infusing doxorubicin beads into the liver, and blocking blood flow to the tumor, may keep~     doxorubicin near the tumor and kill more tumor cells.~      PURPOSE: This clinical trial is studying the side effects of doxorubicin beads and to see how~     well they work in treating patients with unresectable liver metastases from neuroendocrine~     tumors.~   "
216134|NCT00730470|"~     This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and~     pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3~     receptor, in patients with advanced solid tumors. Eligible patients will have disease that is~     refractory or resistant to standard treatments or for which no standard therapy exists. The~     study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part~     2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in~     patients with advanced solid tumors and will show initial evidence of anti-tumor activity.~   "
216135|NCT00730457|"~     Is VAX125 safe at doses ranging from 0.1 to 8 ug when delivered i.m. in a single dose regimen~     Is VAX125 able to induce a post-vaccination serum HAI antibody response in healthy adults~     against the influenza A virus H1 HA.~   "
216136|NCT00730444|"~     GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123~     Injection ([123I]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of~     primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an~     Expanded Access program to provide AdreView to pediatric medical centers and hospitals that~     treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of~     patients with known or suspected neuroblastoma for whom there is an appropriate clinical~     indication for [123I]mIBG imaging.~   "
216137|NCT00730431|"~     The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of~     IDX184 in humans. No formal hypotheses are to be tested in this study.~   "
216138|NCT00730418|"~     In this study, we investigate the changes of the expression of alpha adrenergic receptor in~     the prostate tissue during 2-yr medication period in the man with benign prostatic~     hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin~     (4mg, 8mg)~   "
216139|NCT00730405|"~     Phase 2 study to examine how the study drug works and its side effects in subjects with~     toenail fungus.~   "
216140|NCT00730392|"~     The investigators hypothesized that the administration of Etanercept to children newly~     diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study~     is to evaluate the feasibility and safety of Etanercept administration to pediatric patients~     recently diagnosed with type 1 DM.~   "
216141|NCT00730379|"~     This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in~     patients who have advanced cancer and to observe any anti-tumor activity in these patients.~   "
216142|NCT00730366|"~     Malaria in pregnancy contributes substantially to maternal anaemia and low birth weight:~     effective malaria control in pregnancy could avoid about 10,000 maternal and up to 200,000~     infant deaths every year. Intermittent preventive treatment with the drug~     sulfadoxine-pyrimethamine (IPTp-SP), administered at least twice during routine antenatal~     clinics, is recommended by the World Health Organization for areas of moderate to high~     malaria transmission, including Sub-Saharan Africa.~      Studies carried out in Kenya and Malawi before 2004 had showed that two doses of IPTp-SP~     significantly reduce maternal anaemia, placental malaria parasitaemia and low birth weight.~     However, in countries where this strategy had been introduced as part of national policy, the~     coverage of the target population has varied widely, with estimates of 33-93% for uptake of~     one dose and 24-68% for two doses, and no country had reached the goal of 80% of pregnant~     women receiving at least 2 doses of IPTp. New approaches designed to improve IPTp coverage~     were therefore urgently needed.~      This study was therefore set up in 2002, in order to evaluate the additional effect of a~     targeted promotional campaign on antenatal clinics utilization and on coverage and uptake of~     Intermittent preventive treatment with sulfadoxine-pyrimethamine in a rural health district~     in Burkina Faso; and to investigate the effectiveness of intermittent preventive treatment~     with the sulfadoxine-pyrimethamine compared with weekly chloroquine, in order to provide~     additional evidence to the Burkinabé Ministry of Health for an impending policy change.~   "
216581|NCT00724516|"~     The purpose of this study is to evaluate the functionality of a new breast compression paddle~     used in mammography for wire localization.~   "
249073|NCT00292370|"~     The purpose of this study is to compare the response of veterans with PTSD without an optimal~     response to paroxetine to quetiapine augmentation versus placebo.~   "
216143|NCT00730353|"~     Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and~     has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens.~     Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when~     combined with chemotherapy, as demonstrated with other regimens in similar settings. We~     believe that the combination of paclitaxel and sunitinib malate offer great promise in the~     treatment of advanced esophageal cancer.~   "
216144|NCT00730340|"~     This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae~     closure compared to without closure of the operative wound.~   "
216145|NCT00730327|"~     Safety and effectiveness of the BIB® System in conjunction with a behavior modification~     program compared to the behavior modification program alone for weight loss in obese~     subjects.~   "
216146|NCT00730314|"~     This is a clinical trial of bone marrow transplantation for patients with the diagnosis of a~     genetic disease of blood cells that do not have an HLA-matched sibling donor. Genetic~     diseases of blood cell include: Red blood cell defects e.g. hemoglobinopathies (sickle cell~     disease and thalassemia), Blackfan-Diamond anemia and congenital or chronic hemolytic~     anemias; White blood cells defects/immune deficiencies e.g. chronic granulomatous disease,~     Wiskott-Aldrich syndrome,Osteopetrosis, Kostmann's syndrome (congenital neutropenia),~     Hereditary Lymphohistiocytosis (HLH); Platelets defects e.g.Congenital amegakaryocytic~     thrombocytopenia; Metabolic/storage disorders e.g. leukodystrophies,mucopolysaccharidoses as~     Hurler disease;Stem cell defects e.g.reticular agenesis, among many other rare similar~     conditions.~      The study treatment plan uses a new transplant treatment regimen that aims to try to decrease~     the acute toxicities and complications associated with the standard treatment plans and to~     improve outcome~      The blood stem cells will be derived from either unrelated donor or unrelated umbilical cord~     blood.~   "
216147|NCT00730301|"~     The purpose of this study is to assess the efficacy of a new treatment algorithm for~     bronchoscopic lung volume reduction (BLVR) in patients with emphysema based on the~     information of emphysema heterogeneity, destruction score, and fissure analysis.~   "
216148|NCT00730288|"~     To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the~     ChimeriVax™ dengue tetravalent vaccine~      Primary Objectives:~        -  To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.~        -  To describe the immune response against dengue before and after one injection of~          ChimeriVax™ dengue tetravalent vaccine~   "
216149|NCT00730275|"~     This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to~     17 year old diabetic patients.~   "
216150|NCT00730262|"~     The objective of this study is to assess the efficacy and safety of TLN-4601 used to treat~     patients with Glioblastoma Multiforme(GBM) that recur/progress after receiving first line~     systemic therapy post surgery/radiotherapy.~   "
216151|NCT00730249|"~     Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD,~     compared with a placebo~   "
216152|NCT00730236|"~     The goal of this trial is to study the effects of AEGR-733 on LDL cholesterol, other lipids~     as well as measures of safety over the long-term.~   "
216153|NCT00730223|"~     To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug~     levels and central nervous system side affects in people who take nevirapine or efavirenz.~   "
216154|NCT00730210|"~     The aim of the study is to assess whether PTH (1-84) therapy posses advantages compared to~     conventional treatment in patients with hypoparathyroidism on muscle function, quality of~     life, calcium homeostasis, bone metabolism, and body composition.~   "
216155|NCT00730197|"~     The objective of this study was to investigate the bioequivalence of nisoldipine~     extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release~     40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg~     tablet) dose administration in healthy adult subjects under fasting conditions.~   "
216156|NCT00730184|"~     The purpose of this study is to examine whether adding the basic salt potassium bicarbonate~     to the diet will have a positive effect on how dietary protein affects your bone and muscle.~   "
216157|NCT00730171|"~     The objective of this study is to assess the long-term safety of linaclotide administered to~     patients with chronic constipation (CC) or irritable bowel syndrome with constipation~     (IBS-C).~   "
216158|NCT00730158|"~     KD018 is an oral form of a spray dried aqueous extract composed of four main herbs, which~     have been used in the Orient for nearly 2000 years for a variety of GI symptoms including~     diarrhea and nausea/vomiting. Extensive pre-clinical research has been done with Chinese~     herbal medicine, and studies have documented significant anticancer activity in combination~     with various cytotoxic agents including Irinotecan, which is a semi-synthetic derivative of~     the natural alkaloid camptothecin and belongs to the class of topoisomerase I inhibitors. The~     proposed plan will investigate the mechanism and efficacy of Chinese herbal medicine as an~     adjunct to chemotherapy in treatment of patients with metastatic colorectal cancer. Our~     rationale for the therapeutic use of KD018 is its potential activity in reducing~     chemotherapy-induced toxicity, especially diarrhea.~   "
216159|NCT00730145|"~     1. Quantify how much PD-0332334 is removed from the blood with hemodialysis~        2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving~          regular hemodialysis treatments.~        3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects~          receiving hemodialysis.~   "
216160|NCT00730132|"~     This study is being performed to evaluate what variants of lipid-lowering therapy are used in~     Russian clinical practice in coronary heart disease (CHD) patients with hypercholesterolemia~     in whom the initial statin therapy did not achieve low density lipoprotein-cholesterol~     (LDL-C) goals. Additionally, the efficacy and safety of all variants of modified~     lipid-lowering therapy are to be evaluated.~   "
216161|NCT00730119|"~     This investigation is a multi-center study that will demonstrate that the GE Monitor meets~     equivalency and/or accuracy and/or performance criteria. This investigation will compare the~     test device(s) to itself, or one of the reference parameters, or a combination of parameters,~     including NIBP, temperature, SpO2, respirations, and ECG.~   "
216612|NCT00724113|"~     The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus~     intensive mobilisation in shoulder capsulitis.~   "
216162|NCT00730106|"~     Gastroesophageal reflux disease (GERD) is diagnosed on the basis of characteristic reflux~     symptoms (i.e. troublesome heartburn and/or acid regurgitation). Empirical therapy without~     diagnostic endoscopy is suggested for those GERD patients presenting without alarm symptoms~     in Western countries. Whether such treating instead of testing strategy should be applied~     in Asia, an area with higher prevalence of Helicobacter pylori and gastric cancer, remains~     uninvestigated.~   "
216163|NCT00730093|"~     During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through~     increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is~     crucial for the normal development af foetus during pregnancy.~      In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the~     woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation~     for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test,~     CobaSorb.~   "
216164|NCT00730080|"~     Investigators at Washington University will examine the effects of sapropterin (Kuvan) on~     brain and cognition in individuals with phenylketonuria (PKU) using neuropsychological and~     neuroimaging procedures. Sapropterin is a medication developed by BioMarin Pharmaceutical~     Inc. that is approved by the FDA for treatment of patients with PKU to reduce phenylalanine~     (Phe) levels. Patients beginning treatment with sapropterin as standard clinical care will be~     enrolled in the study. As a first step, patients with PKU will receive baseline~     neuropsychological and neuroimaging evaluations 1 day prior to beginning treatment with~     sapropterin. Screening for response to sapropterin will occur over 4 weeks. At the end of 4~     weeks, response to sapropterin will be reviewed. Patients with a reduction of ≥ 20% in blood~     Phe (i.e., responders) will receive follow-up neuropsychological and neuroimaging evaluations~     after 6 months of treatment with sapropterin. Patients (both responders and nonresponders)~     will receive long-term follow-up neuropsychological and neuroimaging evaluations 3 to 5 years~     after initial enrollment in the study.~      The focus of neuropsychological testing will be executive abilities, as these abilities are~     particularly susceptible to disruption in individuals with PKU. We hypothesize that~     improvements in these abilities will occur following treatment with sapropterin. For~     neuroimaging assessments, structural magnetic resonance imaging (MRI) will permit evaluation~     of changes in the structure and volume of the gray and white matter of the brain, whereas~     diffusion tensor imaging (DTI) will permit evaluation of microstructural white matter~     integrity.~   "
216165|NCT00730067|"~     Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in~     the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether~     treatment of the increased pulmonary blood pressure betters the patients symptoms.~      In this study 32 patients with increased pulmonary blood pressure due to COPD will be~     randomized to 3 months treatment with placebo or sildenafil, which is known to lower the~     pulmonary blood pressure in other types of pulmonary hypertension.~      Our hypothesis is that treatment with sildenafil in these patients will improve the~     functional capacity measured by the distance walked in 6 minutes and life quality.~   "
216166|NCT00730054|"~     The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to~     relief acute main in an experimental human pain model. Of interest is also the effect of the~     combination on respiration, sedation and cognitive behavior.~   "
216167|NCT00730041|"~     The study will be done for the following purposes:~        -  to see if Pillar implants in combination with CPAP therapy can help people with their~          OSA by decreasing the CPAP pressures~        -  to find out if receiving Pillar implants will increase CPAP use~   "
216168|NCT00730028|"~     The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight~     bacteria, [clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)] and wound care~     for the outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in~     children and adults. The study will occur in areas where community associated~     methicillin-resistant Staphylococcus (S.) aureus are common. S. aureus is a type of bacteria.~     A total of 1310 volunteers, greater than or equal to 6 months of age and adults 85 years or~     younger, non-immunocompromised, with uSSTIs (in particular abscess and/or cellulitis) will be~     enrolled in this study. Subjects will be treated with one of the following: CLINDA, TMP-SMX,~     or placebo (contains no medication). Volunteers will be grouped based on the presence of~     cellulitis or abscess, whether the abscess can be surgically drained, and its size. The~     subject participation duration for this study is about 6 weeks.~   "
216169|NCT00730015|"~     The objective of this trial is to determine the efficacy and safety of linaclotide~     administered to patients with chronic constipation (CC). The primary efficacy parameter is~     the percentage of patients in each dosing group that meet the protocol definition for~     Complete Spontaneous Bowel Movement (CSBM) Overall Responder.~   "
216170|NCT00730002|"~     The purpose of this study is to determine if three functional Magnetic Resonance brain~     imaging techniques: Magnetic Resonance Spectroscopy(MRS),Magnetic Resonance perfusion, and~     Diffusion Tensor Imaging(DTI) can detect brain alterations distinctive for neuropsychiatric~     systemic lupus erythematosus (NPSLE)and systemic lupus erythematosus(SLE).~   "
216171|NCT00729989|"~     The stomach of the newborn baby is often emptied soon after birth to prevent breathing~     problems (respiratory distress). Babies born with meconium-stained amniotic fluid and those~     with increased secretions associated with birth by C-section are thought to be at particular~     risk of breathing problems during the first minutes of life. Emptying the stomach by sucking~     out all its contents (gastric suctioning) is alleged to lessen the risk of aspiration and~     improve respiratory distress. This study will evaluate the usefulness of gastric suctioning~     during neonatal resuscitation.~   "
216172|NCT00729976|"~     Fever is one of the most common symptoms in pediatrics and one of the most common reasons for~     visits in pediatricians' office and pediatric emergency departments. Many parents consider~     fever to be the most terrifying symptom.~      Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen~     was available only in tablets suspension and as a liquid gel. All these dosage form are~     administered orally. Rectal suppositories are often essential for treating febrile children~     who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare~     the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.~   "
216613|NCT00724100|"~     The purpose of this study is to determine the maximum tolerated dose of ALB 109564(a), a~     novel tubulin inhibitor, and to assess safety, pharmacokinetics, and anti-tumor activity in~     subjects with advanced solid tumors.~   "
216173|NCT00729963|"~     The primary objective of this study is to observe if Sibutramine is effective in improving~     the symptoms and signs of sleep apnea in obese patients. The secondary objectives are to~     document the effects of Sibutramine on heart rate variability and 24-h arterial pressure~     values. We hypothesized that sibutramine will improve sleep disordered breathing, cardiac~     autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea~     (OSA).~   "
216174|NCT00729950|"~     This is a Phase I, open-label, multicenter, pharmacokinetic study of MDX-010 in up to 90~     evaluable subjects with surgically unresectable malignant melanoma.~   "
216175|NCT00729937|"~     The purpose of this study is to determine the optimal outpatient treatment strategy of~     uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the~     prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA)~     is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of~     SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive~     Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication),~     clindamycin, or cephalexin or some combination of these. The study population will include~     2,235 volunteers, children 13 years of age and over and adults presenting to 5 large urban~     Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected~     wound, and cellulitis will start on the day of enrollment. Participants may be involved in~     study related procedures for about 9 weeks.~   "
216176|NCT00729924|"~     This study is being done to find out how much of the drug raltegravir (RGV) gets into~     cerebrospinal fluid (CSF), compared to how much get into the blood and to find out if normal~     changes in a certain gene in your body affects how much RGV gets into the CSF.~   "
216177|NCT00729911|"~     1. To determine if catheter-based atrial fibrillation (AF) ablation is superior to~          Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with~          an impaired left ventricular function.~        2. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic~          persistent or permanent AF and impaired LV function in terms of recurrence of AF,~          quality of life, 6-minute walk distance, EF and total number of hospitalizations.~   "
216178|NCT00729898|"~     This study is conducted in Europe. The study aims to observe the incidence of serious adverse~     drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.~   "
216179|NCT00729885|"~     Benign Paroxysmal Positional Vertigo (BPPV) is one of the most common causes of vertigo and~     the most common vestibular disorder of the inner ear. BPPV is the result of small~     free-floating particles (canaliths) in the posterior semicircular canals where they aggravate~     the sensory apparatus and induce sudden and severe attacks of vertigo when the head is turned~     into certain positions.~      The treatment of BPPV was revolutionized by the introduction of the Epley maneuver, a~     sequence of head movements that use gravity to reposition the canaliths within the inner ear.~     The Epley maneuver provides prompt relief from vertigo in approximately 80% of patients.~      The innovation, the Vertigone goggle, provides both physician and patient with visual~     feedback to guide them through an accurate Epley maneuver. This changes the current treatment~     paradigm for BPPV, greatly increasing the availability of the maneuver to non-specialist~     physicians, nurse practitioners, physician's assistants and physical therapists. The device~     is designed so that the patient with recurrent vertigo can use the goggle to treat BPPV at~     home. The goggle is currently a pre-market prototype.~      The hypothesis for the study is that accuracy in the performance of the Epley maneuver~     correlates with improved clinical resolution of vertigo in BPPV patients. If the hypothesis~     is true, then there is a clear case for the utility of the visual feedback provided by the~     VertiGONE goggle in performing the maneuver.~   "
216180|NCT00729872|"~     The purpose of this study is to verify the safety and tolerability of AG011 (genetically~     modified L. lactis that has been engineered to secrete human Interleukin-10), and to~     determine whether AG011 can successfully treat the symptoms of moderately active Ulcerative~     Colitis (UC).~   "
216181|NCT00729859|"~     The original purpose of this research study was to understand the effects of testosterone (T)~     and estrogen on stem cells in the blood. The knowledge would be used to help understand the~     effects of T and estrogen on cardiovascular (heart and blood vessel) disease, and to help in~     the development of a safe male hormonal contraceptive.~      The effect of androgens on the number of circulating endothelial progenitor (CEP) cells would~     best be observed in group 1 (placebo). Upon observation of group 1 under original protocol,~     changes in CEP cells were not significant but there were changes in markers of inflammation,~     lipids, and HDL protein composition. A modification to the protocol and title were made to~     reflect this for groups 2 and 3: Hormonal regulation of HDL-C in Men.~   "
216182|NCT00729846|"~     To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and~     the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic~     therapy at standard or reduced fluence level in patients with subfoveal CNV due to~     age-related macular degeneration.~   "
216183|NCT00729833|"~     The study is being conducted to determine the maximum tolerated dose, overall safety and~     tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in~     combination with advanced solid tumors.~   "
216184|NCT00729820|"~     Recently, a lot of evidence for a relation between measures of cognitive performance and~     personality characteristics has been collected. The use of computer based latency measures is~     often used to study mental processes in cognitive, as well as, in personality research On the~     basis of these relationships we can ask a question that relates to the practical usefulness~     (validity) of processing speed, accuracy of performance and personality measures in~     predicting impulsive behavior.~   "
216185|NCT00729807|"~     RATIONALE: Drugs used in chemotherapy, such as pentamidine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well pentamidine works in treating patients with~     relapsed or refractory melanoma.~   "
216256|NCT00728858|"~     Nifedipine and barnidipine act as calcium channel blockers, and are widely prescribed for~     pressure control of prehypertension and stage 1 hypertension.~      CYP3A4 is responsible for the metabolism of nifedipine and nifedipine, while the contribution~     of CYP3A5 remains ambiguous. This study is aimed to analyze the association between~     antihypertensive effects of nifedipine as well as barnidipine and single nucleotide~     polymorphisms of CYP3A4, CYP3A5 and calcium channels.~   "
216186|NCT00729794|"~     The simultaneous activation of adrenergic and vasopressin receptors, in conjunction with a~     potential steroid-mediated enhancement of the vascular reactivity to epinephrine may have~     beneficial effects in patients with cardiac arrest. This hypothesis is supported by the~     single-center results of NCT 00411879. The investigators intend to either refute or provide~     definitive evidence supporting this hypothesis (and its generalizability) by conducting the~     present multicenter, randomized, controlled clinical trial of in hospital cardiac arrest.~   "
216187|NCT00729781|"~     The purpose of this study is to research a polyester polyethylene terephthalate (PET) implant~     for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes~     narrowness and weakness in the nostril which results in nasal obstruction. Implants will be~     placed in the affected nostril(s). The implants are intended to restore the shape and~     stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated~     with nasal obstruction.~   "
216188|NCT00729768|"~     This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to~     evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both~     are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction~     therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A~     total of 200 subjects undergoing either living or cadaveric renal transplantation will be~     randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF +~     corticosteroids.~   "
216189|NCT00729755|"~     Given 1) the established safety with short-term or long-term supplementation of Cr, 2) its~     potential usefulness in improving brain energy metabolism, 3) the reported abnormality in~     brain energy metabolism in MDD subjects, and 4) plausible association between depression and~     inflammatory mediators, we hypothesize that oral Cr augmentation will help reduce symptoms in~     MDD patients as well as normalize a deficit in brain energy metabolism and that improvement~     of MDD and brain energy metabolism will be correlated with inflammatory mediators changes.~      In this study, we plan to conduct an randomized, double-blind, placebo-controlled~     augmentation study with creatine in addition to escitalopram. We will assess the efficacy and~     safety of the Cr augmentation and evaluate changes relevant to brain energy metabolism and~     inflammatory mediators.~   "
216190|NCT00729742|"~     This study will use imaging to look at tumor response to erlotinib (Part I) and the~     combination of erlotinib and dalotuzumab (Part II).~   "
216191|NCT00729729|"~     A comparative bioavailability study of PCA slow release versus immediate release~     formulations, after a single dose to fasting healthy subjects.~   "
216192|NCT00729716|"~     BioCart™II is a novel scaffold seeded with autologous chondrocytes to be used to repair~     cartilage lesions of the knee. This study is designed to compare the efficacy and safety of~     BioCart™II treatment compared to microfracture which is the classical method of treatment.~   "
216193|NCT00729703|"~     This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular~     stimulation in combination with advanced dual chamber detection with slow VT management on~     the clinical outcome for hospitalization and mortality and inadequate therapy in medically~     stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do~     not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It~     compares a new pacing mode avoiding ventricular stimulation when not needed combined with~     dual chamber detection with a pure ventricular back up pacing and single chamber detection~     criteria with pure ventricular back up pacing. Therapies are compared in a prospective,~     randomized, single-blinded, parallel trial with a 24-month randomized treatment period.~     Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the~     study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.~   "
216194|NCT00729690|"~     This study involves research. Pregabalin is a Food and Drug Administration (FDA) medication~     approved in the United States for the treatment of nerve pain related to diabetes and~     post-herpetic neuralgia shingles, and for seizures in adults. The purpose of this research~     is to study the effect of oral Pregabalin on spinal neurotransmitters in subjects undergoing~     Total Knee Replacement Surgery (TKA). TKA is associated with considerable postoperative pain~     which if unrelieved may result in prolonged hospital stay, inability to participate in~     rehabilitation programs, poor outcomes, and greater use of health-care resources. This study~     examines the effect of pregabalin administered for TKA on pain-related neurotransmitter~     concentrations.~   "
216195|NCT00729677|"~     RATIONALE: Learning how often patients experience nausea and vomiting after receiving~     anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better~     treatment and improve patients' quality of life.~      PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with~     colorectal cancer receiving standard anti-vomiting medicine during the first course of~     chemotherapy.~   "
216196|NCT00729664|"~     Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of~     PD-L1 receptor occupancy in peripheral blood has been added.~   "
216197|NCT00729651|"~     To demonstrate the efficacy/safety of Fosamax Plus D~   "
216198|NCT00729638|"~     The purpose of this research study is to determine the highest dose of lenalidomide and~     RAD001 that can be given without causing too many serious side effects. Another goal of this~     research study is to look at how the participants cancer may respond to the study treatment.~     Additionally, we wish to learn more about how the body breaks down and gets rid of the study~     drugs. We will also try to find substances in the blood (biomarkers) that may help predict~     how myeloma will respond to study treatment.~   "
216210|NCT00729482|"~     This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free~     survival rate (primary end-point) and response rate, toxicity, and overall survival~     (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer.~      Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer~     who failed previous first-line standard treatment with fluoropyrimidine and platinum-based~     chemotherapy.~      Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted~     according to the observed clinical toxicities. Treatment will be continued until disease~     progression or patient's intolerability to the study drug.~      Total of 54 patients will be enrolled to decide whether the proportion of patients who are~     free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater~     than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate,~     10%.~   "
216199|NCT00729625|"~     Many patients who have sustained strokes are unable to effectively use their hemiparetic~     upper extremity. Limited mobility in the performance of daily activities, such as eating or~     dressing, adversely affects their quality of life and compromises independence.~     Rehabilitation techniques engaging the hemiparetic limb in repetitive task practice (RTP) may~     improve upper extremity function and quality of life in patients with stroke, but costs limit~     the number of patients that can utilize this type of therapy. Advances in microprocessor~     design and function make the use of an assistive device as an adjunct to RTP plausible. An~     innovative assistive repetitive motion (ARM) device using an air muscle has been developed~     specifically for the rehabilitation of the hemiparetic upper extremity. The primary aim of~     the proposed study is to collect pilot data to estimate the clinical effectiveness of using~     the ARM device in conjunction with RTP to improve upper extremity motor function and the~     quality of life of patients with stroke. Twenty sub-acute (3 to 9 mos. post-stoke) patients~     will be randomized to a RTP only or ARM + RTP group. The RTP group will receive 15 days (4~     hours per day) of intensive one-on-one RTP therapy. The ARM + RTP group will use the ARM~     device for 2 hours per day and receive 2 hours of intensive RTP per day for 15 days. Clinical~     motor function and quality of life measures will be taken before and after the interventions~     and two months later. We hypothesize that the ARM + RTP group will exhibit greater~     improvements in motor function and quality of life measures than the RTP only group.~   "
216200|NCT00729612|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle~     formulation given together with carboplatin works in treating patients with stage IIIB, stage~     IV, or recurrent non-small cell lung cancer.~   "
216201|NCT00729599|"~     To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to~     odontological usage.~   "
216202|NCT00729586|"~     This randomized phase II trial studies how well temsirolimus with or without megestrol~     acetate and tamoxifen citrate works in treating patients with endometrial cancer that has~     spread to other places in the body and usually cannot be cured or controlled with treatment,~     has returned after a period of improvement, or is persistent. Temsirolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can~     cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate and~     tamoxifen citrate may fight endometrial cancer by blocking the use of estrogen by the tumor~     cells. It is not yet known whether temsirolimus is more effective when given alone or~     together with megestrol acetate and tamoxifen citrate in treating endometrial cancer.~   "
216203|NCT00729573|"~     The MTN-003 HIV prevention study include the use of microbicides, substances that kill~     microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil~     fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to~     determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on~     bone mineral density (BMD).~   "
216204|NCT00729560|"~     Polycystic Ovary Syndrome (PCOS) is the major cause of infertility in the United States. Many~     women with PCOS demonstrate insulin resistance and a compensatory hyperinsulinemia.This is~     due to both an intrinsic form of insulin resistance unique to PCOS and, in many cases,~     acquired insulin resistance due to obesity. The importance of this observation lies in the~     fact that hyperinsulinemia appears to play an important pathogenetic role in the~     hyperandrogenism and anovulation of both obese and lean women with PCOS.~   "
216205|NCT00729547|"~     The investigators examined the therapeutic efficacy of neurofeedback in depression subjects.~     The investigators hypothesize that 5 weeks neurofeedback training will be able to alleviate~     depressive symptoms.~   "
216206|NCT00729534|"~     This study will examine how research volunteers experience their participation in studies in~     order to develop surveys to be used by research centers trying to improve the experience of~     their participants.~      People 18 years of age and older who have participated in an NIH research protocol within the~     past 2 years as someone with a medical condition under study may be eligible for this study.~      Eight participants will participate in a moderator facilitated focus group in a discussion~     about being in research studies. An observer audiotapes the discussion and takes written~     notes. The focus group discussion lasts about 1 to 1 (Omega) hours.~   "
216207|NCT00729521|"~     An important challenge for the field of injury prevention and control is the translation of~     research findings into effective community-based prevention programs and practices. The~     National Center for Injury Prevention and Control believes that dissemination research can~     overcome this challenge by providing insight into the structures and methods needed to~     translate injury control research into everyday practice. The proposed dissemination research~     study will rigorously assess whether the use of a facilitative system can successfully~     bridge the gap between injury prevention and control research and the implementation of~     evidence-driven, community-based programs, policies, and practices. The facilitative system~     links communities with academic partners to provide communities with the skills and resources~     needed to help facilitate the community health improvement process. The system identifies~     what assets are available within communities, as well as the skills and resources needed to~     work through the community health improvement process. The facilitative system will then~     provide technical assistance, best practices guides, and direct consultation in carrying out~     all phases of the community health improvement process. This information is designed to~     increase community capacity in community assessment, coalition development, accessing and~     interpreting local injury prevention data, searching and selecting evidence-based research,~     and program planning and evaluation. The study will use a randomized community trial design~     to evaluate fall injury occurrence and process measures of program implementation in three~     groups of communities:~        -  a control group receiving no special resources or guidance related to fall injury~          prevention or the community health improvement process;~        -  a Standard Program group receiving modest funding to implement an evidence-based~          fall prevention program in their local community;~        -  a Facilitative System group receiving facilitative system support in addition to the~          resources provided the Standard Program group.~      We hypothesize that the Facilitative System program will be more effective at:~        -  reducing fall-related injuries in the elderly;~        -  building community coalitions that are goal-oriented and sustainable;~        -  implementing community-based, evidence-driven fall prevention programs that are both~          tailored to the community needs and yet faithful to empirically-tested fall prevention~          research studies~   "
216208|NCT00729508|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived~     peptide desensitising vaccine, currently being developed for the treatment of cat allergy.~     This study will investigate the efficacy of 4 treatment regimens of Cat-PAD in cat allergic~     subjects following challenge to cat allergen in an environmental exposure chamber (EEC).~   "
216209|NCT00729495|"~     Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is~     bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be~     randomized to yield approximately 80 completers. The study is an open label, randomized,~     2-way crossover with single dosing followed by a 7-day washout period between treatment arms~   "
216212|NCT00729456|"~     This study was an attempt to confirm the results of an earlier experiment in which the~     benefit of an education programme was assessed in a group of people with diabetes complicated~     by ulceration of the foot. Foot ulcers are the source of considerable suffering and cost and~     carry a high risk of amputation: they are difficult to heal and approximately 40% recur in~     the first 12 months. The earlier experiment (published by Malone and colleagues in 1989)~     indicated that a single hour-long education session appeared to lead to a three-fold~     reduction in the numbers of ulcers which recurred after successful treatment. It was not~     possible to confirm these findings in the present study in which patients from three~     specialist clinics in Nottingham and Derby, UK, were allocated either to receive a~     one-to-one, individually targeted, education programme in the own home (and reinforced after~     one month by a telephone call), or to receive usual care. The group who received the~     education reported better recommended foot care behaviour (intended to minimise the risk of~     injury) at 12 months but despite this, there was no difference between the two groups in the~     percentage who suffered either a new ulcer (41% education versus 41% usual care) or~     amputation (10% and 11%, respectively). While the benefit of education is undeniable in~     general, it was not possible to show that this particular teaching session had an impact on~     the occurrence of new disease in this group of patients.~   "
216213|NCT00729443|"~     The study is carried out in order to investigate safety, tolerability and pharmacokinetics~     after administrating single and fractionated doses of AZD3241 to healthy volunteers~   "
216214|NCT00729430|"~     Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the~     body. This study will evaluate a new MRI technique in people who have recently had a heart~     attack. Researchers will also examine the effect of fish oil supplementation on heart health~     in study participants.~   "
216215|NCT00729417|"~     Evaluation of Obstetrical Risk Factors for the development of Urinary and/or Fecal~     Incontinence according to a questionaire~      The questionaire will be filled by the study investigators after the women participating in~     the study sign their consent. The study is based solely on a questionaire and does not~     include any physical examination, blood exam or intervention.~      The study will be performed on the premises of Maaynei Hayeshua medical center. The inclusion~     criteria include women above the age of 18 who arrive to Maaynei Hayeshua Medical center for~     any reason. The data will be transferred to a computerized data base and analyzed~     statistically.~   "
216216|NCT00729404|"~     Investigation of two transdermal hormone patch formulations for contraception regarding~     inhibition of ovulation over a period of 3 treatment cycles in healthy young female~     volunteers~   "
216217|NCT00729391|"~     The purpose of this study is to test the effectiveness of a woman-focused HIV prevention~     intervention combined with voluntary counseling and testing (VCT), compared to VCT only, and~     VCT combined with an attention-control nutrition intervention.~   "
216218|NCT00729378|"~     The Jump-In study will prospectively assess the effects of impact exercise on skeletal~     development in young girls, including bone mass, bone mineral density, and bone geometry. We~     hypothesize that girls who regularly participate in impact loading exercise will accrue~     greater skeletal mass, increase bone density and undergo structural adaptations that in~     combination will improve bone strength compared to girls who do not participate in impact~     exercise.~   "
216219|NCT00729365|"~     The purpose of this study is to determine if the early treatment with a blood pressure~     medication (an ACE Inhibitor) can prevent or delay the development of kidney disease~     (microalbuminuria) in patients with Type 1 diabetes who have normal blood pressure and urine~     albumin levels.~   "
216220|NCT00729352|"~     The research plan proposes translational studies in relevant animal models and human subjects~     in order to identify host (genetic) susceptibility factors that confer vulnerability to the~     prototypal air pollutant, ozone. The results will have significant impact upon, and aid in,~     understanding mechanisms regulating pro-oxidant lung injury, production and secretion of~     airway mucins, and clearance of respiratory mucus, and adverse health effects, that occur~     during and following exposure to airborne respiratory irritants.~   "
216221|NCT00729339|"~     Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In~     Taiwan, this disease is increasing gradually because the investigators' eating style is~     closing to Western world.~      Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent~     is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of~     prokinetic agent in the management of GERD.~   "
216222|NCT00729326|"~     This study is designed to compare the short-term effects and mechanisms of action of~     exenatide with those of sitagliptin when either is added to an oral agent(metformin or a~     thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with~     inadequate glycemic control.~   "
216223|NCT00729313|"~     The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the~     treatment of patients with digestive fistulae.~   "
216224|NCT00729300|"~     The problem of cocaine dependence remains a major medical, social, and legal concern. Several~     studies have suggested that disulfiram may be beneficial for the treatment of cocaine~     dependence. A common assumption has been that disulfiram treatment, by increasing DA~     availability, enhances the aversive aspects of stimulants. This study aims to measure plasma~     activity in those with the C/C DBH genotype, which is associated with higher DBH activity~     subsequently making the disulfiram treatment more effective, as well as determine the effects~     of treatment with disulfiram on cocaine self-administration using a human laboratory model of~     cocaine self-administration.~   "
216225|NCT00729287|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of selenium may keep bladder cancer from growing or coming back. It~     is not yet known whether selenium is more effective than a placebo in preventing cancer~     recurrence in patients with bladder cancer.~      PURPOSE: This randomized phase III trial is studying selenium to see how well it works~     compared with a placebo in preventing cancer recurrence in patients with bladder cancer.~   "
216226|NCT00729274|"~     The purpose of this study is to determine whether nebulized hypertonic saline solution~     reduces the admission rate 48 hours after initial treatment in the emergency department, when~     compared to normal saline solution (placebo). We hypothesise that patients with bronchiolitis~     who receive nebulized hypertonic saline solution will have less respiratory distress, less~     duration of symptoms and therefore less risk of being hospitalized than those receiving~     normal saline solution.~   "
216227|NCT00729261|"~     Identifying the optimal time of extubation in a brain injured population should improve~     patient outcome. Brain injured patients usually remain intubated due to concerns of airway~     maintenance. Current practice argues that unconscious patients need to remain intubated to~     protect their airways. More recent data however suggests that delaying extubation in this~     population increases pneumonias and worsens patient outcomes.~      We designed a safety and feasibility study of randomizing brain injured patients into early~     or delayed extubation. The purpose was to gain insight into patient safety concerns and to~     obtain estimates of sample size needed for a larger study.~   "
216228|NCT00729248|"~     The study is a laboratory investigation comparing the regulatory effects of different~     immunosuppressive therapies in an in vitro human MLR assay of selecting specific~     immunosuppressive therapy to promote a regulatory profile and determining possibly newer~     accepted dosing and drug concentrations for agents most associated with this regulatory~     profile.~   "
216229|NCT00729235|"~     This clinical investigation is a device-based open, prospective, multicenter two-arm~     randomized trial, comparing patients who are treated in the slow VT zone versus patients who~     are not treated in that zone.~      The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin~     Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and~     health authorities will be informed prior to any use of a newer device if applicable.~      All patients will have a 3-zone detection configuration programmed. The slow VT zone will be~     defined by programming the detection parameters as follows:~        -  Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we~          recommend to adjust this parameter to: resting rate + 30 bpm)~        -  VT detection rate: 150 bpm~      PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.~      The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF~     are also left to the investigator's judgment.~      Patients will be randomized at implant to have the slow VT zone programmed as a monitoring~     zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm).~     The randomization table will be generated by Sorin Group/ELA Medical.~   "
216230|NCT00729222|"~     The study will estimate the effects of rolofylline, alone and in addition to loop diuretic~     therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients~     with heart failure and renal impairment.~   "
216231|NCT00729209|"~     This is a Phase 1 study, involving a 29-day treatment period, designed to evaluate the~     pharmacokinetics and the effectiveness of investigational study drug ARRY-371797 in treating~     rheumatoid arthritis in patients receiving stable doses of methotrexate, and to further~     evaluate the drug's safety. Approximately 30 patients from the US will be enrolled in this~     study.~   "
216232|NCT00729196|"~     The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more~     effective for controlling weight and blood glucose in persons with type 2 diabetes.~   "
216233|NCT00729183|"~     This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with~     Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The~     primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine~     compared to placebo at 12 months.~   "
216234|NCT00729170|"~     The aim of the project is to determine if milk supplementation during a caloric restriction~     program facilitates the lost of weight, improves the appetite control and attenuates the~     decrease of bone mineral content in low-calcium consumer women.~   "
216235|NCT00729157|"~     This phase II trial is studying how well aflibercept works in treating patients with~     recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine~     therapy. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor~     and by carrying tumor-killing substances directly to thyroid cancer cells.~   "
216236|NCT00729144|"~     This study focuses on the validation of the Adaptation Index instrument as a measurement of~     adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive~     behaviors among women with FI.~   "
216237|NCT00729131|"~     The research plan proposes to develop translational studies in humans that will identify host~     susceptibility factors that confer vulnerability to the prototypal air pollutant, ozone.~     Ozone is a ubiquitous urban air pollutant and associated with increased emergency room~     visits, and co-associates with other air pollutants, to increase mortality in high risk~     groups (cardio-pulmonary disease) of the population.The results will have significant impact~     upon and aid in understanding mechanisms of pro-oxidant lung injury, airway~     hyperresponsiveness, and adverse health effects, that occur during and following exposure to~     inhalable airborne irritants.~   "
216238|NCT00729118|"~     RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking~     blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when~     given together with lenalidomide after autologous stem cell transplant in treating patients~     with multiple myeloma.~   "
216239|NCT00729092|"~     Specific Aims:~      • The primary objective is to delineate the brain structures that are involved in pain using~     Positron Emission Tomography (PET) imaging.~      Hypothesis:~      Pain will result in increases in metabolism and neuronal activity in specific delineated~     areas of the brain.~   "
216240|NCT00729079|"~     This pilot study is intended to demonstrate that we can actually deliver the Diabetes~     Prevention Program intervention well and to show that it is likely effective. We will use~     results from this pilot study to support our application to The National Institute of Health.~     NIH is asking for health care centers to show ways to provide this treatment at a reasonable~     cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention~     in a primary care health care setting (University of Rochester Primary Care).~   "
216241|NCT00729053|"~     -  Multi-Center~        -  Randomized~        -  Open-Label Study of single agent IMO-2055~        -  Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)~   "
216242|NCT00729040|"~     The purpose of this study is to determine whether online peer support will increase adherence~     to an internet-based pedometer walking program.~   "
216269|NCT00728676|"~     To validate the outcome measures and the tolerability of Kuvan treatment in the improvement~     of behavioral symptoms in 10 selected adults with Phenylketonuria (PKU) with or without~     mental retardation.~   "
216243|NCT00729027|"~     The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on~     to ongoing statin treatment in a double-blind manner in comparison with placebo, in the~     management of patients with primary hypercholesterolemia considered as inadequately~     controlled despite their ongoing statin treatment.~      The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C~     level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters~     will be assessed as secondary objectives.~   "
216244|NCT00729014|"~     The purpose of this study is to identify incidence of Chinese herb nephropathy in a medical~     center~   "
216245|NCT00729001|"~     This is a dose exploration study to assess the safety and immunogenicity of two doses of the~     candidate HRV vaccine at different virus concentrations in the target age group (infants~     approximately 2 months of age and previously uninfected with human rotavirus) and receiving~     concomitant administration of routine vaccinations. The study also aims at exploring the~     effect of unrestricted feeding on the immunogenicity of the vaccine.~   "
216246|NCT00728988|"~     This present study is specifically designed to examine the efficacy and safety of a high~     pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic~     of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.~   "
216247|NCT00728975|"~     The project's primary purpose is to establish a network of Hospice Palliative Care settings~     using a common and consistent method of assessing and documenting bowel functioning in order~     to be able to carry out future collaborative studies of constipation treatments. The~     secondary goal is to gather normative data on current bowel care function and outcomes of~     current treatments which can be used to determine sample size calculations for future~     controlled trials of bowel management protocols. In order to complete this goal the project~     requires a thorough assessment of current nursing practice in regard to bowel care.~   "
216248|NCT00728962|"~     This prospective, multicenter study evaluates the performance of the Osseotite Prevail~     implant when to support a short fixed bridge with immediate occlusal loading, providing the~     patient with the use of a temporary prosthesis until the final prosthesis is made.~      Study (null) hypothesis: This is an observational study in which no concurrent control group~     will be observed. Results of the study will be compared with the performance of other~     Osseotite implants from published Osseotite multicenter studies.~   "
216249|NCT00728949|"~     The purpose of this study is to determine whether IMC-A12 offers increased progression-free~     survival (PFS) associated with IMC-A12 monotherapy and IMC-A12 in combination with an~     antiestrogen therapy in patients with hormone receptor positive advanced or metastatic breast~     cancer that have experienced disease progression on antiestrogen therapy.~   "
216250|NCT00728936|"~     First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.~   "
216251|NCT00728923|"~     Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3%~     of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as~     obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only~     medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with~     SRI treatment, most patients continue to experience significant OCD symptoms, impaired~     functioning, and diminished quality of life. Recent evidence suggest that a different~     neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target~     glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from~     OCD. In this study we are recruiting patients to receive the drug NPL-2003, which is thought~     to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are~     taking in a 12-week open label study.~   "
216252|NCT00728910|"~     The investigators propose to investigate if using a combination of medications that may~     improve cholesterol give additional benefit to that gained from the statin medication,~     Lipitor. It is recommended that patients who meet certain criteria for risk of heart disease~     take a statin medication to improve cholesterol and hopefully reduce risk of heart disease.~     The combination therapy will include Lipitor, Niaspan, and investigational medication (known~     as ABT335) in a class of drugs called fibrates. We are looking to see if and how these three~     medications together might improve risk factors for atherosclerosis and influence HDL~     cholesterol. The study will also look at the safety and any side effects that might be~     associated with this combination of medications.~   "
216253|NCT00728897|"~     Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because~     we plan to have only single capsules administered in the later phase clinical trials but we~     have not had a 100mg strength before. As this is a new previously untested strength we need~     to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess~     the effect of high fat food on the PK of the 100mg capsule. The study is planned to consist~     of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There~     will be a week wash out between each dose. In the three dosing periods subjects will either~     received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or~     100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14~     days after the final dose. It is expected that the total duration of the study should be~     approximately eight weeks.~   "
216254|NCT00728884|"~     This observational, prospective clinical study evaluates the performance of the Certain~     Prevail implant system to show potential crestal bone and soft tissue preservation following~     the crestal bone. It will also evaluate implant performance.~      Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants~     will be the same as that for standard non-platform switched implants from contemporaneous~     studies (historical controls).~   "
216255|NCT00728871|"~     A. To investigate the relationship between serum titer of anti-HPV16 antibody and~     clinicopathological factors of cervical cancer patients.~      B. To investigate that if the serum titer of anti-HPV16 antibody could be a prognostic factor~     in the cervical cancer patients.~      C. To investigate the serum titer of anti-HPV16 antibody in HPV16-infected populations with~     various disease status such as infection only, precancerous lesion, and early and advanced~     cervical cancer.~   "
216285|NCT00728468|"~     Research in test tubes suggests that may affect cytochrome P450 2D6 (CYP2D6), an important~     enzyme that is responsible for eliminating many drugs that cancer patients need to take,~     including dextromethorphan. The purpose of this study is to test the impact of PF-00299804 on~     the activity of CYP2D6, and how the human body handles dextromethorphan.~   "
216257|NCT00728845|"~     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, carboplatin, and~     paclitaxel and work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Giving hydroxychloroquine together with carboplatin, paclitaxel and bevacizumab may kill more~     tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of~     hydroxychloroquine when given together with carboplatin, paclitaxel, and bevacizumab and to~     see how well they work in treating patients with recurrent advanced non-small cell lung~     cancer.~   "
216258|NCT00728832|"~     The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test~     dose administration on the PK profile of a single epidural dose of DepoDur (extended-release~     epidural morphine) in patients undergoing major upper abdominal surgery. A secondary~     objective was to evaluate the safety and efficacy profile.~   "
216259|NCT00728819|"~     The purpose of this study is to compare two different marketed PICC (peripherally inserted~     central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion~     will be compared. It is hypothesized that the non-tapered design has a lower clotting rate~     and is easier to place than the tapered design. Bleeding rates are expected to be about the~     same.~   "
216260|NCT00728806|"~     This study will examine the peritoneal tissue, serum and dialysate proteins of peritoneal~     dialysis (PD) patients with different types of peritoneal solute transport by differential~     proteomics techniques.~      This study will be performed to identify the molecular difference between different types of~     peritoneal solute transport and explore biomarker for early detection as well as early~     intervention of peritoneal ultrafiltration failure.~   "
216261|NCT00728793|"~     This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced~     and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal~     growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and~     histone deacetylase (HDAC). The study is designed to establish the safety, including the~     maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.~   "
216262|NCT00728780|"~     The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from~     ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.~   "
216263|NCT00728767|"~     The purpose of the study is to determine whether a brief intervention (a short conversation~     build on the principles of motivational interviewing) is effective in lowering self reported~     alcohol use in heavy drinkers.~   "
216264|NCT00728754|"~     This prospective, randomized study will evaluate the performance of the Osseotite Certain~     Prevail implant when compared to that of the non-lateralized version of the implant.~      Study (null) hypothesis: the crestal bone changes that take place after placement and loading~     of the Osseotite lateralized implants will be the same as for a similar but non-lateralized~     Osseotite Certain implant.~   "
216265|NCT00728741|"~     This study will locate areas in the brain that help people devise action plans to carry out~     complex tasks requiring use of strategy. The ability to plan strategically is impaired in~     patients who have had a stroke affecting the front parts of the brain. This study will use~     functional magnetic resonance imaging (fMRI) to examine the activity of different areas of~     the brain during the formulation and execution of plans.~      Right-handed healthy volunteers between 18 and 60 years of age may be eligible for this~     study. Participants come to the NIH Clinical Center four to five times to complete the~     following procedures:~      Visit 1 - Screening~        -  Medical history~        -  Physical and neurological examinations~      Visit 2 - MRI brain scan (if one has not been done within the past year)~      MRI - This test uses a strong magnetic field and radio waves to obtain images of the brain.~     The scanner is a metal cylinder surrounded by a magnetic field. The subject lies on a table~     that can slide in and out of the scanner, wearing earplugs to muffle loud noises that occur~     during the scanning.~      Visits 3 to 5 - Task training sessions and two fMRI scans~      Functional MRI involves taking MRI scans while the subject performs a task in order to learn~     about changes in brain regions that are involved in the performance of the task. Subjects are~     trained in two tasks (see below) and then perform the tasks while in the MRI scanner.~        -  Task 1: The subject presses computer keys in response to the direction of arrows shown~          on the computer screen. The keys are pressed according to a given set of rules the~          subject is taught.~        -  Task 2: This task is similar to task 1, but the subject is also asked to remember~          certain previous actions and responses.~   "
216266|NCT00728728|"~     This study will investigate adjunctive pregnenolone for patients with schizophrenia and~     schizoaffective disorder.~   "
216267|NCT00728715|"~     Some studies have concluded that high-dose inhaled steroids (IS) are effective in the~     clinical control of patients with bronchiectasis, however the high doses needed provokes some~     adverse effects and lower doses are not effective. Combined treatment with budesonide and~     formoterol have demostrated to be effective in patients with asthma and COPD achieving the~     reduction of steroid dose thanks to the adition of a long-acting beta 2 agonists. There are~     no studies in the literature analysing the effect of combined treatment in patients with~     bronchiectasis. The objective of this study is to compare the efficacy and safety of~     formoterol-medium dose of budesonide in a single inhaler versus high-dose of budesonide in~     the clinical control of patientes with non-cystic fibrosis bronchiectasis.~      Study Design:~      Randomized (3 months) parallel groups study.~      Patients:~      Patients with bronchiectasis diagnosed by high-resolution CT scan and chronic obstructive~     airway obstruction.~      Exclusion:~      Asthma and current or past smokers.~      Methods:~      Run in period in all patients with high dose of budesonide (1600 mcg/day) for 3 months. After~     that, randomization into two groups: 1. The same treatment (1600 mcg/day of budesonide) or~     combined treatment with lower dose of budesonide (18 mcg/day of formoterol and 800 mcg of~     budesonide) in a single turbuhaler inhaler during 3 months.~      Studied variables:~      Clinical, functional, quality of life, microbiological and number of side effects.~   "
216268|NCT00728689|"~     The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a~     single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy~     volunteers.~   "
216270|NCT00728663|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Cetuximab may also stop the growth of~     prostate cancer by blocking blood flow to the tumor. Giving docetaxel together with cetuximab~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with~     cetuximab and to see how well it works in treating patients with metastatic prostate cancer.~   "
216271|NCT00728650|"~     This study will review the treatment and outcomes of patients having primary and metastatic~     hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency~     ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not~     receiving these treatments. Tumor recurrence and survival data will be compared to the~     published literature to determine the efficacy of current treatment strategies in this~     patient population.~   "
216272|NCT00728637|"~     The primary objective of the FIT Heart Study was to test the effectiveness of a~     hospital-based standardized screening and educational intervention targeted to family members~     of patients hospitalized with CVD, to increase adherence to CVD prevention guidelines.~   "
216273|NCT00728624|"~     EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000~     isolates from 15- 20 sites).~      Objectives:~        -  Comparison of antimicrobial susceptibility using disc-diffusion method~        -  Assessing prevalence of beta-lactamase producing strains among clinical isolates~          obtained from hospital in-patients~   "
216274|NCT00728611|"~     to evaluate the influence of PRGF treatment on patient suffering from OA knee~   "
216275|NCT00728598|"~     Fractalkine (FKN) is a chemoattractant and adhesion molecule for leukocytes. Angiogenic~     effect of FKN also has been reported. We investigate FKN-mediated angiogenesis in ocular~     angiogenic disorders.~   "
216276|NCT00728585|"~     RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and~     radiation therapy in young patients undergoing stem cell transplant.~      PURPOSE: This randomized phase II trial is studying palifermin to see how well it works~     compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation~     therapy in young patients undergoing stem cell transplant.~   "
216277|NCT00728572|"~     The purpose of this investigation is to determine the effect of Logan Basic Technique apex~     contact adjustment (LBT); on the motor recruitment pattern in the erector spinae group via~     surface EMG.~   "
216278|NCT00728559|"~     In the literature there is conflicting data on administration of local analgesia in addition~     to the general anesthesia to the trocar sites during laparoscopy, We believe that adding~     local analgesia to the general anesthesia during laparoscopy is beneficial . the current~     study will evaluate prospectivly the impact of local analgesia on postoperative pain and~     recovery in patients undergoing operative laparoscopy~   "
216279|NCT00728546|"~     Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in~     patients with anti-TB medication induced hepatitis.~   "
216280|NCT00728533|"~     An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and~     Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer~     Requiring Androgen Ablation Therapy.~   "
216281|NCT00728520|"~     The drug that will be used in this study is called Azacitidine. Azacitidine belongs to a~     group of drugs which may restore normal control in cancer cells by affecting the genes and~     proteins in the body. Azacitidine is approved by the FDA for the treatment of Myelodysplastic~     Syndrome (MDS), a pre-leukemic bone marrow disease. The purpose of this study is to find out~     what effect the drug Azacitidine has on Acute Myeloid Leukemia (AML) in elderly patients.~   "
216282|NCT00728507|"~     Although effective therapy for tuberculosis is available, TB continues to cause significant~     problems worldwide, and rates of multi-drug resistant (MDR) TB cases are on the rise. A major~     obstacle to the control of TB is poor adherence with lengthy (usually 6 months) and~     complicated treatment regimens. Incomplete TB treatment can lead to serious consequences such~     as increased severity of illness and death, prolonged infectiousness and transmission in the~     community, and the development of drug resistance. The development of new treatment~     strategies with more stronger drugs could lead to shorter and simpler regimens. A TB~     treatment regimen that allowed treatment duration to be meaningfully decreased would have~     important public health implications.~      This trial will compare the effect and safety of a new oral regimen to that of the standard~     regimen for the first phase of treatment for pulmonary tuberculosis.~      The experimental regimen will consist of the following:~        -  Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered~          once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~      The standard control intensive phase regimen will consist of the following:~        -  Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once~          daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~      Following intensive phase therapy (the study phase), all patients will be treated with a~     non-experimental continuation phase regimen.~      In mice, the combination of Moxifloxacin and Rifapentine have cured the animals significantly~     faster than the standard regimen and this study will be the first step to see if the~     potential is also there in humans.~   "
216283|NCT00728494|"~     Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C.~     Patients in the first one will receive a patient assistance program, and patients in the~     second group will not. All patients will receive PegIntron and Rebetol according to label.~   "
216284|NCT00728481|"~     The primary aim of this study was to determine the proportion of patients with esophageal~     eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal~     reflux disease (GERD).~      This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD~     would receive relief from taking the medication Nexium or a steroid called Pulmicort.~      The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus~     as a predictor of endoscopic, histological and symptomatic response in patients with EE.~   "
216301|NCT00728260|"~     To further characterize the safety profile of Menactra vaccine and to identify any signals of~     potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.~   "
216286|NCT00728455|"~     This trial will be conducted in the United States of America (USA). The aim of this clinical~     trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated.~      Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349~     or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as~     well as subject reported adverse events will be evaluated. If safe to proceed, the next group~     of subjects will be given a higher dose and the safety evaluation performed again before~     proceeding. In total, 5 dose levels will be evaluated.~      Subjects will be administered a dose and remain in the clinic until the morning of Day 8~     after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic~     samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for~     repeat blood draws and safety labs. Day 22 is the final study visit.~   "
216287|NCT00728442|"~     The objective of the study is to evaluate how the use of OncoDoc2, a computerized~     guideline-based decision support system, could improve the compliance of multidisciplinary~     staff meeting decisions with local clinical practice guidelines in the management of~     non-metastatic breast cancer.~   "
216288|NCT00728429|"~     RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help~     improve heart health.~      PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and~     to see how well it works in patients receiving chemotherapy for cancer.~   "
216289|NCT00728416|"~     This study seeks to prospectively demonstrate that Nasonex is better than placebo in~     relieving nasal congestion in patients with seasonal allergic rhinitis.~   "
216290|NCT00728403|"~     The study is a 2 phase double blind randomized placebo control trial. The objective is to~     asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.)~     extract and Korean Red Ginseng (steamed Panax C.A. Meyer) extract in the management of type 2~     diabetes in a 12 week period. One Hundred and twenty subjects with type 2 diabetes~     (hyperglycemia key inclusion criteria: HbAlc≥6.5% - ≤ 8.1% ) will participate in the study~     (36 men and 36 post-menopausal women).~   "
216291|NCT00728390|"~     This study will explore the combination of the oral drug PF-00299804 and intravenous~     CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given~     separately to patients in prior studies, and this study is to establish the safety and~     efficacy of the combination.~   "
216292|NCT00728377|"~     Women diagnosed with gestational diabetes mellitus (GDM) are at substantially increased risk~     of developing type 2 diabetes and obesity, currently at epidemic rates in the United States.~     GDM, therefore, identifies a population of women at high risk of developing type 2 diabetes~     and thus provides an excellent opportunity to intervene years before the development of this~     disorder. It is well recognized that acute as well as chronic physical activity reduce~     fasting plasma glucose as well as improve glucose tolerance in type 2 diabetes. Recent~     studies have suggested that women with higher levels of physical activity have reduced risk~     of GDM. Therefore, we will test the hypothesis that an exercise intervention is an effective~     tool for preventing GDM among women with a history of GDM.~   "
216293|NCT00728364|"~     Anderson-Fabry disease is a rare X-linked lysosomal storage disorder due to the deficiency of~     alfa-galactosidase A (AGAL). The subsequent accumulation of glycosphingolipids may lead to to~     cardiac, renal, and central nervous system impairment as well as premature death. Recently~     published studies suggest that the true incidence of the disease may be underestimated in~     certain risk groups, e.g. in patients with chronic kidney disease (CKD).~      Therefore, the investigators initiated a multicenter case-finding study in Austria by~     screening patients with chronic kidney disease not yet on renal replacement therapy.~     Molecular isoforms of globotriaosylceramide (Gb3), characterized by different chain lengths~     of their N-acyl residues, will be determined in a urine sample. Characteristic parameters,~     including the ratio of C24/C18 isoforms will be used for identifying patients liable to have~     the disease. A positive result will be confirmed by biochemical and genetic testing.~      A sample size of 5.000 chronic kidney disease patients is envisaged allowing for detection of~     1 to 25 patients with Anderson-Fabry disease.~   "
216294|NCT00728351|"~     The present study is designed to evaluate the efficacy and safety of fixed combination~     therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes~     inadequately controlled with prior metformin monotherapy.~   "
216295|NCT00728338|"~     The purpose of this study is to determine the effects of supplementing diets of~     hyperlipidemic men with DHA (docosahexenoic acid) on risk factors for cardiovascular disease.~     We hypothesize that supplementing diets of hyperlipidemic men with DHA will decrease the~     plasma concentrations of CRP (C-reactive protein), inflammatory cytokines, and soluble~     adhesion molecules. We further hypothesize that DHA supplementation will decrease serum~     triglyceride concentrations and increase HDL concentration.~   "
216296|NCT00728325|"~     This prospective randomized study evaluates the impact of Supportive Employment (SE) compared~     to standard vocational rehabilitation (VRP) on occupational, sobriety, psychiatric, and~     quality of life outcomes and health care costs for veterans with chronic posttraumatic stress~     disorder (PTSD).~   "
216297|NCT00728312|"~     The purpose of this study is to test whether treatment with Aripiprazole leads to a reduction~     in methamphetamine craving and use in patients diagnosed with methamphetamine dependence.~     Patients presenting at the Omaha VA Medical Center for treatment of methamphetamine~     dependence, and meet inclusion criteria for the study will be invited to participate.~     Participation in the study will last for approximately 14 weeks.~   "
216298|NCT00728299|"~     Increases in carotid artery intima-media thickness (IMT) are correlated with increased risk~     of stroke and myocardial infarction. The purpose of this study is to assess if pomegranate~     juice will retard the carotid (IMT) progression rate in men and women who have one or more~     existing cardiovascular risk factors (current cigarette smoking, hypertension, low~     HDL-cholesterol, and/or high LDL-cholesterol) upon entrance into the study.~   "
216299|NCT00728286|"~     The purpose of this study is to assess platelet dependent thrombogenicity in patients after~     acute coronary syndrome using an ex vivo arterial injury model.~   "
216300|NCT00728273|"~     The aim of this study is to identify the effect of a school-based food fortification~     intervention with multi-micronutrients with or without deworming to improve anemia,~     micronutrient status, cognitive function, health (morbidity and reinfestation rate) and~     growth (ponderal) in Vietnamese primary schoolchildren.~   "
216302|NCT00728247|"~     Hypothesis: Kinematic parameters can be used to monitor changes in three-dimensional head~     movements after Manual Therapy treatments.~      Subjects who have some level of cervical dysfunction will be examined by an experienced~     Osteopathic physician. During the clinical assessment of cervical lateral flexion, kinematic~     data will be recorded. Subjects will be treated using manual therapy techniques and kinematic~     data will be recorded again at set intervals after the treatment.~   "
216303|NCT00728234|"~     The study included analysis of longitudinal recordings of amplitude-integrated EEG (aEEG)~     tracings on a weekly basis in preterm infants and evaluation of their neurodevelopmental~     outcome at the age of three years.~      Aim of the study was to observe if there is a correlation of the aEEG tracings of the first~     weeks of life to later neurodevelopmental outcome and to evaluate if aEEG can be used as~     prognostic tool.~   "
216304|NCT00728221|"~     Ginseng has been used for many years in a wide array of anecdotal medicinal properties.~     Animal and limited clinical research points to the vascular effects of Korean Red Ginseng~     (KRG). The present project aims to assess the efficacy of KRG and contribution of its~     factionated components on various indices of vascular function in healthy individuals. Our~     primary objective is to compare the acute effects of KRG and placebo on endothelial function.~     Moreover, our secondary objective is to evaluate the effect of isolated KRG factions on~     arterial stiffness, blood pressure and vasoactive markers. We hypothesize that (1)~     consumption of KRG will cause an improvement in endothelial function in healthy individuals,~     as compared to placebo; (2) consumption of KRG will cause an improvement in arterial~     stiffness and blood pressure in healthy individuals, as compared to placebo; (3) the~     ginsenoside faction of KRG is primarily responsible for the anticipated vascular effects.~   "
216305|NCT00728208|"~     This study will consist of 4 parallel cohorts of healthy volunteers (elderly male, elderly~     female, young male and young female). Subjects will receive either GSK372475 1.5mg or placebo~     for 28 days.~   "
216306|NCT00728195|"~     The purpose of this study is to evaluate the efficacy and safety of 3 fixed doses of~     JNJ-37822681 compared with placebo (an inactive substance that is compared with a drug to~     test if the drug has a real effect in a clinical trial) after 6 weeks treatment and~     olanzapine after 12 weeks treatment in participants with schizophrenia (psychiatric disorder~     with symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self).~   "
216307|NCT00728182|"~     This is a randomized, double-blind, placebo-controlled, single-dose, design investigating the~     safety, tolerability and efficacy of NA-1, a peptide designed to reduce ischemic brain~     damage. Up to 200 male and female patients undergoing endovascular repair of brain aneurysm~     will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after~     completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo~     interim procedures Days 2-4 and end-of study procedures on Day 30. Standard safety criteria~     will be analysed. Efficacy endpoints include the ability of NA-1 to: 1) reduce the volume of~     ischemic embolic strokes, 2) reduce the number of ischemic embolic strokes, 3) reduce~     vascular cognitive impairment, and 4) reduce the frequency of large strokes induced by the~     endovascular procedure. The plasma concentrations of NA-1 will also be analyzed.~   "
216308|NCT00728169|"~     The purpose of this study is to identify community resources and challenges in improving the~     health of community members with asthma.~      The primary goal of this project is to use Community-Based Participatory Research methodology~     to develop interventions aimed at improving asthma management in high-risk African American~     asthmatics. This ground-up longterm approach has never been tested before in asthmatics.~     The primary goal of this study will be accomplished with four specific aims:~      Aim 1. Conduct focus groups to identify barriers to asthma management in the target~     population.~      Aim 2. Use a community advisory board (CAB) consisting of participants selected from the~     various focus groups to gather information about solutions for the above barriers.~      Aim 3. Use the information from the CAB to develop an intervention to improve asthma self~     management behaviors in the target population.~      Aim 4. Refine the developed intervention based on feedback from focus groups conducted in Aim~     1.~   "
216309|NCT00728156|"~     Patients with diabetes are more likely to develop furring of their coronary arteries and~     present with angina and heart attacks. Furthermore, after such an event, they have poorer~     outcomes (higher rates of death) and survivors are more likely to have recurring symptoms.~     Using a novel clotting chamber the investigators have shown that patients with diabetes are~     more likely to develop blood clots. This study will look at the role of different blood~     thinning medications in patients with diabetes. If successful, the investigators will provide~     evidence to conduct large clinical studies to look at the role of additional blood thinning~     medication in reducing heart attacks and strokes in patients with diabetes.~   "
216310|NCT00728143|"~     Our objective was to test whether the highly viscous polysaccharide incorporated into the~     biscuit formulation would reduce the postprandial blood glucose response equally in healthy~     subjects and individuals with type 2 diabetes.~   "
216311|NCT00728130|"~     Hypothesis~        1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with~          head and neck cancer despite the presence of metastatic disease in the lymph nodes that~          surround it.~        2. All the lymph nodes in the submandibular triangle can be removed without resection of~          the submandibular gland.~      Study Design~      A better understanding of the frequency of submandibular gland involvement may lead to~     refined treatment strategies for head and neck cancer, which can possibly spare removal of~     the submandibular gland and potentially improve the long term side effects from therapy.~   "
216312|NCT00728117|"~     We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen~     therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding~     intolerance and shorten the time period that infants need to tolerate full enteral nutrition.~     We also hypothesize that this intervention will minimize the alterations in intestinal~     permeability that occur with these drugs and will improve the infants' hemodynamic response~     to enteral nutrition~   "
216313|NCT00728104|"~     This is a study with the principle goal being to learn about the use of L-Carnitine and~     CoQ10, two vitamin supplements that are currently being used to treat Cyclic Vomiting~     Syndrome, largely initiated by parents. We want to learn how effective these supplements are~     compared to standard treatment, at what dose, and what onset of action in order to initiate~     future prospective study on these supplements.~   "
216316|NCT00728065|"~     Salvia hispanic (Salba) is postulated to increase satiety. This study determines the optimal~     amount of Salba as well as whether liquid or solid enriched products will produce maximum~     satiety. The results can gauge the effectiveness of Salba in weight loss programs. The study~     has a randomized, double-blind crossover design which includes 10 test meals and capillary~     blood sampling to perform glucose and insulin analyses (to determine blood glucose response~     and blood insulin response).~   "
216317|NCT00728052|"~     Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise~     healthy volunteers. This study is required because this drug is being developed for the~     treatment of nicotine dependence. It is important to evaluate how this drug interacts in~     healthy smokers. The study is planned to consist of a single part, with 4 dosing periods.~     Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at~     least 1 week of wash out between doses. In each dosing period 14 subjects will receive~     escalating doses and 4 subjects will receive placebo. The actual doses used will be~     determined based on the safety/ tolerability and pharmacokinetics during the previous dose.~     It is expected that the duration of this study will be approximately 10 weeks.~   "
216318|NCT00728039|"~     1. Characterize the quality of life of young children with CVS (i.e., psychological,~          social, physical, school functioning) and the impact of the child's illness on the~          parent's and family's quality of life (i.e., emotional, social, cognitive functioning,~          communication, worry, daily activities and family relationships).~        2. Assess symptoms of depression, anxiety, ADHD and behavioral problems in what our~          preliminary data suggests is a psychiatrically vulnerable population.~        3. Evaluate the associations between quality of life and psychiatric symptoms and the~          frequency and intensity of CVS attacks.~        4. Use the data generated from this study to develop a psychosocial intervention targeted~          at young children with CVS and their families who evidence risk for functional~          disability, with the aim of intervening as early as possible to limit the psychological~          and social morbidity experienced by children with CVS and their and families.~   "
216319|NCT00728026|"~     Retrospectively review the charts of all children who had heart rate variability, deep~     breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing,~     quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's~     Hospital of Wisconsin.~   "
216320|NCT00728013|"~     In summary, the CHILLAS study will be the first multicenter study performed in a Chinese~     population using a patient-level analysis to compare the effects and safety of intensive~     statin therapy with that of moderate statin therapy. Therefore, it will determine whether~     lower is better, that is, whether LDL cholesterol lowering to a level of approximately~     100mg/dl provides a benefit inferior to that of LDL cholesterol lowering to a much lower~     level; examine the role of inflammatory markers in predicting cardiac events and response to~     statin therapy; and evaluate the effects of statin therapy on regression of coronary~     atherosclerosis using IVUS.~   "
216321|NCT00728000|"~     The goal of this study is to determine the effect of chemotherapy on decreasing the size of~     unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this~     study may provide information on how tumors behave when exposed to certain types of~     chemotherapy.~   "
216322|NCT00727987|"~     The purpose of this study is to evaluate the safety and effectiveness of golimumab in~     patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is~     to evaluate the pharmacokinetics of golimumab.~   "
216323|NCT00727974|"~     The purpose of this study is to determine if there are genetic variations that can explain a~     genetic basis for cyclic vomiting syndrome (CVS).~   "
216324|NCT00727961|"~     The aim of this study is to evaluate efficacy and tolerability, and number of positive~     response to treatment with CAELYX (50 mg/m^2), administered as monotherapy once per 4 weeks~     to patients with metastatic epithelial ovarian cancer, resistant to previous platinum~     therapy.~   "
216325|NCT00727948|"~     Changes in major angiogenic proteins have been seen following initiation of tamoxifen and~     aromatase inhibitor therapy in women with breast cancer. One source of these proteins is the~     circulating platelet pool. The investigators hypothesize that in addition to their~     anti-platelet properties, agents such as aspirin can be used as targeted anti-angiogenesis~     therapy. The investigators will determine the influence of aspirin on the release of~     angiogenic proteins from platelets in 35 patients with breast cancer.~   "
216326|NCT00727935|"~     Lateral episiotomy is a current care practiced with childbirth room. One of the problems~     encountered with this surgical act is the residual pain on perineal scar level. Maximal~     during the first 24 hours, this pain can persist several days or several weeks hampering to~     variable degrees a normal recovery of autonomy and comfort of life. Some studies have shown~     the interest of ropivacaine, local anaesthetic with a long action's duration for proctologic~     surgeries and for the cure of inguinal hernia. A recent study shown the ropivacaine perineal~     infiltration used prior perineorrhaphy allows an absence of post-partum pain for 24 to 27% of~     cases and a first analgesics request delayed to ten hours.~      Methodology: 165 parturients having an epidural analgesia and an episiotomy were enrolled.~     The perineal infiltration was randomized according to 3 equal groups (placebo, ropivacaine~     0,75%, lidocaine 1%) and realised prior perineorrhaphy. then The parturient were followed~     during the 24 first hours. This study was designed as double blind and the study conduct was~     standardized in order to get only variable such as the episiotomy infiltration.~   "
216327|NCT00727922|"~     Oxaliplatin is a major antitumor agent but its use is limited by potentially disabling~     neurotoxicity, characterized by a sensitive defect in the extremities.Mangafodipir is a MRI~     contrast agent with antioxidant properties. Our previous laboratory works showed that~     mangafodipir is able to prevent hematologic toxicity of several chemotherapy agents,~     including oxaliplatin and to increase their antitumor activity. Preliminary clinical data~     suggested that mangafodipir could prevent oxaliplatin neurotoxicity.The primary purpose of~     the present study is to assess the protective effect of mangafodipir in patients who have a~     already moderate oxaliplatin neuropathy and in whom the continuation of this treatment is~     desirable because of significant antitumor effect.~   "
216707|NCT00722839|"~     RATIONALE: Vaccines made from peptides may help the body build an immune response to kill~     cytomegalovirus.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     preventing cytomegalovirus in healthy participants.~   "
216328|NCT00727909|"~     This study is being conducted to evaluate the benefits of in-the-ear vs. open-fit~     behind-the-ear hearing aids. We want to learn more about which patients prefer each type, so~     we can make better choices about which type of hearing aid is best for which patients.~     Participants in this study will try three different sets of hearing aids for 2 months each,~     then we will evaluate the benefit of each type. Participants must be Veterans who are~     eligible for audiology care at one of the three participating sites.~   "
216329|NCT00727896|"~     Type 2 diabetes is a chronic metabolic disorder requiring lifestyle modification and~     medicines, adherence to which has to be practised on a daily basis.~      Motivation of patients to adhere to treatment is difficult in clinical practice. It is well~     documented that majority of patients do not reach the glycaemic targets even in the centres~     of excellence. Regular short service messages (SMS) through cell phones could have a positive~     effect on behaviour and adherence to life style changes and compliance to drugs. It may be~     practical and feasible to use information technology as an effective and simple tool for~     motivating patients to adhere to the prescribed treatment regimen.~      In diabetic patients, frequent reminders regarding the need for adherence to LSM and drugs by~     the medical professionals will improve the compliance.~   "
216330|NCT00727883|"~     Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast~     Cancer patients~   "
216331|NCT00727870|"~     Shave biopsies are often uncomfortable during the healing process. This is a preliminary~     study to determine if patients and clinicians prefer using PolyMem formulating dressings on~     shave biopsy sites compared to the current standard of practice, which is antibiotic ointment~     covered with a band-aid type dressing.~   "
216332|NCT00727857|"~     The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID),~     combined with metformin versus pioglitazone taken alone and metformin taken alone in treating~     Type 2 Diabetes Mellitus.~   "
216333|NCT00727844|"~     This study, conducted in Masan and Seoul, South Korea, investigated the effectiveness of~     linezolid (LZD) in treating patients with extensively drug resistant tuberculosis (XDR TB).~     Because regular medicines do not work well against XDR TB, many more people die from it than~     from regular TB, which can be successfully treated by taking TB medication for 6 months.~     Linezolid has been used to treat other kinds of infections, but has not been well studied for~     TB. This study examined the side effects and effectiveness of prolonged treatment with~     linezolid at two different doses.~      People 20 years of age and older who have XDR TB were eligible for this 3-year study.~      Participants underwent the following tests and procedures:~        -  LZD treatment: Patients were randomly assigned to one of two study groups. Group 1~          patients were observed for 2 months before starting LZD, while group 2 patients begin~          taking LZD right away. Both groups began with a 600 mg daily dose of LZD. After patients~          stopped coughing up TB germs (or after 4 months on LZD) they were randomly assigned~          either to continue taking 600 mg of LZD for the rest of the study or to take a decreased~          dose of 300 mg. In addition to LZD, patients continued to take their currently~          prescribed TB medications.~        -  Medical history.~        -  Physical examinations each month during treatment.~        -  Sputum collections once a week or more until 3 weeks after the patient was no longer~          contagious.~        -  Blood draws every week for 16 to 24 weeks and then once a month.~        -  Urine collections at several time points.~        -  Nerve and eye examinations before starting treatment and then monthly to look for~          possible LZD side effects.~        -  CT scans of the lungs three to four times the first year and once more later in the~          study. For this test the patient lay on a table within the doughnut-shaped CT scanner~          while special X-ray pictures are taken.~      Patients who participated in a substudy had PET scans instead of the CT scans. For this test,~     the patient was given an injection into a vein of a radioactive chemical that can be detected~     by a special camera and viewed on a screen. The patient lay on a table within the~     doughnut-shaped scanner while pictures were taken.~   "
216334|NCT00727831|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate and leucovorin, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Glucarpidase may help return the level of methotrexate in the blood to a safe~     range. Giving high-dose methotrexate together with glucarpidase and leucovorin may kill more~     cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of methotrexate~     when given together with glucarpidase and leucovorin in treating patients with newly~     diagnosed primary central nervous system lymphoma.~   "
216335|NCT00727818|"~     The purpose of this study was to evaluate by histology and histomorphometry, thirty human~     osseous biopsies sampled from fifteen patients (2 biopsies per patient) following 3 months of~     implantation. This study is part of a splitting-blind clinical investigation to compare the~     performance and safety of INION GTRTM Biodegradable Membrane System to resorbable bilayer~     Bio-Gide®-membrane of Geistlich biomaterials in enhancing bone regeneration after removal of~     wisdom teeth.~      The bone defect and alveolar cavity were augmented with Spongostan® dental 1x1x1cm, Johnson &~     Johnson, Spreitenbach, Switzerland. The extraction sites were covered on one side with an~     INION GTRTM Biodegradable Membrane System and on the other with Geistlich resorbable bilayer~     Bio-Gide®-membrane.~      This study was conducted in adaptation to the ISO 10993 Standard : Biological Evaluation of~     Medical Devices, Part 6 (2007): Tests for Local Effects after Implantation.~      This study was conducted in accordance with the requirements of the FDA (Department of health~     and human services) Good Laboratory Practice (GLP) Regulations, 21 CFR 58 (revised as of~     April 01, 2005) and in accordance with the requirements of the OECD Good Laboratory~     Practices, reference ENV/MC/CHEM (98) 17, adapted by council on November 26th 1997.~        -  Trial with medical device~   "
216336|NCT00727792|"~     The purpose of the study is to improve chest MRI exams, eventually resulting in improvements~     in patient care.~   "
216337|NCT00727779|"~     Prevention and treatment strategies for diabetes use exercise as the cornerstone. Even though~     endurance training and strength training both improve insulin resistance, strength training~     may be better suited for persons at risk for type 2 diabetes. We will expand our pilot~     studies of muscle adaptation induced by resistance exercise training to determine the~     biochemical mechanisms that will cause people with the Metabolic Syndrome to secure major~     benefit from intense strength training.~   "
216338|NCT00727766|"~     This is a phase I study designed to test the safety of oral clofarabine when given as~     consolidation therapy to older patients with AML in remission.~   "
216339|NCT00727753|"~     The objective of this study is to evaluate the effects of 2 intravitreal injections with~     Ranibizumab or Avastin on endothelial function in subjects with neovascular macular~     degeneration compared to patients with dry AMD.~   "
216369|NCT00727350|"~     The study population will exist of patients with a histological diagnosis of NSCLC, stage T1,~     T2 or T3NO who are not fit for or who refuse surgery. A prospective data analysis will be~     performed on tumor response, potential acute and late toxicity and survival. A radiotherapy~     dose of 4x15Gy or 3x 20Gy will be given over 2 weeks with dynamic 3D-conformal arc therapy~     (Novalis TM)~   "
249942|NCT00280852|"~     To describe the outcome of patients with anaplastic thyroid cancer treated with~     hyperfractionated radiotherapy and concomitant chemotherapy~   "
216340|NCT00727740|"~     The purpose of this research study is to determine if indomethacin, an anti-inflammatory~     medication in a class of medications known at NSAIDs (non-steroidal anti-inflammatory drugs)~     can reduce the risk of pancreatitis after Endoscopic Retrograde Cholangio-Pancreatography~     (ERCP.) The hypothesis is that indomethacin decreases the incidence and severity of post-ERCP~     pancreatitis. Patients who are scheduled to undergo a ERCP will be enrolled. Following ERCP,~     patients will be randomized to receive a dose of indomethacin or placebo (an inactive~     substance) instilled into the duodenum via the biopsy channel of the duodenoscope. All~     patients will be observed for 4 hours following ERCP which is part of routine clinical~     practice. Patients with minimal pain will be discharged after this 4 hour observation period.~     All patients will have baseline serum amylase levels which are repeated 2 to 4 hours after~     the ERCP has been completed. Patients who have significant abdominal pain will be~     hospitalized and evaluated for pancreatitis. Patients discharged to home will be contacted by~     telephone the following day to ask them if they have had any complications of ERCP.~   "
216341|NCT00727727|"~     The objective of the Post Marketing Surveillance Study is to investigate the use of the~     non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy~     in patients with Morbus Parkinson. Neurologists in private practices in Germany should~     document the safety and course of the disease/change of parkinsonian symptoms during~     stabilisation on, or change over from other dopamine agonist treatment under routine~     conditions. Piribedil should be prescribed according to its marketing authorisation.~   "
216342|NCT00727714|"~     The aim of the study is to examine possible changes in lung function, nitric oxide levels and~     systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).~   "
216343|NCT00727701|"~     The purpose of this study is to determine whether individualized wound prevention~     instructions will lengthen the ulcer-free period in veterans with recently healed venous~     ulcers.~   "
216344|NCT00727675|"~     This study involves the development of an integrated psychotherapy that addresses both~     chronic pain and opioid dependence(POD).~   "
216345|NCT00727662|"~     This randomized controlled trial will compare the effectiveness of an Iyengar Yoga~     intervention to a Wellness Seminar health education lecture series, for improvements in~     energy, mood and biological functioning in breast cancer survivors with persistent,~     post-treatment fatigue. It is anticipated that the Iyengar Yoga intervention will be feasible~     and acceptable to breast cancer survivors with minimal side effects and that the Yoga~     intervention will be effective in improving fatigue and physical performance.~   "
216346|NCT00727649|"~     The purpose of this study is to evaluate and compare treatment with fiber and loperamide for~     fecal incontinence.~   "
216347|NCT00727636|"~     Many IBD patients take immunosuppressive agents and we are uncertain as to their capacity to~     mount a truly protective response after vaccination. If IBD patients do not have an adequate~     immunological response, they may need to increase the dosage or get booster shots. Many~     clinicians who treat patients with autoimmune diseases are asking if the vaccine is safe and~     effective. Thus, this study has important clinical and public health significance because~     more than one million people in the United States have been diagnosed with IBD.~      There is not much studied about HPV and immunocompromised patients. Research on healthy women~     who were immunized with a set of three HPV vaccines demonstrated significantly increased~     antibody titers. In addition, they had significantly reduced HPV incident and persistent~     infection and HPV-related disease (cervical, vulvar, and vaginal cancers, cervical~     intraepithelial neoplasia, genital warts) through five years of follow-up compared to~     controls who received a placebo. The HPV vaccine was well tolerated without significant side~     effects.~      The aims of this research are to measure the immune response in 9-26 year old IBD patients~     who are on immunosuppressive agents after receiving the HPV vaccine compared with historical~     controls. We will also evaluate the number and type of vaccine-associated adverse events as~     well as the disease activity and flare-ups that occur after each dose of vaccine. We~     hypothesize that IBD patients on immunosuppressive therapy will have have a similar immune~     response to HPV types 6, 11, 16 and 18 at one month postdose 3 compared to healthy~     age-matched historical controls.~      The patient population includes IBD patients who are on immunosuppressive medications.~     Recruiting approximately 100 patients will provide adequate power for the study. A blood~     sample will be taken from all IBD patients to evaluate baseline antibody levels and markers~     (e.g., ESR, CBC, albumin) before or immediately after immunization with the HPV vaccine. Lab~     tests will be redrawn at 7 months to evaluate the level of antibody titers and follow the~     markers. During the study, we will track basic laboratory measures, disease status by using~     the Pediatric Crohn's Disease Active Index or Harvey-Bradshaw Index for UC, side effects from~     the vaccinations, and other adverse events.~   "
216348|NCT00727623|"~     The purpose of this observational study is to assess predictors of in-hospital mortality in~     patients with acute myocardial infarction admitted to Belgian hospitals.~   "
216349|NCT00727610|"~     Adverse Drug Related Events (ADREs) are a leading cause of Emergency Department (ED) visits~     in Canada. However emergency physicians recognize only half of all ADREs in patients~     presenting to the ED, missing opportunities to intervene. The objective of this study is to~     develop a screening strategy that identifies patients with ADREs. Our hypothesis is that the~     development of a user-friendly, reliable screening strategy for ADREs in patients presenting~     to the ED is feasible. We believe that this will lead to improved patient care.~   "
216350|NCT00727597|"~     The hope of this study is to gather data and information about the tolerability and~     effectiveness of Lexiva versus Sustiva in patients who have have been generally~     underrepresented in clinical trials.~   "
216351|NCT00727584|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known~     which radiation therapy regimen is more effective in treating metastatic spinal cord~     compression.~      PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see~     how well they work in treating patients with metastatic spinal cord compression.~   "
216352|NCT00727571|"~     This is a prospective, multicenter, observational, hypothesis-generating study exploring~     mobility, Quality of Life and other physical performance measures among older, long-term stay~     Nursing Home residents with CKD, with versus without anemia. Enrolled patients will~     participate in the study up to a total of 26 weeks and be assessed at Weeks 1, 2, 14 and~     26/End of Study. Based upon Week 1 hemoglobin and serum creatinine lab results, participants~     will be categorized into 1 of 4 groups.~   "
216353|NCT00727558|"~     This study seeks to evaluate the clinical performance of a new CE marked daily disposable~     contact lens that contains a wetting agent to a recently improved daily disposable contact~     lens.~   "
216370|NCT00727337|"~     The study is designed to examine the effectiveness of a computer-based auditory training~     program to improve the benefits received by individuals who wear hearing aids. The study will~     involve 3 groups - a computer-based training group, an active listening group which will~     involve listening to books on CD, and a placebo group that receives no additional treatment.~   "
216354|NCT00727545|"~     This was a double-blind community-based trial, placebo controlled. During 16 weeks, children~     in the intervention group (GI, n=180) received iron fortified rice, and children in the~     control group (GC, n=174) received rice with placebo. Anemia was considered present when~     hemoglobin < 11.0g/dL. Comparison of mean variation on hemoglobin between groups was accessed~     by using Student's t-test. Hemoglobin concentration improved in both groups, with mean~     increase of 0.42 g/dL in GI (11.28±1.23 g/dL to 11.75±1.16 g/dL, p < 0.001), and 0.49 g/dL in~     GC (11.06±1.13 g/dL to 11.51±1.16 g/dL, p < 0.001). Anemia decreased (p < 0.01) in both~     groups (37.8% to 23.3% in GI and 45.4% to 33.3% in GC), with no differences between them.~     Hemoglobin increase was significantly higher in children who received total amount of iron ≥~     53.76 mg from fortified rice, compared to those who received less than this cut-off value~     (0.94 g/dl vs 0.39 g/dl p=0.03). The results suggest that this type of intervention can be~     useful in anemia control if fortified food intake is adequate.~   "
216355|NCT00727532|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This clinical trial is studying how well sorafenib works in treating patients with~     locally advanced or metastatic kidney cancer.~   "
216356|NCT00727519|"~     Pomegranate juice (PJ) consumption by hemodialysis patients will reduce the oxidative stress~     and the incidence of infections, cardiovascular events and mortality.~   "
216357|NCT00727506|"~     Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992~     administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade~     III and IV).~      Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 /~     TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with~     recurrent GBM. To evaluate molecular determinants of response to BIBW 2992.~   "
216358|NCT00727493|"~     The purpose of this study is to evaluate the influence of alendronate therapy on the wound~     healing after dental implants in patients with osteoporosis.~   "
216359|NCT00727480|"~     The purpose of this study is to develop a small, easily used device to detect a person's~     blood flow in their fingertips.~   "
216360|NCT00727467|"~     The primary aim of the study is to evaluate the effect of an IACD i.e. Apple iPod-shuffle, on~     freezing and gait speed in people with a diagnosis of PD through the implementation of a~     randomised controlled trial. A secondary aim of the study is to evaluate the impact of such a~     device on the quality of life of people with stroke through the administration of a~     self-report questionnaire. The IACD will be pre-loaded with an individualised auditory cueing~     frequency (metronome sound) matched to the walking speed of the individual with PD.~   "
216361|NCT00727454|"~     Obstructive sleep apnea (OSA) is independently associated with important heart remodeling~     that further contributes to overt heart failure. Recent evidences using echocardiogram~     suggested that continuous positive airway pressure (CPAP) has beneficial effects mainly on~     left ventricle parameters. However, the evidences regarding the right ventricle are scanty.~     In addition, no previous studies evaluated morphological and functional characteristics in~     OSA by magnetic resonance imaging (MRI) as well as the impact of CPAP.~   "
216362|NCT00727441|"~     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective~     immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving vaccine therapy together with~     cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is~     more effective with or without cyclophosphamide in treating patients with pancreatic cancer.~      PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and~     to see how well it works when given with or without cyclophosphamide in treating patients~     undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that~     can be removed by surgery.~   "
216363|NCT00727428|"~     The present study is intended to assess a novel formulation of FluLaval. The idea is to~     obtain preliminary data on the safety and immune response to the FluLaval TF influenza~     vaccine in adults. These data will serve as a basis for further studies involving different~     populations. This protocol posting deals with objectives & outcome measures of the primary~     phase/study.~   "
216364|NCT00727415|"~     This is a phase I - II multicenter, non-comparative, open label study in patients with~     previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with~     Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination with~     the MTD of Lenalidomide (FCL).~   "
216365|NCT00727402|"~     The LASH Contact Lens Study is a prospective longitudinal study of silicone hydrogel (SH)~     contact lens wearers who sleep in their lenses for up to 29 consecutive nights (30 days) of~     continuous wear (CW), with monthly disposal. Up to 207 healthy nearsighted or farsighted~     patients with minimal or no astigmatism and no contraindications to CW lens use will be~     followed for 1 year. The primary outcome measure is the time to development of a corneal~     inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main~     exposure of interest is corneal staining. Other key exploratory variables include bacterial~     contamination of study lenses and inflammatory mediators found in the tear film.~   "
216366|NCT00727389|"~     The objective of this study is to evaluate the capacity of muscular function and articular~     amplitude in the aged women who participated in the Support Group and its influence on the~     prevention of function decline of these women.~   "
216367|NCT00727376|"~     To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during~     radiation and/or chemotherapy treatment.~   "
216368|NCT00727363|"~     This study tries to determine whether the oral administration of a specific probiotic (good~     bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent~     infections and the development of a severe inflammatory disease of the bowel called~     necrotizing enterocolitis. The investigators propose that premature infants not given~     probiotics will colonize their gut with bad bacterias and develop infection.~   "
216900|NCT00720252|"~     The purpose of this study is to measure prenatally with ultrasound the intratracheal flow~     volume displaced during breathing cycle in premature fetuses and to check whether a~     relationship exists between the inspired fluid and fetal lung maturation.~   "
216371|NCT00727324|"~     Ulcerative colitis is characterized by abnormal activation of, and damage to, the colon~     epithelium, which is considered to be a central pathogenic mechanism. Activation of colon~     epithelium cells in UC is associated with an abnormal high expression of Toll-like receptors,~     including TLR-4, the major transducer of LPS, binding specifically the lipid A portion of~     LPS. Alkaline Phosphatase binds and subsequently dephosphorylates LPS, thereby eliminating~     the ability of LPS to activate TLR-4. This is expected to 1) prevent activation of the~     intestinal epithelium and 2) prevent systemic inflammatory responses that result from~     transmigration of endotoxin though the leaky inflamed intestinal mucosa. Therefore, it is~     expected that administration of BIAP may attenuate or prevent the local and systemic~     inflammatory response in patients with severe ulcerative colitis.~   "
216372|NCT00727311|"~     The objective of the study is to assess the safety and efficacy of PegIntron injector and~     Rebetol administered to participants with chronic hepatitis C. Participants will be treated~     by general practitioners in clinical practice as part of the post-marketing surveillance~     study. The study will assess the rates of eradication of the hepatits C virus and the rates~     of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200~     mg/day) in common medical practice in Germany.~   "
216373|NCT00727298|"~     This study will be performed to evaluate and document the safety and efficacy of infliximab~     (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily~     routine practice of rheumatologists, gastroenterologists, and dermatologists.~   "
216374|NCT00727285|"~     Presently, effectiveness of treatments for CF lung disease is judged by improvement in lung~     function (FEV1). However, in CF patients, FEV1 can range from severely decreased to normal,~     and improvements may occur slowly. Thus, clinical trials require many patients over prolonged~     periods to evaluate medications. As the pace of drug development accelerates, it is no longer~     possible to test all of the promising candidate therapies using conventional study designs. A~     sensitive technique for assessing lung inflammation has been developed which uses the~     expression of genes located in circulating blood cells. Mononuclear cells pass repeatedly~     through the blood vessels of the lung, and are exposed to many of the inflammatory products~     that are present in the airways. Over the past 4 years the investigators have identified a~     small group of candidate genes that are unregulated or downregulated in response to~     antibiotic treatment. The investigators now propose to prospectively test this method of~     quantifying lung inflammation in a large group of CF patients undergoing treatment of~     pulmonary exacerbations. Blood will be sampled before and after antibiotic treatment for a~     pulmonary exacerbation, and the relative change in gene expression will be compared to~     improvement in FEV1 and other clinical responses, to determine the utility of this method for~     use in studies. If successful, this technique could allow for a rapid and noninvasive method~     to gauge immediate effects by new treatments, and assist caregivers in determining optimal~     treatment strategies for the individual.~   "
216375|NCT00727272|"~     The purpose of this study is to evaluate and compare the relative bioavailability of Quinine~     Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine~     Sulphate 300 mg tablets, manufactured by the Government Pharmaceutical Organization, Bangkok~     Metropolis, Thailand, after single oral dose administration under fasting conditions. An~     additional purpose of this study is to evaluate the effect of food on the Mutual~     Pharmaceutical Company product.~   "
216376|NCT00727259|"~     The current gold standard for treatment of chronic hepatitis C (CHC) patients is with~     pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will~     definitely determine treatment effectiveness. This is the idea behind the development and~     usage of the PegPen. The goal of this study is to determine the satisfaction grade with this~     novel device.~   "
216377|NCT00727246|"~     The purpose of this study is to determine whether an investigational drug, called~     CDP-Choline, improves memory in people with traumatic brain injury (TBI). To do this, we~     are asking for people with traumatic brain injury and people without traumatic brain injury~     to be a part of this study. We will compare results between each group to see if this~     investigational drug makes a difference with memory. We will also compare brain imaging~     results and information collected before and after the taking of the study medication to see~     if there are any differences. We hypothesize that there will be differences in brain~     activation patterns between individuals with TBI and healthy controls, as well as differences~     in performance on memory testing at baseline. We further hypothesize that, after treatment~     with CDP-Choline, the patterns in neuroimaging findings and cognitive testing results for~     individuals with TBI will more closely resemble results observed for healthy individuals. We~     hope that what we learn from this study will be helpful in the future treatment of~     individuals with head injury.~   "
216378|NCT00727233|"~     Background:~      Patients with neurofibromatosis type 1 are at increased risk of developing tumors called~     plexiform neurofibromas (PN) that arise from nerves. These tumors are usually non-cancerous,~     but they can cause serious medical problems.~      Sorafenib was recently approved to treat patients with kidney cancer and is now being tested~     in children with cancer. It affects several pathways thought to be important for the~     development and growth of PN and may therefore shrink these tumors or slow their growth.~      Objectives:~      To determine the highest dose of sorafenib that can safely be given to children and young~     adults with PN.~      To identify the side effects of sorafenib in these patients.~      To study how the body handles sorafenib by measuring the amount of drug in the bloodstream~     over time~      To determine how the drug affects blood flow and blood cells and proteins.~      To determine if sorafenib can shrink or slow the growth of PN.~      To determine the effects of sorafenib on learning, attention, memory, and quality of life.~      Eligibility:~      Patients between 3 and 18 years of age with NF1 who have inoperable PN that can cause~     significant disability.~      Design:~      Patients take sorafenib tablets twice a day in 28-day treatment cycles. They may continue~     treatment until their tumor grows or they develop unacceptable drug side effects. In this~     dose escalation study, the dosage is increased with every 3 to 6 children who are enrolled~     until the highest safe dose is determined. In any case, the dose will not exceed that used in~     children with cancer.~      Patients are monitored regularly with physical examinations, blood and urine tests, MRI scans~     and quality-of-life questionnaires.~      Patients whose bones are still growing have periodic x-rays of the hips and lower legs to~     monitor for possible changes in the structure of growing bones.~      Patients have periodic tests of learning and memory before starting treatment and before~     cycles 4, 12, 18 and 24.~      Patients have pharmacokinetic studies to examine how the body handles sorafenib. blood~     samples are drawn before the first dose of sorafenib and then at 30 minutes, 1 hour, 2 hours,~     3 hours, 5 hours, 8 hours, 10 to 12 hours, 24 hours and 30 to 36 hours following the first~     dose.~   "
216392|NCT00727051|"~     The overall goal of this study is to determine if non-invasive imaging with state of the art~     CT coronary angiography can be used to screen for coronary artery disease in high risk~     patients prior to liver and lung transplantation. The current protocol for coronary artery~     disease assessment at UCSF before liver and lung transplantation involves screening with~     stress tests and/or coronary angiograms in patients with increased risk of coronary artery~     disease. Coronary angiogram will be used as gold standard for assessment of coronary CTA~     accuracy.~   "
216379|NCT00727220|"~     The purpose of the study is to examine glycemic and neuropsychological outcomes in very young~     children with Type I diabetes who are being started on insulin pumps and to compare their~     outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children~     with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections~     with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be~     examined prior to and 12 months after the implementation of insulin pump therapy. These~     subjects will be recruited and followed because they are currently undergoing treatment for~     Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and~     their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not~     be changed by the study team. Outcome measures will examine: glycemic outcomes (overall~     control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.~   "
216380|NCT00727207|"~     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well everolimus works in treating older patients~     with mantle cell lymphoma who received previous first-line or second-line chemotherapy.~   "
216381|NCT00727194|"~     The purpose of this study is to determine whether eculizumab is safe and effective in the~     treatment of patients with generalized myasthenia gravis despite treatment with various~     immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and~     cyclophosphamide, that are currently available.~   "
216382|NCT00727181|"~     This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve~     by establishing associated adverse event rates, clinical status as indicated by New York~     Heart Association (NYHA) functional classification, hemodynamic performance, and hematology~     analysis.~   "
216383|NCT00727168|"~     The purpose of this study is to study the prevalence of glaucoma in Korea, the investigators~     selected Namil area in Geumsan city, located in central Korea. The residents aged over 40 in~     this area are to be recruited to full ophthalmologic examination to detect and classify the~     glaucoma.~   "
216384|NCT00727155|"~     Medically ill patients with Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary~     Disease (COPD) are at increased risk for developing symptoms of anxiety and depression and~     are among the least frequent users of mental health services and treatments. To address the~     needs of chronically ill patients, we created a time-limited psychosocial intervention to~     maximize treatment benefits and improve the efficiency and ability of mental health care~     practitioners to provide services within medical care settings. This study is separated into~     two randomized study groups. The first group of participants will receive the ACCESS~     intervention immediately. The second group of participants will be followed for a period of 6~     months. After a period of 6 months, those who continue to have symptoms of depression and/or~     anxiety will be offered the ACCESS intervention.~   "
216385|NCT00727142|"~     This study aims to provide class 1 evidence supporting or refuting the existence of normal~     pressure hydrocephalus.~   "
216386|NCT00727129|"~     The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for~     postmenopausal patients.~   "
216387|NCT00727116|"~     This project is designed to evaluate a statewide, hospital-based parent education program to~     prevent abusive head trauma (AHT) in Pennsylvania, and investigate the additional~     effectiveness and cost-effectiveness of booster sessions of parent education delivered to~     parents at primary care provider offices in central Pennsylvania.~      Specific Aims:~        1. Assess the effectiveness of an established statewide program of hospital-based postnatal~          parent education about violent infant shaking, provided at a single consistent point in~          time between the infant's birth and hospital discharge, in reducing the incidence of~          AHT.~        2. Identify which component(s) are the most important mediators of the intervention's~          effectiveness; determine whether the intervention effect is more directly related to~          changes in perpetrator or caregiver behavior; and determine the effectiveness of the~          intervention among various socioeconomic groups.~        3. Determine the cost effectiveness of the hospital-based program.~        4. Establish the feasibility, additional costs, and effectiveness of a combined program of~          repeated exposure delivered both post-natally in the hospital and during follow up 2-,~          4- and 6-month outpatient health maintenance visits with the pediatric care provider.~   "
216388|NCT00727103|"~     The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment~     decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder.~     Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g.~     poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with~     schizophrenia and comorbid nicotine and alcohol dependence.~   "
216389|NCT00727090|"~     Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia),~     but there are few data in patients with neurologic disease. Very low serum sodium in patients~     with brain injury can be life-threatening and is associated with cerebral edema (swelling of~     brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or~     stroke (cerebral infarction).~      This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater~     increase in sodium than usual care. Patients will be randomly assigned to usual care or the~     lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other~     interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics~     and salt tablets. A blinded co-investigator will record neurologic examination results (NIH~     Stroke Scale and Glasgow Coma Scale).~   "
216390|NCT00727077|"~     The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3~     times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common~     medical practice at 10 sites in Germany. The primary objective is to determine if there are~     any new severe adverse events observed with this recently approved dosing regimen. The study~     will also evaluate the rates of eradication of the HCV virus.~      This study was terminated due to low enrollment. At the time of termination, 3 participants~     had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and~     will be included in the P04538 (NCT00727077) data reporting.~   "
216391|NCT00727064|"~     The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK)~     between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with~     desvenlafaxine SR and venlafaxine ER when a single dose is administered.~   "
216393|NCT00727038|"~     Neovascular glaucoma is a potentially debilitating disease of the eye. Vascular eye disease~     such as diabetes and vein occlusions can cause the retina to release factors that promote the~     growth of abnormal blood vessels. These abnormal vessels can grow in the drainage mechanism~     of the eye causing pressure in the eye to markedly increase. This can potentially cause~     irreversible damage to the optic nerve from glaucoma leading to permanent blindness and~     painful eyes. Conventional treatments including laser and freezing therapy take weeks to~     cause regression in abnormal blood vessel growth. This delay often results in permanent~     vision loss and pain. New medications targeted at more immediately reducing blood vessel~     growth may aid in the treatment of this disease.~   "
216394|NCT00727025|"~     Purpose: The aims of this randomized clinical trial are:~        1. to assess scar quality from the patient and surgeon perspectives~        2. to assess patient comfort in the days immediately following surgery~        3. to assess the time taken to complete closure in the operating room.~        4. the financial benefit or cost for the institution of using Steri Strip S will also be~          estimated.~      Two closure methods will be compared, a new coaptive film device (Steri Strip S) versus~     standard subcuticular sutures. The linear incisions will include the standard incision~     segments utilized for an inverted-T closure for bilateral breast reduction and the~     transabdominal incision segments utilized for abdominoplasty or TRAM flap harvest.~      Our hypothesis is that incisions segments closed with Steri Strip S compared to standard~     subcuticular closure, will yield scars of better cosmetic quality, in shorter time to~     closure, with novice and expert surgeons, for both bilateral breast reduction and~     abdominoplasty surgical procedures.~   "
216395|NCT00727012|"~     This clinical study is a multicenter, prospective non-randomized observational study without~     concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will~     be included. The primary objective of the study is to demonstrate the effectiveness of the~     SJM® Rigid Saddle Ring when used in mitral valve repair procedures.~   "
216396|NCT00726999|"~     Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg~     three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine~     and placebo group with similar pills, also PCA morphine. The goal is to measure morphine~     usage and incidence of morphine side effects (pruritis, days foley, days to first stool,~     sedation, pain scores, PCA use).~   "
216397|NCT00726986|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving sorafenib together with~     combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving sorafenib together with cisplatin~     and etoposide works in treating patients with extensive-stage small cell lung cancer.~   "
216398|NCT00726973|"~     The purposes of this study is to determine if combination reduced fluence photodynamic~     therapy and Ranibizumab has:~      Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number of~     intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number~     of PDT treatments. The study will also collect information on the safety of combination~     therapy and single therapy.~   "
216399|NCT00726960|"~     The objective of this study is to determine whether aprepitant blocks the opiate reward~     system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive~     first line therapy for early heroin abuse.~   "
216400|NCT00726947|"~     The purpose of this study is to see if the investigators can use ultrasound imaging to~     determine the type of clots in patients to help better manage their care.~   "
216401|NCT00726934|"~     The purpose of this study is to determine if FDA approved food safety guidelines are~     equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of~     infections during neutropenia in a sample of pediatric cancer patients.~   "
216402|NCT00726921|"~     This study investigates hypothesizes that the combination of dobutamine stress~     echocardiography with dobutamine stress echocardiography with real time perfusion myocardial~     contrast echocardiography and coronary computed tomography is a better modality for detecting~     coronary artery disease in end-stage renal disease patients than coronary angiography, and in~     predicting patient outcomes. Demonstrating this would lead to increased use of DSE with RTCE~     and coronary CT at kidney transplant centers throughout the nation, leading to improved~     anatomical and functional detection of CAD without the need for further invasive procedures.~   "
216403|NCT00726908|"~     High levels of the hormone insulin are associated with risk for heart disease and diabetes,~     and may make it hard to lose weight. The types of food eaten may affect insulin levels. The~     purpose of this study is to determine if manipulation of dietary carbohydrate content~     improves insulin sensitivity (Si), augments weight loss, and promotes weight loss maintenance~     in healthy adults.~   "
216404|NCT00726895|"~     The purpose of this study is to evaluate and compare the dose proportionality of 324 mg~     Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg~     capsules) in healthy adult volunteers when administered under fasting conditions.~   "
216405|NCT00726882|"~     The purpose of this follow-up study is to evaluate the frequency and persistence of specific~     viral mutations in response to treatment with ABT-333 (dasabuvir).~   "
216406|NCT00726869|"~     This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate~     the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior~     therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV)~     infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes~     following the administration of bortezomib at 1.3 mg/m^2 IV bolus. Bortezomib will be given~     in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest~     period). Elotuzumab will be administered as a separate infusion within 30 minutes following~     bortezomib administration on the same days as the first and last dose of each bortezomib~     cycle (i.e., Days 1 and 11).~   "
216407|NCT00726856|"~     This retrospective study evaluates the effectiveness and safety of ezetimibe plus statin or~     ezetimibe plus fenofibrate in dyslipidemic patients that were treated with these dual~     inhibition lipid lowering regimens as part of their normal standard of care. This study~     assesses the percentage of patients who achieve LDL-C target goals and also evaluates the~     patient compliance to treatment.~   "
216408|NCT00726843|"~     This study will examine the feasibility and acceptability of yoga for adolescents seen by a~     medical practitioner for their headaches. The study will also examine whether yoga decreases~     anxiety and improves quality of life. We hypothesize that yoga will be both acceptable and~     feasible with a pediatric population. We also hypothesize that yoga will decrease anxiety and~     improve quality of life.~   "
216409|NCT00726830|"~     RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is~     not yet known whether methadone is more effective than morphine or oxycodone in treating pain~     in patients with cancer.~      PURPOSE: This randomized clinical trial is studying methadone to see how well it works~     compared with morphine or oxycodone in treating pain in patients with cancer.~   "
216410|NCT00726817|"~     During this double blind, placebo controlled, randomised cross over study, healthy volunteers~     received an enema once daily for one week containing either placebo (saline), 50mM butyrate~     or 100mM of butyrate. Before and directly after each test period a barostat protocol was~     performed to measure parameters for visceral perception.~   "
216411|NCT00726804|"~     Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine~     and sacroiliac joints. In most of the patients disease activity alternates, and some patients~     have symptom free periods. Tumor-Necrosis-Factor-alpha (TNF-alpha) antagonists have~     significantly improved the treatment options for patients with spondyloarthritis. TNF-alpha~     antagonist therapy is costly, implies an increased risk of infections, including reactivation~     of tuberculosis, and the risk of long-term adverse events, as cancer, is fully clarified. It~     is highly relevant to explore to which extent anti-TNF-alpha therapy can be discontinued in~     SpA patients without immediate relapse of disease activity. Two studies have investigated~     discontinuation of a TNF-alpha antagonist (infliximab and etanercept) in ankylosing~     spondylitis, reporting flares in the majority of patients within the 1-year follow-up period,~     with the longest times to relapse in patients with the lowest disease activity. The effect of~     adalimumab discontinuation has never been studied, and, furthermore, the effect of~     TNF-alpha-antagonist discontinuation has never been studied in patients with early~     spondyloarthritis not fulfilling the New York criteria.~   "
216412|NCT00726791|"~     Chronic somatoform pain is common in psychiatric patients. Chronic somatoform pain causes~     significant distress and disrupts social functioning. Moreover, chronic somatoform pain often~     does not sufficiently respond to medication.~      Chronic somatoform pain is associated with medial pain system. The medial pain system is~     comprised of structures engaged in affect and motivation, such as medial thalamus and limbic~     structures. The medial pain system gets inhibitory control from motor cortex. Functional~     neuroimaging studies indicate that chronic somatoform pain is associated with hypoactivity of~     motor cortex, defective inhibitory process, and hyperactivity of medial pain system.~      Repetitive Transcranial Magnetic Stimulation (rTMS) is a safe and non-invasive tool to~     modulate neurophysiologic activity of the focal brain. Therefore, pain relief by rTMS can be~     obtained from motor cortex stimulation, restoration of defective inhibitory process, and~     deactivation of medial pain system. Studies have shown that motor cortex stimulation using~     rTMS can relieve pain in patients with neuropathic pain. However, to our knowledge, there is~     no rTMS study on chronic somatoform pain in psychiatric patients. The purpose of this study~     is to evaluate the effect of motor cortex rTMS on chronic somatoform pain.~   "
216413|NCT00726778|"~     The main objective of this study is to investigate the effect of genetic and environmental~     parameters on racial/ethnic differences in aspects of insulin secretion and action. The~     genetic component will be modeled by estimating the degree of European genetic admixture~     (ADM) obtained from approximately 50 ancestry informative markers (AIMs). The environmental~     components will be modeled by measuring energy intake (food intake), energy expenditure~     (physical activity) and socioeconomic status.~   "
216414|NCT00726765|"~     This is a multi-national, multi-site, observational study to determine which of two~     strategies, when used by referring physicians is superior in the diagnosis of axial~     spondyloarthritis (AS) by rheumatologists.~   "
216415|NCT00726752|"~     This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses~     and multiple doses~   "
216416|NCT00726739|"~     RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may~     help the body build an effective immune response to kill tumor cells. Giving aldesleukin~     together with vaccine therapy may kill more tumor cells. It is not yet known whether~     aldesleukin is more effective with or without vaccine therapy in treating melanoma.~      PURPOSE: This randomized phase II trial is studying how well aldesleukin works when given~     with or without vaccine therapy in treating patients with stage IV melanoma.~   "
216417|NCT00726726|"~     The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics~     of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and~     dextromethorphan~   "
216418|NCT00726713|"~     The purpose of this research study is to determine if Metanx improves sensory neuropathy in~     persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a~     physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which~     are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be~     randomly assigned to receive either Metanx or placebo for 6 months.~   "
216419|NCT00726700|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and~     vincristine, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim,~     may increase the number of immune cells found in bone marrow or peripheral blood and may help~     the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such~     as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them~     or carry cancer-killing substances to them. Others interfere with the ability of cancer cells~     to grow and spread. It is not yet known whether combination chemotherapy and pegfilgrastim is~     more effective when given with or without rituximab in treating non-Hodgkin lymphoma.~      PURPOSE: This phase II trial is studying the side effects of giving pegfilgrastim and~     combination chemotherapy together with or without rituximab and to see how well it works in~     treating older patients with aggressive B-cell non-Hodgkin lymphoma.~   "
216420|NCT00726687|"~     This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid~     tumors.~   "
216422|NCT00726661|"~     This is a multicenter, prospective observational cohort study (OCS) designed to follow~     patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts~     will be included:~        -  Patients with human epidermal growth factor receptor 2-negative (HER2-negative) disease~          receiving their first cytotoxic chemotherapy and/or targeted therapy (approximately 825~          patients)~        -  Patients with hormone receptor-positive (HR-positive) disease receiving their first~          hormonal therapy for advanced disease (approximately 425 patients)~      Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to~     enrollment to this OCS will not be eligible. A total of approximately 1,250 patients will be~     enrolled. Approximately 150 study sites will be activated in order to achieve complete~     enrollment by December 2010.~   "
216423|NCT00726648|"~     Comparison of the effects of different CDP323 doses given over a period of four weeks on~     blood biomarkers in subjects with relapsing forms of multiple sclerosis.~   "
216424|NCT00726635|"~     The purpose of this study is to asses the impact of a tailored preoperative psychological~     intervention on women with gynecological malignancies on psychological, physiological and~     immunological parameters~   "
216425|NCT00726622|"~     This study is being done to compare two types of surgery currently used for rectal cancer.~     The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy~     rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal~     cancer in some medical centers, the effectiveness of this type of surgery compared to open~     surgery is unknown. The study will compare the safety and effectiveness of the surgeries,~     recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.~   "
216426|NCT00726609|"~     The purpose of this postmarketing surveillance study is to collect an extensive body of data~     in a large patient population in every day life to investigate the safety and efficacy of~     NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.~   "
216427|NCT00726596|"~     This phase II trial studies how well hydroxychloroquine works in treating patients with~     previously treated prostate cancer. Autophagy destroys proteins and other substances in cells~     and may be used by prostate cancer cells to survive. Hydroxychloroquine, which blocks~     autophagy, may slow the growth of and possibly kill prostate cancer cells.~   "
216428|NCT00726583|"~     This study is being conducted to determine the safety and maximally tolerated dose of PX-866~     when given orally on two different schedules: daily on days 1-5 and 8-12 of a 28 day cycle~     and daily on days 1-28 of a 28 day cycle.~   "
216429|NCT00726570|"~     This study aims to assess possible alteration in coagulation (blood clotting) following~     treatment with sequential compression devices (SCD) plus low-molecular weight heparin (LMWH)~     as opposed to LMWH alone.~      The investigators will examine coagulation in the early postoperative period of patients~     undergoing major abdominal surgery during their stay in our Intensive Care Unit.~      In addition to common laboratory tests, the investigators will examine coagulation using~     TEG®, a device which allows a semi-quantitative examination of all phases of coagulation.~   "
216430|NCT00726557|"~     Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy~     (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the~     approved European labeling. The study will assess the tolerability, safety and efficacy of~     the treatment with PegIntron plus Rebetol in this study population. The objective of the~     study is to collect data on the prevalence of the hepatitis C infections in drug-substituted~     patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in~     patients receiving Subutex® vs other drug substitution pharmacotherapies.~   "
216431|NCT00726544|"~     The purpose of this ascending-dose research study is to determine whether the administration~     of ARC1779 Injection improves subject's health profile by protecting the brain, heart, and~     kidney from damage due to formation of small blood clots in blood vessels. It will also~     determine the safety of ARC1779 Injection, how ARC1779 Injection enters and leaves the blood~     and tissue over time, and its effect on laboratory tests related to blood clotting, heart and~     brain function, and other body systems.~   "
216432|NCT00726531|"~     The aim of the project is to evaluate the delivery, impact and cost effectiveness of a~     community based exercise programme (FaME); compared to a home based exercise programme (OEP)~     supported by similarly aged mentors; compared with usual care for primary care patients.~      Primary Objective:~        1. To determine the effect on continuation of exercise of two evidence based exercise~          programmes designed for older people, compared with usual care i.e. with no special~          interventions to promote physical activity.~           Secondary Objective:~        2. To determine the health benefits of the programmes to patients starting at various~          levels of physical activity, particularly the effects on physical and psychological~          status, health status and quality adjusted life years (QALYs).~        3. To estimate the costs of the exercise interventions and to assess the cost-effectiveness~          of community group exercise, and home-supported exercise compared with usual care.~        4. To determine the acceptability of the programmes, adherence rates, enabling factors and~          barriers to future implementation.~        5. To determine participants' perceptions of the value of exercise, and the predictors of~          continued exercise.~   "
216433|NCT00726505|"~     The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss~     in urine in healthy subjects and subjects with type 2 diabetes mellitus~   "
216434|NCT00726492|"~     Osteoarthritis, a common disorder increasing in prevalence with advancing age, is~     particularly debilitating when the knees are affected. This study examined the value of~     hydrotherapy (exercise in water) and continuous short-wave diathermy (an electrical deep heat~     treatment) for the relief of osteoarthritic symptoms.~   "
216435|NCT00726479|"~     The primary objective of this study is to investigate the effect of 4-week treatment with 7.5~     mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS and placebo on cough and sputum as~     determined by the CASA-Q (Cough and Sputum Assessment Questionnaire~   "
216481|NCT00725842|"~     The objective of this study is to determine the relapse rate in the French patient population~     with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN~     alfa-2b) plus Ribavirin according to standard clinical practice. Treatment was to be~     completed prior to the enrollment in the current study. The study will also aim to identify~     factors that are predictive of relapse. Relapse rate is defined as the percentage of patients~     with negative viral load at end of treatment who again have positive viral load at 6 months~     after the end of treatment.~   "
216436|NCT00726466|"~     Efalizumab is an immunosuppressive recombinant humanized IgG1 monocolonal antibody (150 Kd)~     that binds to human CD11a (1) and is used for the treatment of plaque psoriasis. Efalizumab~     was derived from the humanization of the murine efalizuman monoclonal antibody MHM24, which~     recognizes human and chimpanzee CD11a. Humanization of MHM24 was accomplished by grafting the~     murine complementarity determining regions (hypervariable region) into consensus human IgG1/~     heavy and light chain sequences (Werther et al 1996). These same consensus human~     immunoglobulin sequences have been successfully used in the humanization of other murine~     antibodies, including those targeted to HER2 and IgE. Efalizumab inhibits the binding of~     LFA-1 to intercellular adhesion molecule-1 (ICAM-1) thereby inhibiting the adhesion of~     leukocytes to other cell types.~      Ranibizumab is a recombinant, humanized, Fab fragment of a mouse monoclonal antibody targeted~     against VEGF. As VEGF binds to cellular receptors, it stimulates angiogenesis and vascular~     leakage. Blockade of VEGF by ranibizumab leads to reduced stimulation of cell proliferation~     and permeability resulting in inhibition of angiogenesis and decreased leakage. Ranibizumab~     intravitreal administration in neovascular AMD patients has been shown to effectively reduce~     vascular leakage and growth of CNV and to stabilize or improve visual function.~      To further improve visual acuity, a combination therapy using efalizumab and ranibizumab is~     proposed. Efalizumab could target the adhesion factors that precede angiogenesis and improve~     the outcome for AMD patients in combination with the anti-VEGF agent, Ranibizumab.~   "
216437|NCT00726453|"~     The objective of the study is to assess the safety and effectiveness of the Resolute~     Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native~     coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.~   "
216438|NCT00726440|"~     The Capteur Evadiac study group, composed of French and Belgian diabetologists, has~     designed a 1 year randomized controlled multicenter study in order to define what should be~     the best clinical way of using continuous glucose monitoring in the long term to improve~     metabolic control in uncontrolled type 1 diabetes patients.~   "
216439|NCT00726427|"~     The purpose of this study is to assess safety and tolerability of AZD1656 after single~     ascending oral doses in healthy male subjects~   "
216440|NCT00726414|"~     The purpose of this study is to evaluate and compare the relative bioavailability of Quinine~     Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed~     conditions.~   "
216441|NCT00726401|"~     You are being asked to take part in a research study of COLD-fX, a product designed to boost~     the immune system. COLD-fX is an extract from the roots of North American ginseng and it may~     offer some benefit to people with seasonal allergies.~      The purpose of the present study is to find out how effective and safe COLD-fX is in~     improving quality of life and reducing symptoms of seasonal allergies such as hay fever.~     COLD-fX is not yet approved for treatment of seasonal allergies. We are seeking to enroll 200~     participants in the Capital Health region.~   "
216442|NCT00726388|"~     This is an open-label, multiple-dose, safety study of DIC075V in patients with acute~     post-operative pain following abdominal or orthopedic surgery.~   "
216443|NCT00726375|"~     This is a clinical trial to see if treatment with etanercept for early skin graft-versus-host~     disease (GVHD) can effectively treat and prevent progression of the disease without using~     high dose steroids.~      GVHD is a common complication following a bone marrow transplant from another donor. GVHD~     occurs after transplant, when the donor's blood cells (called lymphocytes) recognize parts of~     your body, such as the skin, as foreign. A certain chemical, called Tumor Necrosis Factor, or~     TNF, also causes damage to the skin. The main effect on the skin is a red rash, when the skin~     GVHD is mild, but in more severe forms the skin can blister.~      We have been studying GVHD at the University of Michigan for the past decade. We know that~     high levels of TNF makes GVHD worse. Our research has shown that adding an anti-TNF drug~     (called etanercept or Enbrel®) to the standard GVHD treatment of high dose steroids leads to~     improvement in the GVHD in twice as many patients compared to when steroids alone are used.~     It is now standard practice at the University of Michigan and many other centers to treat~     GVHD with both steroids and etanercept.~      The management of early skin GVHD for most patients involves treatment with steroids, given~     both as a cream and by either the mouth (in pills) or IV. Early skin GVHD is also called~     grade I GVHD, which means the skin rash covers less than half of the body. Steroid treatment~     can be effective; however, it also causes many complications such as an increased risk of~     infection, weight gain, stomach ulcers, muscle weakness and bone damage, among many others.~     We have developed this study to test whether starting treatment with etanercept and steroid~     creams alone can treat the GVHD without requiring the use of high dose steroids. The goal is~     to avoid the complications that come with high dose oral or IV steroid treatment. The high~     dose steroid treatment would only begin if your GVHD got worse.~   "
216444|NCT00726362|"~     The primary objective is to survey the efficacy of various commercially available statins (a~     class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin,~     lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients~     with hyperlipidemia. Surveillance data (Lipid Profile) will be collected during course of~     usual clinical practice or captured upon its availability.~   "
216445|NCT00726349|"~     The objective of our research program is to determine the transfusion threshold required to~     maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in~     these, most often, elderly patient with serious comorbidities.~      Hypothesis: we hypothesize that a threshold hemoglobin concentration exists below which~     functional recovery becomes difficult, even if the vital prognosis of patients is not~     impaired.~   "
216446|NCT00726336|"~     A study in healthy volunteers to determine whether there is a drug interaction between~     GSK1349572 and tenofovir~   "
216447|NCT00726323|"~     This clinical study is being conducted at multiple sites to determine the best confirmed~     response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell~     carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic~     forms; subjects with either classification will be accepted into this study.~   "
216448|NCT00726310|"~     The purpose of this open, multi-center study is to prospectively collect outcome data on~     patients who are having lumbar spinal fusion surgery with implantation of the SpineLink®~     system.~   "
216449|NCT00726284|"~     The purpose of this patient registry is to prospectively collect data on patients who are~     having spinal surgery with EBI and Interpore Cross Spine Products.~   "
216507|NCT00725478|"~     The aim of the non-interventional Post Marketing Study is to investigate the use of the~     non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy~     in patients with Morbus Parkinson. Tolerability and course of the disease or change of~     parkinsonian symptoms during stabilisation on, or change over from other dopamine agonists~     will be documented under routine conditions. Piribedil should be prescribed according to its~     marketing authorisation by the responsible neurologist.~   "
216450|NCT00726271|"~     An innovative dietary approach to obesity, based on the set-point theory of body weight and~     associative learning, was developed by Seth Roberts. Roberts's approach focuses on~     dissociating flavor and calories by consuming small amounts of very bland but calorie-dense~     foods such as extra-light olive oil between meals. Roberts believes that the dissociation~     between flavor and calories lowers the body weight's set point, suppressing appetite and~     thereby inducing weight loss without causing hunger. Studying the feasibility of this~     approach is particularly relevant to patients taking drugs that cause increased appetite and~     weight gain as a side effect, as increased hunger makes the usual calorie restriction~     approach even more difficult than it normally is. Low-income people have a diet higher in~     prepackaged standardized foods, which may be one contributing factor to their higher risk of~     developing obesity.~      Specific Aims~        -  To test the acceptance of, and the patients' compliance rate to, the Shangri-La Diet~        -  To ascertain whether a controlled clinical trial of the Shangri-La Diet would be~          feasible.~        -  To see if the weight loss documented anecdotally in many people is reproducible in~          patients from low-income areas who are overweight and taking prescribed medications~          associated with increased appetite and weight gain.~      Analysis: The primary end point will be acceptability of the dietary intervention as measured~     by the final interview and the evaluation form—is this something patients would be willing to~     do over the long term? This will help determine whether a controlled trial of the dietary~     intervention would be feasible, and provide information needed to design such a trial.~     Secondary outcomes will be changes in the participants' weight, waist measurements, anxiety,~     and depression scores~   "
216451|NCT00726258|"~     Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in~     preventing acute postoperative pain. A previous study performed in the service testing the~     association ketamine/morphine versus morphine PCA, postoperative, for patients who do not~     benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of~     postoperative pain associated with a reduction of nocturnal arterial desaturation following~     surgery when ketamine was added to morphine.~   "
216452|NCT00726245|"~     the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF~   "
216453|NCT00726232|"~     To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib~     (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and~     those with essential thrombocythemia (ET). Patients in each group will be refractory to~     hydroxyurea or for whom hydroxyurea is contraindicated.~   "
216454|NCT00726219|"~     This study is designed to compare femoral perineural catheter insertion distances, in order~     to help determine which is the best for pain relief after knee surgery.~      Hypothesis: the quality of the femoral nerve block will not be inferior if the catheter is~     inserted deeper (7cm compared to 3 cm)~   "
216455|NCT00726206|"~     The general movement and the electroencephalogram analysis of the preterm have a high~     predictive value of the neuro-developmental outcome of the infants.~   "
216456|NCT00726193|"~     The purpose of this clinical outcomes collection study is to analyze the effect of the EBI~     OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no~     visible progressive signs of healing) fracture in a prospective database.~   "
216457|NCT00726180|"~     The majority pf breast cancers present as ER-positive, many of which are able to be targeted~     with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has~     the potential to benefit patients by making hormonal therapies a therapeutic option and~     possibly improving their overall prognosis.~   "
216458|NCT00726167|"~     The purpose of this study is to test a new method for diagnosing and monitoring~     Ventilator-Associated Pneumonia, which is a major killer among ICU patients. The method~     requires analysis of a small amount of the patient's blood for concentration of a hormone~     called Procalcitonin.~   "
216459|NCT00726154|"~     The objective of this pilot study is to test the feasibility of a larger planned trial. The~     objective of this larger trial will be to determine the extent to which aspects of circadian~     rhythmicity, including, sleep/wake rhythms, daily social routines (i.e., social rhythms),~     circadian type (morningness/eveningness), endogenous circadian rhythms and polymorphisms~     associated with altered circadian function in specific genes (namely, CLOCK, Period 2 and~     Period 3) moderate treatment response in bipolar disorder.~   "
216460|NCT00726141|"~     Despite rising smoker rates, particularly in girls and young women, only few studies have~     focused on smoking cessation in young smokers. Gynaecologist practices may be an ideal~     setting to proactively intervene with young female smokers. Elevated health risks of smoking~     while using hormonal contraceptives could be a successful approach to gain young women's~     attention on smoking cessation. The purpose of this study is to evaluate the effectiveness of~     a smoking cessation intervention for girls and young women visiting gynaecologist practices~     and using hormonal contraceptives.~   "
216461|NCT00726128|"~     To prospectively collect radiographic and outcome data on patients who are having cervical~     spine fusion surgery with the VueLock™ Anterior Cervical Plate System~   "
216462|NCT00726115|"~     The main objectives of this study is to assess the safety and tolerability of ascending~     single and multiple oral doses of SAM-531 in healthy subjects~   "
216463|NCT00726102|"~     Inadequate feeding of infants and toddlers impairs physical and cognitive development and is~     a major contributor to early childhood infectious disease illnesses and preventable~     mortality. Optimal feeding has two broad components: Exclusive breast feeding (EBF) for the~     first-6 months followed by continued breast feeding accompanied by complementary foods (CF)~     that is adequate in quantity and quality. While EBF is theoretically straightforward, CF is~     more complex. This is because CF is typically limited mainly or entirely to plant-based foods~     in developing countries worldwide. Dependence on adequate, affordable locally-produced foods~     for complete CF requires an inexpensive, regular source of meat especially to provide~     'problem' micronutrients, notably, but not only, zinc and bioavailable iron. While the use of~     micronutrient-fortified CF and of supplements, including SprinklesTM, is spreading, their~     efficacy largely remains uncertain as does their availability, particularly on a sustainable,~     affordable basis Achievement of the widespread regular use of meat as a CF requires: (1)~     adequate local production of affordable small scavenging/foraging animals in poor rural and,~     where feasible, periurban communities worldwide; (2) effective communication for behavioral~     change/education so that young children, starting at age 6 months (when meat is readily~     accepted by infants), receive priority in the use of this meat. Solid scientific evidence of~     the value of international/national programs to achieve this goal is essential to provide the~     basis and incentive for major international and national programs to promote the feeding of~     meat as an early and regular CF. The acquisition of such evidence is the goal of this study~      The intervention to be evaluated is meat fed daily as a complementary food from age 6-18~     months. Thirty infants-toddlers in each of 60 rural communities (total of 1,800 subjects)~     will participate. In a cluster design, twenty communities (test) will be randomized to~     receive meat,twenty communities (control) will receive a plant recipe providing the same~     amount of calories, twenty communities (fortified cereal) will receive a commercially~     available fortified cereal providing the same amount of calories. This project will be~     located in rural China in a county where high quality collaboration is already established,~     and where we have recently demonstrated inadequate bioavailable zinc intake and zinc~     deficiency in toddlers. We have also found a high (30%) incidence of stunting, now widely~     used as an indirect indicator of populations with zinc deficiency. Other advantages of this~     location include the willingness of doctors located in each rural community to provide the~     test or control meal 7 days per week in their homes and the absence of any access to~     supplements / fortified products which could complicate interpretation of data. The young~     children in the test communities will receive certified safe lean pork 7 days per wk.~     Starting with a very small quantity at 6 months, the quantity of lean pork will be increased~     as infants are ready to take more up to a plateau of 2 oz/d. No subsequent increases are~     planned because neither zinc nor iron requirements increase from 6-11 months to 12-18 months.~     Lean pork will be used because pigs are ubiquitous in China and can be maintained cheaply by~     scavenging/foraging on waste materials adjacent to human habitation. Test and control~     clusters will also receive nutrition education to achieve maximal diversification of locally~     available affordable foods. Longitudinal outcome measures include indices of physical growth,~     especially length; infectious disease incidence and prevalence; cognitive development; zinc~     and iron intake and biomarkers for these and other micronutrients. Zinc absorption will be~     measured. Data will flow daily from communities to the district hospital in Xi-Chou, weekly~     to the data manager in Shanghai and 3-monthly to the Data Monitoring Safety Board (DSMB) and~     to the University of Colorado research group.~   "
216464|NCT00726076|"~     The purpose of this study is to test a computer program for people with epilepsy. The program~     was developed to help people with epilepsy improve their self-management skills for taking~     medications, reducing stress, and sleeping well.~   "
216465|NCT00726063|"~     This study will evaluate the contributions of the Nanotite implant design when used by~     graduate students in their first year of placing implants.~   "
216466|NCT00726050|"~     This study will use repetitive transcranial magnetic stimulation, or rTMS (magnetic~     stimulation to the brain), to examine how the brain distinguishes between two signals that~     are spaced very closely in time. The ability to tell the difference between sensory signals~     is important to understanding sensory input. Understanding how this works may help to develop~     new treatments for sensory deficits.~      Healthy volunteers 18 years of age and older may be eligible for this study. Participants~     undergo the following procedures during three visits to the NIH Clinical Center:~      rTMS - all visits (sham rTMS on one visit) :~      For TMS, a wire coil is held on the scalp. A brief electrical current passed through the coil~     creates a magnetic pulse that stimulates the brain. During the stimulation, the subject may~     be asked to tense certain muscles slightly or perform other simple actions.~      Theta burst stimulation (TBS) - all visits (sham TBS on one visit):~      Same as TMS, but brief pulses of electrical current are passed through the coil. Subjects~     undergo intermittent TBS on one visit and continuous TBS on another.~      Somatosensory evoked potential (SEP) - all visits:~      SEP tests how sensory information travels along the nerves to the spinal cord and brain. A~     small metal disk electrode placed on an arm delivers a small electrical shock. Electrodes~     placed on the scalp record how the impulse travels over the nerve pathways to the cerebral~     cortex of the brain. EEG (see below) records what sensory information the brain is detecting~     and processing. Paired-pulse SEP is done before and after TBS.~      Temporal discrimination threshold - all visits:~      This test investigates the brain's ability to discriminate sensory information. Electrodes~     are placed on the subject's wrist. Two electrical pulses are delivered to the nerve at the~     wrist at different spaced intervals to determine when the subject feels the two pulses are~     fused into one. This test is done before and after TBS.~      Electroencephalography (EEG) - all visits:~      This test records brain waves (electrical activity of the brain). Electrodes are placed on~     the scalp with an electrode cap. The spaces between the electrodes and the scalp are filled~     with a gel that conducts electrical activity.~   "
216468|NCT00726011|"~     Different pathophysiologic mechanisms are responsible for the development of chronic pain~     disorders. Pain pathways are triggered in part by ectopic discharges of voltage-sensitive~     sodium channels, which are in abundance in both the peripheral and the central nervous~     systems. Tetrodotoxin (TTX) is a selective blocker of Na+ channels and causes analgesia~     either by decreasing the propagation of action potentials by Na+ channels and/or by blocking~     of ectopic discharges associated with chronic pain. TTX is extracted from the puffer fish~     (fugu). Results from animal pharmacology studies revealed that TTX is a more potent analgesic~     than standard analgesic agents such as aspirin, morphine or meperidine.~      At present, the management of severe cancer pain generally includes the use of opiates. This~     can often result in undesirable side effects, and treatment with this type of medication is~     not always effective. Because currently available pain-relieving therapy is unsatisfactory~     for many patients, there is a need for new therapeutic approaches for the management of~     moderate or severe cancer pain.~      Recent studies indicate that intramuscular (into a muscle) or subcutaneous (under the skin)~     injections of tetrodotoxin (TTX) may reduce pain in cancer patients who did not respond to~     standard therapies.~      The current proposed study (TEC-006OL) is designed to provide the option for all patients who~     participated in the TEC-006 study (both tetrodotoxin and placebo-treated) to receive or~     continue to receive tetrodotoxin treatment.~   "
216469|NCT00725998|"~     Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked~     compound action potential (ECAP) of the auditory nerve represents an option to assess changes~     in auditory nerve responses and the interaction between the electrode and the neural tissue~     over time.~      Aim: To study ECAP in children during the first year of CI use.~      Material and methods: The ECAP characteristics have been analyzed in 13 children implanted~     younger than three years old. SERIES STUDY.~      Descriptors:~      Cochlear Implantation,cochlear nerve,child.~   "
216470|NCT00725985|"~     A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of~     oral cladribine versus placebo in subjects who had a first clinical demyelinating event~     (clinically isolated syndrome). Subjects in either the cladribine or placebo group may also~     enter treatment periods with open-label interferon-beta or open-label cladribine depending~     upon the disease status. The primary objective of this study is to evaluate the effect of two~     dosage regimens of oral cladribine versus placebo on the time to conversion to multiple~     sclerosis (MS) (from randomization) according to the Poser criteria in subjects with first~     clinical demyelinating event at high risk of converting to MS.~   "
216471|NCT00725972|"~     Several recent clinical trials have documented that early aggressive resuscitation approached~     guided by defined hemodynamic variables using thoughtful protocols may improve outcome. The~     concept underscored by this newer trial was that appropriate resuscitation prevents~     subsequent tissue injury even if overt shock is present, if the resuscitation is carried out~     early enough.~   "
216472|NCT00725959|"~     In this randomized controlled trial, we will identify social networks on Facebook, an~     randomly assign each network to control or intervention status. We will then intervene at the~     level of the network with dynamic, interactive HIV prevention messages (intervention) or~     static messages about HIV prevention (control). We will develop the intervention content with~     input from our target audience (Facebook users) and will measure baseline, and 3 and 6 month~     assessments of condom use and abstinence among all participants~   "
216473|NCT00725946|"~     This is a pilot imaging study for women whose tumors express NIS [Na+I- symporter, sodium~     iodide symporter]. Eligibility is limited to the presence of strong (3+) and/or plasma~     membrane staining in > 20% of cells as determined by immunohistochemical methods. A total of~     10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine~     radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will~     be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and~     methimazole (impedes organification). Tumor, organ and whole body dosimetry will be~     calculated in each patient.~   "
216474|NCT00725933|"~     Safety and Tolerability of BIIB028~   "
216475|NCT00725920|"~     The study is 12-week randomized placebo controlled trial compared to topiramate to treat~     patients with posttraumatic stress disorder, according to DSM-IV criteria.~      Patients will receive topiramate or placebo, the dose will start with 25 mg/day and every~     week 25mg will be increment according to patients tolerance to side effects.~      Patients will be evaluated by blind raters using Clinician-Administered PTSD Scale (CAPS),~     Beck Depression Inventory (BDI) , Beck Anxiety Inventory (BAI), 36-Item Short Form Health~     Survey (SF-36), Social Adjustment Scale (SAS).~      the outcomes will be improvement on Posttraumatic Stress Disorder (PTSD), Depression,~     Anxiety, quality of life and social adjustment scale according to scales above.~   "
216476|NCT00725907|"~     PRP will enhance ATFL tears healing by time and quality.~   "
216477|NCT00725894|"~     The purpose of this multi-center prospective clinical outcomes study is to determine validity~     and safety of the pediatric locking nail for femoral fracture management in children with~     open physes.~   "
216478|NCT00725881|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of multiple,~     once-daily, intravenous doses of trans sodium crocetinate (TSC). The effectiveness of TSC in~     alleviating the symptoms of intermittent claudication (IC) will also be assessed.~   "
216479|NCT00725868|"~     In stent restenosis and myocardial infarction are have been linked the balance between injury~     and healing of the endothelium These processes can be measured respectively using the number~     of circulating endothelial cells and endothelial progenitor cells. We therefore aimed to~     evaluate the relationship between the balance of injury and healing of the endothelium at the~     time of PCI and major adverse cardiovascular events including death, myocardial infarction~     and target lesion revascularization at 6 and 12 months follow-up.~   "
216480|NCT00725855|"~     The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50~     sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize~     the P50 ratio.~      Data produced in this study will provide useful information regarding the value of P50 as an~     efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional~     P50 studies.~   "
216545|NCT00724984|"~     The first part of the study will determine the highest dose of study drug that can be taken~     without causing serious side effects in patients with lymphoma. The appropriate dose~     determined from the first part of the study will be used in the second part of the study to~     assess disease response in 2 different types of lymphoma patients.~   "
216482|NCT00725829|"~     The aim of the current study is to evaluate whether treatment with high doses of simvastatin~     can reduce coagulation activation in patients with acute coronary syndromes and if ezetimibe~     in conjunction with simvastatin may affect blood clotting in a similar manner.~      The investigators hypotheses are as follows:~        1. Intensive lipid lowering treatment with simvastatin (40 mg/day) and simvastatin (40~          mg/day) combined with ezetimibe (10 mg/day) initiated after acute coronary syndrome~          leads to attenuation of blood coagulation including reduced thrombin generation,~          thrombin-mediated coagulant reactions, and improved structure of plasma clots.~        2. Anticoagulant effects of simvastatin are weaker than those observed during~          administration of simvastatin and ezetimibe.~   "
216483|NCT00725803|"~     The purpose of this study is to examine the safety, tolerability, pharmacokinetics (studies~     how the body processes a drug), and initial activity of GS-9450 in preventing liver damage~     due to scarring, or fibrosis, caused by Hepatitis C Virus (HCV) infection.~   "
216484|NCT00725790|"~     The purpose of this study is to determine if 12 weeks of flexible-dose vardenafil therapy~     demonstrates superior efficacy compared to placebo in subjects with ED solely secondary to a~     traumatic spinal cord injury~   "
216485|NCT00725777|"~     Patients with non-falciparum infection will be given artemether-lumefantrine for three days~     and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on~     immunology will be performed.~   "
216486|NCT00725764|"~     This study is being conducted to determine the best confirmed response rate, safety, and~     tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the~     head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor~     tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets~     of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg,~     MET, VEGFR2/kinase insert domain receptor [KDR]). Since MET overexpression has been~     associated with poorer prognosis and MET tyrosine kinase mutations have been reported in~     SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may~     be of therapeutic benefit in this patient population.~   "
216487|NCT00725751|"~     Although injection drug users represent the majority of new and existing cases of infection~     with hepatitis C virus (HCV), many lack access to treatment because of concerns about~     adherence, effectiveness, and reinfection. On the basis of a small but growing body of~     evidence showing that injection drug users can undergo treatment for HCV infection~     successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance~     users be treated for HCV infection on a case-by-case basis. In this study, all patients will~     receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European~     labeling; one cohort of participants will also be receiving substitution therapy (opioid~     medicines with long-lasting effects [methadone + buprenorphine] or morphine).~   "
216488|NCT00725738|"~     The purpose of this study is to evaluate the ejection fraction (EF) increase at 6 months~     follow up and major adverse cardiovascular events (MACE) after intracoronary autologous stem~     cell transplantation in ST elevation myocardial infarction patients versus a control group.~   "
216489|NCT00725725|"~     The purpose of this study is to evaluate the effectiveness of Org 25935 vs. placebo given in~     combination with cognitive-behavioral therapy (CBT) to reduce the symptoms of panic disorder.~     It is hypothesized that treatment with Org 25935 at a dose of 4 mg or 12 mg will differ~     significantly from placebo with respect to the Panic Disorder Severity Scale (PDSS) total~     score over 3 weeks of therapy.~   "
216490|NCT00725712|"~     This clinical study is being conducted at multiple sites to determine the best confirmed~     response rate, safety, and tolerability of GSK1363089 treatment in metastatic gastric~     carcinoma.~   "
216491|NCT00725686|"~     The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of~     neovascular/wet AMD~   "
216492|NCT00725673|"~     Patients with COPD have been found to have an increased risk of osteoporosis. The underlying~     mechanism is not clear yet. This case control study aims to identify risk factors for~     osteoporosis in GOLD II COPD patients. COPD GOLD II patients with osteoporosis (cases) will~     be matched by gender and age to COPD GOLD II patients without osteoporosis(controls).~      Possible risk factors for osteoporosis are:~        -  BMI/VVMI (body composition)~        -  emphysema vs chronic bronchitis~        -  physical capacity~        -  Use of certain medication (eg corticosteroids, SSRI's)~        -  Nutritional status~        -  Infectious parameters Outpatients from the pulmonary ward of the Catharina Hospital~          Eindhoven with GOLD II COPD according to the ATS and GOLD-guidelines will be included in~          the study (after written informed consent).~      A DEXA-scan will be made, if patients are osteoporotic or have a normal BMD they will be~     included in the study.~      A HRCT will be made, a six minutes walking distance will be performed, blood will be drawn~     for lab. analysis, an X-ray of the vertebral collum will be made, impedance will be measured~     and hight and weight will be measuered. Also patients will fill in a questionaire.~      By univariate and multivariate analysis the collected data will be analysed to determine~     possible risk factors for th development of osteoporosis in COPD GOLD II patients.~   "
216493|NCT00725660|"~     BACKGROUND: Pre-eclampsia complicates about 2% of pregnancies. It accounts for at least 50~     000 maternal deaths per year worldwide and is the second most common cause of maternal death~     in the developing world. Also, Pre-eclampsia is the commonest cause of iatrogenic~     prematurity, It frequently coexists with intrauterine growth restriction (IUGR) and placental~     abruption, other important causes of adverse prenatal outcome.~      There have been many studies investigating whether the disease can be prevented. In order to~     achieve this, one needs to be able to identify firstly those women that are at highest risk~     of the disease.~      Early studies showed that impedance to flow in the uterine arteries decreases with gestation~     in normal pregnancies, while in pregnancies with established pre-eclampsia or IUGR the~     impedance is increased.~      These observations led to a number of screening studies in the second trimester, which~     assessed if it is possible to predict those pregnancies destined to have complications of~     impaired placentation. These studies showed that women with increased impedance to uterine~     artery blood flow have an increased risk of developing pre-eclampsia, and detection can be~     further increased by using angiogenic factors (That are involved in the pathogenesis of Pre-~     eclampsia and could be useful for early prediction of the disease: VEGF, PIGF, PP13, sFLT1)~     in combination with uterine arteries Doppler study in the second trimester.~      METHODS: In this study we would like to add uterine arteries Doppler to the early routine~     detailed ultrasound examination (14-16 weeks), in 3000 women in Jerusalem. in addition we~     would like to check angiogenic factors from the serum blood taken for the routine triple test~     in these women (16-18 weeks).pregnancy outcome would be collected after labour from the~     medical centers participating in this research.~   "
216546|NCT00724971|"~     To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544)~     in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).~   "
216494|NCT00725647|"~     Premature babies are affected by a condition known as patent ductus arteriosus in which the~     ductus arteriosus (a normal structure) fails to close after birth as it should. A very large~     ductus can put extra strain on the heart and lungs, making the baby's breathing dependent on~     a mechanical ventilator. Attending physicians can close the duct with medical\or surgical~     treatment but assessing whether this is justified can be difficult. The physician usually~     bases this decision on assessment of the baby's general condition and an ultrasound~     evaluation of the heart (called an echocardiogram) but the last is particularly dependent~     on availability of skilled operators.~      The investigators have examined whether blood levels of a hormone called B-type natriuretic~     peptide (Nt pro-BNP)in the first week of life predict the need to treat a ductus arteriosus.~     This hormone is produced by the heart if it is under strain. If the test is helpful it could~     reduce dependence of physicians on echocardiography by skilled operators.~      Babies who were recruited had blood samples collected on days 1, 2, 3 and 7 for measurement~     of Nt pro-BNP. Each baby also had an echocardiogram performed between the fifth and seventh~     day of life. Decisions about treatment of the duct were made by attending physicians~     independent of the study. Physicians, investigators and echocardiographers were blinded to~     knowledge of the Nt pro-BNP concentration. Nt pro-BNP was also measured before and after~     treatment in all babies who had a PDA treated and echocardiography performed to confirm~     closure.~      Receiver operating characteristics (ROC) curves were used to assess the predictive value of~     Nt pro-BNP for samples collected at each time point. The investigators also compared the Nt~     pro-BNP levels in samples collected before and after treatment to assess the usefulness of Nt~     pr-BNP as an indicator of duct closure.~   "
216495|NCT00725634|"~     Phase 1 study to determine safety, tolerability, dose-limiting toxicities (DLTs), and~     recommended Phase 2 dose of AV-299 administered IV as monotherapy to patients with relapsed~     or refractory solid tumors, lymphoma, or multiple myeloma. The study will also determine the~     safety, tolerability and DLTs of AV-299 in combination with erlotinib in patients with~     relapsed or refractory solid tumors.~   "
216496|NCT00725621|"~     This is a prospective, open-label, 1-arm, multicenter observational study to determine the~     average Remicade dosage and time span between 9 infusions in subjects with rheumatoid~     arthritis (RA)~   "
216497|NCT00725608|"~     The purpose of this study is to evaluate the acceptability and safety of switching to~     Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication~     dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to~     study enrollment and who are willing to participate, will initiate therapy on Day 1 of the~     study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and~     determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be~     collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of~     Month 12.~   "
216498|NCT00725595|"~     The overall purpose of this study is to determine the effects of adaptive servo ventilation~     (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of~     breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the~     physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced~     exercise capacity and possibly ventricular arrhythmias. The intent of the proposed~     intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.~   "
216499|NCT00725582|"~     The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on~     airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given~     as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a~     screening period and a treatment period which includes doses on day 1 and day 8.~   "
216500|NCT00725569|"~     The planned study will be conducted in a prospective, randomized, double blind placebo~     controlled manner. Two anti-traumatic Homeopathic remedies (Arnica montana and~     Staphysagria) will be used. The selection of these remedies was based on a previous trial~     that showed a statistical difference in Hemoglobin levels favoring pregnant women treated~     with these drugs following delivery.~      The proposed study will focus on the post-operative recovery of women undergoing Cesarean~     section. According to Homeopathic principles, these two remedies are believed to improve the~     vital force, and will therefore improve convalescence following surgery in the study group.~     The study will include 90 women between the ages of 18 and 50 years who are scheduled for~     elective Cesarean Section. Exclusion criteria are: obesity (above 100kg), malignancy,~     psychiatric illness, diabetes and multipara pregnancies. Participants will be inducted~     following a detailed explanation by an MD and signing of an informed consent form, and then~     subdivided randomly into three groups numbering 30 in each: Two groups will be treated with~     homeopathic drugs of varied doses, and the third will get a placebo remedy which is~     indistinguishable from the other drugs. Outcome measures will include: 1. Blood loss - as~     estimated by a reduction in serum Hemoglobin levels. 2. Pain -to be evaluated by a numerical~     rating score (NRS) 3. Analgesic use 4. Length of post-operative stay and complications. 5.~     Quality of life outcomes - to be assessed using the MOS SF-36 questionnaire at one and four~     weeks following surgery. Although not expected, adverse events will be monitored.~      If, as we anticipate, the homeopathic treatment proves to be both safe and effective in~     shortening the duration of post-operative healing, this will have significant implications,~     with respect to both healthcare costs and patient suffering. It will also open the door for~     further research in the field of trauma medicine, as well as other stress-related illness.~   "
216501|NCT00725556|"~     The purpose of this study is to evaluate the process of development of autistic children, in~     a direct and indirect intervention context from mother´s response in Autism Behavior~     Checklist.~   "
216502|NCT00725543|"~     This is a prospective, open-label, 1-arm, multicenter observational study to determine the~     dose and time span of Remicade between infusions for ankylosing spondylitis (AS).~   "
216503|NCT00725530|"~     The purpose of this study was to measure lipid deposits on commercially marketed contact~     lenses when worn on an extended wear (overnight) basis for 7 days.~   "
216504|NCT00725517|"~     The purpose of this study is to evaluate the efficacy and safety of a 7.5% Icodextrin~     peritoneal dialysis solution for once-daily long dwell exchange in patients undergoing~     Continuous Ambulatory Peritoneal Dialysis (CAPD) in Chinese uremic patients.Patients were~     divided into Dianeal group or Extraneal group for long dwell time. Net ultrafiltration, small~     solute clearance and relationship between different transport group were used to evaluate~     efficacy of Icodextrin. Physical examination, vital signs and laboratory tests were used to~     evaluate safety of Icodextrin.~   "
216505|NCT00725504|"~     Our goals for this study involve using intravenous lidocaine as it is normally used in the~     Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic~     pain. Studies have been done determining the efficacy of intravenous lidocaine for treating~     pain but little research has been done to determine the effects of an intravenous lidocaine~     infusion on the different components of the pain experience. Our study will incorporate pain~     quality measures both before and during the infusions of lidocaine to determine changes in~     present pain intensity.~   "
216506|NCT00725491|"~     The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in~     Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant~     follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing~     COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).~   "
216508|NCT00725465|"~     The purpose of this study is to evaluate prospectively the usefulness of~     IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in our colon and rectal~     surgical practice, coincident with laparoscopic surgery, and assess whether it provides~     useful information that influences the type of surgical therapy intended. We also wish to~     further define the safety and extent of bowel distension when using IC-CO2. Furthermore, we~     wish to evaluate the therapy and technique of using this combined approach to the treatment~     of colorectal polyps and other localized, benign lesions of the large intestine. In this~     study, the colonoscope is used both as a diagnostic and therapeutic tool, and is often used~     in order to avoid a major bowel resection, yet effectively treat localized lesions of the~     large intestine.~      The hypothesis of this study is that IC-CO2 will provide useful information which does affect~     surgical decision making at the time of operation, and that it is safe and does not result in~     any significant bowel distention during or immediately after the procedure. We additionally~     hypothesize that certain localized lesions of the intestines may be treated using a combined~     laparoscopic-IC-CO2 approach to effectively treat the underlying disease, minimize risks to~     the patient, and avoid a major bowel resection.~   "
216509|NCT00725452|"~     Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and~     interval of Infliximab infusions for subjects with plaque psoriasis.~   "
216510|NCT00725439|"~     This study is looking at a new oral drug to treat acne. All patients in the study will get~     active drug, there is no placebo arm.~   "
216511|NCT00725426|"~     Study to examine whether rifampin has an effect on the pharmacokinetics of bosutinib.~   "
216512|NCT00725413|"~     The primary purpose of this study is to investigate the contraceptive efficacy, safety and~     acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in~     various countries in order to obtain country-specific data.~   "
216513|NCT00725400|"~     RATIONALE: Monoclonal antibodies, such as Cetuximab, can target tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.This is an~     anti-cancer drug which has already been approved by the FDA for use in patients who have~     Colorectal Cancer. Cetuximab can block tumor growth in different ways. Some block the ability~     of tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Radiation Therapy uses high-energy x-rays to kill tumor~     cells and cause less damage to normal tissue . Giving the drug Cetuximab together with~     Radiation Therapy may kill more tumor cells. Surgery is the most common treatment for~     Colorectal Cancer to remove the tumor, as well as a small margin of surrounding normal tissue~     and possibly nearby lymph nodes. Surgery is usually used in conjunction with other~     conventional treatments such as Radiation Therapy. Radiation Therapy before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation~     Therapy after surgery may kill any tumor cells that remain after surgery.~      Screening test such as Fecal Occult Blood Test (FOBT) and Colonoscopy has to be done. Tumor~     markers for Colorectal Carcinoma are Carcinoembryonic antigen (CAE) and CA 19-9 and to assess~     the response of tumor markers Carcinoembryonic antigen (CAE) and CA 19-9 will be used and~     periodically Colonoscopy has to be done. Colorectal Cancer Surgery are Colon resection~     (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation.~      PURPOSE: Determine the tumor response rate treated with Cetuximab and Radiation Therapy Vs~     Surgery before or after Radiation Therapy in patients with Colorectal Cancer from stage II to~     IV~   "
216514|NCT00725387|"~     Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool~     for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used~     in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT~     scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer~     detection was not attempted to date. We hope to learn what is the best approach for detection~     of cancer and thus to improve cancer treatment.~   "
216515|NCT00725374|"~     The primary purpose of this study is to compare changes in the expression of the~     proliferation marker Ki-67 in malignant breast tissue after treatment with tibolone or~     placebo in postmenopausal women who need to undergo surgery for primary breast cancer~   "
216516|NCT00725361|"~     This is a research study of an investigational drug called ambrisentan (Letairis) in the~     treatment and prevention of digital ulcers in patients with systemic sclerosis.~   "
216517|NCT00725348|"~     This is a study of a new oral drug used for the treatment of psoriasis. All subjects will get~     active medication, there is no placebo arm.~   "
216518|NCT00725335|"~     This is a multi-centre prospective randomized controlled trial to explore the influence of~     ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the~     prognosis of Hepatocellular Carcinoma (HCC) patients.~   "
216519|NCT00725322|"~     Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has~     also been reported to be helpful for some pain conditions. The investigators have observed~     prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin~     Type A (BTA) in patients with certain types of neuropathic pain. The investigators propose to~     study if addition of BTA extends pain relief compared to placebo when injected subcutaneously~     into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is~     perceived as painful).~   "
216520|NCT00725309|"~     Chronic obstructive pulmonary disease (COPD) is a lung disease that is primarily caused by~     cigarette smoking. The breakdown of elastin, a protein found in the lungs, can cause lung~     damage and may contribute to the development of COPD. Some people may be more prone to~     elastin damage and in turn to developing COPD than others. This study will examine whether~     genetic factors are responsible for altering elastin function and increasing the risk of~     developing COPD.~   "
216521|NCT00725296|"~     This is a prospective, open-label, 1-arm, multicenter observational study to determine the~     dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).~   "
216522|NCT00725283|"~     This study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer~     Immunotherapeutic (WT1 ASCI) as post-consolidation therapy in adult patients with~     WT1-positive Acute Myeloid Leukemia in first complete remission. It will also be analyzed to~     what extent this treatment induces an immune response, specific to the malignancy.~   "
216523|NCT00725270|"~     This study tests the hypothesis that mifepristone will diminish cognitive distortion and~     alleviate psychosis in patients with schizoaffective disorder.~   "
216524|NCT00725257|"~     The major environmental factors that increase the risk of type 2 diabetes, presumably in the~     setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent~     overweight and obesity. The high rate of weight regain has limited the role of lifestyle~     interventions as an effective means of controlling glycemia long term. The aims of the~     present study were: 1) To compare the effectiveness and safety of two nutritional protocols -~     namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive~     overweight patients with type 2 diabetes mellitus. The primary aim of the study was the~     effect on hemoglobin A1c levels; secondary aims were time to introduction of the first~     hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA~     goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with~     HbA1c < 7%.~   "
216525|NCT00725244|"~     Aim:~      To compare the efficacy, safety and number of sessions of bipolar eletrocoagulation (BEC) and~     argon plasma coagulation (APC) in the management of the bleeding telangiectasias from chronic~     radiation coloproctopathy (CRCP).~      Methods:~      Thirty patients with active bleeding from telangiectasias were enrolled in two groups (15 BEC~     and 15 APC) and classified according of Saunders score. BEC settings were 50 W and APC~     settings were 40 W and 1.0 l/min. Colonoscopy was the first exam to rule out synchronous~     lesions and follow-up was performed with sigmoidoscopies. Clinical cure was defined as~     cessation of bleeding and endoscopic cure was determined by absence of telangiectasias.~     Failure was defined whenever more than 7 sessions or other therapy was necessary.~   "
216526|NCT00725231|"~     Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is~     significantly worse than that of aggressive B cell lymphomas. The prospects of elderly~     patients are especially poor, with an estimated disease free survival of only 25% after three~     years. Previous phase II trials have demonstrated a significant activity of the monoclonal~     anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators~     thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense~     CHOP-14 in patients with previously untreated peripheral T cell lymphoma.~   "
216527|NCT00725218|"~     Uterine contraction pain is a common problem after abortion. Optimal analgesic for such~     suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable~     non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of~     prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress~     the uterine contraction pain after abortion effectively.~   "
216528|NCT00725205|"~     Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol~     (Ribavirin) combination therapy as their usual medical treatment. The current study aims to~     evaluate whether the previously introduced, and now widely accepted and implemented~     educational program, which represents additional efforts in everyday practice to increase~     patient compliance, will succeed in achieving adherence rate in treated participants similar~     to the extent demonstrated by clinical trials.~   "
216529|NCT00725192|"~     Sleep impairment is the most often reported of the 17 PTSD symptoms and is considered one of~     the most refractory to treatment. This study proposes the use of sleep-directed hypnotherapy~     to address sleep issues as a complementary element to empirically supported Cognitive~     Processing Therapy (CPT) in treating PTSD in sexual and physical assault survivors.~     Specifically the study aims to: 1) compare the results of sleep-directed hypnosis plus CPT~     with CPT only, 2) to assess the relationship between sleep and PTSD symptoms, 3) to examine~     relationships between sleep improvement, PTSD symptom improvement, and the therapeutic~     elements (hypnosis, exposure, cognitive therapy) to determine mechanisms of action in the~     intervention, 4) to assess the relationship between sleep and physical reactivity to~     trauma-related cues and to other stimuli.~   "
216530|NCT00725179|"~     Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to~     assess length of oral vs IV treatment and overall healthcare costs.~   "
216531|NCT00725166|"~     To reach the goals of living longer in better medical conditions, many countries reach the~     same conclusion: new strategies have to be developed to avoid, or at least limit, the effects~     of age; this requires a better knowledge of the mechanisms of aging. Our project focuses on~     the loss of muscle mass associated with aging, called sarcopenia. Sarcopenia unavoidably~     leads to impaired mobility and poor balance, which contributes to loss of functional autonomy~     and to increased prevalence for severe falls. Skeletal muscle also plays a central role as a~     reserve for energy and amino acids. Hence, sarcopenia further triggers severe side metabolic~     effects such as frailty among elderly persons. The precise mechanisms of muscle aging are~     still mostly unknown, although many theories have been proposed.~      The present study aims at better understanding the mechanisms of skeletal muscle loss~     associated with aging. Using muscle biopsies from young and old subjects, the differential~     expression profiles of mRNA will be obtained through chips that will evaluate more than 39000~     transcripts. On the same samples, proteomic analyses will involve two complementary~     approaches: (1) bidimensional electrophoresis (2DGE) coupled to mass spectrometry (MALDI-ToF)~     for dominant proteins; (2) Western-blot (more than 800 antibodies) targeting regulating~     proteins not detectable using 2DGE. Complementary histological studies~     (immunohisto-fluorescence, confocal microscopy) will specify the localisation of the major~     biomarkers in the muscle biopsies.~      The results of that research will have applications in the medium term and will lead to~     nutritional interventions to modulate specific metabolic pathways and improve the quality of~     life in the elderly.~   "
216532|NCT00725153|"~     The purpose of this study was to measure front surface deposits on contact lenses when worn~     for ten hours.~   "
216533|NCT00725140|"~     This is a observational, open, prospective, single arm cohort study within authorized SPC~     conditions to describe the effectiveness of Almotriptan in treating acute migraine attacks~     when pain is mild and in the first hour of pain in everyday primary care clinical practice.~   "
216547|NCT00724958|"~     The current observational program was determined to collect data on the real life dosing~     regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital~     setting.~   "
216548|NCT00724945|"~     The purpose of the study is to compare the visual performance of two soft bifocal contact~     lenses.~   "
216960|NCT00719433|"~     The goal of this study is to determine whether task-oriented, robot-aided therapy is more~     effective than conventional physical and occupational therapy at promoting functional~     recovery of the affected arm in chronic hemiparetic stroke patients.~   "
216534|NCT00725127|"~     Brief summary:~      Aspirin (ASA) has been shown to provide marked benefits in primary and secondary prevention~     of cardiovascular events. Substantial evidence suggests that low-dose ASA therapy should also~     be used as a primary prevention strategy in men and women with diabetes who are at high~     cardiovascular risk. On the other hand, there is current evidence on the potential benefits~     of low-dose ASA therapy in subjects with impaired fasting glucose, including those with~     metabolic syndrome. Most important, previous laboratory animal and clinical trial research~     convincingly demonstrates administration time-dependent (with reference to circadian rhythms)~     effects of ASA. Thus, the effects of ASA upon lipoperoxides, b-adrenergic receptors, and~     blood pressure (BP) in clinically healthy subjects depend on the circadian timing of ASA~     administration. The administration-time-dependent influence of ASA on BP was previously~     demonstrated in a randomized trial on healthy women and other independent double-blind,~     randomized, placebo-controlled clinical trials conducted, first, on clinically healthy~     subjects, a second one on normotensive and hypertensive subjects, a third one on pregnant~     women at high risk for preeclampsia and a fourth one in previously untreated patients with~     mild hypertension. The findings of these BP studies are consistent; BP-lowering effect of~     low-dose ASA is achieved when administered at bedtime but not upon awakening.~      In keeping with the chronopharmacological effects of ASA and the previous findings suggesting~     that ASA at low dose may exert a potential beneficial effect on BP, endothelium function and~     cardiovascular function, this prospective, randomized, parallel-arm study will investigate~     the potential influence of ASA on the primary prevention of cardiovascular, cerebrovascular~     and renal events in subjects with either impaired fasting glucose (≥ 100 mg/dl) or previous~     diagnosis of type 2 diabetes mellitus, who will receive low-dose ASA (100 mg/day) at~     different circadian times (upon awakening or at bedtime) in relation to their rest-activity~     cycle.~   "
216535|NCT00725114|"~     Different pathophysiologic mechanisms are responsible for the development of chronic pain~     disorders. Pain pathways are triggered in part by ectopic discharges of voltage-sensitive~     sodium channels, which are in abundance in both the peripheral and the central nervous~     systems. Tetrodotoxin (TTX) is a selective blocker of Na+ channels and causes analgesia~     either by decreasing the propagation of action potentials by Na+ channels and/or by blocking~     of ectopic discharges associated with chronic pain. TTX is extracted from the puffer fish~     (fugu). Results from animal pharmacology studies revealed that TTX is a more potent analgesic~     than standard analgesic agents such as aspirin, morphine or meperidine.~      At present, the management of severe cancer pain generally includes the use of opiates. This~     can often result in undesirable side effects, and treatment with this type of medication is~     not always effective. Because currently available pain-relieving therapy is unsatisfactory~     for many patients, there is a need for new therapeutic approaches for the management of~     moderate or severe cancer pain.~      Recent studies indicate that intramuscular (into a muscle) or subcutaneous (under the skin)~     injections of tetrodotoxin (TTX) may reduce pain in cancer patients who did not respond to~     standard therapies.~      The current proposed study (TEC-006) is designed to 1) demonstrate in a double-blind,~     placebo-controlled trial that the subcutaneous 30 μg b.i.d. dose of TTX for 4 days is~     effective in reducing pain outcome and improving quality of life; 2) characterize the onset~     and duration of analgesia, and 3) demonstrate that TTX is well tolerated in patients with~     inadequately controlled cancer-related pain.~   "
216536|NCT00725101|"~     The Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments~     (REFLECTIONS) Study is a 12-month, prospective observational study that will be utilized in~     approximately 58 care settings in the United States (US) and Puerto Rico. It is designed to~     examine treatment patterns and health outcomes of adult participants diagnosed by their~     physician with fibromyalgia (FM) and who are starting any new pharmacologic agent for FM.~      The primary benefit of this study is enhanced understanding of the disease state of FM and~     the role that pharmacologic treatment plays, which may help to optimize management of FM.~     This study will address current gaps in a rapidly growing body of literature on FM.~   "
216537|NCT00725088|"~     The purpose of this study is to determine whether exercise rehabilitation can reduce~     mortality, reinfarction or heart failure of patients after acute myocardial infarction.~   "
216538|NCT00725075|"~     The purpose of this study is to determine whether MK-8435 (Org 25935) is more effective than~     placebo in improving negative symptoms in participants with schizophrenia who are~     concurrently treated with a stable dose of a second generation antipsychotic.~   "
216539|NCT00725062|"~     RATIONALE: A donor peripheral stem cell transplant helps stop the growth of cancer cells.~     When the healthy stem cells from a donor are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Once the donated stem cells begin working, the patient's immune system may see the remaining~     cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of~     donor T cells may helps stop the patient's immune system from rejecting the donor's stem~     cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of donor T cells in~     treating patients with high-risk hematologic cancer who are undergoing donor peripheral blood~     stem cell transplant.~      Note: Only Phase I portion of study was performed. Due to slow accrual, study was closed~     before Phase II portion of study.~   "
216540|NCT00725049|"~     This prospective randomized study will evaluate the integration success while supporting a~     prosthesis for short implants placed into maxillary sites having minimal bone height that~     would otherwise need sinus augmentation. The resources utilized during treatment will be~     assessed.~      Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus~     augmentation procedures will offset differences in the cumulative implant survival rates~     observed between treatment groups.~   "
216541|NCT00725036|"~     This trial is conducted in Oceania.~      The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to~     s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.~   "
216542|NCT00725023|"~     Tennis elbow (Lateral epicondylitis) is a common condition seen in Family Medicine that gives~     rise to pain, and can lead to loss of function and time off work.~      The normal treatment for tennis elbow pain is oral pain relief medication (analgesia), and/or~     physiotherapy, local massage or even surgery. In mainland China, tennis elbow pain has also~     been treated using TDP © Heat-lamp therapy, and is considered to be an effective treatment~     for this condition.~      This study is a clinical trial that seeks to measure the effectiveness of the TDP © Heat-lamp~     therapy to relieve tennis elbow pain without the use of oral pain medication.~   "
216543|NCT00725010|"~     The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new~     concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a~     routine care setting.~   "
216544|NCT00724997|"~     The purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1~     administered as single dose intranasal aerosol for vaccination against influenza A (H1N1)~     virus.~      This study is performed further to assess local and systemic immune response and to analyse~     pharmacokinetics (shedding) of a single dose GHB01L1 aerosol administered intranasally.~   "
216549|NCT00724932|"~     The current trial was designed to demonstrate faster recovery from a neuromuscular blockade~     (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1~     sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in~     participants undergoing laparoscopic cholecystectomy or appendectomy under propofol~     anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit~     (PACU) length of stay.~   "
216550|NCT00724919|"~     To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, post-~     intervention in the selected medical centres~   "
216551|NCT00724906|"~     This will be two separate but identical studies: ALSE-A-02a, ALSE-A02b. Each study is~     designed to evaluate the diagnostic accuracy and safety of a single dose of 123I-ALTROPANE®~     in subjects with upper extremity tremor for less than three years. Currently, no~     radiopharmaceutical diagnostic imaging agent has been approved by the FDA in the U.S. for use~     in diagnosing Parkinson disease and related Parkinsonian syndromes. The diagnosis of~     Parkinsonian syndromes in the U.S. is based on clinical criteria only. The goal is to~     demonstrate that 123I-ALTROPANE® paired with SPECT imaging permits a more accurate early~     diagnosis of Parkinson disease than a clinical diagnosis by a general neurologist.~   "
216552|NCT00724893|"~     Treatment compliance is a key success factor in obtaining the full benefit of Pegetron~     (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients.~     Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen~     was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling.~     The study will assess the effect of the newly approved Pegetron Redipen on treatment~     compliance and its effect on sustained virologic response rates. Sustained virologic response~     is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months~     post-treatment.~   "
216553|NCT00724880|"~     -  Running title: Effect of Clopidogrel on Postoperative Bleeding in Patients undergoing~          Coronary Artery Bypass Surgery~        -  Title: Clopidogrel and bleeding in patients undergoing coronary artery bypass grafting.~          Is surgical delay necessary in patients using clopidogrel? And if so, which is the~          safety time interval when clopidogrel should be stopped before surgery in order to avoid~          bleeding and other related complications.~        -  Background: By blockade of the platelet ADP receptor, clopidogrel inhibits the binding~          of fibrinogen to the platelet GPIIb/IIIa receptor complex, thereby preventing platelet~          aggregation from ADP stimulation. Some authors suggest that the platelet function is~          completely recovered in 7 days after stopping clopidogrel in healthy subjects. Other~          researches suggest full recovery of platelet function in 3 to 5 days.~        -  Study objectives: To investigate if the interruption of the clopidogrel is necessary~          before CABG in order to prevent bleeding and other complications.~      To trace the increased risk patients for postoperative bleeding and to individualize the~     therapy according to TEG measurements.~        -  Design: A prospective, randomized mono- center study~        -  Patients: Patients who are receiving elective or urgent CABG surgery and are pre-treated~          at least 5 days before surgery with clopidogrel~        -  Primary endpoint: To determine if there are significant differences in blood loss,~          transfusions and rethoracotomies in the three selected groups of patients treated with~          clopidogrel To asses the predictive value of the TEG clot strength in postoperative~          bleeding in patients using Clopidogrel.~        -  Secondary endpoints: Death, myocardial infarction, stroke, respiratory failure, renal~          failure requiring dialysis, mediastinitis,readmission rates within 30 days from~          discharge, and ICU and hospital lengths of stay~        -  Risks: Using standard dose of aprotinin, we consider no increased risk in blood loss and~          other related complications for this three groups of patients.~        -  Possible benefits: Reduction of time delay in operating patients under treatment with~          clopidogrel.~      A more accurate time interval when clopidogrel should be stopped before surgery in order to~     eliminate the risk of bleeding and associated complications.~   "
216554|NCT00724867|"~     This is a continuation study to provide continuing treatment to subjects who completed study~     HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of~     belimumab(LymphoStat-B™) in subjects with SLE disease.~   "
216555|NCT00724854|"~     The objective of the study is to evaluate, in each group, the number of participants who~     achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol.~     The study will also assess whether RVR is a reliable predictor of sustained virologic~     response (defined as undetectable viral load at 24 weeks post-treatment).~   "
216556|NCT00724841|"~     Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of~     GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor~     activity against a variety of cell lines and models from different tumor origins.~   "
216557|NCT00724828|"~     Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy~     children and the carriage rate and distribution of Streptococcus pneumoniae serotypes~   "
216558|NCT00724815|"~     This study was a randomized, parallel group, double-blind, placebo controlled design to~     compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch.~     The primary objective of this study was to assess the proportion of subjects who were~     headache pain free at two hours after patch activation.~      Key secondary objectives included:~        1. The proportion of subjects who were nausea free at two hours after patch activation.~        2. The proportion of subjects who were photophobia free at two hours after patch~          activation.~        3. The proportion of subjects who were phonophobia free at two hours after patch~          activation.~   "
216559|NCT00724802|"~     Canavan disease is caused by Aspartoacylase deficiency. There is no treatment for the~     disease, but there is a food additive that includes acetate . We suggest an early treatment~     with acetate and a neurologic evaluation, including MRI, after 4 months of treatment. In any~     case the treatment will be stopped at the age of 22 months, when myelinization is ended.~   "
216560|NCT00724789|"~     The primary purpose of this study is to collect data on the incidence of congenital~     malformations in infants of women with an ongoing pregnancy after controlled ovarian~     stimulation with recombinant follicle stimulating hormone /ganirelix followed by in vitro~     fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this~     incidence with that of a group of women who used a long protocol with a gonadotropin~     releasing hormone agonist as historical controls.~   "
216561|NCT00724776|"~     This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of~     albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients~   "
216562|NCT00724763|"~     This research is designed to study the effects of needle acupuncture on blood pressure and~     HRV by stimulating certain acupuncture points and meridians.~   "
216576|NCT00724581|"~     Patients undergoing lung resection due to pulmonary cancer can be compromised in their~     postoperative period due to atrial fibrillation.~      A retrospective analysis performed at our institution indicates that 30 % of the population~     develope atrial fibrillation in the postoperative period.~      Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after~     heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population.~      Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after~     an initial loading bolus og 300 mg intravenously.~   "
216563|NCT00724750|"~     The current standard for negative pressure wound therapy is the Vacuum Assisted Closure~     Device (VAC), a commercial system that utilizes a computerized suction pump to apply negative~     pressure to an open-cell poly-urethane foam dressing sealed over a wound. The VAC system is~     effective but has some drawbacks:~        -  The system is expensive.~        -  There us conflicting data about the effectiveness of VAC therapy for infected wounds.~        -  VAC therapy is difficult to use (and frequently fails) in wounds with excess fluid~          drainage, and in wounds near body orifices.~      Over the past 4 years, we have accumulated additional experience with negative pressure wound~     therapy using wall suction applied to sealed gauze dressings with about 30 patients. We call~     this method G-SUC and have used it when we have been unable to maintain a dressing seal with~     the VAC system (due to excess drainage or wound location), for management if infected wounds.~     We have found this method to be effective without any specific negative side effects.~      Our specific aims are:~        1. Compare the effectiveness of G-SUC and standard VAC therapy. Outcomes measured for each~          method will include the proportional change in wound size over 1 - 2 weeks.~        2. Compare the effectiveness of G-SUC and VAC system in controlling wound infections as~          measured by the number of patients who are able to clear infection by 4 days.~        3. Compare the failure of each method of therapy by documenting the number of dressing that~          cannot be maintained because of fluid or suction.~        4. Measure and compare the cost of wound treatment with the two methods including direct~          cost and time spent at the bed side performing the dressing change.~      Our hypotheses are:~        1. G-SUC and VAC are equivalent for the treatment of uncomplicated wounds in the acute~          care, in-patient setting.~        2. G-SUC is more effective than VAC for management of infected wounds.~        3. G-SUC is more versatile than VAC, and functional G-SUC dressings can be maintained in~          situations where functional VAC dressings cannot.~        4. Negative pressure therapy with G-SUC is less costly than VAC.~   "
216564|NCT00724737|"~     The purpose of this study is to determine if functional MRI is precise enough to provide~     information about the location of brain functions in patients who have brain tumors. This~     might allow physicians to use a non-invasive procedure to assist with brain mapping prior to~     surgery~   "
216565|NCT00724724|"~     The purpose of the study is to evaluate the efficacy and safety of Butylphthalide Soft~     Capsules (En Bi Pu, NBP) in Secondary Prevention of Ischemic Stroke~   "
216566|NCT00724711|"~     This protocol describes a prospective, randomized, open-label, multicenter study to evaluate~     the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed~     dose emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in virologically suppressed,~     human immunodeficiency virus type 1 (HIV-1) infected subjects maintained on a~     ritonavir-boosted protease inhibitor (PI/r)-containing antiretroviral (ARV) regimen. Duration~     of treatment is 48 weeks.~   "
216567|NCT00724698|"~     Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will~     be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability~     and clinical efficacy will be measured.~   "
216568|NCT00724685|"~     Continuous bupivacaine administration through an elastomeric pump (Pain Buster) has been~     found effective for post operative analgesia in a large range of surgery. Ropivacaine is a~     less toxic drug, never tested in the surgery of latissimus dorsi and serratus micro~     anastomotic flaps (from the investigators knowledge). The aim of the study is to evaluate the~     usefulness of this drug and device for post operative analgesia, associated with patient~     controlled analgesia with morphine. For this purpose a controlled randomized double blind~     trial against placebo (saline) is performed, enrolling 40 (20x2) patients during 3 years, in~     order to measure total morphine consumption during the first 48 post operative hours and to~     evaluate analgesia and sides effects of morphine in each group.~   "
216569|NCT00724672|"~     This 14-week study will observe the gene expression of certain immune cells in patients with~     rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. Patients at the~     National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to~     receive an anti-TNF agent will be asked to participate in this study. Patients will receive~     their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples~     collected during the study and analyzed by the laboratory. Patient's response to their~     treatment will also be studied based on x-rays and other examinations.~   "
216570|NCT00724659|"~     The purpose of this study is to determine the usefulness of contrast in ultrasonography of~     the joints.~   "
216571|NCT00724646|"~     Hattie Larlham is a specialized long-term care facility for pediatric and young adult~     residents who are medically fragile and intellectually disabled, whose daily care is provided~     by direct care staff, Habilitation Assistants (HA), in conjunction with nurses and other~     direct care providers. The purpose of this study is to assess the perspectives of HA and~     parents/legal guardians on end-of-life care in a long-term care facility for pediatric and~     young adult residents who are medically fragile and intellectually disabled.~   "
216572|NCT00724633|"~     Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate~     sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and~     intradialytic symptoms will be assessed.~   "
216573|NCT00724620|"~     This study aims to evaluate the efficacy and safety of peginterferon alfa-2b plus~     weight-based ribavirin as initial treatment in chronic hepatitis C virus (HCV) genotype 1~     patients. All patients will receive peginterferon alfa-2b plus oral ribavirin for 12 weeks.~     At the end of this period, quantitative PCR will be used to determine the Early Viral~     Response (EVR) at this point of treatment. Total treatment duration will be 48 weeks for~     Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.~   "
216574|NCT00724607|"~     Active duty military personnel serving in the current and recent conflicts in Afghanistan and~     Iraq are frequently exposed to blasts and other mechanisms of traumatic brain injury~     (TBI).1,2 Although physical trauma is not unexpected during war fighting, survival after~     blast-related head injury has become a common occurrence only in recent years. As such, the~     associated cerebral damage is less well studied and understood.~      The Brain Injury Outcomes (BIO) Study is a longitudinal study with the short-term objective~     of better characterizing multi-modal outcomes in individuals who have sustained a brain~     injury using a systems medicine approach. Long-term aims include monitoring participants for~     signs of emerging symptoms or age-related vulnerabilities. Identification of abnormality~     profiles for all severity levels of brain injury (from any source) reflects a second~     long-range goal. Third, the investigators will examine and compare physiology between~     Veterans who have sustained a Mild Traumatic Brain Injury (mTBI) with and without persisting~     symptoms and various co-morbidities including posttraumatic stress disorder (PTSD). A control~     group of Veterans who have not sustained a TBI will also be recruited for comparison. Fourth,~     the investigators intend to facilitate the clinical use of advanced methodologies, such as~     brain imaging and tissue measures, with the brain injured (and other populations). Finally,~     the investigators will assess methods of analysis, combination and integration for~     multi-modal data in search of diagnostic profiles. Increased knowledge of injury patterns and~     the trajectory associated with brain injury could contribute to better methods of diagnosis,~     monitoring and, perhaps, treatment.~      This investigation has spawned several sub-studies, one of which was the Validation of Brief~     Objective Neurobehavioral Detectors (BOND) of Mild TBI, which continues. The investigators~     are collaborating with Harvard/Boston Children's Hospital in the Angiogenic Signaling~     Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory~     (ORNL) is integrating BIO Study multi-modal data.~   "
216575|NCT00724594|"~     The purpose of this trial was to find the best dose of N-acetylcysteine (NAC) to decrease~     brain injury in babies exposed to intrauterine infection without causing significant side~     effects.~   "
216582|NCT00724503|"~     This study is a randomized multi-center trial that will assess the effect of adding SIRT,~     using SIR-Spheres microspheres, to a standard chemotherapy regimen of FOLFOX as first line~     therapy in patients with non-resectable liver metastases from primary colorectal~     adenocarcinoma.~      Treatment with the biologic agent bevacizumab, if part of the standard of care at~     participating institutions, is allowed within this study at the discretion of the treating~     Investigator.~   "
216583|NCT00724490|"~     The purpose of the study was to evaluate whether a unilateral Deep Brain Stimulation of the~     right Nucleus Accumbens could lead to a more than 35% reduction of symptoms in patients with~     a treatment resistant Obsessive Compulsive Disorder within two years.~   "
216584|NCT00724477|"~     The main objective of this study is to determine the percentage of patients who met the~     low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin~     monotherapy treatment.~   "
216585|NCT00724464|"~     The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication~     and relapse in participants treated with PegIntron and Rebetol in clinical practice in~     Greece. Participants will not be treated as part of the study. Data on participants treated~     in accordance with approved labeling will be collected retrospectively from approximately 30~     sites in Greece.~   "
216586|NCT00724451|"~     The goal of this study is to elucidate the reasons why patients with chronic hepatitis C~     (CHC) would not be considered eligible for antiviral treatment. The study is conducted in~     common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for~     antiviral therapy will be treated at the discretion of the physician with either~     peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in~     accordance with approved labeling. A secondary objective of this study is to define~     treatment failure and to evaluate the reasons for treatment discontinuation.~   "
216587|NCT00724438|"~     Prior studies examining the pharmacokinetics, safety, and efficacy of the new~     etonogestrel-containing single rod implantable contraceptive device, Implanon, did not~     include women who exceeded 130% of ideal body weight. Yet, as these women comprise a~     significant portion of the U.S. population, studies of Implanon in obese women are essential.~     The proposed study represents an important first step in addressing the lack of data on~     Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women~     during the first 6 months of use and to provide data on the acceptability, side effect~     profile, and ease of insertion, palpation, and removal in these women. We also aim to collect~     samples for future validation studies of the use of the blood spot (finger-stick blood sample~     on filter paper) as a method of determining plasma etonogestrel.~   "
216588|NCT00724425|"~     IPI-493 is a potent inhibitor of heat shock protein 90 (Hsp90) and is orally bioavailable via~     a novel formulation.~   "
216589|NCT00724412|"~     Comparison of two Dry Eye products~   "
216590|NCT00724399|"~     The purpose of this study is to evaluate women's level of knowledge and health practices~     regarding cardiovascular health and identify barriers to appropriate health practice.~   "
216591|NCT00724386|"~     The goal of this study is to determine the feasibility based on toxicity and response rate of~     giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin~     toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine~     added to this combination when followed by Filgrastim and the dose-limiting toxicities of~     this regimen.~   "
216592|NCT00724373|"~     The study is designed as a retrospective data review of medical records from participants~     selected from specialist secondary and tertiary care centers across the United Kingdom (UK),~     specializing in Hepatitis C treatment. The study is non-interventional and is designed to~     identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world',~     including the relation between subgroup characteristics and treatment responsiveness.~   "
216593|NCT00724360|"~     This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive~     B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg~     intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till~     progression. Response and HER2 expression are assessed each month by bone marrow aspirate.~   "
216594|NCT00724347|"~     Many older subjects experience difficulty in understanding speech in noisy environments. Part~     of this problem is related to changes that occur in the ear with age and compromise the~     hearing of high-pitched sounds. Another part of the problem with speech understanding relates~     to changes with age in the neural circuits of the brain that process different speech sounds.~     Evidence suggests that these changes in neural circuits are particularly large if hearing~     loss is present. Thus, while hearing aids may help compensate for hearing deficits by~     amplifying speech sounds, additional treatment is necessary to restore optimal neural~     connections in the brain so that speech sounds can be accurately distinguished from each~     other. We are developing PC-based training programs in an attempt to restore optimal neural~     connections. The current randomized trial will evaluate whether two months of training to~     improve the ability to discriminate different consonant sounds in noise will also improve the~     understanding of continuous speech and enhance auditory memory and other high-level auditory~     functions.~   "
216595|NCT00724334|"~     The purpose of this study is to evaluate the long-term effects of orally administered~     SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001~     study.~   "
216596|NCT00724321|"~     The objective of this study is to determine if single dose administration of inhaled iloprost~     will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve~     arterial oxygenation at rest and during exercise at high altitude.~   "
216597|NCT00724308|"~     The purpose of this study is to evaluate whether a smoking cessation telephone care~     coordination program is effective and feasible in VA Mental Health Clinics.~   "
216598|NCT00724295|"~     This is a post-marketing surveillance of patients with chronic hepatitis C treated with~     PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the~     study is to evaluate the safety and efficacy of the combination therapy. The study will also~     compare the safety profile of the combination therapy among elderly patients and younger~     patients.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
216599|NCT00724282|"~     Available data suggest that obtaining adequate sleep is associated with a better ability of~     the body to use carbohydrates as a source of energy and a lower risk of developing diabetes.~     The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug~     Administration for the treatment of people who complain of trouble falling or staying asleep.~     This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the~     sleep of people with insomnia may also improve the use of sugar in their body.~   "
216600|NCT00724269|"~     The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear~     and use of two marketed multi-purpose solutions.~   "
216601|NCT00724256|"~     The purpose of this study is to evaluate the efficacy of oral ceftibuten for 7 days versus 10~     days in acute pyelonephritis in children.~      The main hypothesis is that the ceftibuten for 7 days will be not inferior to ceftibuten 10~     days in the rate of renal scarring at 6-12 months.~   "
216602|NCT00724243|"~     This study will gather information on the safety and efficacy of patients with rheumatoid~     arthritis (RA) who are starting treatment with infliximab for the first time. Patients will~     be treated in the usual manner according to local guidelines and normal clinical practice.~   "
216603|NCT00724230|"~     The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol~     combination therapy administered to patients with chronic hepatitis C. The study will exclude~     (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with~     low viral load. It is being conducted as a post-approval commitment, in accordance with the~     Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
216604|NCT00724217|"~     To determine the effects of a commercially available dietary modification plus nutritional~     supplement regimen, the Standard Process 21 day Purification Program (SPPP), on serum lipids,~     C-reactive protein (CRP), homocysteine, body mass index (BMI), body weight, blood pressure,~     and heart rate variability (HRV) in normal weight (BMI < 26) and overweight (BMI 26 or above)~     participants who have total cholesterol levels over 180.~   "
216605|NCT00724204|"~     The aim of the trial is to evaluate safety of a follow on formula supplemented with~     Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was~     carried out. Eighty six months old children were recruited by the department of pediatrics of~     Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a~     follow on formula supplemented or not with the probiotic strain during 6 months. Fecal~     samples were obtained at the recruitment, at 3 months and at the end of the trial. In~     addition revision by the pediatrician was performed once a month and possible adverse effects~     were recorded both by the pediatrician and by parents.~   "
216606|NCT00724191|"~     The purpose of this study is to determine if new MRI methods that measure various information~     and chemical makeup in the brain, will give early information regarding response to treatment~     in patients with brain tumors.~   "
216607|NCT00724178|"~     We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations,~     is common in children and adolescents with HIV infection. To determine whether vitamin D and~     calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in~     HIV-infected children and adolescents, we propose a double-blind, randomized,~     placebo-controlled trial comparing supplementation with oral vitamin D and calcium to~     placebo.~      The specific aims of this project are to:~        1. Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in~          HIV-infected children.~           We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected~          children who receive supplementation with vitamin D and calcium. This hypothesis will be~          tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry~          (DXA), after one and two years of treatment in HIV-infected children and adolescents~          receiving vitamin D and calcium supplementation compared to those receiving placebo.~        2. Determine the effect of HIV infection and vitamin D and calcium supplementation on~          indices of mineral metabolism and markers of bone turnover.~           We hypothesize that indices of mineral metabolism and markers of bone formation and~          resorption will return toward normal in HIV-infected children and adolescents who are~          randomized to receive vitamin D and calcium supplementation. We will test these~          hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone~          turnover markers in HIV-infected children and adolescents receiving vitamin D and~          calcium supplement versus those receiving placebo~        3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and~          adolescents receiving HAART.~      We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an~     important determinant of bone mass in HIV-infected children and adolescents receiving HAART.~     We will test this hypothesis by evaluating whether measurements of bone mass are associated~     with vitamin D stores, as measured by serum 25-hydroxyvitamin D levels and other indices of~     mineral metabolism, in treated HAART-treated HIV-infected children and adolescents.~   "
216608|NCT00724165|"~     The overarching goal of this project is to develop a culturally congruent intervention to~     increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women).~     The first phase will involve culturally and linguistically modifying an existing~     evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive~     Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial~     to test whether the culturally-modified individually tailored intervention increases physical~     activity levels in comparison to standard care comprised of bilingual health education~     booklets.~   "
216609|NCT00724152|"~     This study examined how useful it is to teach veterans coping skills for dealing with~     tinnitus, also called ringing in the ears. A psychological intervention, cognitive-behavioral~     therapy, was used to teach coping skills even though tinnitus is not a psychological~     disorder. Participants in Period 1 of the study were assigned to one of two groups for the~     duration of the study and were blinded to their group assignment until the end of the study.~     One group received education about tinnitus. The other group received education about~     tinnitus plus additional ways to cope with problems associated with tinnitus such as sleep~     disturbance and frustration. Participants were selected to participate if their tinnitus was~     severe and they had been exposed to loud sound. Participants attended up to six weekly group~     meetings. It was predicted that participants who were randomly assigned to the cognitive~     behavioral therapy group would report a greater reduction in tinnitus severity than education~     controls. During Period 2 of the study, a third standard care arm was added. Baseline and~     outcome data of the 4 participants who completed the study after this third arm was added to~     the study design are not reported.~   "
216610|NCT00724139|"~     The aim of this study is to evaluate the outcome of specific repetitive biomechanical~     perturbation training on motor patterns.~      The first hypothesis of this project is that footwear derived biomechanical challenges will~     convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and~     electromyographic) trough out the musculoskeletal kinematic chain.~      The second hypothesis of the project is that repetitive exposure to in-situ (trough out the~     gait sickle) introduction to a biomechanical stimulus would generate a process of motor~     learning thus conveying plasticity of existing locomotor patterns and gait strategies.~   "
216611|NCT00724126|"~     To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in~     providing adequate relief of IBS symptoms.~   "
216614|NCT00724087|"~     The use of energy from food changes when people sleep. However, it is still not known if~     differences in the amount of nighttime sleep have an effect on the amount of energy that~     people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to~     perform their daily activities. This study is being done to test the hypothesis that the~     daily use of energy in people who have a history of type 2 diabetes in their family will be~     different after they have slept short hours for 16 days in comparison to when they have slept~     longer hours for 16 days.~   "
216615|NCT00724074|"~     The main purpose of this study is to determine if there is improvement in pain and other~     patient outcomes when using a continuous wound analgesia system after total knee replacement,~     compared to usual methods of pain control. Another purpose is to determine if the system~     makes it easier for nurses to care for these patients.~   "
216616|NCT00724061|"~     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells and slow the~     growth of mycosis fungoides/Sezary syndrome. Ultraviolet light therapy uses a drug, such as~     psoralen, that is absorbed by cancer cells. The drug becomes active when it is exposed to~     ultraviolet light. When the drug is active, cancer cells are killed. Giving PEG-interferon~     alfa-2b together with ultraviolet light therapy may kill more cancer cell.~      PURPOSE: This is a pilot study of dose-escalating pegylated IFN-α-2b and PUVA or NB-UVB. The~     purpose is to study the side effects and best dose of PEG-interferon alfa-2b to be given~     together with ultraviolet light therapy in patients with stage IB, stage II, stage III, or~     stage IVA mycosis fungoides/Sezary syndrome (CTCL).~   "
216617|NCT00724048|"~     The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic~     treatment of Huntington's Disease.~   "
216618|NCT00724035|"~     This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia~     using two different nerve block techniques.~      Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below~     the collarbone) blocks will be performed to patients undergoing upper limb surgery.~      The investigators will analyze how long it takes for anesthesia to be adequate for pain-free~     surgery, thus determine the optimal technique for this kind of surgery.~   "
216619|NCT00724022|"~     Current practice of immune suppressive standard therapy after renal transplantation in~     non-risk patients is a triple therapy consisting of steroids, a calcineurin inhibitor and~     MMF. The aim of this clinical trial is to combine a reduction of CNI using tacrolimus and a~     concept of not using steroids in order to establish an immunosuppressive regimen in~     immunologically non-risk patients that is efficient and causes as few side effects as~     possible.~   "
216620|NCT00724009|"~     For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a~     conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia~     blast percentage) at the time of HCT. This should lead to reduced relapse while still~     maintaining low transplant related mortality.~   "
216621|NCT00723996|"~     The overall goal of the proposed research is to explore behavioral correlations between~     colorectal cancer screening and screening mammography.~   "
216622|NCT00723983|"~     To compare the pharmacokinetics of NP101 with a currently approved oral formulation of~     Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a~     non-migraine period.~   "
216623|NCT00723970|"~     The study was designed to examine the efficacy and tolerability of quetiapine XR for the~     treatment of women who suffer from depression in the context of the menopausal transition and~     postmenopausal years. Besides the improvement of depressive symptoms, the investigators are~     interested in examining the impact of this medication on vasomotor symptoms (hot flashes,~     night sweats), sleep and overall quality of life.~   "
216624|NCT00723957|"~     The purpose of this study is to determine whether progression-free survival with ixabepilone~     is superior to that achieved with paclitaxel plus carboplatin in participants with advanced~     nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.~   "
216625|NCT00723944|"~     This prospective, randomized study evaluates the performance and crestal bone changes~     difference between the Osseotite Certain Prevail vs the non-lateralized design of the~     implant.~      Study (null) hypothesis: the crestal bone changes that take place after placement and loading~     of the Osseotite lateralized implants will be the same as for similar but non-lateralized~     Osseotite Certain implants.~   "
216626|NCT00723931|"~     Surveillance will be conducted at digestive departments of internal medicine in university or~     general hospitals where participants with chronic hepatitis C are generally treated. The~     purpose of this surveillance is to evaluate the postmarketing safety and efficacy of~     PegIntron Injection under actual conditions of use and to examine adverse events, serious~     adverse events, and adverse drug reactions.~   "
216627|NCT00723918|"~     The purpose of this study is to evaluate the effectiveness of methadone alone and in~     combination with SAB378 for the treatment of painful HIV-associated neuropathy.~   "
216628|NCT00723905|"~     Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year,~     starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade~     Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective,~     observational program that will gather and analyze data on subjects being treated with~     infliximab.~   "
216629|NCT00723892|"~     Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles,~     anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur~     during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue~     their treatment early. The goal of this study is to assess whether a psychotherapy support~     program may contribute to a better adherence rate.~   "
216630|NCT00723879|"~     Patients receiving a patient assistance program during therapy for Hepatitis C will be~     enrolled into this study. All patients will receive PegIntron and Rebetol (according to the~     label) and the patient assistance program, which includes (1) medications used for treatment~     (psychiatric medications); (2) other interventions (nurse support); and (3) educational~     literature. This study will be compared to similar studies from other clinics using various~     patient support programs for the purpose of designing future comparative phase IV studies.~   "
216985|NCT00719108|"~     The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard~     to its total and to its maximum serum insulin concentrations.~   "
216631|NCT00723866|"~     Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy~     (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined~     application of the two modalities has rarely been studied. The aim was to investigate whether~     combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity~     function than BtxA plus conventional rehabilitation in chronic stroke patients with upper~     extremity spasticity.~   "
216632|NCT00723853|"~     The purpose of this research study is to evaluate two nutrition and exercise programs in~     children ages 9-12 who are at risk for developing type 2 diabetes. This study also includes~     the involvement of parents or guardians who are willing to participate in these programs with~     the child.~   "
216633|NCT00723840|"~     This observational study will evaluate the social cost and quality of life of participants~     who have had Crohn's Disease for at least 6 months and have active disease despite drug~     therapy. Participants are followed for a total of 18 months.~   "
216634|NCT00723827|"~     The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of~     Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the~     following points that are in question and doubt:~        -  Incidence of adverse events under actual conditions of use (Serious and Nonserious~          Adverse Events);~        -  Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected~          Adverse Reaction);~        -  Adverse Event caused by misuse, abuse, or drug interactions;~        -  Other information concerned with safety or efficacy.~   "
216635|NCT00723814|"~     To monitor the blood pressure level of the patient~   "
216636|NCT00723801|"~     Marfan syndrome is an inherited connective tissue disorder with morbidity and mortality from~     aortic dilation and dissection. The degree of aortic dilation and response to beta-blockade~     (standard of care) vary in adults with Marfan syndrome. However, aortic stiffness is often~     present, and can be a predictor of aortic dilation and cardiovascular complications. In~     addition, adults with Marfan syndrome develop left ventricular diastolic dysfunction, which~     can progress to heart failure. Aortic stiffness and diastolic dysfunction are important and~     logical therapeutic targets in adults with Marfan syndrome.~      TGF-beta mediates disease pathogenesis in Marfan syndrome and contributes to aortic~     stiffness. The angiotensin receptor blocker, losartan, inhibits TGF-beta activity and~     reverses aortic wall pathology in a Marfan mouse model. Losartan also decreases aortic~     stiffness and improves diastolic function in hypertension, renal disease and hypertrophic~     cardiomyopathy.~      This trial is a randomized, double-blind trial of 50 adults with Marfan syndrome, treated~     with 6 months of atenolol vs. losartan. Arterial tonometry for aortic stiffness and~     echocardiography for diastolic function will be performed at the beginning and end of~     treatment. A blood draw for serum markers of extracellular matrix turnover and inflammation~     will also be performed at 0 and 6 months. We plan to determine whether losartan decreases~     aortic stiffness and left ventricular diastolic dysfunction significantly more than atenolol.~   "
216637|NCT00723788|"~     Study to find out if MRI can diagnose appendicitis in children as well as or better than CT~     scan and/or ultrasound scan performed at the same time. No additional contrast material or~     sedation will be used to perform the MRI.~   "
216638|NCT00723775|"~     To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and~     without KALETRA (LPV 400 mg/RTV 100mg) q12h~   "
216639|NCT00723762|"~     The purpose of this study is to investigate potential mechanisms of valproic acid-associated~     low serum albumin in medically fragile pediatric and young adult epileptic patients of a~     long-term care facility.~   "
216640|NCT00723749|"~     The aim of this post marketing surveillance study is to investigate the retention rate after~     12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid~     dependent patients under real life conditions.~   "
216641|NCT00723736|"~     The objective of this non-interventional study is to evaluate the safety of Aerius syrup in~     pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria.~     The patients will receive 2.5 ml (1.25 mg) once daily.~   "
216642|NCT00723723|"~     This observational study is being conducted in patients receiving statin treatment as~     secondary prevention of coronary heart disease under the current standard of care in~     compliance with European guidelines. The purpose of the study is to evaluate the percentage~     of these patients that reach target LDL levels. Additionally this study will measure the~     patient's compliance to treatment as assessed by counting the returned tablets. Both~     assessments will be made at visits conducted 6-8 weeks after the first visit and 28-32 weeks~     after the first visit.~   "
216643|NCT00723710|"~     Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment~     with high-dose Intron A for one year. The objective of this study is to maximize treatment~     compliance by proactive management of side effects in a day-to-day healthcare setting.~   "
216644|NCT00723697|"~     The purpose of this study is to assess the risks of abuse, misuse and adverse events related~     to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or~     its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this~     study. Data will be collected using physician questionnaires and self evaluation patient~     questionnaires at the first visit and visits at 6 and 12 months.~   "
216645|NCT00723684|"~     Background:~      Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to~     patients with ADHD in several mostly uncontrolled studies with relatively small sample sizes.~     It is unknown how EEG-neurofeedback affects brain functioning and exerts therapeutic effects~     in ADHD. This study is designed to examine the efficacy and safety of EEG-neurofeedback in a~     scientific rigorously way and to study the underlying neurobiological mechanisms of~     EEG-neurofeedback.~      Objectives:~        1. To investigate the efficacy of EEG-neurofeedback in reducing behavioral symptoms of~          ADHD.~        2. To investigate whether EEG-neurofeedback is able to improve neurocognitive functioning.~        3. To investigate whether EEG-neurofeedback is able to improve neural functioning.~      Study design:~      Double-blind randomized placebo-controlled treatment study.Study population: 120 subjects~     with ADHD (age 8-15, IQ of 80 or more). Intervention: 60 subjects with ADHD receive 30~     sessions EEG-neurofeedback, and 60 subjects with ADHD receive placebo EEG-neurofeedback.~      Main study parameter: ADHD-DSM-IV rating scale, rated by the investigator.~      Hypothesis:~      The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD.~   "
216646|NCT00723671|"~     The purpose of this study is to find out if certain types of Magnetic Resonance (MR) scanning~     will help to better detect markers in the brain that are related to the neuropsychiatric~     symptoms of systemic lupus erythematosus (SLE). A small percentage of patients who have this~     type of lupus experience symptoms that may result from a blood clot or change in blood vessel~     structure in the brain. These neuropsychiatric symptoms can include an inability to think~     clearly, a change in level of awake and/or awareness, and in the worst cases, seizure and~     stroke. Another goal of the study is to find out if individuals with fibromyalgia (FM), or~     chronic pain, have symptom-related markers in any of these scans as well. Better and earlier~     detection of markers that are related to acute neuropsychiatric lupus (NPSLE) and FM will be~     helpful to all who are affected by these diseases.~   "
216647|NCT00723658|"~     RATIONALE: Sometimes the cancer may not need treatment until it progresses. In this case,~     observation may be sufficient. Giving combination chemotherapy together with bortezomib,~     thalidomide, and rituximab before an autologous peripheral stem cell transplant stops the~     growth of cancer cells by stopping them from dividing or killing them. Giving~     colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the~     blood so they can be collected and stored. More chemotherapy is then given to prepare the~     bone marrow for the stem cell transplant. The stem cells are then returned to the patient to~     replace the blood-forming cells that were destroyed by the chemotherapy.~      PURPOSE: This observational and phase II trial is studying how well giving combination~     chemotherapy together with bortezomib, thalidomide, and rituximab followed by two autologous~     peripheral blood stem cell transplants works in treating patients with Waldenstrom~     macroglobulinemia.~   "
216648|NCT00723645|"~     This is an observational, multicenter, nationwide study where information will be collected~     on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral~     response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus~     ribavirin (RBV) administered according to the directions on the products' labeling. No~     administration of treatment is planned as a result of study enrollment.~   "
216649|NCT00723632|"~     The objective of the study is to evaluate the costs associated with peginterferon alfa-2b~     (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic.~     Only costs associated with rescue medication, concomitant therapy, disease monitoring, and~     medical intervention costs recognized by the treating institution as treatment-related~     expenses will be included in the analysis. The study will also evaluate the correlation~     between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant~     history.~   "
216650|NCT00723619|"~     Synopsis: LUNOKID-Study~      Investigation of Lung function Normal Values in Children and Adolescent in Germany~      For the diagnostic work-up of childhood airway diseases lungfunction measurements play an~     important role. As childhood represents a period of continuous development and growth, not~     only is body size and weight increasing and body composition changing with age, but also is~     the lung developing both in size and airway differentiation. Results from lung function~     measurements in children and adolescents have thus to be related to lung function data which~     have been determined in a normal healthy age-matched childhood population. The quality of the~     reference values is therefore crucial for the interpretation of lung function results.~      The reference values for children that are used today have been created between around the~     1970th or 1980th, although the development and body size of children in the last decades has~     considerably changed and accelerated.~      The aim of the LUNOKID study is to create new reference values for lung function measures in~     healthy children aged 4 to 18 years. Measurements will be performed in schools and~     kindergartens in 3 regions of Germany (Wesel, Düsseldorf, Hannover).~      A modified ISAAC questionnaire will be distributed to the parents to get information on the~     family´s and child´s health history with regard to atopy, airway diseases or other diseases~     that could influence the lung function results. A clinical examination on the day of lung~     function performance should exclude acute infections or other diseases. Parents will have to~     give informed consent to the study.~      Study personal, especially trained in the lung function unit of the University Hannover, is~     going to do all examination and lung function measures during the normal school hours at the~     sites of the schools and kindergartens.~      The following measurements will be performed according to the respective SOPs:~        -  Body weight and hight~        -  Exhaled NO, using the NIOX -MINO in children from the age of 5 years onwards, in 4 years~          old children using the off-line method (both Aerocrine)~        -  Spirometry including Flow volume curves (Parameter FEV1, FEV0.5, FEV 0.75, PEF, FVC, MEF~          25, MEF 50, MEF 75) using a Spirometer by the company ndd Medizintechnik AG, Zürich~        -  Ultrasonic pneumography (UPG) (tidal breathing), ndd Medizintechnik AG, Zürich~      It is planned to have 50 valid measurements per gender and age group. Considering that about~     50 % of the children (and 50-75% of the 4 years´old) have to be excluded for the normal~     reference analysis either for health reasons or because the lung function measurement cannot~     be correctly performed. The investigators therefore calculate to included in the study around~     3300 children.~      All data will be gathered and managed in a central database in the IUF in Düsseldorf. The~     statical analysis will include regression analyses to calculate the reference values.~      It is planned to have the new reference values included in the guidelines for diagnostic and~     management of asthma in childhood, and in the software of lung function equipment. By now,~     the study is approved by the Ethical Committee responsible for the PI in Wesel.~   "
216651|NCT00723606|"~     This local registration study is to confirm the hypothesis of the efficacy, tolerability and~     safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in~     schizophrenia~   "
216652|NCT00723593|"~     This study will determine the best location to biopsy the gastrointestinal (GI) tract for~     early and accurate diagnosis of GI graft-versus-host-disease (GVHD). (A biopsy is the~     surgical removal of a small piece of tissue for examination under the microscope.) GVHD is a~     life-threatening complication of stem cell transplantation in which the donor s immune cells~     destroy the patient s healthy tissues. It most commonly affects the skin, liver and GI tract.~     This study will establish where to best biopsy tissue from the GI tract and study the tissue~     to try to explore how GI GVD occurs and how it may be possible to better diagnose and treat~     it.~      Patients 18 years of age and older who have undergone or are who will undergo stem cell~     transplantation and who are at high risk for developing GI GVHD may be eligible for this~     study. Participants may enter the study before the transplant procedure or later if they~     develop GVHD symptoms.~      Participants undergo the following tests and procedures:~      I. Before starting conditioning chemotherapy or radiation therapy for the transplantation~        -  Medical history and physical examination~        -  Sigmoidoscopy (endoscopy of the lower part of the large intestine) and biopsies~        -  Blood draw~        -  Stool sample collection~      II. Two to 3 weeks after conditioning regimen~        -  Sigmoidoscopy with biopsies~        -  Blood draw~        -  Stool sample collection~      III. 30, 45, 60 and 90 days after transplantation~      -Blood draw~      IV. After completing the tests in part II and at the appearance of GI symptoms suspected to~     be due to GVHD~        -  Updated medical history and physical examination~        -  Esophagogastroduodenoscopy (endoscopy of the esophagus, stomach and upper small~          intestine)~        -  Colonoscopy (endoscopy of the entire part of the large intestine) with biopsies~        -  Blood draw~        -  Stool collection~      V. Two weeks after starting therapy in patients diagnosed with GVHD~        -  Sigmoidoscopy with biopsies~        -  Blood draw~        -  Stool sample collection~        -  PET/CT scan in selected patients (nuclear medicine and x-ray imaging of the GI tract~   "
216653|NCT00723580|"~     The study examines and illustrates the utility of utilizing actigraphic measurements to~     assess treatment response.~   "
216654|NCT00723567|"~     The purpose of this study is to find a gene or its mutation (an altered gene) that puts~     individuals at risk for developing HE or HPP.~   "
216655|NCT00723554|"~     A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension~     Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From~     Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)~   "
216656|NCT00723541|"~     The purpose of this study is to develop a computer-aided diagnosis system to find breast~     lesions, including masses and microcalcifications, which hopefully will improve breast cancer~     detection and classification.~   "
216657|NCT00723528|"~     The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275)~     compared with placebo in participants with moderate to severe plaque type psoriasis.~   "
216658|NCT00723515|"~     The study hypothesis is the difference in therapeutic effect of two varnish formulations (G1~     = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2). These products are commercially available in the~     Brazilian and international market and they are used for dental caries as white spot lesions~     control.~   "
216659|NCT00723502|"~     The primary objective of this study is to compare the H. pylori eradication rates with~     Finafloxacin in combination with Amoxicillin or Esomeprazole.~      The secondary objective is to evaluate and compare the safety and tolerability of multiple~     oral doses of Finafloxacin plus Amoxicillin versus Finafloxacin plus Esomeprazole.~   "
216660|NCT00723489|"~     The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to~     reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination in~     those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in~     individuals with AD increases the risk of EV, a yellow fever vaccine was chosen. The purpose~     of this study is to determine the immune response to a yellow fever vaccine in adults with~     AD.~   "
216661|NCT00723476|"~     This study will examine the efficacy of Family Centered Advance Care Planning in enhancing~     quality of life, integrating effective end-of-life care, and preventing depression and~     anxiety among HIV infected adolescents and their family members.~   "
216662|NCT00723463|"~     The purpose of this study is to determine normal measurements (ADC values) from the head and~     neck of healthy volunteers using 3T MRI.~   "
216663|NCT00723450|"~     The study will be a multi-center, parallel, group, placebo control, double-blind, randomized~     controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged~     10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen~     (approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36 weeks)~     and Taper and follow-up phase (up to 4 weeks).~   "
216664|NCT00723437|"~     Objective:~      Efficacy of systemic retinoid therapy of nail psoriasis has never been assessed objectively.~     Evaluate therapeutic efficacy of acitretin in patients with isolated nail psoriasis.~      Design:~      Open-study on thirty-six patients with moderate to severe nail psoriasis treated with~     acitretin.~      Participants:~      Patients included 27 men and 9 women (mean age 41) with nail psoriasis. Intervention: Therapy~     consisted of acitretin 0.2 to 0.3 mg/Kg/day for 6 months.~      Main Outcome Measure(s):~      Clinical evaluation, NAPSI and modified NAPSI scores before therapy, every 2 months during~     therapy and 6 months after treatment.~   "
216665|NCT00723424|"~     The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the~     pharmacokinetics of digoxin (single dose administration).~   "
216666|NCT00723411|"~     The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is~     effective in preserving the body's own insulin producing capacity in patients recently~     diagnosed with type 1 diabetes.~   "
216667|NCT00723398|"~     The overall hypothesis is that the combination of a low dose of the antiestrogen Raloxifene~     with omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect due to~     the crosstalk of their downstream cellular effects leading to decreased proliferation and~     increased apoptosis of premalignant mammary cells. Based on the investigators hypothesis that~     upregulation of functional estrogen receptors in the premalignant lesions is also responsible~     for the development of hormone independent tumors, the investigators postulate that the~     combination of antiestrogens and omega-3 fatty acids will reduce the development of both~     hormone-dependent and -independent tumors. At present, there are no known interventions able~     to decrease the development of hormone-independent tumors, which are more prevalent, more~     aggressive, leading to the patient's demise. In addition, the investigators postulate that~     this approach will be safe since it will combine a lower and hence a less toxic dose of~     Raloxifene with the administration of omega-3 fatty acids which are known to have health~     benefits, i.e., reduction in cardiovascular risk, beyond their possible chemo preventive~     effect in breast cancer.~   "
216668|NCT00723385|"~     The purpose of this study is to examine whether oral vitamin D supplementation in people with~     inadequate vitamin D concentrations will lower LDL-cholesterol and total cholesterol~     concentrations.~   "
216669|NCT00723359|"~     This Phase I research study is to test the effects (good and bad) and best dose of BT062 in~     treating patients with relapsed or refractory multiple myeloma.~   "
216670|NCT00723346|"~     Primary objective :~        -  To explore the relation between 3 doses of GRASPA and duration of asparagine depletion~          (< 2µmol/l)~      Secondary objective :~        -  Pharmacokinetic / Pharmacodynamic parameters~        -  toxicity~        -  Study duration : 2 years~        -  Study treatment : Red blood cells loaded with L asparaginase versus native L~          asparaginase~        -  Associated treatments : COPRALL chemotherapy~        -  Randomization : centralised randomisation on scratching list~   "
216671|NCT00723333|"~     We will evaluate the records of 30 patients that have undergone allogeneic transplant,~     specifically looking at engraftment rate, relapse rate, disease free survival, overall~     survival, causes of death and other pertinent statistics. We will compare the outcomes to~     appropriate historical controls.~   "
216672|NCT00723320|"~     The purpose of this study is to determine whether atorvastatin, aggressive lifestyle~     intervention, and their interaction are effective in delaying the progress of pre-clinical~     atherosclerosis.~   "
216673|NCT00723307|"~     Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary~     heart disease and on standard cardiovascular risk reducing agents including statins will have~     a beneficial impact on carotid artery atherosclerosis compared to placebo.~      Rationale: Once subjects have a heart attack, they remain at much higher than average risk of~     another heart attack and stroke, despite the best current therapies to lower their~     cholesterol and blood pressure and thin their blood. Many subjects with heart disease also~     have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There~     is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk~     of future heart attacks in diabetic patients. However, whether metformin further reduces the~     risk of heart disease beyond established treatments in people without diabetes is unknown.~      Method: The investigators will test the ability metformin, a drug with proven safety, to slow~     the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic~     subjects with heart disease. This will be achieved by treating 2 groups of subjects with~     metformin and placebo pills respectively. To measure atherosclerosis, the investigators will~     carry out ultrasound scans of the big blood vessels in the neck at the start of the study,~     after 1 year and after 1.5 years of therapy.The investigators will then be able to assess~     whether metformin has had a beneficial impact.~   "
216674|NCT00723294|"~     This phase II trial is studying how well cryoablation therapy works in treating patients with~     invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be~     an effective treatment for patients with invasive ductal breast cancer.~   "
216675|NCT00723281|"~     The overall goal of this study is to determine if non-invasive imaging with state of the art~     CT coronary angiography can be used to screen for transplant coronary artery disease in the~     setting of heart transplant.~      Our current protocol at UCSF for heart transplant patients involves screening with stress~     tests as well as coronary angiograms with intravascular ultrasound to assess the diameter of~     the lumen of the coronary arteries and to assess wall thickness.~   "
216676|NCT00723268|"~     The purpose of this study is to determine whether low doses of prednisolone, or colchicine~     are effective in the treatment of oral aphthae.~   "
216901|NCT00720239|"~     The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by~     chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that~     causes ulcers to develop on the lower legs. This new dressing is hoped to help the ulcers~     heal more quickly. The study hypothesis is to determine whether the TalidermR Wound Dressing,~     a poly-N-acetyl glucosamine (pGlcNAc) derived membrane material expedites wound healing in~     humans with venous stasis ulcers.~   "
216677|NCT00723255|"~     This phase II trial is studying the side effects of giving bevacizumab together with~     temsirolimus and to see how well it works in treating patients with recurrent or persistent~     endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for their growth. Giving~     bevacizumab together with temsirolimus may kill more tumor cells.~   "
216678|NCT00723242|"~     The role of the dendritic cells, the most potent antigen presenting cells, in the~     establishment of chronic hepatitis C is not established. The study aims to define whether the~     dendritic cells are affected by the hepatitis C virus and whether that bears an impact on the~     antiviral immune response they generate. The hypothesis is explored by investigating a group~     of patients prior to and after the initiation of standard treatment for hepatitis C with~     pegylated Interferon and Ribavirin.~   "
216679|NCT00723229|"~     We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in~     patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID)~     for HSV-2 suppression compared to taking no medication to better define the effect of~     acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized,~     open label, cross-over trial. We hypothesize that short bursts of HSV-2 reactivation will not~     be suppressed by acyclovir.~   "
216680|NCT00723216|"~     The primary objective of this study is to evaluate the effects of enoxaparin on venous~     thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing~     curative abdominal cancer surgery. The secondary objective is evaluate the incidence of~     adverse events of enoxaparin in these patients.~   "
216681|NCT00723203|"~     RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying the side effects of panobinostat and to see how well~     it works in treating patients with relapsed or refractory acute lymphoblastic leukemia or~     acute myeloid leukemia.~   "
216682|NCT00723190|"~     The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of~     CLONICEL (clonidine HCl sustained release) when administered chronically under regular~     clinical conditions either as monotherapy or in combination with stimulant therapy to~     children and adolescents with attention deficit hyperactivity disorder (ADHD).~   "
216683|NCT00723177|"~     Repeated use and/or abuse of opioid medications is generally associated with a characteristic~     withdrawal syndrome that develops after cessation of drug administration. The present study~     is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal~     symptoms.~   "
216684|NCT00723164|"~     The goal of this study was to investigate the effects of fentanyl-midazolam premedication~     during sevoflurane induction pertaining to time to loss of eyelash reflex (LER), time and~     conditions of insertion of proseal laryngeal mask airway (PLMA), as well as~     cardio-respiratory data. Participants' anxiety level was also evaluated.~   "
216685|NCT00723151|"~     The purpose of the study is to determine if a more intensive application of communication~     intervention, i.e. 5 hours per week, will result in more frequent intentional communication~     acts, greater lexical density, and a better verbal comprehension level than children who~     receive the same communication intervention only one time per week.~   "
216686|NCT00723125|"~     In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus~     Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in~     HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy~     regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a~     1-sided 95% confidence interval using normal approximation with an expected pCR rate of at~     least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate~     of at least 35%, the investigators will have approximately 70% statistical power to conclude,~     with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will~     accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed~     10%.~   "
216687|NCT00723112|"~     The purpose of the study is to elucidate the causative molecular events responsible for the~     abnormal erythropoiesis in MDS.~   "
216688|NCT00723099|"~     This phase II trial is studying how well umbilical cord blood transplant from a donor works~     in treating patients with hematological cancer. Giving chemotherapy and total-body~     irradiation (TBI) before a donor umbilical cord blood transplant helps stop the growth of~     cancer and abnormal cells and helps stop the patient's immune system from rejecting the~     donor's stem cells. When the healthy stem cells from an unrelated donor, that do not exactly~     match the patient's blood, are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells~     (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and~     after transplant may stop this from happening.~   "
216689|NCT00723086|"~     The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks~     repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic~     hormone refractory prostate cancer.~   "
216690|NCT00723073|"~     Invasive fungal infections are an important cause of morbidity and mortality in patients with~     neutropenia who are receiving chemotherapy for cancer. Early diagnosis of these infections is~     difficult and fever may be the only sign. A delay in treatment while a diagnosis is pursued~     may lead to increased morbidity and mortality. There are now several echinocandins available~     with similar in vitro spectrum of activity. Caspofungin is the only echinocandin Food and~     Drug Administration (FDA) approved for empiric antifungal therapy in febrile neutropenia.~     Although all echinocandin antifungal agents have similar spectrum of activity, there are~     limited data on the use of micafungin in patients with persistent fever and neutropenia (FN).~     In November 2006 the Pharmacy and Therapeutics Committee at Brigham & Women's Hospital / Dana~     Farber Cancer Institute (BWH/DFCI) switched from caspofungin to micafungin as our formulary~     echinocandin. Given the limited clinical data on the use of micafungin as empiric antifungal~     therapy in patients with FN, we sought to evaluate the safety and effectiveness of~     micafungin, compared with caspofungin, for this indication using a sequential cohort analysis~     of patients treated before and after the formulary change at Brigham and Women's Hospital.~   "
216691|NCT00723060|"~     OBJECTIVE: The objective of this study is to compare the effect and safety of conventional~     dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive~     disorder (OCD).~      OVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind,~     Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS:~     Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S & -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events /~     Serious Adverse Events, UKU~   "
216692|NCT00723047|"~     This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude~     Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the~     efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients~     with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège,~     Belgium approved the protocol for each participating centers. Recruitment took place at 12~     sites (11 in France and 1 in Belgium)~   "
216693|NCT00723021|"~     Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in~     patients with asthma~   "
216694|NCT00723008|"~     To find out if Cranial Electrotherapy Stimulation is a useful treatment for people who have~     been burned and have Post Traumatic Stress Disorder. CES may be helpful in giving relief to~     some or all of those symptoms.~   "
216695|NCT00722995|"~     The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit~     than the gastric bypass~   "
216696|NCT00722982|"~     Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis~      In Norway it is annually performed approximately 600 primary and 100 revisions THA.~     Osteolysis around the prosthesis is one of the major difficulties while performing revision~     surgery. C-stem is a triple tapered cemented prosthesis designed to increase the stress and~     strain of proximal femur and thereby decreasing osteolysis. We are planning til include 70~     patients and randomize to C-stem AMT or Exeter prosthesis. Both prosthesis will be combined~     with previously non documented Marathon acetabular prosthesis.~      The result will be followed clinically and with RSA and DXA. Soft endpoint after 2 years~   "
216697|NCT00722969|"~     Patients with advanced or metastatic (stage IIIB-IV) non small cell lung cancer who have not~     received prior chemotherapy will be treated with erlotinib 150 mg once a day and sorafenib~     400 mg twice a day. The objectives of the study are to assess the efficacy and safety of this~     combination treatment. Additional exploratory study objectives are correlation of biomarkers~     and imaging modalities potentially predictive for response and (progression free) survival.~   "
216698|NCT00722956|"~     The purpose of the study is to assess the pharmacokinetics of both AZD5672 (steady-state) and~     atorvastatin (single dose) when co administered in healthy volunteers~   "
216699|NCT00722943|"~     The purpose of this study is to see if daily massage therapy will help premature infants~     respond to stress better, as well as improve their growth and neurobehavioral development.~   "
216700|NCT00722930|"~     To evaluate the complete clinical response rate according to the International Working Group~     criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients~     with high-risk follicular lymphoma with either partial or complete response to R-CHOP~     induction chemotherapy~   "
216701|NCT00722917|"~     The purpose of this study is to evaluate the safety and effectiveness of multiple doses of~     TAK-379, once daily (QD), in subjects with type 2 diabetes mellitus.~   "
216702|NCT00722904|"~     Aortic coarctation is a relatively common cardiovascular condition with high associated~     mortality if not treated. Even with successful repair, however, close follow up is needed as~     late complications can result in significant cardiovascular morbidity. MRI, with is ability~     to provide both anatomic and hemodynamic information, is becoming the imaging option of~     choice for post-intervention surveillance. Time-resolved, three-dimensional phase contrast~     magnetic resonance velocity (4D Flow) profiling enables the acquisition of multidirectional~     blood velocity data. The technique is well suited for evaluation of blood flow patterns in~     the thoracic aorta. By comparing aortic flow patterns in patients status post coarctation~     repair with those of healthy volunteers using 4D Flow, this study intends to characterize~     abnormal flow patterns in these patients with the eventual goal of better understanding and~     predicting late complications so that preemptive intervention may be taken.~      Given the potential use of 4D Flow for evaluation of other types of vascular pathology in the~     aorta and other vascular regions, we hope to investigate the use of the technique on a~     limited basis for a broader population of adult patients. Other research groups have had~     success evaluating peripheral stenoses, as well as intracardiac and intracranial blood flow~     patterns with 4D Flow.~   "
216703|NCT00722891|"~     This study will investigate the ocular response to lens wear in 30 subjects.~   "
216704|NCT00722878|"~     Primary ciliary dyskinesia (PCD), also known as Kartagener syndrome, is a genetic disorder of~     the cilia, which are microscopic hair-like cells. Cilia work to keep the respiratory system~     clean by moving mucus that contains debris to the large airways, where it can be coughed out.~     People with PCD have cilia that do not move properly and therefore are not effective in~     cleaning the respiratory system. This study will determine when PCD starts and how it changes~     over time, specifically in terms of how well the lungs work, what germs grow in lung~     secretions, and how the lungs look on computed tomography (CT) scans.~   "
216705|NCT00722865|"~     The purpose of this research study is to determine the effectiveness and safety of Avastin~     when combined with standard chemotherapy for Hodgkin lymphoma. Avastin works differently than~     standard chemotherapy drugs. It is a type of protein called an antibody which binds to a~     substance called VEGF(Vascular Endothelial Growth Factor). VEGF stimulates the growth of the~     blood vessels that feed tumors and encourages tumor cell growth. VEGF is produced in excess~     by Hodgkin lymphoma cells, and is associated with a poorer outcome in patients with Hodgkin~     lymphoma. When the activity of VEGF is interrupted in multiple other cancer types, the blood~     vessels around the tumor cells die resulting in less nutrient delivery and death to the~     tumor. Blocking of VEGF has also been shown to improve delivery of chemotherapy to cancer~     cells, making standard chemotherapy work better. This trial uses Avastin in combination with~     standard chemotherapy with the goal of improving the cure rate over chemotherapy alone.~   "
216706|NCT00722852|"~     The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg~     ketoprofen in Diractin®.~   "
216708|NCT00722826|"~     Patients with pulmonary regurgitation after surgical correction of ToF over 13 years old will~     be recruited from the UCSF adult congenital heart disease clinic. Since there is no data in~     the literature describing the prevalence of abnormal MRI volumetric and functional parameters~     in asymptomatic patients with PR after ToF repair, a pilot study with 30 patients will be~     conducted. Increase in sample size may be necessary in the future to accurately interpret the~     data. After informed consent is obtained, clinical history and physical examination as well~     as review of old charts will be performed to characterize these patient's clinical status.~     All patients will undertake a graduated supine bicycle exercise test with MVO2 measurement to~     assess exercise capacity.~      MRI studies will be performed in a 1.5 tesla unit. SSFP cine images will be obtained in the~     short-axis plane encompassing the entire heart. Velocity-encoded cine MR images will be~     obtained perpendicular to the direction of blood flow in the main pulmonary artery.~     Volumetric and flow analysis will be performed in a separate dedicated workstation by a~     radiologist. End-diastolic volume, end-systolic volume, ejection fraction, total ejection~     fraction and pulmonary regurgitant fraction will be calculated.~   "
216709|NCT00722813|"~     This is a research study to determine patient preferences between two different diagnostic~     tests; a CT angiogram (CTA) and a catheter angiogram, both of which are used at the~     University to screen for and detect heart disease.~   "
216710|NCT00722800|"~     The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and~     effective for treating hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic~     (long lasting) skin disorder that mostly affects the armpits and groin area. It appears as~     blackheads and one or more red, tender bumps that may enlarge, break open, and drain pus.~     Scarring may result after several attacks of the disease.~      The exact cause of HS isn't known. However, it is believed that the plugging of hair~     follicles and bacterial infection that occur in acne also occur in HS. Many of the~     medications used for treating acne are also used for HS. However, none of the medications are~     consistently effective.~      YAZ is a combination birth control pill. Nearly all birth control pills are made up of a~     combination of estrogen and progestin hormones. YAZ contains ethinyl estradiol (an estrogen)~     and drospirenone (a progestin). People who develop acne have sebaceous glands that are~     over-stimulated by male sex hormones (androgens). Sebaceous glands secrete an oily substance~     into a hair follicle to lubricate hair or skin. The progestin in YAZ actually blocks the male~     sex hormones (androgens) that cause acne. Hormones seem to play a role in HS as the condition~     occurs after puberty. It affects more women than men and HS often gets worse around the time~     a women has her menstrual period.~      YAZ has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne~     in women who desire an oral contraceptive for birth control.~      This study uses a placebo. A placebo looks like the study drug but contains no active drug.~     We use placebos in research studies to learn if the effects seen in research subjects are~     truly from the study drug or from other reasons.~   "
216711|NCT00722774|"~     In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were~     associated with significant morbidity and mortality. It is estimated that, in the United~     States alone, the next influenza pandemic could cause approximately 200,000 deaths and~     750,000 hospitalizations. Thus, the development of a vaccine against potential influenza~     strains has become a priority. The purpose of this study is to determine the safety and~     immune response to an H2N2 influenza vaccine candidate.~   "
216712|NCT00722761|"~     The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and~     effective for treating acne on the trunk (the main part of the body that does not include the~     arms, legs, and head).~      Acne vulgaris is a very common skin disorder. It is caused when oil-producing skin glands~     (sebaceous glands) become plugged. The plug can cause blackheads, whiteheads, pimples, and~     cysts on the face, neck, upper chest, and upper back.~      YAZ is a combination birth control pill. A combination pill means that it is made up of~     more than one major ingredient. Nearly all birth control pills are made up of a combination~     of estrogen and progestin hormones. Estrogens are steroid hormones produced by the ovaries~     responsible for the typical female features. Progestins are steroid hormones produced by the~     ovary and placenta responsible for making the uterus fit for pregnancy. YAZ also contains an~     estrogen called ethinyl estradiol, and a progestin called drospirenone. People who develop~     acne have sebaceous glands that are over-stimulated (that is, the sebaceous glands have~     increased activity) by male sex hormones (androgens). The progestin in YAZ blocks the male~     sex hormones (androgens) that cause acne.~      The study drug being used in this study is called YAZ. It has been approved by the U.S. Food~     and Drug Administration (FDA) to treat moderate acne in women who want an oral contraceptive~     for birth control.~      In this study, YAZ will be compared to a placebo for safety and effectiveness. A placebo~     looks like the study drug but contains no active drug (like a sugar pill). We use placebos in~     research studies to learn if the effects seen in research subjects are truly from the study~     drug or from other reasons.~   "
216713|NCT00722748|"~     This proposal puts forward a research plan to initiate a genetic databank, henceforth~     referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic~     research at Scripps as we strive to stay at the forefront of cardiovascular research in the~     new century. Human subject donation allows for the creation of the proposed genebank.~   "
216714|NCT00722735|"~     To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female~     patients with uUTI.~   "
216715|NCT00722722|"~     Patients planning to have kidney transplantation who are sensitized to their donors have high~     levels of donor specific alloantibodies. High levels of donor specific antibodies put kidney~     transplant recipients at risk for rejection very early after transplant. This study is trying~     to determine if the drug bortezomib (Velcade ™) can reduce donor specific alloantibodies to a~     level that permits kidney transplantation without a high risk for rejection.~   "
216737|NCT00722423|"~     This is a prospective randomized controlled trial comparing two different clinic models for~     patients with hepatitis C. These patients commonly have mental health problems that are~     barriers to receiving HCV treatment. Patients giving informed consent will be randomized to a~     usual care HCV clinic vs. a HCV clinic with the addition of an on-site mental health~     practitioner who will address psychiatric and substance use issues with the goal of enabling~     patients to undergo effective antiviral therapy. The major outcome of the study is the number~     of patients in each group who are cured with antiviral therapy. Patients in both groups~     receive current standard of care.~   "
216716|NCT00722709|"~     Aim:~      The general aim of this research group is to improve the recovery of patients after abdominal~     surgery. The specific aim of this study is to conduct a randomized, double blinded,~     controlled trial to investigate the effect of intra-peritoneal local anaesthesia application~     on postoperative pain and post-operative fatigue. This will be conducted in the setting of an~     enhanced recovery after surgery program (ERAS).~      Methods:~      Patients will be randomised by computer generated random numbers and opaque envelope method.~     In the treatment arm patients will receive 10ml 0.75% ropivacaine diluted to 50mls with 0.9%~     saline soon after the creation of the laparotomy . In the placebo arm, 50mls of 0.9% normal~     saline will be used in a similar fashion. At closure, two small 2mm catheter belonging to the~     On-Q pain buster system will be placed in the peritoneal cavity. This will be attached to a~     pump which will contain either a 0.2% ropivacaine solution or 0.9% saline placebo running at~     4mls/hr for 68 hours. All members involved in patient care (with the exception of one nurse)~     will be blinded to the above. After 68 hours the pump will be stopped and the catheter will~     be removed. Assessment of postoperative pain will be performed by visual analogue scale, and~     fatigue assessment will be done using the Identity Consequence Fatigue Scale (ICFS) at~     various intervals post-operatively. Blood tests for inflammatory markers including glucose,~     cortisol, CRP, albumin and several cytokines as well as local anaesthetic levels will be~     taken.~      Significance to health:~      This method of analgesia administration has not been investigated in open major colonic~     surgery. This trial has wide reaching implications, with the potential to improve pain and~     thus recovery after abdominal surgery.~   "
216717|NCT00722696|"~     The purpose of this study is to evaluate metabolic parameters in previously sedentary~     individuals before and after eccentric endurance training (hiking downwards). Study~     participants will regularly hike downwards over a difference in altitude of 540 meters during~     8 weeks. For the opposite way, a cable car will be used. Metabolic profiles will be obtained~     at baseline and after the 8 weeks period of eccentric endurance exercise.~   "
216718|NCT00722683|"~     The purpose of this study is to determine if breast imaging with ultrasound can be improved~     by using 1) a ultrasound attachment with two transducers and 2) a contrast agent. These~     changes might allow smaller blood vessels to be seen than under the way breast ultrasound is~     usually performed.~   "
216719|NCT00722670|"~     We will iteratively adapt and modify the NC woman-focused intervention (Women's CoOp),~     including the field manual and instrumentation, to focus on pregnant African-American women~     who abuse crack, are currently in substance abuse treatment, and are at risk for HIV or are~     HIV positive. We then will test the newly developed intervention in a Stage IB pilot-sized~     randomized clinical trial (RCT) in a traditional substance abuse treatment clinic to~     determine (a) feasibility; (b) relative efficacy compared with substance abuse~     treatment-as-usual (TAU), across several domains of functioning (e.g., substance use, HIV~     risk behaviors); and (c) the intervention's potential mechanisms of action.~      The specific aims of this Stage IA/B study are as follows:~      Aim 1. To adapt the culturally specific, manualized woman-focused intervention to~     specifically address issues of pregnancy and substance abuse, relationships with men, social~     support, parenting, HIV status, living with HIV, antiretroviral (ARV) treatment, and HIV~     risk-reduction methods for pregnant and postpartum women.~      Aim 2. To compare the relative efficacy of the woman-focused intervention for pregnant women~     relative to standard substance abuse treatment to sustain reductions in substance abuse and~     sexual risk behaviors, maintain retention in drug treatment, reduce violence, and improve~     prenatal care and ARV treatment adherence (as needed) at 3- and 6-month follow-up.~      Aim 3. To explore the intervention's potential mechanisms of action (e.g., by examining the~     mediating effects of changes in knowledge about HIV risk behaviors, psychological distress,~     readiness for change) and moderating factors (e.g., HIV status, age, stage of pregnancy,~     relationships with men) that may influence response to the treatment.~   "
216720|NCT00722657|"~     This study had a descriptive, retrospective, transversal character with quantitative~     approach, which aimed to delineate the social-economics profile of the asthmatic patients~     that used the health service available at the Care Nucleon Medical Integrate (NAMI)~   "
216721|NCT00722644|"~     The primary purpose of this 5-year study is to determine whether a Cognitive Behavioral~     Stress Management (CBSM) intervention, demonstrated to be effective in reducing distress,~     enhancing coping, and maintaining health among HIV+ non-drug abusers (see Schneiderman and~     Antoni, 2000), can be effectively adapted for our target population of culturally diverse,~     HIV+, low-income Recovering Drug Abusers (RDAs). Since the late 1980s, members of our~     research team (i.e., Schneiderman, Antoni, Klimas, Fletcher) have been developing, refining~     and evaluating the effects of CBSM among HIV+ Men who have Sex with Men (MSM). In the~     early/mid 90s, we began to adapt and evaluate the effects of CBSM in other non-drug abusing~     subgroups that were emerging with increasing levels of HIV seroprevalence (e.g., pregnant~     women, African American and Hispanic men and women). After accumulating considerable support~     for the effectiveness of CBSM in these subgroups in the late 90s, our research team (i.e.,~     Malow, Schneiderman, Antoni, Klimas, Page) turned its attention to developing the CBSM for~     one of the most neglected and understudied populations affected by the HIV/AIDS epidemic in~     this country: inner city minority drug abusers. With supplemental funding on two NIH grants~     to conduct formative stage1 pilot research, our project team has been able to develop and~     document the feasibility and potential promise of the CBSM approach adapted/translated for~     RDAs (CBSM-RDA). This application proposes to take the next logical step in continuing this~     work: conducting a 3, 6, 8, 10, and 12 month follow-up outcome study comparing CBSM-RDA with~     a matched attention, time and interest value Health Promotion Comparison (HPC) condition, in~     225 male and 225 female HIV+ RDAs with respect to key biopsychosocial health endpoints:~     distress (i.e., depressive symptoms, and mood state), quality of life, drug abuse relapse,~     unsafe sex, Combination Antiretroviral Therapy (CART) medication adherence and health status~     indicators (e.g., Viral Load, CD4 count, physical symptoms).~   "
216722|NCT00722631|"~     There is increasing evidence that inflammation plays a role in progression and~     destabilization of atherosclerotic plaque. FDG-PET can visualize activated metabolic activity~     of inflammatory cells. It is possible that FDG-PET can detect atherosclerotic plaque~     inflammation and that FDG-PET can monitor the effect of pioglitazone on plaque inflammation.~   "
216738|NCT00722410|"~     Infection by Klebsiella pneumonia producing class A carbapenemases is a major clinical and~     public health problem in Israel and worldwide. The aim of this study is to determine the~     safety and efficacy of alteration of the gut microflora by probiotics, alone or in~     combination with mechanical bowel cleansing, as a strategy to eradicate colonization of the~     gastrointestinal tract by CRKP. We hypothesize that administration of probiotics will~     decrease the rate of GI colonization by CRKP.~   "
217718|NCT00709475|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     incidence of serious adverse drug reactions while using insulin detemir under normal clinical~     practice conditions in the Gulf countries~   "
216723|NCT00722618|"~     The primary objective of this trial is to determine whether written educational materials~     plus brief education by telephone will help patients better understand and participate in the~     decision on how many embryos to transfer to the uterus during treatment of infertility with~     in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the~     study's educational intervention will experience favorable changes in knowledge and beliefs~     about benefits, susceptibility and severity of multiple gestation that impact decisions about~     the number of embryos to transfer. Secondary objectives are to understand patient beliefs,~     knowledge and information preferences regarding other possible risks of IVF, to compare~     perception of IVF-related risks to familiar risks that are included in routine preconception~     health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical~     risks when they make the transition to prenatal care after becoming pregnant.~      Medical Treatment Coverage: None, this study does not provide any monetary contribution to~     medical treatment~   "
216724|NCT00722605|"~     The purpose of this study is to use cone-beam CT scans to more accurately position the tumor~     during radiation and to see whether this method is more effective than the standard method of~     using 2D images (portal images), which is a type of X-ray. Cone-beam CT is a type of CT~     scanner attached to the treatment accelerator that produces 3D images of the patient.~      The ability to eliminate the tumor with radiation depends in part on the accuracy of~     delivering the radiation to the lung. The position of the tumor changes because of normal~     breathing. Therefore, we want to improve the accuracy of the way the radiation is delivered~     to the tumor. With cone-beam CT scans taken before and during your treatment, we will be able~     to determine the location of the tumor with 3D images, measure how much the tumor moves as~     you breathe, and then position you so that the tumor will get the best delivery of radiation.~   "
216725|NCT00722592|"~     The objective of this study is to compare progression-free survival (PFS), based upon~     investigator assessment using Response Evaluation Criteria In Solid Tumors version 1.0~     (RECIST 1.0) and clinical findings, in participants with platinum-resistant ovarian cancer~     who receive combination therapy with vintafolide and pegylated liposomal doxorubicin~     (PLD/Doxil®/Caelyx®) with that in subjects with platinum-resistant ovarian cancer who receive~     PLD alone.~   "
216726|NCT00722579|"~     The PRESILLION Study is a non-randomized, multi-center, single-arm study evaluating the~     safety of an approved Cobalt Chromium bare metal stent system for the treatment of ischemic~     heart disease attributable to a stenotic de novo lesion in a native coronary artery.~      The study population will include 100 patients with up to two de novo native coronary artery~     lesions with a maximum lesion length of 30mm in a maximum of two major coronary arteries with~     reference vessel diameter >= 2.5mm and <= 4.0mm by visual estimation. Patients will be~     followed for 1 month and 6 month post-procedure for assessment of MACE and all other adverse~     events.~   "
216727|NCT00722566|"~     Randomized, open-label, international, multi-center, Phase 3 study in which patients are~     randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.~   "
216728|NCT00722553|"~     The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and~     folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study~     will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this~     patient population. Additionally, this study includes the collection of blood samples to~     investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the~     activity of a drug in the body over a period of time, including how the drug is absorbed,~     distributed in the body, localized in the tissues, and excreted from the body).~   "
216729|NCT00722540|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male~     Japanese subjects.~   "
216730|NCT00722527|"~     Our study is designed to characterize the clinical picture and genetic pattern of~     Polycythemia and Thrombocytosis. The purpose of this project is to find a gene and its~     mutation that causes these disorders. When this is accomplished, new therapies to control and~     eventually cure the disorder can be designed.~   "
216731|NCT00722514|"~     Long term disease management is essential for Ankylosing Spondylitis (AS), a chronic~     progressive systemic inflammatory disease of the axial skeleton. Extensive information about~     the disease is a necessary first step. An education program for AS was implemented to improve~     inpatient medical rehabilitation. In a controlled quasi-experimental multicentric study the~     efficacy of this program was analysed.~   "
216732|NCT00722501|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     ascending single IV doses of ERB-257 in healthy subjects~   "
216733|NCT00722488|"~     This is an open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult~     patients with lymphoma or multiple myeloma. The patient population will consist of adults~     with a confirmed diagnosis of lymphoma (Waldenstrom's macroglobulinemia is permitted) or~     multiple myeloma that is relapsed and/or refractory after at least 2 prior standard~     chemotherapeutic regimens and for which no curative option exists.~      Patients in the expansion cohort, Schedule E, must specifically have Hodgkin lymphoma,~     DLBCL-GCB subtype, DLBCL-non-GCB subtype, or Mantle Cell Lymphoma (MCL). Patients with~     multiple myeloma will no longer be evaluated as a part of this study.~   "
216734|NCT00722475|"~     The investigators want to test whether infusions of intravenous immunoglobulin - a blood~     product known to modify immune responses - in early pregnancy will increase the chance of a~     subsequent live birth in women with three or more miscarriages after a birth and a total of~     at least four miscarriages. This will be done in a trial where 82 patients will be randomly~     allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.~   "
216735|NCT00722462|"~     The present study is designed to test the hypothesis that acupuncture, before and after~     embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with~     sham acupuncture and no acupuncture at all.~   "
216736|NCT00722436|"~     This is a randomized, blinded, prospective study that will investigate the potential benefit~     of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric~     patients undergoing craniofacial surgeries.~   "
217755|NCT00708994|"~     The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active~     ingredient of cannabis, on neural synchrony. Neural synchrony is studied using~     electroencephalography (EEG).~   "
216739|NCT00722397|"~     The TODAY study group has prepared a protocol with the primary objective of collecting blood~     and phenotypic information to be used to explore relationships between candidate genes and~     type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular~     complications of insulin resistance. Participation in the genetics study includes a blood~     draw for analysis of diabetes type and DNA extraction, as well as collection of basic family~     and medical history. Appropriate informed consent and assent are obtained from all~     participants to extract DNA and send blood, genetic material, and medical history to the~     Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases~     (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the~     Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the~     scientific community for research that may help in the development of new diagnostic tests,~     new treatments, and new ways to prevent diabetes and other related comorbidities.~   "
216740|NCT00722384|"~     To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal~     injection in patients with wet age-related macular degeneration.~   "
216741|NCT00722371|"~     A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration~     in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.~   "
216742|NCT00722358|"~     The primary purpose of this study is to assess the change in HCV RNA during dosing with~     BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection~   "
216743|NCT00722345|"~     Exercise consultation, an intervention approach based on the transtheoretical model has been~     successful in promoting physical activity (PA) among adults. It is unknown whether this~     approach would be efficacious with youth. The purpose of this pilot study was to assess~     whether exercise consultation would increase PA levels and improve anthropometric measures~     and metabolic markers in obese adolescents.~   "
216744|NCT00722332|"~     The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B~     in combination with antiviral therapy for the prevention of hepatitis B virus (HBV)~     recurrence following HBV-related orthotopic liver transplant.~   "
216745|NCT00722319|"~     Patients on warfarin treatment pose particular problems when undergoing percutaneous coronary~     intervention with stent implantation (PCI-S), because of the poor definition of the optimal~     antithrombotic strategies to be adopted both peri-procedurally and during the 4 (or more)~     weeks after PCI-S, when dual antiplatelet therapy with aspirin and clopidogrel is~     recommended. In the absence of solid evidence-based data, no definite recommendations for the~     management of this patient subset are currently given in the guidelines on percutaneous~     coronary intervention issued by the most prominent Cardiology Associations. Indeed, a high~     variability has been reported in the current antithrombotic strategies, which may consist in~     either the temporary substitution of warfarin by dual antiplatelet treatment or the~     combination of warfarin and aspirin or clopidogrel or both. Peri-procedural bridging therapy~     with either intravenous unfractionated or subcutaneous low-molecular-weight heparin is also~     variably carried out. Purpose of this registry is to determine in patients on warfarin~     treatment undergoing PCI-S: 1) the contemporary peri-procedural and medium-term~     antithrombotic management; and 2) the relative safety and efficacy of the various~     antithrombotic regimens.~   "
216746|NCT00722306|"~     To determine the mass balance of PD 0200390~   "
216747|NCT00722293|"~     This is an open-label, four-arm, Phase I, dose escalation study to evaluate the safety and~     tolerability and to determine the optimal tolerated regimen (OTR) of pazopanib in combination~     with epirubicin or doxorubicin in patients with advanced solid tumors. Patients will be~     enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or~     doxorubicin. Dose escalation schemas for each study arm are described in the protocol. For~     each arm, the OTR will be defined as the highest dose combination of the agents where no more~     than one out of six patients experiences a dose-limiting toxicity. Twelve additional patients~     in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will~     allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed~     using RECIST criteria.~   "
216748|NCT00722280|"~     Overall Goal~      To establish hand transplantation as a safe and effective reconstructive strategy for the~     treatment of upper extremity amputations.~      Specific Aim~      To reduce the risk of rejection and enable allograft survival while minimizing the~     requirement for long term high dose immunosuppression.~      For this purpose, we propose to utilize the Pittsburgh Protocol, which is an~     immunomodulatory strategy that has been implemented in solid organ transplants at UPMC. Early~     results in living related liver and kidney patients have confirmed that this protocol~     provides the means to allow graft survival with minimization of maintenance immunosuppression~     and even allows weaning of some patients from long-term immunosuppression.We hypothesize that~     a similar protocol can enable graft survival in highly immunogenic composite tissue~     allografts like hand transplants while reducing the number,dosing and/or frequency of~     immunosuppressive drugs associated with serious adverse effects.~   "
216749|NCT00722267|"~     This study is investigating how patients with severe stable state COPD perceive the~     variability of their symptoms throughout the day, the week and the year; the impact of these~     variations on their daily activities or sleep quality and how they deal with their~     treatments. For this purpose patients will be asked to answer a questionnaire over the phone~   "
216750|NCT00722254|"~     To determine the prevalence of myelofibrosis in patients with primary pulmonary hypertension,~     and to discover if the fibrosis in these patients is primary (AMM) or secondary.~   "
216751|NCT00722241|"~     The purpose of this study is to evaluate the safety and effectiveness of the next-generation~     DexCom SEVEN Continuous Glucose Monitoring System (SEVEN.2 System) when worn for up to 7-days~     by subjects >18 years-old with diabetes mellitus requiring insulin therapy.~   "
216752|NCT00722228|"~     This study is based on the finding that tumor cells that are grown in the laboratory can be~     modified in such a way that, when injected to the patient, they will stimulate his/her immune~     response. This approach will be evaluated in patients with melanoma and colorectal, gastric,~     ovarian, breast, lung and kidney epithelial cancer. Tumor cells grown in the laboratory will~     be modified to make them stimulatory to the immune system, irradiated to kill them, and~     injected to the patient eight times at two-week intervals. This protocol is expected to~     prolong survival of metastatic cancer patients.~   "
216753|NCT00722215|"~     The number of people with kidney problems is increasing rapidly, related in part to the~     increasing prevalence of diabetes. Patients with kidney problems tend to have protein leaking~     into the urine (proteinuria). Both proteinuria and the kidney disease itself are associated~     with an increased risk of heart disease. Reducing proteinuria is an important treatment goal~     in people with kidney problems. Endothelin is a chemical produced both by blood vessels and~     the kidney. Higher than normal levels of endothelin are thought to contribute to progression~     of kidney disease and proteinuria. By using drugs that block the effects of endothelin~     ('endothelin receptor antagonists') we can hopefully reduce both of these. The purpose of the~     study is to ascertain whether endothelin receptor antagonists improve kidney function and~     reduce proteinuria more so than other commonly used drugs.~   "
216754|NCT00722202|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV~     administered ERB-257 as single ascending doses to healthy Japanese male subjects~   "
216755|NCT00722189|"~     An assessment of the efficacy and safety of Travogen cream and Travocort cream in the~     treatment of local skin mycoses~   "
216756|NCT00722176|"~     A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The~     Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To~     Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum~     Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo~   "
216757|NCT00722163|"~     In the first year of treatment after a FE of SCZ, 75% to 90% of patients achieve remission~     from psychotic symptoms. However, approximately 40% of FE patients are non-adherent to~     medication regimes and more than 60% have intermittent periods of gaps of non-adherence.~     Relapse rates are high with 82% of patients relapsing at least once within 5 years.~     Unfortunately even amongst those who do achieve full remission from psychotic symptoms,~     functional recovery remains a major challenge for patients. All the evidence suggests that~     individuals with SCZ do best with a combination of pharmacology and psychosocial~     intervention. Cognitive-behavior therapy (CBT) is gaining recognition as an effective~     treatment in SCZ and is in fact the only psychosocial treatment in SCZ with proven durability~     at short term follow-up. Although it is currently being used, the investigators need to learn~     more about the impact of CBT on FE SCZ especially as experts are advocating for CBT to be a~     critical component of FE clinical services.~   "
216758|NCT00722150|"~     The purpose of this study is to determine the impact of varying doses of artesunate on~     treatment outcome and whether higher doses of artesunate can overcome the problem of~     compromised artemisinin sensitivity in the region.~      To determine the safety and tolerability of this previously untested experimental high dose~     (6 mg/Kg/D X 7 day, total 42 mg/Kg) artesunate monotherapy regimen.~   "
216759|NCT00722137|"~     This is a randomized, open-label, multicentre, prospective study to compare the efficacy and~     safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly~     diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone~     marrow transplantation.~   "
216760|NCT00722124|"~     Cigarette smoking is of great public health importance and is the single most important~     preventable cause of morbidity, mortality and excess health care costs in the United States.~     After a steady decline for the last 50 years, the prevalence of tobacco use in the United~     States has reached a plateau of approximately 21%. Currently available treatments among~     adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be~     continually developed and tested.~      The release of dopamine in the nucleus accumbens is one of the key components of the~     pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter~     availability (particularly dopamine and norepinephrine) are likely to increase the reward~     function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary~     methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic~     synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and~     norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine~     withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop~     smoking. SAMe is well tolerated and is available over-the-counter.~      To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of~     tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for~     increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized,~     blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial.~     Participants (N=120) will be randomly assigned to one of the three groups, and will receive~     an 8-week course of SAMe 800-mg per day, 1600-mg per day, or a matching placebo. This study~     is anticipated to provide the data needed to develop a larger randomized controlled clinical~     trial submitted through the R01 funding mechanism, if the results appear promising.~   "
216761|NCT00722111|"~     The purpose of this study is to determine whether stroke patients with swallowing problems~     will show greater swallowing improvement with intense oral exercise than subjects who perform~     either a low intensity oral exercise or a sham exercise.~   "
216762|NCT00722098|"~     The purpose of this study is to determine whether the combination of chemotherapy~     (Cyclophosphamide) and CD34-DC vaccines results in the improved rate of clinical responses~     for stage IV melanoma patients.~   "
216763|NCT00722085|"~     Amniotic Fluid Sludge Does Not Increase Risk of Preterm Delivery in Cerclage Patients.~   "
216764|NCT00722072|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Estrogen can cause the growth~     of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking~     the use of estrogen by the tumor cells. Giving sorafenib together with fulvestrant may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving sorafenib together with fulvestrant~     works in treating patients with locally advanced or metastatic breast cancer that did not~     respond to aromatase inhibitor therapy.~   "
216765|NCT00722059|"~     The purpose of this study is to compare 3D mammography with digital mammography in women with~     dense breasts for the detection and evaluation of masses and/or breast cancer.~   "
216766|NCT00722046|"~     Purpose of the study is to determine whether multiple dose administration of PF-04360365 is~     safe and well tolerated in patient with mild to moderate Alzheimer's disease.~   "
216800|NCT00721591|"~     To determine, through pharmacokinetic parameters, the ideal dosing protocol for dalteparin (a~     low molecular weight heparin) and unfractionated heparin for women desiring pregnancy who~     have evidence of an acquired (specifically, antiphospholipid syndrome) or inherited~     thrombophilia.~   "
216801|NCT00721578|"~     To collect and summarize information on the diagnosis, management, and clinical and~     mycological outcomes of patients with systemic fungal infections in order to better~     understand the effectiveness of antifungals in the treatment of Systemic Fungal Infections~     (SFI) in India.~   "
216767|NCT00722033|"~     Very low birth weight infants has increased dramatically their survival. Survival without~     neurologic disturbance varies a lot between centers.There is evidence that fluctuations in~     cerebral blood flow influences the appearance of intraventricular hemorrhage and itself~     implies a detrimental neurologic developing.The electroencephalography is the result of~     electric base membrane activity on rest, and it's influenced by the blood flow either. The~     Amplitude-integrated electroencephalography is a novel tool, that is capable to be~     continuously used at the patient bed and is easily to be read by the trained clinician.The~     hypothesis is that common procedures as Surfactant instilation, Indomethacin and Aminophyline~     infusion as the appearance of apneas alters the aEEG register. It is a prospective study that~     tries to recruit 10 < 30 weeks of gestational age with aprofen consent to monitorize the aEEG~     since birth to the seventh day of live.~   "
216768|NCT00722020|"~     To determine whether or not high frequency chest wall oscillation (in the form of the VestTM)~     is superior to regular asthma therapy in the management of children hospitalized with~     moderate to severe asthma.~   "
216769|NCT00722007|"~     The primary objective of this study is to evaluate the performance of the Cormet Hip~     Resurfacing implant system in the post-approval environment.~   "
216770|NCT00721994|"~     primary endpoint of this Study is maintenance of at least good clinical status for a period~     of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market~     IDE.~   "
216771|NCT00721981|"~     The main purpose of this study is the identification, description, and segmentation of~     non-small cell lung cancer (NSCLC) patients based on their value appraisal of treatment~     outcomes and all intermediate states of health, to obtain patient preferences in direct~     correlation with clinical data from patients suffering from NSCLC (stage IIIB / IV) who are~     in transition from 1st to 2nd line treatment, and to gain utility scores by health state~     derived from patients' perceived value and taken from their perspective.~   "
216772|NCT00721968|"~     To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400~     in conjunction with cataract surgery, compared to cataract surgery only, in subjects with~     mild to moderate open angle glaucoma.~   "
216773|NCT00721955|"~     Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in~     bipolar 1 disorder patients.~   "
216774|NCT00721929|"~     The purpose of this study is to determine if certain MRI sequences can accurately diagnose~     adrenal masses of unknown origin.~   "
216775|NCT00721916|"~     This is a randomized, multicenter study designed to evaluate the progression free survival of~     the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV~     and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.~   "
216776|NCT00721903|"~     The purpose of this study is to determine how well changes can be determined in malignant~     masses from ultrasound scans.~   "
216777|NCT00721890|"~     Green tea is extracted from steam treated leaves, allowing the preservation of catechins, the~     active elements of the infusion. Catechins are recognized for their anti-cancer activity.~     Catechins act on the capacity of cancer to disseminate to other organs because of their~     anti-protease action. Proteases are proteins capable of digesting the cancer environment and~     facilitating the progression of cancer cells to blood vessels which will bring them to~     distant organs. We know that ovarian cancer responds well to the initial treatment of~     chemotherapy but tends to recur rapidly. We intend to provide green tea with higher~     concentrations of catechins to women with complete remission of their ovarian cancer in an~     attempt to delay cancer relapse. We also intend to identify, with molecular technologies, the~     proteases involved in ovarian cancer recurrence and response to catechins. Our objective is~     to test the hypothesis that green tea intake may delay ovarian cancer recurrence and to~     develop tools to predict which women will best benefit of the addition of green tea to their~     initial treatment.~   "
216778|NCT00721877|"~     Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the~     laboratory from participants who are taking resveratrol may help doctors learn more about how~     this drug is used by the body. This phase I trial is studying the side effects of resveratrol~     and to see how it works in healthy adult participants.~   "
216779|NCT00721864|"~     This study is designed to better understand the molecular biology of paroxysmal nocturnal~     hemoglobinuria (PNH) and to determine if prion protein (PrP) functions in long term~     hematopoietic stem cell renewal.~   "
216780|NCT00721851|"~     The primary aim of this study is to determine the potential utility of 320-slice volume-CT~     for obtaining adequate diagnostic accuracy while at the same time improving image quality~     compared with previous generations of CT scanners and simultaneously enabling a reduction in~     both radiation exposure and contrast agent amount required.~   "
216781|NCT00721838|"~     to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery~   "
216782|NCT00721825|"~     TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in~     post-stroke recovery, and to assess the utility of the rehabilitation outcome measure~     instruments used.~   "
216783|NCT00721812|"~     A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of~     GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers~   "
216802|NCT00721565|"~     Translation of the current basic science information related to physical activity into~     patient intervention programs is needed. This translation is critical to providing benefit to~     the maximum number of patients. Little is known about the determinants of physical activity~     among breast cancer patients undergoing hormonal therapy and few studies have attempted to~     evaluate an exercise behavior change program aimed to improve exercise adherence among such~     patients. The proposed project will evaluate use of an innovative behavioral and psychosocial~     intervention to increase physical activity among breast cancer patients.~   "
216803|NCT00721552|"~     The investigators will assess whether the DPP-inhibitor sitagliptin will ameliorate~     glucocorticoid-induced impairment of glucose metabolism and beta-cell dysfunction and thus~     could be used as a prophylaxis for glucocorticoid-induced diabetes. Therefore the~     investigators will administer in males with the metabolic syndrome 30 mg prednisolone daily~     for two weeks and give simultaneously sitagliptin 100 mg daily. Subjects will undergo at~     baseline and after two weeks of treatment several tests to assess changes in glucose~     metabolism.~   "
216784|NCT00721799|"~     This is an imaging protocol only, not a therapeutic study.~      The primary goal of the proposed study is to examine the utility of a new imaging study,~     Positron Emission Tomography with F-18 Fluorothymidine (FLT PET), in the early treatment~     evaluation of head and neck cancer. FLT uptake in the tumor correlates with the rate of cell~     proliferation. It is therefore hoped that changes in tumor FLT uptake after therapy will~     reflect change in the number of actively dividing tumor cells and will provide early~     assessment of treatment response.~      Research subjects will undergo one PET scan with FLT. The scan is done prior to any~     therapeutic intervention (radiation or chemotherapy) can be obtained up to 30 days prior to~     the start of therapy. The uptake of FLT in the tumor will be analyzed to see if it can be~     used as a predictor of treatment efficacy and/or outcome.~      There is an optional biopsy component to this study. Should the attending physicians~     (primarily the otolaryngologists) believe that the subject can safely undergo an outpatient~     biopsy, and the subject agrees, a biopsy is performed. The biopsy will be done within 30 days~     prior to treatment, similar to FLT PET scans. Tissue from the biopsy will be analyzed for~     markers of cellular proliferation and these markers will be correlated with the findings of~     FLT PET scan.~      There will be a 2-year clinical follow-up to assess for treatment outcomes, local control,~     and overall survival.~   "
216785|NCT00721786|"~     The purpose of this study is to determine the percentage of English- and Spanish-speaking~     smokers worldwide who can stop smoking using an Internet stop smoking site.~      Latinos and non-Latinos are welcome to participate.~      We will stop recruitment on March 19, 2011. Participants will be able to use the site until~     May 19, 2011.~   "
216786|NCT00721773|"~     This is a multicentre study examining the effectiveness of angiotension converting enzyme~     inhibitor (ACEI), angiotensin receptor blocker (ARB) or a combination of both in reducing the~     rate of decline in residual renal function (RRF) in continuous ambulatory peritoneal dialysis~     (CAPD) patients.~   "
216787|NCT00721760|"~     The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.]~     injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the~     prevention of Venous Thromboembolic Events [VTE] in patients undergoing hip fracture surgery.~      The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip~     fracture surgery, and to document AVE5026 exposure in this population.~   "
216788|NCT00721747|"~     The purpose of this study is to determine how many pathological complete responses are~     achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide~     (MC) first line treatment in HER2 negative brest cancer patients.~   "
216789|NCT00721734|"~     The purpose of this study is to assess the influence of renal impairment on carfilzomib in~     patients with Multiple Myeloma (MM).~   "
216790|NCT00721721|"~     High blood pressure is a serious health problem. In terms of diet recommendations, people~     with this condition are encouraged to eat a low sodium and high potassium diet. It is~     believed that genetics may play a role in the development of high blood pressure and may~     affect changes in blood pressure levels, including changes brought on by sodium and~     potassium. This study will identify genetic factors that may influence blood pressure changes~     due to increased salt or potassium intake in people with mildly elevated blood pressure and~     in their family members.~   "
216791|NCT00721708|"~     The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the~     healthy adults.~   "
216792|NCT00721695|"~     This is an exploratory study to determine the safety and clinical benefit of OMS302 Injection~     in subjects undergoing Cataract Extraction with Lens Replacement (CELR) using a coaxial~     phacoemulsification process.~   "
216793|NCT00721682|"~     The hypothesis of this study is nonrecognition by the medical team of pain in maltreated~     children. These children would have a particular painful behaviour, quiet. The management~     of their pain would be then unsuited, which could explain their complex relation with the~     pain in the adulthood. A pilot study realized in the CHU of Nantes on 11 files of maltreated~     children showed that they had very low scores of evaluation of the pain, in spite of severe~     traumatisms. There is, at the moment, no data in the literature on the acute pain of the~     maltreated children.~   "
216794|NCT00721669|"~     Primary objective is to evaluate the safety and PK of IMGN388~   "
216795|NCT00721656|"~     To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye~     syndromes.~   "
216796|NCT00721643|"~     The absorption kinetics of polyphenols in angel's plant (Angelica keiskei), which is a dark~     green leafy vegetable rich in antioxidant nutrients, will be determined in older adults in~     this pilot study.~   "
216797|NCT00721630|"~     HER2 is a protein that sits on the surface of breast cancer cells in some people. Because you~     are one of these people, your breast cancer is called HER2-positive. The HER2 protein is~     involved in the growth of your breast cancer. Certain drugs can interfere with the ability of~     the HER2 protein to cause breast cancer growth. Trastuzumab is one of these drugs. You must~     have already received trastuzumab as treatment for your breast cancer to be considered for~     this study.~      Other drugs are being studied in women with HER2-positive breast cancer. Lapatinib (Tykerb™)~     blocks signals that stimulate HER2-positive breast cancers to grow. The FDA approved~     lapatinib for use with capecitabine (Xeloda™) in patients who have metastatic breast cancer~     that has grown or spread after treatment with trastuzumab.~      Capecitabine was approved by the FDA in 1998 for treating metastatic breast cancer.~     Capecitabine is a pill that blocks the way cancer cells multiply and grow. Usually, this~     medicine is taken twice a day for fourteen days. Then, patients do not take the pill for~     seven days. With this schedule and dose, some patients have had side effects that interfered~     with their comfort. We have used mathematical models to recommend a new schedule of~     capecitabine. In animals, 7 days of treatment with capecitabine followed by a 7-day break was~     safer and more active against breast cancer. The purpose of this study is to find out what~     effect (both good and bad) capecitabine has on you and your breast cancer when given in this~     new schedule and combined with lapatinib.~   "
216798|NCT00721617|"~     Although a large number of obese patients develop high blood pressure, the cause is unknown.~     The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the~     development of high blood pressure in obese people.~   "
216799|NCT00721604|"~     The purpose of this study is to verify the accuracy and applicability of predictors of fluid~     administration efficacy in hypotensive critically ill patients.~   "
216805|NCT00721526|"~     The proposed design is a single-group open-label trial. Qualified consenting participants~     with active alcohol dependence and primary or secondary anxiety disorder will receive~     monitored disulfiram and lorazepam, in the context of a structured Medication Management (MM)~     model. In weeks 9-15 lorazepam is tapered, and disulfiram is stopped at the end of week 16.~     Participants who achieve 4 weeks abstinence and meet criteria for a primary anxiety disorder~     or mood disorder may receive ancillary medication consisting FDA-approved non-benzodiazepine~     treatment, with specific options for each disorder described in the protocol. Participants~     requiring continued treatment are referred to clinical treatment in the community at week 16,~     and bridging prescriptions of anxiolytic/antidepressant medication may be provided. A final~     follow-up assessment occurs at week 28. The primary outcomes are Percent Days Abstinent (PDA)~     and retention in treatment. Secondary alcohol outcomes are consequences, drinks per drinking~     day, remission status, and time to first heavy drinking day. Anxiety outcomes are Hamilton~     Anxiety Scale scores and anxiety disorder diagnosis.~   "
216806|NCT00721513|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with~     cetuximab and radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and~     fluorouracil together with cetuximab and radiation therapy works in treating patients with~     locally advanced head and neck cancer.~   "
216807|NCT00721500|"~     This study seeks to evaluate the clinical fitting performance of a new daily disposable~     contact lens to an existing daily disposable contact lens.~   "
216808|NCT00721487|"~     The primary aims of this study are to identify and characterize the immediate consequences of~     patients who fail fluconazole treatment during the treatment of severe infection, and to~     determine if fluconazole failures are more frequently associated with fluconazole-resistant~     or fluconazole-susceptible strains of C. albicans.~   "
216809|NCT00721474|"~     A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.~   "
216810|NCT00721461|"~     A study to evaluate the tolerability of electrostimulation applications with an~     investigational device known as the MedPulser DDS.~   "
216811|NCT00721448|"~     This will be a single centre study conducted at the 3rd hospital affiliated to Peking~     University. Approximately 24 healthy Chinese volunteers, male and female, will be recruited~     to obtain at least 20 evaluable volunteers. The primary objective of this study is to~     characterize the pharmacokinetics of AZD6140 and its active metabolite AR-C124910XX after~     single and multiple (twice daily) doses of AZD6140 90 mg and 180 mg in healthy Chinese~     volunteers. The secondary objective of this study is to determine the safety and tolerability~     of single and multiple (twice daily) 90 mg and 180 mg doses of AZD6140 by physical~     examination, clinical laboratory tests, vital signs, and collection of adverse events in~     healthy Chinese volunteers.~   "
216812|NCT00721435|"~     The study will evaluate and refine a breast screening and diagnosis device.~   "
216813|NCT00721422|"~     1. To investigate the effect of kidney function on the elimination of a single dose of PD~          0332334 from the body.~        2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients~          with impaired kidney function.~   "
216814|NCT00721409|"~     The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess~     the effect of the combination on advanced breast cancer~   "
216815|NCT00721396|"~     Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given~     concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4~     months of age, as measured by percentage of subjects with serum bactericidal activity (SBA)~     titer ≥1:5, at 1 month after the third vaccination Secondary :To demonstrate that~     immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to~     healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant~     vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV~     NZ when given concomitantly with routine infant vaccines was non-inferior to that of~     rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess~     prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at~     baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine~     without rMenB+OMV NZ.~   "
216816|NCT00721383|"~     The purpose of this randomized clinical trial is to test a 12-month multi-component health~     promotion intervention with home-based family caregivers of persons with Alzheimer's Disease~     and other related dementias. Specific aims are to: 1) Test the primary hypothesis: The~     Enhancing Physical Activity treatment intervention will be more effective in increasing~     caregiver lifestyle physical activity than the Standard Care Intervention; 2) Test secondary~     hypotheses: The Enhancing Physical Activity treatment intervention will be more effective~     than the Standard Care Intervention in improving the following caregiver secondary outcomes:~     mental health, physical health and physical function; and 3) Evaluate the process of~     implementing a lifestyle physical activity intervention with family caregivers. The Standard~     Care Intervention focuses on well-established care-related education and support needs. The~     Enhancing Physical Activity treatment intervention focuses on two areas: increasing lifestyle~     physical activity and addressing well-established care-related concerns that are likely to~     interfere with increasing physical activity. A total of 190 middle-age to older~     community-based primary caregivers of persons with Alzheimer's disease or other related~     dementias who report some to moderate strain with caregiving activities will be randomly~     assigned to either the Enhancing Physical Activity or Standard Care Intervention. Data will~     be collected at baseline, 3, 6, 9, 12 and 18 months and include self-report and direct~     observational methods. Data will be analyzed by using repeated measures models using the~     generalized estimating equation approach. Family caregivers are a stressed population who~     experience changes in their mental and physical health. However, effect sizes have been~     minimal for interventions designed to only affect caregiver mental health. No study known to~     us, has tested the added value of physical activity adoption in conjunction with more~     traditional caregiver support and skill building. Study findings will enable us to evaluate~     the behavioral , physical, and health-related quality of life effects achieved by the~     combined intervention; and will add knowledge about the most effective ways of intervening~     with family caregivers and other chronically stressed middle-age and older adult populations.~   "
216817|NCT00721370|"~     Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast~     cancer. We propose a method of SLN mapping based on the use of invisible near-infrared~     fluorescent light that has significant advantages for both patient and surgeon. The present~     study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging~     system.~   "
216902|NCT00720226|"~     Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage~     due to smoking. The goal of this study is to determine whether this drug which is also used~     to treat hypertension can stabilize or improve lung function in people who have from chronic~     obstructive pulmonary disease (COPD).~   "
216818|NCT00721357|"~     Of the ~700,000 persons who suffer a stroke each year, only 50% recover the ability to~     perform unlimited community walking. One mechanism contributing to locomotor dysfunction~     post-stroke is an increased metabolic cost of walking relative to neurologically healthy~     individuals 2-4. This increased cost likely limits the amount of walking performed, which~     further reduces functional capacity, thus contributing to long-term spiral of disability and~     decreased quality of life in these persons. In addition to increased metabolic cost,~     increased estimates of mechanical work are also characteristic of hemiparetic walking 2,29.~     Interestingly, although estimates of mechanical work reflect work done by locomotor muscles,~     little is known about the impact that peripheral muscle properties have on estimates of~     mechanical work. Furthermore, questions concerning how these properties relate to the~     increased metabolic cost of walking remain unanswered. The short-term objective and purpose~     of the proposed research is to determine the extent to which peripheral muscle~     characteristics, as well as estimates of muscle mechanical energy expenditure (MMEE), relate~     to the metabolic cost of walking post-stroke.~   "
216819|NCT00721344|"~     48 healthy adult male & female subjects will be enrolled in this study to determine the~     effect of Technosphere® Inhalation Powder (FDKP) on the QT interval of the EKG. Eligible~     subjects will be randomized into a dosing regimen after admission.~   "
216820|NCT00721331|"~     This will be a phase I, single center, randomized, vehicle-controlled, blinded study~     comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1%~     mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy~     volunteers.~   "
216821|NCT00721318|"~     The chronic widespread pain (CWP) and fibromyalgia (FM) cause serious discomfort, but at the~     same time they are not life threatening and they cannot be detected by any laboratory tests.~     The problems connected with these conditions have gained little attention in Estonia so far.~     It can be assumed that the CWP and FM often remain undetected and the sufferers live without~     treatment they need.~      So far, there are no data on the prevalence of the CWP and FM in Estonia available.~      The goal of the current research is to assess the prevalence of the CWP and local pain~     syndromes among Estonia's RA patients and among the control population in Tallinn and Harju~     County; also the factors connected with the presence of the pain and the pain treatment in~     use.~      At the same time there will be a similarly designed research conducted in Jyväskylä Central~     Hospital, which provides the opportunity to compare results in Estonia's and Finland's~     research groups. The study on the distribution of the chronic pain among RA patients and~     control population will allow to assess the magnitude of the problem in Estonia and to raise~     the awareness of physicians about CWP and significance of its treatment.~      Performing the study will provide an experience which forms the base for further~     epidemiological and clinical research on CWP and FM~   "
216822|NCT00721305|"~     The purpose of this study is to determine whether the long-term administration of statins may~     benefit the clinical and immunological evolution in HIV-1-infected individuals before the use~     of antiretroviral therapy is required.~   "
216823|NCT00721279|"~     The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment~     effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International~     Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time~     to reaching maintenance dose of pramipexole~   "
216824|NCT00721266|"~     This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity~     of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid~     tumors. In the first part of the study, groups of patients will be sequentially enrolled to~     receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The~     starting dose of 50mg weekly will be escalated in subsequent groups of patients after a~     successful assessment of the safety, tolerability and pharmacokinetics of the previous dose.~     In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be~     enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part~     1. The anticipated time on study treatment is until disease progression, and the target~     sample size is <100 individuals.~   "
216825|NCT00721253|"~     This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to~     subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA~     IOL~   "
216826|NCT00721240|"~     The main aim of the study is to develop a method that allows responders to be distinguished~     from non-responders before long-term treatment is initiated. Subsidiary aims are to record~     changes in pulmonary functional parameters, NO concentrations and peak flow variability, the~     use of beta2 sympathomimetics and the asthma symptom score.~   "
216827|NCT00721227|"~     This trial will assess the feasibility of reduction gastroplasty with standard suture in~     bariatric patients who are candidates for surgical weight loss intervention.~   "
216828|NCT00721214|"~     The purpose of this study is to examine the feasibility and efficacy of using the~     demethylating agent 5-Azacytidine prior to allogeneic stem cell transplantation in patients~     with high risk myelodysplastic syndrome (MDS).~   "
216829|NCT00721201|"~     The purpose of this study is to assess the effects of reducing the activity of endogenous~     glucocorticoid in patients with low-grade cortisol excess~   "
216830|NCT00721188|"~     The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron~     Sucrose Injection) in NDD-CKD pediatric patients.~   "
216831|NCT00721175|"~     The purpose of this study is to compare the adequacy of unilateral endoscopic biliary~     drainage using metallic stent with plastic stent in unresectable, complex, hilar,~     cholangiocarcinoma and cost analysis.~   "
216832|NCT00721162|"~     The purpose of this study is to determine if ramucirumab given as monotherapy is effective in~     the treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary~     Peritoneal Carcinoma.~   "
216833|NCT00721149|"~     This trial evaluates the safety and effectiveness of catheter ablation for PAF. The~     investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.~     At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial~     distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory~     monomorphic sustained ventricular tachycardia post myocardial infarction. The catheter was~     approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.~   "
216834|NCT00721136|"~     Patients requiring long term anticoagulation often undergo transition of their warfarin to~     heparin in anticipation of invasive surgical procedures such as pacemaker or ICD~     implantation. This may require inpatient hospitalization several days prior to and after the~     procedure, potentially increasing medical costs and patient inconvenience. Patients~     undergoing such a process are initiated on heparin while their INRs drift to normal levels.~     Immediately prior to surgery, heparin is discontinued and restarted several hours after the~     procedure. Unfortunately, this process has resulted in a high incidence of surgical wound~     hematomas and other bleeding complications often requiring longer periods of discontinued~     anticoagulation or repeat surgical exploration. Previous investigators have tried to reduce~     the incidence of wound hematomas by prolonging the time from surgical wound closure to the~     reinitiation of heparin. A small randomized trial demonstrated that there was no significant~     difference in the incidence of wound hematomas whether heparin was started 6 hours or 24~     hours after surgery (J Am Coll Cardiology 2000;35:1915-8). This has led many investigators to~     perform pacemaker and ICD implantation without reversal of warfarin therapy. A recent~     retrospective observational study demonstrated that the incidence of wound hematomas in~     patients with an INR of 2.6 was no different than patients with an INR of 1.5 (PACE~     2004;27:358-60). Furthermore, a more recent, larger retrospective observational study~     reported in abstract form at the recent Heart Rhythm Society Annual 2007 Scientific Meeting~     demonstrated that not only is performing pacemaker and ICD implantations safe without~     reversing warfarin anticoagulation, but the incidence of wound hematomas is significantly~     smaller as compared to the strategy of reversing warfarin and initiating periprocedural~     heparin.~      Given these findings, the hypothesis of this randomized study is that pacemaker and ICD~     implantation while fully anticoagulated on warfarin therapy is safe. Findings from this study~     will have significant implications on the clinical practice of pacemaker or ICD implantation~     in this patient population given that no randomized study on this subject has been performed~     to date.~   "
216835|NCT00721123|"~     This open-label, international multi-center extension study WA18695 was designed to assess~     the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid~     arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in~     the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to~     treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.~   "
216836|NCT00721110|"~     This study is being done to determine if combined infusions of lidocaine and ketamine is~     better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after~     abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations~     will be done through walking tests, pain and fatigue questionnaires and blood tests.~   "
216837|NCT00721097|"~     Asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in~     developed countries. Corticosteroids are necessary to control symptoms, but induce adverse~     events sometimes intolerable. In severe asthma, which represent 5 to 10% of global asthma,~     corticosteroids frequently fail to prevent severe exacerbations, leading to emergency care,~     hospitalization and sometimes death. The aim of this study is to identify predictive factors~     specific for exacerbation outcome which will lead to a minor increase in treatment in order~     to prevent exacerbations, while minimizing drug adverse effects.~   "
216838|NCT00721084|"~     Currently, it is not known if the amount of nighttime sleep has any effect on the overall~     physical fitness, and on how much energy do people who have a relative with type 2 diabetes~     (parent, sibling, or grandparent) use to perform activities of daily living. This study will~     test the hypothesis that individual differences in nighttime sleep duration are related to~     differences in the amount of energy used to perform activities of daily living and the~     overall level of physical fitness of the individual.~   "
216839|NCT00721071|"~     The objective of the study is to evaluate the clinical utility and the feasibility, in an~     outpatient setting, of sputum induction using hypertonic saline. This study will also study~     pilot techniques on a sub using a sub-sample to assess the lower airway inflammatory cells~     and markers in relation to new emerging organisms in cystic fibrosis (CF) and antibiotic~     therapy in CF.~   "
216840|NCT00721058|"~     Rationale: Whole breast irradiation with 50 Gy after lumpectomy has been shown to reduce the~     local recurrence rate with a factor 3 to 4. An additional boost of 16 Gy to the tumorbed has~     been shown to improve the local control rate even further. However, this boost dose appears~     to reduce not only the local recurrences in the tumorbed, but also elsewhere in the breast,~     suggesting that the boost may not always be delivered at the correct region. In addition,~     even with the boost dose of 16 Gy, the local recurrence rate in young patients is still quite~     high - with the majority of recurrences in the tumorbed. Consequently, further improvement of~     the local control, especially in young women, is still an important aim to pursue, in order~     to maintain breast conserving therapy (BCT) as an acceptable treatment option in young women.~     One way to improve local control may be to increase the dose [Young Boost Trial], but also to~     improve the definition of the tumorbed, i.e. the target volume for boost irradiation.~      Objective: The aim of this study is to investigate the effect of incorporating a~     contrast-enhanced (CE)-CT-thorax in the target volume delineation process on 1) the coverage~     of the tumorbed by the 85% isodose, 2) the size of the irradiated boost volumes, and 3) the~     interobserver variation in target volume delineation.~      Study design: A CE-CT scan of the thorax will be made prior to surgery, with the patient in~     radiation treatment position. After breast conserving surgery, patients will be referred for~     post-operative radiotherapy according to the standard guidelines. Prior to radiotherapy, a~     standard CT thorax scan will be made for treatment planning.~      The planning target volume (PTV) for the boost will be delineated according to the MAASTRO~     protocol, by three independent observers (PTV-1A-C), using the planning CT only. Delineation~     of the boost will be repeated after 3D registration of the pre-operative CT scan with the~     planning CT-scan (PTV-2A-C). Thereafter, consensus will be obtained for the PTV-1A-C and the~     PTV-2A-C, resulting in one PTV-1 and one PTV-2 for each patient. Radiation treatment plans~     (RT-plans) will subsequently be designed for PTV-1 and PTV-2. Coverage of the treatment plans~     by the 85% isodose for both PTV-1- and PTV-2, and the irradiated volumes (percentage of the~     volume receiving 95% or more (V95)) will be calculated. Patients will be treated with the~     treatment plan for PTV-2.~      Study population: 60 breast cancer patients, to be treated with BCT, with a mass visible on~     mammography and/or ultrasound > 0.5 cm, without contraindications for a CE-CT-thorax scan~     will be included.~      Intervention: < 3 weeks prior to lumpectomy a CE-CT-thorax scan will be made of the entire~     thorax, with the patient in the same position as planned during the post-operative~     radiotherapy. Intravenous contrast will be given according to the standard thorax protocol of~     MAASTRO clinic.~      Main study parameters/endpoints:~      Primary endpoints are:~        1. The percentage of the PTV-2 receiving < 85% of the dose, if treated with the RT-plan for~          PTV-1.~        2. Difference in V95 for the RT-plan designed for PTV-1- versus for PTV-2. Other endpoints~          will be interobserver variation, as measured by 1) percent volume overlap; 2) difference~          in standard deviation of the average PTV-1 and PTV-2; 3) center of mass assay.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Patients will only be included after written informed consent. The preoperative~     CE-CT-thorax-scan yields little additional radiation exposure, which will however be~     negligible compared to the radiation treatment to be given because of the breast cancer. In~     addition, there is a small risk on an allergic reaction to the intravenous contrast, and on~     renal complications. Therefore, renal function will be checked prior to giving contrast. A~     kreatinine clearance < 60 ml/min will be a contra-indication for contrast. The pre-operative~     CT-scan will be made in MAASTRO clinic, requiring an additional visit to MAASTRO clinic. A~     possible benefit may be that the pre-operative CE-CT thorax may improve the definition of the~     target volume, and thereby reduce the risk on a local recurrence.~   "
216841|NCT00721045|"~     This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability~     of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in~     subjects who have cardiomyopathy of both ischemic and idiopathic etiology.~   "
216842|NCT00721032|"~     Ventricular tachycardia (VT) is a morbid arrhythmia responsible for many sudden deaths and~     ICD shocks. Despite much progress in the treatment of arrhythmia, VT remains a therapeutic~     challenge. Most patients with VT have an implantable cardioverter defibrillator (ICD) for~     secondary prevention of sudden cardiac death, however, an ICD merely treats VT, it does not~     prevent VT. In patients with recurrent VT and ICD shocks, two strategies are available to~     decrease the burden of VT. The first is antiarrhythmic drugs, and the second is VT ablation.~     The aim of this study is to compare the efficacy of antiarrhythmic drugs and VT ablation~     guided by MRI. VT can sometimes be suppressed with antiarrhythmic medications, however, these~     are often ineffective, and carry a high burden of side effects. Many forms of VT can be cured~     by selective destruction of critical electrical pathways with catheter ablation. A major~     limitation in the ablation of VT, however, is the time required to localize scar tissue and~     important pathways for targeting of lesions. Magnetic resonance imaging can now obtain~     reliable images of scar location within the ventricles. Recent advances in electroanatomical~     mapping systems allow operators to import pre-acquired images into the mapping system. The~     aim of this study is to examine the feasibility of importing historic MRI scar maps of the~     ventricles into the electroanatomical system and using such images to guide catheter~     ablation, as compared to antiarrhythmic drug suppression of VT. We suspect that MRI guidance~     will be especially useful in patients with unstable VT, i.e. VT that causes an abrupt drop~     in blood pressure, and thus cannot be maintained in the electrophysiology (EP) lab for~     mapping and entertainment purposes. Patients referred for VT ablation have ICDs. Through~     previously completed animal work (Circulation 2004; 110(5): 475-82) and a human trial (2006~     Sep 19;114(12):1277-84) we have demonstrated the safety of MRI in the setting of pacemakers~     and implantable defibrillators using appropriate precautions. Through careful device~     programming and using MRI sequences with limited energy exposure (specific absorption rate <~     2 W/kg) we will study the pre procedural myocardial anatomy of patients enrolled into this~     study.~      The primary endpoint will be lack of VT documented by implantable defibrillator (when~     present) interrogation or Holter monitoring 6 months post ablation. The secondary endpoints~     will be comparison of inducible arrhythmia at the end of the procedure, procedure time,~     comparison of endocardial voltage mapping to scar on delayed enhancement MRI images, and~     complications in each study arm.~   "
216843|NCT00721019|"~     The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when~     people sleep. However, it is still not known if differences in the amount of nighttime sleep~     have an effect on the carbohydrate metabolism of people who have a relative with type 2~     diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis~     that the carbohydrate metabolism of people who have a history of type 2 diabetes in their~     family will be different after they have slept short hours for 10 days in comparison to when~     they have slept longer hours for 10 days.~   "
216903|NCT00720200|"~     The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on~     communication with family members of patients who are too sick to make decisions about their~     own care while they are in the ICU. The randomized trial will test the efficacy of a~     communication intervention designed to improve communication between families and clinicians~     through the use of a facilitator. Outcome evaluation occurs at the level of the individual~     family with surveys completed by families and clinicians.~   "
217088|NCT00717743|"~     To define the frequency of T regulatory cells in peripheral blood of RCC patients before and~     after nephrectomy.~      Study hypothesis: That nephrectomy results in a normalisation of peripheral blood T regs in~     early stage RCC, and a lowering of T regs in advanced RCC.~   "
216844|NCT00721006|"~     The purpose of this research study is to compare in patients with double-sided claudication~     if the transplant of a combination of stem cells obtained from the bone marrow of the same~     patient will contribute to the formation of new blood vessels in one of the severly diseased~     ischemic limbs(legs)versus the control limb that receives a placebo product.~      Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood~     flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain~     and even skin ulcers or sores.~      LI needs comprehensive treatment since the condition will not improve on its own. The overall~     goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the~     leg and feet. In many cases, current options for treatment including medications, surgery or~     endovascular procedures have not been successful.~      In the last few years, investigators have explored therapies aimed to increase blood flow to~     the ischemic vessel by transplanting cells that will promote the development of new vessels~     in the diseased leg.~      The study hypothesis is based on the concept that the process of formation of new blood~     vessels is complex and requires the participation of several types of stem cells and growth~     factors. The lack of any of these components will produce vessels which are immature and~     unable to provide appropriated blood supply to the leg.~      Patients eligible to participate in the this study are those suffering from double-sided~     claudication with poor circulation or severe leg blockages, which are not candidates for~     surgical procedures.~      Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will~     be transplanted into the calf muscle of one the the diseased legs while the other diseased~     leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem~     cell transplant will be performed for six months post cell transplant.~   "
216845|NCT00720993|"~     The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal~     cells collected through the use of a standard anoscope and cytology brush. Patients will~     include those scheduled for routine colonoscopy procedures and those with confirmed~     colorectal cancer.~   "
216846|NCT00720980|"~     Granuloma annulare is a benign, usually self-limiting, cutaneous dermatosis, which typically~     presents as asymptomatic, flesh-colored or red papules, frequently arranged in an annular~     pattern on the distal extremities. Although localized granuloma annulare is most commonly~     observed, a generalized or disseminated form can occur. The etiology of granuloma annulare is~     unknown, however, multiple inciting factors have been proposed. The purpose of the~     investigators is to review the outcomes of treatment of granuloma annulare (GA) resistant to~     standard regimens that resolved after a 3-months treatment course of monthly rifampin,~     ofloxacin, and minocycline (ROM) therapy, successfully used to treat paucibacillary leprosy,~     a disease with clinical and histopathologic similarity to GA.~   "
216847|NCT00720967|"~     The purpose of this study is to determine whether preoperative hemodialysis or intraoperative~     modified ultrafiltration are effective for patients with non-dialysis dependent severe renal~     dysfunction undergoing open heart surgery.~   "
216848|NCT00720954|"~     The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle~     biopsy by the diagnostic efficacy and safety in patients with pleural effusion.~   "
216849|NCT00720941|"~     This study is being conducted to provide a direct comparison of the efficacy, safety and~     tolerability for pazopanib and sunitinib (SUTENT)~   "
216850|NCT00720928|"~     Objectives:~      To describe the safety and efficacy of intravitreal flucinolone acetonide implants in the~     management of patients having refractory ocular Behcet's disease~      Hypothesis:~      A descriptive observational study~      Study design:~      A 1-year, multi-center (including four Korean medical centers) observational study~   "
216851|NCT00720915|"~     The purpose of this study is to determine if the risk of recurrent venous thromboembolism~     (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked~     proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of~     therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.~   "
216852|NCT00720902|"~     This protocol will assess the cardiovascular risk associated with growth hormone deficiency~     in adults. We will use multiple modalities to assess risk for heart attacks or strokes~     including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are~     growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize~     that adults with growth hormone deficiency will have results suggestive of an increased risk~     for cardiovascular disease.~   "
216853|NCT00720889|"~     The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when~     people sleep. However, it is still not known if differences in the amount of nighttime sleep~     have an effect on the carbohydrate metabolism of people who have a relative with type 2~     diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis~     that individual differences in habitual sleep duration may be related to differences in the~     carbohydrate metabolism of people who have a history of type 2 diabetes in their family.~   "
216854|NCT00720876|"~     RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Giving vorinostat~     together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects of giving vorinostat together with~     rituximab and to see how well it works in treating patients with indolent non-Hodgkin~     lymphoma.~   "
216855|NCT00720850|"~     The hypothesis of this study is that lenalidomide can be an effective drug in preventing~     relapse of MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q~     after allogeneic HSCT. Due to its immunomodulatory action it might also be able to enhance a~     T - or NK cell mediated graft versus leukemia (GVL) effects. Nevertheless, one has to keep in~     mind a possible, yet unknown influence on modulation of clinical GVHD.~   "
216856|NCT00720837|"~     The goal of this clinical research study is to learn about a new therapy device called the~     Visualase® Thermal Therapy System (a device that uses a laser to kill tumor cells and is~     guided using magnetic resonance thermal imaging [MRTI]). The Visualase® Thermal Therapy~     System is used to treat metastatic brain tumors. Researchers want to find out if it is~     possible to use this new device in patients with metastatic brain tumor(s), each measuring 3~     centimeters (cm) or smaller. The safety of the device will also be studied.~   "
216857|NCT00720824|"~     A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic~     suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged~     children.~   "
216941|NCT00719680|"~     The purpose of this study is to determine whether a long-term use of a new human~     immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary~     immunodeficiency.~   "
217137|NCT00717106|"~     The purpose of this study is to obtain information on real-world device performance clinical~     assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring~     System.~   "
216858|NCT00720811|"~     This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The~     primary activity of the study wil be a two armed cluster randomised trial in two study sites~     in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic~     and the other meso-endemic for malaria. In one arm the children will be treated presumptively~     for malaria with ACT (control arm) and the other arm the children will receive ACT only when~     they have a positive RDT result (implementation arm). The children in the implementation arm~     will also receive antibiotics if they have a raised respiratory rate. The primary outcome~     will be the recovery rate in the intervention arm compared to that of the control arm on Day~     3. In addition, an acceptability assessment of RDTs in the community will be undertaken both~     before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy~     will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to~     demonstrate comparable levels of endemicity in control and intervention groups. These~     activities will be carried out over a two year period.~   "
216859|NCT00720798|"~     This single-arm study evaluated the long-term efficacy and safety of tocilizumab in~     participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche~     protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol~     WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in~     combination with standard anti-rheumatic treatment.~   "
216860|NCT00720785|"~     Natural killer (NK) cells are white blood cells that have a limited ability to kill cancer~     cells. This ability might be enhanced if they are given 24 hours after an injection of the~     drug bortezomib. This study will determine the following:~        -  What dose of NK cells can be given safely to subjects with metastatic solid tumors or~          leukemia.~        -  The effectiveness and side effects of NK cell therapy~        -  How the body handles NK cells.~      People between 18 and 70 years of age who have a solid tumor or leukemia, and for whom~     standard treatments are not effective, may be eligible for this study. Participants undergo~     the following procedures:~      Apheresis to collect NK cells. For this procedure, a catheter (plastic tube) is placed in a~     vein in the subject s arm. Blood flows from the vein into a cell separator machine, which~     separates the white cells from the other blood components. The white cells are extracted and~     the rest of the blood is returned to the body through a second tube placed in a vein in the~     other arm.~      Chemotherapy with the drug pentostatin to suppress the immune system and prevent it from~     attacking the NK cells that will be infused.~      Chemotherapy with bortezomib to increase NK cell function.~      Infusion of the NK cells. In this dose-escalating study, successive groups of patients~     entering the study receive increasingly higher numbers of cells to determine the highest safe~     dose level. Up to ten dose levels may be studied.~      Interleukin-2 drug therapy to maintain NK cell activity.~      Evaluations during therapy including:~        -  Clinical assessment, history and review of medications~        -  Blood draws for routine and research tests.~        -  Pharmacokinetics study after the NK infusion to see how the body handles the cells. For~          this test, the number of NK cells in the blood are measured over time. This requires~          drawing about 1 teaspoon of blood at 15 minutes, 30 minutes, 1, 2, 4, 8, 12, and 24~          hours after the infusion (day 1); then every 24 hours on days 2 through 7, then once on~          days 10, 14, and 21.~        -  Bone marrow biopsy (subjects with leukemia only).~        -  Chest x-ray.~        -  CT scan, bone scan and PET scan, if indicated, for disease evaluation.~      Subjects who respond well after one treatment cycle may be eligible to continue NK cell~     therapy.~   "
216861|NCT00720772|"~     The present study will examine the treatment effect of sodium thiosulfate on coronary~     calcification in patients on hemodialysis.~   "
216862|NCT00720759|"~     Each year 730,000 Americans experience a stroke. Forty percent are left with significant~     paralysis of one arm. Certain types of physical therapy, for example constraint induced~     movement therapy (CIMT), have been shown to be effective in improving arm function. However,~     for most subjects, improvement is modest. In this trial, we test two approaches that may~     increase the amount of improvement achieved: 1) distributing treatment over a greater amount~     of time; and 2) adding a drug, d-cycloserine, which theoretically enhances the molecular~     mechanisms of learning.~   "
216863|NCT00720733|"~     An intervention designed to increase positive affect in a population newly diagnosed with HIV~     will be effective at improving affect and HIV-related outcomes such as mental and physical~     health, coping and coping resources.~   "
216864|NCT00720720|"~     The objective of this exploratory study is to analyse in humans any qualitative changes of~     carotid artery atherosclerotic plaque under the influence of plant sterols consumption.~   "
216865|NCT00720707|"~     The aim of this study is to compare the clinical outcomes of root coverage procedures, using~     coronally advanced flap in combination with acellular dermal matrix with or without enamel~     matrix derivatives .~   "
216866|NCT00720694|"~     The purpose of this study is to determine if the Storz Duolith SD1 is more effective than~     placebo for treatment of heel pain syndrome for patients who have failed conservative~     treatment with other therapies.~   "
216867|NCT00720681|"~     The purpose of this study is to review our experience with the operative management of acute~     diaphyseal fractures of the humerus via an anterolateral approach with the use of small~     fragment fixation at a Level I, urban, trauma center. We will report our clinical and~     radiographic results, complication rate and final range of motion. A standardized outcome~     measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be~     evaluated by a standard protocol, accomplished with the assistance of a licensed physical~     therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal~     fractures via an antero-lateral approach with the use of small fragment fixation is a safe~     and efficacious way to treat multiple trauma patients with these injuries.~   "
216868|NCT00720668|"~     This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous~     radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.~   "
216869|NCT00720655|"~     The aim of the study is to examine the effects of fatty fish and white (lean) fish on~     cardiovascular disease risk factor levels in subjects with established coronary heart disease~     using multiple medications. The main end points are blood pressure, serum lipids,~     inflammatory markers, arrhythmias and gene expression in peripheral mononuclear cells. The~     study design was a controlled, parallel study lasting 8 weeks with three diet groups: fatty~     fish, white fish and control group (lean pork, beef or chicken).~   "
216870|NCT00720642|"~     To confirm that a definitive diagnosis can be made from the tissue sample collected using the~     Intact BLES when defined radiology and pathology criteria are met.~   "
216871|NCT00720629|"~     The purpose of this study was to test whether a new drug named visilizumab would decrease the~     severity of graft-versus-host disease in patients treated with a mismatched donor.~     Investigators planned to use visilizumab in combination with tacrolimus and methotrexate as~     the study treatment.~   "
216986|NCT00719095|"~     There has been an alarming increase in abuse of prescription opioids in recent years. This~     project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse~     that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine~     detoxification and naltrexone maintenance.~   "
216872|NCT00720616|"~     Study hypothesis:~      Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like~     growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects~     with metabolic syndrome.~      Study aims:~      The purpose of this study is to determine the mechanism of how low dose GH treatment affects~     the body's sensitivity to insulin actions and whether this low GH dose can affect the body's~     handling of steroid hormone levels (cortisol clearance) and fat deposition in subjects with~     metabolic syndrome.~      Study design: Subjects that satisfy the criteria of metabolic syndrome (central obesity,~     treated or untreated high blood pressure, high cholesterol and impaired fasting glucose~     levels) will be invited to participate in this study. The subjects will be assessed at the~     initial visit to ascertain their suitability before further participation in the study. If~     eligible, an equal number of men and women will be randomized (like a flip of a coin) to~     receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging~     over for another 12 weeks of treatment after a 4-week washout period. Before, during and~     after treatment, the subjects will be assessed at frequently with blood tests, scans and fat~     biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and~     Translational Research Institute (OCTRI). At the first, second and final visit, testing will~     include scans to measure the amount of whole body fat and fat in the stomach area, muscle,~     and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy)~     analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by~     growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in~     the body (insulin sensitivity) will be collected at all visits of the study.~   "
216873|NCT00720603|"~     The purpose of this program is to provide expanded access to plerixafor for patients with~     NHL, HD, or MM who are to receive treatment with an autologous peripheral stem cell~     transplant.~   "
216874|NCT00720590|"~     HIV protease inhibitors (PIs) are a class of antiretroviral drugs used to inhibit viral~     replication. They do so by interfering with a key step in the replication process. Some HIV~     PIs have been associated with an increased risk of adverse cardiovascular side effects.~     Further study is needed, however, to assess the full extent of effect of newer HIV PIs,~     including atazanavir and lopinavir/ritonavir, on cardiovascular disease risk. This study will~     compare the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular~     disease risk factors in healthy people without HIV.~   "
216875|NCT00720577|"~     Part A. The purpose of this study is to assess the effects of 6 weeks of treatment with,~     simvastatin, losartan or pioglitazone compared to placebo on the RNA expression profile of~     lower extremity peripheral arterial atherosclerotic plaque. Part B. The effect of~     simvastatin, losartan or pioglitazone compared to placebo on protein and lipid biomarkers in~     lower extremity peripheral arterial atherosclerotic plaque.~   "
216876|NCT00720564|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as arsenic trioxide and temozolomide, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic~     trioxide and temozolomide may also make tumor cells more sensitive to radiation therapy.~     Giving radiation therapy together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide~     when given together with temozolomide and radiation therapy in treating patients with newly~     diagnosed high-grade glioma.~   "
216877|NCT00720551|"~     The aim of this study is to calibrate the STISIM driving simulator under influence of three~     different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance~     decrement for the three blood alcohol concentrations will serve as a standard for comparing~     the effects that will be observed with psychoactive drugs in future trials. This will make~     the results of these future studies more easily to interpret and will provide health care~     providers and policy makers who read our scientific work with an easy-to-understand and~     clinically relevant comparison.~   "
216878|NCT00720538|"~     Several open-label studies reported thalidomide efficacy in inducing clinical remission and~     steroid tapering in refractory Inflammatory Bowel diseases (IBD), both in adults and in~     children.~      This is a randomized placebo controlled (RCT) double blind study, to evaluate the efficacy of~     thalidomide in inducing clinical remission at 8 weeks in refractory IBD patients aged 2-20~     years.~      The primary hypotheses of the study is that thalidomide would be more effective than placebo~     in inducing clinical remission.~      The RCT phase is followed by a open-label phase, to further evaluate efficacy and safety of~     thalidomide in thalidomide responders, with a total follow up of one year.~   "
216879|NCT00720525|"~     Over the past few years, there has been a growing appreciation that a large number of~     patients with heart failure have a relatively normal (or preserved) ejection fraction~     (NFNEF). Epidemiologically, HFNEF is most prevalent among elderly women, most of whom have~     hypertension, diabetes, or both and often coronary artery disease (CAD). Increased arterial~     stiffness and/or wave reflections have been described in the same patient groups. Therefore,~     the investigators speculate that pulsatile hemodynamics, representing arterial stiffness~     and/or arterial wave reflections, 1) may be altered in HFNEF patients, 2) this may contribute~     to pathophysiology of HFNEF, and 3) this may be used for the diagnosis of the syndrome.~   "
216880|NCT00720512|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     It is not yet known whether combination chemotherapy is more effective with or without~     bevacizumab in treating metastatic colorectal cancer.~      PURPOSE: This randomized phase III trial is studying second-line combination chemotherapy to~     see how well it works compared with or without bevacizumab in treating patients with~     metastatic colorectal cancer who have received first-line chemotherapy and bevacizumab.~   "
216881|NCT00720499|"~     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL~     administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the~     Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary~     disease (COPD).~   "
216882|NCT00720486|"~     This study will evaluate the effectiveness of an anger management treatment program, Juvenile~     Justice Anger Management for Girls, in reducing anger-related behaviors displayed by girls in~     the juvenile justice system.~   "
216883|NCT00720473|"~     We propose to study the efficacy and tolerability of lamotrigine in the treatment of older~     adults with bipolar depression and to compare measures of brain energy metabolism between~     older subjects with bipolar depression and healthy age-matched controls in order to better~     understand treatment response in geriatric bipolar depression.~   "
217138|NCT00717093|"~     The primary goal of this study is to compare efficacy of varenicline to placebo for cessation~     of use of smokeless tobacco.~   "
216884|NCT00720460|"~     This study will test new techniques to image the heart, blood vessels, and legs using~     magnetic resonance imaging (MRI). The techniques will be used to plan and guide treatments~     using minimally invasive methods.~      Healthy normal volunteers 18 years of age and older may be eligible for this study.~      For MRI, the subject lies flat on a table that can slide in and out of the scanner, a metal~     cyclinder. Special antennas, covered in pads, are placed against the subject s body. The scan~     time can vary from 20 minutes to 2 hours, with most scans lasting between 45 and 90 minutes.~     The subject may be asked to wear adhesive patches on the chest for monitoring the heart and a~     belt or finger pad for monitoring breathing. During the test, a contrast agent called~     gadolinium may be injected. This substance brightens the heart and arteries during the scan,~     providing a better picture of blood flow.~      During the procedure, subjects may be asked to exercise their legs on a machine to evaluate~     the effects of motion and exercise on the MRI exam.~      Large blood pressures cuffs may be placed on either or both thighs or calves to try to~     measure arterial flow to the legs. The cuffs are inflated to a pressure as high as at least~     50 mmHg higher than thesubject s systolic blood pressure (up to 250 mmHg) for up to 10~     minutes.~      Subjects may be asked to return for repeated scans.~   "
216885|NCT00720447|"~     RATIONALE: Giving chemotherapy and monoclonal antibody therapy before a donor stem cell~     transplant helps stop the growth of cancer cells. It also helps stop the patient's immune~     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are~     infused into the patient they may help the patient's bone marrow make stem cells, red blood~     cells, white blood cells, and platelets.~      PURPOSE: This phase II trial is studying donor stem cell transplant in treating patients with~     mantle cell lymphoma.~   "
216886|NCT00720434|"~     The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase~     inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of~     PF-00868554 in combination with current standard of care therapy, pegylated~     interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).~   "
216887|NCT00720421|"~     The purpose of the study is to determine the effects of the compound AZD7325 as compared to~     lorazepam on sleepiness, concentration and brain activity.~   "
216888|NCT00720408|"~     The purpose of this study is to compare the efficacy and safety of Prograf extended~     release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant~     recipients~   "
216889|NCT00720395|"~     This study will evaluate pregnant women who have bipolar disorder to gain a better~     understanding of risk factors for bipolar disorder relapse during pregnancy and the~     postpartum period.~   "
216890|NCT00720382|"~     The purpose of this study is to determine if one allergy treatment (0.15% azelastine~     hydrochloride) is as safe as mometasone furoate (nasonex) alone.~   "
216891|NCT00720369|"~     We propose to study and compare measures of brain energy metabolism in geriatric bipolar~     individuals and healthy older adults. We would also like to investigate changes in brain~     energy metabolites and in vivo creatine kinase (CK) enzymatic activity associated with CoQ10~     administration in older bipolar individuals.~   "
216892|NCT00720356|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab~     together with erlotinib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib~     works after radiation therapy and temozolomide in treating patients with newly diagnosed~     glioblastoma multiforme or gliosarcoma.~   "
216893|NCT00720343|"~     This research will test whether consuming additional choline before gynecological surgery~     decreases postoperative pain.~   "
216894|NCT00720330|"~     The investigators are conducting this study to find out if intravenous (injected through the~     vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective~     as a paravertebral block in lessening pain after surgery and that both of these techniques~     are superior to general anesthesia alone in reducing pain immediately after surgery and in~     the long-term.~   "
216895|NCT00720317|"~     To more clearly ascertain the relationship between ocular manifestations of sickle cell~     disease and diabetes, specifically; whether the presence of sickle cell trait exacerbates the~     disease progression of diabetic retinopathy.~   "
216896|NCT00720304|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib~     together with docetaxel and radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well erlotinib given together with docetaxel and~     radiation therapy works in treating patients with stage III or stage IV squamous cell~     carcinoma of the head and neck.~   "
216897|NCT00720291|"~     Most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm~     birth. Despite this, there is no evidence that screening and treatment of asymptomatic~     bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent~     rate of preterm birth. However, treatment of symptomatic bacterial vaginosis has been~     associated with a modest reduction in subsequent preterm birth. Potential mechanisms for this~     reduction include a decrease in peripheral maternal pro-inflammatory activation of the TH1~     inflammatory cascade with treatment, however this direct pathway has not been elucidated. The~     approved treatment for bacterial vaginosis during pregnancy consists of Metronidazole 500mg~     BID for 7 days. A more complete understanding of the effect of Metronidazole on maternal~     inflammation would be useful in designing strategies to reduce the rates of preterm birth.~      This study proposes to determine the effect of standard treatment of BV carriage on maternal~     serum markers of inflammation. This will be accomplished by giving patients with asymptomatic~     BV either the standard treatment of metronidazole or a placebo for 7 days. Blood will be~     drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha.~   "
216898|NCT00720278|"~     The purpose of this study was to determine if two allergy medications are more effective than~     placebo.~   "
216904|NCT00720174|"~     This phase I trial is studying the side effects and best dose of cixutumumab given together~     with doxorubicin hydrochloride and to see how well they work in treating patients with~     unresectable, locally advanced, or metastatic soft tissue sarcoma. Monoclonal antibodies,~     such as cixutumumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Drugs used in chemotherapy, such as doxorubicin~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving monoclonal antibody cixutumumab together~     with doxorubicin hydrochloride may kill more tumor cells.~   "
216905|NCT00720161|"~     Obesity with insulin resistance in the paediatric population provides an increasing~     challenge. Children with neurological or neuromuscular diseases are even more prone to~     obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease~     in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated~     with a decrease in physical fitness and a further increase in body fat. In this study we want~     to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese~     patients with neurological or neuromuscular diseases. Metformin is a well-established insulin~     sensitizer.~   "
216906|NCT00720148|"~     The purpose of this study is to test the effect of the combination of sunitinib and~     bortezomib. We will see what effects it has on your cancer and find the highest dose of each~     agent that can be given without causing severe side effects.~   "
216907|NCT00720135|"~     RATIONALE: Biological therapies, such as fusion protein cytokine therapy, may stimulate the~     immune system in different ways and stop cancer cells from growing. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Giving fusion protein cytokine therapy together with~     rituximab may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of fusion protein~     cytokine therapy when given after rituximab in treating patients with B-cell non-Hodgkin~     lymphoma.~   "
216908|NCT00720122|"~     Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral~     density at a time when healthy adolescents are rapidly accruing bone, with implications for~     peak bone mass and fracture risk in later life. They are also deficient in insulin-like~     growth factor 1 (IGF-1), the bone trophic factor made in the liver in response to growth~     hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of~     insulin-like growth factor 1, a hormone very important for the maintenance of skeletal~     integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic~     effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents~     and young adults with anorexia nervosa have not been studied. The goal of this proposal is to~     investigate the effects of recombinant human insulin-like growth factor 1 on bone density and~     bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a~     6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients,~     being insulin-like growth factor 1 deficient, will respond to exogenously administered~     recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone~     turnover and an increase in bone density and improvement in bone structure, or maintain bone~     density (in contrast to the decrease in bone density expected in adolescent girls and women~     with anorexia nervosa who are not treated).~   "
216909|NCT00720109|"~     This phase II/III trial is studying the side effects and how well giving dasatinib together~     with combination chemotherapy works in treating young patients with newly diagnosed acute~     lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.~   "
216910|NCT00720096|"~     This pilot study will help us to determine the success of using a special technique called~     microarray technology to examine cancer genes in order to predict how individual women will~     respond to one of two therapies, liposomal doxorubicin or topotecan, and which will be more~     effective in treating ovarian cancer that has returned (recurrent ovarian cancer). We believe~     that this study may lead to a means by which microarray technology can predict the most~     effective treatment decision, based on the genetic characteristics of her tumor tissue, for a~     woman with recurrent ovarian cancer.~      Another purpose of this study is to determine how quickly a woman with recurrent ovarian~     cancer will respond to treatment (treatment response rate) and to evaluate the accuracy of~     the genomic predictions.~      Recent data suggest that microarray technology can predict a patient's response to~     chemotherapy; this has not yet been proven in a forward-looking study which is why we are~     conducting this research.~   "
216911|NCT00720083|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Vandetanib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether giving chemotherapy together with radiation therapy is more effective with or without~     vandetanib in treating patients with head and neck cancer.~      PURPOSE: This randomized phase II trial is studying giving chemotherapy together with~     radiation therapy to see how well it works compared with giving chemotherapy and radiation~     therapy together with vandetanib in treating patients with high-risk stage III or stage IV~     head and neck cancer.~   "
216912|NCT00720070|"~     RATIONALE: Imaging procedures, such as PET/CT scan, produce pictures of areas inside the body~     and may help doctors detect residual disease and plan the best treatment. Neck dissection is~     surgery to remove lymph nodes and other tissues in the neck. It is not yet known whether a~     neck dissection should always be performed in treating patients with head and neck cancer.~      PURPOSE: This randomized phase III trial is studying PET/CT scan-guided watchful waiting~     compared with neck dissection of locally advanced lymph node metastases in treating patients~     who are undergoing chemotherapy and radiation therapy for primary head and neck cancer.~   "
216913|NCT00720057|"~     To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium~     extended-release tablet, compared to placebo in postsurgical dental pain.~   "
216914|NCT00720031|"~     Most of HLA-A2 melanomas express Melan-A/MART-1 antigen and are recognized by tumor reactive~     Melan-A specific T lymphocytes. By using blood samples from HLA-A2 melanoma patients (stage~     III and IV), our goal is to produce a tumor reactive Melan-A specific T cell clones and to~     conduct a phase I-II clinical trial, based on the infusion of several millions to several~     billions of these lymphocytes to the patient, in order to induce passive immunity against~     this antigen. Production of the clones will be performed in the Unit for Cellular and Gene~     Therapy from Nantes University Hospital. Therapeutic response, safety treatment but also~     localization and survival of infused T cell clones will be assessed. This approach is~     expected to precise the ability of the clones to migrate within the tumor and to transfer~     specific immunity.~   "
216915|NCT00720018|"~     The primary objective is to compare the pharmacokinetics (PK) profiles among five NP101~     patches in healthy volunteers.~      The secondary objective is to evaluate the safety of NP101 in healthy volunteers.~   "
216916|NCT00720005|"~     The purpose of this study is to evaluate the visual outcomes and patient satisfaction after~     bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare~     it to a historical control group of patients implanted bilaterally with the spherical ReSTOR~     multifocal~   "
216917|NCT00719992|"~     The aim of this study was to assess the amount of additive value of HS-CRP levels to a~     positive exercise tolerance test (ETT) in predicting coronary artery disease (CAD) using~     coronary angiography as the gold standard. The investigators concluded that HS-CRP can be~     used as a single predictor of coronary vessel involvement in patients with stable angina and~     positive ETT.~   "
216918|NCT00719979|"~     This study will develop and evaluate the effectiveness of a technology-assisted behavioral~     intervention, consisting of Internet-based cognitive behavioral therapy combined with~     telephone and email support, in reducing depressive symptoms and improving treatment~     adherence in primary care patients with major depressive disorder.~   "
216919|NCT00719966|"~     RATIONALE: Aromatase inhibitor therapy is used in treating postmenopausal women who have~     hormone-dependent breast cancer. It is not yet known what effect aromatase inhibitor therapy~     has on blood vessel function.~      PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood~     vessel function in postmenopausal women with breast cancer.~   "
216920|NCT00719953|"~     A Single-Center, Open Label Study to Assess the Efficacy of Cognitex in Elderly Subjects with~     Memory Impairment~   "
216921|NCT00719940|"~     Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral~     therapy intervention procedures that are manualized and structured within the disease~     management program TCP are effective.~   "
216922|NCT00719927|"~     Latinas are more likely to be obese and physically inactive than white women. Therefore, a~     behavioral weight loss program for Latinas will be tested in this pilot study. Thirty~     overweight or obese Latinas will be recruited for a 12 week weight loss program at the Weight~     Control & Diabetes Research Center. Participants will be provided with nutrition and physical~     activity education and be taught behavioral skills to help them adopt lifestyle changes that~     produce weight loss. Participants will be placed on a reduced calorie diet and instructed to~     gradually increase their level of physical activity. To encourage participants to monitor~     their daily eating and exercise activities, participants will be instructed to record these~     activities in food and exercise diaries and submit them each week. Two treatment groups will~     be tested. The first group will have participants attend sessions with a female friend~     (comadre). The second group will have participants attend sessions without a comadre. The~     aims of this study are to determine whether we can succeed in recruiting Latinas with their~     comadres and whether we can reduce participant drop-out by having Latinas participate with~     their comadres in a behavioral weight loss program.~   "
216923|NCT00719914|"~     The main purpose of this research study is to try to improve the results of the standard~     treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose~     of eptifibatide in the emergency room, shortly after arriving. This drug is usually given~     through a vein in the arm. However, eptifibatide can also be injected directly into the~     heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in~     the heart. This new way of giving the drug is being studying.~   "
216924|NCT00719901|"~     This phase I/II trial is studying the side effects and best dose of obatoclax when given~     together with bortezomib and to see how well they work in treating patients with relapsed or~     refractory multiple myeloma. Obatoclax and bortezomib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Giving obatoclax together with~     bortezomib may kill more cancer cells.~   "
216925|NCT00719888|"~     This phase II trial studies how well giving an umbilical cord blood transplant together with~     cyclophosphamide, fludarabine phosphate, and total-body irradiation (TBI) works in treating~     patients with hematologic disease. Giving chemotherapy, such as cyclophosphamide and~     fludarabine phosphate, and TBI before a donor umbilical cord blood transplant helps stop the~     growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting~     the donor's stem cells. When the healthy stem cells from a donor are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets. Sometimes the transplanted cells from a donor can make an immune response~     against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after~     transplant may stop this from happening.~   "
216926|NCT00719875|"~     The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics~     (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given~     on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST~     criteria.~      This study was originally intended to be a phase 1/phase 2. The protocol was amended to make~     this study a phase 1 only.~   "
216927|NCT00719862|"~     The Purpose of this study is to determine if one allergy medication (0.15% azelastine~     hydrochloride) is more effective than Placebo alone~   "
216942|NCT00719667|"~     Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of~     the best treatment concept for patients older or 75 years old.~      Hypothesis: The coronary bypass operation without use of the heart-lung machine~     (off-pump=OPCAB) reduces the combined endpoint in comparison with the conventional coronary~     bypass operation (on-pump).~   "
216928|NCT00719849|"~     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor~     umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It may~     also stop the patient's immune system from rejecting the donor's stem cells. The donated stem~     cells may replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving cyclosporine and mycophenolate~     mofetil before and after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well donor umbilical cord blood transplant with~     reduced intensity conditioning works in treating patients with advanced hematological cancer~     or other disease.~   "
216929|NCT00719836|"~     This study consists of two phases: the first portion of the study is a Phase 1 dose~     escalation study to determine the maximum tolerated dose and the dose limiting toxicities of~     SB1518 when given as a single agent orally once daily in subjects with advanced myeloid~     malignancies; the second portion of the study is a Phase 2 study to define the efficacy and~     safety profile of single-agent SB1518 at the recommended dose in subjects with chronic~     idiopathic myelofibrosis (CIMF).~   "
216930|NCT00719823|"~     The objective of this study is to provide Maraviroc on a compassionate use basis to~     antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent~     unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a~     viable regimen.~   "
216931|NCT00719810|"~     The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341~     (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in~     the treatment of complicated skin and skin structure infections.~   "
216932|NCT00719797|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Giving combination chemotherapy together with bevacizumab may kill more tumor cells.~      PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens~     given together with bevacizumab to see how well they work as first-line therapy in treating~     patients with metastatic colorectal cancer that cannot be removed by surgery.~   "
216933|NCT00719784|"~     Vibration Response Imaging (VRI) is novel technology which records breath sounds via~     pizo-electric sensors and produces a digital image using a computer algorithm. It is~     radiation free and is portable to the patient's bedside. Data exists to show that the~     recordings from normal individuals differs from those who have pulmonary pathology. There is~     also evidence that recordings have high levels of inter and intra-observer reliability.~     However, data on specific VRI patterns for specific pathology is still needed before this can~     be used as a diagnostic tool. We aim to perform an open label feasibility trial on inpatient~     and outpatient pulmonary patients. Bedside clinical examination and chest auscultation will~     be used as the reference gold standard. Other diagnostic modalities that have been used as~     part of the patient's usual standard of care will also be used for comparison. Specifically~     breath sound progression, the maximal sound energy shape/distribution and the presence of~     artifactual sounds will be used to search for patterns that may be used for diagnosis.~     Sensitivity and specificity will be calculated for each disease (eg. asthma, emphysema,~     bronchiectasis, pneumonia, effusion, pneumothorax, etc)~   "
216934|NCT00719771|"~     This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis~     using the anchor pegged glenoid component and clinical and radiographic evaluations.~   "
216935|NCT00719758|"~     The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and~     to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120~   "
216936|NCT00719745|"~     To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing~     primary liver transplantation.~   "
216937|NCT00719732|"~     A prospective evaluation of the visual parameters in a series of patients bilaterally~     implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).~   "
216938|NCT00719719|"~     This study will explore the possible cause of unexplained, or idiopathic, anaphylaxis.~     Anaphylaxis is a rapid, life-threatening, severe reaction that occurs suddenly after contact~     with an allergy-causing substance, usually a particular food, drug or stinging insect. The~     allergen triggers mast cells to release several substances, including histamine. Histamine is~     responsible for many of the symptoms that may occur, such as flushing, hives, swelling of the~     palms and soles or tongue and vocal cords, nasal congestion, itching and tearing of the eyes,~     shortness of breath and wheezing, stomach pain, vomiting, low blood pressure, loss of~     consciousness, shock, and, rarely, death. Severe episodes of anaphylaxis are treated with~     epinephrine (adrenaline), followed by oral antihistamines and steroids. In more than half of~     cases of anaphylaxis, a clear cause is not identified. These cases are called idiopathic~     anaphylaxis. There is no cure or long-term preventive therapy for patients with recurrent~     episodes of idiopathic anaphylaxis.~      People between 13 and 70 years of age who have idiopathic anaphylaxis, or have anaphylaxis~     that is caused by specific allergens such as food, venom, or drugs and medications may be~     eligible for this study.~      Participants are evaluated at the NIH Clinical Center with the following tests and~     procedures:~        -  Medical history, physical examination and blood tests.~        -  Bone marrow biopsy. For this test, the skin over the hipbone and the outer surface of~          the hipbone itself are numbed with local anesthesia. Then, a needle is inserted into the~          hipbone and a small amount of bone marrow is drawn into a syringe. The needle also cuts~          a small core of bone marrow, which is removed for analysis.~        -  Other tests that may be needed for evaluation of the patient s condition.~   "
216939|NCT00719706|"~     The primary objective of this 15-week clinical trial is to test the hypothesis that treatment~     with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA),~     has significantly greater efficacy than placebo as an augmentation treatment in bipolar~     depressed patients who display an incomplete response to conventional treatments.~   "
216940|NCT00719693|"~     Single-dose, open-label, two-period crossover study of ABT-143~   "
217139|NCT00717080|"~     This is a Randomized Controlled Trial to study the role of Capsular Tension Ring in patients~     with Retinitis Pigmentosa~   "
216943|NCT00719654|"~     The hypothesis of this study is that many plasma proteins are altered in concentration and~     structure in preeclampsia and the elucidation of these alterations will add to the poorly~     understood pathophysiology of preeclampsia. In this study we will compare the maternal plasma~     proteomes of early-onset severe preeclampsia versus healthy controls, compare protein~     expression and quantification of the maternal plasma proteome at the time of diagnosis of~     EOS-preeclampsia to the plasma proteome of the same affected subject at 48 hours post~     delivery and we will verify the placental expression of differentially expressed or~     post-translationally modified proteins found in the plasma of women with EOS-preeclampsia.~   "
216944|NCT00719641|"~     This study will test the use of a new device called a segmental stiffening wire (SSW) in~     colonoscopy to correct a problem called looping. Colonoscopy is the best test for detecting~     early colon cancer and removing growths called polyps, which can become colon cancer.~     Sometimes the flexible tube (colonoscope) used in the procedure loops at a certain point as~     it advances through the colon, making it difficult to move further and causing the patient~     pain from excessive stretching of the colon. The SSW is designed to prevent this by~     stiffening the part of the tube that would otherwise form the loop.~      Healthy subjects between 50 and 80 years of age and healthy subjects 40 years and older who~     have a family history of colon cancer may be eligible for this study.~      Participants undergo colonoscopy a day after self-administering a bowel cleansing~     preparation. The first part of the procedure is done similarly to that of a flexible~     sigmoidoscopy, and no sedation or pain medication is used. The colonoscope is inserted into~     the rectum and advanced about one-third the length of the colon. Pain or discomfort should be~     mild to moderate cramping and a feeling of having to move the bowels. The subject is asked to~     score his or her pain level at this point using a standard pain scale. If there is pain, the~     procedure is stopped and an x-ray is taken to determine if the colonoscope has looped. If it~     has, the loop is undone and the SSW is used. Another x-ray is then taken to document that the~     loop has been prevented with the SSW, and the procedure is completed as per standard medical~     practice. Subjects are taken to the recovery area, informed of the test results and then~     discharged home in the care of an accompanying adult.~   "
216945|NCT00719628|"~     The purpose of this study is to investigate if there is an association between the depth of~     anaesthesia and the presence of cognitive deterioration after surgery.~   "
216946|NCT00719615|"~     The purpose of this study is to evaluate Vitamin D levels in thyroid cancer patients with~     active disease compared with thyroid cancer patients in remission and patients with thyroid~     nodules.~   "
216947|NCT00719602|"~     More than 1.5 million deaths of African children under 5 years of age have been due to~     Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance~     each other's progression. The primary purpose of this study is to compare the malarial~     infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or~     non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral~     therapy (HAART).~   "
216948|NCT00719589|"~     The purpose of this study is to determine how many patients who have failed treatment with a~     sacral lead can achieve good results with a pudendal, patients satisfaction with the results~     of each lead, complication rates after pudendal lead placement, and how many patients have~     required reprogramming of their device with EMG testing( a more costly procedure).~   "
216949|NCT00719576|"~     The objective of this trial is to demonstrate superior efficacy and safety of MACI compared~     with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with~     symptomatic articular cartilage defects of the knee.~   "
216950|NCT00719563|"~     RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known~     whether American ginseng is more effective than a placebo in treating cancer-related fatigue.~      PURPOSE: This randomized phase III trial is studying American ginseng to see how well it~     works in treating patients with fatigue caused by cancer.~   "
216951|NCT00719550|"~     Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally~     advanced or metastatic gastric or esophagogastric junction adenocarcinoma.~      Primary Objective(s):~      Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.~      Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the~     addition of AMG 102 to ECX on progression free survival (PFS).~   "
216952|NCT00719537|"~     This study investigates whether low dose aspirin combined with progesterone will decrease the~     risk of preeclampsia in pregnant women with a history of preeclampsia in a previous~     pregnancy.~   "
216953|NCT00719524|"~     The purpose of this study is to determine the recommended dose of the combination of AVE8062~     with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in~     patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of~     care.~   "
216954|NCT00719511|"~     Evaluation of patch as specific immunotherapy in allergic patients~   "
216955|NCT00719498|"~     The purpose of this study is to test the possible neuroprotective effect of early high dose~     erythropoietin alpha after out of hospital cardiac arrest (OHCA).~   "
216956|NCT00719485|"~     This study evaluated the hypothesis that the implementation of an educational program that~     informs spine patients about their condition, treatment options, prioritization on the wait~     list, and post-operative care would improve functional outcome and quality of life scores~     following surgery~   "
216957|NCT00719472|"~     This was a prospective, open-label, Phase III, multicenter, single-arm trial designed to~     assess the safety, pharmacokinetics, and pharmacodynamics of an alternative dosing rate of~     rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and~     follicular non-Hodgkin lymphoma (NHL).~   "
216958|NCT00719459|"~     The primary objective of this study is to assess the bioequivalence of the test product~     Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL~     following intravenous administration to healthy subjects.~   "
216959|NCT00719446|"~     Acute lung injury (ALI) is a severe lung condition that causes respiratory failure. The ARDS~     Network (ARDSNet) is a National Heart, Lung, and Blood Institute-sponsored network that is~     focused on improving treatments for people with ALI and a similar condition called acute~     respiratory distress syndrome (ARDS). This study will evaluate participants who were enrolled~     in one of three ARDSNet studies to examine how the treatments carried out in the prior~     studies affect participants' long-term health outcomes and quality of life.~   "
216961|NCT00719420|"~     More than half of the world's population is infected with Helicobacter pylori, a bacterium~     that colonizes the human stomach. Although most infected subjects live free of symptoms and~     disease outcomes (except superficial gastritis), only a few develop peptic ulcers or gastric~     cancer, while some others may develop non-ulcer dyspepsia. Current clinical practice for the~     management of peptic ulcer disease includes testing for and treating H. pylori, if present.~     Although there are triple therapies that contain 2 antibiotics plus a bismuth compound, a~     proton-pump inhibitor, or a H2-receptor antagonist which are effective at eliminating H.~     pylori in Europe and North America, these treatments are dramatically less effective in~     developing countries. Our recent meta-analysis showed quadruple therapies containing~     clarithromycin, amoxicillin, metronidazole and a proton pump inhibitor to be effective in the~     presence of clarithromycin or metronidazole resistance. However, this regimen has yet to be~     tested in a developing country. Therefore, in the current randomized clinical trial in Pasto,~     Colombia, we aim to examine the effectiveness of clarithromycin, amoxicillin, metronidazole~     with and without a proton pump inhibitor compared to the Food and Drug Administration~     approved 10-day regimen containing clarithromycin, amoxicillin and omeprazole. Since~     antibiotic therapy is most effective within a specific gastric pH range, and since mutifocal~     atrophy results in damage and loss of the acid producing parietal cells, we will test the~     efficacy of our modified therapy stratified by diagnosis of multifocal atrophic gastritis.~   "
216962|NCT00719407|"~     The purpose of this study is to determine the safety and pharmacokinetics of moderate to high~     doses of erythropoietin in newborn infants with birth asphyxia.~   "
216963|NCT00719394|"~     This is a first-in-human study of GSI-136, a gamma-secretase inhibitor being developed for~     the treatment of Alzheimer disease. This study will take place in Japan only and will provide~     an initial assessment of the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of GSI-136 after administration of ascending single oral doses to~     healthy Japanese male subjects and healthy Japanese elderly male subjects.~   "
216964|NCT00719381|"~     The purpose of this study is to determine the effect of pioglitazone on reducing airway~     inflammation in cystic fibrosis and characterize the amount and timecourse of pioglitazone~     elimination from the body.~   "
216965|NCT00719368|"~     Sensory function is different in persistent postherniotomy pain patients than in operated~     controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative~     sensory testing, the specific changes in pain patients will be revealed, thereby aiding in~     designing future treatment trials. MRI scans of the groin regions in pain patients and~     control patients will be evaluated by senior MRI specialists assessing potential pathology to~     the region (Mesh, inflammation, edema, funicle etc.) Assessors will be blinded to clinical~     status, and surgery.~   "
216966|NCT00719355|"~     The purpose of this study is to compare the effects of polestriding (walking with poles) and~     traditional walking on physical endurance in subjects with poor circulation in their legs.~     Another goal is to evaluate the effectiveness of a walking program in increasing the amount~     of oxygen in the calf muscles and therefore improving overall physical activity and quality~     of life.~   "
216967|NCT00719342|"~     It has been shown that diffuse luminance flicker increases retinal and optic nerve head blood~     flow. This indicates that a neuro-vascular coupling between neural activity and blood flow~     exists in the retina as described previously for the brain. Although a lot of mediators such~     as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling is still a~     matter of controversy. However, it has been shown in an animal experiment, that an increase~     in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by decrease in~     pO2 in the tissue. In a recently performed study we could show that breathing of 100% O2 did~     not influence flicker induced changes in the retina and optic nerve head. However, breathing~     of 100% oxygen also leads to a pronounced vasoconstriction of the retinal vessels and in turn~     to a increased tension of the vessel wall. Recent evidence indicates that a combination of~     92% O2 and 8% CO2 can, at least partially, counteract the vasoconstrictory effect of O2 and~     increases tissue pO2. Thus, in this study the investigators set out to investigate the~     flicker light induced increase in blood flow under a mixture of O2/CO2 .~   "
216968|NCT00719329|"~     Background: In developing countries, many babies are born at home and the umbilical cord~     commonly becomes infected during the first week after birth, and can be deadly. Cleansing of~     the cord with a low-cost antiseptic like chlorhexidine may reduce the risk of these~     infections. Little is known, however, about the frequency of chlorhexidine cleansing needed~     to impact upon the overall presence of bacteria on the stump, or regarding the changes in~     bacteria during the first week of life when most cord infections occur.~      Objectives: We will describe the profile of bacteria colonizing the umbilical cord stump of~     infants in rural Bangladesh and examine the role of topical chlorhexidine in altering~     colonization and progress of infection. We will compare the overall and bacteria-specific~     rate of colonization of the cord stump between infants receiving chlorhexidine cleansing of~     their cord through the first day or first week of life. We will also quantify the~     relationship between colonization of the cord stump with specific pathogens and the presence~     and severity of signs of umbilical cord infection (pus, redness, swelling) among these~     newborns.~      Potential Impact: More information is needed on the impact of single versus repeated~     applications of chlorhexidine to the cord stump, as the number of cleansing may substantially~     influence the feasibility of widespread scale-up in many populations. The data generated from~     this proposed study will guide the most appropriate design of this simple intervention and~     will help inform specific treatment protocols for effective management of infants with signs~     of umbilical cord infections.~   "
216969|NCT00719316|"~     The central hypothesis of this project is that Aliskiren causes a substantial decrease in~     MSNA in hypertensive patients with CKD.~   "
216970|NCT00719303|"~     This randomized phase III trial studies whether changes in diet and physical activity can~     increase the length of survival without the return of cancer (progression-free survival)~     compared with usual care in patients with previously treated stage II, III, or IV ovarian,~     fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program~     and counseling may help patients make healthier lifestyle choices. It is not yet known~     whether changes in diet and exercise may help increase progression-free survival in patients~     with previously treated cancer.~   "
217140|NCT00717067|"~     The purpose of this study is to assess whether a dosing adjustment is needed in patients with~     renal impairment.~   "
216971|NCT00719290|"~     The aim of the study is to determine which is the best treatment for people with cataract and~     primary angle closure (PAC).In PAC, apposition of the iris tissue to the drainage channels~     (Trabecular Meshwork-TM) of the eye results in damage and formation of adherences between~     these structures (Peripheral anterior synaechiae-PAS) causing a mechanical obstruction of the~     aqueous outflow via the TM. It is thought that cataract surgery combined with mechanical~     separation of the iris from the TM with the breakage of PAS(we call this separation~     'goniosynechialysis') would make the pressure even lower as it would cause the drain to open~     to a greater extent than cataract surgery alone. This technique is not new, and the results~     have been very encouraging. Comparing this technique to cataract surgery alone however, has~     not been done and this is exactly what we would like to do in order to help us decide what is~     the best treatment.~      In summary, the investigators propose that cataract surgery with goniosynechialysis would~     lower intraocular pressure to a greater extent than cataract surgery alone in patients with~     significant PAS.~   "
216972|NCT00719277|"~     The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring~     system.~   "
216973|NCT00719264|"~     To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to~     bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic~     carcinoma of the kidney.~   "
216974|NCT00719251|"~     The purpose of this study was to compare the effects of high voltage pulsed current and low~     level laser therapy on the healing process of diabetic foot ulcers.~   "
216975|NCT00719238|"~     The long term goals of this project are to develop and implement a combined prenatal and~     postnatal intervention to decrease early childhood caries. The program is based on risk~     assessment, diet intervention and counseling. To accomplish these goals a pilot study is~     needed to determine: 1) The ability to recruit and retain pregnant mothers in an intervention~     program; 2) The levels of S. mutans in pregnant mothers; 3) The ability of a diet~     intervention to decrease S. mutans in pregnant mothers.~   "
216976|NCT00719225|"~     To make belatacept available for recipients of a renal allograft who are currently intolerant~     to or have contraindications to CNIs and/or m-TOR inhibitors and are either:~        -  unable to construct an adequate immunosuppression regimen due to non-renal toxicity /~          contraindication (and withdrawing the causative agent would lead to renal graft loss)~      OR~        -  at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other~          options for renal replacement therapy~   "
216977|NCT00719212|"~     The purpose of this study is to obtain an estimate of the objective response rate (ORR) of~     AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian~     tube and primary peritoneal) carcinoma failing frontline chemotherapy.~   "
216978|NCT00719199|"~     Open-label phase 1b trial. Study treatment will be administered in 3 week cycles.~      There are two distinct parts in this study:~        -  Part 1: Dose escalation from IMO-2055~        -  Part 2: Once a recommended phase 2 dose is found additional tolerability and~          pharmacodynamics will be explored~   "
216979|NCT00719186|"~     The primary research hypothesis is that ovulation induction with an aromatase inhibitor~     (letrozole) is more likely to result in live birth than ovulation induction with a selective~     estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety~     hypothesis will also be incorporated into the primary research hypothesis in which we~     hypothesize both treatments are equally safe for mother and child.~      Secondary research hypotheses include:~        1. Treatment with letrozole is more likely to result in singleton pregnancy compared to~          treatment with clomiphene citrate. Singleton pregnancy is defined as presence of a~          single intrauterine gestational sac with a single fetal pole and observable heart~          motion.~        2. Treatment with letrozole will less likely result in a first trimester intrauterine fetal~          demise than treatment with clomiphene citrate. A first trimester IUFD is defined as a~          pregnancy that ends before 13 weeks gestation.~        3. Treatment with letrozole is more likely to result in ovulation (increased ovulation~          rate) compared to treatment with clomiphene citrate. Ovulation is defined as a midluteal~          progesterone level ≥ 3 ng/mL.~        4. The shortest time to pregnancy will be with letrozole.~        5. Age, body mass index, SHBG, testosterone, LH, Anti-Mullerian Hormone (AMH), and degree~          of hirsutism and acne will be significant predictors of ovulation and conception~          regardless of treatment.~        6. Improvement in SHBG, testosterone, AMH, and LH levels will be significant predictors of~          ovulation and conception regardless of treatment.~        7. DNA polymorphisms in estrogen action genes will predict response to study drug.~        8. Quality of Life will be better on letrozole than clomiphene.~        9. Letrozole will be more cost effective at achieving singleton pregnancies than~          clomiphene.~   "
216980|NCT00719173|"~     RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and~     vomiting in patients undergoing chemotherapy.~      PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works~     compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy for~     breast cancer.~   "
216981|NCT00719160|"~     We have established that dietary protein is an important regulator of intestinal calcium~     absorption in humans. However, we do not understand the mechanism by which dietary protein is~     affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether~     dietary protein-induced changes in gastric acid secretion explain the observed changes in~     intestinal calcium absorption.~   "
216982|NCT00719147|"~     The primary purpose of this study is to compare the incidence of AVN in children with~     hematologic malignancies treated with prednisone versus dexamethasone during continuation.~   "
216983|NCT00719134|"~     Evidence-based medicine depends on distinguishing between pharmacological effects and placebo~     effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate~     fundamental questions concerning pharmacological effects, placebo effects and their~     interactions. Relief of symptoms of acute migraine will be the test condition for this~     scientific experiment because of migraine's evident clinical significance and the possibility~     of using participants as their own control during sequential acute migraine attacks. Our~     overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an~     FDA-proven effective medication for acute migraine) and the effects of placebo treatment can~     be modified by varied knowledge and/or expectation (contextual) conditions. Such knowledge~     has the possibility to suggest potentially more efficient methodologies to test new~     medications that can be used to augment and enhance the apparatus of the RCT.~      General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo~     effect, how such effects vary in different knowledge/expectations contexts, and mutually~     constitute one another and interact.~      General Hypothesis: The measured pharmacological effect of an effective medication~     (rizatriptan) and the measured effect of placebo treatment are determined significantly by~     different knowledge/expectations contexts.~   "
216984|NCT00719121|"~     The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical~     R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation.~   "
216987|NCT00719082|"~     Falls are the greatest cause of accidental death in the elderly. There is no normative data~     on large groups of geriatric subjects specific to their stability scores obtained by~     computerized dynamic posturography (CDP). CDP is the standard test to obtain stability scores~     and is utilized as the gold standard in posturographic evaluations and fall prevention~      Hypotheses:~      Human stability can be measured by CDP. Increased stability is associated with a lessor~     probability of falls. Stability decreases as age increases and a normative data collection of~     stability scores in the geriatric population will allow and promote clinical applications~     which can be utilized in fall prevention.~   "
216988|NCT00719069|"~     This is a single dose inpatient and outpatient study to test whether an effect on the ability~     of platelets to stick to white blood cells in subjects who smoke.~   "
216989|NCT00719056|"~     This is a prospective, open-label, randomized clinical trial where patients were administered~     prophylaxis for total hip or knee arthroplasty either with teicoplanin or with other~     antibiotics. The study is aiming to evaluate any differences between these two different~     strategies of antimicrobial prophylaxis in the occurrence of surgical site infections~   "
216990|NCT00719043|"~     The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is~     immunogenic and safe when given to adults aged >=18 years.~      This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009.~     The impacted sections are study design and outcome measures.~   "
216991|NCT00719030|"~     The purpose of this study is to compare the effects of pomegranate polyphenol pills (POM-X)~     and a placebo (sugar pill) on prostatic oxidative stress. The placebo is a pill that looks~     like the POM-X pill but does not have an active ingredient.~   "
216992|NCT00719017|"~     Recent findings have suggested that laparoscopic surgery is safe and effective, as well as~     laparotomic one, for treating patients with early stage endometrial cancer (ESEC). Moreover,~     our long-term previous data have shown a trend in vaginal cuff recurrence in subjects who~     underwent laparoscopic approach to ESEC consisting of extrafascial hysterectomy, bilateral~     salpingo-oophorectomy, pelvic +/- para-aortic nodes dissections, regardless grading or~     lymphovascular space invasion.~      Based on these considerations, the aim of the current protocol-study will be to compare two~     different strategies for vaginal cuff recurrences prevention in patients affected by ESEC~     treated with laparoscopic surgery. In particular, upper vaginectomy followed by observation~     will be compared to post-operative brachytherapy.~   "
216993|NCT00719004|"~     The purpose of this study is to study normal sonographic(ultrasound)anatomy of the soft~     tissues of the foot in normal volunteers.~   "
216994|NCT00718991|"~     This investigation is designed to assess the immediate and long-term angiographic patency~     outcomes of excimer laser recanalisation followed by PTA in the treatment of long (>50 mm)~     infrapopliteal lesions in patients with critical limb ischemia (CLI)~      The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular devices~     constructed of multiple optical fibers around a guidewire lumen. The laser catheters transmit~     ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the obstruction in~     the artery. The ultraviolet energy is delivered to the tip of the laser catheter to~     photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing diseased vessels.~   "
216995|NCT00718978|"~     The aim of this work was to present the investigators experience in the use of autologous~     three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes,~     melanocytes and fibroblasts attached to a scaffold of hyaluronic acid. This method represents~     a surgical alternative in the treatment of a variety of pathologies, including burns, ulcers~     and giant nevi.~   "
216996|NCT00718965|"~     The present study is aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg)~     in a double-blind comparison with placebo in the management of patients with primary~     hypercholesterolemia. The main objective is to evaluate the effects of AVE5530 on LDL-C level~     reduction as adjunct to a controlled diet. The effects of AVE5530 on other lipid parameters~     will be assessed as secondary objectives.~   "
216997|NCT00718952|"~     The purpose of this study is to evaluate the efficacy and safety of vardenafil in the~     treatment of pulmonary arterial hypertension.~   "
216998|NCT00718939|"~     The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind~     trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be~     followed up to one year post implant.~   "
216999|NCT00718926|"~     Dry eye disease is related with oxidative stress at the ocular surface. GSH is one of the key~     factor of protect from oxidative stress. To evaluate thiol status of ocular surface cells by~     monitoring GSH concentration, we can evaluate the severity of dry eye.~   "
217000|NCT00718913|"~     This study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for~     patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal~     junction.~   "
217001|NCT00718887|"~     Switching to Entecavir will result in superior antiviral efficacy as compared to continuing~     with Adefovir in patients with a suboptimal response to Adefovir~   "
217002|NCT00718874|"~     A diet (42% carbohydrate) specialized to the unique metabolic characteristics of peripubertal~     African AMerican girls (hyperinsulinemic, low insulin sensitive) will be more effective in~     maintaining glucose and insulin homeostasis compared to a standard diet (55% carbohydrate)~   "
217003|NCT00718861|"~     This second extension will evaluate the efficacy and long term safety of zoledronic acid in~     women with post-menopausal osteoporosis~   "
217004|NCT00718848|"~     Background: Recent data indicate that home nocturnal hemodialysis (8 hours of hemodialysis at~     home for 5-6 nights per week) may have substantial cardiovascular benefits, including~     regression of left ventricular (LV) hypertrophy, improved LV ejection fraction and blood~     pressure control. Nevertheless, this dialysis modality is only feasible in a highly-selected~     minority of ESRD patients, who can self-manage their dialysis treatment at home. In-centre~     nocturnal hemodialysis (INHD), administered as 7-8 hours of hemodialysis in hospital for 3~     nights per week, represents an appealing and practical alternative. As this is a novel form~     of therapy, there has been no definitive study examining the cardiovascular impact of INHD to~     date.~      Objective: To determine the effects of INHD on LV mass, global and regional systolic and~     diastolic function, and other cardiovascular biomarkers in patients with ESRD.~      Hypothesis: Conversion from conventional hemodialysis to INHD is associated with favourable~     changes in cardiac structure and function in patients with ESRD.~      Rationale for Using Cardiac MRI: Cardiac magnetic resonance imaging (CMR) has emerged as the~     new gold standard for measuring LV mass, volume, global and regional myocardial function. Its~     accuracy and precision make it the imaging modality of choice for studying the small number~     of patients currently undergoing or awaiting INHD.~      Study Design and Population: This is a prospective cohort study of adult ESRD patients who~     are currently receiving conventional in-centre hemodialysis and will be converted to INHD.~     Patients will be managed as per standard clinical practice (e.g. blood pressure, anemia~     management) established for the INHD program, and no therapeutic intervention will be~     performed as part of this study. All eligible patients will undergo two serial CMR~     examinations: within 2 weeks prior to conversion and at 52 weeks following conversion to~     INHD. We also plan to recruit a population of control patients who have elected to remain on~     conventional HD. These individuals will be asked to undergo the same set of investigations at~     baseline and 12 months thereafter.~      Outcome: The primary endpoints are the temporal changes in LV mass and size, global and~     regional diastolic and systolic function at 52 weeks after conversion to INHD, as measured by~     cardiac MRI. Secondary endpoints include changes in myocardial tissue characteristics, blood~     pressure, mineral metabolic parameters, anemia control, serum troponin, norepinephrine, brain~     natriuretic peptide, markers of inflammation and quality of life.~      Significance: The provision of an enhanced dialysis regimen has emerged as the most promising~     avenue through which to modify the dismal cardiovascular outcomes in patients receiving~     chronic hemodialysis. INHD represents a means of administering such therapy to a broad~     spectrum of dialysis patients for whom home therapies would not be feasible. The proposed~     study will be the first to precisely define the cardiac impact of INHD using CMR. The~     findings may justify large randomized controlled trials evaluating clinical outcomes. If INHD~     is proven to be effective, it will have a major impact on the management and outcome of many~     patients with ESRD in Canada.~   "
217005|NCT00718835|"~     The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such~     as methadone or buprenorphine maintenance, is more than three-fold that of the general~     population and is associated with increased morbidity and mortality. The overarching goal of~     this project is to systematically develop a voucher-based contingency-management (CM)~     intervention for promoting initial and longer-term abstinence from cigarette smoking in~     patients receiving methadone or buprenorphine treatment for their opioid abuse.~   "
217006|NCT00718822|"~     The purpose of this study is to assess whether reduced oxygen tension in embryo culture has~     any effect on clinical outcome.~   "
217007|NCT00718809|"~     This phase II trial is studying how well saracatinib works in treating patients with relapsed~     or refractory thymoma or thymic cancer. Saracatinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth~   "
217008|NCT00718796|"~     This study is designed to test the ability of a comprehensive naturopathic approach to reduce~     important risk factors for the development of cardiovascular disease. Treatment will take~     place over the course of one year and the comparator/control group will be followed by their~     medical doctors and be given conventional care.~   "
217009|NCT00718783|"~     Retinoblastoma is a childhood tumor of the retina that affects approximately 1 in 18,000~     children. Retinoblastoma is more prevalent in Central America, where most patients present~     with advanced intraocular and extraocular disease. Therefore, we have formed collaboration~     with Central American investigators to provide us with frozen retinoblastoma tumors from~     patients undergoing routine enucleation. The objective of this protocol is to begin to~     identify the mutations and gene expression changes that occur in retinoblastoma cells~     following RB1 gene inactivation in order to more effectively target chemotherapy for treating~     bilateral retinoblastoma.~   "
217010|NCT00718770|"~     This study plans to learn more about a drug called bexarotene for the treatment of advanced~     thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that~     will not respond to radioactive iodine therapy and shows signs of aggressive behavior.~      Bexarotene has been FDA approved for the treatment of a type of skin cancer called cutaneous~     T-cell lymphoma, but has not been FDA approved for this use. Bexarotene is investigational in~     the treatment of thyroid cancer.~      The purpose of this research study is to test how well the study drug works in humans. The~     study doctors want to know if:~        1. The subjects thyroid cancer gets smaller while you are taking the study drug.~        2. The subjects thyroid cancer takes up radioactive iodine better after treatment with the~          study drug than before treatment.~   "
217011|NCT00718757|"~     The purpose of this study is to estimate the maximum tolerated dose of dexamethasone given~     for 5 consecutive days when combined with fixed doses of irinotecan (given IV, qd x 5, 2 days~     off, qd x 5) and vincristine (given IV, 2 doses total on days 1 and 8 of schedule) in~     children with relapsed or refractory hematologic malignancies. In addition we will also study~     the pharmacokinetics of irinotecan when given without and then with dexamethasone in each~     patient, evaluate the relationship between irinotecan pharmacokinetic parameters and toxicity~     and describe any antitumor effects.~   "
217012|NCT00718744|"~     The main purpose of the trial is to prove the therapeutic value of the product and enable an~     effective and safe dosage schedule to be recommended~   "
217013|NCT00718731|"~     This is a first-in-humans study of GSI-136, a drug being developed for the treatment of~     Alzheimer Disease. The main purpose of this study is to determine whether GSI-136 is safe and~     tolerable in healthy young and healthy elderly subjects. The amount of drug in the body and~     the effects of the drug on the body will also be evaluated at certain timepoints.~   "
217014|NCT00718718|"~     The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under~     the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing~     signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate~     (MTX) therapy.~   "
217015|NCT00718705|"~     The purpose of this study is to test the effectiveness of an antibiotic treatment (Josamycin)~     in the case of positive PCR for Ureaplasma spp. and/or Mycoplasma hominis in the second~     quarter on the risk of premature birth.~   "
217016|NCT00718692|"~     This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label~     trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will~     receive a single IV dose of Sym001.~   "
217017|NCT00718679|"~     This study is placebo controlled, double blind, randomised, two arm dose escalation of a new~     product for specific immunotherapy in cat allergic patients~   "
217018|NCT00718666|"~     In this study, the concentration of antibody to the vaccine one year, three and five years~     after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine~     GSK134612 in a previous study (whose objectives & outcome measures are presented in a~     separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune~     response of a booster dose of vaccine GSK134612 administered at 5 years post-primary~     vaccination will also be evaluated. In addition, the immune response to a dose of vaccine~     GSK134612 administered to age-matched controls not previously given a meningococcal vaccine~     will be evaluated.~      This protocol posting has been updated further to protocol amendment 2, dated 28 october~     2010. The sections impacted are summary, study design, outcome measures, intervention, and~     eligibility criteria.~   "
217019|NCT00718653|"~     Age-related macular degeneration (AMD) is the leading cause of blindness in the United~     States. Low dietary intake or low blood levels of lutein and zeaxanthin, which are the only~     pigments found in the macular region of the human retina, has been associated with an~     increased risk for AMD. We have reported that the dietary supplementation of lutein and~     zeaxanthin can increase the macular pigments (MP) of the eye. MP effectively absorbs blue~     light as well as quenches reactive oxygen species (ROS). Green tea polyphenols are also~     effective scavenger of ROS in vitro.~      Our goal is to elucidate how to effectively increase MP by physiologic levels of antioxidant~     supplementation. We hypothesize that lutein and tea polyphenols protect the macula of the eye~     by increasing MP carotenoids effectively through an antioxidant mechanism.~   "
217020|NCT00718640|"~     The purpose of this study is to evaluate the effectiveness and safety of bortezomib in~     participants previously treated for multiple myeloma (cancer of plasma cells in bone marrow~     causing numerous tumors and characterized by the presence of abnormal proteins in the blood)~     with limited kidney function.~   "
217021|NCT00718627|"~     Urea cycle disorders are rare inherited diseases that generally have a poor outcome. In this~     study, neonates and infants with UCD will be included within the first 3 months of life and~     will be treated by repetitive application of human liver cells to reduce the risk of~     neurological deterioration while awaiting OLT.~   "
217043|NCT00718341|"~     This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in~     patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary~     read-out of efficacy is reduction in Aberrant-Behavior Checklist score.~   "
217044|NCT00718328|"~     Study Objective: To analyze if statins are effective in ameliorating perihematomal edema~     evolution thereby reducing mortality and improving functional outcomes following spontaneous~     intracerebral hemorrhage (ICH).~   "
217022|NCT00718614|"~     There is evidence from a variety of animal studies that choroidal blood flow is under neural~     control. Recent results in humans indicate that a light/dark transition is associated with a~     short lasting reduction in choroidal blood flow. Several observations indicate that the~     changes in choroidal perfusion are triggered at least in part by neural mechanisms.~     Particularly, we have shown that during unilateral dark/light transition both eyes react with~     choroidal vasoconstriction strongly indicating a neural mechanism for blood flow regulation.~     Investigation of changes in choroidal blood flow during light/dark transition may represent~     an interesting approach to study neural dysregulation at the level of the eye in patients~     with IDDM. Accordingly, the hypothesis of reduced choroidal blood flow responses to a~     light/dark transition in patient with IDDM will be tested. This response in choroidal blood~     flow will be correlated to parameters of diabetic neuropathy and diabetic retinopathy.~   "
217023|NCT00718601|"~     The purpose of this study is to determine safety and the maximum tolerated dose (MTD) of~     GRN163L and Velcade with and without Decadron when administered to patients with refractory~     or relapsed multiple myeloma.~   "
217024|NCT00718588|"~     This is a Phase I multicenter study that will be conducted in the United States and consists~     of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo~     controlled MAD stage. The study will be conducted in approximately 65 adult patients between~     18 and 80 years old who have RA.~   "
217025|NCT00718575|"~     Standard liver retrieval procedures for transplantation from a deceased donor inevitably~     result in a reperfusion injury to the liver tissue. The purpose of this research study is~     to find out whether treatment of the liver with a preconditioning protocol before its~     removal from the donor will help reduce any of this injury.~      The preconditioning treatment being tested has two components. Firstly, a solution of~     glucose+insulin is infused and secondly, blood flow to the liver is stopped briefly (10~     minutes) and then resumed. Both strategies, individually, have been shown to reduce liver~     tissue injury in human studies.~      We hypothesize that combining both strategies will have a clinical benefit to patients and~     will improve liver function following transplant.~   "
217026|NCT00718562|"~     This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal~     tumors patients who failed imatinib and sunitinib therapy.~   "
217027|NCT00718549|"~     This study will assess the effect of maintenance treatment with MabThera,in comparison with a~     2 year observation period (no treatment),in patients with progressive B-cell chronic~     lymphocytic leukemia who have had previous first-line induction treatment with MabThera (RCC~     regimen).After 6 months of induction therapy with RCC (MabThera + cladribine +~     cyclophosphamide) patients will be randomized either to receive maintenance treatment with~     MabThera (375mg/m2 iv every 12 weeks, or to receive no treatment (observation only).The~     anticipated time on study treatment is 2+ years, and the target sample size is 100-500~     individuals.~   "
217028|NCT00718536|"~     The co-administration of raltegravir with medicinal products that are knouwn to be potent~     UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once~     daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate~     therapeutic option in HIV-infected patients also receiving atazanavir-containing~     antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are~     recovered.~   "
217029|NCT00718523|"~     This study will determine the value of adding AMG 479 (fully human monoclonal antibody~     against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with~     optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian~     epithelial (including fallopian tube and primary peritoneal) carcinoma.~   "
217030|NCT00718510|"~     STUDY OBJECTIVES: To determine whether the addition of L-arginine to treatment as usual (TAU)~     in schizophrenia further improves and enhances therapeutic efficacy (positive, negative and~     depressive symptoms) and effectiveness of antipsychotic treatment~      STUDY POPULATION: Patients diagnosed (DSM-IV criteria) with schizophrenia or schizoaffective~     disorder~      Total expected number of patients: 14~      INVESTIGATIONAL COMPOUND: L-arginine capsules, 3 grams of L-arginine given twice a day (total~     daily dose of 6 grams/day)~      DURATION OF ACTIVE TREATMENT: 3 weeks followed by wash-out phase of 5 days and 3 weeks of~     second treatment phase (cross-over design)~      EVALUATION CRITERIA: Primary (efficacy) outcomes: PANSS scores. Secondary outcomes: Calgary~     Depression Scale for schizophrenia, CGI; AIMS, UKU-assessment of side-effects~      ASSESSMENT SCHEDULE: Treatment arm 1: Baseline, weeks: 1,2,3, wash-out phase; week 4,~     cross-over phase: treatment phase-2; weeks 5,6,7~      STATISTICAL CONSIDERATIONS: Analysis of variance of outcome measures with treatment as the~     between-subject factor and pre- and post-treatment scores as within- subjects factors.~      DURATION OF STUDY PERIOD: Patient recruitment to be completed in 12 months, study full~     completion 18 months.~   "
217031|NCT00718497|"~     New technologies are giving people with motor disabilities alternative communication and~     control channels. The investigators are interested in using the Cyberlink Control System as a~     hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS).~     The goal of this project is to determine whether this device is a practical and realistic~     means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye~     movements.~      The benefit of this study may be of substantial value to many people with severe motor~     impairment. Additionally, it is hoped that some of the study subjects may benefit by~     incorporating hands-free computer use into their daily lives.~      This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily~     communication compared to the standard manual letter board.~   "
217032|NCT00718484|"~     This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris~     administered with doxorubicin in combination, compared with single-agent doxorubicin~     administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS).~     Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive~     palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will~     be anthracyclin naïve.~   "
217033|NCT00718471|"~     Randomized evaluation of enoxaparin (0.5mg/kg IV) versus UFH (50-70IU/kg with GPIIb/IIIa~     inhibitors; 70-100IU without GPIIb/IIIa inhibitors). Anticoagulation can be continued after~     the procedure using the same agents as those allocated per randomization (enoxaparin SC, UHF~     IV or SC)~   "
217157|NCT00716846|"~     The purpose of this study is to investigate whether statins have any influence on cytochrome~     P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.~   "
217034|NCT00718458|"~     Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular condition characterized by~     weakness, muscle wasting, fasciculations and increased reflexes. Depending on the site of~     onset, individuals with ALS progressively lose control of their skeletal muscles; bulbar or~     the extremities. As symptoms worsen and spread, muscle atrophy becomes apparent and upper~     motor neuron symptoms such as spasticity complicate gait (in lower limb involvement) and~     manual dexterity (in upper limb involvement). The patients progress to a state of profound~     disability and have great difficulty in communicating; some may even be entirely locked in~     to their bodies. The capacity for simple communication could greatly improve their quality of~     life.~      New technologies are giving people with disabilities alternate communication and control~     options. One such instrument is the EEG-based Brain-Computer Interface (BCI) which can~     provide both communication and control functions to those who have lost muscle control. By~     recording electroencephalographic (EEG) signals or brain waves from the scalp and then~     decoding them, the Wadsworth BCI allows people to make selections on a computer screen [i] In~     this study we will be investigating the feasibility of using EEG-based Brain-Computer~     Interface technology as a communication solution for individuals with ALS. The specific~     question addressed will be: Can individuals with ALS use the BCI for communication when they~     present with extreme loss of neuromuscular control and severe communication impairments? The~     goal of the project is to determine whether this device is a practical and realistic means~     for individuals with ALS to communicate. The study is intended to evaluate both the~     complexity of the system and the degree to which each participant will be able to~     communicate. Trials will consist of asking the subject to follow a series of simple~     instructions and complete certain tasks while using the BCI.~      This study design requires that the individual live in the Philadelphia region. Please~     contact the Wadsworth Center of the New York State Department of Health and State University~     of New York at Albany directly if you reside outside of this area.~   "
217035|NCT00718445|"~     In order to streamline disease research in ALS and other motor neuron diseases, we have~     joined a consortium of clinical centers (Hershey and University of Pittsburgh) who will~     collaborate on clinical and basic research projects. As part of this collaboration,~     de-identified clinical data from subjects at each institution will be entered into a joint~     database kindly provided and maintained by the ALS Hope Foundation. This database is password~     protected and contains only de-identified information. In addition to clinical data, any~     research specimens that are available through IRB approved tissue collections will be linked~     to the subject so that the collaborating investigators can share samples and have the maximum~     information. This will enhance the usefulness of each specimen.~      Once established, the database will provide a resource in which clinical data on a large~     number of patients along with tissue (blood, urine, muscle, csf, and autopsy) samples will be~     readily available. This will expedite research by circumventing the delays in collecting~     specimens prospectively and increase the number of specimens available by allowing the~     collaborating researchers access to each others specimens. In each case there will be a~     formal request placed to use specimens that are at the other institutions. These specimens~     will be used for research in the ALS Center of Hope at the Drexel University College of~     Medicine and shared with outside investigators with valid IRB approved protocols.~   "
217036|NCT00718432|"~     Frailty, osteoporosis, and depression are three highly prevalent geriatric syndromes. Having~     these conditions are associated with adverse outcome in physical health, mental health,~     quality of life, and daily functioning. They are associated with higher mortality rates as~     well as increased health care cost. Risk factors, pathogenesis, clinical phenotypes, and~     interventions of these three geriatric syndromes are often related. Frailty is often defined~     as accumulations of multi-system deficiencies with increased vulnerability to multiple worse~     outcomes. Multifactorial, interdisciplinary integrated care models targeting frail older~     adults may have positive impacts on measurements associated with not only frailty, but also~     depression, or osteoporosis. The objective of this proposed study is to conduct a randomized~     control trial (RCT) to exam the effectiveness of integrated interventions on multiple~     outcomes among community-dwelling Taiwanese elders with high risks for frailty and/or~     osteoporosis, depression. We also plan to determine the differential effects of intervention~     between urban and rural area.~   "
217037|NCT00718419|"~     To determine whether further study of single-agent enzastaurin is warranted in patients with~     previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.~   "
217038|NCT00718406|"~     The primary aim was to evaluate the relief of chest pain during the first 30 minutes among~     patients who received metoprolol alone as compared with metoprolol plus morphine~   "
217039|NCT00718393|"~     Amyotrophic lateral sclerosis is a uniformly progressive and fatal neurodegenerative disorder~     for which there is no known cure. In a novel attempt to widen the search for potential~     therapeutic agents, a NINDS- led cooperative group performed an in-vitro screening program of~     1040 FDA approved drugs in over 28 assays relevant to various neurodegenerative disorders.~     Several cephalosporins showed hits in ALS relevant assays. Efficacy was noted in models~     suggesting increased expression of the astrocytic glutamate transporter, EAAT2, as well as~     models of superoxide dismutase mediated toxicity. Ceftriaxone is a third generation~     cephalosporin with good CNS penetration, a long half-life, and was effective in both types of~     ALS assays. Ceftriaxone has calcium binding activity, antioxidant properties, and rescues~     motor neurons in culture from chronic glutamate toxicity. Since completion of the original~     NINDS screen, Ceftriaxone has been shown to increase by three fold EAAT2 activity in rodent~     brains, due to ceftriaxone's ability to increase EAAT2 promotor activation This program is~     for the use of ceftriaxone in ALS for compassionate care. Currently ceftriaxone is approved~     by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for~     treating ALS. However, there is an ongoing phase I study -by NEALS Consortium and the~     National Institute of Health- with three cohorts -a placebo group and two groups receiving~     either 2 or 4 grams of ceftriaxone daily-. Unfortunately there are only a limited number of~     patients being enrolled and the next phase of the project will not be undertaken until next~     year. At this point there are ALS patients unable to participate in this Phase I trial and~     unlikely to be alive when the next phase of study begins. Some of these patients want to~     receive the drug and are willing to pay for the drug and nursing care. We are therefore~     requesting a compassionate use protocol for these patients who request the medication and are~     willing to pay for the drug and nursing care to administer it. Dr. Terry Heiman-Patterson~     will supervise the administration and safety monitoring including labs for renal and hepatic~     function as well as IV site inspection.~   "
217040|NCT00718380|"~     The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of~     ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was~     determined in a previous the M04-710 study.~   "
217041|NCT00718367|"~     The objective of the study is to determine whether a specific immune microenvironment in the~     primary tumor is associated with a favorable clinical course after nephrectomy and in the~     absence of adjuvant treatment.~   "
217042|NCT00718354|"~     Due to evidence available both in terms of efficacy and safety of low molecular weight~     heparin, its use for the prevention of thromboembolic disease in cancer patients undergoing~     surgical intervention, and its extended use in higher doses for the prevention of recurrent~     thromboembolism in cancer patients with established thrombosis, with a view that the~     potential benefits for survival in cancer patients from low molecular weight heparin therapy~     comes because of a biological activity, the dose of 1mg/Kg (50% of the full treatment dose)~     for a period of 6 months coincident with 6 cycles of chemotherapy, has been chosen for this~     study.~   "
217045|NCT00718315|"~     This 3 arm study will compare the efficacy and safety of three different dermatological~     creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients~     with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have~     recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily~     treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity~     of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the~     target sample size is 100-500 individuals.~   "
217046|NCT00718302|"~     The role of operative fixation of unstable, displaced lateral malleolus fractures is~     well-established (Mayer, Mak, and Yablon). However, the optimal type of fixation remains the~     subject of debate. Lag screw fixation alone is only appropriate for long oblique fractures in~     younger patients (Tornetta). For all other patients, the choices for fibular stabilization~     most commonly involve the use of plates and screws which can be placed on either the lateral~     or posterior side of the bone, with or without lag screws. Lateral plating remains the most~     popular option, but since the description of posterior plating in 1982 (Brunner), reports in~     the literature have demonstrated some advantages of posterior over lateral plating (Ostrum,~     Treadwell, Winkler, and Wissing) . These advantages include less dissection, less palpable~     hardware, and decreased likelihood of intra-articular screw placement. However, there is only~     a single retrospective study in the published literature directly comparing these two methods~     (Lamontagne).~   "
217047|NCT00718289|"~     Background:~      A concentrate for bicarbonate haemodialysis acidified with citrate instead of acetate has~     been marketed in the recent years. The small amount of citrate used (one-fifth of the~     concentration adopted in regional anticoagulation) protects against intradialyser clotting,~     minimally affecting the calcium concentration. The aim of this study is to compare the impact~     of a citrate- and acetate-based dialysate on systemic haemodynamics, coagulation, acid-base~     status, calcium balance and dialysis efficiency.~      Methods:~      In 25 patients, 375 dialysis sessions, we will compare acetate (A) with citrate dialysate~     with (C+) or without (C) calcium supplementation (0.25mmol/L) in a randomized single blind~     cross-over study. Systemic haemodynamics will be evaluated using pulse wave analysis systems.~     Coagulation, acid-base status, calcium balance and dialysis efficiency will be assessed using~     standard biochemical markers.~   "
217048|NCT00718276|"~     We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on~     25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study~     including 35 postmenopausal women.~        -  Trial with medicinal product~   "
217049|NCT00718263|"~     This study will evaluate the safety and tolerability of nilotinib after failure of imatinib~     therapy or imatinib therapy after nilotinib failure.~   "
217050|NCT00718250|"~     The purpose of this study is to assess the safety and tolerability of an 'AML Cell Vaccine'~     in patients with poor prognosis acute myeloid leukaemia (AML).~   "
217051|NCT00718237|"~     The purpose of the study is to evaluate whether V260 is effective and well tolerated in~     Japanese healthy infants.~   "
217052|NCT00718224|"~     The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with~     Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing~     elective knee replacement surgery.~      The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing~     elective knee replacement surgery, and to document AVE5026 exposure in this population.~   "
217053|NCT00718211|"~     To review the characteristics and treatment of gastrointestinal tumours at the two tertiary~     centres in Singapore~   "
217054|NCT00718198|"~     This study is a retrospective cross-sectional study at one institution, where the~     investigators compared diabetic patients admitted to Medicine Services from March-April 2006~     (before CPOE was implemented) to patients admitted from October-November 2007 (one year after~     CPOE implementation). Capillary blood glucose values, Hemoglobin AIC, diabetes medication~     profile and demographic data were obtained to compare between groups. The investigators~     hypothesized that a computer-based protocol that emphasizes basal-bolus and correctional~     insulin orders and excludes sliding scale, in conjunction with nursing personnel inservicing,~     improves outcomes.~   "
217055|NCT00718185|"~     The study is being done to investigate what happens to sildenafil in the body and how long it~     takes to get rid of this drug. Understanding how long the drug stays in the body and how it~     is changed by the body will help doctors determine the best dose. We also want to learn how~     well the medicine works based on the size of the dose or amount in the bloodstream.~   "
217056|NCT00718172|"~     Up to 120 patients with chronic hepatitis C will be enrolled in a study of viral kinetics and~     liver gene expression before and during combination therapy with peginterferon and ribavirin.~     Adult patients with chronic hepatitis C virus (HCV) infection who have compensated liver~     disease and have not received interferon in the past will be randomized into one of four~     groups. Groups A and C will undergo liver biopsy before starting peginterferon therapy and~     Groups B and D will undergo biopsy 6 hours after the initial dose of peginterferon.~     Furthermore, Groups C and D will receive a run-in period of 4 weeks of ribavirin therapy~     before starting peginterferon. All patients will receive the standard recommended doses of~     peginterferon alfa 2a (180 mcg sc weekly) and ribavirin (1000 or 1200 mg daily for genotypes~     1, 4-6 and 800 mg daily for genotype 2 and 3) for up to 48 weeks (24 weeks for genotype 2 and~     3). All patients in Groups C and D, irrespective of genotype, will be pretreated with~     ribavirin at a dose of 1000 or 1200 mg, depending on patient body-weight. After the initial~     peginterferon injection, patients will have blood taken and symptoms recorded at 6, 24, 48,~     72 hours and weekly thereafter for four weeks to assess viral kinetic response. Liver biopsy~     tissue taken before or 6 hours after the initial dose of peginterferon will be assessed by~     standard light microscopy and also subjected to RNA extraction and microarray analysis of~     mRNA expression. Patients will be monitored carefully during therapy and tested regularly for~     HCV RNA levels. Therapy will be given for 48 weeks, but will be discontinued early for~     patients with genotype 1 infection if HCV RNA levels do not decline by at least 2 log IU/ml~     by week 12 (lack of an early virological response) or do not decline to undetectable levels~     by week 24 (lack of HCV RNA clearance). Patients with other genotypes with be treated for a~     full course of therapy regardless of early responses. After completing therapy, patients will~     be followed at 4 to 8 week intervals and undergo repeat medical evaluation with liver biopsy~     24 weeks after stopping therapy.~      The primary clinical criterion for success of therapy is a sustained virological response, as~     marked by the absence of HCV RNA from serum at least 24 weeks after stopping. The focus of~     this study, however, will be on viral kinetics comparing patients who were pretreated with~     ribavirin (Groups C and D) to those who were not (Groups A and B) as well as on gene~     expression studies assessing the effects of peginterferon on intrahepatic mRNA profiles by~     comparing Group A and B and the effects of ribavirin by comparing Group A to Group C and~     Group B to Group D. Results will also be compared between different HCV genotypes. These~     studies are aimed at assessing the mechanisms of action of peginterferon and ribavirin~     against HCV and evaluating the basis for the lack of virologic response to combination~     therapy.~   "
217057|NCT00718159|"~     The purpose of this study is to determine a safe dose of LY573636-sodium to be given to~     patients with acute myeloid leukemia and to determine any side effects that may be associated~     with LY573636-sodium in this patient population. Efficacy measures will also be used to~     assess the activity of LY573636-sodium in acute myeloid leukemia and essential~     thrombocythemia patients.~   "
217179|NCT00716560|"~     The purpose of this study is to observe the incidence of nausea with systemic chemotherapy~     that includes consecutive days (more than one day)of cisplatin medication.~   "
217058|NCT00718146|"~     This study is for a new marketing authorization application for the seasonal vaccine strains~     in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza~     vaccine from the Committee for Human Medicinal Products (CHMP)~      Objectives:~        -  To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion~          influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG~          CPMP/BWP/214/96.~        -  To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009~          formulation.~   "
217059|NCT00718133|"~     Haifa bay region is located close to a major industrial zone. The aim of the study is to~     evaluate the health status of children living in Haifa bay region.~      The health status will be evaluated using health questionnaires and spirometry.~   "
217060|NCT00718120|"~     This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split~     virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.~   "
217061|NCT00718107|"~     The purpose of this study is :~        1. To assess the ALS patient's satisfaction related to a hospital stay on the neurology~          floor of Hahnemann Hospital.~        2. To compare the reported satisfaction of those individuals who stayed in a standard~          hospital room with those who stayed in Room 1455. Room 1455 is a room specifically set~          up with assistive technology related to environmental controls for individuals with~          disabilities.~        3. To look at frequency of use of the various pieces of adaptive equipment.~   "
217062|NCT00718094|"~     Green tea consists of several components, with most research focusing on the polyphenol~     fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied~     extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has~     been shown to effectively reduce the inflammation associated with animal models of~     inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the~     form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.~   "
217063|NCT00718081|"~     The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a~     placebo (or sugar pill) for the treatment of post-operative pain in subjects following~     abdominal surgery. We hypothesize that subjects receiving placebo will have poor pain relief~     and will drop out of the study sooner and more often than the ARX-F01 treated subjects.~   "
217064|NCT00718068|"~     Patients in critical care often require supplemental potassium chloride if levels in their~     blood are below acceptable level. Common practice is to administer a single dose of potassium~     chloride under controlled conditions via a drip, before checking if a further dose is~     required. The purpose of this study is to ensure that it is safe to administer potassium~     chloride continuously with the dose varied according to patient needs.~   "
217065|NCT00718055|"~     The purpose of this study is to determine whether MRI with manganese containing contrast~     agent detects more livermetastasis compared to CT scan~   "
217066|NCT00718042|"~     Protocol designed to test blood samples from blood donors of whole blood and blood components~     using a new investigational screening test (PRISM Chagas) that detects antibody to T. cruzi~     (Chagas infection). Results will be compared to the current T. cruzi antibody screening~     assay. Specimens positive with the screening assay will be further tested with a new~     investigational Chagas confirmatory assay [Enzyme Strip Assay (ESA) Chagas]. Additional~     specimens collected under separate protocols or sourced from suppliers will also be provided~     to the clinical sites for testing with PRISM Chagas assay and ESA Chagas.~   "
217067|NCT00718029|"~     The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid.~      The hypotheses are:~        -  Raltegravir concentrations in CSF will be measurable~        -  Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary~          widely leading to highly variable CSF-to-plasma ratios.~        -  Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels~          in CSF will be below 50 copies/mL in all subjects.~   "
217068|NCT00718016|"~     The goal of this project is to determine whether this device is a practical and realistic~     means for ALS patients to operate their computers with only the use of facial, brainwave, and~     eye movements. This study is intended to evaluate both the complexity of the system and the~     degree to which complications of ALS (such as severity of involuntary movements) may~     interfere with the use of cyberlink.~   "
217069|NCT00718003|"~     The literature to date indicates that noninvasive positive pressure ventilation (NIPPV)~     provides effective noninvasive ventilator support, prolongs survival, and improves quality of~     life (QOL) in Amyotrophic Lateral Sclerosis (ALS) patients. It is generally recommended to~     patients when their pulmonary function testing demonstrates a drop to 50% forced vital~     capacity (FVC). One result of using NIPPV may be a reduction in the work of the breathing~     which would lead to decreased caloric needs. However, the work of breathing and the effects~     of noninvasive ventilation on caloric use have not been studied in patients with ALS. This is~     extremely important since there may be a reduction in the caloric needs when ALS patients are~     placed on NIPPV and if the caloric intake is not adjusted, overfeeding can occur. Overfeeding~     with too many calories can lead to an increase in carbon dioxide which would actually worsen~     the respiratory failure.~      The overall aim of this project is to evaluate how many calories are used by ALS patients~     while at rest, when placed on NIPPV, and when breathing against a resistance. This will be~     accomplished using a metabolic cart during these activities. At present, the metabolic cart~     is routinely used in ALS patients at the time of feeding tube placement to calculate caloric~     needs. Using the cart to calculate the caloric expenditure on and off the ventilator will aid~     in calculating the work of breathing and the effects of NIPPV on work of breathing.~   "
217070|NCT00717990|"~     This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in~     patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and~     Avastin.~   "
217085|NCT00717782|"~     Thrombosed external haemorrhoids are one of the most frequent anorectal emergencies. They are~     associated with swelling and intense pain. This study evaluated the efficacy and safety of an~     intersphincteric injection of botulinum toxin for pain relief in patients with thrombosed~     external haemorrhoids~   "
217086|NCT00717769|"~     The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in~     adult subjects with atopic dermatitis~   "
217087|NCT00717756|"~     This study will determine whether lenalidomide has activity in patients with advanced liver~     cancer that have had growth of their cancer after sorafenib.~   "
217071|NCT00717977|"~     The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a~     large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use~     of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma~     glucose testing. Although the primary outcome in the >= 7.0% cohort is differences in HbA1c~     levels, important secondary outcomes are differences in the percent of glucose sensor values~     either above or below the target glucose range of 70-180 mg/dl and differences in glucose~     variability. Prevention of biochemical hypoglycemia is a particularly important outcome in~     the low HbA1c cohort. Since CGM systems measure interstitial rather than plasma glucose and~     CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely~     useful for comparative purposes to establish a reference range of sensor values in healthy,~     non-diabetic control subjects for this study and other future investigations. The objective~     of this protocol is to establish such reference sensor glucose ranges in each of the 3~     devices being utilized in the JDRF study.~   "
217072|NCT00717951|"~     Docetaxol plus capecitabine regimen is the standard treatment for the~     anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug~     for advanced breast cancer and potential effective drug for triple negative breast cancer.The~     study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine~     and docetaxol+cisplatin.~      The second objective:Assess the safety and QOL.~   "
217073|NCT00717938|"~     The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will~     result in a significant increase of overall survival in patients with small cell lung cancer,~     receiving standard chemotherapy.~   "
217074|NCT00717925|"~     To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544)~     in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).~   "
217075|NCT00717912|"~     The purpose of the study is to determine the glycemic index and the insulinemic index of a~     sweetener syrup~   "
217076|NCT00717899|"~     Haifa bay region is located close to a major industrial zone. The aim of the study is to~     evaluate the health status of school children living in Haifa bay region.The health status~     will be evaluated using health questionnaires and spirometry.~   "
217077|NCT00717886|"~     This study is being done to see if lymph nodes that drain the arm also drain the breast. An~     axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent~     cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are~     removed. They are then examined to see if they have cancer cells. Removing these lymph nodes~     has some side effects. The most common is lymphedema. This is the build-up of fluid in the~     arm. This study will tell us if it may be possible in the future to identify lymph nodes that~     just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future~     patients.~   "
217078|NCT00717873|"~     To compare the outcomes of patients treated with the Vest and conventional chest~     physiotherapy to determine if the Vest provides equivalent therapy~   "
217079|NCT00717860|"~     The purpose of this study is to investigate the safety and efficacy of MK0991 in patients~     with deep-seated mycoses.~   "
217080|NCT00717847|"~     We hypothesize that Epidermal growth factor receptor tyrosine kinase inhibitors modulate~     tumor changes that may be reflected in the alteration of serum proteins.~      Study objectives are:~        -  To establish serum proteomic changes in patients with non-small cell lung cancer (NSCLC)~          receiving erlotinib or gefitinib.~        -  To identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or~          resistance in NSCLC patients with and without EGFR mutations.~        -  To study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with~          serum protein profile.~   "
217081|NCT00717834|"~     The primary objective of this study is to assess the safety and tolerability of the Ross~     River Virus (RRV) Vaccine in a healthy young adult population. Other objectives of this study~     are to assess the immunogenicity of the RRV Vaccine in a healthy young adult population and~     to identify the optimal dose level of the RRV Vaccine in a healthy young adult population.~   "
217082|NCT00717821|"~     This 2 arm study will compare the hemoglobin maintenance with once monthly Mircera~     administration versus epoetin beta or darbepoetin alfa in patients with chronic kidney~     disease on hemodialysis. Patients will be randomized to receive either monthly s.c. or i.v.~     Mircera (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of~     epoetin beta or darbepoetin alfa previously administered), or standard therapy (iv or sc~     epoetin beta once, twice or thrice weekly, or iv or sc darbepoetin alfa once a week or twice~     a week). The anticipated time on study treatment is 3-12 months, and the target sample size~     is 500+ individuals.~   "
217083|NCT00717808|"~     The treatment of rheumatoid arthritis has improved considerably in recent years with the~     understanding that better outcomes can be achieved by optimising the dosage schedule of~     conventional drugs that suppress the inflammatory response in joints. Furthermore, the~     development of protein based drugs that are given parenterally (i.e. by subcutaneous~     injection or intravenous infusion), known as biologics, have given rise to even better~     clinical results. However, despite this over 60% of patients with rheumatoid arthritis can~     still be expected to have an unacceptably high degree of disease activity and the~     prohibitively high cost of biologic therapy has resulted in rationing following NICE review.~     Therefore there is a need for more effective and less costly treatment.~      The proposed study is designed to test potential drug interactions between one such candidate~     oral treatment, tranilast, and the gold standard therapy for rheumatoid arthritis,~     methotrexate, which is given as a once weekly oral, intramuscular or intradermal regimen. The~     drug to be tested, tranilast, an analogue of a naturally occurring molecule that regulates~     inflammatory responses, is currently used in the treatment of allergic inflammation and has~     recently been shown to be effective in an animal model of multiple sclerosis. Tranilast is an~     analogue of a naturally tryptophan metabolite. Laboratory studies of cell biology indicate~     that this molecule inhibits a number of key inflammatory pathways and the function of white~     blood cells that play a critical role in the inflammatory features of rheumatoid arthritis.~     The aim of this study is to assess whether tranilast may be useful for the treatment of RA.~     In an animal model of rheumatoid arthritis, initial assessment showed that prophylactic~     administration of tranilast interfered with the development of disease. Therapeutically, in~     an animal model of arthritis, tranilast was very effective, and reduced all aspects of the~     disease, including joint swelling, clinical score, and histological damage in a~     dose−dependent fashion, and reduced pain. This degree of benefit compares well with~     therapeutics that have been highly successful in humans, such as anti−TNF therapy.~     Furthermore studies at the Kennedy Institute of Rheumatology Division, Imperial College~     suggest that tranilast has a greater analgesic effect than the potent steroid dexamethasone~     at effective anti−inflammatory doses~   "
217084|NCT00717795|"~     The purpose of this study is to learn how many lung cancer survivors will agree to a physical~     activity program. We also want to know if lung cancer survivors benefit from this program.~     This information will help us to develop our services for lung cancer survivors.~   "
217180|NCT00716547|"~     The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg~     and 100 mg ketoprofen in Diractin®.~   "
217089|NCT00717730|"~     Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or~     without simultaneous administration of vitamin B12 reduces the rates of acute lower~     respiratory tract infections (ALRI), clinical pneumonia and diarrhea.~      Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of~     folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a~     low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months~     will be identified through a survey. Eligible and willing Children aged 6-30 months will be~     randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by~     the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child~     weight and length taken. The baseline blood samples will be collected. The supplements will~     be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by~     field workers.~   "
217090|NCT00717717|"~     The PACT Study (Physical Activity after Cancer Treatment) is a unique study within the field~     of cancer rehabilitation in Denmark. It differs from other studies mainly due to the~     intervention itself. A combination of physiological, health educational and therapeutic~     elements will be tested. These components are incorporated into a one-year training program~     for mixed groups (i.e. men + women, with varying cancer diagnoses) to encourage them to~     enhance their well.-being and quality of life. The overall aim of this approach is to place~     increased focus on the treated cancer patient's introduction to and exploitation of both~     physiological and psychosocial yields through physical exercise. Whether or not the study~     results bear a positive effect, they are expected to support new knowledge in rehabilitation~     for cancer survivors.~   "
217091|NCT00717704|"~     Patients are being asked to take part in this study because they have been diagnosed with an~     advanced solid tumor that is not responding to standard treatments. This study will find the~     highest dose of ixabepilone and dasatinib in combination that can be given without causing~     severe side effects.~      Both ixabepilone and dasatinib have individually been tested in many (several thousand)~     patients, however the combination of the two drugs has not yet been tested in humans.~      All patients who will take part in this study will receive combined drug therapy of dasatinib~     and ixabepilone. Dasatinib is a pill that is taken by mouth. Ixabepilone is a medicine that~     will be given by vein (IV).~      All participants will receive ixabepilone by vein once every three weeks as well as dasatinib~     by mouth once daily.~   "
217092|NCT00717691|"~     The purpose of this study is to regain range of motion of the great toe with dynamic~     splinting which will help reduce great toe's pain and swelling.~   "
217093|NCT00717678|"~     The purpose of this study is to compare the efficacy and safety of Prograf extended~     release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.~   "
217094|NCT00717665|"~     This study is an open randomized controlled trial of 12-month duration, which compares the~     use of a home blood pressure (BP) tele-management system to the usual approach of home BP~     monitoring in older diabetic patients with uncontrolled systolic hypertension. The purpose of~     this study is to determine whether home blood pressure tele-management system will markedly~     improve blood pressure control in a primary care setting.~   "
217095|NCT00717652|"~     The objective of this study is evaluating the clinical activity of the association (tretinoin~     + arbutin + triamcinolone) in the treatment of epidermal melasma.~   "
217096|NCT00717639|"~     This study aims at investigating the diagnostic accuracy of magnetic resonance angiography~     using the contrast agent Vasovist® in the detection of relevant vascular narrowing of the~     lower extremity. Patients who have been scheduled for intra-arterial conventional angiography~     are eligible for this trial.~   "
217097|NCT00717626|"~     The primary objective of this study is to test the feasibility of a large-scale clinical~     trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy~     outcomes so that we can better plan a large-scale study; we will estimate the effect size and~     variability of effect and resource utilization of once-daily prophylaxis to allow us to set a~     sample size for a definitive trial.~   "
217098|NCT00717613|"~     This study includes an interview with men who have selected watchful waiting or active~     surveillance for their localized prostate cancer, in lieu of active treatment (such as~     surgery or radiation). We hope to understand the educational and support needs of men on~     surveillance so that we can develop a new intervention that will improve quality of life for~     such men.~   "
217099|NCT00717600|"~     Many children who catheterize their bladders because of spina bifida or other neurologic~     disorders have bacteriuria. This can lead to urinary tract infections by bacteria from the~     gut which colonize the vagina and are carried into the bladder during catheter passage. We~     seek to test whether oral administration of probiotic bacteria can displace these~     vagina-derived uropathogens and reduce or prevent bacteriuria in girls with spina bifida who~     empty their bladders through catheterization.~   "
217100|NCT00717587|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. Giving it after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well sunitinib works when given before and after~     surgery in treating patients with stage IV kidney cancer.~   "
217101|NCT00717574|"~     The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or~     propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant~     level of surgical stimulus~   "
217102|NCT00717561|"~     The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is~     as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by~     oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired~     pneumonia.~   "
217103|NCT00717548|"~     The purpose of this study is to perform an evaluation of a trauma-focused short-term~     intervention (Narrative Exposure Therapy; Schauer, M., Neuner, F. & Elbert, T.) on a variety~     of clinical outcome measures (PTSD, Depression, Somatic Complaints, Dissociation) in women~     after sexual exploitation and women trafficking.~   "
217181|NCT00716534|"~     This study is designed to determine the clinical efficacy and toxicity of ABT-869 in~     combination with carboplatin and paclitaxel in the treatment of subjects with advanced or~     metastatic NSCLC.~   "
217104|NCT00717535|"~     RATIONALE: Studying umbilical cord blood in the laboratory and gathering information about~     current and previous pregnancies from African-American umbilical cord blood donors may help~     doctors learn more about the umbilical cord blood of these donors.~      PURPOSE: This clinical trial is looking at umbilical cord blood from African-American donors.~   "
217105|NCT00717522|"~     The purpose of the study is to determine the safety and efficacy of single agent CC-4047~     (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are~     refractory to prior anticancer therapy.~   "
217106|NCT00717509|"~     We are going to investigate the association of multiple genetic polymorphisms with the~     metabolic side effects in patients with schizophrenia taking clozapine.~   "
217107|NCT00717496|"~     This randomized controlled trial will evaluate an innovative telephone-based breastfeeding~     education and promotion intervention that will be implemented in a low-income, predominately~     Latina population. The trial will assess the impact of the intervention on duration of~     breastfeeding and exclusivity of breastfeeding at 1, 2, 3 and 6 months post-partum.~   "
217108|NCT00717483|"~     The landmark study Diabetes Control and Complication Trial (DCCT) clearly showed that~     intensive insulin management delays the onset and progression of longterm complications in~     adolescents with type 1 diabetes mellitus (T1DM). The same clinic trial also showed increased~     rate of severe hypoglycemia which required assistance. The risks of severe hypoglycemia,~     defined as loss of consciousness or seizure associated with hypoglycemia, include lower~     HbA1C, younger age, higher insulin dose, male sex, lower parental socioeconomic status,~     non-Hispanic white ethnicity, longer duration of disease, the presence of psychiatric~     disorders, and underinsurance.~      The purpose of this protocol is to explore the relationship between hypoglycemic seizures and~     BMI.~   "
217109|NCT00717470|"~     To compare how well the new formulation of Tacrolimus® used once daily, in combination with~     other drugs helps prevent the rejection of a new kidney after transplantation compared to the~     twice daily dose of Tacrolimus~   "
217110|NCT00717457|"~     This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared~     with exenatide in patients with type 2 diabetes mellitus inadequately controlled with~     metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive~     taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly)~     or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in~     a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either~     alone or in combination. The anticipated time on study treatment is 3+ years, and the target~     sample size is >500 individuals.~   "
217111|NCT00717444|"~     In this Stage 1 therapy development project, we plan to develop, formalize, and derive effect~     size estimates of a contingency management (CM) therapy that focuses on improving health,~     especially as related to increasing low intensity physical activities, such as walking,~     resistance training, and stretching. The Healthy Activities for Prize Incentives (HAPI)~     intervention will be targeted toward and tested within HIV-positive substance abusers who~     attend HIV drop-in centers. After initial therapy development in a Stage 1a pilot project~     with 9 patients, the therapy manuals and materials will be adapted and refined. In a Stage 1b~     controlled trial, we will recruit and randomize 70 substance abusing HIV-positive patients to~     (a) HAPI plus 12-step facilitation therapy or (b) contingency management for abstinence plus~     12-step facilitation therapy. Each intervention will consist of one weekly individual therapy~     session for 16 weeks. All participants will provide urine and breath specimens twice weekly~     that will be tested for opioids, cocaine, methamphetamine, marijuana and alcohol. Patients in~     both conditions will earn the chance to win prizes for submitting drug-negative specimens,~     and those randomized to the HAPI condition will also earn the chance to win prizes for~     engaging in healthy activities. Physical activity levels, drug use, psychological symptoms,~     and subjective and objective indicators of health (body mass index, waist circumference,~     blood pressure, viral load) will be measured pre-treatment and at months 2 and 4~     (post-treatment), as well as at a 7-month (3 months after treatment) follow-up evaluation.~     Compared to those receiving 12-step facilitation with contingency management for abstinence,~     we expect that those in the HAPI condition will participate in more physical activities,~     decrease drug use to a greater extent, evidence reduced depression, and show trends toward~     improvements in health indices. If effect sizes in at least the small to medium range are~     noted across all domains, we will consider the therapy appropriate for further evaluation in~     a Stage 2 therapy development study.~   "
217112|NCT00717431|"~     The primary goal is to determine whether hippocampal electrical stimulation (HS) is safe and~     more effective than simply implanting an electrode in the hippocampus without electrical~     stimulation (HI), in patients with mesial temporal lobe epilepsy (MTLE). This will be~     assessed by the rate of complex partial seizures per person-month over 6 months of follow-up~     in HS vs. HI. There are two treatment arms: 1) Hippocampal Electrode Implantation with~     Stimulation (HS). 2) Hippocampal Electrode Implantation without stimulation (HI). The~     investigators expect to demonstrate that HS is safe and superior to HI in controlling~     seizures in patients with MTLE.~   "
217113|NCT00717418|"~     This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other~     non-prescription treatments in patients with dry eye disease. Patient and physician~     assessments completed at baseline, at each follow-up visit (follow-up visits are variable as~     per physician discretion) and at final follow-up visit.~   "
217114|NCT00717405|"~     This single arm study will assess the efficacy and safety of preoperative treatment with~     Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory~     HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of~     pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is~     3-12 months, and the target sample size is <100 individuals.~   "
217115|NCT00717392|"~     Hippotherapy is every program of horseback riding meant to treat people with physiological,~     mental, social, cognitive or behavioral problems. The purpose of the current research is to~     evaluate the efficacy of hippotherapy for children with developmental disabilities. The~     hypothesis is that children with developmental disabilities who are treated with hippotherapy~     will show better outcomes than children with the same problems who are not treated with~     hippotherapy.~   "
217116|NCT00717379|"~     To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two~     regimens of steroid in an adult kidney transplanted population.~   "
217117|NCT00717366|"~     This sequential study will assess the efficacy and safety of multiple doses of intravenous~     (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum~     starting dose for maintenance treatment of anemia in children with chronic kidney disease on~     hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin~     alfa during the screening period, after which they will receive IV MIRCERA monthly, at a~     starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on~     the response achieved, another group may be selected to receive a higher or a lower dose.~   "
217118|NCT00717353|"~     Primary~        1. To determine the presence and frequency of novel and known UGT1A6 and UGT2B7~          polymorphisms in healthy Chinese, Malay and Indian subjects.~        2. To determine the presence and frequency of novel and known UGT1A6 and UGT2B7~          polymorphisms in Chinese lung cancer patients with squamous cell and adenocarcinoma~          subtype.~        3. To analyze the functional variations in UGT1A6 and UGT2B7 polymorphisms.~      Secondary~      1 To study the correlation of UGT1A6 and UGT2B7 polymorphisms with lung cancer type.~   "
217119|NCT00717340|"~     This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety,~     tolerability, maximum tolerated dose, and overall response rate of tivozanib (AV-951) and~     paclitaxel in a breast cancer.~   "
217120|NCT00717327|"~     Do adolescents know about their medications?~   "
217121|NCT00717314|"~     This 2 arm study will compare the efficacy and safety of switching to CellCept combined with~     different regimens of reduced calcineurin inhibitors (CNI) in patients with liver~     transplants. Patients currently receiving CNI treatment will be randomized into one of 2~     groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or~     2) CellCept 2.0g/day po bid + >=75% reduction of CNI from baseline. The anticipated time on~     study treatment is 1 year, and the target sample size is <100 individuals.~   "
217122|NCT00717301|"~     The purpose of the study is to determine if a specific blood protein, S-100B, can help~     predict who will have a traumatic abnormality on head CT scan after a concussion. We will~     compare the levels of this protein in the subject's blood to the initial head CT scan and to~     how the subject is feeling one month after injury. We hope that the information we collect in~     this trial will help us determine who needs a head CT scan after a concussion and who may be~     more likely to have trouble recovering from a concussion.~   "
217123|NCT00717288|"~     In this study we will determine the proper method for transitioning patients from a~     continuous insulin infusion to periodic injections of a newer long-acting insulin called~     detemir (Levemir).~   "
217124|NCT00717275|"~     The purpose of this study is to determine if administering temozolomide after completion of~     stereotactic radiosurgery helps control existing brain metastases and prevents the~     developement of new brain metastases.~   "
217125|NCT00717262|"~     The purpose of this study is to evaluate the safety, activity and pharmacokinetics of a new~     investigational drug (HQK-1001) in healthy human volunteers. This study will also evaluate if~     there are differences in these parameters when HQK-1001 is administered in a fed versus a~     fasted state.~   "
217126|NCT00717249|"~     This study compares the performance of an investigational contact lens to a currently~     marketed lens.~   "
217127|NCT00717236|"~     This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab~     pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.~   "
217128|NCT00717223|"~     The purpose of this study is to see if a patient's ability (and/ or parent) to read, write,~     and do basic math problems affects blood sugar control in children with type 1 diabetes~     mellitus.~   "
217129|NCT00717210|"~     Background: The optimal treatment of anaplastic gliomas is controversial. Standard of care in~     most centers is still radiotherapy. This phase III study compared the efficacy and safety of~     radiotherapy vs chemotherapy in patients (pts) with newly-diagnosed, supratentorial gliomas~     of WHO grade III.~      Methods: Pts were randomized 2:1:1 between June 1999 and February 2005 in 34 German centers~     to receive (i) a 6-week course of radiotherapy (1,8-2 Gy fractions, total dose 54-60 Gy) or~     (ii) four 6-week cycles of CCNU at 110 mg mg/m2 on day 1, vincristine at 2 mg on days 8 and~     29 and procarbazine at 60 mg/m2 on days 8-21 or eight 4-week cycles of 200 mg/m2 temozolomide~     on days 1-5. Treatment was stopped prematurely at disease progression or occurrence of~     unacceptable toxicity. At this time or at disease progression, treatment in the radiotherapy~     group was continued with one of the chemotherapies (1:1 randomization) and with radiotherapy~     in both chemotherapy groups. The primary endpoint was time-to-treatment-failure (TTF) defined~     as progression after radiotherapy and one chemotherapy in either sequence, or any time before~     if further therapy could not be employed. Assuming a 50% improvement in TTF of starting with~     chemotherapy, 318 pts were to be enrolled to provide 80% power to achieve statistical~     significance at a one-sided level of 0.05.~   "
217130|NCT00717197|"~     The purpose of this study is to determine if capecitabine is effective in the treatment of~     high grade gliomas that have returned after completing treatment.~   "
217131|NCT00717184|"~     1. To demonstrate the feasibility of leukapheresis and ex vivo activation of autologous NK~          cells in patients with metastatic NPC~        2. To demonstrate the safety of low dose systemic IL-2 in combination with escalating doses~          of autologous Ex Vivo Activated NK cells in patients with metastatic NPC~        3. To assess immune measurements such as quantitation of regulatory T cells, EBV specific T~          cells, serum cytokine levels, and NK cell function after treatment with IL-2 and~          autologous Ex Vivo Activated NK cells~   "
217132|NCT00717171|"~     The purpose of this study is to determine whether a functional electrical stimulation device,~     the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior~     cruciate ligament repair.~   "
217133|NCT00717158|"~     The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of~     life outcomes of a nutrition intervention involving lifestyle case management and medical~     nutrition therapy by a registered dietitian compared to usual medical care in obese persons~     with type 2 diabetes. The intervention is aimed at moderate weight loss (> 5-10%),~     improvement in diet quality and an increase in physical activity.~   "
217134|NCT00717145|"~     Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will~     consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3,~     and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration~     separating each treatment period), and exit procedures.~   "
217135|NCT00717132|"~     To determine the cost effectiveness of treating the child alone and parent alone to~     traditional family-based method of obesity treatment. It is hypothesized that a family-based~     approach will be more cost effective, and will support the savings and effectiveness of~     treating multiple family members together.~   "
217136|NCT00717119|"~     Retrospective cohort study to evaluate the effect of the association of PPIs with NSAIDs in~     work leave time.~   "
217141|NCT00717054|"~     The purpose of this study is to compare the incidence of nausea, vomiting, need for rescue~     medication, prolonged PACU time, and unplanned hospital admission in patients with high risk~     for post-operative nausea and vomiting (PONV) treated with oral aprepitant with or without~     transdermal scopolamine preoperatively.~   "
217142|NCT00717041|"~     Many older adults have undetected health problems and lack basic prevention measures. Failure~     to identify and treat these conditions can lead to unnecessary morbidity and mortality and a~     decreased quality of life. Traditional screening and intervention programs, usually based in~     primary care providers' offices, have been insufficient, particularly in medically~     underserved populations. Alternate sites for screening and intervention have begun to receive~     attention and may hold promise.~      The emergency department (ED) is the entry point for access to medical and social services~     for many patients and has the potential to serve as a site to identify older adults with~     unmet needs. However, we do not know the prevalence of depression and cognitive impairment~     and how they differ by mode of arrival of the patient to the ED. Second, a question remains~     as to the validity of screening patients during an acute illness. Upon completion, this study~     will describe the epidemiology of the population of older adults presenting to the ED.~   "
217143|NCT00717028|"~     The investigators objective is to describe functional endoscopic evaluation of swallowing~     findings in children with cerebral palsy.~   "
217144|NCT00717015|"~     We hypothesized that subjects with CYP2D6*10 alleles may have a lower steady state levels of~     endoxifen due to reduced conversion of tamoxifen to endoxifen.~      Primary objectives:~        -  To determine the steady state pharmacokinetics of tamoxifen and its metabolites~        -  To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of~          tamoxifen and its metabolites in hormone receptor positive women who are taking~          tamoxifen as adjuvant treatment for breast cancer.~   "
217145|NCT00717002|"~     The overall objective of the study is to assess the feasibility of the use of blood for the~     detection of EGFR mutations in patients with non-small cell lung cancer (NSCLC)~      Specific aims are:~        1. To assess the use of immuno-separation techniques to enrich the tumor cell population in~          the blood of NSCLC patients.~        2. To assess the use of denaturing high performance liquid chromatography (DHPLC) assay for~          the detection of EGFR mutations in the blood of NSCLC patients.~   "
217146|NCT00716989|"~     The goal of the vaccination is to induce humoral (antibody) and intracellular (T lymphocyte)~     responses. Various data show that intradermal vaccination is more efficient than~     intramuscular vaccination: the humoral response is statistically better after intradermic~     vaccination, compared to intramuscular vaccination, even in target populations such as older~     subjects or immunosuppressed patients~   "
217147|NCT00716976|"~     RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving~     cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than~     no additional treatment in preventing hearing loss.~      PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it~     works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed~     germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other~     malignancy.~   "
217148|NCT00716963|"~     The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded,~     randomized, crossover study in which single doses of placebo, will be compared to Fluticasone~     propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen~     challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from~     post-allergen peak)~   "
217149|NCT00716950|"~     Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events~     of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but~     often this result can be obtained with a combination therapy. Some evidences demonstrate~     sartans and calcium channels blockers can be very useful and safe, but it is also important~     to verify which association can give side effects or give some pharmacokinetic interactions~     that can negatively influence the clinical combination efficacy.~   "
217150|NCT00716937|"~     Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis~     Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Healing by Secondary~     Intention (EHSI) Technique in Imam Khomeini Hospital from 2008 to 2011~   "
217151|NCT00716924|"~     Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24~     hours prior to PCI produce a greater decrease of periprocedural release of biochemical~     markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg~     loading dose, given ≥ 6 and ≤ 24 hours prior to PCI or 600 mg loading dose of clopidogrel,~     administered immediately (≤ 45 minutes) before PCI.~   "
217152|NCT00716911|"~     RATIONALE: Tests that measure certain changes in blood in patients at high risk of~     cytomegalovirus infection may help doctors learn more about predicting cytomegalovirus~     infection after donor stem cell transplant.~      PURPOSE: This clinical trial is studying tests that measure changes in the blood in patients~     at high risk of cytomegalovirus infection after undergoing donor bone marrow transplant or~     peripheral stem cell transplant.~   "
217153|NCT00716898|"~     The purpose of the study is to determine the Pharmacokinetics of Low Molecular Weight Heparin~     (LMWH) in Cancer patients, and compare it to the Pharmacokinetics of LMWH in Patients without~     cancer. We also intend to detect any correlation between heparanase blood and urine levels~     and the Pharmacokinetics of LMWH.~   "
217154|NCT00716885|"~     1. To assess whether a correlation exist between the degree of pulmonary clearance of free~          radical positive white bloodcells and platelets and the degree of pulmonary congestion~          in congestive heart failure (CHF) patients~        2. To asses whether cardiac resynchronization therapy improves pulmonary clearance of free~          radical positive white blood cells and platelets in CHF patients by alleviating~          pulmonary congestion~        3. Interaction of oxidative stress with circulating endothelial progenitor cells (EPCs) and~          presence of apoptotic endothelial (progenitor) cells~   "
217155|NCT00716872|"~     The purpose of this study is to determine whether an Internet-based program, Sleep Healthy~     Using the Internet (SHUTi, or Shut-Eye), can help to improve the sleep of people who are in~     remission from cancer and experiencing symptoms of insomnia.~   "
217156|NCT00716859|"~     To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and~     timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are~     diagnosed with glaucoma.~   "
217158|NCT00716833|"~     This randomised placebo controlled double-blinded bicentre study (phase III) was designed to~     evaluate the preemptive and postoperative analgetic impact of etoricoxibe in open abdominal~     and thoracic surgery. Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme~     (COX-2).~      Therefore 120 patients (ASA-risk 1-2) with upcoming abdominal or thoracic surgery should be~     included into this study. Patients are randomly allocated to either the preemptive or the~     postoperative Etoricoxibe group. These two groups are divided each into two arms. Preemptive~     group patients get Etoricoxibe either twice (before and after surgery) or just a single~     preoperative dose. Postoperative group patients get placebo before surgery and either a drug~     application or a placebo again after surgery (so called 2x2 factorial study design).~      Cumulative use of morphine as assessed within first 48 hours after surgery is the primary~     trial outcome indicating the analgesic potency of Etoricoxibe.~      In addition, changes in patients level of sensibilisation will be measured with help of~     quantitative sensory testing (a standardised procedure) before and after surgery (secondary~     outcome). In addition pharmacogenetic testing will provide information about genetic~     aberrations (so called polymorphisms) of the patients enzymes that should be compared to the~     individual reaction regarding Etoricoxibe.~      The results will give hint about the analgesic impact of etoricoxibe in acute postoperative~     pain. There will be findings for preemptive analgesia and nerval processes. All this could~     lead to an improvement of postoperative pain relief while administrating preemptively a COX-2~     selective inhibitor before surgery.~   "
217159|NCT00716820|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
217160|NCT00716807|"~     Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or~     patients with burning mouth syndrome participate in this study. The aim of the study is to~     compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered~     with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to~     determine if there are sex differences in these two drug regimens. Drugs will be administered~     with single-use intranasal spray devices. All participants will receive two sprays (one spray~     per nostril). One of the two sprays will be nalbuphine (5 mg). The other spray will be~     naloxone in half the participants and placebo in the other half.~   "
217161|NCT00716794|"~     This is a phase I/II, open-label, dose escalation study of HE3235 administered orally to~     patients with advanced prostate cancer who have failed hormone therapy and at least one~     taxane based chemotherapy regimen.~   "
217162|NCT00716781|"~     Intrapartum antibiotic prophylaxis has greatly decreased but not abolished early-onset~     neonatal sepsis caused by GBS. According to current recommendations, the evaluation of~     infants at risk for GBS sepsis should include a complete blood count (CBC), WBC differential,~     a blood culture (BC) and a period of observation. The usefulness of CBC and BC in the~     evaluation process is not firmly established.~   "
217163|NCT00716768|"~     Laparoscopic techniques have been applied widely to the management of various common~     pediatric surgical diseases. Current evidence lacks sufficient quality to justify the~     widespread adoption of the laparoscopic approach to the repair of inguinal hernias within~     children. It is important to critically evaluate the efficiency and the potential risks of~     these new techniques before they can supplant open techniques as the treatment modality of~     choice. Numerous large case series of laparoscopic inguinal hernia repair have been reported~     with average length of stay, complication rates, recurrence rates and pain management scores~     that mirror those of open inguinal hernia repair. Only one randomized controlled trial has~     been performed to compare the open versus laparoscopic technique which has not provided~     answers regarding the potential benefits on young infants. Benefits of an open approach in~     children includes a shorter operative time, while the laparoscopic procedure is associated~     with less pain and a better cosmetic result.~      This study will compare open versus laparoscopic repairs of inguinal hernias. The primary~     outcome variable will be total dose of acetaminophen administered postoperatively for pain~     management. Secondary outcome variables include 1) Incidence of intraoperative complications~     such as compromise of testicular vessels, perforation of abdominal viscera; 2) Short-term~     outcomes such as operative time, rate of conversion from open to laparoscopic procedure,~     requirement for reoperation within 30 days, wound infection, acute hydroceles and~     post-operative length of stay; 3) Long-term outcomes such as recurrent inguinal hernia,~     testicular atrophy and; 4) Cost of hospitalization will be compared between the open and~     laparoscopic groups.~      Comparisons will be made in two groups of patients- patients with 1) unilateral hernias and~     2) bilateral hernias and will last for 2 years. 102 patients in the unilateral arm and 50~     patients in the bilateral arm will be randomized to each treatment group and each subject~     will be followed for up to 12 months following the surgical intervention. Two study~     evaluations by telephone (in addition to a single outpatient clinic visit already required as~     part of standard post-operative care) will be required of each research subject and his/her~     parent/guardian. The telephone evaluations will occur at 3 and 12 months following surgery.~     The standard post-operative clinic visit is scheduled at 2 weeks following surgery.~   "
217164|NCT00716755|"~     Since side effects of antipsychotics, dopamine D2 receptor blockers, frequently occur in~     older patients with schizophrenia and the risk is dose dependent, clinical guidelines~     universally advocate the use of lower doses. However, there is no report to test this dosing~     guideline with measurements of D2 receptor blockade caused by antipsychotics. In this study,~     dopamine D2 receptor occupancy will be measured, using Positron Emission Tomography (PET), in~     40 patients aged 50 and older with schizophrenia-spectrum disorders before and after a~     gradual 40 % dose reduction of antipsychotics that was safely achieved in the past study~     while setting a target dose still above the lower limit of the dose range recommended in~     clinical guidelines for older patients. Our goal is to relate changes in clinical outcome,~     including subjective and objective clinical ratings, to dopamine D2 receptor occupancy, and~     compare these results with the data for younger patients in the literature.~   "
217165|NCT00716742|"~     To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal~     clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each~     follow-up visit (follow-up visits are variable as per physician discretion) and at final~     follow-up visit.~   "
217166|NCT00716729|"~     The aim of this study is to develop an evaluative questionnaire, to evaluate patients with~     hip and groin disability, and a strength measurement for the hip, for patients with hip and~     groin disability.~      Both measurement instrument are aimed for evaluating the natural course and different~     treatment modalities in patients with hip and groin disability.~   "
217167|NCT00716716|"~     The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to~     100 IU/kg.~   "
217182|NCT00716521|"~     This study will assess the feasibility of conducting sleep studies in a clinical research~     unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy~     technologies will be compared for evaluating sleep stages and sleep architecture.~   "
217183|NCT00716508|"~     We will compare two groups for acute patella tendon repair: one treated with surgical anchors~     and the second, with transpatellar tunnels.~   "
217168|NCT00716703|"~     Computed tomography (CT) scan using intravenous contrast (CT IV) as the sole type of contrast~     material, was studied as one method of evaluating children with suspected appendicitis. We~     felt that this technique could provide physicians with a faster and better-tolerated~     alternative to CT imaging which involves patients drinking oral contrast or needing rectal~     contrast administered.~      SPECIFIC AIMS~        1. To test an imaging protocol using CT IV for the evaluation of suspected appendicitis in~          children in the setting of a pediatric emergency department (ED).~        2. To determine test performance characteristics (specificity, sensitivity and diagnostic~          accuracy) of CT IV in detecting appendicitis in children.~   "
217169|NCT00716690|"~     The proposed research focuses on the development of innovative protocol of mismatched stem~     cell transplantation with combined 2 different haplo stem cell transplantation (SCT) donors~     which are mismatched to the recipient (and preferably to each other), in a patient in need~     for SCT, lacking an HLA match related or an unrelated donor. This innovative protocol named~     multi donor stem cell transplantation (MDT) is designed to facilitate engraftment even when~     reduced intensity conditioning or a low cell dose are used, improve the graft vs. leukemia~     (GVL) effect and enhance immune reconstitution (using quantitative and qualitative~     parameters).~   "
217170|NCT00716677|"~     We plan to use the Life Shirt to record tidal volume, respiratory rate and breathing pattern~     over a 6 hour period in patients admitted with difficult asthma. The Life Shirt will also be~     used to collect the same data over the same time period in a group of healthy controls. This~     data will then be correlated with the assessment of the supervising consultant as to whether~     the patient has any element of dysfunctional breathing contributing to their symptoms. It is~     hoped that the data obtained may in future be used to offer treatment to those patients with~     dysfunctional breathing.~   "
217171|NCT00716664|"~     The pilot study aims to evaluate the effects of a treatment series of gentle joint and muscle~     movements (in addition to normal optimal care)on lung function, exercise capacity and posture~     in stable adults with cystic fibrosis.~   "
217172|NCT00716651|"~     Churg-Strauss syndrome is a rare type of systemic vasculitis which occurs almost exclusively~     in patients with asthma and which is characterized by prominent blood and tissue~     eosinophilia. The disease has a chronic smoldering course with a permanent need for medium to~     high corticosteroid doses. Available unselective immunosuppressive agents are often~     insufficient to reduce corticosteroid doses, to induce complete remission and to protect~     patients from disease flares which occur in more than 50 % of cases.~      Interleukin-5 is the most potent cytokine regulating the production of eosinophil~     granulocytes which are the major effector cells in Churg-Strauss syndrome. Recently, an~     increased production of interleukin-5 was demonstrated in Churg-Strauss syndrome. Mepolizumab~     is a monoclonal IgG antibody targeting interleukin-5 and is effective in the treatment of the~     HES. The hypothesis of this study is, that mepolizumab will induce remission and allow for~     steroid reduction.~   "
217173|NCT00716638|"~     This study will evaluate the effectiveness of trauma-focused cognitive behaviour therapy~     (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of~     trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly~     assigned to TF-CBT or EMDR. Follow-up assessments will be conducted at 3 and 12 months~     post-treatment. In addition to comparing the efficacy of the two protocols, an additional~     focus will lie on identifying predictors for treatment outcome.~   "
217174|NCT00716625|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
217175|NCT00716612|"~     The purpose of this study is to determine whether Coenzyme Q 10 supplementation will decrease~     the rate of Muscle Pain in patients with previous statin related Muscle Pain.~   "
217176|NCT00716599|"~     Malaria remains one of the most devastating infectious diseases in the world. Despite the~     potential for serious adverse outcomes with each episode of malaria, most cases in endemic~     areas are diagnosed on clinical grounds alone. Even the simple technique of light microscopy,~     the gold standard for malaria diagnosis, is inaccessible to most individuals in resource-poor~     malarious areas. New diagnostic methods that are practical for limited health-care settings~     are urgently needed. Immunochromatographic rapid diagnostic tests (RDTs) for malaria are easy~     to use, require little infrastructure or expertise, show good accuracy, and are increasingly~     advocated for routine use in malaria-endemic areas. A major challenge now is to implement~     RDTs effectively in typical African clinical settings. We plan to evaluate the clinical~     effectiveness and safety of a training curriculum incorporating RDT use in peripheral~     government health centers in Uganda. Results from this study will provide evidence for~     scale-up of RDT implementation in Uganda, as planned by the Uganda Ministry of Health from~     mid-2008, as well as in other sub-Saharan African countries.~      The aim of this study is to evaluate the clinical effectiveness and safety of a basic~     training program incorporating RDTs, as compared with standard-of-care presumptive treatment,~     for the management of patients who present with suspected malaria at peripheral health~     centers in Uganda. Our hypothesis is that training in fever case management and RDT use will~     allow health center staff to reduce unnecessary antimalarial prescriptions without~     compromising patient outcomes, compared with the current practice of presumptive antimalarial~     therapy for all febrile patients.~   "
217177|NCT00716586|"~     Seven patients with X-linked retinoschisis were treated with dorzolamide and the response to~     this treatment was monitored using OCT. These patients were also tested for the causative~     gene mutation and the resultant mechanism of functional loss of retinoschisin. It was~     observed that a response to dorzolamide may be seen irrespective of the mechanism that leads~     to decrease in function of retinoschisin.~   "
217178|NCT00716573|"~     After transplantation, renal impairment, incidence and progression of atherosclerosis lead to~     modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI~     and/or introduction of everolimus. The risk or benefits of these strategies were not clearly~     evaluated by specific clinical trials.~      This study is specifically designed for evaluating the impact of everolimus introduction,~     with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and~     clinical outcomes, specially on :~        -  Renal function improvement~        -  Vasculopathy and major cardiac event reduction~        -  Maintenance of immunosuppressive efficacy~   "
217184|NCT00716495|"~     In this open-label study of patients with advanced melanoma 20 evaluable patients will be~     recruited.~      The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a~     mixture (1:1 ratio) of two therapeutic gene modified human melanoma cell lines, referred to~     as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative~      Patients will receive treatment for up to 26 weeks. Progression at any time point requiring~     systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal~     of this patient from the study.~      The dose chosen is 5 x 107 viable cells/dose.~   "
217185|NCT00716482|"~     Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast~     ultrasound examination provides useful information for the radiologist when imaging lesions~     in the breast, as compared to conventional grayscale ultrasound alone.~   "
217186|NCT00716469|"~     Plexiform neurofibromas (PN) represent one of the most significant complications of NF1. They~     are a significant cause of morbidity in neurofibromatosis type 1 (NF1) by causing pain,~     impaired function, and disfigurement. They may become life-threatening through mechanical~     compression of vital organs such as the trachea, great vessels, or spinal cord, and may~     significantly interfere with normal function when located in the extremities or orbit. The~     only effective therapy for PN is total surgical excision. However, due to local infiltration~     of normal tissue, gross total resection is usually not feasible, and often PN are completely~     unresectable due to their location, size, and multiplicity. To date, other therapeutic~     modalities, including radiotherapy and chemotherapy, have not shown efficacy in PN.~      In the present study, local photodynamic therapy will be investigated. Photodynamic therapy~     (PDT) utilizes a drug, called a photosensitizer or photosensitizing agent, and a particular~     type of light. When photosensitizers are exposed to a specific wavelength of light, they~     produce a form of oxygen that kills nearby cells. PDT is expected to result in treatment~     response with shrinkage of tumor. The main purpose of the study is to determine the maximum~     amount of light that can be safely used with LS11 for PDT in children with plexiform~     neurofibromas.~   "
217187|NCT00716456|"~     The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that~     initially became smaller after taking erlotinib and then started to get bigger despite~     continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug~     administration for treatment of head and neck and colon cancer. The goal of the phase I~     portion of this trial is to find out the highest dose of cetuximab that can be taken together~     with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer~     when given with erlotinib.~      The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that~     initially became smaller after taking erlotinib or gefitinib and then started to get bigger~     despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug~     administration for treatment of head and neck and colon cancer. The goal of this phase is to~     determine if cetuximab given with erlotinib causes lung cancers to shrink in size.~   "
217188|NCT00716443|"~     Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane®~     injections for the correction of nasolabial folds.~   "
217189|NCT00716430|"~     The main hypothesis to be tested is that the use of a quality improvement programme will lead~     to measurable improvements in the management of care and use of evidence based treatments for~     patients presenting to hospital with non-ST elevation acute coronary syndromes.~   "
217190|NCT00716417|"~     Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone~     chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.~      The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.~   "
217191|NCT00716404|"~     This is a prospective, observational, multi-center study with consecutive enrollment. Up to~     1,000 patients will be enrolled. The objective of this post-marketing surveillance study is~     to collect clinical usage patterns of the Benephit Infusion Systems. As a result, FlowMedica~     will be able to:~        1. Better understand and quantify usage patterns including patient characteristics,~          adjunctive procedures, and infusion agents.~        2. Collect user-interface information and overall customer satisfaction.~        3. Monitor post-marketing device performance.~   "
217192|NCT00716391|"~     An Open Label Randomized, Multi-Centre Phase III Trial of TPF Chemotherapy Plus Concomitant~     Treatment With Cisplatin and Conventional Radiotherapy Versus TPF Chemotherapy Plus~     Concomitant Cetuximab and Conventional Radiotherapy in Locally Advanced, Unresectable Head~     and Neck Cancer.~   "
217193|NCT00716378|"~     This study, conducted at the University of Massachusetts at Amherst, will examine how male~     teenage driving performance varies in the presence or absence of male teenage passengers. It~     will explore what information teen drivers and their passengers use when making decisions~     that affect their performance on the road.~      Male drivers under 18 years of age who have a Junior Operator's or Full License and have~     driven at least once in the month before enrolling in the study may be eligible to~     participate.~      In a university laboratory, participants sit in a 1995 Saturn sedan and operate the controls~     of the car just as they would those of any other car, during simulated drives in urban,~     suburban and rural areas. They are fitted with a head-mounted eye tracker that records their~     point of gaze in real time. On one drive, the subject drives alone; on another, a male~     passenger rides along. After the drives, the subject fills out some questionnaires.~   "
217194|NCT00716365|"~     USF Hemostasis - USage of HemCon for Femoral Hemostasis after Percutaneous Procedures. A~     Comparative Open Label Study The purpose of this trial is to test HemCon pad after diagnostic~     percutaneous coronary angiography as an adjunct to manual compression to better control~     vascular access site bleeding and reduce time-to-hemostasis.~      We hypothesize that the use of HemCon bandage (containing a carbohydrate called chitosan,~     found in the shells of shrimp, lobster and beetles) will shorten the time needed to achieve~     hemostasis, time to patient's ambulation, and patient's satisfaction without increasing~     vascular complications.~      278 patients undergoing diagnostic coronary angiography receiving 2500 u intravenous Heparin~     will be studied and randomized for manual homeostasis with either a HemCon or a regular pad.~     Primary efficacy endpoint will be time to hemostasis. Secondary endpoints will be safety~     (complication rate) and satisfaction of patients regarding time to sitting incline and time~     to ambulation. 25% of patients from each arm will be randomized for Duplex examination of the~     femoral artery at the access site.~   "
217195|NCT00716352|"~     This is a multi-centre UK study designed to evaluate if an educational intervention programme~     delivered to health care professionals can improve the use of evidence based treatments in~     the management of patients admitted to hospital with non-ST elevation Acute Coronary~     Syndrome. A total of 38 centres participated, half received the educational intervention.~     Patients were followed to hospital discharge. Patients were followed up at 6 months. Longer~     term follow up through the Office Of National Statistics will be performed.~   "
217196|NCT00716339|"~     Purpose:~      The aim of this study was to compare the effect of ciliary body training as proposed by~     manufacturers of accommodating IOLs and patient motivation on the pseudoaccommodative ability~     with a standard intraocular lens (SA60AT).~      Setting:~      Department of Ophthalmology, Medical University of Vienna.~      Methods:~      This randomized, controlled, examiner-masked study comprised 80 eyes of 40 patients that~     underwent standard cataract surgery. Patients were randomly assigned to a motivated or~     non-motivated (control) group. In the motivated group, subjects were told to take part in a~     special protocol to improve their near-reading ability after cataract surgery and were~     instructed not to use near adds for at least 3 months. Follow-up examinations included~     best-corrected distance visual acuity (VA), distance-corrected near VA, best-corrected near~     VA, defocus curve and reading speed, as well as pilocarpine-, cyclopentolate- and~     nearpoint-induced IOL shift assessed with partial coherence interferometry.~   "
217197|NCT00716326|"~     The aim of this study is to investigate the effectiveness of TENS in addition to routine care~     in patients with chronic pain of predominantly neuropathic origin, compared to treatment with~     routine care alone.~      Hypothesis:~      An eventually neuropathic pain component is needed to be identified and alleviated in chronic~     pain patients to improve the quality of rehabilitation.~      0-hypothesis:~        -  TENS is not better than than placebo, medication or standard rehabilitation program.~        -  A neuropathic pain component does not demand special considerations in rehabilitation of~          chronic pain patients.~   "
217198|NCT00716300|"~     The aim of the study is to examine the kinetic, anti-oxidant, anti-inflammatory and cellular~     cholesterol efflux properties of high-density lipoprotein (HDL) in subjects with the~     metabolic syndrome (MetS) and lean individuals.~   "
217199|NCT00716287|"~     Anti-angiogenic targeted therapies are used in a wide range of solid tumors including NSCLC,~     breast cancer, GISTs, CRC, renal cell carcinoma and hepatocellular carcinoma. Somatic~     mutations in genes related to tumorigenesis have been associated with treatment response~     whereas germline gene variants have been associated with tumor risk, prognosis and treatment~     related toxicity.Study objectives are:~        1. To characterise the prevalence and clinicopathological associations of germline and~          somatic variation in genes involved in the angiogenic pathway in healthy donors and~          unselected cancer patients~        2. To examine the association between angiogenic gene variants and outcome in patients~          receiving anti-angiogenic therapy~   "
217200|NCT00716274|"~     This study will evaluate the effects of atomoxetine on brain activation during attention and~     reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16~     years old with ADHD and comorbid dyslexia~   "
217201|NCT00716261|"~     Our hypothesis is that intensive training with positive biofeedback may enhance postural~     control and stability in Parkinson's disease patients and in elderly fallers.~   "
217202|NCT00716248|"~     Patients with rheumatoid arthritis who have been well controlled with methotrexate plus~     infliximab may remain in remission or low disease activity without infliximab. And the chance~     of sustained remission increase by the addition of another DMARD, bucillamine, at the time of~     discontinuing infliximab. The BuSHIDO trial is the prospective, randomized, controlled study~     comparing MTX monotherapy and MTX plus bucillamine combination therapy as to the rate of~     disease flare after discontinuing infliximab.~   "
217203|NCT00716235|"~     The purpose of this study is to characterize the profile of executive functions and eye~     movements in several populations of children with developmental disabilities.~   "
217204|NCT00716222|"~     There is a well-documented relationship between short sleep duration and high body mass index~     (BMI). The mechanism linking short sleep duration and weight gain is unknown. Current studies~     in healthy young volunteers have shown that experimental sleep restriction is associated with~     dysregulation of the neuroendocrine control of appetite and with alterations in glucose~     metabolism. The goal of our study is to determine the metabolic and hormonal modifications~     induced by chronic sleep curtailment in obese adolescents and young adults and to observe if~     short sleep is a negative prognostic factor in their weight evolution.~   "
217205|NCT00716209|"~     The proposal seeks to establish:~        -  A comprehensive compilation (database) of clinical information comprising clinical,~          histopathological, treatment and follow-up characteristics of past and future~          gastrointestinal cancer (GIC) cases in Singapore that can be shared by investigators.~          The characteristics will include clinical (eg age, sex, stage), histopathological (eg.~          grade, type), treatment (eg. treatment status, regimens) and outcome data (eg. survival,~          toxicity) from medical records.~        -  A collection (bank) of corresponding frozen and fixed tissue, blood and processed~          samples (enriched blood mononuclear cells, protein, RNA, DNA, tissue arrays) in~          Singapore that can be shared by the investigators.~        -  A gastrointestinal cancer co-operative group (GCCG) of clinicians and scientists~          researching prognostic and predictive markers in GIC, which will benefit from the~          multi-disciplinary knowledge, information and samples of its members.~        -  To characterise genetic polymorphisms related to Gastrointestinal cancer chemotherapy~          treatment in controls (healthy volunteers)~   "
217206|NCT00716196|"~     Objective: The purpose of this study was to compare the performance of the monolayer~     preparation (Cyto Lyt or Thin prep) to the routine use of Papanicolau methods on the analysis~     of specimens obtained using EUS-FNA.~   "
217207|NCT00716183|"~     A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of~     Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for~     4 weeks. The three lactobacilli strains were originally isolated from milk of healthy women.~     On days 0 and 28, milk samples will be collected, and staphylococci/streptococci and~     lactobacilli will be counted and identified. Evolution of clinical signs will be recorded by~     midwifes on days 0, 7, 14 and 28.~   "
217279|NCT00715247|"~     The purpose of this project is to find genes whose mutations cause Polycythemia Vera,~     Essential Thrombocythemia and Primary Myelofibrosis.~   "
217208|NCT00716170|"~     In order to investigate the mechanisms underlying the hyperglucagonemia characterizing~     patients with type 2 diabetes mellitus (T2DM) we wish to test the following hypothesis: Do~     pancreatic alpha-cells exhibit inappropriate glucagon responses to substances released from~     the small intestine (GIP, GLP-2 and GLP-2) in patients with T2DM?~   "
217209|NCT00716157|"~     Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients~     receiving combined chemotherapy and radiation. 83% of patients experience radiation~     therapy-induced vomiting; significant nausea and vomiting could develop with concurrent~     chemotherapy despite standard anti-nauseous medication prophylaxis.~   "
217210|NCT00716144|"~     Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or~     placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and~     efficacy of R115866 will be evaluated during the treatment period and the 8-week post~     treatment follow-up period.~   "
217211|NCT00716131|"~     Despite significant progress in the identification of mechanisms involved in motor neuron~     degeneration in Amyotrophic Lateral Sclerosis (ALS) and other motor system diseases, the~     actual pathogenesis and cause of these diseases remains unknown. Effective treatment of these~     diseases are dependent on the elucidation of their causes. The availability of diseased and~     control human tissues will be a critical resource for this research progress. . Samples of~     serum, spinal fluid, and urine from patients with motor system diseases can be used to study~     biochemical and genetic differences compared to tissues of neurologic disease controls and~     normal controls. Furthermore, the availability of autopsied CNS, PNS, as well as other~     tissues from patients with ALS or suspected ALS are useful for current and future research~     studies into the disease. Therefore, we propose to institute a Tissue Bank containing blood,~     urine, and cerebrospinal fluid donated from not only ALS and other motor neuron disease~     patients, but also those with other neurologic diseases and normals whose tissue can be used~     as controls. In addition there will be an autopsy band for post-mortem specimens of ALS and~     other motor neuron disease patients. Each specimen, whether from a living patient or autopsy~     will be de-identified and accompanied by a standard set of clinical information collected~     from the medical records in order that each specimen is characterized with the relevant~     clinical information to maximize the usefulness of the specimens.~      Once established, this tissue bank will provide a resource in which a large number of samples~     will be readily available and expedite research by circumventing the delays in collecting~     specimens prospectively. These specimens will be used for research in the ALS Center of Hope~     at Drexel University College of Medicine and shared with any outside investigator with a~     valid IRB approved protocol.~   "
217212|NCT00716118|"~     Our aims is to document the possible effect of cryo- preservation at the meiotic spindle and~     mitochondrial levels.~   "
217213|NCT00716105|"~     The purpose of this study is to determine whether infants fed a formula with protein levels~     different than a standard infant formula have similar growth and development.~   "
217214|NCT00716092|"~     The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control~     and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic~     control.~   "
217215|NCT00716079|"~     The purpose of this academic lead study is to determine if a treatment strategy of early~     intensive blood pressure (BP) lowering compared to conservative BP lowering policy in~     patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH)~     improves the outcome of death and disability at 3 months after onset.~   "
217216|NCT00716066|"~     This phase II trial studies the side effects and how well carmustine, etoposide, cytarabine~     and melphalan together with antithymocyte globulin before a peripheral blood stem cell~     transplant works in treating patients with autoimmune neurologic disease that did not respond~     to previous therapy. In autoimmune neurological diseases, the patient's own immune system~     'attacks' the nervous system which might include the brain/spinal cord and/or the peripheral~     nerves. Giving high-dose chemotherapy, including carmustine, etoposide, cytarabine,~     melphalan, and antithymocyte globulin, before a peripheral blood stem cell transplant weakens~     the immune system and may help stop the immune system from 'attacking' a patient's nervous~     system. When the patient's own (autologous) stem cells are infused into the patient they help~     the bone marrow make red blood cells, white blood cells, and platelets so the blood counts~     can improve.~   "
217217|NCT00716053|"~     The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in~     treating patients with advanced upper lobe predominant emphysema.~   "
217218|NCT00716040|"~     All eligible patients will be invited to use electronic monitoring of medication (MEMS)~     during the next six months. After two months with MEMS the enrolled patients will be~     randomized to intervention group or to control group. The intervention group will be~     submitted to four social-psycho sessions with a pre-trained health professional. The control~     group will receive the usual care of the health service.~      The study will compare the rate of adherence to antiretroviral therapy between the~     intervention group and the control group. The duration of the study will be of six months.~     The analysis will be based on intention-to-treat.~   "
217219|NCT00716027|"~     The purpose of this study is to determine whether a modified behavioral treatment for weight~     loss that includes one-on-one treatment for individuals struggling to lose weight is~     associated with more weight loss than a standard behavioral treatment.~   "
217220|NCT00716014|"~     Pachyonychia congenita (PC) is a rare, autosomal dominant keratin disorder affecting the~     nails, skin, oral mucosae, larynx, hair and teeth. Pathogenic mutations in keratin K6a, K6b,~     K16 or K17 act via a dominant negative mechanism, leading to manifestations of the disease.~     The most disabling PC symptom is a painful plantar blistering and keratoderma that requires~     use of ambulation devices in more than 50 percent of patients. Despite our understanding of~     the molecular basis of PC, current treatment is limited to mechanical removal of the thick~     calluses, non-specific topical keratolytics, and oral retinoids, none of which alleviates~     blistering or plantar pain satisfactorily. A public charity, PC Project, has been founded to~     support the development of treatments for PC (www.pachyonychia.org). In collaboration with~     this charity, a small company, TransDerm, Inc., has developed a small interfering RNA (siRNA)~     that specifically targets a mutation in one of the PC keratins, K6a. As this siRNA targets a~     single nucleotide mutation, it will only be effective against PC subjects harboring this~     specific mutation. There are currently only six known patients who carry this mutation in the~     International Pachyonychia Congenita Research Registry, but three of these patients live in~     Salt Lake City (a mother and two of her children). We propose to perform a Phase Ib clinical~     trial to test the safety and tolerability of TD101 in PC patients carrying an N171K mutation.~     We will complete treatment of the adult patient prior to recruitment of the minors.~   "
217221|NCT00716001|"~     This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the~     prevention of contrast-induced nephropathy.~   "
217222|NCT00715988|"~     The Primary objectives of this proposal are to determine the population kinetics for~     methadone and its enantiomers in preterm newborns and infants at 29 weeks to 48 weeks post~     menstrual age (PMA) who are 1 week old and older and establish any correlations of the~     kinetics with PMA to determine the bioavailability for enterally administered methadone in~     these newborns and young infants.~      The secondary objectives of this proposal are to explore possible genotypic changes in~     CYP3A4-3A7-3A5, CYP2B6, CYP2C8, CYP2C19, and CYP2D6 and PGO on the kinetics of methadone in~     neonates and young infants and to test the safety of methadone in this population by~     correlating the plasma concentrations of the methadone enantiomers, S-methadone and~     R-methadone, with changes in cardiac repolarization by measurement of corrected QT, heart~     rate, and blood pressure.~   "
217223|NCT00715975|"~     The Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells~     epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly~     lesions in various areas of the body, preferably in the scalp, region and religious joints as~     elbows and knees. It occurs equally in both sexes and can appear at any age, and the mean age~     for the onset of the disease and around 27.3 years.~      The halobetasol propionate and an ultra-potent corticoid. Its chemical structure and similar~     to the Clobetasol corticoid this, until then classified as the most potent corticoid used~     worldwide in clinical practice. However, the molecular structure of Halobetasol gives it~     increased its activity antiinflammatory and anti-proliferative.~      The objective of this study is evaluating the efficacy and tolerability of the drug~     Halobetasol propionate cream formulation as a treatment in patients with plaque psoriasis~     mild to moderate, compared to the substance of similar power, Clobetasol propionate - Psorex~     - Cream.~   "
217224|NCT00715962|"~     Low mobility, defined as being limited to bed or chair, is common during acute~     hospitalization. This study will evaluate the impact and safety of a hospital walking program~     for older patients during acute general medical hospitalization. Participants who are 65~     years of age or older, will be randomized to usual care (UC) or to a hospital walking program~     (WP), which includes twice daily walks with assistance, provision of necessary ambulatory~     devices, and a behavioral intervention strategy designed to encourage out of bed activity.~     Throughout hospitalization, the WP and UC veterans will were wireless monitors on the thigh~     and ankle that measure activity. The primary goal will be in increase the length of time~     veterans spend out of bed and to assure this out of bed activity is safe.~   "
217225|NCT00715949|"~     Brain injuries from trauma are common in children, often resulting in death and disability.~     Most brain injuries are minor, yet their treatment can be challenging. Because there are many~     different scales used to characterize the severity of brain injury, there is no consensus~     regarding how to manage patients with minor brain injuries. Specifically, there is no~     agreement on recommendations regarding the safety of return to activities following injury.~     In young athletes with minor brain injuries (i.e. concussions) there is strong data~     suggesting that return to baseline neurologic function is often delayed by days or weeks.~     Children allowed to return to activities too soon may be at a higher risk for a second~     concussion, may delay recovery or, in rare cases, die. Researchers have designed a~     computer-based testing system (ImPACT©) to objectively test for neurologic deficits following~     injury. This test has been used primarily in athletes following a concussion but is also~     applicable to children with brain injuries from non-sports related traumas. We propose to~     utilize this testing in pediatric patients admitted to the hospital with minor brain injury.~     The test would be administered at the time of the hospitalization as well as in the~     outpatient trauma clinic at the time of routine follow up. The test would allow us to~     determine if there are neurologic deficits, potentially subclinical, in these brain injured~     patients and how quickly they recover from their injuries. If successful, the testing will~     likely be useful in other clinical settings such as the primary care office (e.g.~     pediatrician), specialty care office (e.g. sports medicine), or emergency room to determine~     if an injured child requires additional intervention.~   "
217226|NCT00715936|"~     The purpose of this study is to evaluate whether the integration of an early child~     'stimulation and care for development' intervention, either alone or in combination with an~     'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with~     infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial~     outcomes on child development (cognitive, language, motor and social emotional development)~     and child growth.~   "
217227|NCT00715923|"~     Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be~     randomized to receive either a standard informed consent document or a modified document that~     is shorter and more easily understood than the standard document. The hypothesis is that~     using a shorter form that is more easily understood and more visually simple will lead to~     greater subject satisfaction in the consent process and will not compromise subject~     comprehension of key study aspects. Consent for study inclusion has been waived by the IRB~     because informing subjects of the nature and process of the study would likely affect the~     findings, and both the standard and modified consent forms were approved for use in the~     nutrition study.~   "
217228|NCT00715910|"~     In this study, the concentration of antibody to the vaccine one year, three and five years~     after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine~     GSK134612 and Menactra® in a previous study (whose objectives & outcome measures are~     presented in a separate protocol posting with NCT number =00454909) will be evaluated. The~     safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years~     post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612~     vaccine will also be evaluated.~   "
217229|NCT00715897|"~     The aim of the current work was to evaluate, for the first time in a prospective randomized~     study, the effect of HBOT on patients with chronic neurological deficiency due to stroke.~   "
217230|NCT00715884|"~     The objective of this study is to show similar (non-inferior) safety and effectiveness~     between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a~     prospective, multi-center, randomized clinical study for the treatment of de novo native~     coronary lesions.~   "
217231|NCT00715871|"~     The purpose of this study is to determine whether the Smoke-Break nicotine delivery device~     can help smokers quit smoking, while avoiding many of the side effects associated with other~     smoking cessation products.~   "
217232|NCT00715858|"~     The purpose of this study is to examine the cerebrospinal fluid (CSF) of patients with~     Alzheimer's disease for biomarkers of inflammation and their response to the antibiotics~     doxycycline and rifampin. The results of this preliminary analysis will be used in defining~     the direction of further research.~   "
217233|NCT00715845|"~     The purpose of this study is to determine if blowing carbon dioxide into the surgical field~     during open-heart surgery to displace retained chest cavity air from the atmosphere will~     decrease the number of microembolic being introduced into the heart chambers and brain.~   "
217234|NCT00715832|"~     The study uses a molecule or particle that is found only on cancer cells and is unique to~     cancer cells, as it is not detected on normal tissue. The molecule is known as oncofetal~     antigen or OFA. Because OFA is unique to cancer, the investigators feel OFA could be used to~     educate the patients' own defenses to more effectively fight the cancer on her own, he or she~     is harboring. Although investigators found OFA to be present in large concentrations on all~     cancers, it was found to be especially abundant in breast cancers. Therefore, the~     investigators feel that this molecule would be a good target for stimulating patient defenses~     especially against breast cancer cells. To accomplish this, certain defense cells (immune~     cells) will be washed out from the patients' blood using a machine to which the patient is~     connected through two small cannulas placed into veins located in the patients' arms. Those~     cells will be manipulated in the laboratory with artificially engineered OFA. These~     reeducated cells will be injected into the skin of patients. There will be a series of~     three skin injections in 4 week intervals. It is hoped that this treatment will convert the~     patients' defenses to a point that effective anti cancer responses will be induced.~     Effectiveness of the treatment will be monitored with blood tests and assessment of the size~     of the cancers.~   "
217235|NCT00715819|"~     Stanford University Dermatology Clinics and Lucile Packard Children's Hospital are evaluating~     the use of the otoscope for the diagnosis of skin lesions. We are particularly looking for~     children and/or adults with nodules, cysts, tumors, or pilomatricomas. The study will take~     15-30 minutes and we will use light to examine and take a picture of your skin lesion. There~     is no monetary compensation for participating in the study.~   "
217236|NCT00715806|"~     The objective of the study is to determine the ability of open magnetic resonance imaging~     (MRI) scanners to reduce claustrophobic reactions, thereby enabling more examinations of~     severely anxious patients. The investigators hypothesize that anxiety-based claustrophobia~     that prevents MR examinations without sedation can be reduced using an open MR scanner design~     thereby improving clinical management of those patients.~   "
217237|NCT00715793|"~     The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in~     improved clinical response.~   "
217238|NCT00715780|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy~     while using insulin under normal clinical practice conditions. The switch from OAD treatment~     to insulin therapy will be determined by physician.~   "
217239|NCT00715767|"~     This is a randomized, multi-center intervention trial comparing two educational programs on~     healthcare provider performance in the Botswana national hospital system. This study~     addresses the critical question of how to effectively and consistently measure and associate~     CPR knowledge and psychomotor skills, enabling the optimization of the learners' environment.~   "
217240|NCT00715754|"~     The purpose of this research is to study whether fetal biometrics obtained by 2-D ultrasound~     can predict infant adiposity by air displacement plethysmography at birth.~   "
217241|NCT00715741|"~     The purpose of this study is to determine whether breathing high levels of oxygen during~     surgery affects oxygen levels after surgery. The second purpose of this study is to determine~     whether giving positive end expiratory pressure PEEP and high oxygen together affects~     patients oxygen levels after surgery.~   "
217242|NCT00715728|"~     This study will test the hypothesis that an electric heating device, the Hot Dog warming~     system is as effective as the Bair Hugger forced air heating system.~   "
217243|NCT00715715|"~     Patients with chronic hepatitis B constantly produce the virus in the body. The disease of~     chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this~     response. After taking steroids, viral production usually increases and liver function tests~     increase. After stopping steroids, viral production usually decreases. Many studies in the~     past have studied taking a low dose steroid before treating hepatitis B. Those studies have~     shown that low dose steroids help your body to clear the virus. The goal of this study is to~     improve the liver function by slowing viral growth.~   "
217244|NCT00715702|"~     The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672~     in patients with renal impairment by comparing with healthy volunteers~   "
217245|NCT00715689|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone~     deficient adults~   "
217246|NCT00715676|"~     This study will evaluate the effect of a 1-year administration of the vitamin D analog~     2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density~     (BMD), safety, and tolerability.~   "
217247|NCT00715663|"~     This study is conducted in Asia. The aim of this observational study is to evaluate safety,~     efficacy and convenience in using NovoMix® 30 FlexPen® in type 2 diabetes under normal~     clinical practice conditions.~   "
217248|NCT00715650|"~     This study will address the problem that claimants with psychiatric disabilities who apply~     for and receive disability benefits go on to work less than those whose claims are denied.~   "
217249|NCT00715637|"~     Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been~     extensively studied in patients with malignant solid tumors. Amonafide has also been studied~     in patients with AML.~      The purpose of this study is to assess the relative efficacy and safety of amonafide in~     combination with cytarabine compared to daunorubicin with cytarabine in subjects with~     documented secondary AML.~   "
217306|NCT00714896|"~     Examine the efficacy of a stepped-care smoking cessation intervention for current and former~     smokers in chemical dependency treatment programs. We hypothesize that those who received the~     stepped-care intervention will be more likely to report smoking abstinence and drug or~     alcohol abstinence at 6 months.~   "
217250|NCT00715624|"~     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in~     comparison to placebo, as an add-on treatment to basal insulin with or without metformin over~     a period of 24 weeks of treatment, followed by an extension.~      The primary objective is to assess the effects of lixisenatide when added to basal insulin on~     glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.~      The secondary objectives are to assess the effects of lixisenatide when added to basal~     insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal~     challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of~     patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in~     7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total~     insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide~     antibody development.~   "
217251|NCT00715611|"~     For patients with this type of cancer, the standard of care is treatment with chemotherapy.~     Radiation therapy is typically not used. This is because radiation to the entire lining of~     the lung has many side effects that are often severe including damage to the lung~     (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy~     (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy.~     This type of radiation therapy specifically targets the lining of the lung, where you have~     your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is~     to test the safety and implementation of standard pleurectomy/decortication (removal of the~     surface lining of the lung) performed at other centers. Patients will undergo~     pleurectomy/decortication chemotherapy and hemithoracic pleural IMRT to the pleura in~     patients with malignant pleural mesothelioma.~   "
217252|NCT00715598|"~     The purpose of the study is to improve a questionnaire (the Pain Quality Assessment Scale)~     used for measuring different types of pain people may experience. An improved version of this~     questionnaire will help researchers better understand the impact of pain treatments on~     different types of pain through the use of this questionnaire.~   "
217253|NCT00715585|"~     This study examines the impact of certified diabetes education, and the role of different~     educational approaches to medical nutrition therapy. in addition the role of patient health~     literacy level is assessed~   "
217254|NCT00715572|"~     The objective of this study was to analyze the features of monotherapy with L-T4 in~     comparison with combined therapy with L-T4 and L-T3 in patients with primary hypothyroidism.~   "
217255|NCT00715559|"~     The purpose of this study is to determine whether cysteamine bitartrate, an FDA-approved drug~     for a non-psychiatric condition, is safe and effective for the treatment of major depression.~   "
217256|NCT00715546|"~     The aim of this study is to determine the safety of the autologous transplantation of~     adipose-derived stem cells in the treatment of lipodystrophies.~   "
217257|NCT00715533|"~     The purpose of this study is to compare clinical and economic parameters of stroke patients~     who have received acute MRI imaging (test group) to patients who have received routine CT~     imaging (control group) in the clinical setting of acute stroke.~   "
217258|NCT00715520|"~     The purpose of this study is to use (Transcranial Magnetic Stimulation) TMS or drugs to~     improve learning of movement skills and the adaptation processes in patients after stroke.~     Once investigators have determined the improving effect of TMS and the drugs on learning of~     movement skills, the study team may be able to provide information that improves~     rehabilitative treatment and helps to improve recovery after stroke.~   "
217259|NCT00715507|"~     To assess the clinical utility of the graphical medication monitor, results of the~     anesthetics for which the display was present will be compared to the results of the~     anesthetics in which there was no display.~   "
217260|NCT00715494|"~     Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal~     cost to ICU survivors who frequently experience significant cognitive impairment and an array~     of physical and functional disabilities that limit their recovery and quality of life. While~     the problems experienced by these patients are likely amenable to rehabilitation, few ICU~     survivors receive focused rehabilitation following hospital discharge. The purpose of this~     study is to initiate and test the feasibility of a complex intervention incorporating a~     cognitive, physical, and functional rehabilitation program at the time of hospital discharge~     and implement this 12 week program using in-home visits and tele-technology. We hypothesize~     that this interdisciplinary rehabilitation program, initiated at hospital discharge and~     implemented using in-home visits and tele-technology, will result in improved recovery of~     neuropsychological and physical performance and overall functional status.~   "
217261|NCT00715481|"~     Reduced glomerular filtration rate (GFR) has been recently shown to be a powerful predictor~     of cardiovascular morbidity and mortality in the general population, independent of~     traditional cardiovascular risk factors.~      This observational study is aimed at assessing the association of reduced estimated GFR with~     cardiovascular morbidity and mortality in a large italian population (at least 15,000~     subjects) of type 2 diabetic outpatients over a 4-year follow-up.~   "
217262|NCT00715468|"~     Treatment with MMF often results in adverse GI events, which can lead to dose reductions of~     MMF and decreased graft function. Enteric-coated mycophenolate sodium (MYFORTIC*) was~     developed as an alternative formulation of MPA to improve upper GI tract side effects. An~     improvement in the severity of GI side effects could result in an increased tolerance to MPA~     and an improvement in patient quality of life. This study will use the GSRS to evaluate~     improvement in gastrointestinal symptoms.~   "
217263|NCT00715455|"~     The purpose of this study is to determine if it is feasible and safe to use the REG1~     Anticoagulation System instead of unfractionated heparin during percutaneous coronary~     intervention (PCI) in subjects with coronary artery disease (CAD).~   "
217264|NCT00715442|"~     The goal of this clinical research study is to learn if Sutent® (sunitinib malate), given~     before surgery, can help control renal cell carcinoma. The safety of sunitinib malate will~     also be studied.~   "
217280|NCT00715234|"~     A study team with extensive experience in immunization delivery research will evaluate the~     effectiveness of vaccination reminder/recall systems for adolescent patients in five types of~     clinical settings including: urban pediatric, urban family medicine and rural family medicine~     practices, public pediatric clinics, and school-based health centers. Randomized controlled~     trials of reminder/recall for adolescents will be conducted at each type of site, with~     randomization at the level of the patient.~   "
217265|NCT00715429|"~     1. Research question: Does vitamin D reduce the frequency and severity of nocturnal leg~          cramps in older persons who previously took quinine for leg cramps?~        2. Experimental Design: This is a randomized, double blind, placebo controlled study of 70~          men and women veterans receiving care at the Madison VA Medical Center or at the~          University of Wisconsin Hospitals and Clinics. Individuals age 50 or more who have~          previously taken quinine for nocturnal leg cramps and meeting baseline criteria are~          eligible to enroll. Enrollees meeting laboratory criteria, including low-normal vitamin~          D levels, will undergo a 2-week diary run-in period to confirm cramp frequency. Those~          who report two or more leg cramps in each week will continue in the study and will be~          randomized to vitamin D or placebo. After a two-week wash-in, subjects will take a~          vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly~          vitamin D (50,000 units) maintenance dose for 7 weeks. Subjects will record by diary the~          number and severity of leg cramps from the start of the diary run-in until a week~          after the last dose of study drug. Study investigators will call subjects at scheduled~          intervals to assess compliance, tolerability, and diary use.~        3. Major risks to subjects: No major risks are anticipated. Excessive vitamin D can~          increase blood calcium levels (hypercalcemia), with symptoms such as thirst, nausea, and~          weakness. However, symptomatic hypercalcemia has not been reported except for those~          taking more than 40,000 units daily for several months. This is far above the cumulative~          dose in our study.~        4. Potential benefits: Subjects may not receive any benefit. Vitamin D may alleviate leg~          cramps for subjects who receive it.~        5. Consent Procedure: Flyers describing the study and telephone contact information will be~          mailed to patients who have received quinine during the period 2002-2007. The PI or~          Co-PI will return calls to describe the study and answer any questions. For persons~          meeting preliminary (pre-lab) study criteria, two copies of the consent form will be~          mailed, with the patient mailing back one signed consent to the PI.~   "
217266|NCT00715416|"~     The investigators evaluated whether primary implantation of a self-expanding nitinol stent~     yielded anatomical and clinical benefits superior to those afforded by percutaneous~     transluminal angioplasty with optional secondary stenting.~   "
217267|NCT00715403|"~     The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms~     of incidence and intensity of Adverse Events and changes in safety laboratory parameters.~      Secondary objectives are the collection of further safety data (vital signs), efficacy data~     and the determination of pharmacokinetic characteristics during long-term therapy with BIBF~     1120.~   "
217268|NCT00715390|"~     To describe the types and incidence of cardiac dysrhythmias that occur under anesthesia in~     the present anesthesia environment.~   "
217269|NCT00715377|"~     Anticholinergic antiparkinsonian agents often cause side-effects including cognitive~     impairment, dry mouth, and constipation while they diminish antipsychotic-induced~     parkinsonian symptoms. The introduction of second generation antipsychotics (SGA) brought~     fewer neurological side effects. However, anticholinergic coprescription rates are still as~     high as 12-65% in patients on SGA that are much higher than the incidence of EPS reported in~     clinical trials (3-20%). This apparently discrepancy is likely explained, in part, by the~     established tradition of routine use of this medications. Older patients are particularly~     sensitive to anticholinergic side-effects due to age-related changes in pharmacokinetics and~     pharmacodynamics. In this study, we will examine the safety and benefits of reducing the dose~     of a frequently prescribed anticholinergics, benztropine, on cognitive function,~     extrapyramidal symptoms, and psychotic symptoms in older subjects with a primary psychotic~     disorder.~   "
217270|NCT00715364|"~     To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke~     patients.~      To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265,~     when compared with patients given a placebo control.~   "
217271|NCT00715351|"~     This trial is conducted in Europe. The aim of this observational study is to evaluate the~     glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes~     with Levemir® compared to Insulatard® under normal clinical practice conditions.~   "
217272|NCT00715338|"~     Collect exhaled breath condensates from patients scheduled for a routine surgical procedure~     before, during, and after surgery for measurements of IsoFs~      Draw blood from patients scheduled for a routine surgical procedure before, during, and after~     surgery for measurements of serum thrombomodulin.~   "
217273|NCT00715325|"~     The purpose of this study is to determine whether the ProtectiScope CS is capable to perform~     diagnostic and therapeutic colonoscopy.~   "
217274|NCT00715312|"~     Rationale: The effect of positional distribution of dietary fatty acids on markers of~     inflammation and blood lipids metabolites on diets containing fatty acids such as oleic acid~     that are associated with reduced risk of cardiovascular disease is not widely studied.~      Hypothesis: There would be difference detected in the concentrations of markers of~     inflammation and blood lipid metabolites in human volunteers fed controlled diets.~      Study design: A randomized, double-blind, crossover clinical trial that involves 41 healthy~     volunteers. The volunteers will be selected based on inclusion and exclusion criteria. They~     will consume controlled diets for 5 weeks that provides 15% of energy from protein, 30% of~     energy from fat, and 55% of energy from carbohydrates. Volunteers will be assigned to each~     test diets which is cooked with novel olein, palm stearin or partially hydrogenated soybean~     oil in random order until all three diets has consumed by each person.~      Main study parameters: LDL-cholesterol~   "
217275|NCT00715299|"~     This is a research study to examine a new type of walking therapy for people after they have~     had a stroke. We will study how people move and how their muscles work to see how the therapy~     helps people to walk better and to see how the therapy can be improved.~   "
217276|NCT00715286|"~     To determine the impact of Neoadjuvant chemotherapy on surgical debulking rate, overall and~     disease-free survival and quality of life (QOL) in patients with advanced EOC.~   "
217277|NCT00715273|"~     Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls~     of arteries. This study will examine the effectiveness of a combination of~     cholesterol-lowering medications at decreasing the fat content of atherosclerotic deposits in~     people who have coronary artery disease or carotid artery disease.~   "
217278|NCT00715260|"~     The purpose of this observational study is to better understand the natural history/natural~     course of uremic pruritus (UP) - itching associated with chronic kidney disease(CKD). During~     the lifetime of a CKD dialysis patient, UP tends to be a prolonged, frequent, and an intense~     itch that is known to impair the patient's quality of life (QoL), including sleep and mood.~      The study will follow hemodialysis (HD) patients longitudinally to characterize their~     pruritus over time. The study will quantify and characterize UP and assess change over time;~     collect data on conditions that may be affected by UP such as sleep, mood, socialization and~     overall quality of life; collect data on use of medications, particularly anti-pruritic~     treatments, sleep aids, and medications for depression and anxiety; and collect data on~     medical resource use, particularly hospitalizations for treatment of skin and other~     infections over the duration of the study.~   "
217281|NCT00715221|"~     We are proposing a clinical investigation of the pathogenesis of insulin resistance (IR) in~     skeletal muscle and adipose tissue (AT), focusing specifically on the contributions of~     glucose delivery, transport and phosphorylation. The primary methodology will be dynamic PET~     imaging, using three tracers that respectively portray the kinetics of glucose delivery,~     bi-directional trans-membrane glucose transport and glucose phosphorylation. The three~     tracers are: 1) [15O]-H2O for quantifying tissue perfusion, this portrays the kinetics of~     glucose delivery from plasma to tissue; 2) [11C]-3-O-methyl glucose, a tracer constrained to~     bi-directional trans-membrane glucose transport; and 3) [18F]-fluoro-deoxy glucose, which~     like [11C]-3-OMG is transported, but adds the subsequent metabolic step, that of glucose~     phosphorylation.~      We propose 2 specific aims to apply this methodology to investigate the pathogenesis of IR.~     The 1st aim is to quantitatively assess the kinetics of glucose delivery, transport and~     phosphorylation in skeletal muscle in type 2 DM and as compared to obese and lean~     non-diabetic men and women. We will appraise the contribution of each step to the to the~     pathogenesis of IR. We postulate more severe IR in oxidative muscle, with a dual impairment~     of glucose transport and phosphorylation. The 2nd aim is to implement the triple-tracer~     dynamic PET imaging protocol in adipose tissue (AT), examining normal insulin action in~     non-obese volunteers and testing whether differences in AT insulin action are present in~     obese insulin sensitive volunteers compared to obese IR participants and the relation of AT~     IR to that of muscle and liver.~   "
217282|NCT00715208|"~     This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the~     safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a~     combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone~     (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone~     (VELCADE-R-CP) based on investigator preference. Following completion of the treatment~     period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.~   "
217283|NCT00715195|"~     Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve~     months after the end of the program, remain higher in Plurifocal educational group than in~     control group~   "
217284|NCT00715182|"~     This is a phase I/II open-label study to delineate the safety, efficacy, pharmacokinetics~     (PK) and pharmacodynamics (PD) of TKI258. The eligible subject population consists of~     subjects who have been diagnosed with advanced or metastatic renal cell cancer that is~     refractory to standard therapy or for which no curative standard therapy exists.~   "
217285|NCT00715169|"~     This study is a, randomized, double-blind, placebo-controlled phase 2a trial evaluating the~     potential of MLN1202 to reduce circulating levels of C-reactive protein (CRP)in patients with~     risk factors for Atherosclerotic cardiovascular disease (ASCVD). Patients with risk factors~     for ASCVD will be screened for inclusion and exclusion criteria including assessment of~     C-reactive protein. If the patient's CRP is greater than 3.0 mg/L on repeated measurements at~     least 2 weeks apart, the patient will be enrolled, stratified by screening CRP levels (≤5.0~     mg/L and >5.0 mg/L), and randomized to receive 1 dose of either placebo or MLN1202. Safety~     will be assessed by vital signs, physical examination, clinical laboratories at baseline, and~     adverse event (AE) reporting from Day 1 to Day 113 of the trial.~   "
217286|NCT00715156|"~     This study is aimed at verifying the role and the efficacy of the recombinants allergens Pru~     p 1, Pru p 3 and Pru p 4, Bet v 1, Bet v 2 and Bet v 4 in the diagnosis of peach allergy~   "
217287|NCT00715143|"~     The purpose of this study is to collect and evaluate long-term safety and effectiveness data~     on the Exactech® NOVATION ™ Ceramic Articulation Hip System (NOVATION ™ Ceramic AHS). Ten~     (10) years of follow-up data will be collected in this study. The first five (5) years of~     subject follow-up will involve clinical (Harris Hip Score, adverse events), radiographic, and~     self-assessment evaluation. The remaining five (5) years of subject follow-up will be~     accomplished with an outcomes questionnaire that will be completed by the subjects to~     evaluate the survivorship status of their hip replacement.~   "
217288|NCT00715130|"~     H1: The increase in body mass index between baseline and two year follow-up among~     intervention worksites will be lower than that among control worksites, such that the~     differential change will be negative on average.~   "
217289|NCT00715117|"~     It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing~     endogenous enkephalin levels in subjects with active Crohn's disease. This is especially~     important in children who often are suffering from nutritional deprivation which retards~     their growth.~      The key objectives are to:~        1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using~          the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers,~          weight, and pediatric quality of life survey.~        2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with~          active Crohn's Disease.~        3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma~          opioid (enkephalin and endorphin levels) and proinflammatory cytokines.~   "
217290|NCT00715104|"~     This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant~     treatment in men with localized prostate cancer.~   "
217291|NCT00715091|"~     This is a randomised, controlled, multi-centre clinical trial on AS patients. Experimental~     intervention: continuous (daily) treatment with diclofenac cholestyramine 150 mg (Voltaren~     Resinate), divided into 75mg Voltaren twice dailyControl intervention: treatment on-demand~     (as needed) with diclofenac-cholestyramine 75 to 150 mg (Voltaren Resinate). The treatment~     strategy of the control intervention (on-demand) reflects current clinical practice in AS.~     Duration of intervention per patient: 2 years Follow-up per patient: safety assessment 3~     months after termination of the trial.~   "
217292|NCT00715078|"~     This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with~     metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with~     different concentrations of PA2024 antigen~   "
217293|NCT00715065|"~     We plan to study patient who faint in response to the sight of blood and compare them to~     healthy subjects who do not. We are going to use a special type of MRI scan (functional MRI)~     to determine if there are differences in brain activation in response to seeing bloody or~     gory pictures that occur before the fainting occurs.~   "
217307|NCT00714883|"~     The primary objective of this study is to evaluate the target lesion failure rate of the NEVO~     Sirolimus-eluting Coronary Stent System.~   "
217294|NCT00715052|"~     Traumatic brain injuries (TBI) are a major cause of morbidity and mortality worldwide. Due to~     improvements in emergency medical care, transportation and specialized trauma facilities, the~     number of people surviving TBI with impairment has significantly increased in recent years.~     The long term cognitive sequelae, which are often not visible persist far beyond the~     resolution of the obvious physical disabilities. This combined with the relatively low~     awareness of the general public has designated TBI as the silent epidemic (TBI CDC 2006).~     Hyperbaric oxygen therapy (HBOT) has been suggested as a possible treatment modality for~     these cases and preliminary studies are promising.~      The purpose of this study is to evaluate the effectiveness of HBOT in the treatment of~     chronic mild traumatic brain injuries (mTBI). Sequential SPECT scans of the brain and~     neurocognitive testing will be used to evaluate cerebral blood flow (CBF) response, cognitive~     and functional improvement following treatment.~   "
217295|NCT00715039|"~     The study is to assess the performance characteristics of a new measure to assess onset of~     efficacy in a GAD patient population.~   "
217296|NCT00715026|"~     This is a post-approval study with prospective enrollment in the United States and a~     retrospective enrollment outside the United States to obtain functional, quality of life and~     radiographic data, which will facilitate assessment of the clinical performance of the Zimmer~     Trilogy AB Acetabular Hip System.~   "
217297|NCT00715013|"~     Patupilone trial for patients with recurrent glioblastoma, which are planned for~     re-operation. Objectives: prolongation of PFS compared to patients with re-operation only,~     Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone.~     Translational research of tumor tissue exposed to patupilone.~        -  Trial with medicinal product~   "
217298|NCT00715000|"~     This prospective randomised study comparing administration of a hypo-osmolar oral hydration~     solution with the classical hydration via IV (intravenous) infusion in premature infants of~     more than 32 weeks GA (gestational age) aims to determine whether administration of a~     hypo-osmolar oral hydration solution is as efficient as intravenous infusion.~   "
217299|NCT00714987|"~     -  ARDS is a severe pathology with high mortality and morbidity.Actual ventilatory~          management is clear for the set of the tidal volume and for the survey of the plateau~          pressure for the patients who require mechanical ventilation.~        -  The set of the PEEP (low or high levels) remains unclear : it seems that some patients~          need low levels of PEEP whereas anther need high levels; but there is no validated data~          that can discriminate them.~        -  We hypothesized that patients with low levels of EVLW ( measured with the Picco® system~          ) need low level of PEEP to ameliorate their oxygenation ( measured with the PaO2/FiO2~          ratio ) whereas patients with high levels of EVLW) need high levels of PEEP.~   "
217300|NCT00714974|"~     This is a prospective, randomized, blinded study in which patients will be enrolled into~     either treated(BIS group) or untreated (non-BIS) group employing bispectral analysis to~     measure the level of sedation/analgesia in patients receiving neuromuscular blocking agents.~      To collect pertinent data on critically ill patients while they are receiving NMBA's. In~     particular to correlate sedation/analgesic medication needs between a group whose medication~     use is determined by the values obtained by bispectral analysis to a group who will have~     medications delivered by the standard of care presently used in the intensive care unit in~     which they are being treated.~      To document that patients who are monitored with bispectral analysis are able to achieve an~     appropriate level of consciousness in a shorter time and require less manipulation and~     amounts of sedative or analgesic medications than those who are not monitored.~   "
217301|NCT00714961|"~     The purpose of this study is to determine if the combination of aspirin plus clopidogrel is~     more effective than aspirin alone in preventing another heart attack, chest pain, stroke or~     death in people who have already had a heart attack that was treated with fibrinolytic~     therapy.~   "
217302|NCT00714948|"~     Standard chemotherapy drugs generally work by killing rapidly dividing cells in your body.~     Cancers cells are some of the most rapidly dividing cells and that is why chemotherapy can be~     effective in some patients. Gemcitabine and Cisplatin are an effective and standard drug~     combination used to treat locally advanced and metastatic urothelial cancer. However, these~     drugs do not shrink tumors in all patients and when they do, it is generally for a limited~     amount of time. This has led scientists to look for different ways to treat cancer.~      New drugs have been developed to treat cancer that work differently than standard~     chemotherapy drugs. These drugs attempt to decrease the blood supply to tumors. By doing so,~     this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing.~     Sorafenib is an example of a drug that works in this way.~      In some patients with advanced kidney cancer, sorafenib alone has been shown to slow the~     progression of their disease. The purpose of this study is to find out what effects, good~     and/or bad, the combination of gemcitabine, cisplatin, and sorafenib has on you and your~     cancer.~   "
217303|NCT00714935|"~     Decision Aids (DA) to inform patients about health care options and help them to participate~     in their care choices are widely advocated. The main argument for offering patients a choice~     is that patients' preferences vary, and health professionals cannot always know what is~     best for an individual, specially when different outcomes have different benefits and risk~     profiles. The standard modes of treatment for patients with coronary artery disease (CAD) are~     coronary artery bypass graft (CABG) surgery, medication, and angioplasty. All three~     treatments for CAD work better when combined with cardiac risk factor modification behavior~     (CRFMB). CRFMB is important for the general public, but it is even more important for people~     with CAD because people with CAD have more at stake. In this RCT study we will evaluate the~     effectiveness of a CAD-DA with and witout an additional decision counseling program (DCP) on~     health outcomes and quality of life to improve enhancement of adherence to cardiac risk~     modification behavior. The CAD-DA is developed by the Ottawa Health Research Institute and~     Division of Clinical Epidemiology at Montreal General Hospital, for CAD patients facing the~     decision of making lifestyle changes to lower their cardiac risk factors. It provides~     patients with information about what they can you do to prevent the disease from progressing.~     The DCP is designed to systematically guide patients through the process of deciding what~     cardiac risk modification behaviors are important for them to carry out. A RCT where 360 CAD~     patients > 18 of age scheduled for an angiogram at Rikshospitalet University Hospital in~     Norway (RH) will be randomly assigned to: (1) CAD-DA group where subjects will receive, for~     take home, the CAD-DA prior to their scheduled angiogram; (2) DCP group where subjects in~     addition to the CAD-DA will receive an individual decisional counseling program (DCP) from a~     trained nurse counselor in their homes prior to their angiogram; and (3) the control group~     who will receive usual care. Data will be collected at four points: at the initial visit~     (T1), 2 months (T2), 4 months (T3) and 6 (T4) months after angiogram~   "
217304|NCT00714922|"~     The objective of the study is to compare clinical outcomes from PRK and SBK using~     FDA-approved laser technology in the same patient~   "
217305|NCT00714909|"~     In order to avoid to use a traumatic and iatrogenic examen (phlebography), the purpose of the~     study is to validate echography doppler in the diagnosis of asymptomatic related catheter~     related thrombosis.~   "
217308|NCT00714870|"~     We are currently experiencing an epidemic of obesity in the Pediatric Population. This~     epidemic affects many areas including quality of life.~      We have been conducting a nutrition and exercise program since 2003. We have noticed that~     many of the participants seem to have a better quality of life after finishing the one year~     program compared to when they started. We would like to objectively quantify this improvement~     using a validated questionnaire at the beginning and at the end of the study. Questionnaires~     will be given to participants and to their caretakers at the same time. There will be two~     groups in the study: one intervention (minimum attendance of 4 sessions) and one control~     group.~   "
217309|NCT00714857|"~     Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist~     registered for sedation of patients in intensive care units. Although the pharmacokinetics of~     dexmedetomidine have been studied previously also in an ICU setting, there is no information~     on the pharmacokinetics of long-lasting (>48 hours) dexmedetomidine infusions in humans.~      The aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine~     infusions in ICU patients using the population pharmacokinetics approach.~   "
217310|NCT00714844|"~     The purpose of the study is to investigate the weight-sparing effect of detemir and assess~     glycemic control and treatment satisfaction when switching from NPH to detemir, to improve~     metabolic control.~   "
217311|NCT00714831|"~     Declining physical activity and the associated rising burden of disease is a major~     public-health problem and it has long been known that being physically active has positive~     health effects. The virtual absence of a public health practice infrastructure for the~     promotion of physical activity at the local level presents a critical challenge to control~     policy for chronic disease. We aimed to assess the efficacy of a 3-months physical activity~     program in primary health care to create adherence to physical activity in sedentary~     individuals.~   "
217312|NCT00714818|"~     Women with a close relative who has experienced mental illnesses like schizophrenia, bipolar~     disorder or schizoaffective disorder often have a poor understanding of the causes of the~     illness, and are often very worried about the chance that any children that they have will~     become affected with the same illness. Often, because of this fear, these healthy women~     choose not to have children.~      Genetic counseling is a process where information about the causes of illnesses, and about~     chances for family members of individuals with these illnesses to become similarly affected~     is provided in a supportive environment by a specially trained healthcare professional. This~     study will investigate whether genetic counseling can reduce perceptions of risk and stigma,~     and increase perceived control and knowledge about the causes of the illness, amongst women~     who have a first degree relative with a major mental illness.~   "
217313|NCT00714805|"~     Recent evidence implicates abnormalities of autonomic function in ALS including problems with~     gastrointestinal (GI) motility. GI complaints reported by ALS patients such as constipation,~     diffuse abdominal pain, and a feeling of fullness or nausea may be attributed to autonomic~     involvement. Toepfer et al. found delayed gastric emptying in most ALS patients, indicating~     autonomic dysfunction (Gastrointestinal dysfunction in amyotrophic lateral sclerosis.~     Amyotrophic Lateral Sclerosis Other Motor Neuron Disord 1999; 1:15—19). The same authors also~     reported markedly prolonged colon transit time in ALS (Toepfer et al: Delayed colonic transit~     times in amyotrophic lateral sclerosis assessed with radio-opaque markers. Eur J Med Res~     1997; 2:473—476).~      The present study will investigate the GI transit time in a large cohort of patients and~     controls using a noninvasive technique that measure hydrogen gas production with the~     digestion of lactulose in a measured substrate load presented to the bowel.~   "
217314|NCT00714792|"~     The purpose of this study is to look for evidence of bacteria in the urine or bladder of~     people with overactive bladder. Because you do not have overactive bladder, your~     participation in this study will be used as a comparison to those who have overactive~     bladder.~   "
217315|NCT00714779|"~     In this study we compare two treatments for major depression - fluoxetine and brief~     psychodynamic psychotherapy. In addition to more traditional outcome measures, we also~     measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main~     hypothesis is that brief psychotherapy is as effective as fluoxetine.~   "
217316|NCT00714766|"~     Heat stress reduces the central blood volume and causes orthostatic intolerance. The~     hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat~     stress.~   "
217317|NCT00714753|"~     RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor~     to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation~     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when~     given with or without external-beam radiation therapy and to see how well it works in~     treating patients with localized prostate cancer.~   "
217318|NCT00714740|"~     The purpose of the study is to investigate the effect of acetazolamide as a treatment for~     sleep related breathing disturbances in patients with the obstructive sleep apnea syndrome~     living at low altitude during a sojourn at moderate altitude~   "
217319|NCT00714727|"~     The object of this research study is to test a standardized set of acupuncture points on~     migraine patients to reduce frequency and intensity of headaches. Acupuncture has been~     studied in prior research but the treatment points have varied between subjects, making it~     difficult to replicate studies.~   "
217320|NCT00714714|"~     A study to compare the skin irritation potential of two marketed gels for acne treatment,~     each applied to half of the face of healthy volunteers.~   "
217321|NCT00714701|"~     CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of~     screening patients with an increased inherited risk for pancreatic cancer.~   "
217322|NCT00714688|"~     The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release~     (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with~     attention deficit/hyperactivity disorder (ADHD).~   "
217323|NCT00714675|"~     The aim of this study is to evaluate the effects of a supplementation of citrulline for three~     weeks in elderly malnourished and hospitalised subjects on muscle protein synthesis.~   "
217324|NCT00714662|"~     To investigate the influence of different dialysis frequencies on the outcome of end-stage~     renal disease patients undergoing chronic hemodialysis therapy.~   "
217325|NCT00714649|"~     Primary diagnose HNSCC carcinoma patients eligible for curative surgery will be proposed the~     addition of 2 or 3 neoadjuvant cetuximab infusions. The main objective is to reduce to a~     minimal delay the time elapsing between last infusion and surgery.~      Iterative biomarkers will be taken at 6 time points permitting to investigate expression gen~     profile and protein mutation.~   "
217326|NCT00714636|"~     The purpose of a CSF repository is to collect samples of spinal fluid from controls and~     patients with neurologic disorders including but not exclusively ALS, Dementia, CRPS,~     neuropathies, and other neuromuscular diseases. This CSF repository will allow the use of CSF~     in biochemical studies of various neurologic diseases. It would also provide a supply of the~     necessary normal and disease control patients. CSF would be obtained from patients who are~     undergoing spinal taps for other reasons including diagnosis, treatment, or participation in~     clinical trials. We are proposing to collect an additional < 3 ml of CSF from a lumbar~     puncture that is already being performed for diagnostic or therapeutic reasons, in order to~     store it in our laboratory for use in future research studies. No lumbar punctures will be~     initiated specifically for this protocol.~   "
217327|NCT00714623|"~     This study is a prospective, non-randomized, open-label registry of consecutive patients with~     CAD treated by stent-assisted PCI using at least one CypherTM stent. Up to 1000 pts will be~     included in the registry. The registry is conducted for the evaluation of the impact of~     CypherTM Sirolimus-eluting stent implantation in the real world of interventional~     cardiology. Informed consent will be obtained from patients meeting the inclusion criteria~     before the initiation of any study specific procedures. Consecutive patients treated with the~     use of the CypherTM stent will be included in the registry. Baseline and post-procedure blood~     samples will be used to perform platelet function analysis using the Accumetrics Ultegra RPFA~     (Rapid Platelet Function Assay).~      All patients will be followed from enrollment through the hospital discharge for any~     clinically significant event (death, myocardial infarction, TLR, TVR, major or minor~     bleeding). A follow-up telephone assessment of death, myocardial infarction,~     revascularization, and medical treatment will be conducted by experienced research personnel~     at 30 days, 6 months, 1 year and at least 2 years. All site reported deaths, myocardial~     infarctions and revascularizations will be adjudicated by an independent Clinical Events~     Committee for all 1000 patients enrolled in the trial. An interim analysis of the first 750~     patients will be conducted and data forwarded to FDA.~   "
217328|NCT00714610|"~     The objective of this study is to compare serum chromium and cobalt levels of patients who~     have undergone metal on metal total hip arthroplasty. It is unknown if the presence of~     bilateral well-functioning large-head metal-on-metal (MOM) total hip arthroplasties (THAs)~     leads to higher serum metal ion concentrations than unilateral MOM THA. Elevated levels~     (chromium, 17 μg/L; cobalt, 19 μg/L) have been associated with poorly functioning MOM THA~     with metallosis. Fourteen patients having undergone bilateral and 25 patients having~     undergone unilateral large-head primary MOM THA were compared. Harris Hip Scores, University~     of California Los Angeles activity scores, radiographs, serum creatinine, and serum cobalt~     and chromium levels were obtained.~   "
217329|NCT00714597|"~     The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.]~     injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the~     primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute~     medical illness.~      The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026~     exposure in this population.~   "
217330|NCT00714584|"~     The purpose of the study is to compare the pharmacokinetics of naltrexone following i.v. and~     oral administration in healthy volunteers, and to assess the bioavailability of naltrexone~     following oral administration. Moreover, safety is assessed.~   "
217331|NCT00714571|"~     Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of~     various forms of dementia, such as Alzheimer's disease and its common precursor mild~     cognitive impairment (MCI). This project intends to assess the efficacy of cognitive~     rehabilitation in these patient populations. We will also use neuroimaging (functional~     magnetic resonance imaging - fMRI) to assess changes in brain activity that occur following~     cognitive rehabilitation.~   "
217332|NCT00714558|"~     The purpose of the study is to compare the pharmacokinetics of fentanyl following i.v. and~     oral administration in healthy volunteers, and to assess the bioavailability of fentanyl~     following oral administration. Moreover, safety is assessed.~   "
217333|NCT00714545|"~     This study is a prospective study of patients treated at Scripps Clinic with intracoronary~     brachytherapy for recurrent restenosis within drug eluting stents.~   "
217334|NCT00714532|"~     This study aims at developing and testing a stage-based scheduled smoking intervention that~     targets to encourage smokers to reduce smoking and to facilitate smoking abstinence. We~     hypothesize that smokers who receive the staged-based scheduled smoking intervention will be~     more likely to report smoking abstinence, quit attempts, and smoking reduction at 12 months.~   "
217335|NCT00714519|"~     This study will assess if a clinical trial regarding healing of partial thickness wounds can~     be executed in nursing homes.~   "
217336|NCT00714506|"~     This research study will assess the effects of two different programs on weight, body~     composition, mobility and improved health. Measures of health will include functional~     abilities, and physical performance. The 2 programs being tested will be provided the same~     physical activity program which will include aerobic activity and resistance (weight)~     training. The intervention study will last up to 1 year with follow-up at 6 months and yearly~     phone calls thereafter.~   "
217337|NCT00714493|"~     The purpose of this study is to assess the effectiveness of treatment in patients with active~     rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment~     with etanercept or adalimumab in addition to methotrexate.~   "
217338|NCT00714480|"~     This study proposes to examine the effect of TMG therapy upon the cellular elements within~     the central (bone marrow) and peripheral (lymph node) lymphoid compartments of humans.~     Briefly, bone marrow aspirates and lymph nodes will be obtained at the time of transplant,~     from renal transplant recipients receiving TMG induction therapy. For comparative purposes,~     peripheral blood samples will also be obtained. Lymphocytes from these compartments will be~     assessed for CD antigen expression, apoptosis, cytokine production following memory immune~     responses, and functional assays to assess potential regulatory T-cell (Treg) activity.~   "
217339|NCT00714467|"~     In this study, we choose to specifically recruit Chinese, the largest ethnic group of the~     Asian and Pacific Islander community,2 as an initial step to increase our understanding of~     the role of family or supportive others in the process of smoking cessation among Asian~     Americans. We propose the following specific aims for the study:~        1. Examine the effectiveness of proactive recruitment of Chinese smokers into a smoking~          cessation treatment program through their family or friends.~        2. Test the efficacy of a family assisted intervention using the stages of change approach~          in promoting smoking cessation in the context of an expert system intervention.~        3. Explore the role of supportive and non-supportive behaviors in relation to both~          short-term and long-term smoking cessation outcomes in the presence of the expert system~          intervention.~   "
217340|NCT00714454|"~     12-week study to compare the efficacy and safety of a course of a twice daily treatment with~     APS in the form of a lotion to its vehicle for the treatment of acne.~   "
217341|NCT00714441|"~     To date, there have been few practical, evidenced based interventions that are directed at~     patients with Type II Diabetes who are experiencing depressed and/or emotional distress in~     primary care settings. This study will (1) combine two existing, evidenced-based,~     interventions (a computer automated, diabetes specific self-management program (CASM) vs. a~     self-care program plus a live problem solving distress-reduction program (CAPS) vs. a~     lifestyle and activities education program (LEAP-AHEAD)) into a practical, 3-arm clinical~     trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the intervention~     using the RE-AIM framework, sharing the results through a comprehensive dissemination~     package.~      Hypothesis 1: The combined CASM and CAPS arms will be superior to the LEAP-AHEAD group on the~     primary outcomes at follow-up.~      Hypothesis 2: The CAPS arm will be superior to the CASM arm on primary outcomes at follow-up.~   "
217342|NCT00714428|"~     Objectives: The ultimate goal of this research program is to promote seamless, comprehensive~     care for Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) veterans. The purpose~     of this study is to develop a psychometrically sound tool to measure health-related quality~     of life (HRQOL) applicable to wounded warriors with TBI (deployment-related TBI).~   "
217343|NCT00714415|"~     The purpose of this observational study is to describe the incidence of adverse events among~     patients treated with BeneFix® in usual health care settings in Germany.~   "
217344|NCT00714402|"~     The purposes of this study are:~        1. To determine whether procalcitonin level at admission of pediatric patients with~          bacterial infections can be used as a marker for prediction of defervescence and~          hospitalization length~        2. To examine the kinetics of procalcitonin in pediatric patients with bacterial infections~          and persistent fever~   "
217345|NCT00714389|"~     The goal of this study to determine normal values for certain urinary measurements in order~     to better understand voiding dysfunction in women.~   "
217346|NCT00714376|"~     The purpose of this study is to assess the response to Taxotere (docetaxel) chemotherapy~     given as a primary treatment to patients with early and rapid PSA rising after prostatectomy~     for high risk disease.~   "
217347|NCT00714363|"~     The objective of the study is to compare clinical outcomes from LASIK and SBK using~     FDA-approved laser technology on the same patient~   "
217348|NCT00714350|"~     Our objective is to develop intuitive, meaningful and ergonomically efficient informative~     displays specific to the user's domain. Specifically we aim to enhance and refine the display~     prototype of ABG information to include gas-exchange, acid-base balance, lung mechanics,~     ventilation, oxygenation, and metabolism information.~   "
217349|NCT00714337|"~     To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to~     the AZD1386 oral solution.~   "
217350|NCT00714324|"~     The purpose of this study is to determine if patients are able to reliably screen themselves~     for nutrition risk.~   "
217351|NCT00714311|"~     The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is~     effective in the treatment of Borderline Personality Disorder.~   "
217352|NCT00714298|"~     Early diagnostic of non ST elevation coronary syndrome in patients admitted to the emergency~     room is difficult. Two news biochemical markers have been assessed and studies have suggested~     that heart fatty binding protein and ischemia modified albumin are early markers of~     myocardial necrosis and myocardial ischemia. The aim of the study is to analyse the~     predictive value of association of heart fatty binding protein and ischemia modified albumin~     for non ST segment elevation acute coronary syndrome diagnosis in the first hour of~     management in the emergency room.~   "
217353|NCT00714285|"~     The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza~     vaccine candidate compared to a licensed trivalent influenza vaccine in adults.~   "
217354|NCT00714259|"~     A non-myeloablative treatment strategy and uniform selection criteria will enable patients~     with a variety of low grade B-Cell malignancies to attain long term disease control without~     unacceptably high treatment related mortality.~   "
217355|NCT00714246|"~     This is a phase I/II study. The phase I portion of the study will determine the maximum~     tolerated dose of bortezomib when administered in combination with carboplatin & docetaxel~     and to determine the efficacy of the combination for patients with advanced NSCLC. Phase II~     will determine time to progression and overall survival and determine changes in serum~     proteomics patterns before & after combination therapy.~   "
217356|NCT00714233|"~     A 24 week study to compare the use of Metformin, birth control pills and a carefully planned~     intensive lifestyle program that includes weight loss and exercise. These approaches will be~     compared to placebo (a pill that contains no active substances. Metformin, birth control~     pills and the lifestyle management program will be used on this research study to compare~     their ability to:~        1. reduce fasting glucose levels~        2. reduce androgen hormone levels~        3. improve sex steroid binding, and~        4. improve lipids (fatty substances in the blood)~   "
217417|NCT00713440|"~     The purpose of this study is to evaluate whether the reduced incretin effect and the~     paradoxical glucagon responses during oral glucose ingestion and isoglycaemic iv glucose~     infusion observed in patients with type 2 diabetes are causes (non-inducible in lean healthy~     subjects without family history of diabetes) or consequences (inducible) of the diabetic~     state.~   "
250437|NCT00274131|"~     To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI~     Sifrol®) in Parkinson's disease (phase III study).~   "
217357|NCT00714220|"~     The work of Nau et. al (Nau KL, Bromberg MB, Forshew DA, Katcha Vl. Individuals with~     amyotrophic lateral sclerosis are in caloric balance despite losses in mass. J Neurol Sci~     1995;129 :47-49) showed that patients in the early stages of ALS initially increase their~     body fat. Another study showed that advanced ALS patients on mechanical ventilation were~     actually hypometabolic, supporting a hypothesis that ALS patients' daily oral intakes of~     calories fail to match their energy requirements, thus exacerbating their condition. This~     current study investigates and compares substrate utilization using a metabolic cart in~     controls and in ALS patients who are on and off ventilatory support to examine differences in~     substrate utilization between the two groups of ALS patients and the controls. (Substrate~     utilization is essentially the percentage of fats, carbohydrates, and protein utilized by the~     body.) The study will increase our understanding of the nutritional needs of ALS patients and~     improve our ability to provide the best possible nutrition in progressive illness.~   "
217358|NCT00714207|"~     The purpose of this study was to determine if a school-based multi-session group smoking~     cessation program is more effective than a single session group program.~   "
217359|NCT00714194|"~     This is an intervention study whose purpose is to determine whether daily interruption of~     sedative infusion contributes to the reduction of the occurrence of delirium and improves~     sleep perception in critically ill patients. Patients in a trauma intensive care unit (TICU)~     receiving mechanical ventilation and continuous infusion of sedatives will be enrolled in the~     study. A patient will be entered into the study after the family member has consented to have~     the patient participate.~   "
217360|NCT00714181|"~     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of hydroxychloroquine~     when given together with temozolomide in treating patients with metastatic or unresectable~     solid tumors.~   "
217361|NCT00714168|"~     The number of overweight and obese adults in the United States is increasing at a rapid rate.~     A stepped-care weight loss program, which at key times increases the frequency of contact~     between an individual trying to lose weight and the program staff, may be beneficial for~     achieving long-term weight loss. This study will compare a standard behavioral weight loss~     program with a stepped-care weight loss program in their abilities to help people who are~     overweight or obese to lose weight.~   "
217362|NCT00714155|"~     The purpose of this study is to evaluate the long-term success rate of the colpocleisis~     procedure and its effect on quality of life in women who have this surgery. We want to see if~     women who have this surgery have problems with recurrent pelvic organ prolapse, urinary~     incontinence, or bowel problems after the surgery. We also want to see how the surgery~     affects women's sexuality.~   "
217363|NCT00714142|"~     Two investigational chemical tracers, 62Cu-ethylglyoxal bis(thiosemicarbazone) (62Cu-ETS) and~     15O-water, will be used in this study to look at how blood moves through the kidneys. The~     purpose of the study is to see if 62Cu-ETS is effective in showing the blood supply to the~     kidneys compared to 15O-water. The tracer mixes with the blood and moves through the body.~     Using positron emission tomography (PET scan) the researchers can see the tracer and can~     learn more about how the blood moves through the kidneys. The study invites participants who~     are healthy, without any heart or kidney disease, patients who have kidney disease that~     require dialysis, and patients who may have a blockage in one of the arteries supplying blood~     to the kidneys.~   "
217364|NCT00714129|"~     The worldwide epidemic of obesity is paralleled with increased cases of non-alcoholic liver~     disease (liver fat accumulation) and diabetes. Fat belongs in the adipose tissue, and if~     excess fat accumulates in the liver or muscle, these tissues cannot use sugar efficiently. It~     has been discovered that when large quantities of fructose (a sugar present in soft drinks)~     are consumed, the conversion of carbohydrate (CHO) to fat in the liver increases.~      We hypothesize that: 1) subjects with fatty liver have a higher CHO uptake and conversion to~     fat in their liver when compared to matched control subjects with normal liver fat content;~     and that: 2) when subjects with fatty liver are fed a diet limiting fructose and simple~     sugars will decrease their liver CHO fat content. This reduction in liver fat will normalize~     the way the liver responds to sugar and insulin, reversing the pre-diabetic state.~      The measurement of these parameters will be done using state-of-the-art techniques such as~     safe non-radioactive isotope tracers and non-invasive magnetic resonance spectroscopy.~      For more information, please call 415-206-5532 for a phone screening~   "
217365|NCT00714116|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK),~     and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).~   "
217366|NCT00714103|"~     The goal of this clinical research study is to find the highest safe dose of the drug~     8-chloro-adenosine that can be given in the treatment of chronic lymphocytic leukemia (CLL).~     Another goal is to learn how effective the drug is at treating leukemia.~   "
217367|NCT00714090|"~     The purpose of this study is to assess the efficacy of add-on therapy with repetitive~     Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive~     disorders compared to venlafaxine only (the optimal medication) and to rTMS only.~   "
217368|NCT00714077|"~     The purpose of this study is:~        -  To compare the long-term of survival and local/regional control between the two~          postoperative concurrent chemoradiotherapy regimens: capecitabine vs. oxaliplatin and~          capecitabine,for stage II and III rectal cancer~        -  To compare the toxicity profile between the two different concurrent chemoradiotherapy~          regimens.~   "
217418|NCT00713427|"~     This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to~     collect data to support regulatory clearance by the FDA in the United States and to determine~     the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment~     for malignant bile duct obstruction.~   "
217459|NCT00712881|"~     Evaluate the efficacy and safety of treatment with MYOCET® in combination with~     Cyclophosphamide and Trastuzumab, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles,~     in women with stage II or III breast cancer whose tumour overexpresses the HER2 gene.~   "
217460|NCT00712868|"~     To demonstrate the safety and acceptability of the gynaecological formulation.~   "
217369|NCT00714064|"~     PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination~     for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can~     prevent ear disease in infants. Mothers will receive the 23 valent pneumococcal~     polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon~     after child birth; or c) seven months after child birth (control group). The adult~     diphtheria, tetanus and acellular pertussis vaccine (dTpa) will be used as the control~     vaccine for the birth dose.~      The study aims to recruit 210 Indigenous women aged 17-39 years who have an uncomplicated~     pregnancy. Following recruitment, subjects will be randomly assigned to one of the three~     groups.~      Each mother and infant will be followed from pregnancy until the baby is seven months of age.~     All routinely recommended vaccinations on the standard vaccination schedule will continue to~     be offered by the subject's vaccine provider in accordance with current clinical practice.~      The primary outcome will be prevalence of middle ear disease at seven months of age, defined~     as middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic~     otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary~     analyses will be a direct comparison of the proportion of infants in the control group who~     have nasopharyngeal carriage of one or more vaccine type pneumococci at seven months of age~     compared to infants in each of the other two groups. A similar comparison of the proportion~     with middle ear disease will be undertaken between the control group and the respective~     intervention group.~   "
217370|NCT00714051|"~     The purpose of this study is to test the effectiveness of a fall prevention program for older~     adults. Participants assigned to the intervention group will train weekly on a special~     treadmill that will simulate tripping. Patients not assigned to the tripping program will~     walk on a standard treadmill.~   "
217371|NCT00714038|"~     Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice~   "
217372|NCT00714025|"~     An open-label, single arm, non-randomized, single stage phase II study. 3 phases:Baseline,~     treatment/duration and Follow-up. All patients will be treated with RAD001 10 mg daily dose~     until disease progression or unacceptable toxicity death, or discontinuation from the study,~     for any other reason~   "
217373|NCT00714012|"~     Our objective is to develop intuitive, meaningful and ergonomically efficient informative~     displays specific to the user's domain.~   "
217374|NCT00713999|"~     A cross-sectional study of urogenital schistosomiasis and sexually transmitted infections~     (STI) prevalence and associated morbidity in a rural community in Madagascar. Clearance of~     infections and resolution of morbidity were subsequently studied in two phases following~     systematic anti-STI and anti-schistosoma treatment, respectively.~   "
217375|NCT00713986|"~     Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This~     study objective is to test the efficacy regarding pain attenuation of 3 interventions~     (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus~     control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at~     48-72 hours of life.~   "
217376|NCT00713973|"~     Background: Compare the American and Brazilian protocols for prophylaxis of deep vein~     thrombosis (DVT), seeking to draft a new protocol, more comprehensive and applicable.~     Methods: A prospective study was conducted over a year, covering 212 patients, comparing the~     protocols on the stratification of risk of DVT, and the type of prophylaxis indicated. A new~     protocol was proposed, applied and compared to previous.~   "
217377|NCT00713960|"~     Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice~   "
217378|NCT00713947|"~     Low dose of aspirin is the main cause of gastro-duodenal ulcer. The best prevention is not~     definite particularly in patients without history of ulcer and infected by H. pylori.The aim~     of the study is to evaluate the gastric damage induced by aspirin in patients with H. pylori~     infection but who have any history of ulcer.~   "
217379|NCT00713934|"~     Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is~     one of the only effective therapies available to such patients. However, lack of donors,~     surgical complications, rejection, and high cost are it`s serious problems. The potential for~     stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently~     confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases,~     and several clinical studies have applied BMC injection to induce regeneration of myocardium~     and blood vessels. In this study we will evaluate safety and feasibility of autologous bone~     marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation~     through the portal vein in patients with decompensate cirrhosis.~   "
217380|NCT00713921|"~     Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke~   "
217381|NCT00713908|"~     The purpose of this study is to evaluate how often women have problems passing their urine~     (voiding) after TVT (Tension Free Vaginal Tape) surgery. This will help us to better~     understand normal voiding function after surgery as well as to find factors that may help us~     predict who will have problems after surgery.~   "
217382|NCT00713895|"~     The research study examined the feasibility, implementation, and efficacy of the interactive~     expert system intervention for smoking cessation in the Chinese American population.~   "
217383|NCT00713882|"~     The aims and objectives of this research are to identify chronic health conditions,~     psychological disease, quality of life issues, and patient preferences for survivorship care~     in patients who have survived aggressive lymphoma.~      Subjects will be asked to participate in an oral interview with the primary investigator,~     either in-person or over the telephone. It is estimated that the survey will take about an~     hour.~   "
217434|NCT00713206|"~     This prospective, randomized-controlled, clinical study evaluates the ability of the NanoTite~     implant system to achieve integration and provide long-term support of a prosthesis when~     placed immediately in fresh sinus augmentation material. Control cases will be those where~     the sinus augmentation material is allowed four months of healing prior to NanoTite implant~     placement. In addition to implant performance, radiographic evidence of crestal bone~     regressive modeling will be used to evaluate differences between test and control cases.~      Study (null) hypothesis: The implants placed into sinus augmentation sites at the time of~     grafting will have the same integration success and maintenance of integration as for the~     implants placed after four months of graft healing.~   "
217384|NCT00713869|"~     Over the past several decades, considerable effort has been expended toward the successful~     cryopreservation of various human cells. While attempts at cryopreservation have been~     directed at different tissue types, one of the most vigorously pursued targets has been~     reproductive tissue. Historically, cryopreservation of human sperm has existed for several~     decades. The earliest reports of pregnancies (Trounson et al., 1983) and births (Zeilmaker et~     al., 1984) from the cryopreservation of human embryos occurred in the early 1980s. Presently,~     the freezing and storage of human embryos following in vitro fertilization (IVF) is standard~     practice at most fertility clinics. In 2003, the CDC Assisted Reproductive Technology success~     rates report stated that 4,246 live births occurred out of 17,517 non-donor frozen embryo~     cycles. . Because the human egg is a relatively voluminous cell with abundant cytoplasm,~     crystallization at the time of freezing may result in damage to the organelles. Secondly, a~     mature metaphase II oocyte contains a fragile spindle apparatus involved in cleavage.~      The purpose of this research study is to evaluate a method of freezing and thawing oocytes.~     This evaluation will be made by comparing the survival rates and rates of fertilization,~     cleavage and embryo quality of fresh oocytes and frozen-thawed oocytes which will be~     inseminated during the IVF (in vitro fertilization) treatment cycle. In addition, the same~     comparisons will be made between frozen oocytes from infertile women and those of egg donors.~     You are being asked to be in this study because you are currently undergoing in vitro~     fertilization.~   "
217385|NCT00713856|"~     The study objective is to compare the clinical outcomes using wavefront guided PRK with iris~     registration and conventional laser PRK using FDA-approved laser technology on the same~     patient.~   "
217386|NCT00713843|"~     Background of the study: Manual Therapy applied to patients with non-specific neck pain has~     been investigated several times, both internationally and nationally. In the Netherlands~     different types of manual therapy treatment exist. Manual Therapy, as practiced under the~     Utrecht School, has not been subject of a randomized controlled trial. There is a need to~     evaluate the effectiveness of this type of manual therapy.~      Objective of the study: This trial will investigate the effectiveness of Manual Therapy in~     the short and long-term up to 52 weeks in patient with (sub) acute (minimal two weeks) and~     chronic (maximum 52 weeks) since last episode of neck pain. Functional state, pain and global~     perceived effect are the outcome variables.~      Study design: The study is a single blind randomized controlled trial.~      Study population: Men and women aged 18 to 70 years old with neck pain for at least two~     weeks.~      Intervention: The experimental group will be treated with manual therapy for a period of six~     weeks. The control group will be treated with physical therapy (usual care) also for a period~     of six weeks.~      Primary study parameters / outcome of the study: Global Perceived Effect (GPE) and the Neck~     disability index (NDI-DV ) will be applied.~      Secondary study parameters / outcome of the study: Visual Analogue Scale (VAS) for pain and~     SF36 (Quality of life). The Multidimensional Health Locus of Control(MHLC ),~     Credibility/Expectancy Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ-DLV) will~     also be measured.~   "
217387|NCT00713830|"~     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in~     comparison to placebo, as an add-on treatment to sulfonylurea without or with metformin, over~     a period of 24 weeks of treatment, followed by an extension.~      The primary objective is to assess the effects of lixisenatide when added to sulfonylurea~     with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c)~     reduction (absolute change) at Week 24.~      The secondary objectives are to assess the effects of lixisenatide on percentage of patients~     reaching HbA1c less than (<) 7 percent (%); percentage of patients reaching HbA1c less than~     or equal to (<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed~     by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG),~     glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a~     sub-study in all patients in selected centers; to evaluate safety, tolerability,~     pharmacokinetics (PK) and anti-lixisenatide antibody development.~   "
217388|NCT00713817|"~     The purpose of this study is to assess the maintenance of effect after long-term treatment of~     Sativex® in subjects with neuropathic pain.~   "
217389|NCT00713804|"~     People who have experienced mental illnesses like schizophrenia, bipolar disorder or~     schizoaffective disorder often have a poor understanding of the causes of their illness, and~     that they are often very worried about how the illness affects their families. In particular,~     affected individuals worry that there is a high chance that any children that they have will~     become affected with the same illness. Often, because of this fear, affected individuals~     choose not to have children.~      Genetic counseling is a process where information about the causes of illnesses, and about~     chances for family members of individuals with these illnesses to become similarly affected~     is provided in a supportive environment by a specially trained healthcare professional. This~     study will investigate whether genetic counseling can reduce perceptions of risk and stigma,~     and increase perceived control and knowledge about the causes of the illness, amongst~     individuals who have a major mental illness.~   "
217390|NCT00713791|"~     This study is designed to see how different formulations of ZD4054 (Zibotentan) are absorbed~     by the body. As for all clinical trials, safety and tolerability of the drug will be~     evaluated.~   "
217391|NCT00713778|"~     The purpose of this study is to investigate the impact of electrocoagulation on ovarian~     reserve after laparoscopic excision of ovarian cyst and the possible mechanisms.~   "
217392|NCT00713765|"~     The aims of this study are to 1) examine the effects of AZD3480 and donepezil on the blood~     concentrations of each other and 2) assess the safety and tolerability of the combined~     administration of AZD3480 with donepezil.~   "
217393|NCT00713752|"~     The purpose of this study is to establish normal values for neuropsychological testing in HIV~     negative Thais stratified by age (1 decade) and education (no certificate or primary school~     certificate, less than high school certificate or vocational certificate, high school~     certificate or higher vocational certificate or diploma, Bachelor degree or higher.~   "
217435|NCT00713193|"~     This research involves the use of immune base therapy as an adjunct to plasma exchange, the~     present standard of care for thrombotic thrombocytopenic purpura (TTP). Funding source -FDA~     OOPD~   "
217461|NCT00712855|"~     The purpose of this study is to evaluate the safety and tolerability of escalating doses of~     mapatumumab in combination with sorafenib in subjects with advanced Hepatocellular Carcinoma~     who are positive for hepatitis B surface antigen or hepatitis C antibody.~   "
217394|NCT00713739|"~     The goal of this study is to conduct a prospective controlled trail of four currently~     approved Department of Defense (DOD) - formulary medications for use as medical expulsion~     therapy (MET) for kidney stones. Between 8% and 15% of Americans will develop symptomatic~     urolithiasis in there life. Several medications, including steroids, calcium channel~     blockers, alpha-adrenergic antagonists and non-steroidal anti-inflammatory drugs, have been~     utilized to aid in the spontaneous passage of distal ureteral calculi. Recently, use of~     selective alpha-blockers has shown promise for medical expulsion therapy (MET) of distal~     ureteral calculi. None of these studies have been widely publicized outside the specialty of~     urology. Recent studies have shown a success rate of nearly 90% when the selective~     alpha-blocker tamsulosin (Flomax) was used for MET. MET has also been shown to result in a~     decreased narcotic requirement, shorter time to stone passage, and reduced requirement for~     further interventions. The investigators will evaluate the effectiveness of MET as initial~     management for kidney stones using DOD-approved formulary medications.~   "
217395|NCT00713726|"~     In newborn infants submitted to surgical procedures, tramadol may provide an effective~     analgesia and decrease the time on mechanical ventilation support and the time to achieve~     full enteral feeding.~   "
217396|NCT00713713|"~     Mechanical ventilation with low tidal volume (about 6 ml.kg-1) reduces mortality in ALI/ARDS~     patients respect to high tidal volume ventilation (about 12 ml.kg-1).~      This finding is usually explained by alveolar tidal overdistension associated to high tidal~     volume. Stretch-induced lung injury may trigger a cytokine-mediated inflammatory response.~     This may contribute to the development of systemic inflammatory response and multiple system~     organ failure and death.~      High tidal volume strategies might affect organ function by pathways not mediated by~     inflammatory response.~      It is well recognized the inverse relationship between tidal volume and cardiac output during~     mechanical ventilation. Nevertheless there are no clinical studies about cardiac output~     changes induced by low (6 ml.kg-1) and high tidal volume (12 ml.kg-1) in ALI/ARDS patients.~      The study hypothesis is that high tidal volume ventilation reduces cardiac output in ALI/ARDS~     patients respect to low tidal volume strategy. Thereafter reduced hemodynamic impact could~     explain beneficial effect of low respect to high tidal volume ventilation.~      If study hypothesis is confirmed, other studies should define the main cause of mortality~     reduction related to low tidal volume strategies and if appropriate hemodynamic monitoring~     and support should be required when low tidal volume strategies are harmful (i.e. traumatic~     brain injury).~   "
217397|NCT00713700|"~     The objective of this study is to investigate the safety and effectiveness of the ADO II in~     patients with a PDA.~   "
217398|NCT00713687|"~     In patients with cholangiocarcinoma therapeutic effects have been reported for~     Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved~     patients survival in two randomised trials. PDT induces tumor necrosis only in an area of few~     millimetres, while tumor parts which are located beyond this area remain untreated. An~     additive effect could result from PDT as a local therapy in combination with systemic~     chemotherapy.~   "
217399|NCT00713674|"~     The purpose of this study is to examine treatment method of Methicillin-resistant~     Staphylococcus aureus (MRSA) decolonization in patients.~   "
217400|NCT00713661|"~     The primary objective is to evaluate if the application of TachoSil® on a colorectal~     anastomosis is feasible and safe.~      The secondary objective is to establish and describe optimal application methods to be used~     for educational purposes in future trials.~   "
217401|NCT00713648|"~     The trial is conducted in Europe, North America and Asia. The aim of this trial is to~     evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited~     FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of~     bleeding episodes.~   "
217402|NCT00713635|"~     The purpose of this study is to investigate the prenatal impact of abnormal cardiac structure~     on neurodevelopmental outcomes in children with congenital heart disease.~   "
217403|NCT00713622|"~     Zonisamide (Zonegran) and sodium valproate (Epilim) are both medicines approved to treat~     epilepsy. The purpose of this study is to find out the extent to which zonisamide may affect~     memory and concentration, compared to sodium valproate.~   "
217404|NCT00713609|"~     Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative~     for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a~     combination product including these actives for the treatment of acne vulgaris.~      You may be suitable to take part in this study because you have acne vulgaris on your face.~     Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms,~     legs, and back.~   "
217405|NCT00713596|"~     The purpose of this study is to determine whether the use of fibrin glue during nasal surgery~     leads to a shorter recovery period with less bruising and/or swelling.~   "
217406|NCT00713583|"~     Cocaine dependence is a major public health problem and the development of a treatment for~     this disorder is a priority. To date, treatment interventions based on positive incentive~     principles have shown the strongest effects for improving substance use outcomes. One such~     example is contingency management (CM) interventions in which nondrug rewards are used to~     compete with cocaine. Recent evidence suggests that certain medications improve response to~     CM interventions, particularly agents that target dopamine reward systems in the brain. A~     promising dopamine-enhancing medication is levodopa. The study team has observed the~     strongest effects of levodopa when the medication is administered in the context of CM~     therapy, perhaps through mechanisms that enhance reward saliency. The proposed study is~     designed to further evaluate this promising treatment approach. Cocaine dependent outpatients~     will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical~     trial. CM will be behavioral therapy platform for both treatment groups. The study will test~     the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing~     cocaine use. This study is expected to validate the usefulness of a new~     behavioral-pharmacological treatment approach for cocaine dependence.~   "
217456|NCT00712920|"~     The purpose of this study is to determine if two allergy medications are more effective than~     placebo.~   "
217472|NCT00712712|"~     RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to~     remove bone metastases.~      PURPOSE: This phase II trial is studying how well morphine works after radiofrequency~     ablation of painful bone metastases in patients with cancer.~   "
217407|NCT00713570|"~     Genetic research has provided the most exciting breakthroughs in neuroscience and cognitive~     science. Partially genetically determined cognitive impairments have been described in people~     with COMT, 5HT6, BDNF (Swillen et al., 2000; Moss et al., 1999, Henry et al., 2002, Bilder et~     al., 2002)and biological systemic pathway candidate genes.~      Selective inhibitors of COMT proved to improve cognitive function in animals and in patients~     with Parkinson's disease (Carlsson, et al, 2000). Recent studies suggested that variation in~     COMT activity might have neurobiological effects specific to the prefrontal cortex; the COMT~     (Val) allele with high activity impairs tasks of prefrontal cognition in people with~     schizophrenia (Egan et al., 2001) and higher loading of the COMT (Met) allele is associated~     with better cognitive performance on attention and processing speed in people with chronic~     schizophrenia (Bilder et al., 2002). Moreover, prefrontal dopamine levels are increased in~     COMT knockout mouse model (Gogos et al., 1998). This suggests that in people who have~     heterozygosis on COMT, dopamine levels could be abnormal. Thus, variation in COMT expression~     could also affect performance on prefrontal cognitive tasks. In the previous study, we found~     the neuropsychological profile in students with COMT (Met) allele is better in object~     perception, problem solving and planning, and abstract and social thinking (Henry et al.,~     2002).~      5-HT6 inhibitor has been reported to raise extracellular acetylcholine levels in the cortex~     and hippocampus (Dawson et al., 2001 and Riemer et al., 2003). Acetylcholine release in~     hippocampal and cortical regions is known to be important for memory acquisition and~     retention, and several groups have demonstrated that 5-HT6 blockade overcomes~     scopolamine-induced amnesia. We hypothesize that variations in COMT and 5-HT6 are associated~     with genotype that will cause a poor/better performance in cognitive tasks.~      With the aim to establish the possible correlation between candidate genes (COMT, 5HT6,BDNF~     and biological systemic pathway candidate genes. etc) and cognitive ability, which will~     provide us an understanding on factors and its extent that affect students' thinking, and~     then develop appropriate teaching models or strategies for assisting students in learning. It~     seems timely, therefore, to consider how we might implement our increased understanding of~     brain development and brain function to explore educational questions.~   "
217408|NCT00713557|"~     SRACE is an multicenter observational database of outcomes for patients who are hospitalized~     with an acute coronary events. SRACE includes over 20 hospitals in Shanghai China that have~     enrolled a total of more than 3,000 patients since 2005, with an annual enrollment of 500~     patients. The major purpose of the SRACE program is to evaluate the prognosis of patients~     admitted to the hospital due to acute coronary events, comparing different therapeutic~     strategies, in-hospital transferring system, and so on. All participating physicians receive~     confidential quarterly reports showing ther outcomes side-by-side with the aggregate outcomes~     of all participating hospitals.~   "
217409|NCT00713544|"~     This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid~     Arthritis (RA) and if so how it compares to placebo (a substance which does not have any~     action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when~     added to treatment with methotrexate. The purpose of this study is also to find out which~     dose of AZD5672 is the most effective at treating RA and to find out how well the body~     tolerates AZD5672 when taken for up to 12 weeks.~   "
217410|NCT00713531|"~     The purpose of this study is to assess populations in Thailand at high risk for HIV-1~     infection for potential efficacy trials of candidate HIV vaccines to include:~        1. assess incidence of HIV-1 and volunteer retention~        2. describe early viral load and CD4 counts~        3. assess participant willingness to participate in HIV vaccine efficacy trials and other~          HIV prevention trials~        4. describe volunteer risk behavior~   "
217411|NCT00713518|"~     The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of~     neovascular/wet AMD and at which dose.~   "
217412|NCT00713505|"~     RATIONALE: An educational and skills training program for the parent of a childhood cancer~     survivor with neurobehavioral dysfunction may help improve the child's school performance,~     thinking ability, and behavior.~      PURPOSE: This randomized clinical trial is studying an educational and skills training~     program for parents of childhood cancer survivors who have neurobehavioral dysfunction.~   "
217413|NCT00713492|"~     This study will test the reliability of a procedure for self-administering ethanol (alcohol)~     intravenously (through a vein), using a computer-assisted method. People ordinarily~     self-administer alcohol through drinking alcoholic beverages, but blood alcohol levels~     resulting from drinking vary greatly among individuals. For research on alcohol dependence~     and treatment, a tool for achieving precise blood levels is needed. In addition to testing~     this method of alcohol administration, the study will examine self-administration behavior~     and resulting breath alcohol concentration, the effects of alcohol on the participants, and~     differences between men and women in alcohol self-administration.~      Healthy normal volunteers between 21 and 45 years of age may be eligible for this study.~     Participants are assigned to one of two study groups. Group 1 undergoes three 7-hour study~     sessions and group 2 participates in two sessions, each of which includes the following~     procedures:~        -  Breathalyzer and urine tests for alcohol and illicit drug use.~        -  Urine pregnancy test for women.~        -  Light lunch.~        -  Questionnaire about health and recent drinking.~      Alcohol infusion: Subjects are seated in a comfortable chair and instructed on how to use a~     computer to give themselves a short infusion of alcohol through a catheter (plastic tube)~     that has been inserted into a vein in their the arm. Sensors are placed on their chest to~     monitor heart beat and their neck to record skin blood flow. At the start of the session,~     subjects complete questionnaires about any drug effects and urges to drink they may be~     feeling. They are trained on how to use the computer to administer alcohol and are then~     allowed to self-administer alcohol through the catheter any time they like, as long as their~     peak breath alcohol level does not exceed 0.1 g% (a level that would result from ingestion of~     4 to 6 drinks in most people). If that point is reached, the computer automatically~     inactivates self-administration until the level is lowered again. Breathalyzer readings are~     taken every 15 to 30 minutes. Subjects may read, watch television or videos or listen to~     music during the sessions.~      Recovery: At the end of the 2.5 hours of self-administration, the catheter is removed and~     subjects can eat, read, watch television and relax in the clinic until their breath alcohol~     level falls below 0.02 g%, usually after 2.5 to 3 hours, when they can go home by taxi or~     with a pre-arranged designated driver.~   "
217414|NCT00713479|"~     More people worldwide use amphetamine-type stimulants than any illicit drug besides cannabis,~     and methamphetamine (MA) abuse and dependence is the fastest growing drug problem in the~     United States. Much work remains in identifying an effective pharmacotherapy for MA~     dependence. The neurobiological actions produced by MA involve dopamine (DA), serotonin, and~     norepinephrine, but also include alterations to cholinergic neurotransmitter systems.~     Candidate compounds that target acetylcholine (ACh) are attractive options for development~     that have not received adequate attention. Varenicline is a drug that increases the release~     of DA in the brain and it is logical to assume that it would to some extent compensate for~     the reduction in these neurotransmitters that occurs in MA withdrawal.~      Current research has linked certain genes that are related to neurotransmitters with drug~     abuse and memory impairment (e.g., A1 allele for the D2 dopamine receptor and~     catechol-O-methyltransferase). We will take blood samples and test for these genes in order~     to relate the findings to brain function.~      This is a double-blind, placebo-controlled, within-subjects study to determine the safety and~     tolerability of MA in MA-dependent volunteers treated with varenicline and placebo.~   "
217415|NCT00713466|"~     The purpose of this study is to determine if utilizing CLIPP (Computer-Assisted Learning~     Pediatrics Program) cases in the pediatric clerkship will standardize students' exposure to~     essential pediatric conditions and enhance their learning experience.~   "
217416|NCT00713453|"~     This study is to study the response of muscle cells from Pompe disease after enzyme~     replacement therapy~   "
217419|NCT00713414|"~     This study will examine how the brain controls speech in patients with spasmodic dysphonia, a~     voice disorder that involves involuntary spasms of muscles in the larynx (voice box), causing~     breaks in speech. Although the causes of spasmodic dysphonia are unknown, recent studies~     found changes in brain function in patients with the disorder that may play a role in its~     development.~      People between 21 and 80 years of age with adductor spasmodic dysphonia may be eligible for~     this study. Candidates are screened with the following procedures:~      Medical history and physical examination.~      Nasolaryngoscopy to examine the larynx. For this test, the inside of the subject s nose is~     sprayed with a decongestant and a small, flexible tube called a nasolaryngoscope is passed~     through the nose to the back of the throat to allow examination of the larynx. The subject~     may be asked to talk, sing, whistle and say prolonged vowels during the procedure. The~     nasolaryngoscope is connected to a camera that records the movement of the vocal cords during~     these tasks.~      Voice and speech recording to measure the type and severity of voice disorder. Subjects are~     asked questions about their voice disorder and their voice is recorded while they repeat~     sentences and sounds.~      Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI)~     of the brain, as follows:~      PET: A catheter is placed in a vein in the subject s arm to inject a radioactive substance~     called a tracer that is detected by the PET scanner and provides information on brain~     function. [11C]flumazenil is used in one scanning session and [11C]raclopride is used in~     another. For the scan, the subject lies on a bed that slides in and out of the~     doughnut-shaped scanner, wearing a custom-molded mask to support the head and prevent it from~     moving during the scan. For the first scan the subject lies quietly for 60 minutes. For the~     second scan, the subject lies quietly for 50 minutes and is then asked to say sentences~     during another 50 minutes. The amount of radiation received in this study equals to a uniform~     whole-body exposure of 0.9 rem, which is within the dose guideline established by the NIH~     Radiation Safety Committee for research subjects. The guideline is an effective dose of 5 rem~     received per year.~      MRI: This procedure uses a strong magnetic field and radio waves instead of X-rays to obtain~     images of the brain. The subject lies on a table that slides into the scanner, a narrow metal~     cylinder, wearing ear plugs to muffle loud knocking sounds that occur during the scan. Images~     of the brain structure are obtained while the subject lies still in the machine for 10~     minutes. This is followed by functional MRI (fMRI) for 60 minutes, in which pictures are~     taken while the subject speaks, showing changes in brain regions that are involved in speech~     production.~   "
217420|NCT00713401|"~     Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels~     when given alone and in combination with a beta-blocker (esmolol) in patients with atrial~     fibrillation to control rapid heart rate. Explore the pharmacokinetic and pharmacodynamic~     effects when given alone and in combination with beta-blocker (esmolol).~   "
217421|NCT00713375|"~     Dysregulation of autonomic nervous system is evident in patients with spontaneous~     intracranial hemorrhage. In this study, we utilize a non-invasive method (heart rate and~     blood pressure variability analysis to analyze the autonomic activities in this group of~     neurosurgical patients. Our aim is to determine the utility of this modality in risk~     stratification and outcome prediction in these patients.~   "
217422|NCT00713362|"~     We hypothesize that VATS is more effective than CTD for management of primary spontaneous~     pneumothorax with aspiration failure. To this end, we will compare two groups of patients who~     had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by~     treatment.~   "
217423|NCT00713349|"~     The objective of the study is to compare the healing of wounds induced by cryo-injury when~     treated with white petrolatum versus an ointment vehicle.~   "
217424|NCT00713336|"~     This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a~     positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer~   "
217425|NCT00713323|"~     The purpose of this study is to assess the safety and tolerability of long term therapy with~     Sativex® in relieving neuropathic pain.~   "
217426|NCT00713310|"~     The overall objective of this study is to assess the safety and efficacy of high dose and low~     dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks~     to children and adolescents with mildly-to-moderately active ulcerative colitis.~   "
217427|NCT00713297|"~     The objective of this prospective study is to build a real-time interactive platform where~     doctors and pharmacists may communicate and solve patients' drug-related problems (DRP)~     immediately and document accordingly. This study will also design a computerized physician~     order entry (CPOE) system utilizing default protocol for chemotherapy order entry.~   "
217428|NCT00713284|"~     The purpose of this study is to determine whether the combination of Myfortic and sirolimus~     is effective at preventing rejection while preserving kidney function in stable kidney~     transplant recipients.~   "
217429|NCT00713271|"~     The purpose of this study is to investigate the safety and tolerability of multiple once~     daily ascending doses of AZD3199 in healthy men~   "
217430|NCT00713258|"~     The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in~     reducing back pain intensity over a 24-week treatment period in postmenopausal women with an~     osteoporosis related vertebral fracture(s).~      Secondly the objectives are to investigate any differences in patient reported outcomes~     between the two treatment arms over a 24-week treatment period in postmenopausal women with~     an osteoporosis related vertebral fracture(s).~   "
217431|NCT00713245|"~     This study is to observe the progression of disease in late-onset Pompe disease~   "
217432|NCT00713232|"~     We will construct a Chinese Picture Naming test which include 60 items with various word~     frequency and familiarity and is arranged by their familiarity in daily life.~      Then we will collect the normative data for this test using normal subjects of various age~     and educational level.~   "
217433|NCT00713219|"~     This is a study for patients who have head and neck cancer that has recurred in the body area~     where they previously received radiation, and for whom surgery is not planned. A widely~     accepted treatment option in this situation is chemotherapy alone. Another approach that has~     been used in clinical trials is to treat patients with a repeat course of radiation. In these~     studies, some patients received chemotherapy at the same time as the radiation.~      In this clinical study, we wish to treat with radiation plus two drugs during the course of~     reirradiation, Taxotere® (docetaxel) and Erbitux® (cetuximab). Docetaxel and cetuximab both~     are chemotherapy drugs which are administered by vein. Both drugs help radiation kill cancer~     cells.~      The radiation will be administered using a strategy called intensity-modulated radiation~     therapy (IMRT), which focuses the radiation beam on the tumor.~      Docetaxel and cetuximab are both approved for the treatment of patients with head and neck~     cancer.~      However, the combination of radiation + docetaxel + cetuximab for patients with recurrent~     head and neck cancer is considered to be a topic for clinical research. The purpose of this~     study is to determine the good and bad effects of treatment with radiation + docetaxel +~     cetuximab.~   "
217473|NCT00712699|"~     This study will evaluate the safety and effectiveness of extended release mixed amphetamine~     salts in treating preschool children with attention deficit hyperactivity disorder.~   "
217474|NCT00712686|"~     The purpose of this study is to compare the efficacy and tolerability of aripiprazole to~     olanzapine over 26 weeks for the treatment of schizophrenia~   "
217436|NCT00713180|"~     The aim of the study is to find out why pterygium occurs and recurs in a rural African~     population. Participants will be interviewed on personal and lifestyle information, family~     history of pterygium, environmental exposure and history of previous eye inflammation. They~     will undergo eye examination and photography. Those with pterygium will be operated on to~     remove pterygium and followed up to detect any recurrence and complications of surgery. The~     excised pterygium will be examined pathologically and genetically; participant's blood will~     also be examined genetically. Data will be analyzed for statistically significant differences~     in findings between pterygium and pterygium free participants.~      The study hypothesis is that multiple factors are responsible for the occurrence and~     recurrence of pterygium in a rural african population.~   "
217437|NCT00713167|"~     Antioxidants are potent scavengers of free radicals and serve as inhibitors of neoplastic~     processes. A large number of synthetic and natural antioxidants are known to induce~     beneficial effects on human health and disease prevention. Cardioprotective ability of grape~     seed extract polyphenols (GSEP) was studied in animals and humans. It has been suggested that~     grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury~     of free radicals after ischemia. In another study, it is suggested that proanthocyanidins,~     the major polyphenols in red wine, might trap reactive oxygen species in aqueous series such~     as plasma and interstitial fluid of the arterial wall; thereby inhibiting oxidation of~     low-density lipoprotein (LDL) and showing an antiatherosclerotic activity. The only human~     model study designed to evaluate the effect of a standardized formulation of a GSEP~     (leucoselect-phytosome [LP]) on the susceptibility of LDL to oxidation in a group of heavy~     smokers, revealed that the antioxidant potential of GSEP may be effective in oxidative stress~     (smoking); however more investigational data are needed before wider use in clinical~     settings. Based on these observations, the investigators decided to evaluate the effect of~     GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.~   "
217438|NCT00713154|"~     The purpose of this study is to determine if MTS-01 is effective in preventing~     radiotherapy-induced hair loss in patients receiving whole brain radiotherapy~   "
217439|NCT00713141|"~     Primary Objective~        -  To investigate and clearly document the presence and extent of cognitive decline, if~          any, in women of Asian origin following standard-dose systematic adjuvant chemotherapy~          for the treatment of breast cancer~        -  Investigation and establishment of a relationship between degree of oxidative DNA and~          lipid damage as indicated by plasma and urinary biochemical markers.~      Secondary Objective~      • To validate the use of hydrogen peroxide and serum amyloid as biomarkers of damage~   "
217440|NCT00713128|"~     This is a study to determine how much nausea and or vomiting is caused by irinotecan-based~     chemotherapy in patients with colorectal cancer. Patients with colorectal cancer scheduled to~     receive their first cycle of an irinotecan-based chemotherapy regimen are eligible. Any~     chemotherapy agents administered in combination with irinotecan must have low-minimal~     potential to cause nausea and or vomiting. Examples of acceptable regimens would be~     irinotecan in combination with infusional fluorouracil and leucovorin (FOLFRI) with or~     without bevacizumab and irinotecan in combination with cetuximab. Patients who have received~     prior non-irinotecan-based chemotherapy are eligible providing they experienced no vomiting~     and no greater than mild nausea with their prior chemotherapy.~   "
217441|NCT00713115|"~     The study is a prospective radonmized comparison between needlescopic adrenalectomy and~     conventional laparoscopic adrenalectomy for benign adrenal tumors less than 5 cm. The~     operative success rate, operative time, intraoperative blood loss, intraoperative or~     postoperative complication, postoperative pain, postoperative hospital stay, convalescence,~     and wound cosmesis were compared.~   "
217442|NCT00713102|"~     The goal of this retrospective study is to describe emergency relevant illnesses occurring in~     airline passengers.~   "
217443|NCT00713089|"~     This study aims to document prospectively the incidence of allergies of eczema, asthma and~     allergic rhinitis in 2 diverse cohorts (Singaporean and Indonesian) with contrasting~     lifestyles and socioeconomic development. The profile of microbial colonization in terms of~     species variety, as well as their genetic diversity will be studied in Singapore and~     Indonesia cohorts and to correlate these with clinical allergy.~   "
217444|NCT00713076|"~     Measure wettability of hydrogel and silicone hydrogel contact lenses presoaked in a~     Multi-Purpose Solution.~   "
217445|NCT00713063|"~     The purpose of this study is to test the effect of a moderate-intensity aerobic exercise~     intervention for smokers interested in quitting smoking. We expect that this project will~     contribute much needed knowledge about the role of aerobic exercise in smoking cessation. If~     the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers~     may have a valuable adjunct to more traditional smoking cessation approaches.~   "
217446|NCT00713050|"~     Our overall goal is to advance the state of functional brain imaging in aphasia, and then to~     apply the method to an intensive, imitation-based treatment for non-fluent aphasia.~   "
217447|NCT00713037|"~     Before radiation treatment is given to treat chordomas, CT and MRI scans are used to create a~     three dimensional picture of the tumor using x-rays. The CT and MRI scans are used to~     determine the size and location of the area that will receive radiation treatment. The~     purpose of this research study is to see if combining the images from the FMISO-PET scan and~     the CT and MRI scans in radiation treatment planning changes the size and location of the~     area that will receive radiation treatment when compared to planning the radiation treatment~     with CT and MRI scans alone.~   "
217457|NCT00712907|"~     High arterial blood oxygen tension leads to vasoconstriction of retinal vessels, possibly~     related to an interaction between reactive oxygen species and endothelium-derived vasoactive~     factors. Vitamin C is a potent antioxidant capable of reversing endothelial dysfunction due~     to increased oxidant stress. Vitamin C appears to have vasodilatory properties, but the~     underlying mechanisms are not well understood.~      In the present study we hypothesized that hyperoxic vasoconstriction of retinal vessels could~     be diminished by vitamin C.~      Ocular blood flow will be determined by non-invasive methods, including laser Doppler~     velocimetry and the Zeiss retinal vessel analyser.~   "
217458|NCT00712894|"~     The purpose of this study is to evaluate the efficacy of three different vasodilators~     including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during~     direct percutaneous coronary intervention for acute myocardial infarction.~   "
217448|NCT00713024|"~     Patients with neuropathic pain exhibit hyperalgesia and allodynia. Although both peripheral~     and central determinants are recognized for the pathophysiological basis of neuropathic pain~     following peripheral injury, the modulating effect on pain processing in brain by peripheral~     mechanisms remains elusive. Here, we will systematically compare the sensory symptoms and~     brain activation to innocuous and noxious thermal stimulation applied to the distal leg, foot~     dorsum or forearm between patients with peripheral neuropathy and healthy controls.~     Functional magnetic resonance imaging will be used to define brain activation to somatic~     stimulation with noxious and innocuous stimuli. The blood-oxygenation-level-dependent signals~     will be correlated with visual analogue scale scores and sensory and affective components~     obtained from the Short-Form McGill Pain Questionnaire. Brain activation during thermal~     stimulation in patients with neuropathic pain will be clarified, and we will also analyze the~     potential relationships between the topography, quality and intensity of the different~     painful symptoms (i.e. spontaneous ongoing pain, paroxysmal pain, allodynia, hyperalgesia)~     and the magnitude and pattern of brain activation during thermal stimulation. This will add~     in our understanding in the pathophysiology of brain modulation in pain and provide~     clinically useful message toward the potential therapeutics in the management of neuropathic~     pain.~   "
217449|NCT00713011|"~     The study consists of a 12 week run-in period when all subjects are stabilized on a single~     dose of Avalide (300 mg/12.5 mg or 300mg/25mg dose) per day. After this 12 week run-in ends,~     subjects will be randomly assigned to start the addition of either Adalat XL or Tiazac XC for~     18 weeks of treatment. Subjects will have a 1 in 2 chance of receiving the study drug Adalat~     XL and a 1 in 2 chance of receiving the drug Tiazac XC. An end of treatment visit will be~     done 18 weeks after start of study drug. The expected duration of the study is 30 weeks. The~     purpose of this study is to compare the change in proteinuria, through a urine test, while~     taking study drug until high blood pressure (BP) is reduced to near normal levels in study~     subjects with diabetic nephropathy and hypertension.~   "
217450|NCT00712998|"~     The clinically widely used X-ray computed tomography examination has a low-grade radiation~     effect and recently has attracted much attention concerning the possible adverse effects of~     radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells~     mainly because it can interact with water (which makes up to 80% of cells) to generate~     reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we~     can reach, there is no report concerning the relation between X-ray computed tomography~     examination and the blood ROS concentration. Therefore, we wish to conduct this study to~     clarify if the routinely applied X-ray computed tomography examination may induce a higher~     concentration of ROS in the peripheral blood.~      Study subjects will be participants of health check program at our hospital. The only~     enrollment condition will be a scheduled X-ray computed tomography examination for either~     lung (20 cases) or heart (20 cases) of the study subject. Another 20 participants receiving~     health check program without X-ray computed tomography examination will be included as the~     control group. The formal consent will be delivered to the participants of health check~     program several days before their admission for health check and will be retrieved before the~     proceeding of health check.~      Measurements and comparison of ROS concentration will be performed in the sampled peripheral~     blood before and after the performance of X-ray computed tomography examination during a~     regular health check program. Totally 120 blood samples will be collected from included 60~     study subjects within 3 months. Reactive oxygen species（ROS）levels will be measured by a~     chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai,~     Japan).~   "
217451|NCT00712985|"~     The purpose of this research is to establish if a once a year dose of Zoledronic Acid is~     sufficient to suppress and maintain urine and serum bone density markers (NTx) and serum CTx~     within normal range at 12 months post-dosing in postmenopausal early breast cancer patients~     receiving additional treatment with non-steroidal aromatase inhibitors.~   "
217452|NCT00712972|"~     The goal of our study is to present important anatomic considerations which should be~     considered before knee injection is performed. Additionally, we have developed important~     procedural augments to the traditional para-patellar injection techniques in order to exceed~     the accuracy and safety previously reported for the infra-patellar approaches We have~     developed an injection technique which mechanically is similar to current techniques~     practiced and poses no additional risks or discomfort to the patient. The basis of our~     technique and its success is through recognition of anatomic factors and avoidance of~     possible iatrogenic injuries which exist when using other knee injection technique. The focus~     of our study is to validate the clinical accuracy we have been obtaining using our technique~     through fluoroscopically confirmed visualized confirmation of repeated intra-articular~     deposit. Additionally we want to document the range of needle length we require to properly~     access the knee joint in our population to substantiate the importance of needle length.~     Needle length is a critical factor in obese patients whom have larger infra-patellar fat~     pads.~      Our hypothesis is that when using a 6 inch 22 gage needle for intra-articular knee injections~     through the medial joint line approach, while utilizing the medial wall of the lateral~     femoral condyle as an intra-articular stop point for needle insertion, the accuracy of~     intra-articular deposit will exceed the values currently reported in the literature which is~     approximately 75% success rate.~      To prove this point we will be injecting 2 cc of radiocontrast dye into the joint space and~     than immediatly view the joint flouroscopicly after the knee has been brought through 10~     cycles of flexion and extension.~   "
217453|NCT00712959|"~     The purpose of this study is to collect additional immunogenicity and safety data on~     re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health~     need to establish broader population immunity against pertussis, as well as diphtheria and~     tetanus.~      Primary Objective:~        -  To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.~   "
217454|NCT00712946|"~     The goal of this study is to evaluate the possible preoperative predictive value of altered~     heart rate variability (HRV) and baroreflex sensitivity in different sleep stages for~     postoperative adverse cardiac events (i.e. arrhythmia or myocardial ischemia needing~     hospitalization or medication, myocardial ischemia assessed by enzyme release, myocardial~     infarction, sudden cardiac death, stroke) in arteriosclerosis obliterans patients.~   "
217455|NCT00712933|"~     This is a long-term continuation study to provide continuing treatment to subjects with SLE.~   "
217462|NCT00712842|"~     A variety of studies demonstrate that ocular blood flow is altered in diabetes and retinal~     perfusion abnormalities have been proposed to contribute to the pathogenesis of diabetic~     retinopathy.~      Various animal and human studies have demonstrated that retinal and optic nerve blood flow~     increase in response to diffuse luminance flicker. Based on studies with ERG, this effect has~     been attributed to augmented activity in the retinal ganglion cells and associated axons~     indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a~     variety of studies describe the effects of flickering light on retinal and optic nerve head~     blood flow, the knowledge about this coupling in the diabetic retina is sparse.~      In view of the fact that neural activity and blood flow are strongly coupled in the human~     retina, one could hypothesize that neurodegenerative changes in the retina could contribute~     to the vascular dysregulation and in turn lead to changes of ocular perfusion. The~     investigators set out to investigate whether the coupling of neural activity and blood flow~     is impaired in patients with early stage diabetic retinopathy compared to those in healthy~     volunteers.~   "
217463|NCT00712829|"~     This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly~     administered a single 10.0 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 (study drugs). The~     second (alternate) study drug will be administered approximately 14 days after the first. A~     final follow-up visit will occur approximately 2 weeks after the injection of the alternate~     study drug.~   "
217464|NCT00712816|"~     The purpose of the study is to evaluate the effectiveness of a device that delivers cold and~     intermittent compression as compared to ice and compressive wraps on patients who have~     undergone knee replacement.~   "
217465|NCT00712803|"~     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and~     subtropical regions of the world. The purpose of this study is to evaluate the safety of and~     immune response to a new dengue virus vaccine in healthy adults.~   "
217466|NCT00712790|"~     This Phase I/II trial will evaluate the safety and activity of chemo-radiotherapy comprising~     a regimen of Sorafenib chemotherapy plus SIR-Spheres yttrium-90 microspheres~     (chemo-radiotherapy, also known as chemo-SIRT), for first-line treatment of patients with~     primary hepatocellular carcinoma (HCC) in whom surgical resection is not feasible.~      This study is designed as a prelude to a planned future randomised comparative study that~     will compare the efficacy of Sorafenib plus SIR-Spheres versus Sorafenib alone, in this~     patient population.~   "
217467|NCT00712777|"~     Topical brimonidine is a recently introduced alpha 2 receptor agonist which is used in the~     therapy of intraocular pressure (IOP) reduction in patients with open angle glaucoma.~     Although adequate IOP reduction is achieved in many patients there is a considerable degree~     of variability in IOP reduction among subjects. The reason for this interindividual~     variability is not entirely clear. Obviously differences in pharmacokinetic properties due to~     variable penetration of the drug through the cornea may be responsible. Alternatively,~     polymorphisms of the alpha-2 receptor may account for the differences in IOP-lowering~     efficacy of topical brimonidine. This hypothesis is tested in the present study.~     Polymorphisms of the alpha-2 receptor have been described in a number of previous studies. In~     addition, polymorphisms in the alpha-2 receptor gene have been shown to be functionally~     important, particularly a polymorphism of the alpha-2B receptor, which has a high allele~     frequency in caucasians.~   "
217468|NCT00712764|"~     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in~     perfusion pressure. For a long time it had been assumed that the choroid is a strictly~     passive vascular bed, which shows no autoregulation. However, recently several groups have~     identified some autoregulatory capacity of the human choroid. In the brain and the retina the~     mechanism behind autoregulation is most likely linked to changes in transmural pressure. In~     this model arterioles change their vascular tone depending on the pressure inside the vessel~     and outside the vessel. In the choroid, several observations argue against a direct~     involvement of arterioles. However, the mechanism behind choroidal autoregulation remains~     unclear. Adenosine, an endogenous purine metabolic end product with a potent vasodilatory~     effect on multiple vascular beds, leads to an increase in retinal and choroidal vessel~     diameter. The present study aims to investigate whether adenosine plays a role in choroidal~     autoregulation during a decrease in ocular perfusion pressure, which will be achieved by an~     increase in intraocular pressure.~      Pressure/flow relationships will be investigated in the absence and presence of adenosine.~   "
217469|NCT00712751|"~     We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This~     study aims to learn:~        -  How the treatment affects emotional and social well-being.~        -  How a new sexual health educational program affects you.~      Cancer patients seek education for lots of reasons. It often helps them cope because they can~     express their feelings with a trained professional. This study is open to individuals who~     have been treated for rectal, colorectal or anal cancer. It involves a new type of sexual~     health counseling program. It will teach participants skills that they can use to improve~     their sex lives. These skills may also improve physical and emotional well-being. We will~     compare the new type of sexual health program with the standard care patients receive after~     treatment for rectal, colorectal or anal cancer.~   "
217470|NCT00712738|"~     This study will determine if nifedipine, a medication used to treat high blood pressure, can~     help treat iron overload, a condition in which the body contains too much iron. Iron overload~     can be caused by the body's inability to regulate iron or by medical treatments, such as~     multiple blood transfusions. Over time, it can cause problems with the liver, heart and~     glands. Treatments include reducing iron intake in the diet or removing the excess iron using~     medical therapies. Recently, nifedipine was found to cause iron loss in the urine of small~     animals. This study will see if the drug can increase the removal of iron into the urine in~     humans as well.~      People 18 years of age and older with iron overload may be eligible for this study to undergo~     the following procedures:~      Study Day 1~      Participants come to the NIH Clinical Center for a medical history, physical examination,~     blood and urine tests, electrocardiogram (EKG) and echocardiogram (heart ultrasound).~      Study Day 2~      Participants will collect three urine samples: one is collected over 4 hours, followed by a~     second over 4 hours. Both of these samples are collected at NIH in the outpatient day~     hospital. At home, a third urine sample will be collected over 16 hours. For 1 week before~     the collections, participants are asked not to drink tea or eat foods high in Vitamin C or~     iron. They are also asked not to take any iron chelating medications.~      Study Day 3~      Participants repeat the same urine collections as on day 2. They collect a 4-hour urine~     sample at the outpatient day hospital at NIH. They will then take a 20-mg tablet of~     nifedipine, and remain in the clinic 4 hours for blood pressure monitoring. A second urine~     sample during this time. They then return home to collect the final 16-hour sample, which~     they bring to the clinic the following day. Again, they are instructed to avoid a diet high~     in vitamin C, iron rich foods, tea, and to avoid taking any iron chelating medications.~   "
217471|NCT00712725|"~     The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of~     MK3207 in the treatment of acute migraine.~   "
217475|NCT00712673|"~     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in~     comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of~     treatment, followed by an extension.~      The primary objective is to assess the effects of lixisenatide as an add-on treatment to~     metformin in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.~      The secondary objectives are to assess the effect of lixisenatide, in comparison to placebo,~     when administered in the evening within 1 hour prior to the meal in terms of HbA1c reduction,~     percentage of patients reaching HbA1c less than (<) 7 percent (%), percentage of patients~     reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), plasma glucose,~     plasma insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test~     (only in morning injection arms), body weight, beta-cell function assessed by homeostasis~     model assessment (HOMA)-beta, fasting plasma insulin (FPI) and adiponectin; to evaluate~     safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development,~     beta-cell function 4 weeks after study drug discontinuation (only in patients from the~     morning injection arms in some selected centers).~   "
217476|NCT00712660|"~     Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will~     decrease the number of hospitalizations in patients with schizophrenia or schizoaffective~     disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction~     of the total number of hospitalizations due to relapse of psychosis at the end of the~     12-months follow-up period in the active ITAREPS group compared to the control~     (treatment-as-usual) group.~   "
217477|NCT00712647|"~     The Carotene and Retinol Efficacy Trial (CARET) was a randomized, double-blind,~     placebo-controlled trial of the cancer prevention efficacy and safety of a daily combination~     of 30 mg of beta-carotene and 25,000 IU of retinyl palmitate in 18,314 persons at high risk~     for lung cancer. CARET began in 1985, and the intervention was halted in January 1996, 21~     months ahead of schedule, with the twin conclusions for definitive evidence of no benefit and~     substantial evidence of a harmful effect of the intervention on both lung cancer incidence~     and total mortality. CARET continued to follow and collect endpoints on their participants~     through 2005. During the active intervention phase of CARET, serum, plasma, whole blood, and~     lung tissue specimens were collected on participants. These biospecimens make up the CARET~     Biorepository.~      The CARET Biorepository is a valuable resource for population-based studies of the major~     human cancers. During CARET's twenty years of follow-up (1985-2005), we have received reports~     of 1,445 participants with lung cancer, 901 with prostate cancer, 433 with breast cancer, 334~     with bladder cancer, 332 with colon cancer, and 1,429 with other cancers. CARET is one of the~     few trials that has prospectively collected serum, plasma, whole blood, blood spots (for~     DNA), and lung cancer tumor specimens, as well as smoking history and serial food frequency~     questionnaires (in some individuals for up to 12 years) in populations at high risk for lung~     cancer. This wealth of information in over 18,000 individuals makes the CARET Biorepository a~     special resource for cancer researchers.~   "
217478|NCT00712634|"~     RATIONALE: Vaccines may help the body build an effective immune response against~     cytomegalovirus.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of~     cytomegalovirus vaccine in healthy participants.~   "
217479|NCT00712621|"~     Rationale: Determining quality of life in breast cancer patient after completing chemotherapy~     or radiation therapy or surgical procedures or any combination therapy.~      Intervention includes supportive care in terms of psychological support and moral boosting~     efforts by counseling breast cancer survivors which may enhance the well-being and quality of~     life of women who are treated with chemotherapy or radiation therapy or surgical procedures~     or any given combination therapy.~      PURPOSE: Randomized clinical trial study to compare the effectiveness of support system and~     counseling of breast cancer survivors on the well-being of women, who have completed various~     modes of treatment of breast cancer with the subjects who have no support system.~      Study Type: Quality of life and survival~      Study Design: Two arm randomized controlled clinical trial to study quality of life and~     survival of breast cancer patients after completion of chemotherapy or radiation therapy or~     surgery or any combination therapy. The stages from I to IV (metastases to other sites of the~     body) are included.~   "
217480|NCT00712608|"~     A study to evaluate the growth and development of term infants fed either a marketed cow's~     milk formula, or an experimental cow's milk formula with prebiotics + a different calcium~     source + a different level of fatty acids and fat, or an experimental cow's milk formula with~     prebiotic + a different calcium source + a different level of fatty acids and fat~   "
217481|NCT00712595|"~     The objectives of this study are to estimate the efficacy and safety of the daily~     administration of mifepristone 5 mg versus 10 mg for three months for the treatment of~     uterine fibroids.~      The hypothesis of the study is that both mifepristone doses reduce the volume of the myoma in~     about 40% after 3 months of treatment.~   "
217482|NCT00712582|"~     About 60% of patients with DLBCL can be cured with a chemotherapy program. It is called~     RCHOP-21 (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). It is given~     once every 3 weeks, for 18 weeks. Each three weeks is a cycle. Some factors predict that you~     may not be cured with R-CHOP-21. The most common ones are:~        -  Stage - how much DLBCL, PMBL, or FL3B you have~        -  LDH - a blood chemistry marker; and~        -  Whether you can do your normal daily activities. (performance status) We think that the~          best way to cure more patients with poor risk factors is to add new treatment to R-CHOP.~          You will get different chemotherapy after 4 cycles. This type of treatment is called~          risk-adapted therapy.~   "
217483|NCT00712569|"~     The purpose of this study is to learn about how patients who have looked up cancer-related~     information on the internet talk with their doctors. We are interested in these conversations~     even if the patients do not think they will talk about the information with their doctor~     during their visit. We will audio record doctor-patient visits and listen to these recordings~     to learn about how patients who have looked up cancer-related internet information talk to~     their doctors and how their doctors talk to them. We will also give patients questionnaires~     before and after their appointments to learn about what they think about communicating with~     their doctors.~   "
217594|NCT00711113|"~     The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture~     Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading~     protocol. Primary objectives are implant stability, marginal bone adaptation and survival~     rate.~   "
217484|NCT00712556|"~     RATIONALE: Diagnostic procedures, such as fluorine 18-fludeoxyglucose positron emission~     tomography (PET) scans, may help doctors predict a patient's response to treatment and help~     plan the best treatment.~      PURPOSE: This phase I trial is studying fluorine 18-fludeoxyglucose PET scan to see how well~     it predicts outcomes in patients who have undergone high-dose chemotherapy and autologous~     stem cell transplant for non-Hodgkin lymphoma.~   "
217485|NCT00712543|"~     This study will evaluate whether patients have an overall preference for Kristalose® or~     liquid lactulose based on taste, consistency, and portability.~   "
217486|NCT00712530|"~     -  DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered~          topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir~          migrate to lymph nodes and express HIV-like particles that induce immune responses to~          kill HIV-infected cells.~        -  Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction~          of HIV-specific precursor/memory T cell responses.~        -  GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the~          safety and immunogenicity of three dosing regimens of topical DermaVir immunization for~          the treatment of HIV-infected individuals on fully suppressive highly active~          antiretroviral therapy (HAART).~   "
217487|NCT00712517|"~     The study will test the hypothesis that patients anesthetized with propofol suffer less~     postoperative pain than those anesthetized with sevoflurane.~   "
217488|NCT00712504|"~     This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib~     malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be~     tested in patients with advanced solid tumors, including non small cell lung cancer.~   "
217489|NCT00712491|"~     The purpose of this study is to determine the safety and efficacy of an ocular sirolimus~     (rapamycin) formulation via different injection routes in patients with treatment-naive~     sub-foveal choroidal neovascularization secondary to age-related macular degeneration.~   "
217490|NCT00712478|"~     This study is conducted in Europe. The aim of this observational study is to determine~     diabetes control improvement, during the third month of follow-up after insulin~     intensification to at least 3 daily insulin injections, in assessing the proportion of~     uncontrolled fasting and postprandial glycaemia values recorded on a diary.~   "
217491|NCT00712465|"~     The primary purpose of this study is to learn more about how digoxin is handled by the body,~     i.e. absorption, distribution, metabolism and excretion, when administered alone and in~     combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled~     by the body when administered alone and in combination with digoxin and to learn more about~     how AZD1305 and digoxin administered alone and in combination affect the body.~   "
217492|NCT00712452|"~     The objective is to evaluate the influence of chemotherapy, either for auto-immune disease,~     either for carcinologic disease, on clinical and biological markers of ovarian reserve, for~     young patients, with normal reproductive functions.~   "
217493|NCT00712439|"~     The purpose of this study is to determine whether a new Gabapentin tablet, is safe and~     effective for the treatment of painful diabetic peripheral neuropathy.~   "
217494|NCT00712426|"~     Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those~     affected and their families. There are no treatments that slow the progression of HD, only~     mildly effective symptomatic therapies are available.Creatine monohydrate is considered a~     nutritional supplement. The purpose of CREST-E is to test whether high-dose creatine can slow~     the progressive functional decline that occurs in persons 18 years or older with early~     clinical features of HD. The long-term safety, tolerability and effectiveness of up to 40~     grams daily creatine compared to placebo is studied. A variety of biological processes are~     assessed for markers of disease activity or progression and creatine effects. Up to 50 active~     research centers globally will enroll 650 subjects.~   "
217495|NCT00712413|"~     The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera~     approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given~     twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will~     receive Pylera treatment and omeprazole twice daily.~   "
217496|NCT00712400|"~     Latanoprost is a synthetic prodrug of 17-phenyl-substituted prostaglandin F2α analog. Used at~     a dose of one drop per day, it has been reported to produce a 30 to 35% reduction in~     intraocular pressure. Its mechanism of activation involves augmentation of the eye's natural~     uveoscleral outflow capacity .~      There is evidence that ocular blood flow plays a role in the clinical course of glaucoma.~     Glaucoma medication that lowers IOP simultaneously increases ocular blood perfusion pressure,~     which in turn may increase ocular blood flow.~      This could well contribute to the partially contradicting results concerning ocular~     hemodynamic effects of latanoprost. In vitro studies indicate that latanoprost has no effect~     on ocular vascular tone in therapeutical doses. By contrast, it has been reported in several~     studies that latanoprost 0.005% increases pulsatile ocular blood flow in patients with~     primary open angle glaucoma and normal tension glaucoma. This increase in pulsatile ocular~     blood flow mainly reflects an increase in the choroidal circulation.~      Little is known about the potential effect of latanoprost on choroidal blood flow regulation~     in humans. The present study therefore tries to elucidate whether treatment with latanoprost~     may alter choroidal blood flow regulation during artificial changes in ocular perfusion~     pressure. In addition, the present study aims to clarify whether the change in choroidal~     blood flow after latanoprost administration are due to direct vasoactive effects or due to~     the increase in ocular perfusion pressure. The second alternative may have important~     implications on our understanding of glaucoma treatment, because reduction of IOP may then~     per se result in normalization of ocular blood flow regulation.~   "
217497|NCT00712387|"~     The hypothesis of this trial is to demonstrate that training junior surgeons on a virtual~     reality (VR) simulator in addition to didactic teaching will improve their intraoperative~     performance compared to those trainees who receive the traditional teaching paradigm (i.e,~     operating under the guidance and instruction of a consultant general surgeon).~      We anticipate that the VR trained group will make less critical intraoperative errors and~     will perform faster than their traditionally trained colleagues.~      Other study questions include:~        1. Does objective assessment of fundamental abilities (FA) such as visuo-spatial ability~          predict intra-operative performance?~        2. Do FA predict rate of learning to reach proficiency?~   "
217498|NCT00712374|"~     In areas of seasonal malaria transmission the burden of severe disease and mortality due to~     malaria is mainly among children under 5 years of age. Intermittent preventive treatment~     (IPT) with antimalarial drugs given to all children once a month during the transmission~     season is a promising new strategy for malaria prevention. Studies in Senegal, Ghana, Mali~     and The Gambia have shown this approach can be highly effective. In Senegal, seasonal IPT~     with sulfadoxine-pyrimethamine (SP) and one dose of artesunate resulted in a 90% reduction in~     incidence of clinical malaria in a recent trial in Senegal (Cisse et al., Lancet 2006). The~     purpose of the present project is to determine the public health impact and cost~     effectiveness of this intervention when it is delivered through the routine health service to~     communities in rural areas in Senegal. Demographic surveillance will be set up in the rural~     population of three districts (Mbour, Bambey and Fatick) which comprises approximately~     540,000 people, including 100,000 children under 5 yrs, and is served by 54 health posts, as~     an expansion of the area covered by the existing DSS of Niakhar. Information about births,~     deaths and migrations, household characteristics such as socioeconomic status, and~     vaccination status of children and their use of bednets, will be recorded in 6-monthly rounds~     of all households. In selected areas, deaths among children under 10 years will be~     investigated using verbal autopsies. Over four years from September 2008 - November 2011,~     seasonal IPT (three monthly administrations of SP (sulfalene-pyrimethamine) plus amodiaquine~     during the transmission season each year to children 3-59 months of age) will be introduced~     gradually, in a step-wedge design, by 9 health posts in 2008, by an additional 18 posts in~     2009, and another 18 in 2010 and 9 in 2011. At the end of each transmission season, a~     cross-sectional survey of 2400 children under 5 yrs of age, in which finger prick blood~     samples will be taken, will be used to estimate the prevalence of molecular markers of drug~     resistance to Plasmodium falciparum, the prevalence of anaemia and the nutritional status of~     children. Malaria incidence will be monitored by passive surveillance through health posts,~     health centres, and hospitals. Cost effectiveness will be assessed. Due to changes in the~     epidemiology of malaria in the study area, the upper age limit for inclusion was increased~     from 5 to 10 years old from September 2009.~   "
217499|NCT00712361|"~     1. Aim:~           SoftTouch is a non-invasive device intending for use in the temporarily quantitative~          measurement of peripheral blood biomarkers. The aim of the clinical trial is to study~          the accuracy of the SoftTouch device compared with registered (FDA-approved) invasive~          and non-invasive devices.~        2. Hypothesis:~      Human physiological biomarkers may be measured from the color distribution of the internal or~     external (skin) tissue. The technology of the SoftTouch finger-mounted device is based on the~     color distribution of the peripheral blood tissue, which enables the measurement of certain~     biomarkers and vital signs under consideration.~   "
217500|NCT00712348|"~     This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase~     alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase~     (Cerezyme®) enzyme replacement therapy.~   "
217501|NCT00712335|"~     The purpose of this study is:~        1. To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices~          between smokers and non-smokers.~        2. To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.~   "
217502|NCT00712322|"~     This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral~     suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. The results~     will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.~   "
217503|NCT00712309|"~     1. Does primary stenting have a lower 12-month restenosis rate than PTA alone in the~          treatment of atherosclerotic lesions of the popliteal artery?~             -  Alternative hypothesis: Primary stenting with the Edwards LifeStent is associated~               with a lower restenosis rate than PTA alone in patients with atherosclerotic~               lesions of the popliteal artery at 12 months~             -  Null hypothesis: Primary stenting with the Edwards LifeStent is not associated~               with a lower 12-month restenosis rate than PTA alone in patients with~               atherosclerotic lesions of the popliteal artery~        2. Does comparison of the two intervention groups (PTA alone, stenting) disclose~          differences in terms of the secondary endpoints?~        3. How do the intervention methods compare in terms of safety/incidence of adverse effects?~        4. What are the long-term clinical implications of the two treatment methods?~   "
217504|NCT00712296|"~     The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine~     intervention (ASHMI) in adult asthmatics~   "
217505|NCT00712283|"~     Determination of the ability to drive and operate machines after single and multiple oral~     dose of Neramexane as compared to placebo~   "
217506|NCT00712270|"~     This study is being conducted to find a way to predict how individual schizophrenic patients~     will respond if they are treated with different types of antipsychotic drugs. This could help~     doctors prescribe the medication that will work best for each individual.~   "
217507|NCT00712257|"~     A Multicenter study to evaluation the safety and performance of Spectranetics Laser with~     Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis~   "
217508|NCT00712244|"~     A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices~     (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior~     chamber space maintenance during non-eventful cataract surgery.~   "
217509|NCT00712231|"~     There have been numerous studies comparing various ACD measurements in phakic eyes,while~     researches comparing ACD in pseudophakic eyes are less extensive. With the recent popularity~     of presbyopia correction, measuring the ACD will facilitate differentiating pseudophakic~     accommodation from pseudoaccommodation. It is thus mandatory to verify the accuracy of ACD~     measurement of these devices since the innovation of various IOLs in the recent decade makes~     this task more complicated. In this study, we will assess the limitations of using Pentacam~     for ACD measurement in pseudophakic eyes and compare Pentacam measurement with IOLMaster and~     A-scan measurements.~   "
217510|NCT00712218|"~     To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with~     advanced ovarian cancer and intra-abdominal complete debulking.~      Secondary: progression-free survival, complications and quality of life; Exploratory: Role of~     number of resected lymph nodes for primary and secondary objectives~   "
217511|NCT00712205|"~     The investigators want to test the hypothesis, that vitamin D3 improves pulmonary function~     and quality of life in patients with asthma relatively resistant to glucocorticoids.~   "
217532|NCT00711932|"~     The goal of this study is to determine the apoptosis-inducing efficacy of TRA-8 in patient~     ovarian cancer tissues using a tissue slice technology. In addition, we want to evaluate the~     expression of apoptosis regulatory proteins using multiplex proteomic technology and its~     correlation with TRA-8-induced cytotoxicity in patient ovarian cancer tissues.~   "
217533|NCT00711919|"~     This study is aimed to analyze the effects of aggressive and conventional lipid lowering~     therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with~     hyperlipidemia and abnormal thickening of IMT.~   "
217512|NCT00712192|"~     Although the long saphenous vein remains the most commonly used conduit in coronary~     revascularization, traditional open vein harvest may lead to significantly impaired wound~     healing and post-operative pain. To this end, endoscopic saphenous vein harvesting techniques~     have been shown to reduce post-operative morbidity. Studies have shown that endothelial~     integrity and luminal nitric oxide synthase (NOS) are better preserved with novel no-touch~     techniques; however, the effect and the associated mechanism of endoscopic vein harvest on~     endothelial integrity and function remain unknown. Therefore, in the present proposal, we~     will collect the saphenous vein segements immediately after harvesting, reperfusion, and~     grafting, and then use enzyme-linked immunosorbant assay (ELISA), immunohistochemical~     staining (IHC), and real-time polymerase chain reaction (RT-PCR) to detect the expression and~     distribution of endothelial NOS (eNOS), endothelin-1 (ET-1), vascular cell adhesion~     molecule-1 (VCAM-1), intracellular adhesion molecule-1 (ICAM-1), and platelet endothelial~     cell adhesion molecule-1(PECAM-1) at protein and RNA levels in the endothelium of saphenous~     veins. The major aim of this study is to elucidate the effect and mechanism of endoscopic~     saphenous vein harvesting on endothelial properties as compare to conventional open vein~     harvest technique.~   "
217513|NCT00712179|"~     This is a research study to understand how people who have experienced a stroke walk in order~     to develop better and more effective types of therapy. Data collected from people who have~     experienced a stroke and healthy individuals will be used to compare a neurologically healthy~     person to someone, which has sustained an injury.~   "
217514|NCT00712166|"~     The purpose of this study was to evaluate the safety and efficacy of a 28-day course of~     aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung~     disease (forced expiratory volume in 1 second [FEV1] >75% predicted, and Pseudomonas~     aeruginosa (PA) infection.~   "
217515|NCT00712153|"~     Coronary artery disease is a major cause of morbidity and mortality across the world and~     coronary artery bypass surgery (CABG) is the most common surgical procedure for treatment.~     Patients with recurrent ischemic symptoms after CABG are most likely to have occluded or~     significantly stenosis in grafts or native coronary arteries. Therefore, there is a need to~     evaluate the patency of these vessel conduits after CABG. Until now, selective coronary~     angiography is the traditional gold standard for the assessment of both native coronary~     arteries and bypass grafts. But it is an invasive procedure that requires x-ray exposure,~     hospitalization, and includes a risk for complication. However, there is an alternative~     noninvasive method, multislice computed tomography (MSCT), with high specificity and~     excellent sensitivity for the detection of the coronary artery disease. It is even cheaper~     and takes shorter time to perform. Accordingly, the purpose of this study is to use MSCT to~     evaluate the patency and the quality of all grafts and native coronary arteries after CABG~     for more than two years. In addition, we will elucidate the relationship of these data and~     CABG procedures to review our experience.~   "
217516|NCT00712140|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. It is not yet known which regimen~     of trastuzumab is more effective in treating early breast cancer.~      PURPOSE: This randomized phase III trial is comparing two trastuzumab regimens to see how~     well they work in treating women with HER2-positive early breast cancer.~   "
217517|NCT00712127|"~     The purpose of this project is to establish a Center of Excellence in Research on Obesity~     that will focus on severe obesity. The prevalence of severe obesity (i.e., Class 2 and 3~     obesity; body mass index > 35 kg/m2 and 40 kg/m2) is increasing more rapidly than is~     overweight and Class 1 obesity. Treatment guidelines for severe obesity are uncertain.~      Three novel hypotheses regarding the pathogenesis of severe obesity will be tested: a) using~     non-invasive methods to measure energy expenditure; b) conducting an annotated lipomic search~     for bio-markers of impaired fat oxidation; and c) examining the role of obesity-induced~     inflammation as a cause for leptin resistance. Responses will also be measured following~     intervention with diet and activity.~   "
217518|NCT00712114|"~     The purpose of this pilot, exploratory study is to evaluate the safety, tolerance,~     pharmacokinetics and potential anti-inflammatory activity of an investigational agent,~     HE3286, when administered orally for 29 days to patients with rheumatoid arthritis that are~     taking a stable dose of methotrexate.~   "
217519|NCT00712101|"~     The purpose of this study is to examine whether intracoronary abciximab bolus application~     with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary~     intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus~     application with respect to 90-day mortality, reinfarction and new congestive heart failure.~   "
217520|NCT00712088|"~     This project will test the efficacy of a behavioral intervention to reduce sexual risk for~     HIV infection among African American Men who Have Sex with Men (MSM).~   "
217521|NCT00712075|"~     Aging and psychosis are major priority areas for VA. This project is a continuation of a~     Merit Review Program, in which we developed, manualized and conducted randomized controlled~     trials of a novel psychosocial rehabilitation intervention for older people with~     schizophrenia, called cognitive-behavioral social skills training (CBSST). We found that~     CBSST improved community functioning in these patients. CBSST, however, is an intensive~     program that would burden VA mental health clinics with demands for additional staff and~     financial resources and burdens older veterans with travel and time demands. To reduce these~     burdens and barriers to implementation of CBSST, we are developing a computer-assisted CBSST~     intervention that takes advantage of available handheld computer technology. Therapist~     contact is cut 50% and replaced by handheld computer-assisted CBSST intervention tools. The~     project will examine whether computer-assisted CBSST is as effective as the full CBSST~     program, while improving client satisfaction and reducing burden and cost.~   "
217522|NCT00712062|"~     The purpose of this study is to determine if pemetrexed is effective in the treatment of~     primary central nervous system lymphoma (PCNSL) that has either worsened during treatment or~     has returned after completing treatment.~   "
217549|NCT00711711|"~     The purpose of this study is to evaluate the efficiency of manual lymphatic drainage to~     decrease the swelling of the knee after total knee replacement surgery~   "
220802|NCT00668642|"~     The purpose of this study is to determine if the drug dutasteride increases expression of~     genes that slow the growth of prostate cancer during treatment with intermittent androgen~     ablation therapy (hormone therapy).~   "
217523|NCT00712049|"~     Dyslipidaemia is characterized by low plasma levels of high-density lipoprotein cholesterol~     (HDL-c), elevated triglycerides and an increase in low density lipoprotein (LDL-c) particles,~     and has been unequivocally established as a most important cardiovascular risk factor. While~     statins are effective in reducing plasma levels of LDL-c, these drugs have only modest~     effects on raising HDL-c (typically by less than 10%), even with aggressive statin therapy.~     However, increasing evidence suggests that low HDL-c might be at least as relevant as high~     LDL-c in promoting the development and progression of atherosclerosis. The beneficial effect~     of raising HDL-c on clinical outcome has already been demonstrated by several studies.~      Nicotinic acid is the most potent agent available for raising plasma levels of HDL-c by up to~     29% at clinically recommended doses, and substantially lowers triglycerides and LDL-c.~     Furthermore, nicotinic acid is also the most potent lipid lowering agent available that~     reduces Lp(a), an independent marker of cardiovascular risk. In a recent study patients with~     coronary artery disease had a 21% increase in HDL-c and a 13% decrease in triglycerides, and~     these beneficial effects on lipid status may have contributed to a stabilization or~     regression of carotid intima-media-thickness (IMT).The impact in patients with advanced~     atherosclerosis like peripheral artery disease (PAD) in unknown.~      The investigators hypothesized that nicotinic acid in addition to statin therapy may inhibit~     progression of peripheral arterial atherosclerosis. Therefore, the aim of the present~     randomized controlled trial is to investigate the effects of nicotinic acid (daily dose~     starting with 500 mg, up to 2000mg) in addition to simvastatin (40 mg daily) versus~     simvastatin (40mg daily) monotherapy in patients with low serum HDL-C levels and PAD with~     respect to changes of carotid and femoral IMT, changes of patients´ lipid status and~     occurrence of major adverse cardiovascular events (MACE).~   "
217524|NCT00712036|"~     The purpose of the study is to determine whether one of three levels of counseling intensity~     will be associated with better treatment outcomes when combined with methadone maintenance~     treatment for heroin-addicted adults drawn from a methadone treatment program waiting list.~   "
217525|NCT00712023|"~     The purpose of this study is to determine whether a custom-made forced-air warming mattress~     can prevent heat loss in patients undergoing vascular surgery better than a circulating-water~     mattress~   "
217526|NCT00712010|"~     The purpose of the clinical study is to investigate the effect of the protein quality of~     high-protein meal replacements on the management of post-prandial blood glucose in healthy~     men.~   "
217527|NCT00711997|"~     This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and~     preliminary efficacy of DTA-H19 administered intratumorally in patients with unresectable,~     locally advanced pancreatic cancer.~      Primary Objective: The primary objective is to determine the maximum tolerated dose (MTD) of~     intratumoral DTA-H19 and identify any dose limiting toxicities (DLTs).~      Secondary objectives include determining the adverse events (AEs) profile, effects on~     clinical laboratory analytes, vital signs, PK, tumor response, and possible tumor~     resectability after 4 intratumoral administrations of DTA-H19.~   "
217528|NCT00711984|"~     Renal artery stenosis (RAS) usually refers to a disease of the large extra-renal arterial~     vessels and most frequently is caused by atherosclerotic obstructions. The prevalence of~     atherosclerotic RAS increases with age, male gender, traditional cardiovascular risk factors~     (hypertension, diabetes, smoking, hyperlipidemia) and atherosclerotic comorbidities like~     coronary artery or peripheral artery disease (PAD). A prevalence up to 40% has been reported~     in patients with PAD. Undoubtedly, atherosclerotic RAS is a progressive disease, as more than~     half of the patients exhibit an increasing degree of stenosis within five years after~     diagnosis, and one out of five patients with a critical stenosis (>60%) suffers renal atrophy~     and renal failure during this period. RAS may be treated conservatively by so called best~     medical treatment, surgically, or by endovascular interventions using balloon angioplasty and~     stenting.~      The purpose of the investigators study is to determine the incidence and the predictors of~     RAS in patients with PAD, and to compare the effect of renal artery stenting versus best~     medical treatment in patients with hypertension and ostial renal artery stenosis in a~     randomized controlled trial.~   "
217529|NCT00711971|"~     This study is designed to test whether an alternative medicine treatment, fish oil, will~     prevent depressive symptoms in pregnant and postpartum women who have been found to be at~     risk for depression. Epidemiologists have observed that people who live in countries where~     people on average eat a diet high in fish have a lower risk of depression than people who~     live in populations that eat less fish. Postpartum depression is also less common in these~     countries. The omega-3 fatty acids found in fish oil are thought to be responsible for this~     beneficial effect of eating fish. The two major omega-3 fatty acids found in fish are~     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an essential building~     block of the brain and nerve tissue. EPA may act to optimize the electrical signals between~     nerve cells and brain cells and may help the immune system to function well.~      Some researchers have treated people who are already suffering from depression with fish oil.~     Some of these studies have shown a benefit for the fish oil treatment and others have not.~     These studies have tested EPA and DHA alone and in various combinations. Currently, it is not~     known whether EPA or DHA is more effective in preventing and treating depression. Some of the~     researchers involved in this study have learned how to identify mothers who are most at risk~     for developing depression during and after pregnancy. This study is designed to learn whether~     EPA-rich and DHA-rich fish oil supplements will prevent depressive symptoms in women who are~     at risk to develop depression.~   "
217530|NCT00711958|"~     This is a randomized, double-blind, multicenter clinical phase III study involving about 105~     cancer patients aged >18 years who are receiving palliative chemotherapy and who are~     suffering from chemotherapy associated anemia. A standard treatment group (ERYPO®) will be~     included to provide a reference reflecting current standard medical practice.~   "
217531|NCT00711945|"~     Pediatric Crohn's Disease is a life long disease , presenting early in life.As such , it is~     imperative to be able to evaluate the risk for more severe disease and poorer outcomes when~     making the decision which therapies to offer our patients. These decisions should be based~     according to longer-term disease outcomes, such as whether they prevent disease relapse or~     prolong remission [10-12]. However, for the most part, previous studies were not designed to~     yield predictive parameters that could allow a clinician to differentiate which patients are~     at a higher risk for relapse, or more likely to to have serious attacks or complications of~     the disease or therapy. The ability to predict these risks would impact dramatically the way~     CD patients are treated, allowing the clinician to tailor therapy, both type and intensity,~     to each patient's individual risk for relapse and outcomes.In the present first phase of the~     study , we will attempt to identify factors that predict relapse of the disease, focusing on~     the use of calprotectin at onset and after clinical remission, and on the use of anti-glycan~     antibodies, as well as disease severity, site and phenotype.~   "
217574|NCT00711386|"~     To determine safety, tolerability and Pharmacokinetics of GSK706769~   "
217534|NCT00711906|"~     Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women~     and children are the most vulnerable population. Malaria in pregnancy increases the risks of~     abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and~     infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive~     Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia~     are recommended.~      HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also~     of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine~     sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety~     in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a~     documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative: many~     studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV~     infected persons, and CTX prophylaxis significantly improves birth outcomes in~     immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness~     for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we~     aim to establish the safety and efficacy of daily CTX in preventing malaria infection during~     pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This~     information is urgently needed to assist to issue guidelines on IPT in pregnancy.~   "
217535|NCT00711893|"~     The purpose of this evaluation is to assess the acceptance level of specific programming~     recommendations based on the patient's clinical needs and primary indications when using the~     feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application~     for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming~     chosen by physicians.~   "
217536|NCT00711880|"~     The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in~     relieving peripheral neuropathic pain associated with allodynia.~   "
217537|NCT00711867|"~     The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post~     anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System~     under general anesthesia for total knee arthroplasty will be equivalent to that of patients~     warmed with the Arizant Bair Hugger System.~   "
217538|NCT00711854|"~     MRSA infections often require systemic antibiotic therapy and represent an important~     healthcare burden. Currently available treatment options are either only available in~     parenteral form (vancomycin) or expensive (linezolid). Thus, there is an urgent, unmet need~     to better investigate in-expensive but highly active alternatives to currently recommended~     standard treatment options. The purpose of the proposed study is to test the hypothesis that~     a combination of TMP-SMX and rifampicin is not inferior to linezolid for treatment of MRSA~     infections.~   "
217539|NCT00711841|"~     Corticotherapy accelerates maternal postpartum recovery in women with class I HELLP syndrome.~     The benefit of faster and better recovery would be observed in fewer complications, less~     utilization of blood products and shorter hospital stay.~   "
217540|NCT00711828|"~     This phase II trial is studying how well giving rituximab and cyclophosphamide together with~     bortezomib and dexamethasone (R-CyBor-D) works in treating patients with relapsed or~     refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell~     lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.~   "
217541|NCT00711815|"~     This is a research study looking at gene characteristics in blood and Pap smear samples in~     hopes of identifying markers that will predict if the HPV infection is present or not.~   "
217542|NCT00711802|"~     This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess~     the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to~     17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by~     Gram-positive pathogens.~   "
217543|NCT00711789|"~     The purpose of this study is to determine the effect of a systemic infusion of angiotensin II~     on haemodynamics and urine output in critically ill patients with severe sepsis/septic shock~     and acute renal failure.~      It will also help determine the feasibility of conducting a definitive and adequately powered~     randomised controlled trial of angiotensin II in such patients that would assess mortality~     and need for renal replacement therapy as endpoints.~   "
217544|NCT00711776|"~     This study is designed to show bioequivalence between Current and New formulation of~     Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects~   "
217545|NCT00711763|"~     The aim of our work is to study the effect of total parenteral nutrition (TPN) cycling in~     preterm infants on hypercalcuria (excessive calcium excretion in urine). TPN cycling refers~     to administering the TPN over a portion of the day rather than the whole day. Our hypothesis~     is that cyclic TPN includes more hypercalcuria in preterm infants as compared to continuous~     TPN.~      Objectives:~      Measure Urinary Calcium(Ca) during the periods of continuous and cyclic TPN.~      Compare the amount of Ca losses in the urine continuous vs. cyclic TPN~   "
217546|NCT00711750|"~     Objectives: Examine the acute utility of immediate maintained cannulations of a newly~     implanted prosthetic arteriovenous access. Background: Recurrent failure of central~     catheterization is not uncommon. An alternative access is necessary for acute hemodialysis~     after the exhaustion of central veins. Methods: We constructed the access by cannulating two~     dialysis needle-catheters and securing them on the skin after the implantation of the graft.~     The access was used immediately and maintained for one week and thereafter used as a~     long-term access.~   "
217547|NCT00711737|"~     The purpose of this study is to explore the changes in metabolic parameters in patients~     treated with escitalopram for six months for major depression, generalized anxiety disorder~     or panic disorder, with or without agoraphobia.~   "
217548|NCT00711724|"~     The primary objective is to establish the concurrent validity of the clinician administered~     Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS) and the patient administered~     Attention Deficit Hyperactivity Disorder Self Report Scale (ASRS) v1.1 Symptom Checklist.~   "
217550|NCT00711698|"~     This research is being done to find out the best way to give narcotics for pain relief in~     adults with sickle cell disease and painful crisis. This study is a comparison of two ways of~     giving narcotics. The first way is what occurs now in the Emergency Acute Care Unit (EACU)~     where patients are given a single intravenous (iv) dose of a narcotic which is repeated by~     the nurse as needed to control the pain. The second way is to provide a single iv dose of~     narcotic and then allow the patient to push a button and receive one or more additional doses~     of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more~     effective way of controlling pain.~   "
217551|NCT00711685|"~     Sternal or mediastinal infections after heart operation occurs infrequently but carries a~     high cost in money, morbidity, and mortality. At our hospital, Staphylococcus species cause~     most of these infections and is uniformly sensitive to vancomycin. However, the relative low~     concentration of vancomycin in sternal bone was noted given intravenously. Topical vancomycin~     was therefore considered to apply on the cut edege of sternal bone before closure in patients~     receiving coronary artery bypass graft to evaluate the effect on reducing the infection rate~     of staphylococcus related mediastinitis (6). In addition, we try to observe that prophylactic~     use of topical vancomycin will increase the risk for acquiring resistant pathogen such as~     VISA (vancomycin-intermediate S. aureus), VRSA (Vancomycin-resistant S. aureus), VRE~     (vancomycin-resistant enterococcus)~   "
217552|NCT00711672|"~     The purpose of this study is to determine if the degree of agreement between patients and~     their physicians regarding the story of the illness correlates with improved patient~     symptom control and quality of life. Another goal of the study is to examine the actual~     language used by patients and physicians in a specific clinical situation.~   "
217553|NCT00711659|"~     The study proposes that a workshop-based educational experience which utilizes a standardized~     preceptor training session, a standard skills assessment checklist, and videotaped feedback~     will improve student comfort and confidence in performing the pediatric physical examination~     and will provide information to improve the curriculum offerings.~   "
217554|NCT00711646|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in~     subjects diagnosed with MS and spasticity.~   "
217555|NCT00711633|"~     The intestinal flora is a complex ecosystem which is known to play various important~     functions in the gut. Recent data have reported a delay in intestinal colonization in~     preterm. Modulating the intestinal flora through dietary supplementation with probiotics or~     prebiotics has been shown to improve digestive and general outcomes in full-term infants.The~     aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and~     the mucosal inflammatory responses to a fermented milk in preterm infants.~   "
217556|NCT00711620|"~     The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe~     sepsis.~   "
217557|NCT00711607|"~     The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and~     E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2~   "
217558|NCT00711594|"~     The objective of the Phase I step is to estimate the MTD at a dose level up to 50 mg/day~     (i.e., overseas recommended Phase II dose) in patients with advanced NSCLC and to determine~     the recommended dose for the Phase II step.~      The objective of the Phase II step is to estimate the efficacy of BIBW 2992 monotherapy in~     patients with first generation EGFR-TKI-resistant advanced NSCLC at the recommended dose~     determined in the Phase I step.~   "
217559|NCT00711581|"~     The purpose of this study is to determine the safety and efficacy of the Endograb system~     which is an internal laparoscopic retractor device. This retractor device is inserted into~     the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate~     dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal~     incisions in a laparoscopic operation.~   "
217560|NCT00711568|"~     The purpose of this study is to determine whether repetitive high field transcranial magnetic~     stimulation of the left or right frontal lobes is beneficial for the treatment of depression~     that is refractory to antidepressant medication.~   "
217561|NCT00711555|"~     The purpose of the study is to assess the effect of Emend (aprepitant) on nausea and vomiting~     associated with chemotherapy. Chemotherapy commonly causes nausea and vomiting and this~     affects patients' quality of life and attitudes toward treatment. Although nausea and~     vomiting associated with chemotherapy has been decreasing due to improved therapy, some~     patients will still experience this side effect. Therefore, new medications are needed to~     decrease the amount of nausea and vomiting patients have with chemotherapy. Emend~     (aprepitant) is a new medication used to treat nausea and vomiting with chemotherapy, but it~     has only been studied in patients receiving only one dose of chemotherapy that makes most~     people sick. However, there is little experience with this medication in patients receiving~     multiple days of chemotherapy that causes nausea and vomiting.~   "
217562|NCT00711542|"~     Coronary flow reserve is an important measure of the integrity of the coronary~     microcirculation. Moreover, impaired coronary flow reserve is a predictor of future~     cardiovascular events and poor prognosis in patients after acute myocardial infarction.~      After acute myocardial infarction, coronary flow reserve remains significantly reduced. A~     previous randomized, double-blind Placebo-controlled trial (REPAIR-AMI) demonstrated complete~     normalization of coronary flow reserve after intracoronary application of autologous bone~     marrow-derived progenitor cells (but no effect in the placebo group) in patients with ST~     segment elevation myocardial infarction. The current study is planned to extend these~     findings to patients with Non-ST segment elevation myocardial infarction, since these~     patients have an equally reduced outcome.~   "
217575|NCT00711373|"~     This is a clinical trial of unilateral and bilateral hand transplantation. This will be done~     by the surgical transfer of a hand from a non-living donor to restore function of~     non-functioning or amputated hand. Recipients must currently take the same type of drugs as a~     kidney transplant patient to prevent rejection of the hand.~   "
217593|NCT00711126|"~     This study will involve the use of a new medicine called GW642444 being developed for the~     treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the~     study is to see how safe and how well tolerated the study drug is when it is given as a~     liquid by mouth or by injection into a vein. In addition the study will measure how much of~     the medicine gets into the bloodstream when it is given by mouth, by injection into a vein~     and inhaled, and how long the body takes to get rid of it.~   "
217563|NCT00711529|"~     Premenopausal women with breast cancer who receive endocrine therapy (e.g. tamoxifen) and/or~     chemotherapy are at risk for experiencing premature menopause because of their treatment. The~     resulting symptoms, most notably hot flashes, can cause significant detriment to a patient's~     quality of life. Treatment for menopausal symptoms with the gold standard of hormone~     replacement therapy is not done routinely as it is unclear whether it can increase risk of~     tumor recurrence. In addition, many medical oncologists feel it is contraindicated in this~     population, especially among women whose breast cancers have estrogen receptors. This has~     lead to an increased interest in options other than estrogen replacement in the treatment of~     hot flashes, though most investigations of alternative medications have shown a suboptimal~     response.~      Recent studies have suggested that non-drug treatments using alternative or complementary~     therapies may be effective. Specifically, hypnosis has been promoted as a means to control~     hot flashes, though it has not been tested in a randomized fashion. In accordance with the~     National Cancer Institute's recent initiatives to expand the goals of clinical trials to~     include symptom management studies, our purpose is to evaluate the role of complementary and~     alternative therapies for improvement of symptoms in women with breast cancer. Specifically,~     we plan to evaluate the use of hypnotherapy for the treatment of therapy-induced hot flashes~     in breast cancer survivors. We intend to recruit 60 women into a pilot feasibility trial~     comparing hypnotherapy to the drug gabapentin (Neurontin®) for the treatment of~     therapy-induced hot flashes in eligible women who are receiving care at the Breast Health~     Center. We have chosen gabapentin based on recent studies showing it may be an effective~     non-estrogen treatment for this indication.~      We will identify patients who are experiencing at least one daily hot flash as a result of~     the treatment they received for their breast cancer for participation. When enrolled, they~     will be randomized into either the treatment arm, in which they will receive daily~     gabapentin, or the experimental arm, in which they will undergo weekly hypnotherapy.~      Our study hypothesis is that hypnotherapy will be more effective than gabapentin in the~     control of hot flashes in this population.~   "
217564|NCT00711516|"~     The primary objective of this study is to determine whether treatment with armodafinil will~     provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive~     Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.~   "
217565|NCT00711503|"~     A draw trial of the effect of Interleukin-1 Receptor Antagonist (anakinra, Kineret®) on the~     insulin production in patients with new onset Type 1 diabetes.~      Kineret® is already being used in the treatment of patients suffering from rheumatoid~     arthritis and preclinical studies are now suggesting that it may also be useful for patients~     with Type 1 diabetes. The active substance in Kineret is interleukin-1 receptor antagonist, a~     blocker of an immune-signal molecule named interleukin-1.~      The trial is a blinded randomised trial, in which the patient is allocated to receive the~     active drug (Kineret®) or placebo (saline). The hypothesis is that anti-IL-1 treatment as~     add-on therapy to conventional insulin therapy will preserve or enhance beta-cell function.~   "
217566|NCT00711490|"~     Objective: Diabetic macular edema (DME) is a frequent manifestation of diabetic retinopathy,~     a leading cause of blindness in the United States. The only proven treatment for DME is laser~     photocoagulation. Sirolimus has been shown to inhibit the production, signaling and activity~     of many growth factors relevant to the development of diabetic retinopathy. Therefore, this~     study will investigate the safety and efficacy of multiple sirolimus injections in patients~     with DME.~      Study Population: Eligibility criteria include central macular thickening > 260 microns and~     visual acuity 20/32 or worse in one or both eyes.~      Design: Five participants will be enrolled into this open-label pilot study. After receiving~     a 20 μL (440 μg) subconjunctival injection in the study eye at baseline and Month 2, the~     participants will be re-evaluated every two months for at least one year for possible~     additional injections. During follow-up, participants will not undergo re-injection if they~     show significant clinical improvement or treatment success, defined as no intraretinal fluid~     or cysts present on optical coherence tomography (OCT) OR 100% reduction in excess retinal~     thickness over 260 microns on OCT OR no leakage on fluorescein angiography (FA). Beginning at~     Month 4, participants will be assessed for treatment failure, defined as loss of 15 or more~     letters of vision compared to baseline at two consecutive visits OR a 50% or greater increase~     in total retinal thickness as measured by OCT at two consecutive visits. Individual~     participants deemed treatment failures will continue receiving sirolimus injections, but will~     be allowed to receive focal laser therapy for any amenable leaking microaneurysms at Month 4.~     Beginning at Month 6, focal laser therapy will be permitted for both treatment failures and~     participants who do not meet the criteria of a treatment success. Participants will have the~     option of continuing treatment until a common termination date of one year.~      Outcome Measures: The primary outcome is the change in visual acuity in the study eye at six~     months compared to baseline. Secondary outcomes include changes in visual acuity in the study~     eye at one year as compared with baseline, changes in retinal thickness as measured by OCT~     and changes in fluid leakage in the macula as demonstrated by FA at six months, one year and~     throughout the study period in the study and fellow eyes. Safety outcomes include number and~     severity of systemic and ocular toxicities, adverse events and infections, and the number of~     participants withdrawn from study therapy.~   "
217567|NCT00711477|"~     The purpose of this study was to assess the effect of naltrexone SR/bupropion SR (NB) on~     brain function in response to food cues using functional magnetic resonance imaging in~     overweight or obese subjects.~   "
217568|NCT00711464|"~     Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This~     includes many types of cognitive dysfunction, such as in attention, memory and language.~     These problems may explain why patients with schizophrenia think and act in unusual ways, and~     often have problems managing aspects of their lives that healthy adults take for granted.~     Unfortunately, the biochemical aspects of these dysfunctions are presently unknown, and it is~     not clear whether current psychiatric medications can improve these functions. A recent~     FDA-approved medication that may improve this function is modafinil. Studies in animals and~     healthy adults show that this medication can improve many of these cognitive functions. We~     plan to study the effects of modafinil on these cognitive processes, by giving various doses~     of this medication to patients before they perform tasks of these cognitive processes. We~     predict that when patients receive modafinil, they will perform better on a cognitive test,~     and that these benefits will depend on the dose given.~   "
217569|NCT00711451|"~     The purpose of this study is to evaluate whether manual removal of the placenta during a~     cesarean delivery results in higher changes in the resistance of blood flow throughout the~     body, also called systemic vascular resistance (SVR)~   "
217570|NCT00711438|"~     The aim of this study is to test the feasibility of conducting a pragmatic fast track~     Randomized Controlled Trial (RCT) of the Breathlessness Intervention Service (BIS) versus~     standard care for patients with COPD and their carers, and to begin testing the effectiveness~     of the intervention.~   "
217571|NCT00711425|"~     The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture~     Osseospeed™, in patients with tooth loss in the posterior mandible in an early loading~     protocol. Primary objectives are implant stability, marginal bone adaptation and survival~     rate.~   "
217572|NCT00711412|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin~     together with radiation therapy works in treating patients with esophageal or~     gastroesophageal junction cancer.~   "
217573|NCT00711399|"~     The study goal is to create a database of respiratory sounds recordings, to evaluate and~     validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing~     the severity of the respiratory symptoms before and after the administration of the~     treatment.~   "
217576|NCT00711360|"~     The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of~     measuring the intrathoracic impedance on a daily basis and transmission of impedance trend~     data via the Home Monitoring technology. In future, this will allow for automatic early~     detection of imminent decompensation at a presymptomatic stage and immediate initialization~     of clinical meaningful therapeutic interventions preventing heart failure related~     hospitalizations. The aim of this investigation is to record long-term impedance trends in~     heart failure patients with and without heart failure related events (hospitalizations due to~     acute decompensation) in order to develop algorithms for device-based early detection and~     warning of HF deterioration accompanied by pulmonary congestion.~   "
217577|NCT00711347|"~     An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract~     surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy~     Iris Syndrome exists.~   "
217578|NCT00711321|"~     The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE~     AD02 applied during AFFiRiS 002~   "
217579|NCT00711308|"~     The purpose of this study is to evaluate the feasibility of the long-term treatment of~     pulmonary embolism with tinzaparin compared to oral anticoagulants.~   "
217580|NCT00711295|"~     The purpose of this study is to assess the safety and tolerability of, and the immune~     response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in~     specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after~     vaccination with this vaccine will be assessed.~   "
217581|NCT00711282|"~     The purpose of this study is to evaluate the clinical performance of implants placed in~     individuals who are about to loose one or more of their upper teeth. The main objective is to~     study how the surrounding bone tissue reacts to two different shapes of implants. Clinical~     performance, in wider terms, means esthetics and long lasting function. Half of the patients~     will receive a cylindrically shaped implant and the other half will receive a~     conical-cylindrical implant. The implants will be placed and after a healing period of 16~     weeks the gum will be re-opened and the bone tissue response clinically evaluated. Permanent~     artificial tooth/teeth will be attached six weeks after that.~   "
217582|NCT00711269|"~     The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients~     with schizophrenia.~   "
217583|NCT00711256|"~     The investigators want to investigate whether sunscreen is removed by clothing and to what~     extend when the amount of sunscreen applied varies.Does clothing reduce the SPF when clothes~     are put on 20, 8, or 4 minutes after sunscreen application? The investigators also want to~     investigate the persistence of sunscreen during eight hours indoor. How much does the SPF~     reduces? Furthermore, we want to investigate whether sunscreen in the layers 2, 1, and 0.5~     mg/cm2 reduce the vitamin D production in the skin.~   "
217584|NCT00711243|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when~     given with oxaliplatin and fluorouracil and to see how well they work in treating patients~     with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other~     solid tumor.~   "
217585|NCT00711230|"~     DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a~     single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These~     particles are safe; replication, integration and reverse transcription deficient. DermaVir is~     targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with~     DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected~     cells.~      GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded,~     multicenter study to assess the safety, tolerability, immunogenicity, and preliminary~     antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with~     HIV-infection.~   "
217586|NCT00711217|"~     The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16~     weeks of consuming a medical food versus a calorically similar control drink.~   "
217587|NCT00711204|"~     A 12-week, multicenter, randomized, double-blind, placebo-controlled phase IV study.~     Approximately 200 subjects will be enrolled, half will receive active drug (donepezil~     hydrochloride) and half will receive matching placebo at approximately 50 research sites~     within the US, the European Union, South Africa and Australia. Eligible subjects will reside~     at home, in an assisted living facility, or nursing homes age and will be 50 years or older,~     with a diagnosis of Alzheimer's disease in the severe stage. All subjects must start with 5mg~     a day (one 5 mg tablet of donepezil HCL or matching placebo). Dose will be increased to 10 mg~     a day (two tablets of 5 mg donepezil HCL or matching placebo) after 4 weeks. Dose may be~     decreased based on side effects. The primary efficacy measure will be the Cornell Scale for~     Depression in Dementia (CSDD). Secondary measures will include Functional Assessment Staging~     (FAST), Mini-Mental State Examination (MMSE), NPI-10 (Neuropsychiatric Inventory), DEMQOL~     Proxy ( Quality of Life). Blood levels of cytokines and safety will also be assessed.~   "
217588|NCT00711191|"~     This study aims to seek evidence that activation of certain cells of the immune system will~     be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence~     of clinical anti-tumor activity will be sought.~   "
217589|NCT00711178|"~     A randomised, multi-center study of daylight mediated photodynamic therapy (PDT) with Metvix~     in patients with multiple actinic keratosis on the face and/or scalp.~   "
217590|NCT00711165|"~     A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.~   "
217591|NCT00711152|"~     1. To recruit 600 type 2 diabetic patients managed in a community setting.~        2. To enrol into the Joint Asia Diabetes Evaluation (JADE) Program.~        3. All patients will undergo annual comprehensive assessment (CA) at a diabetes centre with~          personalized JADE report (JADE) at basline. Half of the randomized patients will be~          managed with additional support by a trained community health worker (CHW) (JADE+CHW).~        4. All patients will undergo annual comprehensive assessments for comparison of attainment~          of treatment targets for 3 years~   "
217592|NCT00711139|"~     The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE~     AD01 applied during AFFiRiS 001~   "
217595|NCT00711100|"~     Recently, tobacco companies have developed new oral tobacco products that are purportedly~     less harmful than conventional tobacco products. These products have not been tested by~     independent research for their health effects or consumer palatability. In addition, it is~     not known if these products will be used in addition to cigarette smoking or as a substitute~     to cigarettes. These two studies will examine four oral tobacco products to answer some of~     these questions.~      The goals of this first study will be to examine: 1) the brand of oral tobacco products which~     is preferred by cigarette smokers and the pattern and amount of product use when used as a~     switching tool; 2) the characteristics that are associated with product choice; 3) nicotine~     exposure from these products; and 4) the withdrawal symptoms from the tobacco products and~     potential for continued use.~      Specifically, our primary aims hypotheses were: 1) the product that will be chosen by most~     smokers will be based on taste and sensory aspects of the product with products higher in~     nicotine content more likely to be chosen as the preferred product; and 2) subjects will~     experience no difficulty using the product for complete cigarette substitution, but a small~     minority will engage in dual product use.~      For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of~     cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly~     lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to~     be mild compared to cigarette withdrawal.~   "
217596|NCT00711087|"~     The purpose of this study is to see what the effect of Botox has on bladder function for~     those who have recently suffered spinal cord injury. We also will study bladder tissue levels~     of NGF (nerve growth factor) that can tell us how the nerves to the bladder are healing after~     injury.~      Consenting male and female cervical and high thoracic (T10 and above) SCI patients will be~     identified within the first 6-7 weeks after SCI and randomized to two external urethral~     sphincter injection groups. Each group will be injected within 8 weeks after SCI (Day 0) and~     3 months later (Day 90). The injection paradigm will consist of: Group 1-100 units of BTX-A~     (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90; Group 2-sham~     saline injections on both Day 0 and Day 90. Injections will be performed under local~     anesthesia using standard flexible cystoscopic equipment.~      Use of placebo is justified because: 1. there have been documentation of nerve~     desensitization with dry needling (i.e. acupuncture) and wet needling (i.e.~     saline)--therefore, to truly demonstrate benefit of Botox over just the needle insertion into~     the sphincter muscle or injection of the diluent saline, a sham saline injection group is~     included, 2. the injection procedure itself is minimally invasive and not expected to result~     in any complications.~      Subjects who qualify and have signed the informed consent document will be randomized into~     two groups, those receiving the BTX-A and those receiving placebo. Blinding will be performed~     by the TIRR pharmacy department who will provide Botox and placebo in identical syringes so~     that the treating staff will be blinded. Pharmacists will ensure patients receive the same~     agent at the time of the second injection. Unblinding will occur at the end of the study or~     if complications necessitate breaking of the code. Both groups will undergo urodynamic~     testing to document before and after treatment data. Bladder biopsies will be taken prior to~     treatment in both groups that will be analyzed for nerve growth factor. Three day voiding~     diaries will be kept and reviewed with the study coordinator at the follow up visits. Quality~     of life questionnaires will be completed at each follow up visit. The treatments will take~     place on Day 0 and Day 90. Follow up visits will occur at Day 120, 16 month, and 28 months.~   "
217597|NCT00711074|"~     The purpose of this study is to determine how the body breaks down and excretes the~     investigational drug, AZD5672.~   "
217598|NCT00711061|"~     The purpose of this study is to compare the cardiovascular risks of growth hormone deficient~     young adult males who have completed growth hormone therapy to healthy young adult males.~   "
217599|NCT00711048|"~     The purpose of the study is to compare sensitivity and sensitization of visceral pain in the~     esophagus using different pain stimuli~   "
217600|NCT00711035|"~     This trial is designed to evaluate the feasibility, safety and efficacy of most closely~     HLA-matched multivirus specific CTL lines (CHM-CTLs) in HSCT patients with EBV, CMV or~     adenovirus infections that are persistent despite standard therapy.~      The primary objective of the study is to assess safety and feasibility of administering CTLs.~     Survival data will be collected by asking the transplant center to submit the routine~     Transplant Essential Data form that is sent to the Stem Cell Transplant Outcomes Database at~     100 days and 1 year and includes data on survival status and other outcome measures.~   "
217601|NCT00711022|"~     The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in~     patients with totally edentulous upper jaws and poor bone quality and quantity, when~     provisional artificial teeth are attached within 24 hours. The primary objective is to~     investigate implant survival rate.~   "
217602|NCT00711009|"~     The purpose of this study is to compare the safety, tolerability, and antiviral activity of~     the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase~     inhibitors to lopinavir/ritonavir tablets when administered in combination with a human~     immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1~     infected subjects.~   "
217603|NCT00710996|"~     To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment~     levels.~   "
217604|NCT00710983|"~     Our group has discovered that routine vaccinations in childhood may have non-specific and~     sex-differential effects on overall mortality. The effects are so large that they may have~     marked effects on overall mortality and seriously distort female-to-male mortality rates in~     high-mortality settings. We recently experienced periods during which oral polio vaccine~     (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were~     following all infants as a part of a vitamin A supplementation trial. Surprisingly, we~     discovered that not receiving OPV was associated with significantly lower mortality in boys,~     but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly~     dampened the immunological response to BCG given at birth in both sexes. Based on these~     observations, receiving OPV at birth may have two negative effects, first, it may increase~     male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth~     is given for logistic reasons, to boost polio immunity. There have been no polio cases in~     Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised~     trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and~     growth and 2) immunological response to BCG.~   "
217631|NCT00710619|"~     This study is conducted in the United States of America (USA). The aim of this study is to~     investigate the at-home-administration of bypassing agents for treatment of bleeding episodes~     in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are~     further investigating how bleeding episodes affect the quality of life of the patient and~     their family or caregivers.~   "
217756|NCT00708981|"~     The purpose of this study is to compare the progression of kidney disease in subjects with~     Diabetes mellitus type 2 and Advanced Diabetic Nephropathy treated by routine follow-up as a~     general care and in subjects treated by multi-factorial intervention in the Diabetes-Renal~     Clinic.~   "
217605|NCT00710970|"~     The major objective of this two-stage phase II study is to determine whether tamoxifen is~     deserving of further study in metastatic bladder cancer. Tamoxifen is expected to function as~     a cytostatic (and not cytotoxic) agent, and may produce more disease stability than~     regression. Sustained stable disease is considered to be clinically important and the more~     likely event. Hence, 4-month freedom from progression is chosen as the primary end-point~     instead of response rate. Freedom from progression is defined as the period from start of~     therapy to the time of objective radiologic progression. A total of 25 subjects will be~     enrolled, 15 during stage 1 and 10 during stage 2 of a two-stage minimax design phase II~     study.~      Pre-therapy evaluation (within 3 weeks of initiation of therapy):~        -  History and physical examination (H and P)~        -  Performance status (PS) assessment~        -  CBC (complete blood counts)~        -  CMP (complete metabolic profile)~        -  Pregnancy test (in women younger than 50)~        -  Computed tomography (CT) scan of the chest, abdomen and pelvis~        -  Bone scan if bone pain or raised alkaline phosphatase~        -  Biopsy (may use previous biopsy specimen)~        -  Samples of plasma from the routine CBC and CMP will be banked indefinitely for future~          biomarker studies at the Scott Department of Urology.~      Treatment plan: Therapy will be administered as an outpatient. Tamoxifen is administered at~     20 mg/day as a single daily oral dose. Clinical assessment of patients by a history and~     physical examination will be performed every 4 weeks (one cycle). Objective radiological~     assessment of response will be made every 8 weeks or earlier if clinically indicated. A CT~     (computerized tomography) scan of the abdomen, pelvis and chest will be performed at baseline~     and every 2 cycles. A response is confirmed by repeating the scans in 4 weeks. Bone scan is~     performed if the patient complains of new bone pain or has raised alkaline phosphatase. A~     radiologist who is blinded to the treatment regimen reads the scans. The RECIST criteria are~     used to define response. Tamoxifen is continued until progressive disease or intolerable side~     effects occur.~   "
217606|NCT00710957|"~     Projections from NHANES III indicate that approximately 12,000,000 U.S. adults ≥ 60 years of~     age have vitamin D insufficiency (serum 25(OH)D < 50 nmol/L). A growing body of evidence~     suggests that vitamin D status may be important in biologic processes involved in the~     maintenance of physical function. To test the hypothesis that vitamin D insufficiency is~     associated with poorer muscle strength and physical performance, we propose to evaluate the~     role of vitamin D status (serum 25(OH)D) on physical function and falls in the CHS All Stars~     cohort, a population of advanced age. The specific aims are as follows:~      Specific Aim 1. To describe the prevalence and correlates of vitamin D insufficiency in~     adults of advanced age.~      Specific Aim 2. To examine the cross-sectional association between vitamin D status and~     muscle strength (leg and grip strength), physical performance (3 m/15 ft walk time, repeated~     chair stands, and standing balance), self-reported physical function (mobility, ADL and IADL~     disability), and falls.~      Specific Aim 3. To examine the longitudinal association between vitamin D status at baseline~     and incident disability (mobility, ADL and IADL disability) over 3 years of follow-up.~      Research Hypotheses: Low vitamin D status (25(OH)D < 50 nmol/L) will be associated with (a)~     lower levels of muscle strength and physical performance; (b) higher levels of self-reported~     limitations in physical function and falls; and (c) greater odds of incident disability.~   "
217607|NCT00710944|"~     The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™~     implants following immediate loading in extraction sockets versus immediate loading in healed~     ridges. Patients in need of single standing implants replacing teeth in the maxilla within~     zone 15-25 will be included and followed for 5 years. Primary objective is implant survival~     rate at 12 months.~   "
217608|NCT00710931|"~     The objective of this study is to prospectively evaluate the visual parameters in a series of~     patients after phacoemulsification cataract surgery in a series of patients bilaterally~     implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).~   "
217609|NCT00710905|"~     The objective of this study is to prospectively evaluate the visual parameters in a series of~     patients after phacoemulsification cataract surgery in a series of patients bilaterally~     implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.~   "
217610|NCT00710892|"~     Patients are being asked to participate in this study because they will be receiving a stem~     cell transplant as treatment for their disease. As part of the stem cell transplant, they~     will be given very strong doses of chemotherapy, which will kill off all their existing stem~     cells. Stem cells are created in the bone marrow. They grow into different types of blood~     cells that we need, including red blood cells, white blood cells, and platelets.~      We have identified a close relative of the patients whose stem cells are not a perfect match~     for the patient, but can be used. This type of transplant is called allogeneic, meaning~     that the cells come from a donor. With this type of donor who is not a perfect match, there~     is typically an increased risk of developing graft-versus-host disease (GvHD) and a longer~     delay in the recovery of the immune system. Seventy to ninety percent (70-90%) of people who~     receive unchanged marrow or stem cells from this type of donor will develop severe GvHD.~      GvHD is a serious and sometimes fatal side effect of stem cell transplant. GvHD occurs when~     the new donor cells recognize that the body tissues of the patient are different from those~     of the donor. When this happens, cells in the graft may attack the host organs, primarily the~     skin, liver and intestines, causing severe rashes, diarrhea, liver disease, and even death.~     GvHD is caused by a type of immune cell in the graft called T cells. Because there is a high~     risk of GvHD with the type of transplant the patient will receive, we will selectively remove~     the T cells from the graft that the patient will receive. This process, which is called CD34~     selection, is discussed in more detail in the separate consent form for the transplant.~      While this stem cell selection procedure will reduce the risk of GvHD, it will also result in~     slower recovery of the immune system. As the immune system is responsible for fighting~     infections in the body, a longer recovery time after a transplant means that the patient may~     be at increased risk for infections which can become life threatening. In some patients, the~     immune system can also fight leukemia cells and reduce the risk of relapse.~      In the laboratory, we have seen that cells made to carry a gene called iCasp9 can be killed~     when they encounter a specific drug called AP1903. To get the iCasp9 into the T cells, we~     insert it using a virus called a retrovirus that has been made for this study. The drug~     (AP1903) that will be used to activate the iCasp9 is an experimental drug that has been~     tested in a study in normal donors, with no bad side effects. We hope we can use this drug to~     kill the T cells. Other drugs that kill or damage T cells have helped GvHD in many studies.~     However we do not yet know whether AP1903 will kill T cells in humans, even though it has~     worked in our experimental studies on human cells in animals. Nor do we know whether killing~     the T cells will help the GvHD. Because of this uncertainty, patients who develop significant~     GvHD will also receive standard therapy for this complication, in addition to the~     experimental drug. We hope that having this safety switch in the T cells will let us give~     higher doses of T cells that will make the immune system recover faster. These specially~     treated suicide gene T cells are an investigational product not approved by the Food and~     Drug Administration.~   "
217611|NCT00710879|"~     This study evaluates a multi-purpose solution when used on a daily wear basis by currently~     adapted soft contact lens wearers.~   "
217612|NCT00710866|"~     The purpose of this study is to compare the antibody response and reaction rates in children~     age 6-23 months when they are given either the currently recommended schedule of two 0.25ml~     doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month~     apart.~   "
217613|NCT00710853|"~     The purpose of this study is to compare the effects of an 8-week intervention using YiRen~     Qigong, Tai Chi or Hatha yoga in older adults (age 70 and above) residing at a Gencare senior~     living facility. Outcome measures completed at the beginning and end of each intervention~     period will be blood pressure, heart rate, perceived quality of life (PQOL)and a symptoms~     questionnaire (SF-36), ability and speed of walking 20 feet (for ambulatory participants),~     and neck and arm range of motion.~   "
217614|NCT00710840|"~     Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of~     people over the age of 60 and compromises the quality of life of more than 20 million~     Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of~     the knee joint is replaced by plastic or metal, has been successful in restoring comfort and~     mobility to formerly arthritic joints. This study will compare quadriceps muscle strength,~     knee range of motion, and pain in people who have had a traditional TKA with those who have~     had a minimally invasive TKA.~   "
217615|NCT00710827|"~     To evaluate the safety and efficacy of Nebido compared to placebo in elderly men aged 50 and~     over with symptomatic late onset hypogonadism~   "
217628|NCT00710658|"~     Cancer patients often experience multiple physical, functional and psychosocial symptoms, but~     have limited support while being at home between treatments and during rehabilitation.~     WebChoice is a novel Internet support system that extends traditional health services into~     patients' homes. The system allows patients to monitor symptoms over time, and provides~     access to evidence-based self-management options tailored to their reported symptoms as well~     as a communication area where patients can ask questions to a clinical nurse specialist in~     cancer care and exchange experiences with other cancer patients.~      This randomized clinical trial:~        1. Tests the effects of WebChoice on primary outcomes of symptom distress, quality of life,~          depression and health service use, and secondary outcomes of self-efficacy, social~          support . We will also analyze:~        2. Relationships between primary and secondary outcomes;~        3. How patients' symptom distress varies over time;~        4. Patients' preferences for participation in decision making about symptom management~        5. How patients use WebChoice, such as frequency of use, duration, most used components;~        6. How patients' experience WebChoice's usefulness and ease of use;~        7. Patterns and content of patients' communication with the cancer nurse and other~          patients.~      325 cancer patients (189 breast cancer and 136 prostate cancer patients) were recruited from~     throughout Norway through advertisements and invitation letters and the Norwegian Cancer~     Registry. Patients were randomly assigned to WebChoice or the control group that received~     usual care. Patients are being followed with 5 repeated measures over 12 months. Data are~     being collected through questionnaires, from system logs, and from interviews that were~     conducted in subset of experimental group patients. The primary hypothesis will be tested~     with Repeated Measures ANCOVA techniques. The other research questions will be answered using~     various inferential and descriptive techniques and through content analysis of messages and~     transcripts of patient interviews. This study can make a significant contribution to reduce~     unnecessary suffering and improve the quality of life for a large group of cancer patients.~   "
217616|NCT00710814|"~     This is a pilot and feasibility study to examine a novel intervention using leptin in~     weight-reduced individuals who have undergone bariatric surgery but still remain obese.~     Leptin, a peptide hormone secreted from adipose tissue, is a regulator of food intake and~     energy expenditure. Administration of leptin resulted in profound weight reduction in the few~     reported cases of obese individuals with genetic leptin deficiency. However, most obese~     people have increased leptin levels. Such individuals are said to be in a leptin-resistant~     state, whereby administration of physiological concentrations of leptin are ineffective at~     producing significant weight reduction. Roux-en-Y gastric bypass surgery (RYGBP) is more~     effective than diet alone in producing long-term reduction of body weight. Yet even after~     surgery there is a plateau in weight loss though the individual may still be obese and have~     or be at risk for obesity related morbidities. The investigators have shown that plasma~     leptin levels are significantly lower in women after RYGBP compared with BMI-matched~     controls. This state of relative hypoleptinemia or leptin insufficiency suggests that~     post-RYGBP individuals may be in a leptin-sensitive state and, thus, would undergo further~     weight loss when administered doses of leptin that would not normally result in significant~     weight reduction. This study will examine the effects of leptin administered by~     self-injection twice per day on body weight and endocrine function. All individuals will~     received leptin and placebo and different times during the 34 week study period.~   "
217617|NCT00710801|"~     The purpose of this study is to learn about how different immunosuppressant therapies impact~     on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be~     evaluating if Cyclosporin A has a superior effect against recurrent Hepatitis C virus (HCV)~     infection than Tacrolimus.~   "
217618|NCT00710788|"~     Research proposal to evaluate the impact of different phosphate binders on the progression of~     cardiovascular calcification and QT dispersion in new haemodialysis patients.~   "
217619|NCT00710775|"~     The study will be conducted in patients who are undergoing surgical aortic valve replacement~     on cardiopulmonary bypass. Following surgical access of the native aortic valve and prior to~     removal of the valve, the native valve will be dilated using a standard valve dilation~     balloon. The Heart Leaflet Technologies(HLT- Heart Leaflet Technologies Inc.) aortic valve~     device will be released in the native valve and measurements will be taken of the device~     relative to the anatomic structures of the heart. Once completed, the implant is removed from~     the native valve and the surgical valve replacement procedure is completed.~      The purpose of this study is to confirm that the dimensions of the HLT valve are appropriate~     for patients with aortic valve stenosis.~   "
217620|NCT00710762|"~     The primary objective of this study is to estimate the Progression Free Survival Rates (PFS)~     of patients with relapsed ovarian cancer after 9 months of continuous treatment with either~     BIBF 1120 or matching placebo.~   "
217621|NCT00710749|"~     Crossover comparison of different flow meters with a digital home flow meter as a reference.~     Main hypothesis: Reapeated home flow measurements with a disposable device will provide a~     better understanding of the patients urinary flow than a single measurement performed in the~     clinic.~   "
217622|NCT00710736|"~     This is a Phase 1 study during which patients with advanced/metastatic solid tumors will~     receive investigational study drug ARRY-334543 and capecitabine. Patients will receive~     increasing doses of study drug in combination with capecitabine in order to achieve the~     highest dose of study drug possible that will not cause unacceptable side effects. Patients~     will be followed to see what side effects the combination causes and what effectiveness the~     combination has, if any, in treating the cancer. Approximately 30 patients from the US and~     Canada will be enrolled in this study.~   "
217623|NCT00710723|"~     In assisted reproduction technology (ART), cryopreservation of embryos maximizes the~     potential of IVF cycles. Currently different cryopreservation methods are used, the~     conventional slow freezing method and vitrification. There is, therefore an immediate need to~     assess which cryopreservation technique is preferential in human IVF. In this prospective~     randomised study conventional slow freezing and vitrification, using the Hemi-straw carrier~     system, of human day 3 embryos were compared.~   "
217624|NCT00710710|"~     The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI~     2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line~     therapy. A secondary aim is to identify the most suitable dosage regimen for the further~     phase II and III clinical programme of BI 2536. To achieve this objective, two dosage~     regimens are compared in patients receiving first line therapy.~   "
217625|NCT00710697|"~     The purpose of this study is to investigate what effects, if any, picoplatin has on the heart~     rhythm.~   "
217626|NCT00710684|"~     The study is designed to investigate the safety and efficacy of SB-742457 when added to~     stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.~   "
217627|NCT00710671|"~     The proposed study will use both qualitative and quantitative research methods (mixed~     methods) to gather data that will support the eventual development of interventions for young~     men who have sex with men (YMSM) living with behaviorally acquired HIV infection. The overall~     goal of the study is to gain an understanding of the psychosocial/developmental needs of YMSM~     by focusing on two critical developmental issues—identity development and future life goals.~   "
217629|NCT00710645|"~     This is a single-site, pilot study. In this study, we hope to learn if the Lido Workset is a~     sensitive measure of limb spasticity in patients with Multiple Sclerosis (MS). The Lido~     Workset is a FDA approved, non-invasive device which has been used to assess motor function~     and spasticity. The testing will take approximately 25 minutes. Subjects will lie down on a~     table and have a leg attached to the Lido Workset device arm. The Lido Workset will move the~     leg back and forth many times at different speeds. The Lido Workset will also analyze~     resistance to passive (while subject is not moving or resisting movement) movement of the~     wrist and knee.~   "
217630|NCT00710632|"~     RATIONALE: Screening tests may identify people with cancer who are at high risk of losing~     weight and help doctors plan better treatment.~      PURPOSE: This clinical trial is studying how well a new screening tool works in predicting~     weight loss in patients with cancer.~   "
217644|NCT00710450|"~     Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood.~     This blood will be used to be stimulated with to whatever the patient allergic. In the~     laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and~     IL-3. These are chemicals responsible for allergy symptoms.~   "
217632|NCT00710606|"~     There are over 60 million women of reproductive age in the U.S. and a majority of these women~     qualify as overweight or obese. Evidence suggests that there is an association between~     increased body weight and decreased contraceptive efficacy. Studies with the combined~     hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®)~     demonstrate higher failure rates in heavier versus lighter women.~      Weight related differences in the effectiveness of NuvaRing® need further study. A single~     secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no~     difference in pregnancy rates among women in the highest weight decile (>166#) versus the~     rest of the study population using the ring. (Westhoff, 2005) The finding of no difference,~     however, was influenced by too few obese subjects in the analysis which contributed to wide~     confidence limits. Additional studies are needed to explore how well the contraceptive ring~     functions to maintain effective serum steroid concentrations to suppress ovarian activity in~     obese women.~      This investigation focused on evaluating mean serum concentrations of hormones released in~     obese and normal weight women using the NuvaRing® . This study was a prospective clinical~     trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those~     with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined~     hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects~     (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2)~     and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers~     included sonographic evidence of follicular development and ovulation as well as circulating~     E2 levels which strongly correlate with follicular development and endometrial proliferation~     during the second month of NuvaRing® use. Assessment of these parameters will translated to~     understanding contraceptive-mediated suppression of ovarian function in these two groups.~     Subjects also logged patterns of ring use and bleeding patterns during the study period.~   "
217633|NCT00710593|"~     The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and~     behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.~   "
217634|NCT00710580|"~     Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque~     psoriasis~   "
217635|NCT00710567|"~     Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the~     DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge~     to cardiac transplantation.~      Study Population The patient population for this trial consists of patients with end stage~     heart failure awaiting cardiac transplantation. Patients must be listed for transplant with~     UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in~     the study regardless of gender, race or ethnicity.~      Study Design This is a multi-center, prospective, single arm study in which the lower~     one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur~     within an 18-month time period at up to 40 centers. All patients will be followed for all~     endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or~     death, whichever occurs first. For those patients who remain on support after 180 days,~     survival and device reliability data will continue to be collected on a regular basis. If~     patients are transplanted, survival at day 30 post cardiac transplantation will also be~     assessed.~   "
217636|NCT00710554|"~     The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in~     relieving peripheral neuropathic pain associated with allodynia.~   "
217637|NCT00710541|"~     Non-invasive ventilation is frequently applied in patients with acute exacerbation of COPD,~     but no evidence exists about the effect of long term application/home application.~      This study tests the hypothesis, that a daily, 6 hour application of non-invasive ventilation~     over one year improves survival, exercise capacity, and quality of life in patients with~     advanced stages of COPD.~   "
217638|NCT00710528|"~     The purpose of this study is to determine the dose that can be safely given to see what~     effect it may have on your cancer and to determine how the drug is distributed in the body.~   "
217639|NCT00710515|"~     The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking~     food at the same time as the capsules compared to taking capsules on an empty stomach~   "
217640|NCT00710502|"~     Cholecystectomy is one of the most common general surgery procedures performed in the US~     today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract~     disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic~     cholecystectomy was introduced in the early 1990s and has become the standard surgical~     approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy~     procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed~     as an outpatient basis and is related to a very low complication rate. Laparoscopic~     cholecystectomy requires the use of multiple trocar incisions.~      Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure~     currently being studied around the world. The idea of NOTES was developed several years ago~     in response to the concepts that patients would~        1. realize the benefits of less invasive surgery by reducing the recovery time,~        2. experience less physical discomfort associated with traditional procedures~        3. have virtually no visible scarring following this type of surgery.~      All of these advantages have spurred research and investigation forward, encouraging~     physicians and researchers to develop new equipment and techniques to use during NOTES~     procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold~     tremendous potential, there are many issues that need to be addressed before this technique~     is introduced into clinical care.~      The purpose of this study is to determine the safety, feasibility and short-term clinical~     outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with~     symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II).~      Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with~     symptomatic cholelithiasis.~      Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to~     Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis.~      Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the~     feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes~     of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal~     NOTES cholecystectomy to Laparoscopic cholecystectomy.~   "
217641|NCT00710489|"~     The purpose of the potential research study participant registry is to keep potential~     research subjects informed about any future research studies in which they may meet the~     criteria for enrollment. The purpose of this study is also to assist current and future~     clinical trials with recruitment of subjects.~   "
217642|NCT00710476|"~     In order to reach fertilization in the context of IVF, the presence of high concentrations of~     spermatozoa is associated with a higher degree of sperm metabolism and a higher concentration~     of sperm degradation products, which may adversely affect not only sperm and oocyte viability~     and the fertilization rate. The effect of a high concentration of sperm used for oocyte~     insemination appears also to be negative on embryo development (Dumoulin et al 1992*). If~     that is true, lowering the sperm concentration for oocyte insemination might improve embryo~     quality and result in a higher implantation rate per embryo. Therefore, we tested the~     hypothesis that the percentage of 8 cell-embryos on day 3 after IVF is significantly higher~     (40%) after insemination with a low sperm concentration (150 000/ml spermatozoa) than after~     insemination with a higher sperm concentration (30%; group 600 000/ml spermatozoa).~   "
217643|NCT00710463|"~     Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in~     GOLD stage IV can be optimized by application of nocturnal non invasive ventilation.~      This hypotheses shall be tested by an observational trial, comparing rehabilitation effects~     of a prospectively observed group receiving non invasive ventilation, compared wiht a~     historical control group of patients who did received the same treatment without non invasive~     ventilation.~   "
220803|NCT00668629|"~     The purpose of this study is to prove the absence of photo irritation and photo sensitivity~     potential of the product Dermacyd Tina Gel Sweet Flower.~   "
217645|NCT00710437|"~     During elective carotid endarterectomy surgery, dexmedetomidine, an FDA approved medication,~     is now given as part of our standard anesthetic regimen based upon its reported ability to~     decrease anesthetic requirements and improve the peri-operative hemodynamic profile without~     compromising the EEG monitoring that is used during these procedures. Although this is~     consistent with our clinical impression, the effects of dexmedetomidine on the perioperative~     course and EEG monitoring have not been objectively evaluated at our institution.~   "
217646|NCT00710424|"~     The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in~     relieving pain due to Diabetic Neuropathy.~   "
217647|NCT00710411|"~     The purpose of this study is to determine the inflammatory response after multiple trauma in~     humans.~   "
217648|NCT00710398|"~     Diets all share the same principle: eat less energy than you need. This results in weight~     loss. However, the weight loss is usually a combination of a loss of body fat and muscle~     mass. Additionally, one's bones may begin to weaken, albeit very slowly, while on a diet,~     which could have serious long-term consequences. Thus, the investigators believe that the~     goal of any weight loss strategy should be to lose body fat and spare muscle. The~     investigators reasoning is two-fold. 1) Fat is not only stored under the skin, but also in~     and around the internal organs. When this occurs, the organ itself may not function properly.~     Losing fat mass is a very good thing from a health standpoint, since fat is not just a~     storage site for extra energy. Scientists have now shown that 'extra' body fat itself can~     actually secrete substances and when these substances get into your blood, they cause many~     problems and may even contribute to the development of diabetes. 2) Sparing muscle as an~     individual loses weight is very important. Muscle is a very 'metabolically active' tissue and~     is, by analogy, like the body's furnace. Muscle burns fuel from the food individuals eat and~     also from stored fuels, like fat. Hence, it's easy to see why you don't want to lose muscle~     because you'd be losing one of your body's best fat burners. More importantly, muscle is also~     a big storage site and furnace for blood sugar. In people with diabetes (elevated blood~     sugar), a big part of the problem is with their muscles - they simply do not take up and~     store or burn enough sugar. For these reasons, your goal should be to lose fat and preserve~     muscle while dieting.~      There are many different diets to choose from (e.g. high protein, low carbohydrate, high fat,~     high fiber, etc.). A diet that has been shown to be quite successful, however, is one that is~     higher in protein (but not excessive). Thus, in this study, the investigators are proposing~     to test whether a higher protein (with dairy) and calcium diet promotes body fat loss and~     muscle mass retention. The investigators believe that a diet higher in protein (with an~     emphasis on dairy), but still within accepted healthy ranges, with higher dietary calcium may~     result in greater loss of body fat and retention of muscle than a diet with a conventional~     amount of protein and adequate calcium or a conventional amount of protein with little~     calcium (i.e. low dairy). Based on previous research, the investigators think that people~     with low calcium intakes to begin with would stand to benefit the most. There is also a good~     reason to think that the high protein/high calcium diet may result in greater reductions in~     blood cholesterol and blood sugar, both of which would reduce a person's risk for heart~     disease and diabetes.~      The investigators will test this diet in premenopausal women who are overweight or obese. The~     investigators believe that this group is a good one to target for several reasons. First,~     women of this age who are overweight or obese are, if they continue to carry this excess~     weight, are at serious risk for developing chronic diseases such as heart disease, diabetes,~     and possibly cancer at an early age. Second, these women will often begin to gradually~     consume less dairy because many perceive dairy foods as fattening. Thus, if the investigators~     proposals are correct the investigators will hopefully be able to equip health professionals~     with a tried and tested, palatable, dietary strategy in a population segment who, because of~     their age, would benefit greatly were their disease risk to be reduced.~   "
217649|NCT00710385|"~     The study is designed to compare the abuse liabilities of intravenous buprenorphine and~     buprenorphine/naloxone in individuals who are physically dependent on sublingual~     buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower~     than that of buprenorphine alone.~   "
217650|NCT00710372|"~     The study medication CYT006-AngQb is a vaccine, consisting of angiotensin II (Ang II), the~     naturally occurring octapeptide coupled onto the surface of virus-like particles (VLP). This~     form of presenting Ang II to the immune system induces a B-cell mediated immune response~     characterized by the generation of specific antibodies (IgG and IgM) against Ang II. The~     CYT006-AngQb vaccine is administered by subcutaneous (s.c.) injection. Immunization against~     angiotensin II may offer a valuable alternative to conventional drugs for the treatment of~     hypertension.~   "
217651|NCT00710359|"~     During fetal life and infancy, an adequate cobalamin status is important for normal growth~     and central nervous system development. During the last years we have detected cobalamin~     deficiency in a number of infants admitted to the Pediatric Department with various symptoms,~     including neurological symptoms and feeding problems. Cobalamin treatment is given to the~     infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved~     physical condition.~      In this study we want to establish the prevalence of cobalamin deficiency in infants with~     gastrointestinal symptoms and/or feeding problems. Cobalamin status will be investigated in~     all children aged 8 months and younger, admitted to the Pediatric Department with these~     symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin~     supplementation in children with these symptoms and metabolic evidence of impaired cobalamin~     status.~      Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin~     deficiency, will lead to loss of symptoms and in improved physical condition.~   "
217652|NCT00710346|"~     The purpose of this study is to collect information and tissue samples from women with~     uterine fibroids. The samples will be used to study genes, proteins and other substances in~     order to better understand the disease process and improve fertility and reproductive health.~      Women who are scheduled to undergo hysterectomy, myomectomy or other surgery due to uterine~     fibroids or to an unusual variant of fibroid disease, such as HLRCC or benign metastasizing~     leiomyomatosis, may be eligible for this study.~      Tissue samples are collected from participants during surgery. The samples are coded and~     catalogued for research use. Data collected regarding the surgery include the sample~     location, surgery type, reason for surgery and the primary and secondary diagnoses.~     Additional data collected about the participant include date of birth, race, ethnicity,~     weight, height, smoking status, information about menstrual cycles, medications and family~     history.~   "
217653|NCT00710333|"~     This trial will assess the safety and efficacy of 500ng Juvista per linear cm of wound margin~     administered by intradermal injection following the excision of keloid scars on the ear lobe.~     Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for~     patients as they are very difficult to conceal and are usually bilateral. As the recurrence~     rate and growth rate of keloids can vary significantly between individuals, trial subjects~     will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be~     treated with Juvista following keloid excision and one with placebo.~   "
217654|NCT00710320|"~     We aim that uncovering patients during induction of general anesthesia does not decrease core~     body temperature in pediatric patients.~   "
217655|NCT00710307|"~     The purpose of the protocol is to describe the distribution of IGF-1 deficiency in the~     studied population of Idiopathic Short Children without Growth Hormone Deficiency or any~     other identified cause of short stature and not treated with recombinant Growth Hormone or~     IGF-1~   "
217656|NCT00710294|"~     This clinical investigation is designed to describe the long-term safety and efficacy of the~     CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the~     DEBuT-HT study beyond the original follow up period (4-months or longer). The information~     obtained in this trial is intended to support regulatory approvals and market release of this~     therapy.~   "
217657|NCT00710281|"~     Using phase contrast MR Angiography with NOVA® Software, this study intends to~     identify,evaluate and map intracranial aneurysm development as well as develope a predicator~     for future morphological changes of aneurysms and possible risk of future rupture.~   "
217658|NCT00710268|"~     Phase I, open label, dual centre, dose finding study to evaluate the safety and tolerability~     of continuous twice daily oral dosing with AZD2281 when administered in combination with~     Bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.~   "
217659|NCT00710255|"~     This research is being conducted to help us better understand what causes exercise induced~     asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and~     adenosine, play an important role. The investigators will be measuring these chemicals in the~     exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic~     exercise induced asthma. The investigators will determine how the levels of these chemicals~     change in association with how lung function changes before, during and after an episode of~     exercise induced asthma.~   "
217660|NCT00710242|"~     The study is a Proof-of-concept study to evaluate if DF01 can prevent protracted labor. Time~     to delivery will be measured from the time of at least 3 cm cervix dilatation and 3~     contractions of minimum one minute's duration/10 minutes.~   "
217757|NCT00708968|"~     The purpose of this study is to determine if a family-based intervention (The FOCUS Program)~     can improve the long-term quality of life and other psycho-social outcomes of men with~     prostate cancer and their spouses.~   "
217661|NCT00710229|"~     Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in~     age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most~     important factor involved in this angiogenetic processes in the eye. This forms the basis for~     new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the~     FDA and one drug is used off-label. All these drugs are administered intravitreally. The~     present study aims to directly compare the effects ranibizumab and bevacizumab in a~     randomized controlled study in patients with neovascular AMD.~   "
217662|NCT00710216|"~     This study examines the effect of telbivudine compared to lamivudine on the early viral~     kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral~     load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.~   "
217663|NCT00710203|"~     DPN is a disorder among darkly pigmented patients, manifested by small, benign, variants of~     seborrheic keratoses, predominantly on the face.~      The purpose of this study is to determine the efficacy of a 585 nm PDL for the treatment of~     Dermatosis Papulosa Nigra, and compare it to therapy with curettage (scraping the lesions~     off) and electrodesiccation (burning the lesions off).~   "
217664|NCT00710190|"~     The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex~     Hypertension Therapy System in patients with refractory hypertension.~   "
217665|NCT00710177|"~     The purpose of this study is to determine if normally occurring variations in a specific gene~     called PTGS-1 are associated with an increased risk of narrowing of the ductus arteriosus~     from exposure to over-the-counter pain medicines (NSAIDs).~   "
217666|NCT00710164|"~     This study will determine if Xiaoshuanchangrong (XSCR) capsule will improve recovery from an~     acute stroke. The study is designed to look at both overall recovery and recovery of motor~     function, for example muscle strength and coordination.~   "
217667|NCT00710151|"~     This research is being done to investigate cognition in long term survivors of Primary~     Central Nervous System Lymphoma (PCNSL). Sometimes caregivers as well as patients who no~     longer have the disease report cognitive problems such as reduced memory or attentional~     dysfunction and decreased quality of life. Unfortunately, little is known about what may~     contribute to this cognitive dysfunction in part because PCNSL is a rare disease and~     sensitive tests have not often been used in the research studies. This project is being~     conducted to help understand what factors, such as radiation, may contribute to cognitive~     dysfunction and better define the relationship between brain structure and thinking in people~     who have had PCNSL.~   "
217668|NCT00710138|"~     During fetal life and infancy, an adequate cobalamin status is important for normal growth~     and central nervous system development. During the last years we have detected cobalamin~     deficiency in a number of infants admitted to the Pediatric Department with various symptoms,~     including neurological symptoms and feeding problems. Cobalamin treatment is given to the~     infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved~     physical condition.~      In this study we want to establish the prevalence of cobalamin deficiency in infants with~     developmental delay and regression and other vague neurological symptoms. Cobalamin status~     will be investigated in all children aged 8 months and younger, admitted to the Pediatric~     Department with these symptoms. In a randomised intervention trial we will evaluate the~     effect of cobalamin supplementation in children with these symptoms and metabolic evidence of~     impaired cobalamin status.~      Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin~     deficiency, will lead to loss of symptoms and in improved physical condition.~   "
217669|NCT00710125|"~     This is a Phase 1 safety and dose escalation study to define the maximum tolerated dose (MTD)~     and identify the dose limiting toxicities (DLT) following IV administration of GPX-150 once~     every 3 weeks. Escalating doses starting at the dose of 14 mg/m2 and increasing to the dose~     of 265 mg/m2 will be administered IV once every 3 weeks for up to 8 cycles of treatment.~     Patients who have previously received an anthracycline are limited to 4 cycles of treatment.~   "
217670|NCT00710112|"~     The purpose of this study is to determine if sequence variations in genes involved in the~     development and function of vulnerable organs increases susceptibility to chronic lung~     disease (CLD) and other diseases affecting premature infants, such as necrotizing~     enterocolitis (NEC), sepsis, patent ductus arteriosus (PDA) and intraventricular hemorrhage~     (IVH). The study will also determine whether measurement of certain biomarkers in serum will~     identify infants who will develop these complications of prematurity. Previous studies from~     this institution and others have identified genetic variants in some genes, such as toll like~     receptor genes are associated with higher risk of CLD or NEC. The interaction of these~     variants with other gene variants that can influence the risk of these diseases remains~     unclear.~   "
217671|NCT00710099|"~     Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study~     investigates cutaneous microcirculation when we associate sildenafil per os with SNP via~     iontophoresis.~   "
217672|NCT00710086|"~     Labor analgesia is an essential health caring procedure for women. However, epidural~     analgesia cannot be performed on all subjects for different contraindications, such as lower~     platelet counter, back infection at the puncture site, and fear of epidural injection etc.~     Therefore, intravenous analgesia is an alternative for such conditions. Given the influence~     of intravenous administration of drugs on fetus, the drug selection is very important.~     Remifentanil, a super-short efficacious opioid, can last for 3-4 minutes after injection,~     which is similar in both maternal and fetal environment. Thus the fetus-associated side~     effects would be less than other drugs. The investigators hypothesized that remifentanil~     would be a superior intravenous drug used with patient-controlled technique for labor~     analgesia.~   "
217673|NCT00710073|"~     Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians~     once conventional therapies fail.~      We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in~     men.~   "
217674|NCT00710060|"~     This study will evaluate the effectiveness of a community-level HIV prevention program in~     promoting safer sexual behaviors and reducing the transmission of HIV/sexually transmitted~     diseases among at-risk populations in China, India, Peru, Russia, and Zimbabwe.~   "
217675|NCT00710047|"~     The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg~     single oral dose of ZD4054 (Zibotentan)~   "
217676|NCT00710034|"~     For the primary goals, we hypothesize that 1) the oral tobacco product will be more~     efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2)~     among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette~     smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal~     nicotine use will be observed during and beyond the treatment period.~      For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal~     symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced~     dramatically when smokers switch from cigarettes to each of these products; however, this~     reduction will be greater with the use of medicinal nicotine.~   "
217677|NCT00710021|"~     The purpose of this study is to explore the impact of vitamin D3 on the expression of alpha~     interferon (IFN alpha) expression in systemic lupus erythematosus (SLE) patients with vitamin~     D deficiency.~   "
217678|NCT00710008|"~     First degree relatives of type 2 diabetic patients (T2DM) suffer an increased risk of~     developing this disease themselves, starting with impaired insulin sensitivity. This risk can~     be minimized by lifestyle interventions such as regular exercise training. Until this day,~     little is known about the short-term effects of exercise training on insulin sensitivity and~     the lipid content of the liver and skeletal muscle.~   "
217679|NCT00709995|"~     This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in~     metastatic Renal Cell Cancer.~   "
217680|NCT00709982|"~     The purpose of the study is to assess the effect of folic acid administration on the blood~     level and the breakdown products of OC study drug (250 mcg norgestimate[NGM]/35 mcg Ethinyl~     Estradiol [EE]) tablets. The effect of study drug tablet intake on the blood level of folic~     acid is also determined.~   "
217681|NCT00709969|"~     This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose~     regimen) in African infants / children with acute uncomplicated falciparum malaria.~   "
217682|NCT00709956|"~     Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial~     pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human~     immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional~     class II to IV at baseline, naive to PAH treatment or currently being treated with a stable~     dose of either bosentan, ambrisentan or sildenafil will be enrolled in the PROWESS 15 study.~     This randomized, double blind, placebo-controlled, crossover, and single-dose study will~     determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise~     capacity compared to placebo in patients with pulmonary arterial hypertension (PAH).~   "
217683|NCT00709930|"~     This study will evaluate the efficacy and safety of weak extremely low frequency~     electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.~   "
217684|NCT00709917|"~     This study is conducted in Europe.~      The aim of this observational study is to investigate the switch from metformin alone to~     metformin combined with repaglinide in type 2 diabetic patients not achieving adequate~     glycaemic control on maximal dose of metformin given alone and to analyse different~     epidemiological parameters.~   "
217685|NCT00709904|"~     The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC)~     injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an~     initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having~     undergone hip fracture surgery.~      The secondary objective is to evaluate the safety of extended AVE5026 administration.~   "
217686|NCT00709891|"~     This study provided data on the performance of the Cobas® 4800 HPV Test for identifying~     histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was~     conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom~     approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage~     (ECC) at baseline. These subjects included women with cytology that is 'not normal' and a~     selection of those with 'normal' cytology who entered a follow-up phase and underwent~     cytological evaluation annually for 3 years. In this follow-up phase, colposcopy and~     biopsy/ECC were performed only in women with cervical cytology considered 'not normal' at any~     of the annual follow-up visits.~   "
217687|NCT00709878|"~     The purpose of this study is to characterize the microscopic findings of skin rash associated~     with the use of chemotherapeutic anticancer agents known as epidermal growth factor~     inhibitors (EGFRIs).~   "
217688|NCT00709865|"~     The purpose of the current study is to assess the safety and tolerability of intravenous~     tonapofylline.~   "
217689|NCT00709852|"~     This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called~     gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look~     at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol~     when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol~     Injection will be compared to the results of MR images taken without contrast and with the~     results of the MR images taken with ProHance.~   "
217690|NCT00709839|"~     The purpose of this study is to investigate the effect of hydrocortisone on glucose-induced~     insulin secretion and sensitivity, by means of an intravenous glucose tolerance test with~     frequent sampling (FSIGT) followed by minimal model analysis. In a randomized single-blind~     cross-over design, the subjects will receive either hydrocortisone or placebo 4 minutes~     before an intravenous glucose load.~   "
217691|NCT00709826|"~     This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with~     placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.~   "
217714|NCT00709527|"~     The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic~     profile of multiple doses of ARC1905 intravitreous injection when administered in combination~     with multiple doses of Lucentis® 0.5 mg/eye, or with one induction dose of Lucentis 0.5~     mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related~     macular degeneration (AMD).~   "
217715|NCT00709514|"~     The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WH1 ointment~     in wound closure as compared to vehicle control when applied topically to chronic diabetic~     foot ulcers for 12 weeks. The secondary objective of this study is to collect safety~     information of DCB-WH1 ointment.~      This is a randomized, double-blind, parallel group, vehicle-controlled, multi-center study of~     DCB-WH1 ointment applied topically to grade 1 foot ulcers (according to Wagner grading~     system) in 50 subjects with diabetes mellitus.~   "
217692|NCT00709813|"~     Patient-provider shared decision making and the inclusion of patients' illness experiences~     and preferences in patient care are prioritized areas in health care. CHOICE is a~     computer-based support system for patient-centered symptom management of cancer patients~     developed for this purpose. In this randomized clinical trial at Rikshospitalet-~     Radiumhospitalet HF 145 adult stem-cell transplantation and newly diagnosed lymphoma and~     leukemia patients used CHOICE for assessments of their symptoms, problems and priorities for~     care at in-and outpatient visits during treatment and rehabilitation. In the experimental~     group this information was shared with physicians an nurses for subsequent care planning, but~     not in the control group.~      This study tested effects of CHOICE on symptom- related patient care and outcomes of symptom~     relief, patients' needs for care over time and patient satisfaction;(2) analyzed how~     patients' symptoms, needs for care varied during illness/treatment stages; and (3) evaluated~     CHOICE' ease of use and user satisfaction. Controlling for gender, age, diagnosis, and~     type/stage of treatment, education, depression, health related quality of life, and social~     support, repeated measurement models were used to test differences and variations in outcome~     variables within and between groups and over time.~   "
217693|NCT00709800|"~     The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled~     in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations~     with a needle and will be followed for 6 months to evaluate the safety of and the immune~     system's response to the vaccine. The safety and immune system response will be studied~     throughout the trial.~   "
217694|NCT00709787|"~     To assess the pattern of hypertension in the population in terms of presence of additional~     risk factors (ARF) and cardiovascular risk stratification.~   "
217695|NCT00709774|"~     The aim of this study is to investigate the effects of the right ventricular septal pacing on~     left ventricular function compared with right ventricular apical pacing.~   "
217696|NCT00709761|"~     This is an open-label, single-arm, multi-center, Phase II study to determine the activity of~     nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2~     overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study.~     Subjects will receive nab-paclitaxel (100 mg/m2 intravenously once weekly for 3 weeks,~     followed by a rest week in a 4-week cycle) plus lapatinib (1000 mg once daily). Subjects will~     receive treatment until disease progression or withdrawal from the study. The primary~     objective of this study is to evaluate overall tumor response rate of lapatinib in~     combination with nab-paclitaxel administered in women with ErbB2 overexpressing MBC who have~     received no chemotherapeutic regimen in the metastatic setting. Secondary objectives include~     progression-free survival, overall survival, duration of response, time to response and time~     to progression and safety. Safety and efficacy assessments will be performed at 8 and 12 week~     intervals, and at the end of treatment.~      Subject: Metastatic Breast Cancer, ErbB2, First-line therapy, Lapatinib, Nab-paclitaxel~   "
217697|NCT00709748|"~     The purpose of this study is to determine whether transcutaneous electrical nerve stimulation~     (TENS) delivered via the Empi Select TENS device provides relief of chronic lower back pain.~   "
217698|NCT00709735|"~     The consolidation of learning is enhanced by adrenalin and other stress hormones. This memory~     enhancing effect is opposed by propranolol. In posttraumatic stress disorder (PTSD), a~     psychologically traumatic event may overstimulate stress hormones such as adrenalin, which in~     turn overly strengthen consolidation of the memory of the event, leading to an excessively~     powerful and persistent memory. Administration of propranolol after a psychologically~     traumatic event could reduce subsequent PTSD. Unfortunately, there exists a window of~     opportunity for influencing the consolidation of a traumatic event into long-term memory. In~     persons who have already developed PTSD, this would have closed months or years earlier.~     However, recent developments in animal research suggest that reactivation (retrieval) of a~     consolidated memory can return it to a labile state, from which it must be restabilized in~     order to persist. This process, which has been termed reconsolidation, can be reduced in~     animals by propranolol.~      In a preliminary study performed by the PI and colleagues in Canada, civilian participants~     with PTSD described the traumatic event during a script preparation session, which served to~     reactivate their traumatic memory. They then received either propranolol or placebo. A week~     later, during script-driven imagery of their traumatic events, physiologic responses were~     smaller in the participants who had received post-reactivation propranolol compared to~     placebo, suggesting that the traumatic memory had been weakened by the propranolol. These~     results suggest that that post-reactivation propranolol recapitulates its effects on~     consolidation, this time by blocking reconsolidation of the traumatic memory.~      Several important questions remain unanswered. First, does propranolol also weaken traumatic~     memories in combat-related PTSD? Second, does this weakening effect only occur when the~     propranolol is given after combat memory reactivation? If not, this would refute the~     reconsolidation hypothesis and suggest that propranolol affects non-specific mechanisms.~     Third, how long does the traumatic memory weakening last?~      The proposed project will investigate these questions by performing an improved,~     double-blind, placebo-controlled study in Iraq and Afghanistan veterans with combat-related~     PTSD. Participants will be randomly assigned to one of two groups: post-reactivation~     propranolol or non-reactivation propranolol. Participants in the non-reactivation propranolol~     group will receive propranolol in the absence of traumatic memory reactivation. Participants~     randomized to the post-reactivation propranolol group will receive matching placebo capsules.~     Two days later, all participants will return for a script preparation session, at which time~     they will describe the details of their traumatic event. Participants randomized to the~     post-reactivation propranolol group will then receive propranolol, whereas participants~     randomized to the non-reactivation propranolol group will receive placebo. Participants will~     then return for psychophysiologic script-driven imagery testing one week and six months~     later. We hypothesize that those who receive propranolol after reactivation of their memories~     of their traumatic combat event(s) will show significantly smaller psychophysiologic~     responses during script-driven imagery testing compared to participants who receive~     propranolol in the absence of combat memory reactivation, supporting the inference that~     post-reactivation propranolol blocks the reconsolidation of traumatic combat memories.~   "
217699|NCT00709722|"~     The aim of the open multi-center study is to determine an efficient and safe dose and dosing~     schedule of NKT-01 in induction of response in treatment of lupus nephritis.~   "
217700|NCT00709709|"~     Many recent publications have reported encouraging results on diagnostic cardiac multislice~     CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and~     3) intrastent restenosis.~      These single center studies were made on a limited number of patients (range, 50-130) and~     focused mainly on one of the indications mentioned above.~      Moreover, results were often given after exclusion of low quality examinations. At last, no~     study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in~     these populations.~   "
217701|NCT00709696|"~     The purpose of this study is to test the ways that a drug called varenicline helps smokers to~     quit smoking. Varenicline is also called Chantix® and is approved by the United States Food~     and Drug Administration (FDA) to help people quit smoking. We will test how varenicline works~     by having you quit smoking and complete tasks that assess how you think and feel. We predict~     that varenicline help reduce anxiety, improve attention and concentration, and reduce how~     satisfying cigarettes are.~   "
217702|NCT00709683|"~     This study is conducted in Africa. The aim of this observational study is to evaluate the~     incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice~     conditions.~   "
217703|NCT00709670|"~     The aim of this study is to define the best prognostic strategy for patients presenting~     suspected acute CORONARY syndrome, between MSCT and stress echocardiography.~   "
217716|NCT00709501|"~     The purpose of the study is to determine whether using a web-based weight loss website can~     help overweight individuals lose weight.~   "
217704|NCT00709657|"~     Age related macula degeneration is one of the most common sight threatening diseases of the~     elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of~     pathological vessels, which lead to leakage, bleeding and macular edema. Several lines of~     evidence suggest that vascular endothelial growth factor (VEGF) plays a key role in the~     induction CNV. Recent evidence indicates that overexpression of VEGF in the retinal pigment~     epithelium may lead to the development of CNV in experimental models, and intravitreal~     injection of a VEGF blocker prevents the development of experimental CNV. This hypothesis is~     also supported by the promising effects of anti-VEGF treatment in patients with choroidal~     neovascularisation. The substances currently in clinical use include ranibizumab (Lucentis®),~     bevacizumab (Avastin®) and pegaptanib (Macugen®).~      However, from a physiological point of view, VEGF also serves as a survival factor for~     existing vessels and for neuronal cells. Moreover, it has been reported that VEGF induces~     vasodilatation, most probably by an increased production of nitric oxide. Accordingly one may~     hypothesize that anti-VEGF treatment is associated with ocular vasoconstriction with unknown~     long term results. Thus, in the current study, the investigators set out to investigate~     whether the ocular perfusion is affected by a single intravitreal anti-VEGF.~   "
217705|NCT00709644|"~     The purpose of the study is to determine the bioequivalence of Norgestimate (NGM) and Ethinyl~     Estradiol (EE) in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1~     containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of~     250 mcg NGM/25 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered~     alone is characterized.~   "
217706|NCT00709631|"~     Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or~     malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of~     healing despite 3 months of adequate treatmentSecondary aims of the study : to evaluate the~     interest of immunostainings for desmogleins 1-2 and p16 on biopsies to differentiate between~     pseudo epitheliomatous hyperplasia and squamous cell carcinoma ; and the prognosis of~     diagnosed carcinomas at 12 monthsStudy hypothesis : systematic biopsies of hard-to-heal leg~     ulcer may help to detect ulcerated carcinomas misdiagnosed as vascular ulcer or malignant~     degeneration of leg ulcer.~   "
217707|NCT00709618|"~     This is an open-label, single-arm, multi-center, Phase II study to determine the activity of~     vinorelbine plus lapatinib in either first- or second-line setting in women with ErbB2~     overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study.~     Subjects will receive vinorelbine intravenously once weekly for 3 weeks, followed by a rest~     week in a 4-week cycle) plus lapatinib daily. Subjects will receive treatment until disease~     progression or withdrawal from the study. The primary objective of this study is to evaluate~     overall tumor response rate of lapatinib in combination with vinorelbine. Secondary~     objectives include progression-free survival, overall survival, duration of response, time to~     response and time to progression and safety. Safety and efficacy assessments will be~     performed at 4, 8 and 12 week intervals, and at the end of treatment.~      Subject: Metastatic Breast Cancer, ErbB2, First-line or Second-line therapy, Lapatinib,~     Vinorelbine~   "
217708|NCT00709605|"~     This study will compare the immune response and side effects of an experimental HIV vaccine~     given by two different methods of administration by needle injection or by use of a~     needle-free device called the Biojector 2000 (Registered Trademark). The vaccine, called~     VRC-HIVADV014-00-VP, or rAd5, is made using an adenovirus that has been modified to contain~     DNA that codes for three HIV proteins. It cannot cause HIV or adenoviral infections.~      Healthy volunteers who are not infected with the HIV virus may be eligible for this study.~     Subjects are recruited for two study groups: Group 1 comprises volunteers who are 18 to 50~     years old and have never received an HIV vaccine and Group 2 comprises volunteers who are 18~     to 55 years old and participated in a prior study in which they received at least one~     injection of the study rAd5 vaccine.~      Subjects in both groups are randomly assigned to receive the vaccine by needle or Biojector~     2000 (Registered Trademark) into a muscle in the upper arm. They call a study nurse 2 days~     after the injection, record their temperature and symptoms on a diary card at home for 5 days~     after the injection for later review, and visit the clinic two weeks after the injection for~     a checkup.~      The injection is given on the day of enrollment. Additional visits are scheduled at weeks 2,~     4, 12 and 24, when subjects are checked for health changes or problems, their use of~     medications and how they are feeling. Blood samples are collected at all clinic visits.~     Subjects are tested for HIV at the beginning and end of the study, are asked about their~     sexual behavior and drug use, and are counseled about HIV risk reduction. Women are tested~     for pregnancy at the beginning and end of the study.~      Participants in Group 2 may undergo apheresis at the 4-week visit. This procedure is done to~     collect white blood cells for tests to examine the immune response to the vaccine. Blood is~     collected through a needle in the vein of one arm and directed through a machine that~     separates the cell components. The white cells are removed and the rest of the blood is~     returned through the same needle.~      Subjects are asked about any social effects they may have experienced from participating in~     the study. These effects are monitored to make sure participants receive any needed~     assistance and to learn ways to prevent these problems in the future.~   "
217709|NCT00709592|"~     One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal~     Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem~     cells to replace the tumor cells.~   "
217710|NCT00709579|"~     Methodology :Phase III study, single centre, double blind, versus excipient, randomised,~     controlateral design.~      Selection of the patients :Number of subjects required 60 :~        -  30 patients needing an oral corticotherapy~        -  30 patients needing a topical corticotherapy~   "
217711|NCT00709566|"~     Hip osteoarthritis is a major cause of disability and reduced quality of life. Physiotherapy,~     which encompasses a range of interventions such as exercise therapy, manual therapy,~     education and electrophysical agents, is a core component of management. To date, exercise~     therapy to date has the greatest evidence of effect . However, this evidence is limited as~     only a short-term benefit has been identified and improvements in pain and function decline~     over time. There is some limited evidence for a beneficial effect of manual therapy over~     exercise. However, clinically these interventions are used in combination, not in isolation.~     To date, no research has investigated the combined effect of exercise and manual therapy in~     hip OA.~      A multi-centre randomised controlled trial that compares the clinical effectiveness of a~     combination of manual therapy and exercise to exercise therapy only will be conducted.~   "
217712|NCT00709553|"~     The purpose of the study is to to assess the effect of multiple oral doses of ZD4054~     (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male~     subjects.~   "
217713|NCT00709540|"~     This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study~     to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in~     healthy postmenopausal women.~   "
217717|NCT00709488|"~     This is a phase 1 study to evaluate the safety and effectiveness of using the Litx™ BPH~     System in patients with LUTS due to benign prostatic hyperplasia (BPH).~   "
217719|NCT00709462|"~     This research study is for individuals who have advanced breast, colon, pancreatic, ovarian~     or bladder cancer. Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine)~     to see if it can be used to make the immune system attack the cancer. The study includes~     administration of additional treatments, in combination, thought to enhance the immune~     response effect. (CDX 1307-01)~   "
217720|NCT00709449|"~     A number of common eye diseases such as age-related macular degeneration and glaucoma are~     associated with ocular perfusion abnormalities. Although this is well recognized there is not~     much possibility to improve blood flow to the posterior pole of the eye in these diseases.~      For many years, moxaverine has been used in the therapy of perfusion abnormalities in the~     brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the~     drug, but also on the rheological properties of red blood cells. In a recent study the~     investigators have shown that intravenous moxaverine increases choroidal blood flow in~     healthy young subjects. The present study aims to investigate, whether moxaverine also~     improves blood flow in the diseased eye after systemic administration.~   "
217721|NCT00709436|"~     The purpose of this research study is to evaluate the safety and analgesic efficacy of~     PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain~     following orthopedic trauma, injury, or surgery.~   "
217722|NCT00709423|"~     A number of common eye diseases such as retinal artery and vein occlusion, diabetic~     retinopathy, age-related macular degeneration, glaucoma and anterior ischemic optic~     neuropathy are associated with ocular perfusion abnormalities. Although this is well~     recognized there is not much possibility to improve blood flow to the posterior pole of the~     eye in these diseases.~      Since many years, moxaverine is used in the therapy of perfusion abnormalities in the brain,~     the heart and the extremities. This is based on a direct vasodilator effect of the drug, but~     also on the rheological properties of red blood cells. Whether moxaverine affects blood flow~     in the eye is unknown. The present study aims to investigate whether moxaverine may improves~     blood flow in the eye after systemic administration.~   "
217723|NCT00709410|"~     The purpose of this study is to conduct cholera vaccinations in high-risk populations in~     Zanzibar in order to estimate herd protection conferred by the vaccine,estimate effectiveness~     of the vaccine, and describe the interaction of vaccination and improved water supply on the~     burden of cholera and diarrhoeal diseases.~   "
217724|NCT00709397|"~     This study is designed to determine how quickly HIV-1 is cleared from the blood in~     treatment-experienced patients beginning a salvage therapy regimen that includes the~     integrase inhibitor raltegravir. The hypothesis is that HIV-1 is cleared as rapidly in these~     patients as in treatment-naive patients starting a raltegravir-based regimen.~   "
217725|NCT00709384|"~     The investigators performed a prophylactic peroperative linear lesions connecting the~     tricuspid annulus with a right atriotomy and the atriotomy with the inferior caval vein to~     prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital~     heart disease. Conduction time between electrodes placed on both sides of the lesions is~     measured on the second postoperative day. Coronary angiography and electrophysiology study~     using an electroanatomic mapping system to assess conduction across the line are performed~     three month after the operation.~   "
217726|NCT00709371|"~     The purpose of this study is determine if the combination of zonisamide SR and bupropion SR~     are is more effective than either drug given alone or placebo in the treatment of obesity.~   "
217727|NCT00709358|"~     The primary purpose is to improve and quicken the microbial diagnosis in severe infections,~     since only one third of the cases are documented by blood cultures and adequate~     anti-infective therapy in the 48 hours reduced mortality and morbidity.~      Our hypothesis is that detection of microbial DNA in blood by real time PCR may increase the~     number of cases diagnosed for bacteraemia or fungemia and shorten the time to positive~     results, which will provide information for an adequate anti-infectious therapy.~   "
217728|NCT00709345|"~     This study will evaluate the effectiveness of a cognitive behavioral treatment in reducing~     significant medical risk factors often associated with people who have a serious mental~     illness and are taking atypical antipsychotic medications.~   "
217729|NCT00709332|"~     The purpose of the study is to assess the effect of folic acid administration on the blood~     level and the breakdown products of oral contraceptive (OC) [250 mcg NGM/35 mcg EE] tablets.~   "
217730|NCT00709319|"~     The study is designed as a prospective cohort study to assess changes in visual acuity and~     retinal thickening and surgical complications in subjects undergoing vitrectomy for diabetic~     macular edema.~      The study also aims to identify subgroups in which there appears to be a benefit of~     vitrectomy and subgroups in which vitrectomy does not appear to be beneficial and to obtain~     data that can be used to plan a randomized trial.~      Subject will be followed through 2 years, with a primary outcome at 6 months post vitrectomy~     surgery. The vitrectomy procedure will be performed based on the investigators usual care and~     is not considered part of the research although the procedure performed will be collected.~   "
217731|NCT00709306|"~     The purpose of the proposed project is to investigate the efficacy and longevity of two novel~     approaches to changing skin protection behaviors: 1) UV-detect photos that reveal currently~     existing skin damage and 2) motivational interviewing (MI), a person-centered, yet directive~     counseling style used to enhance internal motivation to change health behaviors. The proposed~     investigations include a pilot study to refine the methodology; a small formal randomized~     controlled efficacy trial; and a dismantling study. These studies will also expand current~     knowledge and research in several major ways: 1) the use of UV-detect photos will enable~     highly salient and personalized feedback, 2) MI will be used in a previously untried health~     domain (skin cancer prevention), 3) objective skin color changes will be measured using~     state-of-the-art skin reflectance spectrophotometry, and 4) the proposed studies will test~     aspects of several major psychological theories (e.g., Transtheoretical Model,~     Prototype/Willingness Model) to identify moderators/mediators of outcome.~   "
217769|NCT00708799|"~     The purpose of this study is to determine whether macrolide treatment of patients with severe~     sepsis has an advantageous immunomodulatory and clinical effect compared to severe septic~     patients without macrolide therapy. Our main hypothesis is macrolide use in addition to~     standard therapy in severe septic patients has an advantageous immunomodulatory and clinical~     effect compared to patients with severe sepsis not treated with a macrolide.~   "
217732|NCT00709293|"~     The restoration of normal blood flow following a period of ischemia may result in ischemia /~     reperfusion injury (I/RI), which is characterized by inflammation and oxidative damage to~     tissues. Varying degrees of I/RI occur upon reperfusion of a donor heart after cold storage.~     Medications containing antibodies against immune cells have been used for many years as~     powerful immunosuppressants. These medications, called polyclonal antibody preparations, are~     generally only used immediately following transplantation and/or to treat rejection. At our~     institution, one such antibody preparation (Thymoglobulin) is used in most pediatric heart~     transplant recipients for 3-5 days immediately after transplantation. Because standard~     immunosuppressive medications (called calcineurin inhibitors) are toxic to the kidneys, the~     use of Thymoglobulin allows us to delay the initiation of calcineurin inhibitors until the~     kidneys of completely recovered from the shock of the transplant surgery.~      We hypothesize that Thymoglobulin may be beneficial in reducing the damage caused by I/RI.~     Thus, the present study seeks to evaluate the effectiveness of an intra-operative dose of~     Thymoglobulin (in addition to the standard doses post-operatively) at reducing the effects of~     I/RI. The study will be a double-bind placebo-controlled trial involving 20 subjects.~     Biologic markers for I/RI will be assessed at periodic intervals for six months~     post-transplantation. Subjects receiving intra-operative doses of Thymoglobulin will be~     compared to the controls in order to assess the effectiveness of intra-operative~     Thymoglobulin in ameliorating the effects of I/RI.~   "
217733|NCT00709280|"~     The purpose of this study is to assess whether 7% hypertonic saline (HS) is an effective and~     safe therapy in infants and young children with CF.~   "
217734|NCT00709267|"~     The purpose of the study is to determine the bioavailability of orally administered folic~     acid compared with the i.v. administered folic acid, and to use the samples collected to~     validate the analytical methods for estimation of folic acid in plasma and red blood cells~     (RBCs).~   "
217735|NCT00709254|"~     This study was designed to assess single-dose and multiple-dose PK and safety parameters~     utilizing a dosage of 3 mL (500 µg/mL)AeroLEF delivered via nebulization with the AeroEclipse~     BAN device. The study was conducted in opioid naïve subjects who were not blocked with~     naloxone or other opioid receptor antagonists.~   "
217736|NCT00709241|"~     This prospective observational study is designed to confirm the prognostic and economic~     impact of depression in ambulatory patients with systolic or diastolic heart failure, to~     explore the impact of other psychosocial patterns such as type D personality, anxiety~     disorders, locus of control, perceived social support, anger, hopelessness, and to evaluate~     potential pathophysiological and behavioral pathways.~   "
217737|NCT00709228|"~     To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral~     Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis~     C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the~     proportion of patients (%) with sustained virological response at 24 weeks post follow up~     treatment.~   "
217738|NCT00709215|"~     This is a two-part, open-label, Phase I/II study in subjects with relapsed or refractory~     TdT-positive leukemia for which no standard therapies are expected to result in durable~     remission.~   "
217739|NCT00709202|"~     The study attempts to evaluate a histamine analog long used for the treatment of Meniere's~     disease , betahistine, that,.shows promise in reversing the antihistaminergic effects thought~     to be involved in antipsychotic induced weight gain.~      The investigators hypotheses therefore are as follows:~        -  Youth who have gained a developmentally inappropriate amount of weight on SGAs will see~          their weight stabilize or even decrease with betahistine augmentation as compared to~          placebo augmentation.~        -  Betahistine augmentation in SGA treated youth will increase levels of satiety in a~          standardized meal situation and decrease caloric intake.as compared to placebo~          augmentation.~        -  Metabolic effects of betahistine augmentation in SGA treated youth will be reflected in~          a normalization of adipose distribution when compared to placebo augmentation, in~          particular with regards to the ratio of visceral to peripheral adipose tissue.~        -  Betahistine augmentation in this population will lead to a normalization in physiologic~          and lab values related to the development of metabolic syndrome as compared to placebo~          augmentation.~   "
217740|NCT00709189|"~     The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations~     of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The~     pharmacokinetics of blood folate from the formulation of 250 mcg NGM/35 mcg EE containing 400~     mcg folic acid and from 400 mcg folic acid administered alone is characterized.~   "
217741|NCT00709176|"~     The purpose of this study is to assess the quality of life of patients with advanced cancer~     and their family caregivers and to evaluate two doses of a family-based program of care~     versus control.~   "
217742|NCT00709163|"~     Nesiritide is a rapid vasodilator that mimics the action of an endogenous hormone - human~     B-type natriuretic peptide (BNP). BNP is produced naturally in the ventricles of the heart in~     response to stretch.~      Nesiritide decreases systemic vascular resistance (SVR), pulmonary capillary wedge pressure~     (PCWP), right atrial pressure (RAP), and mean pulmonary arterial pressure. Nesiritide does~     not affect the heart rate, but does increase the stroke volume and consequently cardiac~     output, resulting in a decrease in the symptoms of decompensated heart failure. It is~     generally well tolerated, with the major negative side effect being hypotension. When~     compared to standard therapy consisting of dobutamine and nitroglycerin, nesiritide had~     similar vasodilatory effects, but showed a lower incidence of arrhythmia.~      Nesiritide has been approved for IV treatment of patients with acutely decompensated~     congestive heart failure. Although studies have tested the effectiveness and safety of~     nesiritide in adult CHF patients, this has not been done in children.~      Subjects enrolled in this study will be pediatric (<21 years) patients carrying a diagnosis~     of dilated cardiomyopathy with decompensated congestive heart failure. The standard of care~     for these patients is to undergo cardiac catheterization with placement of a Swan-Ganz~     catheter for hemodynamic monitoring. Subjects will be randomly assigned to receive either~     Nesiritide or placebo (5% Dextrose). The infusion will then be continued for a total of~     twenty-four hours. During this one day period, measurements of systemic blood pressure,~     central venous pressure (right atrial pressure), pulmonary capillary wedge pressure, cardiac~     output, mixed venous saturation, pulmonary vascular resistance, and systemic vascular~     resistance will be measured at regularly scheduled intervals. The Swan-Ganz catheter will~     remain in place for 2 hours after the discontinuation of study drug, and then removed.~      The objectives of this study are:~        1. To assess the efficacy of Nesiritide therapy in decreasing the pulmonary capillary wedge~          pressure, right atrial pressure, and systemic vascular resistance in children with~          dilated cardiomyopathy.~        2. To assess the efficacy of Nesiritide in decreasing pulmonary edema and increasing~          cardiac index in the above mentioned population.~        3. To assess the safety of both bolus administration and continuous infusion of Nesiritide~          in children with dilated cardiomyopathy.~        4. To assess the pharmacokinetics of Nesiritide in this population.~   "
217743|NCT00709150|"~     This study will evaluate the effectiveness of culturally adapted depression treatment for~     reducing depressive symptoms and improving adherence to diabetes self-care regimens in~     Hispanics with depression and diabetes.~   "
217744|NCT00709137|"~     Joint National Committee 7 (JNC-7) defines resistant hypertension as a persistent elevation~     of blood pressure (BP) above goal - ≥ 140/90 mm Hg for the general hypertensive population or~     ≥ 130/80 mm Hg for persons with diabetes mellitus or chronic kidney disease - for at least~     three months despite treatment with three or more optimally dosed antihypertensive agents,~     including a diuretic. The exact prevalence of resistant hypertension is uncertain but may~     include 5-20% of hypertensive persons in primary care settings and 15-35% of the older,~     higher cardiovascular risk hypertensive patients incorporated into recent clinical trials of~     antihypertensive therapy. Observational studies demonstrate that patients with resistant~     hypertension experience a higher rate of cardiovascular and renal target organ damage such as~     left ventricular hypertrophy, microalbuminuria, and renal insufficiency and more~     cardiovascular disease (CVD) events than patients whose hypertension is well-controlled.~     Additionally, resistant hypertension patients may be subjected to the considerable expense of~     multiple office visits, diagnostic testing for secondary causes of hypertension, and referral~     to hypertension specialists. Because multiple factors can contribute to resistant~     hypertension, an explicit, sequential approach to evaluation and management is essential to~     optimize blood pressure, reduce cardiorenal morbidity and mortality, and avoid unnecessary~     expense. A number of observational studies have suggested the potential efficacy of both~     spironolactone and amiloride when added to a 3 drug antihypertensive regimen, but to date no~     randomized study has directly compared the two agents. The goal of this study is to determine~     whether spironolactone or amiloride is the more effective fourth agent to add to a three drug~     regimen in patients with resistant hypertension.~   "
217745|NCT00709124|"~     The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES)~     will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily~     NMES will improve strength and function in those who have had extended ICU stays, as well as~     decrease critical illness myopathy as an etiology of weakness in the critically ill.~   "
217746|NCT00709111|"~     Despite viral suppression, antiretroviral therapy (ART) does not restore CD4+ T-cell counts~     in some subjects. The purpose of this study is to assess whether adding maraviroc (MVC) to a~     suppressive ART will result in a significant CD4+ T-cell count increase over 24 weeks in~     subjects with suboptimal CD4+ T-cell recovery despite sustained virologic suppression.~   "
217747|NCT00709098|"~     Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial~     hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or~     currently being treated with a stable dose of either bosentan or sildenafil and who complete~     PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12~     week), randomized study to compare the safety and tolerability of inhaled iloprost power~     disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH).~     After completion of the double blind period, patients will be entered in the open label~     period using iloprost power disc-15.~   "
217748|NCT00709085|"~     The purpose of this study is to identify genetic determinants of susceptibility to liver~     cirrhosis and hepatocellular carcinoma. It will assist in predicting individual risks of~     disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis~     and hepatocellular carcinoma.~   "
217749|NCT00709072|"~     This study aims to determine the percentage and predictors of stuttering relapse following~     treatment with the Lidcombe Program. It will also investigate the effectiveness of sending~     reminder messages to parents to assist in reducing relapse.~   "
217750|NCT00709059|"~     The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol~     combination in treating patients with chronic hepatitis C in a primary care setting. Patients~     received no antiviral therapy prior to the current study. Only patients infected with~     Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will~     also explore the influence of liver fibrosis stage on the chances of achieving a sustained~     virologic response.~   "
217751|NCT00709046|"~     The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose~     of proton pump inhibitor after combined endoscopic hemostasis therapy.~   "
217752|NCT00709033|"~     Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma or~     chronic Lymphocytic Leukemia. Their lymphoma or CLL has come back or has not gone away after~     treatment. Because there is no standard treatment for the cancer at this time or because the~     currently used treatments do not work fully in all cases, patients are being asked to~     volunteer to take part in a gene transfer research study using special immune cells.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting disease:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including cells infected with~     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with~     cancers. They have shown promise, but have not been strong enough to cure most patients.~      The antibody used in this study is called anti-CD19. This antibody sticks to lymphoma cells~     because of a substance on the outside of these cells called CD19. CD19 antibodies have been~     used to treat people with lymphoma and CLL. For this study, the anti-CD19 antibody has been~     changed so that instead of floating free in the blood it is now attached to T cells. When an~     antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric~     receptor-T cells seem to be able to kill tumors, but they don't last very long and so their~     chances of fighting the cancer are limited.~      Investigators found that T cells work better if they also attach a protein called CD28 to the~     T cells. This protein makes the T cells more active and survive longer.~      Also they found that T cells that are also trained to recognize the virus that causes~     infectious mononucleosis (called Epstein Barr Virus or EBV) can stay in the blood stream for~     many years.~      These CD19-CD28 chimeric receptor T cells and CD19 chimeric-EBV specific T cells are~     investigational products not approved by the FDA.~      The purpose of this study is to find the biggest dose of chimeric T cells that is safe to~     administer, to see how long each of the T cell populations (CD19-CD28 and CD19-EBV-specific)~     last, to assess what the side effects are, and to evaluate whether this therapy might help~     people with lymphoma or CLL.~   "
217753|NCT00709020|"~     RATIONALE: White button mushroom extract may stop or delay the recurrence of breast cancer in~     postmenopausal breast cancer survivors.~      PURPOSE: This phase I trial is studying the side effects and best dose of white button~     mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who~     are breast cancer survivors.~   "
217754|NCT00709007|"~     Though the HIV epidemic in India is predominantly among heterosexual populations, it is~     estimated that there are approximately 1.1 million injection drug users (IDUs) in India with~     HIV prevalence as high as 64% among IDUs in certain cities. In April 2004, the government of~     India launched a free-antiretroviral therapy roll-out program aimed at initiating 100,000~     persons on HAART. Similar guidelines are currently being followed for the delivery and choice~     of HAART for IDU and non-IDU populations. However, IDUs have certain issues that complicate~     the delivery of HAART that need to be addressed by delivery programs such as delayed access~     to care, poor perceived adherence, and more rapid disease progression. This proposal will~     assess the feasibility and effectiveness of directly administered antiretroviral therapy~     (DAART) in conjunction with opioid substitution as a mode of delivery of HAART to IDUs in~     Chennai, India. To evaluate this objective we will conduct a randomized controlled pilot~     study of DAART vs self-administered therapy (SAT) among 100 HIV-1 infected treatment naïve~     IDUs who are enrolled in an opioid substitution program in Chennai and compare the following~     outcomes between the two arms: Primary Endpoint: Proportion of participants with viral load~     (VL) <400 copies/ml at 24 and 48 weeks; Secondary Endpoints: (1) Incidence of mortality and~     AIDS-defining illnesses at 24 and 48 weeks, (2) Changes in absolute CD4+ count from baseline~     at 24 and 48 weeks, and (3) Incidence of antiretroviral drug resistance at 24 and 48 weeks.~     Intention-to-treat analyses will be used. The study objective is in line with the priority~     areas identified in the Indian National AIDS Control Program Phase III (NACP III) and the~     results of this study will help inform the government of India on appropriate modes of~     delivery of HAART to IDUs. This study will also be among the first studies to be conducted in~     India to evaluate two different modes of delivery of HAART to IDUs.~   "
217758|NCT00708955|"~     This study will evaluate and provide standard treatments for people with various eye~     conditions. It will provide a resource for enrollment into new research protocols throughout~     the Eye Institute and will allow institute specialists the opportunity to maintain their~     expertise and gain additional knowledge of the course of various eye disorders. The~     information obtained will allow for the evaluation of standard treatments and may lead to~     ideas for future research.~      People with diagnosed or undiagnosed eye disease and first-degree relatives of people with a~     genetic or developmental eye disease may be eligible for this study. Participants are~     evaluated and treated in the National Eye Institute. Blood or other tissue samples (e.g.,~     urine, stool, hair, saliva or cheek swab) may be collected for future laboratory studies.~   "
217759|NCT00708942|"~     The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade~     cervical precancerous lesions (dysplasia) in women.~   "
217760|NCT00708929|"~     Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic~     component. Most importantly a genetic polymorphism in the gene encoding for the complement~     factor H (CFH) has been recently identified which is highly associated with an increased risk~     of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated~     to play a role in the development of the disease.~      Given that it is known that impaired regulation of choroidal vascular tone is present in~     patients with AMD, the current study seeks to investigate whether the Tyr402His polymorphism~     is associated with altered choroidal autoregulation in healthy subjects. For this purpose a~     total of 100 healthy volunteers will be included in order to test the hypothesis that an~     impaired regulation of choroidal blood flow is present in subjects with homozygous Tyr402His~     variant.~   "
217761|NCT00708916|"~     The purpose of this study is to determine the clinical and immunological effects of the~     phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous~     lupus erythematosus.~   "
217762|NCT00708903|"~     The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart~     (cardiac repolarization).~   "
217763|NCT00708890|"~     The Twelve Step groups are the most available and widespread self-help groups for patients~     with alcohol or drug related disorders. In a public health perspective, self-help groups~     (SHGs) may be considered as a supplement to professional treatment and provide aftercare soon~     as professional treatment has ended.~      There is a need to investigate if U.S. findings and procedures concerning referrals from the~     health services to Twelve Step Groups (TSGs) can be replicated and accommodated to a cultural~     setting which is unfamiliar with these groups. There is also a particular need in the~     Norwegian treatment system to develop alternative treatment strategies for patients~     undergoing detoxification to improve their chances of long-term recovery, due to deficient~     formal follow-up alternatives.~      We plan to carry out a RCT-study. One hundred and sixty patients entering a detoxification~     treatment center (Addiction Unit, Sørlandet Hospital, Kristiansand, Norway) will be assigned~     to two different groups: One given standard information about TSGs (brief advice) and one~     given intensive referral (motivational sessions and contact with TSG volunteers). A follow up~     assessment is planned at 6 months to determine whether intensive referral results in more TSG~     attendance, and if this mediates less substance use and better functioning outcomes.~      This study introduces a new concept in the Norwegian health care system and relies on a~     systematic cooperation with user organizations (SHGs) and user volunteers. Thus the study~     focuses strongly on user resources.~   "
217764|NCT00708877|"~     Today, available therapies for hilar cholangiocarcinomas (CCA) are not satisfactory. Although~     these tumors are rare, their study is important because of the high death rates in afflicted~     patients, rivaling that of pancreatic cancer. Surgical resection offers the only current hope~     for long-term survival, averaging only 20% in major series1. The reality is such that for the~     majority of patients, CCA is a diagnosis of despair.~      Although surgery has offered the only hope of cure, one of the major limiting factors in~     achieving long-term survival following surgical resection of CCA is the technical ability to~     achieve negative resection margins. The presence of malignant cells at the surgical margins~     following resection is a major prognostic factor predicting recurrence and death.~     Theoretically, the likelihood of achieving negative margins can be increased with total~     hepatectomy and orthotopic liver transplantation (OLT). Previous experience with OLT~     performed in isolation for hilar CCA's has been discouraging with dismal survival rates.~     However, a recent report has demonstrated that long-term survival can occur in carefully~     selected patients by combining the benefits of radiotherapy, chemosensitization, and OLT.~     With this strategy, patients survival rates of 92%, 82%, and 82% at 1, 3, and 5 years after~     transplantation have been achieved. It is not clear that these preliminary results can be~     confirmed at other centers, nor is it clear what selection criteria should optimally be used~     for this treatment strategy.~      Our hypothesis is that select patients undergoing liver transplantation for CCA in the~     context of multi-modality neoadjuvant therapy exhibit survival equivalent to other~     established indications for liver transplantation as previously demonstrated. We will also~     attempt to extend previously published criteria for liver transplantation in the setting of~     CCA by offering this protocol to patients with evidence of intrahepatic disease and regional~     nodal disease. Patients undergoing transplantation for CCA will be followed longitudinally~     for their entire post-transplant course and compared with a matched cohort of liver~     transplant recipients in regard to post-transplant survival, survival on the waiting list, as~     well as complications pre-and post-transplantation. Explanted livers will be examined for the~     presence of residual tumor.~      Data will be collected on the rate of regional lymph node metastasis, invasion of adjacent~     organs and tissues, and the rate of peritoneal metastases. The rate of tumor recurrence,~     site, and time to recurrence will also be assessed.~   "
217765|NCT00708851|"~     The purpose of this study is to determine if combining a daily at-home regimen using an LCD~     Solution with a 3 times weekly outpatient narrowband UVB phototherapy regimen could be a~     safe, effective, rapid, and, convenient treatment for plaque psoriasis.~   "
217766|NCT00708838|"~     The examination of the percentage of peripheral T cells carrying VLA-1 in ischemic heart~     disease patients. The hypothesis is that the percentage levels of cells carrying this~     integrin rise according to the severity of the ischemic heart disease.~   "
217767|NCT00708825|"~     Background: A conventional configured prosthetic arteriovenous graft (AVG) usually wastes~     most upper arm vessels that a reverse-loop design may conserve. This study examined the~     feasibility of the AVG construction and its outcome.~      Methods: Retrospective review of clinical outcomes of reverse-loop upper arm AVG patients.~     Measures included hemodialysis function, duplex scan, procedural complications, and follow-up~     interventions~   "
217768|NCT00708812|"~     In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between~     July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai~     Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital.~     All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy,~     patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus~     TC or TC alone for 3 cycles, 21 days as one cycle.~   "
232577|NCT00511914|"~     Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell~     culture, using the strain composition 2007/2008, when administered to adult and elderly~     subjects~   "
217770|NCT00708786|"~     The purpose of this study is to report the incidence of ventricular arrhythmias correlated to~     the SAS and to focus on the interest of diagnosing Sleep-disorders breathing in ICD patients.~     This diagnosis will be assessed by an ambulatory nasal pressure recording with portable~     multi-channel recorder associated to a complete SAS related symptoms questionnaire.This~     clinical trial will be the first step to gather information about the suspected sleep~     relation between ventricular arrhythmias and Sleep breathing disorders, in order to improve~     the management and treatment of such arrhythmias in next generation of defibrillators which~     will integrate a minute ventilation sensor able to monitor breathing.~   "
217771|NCT00708773|"~     Describe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan in~     cancer patients with advanced solid tumors with UGT1A1 6/6 and 6/7 genotypes.~   "
217772|NCT00708760|"~     We propose to develop and evaluate an interactive education software for administering~     moderate sedation by non-anesthesiologists.~   "
217773|NCT00708747|"~     Morbidity and mortality in patients suffering from systemic inflammatory response syndrome~     (SIRS) remain high. The primary aim of the present study is to assess the efficacy of a~     standardized 5% serum-protein solution containing immunoglobulins on serum cytokine levels.~     The secondary aim is to evaluate survival of the patients.~   "
217774|NCT00708734|"~     This is a one year pilot study evaluating the feasibility of a 10 week, twice weekly, group~     functional exercise sessions in individuals with knee osteoarthritis and its effect on gait~     and balance measures.~   "
217775|NCT00708721|"~     Study and Dose Rationale The safety profile of clofarabine appears acceptable within the~     target populations studied to date in the clinical studies summarized in Section 2.3.~     clofarabine has demonstrated anti-cancer activity through inhibition of DNA synthesis and~     repair, induction of apoptosis, and possibly through other mechanisms. The effect of~     clofarabine on DNA methylation has not been determined. Numerous responses have been observed~     after treatment with clofarabine in heavily pre-treated relapsed/refractory patients with ALL~     or AML.~      Recently 2 small studies were conducted at the M.D. Anderson Cancer Center looking at the use~     of clofarabine in the treatment of MDS.31 The first study randomized patients in a Bayesian~     fashion to 15 vs. 30 mg/m2 given IV daily for 5 days every 4 to 8 weeks. In the 15 mg/m2 arm~     3 of 7 patients had a complete remission according to the International Working Group (IWG)32~     criteria for response. In the 30 mg/m2 arm, 2 of 6 patients had a complete remission while 1~     patient had hematologic improvement according to IWG criteria. In the second study, patients~     were treated with oral clofarabine at a dose of 40 mg/m2 daily for 5 days every 4 to 8 weeks.~     Two of 7 patients had hematologic improvement according to IWG criteria. The main toxicities~     in both trials were prolonged myelosuppression and liver function abnormalities.~      Preclinical animal models have shown increased clofarabine activity against multiple~     different tumors with repetitive daily dosing for prolonged periods of time.33 The use of an~     oral therapy is advantageous for the treatment of a chronic malignancy such as MDS.~     Furthermore, based on the pre-clinical data mentioned above daily repetitive dosing over a~     protracted period may provide increased efficacy. Since most MDS patients are elderly and may~     not tolerate aggressive therapy, a schedule of administration of low dose oral clofarabine~     over a protracted period may provide the advantage of increased efficacy without severe~     toxicity. The safety of a protracted daily dosage of oral clofarabine in humans has not been~     determined. The dosing scheme for this study will therefore include a dose escalating phase I~     component followed by a phase II component. The starting dose will be 5 mg (fixed dose)~     orally daily for 10 days. This dose will be escalated in cohorts of 3 patients as tolerated~     up to a maximal dose of 15 mg (fixed dose) orally for 10 consecutive days. Note that at the~     latter dose a patient will receive a total of 150 mg of clofarabine per cycle, which far~     lower than the MD Anderson study of oral clofarabine in MDS whereby patients received 200~     mg/m2 per cycle.~      OBJECTIVES:~      Study Overview The purpose of this study is to determine the efficacy and toxicity of~     Clofarabine administered orally at a low daily dose for the treatment of myelodysplastic~     syndromes.~   "
217776|NCT00708708|"~     This prospective observational cohort study will assess the average duration of the drug free~     interval between etanercept treatment cycles in usual care settings in Germany.~   "
217777|NCT00708695|"~     This study is a longitudinal follow-up of 670 primarily African-American women and their~     17-year-old firstborn children enrolled since 1990 in a highly significant randomized~     controlled trial (RCT) of prenatal and infancy home visiting by nurses. Nurses in this~     program are charged with improving pregnancy outcomes, child health and development, and~     maternal economic self-sufficiency. This follow-up examines whether earlier program effects~     on maternal and child functioning lead to less violent antisocial behavior, psychopathology,~     substance use and use-disorders, and risk for HIV; whether these effects are greater for~     those at both genetic and environmental risk; and whether program effects replicate those~     found with whites in an earlier trial.~   "
217778|NCT00708682|"~     The purpose of this study will be to evaluate safety, tolerability and immunogenicity of~     13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations~     in Mexico.~   "
217779|NCT00708669|"~     To evaluate the procedural, short and long term clinical outcomes of the TAXUS stent compared~     to Cypher stent in coronary arteries of ≥ 2.5 and ≤ 3.75 mm in the reference vessel diameter~     with a lesion of ≤ 46 mm (by visual observation) in routine clinical settings in Japan.~   "
217780|NCT00708656|"~     The purpose of this study is to compare the safety and effectiveness of dosing mesalazine 800~     mg tablets (Asacol®) at 2.4 g once daily versus divided doses three times daily in the~     maintenance of remission of ulcerative colitis.~   "
217781|NCT00708643|"~     This study seeks to evaluate the clinical and subjective performance of a new daily~     disposable soft contact lens.~   "
217782|NCT00708630|"~     This study aims to investigate the effect of providing additional information about possible~     mild side effects of the yellow fever vaccination on the reporting of physical symptoms.~     Additionally, the project aims to investigate the relationship between individual~     characteristics (trait anxiety and perceived sensitivity to medication) and the reporting of~     physical symptoms, as well as possible interactions between the level of information provided~     and individual characteristics. We hypothesize that more information about mild symptoms~     provided to participants will increase the number of reported symptoms after vaccination.~   "
217783|NCT00708617|"~     Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C.~     However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry)~     are already used in current practice. The aim of this study is to validate the diagnostic~     value of FIBROSCAN by comparison with liver histology. FIBROSCAN will be also compared to~     Fibrotest and FIBROSCAN-Fibrotest association to each test alone in order to optimize this~     diagnostic strategy.~      Studied variables will be significant fibrosis (≥ 2 in the METAVIR score) and presence of~     cirrhosis (score : F4). Diagnostic values of the scores will be expressed by sensitivity,~     specificity, positive and negative predictive values, and ROC curves. Areas under ROC curve~     of the scores will be compared using Z test.~   "
217798|NCT00708422|"~     The purpose of this randomized, double-masked, parallel-group, multicenter study is to~     evaluate ocular surface effects after the administration of travoprost with SofZia®~     preservative system or Xalatan once daily for 12 weeks.~   "
217784|NCT00708604|"~     The purpose of this study is to determine the safety of islet transplantation in patients~     with type 1 diabetes who have had a successful kidney transplant and have been maintained for~     at least three months on anti-rejection medications consisting of any combination of~     sirolimus, tacrolimus, MMF or prednisone (5 mg/day or less). Another purpose is to determine~     the effectiveness of an islet transplant in inducing insulin independence and whether or not~     an islet transplant improves quality of life for kidney transplants patients with type 1~     diabetes.~   "
217785|NCT00708591|"~     To determine the maximum tolerated dose, observed toxicities, and dose limiting toxicities,~     and antitumor response of rapamycin plus ketoconazole in patients with advanced cancers.~   "
217786|NCT00708578|"~     Primary objective:~      To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin~     glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level~      Secondary objective:~      To compare the incidence of hypoglycemia in each treatment group~   "
217787|NCT00708565|"~     The objective of this study is to determine if single dose administration of inhaled iloprost~     will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve~     arterial oxygenation at rest and during exercise at high altitude.~   "
217788|NCT00708552|"~     The study is designed to investigate the efficacy, safety and tolerability of SB-742457~     versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an~     experimental treatment which increases the levels of certain chemicals in the brain that are~     often decreased in patients with Alzheimer's disease.~   "
217789|NCT00708539|"~     To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone~     in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient~     convenience.~   "
217790|NCT00708526|"~     The proposed study will measure the time from the end of surgery until the time patients meet~     the discharge criteria from the postoperative anesthesia care unit and the time from the end~     of surgery until the patients regained cognitive function after anesthesia.~   "
217791|NCT00708513|"~     The purpose of this study is to demonstrate the safety and benefit of auto-transfusion~     filtered blood in patients undergoing major surgical oncology procedures.~   "
217792|NCT00708500|"~     This study involves treatment with boceprevir or placebo in combination with pegylated~     interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) in adult~     subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness~     (a decrease in hepatitis C virus RNA [HCV-RNA] viral load >=2 log10 by Week 12 or~     undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic~     response (SVR) on prior treatment with any combination therapy of peginterferon alpha and~     RBV. This trial includes three arms, one control arm (PEG2b + RBV for 48 weeks) and two~     experimental arms (PEG2b + RBV + boceprevir). One of the experimental arms, Arm 3, consists~     of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm,~     Arm 2, consists of all three drugs for 32 weeks after the lead-in. Participants in Arm 2 who~     were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point.~     Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12~     weeks of PEG2b + RBV + boceprevir placebo. It is hypothesized that the addition of a third~     active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and~     therefore, the addition of boceprevir to PEG2b plus RBV therapy after a 4-week lead-in period~     may allow for both increased rates of SVR and shorter treatment durations (in some~     populations) than treatment with peginterferon plus RBV alone.~   "
217793|NCT00708487|"~     The potentially damaging effect of free O2 radicals to cultured embryos may be reduced by~     adding scavengers to the culture media or by reducing the incubator O2 levels. However,~     lowering the O2 in the culture environment can be expensive, troublesome and may not be~     justifiable. The objective of this study is to evaluate the effect of lowered incubator O2~     tension on live birth rates in a predominately day-5 embryo transfer program. The hypothesis~     of this study is that a lowered (more physiological)oxygen concentration in embryo culture~     incubators will increase live birth rates for in vitro fertilization patients. 230~     first-cycle women undergoing routine IVF or ICSI with ejaculated sperm will be randomized in~     a prospective clinical trial and stratified for patient age and physician. Embryos of~     patients will be randomly assigned for culture in either a 21% O2 (atmospheric) or 5% O2~     (reduced) environment. Clinical endpoints monitored will be rates of implantation, clinical~     pregnancy, live birth and blastocyst cryopreservation.~   "
217794|NCT00708474|"~     This study compares the fill of bone graft sites in the knee. It is hypothesized that harvest~     sites, voids, and defects caused by trauma that are treated with the OsseoFit™ Porous Tissue~     Matrix™ device will achieve a better fill grade than those treated with the conventional~     method.~   "
217795|NCT00708461|"~     The primary aim of this research is to evaluate the efficacy of a multicomponent~     worksite-based, environmental intervention in reducing weight increase and obesity over time~     in working adults.~   "
217796|NCT00708448|"~     This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments~     using positron emission tomography (PET) imaging in 21 patients with Stage IIIB/IV or~     recurrent non-small cell lung cancer (NSCLC) and an early post therapy assessment at baseline~     and at various early time points (2 weeks in 7 patients, 4 weeks in 7 patients, and 6 weeks~     in 7 patients) after institution of erlotinib (anti-EGFR) (Tarceva) and bevacizumab~     (anti-VEGF) (Avastin) for first-line treatment of Stage IIIB/IV or recurrent non-squamous~     NSCLC. The proposed PET imaging and blood derived biomarkers trial is a companion study to an~     approved therapeutic trial (IRB# 24377). The therapeutic trial of erlotinib (Tarceva) and~     bevacizumab (Avastin) for first-line treatment of Stage IIIB/IV or recurrent lung cancer with~     drug costs exceeding $150,000 per patient/year (study drug budget exceeds $5 million) was~     funded for study at the HCI and the HICCP, statewide trial network. The proposed imaging~     study has been funded by the University of Utah Synergy Grant Program. The clinical imaging~     biomarkers will include an assessment of tumor metabolism [Banrasch 1986, Frauwirth 2002,~     Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977,~     Warburg 1956, Weber 1977A, Weber] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields~     2001,Shields 1998, Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow and~     perfusion( H215O-PET)[Lodge 2000]; and tumor blood volume of distribution ( H215O -PET)[Lodge~     2000] in the same patient at baseline and then in the same patient at one of the post therapy~     time points (2 weeks, 4 weeks, or 6 weeks). The investigators hypothesize that by using a set~     of imaging derived biomarkers and biomarkers from blood they can predict response, either~     prior to or at an earlier time point than would normally be determined with standard imaging~     techniques, in patients with lung cancer receiving combined bevacizumab and erlotinib.~   "
217797|NCT00708435|"~     The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N~     (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by~     coumarin derivatives in subjects who require immediate correction of INR (International~     Normalized Ratio)and to stop an acute major bleeding.~   "
217799|NCT00708409|"~     With the current knowledge of aortic valve replacement modalities, no specific~     recommendations can be given and the decision for a particular prosthesis or procedure is~     rather arbitrarily. The investigators hypothesize that the autograft procedure according to~     Ross is superior in terms of hemodynamic (especially regression of left ventricular~     hypertrophy) and major adverse valve related events even in a long-term course~   "
217800|NCT00708396|"~     The purpose of the study is to evaluate tolerability and efficacy of escitalopram (Cipralex)~     treatment in doses beyond 20mg (20-40 mg/d) in patients with OCD and schizophrenia, non~     responsive or partially responsive to recommended doses (evaluation according to Y-BOCS).~      An open label, prospective study. The study will include 20 patients recruited from the~     inpatient wards and from the outpatient clinic who have a DSM-IV diagnosis of schizophrenia~     or schizoaffective disorder and OCD.~      Before entering the study all patients will be interviewed by 2 senior board certified~     psychiatrists in order to confirm the diagnosis of schizophrenia or schizoaffective disorder~     and OCD according to DSM-IV criteria.~      After confirming the diagnosis of schizophrenia/schizoaffective disorder and OCD each patient~     will be evaluated by PANSS, Y-BOCS and GCI-S scales. Those patients who score above 12 points~     on the Y-BOCS will be eligible for the study.~      Rating scales (PANSS, Y-BOCS, CGI-S, CGI-I) will be completed on a weekly basis during the~     whole 13 weeks period. In addition patients will be asked to report medication side effects~     and will also be clinically evaluated for side effects by the physician. Special attention~     will be paid to worsening of psychosis or OC symptoms. All patients whose mental status will~     deteriorate or those who cannot tolerate the drug will be dropped-out and intent to treat~     analysis will be made.~   "
217801|NCT00708383|"~     Human conception in vivo occurs in a complex milieu that includes proteins. It has been~     speculated that the addition of proteins more complex than human serum albumin to culture~     media may improve IVF outcomes. Whether the expense, labor and risk of adding additional~     human-derived protein to IVF media are warranted is a question unanswered. Patients,~     undergoing routine IVF or ICSI, will be assigned to one of two treatment groups in a~     randomized, prospective clinical trial . Embryos will be cultured in either media~     supplemented with human serum albumin (HSA) as a solitary protein supplement or in media~     supplemented with HSA + SSS from the 2-PN stage until the time of embryo transfer. Clinical~     endpoints monitored will be implantation rate, clinical pregnancy rate and live birth rate.~     It is expected that the supplementation of commercial embryo culture media containing HSA~     with the more complex protein source, SSS, will result in an overall increase in~     implantation, clinical pregnancy, and live birth rates. In the balance, protein enrichment of~     media may represent opportunities to simultaneously increase the live birth rate and reduce~     the incidence of multiple gestations.~   "
217802|NCT00708370|"~     This study is a local PCO sponsored, interventional, non-drug study to evaluate the efficacy~     of a health tele-counselling program in reducing cardiovascular risk in dyslipidemic~     patients.~   "
217803|NCT00708357|"~     Nitric oxide (NO) is a potent endothelium-derived vasodilatator that plays a major role in~     the control of ocular blood flow. Endothelial NO synthase (eNOS) is one of three isoforms of~     NOS producing NO through hydroxylation of L-arginine. The eNOS gene is located on the long~     arm of chromosome 7, and different polymorphic variations have been identified. These single~     nucleotide polymorphisms (sNP´s) have the ability to change transcription activity and~     therefore enzyme levels. Recent data indicate that the T -786C polymorphism (especially the~     homozygous variant) is associated with reduced eNOS activity and consequently impaired NO~     production.~      In the present study the investigators want to investigate if the T -786C eNOS gene~     polymorphism determines choroidal and optic nerve head blood flow.~   "
217804|NCT00708344|"~     To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide~     (HCTZ) using either a usual or an active elective titration regimen. The main efficacy~     criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's~     office with an automatic device, after a 10-week treatment period in hypertensive patients~     insufficiently controlled by monotherapy.~   "
217805|NCT00708331|"~     The purpose of this study is to evaluate the safety and efficacy of Hydrophilic Acrylic~     Intraocular Lens after cataract surgery~   "
217806|NCT00708318|"~     This was a pilot, phase I, two-period, fasting, bioavailability, safety,and pharmacokinetic~     study evaluating single dose of i.v. fentanyl (200 µg) and single doses of 2 mL or 3 mL~     inhaled AeroLEF (500 µg/mL) delivered by nebulization with the AeroEclipse BAN device~     administered in normal healthy non-smoking subjects.~   "
217807|NCT00708305|"~     The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF)~     containing toothpastes in prevention of dental caries. Change from baseline fluoride data at~     various time points up to four hours after a single brushing with NaF containing toothpastes~     will be evaluated.~   "
217808|NCT00708292|"~     This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously~     in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part~     will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the~     study includes a Phase Ib combination part of AUY922 administered in combination with~     bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with~     multiple myeloma.~   "
217809|NCT00708279|"~     The purpose of this study is to assess the effectiveness of osteopathic manipulation in~     decreasing angina pectoris symptoms.~   "
217848|NCT00707772|"~     Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The~     surveillance data from Ministry Of Health in IR.Iran had shown that 60% of them are infected~     with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV.~   "
217849|NCT00707759|"~     The present study investigates the safety and efficacy of steroid withdrawal at six days~     post-transplant in pediatric renal recipients under concomitant immunosuppression based on~     antibodies anti IL2 (interleukin 2), Tacrolimus (TAC) and Mycophenolate Mofetil (MMF). To~     investigate the impact of this protocol in growth, bone metabolism, insulin- sensitivity and~     evaluate the expression of IL17 (interleukin 17) and mRNA FOXP3 (messenger ribonucleic acid~     forkhead box protein 3) as early markers of acute rejection (blood, urine and renal biopsy).~      Hypothesis:Steroid withdrawal in renal pediatric transplant patients improves growth and bone~     metabolism without increasing the risk of acute rejection. The expression of FoxP3/IL17 in~     urine cells could be an early molecular markers of acute rejection.~   "
217810|NCT00708266|"~     This is a mono-center randomized controlled trial to be performed in the Center of Medical~     Research (ZMF) at Medical University Graz and is composed by one screening visit (V1) and two~     study visits (V2 and V3). In the visit V1, complete medical examination will be performed and~     blood samples will be withdrawn to check overall conditions of the healthy volunteers. Those~     who accomplish the necessary conditions will be enrolled in the trial to receive either~     saline or lipid-heparin solutions in a randomized, cross-over design during visits V2 and V3.~     Volunteers will arrive at ZMF after overnight fasting, when two venous catheters will be~     placed in forearm veins. One venous catheter will be used for continuous infusion of~     lipid-heparin solution (Intralipid 20%, 40 ml/h, Fresenius Kabi plus Heparin 250U/h, IMMUNO~     Baxter AG) or saline, and Inulin (Inutest 25%, Fresenius Kabi). The second venous catheter~     will be used for blood sampling (arterialized venous blood). Subsequently, two open flow~     microperfusion (OFM) macro-perforated catheters will be inserted in the subcutaneous tissue~     of abdominal wall for continuous sampling of interstitial fluid. Study visits will last for~     28 hours for continuous sampling, with four additional hours for observation after infusion~     discontinuation, during visits V2 and V3. Concentrations of different cytokines,~     non-esterified fatty-acids, insulin, glucose, triglycerides and inulin will be~     retrospectively quantified in the frozen samples.~      The primary hypothesis is that cytokine concentrations in subcutaneous tissue and/or in~     circulation can be modified by lipid-heparin infusion.~   "
217811|NCT00708253|"~     Background: The small bowel has been a black box for gastrointestinal (GI) endoscopy as,~     until recently, most of the small bowel was not accessible with conventional endoscopes.~     Double-balloon enteroscopy (DBE) is an endoscopic procedure for visualizing the entire small~     bowel. The method was first described by Yamamoto and colleagues in 2001. Both endoscopic~     diagnosis and treatment can be easily performed using DBE. The first larger series, recently~     published, demonstrate that DBE is feasible in visualizing large parts of the small bowel.~     Although DBE has widely been used routinely for examining the small intestine there are a few~     issues which may limit its use. The preparation and handling of the DBE-endoscope is often~     interpreted as being complex (such as attaching the balloon to the tip of the endoscope,~     inflating/deflating the two balloon systems).~      Recently, a novel balloon enteroscope system has been developed using only a single balloon~     (single balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and treatment of~     the small bowel. The endoscopist needs to manipulate only one single balloon; thereby, time~     and complexity for preparation of the system and for the examination itself may be reduced.~     However, the new SBE system may be less efficient for deep intubation of the small bowel and~     may cause adverse effects due to the hooking of the endoscope during straightening of the~     endoscope.~      Study Aim: The primary aim of the present study is to compare the new SBE system with the~     standard DBE system with respect to completeness of visualisation and insertion depth of the~     small bowel, as well as complications during the procedure.~   "
217812|NCT00708240|"~     Although research suggests that patients with obsessive-compulsive disorder (OCD) exhibit~     specific deficits in their high cognitive processes, it is still unknown how these deficits~     relate to the clinical symptoms of the disorder, and to the response to treatment. There are~     two aims for the proposed research. The first is to examine how high cognitive processes and~     brain activity are affected in OCD. The second aim is to investigate the effects of a~     specific psychotropic medication (escitalopram) on high cognitive processes and brain~     activity in OCD. We will investigate how 40 youth with OCD (recruited in specialized clinics)~     differ from 40 healthy youth (recruited from the local community) on selected cognitive tests~     and brain imaging paradigms, as well as explore how treatment with medication can correct or~     reverse the observed differences. The final goal of our research is to learn more about the~     mechanisms of action for available treatments, in order to refine and improve short- and~     long-term therapeutic strategies for a highly debilitating and often lifelong disorder.~   "
217813|NCT00708227|"~     This study will help to find out if having a certain genetic makeup influences how a person~     with asthma responds to salmeterol, one of the two drugs in Advair(R).~   "
217814|NCT00708214|"~     Progression-free rate after 16 weeks of BIBW 2992 administration in association with~     letrozole~   "
217815|NCT00708201|"~     This study is being conducted to determine whether alvimopan can accelerate recovery of~     gastrointestinal function following radical cystectomy when compared with a placebo.~     Secondary objectives of the study are:~        -  to evaluate the effect of alvimopan on hospital length of stay~        -  to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related~          morbidities~        -  to evaluate the overall and cardiovascular safety of alvimopan~   "
217816|NCT00708188|"~     This is a prospective study including acute ischemic stroke patients aged 18 to 90.~     Multidetector raw CT is performed in acute ischemic stroke patients. Heart, neck vessels and~     brain arteries are studied during the same acquisition. Results are compared with the~     standard methods including transesophageal echocardiography (TEE), Doppler ultrasound (DUS)~     and MR angiography (MRA) of neck vessels. The main criteria is the ability of CT to classify~     the stroke etiology correctly according to the TOAST classification in comparison with the~     standard methods.~   "
217817|NCT00708175|"~     The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in~     postmenopausal women with impaired fasting glucose.~   "
217818|NCT00708162|"~     The purpose of this study is to compare the safety, tolerability and efficacy of a regimen~     containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a~     background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or~     2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults~     who have documented resistance, or at least six months experience prior to screening with two~     or more different classes of ARV agents.~      Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen~     (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to~     known drug interactions, participants in the Elvitegravir group receiving RTV-boosted~     atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will~     receive elvitegravir at a lower dose (85 mg).~   "
217819|NCT00708149|"~     The purpose of this study is to determine whether lansoprazole administered nasogastrically~     is effective for stress ulcer prophylaxis in respiratory intensive care unit.~   "
217820|NCT00708136|"~     The proposed project is a Randomized Controlled study design. Seniors (age >65) willing to~     participate in the study will be shortly interviewed to assess eligibility according to the~     inclusion-exclusion criteria. The first 60 subjects who upon questioning were judged to meet~     the following inclusion criteria:~        1. able to stand independently 90 seconds~        2. able to walk 10 meters (with cane if necessary)~        3. able to understand verbal instructions.~      The exclusion criteria will be:~        1. Serious visual impairment~        2. Inability to ambulate independently (cane acceptable, walker not).~        3. Severely impaired cognitive status (score less then 24 in Mini Mental State~          Examination).~        4. Persons with impaired communication capabilities.~      The whole project will be conducted over a period of 24 months. The proposed study is a~     randomized experimental intervention/ control group design. A total of 60 elderly volunteer~     subjects will be randomly assigned to two groups, exercise group (30) and control group (30).~     Twelve training periods will be performed with 8 subjects participating in training during~     each period (4 exercise groups). The exercise group will meet on 24 occasions over a period~     of 12 weeks (2 times/week).~      Gait and balance function will be tested in both groups with well established measuring~     techniques before and after the training period. The measuring techniques~        1. Medical background variables.~        2. Berg Balance Scale.~        3. Late life Function and Disability Instrument.~        4. Get up and go test - stand up and walk 3 meters turn around and walk back to the chair.~        5. Fall Efficacy Scale~        6. Fall incidence and fall severity.~        7. 6-minute walk test. The control group will not perform any specific balance training~          during the 12 week period.~      These individuals from control will participate in a separate exercise program after the~     training period.~      The water training intervention is performed on different levels where each level reflects~     different increasing demands on the postural control system. The water exercises also include~     perturbation exercises that trigger specific reflex-like balance responses. On each level the~     instructor can instantly modify an exercise to be more or less challenging for each~     participant.~   "
217821|NCT00708123|"~     This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries~     lesions in an in situ model.~   "
217822|NCT00708110|"~     GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV~     infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging,~     placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect,~     safety, tolerability, and pharmacokinetics of GSK1349572 monotherapy versus placebo over 10~     days in ART-naïve and experienced, but integrase inhibitor naïve (meaning never having had an~     integrase inhibitor) HIV-1 infected adults who are not currently receiving antiretroviral~     therapy. This study consists of a screening visit, a treatment period and a follow-up~     evaluation. Thirty subjects will be randomized to receive one of three doses of GSK1349572 or~     placebo q24h over 10 days. Antiviral effect measures include viral load and CD4 cell count.~   "
217823|NCT00708097|"~     This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries~     lesions in an in situ model~   "
217824|NCT00708084|"~     The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in~     combination with rabies vaccine compared with human rabies immune globulin (HRIG) in~     combination with rabies vaccine in healthy children and adolescents.~   "
217825|NCT00708071|"~     The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant~     with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to~     reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).~   "
217826|NCT00708058|"~     This is a study to determine the feasibility of obtaining information stored in existing~     Medtronic internal defibrillators in patients who present to the Emergency Department(ED) for~     any reason. In addition, the study will determine if this information is useful to the ED~     physician in managing the patient's care, specifically as it relates to heart failure.~   "
217827|NCT00708045|"~     Patients must have had their breast cancer treated at the Huntsman Cancer Institute to be~     eligible for this trial.~      OBJECTIVES:~      To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to~     better understand the cognitive disorder known as chemobrain which effects up to 16 -50% of~     individuals receiving long-term adjuvant chemotherapy [Tannock 2004, Matsuda 2005]. The study~     is exploratory to obtain proof of feasibility pilot data to support an eventual submission to~     the NIH.~      Neuropsychological Testing A battery of testing will be used to assess the subjective~     complaints of cognitive impairment in the symptomatic patient cohort. Similarly the same~     battery of tests will be used to assure that the non-symptomatic patient control group and~     the age-matched normal controls do not exhibit any cognitive impairment. The following set of~     clinical tests will be performed to assess the degree of cognitive impairment in all~     subjects.~   "
217828|NCT00708032|"~     This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens~     on the neophyte population.~   "
217829|NCT00708019|"~     This study will test two different doses of a psychoeducational intervention to improve~     cancer pain management. In addition, the study will determine if the changes in pain~     management behaviors that the patients and family caregivers learn continue to be used when~     the intervention stops. It is hypothesized that patients and family caregivers who receive~     the high dose intervention will have a greater decrease in pain intensity scores.~   "
217830|NCT00708006|"~     The purpose of this study is to evaluate the safety and tolerability of HGS1029 in subjects~     with advanced solid tumors and to determine a phase 2 dose.~   "
217831|NCT00707993|"~     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily~     (QD), compared to glipizide in elderly diabetic patients who have not received treatment or~     are on a single oral medication.~   "
217832|NCT00707980|"~     The purpose of this study is to determine the long-term efficacy and safety of vortioxetine,~     once daily (QD), in adults with major depressive disorder.~   "
217833|NCT00707967|"~     This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB~     vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.~   "
217834|NCT00707954|"~     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of~     TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period~     and then 14 consecutive days). Dose escalation design is utilized in this study, and dose~     escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step~     2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of~     the previous step.~   "
217850|NCT00707746|"~     The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in~     the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and~     apolipoprotein B (apoB) in high risk subjects intolerant to statins.~   "
217851|NCT00707720|"~     The Barosense Trans-oral Endoscopic Restrictive Implant System (TERIS) is an investigational~     system being evaluated for safety The system uses endoscopic guidance to trans-orally implant~     a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to~     induce early and prolonged satiety. The Intended Use of the system is for the treatment of~     obesity.~   "
217835|NCT00707941|"~     Background In preparation for a global influenza pandemic, there is an urgent need for~     representative data from populations and settings where the pandemic is most likely to arise.~     There are no data on oseltamivir efficacy from Asian urban slum populations concerning~     duration of illness and viral shedding, nor whether efficacy depends on starting treatment <~     48 hours or ≥ 48 hours after illness onset. Finally, there are no data on the capacity of the~     drug, in such settings, to affect household and community transmission rates.~      Aims and Objectives This proposal aims to compare the duration of clinical illness among~     patients treated with oseltamivir vs placebo < 48 hours and ≥ 48 hours after illness onset.~     It will compare the duration of viral shedding among all treatment groups vs placebo, risk of~     transmission to household contacts by treatment group and whether neuraminidase inhibitor use~     creates resistance. Secondarily it aims to measure the effect on influenza.~      Design and Methods A double-blind placebo controlled clinical trial design among a population~     in an urban slum under current influenza disease burden surveillance will be enrolled.~     Infection status will be confirmed by rRT-PCR. Patients ≥ 1 year old will be randomised to <~     48 hour and ≥ 48 hour treatment arms. Family members and neighbours will also be assessed by~     PCR and a basic reproductive number calculated (R0).~      Relevance These findings will address whether oseltamivir can affect illness duration and~     severity, affect transmission, incidence and resistance in high risk urban Asian settings~     where a pandemic is most likely to arise.~   "
217836|NCT00707928|"~     Primary objective The primary objective of this study is to see whether intravenous (IV) NTG~     100-200 microgram can effectively help extract retained placenta as compared to placebo, in a~     randomized controlled multicenter study.~      Secondary objective is to compare the hypotensive effects of NTG as compared to placebo,~     including others side effects such as headache, blood loss, or others.~   "
217837|NCT00707915|"~     Benzodiazepines (BZDs) have been reported to cause negative impacts on motor as well as~     cognitive functions, which in turn could result in lethal incidents including falls~     especially in the elderly. This notwithstanding, few trials have evaluated a feasibility and~     benefits of discontinuing BZD-derivative hypnotics in a systematic manner in this frail~     population. In this 8-week open-label study, we examined changes in motor and cognitive~     functions following the discontinuation of BZD hypnotics in older persons.~      OBJECTIVES & HYPOTHESES~        1. Primary Objective The primary objective is to examine the feasibility of discontinuing~          BZD-derivative hypnotics in older people.~        2. Secondary Objectives~             1. One of the secondary objectives is to examine the magnitude of discontinuing~               BZD-derivative hypnotics in the stability of body.~             2. Another secondary objective is to examine the magnitude of discontinuing~               BZD-derivative hypnotics in cognitive function.~      Hypotheses~      1. More than 80% of the participants will complete and tolerate all the study procedures.~      2a. Participants will show an improvement in the stability of body. 2b. Participants will~     show an improvement in the cognitive function globally as well as specifically in attention.~   "
217838|NCT00707902|"~     The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a~     chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of~     treatment.~      Main outcome parameter is the non-inferiority in number of responders between the two~     treatment groups. A responder is defined as a reduction by 50% of the total baseline score~     taken prior to treatment start. The symptoms are assessed with a symptom score.~   "
217839|NCT00707889|"~     To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on~     disease progression in advanced colorectal cancer.~   "
217840|NCT00707876|"~     The purpose of this study is to compare the difference between two magnetic resonance imaging~     (MRI) techniques for visualizing arteries. The study hypothesizes that one method that relies~     upon imaging flowing blood in the pelvic and leg arteries will not be as accurate or~     efficient as injecting a safe imaging agent to change the appearance of the blood on the MRI.~     Both methods will be compared with Digital Subtraction Angiography (DSA).~   "
217841|NCT00707863|"~     The purpose of this study is to find out what parts of the brain have increased or decreased~     activity when people are depressed and how antidepressant medicine changes this activity in~     depressed patients. The genetic samples collected are to look at variation in a gene~     (serotonin transporter gene), which affects the functioning of the chemical serotonin in the~     brain~   "
217842|NCT00707850|"~     Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis~     and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk~     for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon~     alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.~   "
217843|NCT00707837|"~     An evaluation of a preterm infant formula containing ingredients similar to those found in~     breastmilk~   "
217844|NCT00707824|"~     Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in~     patient undergoing cesarean section?~   "
217845|NCT00707811|"~     Trouble breathing (dyspnea) is a nonspecific symptom associated with many diseases such as~     chronic obstructive pulmonary disease (lung disorder in which the flow of air to the lungs is~     blocked), asthma, pneumonia, pulmonary hypertension (high blood pressure in the lungs),~     congestive heart failure (fluid build-up in the lungs because the heart is not pumping~     normally) and pulmonary embolism (blood clot in the lungs). The purpose of this study is to~     test two blood markers called ST2 and IL-33. Blood markers are proteins or other compounds in~     your blood that physicians use to diagnose different diseases and to determine what the~     course of an illness will be. In preliminary research studies, ST2 and IL-33 have been~     elevated in patients with a wide variety of diseases where the lungs are the primary organs~     involved. This research study will further investigate the ability of ST2 and IL-33 to~     predict the severity of disease and the possible use of ST2 and IL-33 in the diagnosis of~     various lung diseases.~   "
217846|NCT00707798|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of~     pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of~     two months.~   "
217847|NCT00707785|"~     The purpose of the study is to determine whether vitamin A can improve survival and~     facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.~   "
232722|NCT00510029|"~     The study will assess the safety, tolerability and pharmacokinetics of single intravenous~     (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour~     infusion.~   "
217852|NCT00707707|"~     This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination~     with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative~     breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study~     to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to~     be used in the randomized Phase II part. The safety and tolerability of AZD2281 in~     combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5~     countries will be enrolled in Phase I.~   "
217853|NCT00707694|"~     We believe extreme longevity is due to specific genes which function to delay aging and~     prevent disease. The purpose of our research is to identify the genes/mutations associated~     with healthier aging; to understand the biological functions of these genes/mutations; and to~     develop therapies to replicate these preservative genetic activities in individuals who do~     not have the genetic profile for longevity.~   "
217854|NCT00707681|"~     To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients~     using European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30~     questionnaire.~   "
217855|NCT00707668|"~     This is an observational study on the prevalence and incidence of diabetes and osteoporosis~     in a rural area of Korea.~   "
217856|NCT00707655|"~     The purpose of this study is to investigate the safety of zalutumumab in combination with~     radiotherapy as the treatment of patients with head and neck cancer who are not eligible for~     platinum based chemotherapy.~   "
217857|NCT00707642|"~     The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in~     healthy adults.~   "
217858|NCT00707629|"~     To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years~     diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3~     years) compared to a group of children matched for age, sex, glycemic control, and diabetes~     duration treated with insulin injections. Outcome measures will assess: clinical variables,~     cognitive status (intelligence, neuropsychological functioning), academic achievement,~     behavior, parenting stress, and quality of life.~      It is hypothesized that long term insulin pump therapy initiated during early childhood can~     delay the progression of neurocognitive complications of diabetes, decrease parental stress,~     and improve school performance and quality of life, as compared to insulin injections.~   "
217859|NCT00707616|"~     Type 2 diabetes is a common metabolic disorder arising from a complex interaction between~     genetic predisposition and the environment. The development of this disorder is preceded by~     impaired glucose tolerance and elevated fasting glucose which also carry adverse~     cardiovascular risk. To date a few common genetic variants have been reliably associated with~     predisposition to type 2 diabetes. However, it is uncertain how these genes interact to alter~     insulin secretion and insulin action prior to the development of type 2 diabetes. We propose~     to utilize an established population-based cohort to determine how common genetic variants~     associated with type 2 diabetes alter the response to an oral glucose challenge in people~     without overt type 2 diabetes. This will enable us to understand how common variants alone or~     in combination alter whole-body glucose physiology and predispose to type 2 diabetes.~   "
217860|NCT00707603|"~     Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with~     >200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity~     and heart disease are extremely common. This study will examine the relationship between~     insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to~     CHC~   "
217861|NCT00707590|"~     To assess the safety and tolerability and the PK/PD relationship of BMS-767778 administered~     as single and multiple oral doses in healthy subjects, and in subjects with T2DM~   "
217862|NCT00707577|"~     This research study is being done: 1) to determine if the MGH Be Fit program helps employees~     to change their nutrition and exercise habits and lower their risk for chronic diseases, such~     as heart disease and diabetes and 2) to determine if a maintenance program following the Be~     Fit 12 week program will help employees to keep the positive health changes.~   "
217863|NCT00707564|"~     The purpose of this study is to determine if the HemCon Dental Dressing is effective in~     stopping bleeding during dental surgeries in patients taking anticoagulant medications.~   "
217864|NCT00707551|"~     The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is~     handled by the body, i.e the absorption, distribution, metabolism and excretion, when~     administered in combination with AZD1305.~   "
217865|NCT00707538|"~     The purpose of this clinical research study is to learn the biodistribution of injection of~     BMS747158 at stress and assess the safety of two doses of BMS747158~   "
217866|NCT00707525|"~     There is a considerable concern about the effects of controlled ovarian hyperstimulation~     (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the~     incidence of chromosomal abnormalities in oocytes and embryos.~      The main question remaining is if COH may increase the aneuploidies rate in young and healthy~     women. Therefore, the primary endpoint of the present study is to analyse the incidence of~     chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes~     obtained after a natural cycle or in those retrieved after a COH cycle. To get rid of the~     male factor influence, donated sperm will be used.~   "
217867|NCT00707512|"~     The primary objective of the study is to determine the incidence and pattern of serious~     and/or clinically significant infections, malignancies, and other serious adverse event (SAE)~     in participants with Crohn's Disease (CD) treated with natalizumab. The secondary objective~     of this study in this study population is to evaluate disease severity over time in~     participants with CD treated with natalizumab based on changes in the Harvey-Bradshaw Index~     (HBI).~   "
217868|NCT00707499|"~     The purpose of this clinical research study is to learn the safety and biodistribution of~     BMS747158 in normal, healthy volunteers.~   "
217869|NCT00707486|"~     The purpose of this study is to determine if the HemCon Dental Dressing is effective in~     stopping bleeding during dental surgeries.~   "
217870|NCT00707473|"~     The goal of this clinical research study is to learn if docetaxel, 5-fluorouracil, and either~     cisplatin or carboplatin in combination, then followed by chemoradiotherapy is effective in~     controlling cancers of the paranasal sinuses.~   "
232975|NCT00506701|"~     Tadalafil may lower the pulmonary artery pressure in patients with Chronic Obstructive Lung~     Disease and secondary pulmonary hypertension and thereby improve patients quality of life.~   "
217871|NCT00707460|"~     The purpose of this study is to evaluate whether or not a traditional First Nations diet~     (high protein) and/or a dietary intervention based upon current Canadian dietary~     recommendations (high carbohydrate/high fiber) effects risk factors for type 2 diabetes~     mellitus and/or cardiovascular disease in a remote fly in First Nations community (Sandy Lake~     First Nation).~      This pilot has been developed in conjunction with Sandy Lake First Nation to answer the~     research question: Will a traditional diet or a diet based upon current Canadian dietary~     recommendations result in decreasing risk for type 2 diabetes in Sandy Lake?~   "
217872|NCT00707447|"~     A type 2 diabetes prevention programme, named PREDIAS was developed. It consists of 12~     lessons delivered as group sessions. Die efficacy of PREDIAS was studied in a randomized~     controlled study with 12 month follow up. Control group received written information about~     diabetes risk. Primary outcome variable was weight reduction at 12 months follow up.~     Secondary variables were impact of the intervention on glycemic parameters, lipids, eating~     and exercise behavior and other metabolic risk factors~   "
217873|NCT00707434|"~     The goal of this clinical research study is to learn if The Guardian® blood-sugar monitoring~     device can be used reliably in patients with high blood sugar who are receiving care in the~     ICU. Researchers will compare blood-sugar measurements from the study device with blood-sugar~     measurements from the standard fingerstick method of blood-sugar testing. This is being~     done to see if the new device can accurately measure blood sugar.~   "
217874|NCT00707421|"~     Antiglaucoma medication have been shown to induce subclinical conjunctival inflammation in a~     considerable proportion of glaucoma patients. Today, trabeculectomy still remains the gold~     standard as surgical treatment of medically uncontrolled glaucoma disease. However, this~     procedure is associated with variable possible complications, of which subconjunctival~     fibrosis is the most frequent one. The latter results in a non-functional filtering bleb. As~     a consequence, either additional interventions such as laser suture lysis, needling, bleb~     revision or additional IOP-lowering medication is necessary. Previous studies demonstrated a~     benefit of the use of topical steroids postoperatively in reducing inflammation and~     subsequent subconjunctival fibrosis. In this perspective, we will prospectively explore the~     usefulness of topical NSAID or corticosteroid therapy preoperatively as compared to placebo~     in subjects scheduled for first-time trabeculectomy, without interrupting topical~     antiglaucoma therapy. This will allow us to determine wether the impact of longterm topical~     antiglaucoma therapy on subclinical conjunctival inflammation which possibly result in~     postoperative fibrosis and bleb failure can be reversed by anti-inflammatory medication~     before filtering surgery.~   "
217875|NCT00707408|"~     This is a multicenter open-label phase II trial of high dose imatinib mesylate in patients~     with AML in first or second relapse, or with refractory disease. Daily dosing of imatinib 600~     mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day~     imatinib is permitted for 2 additional months in the event of response failure. Response is~     assessed after 1, 2 and 3 months of treatment by bone marrow aspirate.~   "
217876|NCT00707382|"~     The purpose of this study is to determine whether genotyping for CYP2D6 and 2C19~     polymorphisms or intense clinical monitoring of treatment and adverse effects improves the~     antipsychotic treatment in patients with schizophrenia. This study is designed as a~     three-armed prospective randomized controlled clinical trial and includes 300 patients with~     schizophrenia. Patients are followed for a period of one year.~      During the study period the following effect measures are registered:~        -  Time to discontinuation of all antipsychotic medications~        -  Number of changes in medication dose~        -  Number of changes in medication~        -  Compliance (patients´ adherence to medical treatment)~        -  Clinical symptoms~        -  Adverse effects~   "
217877|NCT00707369|"~     The purpose of this study is to determine the size of the benefit of an adjunctive empiric~     antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions~     in a representative sample of German periodontitis patients.~   "
217878|NCT00707356|"~     The aim of this clinical study is to determine the optimal treatment conditions to achieve~     prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in~     patients with localized prostate cancer.~      The secondary objectives is to evaluate safety and quality of life ; to assess the~     pharmacokinetic parameters and to model the relationship between concentration and effects;~     and to assess the effects, the safety and quality of life of a second WST11 VTP treatment in~     patients with persistent or recurrent localized prostate cancer after a first VTP;~   "
217879|NCT00707343|"~     Despite significant advances in the understanding of brain tumor biology and genetics as well~     as improvements in surgical techniques, radiotherapy administration, and chemotherapy~     methods, many primary brain tumors remain incurable. Most primary brain tumors are highly~     infiltrative neoplasms, and are therefore unlikely to be cured by local treatments such as~     surgery, focal radiotherapy, radiosurgery or brachytherapy. A particularly problematic aspect~     of the management of patients with brain tumors is the eventual development of enhancing~     lesions on MRI after radiation therapy. The treating physician is then left with the dilemma~     of what this enhancing lesion may represent (radiation necrosis versus recurrent tumor). The~     differential diagnosis is between recurrent tumor or radiation necrosis however the amount of~     each contributing to the enhancing mass on MRI is difficult if not impossible to assess. This~     particular problem is very common and most patients develop some degree of radiation necrosis~     after therapy with radiation. Differentiation of necrosis from recurrence is particularly~     challenging. MRI is typically unable to make this important distinction as there is simply an~     enhancing mass, the etiology of which could be either necrosis or recurrence. Other imaging~     methods such as FDG-PET have been used but this technique is also complicated in that the~     normal brain has FDG uptake and it is often difficult to differentiate recurrence from~     necrosis. [F-18]FLT may prove to be the most reliable method in making this important~     differentiation (necrosis versus recurrence) as normal brain and necrotic brain do not have~     proliferative activity and thus no [F-18]FLT uptake whereas tumor will have proliferative~     activity and thus [F-18]FLT uptake.~   "
217880|NCT00707330|"~     The purpose of the study is to examine whether Klacid® (Clarithromycin) will induce oxidative~     stress (stress from oxygen) in healthy subjects. This is done by measuring the content of a~     particular substance in the urine sample, which is released when the body is exposed to~     oxidative stress. In addition, there will also be taken blood samples, which is analysed for~     another substance that is indicative of oxidative stress.~   "
217881|NCT00707317|"~     Until recently, the tuberculin skin test (TST) was the only available diagnostic assay for~     detection of latent infection with M. tuberculosis (LTBI). Despite the low overall incidence~     of symptomatic tuberculosis infection in low-prevalence countries, the potential mortality~     and morbidity mandate constant vigilance to identify patients at risk for reactivation. Due~     to systemic immunosuppression, immunocompromised patients with latent M. tuberculosis~     infection are at increased risk of progression to active disease. This applies to patients~     with various causes of immunodeficiency such as HIV-infected patients, allogeneic stem cell~     and solid organ transplant recipients, patients with rheumatoid arthritis and patients with~     chronic renal failure. Therefore, current guidelines aimed at preventing tuberculosis~     infection in immunocompromized individuals recommend a generalized screening for evidence of~     latent infection to target appropriate preventative prophylaxis. At present, tuberculosis~     control programs exclusively rely on the tuberculin skin test to identify a latent infection~     in asymptomatic individuals.~      Recently, novel in vitro assays termed T cell interferon-gamma release assay (TIGRA) have~     become available that are based on the detection of interferon-gamma (IFN-gamma) production~     in T cells or supernatants after stimulation with highly specific antigens of M.~     tuberculosis. Two TIGRA are commercially available, the ELISPOT based T.SPOT.TB and the ELISA~     based QuantiFERON-TB Gold test (now available as an IN-TUBE version).~      The aim of the study is a prospective comparison of the two commercially available approved~     TIGRA (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) with the established Mendel-Mantoux~     skin-test in immunocompromized patients (main focus on sensitivity and specificity).~      The study hypotheses are as follows:~        1. In immunocompromised patients, the two commercially available approved TIGRA~          (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) have increased sensitivity and specificity~          as compared to the established Mendel-Mantoux skin-test.~        2. Results from QuantiFERON-TB Gold In-Tube and T.SPOT.TB do not differ in~          immunocompromised patients.~   "
217882|NCT00707304|"~     The purpose of this study is to determine whether talactoferrin can improve overall survival~     in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two~     or more regimens.~   "
217883|NCT00707291|"~     The goal of this study is to look at contact lens on the eye and its interaction with the eye~     during wearing.~   "
217884|NCT00707278|"~     The study is a prospective phase I trial of radiation therapy concurrent with capecitabine~     and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma.~     Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the~     pancreas that is surgically unresectable. Patients will undergo radiation therapy (28~     treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin~     chemotherapy. The primary objective of the study is to determine the maximum tolerated doses~     of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy~     with or without surgery in this patient population.~      Secondary objectives of the study are to determine the tumor response rate, survival rate,~     local control rate and the rate of distant metastases following capecitabine, oxaliplatin,~     and radiation therapy with or without surgery and to determine the rate at which patients~     with unresectable disease become resectable.~   "
217885|NCT00707265|"~     The purpose of this study was to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System as a~     method of facilitating spinal fusion in patients with degenerative disc disease.~   "
217886|NCT00707252|"~     The purpose of this study is to study if the addition of the green tea extract, Polyphenon E,~     to Erlotinib is safe and if it has potential to improve outcomes in second line therapy for~     Advanced Stage IIIb/IV Non-small cell lung cancer.~   "
217887|NCT00707239|"~     This study will compare the safety and efficacy of a tigecycline regimen versus an~     imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with~     hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have~     ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and~     compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a~     minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of the~     investigator based on the subject's condition. Additional protocol specified antibiotics may~     be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will~     be done 10 to 21 days after the last day of therapy. The total duration of subject~     participation will be between 17 and 44 days, including a follow up period of 30 days after~     the last day of therapy for SAEs.~      Subjects will be followed for safety and efficacy. The safety assessment will include:~     physical examinations, vital signs, assessment of the clinical signs and symptoms of~     pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology,~     serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before study~     entry for women of childbearing potential. The clinical and microbiological efficacy will~     both be evaluated.~   "
217888|NCT00707226|"~     After focusing many years only on intraocular pressure (IOP) as the primary risk factor,~     recently the impact of ocular blood flow is getting more consideration for the~     pathophysiology of glaucoma. The circadian change of intraocular pressure (IOP) is well~     investigated, but diurnal variations in ocular blood flow are yet to be evaluated, especially~     in glaucomatous eyes.~      This study is performed to investigate circadian variation of ocular blood flow assessed by~     laser interferometric fundus pulsation amplitude (FPA) and laser Doppler flowmetry (LDF) in~     glaucomatous eyes during topical antiglaucoma therapy at 8:00, 12:00, 17:00 and 21:00, to~     compare these circadian variation of ocular blood flow in glaucomatous eyes with variations~     in healthy eyes and to relate blood flow variations with IOP variations.~   "
217889|NCT00707213|"~     Patients must be currently treated at the Huntsman Cancer Institute or Intermountain Primary~     Children's Medical Center to be eligible for this study.~      Although there have been many advances in the assessment and treatment of infections~     responsible for febrile neutropenia in cancer patients, it still remains a common~     complication of cancer therapy and accounts for the majority of chemotherapy-associated~     deaths. This National Cancer Institute (NCI) funded proposal using the R-21 Quick-Trials~     Exploratory Grant mechanism is to conduct an exploratory/pilot project in a group of patients~     with persistent febrile neutropenia to provide critical information that will support the~     concept, and aid in the design, of a larger multi-center clinical trial. The ultimate goal of~     our interdisciplinary team of oncologists, infectious diseases experts, imagers, and~     biostatisticians is to conduct a prospective, multi-center trial to establish the utility and~     cost-effectiveness of PET/CT using the widely available glucose analogue~     [18F]fluoro-2-deoxy-D-glucose (FDG) in identifying sites of infection in cancer patients with~     persistent febrile neutropenia without an obvious identifiable source thus improving targeted~     therapy.~   "
217890|NCT00707200|"~     The purpose of this study is to determine the importance of key blood group molecules in the~     clinical outcome of Plasmodium falciparum malaria infection in children.~   "
217891|NCT00707187|"~     Purpose of the study is to evaluate the effectiveness and safety of a new investigational~     dur, IC351. Study is designed to gather information regarding the possible usefulness of~     IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud~     phenomenon as well as the vaginal dryness and discomfort associated with scleroderma~   "
217892|NCT00707174|"~     This study is designed as a randomized, prospective study to test the efficacy of imiquimod~     plus tazarotene in the treatment of LM. Eligible and consented patients will be randomized to~     one of two treatment groups: 1) topical imiquimod group, or 2) topical imiquimod combined~     with topical tazarotene group. All patients will undergo a staged surgical excision with rush~     permanent sections to confirm negative histologic margins. This will be followed by a~     surgical repair of the defect and long-term follow-up of five years to rule out recurrences.~     Both groups will have a polygonal excision using 2mm margins per stage.~   "
217893|NCT00707161|"~     The study is a prospective phase II trial of radiation therapy concurrent with cisplatin~     chemotherapy in the treatment of locally advanced or metastatic melanoma in patients who are~     deemed to require radiation therapy by treating physicians for purposes of local control or~     palliation. Eligibility criteria include pathologically confirmed melanoma. Patients will~     undergo radiation therapy (20 treatments of 2.5 Gy for a total of 50 Gy) concurrent with~     cisplatin chemotherapy.~   "
217894|NCT00707148|"~     The purpose of this study is to look at the safety and immunogenicity of a combination~     vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis~     (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of~     the newborn infant and the effect of the mother's vaccination on the infants' immune~     responses prior to vaccinating infants with another combination vaccine to protect against~     diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old.~     Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy~     complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo,~     inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood~     samples will be collected from the mother and infant, along with the baby's growth~     measurements. Participation for mother infant pairs is about 15 months and about 7 months for~     non-pregnant women.~   "
217895|NCT00707135|"~     The goal of this study is to determine the rapamycin dose equivalent to the recommended phase~     II/III dose of temsirolimus and determine the observed toxicities and anti-tumor response of~     rapamycin in patients with advanced cancers.~   "
217896|NCT00707122|"~     BACKGROUND The association between mortality and hypoalbuminemia has been observed in several~     diseases. Nonetheless, the efficacy of albumin on survival in critically ill patients is~     controversial. Several meta-analyses have reported either negative, neutral, or beneficial~     effects of albumin administration. To clarify this controversy, a large multicenter~     prospective study has been performed, comparing the effects of 4% albumin vs. saline for~     volume replacement in critically ill patients. Although no difference in the overall~     mortality has been observed, a predefined subgroup analysis has shown a trend of longer~     survival in septic patients treated with albumin. As fluid replacement has been shown to be~     critical in sepsis, and based on both its primary (oncotic) and secondary properties~     (anti-inflammatory), it is conceivable that the use of albumin for volume replacement and for~     treating hypoalbuminemia may have a beneficial effects on survival of septic patients.~      OBJECTIVES Primary objective: to verify whether volume replacement with albumin (treated~     group) and its maintenance within plasmatic physiologic range (equal or above 30 g/l)~     improves survival of patients with severe sepsis of septic shock, as compared to crystalloids~     (control group). Secondary objectives: to verify the differences in organ dysfunctions,~     hospital and intensive care unit (ICU) length of stay between the treated and control group.~      METHODS About 1350 patients with severe sepsis or septic shock will be randomized to receive~     either albumin or crystalloids as fluid therapy. Volume replacement will be performed for~     both groups according to the early-goal directed therapy. Treated group will receive 60 gr~     albumin infusion after randomization, and 40-60 gr albumin daily infusion to maintain serum~     album level equal or above 30 g/l. Control group will receive crystalloids for the entire~     study; albumin administration will be allowed only when daily serum albumin level will be~     lower than 15 g/l. Patients will be treated until the 28th day after randomization or until~     ICU discharge, whichever comes first.~      EXPECTED RESULTS Primary outcomes: absolute risk reduction of overall mortality of 7.5% at~     28th day, with a further control at 90th day, following randomization. Secondary outcomes:~     reduction of number and severity of organ dysfunctions (as assessed by the Sequential Organ~     Failure Assessment score), reduction of ICU and hospital length of stay.~   "
217897|NCT00707083|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.~      PURPOSE: This randomized clinical trial is studying the side effects of two combination~     chemotherapy regimens and to see how well they work in treating children with newly diagnosed~     acute lymphoblastic leukemia.~   "
217898|NCT00707070|"~     It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy~     and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis.~     PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24~     will be the secondary end points. Safety measures will be the monitoring of serum parameters~     including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.~   "
217899|NCT00707057|"~     The purpose of this study is to evaluate the efficacy and safety of multiple doses of~     Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of~     third molar teeth.~   "
217900|NCT00707044|"~     Objective: To evaluate the safety and cost-effectiveness of Short Stay Intensive Care (SSIC)~     treatment for low-risk coronary artery bypass patients Design: Randomized clinical~     equivalence trial Setting: University Hospital Maastricht, the Netherlands Patients: low-risk~     coronary artery bypass patients Interventions: 600 patients were randomly assigned to undergo~     either SSIC treatment (8 hours Intensive Care) or control treatment (care as usual, overnight~     Intensive Care).~      Measurements: The primary outcome measures were Intensive Care (IC) readmissions and total~     hospital stay. The secondary outcome measures were total hospital costs, Quality of Life~     (QoL), postoperative morbidity and mortality. Hospital costs consisted of the cost of~     hospital admission(s) and outpatient costs.~   "
217901|NCT00707031|"~     The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in~     comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24~     weeks of treatment, followed by an extension.~      The primary objective is to assess the effects of lixisenatide in comparison to exenatide~     (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated~     hemoglobin (HbA1c) reduction (absolute change) at Week 24.~      The secondary objectives are to assess the effects of lixisenatide on percentage of patients~     reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (<=) 6.5%, fasting~     plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact~     of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper~     gastrointestinal disorders - quality of life [PAGI-QOL]).~   "
217902|NCT00707018|"~     Comparison of immobilization in internal versus external rotation after first time anterior~     shoulder dislocation.~   "
217903|NCT00707005|"~     The purpose of this study is to determine the in vitro antibiotic susceptibility patterns of~     conjunctival bacterial flora isolated preoperatively from patients undergoing refractive~     surgery.~   "
217904|NCT00706992|"~     Background:~        -  Melanoma antigen recognized by T cells (MART-1) is a gene that is present in melanoma~          cells.~        -  This study tests an experimental treatment that uses the patient's own lymphocytes (type~          of white blood cell), which are specially selected and genetically modified with a gene~          called anti-MART-1 transduced cells (F5) to target and destroy their tumor. Some of the~          cells are given as an infusion and others are given as a vaccine.~        -  The anti-MART-1 F5 cells are currently being studied in other patients in combination~          with chemotherapy and IL-2 (aldesleukin) therapy.~      Objectives:~      -To determine if the anti-MART-1 F5 treatment can improve the immune system's ability to~     shrink tumors and to prevent melanoma from recurring.~      Eligibility:~        -  Patients 18 years of age and older whose melanoma has been removed and are currently~          disease-free, but who are at risk for recurrence.~        -  Patients who do not have ocular or mucosal melanoma.~        -  Patients with tissue type human leukocyte antigens (HLA-A)*0201).~      Design:~        -  Workup: Patients have scans, x-rays, laboratory tests, other tests as needed and~          leukapheresis, a procedure for collecting white cells to modify in the laboratory and~          later reinfuse into the patient.~        -  Patients are assigned to one of four study groups:~             -  Group 1 receives anti-MART-1 F5 cells by 30-minute infusion through a vein on day~               0.~             -  Group 2 receives anti-MART-1 F5 cells on day 0 followed by injections of MART-1~               vaccine, which contains MART-1 and an oil-based liquid called Montanide ISA-51 VG.~               The vaccine is repeated on day 30.~             -  Group 3 receives anti-MART-1 F5 cells on day 0 followed by injections of low-dose~               IL-2 for 5 days (days 0-4).~             -  Group 4 receives anti-MART-1 F5 cells on day 0 followed by MART-1 vaccine and~               low-dose IL-2 for 5 days. The vaccine is repeated on day 30.~        -  Recovery: Patients are monitored closely and given medicines to prevent or treat any~          side effects of therapy.~        -  Leukapheresis: Patients undergo leukapheresis at 1 and 3 months after therapy to collect~          cells to examine the effects of the treatment on the immune system.~        -  Follow-up: Patients return to National Institutes of Health (NIH) 35 days after~          completing treatment and then at 3 months and every 6 months thereafter for evaluation~          with a physical examination, review of side effects, laboratory tests and scans. They~          have blood tests at 3, 6 and 12 months after treatment and then once a year after that.~          A biopsy may be requested after treatment ends to examine the effects of treatment on~          the immune system. All patients return to NIH for a physical examination once a year for~          5 years and then complete a follow-up questionnaire for another 10 years.~   "
217905|NCT00706979|"~     A sample of smokers who have no current plans to quit will be recruited for this study and~     randomized to one of two intervention conditions:~        1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or~        2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT).~      This study will test whether adding free nicotine replacement therapy to brief advice to~     undertake a practice quit attempt will motivate more smokers to make a serious attempt to~     stop smoking than brief advice without NRT. All treatments and assessments will be delivered~     via telephone and mailing. The primary outcome of interest is the incidence of a serious~     attempt to permanently stop smoking made over a six-month study period.~      Our specific hypotheses are as follows:~      Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a~     higher incidence of making a serious effort to quit smoking permanently, compared to an aided~     practice quit attempt without NRT. We also expect provision of NRT will increase point~     prevalence abstinence at 6 month follow-up.~      Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors~     will be mediated by a) increased smoking related self efficacy, b) increased belief in the~     efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support~     for not smoking, and e) less withdrawal distress and craving during the practice quit~     attempt.~   "
217906|NCT00706966|"~     RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging,~     may help in learning how well dutasteride works in patients with benign prostatic hypertrophy~     and low-risk prostate cancer.~      PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in~     patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.~   "
217907|NCT00706953|"~     The purpose of this study is to evaluate the safety and effectiveness of using pegylated~     liposomal doxorubicin and bortezomib in the treatment of patients with relapsed multiple~     myeloma who had been previously treated with bortezomib. Multiple myeloma is a cancer that~     begins in plasma cells, a type of white blood cell. These cells are part of the immune~     system, which helps protect the body from germs and other harmful substances. In time,~     myeloma cells collect in the bone marrow and in the solid parts of bone. Multiple myeloma~     treatment may include stem cell transplantation, however, not all patients with multiple~     myeloma are candidates for stem cell transplantation and many patients who receive~     transplants relapse. As a result, additional first and later-line therapeutic options are~     needed for patients who are not candidates for transplantation, or whose disease relapses~     after transplantation or other therapies. Pegylated liposomal doxorubicin in combination with~     bortezomib is approved for the treatment of patients with multiple myeloma who have not~     previously received bortezomib and have received at least one prior therapy. The combined use~     of pegylated liposomal doxorubicin and bortezomib in this study is designed to evaluate the~     overall response rate and safety in patients with multiple myeloma who have been previously~     treated with bortezomib.~   "
217908|NCT00706940|"~     Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months~     and during 6-month follow-up after discontinuation of study treatment.~   "
217909|NCT00706927|"~     Glaucoma is one of the most common causes of blindness in the industrialized nations. For a~     long time glaucoma has been defined as a disease in which high intraocular pressure (IOP)~     leads to irreversible optic disc damage and subsequent visual field loss. However, recent~     investigations show that IOP is not the only factor that is involved in the glaucomatous~     process leading to retinal ganglion cell death. The role of vascular factors in the~     pathogenesis of glaucoma has recently received much attention based on animal experiments and~     epidemiological studies. The main focus of glaucoma is still directed towards a decrease in~     IOP. There is, however, also considerable interest whether antiglaucoma drugs influence~     ocular perfusion. Although measurement of ocular blood flow is still difficult, a number of~     innovative techniques have been realized which cover different aspects of ocular perfusion.~     In the present study Xalacom® (latanoprost/timolol) and the fixed combination of Combigan®~     (brimonidine/timolol) will be compared with respect to their IOP lowering efficacy as well as~     their ocular hemodynamic effects.~   "
217910|NCT00706914|"~     This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of~     aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the~     evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs.~     formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in~     patients with moderate to severe COPD.~   "
217959|NCT00706251|"~     For patients with chronic epiphora, Dacryocystorhinostomy is currently the gold standard~     treatment, with a success rate of 80-90% according to literature. Another available~     treatment, which is far less used, in nasolacrimal intubation, using a silicone tube.~      In our study, we would like to find the efficacy of nasolacrimal duct intubation, which was~     performed in our medical center on a few hundred patients with mild epiphora.~      Study hypothesis: nasolacrimal intubation in adults, with a clinically mild epiphora, is~     close in it's efficacy to the Dacryocystorhinostomy procedure.~   "
217911|NCT00706901|"~     Two approaches for providing evidence-based substance abuse treatment (EBT), group~     motivational interviewing (GMI) and the In-Home-Messaging-Device (IHMD), are interventions~     that have the characteristic ability for increasing accessibility to evidence-based treatment~     among patients with substance use problems and are proposed for investigation. GMI is based~     on motivational interviewing, an intervention that has shown consistent significant effects~     in promoting treatment retention and reduced substance use among individuals with substance~     use disorders, and is delivered in a group format. IHMD is a user-friendly computerized~     Tele-mental Health communication tool that allows interaction through the telephone line~     between a Veteran and the health care provider in an individual's home or residential~     placement. The current proposal aims to determine whether GMI and IHMD lead to a~     significantly greater increase in treatment engagement and reduction in alcohol use compared~     to a treatment control condition (TCC) among Veterans with a substance use problem and a~     co-existing psychiatric disorder.~   "
217912|NCT00706888|"~     We put forward that polyphenols and vitamins have a cardiovascular prevention effect for~     subject with cardiovascular risk.~   "
217913|NCT00706875|"~     The purpose of this study is to collect information on the effects of treatment for~     gestational trophoblastic disease (GTD). We plan to use the findings from this study to~     better understand GTD survivors' health and quality of life.~      We would like to know more about the health, quality of life and pregnancies of women treated~     for GTD. This information will be used to try and improve the treatments for women who have~     this disease.~   "
217914|NCT00706862|"~     The purpose of the study is to determine whether the combination of talactoferrin,~     carboplatin and paclitaxel improves progression free survival and overall survival in~     patients with non-small cell lung cancer compared to the combination of paclitaxel and~     carboplatin alone~   "
217915|NCT00706849|"~     The purpose of this study is to determine whether mipomersen safely and effectively lowers~     low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial~     Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable~     dose of other lipid-lowering agents (including maximally tolerated statin therapy).~   "
217916|NCT00706836|"~     The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy~     controls to examine the acute effects of certain anxiolytic medications on brain function. In~     this case, the medication pregabalin will be used. The investigators hypothesize that~     pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala~     and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.~   "
217917|NCT00706823|"~     The purpose of this study is to evaluate a new disposable supra-glottic airway device, the~     i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of~     insertion, position within the airway, drain tube patency and anatomic sealing properties~     during mechanical ventilation in non-obese anesthetized patients undergoing elective general~     surgery. The study device will be compared to the current standard in the industry, the LMA~     Unique.~   "
217918|NCT00706810|"~     Meningiomas account for 20% of primary adult brain tumors, occurring at an annual incidence~     of 6 per 100,000 (Louis, Scheithauer et al. 2000). Complete surgical resection is the~     treatment of choice but may not possible when the tumor invades critical structures (e.g.,~     skull base, sagittal sinus) (Mirimanoff, Dosoretz et al. 1985; al-Rodhan and Laws 1990;~     Al-Rodhan and Laws 1991; Newman 1994; De Monte 1995; Levine, Buchanan et al. 1999; Barnett,~     Suh et al. 2000; Ragel and Jensen 2003). Up to 20% of meningiomas exhibit a more aggressive~     phenotype that does not respond to standard therapies (Kyritsis 1996). Adjuvant therapies are~     critical for patients with this subset of meningiomas. Radiation therapy and stereotactic~     radiosurgery are good adjuvant therapies but are limited by radiation neurotoxicity, tumor~     size constraints, and injury to adjacent vascular structures or cranial nerves (Goldsmith,~     Wara et al. 1994; Barnett, Suh et al. 2000; Goldsmith and Larson 2000). Standard~     chemotherapeutic treatments have been disappointing (Kyritsis 1996). Even drugs like~     temozolomide that have shown efficacy against malignant brain tumors have failed to inhibit~     the growth of refractory meningiomas in a phase II study (Chamberlain, Tsao-Wei et al. 2004).~   "
217919|NCT00706797|"~     To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN)~     + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in~     subjects with moderate RA who were treated with MTX monotherapy, but continue to have~     moderate disease activity.~   "
217920|NCT00706784|"~     This research study is looking at how well a new drug delivery system, called the vaginal~     ring, works to get hormones into your body as a form of birth control.~   "
217921|NCT00706771|"~     The investigators will determine the feasibility, safety and efficacy of intravenous sodium~     bicarbonate in reducing progression to overt acute renal failure in patients with the~     systemic inflammatory response syndrome, and low urine output or early acute renal impairment~     as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).~   "
217922|NCT00706758|"~     In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan~     to compare the effects of a structured patient group education (IBS school) with receiving~     only written information in the form of a IBS-guidebook. The effects of the interventions on~     GI and psychological symptom severity, knowledge and quality of life will be assessed with~     validated questionnaires at baseline and 3 and 6 months after the intervention.~   "
217944|NCT00706446|"~     This study is looking at the effects of certain long-acting bronchodilators on patients with~     asthma who have specific genetic variations. The investigators are interested in a certain~     common genetic variation in the receptor for beta-agonists, which is found in as many of~     one-sixth of the population. There is evidence that patients with asthma who have this~     variation may not do as well when treated with albuterol on a regular basis. The~     investigators will be looking at whether patients with this variation have more asthma~     exacerbations over the course of a year when treated with salmeterol or formoterol, which are~     long-acting forms of albuterol; and whether these patients have fewer exacerbations when~     treated with tiotropium, which is a different long-acting bronchodilator that does not act at~     this receptor. In both groups patients will also be receiving inhaled steroids.~   "
217945|NCT00706433|"~     The purpose of this study is to determine and compare the safety and efficacy of multiple~     broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle~     (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.~   "
217923|NCT00706745|"~     Rationale: Cis-9, trans-11 conjugated linoleic acid (CLA) can protect against the~     atherosclerosis development in several animal models. Studies in transgenic mice have shown~     that mechanisms might involve beneficial effects on lipoprotein metabolism and insulin~     sensitivity and in addition activation of anti-inflammatory pathways. A very limited amount~     of human studies have not shown similar beneficial effect of cis9,trans11-CLA on insulin~     sensitivity in obese subjects, yet cis9,trans11-CLA did improve the lipoprotein profile in~     healthy subjects. The effect of cis9,trans11-CLA supplementation on alternative early~     biomarkers of atherosclerosis, like aortic pulse wave velocity, and alternative biomarkers~     identified through platelet proteomics, has not been assessed before, and may add valuable~     insights into the mechanism of this functional fatty acid in humans.~      Objective: To assess the effect of increased intake of cis9 trans11-CLA on development of~     atherosclerosis, as assessed with aortic pulse wave velocity and on alternative biomarkers.~      Study design: The study is designed as a double blind randomised placebo controlled parallel~     group trial.~      Study population: 400 men and women, between 40 and 70 years of age, with a body mass index~     of 25 kg/m2 or above. Subjects with previous symptomatic vascular disease or diabetes~     mellitus and subjects on blood pressure lowering or lipid lowering medication are excluded.~      Intervention: Subjects in the intervention arm will receive daily 4 g of CLA oil (2.6 g~     cis9,trans11-CLA), 2 capsules to be taken in the morning and 2 in the evening. The subjects~     in the control arm receive 4 identical placebo capsules.~      Main study parameters/endpoints: The main study outcome is difference between treatment arms~     in change in aortic pulse wave velocity after 6 months intervention.~   "
217924|NCT00706732|"~     The objective of this study is to evaluate the safety of the vaccine and the immune response~     to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be~     assigned by randomization to receive either the vaccine or an inactive substance (placebo) by~     injections in the arm on two occasions over one month. The study will last approximately 10~     months and will have a total of 7 visits.~   "
217925|NCT00706719|"~     The study was designed to determine if Androxal® would affect sperm parameters (count,~     concentration, volume) in men with secondary hypogonadism who have been previously treated~     with topical testosterone.~   "
217926|NCT00706706|"~     To investigate safety and efficacy of single agent sunitinib malate as first-line systemic~     therapy in Chinese patients with metastatic renal cell carcinoma.~   "
217927|NCT00706693|"~     The purpose of this study is to determine the most effective treatment option for managing~     naturally occurring hypoglycemia in children with type 1 diabetes.~      Hypotheses:~        1. Sucrose and Fructose are equally effective as glucose in the treatment of spontaneous~          hypoglycemia in children with type 1 diabetes.~        2. Children and teens will use a variety of treatment practices for the management of~          hypoglycemia.~        3. Children and teens will prefer the mode of treatment that was most effective in treating~          hypoglycemia.~   "
217928|NCT00706680|"~     This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine~     and early steroid dosage reduction will minimize both kidney rejection and the development of~     new onset diabetes mellitus after renal transplant.~   "
217929|NCT00706667|"~     Study Design: Single-centre, block randomised, blinded, controlled, phase IIIb, parallel~     group pilot study.~      Primary Objective:~      • To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or~     without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status~     in patients undergoing orthopaedic surgery~      Secondary Objective:~        -  To gain informations for the design of a possible follow-up study~        -  To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with~          or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative~          Hb levels, iron status, transfusion rate, days until discharge.~        -  To evaluate the tolerability and safety of Ferinject®~      Study Centres:~      This is a single centre study~      Patients:~      A total of 75 completed patients (50 patients in the intravenous iron treatment groups and 25~     patients in the no treatment group will be recruited.~   "
217930|NCT00706654|"~     The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an~     intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients~     with schizophrenia~      The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject~     to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole~     monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be~     stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in~     Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are~     eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During~     Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending~     relapse for up to 38 weeks.~   "
217931|NCT00706641|"~     This pilot study is designed to determine feasibility and safety of treatment with dasatinib~     administered orally once daily for 4 weeks duration prior to radical cystectomy for~     urothelial carcinoma of the bladder.~   "
217932|NCT00706628|"~     The primary objective of this trial is to estimate and compare the 12-week progression-free~     rate of BIBF 1120, BIBW 2992 or sequential administration of BIBF 1120 and BIBW 2992 in~     patients with HRPC as determined by radiographic, bone and PSA criteria.~   "
217933|NCT00706615|"~     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating women with previously treated metastatic breast cancer.~   "
217946|NCT00706420|"~     The purpose of this study is to evaluate the safety and effectiveness of islet cell~     transplantation alone (ITA) in patients with difficult to control type I diabetes. Difficult~     to control type 1 diabetes is defined as wide swings in blood glucose that disrupt the~     patient's life and result in frequent episodes of low blood glucose despite the proper use of~     standard insulin therapy and frequent blood glucose monitoring.~   "
217960|NCT00706238|"~     This study is being done to evaluate the safety and the clinical activity of MAGE-A3~     Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive~     metastatic cutaneous melanoma.~   "
218484|NCT00699322|"~     This research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and~     improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in~     type 2 diabetic patients with inadequate glycemic control on metformin~   "
217934|NCT00706602|"~     Background: COPD is a systemic illness; morbidity and mortality due to this disease are on~     the increase, and it has great impact on patients' lives. Most COPD patients are managed by~     general practitioners (GP). GPs base their initial assessment of patients' disease severity~     mainly on lung function and then inform patients about adequate treatment. However, lung~     function correlates poorly with COPD-specific health-related quality of life and exacerbation~     frequency. Preventive cardiology embraced risk index-guided treatment successfully. COPD~     disease severity indices that better represent the clinical manifestations of COPD are needed~     that can be used to guide risk-stratified treatment.~      Objectives: (1) The development and validation of a practical COPD disease severity index to~     predict the course of health-related quality of life over time. (2) The validation of the~     ADO-Index (Age, Dyspnea, Obstruction) to predict 3-year mortality in COPD patients in primary~     care. (3) Link evidence on treatment effects to the COPD risk indices to guide COPD treatment~     selection.~      Methods: We are in the process of conducting two linked prospective cohort studies with 413~     COPD patients (GOLD stages 2-4) from GPs in Switzerland and the Netherlands. We performed a~     sound baseline assessment including detailed patient history, lung function, measurement of~     exercise capacity and blood sampling. During the follow-up of at least five years, we update~     the patients' profile by registering health status, exacerbations and health-related quality~     of life and, after 2 years, lung function and measurement of exercise capacity. For aim 1, we~     will identify the best combination of variables predicting the course of health-related~     quality of life over time using multivariable regression analysis. For aim 2, we will assess~     discrimination and calibration of the ADO index to predict 3-year mortality. For aim 3, we~     will estimate treatment effects for individual patient profiles using complex statistical~     models such as Markov models.~      Significance of project: After this study, different risk scores will be available for use in~     primary care so that general practitioners can estimate what impact COPD will have on the~     patients. By linking these risk scores to evidence form treatment studies, it will be~     possible to show for an individual patient how COPD and different treatments impacts on~     mortality, symptoms and exacerbations. Thereby, patients and physicians can make more~     informed treatment decisions balancing the benefits and downsides of different treatments.~   "
217935|NCT00706589|"~     The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in~     children and adolescents aged 6~18 years with chronic tic disorders or Tourette's disorder~   "
217936|NCT00706576|"~     Hepatocellular cancer, one of the world's most deadly tumors, is associated with chronic~     liver injury and cirrhosis. With the increasing occurrence of viral hepatitis, the incidence~     of this cancer in the United States continues to rise. Surgical resection offers the only~     hope for cure; but sadly, few patients are candidates for surgery due to their liver disease.~     Liver transplant can be an effective treatment, but due to a scarcity of organs, most~     patients do not qualify for this therapy either. Patients who are not candidates for these~     procedures have very few therapeutic options as chemotherapy and radiation have little~     efficacy. New therapies are desperately needed.~      Opioid Growth Factor (OGF) inhibits the growth of a number of cancer lines in vitro by a~     receptor-mediated mechanism. In pancreatic cancer this phenomenon has been well defined not~     only in vitro but in animal models. Based upon these findings, a phase I trial has been~     conducted demonstrating that OGF can be administered safely to patients with pancreatic~     cancer. The investigators hypothesize that administration of OGF will inhibit the course of~     cancer progression in human subjects with unresectable hepatocellular cancer and cirrhosis.~     As a first step in testing this hypothesis, the investigators propose a phase I trial to~     study the toxicity and pharmacokinetics of this therapy in patients suffering from inoperable~     hepatocellular cancer and cirrhosis.~   "
217937|NCT00706563|"~     This study is designed to test the immunogenicity and reactogenicity of the~     Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for~     the 2008-2009 season.~   "
217938|NCT00706550|"~     The purpose of this study is to evaluate the best timing for administering pneumococcal~     vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not~     yet receiving combination antiretroviral treatment (ART). Participants in this study will be~     assigned by chance to receive vaccination with PV prior to starting ART or after at least 6~     months of ART. Antibody levels to components of the PV will be measured at 6 months and 12~     months after vaccination. The results will tell us if patients that receive PV after 6 months~     of ART have better response to the vaccine than those that get vaccinated prior to treatment.~   "
217939|NCT00706537|"~     CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being~     developed for the treatment of obesity. CP-945598 is also being considered as a potential~     treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the~     steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of~     CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH~     patients and underwrite the safety of this compound prior to any further studies in NASH~     patients.~   "
217940|NCT00706511|"~     The purpose of this study is to look at the metabolic (use of energy) and hormonal features~     of sleep problems in men and women.~   "
217941|NCT00706498|"~     A study to investigate the activity of BI 2536 in Prostate Cancer~   "
217942|NCT00706485|"~     The purpose of this clinical trial is to determine the feasibility of the Y-90 plaque~     applicator. The Y-90 plaque application is designed to deliver high doses of radiation to~     tumors in the spine that involve dura (the tough outer layer of the spinal cord). Tumors in~     the spine need a high dose of radiation to kill cancer cells. The nearby spinal cord is a~     sensitive area which does not safely tolerate high doses of radiation. The Y-90 plaque~     applicator is a special technique used to deliver the radiation dose to the tumor cells and~     avoid the spinal cord.~   "
217943|NCT00706459|"~     In this study, we will use advanced and newly available MR imaging techniques at 3 Tesla~     (including in situ axial loading and quantitative T1rho, T2, and diffusion measurements) to~     assess the intervertebral discs and adjacent vertebrae in patients with lumbar back pain~     scheduled for back surgery (n=20), patients with degenerative disease without classic~     discogenic back pain (n=10), patients who had discectomies for herniated discs (n=5), and~     age-matched volunteers without back pain (n=10). In all patients standard imaging procedures~     will also be performed, including radiographs, standard MRI at 1.5 Tesla and discography. All~     patients will have specimen of the intervertebral disc harvested at surgery and pathologic~     analysis and spectroscopy of these specimen will be performed. Post-surgical findings/outcome~     combined with discography will serve as a standard of reference for the identification of the~     painful disc(s). The diagnostic performance of the new techniques in assessing the painful~     disc will be evaluated. We will collect disc specimens from 50 patients undergoing back~     surgery but did not have pre-surgical MR imaging. These disc specimens will be analyzed in~     the same manner as the specimens collected from surgical patients who had pre-surgical MRI.~     This study will serve as a pilot study for a larger project focusing on advanced imaging of~     the painful intervertebral disc.~      We hypothesis that advanced, dedicated MR examinations at 3T can identify painful degenerated~     discs in patients with chronic lumbar back pain.~   "
218485|NCT00699309|"~     The purpose of this prospective clinical data-collection is to document the performance and~     clinical outcomes of the Taperloc® Microplasty™ Hip System.~   "
217947|NCT00706407|"~     The purpose of this experiment is to confirm the results of previous testing of Urodynamix's~     Uro-NIRS device. Together Urodynamix and Laborie have created a device that includes standard~     Laborie medical equipment and the experimental Urodynamix device. Collectively this~     integrated device is considered an investigational device, and the results from this study~     may be used to support a submission to the US Food and Drug Administration for the approval~     of the integrated device.~      This research is being done because we want to test the ability of the integrated Laborie and~     Urodynamix device to provide a non-invasive method to provide additional information to~     assist with the diagnosis of or treatment plan of patients suffering from urinary problems.~     The current technologies rely solely on the measurement of internal pressures of the bladder,~     which involves the insertion of catheter into the subject's urethra.~   "
217948|NCT00706394|"~     Study of anatomical fixation with a 34mm proximal extension~   "
217949|NCT00706381|"~     Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in~     utilization of energy by the human body following a meal. The mechanisms involved in this~     process are believed to differ according to the type of food consumed, whether fat, protein~     or carbohydrate.~      The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a~     meal, play an important role in the absorption of fat and the management of cholesterol~     stores in the body. Recent studies suggest that BAs may also serve as regulators of energy~     expenditure (consumption) in the cells of our body by increasing the production of T3, an~     active form of thyroid hormone. T3 in turn is believed to increase the efficiency with which~     our bodies burn calories thereby generating heat. Although this process has been shown to be~     effective in rodents who demonstrated weight loss after treatment, the role of BAs in humans~     is poorly understood. Thus we do not know whether endogenous (produced by the body) or~     exogenous (taken as medication) BAs play a significant role in the maintenance of body~     weight. We hypothesize that, similarly to rodents, humans will respond to BAs by increasing~     energy expenditure via the production of the active form of thyroid hormone.~      This randomized, cross-over study will look at changes in thyroid hormones and energy~     consumption in response to stimuli of endogenous BA secretion including dietary content, and~     to the intake of pharmacological doses of bile acids.~      Following a two-day period of equilibration diet, 30 healthy volunteers will be randomly~     assigned to receive either a high-fat or high-carbohydrate isocaloric meal followed by a~     6-hour metabolic chamber stay; the next day they will be crossed-over to the alternate~     intervention. During the following three days, the study subjects will again be randomized to~     receive either an intravenous injection of sincalide (the C-terminal octapeptide fragment of~     cholecystokinin) 0.04 mcg/kg or placebo and P.O. placebo, or I.V. placebo and 15 mg/kg of BA~     (ursodiol) with similar metabolic chamber stays and cross-over design.~      The following parameters will be recorded and compared to placebo:~      Energy expenditure~      Substrate utilization~      Spontaneous movements~      Skin and core temperature~      Serial changes in circulating thyroid hormones~      Serial changes in bile acid serum concentrations~      The data gathered from this study will provide greater insight into the physiological and~     molecular mechanism(s) regulating the relation between endogenous bile acid secretion and~     energy metabolism in response to meals, as well as the role of BAs per se on energy~     metabolism.~   "
217950|NCT00706368|"~     Symptoms of vaginitis are common among adolescent females, although studies have shown that~     neither experienced clinicians nor patients can accurately diagnose the cause of vaginitis~     based on symptoms alone. The purpose of this study is to investigate the accuracy and~     acceptability of self-diagnostic methods for vaginitis in adolescent females.~   "
217951|NCT00706355|"~     PF-04217903 may work in cancer by blocking the cell growth, migration and invasion of tumor~     cells. PF-04217903 is a new member in a class of drugs called c-Met/hepatocyte growth factor~     receptor tyrosine kinase inhibitors. This research study is the first time PF-04217903 will~     be given to patients. PF-04217903 is taken by mouth daily.~   "
217952|NCT00706342|"~     The purpose of this study is to determine whether Fostamatinib Disodium is safe and effective~     in the treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP).~   "
217953|NCT00706329|"~     The purpose of the study is to test the use of Deflux injections in a minimally invasive~     closure of umbilical (belly button) hernias in infants between birth and five years. The~     study is designed to demonstrate that the use of this device can safely and effectively close~     an umbilical hernia.~   "
217954|NCT00706316|"~     Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant~     spread, NPC is sensitive to radiotherapy and chemotherapy; however, if NPC relapses or~     spreads to other organs, treatment options are limited. This grant proposes to evaluate the~     safety and tolerability of a novel treatment for patients with NPC that has either relapsed~     or spread to distant organs. Epstein-Barr Virus (EBV) is known to play a role in the~     development of NPC, and studies have shown that NPC tumor cells express proteins that are~     related to EBV. Some of these proteins can trigger a response from the immune system,~     specifically the activation of cytotoxic T lymphocytes (CTLs), a type of immune cell that~     might exert anti-tumor effects. In this project, we will take blood from NPC patients,~     generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to~     achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to~     CTL infusion in order to allow for better expansion of the infused CTLs in the patients.~   "
217955|NCT00706303|"~     Training patients to alter their own therapy early in the course of a developing exacerbation~     (self-management) has been shown to improve outcomes in asthma, but there is no good evidence~     on this for patients with Chronic Obstructive Pulmonary Disease (COPD). Case management, with~     patients having an identified contact who helps them access care when necessary, has been~     shown to improve outcomes in recent studies. A combined approach, called supported~     selfmanagement, may be particularly suitable for this socially and often educationally~     disadvantaged group of patients.We propose to identify 500 patients at the time of an~     exacerbation to test this combined strategy in a randomised manner. The primary outcome~     measure will be readmission to hospital or death due to COPD, important in terms of patient~     preferences, quality of life and health costs. This will provide important information about~     intermediate care for COPD patients which should influence service provision within the NHS~     in Scotland~   "
217956|NCT00706290|"~     RATIONALE: Providing cognitive-behavioral therapy (CBT) may reduce anxiety and improve~     quality of life of patients with advanced cancer.~      PURPOSE: To examine the development and pilot testing of a brief cognitive-behavioral therapy~     intervention to treat anxiety and improve quality of life in patients with advanced cancer.~      Hypothesis: Patients with anxiety associated with advanced cancer who receive CBT will report~     significantly fewer anxiety symptoms compared to those in the comparison condition.~   "
217957|NCT00706277|"~     The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA;~     propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl;~     maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30~     minutes after emergence from the general anesthesia.~   "
217958|NCT00706264|"~     Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in~     pregnant women with short cervical length at 18-22 weeks scan.~   "
217961|NCT00706225|"~     Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which~     is being studied for possible prevention and treatment of postmenopausal osteoporosis.~      PREMARIN® (conjugated estrogens [CE]) is approved by FDA to treat moderate to severe symptoms~     of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of~     postmenopausal osteoporosis.~      The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution,~     breakdown and elimination in the body) of a single dose of PREMARIN® when administered~     together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women.~      Information will also be obtained regarding the safety and tolerability of the study~     medications when given together to healthy postmenopausal women.~   "
217962|NCT00706212|"~     PET CT is one of the imaging tools that are used for staging of urological malignancies.~      C11 Choline is a novel isotope with the advantage of its minimal secretion in the urine. This~     advantage makes it a potentially better metabolic marker then others such as FDG. Preliminary~     studies showed ~95% sensitivity in the diagnosis of TCC. Our Goal is to continue the~     evaluation of this method as a diagnostic and follow up tool in different urological~     malignancies.~   "
217963|NCT00706199|"~     Antigen expression levels in bone marrow from volunteering donors will be analyzed. The~     results of this analysis will be used to establish a clinical test to identify cancer~     patients who could qualify to receive an investigational treatment being developed by~     GlaxoSmithKline.~   "
217964|NCT00706186|"~     Eligible patients will undergo this open label initial safety and feasibility study~     investigating the use of 6 g/day sodium oxybate in mild AD. A total of 5 visits are included~     with this trial and total subject participation duration of 7-8 weeks. The screening phase~     will include an initial screening visit and a screening PSG night. After successful~     screening, subjects will complete a baseline PSG night and undergo a third PSG night to~     monitor initial safety and compliance with study drug at a dosage of 4.5 g/day of sodium~     oxybate. Thus the subject will undergo three consecutive nights of PSG in the sleep center.~     The patient will maintain a dosage of 4.5 g/day for a duration of 7 days leading to Treatment~     Visit 1. After successful assessment at Treatment Visit 1, the dosage will be increased to 6~     g/day for the duration of the trial. At Treatment Visit 2 (day 21), the dosage will be~     increased to a dosage of 9 g/day, if tolerated by the patient. The remaining visit will occur~     at 6 weeks after baseline, with Treatment Visit 3 consisting of two consecutive nights of~     PSG. Participation will be complete after this visit. Phone follow-up will be made at one~     week post completion visits to assess any wash-out symptoms. Please refer to Figure for flow~     of the study design.~   "
217965|NCT00706173|"~     Developing novel and effective pharmacologic interventions for this post-traumatic stress~     disorder is important. The investigators propose to replicate findings of an earlier~     published pilot study using low dose hydrocortisone as a treatment for PTSD. In order to do~     so in a more meaningful way, the investigators will conduct a larger but similar randomized~     double-blind placebo-controlled, cross-over design treatment study examining the use of low~     dose hydrocortisone (or placebo) for 4 weeks in combat veterans suffering from PTSD.~      The investigators hypothesize that, as described by Aerni et al. (2004), administration of~     daily hydrocortisone will lead to a reduction in PTSD symptom severity, but particularly for~     re-experiencing types (e.g., flashbacks, nightmares)of symptoms. The investigators also hope~     to examine potential predictors and moderators of treatment response based on subjects'~     clinical characteristics, as well as serum cortisol and ACTH levels.~   "
217966|NCT00706160|"~     This study will examine how certain language skills, such as naming objects, understanding~     spoken language and reading are organized in the brain and how they are affected by seizures.~      People with epilepsy who are considering surgery and healthy volunteers who are right-handed~     and between the ages of 7 and 55 may be eligible for this study. Participants undergo the~     following procedures twice, and, in some cases, possibly three times, in two or three visits~     of 2 to 4 hours each.~      Neuropsychological tests: Testing includes questionnaires, pen-and-pencil or computerized~     tests and motor tasks.~      Structural MRI: This procedure uses a strong magnetic field and radio waves to obtain~     pictures of brain structure. During the test, the subject lies in the scanner (a metal~     cylinder surrounded by a magnetic field) for about 90 minutes, wearing earmuffs to muffle~     knocking noises the machine makes. Subjects may be asked to lie still for up to 10 minutes at~     a time.~      Functional MRI: This procedure is similar to structural MRI, except a coil is placed over the~     head and the subject performs simple tasks during the procedure. The pictures obtained show~     what parts of the brain are being used to perform the task. The test lasts about 60 minutes,~     with subjects asked to lie still for up to 10 minutes at a time.~      Magnetoencephalography (MEG) and electroencephalography (EEG): For MEG, the subject sits in~     an MEG recording room with a cone containing magnetic field detectors lowered onto his or her~     head. Very small magnetic changes produced by the activity of the brain are recorded while~     the subject sits quietly or performs a research task. An EEG recording of the electrical~     activity of the brain is done at the same time as the MEG.~   "
217967|NCT00706147|"~     The purpose of this study will be to demonstrate the safety, tolerability, and efficacy of~     arimoclomol in subjects with SOD1 positive familial Amyotrophic Lateral Sclerosis (ALS). This~     type of ALS is HEREDITARY (runs in families), and at least one other person in the family~     must have had ALS.~      Study hypotheses: Arimoclomol, taken at a dose of 200 mg three times daily will improve~     survival as defined by time to death, tracheostomy or permanent assisted ventilation. In~     addition, it will be safe and well tolerated in subjects with SOD1 positive familial ALS.~      Funding Source - FDA-OOPD~   "
217968|NCT00706134|"~     This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in~     elderly patients with essential hypertension when given with a light meal.~   "
217969|NCT00706121|"~     RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on~     the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors~     predict a participant's response to treatment and help plan the best treatment.~      PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on~     colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.~   "
217986|NCT00705900|"~     The purpose of this study is to compare the safety and effectiveness of a new topical LCD~     solution and a commercially available calcipotriol (Vitamin D) cream in reducing the symptoms~     of plaque psoriasis and improving the quality of life in adults.~   "
217970|NCT00706108|"~     The impact of different coordination patterns on team performance during anesthesia~     inductions are analyzed using videotapes. These records are examined using various~     categorization systems (ETHZ), focussing on changes of coordinative behaviour with shifting~     situational requirements. A rating system comprising multiple categories is used to evaluate~     team performance. An integrated simulator study facilitates validation of the rating system.~   "
217971|NCT00706095|"~     This is an open-label, three-parallel group pharmacokinetic study. Patients with advanced~     solid tumors will be assigned to one of three groups to receive I.V. doses of eribulin~     (E7389). The three groups are: normal hepatic function, mild hepatic impairment (Child-Pugh~     A) and moderate hepatic impairment (Child-Pugh B) according to the Child-Pugh System for~     classifying hepatic impairment.~   "
217972|NCT00706082|"~     A two-stage prospective observational cohort study in scleroderma patients to evaluate~     screening tests and the incidence of pulmonary arterial hypertension and pulmonary~     hypertension~   "
217973|NCT00706069|"~     This study will evaluate the toxicity and secondary the efficacy of the combination~     vinorelbine plus capecitabine in metastatic breast cancer patients~   "
217974|NCT00706056|"~     The objective of this study is to determine whether systemic blood pressure in the body is~     related to the development and progression of normal tension glaucoma in the eye. The study~     aims to clarify whether subjects with episodes of hypotension (low blood pressure) at night~     are at increased risk for sight loss and the development of normal tension glaucoma.~   "
217975|NCT00706043|"~     Low back pain is a very common disease. Among the persons suffering of acute low back pain,~     about 10% are at risk of developping chronic pain. A screening questionnaire assessing this~     risk has been developed and validated in Swedish and English (Orebro Musculoskeletal Pain~     Screening Questionnaire, Linton, 2003). The aim of our study is to validate a french~     translation of this questionnaire. Patients suffering from acute low back pain will be asked~     to fill in several questionnaires at day 0, and 6 and 12 month later.~   "
217976|NCT00706030|"~     The purposes of this study are to identify the highest tolerable dose of neratinib (HKI-272)~     in combination with vinorelbine and to assess the safety of the combination of the two drugs~     as well as to obtain preliminary information on whether the combination of the two drugs has~     any effect on solid tumors.~      The study will be conducted in two parts. In the first part, testing will be done on up to 12~     subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with~     advanced solid tumors. In the second part of the study, approximately 60 additional subjects~     with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are~     planned to be added to better define the tolerability and preliminary activity of HKI-272 in~     combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer~     with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory~     analyses.~   "
217977|NCT00706017|"~     This observational study is conducted in North America. The aim of this observational study~     is to evaluate the incidence of adverse events while using Levemir® under normal clinical~     practice conditions.~   "
217978|NCT00706004|"~     The purpose of this study is to determine the short term safety and effectiveness of~     lubiprostone when used for constipation in adults with cystic fibrosis.~   "
217979|NCT00705991|"~     Das Hauptziele der Studie ist das ROTEM® zu validieren durch die Untersuchung von:~      i) Reproduzierbarkeit von ROTEM® ii) Präzision der ROTEM®-Tests, sowie iii) der Zeitspanne,~     während derer die Ergebnisse in Zitrat-Blut reproduzierbar sind~      Die durchzuführenden Tests sind FIBTEM, EXTEM, INTEM in ROTEM® um die Funktion der~     Thrombozyten während der Lagerungszeit zu untersuchen.~      Nur Zitrat-Blut wird den Patienten abgenommen, die Reklazifikation findet kurz vor der~     Durchführen der Tests stattfinden, um so nahe wie möglich an der klinischen Praxis zu sein.~   "
217980|NCT00705978|"~     This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term~     safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be~     assessed and correlated with CFA.~   "
217981|NCT00705965|"~     In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly~     relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of~     the current study is to evaluate the effects of a psychotherapy intervention on symptoms of~     depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be~     randomised into a controlled intervention trial, comparing a stepwise psychotherapy~     intervention with usual cardiological care. The manualized psychotherapy intervention starts~     with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression~     will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25~     sessions of psychodynamic group psychotherapy over a total period of one year. The~     psychodynamic approach was chosen in order to specifically take into account personality~     traits such as negative affectivity and social inhibition, the components of the Type D~     personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials~     produced only small effects in depressed CAD patients. The investigators expect that the~     intervention will reduce depressive symptoms as well as the prevalence of depressive~     disorders. It will also improve both behaviourally and physiologically mediated~     cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs.~     Subgroup analyses will be performed in order to identify gender-specific treatment effects,~     effects on immunological stress reactivity, and genetic predictors of treatment success.~   "
217982|NCT00705952|"~     The purpose of the study is to assess whether weight loss achieved through a programme of~     intensive lifestyle management can result in enhanced production of Glucagon-Like Peptide-1~     (GLP-1) together with improvements in the release of insulin and glucagon and thus~     improvements in glycaemic control (HbA1c), in patients with new onset type 2 diabetes.~      This is a cohort study with comparisons made between assessments at baseline, after an~     initial four months of intensive intervention and after a further four months follow up~     (maintenance period). Each patient will participate in the study for 8 month. The entire~     study period will be 24 months.~      All patients with new onset type 2 diabetes (within 2 weeks of diagnosis) will be recruited~     from those referred to the Type 2 Diabetes Education Programme in the community (FOCUS), as~     per standard practice. The investigators will also hope to recruit direct from local GP~     surgeries who will be advised of the study. At this point, patients will be given a study~     information sheet with a contact number if they wish to participate in the study.~      Individuals who are unable to give consent, who would be unable to attend all the programme~     sessions for medical or other reasons, who are prescribed oral hypoglycaemic, antiobesity or~     any other prescription medications that may interfere with the study results or whose BMI is~     < 25, will be excluded. The investigators will also exclude those who cannot converse~     competently in English as special arrangements would need to be made for such people~     attending the programme and this would be impractical in a group setting.~      Those willing to participate will be invited for an individual appointment with the~     dietitian, during which the study structure, aims and procedures will be explained and~     consent to participate in the study will be obtained. For the first session of the programme,~     participants will be asked to attend following an overnight fast. Blood samples will be taken~     for basal measurement of glucose, HbA1c, lipids, insulin, glucagon, GLP-1, leptin, ghrelin~     and adiponectin. They will then be given a standard 75 g glucose load and sampling repeated~     at 30 mins (for peak GLP-1 levels). Baseline measurements of weight, height, percent body~     fat, waistline circumference and blood pressure will also be taken during this session.~     Following the assessment, patients will participate in the first session of the education~     programme. The full assessment will be repeated at 4 and 8 months intervals.~      The weight management programme will be run by the Specialist Dietitian. It will consist of 2~     phases: an initial 4 month intensive weight loss phase, followed by a 4 month weight loss /~     maintenance phase. The initial four month programme will consist of 8 group education~     sessions and at least 3 phone calls. The following 4 month programme will consist of 5 group~     sessions, at least 3 phone calls and 1 individual appointment. Each education session will~     last 60min. Before the 1st session and, at 4 month and 8 month sessions, bloods will be~     taken, as above. Before the rest of the sessions, there will be 15 minutes devoted to weight~     assessment. The programme will be based on portion control and healthy eating and will be~     supported by behavioural and cognitive change interventions. Such interventions will include~     self monitoring, stimulus control, goal setting, problem solving and relapse prevention. The~     specialists from Bournemouth HealthLink (a partnership backed by the local NHS, Council and~     University) will take part in helping participants to increase their activity levels.~      The aim is to achieve weight loss of 5% over the first 4 months with, as a minimum, weight~     maintenance or possible further reduction over the subsequent four months.~   "
217983|NCT00705939|"~     Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the~     human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme~     glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in~     the cells of the monocyte-macrophage system.~      This is an extension trial to Study NCT00376168 and NCT00712348.~   "
217984|NCT00705926|"~     This study will determine whether HIV treatment that is initiated during the acute phase of~     HIV infection, followed by discontinuation of treatment, is effective in reducing the amount~     of HIV and an increasing the amount of CD4 cells in the blood of people with HIV, compared to~     the amounts of HIV and CD4 cells in people who do not receive treatment at this stage.~   "
217985|NCT00705913|"~     The purpose of this study is to compare sizing,implant techniques, and hemodynamics between~     the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.~   "
217987|NCT00705887|"~     The specific aims of this research are:~      Aim 1 - To describe the UV protection behaviors and beliefs of young adult patients in a~     dermatology clinic.~      Aim 2 - To examine whether or not the UV protection behaviors and beliefs of young adult~     dermatology patients are associated with age, gender, level of education, marital status,~     contact with skin cancer, time outdoors, skin type, the reason for their visit, and the date~     of data collection.~      Aim 3 - To test the efficacy of a motivational enhancement approach to UV protection~     counseling for young adult dermatology patients, as manifested by favorable changes in UV~     protection stages of change, UV protection self-efficacy, and UV protection attitudes.~   "
217988|NCT00705874|"~     This study will aims to determine the maximum tolerated dose of CGC-11047 when used in~     individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or~     cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047~     will be escalated until the maximum tolerated dose is established.~   "
217989|NCT00705861|"~     The purpose of this study is to evaluate the efficacy and safety of SK3530 on erectile~     dysfunction in Patients with Diabetes Mellitus.~   "
217990|NCT00705848|"~     It is not clearly understood what causes tracheobronchomalacia (weakening of the windpipe and~     airways) or tracheal stenosis (narrowing of the windpipe). We plan to take biopsies (small~     pieces of tissue) and brushings (to collect the cells that form the lining of the airway)~     from the airways of patients with these diseases and analyze these samples in a laboratory to~     try and determine the mechanism of disease. We will compare the results with that of patients~     with normal airways.~   "
217991|NCT00705835|"~     The purpose of this research is to help us study a vaccine treatment for patients with~     prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections~     and other diseases, such as cancer. Your immune system is made up of many different types of~     cells which fight infection and disease in your body. A vaccine may stimulate the immune~     system to destroy the cancer cells. It may also help to slow the growth of the cancer. The~     vaccine is a solution given as an injection into or under the skin. It is made up of several~     parts. The first part is PSMA, a protein present in many cancers, especially prostate cancer.~     It is referred to as rsPSMA when made in a laboratory for this study and is mixed with a~     material called Alhydrogel® (aluminum hydroxide suspension) which helps the immune system to~     make more cancer-fighting cells.~   "
217992|NCT00705822|"~     To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and~     experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values.~      To determine the time to treatment failure in both strategies To determine the overall and~     specific cause survival To evaluate the safety profile To analyze the Quality of Life~   "
217993|NCT00705809|"~     Background:~        -  The T-Cell Project, sponsored by the International T-cell non-Hodgkin Lymphoma Study~          Group, is a consortium of institutions interested in achieving more detailed information~          on clinical and biological characteristics of T-cell lymphomas.~        -  The T-Cell Project serves as a repository for data on patients with peripheral T-cell~          lymphoma (PTCL) worldwide. Its overall goal is to improve T-cell subtype classifications~          and evaluate treatment strategies for each subtype.~      Objectives:~      -To implement a standardized epidemiologic questionnaire into the ongoing T-Cell Project to~     allow evaluation of various potential risk factors for PTLCs.~      Eligibility:~      -Untreated patients 18 years of age and older who were diagnosed with PTLC September 1, 2006,~     or later.~      Design:~      -Patients complete a questionnaire containing the following information:~      Demographic information~      Smoking history and alcohol use~      Personal history or cancer~      History of cancer among first-degree relatives~      Medical history~      History of transplants~      History of blood transfusions~      Medication use~      Occupational and residential history~      Pesticide treatment~      -The information collected is linked to clinical and pathologic information in the T-Cell~     Project database.~   "
217994|NCT00705796|"~     Exogenously administered testosterone will override the normal negative feedback of~     endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and~     constant testosterone levels will cause a drop in FSH and LH production by the pituitary.~     Since FSH and LH are signalling hormones to the testes, endogenous testosterone production~     and spermatogenesis will be down-regulated. It is expected that intranasal dosing in the~     morning will mimic the normal physiological pattern of testosterone production thereby~     avoiding negative side-effects on spermatogenesis. Trans-dermal gels give testosterone levels~     more or less constant over the day and will very likely have inhibitory effects on~     spermatogenesis.~      The main objective of this study is to show that twice daily intranasal dosing does not have,~     or has a smaller inhibitory effect on spermatogenesis in comparison to transdermal~     testosterone gels.~   "
217995|NCT00705783|"~     The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an~     intramuscular depot formulation of aripiprazole as maintenance treatment in patients with~     schizophrenia.~      The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient~     to be converted from their current antipsychotic treatment to oral non-generic aripiprazole~     monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was~     stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a~     minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2,~     they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization~     phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole~     formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was~     stabilized, they were eligible to be randomized into the double-blind IM depot maintenance~     phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic~     symptoms and/or impending relapse for up to 52 weeks.~   "
217996|NCT00705770|"~     The purpose of this study is to determine whether Anecortave Acetate is effective for~     lowering intraocular pressure caused by open-angle glaucoma.~   "
217997|NCT00705757|"~     The purpose of this study is to study changes in skin color that may be caused by using one~     of the three eye medicines: Xalatan, Travatan or Lumigan.~   "
217998|NCT00705744|"~     To prove the absence of photo irritation and photo sensitivity potential of the product~     Dermacyd Femina.~   "
218066|NCT00704808|"~     The purpose of this surveillance is to collect more safety and efficacy data in non-study~     patients during concomitant and adjuvant temozolomide therapy.~   "
217999|NCT00705731|"~     This study will compare patient adherence to different colorectal cancer (CRC) screening~     tests to identify the most cost-effective strategy to decrease mortality from CRC. We~     hypothesize that different types of tests will have different adherence rates, that these~     rates will alter the cost-effectiveness analysis, and that we can identify patient variables~     associated with non-adherence to specific CRC screening strategies.~   "
218000|NCT00705718|"~     To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of~     Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.~   "
218001|NCT00705705|"~     This study will determine whether an HIV prevention program that targets the inner workings~     of social networks at high risk for HIV and other sexually transmitted diseases is effective~     in reducing frequency of high-risk sexual behaviors among network members.~   "
218002|NCT00705692|"~     Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to~     Hepatitis B virus (HBV) vaccination in hemodialysis patients. The aim of this study was to~     evaluate the effect of levamisole supplementation on tetanus-diphtheria (Td) vaccine response~     rate in hemodialysis patients.~   "
218003|NCT00705679|"~     A new approach to HIV prevention currently being studied includes the use of microbicides,~     substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and~     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV drugs,~     and tenofovir gel is an experimental microbicide. The purpose of this study is to determine~     the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and~     the safety and effectiveness of oral TDF and oral FTC/TDF compared to an oral placebo in~     preventing HIV infection among women at risk for sexually transmitted infections.~   "
218004|NCT00705666|"~     In February 2002, a French Consensus Conference on the management of patients with chronic~     hepatitis C in France was organized. The jury issued several recommendations on pegylated~     alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is~     of interest to understand the evolution of hepatitis C management in France in real clinical~     practice. This observational study will permit the identification of patients who are treated~     and will provide information on the use of PegIntron/ Ribavirin.~   "
218005|NCT00705653|"~     This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and~     to establish what happens to the drug once inside the body. An escalating dose of PG-11047~     will be investigated in this study and the maximum tolerated dose of the drug will be~     established.~   "
218006|NCT00705640|"~     RATIONALE: Vaccine therapy may help the body build an effective immune response to kill tumor~     cells.~      PURPOSE: This randomized clinical trial is studying how well vaccine therapy works in~     treating patients with advanced melanoma.~   "
218007|NCT00705627|"~     Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002~     Classification) can be divided into two groups according to the risk of metastasis: high-risk~     metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis~     group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance~     metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is~     also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT~     alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance~     metastasis in patients with high-risk metastasis group. In this case, it is utmost important~     to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to~     improve overall survival of locoregionally advanced NPC with high-risk metastasis.~      In our study, in order to investigate the effect and adverse reaction of neoadjuvant~     chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred~     patients with high risk of distance metastasis will be randomly divided into two groups,~     comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to~     find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of~     distance metastasis.~   "
218008|NCT00705614|"~     Prospective, observational, parallel-group, postmarketing safety surveillance registry in~     participants treated with Remicade or standard therapy for active or fistulizing Crohn's~     disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy~     group may switch over to Remicade any time during the follow-up period~   "
218009|NCT00705601|"~     To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in~     subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning~     refreshment and uncovering problems in instrument administration in subjects with~     nonrestorative sleep~   "
218010|NCT00705588|"~     Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in~     constriction and high pressures. Treatment is given with a variety of drugs including the~     prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors~     (e.g. sildenafil).~      Although these drugs are known to be effective alone, little is known about combining them~     together in various combinations.~      In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with~     pulmonary arterial hypertension who currently are receiving only a prostanoid drug.~   "
218011|NCT00705575|"~     This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy~     to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients~     with Stage II hypertension over a period of 12 weeks.~   "
218012|NCT00705562|"~     The objective of the study is to assess comparative gastrointestinal tolerance of normal term~     infants to various milk-protein infant formulas.~   "
218013|NCT00705549|"~     This is a prospective pilot phase II trial, in patients with wet stage IIIb and IV NSCLC~     using chemotherapy regimens which will be defined according to the pharmacogenomic profile~     (tumoral expression of ERCC1, BRCA1 and RRM1) of the tumor cells.~   "
218014|NCT00705536|"~     The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of~     Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a~     single subcutaneous (SC) injection of 20 units (U) with or without coadministration of~     recombinant human hyaluronidase PH20 (rHuPH20).~      The study hypothesizes that the time required to reach maximum insulin concentration (tmax)~     when insulin is administered with rHuPH20 will be comparable or shorter than the time~     required without rHuPH20.~   "
218015|NCT00705523|"~     The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the~     treatment of alcohol dependence.~   "
218016|NCT00705510|"~     To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan)~     versus an artificial tears alone in patients with meibomian gland dysfunction that have~     abnormal tear quality and quantity by subjective symptoms and signs including tear breakup~     time~   "
218017|NCT00705497|"~     Background: This prospective study was designed to be the first to evaluate the toxicity of~     radiofrequency ablation (RFA) in patients with recurrent pediatric solid tumors.~      Methods: From 2003 through 2006, we conducted a phase I, IRB-approved study of RFA for~     recurrent solid tumors. A multidisciplinary cancer management team selected appropriate~     candidates for the study. Imaging-guided RFA was performed percutaneously. Response was~     assessed at 3 months. Repeat RFA was performed for some incompletely ablated or new lesions.~   "
218018|NCT00705484|"~     This is a prospective, safety surveillance registry in subjects with moderate-to-severe~     active ulcerative colitis (UC).~   "
218019|NCT00705471|"~     A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will~     capture data to measure health care resource utilization associated with the use of~     Infliximab for treatment of CD. Three health science centres/hospitals from Ontario are~     targeted to participate in the study, each site is expected to provide 30-40 patient charts~     with a target of 108 charts total.~   "
218020|NCT00705458|"~     The purpose of this study is to determine whether coronary artery CT scanning or nuclear~     stress testing is better at diagnosing chest pain patients with coronary artery disease to~     select appropriate candidates for coronary catheterization and re-vascularization.~   "
218021|NCT00705445|"~     Information on the mechanisms of zinc is still in developing phase. Ecological and biological~     implications of long term zinc supplementation at population level requires assessment. The~     trial aims to assess the impact of routine supplementation of zinc among young growing~     children and evaluate its impact on intestinal microbial flora and relationship with gut~     mucosa integrity and co-morbidities.~   "
218022|NCT00705432|"~     This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG)~     + Ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult participants with~     chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active~     anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy~     with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy~     after a 4-week lead-in period may allow for both increased rates of sustained virologic~     response (SVR) and shorter treatment durations (in some populations) than treatment with~     PegIntron plus ribavirin alone.~      The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black~     participants). Participants from each cohort are assigned (randomized) to one of three study~     arms, all of which have a 4-week lead-in period with (PEG + RBV).~   "
218023|NCT00705419|"~     Nonrandomized, prospective, observational, multi-site registry to assess long-term safety,~     clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or~     discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects~     will be followed for up to 5 years.~   "
218024|NCT00705406|"~     The purpose of this study is to determine whether peramivir is safe and effective in the~     treatment of uncomplicated seasonal influenza.~   "
218025|NCT00705380|"~     This study will evaluate the effectiveness of cognitive behavioral therapy with a panic~     control treatment component in treating adolescents with panic disorder.~   "
218026|NCT00705367|"~     The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via~     intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in~     mainland Chinese subjects with systemic lupus erythematosus (SLE)~   "
218027|NCT00705354|"~     This study will compare the incidence of post-op infection after sinus surgery using~     conventional post-op oral antibiotics to the incidence of infection after sinus surgery when~     a bio-resorbable antibiotic soaked nasal sponge is used in the nasal cavity in lieu of~     post-op oral antibiotics. The nasal sponge is a routine nasal dressing used after sinus~     surgery and will therefore be placed in all patients.~   "
218028|NCT00705341|"~     The purpose of this research is to evaluate the methacholine challenge test as an accurate~     indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares~     methacholine challenge test results from asthma patients to those from people who do not have~     asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid~     will be compared to results on high dose inhaled corticosteroids. Both males and females with~     stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will~     be between 12 and 69 years of age.~   "
218029|NCT00705328|"~     This study is designed to provide clear evidence for health and social policymakers about the~     influence of alternate service-delivery models and practices on enhancing and sustaining~     low-income family linkages to available services. A challenge faced by Canadian health and~     social service providers is to promote health for low-income families in a proactive and~     cost-effective manner. Families with low incomes experience an array of health and social~     barriers that compromise their resilience, lead to negative family outcomes, and act as~     barriers to available services. Family barriers are compounded by service delivery barriers~     and result in reduced opportunities for effective, primary-level services and in increased~     use of secondary-level services (e.g., emergency room visits, emergency intervention, police~     involvement), with the obvious increase in costs. Randomized-controlled trials are rare in~     community-based intervention research.~      This Families First Edmonton randomized-controlled trial (RCT) will enable testing of~     innovative service-delivery models and provide an opportunity for evidence-based decision~     making for Canadian policy makers. Critical information will be provided about~        1. optimizing cost effectiveness for public systems~        2. the long-term effects on the health of low-income family members~        3. mechanisms that intervene between the interventions and their effect on the health of~          low-income family members~        4. building on previous research and on community-based initiatives~        5. promoting knowledge transfer~   "
218030|NCT00705315|"~     This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus~     bevacizumab as first line treatment in patients with metastatic and HER2 negative breast~     cancer.~   "
218031|NCT00705302|"~     The aim of this study is to determine the long term effect of a self-help group in a patient~     education program for patients with chronic obstructive pulmonary disease (COPD).~   "
218032|NCT00705289|"~     This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA)~     who are being treated with infliximab for the first time, in order to learn about their~     disease characteristics. Patients in this study will be treated for RA with infliximab and in~     a usual manner as decided by their physician.~   "
218033|NCT00705276|"~     To prove the absence of photo irritation and photo sensitivity potential of the product~     Dermacyd Femina Delicata.~   "
218034|NCT00705263|"~     The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus~     ribavirin. Drug administration accuracy and ease of use will definitely determine treatment~     effectiveness. This is the idea behind the development and usage of the PegIntron pen~     (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel~     device. The results of the study will be used to improve PegPen training techniques for~     patients and health care providers.~   "
218035|NCT00705250|"~     The standard treatment for patients with HL that has not responded to treatment or has come~     back after treatment is stem cell transplant. When patients are not eligible for transplant~     or when HL comes back after transplant, there are no standard treatment options. These~     patients can receive chemotherapy or participate in clinical trials. Bendamustine HCl is a~     chemotherapy agent that is effective in treating patients with various diseases, including~     non-Hodgkin's lymphoma, multiple myeloma, and breast cancer. It was recently approved for the~     treatment of chronic lymphocytic leukemia. In addition, small studies from Eastern Europe~     have shown that bendamustine HCl is likely effective for treating HL. This study will find~     out the effect of bendamustine HCl for transplant-ineligible patients with HL that has not~     responded to or has come back after treatment.~   "
218036|NCT00705237|"~     This pilot study will evaluate the accuracy and ease of use of the LUMA light wire and~     whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon~     dilation procedures.~   "
218037|NCT00705224|"~     Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard~     treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice~     in Russia. The objective of this study is to examine the influence of insulin resistance on~     the safety and efficacy of treatment with pegylated interferon and ribavirin and to determine~     the prevalence of insulin resistance in different populations of CHC patients.~   "
218038|NCT00705211|"~     This study is a non-interventional (observational) study in Japan to confirm the safety and~     efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs~     in daily medical practice throughout a 52-week period. It is being conducted as a~     post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's~     guideline on Good Post-marketing Study Practice.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
218039|NCT00705198|"~     The purpose of this study is to confirm the safety and efficacy of temozolomide in patients~     with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy)~     and relapsed malignant glioma (as monotherapy) when used in the daily medical practices.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
218040|NCT00705185|"~     The purpose of this study is to develop a blood test for major depression and measure the~     effects of ziprasidone monotherapy on these markers.~      Specific Aim: Using a multiplex biomarker assay we will measure levels of 16 biomarkers in~     patients with MDD enrolled in this ancillary study (adjunct to study NCT00555997) and compare~     these results to those of healthy controls (defined as research subjects who have not met~     criteria for any lifetime Axis-I disorder (DSM-IV)) from an existing dataset at PHB.~   "
218041|NCT00705172|"~     This study is conducted in Europe. The aim of this observational study is to collect data~     from children with Prader-Willi Syndrome, who have been treated off-label with Norditropin®~     for more than 12 months to seek approval for Norditropin® treatment with Prader-Willi~     Syndrome.~   "
218042|NCT00705159|"~     The objective of this study is to evaluate the safety and effectiveness of Zylet in~     comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of~     blepharoconjunctivitis in pediatric subjects.~   "
218043|NCT00705146|"~     Osteoarthritis (OA) of the thumb carpometacarpal (CMC) joint is a common condition that is~     seen regularly in outpatient occupational therapy and physiotherapy departments. Prevalence~     rates of symptomatic thumb OA have been found to be as high as 25%. The conservative~     treatment of choice consists of splinting. There are many different types of thumb splints~     available, but no specific guidelines as to which is preferred. There is limited evidence to~     support the benefits of splinting.~      The purpose of this study is to compare the effectiveness of two different thumb splints: the~     Comfort Cool, a prefabricated neoprene splint and a custom made neoprene and thermoplastic~     thumb splint. These are two of the most commonly prescribed splints in local occupational~     therapy departments.~   "
218044|NCT00705133|"~     Our hypothesis is that IV or SQ Treprostinil can improve 6 minute walk distance, hemodynamics~     and quality of life in patients with interstitial lung disease and severe secondary pulmonary~     arterial hypertension.~   "
218045|NCT00705120|"~     This protocol was a prospective, Phase I study of allogeneic bone marrow transplantation~     (BMT) as the primary therapy for Osteogenesis Imperfecta Types II and III. Compatible sibling~     donors and unrelated donors were stratified and analyzed according to the type of donor. All~     patients with a sibling donor will received a chemotherapy conditioning regimen; a non-T cell~     depleted allogeneic marrow, and GVHD prophylaxis. All patients with an unrelated donor will~     receive a chemoradiotherapy conditioning regimen, a T-cell depleted allogeneic marrow, and~     GVHD prophylaxis. The primary objective of this study was to investigate the safety and~     toxicity of these BMT procedures in this particular population.~   "
218079|NCT00704639|"~     This is a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with~     Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin.~      The aim of this study is to show the feasibility and safety profile of the combination of~     cetuximab, carboplatin and RT in treatment of patients with LAHNC.~   "
218046|NCT00705107|"~     Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance~     of achieving a sustained virologic response in patients with hepatitis C. The objective of~     this study is to evaluate the proportion of patients who complete treatment with PegIntron~     pen and Rebetol while participating in a patient assistance program. The patient assistance~     program can consist of prophylactic treatment (eg, with growth factors, psychiatric~     medications) or other interventions (eg, psychotherapy, patient support groups, visiting~     nurse, nurse telephone calls, educational literature).~   "
218047|NCT00705094|"~     For many years, researchers and doctors have studied different kinds of treatments to improve~     the survival of men with testicular cancer. However, recent research has shown that many~     years later, men who had testicular cancer appear to be at higher risk for developing heart~     disease (heart attack or heart failure), especially if they received chemotherapy. Since~     these studies were done many years after men received treatment, there was no way to know if~     other factors contributed to the health problems they experienced. This study is being done~     because it would be helpful to study heart function and cardiovascular disease risk factors~     of men who have been diagnosed with testicular cancer, before and after they receive~     chemotherapy treatment compared to men who receive treatment with surgery alone.~   "
218048|NCT00705081|"~     The purpose of this study is to evaluate the safety and tolerability of the low-density~     lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe~     co-administered with a statin in routine daily practice. In addition, the study will~     investigate whether and to what extent the target levels set by the participating doctors are~     achieved by the co-administration therapy.~   "
218049|NCT00705055|"~     The hypothesis to be tested: After the construction of a database of anthropometric~     measurements, the system would extract important features of a given facial surface and be~     able to match it with existing morphometric figures. A given combination of normal and~     abnormal measurements will open a probable diagnosis and a list of differential diagnosis~     that will be expressed as percent of matching in a descendent order to the examiner.~   "
218050|NCT00705042|"~     The purpose of this study is to evaluate the Pharmacokinetics (PK) and safety and~     tolerability of etanercept, 25 and 50 mg, administered as a single dose to healthy male~     Chinese subjects.~   "
218051|NCT00705016|"~     The purpose of this open-label, randomized, controlled, Phase 1/2 study of the integrin~     inhibitor cilengitide is to evaluate the safety and efficacy of the combination of different~     regimens of cilengitide added to cisplatin, 5-fluorouracil (5-FU), and cetuximab in~     participants with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).~      The Phase 1 part was conducted in dedicated study centers. In the Phase 2 part of this trial,~     cilengitide is administered at two different doses to two experimental groups. The third~     group will only receive cisplatin, 5-FU and cetuximab. In the Phase 1 part of this trial, the~     dose of cilengitide in combination with cisplatin, 5-FU and cetuximab was determined.~      Cilengitide is an experimental anti-cancer substance interacting with so-called integrins.~     Integrins are protein molecules that are known to be present on the surface of certain cancer~     cells. Integrins are also found on certain cells that belong to growing blood vessels~     (endothelial cells). Integrins potentially facilitate the blood vessels' support of the tumor~     (angiogenesis) as well as the tumor's growth and further spread throughout the body~     (metastasis). By inhibiting integrins on the tumor cell surface, cilengitide potentially~     kills cancer cells, and potentially sensitizes cancer cells to other co-administered~     therapeutics. By inhibiting integrins on the endothelial cell surface, it potentially~     inhibits the ingrowth of additional blood vessels towards the tumor.~      Cilengitide is given as an intravenous infusion (given by a drip in one vein of your arm). If~     any unacceptable side effect occurs, treatment with the study drug will be stopped.~   "
218052|NCT00705003|"~     The primary objective of this study are to evaluate the synergistic effect of a combination~     product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing~     symptoms of depression in patients with Major Depressive Disorder.~      The safety and tolerability of the combination product will also be evaluated as measured by~     adverse events and vital signs.~   "
218053|NCT00704990|"~     Attention deficit/hyperactivity disorder (ADHD) is a chronic neurobehavioural disorder often~     diagnosed in childhood years. Complementary/alternative treatments including natural health~     products (NHPs) are used by children with ADHD despite limited information on their safety or~     usefulness. Some evidence suggests children with ADHD have a greater need for zinc,~     magnesium, vitamin B6 and vitamin C. This study will supplement a small number of children~     diagnosed with ADHD with therapeutic levels of these nutrients over 10 weeks to get a better~     understanding of the safety and possible benefit of using these nutrients to treat symptoms~     associated with ADHD.~   "
218054|NCT00704977|"~     Purpose of this study is to evaluate efficiency and safety of Alcohol 20% for peeling~     pterygium and to compare 3 different methods of operative wound closure: Bare sclera, Sliding~     flap, Amniotic membrane + biological glue~   "
218055|NCT00704964|"~     The objective of this study is to assess the impact of participant care and support on~     treatment adherence. PegIntron pen and Rebetol will be administered to participants with~     Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as~     providing high vs low level of participant management based on information about the level of~     participant support and management captured on the site questionnaire. Data on each~     participant will be collected by a physician on an electronic participant case report form~     (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed~     based on the high vs low level of participant management.~      The hypothesis is that Physicians investing more time and effort into participant management~     achieve higher treatment completion rates among their hepatitis C patients than physicians~     offering less participant management measures.~   "
218056|NCT00704951|"~     The purpose of this program is to determine the frequency of the use of Posaconazole in~     immunocompromised patients refractory to first line therapy receiving therapeutic treatment~     based on different pathogens in comparison to other antifungal therapy.~      A further objective is to determine the frequency of the use of Posaconazole in~     immunocompromised patients receiving prophylactic treatment in comparison to other antifungal~     prophylaxis.~   "
218486|NCT00699296|"~     This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese~     adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma.~     LBH589 is administered orally once a day for three days per week.~   "
218057|NCT00704938|"~     RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and~     stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor~     cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the~     body build an effective immune response to kill tumor cells. Giving gene-modified lymphocytes~     together with high-dose aldesleukin and vaccine therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gene-modified lymphocytes together~     with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or~     recurrent metastatic cancer.~   "
218058|NCT00704925|"~     A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for~     treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS). This is an expanded~     access trial, which means that although data from this study will be collected and reported~     to the US Food and Drug Administration (FDA)and the drug manufacturer, this is not a formal~     study of drug in LEMS.~      If you decide volunteer, you will be evaluated by a neurologist to determine your eligibility~     to receive 3, 4-DAP by a review of your medical history, medication regimen (the medications~     you are taking) and a neurological examination. If you are a female of child-bearing~     potential, a serum pregnancy test will be done to ensure that you are not pregnant. Once it~     is determined that this treatment is appropriate for your care, you will begin taking 3, 4~     DAP by mouth in slowly increasing doses. Treatment will begin with 5mg three times a day, as~     clinically needed, and if tolerated. You will be monitored for strength and side effects by~     routine clinic visits at initial intervals of once a month, increasing to intervals of every~     12 months as permitted. Blood will be drawn (approximately 1 tablespoon) at every clinic~     visit or as often as the investigator deems necessary to assess your liver/kidney function~     and blood counts. You will have an EKG (a test to see how your heart is functioning) at your~     first study visit, after 6 months of taking 3,4 DAP and again every 2 years. Treatment will~     be continued indefinitely if a good clinical response is achieved. This study is planned to~     last indefinitely.~      The dosage of 3, 4DAP is individually adjusted. The usual range is 10-15 mg 3-4 times per day~     for the full effect and will increase by 50% every two weeks to 10-15 mg three to six times a~     day, as needed and if tolerated. Dosages above the full effect level will not provide an~     additional benefit and should not be used. 3, 4 DAP is a convulsant (causes seizures). A~     total of 100 mg/day is the maximum dosage allowed.~   "
218059|NCT00704912|"~     The goal of this three-armed randomized controlled trial is to establish the relative roles~     of treatment of hyperandrogenism versus obesity (as the largest modifiable factor~     contributing to insulin resistance) in treating infertility and improving pregnancy outcomes~     among obese PCOS women. The investigators hypothesize that the key to restoring ovulation~     leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the~     key to avoiding later pregnancy complications is to improve insulin sensitivity with weight~     loss.~   "
218060|NCT00704899|"~     To compare the efficacy of physiotherapy and anti-depressants in disability reduction in~     patients of Fibromyalgia syndrome.~   "
218061|NCT00704886|"~     BACKGROUND: Advance care planning (ACP) is the process in which patients plan for future~     medical care under circumstances of impaired decision-making. Video is an underutilized~     medium that can assist clinicians in discussions of future health states, such as the state~     of advanced dementia. Video may enable patients to visualize the future by concisely~     providing complex information vital for ACP. This study will examine whether the use of video~     could facilitate a more comprehensive understanding of advanced dementia and inform~     clinician-patient discussions about the level of care a patient would want in the event of~     advanced dementia.~      RESEARCH PLAN: We propose to conduct a randomized trial studying ACP for 200 elderly subjects~     using a video depiction of a patient with dementia compared to the traditional verbal~     narrative. Specific aims 1 and 2 assess the effect of a video of advanced dementia on the~     clinical decision making of elderly subjects compared to the traditional verbal narrative.~   "
218062|NCT00704860|"~     Reduction of volume of the hippocampus has been associated with major depression in many~     studies. It has been suggested that antidepressants may protect against hippocampus volume~     loss in humans associated with multiple episodes of depression and may also reverse the~     reduction of volume caused by the depression. In addition, genetic markers for serotonin are~     implicated with depression, and may be an indication of reduced response to antidepressant~     treatments.~      This study aims to enroll patients who are defined as having treatment resistant depression~     (no remission after at least 2 treatments trials with an antidepressant). They will receive~     an MRI scan at the initial visit and either 6 months after sustained remission or 12 months~     after they enter the study for non-remitters. They will also be asked to give a blood sample~     for genotyping. They will be matched by age and handedness to healthy volunteers with no~     personal history of depression who will also receive an MRI scan and genotyping.~      The first aim is to compare hippocampal volume of depressed subjects to healthy controls. It~     is anticipated that subjects will initially have smaller hippocampal volume but of those who~     sustain remission, there will be a small increase in hippocampal volume. It is also~     anticipated that specific genetic markers will be related to individuals response to~     antidepressant treatments.~   "
218063|NCT00704847|"~     The purpose of this phase III study is to Evaluate the Efficacy and Safety of Oral Salmon~     Calcitonin in the Treatment of Patients with Osteoarthritis of the Knee~   "
218064|NCT00704834|"~     The purpose of this study is to test differences in RNA levels between Multiple Sclerosis~     (MS) patients and normal subjects. RNA provides a message from genes altered in diseases.~     We will also test DNA to determine if there are any small mutations called SNPs in any of the~     genes. The last tests are two separate tests for markers of inflammation called cytokines and~     eicosanoids. This research may lead to the discovery of biological markers for MS that are~     useful for diagnosis and treatment.~   "
218065|NCT00704821|"~     Formation of new blood vessels (angiogenesis) is important for tumor growth in advanced~     cancer. It is known that tumors make a protein called vascular endothelial growth factor~     (VEGF). VEGF stimulates the formation of blood vessels that supply the tumor with nutrients~     and oxygen. PTC299 is an oral investigational new drug that has been shown to decrease~     production of VEGF in animal models of human cancer. In these animal models, oral PTC299~     administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood~     vessel numbers in the tumor, and significantly slows or halts tumor growth. When given in~     combination with the chemotherapeutic drug, docetaxel, PTC299 increases the antitumor~     activity over use of docetaxel alone. Safety studies in research animals indicate good~     tolerability at doses and drug levels that are higher than those planned for the clinical~     studies. Results from Phase 1a studies in healthy volunteers indicate that PTC299 achieves~     levels of PTC299 in the bloodstream that are known to be active in animal models of human~     cancer. This Phase 1b study is designed to test the hypothesis that PTC299 will be tolerable~     and will show evidence of anti-VEGF and antitumor activity when administered orally to~     patients with cancer.~   "
218067|NCT00704795|"~     In order to evaluate the potential role of the gastrointestinal (GI) tract in the~     postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well~     as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in~     patients with T1DM without residual beta-cell function during 50-g oral glucose tolerance~     test (OGTT) and during isoglycemic iv glucose infusion. By evaluating C-peptide negative~     patients with T1DM we aim to describe the glucagon response to glucose (+/-stimulation of the~     GI tract) independently of the potentially very important regulation of glucagon secretion by~     endogenous insulin secretion. A more detailed understanding of the inappropriate glucagon~     secretion in T1DM is highly needed in order to establish new intervention strategies in the~     future treatment of the growing numbers of T1DM patients.~   "
218068|NCT00704782|"~     The purpose of this study is to assess the safety and efficacy of Dimebon in combination with~     donepezil (Aricept) in the treatment of Alzheimer's disease.~   "
218069|NCT00704769|"~     Evaluate the safety and general clinical response of desloratadine syrup in the relief of~     symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.~   "
218070|NCT00704756|"~     This is an observational study of patients undergoing treatment with PegIntron and Rebetol~     for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered~     as part of the study. Safety parameters will be assessed retrospectively. Efficacy~     parameters, such as relapse rates and sustained virologic response rates, will be assessed~     prospectively. The objective of the study is to examine any associations between safety,~     virologic, histologic, demographic parameters and patient outcome (relapse rates and~     sustained virologic response rates).~   "
218071|NCT00704743|"~     Displaced fractures of the distal radius requiring closed reduction (otherwise known as~     Colles fractures) are common in the emergency department. The purpose of the study is to~     determine if there is any difference between 3 methods of immobilization for these fractures:~     circumferential cast, volar-dorsal splint, and modified sugar tong splint. Maintenance of~     position was assessed at 4 weeks after the injury and wrist strength and function were~     assessed at 2 months and 6 months. We hypothesize that there will not be a clinically~     important difference between these methods of immobilizing for displaced fractures of the~     distal radius requiring closed reduction.~      Extended description of the protocol, including information not already contained in other~     fields.~      Objectives:~      Primary: To determine the effectiveness of three immobilization methods (circumferential cast~     [CC], volar dorsal splint [VDS], modified sugar-tong [MST] splint) in maintaining the~     position of displaced distal radius fractures after successful closed reduction.~      Secondary to assess long term functional outcomes associated with fiberglass splint~     immobilization versus standard cylindrical casting in patients maintaining initial~     non-operative reductions.~      Design: Randomized prospective single blind controlled trial Patients/Participants: Patients~     over 18 years of age who presented to the emergency department with a displaced fracture of~     the distal radius, requiring closed reduction.~      Outcome Measurements: Loss of reduction (radiological slippage or the need for surgical~     fixation during the 3-4 week primary immobilization period after initial successful~     reduction). Secondary outcomes were DASH score, return to work, activities of daily living~     (ADL), wrist pain, range of motion (ROM) and grip strength.~      Study Phase Phase 3 Study Type Interventional - Assigned to treatment Recruitment status~     Completed 2003 Record Verification Date March 2003 Anticipated trial start date November 1998~     Last Follow-Up Date December 2002 Data Entry Closure Date January 2004 Study Completion Date~     July 2004 Purpose Treatment Allocation Randomized~      Masking Single Blind Control Active Assignment Parallel Endpoints Efficacy Primary outcome~     Radiologic slippage of fracture at 4 weeks post reduction~      Key secondary outcomes Functional outcomes: DASH score, return to work, activities of daily~     living (ADL), wrist pain, range of motion (ROM) and grip strength~   "
218072|NCT00704730|"~     The purpose of this research study is to evaluate the progression-free survival (PFS) with~     XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally~     advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to~     receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits~     VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.~      The Clinical Steering Committee for this study, comprised of study doctors who specialize in~     medullary thyroid cancer, has provided guidance regarding the design of the study. The~     committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven~     Sherman, MD.~   "
218073|NCT00704717|"~     The objective of this study is to evaluate patient satisfaction in hepatitis C patients~     receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is~     correlated with adherence to the prescribed regimen which, in turn, is affected by the ease~     of use and accuracy of treatment administration. Since the PegIntron pen is a novel device,~     the results of this study will be used to improve the training of patients and healthcare~     providers in PegIntron pen use.~   "
218074|NCT00704704|"~     Study Objectives The aim of the study is to evaluate the safety and efficacy of the~     combination of 5-Aza-Cytidine + Thalidomide on the course of hrMDS patients.~      Primary end point:~      • To evaluate the overall response rate (CR+PR) of the combination of 5-Aza-Cytidine +~     Thalidomide in hrMDS patients (INT-2 and High risk as defined by IPSS).~      Secondary end points:~        -  To evaluate the safety of the combination of Thalidomide+5-Aza-Cytidine in high risk MDS~          patients.~        -  Hematological improvement rate.~        -  Cytogenetic response.~        -  Progression free survival (PFS).~        -  Quality of life assessment (FACT: MDS and peripheral neuropathy QOL Questionnaires).~      Study design:~      This is a multicenter, phase II, single arm study designed to evaluate the safety and~     efficacy of the combination of Thalidomide+5-Aza-Cytidine in high risk MDS patients (INT-2~     and High risk defined by IPSS) who are older than 18 years of age. Potential study subjects~     will sign an informed consent prior to undergoing any study related procedure. Number of~     patients to be enrolled 50.~      Treatment plan: 5-aza-cytidine (75 mg m2/d) will be injected subcutaneously in 5-day cycle~     every 28 days, for a total of 12 cycles.~      Thalidomide will be given at the dose of 50 mg/d, from day 1 until for 6 months together with~     5-aza-cytidine .~      Treatment period includes 5-aza-cytidine (75 mg m2/d) will be injected subcutaneously in~     5-day cycle every 28 days. Total number of 12 cycles or until progression or toxicity. Cycle~     delay of maximum 2 weeks in case of hematological toxicity grade 3-4 at investigator~     discretion.~      Duration of the follow up period is 6 months. Duration of study The duration of the treatment~     period is approximately 12 months. This time is required to complete the treatment, and to~     determine the safety profile and the response rate. The duration of the Follow period will be~     approximately a half year. The occurrence of PD will determine the duration of~     progression-free survival of each patient.~   "
218075|NCT00704691|"~     The purpose of this study is to:~        -  assess the effectiveness of lenalidomide for the treatment of patients with relapsed and~          or refractory peripheral T-cell lymphomas; and,~        -  assess the safety of lenalidomide.~      There are reports suggesting a therapeutic benefit of thalidomide in patients with refractory~     and/or relapsed Non-Hodgkin's Lymphoma's (NHL) which have led to the formal investigation of~     lenalidomide in the treatment of relapsed NHL's.~   "
218076|NCT00704678|"~     This study will determine the titration regimen for SBR759 compared to sevelamer HCl in~     lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis~   "
218077|NCT00704665|"~     Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It~     has ani-fibrotic properties. Previous studies have shown that relaxin is safe at~     concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if~     skin improvement and improvement in functional ability can be achieved.~   "
218078|NCT00704652|"~     The purpose of this study is to determine whether systemic administration of darbepoetin~     alpha results in the progression or regression of diabetic macular edema.~   "
233635|NCT00497939|"~     The purpose of this study is to assess the effect of saw palmetto and sanmiaoshan, on top of~     alpha blocker, on urinary flow rate and BPH symptoms in patients with BPH.~   "
218080|NCT00704626|"~     Under normal conditions our immune system protects us against infections and tumors. The~     immune system does this by recognizing that the infecting organism or the tumor is foreign to~     the body and attacking it. One way the immune system attacks a foreign target is by making~     proteins called antibodies that bind to the target. Sometimes, for reasons we poorly~     understand, the immune system wrongly identifies part of our own body as being foreign and~     attacks it. This can result in disease such as some forms of diabetes and thyroid disease, as~     well as some neurological diseases. In this study, one tablespoon of blood will be removed~     from each subject and tested to see if the immune system is making antibodies against~     components of the nerves and muscles. We also hope to learn if these antibodies contribute to~     the development or worsening of illnesses of the nervous system. Only one blood draw is~     required, but subjects may be asked to give up to 8 additional blood samples to see if the~     level of antibodies changes over time. Any additional blood draws would be performed at~     regularly scheduled clinic visits. There would be at least 3 months between blood draws over~     a period of up to 3 years, if requested by the physician.~      Depending on your diagnosis, the physician may also request the collection of mouth (buccal)~     cells. This takes about one minute and is painless. The cells are collected by swishing a~     swab around your mouth. This cheek swab would be done with each blood draw.~      Please note that this study is conducted ONLY at UC Davis and that all participants must be~     seen in our clinic located in Sacramento, CA. Results of the testing performed in this study~     are not given to the participants. This study is not intended to treat or diagnose any~     condition.~   "
218081|NCT00704613|"~     The planning target volume (PTV) and planning organ at risk volume (PRV) margins used for~     pediatric radiation therapy are empiric, and quantitative assessment of these margins is~     needed to improve therapy planning and delivery.~   "
218082|NCT00704600|"~     The aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy~     in patients with locally advanced rectal cancer. Furthermore analysis of the effect of~     nelfinavir combined with chemoradiation on tumour tissue will be studied~   "
218083|NCT00704587|"~     The purpose of this study is to investigate every possible applicability of flow cytometrical~     analysis in the intracellular detection of tumor-related material in activated macrophages in~     the broadest range of cancer types.~   "
218084|NCT00704574|"~     This observational study is conducted in Europe. The trial aims to observe the incidence of~     serious adverse drug reactions in children and adolescents with type 1 diabetes during~     Levemir® treatment.~   "
218085|NCT00704561|"~     The objective of this study is to evaluate the completeness of struts coverage and vessel~     wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR~     drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform)~     implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction~     (STEMI). To investigate the completeness of the coverage as well as the number of uncovered~     stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high~     resolution (~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.~   "
218086|NCT00704548|"~     Few trials have investigated the hypotensive effect of the Statins. Most were not~     specifically aimed at this pleiotropic effect or had methodological problems. The possible~     hypotensive effect may explain part of the favorable results of the Statins use on~     cardiovascular prevention independently from its action on the cholesterol profile.~      The purpose of this study is to determine the effect of Simvastatin on the blood pressure~   "
218087|NCT00704535|"~     The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of~     Ezetimibe when used alone or in combination with a statin in patients with~     hypercholesterolemia~   "
218088|NCT00704522|"~     Patients receiving a patient assistance program during therapy for Hepatitis C will be~     enrolled into this study. All patients will receive PegIntron pen and Rebetol according to~     label and the patient assistance program. This study will be compared to similar studies from~     other clinics using various patient support programs for the purpose of designing future~     comparative phase IV studies.~   "
218089|NCT00704509|"~     The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance~     phase of schizophrenia compared to placebo.~   "
218090|NCT00704496|"~     The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a~     decongestant, will decrease nasal congestion leading to increased patency of the nose and a~     decrease in nighttime sleep fragmentation in individuals with year round perennial allergic~     rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and~     fatigue.~   "
218091|NCT00704483|"~     This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum~     phosphate levels in Chronic Kidney Disease patients on hemodialysis~   "
218092|NCT00704470|"~     In Intensive Care Medicine, critical incidents are not rare and may result in fatal outcome.~     High fidelity patient simulators are commonly used in training curricula for healthcare~     professionals especially in anesthesiology, emergency medicine, and intensive care medicine.~     Several different course concepts have previously been published. As we know from recently~     published data, up to 80% of all critical incidents in the field of medicine are caused by~     human error. The authors of the present study aimed to investigate the effects of two~     different course concepts (one addressing technical skills in intensive care medicine and on~     addressing non-technical skills) on stress and performance. Stress and performance are~     measured in a pre-intervention and a post-intervention testing scenario.~   "
218093|NCT00704457|"~     Urine will be collected and sent to the University of Maryland. Urines will be analyzed for~     urine markers.~   "
218094|NCT00704444|"~     This study is a non-interventional (observational) study in Japan to confirm the safety and~     efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs~     in daily medical practice throughout a 12-week period. It is being conducted as a~     post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's~     guideline on Good Post-marketing Study Practice.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
233784|NCT00495976|"~     Common cold medicines are often formulated as a hot drink yet there is no evidence in the~     public domain that presenting the medicine as a hot drink has any impact on symptom severity.~   "
218095|NCT00704431|"~     Subjects will receive their first dose of darapladib in the clinical research unit (CRU), and~     the remaining 9 days of dosing will occur at home. Subjects will record any adverse events~     throughout the dosing period in a paper diary. Subjects will return to the CRU 10-14 days~     after the last dose of darapladib for a follow-up visit. The total study duration for each~     subject including the screening, treatment and follow-up periods will be approximately 4~     weeks.~   "
218096|NCT00704418|"~     Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery~   "
218097|NCT00704405|"~     The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of~     Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary~     hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily~     (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC)~     participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of~     study therapy (SVR24).~   "
218098|NCT00704392|"~     The purpose of this study is to determine the safety, tolerability, and highest safe doses of~     XL647 in combination with XL147 in adults with solid tumors. XL647 is a small molecule that~     potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), and ErbB2. XL147~     is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to~     inhibit growth and induce apoptosis (programmed cell death) in tumor cells.~   "
218099|NCT00704379|"~     The purpose of this study is to examine the efficacy of sertraline to prevent the onset of~     mood and anxiety disorders during the first six months after traumatic brain injury.~   "
218100|NCT00704366|"~     This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients~     with advanced solid malignancies.~   "
218101|NCT00704353|"~     The objective of this study is to evaluate the safety of FCM in patients with anemia who are~     not dialysis dependent~   "
218102|NCT00704340|"~     DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and~     spinal procedures. This study was completed to further evaluate the safety of the DuraSeal~     Sealant in a post-approval setting as compared to control (defined as methods typically~     employed by surgeons to seal the dura).~   "
218103|NCT00704327|"~     The purpose of this study is to evaluate whether or not cerebral atrophy scores obtained from~     a brain MRI can correlate with Cognitive Test results. These results hope to demonstrate a~     link between cerebral ischemic/degenerative changes shown on the MRI and cognition functions~     results.~   "
218104|NCT00704314|"~     We aimed to address the issue whether statins affect insulin resistance. To this end, we~     combined the available state-of-the art technology for detailed assessment of both whole-body~     and tissue specific insulin sensitivity in vivo in humans (euglycemic-hyperinsulinemic clamp,~     stable isotope [6,6-2H2]glucose dilution technique, proton nuclear magnetic resonance~     spectroscopy - 1H MRS - of liver and skeletal muscle). Outcome measures were determined~     before and after 8 weeks therapy with 80 mg Simvastatin in hypercholesterolemic patients with~     type 2 diabetes.~   "
218105|NCT00704301|"~     Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to~     investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol~     shortens the duration of delirium in comparison to placebo added to the treatment with~     haloperidol.~   "
218106|NCT00704288|"~     The purpose of this study is to evaluate the objective response rate and 6-month~     progression-free survival rate of XL184 in subjects with recurrent or progressive~     glioblastoma multiforme. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET,~     kinases implicated in tumor formation, growth and migration.~   "
218107|NCT00704275|"~     To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to~     Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference~     between these two groups.~   "
218108|NCT00704262|"~     There are few therapies suitable for the treatment of psoriasis on the face and skin folds.~     As these areas are sensitive, irritation and other adverse reactions are more common than~     elsewhere on the body. The purpose of the study is to monitor the effect of once daily~     treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus~     hydrocortisone 10 mg/g on the hypothalamic-pituitary-adrenal axis and on the calcium~     metabolism in patients with psoriasis vulgaris on the face and on the intertriginous areas~   "
218109|NCT00704249|"~     This study aims to compare the trough plasma concentrations of nevirapine after 7 days of~     treatment at the full dose from baseline with dose escalation in patients taking efavirenz~     who switch to nevirapine due to neuropsychiatric adverse reactions.~   "
218110|NCT00704236|"~     The purpose of this study is to evaluate the efficacy of Traditional Chinese Treatment(TCT)~     on insulin sensitivity and other related factors in type 2 diabetes by using an double-blind,~     randomized, parallel control and prospective study This traditional compound Chinese herb~     preparation is referred to this study, with three kinds of plants: 50 mg of Coptis Chinensis,~     30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica, all of which are selected~     by The Chinese Academy of Medical Sciences among those traditionally considered effective and~     safe in the treatment of diabetes.~      Patients enrolled were randomized into TCT group and placebo group administrated with TCT and~     placebo respectively. Glucose disposal rate (GDR), fasting plasma glucose (FPG), postprandial~     plasma glucose (PPG), HbA1C and other metabolic components were assessed at baseline and end~     point~   "
218111|NCT00704223|"~     This study is conducted in Europe. The aim of this observational study is to evaluate the~     incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions~     in Austria.~   "
218112|NCT00704210|"~     Objective To demonstrate the effectiveness of a conservative treatment approach for chronic~     low back pain that addresses the underlying problem of intervertebral disc lesions and~     degenerative disc disease, namely vertebral pressure on vital structures of the lumbar~     region.~   "
218113|NCT00704197|"~     The purpose of this study is to characterize differences in the structure and function of the~     body fat from two different parts of the body in young, healthy men and women. We will also~     compare how differences in metabolism relate to characteristics of body fat and its~     functions.~   "
218640|NCT00697216|"~     This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine~     administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month~     vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.~   "
218114|NCT00704184|"~     A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered~     with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response~     (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in~     participants with chronic HCV infection. The primary hypothesis was that the proportion of~     participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater~     than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were~     co-administered with Peg-IFN/Ribavirin.~   "
218115|NCT00704171|"~     To further characterize the PleuraSeal Sealant System as compared to standard of care~     (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy and~     segmentectomy via open thoractomy.~   "
218116|NCT00704158|"~     This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally~     advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV)~     once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose~     (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally~     advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial~     to further evaluate the safety and efficacy of CR011-vcMMAE.~   "
218117|NCT00704145|"~     A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage~     and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte~     stent implantation (staged procedures) in patients with multi vessel native coronary artery~     lesions~   "
218118|NCT00704132|"~     A clinical study to determine the safety, efficacy and the way sitagliptin works in patients~     with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.~   "
218119|NCT00704119|"~     RhuDex® (code number AV1142742) is a novel, orally bioavailable, low molecular weight~     modulator of co-stimulation of T lymphocytes. RhuDex® binds to the protein CD80 (also known~     as B7-1) on the surface of antigen-presenting cells and inhibits its interaction with CD28~     (but not with CTLA-4) presented by CD4+ T lymphocytes.~      RhuDex® is being developed for the treatment of rheumatoid arthritis. To improve oral~     bioavailability, the study drug has to be co-administered with an alkaline buffer that~     increases gastric pH values. In previous in vitro and phase I studies, meglumine has been~     identified as the most effective buffer. Study CT 5002 is designed to evaluate the~     bioavailability of four increasing doses of RhuDex®, combined with a fixed amount of~     meglumine using a tablet formulation, under fed and fasted conditions as well as with~     co-administration of the proton pump inhibitor pantoprazole. Furthermore, dose/plasma~     concentration proportionality for single dosing and accumulation effects for repeat dosing of~     RhuDex® will be evaluated.~   "
218120|NCT00704106|"~     We propose a largely retrospective study with short-term prospective follow-up in a subgroup~     of patients who have not yet been treated with 48 weeks of entecavir following partial~     response to adefovir. The aim of the study is to describe sequential virologic response to~     adefovir and entecavir.~   "
218121|NCT00704093|"~     Right ventricular (RV) apical pacing induces a left bundle branch block (LBBB) type~     electrical activation sequence in the heart. This abnormal activation pattern of the~     ventricles may have detrimental effects on cardiac structure and function. RV pacing has been~     shown to impair left ventricular (LV) function both in normal and failing hearts.~     Importantly, it has been demonstrated that this deterioration in LV function is related to~     the presence of LV dyssynchrony during RV pacing.~      The exact effects of RV pacing on myocardial perfusion, oxidative metabolism and cardiac~     efficiency have not been fully elucidated. The objective of the present study is to evaluate~     the effect of RV pacing on both global and regional oxidative metabolism and perfusion, and~     myocardial efficiency. In addition, the effect of RV pacing induced LV dyssynchrony on~     myocardial oxidative metabolism and efficiency will be studied.~      Our hypothesis is that LV dyssynchrony during RV pacing results in regional abnormalities in~     LV perfusion and oxidative metabolism. LV dyssynchrony will also result in altered myocardial~     efficiency.~   "
218122|NCT00704080|"~     The purpose of this study is to determine the safety and tolerability of XL765 in combination~     with Temozolomide in adults with anaplastic gliomas or glioblastoma on a stable Temozolomide~     maintenance dose. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In~     preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce~     apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown~     to inhibit the growth of tumor cells. Temozolomide (TMZ, Temodar®) is an orally administered~     alkylating agent with activity against malignant gliomas. It is approved by the Food and Drug~     Administration for the following indications: 1) treatment of newly diagnosed glioblastoma~     multiforme (GBM) patients when given concomitantly with radiotherapy and then as maintenance~     treatment; 2) refractory anaplastic astrocytoma (AA), ie, patients who have experienced~     disease progression on a drug regimen containing nitrosourea and procarbazine. Temozolomide~     is commonly used in the treatment of other anaplastic gliomas (AG) including oligodendroglial~     tumors and mixed gliomas.~   "
218123|NCT00704067|"~     The 12-month study will investigate a cognitive training augmentation of supported employment~     to improve cognitive performance and work outcomes, which are expected to result in improved~     quality of life and community integration for veterans with mild to moderate traumatic brain~     injuries. The primary hypothesis is that compared to veterans who receive enhanced supported~     employment, those who receive supported employment plus cognitive training will work more~     weeks during the 12 months.~   "
218124|NCT00704054|"~     Ridaforolimus (Deforolimus, AP23573, MK-8669) is an mTor inhibitor shown to have promising~     activity in adults with a variety of solid malignancies, particularly the sarcomas. To date,~     no studies to evaluate appropriate dosing or to obtain pharmacokinetic data in pediatric~     patients have been conducted. Sarcomas are the second most common solid malignancies in~     children and young adults, and for those patients with recurrent or refractory disease, new~     therapies are needed. This initial evaluation of ridaforolimus will help define appropriate~     dosing and toxicity evaluations, as well as establish the first pharmacokinetic and biologic~     correlative data in pediatric patients treated with ridaforolimus.~   "
218125|NCT00704028|"~     The objective of this study is to evaluate the safety of FCM in patients with anemia who are~     not dialysis dependent.~   "
221118|NCT00664521|"~     The primary objective of this study is to assess the safety and tolerability of combined~     treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA)~     receiving re-treatment with rituximab.~   "
218126|NCT00704015|"~     The purpose of this study was to evaluate if an intervention with smoking cessation starting~     during the acute hospitalization period and continuing during the acute postoperative phase~     of 6 weeks would reduce the frequency of overall postoperative complications and wound~     infections in patients with acute musculoskeletal injuries requiring surgical treatment. The~     secondary aims were to study the short and the long term (1 year) abstinence rate, functional~     outcome, health related quality of life as well as costs.~   "
218127|NCT00704002|"~     This is a prospective, randomized, multi-center pilot study of isolated, displaced neck~     fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with~     antegrade intramedullary splinting or conservative treatment.~   "
218128|NCT00703989|"~     Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental~     diabetic retinopathy and incipient nephropathy in these models. In cultured vascular cells,~     it also reduces aldose reductase gene expression, activity, and sorbitol levels. It does so~     by activating the enzyme transketolase. α-lipoic acid, a potent antioxidant, has also been~     reported to reduce both diabetic microvascular and macrovascular complications in animal~     models. To determine whether benfotiamine in combination with α-lipoic acid would normalize~     markers of ROS-induced pathways of complications in humans, we performed a pilot study in~     subjects with Type 1 diabetes using one daily dose of benfotiamine in combination with~     α-lipoic acid.~   "
218129|NCT00703976|"~     The purpose of this study is to compare the effects (good and bad) of chemoradiotherapy with~     or without Bevacizumab (Avastin). Chemoradiotherapy is the combination of chemotherapy (the~     drugs pemetrexed and cetuximab) and radiation. Pemetrexed is not approved by the Food and~     Drug Administration (FDA) for head and neck cancer when used in combination with radiation~     therapy. Cetuximab is also approved by the FDA for head and neck cancers in patients who have~     failed other chemotherapy treatments. Bevacizumab is approved by the Food and Drug~     Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of~     chemotherapy. In this study, the use of bevacizumab is investigational.~   "
218130|NCT00703963|"~     Patients who receive a mechanical heart valve to replace a diseased heart valve must take an~     anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation.~     Until recently, the testing of the level of anticoagulation was performed at medical~     laboratories or hospitals.~      The purpose of this study is to see if patients who test their level of anticoagulation by~     themselves at home and then call their doctor with the result have better control of their~     anticoagulation as compared to patients whose anticoagulation is checked only by their~     physician.~   "
218131|NCT00703950|"~     The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking~     patterns in preterm infants. It will be a randomized blind study. One group will be~     randomized to use bottle to feed and another one to use a cup to feed. As secondary~     endpoints, weight gain, days of life to begin full oral feeding, length of hospital stay and~     breast feeding rates will be observed.~   "
218132|NCT00703937|"~     The objective of this study is to evaluate the safety of FCM in patients with anemia who are~     not dialysis dependent.~   "
218133|NCT00703924|"~     This study is to determine the effectiveness and safety of WR 279,396, a topical cream for~     the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo~     control under double-blind conditions in a local population group in Tunisia where~     leishmaniasis is endemic.~   "
218134|NCT00703911|"~     This study was conducted in Africa, Europe, the Middle-East and South America. The primary~     objective of this registry was to observe the use of single dose and multi-dose use of~     activated recombinant human factor VII and to compare short-term outcomes, including~     effectiveness, safety, quality of life and treatment satisfaction with the approved~     treatments.~   "
218135|NCT00703898|"~     Although nevirapine is used as an alternative to efavirenz for initial regimen in developed~     countries, nevirapine has still been a key antiretroviral drug in many resource-limited~     countries including Thailand due to its accessibility and affordability. In addition, a~     component of stavudine and lamivudine is still widely used as a backbone in the~     antiretroviral regimen in this setting.To date, data on the durability of a regimen of~     stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited~     settings.~   "
218136|NCT00703885|"~     The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy~     controls to examine the acute effects of certain anxiolytic medications on brain function.~   "
218137|NCT00703872|"~     A Phase II, Open Label, Multi-Center, Proof-Of-Concept Study determing whether treatment with~     HDV-Interferon (HDV-IFN), by oral or subcutaneous (injection) routes, and ribavirin results~     in similar efficacy [Rapid Virologic Response (RVR)] and safety as the reported efficacy and~     safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with~     chronic hepatitis C (treatment naïve by oral route and non-responders by SC route~     respectively).~   "
218138|NCT00703859|"~     This is a study to see whether radiotherapy plus chemotherapy (Temozolomide) plus~     Dichloroacetate (DCA) improves overall survival and offers better control of the disease in~     patients with newly diagnosed Glioblastoma Multiforme Tumours.~   "
218139|NCT00703846|"~     Extina (ketoconazole) Foam, 2% was approved for marketing in the United States (US) in June~     2007. Extina foam is indicated for topical treatment of seborrheic dermatitis in~     immunocompetent patients 12 years of age and older. The approved dosing regimen is twice~     daily for 4 weeks. The treatment of recurrent seborrheic dermatitis demands a topical~     preparation that is safe for both short-term and chronic application. This study is being~     conducted in order to obtain long-term safety data on the use of Extina (ketoconazole) Foam,~     2% in the treatment of seborrheic dermatitis.~   "
218140|NCT00703833|"~     The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety~     Disorder.~   "
218141|NCT00703820|"~     The purpose of this study is to assess the feasibility and efficacy of a novel form of~     therapy—haploidentical NK cell transplantation—in patients with standard-risk AML. In~     addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly~     diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted~     therapy and further improvements in supportive care.~   "
221177|NCT00663754|"~     This study will evaluate the effectiveness of dissonance-based eating disorder prevention~     programs in reducing body dissatisfaction among young women with body image concerns.~   "
218142|NCT00703807|"~     Endometrial cancer is the most common malignancy of the female reproductive tract. The~     majority of patients with endometrial cancer are diagnosed at an early stage and cured with~     surgery with or without adjuvant radiotherapy. However, a significant number of patients~     present with metastatic disease outside of the pelvis or develop recurrent disease after~     primary therapy.~      mTOR inhibitors have been shown to be promising agents in reducing tumor growth in vitro and~     in vivo, in several solid cancers. Inhibitors of mTOR are primarily cytostatic in cancer~     cells; combination therapy with cytotoxic chemotherapeutics and other biologic agents may~     prove to be the most advantageous use of these drugs. mTOR inhibition with a rapamycin~     analogue demonstrated in vitro antiproliferative activity on endometrial AN3 CA and HEC-1-A~     tumor cells, and this inhibition of proliferation was found to be concentration dependent.~     Topotecan is an active agent in the treatment of advanced and recurrent endometrial cancers.~   "
218143|NCT00703794|"~     The data collected in this study will be used to support International Regulatory~     submissions. The study objective is to evaluate the continued safety and efficacy of the~     AXIUM Progressive Coil System.~      This Device has been used clinically at approximately 150 Institutions under FDA 510(k)~     clearance since April 24, 2007. The device received CE authorization on June 30, 2007.~     Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.~   "
218144|NCT00703781|"~     Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery~   "
218145|NCT00703768|"~     The purpose of this study is to evaluate if there is a difference in quality of life (as~     measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for~     biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer~     depending on when ADT is initiated.~   "
218146|NCT00703755|"~     The purpose of this study was to study the effect of different combinations of fenofibrate~     and metformin on the cluster of metabolic syndrome (MetS) biochemical abnormalities, and to~     determine the dose combination allowing normalization of MetS patients.~   "
218147|NCT00703742|"~     The purpose of this study is:~        1. to find out the structural or functional effects of selective serotonin reuptake~          inhibitors (SSRI) in major depressive disorder (MDD);~        2. find special abnormalities in depression secondary to other disease, e.g., autoimmune~          disease like systemic lupus erythematosus (SLE).~        3. find the relationship between the efficacy of antidepressant and the change of~          neuroimaging in MDD~        4. to find possible predispose to MDD~        5. to explore the DNA methylation status in depression;~   "
218148|NCT00703729|"~     The purpose of this study is to evaluate and compare clinical post-operative outcomes for~     patients using active cooling and compression device and those using ice bags and elastic~     wrap after acromioplasty or arthroscopic rotator cuff repair.~   "
218149|NCT00703716|"~     The purpose of this study is to evaluate the stabilization of trochanteric fracture using a~     screw-plate TRAUMAX~   "
218150|NCT00703703|"~     This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine~     on cardiovascular parameters in healthy subjects 50 years of age and older~   "
218151|NCT00703690|"~     This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the~     effects of MK0767 on triglycerides.~   "
218152|NCT00703677|"~     The goal of this trial is to evaluate the safety and tolerability of lithium in people with~     progressive supranuclear palsy or corticobasal degeneration.~   "
218153|NCT00703664|"~     This phase II trial studies how well bortezomib and vorinostat work in treating patients with~     recurrent mantle cell lymphoma or recurrent and/or refractory diffuse large B-cell lymphoma.~     Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
218154|NCT00703651|"~     This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the~     trivalent inactivated split virion influenza vaccine when administered by intradermal route~     with that of the current pharmaceutical presentation administered by intramuscular route.~      Primary Objective:~      To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated~     split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57~     years.~      Secondary Objective:~      To evaluate the safety profile during the 21-day period following each vaccination in each~     study group~   "
218155|NCT00703638|"~     RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by~     blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving sorafenib together with pemetrexed and cisplatin may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when~     given together with pemetrexed and cisplatin in treating patients with advanced solid tumors.~   "
218171|NCT00703430|"~     Alzheimer's disease (AD), is associated with behavioral disturbances in approximately 50% of~     AD patients in Beijing. Agitation, and aggression specifically, is considered the most~     serious noncognitive symptom experienced in patients with dementia. Memantine is a recognized~     treatment for Alzheimer's disease either alone or in combination with cholinesterase~     inhibitors. Its efficacy in vascular dementia is also established. Family members continue to~     play a central role in home care for the demented elderly in China. This proposal is to~     conduct a study in Beijing, China to investigate the efficacy and safety of Memantine in the~     treatment of agitation and aggression in AD patients. In addition, this proposal aims to~     explore the impact of memantine on caregiver burden of AD patients in Chinese culture.~   "
218182|NCT00703287|"~     The investigators wish to establish on a small scale the effectiveness of adding the~     physiotherapy programme developed by Jean-Pierre Bleton to the present standard treatment for~     cervical dystonia with a view to undertaking a larger UK-wide trial looking at overall~     cost-effectiveness. Specifically, the investigators wish to establish:~        1. Whether this specific physiotherapy program for cervical dystonia improves patient~          outcomes in terms of neck position, pain, disability, and quality of life compared to~          simple physiotherapy advice?~        2. What is the minimal clinically important change in the new CDIP-58 quality of life~          measure for cervical dystonia from a patient's perspective that could then be used to~          plan a definitive trial of this technique?~        3. What are the economic implications of the specialized physiotherapy programme?~   "
218156|NCT00703625|"~     Rationale:~      The Mammalian Target of Rapamycin (mTOR) is a large polypeptide serine/threonine kinase of~     289 kDa; kinases have been shown to be important regulators of cancer cell cycle,~     proliferation, invasion, and angiogenesis, and mTOR has been shown to have a key role in the~     signaling of malignant cell growth, proliferation, differentiation, migration, and survival.~     Inhibition of mTOR would result in arrest of cell growth in the G1 phase of the cell cycle.~      Temsirolimus (CCI-779) is a soluble ester analogue of rapamycin (sirolimus) which has shown~     impressive in vitro and in vivo cytostatic activity in selectively inhibiting mTOR. In animal~     models, temsirolimus has demonstrated an impressive cytostatic effect on a wide variety of~     cancer cells. In vitro, it inhibited the growth of human T-cell leukemia, glioblastoma,~     melanoma, prostate, breast, renal cell, and pancreatic cells, all of which showed particular~     sensitivity to temsirolimus, with significant growth inhibition at concentrations of less~     that 0.01micrometers. In Phase I trials, temsirolimus has been investigated as a single agent~     on a weekly schedule as well as daily for 5 days every other week, and evidence of activity~     was observed over the entire dose range (15 - 220 mg/m2) in patients with both breast and~     renal cancer. There was no apparent relationship between exposure and clinical benefit,~     suggesting that the inhibition of mTOR may be achieved at doses well below dose levels that~     result in dose limiting toxicities. Major tumor responses were noted in Phase I trials in~     patients previously treated with lung, breast, renal as well as neuroendocrine tumors. Minor~     responses were noted in soft tissue sarcoma, endometrial, and cervical carcinoma.~      Docetaxel is a taxane analog which is active against many solid tumors including breast,~     non-small cell lung, prostate, gastric, ovarian, head and neck, and pancreatic cancers, soft~     tissue sarcoma, and melanoma. It has been shown in several Phase III studies to have~     clinically significant activity in several solid tumors.~      We propose treating patients with resistant solid malignancies with docetaxel and~     temsirolimus. In a study using human breast cancer cell lines, mTOR inhibition with rapamycin~     had a synergistic cytotoxic effect with paclitaxel. Given the novel mechanism of action of~     mTOR inhibitors and known synergistic activity of an mTOR inhibitor, rapamycin, with a~     taxane, paclitaxel, in vitro, we envision that this regimen would be highly active in~     patients with solid tumor malignancies.~      Objectives:~      Primary~        -  To define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of~          temsirolimus in combination with pegylated liposomal doxorubicin in patients with~          resistant solid malignancies.~        -  To determine the incidence and severity of other toxicities of temsirolimus in~          combination with pegylated liposomal doxorubicin in patients with resistant solid~          malignancies.~      Secondary~        -  To assess the pharmacokinetic profile of temsirolimus in combination with pegylated~          liposomal doxorubicin.~        -  To determine any anti-tumor activity and response to the combination of temsirolimus and~          pegylated liposomal doxorubicin in treatment of patients with resistant solid~          malignancies.~   "
218157|NCT00703612|"~     The purpose of this study is to determine whether intravenous administration of autologous~     adipose-derived stem cells is of benefit in the management of types 2 diabetics.~   "
218158|NCT00703599|"~     The purpose of this study is to determine whether intravenous administration of autologous~     adipose stem cells is safe and beneficial in patients with type 1 diabetes.~   "
218159|NCT00703586|"~     Hypothesis: Intensification of current ARV regimens with maraviroc will result in more~     complete suppression of viral replication, particularly in the gastrointestinal mucosa with~     resultant reduction in markers of immune activation and improved GI immune reconstitution.~   "
218160|NCT00703573|"~     The purpose of this study is to evaluate the safety and efficacy of 2 doses of S-777469 in~     patients with atopic dermatitis.~   "
218161|NCT00703560|"~     The purpose of this study is to evaluate what happens to hepatitis C virus in response to~     treatment with pegylated interferon and ribavirin in patients with HCV compared to those with~     HIV and HCV.~      This research is being done to help us identify how the composition of HCV changes with~     interferon in different populations. We will examine how quickly HCV is cleared from your~     body and what factors may influence that clearance. This information may help us find better~     treatments for HCV.~   "
218162|NCT00703547|"~     A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male~     subjects. Subjects will be divided into two cohorts with alternate panel design. The study is~     investigating the safety, tolerability and pharmacokinetics of single oral escalating doses~     of GSK586529.~   "
218163|NCT00703534|"~     This research study is being done to gather information about how to do further clinical~     studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).~   "
218164|NCT00703521|"~     Background. The World Health Organization recommends pre-exposure vaccination (PreP) to~     protect children living in canine rabies endemic countries. Including PreP in national~     childhood immunization programs (EPI) is a viable option.~      Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to~     receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM~     (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of~     Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or~     JEV alone was administered concomitantly one year after primary vaccination. Safety was~     evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to~     booster and on days 7 and 28 post-booster, and at two and three years post primary~     vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA,~     JEVNA).~   "
218165|NCT00703508|"~     1. The polycystic ovary syndrome is the major cause of infertility in the United States.~          Metformin has been shown to increase frequency of ovulations in PCOS, and is used in~          clinical practice to treat infertility, but some women with PCOS do not respond to~          metformin treatment.~        2. Knowing that a specific gene predicts the effect of metformin on ovulation would~          facilitate more efficient and effective treatment of infertility in PCOS.~   "
218166|NCT00703495|"~     The purpose of this study is to investigate the relationship among regional transcranial~     oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion~     pressure (CPP) in patients with severe traumatic brain injury (TBI).~   "
218167|NCT00703482|"~     The purpose of this study was to study the effect of different combinations of fenofibrate~     and coenzyme Q10 on ventricular diastolic function in patients with Type II diabetes~   "
218168|NCT00703469|"~     This study examines the safety, tolerability, and immunogenicity of a single dose of MDX-1106~     in patients with active hepatitis C genotype 1 or mixed hepatitis C genotype infection.~   "
218169|NCT00703456|"~     The aim of this study is to determine the effect of a balance training intervention on the~     change in hyper-reactivity to unloading reaction, ankle joint laxity, ankle joint~     proprioception and evertor muscle weakness in individuals with functional ankle instability~     (FAI) using quantitative biomechanical and neuromuscular measurements.~      We hypothesize that experimental FAI group will demonstrate a significant decline in~     unloading reaction following balance training while FAI control group will not show a~     significant decline in unloading reaction without training. We further hypothesize that~     experimental FAI group will demonstrate a significant improvement in the FAI score after the~     balance training measured by Ankle Instability questionnaire. Following balance training,~     there will be a significant correlation between the change in FAI score and change in the~     unloading reaction in the experimental group.~   "
218170|NCT00703443|"~     The purpose of this study is to determine the genetic basis of cardiomyopathies and heart~     failure.~   "
234046|NCT00492466|"~     This study is to find out if Interferon-beta can recover its effectiveness in patients with~     Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.~   "
218172|NCT00703417|"~     For this cross-sectional case control pilot study 30 women, 55-75 years old with type II~     diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously~     diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl~     (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient~     population will be divided into 2 groups: patients with status post low energy fractures of~     the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic~     patients with no fractures or low energy trauma fracture history (n=10). An additional group~     of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance~     imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined~     since a previous study suggested that BMD is very similar in these 3 population and that~     ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched,~     race-matched healthy women, without osteoporotic fractures will be examined. In all of these~     volunteers a medical history will be obtained to ensure good health status and rule out~     chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT~     and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to~     determine bone mineral density and bone structure/quality.~      The hypothesis of this pilot project is that type II diabetic patients with and without~     low-energy fractures have a different trabecular bone architecture and composition, which is~     also different when compared to normal age-matched healthy patients. Architectural~     differences in these three patient groups may be visualized with high resolution MRI and~     high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most~     pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained~     from high resolution MRI and spectroscopy may improve our understanding of the~     pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly~     diabetic population.~   "
218173|NCT00703404|"~     This study will evaluate the effectiveness of first-line HIV treatment (fixed-dose~     combination of the generic antiretroviral drugs nevirapine, stavudine and lamivudine)~     provided by the Malian National HIV Treatment Program. Antiretroviral therapy has become a~     priority because of its proven effectiveness in decreasing sickness and death from HIV~     infection. Reliable information on its efficacy is needed.~      Patients 18 years of age and older who enter the Malian National HIV Treatment Program and~     have not had prior antiretroviral treatment may be eligible for this study.~      Primary Objective~      The primary objective is to measure the virologic treatment response at 24 weeks to the~     Malian-approved fixed-dose regimen (FDC) of nevirapine, stavudine and lamivudine (Triomune)~     in patients who are na(SqrRoot) ve to antiretroviral therapy in Bamako, Mali compared to a~     historical cohort as a prelude to further clinical research investigations in Mali.~      Secondary Objectives~        1. To assess the association of the 24 week response with the response at one year as~          measured by suppression of viremia to less than 50 copies/mL~        2. To evaluate the baseline clinical and HIV-associated characteristics of a cohort of~          persons who are enrolled in protocol-mandated monitoring.~      Participants undergo treatment in the government-sponsored program. Clinical visits are~     scheduled at study days 0 (antiviral therapy start day) and 14, and at 1, 3, 6, 9 and 12~     months. Patients undergo a medical history, including all confirmed and probably diagnoses~     made since the previous visit and current status, physical examination and blood tests for~     CD4 and viral load at each visit.~      Study start date: July 2008~   "
218174|NCT00703391|"~     The purpose of this study is to assess the tolerability (effect of drug on body) and~     pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD~   "
218175|NCT00703378|"~     Primary Objective~      1. To develop a pharmacokinetic-pharmacodynamic (PD) model for optimisation of docetaxel~     dosing~      Secondary Objectives~        1. To establish an exposure-toxicity (neutropenia) relationship for docetaxel~        2. To determine the exposure breakpoint for docetaxel toxicity based on a neutropenia PD~          model~        3. To identify demographic, pathophysiological and/or phenotypic covariates predicting~          docetaxel clearance~        4. To prospectively validate this PK-PD model for optimisation of docetaxel dosage and~          determination PK variability and toxicity~   "
218176|NCT00703365|"~     This study is to evaluate the efficacy and safety of Sorafenib in combination with~     Gemcitabine in patients with advanced/unresectable HCC.~   "
218177|NCT00703352|"~     BACKGROUND: There is no clinical evidence supporting medical treatment for the failing~     systemic right ventricle in patients with transposition of the great vessels with atrial~     switch. Cardiac magnetic resonance studies have shown a significant degree of myocardial~     fibrosis in right ventricles in the systemic position, which predisposes to systolic and~     diastolic dysfunction. Aldosterone is a widely recognized neurohormonal marker involved in~     the formation of myocardial fibrosis and the treatment with aldosterone antagonists has shown~     a decrease in ventricular mass in hypertensive patients, presumably related to reduction of~     myocardial fibrosis.~      HYPOTHESIS: Low dose of eplerenone, a selective mineralocorticoid receptor blocker, in~     patients with systemic right ventricle can reduce the ventricular mass by means of a~     reduction in myocardial fibrosis, resulting in improved systolic function.~      PATIENTS AND METHODS: Randomized, double blind, parallel clinical trial comparing eplerenone~     (50mg daily) with placebo.~      Study population: Adult patients (>18 years) diagnosed with repaired transposition of the~     great arteries with atrial switch (Senning or Mustard techniques) routinely followed at a~     tertiary referral center.~      Duration: 12 months. Outcomes: Right ventricular mass, myocardial fibrosis mass and ejection~     fraction assessed by cardiac magnetic resonance.~   "
218178|NCT00703339|"~     The purpose of this study is to establish single-dose tolerability of inhaled treprostinil~     sodium in idiopathic pulmonary fibrosis (IPF) patients with pulmonary hypertension, and to~     explore the acute hemodynamic effects over a range of tolerable doses. The safety and~     pharmacodynamic information obtained from this study will inform the design and conduct of~     future studies in inhaled treprostinil sodium in this population.~   "
218179|NCT00703326|"~     The objective of this study is to compare the progression-free survival (PFS) of the drug~     combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated~     participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable,~     locally-recurrent or metastatic breast cancer.~   "
218180|NCT00703313|"~     The primary objective of this study is to compare the concentration in human tears of~     levofloxacin and the active comparators at 15 minutes, 2,6, 12, and 24 hours after~     instillation of a single drop of medication.~   "
218181|NCT00703300|"~     This phase I trial is studying the side effects and best dose of bortezomib when given~     together with decitabine in treating patients with acute myeloid leukemia. Bortezomib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving bortezomib~     together with decitabine may kill more cancer cells.~   "
234047|NCT00492453|"~     The purpose of the study is to assess whether spinal anesthesia is or not superior to the~     standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.~   "
218183|NCT00703274|"~     The purpose of this study is to refine and evaluate the Preventing Recurrence of~     Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC)~     intervention. PROTECT DC is a program consisting of in-hospital education coupled with~     community-based stroke navigators and is designed to reduce the rate of vascular events or~     death in a population of underserved individuals with stroke.~   "
218184|NCT00703261|"~     The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose~     Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.~   "
218185|NCT00703248|"~     Treatment options that increase immune function, such as Osteopathic Manipulation Treatment~     (OMT) lymphatic techniques, may provide improved short or long term performance of the immune~     system. However, the efficacy of OMT to boost immune function among people living with HIV~     has not yet been examined in a controlled study. Our experiment is designed to examine the~     short (45 minutes) term impact of OMT on the white blood cells counts of HIV positive men who~     are either antiretroviral therapy (ART) naïve or have not taken ART for at least 12 months~     prior to enrollment in the study.~   "
218186|NCT00703235|"~     Diabetic macular edema is a common cause of visual loss among diabetic patients. Studies have~     demonstrated the role of vascular endothelial growth factor (VEGF) in the pathogenesis of~     edema.~      This study designed to evaluate the effect of Intravitreal injection of a recombinant~     monoclonal anti-VEGF antibody, Bevacizumab, for treatment of diabetic macular edema.~   "
218187|NCT00703222|"~     The investigators intend to test the safety, and immunologic and clinical efficacy of a~     combination of 2 allogeneic neuroblastoma tumor cell line vaccines, one of which has been~     genetically modified to secrete the cytokine/chemokine combination of IL-2 and lymphotactin,~     in patients undergoing chemotherapy for newly diagnosed, high risk neuroblastoma who receive~     single autologous stem cell rescue as consolidation therapy.~      This protocol will be carried out as a Phase I/IIa study to evaluate the safety and toxicity~     of adding a previously unstudied, unmodified, irradiated neuroblastoma cell line (SKNLP) to a~     studied, safe dose of a gene modified, IL-2/Lptn secreting neuroblastoma cell line~     SJNB-JF-IL2/Lptn to be given as a vaccine to patients diagnosed with high risk neuroblastoma.~   "
218188|NCT00703209|"~     The UT Southwestern Medical Center at Dallas would like to give you information about a~     research study that is being done for patients with painful diabetic neuropathy and have not~     responded to medical treatment. Doctors from the departments of Internal Medicine, Physical~     Medicine and Rehabilitation, Neurology, Pain Management and Plastic Surgery are conducting a~     research study to examine the effects of nerve decompression on decreasing the pain~     associated with diabetic neuropathy and increasing the sensation at the bottom of the foot.~   "
218189|NCT00703196|"~     RATIONALE: Supplements, such as folic acid, may stop or delay the development of cervical~     cancer in women infected with human papillomavirus.~      PURPOSE: This phase II trial is studying how well folic acid supplements work in preventing~     cancer in women infected with human papillomavirus.~   "
218190|NCT00703183|"~     The purpose of this study is to evaluate the safety and tolerability of a new investigational~     drug (ACU-4429) in healthy human volunteers.~   "
218191|NCT00703170|"~     Rationale:~      The Mammalian Target of Rapamycin (mTOR) is a large polypeptide serine/threonine kinase of~     289 kDa; kinases have been shown to be important regulators of cancer cell cycle,~     proliferation, invasion, and angiogenesis, and mTOR has been shown to have a key role in the~     signaling of malignant cell growth, proliferation, differentiation, migration, and survival.~     Inhibition of mTOR would result in arrest of cell growth in the G1 phase of the cell cycle.~      Temsirolimus (CCI-779) is a soluble ester analogue of rapamycin (sirolimus) which has shown~     impressive in vitro and in vivo cytostatic activity in selectively inhibiting mTOR. In animal~     models, temsirolimus has demonstrated an impressive cytostatic effect on a wide variety of~     cancer cells. In vitro, it inhibited the growth of human T-cell leukemia, glioblastoma,~     melanoma, prostate, breast, renal cell, and pancreatic cells, all of which showed particular~     sensitivity to temsirolimus, with significant growth inhibition at concentrations of less~     that 0.01micrometer. In Phase I trials, temsirolimus has been investigated as a single agent~     on a weekly schedule as well as daily for 5 days every other week, and evidence of activity~     was observed over the entire dose range (15 - 220 mg/m2) in patients with both breast and~     renal cancer. There was no apparent relationship between exposure and clinical benefit,~     suggesting that the inhibition of mTOR may be achieved at doses well below dose levels that~     result in dose limiting toxicities. Major tumor responses were noted in Phase I trials in~     patients previously treated with lung, breast, renal as well as neuroendocrine tumors. Minor~     responses were noted in soft tissue sarcoma, endometrial, and cervical carcinoma.~      Pegylated liposomal doxorubicin has been FDA approved for use in refractory metastatic~     ovarian cancer and AIDS-related Kaposi's Sarcoma. It has also been shown to be effective in~     previously treated metastatic breast cancer.~      Combination studies in preclinical models suggest that rapamycin and its analogues are at~     least additive in effect with standard chemotherapy and radiation. In addition, studies in~     breast cancer cell lines suggest that the mTOR inhibitors may reverse resistance to~     anti-estrogen agents. Thus, we are proposing that the combination of temsirolimus and~     liposomal doxorubicin will be highly effective in metastatic solid tumor malignancies.~      Objectives:~      Primary~        -  To define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of~          temsirolimus in combination with pegylated liposomal doxorubicin in patients with~          resistant solid malignancies.~        -  To determine the incidence and severity of other toxicities of temsirolimus in~          combination with pegylated liposomal doxorubicin in patients with resistant solid~          malignancies.~      Secondary~        -  To assess the pharmacokinetic profile of temsirolimus in combination with pegylated~          liposomal doxorubicin.~        -  To determine any anti-tumor activity and response to the combination of temsirolimus and~          pegylated liposomal doxorubicin in treatment of patients with resistant solid~          malignancies.~   "
218192|NCT00703157|"~     Prospective randomized interventional trial comparing the efficacy of circumferential~     pulmonary vein ostia ablation using surgical versus catheter techniques in the treatment of~     paroxysmal atrial fibrillation. Success rate determined by REVEAL-XT (AF implantable~     monitoring device).~   "
218193|NCT00703144|"~     The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients~     with renal failure undergoing continuous veno-venous hemodiafiltration.~   "
218194|NCT00703131|"~     The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study~     the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal~     fistulas.~   "
218195|NCT00703118|"~     The purpose of this study is to determine the safety, efficacy and tolerability of using two~     regimens of telaprevir (with and without delayed start) with standard treatment compared to~     standard treatment alone in participants with chronic, genotype 1, hepatitis C.~   "
218208|NCT00702949|"~     RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer~     or those who have no history and do not wish to take estrogen therapy for fear of increased~     risk of breast cancer. It is not yet known what dose of pregabalin may be more effective in~     treating hot flashes.~      PURPOSE: This is a randomized phase III trial to determine the efficacy of two doses of~     pregabalin, in comparison to placebo, in the prevention of hot flashes.~   "
218209|NCT00702936|"~     The purpose of this study is to compare the antinflammatory and endothelial progenitor cell~     (EPC) mobilizing effect of Ramipril and Telmisartan in patients presenting with acute~     coronary syndrome~   "
250603|NCT00271934|"~     In patients with systemic lupus erythematosus, immunosuppressive therapy to the point of~     complete immune ablation and hematopoietic stem cell recovery.~   "
218196|NCT00703105|"~     The purpose of this study is to determine if an immune modifying drug (Ontak) alone or as~     part of a vaccine therapy will produce remissions in patients with advanced ovarian cancer.~     This research is being done because we want to find new therapies for treatment of relapsed~     or refractory (resistant to ordinary treatment) ovarian cancer. The use of ONTAK and vaccine~     therapy is research.~      A new experimental approach for treating refractory or relapsed ovarian cancer involves using~     the patients own immune system to kill the cancer cells. These immune cells are called~     monocytes and are harvested from blood. The process of Leukapheresis collects the monocytes~     called Dendritic Cells. This is usually a 3 hour process done in the comfort of a hospital~     bed in the apheresis lab, similar to giving blood for donation. Approximately 300cc's are~     collected during this process, the equivalent of about 10 ounces of blood. Once these~     dendritic cells are collected - a special laboratory grows and processes them into a vaccine~     using a patient's own tumor cells. This preparation is then given back to the patient~     hopefully to stimulate the immune system to kill cancer cells. This type of treatment is~     considered biological research.~      This study also involves a drug called ONTAK, which is made using certain proteins from~     diphtheria toxins and interleukin-2 (chemotherapy drug). This drug will act on immune~     suppressing cells normally present in your body making vaccine therapy possibly less~     effective. Ontak helps set up your immune system to be boosted by the vaccine injections. The~     use of Ontak followed by the vaccine to stimulate your tumor killing immune cells has not~     been done in ovarian cancer before and is research.~   "
218197|NCT00703092|"~     The purpose of this study is to determine whether 6 months of fiber supplementation will~     improve ovulation in women with polycystic ovary syndrome (PCOS).~   "
218198|NCT00703079|"~     To investigate the 60 month impact of surgery and somatostatin analogues (SSA) on glucose~     metabolism in acromegaly we will analyzed data from 100 patients with acromegaly according~     with different treatments (group A=with SSA only; group B= SSA followed by surgery; group C=~     surgery only; group D= surgery followed by SSA). At diagnosis and after 6-12 and 60 months~     were analyzed as primary outcome measure changes in fasting glucose and as secondary outcome~     measures changes of glycated hemoglobin (HbA1c) and insulin levels, HOMA-R and HOMA-β,~     representing insulin resistance and β-cell function, respectively.~      We will enrol 100 patients and expect half of them to have IGT or diabetes mellitus. We do~     not expect changes according with different treatment after 60 months while SSA-treated~     patients might experience deterioration of glucose tolerance after 6-12 months. We intend to~     look for predictors of deterioration of glucose tolerance.~   "
218199|NCT00703066|"~     The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already~     publicly used vaccine against rabies. 30 Gabonese children aged 1-5 years will be enrolled~     and randomly allocated to receive either malaria vaccine or rabies vaccine without the~     investigator or the participants knowing what they received. They will receive 3 doses each~     at one month intervals, and will be followed up for one year to evaluate safety parameters.~     30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety.~      This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the~     first time being in Gabonese adults where the product was found to be safe.~   "
218200|NCT00703053|"~     Severe disease in humans due to bird influenza viruses (H5N1) has led to concern that this~     virus may result in a widespread outbreak of bird flu. The purpose of this study is to~     evaluate the dose and dosing schedule for 2 different types of H5N1 vaccine. Participants~     will be randomly assigned to 1 of 9 possible vaccine groups. All participants will receive 2~     doses of Clade 1, Clade 2, or combination Clade 1 and 2 on Day 0. All participants will~     receive a second dose of the same vaccine or a different vaccine type on study day 7, 14, 28~     or 180. Study participants will include about 500 healthy adult subjects, ages 18-49 years~     old, who have no history of prior H5 flu exposure or vaccination. Study procedures may~     include medical history, physical exam, and blood sampling. Subject participation may last up~     to 372 days. Several DMID studies have recently evaluated H5N1 vaccines in healthy adults,~     04-063, 05-0090, 05-0015, and 05-0043.~   "
218201|NCT00703040|"~     This first phase of a two-phase study involves three components:~        1. Review of existing linkage-to-care protocols and sources of referrals for care;~        2. Semi-structured telephone or face-to-face interviews with a minimum of two personnel per~          site who are associated with linkage to medical care. (Preference will be given to~          personnel with direct experience in linkage to care); and~        3. Structured observations of referral sessions.~   "
218202|NCT00703027|"~     We tried to use data mining method to find out the new model of factors that affects the~     progression of diabetes mellitus.~   "
218203|NCT00703014|"~     The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the~     induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS)~     prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for~     pregnant participants and their offspring. The primary endpoint was the take-home baby rate~     calculated as the number of participants with an ongoing pregnancy in Base Trial P05787~     (NCT00696800) with at least one live born infant relative to the number of participants in~     the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer~     (ET).~   "
218204|NCT00703001|"~     The Waukesha Smiles Project will compare approaches to improve oral health habits and~     increase access to basic dental care for low-income children in Waukesha, Wisconsin through a~     school-based outreach program of oral health promotion, screening and referral.~   "
218205|NCT00702988|"~     The objective of this trial was to evaluate whether Org 36286 treatment for the induction of~     multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro~     fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant~     subjects and their offspring.~   "
218206|NCT00702975|"~     A phase II study of combination therapy of carboplatin -gemcitabine plus bevacizumab beyond~     progression in patients with locally advanced and/or metastatic non-small cell lung cancer~     (NSCLC) who have not received prior chemotherapy.~   "
218207|NCT00702962|"~     The Phase I portion of the study is to assess the maximum tolerated dose of vorinostat when~     combined with carboplatin plus etoposide. The Phase II portion is to determine~     progression-free survival among patients with extensive disease small cell lung cancer~     receiving carboplatin plus etoposide with vorinostat.~   "
218210|NCT00702923|"~     The current protocol will evaluate the safety of combining treatment with~     bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with~     PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with~     safety the primary endpoint. Secondary endpoints will be to determine whether prostate~     associated immune responses are seen, and whether treatment is associated with an increase in~     PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of~     six patients will be treated in each dose level. The investigators hypothesize that~     short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell~     mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4,~     and that this will have therapeutic benefit in patients with recurrent prostate cancer.~   "
218211|NCT00702910|"~     This study will involve the use of a new medicine called GW642444 being developed for the~     treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the~     study is to see how safe and how well tolerated the study drug is when inhaled in two~     different formulations as a fine powder by asthmatic patients. In addition, the study is~     designed to examine the effect of the study drug on the lungs, how the study drug affects~     parts of the body other than the lungs and to see how the body affects the study drug when it~     is given in single doses.~   "
218212|NCT00702897|"~     OBJECTIVE: To retrospectively analyze the results of ambulatory treatment on Taiwanese~     patients with primary varicosities of the lower extremities including the use of endovenous~     laser, phlebectomy, and sclerotherapy.~      METHODS: We routinely used tumescent anesthesia and ultrasound-guided approaches for the~     application of endovenous laser. Vein access was achieved by either a percutaneous or stab~     wound. The laser power was usually 10 - 20 watts; laser treatment usually was begun from 4-10~     cm below the saphenofemoral junction, and stopped around the knee, not over 10 cm below the~     knee. In the same operation, we used Mueller's phlebectomy and/or sclerotherapy if there were~     prominent branch varicosities. We instructed each patient to walk around immediately after~     the operation, to go home, and to come back 1-3 days later for follow-up. Ultrasound scan and~     venous function follow-up was scheduled at 1 month, 6 months, 12 months, and then annually.~   "
218213|NCT00702884|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     relapsed or refractory esophageal or gastroesophageal junction cancer.~   "
218214|NCT00702871|"~     Objective of this study was to determine incidence, risk factors, etiological micro-organisms~     and their antimicrobial susceptibility pattern and outcome of VAP; and to study effect of~     ranitidine vs. sucralfate, used for stress ulcer prophylaxis, on gastric colonization and on~     occurrence of VAP.~      Methods: Design: Prospective randomized study. Setting: ICUs of Medicine Department and~     Anesthesiology Department, Maulana Azad Medical College and Lok Nayak Hospital, University of~     Delhi, New Delhi. Patients: 50 patients of age more than 12 years, who had been on ventilator~     for more than 48 hrs. Intervention: Endotracheal Aspirate and blood sample of all patients~     were cultured to determine micro-organisms causing VAP and their antimicrobial susceptibility~     pattern. Patients were divided into 2 groups on random basis. The first group was given~     ranitidine for stress ulcer prophylaxis while the second was given sucralfate. Thereafter,~     difference in gastric colonization (on basis of quantitative culture of nasogastric aspirate)~     and on occurrence of VAP in both the groups was compared.~      Study Hypothesis: Study was designed to create data about Ventilator associated pneumonia in~     developing countries like India. This data is crucial for providing information for deciding~     future guidelines for treatment of and prevention of Ventilator associated pneumonia. Further~     to test the hypothesis that H2 blockers, by virtue of raising gastric Ph, increase gastric~     colonization by pathogenic organism and increase incidence of Ventilator associated~     pneumonia; patients were divided into two groups on random basis, as described above.~   "
218215|NCT00702858|"~     This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases~     joint and bone pain associated with Aromotase Inhibitor therapy (AIT).~      Another purpose of the study is to find out if Blue Citrus improves how you feel while taking~     AIT and if your quality of life improves.~   "
218216|NCT00702845|"~     Clinical trial objectives are to investigate the efficacy and safety of a single injection of~     100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for~     controlled ovarian stimulation (COS), using daily recFSH as a reference.~   "
218217|NCT00702832|"~     The aim of this study is to assess if early supported vestibular rehabilitation can reduce~     dizziness and improve daily life activities in patients with acute vestibular injury.~      The study question is: Does early supported vestibular rehabilitation have an additional~     effect on dizziness symptoms and daily life functions compared to standard treatment?~   "
218218|NCT00702819|"~     Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed~     countries around the world, and an increasing cause of blindness in developing countries.~      The retina lines the inside of the eye. It functions as film within the camera which is the~     eye. When an infant is born prematurely, the vascular network necessary to nourish the retina~     has not fully developed. As a consequence, in some infants abnormal vessels proliferate~     instead of the normal ones - a condition known as ROP. The abnormal vessels carry scar tissue~     along with them, and may lead to retinal detachment and blindness if the eye is not treated.~      The Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Study~     demonstrated that ablation of the peripheral avascular retina reduced the risk of poor~     structural and visual outcome due to retinal distortion or detachment in ROP (1980's). The~     ablated retina is not functional and is not amenable to regeneration.~      Peripheral retinal ablation is not universally effective in fostering regression of ROP. This~     is particularly true for an aggressive form of ROP (aggressive posterior ROP, or APROP) which~     typically afflicts profoundly premature and infirm neonates. In this subset of infants,~     progression of ROP to bilateral retinal detachment and blindness occurs despite timely and~     complete peripheral retinal laser ablation.~      Rationale The development of ROP is largely dependent on vascular endothelial growth factor~     (VEGF). When an infant is born prematurely the relatively hyperoxic environment the baby is~     introduced to shuts down the production of VEGF. Retinal maturation is delayed. Subsequently,~     at a time when intraocular VEGF levels would normally be declining late in the third~     trimester of pregnancy, abnormally high levels of VEGF are seen due to large areas of~     avascular retina and associated tissue hypoxia.~      The availability of FDA-approved drugs for anti-VEGF treatment renders it possible to treat~     such eyes off-label. Available drugs include pegaptanib sodium (Macugen) for partial blockage~     of VEGF-A, or drugs such as ranibizumab (Lucentis) and bevacizumab (Avastin), which cause~     complete blockage of VEGF-A.~      As VEGF is required in the developing retina for normal angiogenesis, and our goal is not to~     penetrate tissue, but to block the excessive levels of VEGF trapped within the overlying~     vitreous which is responsible for the abnormal vasculature in ROP.~      For purposes of this study the investigators have chosen bevacizumab (Avastin), which will:~     a) attain complete blockage (vs. Macugen) of intravitreal VEGF-A, and; b) which is limited in~     its ability to penetrate tissues because it is a full antibody (vs. Lucentis, an antibody~     fragment specifically designed for better tissue penetration), and is more likely to restore~     VEGF homeostasis within the developing retina.~   "
218219|NCT00702806|"~     The primary objective of this trial was to investigate the appropriate dose of a single~     injection of Org 36286 to initiate multifollicular growth for the first seven days in a~     controlled ovarian hyperstimulation (COH) protocol for IVF and IVF/ICSI. After seven days,~     participants were converted to treatment with Puregon® 150 IU and administration of the GnRH~     antagonist Orgalutran® to finalize the stimulation cycle. Secondary objectives were the~     safety (including the absence of antibody formation) and the direct effects of Org 36286 on~     reproductive functions (steroidogenesis, oocyte maturation, embryo quality and implantation).~   "
218220|NCT00702793|"~     This is a 15 week trial to determine (1) the safety and tolerability of varenicline when used~     for smoking cessation/reduction in individuals with schizophrenia; (2) if treatment with~     varenicline affects the symptoms of schizophrenia.~   "
218221|NCT00702780|"~     This study aimed to test whether escitalopram would slow the brain atrophy in patients with~     mild to moderate AD over the 52-week period.~   "
218222|NCT00702767|"~     This study was completed in October 2006. No further participates are being recruited.~   "
218223|NCT00702754|"~     Five hundred patients with a confirmed clinical diagnosis of Cervical Dystonia (CD)are~     planned for enrollment into this open label study. These patients will be Type B toxin naive~     patients with CD. During this study patients will receive repeat injections of MYOBLOC when~     deemed appropriate by the Investigator. However, it will be recommended that injections occur~     not more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be~     targeted for at least two years, with potential exposure for up to 7 years in patients with~     earliest enrollment~   "
218224|NCT00702741|"~     The objective of the present study is to establish the long-term safety of an intra-articular~     injection of human mesenchymal stem cells (hMSCs) (Chondrogen).~   "
218225|NCT00702728|"~     This study is being proposed with the objective to assess the potential benefits of induced~     diuresis by furosemide with matched hydration therapy compared to standard hydration in the~     prevention of contrast-induced nephropathy (CIN). It is expected that matched hydration will~     prove to be as effective as hydration alone, will avoid an overnight stay prior to the~     procedure, and thus will prove to be a less costly and more clinically manageable solution to~     the prevention of CIN.~   "
218226|NCT00702715|"~     The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on~     efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison~     to subjects with normal renal function.~   "
218227|NCT00702702|"~     Eligible female subjects will be randomly assigned to one of the three treatment groups.~     Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily~     during study drug treatment. The study duration is approximately six months, which is~     comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a~     one-month follow-up period.~   "
218228|NCT00702689|"~     Background:~      Chronic graft-versus-host disease (GVHD) is a common complication of stem cell transplant,~     resulting from the donor's immune cells attacking the cells of the body of the recipient. One~     effect of GVHD is fibrosis (scarring) of the skin that can lead to impaired function,~     decreased quality of life and increased risk of death. This is known as sclerotic skin~     changes of GVHD, or sclerodermatous graft versus host disease (ScGVHD).~      Imatinib mesylate (Gleevec) is a drug that has been approved by the Food and Drug~     Administration to treat cancer in humans and fibrosing conditions in animals.~      Objectives:~      To see if imatinib mesylate can improve ScGVHD and evaluate its effect on other GVHD symptoms~      To assess the side effects of imatinib mesylate in patients with GVHD~      To evaluate blood, body fluids and tissue samples in patients to try to better understand the~     biology of ScGVHD~      Eligibility:~      Patients 4 years of age and older with ScGVHD~      Design:~      Initial treatment: Participants take imatinib mesylate tablets once a day for up to 6 months,~     as long as their GVHD does not get worse and they do not develop unacceptable side effects of~     the drug.~      Evaluations: Participants are evaluated at 1, 3 and 6 months at the National Institutes of~     Health (NIH) Clinical Center with procedures that may include the following:~      Medical history and physical examination~      Blood and urine tests~      Lung function test~      Skin biopsy~      Magnetic resonance imaging (MRI) scan~      Specialty consultations (e.g., physical or rehabilitative therapy, dentist, eye doctor,~     dermatologist)~      Electrocardiogram (EKG)~      Echocardiogram (ultrasound test of the heart)~      Muga scan (nuclear medicine test of the heart)~      Quality-of-life questionnaires~      Apheresis (procedure for collecting quantities of white blood cells)~      Office visits with local physician once a week for 1 month, then once every 2 weeks for 5~     months~      Followup visits at National Institutes of Health (NIH) every 6 months for 1 year~      Continuing treatment: Patients who improve continue to receive imatinib mesylate for up to 6~     months after their best response and are followed for up to 2 years. Patients who continue to~     respond or who become worse after stopping treatment may receive additional treatment for up~     to 2 years.~   "
218229|NCT00702676|"~     This study will compare the tolerability of Quetiapine Fumarate immediate release formulation~     and Quetiapine Fumarate extended release formulation during initial dose escalation in~     healthy volunteers.~   "
218230|NCT00702663|"~     The aim of this study is to observe and evaluate initiate serum anti-HBs titers during~     entrance health examination among undergraduate freshmen in a university who showed a~     complete 4-dose HBV vaccination in infancy and whose serum status was (1) HBsAg negative and~     anti-HBc negative and (2) anti-HBc positive alone. For those students whose anti-HBs <10~     mIU/ml, additional HBV vaccination boosters were given according to routine governmental~     suggested schedules. The anamnestic effect then is observed in both groups. The results of~     this study may contribute to the analysis of the effectiveness of anti-HBV vaccination twenty~     years after the commencement of the program and the necessity of initiating HBV booster~     program among Taiwanese young adults.~   "
218231|NCT00702650|"~     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.~     Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous~     solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of~     this product. The study will also assess safety of the product.~   "
218232|NCT00702637|"~     The purpose of this study is to determine whether Modafinil is effective in: (1) reducing~     fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury~     (TBI); and (2) improving cognitive function and quality of life in individuals with TBI.~   "
218233|NCT00702624|"~     The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286)~     treatment for the induction of multifollicular growth in women undergoing controlled ovarian~     stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection~     (ICSI) is safe for pregnant participants and their offspring.~   "
218234|NCT00702611|"~     The purpose of this study is to evaluate the efficacy of the addition of GMA apheresis to~     steroid conventional treatment for achieving and maintaining remission in Active steroid~     dependant Ulcerative Colitis patients~   "
234577|NCT00485472|"~     The purpose of this trial is to evaluate the effectiveness, safety and tolerability of~     lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.~   "
218235|NCT00702598|"~     This study will investigate the additional benefits of telephone-based cognitive behavioral~     therapy (Tel-CBT) as added treatment to an antidepressant (escitalopram) in working people~     with major depressive disorder (MDD) versus treatment with escitalopram alone. Outcomes will~     include depression symptom rating scales and measures of work absence and productivity. The~     hypothesis is that Tel-CBT and escitalopram will result in better outcomes than escitalopram~     alone in working patients with MDD.~   "
218236|NCT00702585|"~     The objectives of this trial were to investigate the feasibility and the optimal dose of a~     single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group~     II anovulatory infertility and to assess the safety (including the absence of antibody~     formation) of Org 36286.~   "
218237|NCT00702572|"~     The primary objective of the study is to establish the phase II recommended dose of~     Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and~     bevacizumab for patients with previously untreated advanced non-small cell lunc cancer.~   "
218238|NCT00702559|"~     Most patients with end-stage renal disease require hemodialysis. An arteriovenous fistula~     (AVF) or a prosthetic arteriovenous graft (AVG) is the preferred accesses for this. After its~     surgical creation, the fistular vein immediately faces a tremendous blood flow and the venous~     lumen is gradually dilated and the wall thickened, producing an access that can be routinely~     needled and deliver sufficient blood flow for dialysis. However, many hemodialysis patients~     will experience access stenosis, dysfunction, and even thrombosis, which are the most common~     complications of a hemodialysis access.~      Most physicians, in-charge nurses of the hemodialysis unit, patient, and/or the family use~     traditional stethoscope as a convenient method to evaluate the patency and function of a~     hemodialysis access before, during, and after each session of dialysis. The acoustic signal~     of an access is always affected by environmental noises, non-specific in nature, and the~     sensitivity to detect stenosis is very low.~      With the development and use of electronic stethoscope, the proprietary ambient noise~     acoustically cancels out an average of 75% of distracting room noise, greatly enhancing~     overall utility. However, the output acoustic signals are still apprehended by the ear, which~     is the main source of bias and errors of detection.~      Our study purpose is to apply the signal processing technology to transfer the acoustic~     signals into simple visual signals that provide an easy way to read. It can be used by a~     professional medical staff, a non-professional person responsible for taking care, or even~     the patient himself, disability or not, as an early screening detector of stenosis or~     dysfunction of a hemodialysis access.~   "
218239|NCT00702546|"~     Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET)~     cycles performed after the embryos are cryopreserved in the base study P05690 in order to~     estimate the cumulative pregnancy rate for each treatment group.~   "
218240|NCT00702533|"~     Background:~      - Acid-related gastrointestinal disorders are numerous and may require chronic treatment and~     maintenance, but they are often difficult to diagnose and treat. Gastric analysis is a~     critical tool for diagnosing and treating acid-related disorders; however, at present it~     requires a technically difficult procedure, using a nasogastric tube, that is costly,~     invasive, and uncomfortable. Recently a new tool, the SmartPill, has been developed that can~     measure acid levels, temperature, and pressure throughout the stomach, small intestine, and~     colon by swallowing a small capsule. Researchers are interested in comparing current methods~     of measuring stomach acid with the SmartPill by studying both healthy volunteers and~     individuals with acid-related gastrointestinal disorders.~      Objectives:~      - To evaluate the usefulness and accuracy of the SmartPill for gastric analysis, compared~     with current procedures.~      Eligibility:~        -  Phase 1A/1B: Healthy volunteers between 18 and 60 years of age.~        -  Phase 2: Individuals at least 18 years of age who have been diagnosed with~          Zollinger-Ellison Syndrome or acid hypersecretion.~        -  Phase 3: Individuals at least 18 years of age who have been diagnosed with refractory~          gastroesophageal reflux disease, peptic ulcer disease, or idiopathic gastric~          hypersecretion.~      Design:~        -  This study involves a screening visit, a 3-day inpatient study visit, and possible~          additional outpatient visits.~        -  Participants will be screened with a medical history and physical examination, as well~          as blood and urine samples.~        -  Phase 1A/1B: Participants will have a 3-day inpatient study visit with the following~          procedures:~        -  Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a~          special diet for the next day s test.~        -  Gastric analysis using a nasogastric tube to collect stomach acid secretions.~        -  SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24~          to 48 hours to collect readings.~        -  Participants in Phase 1A will have a second outpatient SmartPill study 7 days after the~          first SmartPill study. Participants in Phase 1B will not have the second SmartPill~          study.~        -  Phase 2 and Phase 3: Participants will have a 3-day inpatient study visit with the~          following procedures:~        -  Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a~          special diet for the next day s test.~        -  Gastric analysis using a nasogastric tube to collect stomach acid secretions.~        -  SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24~          to 48 hours to collect readings.~        -  Phase 2 and 3 participants will have outpatient study visits only if directed by the~          study researchers.~   "
218241|NCT00702520|"~     The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286)~     treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian~     Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection~     (ICSI) is safe for pregnant participants and their offspring.~   "
218242|NCT00702507|"~     The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate~     ointment in newborns and infants with a yeast infection in the diaper area causes the yeast~     to become resistant to the drug.~   "
218243|NCT00702494|"~     TB-403 is a monoclonal antibody directed against Placental Growth Factor (PlGF). The antibody~     binds to PlGF and inhibits the binding to it's receptor, VEGF-1. By preventing this binding,~     growth of tumor vessels are inhibited and tumor growth prevented.~      In this study we are investigating the tolerability and safety of TB-403 in patients with~     solid tumors who receives multiple intravenous doses of TB-403.~   "
218244|NCT00702481|"~     The purpose of this study is to define the response and toxicities with the addition of~     Nimotuzumab to chemoradiation for head and neck cancer.~   "
218245|NCT00702468|"~     The purpose of this study is to evaluate the maintenance of effect after long-term treatment~     with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have~     been receiving long-term benefit from treatment with Sativex®.~   "
218246|NCT00702455|"~     The goal of this project is to test whether a phone and mail-based program designed to help~     people who have recently lost weight helps them keep the weight off over a 2 year period.~   "
218247|NCT00702442|"~     Protocol title: Role of low dose droperidol in postoperative vomiting~      Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when~     administrated at the introduction to anesthesia, prior to surgery~      Design: Prospective, randomized, placebo-controlled study~      Patient Population: Male or female subjects 18 years of age or older who are scheduled for~     laparoscopic cholecystectomy~      No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll~      Duration of Treatment: Prior operation~      Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively~      Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior~     surgery~   "
218248|NCT00702429|"~     Our design is to test in hospital practice a selection of immune parameters that could assess~     the pathophysiology and progression of periodontal lesions.~   "
218249|NCT00702416|"~     This study has been designed to assess the possible advantages of using ultrasound imaging to~     block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder~     surgery.~      The ultrasound technique will be compared with the current gold standard, electrical nerve~     stimulation.~      The aim of this study is to define which technique is better in terms of time to onset of~     anesthesia.~   "
218250|NCT00702403|"~     This phase I/II trial is studying the side effects and best way to give nilotinib when given~     alone or sequentially after imatinib mesylate after donor stem cell transplant in treating~     patients with acute lymphoblastic leukemia or chronic myelogenous leukemia. Nilotinib and~     imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~   "
218251|NCT00702377|"~     To evaluate the safety and efficacy of two artificial tears in dry eye patients.~   "
218252|NCT00702364|"~     Atomoxetine is the only medication that is currently approved by the FDA for the treatment of~     attention deficit hyperactivity disorder in adults. It has gained recent interest as an~     alternative medication for treating attentional problems related to traumatic brain injury~     (TBI), but it's effectiveness in this population has not been studied. There are a number of~     advantages of Atomoxetine over traditional neuro-stimulant medications currently used for~     attentional disorders after traumatic brain injury. This study will use a randomized~     double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine~     to improve attention, behavioral function, and depression in adults with TBI~   "
218253|NCT00702351|"~     To evaluate the induction of multiple follicular growth after single dose administration of~     100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.~   "
218254|NCT00702338|"~     The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org~     36286) treatment for the induction of monofollicular growth in women who underwent ovulation~     induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their~     offspring.~   "
218255|NCT00702325|"~     To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to~     that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African~     American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.~   "
218256|NCT00702312|"~     The aim of this study is to assess the benefits of using low-salt and healthy eating~     educational programme, designed specifically for Bangladeshi kidney patients, compared to the~     usual diet advice given by the clinic dietitians.~   "
218257|NCT00702299|"~     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving pemetrexed together with cisplatin and paclitaxel and giving them~     in different ways may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal~     pemetrexed when given together with intraperitoneal cisplatin and paclitaxel in treating~     patients with stage III ovarian epithelial cancer, primary peritoneal cancer, or fallopian~     tube cancer.~   "
218258|NCT00702286|"~     Catheter associated urinary tract infection is one of the most common types of catheter~     acquired infections and adds greatly to patient morbidity, mortality and medical cost.~     Urinary catheters may readily acquire biofilms when inserted. The longer the catheter remains~     in place, the greater the tendency of these organisms to develop biofilms and result in~     urinary tract infections, which are difficult to treathe UroShield System is intended to~     prevent bacterial biofilm formation by means of the Active NanoShield technology it has~     developed. A number of scientific concepts and principles shown in prior studies have shown~     some promising results in the treatment of biofilm based sequele using ultrasound energy. The~     NanoShield technological basis of the UroShield System has taken these concepts to a level~     where acoustical waves in the ultrasound range can be created by low cost disposable~     actuators which actually create a physical coating on all of the surfaces of the catheter~     thereby interfering with the attachment of bacteria which is the initial step in biofilm~     formation.~   "
218259|NCT00702273|"~     To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are~     cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the~     cumulative pregnancy rate for each treatment group.~   "
218260|NCT00702260|"~     The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under~     fed conditions.~   "
218261|NCT00702247|"~     To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant~     approach in newly diagnose myeloma patients younger than 65 years~   "
218262|NCT00702234|"~     The objective of this trial is to evaluate whether corifollitropin alfa (Org 36286) treatment~     for the induction of multifollicular growth in women undergoing controlled ovarian~     stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection~     (ICSI) is safe for pregnant participants and their offspring. In addition, a primary efficacy~     variable, live birth rate, was evaluated.~   "
218263|NCT00702221|"~     Angiotensin Therapeutic Vaccine (ATV), which contains the novel adjuvant, CoVaccine HT™ , is~     being developed for the treatment of high blood pressure (hypertension), a major risk factor~     for serious diseases such as heart attacks and strokes. Many patients with high blood~     pressure fail to take their medicines as prescribed because they generally feel well, which~     often results in poor control of the condition. As a result, it is estimated that about 70%~     patients with hypertension do not have their blood pressure adequately controlled despite~     advances in the treatment of high blood pressure.~      The main aim of this study is to find out if an injection of ATV given in the arm once every~     3 weeks on 3 occasions results in lowering overall blood pressure measurements throughout the~     day. The other aims are to find out if ATV is safe and to see how well it is tolerated~   "
218277|NCT00702039|"~     Multiple studies in various specialties, including ophthalmology, are reported in the~     literature that show that playing music during a procedure (dubbed music therapy) increases~     patient satisfaction and may reduce patient anxiety and stress levels.~      There is no study in the literature that assesses the effects of listening to music in~     patients undergoing intravitreal injections. This study aims to assess whether listening to~     music improves patient satisfaction or reduces their anxiety levels in subjects undergoing~     intravitreal injections.~   "
218264|NCT00702208|"~     The aim of this study is to see whether a new self-sampling device, the Delphi Screener~     (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The~     results using the new device will be compared to results using the current gold standard. The~     gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often~     referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of~     using the device and how easy it is to understand the user instructions.~      The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline~     which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is~     that the device may work well for cervical cytology and will be acceptable to the women in~     the study.~   "
218265|NCT00702195|"~     The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa~     clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment~     programs was safe for pregnant subjects and their offspring. Data from subjects who~     participated in Trials 38805 and 38807 and became pregnant were evaluated.~   "
218266|NCT00702182|"~     The purpose of this study is to define the schedule and dose of oral vinorelbine (Navelbine)~     to be used with erlotinib in non-small cell lung cancer.~   "
218267|NCT00702169|"~     Background: Patients that suffer from respiratory failure and need mechanical ventilation are~     at risk of further deterioration due to complications induced by progression of lung disease~     or the mechanical ventilation. The complications usually develop in a progressive manner, but~     are currently detected relatively late, when there is already severe and life threatening~     deterioration in patient oxygenation and sometimes irreversible damages.~      Objective:To measure chest wall dynamics, derived from sensors placed on the chest and~     abdomen.~      Methods: The system comprises of patches attached to the chest wall and upper abdomen that~     include mechanical sensors that measure the mechanics of lung inflation and deflation.~   "
218268|NCT00702156|"~     The principal research objectives are to demonstrate cardioselective beta-blockade using~     bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality~     of life in patients with heart failure and coexistent moderate or severe chronic obstructive~     pulmonary disease with or without significant reversibility. Patients will be followed up for~     4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated~     dose. Health status will be assessed using a generic and two disease specific questionnaires,~     and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise~     testing.~   "
218269|NCT00702143|"~     Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy~     control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment~     (MCI).~   "
218270|NCT00702130|"~     Statins present anti-inflammatory and immunomodulatory effects. They may modify the~     regulation of cytokines, (released from the cellular damage) and may reduce the production of~     C-reactive protein levels. It has been hypothesized that these pleiotropic characteristic of~     statins might be useful in the management of various diseases, including pneumonia. Indeed, a~     recent study showed that statin treatment is associated with reduced risk of pneumonia in~     diabetic patients. However, the relationship between statins and reduced risk of pneumonia is~     not consistent . In addition there is no prospective study to investigate the role of statins~     in severe forms of pneumonia such as the VAP.~      On this base the investigators aim to study prospectively the effect of statins on the~     outcome of patients with VAP in the ICU settings. The investigators therefore contacted a~     double open label randomized trial to investigate whether the use of pravastatin reduces the~     incidence of Ventilator Associated Pneumonia in the ICU and whether it is related with~     favorable outcome of patients with Ventilator Associated Pneumonia.~   "
218271|NCT00702117|"~     The study evaluates 3 different populations:~      It is an open, randomized, parallel-group study comparing the effectiveness of intravenous~     (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :~        1. recent-onset atrial fibrillation versus iv flecainide~        2. sustained monomorphous ventricular tachycardia versus iv procainamide~      The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline~     versus iv flecainide in the diagnosis of Brugada syndrome~   "
218272|NCT00702104|"~     RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to~     treat.~      PURPOSE: This research study is looking at whether patients who are being screened for~     prostate cancer have been previously screened.~   "
218273|NCT00702091|"~     The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under~     fasting conditions.~   "
218274|NCT00702078|"~     We want to improve the treatment of patients suffering from COPD (3-4) by early medical~     intervention in the patients home. A close cooperation between the hospital and the primary~     healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality~     of life. Following up from the hospital and the primary healthcare in cooperation may lead to~     earlier detection and treatment of exacerbations in COPD.~      The main outcome variable will be number of hospitalizations assessed simply by counting. The~     second objective will be Quality of life and activation assessed by different questionnaires~     included in St.George´s Respiratory Questionnaire.~   "
218275|NCT00702065|"~     This is a multi-center, multi-regional observational,24 month study.~      Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be~     collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health~     outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.~   "
218276|NCT00702052|"~     This study is to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in~     patients with Mantle Cell Lymphoma who are refractory or intolerant to Velcade® therapy and~     who have received at least one prior antineoplastic agent other than Velcade®, either~     separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade®~     therapy is determined by the study investigator based on clinical evaluations. Patients are~     considered refractory to Velcade® if they have documented radiological progression on or~     within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of~     the last dose of the last component of a combination therapy which included Velcade®.~   "
218748|NCT00695786|"~     The goal of this clinical research study is to learn if revlimid (lenalidomide) in~     combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma can~     control the disease. The safety of this combination will also be studied.~   "
218278|NCT00702026|"~     The purpose of this study is to determine whether a specifically designed multispecies~     probiotic decreases visceral hypersensitivity in IBS-patient (defined by an increased pain~     tolerance threshold). Moreover, the effect on general symptom scores and inflammatory and~     microbiological parameters will be studied.~   "
218279|NCT00702013|"~     The P-glycoprotein (P-gp) is a membranous transporter that modulates the intracellular~     concentrations of many drugs and plays thus a major role in the efficacy of the therapeutics~     that act within the lymphocytes, such as antiretroviral drugs. We aim at studying the~     evolution of this transporter's expression and activity on lymphocytes in relation with the~     human development from newborns to adults. We also aim at studying the influence of HIV and~     antiretroviral treatments on this transporter, especially anti-protease drugs, within the~     children population.~   "
218280|NCT00702000|"~     To better understand ICU-acquired weakness in patients requiring mechanical ventilation in~     the Intensive Care Unit.~   "
218281|NCT00701987|"~     A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four~     weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic~     melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on~     histological remission of cutaneous metastatic melanoma and induction of apoptotic~     biomarkers.~   "
218282|NCT00701974|"~     Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous~     tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that~     heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin~     ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are~     from other causes.~      Clinical studies show that collagenase is an effective drug and presents high tolerabildade~     in the treatment of ulcerative burns and injuries of various etiologies. Evidence show~     statistically significant reduction of inflammation, the formation of granulation tissue,~     decrease in injuries and reepitelization.~   "
218283|NCT00701961|"~     Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past~     decades, P. falciparum has shown increasing resistance to chloroquine and~     Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin~     containing combination therapies (ACTs) are now the standard treatment of P. falciparum~     malaria in areas with established resistance to traditional therapies. However, a standard~     approach for using ACT in pregnancy does not exist in Africa, where some countries keep on~     using quinine, while others allow the use of ACTs. Thus, there is need of establishing the~     safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of~     antimalarials may be altered during pregnancy and since available pharmacokinetic data are~     still somewhat limited, we propose to carry out a study confirming or disproving existing~     pharmacokinetic data (collected in South-East Asia), before starting any larger African~     efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS),~     developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which~     will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women~     in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched~     non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.~   "
218284|NCT00701948|"~     This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers~     for the diagnosis of nosocomial bacterial infection. We made the hypothesis that these new~     dosages or new inflammatory markers could be more useful than dosage of inflammatory markers~     already used in clinical practice (especially the use of a combination of interleukins (6 or~     8) and C-reactive protein for the management of newborns with a clinical suspicion of~     nosocomial bacterial infection and especially could allow to avoid excessive treatment with~     antibiotics~   "
218285|NCT00701935|"~     A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of~     twice-daily subcutaneous injection with exenatide versus treatment with matching placebo~     injection on abdominal visceral fat content.~   "
218286|NCT00701922|"~     The present study was conducted to study the impact community acquired respiratory virus~     (CARV) infections in an outpatient setting on graft function of lung transplant recipients.~     The study was aimed to identify risk factors for CARV infections.~      The study was further intended to investigate an association of Epstein-Barr virus (EBV),~     cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify~     risk factors for virus detection in blood.~   "
218287|NCT00701909|"~     This is a randomized double-blind study to determine if the administration of a small-dose of~     ketamine (an anesthetic)added to morphine (an opioid) contributes to reducing pain intensity~     during open wound care procedure (WCP)in patients who have had a traumatic injury and are in~     an Intensive Care Unit. Patients will be randomized to receive morphine plus saline (a~     placebo) or morphine plus ketamine before the WCP. The second time the patient is scheduled~     for WCP (no less than 24 hours), patients will be crossed over to receive the treatment they~     did not receive the first time. It is hypothesized that patients who receive the combination~     of morphine and ketamine will have better pain control during the procedure than patients who~     just receive morphine.~   "
218288|NCT00701896|"~     People that are infected with HIV appear to be especially susceptible to the adverse effects~     of cigarette smoking. The purpose of this study is to determine if quitting smoking by using~     a specialized smoking cessation treatment can prevent one from developing accelerated lung~     damage, particularly emphysema.~   "
218301|NCT00701727|"~     This is a prospective, placebo-controlled, cross-over trial comparing the the effects of~     approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) treatment on~     several parameters of reverse cholesterol transport (RCT) in men and post-menopausal women~     diagnosed with hypercholesterolemia. The primary hypothesis is that the ezetimibe treatment~     will increase the excretion of endogenous (plasma-derived) cholesterol as fecal sterols, with~     secondary hypotheses that there will be a significant increase in de novo cholesterol~     synthesis, treatment will increase cholesterol efflux from tissues into the bloodstream, and~     increase global RCT.~   "
218302|NCT00701714|"~     This is a randomized, controlled, double-blind, multicenter multinational safety study~     involving about 300 predialysis patients aged 18 years or above suffering from anemia.~      Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to~     achieve a hemoglobin target range of 10.0 -12.0 g/dL.~   "
218289|NCT00701883|"~     A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy,~     safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin~     resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in~     combination with Atorvastatin~      Total participation for each patient is approximately 16-17 weeks, which may include up to a~     2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up.~     During the run-in period patients taking statins, statin combination or Zetia will undergo a~     'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their~     same diet prior to entering the study). They will be asked to defer initiating any weight~     loss diets or meaningful changes in their activity level until after they have completed the~     study. Once randomized into the double blind study, patients will visit the clinic every two~     weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the~     double-blind study medication will be discontinued. Patients will attend a follow up visit~     two weeks after their final dose for safety evaluation.~   "
218290|NCT00701870|"~     TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra~     treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung~     cancer receiving first‑line therapy with carboplatin and docetaxel.~   "
218291|NCT00701857|"~     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may make~     tumor cells more sensitive to radiation therapy. Giving pemetrexed together with cisplatin~     and radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when~     given together with cisplatin and radiation therapy in treating patients with stage III or~     stage IV esophageal cancer or gastroesophageal junction cancer.~   "
218292|NCT00701844|"~     The Sharing Our Strength study is being conducted to help us understand people's experiences~     with hematopoietic stem cell transplantation and to test a new program designed to help~     people recover physically and emotionally after transplant.~   "
218293|NCT00701831|"~     Primary objective:~        -  To observe the efficacy of the forced titration to reach good glycemic control in Lantus~          treated patients~      Secondary objectives:~        -  To assess the forced titration on physician and patient satisfaction~        -  To evaluate the impact of training tools by means of patient profile~   "
218294|NCT00701818|"~     The specific objectives of this thesis are in a cohort of patients with an acute ischemic~     stroke,~        1. To establish the degree of coronary arteriosclerosis.~        2. To describe left ventricular systolic and diastolic function in relation to changes of~          NT-proBNP.~   "
218295|NCT00701805|"~     The purpose of this study is to evaluate the long-term safety of paricalcitol injection.~     Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in~     dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309~     (NCT00667576).~   "
218296|NCT00701792|"~     Liver transplantation has been universally recognized to improve survival of patients~     suffering from end-stage (Pugh C) alcoholic cirrhosis. However, for Pugh B patients, the~     benefit of liver transplantation remains to be demonstrated. The aim of the present study was~     to compare the outcome of Pugh B patients with alcoholic cirrhosis randomly assigned for~     immediate liver transplantation (group 1) or standard treatments (group 2).~   "
218297|NCT00701779|"~     This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg),~     administered once daily for one year in combination with Tamsulosin (0.4mg), administered~     once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as~     needed basis, on the improvement of symptoms and clinical outcome in men with moderate to~     severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9~     months), the subject will be counseled on withdrawal of Tamsulosin. After randomization,~     study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic~     visits)~   "
218298|NCT00701766|"~     The present trial will be performed to determine the MTD and to evaluate the efficacy of BI~     2536 in the treatment of elderly patients with relapsed or refractory AML. Different~     schedules will be compared to identify the better dosing schedule for the further development~     programme of BI 2536. Dose escalation starting with the maximum tolerated dose previously~     determined in patients with advanced solid cancers will be performed to determine the maximum~     tolerated dose for AML patients.~   "
218299|NCT00701753|"~     An individual's genetic make-up is known to determine their response to antipsychotic~     medication. Genetic markers that determine efficacy and side effects of medication may be~     identified and used to predict treatment outcome.~      The study is a naturalistic study of routinely prescribed antipsychotics using outcome~     measures undertaken as part of the routine clinical care of the cohort. These clinical data~     are linked with genetic information obtained from DNA and RNA from blood samples undertaken~     as part of the study.~      No alteration is made to the subjects treatment regime or medication.~      The study is a two stage investigation:~        -  The first stage involves the collection of a databank of clinical information and blood~          samples for DNA and RNA extraction from patients treated with antipsychotic medication.~        -  The second stage is a molecular genetic investigation of treatment-related genetic~          factors that may contribute to response prediction and predisposition to side effects.~      From these genetic studies pharmacogenetic prediction tests will be validated and/or~     developed.~   "
218300|NCT00701740|"~     A clinical and histological randomized controlled phase II trial to evaluate the efficacy and~     safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or~     sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A-~     21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three~     months; B- 11 women received only same moisturizer/sunscreen.~   "
218368|NCT00700843|"~     Obtain long-term follow-up results for bariatric patients who underwent medical management or~     surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC).~   "
218369|NCT00700830|"~     This study is conducted in Africa. The aim of this study is to assess the safety and efficacy~     of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical~     practice conditions in Algeria.~   "
218303|NCT00701701|"~     An exploratory, open-labeled study of patients with Pompe disease, who have previously~     received Myozyme (alglucosidase alfa) treatment, to evaluate the efficacy, safety and~     clinical benefit of 2 Immune Tolerance Induction (ITI) regimens in combination with Myozyme.~     Eligible patients who are currently receiving Myozyme therapy will be enrolled into the~     study, and will be followed for a minimum of 18 months on-study (a 6-month ITI treatment~     module and a 12-month follow-up module on Myozyme alone). Eligible patients will be followed~     for a minimum of 18 months on treatment or, if a patient is <6 months of age at the time of~     enrollment, until the patient is 2 years of age. Both cross-reacting immunologic material~     (CRIM)-negative and CRIM-positive patients can be eligible for Regimen A depending if they~     meet the required criteria. Regimen B however, is limited to CRIM-negative patients.~   "
218304|NCT00701688|"~     Mucositis is a well-known complication of both autologous and allogeneic hematopoietic stem~     cell transplantation (HSCT). Many who suffer this disorder require total parental nutrition~     and intravenous narcotics for pain control. Palifermin (Kepivance[TM]) is a human~     keratinocyte growth factor that is produced by recombinant DNA technology in E. coli.~     Palifermin is a FDA-approved, commercially available pharmacologic agent that is manufactured~     by Amgen. As keratinocyte growth factor receptors have been found within the epithelium of~     gastric mucosa, the use of palifermin has been proven to decrease the frequency and duration~     of severe mucositis in adult studies. Whereas the appropriate dosing regimen has been~     determined for adults at 60mcg/kg/day, the dosing of palifermin has not been established in~     the pediatric setting. This initial pediatric study of palifermin will determine the maximum~     tolerated dose, evaluating the use of this agent at three dose levels, below, at, and above~     the recommended adult dose. Non-hematologic, life-threatening NCI grade IV or grade V~     toxicities definitely related to the administration of palifermin from the first infusion~     until day +6 after HSCT (post palifermin administration day +3) will comprise the safety~     endpoints of the study.~      The study is designed to evaluate palifermin at 3 dose levels. The study population will be~     recipients of either a matched family member donor or matched unrelated donor HSCT. The~     pharmacokinetics of palifermin at each dose level will be described to help determine the~     appropriate dose for future studies, which will evaluate efficacy~   "
218305|NCT00701675|"~     Generalized anxiety disorder (GAD) is a very common disorder in the geriatric population with~     prevalence rates reaching 7% and even higher rates of 8% among elderly veterans. However,~     despite such high prevalence treating clinicians are presently forced to address treatment~     issues in this population without the guidance of scientific data. This proposal aims to~     begin to address this void.~      In light of emerging information regarding efficacy of the newer anti anxiety agents,~     specifically the selective serotonin reuptake inhibitors (SSRIs), in the treatment of young~     adult GAD patients it is time to prospectively evaluate the safety and efficacy of these~     medications in the treatment of elderly GAD patients. Therefore, this study will examine the~     effects and safety of the SSRI sertraline at different doses (50mg and 100mg per day) for~     older patients with GAD.~   "
218306|NCT00701662|"~     The objective of this study is to assess efficacy, safety, and convenience of purified human~     antibodies administered under the skin in the treatment of MMN patients.~   "
218307|NCT00701649|"~     CYT006-AngQb is a vaccine that induces a B-cell mediated immune response characterized by the~     generation of specific antibodies (IgG and IgM) against Angiotensin II. The vaccine is~     administered by subcutaneous injection.~      The objectives of the study are:~        -  To evaluate safety and tolerability of 5 s.c. injections of 300µg CYT006-AngQb with~          Alhydrogel™ in patients with mild to moderate essential hypertension (hypertension Grade~          I and II).~        -  To assess pharmacodynamic effects, i.e. anti-Ang II immune response and renin-~          angiotensin system (RAS) biomarkers.~        -  To explore the effect on blood pressure using ABPM.~   "
218308|NCT00701636|"~     This investigation is a prospective, open-label pharmacokinetic study of daptomycin~     prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular~     replacement.~   "
218309|NCT00701623|"~     Burns are injuries caused by agents thermal, chemical, electrical or radioactive who act in~     the tissue lining of the human body and may partially or totally destroy the skin and its~     annexes, to the deeper layers, as subcutaneous tissue, muscles, tendons and bones .~      Studies show that topical heparin has, in addition to the already known anticoagulant~     activity, anti-inflammatory properties, analgesic, and neoangiogenic, stimulating blood flow~     and increasing the repair of the fabric as well as the restoration of collagen and~     reepiteliztion. Moreover, the use of heparin reduces the need for painful medical procedures,~     as debridations, surgeries and transplants The intention of this work is to verify the~     effectiveness and safety of sodium heparin in the treatment of burns of the skin.~   "
218310|NCT00701610|"~     Von Willebramd Factor (VWF) is an adhesive glycoprotein synthesized by megakaryocytes and~     endothelial cells.VWF has a central role in primary hemostasis and is a critical ligand for~     platelets adhesion and aggregation (1, 2).VWF is the carrier of circulating factor 8 as well.~     VWF is stored in Wiebel-Palade bodies in endothelial cells and in platelets alfa granules in~     a form of Ultra-large (UL) multimers.~      The VWF multimers are composed from subunits which are linked by disulfide bonds that~     alternate between 2 C- terminal ends and 2 N- terminal ends in a head-to-head and~     tail-to-tail fashion (3, 4). The biological activity of VWF has been shown to be related to~     the size of the multimers.~      VWF is released from endothelial cells toward the plasma as a multimers ranging from~     500-20,000 kD. The UL multimers are hemostaticallly more effective than the smaller forms.~     They spontaneously bind to platelets which lead to the formation of microthrombi in the~     circulation. This mechanism is downregulated by the plasma protease ADAMTS-13(A Disintegrin~     And Metalloprotease with ThromboSpondin motif).If the proteolysis become defective the ULVWF~     will bind to platlets resulting in systemic thrombotic microangiophaties (TMA) such as~     thrombotic thrombocytopenic purpura(TTP)(5,6).~      ADAMTS-13 belongs to the ADAMTS family of metalloproteases.The structure of ADAMTS-13 is~     conserved throughout vertebrates, indicating its important function (7).The metalloprotease~     function was first describe 11 years ago and has been cloned and characterized (8-13).The~     ADAMTS family of metaloploproteases is required in other systems such as genitourinary system~     (ADAMTS1), collagen system (ADAMTS2) and as a cleaving protease of VWF (VWFCP) - ADAMTS13.~     When VWF multimer is subjected to sufficient fluid shear stress ADAMTS-13 cleaves VWF at a~     unique 842Tyr- 843Met bond in domain A2 (14,15).This cleavage produce VWF subunit fragments~     of 176 kDa and 140 kDa.~      The activity of ADAMTS-13 depends on both Zn+2 and Ca+2 ions (16). Low levels or deficiency~     of ADAMTS-13 is seen in patient with TTP(17,18). Mannuccio et al (19) showed that low levels~     of ADAMTS-13 are seen in other conditions such as healthy adults older than 65 years,~     patients with cirrhosis, uremia, acute inflammation, postoperative period. In neonate and~     preterm infants the data is limited. Few studies have shown that levels of ADAMTS-13 are low~     in neonate (19-21).Tsai et al (22) observed that ADAMTS-13 activity is normal in cord blood~     compared to adults. In preterm infants a pilot study showed that preterm have low levels of~     ADAMTS-13(23).~      The aim of our study is to check ADAMTS-13, VWF multimers, VWF antigen and VWF collagen~     binding activity in healthy and sick neonate and in preterm infants.~   "
251001|NCT00266591|"~     The purpose of this study is to evaluate the effectiveness and safety of topiramate (an~     antiepileptic medication) in patients with epilepsy.~   "
218311|NCT00701597|"~     Several lines of evidence suggest now that ocular perfusion abnormalities may contribute to~     the progression of glaucoma. It has been hypothesised that increased endothelin-1 plasma~     levels, as seen in patients with glaucoma, may be related to these alterations in ocular~     blood flow. We could show in recent experiments that administration of ET-1 decreases ocular~     blood flow, whereas blocking of the ET-A receptors do not affect basal vascular tone in~     healthy subjects. In the current study we set out to evaluate the effect Bosentan, a~     non-selective ETA-receptor antagonist in patients with open-angle glaucoma. This should allow~     us to test the hypothesis that administration of an ET-1 receptor antagonist increases ocular~     blood flow in patients with glaucoma.~      Investigations will be done with a retinal vessel analyzer to determine retinal vessel~     cross-sectional diameters, with laser Doppler flowmetry and laser Doppler velocimetry to~     determine subfoveal macular blood flow and optic nerve head blood flow and with laser~     interferometric measurements to determine fundus pulsation amplitude in the macula. The~     intraocular pressure will be measured with applanation tonometry. This will be assessed at~     baseline and in response to peroral application of Bosentan or placebo.~      The study objective is therefor, to evaluate the contribution of ET-1 to ocular blood flow~     dysregulation in patients with open-angle glaucoma.~   "
218312|NCT00701584|"~     Diet has been found to influence hormone production and metabolism which in turn could affect~     the incidence of hormone related cancers. Consumption of soy-containing foods, known to be~     rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast~     cancer in Asian populations. Phytoestrogens have a wide range of metabolic effects and may~     have a role in effecting breast cancer risk. Although there is mounting evidence of the~     positive influence of phytoestrogens on breast cancer risk, very little research has been~     carried out in humans as to the effects of phytoestrogens on breast cancer recurrence and~     survival. The DietCompLyf study aims to explore this effect by carrying out an observational~     study in 3,000 breast cancer women in the UK. The effects of diet, lifestyle practices and~     use of complementary treatments will also be investigated. Participants are recruited 9-15~     months post-diagnosis and followed up for 5 years. Questionnaires as well as blood and urine~     samples are collected annually.~   "
218313|NCT00701571|"~     The purpose of this study is to compare the analgesic efficacy of three different types of~     video/audio distraction in normal volunteers subjected to carefully controlled and~     non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of~     a lumbar puncture. Two of the distraction techniques include immersive virtual reality (VR).~     The most efficacious distraction technique will be used in a subsequent clinical study in~     cancer patients.~   "
218314|NCT00701558|"~     This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in~     chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell~     lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination~     with gemcitabine 1000 mg/m^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The~     anticipated time on study treatment is until disease progression, and the target sample size~     is <100 individuals.~   "
218315|NCT00701545|"~     As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low~     volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective,~     multi-center structured data collection of routine management of patients with von Willebrand~     disease treated with Humate P® ivr in Canada. The surveillance will be non-interventional and~     non-experimental. During the observation period, the routine medical care of the patient will~     be documented.~      It is expected that there will be no difference in the safety and tolerability of Humate-P®~     ivr compared to Humate-P®~   "
218316|NCT00701532|"~     -Context: Study objectives Primary: impact of modafinil versus placebo on DAT density~     modifications in the striatal and extra-striatal regions in cocaine dependent subjects~     hospitalised from D3 to D21.~      Primary Hypothesis:~      More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo~     from D3 to D21 during cocaine detoxification.~   "
218317|NCT00701519|"~     OSA is associated with large negative swings in the intrathoracic pressure, significant~     increase in the sympathetic nerve activity and repetitive surges in blood pressure, along~     with episodic hypoxia and hypercapnea (8,9). These autonomic and respiratory changes may~     increase the cardiac muscle workload, cardiac dysrrhythmia, and exacerbate ischemia~     (10,11,12). Treatment with CPAP is the most successful therapeutic modality available for~     OSA. It is still not clear whether establishing the diagnosis of OSA and initiating treatment~     with CPAP while still in the hospital carries any benefit in the management of patients with~     acute heart failure. This study will evaluate the effect of work up and treatment of OSA on~     the outcome of patients hospitalized with acute CHF.~   "
218318|NCT00701506|"~     The purpose of the study is to investigate the benefits of the Patterned Neuromuscular~     Electrical Stimulation (PENS) for the treatment of osteoarthritis. The rationale for this~     investigation is to assess the benefit of PENS in the alleviation of symptoms of~     osteoarthritis and elucidating the mechanism of action of PENS.~   "
218319|NCT00701493|"~     The primary purpose of this study is to estimate the bioavailability of the oral liquid~     formulation of topiramate relative to the commercially available oral sprinkle capsule~     formulation in healthy patients. If appropriate, bioequivalence between the oral liquid~     formulation and the sprinkle capsule formulation will be assessed.~   "
218320|NCT00701480|"~     Skin cleanser for daily used is essential and one of the most common questions asked by acne~     patients. There are studies reported beneficial effects of cleansers in acne treatment.~     Extracts of plants as active ingredients in skin cleansers are increasingly popular~     worldwide. Roselle is a common tropical shrub. Usually, the calyces of the plant have been~     used to make beverages but it also used in Thai traditional medicine for several purposes~     including as antiseptic and astringent. The extract of roselle showed antioxidant and~     keratolytic effects from previous studies which fit to the pathogenesis of acne. The aims of~     the study is to determine the safety and efficacy of skin cleanser contained roselle extract~     in acne.~   "
218321|NCT00701467|"~     To investigate changes in HRV during the time before a spontaneous episode of ventricular~     tachyarrhythmia.~   "
218322|NCT00701454|"~     The purpose of this study was to determine the prevalence and risk factors of diabetes,~     hypertension, hyperlipidemia among Thai muslim population aged 35-75 years.~   "
218323|NCT00701441|"~     Obstructive Sleep Apnea (OSA) is the most common sleep disorder affecting up to 9-24 percent~     of middle aged adults, and is becoming increasingly implicated in the pathogenesis of~     hypertension, and other cardiovascular disorders. Up to half of patients with OSA have~     hypertension, and their risk of developing hypertension increases with the increasing~     severity of Sleep Apnea. Patients with OSA and no hypertension have endothelial dysfunction,~     which is believed to be the precursor for most cardiovascular disorders.~      The upper airway collapse and obstruction that occur in OSA result in a pattern of~     intermittent hypoxia, that has been shown to be the cause of the hypertension, and~     endothelial dysfunction found in patients with OSA. Intermittent hypoxia results in oxidative~     stress, which in turn is linked to the pathogenesis of hypertension and endothelial~     dysfunction.~      This protocol evaluates the role of the oxidative stress in endothelial function and blood~     pressure in patients with OSA. This is a pilot clinical study that will compare oxidative~     stress parameters, and endothelial function in patients with OSA before starting treatment~     with continuous positive airway pressure (CPAP) and 12 weeks post being on CPAP. These~     patients will be compared to control patients with no history of OSA. the study does not~     involve assignement to different treatments. All patients will receive the indicated~     treatment for OSA and measurements will be collected before and 12 weeks after adequate~     treatment.~   "
218324|NCT00701428|"~     Obstructive sleep apnea (OSA) is a highly prevalent condition in hypertensive patients. The~     renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An~     angiotensin-II-antagonist, Losartan, is an effective antihypertensive drug. However, some~     patients respond to this drug worse than the others, and it is a clinical praxis to either~     increase the dosage and/or add another drug. There is limited data regarding the impact of~     antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup~     of therapy-resistent hypertensive patients. In the literature, there is no data, either,~     whether or not CPAP treatment may have an additive blood pressure lowering impact in this~     certain subgroup.~   "
218325|NCT00701415|"~     The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme~     (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in~     treatment-naïve pediatric participants without severe symptoms. Participants were to be~     treated for 5 years.~   "
218326|NCT00701402|"~     The purpose of this observational study is to describe the time to lipid-lowering drug~     implementation in the management of dyslipidemic patients, according to the cardiovascular~     risk level.~   "
218327|NCT00701389|"~     Study to understand the effects of migraine treatments on blood pressure in participants with~     migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure~     following the coadministration of telcagepant and sumatriptan is similar to that following~     administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan~     with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours~     following dosing is less than 5 mmHg.~   "
218328|NCT00701376|"~     Liver disease in the morbidly obese is thought to occur due to the long-term presence of fat~     deposits in the liver, resulting in inflammation and scarring of the liver over time, which~     reduces liver function. However, many of these patients are unaware that their liver is~     damaged. There is currently no consensus regarding what the long-term effects of gastric~     bypass surgery are on pre-existing liver disease in morbidly obese patients. This study will~     determine the long-term effects on the liver after this type of surgical procedure.~   "
218329|NCT00701363|"~     The purpose of the study is to assess the efficacy of an extended injection interval schedule~     of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long~     term treatment with octreotide LAR 10 or 20 mg~   "
218330|NCT00701350|"~     The purpose of this study is to investigate the expression of protein biomarkers in cervical~     vaginal fluid in women with preterm premature rupture of membranes (PPROM)~   "
218331|NCT00701337|"~     The aim of this pilot study conducted in post-menopausal women is to evaluate the effect of~     17ß-estradiol administration on inflammatory-immune cells, namely antigen-presenting cells~     (monocytes/dendritic cells), and more precisely on their activation by inflammatory stimuli.~     This study will allow us to determine our ability to recruit menopausal women and to~     characterize the optimal primary end-point among the numerous criteria tested~   "
218332|NCT00701324|"~     The main objective of this trial is to provide safety data in terms of drug-related adverse~     events (AE) for the recommendation of the dose for further trials in the development of BI~     811283.~      Secondary objectives are the collection of antitumour efficacy data and the determination of~     the pharmacokinetic profile of BI 811283.~   "
218333|NCT00701311|"~     Prostatitis is the most common urologic diagnosis in men under the age of 50 and the third~     most common diagnosis in older men. In Chronic Prostatitis (CP) or Chronic Pelvic Pain~     Syndrome (CPPS), men have lower urinary tract symptoms, pelvic pain, sexual dysfunction and~     decreased quality of life. Little is known about the cause of CP/CPPS. Likewise, no~     definitive therapy exists for CP/CPPS. We plan to study the use of CC-10004 in men with~     CP/CPPS.~   "
218334|NCT00701298|"~     This phase I trial is studying the side effects of decitabine when given together with or~     without interferon alfa-2b, and the best dose of interferon alfa-2b, in treating patients~     with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as decitabine,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Biological therapies, such as interferon alfa-2b, may stimulate~     the immune system in different ways and stop tumor cells from growing. It is not yet known~     whether decitabine is more effective when given with or without interferon alfa-2b in~     treating solid tumors.~   "
218335|NCT00701285|"~     We want to evaluate the utility of statins on heart function according to potency. Patients~     with chronic ischemic heart failure are administered pitavastatin 4mg or pravastatin 10mg for~     52 weeks. Then we evaluate the effect of pitavastatin and pravastatin primarily on rate of~     hospitalization for cardiovascular cause and lipid profile secondarily biomarker,~     echocardiography parameter, 6-minute walk, change of NYHA class distribution, cardiovascular~     mortality.~   "
218390|NCT00700557|"~     The purpose of this study is to know the efficacy of the treatment with probiotics,~     Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of~     relapses on antibiotic-associated diarrhea.~   "
218336|NCT00701272|"~     The main objective of this study is to assess whether a recently-developed bioassay for the~     molecule secreted fibrinogen-like protein 2 (sFGL2) can be used to predict the recurrence~     and/or progression of Hepatitis C Virus disease in post liver transplant patients. The~     hypothesis is that patients with chronic HCV have higher than normal levels of sFGL2 in their~     blood both pre- and post-transplantation and that this will inhibit their ability to clear~     HCV, and influence the progression of HCV disease when it recurs.~   "
218337|NCT00701259|"~     Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic~     stomach contents move upward into the esophagus from the stomach. This study will investigate~     the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing~     frequent nighttime heartburn.~   "
218338|NCT00701246|"~     Iron deficiency anemia is the most common nutritional problem in the world.~      The objectives of this study are:~        -  to evaluate the prevalence of anemia in children from 6 to 24 months of age and the~          therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin~          levels.~        -  to compare the effect of folic acid supplementation with ferrous sulfate on the linear~          and weight growth of anemic and non-anemic~      Study hypothesis:~        -  The ferrous sulfate plus folic acid can improve the response on hemoglobin levels.~        -  The folic acid supplementation with ferrous sulfate have effect on the linear and weight~          growth of anemic and non-anemic.~   "
218339|NCT00701233|"~     To compare local steroid injections to local Botulinum toxin A injection in a double-blinded~     study.~   "
218340|NCT00701220|"~     The purpose of this study is to see if taking a cholesterol lowering drug (LIPITOR®) will~     increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart~     failure patients taking this cholesterol-lowering drug, and if this will also show an~     improvement in the damaged areas of the patient's hearts as documented by MRI scans.~   "
218341|NCT00701207|"~     The purpose of this study is to compare peoples with disease (sarcoidosis) to those without~     disease. We want to see if people with sarcoidosis have a different immune response to those~     people without disease.~      The goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for~     sarcoidosis.~   "
218342|NCT00701194|"~     The Early Intervention Foster Care [EIFC] project is an efficacy trial of the Oregon Social~     Learning Center Multidimensional Treatment Foster Care Program, a preventive intervention~     that targets 3 commonly co-occurring variables among young foster children: (1) behavioral~     problems, (2) physiological dysregulation within the neuroendocrine system (i.e., HPA axis~     activity), and (3) developmental delays.~   "
218343|NCT00701181|"~     To evaluate the effectiveness of study drug in improving visual acuity compared to laser~     treatment in the patients with diabetic macular edema~   "
218344|NCT00701168|"~     The purpose of this protocol is to provide supervised and limited access to Therasphere®~     treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis~     who cannot be treated by surgical removal of the affected part of the liver. Patient response~     to treatment and any side effects of Therasphere® treatment will be examined.~   "
218345|NCT00701155|"~     This study is conducted in Africa. The aim of this observational study is to evaluate the~     incidence of serious adverse drug reactions while using insulin Levemir® under normal~     clinical practice conditions in Egypt.~   "
218346|NCT00701142|"~     The primary purpose is to show that administration of Haemocomplettan® P significantly~     reduces the amount of blood products needed during aortic surgery.~   "
218347|NCT00701129|"~     The purpose of this study was to evaluate the efficacy, clinical benefits and safety of a~     prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa~     (Myozyme®) in patients with infantile-onset Pompe disease.~      The objectives were to assess the efficacy of a prophylactic immunomodulatory regimen given~     prior to first treatment with alglucosidase alfa, as assessed by anti-recombinant human acid~     alpha-glucosidase (anti-rhGAA) antibody titers, and antibodies that inhibit the activity~     and/or uptake of alglucosidase alfa; to evaluate the clinical benefit as measured by overall~     survival, ventilator-free survival, left ventricular mass index (LVMI), gross motor function~     and development, disability index and the incidence of adverse events (AEs), serious adverse~     events (SAEs), and clinical laboratory abnormalities.~   "
218348|NCT00701103|"~     This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly,~     every other week. or a every three week infusion.~      The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour~     weekly, every other week, or every three week infusion in participants with advanced cancer~     will be generally safe and tolerated at a dose which achieves a trough concentration ≥3~     μg/mL.~   "
218349|NCT00701090|"~     A study to see if better control of type 2 diabetes can occur in patients taking a stable~     dose of metformin when they are also provided either sitagliptin or glimepiride. This study~     will also see if this treatment is safe and tolerable.~   "
218350|NCT00701077|"~     The Brugada syndrome is a rare disease potentially leading to severe arrhythmic events in~     otherwise healthy subjects.In many patients an Implantable cardiovertor defibrillator (ICD)~     is implanted to prevent sudden cardiac death. ICD are however associated with potential~     complications and are not available in all countries.Pharmacological blockade of specific ion~     channels (Ito) represents a promising therapeutic approach in this syndrome.The~     3,4-diaminopyridine (3,4-DAP) is a pharmacological Ito blocker that can be used in humans.The~     aim of the study is to evaluate the effect of 3,4-DAP on ventricular arrhythmia inducibility~     in Brugada patients requiring an electrophysiological study for arrhythmic risk~     stratification.~   "
218351|NCT00701064|"~     The investigators are testing novel treatments for combat PTSD: bright light exposure and~     negation ion exposure.~   "
218391|NCT00700544|"~     A multicenter randomized trial evaluating the possible benefit of androgens during post~     remission therapy in an attempt to improve the outcome of AML in older patients.All patients~     received the ICL regimen as induction and were randomized to receive, after achieving CR or~     PR, a maintenance therapy including or not androgens. Patients randomized with androgens~     additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to~     2 years~   "
218749|NCT00695773|"~     This study is aimed at discovering the differences in outcomes, regarding quality of life~     issues(continence, impotence) of patients who have had either laparoscopic or open surgical~     technique for prostate cancer.~   "
218352|NCT00701051|"~     Diabetes and its associated complications affect more than 20 million Americans, and the~     prevalence of type 2 diabetes and impaired glucose tolerance rises dramatically with age such~     that 40% of Americans over age 60 are affected. In older adults, glucose metabolism may be~     affected by reduced skeletal muscle capillary supply, which limits insulin, glucose, and~     oxygen delivery to skeletal muscle. Reduced capillary supply to skeletal muscle is found in~     older individuals with impaired glucose tolerance and we hypothesize that this is due to~     reduced vascular growth factor expression, and chronic inflammation. Further, we hypothesize~     that reversal of a sedentary lifestyle through aerobic exercise training will increase~     insulin signaling and vascular growth factor expression, as well as decrease inflammation, to~     increase capillary supply to skeletal muscle, which contributes to improved glucose~     metabolism in older adults. This study will: 1) Determine the mechanisms underlying reduced~     skeletal muscle capillarization in older adults with impaired glucose tolerance; and 2)~     Determine the effect of aerobic exercise training-induced increases in skeletal muscle~     capillarization on glucose metabolism in older adults.~   "
218353|NCT00701038|"~     Congestive heart failure affects 2.3 percent of the population (approximately 4,900,000) with~     an incidence of 10 per 1,000 of the population after the age of 65 (1). The admission rate~     for patients with heart failure is on the rise, so is the mortality associated with it and~     its national annual bill, now exceeding $21 billion (1). Obstructive Sleep Apnea (OSA) is~     present in 11-37 percent of patients with heart failure (2,3), and tends to increase in~     severity when the heart failure is less controlled (4, 5). Therefore, the actual prevalence~     of OSA in patients hospitalized with acute heart failure is likely higher. There is now~     evidence that treatment of OSA with nasal Continuous Positive Pressure (nCPAP) in outpatients~     with stable heart failure improves left ventricular ejection fraction, and quality of life~     (6), and confers a reduction in fatal and non-fatal cardiovascular events (7). However, there~     has not been any evaluation of the role of diagnosis and treatment of OSA in patients~     hospitalized with acute heart failure. This uncertainty about the true prevalence and role of~     OSA in exacerbations of heart failure, and the role of its treatment in the acute setting may~     explain why aggressive diagnostic and therapeutic strategy for OSA in patients admitted to~     the hospital with acute heart failure is not part of the standard clinical practice in acute~     care centers. Given the rising admission rate, and mortality associated with heart failure,~     an evaluation of the role of OSA and its treatment in this patient population is highly~     significant.~   "
218354|NCT00701025|"~     The term exercise-induced bronchospasm (EIB) describes acute, transient airway narrowing that~     occurs during, and most often after, exercise. Manifestations of EIB can range from mild~     impairment of performance to severe bronchospasm and respiratory failure.~      The pathogenesis of EIB remains controversial and the role of airway inflammation has not yet~     been definitively characterized. We plan on comparing markers of inflammation in asthmatic~     participants with and without EIB at baseline and after bronchoprovocation with eucapnic~     voluntary hyperventilation testing (EVH). We also will collect demographic information as~     well as information about asthma control and exercise habits.~   "
218355|NCT00701012|"~     The purpose of this study is to evaluate the defecatory function when nerve fibers around the~     inferior mesenteric artery(IMA) and left colic artery(LCA) are preserved(so called low~     ligation ) or not(high ligation) in the rectosigmoid and rectal cancer surgery.~   "
218356|NCT00700999|"~     The purpose of this study is to examine if treatment of post-traumatic stress disorder in~     combat veterans with paroxetine changes brain responses as measured by functional magnetic~     resonance imaging and if brain responses can predict who will get better with treatment.~   "
218357|NCT00700986|"~     The purpose of the study is to determine whether treatment with a single 800mg dose of~     AZD9056, a medication which has been developed as a possible treatment for Rheumatoid~     Arthritis, has an effect on the function of the retina~   "
218358|NCT00700973|"~     This project is intended to help substance use disorder patients who perpetrate interpersonal~     violence against other adults.~   "
218359|NCT00700960|"~     This study is conducted in Europe. The aim of this observational study is to describe the~     conditions for the concomitant administration of a slow-acting insulin analogue with oral~     antidiabetics (OADs) in order to improve blood glucose control in type 2 diabetes.~   "
218360|NCT00700947|"~     The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with~     chronic primary mitral regurgitation.~   "
218361|NCT00700934|"~     The aim of this study is to describe the natural history of patients with alpha-1 antitrypsin~     associated emphysema and to figure out associated prognostic factors.~   "
218362|NCT00700921|"~     This study will test whether lovastatin helps to modify lung inflammation in patients with~     COPD (Chronic Obstructive Pulmonary Disease).~   "
218363|NCT00700908|"~     Aim 1. Determine the impact of a daily, automated telephone intervention on HbA1c levels~     compared to standard care in older patients with type 2 diabetes.~      Aim 2. Determine the impact of the automated telephone intervention compared to standard care~     on adherence to prescribed SMBG frequency in older patients with type 2 diabetes.~      Aim 3. Determine the impact of the automated telephone intervention compared to standard care~     on self-reported diabetic control problems in older patients with type 2 diabetes.~      Aim 4. Determine the impact of the automated telephone intervention compared to standard care~     on self-reported attitudes and health beliefs concerning diabetes in older patients with type~     2 diabetes~   "
218364|NCT00700895|"~     Interethnic differences in warfarin dose requirements in the Asian population have been well~     described. Our previous studies showed that warfarin maintenance doses in our multi-ethnic~     population were closely related to patient demographics and genetic polymorphisms in~     cytochrome(CYP)P4502C9 and vitamin K epoxide reductase complex subunit 1(VKORC1). A~     retrospective regression model combining these predictors accounts for 57.8% of the~     variability in warfarin dose.~   "
218365|NCT00700882|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with~     locally advanced or metastatic mucosal melanoma or acral melanoma.~   "
218366|NCT00700869|"~     The purpose of this study is to determine if a weaning strategy from artificial ventilation~     governs by respiratory behaviour status assessed by our method is safe enough.~   "
218367|NCT00700856|"~     Background: In patients with type 2 diabetes inadequately controlled with metformin, two main~     therapeutic options are equally plausible: add-on a sulfonylurea (SU) or a thiazolidinedione~     (TZD). Since the two classes of drugs clearly differ in terms of mechanisms of action, side~     effects, economic costs and cardiovascular risk factors profile, a direct comparison of the~     two therapeutic strategies would be most appropriate.~      Aims: 1) To evaluate the effects of add-on pioglitazone as compared with add-on a SU on the~     incidence of cardiovascular events in type 2 diabetic patients inadequately controlled with~     metformin; 2) To compare the two treatments in terms of glycemic control, safety, and~     economic costs.~      Methods: multicentre, randomised, open label, parallel group trial of 48 months duration.~     Eligible participants (type 2 diabetic males and females, aged 50-75 years, BMI 20-45 Kg/m2,~     in treatment for the last two months with metformin 2 gr/die in monotherapy and with HbA1c >~     =7.0% and <= 9.0%) will be randomized to add-on: a SU - glibenclamide (5-15 mg/die),~     gliclazide (30-120 mg/die), glimepiride (2-6 mg/die), chosen according to local practice - or~     pioglitazone (15-45 mg/die). A HbA1c value > 8.0 % on two consecutive occasions will lead to~     addition of insulin to ongoing oral therapy.~      Primary efficacy outcome: a composite endpoint of all-cause mortality, non fatal MI~     (including silent MI), non fatal stroke, and unplanned coronary revascularization.~      Secondary outcomes. Principal secondary outcome: a composite ischemic endpoint of sudden~     death, fatal and non fatal acute MI (including silent MI), fatal and non fatal stroke, major~     amputations (above ankle), endovascular or surgical intervention on the coronary, leg or~     carotid arteries.~      Other secondary outcomes~      - a composite cardiovascular end point including the primary end point plus hospitalization~     for heart failure, endovascular or surgical intervention on the coronary, leg or carotid~     arteries, silent MI, angina - by WHO criteria and confirmed by a new electrocardiogram~     abnormality - intermittent claudication with an ankle/brachial index lower than 090; events~     of heart failure; a microvascular endpoint including: plasma creatinine increase of 2 times~     above the baseline value or creatinine clearance reduction of 20ml/min/1. 73m2 or development~     of overt nephropathy (dialysis or plasma creatinine >3,3 mg/dl) or macroalbuminuria; glycemic~     control (changes from baseline in HBA1c, time to failure of glycemic control, i.e., HBA1c~     >8.0% on two consecutive occasions three months apart); major CV risk factors (lipids, blood~     pressure, microalbuminuria, inflammation markers, waist circumference); safety and side~     effects; direct and indirect costs.~      Data regarding CV endpoints, safety, tolerability, and study conduct will be monitored and~     analyzed by an independent committee, and will be not available to the study investigators~     until the closing of data collection. Efficacy end points will be analyzed on an~     intention-to-treat basis.~   "
218370|NCT00700817|"~     This trial is conducted in Europe and North America. The aim of this trial is to compare the~     effect on blood sugar control of liraglutide or sitagliptin, both in combination with~     metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.~      The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:~        1. Week 27-52 after randomisation~           - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and~          dosing regimen.~        2. Week 53-78 after randomisation~             -  Subjects receiving sitagliptin at the end of week 52 after randomisation will~               discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or~               liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and~               increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.~             -  Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after~               randomisation will continue the treatment at unchanged dose and dosing regimen.~               Trial completion is planned for June 2010.~   "
218371|NCT00700804|"~     The primary objective is to determine whether meat interacts positively with calcium to~     improve calcium retention. The secondary objective is to determine whether any interaction~     between dietary protein and calcium affects biomarkers of bone metabolism.~   "
218372|NCT00700791|"~     The overall goal of this study is to determine the efficacy of tocotrienol (TCT), a natural~     form of vitamin E, in preventing or reducing scar formation in human skin wounds as well as~     the basal levels of TCT in normal human skin and adipose tissue.~   "
218373|NCT00700778|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women~     with BRCA1 mutations.~      PURPOSE: This clinical trial is studying recombinant human chorionic gonadotropin in~     preventing breast cancer in premenopausal women with BRCA1 mutations.~   "
218374|NCT00700765|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     incidence of adverse events while using Levemir® under normal clinical practice conditions.~   "
218375|NCT00700752|"~     This study seeks to evaluate the clinical and subjective performance of two established soft~     contact lenses.~   "
218376|NCT00700739|"~     The purpose of the study is to evaluate the performance of the Discover cervical Artificial~     disc in the treatment of degenerative disc disease in one level of the cervical spine.~   "
218377|NCT00700726|"~     The purpose of this study is to determine if a simple blood test can help in disease~     management, particularly asthma. This will be researched by looking at certain features of~     the blood and to compare asthmatics without allergies to those that have allergy-induced~     asthma.~   "
218378|NCT00700713|"~     Study will evaluate the persistence of antibodies approximately three years after an initial~     dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and~     age-matched Menactra naive participants.~      Objectives:~        -  To assess the persistence of antibody responses three years after one or two doses of~          Menactra® vaccine in subjects who participated in study MTA26.~        -  To describe the antibody responses to a single dose of Menactra® vaccine in subjects who~          had previously received one or two doses of Menactra® vaccine and in Menactra®~          vaccine-naïve subjects.~        -  To describe the safety profile of a single dose of Menactra® vaccine in subjects.~   "
218379|NCT00700700|"~     A new therapy for patients with advanced heart failure (HF) involves the implantation of a~     specialized pacemaker device (Cardiac Resynchronization Therapy, CRT) that attempts to~     restore the synchronized contraction of the ventricular chambers of the heart. In some~     people, CRT improves exertional breathlessness and allows them to exercise for longer~     periods. However, to date, the mechanisms by which CRT improves symptoms and exercise~     tolerance is unknown. This study will use in-depth cardiopulmonary exercise testing and~     pulmonary function testing to explore these mechanisms in greater detail.~   "
218380|NCT00700687|"~     We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different~     treatments~   "
218381|NCT00700674|"~     To determine if the usage of EEG Entropy helps to reduces the incidence of POCD in elderly~     patients after general anesthesia.~   "
218382|NCT00700661|"~     A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to~     5 Years.~   "
218383|NCT00700648|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the side~     effects profile and benefits of using intravenous insulin aspart infusion in hospitalised~     subjects under normal clinical practice conditions in India.~   "
218384|NCT00700635|"~     To explore the potential benefit of the administration of Menactra vaccine as a two-dose~     regimen to children.~      Primary Objective:~      To assess, by age group, the immune response to Menactra vaccine after each vaccine~     injection.~   "
218385|NCT00700622|"~     The objective of this study is to demonstrate that TI® Inhalation Powder combined with~     Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.~   "
218386|NCT00700609|"~     The purpose of this project is to assess the effectiveness of a family-based therapy~     (Attachment based family therapy-ABFT) for Norwegian adolescents (13-17 years) referred to~     specialist mental heath clinics.~   "
218387|NCT00700596|"~     This study evaluates the effects of Salvinorin A (SA). SA is the active ingredient of the~     plant Salvia divinorum that is known to have been used by Mexican Indians as part of~     religious rituals. The purpose of this project is to understand what people experience when~     they consume Salvinorin A.~   "
218388|NCT00700583|"~     The aim of the present study was to determine whether the combined administration of a~     diuretic agent, hydrochlorothiazide, at night would improve the frequency of nocturia~     unresponsive to alpha-blocker monotherapy in men with LUTS.~   "
218389|NCT00700570|"~     This single arm study will assess the resection rate of liver metastasis, time to disease~     progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin~     and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable~     liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle,~     oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5~     and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and~     the target sample size is <100 individuals.~   "
218392|NCT00700531|"~     Hypothesis: Free light chain removal haemodialysis will increase the rate of renal recovery~     in patients with cast nephropathy, severe renal failure and de novo multiple myeloma.~      This study will randomise patients with multiple myeloma and severe renal failure to~     treatment to remove free light chains by haemodialysis or not.~   "
218393|NCT00700518|"~     The purpose of this study is to evaluate the blood flow response to topical Glyceryl~     Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.~   "
218394|NCT00700505|"~     To determine the safety and efficacy of the ThermaRx heating device for the application of~     controlled low level heat to improve symptoms of LUT dysfunction (hesitancy, urgency).~   "
218395|NCT00700492|"~     A randomized study to investigate if hormonal luteal support after intra-uterine insemination~     (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the~     pregnancy rate~   "
218396|NCT00700479|"~     A randomized crossover trial to determine the effects of sodium loading and aldosterone~     infusion on endothelial function in normal subjects.~   "
218397|NCT00700466|"~     Chronic beta-adrenoceptor blockade is known to improve outcome of high risk patients whereas~     amelioration of autonomic activity was demonstrated to be a major cause of outcome~     improvement. Therefore, perioperative beta-adrenoceptor blockade is recommended in patients~     with Revised Cardiac Risk Index score of three or greater. The investigators hypothesise that~     preoperative intravenous beta-adrenoceptor blockade for treatment of hypertension and/or~     tachycardia improves autonomic activity reflected by increase of Total Power of Heart Rate~     Variability.~      Material and Methods: After IRB approval 20 patients scheduled for elective cardiac surgery~     were included into the study. Routine medication was continued throughout the study as~     recommended by the guidelines. HRV (TP and Low to High Frequency ratio (LF/HF) reflecting~     sympathetic to parasympathetic balance) was analysed prior to induction of general anesthesia~     and beta-adrenoceptor blockade in all patients (Baseline). Patients were assigned by their~     baseline hemodynamics. Patients with hypertension (systolic blood pressure > 140mmHg or~     diastolic blood pressure > 90mmHg) or tachycardia (heart rate > 80bpm) were assigned to group~     BETA-BLOCK. In this group metoprolol-boli (2mg) were administered intravenously in stepwise~     manner until hemodynamic values decreased to normal. Total dosage was recorded. After~     normalisation of hemodynamics, second HRV analysis was performed (Intervention). Normotensive~     and normocardic patients were assigned to group CONTROL. No intervention was performed.~     Statistics: Mann Whitney U test for comparison between groups and between events Baseline and~     Intervention within group BETA-BLOCK, p<0.05.~   "
218398|NCT00700453|"~     1. Young adults who are exposed to 7-10 days of play of violent video games will show~          reduced activation in certain regions of the dorsolateral prefrontal cortex and anterior~          cingulate cortex.~        2. Young adults who are exposed to 7-10 days of violent video games will show increased~          activation in regions of the amygdala.~        3. Young adults who abstain from violent video games for a week, after 7-10 days of play of~          violent video games, will show increased activation of regions in the dorsolateral~          prefrontal cortex and anterior cingulate cortex and decreased activation of the~          amygdala, on pre-post fMRI and compared to young adults who continue to play violent~          video games.~        4. Young adults who complete a computerized attention-training program after 7-10 days of~          violent video games will show increased activation of regions in the dorsolateral~          prefrontal cortex and anterior cingulate cortex and decreased activation of the~          amygdala, on pre-post fMRI and compared to young adults who continue to play violent~          video games.~   "
218399|NCT00700440|"~     This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT +~     concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.~   "
218400|NCT00700427|"~     LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with~     Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label~     conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study.~     Those patients that meet the response criteria will continue the blind phase of the study up~     to a year. During that period, patients that respond to atomoxetine will be randomized to~     continue the treatment with atomoxetine or with placebo (neither the patients nor~     investigators know if patients receive atomoxetine or placebo).~   "
218401|NCT00700414|"~     This study aims to collect demographic and medical information including detailed family~     history of cancer of children and adolescents with adrenocortical tumors in order to learn~     more about the clinical and epidemiological aspects, treatment modalities, and outcome of~     patients with this rare disease, worldwide.~      In addition, investigators at St. Jude Children's Research Hospital (SJCRH) plan to perform~     molecular studies of tumor cells aimed to clarify the role of the TP53 gene and other genetic~     pathways in these tumors. They aim to obtain relevant biological material from participants~     with adrenocortical tumor (ACT), their biological parents, and relatives for determination of~     the TP53 germline status, molecular studies of the TP53 gene, and other molecular pathways.~   "
218402|NCT00700401|"~     This single arm study will investigate the predictive value of a week 4 virological response~     on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3,~     treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180~     micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4~     will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up.~     Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive~     PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months,~     and the target sample size is 100 individuals.~   "
218403|NCT00700388|"~     Mechanical devices to increase the individual's bronchial hygiene are commonly used in~     patients with chronic retention of secretions and abnormal cough reflex. In this clinical~     context a new technology (namely TPEP® - Temporary Positive Expiratory Pressure) has been~     recently developed with the aim to improve the respiratory condition in patients suffering~     from chronic respiratory diseases. This trial has the aim to assess the clinical efficacy of~     TPEP in patients with chronic hypersecretion and airways obstruction, but with a normal~     competence of the cough reflex~   "
218404|NCT00700375|"~     This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients~     undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.~   "
218405|NCT00700362|"~     Normoglycemia is important for the outcome of surgical and medical conditions. Insulin~     infusions have been studied to achieve normoglycemia during these circumstances and have~     proved to be useful. Insulin given by subcutaneous injections has longer duration compared to~     intravenous given insulin which makes it more difficult to control. The hypothesis behind the~     trial is the concept that insulin infusion is more effective in reaching normoglycemia in~     diabetic subjects during foot ulcer infection and surgical wound infection.~        -  The study evaluates a target controlled insulin infusion or conventional therapy as~          antidiabetic treatment during foot ulcer infection and surgical wound infection.~        -  Secondary efficacy parameter will be hospital stay, laboratories for inflammation and~          oxidative stress.~   "
218406|NCT00700349|"~     This study involves randomization of individuals who were initially rejected from a~     micro-lending organization in South Africa. Subjects were placed into two arms: (1) not~     receiving a loan; (2) being reconsidered for a second look. Of those in the second arm, 53%~     were then selected by the organization's loan officers to receive a standard loan for~     first-time borrowers. Mental health and financial data were collected at one timepoint:~     approximately 6-12 months after the subjects first applied for the loan.~   "
218407|NCT00700336|"~     The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined~     with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid~     malignancy that is metastatic or unresectable and for which standard curative or palliative~     measures do not exist or are no longer effective or would otherwise be eligible for cisplatin~     and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined~     based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet~     combination will be assessed during the phase I part of the trial.~      The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at~     the MTD determined in the phase I part) in previously untreated, unresectable malignant~     pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed,~     cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be~     stratified according to histology and performance status.~   "
218408|NCT00700323|"~     To assess the effect of phosphatidylserine-omega-3 consumption on the immune system~     parameters in children suffering from attention and concentration deficits.~   "
218409|NCT00700310|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel~     when given as an adjunctive therapy in subjects with refractory partial seizures.~   "
218410|NCT00700297|"~     Colchicine was first used in Behcet's Disease (BD), in 1977. There are controversial reports~     of the efficacy of Colchicine in BD. For some experts the unresponsiveness of some patients~     could be explained by genetic difference between the Silk Road BD and sporadic BD from other~     parts of the world.~      To test this hypothesis (the inefficacy of colchicine in the Silk Road BD), we designed a~     randomized double-blind controlled crossover study in Iran, which is in the middle of the~     Silk Road, and has the second highest prevalence of BD in the world.~   "
218411|NCT00700284|"~     The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring~     to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent~     7-day exposure to a placebo ring containing no investigational agent. They then underwent~     7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed~     in terms of safety and tolerability as well as drug delivery.~   "
218412|NCT00700271|"~     This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label,~     blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients~     with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5~     mg alone.~   "
218413|NCT00700258|"~     The purpose of this registry is to obtain a general view as regards efficacy, tolerability~     and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with~     advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and~     gastro-intestinal stroma tumors (GIST) under the conditions of routine use~   "
218414|NCT00700245|"~     The human adipose and muscle -tissue produce and release a number of bioactive proteins which~     contributes to the chronic low grade of inflammatory status which is associated with obesity~     and plays an important role in the pathogenesis of type 2 diabetes and cardiovascular~     diseases.~      Study 1: Our aim is to investigate if exercise has independent and additive effects in~     combination with diet-induced weight loss on circulating levels of inflammatory markers and~     mRNA levels in subcutaneous adipose tissue (SAT) and skeletal muscle tissue (SM.~      Study 2: Our aim is to investigate whether gender and weight status plays a role in the~     metabolic response during two hours of acute exercise~   "
218415|NCT00700232|"~     Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a~     subtype of progressive familial intrahepatic cholestasis, have been reported in women~     suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of~     these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy~     have not been clearly established.~      The aim of the present study is to describe the nature and frequency of these mutations in a~     series of patients with intrahepatic cholestasis of pregnancy and to compare with a control~     group of pregnant women without intrahepatic cholestasis of pregnancy.~   "
218416|NCT00700219|"~     The purpose of this study is to collect clinical specimens and corresponding clinical data to~     develop a non-invasive test for detection of intra-amniotic infection and prediction of~     preterm birth in women and intact amniotic membranes. The specimens collected will be used to~     develop a specific biomarker panel and algorithm using immunoassays for optimal detection of~     intra-amniotic infection in women with preterm labor and intact amniotic membranes.~   "
218417|NCT00700206|"~     This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of~     Telintra in patients with Low or Intermediate-1 risk MDS. Patients at least 18 years of age~     presenting with histologically confirmed Low to Intermediate-1 risk MDS with documented~     significant cytopenia for at least two months by the IWG criteria are eligible.~   "
218418|NCT00700193|"~     The purpose of this study is to determine the Safety, Tolerability & Immunogenicity of CSL~     Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month~     booster vaccination, in a paediatric population equal to or greater than 6 months to less~     than 9 years old.~   "
218419|NCT00700180|"~     This study will explore the correlation of biomarkers with response rate, and the overall~     efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in~     patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be~     randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week~     cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive~     treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles.~     The anticipated time on study treatment is until disease progression, and the target sample~     size is 100-500 individuals.~   "
218420|NCT00700167|"~     Cancer cells make proteins called antigens that act as markers for the tumor cells. These~     antigens cannot cause the cancer itself. Special white blood cells, called T cells or T~     lymphocytes, recognize and respond to antigens. In many diseases, these and other cells in~     the immune system help your body get rid of the disease. However, T cells are normally~     resting, and they need other proteins on the diseased cell surface to begin working.~     Unfortunately, cancer cells do not usually make all the other proteins that T cells need to~     work. Therefore, T cells do not normally work against the cancer cells. We think this is one~     of the reasons that cancers grow and are not rejected by the body in the first place.~      Another white blood cell, called a dendritic cell, does have most if not all of the special~     proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not~     normally have the cancer proteins on their surface. The challenge then is to combine the~     cancer markers (antigens) with these dendritic cells to make a vaccine. We think that the~     body's T cells might then react against the tumor and help destroy it. This study will see if~     putting tumor antigens made in a lab onto dendritic cells will make T cells work against~     tumor cells. We want to answer this question by injecting you with dendritic cells loaded~     with the antigens. Then we will check for a response based on lab studies and your own~     clinical course. We will compare your response against melanoma with your response against a~     common antigen, to which almost everyone has already been exposed. Flu, for example, is a~     common antigen to which most people have been exposed. We also need to test your response to~     an antigen that your body has not likely seen before. For example, we plan to use KLH~     (keyhole limpet hemocyanin), which is a pigment or color protein made from a sea creature~     known as a keyhole limpet. Each of these, the flu and KLH antigens, which should be harmless~     to you, will be used along with the dendritic cell-tumor vaccine. This will help us find out~     if the vaccine is working, based on the lab studies we will check before and after the~     vaccinations.~   "
218421|NCT00700154|"~     Normoglycemia is important for the outcome of surgical and medical conditions. Insulin~     infusions have been studied to achieve normoglycemia during these circumstances and have~     proved to be useful. Insulin given by subcutaneous injections has longer duration compared to~     intravenous given insulin which makes it more difficult to control. The hypothesis behind the~     trial is the concept that insulin infusion is more effective in reaching normoglycemia in~     diabetic subjects during treatment for ulcer infections and/or planned cardio-vascular~     surgery.~        -  The study evaluates a target controlled insulin infusion or conventional therapy as~          antidiabetic treatment during ulcer infection and after cardio- vascular surgery.~        -  Secondary efficacy parameter will be hospital stay, laboratories for inflammation and~          oxidative stress.~   "
218422|NCT00700141|"~     Considering the total number of thyroid procedures in Germany (100000 - 120000 cases per~     year), TachoSil® is a valuable tool to support surgical haemostasis, avoiding lymph leaks and~     support speech-nerve saving approaches. The aim of this study was to evaluate a patient and~     procedure profile where TachoSil® is most beneficial.~   "
218423|NCT00700128|"~     This study will examine the combined effects of a continuous oral contraceptive (OC) regimen~     with supplemental frovatriptan therapy on headache severity and occurrence in subjects with~     documented Menstrually Associated Migraines (MAM). The subjects enrolling in the study will~     have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal~     contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen~     following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs,~     the subject will institute a 4-day hormone-free interval (HFI). In an attempt to~     prevent/lessen the severity of headache during the HFI, subjects will be randomized to~     prophylactic administration of a triptan or placebo during this period. If no BTB/BTS occurs~     after 80 days of continuous pills, the subject will institute a 4-day HFI during which they~     will be randomized into triptan or placebo groups.~      The purpose of this research study is to examine the effects of continuous oral contraceptive~     pills and frovatriptan on headaches that occur around the time of your period. Many woman~     take continuous oral contraceptive pills (OC) and when OCs are stopped they may get~     headaches. This study will look if taking frovatriptan around the time of the period will~     affect the headache, and how it will be affected. Frovatriptan is an FDA approved drug for~     migraine headaches.~      This study is a prospective pilot trial.The study will last approximately 35-39 weeks.~   "
218424|NCT00700115|"~     This study will examine the effectiveness and safety of raltegravir (isentress) when used~     together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is~     a recently, Food and Drug Administration (FDA) approved, HIV medication that has strong~     effects against the HIV virus. Isentress has been shown in other studies to be safe and well~     tolerated by HIV patients. Combining this drug with kaletra might enable us to construct a~     HIV regimen that does not include the more toxic drugs of the nucleoside reverse~     transcriptase inhibitor class.~      Eligible volunteers will undergo the following as part of the study procedure:~        1. Sign the study consent form and the HIPAA Authorization Form.~        2. Two-third of subjects, the intervention group (selected by random chance) will have~          their HIV drug treatment changed to kaletra + isentress.~        3. The other one-third will continue their usual HIV medications (this will be the control~          group).~        4. Make 9 study related visits to the Ponce clinic during the 48 weeks study period. During~          these visits, medical information will be collected, and blood tests will be performed.~        5. Perform Dexa-scan on two separate occasions at Emory University Hospital Radiology.~      Information collected will be used to assess the effectiveness of this treatment in keeping~     the HIV virus suppressed, how well these two drugs together is tolerated by HIV-infected~     patients, and the blood levels of these two drugs when given together.~   "
218425|NCT00700102|"~     This study will evaluate the efficacy and safety of adding bevacizumab to crossover~     fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have~     experienced disease progression under first line treatment with standard chemotherapy plus~     bevacizumab. Participants will receive chemotherapy alone, or in combination with~     bevacizumab. The anticipated time on study treatment is until disease progression or~     unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after~     stopping chemotherapy.~   "
218487|NCT00699283|"~     Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited~     number of AEDs are approved for use as monotherapy. The objective of this study is to~     evaluate the efficacy of BRV in the conversion of partial onset seizure patients from~     combination treatment to monotherapy.~   "
218488|NCT00699270|"~     The purpose of this prospective clinical data collection is to document the performance and~     clinical outcomes of Biomet Humeral Stems~   "
218426|NCT00700089|"~     Background~      Previous suicide attempts is a high-risk factor with a repetition rate between 12-30 percent.~     Compliance with after treatment is often poor. A systematic review by Hawton, 1999 states a~     lack of evidence on psychosocial interventions due to selections bias or statistical power.~      Objective~      The aim is to investigate if assertive outreach, incorporating hands-on guidance and~     motivational support of compliance with follow-up treatment after suicide attempts is able to~     reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.~      Method and Design~      A randomized, controlled intervention trial in a prospective design. The patients included~     will be randomized to either standard treatment (n = 120) or intervention treatment (N =~     120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide~     attempts or deliberate self-harm. The outreach contacts are thought of as supporting and~     guiding home visits towards compliance with after care or follow-up treatment Inclusion~     criteria Males and females, aged 12 years or older with a recent suicide attempt or act of~     deliberate self-harm, living independently and not diagnosed with severe mental illness~     (psychosis, severe dementia)~      Outcome~      The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by~     the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate~     self-harm registered in the medical records by the collaborating wards and units in their~     routine procedure of treating people applying for help in relation to suicidal behavior.~   "
218427|NCT00700076|"~     Org 25935 is a new putative antipsychotic agent developed by N.V. Organon.The primary~     objective of this study is to investigate the effect of Org 25935 on ketamine-induced~     impairments in immediate recall.~   "
218428|NCT00700063|"~     This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and~     0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the~     face or scalp.~   "
218429|NCT00700050|"~     The general objective is to elucidate the mechanisms whereby sex hormones may modulate the~     severity of respiratory disease. An important component of this proposal is a systematic and~     intensive approach to characterize how the cellular and cytokine components of airway~     inflammation respond to fluctuations in sex hormone levels.~      The effects of menstrual fluctuations in levels of sex hormones on inflammation and bacterial~     load in respiratory secretions of CF patients will also be determined.~   "
218430|NCT00700037|"~     To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of~     coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary~     syndrome.~   "
218431|NCT00700024|"~     The purpose of this study is to determine the effect of training and testim on Hypogonadism.~   "
218432|NCT00700011|"~     The investigators hypothesize that, in addition to its apoptotic effect, clofarabine induces~     DNA hypomethylation. If the investigators' hypothesis is correct, findings from the present~     proposal will not only contribute to information relating to the mechanisms of action of~     clofarabine but also provide the opportunity for combined epigenetic targeting of MDS using~     clofarabine with either another hypomethylating agent or a histone deacetylase inhibitor.~      Clofarabine has demonstrated anti-cancer activity through inhibition of DNA synthesis and~     repair, induction of apoptosis, and possibly through other mechanisms. Numerous responses~     have been observed after treatment with clofarabine in heavily pre-treated~     relapsed/refractory patients with ALL, AML and high risk MDS.~      In the present proposal, the investigators will study the clinical and laboratory effects of~     2 different dosages of clofarabine in patients who have failed the hypomethylating agent,~     5-azacytidine. This study will recruit patients who have received at least six cycles of~     5-azacytidine without response or whose disease has progressed or relapsed while on~     5-azacytidine. The first cohort of patients will receive clofarabine 10 mg/m2/day for five~     days and the second cohort of patients 5 mg/m2/day for five days, both every four to six~     weeks. The investigators will determine the frequency of response to the two dosages of~     nucleoside analog in this group of patients. Measurement of responses will include~     improvement in the peripheral blood count, reduction in the blood and platelet transfusion~     need and eradication of cytogenetically abnormal clones. Successful completion of this study~     will define the position of clofarabine in MDS in the era of epigenetic targeting.~   "
218433|NCT00699998|"~     This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a~     medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute~     coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary~     revascularization).~   "
218434|NCT00699985|"~     To find the overall psychological profile of patients with Behcet's Disease (BD) and compare~     it with Non-BD patients.patients were checked for psychological symptoms by Symptom Check~     List 90 Revised (SCL90-R)~   "
218435|NCT00699972|"~     The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel~     when given as an adjunctive therapy in subjects with refractory partial seizures.~   "
218436|NCT00699959|"~     The purpose of this observational study is to compare frequency of attainment control goals~     through the more represented cardiovascular factor risk, dyslipidemia, among coronary~     patients with or without heart failure in cardiology consulting.~   "
218437|NCT00699946|"~     In this study we wanted to determine if perioperative administration of olanzapine prior to~     knee or hip replacement surgery in high risk patients would prevent the onset of~     postoperative delirium.~   "
218438|NCT00699933|"~     The study aims to evaluate the course of patients with acute pancreatitis. Thereby we analyze~     different diagnostics and compare ultrasound, MRI and CT-scan in detection of necrotic areas~     and evaluate interventional therapy methods like percutaneous drainage techniques regarding~     the outcome. Laboratory values were assessed as well.~   "
218469|NCT00699517|"~     The primary objective of the study is to compare the progression-free survival (PFS) in the 2~     treatment arms~      The secondary objectives of the study are :~        -  To compare the overall survival in the 2 treatment arms~        -  To compare the objective response rate in the 2 treatment arms~        -  To assess the safety profile of AVE8062 (in combination with the background cisplatin~          therapy)~        -  To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a~          population approach, in all patients enrolled in selected centers.~   "
218470|NCT00699504|"~     To assess the safety of cangrelor on cardiac repolarization as measured by electrocardiogram~     (ECG) at therapeutic and supratherapeutic doses.~   "
218439|NCT00699920|"~     Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction)~     adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus~     Coartem, based on the first malaria attack of each patient.~      Secondary objectives:~      For the first attack:~      To compare the 2 groups of treatment in terms of:~        -  Day 42 efficacy~        -  Parasitological and fever clearance~        -  Clinical and Biological tolerability~        -  Evolution of gametocyte carriage~      For attack 2nd and following:~      To compare the 2 groups of treatment in terms of:~        -  Day 28 and Day 42 clinical and parasitological effectiveness~        -  Clinical and Biological tolerability~        -  Proportion of patients without fever at Day 3~        -  Proportion of patients without parasites at Day 3~        -  Evolution of gametocyte carriage~        -  Compliance~      During the total follow up of the cohort:~      To compare the 2 groups of treatment in terms of:~        -  Treatment incidence density~        -  Impact of repeated treatment on clinical and biological tolerability~        -  Impact on anaemia~        -  Impact on Hackett score.~   "
218440|NCT00699907|"~     Studying samples of blood and tissue in the laboratory from patients with a high risk of~     developing ovarian cancer may help doctors identify and learn more about biomarkers related~     to cancer. We hypothesized that (i) preclinical biologic evidence exists for the role of~     androgens in ovarian cancer development and (ii) flutamide treatment of women at high risk~     for ovarian cancer may identify meaningful tissue biomarkers of androgen action and of~     ovarian cancer initiation. This phase II trial studied the effect of flutamide on biomarkers~     in blood and tissue samples from patients at high risk of ovarian cancer.~   "
218441|NCT00699894|"~     Postoperative nausea and vomiting (PONV) persists as one of the more common complications of~     surgery. Although rarely life-threatening, it is the postoperative outcome that is most~     unfavorable to patients, even more undesirable than pain. Orthognathic surgery corrects~     conditions of the jaws and face related to structure, growth, sleep apnea, bad bite, or~     congenital malformations. The bones of the face and jaws are cut and placed in a new~     position. There is a high rate of PONV in orthognathic surgery (56%). It is particularly~     challenging to the patient as their jaws are kept closed together with wires or elastic~     bands. Nausea in a patient with restricted mouth opening can be psychologically unnerving and~     puts them at risk for fluid in their lungs.~      Gan and colleagues showed a higher efficacy of aprepitant over ondansetron in preventing PONV~     and nausea severity after open abdominal surgery. From this study, the FDA approved the use~     of aprepitant for PONV prevention in patients >18 years of age. Gan suggested further~     investigation in different populations.~      Our randomized, double-blind, prospective study will compare the efficacy of aprepitant PO~     versus ondansetron IV in a high risk setting for PONV: adolescents undergoing orthognathic~     surgery.~      Our study will involve 200 consecutive, adolescent patients (ages 15-25) who will undergo at~     least a Le Fort 1 osteotomy (upper jaw surgery) under general anesthesia and require hospital~     admission for at least one night. We will exclude patients who are currently taking~     medications that have interactions with aprepitant (pimozide, terfenadine, astemizole,~     cisapride), those who have a known vomiting disorder such as bulimia, and those who have~     vomited for any reason within 24 hours of surgery. The procedure will be performed by 5~     surgeons and general anesthesia will be administered by 3 anesthesiologists at one~     institution. A study coordinator, who will not be involved in the treatment, will create the~     randomization schedule in order to ensure blindness. The patients will be randomized to~     either of two groups: 1) aprepitant 40 mg PO 2) ondansetron 4 mg IV. Appropriate verbal and~     written consent will be obtained by the priniciple investigator or surgeon.~      On the day of the procedure, all patients will receive a pill (aprepitant or aprepitant~     placebo) at least 1 hour prior to induction of anesthesia and an IV infusion (ondansetron or~     saline) over 2-5 minutes prior to intubation. The timing and doses of medications will be~     consistent with manufacturer's recommendations. An established protocol will ensure every~     patient will receive the same anesthetic regiment. Patient's fluid status will be closely~     monitored and hydrated appropriately according to known fluid balance calculations.~      Efficacy will be assessed based on criteria set by Gan et al and will be based on the~     presence/absence of a vomiting episode, use of rescue medication and subjective evaluation of~     nausea. Patients will be monitored continuously in the PACU and on the hospital floor by the~     caring team (nurse, resident, anesthesiologist, surgeon) for any emetic episode or use of~     rescue therapy. An emetic episode is defined as an act of vomiting (oral expulsion of stomach~     contents) or retching (non-productive vomiting). Nausea will be assessed at intervals of 0,~     2, 6, 24 hours after surgery with T0 being time of extubation. Patients will rate nausea on a~     11-point verbal rating scale, with 0 being not nausea to 10 being the worst nausea.~     Rescue medication will be offered if the patient has more than one episode of vomiting or~     retching, if the patient has nausea lasting longer than 15 minutes, or if the patient~     requests it for established nausea or vomiting.~   "
218442|NCT00699881|"~     The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with~     FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy~   "
218443|NCT00699868|"~     This prospective study evaluate the immune status of patients admitted in ICU.CMV remains~     dormant in the body, but in people with immune deficiency, CMV could reactivate and cause~     life-threatening pneumonia.~   "
218444|NCT00699855|"~     Primary objective is to assess the relationship between changes from serum biomarkers~     observed after 1 month of Saizen® therapy and change in height, weight after up to 5 years of~     treatment with Growth Hormone in children with Growth Hormone Deficiency (GHD) and Turner~     Syndrome (TS).~   "
218445|NCT00699842|"~     Revlimid® (Lenalidomide) is indicated for a type of blood cancer, myelodysplastic syndrome~     (MDS), at 10mg for a specific type of myelodysplastic syndrome with a genetic abnormality~     called deletion 5q in Low and Intermediate-1 (INT-1) patients (staging system according to~     International Prognostic Scoring System (IPSS)). The purpose of this Phase I/II study is to~     determine the optimal dose of Revlimid® (Lenalidomide) in MDS Low and MDS INT-1 patients~     without deletion 5q by slowly increasing the dose while monitoring blood counts for safety~     evaluation as well as observe other adverse events. Efficacy will also be observed for the~     phase II portion of the study.~   "
218446|NCT00699829|"~     Mohs' micrographic surgery (MMS) is a treatment of choice for high recurrence risk basal-cell~     carcinomas (BCC). Realized under local anaesthesia, it induces very low recurrence rates and~     spares unnecessary excision of intact surrounding tissues, thus decreasing the needs for~     flaps, skin grafts, and allows immediate reconstruction…. Its disadvantages are mainly: need~     for a significant training of the operator, the pathologist and the non-medical personnel;~     longer duration of the procedure, with higher a priori costs, and constraints for the patient~     related to the duration of the intervention. Traditional surgical excision with immediate or~     differed reconstruction is the technique of reference. Provided that re-excisions are~     performed as long as previous ones do not guarantee free margins, it gives good results. Its~     real costs are poorly known and can be enhanced by several considerations: multiplicity of~     the operational acts if the initial excision is insufficient, more complex reconstruction~     procedures, duration of post-operative dressings, ….~      The investigators' objective is to know the costs of the surgical treatment of the high risk~     CBC, comparing the CMM with the surgical excision with immediate or differed reconstruction,~     along with its effectiveness defined by the absence of recurrence. by its impact on the~     quality of life of the patient. It is a prospective, multicentric, comparative, not~     randomized, open, cohort study, of the type here and elsewhere. Patients with high-risk~     CBC, as defined by the French ANAES Guidelines (2004), will be included:~        -  clinically morpheaform aspect or ill-limited margins, aggressive histological forms;~        -  already recurred BCC (except for superficial BCCs));~        -  nodular BCC located in the high-risk zone (nose, peri-orificial areas of the head) and~          with diameter larger than 1 cm.~      The effectiveness will be measured by the rate of recurrence at 5 years (as measured by the~     prolongation of the follow-up after the surgical procedure). The utility from the patient~     point of view will be evaluated by a specific dermatologic quality of life questionnaire~     (Skindex) and by a generic questionnaire (Euroqol 5D), supplemented by a questionnaire of~     satisfaction of the care (Attkisson). The economic perspectives studied will be those of the~     hospital, of the payer and of the society. Direct medical costs will be evaluated by~     micro-costing. The main production factors implied in the realization of one CMM or one~     traditional surgery in dermatology/surgery and anatomopathology wards will be identified,~     counted, and developed. The measuring units will be the estimate of the time devoted to each~     individual procedure, reported to the total activity of each ward and the wages of the~     various categories of personnel implied, and the unit costs in consumable and redeemable~     material, reported to their utilisation factor. The hospital indirect costs will be estimated~     by the financial services of the hospitals. Accrual of 150 CMM and 300 traditional excisions~     will be performed within a two year period of time.~   "
218447|NCT00699816|"~     To prove that the efficacy and safety of 'Green Cross CELL* Immuncell-LC group' is superior~     to 'non-treatment group(Control group)' in patient undergone curative resection(PEIT, RFA or~     operation) for hepatocellular carcinoma in Korea~   "
218448|NCT00699803|"~     Study of T-PRED(TM) compared to Pred Forte(R)~   "
218449|NCT00699790|"~     The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves~     glucose homeostasis in drug-naive type 2 diabetic patients~   "
218450|NCT00699777|"~     This study is a randomized, open-label, crossover study to assess the bioequivalence of 1~     risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral~     dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.~   "
218451|NCT00699764|"~     The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t)~     with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative~     consorts of subjects with genital herpes disease.~   "
218452|NCT00699751|"~     ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical~     study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone~     refractory prostate cancer and skeletal metastases.~   "
218453|NCT00699738|"~     This study will evaluate the physiological and pathophysiological determinants of pregnancy~     and feeding method on the maternal cardiovascular system. This includes non-invasive~     measurements.~   "
218454|NCT00699725|"~     Prospective multicentric study to evaluate the compliance of gastroprotective treatment in~     NSAID patients at risk of GI complications. Secondary objectives: To identify the factors~     associated to treatment compliance (both NSAID and PPI), to evaluate the relationship between~     compliance and NSAID-associated GI events~   "
218455|NCT00699712|"~     To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac~     output and wedge pressure in patients with stabilized acute heart failure~   "
218456|NCT00699699|"~     This observational non-interventional study is designed to demonstrate the improvement of~     physical function in COPD patients on treatment with Spiriva Respimat and allows adverse~     events to be recorded and evaluated.~   "
218471|NCT00699491|"~     This phase I/II trial is studying the side effects and best dose of cixutumumab when given~     together with temsirolimus and to see how well they work in treating patients with breast~     cancer that has recurred (come back) at or near the same place as the original (primary)~     tumor or has spread to other places in the body. Monoclonal antibodies, such as cixutumumab,~     can block tumor growth in different ways by targeting certain cells. Temsirolimus may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     cixutumumab together with temsirolimus may be a better treatment for breast cancer.~   "
218489|NCT00699257|"~     The purpose of this prospective data collection is to document the performance and clinical~     outcomes of the Oxford® Partial Knee System.~   "
218490|NCT00699244|"~     Does ultrasound increases the success rate and if there is a difference in success rate~     between placing the local anesthetic centrally versus peripherally.~   "
218491|NCT00699231|"~     This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an~     MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in~     haemodialysis patients with or without previous vaccination against hepatitis B~   "
218457|NCT00699686|"~     Endothelial progenitor cell (EPC) level represents a surrogate marker of cardiovascular risk~     and an indicator of the ongoing vascular damage. Moreover, EPCs are involved in the~     pathogenesis of virtually all diabetic complications. Therefore, ways to modulate EPCs are~     currently considered of utmost importance, especially in high-risk subjects. While many drugs~     with pleiotropic vasculoprotective effects have shown ability to positively modulate EPCs,~     there is no data on the effects of specific insulin formulations.~      This is a human randomised cross-over comparison trial. The purpose is to compare the effects~     of two basal insulin analogues (detemir and glargine) added to oral antidiabetic therapy in~     poorly-controlled type 2 patients with cardiovascular disease on endothelial function and EPC~     levels.~      The aim is to test whether optimized glycemic control with add-on basal insulin analogues~     improves endothelial damage and regeneration in type 2 diabetes with macroangiopathy and to~     compare the effects of glargine vs detemir on markers of endothelial damage and regeneration.~      EPC level is the most innovative outcome measure of this study and represents the primary~     endpoint. Endothelial dysfunction/damage, evaluated using soluble markers, will be the~     secondary outcome. Given the supposed inverse correlation between EPC and endothelial damage,~     it is expected that EPC increase reflects amelioration in endothelial biology, a result that~     may have significant clinical implications in this cohort of high-risk patients.~   "
218458|NCT00699673|"~     Objective: The purpose of the present study is to assess if perioperative variation of Brain~     Natriuretic Peptide (BNP) levels is a predictor of mortality and morbidity after cardiac~     surgery.Material and Methods: 500 consecutive patients will be enrolled prospectively in this~     study before cardiac surgery under cardiopulmonary bypass. BNP levels will be measured prior~     to surgery and at postoperative day 1. Variations of BNP levels will be analyzed to determine~     if it is a predictor of mortality and morbidity after cardiac surgery. This dynamic~     evaluation will be compared to other tools of risk stratification in cardiac surgery as the~     EuroScore. All patients will be followed 3 years after the procedure.~      Hypothesis: Perioperative BNP variations may be more sensitive than pre- or postoperative BNP~     levels alone. Furthermore the perioperative homeostasis will be measured to assess its impact~     on BNP secretion during the perioperative period.~   "
218459|NCT00699660|"~     This project evaluated the impact of semi-structured, standardized interviews on the initial~     PTSD C&P on the examination.~   "
218460|NCT00699634|"~     The purpose of this proposed study is to conduct a randomized double-blind placebo controlled~     trial assessing the benefit of nabilone in pain management and improvement of quality of life~     in patients with phantom limb pain.~      Our Hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the~     phantom limb pain and improve quality of life, compared to the placebo controlled group. This~     will be evident by finding significant differences in Visual Analogue Scale pain scores,~     frequency of phantom pain episodes, the Depression, Anxiety and Stress Scale, and the~     Groningen Sleep Quality Scale and daily prosthetic wearing time.~   "
218461|NCT00699621|"~     -  To prove whether use of antiplatelet agents results into a rapid enlargement of hematoma~          after onset of acute intracerebral hemorrhage.~        -  To prove the efficacy and safety of platelet transfusion for prevention of hematoma~          growth in patients who were stricken by acute intracerebral hemorrhage while being on~          antiplatelet medication.~   "
218462|NCT00699608|"~     This study will explore potential next-day residual effects of a single evening dose of 3mg~     of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.~   "
218463|NCT00699595|"~     To investigate if labor pain is affected by mother's hormone levels.~      The hormonal effects of pregnancy are well documented. Although differences in pain~     sensitivity between women and men are partly attributable to social conditioning and to~     psychosocial factors, many laboratory studies of humans have described sex differences in~     sensitivity to noxious stimuli, suggesting that biological mechanisms underlie such~     differences. Some animal studies have suggested that sensitivity to pain decreases during~     pregnancy because of the progressive activation of endogenous pain inhibitory systems. This~     effect may be mediated by pregnancy-associated hormones, in particular progesterone.~   "
218464|NCT00699582|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel~     when given as an adjunctive therapy in subjects with refractory partial seizures.~   "
218465|NCT00699569|"~     To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of~     oral mucositis in patients with head and neck cancer undergoing high-dose radiation.~   "
218466|NCT00699556|"~     This study examines the effect of combined nicotine replacement therapy (transdermal patch +~     nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and~     self-administration behavior.~   "
218467|NCT00699543|"~     Objectives~      : To evaluate the clinical efficacy, angiographic outcomes, and safety of the new~     paclitaxel-eluting coronary stent (CoroflexTM Please, B Braun, Germany), compared with~     another paclitaxel-eluting coronary stent system (TaxusTM, Boston Scientific, USA) in the~     treatment of coronary stenosis.~      Study Design~      : Prospective, open label, 2: 1 randomized multi-center trial. Patients will be randomized~     according to the type of drug eluting stent ( CoroflexTM Please vs. TaxusTM). Randomization~     will also be stratified per hospital for the presence of DM and the presence of long lesions~     (lesion length > 28mm)~      Patient Enrollment~      :915 patients enrolled at 13 centers in Korea.~      Patient Follow-Up~      :Clinical follow-up will occur at 1, 4, 9, 12 months and 2, 3years after intervention.~     Investigator or designee may conduct follow-up as telephone contacts or office visits.~      Primary Endpoint~      :Clinically driven Target vessel Revascularization (TVR) at 9 months.~      Secondary Endpoints~      :A. Clinical safety and efficacy end points~        1. Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction~          (Q-wave and non-Q wave), TVR)~        2. Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically~          driven TVR)~        3. Stent thrombosis~      B. Angiographic efficacy end points~        1. in-stent binary restenosis by QCA~        2. in-stent and in-lesion late loss by QCA~        3. in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the~          index procedure and at 9 months of follow-up~   "
218468|NCT00699530|"~     The purpose of this study is to investigate the effects of chronic elevated levels of~     Prolactin on metabolism and insulin sensitivity by studying patients with hyperprolactinemia~     before and after treatment.~   "
218472|NCT00699478|"~     Pernicious anemia develops in 50% of total gastrectomized due to gastric cancer patients.~     Lack of intrinsic factor, which is secreted by parietal cell from stomach wall causes~     deficiency of cobalamin, which, in final, causes pernicious anemia. Thus, patients who had~     undergone total gastrectomy needs to be provided externally with cobalamin. Until now,~     intramuscular injection of cyanocobalamin has been the choice of treatment for cobalamin~     deficiency, but it has demerits in that it causes discomfort of coming to the hospital to get~     an injection, and in its high costs.~      However, in pernicious anemia in old age and absorption disorder patients, it has been~     reported that oral administration of cobalamin had effect of elevating serum vitamin B12.~     Thus, this study was designed to prove the effect of oral administration of vitamin B12 in~     total gastrectomized patients with cobalamin deficiency.~   "
218473|NCT00699465|"~     -  To evaluate the efficacy of using IPC during the acute phase of ICH in the prevention of~          VTE.~        -  To assess the safety and efficacy of additional therapy with enoxaparin.~        -  To compare the efficacy and safety of the European and American guideline~          recommendations.~        -  To provide an efficient and safe thromboprophylaxis for several weeks until the patient~          is able to walk.~   "
218474|NCT00699452|"~     The present study defines a blinded, randomized, placebo-controlled, prospective study, the~     aim of which is to determine the influence of effective treatment with Type 1 angiotensin II~     (Ang II) receptor (AT-1R) antagonist, using candesartan (target dose 16 mg) on stenotic~     aortic valves. The investigators will specifically quantify whether candesartan attenuates~     the key pathogenic mechanisms of aortic valve stenosis, namely inflammation, fibrosis,~     elastin degradation, calcification, and neovascularization.~   "
218475|NCT00699439|"~     The primary idea is that the use of a computerized reminder system to help with the guideline~     implementation will increase utilization and adherence of guideline-driven care, leading to~     improved patient outcomes. The hypothesis we aim to address is that an automatic,~     computerized reminder system for detecting asthma patients in the pediatric ED will increase~     paper-based guideline utilization compared to paper-based guideline without the system.~      We aim to implement a real-time, computerized asthma detection system and integrate the~     system with the pediatric emergency department information system, and evaluate the effect of~     the asthma detection system on reminding clinicians to use the paper-based asthma guideline.~   "
218476|NCT00699426|"~     To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk~     factors on type 2 diabetic patients.~      Study Hypothesis:~        1. Nexium causes an increased gastrin secretion that increases the insulin secretion and~          thereby a reduction of HbA1c~        2. Probiotics changes the gut flora and bloodpressure~        3. Probiotics causes a change in inflammation and thrombosis.~   "
218477|NCT00699413|"~     The purpose of this study is to evaluate the effects of a combination of hydroxcycitrate~     (HCA) and niacin-bound chromium, in conjunction with nutrition education, over a twelve week~     period. Participants will be evaluated with regard to BMI, percent body fat, insulin~     activity, and hunger.~   "
218478|NCT00699400|"~     Phase IV, prospective multicenter, observational Registry will track cycle outcomes for~     subjects who are thawing frozen oocytes for subsequent use through in vitro fertilization~     (IVF) and embryo transfer (ET)~   "
218479|NCT00699387|"~     Background: Chagas disease is a parasitic infection caused by the Trypanosome cruzi. The~     initial phase of the infection happens mainly in children. Up to 10% of infected children~     die. Survivors often develop chronic infection leading to heart disease and other~     complications in 30% of patients. These complications often result in death or severe~     handicaps in early adulthood, depriving societies of individuals in their most productive~     years.~      There are 20 million people infected in Latin America. Complications lead to 20,000 deaths~     every year.~      Treatment during the acute phase with benznidazole leads to a high cure rate. However, there~     are very few studies of this drug and virtually none in children, even though benznidazole~     was developed over 30 years ago.~      Hypotheses and Specific Aims: We hypothesize that the pharmacokinetics of benznidazole in~     children is different from adults, and that obtaining information on how it is absorbed,~     distributed and eliminated in children will allow optimization of treatment of Chagas disease~     in this population. This will in turn improve the outlook for children by reducing mortality~     and long term complications. We aim to study the pharmacokinetics of benznidazole in children~     receiving the drug for treatment of Chagas disease, and to correlate it with treatment~     effectiveness and incidence of adverse effects.~      Potential Impact: This novel knowledge will allow better and more rational approaches to the~     treatment of Chagas disease. It will also set the foundation for further studies that will be~     able to test improved therapies that may increase treatment response in vulnerable children.~   "
218480|NCT00699374|"~     The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally~     once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients~     with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A~     and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be~     given until disease progression, occurrence of unacceptable toxicity, or other withdrawal~     criteria are met. After discontinuation of study treatment, patients will be followed up in~     order to collect information on further antineoplastic therapy and survival.~   "
218481|NCT00699361|"~     Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he~     stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe,~     R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet~     (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a~     highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999).~   "
218482|NCT00699348|"~     This single arm study will assess the efficacy, safety and tolerability of once-monthly~     administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the~     maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia.~     Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will~     receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on~     the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses~     will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per~     deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample~     size is 100-500 individuals.~   "
218492|NCT00699218|"~     This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will~     benefit patients with bipolar depression safely. Based on published studies, this study~     hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some~     patients who have failed at least two medications.~   "
218493|NCT00699192|"~     To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80~     mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and~     amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential~     hypertension. All three regimens are expected to be well tolerated.~   "
218494|NCT00699179|"~     This study is conducted in Europe. This observational study is aimed to reflect the~     post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used~     under normal clinical practice conditions in Serbia.~   "
218495|NCT00699166|"~     This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea~     caused by Irritable Bowel Syndrome in women.~   "
218496|NCT00699153|"~     Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic~     base, when compared to vehicle for the treatment of inflammation following cataract surgery.~   "
218497|NCT00699140|"~     The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the~     treatment of immune thrombocytopenic purpura.~   "
218498|NCT00699127|"~     Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of~     questions, and look for information all the time. Organizing the information given to parents~     could reduce their anxiety. The parents will be divided into two groups: one group will get~     organized information, by a lecture at the first week of their infant's life, and the other~     group will not. Of course, questions will be answered all the time. The parents will answer a~     questionnaire on the first week of the infant's life, and on the last week, just before~     releasing the infant home.~   "
218499|NCT00699114|"~     The purpose of this placebo controlled clinical trial is to evaluate the dose response~     relationship of ibuprofen in doses from 400 mg to 800 mg and paracetamol (acetaminophen)in~     doses from 500 mg to 1000 mg compared with paracetamol (acetaminophen)1000 mg plus codeine 60~     mg on acute postoperative pain after surgical removal of impacted third molars.~   "
218500|NCT00699101|"~     This multiple site, prospective, non-randomized study has been designed to compile~     information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected~     patients through evaluation of dosimetric success as compared with a single central lumen~     balloon device and through treatment outcomes.~   "
218501|NCT00699088|"~     The purpose of this prospective clinical data-collection is to document the performance and~     clinical outcomes of the Balance® Microplasty™ Hip System.~   "
218502|NCT00699062|"~     The distal lung contributes to asthmatic airway remodeling which is observed from early onset~     of the disease. Cysteinyl leukotrienes (CysLT) play important role in the pathogenesis of~     airway remodeling and antileukotrienes work to exert a certain degree of anti-inflammatory~     effect. The cysteinyl leukotriene antagonist Montelukast has been in vivo shown to~     significantly inhibit ovalbumin induced airway smooth muscle hyperplasia and subepithelial~     fibrosis in sensitized mice. This study aims to evaluate if Montelukast could reverse airway~     remodeling in asthma patients by a non-invasive approach-HRCT.~   "
218503|NCT00699049|"~     The purpose of this study is to explore additional benefit of solifenacin after 12-week~     treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.~   "
218504|NCT00699036|"~     The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with~     rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven~     nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are~     there differences in the efficacy (as measured by histopathology and insulin resistance) of~     three different therapeutic modalities used to treat NASH?~   "
218505|NCT00699023|"~     The purpose of this study is to determine whether ezetimibe in association with statins is~     more effective than statins alone on postprandial lipemia in type 2 diabetic patients.~   "
218506|NCT00699010|"~     The purpose of this study is: (1) to assess the effect of oxycodone HCl on niacin-induced~     dysphoric effects when oxycodone HCl is administered in combination with niacin in subjects~     with a history of opioid abuse; (2) to assess the abuse liability of 4 times the usual~     recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40~     mg alone in subjects with a history of opioid abuse.~   "
218507|NCT00698997|"~     Goals of the current project: (1) Does the Early Start Denver Model experimental intervention~     for toddlers with autism reduce disability associated with autism significantly more than~     standard community interventions?; and (2) What environmental, child, and biological~     characteristics mediate and moderate intervention response and outcomes at age 4?~   "
218508|NCT00698984|"~     The purpose of this study is to obtain information about the effect of a combination of~     genistein, PUFAs, vitamin K and D (BONISTEIN(R) bone blend) on bone health, determined as~     bone mass density/content and bone biomarkers after 6-months treatment in 70 healthy~     postmenopausal women. In addition, safety and tolerability will be investigated.~   "
218509|NCT00698958|"~     A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive~     mechanical ventilation in patient with hypercapnic respiratory failure secondary to~     neuromuscular diseases or alterations in thoracic cage in comparison with hospital~     adaptation.~   "
218510|NCT00698945|"~     To assess the additional benefit of common adjunctive classes on the diurnal IOP curve in~     patients assessed as needing additional treatment to reach target intraocular pressure (IOP).~     To demonstrate superiority of IOP control with Istalol 0.5% QD compared to Brimonidine~     Tartrate 0.2% BID as adjunctive therapy in adults with uncontrolled IOP's (determined by P.I.~     based on target pressures) currently treated with Latanoprost 0.05% in the study eye(s).~   "
218511|NCT00698932|"~     Saxagliptin is a new investigational medication being developed for treatment of type 2~     diabetes. This study is designed to evaluate the efficacy and safety in adult patients with~     inadequate glycaemic control with diet and exercise.~   "
218527|NCT00698724|"~     To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone~     versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual~     acuity and OCT measurements.~   "
218512|NCT00698919|"~     Sepsis is a common cause of morbidity and death in intensive care units. Clinical and~     laboratory signs of systemic inflammation, including changes in body temperature,~     tachycardia, or leukocytosis, are neither sensitive nor specific enough for the diagnosis of~     sepsis. The diagnosis of sepsis is difficult, because clinical signs are unspecific. These~     signs include tachycardia, leucocytosis, tachypnoea, and pyrexia, which are collectively~     termed a systemic inflammatory response syndrome (SIRS). SIRS is very common in critically~     ill patients, being found in various conditions including trauma, surgery, burns,~     pancreatitis, post-cardiac arrest syndrome, cardiac surgery. Microbiological culture can be~     used to distinguish sepsis from non-infectious conditions. However, this method lacks~     sensitivity and specificity, and there is often a substantial time delay. So these signs can~     also be misleading because critically ill patients often present with the systemic~     inflammatory response syndrome without infection. This issue is of paramount importance,~     since therapy and outcome differ greatly between patients with and those without sepsis;~     clinicians are often prone to overuse antibiotic therapy being afraid of not treating a~     potential infection or superinfection. Moreover, the widespread use of antibiotics for all~     such patients is likely to increase antibiotic resistance, toxicity, and costs. On the~     opposite, any delay in administration of antibiotics can be extremely detrimental for the~     infected patient with an exponential increase of the odd ratio for death. Search for early~     biomarker tools for the diagnosis of infection, initially promising, are quite challenged and~     controversial nowadays because they can be more related to the inflammation response,~     irrespective to the insult. Furthermore up to 40% of the infections remain strongly suspected~     but not bacteriologically documented. Persisting researches are ongoing to find new markers~     to better discriminate SIRS related to infection process from to SIRS not related to~     infection. Cytokine profiles using multiplex analysis seems more related to the severity of~     the SIRS than the trigger of the SIRS (infectious or non infectious diseases). Thus, new~     tools have been developed to identify bacteria by detecting their DNA by various techniques.~     These techniques have many potential interests over conventional microbiologic tests by~     decreasing turnaround time (within a few hours 2-6 hours), reducing inhibitory effects of~     prior use of antibiotics, detection of slow or fastidious growing organisms. However these~     tests remain to be validated in a clinical setting.~      The goal of the current study is to evaluate the diagnostic value of plasma detection of~     bacterial DNA in ICU patients with a clinical suspicion of bacterial infection.~   "
218513|NCT00698906|"~     This study will evaluate the immunogenicity and safety of different formulations of the~     HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of~     Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose~     of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months~   "
218514|NCT00698893|"~     The purpose of the study is to evaluate the safety and reactogenicity of candidate gD~     vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in~     these subjects will also be evaluated.~   "
218515|NCT00698880|"~     Portal vein embolization (PVE) induces shrinkage of the embolized lobe and compensatory~     enlargement of the non-embolized lobe, but it does not always induce sufficient liver~     regeneration. There was no effective method to accelerate liver regeneration in addition to~     PVE yet.~      This study intends to assess the effect of ipsilateral hepatic vein embolization (HVE)~     performed after Portal vein embolization (PVE) on liver regeneration. During a 1-year study~     period, preoperative HVE would be performed on 10 or more patients who had shown limited~     liver regeneration after PVE awaiting right hepatectomy. Sequential application of PVE and~     HVE may be safe and effective in facilitating contralateral liver regeneration by inducing~     more severe liver damage than PVE alone.~   "
218516|NCT00698867|"~     The purpose of this study is to perform a five-year, multi-center prospective evaluation of~     the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of~     function will determine long-term clinical outcome while durability will be measured by the~     absence of revisions.~   "
218517|NCT00698854|"~     The purpose of this prospective clinical data-collection is to document the performance and~     clinical outcomes of the Vanguard™ Complete Knee System.~   "
218518|NCT00698841|"~     The purpose of this study is to determine whether corrected QT (QTc) interval changes occur~     on an electrocardiogram (ECG) when cetuximab is administered to the study population.~   "
218519|NCT00698828|"~     To evaluate SUN11031 for injection compared to placebo in subjects with cachexia associated~     with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical~     performance and body composition.~   "
218520|NCT00698815|"~     This randomized phase II trial studies pemetrexed disodium and sunitinib malate to compare~     how well they work when given alone or together as second-line therapy in treating patients~     with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as~     pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow~     to the tumor. It is not yet known whether pemetrexed disodium and sunitinib malate are more~     effective when given alone or together in treating non-small cell lung cancer.~   "
218521|NCT00698802|"~     This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose~     control of biphasic human insulin 100 IU/mL and EX1000.~   "
218522|NCT00698789|"~     Determine the effect of treatment with INCB019602 administered as an add-on to stable dose~     metformin therapy in type 2 diabetic subjects on safety and glycemic control.~   "
218523|NCT00698776|"~     This is a single arm open label trial to test the tolerability of the combination of monocyte~     derived DCs loaded with KRN7000 (DC-KRN7000) and Lenalidomide (LEN) in patients with~     asymptomatic myeloma. Phase I component of the study will evaluate the optimal dose of LEN,~     with particular emphasis on safety. After an interim analysis of these data, a single dose~     level will be chosen for phase II component in additional patients.~   "
218524|NCT00698763|"~     The primary objective is to explore the safety of low doses of oral levosimendan in patients~     with recent history of an ischaemic cerebrovascular event (stroke or TIA). The main focus~     will be on the evaluation of proarrhythmic potential of the different dose regimens.~   "
218525|NCT00698750|"~     The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™~     Humeral Resurfacing Head Prosthesis for outcome and durability. Relief of pain and~     restoration of function will determine long-term clinical outcome while durability will be~     measured by the absence of revisions.~   "
218526|NCT00698737|"~     This research study takes place at Wayne State University and will take about 11 weeks to~     complete. This is a treatment research study for individuals who currently have cocaine abuse~     or dependence, and who may also have heroin dependence. The purpose of this study is to test~     whether oral sustained release d-amphetamine (SR-AMP) is safe and more effective than placebo~     for preventing relapse to cocaine use for individuals who abuse or are dependent upon~     cocaine. We are also interested whether, for patients who are dependent on cocaine and~     heroin, whether SR-AMP is safe and effective for preventing cocaine relapse in combination~     with buprenorphine.~   "
218528|NCT00698711|"~     The purpose of this research is to help us study a vaccine treatment for patients with~     prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections~     and other foreign substances. The immune system is made up of many different types of cells,~     which fight infection and disease in your body. A vaccine may stimulate the immune system to~     destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a~     solution given as an injection given into or under the skin. It is made up of several parts.~     The first part is MUC-2, a protein present in many cancers, especially prostate cancer. MUC-2~     is attached to a material called KLH or keyhole limpet hemocyanin. KLH is purified from a~     snail- like marine mollusk called a keyhole limpet and has been used for many years to boost~     immune responses in animals and in people. Attaching MUC-2 to KLH helps the immune system~     react to MUC-2. The mixture of MUC-2 attached to KLH is in turn mixed with a material called~     QS21, from the bark of a tree, which also helps the immune system to make more cancer-~     fighting cells. A vaccine like the one you will receive has been given to laboratory animals~     and been shown to produce an immune response in these animals.~   "
218529|NCT00698698|"~     Diabetes mellitus is becoming a global epidemic. There is a need to devise a non invasive~     method for detection of diabetes and its related complication. Tear proteins are easy to~     collect causing no harm to a patient and different studies indicate that tear proteins of~     diabetic patients are significantly different from non diabetic population. This difference~     in the composition of tear proteins become more pronounced with advancement of diabetic~     retinopathy.~   "
218530|NCT00698685|"~     This study tests the hypothesis that a purely immunosuppressive preparative regimen allows~     engraftment of related or unrelated allogeneic hematopoietic stem cells in subjects with~     high-risk malignancies, without causing the post-transplant myelosuppression (e.g.,~     neutropenia, thrombocytopenia) that occurs with currently used reduced-intensity~     (nonmyeloablative) preparative regimens. This study incorporates both safety and efficacy~     endpoints and evaluates a novel preparative regimen of alemtuzumab plus continuous-infusion~     pentostatin, two immunosuppressive agents with different mechanisms of action, in recipients~     of related or unrelated allogeneic hematopoietic stem cell transplantation.~   "
218531|NCT00698672|"~     The purpose of this study is to compare wear and migration of the following hip prostheses:~        1. Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component~        2. Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput~        3. Spectron EF stem with XLPE cup and 28 mm CoCr caput~        4. Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput~        5. Spectron EF stem with XLPE cup and 28 mm Oxinium caput~   "
218532|NCT00698659|"~     1. To determine the effect of anti-vascular endothelial growth factor (VEGF) on endothelial~          function and on retinal microvasculature~        2. To determine endothelial dysfunction as a marker of early response and as an indicator~          for the development of hypertension and proteinuria in patients treated with anti-VEGF~          agents~        3. To characterize the effect of anti-VEGF therapy on the pulmonary function of patients~          with malignancy (primary or secondary) involving the lung~   "
218533|NCT00698646|"~     The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy~     with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with~     monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70~     years) with stage 1 or 2 hypertension~   "
218534|NCT00698633|"~     The purpose of this prospective clinical data collection is to document the performance and~     clinical outcomes of the M2a- Taper™ Hip System~   "
218535|NCT00698607|"~     Objectives~        1. To evaluate the safety and long-term effectiveness of coronary stenting with the~          Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa~          Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting~          coronary stent system(SECSS) (CypherTM, Cordis Johnson & Johnson, Warren, NJ) in the~          treatment of coronary stenosis.~        2. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with~          12-month clopidogrel therapy.~      Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the~     non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months~     duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized~     in a two by two factorial manner according to the type of drug eluting stent (EECSS vs.~     SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization~     will also be stratified per hospital for the presence of DM and the presence of long lesions~     (lesion length ≥ 28mm)~      Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea.~      Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4,~     and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office~     visits.~      Primary Endpoint~        -  In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs.~          SECSS.~        -  Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven~          target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months~          of clopidogrel therapy~      Secondary Endpoint~        -  All Death~        -  Cardiac death~        -  Myocardial infarction~        -  Target vessel revascularization (TVR) (all and ischemia-driven)~        -  Target lesion revascularization (TLR) (all and ischemia-driven)~        -  Stent thrombosis~        -  Acute success (device, lesion, and procedure)~        -  Bleeding~        -  Cerebrovascular accident~        -  In-stent LL at 9 months~        -  Angiographic pattern of restenosis at 9-month angiographic follow-up~        -  In-stent and in-segment % diameter stenosis (%DS) at 9 months~        -  In-stent % volume obstruction (%VO) at 9 months~        -  Incomplete stent apposition post index procedure~        -  Persisting incomplete stent apposition, late-acquired incomplete stent apposition,~          aneurysm, thrombosis, and persisting dissection at 9 months~   "
218536|NCT00698594|"~     The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and~     annual immunotherapy in children with allergic rhinitis allergic to grass pollens.~   "
218537|NCT00698581|"~     Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited~     number of AEDs are approved for use as monotherapy. The objective of this study is to~     evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure~     patients from combination treatment to monotherapy~   "
218538|NCT00698568|"~     This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine~     with adjuvant in initially HSV seropositive or seronegative subjects who have no genital~     herpes disease.~   "
218539|NCT00698555|"~     This study will evaluate the immunogenicity and safety of different formulations of the~     candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that~     of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal~     dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months~   "
218540|NCT00698542|"~     The Patient Safety Screening Tool (PSST) for Sepsis solution is a tool to assist with the~     early detection of Sepsis and management of the administration of bundle packages as defined~     by the Institute for Healthcare Improvement (IHI). This web based application relies on~     integration with bedside medical equipment (BME) data as well as Lab and Registration data so~     that clinical workflow items can be automated in the fight against Sepsis.~   "
251002|NCT00266578|"~     The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the~     treatment of eosinophilic esophagitis (EE).~   "
218542|NCT00698516|"~     Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both~     endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will~     increase delivery of topotecan to tumor cells and may enhance activity of topotecan in~     patients with previously treated small cell lung cancer and improve progression free~     survival.~   "
218543|NCT00698503|"~     The purpose of this prospective clinical data collection is to document the performance and~     clinical outcomes of the M2a- 38™ Hip System~   "
218544|NCT00698490|"~     The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive~     subjects, the humoral and cellular immune response of herpes simplex candidate vaccines~     containing gD from two different cell lines and using gD-Alum as control.~   "
218545|NCT00698477|"~     Primary Objectives~        1. To identify hypermethylated genes in paired pretreatment breast tumor tissue and plasma~          samples from locally advanced and metastatic breast cancer patients using a known gene~          panel which includes APC1, Cyclin D2, RARB, RASSF1A, Twist, Hin1 and GSTP1.~           Rationale: We and others have determined the optimal panel of genes that are able to~          detect free DNA in plasma and serum. We will determine if the same panel of genes is~          effective for detecting tumor DNA in the plasma of locally advanced and metastatic~          breast cancer patients. Further, to determine if the methylation profile of the plasma~          DNA for these genes is the same or different from the primary tumor at presentation, we~          will analyze the primary tumor DNA from fresh frozen samples.~        2. To identify methylation pattern changes in the same subset of patients' plasma samples~          at 24 hours after completion of cycle 1 of chemotherapy and within 24 hours before cycle~          2.~      Rationale: The optimal timing of sampling for methylation analysis that is reflective of the~     tumors response to chemotherapy is not known. How soon methylation changes are observed,~     whether they are high within 24 hours, as that tumor responds to chemotherapy, or whether~     changes can be observed only some time after one cycle of chemotherapy will be studied. (3)~     To also identify methylation pattern changes in breast tumor tissue after one cycle of~     chemotherapy.~      Rationale: To look for a correlation with plasma methylation patterns~      Secondary Objectives~      (1) To correlate our observed patterns of methylation pre- and post-treatment with clinical~     parameters such as clinical and/or radiological response and patient outcome.~   "
218546|NCT00698464|"~     The purpose of this study is to evaluate the effect of varying degrees of hepatic function~     (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in~     subjects.~   "
218547|NCT00698451|"~     The purpose of this study is to evaluate the response rate (Complete Response (CR) and~     Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in~     patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal~     cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten~     28-day cycles. Patients will be followed for six months following treatment to assess~     progression-free survival.~   "
218548|NCT00698438|"~     the purpose of this study was to compare standard trabeculectomy to the Ex-PRESS mini~     glaucoma shunt implantation under a scleral flap in eyes with open-angle glaucoma.In this~     report, we describe the results of a prospective, randomized trial in which subjects with~     bilateral primary open-angle glaucoma underwent the two procedures in fellow eyes.Design:~     Prospective, randomized clinical trial.~      Participants: 15 subjects with bilateral primary open-angle glaucoma Methods: Subjects~     underwent the two procedures in fellow eyes. Safety and efficacy were evaluated for up to two~     years.~      Main Outcome Measures: Mean IOP and surgical success rates. Results: Mean IOP was similar in~     Ex-PRESS and trabeculectomy eyes at all time points except month 9, when Ex-PRESS eyes had~     lower mean IOP (13.2 mmHg vs 16.5 mmHg, respectively; p=0.025). Percent IOP reduction was~     also similar at all time points except postoperative day 1, when trabeculectomy eyes were~     lower (75.5% vs 65.8%, respectively; p=0.003), likely due to a higher rate of early hypotony~     in trabeculectomy eyes versus Ex-PRESS eyes (47% vs 7%, respectively). Complete (without~     medications) and qualified (with or without medications) successes were more common at all~     IOP cut-off values in Ex-PRESS eyes than trabeculectomy eyes at last visit (p=0.015, p=0.015~     respectively). Postoperative complications were uncommon in both groups, but trabeculectomy~     eyes required more postoperative interventions than Ex-PRESS eyes.~   "
218549|NCT00698425|"~     The purpose of this study is to evaluate the safety and tolerability of a single~     iontophoretic dose of buffered solution administered through the EyeGate® II Drug Delivery~     System in healthy adult human volunteers.~   "
218550|NCT00698412|"~     Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate~     the effectiveness of daily cane use on pain, function, quality of life and energy consumption~     during the gait in patients with knee osteoarthritis.~   "
218551|NCT00698399|"~     This is an observational study examining serum markers in patients who are undergoing either~     a cadaveric liver transplant or a living related liver transplant.~   "
218552|NCT00698386|"~     The primary objective of the study is to evaluate the efficacy of oral Zinc administration in~     new smear positive pulmonary tuberculosis patients. Evidence is available suggesting that~     zinc deficiency rapidly diminishes antibody- and cell-mediated immune responses in both~     humans and animals and renders the individual susceptible to a variety of pathogens. This~     micronutrient has also been found to be useful in the treatment of lung tuberculosis in~     limited number of patients.~      We are conducting this study in category-I patients (As per World Health Organization, Geneva~     classification of tuberculosis) having lung tuberculosis to see the efficacy and also to see~     any change in the immunological parameters.~   "
218553|NCT00698373|"~     L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography~     (PET). The aim of this study was to determine whether PET-CT with 18F-FMT provides additional~     information for the preoperative diagnostic workup as compared with 18F-FDG PET. Tumor uptake~     of 18F-FMT was compared with several immunohistochemical markers including L-type amino acid~     transporter 1 (LAT1).~   "
218594|NCT00697814|"~     Prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes.~     Clomiphene citrate is a well known selective estrogen receptor modulator that increases~     gonadotropin secretion via hypothalamic-pituitary action. We conducted a prospective, open~     label clinical trial of CC to evaluate its effects in reverting persistent HH in male~     patients with prolactinomas under dopaminergic agonist treatment.~   "
251003|NCT00266565|"~     Toxicity of anti-IL-5~   "
218554|NCT00698360|"~     Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients~     with various degrees of renal insufficiency~      Objectives:~      Primary objective: Is there a circadian rhythm of epo and melatonin in patients with various~     degrees of renal insufficiency?~      Primary Objective: Is there a circadian rhythm of epo and melatonin in patients with various~     degrees of renal insufficiency compared to patients with a normal renal function?~      Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various~     degrees of renal insufficiency?~      Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various~     degrees of renal insufficiency compared to patients with a normal renal function?~      Study design: Comparative study in 4 groups with various degrees of renal insufficiency,~     duration for each patient 24 hrs. Total duration of study 12 months, patients admitted to the~     hospital (on nursing ward)~      Study population: Patients with various degrees of renal insufficiency~      Main study parameters/endpoints: Analysis of the existence of a circadian rhythm in patients~     with a normal renal function and in patients with variable degrees of renal insufficiency~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Better knowledge of the circadian rhythm in renal insufficiency. This could lead~     to a more efficient administration of erythropoietin and melatonin in the future.~      Extent of burden is 1 venapunction for placement of infusion needle, the withdrawal of 11~     times 5 ml blood in 24 hrs, continuous measurement of body temperature via capsule, 24-hour~     continuous ambulant blood pressure monitoring.~   "
218555|NCT00698347|"~     The purpose of this prospective clinical data collection is to document the performance and~     clinical outcomes of the M2a-Magnum™ Hip System~   "
218556|NCT00698334|"~     Tuberculosis (TB) is the most common opportunistic infection among HIV infected persons~     living in developing countries. Directly observed treatment, short-course (DOTS) is the~     internationally recommended strategy for the treatment of TB. However, the efficacy of DOTS~     for the treatment of HIV-associated TB is not well studied. This study aims to compare the~     efficacy of thrice weekly DOTS in HIV-infected versus HIV-negative patients with TB.~   "
218557|NCT00698321|"~     This study will evaluate the effectiveness of a school-based HIV/sexually transmitted disease~     prevention program in reducing sexual risk behaviors of youth attending school in Liberia.~   "
218558|NCT00698295|"~     The purpose of this study is to evaluate clinical meaning of EEG changes in~     antipsychotic-treated patients with schizophrenia.~   "
218559|NCT00698282|"~     The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in~     healthy Japanese subjects~   "
218560|NCT00698269|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     safety and efficacy of modern insulins after switch from any other anti-diabetic treatment~     under normal clinical conditions in the Gulf countries.~   "
218561|NCT00698256|"~     The aim was to investigate the effects of the consumption of high doses of plant stanol~     esters on concentrations of serum lipids, carotenoids and fat soluble vitamins. In addition,~     we investigated the metabolism of absorbed plant sterols from intestine without and with the~     consumption of plant stanol esters.~   "
218562|NCT00698243|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) and to~     establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules,~     namely, intermittent, weekly, and continuous in patients with advanced solid tumors or~     lymphoma, namely, intermittent, weekly, and continuous.~   "
218563|NCT00698230|"~     Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin~     therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.~   "
218564|NCT00698204|"~     Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation~     therapy given for treatment of head and neck cancer. These lesions are painful, compromise~     nutrition and quality of life and may necessitate interruptions in radiation therapy, thus~     adversely affecting cancer therapy outcomes. This study examined the use of an~     anti-inflammatory medicine to reduce pain and severity of oral mucositis.~   "
218565|NCT00698191|"~     This study will explore a new approach to treat patients with a medical condition known as~     systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new~     population of cells with capability to restore a normal immune system that will no longer~     attack the body.~      The stated hypothesis is that the SLE condition is caused by an abnormal immune system that~     can be restored by replenishing the body with a new population of progenitor cells.~   "
218566|NCT00698178|"~     Gastroesophageal reflux disease (GERD) is a common and important disorder. Previous studies~     have demonstrated the association of obesity with GERD, and now obesity is regarded as a risk~     factor for GERD. Moreover, body mass index (BMI), an indicator of general obesity, correlates~     with severity of symptoms and degree of erosive esophagitis. Waist circumference, an~     indicator of abdominal obesity, has stronger correlation with intra-abdominal pressure and~     low-grade inflammatory state when compared with BMI. Nevertheless the association of waist~     circumference with severity of GERD has not been studied.~      The primary aim of this study is to compare BMI with waist circumference for their~     independent association with severity of GERD. The secondary aim is to evaluate independent~     risk factors of severity of GERD.~   "
218567|NCT00698165|"~     Objective of study is to assess the costs of care, objective and subjective caregiver burden~     and quality of life in relation to disease severity measured by cognitive function, ADL~     capabilities and presence of behavioral disturbances in Alzheimer's disease~   "
218568|NCT00698152|"~     The purpose of this data collection is to determine long term survival rate of ArComXL®~     highly cross-linked polyethylene~   "
218595|NCT00697801|"~     The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics~     of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.~   "
218596|NCT00697788|"~     Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care~     units. We are studying whether this drug is cardiovascularly safe in pediatric patients who~     have recently been burned.~   "
218597|NCT00697775|"~     In this study the safety and immunogenicity of 2 different formulations of the candidate~     HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to~     that of Engerix™-B in healthy adolescents aged 11 to 15~   "
218569|NCT00698139|"~     Many patients with heart failure are unable to increase their heart rate appropriately when~     their body needs increased blood flow. As a result, they may be unable to mobilize excess~     fluid that their body retains. We hypothesize that we can provide assistance to their body in~     mobilizing this fluid by artificially increasing their heart rate using a pacemaker. We plan~     to conduct a prospective clinical trial to evaluate this hypothesis.~      We will use a cross over design to study patients who already have biventricular pacemakers~     implanted or a narrow QRS and volume overload. We will screen them using a blood test that is~     a rough estimate of volume overload. Patients who meet the inclusion criteria will be~     randomly assigned to have their pacemakers adjusted or to have no intervention during the~     first of 2 visits. They will be unaware of which group they are in. Following adjustment,~     they will be monitored for six hours.~      Prior to the pacemaker adjustment, several tests will be performed to evaluate heart function~     and the levels of hormones related that are affected by heart failure. These tests will be~     repeated at the end of the six hour intervention period in each visit. At the end of the~     visit patients who had their pacemakers adjusted will have it reset to their original~     settings.~   "
218570|NCT00698126|"~     This trial is conducted in Europe. The aim of this observational study is to evaluate the~     incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with~     NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.~   "
218571|NCT00698113|"~     The purpose of this study is to determine how parents of children with cancer rate a~     parent-delivered massage therapy educational program for usability and satisfaction, and if~     massage therapy, provided by parents to their child with cancer, reduce symptoms of anxiety~     and depression in the child, and parenting stress in the parent.~   "
218572|NCT00698100|"~     The overall goal of this study is to find out about the safety of injecting the genes (DNA)~     for human and mouse tyrosinase in patients with melanoma. There is no evidence yet that~     injection of tyrosinase DNA results in any clinical benefit. Tyrosinase is the substance~     found in melanoma cells that helps to produce their black color. The DNA used in this study~     was purified from bacteria which contains the gene for tyrosinase. DNA is material which~     contains the information needed to produce many substances in the body.~   "
218573|NCT00698087|"~     The purpose of the study is to compare the safety, reactogenicity and immunogenicity of~     different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B~     when administered at 0, 2 months with a booster at month 12 if necessary~   "
218574|NCT00698074|"~     The primary aim of this study will be to assess whether Biventricular pacing improves~     exercise capacity, and Quality of Life in patients with symptomatic drug resistant~     Non-Obstructive Hypertrophic Cardiomyopathy, using a Biventricular pacemaker.~   "
218575|NCT00698061|"~     Subjects who had not responded to previous hepatitis B vaccination were vaccinated with~     either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose~     vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation.~     The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine,~     Engerix™-B.~   "
218576|NCT00698048|"~     Patients with severe infection can develop very low blood pressure. There are many mechanisms~     leading to this, and one of them appears to involve a hormone called vasopressin. In children~     as compared to adults, the mechanism and response to low blood pressure are different for~     reasons that are not clear. One possibility is the difference in the production and/or~     response to vasopressin. Vasopressin has become part of the treatment of children with low~     blood pressure in the setting of severe infection, when other treatment has failed, but its~     use is on the basis of animal and adult studies. The exact timing and dose is uncertain.~      In this research study, the patients will receive standard treatment for sepsis and septic~     shock, and the investigators will measure the blood levels of vasopressin and a related~     compound called copeptin (both are required to understand the mechanism of control involved).~     Blood will need to be taken from patients without any sepsis so as to be able to compare the~     values in health and in sickness. The patient groups the investigators have chosen for this~     are those children who will have blood taken anyway as part of their routine care. The aim of~     this study is to develop an understanding of the body's hormonal response (with respect to~     vasopressin) to severe infection in children. The long-term aim is to improve the care of~     critically ill children with severe infection by using the most appropriate dose of~     vasopressin at the most appropriate time.~   "
218577|NCT00698035|"~     The purpose of this clinical research study is to determine whether the ESTRING or a special~     preparation of a testosterone cream inserted vaginally are safe for use in breast cancer~     patients. This study will also evaluate if either of these treatments can improve symptoms of~     vaginal dryness or decreased sexual interest that are related to your treatment for breast~     cancer.~   "
218578|NCT00698022|"~     This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the~     administration of risperidone alone or in combination with mifepristone in healthy adult male~     volunteers to determine the average change in absolute weight at Day 28 compared to baseline.~   "
218579|NCT00698009|"~     Primary:~      Evaluate safety, feasibility, persistence, and anti-tumor effect of infused haploidentical~     donor-derived natural killer (NK) cells and low-dose interleukin-2 (IL-2).~      Secondary:~        -  Quantification of cytokine levels;~        -  Assessment of NK cell immunophenotype and function.~   "
218580|NCT00697996|"~     Rituximab will be tested for its safety and potential efficacy in treating B cell dense renal~     allograft rejection episodes in children receiving renal transplants at Stanford University~   "
218598|NCT00697762|"~     The purpose of the study is to evaluate the effectiveness and safety of adjunctive RWJ-333369~     at a dose of 200 or 400 mg/day in comparison with placebo in Korean and Japanese partial~     epilepsy patients who have poor seizure control with one or two antiepileptics (AEDs).~   "
218599|NCT00697749|"~     This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and~     Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2~     genotype~   "
218614|NCT00697554|"~     The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated~     with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The~     immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as~     the control vaccine~   "
218581|NCT00697983|"~     Background: Osteoporosis is a high-prevalence disease with a strong genetic component.~     Nucleotides, including ATP (adenosine 5'-triphosphate) and its purinergic receptors, play a~     role in bone physiology. Single nucleotide polymorphisms (SNPs) in the P2X7 receptor gene~     were recently found to be associated with fracture risk in a cohort of postmenopausal women.~      Objective: To investigate associations between purinergic receptor SNPs and osteoporosis risk~     in humans. Genetic data from a fracture cohort in the Netherlands with high prevalence of~     osteoporosis will be analyzed. Furthermore, effects of aberrant purinergic receptor~     signalling on bone turnover markers will be assessed ex vivo.~      Design: The cohort will include app. 1,000 fracture patients of 50 years and older, who will~     be recruited at the Maastricht University Medical Center during standard medical follow-up~     after a clinical fracture. The standard medical follow-up includes assessment of bone mineral~     density (BMD) by Dual-Energy X-ray Absorptiometry (DXA), if necessary followed by medication~     for osteoporosis. Prior to medication, blood samples will be collected from fracture patients~     to be genotyped for purinergic receptor SNPs and analyzed for biochemical markers of bone~     turnover. Systemic correlates of osteoporosis will be compared between osteoporotic subjects~     (i.e. low BMD) and non-osteoporotic controls (i.e. normal to high BMD). Subsequently, whole~     blood assays in patient subgroups (n=20 per subgroup), based on BMD and purinergic receptor~     SNPs, will be performed to evaluate ex vivo effects of ATP and related nucleotides bone~     markers.~      Study population: Patients of 50 years and older attending an outpatient osteoporosis clinic~     at the Maastricht University Medical Center for standard medical follow-up after a clinical,~     non-pathological fracture.~      Primary outcome parameters: BMD and purinergic receptor SNPs.~      Secondary outcome parameters: Bone markers.~   "
218582|NCT00697970|"~     The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant~     hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2~     months with a booster at month 12~   "
218583|NCT00697957|"~     Ageing populations have made osteoporosis and fragility fractures a major public health~     concern worldwide. Half of all women and 30% of all men will suffer a fracture related to~     osteoporosis during their lifetime. While medical prevention of this immense problem is~     impossible at population level, it is necessary to find efficient preventive strategies.~     Exercise is one of the major prevention approaches because one reason behind the increasing~     burden of osteoporosis is the modern sedentary lifestyle. However, the optimal type,~     intensity, frequency, and duration of exercise that best enhances skeletal integrity are~     still largely unknown.~      We conducted a 12-month population-based randomized controlled exercise intervention in 120~     premenopausal women. The aim was to investigate the effect of impact exercise on bone mineral~     density, geometry and metabolism in healthy women with the intention of assessing the~     intensity and amount of impact loading with a novel accelerometer-based measurement device.~     Training effects on risk factors of osteoporotic fractures, physical performance and risk~     factors of cardiovascular diseases were also evaluated.~      This study demonstrated that 12 months of regular impact exercise favoured bone formation,~     increased bone mineral density in weight-bearing bones, especially at the hip, and led to~     geometric adaptations by increasing periosteal circumference. Bone adaptations had a dose-~     and intensity-dependent relationship with measured impact loading. Changes in proximal femur~     were threshold-dependent, indicating the importance of high impacts exceeding acceleration of~     4 g as an osteogenic stimulus. The number of impacts needed to achieve this stimulation was~     60 per day. Impact exercise also had a favourable effect on physical performance and~     cardiorespiratory risk factors by increasing maximal oxygen uptake, dynamic leg strength and~     decreasing low-density lipoproteins and waist circumference. Changes were dose-dependent with~     impact loading at wide intensity range.~      Bone adapts to impact loading through various mechanisms to ensure optimal bone strength. The~     number of impacts needed to achieve bone stimulation appeared to be 60 per day, comparable to~     the same number of daily jumps. If done on a regular basis, impact exercise may be an~     efficient and safe way of preventing osteoporosis.~   "
218584|NCT00697944|"~     To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in~     intensive care patients with a sepsis and rising candida colonisation.~      Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome®~     administered with an interval of one week, in patiens with a high risk of developing a fungal~     infection) should decrease the incidence of actual systemic infections.~      The incidence of such actual fungal infections will be assessed directly and its impact on~     patients' survival and intensive care resourches assessed~   "
218585|NCT00697931|"~     The purpose of this study is to compare the immunogenicity and reactogenicity of the~     adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected~     according to a three dose schedule (0, 1, 6 months) in an adult non-responder population~   "
218586|NCT00697918|"~     The purpose of this study is to evaluate the long-term safety of RWJ-333369 at doses between~     200-800 mg/day in Korean and Japanese patients who have completed the preceding study~     (333369-KJ-02).~   "
218587|NCT00697905|"~     The aim of the study is to assess if gemcitabine in combination with carboplatin as 1st line~     chemotherapy in patients with metastatic or recurrent nasopharyngeal carcinoma has reasonable~     efficacy and a favourable toxicity profile that warrants further comparative study. A~     parallel group of randomly selected patients of equal number to the carboplatin and~     gemcitabine combination arm will be treated with the cisplatin and 5-FU combination~     chemotherapy (active control arm).~      The hypothesis is that this combination of chemotherapy is at least as active and less toxic~     than the reference regimen of cisplatin in combination with 5-fluorouracil (5-FU).~   "
218588|NCT00697892|"~     The purpose of the study is to determine in healthy volunteers whether certain anti-HIV~     medications (lopinavir/ritonavir and efavirenz) affect the drug levels of certain~     anti-malarial medications (artesunate/ amodiaquine and artemether/ lumefantrine) and vice~     versa. Since these drugs are degraded using overlapping pathways in the liver, it is~     predicted that changes in both drug level and overall drug exposure will be observed.~   "
218589|NCT00697879|"~     CHR-3996 is one of a new class of anti-cancer agents - histone deacetylase inhibitors (HDACi)~     - that has exhibited pleiotropic activity both in vitro and in vivo against a range of human~     cancer cells. Regulation of the acetylation of both histone and non-histone proteins by~     histone deacetylase enzymes is one of the key mechanisms involved in epigenetic control of~     gene expression. HDACi have demonstrated activity in both in vitro cytotoxicity, and in vivo~     tumour xenograft studies~   "
218590|NCT00697866|"~     The purpose of the present study is to evaluate the immunogenicity and safety of three~     consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate~     vaccine will be assessed using Engerix™-B as control.~   "
218591|NCT00697853|"~     This study is undertaken to assess the immune response and safety profile of 4 lots of the~     novel adjuvanted hepatitis B vaccine that were formulated following different processes, with~     Engerix™-B as the control vaccine~   "
218592|NCT00697840|"~     The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity~     of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when~     administered at 0, 6 months~   "
218593|NCT00697827|"~     The purpose of this study is to evaluate the safety and effectiveness of the In-Space~     compared to the X STOP Interspinous Process Distraction (IPD) device (X STOP) for the~     treatment of patients experiencing intermittent neurogenic claudication secondary to moderate~     degenerative lumbar stenosis at one or two lumbar levels.~   "
218613|NCT00697567|"~     The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is~     to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate~     vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.~   "
218600|NCT00697736|"~     Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in~     particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension~     (PAHT).~      In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the~     other hand, the tracking and the analysis of its effects on the right ventricular function~     are difficult with the conventional techniques.~      So, the analysis of the right ventricular function appears capital, because:~        -  it is recognized like an essential determinant of the symptoms and effort capacity,~        -  its prevalence, physiopathology and prognostic values remain unknown in this pathology,~        -  its interest in the starting of the treatment remains to be specified.~      The aim of this trial is to identify in a population of 150 patients presenting a systemic~     scleroderma without PAHT:~        -  the incidence of a right ventricular dysfonction, evaluated by the analysis of the~          myocardic regional function with myocardial tissular Doppler mode,~        -  the physiopathology of this damage by correlation with the tests of respiratory function~          and the not invasive hemodynamic datas at rest and exercise.~        -  the prognosis value of the abnormalities of the right ventricular function by a~          follow-up of these patients over a 5 years period.~      This trial should allowed to define the place of the new right ventricular function markers~     in the evaluation of the functional consequences, the forecast and perhaps the care of~     systemic sclerodermic patients.~   "
218601|NCT00697723|"~     The aim of this study is to evaluate the different performance of arterial and venous graft~     with intra-aortic balloon pump support following coronary artery bypass.~   "
218602|NCT00697710|"~     The purpose of this randomized, double-blind, placebo-controlled, sequential-cohort,~     dose-escalation study was to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of S-777469, a CB2 cannabinoid receptor agonist, in subjects with mild to~     moderate atopic dermatitis.~   "
218603|NCT00697697|"~     The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic~     children, 12 months to 8 years of age, over a 40-week period.~   "
218604|NCT00697684|"~     This study will examine the safety of clofarabine, TLI and ATG as a reduced conditioning~     regimen prior to allogeneic transplantation. The impact of the conditioning regimen on the~     presence of the circulating regulatory as compared to activated T cell populations will be~     assessed.The recovery of DC populations post-transplant will be examined, along with the~     effect of the regimen on disease free and overall survival.~   "
218605|NCT00697671|"~     The prognosis of pediatric patients with hematologic malignancies whose disease is primarily~     refractory or those who experience a chemotherapy resistant bone marrow relapse is extremely~     poor. When new agents or chemotherapeutic regimens are unable to induce remission in this~     patient population, hematopoietic stem cell transplant (HSCT) is also a poor alternative.~     Thus, in this very high risk group, additional attempts at remission induction with various~     combinations of chemotherapy alone will unlikely improve outcome and will contribute to~     overall toxicity. Alternative therapies are needed in these patients with chemotherapy~     resistant disease.~      Immunotherapy with natural killer (NK) cell infusion has the potential to decrease toxicity~     and induce hematologic remission. NK cells can kill target cells, including leukemia cells,~     without prior exposure to those cells. In patients undergoing allogeneic HSCT, several~     studies have demonstrated the powerful effect of NK cells against leukemia. Furthermore, NK~     cell infusions in patients with primary refractory or multiple-relapsed leukemia have been~     shown to be well tolerated and void of graft-versus-host disease effects. In this high risk~     group, complete leukemic remission has been observed in several of these patients after NK~     cell infusion.~      With the current technology available at St. Jude, we have developed a procedure to purify NK~     cells from adult donors. This protocol will assess the safety of chemotherapy and IL-2~     administration to facilitate transient NK-cell engraftment in research participants who have~     chemotherapy refractory hematologic malignancies including acute lymphoblastic leukemia,~     chronic myelogenous leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, or~     non-Hodgkin's lymphoma. In this same cohort, we will also intend to explore the efficacy of~     NK cells infused in those participants who have chemotherapy refractory disease.~   "
218606|NCT00697658|"~     The purpose of this study is to explore efficacy, tolerability and safety of paliperidone~     Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone~     ER in a naturalistic setting.~   "
218607|NCT00697645|"~     This study will determine the safety and efficacy of transcranial magnetic stimulation (TMS)~     in treating acute ischemic stroke (stroke resulting from a blood clot in the brain).~      TMS was found to be effective and safe in the set up of depression. TMS acts by generating~     magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal~     activity translating into increased secretion of growth factors such as brain derived~     neurotrophic factor (BDNF). This is followed by positive effects of these growth and survival~     factors on neuronal sprouting, re-organization and also potentially on neurogenesis. Hence it~     is postulated that TMS will have a positive effect on the recovery rate and extent of~     recovery after stroke. Brainsway innovative project involves the development and use of deep~     Transcranial Magnetic Stimulation in humans to treat a host of behavioral disorders,~     including depression and addiction. Brainsway developed a novel coil design for stimulation~     of deep structures in the human brain and conducted several safety and efficacy studies and~     recently completed a large study (70 subjects) demonstrating effectiveness in depressive~     patients. Deep TMS produces directed electromagnetic fields that can induce excitation or~     inhibition of neurons deep inside the brain. The treatment is non-invasive, with no~     significant side effects, and no need of hospitalization or anesthesia. Consistent with~     animal studies using brain stimulation deep TMS of the prefrontal cortex was found to exert~     potent antidepressant effects on patients not previously responsive to antidepressant drugs~     in two different studies. Therefore, it is expected that TMS will also be safe in patients~     with stroke.~      Patients between 18 and 80 years of age who have had a mild or moderate acute stroke may be~     eligible for this study. Candidates will be screened with a medical history and physical~     examination, blood tests, rating of neurological deficits such as cognition deficits or~     problems walking that resulted from the stroke, and a computed tomography (CT) or a magnetic~     resonance (MRI) scan of the head. CT involves the use of specialized X-rays and MRI involves~     a magnetic field to obtain images of the brain.~      All participants will receive standard medical and rehabilitation therapy for stroke. In~     addition, patients recruited for the study will receive x sessions of TMS with the Brainsway~     device delivered over the motor strip of the affected hemisphere. Each session will last for~     y minutes. Sessions will begin on day 3 after stroke onset and will be given on an alternate~     day basis for 14 days (7 treatments). Patients will be monitored daily until discharge from~     the hospital, or until day 17, whichever is earlier. Assessments will include physical~     examinations and safety evaluations including blood tests to and MRI or CT scans to evaluate~     both the response to treatment and side effects if needed. Patients will return for a~     follow-up examination 30 and 90 days after treatment conclusion to evaluate their recovery~     rate and functional status.~   "
218608|NCT00697632|"~     In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients~     with advanced malignancies to study its safety profile.~   "
218609|NCT00697619|"~     The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic~     treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy~     variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal~     patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic~     treatment alone.~   "
218610|NCT00697606|"~     Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such~     diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and~     surgeons suffer when adhesions are encountered, since the surgery becomes more intense,~     lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in~     gynecologic and abdominal surgery. Limited data is available on the effectiveness of~     Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean~     section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex,~     with difficult lysis of adhesions being the cause of morbidities such as bladder damage,~     increased blood loss, and longer operating times. The objective of this definitive project is~     to define the extent of reduction of adhesion formation of Seprafilm® when used at the time~     of primary cesarean section. Women undergoing primary cesarean section will be randomized for~     Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be~     determined.~   "
218611|NCT00697593|"~     To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic~     or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or~     phototherapy dose.~   "
218612|NCT00697580|"~     We are conducting an intervention study to examine the effects of a 16-week exercise and diet~     interventions on prevention of disease, specifically type 2 diabetes and heart disease, in~     Latino youth. Eighty overweight Latino boys and girls will be recruited and placed in one of~     the following intervention groups: 1) Control Group (delayed intervention), 2) Dietary~     Education Group (nutrition education focused on reducing sugar & soda, increased fiber &~     whole grain intake), 3) Combination of Strength Training (twice/week for 60 min, progressive~     increases in exercise volume and intensity) + Dietary Education (nutrition education focused~     on reducing sugar & soda, increased fiber & whole grain intake) or 4) Combination of Circuit~     Training (twice/week for 60 min, aerobic + strength training exercises) + Dietary Education~     (same as above). We will assess which intervention group has the most effects on health~     parameters such as weight, body composition, and insulin related measures.~   "
218618|NCT00697502|"~     Hypothesis:~      Patients with TYMS 2R/2R or 2R/3R appear to be more sensitive to fluoropyrimidines,~     conferring a higher risk of grade 3-4 fluoropyrimidine related toxicity and a higher response~     rate compared with 3R/3R. The genotype 3R/3R is more common in East Asia and is associated~     with greater tolerability to fluoropyrimidine as measured by lower toxicity but also lower~     response rates. As sensitivity to fluoropyrimidine appears to be affected by TYMS genotype,~     we hypothesise that patients with TYMS 3R/3R are more tolerant to standard doses of~     capecitabine and require higher doses to overcome fluoropyrimidine resistance. We designed~     this study to develop TYMS genotype specific dosing of capecitabine.~      Aims:~        1. To determine the maximal tolerated dose (MTD) of capecitabine twice a day for two weeks~          followed by one week rest period (intermittent schedule) in patients with the advanced/~          and or metastatic cancer based on TYMS genotype.~        2. To determine a suitable phase II dose of intermittent schedule capecitabine.~        3. To determine the safety and toxicity of this regimen.~        4. To perform plasma pharmacokinetics of capecitabine.~        5. To determine the relationship between genes of relevance in the fluoropyrimidine pathway~          with pharmacokinetics and toxicity.~   "
218619|NCT00697489|"~     The incidence of pelvic organ prolapse (POP) in parous women is estimated over 50%. A variety~     of urinary, bowel and sexual symptoms may be associated with POP. Moreover, a proportion of~     women who underwent a surgical correction of POP may occur post-surgical urinary incontinence~     and, thus, if this last presents as genuine stress-type or mixed-type, a second surgical~     intervention may be required. At this proposal, with the aim to reduce the incidence of~     postoperative urinary incontinence, the addition of a preventive continence procedure to a~     POP repair intervention has been widely proposed, but the potential benefits needs to be~     balanced against potential disadvantages.~      Based on these considerations, the aim of this trial will be to compare two different~     surgical strategies for women with POP without urinary stress incontinence. Specifically, the~     efficacy to associate and to follow a preventive continence procedure to the correction of~     POP will be compared.~   "
218620|NCT00697476|"~     The purpose of this study is to evaluate the maximum tolerated dose, the activity and the~     safety profile of the combination of vorinostat and topotecan in patients with recurrent~     small cell lung cancer~   "
218621|NCT00697463|"~     Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young~     individuals sustain one or more low-trauma fractures. Teriparatide [PTH(1-34)], which is FDA~     approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating~     bone formation. We hypothesize that teriparatide will significantly increase bone density~     (BMD) and improve bone structure in premenopausal women with IOP.~   "
218622|NCT00697450|"~     This study is conducted in Europe. Observational study evaluating the body weight progress~     during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated~     with other basal insulins~   "
218623|NCT00697437|"~     Primary Objective:~        -  To confirm if ketoconazole inhibition of CYP3A activity affects fractional excretion of~          docetaxel in the urine.~      Secondary Objective:~        -  To compare the metabolite ratios of the major metabolites of docetaxel in the presence~          and absence of CYP3A inhibition.~   "
218624|NCT00697424|"~     Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of~     the population and is characterised by loud snoring, periodic collapse of the upper airway~     particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. Health~     consequences include impaired cognitive functioning, quality of life, mood, and increased~     cardiovascular disease risk. Epidemiological studies have demonstrated that increased~     morbidity and mortality in a dose response manner with increasing severity of sleep~     disordered breathing.~      The standard treatment for OSA is nasal Continuous Positive Airway Pressure (CPAP), which~     consists of pressurized air applied to the nose via a mask. Generally a single, optimal~     pressure is prescribed for a patient based on a full night or partial night study during~     which the pressure is adjusted by a technician until all sleep disordered breathing (SDB)~     events are abolished. Despite therapy efficacy, compliance to CPAP therapy is sub-optimal.~      Due to low compliance it has become common for healthcare providers to follow up subject~     therapy efficacy through reporting software inherent in many current CPAP devices. Healthcare~     providers can use this reported data to make appropriate treatment decisions. For this reason~     the data needs to be accurate. The SleepStyle™ 200 Auto Series CPAP humidifier is an auto~     adjusting CPAP which stores comprehensive compliance data. The aim of this study is to~     compare the reliability of the SleepStyle™ 200 Auto Series CPAP data to laboratory-based PSG~     in detecting sleep disordered breathing.~      Hypothesis: The SleepStyle™ 200 Auto Series reporting features accurately detects indices of~     sleep disordered breathing.~   "
218625|NCT00697411|"~     Based on our current understanding of Aicardi syndrome, the condition is hypothesized to~     occur due to a genetic change on the X-chromosome. Our team is investigating Aicardi syndrome~     to identify the specific gene location associated with the disorder. We are collecting blood~     and skin biopsy samples from patients and their parents. A permanent cell line is prepared~     and DNA from the blood and skin samples and cell lines is isolated and then used for genetic~     testing. Our current research includes microarray analysis which we are using to look for~     duplications or deletions of genetic material, mutation analysis of candidate genes by~     sequencing, review of medical records to identify trends suggesting possible candidate genes~     of interest, and X chromosome inactivation studies.~   "
218626|NCT00697398|"~     Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic~     stimulation (rTMS) was thus suggested in this indication.~   "
218627|NCT00697385|"~     The high percentage of failure using available non-surgical options to treat menorrhagia in~     women with bleeding disorders shows a continuing need for innovative treatments. This has led~     to development of this protocol in order to make available tranexamic acid as a potentially~     effective menorrhagia therapy option in women with an underlying bleeding disorder. We~     anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in~     bleeding disorder patients.~   "
218682|NCT00696657|"~     This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly~     to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or~     liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was~     double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy~     parameter was HbA1c and the treatment duration was 12 weeks.~   "
218628|NCT00697372|"~     BACKGROUND:~      Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The~     selection of the type of DES and the technique for stent implantation have not been~     clarified. The side-branch (SB) is emerging as critical point, accounting for more than a~     third of the significant restenosis in the DES era. A series of data supports the adoption of~     a conservative strategy: stenting the main vessel (MV) only and reserving a conservative~     approach on the SB. Yet, the clinical relevance in terms of inducible ischemia of sub-optimal~     angiographic result has not been clarified.~      AIMS OF THE STUDY:~      The aims of the present study are:~        1. to compare in a prospective randomized study the acute 3D angiographic results and the~          late clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting stent (EES)~          obtained using a provisional TAP-stenting technique.~        2. to prospectively assess the clinical relevance (inducible ischemia) of suboptimal~          angiographic result in the SB after stenting.~      METHODS TO BE APPLIED:~      150 consecutive patients with bifurcated lesions undergoing PCI with the provisional~     TAP-stenting technique will be randomized to SES or EES implantation. Procedural and post-PCI~     details will be prospectively recorded. The subgroup of patients in which complete~     revascularization has been achieved will enter a systematic assessment of inducible ischemia~     by early and late exercise tests.~      Off line 3D QCA assessment will be performed and used to divide the study population in 2~     groups according to the SB residual stenosis:~        -  Group O (optimal SB angiographic result): post-PCI SB area stenosis<50%~        -  Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis>50%.~      PRIMARY STUDY END-POINTS.~        1. COMPARISON BETWEEN SES AND EES:~           SB acute angiographic result; SB trouble; target bifurcation failure.~        2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization:~          inducible ischemia at the early exercise test or occurrence of early spontaneous~          ischemia related to the SB.~   "
218629|NCT00697359|"~     The primary aim of the study is to assess the efficacy of continuous rhythm monitoring with~     an implantable loop recorder (ILR) compared to conventional ambulatory electrocardiography in~     detecting episodes of atrial fibrillation after pulmonary vein isolation (PVI). The secondary~     aim is to assess the efficacy of PVI during a two years follow-up and to assess the~     reliability of the implantable loop recorder in detecting atrial fibrillation.~      50 patients will be enrolled into the study. After enrollment an implantable loop recorder~     will be implanted at least 6 weeks before scheduled PVI. All patients will be followed for 24~     months after PVI. During the follow-up period a 72-hours ambulatory electrocardiographic~     monitoring will be performed at 1, 6, 12, 18, and 24 months. Transthoracic echocardiography~     will be performed at enrollment, 3, 12, and 24 months after PVI. Moreover, quality of life~     will be assessed at baseline, and 6 and 12 months after PVI.~   "
218630|NCT00697346|"~     This is an open-label, multicenter, phase 1 study of MLN8237 in participants with advanced~     hematological malignancies for whom there are limited standard treatment options.~   "
218631|NCT00697333|"~     Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on~     a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic~     tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of~     FDG-positive lesions.~      Primary endpoint is the local disease control in the chest.~   "
218632|NCT00697320|"~     This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to~     observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German~     clinics. The observational study observes patients with congenital haemophilia with~     inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII~     deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven®~     for treatment of a bleeding episode or for the prevention of a bleeding when undergoing~     surgery or an invasive procedure.~   "
218633|NCT00697307|"~     The purpose of this study was to determine the bioequivalence of a norelgestromin/ethinyl~     estradiol (NGMN/EE) transdermal contraceptive system.~   "
218634|NCT00697294|"~     Vitamin D deficiency is widespread and linked to decreased bone mineral content. Little data~     exists regarding the vitamin D status and the relationship of 25-hydroxyvitamin D (25-OHD)~     status to functional bone health outcomes in Hispanic infants. To evaluate this, we plan an~     observational cohort of full term, healthy, exclusively breastfed Hispanic and Caucasian~     infants. We hypothesize serum 25-OHD measured in cord blood will be significantly lower in~     Hispanic than Caucasian infants, with 25-OHD less than 20 ng/mL found in at least 50% of~     Hispanic neonates. Secondary aims evaluate the relationship between 25-OHD levels and bone~     mineral status at baseline and after 3 months of 400 IU/day supplemental vitamin D3. Whole~     body bone density scan (DXA) and bone ultrasound (SOS U/S) will be measured shortly after~     birth, then again after supplementation. Data from this study will provide information needed~     to design further randomized trials and interventions.~   "
218635|NCT00697281|"~     The primary objective of this study is to evaluate a range of dose levels for efficacy in the~     control of symptoms of allergic rhinitis~   "
218636|NCT00697268|"~     This study will compare levels of p11 protein in people with and without major depressive~     disorder (MDD) and examine if p11 levels in patients are affected by treatment with~     citalopram (Celexa).~      Healthy normal volunteers and patients with chronic or recurrent major depression between 18~     and 65 years of age may be eligible for this study.~      Participants undergo the following tests and procedures:~      Healthy Volunteers~        -  Psychiatric interview and medical examination, questions about family history~        -  Blood draw~      Patients with MDD~      Phase 1 - Evaluation and Discontinuation of Medications~        -  Physical examination, electrocardiogram, blood tests~        -  Gradual antidepressant medication withdrawal, followed by 2- to 6-week drug-free period.~          If needed, medicines for anxiety and difficulty sleeping may be prescribed.~      Phase 2 Citalopram Treatment~        -  Start daily citalopram treatment~        -  Evaluations at the start of phase 2 and every week for 8 weeks with following~          procedures:~        -  Symptoms ratings interview and questionnaires~        -  Review of side effects and new medications~        -  Blood pressure and pulse measurements~        -  Blood and urine tests~      At the end of the study, plans are developed for long-term treatment and transfer of care to~     the patient s own physician.~   "
218637|NCT00697255|"~     The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286)~     regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily~     dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone~     (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm~     at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.~   "
218638|NCT00697242|"~     In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B~     vaccines with and without MPL will be evaluated in older healthy subjects~   "
218639|NCT00697229|"~     The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of~     MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in~     healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months~   "
218641|NCT00697203|"~     This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with~     pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised~     to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po~     daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The~     anticipated time on study treatment is 3 months and the target sample size is 100-500~     individuals.~   "
218642|NCT00697190|"~     This study will evaluate the fitting characteristics and physiological response of two toric~     lenses manufactured by Vistakon.~   "
218643|NCT00697177|"~     Gastric reflux into the oesophagus may further lung damage in respiratory disease. The~     proportion of adults with chronic lung disease and gastric reflux is unknown. Adults with~     this disease regularly complete physiotherapy but the contribution of physiotherapy to reflux~     is unknown. This study will measure gastric reflux in adults with chronic lung disease, using~     24 hour acid monitoring. It is anticipated that approximately 50% of adults with chronic lung~     disease will have gastric reflux. After monitoring, the number of gastric reflux episodes~     will be calculated. The results will identify the extent of the gastric reflux problem in~     these patients and will enable appropriate medical treatment and modifications to~     physiotherapy, which may improve lung function and quality of life.~   "
218644|NCT00697164|"~     Malaria remains one of the most common life-threatening illnesses in the tropics with a~     dramatic toll of more than one million deaths each year. A majority of malaria cases are~     non-complicated and only few evolve towards severe malaria resulting from the combination of~     parasite-specific virulence factors and host inflammatory responses. Cerebral malaria (CM)~     kills more than 1 million African children each year. CM carries a fatality rate of about 20%~     in adults, higher in children, despite timely and adequate chemotherapy. Moreover, the more~     rapid clearance of parasitaemia with new antimalarial drugs is not associated with improved~     survival, suggesting the potential interest for adjunctive therapies in the early phase of~     the disease.~      Cerebral malaria leading to seizure and coma is associated with severe intracranial~     hypertension caused by brain-swelling. Recent imaging and post-mortem findings in adult~     cerebral malaria have confirmed the presence of diffuse cerebral oedema with thalamic and~     cerebellar white matter hypoattenuation, diffuse petechial hemorrhages and symmetric ischemic~     changes involving the thalamus and the cerebellum. However, the nature of the pathogenetic~     processes leading to cerebral malaria is incompletely understood but mechanisms linking~     cytokines with endothelial cells activation in the cerebral microvasculature have been~     recently stressed. The effect of new neuroprotective therapies has not yet been investigated,~     although the manifestations of cerebral malaria partly share features with neurological~     stroke or acute non-specific neurological disorders. The hormone erythropoietin (EPO) is~     probably one of the more enthusiastic drugs in this area.~      EPO is as a member of type I cytokine superfamily with multiple functions, including a~     prominent role for erythropoiesis and neuroprotection. Systematically administered EPO~     crosses the blood brain barrier via the abundant expression of EPO receptors at brain~     capillaries, and acts as an anti-apoptotic and cytoprotective cytokine. Moreover, EPO~     prevents inflammation by inhibiting pro-inflammatory cytokines including TNFα, preserves~     endothelial cells integrity and prevents blood-brain barrier permeability. We propose a~     randomized clinical trial to investigate the safety and efficacy of EPO in patients~     presenting cerebral malaria and hospitalized at Gabriel Toure hospital, Bamako, Mali, to~     reduce the incidence of premature death in hospitalized patients.~   "
218645|NCT00697151|"~     The study sought to assess the rate of recurrent stroke and death in stroke patients with a~     patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter~     study conducted at 48 U.S. Institutions.~   "
218646|NCT00697138|"~     Cocaine dependence is a significant public health concern. The proposed research will provide~     important clinical information regarding the efficacy of agonists replacement therapies for~     managing cocaine dependence.~   "
218647|NCT00697125|"~     The purpose of this study is to evaluate the immunogenicity and reactogenicity of various~     formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult~     volunteers following the 0, 1, 6 months schedule~   "
218648|NCT00697112|"~     The purpose of this observational study is to examine the clinical outcomes of the use of~     sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD)~     under conditions of routine clinical practice. The primary objective is to identify the~     current criteria/reasons to use sirolimus as base therapy in this selected population and~     define and understand the emerging patterns of immunosuppressive treatment with sirolimus.~   "
218649|NCT00697099|"~     The primary objective was to compare the efficacy of once daily [q.d.] subcutaneous [s.c.]~     injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the~     prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective total hip~     replacement surgery.~      The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing~     elective total hip replacement surgery, and to document AVE5026 exposure in this population.~   "
218650|NCT00697086|"~     The purpose of this study is to assess the efficacy of dronedarone for the control of~     ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to~     assess the tolerability of dronedarone in the target population.~   "
218651|NCT00697073|"~     This study is meant to assess the safety and tolerability of idebenone in patients with~     Friedreich's Ataxia over a 12 months period.~   "
218652|NCT00697060|"~     Protocol AMP-024 is a Phase 2 study of imexon plus docetaxel for patients with previously~     treated lung cancer that has spread in the body. Docetaxel is approved by the Food and Drug~     Administration (FDA) as a second line therapy for this cancer. The imexon is administered on~     days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is~     to determine if the combination of imexon plus docetaxel is safe and effective.~   "
218653|NCT00697047|"~     SOS is a four-arm randomized controlled study of ways to increase screening for colorectal~     cancer. About 40-50% of the people age 50 and older are not up to date on screening. This is~     a very important problem because screening both prevents colorectal cancer and decreases~     colon cancer deaths.~      We are studying 3 different levels of support to help people get screened and follow-up after~     positive screening tests. These involve comparing to usual care stepwise increasing in~     intensity approaches; an automated approach of mailing information and home screening tests,~     this plus phone assistance by a medical assistant, both of these plus phone counseling and~     care management. We will also compare nurse assisted follow-up after a positive screening~     test compared to usual care~      By doing this study we hope to increase colon cancer screening rates, and also follow-up~     rates for positive screening tests.~   "
218654|NCT00697034|"~     The purpose of this research study is to examine the role of nerves in the skin in psoriasis~     and to better understand the effects of capsaicin in psoriasis.In this study, capsaicin will~     be compared to a moisturizer (aquaphor ointment).~   "
218735|NCT00695955|"~     This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan~     medoxomil in individuals with essential hypertension.~   "
218655|NCT00697021|"~     TEG is an established technique to assess the quality of clot formation' used mainly in~     surgery and obstetrics to determine possible bleeding diathesis. Recently it became to be~     used in cardiology, where it can be a valuable tool to assess a response to antiplatelet~     therapy and its association with the outcome. However, there is a few data about use of TEG~     in STEMI patients undergoing PCI. Our study is designed to assess by TEG the platelet's~     response to clopidogrel treatment during acute STEMI in patients undergoing primary PCI and~     the correlation of this response with the long term outcome, and ability to dose adjustment~     according to a specific measurement by TEG in order to prevent future MACE.~   "
218656|NCT00697008|"~     To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP~     Guideline.~   "
218657|NCT00696995|"~     This study is conducted in Europe. The aim of this observational study is to evaluate the~     incidence of serious adverse drug reactions when initiating or switching to insulin therapy~     with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions~   "
218658|NCT00696982|"~     Recently a new category of antihyperglycemic therapy aiming to modulate the incretin system~     has emerged. These drugs induce insulin secretion without inducing hypoglycemia. The effect~     of the incretin modulators drugs on hypertension, arterial stiffness, inflammation and~     oxidative stress parameters have not been fully investigated yet.GLP-1 analogue has been~     suggested to have an effect on endothelium and the development of hypertension. Nystrom et al~     have demonstrated that GLP-1 improves endothelial dysfunction in a small group of type 2~     diabetes subjects, with coronary heart disease. We hypothesize that DPP-4 inhibitor will have~     an effect on hypertension and arterial stiffness by effect on the NO pathway.The aim of this~     study is to investigate the effect of two insulin inducers drugs, sulfonyl urea and DPP-4~     inhibitor on 24 hours blood pressure monitoring, arterial stiffness, oxidative stress and~     inflammation.~   "
218659|NCT00696969|"~     The overall objective of this trial is to identify a safe and effective combination,~     (coadministration) short course treatment for the treatment of visceral leishmaniasis which~     could be easily deployed in a control programme and will reduce the risk of parasite~     resistance occurring.~      Safety and tolerability should be such that the combination can be easily deployed.~   "
218660|NCT00696956|"~     The study will be performed as a randomized, double blind trial (in respect of the primary~     end point) with treatment of the stenotic lesion using uncoated PTA-catheters as control~     group. 114 patients will be included in the trial at about 5 study centers. Follow-up~     includes control angiography after 6 and 18 months and clinical follow-up examinations up to~     18 months. Primary objective:~      Efficacy of paclitaxel coated PTA balloons in inhibiting restenosis of below the knee~     arteries (late lumen loss)~      Secondary objective:~      Various angiographic and clinical efficacy measures, safety and tolerance of pacli-taxel~     coated PTA balloons in inhibiting restenosis of below the knee arteries Descriptive~     statistics, comparison by t-test, chi-square test for binary events 10.1 Descriptive~     statistics As far as applicable descriptive statistics will be applied to data and will be~     referring to individual changes versus baseline (predilatation or immediately~     postdilatation). The groups will be compared to each other testing the statistical~     significance of differences (p ≤ 0.05). Con-tinuous data will be expressed as mean ± standard~     deviation.~      Categorical variables will be compared using the chi-squared test, and continuous variables~     will be compared using Student's t test or ANOVA analysis.~      In addition to the assessment of the primary endpoint and the secondary endpoints a~     multi-variate analysis to investigate the influence of risk factors on the interventional~     outcome (interventional success, early restenosis/occlusion, LLL, stent integrity) and~     clinical outcomes will be performed. For this analysis the following factors will be~     considered: age, diabetes, neurological status (only Rutherford 5), lesion length, grade of~     dissection and calcification, reststenosis, number of run-off vessels, stent administration~     in the index lesion(s).~      10.2 Estimated number of patients The primary endpoint of the study is late lumen loss (LLL)~     at 6 months evaluated by quantitative angiography. Because no data according this endpoint~     are available for both the control group and the group which will be treated with the~     paclitaxel coated balloon an assumption according the LLL at 6 months was made according the~     expectations of the principle investigator. An estimate for LLL as % of MLD in the control~     group is 50% and in the drug coated balloon group 30 %. The standard deviation is calculated~     to be 30% of LLL. A sample size of 37 patients in each group will allow the detection of a~     statistically significant difference (p<0.05) with 80% power. Based on the Below study~     which enrolled patients with comparable arterial lesions in Tuebingen and the data of the~     Basil study, it is estimated that 35% of the patients who will be enrolled in the study will~     not be available for follow-up investigations in order to calculate the MLD.~      In order to meet a statistical endpoint a total of 114 patients will be enrolled.~   "
218661|NCT00696943|"~     The purpose of this study is to evaluate the potential of [18F]-ML-10 to serve as a~     non-invasive imaging tool for the early detection of apoptosis in brain metastases in~     response to radiation therapy, in patients subjected to stereotactic radiosurgery (SRS). Such~     early detection may improve clinical management of patients with brain metastases, as it may~     help early identification of non-responders, and subsequently potentially lead to~     optimization of radiation techniques such as the need for whole brain radiation therapy~     (WBRT), addition of brain penetrating chemotherapy or an early decision on referral of the~     patient with non-responsive lesions to surgery or to systemic chemotherapy. The experimental~     design of the present study aims to evaluate the potential of non-invasive PET examination~     with [18F]-ML-10, to provide the clinician with an assessment of response early in the course~     of treatment, via non-invasive molecular imaging of radiation-induced apoptosis. This~     information on tumor responsiveness is currently available only several weeks to months after~     completion of radiotherapy.~   "
218662|NCT00696930|"~     Subjects will be screened to determine OctreoScan® uptake. And upon meeting the eligibility~     criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the~     study at specific time points. Actual treatment will consist of three six-week cycles of a~     fixed total dose of 13.3 GBq (360 mCi) of 90Y-SMT487. The total dose will be divided into~     three equal doses and administered as a single activity of 4.4 GBq (120 mCi) of 90Y-SMT487~     once every six weeks for three cycles. An amino acid infusion will be administered along with~     each dose. Long-term follow up will occur at 6 and 12 months after Day 1/ Cycle 1. Survival~     will be assessed every six months.~   "
218663|NCT00696917|"~     This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL~     vaccine and to compare their safety and immunogenicity with that of Engerix™-B.~   "
218664|NCT00696904|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333~     in healthy volunteers and the antiviral activity in HCV infected subjects.~   "
218665|NCT00696891|"~     This study is conducted to compare the immunogenicity, reactogenicity and safety of~     Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population~   "
218666|NCT00696878|"~     The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin~     alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated~     COS cycles using a multiple dose GnRH antagonist protocol.~   "
218667|NCT00696865|"~     This multiple ascending dose study will evaluate safety and tolerability after repeated~     ascending doses of AZD2624~   "
218668|NCT00696852|"~     In this study, we will conduct a preliminary, yet comprehensive evaluation of Mindfulness and~     Yoga, as compared to an exercise and education-based stress-reduction program. and~     simultaneous evaluation of the effect of an 8 week program of Mindfulness, 12 weeks of Yoga~     practice, and 12 weeks of an exercise and education-based program.~      105 otherwise healthy individuals, who have cardiovascular risk factors and mild to moderate~     stress or anxiety will be randomly assigned to one of the three intervention groups: an 8~     week program of Mindfulness, 12 week program of Yoga practice, and 12 week exercise and~     education-based group program. All subjects will perform daily practice that will continue~     after the weekly sessions end, allowing a follow up assessment at 24 weeks. Self-reported~     mood and psychological distress and physiological indicators of function of the ANS and~     stress hormones will be assessed at baseline, 8 weeks, 12 weeks and 24 weeks. Blood and urine~     samples will be collected at baseline and 8 weeks to determine levels inflammatory and~     atherosclerosis markers.~      We anticipate that the study will provide information on the efficacy of the Mindfulness and~     Yoga interventions as stress-reduction practices, variability in potential markers for~     activation of the brain/cardiovascular system connections, and preliminary estimates of~     effect size for each of these markers. Thus, the study will provide the data needed for~     designing a future study that will rigorously address these questions in a larger, randomized~     trial of Mindfulness and Yoga in patients with cardiovascular risk.~   "
218669|NCT00696839|"~     The hypothesis is that participants in the intervention group will experience fewer/less~     intense side effects from anti-HIV medications, if they receive training sessions on the use~     of guided imagery, relaxation, and reframing of the medication-taking experience. Such~     training is not part of the usual care of HIV patients.~   "
218670|NCT00696826|"~     A study to compare the plasma concentrations of MK0431 at different times in patients with~     hepatic insufficiency vs healthy control subjects.~   "
218671|NCT00696813|"~     The purpose of this non-interventional, observational and international registry study is to~     document the prescribing patterns in daily clinical practice and to assess long term~     treatment outcomes related to initiation of treatment with oral antipsychotics in a~     naturalistic setting.~   "
218672|NCT00696800|"~     To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa~     (Organon 36286) to induce multifollicular development for controlled ovarian stimulation~     using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single~     injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in~     initiating multifollicular growth.~   "
218673|NCT00696787|"~     The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of~     pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.~   "
218674|NCT00696774|"~     The purpose of this study is to help answer the following research question: Whether~     switching to duloxetine improves depressed mood when current treatment did not work well for~     patients with depression.~   "
218675|NCT00696761|"~     Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of~     α1-blockers for treating BPH has been well documented and they are recommended for the~     treatment of BPH by clinical guidelines.~      It is not well known if a stratification based on the grade of BOO and bladder contractility~     has any predictive value for patients who are treated with an α1-selective blocking agent. In~     our study, we investigated possible differences in treatment outcome between patients with~     and without BOO, and with or without proper contractility who are treated with alfuzosin. So~     we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH~     patients by the grade of BOO and/or bladder contractility.~   "
218676|NCT00696748|"~     The objective of the study is to assess the effect of the testosterone therapy on the body~     composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic~     syndrome and hypogonadism.~   "
218677|NCT00696735|"~     Follicular lymphomas are a subgroup of B-cell non-Hodgkin lymphomas, accounting for 15% to~     30% of newly diagnosed lymphomas.1-3 Median survival varies from 5 to 10 years depending on~     the prognostic factors at diagnosis and response to first-line therapy.4-6 Whatever the~     treatment, no plateau appears on survival curves, and virtually all patients relapse;~     follicular lymphomas are ultimately progressive, and fatal.2,3,5 No reference first-line~     treatment is clearly defined. One of the most active therapies is still doxorubicin-based~     chemotherapy with or without interferon.7-9 New therapeutic approaches including purine~     analogs and anti-CD20 monoclonal antibody are promising and are progressively included in the~     management of these lymphomas.2,3,10-13 The role of high-dose therapy (HDT) as a salvage~     treatment for patients with relapsing follicular lymphoma is demonstrated by some authors;~     several reports have shown the superiority of HDT followed by autologous stem-cell~     transplantation, purged or unpurged, compared with conventional chemotherapy in terms of no~     relapse and overall survival.14-18 Only a few reports have been published showing HDT results~     as a first-line treatment for poor-risk patients with follicular lymphoma, and the results~     remain controversial.19-26 These data prompted the French Groupe Ouest-Est des Leucémies et~     Autres Maladies du Sang (GOELAMS) to conduct a prospective randomized trial using patients~     with newly diagnosed follicular lymphoma with a high tumor burden. A combined~     doxorubicin-based chemotherapy associated with interferon was compared to front-line HDT~     followed by purged autologous stem-cell transplantation.~   "
218678|NCT00696722|"~     The purpose of this study is to determine whether atazanavir use is of influence on the~     endothelial dysfunction associated with type 2 diabetes mellitus.~   "
218679|NCT00696709|"~     The purpose of the study is to see if an investigational vaccine for shingles is safe and~     well tolerated and brings about an acceptable antibody response.~   "
218680|NCT00696696|"~     This study tests the combination of two targeted therapies,along with chemotherapy treatment~     in the treatment of pancreatic cancer.~   "
218681|NCT00696683|"~     This retrospective study was conducted to collect data from approximately 100 patients from 6~     months to 18 years of age who were stung by a scorpion but were not treated with antivenom.~     The study consisted of a review of hospital records of patients who were admitted for~     intensive care management of scorpion envenomation, at the only two hospitals in North~     America known to admit children routinely for scorpion sting management without antivenom.~     The standard of care consisted of symptomatic and supportive care, including airway~     maintenance, fluid and electrolyte support and, if necessary, sedation.~   "
218683|NCT00696644|"~     This observational study will evaluate the incidence of new vertebral and non vertebral~     fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This~     study will also evaluate BMD, compliance to treatment, back pain and the health-related~     quality of life.~   "
218684|NCT00696631|"~     The purpose of this study is to assess the efficacy, tolerability and safety of dronedarone~     versus placebo in patients with symptomatic congestive heart failure (CHF) and left~     ventricular dysfunction (LVD) when added to evidence based treatments for CHF.~   "
218685|NCT00696618|"~     This study is looking at 3 different types of enemas used before receptive anal intercourse~     in men who have sex with men (MSM). We are investigating whether the enemas cause any damage~     to the lining of the colon, how far up the colon the enemas travel after they are given, and~     how much study participants like using each of the enemas.~   "
218686|NCT00696605|"~     The are 2 principal goals in this study:~        1. To measure plasma copeptin levels in healthy subjects and to correlate them with plasma~          AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.~        2. To measure plasma copeptin concentrations in patients with chronic renal failure under~          the same conditions described above, in order to characterize the impact of renal~          function on circulating copeptin levels in correlation to plasma AVP and urine~          osmolality.~   "
218687|NCT00696592|"~     This phase II study was designed to evaluate the safety, tolerability, and efficacy of~     bevacizumab treatment in conjunction with PDT at the low fluence rate compared with~     bevacizumab alone or combined with PDT at the standard fluence rate, in patients with all~     types of choroidal neovascularization secondary to AMD.~      Hypothesis: bevacizumab in combination with PDT (low and standard fluence rate) will i) delay~     time to retreatment, ii) reduce the average number of treatments required compared to~     bevacizumab alone and iii) at low PDT fluence rate will improve long-term safety profile.~   "
218688|NCT00696579|"~     A significant number of patients with high risk superficial bladder cancer has progression to~     invasive disease. No consensus exists regarding the optimal treatment to decrease the~     recurrence and progression rate. The aim of this research is to evaluate the safety,~     tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of~     high-risk superficial bladder cancer~   "
218689|NCT00696566|"~     The principal research question is: Can platelet P2Y12 receptor blockade by the~     antithrombotic drug clopidogrel be significantly enhanced by coadministration of the~     antibiotic rifampicin?~      Clopidogrel is an antithrombotic drug in clinical use that reduces the risk of heart attack~     and coronary stent thrombosis. However some patients respond poorly to clopidogrel, at least~     partly because they fail to convert it effectively to its active form, and consequently are~     at higher risk of arterial thrombosis. Preliminary evidence indicates that the antibiotic~     rifampicin enhances the effectiveness of clopidogrel by increasing its conversion to its~     active form by the liver. We wish to study further the extent of rifampicin's effect on~     clopidogrel to see whether this might be useful in clinical practice.~   "
218690|NCT00696553|"~     To test the effects of nutrition versus nutrition with resistance exercise on muscle mass~     loss, fatigue and outcomes of concurrent chemo radiation.~   "
218691|NCT00696540|"~     We will study if small children who become ill with respiratory distress during the RSV~     epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%),~     instead of normal (0.9%) saline.~   "
218692|NCT00696527|"~     The purpose of this observational study is to describe radiological, clinical and~     histological characteristics of women with infiltrative breast cancer.~   "
218693|NCT00696514|"~     It is hypothesized that vitamin B12 and folic acid supplementation reduces the number of~     incident fractures. The proposed study, a randomized placebo-controlled intervention trial,~     compares daily supplementation with folic acid (400 mcg) and vitamin B12 (500 mcg) to a~     placebo for a period of two years or longer in 3000 men and women aged 70 years and older,~     with initial basal plasma total homocysteine (tHcy) levels >= 15 micromol/L. Fracture~     incidence and time to fracture will be assessed and used as the efficacy measure.~      Metabolic studies in a sub sample of the population will be included aiming to contribute to~     an understanding of the biological mechanisms underlying the associations found between~     markers of B-vitamin status and bone quality.~   "
218694|NCT00696501|"~     The purpose of this study is to collect data while monitoring muscles and nerves during spine~     surgery. The data being collected and analyzed will be used to learn more about how the~     body's nerves and muscles are distributed and develop a map of human muscle innervation~     patterns.~   "
218695|NCT00696488|"~     The purpose of this research study is to measure adherence to the study drug (Carac) for the~     treatment of actinic keratoses.~   "
218696|NCT00696475|"~     Hypertriglyceridemia affects 30% of the population in the US. Very high level of~     triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that~     hypertriglyceridemia is an independent risk factor for cardiovascular disease.~      Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for~     the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant~     hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential~     therapeutic agent for hypertriglyceridemia.~      Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has~     been formulated as a controlled-release tablet suitable for once per day dosing. This current~     study is designed to assess the effect of diazoxide choline on triglycerides in subjects with~     baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose~     and insulin, body weight as well as the safety and tolerability of diazoxide choline will be~     assessed.~   "
218697|NCT00696462|"~     The purpose of this study will be to assess whether forced air warming decreases the rate of~     surgical site infections following cesarean section.~   "
218698|NCT00696449|"~     The primary objective of this study is to investigate potential differences between four~     treatment intervention groups in the adherence to treatment with Differin® Gel, 0.1%.~     Differin is approved by the Food and Drug Administration (FDA) to treat acne.~   "
218699|NCT00696436|"~     The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil,~     once daily (QD), compared to placebo, valsartan and olmesartan in participants with essential~     hypertension.~   "
218700|NCT00696423|"~     This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals'~     DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to~     24 months of age, in terms of safety and immunogenicity.~   "
218701|NCT00696410|"~     Heart failure affects over 5.3 million Americans and, while other cardiovascular diseases~     have enjoyed a reduction in mortality rates over the last decade, the mortality from heart~     failure continues to rise[1]. Thus, identifying novel therapies that can reduce heart failure~     development and/or progression are warranted. Unifying to most cardiomyopathic processes is~     an impaired handling of reactive oxygen species (ROS)[2-4]. Reactive oxygen species are~     generated as byproducts of inflammation and oxidative stress that occur in the setting of~     normal myocardial aerobic metabolism. Metallothionein, glutathione reductase, and superoxide~     dismutase are major antioxidants in the myocardium that help combat oxidative stress and~     prevent myocardial damage. In certain clinical settings, including cardiac ischemia,~     diabetes, and heavy metal excess (copper, iron), myocardial oxidative stress levels are~     greatly increased. When pro-oxidant levels exceed myocardial antioxidant capabilities,~     ROS-induced membrane, protein, and DNA inactivation can lead to the development of cardiac~     dysfunction.~      One means of preventing the development or progression of cardiomyopathy is to reduce~     oxidative stress through up-regulation of intramyocardial antioxidants. Murine studies of~     cardiomyopathy have shown that oral administration of zinc acetate may succeed as an indirect~     myocardial anti-oxidant because zinc sufficiently up-regulates the intramyocardial production~     of superoxide dismutase (a zinc-dependant anti-oxidant enzyme) and metallothionein (a super~     antioxidant) [5-8]. Zinc also directly reduces prooxidant Cu levels by reducing~     gastrointestinal zinc absorption. However, to date, no studies have examined the impact of~     zinc acetate supplementation in subjects with cardiomyopathy and systolic failure on~     antioxidant capacity and remodeling.~      The hypothesis of this pilot study is that administration of oral zinc acetate to humans with~     cardiomyopathy will lead to an up-regulation of myocardial anti-oxidant capabilities,leading~     to a favorable reduction in oxidative stress. This study will provide preliminary data to~     support a randomized, placebo-controlled trial of zinc therapy in heart failure as a means of~     improving or preventing the progression of systolic dysfunction in subjects with~     mild-moderate heart failure.~   "
218702|NCT00696397|"~     The purpose of this research is to study the sleep patterns of people with moderate to severe~     atopic dermatitis and how itching affects those patterns. This study will also measure your~     body's activity during sleep using non-invasive tests described below.~   "
218703|NCT00696384|"~     The purpose of this study is to determine the long term safety and tolerability of azilsartan~     medoxomil, once daily (QD), in participants with Essential Hypertension.~   "
218704|NCT00696371|"~     This study will use positron emission tomography (PET) to measure a receptor in the brain~     that is involved in inflammation. It will test two radioactive chemicals used in the~     procedure to see if the newer chemical, [(11)C]B, is as good or better than the older one,~     [(11)C]A, for measuring brain inflammation.~      Healthy volunteers 18 years of age and older may be eligible for this study. Participants~     undergo an evaluation, [(11)C]A PET scan, [(11)C]B PET scan and magnetic resonance imaging~     (MRI), as follows:~      Evaluation~      Medical history and physical examination, blood and urine tests~      PET scans~        -  [(11)C]A scan. A catheter (plastic tube) is placed in an arm vein for injection of the~          [(11)C]A isotope. Some patients also have a catheter placed in an artery in the wrist to~          collect arterial blood samples during the scan. Subjects then lie on the scanner bed and~          a special mask is fitted to the head to help keep the subject s head still during the~          procedure. Following an 8-minute scan to calibrate the scanner, the [(11)C]A is injected~          into the catheter in the vein and pictures are taken that show where chemicals related~          to inflammation are present. The procedure takes about 2.5 hours.~        -  [(11)C]B scan. The procedure is the same as above for [(11)C]A, except the isotope used~          is [(11)C]B.~      MRI scan.~      This test uses a strong magnetic field and radio waves to obtain images of body organs and~     tissues. The subject lies on a table that can slide in and out of the scanner (a metal~     cylinder), wearing earplugs to muffle loud noises that occur during the scan.~   "
218705|NCT00696358|"~     308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in~     treating vitiligo. They have the same wavelength but the type of emission of the photons is~     different. To date there is no direct comparative data concerning these two devices in this~     indication.~      The aim of the study is to make an intra-individual prospective comparison between these two~     phototherapies.~   "
218706|NCT00696345|"~     Epigenomics is developing a colon cancer screening assay based on differential methylation of~     specific CpG sites for the detection of early stage disease. A genome-wide methylation~     analysis and oligonucleotide array study using DNA from various stages of colon cancer and~     normal tissue have been completed to obtain candidate CpG markers. Based on results obtained~     in the above studies, Epigenomics has moved to the final stages of feasibility with a~     specific, highly sensitive real-time marker assay that is able to detect colon cancer DNA in~     blood plasma.~   "
218707|NCT00696332|"~     The purpose of this study is to assess the efficacy, tolerability and safety of oral~     administration of talampanel compared to a placebo in subjects with ALS.~   "
218708|NCT00696319|"~     The study that is registered in ClinicalTrials is a part study of an overall study with the~     title 'Dynamic stability of the ACL-injured knee'. The aim of the overall study is to~     prospectively follow a cohort of newly injured patients with total rupture of the anterior~     cruciate ligament in the knee, in order to document results from different rehabilitation~     regimes after the injury.~      The title of the part study is 'Neuromuscular changes in ACL-deficient individuals before and~     after an intensive perturbation training program. A case-control study.' The aims of the part~     study are:~        1. To describe muscle activation patterns, joint angles and forces during gait and~          one-legged hop in newly injured ACL-deficient individuals before and after execution of~          an intensive training program consisting of either perturbation training or conventional~          balance- and stability training~        2. To describe eventual changes between the two groups that may indicate superiority of~          either one of the methods~      The study will include 25 subjects in each group. The intervention consists of two different~     rehabilitation protocols for neuromuscular training. Subjects will be tested in a~     biomechanical laboratory before and after intervention, with use of 3D camera systems, force~     plates and electromyographic measurements (EMG). Main outcomes are eventual differences in~     muscle activation patterns, joint angles and forces during selected phases of walking and~     one-legged hopping. Secondary outcomes of interest are self-assessment of knee function,~     isokinetic strength and functional one-legged hop tests.~      Status: Inclusion to the main study started in January 2007. Data collection for the~     case-control part study will take place in 2008-2009. The part study study should be finished~     in 2010, where results will be included in a PhD dissertation. The PhD student responsible,~     Ingrid Eitzen, is enrolled in the Doctoral program at the Faculty of Medicine, University of~     Oslo. She is employed at Orthopaedic Centre, Ullevaal University Hospital and part of The~     Norwegian Research Center for Active Rehabilitation (NAR). The project is included in the NAR~     research program. In addition, the overall study is organized as a formalized collaboration~     with the University of Delaware, US, where they also will follow a cohort of 150 subjects.~   "
218709|NCT00696306|"~     The purpose of the study is to use diffusion tensor imaging (DTI) derived axial diffusivity~     and susceptibility weighted imaging (SWI) to evaluate the severity of acute ischemic stroke~     and to predict its functional outcome.~   "
218750|NCT00695747|"~     The purpose of this study is to compare the safety & effectiveness of the two types of~     cataract and glaucoma surgeries. Results from this study may improve the surgical and post~     surgical management and long term management of patients with these conditions in the future~   "
218710|NCT00696293|"~     The following primary hypotheses will be tested:~        1. During Step 1: Major Depressive Disorder (MDD) or Chronic Low Back Pain (CLBP) in < 40%~          of the initial 60 subjects treated with duloxetine (DUL) + Clinical Management(CM)~          during the first 8 weeks will respond (response is defined as a Montgomery Asberg~          Depression Rating Scale (MADRS) score </=9 and at least a 30% improvement in back pain~          as measured with the 20-point numeric rating scale.~        2. During Step 2: More DUL+Problem Solving Therapy for Depression and Pain (PST-DP) than~          DUL+CM treated subjects will achieve response during the second 8 weeks, defined as a~          MADRS score </=9 and at least a 30% improvement in back pain as measured with the~          2-point numeric rating scale.~        3. Improvement in depression scores will be correlated with improvement in CLBP scores.~      The exploratory hypotheses to be tested are that:~      During Step 2: Compared to subjects treated with DUL+CM, subjects treated with DUL+PST-DP~     will have improved outcomes in: 1) disability, 2) sleep, 2) functioning/quality of life, 3)~     caregiver burden/depression, and 5) analgesic use.~   "
218711|NCT00696280|"~     Delayed emesis following administration of carboplatin-based chemotherapy despite prophylaxis~     with standard antiemetic prophylaxis (5-HT3 and corticosteroid) remains a clinically~     significant and distressing problem for patients with cancer. The incidence of delayed emesis~     appears to be higher in women compared to men.~   "
218712|NCT00696254|"~     The aim of this study is to investigate the effect of general anaesthetics on nerve~     excitability. We use the method of threshold tracking to measure selected parameters of nerve~     excitability.~   "
218713|NCT00696241|"~     The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil,~     once daily (QD), compared to placebo and olmesartan in participants with essential~     hypertension.~   "
218714|NCT00696228|"~     To test the effects of a modified Atkins high fat diet on endothelial function, insulin~     resistance and energy balance.~   "
218715|NCT00696215|"~     The objective of the study is to assess the effects of rasagiline on cognitive functions in~     patient with Parkinson's disease. Patients on any dopaminergic medications will be assigned~     to receive rasagiline 1 mg or placebo over 3 months. Cognitive functions will be assessed by~     selected neuropsychological tests representing each cognitive domain.~   "
218716|NCT00696202|"~     In this trial the efficacy and safety of Mirena was investigated during the first year of use~   "
218717|NCT00696189|"~     The concept of ocular perfusion pressure (OPP), is defined as the difference between the mean~     arterial pressure (MAP) and the intraocular pressure (IOP.)It has been hypothesized that~     unopposed decreases in MAP, increases in IOP or a combination of the two may result in hypo~     perfusion of the eye and can cause an ocular infarction at the level of the retina or optic~     nerve, leading to varying degrees of visual loss which is frequently bilateral and~     irreversible.~      Both the prone position and downward head tilting (Trendelenburg position) have been~     associated with increases in IOP compared to the supine horizontal position (2,4,5,6), but it~     is not known whether the Trendelenburg position during surgery and anesthesia is associated~     with POVL.~   "
218718|NCT00696176|"~     The primary goal of this study is to evaluate the safety of a transcription factor decoy~     targeting Signal Transducer and Activator of Transcription 3(STAT3) in patients with head and~     neck cancer. The rationale for targeting STAT3 using this approach is to decrease~     STAT3-mediated gene regulation. The study has the following scientific objectives:~        1. To assess the safety of a single dose of intratumoral STAT3 decoy.~        2. To estimate the effect of STAT3 decoy therapy on STAT3 activation levels, STAT3-mediated~          gene expression, and apoptosis in treated tumors.~   "
218719|NCT00696163|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart~     30) for the treatment of diabetes mellitus under normal clinical practice conditions in~     India.~   "
218720|NCT00696150|"~     Studies have suggested a link with effective pain relief and reduced illness and death in~     very unwell patients. This study will determine the most effective method of injecting local~     anaesthetic around the nerves which supply the hip joint. Local anaesthetic will be injected~     around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve~     stimulator to guide the positioning of the needle on patients due for elective total hip~     replacement. The patient will then be observed for 30 minutes and the patient ability to move~     or feel the upper leg will recorded. A standard anaesthetic and a hip replacement operation~     will then be performed. Standard pain relief protocols will be used the operation and after~     the operation. After the operation we will record the amount of morphine used and how happy~     the patients have been with their treatment at 6 hours after the operation and at 24 hours~     after the operation. The first day the patient is able to walk on their new hip replacement~     will also be recorded.~   "
218721|NCT00696137|"~     This study is designed to provide continued access to BEMA Fentanyl for those subjects who~     previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the~     treatment of their breakthrough cancer pain.~   "
218722|NCT00696124|"~     The purpose of this study is to determine the safety, tolerability and preliminary efficacy~     of intramuscular injections of VM202 for subjects with critical limb ischemia.~      Subjects selected for this study will have critical limb ischemia that has not responded to~     standard therapy with symptoms including pain at rest and/or ischemic ulcers.~   "
218723|NCT00696111|"~     The purpose of this study is to look at the metabolic (use of energy) and hormonal features~     of sleep problems in women with polycystic ovary syndrome (PCOS).~   "
218736|NCT00695942|"~     Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world.~     Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to~     VTE by biological thrombophilia and are the principal cause of perinatal mortality. the~     identification of predictive factors of risk of occurrence or recurrence of two pathologies~     could enable us to propose an appropriate monitoring of patients at risk.~   "
218737|NCT00695929|"~     Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of~     complex congenital malformations, require inotropic support for low cardiac output syndrome.~     Milrinone through its positive inotropic and vasodilatory effects is widely used for this~     purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with~     calcium-sensitizing properties. We hypothesized that using Levosimendan would result in~     reduced serum lactate through a higher cardiac index.~   "
218724|NCT00696098|"~     Short chain fatty acids (mainly butyrate, acetate, and propionate) are produced in the large~     intestine by bacterial fermentation of undigested carbohydrates, such as dietary fibres.~     Butyrate is an important energy source of the intestinal epithelium and has a pivotal role in~     the regulation of epithelial cell proliferation and differentiation, immune function and~     mucosal protection.~      Non-digestible carbohydrates (prebiotics) increase the concentrations of colonic butyrate,~     which has been proposed to be responsible for its beneficial effects. Furthermore, butyrate~     enemas have been proven to be effective in the treatment of active ulcerative colitis.~      In the present study, the direct effects of butyrate on inflammation and parameters of~     colonic defence and mucosal integrity of the distal colon will be studied in 40 patients with~     diarrhoea predominant IBS (D-IBS) and 40 patients with ulcerative colitis in remission~     (UCrem) using rectal enemas. These patients groups were chosen because they have a low-grade~     inflammation in the large intestine, and can therefore be used as a model to study the~     mechanistic effects of butyrate. The design used to study the effects of butyrate in both~     patient groups will be a double blind randomized placebo-controlled parallel design.~   "
218725|NCT00696085|"~     The goal of this study was to determine whether a series of blood markers of alcohol use~     obtained from alcohol using pregnant women could help them to change their behavior.~   "
218726|NCT00696072|"~     The purpose of this study is to find out what effect the combination of letrozole (brand~     name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to~     letrozole alone~   "
218727|NCT00696059|"~     Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis~     (RA) patients have found that erosive damage may heal in some RA patients treated with~     anti-TNF. Repeated examinations of adalimumab (Humira) treated RA patients, using computed~     tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and radiography will~     allow detailed assessment of the extent of bone repair/healing during adalimumab (Humira)~     therapy.~   "
218728|NCT00696046|"~     Compared to other stemcell sources cord blood (CB) is easier and safer to procure, has no~     donor attrition, a limitless supply, reduced viral transmission, less acute & chronic GVHD,~     is rich in hematopoietic progenitor cells, and immaturity of T-cell-mediated immunity. CB has~     delayed neutrophil and platelet engraftment, a prolonged immune reconstitution, uncertain~     graft-vs-tumor activity, and cell doses from single CB units (U) are a limiting factor for~     larger recipients Using the intravenous route (IV), a close match between the patient (pts)~     and the donor or CBU can improve a pts outcome after transplant. Even though a closely~     matched CBU is preferred, the studies suggest the match may not have to be as close as is~     needed for marrow or peripheral blood transplants If one has an uncommon tissue type, the~     doctor may not find a closely matched adult donor and a CBU may be an option, are stored and~     ready to use. GVHD is a complication after an allogeneic transplant. Studies founded that~     after a CBtransplant, fewer pts get GVHD than after marrow or peripheral blood transplants.~     Pts in the studies who did get GVHD after CBtransplant tended to get less severe cases We~     hypothesized that direct intrabone transplant of CBcells could improve haematologic recovery~     due to a better stem cell homing, based on the following observations: stem cells recirculate~     in animals irradiated with limb shielding; a limited fraction (10-15%) of cells injected iv~     to the haematopoietic sites, possibly because the large majority is lost in other organs; in~     a mousemodel, HSC directly injected ib repopulated the marrow of lethally irradiated mice~     10times more efficiently than HSC cells injected iv; delayed engraftment after CB transplant~     is possibly not caused by insufficient stem cell numbers; indeed, children grafted with CB~     cells have superior stem cell reservoir 1year posttransplant when compared to marrow~     transplant recipients Based on these data, we set-up a phase I-II study to evaluate whether~     ib injection could be safely performed and whether this procedure could ensure engraftment~     and shorten the time of complete hematopoietic recovery in adults with high risk~     haematopoietic malignancies compared to the published data. Neutrophil recovery >80% at day60~     and Platelets recovery >80% at days100 were defined as success. 1° endpoint was the~     probability of neutrophils and platelets recovery after ib CB transplant, 2° included~     incidence of acute GVHD, relapse, overall survival~   "
218729|NCT00696033|"~     Aims :~        -  exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy~          volunteers, on the neural correlates of encoding and retrieval of information during a~          word-stem completion task (implicit memory), using fMRI~        -  comparing lorazepam effects to diazepam (0.3 mg/kg)effects~        -  exploring benzodiazepines effects, after a single oral intake, on the neural correlates~          of successful encoding of information within explicit memory using fMRI~      Hypothesis :~        -  both diazepam and lorazepam will impair explicit memory performance, but lorazepam only~          will impair perceptual priming~        -  lorazepam and diazepam will modify the normal correlates of information encoding within~          explicit memory~        -  lorazepam only will alter the neural correlates of perceptual priming~   "
218730|NCT00696020|"~     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL~     administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the~     Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary~     disease (COPD).~   "
218731|NCT00696007|"~     The purpose of this study is to test the effectiveness, safety and side effects of two~     chemotherapy drugs (gemcitabine and cisplatin) when combined with surgery after chemotherapy~     for patients with upper urinary tract cancer. The hypothesis is that undergoing chemotherapy~     prior to surgery will have a beneficial effect on prognosis and may improve overall survival~     as in patients with bladder cancer, and will allow better tolerance of chemotherapy than if~     it were given after surgery.~   "
218732|NCT00695994|"~     The aims of this study are:~        1. to compare the toxicity profile and efficacy of gemcitabine/carboplatin or docetaxel in~          East Asian and Caucasian patients.~        2. to determine the genotype distribution of genes involved in docetaxel and gemcitabine~          pathways in East Asian and Caucasian patients.~        3. to evaluate the association between genotypes and~             1. treatment toxicity~             2. treatment efficacy~             3. pharmacokinetics.~   "
218733|NCT00695981|"~     This study aims at determining the effectiveness and cost-effectiveness of surgical~     management of full-thickness rotator cuff tears compared to conservative treatment. The~     research setting is prospective, randomised, and controlled.~      The aim of the study is to search out evidence based data of indications for rotator cuff~     repair. The investigators also aim at offering patients the most efficient and effective~     treatment and reduce the number of operations that do not have sufficient effectiveness. The~     data obtained will facilitate developing guidelines for referrals to a specialist when~     rotator cuff tear is suspected.~      The investigators hypothesize that there are subgroups of patients suffering from rotator~     cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.~   "
218734|NCT00695968|"~     To determine the sensitivity, specificity, and accuracy of preoperative ultrasound,~     elastography, mammography and breast MRI in women with dense breast tissue diagnosed with~     breast cancer; to test whether elastography or MRI can improve upon routine mammogram and~     conventional ultrasound in women with dense breast tissue.~   "
218738|NCT00695916|"~     To see if performing breast MRI before a lumpectomy will help the surgeon successfully remove~     the entire cancer with normal tissue margins in a single operation thereby reducing the need~     for additional surgical procedures. The study will also measure how well MRI can find~     unsuspected cancers in the same breast as the known cancer; how well MRI will find~     unsuspected cancers in the opposite breast; how often MRI will generate false positive MRI~     findings; whether routinely incorporating breast MRI delays care or adds unnecessary cost;~     and, whether breast MRI is able to reduce the frequency of cancer recurrence in the treated~     breast or elsewhere in the body.~   "
218739|NCT00695903|"~     The overall goals of this study are to compare the safety and efficacy of daptomycin~     monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels~     of 15 to 20 μg/mL for the treatment of methicillin-resistant S. aureus bacteremia (MRSA),~     including right-sided infective endocarditis (RIE).~   "
218740|NCT00695890|"~     Null hypothesis (HO): There will be no difference in pupillometry readings when using any of~     the maintenance anesthetic techniques within subjects.~      Alternate hypothesis (HA): Pupillometry readings will be affected by a change in the~     anesthetic technique~   "
218741|NCT00695877|"~     Successful control of the HIV epidemic will require a safe and effective vaccine to be~     developed. A successful vaccine will need to stimulate a widespread immune response. The~     purpose of this study is to determine the safety of and immune response to an adenovirus~     serotype HIV vaccine in HIV uninfected adults.~   "
218742|NCT00695864|"~     We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve~     withdrawal symptoms experienced while the patient is being weaned off opioid medications.~     This medication has shown anecdotal evidence of being affective for the treatment of~     withdrawal symptoms and we hope to determine whether this is affective.~   "
218743|NCT00695851|"~     The purpose of this study is to find out whether giving a drug called PCK3145 can reduce the~     level of a protein in the blood called MMP-9 as well as to find out how long the drug will~     remain in your system over time. This drug has been tested previously in prostate cancer~     patients abroad and has been shown to be safe with minimal side effects. However, we do not~     know whether changes in MMP-9 levels correlate with tumor shrinkage or symptom improvement.~     We would also like to evaluate the potential pain relief (analgesic) effect of PCK3145 at~     15mg/m² i.v. weekly for 12 weeks on patients with both symptomatic and asymptomatic castrate~     metastatic prostate cancer who are dependent on opioid analgesics. We would also like to~     monitor pain through a brief pain questionaire, and determine the impact on markers of bone~     turnover.~   "
218744|NCT00695838|"~     The purpose of this observational study is to assess the impact of abdominal fat on severity~     and frequency of GERD symptoms .~   "
218745|NCT00695825|"~     Recent population studies have shown that the glycemic index (GI) of food products is~     positively associated with the risk of developing type 2 diabetes and cardiovascular disease~     (CVD). In the pathogenesis of type 2 diabetes and CVD, inflammatory processes play a pivotal~     role. In a previous intervention study (11 weeks), however, we found no effects of lower-GI~     vs. higher-GI diets on fasting inflammatory markers in subjects with increased risk of~     developing the metabolic syndrome. People, however, spent most of their time in the~     postprandial period. Therefore, there is a need to study the postprandial effects of low-GI~     vs. high-GI diets. In addition, it needs to be emphasized the GI is derived from studies in~     lean subjects, while especially overweight and obese people suffer from metabolic aberrations~     related to the development of type 2 diabetes and CVD. AIM: To investigate in obese subjects~     the postprandial effects of a low-GI vs. high-GI food product on metabolic risk markers. A~     second research objective is to compare these effects with those in lean subjects.~   "
218746|NCT00695812|"~     Background: Autism is a complex developmental disorder involving difficulties in verbal and~     nonverbal communication, social-emotional functioning, and markedly restricted interests and~     activities. Strong evidence from research conducted with family members of children with~     autism supports the role of genetic factors in its etiology. Thus, some family members are~     characterized by the broad autism phenotype (BAP) which involves a clinical picture of milder~     but qualitatively similar difficulties.~      Working hypothesis and aims: Researchers recently initiated prospective longitudinal studies~     investigating the early developmental profiles of young siblings of children with autism~     (SIBS-A). Such longitudinal SIBS-A study is currently conducted at the Hebrew University and~     includes the oldest siblings studied to date. Our main aim is to identify siblings who~     manifest any autism or BAP characteristics.~      Methods: Two groups, SIBS-A (n = 42) and siblings of children with typical development~     (SIBS-TD, n = 62), were seen at ages 4, 14, 24, 36, 54 months and 7 years. We plan to~     continue the investigation at age 10 years, a time when school related abilities and~     social/emotional competences are more consolidated and to investigate the developmental~     trajectories of children's abilities from age 4 months to 10 years using growth curve~     analyses.~      Expected results: We expect that compared to SIBS-TD, significantly more 10-year-old SIBS-A~     will display difficulties related to ASD or BAP related difficulties. We also expect to~     identify different patterns of stability and/or change in the development of children's~     abilities from age 4 months to 10 years, between the two groups.~      Importance: This study provides a useful approach for the examination of the main research~     hypothesis regarding the development of SIBS-A. One of the main advantages of using the~     growth curve analysis is the identification of early predictive markers for future~     development.~      Probable implications to Medicine: This research has significant implication for early~     identification and the search into the causes of autism and the BAP, as well as for~     implementation of early treatment and prevention programs. By highlighting expressions of ASD~     and the BAP in siblings, we may identify early clinically predictive behavioral markers~     associated with their onset and contribute to the investigation of underlying genetics~     mechanisms.~   "
218747|NCT00695799|"~     The pollution of the operating room environment by anesthetic agents had been questioned,~     studied and documented in the past. These investigations demonstrated the existence of~     teratogenic effects in animals and the possibility of a decrease in mental performance,~     reduced fertility, fetal loss, spontaneous abortion and addictive potential in humans with~     chronic exposure to trace amounts of anesthetic agents. These findings led to the~     establishment of exposure limits and industry standards by consumer protection agencies, such~     as National Institute for Occupational Safety and Health (NIOSH). However, these standards~     applied to inhalation anesthetic agents that were excreted from the lungs of patients during~     expiration. These concerns about operating room pollution weaned away with the introduction~     of intravenous anesthetic agents, such as propofol, because it was believed propofol was~     excreted by systems other than the lungs. Recent research points to the contrary and~     demonstrates the excretion of propofol vapor in the expired gases of patients. Furthermore,~     animal experiments in our laboratory establish the existence of a biological mechanism~     responsible for addiction in animals exposed to trace amounts of propofol. We propose to~     study the exposure levels of anesthesia care providers in the operating room, during propofol~     use, under standardized conditions. Our findings will help to establish preventive measures~     for propofol addiction in anesthesia care providers.~   "
218751|NCT00695734|"~     This study aims to compare the performance of the tuberculin skin test, used for more than 50~     years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have~     recently become commercially available (Interferon-gamma release assays) in a population of~     immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis~   "
218752|NCT00695708|"~     The purpose of this study is to reveal the effects of computer-aided cognitive-auditory~     training on cerebral reorganization in schizophrenia.~   "
218753|NCT00695695|"~     This study will explore how caregivers adjust to having a child with Down syndrome.~      Primary caregivers 18 years of age and older of a child with Down syndrome may be eligible~     for this study. Participants complete a 20- to 30-minute survey that explores the subject s~     thoughts and feelings about being a caregiver to a child with Down syndrome. Questions~     explore the impact on the subject of being a caregiver for a child with Down syndrome, the~     subject s uncertainties related to the child s condition and goals for the child related to~     social skills, behavior, learning and education, physical and mental health, independence,~     and other goals. It also asks questions about the caregiver, the family and the child with~     Down syndrome.~   "
218754|NCT00695682|"~     Injections of medicine into the middle of the eye (intravitreal injections) are commonly used~     in a multitude of retinal diseases. We are looking for new treatments that may be beneficial~     in treating retinal disease and improving patients' vision.~      Infliximab (Remicade) is a genetically engineered antibody against a molecule in the body~     called TNF-α. It neutralizes the effects of TNF-α by binding to it. Intravenous Infliximab~     has been used for inflammatory arthritic conditions and Crohn's disease since 1998. We do not~     know if infliximab injections into the eye are safe. We are performing this pilot study to~     determine if they can be safe.~   "
218755|NCT00695669|"~     The purpose of the study is to characterize the immunogenicity & safety of 2 doses of GSK's~     avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64~     years~   "
218756|NCT00695656|"~     To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics,~     health care management) of hypertensive patients seen in general practitioner consultation.~   "
218757|NCT00695643|"~     The purpose of the study is to determine whether mesalazine granules compared to placebo is~     effective in prevention of recurrence of disease.~   "
218758|NCT00695630|"~     An increase in the utilization of anesthesia and sedation medications by~     non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in~     part, by the need for pharmacological tools to address high levels of fear and anxiety about~     dental care among the US population and the evidence of oral health disparities among those~     who are fearful . Given the prevalence of dental fear in the general population and in the~     various populations with the greatest burden of oral diseases, effective sedation techniques~     are needed that are safe and effective in the hands of general dentists that make up the~     front line in the efforts to reduce oral health disparities. This study is to determine~     whether, when compared to a saline placebo, a single intraoral submucosal administration of~     the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or~     less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual~     dosing of triazolam (3 doses of 0.25 mg over 90 minutes).~   "
218759|NCT00695617|"~     The optimal anticoagulation procedure during MARS treatment has not been defined. In various~     multi-centre trials, such as MARS-RELIEF, anticoagulation procedures are left to the~     discretion of the treating physician. On the one hand, given the increased risk of bleeding~     associated with liver failure, high dosage of anticoagulation therapy should be avoided. On~     the other hand, contact of blood or blood components with the extracorporeal circuit will~     likely result in coagulation activation or even loss of coagulation factors.~      Citrate anticoagulation has gained popularity, especially in hemodialysis patients. It~     results in a highly effective anticoagulation, exclusively confined to the extracorporeal~     circulation. Moreover, dependent on the type of dialyser membrane, citrate anticoagulation~     resulted in reduced activation of other cellular components.~      In contrast to hemodialysis patients, experience with citrate anticoagulation during~     treatment with artificial liver devices is limited. The liver contributes substantially to~     the metabolism of exogenous citrate. As a result, cirrhotic patients have decreased~     endogenous citrate clearances. Importantly, blood purification devices contribute~     substantially to overall citrate clearance, thereby preventing accumulation of citrate.~     Several centres, including our own, have gained experience with citrate anticoagulation~     during fractionated plasma separation and adsorption (FPSA), a related liver dialysis device,~     in the treatment of liver failure patients.~      Citrate anticoagulation during MARS treatment has not been studied so far.~   "
218760|NCT00695604|"~     The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids~     (ICS) vs. placebo in adults with chronic stable asthma.~   "
218761|NCT00695591|"~     Lay Summary Patients with severe neuromuscular develop hypoventilation, which leads to~     elevated carbon dioxide levels. Measuring only oxygen saturation levels with pulse oximetry~     may be inadequate. End tidal carbon dioxide levels or arterial blood gases should be measured~     periodically, depending on the clinical condition of the patient. A thorough review of~     systems will help define any problems. Patients who are hypoventilating often have elevated~     carbon dioxide levels at night and complain of a morning headache, restlessness or~     nightmares, and poor quality sleep. This may cause daytime sleepiness. Insufficient~     respiration with hypoxia may occur later, especially if the lung is damaged by chronic~     aspiration.~      We propose to evaluate the use of the Nonin LifeSense monitor in home evaluation of~     respiration, oxygen level, heart rate, and carbon dioxide level and to develop interpretation~     of the results that will lead to appropriate interventions for apnea, and insufficient~     respiration.~      Relevance to MDA Fewer than one per cent of the Muscular Dystrophy Association have~     pulmonologists as co-directors.Late referral of progressive restrictive lung disease leads to~     invasive support of respiratory failure. Early initiation of non invasive ventilation~     techniques requires patience on the part of the caregiver and exploration of mask interfaces~     and ventilation techniques. In addition, the development of new therapies, currently~     manifested through enhanced diagnostic accuracy, will require new signal for initiation and~     in the assessment of success or failure.~      Aims Aim 1. To assess the utility of a small portable device (LifeSense Monitor Nonin Medical~     Inc. Plymouth Minnesota) with extended recording capabilty to provide accurate diagnosis of~     hypoventilation.~      Aim 2. To provide an easily interpretable report defining sleep hypoxemia, hypercapnea, and~     apnea.~      Aim 3. To promote early evaluation and treatment of the respiratory problems in centers that~     do not have pumonologists as these are essential to prognosis, whether of survival or of~     quality of life, in neuromuscular diseases.~   "
218762|NCT00695578|"~     The purpose of this research study is to evaluate the use of Biafine Cream on wounds created~     by removal of actinic keratosis using cryotherapy in a clinical setting.~   "
218763|NCT00695565|"~     The purpose of this study is to determine whether ARC-4558 is effective in managing pain~     associated with painful diabetic neuropathy.~   "
218764|NCT00695552|"~     This trial investigates the biological effect of exercise training on depression.~     Participants will randomly be allocated to either a aerobic exercise group performing~     exercise on stationary bikes or a group performing low-impact exercise such as stretching~     exercises. Both groups will attend sessions three times per week for 3 months. Before and~     after the intervention the investigators will measure the severity of depression using the~     Hamilton depression rating scale (HAM-D17).~   "
218765|NCT00695539|"~     This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate~     the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in~     approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.~   "
218766|NCT00695526|"~     Cranberry, containing flavonoids, is effective on improvement of lipid profiles in~     non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid~     profiles in type 2 diabetic patients using oral antidiabetic drugs.~   "
218767|NCT00695513|"~     An important group of protein-bound uremic retention solutes originate from protein~     fermentation in the colon. P-cresol is a putrefaction metabolite of tyrosine. Indole is~     generated by fermentation of tryptophan. After absorption, the majority of p-cresol and~     indole are further metabolised and conjugated to form p-cresylsulphate and indoxyl sulphate.~     There is clear evidence, both in vitro and in vivo, that accumulation of these conjugated~     fermentation metabolites in kidney disease is correlated with clinical (cardiovascular)~     endpoints.~      Bacterial protein fermentation can be influenced by altering the colonic microenvironment,~     influencing the ratio of available carbohydrates to nitrogen, by shortening the colonic~     transit time or a combination of these. From a theoretical point of view, functional foods,~     i.e. pro-, pre- and synbiotics, fulfil these criteria.~      Prebiotics have been defined as non-digestible food ingredients that beneficially affect the~     host by selectively stimulating growth, and/or activity, of one or a restricted number of~     bacteria in the colon. Dietary fibre may suppress the generation of bacterial protein~     fermentation either by altering the colonic microenvironment or by shortening the colonic~     transit time. Animal and clinical studies evaluating the effect of dietary fibre supplements~     on the generation of bacterial fermentation metabolites have provided conflicting results.~     These discrepancies may be related to specific properties of the dietary fibre investigated.~     Dietary fibre may impair protein assimilation and the fermentability may vary to a~     substantial extent.~      Inulin and oligofructose have attracted much attention recently as nonabsorbable~     carbohydrates with prebiotic properties. When inulin and oligofructose were added to a~     controlled diet, significant increases were noted in colonic bifidobacterial populations, and~     it has been proposed that these changes promote both colonic and systemic health through~     modification of the intestinal microflora. Inulin and oligofructose are rapidly and~     completely fermented by the colonic microflora with the production of acetate and other~     short-chain fatty acids. In healthy individuals, supplementation with a mixture of inulin and~     oligofructose was shown to lower p-cresol generation. Although data in healthy volunteers are~     promising, no data are available in hemodialysis patients.~   "
218768|NCT00695500|"~     This study will determine whether varenicline, a drug that acts on the brain's nicotine~     receptors and is used to help smokers stop smoking, will have an impact on alcohol~     self-administration.~      People between 24 and 60 years of age who regularly consume alcoholic drinks (more than 15~     drinks per week for women, and more than 20 drinks per week for men) may be eligible for this~     study. The study requires five outpatient visits and one overnight hospital admission at the~     NIH Clinical Center.~      Participants undergo the following procedures:~      Visit 1 (outpatient: 4-5 hours)~        -  Standard assessments, including vital signs measurements, breathalyzer test, blood and~          urine tests (including pregnancy test for females), questionnaires about mood, symptoms,~          alcohol use and smoking, if applicable~        -  Questionnaires about medical and psychological status~        -  Health assessment and assessment of alcohol drinking behavior~      Visit 2 (outpatient: 8 hours)~        -  Standard assessments (see above)~        -  Computer-Assisted Self-infusion of Ethanol (CASE) session: Subjects will receive a~          priming intravenous infusion of alcohol. After 25 min, they will be allowed to give~          themselves additional exposures of alcohol over a period of 2 hours by pressing a button~          on a computer that controls the infusion pump.~      Visit 3 (outpatient: 2 hours)~      -Standard assessments~      Visit 4 (outpatient: 8 hours)~        -  Standard assessments~        -  Brain functional magnetic resonance imaging scan (MRI). This test uses a magnetic field~          and radio waves to produce images of the brain. The patient lies on a table that can~          slide in and out of the scanner, wearing earplugs to muffle loud sounds that occur~          during the scanning process. Initial pictures are taken of the brain's structure and~          additional scans measure brain activity while the subject performs simple tasks.~        -  Alcohol Infusion. Subjects receive an intravenous infusion of alcohol while in the MRI~          scanner to measure the brain s response to alcohol.~      Visit 5 (overnight)~        -  Standard assessments~        -  Repeat CASE session~        -  Interview about the subject's experiences participating in the protocol, including any~          symptoms and urges to drink~      Visit 6 (outpatient)~        -  Standard assessments (without blood tests)~        -  Interview about participation in the study~      Telephone follow-up~      After 3 weeks, subjects are called to check on their symptoms and gather information on their~     drinking and, if applicable, smoking.~   "
218769|NCT00695487|"~     The investigators evaluate if intravenously applied THC (Cannabis) reduces postoperative~     Nausea and vomiting. THC will be given during anesthesia before emergence. We measure how~     long and how effective it reduces PONV~   "
218770|NCT00695474|"~     The purpose of the study is to describe vitamin D status among patients with type 2 diabetes~     and to determine the association between serum 25-hydroxyvitamin D and glycemic control,~     markers of inflammation and blood pressure~   "
218771|NCT00695461|"~     Intestinal pathogenes are often involved in postoperative complications after colon surgery.~     Probiotic bacteria, i e live bacteria which have beneficial effects on the host when~     ingested, have been shown to reduce bacterial translocation in animal studies. However, in~     humans studies results have varied. The purpose with this study was to find whether high~     doses of Lactobacillus plantarum 299v affects the potentially pathogenic microflora of the~     gut, bacterial translocation and cell proliferation in patients undergoing planned colon~     surgery.~   "
218772|NCT00695448|"~     This is an open-label, multi-center Phase I study conducted to define the recommended Phase 2~     dose, toxicity profile, pharmacokinetics and biologically active dose range of GSK1059615.~   "
218773|NCT00695435|"~     To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension,~     Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic~     Solution in normal volunteers.~   "
218774|NCT00695422|"~     RATIONALE: Diagnostic procedures, such as anal swab collection, digital rectal examination,~     and anal endoscopy and biopsy, may help find and diagnose anal and genital human~     papillomavirus infection and squamous intraepithelial lesions and help doctors plan better~     treatment.~      PURPOSE: This clinical trial is studying ways to detect anal and genital human papillomavirus~     infection and squamous intraepithelial lesions in HIV-positive patients enrolled in an AIDS~     cancer clinical trial.~   "
218775|NCT00695409|"~     This phase II clinical trial studies how well yttrium Y 90 ibritumomab tiuxetan, rituximab,~     and high-dose chemotherapy followed by peripheral blood stem cell transplant in treating~     patients with relapsed B-cell non-Hodgkin lymphoma. Monoclonal antibodies, such as yttrium Y~     90 ibritumomab tiuxetan and rituximab, can block cancer growth in different ways. Some block~     the ability of cancer cells to grow and spread. Others find cancer cells and help kill them~     or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies can find tumor~     cells and carry tumor-killing substances to them without harming normal cells. Giving~     monoclonal antibody therapy, radioimmunotherapy (RIT), and high-dose combination chemotherapy~     before a peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin~     lymphoma.~   "
219061|NCT00691639|"~     The objective of this study is to obtain blood samples from patients who are or were~     participants in any Alcon AL-3789 clinical trial. Association will be conducted to search for~     genetic markers in patients with glaucoma or ocular hypertension.~   "
218776|NCT00695396|"~     The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood~     cell transfusions in anemic patients with myelodysplastic syndromes (MDS). Myelodysplastic~     syndromes are a group of disorders characterized by progressive bone marrow failure and an~     increased risk of development of leukemia.~   "
218777|NCT00695383|"~     This randomized controlled trial was designed to investigate whether a daily training session~     using a bedside cycle ergometer, started early in stable critically ill patients with an~     expected prolonged ICU stay, could induce a beneficial effect on exercise performance,~     quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard~     physiotherapy program.~   "
218778|NCT00695370|"~     Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state provides an efficient~     stem cell mobilization in children with malignancies~      Design: phase 2 study.~      Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a~     standard apheresis (less than 2 blood volume processed)~   "
218779|NCT00695357|"~     Cross-sectional, one visit study. All the data will be collected through questionnaires.~     Descriptives statistics will be applied to the data. 832 patients will participate to the~     study and 104 physicians.~   "
218780|NCT00695344|"~     The purpose of this study is to evaluate if there is a significantly less incidence of major~     clinical events due to graft vascular illness in recipients of a cardiac transplant on~     treatment with an immunosuppressive combination, which includes Everolimus, compared to those~     that continue the previously used immunosuppressive treatment.~   "
218781|NCT00695331|"~     The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol~     solution with intravenous oxytocin for labor augmentation in women without adequate uterine~     contractions.~   "
218782|NCT00695318|"~     This study will compare the safety and efficacy of Medidur FA treatment in one eye to the~     sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.~   "
218783|NCT00695305|"~     A study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs.~     placebo over 12 weeks of dosing.~   "
218784|NCT00695292|"~     This proposed Phase II trial will investigate the combination of irinotecan and carboplatin~     followed by sunitinib in the first-line treatment of patients with extensive-stage SCLC.~   "
218785|NCT00695279|"~     This protocol (GENEFU) provides a mechanism for the 15-year followup period that the FDA~     requires for all participants in gene transfer protocols and assures that adequate followup~     can be maintained for a wide variety of participants on different individual gene therapy~     protocols at St. Jude Children's Research Hospital.~      GENEFU serves as an umbrella protocol for long-term follow-up (LTFU) for recipients of gene~     therapy/gene marked (GT/GM) products at St. Jude Children's Research Hospital. The FDA has~     recommended methods to assess the risk of delayed adverse events after GT/GM and has provided~     specific requirements regarding the duration and design of LTFU observations. This protocol~     is intended to provide LTFU in accordance with the FDA guidelines for those who received a~     GT/GM product as part of a St. Jude-sponsored clinical trial or compassionate use treatment~     plan. The protocol calls for a physical examination or general health evaluation and~     collection of required blood samples annually for up to 15 years after the last receipt of a~     GT/GM product.~      Goals will be to obtain clinical histories in order to detect late clinical outcomes~     suggestive of retroviral or lentiviral disease, including but not limited to cancer/second~     malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders. Blood~     samples will be archived and tested when clinically or scientifically indicated, as in the~     event of development of a second malignancy. This prospective cohort study will utilize~     descriptive statistics in the analysis of long-term late effects outcomes. It offers a~     uniform approach to long-term safety monitoring in research participants who have received a~     gene-transduced product as part of St. Jude-sponsored GT or GM protocols and compassionate~     use treatment plans.~   "
218786|NCT00695266|"~     To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics,~     health care management) of hypertensive patients seen in hospital out patient's department by~     a cardiologist or a nephrologists.~   "
218787|NCT00695253|"~     The purpose of this study is to evaluate the safety and effectiveness of the Talent~     Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic~     aneurysms (AAA). The treatment population will include patients with an abdominal aortic~     aneurysm who meet the inclusion/exclusion criteria. All patients in the treatment population~     will undergo post-procedure follow-up evaluations at one (1), six (6), and 12 months and~     annually thereafter up to five (5) years post-procedure.~   "
218788|NCT00695240|"~     This prospective randomized controlled study will determine the efficacy of continuous local~     anesthesia at decreasing pain scores compared to patient controlled analgesia for pelvic~     organ prolapse procedures including posterior colporrhaphy and sacrospinous ligament~     fixation.~   "
218789|NCT00695227|"~     The purpose of this project is to develop an accurate method to identify patients that suffer~     from acid reflux, but may not present with classic reflux symptoms (such as heart burn).~     Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber~     Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients~     with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR.~     Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed~     up through the esophagus and may affect the vocal cords and upper respiratory tract.~      It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus~     similar to that found in a population with typical reflux symptoms. We propose to~     systematically test this hypothesis using the USE.~      This project is designed to improve the methods of identifying patients with a form of acid~     reflux that is often undetected, and thus untreated. If this project is successful then more~     patients with Barrett's esophagus will be identified; furthermore, screening and treatment~     for this pre-cancerous condition will be improved.~   "
218799|NCT00695097|"~     The aim of the study is to find out if Rituximab, which is an antibody against specific white~     cells involved in rejection, when combined with standard anti-rejection treatment can more~     effectively reverse the rejection process.~      Our hypothesis is that with acute rejection there is activation of B cells and the subsequent~     development of anti-donor antibodies that ultimately lead to graft loss. More effective~     therapy targeted at B cells may abort the development of anti-HLA antibodies, prevent renal~     injury and have a favorable effect on long-term graft outcome.~   "
218790|NCT00695214|"~     Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate~     the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study~     has investigated the reliability of this technique, demonstrating moderate-substantial~     interrater and test-retest reliability. This research has also compared DISE findings to~     those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not~     responded to previous sleep apnea surgery. These papers have been published and available~     through PubMed. Additional research is ongoing, with examination of DISE findings, comparison~     to other evaluation techniques, and the association between DISE findings and surgical~     outcomes.~   "
218791|NCT00695201|"~     The purpose of this study is to see how well patients tolerate the side effects of treatment~     with Floxuridine, Oxaliplatin and Irinotecan. We also want to know if these methods used~     together are a useful way of treating cancer. We have studied these drugs and know the best~     doses of each when they are used alone. We do not yet know how well the drugs work with each~     other. This study will tell us the best doses of each drug when they are given over the same~     period of time.~   "
218792|NCT00695188|"~     The primary objective is to determine whether erythrocyte polyglutamate levels are associated~     with objective clinical response in patients with rheumatoid arthritis after oral~     administration of low-dose methotrexate.The secondary aim of this study is to compare the~     efficacy and safety of standard dose methotrexate versus a higher starting dose.~   "
218793|NCT00695175|"~     To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics,~     health care management) of hypertensive patients seen in private cardiology consultation by~     holding account of type of exercise of the cardiologist (private exclusive or mixed hospital~     and private).~   "
218794|NCT00695162|"~     Study Objectives:~        -  1. To examine the extent to which noise typical of nursing units reduces speech~          intelligibility in acutely ill hospitalized patients~        -  2. To examine the extent to which noise typical of nursing units impairs recall in~          acutely ill hospitalized patients~        -  3. To quantify severity of reduced performance associated with age, familiarity with the~          healthcare setting, hearing and health status.~      Plan:~      One hundred and twenty inpatients from the four medical/surgical nursing units at the~     Portland VA Medical Center, 60 with normal hearing and 60 with hearing impairment will be~     recruited to participate in the study. Following assessment to ascertain eligibility and~     obtaining informed consent, patients will be tested in a sound booth housed at the National~     Center for Rehabilitative Auditory Research (NCRAR). Designed so that each patient serves as~     his or her own control, we can accommodate considerable baseline variability between patients~     without adversely affecting required sample size. Patients' performance in speech~     intelligibility and recall tests will be measured using a constant level of speech, in~     controlled environments of no noise (baseline), white noise, hospital noise and hospital~     noise with speech, all delivered via headphones in pseudo-random order. Performance will be~     measured in each type of noise at decibel levels equivalent to those currently experienced on~     nursing units and at lower levels that prior studies have shown are more conducive to~     effective communication~      By selecting measures that are particularly relevant to the safe care of hospitalized~     patients, and that have been studied extensively in healthy populations in highly controlled~     conditions, we expect to find compelling and unambiguous evidence that hospitalized patients~     correctly hear and recall very little of what is said to them during their hospitalizations.~     The majority of hospitalized patients stay on acute care nursing units during most or all of~     their hospitalizations, making this an appropriate population to study in the context of~     their responses to the noises typical in these environments. Perhaps most importantly, this~     study will heighten awareness of health-care personnel to the levels of impairment suffered~     by their patients - both in their ability to correctly interpret speech and to recall it - in~     the typical noisy environments of nursing units.~   "
218795|NCT00695149|"~     This clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow~     stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the~     lumbar puncture, and assess the safety and efficacy of the procedure.~   "
218796|NCT00695136|"~     This study will test whether donepezil (Aricept(Registered Trademark)), a drug that is~     approved by the Food and Drug Administration to treat Alzheimer's disease, can increase rapid~     eye movement (REM) sleep in children with autism and autism spectrum disorder (ASD). Some~     children with autism and ASD spend very little time in REM sleep. In some studies, decreased~     REM sleep has been associated with learning and behavior problems. Donepezil can increase REM~     sleep in some adults with different disorders. If it can increase REM sleep in children in~     this study, it might be able to be used in future studies to see if it can help learning and~     behavior problems in children with autism and ASD.~      Children between 2 and 10 years of age with autism or an ASD whose percentage of REM sleep~     time is well below the average for children of the same age may be eligible for this study.~     Candidates are screened with a medical history, physical and neurological examinations, blood~     tests, electroencephalogram (EEG) and a sleep study. The sleep study requires an overnight~     stay at the NIH Clinical Center in which the child is monitored with electrodes for EEG and~     heartbeat recording, a tube taped below the nose to measure airflow, a probe on a finger to~     record oxygen levels and a small watch-like machine on the wrist to record movements.~      Participating children may be required to have up to six overnight stays for sleep studies at~     the Clinical Center. The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Then~     they are admitted to the NIH Clinical Center for a sleep study, blood tests and EKG. Those~     whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks,~     after which they are admitted to the Clinical Center for a final physical examination, blood~     draw and sleep study. That ends their participation in the study.~      Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a~     higher dose (2.5 mg) for 2 to 4 weeks, and the above procedure is repeated. Those whose REM~     sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4~     weeks, and the above procedure is repeated once more. Children whose REM sleep does not~     increase to normal on 5 mg of donepezil stop the medication and end their participation in~     the study.~      At each study visit, study researchers talk to the parents and examine the children to~     determine if donepezil is affecting the child's behavior and if the child is hav...~   "
218797|NCT00695123|"~     This study will determine eligibility for participation in research studies on blood~     disorders conducted by the National Heart, Lung and Blood Institute and the National~     Institute of Diabetes, Digestive, and Kidney Diseases.~      Healthy volunteers, patients with blood disorders under study by NHLBI and NIDDK and~     potential stem cell donors for patients with blood disorders who are 8 years of age and older~     may be eligible for this screening protocol. (Healthy volunteers who qualify for research~     protocols would serve as control subjects.)~      Participants undergo the following tests and procedures:~      Healthy Volunteers~        -  Medical history, physical examination, blood tests and urine sample collection.~        -  Buccal mucosa sample collection. (Cells are collected from the inside of the cheek by~          gentle scraping with a bristly brush.)~        -  Bone marrow aspiration (only for volunteers 18 years of age and older).~      Potential Stem Cell Donor~      -Same as for healthy volunteers plus evaluations that may include electrocardiogram,~     echocardiogram, imaging studies (X-rays, CT scans, MRI scans and others), heart evaluation,~     and lung function tests.~      Patient with Blood Disorder~      -Same as for stem cell donors plus additional evaluations and treatments that may include~     radiation oncology evaluation, catheter placement, blood transfusions, kidney and liver~     biopsies. Short courses of drug treatment for induction of fetal hemoglobin in sickle cell~     patients, and/or iron chelation in patients receiving chronic red cell transfusions may be~     included as well.~   "
218798|NCT00695110|"~     The purpose of this pharmacokinetic study is to determine whether oral testosterone ester~     formulations can be used effectively to treat men with low testosterone.~   "
218800|NCT00695084|"~     This trial will evaluate whether progressive multiple sclerosis associated with hemiparesis~     may benefit from Constraint-Induced Movement Therapy.~   "
218801|NCT00695071|"~     The objective of this clinical trial is to document the steady state pharmacokinetics and~     safety of a new itraconazole 200 mg film coated tablet.~   "
218802|NCT00695058|"~     During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in~     pressure was observed in the external urethral sphincter along with an increase in bladder~     capacity. In a subsequent study it was demonstrated that TMNS in women could induce pressure~     increment of the external urethral sphincter. A pilot study have since shown that after 6~     weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able~     to contract their pelvic floor muscles and had become free of symptoms. Another pilot study~     has shown promising effect on the overactive bladder syndrome.~      The present study aims to treat urinary incontinence and includes 3 groups of patients with~     40 patients in each group: Women suffering from urinary stress incontinence, women suffering~     from urge incontinence and men suffering from urinary incontinence after a prostatectomy. A~     medical vibrator is used and in each group the subjects will be randomized to active~     treatment or placebo treatment.~      In women the stimulation will be performed at the perineum every day for 6 weeks with an~     amplitude of 2 mm and a frequency of 100 Hz. In men the vibration parameter/location will be~     determined by the results of a pressure profile study also included. Results will be~     evaluated on the basis of questionnaires, micturition diaries and diaper tests.~      If we are able to demonstrate a significant reduction in the incontinence symptoms in the~     subjects we asses that vibration can be a way of reestablishing a normal function of the~     pelvic floor muscles and bladder function in incontinent patients.~   "
218803|NCT00695045|"~     This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain~     relief and side effect profiles of same in the setting of Total Knee Replacement.We~     hypothesized that a dose greater than that used in Total Hip Replacement was needed and~     wished to find a dose which was effective but had a low side effect profile.~   "
218804|NCT00695032|"~     RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is evaluating kidney damage in patients receiving cisplatin and~     ifosfamide for solid tumors.~   "
218805|NCT00695019|"~     The purpose of this study is to determine whether lozenges of interferon-alpha that are~     dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who~     had a complete virologic response after receiving a combination of injected interferon-alpha~     and oral ribavirin.~   "
218806|NCT00695006|"~     To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR)~     remain elusive. The purpose of this study was to compare the effects of manual therapy,~     exercise, and cervical traction to manual therapy, exercise, and sham traction on pain,~     function and disability in patients with CR.~   "
218807|NCT00694993|"~     This is a double-blind, placebo-controlled, randomized single dose escalation study and a~     double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose~     study to investigate safety, tolerability and pharmacokinetics of an intranasal H1/H3 dual~     antagonist compound in healthy male subjects.~   "
218808|NCT00694980|"~     This is a randomized , double-blind, placebo-controlled study of approximately 70 patients~     with ulcerative colitis.~   "
218809|NCT00694967|"~     We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P)~     will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared~     to cerclage therapy. The purpose of this study was to compare medical therapy with 17P to~     surgical therapy with transvaginal cerclage in patients with an ultrasound diagnosed short~     cervix and funnel in the mid-trimester.~   "
218810|NCT00694954|"~     The role of capsule endoscopy (CE) in patients with obscure / occult gastrointestinal (GI)~     bleeding remains unclear. This pragmatic randomized controlled trial is designed to determine~     the diagnostic yield and clinical outcomes of patients with obscure GI bleeding who receive~     CE compared to those who receive usual standard care.~   "
218811|NCT00694941|"~     The objective of this study is to investigate the long term safety of ALS patients taking~     ONO-2506PO.~   "
218812|NCT00694928|"~     This study will evaluate the efficacy and safety of a vaginal product compared with that of~     another vaginal product in the treatment of vaginal infections.~   "
218813|NCT00694915|"~     The purpose of this study is to determine and compare the effect of this treatment on~     recurrence rate and to assess the toxicity in both arms of patients with STCC. Other~     objectives include determining the effects of this treatment on quality of life, and~     comparing the effect of Mycobacterium w on time to tumor progression.~   "
218814|NCT00694902|"~     This study is the first administration of GSK610677 to man. The main aim of this clinical~     study is to investigate the safety and tolerability of different doses of the investigational~     medicinal product GSK610677. 2 cohorts of 8 subjects (Cohorts I and II) will be enrolled into~     this study. Individual subjects in each cohort will have up to 3 treatment periods. In each~     treatment period, subjects will receive a single inhaled dose of GSK610677 or placebo.~     Predicted doses are: 10, 30, 50 100 250 and 500ug.For individual subjects in each cohort,~     there will be a minimum wash out period of at least 10 days. In this period safety and~     tolerability data will be collected prior to dose to the next level.After safety review~     meetings between the site and the sponsor following the administration of the 500 ug dose, it~     was decided to add an extra cohort (Cohort III) of 8 subjects and administer 1000µg. Each~     subject in Cohort III will undergo a screening visit, one treatment period, and a follow up~     visit.~   "
218815|NCT00694889|"~     The aim of this study is to investigate the efficacy of neuroscience-guided computerized~     cognitive training exercises on the remediation of cognitive deficits and symptoms associated~     with recent-onset schizophrenia and to examine the influence of subject characteristics,~     brain structure and function, and pharmacotherapy on the response to remediation.~   "
218816|NCT00694876|"~     The purpose of this study is to determine how health literacy impacts glaucoma patient~     adherence (as measured by following up with the doctor) in Tamil Nadu, India. We hypothesize~     that individuals with better health literacy will have higher rates of follow-up with their~     ophthalmologist.~   "
218817|NCT00694863|"~     The purpose of this study is to determine whether treatment with long-acting synthetic~     adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous~     nephropathy and high for renal failure.~   "
218818|NCT00694850|"~     The purpose of this study is to assess multiple ascending doses of a new drug (BAY63-2521)~     given orally, to evaluate if it is safe and can help to improve the well-being, symptoms~     (e.g. disturbed breathing) and outcome of pulmonary hypertension associated with lung~     fibrosis. Patients living with pulmonary hypertension associated with interstitial lung~     disease have a risk of increased number of hospitalisations because of worsening of their~     condition. Until now there is no approved medication for this disease. The current treatment~     of pulmonary hypertension associated with interstitial lung disease consists: of oxygen and~     medical treatment with vasodilators, e.g. so-called Calcium-antagonists. Therefore, there is~     a need for new drugs in the treatment of pulmonary hypertension associated with interstitial~     lung disease.~   "
218819|NCT00694837|"~     The objectives of the trial are:~      To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant~     to chemoradiotherapy with temozolomide in patients with a newly diagnosed glioblastoma~     multiforme.~      To describe the possible effect of nelfinavir on functional imaging To describe the activity~     of nelfinavir in vivo on blocking the AKT pathway.~   "
218820|NCT00694824|"~     A not randomized , cross sectional study will be done to determine the possible association~     of coronary artery calcification (CAC) score assessed by multirow spiral computed tomography~     (MSCT) with specific and non specific uremic factor of vascular calcification.~   "
218821|NCT00694811|"~     The primary objective of the study is to test the hypothesis that prolonged re-feeding after~     VLED induced weight loss improves weight maintenance and eating behaviour~   "
218822|NCT00694798|"~     The primary purpose of this study is to evaluate the response rate of this treatment (Mw) in~     patients with BCG refractory superficial transitional cell carcinoma. Other objectives~     include detecting the effect of Mw on Time to Tumor progression and evaluating safety.~   "
218823|NCT00694785|"~     To evaluate the effect of ARC1779, a therapeutic oligonucleotide (aptamer) in patients with~     Type2B von Willebrand Disease.~   "
218824|NCT00694772|"~     Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most~     frequently performed surgical procedures in North America. The two most prevalent indications~     for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep~     apnea (OSA). OSA is a common childhood condition that is characterized by upper airway~     obstruction, disturbed sleep and disrupted normal respiratory gas exchange. In the majority~     of children with OSA, overgrowth of the adenoid and tonsils is the primary underlying~     aetiology, making tissue removal via AT the standard of care. The purpose of this study is to~     evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy~     and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (OSA) in children.~   "
218825|NCT00694759|"~     The purpose of this study is to determine if insulin resistance (how well the body uses~     insulin and clears sugar) can affect cortisol levels in normal healthy women and women with~     polycystic ovary syndrome of all body weights.~   "
218826|NCT00694746|"~     This trial will provide preliminary data to test the hypothesis that a six-month treatment~     period with fish oil for overweight adolescent with mild to moderate persistent elevation of~     ALT levels and presence of hepatic steatosis on CT-scan is safe and will result in decreased~     ALT.~   "
218827|NCT00694733|"~     The purpose of this study is to determine if estrogen or testosterone can affect cortisol~     levels and where fat builds up in our bodies.~   "
218828|NCT00694720|"~     The primary objective of this study is to assess the activity on breathing parameters of 4~     escalating doses of AVE0657 in comparison to placebo in patients with Cheynes-Stokes~     Breathing Syndrome.~   "
218829|NCT00694707|"~     This is an study to evaluate the safety, efficacy, and tolerability of RGH-188 relative to~     placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.~   "
218830|NCT00694694|"~     This trial sets out to determine whether the combination of azithromycin and artesunate~     (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania,~     artemether-lumefantrine (AL). There are two reasons this is important~        1. there are only a limited range of drug combinations which work against malaria in this~          area of Tanzania~        2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if~          the combination is an effective antimalarial it might have a place where there are no~          diagnostic facilities as syndromic treatment for fever.~      Artesunate and azithromycin have both been used alone or in combination with other drugs in~     children in Tanzania for many years, and are considered safe. There is trial evidence for the~     effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory)~     evidence that it works against the malaria parasite.~      The trial randomizes children with non-severe malaria to the new combination AZ+AS or the~     standard care arm AL. The primary outcome is the parasitological failure rate by day 28-~     meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary~     outcomes include safety.~   "
218831|NCT00694681|"~     Working toward Wellness is a telephone care management and outreach monitoring program~     designed to help Medicaid recipients who are experiencing major depression to enter and~     remain in evidence-based treatment. To study the effects of Working toward Wellness,~     individuals receiving Medicaid in Rhode Island who are eligible for mental health services~     through United Behavioral Health were screened by telephone for depression. Those who were~     found to have major depression and who agreed to be in the study were randomly assigned.~     Program participants received intensive monitoring from Master's level clinicians called care~     managers to facilitate and support clinical treatment. The control group received usual care~     that included only referrals to mental health treatment providers. The study hypothesis is~     that telephonic care management would increase visits to mental health professionals and use~     of appropriate medication, which in turn would reduce depression severity and lead to greater~     employment and productivity at work.~   "
218832|NCT00694668|"~     Background:~      In recent years, there has been a marked rise in the frequency of young people engaging in~     Deliberate Self-Harm (DSH). DSH refers to all kinds of self-harming behaviour, with and~     without suicidal intent. Early identification and treatment of persons who engaged in DSH is~     important because every episode of DSH increases the risk of future episodes and, eventually,~     suicide. A number of comprehensive treatment programs have been developed and proven to be~     effective in reducing DSH in adults. Especially the modification of inadequate emotion~     regulation strategies seems to be essential in the prevention of future episodes of DSH. The~     first short-term results of a Dutch time-limited and structured individual~     cognitive-behavioral treatment (CBT) for DSH in adolescents and young adults also showed~     positive effects on repetition of DSH and associated problems.~      Objective:~      To study the effects and costs of the total individual CBT package and one of the components~     of the total CBT treatment package (i.e. mindfulness training) in a group format compared to~     Treatment-as-Usual (TAU) on the short and long term.~      Design:~      Multi-center randomized controlled clinical trial with repeated measurements at baseline~     (M0),and posttreatment (M6)), 12 (M12) and 18 months (M18) after baseline.~      Procedure:~      Young persons aged 15-35 who recently have engaged in DSH and have been referred to the~     Leiden University Medical Centre, the mental health centre Rivierduinen or the University~     Medical Centre St. Radboud following an act of DSH will be invited to participate. Persons~     reporting severe psychiatric disorders requiring intensive inpatient treatment or serious~     cognitive impairments will be excluded.~      Interventions:~      Participants are randomly allocated to CBT, Mindfulness-Based Cognitive Therapy(MBCT) or~     Treatment-as-Usual (TAU). The CBT treatment consists of up to 12 weekly sessions of~     individual treatment mainly consisting of emotion regulations skills, cognitive~     restructuring, and behavioural skills training. The MBCT training consists of 8 2-hour~     sessions in a group format within a three months time frame.~      Outcome measures:~      The same outcome measures to assess the clinical effects of treatment as in the previous~     study will be used (repetition of DSH, depression (BDI-II), anxiety (SCL-90),~     self-concept(RSC-Q), and suicide cognitions (SCS)) allowing a historical comparison of~     treatment effectiveness across both randomized clinical trials. In addition at all~     assessments health-related quality of life, use of medical resources and loss of productivity~     will be assessed (EuroQol, VAS and TTO). In addition,problems in emotion regulation (an~     important risk mechanism for repetition of DSH) will be assessed before and after treatment.~      Economic evaluation:~      Differences in societal costs (intervention, other (health) care and productivity)will be~     compared to differences in the frequency of DSH and quality adjusted life years (EuroQol, VAS~     and TTO).~      Data-analysis/power:~      Based on our previous study at least a medium effect of treatment on repetition of DSH may be~     expected. Assuming a medium effect of one of the treatments compared to TAU (delta =.75) and~     an attrition rate of about 20 %, at least 42 patients per study arm are needed to detect a~     minimal clinical relevant difference in repetition of DSH with a power of 80% and alpha set~     at .05.~   "
218847|NCT00694473|"~     We hypothesize that measurements of interstitial fluid (ISF) glucose by the FreeStyle~     Navigator (Abbot Diabetes Care), a continuous glucose monitoring system, will correlate with~     blood glucose (BG) values in surgical and ICU patients with a clinically useful degree of~     accuracy.~   "
220179|NCT00676884|"~     The primary objective of this study is to investigate the effect of AERODERM (also known as~     pitrakinra, AER 001, BAY 16-9996) on Eczema Area and Severity Index (EASI) score in subjects~     with moderate to severe atopic eczema~   "
218833|NCT00694655|"~     The objective of this study is to study immune memory generated against the yellow fever~     vaccine (YFV) in participants who recently received the YFV vaccine. Volunteers who are~     planning to travel to yellow fever endemic areas will be recruited into this study.~     Volunteers will receive the yellow fever vaccine at the Hope Clinic of Emory University or at~     their private health care provider's office. Blood tests will be drawn before the vaccination~     and at upto 8 visits following vaccination. A volunteers's study participation may will last~     as short as 1 month or as long as one year depending on the immune responses.~      We plan to compare the immune responses in younger people (18 to 45 years) to that of older~     people (55 or above).~   "
218834|NCT00694642|"~     The purpose of this study is to determine whether transendocardial injections of autologous~     endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.~   "
218835|NCT00694629|"~     Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial~     activity and safety of an experimental intensive phase (first 8 weeks of treatment)~     tuberculosis treatment regimen in which rifapentine is substituted for rifampin.~      Primary Objective~        -  To compare the antimicrobial activity and safety of standard daily regimen comprised of~          rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to~          that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) +~          isoniazid + pyrazinamide + ethambutol (PHZE).~      Secondary Objectives~        -  To determine and compare for each regimen the time to culture-conversion, using data~          from 2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses).~        -  To determine and compare for each regimen the proportion of patients with any Grade 3 or~          4 adverse reactions~        -  To determine the correlation of the MGIT/BACTEC liquid culture growth index and other~          mycobacterial and clinical biomarkers with time to culture conversion and treatment~          failure~        -  To store serum for future assessment of biomarkers of TB treatment response and~          hypersensitivity to study drugs.~        -  To compare adverse events and 2-month culture conversion rates among HIV-infected~          patients vs. HIV-uninfected patients~        -  To determine the tolerability and safety, and estimate the antimicrobial activity, of~          experimental regimens that include isoniazid + pyrazinamide + ethambutol plus either~          rifapentine 15 mg/kg/dose or rifapentine 20 mg/kg/dose, all administered daily.~          Assessment of these doses of rifapentine will be performed as an extension to the main~          study after enrollment in the main study has been completed.~      Design~      This will be a prospective, multicenter, open-label clinical study. Adults suspected of~     having pulmonary tuberculosis who meet eligibility criteria will be randomized to receive~     either the experimental intensive phase tuberculosis treatment regimen or the standard~     intensive phase tuberculosis treatment regimen. Randomization will be stratified by~     presence/absence of cavitation on baseline chest radiograph, and by geographic continent. All~     doses of study drugs will be given under direct observation and administered 5 days per week.~     After a subject completes intensive phase therapy, he/she then will be treated with a~     non-experimental continuation phase tuberculosis treatment regimen.~      The study extension will be a prospective, multicenter clinical trial. Eligibility criteria~     will be the same as for the main study. Participants will be randomized to one of four~     regimens: the standard intensive phase treatment regimen, an investigational regimen in which~     rifapentine 10 mg/kg/dose is substituted for rifampin, an investigational regimen in which~     rifapentine 15 mg/kg/dose is substituted for rifampin, or an investigational regimen in which~     rifapentine 20 mg/kg is substituted for rifampin. Randomization will be stratified by the~     presence/absence of cavitation on baseline chest radiograph, and by study site. Study drugs~     will be administered 7 days per week. After a subject completes intensive phase therapy,~     he/she then will be treated with a non-experimental continuation phase tuberculosis treatment~     regimen. Subjects will have blood drawn for one pharmacokinetic determination of rifapentine~     concentration at or after the week 2 visit during intensive phase therapy.~      This study is being conducted in 2 phases.~        1. The main study compares a 10 mg/kg dose of rifapentine, open label, against 10 mg/kg~          rifampin in an otherwise standard intensive phase regimen of treatment for pulmonary~          tuberculosis. The projected sample size was 480 enrollments; 530 patients were actually~          enrolled.~        2. The study extension evaluates higher doses of rifapentine, with the specific rifapentine~          doses (10 mg/kg, 15 mg/kg, and 20 mg/kg) blinded to patients and clinicians, with data~          collection and endpoints otherwise similar to the main study. The projected sample size~          for the study extension is 320 enrollments.~   "
218836|NCT00694616|"~     Metabolic syndrome is a constellation of risk factors for cardiovascular disease. The~     prevalence of metabolic syndrome in persons with obstructive sleep apnea syndrome (OSAS) is~     known to be very high, about 70%. However, it is unclear whether this association is causal~     or not. Results of earlier studies have been conflicting. The investigators hypothesize that~     treatment with auto-titrating continuous positive airway pressure (auto-CPAP) for a duration~     of 3 months improves the metabolic syndrome in subjects with OSAS.~   "
218837|NCT00694603|"~     The purpose of this research study is to find out how well cetuximab works in treating NSCLC~     in patients who have been previously treated with a class of drug called tyrosine kinase~     inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells~     called epidermal growth factor receptor or EGFR. EGFR helps cancer cells grow.~   "
218838|NCT00694590|"~     The purpose of this research study is to determine if plerixafor can make CLL/SLL (Chronic~     Lymphocytic Leukemia/ Small Lymphocytic Lymphoma) cells more sensitive to being killed by~     rituximab, an anti-cancer drug that is commonly used in treating CLL and SLL. In this study,~     plerixafor will be added to standard treatment with rituximab. Subjects will be monitored to~     see how well they tolerate the use of these drugs together and how well they work to treat~     the leukemia.~      The primary objective is to determine the maximum tolerated dose (MTD) of plerixafor when~     combined with rituximab as treatment for previously treated patients with CLL or SLL.~   "
218839|NCT00694577|"~     The purpose of this study is to determine the feasibility of partial breast irradiation in~     participants with early invasive or non-invasive breast cancer.~   "
218840|NCT00694564|"~     This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent~     abdominal pain in children. This will be an open-labeled study and all participants will~     receive SAM-e therapy. Given that SAM-e has been demonstrated to improve symptoms of~     depression and pain with minimal side effects as compared to other antidepressant therapy, we~     hypothesize that SAM-e will reduce pain symptoms among children with recurrent abdominal~     pain.~   "
218841|NCT00694551|"~     Pilot Immunotherapy Study of Combination Prostate Specific Membrane Antigen (PSMA) and T-cell~     receptor γ alternate reading frame protein (TARP) Peptide With Poly IC-LC Adjuvant in Human~     Leukocyte Antigens (HLA)-A2 (+) Patients With Elevated prostatic specific antigen (PSA) After~     Initial Definitive Treatment~      The purpose of the study is to see if the PSMA/TARP proteins in the vaccine, along with the~     Hiltonol, can arouse and train the immune system to kill the prostate cancer cells. Prostate~     cancer is the most common cancer and is the second leading cause of cancer deaths in U.S.~     males. It is curable when it is confined to the prostate (kept from spreading) using surgery~     or radiation treatments. In some patients the cancer can come back after these treatments.~     Treatment options for prostate cancer that comes back include procedures or medications which~     may have significant risks and side effects. Another plan is being looked at that uses the~     body's immune system to attack prostate cancer cells. A vaccine has been developed that has~     proteins found in prostate cancer cells. One of the proteins is called PSMA and the other is~     called TARP. In addition to these proteins, another substance called Poly IC-LC (Hiltonol)~     will be added to the vaccine to boost its ability to start the immune system.~   "
218842|NCT00694538|"~     The purpose of this study is to determine the advantages of the interferential laser therapy~     in shoulder pain reduction compared with the conventional low level laser therapy modality.~   "
218843|NCT00694525|"~     21-hydroxylase deficiency (21-OHD) is an inherited disorder that results from a mutation on~     the CYP21A2 gene. It affects the adrenal glands and is the most common cause of congenital~     adrenal hyperplasia (CAH). 21-OHD CAH causes the body to produce an insufficient amount of~     cortisol and an excess of androgen, the type of hormone that produces male characteristics.~     The primary treatment for 21-OHD CAH, glucocorticoid replacement therapy, has been shown to~     cause bone loss. However, the elevated hormone levels caused by 21-OHD CAH may increase~     production of the protein osteoprotegerin (OPG), which in turn may protect against bone loss.~     This study will compare bone density and OPG levels in women who have 21-OHD CAH and have~     undergone a lifetime of glucocorticoid replacement therapy to that in women who have neither~     of these criteria. In doing so, the study will aim to determine the relationship between OPG~     and bone loss.~   "
218844|NCT00694512|"~     The purpose of this study is to learn more about how diet affects the hormone ghrelin.~     Ghrelin is made in the stomach and causes appetite to increase. Learning about ghrelin will~     help the investigators understand more about obesity.~   "
218845|NCT00694499|"~     Little is known about the role of collateral damage in patients with high grade liver~     injuries (LI). This retrospective single centre study investigates the safety of the~     non-operative management of patients with high grade blunt liver injuries (NOMLI) and the~     impact of to the LI collateral intra- and extra-abdominal damage on interventions and~     outcome. We first hypothesized that NOMLI can be safely achieved also in high-grade liver~     injured patients, the management of trauma patients with LI mainly consist of the treatment~     of collateral damages and their complications, and causes of death are in the majority of~     cases not liver related. A retrospective study involving 183 patients with blunt hepatic~     injuries was therefore carried out to investigate these hypotheses.~   "
218846|NCT00694486|"~     This study will compare Eustachian tube function (ETF) testing in adults with intact tympanic~     membranes (TM) using a pressure chamber to that obtained using standard methods requiring a~     non-intact TM.~   "
218848|NCT00694460|"~     This study evaluated the safety and immunogenicity of rabies vaccine and Japanese~     encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies~     vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis~     vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic~     when administered concomitantly to toddlers.~   "
218849|NCT00694447|"~     The hypotheses of this study are: In the older population with knee OA,~        -  When acupoints are chosen for both sleep and pain, there are additive effects on sleep~          improvement and pain relief (i.e. no interaction).~        -  Main effects of acupuncture on sleep improvement and pain relief are anticipated when~          acupoints are separately targeted for sleep and for pain, respectively.~   "
218850|NCT00694434|"~     Evaluation of embryo quality in the fresh cycle as a predictor of outcome from frozen embryo~     transfer.~   "
218851|NCT00694421|"~     This study will test the hypothesis that constitutionally poorer Eustachian tube function~     predisposes to middle-ear pathology during a viral upper respiratory infection.~   "
218852|NCT00694408|"~     Objective:~      The overall objective is to investigate whether a steroid free immunosuppressive regimen is~     as safe and effective as a steroid containing regimen following pediatric liver~     transplantation and whether it promotes tolerance.~   "
218853|NCT00694395|"~     To identify the circumstance during decision making processes to seek medical help in~     patients with symptoms of acute ischemic stroke.~   "
218854|NCT00694382|"~     The primary objective was to compare the efficacy of once daily subcutaneous injections of~     Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE]~     in cancer patients at high risk for VTE and who were undergoing chemotherapy.~      The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to~     document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of~     VTE and to assess the survival status at one year in this population.~   "
218855|NCT00694369|"~     The purpose of this study is to compare the pain relieving effect of different doses of~     MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental~     pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and~     patient evaluation.~   "
218856|NCT00694356|"~     This clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity~     of dalotuzumab (MK-0646) in participants with relapsed or refractory locally advanced or~     metastatic solid tumors using once weekly and once every other week dose infusion regimens.~      The primary study hypothesis is that administration of dalotuzumab as a once weekly and an~     every other week infusion will be generally safe and well tolerated~   "
218857|NCT00694343|"~     The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal~     hypotension in women undergoing spinal anesthesia for cesarean section~   "
218858|NCT00694330|"~     This research study is testing the safety of a vaccination of cells called GM-K562 cells~     mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified~     in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating~     an immune response to cancer. This newly developed vaccine may stop cancer cells from~     growing.~   "
218859|NCT00694317|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon~     Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a~     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design~   "
218860|NCT00694304|"~     The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine~     over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed~     8-week acute treatment.~   "
218861|NCT00694291|"~     The purpose of this study is to measure the benefit of sorafenib in patients with a rising~     PSA after treatment with radiation therapy or surgery who are NOT receiving with androgen~     ablation therapy.~   "
218862|NCT00694278|"~     The aim of this study and the primary outcome is to clinically evaluate effect of~     laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will~     evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be~     followed closely to ensure the desired results are sustained in long term~   "
218863|NCT00694265|"~     In wrists with carpal tunnel syndrome (CTS) the sonographically measured largest~     cross-sectional area (CSA) of the median nerve is increased. We compared the changes in~     largest CSA in wrists undergoing surgical decompression and wrists undergoing conservative~     treatment of CTS.~   "
218864|NCT00694252|"~     This study will evaluate the efficacy of lapatinib in eradicating chemo- resistant tumour~     cells circulating in the blood of patients with breast cancer.~   "
218865|NCT00694239|"~     The RATCHET study assesses if patient knowledge of estimated cardiovascular risk at current~     and recommended target blood pressure levels improves compliance in the management of~     hypertension.~   "
218866|NCT00694226|"~     The objective of the study was to assess the efficacy in decreasing the likelihood of~     substance use of a brief motivational enhancement intervention in adolescents referred to~     psychiatric treatment.~      237 adolescents consecutively admitted to a psychiatry department completed an evaluation of~     their substance use. Subjects identified as users were randomly allocated to one of two~     groups: an experimental group that received a brief intervention aimed at increasing their~     awareness of the risks of substance use, or a control group. All subjects received standard~     treatment according to the primary diagnosis. Structured questionnaires assessing knowledge,~     attitudes, perception of risks and intention of use of psychoactive substances were~     administered upon admission and 1 month later.~   "
218867|NCT00694213|"~     The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled~     in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations~     with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the~     immune system's response to the vaccine. The safety and immune system's response will be~     studied throughout the trial.~   "
218868|NCT00694200|"~     To evaluate the efficacy of metronomic oral vinorelbine taken three times a week without~     break plus bevacizumab as salvage treatment in patients with metastatic breast cancer.~   "
221178|NCT00663741|"~     This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of~     sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable /~     recurrent gastric cancer.~   "
218869|NCT00694187|"~     The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon~     Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a~     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design~   "
218870|NCT00694174|"~     The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is~     able to measure the effect of pain related changes in skin blood flow in newborn infants. The~     study will also determine whether the use of sucrose (sugar water) when given by mouth has~     any effect on pain related skin blood flow changes.~   "
218871|NCT00694161|"~     Open-label, multicenter, international, single-treatment study designed to determine TTR~     stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical~     outcomes in patients with V122I or wild-type TTR amyloid cardiomyopathy.~      The study will be conducted in two parts. Part 1 will include a six-week dosing period during~     which all enrolled patients will self-administer oral Fx-1006A 20 mg soft gelatin capsules~     once daily for six weeks. At Week 6, blood samples will be collected from each patient to~     determine TTR stabilization. Patients who complete the Week 6 visit will continue taking~     daily oral Fx 1006A 20 mg for up to a total of 12 months during Part 2 of this study. If it~     is determined that a patient is not stabilized at Week 6 (based on TTR stabilization data),~     the patient will be discontinued from the study. Safety and clinical outcomes will be~     evaluated during Part 2 of this study.~      Two whole blood samples for pharmacodynamic assessments (TTR stabilization) and~     pharmacokinetic assessments (Fx-1006A concentrations as well as calculated steady-state~     parameters) will be collected at Baseline and Week 6. At Months 6 and 12, two whole blood~     samples will be collected for pharmacodynamic assessments, and four whole blood samples (two~     samples per time point) will be collected for pharmacokinetic assessments to be utilized in~     population pharmacokinetic modeling.~      Echocardiography, chest x-ray, cardiac MRI, and 24-hour Holter monitoring will be conducted~     at Baseline, and Months 6 and 12. Six-minute walk test and quality of life utilizing the~     Patient Global Assessment, KCCQ, and SF-36 will be assessed at Baseline, and Months 3, 6, and~     12. NYHA Classification will be assessed at Baseline, Week 6, and Months 3, 6, and 12. Serum~     markers of troponin I and T, and NT-pro-BNP levels will be assessed at each study visit.~      Safety and tolerability will be assessed throughout the study. Vital signs, 12-lead ECG,~     blood and urine samples for clinical laboratory tests (serum chemistry, hematology,~     coagulation panel, and urinalysis), AEs, and concomitant medications (including diuretic~     usage) will be assessed at each study visit. Abbreviated physical examinations will be~     conducted at Baseline, Weeks 2 and 6, and Months 3 and 6, and a complete physical examination~     will be conducted at Month 12.~      Clinic visits will be conducted during Screening (Days -30 to -1) and Baseline (Day 0);~     procedures scheduled for the Baseline visit may be conducted over a period of one week to~     accommodate patient scheduling. All Baseline procedures must be completed prior to the first~     self-administered dose on Day 1. Day 1 will be defined as administration of the first dose of~     study medication, which patients will self-administer at home. During treatment, clinic~     visits will be conducted at Week 2 (± 2 days), Week 6 (± 1 week), Month 3 (± 1 week), Month 6~     (± 2 weeks), and Month 12 (± 2 weeks). Procedures scheduled for the Month 6 and 12 visits may~     occur over one week during the visit window to accommodate patient scheduling. Monthly~     telephone contacts (± 1 week of the scheduled date) will be made during months in which no~     clinical site visits are scheduled (Months 4, 5, 7, 8, 9, 10, and 11) for assessment of AEs~     and concomitant medications. A final telephone contact to assess AEs and concomitant~     medication usage will be made 30 days after the last dose of study medication for each~     patient.~      Patients who discontinue from the study at any time will have a final visit performed,~     including all safety assessments, at the time of discontinuation. Any patient discontinuing~     after the Month 6 visit will also have all exploratory assessments performed.~   "
218872|NCT00694148|"~     NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the~     muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin~     type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate~     the safety and efficacy of NT 201 in the treatment of glabellar frown lines.~   "
218873|NCT00694135|"~     The purpose of this study is to define a safe and effective dose of iontophoretic delivery of~     dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in~     patients with non-infectious anterior segment uveitis.~   "
218874|NCT00694122|"~     1. To investigate the effect of insulin glargine (Lantus™) vs NPH insulin regarding~          glycemic control during the early AM (dawn phenomenon) in individuals with type 1~          diabetes.~        2. To measure hormones implicated in the pathogenesis of the dawn phenomenon in individuals~          with type 1 diabetes.~   "
218875|NCT00694109|"~     To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in~     participants with familial hypercholesterolemia or severe hypercholesterolemia on~     lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7~     (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.~   "
218876|NCT00694096|"~     This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in~     20 evaluable patients with metastatic renal cell cancer (RCC) and an early post therapy~     assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5~     patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard~     approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an~     assessment of tumor metabolism [Bannasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005,~     Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A,~     Weber 1977B] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields 2001, Shields 1998,~     Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI)[Lodge~     2000], tumor perfusion (DCE-MRI)[Tofts 1999, Tofts 1997, Parker 1999]; and tumor blood volume~     (H215O-PET, DCE MRI)[Lodge 2000, Tofts 1999, Tofts 1997] in the same patient at baseline and~     then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or~     4 weeks). We hypothesize that by using this set of imaging assessments it will be possible to~     determine an individual or more likely a set of imaging derived biomarkers that will~     accomplish several of the goals of the initiative which is providing funding for the study.~   "
218877|NCT00694083|"~     A clinical study evaluates the safety, tolerability, and pharmacokinetics of ridaforolimus~     (MK-8669) in participants with locally advanced or metastatic solid tumors.~   "
218878|NCT00694070|"~     The purpose of this study is to evaluate a diabetes data management program in the hands of~     potential users, both health care professionals and lay users.~   "
218879|NCT00694057|"~     This is a phase II, double-blind, randomized, placebo-controlled study of the safety,~     tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients~     receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or~     placebo) for a treatment period of 12-weeks.~   "
218880|NCT00694044|"~     1. Characterize the tolerability and safety of repeated doses of varenicline in healthy~          non-smoking elderly subjects.~        2. Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly~          subjects.~        3. Evaluate the potential effects of repeat doses of varenicline on cognition in healtly~          non-smoking elderly subjects.~   "
218881|NCT00694031|"~     Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional~     hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and~     a sample size of around 750 will be necessary to detect a 35% reduction in mortality.~   "
218882|NCT00694018|"~     The objective of this study was to assess whether an Internet-mediated pedometer based~     intervention would increase walking and improve function among individuals with chronic back~     pain.~   "
218883|NCT00694005|"~     Few data are available about the late patency of side branches in association with the~     currently used stent types and implantation techniques.~   "
218884|NCT00693992|"~     This randomized phase III trial studies sunitinib malate to see how well it works when given~     as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients~     with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with~     combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth and by blocking the growth of new blood vessels~     necessary for tumor growth. It is not yet known whether sunitinib malate is effective in~     helping tumors continue to shrink or stop growing.~   "
218885|NCT00693979|"~     This study is to compare the safety and performance of two stents coated with the same drug~     (the TAXUS Element Paclitaxel-Eluting Coronary Stent System and the TAXUS Express2~     Paclitaxel-Eluting Coronary Stent System).~   "
218886|NCT00693966|"~     The purpose of this Phase II study is to provide data regarding the safety and immunogenicity~     for a range of dose levels of MEDI-517 in women who are HPV-16/18 seronegative and negative~     for high-risk HPV DNA. The study is designed to evaluate safety and immunogenicity data for~     MEDI-517 when formulated with either AS04 or aluminum hydroxide. Extended follow-up will~     provide long-term immune response data.~      This study was originally performed by MedImmune. However, GSK is now responsible for the~     clinical development of the HPV vaccine.~   "
218915|NCT00693576|"~     Patients with panel reactive antibodies have many difficulties to find a crossmatch-negative~     kidney for transplantation and are at the risk of post transplantation rejection more than~     other transplanted patients. We evaluated the effect of simvastatin on PRA and post~     transplant outcome of these sensitized patients. We also performed a descriptive study.~   "
218887|NCT00693953|"~     Individuals with Autism Spectrum Disorder will have abnormal DESA® results. Our objective is~     to use neuroelectrical measures to determine the degree of processing abnormalities in~     individuals with Autism. The study will survey processing patterns and will locate and~     evaluate the degree(s) of abnormalities for further study. The abnormal results of~     comprehensive neuroelectrical evaluations of individuals with Autism when compared to the~     normative database will provide objective, verifiable, neurophysiological information with~     which to form novel approaches to the disorder.~   "
218888|NCT00693940|"~     Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or~     plaque, accumulates in the arteries of the legs. People with lower extremity PAD often~     experience leg pain while walking, which is caused by reduced blood flow to the legs. Regular~     walking has significant benefits for people with blood flow problems in their legs, but~     previous studies have shown that most men and women with PAD do not walk for exercise on a~     regular basis. A group home-based walking program may help people with PAD to walk more often~     and improve their lower extremity functioning. This study will evaluate the effectiveness of~     a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people~     with lower extremity PAD to increase their walking frequency and improve their lower leg~     functioning.~   "
218889|NCT00693927|"~     Prospective randomized study of allogeneic minitransplantation from HLA-identical family or~     unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will~     be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x~     30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). Patients will~     receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate~     mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. The rationale for~     using PBSC instead of marrow transplant is to avoid general anesthesia of the donor and to~     minimize the risk of rejection. The rationale for CD8+ depletion is to diminish the risk of~     GVHD after PBSC transplantation or DLI.~   "
218890|NCT00693914|"~     Children treated with radiation therapy for brain tumors are at risk for cognitive problems.~     These problems have typically been demonstrated on global cognitive measures including~     measures of intellectual functioning (IQ). Identification of specific areas of impairment can~     assist in isolating vulnerable brain areas and developing targeted interventions.~      In this study, we assess brain tumor survivors, solid tumor controls and healthy sibling~     controls using measures of working memory (online maintenance and manipulation of~     information) in order to identify a specific cognitive process that may underlie the observed~     decline in IQ. We are also exploring relationships among working memory performance with IQ,~     clinical characteristics and a specific genetic factor of interest.~   "
218891|NCT00693901|"~     Engaging in physical activity is an important health behavior for maintaining good health and~     preventing disease. Public parks offer community members readily accessible areas for~     recreation and exercise. Modifying park programs and facilities to meet the specific needs of~     community members may encourage people to engage in more physical activity. Furthermore,~     using feedback from the community might be the best way to determine how park funds should be~     allocated for modifications. This study will compare two approaches to park programming and~     will determine which approach is best at increasing physical activity within the community.~   "
218892|NCT00693888|"~     The Geriatric Center Ulm scientifically supported a three-year pilot study (ProjektDEMENZ~     Ulm), in which numerous findings on the system of care regarding people suffering from~     dementia and their relatives were determined.~      One of the most important conclusions is the significant lack of information on the~     well-functioning network of the care system in Ulm. The full potential of the network is not~     being exploited.~      The situation in the Alb-Donau-Kreis - the area surrounding Ulm - is very similar.~      The investigators' aim is to improve the utilization of the system of care for those~     suffering from dementia in Ulm/Alb-Donau-Kreis by using a newly designed advisory approach~     (Lighthouse Project on Dementia, Ulm, ULTDEM study).~      The purpose of the study is to prove the effectiveness of this procedure by using a~     prospective, open, randomized, controlled, interventional study.~      After the randomization, the interventional group is given comprehensive, individual advice~     about available treatment possibilities for people suffering from dementia.~      In addition, they have the opportunity to re-evaluate their present diagnostic procedure.~      The participants of the control group receive the standard treatment. Inclusion criterion is~     the application of a care level ( level 0 or 1). Recruitment will take one year. A final~     assessment will be taken every six months.~   "
218893|NCT00693875|"~     Medical literature about awareness during general anesthesia is rare in China, and some small~     sampled studies in China showed a significantly higher incidence (1.5～6%) of intra-operative~     awareness compared with western countries. The investigators sponsored this multicenter,~     large sampled, prospective study to determine the incidence of intra-operative awareness in~     China, and the preservation effect of BIS monitor on the incidence of awareness.~   "
218894|NCT00693862|"~     The purpose of this study is to show that higher minimum concentration values are obtained~     following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment~     with corresponding dosing regimen.~   "
218895|NCT00693849|"~     The aim of this study is to identify genetic, physical (brain) and psychological (cognitive)~     markers (or combinations of them) that predict specific response to a range of~     antidepressants treatment (Escitalopram, Venlafaxine, Sertraline) in patients diagnosed with~     major depressive disorder. This study is focused on outcomes which may impact on how~     personalised medicine is implemented in depression.~   "
218896|NCT00693836|"~     RATIONALE: Gathering information about genetic and environmental factors from patients with~     lung cancer and their partners and first-degree relatives may help doctors learn more about~     the disease.~      PURPOSE: This clinical trial is looking at the patterns, causes, and control of disease in~     patients with lung cancer in the North Trent (England) region.~   "
218914|NCT00693589|"~     Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts)~     with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to~     improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and~     inflammatory markers. B-group vitamin-supplements have variable been reported to have~     positive or neutral effects on endothelial function. Therefore, we want to compare the effect~     of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm~     resistance vessels in pts with cardiovascular disease.~   "
218897|NCT00693823|"~     This study is a comparison of two different ways to treat blockage in the artery of the~     thigh. The first is an older way with incisions in the groin and just above the knee. A~     plastic tube is then inserted to make a bypass from the groin to the knee. The second~     treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal~     stent is inserted into the artery and released to bypass the blockage from inside the artery.~     No incisions are needed. Patients are enrolled and then selected for one treatment method or~     another by chance. The patients will be followed for two years to see how the two different~     treatment methods work compared to each other.~   "
218898|NCT00693797|"~     As there are no clinical data in cardiology about the relationship between metabolism~     collagen changes and their clinical significance, the investigators will check the hypothesis~     that collagen metabolism changes, detected by biochemical markers for collagen metabolism,~     could predict the left ventricle remodelling and prognosis in patient with clinically~     significant pressure overloaded left ventricle.~   "
218899|NCT00693784|"~     The purpose of this study is to assess the safety of the Biostat Disc Augmentation System for~     the treatment of chronic low-back (lumbar) pain due to symptomatic internal disc disruptions~     (IDD) and to obtain preliminary efficacy information.~   "
218900|NCT00693771|"~     Primary objective:~      To show an improvement in HbA1c control after 4 months of treatment with insulin glargine +~     Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD)~      Secondary objective:~      Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to~     target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life~     with basal+ OAD regimen.~   "
218901|NCT00693758|"~     The ability of a new SSFP-based BOLD MRI sequence to assess myocardial oxygenation changes in~     response to coronary flow changes induced by adenosine and increased CO2-partial pressure~     will be examined in healthy volunteers and patients with suspected coronary artery disease.~     Also the susceptibility of a new SSFP-based BOLD sensitive MRI sequence to changes in~     arterial oxygenation will be examined. This will help understand the physiologic basis of~     oxygen sensitive imaging of the heart.~   "
218902|NCT00693745|"~     This is a multi-center prospective pilot clinical study to assess the utility of the Triage~     NGAL Test - alone and in conjunction with the Triage BNP test - as an aid in the early risk~     assessment for heart-failure-related adverse clinical outcomes (deaths, readmissions, and~     additional emergent outpatient visits) through Day 30 and Day 90 in patients presenting with~     acutely decompensated heart failure (HF). Its utility as an aid in the early risk assessment~     for renal dysfunction in patients with acutely decompensated heart failure undergoing~     treatment with IV diuretics will also be assessed.~   "
218903|NCT00693732|"~     Visceral and somatic hypersensitivity as evidence of central sensory sensitization occur in~     the majority of Irritable Bowel Syndrome (IBS) patients. We recently demonstrated abnormal~     endogenous pain modulation as a cause of the sensitization in IBS and identified the~     underlying dysfunctional neuromatrix using functional MR-imaging (fMRI). Endogenous pain~     mechanisms regulate, fine-tune and integrate sensory and homeostatic, including~     neuroendocrine, immune and autonomic nervous system processes. Specific measures of~     sensitization and endogenous pain modulation correlate with clinical measures of somatic and~     neuropathic pain, suggesting usefulness as surrogate markers for clinical pain outcomes.~     Validation of experimental measures as surrogate markers in IBS would provide a considerable~     advance in pathophysiological and therapeutic research in this pharmacoeconomically~     burdensome disease.~   "
218904|NCT00693719|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide~     works in treating patients with recurrent, locally advanced, or metastatic breast cancer.~   "
218905|NCT00693706|"~     The purpose of the study is to compare the safety of & immune response to a single dose of~     GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed,~     egg-based trivalent influenza vaccine [Fluarix] in healthy adults.~   "
218906|NCT00693693|"~     The purpose of this research study is to better understand adherence to Locoid when people~     use it to treat atopic dermatitis.~   "
218907|NCT00693680|"~     Examination of the effect of zinc supplementation on imipramine therapy in major depression.~   "
218908|NCT00693667|"~     The primary objective of this clinical study is to evaluate the effectiveness and safety of~     PH3 for the prevention of osteoporosis.~      The secondary objectives are to identify the optimal dosage for subsequent studies and to~     provide basis for the next confirmatory study in study design, endpoints, and study~     methodologies.~   "
218909|NCT00693654|"~     The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in~     the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled~     comparative trial.~   "
218910|NCT00693641|"~     The purpose of the study is to investigate the effectiveness of a sun lotion containing a~     specific Jellyfish sting inhibitor versus regular sun lotions as controls. In addition, to~     investigate the effectiveness of hot/cold immersion for the treatment of Cyanea sp stings~     versus local pain relief with prescription free pharmaceutical drug (Xylocain 30 mg/ml (3%)~     lidocain).~   "
218911|NCT00693628|"~     We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly~     than control subjects who wear no shrinkers. We also expect them to experience greater~     reduction in residual limb volume during the early stages of postoperative care leading up to~     prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting,~     increased time to the first prosthetic socket replacement, and fewer socket replacements by~     the end of the transition to stable phase.~   "
218912|NCT00693615|"~     The goals of this study are to describe the safety, reactogenicity and immunogenicity of~     MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected.~      This study was originally performed by MedImmune. However, GSK is now responsible for the~     clinical development of the HPV vaccine.~   "
218913|NCT00693602|"~     This is a compassionate use protocol for patients with acute lymphoblastic leukemia (ALL) who~     have developed hypersensitivity or intolerance to E. coli L-asparaginase and/or~     PEG-L-asparaginase.~   "
218916|NCT00693563|"~     The purpose of this study is to evaluate whether scheduled telephone intervention with~     individuals with spinal cord injury (SCI) and their caregivers in the first year following~     discharge from acute inpatient rehabilitation will reduce rehospitalizations and emergency~     room visits as well as improve adjustment to SCI.~   "
218917|NCT00693550|"~     RATIONALE: Gathering information about allergies to metals may help doctors learn whether~     having an allergy to metal used in dental work increases the risk of developing oral cancer.~      PURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk~     factor for oral cancer.~   "
218918|NCT00693537|"~     Patients with type 2 diabetes mellitus suffer from accelerated coronary artery disease. We~     will assess the effects of exercise training on coronary endothelial function, vascular~     structure, and inflammation both in serum and skeletal muscle biopsies, as well as expression~     of diabetes candidate genes.~   "
218919|NCT00693524|"~     Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a~     combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab),~     in comparison with a standard steroid + tacrolimus double drug regimen~   "
218920|NCT00693511|"~     The overall goal of this project is to examine the physiological and metabolic effects of a~     16-week circuit-training (strength training + aerobic activities) program, with and without a~     behavioral component utilizing motivational interviewing, in 45 overweight Latina adolescent~     girls (14-18 years of age). This 16-week randomized control study will examine the~     incremental effects of the following 3 intervention groups on insulin sensitivity, insulin~     secretion, adiposity, and habitual and ad libitum physical activity:~        -  Control group (delayed circuit training intervention; n=15)~        -  Circuit training group (strength + aerobic training; 2 times per week; n=15)~        -  Circuit training (same as above) + weekly motivational interviewing sessions (n=15)~      Specific Aim 1: To examine the effects of a 16-week circuit training program on adiposity,~     insulin dynamics, other associated hormones and adipocytokines, cardiorespiratory fitness,~     and muscular strength in overweight Latina adolescent girls. Hypothesis 1: Participation in~     the circuit-training program will result in significant improvements in both physiological~     and metabolic outcomes, including: a) body composition as measured by DEXA, b) fat~     distribution as measured by MRI, c) adipose tissue hormones (e.g. leptin, adiponectin, TNF-α)~     as measured by fasting blood samples, d) insulin sensitivity and secretion as measured by~     frequently sampled intravenous tolerance test, e) aerobic fitness as measured by the single~     stage submaximal treadmill test, and f) increase muscular strength as measured by repetition~     maximums.~      Specific Aim 2: To examine the incremental effects of adding the motivational interviewing~     sessions to the circuit training on self-selected ad libitum physical activity during a~     5-hour observational period, habitual physical activity levels using 7 day accelerometry, and~     the meanings and motivation to exercise using questionnaires before and after the~     intervention. Hypothesis 2: The addition of motivational interviewing will encourage and~     empower participants to be more active outside of the intervention and foster healthy~     physical activity behaviors in daily life. Improvements in physical activity behaviors will~     lead to greater improvements in all other health outcomes listed in specific aim 1 compared~     to circuit training alone and control group.~   "
218921|NCT00693498|"~     Background: Children having open heart surgery to repair congenital heart defects demonstrate~     a large inflammatory response to the heart-lung machine and to surgery itself. In general,~     the more intense their inflammatory response, the more critically ill they are following~     surgery. These children routinely require large numbers of blood transfusions during and~     following surgery as part of their medical management that adds to their heightened~     inflammatory state. Whether additional steps to wash blood products and remove the~     substances contributing to post-transfusion inflammation will limit this response, and~     improve the health of children following open heart surgery, remains to be studied.~      Aims: To compare the inflammatory response in children having open heart surgery who receive~     washed versus unwashed blood transfusions.~      Methods: We will randomly assign children having open heart surgery to one of two groups:~     group 1 will receive blood transfusions per the current standard of care, group 2 will~     receive blood transfusions that have been washed in addition to the current standard of care.~     We will then use blood tests to measure the inflammatory response in children of each group.~     We will compare the results to determine whether washing blood transfusions decreases~     inflammation and post-operative complications following open heart surgery.~      Conclusion: We believe that washing blood transfusions given to children following open heart~     surgery will decrease their inflammatory response and improve their overall health.~   "
218922|NCT00693485|"~     A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and~     effects on visual function of brimonidine intravitreal implant in patients with glaucomatous~     optic neuropathy. Patients will be followed for up to 1 year.~   "
218923|NCT00693472|"~     This study is designed to evaluate the effectiveness of preladenant in the prevention (Part~     1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute~     psychosis using the Barnes Akathisia Scale.~   "
218924|NCT00693459|"~     The purpose of this research study is to test the effectiveness of a new anoscope used while~     performing a traditional hemorrhoidectomy.~   "
218925|NCT00693446|"~     Experience with tacrolimus in pancreas transplantation has become a standard for~     immunosuppression in almost all pancreas centers over the world. Several centers have shown~     very good results in simultaneous pancreas-kidney (SPK) transplant recipients receiving~     antithymocyte globulin induction and maintenance immunosuppression consisting of calcineurin~     inhibitor and mycophenolate mofetil with or without corticosteroids.~      The use of sirolimus in SPK transplant patients has for the moment only been studied, with~     good results, in association with tacrolimus or cyclospsorine (CsA). In renal~     transplantation, there is also evidence that sirolimus (Rapamune) is a potent~     immunosuppressant that significantly reduces the incidence of acute rejection when given with~     CsA, effective as base therapy in the post-induction period. Because of Rapamune's~     effectiveness and different safety profile, it might be advantageous in terms of reduced~     nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of~     acute rejection.~      To explore this further, the following study is designed to assess the use of SRL versus TAC,~     both treatment groups including rATG plus MMF and a 3-month course of steroids in de novo~     simultaneous pancreas-kidney transplant recipients.~   "
218926|NCT00693433|"~     This phase I trial is studying the side effects and best dose of temsirolimus when given~     together with dexamethasone in treating patients with recurrent or refractory multiple~     myeloma. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving temsirolimus together with dexamethasone may kill more cancer cells.~   "
218927|NCT00693420|"~     This study evaluates the safety and effectiveness of topical bimatoprost solution for~     enhancing eyelash prominence.~   "
218939|NCT00693238|"~     The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as~     little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks)~     of radiation, without decreasing the chance of killing prostate cancer cells.~   "
218928|NCT00693407|"~     Visceral hypersensitivity as evidence of central sensory sensitization is evident in many~     patients with functional disorders such as functional dyspepsia (FD) and irritable bowel~     syndrome (IBS). We recently demonstrated both somatic hypersensitivity and abnormal~     endogenous pain modulation in IBS, both of which indicate central sensitization as a crucial~     mechanism in IBS. Endogenous pain mechanisms regulate, fine-tune and integrate sensory and~     homeostatic, including neuroendocrine, immune, motor and autonomic nervous system processes.~     Hitherto, no studies have investigated the role endogenous pain modulation in FD. Abnormal~     modulation could explain several of the symptom complexes associated with FD and provide a~     rationale for exploration of new treatments.~      The current study was designed to~        1. investigate the gastric sensitivity in FD patients and healthy controls during gastric~          capsaicin stimulation~        2. assess the endogenous pain inhibitory modulation system in FD patients and healthy~          controls during heterotopic stimulation~   "
218929|NCT00693381|"~     Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and~     steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12~     weeks it was stopped. For the others MMF remained at initial dose.~   "
218930|NCT00693355|"~     Short chain fatty acids (mainly acetate, propionate and butyrate) are produced in the large~     intestine by bacterial fermentation of unabsorbed carbohydrates, such as dietary fibers.~     Mainly butyrate is an important energy source of the mucosa and has a pivotal role in the~     regulation of mucosal proliferation, immune function and mucosal protection.~      High fiber diets increase the concentrations of colonic butyrate, what has often been~     proposed as one of its protective mechanisms. Furthermore, butyrate enemas have been proved~     effective in the treatment of ulcerative colitis. In the present study the direct effects of~     butyrate on the distal colon will be studied in 30 healthy volunteers using rectal enemas.~     The study has been divided into two parts, each part studying different parameters, which~     interfere when measured synchronously and, therefore, need to be studied separately.~      A. The effects of butyrate enemas on colonic permeability (n=15) B. The effects of butyrate~     enemas on parameters of colonic defense, integrity and inflammation (n=15) The effects of~     butyrate will be studied in a healthy and in a stressed colon. This way the protective~     effects of butyrate on intestinal stress can be studied. Prior to the main study, two small~     pilot studies will be carried out. In the first pilot study the retrograde spread of a rectal~     enema will investigated (n=2). In the second pilot study the dose and the type of a suitable~     stressor that will induce reversible damage to intestinal mucosa will be determined (n=12).~   "
218931|NCT00693342|"~     RATIONALE: Vaccines made from tumor antigens may help the body build an effective immune~     response to kill tumor cells. Biological therapies, such as OPT-821, may stimulate the immune~     system in different ways and stop tumor cells from growing. Giving vaccine therapy together~     with OPT-821 may kill more tumor cells. It is not yet known whether giving vaccine therapy~     together with OPT-821 is more effective than OPT-821 alone in treating ovarian epithelial~     cancer, fallopian tube cancer, or primary peritoneal cancer.~      PURPOSE: This randomized phase III trial is studying vaccine therapy and OPT-821 to see how~     well they work compared with OPT-821 alone in treating patients with ovarian epithelial~     cancer, fallopian tube cancer, or primary peritoneal cancer in complete remission.~   "
218932|NCT00693329|"~     This is a multi-center clinical study designed to assess the performance of the Triage NGAL~     test as an aid in the early risk assessment for contrast-induced nephropathy (CIN).~     Approximately 260 adults at risk for CIN undergoing intra-arterial angiography involving~     administration of iodinated contrast agent(s) will be enrolled.~   "
218933|NCT00693316|"~     The purpose of this study is to evaluate the safety and tolerability of escalating doses of~     ORM-12741 in healthy volunteers.~   "
218934|NCT00693303|"~     The purpose of this study was to examine the changes in handwriting performance in elementary~     aged children who received handwriting training which included use of the My Scrivener~     stylus. Training on the My Scrivener stylus provided additional feedback to the children~     which is hypothesized to produce significant improvement.~   "
218935|NCT00693290|"~     Study hypothesis The overall aim of this study is to compare two bowel preparations that are~     used prior to a colonoscopy procedure.~      The principal research questions are:~        1. Does the use of a low residue diet increase patient concordance to the bowel preparation~          instructions?~        2. Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?~        3. Does the use of a low residue diet increase the willingness of patients to undertake~          repeated examination as is required for disease follow−up?~        4. Does body weight affect perceived tolerability of either group?~   "
218936|NCT00693277|"~     1. Research question Can a web-based nutritional educational intervention improve~          phosphorus knowledge and control of phosphorus intake?~        2. Experimental design~           Following enrollment and informed consent, subjects will be randomized to one of two~          arms (group1: usual care; group 2: usual care plus Internet-based nutrition module). All~          subjects will undergo baseline data collection, consisting of:~             1. Short form of the test of functional health literacy in adults: categorizes~               individuals as having adequate, marginal or inadequate health literacy.~             2. Chronic Kidney Disease (CKD) Knowledge Assessment Tool: addresses nutritional~               knowledge of CKD.~             3. SF-12 Health Survey version 2: a 12-item measure of health related quality of life.~             4. Kidney Disease Self-Management Survey: a 58-item Likert scale based on theories~               important for self-management in chronic disease.~             5. 3-Day Dietary Diaries~             6. Lab work:~           i. Serum phosphorus, calcium and parathyroid hormone levels. ii. Circulating endothelial~          cells, a novel marker for vascular damage.~           Following baseline data collection, group 1 will continue with their scheduled clinic~          visit, while group 2 will spend approximately 30 minutes completing a web-based~          nutrition module. After completion of the module, patients will proceed with their~          scheduled clinic visit.~           All subjects will then be asked to return in 30-60 days to repeat some of the survey~          information and blood work~        3. Major risks to subjects There is the potential for some mild discomfort from the~          necessary blood draws, which occur twice per subjects.~        4. Potential benefits to subjects Subjects randomized to the web-based module may receive~          an educational benefit from it.~        5. Consent procedures Only individuals who can provide their own consent can participate.~          Upon agreeing to enroll, a study coordinator or investigator will provide the subject~          with a copy of the consent form, and will remain available to answer any questions.~   "
218937|NCT00693264|"~     The purpose of the study is to learn about an herbal product called Hoodia gordonii. We want~     to know if Hoodia gordonii affects blood pressure, heart rate (pulse), heart pressures, and~     the heart's electrical conduction system. To participate in this study you must be a healthy~     volunteer with no known medical problems.~   "
218938|NCT00693251|"~     It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.~   "
218986|NCT00692614|"~     This study will evaluate the treatment effect of three doses of the I-vation TA implant~     (MK0140) in diabetic patients with clinically significant macular edema.~   "
218940|NCT00693225|"~     The purpose of this study was to determine the effect of morning versus bedtime~     administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients~     with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of~     Zegerid would be superior in healing esophagitis compared to morning administration prior to~     a meal.~   "
218941|NCT00693212|"~     The first phase was a double-blind crossover design of methylphenidate in the treatment of~     adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in~     adult ADHD. It was hypothesized that methylphenidate would prove more effective than placebo~     in treating ADHD symptoms during the first phase. It was also hypothesized that~     methylphenidate responders from the double-blind trial would continue to benefit from~     treatment in the second phase. Improvement would include both ADHD symptoms and social~     adjustment.~   "
218942|NCT00693199|"~     The aim of this study was to investigate the efficacy and safety of low dose amlodipine~     alone, or combined with low dose terazosin in male patients with both lower urinary tract~     symptoms and hypertension.~   "
218943|NCT00693186|"~     Primary objective:~        -  To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA~          during the first two years of life the percentage of subjects with an anti-HBs antibody~          titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10~          µg .~      Secondary objectives:~        -  Additional immunogenicity assessments~        -  Standard safety assessment.~   "
218944|NCT00693173|"~     The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with~     identical radiation treatment technique and parameters. After the two setups have been~     planned, the treating faculty reviews the setups and will choose the setup he feels that will~     give the patient improved dosimetry to the local regions and hopefully reduce toxicity and~     improve treatment tolerability.~   "
218945|NCT00693160|"~     This research study is being done because pain is a significant problem for patients with a~     variety of medical problems and following surgery or traumatic injury. Currently available~     pain medications may not treat all types of pain or may treat pain only at doses that produce~     side effects and complications. The medication in this study may have a role in better~     treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic,~     pain reliever), given into the fluid in the back near the spine has any effect on pain or~     discomfort in the skin sensation that will take place after applying capsaicin (chili pepper)~     cream. The sunburn-like sensation that people experience after having capsaicin cream applied~     is similar to, but much milder than, the pain that some people have after surgery and after~     certain types of nerve injuries. This study will test the effects of combining two~     medications that are often given together to control postoperative pain or pain from a nerve~     injury. The investigators are especially interested in answering two questions about the~     effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic~     painkiller):~        1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on~          your skin, which develops after applying capsaicin cream?~        2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?~   "
218946|NCT00693147|"~     Protocol Synopsis~        -  Protocol title: Late postoperative course of patients with mini Video Assisted~          Thyroidectomy (miVAT) versus classic Thyroidectomy (T)~        -  Purpose: Comparison of the late postoperative course and complications of the patients~          using the two techniques~        -  Design: Prospective, single-center randomized study~        -  Patient Population: Male or female subjects 18 years of age or older with nodular goiter~          who are scheduled for total thyroidectomy (miVAT or T)~        -  No. of Subjects: 100 patients divided into two groups, estimated up to 1 year to enroll~        -  Duration of Treatment: During the operation~        -  Duration of Follow-up: Follow-up will be performed by evaluation at the 3rd and 6th~          postoperative month ±5 days~        -  Endpoints: To evaluate the long term safety of each technique~   "
218947|NCT00693134|"~     Children can have or develop certain problems with their heart function, specifically with~     the heart muscle or myocardium. This problem can be caused by many things specifically by~     infection resulting in myocarditis (inflammation of the heart muscle) or dilated~     cardiomyopathy (caused by many factors including high blood pressure and heart attacks). The~     body goes through many processes to repair the injured tissue including using proteins that~     cause the muscle mass to increase called matrix metalloproteinases (MMPs). The body also uses~     proteins that direct the MMPs to stop increasing the muscle mass called tissue inhibitory of~     metalloproteinases (TIMPs). Currently, there are no published studies that explain or~     evaluate the relationship that MMPs and TIMPs have in myocarditis and dilated cardiomyopathy~     in children.~      The investigator wishes to perform a prospective study of the serum levels of these proteins~     and their regulators in children with myocarditis and/or dilated cardiomyopathy and compare~     them with children that have no heart disease.~   "
218948|NCT00693121|"~     Patients with traumatic brain injury often experience a period of acute confusion that may~     include agitation as they recover from their injuries. While this confusion generally~     resolves with time, patients may pose increased risk of injury to themselves or others during~     this period. Their behavior may also increase stress for family members and interfere with~     their ability to benefit from rehabilitation therapies. A number of different medications~     have been used to treat confusion to decrease agitation, decrease risk of injury, and improve~     participation in rehabilitation therapies. To this point, there has not been a research or~     scientific basis for knowing which medication is the best for a specific patient. The overall~     goal of this study is to conduct a scientific investigation to help determine which~     medication works best to treat confusion.~      Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute~     confusion after traumatic brain injury.~   "
218949|NCT00693108|"~     it has been shown that androgens in non human primates may favour follicular growth in the~     ovaries when animals are treated with gonadotropins which are the hormones used in patients~     receiving treatment with in vitro fertilization. Therefore, this study investigates the~     potential usefulness of testosterone treatment preceding gonadotropin administration in in~     vitro fertilization patients having a previous poor response to gonadotropins alone.~   "
218950|NCT00693095|"~     The purpose of this research study is to learn if your own immune cells can be activated and~     multiplied in order to help your body fight off the tumor cells in your brain. The safety of~     this procedure will also be studied. This procedure, called CMV-autologous lymphocyte~     transfer or CMV-ALT is investigational which means that it is not approved by the US Food and~     Drug Administration (FDA) and is still being tested in research studies. Autologous~     lymphocyte transfer or ALT means that you will receive your own immune cells back (and not~     from another donor) as a treatment after they have been activated and grown to large numbers~     in a clinical lab.~      It is believed that the body's immune (protection) system can attack tumor cells and kill~     them. Immune cells called T-lymphocytes (T-cells) can recognize special proteins on the~     surface of tumors as a signal to attack and fight the cancer. In most patients with advanced~     cancer, the immune system does not adequately destroy the tumor because the white blood cells~     or T-cells are not stimulated enough.~      Before your T-cells can become active against tumor cells, they require strong stimulation.~     There are special stimulator cells in the body called Dendritic Cells (DCs) that can take~     up proteins released from cancer cells and present pieces of these proteins to T lymphocytes~     to create this strong stimulation. Dendritic cells taken from your blood will be pulsed or~     loaded with genetic material called RNA (ribonucleic acid), which stimulates the DC to change~     the RNA into a protein called pp65. This protein is produced by a common virus called~     Cytomegalovirus (CMV) that 70-80% of us have been exposed to in our lifetime. Recently, we~     have found that this virus is present in many malignant brain tumors. Brain tumors are very~     aggressive and, for reasons we do not yet understand, are difficult for the body to attack.~     The CMV virus is a target in the tumor that, if attacked by your immune systems cells, may~     prevent your tumor from growing. We have found that we can grow immune cells to very large~     numbers from the blood of people who have evidence of prior exposure to this virus. You will~     therefore be tested to determine if you have pre-existing antibodies to this virus in order~     to participate in this study.~      We will use your DCs to activate and grow immune cells from your blood to large numbers in a~     clinical laboratory. These CMV-specific immune cells, called CMV-ALT, will be returned to~     your body when they have become activated. It is hoped that these cells will seek out and~     kill tumor cells that express the CMV viral protein and not attack normal cells. The transfer~     of immune cells that stimulates your immune system is called adoptive immunotherapy. We will~     evaluate two doses of immune cells in this study (Dose 1 and Dose 2). Depending on when you~     are enrolled in this study you will receive either Dose 1 or 2. The first six patients~     enrolled on this study will receive Dose 1 (the lower dose) and the next six patients will~     receive Dose 2 (the higher dose). We do not know at this time if either dose is more~     effective or safer to administer which is why we are testing both doses. Dose 2 will be a~     larger number of immune cells if the treatment is found to be safe in the first six patients~     treated during this study.~      In this study we will also see, in some randomly selected patients, if giving an injection of~     the DC pulsed with pp65 RNA into the skin improves the function of the CMV-ALT treatment or~     not. You will receive three injections under the skin of either some of the same DC that were~     used to stimulate your immune cells in the clinical laboratory or three injections of saline~     (salt solution) under the skin starting with the infusion of the CMV-ALT. It is unknown if a~     DC injection will be beneficial to the immune cells or not so the responses will be compared~     in patients who receive DC versus saline injection with their CMV-ALT. After these three~     injections, blood will be collected to compare the responses between patients that received~     saline to those that received DC injections.~   "
221191|NCT00663559|"~     The purpose of this trial is to determinate the efficacy of Sunitinib in patients with renal~     cells carcinoma metastasic or locally avanced in patints not candidates to inicial curative~     nefrectomy.~   "
218951|NCT00693082|"~     The overall aim of this study is to explore the effects of flaxseed supplementation and~     determine whether it is a feasible and potentially effective dietary intervention among women~     with polycystic ovarian syndrome (PCOS). Women, ages 18-45, with clinically confirmed PCOS~     (N=20) will be scheduled for baseline measures and then instructed and given supplies~     necessary to follow a flaxseed supplemented (30 g/day) diet for a period of three months,~     whereupon follow-up measures will be taken. Subjects will be asked to resume their typical~     (unsupplemented) diet for another three months and a second set of follow-up measures will be~     taken. Baseline levels of bioavailable and total testosterone, fasting insulin, glucose, and~     triglycerides (TG), total/LDL/HDL cholesterol, body weight, degree of hirsutism and acne, and~     menstrual cyclicity will be compared to levels at 3 and 6 month follow-up. The overall~     hypothesis (based upon our work in men at risk for prostate cancer and data from one~     case-study conducted in a woman with confirmed PCOS) is that during the time women receive~     flaxseed supplementation they will experience reduced serum levels of testosterone, and total~     and LDL cholesterol, as well as clinical evidence of hirsutism. Given the pilot nature of~     this study, statistical analyses will be limited to simple descriptive statistics. We have~     observed no negative side effects, other than minor gastro-intestinal occurrences (i.e.,~     temporary increased flatulence, borborygmi, increased number of stools, etc.) associated with~     flaxseed supplementation in our previous studies either with short or long-term use. Flaxseed~     supplementation will be discontinued if indicated and the events reported to the~     institutional review board.~   "
218952|NCT00693069|"~     Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces~     peri-procedural and long-term ischemic complications. Documented reduced response to~     clopidogrel has been associated with subsequent major adverse cardiovascular events.~     Strategies to optimize platelet inhibition pre-PCI are under investigation.~      This study sought to evaluate the effect on platelet aggregation of four different dosing~     regimens of clopidogrel given before elective PCI.~   "
218953|NCT00693056|"~     The primary objective of this Phase IIa trial is to determine the effective doses and~     treatment period for an upcoming RX-10100 Phase IIb trial in subjects with erectile~     dysfunction (ED). The secondary objectives of this trial are to evaluate the safety and the~     quality of life in subjects with ED receiving RX-10100 treatment.~   "
218954|NCT00693043|"~     This study will evaluate the potential to decrease the use of IV anesthesia drugs in patients~     undergoing pleuroscopy administering lidocane standardly applied to the skin in combination~     with atomized lidocaine applied into the pleural cavity.~   "
218955|NCT00693030|"~     Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the~     use of overlapping drug-eluting stents. Whether the substantial impairment of arterial~     healing observed at sites of overlap in preclinical pathologic studies persists in patients~     undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels~     requiring stents in overlap are prospectively randomized to receive multiple~     sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The~     completeness of stent struts coverage and/or late malapposition are evaluated by Optical~     Coherence Tomography at 6 months follow-up~   "
218956|NCT00693017|"~     This study is intended to provide evidence that zonisamide is safe and effective in the~     treatment of myoclonic seizures. The total planned trial duration will be 6.5 months. After~     that, subjects who have completed the study will be eligible to enroll in an open-label~     extension study until zonisamide is marketed for this indication or further development in~     this indication stops. This extension study will be described in a separate protocol~     (E2090-E044-318).~   "
218957|NCT00693004|"~     A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in~     subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment~     period and an optional 3-month extension period.~   "
218958|NCT00692991|"~     Coronary artery disease (CAD) is caused by a narrowing of the blood vessels that supply blood~     and oxygen to the heart. Balloon angioplasty and stent placement are two treatment options~     for people with reduced heart function caused by CAD. This study will use magnetic resonance~     imaging (MRI) procedures to evaluate heart function over time in people with CAD who have~     undergone a balloon angioplasty or stent placement procedure.~   "
218959|NCT00692978|"~     Asthma is most effectively treated by delivering inhaled drugs from an inhaler (puffer)~     directly into the lungs. Inhaled steroids are used in asthmatic patients to dampen down lung~     inflammation, which unchecked, can often lead to patient symptoms. Inhalers deliver a mist~     containing particles of lots of different sizes (like hairsprays). Medical puffers used by~     patients produce a 'coarse' mist of drug particles, which have the potential for side~     effects, as different sized particles will reach different parts of the airways and include;~     the mouth, the throat, the windpipe, and the bloodstream (all places we do not want the~     inhaled drug to go − and can give rise to important side effects)and, the lungs (where we do~     want the drug to 'deposit').~      Our aim in this study is to test an inhaled steroid by giving it to subjects as a 'fine' mist~     containing drug particles of nearly all one size using a research nebuliser (a Spinning Top~     Aerosol Generator). We shall use small, intermediate and large drug particle mists. We aim to~     find out how much of the drug goes to the blood stream for each particle mist and compare it~     with the standard puffers used in routine clinical practice.~      We hope this study will provide information to the rationale that by improving the efficiency~     of drug delivery (by changing drug particle size) one may improve inhaled drug delivery and~     ultimately, clinical patient benefit.~      Healthy volunteers and asthmatic patients will be recruited at the Royal Brompton Hospital~     London. The study is funded by GlaxoSmithKline, Research & Development, U.K.~   "
218960|NCT00692965|"~     The purpose of our study is to survey the quality of sleep and sleep disordered breathing in~     a HIV infected inner city ambulatory African-American Population aged 50 years and older.~      Hypothesis: African-American HIV infected individuals aged 50 years and older have a high~     prevalence of sleep disorders and lower quality of sleep.~   "
218961|NCT00692952|"~     A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to~     evaluate the efficacy, safety and acceptability of newly-developed vaginal contraceptive gel,~     the optimized benzalkonium chloride (BZK) gel containing 18mg BZK, with comparison to a~     currently marketed (in China)contraceptive gel LELEMI® containing 50mg Nonoxynol-9 (N-9).~   "
218962|NCT00692939|"~     The objective of this study is to evaluate the safety and effectiveness of administering~     high-dose chemotherapy followed by infusion of autologous CD34-selected peripheral blood stem~     cells (PBSC) in pediatric and adult patients with severe Crohn's disease.~   "
218963|NCT00692926|"~     The main purpose of this investigational (not approved by the FDA) Phase I research is to~     test whether transplantation of umbilical cord blood cells can be safely supplemented with a~     transfusion of a portion of these cells that have been sorted (collected from a special~     machine called a cell sorter) and then either infused a few hours after the standard~     transplant or for some patients grown in a special system in the laboratory prior to the~     transplant, designed to increase the number of stem cells transplanted. This system is~     currently in the early phases of testing.~   "
218964|NCT00692913|"~     A study designed to see if the study drug will increase blood levels of vitamin D, bone~     mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of~     falls as compared to women receiving standard care for osteoporosis.~   "
218965|NCT00692900|"~     The purpose of this study is to determine the safest and maximum tolerated dosing regimens~     for intraperitoneal oxaliplatin with intravenous docetaxel and intravenous oxaliplatin with~     intraperitoneal docetaxel for recurrent ovarian, primary peritoneal, or fallopian tube~     cancer.~   "
218966|NCT00692887|"~     Study come to investigate the correlation between visual fields (VF) defects map generated by~     preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions~     (CNV) demonstrated by Optical Coherence Tomography(OCT).~      To investigate the Foresee PHP ability to asses treatment progression post treatment.~   "
218967|NCT00692874|"~     This is an open label, non-interventional quality of life analysis for Zoladex treated~     prostate cancer patients by investigator's questionnaire~   "
218968|NCT00692861|"~     This study, done in collaboration with Cornell University in New York, will explore the~     potential role of the body s immune response to gluten in ataxia. Celiac disease is an~     autoimmune disorder that is triggered by the ingestion of wheat gluten and related proteins~     in genetically susceptible individuals. Some people with celiac disease also develop ataxia,~     which is a loss of muscle coordination, leading to imbalance. The cause of the associated~     ataxia is not well understood, but it is suspected to be related to the immune response~     towards gluten in these patients. Preliminary results indicate that antibodies in people with~     celiac disease can react with brain proteins, which might have a role in the associated~     neurologic deficits. The aim of this study is to characterize the immune response in the~     ataxia that is associated with celiac disease.~      People 18 years of age and older with 1) ataxia and no celiac disease, 2) ataxia plus celiac~     disease and 3) matched healthy control subjects will be enrolled at the NIH. People with~     celiac disease only will be enrolled at Cornell University.~      All participants have a blood sample drawn for various tests of immune function as well as~     genetic tests. Healthy volunteers also have a history and physical examination if they have~     not had one done at NIH in the past year. Some patients may require additional clinical~     evaluations for clinical or diagnostic reasons.~   "
218969|NCT00692848|"~     Serious bacterial infections are often difficult to detect in children with fever without~     source. Procalcitonin is a better blood marker of infection than White blood cell count and~     possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription.~     Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in~     children 1 to 36 month old with fever without source and our hypothesis is that it will lower~     the antibiotic prescription rate~   "
218970|NCT00692835|"~     Protocol Synopsis~        -  Protocol title: Immediate postoperative course of patients with mini Video Assisted~          Thyroidectomy (miVAT) versus classic Thyroidectomy (cTT)~        -  Purpose: Comparison of the immediate postoperative course and complications of the~          patients using the two techniques~        -  Design: Prospective, single-center randomized study~        -  Patient Population: Male or female subjects 18 years of age or older with nodular goiter~          who are scheduled for total thyroidectomy (miVAT or T)~        -  No. of Subjects: 100 patients divided into two groups, estimated up to 1 year to enroll~        -  Duration of Treatment: During the operation~        -  Duration of Follow-up: Follow-up will be performed daily while hospitalized, and by~          phone till the 7th postoperative day~        -  Endpoints: To evaluate the safety and cost-effectiveness of each technique~   "
218971|NCT00692822|"~     To perform a laboratory sensitivity testing survey of antibiotic agents against Neisseria~     gonorrhea isolates from men with symptomatic urethritis seen at an STD clinic.~   "
218972|NCT00692809|"~     HIV induced altered representation and function of regulatory T cell subsets (NKT and Treg~     cells) impair the protective T cell response against M.tuberculosis and disrupts LTBI, thus~     facilitates faster progression and development of severe forms of clinical TB in HIV-TB~     co-infection.~   "
218973|NCT00692796|"~     The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on~     shortness of breath, exercise capacity, symptom control, mental health, cognitive function,~     and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Pulmonary~     rehabilitation has already been shown to benefit patients with other chronic respiratory~     diseases, such as chronic obstructive pulmonary disease (COPD). We believe that pulmonary~     rehabilitation will benefit patients with IPF as well.~   "
218974|NCT00692783|"~     C. dubliniensis has been identified as pathogen in Oropharyngeal Candidiasis(OPC)particularly~     among HIV patients. Azole therapy is a cornerstone in OPC, but resistance within C.~     dubliniensis isolates to diflucan is common.This is a prospective collection of biological~     specimens from oropharyngeal cavity with the purpose of determining the prevalence of C.~     dubliniensis in HIV/AIDS patients at the Duval County Department of Health Comprehensive care~     Center. It is hereto proposed an estimation of azole-resistance in these isolates.~   "
218975|NCT00692770|"~     To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of~     Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or~     local ablation).~   "
218976|NCT00692757|"~     The purpose of this study is to determine whether hypochlorous acid is an effective~     antiseptic agent to prevent surgical site infection.~   "
219235|NCT00689351|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal~     conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.~   "
218977|NCT00692744|"~     In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH)~     increase with age. In patients older than 70 years, the occurrence of SAH exposes them to~     high risk of morbidity and a poor quality of life.~      In this age bracket, the single randomized which compared endovascular coiling to~     microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased~     after coiling. Moreover, some prospectives studies about endovascular coiling described~     favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a~     procedural complication rate in 13% to 19%. From prospectives series, the proportion of~     favorable outcome after microsurgical clipping was estimated around 66% but the procedural~     complications are few reported. The outcome for patients treated conservatively was~     catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of~     patients.~      The study hypothesis is that, in this age class, no difference exists between the 2~     obliteration procedures.~      An accurate evaluation of result in term of functional disability, quality of life and~     prognosis predictive factors seems a judicious question.~   "
218978|NCT00692731|"~     The primary objective of this trial is to evaluate the influence of consuming a tea catechin~     containing sports beverage on body fat mass during exercise-induced weight loss among~     overweight and obese men and women.~   "
218979|NCT00692718|"~     Our study is to investigate the effect of N-3 Fatty Acids for the prevention of atrial~     fibrillation in patients with acute heart failure or acute myocardial infarction~   "
218980|NCT00692705|"~     The study is carried out in order to investigate if [11C]AZD2995, compared to [11C]AZD2184,~     is a more suitable PET ligand for in vivo imaging of β amyloid depositions in the human~     brain. In the study the two PET ligands will be examined in both healthy volunteers and~     patients with Alzheimer's Disease.~   "
218981|NCT00692692|"~     We propose to evaluate the question of whether there is a significant difference between the~     traditional method of serratus flap tissue expander reconstruction and the acellular matrix~     method.~   "
218982|NCT00692666|"~     Letigen® was a combination drug containing ephedrine, an adrenergic agonist with lipolytic~     and appetite-inhibiting properties. The drug was used as adjuvant treatment of obesity from~     1990 and up to 2002 when it was withdrawn from the market by the manufacturer. The basis for~     this was a number of spontaneous reports about patients that died during treatment with~     Letigen®.~      The causal relation has never been addressed. There are only sparse data from randomised~     studies and the above-mentioned reports are not conclusive.~      We propose a controlled study based on data from Statistics Denmark that hold a complete copy~     of the Prescription Register of the Danish Medicines Agency and the Danish Hospital Discharge~     Register. The aim of the study would be to determine whether there is an excess frequency of~     deaths and serious cardiovascular events that can not be explained by particular~     characteristics of users of the drug. A well-known problem in such observational studies is a~     fundamental incomparability between users and non-users of drugs. In the present setting, it~     should be expected that use of Letigen® is associated with high BMI, smoking, alcohol abuse,~     type-2 diabetes, mild hypertension, low physical activity and other indicators of unhealthy~     lifestyle. Thus, an uncritical comparison between users and non-users of Letigen® regarding~     serious cardiovascular events will probably show an excess frequency that can not necessarily~     be attributed to the drug. This problem can be addressed by a special epidemiological~     technique - the case-crossover design - which is particularly robust to such comparability~     problems. In brief, only cases should be included. Controls are the same persons at an~     earlier time, , where the case-defining disease has not yet developed. The exposure of cases~     will be compared with the exposure of the same persons' case history.~      To account for the effect of chronic exposure, we also perform, as a secondary analysis, a~     conventional case-control study nested within the cohort of Letigen users, and employing a~     risk-set sampling technique.~   "
218983|NCT00692653|"~     The purpose of this study is to determine whether or not participation in an experimental~     program called the P4 program is useful to men who are faced with choices about treatment~     for their early stage prostate cancer. The P4 program consists of a series of questions and~     information for the participant.~      Before seeing the cancer specialist, participants will answer several questionnaires on a~     computer. This will take about 20-30 minutes. Participants may choose to do this on a~     computer at home or on a touch-screen computer in the clinic. Half the participants will then~     be shown several highly rated informational websites about prostate cancer treatments. The~     other half, based on the individual participant's answers, will receive the P4 program's~     customized written and on-screen information. Reading the information and watching videos~     will take about 20 minutes.~      About one month later, and again 6 months, participants will complete follow-up~     questionnaires electronically or by mail. These questionnaires will help us understand how~     each participant's decision for treatment of their prostate cancer went. Answering these~     questionnaires should take about 20 minutes each time.~   "
218984|NCT00692640|"~     The purpose of this study is to evaluate the safety and tolerability of XL147 in combination~     with erlotinib (Tarceva®) in subjects with solid tumors. XL147 is a new chemical entity that~     inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce~     apoptosis (programmed cell death) in tumor cells. Erlotinib is an orally administered~     inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a~     single agent for the treatment of patients with locally advanced or metastatic non-small-cell~     lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in~     combination with gemcitabine for first line treatment of patients with locally advanced,~     unresectable or metastatic pancreatic cancer.~   "
218985|NCT00692627|"~     acidosis, acute renal failure and acute pulmonary oedema are common, and frequently fatal,~     manifestations of severe P. falciparum malaria. The course of all three might be ameliorated~     by optimising a patient's intravenous fluid therapy. The fluid treatment of severe malaria is~     presently empirical, by defining cardiovascular responses to volume replacement we would~     provide a physiological basis for resuscitation strategies.~      We will use pulse contour cardiac output monitoring (PiCCOTM) to guide the fluid~     resuscitation of patients admitted to intensive care with severe malaria. With data collected~     during the patients' admission we hope to:~        1. Assess the degree of hypovolaemia in adults with severe malaria and its contribution to~          microcirculatory dysfunction and acidosis.~        2. To assess the relationships between volume status, haemodynamic parameters and the renal~          and pulmonary manifestations of severe malaria.~        3. To assess the utility of central venous pressure measurement as a guide for fluid~          administration in patients with severe malaria~        4. To investigate the prognostic and clinical utility of central venous oxygen saturation~          in severe malaria~      In this way we hope to develop a greater understanding of the pathophysiology of haemodynamic~     derangement in severe malaria. By comparing the PiCCO derived data with simpler clinical~     parameters, we hope to determine potential fluid resuscitation strategies - relevant for a~     resource poor setting - whose efficacy could be confirmed in future trials.~   "
218987|NCT00692601|"~     Capsiate is a non-pungent analogue of capsaicin, the component of hot peppers that makes them~     hot or spicy. Unlike capsaicin, capsiate is not spicy or hot. Ingestion of capsiate has been~     shown to increase resting oxygen consumption, body temperature, and the burning of fat. As~     such, capsiate appears to act in a manner similar to that of many other substances that~     energize us, increase our alertness and cause a rushing feeling by affecting a system in our~     body that is responsible for the release of adrenaline. The major difference, however, is~     that capsiate is broken down in the stomach into two components: vanilla and a fatty acid,~     and is not absorbed as capsiate into the blood stream at all. This implies that the way~     capsiate works is likely by acting on the cells in the gut (before it is broken down)rather~     than affecting all other cells in the body as it would do if it ended up in the blood.~     Therefore, the gut cells are thought to be the ones responsible for triggering the full-body~     adrenaline response. In any case, the use of capsiate has been shown to be effective in~     preventing weight gain and as such it may represent a possible therapy for treating obesity.~     Many obesity-related programs not involving medication advocate the use of diet and/or~     exercise. However, one of the biggest problems with weight loss from dieting alone is a~     general decrease in our body's ability to burn the food we eat as energy. This very problem~     is the reason for why people turn to adrenaline-releasing drugs like caffeine and ephedra.~     Unfortunately though, if too much is consumed, there is a high risk of bad side-effects.~     However, low dose caffeine/ephedra compounds (that are within specified FDA limits) have~     recently been reported to be effective. Moreover, these compounds are used with great~     frequency by people attempting to lose weight.~      Given that capsiate increases body temperature, promotes the burning of body fat and has an~     exceptionally great side-effect profile, it looks to be a very effective supplement for use~     in treatment of obesity and overweight. As such, it would be important to test this~     supplement along with exercise. This is because consuming capsiate with exercise may enhance~     its effectiveness in increasing the burning of body fat. The primary purpose of this study is~     to examine the response of young healthy males to a 90 minute bout of moderate intensity~     cycling after having consumed 0 mg, 3 mg, or 10 mg of capsiate.~   "
218988|NCT00692588|"~     Objectives:~      To study the changes in brain structure and function using MRI scans in patients treated for~     Alzheimer's disease.~      Methods:~      A pilot study of treating Alzheimer's disease with antibiotics showed some promise that this~     treatment could delay the deterioration of the mind with this disease. This study is being~     replicated on a larger scale, providing a more definitive answer to this question. In~     addition to looking at changes of the mind (through cognitive tests), we would like to use~     MRI scans in these patients before and after treatment to study the structural changes and~     the chemical changes in the brain. This would provide a non-invasive look at the bran~     processes that protect the brain from the effect of Alzheimer's as well as confirming that~     the disease has been modified with treatment.~      Impact:~      The novel treatment of Alzheimer's with antibiotics has provided a potential breakthrough in~     the field. In addition to verifying changes in the brain, MRI scans can observe HOW this~     process could occur, thus opening doors to other new treatments for Alzheimer's and perhaps~     even cures.~   "
218989|NCT00692575|"~     This study seeks to determine if problem-based telephone counseling improves quality of life~     and emotional well-being for caregivers of persons with moderate to severe traumatic brain~     injury (TBI).~   "
218990|NCT00692562|"~     The aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney~     transplantation in patients of type 1 diabetes with end-stage renal disease using a~     glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Islet~     transplantation can result in insulin independence with excellent metabolic control when~     glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet~     mass. Alemtuzumab (Campath-1H ®) is a 150-kDa humanized IgG1 monoclonal antibody that targets~     the CD52 antigen. Prolonged lymphocyte depletion can be expected following alemtuzumab~     treatment.~   "
218991|NCT00692549|"~     A randomized trial of the use of ultrasound by emergency physicians in the placement of~     intravenous catheters in emergency patients who are found to have difficult intravenous~     access (defined as two failed attempts by nursing staff).~   "
218992|NCT00692536|"~     This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD)~     with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets~     will be compared with respect effects on weight reduction, metabolic regulation, and~     long-term compliance to the diet regimes. Seventy-two postmenopausal overweight healthy women~     have been recruited and will be followed for two years.~      The following variables will be studied:~        -  Anthropometry~        -  DEXA~        -  OGTT~        -  Liver fat content measured with 1H-MRS~        -  Hepatic 11β-HSD1 activity, measured with cortisone/cortisol conversion test~   "
218993|NCT00692523|"~     This study is a pilot, randomized trial that will examine whether the Nintendo Wii virtual~     gaming system is safe and feasible for use in patients who have had a recent stroke.~   "
218994|NCT00692510|"~     The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4,~     2C8, 2B6 and UGT1A1 activity.~   "
218995|NCT00692497|"~     We want in this study to investigate the cost-effectiveness and waiting time of direct~     electronic referral and booking of outpatient surgery compared to the traditional patient~     pathway where the patient is seen at the outpatient clinic prior to surgery.~   "
218996|NCT00692484|"~     Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior~     to surgery.~   "
218997|NCT00692471|"~     We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep~     disturbances in patients with orthostatic intolerance compared with healthy control subjects.~     In this pilot study, we will test the null hypothesis (Ho) that there are no differences in~     the sleep quality between patients with orthostatic intolerance and healthy control subjects.~   "
218998|NCT00692458|"~     The purpose of this study is to test MK0822 on reducing the risk of bone metastasis in women~     with breast cancer.~   "
218999|NCT00692445|"~     This is a multi-center, double blind, randomized, placebo-controlled, parallel group,~     flexible dose titration study conducted in centers in the USA and India. Following a washout~     period, subject will be treated with citalopram 20 mg once daily for 4 weeks, then with 40 mg~     once daily for 4 weeks. Subjects who tolerate 40 mg citalopram, but whose MADRS score is <~     50% from baseline, but no lower than 17, will be considered partial or non-responders and~     will be randomized to receive either placebo or TC-5214 as add-on therapy. TC-5214 or placebo~     will be started at 2 mg daily (BID dosing), and be titrated based on tolerability and~     therapeutic response up to 8 mg daily. Approximately 560 subjects will enter the Open Label~     Phase and approximately 220 will enter the double blind phase of the study.~   "
219012|NCT00692276|"~     The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the~     safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy~     adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been~     unresponsive to conservative care.~   "
219000|NCT00692432|"~     Introduction: In recent scientific literature, 2 proteins, macrophage migration inhibitory~     factor (MIF) and high-mobility group-1 protein (HMG-1), have emerged as important mediators~     of inflammation and sepsis.~      Hypothesis: MIF and HMG-1 will be present in the serum of children who have undergone~     cardiopulmonary bypass. MIF will be present in the myocardium of children who have undergone~     cardiopulmonary bypass. The presence of MIF and HMG-1 in the serum and MIF in the myocardium~     of children undergoing bypass will correlate with clinical outcome.~      Methods: We will study a group of infants and children undergoing operative repair of~     congenital heart disease during which there is an expectation of cardiac tissue removal.~     Patients will have an assessment of cardiac function by echocardiography as well as blood~     assays for tumor necrosis factor (TNF), interleukin-6, interleukin-8, interleukin-10, MIF,~     and HMG-1 prior to surgery. Cardiac tissue, removed as a planned part of the procedure, will~     be obtained from the cardiothoracic surgeons and assayed for MIF and for apoptosis, a~     potential mechanism of myocardial dysfunction mediated by MIF and/or HMG-1. The patient will~     be admitted to the cardiac intensive care unit post operatively for routine care. Blood will~     be obtained at 1, 8, 24, 28, and 72 hours post operatively for the cytokine assays detailed~     above. The blood will be drawn from indwelling arterial or venous catheters routinely placed~     at the time of surgery. The amount of blood drawn (-4cc per sample) is unlikely to cause any~     hemodynamic compromise or result in additional blood product replacement.~      Sample size and Analysis Plan: 30 subjects will be enrolled to determine the presence or~     absence of MIF/HMG-1 in the serum and cardiac tissue pre and post cardiopulmonary bypass.~     Descriptive statistics of patient demographics and clinical outcome variables will be~     correlated to serum and myocardial concentrations of the various cytokines.~   "
219001|NCT00692419|"~     This study is seeking to identify the most effective strategy to manage pain, sexual~     dysfunction, and depression in patients receiving chronic hemodialysis therapy.~   "
219002|NCT00692406|"~     The broad objective of this proposal is to identify functional neuroanatomical correlates of~     impairments in sustained attention during smoking abstinence. We will measure changes in~     performance and regional blood oxygenation levels using fMRI while smokers and non-smokers~     complete a task designed to assess sustained attention—or the continuous monitoring of~     stimuli.~      Our primary hypothesis is that smoking abstinence will result in impaired sustained attention~     accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in regions~     associated with sustained attention including right fronto-parietal cortex, thalamus and~     reticular activation system. Abstinence may also result in performance-related increases in~     activation in brain regions associated with effortful processing including the anterior~     cingulate cortex. We also hypothesize that smokers during the satiated state will exhibit~     brain activity more similar to that of non-smokers.~      In addition to task related brain responses, we will also measure changes in absolute~     regional cerebral blood flow (rCBF) and hypothesize that abstinence will result in~     significant decreases in regions associated with arousal (e.g., reticular activation system);~     information processing (e.g., thalamus); and emotional regulation (e.g., anterior cingulate~     cortex, prefrontal cortex).~   "
219003|NCT00692393|"~     This study compares primary resection with anastomosis and Hartmann's procedure in an adult~     population with acute perforated colonic diverticulitis (Hinchey Stage III and IV) METHODS:~     The primary end point was postoperative mortality. Secondary end points included surgical and~     medical morbidity, operative time, and length of postoperative hospitalization.~   "
219004|NCT00692380|"~     Radiation therapy technology that allows increased radiation dose to the tumor while sparing~     healthy tissue will improve the balance between complications and cure.~   "
219005|NCT00692367|"~     The primary objective of this study will be to determine the effects of physical activity in~     patients during substantial surgery-induced weight loss.~      A randomized controlled physical activity intervention trial in a group of patients~     undergoing bariatric surgery for weight loss. The study will involve two sites with an active~     bariatric surgery program, which have a strong track record of bariatric surgery research.~     The study will include 160-200 subjects. Changes in the primary outcome variables will be~     determined in previous gastric bypass patients as a result of 6 months of moderate physical~     activity compared to an educational control group not engaged structured exercise.~   "
219006|NCT00692354|"~     The primary objective of this study was to determine the safety, tolerability, dose-limiting~     toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once~     daily, to patients with advanced solid tumours.~      The secondary objectives of this study were:~        -  To determine pharmacokinetic parameters for CHR-2797 when administered orally at~          increasing dose levels;~        -  To investigate the pharmacodynamic effects of CHR-2797 in blood mononuclear cells and,~          when possible, tumour cells; - To enable a preliminary assessment of anti-tumour~          activity of CHR-2797.~   "
219007|NCT00692341|"~     This study will evaluate the effects of mild and moderate impairment of hepatic function on~     the single-dose pharmacokinetics, safety and tolerability of AG-013736.~   "
219008|NCT00692328|"~     To investigate how levodopa and acupuncture affect fatigue and muscle function in people who~     suffer from Parkinson's disease. Subjects may choose to participate in levodopa or~     acupuncture part, or both. Study procedures include an exercise protocol, transcranial~     magnetic stimulation (a non-invasive type of brain stimulation that cause small muscle~     twitch), a blood draw, and personality surveys.~   "
219009|NCT00692315|"~     An open label trial was undertaken in 40 autistic children to determine whether treatment~     with metabolic precursors methylcobalamin and folinic acid would improve plasma biomarkers of~     oxidative stress and measures of core behavior using the Vineland Adaptive Behavior Scales~     (VABS). Metabolites involved in methionine and glutathione synthesis and VABS behavior scores~     were measured before and after a three month intervention period.~      The results indicated that pre-treatment metabolites in autistic children were significantly~     different from values in age-matched control children. The three month intervention resulted~     in significant increases in cysteine, cysteinylglycine, and glutathione (GSH, p < 0.001). The~     oxidized disulfide form of glutathione (GSSG) was decreased (p < 0.008) and the glutathione~     redox ratio (GSH/GSSG) was increased after treatment (p < 0.001). Although significantly~     improved, these metabolites remained below control levels after intervention (p > 0.01).~     Similarly, increases in VABS composite score and sub-scores for Socialization, Communication,~     and Daily Living Skills increased after treatment (p < 0.007) but also remained below~     standard scores.~   "
219010|NCT00692302|"~     This study will evaluate the effectiveness of an individually tailored suicide prevention~     treatment program called SAFETY in reducing suicide and suicide attempts in adolescents.~   "
219011|NCT00692289|"~     This is an open label, non-interventional quality of life analysis for Arimidex treated~     postmenopausal patients in early breast cancer by investigator's questionnaire~   "
219030|NCT00692042|"~     The primary aim for this study is to investigate the safety and tolerability of the AZD1704,~     first time in man.~   "
219013|NCT00692263|"~     Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a~     single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and~     pharmacodynamic(PD) measurements are done for the next 24 hours.~      It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is~     seen in Pk or PK of tramadol~   "
219014|NCT00692250|"~     This study is designed to assess any potential interaction between colesevelam and~     ciclosporin in healthy volunteers.~   "
219015|NCT00692237|"~     Type 2 Diabetes Mellitus (T2DM) represents a model of endothelial dysfunction, where chronic~     nitric oxide deprivation, hyperglycaemia and hyperinsulinemia and fibrogenic mediators lead~     to cardiovascular remodelling associated with diabetic cardiomyopathy and in consequence to~     secondary complications of diabetes. Specific anti-oxidative and anti-fibrotic therapies are~     not currently available. Sildenafil (Viagra) has demonstrated the capability of significantly~     improving endothelial dysfunction and cardiac fibrosis in experimental animal models.~      The purpose of the present study is performed to establish the effect of chronic high dose~     sildenafil treatment on heart performance in diabetic subjects.~   "
219016|NCT00692224|"~     The purpose of this study is to determine the effect of 10 mg of oral zinc given daily~     between days 2 and 7 of life to term or near term neonates with serum bilirubin levels of~     more than 6 mg/dL at 24 ± 6 hours of life on hyperbilirubinemia and phototherapy.~   "
219017|NCT00692211|"~     We will evaluate if we can increase colorectal cancer screening rates by directly sending~     screening tests to patients rather than waiting for them to come to clinic visits. We are~     also evaluating a new test--fecal immunochemical tests--which does not require patients to~     make dietary or medication changes. We will see if patients are more likely to complete these~     tests than the standard fecal occult blood tests.~   "
219018|NCT00692198|"~     Chronic obstructive pulmonary disease (COPD) is a serious respiratory disease in which the~     airways in the lungs are partially blocked, resulting in symptoms of chest tightness,~     coughing, and difficulty breathing. Currently, there are many available treatments for~     managing COPD symptoms and improving quality of life, including medications, lifestyle~     changes, oxygen therapy, and pulmonary rehabilitation. For people with severe COPD that is~     characterized by very low blood oxygen levels at rest, long term oxygen therapy can help to~     prolong life and promote feelings of well-being. However, the effectiveness of supplemental~     oxygen therapy for people with COPD that is characterized by only moderately low blood oxygen~     levels at rest or normal blood oxygen at rest and desaturation on exercise is not known. This~     study will evaluate the effectiveness of supplemental oxygen therapy in treating people with~     COPD who have moderately low blood oxygen levels at rest or who have normal blood oxygen~     levels at rest, but have low or very low blood oxygen levels during exercise.~   "
219019|NCT00692185|"~     This study will evaluate the effectiveness of the antipsychotic medication olanzapine in~     treating outpatients with anorexia nervosa.~   "
219020|NCT00692172|"~     An extension study to evaluate safety and tolerability of up to 3 additional courses of IM~     alefacept in patients with chronic plaque psoriasis who have been previously treated with 1~     or 2 courses of IM alefacept.~   "
219021|NCT00692159|"~     This study is being performed to evaluate the safety and tolerability of TRC102 in~     combination with Alimta. In addition to safety, this study will also evaluate~     pharmacokinetics and tumor response.~   "
219022|NCT00692146|"~     A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate~     the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms~     and heat sensitivity in healthy volunteers~   "
219023|NCT00692133|"~     Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in~     patients with schizophrenia and bipolar disorder under antipsychotic treatment~   "
219024|NCT00692120|"~     Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been~     assumed that these two forms maintain blood vitamin D equally. However, this may not be the~     case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D.~     Additionally, it will evaluate whether once per month vitamin D dosing is as effective in~     maintaining blood vitamin D levels as daily dosing.~   "
219025|NCT00692107|"~     3-D conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable~     complication rates compared to conventional radiotherapy. There are retrospective and~     preliminary prospective reports of a better local control / disease free survival (including~     PSA control) using higher tumor doses. A prospective randomised phase III study is required~     to validate these reports. The purpose of this randomized phase III study is to investigate~     and compare the tumor control and toxicity in prostate cancer patients treated to 68 Gy and~     78 Gy;~   "
219026|NCT00692094|"~     The primary focus of this five-year study will be to optimize the melatonin dosing regimen~     for synchronizing the body clocks of elderly blind individuals to the 24-hour day.~   "
219027|NCT00692081|"~     Emotional and behavioural problems as well as a lack of social competence are supposed to be~     common phenomena in adolescents with borderline intellectual functioning, consequently~     impairing their social and vocational integration. Considering the lack of evaluated group~     interventions for this population, a cognitive-behavioural training is developed and its~     effectiveness is examined in a population of students attending special vocational schools.~      77 adolescents with borderline intelligence are enrolled participated in the study. They are~     randomized either to the intervention group, who received 9 group sessions over a period of 3~     months additionally to the standard vocational training (Social Competence Training for~     Adolescents with Borderline Intelligence, SCT-ABI) or to the control group who received only~     the standard vocational training. Outcome measures at the end of the intervention and at a~     6-months follow-up assessment comprise self-reports, caregiver-reports, and behavioural~     observations of cognitive, emotional, and behavioural factors of social competence.~   "
219028|NCT00692068|"~     Residual renal function is reported to contribute to the survival and cardiovascular disease~     of peritoneal dialysis patients. Oxidative and carbonyl stress are increased in peritoneal~     dialysis patients and are associated with cardiovascular risk. The aim of this study was to~     determine the relations between residual renal function and oxidative and carbonyl stress in~     peritoneal dialysis patients.~   "
219029|NCT00692055|"~     We will evaluate the bioavailability of naproxen 375 mg in two formulations~   "
219032|NCT00692016|"~     The purpose of this study is to provide information on how well an extended release~     formulation (a medication that is released and absorbed over a longer period of time than a~     regular release formulation of the medication) of naproxen sodium is absorbed into the~     bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14~     hours).~   "
219033|NCT00692003|"~     Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study~     is intended to provide evidence that zonisamide is safe and effective in the treatment of~     primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months.~     After that subjects who have completed the study will be eligible to enrol in an open-label~     extension study until zonisamide is marketed for this indication or further development in~     this indication stops. This extension study will be described in a separate protocol~     (E2090-E044-316).~   "
219034|NCT00691990|"~     Protocol Synopsis~        -  Design: Prospective, single-center randomized study Patient Population: Male or female~          subjects 18 years of age or older who are scheduled for total thyroidectomy~        -  No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to~          enroll~        -  Duration of Treatment: During the operation~        -  Duration of Follow-up: Follow-up will be performed daily while hospitalized, and by~          phone till the 7th postoperative day~        -  Endpoints: To evaluate the safety and cost-effectiveness of each technique~   "
219035|NCT00691977|"~     The purpose of the study is to assess the safety of four different doses of radiation therapy~     followed by to surgery to remove prostate tumor.~   "
219036|NCT00691964|"~     Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque~     psoriasis~   "
219037|NCT00691951|"~     A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to~     non-smoking asthmatic patients. However, the comparative response to other currently~     prescribed medications such as combination therapy of long-acting beta agonists and ICS~     remain to be further evaluated.~      No significant differences were found between our group of subjects in regard to changes in~     asthma control pulmonary function and airway inflammation following budesonide or the~     association of budesonide with formoterol for a period of 2 months. This should be further~     explored in larger groups of subjects.~   "
219038|NCT00691938|"~     This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥~     60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid~     Leukemia.~   "
219039|NCT00691925|"~     Using Contact lens following refractive procedure to reduce pain.~   "
219040|NCT00691912|"~     Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent~     and the goals of treatment include improvement of quality of life and if possible~     prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy~     and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug~     concentrations in healthy tissue and therefore toxicities maý be reduced.~   "
219041|NCT00691899|"~     The purpose of this study is to investigate the effects of MK0822 in prolonging the time to~     first bone metastasis in men with castration-resistant prostate cancer.~   "
219042|NCT00691886|"~     To achieve safe,consistent, continuous sedation using Dexmedetomidine in advaced bronchoscopy~     procedures that may reduce the need for rapid pain sedative infusion.~   "
219043|NCT00691873|"~     In patients with at least moderate persistent allergic asthma controlled with inhaled~     steroids, omalizumab (administered per US product label), when compared to placebo, will~     provide the participants with significantly improved tolerability of specific allergen~     immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).~   "
219044|NCT00691860|"~     Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the~     lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce~     parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position.~     Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In~     the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study~     group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the~     mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity~   "
219045|NCT00691847|"~     Determine if edema plays a role in refractive surgery~   "
219046|NCT00691834|"~     The purpose of this study is to test bone marrow mononuclear cells for patients with recent~     heart attack who are at high risk of experiencing heart failure. This study drug is made of~     you own cells. Studies similar to this one have suggested that the use of cell-based transfer~     after heart attack can improve the recuperation of the heart. The purpose of this study is to~     assess whether cell transfer can improve the healing of the heart after a heart attack.~   "
219047|NCT00691821|"~     The purpose of this study is to assess the difference in the percent reduction in wound~     surface area, without surgery, of chronic pressure ulcers of the pelvic region for Negative~     Pressure Wound Therapy (NPWT) compared to the standard dressing. This study is designed to~     provide evidence regarding NPWT as compared to standard dressing regimens and compare the~     efficacy, safety, effectiveness and cost-effectiveness.~   "
219048|NCT00691808|"~     The purpose of the study is to determine the safety, tolerability, and effectiveness of 2~     dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment~     (AAMI).~   "
219062|NCT00691626|"~     The purpose of this study is to compare the effectiveness of two talk therapies for OEF/OIF~     Veterans at the Michael J. Crescenz and the West Haven VA Medical Centers. Participants will~     randomly receive one of two individual treatments intended to improve the sleep disturbance~     and nightmares of returning Veterans.~   "
219080|NCT00691392|"~     This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in~     patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background~     Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the~     patient's isolate is believed to be sensitive by history or based on drug sensitivity~     testing).~   "
219081|NCT00691379|"~     This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus~     bevacizumab as first line treatment in patients with metastatic triple negative breast~     cancer. Furthermore, the efficacy of the combination therapy will be correlated with the~     presence of circulating tumor cells (CTCs) in this population~   "
219049|NCT00691795|"~     Epidural analgesia is widely regarding as the most effective analgesic strategy for labor~     pain. Modern practice is to utilize dilute local anesthetics as a continuous infusion along~     with an opioid, e.g., our common recipe of 12 ml/hr of 0.0625% bupivacaine with 2~     micrograms/ml fentanyl, after the initial dose to maintain patient comfort until delivery.~     This dose of the infusion often provides adequate comfort without interfering with the~     mobility of the patient and her ability to effectively push during delivery. However, this~     low dose epidural infusion strategy often results in recurrence of pain after an initial pain~     free period.~      This breakthrough pain is treated by administering small boluses of analgesics via the~     epidural catheter. The pain occurring in labor is initially of visceral origin and is~     mediated by pain fibers originating from the low thoracic and upper lumbar segments of the~     spinal cord. As labor progresses to the late first phase (also known as transitional stage),~     pain sensations originating from the distension of the pelvic floor, vagina and perineum adds~     a somatic component to labor pain. This type of breakthrough pain is often difficult to~     treat.~      Although requests from patients to alleviate late stage breakthrough pain are common, no one~     knows the most effective strategy for pain management in this stage of labor. This study is~     designed to compare the efficacy of two treatments for controlling late first stage~     breakthrough pain during labor with an epidural infusion in place: clonidine-bupivacaine~     versus fentanyl-bupivacaine.~      Women who have labor epidural analgesia in place will be enrolled to be randomized if and~     when they present with breakthrough pain in the late first stage or second stage of labor (≥~     8 cm dilated). They will receive 8 ml of a solution containing 10 mg bupivacaine and 75~     micrograms of either fentanyl (an opioid or narcotic) or clonidine (an alpha-2 agonist~     known to be effective as an epidural analgesic).~      Pain relief, labor progress and outcome will be assessed to compare fentanyl versus~     clonidine.~      It is the hypothesis of this study that clonidine added to bupivacaine is a better analgesic~     than fentanyl added to bupivacaine for breakthrough pain in advanced labor.~   "
219050|NCT00691782|"~     The purpose of this research study is to better understand African American women's hair and~     hair styling practices and how these practices affect attitudes and viewpoints regarding~     exercise.~   "
219051|NCT00691769|"~     The purpose of this research study is to see if a specific protein that we are interested in~     is involved in scarring hair loss. If these proteins are involved, further genetic work may~     also better define the disease as well as future treatment options.~   "
219052|NCT00691756|"~     The purpose of this randomized trial was to determine whether renal perfusion with cold blood~     provides better protection against renal ischemia than perfusion with cold crystalloid in~     patients undergoing TAAA repair with left heart bypass.~   "
219053|NCT00691743|"~     The current epidemiological study will be undertaken in GP's and specialized private doctors.~     In total, 85 general practitioners, orthopedics, rheumatologists and cardiologist will take~     part in the study. Data will be collected for 850 patients who visit their physician for~     medical conditions that require the use of acetylsalicylic acid and/or NSAIDS. The first 10~     consecutive patients who visit their GP/orthopedic/rheumatologist/cardiologists and are~     currently receiving acetylsalicylic acid and/or NSAIDS will be included in the study.~   "
219054|NCT00691730|"~     This research study is looking at kidney and blood pressure changes in patients receiving~     bevacizumab, aflibercept, sunitinib, or cediranib for cancer. Studying samples of blood and~     urine from patients with cancer in the laboratory may help doctors learn more about changes~     that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict~     how patients will respond to treatment with an antiangiogenic drug.~   "
219055|NCT00691717|"~     The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of~     anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the~     treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or~     ocular hypertension.~   "
219056|NCT00691704|"~     The purpose of this study is to evaluate the effectiveness of induction therapy with~     lenalidomide and low dose dexamethasone followed by sequential low dose bortezomib followed~     by low dose Melphalan and Prednisone, then followed by low dose lenalidomide for multiple~     cycles in subjects with high risk Multiple Myeloma (MM). The primary objective is to evaluate~     the efficacy as measured by the progression free survival (PFS) at 2 years of low dose~     sequential therapy following four cycles of induction therapy with lenalidomide/low-dose~     dexamethasone in subjects with symptomatic high risk multiple myeloma, who have received no~     prior treatment. A total of 35 subjects were estimated to be accrued to this Phase II trial~     over a period of subjects who are still progression-free at 2 years. Two years will be as~     measured from date of registration to the trial. Progression will include disease progression~     (DP) as well as death due to any cause. Data will be analyzed and reported by the PI after 1~     and 2 years of initiation of the study. All subsequent data collected may be analyzed and~     reported in a follow-up clinical report. The PI and independent reviewers will meet to review~     the efficacy and safety data and determine a risk/benefit analysis in this subject~     population.~   "
219057|NCT00691691|"~     Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal~     cancer suffer substantial morbidity and mortality from their hepatic disease. Curative~     resection is feasible only for selected subgroups of patients. The majority of patients have~     unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been~     used in recent years with improved response and survival. However, a significant number of~     patients, at least one-third of patients with liver metastases from colorectal cancer and~     two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure~     from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization,~     cryotherapy and thermal ablation using radiofrequency have been used to treat selected~     patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary~     tract. However, most unresectable liver cancers did not fit the criteria for these~     treatments. Therefore, other regional therapeutic option like external radiation therapy may~     be considered for local control in the liver or symptom palliation~   "
219058|NCT00691678|"~     Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint~     pain/stiffness associated with aromatase inhibitors.~   "
219059|NCT00691665|"~     Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis~   "
219060|NCT00691652|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Giving clofarabine together with rituximab~     may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when~     given together with rituximab and to see how well they work in treating patients with~     relapsed B-cell non-Hodgkin lymphoma.~   "
219079|NCT00691405|"~     A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol (given~     once or twice a day) in subjects with COPD.~   "
219063|NCT00691613|"~     Rationale:~      The investigators hypothesize that EPO protects against apoptosis after acute ischemia in man~     and that it is detectable using the annexin-A5 model.~      Objective:~      Does infusion of a single dose of Epoetin Alfa, a short-acting EPO, protect against apoptosis~     in man after acute ischemia?~      Study design:~      A double blinded randomised cross-over study.~      Study population:~      12 Healthy male volunteers, between 18 and 40 years old.~      Intervention:~      All 12 volunteers will receive a single dose of EPO and placebo in a randomized order. A six~     week wash-out period is obtained in order to avoid interference of both treatments.~      Main study parameters/endpoints:~      The percentage of difference between radioactivity (quantified as counts per pixel) of the~     experimental and control thenar muscle at one and four hours after reperfusion.~   "
219064|NCT00691600|"~     The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm~     with antibiotic versus non-antibiotic treatment after incision and drainage. We will also~     compare successful rates of cure and time to healing with IV antibiotics and 23-hour~     observation unit stay versus hospitalization with IV antibiotics for abscesses greater than 5~     cm but less than 10 cm in pediatric patients.~   "
219065|NCT00691587|"~     Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy~     people, but is a significant problem for critically ill or immunocompromised individuals.~     Experts estimate that there are greater than 100,000 patients in the United States, Europe~     and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently~     represent only about 20% of the patients in the hospital who get Pseudomonas infections.~   "
219066|NCT00691574|"~     The goal of this pilot project is to determine whether melatonin levels are disordered in~     patients with Smith-Magenis Syndrome (SMS) and whether melatonin treatment can correct~     abnormal circadian rhythms in SMS patients. In addition, the study investigates the effects~     of bright light in an elderly control population that exhibits low melatonin secretion.~   "
219067|NCT00691561|"~     The purpose of this study to conduct a small randomized control trial to compare the relative~     effectiveness of a single-session of HIV testing and counseling risk reduction intervention~     (HCT-only) to an enhanced intervention that includes the standard HCT intervention plus a~     theory-based and culturally-tailored group-level intervention designed to reduce or eliminate~     HIV and STI risk behaviors (HCT-plus) among African-American men who have sex with men~     (AA-MSM).~   "
219068|NCT00691548|"~     Non invasive imaging of cetuximab uptake with PET could help to select the patients who could~     be treated by cetuximab, a registered but expensive monoclonal antibody against EGFR. Other~     monoclonal antibodies labelled with Zirconium-89 have already been used with success in~     patients. The combination of cetuximab labelled with Zirconium-89 is a promising new probe to~     determine cetuximab uptake, which has been tested in various pre-clinical animal models in~     Maastricht with excellent results.~      We propose a two step study design (see figure 1). As our ultimate goal for the future is to~     determine the uptake of 89Zr-cetuximab in the tumour before and during therapy, we need to~     investigate the toxicity of two consecutive low doses of 89Zr-cetuximab in the first place.~     However, as in future studies and in some patients, it is also possible that a single, larger~     dose of 89Zr-cetuximab is needed to obtain the best image quality, we will also investigate~     the toxicity of a single larger dose.~      Step 1: Determination of the toxicity of two low doses of 89Zr-cetuximab In three patients a~     standard loading dose of 400 mg/m2 of cetuximab will be administered, partly labelled with~     89Zr (60 MBq, 2.5mg) on day 0.~      On day 14, a second injection with dose of 250 mg/m2 of cetuximab, partly labelled with 89Zr~     (60 MBq, 2.5mg), will be given.~      Step 2: Determination of the toxicity of one larger dose of 89Zr-cetuximab A standard loading~     dose of 400 mg/m2 of cetuximab will be administered in 3 patients, a part labelled with 89Zr~     (120MBq, 5mg).~   "
219069|NCT00691535|"~     We hope to learn more about the biology of psychiatric illness with the hope of improving the~     diagnosis and treatment of such psychiatric conditions as major depression.~   "
219070|NCT00691522|"~     This is a phase II, multicenter, open-label, imaging study of hCRF in the reduction of PBE in~     patients with primary malignant or metastatic brain tumors. Approximately 30 to 60 patients~     will be assigned to 1 of 3 treatment groups and receive study drug for up to 28 days~   "
219071|NCT00691509|"~     RATIONALE: Eating a diet rich in phytoestrogens may slow the growth of breast cancer cells~     and prevent further tumor progression. Learning about the lifestyles of women with breast~     cancer, their intake of phytoestrogens derived from food and supplements, and their use of~     complementary or alternative medicine (CAM) practices may help doctors learn more about~     breast cancer.~      PURPOSE: This clinical trial is studying the effect of dietary and supplemental~     phytoestrogens and CAM therapies in preventing progression and improving survival of women~     with breast cancer.~   "
219072|NCT00691496|"~     The purpose of this project is to test the efficacy of an HIV prevention behavioral~     intervention to reduce sexual risk among African-American men who have sex with men (MSM).~   "
219073|NCT00691483|"~     The hypothesis is that varenicline will be effective (compared with placebo) for smoking~     cessation when subjects are allowed to set their own quit date within the first 5 weeks of~     treatment.~   "
219074|NCT00691470|"~     The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The~     study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in~     the desired therapeutic range. Patients who require chronic anticoagulation with one or more~     of the following conditions are eligible for the study: atrial fibrillation or atrial~     flutter, prosthetic heart valve, venous thromboembolic disease, or history of myocardial~     infarction or cardiomyopathy will be enrolled.~   "
219075|NCT00691457|"~     Three arm study comparing three novel contact lens solutions.~   "
219076|NCT00691444|"~     The primary focus of this five-year study will be to optimize the melatonin dosing regimen~     for synchronizing the body clocks of blind children to the 24-hour day.~   "
219077|NCT00691431|"~     This study compared the clinical outcomes between fellow eyes randomized to either IntraLase~     femtosecond laser-created flaps or Hansatome mechanical keratome-created flaps during~     wavefront-guided laser in situ keratomileusis.~   "
219078|NCT00691418|"~     This is a feasibility study to determine if it will be possible to conduct a larger study of~     the effect of docosahexaenoic acid (DHA), an omega fatty acid, on increased length of~     gestation among women who have had a previous preterm delivery.~   "
219083|NCT00691353|"~     Cross - Sectional study requiring one visit at the investigators office for the data~     collection.~        -  Target Group: Patients that suffer from Bipolar Disorder Type 1.~        -  YMRS - HAMILTON and GAF scales are going to be used to assess the clinical outcome. The~          findings are going to be based on the different scores reported by Specialists (before~          the patients started to use as a therapy atypical antipsychotics / at the time that the~          visit actually takes place for the cause of the study.) We predefine the time period~          that the patient should be using atypical antipsychotics at minimum (2 months).~        -  The first 9 consecutive patients that visit the Specialist and meet the entry criteria~          and signs the ICF will be recruited in the study.~   "
219084|NCT00691340|"~     Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy~     is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the~     final end point in blinding diseases of the optic nerve such as glaucoma. It is known that~     neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies the~     investigators could demonstrate that the process of apoptosis is reflected in circulating~     leukocytes by different parameters, like differential mRNA expression and an increased~     fragmentation of the DNA. Such alterations point out a relationship between cellular stress~     and apoptotic events.~      Based on the results of mRNA-expression the investigators also expect alterations on the~     protein level.~      This study is, therefore, designed to characterize the proteome related to the proteins~     involved in cell death related pathways.~      Thus, the expression pattern of several proteins in leukocytes from patients with primary~     open angle glaucoma will be analyzed by techniques like Western-blot and tandem mass~     spectrometry. These samples will be compared with samples from healthy controls. In addition,~     they will also be compared with samples from patients with Alzheimer's disease. Since~     glaucoma is a neurodegenerative disease, these patients will be included as positive controls~     in this study.~   "
219085|NCT00691327|"~     Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women~     undergoing primary reconstruction or revision of existing breast implants.~   "
219086|NCT00691314|"~     The purpose of this study is to evaluate the efficacy and safety of stent implantation in~     patients with symptomatic extra- and intracranial artery stenosis and to determine its role~     in secondary prevention of ischemic stroke.~   "
219087|NCT00691301|"~     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving pemetrexed together with cisplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving pemetrexed together with~     cisplatin and to see how well it works in treating patients with advanced, persistent, or~     recurrent cervical cancer.~   "
219088|NCT00691288|"~     The overall objective of this study is to evaluate the safety and efficacy of fish oil~     omega-3-fatty acid supplementation in treating pediatric HAART-associated~     hypertriglyceridemia.~   "
219089|NCT00691275|"~     Dehydration due to vomiting is a common complication of acute gastroenteritis in children.~     Persistent vomiting following rehydration is a problem in outpatient management using oral~     rehydration therapy.~      Four previous studies have examined the role of the medication, ondansetron, in treating~     nausea and vomiting in children with gastroenteritis and have suggested that it may be~     beneficial [1-4]. A previous study has also shown that the administration of intravenous~     fluid alone to children with dehydration due to gastroenteritis helps resolve nausea and~     vomiting in the majority of patients [5]. None of the previous studies compared the efficacy~     of intravenous ondansetron with that of intravenous fluid alone in the prevention of vomiting~     . In addition, the previous studies were limited by poorly defined inclusion criteria and~     outcome measures.~      The proposed study seeks to more clearly define the role of intravenous ondansetron in the~     management of children suffering dehydration due to acute gastroenteritis. If ondansetron~     further reduces the incidence of vomiting compared with intravenous fluid alone, more~     children with dehydration due to acute gastroenteritis may be successfully discharged to home~     from the emergency department instead of admitted to the hospital. If it does not, the~     widespread use of ondansetron for such patients could be discouraged and money could be~     saved.~      Hypothesis:~      Patients receiving ondansetron in addition to intravenous fluids for the treatment of~     dehydration due to vomiting caused by gastroenteritis will not have a significant reduction~     in the occurrence of persistent vomiting as compared to those who receive only intravenous~     fluids.~   "
219090|NCT00691262|"~     Objective of this study is to further assess the response to treatment and safety of 0.03%~     tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to~     severe atopic dermatitis, known to be responsive to topical steroids.~   "
219091|NCT00691249|"~     This study will test the effects of resistant starch type 4 on blood sugar and hunger in~     adults with Type 2 diabetes.~   "
219092|NCT00691236|"~     This trial will be a pilot study to find out if zoledronic acid improves the response to~     chemotherapy in high grade osteosarcoma. In arm A of the study, 40 adult patients will be~     randomised into two groups. One group will get standard chemotherapy and the other group will~     get Zoledronic acid in addition to chemotherapy. The investigators will assess the~     histological necrosis as well as disease status for up to 2 years.~      In Arm B, adult patients with relapsed disease or advanced disease who are unable to take any~     other therapy and are given only symptomatic care will be given 6 doses of zoledronic acid~     and followed up for disease status. This will be to determine the role of zoledronic acid as~     a single agent.~   "
219093|NCT00691223|"~     Focal dermal hypoplasia, or Goltz syndrome, results from genetic changes, or mutations in the~     PORCN gene located on the X chromosome. This neurodevelopmental disorder is characterized by~     birth defects of the skin, skeleton, eyes, and in some cases other organs. Our team is~     working to obtain a better understanding of how mutations in PORCN lead to the clinical~     features of Goltz syndrome. We are also trying to identify the genetic change in those~     patients where no mutations in PORCN have been found. We are also investigating conditions~     with phenotypes similar to Goltz syndrome to determine if they also have mutations in PORCN.~     We are collecting blood samples from patients and their parents. DNA from these samples is~     isolated and then used for genetic testing. We also review medical records to compare~     clinical symptoms with the detected mutations to determine if there is a correlation.~   "
219094|NCT00691210|"~     The purpose of this study is to test the safety of a combination of two anticancer medicines,~     called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These~     medications will be tested at different dose levels. The investigators want to find out what~     effects, good and/or bad, it has on patients and their recurrent lymphoma. The first two~     drugs, vorinostat and niacinamide, suppress survival signals that lymphoma cells depend on.~     The third drug, etoposide can kill sensitive lymphoma cells alone or in combination with~     other chemotherapy drugs. Vorinostat is an anticancer agent that been approved by the Food~     and Drug Administration for use in cutaneous T-cell lymphoma. It is being evaluated in this~     study in combination with other anticancer medicines for use in other types of lymphoma.~     Vorinostat's use in combination with anticancer regimens is experimental. Niacinamide is a~     vitamin that is investigational or experimental when given at high doses as an anticancer~     agent. Niacinamide has not yet been approved by the Food and Drug Administration for use in~     lymphoma. Etoposide has been approved by the Food and Drug Administration for use in~     aggressive non-Hodgkin's lymphoma. However, the way it will be given in this clinical study~     is experimental.~   "
219095|NCT00691197|"~     Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses~   "
219096|NCT00691184|"~     In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl)~     nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream~   "
219097|NCT00691171|"~     The purpose of the study is to examine the impact of augmented, high-quality~     physician-coordinated care executed via an electronic health record (EHR)-based intervention~     on quality of care for gastroesophageal reflux disease (GERD) and for gastroprotection for~     patients on chronic non-steroidal anti-inflammatory drugs (NSAIDs) at increased risk for~     upper GI tract ulcers and ulcer related complications.~   "
219098|NCT00691158|"~     The purpose of this study is to identify how certain parts of the brain that help control~     body weight respond to an infusion of hormones called leptin and amylin.~   "
219099|NCT00691145|"~     The objective of this study is to assess the efficacy and safety of 0.1% and 0.03% Tacrolimus~     ointment for 12 months in adults with moderate to severe atopic dermatitis.~   "
219100|NCT00691132|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of phenethyl isothiocyanate may prevent lung cancer in people who smoke cigarettes.~      PURPOSE: This randomized clinical trial is studying phenethyl isothiocyanate to see how well~     it works in preventing lung cancer in smokers.~   "
219101|NCT00691119|"~     The purpose of this study is to find out if it is possible to study relaxation and~     visualization therapy (RVT) with individuals that have breast cancer. We will also look at~     what effects, the good and bad, RVT has when used with radiation therapy. We are interested~     in how RVT may relate to energy, quality of life, stress, and the immune system. Relaxation~     and Visualization therapy will lead participants through a practice of physical relaxation~     and then a step by step visualization. In this study, participants will be led through an RVT~     exercise, providing an interactive process. In addition, women will perform solitary RVT~     exercises at home on weekends. Participants for this study will be drawn from two OHSU~     physicians' regular patient base. To be sure that we are testing the effects of RVT alone, we~     will use three groups. The three groups will be RVT, education, and a control. The RVT group~     will receive RVT with radiation, and the education group will receive breast cancer related~     health education with radiation. The third group will receive no treatment beyond radiation.~     This third group is called the control. The entire study will last for approximately twelve~     weeks. For the first 6 weeks, each participant will be receiving radiation therapy. We will~     be particularly interested in the effects that RVT may have on energy, quality of life,~     stress, and the immune system. No experimental drug or device will be used during the study.~   "
219102|NCT00691093|"~     This is a observational study in patients treated with fesoterodine (Toviaz), who have failed~     on previous treatment for overactive bladder. It will collect epidemiological data and~     investigate the efficacy and tolerability of fesoterodine.~   "
219103|NCT00691080|"~     The investigators will examine whether sleep problems in children with autism spectrum~     disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that~     plays an important role in regulating sleep-wake cycle. Children with ASD experience high~     rates of sleep disturbances that potentially contribute to problems with thinking and~     behavior. It is unclear if changes in MT production cause sleep problems in children with~     ASD. MT is frequently used to treat these sleep problems; however, it has not been well~     established whether MT is an effective treatment. Our hypotheses concerning MT is children~     with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT~     production. This study will compare children diagnosed with ASD to healthy control children~     with no ASD diagnosis. All subjects will be recruited from one of three sites: Baylor College~     of Medicine, Oregon Health & Science University and Columbia University. The investigators~     will use a standardized questionnaire to determine whether the child has sleep problems. The~     investigators will measure MT levels in saliva in ASD children with sleep problems and in a~     group of control children without sleep problems. Total 24-hour MT production will be~     determined from urine samples in these same two groups.~   "
219104|NCT00691067|"~     We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist~     mifepristone in Gulf War veterans (GWV) with chronic multisymptom illness (CMI) to examine~     its effects on physical and mental health and cognitive functioning. In addition, we propose~     to examine whether HPA axis biomarkers or their response to mifepristone are useful~     predictors of clinical response.~   "
219105|NCT00691054|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle~     formulation works in treating patients with locally advanced or metastatic pancreatic cancer~     that did not respond to first-line therapy with gemcitabine.~   "
219236|NCT00689338|"~     To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal~     infections in intensive care and critical care unit patients.~   "
219237|NCT00689325|"~     To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with~     atypical antipsychotics.~   "
219106|NCT00691041|"~     The purpose of the study is to examine the efficacy of a network-oriented outreach~     intervention to reduce HIV and sexually transmitted infection (STI) related risk behaviors~     among African American men who have sex with men (AA MSM)and their social network. The~     hypothesis is to determine whether the new intervention is more efficacious at reducing high~     risk sexual behaviors than the standard normal of care provided to the public (a single~     session of individual HIV counseling and testing.~   "
219107|NCT00691028|"~     The purpose of this study is to assess the efficacy, safety and pharmacokinetics of~     maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with~     methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis~     (RA) showing an insufficient response to MTX.~   "
219108|NCT00691015|"~     RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy~     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.~     It may also stop the patient's immune system from rejecting the donor's stem cells. The~     donated stem cells may replace the patient's immune cells and help destroy any remaining~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus,~     and antithymocyte globulin before and after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with~     tacrolimus and antithymocyte globulin and to see how well it works in preventing~     graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem~     cell transplant.~   "
219109|NCT00691002|"~     There are few therapies suitable for the treatment of psoriasis on the face and skin folds.~     As these areas are sensitive, irritation and other adverse reactions are more common than~     elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once~     daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus~     hydrocortisone 10 mg/g with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10~     mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis~     vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the~     safety and efficacy will be evaluated for up to 60 weeks treatment as required of~     calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face~     and intertriginous areas (= open-label phase).~   "
219110|NCT00690989|"~     This is a retrospective review of the records of patients seen at the Kilgo Headache Clinic~     in Alabama between 7/1/05 and 6/30/07. The goal of the study is to identify factors at the~     time of the initial office visit that can be used to predict failure to follow-up.~   "
219111|NCT00690976|"~     The purpose of this project is to determine the acceptability, feasibility, and the~     preliminary efficacy of an HIV prevention behavioral intervention (Proyecto SOL) to reduce~     behaviors associated with HIV acquisition among Hispanic men who have sex with men (HMSM).~     The primary goal of the intervention is to motivate and assist participants in forming and~     carrying out a Safer Options for Life plan, thereby reducing their risk of HIV acquisition~     or transmission.~   "
219112|NCT00690963|"~     Patients who have inoperable non-small cell lung cancer are presently treated with~     chemotherapy and radiation therapy. Despite this combined approach, the vast majority of~     patients will have their cancer recur after treatment. A recurrence is not curable at this~     time. Because of the sensitivity of surrounding structures to chest irradiation, it has not~     been possible to give radiation doses that can cure many of these tumors. Intensity-modulated~     radiation therapy is a special form of radiotherapy delivery that allows doctors to reduce~     the amount of radiation dose to normal tissues and therefore reduce side effects. The~     reduction of radiation side effects may allow more radiation to be delivered to tumors,~     therefore improving tumor control and possibly longevity of patients. The purpose of this~     study is to determine whether the combination of custom designed intensity-modulated~     radiotherapy (based on individual tumor anatomy) with regular chemotherapy, will be safe~     enough to allow further intensification of radiation treatment.~   "
219113|NCT00690950|"~     Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume,~     improving symptoms based on International Prostate Symptom score,and lower pvr based on the~     scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs.~     finasteride which only inhibits the Type II enzyme~   "
219114|NCT00690937|"~     A total of 120 patients will be entered in this study to assess the safety and efficacy of~     enteric coated sevelamer (ECS) to lower LDL cholesterol. Patients will be randomized into two~     active treatment groups, two placebo groups and one active control group.~   "
219115|NCT00690924|"~     RATIONALE: Calcitriol may prevent lung cancer in patients with metaplasia or dysplasia of the~     lungs.~      PURPOSE: This clinical trial is studying the side effects and best dose of calcitriol in~     preventing lung cancer in current smokers and former smokers at high risk of lung cancer.~   "
219116|NCT00690911|"~     The purpose of the study is to see if Humira is effective and safe in the treatment of~     sarcoidosis.~   "
219117|NCT00690898|"~     Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and~     mainly due to benign tumour localized in the pituitary gland.~      The disease develops insidiously, causing a gradual progression of symptoms; consequently~     most patients are diagnosed in their fourth decade of life.~      Administration of somatostatin analogues such as lanreotide have been shown to result in~     normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement~     of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate~     whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the~     benefits of this potential tumour shrinkage on disease symptoms and patient's quality of~     life.~   "
219118|NCT00690885|"~     The purpose of this study is to determine whether lozenges containing interferon-alpha can~     reduce the frequency and severity of coughing in patients with chronic obstructive pulmonary~     disease (COPD) and idiopathic pulmonary fibrosis (IPF).~   "
219238|NCT00689312|"~     The primary objective of this study is to compare the mean taste scores for three fruit~     flavored oral rehydration solutions in children aged 5-10 years old. The secondary objective~     is to compare the proportions of children who indicate a taste preference for one of the~     solutions.~   "
219239|NCT00689299|"~     The purpose of this study is to identify an effective dose of allergen-specific immunotherapy~     for cat hair (Felis domesticus) administered by the oral/sublingual route.~   "
219119|NCT00690872|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving an infusion of a person's T lymphocytes that have been treated in the~     laboratory may help the body build an effective immune response to kill tumor cells. Giving~     combination chemotherapy together with laboratory-treated T lymphocytes may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine and carboplatin together~     with laboratory-treated T lymphocytes works in treating patients with metastatic or locally~     recurrent Epstein-Barr virus-positive nasopharyngeal cancer.~   "
219120|NCT00690859|"~     Observational, prospective (1 year follow up), multicenter, non-interventional open label~     study in order to assess the factors that predict onset of mood disorders episodes~     (depression, mania, hypomania and mixed) in stabilized patients with bipolar disorder I or II~     in Spain. Other objectives are~        1. to describe the clinical course of illness in a cohort of patients with TB I or II:~          duration, severity, polarity and seasonality~        2. to describe clinical and functional situation of patients during the different phases,~          evaluating prognostic meaning of subsyndromal symptoms~        3. to evaluate the economical impact on health service of these patients (hospitalization,~          primary care, treatments…).~      Target population is ambulatory bipolar I and II patients, clinically stabilized for at least~     the two months prior to recruitment and who had at least one acute episode (depressive,~     manic, hypomanic or mixed) within the year prior to recruitment. The primary endpoint is the~     onset of mood disorders episodes (depression, mania, hypomania and mixed) during the~     follow-up period and evaluation of which factors predict onset of mood episodes~   "
219121|NCT00690846|"~     The purpose of this research study is to see if Humira (adalimumab) is effective and safe in~     the treatment of pyoderma gangrenosum.~   "
219122|NCT00690833|"~     The purpose of this research study is to better understand how this study drug works when~     people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug~     Administration (FDA) for atopic dermatitis.~   "
219123|NCT00690820|"~     This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat~     and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to~     Cystic Fibrosis.~   "
219124|NCT00690807|"~     PH-10 is a formulation of rose bengal disodium (RB) for topical administration to the skin.~     PH-10 is capable of undergoing photochemical reactions when activated by ambient light. This~     phase 2 study will assess whether topical PH-10 applied once daily to mild, moderate or~     severe areas of atopic dermatitis (including atopic eczema) may ameliorate inflammation of~     the skin when activated by ambient light.~   "
219125|NCT00690794|"~     The purpose of the study is to compare two ophthalmic solutions in patients with open-angle~     glaucoma or ocular hypertension.~   "
219126|NCT00690781|"~     The purpose of this study is to minimize the loss of lean body mass that occurs during a~     weight-loss program in obese people by changing the nature of ingested protein and the~     pattern of protein feeding~   "
219127|NCT00690768|"~     The purpose of this study is to compare the amount of intraoperative intraocular bleeding~     during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD)~     with and without preoperative intravitreal bevacizumab treatment.~   "
219128|NCT00690755|"~     The investigators are examining the activation of insulin signaling factors in skeletal~     muscles of human diabetics. The investigators are characterizing the defects in signaling,~     and are examining the effects of anti-diabetic agents and exercise on signaling to glucose~     transport biochemical machinery and whole body glucose disposal.~   "
219129|NCT00690729|"~     This 16-week program examines cognitive behavioral bibliotherapy to typical~     therapist-directed cognitive behavior therapy for children and adolescents with Obsessive~     Compulsive Disorder.~   "
219130|NCT00690716|"~     The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the~     treatment of mild headaches in people who have migraines.~   "
219131|NCT00690703|"~     The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective~     treatment for malignant lung tumors.~   "
219132|NCT00690690|"~     The overall goal of this study is to develop and evaluate a brief, video-based, group-level~     intervention designed to reduce sexual risk taking among culturally diverse English- and~     Spanish-speaking Latino men who have sex with men (MSM).~   "
219133|NCT00690677|"~     The purpose of this study is to determine the effects of the study drug, LBH589, on patients~     with metastatic colorectal cancer that has continued to grow despite previous treatment.~   "
219134|NCT00690664|"~     The purpose of this research study is to better understand African American hair and scalp,~     its biologic appearance and how this relates to African Americans' perceptions of their hair~     and scalp health. Since most hair studies have looked at Caucasian hair and scalp, we will~     use a population of Caucasian subjects for comparison in evaluating various hair and scalp~     parameters.~   "
219135|NCT00690651|"~     After a patient has fractured an ankle that then requires surgery, the recommendation is to~     remain in bed, with the operated leg elevated on pillows for 48 hours. This is a~     precautionary measure, as yet unsubstantiated by research, which is thought to minimize ankle~     swelling that can inhibit the healing of the surgical wound. However, prolonged bed rest can~     lead to other complications such as blood clots in the lungs or leg veins, or chest~     infections such as pneumonia. Prolonged bed rest is also known to cause weakness and a loss~     of fitness such that recovery may be slower. In this research the investigators will be~     randomly allocating patients to mobilize within 24 hours post operatively or to rest in bed~     for 48 hours with their leg well elevated. The investigators will measure length of stay and~     wound healing and integrity at 14 days. This study aims to investigate whether getting~     patients out of bed within 24 hours of surgery can accelerate recovery and reduce acute~     hospital length of stay without affecting wound healing. If bed rest for 2 days is not~     necessary, there will be benefits for the patient in terms of general health and ability, and~     for the hospital in terms of cost savings through shorter lengths of stay and patient through~     put. The investigators already know that early mobilization is beneficial following other~     types of orthopedic surgery such as hip fractures. This study aims to investigate if early~     mobilization following surgical management of ankle fractures is safe with specific regard to~     wound integrity and wound outcomes. This study will also investigate the effect of earlier~     mobilization on the length of time spent in the acute hospital and for those discharged~     directly home, the amount and type of support required. If early mobilization is found to be~     safe for wound healing and results in shorter in-hospital stays, this research will provide~     the confidence to endorse a change to current clinical practice.~   "
219136|NCT00690638|"~     A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate~     Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus~   "
234612|NCT00485004|"~     To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent~     implantation with sirolimus-eluting implantation versus cutting balloon angioplasty~   "
219137|NCT00690625|"~     This study is designed to evaluate the effectiveness of topical application of omega-3 fatty~     acids (6% by volume) containing cream on persons with a TMD disorder, specifically with a~     diagnosis of Myofacial Pain. Omega-3 fatty acids have minimal side effects when applied~     topically. If Omega-3 fatty acids used in this study are shown to reduce myofacial pain then~     this formulation could potentially be used for treatment of TMD patents with myofacial pain~     in the future. Omega-3 fatty acids are natural ingredients with almost no side effects.~     Topical application can lead to fewer side effects than systemic medications. In addition,~     there is no substantial morbidity & mortality associated with topical application of Omega-3~     fatty acids. It is hypothesized that subjects receiving topical application of omega-3 fatty~     acids will demonstrate reduced subjective masseter muscle pain in comparison to subjects~     receiving placebo cream. This is a pilot study to assess the topical application of Omega-3~     fatty acids on muscle pain in the muscles of mastication.~   "
219138|NCT00690612|"~     The HIP study is designed to follow the clinical experience of young hypertensive children~     receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11~     years old. The study is open label with no concurrent control group. To be eligible for HIP,~     children must have completed Study 328 without discontinuation due to a study drug-related AE~     and in the investigator's opinion, have an on-going clinical indication for an orally~     administered suspension of candesartan cilexetil to control blood pressure. Children will~     return to clinic every 3 months (more frequently at the investigator's discretion) for safety~     and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses,~     echocardiograms and by physical examinations at specified clinic visits. Blood pressure and~     heart rate will be measured at each clinic visit. Study drug is administered orally once a~     day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a~     vist-by-vist basis depending on the child's BP response. It is anticipated that study dose~     will align closely with the effective anti-hypertensive dose determined in Study 328. If the~     child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day~     and/or the addition of other antihypertensive medications are permitted, with the exception~     of other angiotensin receptor blockers. The HIP study offers eligible children up to two~     additional years of treatment with the liquid formulation of Atacand.~   "
219139|NCT00690599|"~     The aim of the study was to evaluate the socioeconomic patient's profile and their level of~     satisfaction in the general dental practice clinic. A cross-sectional quantitative study was~     accomplished with 80 patients assisted at the referred service. A solely-applied~     questionnaire was used regarding the following aspects: structure and environment, fear and~     anxiety, reliability, empathy and commitment, resolutivity and quality of the accomplished~     services. It was observed that the assisted patients' profile consisted predominantly of a~     female sample (71,2%), that completed the medium learning (31,2%) and/or that didn't finish~     the fundamental level (26,2%). Moreover 50% of them presented a family income of 1 to 2~     minimum salaries and 41,2% were unemployed. As the quality of the rendered technical service,~     nearly 70% of the users considered it great, as well as the clinic's structure and~     environment. Regarding the satisfaction with to the received treatment, 76,2% of the~     interviewees gave the maximum score of 10 and 95% would recommend the attendance to others.~     It is concluded that the patients are satisfied with the clinical attendance accomplished by~     the students in the general practice dental clinic at UNIFOR, in what refers to its technical~     and functional quality.~   "
219140|NCT00690586|"~     The purpose of this study is to describe the hormones controlling fluid balance in pediatric~     patients with nephrotic syndrome. Further more, an analysis of the urinary and plasma~     proteins will be done using proteomics. Different composition of proteins in the urine or~     plasma might indicate if the patients will respond to treatment or not.~   "
219141|NCT00690573|"~     To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with~     Polyarticular Juvenile Rheumatoid Arthritis~   "
219142|NCT00690560|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and~     cyclophosphamide, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may~     be effective in treating cancer and blocking the body's immune response. Monoclonal~     antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Giving~     chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer~     cells.~      PURPOSE: This phase II trial is studying how well giving doxorubicin together with~     vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y~     90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell~     lymphoma.~   "
219143|NCT00690547|"~     Force enhancement (FE) describes the phenomenon of strength potentialization of a muscle cell~     or the complete muscle during and after active extension compared to the strength of an~     isometric contraction with same muscle length. The underlying physiological mechanism of this~     phenomenon is not completely known today. In vitro trials indicate that the interaction of an~     active and a passive component on the cellular level are responsible for the higher strength~     measurements. So far FE could be shown in vitro and in vivo on muscle fibers and small human~     muscles. Further research is needed for verification of the existence of FE in voluntary~     motor activity in everyday life. In order to approach this objective the investigators will~     scrutinize the functionality of the deliberately activated musculus (m) quadriceps femoris~     during and after active extension on the basis of in vivo studies.~   "
219144|NCT00690534|"~     Muscle loss with aging is a significant contributor to disability in older people. Our~     general hypothesis is that loss of muscle with aging, known as sarcopenia, may be due to~     inability of muscle to grow in response to insulin. Our goal is to determine the mechanisms~     underlying this age-related insulin resistance of muscle proteins, which will allow us to~     define in the future specific interventions to target this defect and provide the scientific~     basis for the prevention and treatment of sarcopenia.~   "
219265|NCT00688961|"~     Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can~     affect blood clotting by altering the function of the blood platelets. Aspirin can do the~     same. The purpose of this study is to determine the individual and combined effects of these~     two agents on platelet function using a whole blood method.~   "
219145|NCT00690521|"~     The purpose of this research study is to compare the effectiveness of hydrochlorothiazide or~     metolazone in combination with furosemide. Patients with heart failure suffer from swelling~     because of too much fluid in the body. Furosemide, hydrochlorothiazide, and metolazone are~     all water pills used to treat the swelling. For most patients, taking furosemide alone is~     successful. However, sometimes patients need to add another water pill. Doctors usually add~     either metolazone or hydrochlorothiazide. It is not clear which water pill is better when~     added to furosemide. The purpose of this study is to determine which water pill when added to~     furosemide is the best at reducing excess fluid in the body.~   "
219146|NCT00690508|"~     Background:~      The intra-tracheal intubation of a patient is a most delicate medical procedure performed~     under often life-threatening conditions in in- and out-of-hospital acute care medicine.~     Correct placement of the tube after intra-tracheal intubation is thus absolutely vital.~     Incorrect position of the tube can be fatal through loss of the airway or through barotrauma~     of the airway and lungs possibly leading to cardiac arrest. The mid-tracheal point of the~     trachea is the perfect place for an intra-tracheal tube to be to guarantee ventilatory~     support without problems for neonates and children. Supra-sternal palpation of the tube tip~     (SSTTP) is a method validated in newborns only, which has a very high accuracy rate in~     placing the tube-tip at the mid-tracheal point. In addition, it is easy to learn and without~     side effects. In infants and children, SSTTP is widely used in Switzerland although never~     validated in a controlled trial.~      Objective:~      To validate supra-sternal palpation of the endo-tracheal tube tip as a valuable measure to~     correctly determine the depth of intubation in infants from one month of age to children up~     to eight years of age, when correct depth of the tube-tip is defined as tube-tip being within~     plus/minus 0.25cm of the line between the medial points of the claviculae (IMP) for infants~     and within plus/mius 0.25 respectively plus/mius 0.38cm for toddlers and children.~      Hypothesis:~      Supra-sternal Tube Tip Palpation (SSTTP) is a valid and easy to perform measure to identify~     the correct depth of intubation after oral or nasal tracheal intubation in infants, toddlers~     and children. Correct depth is defined as tube tip placed within plus/minus 0.25cm of the IMP~     for infants and within plus/minus 0.25 respectively plus/minus 0.38cm for toddlers and~     children.~      Study design and methods:~      Sixty-four toddlers and children and 18 infants will be enrolled into the study. Three~     Respiratory Therapists (RT) from the Pediatric Intensive Care Unit (PICU) will be trained in~     SSTTP before the start of the study. Successful training of the RTs will be confirmed by~     x-ray before final qualification as Expert in SSTTP. All patients with an intubation~     requiring a post-manipulation x-ray in the PICU at CHEO will be enrolled into the study. No~     randomization will be necessary; all infants and children in need of an intubation will be~     enrolled into the study. Potential patients will be excluded if there is presence of~     anatomical malformation or any other reason that would prevent accurate SSTTP, or if there is~     no Expert in SSTTP available. The location of the tip of the tube after SSTTP will be~     measured on standard post-intubation x-rays by a radiologist. The tube-tip location~     difference will be calculated as the difference between the actual tube-tip location and the~     IMP.~   "
219147|NCT00690495|"~     The purpose of the study is to determine whether a modified propofol preparation shows any~     effect on the incidence of injection pain in adults undergoing elective surgery under general~     anesthesia.~      Study hypothesis: The use of a modified propofol preparation will reduce the incidence of~     injection pain in the study group.~   "
219148|NCT00690482|"~     The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic~     Obstructive Pulmonary Disease~   "
219149|NCT00690469|"~     This laboratory study is looking at genetic mutations and environmental exposure in young~     patients with retinoblastoma and in their parents and young healthy unrelated volunteers.~     Gathering information about gene mutations and environmental exposure may help doctors learn~     more about the causes of retinoblastoma in young patients.~   "
219150|NCT00690456|"~     The primary objective of the study is to determine the effect of rimonabant 20 mg daily when~     added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in~     patients with type 2 diabetes.~      Secondary objectives include evaluation of other markers of glycemic control, lipid profile,~     body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when~     added to metformin over a period of 47 weeks.~   "
219151|NCT00690443|"~     Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus~     monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy~     parameter is percent change in LDL-C after 8 weeks of therapy.~   "
219152|NCT00690430|"~     The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of~     paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are~     inadequately controlled by currently available somatostatin analogues.~   "
219153|NCT00690417|"~     The purpose of the research is to describe vitamin D levels and bone status in a rural~     Wisconsin population. It is probable that individuals of varying age and ethnicity require~     different amounts of D to achieve optimal status. These likely scenarios will be explored in~     various populations. We hypothesize that the increase in serum 25(OH)D resulting from daily~     D3 ingestion is less pronounced with advancing age and different in Native than Caucasian~     Americans. In addition, the women in the middle age group, between the ages of 55 and 65,~     will have ultrasound tests completed to assess the impact of the Vitamin D supplementation on~     cardiovascular health.~   "
219154|NCT00690404|"~     A open label two way crossover formulation and food effect study in healthy volunteers to~     assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an~     oral solution~   "
219155|NCT00690391|"~     The purpose of this study is to define if palliative surgery in patients with cancer improves~     quality of life and prognosis.~   "
219156|NCT00690378|"~     The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the~     treatment of complicated urinary tract infections as compared to a comparator group.~   "
219157|NCT00690365|"~     This is a single-arm, phase IV, open-label, prospective, non interventional study in~     approximately 600 patients that will be followed for 6 months in order to evaluate the safety~     and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration~     period from their previous antipsychotic medication to quetiapine according to the approved~     SPC.~   "
219158|NCT00690352|"~     This social science study hypothesizes that convicted felony drug offenders in Nebraska who~     participated in Specialized Substance Abuse Supervision (SSAS) as part of their probation or~     parole showed significantly better outcomes (specifically, less recidivism) at six months~     post-entrance to SSAS compared to those who did not participate in SSAS.~   "
219159|NCT00690339|"~     Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing~     primary augmentation, primary reconstruction, or revision of existing breast implants.~   "
219210|NCT00689676|"~     The aim of the present study is to describe the performance of very low birth-weight preterm~     toddlers regarding expressive language and cognitive development during sensorimotor and~     beginning of pre-operational periods, as well as to compare the performance presented by~     these children to that presented by their full-term peers, according to Genetic Epistemology~     theoretical principles.~      The hypothesis of this study is that very-low birth weight preterms would present a poorer~     performance, concerning expressive language and cognition development,than their full-term~     peers.~   "
219160|NCT00690326|"~     Type 2DM is present in the populations of almost all the countries in the world and is a~     significant disease burden in most countries .Evidences suggest that population in India~     develop Type 2 DM at an increasing rate as they reject their traditional life styles.~      Awareness and knowledge regarding Diabetes and role of physical inactivity in producing~     complications is still grossly inadequate( Mohan. D, Raj.D Awareness and knowledge of~     Diabetes in Chennai.The Chennai urban Rural Epidemiology study(CURES-9)J Assoc. Physicians~     India 2005 April;53:283-7).Exercise is a low cost , non pharmacological intervention that has~     been shown to be effective in metabolic control. Exercise is still vastly under-utilized in~     the management of Type 2 DM.~      Most proximal behavioral cause of insulin resistance is physical inactivity.(Michael J.~     LaMonte, Steven N. Blair et al.( Physical activity and Diabetes prevention J Appl Physiol.~     99: 1205-1213,2005)~      This study was designed to promote physical activity among type 2 DM female subjects aged~     35-65 yrs attending Diabetic clinic of a tertiary care hospital in Kerala.~   "
219161|NCT00690313|"~     Antibiotic eye drops are being used before and after intravitreal injections. Currently there~     is no study indicating the benefit of there usage or their dosage.~      In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior~     to the injection versus 1 day prior to intravitreal injection.~   "
219162|NCT00690300|"~     The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in~     patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of~     a palliative first line therapy.~   "
219163|NCT00690287|"~     The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study~     safety and tolerability in patients with type 2 diabetes.~   "
219164|NCT00690274|"~     To evaluate the cognitive enhancing effect of BF2.649 and to evaluate the effect of BF2.649~     on symptom severity in persons with schizophrenia or schizoaffective disorder.~   "
219165|NCT00690261|"~     The purpose of this study is to evaluate the correlation between M1/M2 phenotype of tumor~     associated macrophage (TAM) in lung cancer patients and clinical outcome.~   "
219166|NCT00690248|"~     Observational, non-interventional, transversal, multicenter, open label (No treatment is~     involved). The primary objective is to detect the prevalence of depressive symptoms in~     bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Secondary~     objectives include 1) to evaluate, the relationship between depressive symptoms and severity~     of mania; 2) to evaluate, the relationship between depressive symptoms and anxiety; 3) to~     evaluate, the relationship between depressive symptoms and psychotic symptoms; 4) to~     evaluate, the relationship between depressive symptoms and insight; 5) to evaluate, the~     relationship between depressive symptoms and clinical global impression; 6) to evaluate, the~     relationship between depressive symptoms and previous treatment with antipsychotics (whatever~     the antipsychotic was); 7) to evaluate, the relationship between depressive symptoms and~     length of admission; 8) to evaluate factors (demographic, evolution…) which could be involved~     in the presence of depressive symptoms within an acute manic episode; 9) to evaluate, the~     difference on the initial prescription due to the detection of depressive symptoms; 10) to~     evaluate, if exists, differences on the previous psychiatric diagnosis in patients with and~     without depressive symptoms. The primary endpoint is score of the MADRS (Montgomery-Asberg~     Depression Rating Scale) in bipolar patients with acute mania~   "
219167|NCT00690235|"~     Primary Objective:~      To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight~     gain in persons with schizophrenia who are currently taking either drug; measures of the~     metabolic syndrome will be evaluated as well.~      Secondary Objective To evaluate the action of pramlintide on cognition in schizophrenia and~     on psychotic symptoms of the illness.~   "
219168|NCT00690222|"~     The purpose is to determine if an intracameral solution of 0.2% tropicamide and 2%~     phenylephrine can dilate the pupil for cataract surgery as well as pre-operative topical 1%~     tropicamide and 5% phenylephrine. We will be looking at two separate groups of patients,~     those with and those without pseudoexfoliation syndrome.~      We will be looking at how each method affects the size of the pupil at the beginning and at~     the end of cataract surgery. In addittion, we will look at what effect the two different~     methods have on blood pressure and heart rate in the pre-operative, peri-operative and~     post-operative periods.~   "
219169|NCT00690209|"~     Surgical revascularization has proven its efficacy in term of morbidity and mortality in~     patients with multivessel coronary disease and poor left ventricular function. Nevertheless,~     if left ventricle is severely dilated, the improvement of global contractility and reduction~     of volumes is frequently absent after CABG even if substantial amount of myocardial viability~     is present. A value of > 140 ml for end systolic volume has been proposed as the cut off for~     the absence of recovery after revascularization.~      Recently, a reduction of cardiac volumes and improvement of regional and global contractility~     has been demonstrated in patients with advanced ischemic heart disease, severe dilation of~     left ventricle and poor candidates for revascularization after injection of stem cells in~     territories with residual viability.~   "
219170|NCT00690196|"~     Breast Cancer is the most common cancer in women. After completion of successful therapy, may~     behavioral symptoms persist with over 20% of breast cancer survivors reporting chronic~     insomnia of greater than 6 months duration that fulfils clinical diagnostic criteria with~     associated functional limitations, decreased quality of life, and possible effects on~     long-term survival. Behavioral interventions are highly efficacious in the treatment of~     insomnia and preferred over hypnotic medication when insomnia is chronic. However, insomnia~     studies conducted in cancer are scarce. The proposed research builds upon program of study~     that has examined the efficacy of mind-body intervention, Tai Chi Chih (TCC), on health~     outcomes including sleep impairments. Preliminary studies show that TTC, a slow moving~     meditation, contributes to improvement in subjective sleep quality, sleep amounts and sleep~     efficiency. The investigators have further found that sleep, fatigue and proinflammatory~     cytokine activity are reciprocally related and that TCC decreases the mechanism through TCC~     carries its effects on sleep outcomes.~   "
219211|NCT00689663|"~     Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as~     a fundus first dissection.~      Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way~     of dissection has to be established. Patients are at 4 hospitals randomised to the different~     techniques and the different methods of dissection.~   "
219171|NCT00690183|"~     Increased numbers of circulating stem cells and physical activity are both associated with~     improved health in older persons. This pilot study is the initial step in developing a~     collaborative, translational research project investigating whether physical activity may in~     part exert a positive influence on aging via the mobilization of stem cells. The specific aim~     of this pilot project is to collect preliminary data to explore the relationship between~     physical activity and stem cell populations found in the blood and to determine the variance~     in the number of circulating stem cells. We hypothesize that stem cell decrease with age, but~     that persons who are more physically active will have a higher number of stem cells in the~     blood. A maximum of 40 persons will be recruited to participate. Persons are eligible to~     participate if they are age 60 or older, haven't been hospitalized recently, do not have an~     immunologic or blood disease, do not have an infection, and are not undergoing chemotherapy.~     Subjects will have 2 visits to the UNMC Clinical Research Center (CRC). The first assessment~     will include an evaluation of health, physical activity and lifestyle via questionnaires.~     Height, weight and abdominal girth will be measured, and blood will be drawn for immune and~     stem cell assessment. Subjects will be given a pedometer and accelerometer to wear daily for~     7 days. Subjects will return to the CRC for a second visit at which the pedometer and~     accelerometer will be returned and blood will be drawn. Stem cell and immune assays will be~     repeated to evaluate the variability of these measures over time. The correlation between~     stem cell numbers and physical activity will be analyzed. The data will be used to perform~     sample size calculations for the development of future studies.~   "
219172|NCT00690170|"~     This study examines the interactive effects of ketamine and nicotine.~   "
219173|NCT00690157|"~     Main goal of the study is the risk stratification of patients with advanced heart failure~     referred for orthotopic heart transplantation (OHT) according to HFSS score, other risk~     factors and biological markers and verification of their prognostic value in Polish~     population.~   "
219174|NCT00690144|"~     The purpose of this study is to determine whether the use of high-fidelity simulation in~     health care education is an effective training and evaluation model.~   "
219175|NCT00690131|"~     This 3-year study will involve the design and small-scale clinical trial of a behavioral~     treatment program for smoking cessation in people with severe mental illness (called~     Behavioral Treatment for Smoking Cessation in Serious and Persistent Mental Illness or BTSCS)~     in two psychosocial rehabilitation programs (PRPs) in Baltimore. Our aims are: (1) Develop~     intervention materials and examine feasibility, acceptability, and safety; (2) Measure the~     effects of the intervention at post-treatment and 3-month follow-up on rates of smoking~     cessation, number of quit attempts, rates of smoking reduction and intention/motivation to~     quit smoking.~   "
219176|NCT00690118|"~     Primary objective:~      Efficacy of pioglitazone (45 mg/day) as add-on therapy to standard therapy with riluzole in~     patients with ALS compared to placebo in terms of survival (mortality defined exclusively as~     death).~      This is a prospective, multicentre, randomised, stratified, parallel-group, double-blind~     trial comparing placebo with 45 mg pioglitazone as add-on therapy to 100 mg riluzole in ALS~     in 220 enrolled patients. For entry, the El Escorial Criteria for diagnosis will be used. The~     duration of treatment will be 18 months. The primary endpoint will be subjected to a~     confirmatory analyses. Secondary variables will be incidence of tracheotomy or non-invasive~     ventilation, ALS Functional Rating Scale, Quality of life and safety variables.~   "
219177|NCT00690105|"~     Patients with facial atopic eczema and a poor response to topical corticosteroid applied~     either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3~     more weeks once a day if needed or change for the other ointment.~   "
219178|NCT00690092|"~     Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test~     antigen was evaluated in three different populations of adult volunteers to determine the~     safety and efficacy of the product in the assessment of delayed-type hypersensitivity to~     Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered~     positive for exposure to C. immitis.~   "
219179|NCT00690079|"~     The study is being performed in order to learn more about the safety and tolerability of~     AZD1386. AZD1386 is primary intended for treatment of chronic pain.~   "
219180|NCT00690066|"~     The purpose of this study is to establish the safety and efficacy of multiple administrations~     of PROCHYMAL® in subjects recently diagnosed with type 1 diabetes mellitus.~   "
219181|NCT00690053|"~     Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients~     having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as~     bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the~     compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in~     patients. However, bad image quality and unpredictable kinetics limit their use. In extensive~     pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic~     new probe to determine hypoxia.~   "
219182|NCT00690040|"~     The purpose of this study is to compare between single balloon catheter and double balloon~     catheter for ripening the cervix among pregnant with unfavorable cervix.~   "
219183|NCT00690027|"~     In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on~     mortality rate, duration of life, quality of life, and economic costs of treatment of:~        -  Emergency portacaval shunt, and~        -  Emergency and long-term endoscopic sclerotherapy.~   "
219197|NCT00689845|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Giving rituximab together with one of five different~     combination chemotherapy regimens may kill more cancer cells.~      PURPOSE: This clinical trial is studying giving rituximab together with combination~     chemotherapy to see how well it works in treating patients with primary mediastinal diffuse~     large B-cell lymphoma.~   "
219198|NCT00689832|"~     Children with atopic eczema and a poor response to topical corticosteroid applied either~     Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more~     weeks once a day if needed.~   "
219212|NCT00689650|"~     The objective was to evaluate the efficacy of 1540 nm fractional laser treatment of mature~     burn scars.~   "
219184|NCT00690014|"~     The process of drug elimination that occurs within the kidneys is complex, and involves~     filtration, secretion and absorptive mechanisms. Many drugs, metabolites and toxins,~     including organic anions and cations, rely on renal mechanisms for elimination from the body.~     Failure to recognize the contribution of renal mechanisms involved in drug elimination during~     the drug development process can result in drug interactions or toxicity in clinical trials.~     This is increasingly important due to the use of OAT1 inhibitors such as probenecid that are~     being used in adjuvant treatment regimens. Thus, in order to more fully understand the~     effects renal disease, drugs and nephrotoxins on the renal transport pathways of tubular~     secretion in humans, novel approaches that incorporate both in vitro (experimental) as well~     as clinical observations (clinical trial), also called in-vitro/in-vivo correlations (IVIVC)~     need to be developed. These methods can then be used to identify and evaluate specific kidney~     probe drugs that undergo extensive tubular secretion. Such approaches are needed to~     characterize drug clearance by tubular mechanisms and to identify potentially significant~     drug-drug interactions prior to exposure to patients in Phase 2 and 3 clinical trials. This~     investigator-initiated pilot project aims to determine the pharmacokinetics of selected~     FDA-approved compounds (PAH, iothalamate) for use in IVIVC model development. The proposed~     research is innovative, because it involves a translational approach to development of an~     IVIVC model applied to renal drug clearance. It is our expectation that the resultant~     approach will further our understanding of pharmacogenomics, inter-subject variability and~     renal drug clearance. This approach will generate important new information regarding in~     vitro drug-drug interactions in light of many new and potent OAT1 blocking agents being~     introduced for the treatment of human diseases. In future studies, we hope to fully~     characterize the effects of diseases such as diabetes, hypertension, and nephropathy on renal~     drug transport mechanisms using IVIVC models. We expect that results from this NIH-funded~     study will provide needed preliminary data to design future pharmacogenomic and drug~     interaction studies in humans.~   "
219185|NCT00690001|"~     To assess the HIV resistance rate to variable antiretroviral agents in Taiwan, especially in~     patients with treatment failure, and to know the correlation between the drug resistance~     pattern and the HIV subtype, we will enroll a total of 150~200 HIV-1-infected subjects to~     perform genotypic resistance testing and try to establish facility of phenotypic resistance~     testing.~   "
219186|NCT00689988|"~     Children with Down syndrome (DS) have language development particularities that have negative~     effects in the communication capacity. By this way, Augmentative and Alternative~     Communication (AAC) is indicated to this population. The aim of this study was to verify the~     AAC impact in the lexical gain of children with DS.~   "
219187|NCT00689975|"~     RATIONALE: Studying diet and exercise interventions in overweight and obese patients with~     breast cancer may help doctors learn more about how to help patients lose weight and change~     their body composition.~      PURPOSE: This randomized clinical trial is studying diet and exercise to see how well it~     works compared with normal care in overweight or obese women who have undergone treatment for~     stage I, stage II, or stage III breast cancer.~   "
219188|NCT00689962|"~     I hypothesize that absorbable screw fixation of the foot's Lisfranc ligaments does not yield~     significant differences in postoperative foot stability, ligament function, and symptoms when~     compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc~     ligaments offers the advantage that a second surgical procedure to remove the screw is not~     necessary.~   "
219189|NCT00689949|"~     The major objective of the proposed study is to demonstrate the suitability of new markers~     for folate status in humans, which avoid blood sampling, as required for the established~     marker RBC folate concentration, but can be obtained from spot urine samples. For this reason~     urine and blood will be collected from volunteers, twice at baseline and in a subgroup after~     6 and 12 weeks of intake of a folic acid supplement~      Specific hypotheses to be tested:~      Correlation study:~        -  The 24 h urinary excretion of total p-ABG, as extrapolated via urinary creatinine~          concentration from the total p-ABG concentration in a spot sample is significantly~          correlated to RBC and plasma folate levels in the studied subjects~        -  The 24 h urinary excretion of FIGLU, as extrapolated via urinary creatinine~          concentration form the FIGLU concentration in a spot sample is significantly correlated~          to RBC and plasma folate levels in the studied subjects~      Intervention study:~      Changes in folate status (RBC folate) after supplementary intake of folate result in~     increased urinary excretion of total p-ABG and FIGLU in subjects identified with a low folate~     status and in subjects identified with a high folate status among the study participants of~     the correlation study~   "
219190|NCT00689936|"~     The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose~     dexamethasone to that of the combination of melphalan, prednisone and thalidomide.~   "
219191|NCT00689923|"~     Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out~     come in pain relief.~   "
219192|NCT00689910|"~     This study will evaluate the pharmacokinetic disposition of raltegravir in pregnant HIV-1~     infected women. These results will be compared to pharmacokinetic data obtained following~     pregnancy as well as to studies previously carried out in nonpregnant women and male~     patients. By determining the disposition characteristics for this specific patient~     population, antiretroviral (ARV) dosing can be optimized during pregnancy. Appropriate dosing~     is necessary to minimize adverse effects, slow progression of disease, and further reduce the~     risk for vertical transmission. Data will also be obtained on genital tract penetration and~     placenta transfer of raltegravir to the newborn.~      The subjects enrolled in this study will take an antiretroviral based regimen containing~     raltegravir twice daily both during and after their pregnancy. The specific regimen will be~     chosen by their own primary care provider based on their antiretroviral history and~     resistance testing. They will undergo a series of blood sampling for pharmacokinetic analysis~     over 12 hours on two occasions; a) during their 3rd trimester and b) approximately 3 months~     postpartum. Concentrations of raltegravir in the infant will be assessed by cord and infant~     blood sample at delivery and a blood sample at approximately 3 months of age.~      Hypothesis: The pharmacokinetic exposure of raltegravir as measured by the 12 hour area under~     the plasma concentration versus time curve (AUC0-12h) during third trimester pregnancy is~     similar to the AUC0-12h estimated three months post-partum.~   "
219193|NCT00689897|"~     The objective of this study is to evaluate the associations between deqi, the effects of~     acupuncture and personality in primary dysmenorrhea and to characterize the nature of the~     deqi phenomenon on terms of the prevalence of sensations as well as the uniqueness of the~     sensations underlying the deqi experiment.~   "
219194|NCT00689884|"~     The purpose of this study is to determine the efficacy of Pegfilgrastim in the mobilization~     of autologous peripheral blood stem cells (PBSCs), defined as cell yield ≥ 3 x 10e6 CD34+/kg~     and to assess the costs related to Pegfilgrastim use in the mobilization of autologous PBSCs.~     Also to determine the side effects of Pegfilgrastim in the mobilization of autologous~     peripheral blood stem cells.~   "
237446|NCT00447226|"~     This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive~     ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.~   "
219199|NCT00689819|"~     This project will evaluate the clinical and cost effectiveness of a novel, multidisciplinary~     approach to identify and treat pre-clinical cardiac dysfunction (PCCD) in asymptomatic~     hypertensive patients identified in a single center urban emergency department. Premature~     onset of pressure-related cardiac complications of hypertension (especially heart failure)~     has important implications for long-term survival, quality of life and healthcare costs. This~     project will target patients who have already developed pressure-related cardiac structural~     abnormalities yet remain symptom free. These individuals are at tremendous risk for~     progression to clinically overt heart failure and its associated consequences. We hypothesize~     that detection and treatment of patients with hypertension who have pre-clinical structural~     cardiac damage will enable forestallment of the disease process and offer the opportunity to~     reduce the burden of cardiac morbidity associated with hypertension. This project will~     implement a program to prospectively identify PCCD (using echocardiography) and provide~     treatment. At present, the optimal blood pressure goal for patients with PCCD is unknown so~     this study will randomize patients to 2 levels of blood pressure control: normal, which is~     consistent with current national guidelines and intensive, which will aim for a markedly~     lower blood pressure (< 120/80). Enrolled patients will receive active treatment and~     follow-up for 1 year. At the end of 1 year, we will evaluate: 1) the ability of this program~     to achieve blood pressure goals; 2) the cost effectiveness; and 3) the proportion in each~     blood pressure group who have evidence of disease regression on echocardiography.~   "
219200|NCT00689806|"~     This study has two purposes:~        1. to determine whether lovastatin, a commonly used medication to lower cholesterol in the~          blood, can produce beneficial changes in airway inflammation and in the airway smooth~          muscle~        2. to examine whether lovastatin will have favorable changes in asthma symptoms of patients~          with moderate or severe asthma.~   "
219201|NCT00689793|"~     The purpose of this study is to determine the subjective response of iron substitution~     (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin < 30ng/ml and to~     assess variation of ferritin and hemoglobin after a blood donation.~   "
219202|NCT00689780|"~     A Phase I, Multi-Centre, Randomised, Double-blind, Placebo-controlled Study to Investigate~     the Safety, Tolerability and Pharmacokinetics of AZD1940, Including an Interaction Study,~     After Administration of Oral Multiple Ascending Doses in Adult Subjects with Chronic Low Back~     Pain~   "
219203|NCT00689767|"~     This First In Man study is a prospective, multicentre, single blind, randomized, controlled~     clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the~     CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7~     sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post~     procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point~     for all subjects.~   "
219204|NCT00689754|"~     Upper gastrointestinal tract hemorrhage (UGIH) remains a major cause of morbidity and~     mortality . Nasogastric aspiration (NGA) is routinely performed in patients with UGIH to~     obtain important clinical data and make therapeutic decisions. But routine use of NGA remains~     controversial with studies reporting its usefulness and its redundant clinical information.~     Early esophagogastroduodenoscopy (EGD) is recommended by most gastrointestinal societies to~     allow for risk stratification and to perform endoscopic treatments. The results of the NGA~     may assist to differentiate between high-risk versus low-risk lesions. Our hypothesis is that~     presence of NGA can identify lesions that require endoscopic treatment and provides important~     clinical information to guide the treating physician. In addition, we hypothesized that the~     results of the NGA influence the clinical decision of the treating physician regarding the~     prediction of the need for endoscopic therapy. This observational randomized cross-sectional~     study will enroll consecutive patients with presumed UGIH and randomized them to NGA and no~     NGA recording its results. All patients will receive an EGD and its results will also be~     recorded. Subsequently, we will evaluate if the NGA is important in identifying~     endoscopically significant lesions. The information gained will help guide clinicians~     evaluating patient with UGIH.~   "
219205|NCT00689741|"~     The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the~     HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent~     and young adult women. A vaccine that prevents, or even reduces, the incidence of the common~     types of high-risk HPVs, particularly HPV-16 and HPV-18, could result in significant~     reduction in the incidence of cervical cancer and cancer-related mortality, as well as a~     reduction in the incidence of surgical procedures following abnormal Pap smears.~   "
219206|NCT00689728|"~     The purpose of this study is to explore whether LY2127399 is effective in relieving signs and~     symptoms of RA in patients with a history of inadequate response or intolerance to at least 1~     TNFα inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the~     market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).~   "
219207|NCT00689715|"~     Cystic lesions of the pancreas are defined as round, fluid-filled structures within the~     pancreas detected by radiologic imaging. With widespread use of cross-sectional imaging~     modalities for various indications, such lesions are now detected in nearly 20% of abdominal~     imagings, with the majority discovered incidentally. These lesions encompass a wide spectrum~     of histopathologic entities and biologic behavior, ranging from benign to malignant.~     Substantial morphologic overlap restricts the accuracy in diagnosing specific type of cystic~     lesion in spite of recent advances in diagnostic modalities. It is a challenging issue to~     differentiate each cystic lesion and make a management plan since cystic lesions that are~     relatively common and asymptomatic may possess malignant potential. Although inflammatory~     pseudocysts were thought to account for 80-90% of cystic lesions of the pancreas, with cystic~     tumors accounting for the remaining,10 the latter may occur much more frequently than~     traditionally estimated.~      To date, surgical resection is generally recommended for malignant and potentially malignant~     lesions. However, surgical resection of the pancreas still carries substantial morbidity and~     sometimes mortality, especially for the cystic lesion located in the head portion. Therefore,~     management should be individualized by risk-benefit analysis for each patient.~      Recently, a pilot study of EUS-guided ethanol lavage for cystic tumors of the pancreas~     reported that complete resolution was achieved in only one-third of patients even though~     epithelial lining ablation was demonstrated in all resected specimens. Therefore, more~     effective treatment modalities or ablation agents are required to improve treatment~     responses. Intratumoral or intraperitoneal injection of chemotherapeutic agent has been used~     for endobronchial lesions of lung cancer, brain tumors and advanced ovarian cancer.13-16~     EUS-guided injection of antitumor material has been reported in advanced pancreatic cancer.~     Although local injection of chemotherapeutic agents into pancreatic cystic tumors has not yet~     been reported, it is reasonable to suggest that such an approach may have an additive effect~     on ablation of the epithelial lining of cystic tumor when combined with ethanol lavage.~      Paclitaxel, a widely used chemotherapeutic agent, inhibits cell processes that are dependent~     on microtubule turnover. Due to its highly hydrophobic nature,19 paclitaxel is expected to~     exert its effect longer when instilled within a closed cavity such as a cyst. The hydrophobic~     and viscous nature of paclitaxel may reduce the possibility of it leaking through a puncture~     site and causing complications.~      The present study evaluated safety, feasibility and response following EUS-guided ethanol~     lavage with paclitaxel injection (EUS-EP) for treating cystic tumors of the pancreas.~   "
219215|NCT00689611|"~     Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent~     event or death compared with those who quit. Many patients attempt to stop smoking after a~     heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been~     shown to be effective for the general population. However, bupropion is the only non-nicotine~     replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore,~     nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a~     heart attack because of the undesirable effects of nicotine. Although bupropion has been~     successfully used to reduce smoking rates in healthy young populations, its efficacy and~     safety in the setting of patients recovering from an ACS is unknown. These patients, if they~     continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion~     is effective in this population, it will have a major impact on secondary prevention of~     recurrent clinical events in patients who suffer a heart attack.~   "
219216|NCT00689598|"~     To determine whether or not spironolactone can prevent or delay the occurrence of atrial~     fibrillation.~   "
219217|NCT00689585|"~     Pain remains the most debilitating symptom for adult patients suffering from complex regional~     pain syndrome (CRPS). Most CRPS patients gain little to no relief from current painkillers.~     The purpose of this study is to evaluate the efficacy and safety of ethosuximide in search of~     much-needed adjunctive therapy to relieve the pain and suffering associated with CRPS.~   "
219218|NCT00689572|"~     This study will evaluate the efficacy of ondansetron compared with placebo in the treatment~     of cocaine dependence.~   "
219219|NCT00689559|"~     The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or~     not, i.e. show the same or altered plasma concentration profiles when co-administered~     compared to administered alone.~   "
219220|NCT00689546|"~     It has been observed that several of patients having prolonged or complicated course of acute~     viral hepatitis have underlying diabetes. It is possible that with impaired hepatocyte~     regenerating capacity, these patients run a more prolonged and complicated course.~      We hypothesize that acute hepatitis infection has a prolonged and complicated course among~     diabetic patients.~   "
219221|NCT00689533|"~     Primary Objective: To evaluate the use of unilateral or bilateral VEPTR devices, with or~     without expansion thoracoplasty, for preventing further progression of the Cobb angle,~     allowing for spinal growth and improving pulmonary function in the treatment of children with~     progressive scoliosis without rib abnormalities.~   "
219222|NCT00689520|"~     The purpose of this study is to evaluate whether low-molecular-weight heparin could be~     equally or more effective than oral anticoagulation in the long-term treatment of deep venous~     thrombosis.~   "
219223|NCT00689507|"~     H9S-MC-JDCF was a multicenter non-randomized, single-arm, open-label, dose-escalation, dose~     confirmation, Phase 1 study of intravenous (IV) LY2127399 in combination with bortezomib in~     patients with refractory or relapsed MM.~   "
219224|NCT00689494|"~     Measure blood progesterone by using cervical device contraception.~   "
219225|NCT00689481|"~     The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with~     plaque-type psoriasis.~   "
219226|NCT00689468|"~     This study was designed to evaluate the efficacy of the herb Echinacea purpurea and of~     cranial osteopathic manipulative treatment to prevent otitis media (middle ear infections) in~     young children.~   "
219227|NCT00689455|"~     The aim of the study, is to assess the prevalence of Metabolic Syndrome in Italy on a~     regional basis, defined according to NCEP/ATPIII Guidelines criteria.~   "
219228|NCT00689442|"~     The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of~     JTT-705 compared with placebo when co-administered with atorvastatin 20 mg in patients with~     low HDL~   "
219229|NCT00689429|"~     A chart review will be performed to extrapolate information including sex, height, weight,~     date/time admitted to HMC, injury data, comorbidities, fracture pattern, antibiotic usage,~     surgical history, wound history, fracture healing, and length of time to return to work.~     Dr.'s Goodspeed and Reid will conduct a radiographic review independently for each subject,~     classifying all fractures according to the Orthopaedic Trauma Association classification~     guide. If a discrepancy in classification is found, then both will discuss together and come~     to a consensus.~   "
219230|NCT00689416|"~     The primary aim of this study is to investigate the effect of 40 mg dose of rosuvastatin on~     carotid plaque inflammation measured with MRI and PET scanning, to evaluate whether these~     techniques are promising for future proof of principle studies. A number of patients will~     receive placebo as a control.~   "
219231|NCT00689403|"~     To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.~   "
219232|NCT00689390|"~     Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated~     with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants~     will be followed for up to 3.5 years after the end of their participation in the treatment~     protocol to document maintenance of the antiviral response (for sustained responders) and to~     characterize the long-term safety after use of this therapeutic regimen. LTFU procedures~     include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid~     (HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will~     be administered as part of this study.~   "
219233|NCT00689377|"~     Non interventional study aimed to establish the prevalence of lower extremity peripheral~     arterial disease (PAD), defined as an ankle-brachial index (ABI) not above 0.90 in subjects~     with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor~     diabetes mellitus.~   "
219234|NCT00689364|"~     Comprehensive therapy of traditional Chinese medicine (CTTCM) could relieve risk of~     recurrence and metastasis for stage II & III colorectal cancer, the investigators take this~     clinical trial with retrospective-prospective cohort study based on previous studies by~     international multi-center way.~      If the study shows a positive result, a pragmatic randomized controlled study with~     prospective, multi-centre and large-sample design will be given continuously. The aim is to~     establish recommended programs suggested by CTTCM strategies under conventional Western~     medicine therapy (CWMT) for stage II & III colorectal cancer.~   "
222439|NCT00647179|"~     The purpose of this study is to investigate the effects of chronic elevated growth hormone on~     metabolism and insulin sensitivity by studying acromegalic patients before and after~     treatment.~   "
219240|NCT00689286|"~     Osteoarthritic changes in the knee are a common cause of pain that restricts the subject's~     ability to move and may lead to surgical intervention with total knee replacement. Quadriceps~     muscle strengthening has been shown to improve the dynamic stability of the knee, decreasing~     pain during locomotion and increasing knee function. However, the gains associated with~     improved quadriceps strength have been difficult to achieve on a routine clinical basis~     because the currently available ways to increase muscle strength- through voluntary exercise~     or surface electrical stimulation- have significant practical problems that limit their use.~     The aim of this prospective study is to evaluate the safety and effectiveness of~     neuromuscular stimulation using implantable microstimulators called BIONs to improve the~     strength, range of motion, and health of the knee in patients with knee osteoarthritis. This~     investigation is expected to last 12 weeks for each study participant; the trial will be~     completed over a 3-year period. Patients recruited into the study will have advanced knee~     osteoarthritis for which total knee replacement surgery is being considered. The proposed~     study extends a feasibility study carried out in Milan, Italy on five patients with knee~     osteoarthritis, who were implanted with BIONs.~   "
219241|NCT00689273|"~     To evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics in~     patients with osteoarthritic pain of the knee. The most painful knee joint will be identified~     as the index joint at screening, and this joint will be used for all pain assessments~     throughout the study.~   "
219242|NCT00689260|"~     This study will help to determine whether an injection log on a recombinant human growth~     hormone (rhGH) delivery device improves subjects' adherence with injection schedules.~     Adherence will be compared between a group of subjects who are aware of the injection log on~     the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™~     injection log. It is the study hypothesis that subject non-adherence rate is different for~     those who are aware of the injection log capability versus those who are unaware of the~     injection log capability. Subject perception will also be evaluated by comparing the ease and~     convenience of use and subject preference for the easypod™ compared to two other rhGH pen~     injection devices.~   "
219243|NCT00689247|"~     The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the~     absorption, distribution, metabolism and excretion of AZD1305.~   "
219244|NCT00689234|"~     The purpose of the study is to investigate the impact of unilateral or bilateral diaphragm~     plication in a prospective randomised controlled way on symptoms, pulmonary function~     including gas exchange, respiratory muscle strength, exercise capacity and breathing during~     sleep in patients with proven uni- or bilateral phrenic nerve paralysis present for at least~     1 year without any evidence of spontaneous recovery.~   "
219245|NCT00689221|"~     CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational~     integrin inhibitor, cilengitide, in combination with standard treatment versus standard~     treatment alone in newly diagnosed glioblastoma subjects with a methylated~     O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor~     tissue.~      The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling~     element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be~     a predictive marker for benefit from temozolomide (TMZ) treatment.~   "
219246|NCT00689208|"~     The present study on pharmacological intervention in autonomic nervous~     dysregulation(parasympathetic dysfunction,) regarding insulin resistance, is a concept~     testing in humans tohelp identify potential new pharmacological target sites in the central~     nervous system.~   "
219247|NCT00689195|"~     Curcumin as well as the ashwagandha extract are ingredients from traditional indian medicine~     and have been shown to be potent anti-cancer compounds in laboratory as well as animal~     studies. This study will test the safety and efficacy of a curcumin formulation and the~     ashwagandha extract in high grade relapsed or metastatic osteosarcoma where no other second~     line chemotherapy is being given. The pharmacokinetics will be studied along with response as~     measured on CT scans and PET scans as well as the quality of life and any toxicity.~   "
219248|NCT00689182|"~     Hypothesis: The reduction of total body iron by phlebotomy will be safe and feasible in the~     post-HSCT setting~      Iron overload is common after hematopoietic stem cell transplantation. It is associated with~     chronic liver disease, with increased rates of infection and decreased survival.~      Eligible, consenting patients will have once monthly phlebotomy procedures (500ml) for 12~     months.~      SAFETY: At each visit, patients will have a comprehensive assessment prior to starting and~     after completing the phlebotomy. This assessment will include determination of pain at~     phlebotomy site, local infection and an assessment of symptoms of anemia including~     presyncope, fatigue and dyspnea. The patient's pulse, blood pressure, respiratory rate and~     temperature will also be determined before and following the phlebotomy.~      EFFICACY: Iron stores will be measured serially in each patient. Measurements will be~     performed prior to the start of phlebotomy, and at 6 months and 12 months following the start~     of the series of 12 phlebotomies. These evaluations will be undertaken regardless of the~     number of phlebotomies which the patient actually undergoes. Iron stores will be estimated by~     measuring serum ferritin and transferrin saturation levels. Total body iron will be estimated~     from hepatic and cardiac iron concentration as measured by magnetic resonance imaging (MRI).~     Gandon et al. (12) described a non-invasive technique using MRI to measure hepatic iron~     stores. Iron is a paramagnetic substance which causes local magnetic field inhomogeneities~     leading to dephasing and signal loss in MRI. Gradient echo sequences are most susceptible to~     their effects because they do not use a 180° refocusing pulse, unlike conventional spin-echo~     sequences. Gandon et al. used multiple gradient echo sequences, compared the signal in liver~     to adjacent muscle and used this ratio to correlate with hepatic iron levels measured on~     tissue biopsy samples using spectrophotometric analysis. Multiple sequences were used because~     the nomogram comparing the L/M signal ratio is linear over only a small concentration of~     tissue iron.~   "
219249|NCT00689169|"~     The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen~     utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined~     with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to~     65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma~   "
219250|NCT00689156|"~     The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and~     overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin~     and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast~     cancer.~   "
219251|NCT00689143|"~     This exploratory study is the first study in a clinical program where the overall objective~     is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for~     the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and~     putative bone regeneration properties. Periodontitis is the major cause of tooth loss in~     people over 35 years of age. An effective pharmacological treatment is today lacking and the~     actual therapy would represent a new treatment option for the large patient group suffering~     from the disease.~   "
219252|NCT00689130|"~     The present study is designed to compare prospectively whether sBIS, sEMG, or CVI variability~     (brain monitoring) can be used to predict unwanted intraoperative responses (high blood~     pressure, fast heart rate, tearing, etc.) to stimulation (pain) and to determine whether~     these intraoperative findings are related to patient-assessed postoperative pain scores.~      The hypothesis is that increases in these variability measures are associated with increased~     probability of unwanted responses. If confirmed, these variability measures may help~     anesthesia providers by highlighting periods of inadequate analgesia (pain relief).~   "
219253|NCT00689117|"~     The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in~     subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel,~     Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.~   "
219254|NCT00689104|"~     The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron~     against placebo and compare the efficacy and safety with active comparator in patients with~     symptoms of overactive bladder.~   "
219255|NCT00689091|"~     Awareness during anesthesia is a problem receiving increased attention by patients,~     clinicians, and the general public. The incidence of intraoperative awareness has been~     reported to be between 1-2/1000 cases, but recent data suggest that this may be an~     overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of~     assessing depth of anesthesia that has been shown in one study to reduce the incidence of~     awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of~     Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in~     the high-risk population was 138, with an associated cost of approximately US$2200. Since the~     NNT and the associated cost of treatment would be much higher in the general population, the~     efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be~     clearly established. Furthermore, recent data suggest that the BIS may not be useful in the~     high-risk population. The investigators propose a prospective, randomized, controlled trial~     comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of~     anesthetic depth.~   "
219256|NCT00689078|"~     The purpose of the study is to determine whether prednisolone acetate 1% ophthalmic~     suspension is effective in preventing signs and symptoms of allergic conjunctivitis in~     comparison with prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2%~     ophthalmic suspension and placebo in a modified conjunctival allergen challenge (CAC) model.~   "
219257|NCT00689065|"~     Rationale: CALAA-01 is a targeted therapeutic designed to inhibit tumor growth and/or reduce~     tumor size. The active ingredient in CALAA-01 is a small interfering RNA (siRNA). This siRNA~     inhibits tumor growth via RNA interference to reduce expression of the M2 subunit of~     ribonucleotide reductase (R2). The CALAA-01 siRNA is protected from nuclease degradation~     within a stabilized nanoparticle targeted to tumor cells.~      PURPOSE: This phase I trial will:~        -  Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CALAA-01 when~          administered intravenously to patients with relapsed or refractory cancer.~        -  Characterize the pharmacokinetics (PK) of CALAA-01 after intravenous administration.~        -  Provide preliminary evidence of efficacy of intravenous CALAA-01 by evaluating tumor~          response.~        -  Recommend a dose of intravenous CALAA-01 for future clinical studies.~        -  Evaluate immune response, by measuring antibody and cytokine levels, and the effect of~          intravenous CALAA-01 on complement.~   "
219258|NCT00689052|"~     The primary objective of this study is to assess the efficacy and safety of an~     extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment~     of fibromyalgia.~      The objective of the open-label phase is to assess the safety profile and effect of~     Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.~   "
219259|NCT00689039|"~     The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how~     the medication is metabolised by the body (how it is taken up, distributed, and how it~     disappears from the body). The study is performed in healthy volunteers.~   "
219260|NCT00689026|"~     A large population-based study has shown diabetes to be an independent risk factor for colon~     cancer compared to the general population. Thus, the completion of an adequately prepped~     colonoscopy is requisite in providing diabetics with adequate colon cancer screening.~      Recent data has shown that diabetic patients have poorer response to bowel cleansing compared~     to non-diabetics (with a standard PEG prep, only 62% of diabetic patients had their~     colonoscopy preps rated as good or better vs. 97% of normal patients, p<0.001). This may be~     due to the fact that a majority of diabetic patients report constipation as a common~     gastrointestinal complaint.~      We postulate that lubiprostone (Amitiza), in combination with PEG, will have additional~     efficacy over standard PEG preparation, and provide optimal safe and effective colonic~     cleansing for diabetics.~   "
219261|NCT00689013|"~     The purpose of this study is to determine whether pharmacist-driven patient interventions can~     have an effect on the number of herpes zoster (Zostavax) vaccinations given in a community~     pharmacy setting.~   "
219262|NCT00689000|"~     This is an open-label, non-randomised, multi-centre phase I-II study of CHR-2797 administered~     orally once a day. The study involves two distinct phases:~        -  Phase I: an open-label, dose-escalating phase of the study to explore the safety,~          tolerability, and pharmacokinetics (PK) of CHR-2797.~        -  Phase II: the recommended dose level of CHR-2797, as determined in phase I, will be~          administered to a further cohort of approximately 40 patients to determine whether~          CHR-2797 has sufficient biological activity against the disease(s) under study.~   "
219263|NCT00688987|"~     Replacing glucocorticoid in a dose dependent manner (including doses within the physiological~     range) to subjects with adrenal insufficiency will increase visceral fat accumulation~     independently of total fat mass.~   "
219264|NCT00688974|"~     Wight loss surgery provides good glycemic control in type 2 diabetes. The technique of~     Roux-en-Y gastric bypass is more effective than the Adjustable Gastric Band on weight~     loss.~      This longitudinal cohort study will compare the effectiveness of the Roux-en-Y gastric bypass~     and Adjustable Gastric Banding on glycemic control in type 2 diabetes and explore the~     responsible mechanisms.~      The evaluation will be made preoperatively and 1 year later as assessed by the decline in~     HbA1c. An evaluation will also be carried out after a weight loss of 10% to indicate whether~     the observed difference is independent of weight loss.~   "
219266|NCT00688948|"~     Multiple Sclerosis is often associated with severe functional deficits resulting in a range~     of progressive impairments. Approximately 80% of patients have bladder symptoms at the time~     of diagnosis and up to 97% will have bladder symptoms during the course of the disease. To~     date, the vast majority of treatment has been centered on the use of medications to control~     bladder spasms and the use of catheters to help patients empty the bladder. There have been~     very few studies looking at medications like Alfuzosin that may help in controlling bladder~     symptoms in Multiple Sclerosis. Alfuzosin has been shown to significantly improve voiding~     symptoms and bladder emptying in patients with prostatic enlargement. There have been no~     controlled studies yet to determine whether this treatment helps patients with Multiple~     Sclerosis. The purpose of this study is to determine if Alfuzosin improves bladder symptoms~     and quality of life in patients with Multiple Sclerosis.~   "
219267|NCT00688935|"~     The primary goal of this study is to identify the presence of desynchronized circadian~     rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples,~     and to rule out any primary sleep disorders.~   "
219268|NCT00688922|"~     The purpose of the Study is to determine whether early treatment with pravastatin can reduce~     adverse cardiac events in patients with acute myocardial infarction and minimally to mildly~     elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.~   "
219269|NCT00688909|"~     This study will evaluate whether patients who are intolerant and discontinue anastrozole due~     to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking~     letrozole~   "
219270|NCT00688896|"~     The purpose of this study is to evaluate the effect of two dose levels of JTT-705 when~     co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP~     activity and to document short term safety.~   "
219271|NCT00688883|"~     To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.~   "
219272|NCT00688870|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal~     conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.~   "
219273|NCT00688857|"~     This is a single-center, randomized, open-label, multi-dose crossover study assessing the~     pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy~     volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of~     diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy~     volunteers under fed conditions. Secondary objectives are to assess diazoxide choline~     pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and~     tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets~     in healthy volunteers.~   "
219274|NCT00688844|"~     HYPOTHESIS: The investigators hypothesize that KuvanTM therapy could influence nutritional~     and body composition parameters and neurotransmitter concentrations in pediatric and adult~     PKU subjects.~      SUMMARY: Though the investigators know that KuvanTM lowers blood Phe levels and improves~     tolerance for natural protein in at least half of the PKU (Phenylketonuria) patient~     population, investigators do not know the full effects this medicine will have on the~     patient's diet, or what impact the medicine or diet changes will have on the body composition~     or nutrient status of PKU patients. Since KuvanTM may also help the body produce~     neurotransmitters, investigators also want to find out if taking KuvanTM changes~     neurotransmitter levels in PKU patients, and if PKU patients who are benefitting from KuvanTM~     feel less stigmatized and have a better outlook on life as a result of the treatment.~      Therefore, the research study has several objectives. These are to investigate the impact~     KuvanTM therapy has on (1) body composition parameters of PKU patients: such as lean body~     mass, percent body fat, bone density, weight gain, and growth (2) dietary changes, and the~     effect of those changes, on intake of calories and essential nutrients (3) changes in blood~     biomarkers of certain nutrients (4) blood and urine neurotransmitter levels, since these~     changes could indicate improved neurological functioning, (5) and quality of life of PKU~     patients, who may feel less burdened due to the dietary freedom KuvanTM provides.~   "
219275|NCT00688831|"~     The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the~     medication is metabolised by the body (how it is taken up into the body, distributed around~     the body and disappears from the body~   "
219276|NCT00688818|"~     This multi-centred study will be conducted at three centres. The design will be a randomized,~     placebo-controlled, parallel-group one. This investigation will evaluate the efficacy of~     add-on Quetiapine XR (extended release) treatment for patients who meet diagnostic criteria~     for depressive disorders and one or more comorbid anxiety disorder.~   "
219277|NCT00688805|"~     Background:~        -  Relapse to drug abuse is thought to result, in many cases, from exposure to cues that~          trigger drug-related memories or emotional associations for example, the association~          between the sight of a crack pipe and a set of responses such as rapid heartbeat and~          desire for cocaine. This type of memory is reconsolidated (actively re-stored) each time~          it is reactivated; however, the reconsolidation process can be disrupted by the drug~          propranolol, which weakens the link between that memory and an emotional response.~        -  Propranolol is traditionally used to treat high blood pressure and other heart-related~          conditions. Researchers are interested in studying whether propranolol disrupts~          reconsolidation of drug-cued memories in individuals who are addicted to cocaine.~      Objectives:~      - To examine whether propranolol can interfere with reconsolidation of cocaine-related~     memories and reduce cravings and drug use in substance abusers.~      Eligibility:~      - Individuals between 18 and 55 years of age who are current cocaine users enrolled in a~     methadone treatment program.~      Design:~        -  The study will involve four long sessions (visits 1, 4, 6, and 14) and 10 short~          sessions. The short visits will be for monitoring of participants use of drugs and~          alcohol; the longer visits will involve more tests and lab sessions. Participants will~          be randomized to either the propranolol or placebo group.~        -  The long sessions will involve the following procedures:~        -  An interview session to develop a personalized drug script/cue set.~        -  A two-hour intervention session with baseline measures, drug administration (propranolol~          or placebo), and two script-guided imagery sets. This is the only administration of~          propranolol during the study.~        -  Two follow-up test sessions, 1 and 5 weeks after the intervention session.~        -  Participants will make brief visits to our outpatient clinic for twice-weekly monitoring~          of ongoing drug use via urine screens and self-report, starting 1 week before the~          intervention session and ending 5 weeks later.~   "
219278|NCT00688792|"~     A questionnaire will be used in order to find out the reasons for poor adherence for~     long-term treatment in children with asthma. The hypotheses is maternal factors including the~     knowledge that asthma is a chronic disease and fear to administer inhaled steroids are major~     obstacles for appropriate adherence.~   "
219279|NCT00688779|"~     Investigate safety/tolerability after a single dose intranasal administration of AZD8848~     comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients~     out of season~   "
219280|NCT00688766|"~     IPI-504-06 is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to~     evaluate the efficacy and safety of IPI-504 as compared to placebo in patients with~     metastatic and/or unresectable GIST following failure of at least imatinib and sunitinib.~      Approximately 195 patients will be randomized using a 2:1 ratio to receive either IPI-504~     (N=130) or placebo (N=65). Upon unblinding, patients receiving either IPI-504 or placebo may~     receive IPI-504 in the open-label portion of the study if defined inclusion criteria are met.~      Early and frequent imaging timepoints (Weeks 2, 5, 8, 14 and every 6 weeks thereafter) are~     incorporated into this study to capture progression events and limit patient exposure to~     ineffective agents.~   "
219281|NCT00688753|"~     To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line~     treatment of patients with metastatic papillary carcinoma of the kidney.~   "
219282|NCT00688740|"~     The purpose of this study was to compare disease-free survival after treatment with docetaxel~     in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with~     doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary~     lymph nodes.~   "
219283|NCT00688727|"~     The purpose of this study is to determine whether adults with disoociative (psychogenic~     non-epileptic) seizures receiving cognitive behavioural therapy (CBT) show a greater~     reduction in seizures and health service use and greater improvement in employment status and~     overall psychosocial functioning than patients who receive standard care.~   "
219284|NCT00688714|"~     AZD6482 is a new drug substance aiming to prevent blood clots which may arise in~     atherosclerotic blood vessels and cause myocardial infarction or stroke. This is the first~     study with AZD6482 in humans. The primary aim for this study is to evaluate the safety and~     tolerability of AZD6482 in healthy human volunteers. How the substance is metabolised and~     eliminated from the body will also be studied. This will be done by comparing the effect of~     single ascending doses of AZD6482 to placebo (inactive substance).~   "
219285|NCT00688701|"~     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in~     comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period~     of 12 weeks of treatment.~      The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on~     glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin~     (HbA1c) reduction (absolute change) at Week 12.~      Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on~     glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration~     regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour~     postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and~     tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.~   "
219286|NCT00688688|"~     The study is intended to test the safety, tolerability, efficacy of two doses of long term~     once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and~     secondly to compare these with active comparator.~   "
219287|NCT00688675|"~     Document how Swiss GPs allocate their GERD patients to the three GERD patient segments~     (according to King et al.) and how treated GERD patients are affected by their GERD treatment~   "
219288|NCT00688662|"~     The Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction(SOD) study~     (EPISOD) is a randomized sham-controlled study of biliary and pancreatic sphincterotomy as~     treatment for patients with pain after cholecystectomy fitting the criteria for sphincter of~     Oddi dysfunction type III.~   "
219289|NCT00688649|"~     Disease-related malnutrition is common across healthcare settings in the UK and if left~     untreated, may have severe consequences. One of the strategies commonly used to combat~     malnutrition is the use of oral nutritional supplements (ONS). However, there is uncertainty~     about the optimal way of delivering ONS to patients to maximize compliance and nutrient~     intake.~      This randomised study will investigate the effect of different modes of delivery (ad libitum~     versus instructions on timing/serving volume) of ONS used in addition to the diet on total~     nutrient intake, compliance, nutritional status and outcome in participants at risk of~     malnutrition.~      Participants will be randomised to receive one of two ONS (high energy or standard) for 4~     weeks in addition to food, either taken 'Ad libitum', or according to instruction on what to~     take and when. The primary outcome measure is nutrient intake. Secondary outcome measures~     include compliance and acceptability of ONS, appetite, anthropometry, muscle strength,~     quality of life and gastro-intestinal tolerance.~   "
219290|NCT00688636|"~     A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's~     disease 12 months after curative, resective ileal or ileocolonic surgery in patients~     receiving post-operative infliximab or placebo~   "
219291|NCT00688623|"~     To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line~     treatment of patients with metastatic papillary carcinoma of the kidney.~   "
219292|NCT00688610|"~     Antibiotics in patients with acute respiratory tract infections in primary care in~     consideration of procalcitonin as additive parameter.~      The purpose of this study is to compare the ordinary manner of antibiotic- prescription with~     the prescription in consideration of procalcitonin-value in patients with acute respiratory~     tract infections.~   "
219293|NCT00688597|"~     The main purpose of this study is to determine the safety and tolerability of three different~     doses of AT2220 in people affected by Pompe disease. The study will also evaluate the effects~     of AT2220 on functional parameters in Pompe disease.~   "
219294|NCT00688584|"~     The major objective of this proposal is to conduct a randomized controlled trial of an~     ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects~     will be recruited via a telephone survey which will collect baseline data. The households of~     half of the subjects will receive the pamphlet as unaddressed ad mail shortly thereafter.~     Follow-up interviews will be conducted, by telephone, three and six months after the mailing~     of the pamphlets.~      Hypothesis 1: Respondents from households who receive the pamphlet will display significantly~     improved drinking outcomes at the three-month and six-month follow-ups as compared to~     respondents from households in the no intervention control condition.~      Hypothesis 2: More calls will be received on a help-line listed on the pamphlet (and~     advertised elsewhere) from residents of households who receive the pamphlet as compared to~     residents from households who do not receive the pamphlet.~      Hypotheses 3 - 6 deal with mediator and moderator hypotheses, exploring the role of perceived~     risk, perceived drinking norms, and drinking for social reasons.~   "
219295|NCT00688571|"~     This non-randomized, prospective, interventional observational multi-center study is designed~     to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary~     Valve (TPV) in the post market environment over a period of five years after transcatheter~     implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life~     of implanted subjects will be assessed over five years.~   "
219296|NCT00688558|"~     The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of~     JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with~     low HDL~   "
219297|NCT00688545|"~     This multi-center observational Registry will collect long-term safety data on patients~     treated with celecoxib or non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) as~     used in clinical practice for the treatment of Juvenile Idiopathic Arthritis (JIA).~   "
219298|NCT00688532|"~     A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate~     cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the~     general population will be followed- up for two outcomes; CHD including acute myocardial~     infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be~     validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in~     the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD~     and HF associated with the use of bicalutamide compared to non-use will be estimated.~   "
219299|NCT00688519|"~     The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with~     plaque-type psoriasis.~   "
219300|NCT00688506|"~     Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians~     once conventional therapies fail.~      We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in~     men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo~     therapy has a significant effect on brain activity detectable by functional MRI.~   "
219301|NCT00688493|"~     The main purpose of this study is to examine the effect of dapagliflozin on electronic~     measures of heart beats in healthy males~   "
219302|NCT00688480|"~     Cardiovascular related disease is the main cause of death in patients with kidney disease,~     and oxidative stress is thought to be a major contributor by promoting thickening of the~     heart muscle and stiffening of the arteries. Allopurinol, a drug used safely in the treatment~     of gout for many years, has been found to dramatically reduce oxidative stress. It is~     therefore hoped that it also reduce the thickened heart muscle and stiffened arteries. If it~     did, it is likely to reduce the appallingly high cardiac death rate in this group of kidney~     disease patients.~   "
219303|NCT00688467|"~     Evaluation of treatment in participants with mild asthma.~   "
219304|NCT00688454|"~     The study explores efficacy and safety of the lipid-lowering therapy with CRESTOR in~     statin-naive patients and in patients with previously unsuccessful statin therapy. This study~     was designed to investigate the dynamic of the lipid parameters and therapy tolerability~     during 8-10 weeks treatment with CRESTOR~   "
219305|NCT00688441|"~     The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the~     treatment of Seasonal Allergic Rhinitis~   "
219306|NCT00688428|"~     The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is~     pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet~   "
219307|NCT00688415|"~     This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may~     stimulate the immune system to help fight cancer. The purpose of the study is to assess the~     safety of the investigational drug and to identify the highest dose that is well-tolerated.~     The pharmacology of VTX-2337 will also be evaluated.~   "
219308|NCT00688402|"~     The purpose of the study is to compare different formulations of AZD3355 in regard to~     possible adverse events such as sensations of numbness, tinglings and heat in the skin.~   "
219309|NCT00688389|"~     The study will collect the blood samples from 350 healthy persons and 350 persons infected~     with dengue fever.~   "
219310|NCT00688376|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil~     in children with persistent attention impairment that is present at least 12 months after the~     completion of cancer treatment.~   "
219311|NCT00688363|"~     The purpose of this randomized, prospective trial is to determine wether (a) a once weekly~     glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated~     haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic~     patients on conventional insulin treatment.~   "
219312|NCT00688350|"~     The purpose of this study is to test an intervention to help older adults do a better job of~     following blood pressure medication regimens prescribed by their health care providers.~   "
219313|NCT00688337|"~     In the current study FDG (Fluorodeoxyglucose) uptake, FLT uptake~     (F18-Fluoro-3'-deoxythymidine) and their ratios will be correlated with the risk score~     results of the Oncotype gene-expression assay in patients with clinically negative nodal~     disease planned for surgical removal of the tumor.~   "
219314|NCT00688324|"~     NMDA receptors are brain receptors that are stimulated by glutamate. Poorly functioning NMDA~     receptors are thought to be involved in the pathology of schizophrenia. This hypothesis is~     based on the observation that PCP, which blocks the NMDA receptor, produces symptoms and~     cognitive impairments similar to schizophrenia. Efforts to enhance the function of the NMDA~     receptor with glycine and D-cycloserine have met with limited success. An alternative~     approach would be to use the drug acamprosate.~      Acamprosate, FDA-approved for maintenance of sobriety after detoxification from alcohol,~     seems to act through modulation of the NMDA receptor. In the lab, acamprosate has been noted~     to act as an antagonist when the NMDA receptors are maximally stimulated but as an agonist~     when NMDA receptor stimulation is minimal. This smart drug action makes acamprosate~     appealing for use in schizophrenia. If acamprosate works as a smart drug in patients, then we~     would predict that it would enhance the function of NMDA receptors in schizophrenia and~     improve cognition and the symptoms of the illness. Additionally, acamprosate seems to~     modulate the NMDA receptor in novel ways distinct from glycine and D-cycloserine.~      We will also see if the response to acamprosate differs based on whether participants do or~     do not have a past history of alcohol use disorders.~   "
219315|NCT00688311|"~     The goal of this study is to test the hypothesis that daily ingestion of a 'synbiotic' for 4~     weeks will improve intestinal function, ease immune system overactivation, and increase blood~     CD4 count in HIV-infected individuals. A 'Synbiotic' is a mixture of probiotic bacteria and~     dietary fiber.~   "
219316|NCT00688298|"~     The pre-pubic approach of the tension free vaginal sling placement is a new approach in the~     treatment of SUI. The retropubic approach of the tension free vaginal sling is the standard~     method of device delivery; in addition a suprapubic and a transobturator approach are~     alternative methods of delivery. All of these delivery approach systems are intended to place~     the mesh tension free in the mid-urethra.~      There are currently no studies that investigate the pre-pubic delivery approach in the United~     States. However, the largest series of cases in Europe using the pre-pubic system was done by~     Ulmsten (published in the European Journal of Obstetrics and Gynecology and Reproductive~     Biology) 107 (2003) 205-207, titled  Pre-Pubic tension free vaginal tape application: an~     alternative to classic tension free vaginal tape application in selected patients with SUI.~      The primary objective of this study is to evaluate the feasibility of using a pre-pubic~     approach to the placement of a mid-urethral vaginal mesh.~        -  Demonstrate the mesh can be properly placed in the mid-urethra using a pre-pubic~          approach;~        -  Assess the performance of the delivery device by measuring the ease of use, technical~          complexity, and instrument difficulties~   "
219317|NCT00688285|"~     To determine whether the use of educational sessions and computerized clinical reminders can~     improve primary care doctors' delivery of care to CKD patients compared to educational~     sessions alone. Hypothesis: Clinical reminders will improve the care delivered to CKD~     patients~   "
219318|NCT00688272|"~     This study is designed to investigate the safety profile and the photoirritant potential of~     eltrombopag in healthy subjects. The study is placebo- and positive controlled, randomized,~     parallel group with three treatment arms: eltrombopag (75 mg QD), placebo, and a positive~     control (ciprofloxacin, 500 mg BID). Eltrombopag will be administered in a double-blind~     fashion with respect to placebo and the positive control, ciprofloxacin, will be administered~     under observer-blinded conditions. Twelve to fifteen subjects will be recruited into each~     arm, to assure total enrollment of 36 evaluable subjects. The primary endpoint is the~     photosensitizing potential of eltrombopag as measured by photoirritant index (PI) and change~     in minimum erythemal dose (MED) in comparison with placebo.~   "
219319|NCT00688259|"~     This is a study comparing the benefits of two types of individual psychotherapy~     (cognitive-behavioral therapy for psychosis and supportive therapy) in symptomatic Veteran~     outpatients diagnosed with schizophrenia or schizoaffective disorder. Treatment lasted~     approximately 6 months, with outcome data on symptoms, functioning, and distress levels~     collected at baseline, post-treatment, and 6 months post -treatment follow-up.~   "
219320|NCT00688246|"~     RATIONALE: Learning about the effect of exemestane on bone mineral density in postmenopausal~     women at increased risk of breast cancer may help plan treatment, decrease the risk of broken~     bones, and help patients live more comfortably.~      PURPOSE: This research study is measuring bone mineral density in postmenopausal women at~     increased risk of developing breast cancer who are receiving exemestane on clinical trial~     CAN-NCIC-MAP3.~   "
219321|NCT00688233|"~     For improving the appearance of protruded upper front teeth when lower front teeth may touch~     palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be~     used.~   "
219322|NCT00688220|"~     The purpose of this research is to determine whether a new type of fabric, Celliant, can~     reduce elbow and wrist pain associated with chronic medical conditions such as carpel tunnel~     syndrome, arthritis or tennis elbow and whether it can increase blood flow and oxygenation~     levels in the arms and hands after wearing the material.~   "
219323|NCT00688207|"~     The present pharmacokinetic study is designed to assess the pharmacokinetics of RSG XR as~     monotherapy in patients with mild Alzheimer's disease (AD) as such information will not be~     obtained from the current phase III trials . The study aims to enroll fourteen patients~     (seven of each APOE genotype). Each patient will receive a single oral dose of 4mg of RSG XR~     in the morning under fasted conditions and PK samples will be taken up to 36h.~   "
219324|NCT00688194|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     fulvestrant and exemestane, anastrozole, or letrozole may fight breast cancer by blocking the~     use of estrogen by the tumor cells and by lowering the amount of estrogen the body makes.~     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It is not yet known whether fulvestrant is more effective with or without lapatinib~     and/or aromatase inhibitor therapy in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying fulvestrant with or without lapatinib~     and/or aromatase inhibitor therapy to compare how well they work in treating postmenopausal~     women with metastatic breast cancer that progressed after previous aromatase inhibitor~     therapy.~   "
219325|NCT00688181|"~     Registry to gather information about the long term use of the Prefyx PPS System which~     utilizes a pre-pubic surgical approach (device is to be placed in front of the pubic bone)~     for the treatment of SUI. No additional procedures are required beyond the physician's~     standard of care.~   "
219326|NCT00688168|"~     The goal of this research study is to learn about the pain and/or other symptoms that~     patients may experience either while you are being monitored by your doctor before a decision~     is made to start you on treatment for your MM, or during and after treatment for MM, and how~     these symptoms may affect therapy. A second goal is to learn how differences in genes may~     affect the symptom burden from cancer and cancer therapy.~   "
219327|NCT00688155|"~     The purpose of this pilot study is to develop and conduct well-designed trial to assess~     whether a multi-factorial intervention involving physical activity and cognitive training~     reduces the risk of significant cognitive decline in older individuals.~   "
219328|NCT00688142|"~     The investigators hypothesize that in patients with shift work sleep disorder, armodafinil~     will specifically increase brain activity in the frontal cortex parallel with improvements in~     deficits of fundamental mechanisms of attention.~   "
219329|NCT00688129|"~     The KITS project is a 5-year randomized trial to evaluate a program designed to enhance~     academic and social-emotional aspects of school readiness for foster preschoolers.~   "
219330|NCT00688116|"~     An open-label dose escalation study of patients with solid tumors treated with STA-9090~     (ganetespib)~   "
219331|NCT00688103|"~     Multi-center, parallel-group, randomized, open control study. All patients will be selected~     to two treatment groups.~        1. Etanercept alone treatment group (25mg, twice/week, s.c.)~        2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)~   "
219332|NCT00688090|"~     A dose comparison of a multi-component active immunotherapy designed to stimulate an immune~     reaction to specific tumor associated antigens which are highly expressed on melanomas.~   "
219333|NCT00688077|"~     Introduction:~      Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an~     FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important~     regulator of FGF-23 production and secretion in healthy humans.~      Aim:~      In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.~      Study Design:~      placebo-controlled, cross-over study~      Method:~        -  All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml~          NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously~        -  On both occasions frequent bloodsampling will take place, out an indwelling catheter in~          de forearm vein.~        -  Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes~        -  Mealtimes: Calcium and Phosphate intake standardized on both occasions~        -  All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics,~          San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that~          measures only intact FGF-23~        -  Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca,~          albumin, PO4, PTH, 25-OHD and 1,25-OHD~      Endpoint:~      A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of~     calcitonin 200 IU.~   "
219334|NCT00688064|"~     The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide~     (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to~     Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg~     Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens~     will also be evaluated.~   "
219335|NCT00688051|"~     Nonadherence to treatment regimes among patients with cystic fibrosis (CF) is well documented~     in the literature. Unfortunately, few interventions have been successful at improving~     adherence rates in this patient population. Within the pediatric population, specifically~     adolescents, attitude toward treatment directly effects adherence to treatment. Changing~     attitude includes making conscious decisions regarding adherence or non-adherence and should~     include an understanding of what outcomes will likely result from nonadherence.~      This study will determine if attitudes can be enhanced and adherence to treatment regimen~     improved in Cystic Fibrosis (CF) adolescent patients by using a simulation game My Life with~     CF . The target population is CF patients ages 12-21 years. Attitudes will be assessed~     utilizing four attitude scales in CF adolescents pre and post experiencing the simulation~     game. In the simulation game, patients make life decisions, including CF therapy decisions,~     using a fictional character diagnosed with CF. The game has been designed to help players~     understand the long-term effects of health care choices. Data from this pilot study will~     assess changes in attitudes and reported changes in adherence.~   "
219336|NCT00688038|"~     The goal of this clinical research study is to learn how well magnetic resonance thermal~     imaging (MRTI) can check the amount of tumor being destroyed using a therapy called laser~     ablation (a procedure that uses lasers to create heat that is designed to destroy cancer~     cells).~   "
219337|NCT00688025|"~     The present protocol will utilize simultaneous recording of brain activity during attention~     and memory tasks in insomnia participants after ramelteon vs. zolpidem vs. placebo~     administration. The investigators hypothesize that amplitudes of associated with memory will~     be unchanged by ramelteon, whereas zolpidem will significantly reduce brain activity~     associated with stimulus processing as evidenced by abnormal reduction in the amplitude of~     specific brain regions relative to placebo.~   "
219338|NCT00688012|"~     A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy~     men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.~   "
219339|NCT00687999|"~     The influence of insulin sensitivity and glucose tolerance on the effects of antiviral~     therapy for HCV remains unclear. The aim of the present study was (1) To elucidate the~     clinical and virological factors associated with sustained viral response in patients with~     combination therapy with PEG-IFN and ribavirin. (2) To clarify the influence of diabetes~     mellitus (DM), impaired glucose tolerance test (IGT) and insulin resistance (IR) on the HCV~     response to combination therapy with PEG-IFN and ribavirin. (3) To test the influence of~     combination therapy on HOMA IR~   "
219340|NCT00687986|"~     The standard treatment for an early stage I lung cancer is surgery. However, surgery can be~     associated with complications and long-term impairment of the quality of life of patients.~     Stereotactic radiotherapy (SRT) is a outpatient technique which allows for local control~     rates that are comparable to those achieved using surgery. In this study, patients with stage~     IA non-small cell lung cancer will be randomized to either surgery or SRT in order to study~     the local and regional tumor control, quality of life and treatment costs at 2- and 5-years.~   "
219341|NCT00687973|"~     Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination~     amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than~     an atenolol/amlodipine combination based regimen.~   "
219342|NCT00687960|"~     This study tested the effects of resistant starch type 4 on blood sugar and hunger in young~     adults with Type 2 diabetes.~   "
219343|NCT00687947|"~     The aim of the present study is to explore the importance of migraine phenotype on the~     headache/migraine responses after CGRP in FHM-patients, MA-patients and healthy volunteers.~   "
219344|NCT00687934|"~     An open-label dose escalation study of patients with solid tumors treated with STA-9090~     (ganetespib)~   "
219369|NCT00687596|"~     The purpose of this study is to determine whether TAC-101 as a second line therapy for~     patients who received Sorafenib as first line therapy is effective in slowing tumor activity~     in patients with advanced hepatocellular carcinoma. The study is also looking at the safety~     of TAC-101 following treatment with Sorafenib.~   "
219489|NCT00686010|"~     To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C~     and on the inhibition of CETP activity versus placebo, in patients presenting with mild~     dyslipidaemia. These objectives will be tested after 4 weeks of treatment.~   "
219345|NCT00687921|"~     18F-fluoride is a positron-emitting bone-seeking agent with favorable pharmacokinetic~     properties. Its uptake mechanism resembles that of 99mTc-MDP. After IV administration,~     18F-fluoride diffuses through the bone capillaries into the bone extracellular fluid (ECF).~     Its plasma clearance is more rapid than that of 99mTc-MDP and its single-passage extraction~     efficiency is higher. The fast blood clearance of 18F-fluoride results in a better target-~     to- background ratio. Bone uptake of 18F-fluoride is two-fold higher than that of 99mTc-MDP.~     Combining the favorable pharmacokinetic characteristics of 18F-fluoride with the high~     performance of PET technology, 18F-fluoride is a valuable imaging modality of the skeleton.~      There are only few manuscripts on the role of static 18F-fluoride PET for detection of~     lesions in patients referred for non-oncologic indications The purpose of the study is to~     prospectively assess the added value of Fluoride PET/CT in the clinical setting of acute knee~     injury. The findings of Fluoride PET/CT will be correlated with those found on arthroscopy~     and MRI which the currently used diagnostic techniques with a high, however, not perfect~     diagnostic accuracy regarding the issue of bone injury which is a critical component on the~     long term outcome after knee injury.~   "
219346|NCT00687908|"~     The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide~     2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously~     treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline~     Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.~   "
219347|NCT00687895|"~     General objective: To improve the quality of fever case management in children in government~     health facilities in Tanzania Hypothesis:The training of health workers, as well as~     provision, training and use of microscopes for malaria diagnosis will improve the treatment~     of clinical episodes of fever in children while reducing the amount and costs of drugs~   "
219348|NCT00687882|"~     The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to~     evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3~     months) anticoagulation in children with first-episode acute venous thrombosis. The first~     stage of the trial has consisted of a pilot/feasibility component, which then continues as~     the definitively-powered trial.~   "
219349|NCT00687869|"~     Primary objective of this study is to determine whether a case management of stroke patients~     after discharge to home or to nursing home results in improving physical and cognitive~     capacity one year after discharge.~   "
219350|NCT00687856|"~     Heart failure is a progressive disorder in which the weakened heart is not able to~     efficiently pump blood throughout the body. When the body's cells do not receive enough~     blood, this can result in fatigue, shortness of breath, and difficulty carrying out daily~     activities. The left ventricular assist device (LVAD) is a device that is used to provide~     mechanical circulatory support to patients with end-stage heart failure who are awaiting~     heart transplants. Although LVAD support helps maintain the pumping ability of the heart and~     dramatically improves heart failure symptoms, the quality of life with LVAD support is far~     from ideal. It has been shown that LVAD support in selected patients may restore the failing~     heart enough to eliminate the need for heart transplant, but more information is needed to~     assess heart recovery and to guide weaning of LVAD support. Using data collected from~     patients who have undergone LVAD implantation, this study will attempt to better assess heart~     recovery and to generate criteria for identifying patients eligible for the removal of LVAD~     support.~   "
219351|NCT00687843|"~     Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric~     cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using~     TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.~   "
219352|NCT00687830|"~     The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon~     colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day~     of the colonoscopy will be compared with that given on the morning of an afternoon~     colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are~     blinded to the randomization process.~   "
219353|NCT00687817|"~     The primary objective of this study is to determine the overall response rate (complete~     response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel~     in patients with previously untreated locally advanced or metastatic non-small cell lung~     cancer.~   "
219354|NCT00687804|"~     CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab~     (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in~     patients with visual impairment due to diabetic macular edema.~      CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12~     month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as~     symptomatic treatment for visual impairment due to diabetic macular edema.~   "
219355|NCT00687791|"~     The objective of this study is to determine the safety and effectiveness of the OculusGen™~     (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy surgery. The primary~     endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint~     is to prove the safety via the incidence of complications and adverse events.~   "
219356|NCT00687778|"~     F18-FDG is the widely used PET tracer in the routine practice of oncologic disease imaging~     using the technology of PET-CT. However, FDG-avidity is a characteristic of the individual~     tumor. There are various types of human malignancies, which are not taking FDG in access. In~     these cases FDG is not a sensitive tracer of imaging. In search for other tumor PET tracers,~     C11-Acetate has been shown recently in a few early studies to have a potential value in~     imaging of non-FDG-avid tumors.~      The purpose of the current study is to assess the role of 11C-acetate PET in various tumors,~     which often are not detected by 18F-FDG and were not widely assessed until now.~   "
219370|NCT00687583|"~     A breathing tube, which is used to secure the airway and allow ventilation of the lungs~     during general anaesthesia, is inserted into the windpipe either through the nose or mouth.~     In children, different formulas exist to determine the appropriate size of the tube according~     to age, and how far it should be advanced into the airway. Head movement can alter the~     position of the breathing tube, making it go in or come out too far. Different types of~     breathing tubes may also differ in their change of position with head movement. The aim of~     this study is to assess the accuracy of the formulae commonly used in our institution for~     depth of breathing tube placement, and to measure the degree of tube displacement on head~     movement with different types of tubes.~   "
219357|NCT00687765|"~     The phase I portion of study is designed to determine the Maximum Tolerated Dose (MTD) of~     BSI-201 with two clinically relevant dosing regimens of temozolomide (TMZ). Secondary~     objectives in the phase I trial include determining the PK of BSI-201 in malignant glioma~     patients and correlating BSI-201 PK with degree of PARP-1 inhibition. A safety run-in will~     confirm the safety of BSI-201 added to standard TMZ and radiation therapy and the phase II~     portion of the study will assess the efficacy and tolerability of the MTD dose of BSI-201~     with daily TMZ and radiation therapy followed by adjuvant TMZ in patients with newly~     diagnosed GBM and assess overall survival as the primary outcome measure. Information on each~     phase of the study will be listed when each phase opens for enrollment.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
219358|NCT00687752|"~     310 singleton pregnancies (22-35 weeks) enrolled into the study. We assessed sonographically~     the fetal larynx in an axial plane through the mandible and observed the fetal deglutition~     movements .~   "
219359|NCT00687739|"~     The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency~     accelerates fat gain and abdominal fat accumulation in women.~   "
219360|NCT00687726|"~     1. Simple home-based standing balance training and isometric knee extension exercise for 4~          weeks would improve functional ability and knee muscle strength of patients with knee~          osteoarthritis.~        2. The outcome of standing balance training is different from isometric knee extension~          exercise.~   "
219361|NCT00687713|"~     This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects~     with methamphetamine dependence who report using methamphetamine 29 or less days during the~     30 days prior to the start of signing consent.~   "
219362|NCT00687700|"~     Study will investigate the pharmacodynamics of a dual pharmacophore in which a combination of~     GSK961081 and Propanolol is used to give a total effect of bronchodilation.~   "
219363|NCT00687687|"~     To estimate the antitumor activity of paclitaxel, carboplatin, plus BSI-201 in patients with~     recurrent or advanced uterine carcinosarcomas.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
219364|NCT00687674|"~     RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Lenalidomide may stimulate the immune system in different ways and~     stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Sorafenib and lenalidomide may also stop the growth of cancer cells by~     blocking blood flow to the cancer. Giving sorafenib together with lenalidomide and~     dexamethasone may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when~     given together with lenalidomide and dexamethasone and to see how well they work in treating~     patients with relapsed or refractory multiple myeloma.~   "
219365|NCT00687661|"~     Kidney disease is a fundamental part of medicine because of its prominence in Western~     society. Common conditions such as diabetes, hypertension and kidney infections can all~     progress to End-Stage Renal Disease (ESRD) also known as Stage 5 chronic kidney disease (CKD~     5). Once ESRD has begun, kidney function is poor at best, thus the body is unable to~     effectively clear harmful toxins from the blood.~      A common feature of ESRD is vascular calcification, a process where blood vessels (especially~     arteries) attract deposits of the mineral calcium. Over time, these deposits harden and~     thicken in the layers of blood vessels, which limit blood flow to body tissues and can~     produce significant disease including hypertension, heart disease and stroke. Although the~     process of vascular calcification is unknown, there is mounting evidence that it is mediated~     by cellular events that are similar to those seen in bone formation with in the body~     (osteogenesis). With this point in mind, it has been suggested that agents medicine employs~     to limit excess bone formation will reduce the rate of vascular calcification in CKD Stage 5.~      This study will employ one group of drugs called bisphosphonates which have been used to~     limit bone formation. It will study their effect on vascular calcification in adult dialysis~     patients.~   "
219366|NCT00687648|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, and~     prednisolone, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Estrogen can cause the growth of breast cancer~     cells. Hormone therapy using anastrozole, letrozole, or exemestane may fight breast cancer by~     lowering the amount of estrogen the body makes. It is not yet known whether giving~     combination chemotherapy together with aromatase inhibitor therapy is more effective than~     combination chemotherapy alone in treating breast cancer.~      PURPOSE: This randomized phase II trial is studying giving cyclophosphamide, methotrexate,~     and prednisolone together with aromatase inhibitor therapy to see how well it works compared~     with cyclophosphamide, methotrexate, and prednisolone in treating postmenopausal women with~     metastatic breast cancer.~   "
219367|NCT00687622|"~     MEK111054 is a first-time-in-human, open-label study to determine recommended dose and~     regimen for the orally administered GSK1120212. The study consists of three parts. Part 1~     will identify the maximum tolerated dose. Part 2 will explore the safety, tolerability, and~     effectiveness of GSK1120212. Part 3 will determine a range of effective doses.~   "
219368|NCT00687609|"~     The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD~     (Attention Deficit/Hyperactivity Disorder) symptoms in adolescents with ADHD and comorbid~     cannabis abuse.~   "
219371|NCT00687570|"~     Traditionally bowel preparation before surgery of rectal cancer could be troublesome for~     patients especially for patients with kidney and cardio- vascular diseases, where salt and~     electrolyte balance can be a problem.~      Cleaning the bowel without complications for the patient is one of the aims for this study.~      The other aim is to see if patient nutritional status improves with nutritional drinks as a~     complement to food intake 4-6 weeks before surgery.~   "
219372|NCT00687544|"~     In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected~     with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin~     (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment~     virologic response, and sustained biochemical response), the subject morbidity rate as caused~     by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial~     infection), and the safety and tolerability of this combination therapy will be examined.~   "
219373|NCT00687531|"~     Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and~     Quality of Life impact of Mometasone Furoate dry powder 400 mcg once-daily in persistent~     mild-moderate asthmatic patients at least 12 years old.~      Protocol deviations may have occurred that resulted in quality issues associated with~     reporting of the data.~   "
219374|NCT00687518|"~     The aim of this study is to measure the variations of serum and urinary hepcidin levels~     following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is~     a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular~     efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate~     hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be~     postulated that erythropoietin could modulate hepcidin synthesis.~   "
219375|NCT00687505|"~     The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a~     new biologic treatment for cancer.~   "
219376|NCT00687492|"~     The survey will try to establish the proportion of patients on lipid-lowering pharmacological~     treatment reaching the LDL-C goals according to the third NCEP ATP guidelines, overall and by~     country.~   "
219377|NCT00687479|"~     The project objective is to validate a new indirect estimate of insulin status in both~     pregnant African-American women and Caucasian women in southern Louisiana who are at risk for~     gestational diabetes mellitus. There are racial differences in carbohydrate metabolism that~     are potentially linked to complications during pregnancy and to increased risks of obesity~     and diabetes in later life. The investigators will explore the use of indexes of insulin~     status to identify the metabolic risk profile of pregnant women which may vary by race.~     Understanding whether there are differences which vary by race may influence clinical~     screening and treatment of pregnant women.~   "
219378|NCT00687466|"~     The purpose of this study is to evaluate whether the anticipated use of glargine in CF~     patients with glucose intolerance may prevent the worsening of nutritional status and~     pulmonary function.~   "
219379|NCT00687453|"~     To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH~     insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly~     NPH insulin alone.~   "
219380|NCT00687440|"~     The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac~     toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the~     tumor response rate of this regimen. This study will be conducted in approximately 30~     centers. A total of approximately 70 to 95 subjects will be enrolled.~   "
219381|NCT00687427|"~     The purpose of this study is to investigate the extent of return to work (RTW) after~     traumatic hand injury and to identify factors that are related to RTW.~   "
219382|NCT00687414|"~     Aim of the study is to analyze the expression of genes and sequences encoding the human~     mammalian diaphanous (mDia) related formin proteins to test the hypothesis that defects in~     the mDia expression or function might drive the pathophysiology of myelodysplastic syndrome,~     acute myeloid leukemia and other myeloproliferative diseases.~   "
219383|NCT00687401|"~     Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic~     therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions~     (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The~     efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).~   "
219384|NCT00687388|"~     Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms~     from benign prostatic hyperplasia~   "
219385|NCT00687375|"~     Laparoscopic inguinal hernia repair (LIHR) has got comparable results in comparison to open~     hernia repair (OHR). Many studies have shown that LIHR gives similar results in terms of~     recurrence as compared with OHR but with the added advantage of less chances of post~     operative, pain, wound infection and early return to activity. LIHR was started using the~     transabdominal preperitoneal (TAPP) approach. Another technique of LIHR that has evolved is~     totally extra peritoneal (TEP) repair. There is only one study of 52 patients comparing TAPP~     with TEP repair and thus there is insufficient information as to which of the 2 techniques is~     better. Therefore, we have designed the present study to compare the transabdominal~     preperitoneal (TAPP) technique with totally extra peritoneal (TEP) technique of laparoscopic~     inguinal hernia repair. The advantages of TEP may include - no breach of peritoneum so less~     risk of bowel injury and post-operative adhesions. We will be using a modified technique of~     TEP repair where we will not use tacker to fix the mesh to reduce the cost of the procedure.~     On the other hand, TAPP is easy to perform and probably better for irreducible hernia. There~     is no such comparative study reported in the literature. We have been performing both TAPP~     and TEP procedures for hernia repair regularly in the department.~      RESEARCH HYPOTHESIS: TEP repair of inguinal hernia is better than TAPP repair in terms of~     reduced cost and avoidance of peritoneal incision.~      OBJECTIVE: To compare the Transabdominal preperitoneal (TAPP) vs. Totally extra peritoneal~     (TEP) techniques of laparoscopic inguinal hernia repair.~   "
219386|NCT00687362|"~     Middle Eastern subjects with moderate-to-severe chronic plaque psoriasis will be administered~     infusions of infliximab (Remicade) at 5 mg/kg of body weight at Weeks 0, 2, 6, 14, and 22.~     The safety and efficacy of infliximab monotherapy will be evaluated.~   "
223217|NCT00636948|"~     The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces~     the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of~     the rectum for cancer.~   "
219387|NCT00687349|"~     This research study is a randomized trial to evaluate a training program that is designed to~     improve the communication skills of clinicians. The training program focuses on care for~     patients with serious illnesses and their family members, and assesses effectiveness using~     patient and family outcomes. The long term goal of this research is to improve communication~     skills of doctors and nurses, thereby improving patient and family outcomes.~   "
219388|NCT00687336|"~     The goal of the study is to compare the effectiveness of empirical Helicobacter pylori~     treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in~     patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that~     empirical treatment will reduce the number of patients lost to follow-up thus improving the~     cure rates of Hp infection.~   "
219389|NCT00687323|"~     The primary objective of this study is to evaluate the safety, tolerability, and efficacy of~     temozolomide in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) participants~     who are not candidates for standard induction therapy and exhibit low MGMT expression.~   "
219390|NCT00687310|"~     The primary purpose of this study is to assess whether tailored patient education for~     patients on Symbicort® Turbuhaler® therapy improves patient satisfaction, adherence and~     Quality of Life.~   "
219391|NCT00687297|"~     It has been shown in previous studies that the ability to treat lung cancer could be~     significantly improved by not only targeting the tumor cells directly with chemotherapy, but~     also by cutting off the blood supply to the cancer cells. Blood vessels that supply the tumor~     are formed through a process called angiogenesis. Vandetanib is an investigational drug that~     acts by producing what is called an anti-angiogenic effect. An Anti-angiogenic effect is able~     to inhibit the development of new blood vessels required by tumors to survive by blocking the~     growth factors needed to form new blood vessels.~      The purpose of this study is to determine if the addition of vandetanib to a standard~     chemotherapy regimen will slow or stop the growth of the cancer for a longer period of time~     compared to the time period generally gained from the use of standard chemotherapy alone~   "
219392|NCT00687284|"~     This study is conducted in Europe. An observational study evaluating glycaemic control in~     patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in~     Slovakia.~   "
219393|NCT00687271|"~     The purpose of this study is to test the safety and effectiveness of MK6213 as compared to~     MK6213/Atorvastatin in patients (18 to 75 years) with high cholesterol.~   "
219394|NCT00687258|"~     The main purpose of this longitudinal study is to point out the effect of VitabranE on the~     ESA resistance and on the anemia observed in HD patients undergoing EPO maintenance therapy.~      As a secondary purpose we will consider the effect of VitabranE on inflammation and oxidative~     stress parameters as a function of the changes observed in the anemia parameters.~   "
219395|NCT00687245|"~     The purpose of this study is to determine the area under the plasma concentration-time curve~     (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in~     pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.~   "
219396|NCT00687232|"~     The purpose is to investigate safety and tolerability of single and multiple ascending~     inhaled doses of AZD4818 in healthy Japanese male volunteers.~   "
219397|NCT00687219|"~     The objective is to evaluate the efficacy and safety of combination therapy with~     peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks~     in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants~     who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment~     will be discontinued from therapy.~   "
219398|NCT00687206|"~     Patients with slight increase in blood pressure levels have an increased cardiovascular risk.~     In particular this has been demonstrated also in subjects with high-normal blood pressure in~     whom an exaggerated blood pressure increase, during exercise, and structural left ventricular~     abnormalities have been shown. On the other hand, the last American and European guidelines~     for management of hypertension recommend more aggressive treatment in young-middle aged~     subjects to achieve a better control of cardiovascular risk due to blood pressure increase.~     In agreement with these recommendations the investigators share the idea that a good blood~     pressure control should be achieved not only at rest, but also during psycho-physical stress~     conditions that frequently occur during daily life. On this basis, the investigators decided~     to evaluate the efficacy and tolerability of the association of valsartan and~     hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood~     pressure and first degree arterial hypertension with evidence of organ damage.~      The aim of this study is to assess if an early and adequate therapy could bring to a better~     pressure control (even during physical activity) and a regression of organ damage without~     interfering with metabolism and erectile function~   "
219399|NCT00687193|"~     To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for~     the treatment of signs and symptoms in patients with active RA who failed an adequate trial~     of therapy with at least 1 DMARD in a 12-week therapy.~   "
219400|NCT00687180|"~     A study with 20 de novo patients with autoimmune hepatitis, 10 receiving azathioprin and 10~     receiving mycophenolat mofetil.~   "
219401|NCT00687167|"~     The purpose of this study is to evaluate the relative bioavailability (rate and extent of~     absorption) of a test formulation of zonisamide capsules compared to the reference~     formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under~     non-fasting conditions.~   "
219402|NCT00687154|"~     The development or worsening of macular edema following full scatter photocoagulation is a~     well recognized occurrence. However, there is limited literature in this regard.~      The purpose of this study is to determine the incidence and extent of macular edema following~     scatter laser photocoagulation surgery using optical coherence tomography (OCT) in eyes~     without macular edema prior to scatter laser photocoagulation and to explore whether the~     incidence and extent of macular edema varies according to the number of sittings included in~     the treatment regimen.~      Study eyes will receive one of two types of scatter photocoagulation with results compared~     through use of OCT and photography images, as well as visual acuity testing.~   "
219403|NCT00687141|"~     The primary purpose of this study is to investigate the safety and tolerability of AZD0328~     following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum~     tolerated dose.~   "
219404|NCT00687128|"~     This study investigates the degree of improvement in insulin resistance and features of the~     metabolic syndrome in non-diabetic overweight or obese subjects after training in a~     low-intensity, moderate-intensity or non-aerobic exercise program, as well as self-initiated~     exercise behavior after the assigned exercise program.~   "
219405|NCT00687115|"~     This study will investigate how to better predict why some individuals gain or lose weight~     more easily than others. It will examine whether the increase in the amount of energy a body~     burns in 24 hours with overeating or the decrease over 24 hours with fasting can help~     determine how easily someone gains or loses weight.~      Healthy people between 18 and 60 years of age who have a body mass index (BMI) between 18.5~     kg/m(2) and 24 kg/m(2) (for overfeeding study) or a BMI greater than 27 kg/m(2) with a body~     weight less than 350 pounds (weight loss study) may be eligible for this study. The study~     requires a 10-week admission to the NIH Clinical Center (2-week baseline, 6-week~     overfeeding/weight loss, 2-week post-weight change).~      Participants undergo the following tests and procedures during the hospital admission:~        -  Medical history, physical examination and laboratory studies~        -  Questionnaires to assess eating behavior, food preferences, body composition, and~          activity level~        -  Body composition assessment (height, weight, waist circumference, and fat mass and~          muscle content through DXA and MRI scans)~        -  Oral glucose tolerance test~        -  Meal test to measure the response of certain hormones to food~        -  Activity monitors to determine activity level~        -  Metabolic chamber study to measure calories burned over 24 hours and monitor body~          temperature~        -  Free-living energy use study to measure calories burned under normal home conditions~          over 7 days~        -  Fat and muscle biopsies~        -  Dietary intervention: Measurements of food intake and energy loss over a 6-week~          overfeeding (1.5 times the subject s normal food intake) or weight loss (one-half the~          subject s normal food intake) program~      Followup procedures after the inpatient stay:~        -  Height and weight measurements at 6 months (overfeeding study participants) and monthly~          for the first year, at 3-month intervals for the second year, and then yearly for 3 more~          years (weight loss study participants)~        -  Yearly visits (2-night inpatient stay) for all participants for repeat meal test, DXA,~          oral glucose tolerance test, behavioral questionnaires and, in women who can become~          pregnant, pregnancy test~   "
219406|NCT00687102|"~     The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive~     aging in selected cognitively-healthy women.~   "
219407|NCT00687089|"~     People who addicted to Heroin and other opiates suffer from a disease with approved genetic~     basis. It causes to a behavioral response as searching and using those drugs even though they~     know it causes severe damages as physiological, familiar and legal affairs.~      The popular treatment's goal is to clean the people from any drug. In a medical and~     pharmacological point of view there is no sense in this approach for all people. This point~     of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.~      The hypothesis of this research is that people using Buprenorphine have difficulties in~     gaining weight, in sexual and cognitive function (according to subjects' reports)~   "
219408|NCT00687076|"~     Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of~     a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which~     can result in reduced blood flow to the legs and feet, occasionally causing leg pain and~     fatigue. Early identification of PAD and treatment with lifestyle changes or medications can~     help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or~     surgical procedures may be necessary for people with severe PAD. Even after endovascular~     intervention, PAD symptoms must be continually monitored to prevent the development and~     progression of blockages in the arteries. The best approach for monitoring symptoms is still~     undetermined. This study will compare the effectiveness of an intensive combination of lipid~     modifying medications versus standard lipid modifying medications in treating people with~     significant PAD who have had an endovascular intervention.~   "
219409|NCT00687063|"~     The study is conducted in Asia. The aim of this observational study is to evaluate the weight~     change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under~     normal clinical practice conditions in India.~   "
219410|NCT00687050|"~     End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic~     changes or both. Human immunodeficiency virus-infection may exacerbate the state of~     malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on~     hemodialysis. Non-HIV patients will be randomized to peroral supplemental nutrition or no~     peroral supplemental nutrition. All HIV patients will receive peroral supplemental nutrition.~     The nutritional state will be determined in magnet resonance tomography at the start and at~     the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma~     albumin and others). The hypothesis is that supplemental peroral nutrition (a total 250 kcal~     per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their~     counterparts without supplemental peroral nutrition) as well as in the high risk group of HIV~     patients. This pilot study may lead to larger randomized clinical trials and, may affect~     dietary recommendations.~   "
219411|NCT00687037|"~     To prove the safety, in normal conditions, of the odontological use formulation of the~     product Cepacol Canela Power.~   "
219412|NCT00687024|"~     Focal cortical dysplasia (FCD) is a common finding in epilepsy surgery in pediatric patients.~     Children with intractable epilepsy would have extensive tests to identify the cause of~     epilepsy; this includes MR brain, video EEG and magnetoencephalography (MEG). The white~     matter next to FCD is frequently found to be abnormal on pathology. Diffusion tensor imaging~     (DTI) can be used to study the abnormal white matter and the area that often extends beyond~     the area that is visible.~   "
219413|NCT00687011|"~     The purpose of this study is to determine if a single intravenous (IV) dose of palonosetron~     0.25 mg plus a single IV dose of dexamethasone 8 mg is effective to prevent nausea and~     vomiting induced by moderately emetogenic chemotherapy in subjects with cancer.~   "
219414|NCT00686998|"~     This study is designed to assess the effects of AZD 2624 in patients with schizophrenia~   "
219415|NCT00686985|"~     Phase II studies with docetaxel in first line - and second line treatment of SCLC~     demonstrated that docetaxel is an active agent in these patient groups. Therefore docetaxel~     seems suitable for evaluation in combination with other cytotoxic drugs active in this~     disease. A phase II study in previously untreated patients with SCLC shows that the~     combination docetaxel and cisplatin/carboplatin is an active and well tolerated regimen in~     extensive SCLC.~   "
219416|NCT00686972|"~     This study is being conducted to evaluate changes in sugar, metabolism, heart function and~     changes in body composition as patients lose weight following bariatric surgery. The~     investigators will compare improvements of the above changes as a function of the four~     different types of bariatric surgery. The investigators believe the most beneficial and~     safest procedure will be the Roux-en-Y.~   "
219417|NCT00686959|"~     This study will compare the overall survival of participants with locally-advanced, Stage III~     Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.~   "
219418|NCT00686946|"~     The National Register of Antipsychotic Medication in Pregnancy (NRAMP)is an observational,~     nationwide study involving women of child-bearing age who take antipsychotic medication~     during pregnancy. It follows the pathway of mother and baby during pregnancy and for the~     first 12 months of the baby's life, in order to develop evidence-based guidelines for the~     best use and effect of antipsychotic medication during pregnancy, thereby informing clinical~     treating teams with regard to the management of their patients in this vulnerable population~     group.~      The investigators hypothesize that the provision of such evidence-based guidelines will~     improve the management and outcomes for mother and baby during pregnancy, birth and the~     postnatal phase, providing a positive impact on maternal and child health and wellbeing for~     present and future generations.~   "
219419|NCT00686933|"~     The objective of this study is to evaluate the long-term effects and tolerability of ABT-089~     in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
219420|NCT00686920|"~     This study will look at the safety of a drug used in patients who have had hepatic~     encephalopathy in the past.~   "
219421|NCT00686907|"~     The primary two foci of this five-year study will be to assess inter-individual variability~     in the timing of the body clock of blind individuals, and to optimize the melatonin dosing~     regimen for synchronizing body clocks of blind individuals to the 24-hour day.~   "
219422|NCT00686894|"~     Subjects will be given 3 infusions of infliximab according to the label at week 0, 2, and 6.~     Subjects will be followed for a maximum of 18 weeks or until relapse. This study will assess~     the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis~     response and relapse in subjects treated with infliximab.~   "
219423|NCT00686881|"~     The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b)~     monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in~     participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2~     and F3) who were previously treated with interferon. The trial will evaluate the effect of~     treatment on the progression of liver fibrosis, liver inflammation, and liver function.~     Treatment will be administered for up to 156 weeks with a 4-week follow-up.~   "
219424|NCT00686868|"~     This study will examine the safety and tolerability, PK and PD of subcutaneously administered~     GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose~     escalation/de-escalation phase to investigate the minimal efficacious dose based on PD~     markers with an acceptable safety profile.~   "
219425|NCT00686855|"~     The purpose of this research study is to determine the effectiveness of topical steroid~     therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment~     of oral chronic Graft-Versus-Host Disease (cGVHD)~   "
219426|NCT00686842|"~     RATIONALE: PTC299 may stop the growth of Kaposi sarcoma by blocking blood flow to the tumor.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of PTC299 and to~     see how well it works in treating patients with HIV-related Kaposi sarcoma.~   "
219427|NCT00686829|"~     The purpose of this study is to provide open-label vicriviroc to HIV treatment-experienced~     subjects who successfully completed 48 weeks of treatment on ACTG protocol A5211 (or who~     responded favorably to treatment but discontinued participation due to viral tropism shifts),~     and subjects who screened for ACTG A5211 and met all inclusion and exclusion criteria, but~     were unable to enroll due to protocol closure. Vicriviroc will be administered in combination~     with an optimized background antiviral regimen, chosen by the investigator based on results~     of genotype and phenotype testing, the subject's history of prior antiretroviral drug use,~     and drug toxicity. OBT must include at least 3 antiviral drugs (not including vicriviroc), 1~     of which is a ritonavir-boosted protease inhibitor.~   "
219428|NCT00686816|"~     This is a six (6) month, single center, randomized, double-blind, parallel,~     controlled-feeding weight-loss study comparing two dietary groups (triglyceride and olestra)~     in pre-diabetic obese women.~   "
219429|NCT00686803|"~     The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension.~     Including in this evaluation is the effect PL3994 has on blood pressure.~   "
219430|NCT00686790|"~     The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5~     mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected~     with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic,~     biochemical, and histological response will be evaluated.~   "
219431|NCT00686777|"~     The objective is to evaluate the efficacy and safety of the combination therapy with~     subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose~     ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who~     are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.~   "
219432|NCT00686764|"~     Background: The formation of neuromas, a fusiform swelling of a nerve or nerve ending, is a~     well documented response to limb amputation. Likewise, Residual Limb Pain (RLP), pain felt~     from the remaining portion of the amputated limb, is common among amputees. Neuromas are~     found in more than 90% of lower extremity amputations, of which 30-50% are pain-generating~     for the patient . And while surgical techniques reveal the commonly held belief that neuroma~     formation is one of the causal drivers behind RLP, there has been no study to demonstrate~     that the two events - namely the magnitude of neuroma formation and the magnitude of pain~     experienced by amputees - are correlated. If this correlation, or lack thereof, were~     elucidated with the use of ultrasonography, this would provide the preliminary data which~     could lead to further studies in neuroma minimization and/or proliferation.~      Objective: This study seeks to use ultrasonography (US) to quantify the degree to which~     neuroma size and the nature of surrounding tissue correlate with the experience of RLP in~     trans-femoral amputees.~      Setting and Subjects: This study will enroll 30 trans-femoral amputees, male and female, who~     are over the age of 18. The study will take place in the OHSU Orthopaedic Outpatient Clinic,~     and OHSU Imaging Department.~      Intervention: None. This is an observational clinical study in which we will characterize the~     sciatic nerve/neuroma and surrounding tissue using ultrasound.~      Measurements: We will use US to measure the cross sectional area of the neuroma at its widest~     point and compare this to the cross section of the same neuron at the lesser trochanter.~     Furthermore, we will describe the morphology of the neuroma. To quantify the subject's pain~     experience we will utilize the Questionnaire for Persons with Transfemoral Amputation~     (Q-TFA), Trinity Amputation & Prosthetic Experience Scale (TAPES), Visual Analog Scale (VAS),~     and the Short Form 36 (SF-36).~      Analysis: The statistical analysis will employ a Pearson correlation coefficient and linear~     regression analysis.~   "
219449|NCT00686543|"~     The purpose of this study is: to explore the potential for different dosing strategies of~     posaconazole oral suspension (POS) to increase plasma levels and to profile the~     pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal~     function and at high risk for Invasive Fungal Infection.~   "
219433|NCT00686751|"~     The purpose of this study to examine whether vitamin D can reduce the activation of the~     immune system during dialysis. When activated, the immune cells release certain substances,~     called cytokines, which can be measured from small blood samples. We want to study to what~     degree the immune system is activated during a regular dialysis treatment and whether the~     time point of vitamin D administration, either right before the start or right at the end of~     a dialysis treatment, has an impact on the activation of the immune system.~   "
219434|NCT00686738|"~     The purpose of this study is to develop indices predicting response to pre-operative~     chemotherapy in osteosarcoma patients. Histologic response to pre-operative chemotherapy is~     very important for the ultimate outcome of osteosarcoma patients. Conventional methods such~     as CT or MRI evaluating tumor response to chemotherapy is not so efficient in tumors like~     osteosarcoma. Instead, the investigators will test whether blood TGF-b1 levels, PET/CT~     findings, MRS findings as well as the level of NF-kB expression in tumor tissues can predict~     chemotherapy response in osteosarcoma.~   "
219435|NCT00686725|"~     The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery~     temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the~     standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma~     multiforme.~   "
219436|NCT00686712|"~     To compare the efficacy and safety of once-nightly insulin glargine versus a single morning~     injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients~     inadequately controlled on combination oral agents.~   "
219437|NCT00686699|"~     This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce~     drug-induced involuntary movements in participants with schizophrenia or schizoaffective~     disorder. Participants were to be evaluated for two 14-day treatment periods with a 3-week~     washout period between treatment periods. The primary outcome measure, Extrapyramidal Symptom~     Rating Score (ESRS), was to be evaluated frequently during the treatment periods.~   "
219438|NCT00686686|"~     Subjects with psoriasis will receive intravenous infliximab 5 mg/kg given over a 2-hour~     period at Weeks 0, 2, and 6 (induction therapy) to evaluate the efficacy of infliximab at~     Week 18. Subjects who achieved >=75% improvement in Psoriasis Pustulosa Palmoplantaris Area~     and Severity Index (PPPASI) score at Week 8 AND had deterioration of PPPASI score of 50% from~     Week 8 until Week 12 were to receive an additional infusion at Week 12.~   "
219439|NCT00686673|"~     This study is a randomized controlled trial that will compare two arms: an experimental~     intervention group that receives a decision aid consisting of an educational video and~     targeted manual providing a protocol for the family members' disclosing terminal illness to~     the patients and aimed at improving communication, satisfaction with decision making process,~     and quality of life between patients and their family versus an attention control group that~     receives a video and non-tailored manual on pain control.~   "
219440|NCT00686660|"~     This is a multi-center prospective follow-up study.~        -  to choose the stable COPD patients in community~        -  to compare different modes of exercise (cycling and walking)~        -  to compare the effect of different exercises on the quality of life,exercise~          endurance,dyspnea and depression~   "
219441|NCT00686647|"~     The purpose of this study is to evaluate a new angioplasty catheter, AngioSculpt® for the~     treatment of bifurcation lesions (blockages occurring at branch points) in coronary arteries.~   "
219442|NCT00686634|"~     This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in~     comparison to thiazolidinediones as the third-line oral agent, in patients with type 2~     diabetes mellitus.~   "
219443|NCT00686621|"~     The purpose of this study is to provide posaconazole compassionate treatment to patients with~     invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for~     which there are no effective therapies; 3) with a prior history of serious, severe, or~     life-threatening toxicities while receiving standard antifungal therapies, or 4) with~     pre-existing organ dysfunction which precludes the use of standard antifungal therapies.~   "
219444|NCT00686608|"~     The purpose of this study is to identify how certain parts of the brain that control appetite~     respond to changes in dietary carbohydrate and fat.~   "
219445|NCT00686595|"~     This study will evaluate the efficacy, tolerability, and effect on the quality of life of~     infliximab in adults with moderate-to-severe psoriasis who are resistant to etanercept after~     12 weeks of treatment or have failed 24 weeks of treatment with etanercept. Infliximab will~     be administered as an intravenous infusion of 5 mg/kg at Baseline (Week 0), Visit 3 (Week 2),~     Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).~   "
219446|NCT00686582|"~     The objective of the current study is to show that the immune response of subjects previously~     vaccinated with one or two doses of IMVAMUNE® can be boosted two years later with one~     IMVAMUNE® vaccination. Assessment of individual antibody titers within short time intervals~     following the booster vaccination will provide information on how fast and effective~     measurable antibody titers can be reactivated.~      In summary, this study is intended to confirm that a single dose of IMVAMUNE® can reactivate~     antibody titers in subjects after being primed with one or two doses of IMVAMUNE®.~   "
219447|NCT00686569|"~     Postoperative anastomotic leakage is a serious complication in patients with oesophageal or~     cardia cancer. Early diagnosis and treatment are mandatory. The primary aim of the present~     study is to investigate the clinical use of mediastinal microdialysis and whether is able to~     detect anastomotic leakage prior to the development of clinical symptoms.~   "
219448|NCT00686556|"~     RATIONALE: Giving chemotherapy and total marrow irradiation before a donor umbilical cord~     blood or hematopoietic stem cell transplant helps stop the growth of cancer cells. It may~     also stop the patient's immune system from rejecting the donor's stem cells. When the healthy~     stem cells from a donor are infused into the patient they may help the patient's bone marrow~     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from~     happening.~      PURPOSE: This phase I trial is studying the side effects and best dose of total marrow~     irradiation when given together with combination chemotherapy and umbilical cord blood~     hematopoietic stem cell transplant in treating patients with acute leukemia, acute myeloid~     leukemia or multiple myeloma that did not respond to previous therapy.~   "
219450|NCT00686530|"~     Examination of the fetal brain at autopsy is technically challenging because of marked~     fragility of the brain tissue. Studies have found postmortem fetal MR to be particularly~     useful in examining gross structural abnormalities in fetal brain and spine. We have recently~     included postmortem MR as part of the radiological studies for fetal autopsy workup. Using~     the same MR data, the development of normal layering of the brain, also called laminar~     organization, can also be assessed. This laminar organization of the brain is often disturbed~     in congenital malformations. Our aim is to study the disturbance in laminar organization of~     the postmortem brain with MR, using structural MR and a type of MR sequence called diffusion~     tensor imaging, which is well suited for assessing the organization of the developing brain.~     The postmortem MR findings will be compared with gold standard of histopathology. This will~     help us understand the abnormal development of gray and white matter in brain malformations.~     Knowledge gained from studying the abnormal laminar organization in brain malformations will~     serve as a reference for future studies of fetal brain malformations in-utero using MRI.~   "
219451|NCT00686517|"~     The objective of this study is to evaluate the efficacy of three regimens of pegylated~     interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in~     participants with acute hepatitis C. After 12 weeks of observation from disease onset,~     participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN~     monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3)~     a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the~     treatment period, participants will enter a 12-month follow-up.~   "
219452|NCT00686504|"~     The study is carried out in order to determine the relationship between AZD2066 exposure and~     mGluR5 receptor occupancy in the brain and to demonstrate that AZD2066 can displace~     [11C]AZ12713580 from mGluR5 binding-sites in the Central Nervous System~   "
219453|NCT00686491|"~     Eleven National Sports Teams are located in the Quebec Metropolitan Area. In these groups,~     many athletes are aiming for Olympic medals in Beijing 2008 and Vancouver 2010 Olympic Games.~     A consultation of the coaches of these National Teams revealed that although a large~     proportion of these athletes present various cardio-respiratory symptoms, they do not have a~     rapid access to a systematic medical evaluation and follow-up. Furthermore, little is done in~     regard to prevention and optimization of treatment of pulmonary and cardiac conditions in the~     elite athlete's population of the Quebec area.~      Cardiorespiratory problems are therefore commonly found in high-level athletes. However,~     these pathologies are not well characterized in athletes and the associated symptoms often~     not well perceived. These problems can be serious and it is important to detect them before~     they appear1 while setting up a systematic medical follow-up. Health professionals should~     monitor health of the young athletes and help to reduce the risks associated with high level~     exercise. The following project is an evaluation and follow-up program of high-level~     athletes, aiming at gathering key-information on long-term effects of high-level training on~     cardio-respiratory and metabolic parameters. Our aims will be~        1. to establish a long-term program of systematic evaluation and follow-up of~          cardiorespiratory health and performance of high elite athletes.~        2. to evaluate the prevalence of respiratory, circulatory and metabolic problems among~          high-level athletes~        3. to evaluate the effects of treatments on cardiorespiratory conditions and exercise~          performance in athletes who need asthma medication.~   "
219454|NCT00686478|"~     This study assesses the intervention with antifibrotic agents, specifically interferon (IFN)~     to reduce the magnitude and duration of hypertrophic scar. Burn patients with hypertrophic~     scar are randomly assigned to either an intervention IFN group or a placebo control group by~     subcutaneous injection three times a week. Patients are assessed using cutometer, mexameter,~     standardized photography, urinalysis, blood work, tissue biopsies and the Vancouver Burn Scar~     Assessment (VBSA) which rates selected HTS based on color, vascularity, height, pliability,~     itchiness and pain sensitivity. Once on treatment patients are assessed monthly for the six~     month treatment period.~   "
219455|NCT00686465|"~     Sometimes, cancer comes back after it has been successfully treated—a situation called~     recurrent cancer. When recurrent cancer is suspected, the standard approach to diagnosis is~     to perform a combination of imaging tests, such as x-rays, ultrasound, computed tomography~     (CT), magnetic resonance imaging (MRI), and nuclear medicine scans. Sometimes, however, after~     performing these tests it still may not be clear whether or not the cancer has come back.~      Some studies have shown that a diagnostic imaging test called Positron Emission~     Tomography/Computed Tomography (PET/CT) may be helpful in the diagnosis of recurrent lung,~     breast, head and neck, ovarian or esophageal cancer or lymphoma. However, it is not clear if~     PET/CT can offer better results than standard approaches to diagnosis.~      This feasibility study is needed to determine how common it is for a diagnosis of recurrent~     cancer to be unclear even after standard diagnostic imaging tests have been completed. If the~     enrollment goal is reached (~60 patients enrolled in 18 months), a larger clinical trial is~     being planned to determine if PET/CT is helpful in making the diagnosis of recurrent cancer~     in situations where standard imaging tests have not been helpful. It is also expected that~     the results of this feasibility study will help to define exactly which patients should be~     enrolled in this larger clinical trial of PET/CT.~   "
219456|NCT00686452|"~     Swimmers show the highest prevalence of asthma among elite athletes, certainly due to~     chlorine exposure. The consequences of a chronic exposure to chlorine compounds by swimmers~     and the mechanisms of asthme in this population are still poorly documented. Specific~     diagnostic criteria have been proposed by the International Olympic Committee - Medical~     Council (IOC-MC) and World anti-doping agency (WADA) to determine the presence of asthma in~     athletes. Using the more specific bronchial provocation tests, our aims are~        1. to compare the prevalence of asthma in swimmers and control subjects~        2. to analyze the Influence of chlorine exposure on bronchial inflammatory processes in~          swimmers versus control subjects~        3. to study the time-course of changes in airway symptoms, responsiveness, inflammation and~          remodeling after cessation of training~   "
219457|NCT00686439|"~     We will conduct a pilot study of the effectiveness of adalimumab for inflammatory~     osteoarthritis.~   "
219470|NCT00686270|"~     This study will examine the long term safety of apricitabine in HIV-1 infected patients from~     studies AVX-301 or AVX-302. Eligible patients are those who have either (a)completed studies~     AVX-301 or AVX-302; or (b)met the criteria for virological failure/lack of response, and~     consequently wish to withdraw early from studies AVX-301 or AVX-302.~   "
219458|NCT00686426|"~     The goal of the current study is to determine the role of dairy in similarly preventing~     weight and fat re-gain in obese adults who have successfully completed a weight loss diet~     program.240 obese subjects will undergo a meal-replacement-based weight loss plan designed to~     produce a 10 kg weight loss in 8-12 weeks. Upon achieving the weight loss goal, subjects will~     be randomly assigned to either a low-dairy or high-dairy eucaloric weight maintenance diet~     for two years. Macronutrient distribution will be maintained constant and set at~     approximately the U.S. average. Primary outcomes include changes in body weight, body fat and~     anatomical distribution of fat (via dual x-ray absorptiometry) and resting metabolic rate and~     substrate oxidation (via respiratory calorimetry); Secondary outcomes include blood pressure,~     circulating glucose, insulin, lipids and calcitrophic hormones. on prevention of weight~     regain in humans has not yet been assessed in clinical trials.~   "
219459|NCT00686413|"~     The study is being performed in order to learn more about AZD3480 (potential as treatment for~     patients with Alzheimer's Disease) and to investigate how much of AZD3480 is bound to the~     nicotinic receptors in the brain at different concentrations of AZD3480 in blood, as well as~     to investigate the period of time for this binding.~   "
219460|NCT00686400|"~     Environmental risk factors for the development of schizophrenia include infections during the~     perinatal period or later in life with Toxoplasma gondii (TG) being one of the candidate~     agents. A recent review (Torrey and Yolken, 2003) on TG in schizophrenia and other serious~     mental disorder reported higher antibodies to TG in patients compared to controls in 18 of 19~     studies, one having been conducted by the investigators group. In a second, independent study~     on first-episode schizophrenia (n=56) and control subjects (n=32), sera were sampled and~     standard instruments used to assess diagnoses and psychopathology, respectively to screening~     controls.~      For the total sample, contacts with animals during pregnancy and age emerged as a~     non-significant predictors of TG IgG titers. Means of patients' and controls' TG IgG titers~     did not differ significantly but variances did; a subgroup of patients' titers reached much~     higher levels than those of controls. Patients in the high TG IgG subgroup were older~     (p=0.001), also they were older when psychiatric symptoms appeared, more individuals had~     regular animal contacts during pregnancy, or rural upbringing including regular animal~     contact, more consumption of raw meat, and a higher absolute treatment response (all trend~     levels). Regarding the short term course of patients, the investigators detected decreasing~     IgG titers in several individuals A power analysis demonstrated that results fell short of~     significance due to lack of statistical power. Based on the power analysis, the investigators~     propose an opel label, multicenter study at three regionally different sites within Germany~     (Halle, Hamm, Heidelberg). The investigators intent to study 173 first-episode patients with~     schizophrenia, schizoaffective, and schizophreniform disorder and 173 matched controls.~      The investigators hypothesize that - according to the heterogeneity of the illness - a~     subgroup of patients will exhibit higher TG IgG titers compared to the remaining patients and~     to controls; that this subgroup will have had regular contact with animals during pregnancy~     and early life as well as developmental delays; and that clinical improvement, response to~     treatment, and subjective well-being will run parallel with TG IgG decrease.~      Patients shall be assessed on admission to hospital, at discharge and at 6- and~     12-month-follow-up with respect to TG antibody titers, symptomatology, neuropsychology,~     predictors of outcome, quality of life, and neurological soft signs. In controls two~     assessments shall be performed, 12 months apart. All foreseen assessments will be performed~     using standard measurement instruments with sound reliability and validity such as the SCID~     and the PANSS. Exposure to cats, other warm-blooded life-stock, and raw meat will be assessed~     using a special questionnaire.~   "
219461|NCT00686387|"~     The purpose of this study is to establish a Brain and Spinal Tumor Tissue/Specimen repository~     to serve as a resource for current and future scientific studies.~   "
219462|NCT00686374|"~     This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody~     adalimumab as an effective therapy for maintaining clinical response in pediatric~     participants with Crohn's disease (CD) and to gather long-term safety and tolerability data~     in this population. Participants were allowed to enroll in the study if they participated in~     and successfully completed Study M06-806 (NCT00409682) through Week 52.~   "
219463|NCT00686361|"~     Cystic Fibrosis (CF) is a complex disease with a wide range of clinical problems. Despite~     enzyme replacement therapy, children with cystic fibrosis (CF) may still have problems~     absorbing some nutrients. Detailed studies of the nutrient status of children with CF and~     have found low amounts of choline, an essential dietary nutrient, and altered levels of some~     amino acids in almost all patients. Choline is an essential dietary nutrient that is~     important in many important body functions, which include proving a source of methyl groups,~     the structure of cell membranes and in acetylcholine. Most choline is present in our diets in~     a fat known as phosphatidylcholine. Research studies have shown that children with cystic~     fibrosis do not absorb fat, including phosphatidylcholine very well. In previous studies, we~     showed that choline provided as a dietary supplement for 2 weeks improved choline status in~     children with cystic fibrosis.~      The purpose of this research is to find out if choline supplements over a longer duration of~     6 months will improve and maintain normal choline status in children with CF.~   "
219464|NCT00686348|"~     To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when~     administered by a health care professional (HCP), the patient, the patient's partner or~     parent/guardian as part of their routine acromegaly care.~   "
219465|NCT00686335|"~     The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the~     efficacy and safety of modified release Prednisone on signs and symptoms.~   "
219466|NCT00686322|"~     Present study is to investigate efficacy and toxicity profiles of induction one cycle of~     paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2~     cycles of PC consolidation chemotherapy.~   "
219467|NCT00686309|"~     Asthma is a major health problem worldwide. The measurement of fractional exhaled nitric~     oxide (FENO) has been established as a valuable non invasive and simple tool in the diagnosis~     of asthma and may also act as a useful surrogate inflammatory marker on which to base~     treatment decisions in asthma management algorithms. The measurement is useful also in other~     respiratory diseases. Current methods of measuring FENO include on line measurements by heavy~     duty expensive analyzers which are not widely and easily available. Off line measurements of~     breath samples which can be analysed later may be a simple solution. We hypothesize tha toff~     line measurements of NO will be as reliable and valid as those measured on-line~   "
219468|NCT00686296|"~     To evaluate wound healing with the use of Taliderm™ dressing and compare it to wet to dry~     dressing in the treatment of open wounds after incision and drainage.~   "
219469|NCT00686283|"~     This study aims to determine the likely benefits of a study that would use the novel~     techniques both of writing an exercise prescription and of including the family and/or~     community in sticking to the exercise prescription by youths with diabetes, who often suffer~     eventual cardiovascular complications that might be lessened by the exercise.~   "
219487|NCT00686036|"~     The purpose of this study is to determine whether treatment with Zactima for up to 18 months~     will prolong the off-treatment interval in patients who are undergoing intermittent androgen~     deprivation therapy.~   "
219471|NCT00686257|"~     The purpose of this study is to compare the Total Face Mask™ (Respironics, Inc., Pittsburgh,~     PA) (covering whole face) and the standard oronasal facemask (covering nose and mouth) for~     the emergency treatment of patients with acute respiratory failure with the machine blowing~     air into the mask placed on the face (noninvasive positive pressure ventilation) (NPPV).~   "
219472|NCT00686244|"~     Prospective, randomized, single center, controlled intervention study to investigate the~     effect of a systematic combined personal and IT-based training on the outcome of patients~     with metabolic syndrome.~   "
219473|NCT00686231|"~     The radial artery, which is located on the outer side of the forearm, can be used in~     interventional procedures, such as cardiac catheterization, to provide access to the arterial~     blood supply. In order to facilitate successful catheterization of the artery, a dilated~     artery and one free of arterial spasm is desirable. The proposed study will randomize twenty~     three healthy subjects to determine the effect of topical nitroglycerin on radial artery~     vasodilation. In the first phase of the study, which is a dose escalation study, each subject~     will receive either one or two inches of nitroglycerin in a blinded manner on one wrist and~     placebo on the other. Radial artery diameter will be measured with ultrasound at regular~     intervals up to two hours. The subjects will then return at a later date at which point they~     will receive the alternate dose on one wrist and placebo on the other. In the second phase of~     the study, we will randomize the same patients to a mixture of topical nitroglycerin and~     lidocaine or topical lidocaine alone. Measurements of radial artery diameter will be~     performed as in the first study.~   "
219474|NCT00686218|"~     RATIONALE: Panobinostat and imatinib mesylate may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when~     given together with imatinib in treating patients with previously treated chronic phase~     chronic myelogenous leukemia.~   "
219475|NCT00686205|"~     To test blood samples from volunteer donors of whole blood and blood components using a new~     investigational test that detects human immunodeficiency virus (HIV) infection. Results will~     be compared to the current HIV screening assay.~   "
219476|NCT00686192|"~     We hope to determine if supplementing the diet of women who habitually consume low levels of~     calcium, with 1500 mg of calcium a day for three months will increase fat oxidation and~     decrease fat storage. We will also measure concentrations of lipids, glucose, hormones and~     enzymes associated with fat and carbohydrate metabolism to determine alterations and~     mechanism of the metabolic changes.~   "
219477|NCT00686179|"~     The purpose of this study is to evaluate the effects on cardiac repolarisation of~     supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped~     as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using~     moxifloxacin as positive control.~   "
219478|NCT00686166|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This phase II trial is studying the side effects and how well giving oxaliplatin,~     capecitabine, and cetuximab together with radiation therapy followed by surgery works in~     treating patients with stage II or stage III rectal cancer.~   "
219479|NCT00686140|"~     A double-blind, randomized, placebo-controlled trial of celecoxib as an add-on therapy to~     risperidone compared to risperidone plus placebo in the treatment of 200 treatment-naive~     first-episode patients with schizophrenia. The study addresses an immune dysfunction~     hypothesis of schizophrenia.~   "
219480|NCT00686127|"~     This trial is part of a larger, longitudinal study of symptoms that occur in the breast~     surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop~     pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a~     lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women~     who wear the lidocaine patch will report a decrease in pain and decreased interference with~     function compared to women who wear the placebo patch.~   "
219481|NCT00686114|"~     This study is multi-center randomized phase III one to evaluate the difference in~     local-control and survival rate between patients receiving concurrent chemoradiotherapy~     combined Tarceva or not.~   "
219482|NCT00686101|"~     This proposed 2-year questionnaire study examines views and attitudes regarding health risks~     of cigarette smoking, smoking patterns and motivators for cessation in smokers who suffer~     from schizophrenia compared to a sample of smokers without a major psychotic disorder.~   "
219483|NCT00686088|"~     The purpose of this study is to determine the therapeutic activity of different~     concentrations of PRX302 at increasing volumes and/or number of deposits per gram of~     prostate. Therapeutic activity will be determined based on changes in PSA levels, PSA~     velocity, PSA doubling time and tumor burden following treatment.~   "
219484|NCT00686075|"~     Primary objective of this study is to describe the safety and tolerability of multiple doses~     of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age.~   "
219485|NCT00686062|"~     This is a randomized study of an interactive, computerized descision-assisting tool for~     prenatal testing decision making (PT Tool) versus standard educational booklets distributed~     to all pregnant women by the State of California (control). We hypothesize that, compared to~     controls, women randomized to view PT Tool will have greater knowledge about prenatal testing~     and its potential outcomes and better risk comprehension, and that they will be more~     satisfied with the intervention and have lower decisional conflict.~   "
219486|NCT00686049|"~     The goal of this study is to assess the reliability of the HIV~      Treatment Readiness Measure (HTRM) to assist clinicians in:~      (1) determining whether or not youth living with HIV are ready to initiate HAART and (2)~     identifying youth who may be in need of additional support services to facilitate their~     adherence to HAART. The current study will examine the psychometric properties of the HTRM~     and establish its test-retest reliability over a two week period. If the HTRM is found to be~     reliable, a subsequent study will examine its predictive validity.~   "
219490|NCT00685997|"~     Background:~      The malignant lymphomas, Hodgkin´s disease (HD) and non-Hodgkin´s lymphoma (NHL), comprise~     approximately 5-6% of all malignancies in adults and account for 10% of childhood cancers.~     Once the diagnosis has been established histologically, extent of disease (staging) and~     response to therapy will be assessed by means of a computed tomography (CT) scan of the body.~     The staging at presentation is important for determining prognosis and choice of treatment.~     Unfortunately, CT is accompanied by a significant amount of radiation exposure which may~     induce second cancers. This is especially important in childhood, because rapidly dividing~     cells are more sensitive to radiation induced effects and children will have more years ahead~     in which cancerous changes might occur. New magnetic resonance imaging (MRI) techniques offer~     an alternative way for staging and follow-up of cancers, including the malignant lymphomas.~     Whole-body MRI (WB-MRI) is a radiation-free method which allows imaging of the body with~     excellent soft tissue contrast in a single examination.~      Purpose:~      The aim of this study is to examine if WB-MRI can replace CT in staging of patients with a~     malignant lymphoma.~      Design:~      This will be a multicenter, prospective, diagnostic cohort study (timeschedule: 36 months).~     135 eligible patients will undergo WB-MRI on top of the protocolar imaging routinely done.~      Study population:~      Patients aged 8 years and older with a histological diagnosis of HD or NHL.~      Statistical analysis:~      The challenge of this study will be to show non-inferiority of WB-MRI compared to CT in~     staging malignant lymphoma. Testing of this hypothesis will be one-sided and performed using~     recently proposed techniques by Lui et al.~      Radiation-related risk assessment:~      A risk model will be used, based on the BEIR VII report, for modelling the late-term~     mortality from radiation induced tumors after exposure to ionizing radiation.~      Economic evaluation:~      Actual costs (from a societal perspective) will be determined for the two diagnostic tests.~     In case of clinical equivalence and similar costs or cost savings associated with MRI the~     latter can be considered dominant, obviating further economic evaluation. Otherwise, through~     modelling of expected long term health impact and associated outcomes such as quality of life~     and costs the incremental cost effectiveness will be evaluated.~   "
219491|NCT00685984|"~     Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary~     stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral~     endothelial dysfunction is a marker of silent myocardial ischemia. The aim of the study is,~     in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary~     status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of~     abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia~     endothelium-dependent brachial artery dilation.~   "
219492|NCT00685971|"~     The main aim of the research question to test the primary hypothesis of this study, namely,~     Does 12 weeks of an additional 5000 IU daily of cholecalciferol increase serum 25OHD levels~     in adults with Cystic Fibrosis (CF) who have vitamin D deficiency relative to placebo?~   "
219493|NCT00685958|"~     The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous~     blood clots in patients with hip fracture surgery.~   "
219494|NCT00685945|"~     The purpose of the study is to determine if giving isosorbide,a drug that is used to treat~     chest pain, affects blood vessel release of an anti-clotting factor.~   "
219495|NCT00685932|"~     The purpose of this study is to investigate whether the use of the Mobius® retractor~     decreased post-operative pain after cesarean section verses conventional retractor use. Based~     on clinical experience and a pilot study, we suspect that the retractor will decrease overall~     pain as well as lateral pain.~   "
219496|NCT00685919|"~     The purpose of the proposed research is to determine how changes in kidney dopamine (DA)~     activity influence urinary sodium excretion. We will decrease DA activity in the kidney by~     inhibiting DA synthesis via carbidopa administration. We want to compare findings in normal~     volunteers and in patients with postural tachycardia syndrome (POTS). We will test the null~     hypothesis (Ho) that the effects of oral carbidopa administration on urinary sodium excretion~     will not differ between patients with POTS and healthy volunteers.~   "
219497|NCT00685906|"~     The purpose of this study is to examine the effect of co-administration of AZD6140 and~     Nordette® on the blood levels of certain female hormones.~   "
219498|NCT00685893|"~     The purpose of this research study is to evaluate an intervention to improve the care given~     to patients who are dying in the intensive care unit (ICU) and their families. This study is~     a multi-center randomized trial of a multi-faceted quality improvement intervention designed~     to improve the quality of palliative and end-of-life care in the ICU setting. The~     intervention targets the hospital and the outcome evaluation occurs at the level of the~     individual patient and family with surveys completed by family members and nurses as well as~     standardized medical record review.~   "
219499|NCT00685880|"~     Arthritis of the base of the thumb is a common debilitating problem. It is believed that~     laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be~     treated by securing the joint surgically or symptoms can be treated with hand therapy and/or~     injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease~     looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that~     prolotherapy injections for thumb arthritis will be equally or more beneficial to the~     patients than steroids.~   "
219500|NCT00685867|"~     The study is a two-arm controlled multi-centre trial of two strategies to reduce nosocomial~     MRSA transmission and infection among surgical patients. Enrolment and primary analyses will~     be performed at the hospital level. A total of ten adult surgical departments with at least 3~     surgical subspecialties each will participate in the study. Sites of the study are located in~     9 countries (UK, France, Spain, Germany, Switzerland, Italy, Serbia, Greece and Israel).~      The primary objective is to determine the effect of an early MRSA detection & decolonization~     & isolation strategy compared to an enhanced standard control strategy on~     healthcare-associated MRSA isolation rates among surgical patients at risk of MRSA carriage,~     who are hospitalized for at least 24 hours.~   "
219517|NCT00685646|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen blockade therapy~     may lessen the amount of androgens made by the body. Zoledronic acid may help relieve some of~     the symptoms caused by bone metastasis. It is not yet known whether androgen-blockade therapy~     is more effective with or without zoledronic acid in treating patients with prostate cancer~     that has spread to the bone.~      PURPOSE: This randomized phase III trial is studying androgen-blockade therapy given together~     with zoledronic acid to see how well it works compared with androgen-blockade therapy alone~     in treating patients with prostate cancer and bone metastases.~   "
219600|NCT00684567|"~     The purpose of this study is to evaluate the safety of combination therapy of radiotherapy~     and temozolomide (concomitant radiotherapy phase), and then temozolomide monotherapy~     (monotherapy phase), in patients with newly diagnosed glioblastoma multiforme. Progression~     free survival and response rate will also be calculated.~   "
219601|NCT00684554|"~     The study will assess the effectiveness of at-home vs. in-office induction for patients~     entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care~     clinic.~   "
219501|NCT00685854|"~     This study will examine whether the drug ranibizumab (Lucentis) can help prevent vision loss~     in people with macular telangiectasia, a condition in which new blood vessels grow in the~     retina at the back of the eye and can leak. Such changes in blood vessels are seen in other~     diseases associated with changes in a body chemical called vascular endothelial growth factor~     (VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease,~     age-related macular degeneration, with similar changes in eye blood vessels.~      People 18 years of age and older with macular telangiectasia in both eyes with no new blood~     vessel growth in either eye may be eligible for this study. They must have vision better than~     20/400 in the study eye.~      Participants undergo the following procedures:~        -  Ranibizumab injections in the study eye at least four times over 12 weeks. Depending on~          the response to treatment and the side effects, additional injections may be given every~          4 weeks for up to 1 year. The eye is numbed before the injection and the eye area is~          cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection~          to prevent infection.~        -  Evaluations before starting treatment, at the time of each injection, and 8 weeks after~          the last treatment:~             -  History and physical examination.~             -  Eye examination with dilation, microperimetry and photography: The eye examination~               measures visual acuity, eye pressure and eye movements. For the microperimetry~               test, subjects sit in front of a computer screen and press a button when they see a~               light on the screen. Measurements and photographs of the retina are also taken.~             -  Fluorescein and indocyanine green angiography to examine the blood vessels in the~               eye: A dye called fluorescein or indocyanine green is injected into a vein in the~               arm. The dye travels through the veins to the blood vessels in the eyes. A camera~               takes pictures of the dye as it flows through the blood vessels.~             -  Pregnancy test: Women who are able to become pregnant have a urine pregnancy test~               before each ranibizumab injection.~   "
219502|NCT00685841|"~     A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily~     compared to placebo in subjects with COPD.~   "
219503|NCT00685828|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. It is not yet known which dose of imatinib mesylate is more~     effective in treating gastrointestinal stromal tumor.~      PURPOSE: This randomized phase III trial is studying two different doses of imatinib mesylate~     to compare how well they work in treating patients with unresectable or metastatic~     gastrointestinal stromal tumor.~   "
219504|NCT00685815|"~     To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS)~     symptoms and brain concentrations of iron.~   "
219505|NCT00685802|"~     The purpose of this study is to evaluate and compare the relative bioavailability of a test~     formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after~     a single oral dose administered under fasting conditions.~   "
219506|NCT00685789|"~     The purpose of this study is to observe the influence of Deqi and neuropsychological factors~     on effects of acupuncture treatment for Bell's Palsy.~   "
219507|NCT00685776|"~     This study will evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to~     placebo, on plasma concentrations of Low Density Lipoprotein Cholesterol and assess the~     safety and tolerability of anacetrapib (100 mg) in participants with CHD/CHD risk-equivalent~     disease on stable dose regimen of statin with or without other lipid-modifying therapy. The~     two year extension to this study will further evaluate the long-term safety profile and~     efficacy of anacetrapib in CHD/CHD-risk equivalent patients who are on ongoing therapy with a~     statin with or without other lipid-modifying therapy.~   "
219508|NCT00685763|"~     The purpose of this study is to find out what effects, good and/or bad, proton radiation and~     chemotherapy has on you and your pancreatic cancer.~   "
219509|NCT00685750|"~     This study intends to analyze the expression of specific sets of markers in tumor samples and~     in serum from patients with Non-Small Cell lung Cancer (NSCLC) or Stage III or IV melanoma.~     The data obtained in this study will be used to guide future development of immunotherapies~     for melanoma or NSCLC patients. Moreover, the analyses will contribute to definition of~     markers potentially predictive of clinical response to specific anticancer therapies.~   "
219510|NCT00685737|"~     The Purpose of this study is to determine the safety and tolerability of 1-MNA, a drug that~     is intended to be used in the treatment of elevated levels of blood fats. This study will~     determine the way that 1-MNA is handled by the body, and will also determine its effect on~     commonly measured blood fat parameters.~   "
219511|NCT00685724|"~     Pathological gambling is serious problem, with significant psychological, financial, and~     public health consequences. Nevertheless, controlled trials examining the efficacy of~     therapeutic interventions for pathological gamblers are sparse, and many pathological~     gamblers recover on their own, or with only minimal interventions. In this initial study of a~     SMART design for pathological gamblers, we will offer a brief intervention to all (n = 100),~     and subsequently randomize individuals based upon their initial treatment response to varying~     intensities of additional care from none to 8 sessions of individual cognitive behavioral~     therapy (CBT) plus 14 weeks of Aftercare. Gambling outcomes will be assessed pre-treatment~     and at about weeks 10, 24, 36 and 52.~   "
219512|NCT00685711|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived~     peptide desensitising vaccine, currently being developed for the treatment of cat allergy.~     This study will investigate the safety of Cat-PAD administered as increasing single doses.~   "
219513|NCT00685698|"~     Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections~   "
219514|NCT00685685|"~     The purpose of this study is to evaluate and compare the relative bioavailability and~     therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent~     dose of Mevacor® tablets after a single oral dose administered under fasting conditions.~   "
219515|NCT00685672|"~     Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural~     solution given to women in childbirth~   "
219516|NCT00685659|"~     This study tests the effectiveness of two 24 month, telephone-based adaptive continuing care~     interventions for patients with cocaine dependence. The two interventions are predicted to~     produce better drug use outcomes than standard care. Furthermore, the intervention that also~     includes monetary incentives for continued participation is hypothesized to produce better~     retention and drug use outcomes than the intervention without incentives. Economic analyses~     will determine the cost-effectiveness and benefit-cost of the interventions relative to~     standard care, and to each other.~   "
219547|NCT00685256|"~     RATIONALE: A study that evaluates the support of a decision guide used together with genetic~     counseling may improve communication between mothers undergoing BRCA1/2 testing and their~     minor-age children.~      PURPOSE: This randomized phase III trial is studying standard genetic counseling given~     together with a decision guide to see how well it works compared with genetic counseling~     alone in improving communication between mothers undergoing BRCA1/2 testing and their~     minor-age children.~   "
219518|NCT00685633|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such~     as bicalutamide, may lessen the amount of androgens made by the body. Enzastaurin may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not~     yet known whether giving bicalutamide together with enzastaurin is more effective than~     bicalutamide alone in treating prostate cancer.~      PURPOSE: This randomized phase II trial is studying bicalutamide to see how well it works~     compared with giving bicalutamide together with enzastaurin in treating patients with~     prostate cancer.~   "
219519|NCT00685620|"~     Purpose of the project is to examine the effectiveness of Reinforcement-Based Treatment (RBT)~     on drug abuse and psychosocial outcomes of iner city opiate abusers who have recently~     completed a brief detoxification.~   "
219520|NCT00685607|"~     For six hours following drug administration, subjects will rate the severity of specific~     symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of~     the product.~   "
219521|NCT00685594|"~     The prevalence of type 2 diabetes is increasing, which for most societies has considerable~     consequences not only regarding health but also economy. Type 2 diabetes develops through a~     prediabetic stage with impaired glucose tolerance. Intervention at this stage with change~     in lifestyle or with medication may prevent such progression. There are indications that~     vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may~     increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with~     vitamin D may improve glucose tolerance and potentially prevent the development of type 2~     diabetes in subjects at risk. However, this has so far not been demonstrated in a~     prospective, randomised clinical study. In the present study we will therefore include 600~     subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso~     study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo~     for 5 years. A glucose tolerance test will be performed each year, and development of type 2~     diabetes will be the main endpoint.~   "
219522|NCT00685581|"~     The investigators' project has for principal objective to evaluate the impact of three~     specific ruminant milk fats with a Trans Fatty Acid content ranging from 2.9% to 12.2%~     obtained by modification of the cow's diet on cardiovascular risk factors in healthy~     subjects.~   "
219523|NCT00685568|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of celecoxib may keep polyps and colorectal cancer from forming in patients with familial~     adenomatous polyposis.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of~     celecoxib in treating young patients with a genetic predisposition for familial adenomatous~     polyposis.~   "
219524|NCT00685555|"~     The purpose of this research is to increase community awareness about the relationship~     between physical activity, screen time, and nutrition and how these factors influence healthy~     weight management.~      The problem of obesity is at epidemic proportions and has become the most important public~     health problem confronting the United States today. Of greatest concern is the 300% increase~     in obesity rates among children and youth over the past twenty years. Childhood obesity is a~     precursor of adult obesity.~   "
219525|NCT00685542|"~     Ostearthritis is one of the most common arthritis, affecting more than 30% of aged people~     world-widely. The disease is characterized by pain and stiffness of the affected joints and~     is the most common cause of disability in aged people. It commonly affects knee, hip, hand~     and spine joints. Diacerein is a drug developed specifically for the treatment of~     osteoarthritis. It has inhibitory effects on interleukin-1 (IL-1) and metalloproteases which~     are known to play key roles in the pathogenesis of osteoarthritis while exerting no effect on~     phospholipase A2, cyclooxygenase or lipoxygenase. It showed anti-inflammatory effects on~     animal models and reduced structural changes in several animal models. Therefore, we~     investigate the role of diacerein in patients with hand osteoarthritis.~   "
219526|NCT00685529|"~     The purpose of this study is to compare the blood levels of arformoterol tartrate inhalation~     solution to racemic formoterol in male and female subjects with mild to moderate Chronic~     Obstructive Pulmonary Disease (COPD).~   "
219527|NCT00685516|"~     RATIONALE: Green tea contains ingredients that may prevent or slow the growth of certain~     cancers. It is not yet known whether green tea is more effective than black tea or water in~     treating prostate cancer.~      PURPOSE: This randomized phase II trial is studying green tea to see how well it works~     compared with black tea and water in treating patients with prostate cancer undergoing~     surgery.~   "
219528|NCT00685503|"~     This study will examine whether the drug ranibizumab (Lucentis) can help prevent vision loss~     in people with macular telangiectasia, a condition in which new blood vessels grow in the~     retina at the back of the eye and can leak. Such changes in blood vessels are seen in other~     diseases associated with changes in a body chemical called vascular endothelial growth factor~     (VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease,~     age-related macular degeneration, with similar changes in eye blood vessels.~      People 18 years of age and older with macular telangiectasia in both eyes and new blood~     vessel growth in at least one eye may be eligible for this study. They must have vision~     better than 20/400 in the study eye.~      Participants undergo the following procedures:~        -  Ranibizumab injections in the study eye at least four times over 12 weeks. Depending on~          the response to treatment and the side effects, additional injections may be given every~          4 weeks for up to 1 year. The eye is numbed before the injection and the eye area is~          cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection~          to prevent infection.~        -  Evaluations before starting treatment, at the time of each injection, and 8 weeks after~          the last treatment:~             -  History and physical examination.~             -  Eye examination with dilation, microperimetry and photography: The eye examination~               measures visual acuity, eye pressure and eye movements. For the microperimetry~               test, subjects sit in front of a computer screen and press a button when they see a~               light on the screen. Measurements and photographs of the retina are also taken.~             -  Fluorescein and indocyanine green angiography to examine the blood vessels in the~               eye: A dye called fluorescein or indocyanine green is injected into a vein in the~               arm. The dye travels through the veins to the blood vessels in the eyes. A camera~               takes pictures of the dye as it flows through the blood vessels.~             -  Pregnancy test: Women who are able to become pregnant have a urine pregnancy test~               before each ranibizumab injection.~   "
219529|NCT00685490|"~     To evaluate the long term outcomes of pars plana vitrectomy (PPV), with and without internal~     limiting membrane (ILM) peeling, in eyes with persistent macular edema secondary to branch~     retinal vein occlusion (BRVO).~      Results suggest the following hypothesis:~        -  PPV, with and without ILM peeling, appears to be beneficial in eyes with persistent~          macular edema due to BRVO~        -  Effectiveness is maintained long term~        -  ILM peeling does not significantly affect postoperative best corrected visual acuity~          (BCVA)~   "
219596|NCT00684619|"~     The purpose of this study is to determine whether Nelarabine is effective in the treatment of~     patients with T-ALL/NHL in order to achieve a complete remission followed by an early stem~     cell transplantation.~   "
219530|NCT00685477|"~     This is a clinical research study to establish normal values for the infusion of a synthetic~     form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is~     released from the small bowel to stimulate the pancreas and gallbladder to help digest and~     absorb food. Some people have gallbladder problems and need to be tested with the synthetic~     cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out~     how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying.~     The findings in normal subjects will be used to establish normal values that can then be~     compared with patients with suspected gallbladder disease.~   "
219531|NCT00685464|"~     The aim of this study is to investigate wether intracoronary use of bolus Abciximab is~     superior to intravenous bolus in patients undergoing percutaneous coronary intervention.~   "
219532|NCT00685451|"~     The purpose of this phase of the study is to assess the feasibility of a cognitive behavioral~     therapy for post-traumatic stress disorder (PTSD) in persons receiving outpatient services at~     an addiction treatment program. The next phase of the study will be a more rigorous~     investigation of the efficacy of the PTSD therapy within addiction treatment settings.~   "
219533|NCT00685438|"~     With the increasing tourism and adventure travel into extreme environments comes the need to~     reassess the required protection against ultraviolet (UV) radiation and possible other~     oxidative stresses. This is an observational study of UV radiation exposure and skin erythema~     while at extreme altitude (Mt. Everest). In addition to UV exposure, skin erythema,~     antioxidant use (such as vitamins C and E) will be measured.~      Hypothesis:~        1. UV radiation at extreme altitude has larger effects on the skin than at sea level;~          therefore requiring an adjustment of the antioxidant use for adequate protection.~        2. The skin is an accurate reflection of UV and oxidative stress exposure~        3. The efficacy of oxidatives stress is reflective of the ethnicity of the individual.~   "
219534|NCT00685425|"~     The purpose of this study is to investigate, using an exercise challenge approach, the dose~     response of levalbuterol HFA MDI in adolescent and adult subjects with asthma~   "
219535|NCT00685412|"~     DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages~     over traditional vaccines such as live attenuated virus and recombinant protein-based~     vaccines. DNA vaccines appear to be well tolerated in humans. Therefore, we have developed~     our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV~     subtypes 16 and 18. We have chosen to deliver our candidate vaccines via electroporation (EP)~     using the CELLECTRA™ constant current device to deliver a small electric charge following~     intramuscular (IM) injection, since animal studies have shown that this delivery method~     increases the immune response to our DNA vaccine leading to a decrease in the size of tumors~     caused by HPV 16 and 18. The vaccine is proposed to be given to patients with a history of~     CIN 2 and 3 that have been treated by surgery. We will determine which dose the DNA vaccine~     will be the best tolerated and elicit the strongest immune response.~   "
219536|NCT00685399|"~     This study was performed to evaluate the efficacy and safety of AIN457 for patients with~     active uveitis that requires systemic immunosuppression.~   "
219537|NCT00685386|"~     The purpose of this study it to conduct a randomized, controlled, double-blinded trial of~     carbon dioxide (CO2) versus air insufflation during endoscopic retrograde~     cholangiopancreatography (ERCP).~   "
219538|NCT00685373|"~     This will provided long-term safety and efficacy data for ACZ885 (a fully human~     anti-interleukin-1β [anti-IL-1β] monoclonal antibody) given as an injection subcutaneously in~     patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or~     CACZ885D2304(NCT00465985) studies or newly identified patients with the following~     cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome,~     Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease.~      The duration of this study was 6 months with a maximum duration of 2 years~   "
219539|NCT00685360|"~     This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of~     multidrug resistant tuberculosis (MDR TB) for 56 days. In addition to an optimized background~     regimen (OBR).patients will receive will be randomized to:~        -  100 mg OPC-67683 BID~        -  200 mg OPC-67683 BID~        -  placebo BID After 56 days subjects will complete their OBR.~   "
219540|NCT00685347|"~     The purpose of this study is to investigate, using an exercise challenge approach, the dose~     response of levalbuterol HFA MDI in pediatric subjects with asthma~   "
219541|NCT00685334|"~     This study will compare the effectiveness of two atypical antipsychotic medications,~     olanzapine and aripiprazole, in treating people with anorexia nervosa.~   "
219542|NCT00685321|"~     Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep~     brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia~     (deficit syndrome), currently treated with atypical antipsychotics.~      Patient Population: The intention is to treat 45 patients diagnosed with schizophrenia, who~     are currently suffering mainly from negative symptoms and cognitive deficits (deficit~     syndrome). The patients will be of all racial, ethnic and gender categories, ranging from 18~     to 65 years of age, and have PANSS negative≥21 and PANSS positive<24. Patients will be~     recruited from both academic and private research centers.~      Structure: The study is a randomized, prospective, 8 weeks, double blind study. Blinding: The~     treatment administrator and the study personnel and patients will be masked to the treatment~     being administrated.~      Concurrent Control: The study group will receive active rTMS treatment and the control group~     will receive an inactive, sham treatment.~   "
219543|NCT00685308|"~     This is a prospective, multi-center, non-randomized trial to study one-year outcomes of the~     Wingspan system for the treatment of Chinese patients with symptomatic atherosclerotic severe~     intracranial stenosis.~   "
219544|NCT00685295|"~     Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does~     the comparator Percocet~   "
219545|NCT00685282|"~     The general hypothesis of the research is that stress decreases fertility and that Cognitive~     Behavioral Therapy will reduce stress and increase fertility. Secondarily, we hypothesize~     that stress has a detrimental effect on DNA integrity and that stress reduction will reduce~     DNA damage in the cell.~   "
219546|NCT00685269|"~     The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with~     mild to moderate OSAS.~   "
219548|NCT00685243|"~     1. Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of~          surgical scars, both in terms of pigmentary and textural changes.~        2. Evaluate the efficacy of the V-Beam Pulse Dye laser, a standard non-ablative laser which~          is utilized for the treatment of the erythematous and telangiectasia component of~          surgical scars.~        3. Comparison of the outcome of the half of the surgical scar treated with Fraxel SR laser~          versus the outcome of the contralateral half of the surgical scar which will be treated~          with the V-Beam Pulse Dye Laser.~   "
219549|NCT00685230|"~     There is no FDA approved therapy for the treatment of scorpion envenomation, Centruroides~     scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging~     from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical~     syndrome which may require sedation with benzodiazepines and observation for 6 to 28 hours of~     intensive care monitoring. A safe therapy is necessary to halt the progression of symptoms~     early in the clinical course while avoiding the clinical deterioration that can occur en~     route to a tertiary facility. Alacramyn® is anticipated to be safer and more effective than~     the present standard of care, midazolam, and faster-acting such that the need for transport~     of most rural patients will be eliminated and will reduce hospitalization time.~      The working hypotheses are as follows:~        1. The investigational antivenom is safe as treatment of scorpion sting envenomation.~        2. The investigational antivenom is effective as treatment of scorpion sting envenomation.~   "
219550|NCT00685217|"~     This randomized multi-centre trial will recruit women with stress urinary incontinence who~     need surgical treatment for their condition. 300 women will be allocated either to receive a~     TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the~     procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after~     surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists,~     urologists and general obstetrician-gynaecologists: all clinicians will have received~     adequate training.~   "
219551|NCT00685204|"~     Milataxel is a new taxane that may have several advantages over the currently available~     taxanes. The current study is designed to determine the response rate of oral Milataxel in~     patients with malignant Mesothelioma. The study specifically targets patients who have~     recurring or progressive disease following previous chemotherapy.~   "
219552|NCT00685191|"~     The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating~     raltegravir-based salvage therapy and quantify the corresponding changes in levels of~     cellular HIV-1 DNA.~   "
219553|NCT00685178|"~     This is an outpatient clinical trial of topiramate for addressing cocaine dependence and~     reduction of cocaine associated behaviors in opiate dependent drug users maintained on~     methadone treatment.~      The study aims to answer whether topiramate~        1. is safe and acceptable to methadone patients~        2. reduces cocaine use~        3. helps with collateral problems such as alcohol abuse, tobacco dependence, anxiety, PTSD~          and/or pain symptoms. The study will also evaluate topiramate effect on neuro-cognitive~          performance.~   "
219554|NCT00685165|"~     The purpose of this study is to compare the bioequivalence of a test formulation of primidone~     tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets)~     in adult subjects under fasting conditions.~   "
219555|NCT00685152|"~     This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and~     safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for~     6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after~     six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD~     Scale (CAPS) in both active and control groups.~   "
219556|NCT00685139|"~     The purpose of this study is to evaluate and compare the relative bioavailability of a test~     formulation of zonisamide capsules to an equivalent dose of a reference formulation,~     Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting~     conditions.~   "
219557|NCT00685126|"~     The purpose of this study is to compare the efficacy of two dose levels of levalbuterol~     compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48~     months old.~   "
219558|NCT00685113|"~     This is a multicenter study to evaluate the efficacy and safety of 2 different doses of~     DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this~     will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up~     period. Subjects will have physical and laboratory exams, including blood draws at each~     scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4~     weeks) and to keep a daily record of their toilet voids (including time,type and volume) for~     3 days at several specified time points.~   "
219559|NCT00685100|"~     Background: To identify characteristic morphological changes of the retina, their change over~     time and the association with visual function after combined photodynamic therapy (PDT) and~     intravitreal triamcinolone (IVTA).~      Methods: In this retrospective study, 40 patients (40 eyes) were treated with PDT and same~     day IVTA. Optical coherence tomography (OCT), fluorescein angiography (FA) and evaluation of~     distance visual acuity (VA) were performed. Main outcome measures were the anatomical changes~     within intra- and subretinal compartments and their detailed analysis and grading.~   "
219560|NCT00685087|"~     To prospectively define the natural history and the clinical, laboratory and~     histomorphometric features of chronic pancreatitis (CP) of varying etiology. To identify~     clinical and laboratory parameters that correlate with the pathophysiologic state in patients~     with CP. To quantify the behavioral abnormalities associated with CP. To determine~     psychological and behavioral correlates of CP disease progression and outcomes.~   "
219561|NCT00685074|"~     The purpose of the study is to see if a brief computer program can help new mothers cut down~     or quit tobacco, alcohol, or drug use.~   "
219562|NCT00685061|"~     To compare in a randomized prospective study the effectiveness and toxicity of Thymoglobulin~     vs. Campath-1H used for induction therapy vs. our conventional therapy in recipients of first~     cadaver (CAD) kidneys.~   "
219597|NCT00684606|"~     The purpose of the present study is to evaluate the possible benefit of concurrent IV~     Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.~   "
223218|NCT00636935|"~     To explore the effects of corticosteroid therapy on pulmonary fibrosis and potentially~     pneumothorax in patients with mild PCP (pO2 >70mmHg) combined with the standard of care~     treatment of antibiotic therapy.~   "
219563|NCT00685048|"~     This project evaluates the efficacy of brief interventions for individuals seeking treatment~     for substance use disorders who also have gambling problems. In total, 220 problem gambling~     substance abusers will be randomized to one of three conditions: (a) a control condition~     consisting of 10 minutes of psychoeducation about gambling, (b) 10 minutes of brief advice~     about problem gambling and how to reduce it, or (c) four session of motivational and~     cognitive-behavioral therapy. Gambling, substance use and psychosocial problems will be~     assessed using standardized instruments at pre-treatment, month 2, 5, 8, 12, 16, 20 and~     24-month follow-up evaluations.~   "
219564|NCT00685035|"~     Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher~     inflation pressures combined with both low and high oscillator frequencies will result in~     greater sputum production compared to sine waveform HFCWO with lower inflation pressures and~     mid-frequency oscillations.~   "
219565|NCT00685022|"~     The purpose of this study is to compare the safety and tolerability of levalbuterol HFA~     metered dose inhaler (MDI) versus racemic albuterol HFA MDI.~   "
219566|NCT00685009|"~     Excessive memory decline or dementia affects an increasing number of women as they become~     older. The frequency of dementia doubles every 5 years beginning at age 60, making the~     discovery of ways to prevent or slow the disease imperative. Previous studies have indicated~     that changes in memory may be associated with the female hormonal decline that occurs after~     menopause, but more research is needed to establish the link between menopause and poorer~     memory function. It is believed that taking the female hormones estrogen and/or progesterone~     may help improve women's health by protecting against memory decline. This study will~     evaluate the effects of female hormone replacement therapy (HRT) on the development and~     progression of memory loss in older women enrolled in the Women's Health Initiative (WHI)~     study.~   "
219567|NCT00684996|"~     This phase I/randomized phase II trial is studying the side effects and best dose of~     bevacizumab and to see how well it works when given together with or without MEDI-522 in~     treating patients with unresectable or metastatic kidney cancer. Monoclonal antibodies, such~     as bevacizumab and MEDI-522, can block tumor growth in different ways. Some block the ability~     of tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Bevacizumab and MEDI-522 may also stop the growth of tumor~     cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more~     effective when given together with or without MEDI-522 in treating kidney cancer.~   "
219568|NCT00684983|"~     This randomized phase II trial studies capecitabine and lapatinib ditosylate to see how well~     they work compared with capecitabine, lapatinib ditosylate, and cixutumumab in treating~     patients with previously treated human epidermal growth factor receptor 2 (HER2)-positive~     stage IIIB-IV breast cancer. Drugs used in chemotherapy, such as capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Lapatinib ditosylate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as cixutumumab, can block the ability of tumor cells to grow and spread. It~     is not yet known whether capecitabine and lapatinib ditosylate are more effective when given~     with or without cixutumumab in treating breast cancer that has spread nearby or to other~     areas of the body.~   "
219569|NCT00684970|"~     Hamsa-1™ is an anti-angiogenic drug combination designed for the treatment of cancer. The~     investigational product Hamsa-1™ comprises of four well-known active components. The therapy~     is administrated at a unique dosing regimen that was found to be effective and advantageous~     in terms of safety.The product is formulated as an oral suspension, conveniently~     administrated by the patients at home and not requiring medical staff assistance. This Phase~     IIb clinical trial aims to evaluate the efficacy of Hamsa-1™ for the treatment of metastatic~     Castration Resistant Prostate Cancer (CRPC) patients.~   "
219570|NCT00684957|"~     The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1~     (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors~     differently.~   "
219571|NCT00684944|"~     This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or~     moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment~     in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each~     individual patient will continue for as long as the treating physician feels there is benefit~     to the patient. This current protocol covers each patient for 12 months in the first~     instance.~   "
219572|NCT00684931|"~     The aim of this study is to investigate the integrity of connectivity between the neocortex~     and the cerebellum in the Attention Deficit Hyperactivity Disorder (ADHD). Fibers integrity~     will be measured using magnetic Resonance Imaging Techniques.~   "
219573|NCT00684918|"~     This protocol will evaluate the efficacy of obatoclax in older patients with previously~     untreated AML.~   "
219574|NCT00684905|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such~     as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant~     radiation therapy kills tumor cells by placing material such as radioactive iodine directly~     into or near a tumor. Giving leuprolide and bicalutamide together with implant radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving leuprolide and~     bicalutamide together with implant radiation therapy and to see how well it works in treating~     patients with locally recurrent prostate cancer after external-beam radiation therapy.~   "
219575|NCT00684892|"~     The purpose of this study is to evaluate the safety and feasibility of the Chartis System in~     measuring air flow and pressures in isolated lung compartments in emphysema patients prior to~     endobronchial lung volume reduction (ELVR).~   "
219598|NCT00684593|"~     This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis~     Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the~     Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin,~     and 4) to determine the multiple-dose pharmacokinetics of Navarixin.~   "
219599|NCT00684580|"~     Progress in the development of curative therapy for pediatric malignancies has resulted in~     increasing numbers of long-term childhood cancer survivors. This protocol is a means to~     provide continuing review of outcome and late toxicity for all patients actively being~     treated and previously treated for childhood cancer at St. Jude Children's Research Hospital.~   "
219576|NCT00684879|"~     This study will explore the factors that influence screening behaviors of adults diagnosed~     with hereditary hemorrhagic telangiectasia (HHT), an inherited condition in which blood~     vessel defects called arteriovenous malformations (AVMs) result in direct connections between~     arteries and veins. Patients most commonly have small AVMs called telangiectases on the~     tongue, face, hands, mouth, and throat and the mucosal linings of the nose and~     gastrointestinal tract. Recurrent nosebleeds are a hallmark of the disease. Large AVMs can~     also occur in various organs, causing sudden and life-threatening complications.~      The study will examine how patients think and feel about their condition and what actions~     they take to screen for internal symptoms of the disease.~      Men and women 18 years of age and older who have HHT may be eligible for this study.~     Participants fill out a 30-minute questionnaire, available in print or online, that includes~     questions about the participant s~        -  beliefs about HHT~        -  actions taken to screen for internal symptoms of HHT~        -  experience with HHT~        -  current health status, family history and demographic information~   "
219577|NCT00684866|"~     The purpose of this study is to compare the safety and tolerability of levalbuterol HFA~     metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years~     of age with asthma~   "
219578|NCT00684853|"~     The purpose of this study is to determine the association of bevacizumab and PDT is safety~     and effective in the treatment of exudative AMD~   "
219579|NCT00684840|"~     The purpose is to study the extent to which stress and other factors, including money, the~     amount of drug available and the amount of work effort, affect drug choice.~      This study will assess whether exposure to yohimbine, a drug stressor, increases opioid~     craving- and -seeking behavior. We will determine whether these behavioral outcomes are~     associated with biobehavioral stress markers: increased saliva cortisol levels,~     cardiovascular response (heart rate and blood pressure), and negative mood state.~   "
219580|NCT00684827|"~     The purpose of this study is to compare the safety and tolerability of levalbuterol HFA~     metered dose inhaler (MDI) versus racemic albuterol HFA MDI.~   "
219581|NCT00684814|"~     The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem~     tartrate tablets to an equivalent oral dose of the commercially available reference drug~     product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.~   "
219582|NCT00684801|"~     RATIONALE: A disease management program may be more effective than standard therapy in~     improving quality of life and controlling symptoms in patients with cancer.~      PURPOSE: This clinical trial is studying a disease management program to see how well it~     works compared with usual care in patients with stage III or stage IV lung cancer, stage III~     or stage IV pancreatic cancer, stage III or stage IV ovarian cancer, or stage III or stage IV~     colorectal cancer, and their caregivers.~   "
219583|NCT00684788|"~     The purpose of this study is to determine whether employment-based naltrexone treatment~     proves effective in promoting depot naltrexone adherence and drug abstinence.~   "
219584|NCT00684775|"~     The purpose of this study is to determine whether employment-based naltrexone treatment~     proves effective in promoting depot naltrexone adherence and drug abstinence.~   "
219585|NCT00684762|"~     The purpose of this study is to evaluate and compare the relative bioavailability of a test~     formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after~     a single oral dose administered under fasting conditions.~   "
219586|NCT00684749|"~     At a national level of 15%, the reoperation rate following augmentation mammaplasty is too~     high. We are conducting a survey to examine the pre-operative methods by which plastic~     surgeons determine implant volume, size, shape and location; and to determine if the Mentor~     BodyLogicTM System can successfully improve outcomes. We will evaluate how measurements~     taken using BodyLogicTM influence choice of implant and whether there are any~     re-operations, particularly for size change. We hypothesize that using this system will help~     surgeons choose appropriate implants that will decrease the rate of reoperations, especially~     for size change.~   "
219587|NCT00684736|"~     Septic shock is a major cause of mortality and morbidity worldwide. Serotonin (5-HT) is~     released by activated platelets into the circulation, and is mediator of endothelial~     dysfunction. 5-HT metabolism is known in immune system via specific 5-HT receptor, also in~     effects on the peripheral nervous system. Kinetic of 5-HT, tryptophan, kynurenine, MAO~     activity and IDO activity in human septic shock was never investigated.~   "
219588|NCT00684723|"~     The purpose of this study is to evaluate and compare the relative bioavailability and~     therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent~     dose of Mevacor® tablets after a single oral dose administered under fed conditions.~   "
219589|NCT00684710|"~     This study will provide an initial assessment of the safety, tolerability, and~     pharmacokinetics (PK) of PAZ-417 after administration of ascending single oral doses to~     healthy young Japanese male and healthy elderly Japanese male subjects.~   "
219590|NCT00684697|"~     Premature infants with iron deficiency if supplemented with more elemental iron than the~     routine 2mg/kg/day will have improved brain development.~   "
219591|NCT00684684|"~     The purpose of this study is to evaluate the safety and feasibility of the Chartis System in~     measuring air flow and pressures in isolated lung compartments during bronchoscopy.~   "
219592|NCT00684671|"~     Only subjects who participated in the primary study will be invited to participate in the~     extension phase and the challenge dose phase of this study.~   "
219593|NCT00684658|"~     The purpose of the study is to compare the effects of a 5-week internet-based coping skills~     training program (TeenCope) with a 5-week internet education program (Managing Diabetes) in~     youth (age 11-14) with type 1 diabetes on intensive insulin therapy.~   "
219594|NCT00684645|"~     Primary objective: to increase knowledge about safety, tolerability, quality of life and~     efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment~     response, hypothyroidism prevalence.The efficacy will be assessed using the Objective~     Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance~     data.~   "
219595|NCT00684632|"~     This study is designed to determine whether KW-2246 is superior to placebo and not inferior~     to immediate-release morphine for the relief of breakthrough pain in cancer patients.~   "
251293|NCT00262678|"~     The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl~     tablets in relieving breakthrough pain in cancer patients.~   "
219602|NCT00684541|"~     Generalized Social Phobia is characterized by severe social anxiety that leads to functional~     impairment (Schneider et al., 1992). Despite its high prevalence, many individuals do not~     receive treatment or are unresponsive to current therapies. Thus there is a clear need to~     continue to develop highly effective and efficient treatments for social phobia. This three~     year project aims to test a computerized treatment for social phobia in a double-blind,~     placebo-controlled study designed to modify interpretation biases that may maintain anxiety.~   "
219603|NCT00684528|"~     Comparison between the effectiveness of one anti-diabetic drug (Metformin, To combination of~     this drug and additional drug (Janufer), In the community setting.~   "
219604|NCT00684515|"~     The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin)~     in Japanese subjects with cerebral infarction. The study will assess incidence and~     tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on~     expression of markers of inflammation.~   "
219605|NCT00684502|"~     The purpose of this study is to investigate the safety and tolerability of AZD2066 using~     multiple escalating dose panels. There will be separate panels for young healthy volunteers~     and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly~     receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After~     the completion of each panel, a Safety Review Committee will decide if the study can proceed~     to the next dose panel.~   "
219606|NCT00684489|"~     Plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate~     in elevating blood pressure and are useful in selecting effective antihypertensive~     therapy.2,3~      The researchers hypothesize that:~        1. Plasma renin-guided therapeutics will improve systolic and diastolic blood pressure~          control in patients with untreated hypertension as well as in patients with treatment~          refractory or resistant hypertension that are managed by Clinical Hypertension~          Specialists.~        2. Renin-guided therapeutics will reduce the number of medications required to maintain~          blood pressure control to <140/90 mmHg in hypertensive patients receiving 3 or more~          medications, while under the care of a Clinical Hypertension Specialist.~        3. Renin-guided therapeutics selection will reduce the total cost of antihypertensive care~          provided by Clinical Hypertension Specialists.~   "
219607|NCT00684476|"~     Maintenance venom immunotherapy administered at 6-month intervals to bee-venom allergic~     patients failed to provide protection from systemic reactions after sting challenges. These~     patients should continue their immunotherapy at 1-3 month intervals.~   "
219608|NCT00684463|"~     The purpose of this study is to evaluate the efficacy and safety of single IV doses of~     Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting~     associated with moderate and highly emetogenic chemotherapy.~   "
219609|NCT00684450|"~     Safe use of cardiopulmonary bypass (CPB) requires massive doses of intravenous unfractionated~     heparin. At end-CPB, residual heparin is neutralized with intravenous injection of protamine~     sulfate. This prospective, randomized, controlled study will be conducted in 82 voluntary~     subjects admitted for elective, first intention, cardiac surgery requiring cardiopulmonary~     bypass. Each will be randomly assigned to one of two groups. The control group will be~     submitted to a standard protamine infusion of 1.3mg :100U of the total heparin dose given~     during bypass. The test group will receive an infusion of protamine (over 15 minutes) until~     activated clotting time (ACT) values (determined every 3 minutes) depict a plateau, sign that~     the optimal protamine to heparin ratio has been attained. The investigators hypothesize this~     new in vivo titration method to be as efficient as the standard protocol (adequacy of heparin~     neutralization, % heparin rebound, bleeding, and transfusion), and potentially safer by its~     ability to prevent protamine overdose and its deleterious impact on platelet function.15~      Principal Objective~      Evaluate a new in vivo method of titration of protamine sulfate.~      Secondary Objective~      Evaluate the impact of this method on the adequacy of heparin neutralization by measuring:~        1. platelet count~        2. postoperative bleeding~        3. transfusion exposure a~        4. incidence of heparin rebound~   "
219610|NCT00684437|"~     Objectives:~      Smokers with varying levels of health literacy as assessed by the S-TOFHLA (i.e., inadequate,~     marginal, adequate) recruited from the community will listen to one of 4 different types of~     messages emphasizing the health consequences of smoking recorded on a computer in the form of~     audio scripts (i.e., a human voice pre-recorded on a computer will read each message).~     Messages written at a 5th to 6th grade reading level will be concurrently presented in~     written form via a computer monitor and be manipulated in terms of 1) emotionality (i.e.,~     primarily fact- vs. primarily emotion-based), and 2) framing (i.e., gain-framed messages that~     highlight the potential benefits of quitting smoking vs. loss-framed messages that emphasize~     the potential costs of failing to quit smoking). Emotionality and framing will be completely~     crossed to create four different types of messages, 1) factual gain-framed (FGF), 2) factual~     loss-framed (FLF), 3) emotional gain-framed (EGF), and 4) emotional loss-framed (ELF).~      The primary objectives are to:~        1. Examine whether main effects emerge for health literacy as assessed by the S-TOFHLA~          (inadequate, marginal, adequate) and the different message types (fact- vs.~          emotion-based and gain- vs. loss-framed) on the primary explicit and implicit outcomes:~          a) intention to quit, and b) implicit and explicit attitudes toward smoking.~        2. Examine whether health literacy interacts with the different types of messages~          (fact-based vs. emotion-based and gain-framed vs. loss-framed) to influence the primary~          explicit and implicit outcome measures: a) intention to quit smoking, and b) implicit~          and explicit attitudes toward smoking.~           A secondary, exploratory aim is to:~        3. Examine potential associations between a) the primary explicit and implicit outcomes,~          and b) the secondary explicit and implicit outcomes: knowledge, risk perception,~          attitudes, self-efficacy, message evaluations, implicit fear of disease, and implicit~          associations between smoking and disease.~   "
219611|NCT00684424|"~     The primary efficacy parameter will be the responder rate, defined as the proportion of~     subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase~   "
219612|NCT00684411|"~     The purpose of this research study is to evaluate the overall response rate to imatinib~     mesylate in participants with relapsed or refractory T cell non-Hodgkin's lymphoma. This drug~     has been used in chronic myeloid leukemia and information from those other research studies~     suggests that it may help to treat T cell non-Hodgkin's lymphoma.~   "
219623|NCT00684268|"~     By chance the investigators found that iv. silibinin has a potent antiviral effect against~     the hepatitis C virus. Based on the results of the dose finding study (published) te optima~     dosing schedule is explored.This study will be evaluate whether the highest active dose given~     for the optimal time combined with standard of care will result in a sustained virologic~     response (=cure of hepatitis C).~   "
219624|NCT00684255|"~     The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative)~     chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family~     donors and matched unrelated cord blood donors) will be well tolerated.~   "
219693|NCT00683345|"~     Fatigue is a prevalent phenomenon in Primary Sjøgrens syndrome (PSS). Observations indicate~     that the cytokine IL-1 is of importance for this phenomenon. In this study the investigators~     block IL-1 by giving Anakinra (an IL-1 receptor antagonist) to patients with PSS.~   "
219613|NCT00684398|"~     This study aims to understand predictors of adaptation and quality of life among adults~     affected with neurofibromatosis type 1 (NF1) and autosomal dominant neurocutaneous condition.~     NF1 carries a significant psychosocial burden for affected individuals. Aspects of NF1 that~     are especially challenging include the unpredictable nature of the disease, variability in~     severity of symptoms and medical complications, uncertainty in progression, and vulnerability~     to stigmatization due to the highly visible and often cosmetically disfiguring features of~     the condition. The literature suggests that because of these and other challenges posed by~     NF1, affected individuals may struggle to adapt to their condition and, consequently,~     experience poor quality of life. In this study, Lazarus and Folkman s Tranactional Model of~     Stress and Coping is used as a framework to conceptualize adaptation and quality of life to~     NF1. A cross-sectional design with quantitative methodology will be employed to investigate~     the relationships of appraisals and stigma as predictors of adaptation and quality of life.~     Adults affected with NF1 will be recruited via regional and national NF organizations and~     websites, as well as through ongoing NIH clinical research protocols for NF1. Eligible~     participants will be invited to complete a web-based, self-administered survey....~   "
219614|NCT00684385|"~     The purpose of this study is to provide ZD1839 for those patients with locally advanced~     and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent~     and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded~     access basis due to their inability to meet eligibility criteria for on-going recruiting~     trials, inability to participate in other clinical trials (e.g., poor performance status,~     lack of geographic proximity), or because other medical interventions are not considered~     appropriate or acceptable.~   "
219615|NCT00684372|"~     Hypothesis: Early detection, and treatment, of BK virus infection after kidney~     transplantation will prevent BK virus associated kidney transplant injury.~      BK virus associated nephropathy (BKVN) is estimated to cause a progressive kidney transplant~     injury in 1-10% of renal transplant recipients. Diagnostic and monitoring strategies for BKVN~     is still being developed. Detectable virus in the blood by polymerase change reaction-test~     (PCR) is predictive of BKVN. Additionally, PCR provides a objective estimate of the degree of~     infection.~      If early detection and treatment of BK virus infection is effective in preventing subsequent~     kidney transplant injury has not been studied. However, renal injury and dysfunction develops~     late in the natural course of BKVN and it seems likely that screening in combination with~     early treatment would be beneficial for long-term transplant survival.~      There is no established treatment for BK virus infection. Nevertheless, in kidney~     transplanted patients diagnosed with BK virus infection, immunosuppression is reduced to~     allow the patients own immune system to handle the virus. However, reduction of~     immunosuppression has not been associated with rejection. This indicate that these patients~     were over-immunosuppressed, predisposing them to BKVN. Therefore, to compare the degree of~     immunosuppression in BKVN patients (over-immunosuppressed) to other patients (not~     over-immunosuppressed) could yield interesting information. One possibility would be to~     quantify these patients specific cellular immune response to BK virus but also to other~     viruses (T cell reactivity).~      Leflunomide (Arava) is an immunosuppressive drug, approved for the treatment of rheumatoid~     arthritis, and has been used in more than 300,000 patients worldwide. Furthermore,~     leflunomide has been used safely in humans after clinical kidney and liver transplantation~     for more than 300 days. In addition to leflunomide's value in preventing rejection, it has~     been shown to exert inhibitory effects on different viruses. Recently published pilot studies~     suggest that leflunomide treatment of patients with BKVN significantly reduces the amount of~     BK virus in blood and prevents recurrence of kidney transplant injury. At Karolinska~     University Hospital, leflunomide has been used for treatment of BKVN and, in some of the~     patients, renal function has stabilized and BK virus load has decreased significantly.~   "
219616|NCT00684359|"~     Single center randomized parallel group study to determine if:~        1. there is a temporary increase in platelet reactivity after abrupt discontinuation of~          clopidogrel due to a potential rebound phenomenon.~        2. the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty~          with adjunct drug eluting stent implantation compared to 12 month continuation of~          clopidogrel on platelet reactivity. And the association with MACE up to 12 months post~          coronary angioplasty.~   "
219617|NCT00684346|"~     The purpose of this study is to determine if 18Fluorodeoxyglucose (FDG) Positron Emission~     Tomography (PET) imaging can detect changes in airways inflammation in Cystic Fibrosis (CF)~     patients after treatment for a pulmonary exacerbation.~   "
219618|NCT00684333|"~     Subcutaneous injections are a widely used method for drug delivery. One of its major~     drawbacks is the pain inflicted during the process. Sindolor has developed the chemical-free~     EZ-Ject Injector device, based on employing cutaneous local anesthesia on the injection site~     by an electronic anesthetic system. The purpose of this study is to determine the safety and~     efficacy of the EZ-Ject for subcutaneous injections.~   "
219619|NCT00684320|"~     Generalized Social Phobia is characterized by severe social anxiety that leads to functional~     impairment (Schneider et al., 1992). Despite its high prevalence, many individuals do not~     receive treatment or are unresponsive to current therapies. Thus there is a clear need to~     continue to develop highly effective and efficient treatments for social phobia. This three~     year project aims to test a computerized treatment for social phobia in a double-blind,~     placebo-controlled study designed to modify attention biases that may maintain anxiety.~   "
219620|NCT00684307|"~     The main purpose of this study is to provide dose-guiding information by assessing the safety~     and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of~     AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for~     an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial~     fibrillation (AF) with one or more additional risk factors for stroke.~   "
219621|NCT00684294|"~     Preliminary studies with a variety of vaccines suggest target accessibility (potential~     immunogenicity) in a variety of solid tumors to immune directed approaches. However, four~     primary factors limit the generation of effective immune mediated anticancer activity in~     therapeutic application:~        1. identifying and/or targeting cancer associated immunogen(s) in an individual patient~        2. insufficient or inhibited level of antigen presenting cell priming and/or presentation~        3. suboptimal T cell activation and proliferation~        4. cancer-induced inhibition of the anticancer immune response in both afferent and~          efferent limbs.~      In an effort to overcome these limitations, we have designed a novel autologous vaccine to~     address inability to fully identify cancer associated antigens, antigen recognition by the~     immune system (i.e. antigen to immunogen), effector potency, and cancer-induced resistance.~     We have completed clinical investigations using two different gene vaccine approaches to~     induce enhancement of tumor antigen recognition which have demonstrated therapeutic efficacy.~     Specifically, both the use of a GMCSF gene transduced vaccine and a TGFβ2 antisense gene~     vaccine, in separate trials, have demonstrated similar beneficial effects without any~     evidence of significant toxicity in advanced cancer patients. The GMCSF transgene directly~     stimulates increased expression of tumor antigen(s) and enhances dendritic cell migration to~     the vaccination site. TGFβ2 blockade following intracellular TGFβ2 antisense gene expression~     reduces production of immune inhibiting activity at the vaccine site. These agents have never~     been used in combination but the rationale of integrating enhancement of an anticancer immune~     response concurrently with a reduction in cancer-induced immune suppression is conceptually~     sound. We will harvest autologous cancer cells from patients with advanced refractory cancer.~     We have constructed a TGFβ2 antisense / GMCSF expression vector plasmid and have successfully~     demonstrated preclinical activity of the vector function following transfection by~     electroporation and irradiation of autologous cancer tissue.~   "
219622|NCT00684281|"~     The aim of this project is to follow cohort of patients with aMCI in order to establish~     whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory~     profiles and profiles of mesiotemporal atrophy and metabolic change~   "
219625|NCT00684242|"~     The goal of this clinical research study is to learn if lenalidomide can help to treat~     uncontrolled pain caused by advanced cancer.~      Primary Objectives:~      1. Determine efficacy of Lenalidomide for the treatment of refractory cancer pain, as~     measured by the change on Edmonton symptom assessment scale (ESAS).~      Secondary Objectives:~        1. To determine the effect of Lenalidomide on fatigue, sleep, depressed mood, nausea and~          appetite/anorexia.~        2. Determine changes in serum levels of inflammatory cytokines (IL-1beta, IL-6, TNF-alpha,~          interferon(IFN)-alpha and IFN-gamma, and C-reactive protein) before and after treatment~          with Lenalidomide.~        3. Effect of Lenalidomide on T-cell subsets especially T-regulatory cells~        4. Effect of Lenalidomide on the expression of costimulatory receptors, CD80, CD86, and~          CD40, on myeloid and plasmacytoid dendritic cells~        5. Safety (type, frequency, severity, and relationship of adverse events to study~          treatment)~   "
219626|NCT00684229|"~     This study will compare recurrence rates in patients with colorectal cancer who will be~     randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to~     general anesthesia followed by opioid analgesia.~   "
219627|NCT00684216|"~     This trial studies the effects on quality of life and on time to second progression of the~     sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment.~     It is anticipated that the time on study (which is the time between randomization and the~     discontinuation of the second treatment in the sequence) will be similar for both arms of the~     study. The quality of life during this period, however, could be better in the patient group~     receiving the most effective first agent in the sequence. If this proves to be true, the~     conventional wisdom that endocrine therapy should be continued until no further endocrine~     options remain, must be abandoned.~   "
219628|NCT00684203|"~     The study is designed to assess safety and effects of vorapaxar, when added to standard of~     care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study~     may also provide information about the effect of vorapaxar on preventing heart attack and~     stroke in this subject population.~   "
219629|NCT00684190|"~     The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or~     not, i.e. show the same or altered plasma concentration profiles when co-administered~     compared to administered alone.~   "
219630|NCT00684177|"~     The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin~     ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which~     includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of~     age and older will be treated with topical retapamulin or placebo ointment twice daily for 5~     days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14;~     7-9 days after the end of therapy) in the intent-to-treat clinical population.~   "
219631|NCT00684164|"~     Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in~     particular those with neurological injury. Hyponatremia has been associated with worse~     outcome, problems with memory and concentration and impaired balance. Standard treatment for~     low sodium (salt) levels is to give the patient a salt containing solution thru a catheter~     (small flexible tube) in a vein in the arm or leg. One of the major complications of this~     treatment is excess body fluid which may cause heart problems or accumulation of fluid in the~     lungs and may require additional medications to remove extra water from the body.~      FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic~     conditions. Conivaptan works by excreting free water from the body and thereby produce~     concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated~     specifically in patients with brain injuries. The primary objective of this study is to~     demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of~     hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe~     treatment option.~   "
219632|NCT00684151|"~     The first phase of the study is a hospital-based cross-sectional, epidemiological survey. The~     required sample size is 1,260 patients from 50 hospitals across Thailand. Each of the~     hospital will enroll 10 to 40 consecutive patients, depending on case availability on the~     date conducting the survey, with dyslipidemia and classified as high risk as defined by the~     protocol. Lipid levels will be based on serological analysis conducted by a local laboratory.~      For the second phase, each subject will be followed for survival status at 36 months after~     enrollment. Such follow-up will be done by searching the Thai National Vital Event~     Registration Database using subjects' Population Identification Number. All activities~     regarding case selection and data collection will be done by well trained clinical research~     associates (CRAs). The CRAs are from Khon Kaen University where the Statistical Coordinating~     Center (SCC) for this project is based and are independent of the investigator. Random~     auditing visits will also be performed by auditors independent of the SCC. These are to~     ensure not only high quality data but also protecting right and well being of subjects.~   "
219633|NCT00684138|"~     Randomized, parallel group, subject masked, multi-center six (6) month follow-up study~     comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes~     to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.~   "
219634|NCT00684125|"~     The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular~     surgery is higher than after other cardiac surgical procedures. The aim of this study is to~     evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft~     silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using~     large chest tubes. A prospective randomized trial.~   "
219635|NCT00684112|"~     The primary aim of this study is to determine whether the use of gabapentin will improve~     postoperative analgesia and reduce opioid consumption and side effects in children undergoing~     corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether~     use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases~     persisting pain and improves patient satisfaction.~   "
219636|NCT00684099|"~     This trial will determine the maximum tolerated dose the recommended phase II dose and the~     efficacy of this combination in locally advanced or metastatic NSCLC patients~   "
219694|NCT00683332|"~     The purpose of this study is to collect post-marketing information on the safety of Tygacil~     in Filipino patients.~   "
237506|NCT00446446|"~     To estimate the effect of second-line panitumumab monotherapy on objective response in~     patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).~   "
219637|NCT00684086|"~     We propose a diabetes self-management program evaluation and dissemination project with three~     components.~        1. A six-month randomized trial to evaluate the effect of a community-based small group~          Diabetes Self Management Program (DSMP) on the health related quality of life, metabolic~          control and health care utilization of people with type 2 diabetes.~        2. A long-term (12 month) longitudinal evaluation of the same program.~        3. Two 5 day workshops to train others in California in how to lead and administer the~          program.~   "
219638|NCT00684073|"~     This study is designed to determine if opioid dependent subjects who are already receiving~     Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex®~     to Suboxone®. Subjects who are selected to participate in this study will continue their~     prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the~     study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone®~     (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5).~     The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects~     will continue their pre-study prescribed dosage of Subutex®.~   "
219639|NCT00684060|"~     More than 1 million Americans suffer heart attacks each year. Although current treatments are~     able to stabilize the condition of the heart, none is able to restore heart function as it~     was prior to the heart attack. Adult stem cells, which are immature cells that can become~     many different types of cells, may offer a potential means of reversing or preventing~     permanent damage caused by a heart attack. Recent studies have shown promise in using adult~     stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack,~     but more research is needed to assess the safety and effectiveness of stem cell use and to~     discover the best time to administer treatment. This study will evaluate the safety and~     effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for~     improving heart function in people who have had a recent heart attack and a common procedure~     called a percutaneous coronary intervention (PCI).~   "
219640|NCT00684047|"~     The purpose of this study is to evaluate the safety and hemostasis effectiveness of human~     plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.~   "
219641|NCT00684034|"~     The influence of hemodialysis on oxidative stress, endothelial activation, inflammation and~     on the redox state of lymphocytes should be clarified as well as the putative relationships~     between all these parameters.~   "
219642|NCT00684021|"~     Heart attacks are a leading cause of death for both men and women in the United States. A~     heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot~     that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow~     to the heart can be blocked almost completely and the heart muscle in that area can suffer~     permanent injury or death. Although a percutaneous coronary intervention (PCI) can be used to~     open up the blocked artery and restore blood flow to the heart muscle, there may be a~     significant amount of heart tissue that has been irreversibly damaged. Recent studies have~     shown that adult stem cells from bone marrow may be able to improve heart function after a~     heart attack. This study will evaluate the safety and effectiveness of using adult stem cells~     for improving heart function in people who have had a recent heart attack and a PCI.~   "
219643|NCT00684008|"~     This is a phase I inter-patient dose escalation open labeled study assessing multiple doses~     of CYT107 in patients of at least 15 years of age, who are recipients of HLA matched ex vivo~     T cell depleted bone marrow or peripheral blood stem transplants.~      The dose escalation design is aimed at establishing the absence of significant toxicity and~     to define a biologically active dose in this patient population.~      At each dose level, eligible patients will receive 3 doses of CYT107 injected subcutaneously~     (under the skin of the arm, legs, or stomach) once a week for 3 weeks.~      Groups of three patients will be entered at each dose level of CYT107. Three dose levels are~     planned: 10 mcg/kg/week, 20 mcg/kg/week and 30 mcg/kg/week. Three patients must complete day~     42 of the study at a dose level without a dose limiting toxicity (DLT) before there is~     escalation to the next dose level.~   "
219644|NCT00683995|"~     This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as~     rescue medication for breakthrough pain.~   "
219645|NCT00683982|"~     Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be~     clinically important in time of hospitalization and reduction of duration of diarrhea~     secondary to rotavirus?~   "
219646|NCT00683969|"~     The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients~     with myasthenia gravis receiving prednisone, or other corticosteroids. During the study,~     patients will undergo gradual corticosteroid dose reduction, if they respond to treatment.~     The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
219647|NCT00683956|"~     Numerous efforts have focused on the development of closed-loop systems to control anesthesia~     using the electrical activity of the brain (EEG) and EEG-based parameters as surrogate~     measures of anesthetic depth. New systems have been recently developed to considerably~     improve anesthetic control using model-based, patient-adaptive methods. The purpose of this~     study is to evaluate the clinical efficacy of a new intelligent software, ReinLoop, in~     delivering closed-loop, patient-specific hypnosis.~   "
219663|NCT00683748|"~     After transplantation, if insufficient immunosuppression is achieved, rejection and graft~     loss follows. If to much immunosuppression is given, the patient suffers risk for infections~     and malignancies. Despite careful dosing and monitoring of drug levels, the biological~     effects of the immunosuppression given is difficult to predict and varies significantly. As a~     result, the degree of immunosuppression (or immunosuppressive status) remains unknown and~     clinical problems related to under- or over-immunosuppression are common. Thus, a method to~     determine the degree of immunosuppression would be of great and direct clinical importance~     and the results would be improved. T cells are the principal cells of the immunesystem~     causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell~     reactivity could reflect the biological effects of the immunosuppression and the~     immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence~     against viral diseases. Therefore, data on virus specific T cell reactivity could aid in~     diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a~     clinically useful method to monitor cellular immunity and the degree of immunosuppression~     after transplantation by determinations of the specific T cell reactivity to several~     clinically relevant viruses.~   "
219648|NCT00683943|"~     This study will evaluate the side effects and tolerability of the drug lithium in patients~     with spinocerebellar ataxia type I (SCA1) an inherited disorder caused by loss of nerve cells~     in parts of the brain. Symptoms include ataxia (difficulty walking) and loss of muscle~     coordination and strength. Recent studies suggest that lithium may be helpful in treating~     some SCA1 symptoms.~      People between 18 and 65 years of age with SCA1 who have only difficulty walking or who have~     difficulty walking as well as tremor, hand incoordination or speech problems, may be eligible~     for this study. Participation requires three hospital admissions at the NIH Clinical Center~     and one outpatient visit.~      Participants undergo the following tests and procedures:~      Admission 1 (2-6 weeks)~        -  Medical history, physical examination, blood and urine tests, electrocardiogram.~        -  Evaluation of SCA1 symptoms (balance, walking, dexterity, tremor, memory, mood and~          concentration).~        -  Monitoring of liquid intake and output (urine) and weight changes.~        -  Lithium treatment Start treatment and remain in hospital until the blood level of the~          drug is stabilized; continue treatment at home after hospital discharge.~      Admission 2 (2-4 days, 4 weeks after hospital discharge).~        -  Repeat of some or all of the procedures done at the first admission.~        -  Continue lithium in hospital and at home after discharge, with local physician checking~          laboratory values as needed.~      Admission 3 (2-4 days, 8 weeks after Admission 2).~        -  Repeat of some or all of the procedures done at other admissions.~        -  Stop lithium.~      Outpatient Visit (4 weeks after Admission 3)~        -  Evaluation of SCA1 symptoms.~        -  Blood and urine tests.~   "
219649|NCT00683930|"~     This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally~     twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other~     corticosteroids. During the study, patients had their corticosteroid dose gradually reduced~     if they responded to treatment. The anticipated time on study treatment was 12 months, and~     the target sample size was <100 individuals.~   "
219650|NCT00683917|"~     PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.~   "
219651|NCT00683904|"~     The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity,~     and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with~     non-small cell lung cancer.~   "
219652|NCT00683891|"~     AZUR Pharma has received several reports from practicing psychiatrists prescribing FazaClo~     showing that FazaClo patients start losing body weight instead of keep gaining it, after~     being switched from other clozapine products or other atypical antipsychotics treatments.~     Another important clinical observation reported by doctors is a considerable reduction in~     hypersalivation when FazaClo administration is compared to other antipsychotic treatments.~     Based on the findings described above, and on the real need for effective and safer~     treatments for schizophrenia, AZUR Pharma has decided to design and conduct an observational~     study in a large number of patients taking FazaClo to prove the received clinical reports~     from physicians. Better understanding and evaluation of these beneficial findings are~     necessary to provide physicians information for improved treatment decision.~   "
219653|NCT00683878|"~     The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can~     help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well~     controlled on TZD alone. The safety of this treatment will also be studied~   "
219654|NCT00683865|"~     Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease~   "
219655|NCT00683852|"~     The purpose of this study is to determine whether a reduced dose of aripiprazole is effective~     in treating patients with major depressive disorder~   "
219656|NCT00683839|"~     The study will examine the effectiveness of public health dental practitioners using a brief~     office based intervention designed to help patients quit smoking or smokeless tobacco use, as~     compared to usual care.~   "
219657|NCT00683826|"~     Protein-rich diets appear to show some benefits in promoting weight loss. It is thought that~     increased intake of leucine may account for some of this effect. This study is designed to~     assess whether any of the beneficial effects of dietary leucine supplementation observed in~     mice also apply to humans.~      Specifically, our team would like to determine whether oral leucine supplementation in~     overweight/obese humans increases metabolic rate, reduces body weight, improves glucose~     utilization and/or, reduces circulating fat levels in the blood. We hope that the results~     obtained from this pilot study will highlight the specific aspects of metabolic improvement~     associated with increased daily leucine intake. This study will should provide data that can~     be used to design more definitive trials with regard to dietary leucine supplementation.~      Hypothesis~      This pilot study is designed to accomplish the following two goals:~        1. to assess whether any of the beneficial effects of dietary leucine supplementation~          observed in mice also apply in humans. Specifically, we want to determine whether oral~          leucine supplementation in overweight/obese individuals' increases basal metabolic rate,~          reduces body weight, improves glucose tolerance and/or insulin sensitivity, and/or~          reduces circulating Low-density Lipoprotein (LDL)-cholesterol levels.~        2. To provide data that can be used to design more definitive trials with regard to dietary~          leucine supplementation.~      We hope that the results obtained from this pilot study will highlight the specific aspects~     of metabolic improvement associated with increased daily leucine intake. This would in turn~     lead to more rigorous clinical trials involving larger sample sizes, and with diverse~     populations of different gender, age, and ethnic groups. Future trials may also be directed~     to determine minimal doses and durations of leucine supplementation that are capable of~     achieving clinically significant improvement in the cardio-metabolic risk profile in people.~   "
219658|NCT00683813|"~     Cardiac rehabilitation programs (CRP) are a proven treatment for those with ischemic heart~     disease (IHD). These programs have been demonstrated to improve adherence to regular physical~     activity, a healthy diet and smoking cessation, as well as modify risk factors for IHD such~     as hypercholesterolemia, hypertension, obesity and type 2 diabetes. In addition, CRP are cost~     effective and can result in a 25% reduction in reoccurrence of mortality. Despite the known~     benefits of CRP, as little as 10% to 25% of eligible patients attend these programs. One of~     the main barriers to attendance is proximity to a CRP, as the majority of these programs are~     limited to hospitals in large urban areas. However, cardiovascular diseases do not~     discriminate by geography, resulting in a geographic inequity of care for patients living in~     rural, remote and smaller urban/sub-urban centres. Currently there are no CRP specifically~     designed for patients in rural and remote areas. The use of the Internet may present itself~     as a viable alternative. We have recently completed a pilot study of a virtual CRP (vCRP)~     that demonstrated significant improvements in exercise capacity and risk factors. This~     investigation will study the vCRP in a group of IHD patients who do not have access to~     hospital-based CRP.~      Hypotheses A. Participation in a 4 month Internet-based cardiac rehabilitation program will~     result in significant improvements in exercise capacity compared to usual care, in patients~     with diagnosed IHD.~      B. Participation in a 4 month Internet-based cardiac rehabilitation program will result in~     significant improvements in exercise capacity after one year compared to usual care, in~     patients with diagnosed IHD.~      Study Population Men and women over 18 years will be identified from consecutive in-patients~     of the British Columbia Provincial Heart Centre at St. Paul's Hospital in Vancouver who~     reside in either the Northern Interior or Coast Garibaldi health areas. Patients will be~     eligible if they have IHD, Internet access, no previous experience with cardiac~     rehabilitation and no physical limitations to exercise. A total of 74 patients (37 per group)~     will be recruited and randomized to either usual care, or a 4 month 'virtual' cardiac~     rehabilitation program delivered via the Internet.~      Usual Care Group Patients randomized to usual care will be provided with simple guidelines~     for safe exercising and healthy eating habits, and return to the care of their primary care~     physician. Patients will return at 4 and 16 months later for outcome assessment. There will~     be no contact between the study personnel and usual care patients for the duration of the~     study, nor will there be any attempt to control the level of patient care.~      Intervention The vCRP has been developed to mimic hospital-based CRP and includes online~     intake forms, one-on-one chat sessions with vCRP nurse, dietitian and exercise specialist,~     data collection (exercise heart rate, blood pressure, glucose- if diabetic), peer-support~     group chat sessions, ask-an-expert chat sessions, education, progress reports and online~     resources. Upon randomization to the intervention, patients will receive access to the~     website, a heart rate monitor and a blood pressure monitor and trained in their use. The~     heart rate monitors allow for exercise heart rate data to be stored and downloaded to their~     home computer and then uploaded to the vCRP webserver. The exercise data will be reviewed~     weekly. A letter to the patient's primary care physician will be sent to outline the vCRP~     intervention, the treatment algorithms to be used and indicate under what circumstances the~     vCRP nurse and/or patient may contact them with regards to their management. Patients will~     receive one-on-one counselling by the nurse, dietitian and exercise specialist via chat~     sessions at 3 to 4 week intervals. After the 4 month intervention, patients will be~     discharged into the care of their primary care physician.~      Outcomes Participants will be assessed at baseline, 4 and 16 months for risk factors and~     lifestyle behaviours. The primary outcomes will be the change in exercise capacity as between~     the two groups from baseline to 4 months, and from baseline to 16 months. Exercise capacity~     will be assessed as total time on a symptom-limited exercise stress test.~   "
219659|NCT00683800|"~     The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate~     (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor~     Symptoms (VMS) in menopausal women.~   "
219660|NCT00683787|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more~     effective when given together with or without vandetanib.~      PURPOSE: This randomized phase II trial is studying docetaxel to see how well it works~     compared with docetaxel given together with vandetanib in treating patients with metastatic~     stomach cancer or gastroesophageal junction cancer.~   "
219661|NCT00683774|"~     Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the~     kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating~     DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin~     directly by inhibition of islet insulin release with diazoxide in obese women with PCOS~     1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.~   "
219662|NCT00683761|"~     The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the~     treatment of adult patients with progressive or recurrent malignant gliomas.~   "
219664|NCT00683735|"~     Objective: To assess the effect if co-administration of sitagliptin and metformin compared to~     placebo on the incretin effect (based on the comparison of the insulin secretory response to~     oral glucose load and an 'isoglycaemic' intravenous glucose load). Hypothesis: Treatment with~     co-administration of sitagliptin and metformin provides a greater incretin effect compared to~     placebo.~   "
219665|NCT00683722|"~     The objective of the present study is to establish the safety and efficacy of multiple~     administrations of PROCHYMAL™ (human adult stem cells) in subjects with moderate to severe~     Chronic Obstructive Pulmonary Disease (COPD).~   "
219666|NCT00683709|"~     Bipolar Disorder (BD) and Schizoaffective Disorder (SA) clients.~        -  determine if after 12 months of treatment with clozapine, the BMI changes with clients~          who are councelled as usual regarding weight gain while on Clozapine.~        -  determine if after 12 months of treatment with clozapine, the BMI changes with intense,~          structured councelling about diet and exercise.~   "
219667|NCT00683696|"~     The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on~     mortality and morbidity of subjects with heart failure due to left ventricular systolic~     dysfunction, already receiving optimized HF medication, with a narrow QRS width (< 130 ms)~     and echocardiographic evidence of ventricular dyssynchrony.~   "
219668|NCT00683683|"~     Background: One of the 2010 Impact Goals of the Emergency Cardiac Care (ECC) Committee of the~     American Heart Association is to double survival from cardiac arrest. Currently,~     approximately 60% of adults and 50% of paediatric patients that regain spontaneous~     circulation following cardiac arrest die before leaving the hospital. A key piece of the~     chain of survival is this fifth link; the care of patients post-arrest. Although there are~     several modalities recommended for post arrest care, therapeutic hypothermia is the only~     in-hospital therapy that has been demonstrated in randomized clinical trials to improve~     patient outcome after cardiac arrest. Despite the strong evidence for its efficacy and the~     apparent simplicity of this intervention, recent surveys show that hypothermia is delivered~     inconsistently, incompletely, and with undue delay in hospitals receiving resuscitated~     patients; only 26% of physicians and 26% of hospitals regularly institute a hypothermia~     protocol.~      Primary Objective: To design and apply a knowledge translation program for the 2005 AHA~     guideline on hypothermia post cardiac arrest and enable effective implementation of~     hypothermia in 100% of eligible OHCA patients. The integration of two robust data collection~     systems, which include both pre-hospital and in-hospital indicators, will give complete~     process of care and clinical outcome information for all cardiac arrest patients.~      Primary Endpoint: the proportion of eligible out of hospital cardiac arrest patients cooled~     to 32-34°C within 6 hours of ED arrival.~      Study Design: This project will be implemented through an established research collaborative~     of 43 hospitals in southern Ontario currently participating in the Toronto site of the~     Resuscitation Outcomes Consortium. A stepped wedge study design will be employed, whereby the~     intervention will be rolled-out sequentially to the participating hospitals over a number of~     time periods as sites reach pre-defined benchmarks. The multifaceted KT strategy will include~     1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for~     application of hypothermia, tailored to local needs and policy; 3) Identification of~     perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit~     and 5) Providing timely feedback on benchmarks for hypothermia and outcomes~   "
219669|NCT00683670|"~     The purpose of this study is to investigate a method of using dendritic cells (a kind of~     white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma~     cells.~   "
219670|NCT00683657|"~     This protocol will compare 24 hour glucose control for subject taking saxagliptin and~     metformin extended release (XR) versus metformin XR alone~   "
219671|NCT00683644|"~     There is widespread belief and some evidence to indicate that zinc can successfully treat~     tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of~     this study is to establish the effectiveness of zinc for the treatment of tinnitus in~     individuals 60 years of age and older. Subjects will be randomly assigned to either receive~     zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed~     over to the other group.~   "
219672|NCT00683631|"~     The purpose of this protocol is to provide access to Therasphere treatment for patients with~     liver tumors.~   "
219673|NCT00683618|"~     This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with~     Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and~     history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less~     than 10%, following 6-week treatment and a possible 6 week extension treatment.~   "
219674|NCT00683592|"~     This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is~     designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers~     of treatment response associated with vilazodone use in adult patients diagnosed with MDD by~     the DSM-IV-TR criteria.~   "
219675|NCT00683579|"~     ATN 071 is a prospective cohort study comparing neurocognitive functioning in four groups of~     youth, age 18-24: Two groups with CD4+ T cells above 350 cells/mm3 and HIV RNA >1,000~     copies/ml, one initiating HAART (Group 1) and the other not initiating treatment (Group 2);~     and two groups with CD4+ T cells < 350 cells/mm3, one initiating treatment (Group 3) and the~     other not initiating treatment (Group 4). Groups 2 and 3 represent standard of care. Group 1~     and a portion of group 2 will be co-enrolled in ATN 061 and will be randomly assigned to~     group by that protocol.~   "
219676|NCT00683566|"~     Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is~     abnormally synchronized and rhythmic. The oscillatory activity prevails at 8-30 Hz in~     untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels~     inversely correlates with motor impairment. Moreover, these different levels in BG-cortical~     loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment~     following treatment with dopaminergic drugs and is partially suppressed prior to and during~     voluntary movements. An unanswered question is how do BG-cortical loops become so prominently~     engaged in this oscillatory activity? One possible explanation is that the resonance~     frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that~     oscillations in this band are transmitted particularly well. So we hypothesize loop~     resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement~     and following dopaminergic therapy.~   "
219692|NCT00683358|"~     Feasibility and efficacy of combined modality intervention using chemotherapeutic agent~     gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in~     case of advanced/inoperable or therapy-resistant pancreatic cancer patients.~      Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43,~     respectively.~      HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with~     Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).~   "
219723|NCT00682942|"~     The investigators aim to compare four different lung recruitment techniques (described in~     literature) to Computed tomography scan analysis.~   "
219677|NCT00683553|"~     This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic~     study. The study will be conducted in approximately 10 sites in the United States. Up to 48~     patients at high risk for AKI (CCF score ≥ 5 OR an estimated GFR (eGFR) <60 mL/min/1.73 m2)~     who have undergone major cardiovascular surgery will participate. Patients will receive a~     single IV injection of I5NP or placebo following cardiovascular surgery. I5NP will be~     administered 4 hours (+/- 30 minutes) following removal of the cardiopulmonary bypass machine~     (CBM).~      The duration of the study is approximately 44 days, inclusive of a 14 day screening period.~     Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient~     visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 - 5 and Day 7 or~     hospital discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls~     will be made at 6 and 12 months after date of surgery.~   "
219678|NCT00683540|"~     The Veterans Administration (VA) has embraced the use of implementation research as a~     critical way to improve care by facilitating the adoption of proven medical practices. Yet~     implementation science still remains rudimentary. Challenges exist in judging the success of~     an implementation project. Rather than relying solely on hard outcomes, an investigator must~     also assess how effectively an intervention is put into place at a site. This assessment~     comes via a formative evaluation (FE) plan. The FE plan can contain such diverse data~     elements as the number of fliers distributed about the intervention, how often an~     intervention advocate speaks to participants, the content derived from team meeting notes,~     and themes extracted from focus groups. The diversity of such data elements can appear~     foreign to investigators trained in traditional health services research. The FE plan can~     also lead to confusion about what to measure, when, and how to integrate the various measures~     into a unified whole. Complicating matters is the fact that FE is often qualitative--such as~     interviews, focus groups, and meeting notes which can make data difficult for investigators~     to interpret. Thus, there is a pressing need to provide clarity on how FE is to be used in~     implementation studies. This Short Term Project proposal offers a three-part approach toward~     specifying the best FE practices: first, a systematic review of the literature; second,~     qualitative interviews with VA implementation investigators; and third, a panel discussion of~     national experts, funded through a VA Implementation Collaborative Award. The panel~     discussion will outline FE guidelines based on the researchers expertise, the systematic~     review, and the qualitative interviews.~   "
219679|NCT00683527|"~     To examine if early iron supplementation (starting oral iron at 14 days of life) would~     improve the nutritional iron status(measured by serum ferritin) of very low birth weight~     infants at postnatal age of 60 days, when compared to the standard regime of starting iron at~     2 months of life.~   "
219680|NCT00683514|"~     This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral~     vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either~     two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best~     Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small~     cell lung cancer (NSCLC).~      The primary objective is to compare progression-free survival in both arms, the secondary is~     to evaluate the response rate, overall survival in both arms, to evaluate the safety profile~     in both arms and to assess quality of life by the LCSS questionnaire.~   "
219681|NCT00683501|"~     A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase 1I Study~     to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in~     Previously Untreated Patients with intraocular Hypertension~   "
219682|NCT00683488|"~     This is an exploratory study that will adapt and test a combined cognitive behavioral~     treatment and contingency management intervention for alcohol and/or marijuana abuse for use~     in HIV-infected adolescents.~   "
219683|NCT00683475|"~     The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with~     Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent~     prostate cancer (APIC).~   "
219684|NCT00683462|"~     A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will~     be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with~     DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping~     will be completed at screening and slow metabolisers will be excluded from participation in~     this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made~     during each treatment period. Safety and tolerability assessments will be a major component~     of the trial and all serious adverse events (SAE) will be immediately (within 24 hours)~     reported to both Targacept and to AstraZenca.~   "
219685|NCT00683449|"~     The objective of this clinical study is to examine the safety and effectiveness of~     intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in~     subjects experiencing an acute exacerbation of asthma.~   "
219686|NCT00683436|"~     This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm~     crossover study in patients with primary insomnia.~   "
219687|NCT00683423|"~     The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in~     diabetic patients.~   "
219688|NCT00683410|"~     To collect post-marketing information on the safety of Prevenar in Filipino patients~   "
219689|NCT00683397|"~     Consecutive patients with acute or previous venous thromboembolism are enrolled in this~     registry. Using a standardized questionnaire, clinical data detailing venous thromboembolism~     and contributing VTE risk factors are recorded. Results of technical and laboratory~     investigations including screening for thrombophilic disorders were additionally entered into~     the database.~   "
219690|NCT00683384|"~     The purpose of this study is to collect post-marketing information on the safety of Enbrel in~     Filipino patients.~   "
219691|NCT00683371|"~     Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken~     from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using~     three microarrays in order to detect bacteria, fungi and viruses. Ten control patients with~     normal sinuses will have the same samples taken. The hypothesis is that bacterial, fungal,~     and viral communities present in the maxillary sinus of patients with CRS are significantly~     different from those patients with healthy sinuses, and that microorganisms identified in~     patients with or without CRS will differ from previously published data obtained using other~     techniques.~   "
219695|NCT00683319|"~     RATIONALE: Gathering information about how young patients with ependymoma respond to standard~     combination chemotherapy and learning about the long-term effects of this treatment may help~     doctors plan better treatment.~      PURPOSE: This phase III trial is observing young patients with ependymoma undergoing standard~     combination chemotherapy.~   "
219696|NCT00683306|"~     The purpose of this study is to provide gefitinib treatment to patients who, on completion or~     closure of other gefitinib clinical studies, were either receiving placebo treatment, or are~     continuing on the same dose and regimen of gefitinib established in their preceding study,~     for as long as the patients continue to derive benefit.~   "
219697|NCT00683293|"~     The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic~     hysterectomy regarding operating time peri-operative outcome and costs.~   "
219698|NCT00683280|"~     In total, 70 smokers will be randomized to: standard of care smoking cessation medication~     varenicline alone (an FDA-approved smoking cessation medication) or varenicline plus~     contingency management (CM) (a behavioral procedure with rewards for target behaviors, like~     smoking abstinence). Patients in both conditions will receive varenicline for 12 weeks with~     standard smoking cessation therapy and regular breath and urine sample monitoring for~     smoking. Patients assigned to CM will earn chances to win prizes for each breath sample that~     tests negative for smoking, and urine samples that test negative for smoking will result in~     even greater chances for prizes. More CM patients are expected to achieve and maintain~     abstinence than patients receiving varenicline alone.~   "
219699|NCT00683267|"~     Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in~     patients undergoing total hip replacement~   "
219700|NCT00683254|"~     Commercially-available internal nasal stents placed inside the nostril should produce~     decreased nasal obstruction detectable subjectively (volunteers will fill out a survey) and~     objectively (degree of obstruction will be measured with a rhinomanometer which measure~     resistant of airflow while breathing through nose).~   "
219701|NCT00683241|"~     This study is open to women with recurrent epithelial ovarian carcinoma or primary peritoneal~     cancer. Subjects will be asked to donate either a piece of their tumor or malignant effusion~     in order to make the first part of the vaccine or lysate. If enough of the lystate had been~     collected to make the first part of the vaccine, then subjects may enroll in the study as~     long as they meet the rest of the entry criteria.~      After is determined that a subject is eligible to enroll into the study, you will have to~     donate some blood in order to make the second part of the vaccine. After this, the blood and~     vaccine are mixed together to make the vaccine called DCVax-L. You will be given two dose of~     a drug called Avastin every other week (Avastin will be given through your vein) and a oral~     chemotherapy called Cytoxan. One week after your last dose of oral Cytoxan, you will receive~     3 vaccines given every other week for the next month. After the first two doses of vaccine,~     you will also receive more Avastin. During the study you will be seeing your study team to~     have physical exams, blood drawn in order to monitor your health and have blood drawn for~     research. The study team will contact you for the next 5 years in order to determine how you~     are doing.~   "
219702|NCT00683228|"~     This is a pilot study that aims to~        1. Evaluate the effectiveness of using a structured tobacco cessation education program,~          CEASE (Clinical effort against second hand smoke exposure), NY, delivered by pediatric~          residents in the outpatient continuity clinic of the pediatric residency program in~          reducing the exposure of infants to second hand smoke.~        2. Evaluate the efficacy of using a second hand smoke exposure biomarker, Urine cotinine~          level measurement and feedback as an adjunct to counseling.~   "
219703|NCT00683202|"~     In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian~     responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects~     undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian~     hyperstimulation.~   "
219704|NCT00683189|"~     Objectives/Purpose:~      To determine the safety and efficacy of a Vitamin K (Vit K) antagonist (warfarin) in treating~     Metachromatic Leukodystrophy (MLD).~   "
219705|NCT00683176|"~     The purpose of this study is to evaluate the effect of choline fenofibrate on the regression~     of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with~     diabetic macular edema (DME)~   "
219706|NCT00683163|"~     This study will test in several innovative ways, several different combinations of PTH and~     oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The~     intension is to provide other options for treatment than the current standard 2 year course~     of drug therapy. These options may lead to treatment where the two years of therapy are~     spread over several years.~   "
219707|NCT00683150|"~     Primary Objective:~      The primary objective of the study is to characterize and measure the impact of major surgery~     on the kinetics of endothelial function during the perioperative period. Reactive hyperemia,~     characterized by Digital Thermal Monitoring (DTM), will be utilized to characterize this~     during the perioperative period in patients undergoing major abdominal or thoracic surgery.~     This will attempt to characterize the relationship between impaired endothelial function, the~     extent of surgical insult, and the risk for adverse postoperative outcome.~      Secondary Objectives:~      Secondary objectives of this study will evaluate the following:~        -  The incidence of major complications in correlation to reduced preoperative reactive~          hyperemia~        -  The incidence of major complications in correlation to reduced postoperative reactive~          hyperemia (calculated as absolute value and as the change from baseline [delta]).~        -  It is anticipated that two factors (namely, preoperative cardiovascular risk and the~          extent of the intraoperative inflammatory response) will predominantly contribute to the~          impaired microcirculatory/hyperemic/endothelial function and should therefore be~          accounted for in this study. The correlation between impaired reactive hyperemia and~          these two contributory factors will be evaluated.~             1. Preoperative cardiovascular risk will be assessed using risk scoring systems that~               attempt to infer patient risk according to preoperative co-morbidities, namely The~               ASA Physical Status Classification System24, The Lee Modified Cardiac Risk Index,25~               and The University of Texas M. D. Anderson Cancer Center Modifiers to the Lee~               Modified Cardiac Risk Index (an unvalidated scoring system that considers factors~               unique to the cancer surgical population), and The Metabolic Syndrome. The latter~               represents a larger at-risk patient population who has yet to develop symptomatic~               cardiac lesions (and therefore will not be identified by the Lee modified Cardiac~               Risk Index).~             2. Intraoperative inflammatory response will be assessed using quantitative assays for~               C-RP, and cytokines.~        -  Multivariate analysis will analyze for intraoperative perturbations—including~          hemodynamic (heart rate, blood pressure), temperature, and fluid shifts (blood loss,~          transfusions.~   "
219708|NCT00683137|"~     The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to~     placebo in patients with moderate or severe pain following bunionectomy surgery, and to~     evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures~     and on the occurrence of opioid related symptoms.~   "
219779|NCT00682175|"~     To determine the association of both neurohormonal and hemodynamic alterations associated~     with metabolic abnormalities in acute heart failure syndrome.~   "
219709|NCT00683124|"~     The major clinical problems in patients with Marfan Syndrome (MFS) are aortic root dilation~     (ARD), dissection and rupture. Although the available treatments (beta-blockers, BBs) improve~     the evolution of the disease, they do not protect MFS patients from progression of ARD and~     dissection. A key molecule that negatively influences cell growth, differentiation, survival~     and death in MFS is TGFb which is antagonised by existing drugs employed in the clinical~     practice, the Angiotensin II receptor blockers (ARB).~   "
219710|NCT00683111|"~     Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and~     effective treatment for unstable cardiac patients. However, the major complication was~     gastrointestinal bleeding (GIB) due to peptic ulcer. In the prevention of GIB, anti-ulcer~     drug either H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) were commonly~     prescribed. There has been no prospective controlled study to compare the efficacy of these~     two classes of anti-ulcer drugs.~   "
219711|NCT00683098|"~     Evaluation of long-term results for chronic pain and impairment of daily activities after~     endoscopic total extraperitoneal repair of recurrent inguinal hernia with inguinal pain~     questionnaire (IPQ).~   "
219712|NCT00683085|"~     Pancreatic cancer is the fourth leading cause of cancer death in the United States, and no~     combination therapy is far superior to gemcitabine alone. Vascular endothelial growth factor~     receptor type 1 (VEGFR1) is expressed on the tumor vessels and a candidate of tumor~     vessel-specific peptide vaccination strategy to induce T cell immune response. We conducted~     the study to confirm the safety and efficacy of combined modality intervention using~     conventional dose of gemcitabine with peptide vaccination targeting tumor-vessel specific~     VEGFR1 in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.~      Gemcitabine 1,000 mg/m^2 (body surface area) will be administered on day 1, day 8, day 15,~     day 29, day 36, and day 43, respectively.~      VEGFR1-derived HLA-A*02:01-restricted peptide (VEGFR1-A02-770; TLFWLLLTL) emulsified with~     Montanide ISA51 will be subcutaneously injected twice weekly for 8 weeks (total 16 doses).~   "
219713|NCT00683072|"~     Although patient-ventilator asynchrony is a frequent phenomenon, its course following~     management is unknown. As the aid of a data recording system, we try to observe the~     consequence of patient-ventilator asynchrony following management. Our target is aimed at the~     patients with high asynchronization index ( > 10%) as this group of patients have been shown~     to have prolonged course in intensive care unit and are also prone to be tracheostomized~   "
219714|NCT00683059|"~     The purpose of this study is to determine what effects the drug Abraxane has on bladder~     cancer.~   "
219715|NCT00683046|"~     Objectives:~        1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and~          non-myelo-ablative ablative stem cell transplantation in patients with hematologic~          malignancies.~        2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based~          in vivo T-cell depletion, in patients with hematologic malignancies undergoing~          non-myelo-ablative stem cell transplantation.~        3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion~          and non-myelo-ablative ablative stem cell transplantation in patients with hematologic~          malignancies.~   "
219716|NCT00683033|"~     Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate~     abuse or dependence will meet with research staff on two days for quit preparation sessions~     (2 per day). These sessions include testing a breath sample for evidence of smoking twice~     each day (separated by at least 5 hours), counseling based on Public Health Service (PHS)~     guidelines for quitting smoking during the second session each day, and setting a quit date.~     After these sessions, participants will be randomly assigned to one of two 4-week conditions:~     (a) standard care or (b) standard care plus prize CM for smoking abstinence with the~     opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g.,~     CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed~     throughout the intervention. Follow-up data will be collected through 6-months post-quit~     date.~   "
219717|NCT00683020|"~     To measure the effects of a Medical health plan-directed automated telephone self-management~     support system (ATSM) on patient outcomes among ethnically diverse health plan enrollees with~     diabetes.~   "
219718|NCT00683007|"~     The purpose of this study is to examine how the heart functions when a calculated amount of~     blood is removed and how two fluids, Lactated Ringer's (considered the standard replacement~     fluid) and Hypertonic Saline, re-expand the vascular system.~   "
219719|NCT00682994|"~     The goal of this research study is to learn about any differences in certain health-related~     preferences between patients with cancer and their families.~      The main preferences being studied are how decisions are made about healthcare, as well as~     how much information people want to know about cancer.~      Specifically, researchers will compare questionnaire and interview data from~     Hispanic-Americans living in the United States (the M. D. Anderson part of this multicenter~     study) with Hispanics living in Latin America (in particular, Argentina, Chile, and~     Guatemala).~   "
219720|NCT00682981|"~     The Phase I portion of this protocol will determine the best phase II dose and schedule of~     obatoclax with carboplatin and etoposide in patients with extensive-stage small cell lung~     cancer. The Phase II portion will evaluate the response rate to this regimen.~   "
219721|NCT00682968|"~     Hypertension affects nearly 50 million Americans [1] and is the most common chronic condition~     among veterans. Unfortunately, many patients with established hypertension have poorly~     controlled blood pressure (BP); control rates in the VA are at approximately 70% currently.~     While clinician failure to aggressively manage hypertension through therapeutic~     intensification (clinical inertia, or failure to intensify pharmacotherapy appropriately)~     contributes to poor blood pressure control, even when doctors do intensify therapy, 43-78% of~     patients fail to adhere to recommended therapies, indicating that adherence remains a central~     problem in hypertension care. This suggests important opportunities for interventions to~     improve risk factor control by working through clinicians, their teams, or their delivery~     systems, as well as with patients, to address both patient adherence and clinical inertia.~   "
219722|NCT00682955|"~     This project is aimed to evaluate the efficacy of two different zinc formulations~     (dispersible Zinc tablets versus Zinc suspension) for the treatment of acute diarrhea in~     hospital based settings. Additionally we intend to compare the effectiveness of treatments of~     different groups on the basis of usage of Zinc in the treatment of diarrhoea, and to monitor~     additional treatment components such as ORS, antibiotic usage rates.~   "
219724|NCT00682929|"~     The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral~     cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe~     and effective in reducing the symptoms of spasticity and tremor in patients with~     secondary-progressive or primary progressive multiple sclerosis.~   "
219725|NCT00682916|"~     Obesity and type 2 diabetes have clearly been linked together and identified as epidemics in~     much of the developed world. Historically several different dietary fibers have been used as~     means of reducing body weight and the related development of type 2 diabetes. These studies~     have generated mixed, if not inconsistent, results suggesting that none of these fibers~     promise a solution to either of these two conditions. We are proposing to investigate the~     effects of including a new soluble fiber, a-cyclodextrin, FBCx® (to be called Y288 in this~     study), into the diet of adult overweight volunteers.~   "
219726|NCT00682903|"~     The objective of the project is to evaluate advantages from the use of a bearable continuous~     interstitial glucose monitoring device (GuardianR) during educative sessions of diabetic~     patients dedicated to functional insulin therapy teaching. This concept of intensified~     treatment is based on testing and explanation of simplified decision making algorithms to~     adapt insulin dose to every true life conditions. As self monitoring of capillary glucose~     level is needed to validate those algorithms, we postulate that using a device able to~     permanently control interstitial glucose readable by both medical team and patient himself~     (during the session and the 5 following days after discharge) could significantly improve~     safety and efficiency of such educative session.~   "
219727|NCT00682890|"~     The purpose of this research study is to determine if adding Metformin, a drug that reduces~     insulin resistance, to birth control pills will reduce the risk of developing type 2~     diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS~   "
219728|NCT00682877|"~     The purpose of this study is to determine the correlation between gastric residence time of~     the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled~     meal as measured by gastric emptying scintigraphy for subjects 65 years of age and older.~   "
219729|NCT00682851|"~     This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test~     and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to~     diagnose common vaginal infections.~   "
219730|NCT00682838|"~     Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of~     up to one-fifth of all Veterans. Because of disappointingly low adherence to the~     gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute~     of Medicine has stated that new adherence strategies are needed that improve the quality of~     care, reduce social and economic costs, and help OSA patients live happier, healthier, and~     more productive lives through improved clinical management. The combination of a~     self-management approach along with emerging wireless technologies has strong potential to~     increase treatment adherence and improve outcomes.~   "
219731|NCT00682825|"~     The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and~     Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of~     patients remembering being awake during surgery. The BIS monitor may be able to measure how~     asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be~     compared with using the concentration of anesthetic gas to guide anesthesia.~   "
219732|NCT00682812|"~     The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV)~     viral load.~   "
219733|NCT00682799|"~     This is a prospective, non-randomized multi-center multi-national study to evaluate the~     chimerism measured by STR and SNP in patients with hypoplastic RC and normal karyotype~     transplanted with a preparative regimen of reduced intensity.~      Primary objectives:~        -  To study hematopoietic chimerism in whole blood and different cell population (CD14,~          CD15, CD 56, CD3, CD19) as well as in dendritic cells and regulatory T-cells after SCT~          with RIC in patients with RC~        -  To compare the results of chimerism obtained with standard STR PCR (sensitivity 1%) with~          those obtained with SNP PCR (sensitivity 0.1- 0.01%)~      Secondary objectives:~        -  To evaluate the relationship between mixed chimerism and hematological engraftment, OS~          and EFS~        -  To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T-cells~          on the incidence of acute and chronic GVHD~   "
219734|NCT00682786|"~     Determine if genotype-directed neoadjuvant chemoradiation, using information from the~     thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging~     in high risk patients compared to historical controls.~   "
219735|NCT00682773|"~     Oral anticoagulant therapy with warfarin is essential for the prevention of strokes and other~     thromboembolic events related to various medical conditions; however, use of this therapy can~     be associated with an increased risk of serious bleeding. In a previous AHRQ-funded study, we~     have demonstrated that the prevalence of conditions for which warfarin is indicated is high~     among frail elderly nursing homes residents, use of warfarin in this setting is very common,~     and the quality and safety with which warfarin is used is far from optimal. The research~     described in this application resonates with AHRQ's stated priorities for FY2006. The premise~     underlying the proposed intervention study is that errors in prescribing and monitoring~     warfarin for nursing home residents are related more to problems in the system of care, than~     to deficits in the knowledge base of health care providers. We propose a low technology~     intervention for improving the quality and safety of anticoagulant therapy with warfarin in~     the nursing home setting. The intervention focuses on maximizing the effectiveness of~     communication between the nursing staff and physicians of nursing home residents on warfarin.~     The intervention will build on an established approach for situation briefing drawn from the~     U.S. armed forces: SBAR - Situation, Background, Assessment, Recommendation. We will test the~     effectiveness of this approach through a matched, cluster-randomized trial, with~     randomization at the level of the nursing home. Our study has the following specific aims:~     (1) to determine whether a nursing home warfarin management protocol emphasizing facilitated~     communication to physicians will improve the quality of anticoagulation management, which~     will be assessed using widely accepted quality measures; (2) to determine whether the~     intervention will lower the rates of adverse events (bleeds and thromboembolic events) among~     warfarin-treated residents of intervention group nursing homes compared to control nursing~     homes; and (3) to produce a toolkit for use by nursing homes that will allow dissemination of~     this approach to enhancing the quality and safety of warfarin for the frail elderly. If~     successful, this approach may serve as a model for improving the safety of other medication~     categories associated with high rates of preventable adverse drug events, and for protecting~     nursing home residents, and frail elderly cared for in other settings, who are at special~     risk for medication-related problems.~   "
219780|NCT00682162|"~     Chronic rhinitis without an allergic or infectious aetiology (vasomotor rhinitis) is a common~     disease for which there are only poor therapeutic treatment options. The current placebo~     controlled partially double blinded pilot study evaluated the effects of acupuncture on the~     symptoms of vasomotor rhinitis.~   "
219819|NCT00681655|"~     This study will assess whether the presence of a particular form of a gene, GABRA2, affects~     the functional responses of the human brain to alcohol administration and will evaluate that~     relationship in the context of factors known to increase the risk for future alcoholism.~   "
219736|NCT00682760|"~     To compare the efficacy and safety of Korean botulinum toxin A (KbtxA, Pacific~     Pharmaceuticals, Korea) against Botox in the treatment of essential blepharospasm, we~     performed a double-blinded, randomized, comparative trial comparing KbtxA and Botox for~     treatment of blepharospasm in 60 patients of the intention to treat population and 52~     patients (26 patients from each group) of the per protocol population. The improvement of~     severity of spasm (SS) at 4 weeks post-injection as a primary efficacy outcome, qualifying~     non inferiority to the control group, Changes in eyelid closure force (CF) and functional~     visual status (FVS) after injection for secondary efficacy outcomes, and adverse effects for~     safety evaluation. Improvement of SS was noted in 90.3% of the KbtxA group and 86.2% of the~     Botox group. There were no significant differences between treatment groups in the changes of~     CF and FVS after injection (p>0.05). Adverse effects developed in 16.1% of the KbtxA group~     and 27.6% of the Botox group, but no serious adverse events were found in either group. KbtxA~     was not inferior to Botox in treatment efficacy and was clinically safe with no serious~     adverse effects when used to treat essential blepharospasm.~   "
219737|NCT00682747|"~     The purpose of this study is to determine whether hyperbaric oxygen is effective in the~     treatment of a dry mouth that occured after radiotherapy for head and neck tumours.~   "
219738|NCT00682734|"~     Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do~     not know the best dose to administer. This study compares three different doses of~     metoclorpamide.~   "
219739|NCT00682721|"~     We will be examining the effects of suppressive valacyclovir therapy on the stability of~     vaginal flora in women who are seropositive for HSV-2. We have preliminary data that suggests~     the presence of HSV-2 increases the risk for Group B Streptococcus colonization as well as~     many other deleterious organisms (e.g. Streptococcus pseudoporcinus), in addition to~     increasing the risk for acquisition of BV-associated vaginal flora. We will be examining the~     effects of suppressive therapy on the vaginal flora of any HSV-2 seropositive woman.~   "
219740|NCT00682708|"~     Malnutrition is a critical public health problem in developing countries. Malnutrition may be~     linked to more than one half of the deaths in children under 5 years old. In July 2001, after~     an intervention related to a measles epidemic, Medecins sans Frontieres-France opened a~     nutritional program in Maradi, in the South of Niger. The introduction of ready to use~     therapeutic foods (RUTF), in particular Plumpy'Nut (Nutriset, France) allowed for the~     treatment of the majority of children at their homes using ambulatory treatment. Children~     with complicated cases were cared for in an inpatient center. With ambulatory treatment the~     number of children cared for in the MSF program reached close to 70000 in 2006.~      This study aimed to assess the effect of a 3-month distribution of RUTF in the context of a~     preventative supplementary feeding program. The primary hypotheses were that short-term RUTF~     supplementation at the village-level would prevent declines in weight-for-height and reduce~     the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. Because RUTF~     may have additional health effects, the intervention effect on height-for-age, stunting,~     mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.~   "
219741|NCT00682695|"~     The purpose of this study is to find risk factors for hemorrhagic stroke.~   "
219742|NCT00682682|"~     Ultimately, the purpose of the present study is to help improve pain control in burn patients~     during wound care and physical therapy, where pain levels with opioids alone are often~     excessively high.~      This study measures how much virtual reality pain distraction reduces pain compared to~     traditional opioid pain meds, and whether there is additional pain reduction when Virtual~     Reality distraction + Opioids are combined. In addition to studying the amount of pain~     reduction, this study will also measure side effects (if any) of the two treatments (Virtual~     Reality pain distraction and Opioids) alone and when combined.~      Healthy volunteers will be recruited from advertisements will undergo a trial of the pain~     testing. They will receive a series of brief stimuli (at a painful but tolerable safe~     intensities they select and approve during baseline testing), separated by intervals of no~     pain.~      Participants will rate how much pain they felt after each brief stimulus, and will fill out~     side effects questionnaires after finishing the pain session.~      Subjects will participate in each of the four conditions in which the order is randomized.~        -  No opioids (0ng/ml hydromorphone) + no virtual reality Snow World distraction~        -  No opioids + yes virtual reality Snow World distraction~        -  Moderate dose of pain medicine (4ng/ml hydromorphone) + no virtual reality~        -  Moderate dose of pain medicine + yes virtual reality Snow World distraction~      It is our hypothesis that VR distraction + opioids will show a reduced perception of pain in~     subjects more than opioids alone or no intervention (control).~   "
219743|NCT00682669|"~     Asthma is one of the four most common chronic disorders in adults, affecting 14 million~     adults in the United States and costing an estimated 7.9 billion dollars in medical care and~     5.3 billion dollars in lost work or school. About 40% of asthmatics report using some form of~     complementary and alternative medicine approach to help reduce their asthma symptoms, but~     there is little evidence for their effectiveness. Mindfulness-based stress reduction (MBSR)~     is a group based program shown to reduce medical symptoms and improve quality of life for~     patients with many different chronic diseases. The goals of the proposed randomized~     controlled trial are to collect preliminary data on the effect of MBSR on quality of life,~     symptoms, and lung function in mild and moderate-severity asthmatics and to refine~     recruitment and data collection procedures for a future, larger clinical trial.~   "
219810|NCT00681772|"~     Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection~     sufficient for satisfactory sexual performance. An ideal treatment option should be effective~     and reliable, have minimal side effects, be simple to use and affordable. The aim of this~     study was to investigate safety, tolerability and efficacy of vardenafil following a flexible~     dose treatment schedule in subjects with varying aetiology.~   "
219811|NCT00681759|"~     The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in~     patients with cardiovascular disease taking low dose aspirin~   "
219812|NCT00681746|"~     The study is carried out in order to determine the relationship between the dose of AZD6280~     and the blood concentration of AZD6280, and to investigate to which extent AZD6280 binds to~     GABAA receptors~   "
219813|NCT00681733|"~     1. To assess the metabolic factors in lean and obese patients with NASH.~        2. To compare the efficacy of pentoxifylline versus pioglitazone on the metabolic profile~          and liver histology of NASH patients.~   "
219744|NCT00682656|"~     The adequate treatment of the American tegumentary leishmaniasis is crucial since the~     disease, differently from the caused by the Old World species, is painful and not~     self-healing and may lead to the disfiguring mucosal involvement. So far, pentavalent~     antimony compounds have been considered the treatment of choice for cutaneous leishmaniasis~     (CL), however, these drugs present high frequency of side effects and important disadvantages~     as parenteral administration and need for careful renal and cardiac monitoring. Azithromycin~     is a macrolide antibiotic, non-expensive, largely commercially available that has shown~     in-vitro and in vivo activity against different species of Leishmania.~      The main objective of this study is to evaluate the efficacy and safety of oral azithromycin~     for the treatment of CL. The efficacy of oral treatment of azithromycin 500 mg/day for 20~     days is going to be compared with the standard treatment of intramuscular injections of 20~     mg/Kg/day of pentavalent antimonials (Glucantime®) for 20 days in patients with CL from two~     endemic regions of Brazil: the metropolitan region of Belo Horizonte and Montes Claros (MG)in~     the southeast Brazil and in Corte de Pedras (Bahia), Northeastern Brazil. The patients follow~     up lasts for 12 months.~   "
219745|NCT00682643|"~     The purpose of this study is to assess long-term ocular safety of fluticasone furoate nasal~     spray in adult and adolescent subjects diagnosed with perennial allergic rhinitis.~   "
219746|NCT00682630|"~     The objective of the study is to determine the bioequivalence of the combination of~     pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference~     tablet administered as a single total dose of 720:240 mg in healthy adults.~   "
219747|NCT00682617|"~     Osteoarthritis is the most common form of arthritis in the United States. It is estimated~     that 20 million Americans have arthritis, and the annual societal cost is $95 billion.~     Several exercise studies have shown modest improvements in disability, physical performance,~     and pain in subjects with knee osteoarthritis. While similar results have been suggested in~     hip osteoarthritis, well-designed randomized clinical trials have not been conducted.~     Exercise programs appear beneficial but without adherence, the beneficial effects of exercise~     for knee and hip osteoarthritis decline over time. A well-designed, evidence-based,~     arthritis-specific study controlling for exercise duration, frequency and adherence is~     needed. The objective of this study is to determine the effects of structured exercise~     programs on self-reported pain and disability in adults with hip osteoarthritis. This~     prospective, randomized study with a wait-list control is designed to develop preliminary~     data to support an R01 funding request for a large, randomized clinical trial. All exercise~     interventions and outcome assessments will take place at OHSU in the Orthopaedics and~     Rehabilitation Clinics, Rehabilitation Services physical therapy gym, and the General~     Clinical Research Center. Subjects will be selected to include individuals representative of~     the larger population with documented hip osteoarthritis. This three-month study will~     evaluate the effects of an aerobic and resistance exercise program on pain and disability in~     individuals with hip osteoarthritis. Outcome assessment will follow the Outcome Measures in~     Rheumatology (OMERACT) recommendations for a core set of outcome measures for clinical trials~     in arthritis and assess pain, physical function, patient global assessment, and joint~     imaging. Data analysis will focus on comparing pre- and post-intervention endpoints using~     conventional statistical analyses such as repeated-measure analysis of variance for repeated~     continuous measures (e.g. walking distance), and non-parametric methods such as Chi-square or~     frequency analysis for proportions (e.g. visual pain scores).~   "
219748|NCT00682604|"~     This research had as a goal to characterize the social demographic profile, nutritional~     status, the presence of chronic non-transmissible diseases and food intake of the community~     health agents who belong to five family health units in the east zone of Sao Paulo City.~   "
219749|NCT00682591|"~     Prospective, longitudinal multi-center study performed in 15 participating substitution~     centers in Germany.~      Aims:~      - Primary objective: To compare the impact of the different substitution drugs (methadone,~     buprenorphine, and suboxone) on the neurocognitive, emotional, and quality-of-life-related~     tolerability in opioid dependent patients under HCV treatment.~      - Secondary objective: To investigate if IFN therapy impairs efficacy (with respect to e.g.~     retention rates, concomitant drug use and in particular neurocognitive function) and~     tolerability of agonist maintenance treatment with methadone, buprenorphine, or suboxone~   "
219750|NCT00682578|"~     Malaria is a major public health problem in many provinces of Afghanistan the failure rate of~     chloroquine (CQ) and amodiaquine (AQ) treated Plasmodium falciparum(Pf) malaria has risen to~     more than 60% overall and as high as 90% in Jalalabad. CQ remains fully effective against P~     vivax, and sulphadoxine-pyrimethamine (SP) remains effective against P falciparum (10-15% of~     cases fail to cure). The current malaria treatment protocol still continuing CQ for P.vivax~     and adopted Artmisinine based combination therapy (ACT) for treating (Pf) malaria, as most~     than 50% malaria has being diagnosed clinically, so due to this and other operational reasons~     the protocol needs to be simplified.~      By comparing 56 day PCR corrected cure rate of DHA-PPQ with the standard treatment regimen as~     primary objective and comparing the safety, gametocytecidal effect and parasite clearance~     time as secondary objectives, our study titled: Randomized, Open Label, controlled,~     non-inferiority clinical trial for comparison of Efficacy & safety, will provide scientific~     evidence to lead the simplification and improvement of the standard malaria treatment regimen~     in Afghanistan; to adopt a policy of treating both vivax and falciparum malaria with the same~     drug regimen.~      With a significance level (α) = 0.05 and a power=80%, the calculated sample size is 274 per~     study arm. Therefore about1100 patients (274 per study-arm: 548 patients with falciaprum~     malaria and 548 patients with vivax malaria) will be recruited in Malaria reference Centers~     (MRCs) of three malaria endemic provinces (Nangarhar in the east, Thakhar in the north-east~     and Faryab in the north-west of country) after signing written inform consent form, according~     the inclusion and exclusion criteria and will be treated as out patients by giving the~     randomized drug dose under observation of study team and followed-up daily for 3 days (as~     treatment course of either arm is once daily dose for three days) and after than weekly up to~     day 56. and the study is planed to conducted in 3 provinces of Afghanistan for approximately~     2 years.~      Patients will be assessed clinically as well necessary laboratory tests will be performed and~     all the bio-medical findings will be recorded in special patient case record form, the~     electronic form of which will be broth to Trop. Med of Mahidol University for final analysis.~     The patients will be receiving the reasonable transportation cost for follow-up visits as~     well as one bed-net at the end of enrollment.~   "
219751|NCT00682565|"~     This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy~     patients with angina is deleteriously affected by treatment with CK-1827452.~   "
219752|NCT00682552|"~     Relationship between HPV infection and cervical cancer is well established. Among the HPV~     types identified to date, 15 are classified as high risk HPV (HR-HPV). Detection of HR-HPV~     has been proposed to optimize cervical cancer screening.~   "
219753|NCT00682539|"~     The purpose of this study is to investigate the change in macular edema and the absolute~     change in visual acuity following intravitreal administered injections of Bevacizumab~     (Avastin®) or Ranibizumab (Lucentis®) compared with Triamcinolone (Volon A®) in patients with~     clinical significant diabetic macular edema.~      The investigators monitor the change in macular edema measured with standard optical~     coherence tomography (OCT) and the absolute change in visual acuity analyzed by standardized~     charts according to the protocol used in the Early Retreatment in Diabetic Retinopathy Study~     (ETDRS).~   "
219814|NCT00681720|"~     The study is carried out in order to determine the relationship between the dose of AZD7325~     and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to~     the GABAA receptors.~   "
219754|NCT00682526|"~     Aim: To determine the impact of wireless transmission of prehospital ECGs to a hand-held~     computer on time to treatment and myocardial salvage in acute MI patients.~      Background: The TIME-1 investigators documented a 27% (109 to 80 minutes) reduction of time~     from EMT arrival at the scene to successful primary PCI implementing pre-hospital ECG~     transmission to the ED. ECG transmission directly to a physician's cellular phone/PDA through~     a wireless modem has only recently become an option. The recently completed TIME-NorthEast~     (NE) study tested the Welch Allyn version of this system and the results show a reduction in~     time to reperfusion for acute MI patients by 66 minutes (116 to 50).~      Methods: This study will involve approximately 20 sites around the country. The study will be~     divided into two phases: a consecutive control data collection phase (Phase I) and an~     intervention with concurrent control phase (Phase II). Phase II will begin after installation~     of Welch Allyn ECG transmission equipment. The primary end-point will be time to reperfusion~     and secondary end-points will include myocardial salvage, aborted infarction and hospital~     mortality. ECG measurements will be made at a central ECG core lab by a blinded investigator.~      Data Analysis: Patient characteristics for the three periods were compared with the~     chi-square statistic for categorical variables and one-way analysis of variance for age. The~     Wilcoxon rank-sum statistic was used to compare time-to-reperfusion in the pre-study and~     study periods as well as in the Group 1 post-study period. Comparisons were performed~     separately for EMS and self-transport groups.~   "
219755|NCT00682513|"~     The purposes of this study are to identify persons with rapid-onset dystonia-parkinsonism~     (RDP) or mutations of the RDP gene, document prevalence of the disease, and map its natural~     history.~   "
219756|NCT00682500|"~     This study will determine if administration of an suspension of calfactant, a lung~     surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome~     within 48 hours of requiring mechanical ventilation can decrease the mortality in patients~     with lethal disease and shorten the course of respiratory failure in patients with sub-lethal~     disease.~   "
219757|NCT00682487|"~     Aim of the study:~      To evaluate whether hair cortisol levels are elevated in patients admitted with acute MI~     compared to controls.~      Study steps:~        1. Introduction of the study to the participants and inform consent signing~        2. Collection of clinical and demographic data~        3. Scalp hair sampling- samples will be sent for laboratory analysis~        4. Analysis of the results~   "
219758|NCT00682474|"~     The purpose of this study is to conduct a randomized controlled school-based trial to~     evaluate the effectiveness of a four-session school nurse-delivered smoking cessation~     intervention in increasing abstinence rates among high school students who smoke.~   "
219759|NCT00682461|"~     This study is to evaluate the oral tolerability of a nicotine prototype~   "
219760|NCT00682448|"~     We hypothesize that metformin co-administered with olanzapine will be well tolerated and~     associated with significantly less insulin resistance, weight gain and dyslipidemia as~     compared to olanzapine plus placebo.~   "
219761|NCT00682435|"~     We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone~     followed by an additional 1mg. Eligible patients will be given 1 mg IV hydromorphone. At 15~     minutes, these patients will be asked the question, Do you need more pain medication? Those~     that answer yes will receive an additional 1mg IV hydromorphone. Those that answer no~     will not receive additional pain medications at that time period (15 minutes). Thus, we wish~     to give up to 2 mg IV hydromorphone titrated to patients' pain, which we believe will result~     in less incidence of oxygen desaturation.~      If our study shows that this regimen is safe, its efficacy can be assessed in future trials.~     Positive results of those trials may lead to the use of this regimen to improve pain~     management in the emergency department.~   "
219762|NCT00682422|"~     The aim of this qualitative study is to explore parental and child perceptions of~     participating in a family-based behavioral intervention targeting healthy behaviors.~   "
219763|NCT00682409|"~     Classical imaging techniques are inaccurate to detect residual cholesteatoma. The aim of our~     study is to evaluate the value of diffusion-weighted MR imaging and delayed contrast enhanced~     T1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a~     large serie of surgically verified cases.~   "
219764|NCT00682383|"~     To determine the safety and efficacy of administering filgrastim with concurrent~     chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation~     chemotherapy in patients with unresectable locally advanced NSCLC patients.~   "
219765|NCT00682370|"~     Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor~     modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length~     polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in~     several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1~     stimulation of heme arginate in healthy humans.~   "
219766|NCT00682357|"~     Oral and nasal steroids may enhance osteoporosis by suppressing bone formation.~     Intra-articular steroids may also suppress bone formation, however, the duration or~     relationship to a steroid dose has not been established. It is hypothesized that~     intra-articular steroids suppress bone formation transiently, returning to pretreatment~     levels within four weeks in subjects with osteoarthritis.~   "
219767|NCT00682344|"~     Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The~     goal of this prospective work is to study the pharmacokinetic aspect of this drug after~     injection around the sciatic nerve (subgluteal way).~   "
219815|NCT00681707|"~     This study will address the treatment rate and control rate of hypertension, treatment~     pattern and factors that affect BP control by examining retrospective medical records of~     hypertension patients recovering from stroke, among outpatients coming to the Neurology~     Department in 10 university hospitals nationwide.~   "
219816|NCT00681694|"~     The purpose of this research study is to assess outcomes of treatment for early prostate~     cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments~     in the patients quality of life. In this study we will compare the outcomes of patients~     treated with two alternative brachytherapy (seed implants) techniques using a series of~     questionnaires.~   "
219817|NCT00681681|"~     The purposes of this study are to quantify and compare vascular function in men and women,~     and to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological~     markers and hormonal markers on vascular measures to establish gender-specific models.~   "
219768|NCT00682318|"~     The American Heart Association and the American College of Cardiology (AHA/ACC) recently~     encouraged increased consumption of omega-3 fatty acids in the form of fish or capsule form~     (1 g/day) for risk reduction and stated that for treatment of elevated triglycerides,~     higher doses are usually necessary for risk reduction (Smith SC et al. Circulation~     2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy~     of the omega-3 treatment with data derived from single randomized trials or non-randomized~     studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to~     elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but~     even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama~     2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective~     effects of omega-3 FAs.~      The objective of the clinical study is to study the effects of fish oil on blood and urinary~     markers of inflammation and cell stress. By using different permutations of high-dose~     supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish~     doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3~     fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell~     stress.~   "
219769|NCT00682305|"~     The present study is a multicenter, prospective phase II-study investigating the combination~     of treosulfan, etoposide, and cyclophosphamide as conditioning regimen for patients with~     acute lymphoblastic leukemia who are not eligible for a TBI-containing regimen.~   "
219770|NCT00682292|"~     To compare renal allograft rejection rates during the first year among high-immunological~     risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.~   "
219771|NCT00682279|"~     This is an open-label, Phase I study of oral topotecan administered in combination with~     lapatinib in subjects with advanced solid tumors. This Phase I study will evaluate the~     safety, tolerability, and pharmacokinetics of oral topotecan administered in combination with~     lapatinib. This study will be conducted in two parts. Part 1 of the study will investigate~     the impact of lapatinib on the bioavailability of oral topotecan (bioavailability phase) and~     Part 2 of the study will consist of dose finding to determine the maximum-tolerated dose~     (MTD) regimen of the combination (dose escalation phase). In Part 2 of the study, the dose of~     oral topotecan will be escalated while lapatinib will be given initially as fixed doses. The~     primary objective of the study is to determine the MTD regimen of oral topotecan administered~     for five-consecutive days every 21 days in combination with daily lapatinib in subjects with~     advanced solid tumors.~   "
219772|NCT00682266|"~     The aim of the present study was to determine the effects of a multidisciplinary approach and~     intensity-controlled interval training on cardiovascular risk factors in overweight~     adolescents~   "
219773|NCT00682253|"~     A new imaging modality combining CT and tomographic bone scintigraphy (SPECT/CT) has enabled~     the combination of functional and anatomical imaging. Its use in cancer patients has not yet~     been evaluated or validated against a relative gold stand or clinical follow up. The purposes~     of this study are: 1: to validate the use of conventional planar bone scintigraphy and SPECT~     combined with low-dose or diagnostic CT and compare this to 3 Tesla MRI and clinical follow~     up. 2: to compare the specificity of low-dose and diagnostic CT, respectively, combined with~     bone SPECT. 3: to construct an algorithm for optimal evaluation of disease dissemination in~     breast cancer patients~   "
219774|NCT00682240|"~     Imaging of retinal morphological changes with time secondary to laser treatment as assessed~     with high definition optical coherence tomography (OCT). Furthermore changes in retinal~     function as an effect of treatment will be documented by visual acuity testing using ETDRS~     charts and microperimetry. The change in vascular leakage will be assessed by performing~     fluorescein angiography, flare counts will be performed monthly.~   "
219775|NCT00682227|"~     The purpose of this study is to evaluate the safety and immunological monitoring for peptide~     vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or~     metastatic esophageal squamous cell carcinoma~   "
219776|NCT00682214|"~     Hypovitaminosis D is common in Asian Indians despite plenty of sunshine and relates to their~     skin pigmentation and poor sunshine exposure. Serum 25(OH)D levels are <20 ng /ml in up to~     90% of them and therefore, based on the modern cut off, majority of apparently healthy normal~     Asian Indians would be classified as vitamin D deficient. Though, several investigators have~     highlighted the paradox of hypovitaminosis D in sunny Indian environment, there are only~     limited studies which have assessed its functional significance. To date, the significance of~     low serum 25(OH)D in them have been analyzed in terms of its inverse relationship with serum~     parathyroid hormone levels and variable association with reduced bone mineral content at hip~     and spine on DXA. Recently we have shown impairment in the absorption of intestinal calcium~     in 25(OH)D and its reversal after eight weeks of cholecalciferol supplementation. Present~     study is being taken to further understand the functional significance of 25(OH)D in terms of~     its effect on Skeletal muscle strength including its energy metabolism, bone mineral~     homeostasis and Th1/Th2 cytokines expression in Asian Indians with chronic biochemical~     hypovitaminosis D~   "
219777|NCT00682201|"~     Prospective, observational study of the changes in hemodynamic variables such as blood~     pressure, cardiac output, systemic vascular resistance, and of changes in respiratory~     variables such as vital capacity, and functional residual volume.A cohort study of 100~     healthy pregnant women tested with non-invasive methods during pregnancy and 6 months after~     delivery.~   "
219778|NCT00682188|"~     Overweight in adolescents has nearly tripled in the past two decades and has serious physical~     and psychosocial consequences, both during adolescence and into adulthood. School nurses have~     tremendous potential to prevent and treat overweight in this population, as over 95% of~     adolescents have contact with the school health system each year and school nurses have the~     credibility and skills to provide guidance regarding weight, diet and physical activity. The~     goals of the proposed exploratory study are to adapt an innovative, theory-based school~     nurse-delivered counseling intervention model used effectively for smoking cessation for the~     treatment of adolescent overweight, and test its feasibility and potential efficacy in~     reducing BMI, improving diet, increasing physical activity and decreasing sedentary behavior.~     If the results of this exploratory study prove promising, the efficacy of the intervention~     will be evaluated in a large scale randomized controlled trial.~   "
219781|NCT00682149|"~     There has been an increase in the prevalance of type 2 diabetes in developed countries in~     recent years. The major contributing factors have been genetic predisposition, environmental~     factors, and unhealthy eating habits and stress. Adverse effects on cardiovascular and renal~     systems after prolonged hyperglycemia bring serious burden to patients, to their families and~     to the society.~      Oxidative stress has been defined as the imbalance between the production of reactive oxygen~     molecules and antioxidant protective molecules. It has been claimed that oxidative stress~     that the organism is exposed to and disturbance in anti-oxidant mechanisms have been~     important in the initiation of diabetes and its complications. Malondialdehyde is the final~     product of lipid peroxidation and it is an aldehyde as well. It has been accepted that~     malondialdehyde has been a biomarker in measuring oxidative stress.~      Type 2 diabetic people who are between 40 -65 years of age will be the subjects of our study.~     The levels of fasting glucose, HbA1c, LDL, triglyceride, AST and ALT and also~     malondialdehyte, hydrogen peroxide and oxidative stress will be determined in patients blood~     after making them consume a 1500 calory standard diet for 2 weeks, The patients will be~     randomly divided into two grouos at the end of the two weeks. Group 1 will take placebo in~     addition to the diet, Group 2 will receive polyphenol containing capsules with pomegranate~     extract (500 mg), green tea extract (300 mg) and a little bit of (60 mg) vitamin C for three~     months. At the end of three months the measurement of biochemical parameters will be~     repeated.~      Patients with cardiac, renal, liver disease and smokers will be excluded from the study.~      Patients in both groups will have a diet rich in vegetables, three servings of fruit, maximum~     three slices of bread with a total calory of 1500.~      In addition to these, both groups will have a weekly aerobic exercise regimen of 150 minutes~     conducted after breakfast.~      The biochemical results of the two groups will be compared at the end of the experiment and~     they will be statistically evaluated.~   "
219782|NCT00682136|"~     The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus~     abdominis plane) blocks in providing pain relief in the first 24hrs following open or~     laparoscopic elective abdominal colorectal operations.~      TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus~     abdominis plane in the abdominal wall. This injection takes place after induction of~     anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a~     potential safer alternative to epidural anaesthesia. The blocks have been extensively used in~     the Hunter New England system over the last 18 months. As yet there is no clear evidence for~     there efficacy, hence the need for this trial.~      This trial would establish the efficacy of this practice. If the technique proves effective~     it could be widely used and provide a simpler method of managing post operative pain.~   "
219783|NCT00682123|"~     There is compelling evidence that some dietary supplements consumed by the general population~     are manufactured and stored under conditions that lead to contamination of the end product~     with small amounts of extraneous materials. In most cases, this is harmless, but for athletes~     liable to drug testing as a consequence of their participation in sport, the potential~     consequences of even trivial amounts of a prohibited substance may be catastrophic. Quality~     control procedures for pharmaceutical products normally specify the absence of contaminants~     at a level of more than 0.1%, ie 1mg/g. However, in the case of an anabolic steroid such as~     nandrolone, the amount that will cause a positive test has been estimated to be about 1-3µg~     (Geyer et al, 2004). In the case of a supplement that is taken in high doses (20-30 g/d),~     such as for example creatine, this means that a contamination level of something closer to~     0.00001% (ie 1µg/g) may cause a positive test. This work have been supported by recent~     findings from our laboratory (Judkins et al, 2006). These data demonstrate that as little as~     10μg of 19-noradrostenedione (19-NorAD) added to a creatine supplement resulted in a positive~     doping test in all volunteers testing. This is one thousand times less that the purity level~     specified for pharmaceutical agents and at this level, these contaminants are without any~     pharmacological action.~      Proposals are under development to regulate the sale of dietary supplements for use by~     athletes to avoid accidental doping positives as a result of ingestion of contaminated~     supplements. This requires a knowledge of the amounts of contaminant that is likely to cause~     problems. The aim of the present study was to examine the urinary excretion pattern of~     nandrolone metabolites following 1µg, 2.5µg and 5µg doses of 19-norandrostendione in both~     male and female subjects. The quantity of 19-norandrostenedione administered in this study is~     representative of the amount previously reported as an undeclared contaminant in some dietary~     supplements. Given the speculation surrounding positive doping cases being attributed to~     ingestion of sports supplements contaminated with pro-hormones, this presents an important~     consideration for both athletes and doping agencies, as well as supplement manufacturers.~   "
219784|NCT00682110|"~     The purpose of the study is to determine if the less invasive monitors are as reliable for~     measuring heart function in patients undergoing liver transplantation as the more invasive~     pulmonary artery.~   "
219785|NCT00682097|"~     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes~     mellitus. Successive cohorts of patients will be randomized to receive either active drug, at~     escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the~     target sample size is <100 individuals.~   "
219786|NCT00682084|"~     The purpose of this study is to investigate the effect og chronic elevated levels of cortisol~     on metabolism and insulin sensitivity.~   "
219787|NCT00682071|"~     Ultrasound (US) guided embryo transfer (ET) appears to improve pregnancy outcomes in IVF-ET.~     Most reports are done using a transabdominal (TAS) approach, in contrast to a transvaginal~     ultrasound (TVS) which does not require a full bladder. We sought to determine if either~     approach was better with respect to clinical outcomes.~   "
219788|NCT00682058|"~     The aim of this study is to measure important components of weight change in patients who~     underwent bariatric surgery on measures of fat mass and its distribution and fat-free mass~     (FFM) (bone mineral density, skeletal muscle, and specific organs) at 60 months (T60) and 84~     months (T84) post-surgery, and to compare compartment sizes with stable weight controls.~   "
219789|NCT00682045|"~     The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB~     assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients.~     For this purpose, the investigators enrolled renal transplant recipients and observed the~     developement of tuberculosis within 1 to 2 years after the transplantation.~   "
219790|NCT00682032|"~     The purpose of this study is to determine how beta-glucan affects the immune system in~     subjects with non-small cell lung cancer.~   "
219791|NCT00682019|"~     The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil~     therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile~     dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual~     intercourse. In addition it should have been determined, if subjects with ED from a broad~     etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours~     prior to sexual intercourse.~   "
219792|NCT00682006|"~     The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and~     meticulous hand washing by primary health care providers of newborn infants will reduce the~     incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord~     care.~   "
219818|NCT00681668|"~     The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female~     patients with postpartum depressive disorder with psychotic symptoms~   "
219902|NCT00680550|"~     To describe the clinical indications for Reveal XT in diagnosis and continuous monitoring of~     arrhythmia and to explore the clinical applications and outcome of arrhythmia monitoring on~     patient care.~   "
219793|NCT00681993|"~     Breast conserving therapy, (BCT), which consists of wide local excision of the tumor followed~     by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast~     cancer. Evidence now suggests that WBI may not be necessary and treatment to the involved~     area only, partial breast irradiation, (PBI), may suffice. PBI can be achieved by~     interstitial or intracavitary brachytherapy, intra-op, or post op external beam radiation~     therapy. The feasibility, toxicity and efficacy of PBI are currently being studied in both~     the U.S. and Europe. Review of smaller studies suggests that PBI will prove to be comparable~     to WBI. Chemotherapy combined with radiation has been shown to increase local control in BCT~     when compared to radiation alone. However there is little data on how sequencing or timing of~     these therapies with respect to one another affect outcome. As a result there is no consensus~     about the optimal combination. There are real and potential benefits to concurrent~     chemo-radiation therapy. Concurrent therapy 1) allows both treatments to start closer to~     surgery, theoretically maximizing the benefits of each modality; 2) shortens the overall~     treatment program; and 3) may also improve local control via chemo-sensitization of residual~     cancer cells. However, concurrent chemotherapy and WBI have been associated with prohibitive~     skin toxicity. Since less breast tissue is treated with PBI, this skin toxicity may no longer~     be prohibitive. We have shown in J0381 that PBI and concurrent dose dense AC is safe. As a~     follow-up, we propose a phase I/II trial addressing the toxicity and efficacy associated with~     PBI delivered concurrently with various chemotherapy regimens.~   "
219794|NCT00681980|"~     Is the valproic acid efficacy to treat TSP/HAM~   "
219795|NCT00681967|"~     To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation~     radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and~     Iressa~   "
219796|NCT00681954|"~     The purpose of the study is to determine whether transfusion is associated with mild~     pulmonary changes.~   "
219797|NCT00681941|"~     Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this~     study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this~     study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an~     effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD~     patients not on dialysis. Total length of participation is approximately 14 weeks.~   "
219798|NCT00681928|"~     RATIONALE: Gathering information about cognitive function over time in postmenopausal women~     with breast cancer may help doctors learn about the long-term effects of aromatase inhibitor~     therapy and plan the best treatment.~      PURPOSE: This clinical trial is studying cognitive function in older postmenopausal women~     with stage I, stage II, or stage III breast cancer receiving hormone therapy and in healthy~     volunteers.~   "
219799|NCT00681915|"~     This is a study to evaluate safety, tolerability, PK and PD effects of orally administered~     AZD7325 after single and repeated ascending doses.~   "
219800|NCT00681902|"~     The purpose of this study is to explore to what degree, if any, Jet lidocaine will reduce or~     alleviate pain, as compared to Jet normal saline, in children undergoing needle insertion in~     the Pediatric Emergency Department (PED). If effective, Jet lidocaine would afford a novel~     rapidly acting local anesthesic for children in the PED.~   "
219801|NCT00681889|"~     The purpose of this study is to determine the effectiveness and safety of ranibizumab~     (Lucentis) in treatment of corneal neovascularization.~   "
219802|NCT00681876|"~     This phase II study will evaluate the efficacy of the combination of two monoclonal~     antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed~     after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.~   "
219803|NCT00681863|"~     The primary objective of this open-label, flexible dose study is to assess the safety and~     efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years~     inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of~     Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641~     (NCT 00681863) or 248.644 (NCT 00558467).~   "
219804|NCT00681850|"~     Demonstrate that the use of benchmarking improves quality of patient care, in particular the~     control of diabetes, lipids and blood pressure, by determining the percentage of patients in~     the benchmarking group achieving pre-set targets for HbA1c 14,18, LDL-cholesterol16,18 and~     Systolic Blood Pressure17,18 versus control group (non-benchmarking group) after 12 months of~     follow-up.~   "
219805|NCT00681837|"~     The purpose of this study is to assess prevalence of gastrooesophageal reflux during~     childhood and teenage years in France and to describe patients'symptoms and gastrooesophageal~     reflux management~   "
219806|NCT00681824|"~     The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a~     double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa~     surgery as an adjunct to dura and dura substitute sutures in preventing postoperative~     cerebrospinal fluid (CSF) leakage.~   "
219807|NCT00681811|"~     This is a multi-center, open-label, extension study of patients with late infantile MLD who~     have previously completed clinical study HGT-MLD-048 (NCT00633139), defined as the completion~     of all Week 52 procedures. This group of patients will be offered ongoing treatment with~     HGT-1111 in this protocol. One infusion will be given every other week until the product is~     commercially available, the patient discontinues, or the study is terminated by the Sponsor,~     provided no safety issues have emerged.~   "
219808|NCT00681798|"~     The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended~     dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine~   "
219809|NCT00681785|"~     The rationale for thrombophrophylaxis is well known. Without prophylaxis the incidence of~     objectivlely confirmed, hospital-acquired deep venous thrombosis is approximately 10% to 40%~     among medical or general surgical patients. In urology the prevalence is 15-40%. The Seventh~     ACCP Conference on Antithrombotic and Thrombolytic Therapy1 recommend against specific~     prophylaxis in patients undergoing transurethral procedures. Our study is the first~     double-blind, placebo-controlled study with Dalteparine as thrombophrophylaxis in~     transurethral surgery. The aim of the study is to proof that thrombophrophylaxis causes not~     more complications in transurethral surgery than without.~   "
220392|NCT00674076|"~     We hypothesize the width air-colum of retropalatal region and tongue voulme by ultrsound~     through submental area is different between normal control with those with obstructive sleep~     apnea syndrome who was comfirmed by polysomography.~   "
219820|NCT00681642|"~     Human serum eye drops have been successfully used in the treatment of severe ocular surface~     disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven~     to be effective in treatment of dry eye and persistent corneal epithelial defects. However,~     there are limited studies comparing the corneal epithelial wound healing promoting effects~     between these two blood derived products. The purpose of this study is to test the corneal~     epithelial wound healing promoting effects between auto serum and human cord blood serum.~     Primary cultured bovine corneal epithelial cells were used as the model to investigate wound~     healing, cell proliferation and migration by means of scratch corneal wound healing assay~     evaluation, MTS assay and Boyden chamber migration assay in response to human serum and~     umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared~     between human serum and umbilical cord serum with ELISA kits.~   "
219821|NCT00681629|"~     The purpose of the study is to investigate the well-being of schizophrenic patients treated~     with quetiapine XR combined with participation in the integrated care program compared to a~     treatment with quetiapine XR alone over a period of 18 month~   "
219822|NCT00681616|"~     An investigation of a new catheter and pressure monitor system that may help to prevent a~     complication called compartment syndrome from developing in an injured leg. Compartment~     syndrome occurs when too much fluid builds up in the muscles of the injured leg. This causes~     a lot of swelling and increases pressures within the leg that can cause permanent damage~     muscles and nerves in the leg.~   "
219823|NCT00681603|"~     1. Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of~          bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this~          human interventional study is to report the treatment outcome of subconjunctival~          injection of bevacizumab in patients with corneal neovascularization.~        2. Material and methods: We enrolled 13 patients with unilateral or bilateral clinically~          significant corneal neovascularization during Aug. 2007 to Jan. 2008. Subconjunctival~          injection of bevacizumab once per month for at most 7 times was performed according to~          clinical response.~        3. Main outcome measurements: resolution of corneal neovascularization, reduction of lipid~          infiltrate, improved visual acuity.~   "
219824|NCT00681590|"~     This study will evaluate the safety over 6 months of two different doses of vitamin D~     (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation~     with vitamin D improves physical performance.~   "
219825|NCT00681577|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402~     restricted epitope peptides URLC10, KOC1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.~   "
219826|NCT00681564|"~     The purpose of this study is to determine the effect of periodontal therapy on endothelial~     function and other biomarkers of cardiovascular disease~   "
219827|NCT00681551|"~     To verify the number of metastatic brain tumors detected in contrast-enhanced MRI, which is~     the primary variable, increases after an additional dose of Magnevist (SH L 451A) comparing~     images after an initial dose (0.1 mmol/kg) with those after an additional dose (0.1 mmol/kg,~     a total dose of 0.2 mmol/kg) intra-individually in patients with metastatic brain tumors.~     Safety was also to be assessed.~   "
219828|NCT00681538|"~     The purpose of this study is to determine whether Sativex® versus Placebo is effective in the~     relief of symptoms of spasticity in subjects with multiple sclerosis, who have been~     identified as having a capacity to respond to Sativex.~   "
219829|NCT00681525|"~     The objective of this study is to evaluate the potential PK interaction between ABT-335,~     atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.~   "
219830|NCT00681512|"~     The purpose of this study is to determine how berries affect cancer tumors in patients with~     non-small cell lung cancer.~   "
219831|NCT00681499|"~     Patients with malignant diseases are increasingly receiving more extensive hepatic~     resections, with im-proved preoperative and postoperative care leading to a reduced~     postoperative morbidity and mortality. In this setting, postoperative quality of life may~     become as important as overall patient survival. In this study we will be investigating the~     effect of the initial disease for which hepatic resection was carried out on short- and~     long-term quality of life.~   "
219832|NCT00681486|"~     The study is designed to evaluate whether ghrelin treatment can improve appetite in weight~     losing cancer patients.~   "
219833|NCT00681473|"~     In this research study, we are looking to study the side effects from the use of proton~     radiation in treating people with low-grade gliomas that are recommended radiation treatment.~     We expect response of the tumors to be the same with proton radiation as compared to standard~     3D conformal radiation therapy, but also expect less side effects from radiation.~   "
219834|NCT00681460|"~     Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels~     (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of~     increased maternal body's resistance to insulin - a major hormone that allows for utilisation~     of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more~     frequently in overweight women but also in women with a history of certain conditions such as~     polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it~     is associated with some serious hazards for women and her unborn child, if untreated~     properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if~     keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin~     therapy is effective but it requires several injections during each day and insulin is a~     strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous~     for mother and unborn child.~      In the investigators study, the investigators would like to investigate if metformin that is~     a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has~     been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and,~     according to current data, it is not dangerous neither for mother nor for baby when used~     during gestation.~   "
219835|NCT00681447|"~     1. To demonstrate clinically significant improvements in patients undergoing lumbar~          interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome~          measures of pain and function.~        2. To evaluate and compare the adverse event profile in all patients.~   "
220393|NCT00674063|"~     Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg~     with moderate to severe Chronic Plaque Psoriasis~   "
219836|NCT00681434|"~     This randomized, single-blind study compares the effectiveness of bilateral training to~     unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral~     training will be superior to unilateral in the proximal extremity but not the distal one.~   "
219837|NCT00681421|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201~     restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.~   "
219838|NCT00681408|"~     Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20%~     chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and~     insulin resistance. Therapy usually includes recommendations to increase exercise and to~     begin weight reducing diets but these goals are variably achieved and their relative effects~     in conjunction with pharmacological intervention have not been well defined. Moreover, these~     lifestyle changes can confound results of treatment trials if not quantified through~     conditioning testing and measures of body fat. Polyunsaturated fatty acids, especially~     formulation rich in omega-3, are widely accepted and endorsed in the medical community for~     their beneficial effects on hyperlipidemia and coronary disease risk reduction. Recent data~     suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models~     of NASH by reducing hepatic fat content. We hypothesize that a one year course of omega-3~     fatty acid (3gm/day) will produce improvement in NASH histological injury independent of~     changes in weight (BMI) or degree of conditioning measured by the lactate threshold. The~     effects of the supplement will be compared to a placebo group and controlled for these~     lifestyle changes.~   "
219839|NCT00681395|"~     To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination~     ABT-143 relative to that from the co-administration of the two monotherapies.~   "
219840|NCT00681382|"~     This study was aimed at clarifying how the asthma medication is used in practice and how~     asthma affects everyday life. Total of 106 GPs were asked to recruit patients using inhaled~     steroid as maintenance treatment for asthma to take part in a telephone survey. Altogether~     142 patients were interviewed.~   "
219841|NCT00681369|"~     the purpose of this study is to describe the way Faslodex is used in France, in patients~     suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to~     determine patients profile~   "
219842|NCT00681356|"~     Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients~     undergoing total knee replacement~   "
219843|NCT00681343|"~     To observe in a randomized prospective pilot study the effectiveness and toxicity of~     Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD)~     kidneys, compared with our standard treatment protocol of Zenapax® and maintenance~     immunosuppression~   "
219844|NCT00681330|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402~     restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.~   "
219845|NCT00681317|"~     This is a study to evaluate safety, tolerability, PK and PD effects of orally administered~     AZD6280 after single and repeated ascending doses.~   "
219846|NCT00681304|"~     This is a pilot study. The main purposes for doing the study are to see if there is a~     relationship between lumpectomy volume and position as measured by USEI and by CT. This is~     not a study to see if the use of USEI is better than the current method of using CT for daily~     radiation therapy positioning.~   "
219847|NCT00681291|"~     This is a prospective, randomized, controlled, third-party blinded, multicenter,~     interventional evaluation of inguinal hernia repair comparing Strattice to light weight~     polypropylene mesh. Performance and outcomes measures to be compared include postoperative~     resumption of activities of daily living, nature and incidence of short- and long-term pain~     and complications, and incidence of hernia recurrence.~   "
219848|NCT00681278|"~     This study will address the treatment rate and control rate of hypertension, treatment~     pattern and factors to affect blood pressure control by examining (retrospective) medical~     records of hypertension patients having Type 2 Diabetes mellitus, among outpatients coming to~     the Endocrinology Department in 20 general hospital settings nationwide.~   "
219849|NCT00681265|"~     This study is an exploratory trial evaluating the tear film break-up time after a single eye~     drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear~     film break up time will be greater for test than control eye.~   "
219850|NCT00681252|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201~     restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.~   "
219851|NCT00681239|"~     The modified Atkins diet (MAD) is a relatively new, alternative dietary therapy for~     intractable childhood and adult epilepsy. Recent evidence suggests that a strict, highly~     ketotic, first month may be advantageous to both immediate and long-term efficacy. KetoCal®~     is a pre-mixed powder that can be used to create a 4:1 ketogenic diet shake as a meal~     substitute. The investigators hypothesize that substituting KetoCal® for a lunch during the~     initial month of the MAD will lead to improved seizure reduction over the MAD alone, as well~     as improved tolerability and lipid values.~   "
219852|NCT00681226|"~     Leg pain caused by peripheral arterial disease (PAD) can severely impede walking ability. Our~     preliminary findings indicate that the drug ramipril is much more effective in improving~     walking ability than current therapies. To be accepted as a new treatment for PAD these~     findings require validation in a much larger clinical trial.We propose to examine the effects~     of ramipril therapy for 6 months in a randomized, controlled trial of patients with PAD. If~     positive, this study will identify ramipril as a potential new therapy for PAD.~   "
219853|NCT00681213|"~     Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs.~     SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants.~   "
219854|NCT00681200|"~     High blood pressure is a common health problem among people in the United States. This study~     will compare the effectiveness of a meditation program versus a health education program at~     decreasing stress and lowering blood pressure levels among African-American adults with high~     blood pressure.~   "
219903|NCT00680537|"~     This is a clinical research study to determine if a prescribed physical therapy intervention~     after subcutaneous implantation of an implanted cardioverter-defibrillator (ICD) or pacemaker~     reduces the incidence of rotator cuff tendonitis when compared to usual post procedural care.~   "
219855|NCT00681187|"~     The primary aim of this study is to assess which method of lanreotide Autogel administration~     patients with neuroendocrine tumours prefer - self/partner administrations or healthcare~     provided administrations. The study will also assess if self/partner administration can be~     performed without loss of efficacy and with a preserved safety profile. The impact of~     self/partner administration on resource utilisation and costs will be studied. In addition,~     we will also assess the healthcare provider's experience of the two administration practices.~   "
219856|NCT00681174|"~     The main hypothesis of this study is that preoperative administration of controlled-release~     (CR) oxycodone may reduce acute postoperative pain and improve time to discharge from the~     post-anesthesia care unit in patients undergoing video-assisted thoracoscopy for spontaneous~     pneumothorax.~      The study drug will be compared with intravenous morphine administered 30 minutes before the~     end of anesthesia.~   "
219857|NCT00681161|"~     The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic~     dysfunction independent of its effects on hyperglycemia.~   "
219858|NCT00681148|"~     The purpose of this study is to see if botox injection into the prostate during seed~     implantation (brachytherapy) for prostate cancer a) improves urinary symptoms or avoids need~     for urinary tract instrumentation over the 6-8 month post-operative period when one wants to~     avoid manipulating the radioactive seeds, and b) speeds up the drop in PSA. Patients will be~     randomized to botox vs saline injection, at the completion of the seed implantation~     procedure.~   "
219859|NCT00681135|"~     The purpose of this study is to determine whether the use of a sonic toothbrush alone is more~     effective than two other toothbrushing protocols on dental plaque elimination in patients~     with fixed orthodontic appliances.~   "
219860|NCT00681122|"~     This observational study is restricted to postmenopausal women with hormone-sensitive early~     breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or~     letrozole, according to the current product SmPCs. There is no Investigational Medicinal~     Product (IMP) to be taken in this observational study. The adjuvant AI medication must not~     have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In~     Daily practicE through Educational approach), impact of educational material on women's~     compliance and persistence rates will be evaluated.~   "
219861|NCT00681109|"~     The purpose of this study is to determine the effectiveness and safety of Topical~     Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior~     blepharitis.~   "
219862|NCT00681096|"~     An examination of the various factors that cause lower back pain in nurses in four hospitals~     in Israel such as; socio-demographic, professional, posture while ambulating patients and job~     environment.~   "
219863|NCT00681083|"~     Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway~     Pressure (CPAP)when titrated with different levels of humidification. It is hypothesised that~     patients with ThermoSmart® technology (heated breathing tube technology) will have lower~     titrated pressures than those who are titrated using conventional humidification (non heated~     breathing tube).~   "
219864|NCT00681070|"~     Our research hypothesis in this study is that there is no difference in long-term cosmetic~     outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric~     facial lacerations.~   "
219865|NCT00681044|"~     RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells~     by stopping them from dividing or killing them. Giving colony-stimulating factors, such as~     G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the~     blood so they can be collected and stored. Chemotherapy is then given to prepare the bone~     marrow for the stem cell transplant. The stem cells are then returned to the patient to~     replace the blood-forming cells that were destroyed by the chemotherapy.~      PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given~     together with stem cell transplant and to see how well it works in treating patients with~     immunoglobulin deposition disease or light-chain deposition disease.~   "
219866|NCT00681031|"~     Primary objective:~      To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry~     potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by~     glycoprotein Enzyme Linked ImmunoSorbent Assay [gpELISA]) from pre-vaccination to 4 weeks~     post-vaccination.~      Secondary objectives:~      To describe the safety profile of ZOSTAVAX® at minimum release specification approaching~     expiry potency.~   "
219867|NCT00681018|"~     To evaluate weight gain of preterm infants fed fortified human milk.~   "
219868|NCT00681005|"~     Backgrounds & Aims: Proton-pump inhibitor (PPI) test has been proposed as a valuable tool in~     the diagnosis of gastroesophageal reflux disease (GERD) in Western populations. We assumed~     that a higher prevalence of poor metabolizers in Chinese population might affect the~     diagnostic accuracy of a PPI test.~      Methods: In this open-label, randomized trial, patients with symptoms suggestive of GERD were~     randomly assigned to receive a 2-week test with daily rabeprazole 40-mg or daily pantoprazole~     80-mg after diagnostic endoscopy. Therapeutic response was assessed with a five-grade daily~     record. Genotypes of cytochrome P450 (CYP) 2C19 polymorphism were determined.~   "
219869|NCT00680992|"~     To determine how safe denosumab is in treating subjects with giant cell tumor of bone~   "
219904|NCT00680524|"~     Objective: OEF/OIF (Operation Enduring Freedom and Operation Iraqi Freedom) veterans are~     presenting with high rates of PTSD. Translating Initiatives for Depression into Effective~     Solutions (TIDES) is a model of phone-based care being implemented nationally as a model to~     address those patients suffering from depression, PTSD, or alcohol use disorders. However,~     evidence-based treatments do not yet exist for phone-based management of OEF/OIF veterans who~     suffer from PTSD.~      Research Plan:~      This is an open trial to assess feasibility of augmenting standard treatment of PTSD with~     TIDES based telephone-based nurse care management.~   "
219941|NCT00680030|"~     In the current study we plan to evaluate the effects of the conversion from gastric banding~     to gastric bypass on esophageal function using combined monitoring. The primary aim of the~     current study is to evaluate esophageal function before and 3-months after the conversion~     from gastric banding to gastric bypass. A second objective is to evaluate the severity of~     symptoms, esophageal dysmotilities, endoscopic abnormalities and bolus retention found in~     patients referred for conversion from gastric banding to gastric bypass. Our hypothesis is~     that esophageal motility disorders associated with gastric banding are reversed by conversion~     to gastric bypass.~   "
219870|NCT00680979|"~     This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive~     weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health~     education program in preventing weight gain.~      Adolescent girls between 12 and 17 years of age who are at risk for becoming overweight~     adults, by virtue of being above average weight and experiencing episodes of loss of control~     over eating, may be eligible for this study. Candidates are screened in two visits with the~     following procedures:~      Visit 1~        -  Height and weight measurements.~        -  Interview and questionnaires about the child s general health, social and psychological~          functioning and eating patterns and behaviors.~      Visit 2~        -  Physical examination, blood and urine tests.~        -  DXA scan to measure body fat, muscle and bone mineral content.~        -  Laboratory test meal. The child fills out a rating scale about her level of hunger and~          is then given a food buffet from which she is instructed to eat as much as she wants.~          Immediately after eating, the child again completes the hunger rating forms.~        -  Interview about the child s mood and psychological functioning.~      Participants are assigned at random to either the IPT or teen health education program. All~     participants have a 1- to 1 1/2-hour individual session with a therapist, followed by 12~     weekly group sessions of 1 1/2 hours each in their assigned program. They are assessed at the~     end of the program with questionnaires and body measurements. They return to the clinic after~     6 months for body measurements, blood test, DXA scan, questionnaires, interview and a test~     meal, and again at 1 year for body measurements, questionnaires and a DXA scan.~   "
219871|NCT00680966|"~     The purpose of this study is to determine whether it is more effective to treat adolescents,~     with diagnoses of both depression and substance use disorder, with a treatment addressing the~     substance use first and then treating the depression or to first treat the depression and~     then treat the substance use or whether treating both disorders simultaneously is most~     effective.~      It is expected that treatment of both disorders at the same time will be the most effective.~   "
219872|NCT00680953|"~     Evaluate the efficacy and safety of denosumab in the treatment of involutional~     (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral~     fracture(s)~   "
219873|NCT00680940|"~     The purpose of this study is to determine whether Mycobacterium w in combination with~     Paclitaxel plus Cisplatin are effective in Advanced Non Small Cell Lung cancer.~   "
219874|NCT00680927|"~     The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics~     of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave~     sensing performance, to obtain user feedback, from both patient and physician, and collect~     data on device safety.~   "
219875|NCT00680914|"~     The purposes of this study are:~      To demonstrate the immunogenicity in terms of antibody response following primary vaccination~     of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™~     when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during~     the first 6 months of life.~      To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and~     serious adverse events following primary vaccination of Korean infants with the pneumococcal~     conjugate vaccine GSK 1024850A.~   "
219876|NCT00680901|"~     This is an international multi-center trial that will enroll patients with locally advanced,~     unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose~     tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether~     lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx),~     extends the time to progression and overall survival. Tumor ErbB2 (HER2) status must be known~     before trial entry. CapeOx is administered to all patients, and patients will be randomly~     assigned to receive either lapatinib or placebo.~   "
219877|NCT00680888|"~     Observational study aimed to describe the adherence in a population of adolescents and~     children treated on quetiapine from a first psychotic episode whose more important secondary~     objective is to identify possible predictive factors influencing the adherence to treatment~     with Quetiapine~   "
219878|NCT00680875|"~     The purpose of this research is to create an effective, disseminable, and exciting~     computer-based tobacco prevention program for 5th and 6th grade students. The goal of this~     school-based program is to decrease children's behavioral intentions and willingness to use~     tobacco, and to prevent or delay their initiation of tobacco use.~      We will augment the 5th grade program with a booster program in 6th grade, and evaluate the~     long-term efficacy of the entire tobacco prevention program by conducting a randomized~     controlled trial in elementary and middle schools.~   "
219879|NCT00680862|"~     Qualitative assessment of implementing routine HIV rapid testing in primary care clinics~     within VA~   "
219880|NCT00680849|"~     This study is a 5-year continuation of The Mediterranean Lifestyle Program. The purpose of~     this follow-up study is to determine the long-term effects from prior participation in an~     intervention promoting healthful eating, exercise, quitting smoking, stress management, and~     social support. Participants are post-menopausal women with type 2 diabetes.~   "
219881|NCT00680836|"~     The purposes of this study are to estimate the burden of disease due to chronic~     gastrointestinal illness in PG veterans, to evaluate whether Small Bowel Bacterial Overgrowth~     (SBBO) is associated with chronic diarrhea in PG veterans, and to determine whether~     eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG~     veterans.~   "
219882|NCT00680823|"~     Objective: To determine if lower paracervical intramuscular ropivacaine injection is an~     effective treatment for pediatric headache in an emergency department setting.~   "
219914|NCT00680394|"~     A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and~     acceptability of two medical abortion regimens up to 63 days' LMP. The first regimen will~     include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second~     regimen will include two 800 mcg doses of buccal misoprostol. We hypthesize that both methods~     work well, but that the mifepristone regimen will have an efficacy rate of approximately 95%,~     and misoprostol alone will be closer to 90%. We will consider a greater than 5% difference to~     be clinically meaningful.~   "
219942|NCT00680017|"~     The objective of this study is to evaluate the safety and efficacy of the combination of~     ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.~   "
219883|NCT00680797|"~     The goal of this research study is to study the effect of testosterone or estrogen on blood~     sugar control and fat metabolism. Changes in hormone levels with age may affect risk factors~     for heart disease such as diabetes. Diabetes is a glandular condition associated with lack of~     the hormone insulin or an insensitivity to it resulting in problems with blood sugar control~     and fat metabolism. The effect of commonly used hormonal supplements such as testosterone by~     older adults on insulin and body composition is not well understood. In this study, the role~     of testosterone and estrogen on your ability to control blood sugar and your body composition~     will be assessed.~      The investigators plan to study 60 subjects. All of these subjects will be healthy older men~     between the ages of 60-85 years old who are not on testosterone therapy. Subjects that are~     screened who have any clinically significant abnormalities detected on their screening~     physical exam or laboratory testing (e.g. Prostate Specific Antigen > 4), who have a history~     of prostate cancer, polycythemia, or who cannot take testosterone will not be included.~      If a subject is eligible to participate after initial screening, that subject will take~     medications to adjust their hormone levels and have tests performed that measure insulin~     sensitivity and adiposity before and after these hormone medications. The outcomes that will~     be measured are: 1) insulin sensitivity, 2) hormone levels (total and free testosterone~     levels, sex hormone-binding globulin levels) and 3) body composition and abdominal adiposity.~   "
219884|NCT00680784|"~     The objective of this study is to demonstrate the multiple-dose efficacy and safety of~     HKT-500 for the treatment of ankle sprain.~   "
219885|NCT00680771|"~     Chronic insomnia affects approximately 8-9% of the population. The prevalence of this~     disorder rises dramatically across the lifespan, especially so in women. When it is chronic,~     insomnia is associated with increased fatigue, cognitive impairment, mood disturbance,~     physical complaints, diminished quality of life and increased health care consumption. There~     is also more limited evidence (based on epidemiologic studies or experimental studies in~     healthy subjects) that insomnia and/or sleep loss may be a risk factor for hypertension~     and/or cardiovascular disease and increased mortality.~      Despite its prevalence and consequences, the pathophysiology of insomnia and, specifically,~     the pathway by which morbidity risk is conferred, has been relatively unstudied. With respect~     to medical illness in particular, insomnia may confer risk in several ways, including: 1) an~     inherent compromise in the restorative/conservative function of sleep, 2) the deleterious~     effects of hyperarousal and/or HPA axis abnormalities on end organ integrity and function,~     and/or 3) diminished immunocompetence. This study focuses on the last of these possibilities,~     the relationship between immune function and sleep.~      The study compares immune response to a vaccine challenge in two groups: good sleepers and~     patients with chronic insomnia. The primary study hypothesis is that the insomnia group will~     have a decreased rate of adaptive immune response to the vaccine challenge than that of the~     good sleeper group.~   "
219886|NCT00680758|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving more than one drug (combination chemotherapy) together with~     everolimus may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin,~     paclitaxel, and everolimus when given together for the treatment of patients with metastatic~     breast cancer.~   "
219887|NCT00680745|"~     This study is being carried out to see if dapagliflozin in addition to glimepiride~     (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared~     to glimepiride alone.~   "
219888|NCT00680732|"~     Our objective was to investigate the importance of malaria infection/disease during pregnancy~     and more particularly during the first trimester; we also looked at the maternal-foetal~     interactions and their influence on the subsequent child's response to malaria infections~     during the first year of life. This study was carried out !in the same population recruited~     for the IUGR study (NCT00642408).~   "
219889|NCT00680719|"~     This project involves two studies focusing on the engagement and treatment of adolescents~     diagnosed with substance use disorders. Study 1 will evaluate a promising parent-based~     engagement intervention, Community Reinforcement Training, designed to facilitate the entry~     of resistant drug-abusing adolescents in treatment. The approach will be compared with an~     Engagement As Usual intervention condition. Study 2 involves a controlled clinical trial~     evaluating the efficacy of an HIV/AIDS prevention intervention embedded in family-based drug~     abuse treatment for reducing HIV/AIDS risk behaviors and substance use. Adolescents who are~     successfully engaged in treatment through Study 1 will be randomly assigned to receive either~     family therapy alone or family therapy with the integrated HIV/AIDS prevention intervention.~     Both studies are being conducted in Portland, Oregon.~   "
219890|NCT00680706|"~     Heart failure remains an increasing cause of morbidity and mortality in the United States~     even in the face of recent advances in the treatment of cardiovascular disease. There is an~     urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used~     in energy metabolism from fatty acids to glucose is beneficial to the heart presumably by~     increasing the efficiency of ATP production. Several new drugs for the treatment of cardiac~     ischemia work by this mechanism. There is increasing evidence that patients with heart~     failure may also benefit by the same type of intervention. Patients with heart failure are~     known to have low serum thiamine levels because of poor dietary intake and increased urinary~     excretion. Inadequate thiamine will deleteriously shift substrate utilization from glucose to~     fatty acids.~      We hypothesize that thiamine supplementation will be beneficial for patients with heart~     failure by increasing glucose and decreasing fatty acid utilization. This will be initially~     tested in a pilot double-blinded placebo controlled study of thiamine supplementation in~     diabetic and non-diabetic patients presenting to the emergency department with acute~     decompensated heart failure.~   "
219943|NCT00680004|"~     This pilot study aims to quantitatively characterize the stresses and forces on an implanted~     endograft during the cardiac cycle in patients scheduled for standard endograft follow-up.~     The developed techniques will be applied in future studies for characterizing and comparing~     the currently commercially available endografts so as to gain insight into the mechanisms~     underlying potential endograft failure. In addition, to assist in developing endografts with~     long-term durability and functioning characteristics for the benefit of the patient~   "
219891|NCT00680693|"~     Irritable bowel syndrome (IBS) is a common and disabling functional disorder characterized by~     significant abdominal discomfort and disturbed defecation. It affects over 10% of U.S. adults~     (14% women, 8% men), resulting in major disability, impaired quality of life, and a~     significant health-care burden. Conventional management of IBS is only partially effective in~     some patients and includes use of medications, behavioral modification, dietary approaches,~     and lifestyle changes such as exercise and stress reduction. Although behavioral treatments~     such as cognitive behavioral therapy and hypnosis have been among the most effective~     treatments, they are costly to deliver.~      Mindfulness meditation, a complementary/alternative medicine (CAM) therapy taught in groups,~     is a unique self-regulatory, mind-body approach in which practitioners learn to attend to~     present-moment experiences, letting go of fixation on negative emotions and thoughts of past~     and future. It has been found to be effective in reducing chronic pain and stress and in~     ameliorating disorders with similarities to IBS, including fibromyalgia, headache, and~     depression.~      The overall goals of this exploratory, pilot study of women with IBS are to compare~     mindfulness meditation training to a patient support group (a previously validated control~     condition) in a small, randomized controlled clinical trial, in order to assess the~     feasibility of a larger, definitive trial. Specific aims are to evaluate primary and~     secondary outcome measures, to assess expectancy of benefit and scales measuring mindfulness~     (process measures), and to identify barriers to conducting such a trial in our setting. Sixty~     women meeting Rome II diagnostic criteria for IBS will be randomly assigned to one of two~     treatments - mindfulness meditation training or a support group - and will undergo 8 weekly~     group sessions plus a single day-long session. The primary outcome measure is improvement on~     the validated Irritable Bowel Symptom Severity Scale from pretreatment to the end of~     treatment, with follow-up at 3, 6, and 12 months. Additional variables address alternative~     endpoints (e.g., Adequate Relief of IBS symptoms, disease specific quality of life) and~     mechanism of treatment effects (e.g., coping scales, psychological symptoms, Visceral~     Sensitivity Scale). The multidisciplinary research team includes physicians, psychologists,~     and educators.~   "
219892|NCT00680680|"~     To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will~     alleviate urinary retention secondary to BPH in who have failed a voiding trial without a~     catheter. Following treatment with an Alpha Blocker alone.~   "
219893|NCT00680667|"~     RATIONALE: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may~     be an effective treatment for breast cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of coriolus versicolor~     extract in treating women with stage I, stage II, or stage III breast cancer who have~     finished radiation therapy.~   "
219894|NCT00680654|"~     This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic~     effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of~     sildenafil 20 mg.~   "
219895|NCT00680641|"~     To determine the effects of 2 months therapy with simvastatin 40mg once per day compared to~     placebo in a double-blind placebo-controlled study of patients with COPD.~   "
219896|NCT00680628|"~     The purpose of this study is to determine if tenecteplase plus enoxaparin is safe and~     effective in the treatment of patients with severe submassive pulmonary embolism.~   "
219897|NCT00680615|"~     To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco~     cessation website to a website with more static information that is similar to websites that~     can be found through a typical Internet search.~   "
219898|NCT00680602|"~     First line treatments fo Obsessive Compulsive Disorder (OCD) are Selective Serotonin~     Recapture Inhibitors (SSRIs) and Cognitive Behaviour Therapy (CBT) including exposure with~     response prevention. The aim of the present study is to evaluate the clinical efficacy of~     GCBT and SSRIs for OCD patients. Other clinical trials have compared these treatments, but~     with OCD patients without any other psychiatric disorder. In this study patients with current~     age between 18 and 65 years, with YBOCS score of at least 16 and psychiatric comorbidities~     will be not excluded. Exclusion criteria will be: OCD secondary to brain trauma, stroke or~     malformation; current abuse of alcohol or other psychoactive substance, current presence of~     psychotic symptoms, suicidal risk, psychiatric or clinical comorbidity that might get worse~     with the medications used in the trial. So, the present study investigates the efficacy of~     these treatments for a heterogeneous OCD population, trying to identify if the usual~     treatments are efficient when applied in the public health system that treat not just~     patients with only OCD diagnosis. Patients will be randomized for GCBT and SSRI, and after~     treatment will be evaluated by researchers blind to the treatment received.~   "
219899|NCT00680589|"~     The goal of this study is to find out about the safety of injecting the gene (DNA) for mouse~     TYRP2 in patients with melanoma. DNA is a material that contains the information needed to~     produce many substances in the body. TYRP2 is a substance found in melanoma cells that helps~     to produce their black color. The DNA used in this study is the gene for mouse TYRP2.~      The gene is introduced into bacteria, which are grown in large quantities. The DNA vaccine is~     then made from bacteria that is inactive.~      We would like to see if we can immunize patients against TYRP2 by injecting mouse TYRP2 DNA.~     We will also follow the patients closely to see if there are any side effects. Mouse TYRP2~     DNA is very similar to human TYRP2 DNA. We believe, based on lab experiments, that injection~     of mouse TYRP2 DNA could result in the production of immune substances (antibodies and T~     cells) that recognize melanoma cells. Antibodies are substances produced by your immune~     system to defend your body against bacteria and viruses. T cells are a type of white blood~     cell that can also fight infections. The small differences between mouse and human TYRP2 may~     allow your immune system to make the antibodies and T cells against melanoma. There is no~     evidence yet that injection of TYRP2 DNA results in any clinical benefit in patients.~   "
219900|NCT00680576|"~     The purpose of this study is to find out more about how to provide effective further~     treatment for adolescents who have received six weeks of group therapy for substance-use~     problems and continue to use drugs. Treatments used in the study include a group therapy~     (MET/CBT), an individual therapy (CBT), and a family therapy (FFT). The study will look at~     whether abstinence or a very low level of use is a better guide for deciding whether further~     treatment is needed, how well different combinations of treatment work to reduce substance~     use, and whether it is possible to predict in advance which adolescents will respond best to~     which types of treatment. Study investigators expect that a treatment strategy using what is~     learned about these issues in the first half of the project to develop an adaptive~     treatment model will work better than a fixed treatment to reduce adolescent substance use.~   "
219901|NCT00680563|"~     This single arm study will assess the efficacy and safety of subcutaneous Mircera for the~     correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who~     are not currently treated with ESA. Eligible patients will receive monthly subcutaneous~     injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study~     treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
219905|NCT00680511|"~     The AIMS study compares a methamphetamine-specific treatment intervention to a~     treatment-as-usual Functional Family Therapy (FFT) approach for adolescents ages 15 to 19.~     Adolescents are assigned to one of two treatment conditions: (1) 16 weeks of FFT designed to~     strengthen family relationships and develop skills for helping the adolescent avoid drug use;~     or (2) 16 weeks of a combination of FFT and a methamphetamine-specific intervention involving~     group and individual therapy sessions; Families are assessed using questionnaires and~     interviews, and adolescents participate in neuropsychological testing, before, during, and~     after treatment to provide information about family functioning, the adolescent's drug use,~     the adolescent's peers, and other factors that may contribute to treatment success.~     Adolescents also provide urine specimens for drug screening at assessment visits. Through a~     partnership with Oregon Health and Science University (OHSU), adolescents will participate in~     functional magnetic resonance imaging appointments at the hospital to examine regional brain~     blood flow during tasks designed to measure impulsivity and risk-taking behaviors. As a~     treatment development grant, study investigators will study adolescents' acceptance of and~     response to the newly developed methamphetamine-specific treatment approach.~   "
219906|NCT00680498|"~     This is a one-year, randomized, single-center open-label pilot study of the safety and~     efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to~     either combination treatment, or ranibizumab monotherapy (control group).~      The combination treatment group will receive ranibizumab, followed 1 week later by~     verteporfin PDT. Additional treatments will be based on evidence of active disease~     (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed~     monthly, and repeat PDT will be allowed every 3 months.~      The control group will receive standard-of-care ranibizumab monotherapy according to the~     protocol currently followed by most retinal specialists. Ranibizumab injections will be given~     at baseline and months one and two. Additional injections will be given at each monthly visit~     at which there is evidence of active disease by visual acuity, OCT and FA criteria.~   "
219907|NCT00680485|"~     This study will evaluate the safety, tolerability and exposure of repeat escalating oral~     doses, a loading dose/maintenance dose regimen of GSK580416 and when co administered with~     ketoconazole, a PGP/CYP3A4 inhibitor.~   "
219908|NCT00680472|"~     The objective of this study is to determine the efficacy of HKT-500 in subjects with acute~     shoulder pain~   "
219909|NCT00680459|"~     Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections~      Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct~     therapy with antibiotics to treat central venous line infections~      Study Design Randomized Controlled Trial~      Study Protocol Only those patients meeting all inclusion criteria and no exclusion criteria~     will be eligible to participate in this study. Once identified, signed informed consent will~     be obtained from the patient's guardian and the patient himself/herself depending on age.~     Patients will be randomized into 2 groups: Group 1 - those patients who will receive ethanol~     lock therapy and Group 2- those patients who will receive placebo therapy in the form of a~     heparin lock solution.~      Outcome Measures Treatment success as defined by-~        -  Clearance of the infection as documented by negative blood cultures on day 6 (one day~          after completed of lock treatment)~        -  Preservation of the line at 30 days post treatment (day 35 of the study), this will be~          documented by a chart review in CIS and telephone interview to ensure no further growth~          from blood cultures or infections~      Treatment failure as defined by-~        -  Clinical worsening during treatment~        -  Removal of the line due to persistent infection or sepsis~        -  Recurrence of infection with the same pathogen within 30 days~   "
219910|NCT00680446|"~     The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in~     patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement~     therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.~   "
219911|NCT00680433|"~     Research into the mechanisms underlying memory impairment in ECT suggests that its~     development may be prevented by the administration of certain medications at the time of ECT~     treatment. For example there are reasons to believe that ketamine, also used as an~     anaesthetic agent, may have such protective properties.~      In this clinical study patients undergoing a course of ECT will be offered the opportunity to~     receive a small dose of ketamine (or a placebo) as part of their anaesthetic at the time of~     ECT treatment. Mood changes and any memory changes will be evaluated to see if the subjects~     who received ketamine had less memory side effects than those who did not, while still~     improving their depression.~   "
219912|NCT00680420|"~     Pancreas cancer and precancerous cysts can be difficult to diagnose. Sometimes biopsies do~     not show cancer when cancer is actually present. We hypothesize that genetic differences~     exist in tissue that is malignant compared to nonmalignant. When patients present with a~     pancreas mass or cyst, we biopsy it by fine-needle aspiration during upper endoscopy with~     ultrasound guidance. We would like to use tissue obtained via endoscopic ultrasound guided~     fine needle aspiration to perform DNA microarray analysis, and compare the differences in~     gene expression level in the benign tissue compared to cancerous tissue in order to improve~     our diagnostic capabilities. DNA microarray measures gene expression level rather than~     germline mutations. The true diagnosis will be based on cytology, surgical pathology, or~     clinical followup. The performance of the microarray test as a diagnostic test will be~     compared to the performance of cytology.~   "
219913|NCT00680407|"~     Silymarin, also known as milk thistle, is an alternative medicine commonly found in health~     food and vitamin stores. People with liver disease sometimes use silymarin because it is~     thought to have liver protecting effects; however, this benefit has not been proven. The~     purpose of this research study is to determine the effectiveness of silymarin and assess the~     safety of different silymarin doses in patients with varying severity of liver disease~     compared to a placebo (lactose pill).~      Following a screening visit, patients with histologically confirmed NASH will be randomized~     to either placebo or one of two active treatment groups of silymarin (Legalon®). One active~     treatment group will receive 420 mg, each dose given three times daily, the other active~     treatment group will receive 700 mg, each dose given three times daily. Patients will be~     treated for 48-50 weeks. Participation in this research study requires the patient to travel~     to the clinic for at least 11 visits so recruitment will be limited to a geographically~     restricted area around participating clinical centers. Liver biopsy must be performed up to~     12 months prior to, and immediately after, the treatment phase.~   "
219915|NCT00680381|"~     The purpose of this study is to test different treatments to reduce relapse for drug-abusing~     adolescents who have completed family therapy. Adolescents receive 12 weeks of family~     therapy, designed to strengthen family relationships and develop skills for helping the~     adolescent avoid drug use. Then they are randomly assigned to receive one of three eight-week~     follow-up treatments: phone calls from a project therapist, group therapy, or a customized~     schedule of therapist visits with the adolescent, the adolescent's family and teachers,~     coaches, probation officers and others who can help the adolescent reach or maintain~     abstinence. Families are assessed using questionnaires and interviews before, during and~     after treatment, to provide information about family functioning, the adolescent's drug use,~     the adolescent's peers and other factors that may contribute to treatment success or failure.~     Adolescents also provide urine specimens for drug screening at assessment visits. Study~     investigators expect the study will show that a functional family environment and insulating~     adolescents from the influence of peers who use drugs will help prevent relapse for~     adolescents who have received family therapy.~   "
219916|NCT00680368|"~     OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision~     Index (RSI), a survey tool for medical residents designed to measure quantitatively the level~     of supervision the resident received while caring for an outpatient during a patient care~     encounter.~      RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index~     (Index) applied to outpatient care encounters for content validity, test-retest reliability,~     and construct validity.~   "
219917|NCT00680355|"~     This investigation protocol uses an isotope reference method to evaluate bioavailability of~     ß-C in rice and its bioconversion to vitamin A.~      A well-nourished population will be fed hydroponically grown Golden Rice containing ~ 1 mg of~     β-carotene at day 8 after a reference dose of vitamin A at day 1. The blood samples will be~     collected up to 33 days after the doses. The absorption kinetics will be determined by~     tracking both vitamin A and β-carotene in human serum. Blood responses to Golden Rice~     β-carotene will be determined and evaluated. The vitamin A value of Golden Rice can thus be~     quantitatively determined.~   "
219918|NCT00680342|"~     Silymarin (Legalon), also known as milk thistle, is an alternative medicine commonly found in~     health food and vitamin stores. People with liver disease sometimes use silymarin because it~     is thought to have liver protecting effects; however, this benefit has not been proven. The~     purpose of this research study is to determine the effectiveness of silymarin and assess the~     safety of different silymarin doses in patients with varying severity of liver disease~     compared to a placebo (lactose pill).~      Eligible subjects will be randomized to treatment with placebo or one of two dosages of~     Legalon® 420 mg or 700 mg administered orally thrice daily. Investigators and subjects will~     be masked to treatment assignment. The study design includes a screening period during which~     patients will undergo full medical evaluation to verify protocol eligibility and a treatment~     period of 24 weeks during which time clinic visits and laboratory studies will be performed~     every 2-4 weeks to monitor for safety and efficacy of therapy. Subjects will continue to be~     followed for an additional 12 weeks after the completion of study medication to monitor for~     adverse events and investigate post-treatment outcomes. Participation in this research study~     requires the subject to travel to the clinic for at least 10 visits so recruitment will be~     limited to a geographically restricted area around participating clinical centers.~   "
219919|NCT00680329|"~     The purpose of this study is to evaluate adherence to DuoTrav® when reinforced by the use of~     the Travalert™ Dosing Aid.~   "
219920|NCT00680316|"~     This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed~     to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life~     (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis (CF).~     Approximately 40 patients were planned to be enrolled in this study. However, only 3 patients~     were eligible for random allocation and received treatment: 1 patient in the Pulmozyme group~     and 2 patients in the placebo group. All 3 patients completed the study assessments but did~     not have usable pulmonary function test (PFT) data.~   "
219921|NCT00680303|"~     The purpose of this study is to evaluate the efficiency of the Lidcombe Program for early~     stuttering by varying the time between clinic visits during the first stage of the program.~   "
219922|NCT00680290|"~     The purpose of this study is to 1) assess the effect of routine exercise on the quality of~     life of patients with permanent atrial fibrillation, and 2) assess the effect of exercise on~     cardio-hemodynamics in patients with atrial fibrillation.~   "
219923|NCT00680277|"~     The goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The~     investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A~     reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Up to 45 blood samples~     (10 ml/sample) will be collected from each subject over a two-month period to evaluate the~     bioavailability and bioconversion of spirulina ß-carotene to vitamin A.~   "
219924|NCT00680264|"~     The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis~     surgical and non-operative treatment in patients with Cerebral Palsy.~   "
219925|NCT00680238|"~     Objective: To compare pregnancy rates and implantation rates when embryos are selected based~     on a single Day 3 (D.3) score vs. a GES score plus sHLA-G expression.~   "
219926|NCT00680225|"~     To report preliminary results on safety and tolerability of intravitreal injection of~     Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green~     (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.~   "
219927|NCT00680212|"~     Our objectives will be to test the following hypotheses and to make the following~     determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by~     children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The~     absorption of provitamin A carotenes and their bioconversion to vitamin A are different in~     children with or without adequate vitamin A nutrition. (3) To define the vitamin A~     equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope~     reference method in children with or without adequate vitamin A nutrition and to compare~     those values with values derived from model based compartmental analysis. (4) To determine~     the number and time of blood samples needed for future studies in various field settings on~     the retinol equivalence of a large number of plant sources.~   "
219928|NCT00680199|"~     Chronic insomnia is thought to occur as a result of hyperarousal. While there is a wealth of~     data to support this position, there is a lack of research to define how hyperarousal~     interferes with sleep initiation, maintenance, and the perception of sleep quality and~     quantity. We propose to use Event-related Potential (ERP) techniques to evaluate information~     processing at sleep onset and during sleep. ERP measures of information processing have been~     well established in good sleepers; they have not been, however, applied to the problem of~     insomnia. The goal of the project is to examine the premise that the occurrence and severity~     of insomnia is fundamentally related to a neurobiologic preparedness to attend to and~     identify environmental stimuli. Following an extensive screening, patients with insomnia~     and good sleepers will participate in two experimental conditions, requiring that they spend~     four nights in the sleep laboratory over a two week period. ERP data will be gathered prior~     to, following, and during sleep.~      The ultimate objectives for this line of research are to determine 1) if insomnia is~     associated with a failure to inhibit information processing at sleep onset and/or during~     sleep, 2) if the failure to inhibit information processing at sleep onset and/or during sleep~     is associated with the occurrence and/or severity of insomnia symptoms, 3) what brain regions~     are functioning differently so as to give rise to information processing abnormalities, and~     4) the extent to which pharmacologic and/or Cognitive Behavioral treatment for insomnia~     alters information processing abnormalities and/or the associated brain activity.~   "
219929|NCT00680186|"~     The general aim of this study is to determine the comparative safety and efficacy of~     dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN)~     to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute~     symptomatic VTE.~      The primary objective is to investigate the efficacy of dabigatran compared to warfarin~     during the 6 month treatment period. The investigation of other selected efficacy aspects and~     safety are regarded as secondary objective of this trial.~   "
219930|NCT00680173|"~     Our previous collaborative studies has developed a molecular diagnosis tool, which is~     characterized with a prediction model consisting single nucleotide polymorphisms (SNPs), for~     assessing the efficacy of interferon combined therapy for chronic hepatitis C (CHC) patients~     prior to treatment.~      Aims of this project:~        1. To analyze and validate the gene expression profiling dependent of treatment response to~          peg-interferon-α plus ribavirin combination therapy in CHC genotype-1 patients.~        2. To select the candidate genes and establish a monitoring model assessing the efficacy of~          interferon treatment.~   "
219931|NCT00680160|"~     The purpose of the study is to determine the absorption, systemic pharmacokinetics and~     accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5%~     solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult patients with~     onychomycosis.~   "
219932|NCT00680147|"~     This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV~     vaccination among low-income, African-American teens.~   "
219933|NCT00680134|"~     The purpose of the study is to determine the safety and efficacy of 1% and 5% AN2690~     solutions in the treatment of distal, subungual onychomycosis of the great toenail.~   "
219934|NCT00680121|"~     B1AS tests the hypothesis that increased vitamin B1 (thiamine) intake can repair brain~     systems damaged by alcohol and help people with alcohol problems control their alcohol use. A~     strong, man-made form of thiamine (Benfotiamine) is used to increase blood thiamine to much~     higher levels than can be achieved using normal vitamin supplements. Drinking patterns are~     examined over 6 months of continued supplement use. Men and women with a recent history of~     alcohol problems are eligible to participate.~   "
219935|NCT00680108|"~     The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic~     Solution when applied topically as eyedrops in patients with mild to moderate dry eye~     disease.~   "
219936|NCT00680095|"~     The purpose of this study is to determine the cumulative irritation potential of the products~     listed by the Sponsor.~   "
219937|NCT00680082|"~     To describe the way statins are used in France in primary care, that is to determine patients~     profile (particularly CV risk factors), to determine the way statins are initiated by general~     practitioners, to evaluate aftercare and to assess patients treated by rosuvastatin~   "
219938|NCT00680069|"~     The purpose of this research study is to study the safety and effectiveness of vaccinating~     individuals who have previously received an avian influenza vaccine derived from one type of~     H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second~     reason for this study is to compare responses in people who have received two different but~     similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the~     H5N1 vaccine used in this study. The information obtained may provide important information~     into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy~     adult volunteers, ages 19 and older, in the United States. Study procedures include: physical~     exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of~     vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side~     effects. Study participation will be approximately 7 months.~   "
219939|NCT00680056|"~     The primary objective is to comparatively evaluate the isolated effects of a long-acting~     beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a~     long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness,~     dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic~     obstructive pulmonary disease. The study hypothesis is that combining long acting~     bronchodilators with different action mechanisms would promote synergistic effects on~     clinical outcomes.~   "
219940|NCT00680043|"~     The purpose of this study is to evaluate the safety and efficacy of peginesatide for the~     treatment of anemia in participants with chronic kidney disease who are on dialysis and are~     not taking any treatment to increase their red blood cell production.~   "
219944|NCT00679991|"~     PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the~     outside surface of the blood vessel. The purpose of this study is to determine if PRT-201,~     when applied to a limited segment of blood vessel immediately after surgery to create an~     arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow~     through the AVF.~   "
220394|NCT00674050|"~     This study will investigate the effects of inhaled albuterol & fluticasone on one dose of TI~     Inhalation Powder. A total of 12 eligible subjects will be enrolled.~   "
219945|NCT00679978|"~     Osteoporotic vertebral fracture (VF) and osteonecrosis of the femoral head (OFH) are major~     concerns in patients with systemic rheumatic diseases treated with high-dose glucocorticoids~     (GCs). The investigators examined and compared the incidence and risk factors of VF with~     those of OFH in patients who had recently received high-dose GC therapy to clarify the~     relationship between these two complications.~   "
219946|NCT00679965|"~     The purpose of the study is to determine the safety and efficacy of 2.5%, 5.0%, and 7.5%~     AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual~     onychomycosis of the great target toenail.~   "
219947|NCT00679952|"~     Pancreaticojejunal anastomosis leakage is a major complication after pancreatoduodenectomy~     and various technical methods have been examined to improve the situation.However, none of~     methods have been successful at improving results according to the findings of prospective~     randomized studies. We propose that active drainage of pancreatic juice using suction~     drainage might maximize the advantage of a stent and finally reduce pancreaticojejunal~     anastomosis leakage.~   "
219948|NCT00679939|"~     The purpose of this study is to determine the effects of rosiglitazone on the bone in~     postmenopausal women with type 2 diabetes mellitus~   "
219949|NCT00679926|"~     Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r,~     800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50~     copies/ml in antiretroviral naïve patients through 48 weeks of therapy.~   "
219950|NCT00679913|"~     This study was designed to test the hypothesis that more extensive nodal and soft-tissue~     clearance in patients with adenocarcinoma of the head of the pancreas would improve survival~     without an increase in morbidity and mortality.~   "
219951|NCT00679900|"~     The primary objective is to compare the potential for next-day residual effects of~     eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning~     using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic~     primary insomnia and sleep maintenance difficulties.~      The secondary objectives are to compare the clinical safety of both products, including the~     potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to~     compare the efficacy of both products on subjective sleep parameters and to compare the~     effects of both products on patient's daytime functioning.~   "
219952|NCT00679887|"~     The purpose of this study is to find the efficacy of treating the trigger points located~     around the shoulder in patients suffering from chronic shoulder pain.~   "
219953|NCT00679874|"~     Consecutive patients with a first diagnosis of breast cancer will be identified at the Tom~     Baker Cancer Centre (TBCC) and included into the study, if they are going to receive~     chemotherapy with anthracyclines and / or Trastuzumab and do not have contra-indications for~     the CMR study. Besides the usual clinical care for these patients (e.g. blood samples before~     each cycle of chemotherapy; MUGA scans to follow cardiac size and function), the patients~     will undergo serial contrast-enhanced CMR studies (before, during and 9-12 months after~     completion of the chemotherapy); patients will be seen at an outpatient clinic in the Dept.~     of Cardiac Sciences / Heart Function Clinic for a clinical assessment (including ECG,~     additional blood test like Troponin-T, BNP, 6-minute-walk-test) and recommendations will be~     made to medical treatment in patients with evidence for heart failure.~      Time points for the CMR and clinic assessments will be co-coordinated with regularly~     scheduled test by the TBCC to avoid unnecessary burden for the patients. The oncologists at~     the TBCC will be blinded to the results of the CMR studies and to laboratory results, unless~     the participating cardiologists identify a clinical need for communication.~      Standardized CMR protocols will be employed and all interpretations will be blinded to the~     time course of the chemotherapy and cardiotoxic side effects.~      We will test the hypothesis, whether CMR can be useful in patients with potentially~     cardiotoxic chemotherapy to:~        -  Identify patients at risk for the development of grade 2-4 cardiotoxic side effects as~          classified by the NCI guidelines (common toxicity criteria, 2001, 1-12)~        -  Identify imaging parameters to predict early or late Cardiotoxicity~        -  Provide additional clinical information to optimize medical treatment for heart failure~   "
219954|NCT00679861|"~     Primary care physicians can play an important role in reducing tobacco smoking in the~     population. The general practice is a suitable setting for implementing proactive smoking~     interventions, because a large proportion of the population can be regularly reached in a~     favorable psychological state. Further, a trustful interpersonal relationship between the~     practitioners and their patients is supposed to increase the susceptibility to preventive~     measures. However, currently general practitioners are not capitalizing this advantage~     although evidence based treatments are available, which are effective and cost-effective.~     Outreach programs combining educational and practice-based measures have been found to be~     effective in engaging practitioners in screening and in giving advice. Computer expert-system~     and brief counseling interventions, which are based on the Transtheo-retical Model of~     behavior change (TTM), are promising approaches for the entire population of practitioners~     and smoking patients. For large scale implementation, data are needed about the degree of~     integration in every day routine clinical practice that could be achieved by implementing~     such interventions. Objectives: Evaluating different strategies for the implementation of~     proactive smoking interventions in general practices. Methods: In a randomized controlled~     trial, 150 randomly selected general practices of a defined German region will be included.~     The procedure comprises the implementation of 1) an on-site computer expert-system~     intervention, 2) a counseling intervention provided by the practitioner, or 3) the computer~     expert-system plus the counseling intervention. During an implementation phase of one month,~     two on site training sessions and support by phone will be provided. Routine use of the~     interventions will be monitored for the following 6 months. Main outcome measures are the~     number and rate of identified and treated smokers. A follow-up assessment will be realized 12~     months after practice attendance to determine the smoking status of the treated smokers.~   "
219955|NCT00679848|"~     The purpose of this study is to evaluate the safety, technical feasibility, and initial~     effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR~     performed using the Bard RESTORe Suturing System~   "
219956|NCT00679835|"~     This is a research study designed to look at the pharmacokinetics (distribution, breakdown,~     and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years~     who have infections that are caused by a specific group of bacteria (called Gram-positive~     bacteria).~   "
219969|NCT00679666|"~     Prospective, randomized, single site to determine the safety and effectiveness of performing~     corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive~     keratoconus or corneal ectasia.~   "
219970|NCT00679653|"~     To study the effect of sibutramine treatment on weight reduction and blood pressure~     improvement in three groups with antihypertensive therapy whose blood pressure was not~     adequately controlled with antihypertensive combination treatment.~   "
219957|NCT00679822|"~     The objective of this protocol is the evaluation of our clinical screening program for sleep~     disorders in patients with heart failure.~      These patients have very high prevalence of Sleep Disordered Breathing (SDB), including~     central and obstructive sleep apnea. There is also strong evidence that SDB, if unrecognized~     and untreated, will worsen heart failure and may leads to serious complications. Effective~     treatment of SDB results in improvement in heart failure and functional status. So far there~     are no guidelines in the area of screening in this patient population. The only test that~     would reliably rule out or confirm SDB is the polysomnography (PSG) this test is expensive~     and technically demanding. With the current approach to diagnosis and treatment of SDB, it~     routinely takes up to 5-6 months between the emergence of clinical suspicion of SDB and the~     initiation of appropriate treatment with CPAP. This delay and cost of this traditional~     approach, is a significant obstacle to providing highly needed care to this very vulnerable~     population.~      In OSU we have a state of the art Heart Failure Program and a Sleep Heart program that was~     created to develop an approach to prompt diagnosis and treatment of SDB in our heart failure~     patients. We designed an algorithm that employs validated questionnaires and FDA approved~     devices. We need, however to validate our algorithm against the gold standard: the PSG.~     Furthermore, we need to analyze the prevalence and risk factors of each sleep disorder in~     light of the recent changes in the management of heart failure, which may have influenced the~     risk factors and prevalence as we knew them. This protocol includes a combination of~     clinically indicated procedures, and others that are repeated for validation purposes. The~     accumulation and analysis of data is also done for research purposes.~   "
219958|NCT00679809|"~     The purpose of this study is to describe the features of continuity and quantify fatigue in~     three ICU resident work schedules, estimate the frequency of preventable adverse events, and~     inform the design and demonstrate the feasibility of a future multi-centre study.~   "
219959|NCT00679796|"~     This study is undertaken to evaluate the effectiveness of currently licensed varicella~     vaccines under conditions of routine use in a setting where varicella vaccine is included in~     the childhood immunization calendar.~   "
219960|NCT00679783|"~     This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with~     recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers~     to identify objective response rate and to assess for early markers of activity and to assess~     correlative markers that may provide helpful information for subsequent clinical trials.~     Approximately 110 patients from 7 centers in Canada will be enrolled into this study.~   "
219961|NCT00679770|"~     The purpose of the study is to determine the safety and efficacy of 2.5%, 5.0%, and 7.5%~     AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual~     onychomycosis of the great target toenail.~   "
219962|NCT00679757|"~     This study is looking at the prevalence of sleep apnea in a wound center population. It uses~     both screening surveys and take home devices. Some measures of wound healing ability are~     being looked at as well.~   "
219963|NCT00679744|"~     Adult Tay-Sachs disease and Sandhoff diseases are caused by deficiency of an enzyme called~     β-hexosaminidase A, or Hex A in short. This enzyme is located in a particular cellular~     component, called lysosomes, inside the brain cells. The reason that Hex A of patients with~     Adult Tay-Sachs disease or Sandhoff disease is deficient is because this enzyme had gone~     through mutation, resulting in it not working very well. In healthy people, Hex A efficiently~     breaks down GM2-ganglioside, which is a by-product from cells of our body. However, patients~     with Adult Tay-Sachs disease or Sandhoff disease cannot efficiently break down~     GM2-ganglioside in the body. Therefore, these patients have high levels of this by-product in~     the brain cells, which causes the brain to be unable to function normally.~      There is a drug called Pyrimethamine. This drug is used by doctors to treat specific types of~     infections called malaria and toxoplasmosis. Our laboratory test tube studies have shown that~     Pyrimethamine can help the Hex A enzyme to function in a normal manner. If Hex A can function~     normally in presence of Pyrimethamine, this drug should be able restore the brain malfunction~     of these patients since Hex A can now efficiently break down GM2-ganglioside with~     Pyrimethamine treatment.~      Although results from laboratory test tube studies are promising and Pyrimethamine should~     theoretically restore brain function of these patients, we do not know if Pyrimethamine is~     safe or if it would actually work in patients. This study is the first study (a Phase I~     study) of testing Pyrimethamine to treat Adult Tay-Sachs and Sandhoff diseases. The objective~     of this study is to see if Pyrimethamine is safe in these patients and to see if it can~     restore the brain function of these patients.~   "
219964|NCT00679731|"~     This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in~     subjects with moderate to severe plaque psoriasis.~   "
219965|NCT00679718|"~     To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in~     patients with moderate to severe dry eye disease.~   "
219966|NCT00679705|"~     This trial will consist of two parts:~      A pilot study in a three-way cross over trial to determine the highest well tolerated dose of~     Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the~     design of the final study.~      The final study is planned as a three-way crossover trial to investigate and compare the~     cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the~     pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).~   "
219967|NCT00679692|"~     BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell~     growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1~     (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone~     (HGH) in the progression of chronic liver disease remain to be elucidated and investigated.~      METHODS The subjects in the present study included 60 healthy controls, 30 hepatitis~     patients, 60 liver cirrhosis patients and 60 untreated hepatocellular carcinoma patients.~     Blood was drawn by venipuncture into Venoject tubes. To find the possible correlations~     between liver damage and IGFs, serum IGF-1, GH, IGFBP-3 concentration and related biochemical~     parameters were measured. We used immunoradiometric assay to determine the levels of IGF-1,~     HGH and IGFBP-3 in serum.~   "
219968|NCT00679679|"~     Polycystic ovary syndrome is a frequent cause of abnormal menses and infertility. It has also~     been related to cardiovascular disease.~      The objective of this trial is to evaluate the clinical and metabolic efficacy of metformin~     plus life style modifications in women with polycystic ovary syndrome compared with life~     style modifications and placebo~   "
219973|NCT00679614|"~     Patients over 70 years of age, scheduled for joint replacement surgery will be randomized to~     tramacet/ naloxone plus morphine PCA or to morphine PCA to assess quality of analgesia in the~     postoperative period.~      The primary objective is to determine opioid use during combined use of oral tramacet and~     naloxone infusion perioperatively in elderly patients (70 yrs and older) having elective~     knee/ hip arthroplasty under spinal anesthesia.~      Secondary objectives are to determine the incidence VAS scores ≥4 and adverse effects such as~     nausea, vomiting, sedation, respiratory depression, pruritus, confusion, and time of~     independent mobilization.~      Hypothesis: Perioperative naloxone infusion and tramacet provides adequate analgesia in~     elderly patients undergoing total knee/hip arthroplasty and is associated with 80% reduction~     in opioid use and reduced opioid-induced side effects.~   "
219974|NCT00679601|"~     The purpose of the study is to determine the absorption and systemic pharmacokinetics of~     AN2690 following daily application to all ten (10) toenails for 28 days.~   "
219975|NCT00679588|"~     The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous~     (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for~     the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal~     surgery.~      The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to~     document Semuloparin sodium (AVE5026) exposure in this population.~   "
219976|NCT00679575|"~     The main objective of this case-referent study is to assess the impact of statins usage on~     the risk of having a first myocardial infarction (MI) in a real life situation in France~   "
219977|NCT00679562|"~     Primay objective:~      To evaluate the potential of the products in eliciting adverse skin reaction.~   "
219978|NCT00679549|"~     This study will evaluate whether treating sleep apnea while in the hospital would help heart~     failure, and assist recovery from the worsening of the heart function more than the current~     clinical standard of waiting for treatment until the subject have left the hospital.~      Heart failure affects more than 2% of the US population and is the only cardiovascular~     disorder with rising incidence. The annual cost of CHF in 2005 was $ 27.9 billion, large~     percentage of which is the cost of hospitalizations for exacerbation of CHF. Half of patients~     with CHF have some form of sleep apnea, and most of them go undiagnosed. Patients with CHF~     and OSA benefit from treatment with CPAP as an outpatient. The society can benefit from~     developing recommendations for approaching sleep apnea in the hospitalized CHF patient, which~     may shorten length of stay, improve functional status of discharged patient, and reduce~     rehospitalizations.~   "
219979|NCT00679536|"~     The study proposes the use of Fludarabine, Busulfan, Anti Thymocyte Globulin Rabbit (ATG) and~     Total Body Irradiation as a preparative regimen before hematopoietic stem cell transplant~     from unrelated donor peripheral blood stem cells (PBSC). The hypothesis states that the 100~     day mortality after this type of transplant will be significantly below the accepted~     standards, which is about 30% for unrelated donors.~   "
219980|NCT00679523|"~     The purpose of the study is to determine the safety and efficacy of 5.0% and 7.5% AN2690~     Solution in the treatment of distal, subungual onychomycosis of the great target toenail.~   "
219981|NCT00679510|"~     Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. Our~     study is aimed at looking at the effects of proven cholesterol lowering treatment drug called~     rosuvastatin in rheumatoid arthritis patients on few cardiovascular markers. Endothelial~     behaviour improved on treatment.~   "
219982|NCT00679497|"~     The purpose of this clinical trial is to study a modified pox viral vector considering:~        1. HIV subtype B accounts for the most frequent virus strain in Europe and North America,~          as well as in many parts of the world.~        2. This novel vaccinia construct expressing HIV subtype B gag, pol, env and nef antigens is~          to be studied in humans for the first time.~   "
219983|NCT00679484|"~     This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a~     prognostic biomarker of heart failure, at week 24~   "
219984|NCT00679471|"~     The purpose of this study is to see how full-term and pre-term infants' brains relate to~     their movement and development throughout the first two years of life. All infants who~     participate in this study will have a magnetic resonance image (MRI) of the brain prior to~     discharge from the hospital. Infants will then have follow-up appointments every 3-6 months~     at home or at the Infant Motor Behavior Laboratory at the University of Delaware. The~     follow-up sessions will test how infants change their movements to respond to interesting~     objects or sounds in their environment. It is hoped that the results of this study will~     assist clinicians in developing better testing and treatment methods for those infants at~     risk for developmental problems.~   "
219985|NCT00679458|"~     This study compares two medications for analgesic potency and side effects in a sample of~     individuals with moderate pain. After screening, eligible participants will be randomly~     assigned to begin blinded treatment with one of two medications. Participants receive 5 daily~     doses of medication (no more than 2 days between each dose) followed by crossover to the~     opposite treatment condition for 5 additional daily doses. Each study day, participants will~     provide a daily pain assessment, receive administration of study medication, and will then be~     monitored and assessed for pain and side effects over 6 hours.~   "
219986|NCT00679445|"~     The objective of this clinical study is to evaluate the safety and feasibility of focal~     delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) in~     patients with age related macular degeneration that have failed Primary Anti-VEGF therapy.~   "
219987|NCT00679432|"~     The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets~     to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if~     Budesonide MMX™ is effective in the treatment of ulcerative colitis.~   "
220017|NCT00679042|"~     In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free~     immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the~     safety of islet preparation, iset transplantation, and medical treatment at UIC. Therefore,~     the primary purpose of the present Phase 3 clinical trial is to demonstrate the safety and~     efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic~     patients using the UIC protocol that was developed and proven effective during the Phase 1/2~     clinical trial.~   "
253010|NCT00239824|"~     The aim of this study is to evaluate the effect of pelvic floor muscle training in the~     treatment of urinary incontinence after radical prostatectomy.~   "
219988|NCT00679419|"~     It is the aim of the multi-centric and prospective registry to analyze in patients with CAD~     the impact of different grades of renal failure on the outcome and course of the patients and~     to correlate these with clinical variables.~      In particular, the registry has the following objectives:~        -  prospective consecutive assessment of all patients with coronary artery disease and~          renal failure in the participating hospitals of the registry~        -  evaluation of the outcome and course of patients with regard to their different stages~          of renal failure at baseline~        -  analysis of the impact of different therapeutic strategies on acute and long-term~          outcomes~        -  identification of clinical risk factors, novel biomarkers and genetic markers for an~          unfavorable long-term outcome~   "
219989|NCT00679406|"~     The purpose of this study is to adapt and test the effects of a 4-week behavioral treatment~     that targets chronic insomnia (lasting >1 month) in service members returning from Operation~     Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF).~   "
219990|NCT00679393|"~     A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres~     across Canada. It will compare patients who receive open reduction, internal fixation for~     Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same~     type of fracture. Patients will be followed up for a period of two years from the time of~     operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12~     months, and 24 months.~   "
219991|NCT00679380|"~     This will be a multicentre, randomised, double-blind, double-dummy, parallel group~     comparative study in patients with mild or moderate, active ulcerative colitis. The study~     will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to~     Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment~     period.~      After the screening visit, patients will enter a washout period of 2 days, then they will be~     randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg),~     budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and~     capsules), all administered once a day after breakfast. Hence, each patient will receive, in~     the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet~     and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo~     budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three~     placebo Entocort® matching capsules.~   "
219992|NCT00679367|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different~     ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping~     them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune~     system in different ways and stop the abnormal plasma cells from growing. Giving melphalan~     together with lenalidomide and dexamethasone may be an effective treatment for primary~     systemic amyloidosis.~      PURPOSE: This phase II trial is studying the side effects and how well giving melphalan~     together with lenalidomide and dexamethasone works in treating patients with primary systemic~     amyloidosis.~   "
219993|NCT00679354|"~     This phase II trial studies how well cilengitide works in treating younger patients with~     recurrent or progressive high-grade glioma that has not responded to standard therapy.~     Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.~   "
219994|NCT00679341|"~     This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial~     designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the~     combination of trastuzumab and docetaxel in patients with human epidermal growth factor~     receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic~     breast cancer who have not received prior chemotherapy for metastatic disease.~   "
219995|NCT00679328|"~     This study is to evaluate the safety and effectiveness of the OP device for the treatment of~     nonunion bone fractures and to compare the healing rates of the OP Device to that of~     autograft.~   "
219996|NCT00679315|"~     The purpose of this study is to explore the efficacy of Alfuzosin (10 mg, qd) in reducing the~     score of International Prostate Symptom Score (IPSS) from baseline to 8 weeks of treatment in~     female patients with voiding dysfunction.~   "
219997|NCT00679302|"~     The purpose of this study is to determine if antibiotics are required in the management of~     skin abscess following incision and drainage.~   "
219998|NCT00679289|"~     This was a Phase 2, open-label study of KW2871 (ecromeximab) in combination with high-dose~     interferon-α2b (HDI) in patients with metastatic melanoma. The primary objectives of this~     study were to assess progression-free survival (PFS) and safety. The secondary objectives~     were to assess the objective response rate, KW2871 pharmacokinetics (PK), and other~     exploratory immunology as indicated (e.g., development of human anti-chimeric antibodies~     [HACA], activity of antibody-dependent cell-mediated cytotoxicity [ADCC] and~     complement-dependent cytotoxicity [CDC] in peripheral blood, number and functional state of~     tumor-infiltrating immune cells and expression of GD3 in immune and tumor cells of tumor~     biopsies, and markers of interferon [IFN] response/resistance and markers of resistance to~     ADCC/CDC in peripheral blood mononuclear cells [PBMCs]).~   "
219999|NCT00679276|"~     Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary~     Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital.~   "
220000|NCT00679263|"~     The purpose of this study is to evaluate the safety and tolerability of MN-221 at two~     different dosing rates administered through a continuous infusion in subjects diagnosed with~     moderate to severe asthma.~   "
220018|NCT00679029|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,~     paclitaxel, and gemcitabine hydrochloride, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as bevacizumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by~     blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab~     after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects and how well giving combination~     chemotherapy together with bevacizumab works in treating women with HER2/neu-negative stage~     II or stage III breast cancer~   "
253054|NCT00239252|"~     Efficacy and safety is compared between interferon alfacon-1 alone and concomitant dosing of~     interferon alfacon-1 and ribavirin in hepatitis C patients.~   "
220001|NCT00679250|"~     Allergic rhinitis is a common condition characterize by inflammation of the upper airways.~     Third generation antihistamines have been demonstrated effective in the treatment of this~     condition. Allergen challenge can be use to assess the effects of drugs in allergic rhinitis,~     adenosine monophosphate may also be used as a means to investigate these effects but as yet~     its effects have yet to be compared to allergen challenge. We intend to compare the effects~     of levocetirizine at a single dose of 5mg on allergen and AMP challenge compared to placebo~     in a double blind cross-over study. The study will include 20 patients with allergic~     rhinitis. Each patient will have allergen and AMP challenge on placebo and active treatment.~     The primary outcome variable will be the change in concentration of AMP/Allergen required to~     produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. A 1 doubling~     dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be~     deemed significant. We will also measure time to recovery after both challenges. AMP~     challenge is a safe alternative to allergen challenge and does not have the risk of~     anaphylaxis.~   "
220002|NCT00679237|"~     Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk~     of new coronary heart disease and death~   "
220003|NCT00679224|"~     The purpose of the programme is to collect safety data on ambrisentan when used in clinical~     practice~   "
220004|NCT00679211|"~     Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth~     factor receptor 2 (HER2)-positive metastatic breast cancer.~   "
220005|NCT00679198|"~     SPECIFIC AIMS: We propose a three-year study to develop a high-intensity intervention to~     improve osteoporosis care and test a novel intervention in a group-randomized trial of 27~     home health offices and 1,000 patients referred to home health care with a history of~     fracture.~      Aim 1. Develop an intervention to promote osteoporosis treatment that includes: (1) training~     to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and~     fracture risk; (2) automated prompts within the home health agency's electronic medical~     record system to promote appropriate osteoporosis management; and (3) implementation of~     osteoporosis-related standardized care pathways and order sets.~      Aim 2. Conduct a group-randomized trial to test the effectiveness of the intervention to~     promote initial use of osteoporosis medications and adherence to treatment after discharge~     from home health. We hypothesize that:~      H1: Patients in the intervention group will have increased initial receipt of osteoporosis~     prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis~     compared to patients receiving usual care; H2: Patients in the intervention group will~     demonstrate increased persistence in the use of these therapies compared to those receiving~     usual care.~      Secondary Aims (SA) will include exploratory analyses of fracture related morbidity and~     mortality, patient-reported quality of life, and health services utilization and costs.~   "
220006|NCT00679185|"~     RATIONALE: Expressive writing may help relieve symptoms and improve quality of life in breast~     cancer survivors with chronic lymphedema.~      PURPOSE: This clinical trial is studying expressive writing in improving the quality of life~     in women with breast cancer and lymphedema.~   "
220007|NCT00679172|"~     This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever~     vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.~     The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.~   "
220008|NCT00679159|"~     This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children~     and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and~     highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we~     will vaccinate 24 children with 5 x 10^7pfu of MVA85A and three groups of 36 infants with 2.5~     x 10^7, 5 x 10^7 or 1 x 10^8 pfu.~      Participants will be identified from the general population living in Worcester, Western~     Cape, South Africa~   "
220009|NCT00679146|"~     Primary Objective :~      To demonstrate the superiority of the oral fixed - combination of a muscle relaxant,~     thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC,~     on average pain within the last 24 hours in adults suffering from acute non specific low back~     pain with an episode of recent onset~      Secondary Objective :~      To compare the safety of the oral combination to that of oral TCC alone~   "
220010|NCT00679133|"~     In this study, MGCD265, a new anticancer drug under investigation, is given daily on a 7 days~     on / 7 days off schedule to patients with advanced malignancies to study its safety profile.~   "
220011|NCT00679120|"~     The purpose of this scientific study is to clarify whether there is a relationship between~     the appearance of radiolucent lines in bone-cement interphase of the tibial component of the~     different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses.~     This will be accomplished in a se-ries of three different Oxford Uni Knees.~   "
220012|NCT00679107|"~     This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the~     treatment of spinal decompression and lumbar spinal fusion.~   "
220013|NCT00679094|"~     This randomized phase I trial is studying the side effects and best dose of Bowman-Birk~     inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep~     cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.~   "
220014|NCT00679081|"~     The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in~     the treatment of subjects with Miller Class I or II recession defects who desire root~     coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative~     to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and~     wound healing.~   "
220015|NCT00679068|"~     Bosentan has been largely used in the treatment of pulmonary hypertension (PH). It can~     improve exercise capacity, lower Borg dyspnoea score nad these effects are usually associated~     with the concomitant improvement in cardiopulmonary haemodynamics.~      No physiological study has so far verified the hypothesis that Bosentan may laso have an~     effect on the respiratory side of the cadio-pulmonary system (i.e. on pulmonary mechanics~     and work of breathing)~   "
220016|NCT00679055|"~     A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary~     hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a~     decrease in lower extremity atherosclerotic plaque macrophage content when compared to~     placebo (an approximate decrease of up to 30% is expected).~   "
220019|NCT00679003|"~     Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in~     significant life disruption, hospitalization and surgery. While psychosocial factors are not~     believed to cause IBD, such factors can contribute to the ability of individuals with IBD to~     cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms.~     The goal of this study is to evaluate the efficacy of a social learning and cognitive~     behavior therapy approach for treating children with IBD. The primary outcomes of interest~     are IBD symptoms, medical visits, quality of life, and overall disability.~   "
220020|NCT00678990|"~     In this study the islets will be surface modified to carry immobilised heparin (Corline~     Heparin Conjugate) prior to transplantation. The primary objective is to investigate safety~     and efficacy of allogeneic islet transplantation using islets coated with immobilised~     heparin. The modification with heparin has been shown to protect the islets from being~     attacked by the immediate defence systems in blood (coagulation and inflammation), so that a~     larger portion of the islets will survive the initial phase and engraft. Evaluation will be~     based on metabolic and blood chemistry parameters.~   "
220021|NCT00678977|"~     This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and~     tolerability and to determine the optimal tolerated regimen(OTR) of pazopanib in combination~     with gemcitabine (Arm A) or pazopanib, gemcitabine, and cisplatin (Arm B) in patients with~     advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses~     of pazopanib and gemcitabine or pazopanib, gemcitabine and cisplatin. Dose escalation schemas~     for each study arm are described in the protocol. For each arm, the OTR will be defined as~     the highest dose combination of the agents where no more than one out of six patients~     experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be~     studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment~     of potential drug-drug interactions. Antitumor activity will be assessed using RECIST~     criteria.~   "
220022|NCT00678964|"~     60% of all malignant diseases occur in patients who are 65 years or older. For these~     patients, aggressive treatments are often not suitable due to reduced life-expectancy,~     reduced general condition, comorbidities, and reduced vital functions which can lead to~     increased adverse effects of chemotherapy. Therefore, it is important to investigate~     alternative therapy options for elderly patients.~      Erlotinib is an orally applied medication which is associated with reasonable toxicity. This~     targeted agent may prove an effective and well-tolerated first-line therapy in elderly~     patients with advanced non small cell lung cancer.~      Therefore, the aim of this study is to investigate the progression-free survival of the~     combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will~     be no significant reduction of efficiency this may provide elderly patients of more than 70~     years of age with an active oral substance without subjecting them to the sometimes severe~     adverse effect of the chemotherapy.~   "
220023|NCT00678938|"~     The study takes up two problems: 1) Little research exists about general population~     interventions for smokers not ready to quit within the foreseeable future. 2) There is little~     evidence for smoking reduction as a behavioural goal in interventions. Interventions based on~     the Transtheoretical Model of Behavior Change (TTM) using computer expert-system technology~     yield delayed and smaller effects in smokers in the precontemplation stage of change compared~     to smokers in more advanced stages of change. Reducing the number of cigarettes smoked per~     day is currently discussed as an intermediate goal for this subgroup. Epidemiological and~     clinical studies revealed that smokers are able to maintain a substantial reduction. No~     undermining effects with respect to smoking cessation have been found. However, there are no~     studies that test the efficacy of behavioural interventions for smoking reduction using~     population based recruitment. Objectives: Testing the efficacy of TTM based interventions for~     general population smokers not intending to quit smoking, i.e. a smoking-reduction and a~     smoking-cessation tailored intervention using computerized expert-system technology.~   "
220024|NCT00678925|"~     Studies have shown that choline is a necessary part of the human diet. Choline is important~     in making membranes for all the cells in the body, and for making chemicals that are~     responsible for nerve function. Studies have also shown that choline improves memory of rats~     when they are given choline at early stages in their lives. The purpose of this study is to~     find out whether choline supplementation (provided as a choline dietary supplement) in~     pregnant women will improve memory function of their babies after they are born.~      In this study, we hypothesize that high dietary choline consumption during pregnancy and~     lactation will:~        1. Increase maternal choline concentration in plasma~        2. Increase breast milk choline concentration~        3. Enhance memory performance in the children born of supplemented mothers~   "
220025|NCT00678912|"~     The purpose of this study is to determine whether a computer-driven system (Smartcare/PS)~     decreases weaning duration from mechanical ventilation when compared to usual care in~     children.~   "
220026|NCT00678899|"~     The purpose of this study is to evaluate the safety and efficacy associated with the~     provision of acoustic and electric sound processing to individuals who demonstrate~     significant residual low-frequency hearing and profound high-frequency (above 1500 Hz)~     sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the~     Nucleus Hybrid L24 cochlear implant system.~   "
220027|NCT00678886|"~     The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads~     to greater improvement in insulin secretion as compared with placebo infusion. Insulin~     secretion will be assessed using mixed meal-stimulated C-peptide.~      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3~     otelixizumab, 1/3 placebo). These study agents will be administered as an addition to~     insulin, diet, and other physician determined standard of care treatments.~      DEFEND-1 is now closed to enrollment.~      DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require~     subjects with new onset type 1 diabetes. Please check back here for more details.~      In the meantime, established and new onset type 1 diabetes patients in North America are~     welcome to consider the TTEDD study:~      http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD&rank=1~   "
220028|NCT00678873|"~     The investigators aim to investigate the safety, feasibility and short-term outcomes of~     Single Incision Laparoscopic Cholecystectomy.~      The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and~     feasible.~   "
220029|NCT00678860|"~     This study will test and compare computerized and paper versions of eye questionnaires.~     Questionnaires are used in medicine to gain a better understanding of how a disease can~     impact a person's quality of life. Computerized versions of such questionnaires are often as~     good as or better than paper versions, but there has been no direct comparison of the two.~     This study may help in the development of eye questionnaires used to understand symptoms and~     monitor patients in clinical trials.~      People 21 years of age and older with ocular surface disease (OSD) and matched control~     subjects without OSD may be eligible for this study. All participants undergo the following~     procedures:~        -  Medical and eye history.~        -  Vision test and examination of the front part of the eye.~        -  Tear measurement: A small piece of paper is placed on the surface of the eye to measure~          the amount of tears produced. The consistency of the tears is measured by looking at how~          fast they evaporate from the surface of the eye.~        -  Completion of either paper-based or computer-based version of a questionnaire 15 minutes~          after the eye examination and completion of the other version within 1 week at home.~          (Subjects who complete the paper version in the clinic are told how to access the~          computer version online at home or on a library computer; those who complete the~          computer version in the clinic are given a paper version to take home.)~   "
220030|NCT00678847|"~     Indication: Subjects with chronic venous leg ulcers~      Primary Objective:~      • To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic~     venous leg ulcers~      Secondary Objective(s):~        -  To evaluate the percentage of wound healing every two weeks~        -  To evaluate the complete ulcer healing every two weeks~        -  To evaluate the time to complete ulcer healing~        -  To evaluate the recurrence rate at the end of the follow-up period~        -  To evaluate pain~        -  To evaluate the quality of life~      Study Design and Treatment Scheme:~      This is a Kingfisher Healthcare NV sponsored, national, multicenter, randomized, prospective~     study in which data will be collected of subjects with chronic venous leg ulcers receiving~     standardized conventional therapy (SCT). Subjects will be randomized into two groups~     receiving SCT + placebo or SCT + bio-electrical stimulation therapy (BEST) to evaluate the~     effect of BEST on the wound healing process.~      Patients answering the eligibility criteria will receive standardized conventional therapy~     during 4 weeks before actual study start and will then again be evaluated on eligibility~     according to wound healing rate. Only patients with a wound surface that has not~     significantly changed (both increased or decreased) will be randomized in the treatment~     period.~      During the treatment period patients will receive SCT with placebo or SCT in combination with~     bio-electrical stimulation therapy on a daily basis for two hours, during 8 weeks.~      Patients will be in follow-up period for a maximum of 8 weeks after treatment period.~   "
220031|NCT00678834|"~     Levels of tocotrienol in human tissues following supplementation is not currently known. The~     objective of this present study is to determine the levels of this form of vitamin E in the~     human tissues such as skin, heart, lung, liver, adipose tissue, Brain and cerebrospinal fluid~     (CSF) following oral supplementation~   "
220032|NCT00678821|"~     This study will determine if a rehabilitation exercise program can help people with pulmonary~     hypertension (PH) increase their physical activity. Patients with PH have an increase in~     blood pressure in the pulmonary blood vessels (artery, vein or capillaries) that leads to~     shortness of breath, dizziness, fainting and other symptoms.~      Healthy volunteers and people with pulmonary hypertension between 21 and 75 years of age may~     be eligible for this study.~      All participants undergo the following tests and procedures:~        -  Medical history and physical examination~        -  6-minute walk test: Subjects walk as fast as they can for 6 minutes on a walking track~          to determine their ability to participate in physical activity.~        -  Questionnaires: Subjects complete nine questionnaires related to their fatigue, daily~          physical activity, mood, and so forth.~        -  Maximum treadmill test: The exercise begins at an easy level and gradually increases~          until the subject says he or she can no longer continue or the investigator decides it~          is not safe to continue. Subjects are fitted with a mask, electrodes and light sensors~          to measure how well the heart is working and how well the muscles use oxygen.~      Patients with pulmonary hypertension undergo the following additional procedures:~        -  Activity monitoring: Patients wear a monitor for 3 days that measures movement and heart~          rate.~        -  Group assignment: Patients are randomly assigned to Group 1 (education plus aerobic~          exercise) or Group 2 (education followed by exercise).~        -  Group 1 patients will attend classes three days a week at either Inova Fairfax Hospital~          Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. Two~          sessions a week will include a 1 hour education session as well as a 30-45 minute track~          or treadmill exercise session. The third session will only include exercise. During the~          education patients will learn about a healthy lifestyle with pulmonary hypertension.~          After the 10 weeks of education and exercise, subjects repeat the 6-minute walk test,~          maximum treadmill test and questionnaires.~        -  Group 2 patients participate in 2; 1-hour educational session at either the Inova~          Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. After~          the classes, they repeat the 6-minute walk test, maximum treadmill test and~          questionnaires. The following 10 weeks will consist of 3 days a week of 30-45 minute~          track or treadmill walking at either Inova or NIH, after which they again repeat the~          questionnaires, treadmill and walk tests.~   "
220033|NCT00678795|"~     The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in~     reducing the daily number of episodes on incontinence.~   "
220034|NCT00678782|"~     To assess the therapeutic efficacy, of the clinical response of intraarticular (IA)~     etanercept (E) 12.5 mg or placebo (P: NaCl) injections into single knee arthritic joint of~     patients with refractory knee joint synovitis (KJS), administered once every two week, for~     eight weeks, with cross over after 2 weeks, in two groups of randomly assigned patients, for~     whom traditional systemic disease-modifying antirheumatic drugs (DMARDs) is insufficient or~     inappropriate. The primary outcome measure is the Thompson articular index of KJS disease~     activity.~   "
220035|NCT00678769|"~     This phase I trial studies the side effects and best dose of cixutumumab and temsirolimus in~     treating patients with locally advanced or metastatic cancer. Monoclonal antibodies, such as~     cixutumumab, can block cancer growth in different ways. Some block the ability of cancer~     cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Temsirolimus may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may kill more~     cancer cells.~   "
220036|NCT00678756|"~     Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected~     psoriatic skin~   "
220037|NCT00678743|"~     The primary objective of this trial is to assess the continued efficacy of Omacor~     co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol~     (non-HCL-C) levels.~   "
220038|NCT00678730|"~     This study attempts to examine genetic influences on the effects of tetrahydrocannabinol~     (Δ9-THC), the active ingredient of marijuana, cannabis, ganja, or pot.~   "
220109|NCT00677794|"~     There remains debate regarding whether small bowel cleansing is required prior to video~     capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing~     with no preparation, preparation with picosalax, and preparation with polyethylene glycol.~   "
220039|NCT00678717|"~     The purpose of this study is to assess the effect of the spinal cord stimulator (A small wire~     is surgically implanted under the skin. Low-level electrical signals are then transmitted~     through the lead to the spinal cord to alleviate pain. Using a magnetic remote control, the~     patients can turn the current on and off, or adjust the intensity.) on the autonomic nervous~     system (sympathetic and parasympathetic). Some studies support that the spinal cord~     stimulation suppresses or decreases sympathetic outflow (the sympathetic nervous system is~     the one that provide us with the flight and fight response and the parasympathetic nervous~     system is the one that works while we sleep, rest and digest.). The sympathetic nervous~     system is important in blood pressure regulation also. However, there are not reports~     regarding the effect of the spinal cord stimulation on blood pressure regulation in chronic~     visceral pain patients. Most clinical trials are focus on the effect of the spinal cord~     stimulation on pain relief. We think we could use blood pressure, heart rate and special~     analysis of these signals and their relationship to other pain measurements to assess the~     effect of the spinal cord stimulation in an objective way.~   "
220040|NCT00678704|"~     The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was~     confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was~     no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg~     regimens. Overall the tolerability was considered good with both regimens.~   "
220041|NCT00678691|"~     Armodafinil (NuvigilTM) is an isomer of a drug currently approved by the FDA for the~     treatment of fatigue secondary to narcolepsy, sleep apnea, and shift work sleep disorder~     called modafinil (ProvigilTM). There is considerable off label evidence for modafinil's~     ability to reduce fatigue related to multiple sclerosis, Parkinson's disease, cancer related~     fatigue, and depression related fatigue. There are preclinical studies showing that modafinil~     can alleviate fatigue secondary to medication side effects (diazepam, chlorpromazine). This~     multi-layered evidence base suggests that modafinil may be able to alleviate fatigue~     regardless of medical illness. Armodafinil now has four completed Phase III FDA regulatory~     studies revealing that it is well tolerated and effective for fatigue associated with~     obstructive sleep apnea (Effects of Armodafinil in the Treatment of Residual Excessive~     Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea Syndrome: A 12-Week, Multicenter,~     Double-Blind, Randomized,Placebo-Controlled Study in nCPAP-Adherent Adults. Thomas Roth et~     al. Clinical Therapeutics/Volume 28, Number 5, 2006), shift work sleep disorder, and~     narcolepsy. Armodafinil is not yet FDA approved. It is felt to be a cleaner, safer, more~     potent isomer. Theoretically, fatigue is interpreted and possibly dictated centrally and~     armodafinil's proposed mechanism (similar to that of modafinil) of elevating central~     histamine activity may allow the brain to interpret a lower fatigue state, thus allowing~     patients to function better during the day with less peripheral fatigue.~      Fibromyalgia (FM) is an illness that may involve medical, rheumatological, autoimmune, sleep,~     endocrine and psychiatric pathology. It is a syndrome of recurrent pain at trigger points.~     Greater than 90% of these patients will report fatigue as a key symptom as well. There are~     several investigation lines into the treatment of FM induced pain. Exercise, behavioral~     therapy, amitryptiline, duloxetine, tramadol, sodium oxybate all have randomized trials and~     almost all focus on pain. There are very few studies, if any, that look at FM induced fatigue~     which certainly ads to FM patients' daily incapacity and lowered productivity/quality of~     life.~      Armodafinil is a drug with minimal adverse effects (headache, insomnia, GI distress, anxiety,~     dry mouth, dizziness and an assumed low level addiction which is comparable to modafinil)~     which is well tolerated in current regulatory studies. It may have a safer tolerability~     profile than the FM medications noted above. As modafinil is often studied and often added as~     an augmentation agent to patients' regimens who suffer from fatigue in other medical~     illnesses, the authors feel that armodafinil would also be effective in this population. The~     authors wish to conduct a study to determine if armodafinil is safe and tolerable in the~     treatment of FM induced fatigue. This initial controlled study may allow for continued~     regulatory studies with this product in FM subjects. We propose a double-blind placebo~     controlled study to determine if armodafinil is safe and effective in reversing FM induced~     fatigue.~   "
220042|NCT00678678|"~     Objective: To compare the effects of the EPAP and the incentive spirometry flow-oriented in~     the pulmonary function after bariatric surgery.~      Method: Twenty-eight women, non-smokers, with no lung disease and BMI of 35-49,99 kg/m2,~     undergoing bariatric surgery by laparoscopy, were studied. Before surgery the patients were~     divided in two groups: Spirometer Group (SG) (n=13) and EPAP Group (EG) (n=15). Pulmonary~     function was evaluated by spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion,~     on the preoperative and on the second postoperative day. Physiotherapy started on the day of~     surgery, each modality (incentive spirometry or EPAP) performed lasting 15 minutes. The~     deambulation and active exercises of upper and lower limbs were standardized for groups.~   "
220043|NCT00678665|"~     Pain, a subjective sensation, has been increasingly studied, as it has been recognized as an~     important factor in patients' recovery and quality of life. Pain is charted today as one of~     the vital signs. For standardization, pain is charted by a number from 0 to 10 indicating its~     level. The most common practiced pain assessment tool today is the VAS- Visual Analog Score~     (facial or numerical), by which the patient himself indicates the level of the pain he or she~     endures. It has been found that the correlation between the reported pain by the patient and~     the assessed pain by the caregivers or the medical personnel becomes poor as pain~     intensifies.~      Objective assessment of anesthesia using the heart rate and its spectral analyses was done in~     the past. By using this modality, works on neonatal pain were conducted. In adults, works~     have shown that there is possibility to assess pain using this modality, though no repeated~     proof for its ability to detect pain was published.~      We know that physiological signals such as ECG consist of mixtures of variety of patterns and~     phenomena accruing at different patterns and time points. Traditional analysis methods are~     designed and optimized to handle signals that include a single class of patterns such as pure~     harmonics or piece-wise constant functions. However, such basic operations that use a single~     representation method usually yield mediocre results when applied to real complex biological~     signals as ECG and EEG especially in the case where the Signal to Noise Ratio (SNR) is very~     low. Recent trends in digital signal processing (DSP) use the novel idea of merging several~     different representation methods to create a so called over-complete dictionary, examples of~     this approach include the Matching Pursuit algorithm and the Basis Pursuit algorithm. We~     intend to develop and apply the novel signal processing tools to the ECG signals for the~     first time. We believe that such tools have the potential to provide much better insight of~     the signal basic components and their relation to pain.~   "
220044|NCT00678652|"~     The purpose of this study is to determine whether a vaccine based on outer membrane vesicles~     (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a~     vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other~     genetically modified strains as a potentially globally effective vaccine against group B~     meningococcus.~   "
220045|NCT00678639|"~     The purpose of this study is to investigate the best way to evaluate patients with chest pain~     in the emergency department. It compares receiving treatment in an observation unit with~     admission to the hospital. Patients treated in the observation unit will undergo cardiac~     Magnetic Resonance Imaging (MRI) testing. Patients treated with hospital admission will~     undergo the testing their doctor determines is best for them. All patients will undergo~     follow up to find out if they have had any heart related events.~   "
220046|NCT00678626|"~     This study will assess the effectiveness of CP- 751,871 when given in combination with~     docetaxel to women with the first occurrence of advanced breast cancer disease. The~     effectiveness will be measured by progression-free survival duration. Patients will be~     followed for 2 years from the date of randomization.~   "
220047|NCT00678613|"~     Cirrhotic patients are predisposed to bacterial infection. A large proportion of which is~     spontaneous bacterial peritonitis(SBP), which are mainly caused by enteric bacteria.SBP in a~     cirrhotic patients is associated with a high mortality rate in the order of 30-80% per~     year.It has been demonstrated that cirrhotics who have an ascitic fluid protein concentration~     less than 1gm% are most susceptible to develop SBP by virtue of having low opsonising~     activity of ascitic fluid.Patients with liver cirrhosis have significant degrees of imbalance~     of intestinal flora.Translocation of intestinal bacteria being the major mechanism for the~     production of SBP.~      Long-term antibiotic (norfloxacin) is very effective in preventing SBP caused by gram~     negative bacteria.But the problem with the long-term antibiotic prophylaxis is the potential~     for the development of infection with antibiotic-resistant bacteria.Further, quinolones have~     no effect on gram positive bacteria which is becoming one of the important cause of SBP.~      Such experiences necessitate the need for strategies, other than antibiotic, to prevent~     intestinal bacterial overgrowth, bacterial translocation and SBP in patients with~     cirrhosis.Probiotics have been used successfully to alter the gut flora in many clinical~     conditions where growth and localization of non pathogenic bacteria replaces the pathogenic~     bacteria in the intestine.The probiotic bacteria, among which the most common are the lactose~     fermenting Lactobacilli, inhibit the growth of pathogenic bacteria by acidifying the gut~     lumen, competing for nutrients, and by producing antimicrobial substances. They adhere to the~     gut mucosa and by that are thought to prevent bacterial translocation from the gut.~      The purpose of this study is to determine the effectiveness of probiotics in the prevention~     of spontaneous bacterial peritonitis in patients with cirrhosis with low protein ascites and~     those already have developed an episode SBP.~   "
220048|NCT00678600|"~     The purpose of this study is to determine whether alerts independent of the ambulatory health~     record are more effective in eliciting physician responses and therefore have greater impact~     on HIV disease outcomes than traditional static alerts.~   "
220073|NCT00678275|"~     This multicenter, prospective phase III-study is to compare the administration of ATG~     FRESENIUS to the NON-administration of ATG FRESENIUS in a myeloablative conditioning regimen~     followed by allogeneic hematopoeitic stem cell transplantation from an HLA-identical sibling~     in patients with acute Leukemia. This clinical trial is to show that the administration of~     ATG FRESENIUS reduces the risk of chronic Graft-versus-Host disease after allogeneic stem~     cell transplantation from HLA-identical siblings.~   "
220049|NCT00678587|"~     The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts~     thereby reducing the need for platelet transfusions in chronic liver disease patients with~     thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag~     will be measured by the proportion of subjects who avoid platelet transfusions, before,~     during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events~     will be monitored during this time. The number of transfusions, safety events and medical~     resource utilisation will be monitored during this time and for up to 30 days after~     undergoing an invasive procedure to help further evaluate clinical benefit.~   "
220050|NCT00678574|"~     The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the~     pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring~     cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance~     spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and~     post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®,~     Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid~     levels with cortical GABA levels at these same time points. Neurosteroids to be measured~     include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with~     PMDD will be compared to those of healthy subjects.~   "
220051|NCT00678561|"~     Study will test effectiveness of an experimental drug applied once or twice daily to two~     psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.~   "
220052|NCT00678548|"~     Chronic pain after spinal cord injury in or below the level of injury is a common problem and~     can be severe.~      The purpose of our study is to investigate the effect of pleasant guided imagery on spinal~     cord injured patients with chronic pain in or below the level of injury.~   "
220053|NCT00678535|"~     The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line~     treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a~     clinically relevant benefit for subjects with advanced gastric adenocarcinoma including~     gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).~      Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall~     survival, overall tumor response, quality of life (QoL) and safety.~   "
220054|NCT00678522|"~     We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium~     excretion, glomerular filtration rate, tubular function and vasoactive hormones in patients~     with type II diabetes, not in treatment with insulin.~   "
220055|NCT00678509|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402~     restricted epitope peptide TTK emulsified with Montanide ISA 51.~   "
220056|NCT00678496|"~     Guidance issued by the UK National Institute for Health and Clinical Excellence (NICE)~     recommends the use of computerised cognitive behavioural therapy (CCBT) 'Beating the Blues'~     (BtB) in treatment of depression. However CCBT has not been designed specifically for use by~     people with Multiple Sclerosis (MS) and may not be effective or appropriate for use by people~     with physical disabilities or cognitive symptoms. There would therefore be value in~     conducting a trial of the effectiveness of CCBT for depression in people with MS. The aim of~     this pilot study is to test the feasibility of a randomised control trial (RCT) of CCBT for~     depression in people with MS. The objective is to undertake a pilot RCT of comparison of CCBT~     with usual care including 3 month follow up to identify a realistic patient recruitment rate~     and provide reliable estimates of other parameters needed for designing a definitive RCT~     including the sample size. Other outcomes to be measured include estimates of the effect on~     depression and quality of life. Participants will be assessed as experiencing clinical levels~     of depression and be recruited from two participating MS Centres. The outcomes of the study~     will be (1) preliminary indication of the impact of CCBT on depression in MS; and, (2) a well~     researched protocol for a definitive RCT of the effectiveness of CCBT in treating depression~     in people with MS.~   "
220057|NCT00678483|"~     The primary objective of this study is to assess, over a period of 12 months, the effect on~     weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in~     overweight/obese patients after an initial treatment period of 6 months with rimonabant 20~     mg.~      Secondary objectives are to assess the effect of rimonabant over a period of 12 months on~     waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG),~     fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and~     tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in~     overweight/obese patients.~   "
220058|NCT00678470|"~     This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in~     this 6 month study to evaluate whether the response to intralesional alefacept injections~     prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes~     in psoriasis patients. One lesion with a psoriasis severity assessment score greater than 3~     and an induration score greater than 1 will be identified on each patient. Each lesion will~     receive only one intralesional alefacept injection during the first three weeks of the study~     (1 lesion per week). Following a 2 week observation period, subjects will undergo a standard~     12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity~     Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept~     treatments. An 8 week follow-up period will begin after the last dose of alefacept is~     administered where safety and efficacy measures will continue to be monitored as outlined in~     the study procedures. The hypothesis is that the response to intralesional alefacept~     injections, whether it is positive or no benefit, will predict the clinical response to~     intramuscular alefacept administration.~   "
220059|NCT00678457|"~     This study would like to test whether the combination of ondansetron and olanzapine will be~     superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.~   "
220060|NCT00678444|"~     To compare patient satisfaction and anxiety scores between female subjects undergoing urinary~     incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the~     technique of clean intermittent self-catheterization (CISC) by means of an instructional~     video and those who do not receive specific preoperative instruction in CISC, other than~     basic informed consent regarding risks of postoperative urinary retention.~   "
220097|NCT00677950|"~     The trial was designed to demonstrate the comparability of the overall success rate in the~     OP-1 Putty treatment group to the autograft treatment group.~   "
220061|NCT00678431|"~     Alzheimer's disease (AD), one of the leading causes of morbidity and mortality in the elderly~     is characterized by progressive cognitive decline and certain neuropathological features.~      Currently, there is great interest in the well-documented mitochondrial (oxidative) lesion in~     AD. Disturbed oxidative metabolism is a well described abnormality in AD. Several~     observational studies have shown that moderate consumption of wine is associated with a lower~     incidence of Alzheimer's disease (Truelsen et al., 2002; Luchsinger et al., 2004). Wine is~     enriched in antioxidant compounds with potential neuroprotective activities. In the early~     1990s the presence of Resveratrol in red wine was detected where it is suspected to afford~     antioxidant and neuroprotective properties (Miller and Rice-Evans, 1995).~      Blass and Gordon (2004) have demonstrated positive effects in AD with an oral preparation of~     glucose, malate and resveratrol. Glucose is the physiological precursor of the substrates of~     oxidative metabolism in the brain, malate is a primer of the energy-providing Krebs-cycle.~     Glucose and malate therefore can provide reducing equivalents (electrons) to regenerate the~     reduced form of resveratrol, and do so under the normal regulation of brain cell metabolism.~     All three ingredients are classified by the FDA as Generally Recognized As Safe.~   "
220062|NCT00678418|"~     This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of~     VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon~     discharge from inpatient treatment for opioid dependence.~      The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has~     completed. Results for Part B are not yet available.~   "
220063|NCT00678405|"~     The aim of this study is to evaluate the impact of a Breathlessness Intervention Service~     (BIS) on the quality of life of patients and families affected by intractable breathlessness.~     The questions to be addressed by this research are:~        1. Is BIS more effective than standard care for patients with intractable breathlessness~          from advanced malignant or non-malignant disease?~        2. Does it reduce patient and carer distress due to breathlessness, and increase patients'~          sense of mastery of the symptom?~        3. What are the experiences and views of those who use BIS, their informal carers and the~          clinicians who refer to it?~        4. Does BIS offer value for money for the NHS?~   "
220064|NCT00678392|"~     The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in~     delaying tumor progression in patients with metastatic renal cell cancer after failure of one~     first line regimen.~   "
220065|NCT00678379|"~     Tonsillectomy is associated with a significant decrease quality of life in children secondary~     to pain, which is worsened with swallowing. The objective of the current study is to conduct~     a prospective, double-blind, placebo-controlled, randomized clinical trial using a~     pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in~     reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline~     injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) +~     clonidine (25 µg).~   "
220066|NCT00678366|"~     The study intends to investigate the use of a novel gaz-composition used during laparoscopy~     upon pain and inflammation in the post-operative period.~   "
220067|NCT00678353|"~     This study is to provide additional data to support the safety and efficacy of OP-1 Putty as~     a replacement for autograft in patients undergoing posterolateral spinal fusion.~   "
220068|NCT00678340|"~     Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF~     occurs in up to 10% of the population over the age of 60. It is associated with tiredness,~     impaired functional capacity and is the cause of up to 10% of strokes.~      Ablation is a procedure performed with small tubes (catheters) that are introduced through~     the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been~     shown to cure 90% of patients with intermittent (paroxysmal) AF.~      The investigators currently use either one of two different catheters to create these burns~     inside the heart. The investigators do not know which is the best catheter to use in patients~     with paroxysmal atrial fibrillation.~      The investigators study will randomly allocate patients to have their ablation performed by~     either one of the catheters to give a fair comparison between the two. The investigators~     objective is to study the differences between these two catheters.~   "
220069|NCT00678327|"~     RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before,~     during, and after chemotherapy may help doctors assess a patient's response to treatment and~     help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in~     assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.~      PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it~     works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage~     III, or stage IV Hodgkin lymphoma.~   "
220070|NCT00678314|"~     This study was done with the primary aim of assessing the efficacy (as calculated by pain~     intensity difference) of patient controlled regional analgesia (PCRA) technique against oral~     analgesics, which has been the standard of care at our hospital. Secondary objectives were to~     analyze the volume and dose of LA that should be given, patient satisfaction and the~     long-term outcome for patients treated with the PCRA technique.~   "
220071|NCT00678301|"~     The purpose of this study is to assess the immunogenicity in terms of antibody response and~     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse~     events following primary vaccination of African Sub-Saharan infants with pneumococcal~     conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell~     pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4~     months of life.~   "
220072|NCT00678288|"~     This study is to assess sorafenib as second treatment for patients that have previously~     received only sunitinib as first-line treatment for advanced renal cell cancer, and who~     either responded and then progressed with sunitinib or were intolerant to sunitinib. This~     study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose~     interferon (3 million international unit (MIU) five times a week) can treat kidney cancer~     more effectively than the current approved dose alone and if it is safe. In addition, for~     patients that respond to treatment with sorafenib alone or in combination with interferon~     before progressing, patients may receive sorafenib alone at an increased dose of 300mg~     twice-daily, provided that toxicities are acceptable and at the discretion of the~     investigator.~   "
220074|NCT00678262|"~     Abstract:~      Pain, a subjective sensation, has been increasingly studied, as it has been recognized as an~     important factor in patients' recovery and quality of life. Pain is charted today as one of~     the vital signs. For standardization, pain is charted by a number from 0 to 10 indicating its~     level. The most common practiced pain assessment tool today is the VAS- Visual Analog Score~     (facial or numerical), by which the patient himself indicates the level of the pain he or she~     endures. It has been found that the correlation between the reported pain by the patient and~     the assessed pain by the caregivers or the medical personnel becomes poor as pain~     intensifies.~      Objective assessment of anesthesia using the heart rate and its spectral analyses was done in~     the past. By using this modality, works on neonatal pain were conducted. In adults, works~     have shown that there is possibility to assess pain using this modality, though no repeated~     proof for its ability to detect pain was published.~      We know that physiological signals such as ECG consist of mixtures of variety of patterns and~     phenomena accruing at different patterns and time points. Traditional analysis methods are~     designed and optimized to handle signals that include a single class of patterns such as pure~     harmonics or piece-wise constant functions. However, such basic operations that use a single~     representation method usually yield mediocre results when applied to real complex biological~     signals as ECG and EEG especially in the case where the Signal to Noise Ratio (SNR) is very~     low. Recent trends in digital signal processing (DSP) use the novel idea of merging several~     different representation methods to create a so called over-complete dictionary, examples of~     this approach include the Matching Pursuit algorithm and the Basis Pursuit algorithm. We~     intend to develop and apply the novel signal processing tools to the ECG signals during~     painful experience for the first time. We believe that such tools have the potential to~     provide much better insight of the signal basic components and their relation to pain.~   "
220075|NCT00678249|"~     This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients~     with stenoses at the venous anastomosis of a synthetic AV access graft.~   "
220076|NCT00678236|"~     The goal of this scientific study is to determine whether there are differences in early~     migration and prosthesis-near bone density when a standard knee prosthesis is fixed with~     Refobacin Bone Cement R or with Refobacin Plus Bone Cement. Migration will be evaluated with~     RSA and bone density around the prosthesis with DEXA. The study will be successful if the~     prosthesis is fixed and remains in place throughout the entire period of the study, that is,~     that there is no increasing migration as measured by RSA. The cement type that ensures the~     largest number of solidly fixed prostheses during the two-year evaluation period will be the~     best.~   "
220077|NCT00678210|"~     The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3~     dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic~     plaque psoriasis.~   "
220078|NCT00678197|"~     The long-term consequences of poverty on child health, including cognitive development, are~     one of the world's great tragedies. In the Philippines, diarrhea, acute lower respiratory~     infections, and the attendant problems of malnutrition, are the leading causes of childhood~     illness. The Philippine government plans to launch a broad national Health Sector Reform~     Agenda (HSRA) that will address the problems of poverty and illness in children. The~     introduction of these reforms provides an exceptional opportunity to conduct a social~     experiment. Four institutions, already involved in the design and implementation of the HSRA,~     plus leading experts in international health, government, and health measurement will~     collaborate on this project to collect longitudinal data and measure the impact of HSRA~     reforms on child health outcomes in a population. We will measure the health impacts of two~     experimental interventions: (1) expansion of health insurance coverage, and (2) capitation of~     providers. Our research will measure the impact of health reforms on the physical and~     cognitive health outcomes of children age 0-4. We will use a block design of 21 sites~     throughout the Philippines: seven for each of the two interventions, and seven matched~     controls. We will measure the quality of clinical practice using vignettes and will measure~     health outcomes using objective clinical tests. We will also use an advanced sampling~     strategy and panel data to link clinical practice with population health outcomes. This~     unparalleled research opportunity will yield significant insights about specific, unanswered~     questions of tremendous importance: Does health care serve as a social intervention that~     ameliorates the effects of morbidity and malnutrition on cognitive development? How effective~     are government policies at creating incentives to improve the quality of clinical practice?~     Do financial and organizational policies actually lead to better health and developmental~     outcomes? The results from this study will provide insights into the linkages between~     increased access, high quality care, and health outcomes in children.~   "
220079|NCT00678184|"~     We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium~     handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans~     during normal and high sodium intake.~   "
220080|NCT00678171|"~     This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of~     single-level TLIF of the lumbar spine.~   "
220081|NCT00678158|"~     The purpose of this research study is to find out what IG-IMRT radiation dose works best for~     treatment of disease in bone or soft tissues. This protocol will study what dose level may~     work most effectively. The first part of study will treat 10 patients with 22 Gray. Gray (Gy)~     is the unit that is used to describe the dose of radiation that is being given to a person~     with cancer. After we confirm that 22 Gy is a safe and sufficient amount of radiation, we~     will then treat another group of patients with 24 Gy and so on until we reach 28 Gy. Each~     dose level starting with 24 Gy will enroll at least 20 patients per treatment site (bone,~     bowel and/or spine). Patients will be enrolled in each treatment category until 20 patients~     in each strata reach an evaluable time point of 3 months post-RT. When we understand what~     dose works best and has the least amount of bad effects, the study will then look to see how~     well the patients do after the radiation therapy. This study is trying to see how your doctor~     can best treat the cancer that has spread to the other parts of your body.~   "
220082|NCT00678145|"~     Intensive glucose control in type 1 diabetes mellitus (T1DM) is associated with clear health~     benefits (1). However, despite development of insulin analogs, pump/multi-dose treatment and~     continuous glucose monitoring, maintaining near-normal glycemia remains an elusive goal for~     most patients, in large part owing to the risk of hypoglycemia. T1DM patients are susceptible~     to hypoglycemia due to defective counterregulatory responses (CR) characterized by: 1)~     deficient glucagon release during impending/early hypoglycemia; 2) additional~     hypoglycemia-associated autonomic failure (HAAF) and exercise-associated autonomic failure~     (EAAF) that blunt the sympathoadrenal responses to hypoglycemia following repeated episodes~     of hypoglycemia or exercise as well as degrading other CR; and 3) hypoglycemia unawareness~     (HU), lowering the threshold for symptoms that trigger behavioral responses (e.g. eating).~     Thus, the risk of hypoglycemia in T1DM impedes ideal insulin treatment and leads to~     defaulting to suboptimal glycemic control (2). There are two approaches that could resolve~     this important clinical problem: 1) perfection of glucose sensing and insulin and glucagon~     delivery approaches (bioengineered or cell-based) that mimic normal islet function and~     precisely regulate glucose continuously, or 2) a drug to enhance or normalize the pattern of~     CR to hypoglycemia. Despite much research and important advances in the field, neither islet~     transplantation nor biosensor devices have emerged as viable long-term solutions for the~     majority of patients (3, 4). Over the past several years, our lab has explored the approach~     of enhancing CR by examining mechanisms responsible for HAAF/EAAF and searching for potential~     pharmacological methods to modulate the CR to hypoglycemia (5-11). Our work has led to a~     paradigm shift in the field of hypoglycemia, exemplified by the novel hypothesis and~     published experimental data supporting a role for opioid signaling that resulted in the~     initiation of exploratory clinical trials by other research groups.~   "
220108|NCT00677807|"~     This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against~     placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients~   "
220140|NCT00677391|"~     The primary objective of this study was to evaluate the efficacy and the safety of~     sibutramine vs. placebo in combination with a hypocaloric diet on weight-loss in overweight~     and obese Malaysian subjects.~   "
220083|NCT00678132|"~     Background:~        -  AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a~          protein that is involved in repairing DNA damage; PARP inhibitors interfere with that~          process.~        -  Cisplatin and gemcitabine are approved by the United States Food and Drug Administration~          to treat certain cancers.~      Objectives:~        -  To determine the optimum doses of AZD2281, cisplatin and gemcitabine in combination that~          can safely be given to patients with solid tumor cancers.~        -  To evaluate the response of the tumor to the drug combination and determine the side~          effects of the treatment.~      Eligibility:~      -Patients 18 years or older with an advanced solid tumor cancer for whom standard treatments~     are not effective.~      Design:~        -  In this dose escalation study, the first small group of patients receives the smallest~          study doses of the study drugs. Subsequent groups receive incrementally higher doses as~          long as the preceding group does not experience unacceptable side effects. When the~          highest safe dose is determined, additional patients entering the study receive that~          dose.~        -  Patients receive treatment in 21-day cycles as follows:~        -  Days 1-4: AZD2281 by mouth twice a day~        -  Day 3: gemcitabine thorough a vein over 1 hour; then cisplatin through a vein over 1~          hour.~        -  Day 10: gemcitabine through a vein over 1 hour.~        -  Evaluations during treatment include the following:~        -  Physical examination, vital signs check and blood tests every 3 weeks.~        -  CT scans every 6 weeks to evaluate the tumor.~        -  Treatment may continue until it is no longer beneficial.~   "
220084|NCT00678119|"~     Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in~     combination with sunitinib in subjects with previously untreated advanced stage RCC.~   "
220085|NCT00678106|"~     Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1~     gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be~     measured at different time points. Safety labs will also be checked on a regular basis to~     assess the safety of dalbavancin.~   "
220086|NCT00678093|"~     Mulligan's mobilisation techniques are believed to increase the range of movement (ROM) in~     patients with low back pain. The primary aim of this study was to investigate the mechanical~     effects of Mulligan's SNAG technique on lumbar flexion ROM. The secondary aim was to~     measure the intra- and inter-day reliability of lumbar ROM employing the same procedure, and~     utilising a 3-D motion analysis system for measuring range of motion (ROM).~   "
220087|NCT00678080|"~     Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages,~     birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range~     decreases these pregnancy complications. We hypothesize that metformin will achieve similar~     levels of blood sugar control compared to insulin. In doing so, metformin will prevent the~     increased risk of pregnancy complications associated with T2DM in pregnancy. We propose a~     pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of~     T2DM during pregnancy.~   "
220088|NCT00678067|"~     To examine whether Docosahexaenoic Acid (DHA) and Docosahexaenoic + Eicosapentaenoic Acids~     (DHA+EPA) supplementation in addition to National Cholesterol Education Program Step I Diet~     in Hypercholesterolemic Children increases Docosahexaenoic Acid (DHA) plasma levels in the 2~     intervention groups versus placebo. Secondary outcome measure: effect of DHA and DHA+EPA~     supplementation on blood lipid profile~   "
220089|NCT00678054|"~     This is a Phase II study to test the efficacy of exogenously administered GM-CSF in prostate~     cancer patients who have failed definitive local therapy, and have only serologic (PSA)~     evidence of progression.~   "
220090|NCT00678041|"~     Urinary tract infection (UTI) is the most common complication after surgery for prolapse or~     urinary incontinence. UTIs are painful and have the potential to turn into kidney infections.~     We are asking women who self-catheterize after surgery to try either an antibiotic or a~     placebo pill so we can see if we can prevent UTIs without causing side effects.~      This study will not require any additional visits or blood draws. You will be asked to answer~     some questions, keep a brief diary of your experience, and immediately report any symptoms of~     a UTI to your doctor.~   "
220091|NCT00678028|"~     Due to genetic polymorphism about 15%-30% of the world population have low levels of MBL~     (Mannose Binding Lectin) in serum (below 500ng/mL). Different studies reported correlation~     between polymorphism in the MBL gene with low levels of MBL in serum and higher frequency of~     recurrent infections, severity of sepsis, ARDS and other infections. Urinary Tract Infection~     (UTI) is one of the very common infection in women. Since MBL is part of the innate immunity~     and there are proofs of relation between patients with recurrent infections and lack of MBL,~     we decided to explore a possible relation between low levels of MBL and different genotypes~     of MBL in young women and the risk to develop recurrent UTI.~   "
220092|NCT00678015|"~     This is a Phase II, single center study measuring the pharmacokinetic parameters of NDGA~     administration and assessing the proportion of patients who experience a 50% decline in PSA.~   "
220093|NCT00678002|"~     The goal of this study is to compare parent and child perceptions of wellness and~     vulnerability in children who have undergone solid organ transplant. It is hypothesized that~     there will be significant differences between parent and child perceptions.~   "
220094|NCT00677989|"~     The purpose of this study is to conduct a prospective observational study for the open~     approach and laparoscopic approach for perforated appendicitis. It is also designed to~     investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating~     perforated appendicitis with laparoscopic operation.~   "
220095|NCT00677976|"~     The purpose of the study is to map regions of brain activation following rectal stimulation~     in children with irritable bowel syndrome (IBS) and healthy controls.~   "
220096|NCT00677963|"~     The first goal of this study is to investigate whether CE-US is able to accurately identify~     and quantify neovascularisation in carotid artery plaques. Since this is one of the first~     studies systematically evaluating the ability of ultrasound in combination with air bubbles~     to evaluate neovascularisation in carotid artery plaques, the examination will be performed~     twice with an interval of 1/2 hour on the day before surgery, thus studying the reliability~     of the method.~      The second goal of this study is to investigate whether MRI at 3.0 T with a custom-designed~     3T carotid coil, using a recently developed pulse sequence, is able to accurately identify~     and quantify neovascularisation. And the third goal of this study is to make an intermodality~     comparison of CE-US and MRI regarding their ability to identify and quantify plaque~     neovascularisation.~   "
220098|NCT00677937|"~     The study aims to identify people at high diabetes risk within the local population and then~     implement and evaluate a pragmatic and low-cost diabetes prevention programme containing~     structured education on lifestyle, physical activity and food choices. An ongoing support~     framework will continue to reinforce and maintain the participant's individual goals to~     prevent the development of diabetes and reduce cardiovascular risk.~      Therefore the principal question is: can we significantly reduce the incidence of diabetes~     through structured education in a high risk multi-ethnic UK population?~   "
220099|NCT00677924|"~     The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in~     combination with Irinotecan for the treatment of patients with Colorectal Cancer~   "
220100|NCT00677911|"~     Principal Investigator/Program Director (Last, First, Middle): Darnall, Beth APS Future~     Leaders in Pain Small Research Grants Application Page 5 Continuation Format Page~      Summary: Chronic pain is stressful, both physically and psychologically. Stressful~     experiences induce autonomic nervous system arousal, which reliably leads to inflammation and~     immune suppression. Inflammation then exacerbates existing pain and may be a key factor in~     both the genesis and maintenance of pain. Stress-induced immune effects are detected two~     hours (2 hrs) post-stressor, suggesting only a few stressful experiences per day may be~     sufficient to sustain elevated pain levels1. Cognition has emerged as a potential mediating~     factor in the relationship between pain and stress. Mentally recreating an emotionally~     stressful event induces de novo physiological stress1. In other words, thinking about an~     emotionally charged event down-regulates autonomic stress responses and subsequent immune~     effects. Therefore, exploring cognition as a mediating factor between stress, pain, and~     inflammation will inform our understanding of pain pathways, as well as improve treatment for~     pain.~      Study Rationale: The acute stress response induces immunosuppression; however, this~     relationship has been studied in arbitrary models only (shock avoidance, job interview). This~     study employs the novel approach of examining stress and immune responses to a personally~     relevant stressor (pain); prior studies used arbitrary models only (shock avoidance, job~     interview). Pain offers a highly salient and personal context well-suited for investigation~     of negative cognitive perseveration. Pain is acutely sensitive to exacerbation via~     inflammation, and thus the relevance of examining immune effects of rumination on future~     negative expectations (expecting the worst) is underscored.~      Goal: To test the biological consequences of negative expectations, achieved via an active~     10-minute negative cognitive perseveration on a personally relevant stressor: future~     worsening of one's chronic pain condition. Biological stress response will be measured via~     heart rate (HR), blood pressure (BP) and serum cortisol. Impact of negative cognition on~     inflammation will be measured using interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor~     necrosis factor-alpha (TNF-α) as biomarkers of immune function, controlling for depression~     and pain catastrophizing. This study aims to inform the understanding of pain mechanisms.~      Aim 1: Determine the magnitude of an autonomic stress response to an induction of negative~     cognition.~      Aim 2: Determine immune effects of the experiment-induced stress response.~      Aim 3: Establish whether a pre-existing tendency to catastrophize mediates the relationship~     between experiment-induced negative perseveration and immune effects.~      Aim 4: Establish whether stress-related increases in IL-6 remain elevated post 2 hrs.~   "
220101|NCT00677898|"~     The purpose of this study is to determine if individuals with serious mental illnesses~     exposed to a patient-centered computerized tool versus printed educational materials have~     higher rates of screening for the metabolic side effects of second-generation antipsychotic~     medications and different patterns of communication with their prescribers about screening.~   "
220102|NCT00677885|"~     This study will measure the function of a protein called P-glycoprotein (P-gp), which is~     found at the blood-brain barrier, a membrane that normally prevents toxic material from~     entering the brain. Impaired P-gp function may allow toxins to enter the brain and cause some~     people to develop certain brain diseases.~      Healthy subjects and people with Alzheimer s disease, Parkinson s disease or frontotemporal~     dementia who are 35 years of age or older and in overall good health may be eligible for this~     study.~      Participants undergo the following procedures during three outpatient visits to the NIH~     Clinical Center:~        -  Medical history, psychological evaluation, physical examination and blood and urine~          tests, including tests for illegal and addictive drugs.~        -  PET scan: This test uses small amounts of a radioactive chemical called a tracer that~          labels active areas of the brain so the activity can be seen with a special camera.~          Before starting the scan, a catheter (plastic tube) is placed in a vein in the arm to~          inject the tracer. The subject lies on the scanner bed, with a special mask fitted to~          the head and attached to the bed to help keep the head still during the scan so the~          images obtained are clear. A brief initial scan is done to calibrate the scanner. Then,~          a radioactive tracer called [(15)O]H(2)O is injected into the catheter and the PET~          camera takes pictures of blood flow to the brain for about 60 seconds. Next, another~          tracer, [(11)C]dLop, is injected into the catheter and pictures are taken for about 2~          hours to determine how much of this tracer is allowed to enter the brain.~        -  Magnetic resonance imaging (MRI): This procedure is done within 1 year (before or after)~          the PET scan. MRI uses a magnetic field and radio waves to produce images of the brain.~          For this procedure, the patient lies on a table that can slide in and out of the scanner~          (a tube-like device), wearing earplugs to muffle loud knocking and thumping sounds that~          occur during the scan.~   "
220103|NCT00677872|"~     A 3-month open label study to evaluate the safety and efficacy of PRX-08066 in patients with~     pulmonary hypertension and COPD.~   "
220104|NCT00677859|"~     The purpose of this study is to determine if MultiStem® can safely be given to patients with~     acute leukemia, chronic myeloid leukemia, or myelodysplasia after they have received~     hematopoietic stem cell transplantation.~   "
220105|NCT00677846|"~     Background:~      During the repair process of deep venous thrombosis, capillary formation is seen from day 18~     to day 25. Contrast agent investigation is well known to detect small vessels in arterial~     disease. We intend to use this method to detect early vascularisation in the thrombus, in~     order to get more information about the evolution of the thrombosis in vivo.~      Aims of the study:~      Investigation of a newly diagnosed occluding venous thrombus with duplexsonography, using~     contrast agent and compare the degree of vascularization in the same patient after 3 weeks~     and 3 months. The relative signal intensity difference (baseline to peak) of the time~     intensity curve (TIC) is measured in defined region of interests (ROI). Comparison of the~     visibility of revascularisation between color duplexsonography, power mode and contrast agent~     will be done.~      Method:~      Patients with venous thrombosis of the proximal limb veins (femoral or popliteal vein) will~     be investigated with ultrasound agent in supine position. 5 ml of the contrast agent sulfur~     hexafluoride is given intravenously into a vein of the dorsal foot. The measurements are done~     in a defined area, where the thrombus is fully occluding in color Doppler investigation. The~     regions of interest will be the vessel walls and the centre of the thrombus in cross section~     view. The signal intensities are measured at baseline and peak (in decibel) in the centre and~     in the peripheral part of the vein. 20 patients with acute deep venous thrombosis will be~     included in this pilot study and investigated at baseline, after 3 weeks and 3 months.~      Previously (before contrast agent application), the veins are investigated with color - and~     power Doppler to test visibility in comparison to the contrast agent investigation.~   "
220106|NCT00677833|"~     The primary objective is to confirm the hypothesis that azithromycin used in combination with~     chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic,~     uncomplicated malaria due to P. falciparum in children in African countries.~   "
220107|NCT00677820|"~     This prospective annual release study was designed to assess the safety of a trivalent~     influenza virus vaccine using a new strain recommended for the 2008-2009 influenza season not~     previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy~     adults received a single dose of vaccine or placebo and were followed for 180 days.~   "
220110|NCT00677781|"~     Microparticles are cellular fragments which are released actively or passively under~     conditions of inflammation and stress. The impact of surgical operations on quantity and~     quality of microparticles remains unknown. In this observatory study we investigate~     quantitative and qualitative aspects of microparticles during cardiac and abdominal~     operations.~   "
220111|NCT00677768|"~     The purpose of this study is to collect 650 blood and 300 cerebrospinal fluid (CSF) samples~     from people with amyotrophic lateral sclerosis (ALS), pure lower or upper motor neuron~     diseases, as well as other neurodegenerative diseases and from people with no neurological~     disorder. Through comparison of these samples, the researchers hope to learn more about the~     underlying cause of ALS, as well as find unique biological markers, which could be used to~     diagnose ALS and monitor disease progression.~      Additionally, up to 600 blood samples will be collected for a sub-study for DNA analysis.~     Studying components of the blood, such as DNA, may help us understand what happens when genes~     function abnormally and how it might be related to disease.~   "
220112|NCT00677755|"~     The purpose of this study is to compare the efficacy, safety and acceptability of~     pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical~     termination of pregnancy by mifepristone EC failure.~   "
220113|NCT00677742|"~     The purpose of this study is to determine whether getting more packs of birth control pills~     leads to improved continuation, when compared with getting the traditional supply.~   "
220114|NCT00677729|"~     Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to~     hospital with viral bronchiolitis has been shown to improve airway clearance and reduces~     length of stay.~      Hypothesis: When infants first present to the ER, frequent administration of HS over a brief~     time period will provide significant symptom improvement such that the need for hospital~     admission will be reduced.~      Objective: To determine in a randomized, controlled and double-blind fashion if the short~     term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce~     the rate of hospital admission for infants presenting with moderately severe viral~     bronchiolitis.~   "
220115|NCT00677716|"~     Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a~     targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and~     deliver radiation directly to the center of the tumor mass while minimizing effects on normal~     tissues. Cotara® thus literally destroys the tumor from the inside out. This may be an~     effective treatment for glioblastoma multiforme, a malignant type of brain cancer.~   "
220116|NCT00677703|"~     Teen girls and young women taking birth control pills may forget to take their pills or may~     stop taking them altogether. This places them at risk for unintended pregnancies. Most young~     women own cell phones and use them for text messaging. We will test whether contraceptive~     continuation is affected after six months of daily text message reminders.~   "
220117|NCT00677690|"~     The purpose of this study is to elucidate whether combination of usual pulmonary~     rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise~     capacity in patients affected by chronic obstructive pulmonary disease (COPD).~   "
220118|NCT00677677|"~     Human papillomavirus (HPV) affects a significant number of transplant patients. In women,~     human papillomavirus (HPV) causes genital warts, pre-cancerous areas of the cervix, and~     cervical cancer. In men, the virus can cause warts of the anal and genital areas. Men can~     also sexually transmit the virus to their partners. A patient who has had an organ transplant~     is at higher risk of infections as well as cancers because of the lifelong immune suppressive~     medications. HPV vaccination is effective in the prevention of cervical cancer and is now~     recommended for all females aged 9-26 years by Alberta Health and Wellness and the Canadian~     National Advisory Committee on Immunization (NACI). However, how well the vaccine works in~     transplant patients is not known.~      This study is being done to look at response of the immune system to HPV vaccine in men and~     women up to the age of 35 who have had an organ transplant. Men are also included in this~     study because they have the potential to get anal / genital warts and transmit the virus to~     their partners. The total duration of the study is three years. Fifty female and male solid~     organ transplant recipients (lung, heart, liver, kidney, pancreas, small bowel or combined~     organ transplants) on immunosuppression will be enrolled in the study.~   "
220119|NCT00677664|"~     The purpose of this study is to evaluate the effects of Copaxone injections in retinal~     function and integrity in diabetic patients who underwent pan-retinal photocoagulation.~   "
220120|NCT00677651|"~     This project was created to assess sex differences in adipose tissue gene expression in~     different locations in the body. The primary objectives are to understand:~        1. The mechanisms of differential body fat distribution in men and women~        2. How body fat distribution is affected by reproductive hormones~        3. The mechanisms linking fat distribution to health risks such as diabetes~   "
220121|NCT00677638|"~     A prospective single arm study evaluating feasibility and safety of a catheter-based~     transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with~     severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for~     standard surgical valve replacement.~   "
220122|NCT00677625|"~     The purpose of this study is to collect data to examine and characterize the clinical~     outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of~     Wisconsin.~   "
220123|NCT00677612|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201~     restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination~     with Tegafur/Uracil/Folinate chemotherapy.~   "
220124|NCT00677599|"~     The purpose of this placebo controlled trial is to determine whether a year long intervention~     with flavonoids (found in cocoa and soy) is more effective in reducing the risk of~     cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy~     (statins). A range of markers of cardiovascular disease risk are being studied and volunteers~     are also providing urine and blood samples. 152 postmenopausal women, from the locality, will~     be recruited for this study.~   "
220125|NCT00677586|"~     The purpose of this study is to investigate the safety of simultaneous liver resections~     compared to staged hepatectomies of colorectal cancer with liver metastasis and to compare~     the long-term survival between the two groups.~   "
220126|NCT00677573|"~     We proposed to compare outcomes in women with DOR undergoing ART with rec-FSH + u-HMH with~     those with u-FSH only in GnRH antagonist protocols.~   "
220127|NCT00677560|"~     Spirometry is a useful clinical tool for the assessment and monitoring of lung disease,~     however, it does not provide information on peripheral airways resistance. On the contrary,~     impulse oscillometry (IOS) may provide information not only on airway resistance (Rrs) but~     also on the elastic properties of the lung (Xrs).~      Even though patients with asthma may show some reduction of the caliber of the small airways~     these changes are more a feature of patients with COPD. We hypothesize that IOS measurements~     may detect these differences and provide different resistance profiles for asthma and COPD.~   "
220128|NCT00677547|"~     Influenza virus is an important cause of morbidity in the transplant population and can lead~     to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for~     organ transplant patients, studies have shown that the standard inactivated influenza vaccine~     has poor immunogenicity in this population. One major hurdle in the evaluation of the~     response of influenza vaccine in immunocompromised patients is the lack of correlation~     between humoral response and efficacy of the vaccine. In patients with poor immune responses,~     cellular immunity may have a better correlation than humoral immunity with vaccine~     protection. We plan to assess the utility of 3 assays that evaluate the cell-mediated immune~     response (granzyme B, interleukin-10 (IL-10), and interferon-gamma (IFN-)) after influenza~     vaccine in kidney transplant recipients. Results from this study have the potential to~     directly improve patient care. The new monitoring assays may more accurately determine the~     risk for development of influenza infection, and therefore allowing a better prevention~     strategy.~   "
220129|NCT00677534|"~     The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a~     potential contributor to the morbidity witnessed in patients with end-stage renal disease~   "
220130|NCT00677521|"~     The objective of this study is to demonstrate a reduction of intrahepatic fat as measured~     with Proton Magnetic Resonance Spectroscopy after 12 weeks administration of oral acarbose.~     The study will also examine the hypothesis of whether the chronic administration of acarbose~     in patients with NAFLD will influence postprandial substrate metabolism reflected in the RQ~     measured by indirect calorimetry.~   "
220131|NCT00677508|"~     We propose to develop parent and child disease-specific instruments to assess health related~     quality of life (HRQoL) in children with constipation and fecal incontinence.~   "
220132|NCT00677495|"~     Undetected or untreated CD may cause severe complications later in life, such as autoimmune~     disorders.~      It is recommended for subjects with autoimmune diseases or at risk for CD to be screened for~     CD and to repeat serological screening about every three years to detect cases of clinically~     silent, late-onset CD.~      Celiac disease (CD) auto-antibodies against tissue transglutaminase (anti-tTG) are produced~     in the intestinal mucosa even when not measurable in serum. By using the phage display~     libraries technique it is possible to investigate in vivo (intestinal biopsy) early antibody~     responses in autoimmune disease. In particularly, this technique demonstrated that the~     humoral response against tissue transglutaminase occurs at the intestinal mucosal level, and~     that the human VH5 gene is the commonly used variable region by the celiac patients to build~     the anti-tTG. The intestinal mucosa production of IgA anti-tTG could be important in the~     diagnostic work-up of early-stage CD, when mucosal histology is not yet diagnostic.~      The investigators propose to 1) first degree relatives of CD patients, 2) subjects with~     autoimmune disease, 3) symptomatic subjects (genetically predisposed to gluten intolerance)~     tested negative for CD related autoantibodies and with apparently normal intestinal mucosa a~     prospective study to uncover early-stage of gluten intolerance by measuring the mucosal VH5~     restricted gene family anti-tTG clones in two biopsies: before and after one year of gluten~     free-diet (GFD).~      Aims of this clinical trial are:~        1. to measure by means of phage display libraries the gluten dependent humoral immune~          response (anti-tTG) of the intestinal mucosa in subjects with high risk of untreated CD,~          without CD-related intestinal lesions.~        2. to demonstrate the mucosal gluten-dependent immune response before and after 12 months~          of gluten-free diet~        3. to demonstrate that dietary intervention might modify the clinical condition (e.g~          improvements of the gastrointestinal complaints or extra-gastrointestinal symptoms) of~          the enrolled patients and the improvement of the intestinal inflammation with the~          disappearance of the mucosal anti-tTG.~        4. to evaluate the specificity of the double staining technique for detecting IgA~          antitransglutaminase mucosal deposit with the phage display antibodies assay~   "
220133|NCT00677482|"~     Cytomegalovirus (CMV) is the most common viral infection in patients who have undergone a~     transplant.Serious infections due to CMV can affect many parts of the body including the~     lungs, the gut, and the liver. The purpose of this study is to assess how the virus interacts~     with the patient's immune system, so that in the future it may be possible to develop better~     ways to prevent and treat the virus infection.~   "
220134|NCT00677469|"~     The enterohepatic circulation of thyroid hormones is increased in thyrotoxicosis.Bile-salt~     sequestrants (ionic exchange resins) bind thyroid hormones in the intestine and thereby~     increase their fecal excretion. Based on these observations, the use of cholestyramine has~     been tried. The present study evaluates the effect of low doses of cholestyramine as an~     adjunctive therapy in the management of hyperthyroidism~   "
220135|NCT00677456|"~     There are four capital reconstructions after total gastrectomy which is widely used in China.~     Life quality is the only standard to evaluate postoperative results of different~     reconstructions. In order to determine the best reconstruction after total gastrectomy, we~     designed this study to compare life qualities of four reconstructions.~   "
220136|NCT00677443|"~     Primary objective :~      To compare the combination of S-1 and oxaliplatin(SOX) to the combination of capecitabine and~     oxaliplatin(COX) therapy for advanced or metastatic colorectal carcinoma.~      Secondary objectives :~        1. To evaluate and compare the efficacy (overall survival and response rate) in the two~          treatment groups.~        2. To evaluate and compare the quality of life of the patients and safety profiles of the~          two treatment groups.~   "
220137|NCT00677430|"~     The first objective of this study is to assess the accuracy of digital image-processing~     techniques to provide measurements of human breast physical dimensions. The ultimate~     usefulness of these techniques is to develop quantitative outcome measures of the visual~     appearance of breast after local treatments for breast cancer. These measures will be used to~     improve clinical outcomes from multimodality therapy that includes surgery and radiotherapy~     and form the basis for the future development of patient decision making aids. The second~     objective is to evaluate the relationship between patient reported body image outcomes and~     measurement of human breast physical dimensions for patients with breast cancer.~   "
220138|NCT00677417|"~     The values of laboratory examinations which are useful for the diagnoses of appendicitis are~     white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation~     rate (ESR). However up to date there is no laboratory marker for the pre-operative diagnosis~     of appendiceal perforation in acute appendicitis. Recently hyperbilirubinaemia has been~     associated with appendiceal perforation. Aim of this retrospective study is therefore to~     investigate if hyperbilirubinaemia has a diagnostic value for the pre-operative diagnosis of~     appendiceal perforation in patients with appendicitis.~   "
220139|NCT00677404|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of mononuclear cells with and without G-CSF in patients with chronic lower~     limb ischemia.~   "
220142|NCT00677365|"~     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory~     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which~     has been particularly problematic to eradicate and been implicated as the major cause of~     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung~     increases the local concentrations of antibiotic at the site of infection resulting in~     improved antimicrobial effects compared to systemic administration. Bacterial resistance to~     current aerosol antibiotic treatments indicate a need for improved therapies to treat CF~     patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and~     other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to~     have antimicrobial effects on even the most resistant organisms.~   "
220143|NCT00677352|"~     To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with~     panic disorder.~   "
220144|NCT00677339|"~     The purpose of this study is to determine whether adjunctive L-arginine and vitamin D can~     improve response to standard short course TB therapy in people with newly diagnosed pulmonary~     TB.~   "
220145|NCT00677326|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201~     restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in advanced~     breast cancer patients.~   "
220146|NCT00677313|"~     This is an open-label study to provide metreleptin for the treatment of diabetes mellitus~     and/or hypertriglyceridemia associated with lipodystrophy. This study intends to provide~     guidance to investigators with respect to identification of appropriate subjects for~     metreleptin treatment, guidance on metreleptin dosing, and collection of safety and efficacy~     data following metreleptin treatment in this population~   "
220147|NCT00677300|"~     The purpose of this study is to determine whether a combination of raltegravir and darunavir~     is as effective as standard regimens in the treatment of HIV-infected patients who have not~     previously used antiretroviral drug (treatment naive)~   "
220148|NCT00677287|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402~     restricted epitope peptides RNF43, TOMM34, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51~     in combination with Tegafur/Uracil/Folinate chemotherapy.~   "
220149|NCT00677274|"~     Epidural analgesia in the early stage of labor at cervix < 4.0cm was considered as a risk~     period for increasing the rate of cesarean delivery. The more recent studies and the~     investigators' previous data indicated epidural analgesia can be performed as early as the~     cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix~     diameter had different rate of cesarean delivery. This trial would investigate the~     correlation amongst different cervical dilation and the risk of cesarean section in~     nulliparous women at term.~   "
220150|NCT00677261|"~     Many methods of pain relief have been implemented in an attempt to provide safe and effective~     analgesia for patients following total knee arthroplasty. Numerous studies have demonstrated~     that nerve blocks can provide superior pain control and reduce side effects. There are two~     major nerves that provide sensation to the knee: the femoral nerve provides sensation to the~     front of the knee and sciatic nerve provides sensation to the back of the knee. Putting local~     anesthetic close to these nerves provides superior pain control. The literature has supported~     the use of femoral nerve block for analgesia as well as improved functional outcome after~     total knee arthroplasty. The purpose of this study is to see if the same is true for sciatic~     nerve block for the back of the knee. We also would like to study an alternative approach to~     make the back of the knee pain free. This involves injecting local anesthetic directly into~     this area at the end of your surgery.Patients will be randomized into 3 groups: sciatic~     block, posterior infiltration of local anesthetic and placebo.This study will help further~     define the role of sciatic nerve block as well as the alternative technique of local~     anesthetic infiltration in the perioperative analgesic regimen of total knee arthroplasty~     surgery, in an effort to develop a standardized perioperative protocol for this patient~     population. The advent of this protocol should allow reduced risk, improved analgesia, and~     potentially earlier discharged from hospital with better function.~   "
220151|NCT00677248|"~     Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in~     the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has~     in clinical trials demonstrated pronounced reduction of several independent risk factors for~     the development of atherosclerotic cardiovascular diseases.~      The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to~     ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to~     assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a~     clinically relevant dose or dose range for future studies.~   "
220152|NCT00677235|"~     The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR~     Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or~     other synthetic arteriovenous (AV) access grafts.~   "
220153|NCT00677222|"~     The purpose of this study is to determine if escalating doses of AMI MultiStem® delivered by~     catheter can safely be given to patients that have had a recent heart attack treated with~     stent implantation.~   "
220154|NCT00677209|"~     House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the~     eyes, and running nose. The investigators test a possibility to immunize subjects sensitized~     against house dust mite with extracts from their own gut bacteria auto-vaccination.~   "
220155|NCT00677196|"~     The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of~     pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).~   "
220156|NCT00677183|"~     The purpose of this study is to document how often specific genotypes known to be associated~     with adult-onset NASH (Non-Alcoholic Steatohepatitis) occur in a pediatric cohort and~     investigate whether these genotypes are associated with increased susceptibility to NASH.~   "
220157|NCT00677170|"~     This study is an open-label, multicenter, Phase 1, dose escalation study of MLN4924 in adult~     patients with nonhematologic malignancies. This study will be the first to administer MLN4924~     in humans. The patient population will consist of adults with any form of nonhematologic~     malignancy for which standard, curative, life prolonging, or palliative treatment does not~     exist or is no longer effective.~   "
220158|NCT00677157|"~     This study will examine people who have pain or fatigue symptoms with a known or unknown~     diagnosis to determine eligibility for other research studies. No treatment is offered under~     this protocol.~      People 18 years of age or older with symptoms of pain and fatigue may be eligible for this~     study. Participants undergo standard examinations needed to diagnose or evaluate their~     symptoms. The results of the test are used to screen subjects for possible participation in~     other Nursing Institute studies. The study requires from one to three visits at NIH over 12~     months for procedures that may include the following:~        -  Medical history, physical examination and questionnaires related to symptoms and quality~          of life.~        -  Blood tests~        -  Electrocardiogram~        -  Tender point testing. Pressure is applied to areas of the shoulder, hip, neck, chest,~          elbow and knee to identify tenderness.~   "
220159|NCT00677144|"~     The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and~     Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent colorectal cancer.~   "
220160|NCT00677131|"~     The primary purpose of this study is to evaluate the patient education efficacy of the~     pharmacists in National Taiwan University Hospital. We randomize patient family into one of~     the following three groups:~        1. To read the package insert of the drug~        2. To read the education information provided by Pharmacy of NTUH~        3. Oral education provided by the pharmacist~      Then we will evaluate the difference on patient knowledge of reconstitution, storage, and~     administration of oral antibiotic suspension from powder dosage form between these three~     groups.~   "
220161|NCT00677118|"~     The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant~     chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC,~     in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC)~     patients.~   "
220162|NCT00677105|"~     The purpose of this study is to assess the safety of the drug (JNJ-24681585 a drug in~     development for cancer) in patients with advanced or refractory solid malignancies or~     lymphoma on the maximum dose that can be tolerated by these patients. The absorption,~     breakdown and elimination of the drug will be studied and in some patients, the effect of the~     food on these processes will also be examined.~   "
220163|NCT00677092|"~     The purpose of this study is to determine the efficacy of imatinib mesylate in reducing~     cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (NSF). The~     study will also work to assess the safety and tolerability of imatinib mesylate in patients~     with chronic kidney disease and NSF.~   "
220164|NCT00677079|"~     The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in~     patients with breast cancer gene-associated (BRCA) ovarian cancer.~      Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were~     to be treated in a first stage, then if 2/12 patients responded to treatment as defined by~     Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated~     in the second stage.~   "
220165|NCT00677066|"~     Home oxygen therapy is considered an appropriate and relatively safe option for children with~     chronic respiratory problems such as chronic lung disease of prematurity, but the use of home~     oxygen therapy for children with acute respiratory problems is limited. With the recent~     establishment of a Hospital in The Home (HiTH) program at our institution, we sought to~     determine the safety, parental satisfaction and economic advantage of home oxygen therapy for~     children with acute bronchiolitis compared with traditional inpatient hospitalization.~   "
220166|NCT00677053|"~     The purpose of this study is to determine the safety and tolerability of multiple doses of~     TAK-442once daily, (QD) or twice daily (BID), in subjects with acute coronary syndrome~     (unstable angina, myocardial infarction).~   "
220167|NCT00677040|"~     This study involves women who have had a diagnosis of breast cancer, and have had a~     lumpectomy with radiation treatments completed in the past year.~      The study will determine the level of oxygen in the skin of the breast that has been~     radiated, compared with the normal skin of the opposite breast.~      The purpose of this study is to determine if there is a decrease in oxygen levels in the skin~     which has been radiated, hopefully to find a treatment to limit skin damage caused by~     radiation treatments, for women with breast cancer in the future.~   "
220168|NCT00677027|"~     The purpose of this study is to evaluate the safety of increasing doses of MM-10-001 and to~     determine the dose of MM-10-001 that enhances the immune system in normal healthy subjects.~   "
220169|NCT00677014|"~     The primary objective of SMART-AV is to assess the effect of SmartDelay for determining~     optimal AV delay timing during CRT compared to both a fixed AV delay and~     echocardiography-determined optimal AV timing chronically over a 6-month period.~   "
220170|NCT00677001|"~     The purpose of this study is to assess the safety of R306465 (a drug in development for~     cancer) in patients with advanced cancer on the maximum dose that can be tolerated. Also, the~     absorption, breakdown and elimination of the drug will be studied.~   "
220171|NCT00676988|"~     To assess the relationship between the change in Crohn's Disease Activity Index (CDAI) scores~     and trough serum infliximab concentration in subjects who are scheduled to receive infliximab~     infusions at an interval of 8 weeks.~   "
220172|NCT00676975|"~     To test the efficacy of Traditional Chinese Medicine in relieving symptoms and change of~     quality of life of patients with Irritable Bowel Syndrome.~   "
220173|NCT00676962|"~     The investigators propose to test the effect of external facilitation on the extent that~     brief cognitive behavioral therapy (CBT) for depression is incorporated into routine practice~     in primary care and community based clinics in the VA. The investigators will provide~     training in brief CBT to mental health providers in participating clinics. To the~     investigators' knowledge, this will be the first study of the effect of external facilitation~     on outcomes of a training intervention.~   "
220174|NCT00676949|"~     The purpose of this study is to evaluate the clinical safety and efficacies of~     cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed~     solid tumors including GI/lung/cervical cancers~   "
220175|NCT00676936|"~     Study hypothesis: corticosteroids are effective for pain in cancer patients. We will perform~     a double-blind, randomized, placebo-controlled multicentre trial evaluating the effect of~     Methylprednisolone 16 mg twice daily in cancer patients with pain (average pain last 24 hrs~     NRS > 4 (Numerical rating scale, 0 No pain, 10 worst pain).~   "
220180|NCT00676871|"~     Phase 1:~        -  Evaluate the safety and tolerability of MEDI-538 given by escalated doses with~          continuous IV infusion for 4 weeks in adult patients with CLL.~        -  Determine the maximum tolerated dose (MTD) of MEDI-538 administered by continuous IV~          infusion for 4 weeks in this patient population~        -  Describe the pharmacokinetics (PK) of MEDI-538~        -  Describe the immunogenicity (IM) of MEDI-538~        -  Determine the overall response, which is defined as follows: (1) conversion from PD/SD~          to PR/nPR/CR or conversion from PR to nPR/CR using standard NCI-WG criteria; or (2)~          conversion from MRD positivity to MRD negativity using 4-color flow cytometry; and~        -  Describe any antitumor activity (ie, time to response and duration of response) of~          MEDI-538 in this patient population.~      Phase 2:~        -  To determine the overall response in adult patients with CLL who have residual disease~          following previous therapy for CLL.~        -  Describe the safety,PK,and IM of MEDI-538~        -  Determine the time to MRD relapse~        -  Determine the antitumor activity (ie, time to response, duration of response,and time to~          progression [TTP])of MEDI-538 in this patient population.~   "
220181|NCT00676858|"~     The purpose of this study is to use transesophageal echocardiography (TEE) to determine the~     incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation~     (APC).~   "
220182|NCT00676845|"~     This study will analyse the dose-dependent effect of olmesartan medoxomil on the change in~     arterial stiffness in subjects with hypertension and metabolic syndrome~   "
220183|NCT00676832|"~     The purpose of this study is to determine whether COLAL-PRED is a safe and effective~     treatment for patients with moderate to severe ulcerative colitis.~   "
220184|NCT00676819|"~     This trial is conducted in Europe. The aim of this trial is to investigate if the~     pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are~     different in elderly (65 years of age or older) with type 2 diabetes.~   "
220185|NCT00676806|"~     This study is designed to determine whether Umbilical Cord Transplantation (UCB) can be~     substituted for adult bone marrow cells in the standard stem cell transplant regimens used at~     this hospital for subjects who do not have stem cell donors.~   "
220186|NCT00676793|"~     To see if an extract of green tea can affect certain markers of breast cancer and breast~     cancer progression in women with a recent biopsy positive for cancer and who are scheduled~     for surgery.~   "
220187|NCT00676780|"~     The purpose of the study is to see if a green tea extract can beneficially alter several~     markers of cancer risk and progression.~   "
220188|NCT00676767|"~     The purpose of this study was to determine how blood glucose changes after eating energy bars~     containing resistant starch type 4 compared with bars made with puffed wheat in healthy older~     adults.~   "
220189|NCT00676754|"~     The purpose of this study is to better understand tuberculosis (TB) and the risk of infection~     with TB, in Peru. TB is a disease that is caused by bacteria and transmitted through droplets~     in the air that come from the lungs of an infected person. The risk of infection will be~     compared between two groups: household members, who live with people having TB that does not~     respond well to treatment and household members, who live with people having TB that responds~     well to treatment. Study participants will include 4,500 TB infected people and 22,500 of~     their household contacts. Study procedures include answering a questionnaire, TB skin tests,~     blood samples, and a chest x-ray. Individuals with symptoms indicating TB will be asked to~     provide sputum samples. Individuals with TB will be involved in the study for up to 48~     months; household contacts will be involved in the study for 12 months. The knowledge gained~     from this study will be used to improve tuberculosis control.~   "
220190|NCT00676741|"~     The study is conducted in Europe. The aim of this observational study is to evaluate the~     blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir®~     for the treatment type 2 diabetes.~      Full acronym for this study: COMMIT - CLEAN SWITCH~   "
220191|NCT00676728|"~     The purpose of this study is to explore the safety, pharmacokinetic (what the body does to~     the medication), pharmacodynamic (what the medication does to the body), and activity of~     JNJ-26481585 in patients with advanced or refractory leukemia and myelodysplastic syndrome~     (MDS).~   "
220192|NCT00676715|"~     This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and~     Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as~     measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants~     with Relapsing Remitting Multiple Sclerosis (RRMS).~   "
220193|NCT00676702|"~     The purpose of the study is to evaluate the enzyme activity and safety of pancrelipase in~     patients with severe Exocrine Pancreatic Insufficiency (EPI)~   "
220194|NCT00676689|"~     To assess the safety and effectiveness of pulmonic THV implantation in subjects with~     dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation~     (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by~     TTE.~   "
220195|NCT00676676|"~     The purpose of the study is to determine whether adding a low dose of testosterone to current~     antidepressant therapy improves depression and fatigue in women who remain depressed despite~     necessary adequate doses of anti-depressants. Testosterone will be given over an 8-week~     period.~      Testosterone is a hormone that occurs naturally in the body. In women it comes from the~     ovaries and adrenal glands and is found in amounts that are ten to twenty times lower than in~     men.~      In early research studies, testosterone has been shown to have some antidepressant effects in~     the following groups of subjects:~        -  Women with anorexia nervosa~        -  Women who have low testosterone levels because their pituitary glands do not work~        -  Men with Selective Serotonin Reuptake Inhibitor (SSRI)-resistant depression.~      However, testosterone administration in women with SSRI or Serotonin-norepinephrine reuptake~     inhibitor (SNRI) -resistant depression has not been studied.~   "
220196|NCT00676663|"~     The purpose of this study is to evaluate the safety and efficacy of entinostat in combination~     with exemestane in the treatment of advanced breast cancer.~   "
220197|NCT00676650|"~     This study will compare the safety and efficacy of sunitinib in combination with prednisone~     versus placebo and prednisone in patients that have metastatic castration-resistant prostate~     cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen.~     This is a second-line study.~   "
220198|NCT00676637|"~     The purpose of this study is evaluate adherence to DuoTrav® when reinforced by the use of the~     Travalert™ Dosing Aid.~   "
220199|NCT00676624|"~     Uveitis is an inflammatory disease of one or both eyes. Uveitis will in severe cases lead to~     permanent loss of vision/blindness on the affected eye. Uveitis can be caused by autoimmune~     disease, infections and rarely trauma, but 50 % of the cases remain of unknown origin.~     Intraocular infections are from previous studies, known to be responsible for approximately~     40 % of the cases of severe forms of uveitis. Most infectious causes of uveitis have the~     potential to be treated with antibiotic.~      Most infectious causes of uveitis are under normal condition only possible to detect by using~     very specific detection methods. Further more it is often necessary to study a sample from~     with-in the eye (vitrectomy to get a proper diagnosis. The knowledge about witch kind of~     infections that causes uveitis, are therefore limited to the kind of infections that are~     tested for.~      Our hypothesis are that infections are a frequent cause of severe uveitis in Denmark, and~     that by using a broad diagnostic approach it is possible to identify new or less recognized~     infections agents that are associated with uveitis. By this study we want to describe the~     prevalence and distribution of infections among patients with severe uveitis. In this study~     are we only including patients with a severe form of uveitis from a referral-hospital~     setting, where vitrectomy is done for a diagnostic purpose.~      The patients will undergo a standard diagnostic examination including the most common~     infectious causes of uveitis. Beside this we will look for a broad range of infection, which~     has previously been described in the litera-ture to cause uveitis, but are not normally~     tested for. Further more, we will use broad ranged molecular diagnostic methods to look for~     new previously unknown bacterial causes of uveitis. Such study has not previously been done~     previously in Denmark. As control group are included patients that undergo vitrectomy for due~     either one of the two diseases epiretinal fibrosis or macula hole. All patients and~     controls will be interview using a standardized questionnaire about risk factors for~     acquiring these infections.~   "
220200|NCT00676611|"~     The purpose of this research is to study a specific acetabular (hip socket) fracture pattern~     and how its treatment affects the functional, clinical, and x-ray outcomes. There are no~     experimental procedures involved.~   "
220201|NCT00676598|"~     Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients~     resuscitated after ventricular fibrillation arrest.~      Few studies have examined whether therapeutic hypothermia is effective outside the research~     setting, or with other presenting rhythms.~      Our institution, a large community teaching hospital, instituted a therapeutic hypothermia~     protocol in November 2006 for all resuscitated cardiac arrest patients.~      The investigators seek to determine the mortality rate of our protocol and compare our~     complication rates with those of previously published studies.~   "
220202|NCT00676585|"~     The major goal of this project is to determine whether the use of physiologic doses of~     corticosteroids will decrease time to shock reversal, alters the inflammatory cascade, and~     alters microcirculatory flow in post-cardiac arrest patients.~   "
220203|NCT00676572|"~     This research aims to find out how the inflammation in patients suffering from severe asthma~     is different from that in non−severe asthma, and how it may prevent corticosteroids from~     working efficiently in severe asthma.~      It will look,in particular, at a protein enzyme called p38 mitogen−activated protein kinase~     (p38 MAPK for short)which controls the activation of several important pathways in the cell.~     We wish to find out whether this enzyme is more active in cells obtained from patients with~     severe asthma compared to those with non−severe asthma. We would like to understand how this~     enzyme can cause the cell to respond less well to the anti−inflammatory effects of~     corticosteroids. We also wish to find out whether any specific inhibitors of p38 MAPK can~     improve severe asthma by improving the effects of corticosteroids on these cells.~      We hypothesise that activation of the intracellular MAPK signalling pathway underlies the~     inflammatory processes of severe asthma, and leads to the diminution of the anti-inflammatory~     actions of CS through histone modification.~   "
220204|NCT00676559|"~     This study looks to continue the study of anti-vegf therapy in patients with macular edema,~     and compare it to an anti-inflammatory therapy and a combined Anti-vegf and~     anti-inflammatory.~   "
220205|NCT00676533|"~     The primary objective of this clinical trial was to determine the time to improvement of the~     signs and symptoms (eg, dysuria, frequency, urgency, gross hematuria, suprapubic pain,~     hesitancy, low back pain) of acute, uncomplicated, symptomatic, lower UTIs in women treated~     with Cipro XR 500 mg once daily for 3 days.~   "
220206|NCT00676520|"~     XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives~     of this study are~        -  To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in~          real world settings, and~        -  To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT)~          initiative. This initiative is designed to evaluate the composite of all death,~          myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free~          from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and~          that have been treated with drug eluting stents (DES) and extended dual antiplatelet~          therapy.~   "
220207|NCT00676507|"~     Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune~     response to kill tumor cells. It is not yet known whether vaccine therapy is more effective~     than a placebo as maintenance therapy in treatment of subjects with non-small cell lung~     cancer.~      Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works~     compared with a placebo in treating subjects with stage III or stage IV non-small cell lung~     cancer.~   "
220208|NCT00676494|"~     The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active~     removal of atherosclerotic debris and thrombus in peripheral vasculature.~      This is a prospective, single arm, multi-center study to obtain safety and performance data~     for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for~     percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the~     lower limb peripheral vasculature.~   "
220209|NCT00676481|"~     The purpose of this study is to test data collection options in emergency departments (EDs)~     and to enhance ED patient awareness of the risk of HIV infection.~   "
220210|NCT00676468|"~     Combining fish oil supplementation and Montelukast [a commonly used cyst LT1 receptor~     antagonist to treat exercise-induced bronchoconstriction (EIB)] will provide a greater~     antiinflammatory effect against developing EIB that either agent alone~   "
220211|NCT00676455|"~     The purpose of this study is to evaluate the ability of a new type of CT computer~     program(MeVis™)to accurately analyze and measure the size and changes in metastatic Liver and~     Lung tumors. This study will evaluate the data from current CT evaluation methods using the~     MeVis™ 3-D software.~   "
220212|NCT00676442|"~     We will evaluate the effect of food on the bioavailability of the components of PN400~   "
220256|NCT00675857|"~     The main objectives of the current study are to establish the safety and clinical~     proof-of-concept of NC-503 in inadequately controlled patients with Type 2 diabetes and~     features of metabolic syndrome treated with either metformin, a sulfonylurea agent, or~     metformin in combination with a sulfonylurea agent.~   "
220213|NCT00676429|"~     To investigate and compare the efficacy, safety and tolerability of ziprasidone versus~     placebo in the treatment of conduct disorder (CD), oppositional defiant disorder (ODD) and~     disruptive behavior disorder not otherwise specified (DBD-NOS) of older children and~     adolescents in an outpatient setting.~      Conduct and other behavior disorders are some of the most common forms of psychopathology in~     children and adolescents. The main characteristic of these disorders is a repetitive and~     persistent pattern of antisocial, aggressive or defiant behavior that involves major~     violations of age-appropriate expectations or norms. According to the guidelines of the~     German Society for Child & Adolescent Psychiatry & Psychotherapy (Deutsche Gesellschaft für~     Kinder- und Jugendpsychiatrie und -psychotherapie DGKJPP), the European Society for Child and~     Adolescent Psychiatry (ESCAP), and the American Academy of Child and Adolescent Psychiatry~     (AACAP) currently no standard pharmacotherapy is established and recommended for children and~     adolescents. However Risperidone has been shown to be effective in the treatment of patients~     with disruptive behavior disorders and below average IQ.~   "
220214|NCT00676416|"~     The change of airway responsiveness and alveolar macrophage (AM) immunity occurs during the~     pathogenesis of asthma. Macrophage-associated airway protection in patients with asthma is~     affected positively or negatively by propofol general anesthesia. The investigators~     hypothesized that the effects of propofol on asthmatic AMs and corresponding airway~     reactivity in vivo is different from the in vitro research. Through in vivo airway~     hyperresponsiveness (AHR) observation and clinical investigation of AM immune functions from~     asthma patients undergoing propofol general anesthesia to clarify the precise effects of~     propofol on AM immunity, and to provide theoretical basis for the clinical administration of~     propofol in asthmatic patients. This would optimize the practice of clinical anesthesia,~     especially for those with the tendency of AHR.~   "
220215|NCT00676403|"~     To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients~   "
220216|NCT00676390|"~     The treatment and follow-up of congestive heart failure (CHF) represents a major part of~     France's health expenses. The beneficial effects of cardiac rehabilitation is well~     established, especially regarding the reduction of dyspnea, exercise limitation and fatigue~     and leads ultimately to a better quality of life. Maintaining these benefits in secondary~     prevention requires an improvement in daily physical activity, which is challenging and~     supposes a close follow-up difficult to perform on a daily living basis. However, a better~     knowledge of the type and dose of daily physical activity of this population would be very~     beneficial for the practitioner to prescribe or advise individually the type and the dose of~     physical activity required to maintain the benefits of cardiac rehabilitation. To date, only~     a physical activity questionnaire adapted to CHF could provide information regarding both the~     type and dose of daily physical activity. Such a questionnaire has been developed by our~     research team and allows an estimation of daily energy expenditure as well as the daily~     energy expended in its physical activity dimensions (rest, activities < 3 MET, activities~     between 3 and 5 MET, and activities > 5 MET). During its first step of validation, daily and~     physical activity energy expenditure estimated by this questionnaire was correlated to~     various factors of physical condition and notably, to peak V'O2 (R=0.71), prognostic factor~     largely recognized in CHF. A second step of validation was a pilot study comparing the~     estimation of daily energy expenditure by the questionnaire with a measurement of free-living~     daily energy expenditure with the doubly labelled water (DLW) method in 11 middle-aged males~     patients suffering CHF (NYHA I to III). Daily energy expenditure estimated from the~     questionnaire was very close to daily energy expenditure measured from the DLW method (R2 =~     0.81; individual relative error < 7%). However, the high cost of the DLW method reduced the~     population studied to a small sample, which is a major limitation of this study since the~     sample was somewhat different to general CHF population in France.~   "
220217|NCT00676377|"~     Postoperative ileus (POI) in the absence of any mechanical obstruction remains a commonly~     encountered clinical problem.So, this study aimed to show the effective way to decrease the~     rate of postoperative Ileus (POI).~   "
220218|NCT00676364|"~     The purpose of this study is to evaluate the amount of anxiety and pain felt by children~     during procedures that require a needle stick after using a topical anesthetic or placebo~     cream.~   "
220219|NCT00676351|"~     A significant proportion of asthma is diagnosed during childhood. Bronchiolitis is the most~     common lower respiratory tract illness (LRI) in early life and the present work is a~     prospective study undertaken to highlight the possible relationship between LRI in early life~     and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function~     testing.~      Twenty nine infants (8 females and 21 males) were included in our study. The beginning of the~     study started at least three weeks after the first bronchiolitis episode. Pulmonary function~     test was realized using an infant specific body plethysmography (Babybody, Erich Jaeger,~     Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary~     function was evaluated by measuring respiratory resistances using oscillometry and occlusion~     systems (Masterlab-IOS, Erich Jaeger, Germany). If measured data showed an obstruction, a~     bronchodilatator was inhaled to assess reversibility. When results were normal, a bronchial~     provocation test, using inhaled metacholine, was performed.~      Skin prick tests (SPTs) were performed during the first exam, and at 24 and 36 months~     (Stallergenes-DHS).~      Collection of data was largely incomplete due to a number of patients lost of follow up.~     Based on the available data, it can be conclude that most of lung tests results were in the~     normal range but a non negligible bronchial hyper reactivity was documented (41% of~     patients).~      This study must be continued to increase the number of included patients and to continue~     their follow up during a longer time.~   "
220220|NCT00676338|"~     This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy~     to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione)~     in drug naive patients with type 2 diabetes treated with diet and exercise.~   "
220221|NCT00676325|"~     A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the~     anterior vaginal wall prolapse.~   "
220222|NCT00676312|"~     This study is designed to investigate the safety and tolerability of PTH134 in healthy~     subjects and to assess the exposure from PTH134.~   "
220223|NCT00676299|"~     The purpose of this study is to assess JNJ-26483327 (a drug in development for cancer) for~     the safety of the drug in patients with advanced solid tumors that have not responded or are~     no longer responding to available therapies. The absorption, breakdown and elimination of the~     drug will also be studied.~   "
220224|NCT00676286|"~     This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers~     and determine if these tests can detect cancers that become aggressive.~   "
220225|NCT00676273|"~     The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and~     TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and~     clinical efficacy in the treatment of stress urinary incontinence alone or the stress~     component in mixed urinary incontinence.~   "
220226|NCT00676260|"~     The purpose of this study is to measure microcirculation in type 2 diabetes patients with~     peripheral edema who are taking pioglitazone, once daily (QD).~   "
220227|NCT00676247|"~     Although several studies have contrasted the hemodynamics of cerebral arteries using cranial~     Doppler ultrasound between full-term and preterm infants, the assessments were mostly~     conducted in the first days of life. Furthermore, the clinically significant hemodynamic~     parameter has been established from a small sample of infants that its validity on other~     populations remains unclear. Therefore, the purpose of this study is twofold:~        1. to examine the hemodynamics of cerebral arteries in full-term and very low birth weight~          preterm infants at term age~        2. to assess the validity of the hemodynamic parameters in relation to concurrent~          neurobehavioral function.~      This study will enroll normal full-term infants and very low birth weight preterm infants who~     have no major neonatal disease. Cranial Doppler ultrasound examination will be performed on~     all infants at term age. Hemodynamic parameters will include peak systolic velocity, end~     diastolic velocity, resistance index and pulsatility index for the bilateral anterior~     cerebral arteries and middle cerebral arteries. Neurobehavioral development will be~     administered on the same day using the Neonatal Neurobehavioral Examination- Chinese version.~   "
220228|NCT00676234|"~     Pilot study aiming to assess the effect of two doses of rhu EPO on urine NGAL concentration~     and on serum cystatin C and creatinine levels in critically ill patients at risk of ARF.~   "
220229|NCT00676221|"~     Hypothesis: Presently, some patients' mycophenolate mofetil (MMF.,Cellcept) related~     gastrointestinal (GI) symptoms are not being spontaneously reported. It is postulated that a~     conversion to enteric-coated mycophenolate sodium (EC-MPS.,Myfortic) from MMF will reduce the~     objectively measured GI symptom burden and improve GI-related quality of life.~      Primary Objective: To determine the incidence of GI-related symptoms and the health related~     quality of life of renal transplant patients that are currently tolerating MMF. Assessed by~     GSRS and GIQLI.~      Secondary Objective: To determine the impact on GI symptoms and the health related quality of~     life of renal transplant patients converted from MMF to Myfortic. Assessed by GSRS and GIQLI.~   "
220230|NCT00676208|"~     While medical training has increasingly included chronic care management, quality care~     necessitates education approaches that go farther. In April 2005, the Louis Stokes Cleveland~     Veterans Affairs Medical Center (VAMC) implemented a weekly Diabetes Shared Medical~     Appointment (SMA). SMAs offer an important opportunity to improve chronic care and a unique~     setting for training physicians. In order to equip physicians with needed resources to manage~     chronic care, the ways in which SMA experiences are processed and integrated into learning~     about interdisciplinary approaches and expanding trainees' understanding of chronic care~     issues need to be examined.~   "
220231|NCT00676195|"~     The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC)~     in children with Autism.~   "
220232|NCT00676182|"~     The scientific objective of this program is to meet the rehabilitation needs of combat~     wounded Veterans with mild to moderate Traumatic Brain Injury (TBI) via telerehabilitation~     and determine the effect of this modality of care on patients' physical health and outcomes~     including function and community participation. The investigators will also evaluate the~     benefits and limitations of rehabilitation using telehealth from the Veteran and caregiver~     perspectives and evaluate the impact of rehabilitation via telehealth on Veterans~     Administration (VA) healthcare facility use.~   "
220233|NCT00676169|"~     The purpose of this study is to better define risk factors preceding first isolation of~     Pseudomonas aeruginosa (Pa) from respiratory cultures in cystic fibrosis (CF) lung disease~     and to better define clinical outcomes associated with acquisition of Pa. This study will~     also collect and bank DNA samples for current and future studies designed to enhance the~     understanding of the pathogenesis of CF.~   "
220234|NCT00676156|"~     The purpose of this study is to learn about an investigational drug known as oral lipoic acid~     (LA) that may help treat multiple sclerosis. This study will measure how a person's body~     absorbs and breaks down the drug (pharmacokinetics) and will compare four different forms of~     the drug from four different manufacturers as well as LA in conjunction with fish oil.~   "
220235|NCT00676143|"~     This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in~     patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab~     or placebo. Each patient's participation will last approximately 1.5 years.~   "
220236|NCT00676130|"~     The primary aim of this study is to quantify the effectiveness of Bactrim as additional~     therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard~     therapy plus Bactrim, versus standard therapy plus placebo.~      The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence,~     subjects treated with standard therapy plus Bactrim will have higher cure rates than those~     treated with standard therapy plus placebo.~   "
220237|NCT00676117|"~     The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H)~     during repeated oral administration with and without co-administration of loxoprofen and the~     pharmacokinetic profile of loxoprofen during repeated oral administration with and without~     co-administration of Esomeprazole (D961H).~   "
220238|NCT00676104|"~     The primary goal of this project is to demonstrate the feasibility and clinical benefits of a~     new rapid treatment for secondary treatment for secondary brain injury called Discrete~     Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced~     hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral~     Hypothermia System holds a great potential for protecting the brain from the devastating~     secondary complications of trauma without the associated deleterious system effects.~   "
220239|NCT00676091|"~     The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy~     infants in Brazil for safety and tolerability, and to determine the immune response to the~     vaccines.~   "
220240|NCT00676065|"~     The objective of this study is to characterize and compare the risks of long-term use of oral~     contraceptives containing drospirenone and of other established oral contraceptives.~   "
220241|NCT00676052|"~     The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with~     placebo in subjects with COPD.~   "
220257|NCT00675844|"~     Extension study for subjects currently participating in protocols ACH443-015 and ACH443-018.~   "
220410|NCT00673842|"~     This study will assess whether an implantable defibrillator will increase the likelihood of~     survival in patients who have had a heart attack in the prior 5 years, have abnormal test~     results from a 24 hour heart monitor, and who have low normal heart function.~   "
220242|NCT00676039|"~     Generic medications should be the equivalent of brand medications with the exception of their~     price. Before a generic medication is introduced, its bioequivalence within a window of 80 to~     125% of the original has to be demonstrated. There are reports that this criterion is not~     always followed in post-marketed periods. Such investigations were triggered by the~     observation that some patients previously stable on original medications relapsed when~     switched to a presumable equivalent generic. Several factors could account for this problem.~     Given reports of such problems occurring with the antidepressants citalopram and venlafaxine,~     some pharmacokinetic properties of specific brands of generics and the originals will be~     examined for these two medications. Twelve healthy male volunteers will participate in this~     crossover study. It is anticipated that there will be significant differences emerging~     between the two formulations given the clinical reports of patients deteriorating when~     switched from the original to the generic preparations.~   "
220243|NCT00676026|"~     The goal of this series of challenge studies is to examine the impact of menstrual cycle~     phase on cortical GABA response to administration of agents with either direct~     (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While~     the impact of these agents on cortical GABA levels in women with premenstrual dysphoric~     disorder (PMDD) is of interest, this study is designed primarily for those women without a~     psychiatric illness.~   "
220244|NCT00676013|"~     The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:~        1. will reduce scar formation of skin grafts~        2. will reduce burn wound contractures~        3. will improve functional outcome of joints requiring grafts~        4. will reduce healing times and potential complications of donor sites~      Compare scarring outcome of Dermal products~   "
220245|NCT00676000|"~     Vaginal prolapse is a common condition that is treated with surgical correction. Recently~     surgeons have been using mesh to augment the repair of vaginal prolapse. Common complications~     of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in~     the vagina. There are different ways to close the vaginal wall over the mesh used in these~     procedures. Currently, there is no accepted standard method of closing the vaginal wall. The~     purpose of this study is to find out the best way to close the surgical wound in the vagina.~     We will compare interrupted closure (separate stitches) to continuous closure (one long,~     running stitch). We hope to show in our study that one method of closure is better than the~     other.~   "
220246|NCT00675987|"~     The main purposes of this study are to find out if the study drug losartan (Cozaar) or~     placebo (sugar pill) has an effect on insulin sensitivity (how your body responds to~     insulin) and to measure the effect of the study drug losartan or placebo on how the arteries~     in your arm dilate (enlarge to carry more blood).~      We hope to learn if taking losartan changes the amount of certain proteins in the blood that~     effect blood vessel function.~      Losartan is approved by the US FDA to treat high blood pressure. It will take approximately 4~     months for you to complete this study.~   "
220247|NCT00675974|"~     1. Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure~          Garment Therapy.~        2. How will Pressure Garment Therapy affect functional capacity or scar contracture~          development across joints either in number or severity.~        3. Will Pressure Garment Therapy diminish discomfort due to pruritus.~   "
220248|NCT00675961|"~     The primary goal of this study is to assess the effectiveness of two alcohol interventions~     administered singly or in combination as an integrated component of TB care provided to~     patients with co-occurring TB and AUDs in Tomsk, Russia. Here we propose two parts of this~     study:~      First, a pilot study to provide Naltrexone to TB patients will be conducted. If feasibility~     and safety are demonstrated, then we will conduct a randomized clinical trial (RCT) of the~     following four study arms:~        1. A Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard~          referral to and management by an addictions specialist);~        2. Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU~        3. BCI + Naltrexone/BBCET plus TAU~        4. TAU The RCT will be conducted only if Naltrexone use proves safe and feasible in the~          pilot study. However, because the pilot does not have a control group and nor is it a~          Phase I clinical trial, we define safety here as demonstration of appropriate adverse~          event management and adequate safety monitoring procedures, all of which will also be~          used in the RCT.~      The specific aims of the pilot are:~        1. To determine the feasibility of administering Naltrexone to patients receiving TB~          treatment, and~        2. To assess the safety of administering Naltrexone to patients receiving TB treatment.~      The investigators aim to test the following hypotheses for the pilot: co-administration of~     Naltrexone with TB treatment is feasible and safe in a population of TB patients with AUDs.~      The specific aims of the RCT are:~        1. To compare TB treatment outcomes among patients in each of the three intervention arms~          with the control arm of treatment as usual, and~        2. To compare the change in mean number of heavy drinking days in last month of study~          period compared with baseline among patients in each of the three intervention arms with~          the control arm of treatment as usual.~      The investigators aim to test the following hypotheses for the RCT: Individuals receiving one~     of the three interventions (Naltrexone, BCI or the combination of Naltrexone/BCI) will~     experience better TB outcomes and a greater change in the mean number of heavy drinking days,~     compared with individuals receiving treatment as usual.~   "
220249|NCT00675948|"~     The purpose of this study is to assess the safety and tolerability of long term therapy with~     Sativex® and GW-2000-02.~   "
220250|NCT00675935|"~     The goal of our project is to prevent patient falls by translating an individual patient's~     fall risk assessment into a decision support intervention that communicates fall risk status,~     and creates a tailored evidence-based plan of care that will be accessible to members of the~     care team to prevent falls.~   "
220251|NCT00675922|"~     Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound~     healing, length of hospital stay).~   "
220252|NCT00675909|"~     Lacerations (deep cuts) are a frequent cause of visits to emergency departments and~     laceration repair is one of the most common procedures performed in that setting. Children~     are often anxious when they visit the emergency department, and visits where they anticipate~     needing painful procedures can be particularly stressful. Though we can manage the pain~     associated with many minor procedures, we are frequently unable to adequately support the~     child and treat their problem if we don't manage their anxiety as well. Methods of calming~     that do not require medication (e.g. distraction, parental support) can help, but many~     patients still require sedative medications.~      The goal of sedation in the pediatric emergency department is to relieve the child's anxiety~     while minimizing the risk of adverse events. Unfortunately, when sedative medications are~     used in doses that do not slow breathing, they often fail to manage the child's anxiety~     adequately. In addition, many sedative agents require the placement of an intravenous line,~     which is itself a painful procedure that can create, rather than relieve, anxiety.~      Currently, there is no ideal sedative agent that is safe, effective, and easy to administer.~     Oral midazolam is one of the most commonly used sedative medications for laceration repair in~     children. In a dose of 0.5mg/kg it has been shown to be safe. Unfortunately, it provides~     adequate sedation in only about two thirds of patients and has a delayed onset of up to 20~     minutes. The remaining children must either endure the procedure in an agitated state or~     suffer placement of an intravenous line to administer additional sedative medications.~      We aim to find a method of providing sedation for laceration repair that has a higher success~     rate than oral midazolam as currently prescribed without increasing the risk of~     complications. We would like to evaluate new methods for administering midazolam using~     alternate routes and dosages. Previous studies have looked at the use of midazolam absorbed~     directly by mucous membranes such as inside the nose (intranasal) and inside the mouth~     (buccal). The use of intranasal midazolam has had some success especially given its rapid~     onset of action (about 5 minutes), but has been limited by the irritant effects of the drug.~     When placed in the mouth, many children swallow the drug or spit it out rather than allowing~     it to be absorbed by the mucous membrane. There has been some improved success when the drug~     was placed under the tongue, but this is typically difficult for young children. However, a~     new device called an atomizer has been developed that allows for improved intranasal and~     buccal administration. The atomizer has a small adapter placed on the end of a syringe,~     which spreads the medication out in a fine mist over a wide area. It can be sprayed in the~     mouth inside the cheek (buccal), avoiding the need to keep the medication under the tongue.~     While some pediatric institutions have already started giving midazolam with the atomizer,~     and are reporting anecdotal success with these methods, its safety and effectiveness have not~     been rigorously studied.~      We propose to compare three approaches to sedation: commonly used doses of oral midazolam,~     atomized intranasal midazolam and atomized intraoral midazolam. Children under the age of 7~     requiring sedation for wound repair will be eligible for enrollment. After informed consent,~     children will be randomized to one of the three methods described above. Their level of~     sedation will be determined using two scores validated for use in children (the sedation~     score and the modified CHEOPS score). Physician, nurse and parent impressions of sedation~     will also be compared.~      By comparing our current approach to these new methods, we will be able to determine which~     method is best. If we can identify a method for administering the sedative drug midazolam~     that is safe, well tolerated, and more effective, we will have made a valuable and important~     contribution to the care of injured children in the emergency department.~   "
220253|NCT00675896|"~     To compare the efficacy of Quetiapine SR versus placebo over 8 weeks in unipolar~     non-psychotic adult outpatients depression and comorbid fibromyalgia. This will be measured~     by the last observation carried forward (LOCF) mean change from baseline to week 8 on the~     Hamilton Depression Scale (HAM-D) total score.~      For the purposes of this study, response regarding improvement in depressive symptoms will be~     defined as a 50% decrease in HAM-D scores over 8 weeks. Furthermore, proportion of patients~     achieving remission is defined as an HAM-D total score of 7 at end of treatment. The anxiety~     comorbid symptoms often associated with major depression will be assessed with the HAM-A (14~     items) scale. Proportion of patients responding and achieving remission of anxiety symptoms~     are defined respectively as a reduction of 50% in the HAM-A total score from baseline and a~     HAM-A total score of 7 at the end of treatment.~   "
220254|NCT00675883|"~     A phase IV, observational, survey-based study to measure compliance with Avonex® PS therapy~     in patients with Relapsing-Remitting Multiple Sclerosis, and to compare persistence on~     therapy 22 months after initial prescription of AVONEX® PS between patients enrolled in the~     current MS AllianceTM program versus patients enrolled in this program prior to October 2007.~   "
220255|NCT00675870|"~     The purpose of this study is to determine whether NRX 195183 is effective in the treatment of~     relapsed or refractory Acute Promyelocytic Leukemia~   "
220258|NCT00675831|"~     The purpose of this research study is to evaluate the safety and efficacy of cell depletion~     in a donor lymphocyte infusion (DLI) product with the use of the CliniMACS machine.~     Previously, patients with hematologic malignancies who have relapsed after transplant have~     been given infusions of donor white blood cells calsed donor lymphocyte infusion (DLI) as a~     way to boost their immune function and fight cancer. Information from other research studies~     suggests that lowering the number of a certain type of white blood cell called CD25+ Tregs in~     the DLI may allow for a greater effect. In this research study, we are looking for the~     appropriate dose of DLI depleted of the CD25+ Treg white blood cells that can be given~     safely.~   "
220259|NCT00675818|"~     Acute kidney injury (AKI) in the intensive care unit is common, devastating and costly.~     However, minimal evidence exists to guide the prescription of optimal renal replacement~     therapy (RRT). An important area of uncertainty surrounds the relative effects of convective~     versus diffusive modes of clearance. Although both clearance modes provide similar degrees of~     small molecule clearance, convective modes permit the enhanced clearance of larger-sized~     molecules which may mediate kidney and systemic toxicity in the setting of AKI.~      Continuous renal replacement therapies (CRRTs) are frequently applied in critically ill~     patients with AKI. Convective clearance, as applied through continuous venovenous~     hemofiltration (CVVH) and diffusive clearance, as applied through continuous venovenous~     hemodialysis (CVVHD), may be readily compared in the context of patients receiving CRRT.~      The purpose of this study is to examine the feasibility of conducting a larger study that~     will determine whether convective clearance (hemofiltration) confers improved outcomes as~     compared to diffusive clearance (hemodialysis) in patients with AKI.~   "
220260|NCT00675805|"~     In patients treated with the monoclonal antibody infliximab (Remicade®) -which binds to and~     blocks tumor necrosis factor alpha (TNF-alpha) - an infusomat filter is routinely used to~     prevent the very same early adverse events observed in individuals receiving intravenous~     immunoglobulins (IVIG). We recently used such a filter in a patient suffering from malaise~     and vomiting in the context of an IVIG substitution therapy. In this patient symptoms~     improved and IVIG-induced complement-activation was reduced (unpublished observation).~      Based on this simple observation we hypothesize that this simple and approved filter-system~     may be efficient in retaining complement-activating immunoglobulin G (IgG) aggregates in~     IVIG-preparations. This effect may reduce complement activation - and consecutive~     inflammation - thereby diminishing adverse events.~      In this prospective study we propose to investigate how complement activation and side~     effects after IVIG infusion relate in individuals receiving conventional (i.e. unfiltered)~     vs. filtered IVIG-preparations.~   "
220261|NCT00675792|"~     The primary purpose of this study is to compare the incidence of~      residual neuromuscular blockade at the time of tracheal extubation after reversal of~     rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg~     neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch~     (T4/T1) ratio of~      < 0.90.~   "
220262|NCT00675779|"~     The purpose of this study is to determine whether atorvastatin (alone or in combination with~     oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in~     women with endometriosis.~   "
220263|NCT00675766|"~     While the numbers of HIV infected veterans under the age of 50 are declining, the percentage~     of HIV infected veterans over the age of 50 is increasing with the largest percentage~     increases in the 50-59 age group and the 70+ age group. With increasing incidence rates of~     new cases among individuals over 50 years of age and the longer life expectancies of the~     current HIV-infected population, it becomes increasingly important to better understand the~     impact of the aging process on the clinical and behavioral manifestations of HIV/AIDS.~      The project seeks to determine the effect of age on neuropsychological performance in HIV+~     persons. This objective seeks to determine the degree to which older age represents an~     independent risk factor for neuropsychological impairment in HIV infected persons, with a~     particular emphasis on those cognitive processes that are preferentially impacted by both the~     normal aging process as well as HIV infection. Additionally, another aim of the study is to~     determine the impact of neuropsychological decline on everyday functional abilities among~     older vs. younger HIV+ adults. This objective seeks to determine the effects of advancing age~     and neuropsychological impairment on the ability of HIV+ persons to discharge more demanding~     requirements of independent living (e.g., driving, financial management, medication~     adherence). The project will last for a duration of 5 years.~   "
220264|NCT00675753|"~     A multilocus interaction of three pro-inflammatory cytokine single nucleotide polymorphisms~     (SNPs), -3448 Tumor Necrosis Factor-α, -7227 Interleukin 6, and 33314 Interleukin 6R was~     reported by Menon and associates in 2006. The researchers reported that they were able to~     predict spontaneous preterm birth in 65.2% of a population restricted to European-American~     mothers. Expansion of this research is needed to determine if the results are also applicable~     in Black populations.~      Statement of Purpose The purpose of this research is to determine if the multi-locus genetic~     interaction of tumor necrosis factor-α (-3448), interleukin 6 (-7227), and interleukin 6R~     (33314), as described by Menon et al. (2006), is associated with preterm birth in Black~     mother-infant dyads.~      Research Aims and Hypotheses:~      Primary Aim 1.0: To determine if carriage of one of the high risk genetic patterns, as~     identified by Menon et al. (2006), is present in 65% of Black mothers with preterm births and~     35% of Black mothers with term births.~      Hypothesis 1.0: There is no statistically significant difference in the occurrence of one of~     the eight high risk genetic patterns, as identified by Menon et al. (2006), in a population~     of Black mothers with preterm births (case) and Black mothers with term births (controls).~      Primary Aim 2.0: To determine if carriage of one of the high risk genetic patterns, as~     identified by Menon et al. (2006), is present in 65% of Black preterm newborns and 35% of~     Black term newborns.~      Hypothesis 2.0: There is no statistically significant difference in the occurrence of one of~     the eight high risk genetic patterns, as identified by Menon et al. (2006), in a population~     of Black preterm newborns (case) and Black term newborns (controls).~   "
220265|NCT00675740|"~     The aim of this study is to prospectively assess the relative benefits of either treatment~     with rosiglitazone or physical exercise on endothelial function in patients with impaired~     fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).~   "
237830|NCT00442403|"~     This study aims to evaluate the safety and efficacy of a standard chloroquine drug regimen~     administration supplemented with dehydroepiandrosterone sulfate against drug-resistant~     malaria.~   "
220267|NCT00675714|"~     The purpose of the program is to study and characterize the outcome of burn injury with~     particular attention to improving the rehabilitation of burn survivors, including children.~     Various agents are assessed for effectiveness on long term burn outcome, such as growth~     hormone, oxandrolone, propranolol,ketoconazole, inhospital exercise and home exercise.~   "
220268|NCT00675701|"~     This is a Phase 1, double-blind, randomized, repeat-dose, single -dite, 4-arm parallel group~     study to define the ECG effect of lixivaptan using a therapeutic and supratherapeutic dose~     compared to placebo and moxifloxacin (a positive control in healthy adult men and women.~   "
220269|NCT00675688|"~     The purpose of this study is to determine whether bazedoxifene/conjugated estrogens~     combinations are effective for the prevention of endometrial hyperplasia and for the~     prevention of osteoporosis in postmenopausal women.~   "
220270|NCT00675675|"~     The study aims to clarify the functional anatomy of key brain circuits associated with~     cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare~     and contrast hypothesized mechanisms related to increased tic control associated with Habit~     Reversal Training, a behavioral treatment that been previously shown to be effective in~     treating CTD. We also seek to better understand the relationship between fMRI and~     quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and~     cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized~     to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of~     minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist~     nonresponders will be provided with 10 weeks of HRT. Study assessments, including a~     neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10,~     and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.~   "
220271|NCT00675662|"~     Randomised controlled trial of a lifestyle intervention programme for mothers and children~     aged 1-5 years aimed at prevention of overweight and obesity.~   "
220272|NCT00675649|"~     The purpose of this study is to assess the safety and effects (good and bad) of golimumab~     therapy in patients with severe, persistent asthma.~   "
220273|NCT00675636|"~     RATIONALE: Gathering medical and family history information from patients and family members~     may help doctors better understand hereditary colorectal cancer and hereditary polyposis~     syndrome and identify patients at high risk of developing hereditary colorectal cancer.~      PURPOSE: This research study is collecting information from patients and family members with~     hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing~     hereditary colorectal cancer.~   "
220274|NCT00675623|"~     The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and~     efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD).~   "
220275|NCT00675610|"~     The goal of this research is to improve communication between the patients with HIV and their~     health care providers. The overall purpose of doing so is to reduce disparities in medication~     self-efficacy, adherence to therapy, and HIV viral load suppression. The investigators will~     conduct a randomized controlled trial to test the effectiveness of a combined provider and~     patient communication intervention conducted at two separate visits compared to usual care in~     improving the quality of patient-provider communication, patients' medication self-efficacy,~     patient adherence to therapy, and HIV RNA suppression.~   "
220276|NCT00675597|"~     The purpose of this study is to determine whether a combination of the drugs docetaxel~     (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than~     cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.~      Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®),~     may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to~     receive bevacizumab.~   "
220277|NCT00675584|"~     Asthma affects about 4 million children in the United States and is a leading cause of~     hospitalizations and school absenteeism. Continuous wheezing in very young children may~     develop into asthma. Low doses of inhaled corticosteroids (ICS) are commonly prescribed to~     treat children with particularly bad wheezing episodes. This study will compare the safety~     and effectiveness of low doses of ICS taken daily versus higher doses of ICS taken only~     during respiratory tract illnesses for toddlers with continuous wheezing or coughing~     illnesses.~   "
220278|NCT00675558|"~     Despite progress in understanding the pathophysiology of obesity, current strategies for its~     medical management remain largely ineffective. Most efforts have focused on reducing caloric~     intake or increasing energy expenditure, either through behavior modification (e.g. dieting,~     regular exercise) alone, or augmented by pharmacologic efforts to decrease appetite, inhibit~     fat absorption, or alter metabolism. Bariatric surgery remains the only proven long term~     treatment of morbid obesity.~      Super morbidly obese (SMO: Body Mass Index (BMI) > 50) and super super morbidly obese (SSMO:~     BMI > 60) patients lose considerable weight, but stabilize at Body Mass Indexes (BMIs) that~     are still obese or even morbidly obese after risking considerable morbidity and/or mortality.~     Among commonly performed bariatric surgeries, a laparoscopic two-stage procedure, in which an~     initial restrictive procedure is followed after a weight loss of ~100 lbs by a more complex~     procedure that creates malabsorption, is gaining interest. Initial studies have demonstrated~     very good long-term weight loss with minimal morbidity, and no operative mortality in these~     high risk patients.~      Availability of biospecimens obtained at each stage of this protocol will allow participating~     scientists a unique opportunity to test in human tissues hypotheses developed in animals.~     Studies proposed under this application focus on fatty acids and overall fat disposition in~     fat depots (adipose tissue) of your body, and the role of adipose tissue hormones and~     inflammatory processes in obesity and its associated health related issues.~   "
220279|NCT00675545|"~     The primary objective is to determine the efficacy of docetaxel plus carboplatin as first~     line treatment in patients with hormone refractory prostate cancer.~   "
220313|NCT00675103|"~     The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24~     week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase~     i.v. was at least one year before study entry.~      This study is limited to four study centers in the US.~   "
220314|NCT00675090|"~     This is a safety and tolerability study to investigate the effect of GSK239512 on mild to~     moderate Alzheimers disease patients. The dose of GSK239512 will be titrated to reach the~     most well tolerated dose in the patients.~   "
220280|NCT00675532|"~     In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we~     will compare the efficacy of a primary care model of counseling (Condition 1) versus~     individualized cognitive-behavioral psychotherapy (Condition 2) for the treatment of opioid~     dependence. Treatment will last 12 weeks, and participants will be given 380mg of naltrexone~     per injection (3 injections in total; each lasting 4 weeks). Primary outcomes will be 1)~     percent of opioid negative urines and 2) treatment compliance as measured by attendance and~     time in treatment. Secondary outcomes are opiate craving, opiate withdrawal symptoms,~     perceived stress scores, severity of addiction problems, and patient satisfaction. Findings~     will elucidate whether injectable, long-acting naltrexone would be safe and effective in a~     primary care setting where medication would be administered in the absence of traditional~     cognitive-behavioral psychotherapy and indicate whether cognitive-behavioral psychotherapy~     adds to treatment effects above and beyond primary care counseling. If positive, this small~     controlled study will provide effect size estimates for a larger trial to assess Vivitrol ®~     in a primary care setting.~   "
220281|NCT00675519|"~     Compared with control participants at post-intervention follow-ups, unhealthy drinkers who~     receive the screening and brief intervention will (1) report reduced alcohol consumption~     among all patients, and (2) report reduced alcohol-related problems and health care~     utilization.~   "
220282|NCT00675506|"~     Obesity, a condition that occurs when a person has too much body fat, affects about 31% of~     people in the United States. It is associated with increased risk of diabetes, high blood~     pressure, high cholesterol, and cardiovascular disease. Abdominal obesity, in particular, is~     also associated with low levels of growth hormone, a hormone that affects rate of growth and~     the way the body uses energy. Growth hormone releasing hormone (GHRH) is a substance that~     makes the body naturally increase its own growth hormone levels. Administering GHRH to people~     who are obese may help return their growth hormone levels to normal and, in turn, may lead to~     reduced abdominal fat and improved cardiovascular function. This study will evaluate the~     effectiveness of synthetic GHRH in decreasing the amount of abdominal fat and improving~     cardiovascular function in people who are obese.~   "
220283|NCT00675493|"~     This trial is conducted in Europe. The aim of this observational study is to evaluate the~     blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes~     under normal clinical practice conditions in Romania.~   "
220284|NCT00675480|"~     The purpose of the study is to determine whether thrombus removal with aspiration~     thrombectomy for acute myocardial infarction reduces the infarct size.~   "
220285|NCT00675467|"~     The goal of this study is to learn about the communication, decision-making, symptom~     management, emotional adjustment, and spiritual needs of parents and pediatric patients~     treated at the Children's Cancer Hospital at M. D. Anderson (MCACC).~      Primary Objectives:~        1. Determine the palliative care service needs of pediatric cancer patients and their~          parents, including communication, decision-making, symptom management, emotional and~          spiritual support when receiving treatment for early cancer, treatment for advanced~          disease, and treatment in the end-of-life period.~        2. Identify intra-group differences in the categories listed in Objective 1 for pediatric~          cancer patients receiving treatment (a) for early cancer, (b) for advanced disease, and~          (c) at end-of-life.~      Secondary Objectives:~      1. Inform the development of a Pediatric Palliative Care Program at the Children's Cancer~     Hospital at The University of Texas M. D. Anderson Cancer Center (MCACC or MDACC) based on~     identified needs as determined by primary study aims 1 and 2.~   "
220286|NCT00675454|"~     Emphysema is a lung disease that involves damage to the air sacs in the lungs and can lead to~     breathing difficulties. Treatment options for people with emphysema include pulmonary~     rehabilitation, lung volume reduction surgery, and lung transplantation. This study will~     observe people with emphysema to assess the effect of these treatment therapies on their~     quality of life and long-term health.~   "
220287|NCT00675441|"~     The goal of this clinical research study is to learn if Revlimid® (lenalidomide), along with~     standard-of-care steroid treatment you are already receiving, can help to control Chronic~     Graft-Versus-Host Disease (cGVHD). The safety of this study drug in combination with the~     steroids will also be studied.~      Primary Objectives:~        -  To assess the response rate of chronic GVHD to Lenalidomide after failing steroids~        -  To evaluate the safety and tolerability of Lenalidomide in patients with chronic GVHD~      Secondary Objectives:~        -  To assess the steroid-sparing capacity of Lenalidomide (as proportion of patients able~          to discontinue steroids while receiving or following therapy with Lenalidomide)~        -  To assess changes in QOL after treatment with Lenalidomide~        -  To analyze survival at 6 and 12 months after initiation of Lenalidomide~        -  To evaluate relapse of underlying malignancy as well as second malignancies at 6 and 12~          months after initiation of Lenalidomide~   "
220288|NCT00675428|"~     The primary objectives of the study are to evaluate the safety profile and the anti-tumor~     activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple~     myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab~     in this study population and to assess peripheral blood mononuclear cell (PBMC) saturation of~     very late antigen-4 (VLA-4, an α4-integrin) and evaluate possible correlations with clinical~     activity.~   "
220289|NCT00675415|"~     Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In~     addition, capnography which measures carbon dioxide levels and can graphically assess~     respiratory activity will be used. Subjects will be randomized to either a capnography~     blinded or titration arm. In the capnography titration arm, the endoscopy team would be made~     aware of capnographic abnormalities as they arise throughout the procedure. In the~     capnography blinded arm, this information will not be available to the endoscopy team and~     represents standard of care. It is our hypothesis that using capnography can prevent low~     oxygen levels known as hypoxemia, during these procedures.~   "
220315|NCT00675077|"~     Huntington's disease (HD) is a fatal disease with profound neurological and behavioral~     features. HD is typically characterized by uncontrollable movements and psychological~     disturbances.~      This study will investigate the use of far infrared radiation for control, management and~     treatment of HD.~   "
220316|NCT00675064|"~     This study will examine safety of single doses of GSK369796 in healthy subjects, along with~     some test to examine how quickly GSK369796 gets in your blood, and how long it takes your~     body to get rid of it.~   "
220290|NCT00675402|"~     Given that previous studies demonstrated the feasibility of the required MRI techniques, we~     propose to study the macro- and microvascular adaptations in PAOD patients undergoing~     supervised exercise therapy. It is expected to provide valuable insights into the~     contribution of each vascular mechanism to the rehabilitation and to identify which vascular~     mechanism fails or is insufficient for a successful rehabilitation. Improvement of future~     treatment requires the identification of relevant adaptive mechanisms. With this we will~     provide early noninvasive MRI readout tools to diagnose and monitor the potential~     rehabilitation during any form of therapy for PAOD that affects the peripheral vasculature.~   "
220291|NCT00675389|"~     The provision of antiretroviral therapy (ART) in rural, resource-limited settings entails~     substantial challenges due to limitations in the health service infrastructure and in human~     resources for HIV/AIDS care. In addition, long geographical distances between providers, care~     facilities, and patients can represent a significant barrier to appropriate and timely care.~     The use of peer health workers as frontline adherence supporters and clinical monitors in~     order to improve care in underserviced settings has been implemented by a number of programs,~     but the effect of peer support on HIV care outcomes has not been extensively evaluated.~     Mobile phones have also been proposed as a potential method of improving access to health~     care in resource-limited environments by expediting communication and data transfer, but~     rigorous studies on their effectiveness in Africa have not yet been conducted.~      The Rakai Health Science Project (RHSP) was founded in 1987 to study the HIV epidemic in the~     rural setting of Rakai District in southwest Uganda. Since June 2004, the US President's Plan~     for AIDS Relief (PEPFAR) has enabled the RHSP to provide ART through a community-based~     distribution system which includes clinical monitoring via a decentralized, mobile clinic~     approach. By late 2006, the program has screened 4,397 HIV-infected individuals and initiated~     ART in 849 patients. One of the challenges of providing ART in this setting has been the~     distance between many patients' homes and the clinic and medical staff trained in HIV care.~     This distance and the lack of communication channels make frequent clinic contacts difficult~     and has raised concerns about adherence and management of drug toxicity. This study will~     investigate whether peer health workers can help support this AIDS care program and improve~     patient outcomes.~      This study is a three armed, community-randomized operations research trial to assess the~     effectiveness of peer health workers, with and without mobile phones, in improving the~     delivery of HIV care in the resource-limited Rakai setting. The three arms will be: a)~     communities with peer health workers, b) communities with peer health workers and mobile~     phones, and c) control communities without peer health workers.~      Study hypotheses include:~        -  Peer health workers, by supporting adherence and by managing simple clinical issues,~          will reduce virologic treatment failure and improve ARV adherence compared to patients~          in communities without peer educators.~        -  Mobile phone technology used by peer health workers, by more rapidly addressing~          adherence and clinical problems, will reduce treatment failure and improve adherence~          compared to patients in communities with peer health workers without mobile phones.~   "
220292|NCT00675376|"~     Most people undergoing lung transplantation have chronic obstructive pulmonary disease~     (COPD), a disease in which the lung airways are partly damaged and obstructed, making it~     difficult to breathe. This study will enroll people with COPD who are undergoing a lung~     transplant to examine how their quality of life changes after the transplant procedure.~   "
220293|NCT00675363|"~     The purpose of this study is to determine whether the use of both a nurse-driven sedation~     protocol and daily sedative interruption, compared with a sedation protocol alone, result in~     better outcomes for mechanically ventilated adults.~   "
220294|NCT00675350|"~     PK Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to~     Patients With Advanced Solid and Hematologic Tumors~   "
220295|NCT00675337|"~     This is a pilot study designed to assess the safety of placing an infant on the mother's~     abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of~     placing the infant on the mother's abdomen on the infant's iron stores. It is possible that~     placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron~     stores during early infancy.~   "
220296|NCT00675324|"~     Bowel preparation can be a troublesome procedure for patients undergoing colonoscopy. For~     patients with cardio-vascular and kidney disorders it may be dangerous with traditional bowel~     preparation with regard to salt and electrolyte balance. This study's purpose is to find out~     if nutritional drinks can replace traditional bowel preparation before colonoscopy in regard~     to Bowel purity degree, disturbances in the salt and electrolyte balance in the nutritional~     group versus the group that gets traditional bowel preparation. And if the patients tolerate~     nutritional drinks better than traditional bowel preparation.~   "
220297|NCT00675311|"~     The primary objective of this study is to determine whether remote monitoring in diabetes~     management is more effective at helping patients manage their disease than a standard disease~     management program.~   "
220298|NCT00675298|"~     Urologic pelvic pain syndrome (UCPPS), variably termed painful bladder syndrome/interstitial~     cystitis (PBS/IC) in females and chronic prostatitis/chronic pelvic pain syndrome in men~     (CP/CPPS), is a chronic, debilitating clinical syndrome presenting as severe pelvic pain with~     extreme urinary urgency and frequency in the absence of any known cause. The etiologic~     mechanisms underlying UCPPS are unknown, but recurrence, risks to siblings of affected~     individuals, concordance among monozygotic twins, and our own preliminary studies indicate a~     strong genetic contribution to the cause of UCPPS. The overall goal of this proposal is use~     novel approaches to understand the basis of UCPPS, to identify candidate genes containing~     mutations that result in UCPPS and determine how the different encoded proteins of these~     genes interact with one another in a common biological pathway. Ultimately, understanding how~     mutations in at least five different genes yield the symptoms of UCPPS should lead to~     improved diagnosis and possible therapies.~   "
220299|NCT00675285|"~     Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO)~     concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung~     function is unknown. We will aim to study the effect of treatment and withdrawal of~     montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in~     children with asthma.~      A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18~     atopic children with mild persistent asthma who will be treated with oral montelukast (5~     mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive~     matching placebo.~      A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.~   "
220300|NCT00675272|"~     Brain death patients who are selected for organ donation very often suffer from haemodynamic~     instability. To treat this, high amounts of vasoactive drugs(norepinephrine) may be needed to~     raise blood pressure. However,norepinephrine may have negative influence on several organs~     causing reduced blood flow ischemia. Our hypothesis is that hydrocortisone treatment may~     reduce the amount of vasoactive drugs needed to keep the blood pressure stable in patients~     selected for organ donation.~   "
220332|NCT00674856|"~     To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal~     function~   "
221828|NCT00655200|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino~     patients with Type 1 and Type 2 Diabetes Mellitus.~   "
220301|NCT00675259|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some find tumor cells and help kill~     them or carry tumor-killing substances to them. Others interfere with the ability of tumor~     cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking~     blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel~     albumin-stabilized nanoparticle formulation and carboplatin together with bevacizumab works~     in treating women undergoing surgery for stage II or stage III breast cancer.~   "
220302|NCT00675246|"~     This study aims to determine the effectiveness of antenatal corticosteroid therapy in late~     preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation~     even after 34 weeks and reduces risk of respiratory distress syndrome and other neonatal~     morbidities.~   "
220303|NCT00675233|"~     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is~     exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may~     be an effective treatment for laryngeal cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy~     when given together with HPPH in treating patients with dysplasia, cancer in situ, or~     invasive cancer of the larynx.~   "
220304|NCT00675220|"~     This study is conducted in Asia. The aim of this observational study is to collect efficacy~     and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as~     per normal clinical practice.~   "
220305|NCT00675207|"~     The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and~     brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy~     (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.~   "
220306|NCT00675194|"~     The purpose of this study is to determine which Arm (capecitabine + irinotecan versus~     capecitabine + cisplatin) shows higher response rates in the treatment of advanced~     gastric-oesophagal cancer~      Furthermore, comparison of progression-free survival, 1-year survival, Quality of Life and~     safety~   "
220307|NCT00675181|"~     Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the~     vasospastic syndrome (VS)?~      The main questions are:~      Do women with VS exhibit...~        -  a different basal metabolic rate~        -  a reduced choroidal blood flow~        -  a reduced increase of oxygen consumption after intake of ice-water~        -  a different oxygen consumption after melatonin intake~        -  a different choroidal blood flow after melatonin intake~        -  a different oxygen consumption after melatonin intake and after intake of ice-water….?~   "
220308|NCT00675168|"~     The prognosis of lung cancer depends much on the stage of the disease at the time of~     diagnosis. Only 16 % of lung cancer can be offered curative intended surgery. Chest x-ray is~     the gate-keeper in lung cancer diagnosis, but it has a miss rate of 20-60 %. A false negative~     chest x-ray often causes prolonged delay in diagnosis - often months.~      Recently a 48 hour diagnosis guaranty has been implemented, which helps accelerate the~     system delay (delay from referral to diagnosis). But chest x-ray is still the gate-keeper; if~     the chest x-ray is negative further examination ceases.~      PET/CT has a higher sensitivity (96 %), than chest x-ray. In the latter years only little~     improvement in the survival rate of lung cancer has been made. Screening studies is currently~     been performed, but it's time for innovative thinking. PET/CT has established its place in~     the staging of lung cancer. But studies like this may help to place PET/CT in the chain of~     examination making it more cost-beneficial.~      The overall aim of this study is to improve patient course with earlier diagnosis of lung~     cancer.~   "
220309|NCT00675155|"~     A stroke is a sudden loss of brain function. It is caused by the interruption of flow of~     blood to the brain (ischemic stroke) or the rupture of blood vessels in the brain~     (hemorrhagic stroke). This study will investigate the use of far infrared radiation for~     stroke rehabilitation.~   "
220310|NCT00675142|"~     The timing of IUI following ovulation induction has been the subject of many studies and a~     consensus has developed that a single insemination approximately thirty-six hours after~     ovulation induction is sufficien. The introduction of GnRH antagonists preventing a premature~     LH surge and early ovulation has added a new dimension to fertility treatment. It allows~     greater accuracy in predicting the timing of ovulation and has been shown to be at least as~     effective, if not more effective, as ovarian stimulation without antagonists. We hypothesize~     that by utilizing GnRH antagonists we can increase pregnancy rates during IUI by timing the~     IUI as close as possible to the moment of ovulation guaranteeing the highest and freshest~     concentration of motile spermatozoa in the fallopian tube at the time the oocyte is released~     from the ovary. We therefore propose a randomized open three arm prospective trial utilizing~     superovulation with GnRH antagonists whereby the IUI is timed to take place 36, 42 or 48~     hours after ovulation induction.~   "
220311|NCT00675129|"~     The purpose of the study is to evaluate the efficiency of dialectical behavior therapy (DBT)~     in treatment of adolescents with deliberate self harm compared to Enhanced Usual Care (EUC).~     Eighty patients in the age of 12-18 yrs old will be included in the study. The main inclusion~     criterion is repetitive deliberate self-harm. The patients will receive 16 weeks treatment in~     outpatient clinics in Oslo, after having been randomized to DBT or EUC. They will be assessed~     on five different time-points: baseline (before starting treatment), 6 weeks (after start of~     treatment), 12 weeks, 16 weeks and 68 weeks.~      The main study hypothesis is:~        -  DBT will be significantly more effective in treatment of self-harm behavior, as~          measured/indicated by reduction in number of self-harm episodes with or without intent~          to die, as well as reduction of number of emergency room visits.~        -  It is also hypothesized that DBT will significantly reduce the level of suicidal~          ideation and depressive symptoms compared to EUC.~   "
220312|NCT00675116|"~     This is a study to evaluate the safety, tolerability and pharmacokinetics of GW823296~     following 28 days, once-daily repeat oral doses.~   "
253738|NCT00230113|"~     The purpose of this study is to determine whether dietary supplementation with omega-3~     polyunsaturated fatty acids will decrease the amount of fat in liver.~   "
220317|NCT00675051|"~     Pulmonary hypertension is a progressive and life threatening condition. It is characterized~     by severe remodeling of the pulmonary vessel wall, obstructive plexiform lesions, multi-focal~     thrombosis, and enhanced vasoconstriction. All of these characteristics contribute to~     increased pulmonary vascular resistance.~      Circulating endothelial microparticles (EMPs) play an integral role in the pathogenesis and~     perpetuation of pulmonary hypertension. Levels of EMPs are considered a reliable biological~     parameter of endothelial injury.~      We propose to assess the evolution of both circulating and pulmonary venous EMPs in patients~     with PH. Assessments will be made before and after initiation of Endothelin-1 (ET-1) Receptor~     blocker therapy, and correlated to their patterns with the changes in mean PAP, the 6 Minutes~     Walking Distance test, and circulating Endothelin-1 values. Measurements of the endothelial~     microparticle circulating levels (assessed by flow cytometry methods) will be made before, 1~     month and 3 months after initiation of therapy.~   "
220318|NCT00675038|"~     Many hematological disorders are treated by giving red blood cells. Over a long period of~     time iron from the red blood cell will accumulate in the tissues of the heart, liver, and~     endocrine glands. This condition is referred to as iron overload and may become life~     threatening due to the effects of the iron on these tissues. The normal method for evaluation~     of iron overload is a liver biopsy. This procedure is invasive and has potential risks, such~     as bleeding and infection.~      It is very desirable to establish a method for assessing iron overload which is not invasive.~     New magnet resonance imaging (MRI) relaxation techniques (T2*MRI) can be used to indirectly~     assess the liver iron content and iron in the heart. Results of T2*MRIs show excellent~     correlation with liver iron content and heart function. The use of this method of assessment~     will minimize the risk and inconvenience of liver biopsy and possibly allow more frequent~     evaluations for iron overload, thus better treatment for these patients.~      Participants in this study will undergo both liver biopsy for liver iron content and T2* MRI~     of the liver and the heart. Results from the procedures performed in this study will be~     compared, with the end result being the possible elimination of invasive procedures to~     diagnose iron overload.~   "
220319|NCT00675025|"~     The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in~     children with Down syndrome who have finished the preceding 10-week, double-blind study of~     donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic~     visit.~   "
220320|NCT00675012|"~     The main objective of the trial is to document the safety of NGR-hTNF administered at low and~     high doses in combination with a standard oxaliplatin based regimen in patients with~     metastatic colorectal cancer not amenable to any clinical improvement by current standard~     treatments~   "
220321|NCT00674999|"~     To determine if Amnion, used on partial thickness burn injuries would provide an improvement~     in rate of healing, pain control and scarring as compared to standard medical treatments.~   "
220322|NCT00674986|"~     This randomized, parallel group study will determine whether the use of episodic, intensive~     glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive~     effect on overall glycemic control. Patients will be randomized into either the 'usual care'~     group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose~     analysis system. The effect of each treatment regimen on glycemic control will be assessed by~     measurement of change in baseline HbA1c values at 12 months. The anticipated time on study~     treatment is 1 year, and the target sample size is 504 individuals.~   "
220323|NCT00674973|"~     This study is designed to identify biomarkers which may predict improvement in progression~     free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who~     failed one prior regimen of standard chemotherapy or who are deemed unsuitable for~     chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient~     population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po~     daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study~     treatment is until disease progression, and the target sample size is 100-500 individuals.~   "
220324|NCT00674960|"~     Pick's disease, also known as Pick disease,or FTD is a rare fronto-temporal neurodegenerative~     disease. This study will investigate the use of far infrared radiation for the control,~     management and treatment of Pick's disease.~   "
220325|NCT00674947|"~     Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with~     relapsed or refractory solid tumors.~   "
220326|NCT00674934|"~     Multiple sclerosis (abbreviated MS) is an autoimmune condition in which the immune system~     attacks the central nervous system (CNS), leading to demyelination. This study will~     investigate the use of far infrared radiation for MS control, management and treatment.~   "
220327|NCT00674921|"~     According to the national guidelines in Uganda and to the World Health Organization~     guidelines, HIV-infected patients should receive cotrimoxazole prophylaxis indefinitely.~     There are, however, concerns regarding the indefinite application of cotrimoxazole~     prophylaxis among patients immunologically stabilized on HAART (e.g. high pill burden,~     drug-drug interactions, toxicity and poor adherence because of treatment fatigue). To date no~     empirical evidence is available regarding the safety and optimal timing for the cessation of~     cotrimoxazole prophylaxis among HAART patients who successfully restored immunological~     competence.~      Research question: Does morbidity significantly differ between continuation (orthodox) and~     cessation (experimental) of cotrimoxazole prophylaxis among immuno-competent patients stable~     HAART in the resource-limited setting of Uganda?~   "
220328|NCT00674908|"~     The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence~     of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib~     combination Vaccines) with single sequence of Shan 5 in infants.~   "
220329|NCT00674895|"~     Parkinson's disease (PD) is a degenerative disorder of the central nervous system that often~     impairs the sufferer's motor skills and speech. This study will investigate the use of far~     infrared radiation to manage, control and treat PD.~   "
220330|NCT00674882|"~     This protocol allows for ongoing data collection to assess the long-term clinical and~     psychosocial outcomes of pediatric patients who have received a hematopoietic stem cell~     transplant at St. Jude Children's Research Hospital.~   "
220331|NCT00674869|"~     This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants,~     in a current environmental context different from that of the seventies and eighties. It has~     a split mouth design. 4OO subjects are included and the duration of follow up is 2 years.~   "
220333|NCT00674843|"~     The muscular dystrophies (MD) are a group of more than 30 neuromuscular disorders that are~     characterized by progressive skeletal muscle weakness, defects in muscle proteins and the~     death of muscle cells and tissue. This study will investigate the use of far infrared~     radiation for managing muscular dystrophies.~   "
220334|NCT00674830|"~     The main goal of this population-based study is to assess the efficacy of two forms of~     cognitive-behavioral therapy (CBT) to treat various levels of insomnia symptoms in women with~     breast cancer: a professionally administered form and a patient self-administered form. It is~     hypothesized that the two treatment conditions will be associated with significantly greater~     improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of~     life, relative to the control condition (i.e., usual care). It is also hypothesized that the~     magnitude of effect sizes obtained in association with treatment at each time assessment will~     be greater for the professionally administered treatment than the self-administered~     treatment.~   "
220335|NCT00674817|"~     GSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and~     beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration.~     If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given~     once daily. The bronchodilatation after inhalation of single doses of GSK961081 alone and in~     the presence of the short acting beta agonist salbutamol and the short acting muscarinic~     antagonist, ipratropium bromide will be measured in this study. Any residual~     bronchodilatation post-inhalation of GSK961081 and demonstrated by addition of salbutamol or~     ipratropium bromide may provide an indirect assessment of the beta-agonist and antimuscarinic~     components of GSK961081~   "
220336|NCT00674804|"~     This study will investigate how patients are informed of their cancer diagnosis or recurrence~     and will explore their experience in learning about the diagnosis. Specifically, it will:~        -  Distinguish methods of telling the diagnosis and identify its relationship to the type~          of cancer.~        -  Determine if the way a patient is informed of their diagnosis is associated with their~          level of satisfaction with the method of being informed.~        -  Identify who informs the patient of their diagnosis..~        -  Determine patient satisfaction with their diagnostic consult.~        -  Identify indicators of satisfaction with the diagnostic consultation.~      Patients 18 years of age or older who are enrolled in or being screened for enrollment in a~     phase I, II or III clinical trial in the National Cancer Institute's Medical Oncology,~     Metabolism, Surgery or Neuro-Oncology branch may be eligible for this study.~      Participants complete a 15-minute questionnaire that includes questions related to the how~     they were informed of their cancer diagnosis.~   "
220337|NCT00674791|"~     This study will evaluate the safety and feasibility of administering a peptide vaccine~     consisting of twelve different tumor-rejection antigens to patients with high risk (TxN2-3M0)~     or metastatic breast cancer with no evidence of disease following their completion of~     systemic therapy. The vaccine is designed to elicit immune responses against twelve different~     pathways that are essential to tumor growth, survival and metastasis.~   "
220338|NCT00674778|"~     Previous randomised studies showed that radial artery catheterisation for percutaneous~     cardiovascular procedures has a superior safety profile than femoral access, however the~     confirmation of these benefits in the real world by a large, specific, observational study is~     still lacking.~      We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular~     procedure by designing a prospective registry monitoring a consecutive sample of patients in~     a short period of time at nine Roman hospitals reflecting the contemporary state of health~     care.~   "
220339|NCT00674765|"~     The purpose of this study is to examine the effects of quetiapine in reducing percent heavy~     drinking days and increasing percent abstinent days in alcohol dependent patients who are~     frequent heavy drinkers.~   "
220340|NCT00674752|"~     The purpose of this study is to assess the effect of gabapentin on polysomnographic~     assessments in transient insomnia induced by a sleep phase advance.~   "
220341|NCT00674739|"~     The purpose of this study is to determine whether imiquimod creams are effective in treating~     external genital warts (EGW). The secondary objective of this study is to provide information~     on recurrence of EGW. Additionally the study will also look at any adverse events associated~     with the use of the creams.~      External genital and perianal warts are caused by the infection of human papillomavirus or~     HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like~     small flesh-colored, pink, or red growths on or around the external skin of sex organs or~     perianal area. The warts may look similar to the small parts of a cauliflower or they may be~     very tiny and difficult to see. They often appear in clusters of three or four, and may grow~     and spread rapidly. They usually are not painful, although they may cause mild pain,~     bleeding, and itching.~   "
220342|NCT00674726|"~     The investigators are studying prospectively the difference in axilo-rectal temperature in~     patients with acute appendicitis and using as a control group patients consulting with acute~     gastroenteritis at our emergency unit.~   "
220343|NCT00674713|"~     The aim of the study is to investigate if P6 acupuncture made after induction of general~     anaesthesia might be effective for the prevention of PONV as ondansetron and if the~     acupuncture-ondansetron combination could enhance single therapy efficacy in patients~     undergoing laparoscopic cholecystectomy.~   "
220344|NCT00674700|"~     The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy~     (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared~     to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage~   "
220345|NCT00674687|"~     The purpose of this study is to assess the reproducibility and the effect of gabapentin on~     quantitative sensory testing assessments in neuropathic pain subjects.~   "
220346|NCT00674674|"~     1. To find the optimal dose of topotecan that can safely be given directly into the spinal~          fluid (called intrathecal administration) of children whose cancer has spread to the~          lining of the brain and/or spinal cord.~        2. To find out what effects (good and bad) topotecan has when given directly into the~          cerebrospinal fluid in children with neoplastic meningitis (cancer that has spread to~          the lining of the brain and spinal cord).~             -  Cerebrospinal fluid is the fluid that circulates around the brain and spinal cord.~        3. To determine if intrathecal topotecan is beneficial to patients.~        4. To better understand how topotecan is handled by the body after intrathecal~          administration.~        5. To evaluate the cerebrospinal fluid for signs (markers) of tumor spread.~   "
220348|NCT00674648|"~     The purpose of this study is to test the safety of a transfusion of specialized white cells~     from your transplant donor's blood, called T-cells, that have been grown and immunized~     against the CMV virus in the test tube. If the transplant donor is immune to CMV (ie: the~     donor has antibody to CMV in the blood), the T-cells will be selected and grown from the~     blood of the transplant donor. However, if the transplant donor is not immune to CMV, or if~     T-cells from the donor are not readily available, CMV-immune T-cells grown from the blood of~     another normal donor who is partially matched to the patients tissue type can be used. The~     transplant physician will explain which of these treatments is available to the patient.~      This trial is called a phase I trial because phase I trials are designed to test the safety~     of different doses of an experimental treatment. We want to find out what effects, good~     and/or bad, a dose/doses of these immune T-cells will have on the patient and on the CMV~     infection.~      Specifically, we wish to test CMV immune T-cells grown from your blood using a new method~     developed at our center. In this method, fragments of an important CMV protein, called~     CMVpp65, are chemically synthesized and then used to immunize T-cells in the test tube.~   "
220349|NCT00674635|"~     This is a randomized, double-blinded, placebo-controlled adaptive, dose finding study to~     investigate the safety, tolerability, PK, PD and efficacy of single and repeat intravenous~     infusions of GSK315243A in patients with active rheumatoid arthritis. The study is divided~     into 2 parts: Part A is an adaptive, dose finding phase which will provide safety,~     tolerability, PK and PD on single intravenous infusions. Part B is a repeat dose phase which~     will provide safety, tolerability, PK, PD and efficacy following repeat intravenous infusions~     of a selected dose level.~   "
220350|NCT00674622|"~     Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition~     affecting young and middle-aged adults-most commonly manual workers and recreational~     athletes. It results in significant pain and disability, limiting work productivity and an~     individual's ability to participate in and enjoy recreational activities. Like many other~     chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments,~     leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an~     irritant or proliferant solution into tendons, ligaments, and joints to treat chronic~     musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine~     the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we~     will seek to determine to what extent any beneficial effect of PrT is derived from deep~     needle placement vs. a specific effect of the injectate. The specific aims for this study~     are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for~     individuals with chronic LE; and 2) to determine whether the deep needle placement alone is~     responsible for the therapeutic effect, independent of injectate. In order to accomplish~     these aims, we will measure indicators of pain and disability using self-rating scales,~     questionnaires and physical measures. Subjects will be stratified prior to randomization on~     two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior~     6 months. If effective, subjects receiving PrT will show greater reduction of pain and~     functional impairment compared with the other two groups. This research will guide future~     studies on prolotherapy by determining what may be the best control condition. Additionally,~     further studies may explore the mechanism responsible for any beneficial effect.~   "
220351|NCT00674609|"~     The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in~     the management of subjects with intractable cancer-related pain.~   "
220352|NCT00674596|"~     Long pentraxin 3 (PTX3) is a recently discovered multimeric inflammatory mediator~     structurally linked to CRP and serum amyloid P-component. There is no data about the effects~     of Renin angiotensin system blockage (RAS) on PTX3 levels in diabetic patients with~     proteinuria. The aim of this study was to find out whether the beneficial effects of RAS~     blockage in diabetic proteinuria has any relation with the alteration of PTX3 levels. We~     searched for the effects of ACE inhibitor ramipril on the clinical and laboratory parameters~     of diabetic patients with proteinuria.~   "
220353|NCT00674583|"~     The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal~     vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine~     antibody response against meningococcal serogroup C disease.~   "
220354|NCT00674570|"~     This is a research study examining the use of two medications, Hydrocortisone and~     D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear~     responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder~     (PTSD). These responses will be tested using a fear learning and memory task administered by~     computer.~   "
220355|NCT00674557|"~     RATIONALE: Exemestane may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. ATN-224 may stop the growth of breast cancer by blocking blood flow~     to the tumor. It is not yet known whether giving exemestane together with ATN-224 is more~     effective than giving exemestane alone in treating patients with recurrent or advanced breast~     cancer.~      PURPOSE: This randomized phase II trial is studying the side effects of exemestane given~     together with or without ATN-224 and to see how well it works in treating postmenopausal~     women with recurrent or advanced breast cancer.~   "
220356|NCT00674544|"~     Childhood obesity and low fitness tracks into adulthood and carries significant~     co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel~     lifestyle intervention in preschool children in the French and German speaking part of~     Switzerland during one school-year results in a smaller increase in body mass index (BMI) and~     a larger increase in aerobic fitness.~   "
220357|NCT00674531|"~     Atherosclerosis is one of the first causes of morbidity-mortality in industrialized~     countries. Numerous works suggest that some infectious agents could be involved in the~     inflammatory process leading to the development of this pathology, such as Chlamydophila~     pneumoniae, cytomegalovirus or herpes simplex virus. Enteroviruses are small RNA viruses that~     have been incriminated in various acute or chronic cardiac diseases (pericarditis,~     myocarditis, dilated cardiomyopathy) and exhibit a tropism for vascular endothelia. Different~     clinical and experimental arguments suggest that they could play a cofactor role in the~     occurrence or maintenance of atherosclerosis lesions. A multicenter study developed in~     collaboration with colleagues of the University Hospital of Reims (France) showed that it was~     frequent to detect enterovirus RNA in cardiac biopsies from patients with myocardial~     infarction. Furthermore, a pilot study conducted in the University Hospital of Saint-Etienne~     (France) on atheromatous arterial samples from 18 patients allowed the detection of~     enterovirus RNA in 20% of them.~   "
220385|NCT00674167|"~     -  To assess the radiological response, curative resection rate of preoperative~          docetaxel/cisplatin/capecitabine(DCX).~        -  To correlate treatment response with serum RUNX3 promoter hypermethylation.~        -  To determine the toxicities of preoperative DCX~        -  To determine the time to progression/overall survival of preoperative DCX~   "
220386|NCT00674154|"~     The primary aim of the study is to assess whether 6-months of vitamin D supplements can~     decrease PTH compared with placebo treatment in primary hyperparathyroidism.~   "
220358|NCT00674518|"~     This study will compare three methods of counseling to determine which is most effective at~     motivating participants to adopt healthy lifestyle habits. The three methods are: individual~     counseling, working in groups with a health educator, and receiving advice from a physician.~     The health goals for subjects in this study are: 1) increase physical activity to 30 minutes~     each day, 2) reduce fat intake to less than 30% of total calories, 3) increase consumption of~     fruits and vegetables to at least 5 servings each day, and 4) reduce percentage of body fat~     to a healthy level.~   "
220359|NCT00674505|"~     To evaluate the procedural safety and filter efficiency of the FiberNet® Embolic Protection~     System when used in conjunction with the Boston Scientific Express SD Stent System for~     primary stenting of ostial atherosclerotic renal lesions in patients with atherosclerotic~     renal artery stenosis.~   "
220360|NCT00674492|"~     Qualitative pilot study of patients' views of their experience with antiviral treatment for~     hepatitis C.~   "
220361|NCT00674479|"~     The goal of this clinical research study is to learn if ruxolitinib can help to control~     advanced hematological malignancies. The safety of this drug will also be studied.~   "
220362|NCT00674466|"~     This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The~     objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with~     CJC-1134-PC in patients who are currently on metformin monotherapy.~   "
220363|NCT00674453|"~     The objective of the study is to demonstrate the effects that lasofoxifene has on serum~     markers of bone metabolism.~   "
220364|NCT00674440|"~     Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these~     children may require surgery. In this study, researchers affiliated with the University of~     Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of~     hyperinsulinism that may be cured by surgery. Eligible participants in this study will have~     positron emission tomography (PET) scans with F-DOPA prior to surgery.~   "
220365|NCT00674427|"~     This study is for patients with relapsed of disease after allogeneic bone marrow~      The donor's T cells are activated by exposure to 2 compounds or antibodies that bind (or~     stick to) two compounds on T cells called CD3 and CD28. When these antibodies stick to both~     CD3 and CD28 on the T cells, the T cells becomes stimulated (or activated) and grows. CD3~     and CD28 are the coating of a T cell and a T cell is part of the body's immune system.~      It is believed that when T cells are exposed to both of antibodies to CD3 and CD28 compounds~     at the same time, they become activated or stimulated and may be more effective in fighting~     infections or cancer cells. We call this therapy activated donor lymphocyte infusions, or~     activated DLI (aDLI).~      This current study is being performed to see whether it is safe and effective to administer~     higher doses of activated DLI or repeated doses of activated DLI.~      All patients will receive standard donor lymphocyte infusions first, and in addition will~     receive activated donor lymphocytes approximately 12 days later (DLI followed by aDLI).~     Depending on the response to this treatment, and depending on possible side effects (such as~     graft-vs-host disease as described below), patients in remission will then receive additional~     aDLI every 3 months for 4 more times, and patients not in remission within 6-12 weeks will~     receive higher dose aDLI. The timing of the higher dose aDLI will be determined by your~     physician depending on your disease and the rate of progression of your disease. The aDLI can~     be given as early as 6 weeks, or as late as 12 weeks (3 months).~   "
220366|NCT00674414|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow~     to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more~     effective than giving trastuzumab alone in treating women with breast cancer.~      PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how~     well they work compared to trastuzumab alone before surgery in treating patients with breast~     cancer that can be removed by surgery.~   "
220367|NCT00674401|"~     The purpose of this study is to assess the value of ablation of high frequency sources~     following circumferential pulmonary veins isolation in patients with paroxysmal and~     persistent atrial fibrillation.~   "
220368|NCT00674388|"~     The Study is designed to collect information about adverse events that occur in children~     undergoing anesthesia in participating hospitals. Demographic information will be collected~     on all anesthetics. An analysis of each adverse event will be performed and entered into the~     database. From this information we will devise strategies to prevent these adverse events.~   "
220369|NCT00674375|"~     The evaluation of chest pain in the primary care office is a challenging problem, with many~     patients suffering from missed diagnoses of acute myocardial infarction and many other low~     risk patients receiving unnecessary evaluations. This project will provide primary care~     physicians evaluating patients complaining of chest pain with computerized alerts that~     differentiate high-risk patients from low risk patients, and provide individualized~     evaluation and treatment recommendations.~   "
220370|NCT00674362|"~     To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with~     stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission~     in patients with moderate to low disease activity rheumatoid arthritis~   "
220387|NCT00674141|"~     The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in~     relapsing MS patients~   "
220388|NCT00674128|"~     The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as~     effective as polyglactin 910 suture for surgical closure of cardiac device pockets.~   "
220389|NCT00674115|"~     Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to~     compare effects on stomach acid; 30 participants will continue treatment for 7 days and will~     have repeat evaluations at Day 7. The other 30 participants will receive a single~     administration of sodium bicarbonate.~   "
220390|NCT00674102|"~     The safety, tolerability, efficacy and pharmacokinetics of ASA404 when administered in~     combination with paclitaxel and Carboplatin are assessed. ASA404 is administered~     intravenously every 21 days to Japanese patients with Non small cell lung cancer.~   "
220391|NCT00674089|"~     Vitamin A is an essential micronutrient for the normal functioning of the visual system,~     growth and development, immunity and reproduction. Its deficiency causes anemia, growth~     retardation and xerophthalmia. Vitamin A deficiency also increases the incidence and/or~     severity of infectious episodes and affects child survival. Reduced child survival is the~     most severe and potentially the most widespread consequence of Vitamin A deficiency.~     Improvement in vitamin A status is now regarded as one of the most cost effective preventive~     measures for the reduction of child mortality and morbidity.~      Over the past decade several studies have examined the effect of vitamin A on reducing~     mortality among children aged ≥6months at the time of intervention. Impact of vitamin A~     supplementation can significantly reduce total mortality but it is only established through~     supplementation programs in children age 6 months or older. It was assumed that breast milk~     protects infants from vitamin A deficiency, but recent evidence has challenged this. Infants~     born with low stores of vitamin A and if the mother breast milk has a low concentration of~     vitamin A, as found in developing countries, the infants might be unable to meet their daily~     requirements and improve body reserves. There is association between mortality and degree of~     vitamin A deficiency, greater the degree of deficiency, higher the mortality.~      The role of vitamin A in child survival is now well established and over 60 countries have~     vitamin A supplementation programs nationally. However, most are still using vitamin A~     supplements in the second half of infancy, even though over 75% of all under 5 deaths take~     place in the first 6 months of life. If neonatal vitamin A supplementation can be found to be~     effective and a service delivery mechanism also found, this will represent a major advance in~     reaching the MDG 4 targets. This is thus persuasive reason to explore this particular~     preventive strategy, especially in terms of packaging with other postnatal care activities.~     However, given that in some instances it has been difficult to disentangle the effect of~     vitamin A dosing from concomitant vaccinations such as BCG, the current evidence needs~     further evaluation in effectiveness settings. We propose to evaluate the effectiveness of~     early neonatal vitamin A administration (single dose 50,000 units) to the newborn to see its~     effect on infant mortality less than 6 months of age as part of postnatal package through~     National Program.~      Government has launched the National Program for Family Planning and Primary Health Care~     since April 1994. Primarily it is being implemented in the community through Lady Health~     Workers (LHWs) of the National Program.~      The LHWs are females, with a minimum of eight years of education, residents of the locality~     in which they are working. The Programme is being currently implemented in all the districts~     throughout the country and 93,000 LHWs are working covering primarily women and children of~     the rural population. These LHWs deliver services related to family planning, maternal and~     child health, immunization, nutrition and treatment of minor ailments to her average~     registered population of 100-150 households or ~1000 population. Over 3,000 Supervisors have~     been recruited and trained to supervise the work of LHWs.~   "
220371|NCT00674349|"~     Ovarian cancer is the first mortality rate of gynecologic malignancies. The incidence of~     ovarian cancer increased in recent 10 years and it has become the ninth cause of malignancies~     in the women in Taiwan. From the above-mentioned data, ovarian cancer indeed is a disease~     that should be respected, however, there were only few of research work focusing on it in~     Taiwan. Despite the widespread use of aggressive cytoreductive surgery and the introduction~     of chemotherapy regimens, the overall survival has changed little over the last two decades.~     The basic problem in treating epithelial ovarian cancer is that once it has spread beyond the~     ovary, it is exceedingly difficult to control and ultimately to cure. More than 70% of~     ovarian cancer patients were advanced stage when diagnosed. To study the mechanisms of~     carcinogenesis, progression, and metastasis of ovarian cancer will help us understand this~     disease and develop new treatment strategies for ovarian cancer in the future.~      We have established an ascitogenic itnraperitoneal tumor cell line-WF3 in the mouse model in~     our previous two-year project of NSC grant (grant number (NSC90-2314-B-002-457 and~     NSC91-2341-B-002-315). Our group found that, mesothelin, this molecule is highly related with~     the carcinogenesis, tumor progression and tumor metastasis in our animal model and human~     cancer tissues. To further evaluate the role of mesothelin in ovarian cancer and elucidate~     the potential of mesothelin as a target antigen for immunotherapy,~   "
220372|NCT00674336|"~     Norwalk virus and related Norwalk-like viruses are the most common cause of outbreaks of~     stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United~     States. These viruses are sometimes found in drinking water, ice, shellfish and in other~     foods. They can be spread easily from contact with water, food, objects or hands that have~     even small amounts of feces from someone who was sick.~      The purpose of this research study is to the effectiveness of high hydrostatic pressures~     processing (HPP) treatment on norovirus infected shellfish. Norwalk virus can survive in~     shellfish and still be able to cause sickness. HPP inactivates microorganisms living both on~     the surface and on the interior of the food. The goal of the study is to determine whether~     HPP treatment on oysters spiked with norovirus will reduce infection rates in people~     consuming raw infected oysters.~   "
220373|NCT00674323|"~     This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination~     treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving~     complete regression of polyps in patients with symptomatic macular polypoidal choroidal~     vasculopathy.~   "
220374|NCT00674310|"~     The objective of this study was to assess the single dose bioequivalence of Roxane's~     Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions~     using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.~   "
220375|NCT00674297|"~     The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and~     safe in reducing the risk of cardiovascular disease and blood clots in patients with~     antiphospholipid antibodies or Antiphospholipid Syndrome (APS).~   "
220376|NCT00674284|"~     We study the relationship between patient outcomes and sequential changes of serum cortisol~     level.~   "
220377|NCT00674271|"~     The aim of this study is to investigate the relation between individual differences in~     pattern recognition molecules (PRM's) in the innate immune system and the prevalence and~     development of vascular complications in patients with type 2 diabetes.~      This is based on the hypothesis that pattern recognition molecules (PRM's) in the innate~     immune system contributes to a chronic low grade inflammation in diabetic patients. Variation~     in PRM's - at the genome, proteome as well as the functional level - are therefore associated~     with the degree of chronic low grade inflammation, and probably also with the prevalence of~     vascular complications.~   "
220378|NCT00674258|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402~     restricted epitope peptides URLC10, TTK and KOC1 emulsified with Montanide ISA 51.~   "
220379|NCT00674245|"~     The purpose of this research study is to determine if treatment with pantoprazole 40 mg daily~     versus a placebo improves sleep quality in patients with gastroesophageal reflux disease~     (GERD). Another purpose is to determine if treatment with pantoprazole 40 mg once daily~     versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease~     using spectral analysis of sleep electroencephalogram (EEG).~   "
220380|NCT00674232|"~     This study aims to compare the efficacy, side effects profile and acceptability of a single~     dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local~     protocols for the treatment of incomplete abortion.~   "
220381|NCT00674219|"~     The objective of this study was to obtain preliminary open-label data on the efficacy and~     tolerability of memantine, an anti-glutamatergic medication with a unique pharmacodynamic~     profile, in individuals with OCD and individuals with GAD. Because glutamatergic~     hyperactivity in frontal and frontal-subcortical circuits may play a role in the symptomatic~     expression of OCD, and possibly GAD, agents that reduce glutamatergic neurotransmission~     should provide unique anti-stress and anti-obsessional benefits. Memantine is a specific,~     uncompetitive antagonist at the NMDA receptor that blocks sustained activation of the NMDA~     receptor by high concentrations of glutamate under pathological conditions but rapidly leaves~     the NMDA channel upon transient physiological activation by low concentrations of glutamate.~   "
220382|NCT00674206|"~     The purpose of this study is to investigate if the combination of gemcitabine and oxaliplatin~     is effective for triple negative breast cancer.~   "
220383|NCT00674193|"~     This laboratory study is evaluating how well dactinomycin and vincristine work in treating~     young patients with cancer. Studying samples of blood and urine in the laboratory from~     patients with cancer may help doctors learn how dactinomycin and vincristine affect the body~     and how patients will respond to treatment.~   "
220384|NCT00674180|"~     This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in~     2001 that evaluated the costs and effects of incremental components of a weight-loss program.~     Data analysis will involve cross-sectional and predictive analyses and may include:~     regression analyses to determine predictors of weight loss and cardiovascular risk,~     correlations between weight reduction strategies and biological indices, and interactions~     between biomarkers of inflammation and traditional cardiovascular risk factors. This data~     will also be available for economic modeling.~   "
224529|NCT00619541|"~     The purpose of this study is to use Sorafenib + 5-FU to evaluate activity, efficacy, safety,~     pharmacodynamics (PD) and pharmacokinetics (PK) in patients with advanced hepatocellular~     carcinoma (HCC).~   "
220395|NCT00674037|"~     Patients' recruitment is difficult in clinical trial. Financial incentives are frequently~     proposed to clinicians in private funded trials. However, the effect of these financial~     incentives has never been evaluated.~      The purpose of this study is to evaluate the effect of financial incentive on the rate of~     recruitment of patients in a cohort study.~   "
220396|NCT00674024|"~     Background:~        -  Pazopanib is an experimental drug that was designed to enter cancer cells and block the~          activity of proteins that are important for cancer cell growth and survival.~        -  This is the first study in which pazopanib is given to patients with different degrees~          of liver function. The safe dose for patients with normal liver function is already~          known.~      Objectives:~        -  To determine the safety and side effects of pazopanib given at different dose levels to~          patients with cancer who have different degrees of liver function.~        -  To find out how much pazopanib is in the blood at specific times.~        -  To determine if pazopanib is effective in treating advanced cancer in patients with~          different degrees of liver function.~      Eligibility:~      - Patients 18 years of age and older with an advanced solid tumor or lymphoma that cannot be~     treated successfully with standard therapies and who have normal or abnormal liver function.~      Design:~        -  Treatment:~        -  Patients are divided into 4 groups, based on their liver function. The first three~          patients in each group receive a low dose of pazopanib. The next three in each group~          receive a higher dose of pazopanib if no serious side effects were reported in the~          previous three. The dose is increased in succeeding groups of three patients until the~          maximum study dose is reached.~        -  Patients take pazopanib once a day by mouth in 21-day treatment cycles. Treatment~          continues until the cancer worsens, the patient develops severe side effects, the~          patient no longer wants to continue the study, or the doctor removes the patient from~          the study for other reasons.~        -  Monitoring:~        -  Blood pressure: Patients monitor and record their blood pressure twice a day after~          starting treatment.~        -  Blood tests: Patients have weekly routine blood tests. In addition, at week 3 of the~          first cycle and again after the highest safe dose has been determined, several blood~          samples are collected at frequent intervals to determine how the body handles the drug.~        -  Imaging studies: X-rays or scans or both are done to measure the extent of disease every~          3 cycles.~        -  Physical examinations are done at periodic intervals.~   "
220397|NCT00674011|"~     This research study will look at the effect of an anti-angiogenesis medication called~     Bevacizumab on blood vessels. Anti-angiogenesis medicines fight cancer by cutting off a~     tumor's blood supply, starving the tumor of nutrients and oxygen. Previous studies have shown~     these types of drugs can cause hypertension. The purpose of this study is to help researchers~     better understand why these drugs cause hypertension. This information will assist~     researchers in learning how to control this side effect.~   "
220398|NCT00673998|"~     An age-related decrease in muscular strength may have a detrimental effect on muscle fatigue~     and recovery. To date, only one study has determined the effect of varied rest intervals (RI)~     between exercise sets in active younger and older women. They reported that active younger~     and older women require similar RI between sets to recovery full isokinetic knee extension~     peak torque (PT). However, we are unaware of any published studies comparing RI PT recovery~     between younger and older men. Thus, the purpose of this study was to compare the effect of~     two different RI's between sets of isokinetic knee extension exercise on PT, and Total Work~     (TW) between untrained younger and older men.~   "
220399|NCT00673985|"~     The main objective of this study is to assess the safety and effectiveness of the Edwards~     Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the~     treatment of occlusive superficial femoral artery (SFA) disease by reducing the~     re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone~   "
220400|NCT00673972|"~     The purpose of this study is to compare postprandial distress syndrome and epigastric pain~     syndrome in demographics psychological features, infection of Helicobacter pylori, gastric~     emptying and therapeutic response to lansoprazole.~   "
220401|NCT00673959|"~     To evaluate the acute comfort and blurring profile between two artificial tears products in~     dry eye patients~   "
220402|NCT00673946|"~     To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute~     bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within~     72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage~     points above the true measurements is significantly lower in comparison to those whose~     monitors display true saturations.~   "
220403|NCT00673933|"~     In this multicenter study, patients with dark skin and acne vulgaris will be included. The~     patients will receive treatment with MAL PDT and placebo PDT.~   "
220404|NCT00673920|"~     This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in~     patients with active rheumatoid arthritis who have an inadequate response to methotrexate~     therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on~     Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3)~     infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment~     period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a~     single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2~     will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a~     stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated~     time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial~     is 300.~   "
220405|NCT00673907|"~     The study intends to focus on health effects and symptoms related to particle exposure from~     wood burning stoves~      The objective is to determine whether moderate exposure to particles from wood smoke in a~     real life situation causes an systemic inflammatory response in peripheral blood or in lower~     airways. 24 healthy subjects (normal healthy subjects and mild asthmatics to study the~     asthmatic response) is selected for the study. A randomized double blind crossover procedure~     will be followed with a PM exposure concentration of 200ug/m3, 400ug/m3 or clean air as the~     control exposure. Exposure will take place in a climate chamber using wood burning in an~     appropriate wood stove.~   "
220406|NCT00673894|"~     This study will investigate the effect of glutamine, an amino acid, on GLP-1, insulin and~     glycaemia in normal lean subjects and patients with type 2 diabetes.~   "
220407|NCT00673881|"~     The objectives of the study are:~        1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT~          (reverse cholesterol transport) in men and post-menopausal women diagnosed with~          dyslipidemia (i.e., low high-density lipoprotein [HDL] cholesterol levels and elevated~          triglyceride [TG] concentrations).~        2. To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL.~        3. To obtain pilot data for power calculations for subsequent comparative study.~   "
220408|NCT00673868|"~     This study examines the immunologic and virologic effects of prophylactic CMV specific CTL in~     recipients of T cell depleted stem cell transplant (TCD SCT) at Duke University Medical~     Center (DUMC), by measuring levels of CMV DNA and virus specific T cell precursors at~     intervals post-infusion.~   "
220409|NCT00673855|"~     To evaluate the acute comfort and blurring profile between two artificial tears in dry eye~     patients.~   "
220411|NCT00673829|"~     The purpose of this study is to collect data on the safety and effectiveness of 2nd~     generation designer T cells in patients with breast cancer. Designer T cells are prepared by~     collecting white blood cells from the participant, and then modifying these cells in the~     laboratory so that they recognize the tumor antigen (CEA). These modified cells are then~     given back to the participant so that they can attack and kill tumor cells.~   "
220412|NCT00673816|"~     This open-label study will pilot the use of systemic sunitinib malate, a dual inhibitor of~     vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF), in five~     participants with Von Hippel-Lindau (VHL) to investigate its potential efficacy as a~     treatment for retinal angiomas. Participants will have visual dysfunction with either visual~     acuity loss or visual field loss from retinal angiomas secondary to genetically confirmed~     VHL. This open-label study will pilot the use of systemic sunitinib malate in five~     participants to investigate its potential efficacy as a treatment for retinal angiomas~     associated with VHL. Participants will receive nine months of sunitinib malate therapy (six~     cycles total - one cycle consists of 50 mg oral dose once daily for four weeks followed by a~     two week rest period). The primary outcome will be a change in the best-corrected visual~     acuity of more than or equal to 15 letters from baseline to the Week 36 visit. The secondary~     ocular outcomes will focus on retinal thickness and leakage of the retinal angioma at the~     Week 36 visit. Optical coherence tomography will document changes in retinal thickening and~     fluorescein angiography will be used to determine leakage of the retinal angioma.~   "
220413|NCT00673803|"~     Studies showed that a sharp posterior optic edge of an intraocular lens (IOL) inhibits~     migration of lens epithelial cells in between posterior capsule and optic of the IOL and~     therefore reduces the rate of posterior capsule opacification (PCO). In present time most~     IOLs implanted have a sharp posterior optic edge. Due to differences in IOL production~     different IOLs have different rates of PCO.~      Progression in cataract surgery technique allow phacoemulsification through micro-incisions.~     Therefore there is need for IOLs that can be implanted through incisions of about 2.5 mm.~      This study investigates the effect of two different hydrophobic acrylic IOLs with a sharp~     posterior optic edge on the rate of PCO after implantation through a micro-incision. The~     results will be compared intraindividually.~   "
220414|NCT00673790|"~     This study is being done to see if the blood pressure and metabolic effects of an approved~     drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and~     placebo in hypertensive patients.~   "
220415|NCT00673777|"~     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201~     restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.~   "
220416|NCT00673764|"~     To evaluate the effect of 2 different lubricant eye drops on visual function of patients with~     dry eye~   "
220417|NCT00673751|"~     The aim of the study is to investigate the effect of the enteric hormone Glucagon-like~     Peptide (GLP-2) on patients with short bowel syndrome~   "
220418|NCT00673738|"~     This research is being done to find out if a treatment consisting of a combination of~     thoracic radiotherapy with cetuximab, given together, and followed by chemotherapy with~     docetaxel and cetuximab (also given together) will kill the cancer cells in the patient's~     body and shrink the size of their tumor without causing unacceptable side effects. This may~     allow patients to live longer or decrease the frequency and/or severity of the symptoms~     caused by the cancer without increasing the frequency and/or severity of the symptoms caused~     by the treatment.~   "
220419|NCT00673725|"~     To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD~   "
220420|NCT00673712|"~     The main goals of the study are as follows: (1) to determine the correlation between pain~     management using continuous infusion of local anesthetics and the incidence of pneumonia and~     surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between~     hospital-acquired pneumonia and surgical infection and patient outcomes, including length of~     hospital stay.~   "
220421|NCT00673699|"~     The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can~     detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in~     case of suspected intestinal metaplasia~   "
220422|NCT00673686|"~     In this study a comparison was made on the influence of missing pills on follicular ripening.~     By missing a given number of pills, an effect on contraceptive robustness of the two~     investigated contraceptive pills was measured by ultrasound comparison of follicular size and~     other parameters which indicate how far ovulation might be.~   "
220423|NCT00673673|"~     This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of~     FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or~     unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to~     determine the time to progression in patients treated with FOLFOX in combination with~     bevacizumab.~   "
220424|NCT00673660|"~     The purpose of the study is to show the compliance rates of the patients to statin treatment~     and the reasons of non-compliance.~   "
220425|NCT00673647|"~     The purpose of this study is to evaluate the effectiveness of the cognitive-behavioral~     treatment program CANDIS among n=450 patients with cannabis use disorders in a mulicenter~     randomized-controlled clinical trial (n=11 outpatient treatment centers).~   "
220426|NCT00673634|"~     The purpose of this clinical trial is to evaluate whether pre-oxygenation of obese patients~     with BiPAP 4cm H2O, renders any benefit to the quality of pre-oxygenation measured by the~     expired oxygen fraction (FeO2) and whether it is as well tolerated as the traditional method~     of spontaneous breathing for 3 minutes.~   "
220427|NCT00673621|"~     This study will compare the rate and extent of absorption of TI Inhalation Powder in subjects~     with asthma and subjects with normal lung function. 24 eligible subjects will be enrolled~     into the treatment phase of the trial.~   "
220428|NCT00673608|"~     This study will evaluate the change in cardiac iron load over a 53 week period measured by~     MRI in 2 cohorts of patients~   "
220447|NCT00673361|"~     This research study is testing the chemo-switch strategy in melanoma, using biochemotherapy~     initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide)~     together with sorafenib. The purpose of this study is to find out what effects (good and bad)~     biochemotherapy followed by temozolomide plus sorafenib have on melanoma.~   "
220429|NCT00673595|"~     The purpose of this study is to evaluate endothelial function and autonomic regulation (for~     example, heart rate and blood pressure) in smokers before and after short-term smoking~     cessation. The endothelium is the thin layer of cells that lines the interior surface of~     blood vessels. The endothelium releases nitric oxide, which promotes dilation of the blood~     vessels and inhibits inflammation. Previous studies have shown that tobacco use is associated~     with endothelial dysfunction, and tobacco use increases heart rate and blood pressure.~      We hypothesize that 2 weeks of smoking cessation will improve endothelial function. We will~     also determine if endothelial function and autonomic regulation after short-term smoking~     cessation differs for patients that achieve abstinence with the smoking cessation agent~     varenicline compared to placebo.~   "
220430|NCT00673582|"~     Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular~     benefits. The goal of this project is to determine if rosuvastatin is effective at slowing~     the development of heart disease in people with HIV. We expect that after 2 years of~     treatment people treated with rosuvastatin will show significantly better results than people~     treated with a placebo.~   "
220431|NCT00673569|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that may occur in DNA and identify biomarkers related~     to cancer. It may also help doctors learn how well patients will respond to treatment.~      PURPOSE: This phase II trial is studying how well a laboratory test predicts response to~     erlotinib in patients with metastatic or unresectable non-small cell lung cancer that did not~     respond to previous treatment.~   "
220432|NCT00673556|"~     To assess the efficacy and safety of Alefacept compared to placebo for the treatment of~     Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and~     inappropriate~   "
220433|NCT00673543|"~     Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The~     administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in~     women at risk for preterm birth. The purpose of this study is to compare the timing, duration~     and severity of maternal hyperglycemia after corticosteroid administration in women with~     insulin-requiring diabetes compared to those without diabetes in pregnancy.~      This is a prospective, observational study. Hourly glucose levels will be obtained for a~     total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose~     monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level~     of glycemic control of the participant prior to the corticosteroid therapy.~   "
220434|NCT00673530|"~     The purpose of this study is to determine whether there is a positive correlation between an~     evidence based clinical nutrition concept and relevant clinical outcomes in malnourished~     hospitalised patients when severity of disease is adjusted.~   "
220435|NCT00673517|"~     Although mechanical ventilation is life saving, it is associated with a number of severe~     complications collectively referred to as ventilator induced lung injury (VILI). VILI~     contributes to the high morbidity and mortality associated with the acute respiratory~     distress syndrome (ARDS). Within the context of a randomized study evaluating the feasibility~     of conducting a study comparing high frequency oscillation to conventional lung protective~     ventilation in early severe ARDS, we are evaluating the effect of both ventilator strategies~     on biological markers of VILI.~   "
220436|NCT00673504|"~     Primary objective: to evaluate whether the addition of sunitinib prolongates the~     Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving~     first-line gemcitabine chemotherapy.~   "
220437|NCT00673491|"~     The purposes of this study are to determine whether clinical pathways: 1)improve the quality~     of the care provided to patients affected by stroke in terms of clinical outcomes, efficiency~     continuity of care and patients' satisfaction; 2) facilitate the use of evidence based~     medicine in clinical practice.~   "
220438|NCT00673478|"~     The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic~     exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus~     tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic~     obstructive pulmonary disease (COPD).~   "
220439|NCT00673465|"~     The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and~     to determine the influence of race/ethnic origin on therapeutic response.~   "
220440|NCT00673452|"~     The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once~     daily in comparison to placebo on symptom improvement in patients meeting criteria for~     fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo,~     however, all patients will receive duloxetine at some point in the study.~   "
220441|NCT00673439|"~     The purpose of this study is to determine how safe and effective fondaparinux is in treating~     patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).~   "
220442|NCT00673426|"~     The purpose of this study was to evaluate safety, not inferiority clinical and~     pharmacodynamic profile of the drug Enoxaparin Sodium produced by laboratory Blausiegel when~     compared with Clexane product, produced by Laboratory Sanofi-Aventis in 60 patients with~     Chronic Renal Desease.~   "
220443|NCT00673413|"~     The present work had as purpose to analyze estomy-individuals according to the feelings of~     their current situation.~   "
220444|NCT00673400|"~     The stapled transanal rectal resection (STARR procedure) is an effective treatment for~     obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new~     technique has been developed using the new Contour® TranstarTM stapler, which was~     specifically designed to facilitate the STARR procedure. The investigators would like to~     evaluate the morbidity and quality of life.~   "
220445|NCT00673387|"~     A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety,~     tolerability and effect on body weight of a range of doses of metreleptin and pramlintide,~     each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.~   "
220446|NCT00673374|"~     To determine the correlation between the region of abdominal tenderness determined by the~     examining physician and the location of acute pathology diagnosed on abdominal CT. We~     hypothesize that the acute pathology diagnosed by CT will lie within the region marked on the~     abdominal wall by the examining physician prior to CT.~   "
220522|NCT00672373|"~     The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in~     the treatment on Tardive dyskinesia~   "
220448|NCT00673348|"~     Voriconazole (VCZ), the antifungal drug active against Candida and Aspergillus is a substrate~     of CYP2C19, whose proportion of poor metabolizers is about ~20% in Asian population. The~     AUC's of VCZ differs over 4 folds by CYP2C19 genotypes of homozygotic wild type,~     heterozygote, and homozygotic poor metabolizers. The Asian population enrolled in the~     metabolism of VCZ were mainly Japanese and Chinese, without Korean subjects. The proportion~     of poor metabolizers in Korean population is known to be around 12% (Pharmacogenetics. 1996~     Dec;6(6):547-51). The importance of CYP2C19 genotypes on the pharmacokinetics (PK) of~     voriconazole is well established, Hence, it is desirable to individualize the dosage regimen~     of VCZ according to the genotypes of patients. Fungal infection in immunocompromised patients~     is a life threatening condition which needs critical care. Although the PK change by~     genotypes are well known, its clinical implication or need for different dosage regimen by~     genotypes is not established, yet.~   "
220449|NCT00673335|"~     RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2~     mutation.~      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works~     compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or~     BRCA2 mutation.~   "
220450|NCT00673322|"~     The purpose of this study is to collect data on the safety and effectiveness of 2nd~     generation designer T cells in patients with colorectal cancer. Designer T cells are prepared~     by collecting white blood cells from the participant, and then modifying these cells in the~     laboratory so that they recognize the tumor antigen (CEA). These modified cells are then~     given back into the participant so that they can attack and kill tumor cells.~   "
220451|NCT00673309|"~     The purpose of this study is to find ways to improve wound healing and decrease the negative~     effects of trauma from burn injury.~   "
220452|NCT00673296|"~     Diabetic premacular hemorrhage occurs when blood from preretinal neovascular tissue is~     entrapped between the retina and the posterior hyaloid in the macular area. It may occur~     spontaneously or secondary to traction from a localized posterior vitreous detachment. This~     complication may greatly disturb the central vision and may be an important stimulant of~     fibrovascular proliferation.~      Bevacizumab (Avastin, Genentech, Inc.) is a humanized monoclonal antibody against vascular~     endothelial growth factor (VEGF), which has been used to treat a variety of neovascular~     ocular diseases. In proliferative diabetic retinopathy, intravitreal bevacizumab has been~     shown to induce prompt regression of neovascularization and may enhance resolution of~     vitreous hemorrhage.~      In this study, we propose that simultaneous intravitreal injection of gas and bevacizumab may~     be a useful treatment option in diabetic premacular hemorrhage with active fibrovascular~     tissue. In this procedure, gas is used to displace the blood while bevacizumab may render the~     neovascularization less active to decrease the likelihood of recurrent hemorrhage.~   "
220453|NCT00673283|"~     This project proposes a new method, Bi-plane Correlation Imaging (BCI), for improved~     detection of subtle lung nodules. In BCI, two digital radiographs of the chest are acquired~     within a short time interval from slightly different posterior projections. The image data~     are incorporated into an enhanced Computer-aided Diagnosis (CAD) algorithm in which nodules~     present in the thoracic cavity are detected by examining the geometrical correlation of the~     detected signals in the two views. The data are alos viewed stereoscopically for visual~     diagnosis. The expected high sensitivity/specificity of the method has the potential to~     change the current state of practice, perhaps leading to a preventive lung cancer screening~     program for high-risk populations, similar to the mammography screening program currently in~     place for breast cancer.~   "
220454|NCT00673270|"~     Septic shock (associated with relative adrenal insufficiency) is characterized by decreased~     arterial responsiveness to catecholamines. The association of hydrocortisone and~     fludrocortisone has demonstrated an improvement in survival in septic shock patients. If~     hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone~     remains to be elucidated. The purpose of our study is to investigate the effect of a~     physiological dose of fludrocortisone and/or hydrocortisone on phenylephrine-mean arterial~     pressure dose-response relationship in healthy volunteers with aldosterone suppression~     induced by intravenous sodium loading.~   "
220455|NCT00673257|"~     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the~     laboratory may help doctors learn more about how patients respond to treatment with certain~     chemotherapy drugs.~      PURPOSE: This laboratory study is looking at the pharmacokinetics of daunorubicin in treating~     young patients with cancer.~   "
220456|NCT00673244|"~     The principal objective is to safely determine if we can identify the severity of Acute~     Kidney Injury (AKI) early in the course of the disease. Once enrolled, we will draw blood and~     urine for relevant biomarkers. Our goal is to validate if any of these biomarkers can predict~     the course of AKI (recovery v. RRT v. death)~   "
220457|NCT00673231|"~     This study is being carried out to see if Dapagliflozin in addition to insulin is effective~     and safe in treating patients with type 2 diabetes when compared to placebo (identical~     looking inactive treatment) in addition to insulin~   "
220458|NCT00673218|"~     If you are allergic to ragweed, and not taking certain medications, you will be asked to have~     blood drawn. We will perform experiments on your blood cells.~   "
220459|NCT00673205|"~     The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy,~     versus placebo, in subjects who have either undergone a primary therapy (principally radical~     prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.~   "
220532|NCT00672243|"~     Primary objective:~      To determine the 6-month progression free survival of patients with recurrent glioblastoma~     multiforme (GBM) treated with Erlotinib plus Sirolimus.~      Secondary objectives:~      To further define the safety and tolerability of Erlotinib plus Sirolimus when administered~     to patients with recurrent GBM; and to evaluate progression free survival, radiographic~     response and overall survival of patients with recurrent GBM treated with Erlotinib plus~     Sirolimus.~   "
220533|NCT00672230|"~     The clinical trial aspect of this study is the provision of a lutein supplement to lactating~     women and compare the amount of lutein in the milk and blood with lactating women who do not~     receive the lutein supplement.~   "
220804|NCT00668616|"~     The purpose of this study is to determine whether a treatment with 4 cycles anthracycline +~     cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than~     therapy with 4 cy<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel~   "
220460|NCT00673192|"~     Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of~     the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women~     worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been~     consistently implicated in causing cervical cancer especially those high-risk types (HPV~     16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are~     infected by HPV within their whole lives. However, only 1% of HPV-infected women have~     cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host~     immune responses within 1 and 2 years later. It shows that host immunity plays an important~     role in the progression, persistence, or regression of HPV infection.~      There are two main defense lines in the host immunity including innate immunity and adoptive~     immunity. Adoptive immunity plays more important roles in the defense of HPV infections than~     innate immunity. The adoptive immunity could be further divided into humoral immunity and~     cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate~     memory B cells to produce antibody which provide the protective function to HPV infection.~     Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific~     cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches~     focused on the immunity to HPV infection, there is no conclusion about the relationship~     between humoral and cell-mediated immunities on HPV infection and roles of humoral and~     cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer~     patients.~      Our research team has focused on the establishment of platforms on cell-mediated immunity to~     HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected~     population and cervical cancer patients for years. In order to survey the host immunity to~     HPV infection more comprehensively, we propose this proposal. First, we would like to set up~     the platforms to elucidate the humoral immunity to HPV infection in normal population and~     patients with CIN lesion or cervical cancer. Second, we would to survey the correlation~     betweem humoral immunity and status and clinico-pathologic items of HPV-infected populations.~     Our research results will have a more comprehensive overview in the host immunity to HPV~     infection and its related diseases. It could provide more information in the prevention and~     treatment of HPV infection in the future.~   "
220461|NCT00673179|"~     The goal of this clinical research study is to learn if giving certain combinations of~     chemotherapy drugs before and after surgery, mostly in the outpatient clinic instead of in~     the hospital, can result in fewer hospital stays during treatment for osteosarcoma. The drugs~     and schedules will vary depending on the status of the cancer and its level of risk for~     spreading, but they will include combinations of doxorubicin (non-liposomal), cisplatin,~     methotrexate, and ifosfamide, as described below.~   "
220462|NCT00673166|"~     We observed in a randomised intervention trial in Bissau that mortality due to malaria could~     be reduced by half by adding a small monetary incentive to the staff and strict follow-up of~     a standard protocol for available drugs. The Government and donors are not able to sustain~     such incentives. We intend to evaluate whether strict organisation of a cost recovery system~     and the use of part of the funds for staff incentives would improve performance of the staff~     and contribute to reduction of hospital and post-discharge mortality.~   "
220463|NCT00673153|"~     RATIONALE: Vorinostat may stop the growth of cancer cells by interfering with various~     proteins needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin (GO),~     can block cancer growth in different ways. GO finds cancer cells and helps kill them by~     carrying a cancer-killing substance to them. Giving vorinostat together with gemtuzumab~     ozogamicin may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving vorinostat together with gemtuzumab~     ozogamicin works in treating older patients with previously untreated acute myeloid leukemia.~   "
220464|NCT00673140|"~     Amyotrophic Lateral Sclerosis (ALS, sometimes called Lou Gehrig's s Disease, or Maladie de~     Charcot) is a progressive, usually fatal, neurodegenerative disease caused by the~     degeneration of motor neurons, the nerve cells in the central nervous system that control~     voluntary muscle movement.~      This study will investigate the use of far infrared radiation for the control, management and~     treatment of ALS.~   "
220465|NCT00673127|"~     The combination of ketaconazole and hydrocortisone is commonly used for the treatment of~     prostate cancer. The purpose of this study is to determine if the addition of a drug called~     dutasteride to this approved combination will make the combination more effective in treating~     prostate cancer.~   "
220466|NCT00673114|"~     Subjects will be diagnosed with a hematological malignancy (cancer of the blood), which is~     unlikely to be cured with conventional non-transplant therapy. The best results of bone~     marrow transplant are obtained with the donor is a relative that has identical tissue type~     (HLA-type). These subjects will not have such a donor available but they will have a~     appropriately matching unrelated umbilical cord blood unit (UCB). However, the cord blood~     unit does not contain a high enough number of cells and may take longer to engraft (or grow).~     The purpose of this study is to determine whether the addition of stem cells from a family~     member to supplement a standard unrelated cord blood transplant is safe and will increase the~     success of the cord blood transplantation procedure. Subjects enrolled in this study will~     receive an unrelated cord blood transplant plus a haplo-identical (half-matched), T-cell~     depleted stem transplant from a related donor. The goal of this study is to determine whether~     the addition of the related stem cells accelerates bone marrow recovery and improves~     long-term disease free survival.~   "
220467|NCT00673101|"~     The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers~     in patients treated with methotrexate.~   "
220468|NCT00673088|"~     The objective of this study was to assess the single dose bioequivalence of Roxane's~     Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting~     conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over~     design.~   "
220469|NCT00673075|"~     This study is being done to see if the blood pressure lowering effect of an approved drug~     nebivolol is comparable to that of another approved drug carvedilol for the treatment of~     hypertension in patients who have coronary artery disease.~   "
220470|NCT00673062|"~     This study is to evaluate the effectiveness of a new drug on congestion in subjects with~     seasonal allergic rhinitis. This effect will be compared to placebo and to the decongestant,~     pseudoephedrine.~   "
220471|NCT00673049|"~     The objective of this study is to test a clinical benefit of the addition of CP 751,871 to~     erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The~     primary endpoint is Overall Survival (OS).~   "
220472|NCT00673036|"~     The Fast-MI registry was designed to evaluate the real world management of patients with~     acute myocardial infarction (MI), and to assess their in-hospital, medium and long-term~     outcomes~   "
220473|NCT00673023|"~     The purpose of this study is to determine whether plasma lipoproteins and lipid~     responsiveness to a dietary modification is influenced by CETP gene polymorphism.~   "
220534|NCT00672217|"~     The primary goal of the proposed study is to examine a cognitive behavioral intervention for~     insomnia (CBTI) in women after breast cancer treatment. Chronic Insomnia is a highly~     prevalent and distressing symptom in cancer patients. CBTI is considered the treatment of~     choice for chronic primary insomnia. Few studies have been conducted in cancer survivors to~     evaluate the effect of CBTI on sleep and clinically relevant outcomes.~   "
220474|NCT00673010|"~     One of the most effective treatments for metastases from thyroid cancer is a form of~     radioactive iodine known as 131-I. For more than 50 years, 131-I has been used to find and~     destroy thyroid cancer cells that have spread to other parts of the body. In many cases this~     treatment destroys the metastatic cells. However, in some patients it does not appear to work~     completely. This study is designed to use a slightly different form of radioactive iodine~     (called 124-I) which can precisely predict the amount of radiation that each metastatic~     lesion will receive.~      124-I was developed at Memorial Sloan-Kettering in the 1950s and has been used here and at~     many other medical centers around the world for diagnostic studies. It has been found to be~     very safe and effective at finding metastatic lesions. The high resolution of newer PET~     scanners now allows us to carefully determine how much radiation each metastatic lesion will~     receive. If 124-I can accurately predict which patients will not respond to 131-I treatments~     we can then avoid exposing those patients to unnecessary radiation. For the rest of the~     patients we can custom tailor the 131-I dose to destroy the metastatic lesions.~   "
220475|NCT00672997|"~     The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness~     of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma~     or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997)~     and Japan (C-08-08, NCT00760539).~   "
220476|NCT00672984|"~     To assess the effect of immediate-release guanfacine hydrochloride, administered at~     therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females~   "
220477|NCT00672971|"~     The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control~     of head lice and to compare the efficacy to a permethrin based product.~   "
220478|NCT00672958|"~     The purpose of this study is to determine the efficacy and safety of once daily vortioxetine~     (Lu AA21004) in adults with major depressive disorder.~   "
220479|NCT00672945|"~     A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 in subjects with~     Alzheimer's Disease receiving a stable dose of donepezil. The study consists of a 26-week~     double-blind treatment period.~   "
220480|NCT00672932|"~     This pilot study focuses on the persistence of central nervous system (CNS) immune activation~     that has been observed in the presence of 'effective' combination antiretroviral therapy~     (cART). Attention to this issue is based on the fear that chronic CNS immunoactivation can~     cause indolent brain injury that will eventually compromise brain function as patients~     survive for years on treatment. A leading hypothesis explaining this continued~     immunoactivation is that viral replication continues within the brain at a level too low for~     detection in cerebrospinal fluid (CSF), yet sufficient to stimulate local immunoactivation.~     Based on this hypothesis, we propose to use augmented treatment with raltegravir to test~     whether additional suppression of this hypothesized CNS HIV-1 replication will reduce~     continued CNS immunoactivation.~   "
220481|NCT00672919|"~     The purpose of this study is to measure the triglyceride changes in subjects with type 2~     diabetes mellitus taking pioglitazone, once daily (QD), following treatment conversion from~     rosiglitazone.~   "
220482|NCT00672906|"~     While parents are considered essential for the effective treatment of adolescents with~     anorexia nervosa, the most effective manner to involve parents in treatment is unknown. Given~     reports of high caregiver burden among parents of this clinical group, finding treatments~     that minimize parent burden while improving the child's eating disorder symptoms is~     essential.~      This investigation will examine the preliminary effectiveness of a parent skills group and~     adolescent skills group compared to family therapy for the treatment of adolescent anorexia~     nervosa. The target of this intervention is the improvement of eating disorder symptoms in~     the child and improving self-efficacy, emotion regulation, and perceived burden in the~     parent.~      The effectiveness of this experimental treatment group (Group Parent Training for the~     parents/Adolescent Skills Training for the adolescent) will be compared to the Maudsley model~     of family therapy. The effectiveness of the group program will be examined by exploring~     changes within individuals over time as well as via comparisons across treatment conditions.~     Results from this investigation will be used to calculate treatment effect sizes in the~     design of a larger, fully powered, randomized clinical trial.~   "
220483|NCT00672893|"~     Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the~     lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds).~     Airflow in the lungs during the respiration cycle creates vibrations that propagate through~     the lung tissue; these vibrations are affected by the structural properties of the lungs and~     may vary in space, time and frequency. Moreover, any structural alteration, such as a~     bronchial obstruction or space occupying infiltration, is reflected in a corresponding~     modification of the vibration response.~      As obstructions that occur in airways alter airflow, the VRI may provide additional lung~     function information prior to treatment for airway obstruction and during follow-up.~     Moreover, the VRI may provide the physician immediate evaluation of the improvement of air~     flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a~     non-invasive, radiation free procedure which is simple and doesn't require the level of~     patient effort required for lung function test and other evaluation.~   "
220484|NCT00672880|"~     This study is for people with chronic low back pain who may also be feeling discouraged,~     frustrated, or depressed. This study is testing a new therapy that is designed to~     specifically help these patients foster a better self-image. We hope this therapy will help~     them feel less discouraged and depressed and, possibly, even help reduce their stress enough~     that they may feel less pain.~   "
220485|NCT00672867|"~     The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus~     Adefovir dipivoxil in patients with LC-B.~   "
220486|NCT00672854|"~     Many hospitalized patients who are malnourished or not eating receive intravenous feeding or~     total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of~     infections and hospital complications. We do not know why TPN increases hospital~     complications, but it may be caused by the high sugar or fat content in TPN solutions.~   "
220575|NCT00671645|"~     -  feasibility and tolerance of preoperative therapy with Bevacizumab in combination with~          Capecitabine and radiotherapy for patients with locally advanced, locally operable~          rectal carcinoma~        -  collection of response rate (T- and M-downstaging, pathological complete remission)~   "
220487|NCT00672841|"~     This is a single center, prospective, open label assessment of β-D-glucan surveillance with~     preemptive anidulafungin therapy versus standard care for the prevention of invasive~     candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be~     stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance~     using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will~     receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single~     determination. Subjects in the standard care arm will have biweekly blood draws for~     β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in~     the standard care arm is at the discretion of the treating physicians. The primary study~     end-points are the feasibility of a preemptive antifungal strategy in a SICU setting,~     β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin.~     Risks associated with study participation include the risks associated with blood draws,~     study drug related side effects, and the potential for loss of confidentiality.~   "
220488|NCT00672828|"~     RATIONALE: An interactive computer program may be more effective than a brochure in~     increasing colorectal cancer screening among African Americans.~      PURPOSE: This randomized clinical trial is studying an interactive computer program to see~     how well it works compared with a brochure in increasing colorectal cancer screening among~     African Americans.~   "
220489|NCT00672815|"~     The purpose of this study was twofold: 1) to assess awareness of and adherence to Texas SB42~     among a representative sample of public middle schools in Texas; and 2) to assess the impact~     of SB42 on the frequency of school PE class, the quality of school PE, and prevalence of~     child self-reported physical activity behaviors and child overweight along the Texas-Mexico~     border.~   "
220490|NCT00672802|"~     This purpose of this study is to assess the safety of ramelteon, once daily (QD), in subjects~     with chronic obstructive pulmonary disease.~   "
220491|NCT00672789|"~     Medication non-adherence is a true public health problem. Despite advancements in the~     molecular understanding of disease and improvements in therapy, patient health outcomes will~     not improve unless patients take prescribed medications regularly. Decreasing the gap between~     efficacious and effective therapy for patients with SCD is an essential research agenda.~     Hydroxyurea has been shown to be safe and efficacious in children and infants. However, the~     effectiveness of the prophylaxis depends on adherence to the recommended regimen. Medication~     adherence in SCD has previously been found to be sub-optimal in patients taking penicillin,~     desferoxamine, and pain medication. Adherence to HU has been studied to some extent in~     children with SCD. Based on estimates of adherence in other chronic illness we expect~     approximately 50% of patients to be >80% adherent with their HU administration. There is no~     gold standard for improving adherence to treatment. There have been a few attempts in the SCD~     population to improve adherence. These include a day camp to promote education about~     desferoxamine and peer support, a combination of a slide-show about SCD and it complications,~     weekly phone calls by the clinic social worker and a calendar, and a seven-phase educational~     program. Given the striking improvements in the peripheral blood smear findings of patients~     with SCD on HU therapy, with reduction in the numbers of sickled cells, we hypothesize that~     viewing the peripheral blood smear of patients with poor adherence to HU compared to a blood~     smear of someone on HU can be used to improve adherence in non-adherent patients.~      We will conduct a randomized trial between the intervention of regularly showing children and~     their parents the peripheral blood smear and standard care, including reminders of the~     importance of compliance and review of complete blood count parameters, including WBC, MCV,~     and Hgb concentration. The outcome measures will be increase in hemoglobin concentration and~     %HbF and increase in perceived QOL. QOL will be measured with age-appropriate and~     parent/proxy PedsQL™. Medication adherence will also be monitored throughout the study with~     pharmacy prescription refills, physician assessment, and self-report via a visual analogue~     scale. Adherence estimates, hemoglobin concentration, %HbF and QOL will be measured at~     baseline, 3 months and 6 months.~   "
220492|NCT00672776|"~     Posttraumatic stress disorder (PTSD) is a major public health problem in this country. It is~     estimated that at least one out of every seven women in our society have been the victim of~     childhood sexual abuse at least once before their 18th birthday. Previous studies have shown~     that stress is associated with damage to neurons of the hippocampus, a brain area involved in~     learning and memory. Also, imaging studies of brain function are consistent with dysfunction~     of the medial prefrontal cortex during presentation of traumatic cues. We have previously~     shown that serotonin reuptake inhibitor medications (paroxetine; Paxil) can change memory~     function and hippocampal structure in PTSD. We now propose to perform a placebo controlled~     study with Paxil CR (paroxetine hydrochloride controlled-release tablets), which is thought~     as paroxetine with less side-effects. The main purpose of this study is to determine the~     effects of Paxil CR on memory deficits measured with neuropsychological testing, hippocampal~     volume measured with a magnetic resonance imaging (MRI), medial prefrontal lobe cortical~     function estimated with PET, and cortisol response (reflecting the intensity of stress) in~     men and women with PTSD. We plan to recruit 40 subjects. After completing physical~     examination and evaluating neuropsychiatric history, patients will undergo an initial group~     of tests which includes memory testing, MRI and PET brain scan, and measurement of cortisol~     in their saliva. Afterwards, half will receive Paxil CR 12.5 to 62.5 mg and half will receive~     a placebo (sugar pill) in the beginning of the first 12 weeks as Double Blind Phase. After~     12 weeks, they will be administered memory tests, PET and MRI scan for the post-treatment~     phase. After this period, Paxil CR will be offered to the placebo group and followed for an~     additional 12 weeks. They will have final memory tests, and a MRI scan. We hypothesize that~     Paxil CR exerts its efficacy by acting on abnormal neural circuits, including hippocampus and~     prefrontal cortex, in PTSD.~   "
220493|NCT00672763|"~     The purpose of this study is to determine whether the addition of vitamin D to standard~     corticosteroids improves onset of remission in active Crohn's Disease, a form of Inflammatory~     Bowel Disease (IBD).~   "
220494|NCT00672750|"~     This will be a retrospective review of approximately 900 patients who have undergone~     laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. All~     patients who have had laparoscopic myomectomy will be included. Only those not wishing to~     take part in the survey will be excluded. The data will then be compiled for statistical~     analysis , looking at pain, bleeding and subsequent fertility.~   "
220495|NCT00672737|"~     We would like to test the effect of opioid medication on pain sensitivity in subjects who~     have been diagnosed with a sleep disorder called Obstructive Sleep Apnea (OSA) compared to~     other subjects without OSA. Patients with OSA may have an altered sensitivity to the~     sedative, analgesic, and respiratory depressant effects of opioids.~   "
220496|NCT00672724|"~     The purpose of this study is to evaluate subjectively reported treatment effects of~     ramelteon, once daily (QD), in adults with chronic insomnia.~   "
220497|NCT00672711|"~     The association between the COMT haplotypes and the presence or absence of CPSP or CRPS will~     be assessed stratifying the patients based on the individual categories of trauma or elective~     surgery.~   "
220498|NCT00672698|"~     The purpose of this study is to establish the surgical risk factors and differences between~     different diseases in elderly patients submitted to elective surgery in our institution.~   "
220537|NCT00672178|"~     The purpose of this study is to determine the safety and efficacy of combined stereotactic~     body radiotherapy (SBRT) + sorafenib in the treatment of patients with Stage IV renal cell~     carcinoma (RCC) who have recurred locally, developed progression of an unresectable primary~     or progression of extra-cranial and/or extra-pulmonary metastases while on sorafenib. All~     subjects will remain on sorafenib during SBRT.~   "
220499|NCT00672685|"~     Epidemiological and fundamental research carried out in recent years has highlighted the role~     played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing~     age and Alzheimer's disease. In addition, it has been recognized for some years, following~     several convergent studies on the prevention of cognitive decline, that nutrition, physical~     exercise, cognitive training and social activities play a significant role in the maintenance~     of cognitive faculties. At present, there are a number of epidemiological arguments in favour~     of a protective role of each of these factors taken in isolation. It can be postulated that a~     multi-domain intervention may potentiate the protective role of omega-3 fatty acids.~      The main objective of this study is to assess the efficacy of isolated supplementation with~     omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise,~     cognitive stimulation, social activities), or their combination on the change of cognitive~     functions in frail elderly subjects aged of 70 years and older over 3 years.~      Secondary objectives:~        -  To assess the efficacy of each treatment strategy on the change of functional capacities~          and the prevention of dependency,~        -  To study the long-term safety and tolerability of V0137,~        -  To study compliance and adhesion to the multi-domain intervention programme,~      Ancillary studies :~      To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : :~     impact of multidomain intervention on brain metabolism (FDG-PET))~        -  To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain~          intervention ) of MAPT study on brain atrophy (MRI),~        -  To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans~          (MAPT AV45),~        -  To determine if sleep disorders at early stage of Alzheimer 's disease could be~          predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)~        -  To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA~          scans (MAPT-DXA)~   "
220500|NCT00672672|"~     The purpose of this study is to determine if the use of autologous platelet gel (APG) on~     sternal incision and conduit sites will improve wound healing and decrease the incidence of~     infection in patients undergoing coronary artery bypass grafting surgery~   "
220501|NCT00672659|"~     The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily~     (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of~     citalopram 40 mg in these patients.~      Secondary objectives are to demonstrate whether the addition of pipamperone 5 mg twice daily~     (bd) to citalopram, 40 mg daily in patients suffering from MDD:~        1. Will increase the rate of resolution of symptoms with citalopram 40 mg.~        2. Show the combined product to be safe and tolerable.~      Patients are scheduled to receive study medication for eight weeks and a final follow-up~     check will be carried out 28 days after completing the study.~      All patients will receive active citalopram from baseline and will be randomised to receive~     either active pipamperone or a placebo equivalent for eight weeks during which time they will~     attend for 6 study visits.~   "
220502|NCT00672646|"~     The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by~     the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of~     AZD1386 to placebo (inactive substance) on pain. A number of patients will instead receive~     the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen,~     will be allowed if a need for additional painkillers would arise. A number of patients will~     receive naproxen as control.~   "
220503|NCT00672633|"~     The investigators will conduct a randomized clinical trial to evaluate the efficacy of Lovaza~     (formerly known as Omacor) in reducing triglyceride levels in youth ages 10-19 years old~     whose baseline triglycerides range from 150 mg/dl to 1000 mg/dl. Seventy subjects will be~     recruited at baseline and randomized to the treatment condition, Lovaza 4 grams/day for 6~     months or the control condition, a corn oil placebo, 4 tablets a day for 6 months.~     Participants in both the treatment and control groups will receive the standard of care,~     which is dietary advice to follow a low, refined carbohydrate and low saturated fat diet that~     emphasizes increasing intake of fruits and vegetables and eating 2 servings per week of~     fishes rich in omega-3 fatty acids, consistent with the American Heart Association~     recommendations. The primary outcome will be change in fasting triglycerides from baseline to~     3 months. The investigators hypothesize that patients who receive LOVAZA will have~     significantly greater reductions in plasma triglyceride levels when compared to patients on~     placebo at 3 months.~   "
220504|NCT00672620|"~     The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily~     (QD), in adults with major depressive disorder.~   "
220505|NCT00672607|"~     To compare the efficacy and safety of Agnucaston tablets with placebo for the treatment of~     Premenstrual Syndrome (PMS) and assess if Agnucaston tablets are superior to placebo on~     efficacy or not.~   "
220506|NCT00672594|"~     The purpose of this study is to look at blood and tissue samples for changes following the~     use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib~     malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as~     Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors~     of intestines and kidney but it is being tested in research studies for use in men with~     prostate cancer.~   "
220507|NCT00672581|"~     This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down~     and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to~     healthy subjects of a similar age, sex and weight. As for all clinical trials, safety and~     tolerability of the drug will be evaluated as well to develop dosing recommendations for~     dosing of ZD4054 (Zibotentan) in subjects with varying stages of hepatic impairment.~   "
220508|NCT00672568|"~     The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of~     a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for~     rotator cuff repair of the shoulder~   "
220509|NCT00672555|"~     The investigators think, that the treatment of pilonidal sinus with excision and covering of~     the defect with a Limberg-flap is a very good treatment option. The investigators are~     introducing this treatment for recurrences of this illness in our clinic and want to analyse~     the feasibility, the results, the complications and the patients opinion after the treatment.~      If the results are good, a prospective randomised study is a further option.~   "
220535|NCT00672204|"~     The primary objective of this protocol is to test the safety and efficacy of a treatment~     regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed~     by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the~     destruction and rejection of islet transplants in type 1 diabetic recipients.~      Genentech, the manufacturer of efalizumab voluntarily withdrew the drug from the U.S. market~     in April of 2009. Previously transplanted subjects have been transitioned to alternative~     immunosuppressives and no new subjects will be transplanted under this protocol.~   "
220536|NCT00672191|"~     The purpose of this study is to examine the ability of AGS-004 to control HIV-1 replication~     and to determine if HIV-1 immunotherapy made with dendritic cells is safe and well tolerated,~     to determine if immunotherapy increases the body's immune response to HIV-1; and, to~     determine if after stopping anti-HIV drugs, immunotherapy can control the HIV-1 virus.~   "
220510|NCT00672542|"~     Transfection with siRNA targeting the immunoproteasome alters proteasome-mediated antigen~     processing by the dendritic cell, generating TAA-derived peptides that we hypothesize, based~     on preclinical results, will induce enhanced anti-melanoma immune responses. This phase I~     study, open to subjects with metastatic melanoma, will assess the safety of vaccination with~     melanoma tumor associated antigen-encoding RNA-transfected mature dendritic cells derived~     from monocytes that have been either untreated, transfected with control siRNA, or~     transfected with siRNA targeting the inducible immunoproteasome beta subunits LMP2, LMP7, and~     MECL1. A combination of RNAs encoding melanoma tumor associated antigens MART-1, tyrosinase,~     gp100, and MAGE-3 will be utilized for dendritic cell transfection. The vaccine will be~     administered by intradermal injection in the extremities. Clinical and laboratory toxicities~     will be characterized for each study arm. As a secondary objective, this phase I study will~     also assess the anti-melanoma immune responses, as well as clinical responses, induced by~     vaccination with this dendritic cell-based product.~   "
220511|NCT00672529|"~     The purpose of this study is~        1. To pilot the research methodology for a randomized trial on an orthomolecular treatment~          regime versus placebo as add-on therapy for children with asthma;~        2. To obtain a preliminary estimate of the effectiveness of an orthomolecular treatment~          regime for allowing tapering of inhaled corticosteroids in clinically stable asthmatic~          children. The obtained estimate will allow sample size calculations for a full-scale~          randomized trial; and~        3. To obtain preliminary information about the safety and tolerability of an orthomolecular~          treatment regime.~   "
220512|NCT00672516|"~     We believe ongoing bleeding during complex cardiac surgery can be accurately measured and~     that administration of a specific blood product replacement strategy designed to optimally~     slow or stop the bleeding can be followed by the during the operation.~      Patients at risk of significant bleeding after complex cardiac surgery will be approached to~     allow their operation to be watched by study personnel to see if ongoing blood loss can be~     accurately measured and to see how quickly a prescribed, standardized blood product~     replacement protocol to control the bleeding does slow or stop the bleeding. Permission to~     review the medical record to see if bleeding risk features can be identified and permission~     to follow the patient after surgery to see how they recover is also requested.~   "
220513|NCT00672503|"~     The purpose of this study is to identify risk factors associated with indwelling urinary~     catheters, as well as to assess the nurses' knowledge and adherence to hospital policies. The~     study will also include a very extensive literature search in an attempt to create a national~     standard or guideline.~   "
220514|NCT00672490|"~     To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct~     therapy to lithium in the treatment of patients with acute mania in bipolar disorder.~     Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria~     (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single~     Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation~   "
220515|NCT00672477|"~     This study will evaluate the safety and efficacy of methylnaltrexone administered as~     subcutaneous injections in subjects who have opioid-induced constipation and an advanced~     illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving~     opioid-induced constipation in these subjects.~   "
220516|NCT00672464|"~     Primary Objective: To compare added metformin and/or added simvastatin versus no intervention~     in reducing or eliminating increased cardiovascular risk (as estimated by elevation in~     non-HDL cholesterol levels) during the treatment of schizophrenia with olanzapine.~      Secondary Objective(s): To compare added metformin and/or added simvastatin versus no~     intervention in reducing or eliminating increased cardiovascular risk (as estimated by~     elevation in triglyceride levels) during the treatment of schizophrenia with olanzapine. To~     compare added metformin and/or added simvastatin versus no intervention in reducing or~     eliminating increased cardiovascular risk (as estimated by C-reactive protein levels) during~     the treatment of schizophrenia with olanzapine~   "
220517|NCT00672451|"~     Rhubarb extract is a chinese herbal preparation that is used in china and other asian~     countries to treat constipation and chronic kidney disease. Use of angiotensin converting~     enzyme inhibitors (ACEI) in diabetic kidney disease has been shown to be beneficial in~     slowing progression. The purpose of this study is to determine the combined effect of rhubarb~     plus enalapril (an ACEI)in slowing the rate of decline of CKD in people with kidney disease~     from diabetes.~   "
220518|NCT00672438|"~     Proposed twin study will test to what degree inter-individual differences in pain sensitivity~     and amount of pain relief in response to opioid therapy are inherited or alternatively, are~     due to environmental factors. This knowledge is important to guide future studies trying to~     explain such inter-individual differences. For example, finding that differences are largely~     due to environmental factors would discourage genomic studies and emphasize epidemiological~     studies.~   "
220519|NCT00672412|"~     In 2005, there were 50,620 HIV-infected children living in Thailand. Current anti-HIV~     regimens, comprised of individual pills for each drug, frequently lead to missed doses. To~     properly control their infection, regimens that are tolerable and effective in children and~     without pill burden are necessary. The primary purpose of this study is to evaluate the~     safety and bioavailability of GPO-VIR Z30, a combination fixed dose tablet containing~     zidovudine (ZDV), lamivudine (3TC), and nevirapine (NVP), in HIV-infected children in~     Thailand.~   "
220520|NCT00672399|"~     This Phase 1, randomized, three period, placebo- and positive-controlled,double-blind,~     double-dummy, crossover study will be performed with approximately 80 healthy male and female~     subjects. The effects of single doses of exenatide (10 μg, subcutaneous), moxifloxacin (400~     mg, oral) or placebo(subcutaneous or oral) on QT interval will be assessed.~   "
220521|NCT00672386|"~     The purpose of this study is to investigate the effectiveness and safety of 12 weeks of~     treatment with R256918 in patients with Type 2 Diabetes Mellitus who are taking metformin.~     The primary measure of effectiveness is the change in concentration of glycated hemoglobin~     (HbA1c) during treatment. Glycated hemoglobin is a substance in red blood cells that is~     formed when blood sugar (glucose) attaches to hemoglobin and is a measure of diabetic status.~     Additional measures include fasting glucose, and lipid levels, and body weight. Safety~     assessments performed during the trial include laboratory tests, vital sign measurements, and~     adverse event reporting.~   "
220523|NCT00672360|"~     New evidence suggests that autistic disorder (AD) may be associated with abnormalities in~     folate metabolism, which is a process that affects genetic expression by facilitating the~     formation of methyl donors for DNA methylation. Limited data show that some children with AD~     show behavioral improvements with folic acid (FA) therapy, while others show a worsening~     effect. If behavioral worsening is linked with abnormalities in folate metabolism, then~     nutritional modifications could normalize these processes and result in clinical~     improvements. To address this premise, we propose a randomized, placebo-controlled crossover~     pilot study with two phases. The first phase will focus on the behavioral and biochemical~     responses of children with AD to high-dose folic acid supplementation. Because FA is an~     inactive folate that requires biochemical conversion to become active, and select genotypes~     impede this conversion, our general hypothesis is that FA will yield behavioral improvements~     in some children but exacerbate problem behaviors in others. During the second phase,~     children who had a worsened behavioral response to FA during phase 1 will participate in an~     open-label trial of high-dose Metafolin® supplementation. The focus here would similarly be~     on the behavioral and biochemical outcomes of participating children following treatment with~     the study supplement. Because Metafolin® is an active folate metabolite that should not be~     affected by genotypes in the folate pathway, our general hypothesis for phase 2 is that~     Metafolin® would yield behavioral improvements without the risk for behavioral worsening.~     Results from this project may provide support for continued study of the potential~     relationship between folate metabolism and problem behaviors among children with AD,~     potentially justifying the need to examine effects of folate supplementation among a larger~     sample of affected children.~   "
220524|NCT00672347|"~     Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better~     postoperative analgesia than either drug alone after urogenital pediatric surgery.~   "
220525|NCT00672334|"~     With over one million operations a year, cardiac surgery with cardiopulmonary bypass is one~     of the most common major surgical procedures worldwide (1). Acute kidney injury is a common~     and serious postoperative complication of cardiopulmonary bypass and may affect 25% to 50% of~     patients (2-4). Acute kidney injury carries significant costs (4) and is independently~     associated with increased morbidity and mortality (2,3). Even minimal increments in plasma~     creatinine are associated with an increase in mortality (5,6).~      Multiple causes of cardiopulmonary bypass-associated acute kidney injury have been proposed,~     including ischemia-reperfusion, generation of reactive oxygen species, hemolysis and~     activation of inflammatory pathways (7-10). COMT LL genotype appears to increase the risk of~     vasodilatory shock and AKI after cardiac surgery. To date, no simple, safe and effective~     intervention to prevent cardiopulmonary bypass-associated acute kidney injury in a broad~     patient population has been found (11-14).~      Urinary acidity may enhance the generation and toxicity of reactive oxygen species induced by~     cardiopulmonary bypass (10,15). Activation of complement during cardiac surgery (16) may also~     participate in kidney injury. Urinary alkalinization may protect from kidney injury induced~     by oxidant substances, iron-mediated free radical pathways, complement activation and tubular~     hemoglobin cast formation (9,17,18). Of note, increasing urinary pH - in combination with~     N-acetylcysteine (19,20) or without (21) - has recently been reported to attenuate acute~     kidney injury in patients undergoing contrast-media infusion.~      In a pilot double-blind, randomized controlled trial the investigators found sodium~     bicarbonate to be efficacious, safe, inexpensive and easy to administer. These findings now~     need to be confirmed or refuted by further clinical investigations in other geographic and~     institutional settings.~      Accordingly, the investigators hypothesized that urinary alkalinization might protect kidney~     function in patients at increased risk of acute kidney injury undergoing cardiopulmonary~     bypass needs to be confirmed in an international multicenter, double-blind, randomized~     controlled trial of intravenous sodium bicarbonate.~   "
220526|NCT00672321|"~     RATIONALE: Gathering information about vitamin D supplementation and sun exposure in patients~     with melanoma may help doctors learn more about the disease and find what may affect cancer~     relapse.~      PURPOSE: This clinical trial is studying vitamin D supplementation and sun exposure in~     patients who have undergone surgery for stage IB, stage II, or stage IIIA melanoma.~   "
220527|NCT00672308|"~     In cholera, the function of small intestine is affected resulting in increased secretion of~     electrolytes and water and their reduced absorption leading to profuse watery diarrhoea. The~     human colon has the capacity to absorb water and electrolytes. A number of recent studies~     have shown that short chain fatty acids (SCFAs) such as acetate, butyrate and propionate~     stimulates absorption of sodium in the colon, which is not affected by cyclic AMP. It has~     also been shown that SCFAs inhibits c-AMP mediated chloride secretion in the colon. Benefiber~     (partially hydrolyzed guar gum) is water soluble fibre, and when added to ORS it undergoes~     fermentation in the colon liberating SCFAs. SCFAs not only serves as metabolic fuel to the~     enterocytes but they also enhance colonic absorption of salts and water. Thus, they have~     potentials to reduce the severity of diarrhoea in patients with cholera. The aim of this~     study is to assess the efficacy of Benefiber-added WHO-ORS in the management of adults with~     cholera. In this randomized, controlled clinical trial, a total of 174 adult males with~     cholera would be studied. Study patients would be selected from those who attend the Dhaka~     Hospital of ICDDR,B with a history of diarrhoea of less than 24 hours and signs of severe~     dehydration. They would be rehydrated using intravenous fluid (cholera saline) over 4 hrs~     during which a stool specimen would be subjected for dark-field microscopy for identification~     of V. cholerae. Those identified to have cholera would be randomized in equal numbers to~     receive either: a) Benefiber (25 g/L) added WHO-ORS, b) Benefiber (50 g/L) added to the new~     formulation (Na+ 75, glucose 75, Cl- 65, K+ 20 mmol/L, citrate 10 mmol/L, osmolarity 245~     mosmol/L) of WHO-ORS , or c) the same WHO-ORS but without Benefiber for maintenance of~     hydration until resolution of diarrhoea. All patients would be treated with a single, 300 mg~     dose of doxycycline capsules and would be provided with the standard hospital diets. Fluid~     intake (intravenous fluid, ORS, and plain water) and output (stool, urine, and vomit) will be~     measured for each 6-hourly periods of the study. Patients would be hospitalized until~     resolution of their diarrhoea. Stool output, intake of intravenous fluid and ORS, the~     duration of diarrhoea, and the proportion of patients requiring unscheduled intravenous~     fluid therapy would be compared between the treatment groups. If Benefiber is found~     effective, it would be possible to formulate improved ORS for better case management of~     cholera.~   "
220528|NCT00672295|"~     Primary objective to determine the maximal tolerated (MTD) of dasatinib in combination with~     paclitaxel and carboplatin during the first cycle of treatment.~      Secondary objectives to describe the toxicity of this combination of therapy; to describe the~     pharmacokinetics and pharmacodynamics parameters related to this combination; to describe the~     clinical activity as defined as the response rate (complete and partial response rate) and~     progression-free survival > 6 month; to compare the SRC pathway microarray signature in pre~     and post-treatment cancer specimens; to evaluate SRC pathway downstream substrates, FAX,~     paxcillin, and CRK-L in pre and post-treatment cancer specimens.~   "
220529|NCT00672282|"~     The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy,~     versus placebo, in subjects who have either undergone a primary therapy (principally radical~     prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.~   "
220530|NCT00672269|"~     There is a high incidence among the first degree relatives of the carcinoid patients,~     indicating the involvement of genetic components in its initiation and pathogenesis.~   "
220531|NCT00672256|"~     The broad objective of this proposal is to identify functional neuroanatomical correlates of~     impairments in response inhibition during smoking abstinence. We will measure changes in~     performance and regional blood oxygenation levels using functional magnetic resonance imaging~     (fMRI)while smokers complete tasks designed to assess decision making and response~     inhibition.~      Our primary hypothesis is that smoking abstinence will result in impaired response inhibition~     accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in brain~     regions associated with these cognitive processes including frontal cortex and the ventral~     striatum. Abstinence may also result in performance-related increases in activation in brain~     regions associated with effortful processing including the anterior cingulate cortex in~     effort to compensate for deficits in other regions.~   "
220550|NCT00671996|"~     The present feasibility study is designed to find out whether pre-treatment with the compound~     mangafodipir lowers the frequency and severity of side effects during adjuvant chemotherapy~     according to the FOLFOX6 regimen in patients operated upon colon cancer in stage Dukes' C.~   "
220538|NCT00672165|"~     The purpose of this study is to find a safe dose of actinium-225 when it is labeled to~     HuM195. This will be done with a phase I trial, in which a preset schedule of doses gets~     more powerful for each new group of patients as the trial progresses. If too many serious~     side effects are seen with a certain dose, no one will be treated with a higher dose, and~     some additional patients may be treated with a lower dose to make sure that this dose is~     safe. The starting dose of actinium-225 in this study is less than doses that are known to be~     safe in animals.~      Antibodies are proteins that are produced by the immune system and help the body to fight~     foreign substances, such as bacteria or viruses. HuM195 was made by putting human leukemia~     cells into mice. Most of the mouse parts of this antibody were replaced with human parts.~     Only the part of the antibody that binds to the leukemia cells was kept from the mouse.~     HuM195 attaches to leukemia cells but does not attach to most normal cells. It can kill small~     amounts of disease by identifying the leukemia cells as foreign. HuM195 has worked less~     well against large amounts of leukemia since the normal immune cells needed to kill leukemia~     cells are lowered in most patients with leukemia.~   "
220539|NCT00672152|"~     The purpose of this study is to determine the safety and effectiveness of administering Wilms~     tumor gene 1 (WT1) cancer peptides. Cancer peptides are short pieces of protein that are made~     in a laboratory to be like the peptides that can be found in cancer. These peptides are~     intended to be given as a vaccine to activate the immune cells in a person to attack~     his/her cancer. These peptides are mixed with an oily substance called Montanide ISA-51 and a~     white cell growth factor called Granulocyte-macrophage colony-stimulating factor (GM-CSF)~     which may help make the immune response stronger.~   "
220540|NCT00672139|"~     This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the~     safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will~     be tested in late stage, advanced illness patients who have constipation caused by opioid~     pain relievers. This study will last 3 months.~   "
220541|NCT00672113|"~     This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in~     blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either~     Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then~     switched back to the original drug for one day. Blood samples, blood pressure, and heart rate~     are taken before and after each treatment period.~   "
220542|NCT00672100|"~     Objective: To determine a minimally effective initial local anesthetic bolus required to~     provide satisfactory analgesia using continuous brachial plexus infusion following~     arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial~     doses.~   "
220543|NCT00672087|"~     The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men,~     chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has~     hampered development of mechanistic treatment strategies for these common, chronic and~     distressing medical conditions. We believe that IC and perhaps CP/CPPS are a spectrum of~     complex but inter-related genetic and acquired diseases resulting from the interaction of~     several genes regulating immune/inflammatory and neurogenic parameters and environmental~     factors/circumstances or exposure, culminating in the combination of pain, frequency, urgency~     and sexual specific symptoms. New research has delineated the dynamic and powerful~     association of the immune and neurogenic system in pain activation. An immune-modulated~     neurogenic model of IC illuminating the action of immune derived substances and pain related~     substances might be important in discovering the determinants of pain, voiding dysfunction~     and gender specific sexual problems. This inter-related dynamic model of IC disease~     pathogenesis could be explored for potential avenues leading to novel diagnostic and~     treatment strategies. We plan to identify and evaluate the sensitivity and specificity of~     several novel nerve and inflammation related markers in the diagnosis and follow up of IC~     (and CP/CPPS). By correlating the levels of urine immune and pain related substances to~     disease mechanisms, severity and progression, we may be able to create a human disease~     specific model for diagnosis and treatment.~   "
220544|NCT00672074|"~     The purpose of this study is to determine if ipamorelin is safe and effective in the~     management of post-operative ileus.~   "
220545|NCT00672061|"~     The purpose of this study is to assess the safety of ramelteon, once daily (QD), in~     individuals with obstructive sleep apnea.~   "
220546|NCT00672048|"~     The purpose of this study is to develop new ways of assisting patients with glaucoma and~     their eye doctors in using the recommendations from practice guidelines.~   "
220547|NCT00672035|"~     The main purpose of this study is to evaluate the body's immune response to the LT patch at~     different doses.~      The secondary purpose of this study is to evaluate the safety of the LT patches at different~     doses and the safety of the skin preparation system. Another secondary purpose is to compare~     the safety and the body's immune response to LT patches placed on the upper arm versus the~     lower back.~   "
220548|NCT00672022|"~     We want to see if Zavesca (or miglustat) is safe and can be tolerated by patients with acute~     infantile onset GM2 gangliosidosis - classical Tay-Sachs and infantile onset Sandhoff~     disease. We know that miglustat inhibits the formation of GM2 ganglioside, the compound that~     is stored in the brains of children with Tay-Sachs and Sandhoff disease. Since it inhibits~     the synthesis of ganglioside, miglustat may be able to reduce or delay the onset of clinical~     symptoms.~   "
220549|NCT00672009|"~     The purpose of this research study is to determine the safety and effectiveness of the~     investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive~     surgery.~      Prostate cancer is a common and important health issue facing men in the United States. Most~     patients with prostate cancer are identified when the disease is limited to the prostate~     gland itself (localized prostate cancer). A standard treatment for some patients with~     localized prostate cancer is removal of the prostate gland in an operation known as a~     radical prostatectomy. A sub-set of patients with localized prostate cancer can be~     identified who are at high-risk of suffering a recurrence of prostate cancer after radical~     prostatectomy. For these patients, additional treatments are being investigated to combine~     with surgery in the hopes of increasing the chances for cure.~      Several kinds of chemotherapy medicines have been used for advanced prostate cancer which~     returns after initial therapy. Epothilones are a newly developed class of chemotherapy drugs~     that appear promising for the treatment of many forms of cancer. Ixabepilone is drug in the~     epothilone class of chemotherapy medicines that has shown encouraging results for the~     treatment of advanced prostate cancer and other cancers in clinical trials.~      This trial will include men with high-risk localized prostate cancer who will receive~     treatment with ixabepilone (4 cycles over 12 weeks) prior to radical prostatectomy. The goal~     of this trial will be to determine if analysis of genes and proteins in prostate cancer~     tissue taken before and after treatment can be used to predict ixabepilone response. In~     addition, this trial will evaluate the safety and feasibility of administering ixabepilone~     prior to radical prostatectomy for patients at high-risk of developing recurrent prostate~     cancer.~      The study has three phases: Screening, Treatment and Follow-up~        -  Screening: Eligibility will be verified~        -  Treatment: Subjects will receive Ixabepilone, which will be administered every 21 days~          for 4 cycles prior to surgery~        -  Follow up: Subjects will be followed every 6 months for up to 5 years.~      In addition, tissue will be collected at the time of surgery for genetic and protein studies.~     Blood will also be collected pre and post therapy for proteomic and/or genetic studies.~   "
220551|NCT00671983|"~     Obstructive sleep apnea (OSA) is a syndrome characterized by repetitive episodes of airway~     obstruction during sleep, which result in low oxygen level in the blood and bad sleep~     quality. Both of these effects are implicated in medical, neurological and cognitive~     disorders in subjects with OSA. The purpose of this study is to examine how OSA affects~     medical and neurobehavioral outcomes after gastric bypass surgery for weight loss in morbidly~     obese patients.~   "
220552|NCT00671970|"~     Primary objective:~      To estimate 6-month progression free survival probability of pts w recurrent malignant~     gliomas treated w erlotinib + bevacizumab.~      Secondary Objectives:~      To evaluate safety & tolerability of erlotinib + bevacizumab among pts w recurrent malignant~     gliomas To evaluate radiographic response of pts w recurrent malignant gliomas treated w~     erlotinib + bevacizumab To evaluate pharmacokinetics of erlotinib when administered to pts w~     recurrent malignant gliomas; & to examine relationship of clinical response to Epidermal~     Growth Factor (EGFR) expression, amplification, & v-III mutation, phosphatase and tensin~     homolog (PTEN) expression, vascular endothelial growth factor (VEGF) expression, vascular~     endothelial growth factor receptor 2 (VEGFR-2) & phosphorylated protein kinase B (PKB/Akt) in~     archival tumor samples~   "
220553|NCT00671957|"~     The aim of this study is to assess whether the energy you burn daily increases after you have~     bariatric surgery. Until now, there hasn't been an effective way of measuring all activity on~     a daily basis. Physical Activity Monitoring System (PAMS) has been created just for this~     purpose. PAMS is a garment that can be worn under your clothes, that records body position~     and movement through space. We will use the PAMS along with special water to measure your~     total daily energy expenditure right before surgery, and again 6 months and 24 months after~     surgery.~      Study subjects will be initially recruited from OHSU IRB-Approved advertisements. Interested~     study subjects will be screened through an informal telephone interview. If there are no~     health conditions that exclude participation, subjects will be asked to give IRB-approved~     consent.~      Subjects will be consenting to undergo three 18 day phases. Each phase will consist of 15~     daily visits to the Clinical & Translational Research Center (CTRC), and 3 full day and~     nights in the CTRC.~   "
220554|NCT00671944|"~     Osteoporosis is a major health problem in men and women in this country and the incidence of~     this disease is rising. We think that environmental factors such as nutrition may play a role~     in the increasing prevalence of osteoporosis. In particular, we think that a diet that is too~     low in protein may be contributing to bone loss. The primary purpose of this study is to~     compare the long-term impact of a low protein diet on measures of bone and calcium~     metabolism.~   "
220555|NCT00671931|"~     Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the~     anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the~     development of neurological deficits remains the most feared complication of spine surgery.~     During scoliosis surgery it is very important to monitor the spinal cord to detect spinal~     cord injury with surgical manipulation. Continuous or intermittent intraoperative~     electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures~     to provide the surgeon with information concerning the integrity of neurological structures~     at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the~     various intravenous anesthetic drugs, the combination of propofol, remifentanil and~     dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice~     is to use the three drugs in combination at doses that do not depress the signals but there~     is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring~     signals. The lack of data results in wide variability in dosing with consequent variability~     in patient response.~      Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of~     transcranial motor-evoked potentials (TcMEP) either independently or by interaction with~     propofol in a dose dependent manner.~   "
220556|NCT00671918|"~     Data from this pivotal clinical trial will be used to support a marketing application (i.e.,~     NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes)~     in the lymphatic pathway draining the primary site of a tumor.~   "
220557|NCT00671905|"~     The investigators have recently shown that anatomic ganglionated plexi (GP) ablation is~     inferior to circumferential pulmonary vein (PV) ablation for the treatment of paroxysmal AF.~     In this study, however, 26% of patients subjected to GP ablation alone without~     circumferential lesions were free of AF-recurrence up to one year after the ablation~     procedure. The investigators hypothesized that a combination of circumferential ablation with~     high-frequency-stimulation-identified GP ablation is superior to conventional circumferential~     ablation for the prevention of recurrences of paroxysmal atrial fibrillation (AF). The~     investigators are, therefore, conducting a randomized study comparing conventional~     circumferential ablation to a combination of circumferential ablation plus specific right and~     left atrial GP ablation in patients with drug-refractory paroxysmal AF.~   "
220558|NCT00671892|"~     The overall goal of this project is to identify genes that are involved in the development of~     airflow obstruction and airway inflammation in asthmatics, and to determine whether~     polymorphisms in these differentially expressed genes predispose individuals to develop~     asthma. In this project, we hypothesize that polymorphisms of genes expressed by the airway~     epithelia in asthmatics following specific airway challenges predispose individuals to the~     development of asthma.~   "
220559|NCT00671879|"~     The purpose of this study is to determine if two sustained released formulations of~     carisoprodol are more effective than placebo.~   "
220560|NCT00671866|"~     During 1987-1991, WHO supported studies of exposures and short term neurobehavioral effects~     in a cohort (n=200) with occupational and community exposures to pesticide drift containing~     organophosphates from orchards and cotton fields in the Hula Valley. We aim (1) to re-examine~     neurobehavioral outcomes in members of the original cohort and (2) to examine cognitive~     effects in children with residential exposures. In adults, we will carry out assays of alkyl~     phosphates, PON1 (paraoxonase-1), NTE (Neuropathy Target Esterase), neurobehavioral tests of~     cognitive and performance skills, nerve conduction measurements and mood status. We will~     carry out Psycho-Didactic tests in children. The findings will advance knowledge on delayed~     term health effects of lengthy everyday exposure to OP pesticides and guide regulatory~     policy.~   "
220576|NCT00671632|"~     The purpose of this study is to determine the relative abuse potential of ramelteon, once~     daily (QD), compared to triazolam in subjects with a history of drug abuse.~   "
220561|NCT00671853|"~     The primary objective is to test the hypothesis that Quetiapine XR (Extended Release)~     monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression~     and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a~     substance use disorder. The secondary aim is to generate an estimate of effect size to power~     a definitive large-scale, multi-site collaborative R01 and to configure the use of the~     primary and secondary outcome measures in the definitive large-scale study.~   "
220562|NCT00671827|"~     The goal of this observational study is to collect information about the length of surgery,~     the procedures performed during surgery, and any possible side effects of robot-assisted~     gynecologic cancer surgeries. The researchers also want to learn if patients who have~     robot-assisted surgeries have fewer complications during recovery.~   "
220563|NCT00671814|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     single rising oral doses and multiple oral doses of TR-701~   "
220564|NCT00671801|"~     The goal of this clinical research study is to find the highest tolerable dose of~     lenalidomide combined with Camptosar (irinotecan) as well as to see if this drug combination~     can help control malignant gliomas.~      Researchers will also study if a special magnetic resonance imaging (MRI) technique (dynamic~     MRI scan) is useful in looking at the effect of treatment on the tumor. Another goal is to~     learn the effect of lenalidomide on tumor tissue in patients who need surgery for the~     disease.~   "
220565|NCT00671788|"~     Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. This phase II trial is studying how well dasatinib works in treating patients with~     persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary~     peritoneal cancer.~   "
220566|NCT00671775|"~     There is growing evidence that obesity is associated with adverse neurocognitive outcome.~     Recent studies demonstrate that elevated body mass index (BMI) is an independent risk factor~     for Alzheimer's disease, structural brain abnormalities, and cognitive dysfunction in older~     adults. Preliminary work from our lab extends these findings and shows structural brain~     differences and cognitive dysfunction also exist in obese young and middle-aged adults.~      Bariatric surgery is increasingly viewed as an effective intervention for morbid obesity,~     though its effects on cognition are unknown. Post-operative nutritional deficiencies are~     common and can adversely impact cognitive performance. However, substantial weight loss~     resolves or improves many medical conditions with reversible cognitive effects, suggesting~     bariatric surgery may provide cognitive benefits.~      No study to date has examined the cognitive effects of bariatric surgery. To do so, the~     proposed study will prospectively assess cognitive performance in 125 bariatric surgery~     patients enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS) project and 125~     matched controls. Bariatric surgery patients will complete a computerized cognitive test~     battery at four time points: pre-operatively, 12 weeks post-operatively, 12 months~     post-operatively, and 24 months post-operatively. Matched control participants will complete~     the test battery at similar intervals. Demographic, medical, and psychosocial information~     will be collected to elucidate possible mechanisms of change. We hypothesize that the~     substantial weight loss following bariatric surgery will be associated with improved~     cognitive performance.~   "
220567|NCT00671749|"~     This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel~     0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel)~     applied in the morning, in Subjects with Acne vulgaris.~   "
220568|NCT00671736|"~     This is a dose-finding study for the investigational product Lancovutide (Moli1901) in the~     exploratory phase IIb to establish minimum effective dose, optimal dose, and maximum safe~     dose. Additionally, the tolerability of Moli1901 shall be investigated.~   "
220569|NCT00671723|"~     Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it~     is currently heavily used in this population. In fact, per evidence of barcode scanning via~     Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non~     Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed~     that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline .~     Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is~     an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic~     fibrosis.~      We hereby propose a prospective randomized trial to compare the efficacy of hypertonic~     saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis,~     mechanically ventilated patient.~   "
220570|NCT00671710|"~     Tumors of the central nervous system are potentially curable. For tumors of comparable~     histology and grade, resectability is the most important prognostic factor affecting survival~     particularly in children. However, the infiltrative nature of the malignant cells produces~     indistinct borders between normal and malignant tissues, and the lack of easily identifiable~     tumor margins confounds attempts toward total resection. The investigators propose to~     identify the borders of tumors intraoperatively using protoporphyrin fluorescence of the~     malignant cells and thereby provide more complete tumor resection.~   "
220571|NCT00671697|"~     This study is designed to test the combination of decitabine, arsenic trioxide and ascorbic~     acid in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia~   "
220572|NCT00671684|"~     The purpose of this study is to compare the diagnostic yield with endoscopic mucosal~     resection (EMR) in hirschsprung's disease versus that of standard rectal suction biopsy. In~     order to compare EMR versus rectal suction biopsy, patients' diagnostic specimens will be~     analyzed by tissue size, the presence of submucosal tissue, and positive acteylcholinesterase~     staining. Additionally, the proportion of patients who would have required subsequent full~     thickness surgical biopsy with each technique will be compared. Biopsy results will be~     compared with clinical data including history, Bristol stool scale, anorectal manometry~     results and SITZ markers studies. Finally, the estimated costs that would have been incurred~     with each method will be evaluated.~   "
220573|NCT00671671|"~     Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics,~     safety and efficacy in subjects with no or inadequate response to prior treatment.~   "
220574|NCT00671658|"~     The goal of this clinical research study is to learn if intensive chemotherapy (with~     monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed~     by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic~     leukemia (ALL) or lymphoblastic lymphoma.~   "
220577|NCT00671619|"~     Objectives:~      To evaluate the safety, tolerability and pharmacokinetics of ESBA105 administered topically~     to the eye for up to 28 days in healthy volunteers.~      To determine the systemic exposure to ESBA105 upon single and repeated-dose topical~     application to the eye in healthy volunteers.~   "
220578|NCT00671606|"~     The goal of this clinical research study is to learn if a procedure called intraoperative~     (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients~     with endometrial cancer.~   "
220579|NCT00671593|"~     The purpose of this study is to identify the genes in important airway cells that are~     specifically expressed following inhalation of house dust mite allergen among study subjects~     with either allergic asthma or healthy normal phenotypes. This approach is designed to~     identify novel genes associated with both asthma pathogenesis (differentially expressed in~     the exposure-response study) and asthma susceptibility (genetically associated with asthma in~     a linkage/association study) for drug targets.~   "
220580|NCT00671580|"~     The purpose of this study is to evaluate the potential effect and safety of two different~     doses of PZ-601 and to compare this with another antibiotic that is approved by the US Food~     and Drug Administration (also known as FDA) to treat adults with skin and skin structure~     infections.~   "
220581|NCT00671567|"~     The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily~     (QD), in adult subjects with chronic insomnia.~   "
220582|NCT00671554|"~     The purpose of this study is to determine if treatment with the autologous cellular vaccine,~     Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage~     IV malignant melanoma.~   "
220583|NCT00671541|"~     The purpose of this study is to evaluate a stenting material called Nasopore. This is a~     synthetic material approved by FDA for use as a stent in postoperative sinus surgery~     patients. This study will compare the Nasopore stent to other approved stenting materials.~   "
220584|NCT00671528|"~     This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial~     comparing three creams in the treatment of impetiginous eczema:~        -  Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin~          sulfate)~        -  Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream~        -  Arm C: Betamethasone diproprionate cream~      At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1~     randomization ratio to receive one of the three possible treatments for a maximum period of~     28 days or until 5 days after total remission of the signs and symptoms, but never more than~     28 days. Assessments will be made of level of improvement of the target area in each~     treatment group, number of days for total remission, and safety profile.~      Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned~     participants were enrolled). Statistical analyses were not performed.~      Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were~     initiated.~   "
220585|NCT00671515|"~     The goal of this study is to begin to test whether or not pioglitazone, an FDA approved~     medication used to treat high blood sugar, may be safe and effective in treating Major~     Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).~   "
220586|NCT00671502|"~     The purpose of this study is to determine if two sustained released formulations of~     carisoprodol are more effective than placebo.~   "
220587|NCT00671489|"~     The purpose of this study is to evaluate the efficacy and safety of Polyunsaturated Fatty~     Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental~     injuries.~   "
220588|NCT00671476|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~      PURPOSE: This clinical trial is studying the side effects of doxorubicin hydrochloride~     liposome and to see how well it works in treating women with ductal carcinoma in situ~     undergoing surgery.~   "
220589|NCT00671463|"~     The purpose of this study is to investigate an intervention to prevent complications after~     pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before~     surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are~     common after pancreas surgery and can result in serious problems and post-operative pain. The~     study will compare two groups. One group will have the stent before surgery, and the other~     group will have standard pancreas surgery, no endoscopy, and no stent.~   "
220590|NCT00671450|"~     In an on-going study of visual characteristics of personnel diagnosed with a mild traumatic~     brain injury (MTBI) related to their service in Iraq and Afghanistan we found a high rate of~     binocular vision problems (such as double/blurry vision, reading difficult, etc.). These~     individuals are also usually diagnosed with post traumatic stress disorder (PTSD). PTSD is~     known to cause some vision symptoms. We wish to conduct this study on individuals with PTSD~     (but not an MTBI) to see if they have symptoms similar to those in individuals who have MTBI.~     This will provide us with information useful in determining the specific cause of the visual~     symptoms in the MTBI population.~   "
220591|NCT00671437|"~     The purpose of this study is to collect data and evaluate how the tumor is broken down in~     response to standard of care cetuximab treatment by evaluating the FDG-PET/CT scans,~     toxicity, see how well the FDG-PET/CT scans predict response to treatment and survival.~   "
220592|NCT00671424|"~     Many patients with type 2 diabetes also have conditions that are treated with diuretics. The~     patients may also be treated with GSK189075 for their diabetes. This study is planned to~     assess possible effects of administering GSK189075 in combination with two frequently used~     diuretics.~   "
220593|NCT00671411|"~     The purpose of this study is to evaluate the blood flow in kidney masses by using ultrasound~     microbubble contrast material, and to see if results from ultrasound contrast studies can~     predict if a kidney mass is benign or malignant. Patterns of blood flow in the kidney mass~     will be examined to see if:~        1. benign kidney masses can be distinguished from kidney cancers and~        2. if slow growing, lower risk cancers have different blood flow compared to clear cell~          cancer which is the most common type of kidney cancer.~   "
220594|NCT00671398|"~     The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily~     (QD), in healthy subjects within a sleep lab.~   "
220595|NCT00671385|"~     The purposes of this study is to establish normal optical values of breast tissue in the~     general population. This will allow for establishing normals for breast composition, and is~     expected to be useful in the classification of breast lesions into groups such as cysts,~     benign growths, inflammatory lesions, and possibly early breast cancer.~   "
220596|NCT00671372|"~     This study will assess the safety and pharmacokinetics of adding dulanermin to~     Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus~     bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy).~   "
220597|NCT00671359|"~     This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of~     TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.~   "
220598|NCT00671346|"~     Two large homocysteine-lowering B-vitamin intervention trials have been performed in Norway~     during the period 1998 to 2005, NORVIT and WENBIT. The main objective in these trials was to~     study the clinical effects of homocysteine-lowering therapy with folic acid and vitamin B12~     in patients with established coronary artery disease. Follow-up was terminated for NORVIT on~     Marc 31st 2004 and for WENBIT October 5th 2005, and none of the two trials proved any~     protective effect of the B-vitamin intervention on cardiovascular outcomes.~      There is so far no data on possible long-term effects following years of such B-vitamin~     treatment.~      Thus, the main objective of the combinded NORVIT-WENBIT study will will be to evaluate the~     long-term effect of the B-vitamin intervention on incident life-style diseases including~     cardiovascular disease, diabetes, osteoporotic fractures and cancer.~      A secondary object will be the identification of risk phenotypes or genotypes, and if such~     risk associations are midified by the B-vitamin intervention~   "
220599|NCT00671333|"~     The purpose of this study is to compare the effectiveness of two types of operative treatment~     in terms of resolving symptoms, improving function and also with respect to x-ray outcomes.~      The hypothesis is that insertion of a spacer will provide similar symptomatic relief, but~     improved long term gains in key and tripod pinch strength when compared to LRTI.~   "
220600|NCT00671320|"~     To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day~     until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in~     treating acute first or second degree ankle sprain. The study also compared valdecoxib and~     diclofenac with respect to time to onset of pain relief (measured after the first dose),~     tolerability (adverse events) and time to return to Normal Function/Activity, among other~     measures.~   "
220601|NCT00671307|"~     This study is designed to assess the pharmacokinetics and safety of an infusion of a single~     dose of recombinant plasma gelsolin (rhu-pGelsolin) when given to patients admitted to the~     Intensive Care Unit with documented low levels of natural gelsolin. It is believed that this~     drug will raise the gelsolin levels in these patients and decrease the probability that they~     will develop complications from their underlying disease such as organ system failure or~     death.~   "
220602|NCT00671294|"~     This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily~     (QD), in elderly subjects with chronic insomnia.~   "
220603|NCT00671281|"~     Sinus surgery is a common, day surgery procedure performed by general and subspecialty~     trained otolaryngologists. In most cases, this is a safe surgery with a low incidence of~     complications. When there is significant bleeding or enough bleeding to obscure important~     anatomical landmarks, there is a higher chance of complications. These complications can~     include blindness, meningitis or cerebrospinal fluid leak. Our hypothesis is that in patients~     taking oral tranexamic acid three days before surgery and six days after, there will be less~     intraoperative bleeding, better surgical visualization and less postoperative bleeding~     events.~   "
220604|NCT00671268|"~     Efficacy and Safety from a high-dosed subcutaneous recombinant preparation~   "
220605|NCT00671255|"~     This purpose of this study is to evaluate the safety and effectiveness of Ramelteon, once~     daily (QD), in elderly participants with chronic insomnia.~   "
220606|NCT00671242|"~     Purpose: L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for PET. We have~     conducted a clinicopathologic study to elucidate the correlation of angiogenesis with 18F-FMT~     and 18F-FDG uptake in the patients with non-small cell lung cancer (NSCLC).~      Method: Thirty-seven NSCLC patients were enrolled in this study, and a pair of PET study with~     18F-FMT and 18F-FDG was performed. Uptake of PET tracers was evaluated with standardized~     uptake value. VEGF, CD31, CD34, LAT1 and Ki-67 labeling index of the resected tumors were~     analyzed by immunohistochemical staining, and correlated with the clinicopathologic variables~     and the uptake of PET tracers.~   "
220607|NCT00671229|"~     The purpose of the study is to determine the role of nitric oxide (NO) in asthma. We~     determine the effect of promoter polymorphisms in the gene for the NO producing enzyme,~     nitric oxide synthase (NOS2), on exhaled NO in healthy African Americans and Caucasians. We~     compare exhaled NO levels between African Americans and Caucasians. Information on race or~     ethnicity, serum samples, blood pressure, exhaled breath condensate and health questionnaires~     will be collected.~   "
220608|NCT00671216|"~     GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary~     Disease. Development of these two inhaled drugs as a combination therapy would have potential~     for improved patient benefit as they both work through different mechanisms and the combined~     bronchodilatory effect might be additive. This study will look at the this combination, for~     the first time, in healthy subjects.~   "
220609|NCT00671203|"~     Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their~     intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die~     before leaving the hospital. A device developed by Spectros, called T-Stat, is approved by~     the US FDA to detect ischemia, and has been reported to detect ischemia in AAA aneurysm~     surgery and stenting, allowing the surgeon or interventional radiologist to take action~     quickly, while the colon ischemia is still treatable.~      This purpose of this study is to establish how T-Stat can best be used to prevent deaths.~   "
220610|NCT00671190|"~     The purpose of this study is to determine the phase-advance in circadian rhythms in healthy~     adults subjects taking ramelteon, once daily (QD).~   "
220653|NCT00670618|"~     Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in~     orthodontic patients during fixed appliances.~   "
253739|NCT00230100|"~     The purpose of this study was to develop a gender-specific 12-session, manual-based relapse~     prevention group for women with substance use disorders (SUDs).~   "
220611|NCT00671177|"~     Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the~     rectum and left colon through the colonoscope as it is being inserted during a colonoscopy~     examination can allow easier endoscope advancement. This method may prevent stretching of the~     colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort~     and cooperation, may increase the efficiency and success rate of complete colonoscopy. The~     purpose of the study is to test the efficacy of the water immersion technique in patients~     colonoscopy.~   "
220612|NCT00671151|"~     Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline~     on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and~     acetylation status of nuclear histones are to be studied.Design: controlled, prospective and~     randomized study with or without theophylline, a potent HDAC activator.Objectives: 1) To~     determine NF-kB activation, histone deacetylase (HDAC) and histone acetyl-transferase (HAT)~     activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3~     months later, once stability is achieved. To correlate these measurements with inflammatory~     and oxidative stress markers and with pulmonary function and clinical variables. 2) To assess~     the effect of theophylline on previous molecular, functional and clinical data. Method: 25~     patients with COPD will be recruited during an episode of exacerbation requiring~     hospitalization. NF-kB activation, HDAC and HAT activity, markers of inflammation and~     oxidative stress will be determined with specific assays. These determinations will be~     repeated once the patient is stable and compared with smokers and non smoker controls with~     normal lung function~   "
220613|NCT00671138|"~     The disappearance of intestinal parasites from humans in developed countries may be~     responsible for the upsurge in many diseases including Celiac Disease, Crohn's, ulcerative~     colitis, asthma and hay fever. A parasite's survival relies on its ability to interfere with~     the host's immune response. The mechanisms employed to do this are similar to those required~     by a person to regulate against the so-called autoimmune disorders, diseases in which the~     system turns on itself. The investigators suspect that when parasites are excluded from the~     environment, some individuals become sufficiently self-reactive to develop an autoimmune~     disease. American researchers have successfully treated patients with Crohn's and ulcerative~     colitis using a pig whipworm (Trichuris suis). The investigators have undertaken a similar~     preliminary study using a human hookworm in Crohn's patients.~      Using a small group of healthy people with celiac disease, the investigators will test if a~     human hookworm, Necator americanus, inhibits immune responsiveness to gluten. Celiac disease~     is a very common autoimmune-like disease (1% of Americans are affected although only a~     minority are aware they have the condition). In this condition, an individual becomes~     reactive to gluten, a protein in foods derived from wheat, barley, oats and rye.~      What makes celiac disease such a good model for Crohn's disease is that similar immune~     changes are common to both, but in celiac disease the people are usually well, are not taking~     powerful immune suppressive drugs and the provocative antigens (the molecules that engage the~     immune system and provoke the disease) are known and can be excluded or introduced. As well~     as being of direct benefit to people with celiac disease, this study may give direction as to~     the potential of this parasite to manage inflammatory bowel disease.~      People with proven celiac disease who live in Brisbane, a modern Australian city, will be~     invited to participate. Enrollment will require that the candidate has been avoiding gluten~     for six months.~      The study is a blinded study (where the researchers and study subjects do not know who has~     gotten the parasites) aimed at comparing the disease activity and immunity after a controlled~     breach of the gluten-free diet in individuals with celiac disease, before and after hookworm~     infection. The disease severity and the immune system of celiac subjects before and after~     being inoculated with N. americanus will be examined using conventional and experimental~     investigations. This group's immunity will be compared to that of a group of matched, celiac~     control subjects (not infected with hookworm), before and after eating four pieces of~     standard white bread each day for three to five days. Twenty people, ten subjects per arm,~     will be recruited. Ten larvae initially, then five more after twelve weeks will be placed on~     the skin under a light dressing for thirty minutes.~      The investigators aim to test whether the hookworm infection will change the immune processes~     and suppress gluten sensitivity in people with celiac disease. Outcomes to be measured will~     be those that reflect the activity of celiac disease.~   "
220614|NCT00671125|"~     The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily~     (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of~     sleep~   "
220615|NCT00671112|"~     RATIONALE: Everolimus and bortezomib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with bortezomib in treating patients with relapsed or refractory lymphoma.~   "
220616|NCT00671099|"~     The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid~     for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental~     injuries.~   "
220617|NCT00671086|"~     The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD),~     in subjects with chronic insomnia.~   "
220618|NCT00671073|"~     This study will assess the safety and efficacy of a range of oglemilast doses. The study will~     be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to~     one of three doses of oglemilast or placebo.~   "
220619|NCT00671060|"~     The purpose of the proposed study is to test - in a randomized, blinded trial - two different~     doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for~     fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of~     pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely~     evacuation is vital in order to avoid the possibility of, among other things, potentially~     life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these~     cases include dilatation and evacuation (D&E) surgery (in less advanced pregnancies) and~     labor induction with a variety of products. Misoprostol has been demonstrated to be as~     effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this~     indication in a number of small, non-FDA-approved trials which have been published in the~     peer-reviewed literature. In the absence of more formal study of this treatment, however,~     dosages are not standardized, pathways of administration vary, and other uncertainties~     linger. The purpose of the protocol proposed herein is to formally establish, via a~     randomized, double-blinded study, the safety and effectiveness of misoprostol for this~     indication, and to compare the value of two distinct doses, so that providers may~     henceforward proceed with greater authority and confidence.~   "
220620|NCT00671047|"~     The goal of this study is to enable the study sponsor to develop a new blood test method for~     clinicians to accurately predict which individuals with lupus will flare, when the flare will~     occur, and flare severity. Ultimately such a newly derived test would allow treating~     physicians to start pre-emptive therapy early, with the goal of achieving remission quickly~     and with a shorter duration of treatment; identify individuals who will have less severe~     flares and will thus require less aggressive treatments; or intensify and lengthen treatment~     for those individuals who will need such therapy.~      The design of this study is to follow individuals with a known diagnosis of SLE for changes~     in disease activity during the course of one year of observation. Clinical data and blood and~     urine samples will be collected at scheduled monthly visits. The clinical data and blood~     samples will be used for identifying gene expression profile(s) that are associated with~     increases in SLE disease activity (lupus flares).~   "
220621|NCT00671034|"~     This randomized clinical trial is studying giving calaspargase pegol together with~     combination chemotherapy to see how well it works compared with giving pegaspargase together~     with combination chemotherapy in treating younger patients with newly diagnosed high-risk~     acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) may kill more cancer cells.~   "
220622|NCT00671021|"~     The well established importance of regular aspirin administration stands on firm grounds, as~     large meta-analyses have shown this therapy to significantly reduce the risk of death.~     However, not all patients benefit of aspirin administration to the same extent, thus~     high-lighting a sub-population of patients with inadequate platelet response to ASA. The~     mechanisms underlying reduced ASA efficacy remain elusive. A recent report has suggested that~     platelets, long believed to be incapable of de novo protein synthesis, may retain their~     ability to form the cyclooxygenase enzyme, once it has been inactivated by aspirin. This may~     explain the inefficacy of the drug to induce sustained platelet inhibition in certain~     patients.~      The current study aims to evaluate, in patients suffering from stable coronary artery~     disease, the stability of platelet inhibition by aspirin during the normal once daily dosing~     regimen.~   "
220623|NCT00671008|"~     This trial is conducted in Europe.~      The aim of this observational study is to evaluate the glycaemic control in patients with~     type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.~   "
220624|NCT00670995|"~     There have been a number of tobacco prevention programs developed and tested in the past few~     years, and some of the comprehensive programs have been promoted by the Office on Smoking and~     Health at the Centers for Disease Control (CDC). However, the use of these programs and~     integration into school-based curriculum has been lacking due to a number of factors. We are~     proposing to develop an interactive computer-based program for tobacco prevention aimed at~     middle school students. The CD-ROM is designed to be an adjunct to the existing health~     education curriculum provided for 6th through 8th grade students.~   "
220625|NCT00670982|"~     The purpose of this research study is to determine the effects of the combination of~     bevacizumab, vinorelbine, and trastuzumab on participants and their cancer.~   "
220626|NCT00670969|"~     The purpose of this study is to determine, in a group of overweight or obese volunteers, if a~     handheld indirect calorimeter can accurately measures oxygen consumption to determine resting~     metabolic rate compared to a portable indirect calorimeter.~   "
220627|NCT00670956|"~     Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung~     tissue. Administration of maternal steroids in the mid-trimester may stop the growth or~     decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in~     fetuses with large CCAMs. This is a prospective, blinded, randomized trial comparing~     administration of a single course of antenatal steroids (Betamethasone) to control (i.e.,~     placebo). The primary outcome variable will be incidence of hydrops. One month postnatal~     survival and relative size of the CCAM as determined by CCAM volume:head circumference ratio~     (CVR) between treatment/no treatment groups will be secondary outcome variables. Change in~     size of CCAM will be serially followed for both groups with individual growth curves being~     plotted prenatally and these will be compared with pathology weigh and volume to evaluate~     treatment effect. Other prenatal data collected will include: incidence of polyhydramnios,~     incidence of premature rupture of membranes, incidence of material complications. We will~     also compare mode of delivery, postnatal respiratory compromise, need for resection in the~     first week of life, and occurrence of complications during newborn administration~   "
220628|NCT00670943|"~     The well established importance of regular administration of antiplatelet drugs stands on~     firm grounds, as large meta-analyses have shown these therapies to significantly reduce the~     risk of death. Plavix® (clopidogrel) is widely used following coronary angioplasty, to reduce~     the risk of periprocedural thrombotic complications, for up to one year. As the current~     recommendations suggest clopidogrel use for no longer than one year, the drug is normally~     discontinued within that period. In the limited state of knowledge on antiplatelet drug~     withdrawal, an early sound of alarm has risen from early thromboembolic complications~     reported after the interruption of antiplatelet treatment used in prevention of ischemic~     vascular disease. Although little information is available, discontinuation of~     thienopyridines has been associated with increased thromboembolic complications, mainly acute~     stent thrombosis. These complications may signal a platelet sensitization effect to~     aggregating stimuli by antiplatelet drugs taken chronically.~      The current study aims to evaluate the impact of clopidogrel discontinuation on platelet~     function, in order to shed light on underlying mechanisms leading to increased risk of acute~     thrombo-occlusive events.~   "
220629|NCT00670930|"~     This study aims to investigate the effect of omalizumab on the number of tissue eosinophils~     and other markers of airway inflammation and remodeling, including thickness of the lamina~     reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway~     inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists.~     This study will also investigate the correlation between systemic and pulmonary inflammation,~     and the correlation between clinical outcomes and changes within the tissue, to assist in the~     future identification of patients with tissue eosinophilia and their response to treatment,~     without the need for invasive bronchoscopy.~   "
220630|NCT00670917|"~     RATIONALE: Acupressure may help relieve pain in cancer patients undergoing bone marrow~     aspiration and biopsy. It is not yet known whether magnetic acupressure is more effective~     than sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration~     and biopsy.~      PURPOSE: This randomized clinical trial is studying magnetic acupressure to see how well it~     works compared with sham acupressure in reducing pain in cancer patients undergoing bone~     marrow aspiration and biopsy.~   "
220631|NCT00670904|"~     This randomized trial compared the effectiveness of a three session pharmacist-delivered~     group program for smoking versus one 5 to 10 minute standard care session delivered over the~     telephone on 7-day point prevalence quit rates. Participants in both groups were offered~     their choice of bupropion IR or nicotine patch at no cost. At 6 months after the established~     quit date, self-reported cessation was biochemically verified using tests for urinary~     cotinine.~   "
220632|NCT00670891|"~     Autism is a developmental and behavioral pattern which includes the triad of impairments, 1.~     social interaction 2. social communication 3. imagination. Inevitable difficulties in the~     treatment, managing and handle with autistic children are the main problems. Their memories~     are seemingly in picture or photo records, which are difference from normal population. There~     are many concepts but no concise in causative factors, including useful treatments, useless~     and prolong remaining in many studies.~      HBOT (Hyperbaric Oxygen Therapy) is a quite modern treatment in Thailand for nitrogen~     imbalance (decompression sickness syndrome or Caisson disease). How can we apply it to treat~     the autism? A hypothesis shows evidence that neurons surrounding the permanently damaged~     epicenter of injury can be reactivated with increased oxygen. Oxygen exists in the blood in~     two forms, combined with hemoglobin and dissolved in plasma. More oxygen is transported by~     hemoglobin, but oxygen is delivered to the tissues in dissolved form by the liquid portion of~     blood. HBOT can increase in plasma oxygen to the tissues including the brain. A little change~     in oxygen can make the better improvements in : cognitive ability, socialization, sleep,~     calmness, decreased stimming and language. It can make increased in Glutathione (GSH), and~     Glutathione (GSH) can decreased in oxidative stress with effected to remove metal compounds~     (mercury) to improve the autism.~      This clinical trial study divided into 3 group populations 1. general autism 2.~     post-treatment chiropractic autism 3. medicated autism. This comparative study shows the~     major clinical symptoms before and after the treatment with HBOT. This study results and~     analysis are the most important for our further projects planning.~   "
254219|NCT00223561|"~     The primary purpose of this study is to determine the effects of methylphenidate versus~     placebo on driving ability of adult ADHD patients.~   "
220633|NCT00670878|"~     This is an open-label, multicenter randomized controlled, Phase III study comparing the~     disease free survival after randomisation in patients treated with 3 cycles of~     Epirubicin-Fluorouracil-Cyclophosphamide (FEC)-chemotherapy, followed by 3 cycles of~     Docetaxel (D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil- Cyclophosphamide~     (FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)- chemotherapy. Patients will be~     required to have HER2-neu positive disease and histopathological proof of axillary lymph node~     metastases (pN1-3) or high risk node negative, defined as: pT>=2 or histopathological grade~     3, or age <= 35 or negative hormone receptor', but are not allowed to have evidence of~     distant disease. Patients will have to be entered into the study no later than 6 weeks after~     complete resection of the primary tumor. No other antineoplastic treatment other than~     surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be~     allowed prior to study entry and during the course of the study.~   "
220634|NCT00670865|"~     The purpose of this study is to determine whether a semi-automated electronic patient~     discharge summary program leads to increased community physician and housestaff satisfaction~     and patient outcomes as compared to conventional discharge reports.~   "
220635|NCT00670852|"~     To investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis~     correlates with bony apposition on computed tomography scans, decreased radiolucent lines and~     component loosening, and functional outcomes. We hypothesize that by utilizing autologous~     bone graft from the resected humeral head, placed around the anchor peg glenoid prosthesis at~     implantation, there is a low incidence of glenoid loosening. We suggest that the absence of~     radiolucent lines correlated with excellent shoulder function.~   "
220636|NCT00670839|"~     HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic~     and severe liver disease, with a major risk of cirrhosis and liver cancer.~      However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected~     patients, compared to non HIV-infected individuals, and, in case of response, its durability~     has to be carefully followed up. This study compares the efficacy of two strategies of~     revaccination in HIV-infected patients who didn't respond to previous hepatitis B~     vaccination. Failure is defined by two conditions: non response to the primary immunization~     (2 to 4 single-dose injections received before the screening visit) and failure to a single~     20 µg boost before being included in the study.~   "
220637|NCT00670826|"~     Medications used to put people to sleep during surgical procedures also cause changes in the~     body's ability to control its temperature. These changes can make a person's temperature drop~     below normal. To minimize this drop in body temperature, different types of body warming~     products are used during surgery. This study is designed to compare the the temperatures of~     people under general anesthesia after 60 minutes of warming with each product. The study~     hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will~     decrease less in the first 60 minutes of warming time than people warmed with the Arizant~     Bair Hugger System.~   "
220638|NCT00670813|"~     The study aims to investigate whether the administration of the stimulant modafinil during a~     40 hour sleep deprivation period in depressed patients can intensify the antidepressant~     effect of the sleep deprivation as assessed by a reduction in the Hamilton Depression score~     (HAMD, 6-item version). We postulate that this also correlates with a reduction of the~     polysomnographically assessed overall amount of sleep during this period.~   "
220639|NCT00670800|"~     The purpose of this study is to evaluate the effects of insulin resistance on brain function~     in women with Polycystic Ovary Syndrome (PCOS). PCOS affected women will be evaluated prior~     to and following 4-month treatment with Metformin. Additionally, brain function in women with~     PCOS will be compared to the brain activity in normal control subjects with regular menstrual~     cycles.~   "
220640|NCT00670787|"~     The purpose of the study is to determine whether combination pill of losartan potassium and~     hydrochlorothiazide will improve medication compliance among patients with high blood~     pressure.~   "
220641|NCT00670774|"~     A strongly positive crossmatch has long been considered an absolute contraindication to~     kidney transplantation and most patients with anti-HLA antibody never were able to receive a~     kidney transplant. Over the past decade, significant progress has been made in overcoming~     early antibody-mediated renal allograft injury. Our group has performed more than 200 such~     transplants providing the possibility of transplant to previously untransplantable patients.~     Despite our best efforts, transplantation in these patients is still complicated by a high~     rate of acute humoral rejection.~      Patients included in this study will be those who have demonstrable anti-HLA antibody~     specific for their living donor. It is our hypothesis that blockade of terminal complement~     activation at the time of transplant in combination with our current protocols will reduce~     the incidence of AHR in patients with anti-donor HLA antibody.~   "
220642|NCT00670761|"~     This randomized study will examine the efficacy, safety and acceptability of misoprostol for~     treatment of incomplete abortion.~      Women diagnosed with incomplete abortion will be randomized to receive one of the following~     regimens:~      In Tanzania and Mozambique:~        1. 600 mcg of oral misoprostol in one dose, or~        2. Standard surgical treatment (MVA)~      In Moldova and Madagascar:~        1. 600 mcg of oral misoprostol in one dose, or~        2. 400 mcg of sublingual misoprostol in one dose.~      In Burkina Faso and Vietnam:~      1. 400 mcg of sublingual misoprostol in one dose.~      We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual~     misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.~   "
220654|NCT00670605|"~     RATIONALE: Gathering information about the number of young patients with cancer and the~     outcome of these patients may help doctors learn more about cancer.~      PURPOSE: This research study is looking at the medical records of young patients undergoing~     cancer treatment at the Vanderbilt-Ingram Cancer Center to determine how often cancer occurs~     and the outcome of these patients.~   "
220655|NCT00670592|"~     This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults~     with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.~   "
220728|NCT00669604|"~     Prevention of HIV-1 transmission from mother-to-child by non-breast-feeding is complicated by~     increased infant mortality in developing countries. However, extensive counselling about~     formula feeding turned out safe in Vietnam, a middle-income country.Extensive counselling~     together with formula feeding and antiretroviral therapy reduced vertical transmission of~     HIV-1 considerably.~   "
220643|NCT00670748|"~     Background:~      -This study uses an experimental cancer treatment that uses the patient s own lymphocytes~     (type of white blood cell), which are specially selected and genetically modified to target~     and destroy their tumor.~      Objectives:~      -To test the safety of the treatment and determine if it can cause the patient s tumor to~     shrink.~      Eligibility:~        -  Patients greater than 18 years and less than or equal to 66 years of age whose cancer~          has spread beyond the original site and does not respond to standard treatment.~        -  Patients have tissue type human leukocyte antigen (HLA)-A*0201.~        -  Patients cancer cells have the ESO-1 gene.~      Design:~        -  Workup: Patients have scans, x-rays, laboratory tests, and other tests as needed.~        -  Patients have leukapheresis to collect cells for laboratory treatment and later~          reinfusion. For this procedure, whole blood is collected thorough a tube in a vein, the~          desired cells are extracted from the blood, and the rest of the blood is returned to the~          patient.~        -  Chemotherapy: Patients have low-dose chemotherapy for 1 week to prepare the immune~          system to receive the treated lymphocytes.~        -  Cell infusion and aldesleukin (IL-2) treatment: Patients receive the lymphocytes by a~          30-minute infusion through a vein. Starting within 24 hours of the infusion, they~          receive high-dose aldesleukin infusions every 8 hours for up to 5 days (maximum15~          doses).~        -  Recovery: Patients rest for 1 to 2 weeks to recover from the effects of chemotherapy and~          aldesleukin.~        -  Tumor biopsy: Patients may be asked to undergo a biopsy (surgical removal of a small~          piece of tumor) after treatment to look at the effects of treatment on the immune cells~          in the tumor.~        -  Follow-up: After treatment is completed, patients return to the clinic once a month for~          several months for physical examinations, a review of side effects, laboratory tests and~          scans. They may undergo leukapheresis at some visits to look at the effect of treatment~          on the immune system and check the viability of the infused cells. Patients then return~          to the National Institute of Health (NIH) clinic once a year for 5 years and then~          complete a follow-up questionnaire for another 10 years.~        -  Retreatment: Patients whose tumor shrinks or disappears following treatment and then~          recurs may receive one additional treatment, using the same regimen of chemotherapy,~          lymphocyte infusion and IL-2 treatment.~   "
220644|NCT00670735|"~     The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic~     funding to conduct multi-institutional research (clinical trials and observational studies)~     on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received~     an NIH NINDS Challenge Grant to support the network infrastructure which allows for the~     conduct of this and other network studies. The HCRN consists of multiple Clinical Centers and~     the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all~     neurosurgical hydrocephalus events from the network Clinical Centers, and create a database~     to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two~     main purposes: 1) it will help investigators understand the variability, progression, and~     current treatment practices for hydrocephalus in children, with an ultimate goal of better~     guiding and assessing therapeutic intervention and providing recommendations on patient care~     and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and~     study design (i.e. preliminary power analyses, recruitment projections) for studies under~     development by the HCRN. This multi-institutional database will be maintained throughout the~     lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over~     time. The Core Data Project will be an invaluable resource to the HCRN and will help~     stimulate new research protocols, identify potential need for future expansion of the network~     to incorporate additional patient populations, and provide a descriptive understanding of~     children with hydrocephalus cared for within the network.~   "
220645|NCT00670722|"~     This study is conducted in Europe. An observational study evaluating the blood glucose~     control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment~     of Type 2 diabetes mellitus in Czech Republic.~   "
220646|NCT00670709|"~     The pace of basic science research defining the mechanisms of selective neuronal degeneration~     in Huntington disease (HD) has far exceeded the pace of translation of this information into~     clinically effective treatments for the disease. One reason for this bottleneck between bench~     and bedside is the paucity of available surrogate markers for HD. Identification of surrogate~     markers is critical for the design of future clinical trials. Such markers could provide a~     reliable signal of early brain dysfunction in HD and could be used as a biomarker in trials~     of agents that could prevent onset or delay progression of disease.~      Frontal-subcortical networks are known to be affected in HD and contribute to the cognitive~     dysfunction characteristic of the disease. Quantitative EEG (QEEG) can be used to assess the~     integrity of this circuitry; characteristic QEEG abnormalities long have been known to be~     present in the early stages of the illness (Bylsma et al., 1994). More recent research has~     suggested that a comprehensive topographic approach to QEEG analysis may reveal additional~     changes in brain activity (Bellotti et al., 2004) that may be indicative of subclinical~     disease (de Tommaso et al., 2003). This proposal aims to determine whether quantitative EEG~     techniques can be used to identify HD-specific abnormalities and thus serve as surrogate~     markers of disease.~      The goals of this pilot project are three-fold. First, we will determine if there are QEEG~     differences between normal control subjects and those with mild or moderate HD. Second, we~     will examine associations between severity of HD and the QEEG differences detected and~     determine if these QEEG differences are present when comparing the least affected HD subjects~     and normal controls. Third, we will examine associations between QEEG variables of interest~     and other clinical variables, including age of onset of symptoms, number of CAG repeats,~     severity of motor and behavioral symptoms as measured by the Unified Huntington Disease~     Rating Scale (UHDRS) subscores, and severity of cognitive impairment as measured by the~     cognitive subscore of the UHDRS and Mini-Mental State Examination (MMSE).~   "
220647|NCT00670696|"~     Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of~     tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute~     application time for venopuncture and a 45 minute application time for venous cannulation.~     The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in~     preventing venous cannulation related pain when applied for the recommended treatment~     durations of 30 minutes and 45 minutes respectively.~   "
220648|NCT00670683|"~     This study is conducted in Asia. This study is a prospective, open, uncontrolled,~     observational surveillance study with Levemir® FlexPen® conducted in Korea.~      The aim of this observational study is to evaluate the short term and the long term safety~     and efficacy of Levemir® FlexPen®. The study is planned and conducted as per requirement from~     Korea Food and Drug Administration (KFDA).~   "
220649|NCT00670670|"~     Influence of CPP-ACP paste on the evolution and appearance of white spot lesions in~     orthodontic patients after removal of the fixed appliances.~   "
220650|NCT00670657|"~     Patients will receive 2mg/kg/day IV daily administration of AmBisome® over 30-60 minutes as a~     reaction to signs/symptoms and positive Candida culture~   "
220651|NCT00670644|"~     RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan~     better at-home self-care treatment.~      PURPOSE: This research study is looking at self-care practices for lymphedema in patients~     with breast cancer.~   "
220652|NCT00670631|"~     The two objectives of this study are:~        -  To increase the 2-year event-free survival from 55%, established with Total Therapy II~          (UARK 98-026), to 75% in myeloma patients with cytogenetic abnormalities, and from 80%,~          established with the Total Therapy II regimen, to 95% in myeloma patients without~          cytogenetic abnormalities.~        -  To determine whether bortezomib, thalidomide, and dexamethasone can be safely~          incorporated with transplant 1 into the established pre-transplant regimen of high-dose~          melphalan (used in Total Therapy II) and whether Velcade and gemcitabine can be safely~          added to the transplant 2 high-dose chemotherapy regimen of combination melphalan and~          BCNU.~   "
254220|NCT00223548|"~     The purpose of this study is to determine wether Mesna could prevent contrast-induced~     nephropathy~   "
220656|NCT00670579|"~     Pulmonary infections are the major cause of mortality and morbidity in cystic fibrosis (CF);~     patients frequently have to take antibiotics which often cannot be given orally or by aerosol~     but have to be administered intravenously. In order to reduce the number of venepunctures,~     totally implanted venous access devices (TIVAD) or Ports have been used to administer~     antibiotics and other infusions.~      The use of Port systems has been increasing in recent years, especially for those patients~     requiring frequent intravenous treatments. Having a TIVAD in place makes venous access~     quicker and also reduces trauma, suffering and pain. However, there are important~     complications associated with TIVADs which can be early (pneumothorax, arterial puncture,~     severe bruising) or late (infections, thromboembolic complications and occlusion).~      Although the use of TIVADs in CF is increasing, there is little CF-specific literature~     available on the epidemiology and risk of TIVAD complications. Also, literature is scarce~     about clinical criteria for deciding to insert a TIVAD. Therefore, so far clinical decisions~     were based mainly on experiences of TIVAD use in other diseases, such as cancer.~      With this prospective observational study we will survey a large population of Italian CF~     people with TIVAD in order to: collect data about current clinical conditions of CF people~     with TIVAD; investigate about clinical criteria that led to the decision of positioning a~     TIVAD; observe the possible onset of late complications.~   "
220657|NCT00670566|"~     The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of~     Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive~     patients.~      The secondary objective is to get systolic blood pressure and diastolic blood pressure goal~     attainment rate from CoAprovel in Chinese hypertensive patients.~   "
220658|NCT00670553|"~     The purpose of this study is to assess the feasibility of combined administration of~     different LBH589 dosages with radiotherapy in order to establish the dosage to be evaluated~     in future studies.~   "
220659|NCT00670540|"~     The purpose of this study is to determine different risk factors of thromboembolic disease.~     Different points will be studied~        1. do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT),~          proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical~          significance (risk factors and prognosis) ?~        2. Is it necessary to obtain a detailed history of thromboembolic disease ?~        3. Do older patients have particular risk factors ?~        4. Do preventive treatments modify the level of risk factors and the clinical signs of~          thromboembolic disease ?~        5. Do predictive clinical scores have the same performance for both in and outpatients ?~        6. Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but~          no clinical thromboembolic symptoms, develop a low risk ?~        7. The evolution of the disease in patients with negative or positive Venous~          ThromboEmbolism (VTE) exploratory tests.~   "
220660|NCT00670527|"~     The objective of this trial is to assess the value of 18F-choline PET/CT for the detection of~     regional lymph node metastases from prostate cancer. In addition, the investigators want to~     evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate~     cancer.~   "
220661|NCT00670514|"~     Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking~     cessation support in a dental clinic setting.~      Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment~     intensity (HTI).~      Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183~     days).~   "
220662|NCT00670501|"~     The primary objective of this study is to demonstrate a reduction in the proportion of new~     vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment~     with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and~     vitamin D alone.~   "
220663|NCT00670488|"~     Treatment of patients with locally advanced or metastatic solid tumors who have failed~     standard therapy or no other standard therapy exists.~   "
220664|NCT00670475|"~     this is a randomized double blinded trial which is conducted to measure the efficacy of~     topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard~     piroxicam gel.~   "
220665|NCT00670462|"~     This study is a randomized clinical trial comparing state-of-the-art, standard behavior~     therapy for weight loss (SBT) with a maintenance tailored treatment (MTT) with varied~     behavioral prescriptions, goals, and formats over time. The overall hypothesis in the study~     is that the two treatment approaches will show different patterns of weight loss over time,~     and in particular that the MTT approach would be associated with better long-term maintenance~     of weight loss.~   "
220666|NCT00670449|"~     This study was an extension study of NCT00537082. This study was designed to evaluate the~     efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720)~     to relapsing multiple sclerosis.~   "
220667|NCT00670436|"~     The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting~     PTCA-balloon in combination with bare-metal stenting for treatment of chronic total~     occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.~   "
220668|NCT00670423|"~     The purpose of this study is determine the highest dose of bortezomib, a new drug for~     graft-versus host disease prevention, that can be given in combination with sirolimus and~     Tacrolimus, without causing severe side effects. This research is being done because there is~     no treatment that is 100% effective in preventing graft versus host disease.~      The goals of this study are to:~        1. Collect peripheral blood stem cells (PBSCs) from donors for transplant.~        2. Determine the largest possible dose of bortezomib that can be given to recipients with~          various blood cancers in a safe manner.~        3. Monitor the recipient for risk of infection or side affects associated with the~          transplant.~        4. Monitor the recipient for increased immunity following transplantation.~   "
220682|NCT00670241|"~     This study will compare efficacy and safety of once daily treatment of calcipotriol plus~     betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle~     alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks~     followed by an observation period of up to 8 weeks to investigate the occurence and the time~     to relapse and occurence of rebound after discontinuation of the investigational products.~     Only subjects with controlled disease will be considered for this observation phase of the~     study. Controlled disease is defined as Clear or Almost Clear severity category based~     on Investigator's global assessment (IGA).~   "
220669|NCT00670410|"~     Neuroblastoma is a malignant tumor of the sympathetic nervous system. It is the second most~     common malignant tumor of childhood. Although modest advances have been made over the past 20~     years children with high-risk neuroblastoma continue to have an unsatisfactory long-term~     survival. This study will administer induction chemotherapy followed by high-dose~     (myeloablative) chemotherapy with autologous stem cell transplantation, followed by radiation~     therapy, then immunotherapy with a non myeloablative allogeneic stem cell transplant for~     treatment of neuroblastoma. The purpose of this clinical research trial is to study the~     feasibility of giving immunotherapy with a non-myeloablative allogeneic transplant~     (NAT/AlloSCT), following myeloablative therapy and autologous stem cell transplant~     (MAT/AutoSCT). This study will also determine the side effects as well as the response rate~     for each group of patients (treatment arm).~   "
220670|NCT00670397|"~     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells.~     The drug becomes active when it is exposed to light. When the drug is active, tumor cells are~     killed.~      PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic~     therapy using HPPH in treating patients with recurrent dysplasia, carcinoma in situ, or stage~     I oral cavity cancer.~   "
220671|NCT00670384|"~     The purpose of this study is to identify an effective dose of allergen-specific immunotherapy~     for short ragweed (Ambrosia artemisiifolia) administered by an oral/sublingual route.~   "
220672|NCT00670371|"~     The objective is to find determinants for the subjective and objective burden of informal~     caregivers to patients who are requiring continued antipsychotic treatment for functional~     psychoses among factors related to the patient, the health care and support provision system~     and the informal caregiver him/her-self.~   "
220673|NCT00670358|"~     RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer~     cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving lenalidomide together with rituximab and combination chemotherapy~     may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide~     when given together with rituximab and combination chemotherapy and to see how well they work~     in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large cell~     or follicular B-cell lymphoma.~   "
220674|NCT00670345|"~     This prospective randomized double-blind placebo vs control study aims at verifying the~     efficacy of tranexamic acid administration in reducing perioperative bleeding in patients~     undergoing open radical prostatectomy. Two recent meta-analysis confirmed that tranexamic~     acid administration does not increase mortality, myocardial infarction, deep venous~     thrombosis, pulmonary embolism, stroke and renal failure.~      200 patients undergoing open radical prostatectomy will be enrolled. Patients will receive a~     slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by~     250 mg/h of tranexamic acid by continuous infusion.~      Patients belonging to the control group will receive the same volume of saline infusions.~   "
220675|NCT00670332|"~     This study will demonstrate whether patients with prognostically-significant myocardial~     abnormalities detected with AI-700 contrast ECHO have a rate of cardiac death or MI that is~     higher than that of patients with normal AI-700 contrast ECHO.~   "
220676|NCT00670319|"~     To study the effect of long-term treatment with raloxifene, compared with placebo, on the~     rate of new vertebral fractures in osteoporotic postmenopausal women with and without~     existing vertebral fractures.~   "
220677|NCT00670306|"~     Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human~     males over the age of 50 which increases in prevalence with age and 40% of males reported~     moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this~     study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate.~      For this study, study medication (Cetrorelix pamoate) is administered by injection in the~     buttocks (Intramuscular).~   "
220678|NCT00670293|"~     This study will use positron emission tomography imaging to investigate changes in dopamine~     systems in people with anorexia nervosa before and after weight restoration.~   "
220679|NCT00670280|"~     This study is about reducing the risks of smoke-related infant health problems. Research has~     shown that infants exposed to secondary smoke have higher risks of delayed lung development,~     respiratory illnesses, wheeze, cough, asthma, middle ear disease, and sudden infant death~     syndrome. Infants who have experienced low birth weight or required mechanical ventilation~     may be at an even greater risk for the negative effects of smoking. The purpose of this study~     is to evaluate the effectiveness of a 3-session program aimed at assisting the primary care~     giver in reducing risks to their child's health by decreasing infant smoke exposure in their~     home and/or reducing overall cigarette use.~      Caregivers will not be required to quit smoking to take part in this program. This~     information will, in the future, help to identify and improve ways of reducing health~     problems and perhaps death in children.~   "
220680|NCT00670267|"~     The purpose of this study is to confirm previous observations in asthmatics that chronic~     nadolol treatment reduces asthmatic airway hyper-responsiveness.~   "
220681|NCT00670254|"~     Severe sepsis is a disease with a high mortality. Development of shock is a most serious~     complication and increases the risk of death considerably. Application of low dose~     hydrocortisone is currently recommended only in patients after severe septic shock has been~     established. Hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse~     shock, however, the preventive application has not been investigated in a larger study. The~     study investigates whether low dose hydrocortisone prevents the development of shock in~     patients with severe sepsis. It is postulated that shock prevention may also affect morbidity~     and mortality.~   "
220729|NCT00669591|"~     The purpose of the study is to determine the overall response to a combination of bavituximab~     and docetaxel in patients with advanced breast cancer~   "
220769|NCT00669071|"~     This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide~     0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense~     pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a~     10 week treatment period.~   "
220683|NCT00670228|"~     Primary objective:~      To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial~     Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using~     insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in~     reducing infarct size at day 60 versus (vs) Standard Glycemic Care (SGC).~      Secondary objectives:~      To demonstrate that tight glycemic control using insulin glulisine and insulin glargine~     reduces markers of inflammation and improves Left Ventricular (LV) function and~     Cardio-Vascular (CV) outcomes from baseline values, in hyperglycemic subjects with STEMI~     undergoing Percutaneous Coronary Intervention (PCI).~   "
220684|NCT00670215|"~     The primary purpose of this clinical trial is to compare in a double-blind randomized trial,~     the efficacy and safety of ciprofloxacin MR 1000 mg tablets given as a single-dose or as a~     multiple-dose regimen for the prevention of infectious complications in patients undergoing~     transrectal needle biopsies of the prostate (TRNBP).~   "
220685|NCT00670202|"~     To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of~     vascular dysfunction in patients with atherosclerosis.~   "
220686|NCT00670189|"~     The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with~     advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule~   "
220687|NCT00670176|"~     Pre- and postoperative cardiopulmonary rehabilitation reduces complications after coronary~     artery bypass surgery. This study was conducted as a randomized trial to verify this~     hypothesis in our institution. ICSC~   "
220688|NCT00670163|"~     This study will evaluate the effectiveness of community-level behavioral and biomedical~     interventions, each alone and combined, in reducing sexual risk behavior and HIV/sexually~     transmitted infections in Peruvian men who have sex with men.~   "
220689|NCT00670150|"~     The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated~     APL will be assessed.~   "
220690|NCT00670124|"~     Treatment options in patients with high intracranial pressure due to acute liver failure are~     limited. This study intends to evaluate the effect of prophylactic hypothermia on preventing~     high intracranial pressure and compromised cerebral oxidative metabolism.~   "
220691|NCT00670111|"~     This study will look at how pacing your heart may assist your daily activities and how you~     are feeling.~   "
220692|NCT00670098|"~     The main purposes of the study are to compare changes in sexual function, changes in sex~     hormones, and changes in body image and marital satisfaction at 12, 24, 36 and 48 months~     postoperatively in two groups: individuals who undergo a bariatric surgical procedure and~     extremely obese individuals with similar obesity-related comorbidities who do not seek~     surgery (treatment comparison group).~      The mechanisms by which extreme obesity affects sexual functioning have received little~     attention. Recent epidemiologic studies suggest that obesity and physical inactivity are~     independently related to the likelihood of developing sexual dysfunction over time. For~     example, men with a BMI greater than 29 kg/m2 have a 30% greater risk of developing erectile~     dysfunction and up to 50 % of ED cases can be attributed to hypertension and cardiovascular~     disease, both commonly associated with obesity. Many treatments for hypertension have also~     been shown to interfere with sexual function.~      Changes in sex hormones with increasing BMI have not received much attention either. Obesity~     has been associated with decreases in testosterone and sex hormone binding globulin for men~     and increases in testosterone and estrogen for women. Several studies have shown improvement~     in sex hormone levels in both men and women following weight loss. Sexual functioning has~     never been assessed in association with weight loss and whether through improvements in body~     image, sex hormones, or obesity related comorbidities, bariatric surgery may have a profound~     effect on sexual functioning.~      Dr. Ray Rosen, the Principal investigator for this sub study, has conducted a previous~     investigation focused on sexual functioning after weight loss in a behavioral weight loss~     program. Specifically, he looked at short and long term sexual function outcomes associated~     with Type-2 diabetes. His previous work in this area has shown that patients are willing to~     participate in studies of sexual function.~      The Psychosocial Changes study assesses sexual function in two ways. Participants first fill~     out a packet of questionnaires covering topics related to depression, quality of life, body~     image, and marital and sexual functioning. They also give a blood sample in order for us to~     assess levels of sex hormones including testosterone, luteinizing hormone, estradiol,~     follicle stimulating hormone, and others.~   "
220693|NCT00670059|"~     BACKGROUND: Single-embryo transfer is a well-accepted strategy to avoid multiple pregnancies~     in an assisted reproductive technology programme. The selection of the embryo with the~     highest implantation potential is a crucial step. Besides the morphological quality and~     embryo kinetics up to the blastocyst stage, pre-implantation genetic screening (PGS) of~     aneuploidy has been advocated as an adjuvant approach by which to select the right embryo for~     transfer.~      METHODS: Couples with a female partner younger than 36 years were randomly assigned to~     undergo transfer of a single blastocyst in a cycle with or without PGS using fluorescence in~     situ hybridization for the chromosomes X, Y, 13, 16, 18, 21 and 22.~   "
220694|NCT00670046|"~     RATIONALE: Valproic acid may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether valproic acid is more effective than~     observation in treating patients with prostate cancer.~      PURPOSE: This randomized phase II trial is studying how well valproic acid works in treating~     patients with progressive, non-metastatic prostate cancer.~   "
220695|NCT00670033|"~     The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost~     New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or~     ocular hypertension.~   "
220696|NCT00670020|"~     The purpose of this study is to determine whether supplemental perioperative oxygen~     significantly decreases the incidence of post-Cesarean endometritis and wound infection among~     women who undergo Cesarean section after the onset of labor.~   "
220697|NCT00670007|"~     This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to~     evaluate the efficacy and safety of Zemaira® intravenous (i.v). administration in subjects~     with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a~     disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by~     volume-adjusted lung density, measured yearly by computed tomography (CT).~   "
220698|NCT00669994|"~     This trial evaluated how effective and safe Cipro XR was in treating female patients with~     signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients~     were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was~     eliminated.~   "
220699|NCT00669981|"~     This study will evaluate the effectiveness of cognitive behavioral couples therapy designed~     for post-traumatic stress disorder in reducing symptoms of post-traumatic stress disorder and~     in improving relationship functioning.~   "
220700|NCT00669968|"~     How does PET myocardial perfusion imaging involving CT angiography and measurement of~     coronary flow reserve affect patient care.~   "
238174|NCT00437905|"~     The purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon~     angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral~     artery disease.~   "
220701|NCT00669955|"~     This study aims at evaluating efficacy and safety of quadruple therapy (bismuth,~     metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin,~     clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that~     quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed~     H. pylori positive status will be randomized to one of the treatments described above. At~     week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm~     eradication.~   "
220702|NCT00669942|"~     Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a~     single dose (intravenous infusion) in patients with active rheumatoid arthritis in~     combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.~   "
220703|NCT00669929|"~     The primary objective of the proposed project is to estimate the economic impact of a~     national rotavirus immunization program in preventing rotavirus diarrhea among Korean~     children.~   "
220704|NCT00669916|"~     This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study~     comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe~     stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or~     placebo will be administered by single infusion at baseline and subjects will be observed for~     up to 26 weeks following the infusion.~   "
220705|NCT00669903|"~     This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of~     multiple ascending doses of AZD0328 in patients with schizophrenia~   "
220706|NCT00669890|"~     The addition of gemtuzumab ozogamicin (GO) in combination with Busulfan/Cyclophosphamide~     followed by AlloSCT in patients with high risk CD33+ AML/JMML/MDS will be safe and well~     tolerated.~      This study will attempt to determine the maximum tolerated dose of the immune therapy~     (gemtuzumab) when given in combination with the myeloablative (high dose) drugs used in this~     study for allogeneic stem cell transplant. (Part A)~   "
220707|NCT00669877|"~     The goal of this clinical research study is to learn if intensive chemotherapy given over 6~     months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small~     non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment~     works when given with Rituximab. The safety of the combined treatment will also be studied.~   "
220708|NCT00669864|"~     This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose~     control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese~     subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.~   "
220709|NCT00669851|"~     This study evaluated and optimized settings for, and evaluated the performance of,~     AI-700-enhanced echocardiographic imaging on several ultrasound imaging platforms, as well as~     collected additional safety data for AI-700 in healthy volunteers and stable cardiac~     patients.~   "
220710|NCT00669838|"~     Prospective, randomized double-blinded study to investigate hemodynamic changes in valvular~     cardiac patients during dental treatment with the use of a local anesthesia containing~     epinephrine.~   "
220711|NCT00669825|"~     ALV003-0812 is a study of the safety and tolerability of a study drug (ALV003) in healthy~     adult volunteers and in patients with well-controlled celiac disease, following a meal that~     contains gluten.~   "
220712|NCT00669812|"~     RATIONALE: Giving chemotherapy before a peripheral blood stem cell transplant stops the~     growth of cancer cells by stopping them from dividing or by killing them. After treatment,~     stem cells are collected from the patient's blood and stored. More chemotherapy is given to~     prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the~     patient to replace the blood-forming cells that were destroyed by the chemotherapy.~      PURPOSE: This phase II trial is studying high-dose chemotherapy given together with~     peripheral blood stem cell transplant in treating patients with intestinal T-cell lymphoma.~   "
220713|NCT00669799|"~     Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20~     million Americans suffering from this diagnosis at a cost of over $4.3 billion per year.~     Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for~     antifungal irrigation has also been proposed. Topical antibiotics are used by some~     physicians, but there are few reports in the published literature describing their use and~     establishing or refuting their efficacy.~      Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients~     using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and~     tramazoline without antimicrobial; and placebo. Both of the treatment groups showed~     improvement over placebo, but in those groups there was no significant difference in response~     rates between those patients receiving neomycin and those who did not. There were no adverse~     events reported. In the same year, Cuenant et al. reported success with neomycin-tixocortol~     irrigations in the treatment of chronic rhinosinusitis.~      Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized~     antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are~     uncontrolled, retrospective studies showing improvement in symptom scores. Neither study~     reported any major side effects. Leonard and Bolger describe a case report and review their~     success with the use of topical Ceftazidime in 50 patients. Only one patient reported~     stinging sensation during administration. They reported no problems with antibiotic~     resistance.~      Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for~     sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms and~     reduction of need for revision sinus surgery in patients treated with surgery followed by~     topical intranasal tobramycin. They report no significant side effects.~      Dudley described the use of topical gentamicin in a case report of a patient with atrophic~     rhinitis. The patient had resolution of her complaints without any adverse symptoms. He also~     describes a study by Thornell showing success with streptomycin nasal sprays and reports work~     by Rubinstein demonstrating safe administration of gentamicin into the nose without~     absorption by the nasal mucosa.~      On balance, the literature describes topical antibiotics as a safe, but variably efficacious~     treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized, blinded,~     and controlled studies. The purpose of this protocol is to describe a scientifically rigorous~     study of the use of broad spectrum antibiotic nasal sprays for chronic sinusitis.~      The patient population for this study will consist of patients who have a history of multiple~     sinus infections each year that require treatment with antibiotics. The patients in this~     study will have had recurrent infections despite prior medical and surgical intervention.~     They will fulfill the criteria for chronic rhinosinusitis without nasal polyposis.~      Treatment will include conventional treatment with oral antibiotics and a topical nasal~     steroid. In addition, patients will be randomized to receive either topical antibiotics or a~     vehicle placebo. The study will follow patients for a three month period.~      Patients will be monitored for improvement in radiographic findings and quality of life when~     compared to a randomized and double-blinded placebo group. The patient population identified~     for inclusion in this study will also be evaluated for allergy and humoral and innate~     immunodeficiency. Nasal lavage will be obtained from the study population and pre and~     post-treatment comparisons will be performed.~   "
220714|NCT00669786|"~     A randomized controlled trial comparing the ongoing pregnancy rate (primary end-point) in 280~     patients undergoing IVF/ICSI after stimulation with hp-hMG or rFSH controlled with a GnRH~     antagonist. Non significant differences were observed between hp-hMG and rFSH in terms of the~     ongoing pregnancy rate per started cycle (35.0% vs. 32.1%; p=0.61); R.R: 1.09 (95% CI:~     0.78-1.51; Risk Difference: 2.9%). No differences were observed for implantation, clinical~     pregnancy and pregnancy loss rates. Patients receiving rFSH obtained more oocytes (14.4 ± 8.1~     vs. 11.3 ± 6.0; p=0.001). Estradiol was higher at the end of stimulation in the hp-hMG group,~     while Progesterone was higher in patients stimulated with rFSH.~   "
220715|NCT00669773|"~     Primary Objectives~        1. Validate our previously generated tumor gene expression and proteomic profiles in this~          independent sample to determine the predictive power to distinguish good from poor~          clinical and pathological responders to adriamycin or docetaxel.~        2. Validate our previously generated plasma proteomic profiles in this independent sample~          to determine the predictive power to distinguish good from poor clinical and~          pathological responders to adriamycin and docetaxel.~      Secondary objectives~        1. To correlate adriamycin and docetaxel pharmacokinetics with~             1. Genetic polymorphisms of drug metabolizing enzymes and transporters, including~               MDR-1, Cyp3A, GSTs, and the nuclear receptors.~             2. Drug toxicity and tumor response.~             3. Peripheral mononuclear cell gene expression profiles~        2. To study ondansetron pharmacokinetics and correlate that with genetic polymorphisms.~   "
220725|NCT00669643|"~     The purpose of this randomized trial is to verify if leprosy patients, despite of their~     classification, can be treated with the same regimen without compromising patient cure and~     acceptability of the treatment. At present, patients classified as multibacillary leprosy are~     treated for 12 months with three drugs, and patients classified as paucibacillary leprosy are~     treated for 6 months with two drugs. The study is going to test a unified regimen for~     paucibacillary and multibacillary patients by treating leprosy patients with three drugs for~     6 doses.~   "
220726|NCT00669630|"~     This study will train Lay Health Promoters (LHPs) from African-American churches to~     administer healthy living lessons and activities to their congregations in order to improve~     overall health and address cardiovascular disease. The primary hypothesis is that LHP~     training combined with a well supported maintenance strategy will be more effective than LHP~     training alone in reducing risk factors for cardiovascular disease.~   "
220716|NCT00669760|"~     Staphylococcus aureus is not only one of the first pathogens infecting the airways of cystic~     fibrosis (CF) patients, but also a highly prevalent microorganism (>60% of all CF patients;~     European and American CF registries; (4,25), which often persists for several years in the~     respiratory tract of CF patients.~      The purpose of this study is to dissect infection by S. aureus from colonization. Therefore,~     the following non-interventional prospective, longitudinal multicenter study will be~     conducted to develop the following hypothesis:~      CF patients with high bacterial loads are more likely to be infected by S. aureus than~     patients with low bacterial loads.~      Primary endpoint: bacterial load of sputum cultures~      Secondary endpoints:~        -  nasal carriage~        -  molecular analysis of S. aureus (Monoclonal/polyclonal)~        -  serum: S. aureus-specific antibodies, S100A12, IL-8, TNF-alpha~        -  sputum: S100A12, IL-8, myeloperoxidase~        -  S. aureus therapy regimens~        -  lung function tests: FEV1, deltaFVC , deltaMEF25~        -  BMI development~      Inclusion criteria: S. aureus cultures for more than 6 months within the last year, children~     (>6 years) and patients, who are able to perform lung function tests Exclusion criteria: P.~     aeruginosa and/or B. cepacia cultures from the specimens for more than 6 months within the~     last year before recruitment or during the study period In addition to microbiological~     investigations and clinical laboratory tests, the actual clinical situation will be evaluated~     and reported during the study period. The results of this observational study will be used to~     carefully plan a clinical interventional study. Furthermore, with the results it might be~     possible to characterize a subpopulation of patients, which is at greater risk for S. aureus~     infections.~   "
220717|NCT00669747|"~     The primary objective of this study is to compare the safety of 100 mg carboplatin~     administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal~     carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15~     intraductal infusion. Secondary objectives are to characterize the biologic and clinical~     effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram,~     histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.~   "
220718|NCT00669734|"~     This phase I trial studies the side effects and best dose of vaccine therapy when given~     together with sargramostim in treating patients with locally advanced or metastatic~     pancreatic cancer that cannot be removed by surgery. Vaccines made from a gene-modified virus~     may help the body build an effective immune response to kill tumor cells. Colony-stimulating~     factors, such as sargramostim, may increase the number of immune cells found in bone marrow~     or peripheral blood. Giving vaccine therapy directly into the tumor together with~     sargramostim may cause a stronger immune response and kill more tumor cells.~   "
220719|NCT00669721|"~     A randomised, prospective, cross over study will be done to determine whether the~     anticoagulation therapy with UFH or LMWH used for hemodialysis sessions modifies~     osteoprotegerin and RANKL plasma levels.~   "
220720|NCT00669708|"~     Dry skin is a physiological condition and is characterized in contrast to greasy skin by~     roughness, desquamation and lack of brightness of the skin surface. Subjectively, feelings of~     tension, burning and itching can occur. The skin reacts more intensive on external and~     physical noxae. Dry skin is caused by a lack of moisture. This is most common during the~     winter months, when heating systems dry the air. Bathing with hot water, spending extended~     periods of time in the hot sun, and the skin's natural aging process also remove moisture and~     oils from the skin. It is diagnosed through clinical observation. People suffering from dry~     skin often desire to improve this condition for optical cosmetic reasons and due to the~     occasional feeling of tension. The aim of this investigation is to observe the improvement~     (or not) of dry itchy skin by a lotion containing a cooling compound~   "
220721|NCT00669695|"~     The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial~     function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of~     treatment, by a double-blind, randomized, placebo-controlled, multi-center study.~      An interim analysis will be performed when 25 patients per group will be included.~   "
220722|NCT00669682|"~     T-wave alternans is a test that is currently being used to risk stratify patients with~     structural heart disease for sudden cardiac death. The mechanism of T-wave alternans is~     unclear, but may share a common abnormality with conditions of cardiac fluid overload such as~     heart failure, which is altered intracellular calcium handling. Current Medtronic implantable~     defibrillators have the capability of monitoring cardiac fluid status via transthoracic~     impedance measurements.~      The purpose of this study is to determine if a correlation exists between T-wave alternans~     status and cardiac volume status, as determined by transthoracic impedance measurements.~     Secondarily, the study seeks to examine the relationship between arrhythmia frequency and~     T-wave alternans or cardiac volume status.~   "
220723|NCT00669669|"~     This phase I/II trial studies the side effects and best dose of temozolomide when given~     together with radiation therapy, carmustine, O6-benzylguanine, and patients' own stem cell~     (autologous) transplant in treating patients with newly diagnosed glioblastoma multiforme or~     gliosarcoma. Giving chemotherapy, such as temozolomide, carmustine, and O6-benzylguanine, and~     radiation therapy before a peripheral stem cell transplant stops the growth of cancer cells~     by stopping them from dividing or killing them. Giving colony-stimulating factors, such as~     filgrastim or plerixafor, and certain chemotherapy drugs, helps stem cells move from the bone~     marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is~     then given to prepare the bone marrow for the stem cell transplant. The stem cells are then~     returned to the patient to replace the blood-forming cells that were destroyed by the~     chemotherapy and radiation therapy.~   "
220724|NCT00669656|"~     This study is about Prostate Health Cocktail, a combination supplement that contains vitamin~     D3, vitamin E, selenium, green tea extract, saw palmetto, lycopene, and soy derivatives. This~     product is currently available on the market, as herb and vitamin supplements are not~     regulated by the FDA. Each ingredient has been studied in prostate cancer cells and/or in~     patients with prostate cancer. At the doses included in this supplement, no serious side~     effects have been reported.~      The purpose of this study is to find out whether Prostate Health Cocktail can lower your PSA.~     Additionally, we will be looking to see whether taking this treatment causes any unexpected~     side effects, and whether certain blood tests can inform us about your disease status in~     addition to your PSA~   "
220727|NCT00669617|"~     This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to~     placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg~   "
220730|NCT00669578|"~     RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in~     different ways and stop cancer cells from growing. CC-4047 may also stop the growth of cancer~     cells by blocking blood flow to the cancer.~      PURPOSE: This trial is studying the side effects and best dose of CC-4047 and to see how well~     it works in treating patients with myelofibrosis.~   "
220731|NCT00669565|"~     This is a phase II, multicenter, single-arm, open-label safety and efficacy study of~     bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced~     or metastatic breast cancer.~   "
220732|NCT00669552|"~     T-wave alternans is a test that looks at microvolt changes in the T-wave on a beat to beat~     basis. The presence or absence of such changes has been shown to predict or exclude future~     arrhythmic events. The mechanism of T-wave alternans is unclear, but may relate to calcium~     metabolism in the heart, and may be affected by conditions such as ischemia or heart failure.~      The purpose of this study is to determine whether T-wave alternans, as measured through the~     lead of an implantable defibrillator, is produced by acute ischemia induced by occlusion~     during percutaneous coronary interventions.~   "
220733|NCT00669539|"~     This study will evaluate the effectiveness of refractive correction alone for the treatment~     of previously untreated strabismic or combined-mechanism amblyopia in children 3 to <7 years~     old with visual acuity of 20/40 to 20/400~   "
220734|NCT00669526|"~     This project assesses the clinical and cost effectiveness of brief cognitive-behavioral~     therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in~     pediatric primary care. This study is designed to compare the impact of brief CBT delivered~     on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well~     as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and~     the cost-effectiveness of the protocols compared to referral to and utilization of SMHC~     services.~   "
220735|NCT00669513|"~     Background: Sleep curtailment is common and is associated with increased mortality due to~     cardiovascular causes. However, the mechanisms are not completely understood.We hypothesized~     that partial sleep deprivation caused however significant changes in sympathetic activity and~     endothelial function in healthy volunteers.~      Methods: Thirteen young healthy male volunteers will be monitored during 12 days by sleep~     diary and wrist actigraphy. The subjects will keep under their usual daily activities and~     randomized to 5 nights of prolonged sleep (control) or partial sleep deprivation, interposed~     by 2 nights of unrestricted sleep (wash out). At the end of each period, the subjects will be~     evaluate by: 1. electrocardiogram and beat-to-beat blood pressure with spectral analysis of~     heart rate and blood pressure in the supine position and after head up tilt test maneuver; 2.~     resting plasma norepinephrine; 3. venous endothelial function (dorsal hand vein technique).~   "
220736|NCT00669500|"~     Primary Aim # 1: Determine the willingness of the public to participate in an intervention~     trial - NutritionQuest's Alive!TM - available in a public forum.~      Aim #1 Hypotheses: Less than 10% of individuals visiting the NutritionWeek site will register~     to participate in the Alive!TM Intervention; 70% of these individuals will complete the full~     intervention.~      Primary Aim # 2: To determine among individuals enrolled in the Alive!TM intervention,~     changes in measurements of body composition from pre- to post-intervention.~      Aim #2 Hypotheses: Participation in Alive!TM will result in positive changes in body~     composition, including reduction of body weight, percent body fat and blood LDL and an~     increase in blood HDL cholesterol.~      Purposes:~        1. Educate the public on the relationship between diet, weight and chronic disease~        2. Collect data for future research~        3. For participants of the Oregon Museum of Science and Industry (OMSI) portion of this~          study, we also provide a diet assessment and optional 3-month intervention~      Recruitment:~      Researchers will have a display at OMSI coincidental with the Body Worlds 3 exhibit and at~     local health fairs. Participants will be recruited from the attendees of the OMSI Body Worlds~     3 exhibit as well as general OMSI visitors from July through October 2007 and from health~     fairs at later dates.~      Subject procedures:~      No identifiable information will be collected; only gender, year of birth, race and ethnicity~     are collected on any participant.~      Subjects under age 18 can participate in any or all of the following: a brief online,~     touch-screen assessment of eating and physical activity (health screening for immediate,~     printed feedback), physiologic measurements (height, weight, hip and waist circumference,~     percent body fat, blood pressure).~      Subjects who are age 18 and over can participate in any or all of the following: a brief~     online, touch-screen assessment of eating and physical activity (health screening for~     immediate, printed feedback), physiologic measurements (height, weight, hip and waist~     circumference, percent body fat, blood pressure), finger prick to assess blood glucose and~     lipid levels as well as DNA sample (mouthwash swish).~      For participants of the OMSI portion of this study, adults may also choose to join a 3-month~     online lifestyle intervention (Alive!™). Participants who enroll in the 3-month intervention~     will receive 12 intervention messages over a 3-month period. Each of the messages will take~     about 5 to 10 minutes to read. At the end of this 3-month period, participants will receive a~     post-assessment health screening at the Oregon Health & Science University (OHSU) Clinical~     and Translational Research Center. This post-assessment will include completion of a diet and~     physical activity assessment, fasting blood measures of glucose and lipids, blood pressure,~     weight and height.~      All visitors to the display area and all research subjects will be offered educational~     materials.~      Instruments used, for OMSI participants only:~      The Alive!TM lifestyle intervention is a web-based diet assessment program designed to help~     individuals evaluate their diet and make healthy changes via tailored e-mail correspondence.~     This program is operated by NutritionQuest out of Berkeley, California; utilizing the Block~     questionnaires, designed and validated over many years by Dr. Gladys Block, and now in use by~     researchers and health practitioners world-wide.~      Data analysis:~      De-identified data will be stored for future analyses and will be used in descriptive~     analyses to provide information on the distribution of body size variables and how they~     relate to reported dietary intake. DNA data from cheek cell samples will be linked by~     identification number to dietary intake and physiologic measures. Though de-identified, this~     data may still be used to identify genetic profiles of individuals with various physiologic~     parameters.~      For OMSI participants only:~      Alive!TM lifestyle intervention data will be used to determine predictors of change in~     physiologic and reported intake measures pre and post-intervention, using analysis of~     variance. At the time of analyses ALL data (including Alive!TM participant data) will be~     de-identified.~   "
220737|NCT00669487|"~     This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a~     regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in~     with GPO-VIR S followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will~     be anemia, neuropathy, lipoatrophy and renal function.~   "
220738|NCT00669474|"~     Part 1: patients with essential hyperhidrosis are treated one time with suction curettage in~     both axillae.~      Part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in~     one axilla, and at the same time one treatment with BOTOX injections in the other axilla.~   "
220739|NCT00669461|"~     Delayed colonic transient time secondary to a multi-degenerative process is the most likely~     cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to~     accelerate colonic transit time in healthy volunteers in addition to activating the chloride~     channels in the intestinal cells, it has the potential to improve constipation in patients~     with PD with no subsequent adverse events on the control of the neurological manifestation of~     PD. So we hypothesize the following:~        1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients~          with PD induced constipation compared to baseline.(primary)~        2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week,~          compared to baseline. (secondary)~        3. Lubiprostone will improve health related quality of life in subjects with PD induced~          constipation. ( secondary)~   "
220740|NCT00669448|"~     OBJECTIVES~      The objective is to evaluate the effect of an 8-week mindfulness-based cognitive therapy~     (MBCT) programme on psychological - and somatic symptoms, and illness perceptions in~     individuals with self- reported multiple chemical sensitivities.~      PARTICIPANTS~      Participants will be recruited among respondents to a survey on the consequences of~     self-reported symptoms related to inhalation of airborne chemicals conducted by the Danish~     Research Centre for Chemical Sensitivities.~      DESIGN~      The pilot trial is designed as a randomized trial on the effect of MBCT versus treatment as~     usual.~      INTERVENTION~      The MBCT programme includes 2½ hours of group training at the Psychiatric Centre,~     Rigshospitalet once a week for 8 weeks. Furthermore participants are encouraged to practice~     at home for up to 45 min per day, 6 days a week during the entire course.~      OUTCOME MEASURES~      Effect of MBCT will be estimated from individual scores on psychometric scales~   "
220741|NCT00669435|"~     Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes~     secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin,~     resistin and adiponectin; these proteins have a wide range of biological effects and are~     associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin~     II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or~     obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker~     (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the~     antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be~     added to both groups. The aim of this study is to evaluate the effect of losartan and~     simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or~     obese hypertensive normocholesterolemic patients with hepatic steatosis.~   "
220742|NCT00669422|"~     This study will collect patient demographic, oncology history, and physician reported outcome~     information following the initial round of chemotherapy received after a commercial ChemoFx®~     Final Report for the generation of hypotheses of potential patient cohorts for further~     sub-studies.~   "
220743|NCT00669409|"~     To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese~     patients with moderate to severe pain from OA of the knee (Part I). To evaluate the~     preliminary analgesic efficacy of PF-04383119 in Japanese patients with moderate to severe~     pain from OA of the knee in comparison with placebo (Part I and Part II).~   "
220744|NCT00669396|"~     The purpose of this study is to see if women presenting for emergency contraception (EC) are~     willing to accept the copper intrauterine device (IUD). This study will also compare the use~     of effective methods of contraception between women who selected the copper IUD or Plan B 6~     months after they received EC.~   "
220745|NCT00669383|"~     One course of steroids given to a mother before a premature delivery helps the lungs of the~     premature infant and decreases breathing problems. One course of antenatal steroids is the~     standard of care for threatened premature deliveries. It is unclear as to how long the~     benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if~     the steroids are given at least 24 hours before but within 7 days of a premature delivery. It~     is difficult to predict the timing of a preterm delivery so deliveries often do not occur~     within this time period. We hypothesize that the benefits of the steroids to the lungs wear~     off if the steroids are given more than 14 days before a preterm delivery, and that in these~     circumstances an extra course of steroids will help the premature baby's lungs and the~     premature baby will have less breathing problems as shown by lung function testing.~   "
220746|NCT00669370|"~     To determine the quality of life in patients with gastric cancer who receive combination~     treatment with docetaxel and capecitabine. Secondary endpoints are time to progression,~     overall response rate and overall survival.~      Study treatment will continue until disease progression or unacceptable toxicity.~   "
220747|NCT00669357|"~     Abiocor is a post market approval study for an Implantable Replacement Heart. This post~     approval study is currently on hold.~   "
220748|NCT00669344|"~     The study is a 24-week prospective, double blind, randomized, placebo-controlled pilot study~     of 9 mg / day Rivastigmine in patients with Vascular Cognitive Impairment Not Dementia (CIND)~     to evaluate efficacy, safety and tolerability in Asian patients. The hypothesis is that~     patients receiving Rivastigmine would improve in executive functioning domains.~   "
220749|NCT00669331|"~     No gold standard therapy exists for clearing mucus from the airways of patients with~     bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it~     failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF~     bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF~     bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline~     has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be~     examined as a long term treatment option in bronchiectasis.~      The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with~     inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with~     inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration;~     improvement in quality of life and respiratory symptoms in patients with bronchiectasis and~     pulmonary function in cystic fibrosis. The results of this current study in combination with~     a recently completed 3 month study seek to confirm these early findings and to extend the~     evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.~      We hypothesize that mannitol will improve the overall health and hygiene of the lung through~     regular and effective clearing of the mucus load. As a consequence of the reduction in mucus~     load and inflammatory process, the frequency of bronchiectasis related pulmonary~     exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in~     hospital and community health care costs are expected to change in line with improvements in~     respiratory health.~      Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52~     week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against~     control.~   "
220750|NCT00669318|"~     RATIONALE: Drugs used in chemotherapy, such as pentostatin, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Giving pentostatin~     together with alemtuzumab and rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving pentostatin together with~     alemtuzumab and rituximab works in treating patients with relapsed or refractory chronic~     lymphocytic leukemia or small lymphocytic lymphoma.~   "
220751|NCT00669305|"~     Human participants affected with sickle cell disease or thalassemia will donate bone marrow~     for use in experimental laboratory models to study potential new treatments. This is an~     observational study using bone marrow from human participants. The investigators will use~     sickle cell and thalassemia mouse models to observe and evaluate the possibility of~     correcting these disorders through genetic alterations or drug treatment.~   "
220752|NCT00669292|"~     This is a single institution phase I / II trial to evaluate the safety and efficacy of~     URLC10-177 and TTK-567 emulsified with Montanide ISA 51 in combination with different doses~     of CpG7909 in patients with advanced or recurrent esophageal cancer.~   "
220753|NCT00669279|"~     The purpose of this research study is to determine whether atenolol or controlled release~     carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure~     measured in the aorta, a large blood vessel carrying blood away from the heart, may be a~     better measure of the harmful effects of high blood pressure on the body's organs. In the~     past, blood pressure has only been measured in the arms. However, blood pressure in the arms~     may not accurately reflect the blood pressure in the aorta and thus may mislead doctors~     treating high blood pressure. For this reason, we are testing whether two different~     medications for blood pressure, both in a class called beta blockers, have similar effects on~     blood pressure in the arm and aorta.~   "
220754|NCT00669266|"~     The pathogenesis of adrenal tumors is still not fully elucidated and the treatment options~     for malignant tumors are poor. The current study investigates different aspects of the~     pathogenesis of adrenal tumors and evaluates different therapeutic options in patients with~     adrenocortical carcinoma.~   "
220755|NCT00669253|"~     Conventional non-surgical periodontal treatment, that is, root debridement using manual and~     ultrasonic means at baseline and surgery using the same means after 6 months in case of~     persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline~     and surgery using the same laser after 6 months in case of persistent deep pockets (Group 2)/~     Surgery at baseline using manual and ultrasonic means (Group 3). All patients will undergo~     supragingival maintenance on a yearly basis.~   "
220756|NCT00669240|"~     The purpose of this study is to determine the safety and efficacy of varenicline in the~     real-world environment of smokers attending primary care in routine clinical practice with~     the addition of being offered behavioral support Life REWARDSTM. This is a~     non-interventional study.~   "
220757|NCT00669227|"~     Autologous stem cells may improve myocardial regeneration after intracoronary administration~     in patients with acute myocardial infarction. The primary hypothesis of this prospective,~     placebo-controlled, double-blind trial is that the increase of ejection fraction determined~     by magnetic resonance imaging between baseline and 6 months follow-up is superior in active~     treated patients compared to patients receiving placebo. The study includes an integrated~     pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by~     cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size~     will be calculated. The primary endpoint is the improvement in left ventricular ejection~     fraction with an assumed 2.5% higher improvement in the cell treated population compared to~     the placebo treated group.~   "
220758|NCT00669214|"~     This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate~     the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and~     older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had~     no previous exposure to efalizumab. The study consisted of a screening period, a double-blind~     treatment period, an open-label treatment period, and an observation/follow-up period. The~     study enrolled 100 patients. 11 patients were excluded from all analyses because of data~     issues.~   "
220759|NCT00669201|"~     Purpose:Evaluate the feasibility of T2 cartilage mapping on MRI of the wrist and correlate~     with T2 mapping of knee cartilage.~      Study protocol: Phase 1. 10 healthy volunteers, Phase 2. 10 volunteers with osteoarthritis of~     the wrist, Phase 3. 50 patients for studies for routine MR of the wrist.~      MRI protocol: 3 T unit((Signa EXITE HDx),T1, T2 and T2 mapping sequences on axial and coronal~     orientation.~   "
220760|NCT00669188|"~     This study will investigate factors surrounding use and application of scientific literature~     in patient-provider interactions and will examine facets of the patient-provider interaction~     itself as studied in a virtual encounter using virtual reality.~      Healthy third- or fourth-year medical students or first-year medical interns in internal~     medicine and family practice specialties may be eligible for this study. Participants are~     recruited from the Washington, D.C., area.~      Study subjects perform two tasks and complete two sets of questions. The first task involves~     reading scientific content on a health topic of public interest and explaining the article as~     if to a patient. The second task involves interacting with a virtual patient in a virtual~     environment clinical scenario. While in the virtual environment, the subject wears a~     head-mounted video unit that allows him or her to see elements of the environment. The~     activities in the virtual environment take about 15 minutes. The total time for the study is~     about 60 minutes.~   "
220761|NCT00669175|"~     When narcotic pain medicine, like fentanyl or morphine, is given to adults and children for~     several days, they often develop a tolerance to the medicine. This means they may need higher~     doses over time to get the same amount of pain control. When it is time to stop the medicine,~     the dose has to be decreased slowly so that the patient does not have withdrawal symptoms.~      Naloxone is a medicine that at high doses can reverse the effects of narcotics. At very small~     doses it may help prevent tolerance and lessen the severity of withdrawal symptoms. This~     could mean less narcotic pain medicine is needed over fewer days.~      The purpose of this research study is to see if giving naloxone to neonates who require~     narcotic infusions is safe and effective. Safety will be measured by the incidence of side~     effects. Efficacy will be measured by monitoring for changes in pain and sedation scores and~     need for more pain medicine.~   "
220762|NCT00669162|"~     Following a radical prostatectomy and lymph node sampling, eligible patients will undergo~     post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal~     therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3~     months for 2 times).~   "
220763|NCT00669149|"~     The purpose of this study is to determine whether adjunction of intravenous anticoagulant~     therapy (enoxaparin, HNF, bivalirudin) to antiaggregation with clopidogrel and aspirin~     improves in-hospital results of percutaneous transluminal coronary angioplasty (ptca) in~     selected patients.~   "
220764|NCT00669136|"~     To evaluate the safety, toxicity and immunological effects of adjuvant administration of an~     experimental therapy consisting on priming with three intramuscular administrations of a~     plasmid expressing human AFP (phAFP) together with a plasmid expressing human GM-CSF~     (phGM-CSF), followed by a single intramuscular boost with an AFP adenoviral vector (AdVhAFP)~     to patients with locoregionally pre-treated hepatocellular carcinoma (HCC).~   "
220765|NCT00669123|"~     The purpouse of this study is to determine the efficacy and safety of chondroitin sulphate~     conventional treatment in patients with both knee osteoarthritis and plaque psoriasis.~   "
220766|NCT00669110|"~     The primary purpose of this study is to evaluate the long-term safety and tolerability of~     Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with~     major depressive disorder. A secondary aim is to evaluate the efficacy of DVS SR in the~     treatment of child and adolescent outpatients with major depressive disorder in an~     exploratory manner.~   "
220767|NCT00669097|"~     This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of~     TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg~     dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients)~     will receive 400mg TKI258.~   "
220768|NCT00669084|"~     This study, sponsored by NIAID and the University of Bamako, Mali, will identify genetic and~     other factors that may protect against severe malaria in some children.~      Children between 6 months and 17 years of age who live in Kenieroba, Fourda or Bozokin~     villages in Mali may enroll in the study. Participants have a blood sample collected by~     finger prick with a small needle. The blood is examined for gene variants that influence the~     severity of disease in children exposed to the malaria parasite.~      Children who develop a fever or other symptoms of malaria are evaluated and treated in~     Kenieroba s health center for up to 5 years from entering the study, or until they reach 18~     years of age. The children are treated with artesunate and amodiaquine. Children with severe~     disease are treated with quinine. One tablespoon of blood is drawn from the children for~     study.~      At the end of the dry season and the wet season, a subset of 200 healthy children are asked~     to provide 1 or 2 tablespoons of blood, drawn through a needle placed in a vein in the arm.~     Additional research blood samples may be requested from children between 2 and 17 years old.~     Blood will not be taken from any child more than twice a year.~   "
220771|NCT00669045|"~     The POST study comprised patients whose data were entered into the NRMI 4 and 5 databases.~     NRMI is a prospective, observational study of patients presenting with AMI in the United~     States. NRMI was launched in 1990 and to date has enrolled more than 2.5 million AMI~     patients. More than 1,700 hospitals have participated in NRMI during the last 16 years. The~     NRMI 4 and 5 substudies were sponsored by Genentech and collected data on approximately~     160,000 AMI patients (both ST elevation and non-ST-elevation MI) hospitalized in the United~     States each year. This corresponds to approximately 18% of the AMI patients in the United~     States.~   "
220772|NCT00669032|"~     The main objective is the long-term comparison (3 years and 4 months) of the efficacy and~     safety of repeated intra-articular administration of hyaluronic acid in the treatment of~     osteoarthritis of the knee.~   "
220773|NCT00669019|"~     This phase II trial is studying how well saracatinib works in treating patients with stage~     III or stage IV melanoma that cannot be removed by surgery. Saracatinib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth~   "
220774|NCT00669006|"~     To establish the infrastructure for a national neuropathic pain database.~      To determine the longterm outcome of the management of chronic neuropathic pain including~     pain relief, disability, and quality of life.~   "
220775|NCT00668993|"~     This pilot study will examine one issue only in weight loss - food cravings in overweight~     (i.e. BMI between 25-29.9) or obese (BMI greater than 30) consumers. Food craving is~     hypothesized to be an important intervening causal variable and the development of obesity.~      This randomized clinical trial will explore whether a relatively under researched energy~     based therapeutic procedure, Emotional Freedom Techniques (EFT), can reduce food cravings in~     participants under laboratory-controlled conditions, and compare this to a waitlist group.~     The following foods will be tested: chocolate, salty foods (e.g. chips, crisps, salted nuts),~     sweet carbohydrate foods (eg. cakes, biscuits, soft/soda drinks), carbohydrate foods which~     are neither sweet nor salty such as white refined foods such as bread), and caffeinated~     items.~      Research examining energy based procedures (e.g. EFT) combines cognitive strategies with~     somatic procedures adapted from acupuncture and related systems for altering the cognitive,~     behavioural, and neurochemical foundations of psychological problems. It is often referred to~     as psychological acupuncture. Few adequately controlled studies have been conducted on EFT~     however acupuncture has been quite extensively studied, with hundreds of research reports~     published (see attached references).~      Screening will occur over the telephone with one of the chosen self report questionnaires -~     the Food Craving Inventory (FCI; White et al., 2002). The FCI is a reliable and valid measure~     for the assessment of cravings for specific types of foods: High Fats, Sweets,~     Carbohydrates/Starches, and Fast Food Fats, all of which comprise the higher order construct~     of food craving or the FCI Total score (White et al., 2002). Higher numbers for each of the~     subscales reflect greater cravings for that food type with the highest score being 185.~     Scores of 93 or higher during the screen will be used to admit subjects to the next~     diagnostic interview phase of the trial. In addition, subjects will be asked their weight and~     height in order to ascertain their BMI and this will be confirmed in the diagnostic interview~     with a standardized weight machine.~      The Structured Clinical Interview (SCID-II; Spitzer, Williams, Gibbon, & First, 1990) has 12~     groups of questions corresponding to12 personality disorders and will be used as a diagnostic~     tool in a face-to-face interview with subjects who are suitable from the telephone screen.~     The aim is to exclude any active diagnoses from the DSM-IV in order to obtain the purest non~     clinic sample possible. All subjects will be notified by letter of the outcome of their~     diagnostic interview and those unsuitable for the trial will be told they did not meet~     selection criteria. Suitable practitioners who would be able to provide individual support~     for the food cravings will be provided in written format. Subjects who meet a diagnostic~     category will be informed of this and appropriate referral will be offered.~      Participants will be randomly assigned (using the NHMRC Clinical Trials Centre service) to a~     free group EFT treatment condition or a non treatment waitlist control condition of the same~     duration (4 weeks). This design ensures that potential treatment gains are neither due to the~     mere passage of time nor regression to the mean. To limit attrition from waitlist conditions,~     several contacts will be made with the waiting clients. Prescheduled phone contacts, for~     example, may maintain adherence to the waitlist condition.~      Prior to treatment all subjects will be weighed and height measured for their BMI status and~     food craving outcome measures (pre, post and follow-up) will be measured using:~        1. SUDS rating (subjective) in daily food diaries (food diaries were chosen as a method~          that best measures real-life eating behaviour)~        2. Power of Food Scale (Didie, 2003)~        3. Food Craving Inventory (White et al., 2002)~      Three aspects of eating behaviour will be measured using the Revised Restraint Scale (Herman~     & Polivy, 1980). The items are summed for a total score that ranges from 0 to 40. High scores~     indicate chronic dieting in which the individual is constantly cycling on and off the diet,~     typically without any substantial weight loss. Dietary restraint appears to play a causal~     role in the development of eating disorders and obesity and loss of control over intake. Food~     cravings may trigger these eating behaviours.~      The Symptom Assessment 45 (SA-45, Strategic Advantage, 1998) will be used to assess~     symptomatology across nine psychiatric domains and as measures of the outcome of the~     psychological intervention.~      Demographic information will be collected in questionnaire format at the beginning of the~     study.~      The EFT intervention will consist of 4 sessions (2 hours duration) with homework and will be~     based on standard delivery of EFT, as per founder Gary Craig's training for level 1 EFT~     certification ( see http://www.emofree.com/WorkShop/workshop-guidelines.htm#Level%201).~   "
220776|NCT00668980|"~     The aim of this study is to characterize the process of constitution of symbolic~     representation in infants with Down syndrome, as well as to investigate the relationship~     between gestures and the emergence of oral language. The investigators hypothesis is that~     children with Down syndrome could present difficulties during the constitution of symbolic~     representation that may be related to later deficits on expressive language, generally~     observed in these children.~   "
220777|NCT00668967|"~     The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil~     formulations~   "
220778|NCT00668954|"~     This is a research study designed to look at how pomegranate juice (or a placebo juice)~     affects the body through the measurement of specific biomarkers, which are indicators of~     health.~   "
220779|NCT00668941|"~     Osteoporosis is a disease that affects millions of individuals in the United States and~     abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study~     will compare continuous versus cyclic treatment with teriparatide combined with alendronate,~     another drug for osteoporosis, or teriparatide alone in women with osteoporosis.~   "
220780|NCT00668928|"~     A large and growing segment of the population is prediabetic. Dietary interventions that~     improve insulin sensitivity may be important in preventing the progression to full-blown~     diabetes in these individuals. Foods and dietary compounds that increase insulin sensitivity~     are likely to help maintain a healthier body composition. This pilot study will provide data~     to evaluate the role of dietary plant polyphenols in improving insulin sensitivity.~   "
220781|NCT00668915|"~     Total joint arthroplasty are common operations among the elderly population. The~     postoperative patients' rehabilitation process may be influenced by a variety of factors,~     such as age, BMI, perioperative hemoglobin levels, pain perception, comorbidities, etc.~     Nevertheless, only a few well controlled studies evaluated the effect of various factors on~     patients' rehabilitation short-term outcome. Furthermore, no scale has been developed, that~     can predict patients' rehabilitation and functioning levels 6 weeks postoperatively. In the~     current study we wish to evaluate the effect on patients' function that the following factors~     have: age, BMI, admission and discharge hemoglobin levels, pain perception, type of operation~     (TKA versus THA), intensity of postoperative physiotherapy, involvement of other joints by~     the primary pathology, comorbidities, and self assessed health status.~      In order to quantify patients' level of functioning, several tests will be used: hand grip~     strength, Timed up and go test (TUG) and Oxford knee and hip score. The factors that will be~     found statistically significantly associated with level of functioning, will be used in an~     attempt to develop a scale that will predict the level of functioning 6 weeks~     postoperatively.~      Such a scale can allow preoperative identification of patients at high risk of postoperative~     low functioning levels and the application of a unique rehabilitation program, for only these~     patients, in order to optimize their functioning.~   "
220782|NCT00668902|"~     The purpose of this study is to determine the function of an enzyme that breaks down drugs~     and helps the removal of drugs from your body. This enzyme is called cytochrome P450 2C19 and~     is located in your liver. Exposure to other medications or variations in genes that you have~     inherited from your parents, may speed up or slow the function of this enzyme. As a result,~     some patients may develop unwanted effects from a drug while some other patients may not get~     benefit from taking the same drug. The aim of this study is to determine the function of this~     enzyme in your liver. We will do this by performing a series of breath tests and blood~     samples after you take pantoprazole. Pantoprazole is approved as an oral and intravenous drug~     by the Food and Drug Administration (FDA).~   "
220783|NCT00668889|"~     The purpose of this study is to prove the absence of photo irritation and photo sensitivity~     potential of the product Dermacyd Tina Gel Tangerina Mix.~   "
220784|NCT00668876|"~     The purpose of this study is to determine whether immunonutrition is effective on surgical~     site infection and Th1/Th2/Th17 differentiation in patients undergoing~     pancreaticoduodenectomy~   "
220785|NCT00668863|"~     To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan,~     5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients~   "
220786|NCT00668850|"~     To compare the efficacy of Generex Oral-lyn™ RapidMist™ System and standard regular human~     insulin therapy as measured by HbA1c, in type-1 diabetes mellitus subjects on BID NPH~     intermediate acting insulin therapy.~   "
220787|NCT00668837|"~     Open-Label Extension to the double-blind effectiveness and safety study R076477-SCH-305 to~     evaluate long-term safety and tolerability in patients with schizophrenia.~   "
220849|NCT00668031|"~     The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during~     surgery, is safe and can help reduce the amount of bleeding and the need for a blood~     transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for~     significant blood loss. Because of this, there is a need for drugs that will help slow the~     amount of bleeding during surgery.~   "
220850|NCT00668018|"~     Assess efficacy of vardenafil within 6 hours after intake~   "
220788|NCT00668824|"~     Magnetic Resonance Imaging (MRI) is an effective and radiation free method of diagnosing~     Congenital Heart Disease (CHD). MRI works by taking images of the anatomy and physiology.~     These images also provide information on the hearts function and blood flow. The clarity of~     these images is enhanced by the use of contrast agents (dyes). However these agents only stay~     in the blood vessels for a short time and therefore limit the time in which the better~     quality images can be obtained. This study aims to determine whether MRI using Vasovist (a~     dye that stays in the vessels for a prolonged period of time) can improve the diagnosis of~     Congenital Heart Disease (CHD) by allowing more areas to be imaged and the improved~     assessment of various parameters (anatomy, volumes, flow) as well as vastly improving image~     quality.~   "
220789|NCT00668811|"~     This study is comparing a drug called Sutent with standard of care treatment for people with~     advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and~     effective treatment options are limited, new therapies are desperately needed.~      This study is designed to see if Sutent following therapy with radioactive iodine will target~     cancer cells and delay disease progression better than standard therapy alone. Newly~     diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard~     care are possible candidates. By entering into this study, participants agree to take oral~     Sutent for approximately two years after completing standard therapy. During this time, study~     participants will be followed closely by their doctor.~   "
220790|NCT00668798|"~     Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast~     milk is a mode of transmission~   "
220791|NCT00668785|"~     This is a randomized, open-label Phase II study evaluating the safety and efficacy of~     intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic~     Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.~   "
220792|NCT00668772|"~     The primary objectives of this study are to assess bronchodilator efficacy as determined by~     FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as~     determined bt the SGRQ and the effect on COPD exacerbations~   "
220793|NCT00668759|"~     The primary objective of the study is to demonstrate the superiority of vernakalant injection~     over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR)~     within 90 minutes of the start of drug administration. The secondary objective is to compare~     the safety of vernakalant to amiodarone.~   "
220794|NCT00668746|"~     This study will look at the safety of using the study medicine for a long time. It will see~     if the germs get used to the medicine, making it not work as well, if it's used by people~     with gum disease for a long time.~   "
220795|NCT00668733|"~     The objective of this study was to obtain long-term sustained clearance rates for subjects~     previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and~     GW01-0705.~   "
220796|NCT00668720|"~     Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is~     registration of sound in the absence of an external or internal acoustic stimulus. It is a~     common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life.~     Unfortunately, it is a very difficult symptom to treat because there are hardly any~     therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the~     condition rather than treating the cause. Tinnitus is thought to be generated in the brain,~     as a result of functional reorganization of auditory neural pathways and tonotopic maps in~     the central auditory system, following damage to the peripheral auditory system. Repetitive~     Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of~     reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural~     circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the~     suppression of tinnitus.~   "
220797|NCT00668707|"~     There is evidence to support the use of melatonin, a natural health product, as an additional~     treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20~     milligrams of melatonin for one year can lower the incidence of developing lung cancer~     recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are~     eligible for surgical resection can participate in the trial. The study will also be~     assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression~     amongst the participants.~   "
220798|NCT00668694|"~     In developing countries, poor nutrition, high morbidity, poverty, poor parental education and~     stimulation in the home, all detrimentally affect children's development. These conditions~     frequently occur together increasing the risk of poor development. Iron deficiency anemia~     (IDA) affects large numbers of young children and is associated with poor child development.~     There is some question as to whether infants with IDA can catch up in mental development to~     non-IDA infants. We plan to examine the effect of psychosocial stimulation on IDA children's~     growth and development using a randomized controlled trial and compare them with non-anemic~     children. The study will be located in poor villages accessible to Dhaka. Villages will be~     randomized to either receive psychosocial stimulation or none. Children, aged 6-12 months,~     with IDA (hemoglobin (Hb) 80.0-109g/L, ferritin<12μg/L & Transferrin Recepter (TfR) >7)~     (n=212) or without anemia (Hb>109g/L, ferritin>12μg/L, C-reactive protein (CRP) <5 & TfR<7)~     (n=212) will be identified in those villages. Intervention will include weekly home visits~     for 9 months by a play leader, who will demonstrate play with home made toys and teach the~     mothers about child development. All IDA children will be given 30 mg ferrous-sulphate daily~     for 9 months. At the beginning and end of the study, the following measurements will be made:~     Bayley Scales of Infant Development (mental and motor indices), Wolke's behavior ratings, Hb,~     serum ferritin, CRP, Transferrin receptor, anthropometry, home stimulation, and mothers'~     knowledge and practices of child development. Stool microscopy, maternal-urinary iodine (as a~     proxy to assess children's iodine status), dietary history, child rearing practices~     (parenting) of mothers, perinatal history and socioeconomic conditions will be assessed at~     the beginning and children's language development at the end. Depending on availability of~     funds serum TSH will also be measured in children to exclude iodine deficiency. We will also~     measure mothers' nutritional and mental status to assess its relationship with children's~     development. The treatment effect will be examined by intention to treat analysis using~     multiple regression of the outcome variables controlling for initial measures and multilevel~     analysis will be conducted to control for differences at village level. The findings of this~     project will have implications both for international and national policies on early~     childhood development programs for IDA children.~   "
220799|NCT00668681|"~     This study is intended to provide data to verify safe delivery of a staple previously~     intended for use in open surgical procedures. A newly modified delivery system will provide~     endovascular access for implantation of a staple during endovascular graft procedures.~   "
220800|NCT00668668|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the~     product Dermacyd Tina Gel Sweet Flower.~   "
220801|NCT00668655|"~     The purpose of this study is to determine the cosmetic appearance of metronidazole gel~     (MetroGel®) 1% with commonly marketed facial foundations.~   "
220805|NCT00668603|"~     Recent large randomized, placebo-controlled studies assessing the health effects of HT~     question the overall benefits of long term HT, especially with respect to cardiovascular~     disease. However, recently menopausal women with severe hot flushes were mostly excluded from~     these trials. This was unfortunate since vasomotor symptoms may reflect different vascular~     sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in~     women with and without hot flushes can differ.~      Aims of the present project are~        1. to compare vascular, cardiac and sympathetic function in recently menopausal women with~          or without severe vasomotor symptoms~        2. in a randomized placebo controlled clinical trial investigate vascular response to oral~          and trans-dermal HT.~   "
220806|NCT00668590|"~     Mounting evidence documents the positive impact of using patient decision aids (PtDA) to~     facilitate shared decision-making (SDM) between patients and physicians in preference~     sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains~     low. More compelling evidence is needed to make the case for policies that would accelerate~     adoption of PtDAs in routine clinical practice in primary care settings that serve diverse~     and economically disadvantaged populations. The investigators believe that it is now time to~     move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials~     of PtDAs, to evaluate whether these tools can also change health behavior and improve health~     outcomes. Therefore, the investigators will build on their expertise in working with~     community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a~     mixed-methods approach. The investigators patient sample will be drawn from primary care~     practices serving African American, Latino and Caucasian patients. The investigators will~     conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA,~     combined with telephone coaching, in increasing patient self-care and self-efficacy,~     increasing diabetes knowledge and improving clinical measures including glycosylated~     hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in~     effects of the patient decision aid, comparing African American, Latino and Caucasian~     patients and conduct in-depth interviews with a randomly selected subset of trial~     participants to explore patient perceptions of the decision aid and variation across~     racial/ethnic groups. The investigators hypothesize that, compared to the control condition,~     participants assigned to receiving the video PtDA program and telephone coaching will report:~     greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better~     glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood~     pressure levels. The conceptual model guiding the investigators trial is the Integrative~     Model of Behavior Change. The model includes three primary determinants of behavior:~        1. attitudes toward performing the behavior~        2. perceived social norms about performing the behavior~        3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these~          constructs directly or indirectly.~   "
220807|NCT00668577|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the~     product Dermacyd Pocket BR.~   "
220808|NCT00668564|"~     The primary objective of this clinical trial is to evaluate the ability to achieve and~     sustain donor engraftment in patients with lysosomal and peroxisomal inborn errors of~     metabolism undergoing hematopoietic stem cell transplantation (HCT).~   "
220809|NCT00668551|"~     To eliminate barriers (such as travel and cost) to specialized Parkinson disease (PD) care,~     two movement disorder specialists at the University of Rochester will be providing~     telemedicine visits for patients with PD who reside in the Presbyterian Home for Central New~     York in New Hartford, NY, or for individuals who participate in the local support group that~     meets at the nursing home. Participants will attend 3 telemedicine visits at the Presbyterian~     Home over the course of 6 months.~      We hypothesize that this telemedicine model will in time improve access to care and hence the~     quality of life and quality of care of individuals with PD.~   "
220810|NCT00668538|"~     The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole~     when used as a vaginal suppository in young women. The investigators want to know if the~     uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).~   "
220811|NCT00668525|"~     This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram~     in adult patients (18 to 65 years of age) with moderate to severe depression. Patients~     completing the study may be eligible to enter a long-term open-label extension study with~     escitalopram.~   "
220812|NCT00668512|"~     This is a Phase I pilot study to evaluate the toxicity of two intra-tumoral injections of GSL~     alpha-GAL in patients with advanced or metastatic cutaneous melanoma. Patients who have~     failed standard therapies or are not eligible for standard treatment will be eligible for~     this study.~   "
220813|NCT00668499|"~     This will be a single institution non-randomized phase I/II trial for patients with malignant~     mesothelioma stage II and above, who have not received prior chemotherapy for their disease.~      The purpose of this phase is to select a dose of VEGF-AS (antiangiogenesis drug)to be given~     with standard doses of pemetrexed followed by cisplatin on day 1 of a 21-day cycle.~   "
220814|NCT00668486|"~     The purpose of this study is to prove the absence of photo irritation and photo sensitivity~     potential of the product Dermacyd Breeze.~   "
220815|NCT00668473|"~     We propose to examine several angiogenic/angiostatic mediators in the skin and serum of~     subjects with SSc and compare it to levels found in the skin and serum of healthy subjects.~   "
220816|NCT00668460|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the~     product Dermacyd Pocket BR.~   "
220817|NCT00668447|"~     The purpose of this study is to test the effect of 1 year of added dietary soy protein and/or~     soy isoflavones on bone mineral density in late postmenopausal women.~   "
220818|NCT00668434|"~     Sciatica is a condition that causes a sharp, burning pain in the back, buttock, and leg. The~     condition is caused by injury to or compression of the sciatic nerve, which is located in the~     back of the leg. This study will determine the effectiveness of the steroid prednisone in~     decreasing pain and improving function in people with sciatica.~   "
220831|NCT00668265|"~     This is a 16 week study of the efficacy of quetiapine in treating symptoms of generalized~     anxiety disorder (GAD) in subjects with comorbid opiate dependence. The study will be~     conducted in a prospective, randomized, double-blind, and placebo-controlled fashion. Study~     subjects will be inpatients at a residential drug-treatment facility, enrolled in a 1 year~     methadone-to-abstinence treatment plan. Subjects will be randomized to receive either~     quetiapine or placebo in addition to ongoing drug addiction treatment. Subjects will be~     followed for 16 weeks and a variety of psychometric assessments will be made.~      Hypothesis One: Compared to placebo, Quetiapine will demonstrate a greater reduction in~     symptoms of anxiety in subjects with GAD and remitted comorbid opiate abuse.~      Exploratory Hypotheses: Compared to placebo, Quetiapine will demonstrate a greater~     improvement in psychosocial functioning and compliance with community norms in subjects~     enrolled in a residential drug addiction treatment facility.~   "
220851|NCT00668005|"~     Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure~   "
220819|NCT00668421|"~     Myelofibrosis is the gradual replacement of bone marrow (place where most new blood cells are~     produced) by fibrous tissue which reduces the body's ability to produce new blood cells and~     results in the development of chronic anemia (low red blood cell count). One of the main~     distinctions of myelofibrosis is extramedullary hematopoesis, the migration or traveling of~     the blood-forming cells out of the bones to other parts of the body, such as the liver or~     spleen, resulting in an enlarged spleen and liver.~      Treatment for myelofibrosis is unsatisfactory and there is no medication that is specifically~     used in the treatment of myelofibrosis. There is a protein that is found to be present in the~     majority of myelofibrosis patients (JAK2) and the drug Lestaurtinib is being studied to see~     if it will stop this protein from functioning and thereby help control the disease.~      This study is divided into two Phases (1 & 2). In phase 1 we will be looking for the dose of~     study medication (Lestaurtinib) that will be the highest dose a patient can take without~     experiencing serious side effects, maximum tolerated dose (MTD).~      In phase 2, after the MTD dose has been established in phase 1, we will be investigating how~     well CEP-701 (Lestaurtinib) works at suppressing the protein (JAK2).~      The investigators also wish to find out important biologic characteristics or features of~     myelofibrosis through an additional correlative biomarker study (MPD-RC #107). The~     correlative biomarker study is a study that is related to the main study, but is looking to~     answer different questions than the main study. The purpose of the biomarker study is to~     understand the causes of MPD and to develop improved methods for the diagnosis and treatment~     of these diseases, while the main study is trying to find out how well CEP-701 (Lestaurtinib)~     will work in treating the myeloproliferative disease.~   "
220820|NCT00668408|"~     In patients with both COPD and CHF, moderate chronic hypoxemia is caused by a combination of~     intrapulmonary and extrapulmonary factors. The hypothesis of this study is that adequate~     medical therapy for both conditions can correct the moderate hypoxemia by improving the~     underlying mechanisms without the need of LTOT. If this hypothesis is correct, the study will~     provide a valuable information to the Italian Agency of drugs (Agenzia Italiana del Farmaco,~     AIFA) to reduce the inappropriate use of LTOT for COPD patients with moderate hypoxemia and~     CHF, and will help the Italian National Health Service to reduce both the direct and indirect~     costs of unnecessary LTOT.~   "
220821|NCT00668395|"~     1. To see how the liver breaks down efavirenz by an enzyme called CYP2B6. It is suggested~          that when Efavirenz is taken repeatedly it may increase the amount of CYP2B6 in your~          liver and thus speed up your liver's ability to get rid of efavirenz from your body.~          This may render efavirenz and other medications ineffective.~        2. To see how efavirenz interact with other drugs taken at the same time with it.~        3. To see if genetic differences can change the way how the liver breaks down efavirenz and~          its interactions with other co-administered drugs.~   "
220822|NCT00668382|"~     This is a Phase I pilot study to evaluate the toxicity and feasibility of intratumoral~     injection (Glycosphingolipids) GSL alpha-GAL (beta-galactosidase) in patients with advanced,~     refractory solid tumors who have failed standard therapies or are not eligible for standard~     treatment.~   "
220823|NCT00668369|"~     Viral infections can profoundly influence alloimmune responses and hamper allograft tolerance~     induction. Persistent hepatitis C virus (HCV) infection occurs in 50% of liver and 20% of~     kidney transplant recipients, but the impact of HCV on the acquisition of allograft tolerance~     has not been elucidated. Liver transplantation constitutes a unique clinical model to address~     this question, given that up to 20% of liver recipients can completely discontinue~     immunosuppressive drugs and attain operational tolerance.~      The goal of our study is to determine the influence of HCV-driven immune responses on the~     acquisition of operational tolerance in liver transplant recipients following drug weaning,~     and to assess whether immunosuppression withdrawal ameliorates HCV-induced liver damage.~      This is a prospective trial in which immunosuppressive drug weaning will be offered to~     HCV-positive liver recipients (selected on the basis of a high likelihood of tolerance) as a~     strategy to improve HCV-mediated liver disease.~   "
220824|NCT00668356|"~     The purpose of this study is to show that the administration of 400/mg/m2/day of~     didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of~     didanosine during fasting, in HIV infected children treated by a ARV combination including~     ddI~   "
220825|NCT00668343|"~     Patient with relapsing remitting multiple sclerosis taking avonex are included in this double~     blind randomized control trial. Simvastatin is compared to placebo. end points of edss ,~     total attack, new enhancing lesion and newt2 lesion in mri is evaluated as end point.~   "
220826|NCT00668330|"~     The primary aim of the present study was to investigate the prevalence of low bone mineral~     density (BMD) and vertebral fractures, as determined by a standardized assessment, and to~     elucidate the role of bone qualities, including micro-architecture, bone remodeling, bone~     turnover, mineralization and inflammation on bone density and prevalent vertebral fractures~     in a large population of systemic lupus erythematosus (SLE) patients.~      The secondary aim of the study is to evaluate the following parameters in women with steroid~     induced OP (SIOP) before and after 1 year of treatment using:~        1. The changes in BMD using dual energy X-ray absorptiometry (DXA)~        2. Bone mineralization and architecture in-vivo using a newly available high-resolution~          human micro-computed tomography (ExtremCT), which can provide us with new insights into~          how the degree and distribution of mineralization are affected by long-term oral~          Ibandronate treatment.~        3. Changes in perfusion and marrow edema before and after treatment of Ibandronate using~          dynamic Magnetic Resonance Imaging (MRI) in these patients with SIOP.~        4. The investigators prospectively evaluate the correlation between the changes in brachial~          arterial endothelial function and lumbar spine BMD in female lupus patients over the~          period of 1 year.~   "
220827|NCT00668317|"~     The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid~     suppression) on bronchial hyper-responsiveness and whether there is a symptomatic~     improvement.~   "
220828|NCT00668304|"~     This study evaluated the time to bacteriological eradication of common pathogens during~     moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the~     time to resolution of key symptoms associated with sinusitis.~   "
220829|NCT00668291|"~     Cohort CNC-PPNAD will be investigated with clinical, genetic, biological and imaging work-up~     every year during 3 years. Cohort L-MC will be investigated clinically at inclusion and a~     PERKAR1A genotype will be performed.~   "
220830|NCT00668278|"~     Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask~     Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak~     airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.~      Hypothesis~      There is no difference between the performance* of the I-gel and disposable laryngeal mask~     airways for controlled ventilation under general anesthesia.~      *as defined by peak airway pressure and sealing pressures.~   "
220832|NCT00668252|"~     The purpose of this study is to determine whether the number of circulating EPC is different~     between healthy women and men.~   "
220835|NCT00668213|"~     Objective:~      The objective of this study was to determine whether the antioxidant supplements used in~     AREDS shifted the plasma pool of the AREDS subjects to a more reduced state. The AREDS~     subjects were randomly assigned to one of four treatment groups:~        1. antioxidants (500mg Vitamin C, 4000IU Vitamin E, 15mg beta carotene)~        2. zinc (80mg zinc oxide, 2mg cupric oxide)~        3. antioxidants plus zinc;~        4. placebo.~      None of the subjects received supplemental GSH or cyst (e) ine.~      Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in~     elderly Americans, with an estimated 15 million people having some form of this disease. AMD~     primarily affects the central vision and many patients develop severe visual handicaps.~      Currently there are no clear established understandings of the etiology or pathogenesis of~     this disease.~   "
220836|NCT00668200|"~     This study will evaluate the impact of investigator and patient education and educational~     materials to foster calcium and vitamin D supplementation to mitigate the potential for~     hypocalcemia post Reclast® administration in patients with Paget's disease of bone.~   "
220837|NCT00668187|"~     Hypothesis: To characterize and describe disease progression and heterogeneity of the~     gangliosidosis diseases.~      This research study seeks to develop a quantitative method to delineate disease progression~     for the gangliosidosis diseases (Tay-Sachs disease, Sandhoff disease, and GM1 gangliosidosis)~     in order to better understand the natural history and heterogeneity of these diseases. Such a~     quantitative method will also be essential for evaluating any treatments that may become~     available in the future, such as gene therapy. The data from this study will be necessary to~     provide end-points for future therapies, guide medical decisions about treatment, provide~     objective measurement of treatment outcomes, and accurately inform parents regarding~     potential outcomes.~   "
220838|NCT00668174|"~     The goals of the study are to examine the effect in postmenopausal women of a one-year~     moderate intensity exercise intervention, as compared with a sedentary pattern (low-level~     stretching program), on: serum estrogens, androgens, sex hormone binding globulin, insulin,~     triglycerides, glucose, aromatase, FSH, LH, as well as parameters of body fat mass.~   "
220839|NCT00668161|"~     There is strong observational epidemiologic evidence that physical activity is inversely~     associated with risk of colon cancer occurrence in both men and women. This association has~     been found in over 30 observational studies, and appears to be independent of effects of~     diet, body fat mass, and other potential confounding factors. Prior to large-scale~     recommendations regarding exercise as a means of preventing colon cancer, however, more~     information is needed regarding the type of exercise, when it must be initiated, and how much~     must be done, in order to produce a protective effect. Information on the mechanisms and~     biological pathways through which exercise might protect the colon will aid in developing the~     answers to these questions.~      This is a randomized controlled trial of a one-year moderate/vigorous exercise intervention~     vs. delayed- exercise control on various biomarkers of colon cancer risk in persons that have~     undergone a colonoscopy within the past 36 months.. The trial is designed to establish the~     effects of the exercise intervention on colorectal cell proliferation and terminal~     differentiation, and on factors that may lie in the pathway between exercise and~     proliferation and apoptosis, in colon and rectal epithelium. It will provide data on: 1) the~     efficacy of a one-year moderate intensity aerobic exercise program in modulating these~     processes to a pattern considered low risk for colon cancer, and 2) the mechanisms whereby~     exercise may lower colon cancer risk in humans. To the investigators' knowledge, this will be~     the first study of its kind.~   "
220840|NCT00668148|"~     This multicenter study will enroll approximately 185 participants with metastatic or advanced~     sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication.~     Participants will be stratified into five tiers according to diagnosis:~        1. Ewing's sarcoma/PNET~        2. rhabdomyosarcoma~        3. leiomyosarcoma~        4. adipocytic sarcoma~        5. synovial sarcoma.~      A total of 85 patients will be enrolled initially, 17 in each tier. Participants will receive~     single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with~     radiological evaluation every cycle.~      Safety and response in the initial 17 patients in each tier will be used to determine whether~     to extend enrollment to the target total of 37 patients per tier.~   "
220841|NCT00668135|"~     To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456)~     compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)~   "
220842|NCT00668122|"~     To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR)~     tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet~     500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial~     urinary tract infections (cUTI).~   "
220843|NCT00668109|"~     Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes,~     hypertension or hyperlipidemia~   "
220844|NCT00668096|"~     The objective of this study was to evaluate the efficacy and tolerability of the~     phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of~     subjects with erectile dysfunction of different aetiologies and severity, who have not been~     previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.~   "
220845|NCT00668083|"~     Observational Retrospective trial on sequential hormonal therapy in patients with Prostate~     Cancer~   "
220846|NCT00668070|"~     The aim of this study is to explore the effect of a new drug (ASP9831) in patients with~     non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and~     biomarkers during a 12 week treatment period~   "
220847|NCT00668057|"~     This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with~     matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.~   "
220848|NCT00668044|"~     This was a non randomised, multi center, italian study performed in burn patients receiving~     an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was~     to validate a pharmacokinetics model useful to verify if a standard dose regimen of~     ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead~     is over or under dosed.~   "
220852|NCT00667992|"~     This study is being carried out to see if budesonide with HFA is effective, safe and well~     tolerated compared with budesonide CFC. Budesonide HFA has been already given in other~     research studies, in both healthy volunteers and subjects with asthma.~   "
220853|NCT00667979|"~     Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection~     sufficient for satisfactory sexual performance. However, there remains no prospectively~     obtained data on the maximal time of effectiveness of vardenafil. The goal of the current~     study was to determine if vardenafil will significantly increase the percentage of successful~     intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12,~     18, and 24 hours were assessed in this pilot study to better quantify the effect of~     vardenafil.~   "
220854|NCT00667966|"~     Assess efficacy of Vardenafil in patients with traumatic spinal cord injury~   "
220855|NCT00667953|"~     This study has been designed to evaluate the side effects of Gleevec when given in~     combination with Temzolomide; and to learn more about how these drugs work in the body and~     whether this combination is useful in treating patients with melanoma.~   "
220856|NCT00667940|"~     We will conduct a faculty development workshop with intent to improve interrater reliability~     and rater accuracy. Outcomes will include interrater reliability, accuracy, and workshop~     evaluations.~   "
220857|NCT00667927|"~     This study proposes to transfer marker genes (detectable genetic traits or segments of DNA~     that can be identified and tracked) into aliquots of marrow obtained for Bone Marrow~     Transplant (BTM) in patients in remission of Acute Myelogenous Leukemia (AML).~   "
220858|NCT00667914|"~     The intention is to evaluate the effectiveness of a multi-factorial medical treatment of~     patients with hip fractures in a specially designed unit for elderly hip fracture patients~     (orthogeriatric unit) as compared to traditional care in an orthopedic unit.~   "
220859|NCT00667901|"~     RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective~     treatment for melanoma.~      PURPOSE: This early phase I trial is studying how well riluzole works in treating patients~     with stage III or stage IV melanoma that can be removed by surgery.~   "
220860|NCT00667888|"~     The goal of this clinical research study is to compare using external beam radiotherapy with~     intensity modulated beams for fewer days at a higher dose per day to the same type of therapy~     for more days at a lower dose per day in the treatment of prostate cancer. The safety of~     these treatments will also be studied and compared.~   "
220861|NCT00667875|"~     The principal aim of this exploratory study is to examine whether the addition of~     aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week~     randomized, placebo-controlled clinical trial, in which all subjects will be provided medical~     management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication~     treatment will reduce drinking compared to placebo treatment alone in the context of medical~     management and whether naltrexone plus aripiprazole will reduce drinking compared to~     naltrexone treatment alone in the context of medical management.~   "
220862|NCT00667862|"~     This Phase II single dose study is designed to characterize the safety, tolerability and~     efficacy of i.v. panobinostat as a single-agent treatment in patients with hormone refractory~     prostate cancer.~   "
220863|NCT00667849|"~     The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on~     tibial fractures treated with intramedullary nailing.~   "
220864|NCT00667836|"~     We propose to establish a multi-center study to investigate the outcome of scoliosis and~     spinal abnormalities in patients with NF1.~      The three specific aims of this study are:~      Specific Aim 1 - To assess health status and health-related quality of life (HRQL) in~     children and adolescents with NF1 and scoliosis. We hypothesize that children and adolescents~     with NF1 and scoliosis will experience an additional burden of morbidity due to scoliosis and~     a downward trajectory of health status and HRQL over time.~      Specific Aim 2 - To assess the natural history and short-term response to therapy in a cohort~     of children with NF1 and scoliosis prospectively diagnosed during the course of the four-year~     study period. We hypothesize that some NF1 patients with idiopathic scoliosis will modulate~     to the dystrophic form. We also hypothesize that NF1 patients with earlier presentation are~     more likely to have or modulate to the dystrophic form.~      Specific Aim 3 - To assess biochemical markers of bone metabolism in NF1 individuals. We~     hypothesize that NF1 individuals will have statistically significant differences in~     biochemical markers of bone metabolism compared to controls. We also hypothesize that NF1~     individuals with scoliosis will have differences in biochemical markers of bone metabolism~     compared to NF1 individuals without scoliosis.~   "
220865|NCT00667823|"~     The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055~     302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in~     patients with symptomatic PAH.~   "
220866|NCT00667810|"~     This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in~     patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab~     or placebo. Each patient's participation will last approximately 1.5 years.~   "
220867|NCT00667797|"~     An analysis of the costs and outcomes associated with hospitalization and treatment of~     Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.~   "
220868|NCT00667784|"~     The goal of this research study is to understand what it is like for a young person to have a~     sick family member and what it is like to donate bone marrow or stem cells for a sick family~     member.~      Primary Aims:~        1. Compare minor donor adjustment to minor non-donor adjustment, including anxiety,~          self-esteem, traumatic stress, achievement, and behavior.~        2. Evaluate minor donor adjustment across time, including self -esteem, traumatic stress,~          anxiety, achievement, and behavior.~        3. Investigate the effect of the following on donor well-being:~             -  Donor variables: 1) the impact of the harvest, including type of harvest (needle~               aspiration of bone marrow or peripheral blood stem cell collection by apheresis~               after injection of G-CSF), pre-procedural anxiety and perceived pain; 2) age of~               donor at time of transplant, 3) gender, 4) preparedness for transplant, 5) sibling~               order (for sibling participants), and 6) donor's decision-making and ambivalence~               regarding donation.~             -  Recipient variables: 1) the recipient's level of well-being or death, 2) genetic~               versus acquired disease types, and 3) familial relationship of donor to recipient.~             -  Family support variables: 1) the distress of the family, 2) the quality of the~               relationship between the potential donor and the recipient, and 3) parent's~               well-being (post-traumatic stress disorder or PTSD, depression).~      Secondary Aim:~      Evaluate satisfaction with the donor program.~   "
220869|NCT00667771|"~     This study will determine whether naltrexone, a medicine used to treat alcoholism, can lessen~     the craving for alcohol during alcohol withdrawal and examine how the drug affects brain~     activity during alcohol infusion.~      People between 21 and 50 years of age who are right-handed, alcohol-dependent, and have at~     least one family member with a history of alcoholism, may be eligible for this study.~      Participants are admitted to the NIH Clinical Center for 1 month for the following~     procedures:~      Screening~        -  Medical history, alcohol-use history and family history of alcoholism~        -  Physical examination, psychological tests and blood tests~        -  Medicine to lessen alcohol withdrawal symptoms, if necessary~      Days 1-7~        -  Alcohol detoxification~        -  Medical and psychological evaluations~        -  Assignment to naltrexone or placebo group~      Days 7 through 28~        -  Drug treatment: Take naltrexone or placebo capsule every morning~        -  Additional alcohol-dependence treatment: Cognitive and behavioral therapies and~          participation in self-help groups, such as Alcoholics Anonymous~        -  Weekly questionnaires to measure mood and desire for alcohol~        -  Blood tests~        -  Alcohol craving stimulation test (day 7): Subjects handle and sniff water and then their~          favorite alcoholic beverage. They then rate their urge to drink alcohol and their level~          of anxiety and their heart rate is measured.~        -  Alcohol infusion test (day 9): Subjects have an MRI scan during infusion through a vein~          of saline (salt water), followed by infusion of alcohol. For this test, a catheter~          (plastic tube) is placed in a vein in each arm, one for administering the saline and~          then alcohol; the other for drawing blood samples to measure blood alcohol level and~          body chemistries. Before, during and after the infusion, subjects are asked to respond~          to questions about their feelings, cravings and mood changes.~      Follow-up~      Subjects are asked to participate in a 3-month outpatient assessment program involving five~     outpatient visits (at 1, 2, 4, 8 and 12 weeks after discharge). At each visit, they fill out~     questionnaires and to take a breathalyzer test and blood and urine tests for drugs. They may~     continue naltrexone therapy and weekly group therapy sessions during this time. Subjects who~     do not participate in the assessment program are contacted at home by phone once a week for 1~     month and then every other week for the next 2 months to monitor alcohol abstinence.~   "
220870|NCT00667758|"~     The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing~     hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe~     rheumatoid arthritis.~   "
220871|NCT00667745|"~     This study evaluated whether lithium included as part of optimized medication treatment~     improved overall level of illness, symptoms of mania and depression, and quality of life in~     people with bipolar disorder.~   "
220872|NCT00667732|"~     This study is designed to look at how using glargine insulin with oral diabetes medications~     and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics.~      The main study will last 32 weeks. However, all participants completing 32 weeks will be~     invited to continue for another 24 weeks taking the insulin and oral medication and exenatide~     treatment. This extension comparing insulin and oral medication with insulin and oral~     medication and exenatide will look at the long term weight loss/gain and blood sugar level~     control effects of this new drug regimen.~      There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour~     inpatient stays during the main study. This study offers the opportunity to study 24-hour~     blood sugar and metabolic patterns quantitatively.~   "
220873|NCT00667719|"~     This study will test the safety of the combination of~     aliskiren/amlodipine/hydrochlorothiazide in patients with essential hypertension~   "
220874|NCT00667706|"~     The sleeve gastrectomy that has been utilized as a first-stage bariatric procedure to reduce~     surgical risk in high-risk patients by induction of weight loss is now gaining popularity as~     a standalone procedure for the treatment of morbid obesity. It appears to be a technically~     easier and/or faster laparoscopic procedure than Roux-en-Y gastric bypass. It brings good~     weight loss results, in some studies even comparable to the RYGB and Biliopancreatic~     Diversion with Duodenal Switch.~      The mechanism of action is assumed to be purely restrictive, but some neurohumoral~     interaction may exist. Almost no data exist on the influence of the sleeve gastrectomy on the~     medical and general quality of life or resolution of comorbidities.~      The rates of the comorbidities resolution 12 to 24 months after sleeve gastrectomy has been~     reported in the range that seems to be higher than for the purely restrictive procedures.~      Our goal is to to compare the surgical and weight loss outcomes between the two procedures,~     their influence on resolution of common comorbidities and on quality of life change.~      150 eligible candidates will be randomized into two groups, one will undergo Laparoscopic~     Sleeve Gastrectomy, the other will have Laparoscopic Roux-en-Y Gastric Bypass done. Detailed~     evaluation and preoperative questionnaires will be used to obtain demographic and medical~     data, and quality of life will be assessed.~      General metabolic and nutritional work up will be done, and will be reassessed at different~     intervals up to 5 years, in order to compare the short and long term results of the two~     procedures.~   "
220875|NCT00667693|"~     This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel~     airway management device that is designed to facilitate laryngoscopy and endotracheal~     intubation.~   "
220876|NCT00667680|"~     tDCS applies a small amount of direct electric current (DC) to the brain by means of two~     electrodes: the one is an active electrode, localized on the effective site, and the other is~     a reference electrode, localized on some silent part of the body. Anodal transcranial~     direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPFC) has been~     associated with working memory enhancement and improvement of mood. This study will~     investigate the possible antidepressant effects of tDCS in patients with therapy resistant~     major depressive episodes.~   "
220877|NCT00667667|"~     There is general agreement that physical exercise can positively influence osteoporotic~     fracture risk along two pathways: first by reducing the risk of falls via an improvement of~     fall related neuromuscular abilities; second by increasing bone strength.~      Whole body vibration (WBV) training has recently been proposed as a new approach for~     prevention and treatment of osteoporosis. Animal studies have shown evidence that WBV may be~     an effective method to improve bone mass, architecture and strength. However, the results of~     human WBV training studies are rather heterogeneous.~      In the Erlangen Longitudinal Vibration Study II (ELVIS II), a randomized, controlled 12 month~     lasting study the investigators determine the effect of a thrice weekly WBV training on two~     different devices on the osteoporotic risk factors: bone mineral density, falls and~     neuromuscular performance. Particular the investigators compare a bipedal vertical~     oscillating Plate with a plate which rotates around a central axis leading to a~     side-alternating loaning.~   "
220878|NCT00667654|"~     This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when~     delivered as an intra-articular injection in the knee. Secondary objectives will be to~     explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.~   "
220897|NCT00667407|"~     To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the~     Treatment of Acute Asthma.~   "
221238|NCT00662948|"~     After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin,~     vincristine and prednisone) the patients are randomized to:~      A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg~      B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months~   "
220879|NCT00667641|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving paclitaxel together with bortezomib may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel and~     bortezomib in treating patients with metastatic or unresectable malignant solid tumors.~   "
220880|NCT00667628|"~     The purpose of this study is to determine whether TAC-101 combined with Transcatheter~     Arterial Chemoembolization (TACE) is more effective than TACE alone in slowing tumor activity~     in patients with advanced hepatocellular carcinoma. The study is also looking at the safety~     of TAC-101 in combination with TACE.~   "
220881|NCT00667615|"~     The purpose of this study is to replace a drug with many side effects, procarbazine, with a~     new novel drug, vorinostat, in a drug combination for the treatment of patients with diffuse~     large B-cell lymphoma. Vorinostat is the first of a new type of chemotherapy drug, known as a~     histone deacetylase inhibitor, to be approved by the Food and Drug Administration. It is~     approved for the treatment of certain lymphomas of the skin. It alters the cancer cell~     pathway by preventing cancer cells from reproducing. Vorinostat will be added to a~     combination of four other effective chemotherapy drugs that have been used for many years for~     the treatment of diffuse large B-cell lymphoma: rituximab, cyclophosphamide, etoposide and~     prednisone. The doses of vorinostat will be increased or decreased depending on the side~     effects that occur in each of the first few patients in the trial to find the safest dose~     with the least side effects. This is termed the phase I part of the clinical trial. Once the~     best dose of vorinostat is found, the rest of the patients in the clinical trial will be~     treated with this dose. This is termed the phase II part of the trial. The object of the~     trial is to find out what effects, good and/or bad, the combination of vorinostat, rituximab,~     cyclophosphamide, etoposide and prednisone will have on you and your lymphoma.~   "
220882|NCT00667602|"~     The primary immunogenicity objective is to assess and compare the immunogenicity of one dose~     of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured~     by the percentage of subjects with serum bactericidal titers directed against N. meningitidis~     serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).~   "
220883|NCT00667589|"~     The purpose of this study is to evaluate treatments for a rash caused by sorafenib.~   "
220884|NCT00667576|"~     The purpose of this study was to investigate the initial dose and dose adjustment range for~     paricalcitol injection in patients with chronic kidney disease on hemodialysis who have~     secondary hyperparathyroidism.~   "
220885|NCT00667563|"~     RATIONALE: Vaccines made from virus proteins may help the body build an effective immune~     response to prevent cervical cancer.~      PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine~     and how well it works in preventing cervical cancer in women in India with HIV-1 infection.~   "
220886|NCT00667550|"~     This is a prevalence study evaluating lower urinary tract, prolapse, bowel, and sexual~     symptoms in women with a colorectal disorder who are planning to undergo surgery.~      The purpose of this study is to identify the number of women who complain of lower urinary~     tract and bowel problems, including frequency, urgency, urinary incontinence, fecal~     incontinence, pain with intercourse, and other sexual problems prior to undergoing surgical~     management for a colorectal disorder.~   "
220887|NCT00667537|"~     Primary objective: To investigate the biodistribution, radiation dosimetry, and~     pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body~     weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology~     standardization], 6 weeks apart).~      Secondary objectives: To determine the safety of IV injections of Xofigo after two separate~     injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic~     bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w.~     (=110 kBq/kg based on the 2015 National Institute of Standards and Technology~     standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect~     survival data at 6 and 12 months after the first injection~   "
220888|NCT00667524|"~     A database analysis and review of histological slides (retrospective) and a patient~     questionnaire analysis (prospective) will be conducted in Bern (Switzerland) to evaluate the~     efficacy and safety of esophageal dilation and its effect on the underlying eosinophilic~     inflammation in patients with Eosinophilic Esophagitis. This trial is investigator driven.~   "
220889|NCT00667511|"~     The purpose of this study is to determine whether or not nocturnal hemodialysis is equivalent~     to short daily hemodialysis on a per treatment basis, using the NxStage System One in the~     home setting.~   "
220890|NCT00667498|"~     The primary objective of this randomized, parallel group, double-blind, placebo-controlled~     study is to determine whether treatment with metformin enhances insulin sensitivity in a~     group of ethnically diverse obese insulin-resistant adolescents with normal glucose~     tolerance.~   "
220891|NCT00667485|"~     The goal of this trial is to determine the toxicity and maximum dose of rapamycin and~     bevacizumab given together to subjects with advanced cancers. This study will also look at~     the pharmacokinetics and antitumor activity of the combination.~   "
220892|NCT00667472|"~     The purpose of this study is to improve port wine stain therapeutic outcome in response to~     laser therapy. The researcher want to determine whether the combined use of pulsed dye laser~     therapy and topical ranibizumab will improve port wine stain therapeutic outcome.~   "
220893|NCT00667459|"~     The purpose of this clinical trial is to evaluate the safety and effectiveness of the~     PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical~     degenerative disc disease at a single level from C3-C4 to C6-C7.~   "
220894|NCT00667446|"~     The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30~     mg) is safe in treating children with Central Precocious Puberty over a longer period of time~     (36 months).~   "
220895|NCT00667433|"~     This is a single arm, longitudinal study to examine the safety, tolerability, and~     pharmacokinetic and metabolic characteristics of Raltegravir among 40 African-American,~     HIV-infected, patients.~   "
220896|NCT00667420|"~     A pilot study to determine the safety of using perioperative panitumumab with EOX~     (epirubicin, oxaliplatin, and capecitabine) in patients with adenocarcinoma of the esophagus~     and stomach.~   "
220898|NCT00667394|"~     Background:~      In order to survive, brain tumors must have a network of blood vessels to supply it with~     oxygen and nutrients. The tumors produce substances that enable new blood vessels to form.~      Tandutinib and Bevacizumab are experimental drugs that may prevent new blood vessel formation~     and thereby slow or stop tumor growth in the brain.~      Objectives:~      To determine the safety and side effects of Tandutinib in combination with Bevacizumab in~     patients with brain tumors.~      To evaluate the response of brain tumors to treatment with Tandutinib and Bevacizumab.~      Eligibility:~      Patients 18 years of age and older with a malignant brain tumor for whom standard treatments~     (surgery, radiation and chemotherapy) are no longer effective.~      Design:~      Patients receive treatment in 4-week cycles as follows: Tandutinib by mouth twice a day every~     day and intravenous (through a vein) infusions of Bevacizumab over 90 minutes (or less if~     well tolerated) every 2 weeks. Treatment may continue for up to 1 year, and possibly longer,~     as long as there are no signs of tumor growth or serious treatment side effects.~      Patients are evaluated with magnetic resonance imaging (MRI), computed tomography (CT) and~     positron emission tomography (PET) scans before starting treatment and then periodically to~     determine the response to treatment.~      Patients have physical and neurological examinations every 4 weeks and blood tests every 2~     weeks. They complete quality of life questionnaires every 4 weeks.~   "
220899|NCT00667381|"~     This study is designed to evaluate the routine use of vascular ultrasound as an aid for~     proper placement of a femoral arterial sheath during cardiac catheterization and peripheral~     arterial angiography.~   "
220900|NCT00667368|"~     The purpose of this study is to determine whether regular screening (every 2 months) and~     treatment for bacterial vaginosis (BV [infection of the vagina]) will reduce the number of~     incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a~     year. Chlamydial and gonococcal infections will be determined by vaginal swab testing at 4,~     8, and 12 months after enrollment. Subjects will include 1500 women aged 15-25 years who have~     clinical evidence of BV, with no symptoms. Subjects will be randomly assigned to 1 of 2~     possible study groups: the intervention group (treatment of BV) or the control group (no BV~     treatment). Every 2 months, subjects will complete a home self-testing kit for screening of~     BV using a swab. If BV is detected by self-test, the subjects in the interventional group~     will receive a 7 day course of the antibiotic metronidazole. Participants will be involved in~     study related procedures for up to 12 months.~   "
220901|NCT00667355|"~     To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with~     active ankylosing spondylitis~   "
220902|NCT00667342|"~     This study adopts a novel strategy for first-line treatment of osteosarcoma by combining~     chemotherapy with anti-angiogenic therapy using bevacizumab (Avastin®), a humanized~     monoclonal antibody against vascular endothelial growth factor (VEGF). Chemotherapy for~     localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose~     methotrexate). Chemotherapy for metastatic or unresectable disease comprises a~     cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and~     etoposide.~   "
220903|NCT00667329|"~     The goal of this clinical research study is to see how well the drugs 2CdA, cyclophosphamide,~     and rituximab (rituxan) shrink a lymphoma called Waldenstrom's macroglobulinemia. After these~     drugs are given for 2 courses, a second goal is to see how long a remission lasts. A third~     goal is to see how often repeat remissions can be achieved when the lymphoma returns later~     and the same drugs are restarted.~      This is an investigational study. The FDA has approved each of these drugs for the treatment~     of low-grade lymphoma. The combined use of these drugs for Waldenstrom's macroglobulinemia is~     investigational, although each drug has been effective by itself for this disease. About 50~     patients will take part in this study. This study will take place only at UTMDACC (outpatient~     basis).~   "
220904|NCT00667316|"~     The purpose of this study is to determine, in Spanish workers, the influence of different~     factors (personal, psychological, work related and clinical) on the risk of being on sick~     leave during the 18 months after baseline assessment, and on the duration of that sick leave.~   "
220905|NCT00667303|"~     The Study aims to prospectively survey the incidence of respiratory virus infections using~     molecular methodologies, in children undergoing hematopoietic stem cell transplantation~   "
220906|NCT00667290|"~     The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation~     program will improve claudication distances, free-living daily physical activity, and~     health-related quality of life of older, revascularized patients with peripheral arterial~     disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation~     affects the above functional outcomes are through alterations in walking efficiency,~     peripheral circulation, and cardiopulmonary function.~   "
220907|NCT00667277|"~     Myelofibrosis is the gradual replacement of bone marrow (place where most new blood cells are~     produced) by fibrous tissue which reduces the body's ability to produce new blood cells and~     results in the development of chronic anemia (low red blood cell count). One of the main~     distinctions of myelofibrosis is extramedullary hematopoiesis, the migration or traveling~     of the blood-forming cells out of the bones to other parts of the body, such as the liver or~     spleen, resulting in an enlarged spleen and liver.~      There is not a standard treatment for myelofibrosis, therefore there is no medication that is~     specifically used in the treatment of myelofibrosis. Bevacizumab (Avastin®) targets and stops~     a growth factor in the body that helps produce the type of fibrous tissue that is gradually~     replacing the bone marrow in the bones.~      The purpose of this study is to find out how safe and effective bevacizumab is in treating~     myelofibrosis. The investigators also wish to find out important biologic characteristics or~     features of myelofibrosis (how it works and operates) during the time of study participation~     through an additional correlative biomarker study (MPD-RC #107). The purpose of the biomarker~     study is to understand the causes of MPD and to develop improved methods for the diagnosis~     and treatment of these diseases, while the main study is trying to find out how well~     bevacizumab will work in treating the disease.~   "
220908|NCT00667264|"~     Research study to determine if putting local anesthetic—or numbing medication—through one or~     two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom~     limb and/or stump pain.~   "
220936|NCT00666900|"~     The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating~     patients with acne vulgaris.~   "
220909|NCT00667251|"~     RATIONALE: HER2/neu is a receptor (protein) which is found in unusually high amounts in~     approximately 1 in 5 cancer patients. Scientific evidence suggests that having high amounts~     of the HER2/neu receptor is important for breast cancer to grow and spread. Women with~     previously untreated metastatic breast cancer (breast cancer that has spread to other organs)~     and with high levels of the HER2/neu receptor receive as their usual treatment chemotherapy~     with one of the approved chemotherapy drugs paclitaxel or docetaxel (called taxanes)~     together with another approved drug called trastuzumab. Chemotherapy drugs, such as~     paclitaxel and docetaxel, work either by killing tumour cells or by stopping them from~     dividing. Trastuzumab is an antibody that is given through a vein in the arm and it works by~     specifically targeting the HER2/neu i.e. it attaches to it and turns it off. Although~     some of the patients who receive this taxane plus trastuzumab treatment feel better for some~     months, the cancer usually starts to grow again. Lapatinib is a new drug. Like trastuzumab,~     it also works by specifically targeting the HER2/neu receptor, but it does so in a~     different way. Lapatinib is not an antibody. It is a pill that is taken daily by mouth.~     Because lapatinib works in a different way than trastuzumab, it may be worse, as good as or~     better than trastuzumab in keeping metastatic HER/neu positive cancer from growing. However,~     this is not known.~      Purpose: This randomized Phase III trial is comparing chemotherapy (a taxane) given together~     with lapatinib with chemotherapy (a taxane) given together with trastuzumab in women with~     HER2/neu positive breast cancer.~   "
220910|NCT00667238|"~     The purpose will be to study the functional impact of pediatric chronic pain on children, and~     their families. Focus will be on the impact of pain on school functioning, social~     functioning, psychological functioning and family functioning of pediatric chronic pain.~   "
220911|NCT00667225|"~     The University of North Carolina Department of Dermatology is conducting a clinical trial to~     evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a~     common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many~     flesh-colored bumps on the skin. It goes away on its own, though can last several months to~     several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is~     well tolerated by the majority of children.~   "
220912|NCT00667212|"~     The goal of this study is to examine the effectiveness two forms of psychotherapy (also known~     as talk therapy ) for individuals with anger and aggression problems. Anger and aggression~     are everywhere - on the road, in the schools, at little league games, at home, and at work.~     In this study we are testing usefulness of anger management techniques in reducing symptoms~     of Intermittent Explosive Disorder (IED) and impulsive, aggressive behavior.~   "
220913|NCT00667199|"~     The purpose of this study is to evaluate the efficacy and safety of the investigational~     radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and~     bone metastases that no longer respond to hormonal treatment.~   "
220914|NCT00667186|"~     Late diagnosis of HIV infection is believed to be responsible for high rates of HIV~     transmission. The purpose of this study is to determine whether targeted screening versus~     routine screening will identify a greater number of HIV infected participants. This study~     will also compare the costs of the resources used for targeted screening versus routine~     screening.~   "
220915|NCT00667173|"~     The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating~     patients with rosacea.~   "
220916|NCT00667160|"~     A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic~     Dermatitis in pediatric patients~   "
220917|NCT00667147|"~     This study uses the drugs Abraxane (also called ABI-007) and Vandetanib (also called Zactima~     and ZD6474). Abraxane has been approved by the Food and Drug Administration (FDA), for the~     treatment of breast cancer. Vandetanib is an experimental drug and has not been approved by~     the FDA for the treatment of any condition. Vandetanib has shrunk some non-small cell lung~     cancer, prostate cancer and thyroid cancer in some studies in humans. This combination of~     drugs is not approved for the treatment of any condition by the FDA.~      This study is being done in two phases. The first phase of the trial has two main objectives:~     1) To find the highest daily dose of vandetanib that can be given safely with once weekly~     Abraxane and 2) To find the highest daily dose of vandetanib that can be given safely with~     Abraxane given every three weeks. Participants will be randomly assigned (like flipping a~     coin) to receive Abraxane weekly (Arm A) or once every three weeks (Arm B). The dose of~     Abraxane given will remain the same for the whole study - 100 mg/m2 when given weekly and 260~     mg/m2 when given every three weeks. Participants will be entered onto each arm of the study~     in groups of three, and higher doses of vandetanib will be given each group of participants.~     The increase of vandetanib will stop once more than one participant has serious side effects.~     The highest dose of vandetanib that can be given with Abraxane (without serious side effects)~     in each Arm will be called the pilot dose.~      In the second phase of the study twenty participants will be randomly assigned to Arm A or~     Arm B and receive the pilot dose of vandetanib that was reached in the first phase of the~     study. The purpose of the second phase of the study is to see how many tumors shrink when~     participants receive the pilot dose of the drug combination on each Arm, as well as to gather~     more information about the side effects.~   "
220918|NCT00667134|"~     This study is to determine if subjects with .systemic sclerosis have stimulatory~     autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF~     receptor in skin sites with varying degrees of skin thickening~   "
220919|NCT00667121|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving tamoxifen may~     help doctors learn more about the effects of other drugs on the level of tamoxifen in the~     blood.~      PURPOSE: This clinical trial is studying levels of tamoxifen in the blood of women with~     breast cancer and in women at high risk of breast cancer who are receiving tamoxifen together~     with venlafaxine, citalopram, escitalopram, gabapentin, or sertraline.~   "
220920|NCT00667108|"~     The purpose of this study is to assess the effect of gabapentin as compared to placebo on~     sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a~     sleep phase advance.~   "
220921|NCT00667095|"~     The purpose of this study is to determine whether women with overactive bladder (OAB) who~     receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl~     Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms~     when compared to a similar group of women with OAB who receive instillation of DMSO only.~   "
220922|NCT00667082|"~     This is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and~     efficacy of IV NPI-0052 (a proteasome inhibitor) in combination with oral vorinostat~     (Zolinza; a HDAC inhibitor) in patients with non-small cell lung cancer, pancreatic cancer,~     melanoma or lymphoma. Proteasome inhibitors block the breakdown of proteins by cells and HDAC~     inhibitors block modification of proteins regulating gene expression in cells. Both of these~     actions preferentially affect cancer cells, and the combination of the two has been seen to~     have a greater effect in laboratory studies.~   "
222202|NCT00650286|"~     The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg~     tablets to Cephalon Provigil® 200 mg tablets following a single, oral 200 mg (1 x 200 mg)~     dose administration under fed conditions.~   "
220923|NCT00667069|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such~     as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses~     high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and~     radiation therapy soon after surgery or later after surgery is more effective in treating~     prostate cancer.~      PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy~     soon after surgery to see how well it works compared with giving them later after surgery in~     treating patients who have undergone surgery for intermediate-risk stage III or stage IV~     prostate cancer.~   "
220924|NCT00667056|"~     A study of subjects with a known nickel allergy comparing Tacrolimus to placebo, both~     associated with nickel patches to determine the safety and efficacy of treating Chronic~     Allergic Contact Dermatitis with Tacrolimus Ointment~   "
220925|NCT00667043|"~     The aim of this study is to increase knowledge about drug properties and effects during~     therapeutic hypothermia. The primary end point of this study is the time from termination of~     sedation to extubation in patients treated with therapeutic hypothermia, after treatment with~     the combination remifentanil and propofol versus that of fentanyl and midazolam.~   "
220926|NCT00667030|"~     Over half of adults in this country are overweight. This increases risk for heart and blood~     pressure problems, cancer, stroke and arthritis. While it is difficult to lose large amounts~     of weight and keep it off, even small amounts of weight loss can improve health. Furthermore,~     fat is increasingly recognized as a source of substances that increase inflammation. It may~     be that some of the adverse consequences of being overweight are due to increased~     inflammation. We are asking you to volunteer for a research study in which you may lose a~     moderate amount of weight and increase your activity. It is important that you read and~     understand the information on this form.~      The purposes of these studies are to determine the influence(s) of age and body composition~     on the production of inflammatory chemicals by fat (adipose tissue), the mechanisms~     controlling this, and if a weight loss and aerobic exercise intervention results in a~     decrease in inflammation.~   "
220927|NCT00667017|"~     RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin~     IMTOX25), can find certain cancer cells and kill them without harming normal cells.~      PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25~     and how well it works in treating patients with relapsed or refractory cutaneous T-cell~     non-Hodgkin lymphoma.~   "
220928|NCT00667004|"~     Efficacy study of ecabet ophthalmic solution in dry eye disease~   "
220929|NCT00666991|"~     The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary~     efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in~     patients with refractory malignancies principally confined to the peritoneal cavity.~   "
220930|NCT00666978|"~     RATIONALE: A stop-smoking plan that includes health education counseling and bupropion may~     help African-American smokers stop smoking. It is not yet known whether health education~     counseling is more effective with or without bupropion in helping African Americans stop~     smoking.~      PURPOSE: This clinical trial is studying health education counseling and bupropion to see how~     well they work compared with a placebo and health education counseling in helping African~     Americans smokers stop smoking.~   "
220931|NCT00666965|"~     The primary objective of this study is to investigate efficacy and safety of SPM 962 in~     Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group~     comparative study following once-daily multiple transdermal doses of SPM 962 within a range~     of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.~   "
220932|NCT00666952|"~     Morbid obesity currently affects more than 11 million US adults and is strongly associated~     with type 2 diabetes, cancer, cardiovascular disease, and arthritis. Bariatric (weight loss)~     surgical procedures have been shown to significantly reduce body weight and improve the~     health and quality of life of morbidly obese adults, at least in the short term. However,~     bariatric surgery also presents substantial risks, including a 10% to 20% risk of serious~     complications and up to a 2% risk of death in the first 30 days after surgery. Thus, a~     morbidly obese patient's decision regarding bariatric surgery should be based on his or her~     evaluation of accurate information on the possible risks and benefits of the various~     treatment options. Anecdotal reports suggest that bariatric treatment decisions may be more~     heavily influenced by insurance coverage and reimbursement rates than patient preferences.~      The main objective of the current proposal is to examine the impact of a bariatric decision~     aid, Weight loss surgery: Is it right for you?, on decision quality in primary care and~     bariatric specialty practice settings. We propose a randomized controlled trial to assess the~     effect of this bariatric decision aid on bariatric-specific measures of patient knowledge,~     values and choice of weight management strategy. We will also investigate the effect of the~     decision aid on decisional conflict and decisional self-efficacy and examine medical,~     psychological, and behavioral factors as mediators and moderators of treatment choice. This~     information will help to elucidate the value of this decision aid in improving decision~     quality.~      The primary aims of this of this research are to:~        1. Determine if the bariatric decision aid results in superior bariatric surgery decision~          quality than an NIH booklet on weight loss surgery ('usual care').~        2. Determine if the bariatric decision aid results in less decisional conflict and superior~          decisional self-efficacy than usual care.~        3. Determine if there is a differential effect of the interventions on decision quality~          among treatment seekers and non-treatment seekers.~        4. Investigate medical, psychological, and behavioral factors as mediators of treatment~          choice.~      The secondary aims of this study are to:~        1. Understand the current weight control attitudes and practices among morbidly obese~          patients who are not actively seeking bariatric surgical treatment.~        2. Assess the rates of bariatric surgery, health care costs, health care use and outcomes,~          and changes in BMI over time across the intervention groups, as well as across study~          subgroups, such as those who did and did not choose to have bariatric surgery.~      We hypothesize that the decision aid will result in greater knowledge and greater values~     concordance, less decisional conflict and superior decisional self-efficacy than the NIH~     booklet.~   "
220933|NCT00666939|"~     The purpose of this study is to assess the effect of gabapentin as compared to placebo on~     sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a~     sleep phase advance.~   "
220934|NCT00666926|"~     Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase~     (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography [PET]~     scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and~     prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy.~     Screening consists of a Fluorodeoxyglucose Positron Emission Tomography [FDG-PET] and tumor~     imaging, medical history, physical examination, Eastern Cooperative Oncology Group [ECOG]~     performance status, blood draws, a pregnancy test for female patients of childbearing~     potential. Treatment consists of PF00562271 tablets continued until progression of disease,~     unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial~     FDG-PET and blood tests for biomarkers related to FAK and PYK2 kinase activities.~   "
220935|NCT00666913|"~     RATIONALE: Gathering information about the frequency and intensity of hot flashes in patients~     with breast cancer and in patients who have a high risk of developing breast cancer may help~     doctors learn more about menopausal symptoms.~      PURPOSE: This clinical trial is looking at menopausal symptoms in women with breast cancer or~     at high risk of breast cancer who received treatment on another clinical trial.~   "
220937|NCT00666887|"~     The aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces~     the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to~     placebo, over a 6 month follow-up period (primary outcome).~      A key secondary outcome is to confirm that this early treatment benefit is maintained at two~     years.~   "
220938|NCT00666874|"~     Obesity is an independent risk factor for cardiovascular disease, which may be mediated by~     increased secretion of proinflammatory cytokines by adipose tissue.~      To determine the effect of a program of changes in lifestyle designed to obtain a sustained~     reduction of body weight on markers of systemic vascular inflammation and insulin resistance.~      Randomized single-blind trial conducted from February 1999 to February 2002 at a university~     hospital in Italy.~      One hundred twenty premenopausal obese women (body mass index 30) aged 20 to 46 years without~     diabetes, hypertension, or hyperlipidemia.~      The 60 women randomly assigned to the intervention group received detailed advice about how~     to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet~     and increased physical activity. The control group (n = 60) was given general information~     about healthy food choices and exercise.~   "
220939|NCT00666861|"~     A randomised, cross-over trial targeting a small sample of older (age 45-65 years) overweight~     adults with type 2 diabetes the aims of this pilot study are to:~        1. Determine the feasibility of investigating the acute effects of prolonged sedentary~          behaviour (sitting) in this target group.~        2. Compare the acute effects of a single prolonged (8 hour) bout of sedentary behaviour~          (sitting) on glucose and triglyceride concentrations and key muscle and adipose~          regulatory enzymes to a similar bout of sedentary behaviour combined with intermittent~          bouts of light-intensity activity.~   "
220940|NCT00666848|"~     This study will measure the effect of the anti-diabetic agent sitagliptin on blood pressure~     in individuals with the metabolic syndrome. We will also measure the effect of sitagliptin on~     blood pressure in people already taking a blood pressure medication called an ACE inhibitor.~   "
220941|NCT00666835|"~     This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving~     about 462 clinically stable hemodialysis patients aged 18 years or above suffering from~     anemia and treated previously with a stable dose of ERYPO® intravenously.~   "
220942|NCT00666822|"~     RATIONALE: Understanding how well patients comply with their treatment regimen may help~     doctors plan the best treatment and ongoing care.~      PURPOSE: This clinical trial is studying whether patients comply with their hormone therapy~     regimen in women with estrogen receptor-positive stage I, stage II, or stage IIIA breast~     cancer.~   "
220943|NCT00666809|"~     There is incidental evidence (casuistic findings) that the treatment with vardenafil of male~     patients suffering from erectile dysfunction and comorbid tinnitus experienced an improvement~     of their tinnitus.~      Randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of~     treatment + 4 weeks follow-up) with 10 mg vardenafil BID p.o. in men and women with chronic~     tinnitus.~   "
220944|NCT00666796|"~     The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and~     ethanol~   "
220945|NCT00666783|"~     This clinical study was designed to demonstrate that a single, intravenous dose of~     palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed~     CINV and was also well tolerated in the Chinese cancer patients.~   "
220946|NCT00666770|"~     The purpose of this study is to assess the effect of gabapentin as compared to placebo on~     sleep in subjects with transient insomnia.~   "
220947|NCT00666757|"~     The purpose of this study is to compare duloxetine with other antidepressants in the~     treatment of severe depression.~   "
220948|NCT00666744|"~     The aim of the study is to evaluate the functional recovery in two groups of primary stroke~     patients presenting with moderate/severe disability over a six month period through the~     implementation of a randomised controlled trial. The first group or the experimental group~     will receive routine therapy and additional lower limb exercise therapy in the form of family~     assisted exercises. The second group or the control group will receive routine therapy with~     no additional formal input from their family members. A secondary aim of the project is to~     evaluate the impact of the FAME programme on the person with stroke and the individual (s)~     assisting in the delivery of exercises.~   "
220949|NCT00666731|"~     RATIONALE: Gathering information about patients with breast cancer and their families may~     help the study of breast cancer in the future.~      PURPOSE: This clinical trial is gathering information about patients with breast cancer and~     their families.~   "
220950|NCT00666718|"~     This study is designed to look at if a basal bolus regimen of insulin lispro protamine~     suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin~     glargine (when one basal bolus regimen is injected once daily together with insulin lispro~     injected 2-3 times daily).~   "
220951|NCT00666705|"~     An open label study to evaluate an interaction between maraviroc and raltegravir in healthy~     subjects.~   "
220952|NCT00666692|"~     The primary purpose of this study is to examine the safety of volociximab (V) in combination~     with a standard treatment of carboplatin (C), paclitaxel (P), and bevacizumab (B) in subjects~     previously untreated with chemotherapy for advanced stage (IIIB/IV) non-squamous non-small~     cell lung cancer (NSCLC).~   "
220953|NCT00666679|"~     This study assesses inhaled corticosteroid plus montelukast compared with inhaled~     corticosteroid therapy alone for treatment of patients with chronic asthma.~   "
220954|NCT00666666|"~     This phase II trial is studying how well giving gossypol together with androgen ablation~     therapy works in treating patients with newly diagnosed metastatic prostate cancer. Gossypol~     may stop the growth of tumor cells by blocking blood flow to the tumor. Androgens can cause~     the growth of prostate tumor cells. Luteinizing hormone-releasing hormone agonists and drugs,~     such as bicalutamide, may lessen the amount of androgens made by the body. Giving gossypol~     together with androgen ablation therapy may be an effective treatment for prostate cancer~   "
220955|NCT00666653|"~     The purpose of this study is to determine whether there is a benefit to giving a dopamine~     agonist to a patient with Parkinson's disease who is already being treated with levodopa.~   "
220970|NCT00666458|"~     Saxagliptin is a new investigational medication being developed for treatment of type 2~     diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in~     addition to metformin and compare to sitagliptin in addition with metformin.~   "
220956|NCT00666640|"~     The study aims to determine the efficacy and best methods for predicting hip fractures and~     diagnosing post-menopausal osteoporosis using three dimensional structural engineering models~     (SEMs) of proximal femoral bone produced using a Hologic Discovery duel-energy x-ray~     absorptiometry scanner and Hologic's new 3D Hip(TM) software in comparison to three~     dimensional SEMs produced using quantitative computed tomography - the current gold standard.~   "
220957|NCT00666627|"~     A study to determine if the three licensed bisphosphonates (alendronate, ibandronate and~     risedronate):a) affect the peripheral skeleton differently, as assessed by quantitative~     ultrasound of bone (QUS), peripheral quantitative computed tomography (pQCT) and dual−energy~     x−ray absorptiometry (DXA)? b) have different effects on bone cells and their activity as~     assessed by flow cytometry and biochemical markers of bone cell activity? The aim of the~     study is to compare the effects of three licensed bisphosphonates on bone quantity and~     quality. There has been no such study before. Most of the measures of bone quantity and~     quality used in this protocol have not been studied with any of these three agents. The~     novelty of the study necessitates the establishment of reference ranges and this explains the~     need for the inclusion of a group of young women.~   "
220958|NCT00666614|"~     The purpose of this pilot study is to determine if patients randomized to a hospital sleep~     environment intervention would have improved sleep quality and reduced fatigue as compared to~     the patients not receiving the intervention (standard care).~   "
220959|NCT00666601|"~     The purpose of this study is to measure the penetration of TR-700 into subcutaneous adipose~     tissue and skeletal muscle after a single oral dose of 600 mg TR-701~   "
220960|NCT00666588|"~     This phase II trial is studying the side effects and best dose of bortezomib and to see how~     well it works when given together with combination chemotherapy in treating younger patients~     with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may~     kill more cancer cells~   "
220961|NCT00666575|"~     The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a~     potential over-the-counter population with reports of occasional sleeplessness~   "
220962|NCT00666562|"~     Green tea extract contains ingredients that may slow the growth of certain cancers. It is not~     yet known whether green tea extract is more effective than a placebo when given before~     surgery in treating patients with bladder. This randomized phase II trial is studying green~     tea extract to see how well it works compared to a placebo when given before surgery in~     treating patients with nonmetastatic bladder cancer.~   "
220963|NCT00666549|"~     This study that will allow for the preservation and/or storage of a small portion one or more~     of the following tissues:~        -  Peripheral blood~        -  Bone marrow~        -  Bone marrow biopsy~        -  A phlebotomized unit of blood~        -  Spleen cells~        -  Toenail clippings~      This material will be used for the study of Myeloproliferative Disorders (MPD) by~     researchers. The goals of this research study are to understand the causes of MPDs, how to~     diagnose them more easily and how to treat them better. MPD is a disease affecting~     hematopoietic stem cells. Hematopoietic stem cells are cells that make blood cells. These~     stem cells grow in the center portion of the bones called bone marrow. Under some conditions,~     these cells are also found in blood. There are several diseases, which are classified as MPD.~     These include polycythemia vera (too many red blood cells), essential thrombocythemia (too~     many platelets), and idiopathic myelofibrosis (abnormal blood cells and fibers build up in~     the bone marrow). These syndromes carry a high risk of developing leukemia. It is important~     to continue to learn more about these blood cancers and to learn more about the effectiveness~     and potential side effects of various treatments.~   "
220964|NCT00666536|"~     The purpose of this trial is to compare blood pressure lowering efficacy of moderate~     Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 /~     10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan~   "
220965|NCT00666523|"~     The objective of the study is to test the effects of a herbal supplement, Phytalgic, on the~     symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics~     on a regular basis.~   "
220966|NCT00666510|"~     Intraoperative bronchospasm challenges anesthesia's safety. This study aims to investigate~     high concentration of exhaled nitric oxide as a marker of intraoperative bronchospasm.~   "
220967|NCT00666497|"~     The purpose of the study is to determine how effective azacitidine, MGCD0103, and the~     combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of~     age.~   "
220968|NCT00666484|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. It is not yet known~     which regimen of combination chemotherapy is more effective for Hodgkin lymphoma.~      PURPOSE: This phase II trial is studying the side effects of three different regimens of~     combination chemotherapy and to see how well they work in treating younger patients with~     Hodgkin lymphoma.~   "
220969|NCT00666471|"~     Epistaxis is a common disorder with 60% of the population suffering from one episode and 10%~     of these cases requiring medical attention. Between March 2006 and March 2007, in Calgary,~     Alberta, there were 1500 presentations of epistaxis to adult emergency rooms with 7% of these~     (105 patients) requiring packing with admission. Common methods to control epistaxis include,~     nasal packing (88%), operative arterial ligation (10%), and arterial embolization (2%). A~     cost analysis demonstrated that nasal packing had a lower cost compared to embolization and~     arterial ligation, and all modalities had similar lengths of stay (Goddard, Otolaryng Head~     Neck Surg. 2006). Arterial ligation is the current recommended therapy for recurrent or~     refractory epistaxis, with a success rate of 98%. With the advancement of endoscopic~     techniques, emergency room Minimally Invasive Control of Epistaxis (M.I.C.E.) allows for~     selective packing and cauterization, which provides the patient with retained function of~     their nasal cavity and prevents a hospital admission, resulting in significant cost savings.~      Hypothesis:~      Does the M.I.C.E. procedure provide significant cost savings compared to operative~     sphenopalatine artery ligation? Null hypothesis is that there is no difference in hospital~     admission rates between M.I.C.E. and operative sphenopalatine artery ligation.~   "
220971|NCT00666445|"~     This study is designed to test the hypothesis that the Synchronous Neural Interaction™ Test~     is useful for diagnosing Probable Alzheimer's Disease according to standard criteria.~     Subjects diagnosed with Alzheimer's Disease as well as age-matched normal control subjects~     will be evaluated for symptoms of Alzheimer's Disease and those meeting inclusion criteria~     will undergo a brief, non-invasive scan of brain function using a magnetoencephalography~     (MEG). The scan itself lasts 1 minute while the subject is asked to stare at a dot projected~     in front of them on a video screen. Orasi Medical believes that patterns of brain activity~     measured at rest are indicative of Alzheimer's Disease pathology.~      The protocol is amended to add a follow-up assessment for previously enrolled and completed~     subjects who agree to participate in the follow-up assessment approximately 9 - 15 months~     after initial study enrollment. Subjects who agree to participate in the follow-up assessment~     will undergo the same standardized tests and MEG scan procedure as completed in the initial~     study.~   "
220972|NCT00666432|"~     Briefly, this multisite study is designed to identify endophenotypes (i.e., heritable~     biomarkers) associated with either schizophrenia or bipolar disorder alone, or both together.~     The subsequent genetic analyses will search genomic loci and candidate genes associated with~     each of the independent endophenotypes. This is a five site study that is slotted for NIMH~     funding.~   "
220973|NCT00666419|"~     A large study in Mallorca, Spain showed that nonspecific low back pain is quite prevalent in~     adolescents 13-15 years of age (Kovacs, 2003). Since below the age of seven years hardly any~     child has suffered low back pain, the purpose of this study is to determine the prevalence of~     low back pain in children 10-12 years of age, and to investigate the risk factors associated~     with its occurrence.~   "
220974|NCT00666406|"~     The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate~     rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe~     hemophilia A (factor VIII level < 1%).~   "
220975|NCT00666393|"~     The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40~     mcg system for the management of postoperative pain in pediatric inpatients.~   "
220976|NCT00666380|"~     The purpose of this study is to determine whether an investigational malaria vaccine is safe~     and induces an immune response against malaria when tested in adults living in the United~     States.~   "
220977|NCT00666367|"~     This project aims to explore the relationship between Vitamin D deficiency and COPD~     progression via a prospective randomized placebo-controlled study. For this purpose, study~     was powered to 120 patients hospitalized with an exacerbation of COPD randomly assigned to a~     monthly oral dose of Vitamin D versus placebo. Taking into account dropouts, 182 patients are~     randomized during the course of the study~   "
220978|NCT00666354|"~     The purpose of this clinical study is to compare the efficacy and safety of three~     concentrations of topical methotrexate for the treatment of fingernail psoriasis.~   "
220979|NCT00666341|"~     Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen~     (Phleum pratense)~   "
220980|NCT00666328|"~     The purpose of this study was to determine the efficacy and safety of clevidipine for~     treating acute hypertension (high blood pressure, defined as systolic blood pressure >160~     mmHg) in patients with intracerebral hemorrhage (i.e., bleeding in the brain; stroke).~   "
220981|NCT00666315|"~     New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among~     other things, ultrasound instruments have been used for the dissection, division and~     coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a~     clinically and economically significant reduction in operating time with no increase in the~     complication rate when the Harmonic device has been used. The aim of the present clinical~     trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed~     especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC~     in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the~     surgical site, amount of drainage, and complications, including the incidence of RLN palsy~     and hypoparathyroidism.~   "
220982|NCT00666302|"~     A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients~     with Atopic Dermatitis~   "
220983|NCT00666289|"~     Myeloproliferative disorders occur in families, thus giving rise to the theory that it is a~     genetic disease that may be caused by an abnormal gene in the DNA that can be passed from one~     generation of family members to another. DNA can be gathered from family members through~     blood samples and the investigators will investigate (through DNA testing) to see if there~     are abnormal genes that may be responsible for causing the MPDs. Understanding which genes~     are responsible for causing MPDs can help develop ways to identify people who may be at risk~     for developing an MPD, allow for the development of better treatments, possibly a cure, or~     even prevent the development of MPDs.~   "
220984|NCT00666276|"~     Drug use investigation of Zyvox for patients with Methicillin-resistant Staphylococcus aureus~     (MRSA) infection disease.~      The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of~     adverse drug reactions in this surveillance, and 3)factors considered to affect the safety~     and/or efficacy of this drug.~   "
220985|NCT00666263|"~     The purpose of the study is to evaluate the efficacy (effect on grip strength and disability)~     and safety/tolerability of IGIV, 10% in subjects with Multifocal Motor Neuropathy.~   "
220986|NCT00666250|"~     An antioxidant dietary supplement made from cocoa powder, and extracts of acai, grape and~     blueberry will be tested for effects on blood sugar, blood pressure, cholesterol and related~     parameters in human subjects.~   "
220987|NCT00666237|"~     The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the~     long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with~     mitomycin C in eyes that have not had previous ocular surgery.~   "
221044|NCT00665496|"~     This purpose of the study was to evaluate the earliest time to onset of action in adults with~     erectile dysfunction (often called impotence). In this study vardenafil has been compared to~     placebo. Patients were asked to fill in questionnaires and a diary in which they filled in~     details about attempts at sexual activity during study period. Patients received also a~     stopwatch to record the time of onset of erection. Stopwatch should be started immediately~     prior to initiating sexual activity and stopped when an erection perceived to be adequate for~     penetration was obtained.~   "
220988|NCT00666224|"~     The primary objective is to assess the effect of treatment with glatiramer acetate (GA)~     compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the~     occurrence of the second clinical attack) during the double-blind period. The secondary~     objective is to assess, within the time frame of the up to 3-year double-blind,~     placebo-controlled study period, the effect of GA on clinical and Magnetic Resonance Imaging~     (MRI) parameters. The long-term objectives of the study (exploratory in nature) are to~     assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed~     treatment with GA as reflected by clinical and MRI parameters measuring the accumulated~     irreversible brain tissue damage.~      A pre-planned interim analysis was performed on all efficacy and safety data accumulated in~     the database up to October 14, 2007, i.e. when 81% of exposure to treatment in the~     double-blind, placebo-controlled period had been collected. Upon review of the interim~     analysis results, the Data Monitoring Committee (DMC) recommended that the double-blind~     portion of the study be stopped and that subjects be switched to the 2-year Open-label~     period, during which time they would have the option of receiving GA therapy. The sponsor~     (Teva) adopted the DMC recommendations and took the necessary action towards its~     implementation.~   "
220989|NCT00666211|"~     RATIONALE: An Opioid Titration Order Sheet that allows healthcare providers to adjust the~     dose and schedule of pain medication may help improve pain treatment for patients with~     cancer. It is not yet known whether the use of an Opioid Titration Order Sheet is more~     effective than standard care in treating pain caused by cancer.~      PURPOSE: This randomized phase III trial is studying an Opioid Titration Order Sheet to see~     how well it works compared with standard care in treating patients with cancer pain.~   "
220990|NCT00666198|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
220991|NCT00666185|"~     To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment~     of patients with Esophageal Candidiasis~   "
220992|NCT00666172|"~     Employees in developed societies are becoming increasingly sedentary at work and at home due~     to technological advances. Physical inactivity coupled with excess intake of calorie-rich~     foods are responsible for the epidemic of obesity. In population cohorts, physical inactivity~     and obesity increase the risk of cardiovascular disease and death. Because of the impact on~     productivity and health care costs, many businesses and other organizations have initiated~     wellness programs, often with facilities at the work site to encourage exercise. Although~     these programs have often resulted in improved fitness for participants, weight loss has been~     more difficult to achieve. In this regard, in our initial study of NIH employees~     participating in NHLBI's Keep the Beat program--two-thirds of whom were overweight or~     obese--we found improved exercise fitness after 3 months of participation, with exercise~     averaging 20 minutes each work day, but no significant weight loss. Associated with greater~     fitness in our participants was improvement in endothelial function, an important biomarker~     of cardiovascular risk. Because level of fitness is a strong predictor of cardiovascular (and~     total) mortality in population studies, some investigators and thought leaders have proposed~     that it is acceptable to be fat and fit. We found in our study, however, that exercise~     alone has little effect on insulin sensitivity and other biomarkers of risk, including~     C-reactive protein, which could limit further improvement in endothelial function and even~     greater risk reduction. We propose to test in this protocol whether weight loss through~     supervised nutritional counseling and daily exercise at worksite facilities confers health~     benefits beyond those achieved with improved fitness alone, such as improvement in~     endothelial function, arterial compliance, insulin sensitivity, markers of inflammation in~     blood and high-density lipoprotein (HDL) structure and function. Because obesity in a~     sedentary workforce environment is especially prevalent among women, with additional~     contribution of menopause to obesity, our study will be restricted to overweight and obese~     women to allow appropriate analysis in a cohort of manageable size for our testing resources.~     The primary endpoint will be differential improvement in endothelial function, as determined~     by brachial artery reactivity to shear stress, from baseline to 6 months in participants~     randomized to exercise coupled with weight-loss intervention versus subjects randomized to~     exercise alone. Secondary analyses will include comparisons of adiposity, arterial stiffness,~     insulin sensitivity, HDL subparticles and function, and markers of inflammation and~     adipokines in blood, with exploratory analyses of minorities and age/hormonal interactions.~     Demonstration of improved vascular function and other biomarkers of cardiovascular risk with~     improved fitness combined with weight loss may serve as an incentive for greater~     participation in organization-initiated wellness programs with emphasis both on exercise and~     on personalized nutritional counseling....~   "
220993|NCT00666159|"~     Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in~     pediatric patients with Atopic Dermatitis~   "
220994|NCT00666146|"~     We propose to recruit 150 case families (i.e., families with a schizophrenia proband), 150~     control families, and 45 control subjects who exhibit schizophrenia spectrum personality~     symptoms in the absence of a family history of schizophrenia. Participants will undergo a~     number of clinical, electrophysiological, perceptual, and cognitive assessments. These data~     will be used to identify phenotypes likely to be associated with genetic risk for~     schizophrenia, and to determine how these phenotypes aggregate in families. Some of the~     analyses will focus on examining associations between candidate genes and these alternative~     phenotypes. Thus if we are not able to recruit relatives we may still collect these~     phenotypic data in probands and their genetic sample for future genotype/phenotype~     association studies. Testing procedures require a 10-12 hour time commitment and testing will~     be completed over 2 or more days. Participants will be asked to give a blood (or saliva if~     difficult to obtain blood sample for instance because of fear of blood draws), which will be~     stored for future genetic analyses.~   "
220995|NCT00666133|"~     Preeclampsia is a condition unique to pregnancy characterized by the new onset of~     hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious~     complication increasing the risk of maternal and infant mortality and morbidity. Magnesium~     sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia~     and eclampsia.~      Magnesium sulfate is administered parenterally by intramuscular (IM) or intravenous routes~     (IV). In general a loading dose of 4 to 5 grams of magnesium sulfate is administered~     intravenously followed by an IM injection every 4 hours or by a continuous IV infusion. The~     IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion~     pump for safe delivery and has a greater potential for inadvertent overdose. Although~     magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and~     prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug~     remain. The IM dosing regimen, while potentially safer, requires repeated painful IM~     injections. These limitations in administration hinder the widespread use of magnesium~     sulfate despite its demonstrated benefits.~      The goal of this research is to develop a system of care that avoids overdose and facilitates~     the use of magnesium sulfate for the treatment of preeclampsia. To this end, a primary~     objective of this research is to demonstrate the safety of a simple, inexpensive flow~     controlled pump system (Springfusor®). This randomized study will compare the administration~     of magnesium sulfate by the Springfusor® controlled pump with an IM regimen, the standard of~     care in most hospitals in India. The study will document the efficacy and acceptability of~     each treatment for patients and staff and compare the cost and time elements involved in~     providing each method.~   "
220996|NCT00666120|"~     To compare the number of infants who discontinue from study formula due to formula~     intolerance as documented by the investigator.~      Hypothesize there will be no difference between formula groups.~   "
220997|NCT00666107|"~     This study will investigate the efficacy and safety of the quadrivalent vaccine (Gardasil)~     against the human papilloma virus (HPV) in HIV (human immunodeficiency virus) infected males.~   "
220998|NCT00666094|"~     To test the hypothesis that there is no difference in change in HbA1C among men with type~     2-diabetes after an exercise intervention with strength versus endurance training.~   "
220999|NCT00666081|"~     This is a two-part study in subjects with hematologic malignancies designed to find the~     maximum tolerated dose (MTD) of GSK690693 (Part 1). Part 2 is designed to determine the~     efficacy of GSK690693 in a subset of subjects with hematologic malignancies.~   "
221000|NCT00666068|"~     In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine~     responses when hormones are injected. This is at least true for those with a complete~     insufficiency of the anterior pituitary. For example, administration of corticotropin~     releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore,~     pure hormone effects can be investigated.~      It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved~     in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was~     reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was~     therefore to study the effect of CRH on patients with hypopituitarism.~      To date, there is no information on sleep of patients with hypopituitarism. Secondary~     objective is therefore to compare sleep of patients with hypopituitarism with sleep of~     age-matched healthy controls.~   "
221045|NCT00665483|"~     Multicenter Skin Prick Test~   "
221565|NCT00658671|"~     A dose-escalation trial designed to assess the safety and tolerability of treatment with~     ENMD-2076 administered orally over a range of doses in patients with advanced cancer that is~     refractory to current treatment or for which no curative therapy exists.~   "
221001|NCT00666055|"~     The purpose of this research study is to learn about levels of antiretroviral drug levels and~     response to HIV virus in the genital tract of women who are post-menopausal. The~     investigators in this study think that the levels of hormones post-menopausal HIV-infected~     women may have in their bodies may affect the levels of antiretroviral drug, and therefore~     affect how much HIV virus they have in their bodies. Since women who have already gone~     through menopause have different levels of hormones, such as estrogen, than women who are~     pre-menopausal, the investigators would like to check the levels of antiretroviral drugs in~     their blood, their genital secretions, and their genital tissue.~   "
221002|NCT00666042|"~     The study compares the amounts of Vigamox absorbed when administered as eye drops or in a~     spray form. Both administrations will be prior to patients undergoing elective cataract~     surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The~     hypothesis is that there will be no difference between the 2 modes of administration.~   "
221003|NCT00666029|"~     To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial~     to determine whether treatment with a statin improves muscle microvascular blood flow.~   "
221004|NCT00666016|"~     The purpose of this study is to assess the safety, the tolerability and the short term effect~     on liver enzymes of TRO19622 500 mg for one month in patients with Non-Alcoholic~     Steatohepatitis (NASH).~   "
221005|NCT00666003|"~     Fluid and volume management are a challenging part of critical care and the difficulties~     increase in the face of renal failure. Utilizing the Crit-Line to monitor blood volume~     changes in conjunction with arterial pressure cardiac output monitoring may lead to better~     understanding of the impact fluid removal during dialysis has on hemodynamics.~   "
221006|NCT00665990|"~     Phase I Study of Bevacizumab and Sorafenib Combined with Low Dose Cyclophosphamide in~     Patients with Refractory Solid Tumors and Leukemia. Patients with solid tumors (including~     central nervous tumors) that are recurrent or refractory to standard therapy, or for whom~     standard therapy is not available. Once a maximum tolerated dose (MTD) has been established~     in patients with recurrent or refractory solid tumors, the tolerability of this dose will be~     tested in patients with refractory or recurrent leukemia and an expanded cohort of patients~     with refractory or recurrent solid tumors.~   "
221007|NCT00665977|"~     1. CPAP compliance will be significantly higher in both the heated humidity with~          Thermosmart™ and the nasal steroid phases compared to the double placebo phase.~        2. CPAP compliance will be comparably improved in the heated humidity with Thermosmart™~          phase versus the nasal steroid phase.~        3. Improvement in nasal symptoms in using CPAP will be significantly improved in both the~          heated humidity with Thermosmart™ and the nasal steroid phases compared to the double~          placebo phase, and comparable between the heated humidity with Thermosmart™ phase versus~          the nasal steroid phase.~        4. Secondary to improvements in CPAP compliance, measures of daytime functioning and~          quality of life will improve in the heated humidity with Thermosmart™ versus double~          placebo.~   "
221008|NCT00665964|"~     Methodology: This study will be a randomized, multi-center evaluation comparing N2vac~     polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS~     total knee system.~      Study Duration: 12-18 month enrollment period + 10 year follow-up for each case years total~     duration~      Multi-centre study~      Objectives~      Primary: To compare the 10 year implant survival of the Triathlon PS total knee system when~     X3 polyethylene components are used to the same knee system when N2Vac components are used.~      Secondary: To compare pain, function, radiographic outcomes, and health related quality of~     life of subjects in both treatment groups. Safety will be assessed by comparison of adverse~     events between the groups.~      Number of Subjects 384 cases (197 each group)~   "
221009|NCT00665951|"~     This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in~     pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded~     formulation. The formal bioequivalence study with adequate power will be conducted by the~     manufacturer. In order to get data independently from the manufacturer and to have this~     information in an earlier phase, this small pilot study is initiated.~      The initial study showed a declined bioavailability of the granules under fasting conditions.~     The study has been extended with an arm determining the pharmacokinetics of the granules~     after food (compared to the oral solution taken with food).~   "
221010|NCT00665938|"~     The purpose of this study is to compare physical development of infants fed one of three~     study formulas.~   "
221011|NCT00665925|"~     The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor,~     R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally,~     once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an~     inadequate clinical response to methotrexate.~   "
221012|NCT00665912|"~     The purpose of this study is to determine whether the use of platelet-rich plasma (PRP) and~     concentrated platelet-poor plasma (PPPc) can reduce the duration of post-operative air leak~     after lobectomy for lung tumours.~   "
221013|NCT00665899|"~     The purpose of the proposed study is to evaluate the efficacy of a new couple-based~     intervention for women with recently diagnosed, early stage breast cancer and their spouses~     or male partners. This cancer-focused relationship enhancement intervention adapts~     well-validated cognitive-behavioral interventions to teach patients and partners specific~     relationship skills, such as problem-solving skills, communication, and maximizing positive~     interactions, that they can use in addressing breast cancer. This project's major goals are~     to improve the patient's individual functioning and specific aspects of the couple's~     relationship affected by breast cancer (e.g., mood, role functioning, sexual functioning, and~     social support). In the current investigation, cancer-focused relationship enhancement will~     be compared to (a) a couple-based Cancer Education intervention and (b) a Treatment-as-Usual~     condition.~   "
221014|NCT00665886|"~     The purpose of this study is to investigate, in a prospective and randomized fashion, the~     clinical performance of a closed intravenous system versus an open conventional one, with~     respect to ease of handling and effectiveness (as defined by time of survival without~     complications), security provided to professionals and patients against accidental blood~     exposure or needlestick injury, catheter-related complications such as phlebitis, pain and~     blockage and overall costs of the two systems.~   "
221015|NCT00665873|"~     BACKGROUND: The growing use of totally implantable venous access devices (TIVAD) has caused~     the simultaneous increase of various complications. The infection of the TIVAD or the~     subcutaneous pocket in which the device is positioned is one of the most encountered~     complications. The aim of this study is to evaluate the role of the antibiotic in the~     prevention of the infection of the surgical site and the TIVAD until 30 days after the~     implant.~      METHODS: The authors enrolled one hundred consecutive patients divided into two randomized~     arms: group A (antibiotic), group B (no antibiotic), each of 50 patients. All the patients~     were affected by solid tumors needing chemotherapy continuously. TIVADs were implanted~     surgically in cephalic vein. Signs or symptoms considered were: pain, localized swelling,~     redness, and heat. White cell count was considered on the first, third, and seventh~     postoperative days, and the tests were made in the in-hospital laboratory. Body temperatures~     were checked twice daily for 7 days.~   "
221016|NCT00665860|"~     The purpose of this study is to determine whether soy isoflavone supplementation is safe and~     effective to prevent bone loss in postmenopausal women.~   "
221017|NCT00665847|"~     The purpose of this study is to determine the safety and antiviral activity of etravirine in~     treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.~   "
221018|NCT00665834|"~     This is a 3-month, randomized, parallel-group study with 2 periods, comparing the efficacy~     and the safety of rosuvastatin 20 mg versus atorvastatin 80 mg in patients with an acute~     coronary syndrome (ACS).~   "
221019|NCT00665821|"~     The purpose of this study is to assess the effect of two different types of health education~     programs on the disability, beliefs related to low back pain and duration of sick leave in~     patients seen at a workers' health care organization~   "
221020|NCT00665808|"~     This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON~     INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when~     using Levemir® versus Protaphane® in combination with OADs in daily settings.~   "
221021|NCT00665795|"~     The purpose of this protocol is to study orbital structures in Graves´ Disease using~     multidetector computed tomography and color doppler imaging.~      Some changes in orbital structures detected by imaging exams could predict severity of the~     ocular Graves´disease. Thus the study could be useful in improve medical management of~     patients with Graves´ Disease.~   "
221022|NCT00665782|"~     RATIONALE: Gathering information about how patients respond to stress and measuring stress~     levels in women with newly diagnosed breast cancer may help doctors provide better methods of~     treatment and on-going care.~      PURPOSE: This research study is measuring stress in women with newly diagnosed stage I, stage~     II, or stage III breast cancer or ductal carcinoma in situ of the breast.~   "
221023|NCT00665769|"~     Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in~     the US survive with severe bleeding in the brain (intraventricular hemorrhage); this~     devastating complication of prematurity is associated with many problems, including mental~     retardation, cerebral palsy, and learning disabilities, that result in profound individual~     and familial consequences. In addition, lifetime care costs for these severely affected~     infants born in a single year exceed $3 billion. The huge individual and societal costs~     underscore the need for developing care strategies that may limit severe bleeding in the~     brain of these tiny infants. The overall goal of our research is to evaluate disturbances of~     brain blood flow in these tiny infants in order to predict which of them are at highest risk~     and to develop better intensive care techniques that will limit severe brain injury.~        1. Since most of these infants require ventilators (respirators) to survive, we will~          investigate how 2 different methods of ventilation affect brain injury. We believe that~          a new method of ventilation, allowing normal carbon dioxide levels, will normalize brain~          blood flow and lead to less bleeding in the brain.~        2. We will also examine how treatment for low blood pressure in these infants may be~          associated with brain injury. We believe that most very premature infants with low blood~          pressure actually do worse if they are treated. We think that by allowing the infants to~          normalize blood pressure on their own will allow them to stabilize blood flow to the~          brain leading to less intraventricular hemorrhage.~        3. In 10 premature infants with severe brain bleeding, we have developed a simple technique~          to identify intraventricular hemorrhage before it happens. Apparently, the heart rate of~          infants who eventually develop severe intraventricular hemorrhage is less variable than~          infants who do not develop this. We plan to test this method in a large group of~          infants, to be able to predict which infants are at highest risk of developing~          intraventricular hemorrhage and who could most benefit from interventions that would~          reduce disturbances of brain blood flow.~   "
221024|NCT00665756|"~     In the management of open angle glaucoma, frequently more then one procedure is necessary to~     control the intra ocular pressure. There is still no consensus whether this second~     intervention should be a second trabeculectomy or a shunt device. In the present study we~     compare a second trabeculectomy versus Ahmed silicone shunt device in open angle glaucoma~     patients with previous trabeculectomy without proper IOP control.~   "
221025|NCT00665743|"~     We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent~     formulations.~   "
221026|NCT00665730|"~     This study will examine the safety and efficacy of Sepraspray in the following model of~     abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via~     laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be~     evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate~     this study in June 2008 due to low enrollment.~   "
221027|NCT00665717|"~     The purpose of this trial is to determine the effect of raltegravir on pravastatin~     pharmacokinetics and vice versa by intrasubject comparison.~   "
221028|NCT00665704|"~     The purpose of this study is to develop an evidence-based Tobacco Tactics website tailored to~     veterans based on an intervention tested in the VA.~   "
221029|NCT00665691|"~     Researchers are studying ways to predict if cancer patients are at risk for poor nutrition~     during their chemotherapy treatment. They hope to identify children with nutrition problems~     early in treatment. This may help prevent weight loss and other nutrition problems later in~     treatment.~   "
221079|NCT00665028|"~     After surgery, patients who have cardiogram changes consistent with a lack of oxygen to the~     heart muscles, also known as myocardial ischemia, have been found to have 9 times the chance~     of having an event such as a heart attack during the subsequent 30 days. It is not known if~     monitoring and treating ischemia will prevent events such as heart attacks. It is not known~     if such monitoring and treatment can be done on the regular surgical wards. In this pilot~     study, we hope to demonstrate that such a study is feasible, and the maintenance of blinding~     is possible. The primary outcomes are to show that such monitoring after surgery is possible~     in ≥ 95% of patients, to show that response and treatment to such ischemia in ≤ 1 hour is~     possible in ≥ 90% of patients, and that blinding between the standard and active treatment~     groups is possible for 50% ± 1 s.d.. With the pilot study data, if successful, we will be~     applying for peer-reviewed funding for a full study.~   "
221030|NCT00665678|"~     Background: Innovation: Over 150,000 soldiers are currently deployed in Iraq as part of~     Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress~     disorder (PTSD). Research from our group and others showed lasting neurobiological~     consequences of PTSD, including increased amygdala function and decreased medial prefrontal~     function, verbal declarative memory problems, and smaller hippocampal volume that reverses~     with treatment with the serotonin reuptake inhibitor (SSRI) paroxetine or the anticonvulsant~     phenytoin. Recently we found that three months of treatment with paroxetine in PTSD patients~     resulted in an increase in hippocampal N-acetyl-aspartate (NAA), a marker of neuronal~     integrity, as well as decreased brain metabolism in the amygdala and a reversal or stress~     induced decreases in medial prefrontal function. Subjects treated with placebo did not have~     an increase in NAA, however subsequent treatment for three months with open label paroxetine~     resulted in an increase in NAA to the level seen in the subjects treated with paroxetine in~     the double-blind phase. Paroxetine was associated with a decrease in amygdala metabolism~     measured with positron emission tomography (PET) and increased medial prefrontal function.~     Intervening soon after the trauma is critical for long-term outcomes, since with time~     traumatic memories become indelible and resistant to treatment. Diminished efficacy of~     treatment over time is shown by the fact that trials of Vietnam veterans have shown less~     efficacy over the years. Animal studies show that pretreatment before stress with~     antidepressants reduces chronic behavioral deficits related to stress; although for ethical~     and other reasons no studies have provided pretreatment before trauma exposure in humans. In~     our current VA Merit funded program we are looking at the effects of early interventions for~     Iraq soldiers with paroxetine, looking at chronicity of PTSD, cognition, cortisol response to~     stress, hippocampal volume and NAA, as outcomes. We now propose to add measurement of neural~     correlates of paroxetine response using PET.~      Objectives/Hypotheses: The objectives of this research are to:~        -  Assess the efficacy of paroxetine versus placebo in the treatment of early PTSD in OIF~          veterans~        -  Assess the effects of paroxetine versus placebo on amygdala metabolism and medial~          prefrontal response to stress in OIF veterans with PTSD.~        -  Assess the ability of brain imaging to predict treatment response and to identify~          veterans with early PTSD who will benefit from early interventions.~      Hypotheses are that paroxetine will be associated with: 1) an improvement in PTSD symptoms~     compared to placebo based on the change in the CAPS from baseline to three months of~     treatment in veterans of OIF; 2) increased medial prefrontal function and decreased amygdala~     metabolism in veterans of OIF.~      Specific Aims:~        -  Compare paroxetine to placebo in the treatment of early PTSD in OIF veterans~        -  Measure amygdala metabolism and medial prefrontal response to stress with PET in OIF~          veterans with PTSD before and after paroxetine or placebo treatment.~   "
221031|NCT00665665|"~     This trial will be conducted in the United States of America (USA). The aim of the trial is~     to investigate whether the drug is safe, well tolerated and to investigate the efficacy of~     NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and~     placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase~     1 part of trial conducted between November 2007 and April 2008).~   "
221032|NCT00665652|"~     The purpose of the study is to learn about the effects of the drug, lenalidomide (Revlimid®),~     on neuropathy (damage to the nerves that affect feelings and strength) associated with~     Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS).~   "
221033|NCT00665639|"~     To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin~     for the treatment of esophageal candidiasis~   "
221034|NCT00665626|"~     The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor,~     R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment~     of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.~   "
221035|NCT00665613|"~     The purpose of this study is to determine if osteoporosis is an unrecognized complication of~     chronic anticoagulation with warfarin.~   "
221036|NCT00665600|"~     To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of~     treatment in COPD.~   "
221037|NCT00665587|"~     Aim of the project is to assess the long-time clinical impact of surgical ablation (MAZE~     procedure) on patients who suffer from atrial fibrillation but are indicated to a cardiac~     surgery for other predominant cardiac diagnosis (heart valve surgery, coronary~     revascularization or combined surgery). In recent years, those patients are more and more~     frequently indicated to some type of MAZE procedure, without the real benefit of this~     procedure for patients has been assessed with an enough large, randomized study. Even though~     it is well known, that MAZE procedures declines the early postoperative incidence of atrial~     fibrillation, convincing data about its mid-term and long-term impact on patients and about~     the appearance of recidives of atrial fibrillation in long-time horizon are still missing.~     Our hypothesis assumes, that MAZE procedure will significantly decrease the appearance of~     atrial fibrillation one year after the operation, without increasing mortality or incidence~     of serious postoperative complications in thirty postoperative days.~   "
221038|NCT00665574|"~     To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and~     ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients~     who have failed to respond adequately to conservative non-pharmacologic therapy and simple~     analgesics~   "
221039|NCT00665561|"~     The study will assess if use of maraviroc along with an optimized background regimen of~     antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen~     of antiretroviral drugs.~   "
221040|NCT00665548|"~     The purpose of the study is to use different x-ray and magnetic resonance (MR) imaging~     techniques to take pictures of the knee. There are two specific purposes to the study:~        1. whether the different x-ray and MRI techniques will give the same or different~          information about the knee joint and~        2. which part of the knee joint will show the biggest change using the different x-ray and~          MRI techniques. The study is not designed to test a hypothesis.~   "
221041|NCT00665535|"~     The purpose of the study is to determine the optimal frequency of repositioning nursing~     facility residents with limited mobility who are cared for on a high density foam mattress in~     order to prevent bed sores. It is hypothesized that participants at moderate risk (Braden~     Scale Scores 13-14) who are turned every 3 or 4 hours and participants at high risk (Braden~     Scores 10-12) turned every 3 or 4 hours will not have a higher incidence of ulcers than those~     residents turned every 2 hours.~   "
221042|NCT00665522|"~     The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine~     conditions and obtain a more comprehensive understanding of the safety of the system and~     complications that may not be spontaneously reported.~   "
221043|NCT00665509|"~     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in~     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of~     these vaccines are required to be involved in ongoing clinical trials and to present the~     results to the competent authorities each year. The current study is a phase IIIa clinical~     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It~     is part of the ongoing clinical trial program for Influvac® and will be done to assess the~     immunogenicity and safety and tolerability of next season's trivalent influenza subunit~     vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects~     >= 61 years of age (elderly).~   "
221080|NCT00665015|"~     Pleural effusion is a common complication of cardiac surgery. The aim of this study was to~     determine the prevalence, characteristics and determinants of clinically significant pleural~     effusions, defined as those requiring therapeutic pleural drainage.~   "
221046|NCT00665470|"~     Background:~      This study uses a new experimental procedure for treating melanoma that uses the patient's~     own lymphocytes (type of white blood cell), which are specially selected to target and~     destroy their tumor.~      Objectives:~      To determine whether this experimental treatment can cause the patient's tumor to shrink.~      To test the safety of the treatment and its effects on the immune system.~      Eligibility:~      Patients with metastatic melanoma 18 years of age and older for whom standard treatments are~     not effective or who cannot take high-dose interleukin-2 (IL-2).~      Patients must have the tissue type human leukocyte antigens (HLA-A)0201.~      Design:~      Workup: Patients have scans, x-rays, laboratory tests, and other tests as needed.~      Patients have leukapheresis (a procedure for collecting lymphocytes that is similar to~     collecting whole blood) to collect cells for laboratory treatment and later reinfusion.~      Chemotherapy: Patients have low-dose chemotherapy for 1 week to prepare the immune system to~     receive the cultured lymphocytes.~      Cell infusion and IL-2 treatment: Patients receive the lymphocytes by infusion through a vein~     and then either high-dose IL-2 infused through a vein or low-dose IL-2 injected under the~     skin. High-dose IL-2 is given as infusions through a vein every 8 hours for up to 15 doses.~     Low-dose IL-2 is given as injections under the skin daily for 5 days, followed by a 2-day~     rest, with this regimen repeated for a total of 5 weeks.~      Recovery: Patients rest for 1 to 2 weeks to recover from the effects of chemotherapy and~     IL-2.~      Tumor biopsy: Patients may be asked to have a biopsy (removal of a small piece of tumor)~     after receiving treatment to look at the effects of treatment in the tumor.~      Follow-up: After treatment is completed, patients return to the clinic for physical~     examinations, review of side effects, laboratory tests and scans every 1 to 6 months until~     the disease worsens.~      Retreatment: Patients whose tumor did not grow after treatment or showed evidence of~     shrinking may be able to be retreated if their tumor begins to grow. They receive the same~     regimen of chemotherapy, lymphocyte infusion and IL-2 treatment....~   "
221047|NCT00665457|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This phase II clinical trial is studying biomarkers and side effects in women~     receiving chemotherapy and celecoxib for stage II or stage III breast cancer that can be~     removed by surgery.~   "
221048|NCT00665444|"~     The proposed study is a non-randomized, open label trial that will examine the potential to~     reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and~     functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention~     of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided~     in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in~     duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet~     with their study psychiatrist at least bi-monthly throughout their participation, more~     frequently when clinically necessary (e.g. during medication tapering or if manic/depressive~     symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough~     assessments will be conducted at Baseline, Week 2, and Month 3.~   "
221049|NCT00665431|"~     We will evaluate the efficacy of PN 400 and an active comparator in patients that have~     Osteoarthritis of the knee.~   "
221050|NCT00665418|"~     To describe laryngeal and respiratory reflex responses after controlled laryngeal stimulation~     in pediatric patients anesthetized with sevoflurane and to compare the evoked responses at~     two levels of anesthesia. To determine whether laryngeal and respiratory reflex responses~     after controlled laryngeal stimulation are completely suppressed in subjects when~     anesthetized with a MACEI95 (EI = endotracheal intubation) sevoflurane Hypothesis: The~     incidence of apnea with laryngospasm evoked by laryngeal stimulation will be reduced by 20%~     (from 25% to 5%) when the end-tidal concentration of sevoflurane is increased from 2.5%~     (MAC50) to 4.7% (MACEI95)~   "
221051|NCT00665405|"~     Pregnancy promotes respiratory system's restrictive component. This study observes the~     generation of atelectasis during labor.~   "
221052|NCT00665392|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) together with cetuximab may kill more tumor cells.~      PURPOSE: This phase II clinical trial is studying how well cetuximab given together with~     combination chemotherapy works in treating patients with stage III or stage IV oropharynx~     cancer that can be removed by surgery.~   "
221053|NCT00665379|"~     The purpose of this trial is to study the effect of the 3M Coban 2 Layer Compression System~     (hereafter C2L) in the treatment of leg lymphedema compared to the traditional treatment with~     Trico bandages.~   "
221054|NCT00665366|"~     The purpose of the study is to determine whether aripiprazole provides additional clinical~     benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12~     weeks.~   "
221055|NCT00665353|"~     Insulin resistance is common in people coinfected with HIV and Hepatitis C virus (HCV) and is~     associated with poor responses to treatment for HCV. Pioglitazone is an FDA-approved~     medication for the treatment of type 2 diabetes. It works by increasing the body's~     sensitivity to insulin. The purpose of this study is to determine whether treatment with~     pioglitazone prior to HCV treatment with peginterferon and ribavirin is safe and effective in~     improving the treatment outcome in insulin-resistant, HIV/HCV-coinfected people for whom~     previous treatment with peginterferon and ribavirin was unsuccessful.~   "
221056|NCT00665340|"~     This study was conducted to evaluate in adult men with erectile dysfunction (often called~     impotence), the effect of vardenafil HCl on the quality of their erections. Many men~     experience occasional erectile problems during their lives. The causes of erectile~     dysfunction are varied and may be due to physiological or emotional reasons. This study is~     designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl.~     In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like~     the real drug but it is not. It contains no active ingredients.~   "
221057|NCT00665327|"~     This study was to assess the safety of sequential intravenous (IV)/oral (PO) moxifloxacin~     (Avelox®) compared with sequential IV/PO levofloxacin (Levaquin®) in the treatment of elderly~     subjects (aged &#8805; 65 years) with community-acquired pneumonia (CAP) who required initial~     IV therapy. This study also included an assessment of the clinical and bacteriologic~     effectiveness of both drugs.~   "
221081|NCT00665002|"~     The purpose of this study is to determine whether the WT-1 vaccine causes an immune response~     and is safe. The WT-1 vaccine is made up of protein pieces that the patient's immune system~     can recognize as abnormal.~   "
221082|NCT00664989|"~     Hypothesis: What is the difference in disease specific quality of life between patients who~     receive a humeral surface replacement hemiarthroplasty verusu a conventioanl stemmed~     hemiarthroplasty~   "
254830|NCT00215410|"~     The purpose of this study is to determine the most safe and effective dose of the~     investigational drug in comparison with a control drug and placebo.~   "
221058|NCT00665314|"~     Some patients with multiple myeloma or lymphoma will need treatment with high dose~     chemotherapy to treat their condition. This potent treatment will kill many of the~     blood-forming cells in the bone marrow. The patient will therefore need these blood-forming~     cells replaced after the chemotherapy treatment. This is done by collecting some of teh~     patients own blood-forming stem cells before chemotherapy, storing them and then infusing~     them into the patient after chemotherapy (in the same way as a blood transfusion is given).~     The stem cells will then make their way unto the bone marrow and re-populate it. Having stem~     cells collected and returned later is called an Autologous Transplant.~      In most patients these blood-forming stem cells (which normally live in the bone marrow) are~     mobilized into the blood stream where they are then collected by a process called apheresis~     (a bit like donating blood). This process of mobilization is not always successful. In this~     study patients who did not collect enough stem cells in a previous cell collection attempt to~     have an autologous stem cell transplant will participate. Patients will be mobilized with~     G-CSF (current standard treatment to mobilize stem cells) and the effect of adding AMD3100 to~     G-CSF will be studied by comparing outcomes in patients who get G-CDF with placebo~     (non-active substance which looks like AMD3100) to patients who get G-CSF with AMD3100.~      AMD3100 is a member of a new class of medications called chemokine inhibitors. The drug~     triggers the movement of stem cells out of the bone marrow into the blood stream. In previous~     studies with healthy volunteers and cancer patients, when AMD3100 and G-CSF were used in~     combination, a greater number of stem cells were mobilized into the blood stream than by~     using g-CSF alone.~      The purposes of this study are to measure how many stem cells can be collected, the number of~     days to collect those cells and the safety of a mobilization regimen of AMD3100 with G-CSF~     compared to G-CSF with placebo. If enough cells are collected to have a transplant, the study~     will also evaluate how well the cells grow when transplanted.~   "
221059|NCT00665301|"~     The purpose of this study is to compare cardiac output results obtained using the~     thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted~     cardiac output results obtained from the non-invasive FloWave™ 1000 device.~   "
221060|NCT00665288|"~     The goal of this study is to conduct a survey to better understand the factors associated~     with undertaking cardiopulmonary resuscitation (CPR) training and performing CPR in an~     emergency situation.~   "
221061|NCT00665275|"~     This is an observational study aiming to study the use of complementary and alternative~     medicine (CAM) drugs and methods among patients with inflammatory rheumatic diseases, at~     Rheumatology clinics in western Sweden and also to investigate possible associations between~     CAM using habits and other characteristics of the patients.~   "
221062|NCT00665262|"~     Ten patients 70 years and older having elective total hip/knee replacement surgery will be~     recruited to receive a continuous IV infusion of naloxone and oral tramacet for analgesia.~     Postoperative analgesia, satisfaction, side effects, need for rescure analgesia, and length~     of stay.~   "
221063|NCT00665249|"~     The purpose of this pilot study is to investigate the critical components of motivational~     interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic~     drinking. The study will disaggregate MI into its component parts and test full MI compared~     to MI without its directive strategies. This study will test whether the directive elements~     of MI are critical or whether MI effects may be attributable solely to its Rogerian,~     non-directive components. For more information, go to www.projectmotion.org~   "
221064|NCT00665236|"~     Treatment of migraine continues to be a major health problem today, despite many new~     pharmacological therapies. Limited clinical experience suggests that craniosacral therapy~     (CST) may be effective in the treatment of headache, including migraine. The primary aim of~     this proposal is to gather quality preliminary data on the usefulness of CST as an adjunct to~     conventional care for patients with migraine and to determine the feasibility of a larger,~     randomized clinical trial of CST in patients with migraine. Craniosacral therapists use a~     technique of gentle palpation of the head, neck and spine to release restrictions in cranial~     and peri-spinal tissues that are believed to contribute to a variety of health problems~     including headache. It is estimated that more than 2 million visits to CST practitioners are~     made each year, with more than 10 per cent of those for the complaint of headache. There has~     been no rigorous research examining the usefulness of CST for patients with migraine despite~     the impression of beneficial effects. Our limited preliminary data show significant,~     sustained benefit of CST in a small group of patients with migraine. The First Specific Aim~     is to determine the feasibility of developing a clinical trial comparing craniosacral therapy~     versus low-strength static magnets (attention-control complementary therapy) as a treatment~     for preventing migraine headaches. Patients with migraine, with or without aura, under care~     of a neurologist will be studied. After an 8-week baseline period, they will be randomized to~     one of two groups: 1) usual medical care plus 8 weeks of CST; or 2) usual medical care plus 8~     weeks of attention-control complementary treatment. Primary outcome measures will include: 1)~     headache-related quality of life, 2) headache frequency, and 3) perceived benefit in those~     receiving treatment. The Second Specific Aim is to identify relevant secondary outcomes~     associated with usual care plus adjunctive craniosacral therapy for migraine. Data collection~     will include demographics, headache intensity and duration, health status, headache-related~     disability, health care utilization, and medication use. The Third Specific Aim is to~     identify and find solutions for potential problems in conducting a larger clinical trial to~     assess the efficacy of CST for the prevention of migraine. Patients will be recruited from~     the University of North Carolina Headache Clinic and from local neurological practices.~     Duration of the study for each subject is 16 weeks. Length of the entire project is 2 years.~   "
221065|NCT00665223|"~     The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic~     treatment of Huntington's disease.~   "
221066|NCT00665210|"~     Hip implants come in different sizes. Currently, surgeons predict the implant size that will~     be needed using an analogue method whereby photos of the implant sizes are overlaid on the~     x-rays. In this study, we propose to use a digital, computerized method of templating which~     we expect will be more accurate than the overlay method.~   "
221067|NCT00665197|"~     Hypothesis: In the management of advanced oesophageal cancer, to determine if a shorter~     regime of external beam radiotherapy (using higher daily doses, and combined with~     intraluminal high dose rate brachytherapy) is not inferior in the palliation of dysphagia~     than a more protracted course of external beam radiotherapy (using lower daily doses and~     combined with equal intraluminal high dose rate brachytherapy).~   "
221068|NCT00665184|"~     Parkinson disease is a degenerative neurologic condition characterized by slowness of~     movement, tremor, and loss of balance control. It results in significant degrees of~     disability for affected individuals. Exercise and medication management are two treatments~     frequently used to treat Parkinson disease, and although some individuals benefit from these~     treatments, by what effect exercise works is presently not known. We will examine muscle~     structure and movement control responses to strengthening exercises and compare them to the~     therapeutic response observed as a result of medication intake. This process will allow us to~     better understand the mechanisms underlying the therapeutic effects of strengthening exercise~     for persons with Parkinson disease.~   "
221083|NCT00664976|"~     This project is a randomized controlled trial of electroconvulsive therapy (ECT) compared to~     treatment as usual (TAU) in the treatment of treatment resistant depression (TRD) in bipolar~     disorder. The purpose of the trial is to document the effect size, relative effect size and~     adverse effects of ECT in this condition. A specific purpose is to gain more knowledge about~     the effect on cognitive function.~   "
221084|NCT00664963|"~     The purpose of this study is to compare the effectiveness of the treatment with~     balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX~     uncoated stent in patients with ischemic infrapopliteal arterial disease.~   "
221566|NCT00658658|"~     The primary objective of this study was to evaluate the safety and pharmacokinetics of up to~     3 different dose schedules of panitumumab in pediatric patients with solid tumors.~   "
221069|NCT00665171|"~     Background: Infertility affects up to 15% of married couples. About half are attributable to~     female factors, among which anovulation is the leading cause. Some 5% of all women of~     reproductive age are anovulatory due to the polycystic ovarian syndrome (PCOS). PCOS causes~     also major health and cosmetic problems and significantly affects quality of life. PCOS is~     associated with cardiovascular morbidity and Type 2 diabetes mellitus, but it is unclear~     whether these are caused by the ovarian dysfunction or result from a common denominator.~      Working hypothesis and aims: Whole genome analysis of multigenerational families in which at~     least one woman is affected by PCOS may significantly reduce the numbers needed to verify the~     specific genes, involved in the causation of PCOS.~      Methods: Registration of multigenerational families and production of personal files with~     full workup for the presence of PCOS or its absence (in the women participants). Drawing of~     blood, extraction and preservation of DNA. Analysis of all informative SNPs in the genomes of~     the participants on a specific microarray chip. Statistical analysis of the results.~      Expected results: Verification of the loci and putative genes, associated with the appearance~     of PCOS.~      Importance: Elucidation of the specific genes underlying the pathology of PCOS. Probable~     implications to Medicine: Paving the way for targeted treatment of the problems, associated~     with PCOS, based on the clear knowledge of its underlying cause(s).~   "
221070|NCT00665158|"~     We will perform a randomized, controlled trial, the primary aim of which is to assess the~     effectiveness of a behavioral-based physical activity program in the prevention and treatment~     of obesity and related co-morbid conditions in a primary care setting. We hypothesize that~     the prevention and/or reduction of obesity and related co-morbidities in patients randomized~     to an individualized education and behavior counseling group will be greater by comparison to~     those randomized to a group that receives standard care alone.~   "
221071|NCT00665145|"~     The primary and secondary objectives of this study are:~      Primary: To evaluate stem-cell-mobilization in subjects with diabetic neuropathy receiving~     SB-509. Stem cell mobilization will be assessed by evaluating the presence of stem cells~     circulating in peripheral blood.~      Secondary: To evaluate the safety of SB-509 in subjects treated with SB-509 with diabetic~     neuropathy; and to compare the effect of SB-509 versus placebo on a pre-defined~     multi-endpoint analysis that includes visual analog scale for pain intensity (VASPI), total~     neuropathy score (TNS), evoked nerve conduction velocity (NCV) and quantitative sensory~     testing (QST)~   "
221072|NCT00665132|"~     This study is being done to see how well a new investigational medical device, the StimRouter~     (STR) System, will work to treat the chronic pain in people who have failed previous~     treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been~     treated for CTS pain before including surgical carpal tunnel release, but without good~     results, and they are still having pain. The study will look at both the good and bad effects~     of the StimRouter System for treating this kind of pain and as a general peripheral nerve~     stimulation device for treating chronic pain. The study will also help to understand other~     possible uses for the StimRouter System.~   "
221073|NCT00665119|"~     Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and~     opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an~     opioid drug) could improved respiratory pattern and effort in mechanically ventilated~     patients with rapid shallow breathing or high respiratory rate.~   "
221074|NCT00665106|"~     Evaluation of safety and tolerability of a single injection of NOVA63035 Corticosteroid~     administered at one of four doses in patients with diabetic macular edema (DME) secondary to~     diabetic retinopathy~   "
221075|NCT00665093|"~     This trial is conducted in Europe. The aim of this observational study is to evaluate the~     glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under~     normal clinical practice conditions.~   "
221076|NCT00665067|"~     Researchers will use abnormal blood and/or bone marrow cells, or materials derived from these~     abnormal cells, like DNA, RNA, protein or plasma, in laboratory studies. Toenail clippings~     will provide normal material like DNA for comparison with the abnormal material derived from~     the blood and/or bone marrow. The results of these studies will be correlated with subjects'~     disease symptoms and response to their experimental treatment. The MPD-RC researchers are~     interested in studying molecules from the blood and bone marrow, the exact molecules changing~     over time with the investigators choosing only the most promising for investigation.~      The investigators are attempting to better understand the causes of MPD and to develop~     improved methods for the diagnosis and treatment of these diseases. These syndromes carry a~     high risk of developing leukemia. It is important to continue to learn more about these blood~     cancers and to learn more about the effectiveness and potential side effects of various~     treatments. It is believed that further basic knowledge about these cancer cells as well as~     the effects of treatment will lead to the improvement of current therapies and the~     development of entirely new treatments for these diseases. The MPD-RC is hoping to determine~     if a number of laboratory tests (biomarkers) will allow for the prediction of response in~     future patients to the treatment they would receive.~   "
221077|NCT00665054|"~     Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male~     subjects suffering from erectile dysfunction as compared to placebo- To assess the influence~     of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile~     dysfunction following treatment with vardenafil as compared to placebo~   "
221078|NCT00665041|"~     Assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte~     donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS~     Secondary Objectives~      Estimate the effects of a quinagolide dose-titration regimen compared to placebo in~     peritoneal fluid accumulation, incidence of ascites, OHSS symptoms and clinical laboratory~     parameters of haemoconcentration~   "
221085|NCT00664950|"~     Elderly patients with an intertrochanteric hip fracture will be randomized to receive either~     a sliding hip screw (SHS) (control group) or InterTAN intermedullary nail (IMN) (experimental~     group) for surgical fixation of their hip fracture. This study will assess functional and~     mortality outcomes for elderly patients with hip fractures.~   "
221098|NCT00664781|"~     RATIONALE: rucaparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying the side effects and best dose of rucaparib and to~     see how well it works in treating patients with locally advanced or metastatic breast cancer~     or advanced ovarian cancer.~   "
221086|NCT00664937|"~     Exercise-induced bronchoconstriction (EIB) is a condition where airways tighten when you~     exercise and may cause coughing, wheezing, or shortness of breath. In many patients, this~     condition can cause lung function to drop making it harder to breath. An instrument called a~     spirometer is commonly used to measure lung function. This traditional means of assessing~     lung function in asthma is limited in its ability to provide information as to where in the~     lung the tightness is. Hyperpolarized helium magnetic resonance imaging (3He MRI) is a novel~     way to see the where air is going in the lungs using an MRI and special gas. The ability to~     see where the air can and cannot reach in the lungs may help show more accurately if a~     medication is working to make the asthma better. The purpose of this study is to examine~     patients with EIB in order to see if 3He MRI provides a better way to measure lung function.~     Patients will be given either montelukast sodium, a drug to improve the ability to breath~     with EIB, or placebo and then put on a treadmill to induce an occurrence of airway~     constriction. The patient's lung function will be measured more than once using both the~     spirometer and the 3He MRI.~   "
221087|NCT00664924|"~     The Remote Physiological Monitoring System (RPM™) is a wireless technology for physiological~     monitoring. The RPM™ is designed to capture, transmit and remotely monitor the vital signs of~     a patient or group of patients. The RPM™ allows the patient to carry an unobtrusive unit and~     sensor array, which is able to store and/or forward its data via existing communication~     networks. This data is archivable and can be made available to a monitoring station or~     stations. This approach obviates the need to provide new and expensive infrastructure to~     support the system since it is designed to 'piggy-back' on the existing network.~      A major clinical advantage of the RPM™ and the principal reason why it may offer a benefit to~     patients, is that it provides continuous remote monitoring of vital signs, in contrast to the~     current situation for ward patients, where there is intermittent vital signs monitoring. This~     is a major advantage for patients and hospital staff, since there is increasing evidence that~     demonstrate early recognition and treatment of clinical events, e.g., shock, can save lives;~     the concurrent cost and labour saving is a further obvious benefit.~      The RPM™ uses wireless technology to overcome the portability problems associated with~     conventional patient monitoring systems. The RPM™ consists of the following system~     components:~        1. Physiological Monitoring Unit (PMU)~        2. Data Aggregation Server (DAS)~        3. Clinical Monitoring Position (CMP) To validate the RPM™ device for regulatory approval,~          BRYTECH will evaluate the RPM™ in a clinical setting, thereby ensuring that the system~          is trustworthy and acceptable to health professionals as a monitoring system in~          patients. The study proposes to evaluate the accuracy and reliability of the RPM™~          compared to monitors commonly used in the medical practice under the standard conditions~          of medical practice The study also proposes to evaluate notification and alarm systems,~          the communications interface and non-interference with existing systems, devices,~          networks and procedures as well as the incremental nursing workload associated with the~          integration of the RPM™ in a clinical environment. The RPM™ and reference physiological~          monitoring devices will be compared for physiological monitoring capabilities in 40~          patients.~   "
221088|NCT00664911|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating~     older patients with solid tumour.~   "
221089|NCT00664898|"~     This is an open-label, multicenter, Phase Ib study to be conducted at approximately eight~     sites in Europe and the U.S. designed to evaluate the safety, pharmacokinetics, and activity~     of SGN-40 when combined with bortezomib in patients with multiple myeloma that is relapsed or~     refractory after at least one prior systemic treatment regimen.~   "
221090|NCT00664885|"~     This study is a randomized controlled trial to test whether Culturally Sensitive~     Collaborative Treatment (CSCT) would improve the outcome of depressed patients visiting~     non-psychiatric settings in Taiwan.~   "
221091|NCT00664872|"~     The purpose of this study is to determine the case manager are effective in the treatment of~     suicide attempters.~   "
221092|NCT00664859|"~     The current study is designed to test the long-term (12-month) safety and efficacy of~     LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia~   "
221093|NCT00664846|"~     The purposes of the study are to analyse the cross-section data of secondary stroke~     prevention in China and to carry out a standard medical management including medicine and~     interactive education program,and to evaluate the efficacy and safety of the standard medical~     management in secondary stroke prevention.~   "
221094|NCT00664833|"~     This is a multicentre, cluster-randomized, open-label flexible dose study with a 2x2~     factorial design with administration of vardenafil at a dose of 5, 10 and 20 mg doses in~     males with erectile dysfunction.The treatment period is for 12 weeks, after a 4 week~     unmedicated period for subjects taking ED medication. For ED treatment-naïve subjects (ie,~     previously not treated with ED medication), the unmedicated period can be only 2~     weeks.Approximately 150 investigational centres may be utilised with approximately 10~     subjects screened and entered into a 4 week treatment free period at Visit 1 to subsequently~     enroll approximately 1380 subjects to therapy. Each centre should enroll 10 subjects. Sites~     should try to recruit approximately 50% of subjects who have not previously tried oral PDE5~     inhibitor therapy for erectile dysfunction. An attempt should be made to enroll subjects~     whose partners are interested in being involved.Sites will be randomized in a 1:1:1:1 ratio~     to receive either the education intervention at the Primary care Physician (PCP) level, at~     the subject level, both levels or no intervention (usual care). The PCP education program is~     an accredited CME program and included a comprehensive overview on the screening and~     diagnosis of ED, the available treatment options and appropriate treatment selection, as well~     as subject and partner counseling. The subject education was a two-pronged approach which~     included physician-to-subject instruction and a direct-to-subject education method. After the~     unmedicated period, treatment was initiated with vardenafil 10 mg tablets for 4 weeks. This~     will be followed by a flexible dose titration period of 4 weeks during which subjects may~     maintain the previous dosage regimen or will step up to 20 mg of vardenafil or will step down~     to 5 mg vardenafil. There is a final 4 week treatment period where the previous dosage~     regimen is either maintained, increased or decreased by one step according to the three~     applicable dosage strengths of vardenafil (5, 10 or 20 mg). The highest applicable dosage~     regimen of 20 mg vardenafil will not be exceeded. A 24 hour follow-up phone call is required~     within 24 hours of the last dose of vardenafil to collect data concerning serious adverse~     events, if needed.~   "
221095|NCT00664820|"~     The purpose of the present study is to examine the utility of probiotics as an adjunctive~     therapy (in addition to patients' pharmacotherapy) for the treatment of Rheumatoid Arthritis.~      We hypothesize that specifically selected probiotics, Lactobacillus rhamnosus GR-1 and L.~     reuteri RC-14, can alleviate symptoms of RA and thereby increase the daily activity of these~     patients.~   "
221096|NCT00664807|"~     To generate a list of potential genetic markers that correlate with an increased risk of~     life-threatening arrhythmias.~      To evaluate ECG-based risk markers such as heart rate variability and T-wave Alternans for~     their association with arrhythmic events.~   "
221097|NCT00664794|"~     Surgical repair of full-thickness tears of the rotator cuff is a controversial issue, with~     several procedures currently being used to treat the tear. The two most common treatments at~     this point in time are arthroscopic cuff repair with and without acromioplasty. However, an~     arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as~     one that includes acromioplasty, but without threatening the shoulder stability that is~     provided by the acromion and coracoacromial ligament. This prospective study examines the~     hypothesis that appropriate shoulder function can be restored through execution of the~     traditional arthroscopic cuff repair without acromioplasty.~   "
221099|NCT00664768|"~     This study involves the use of 2 different Neocate formulas: a control formula called Neocate~     Infant and a test Neocate formula. These kinds of formulas are for use in children from birth~     to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other~     gastrointestinal disorders. The purpose of this study is to compare the control and test~     Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used~     in subjects with CMA.~      This study will also look at the test Neocate formula to see if it is hypoallergenic when~     used in subjects with CMA.~   "
221100|NCT00664755|"~     This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP)~     versus varenicline.~   "
221101|NCT00664742|"~     This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release~     (80 mg once daily) in patients with metabolic syndrome~   "
221102|NCT00664729|"~     Reductions in fat oxidation and resting metabolic rate (RMR) are associated with normal aging~     and are accelerated with menopause. As a result, postmenopausal women have an increased risk~     of abdominal obesity and ultimately the metabolic complications that lead to the insulin~     resistance syndrome and its associated risks (hyperlipidemia, type 2 diabetes, and coronary~     heart disease). Thus, there is a need to determine the most successful treatment to reduce~     visceral obesity in postmenopausal women. The purpose of this study is to determine if~     dietary-induced weight loss alone and/or weight loss combined with exercise at low and high-~     intensities differentially affect the reduction in visceral adipose tissue in postmenopausal~     women with abdominal obesity.~   "
221103|NCT00664716|"~     Safety and efficacy of BG9924 in RA participants that have had an inadequate response to~     disease-modifying anti-rheumatic drug (DMARD) therapy.~   "
221104|NCT00664703|"~     The study will evaluate the effectiveness of the nonstimulant medication lobeline in~     improving symptoms of attention deficit hyperactivity disorder in adults.~   "
221105|NCT00664690|"~     Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex~     started preoperatively and continued for 3 days. Rescue medications required as well as pain~     scores will be assessed using a patient diary to evaluate the effect of celebrex in~     controlling transitional pain~   "
221106|NCT00664677|"~     This study is designed to determine the safety, maximum tolerated dose,dose limiting toxicity~     of Terameprocol(EM-1421)and determine the pharmacokinetics (clearance from the blood)of~     Terameprocol(EM-1421)given as intravenous infusion three times a week in patients with~     leukemia.~   "
221107|NCT00664664|"~     This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in~     otherwise healthy adults with primary insomnia primarily with complaints of maintaining~     sleep.~      Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on~     study.~   "
221108|NCT00664651|"~     Our primary research question is to find out whether there is a genetic component to the~     development of joint contractures following knee surgery, through the application of lab~     techniques.~   "
221109|NCT00664638|"~     To investigate the clinical utility of renal denervation in the treatment of refractory~     hypertension.~   "
221110|NCT00664625|"~     The primary purpose of this study is to evaluate the safety profile and tolerability of~     single oral doses of BMS-791325 in subjects with chronic hepatitis C infection~   "
221111|NCT00664612|"~     Intubation is frequently required for trauma patients as part of the resuscitative effort.~     When the stability of the cervical spine is unknown, the potential for spinal cord damage~     during intubation is significant; the question of the safest intubating technique has not~     been resolved. Previous Studies have evaluated Macintosh Laryngoscopy, Bullard Laryngoscope,~     face mask ventilation, fibre-optic guided oral and nasal intubation, esophageal Combitube®,~     Laryngeal Mask Airway® (LMA), and Intubating Laryngeal Mask Airway® (ILMA) use with respect~     to cervical spine movement. Our previous study evaluated the Intubating Lighted Stylet~     (Lightwand®) and GlideScope® versus the Macintosh Laryngoscope.~      Another method of securing endotracheal intubation, approved and in routine use, is the~     AirTraq® videolaryngoscope (ProMedic, Inc, Bonita Springs, FL, USA). The AirTraq~     videolaryngoscope is a videolaryngoscope with an external video display of the glottic~     opening and an endotracheal tube track to guide the ETT through the vocal cords~     (www.airtraq.com). When a clear view of the vocal cords is obtained, the endotracheal tube~     may be advanced into the trachea. This technique can be performed rapidly and safely and~     there is the perception that it involves less cervical spine movement than direct~     laryngoscopy.~      We propose to study the AirTraq videolaryngoscope to determine if its use would result in~     reduced cervical spine movement during intubation.~   "
221112|NCT00664599|"~     The purpose of this study is to find if Rituximab can improve severe ocular lesions of~     Behcet's Disease.~   "
221113|NCT00664586|"~     This is a Phase I continuous infusion study designed to explore if constant concentration~     over time adds to the effectiveness of terameprocol without increasing toxicity. It will also~     explore weekly dosing as an option.~      Tumor response assessments will be performed following every two (2) cycles of therapy. All~     subjects will undergo a follow-up visit 30 days following their last dose of terameprocol.~     Circulating tumor cells (CTC) will be quantified pre dosing and on day 15 after first dose of~     each cycle. Needle biopsy specimens will be taken prior to therapy and one week after first~     dose, if possible, to assess for tumor markers (cdc-2 and survivin). Tumor markers, for~     example prostate specific antigen (PSA) will also be measured on day 15 of each cycle (if~     elevated on study entry). Pharmacokinetic parameters will be derived from analysis of blood~     samples collected during the first 24 hour infusion.~   "
221114|NCT00664573|"~     To observe the long-term treatment with BG9924 when administered to participants with RA who~     previously participated in a Biogen Idec Study.~   "
221115|NCT00664560|"~     We will evaluate the efficacy of PN400 and an active comparator in patients that have~     Osteoarthritis of the knee.~   "
221116|NCT00664547|"~     The purpose of the trial was to examine the independent effects of equivalent diet- or~     exercise-induced weight loss on obesity and related cardiovascular health risk factors. We~     hypothesized that exercise would result in greater reductions in obesity and health risk~     factors that equivalent diet (caloric restriction).~   "
221117|NCT00664534|"~     This study is designed to look at how best to start and then gradually intensify (as needed)~     the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.~   "
221119|NCT00664508|"~     The purpose of this study is to describe the 3D joint biomechanics of the lower extremities~     of patients having had a total hip replacement or hip resurfacing surgery as compared to a~     healthy age and weight matched control group during level walking, stair ascent and descent,~     and entering and exiting the front seat of a car.~   "
221120|NCT00664495|"~     The purpose of the study was to assess the effects of equivalent diet- or exercise-induced~     weight loss and related insulin resistance in abdominally obese women.~   "
221121|NCT00664482|"~     Argos Therapeutics, Inc., (Argos) proposes to study AGS-006 in a subject with newly diagnosed~     resectable pancreatic cancer. The AGS 006 immunotherapeutic may potentially offer a desired~     additional option to conventional treatments for pancreatic carcinoma.~   "
221122|NCT00664469|"~     In South Asian Canadians with documented coronary artery disease or diabetes and~     hypercholesterolemia with LDL-C levels > 2.0 mmol/L after 4 weeks of monotherapy with any~     statin: To compare the percent (%) of patients who achieve an LDL-C concentration of~     2.0mmol/L after a 6-week course of treatment with ezetimibe 10 mg/day co-administered with~     any statin at any dose versus doubling of the current statin dose.~   "
221123|NCT00664456|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing~     hormone-releasing hormone agonists may lessen the amount of androgens made by the body.~     Internal radiation uses radioactive material placed directly into or near a tumor to kill~     tumor cells. Giving luteinizing hormone-releasing hormone agonist together with an iodine I~     125 implant may be an effective treatment for patients with prostate cancer.~      PURPOSE: This randomized phase III trial is studying how well giving luteinizing~     hormone-releasing hormone agonist therapy together with an iodine I 125 implant works with or~     without additional luteinizing hormone-releasing hormone agonist therapy in treating patients~     with previously untreated prostate cancer.~   "
221124|NCT00664443|"~     The overall goal of this study is to better understand the factors leading to successful~     dispatch-assisted CPR instructions and to ultimately save the lives of more cardiac arrest~     patients. Specific objectives are to: 1) Determine the ability of 9-1-1 dispatchers to make~     the diagnosis of cardiac arrest over the phone; 2) Quantify the frequency and impact of~     perceived agonal breathing on cardiac arrest diagnosis; 3) Measure the frequency with which~     dispatch-assisted CPR instructions can be successfully completed in out-of-hospital cardiac~     arrest cases; and 4) Measure the impact of dispatch-assisted CPR instructions on bystander~     CPR and survival rates for out-of-hospital cardiac arrest.~   "
221125|NCT00664430|"~     The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in~     participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing~     hemodialysis who are resistant to treatment with calcitriol.~   "
221126|NCT00664417|"~     Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza~     vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity~     using adjuvants were initiated. The present study is part of this endeavor. It is primarily a~     formulation/dose-finding study with a secondary aim at generating safety and immunogenicity~     data for the final formulation for the development of a pre-pandemic vaccine.~   "
221127|NCT00664404|"~     Objectives:~        -  To evaluate neural correlates associated with emotional processing during nicotine~          withdrawal preferentially involving the amygdala and associated areas within the~          corticolimbic and mesolimbic circuitry. We hypothesize that relative to a pre-quit~          baseline, post-quit nicotine withdrawal will result in increased activity to negative~          emotional cues, in contrast to other cues, in one or more areas of interest, and~          particularly in the right cerebral hemisphere.~        -  To determine if bupropion and varenicline moderate patterns of brain activation during~          post-quit nicotine withdrawal. We hypothesize that relative to placebo, bupropion and~          varenicline will attenuate the effects of post-quit nicotine withdrawal on emotional~          processing, reducing activation to negative emotional cues, relative to other cues, in~          one or more areas of interest, and particularly in the right cerebral hemisphere.~        -  To determine if genotype (DRD2 TaqA2 allele and the ins variant of the -141C ins/del~          DRD2) moderates patterns of brain activation during post-quit nicotine withdrawal.~   "
221128|NCT00664391|"~     The purpose of this study is to demonstrate the safety of the gynecological formulation in~     normal and usual usage condition of Dermacyd Breeze.~   "
221129|NCT00664378|"~     This is a clinical research study that is designed to test the safety of CYT997 when given to~     patients with multiple myeloma and to test if CYT997 has any activity against that cancer.~   "
221130|NCT00664365|"~     This study is the first administration of GSK958108 to man. The study will evaluate the~     safety, tolerability and pharmacokinetics of single ascending doses of GSK958108 and evaluate~     the effect of food on GSK958108 pharmacokinetics~   "
221131|NCT00664352|"~     The objective of this study is to compare the efficacy of two concentrations of Juvidex with~     placebo on the healing of split thickness skin graft donor sites~   "
221132|NCT00664339|"~     We evaluated the preventive impact of vaccination on subsequent death events in 117 severe~     congestive heart patients requiring ventilator support without endotracheal intubations and~     aggressive medical therapy.~      They were randomly allocated in a single-blind manner as a unique intramuscular influenza~     vaccination or as controls.~      The first primary outcome evaluated at 6 months follow-up - cardiovascular death - occurred~     in 3% of the patients in the vaccine group Vs 17% in controls (p=0.022). The composite end~     point occurred in 33% of the patients in the vaccine group Vs 74% in control group, p =~     <0.001.~   "
221133|NCT00664326|"~     This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to~     evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or~     unresectable renal cell cancer (RCC).~   "
221134|NCT00664313|"~     The antibiotic linezolid when given for the treatment of multi-drug resistant tuberculosis is~     safe and tolerated at a low dose (600 mg daily) for a limited duration (16 weeks)~   "
221323|NCT00661843|"~     Insomnia is common in the elderly population and is associated with increased health~     problems, reduced quality of life and greater use of sleep inducing drugs. This research aims~     to examine the effectiveness of Yoga practice to treat insomnia in elderly people, determine~     the ability to enhance their quality of life and determine if it is suitable to western~     culture and conditions.~   "
221135|NCT00664300|"~     Gilles de la Tourette's syndrome is a childhood onset inherited neuropsychiatric disorder~     characterised by the presence of both multiple motor tics and one or more vocal tics~     (noises), with psychiatric and/or behaviour disorders (such as obsessive compulsive~     behaviour…).~      This disease is associated with an dopamine system imbalance which could be responsible of a~     specific trouble in the recognition in some facial expression. This has been already shown in~     Gilles de la Tourette patients with obsessive compulsive behaviour.~      We hypothesise that patients with Gilles de la Tourette's syndrome present a dysfunction of~     voluntary and automatic treatment of emotional information.~      The main purpose of this study is to show if patients with Gilles de la Tourette's syndrome~     present a lack of specific facial expression recognition of emotion and determinate more~     precisely if this alteration involves the cortical way (high frequency way) or the under~     cortical way (low frequency way).~   "
221136|NCT00664287|"~     The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on~     lowering bad cholesterol and raising good cholesterol.~   "
221137|NCT00664274|"~     This project will explore the relationship between catechol-O-methyltransferase (COMT)~     Val158/108Met genotype and response to a 12-week computerized neurocognitive rehabilitation~     (CRT) given to chronic schizophrenic patients.~   "
221138|NCT00664261|"~     RATIONALE: The Clinical Effort Against Secondhand Smoke (CEASE) program may be more effective~     than standard care in increasing the number of parents who stop smoking.~      PURPOSE: This randomized clinical trial is studying how well the CEASE program works compared~     with standard care in helping parents stop smoking.~   "
221139|NCT00664248|"~     The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with~     acne vulgaris.~   "
221140|NCT00664235|"~     Long-wave infrared imaging can be used to identify skin temperature changes associated with~     underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is~     as effective as the Braden Score in predicting nosocomial pressure ulcers.~   "
221141|NCT00664222|"~     The purpose of this study is to evaluate the effects of spironolactone and furosemide on~     insulin resistance in patients with chronic heart failure.~   "
221142|NCT00664209|"~     The purpose of this study is to determine whether treatment of H. pylori (an infection of the~     stomach) improves treatment effectiveness in patients with Parkinson's disease and motor~     fluctuations.~   "
221143|NCT00664196|"~     This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells~     (designer T cells) in hormone refractory prostate cancer.~   "
221144|NCT00664183|"~     The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic~     retinopathy patients.~   "
221145|NCT00664170|"~     The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere~     in patients with advanced cancer.~   "
221146|NCT00664157|"~     Parkinson'disease is a neurodegenerative disorder characterised by bradykinesia, rigidity,~     rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine~     agonists usually leads to a dramatic improvement of symptoms, but disease progression~     nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus is~     now considered the gold standard surgical treatment.~      Parkinson'disease mainly affects the nigrostriatal dopaminergic system which is linked to the~     limbic system and could be responsible of a specific trouble in the recognition in some~     facial expression.~      We hypothesise that patients with Parkinson'disease present a dysfunction of voluntary and~     automatic treatment of emotional information.~      The main purpose of this study is to show if patients with Parkinson'disease present a lack~     of specific facial expression recognition of emotion and determinate more precisely if this~     alteration involves the cortical way (high frequency way) or the under cortical way (low~     frequency way).~      We also examine the role of L-Dopa and the deep brain stimulation on emotion perception~   "
221147|NCT00664144|"~     The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and~     treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult~     patients, previously treated or not with urate oxidase, with relapsing aggressive~     non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky~     disease at diagnostic of relapse.~      The secondary objectives were to :~        -  evaluate the efficacy of rasburicase in terms of renal protection,~        -  evaluate the safety of rasburicase in the two cohorts of patients,~        -  correlate efficacy and safety results with antibodies generation/level.~   "
221148|NCT00664131|"~     Treatment of acute lymphoblastic leukemia achieves high cure rate, but is potentially~     neurotoxic.~      Long-term neurologic morbidity in survivors and its effect on function are inadequately~     studied.~      Neurologic outcomes will be assessed through an investigator administered questionnaire~     followed by comprehensive neurologic examination by the study neurologist.~   "
221149|NCT00664118|"~     Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first~     stage of labor would be an effective and safe health care procedure for nulliparas. Doulas,~     women with labor experience trained for parturients, is a new way to alleviate the~     psychological stress from the laboring pain. Previous data in our study showed that doula~     accompany is a good method in shortening the progress of labor used in the active phrase of~     the first stage of labor, and decreasing the rate of cesarean delivery. Investigators~     hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be~     a superior means for effective pain relief, decreased rate of cesarean section, and shortened~     duration of labor.~   "
221150|NCT00664105|"~     RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination~     with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of~     docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20~     mg/m2 appears to be a well-tolerated weekly dose when combined with either cisplatin 25~     mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation~     therapy.~      PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly~     docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic~     docetaxel/carboplatin consolidation therapy on overall response rate, survival,~     progression-free survival, safety and toxicity in patients with locally advanced NSCLC.~   "
221567|NCT00658645|"~     The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance~     phase of schizophrenia compared to placebo.~   "
221151|NCT00664092|"~     The primary aim of this project is to study more closely the role played by post-release~     aftercare in the outcomes of criminal offenders who received in-prison substance abuse~     treatment. Prison-based therapeutic communities (TC) (Pelissier et al., 2001; Wexler, 1995)~     have demonstrated efficacy, especially when combined with post-release TC aftercare (Melnick~     et al., 2001). The aims of this project are important from a public health perspective as~     there may be treatment matching, case management, and financing factors that could be~     manipulated to enhance the cost-effectiveness of community-based substance abuse treatment~     for offenders leaving prison. It is possible that both TC and Oxford House(OH) aftercare~     modalities increase abstinence social support, self-efficacy, and employment, which mediate~     reductions in drug use, reincarceration, and health problems, but overall benefits are likely~     to be greater for TCs because they employ professional services and empirically based~     behavioral strategies. However, OHs might have advantages compared to more traditional~     post-incarceration modalities (e.g., low costs). Bringing scientific methods to the~     examination of TCs and the OH community-based recovery models for addiction might help to~     identify the active ingredients of these recovery settings.~   "
221152|NCT00664079|"~     Thyroid hormones are substances naturally made by the body and are important to many of your~     body's basic functions such as breathing and brain function. We are investigating whether or~     not these hormones are at lower levels in critically ill children which could lead to further~     health problems. We hope to get a better understanding of hormone levels and their effects on~     critically ill children to better help other children in the future.~   "
221153|NCT00664066|"~     This is a post-authorisation safety study to assess the incidence and severity of all~     pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect &~     describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.~   "
221154|NCT00664053|"~     The purpose of this study is to examine whether muscle strength and balance will improve in~     women with frailty selected for dehydroepiandrosterone sulfate (DHEAS) levels below 550 ng/dl~     treated with DHEAS supplementation and Hatha yoga. Investigators believe the effects of both~     treatments will improve outcomes more than either treatment alone and may be additive; in~     addition, lean body mass, skeletal muscle mass, markers of bone turnover and physical~     performance will improve following treatment with DHEA and/or yoga.~   "
221155|NCT00664040|"~     Cardiovascular disease (CVD) is the leading cause of death in the United States and many~     people that die of heart disease have no previous symptoms. This study will look specifically~     at the response to four short-term environmental exposures including: the body's response to~     a cold stimulus, to a high fat milk shake, to aspirin, and to a high and low salt diet. These~     interventions are all known to influence CVD and people can have different responses to these~     interventions, which may be due, at least in part, to differences in genetic make up.~   "
221156|NCT00664027|"~     To determine the effects of three different doses of bardoxolone methyl administered orally~     on the kidney function (glomular filtration rate) in patients with diabetic nephropathy.~   "
221157|NCT00664014|"~     This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy +~     placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients~     with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies. 240 (120 in~     each group) patients are to be enrolled randomly into Tolvaptan group or placebo group.~     Subjects in Tolvaptan group will receive standard therapy + Tolvaptan (15-60mg/day), while~     those in control group receiving standard therapy + placebo. The starting dose of tolvaptan~     is 15mg and it could be titrated up to 30mg and then,if necessary, to the maximum of 60mg~     according to a certain titration scheme based on patients' response of serum sodium level.~     The study includes a 2-day screening period from day -2 to day -1, 7-day inpatient study~     treatment (day 1 to day 7 ). After study treatment, subjects will be Followed-up on safety~     events on day 14 - 16. The Primary Efficacy Variable is the change of serum sodium from~     baseline. For patients with Congestive Heart Failure (CHF) or hepatic cirrhosis, change of~     body weight, fluid balance and symptoms improvement of CHF and hepatic edema will be assessed~     as secondary efficacy variables.~   "
221158|NCT00664001|"~     Acute mountain sickness (AMS), high altitude pulmonary edema (HAPE), and high altitude~     cerebral edema (HACE) are complications of rapid ascent to high altitude. Several features~     suggest that raised intracranial pressure (ICP) may be an important factor in the~     pathogenesis of AMS. Magnetic resonance imaging of HACE patients has demonstrated that the~     oedema in HACE is of the vasogenic, rather that cytotoxic, type. Thus it is likely that~     cerebrovascular permeability has an important role in the development of AMS and HACE.~      Reactive oxygen species (ROS) have been shown to alter the permeability of the blood-brain~     barrier in severe ischaemia, causing vasogenic cerebral oedema. Endogenous antioxidant~     systems may have some capacity to respond to oxidative stress in hypoxia. The plasma~     concentration of urate, a powerful endogenous antioxidant, rises on acute exposure to high~     altitude and may play a crucial antioxidant role in systemic hypoxia. This antioxidant~     prevents free-radical induced cerebral oedema in animal models.~      There are numerous sources of ROS in hypoxia, including the mitochondrial electron transfer~     chain, haemoglobin (Hb) autoxidation and xanthine oxidase activity. There have been several~     reports of raised markers of oxidative stress in humans at moderate altitude (<3000m).~      Oral antioxidant supplementation with preparations containing vitamins C and E in humans at~     altitude has been shown to decrease breath pentanes (a marker of oxidative stress), and~     improve erythrocyte filterability. In a small randomised controlled trial, Bailey and Davies~     demonstrated a significant reduction in symptoms of AMS in subjects taking an oral~     antioxidant cocktail.~      The antioxidants alpha-lipoic acid, vitamin C and vitamin E act synergistically to provide~     membrane protection from free radical damage, and may protect against hypoxia-induced~     vascular leakage. We hypothesised that this combination of antioxidants would reduce the~     severity of acute mountain sickness, and reduce pulmonary artery pressures, in healthy~     lowlanders acutely exposed to high altitude.~   "
221159|NCT00663988|"~     Progress in composite tissue allotransplantation provides a new remedy for severely~     disfigured patients. We plan to carry out allograft composite tissue transplantation after a~     careful systemic preparation.~   "
221160|NCT00663975|"~     Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic~     insufficiency in CF patients <= 2 years of age.~      The results of this study are intended to be submitted to the FDA as part of the NDA package~     for marketing approval of PANCRECARB (DCI 1020).~   "
221179|NCT00663728|"~     This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting,~     as compared to placebo (dummy medication with no pharmacological activity), on the duration~     of erection from the moment when the patient perceived his erection to be hard enough for~     penetration until withdrawal from the partner's vagina leading to successful completion which~     may or may not have included ejaculation. The patient used the stopwatch for the above~     assessments. The efficacy of oral ED treatments is measured by questionnaires and patient~     diaries.~   "
221161|NCT00663962|"~     With Institutional Ethics Board approval and signed informed consent, a pilot investigation~     was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly~     assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days~     postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days~     postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and~     compliance of this drug regimen on this patient population. This assessment was necessary in~     order to plan a future fully powered randomized controlled trial looking at the efficacy of~     perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy~     pain.~   "
221162|NCT00663949|"~     Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and~     morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic~     patients they can not hinder the progression of renal disease completely. Pentoxifylline as a~     TNFa blocker may hinder progression of diabetic nephropathy in combination of captopril.~   "
221163|NCT00663936|"~     The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to~     treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive~     assessment.~      The secondary objectives of the study are to evaluate the safety of T-817MA and the~     activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to~     evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the~     ADCS-CGIC.~   "
221164|NCT00663923|"~     The purpose of this study is to determine whether cross-cylinder approach is more effective~     than routine method in laser correction of astigmatism.~   "
221165|NCT00663910|"~     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma~     skin cancer that has been treated with topical aminolevulinic acid may help doctors predict~     how patients will respond to photodynamic therapy.~      PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with~     nonmelanoma skin cancer.~   "
221166|NCT00663897|"~     Functional dyspepsia is a common symptom complex with significant impact on quality of life.~     There is no standard treatment for functional dyspepsia but therapeutic efficacy of proton~     pump inhibitor (PPI) and prokinetic agent have been proved in subsets of patients. This study~     has two aims:~        -  first is to compare the therapeutic efficacy of lansoprazole (a PPI) and mosapride (a~          prokinetic agent) for functional dyspepsia~        -  second is to investigate whether different subgroups of functional dyspepsia (e.g.,~          epigastric pain syndrome and postprandial distress syndrome) respond differently to PPI~          and prokinetic agent.~   "
221167|NCT00663884|"~     We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg~     voglibose with insulin glargine for 16 weeks after single administration of insulin glargine~     for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite~     administration of oral antidiabetic drug or insulin glargine.~   "
221168|NCT00663871|"~     Omega-3 fatty acids are a certain kind of fish fat that has recently been shown to have~     health benefits. This study will examine the effectiveness of fish oil supplementation for~     reducing the early signs of heart disease risk and for improving mood, impulsivity, and anger~     levels.~   "
221169|NCT00663858|"~     Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is~     characterized by an enlargement of the prostate occurring in human male over the age of 50~     which increases in prevalence with age, and among those aged 50 to 80, about 40% report~     moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve~     patients' quality of life which primarily depends on the severity of the symptoms of BPH.~     Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.~      For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection~     in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to~     52) are eligible to receive the active drug during the open-label part of the study (Week 52~     to 90).~   "
221170|NCT00663845|"~     This study is being conducted in US to obtain information on the efficacy, safety, and~     duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy~     medication with no pharmacological activity), in patients with co-morbid factors associated~     with erectile dysfunction (also called impotence). The duration of erection endpoint will be~     assessed by patient utilized stopwatch timings during each attempt at sexual intercourse.~     Elevated levels of total cholesterol or low levels of HDL may result in atherosclerosis and~     induce erectile dysfunction. Vardenafil (Levitra) is approved by the Food and Drug~     Administration for the treatment of erectile dysfunction. While there is no intent to assess~     the effect vardenafil has on blood lipids, the study will provide prospective data on men~     diagnosed with both ED and dyslipidemia.~   "
221171|NCT00663832|"~     This Phase Ib dose escalation study is designed to characterize the safety, tolerability and~     preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and~     prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.~   "
221172|NCT00663819|"~     The primary purpose of this prospective, randomized multicenter center study is to evaluate~     and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a~     bioabsorbable staple line reinforcement material compared with standard non-reinforced~     colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative~     anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.~   "
221173|NCT00663806|"~     Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an~     educational brochure. - Women with urinary tract infections were treated with Cipro XR. They~     were also given a brochure with information about urinary tract infections and later tested~     on the information.~   "
221174|NCT00663793|"~     We propose a study to determine the single-dose pharmacokinetics of these two novel~     formulations of testosterone in normal men with experimentally induced hypogonadism.~   "
221175|NCT00663780|"~     The objective of the study is to identify variations in subjects genetic makeup that~     segregate responders from non-responders in respect of response to Juvidex in the clinical~     trial RN1004-0082~   "
221176|NCT00663767|"~     This is a Phase 2 study designed to test the ability of investigational study drug~     ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to~     further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled~     in this study.~   "
221180|NCT00663715|"~     Sciatic nerve blocks are frequently used for anesthesia or analgesia for surgery of the lower~     legs. Currently, if ultrasound is used to find the sciatic nerve, the leg must be raised to~     locate the nerve with the ultrasound probe on the back of the thigh. In pediatric surgery,~     the patients are anesthetized (asleep) before the block is given. It is difficult for one~     person to administer the sciatic nerve block using this method. We would like to identify the~     sciatic nerve using ultrasound on the side of the thigh and its location to the adjacent~     structures.~   "
221181|NCT00663702|"~     The purpose of this study is to determine whether switching to subcutaneous administration of~     abatacept will be safe in participants with rheumatoid arthritis who previously received~     long-term therapy with intravenous abatacept~   "
221182|NCT00663689|"~     This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and~     toxicity of erlotinib in patients with asymptomatic brain metastasis advanced NSCLC who was~     benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more~     asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral~     erlotinib 150mg once daily until disease progression or unacceptable toxicity. These~     patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The~     response was evaluated by RECIST criteria after the patient received erlotinib 6 weeks.If the~     patients present with progress disease of brain metastasis after the therapy of erlotinib,~     the patients will receive irradiation of brain metastasis.If the response is stable~     disease,partial response or complete response,he will be examined by brain MRI every 12~     weeks.~   "
221183|NCT00663663|"~     Treatments teaching people how to manage pain have been used to treat chronic pain in the~     general population. The purpose of this study is to see if these treatments delivered over~     the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired~     amputation. Specifically, we want to determine if these treatments can help reduce the~     negative consequences that pain often causes in terms of a person's mood, daily activities,~     and enjoyment of life. We are also interested in finding out if these treatments decrease a~     person's pain.~   "
221184|NCT00663650|"~     This study is an equivalency study designed as a randomized clinical trial. Patients with a~     biopsy proven nodular periocular basal cell carcinoma (BCC) who have agreed to have surgical~     excision will be eligible. Study patients will undergo surgical excision of the lesion and~     then be randomized to having frozen section or permanent section pathological control. For~     those patients randomized to permanent section control the sample will be sent to pathology~     and surgical reconstruction will be performed. Patients randomized to frozen section will~     have additional margins re-excised before reconstruction depending on the pathologic results.~     Tumor clearance rates after surgical excision will be compared between the two techniques as~     a primary study question. Patients will be followed long-term to determine recurrence rates~     in the two groups. The study is designed to determine if the two techniques are equivalent~     within a given margin of error with respect to outcome measures.~   "
221185|NCT00663637|"~     The purpose of this study is to measure secretion accumulation within endotracheal tubes of~     mechanically ventilated patients and test the efficacy, safety and clinical impact of~     removing the secretions using novel airway management catheters (Complete Airway Management~     Catheters: CAM Rescue Cath and CAM Endotrach Cath).~   "
221186|NCT00663624|"~     In the Emergency Department (ED), diabetes is commonly encountered as a secondary diagnosis~     and many patients with uncontrolled diabetes are admitted to the hospital after initial~     evaluation in the ED. Currently there are no guidelines in the US for the management of~     hyperglycemia in patients with diabetes during the duration of evaluation and treatment in~     the ED. It is known that high blood glucose levels in hospitalized patients with diabetes are~     associated with increased risk of medical complications. In this study, we hypothesize that a~     defined two-step approach to the management of high blood sugars with insulin injections~     initiated in the ED may decrease length of stay in the ED or hospital, improve clinical~     outcome and prevent some hospital complications. In the first phase, patients with diabetes~     admitted to the ED that have a high blood sugar (BG 200mg/dL) will be randomized to receive~     scheduled aspart or the usual care as dictated by the ED physicians. In the second phase,~     patients enrolled in the first phase that are subsequently admitted to the hospital will~     receive a combination of detemir and aspart insulin or usual care as dictated by the~     Admitting Medicine Team. Detemir is a long-acting insulin which is given subcutaneously~     (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously~     several times a day and frequently before meals. Detemir and aspart insulins are approved for~     use in the treatment of patients with diabetes by the FDA. Usual care can be oral~     anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous~     insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin~     or insulin glargine.~      This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta~     and at Rush University Medical Center, Chicago, IL. Dr. Smiley will serve as principal~     investigator at the Atlanta site. A total of 120 patients will be recruited at Grady and 120~     patients at the Rush University Medical Center, Chicago, IL. This study is supported by Novo~     Nordisk.~   "
221187|NCT00663611|"~     Background:~      - In elderly individuals, an age-associated decline in the immune system s ability to~     function is believed to contribute to increased incidence of infection, autoimmune disorders,~     and cancer. This decline in immune system function may be related to the decline in the body~     s production of growth hormone, which helps regulate human development and may contribute to~     the health of the immune system. Researchers are interested in studying whether growth~     hormone, given as an infusion over time, can improve the function of the immune system and~     other body systems associated with good health.~      Objectives:~      - To study the effects of growth hormone administration on the immune systems of healthy men.~      Eligibility:~      - Healthy men between 25 and 50 years of age.~      Design:~        -  This protocol will involve three separate studies: Study I, Study IB, and Study II.~          Participants in Study I and Study IB may participate in Study II as directed by the~          researchers.~        -  Participants will be screened with a full medical history and physical examination, and~          will provide blood, urine, and stool samples; have a glucose tolerance test; and have~          other tests as required by the researchers.~        -  Participants will have an infusion pump with a small catheter inserted beneath the skin~          to administer the study chemicals (either growth hormone or placebo).~        -  Study I and Study IB participants will receive pulses of growth hormone through the~          infusion pump at regular intervals to monitor the body s response to the hormone. Study~          IB participants will receive a higher dose of growth hormone than Study I participants.~        -  Throughout the study period, all participants will have frequent blood and urine tests,~          as well as tests of glucose tolerance and metabolism, imaging studies, and other tests~          as required by the researchers.~        -  Study II participants will be divided into two groups. The first group will receive~          pulses of either growth hormone or placebo infusion at intervals throughout the day for~          4 weeks, followed by an 8-week period without infusions. The second group will receive~          conventional once-a-day infusion of growth hormone or placebo for 4 weeks, followed by~          an 8-week period without infusions.~        -  Throughout the study period, all participants will have frequent blood and urine tests,~          as well as tests of glucose tolerance and metabolism, imaging studies, and other tests~          as required by the researchers.~   "
221188|NCT00663598|"~     Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily~     life conditions in a large number of subjects with erectile dysfunction (ED)~   "
221189|NCT00663585|"~     Participants completing training in intensive meditation and continuing frequent practice for~     one year would experience reduced frequency, duration and severity of headaches along with~     improved awareness of the triggers of their symptoms, improved quality of life and mental~     health, improved heart rate variability, and reduced inflammation.~   "
221190|NCT00663572|"~     Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm~     infants.-Joint influence of environmental factor (early nutrition) and genetics factors on~     feeding behaviour setting- up in a particular population of infants of whom nutrition and~     life conditions during first weeks of life were purely controlled.~   "
221192|NCT00663546|"~     This study, conducted by the National Center for Parasitology, Entomology and Malaria Control~     of Cambodia s Ministry of Health and the National Institute of Allergy and Infectious~     Diseases, will explore whether the following factors confer protection against malaria and~     associated anemia: certain blood groups, the hemoglobin E variant, G6PD-deficiency and~     alpha-thalassemia. Malaria is caused by parasites (P. falciparum and P. vivax) that are~     transmitted to humans through mosquito bites. This protocol includes two studies, a cohort~     study and a P. vivax collection study.~      Individuals are eligible for enrollment in the studies as follows:~      Cohort study:~      Residents of all ages of Kandal, Ekapheap and Sangkumthmey villages (Thmar Da commune) who~     plan to remain in Thmar Da commune for the next 5 years.~      P. vivax collection study:~      2 years of age and older~      Participating in NIAID protocol 05-I- N210 ( Severe Malaria and Anti-malarial Drug Resistance~     in Cambodia ) and diagnosed with P. vivax malaria~      Participants undergo the following procedures:~      Cohort study:~      Baseline evaluation, including the following:~        -  Collection of demographic information~        -  Malaria history, temperature measurement and review of current symptoms, if any~        -  Blood draw of 300 microliters~        -  Additional blood draw of 10 milliliters in selected adults 18 years of age and older~      Treatment with artesunate-piperaquine at a commune health post for subjects who develop~     malaria~      Contact once a year for 5 years to determine continued residency in Thmar Da commune~      P. vivax collection study:~        -  Medical history and physical examination~        -  Hemoglobin level measurement~        -  Blood draw~        -  Treatment with chloroquine~        -  Blood draw 3 to 5 weeks after treatment in some patients 18 years of age or older~   "
221193|NCT00663533|"~     The purpose of this research study is to study an experimental vasectomy device called the~     Vas-X. This is an experimental study of this new approach to vasectomy.~   "
221194|NCT00663520|"~     The purpose of this study is to determine if women with chest pain and clean heart blood~     vessels have impaired blood flow to the heart due to problems with the small blood vessels~     that provide blood and oxygen to the heart. Impairment in the small blood vessels will be~     tested using ultrasound pictures of the heart, called myocardial contrast echocardiography.~     Since these small blood vessels are not seen in a coronary angiogram, which is an x-ray of~     the heart vessels using a dye containing iodine injected in the heart vessels, the problem~     may remain undiagnosed in women until the heart muscle becomes severely damaged.~      A second purpose is to identify if there is a common trait in the population of women with~     this tiny blood vessel dysfunction, which will be investigated by checking blood levels of~     certain chemical and hormones related to heart disease. Finally, we would like to investigate~     the relationship between depression and stress, and heart disease. We will do this by~     measuring cortisol (a hormone that serves as a measure of stress) and administering~     questionnaires that help to identify depression and stress.~   "
221195|NCT00663507|"~     The purpose of this research is to better characterize the components and mechanisms of the~     immune systems of persons with sickle cell disease who have had a kidney transplant and are~     immunosuppressed. If we can improve our scientific understanding of the fundamental~     mechanisms involved in patient outcomes, we can potentially maximize the benefits that we~     seek from transplantation in sickle cell patients with end stage renal disease.~   "
221196|NCT00663494|"~     The purpose of this study is to evaluate the production of MMP in failing hearts.~   "
221197|NCT00663481|"~     The purpose of this study is to determine the safety and tolerability of CoFactor in healthy~     subjects.~   "
221198|NCT00663468|"~     The purpose of this study is to determine the performance and efficacy during 6 and 12 month~     post operation.~        1. determine changes in patient pain level~        2. determine changes in patient functionality~        3. determine changes in patient life quality~   "
221199|NCT00663455|"~     The purpose of this study is to determine if a safe reduction of cyclosporine A in pediatric~     and adolescent patients with stable renal graft function, reduces signs of~     calcineurin-inhibitor toxicity.~   "
221200|NCT00663442|"~     Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA~     extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial~     with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS~     methylphenidate and placebo. Each week, parent report measures, clinical interviews, and~     safety assessments are conducted.~      Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype~     will predict response~   "
221201|NCT00663429|"~     This study is an extension study to the Callisto protocol CP-106. Subjects must have~     completed all 12 treatment cycles of CP-106 without disease progression as per RECIST~     criteria,to be eligible to to be enrolled in this study. This study will evaluate the safety~     and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine~     carcinoma who have metastatic or unresectable local-regional cancer and who have either~     symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or~     progression of neuroendocrine tumor(s).~   "
221202|NCT00663416|"~     Primary objective: To assess the neurological outcome in acute ischemic stroke patients~     treated with NTx™-265, when compared with patients given a placebo control.~      Secondary objective: To assess the safety and tolerability of NTx™-265 when given to acute~     ischemic stroke patients.~   "
221203|NCT00663403|"~     Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant~     microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU)~     considering the severity of illness and high risk for infection within this hospital~     environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of~     ICU patients who develop acute renal failure will require some form of renal replacement~     therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most~     common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer~     periods of time. The current data demonstrating the ability of continuous hemodialysis to~     remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is~     to determine the extent of daptomycin removal from critically ill patients receiving~     continuous hemodialysis. Findings from this trial will be used to develop new dosing~     recommendations for daptomycin in continuous hemodialysis.~   "
221204|NCT00663390|"~     The purpose of this study is to demonstrate the safety of the gynecological formulation in~     normal and usual usage condition of Dermacyd Delicata Pocket.~   "
221205|NCT00663377|"~     The purpose of this study is to evaluate the effects of losartan, an ARB, on glucose~     metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.~   "
221345|NCT00661557|"~     In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a~     previous study (whose objectives & outcome measures are presented in a separate protocol~     posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation~     technology.~      These subjects will be compared to subjects vaccinated with the new vaccine, but who were not~     previously vaccinated with a meningococcal polysaccharide vaccine.~   "
221206|NCT00663364|"~     Dry skin is a physiological condition and is characterized in contrast to greasy skin by~     roughness, desquamation and lack of brightness of the skin surface. Subjectively, feelings of~     tension, burning and itching can occur. Dry skin needs special care due to its structural and~     functional characteristics.We monitor an application test the Dermatocosmetics Oilatum~     Physiogel AI Lotion and Physiogel Lotion. This is to be accomplished with patients having dry~     skin. The influence on the roughness of skin, desquamation, feeling of tingle, burning and~     itching should be documented. If sleep quality is disturbed by tingle or itch, this will be~     monitored, too.~   "
221207|NCT00663351|"~     This Post-Approval study is prospective follow-up study designed to evaluate the long-term~     safety and effectiveness of the Reflection Ceramic Acetabular System.~   "
221208|NCT00663338|"~     The aim of this study is to assess the effect of the drug rotigotine on the syndrome of~     hemispatial neglect and motor deficits following strokes affecting the right hemisphere of~     the brain.~   "
221209|NCT00663325|"~     The purpose of this study is to demonstrate the safety of the gynecological formulation in~     normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.~   "
221210|NCT00663312|"~     Parkinson' disease is a neurodegenerative disorder characterised by bradykinesia, rigidity,~     rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine~     agonists usually leads to a dramatic improvement of symptoms, but disease progression~     nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus~     (STN) leads to a spectacular clinical improvement in patients with motor complications and is~     now considered as the gold standard surgical treatment.~      However, this surgery induces a post-operative body weight gain which may limit the benefits~     of this technique and induce critical metabolic disorders such as profound alterations in the~     central control of energy metabolism. Previous data seems to show that glucose metabolism is~     also altered.~      The aim of this prospective study was to identify if the STN stimulation could modify glucose~     metabolism regulation especially the endogen glucose production (by liver) Hypothalamus is~     able to detect glucose concentration variations and to control/adjust glucose levels by~     modulating the hepatic glucose production. As hypothamus and STN are anatomically closed, we~     hypothesise that the STN stimulation could modulate the hypothalamus function and~     consequently modify glucose production.~   "
221211|NCT00663299|"~     To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the~     treatment of aneurysms.~   "
221212|NCT00663286|"~     The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with~     acne vulgaris.~   "
221213|NCT00663273|"~     The purpose of this study is to demonstrate the safety of the gynecological formulation in~     normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.~   "
221214|NCT00663260|"~     The purpose of this study is to determine whether dapagliflozin is effective in the treatment~     of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment~   "
221215|NCT00663247|"~     Diverticulosis (bulges in the bowel wall) affects two third of the elderly population in the~     UK. Diverticular disease and its complications are responsible for 68000 hospital admissions~     and 2000 deaths per year. It commonly produces recurrent short lived abdominal pain, changes~     in bowel habit and incontinence. The causes of symptoms are not known and the treatments~     unsatisfactory. Recent studies have found an association between inflammation, alteration of~     bowel nerves and symptoms. Mesalazine is an anti-inflammatory drug used in inflammatory bowel~     conditions, such as ulcerative colitis and crohn's disease. We plan to perform a randomized~     double blind (neither the patients or the doctors known which treatment the patient is~     taking) placebo (sham medication) controlled trial of mesalazine in symptomatic diverticular~     disease patients. We anticipate a reduction in the amount of inflammation, bowel nerve~     changes and symptoms in patients taking mesalazine compare to those taking the placebo.~   "
221216|NCT00663234|"~     Treatment of HIV with combination antiretroviral regimens frequently results in the~     suppression of HIV viral load, significant immune recovery, and delayed disease progression.~     However, treatment with these regimens, particularly protease inhibitors (PIs), has been~     associated with significant increases in cholesterol and triglycerides in HIV-infected adults~     and children. The purpose of this study was to evaluate the safety and effectiveness of~     escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and~     triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.~   "
221217|NCT00663221|"~     We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone~     reshaping in menopausal women.~   "
221218|NCT00663208|"~     The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during~     dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C~     infection~   "
221219|NCT00663195|"~     The purpose of this study is to evaluate the effects of spironolactone on circulating MMP~     levels and insulin resistance in patients with chronic heart failure.~   "
221220|NCT00663182|"~     The aim of this study is to evaluate the effect of Entecavir for patients With decompensated~     HBV-Related cirrhosis.~   "
221221|NCT00663169|"~     This is an exploratory proof-of-concept study to evaluate the safety and efficacy of~     canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.~   "
221222|NCT00663156|"~     This research study is to evaluate the natural history of fat transplanted from a person's~     body to their breasts. We are seeking a natural, safe, and effective alternative to breast~     implants. Patients will undergo liposuction of their body followed by infiltration of this~     harvested fat around their breasts. The study protocol will involve preoperative and~     postoperative photographs, mammograms, and MRI to look for changes in the breast shape and~     size, as well as any internal changes in the breast tissue.~   "
221223|NCT00663143|"~     Thiazolidinediones (TZDs) are a commonly used antidiabetic drugs currently used by over a~     million patients in the United States. Recent studies have shown that treatment with TZD may~     increase the risk of bone fractures. The cause of bone loss is not known. We believe that TZD~     may cause increased accumulation of fat in the bone marrow, which may cause decrease bone~     formation and weak bones. .~   "
221224|NCT00663130|"~     Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes~     post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe~     ED~   "
221225|NCT00663117|"~     It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the~     bowel and quality of life in subjects with active Crohn's disease compared to placebo. In~     order to test this hypothesis the following specific aims are proposed:~        1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of~          Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain~          assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and~          quality of life surveys;~        2. Examine the effects of naltrexone given over 3 months compared to 6 months for~          durability of response;~        3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's~          disease, and~        4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin~          levels of subjects on therapy.~      Purpose statement: The purpose of this study is to evaluate the effects of low dose~     naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this~     compound in those with active Crohn's disease.~   "
221226|NCT00663104|"~     The aim of the study is to compare the effect of a progressive, periodized exercise training~     designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined~     effect of exercise and phytoestrogen (cimicifuga racemosa; CR). After randomization, 84~     females 1-3 year postmenopausal with no medication or illness affecting bone metabolism~     exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control.~     Three group training sessions/week will be performed in the EG. Both groups will be~     individually supplemented with calcium and Vit-D (cholecalciferol).~   "
221227|NCT00663091|"~     To test safety and efficacy of Bacteriophage on Venous Leg Ulcers.~   "
221228|NCT00663078|"~     The purpose of this study is to develop a structured CBT group intervention for women with~     depression of mild or moderate severity and to pilot a randomized controlled trial to compare~     this intervention with usual care in socially deprived areas in Bristol, incorporating~     qualitative methods to assess acceptability.~   "
221229|NCT00663065|"~     This is study to determine the safety of PAZ-417 in healthy adults over 65.~   "
221230|NCT00663052|"~     The purpose of this study is to compare the safety and efficacy of different doses of~     etanercept for the treatment of moderate to severe psoriasis.~   "
221231|NCT00663039|"~     Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom~     domains and functional impairments. Existing treatments of schizophrenia, although effective~     against positive symptoms, fail to benefit negative symptoms, the focus of the current~     protocol. One of the strategies of novel drug development depends on identifying heritable~     physiological deficits that mark the disease liability and are thought to occur along the~     causal pathway of negative symptoms. These heritable physiological deficits are often found~     in the biological relatives of schizophrenia proband; particularly those who have~     schizophrenia related personality styles [defined by schizophrenia spectrum personalities~     (SSP) in the diagnostic system], even though they do not have the full-blown illness. The~     current protocol will pilot a strategy of targeting biomarkers of negative symptoms using~     intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such~     non-clinical sample have several advantages including the absence of other drug treatment~     that may modulate the response, and the lack of generalized deficits causing problems with~     task comprehension/engagement that may mute the therapeutic signal. In addition, finding of~     efficacy of the experimental drug on the target physiological deficit and the associated~     symptoms has clinical implications on its own rights. This is because about 25% of subjects~     with schizophrenia spectrum personality disorders experience serious functional impairments.~      Oxytocin is an extensively used drug, which is well tolerated with few serious side effects.~     Several lines of evidence suggest its putative role in the treatment of negatives symptoms,~     particularly a lack of social drive and related symptoms.~   "
221232|NCT00663026|"~     The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of~     mild to moderate Alzheimer disease. Subjects will be in the study for six months and will~     receive subcutaneous injections once per week.~   "
221233|NCT00663013|"~     The investigators propose to study the effects of virtual reality (VR) on patients' pain~     perception during burn wound care. Such variables include psychiatric diagnosis and standard~     pain coping (i.e. pain catastophizer vs. non-pain catastrophizer).Aims: The investigators~     intend to evaluate the use of virtual reality in pain distraction for burn patients~     undergoing burn wound care. To that end our aims are: 1) To determine if pain perception will~     be less during the portion of the procedure in which the patient is immersed in the VR~     session in comparison to the portion of wound care which will occur without VR immersion. 2)~     To determine if anticipatory anxiety will be less for the portion of wound care that includes~     the virtual reality in comparison to the portion without virtual reality. 3) To determine if~     current psychiatric diagnosis, especially acute stress disorder and depression, is related to~     higher pain perception and greater decrease in pain with the virtual reality distraction. 4)~     To determine if being a pain catastrophizer is related to higher pain perception and~     greater benefits from the~   "
221234|NCT00663000|"~     Observational, Cross-sectional, longitudinal, multi-center, diagnostic study~      Cross-sectional part of the study: To evaluate the influence of acromegaly on glucose~     tolerance~      Longitudinal part of the study: To evaluate the changes of impaired glucose tolerance during~     standard treatment of acromegaly. Adult patients with established acromegaly~      Cross-sectional part of the study: 150 patients~      Longitudinal part of the study: 58 patients~   "
221235|NCT00662987|"~     To determine whether a 3-day course of postoperative antibiotics is effective as a 7-day~     course in reducing pain and reducing time to resumption of normal diet and activity following~     pediatric tonsillectomy~   "
221236|NCT00662974|"~     In this study we intend to randomly assign each parturient one of two commonly used oils to~     be applied during the second stage of labor, one of them containing vitamin E. We will verify~     if perineal massage increases the chances of delivering with an intact perineum comparing the~     two oils. As secondary objectives, we will evaluate the effects of perineal massage on~     specific tear location, the severity of perineal tears and the amount of suture material~     required for repair.~   "
221237|NCT00662961|"~     To compare periosteum versus bone fixation in forehead lift.~   "
238605|NCT00432185|"~     The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005~     Topical Gel for the treatment of superficial basal cell carcinoma on the trunk~   "
221239|NCT00662935|"~     The aim of this study is to evaluate the efficacy and safety of deep brain stimulation (DBS)~     in chronic and treatment-resistant CH. Inclusion criteria are: patients with chronic CH~     (>3years), with daily attack and non response to adequate treatment. Electrodes are implanted~     stereotactically in the postero-inferior hypothalamus. In this crossover, randomized,~     placebo-controlled double-blinded study, the efficacy of DBS is evaluated using comparison of~     two one-month sequences: one with stimulation on and the other with stimulation off~     (placebo sequence). Efficacy is defined as ≥50% decrease of weekly frequency of CH attacks.~     After the randomized period, long-term efficacy and safety are evaluated after one year of~     stimulation in open conditions.~   "
221240|NCT00662922|"~     Hypoglycemia occurs frequently during intensive blood glucose control in critically ill~     patients. The incidence of hypoglycaemia is associated with impaired outcome. However, it is~     hitherto unknown if hypoglycaemia itself predisposes patients to neurological impairment,~     e.g. cognitive dysfunction, or if it is the underlying medical condition that makes the~     patient prone to a high risk of hypoglycaemia and, concomitantly, neurocognitive impairment.~     Therefore we investigate neurocognitive function in patients who had hypoglycemias during~     their intensive care stay and compare the results to patients without hypoglycaemia whose~     medical conditions are matched to the hypoglycaemia patients.~   "
221241|NCT00662909|"~     The study is intended to test the efficacy, safety and tolerability of two doses of~     mirabegron against placebo to treat patients with symptoms of overactive bladder~   "
221242|NCT00662896|"~     To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in~     patients with osteoarthritis and controlled essential hypertension~   "
221243|NCT00662883|"~     To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal~     absorption of PMI-150 (intranasal ketamine HCl)~   "
221244|NCT00662870|"~     This study was designed to assess the lot comparability of DAPTACEL, as well as the safety~     and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.~      Stage I Primary Objectives:~        1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered~          with other recommended vaccines.~        2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of~          DAPTACEL when co-administered with other recommended vaccines.~        3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB~          concurrently administered in a different injection site with DAPTACEL when these~          vaccines are co-administered with other recommended vaccines.~      Stage II Primary Objectives:~        1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib~          or other infant vaccines.~        2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when~          co-administered with ActHIB in toddlers.~   "
221245|NCT00662857|"~     28 subjects to be enrolled for a screening period, 3 dosing visits & a follow-up visit.~     Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one~     30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin~     analogue).~   "
221246|NCT00662844|"~     That on average it will require a vitamin D dose of 1700IU/day to increase the serum~     25hydroxyvitamin D level from 20 to 30ng/ml in young Caucasian women and a dose of 1860 to~     2480 IU/day in African American~   "
221247|NCT00662831|"~     The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot~     ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area~     including intact skin healing.~   "
221248|NCT00662818|"~     The purpose of this study is to evaluate the safety and efficacy of telcagepant in the~     treatment of acute migraine in participants with stable vascular disease.~     Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The~     primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.~   "
221249|NCT00662805|"~     Primary objective: Evaluation of the safety of Seretide discus administration in subjects~     with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1),~     treatment phase (visits 2-5. In the case of AE, there will be another visit (visit 6) as a~     follow up visit - follow up phase.~   "
221250|NCT00662792|"~     The primary objective of this trial is to establish superiority of the once-daily Tiotropium~     plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in~     night-time lung function response over the comparator treatments inhaled in their established~     dose regimens when administered for 6-week periods to patients with chronic obstructive~     pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the~     Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.~   "
221251|NCT00662779|"~     It is our primary hypothesis that pretreatment with arformoterol will provide superior~     protection against EIB in children with mild-moderate asthma compared to placebo added to the~     current asthma regimen.~      Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB~     compared to inhaled formoterol by dry powder inhaler.~   "
221252|NCT00662766|"~     The study was performed to investigate the effects of the consumption of black currant seed~     press residues, which were baked into bread.~   "
221253|NCT00662753|"~     The purpose of this study is to determine if the use of home blood pressure monitors plus~     nurse telephone monitoring is more effective than the use of blood pressure monitors alone in~     improving control of high blood pressure in an urban medical clinic.~   "
221254|NCT00662740|"~     The primary objectives of this study are to assess bronchodilator efficacy as determined by~     FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as~     determined by the SGRQ and the effect on COPD exacerbations.~   "
221255|NCT00662727|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients~     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.~   "
221256|NCT00662714|"~     Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections~     with respect to blood glucose control, weight and pulmonary function over 2 years in patients~     with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the~     phase III trial.~   "
255543|NCT00205933|"~     The purpose of this project is to use behavioral techniques to investigate emotional~     processing in subjects with major depression and healthy comparison subjects.~   "
221257|NCT00662701|"~     The purpose of this study is to compare 2 invasive strategies for Atrial Fibrillation~     treatment, Endocardial catheter ablation isolation of the Pulmonary veins versus minimally~     invasive thoracoscopic surgical epicardial isolation. Both strategies are in use for several~     years now, and have been reported as a successful strategy with success rates of 60-90%.~     However, it is not known which technique is preferable in a given patient population in terms~     of efficacy to cure AF, safety, or patient discomfort. Therefore, in the present trial a~     randomized study is proposed to provide more insight into the relative merits of both~     techniques~   "
221258|NCT00662688|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from~     forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine~     is more effective when given alone or together with dalteparin and/or capecitabine in~     treating patients with pancreatic cancer.~      PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots~     in patients with pancreatic cancer receiving treatment with different combinations of~     gemcitabine and capecitabine.~   "
221259|NCT00662675|"~     The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT~     in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with~     clinical symptoms of exocrine pancreatic insufficiency (EPI).~   "
221260|NCT00662662|"~     The goal of this behavioral research study is to learn if certain sexual behaviors increase~     the risk for developing head and neck cancers associated with a virus called human~     papillomavirus (HPV-16). Knowing this information could help doctors better teach patients~     about avoiding certain risk factors, which may help to prevent the disease.~   "
221261|NCT00662649|"~     This extension study of was designed to evaluate the long-term safety, tolerability, and~     efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was~     an extension to the 24-month Core study (CFTY720D2301/NCT00289978).~   "
221262|NCT00662636|"~     RATIONALE: Dasatinib and lapatinib ditoslylate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib and~     lapatinib ditoslylate when given together in treating patients with advanced solid tumors~     that cannot be removed by surgery.~   "
221263|NCT00662623|"~     The purpose of this study is to examine the effect of different methods of providing~     education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and~     how that education might help to improve health outcomes and the amount of time CPAP is used.~   "
221264|NCT00662610|"~     To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with~     osteoarthritis and controlled essential hypertension~   "
221265|NCT00662597|"~     The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the~     cancer treatment more effective in patients with advanced lung cancer.~   "
221266|NCT00662584|"~     Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method that holds~     promise for treating several psychiatric disorders. Yet the most effective location and~     parameters for treatment need more exploration. Also, whether rTMS is an effective treatment~     for individuals with a DSM-IV diagnosis of Generalized Anxiety Disorder (GAD) has not been~     empirically tested. The goal of this pilot study is to evaluate whether fMRI guided rTMS is~     effective in reducing symptoms of GAD.~   "
221267|NCT00662571|"~     In 2004, acamprosate was approved in the U.S. for abstinence maintenance, by decreasing~     craving, in alcoholic patients who have undergone detoxification. while a new anti-craving~     drug was encouraging, only 36.1% of the subjects treated with acamprosate remained abstinent~     for 6 months. Having the ability to identify treatment responsive individuals would have a~     major impact on the use of acamprosate.~   "
221268|NCT00662558|"~     To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low~     Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6~   "
221269|NCT00662545|"~     This study will evaluate HIV-HBV infected individuals who have evidence of HBV replication in~     the blood after taking 48 weeks of more of the HBV active medication tenofovir in combination~     with emtricitabine or lamivudine. Eligible participants will be randomized to receive 24~     weeks of entecavir (ETV) 1 mg versus continued standard of care antiretroviral therapy. After~     24 weeks, individuals on entecavir or who remain HBV viremic on standard of care will receive~     ETV o for an additional 24 weeks. The hypothesis is that intensification with entecavir will~     reduce HBV DNA at 24 weeks more than continued antiretroviral therapy without entecavir.~   "
221270|NCT00662532|"~     This study is for people at least 21 years old who have signs of problems, like swollen gums~     and shrinking bones, by dental implants.~   "
221271|NCT00662519|"~     The primary purpose of this study is to find out if giving a 12 week course of Neulasta~     (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D)~     is safe. The secondary purpose of this research study is to determin if giving GCSF to~     patients with T1D changes the immune system or preserves insulin production.~   "
221272|NCT00662506|"~     This phase I/II trial is studying the side effects and best dose of cediranib to see how well~     it works when given together with temozolomide and radiation therapy in treating patients~     with newly diagnosed glioblastoma. Cediranib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs~     used in chemotherapy, such as temozolomide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Giving cediranib together with temozolomide and~     radiation therapy may kill more tumor cells.~   "
221273|NCT00662493|"~     Pain at the front of the knee is a common condition treated by physical therapists. Treatment~     may consist of generalised strengthening exercises directed at the quadriceps muscle or~     specific retraining aimed at restoring motor control at the knee. This study compared these~     two exercise programs in a group of people who were painfree at the time to evaluate their~     effect on motor control. It was hypothesised that only the motor retraining program would~     influence motor control at the knee.~   "
221274|NCT00662480|"~     Well-documented health benefits may be achieved through prophylactic screening for~     cardiovascular disease. The advantages are fewer premature deaths and a reduction in the~     number of hospital admissions and amputations. Furthermore, hospitals will benefit from the~     derived reduction in the pressure on surgery and intensive care capacities at vascular~     surgery departments.~      It therefore seems extremely relevant to offer joint screening for abdominal aortic aneurysm,~     peripheral arterial disease and hypertension, even if the benefit and costs of such a measure~     are not currently known.~      Consequently, the primary objective of the study is to establish the effect and~     cost-efficiency of a joint circulation screening programme for 40,000 men aged 65-74 years in~     a randomised, clinically controlled study.~      The project manager will train six nurses to measure ABI and perform ultrasound scans of the~     aorta. The nurses form three teams which will each be equipped with a portable Doppler, blood~     pressure cuff and portable ultrasound scanner. Each team will operate from the hospitals in~     the Region. Civil registration number (in Danish: CPR), name and address information will be~     supplied by the Clinical Epidemiological Department (CED), which will also perform the~     randomisation in groups of approx. 1,000 to avoid too long a period from data extraction to~     invitation. Half of the randomised subjects will be invited to participate in a circulation~     examination focused on PAD, AAA and hypertension, while the other half will be controls Men~     with positive findings are informed and proper preventive actions is taken. Annual controls~     are offered, and AAA exceeding 5.5 cm in diameter is offered operation.~      The primary efficiency variables are death, cardiovascular death and AAA-death. The secondary~     efficiency variables are hospital services related to cardiovascular conditions and costs for~     such services in accordance with current DRG rates.~      The entire population, the controls as well as the screening group, will be monitored for a~     period of 10 years. Information concerning deaths, including date of death, is obtained from~     the Civil Registration System, information on visits to outpatient clinics and hospital~     admissions caused by cardiovascular conditions including amputations is obtained from the~     National Patient Registry. From the Danish Causes of Death Registry information on cause of~     death is collected. The information is classified with regards to cause; AAA or~     cardiovascular. The cardiovascular interventions are identified in the vascular surgery~     database (Karbasen). Major follow-up is performed at 3, 5 and 10 years.~      A steering and data validation group will be formed including the project manager and a~     representative from the Clinical Epidemiology Department. Furthermore, a vascular surgeon~     from each of the two affected departments in the region will participate.~      Total mortality, cardiovascular and AAA-related mortality and initial cardiovascular hospital~     service are compared for the two groups using Cox proportional hazards-regression analysis~     which facilitates description of the risk ratio. The cost-efficiency calculation will be~     adjusted for quality of life.~   "
221275|NCT00662467|"~     Following severe heart attacks involving the front wall of the heart (anterior myocardial~     infarction), patients are at risk of developing blood clots in the main pumping chamber that~     can cause a stroke. In the past, studies have shown that a blood thinner (warfarin) can~     decrease the risk of stroke and clot formation if administered to patients after an anterior~     myocardial infarction.~      However, in today's current practice, certain heart attack patients are commonly treated with~     two blood-thinning medications (aspirin and clopidogrel) to prevent recurrent heart attacks.~      Thus, a clinical problem is created as physicians are not clear how to treat patients after~     an anterior myocardial infarction who are at risk of a clot but require aspirin and~     clopidogrel to keep their blood vessels open. Adding warfarin to the combination of aspirin~     and clopidogrel will possibly decrease the risk of stroke but increase the risk of bleeding.~     Currently, there is no good evidence to help guide physicians. As demonstrated by a survey~     done at the Hamilton Health Sciences, there is a fifty/fifty split between physicians who use~     dual (aspirin and clopidogrel) versus triple (aspirin, clopidogrel, and warfarin) therapy in~     the treatment of similar patients as described above.~      The purpose of this study is to address the bleeding and stroke complications in patients~     after a severe anterior myocardial infarction. Half of the eligible patients will receive~     dual therapy and half will receive triple therapy. We will compare the incidence of stroke,~     blood clots, and bleeding complications between the two groups at 3 months.~   "
221276|NCT00662454|"~     The purpose of the blood spot validation portion of the study is to test if measuring female~     hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw~     from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two~     populations of oral contraceptive users: heavier and lighter women.~   "
221277|NCT00662441|"~     Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection~     sufficient for satisfactory sexual performance. An ideal treatment option should be effective~     and reliable, have minimal side effects, be simple to use and affordable. The purpose was the~     evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile~     Dysfunction (ED).~   "
221278|NCT00662428|"~     The cost-effectiveness of a new, guideline oriented sequential inpatient - outpatient~     treatment model will be investigated. Secondary outcomes are: patient satisfaction,~     practitioners' satisfaction and influence on work.~   "
221279|NCT00662415|"~     Almost everyone who has a traumatic limb amputated will experience a phantom limb - the vivid~     impression that the limb not only still is present, but also in many cases, painful.~     Preliminary data from study WRAMC WU# 05-71034, Pilot study to assess the efficacy of~     mirror-box and mental visualization treatments on phantom limb pain demonstrates that 4~     weeks of mirror therapy is effective for treating phantom limb pain (PLP) and suggests that~     vision is a key component modulating PLP and may be the explanation for the efficacy of~     mirror therapy, as subjects view the reflected image of their intact limb while attempting to~     move the amputated, or phantom, limb. We propose conducting a study using functional magnetic~     resonance imaging (fMRI) to identify brain regions critical for the mirror effect and to~     study the relationship of visual activation to the sensation of phantom pain. Subjects will~     have an fMRI scan prior to starting therapy, 2 weeks after starting mirror therapy and again~     after 4 weeks of mirror therapy. Data will be gathered daily on the number of episodes of~     phantom limb pain, the average length of episodes, and the average intensity of pain.~   "
221280|NCT00662402|"~     In this study we wish is to determine whether extensive (up to 15 hours) multidisciplinary~     consultation in biostatistics, study design, data management, ethics, and writing provided by~     the UCSF Clinical and Translational Science Institute's (CTSI) Consultation Services program,~     improves peer review scores of career development grants compared to usual levels of~     consultation.~      We hypothesize that extensive multidisciplinary consultation will improve peer review scores~     of career development grants compared to usual levels of consultation.~      We hypothesize that extensive multidisciplinary consultation will lead to greater numbers of~     funded grants when compared to the usual levels of consultation.~   "
221281|NCT00662389|"~     The purpose of this feasibility study is to gain an initial assessment of the acute safety~     and performance of the Apsara Thermal Wand System in human facial tissue.~   "
221282|NCT00662376|"~     The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects~     of the oral nutritional supplement (PreOP Booster) given to patients prior to~     gastrointestinal surgery.~   "
221283|NCT00662363|"~     Patients requiring opioids for post-operative pain control following elective orthopedic~     procedures which has resulted in constipation symptoms, and who are in inpatient~     rehabilitation will be randomized to two different treatment arms: lubiprostone or senna.~     Baseline scores regarding constipation and a quality of life bowel questionnaire will be~     compared the day following 6 days of treatment intervention.~   "
221284|NCT00662350|"~     To measure intra-prostatic temperatures and evaluate the shape and size of necrotic lesions~     achieved under the standard treatment protocol in men with benign prostatic hyperplasia~     (BPH).~   "
221285|NCT00662337|"~     The purpose of this study is to determine if two formulations of diphenhydramine~     hydrochloride are bioequivalent.~   "
221286|NCT00662324|"~     The purpose of this study is to develop a Question Prompt List (QPL) about clinical trials~     for cancer patients and find out what cancer patients and their caregivers think of the QPL.~     A QPL is a list of questions patients might want to ask their doctors during their~     appointments.~      We will conduct three focus groups to talk about using QPL's as a new way to recruit patients~     like you to clinical trials. The three groups will be made of patients who have and have not~     participated in clinical trials, their caregivers and doctors. This study is also being done~     to learn about how the QPL affects the question asking behavior of patients during their~     appointments with doctors at Memorial SloanKettering Cancer Center (MSKCC).~   "
221340|NCT00661622|"~     Patients with uveal melanoma metastatic to the liver will be treated with embolization of the~     hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or~     normal saline will be injected into one of the liver arteries with an oily contrast dye,~     Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge~     (embolization). It is hoped with this novel approach that:~        -  tumor cells will die due to a loss of their blood supply,~        -  local inflammatory reactions induced by GM-CSF will kill remaining tumor cells, and~        -  a systemic immune response against tumor cells may develop.~   "
221287|NCT00662311|"~     This phase I/II trial studies the side effects and best dose of vorinostat when given~     together with paclitaxel and radiation therapy and to see how well it works in treating~     patients unable to tolerate cisplatin with stage III non-small cell lung cancer (NSCLC) that~     cannot be removed by surgery. Vorinostat may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving vorinostat together with paclitaxel and radiation therapy may kill more tumor cells~   "
221288|NCT00662298|"~     The purpose of the study is to evaluate whether severe asthmatic subjects have abnormal~     prednisolone absorption, and how this might affect the anti-inflammatory effects of~     prednisolone.~      The aims of the study are~        1. to compare the effect of high dose prednisolone on clinical and physiological responses~        2. to determine the effect of long-term oral prednisolone therapy on corticosteroid~          responsiveness and prednisolone pharmacokinetics~        3. to measure the effect of high dose prednisolone for 14 days on p38 MAPK activity, GR~          translocation and activation of NF-kB~        4. to validate an easier method of measuring corticosteroid insensitivity using whole~          blood, and a spot prednisolone serum level as a measure of adherence to prednisolone~          therapy~   "
221289|NCT00662285|"~     Description of the effect of standard iron supplement on iron status in blood donors~      Hypothesis:~      For each person in each group (group a without iron supplement or group b with iron~     supplement) individual biological variation in reticulocytes, tested day 1 and day 8 will be~     described. Groups a and b will be compared on iron status from day 1 and day 8.~        -  H1 null: There is no significant intraindividual difference in reticstatus at day 1 and~          at day 8, in group a.~        -  H2 null: There is no significant intraindividual difference in reticstatus at day 1 and~          at day 8, in group b~        -  H3 null: There is no significant difference in iron status for the two groups, a and b,~          at day 1 and at day 8.~   "
221290|NCT00662272|"~     This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine~     with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy~     adults 18-49 years of age.~   "
221291|NCT00662259|"~     The purpose of this study is to find out how an anti-anxiety drug or placebo affects the~     activity of your brain when you are at rest and when you are viewing emotional material, such~     as, emotional faces and pictures.~   "
221292|NCT00662246|"~     The radical treatment for Hepatocellular carcinoma (HCC) is surgery. However, it is only for~     10 to 20% of all patients and 10 to 30% of them have relapsed every year after surgery. For~     an inoperable case, we can consider Liver transplantation. But there is not enough organ~     donor and it is very expensive. In that case, various treatment modalities for HCC (i.e.,~     transcatheter arterial embolization [TAE] and percutaneous ethanol injection [PEI],~     radiofrequency ablation etc.) have become clinically available. In addition, after these~     treatment, radiation therapy can be conducted as a combined treatment. If it is difficult,~     radiation therapy can be conducted alone. In this case, radiation therapy can use~     fractionated stereotactic radiation therapy [FSRT] or 3D simulation to minimize the exposure~     to normal tissues. In recent years, Proton therapy is a new radiation therapy which remaining~     energy is released when they reach the tumor, delivering the most effective dose of~     radiation. The purpose of this trial is to improve the therapeutic effects by using proton~     therapy.~   "
221293|NCT00662233|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating~     patients with sarcoma.~   "
221294|NCT00662220|"~     Optimal ribavirin dosages are essential in achieving SVR (sustained virological response).~     Several studies have shown higher SVR rates in patients receiving higher doses of ribavirin.~     Therefore we propose a randomized controlled open label multicenter trial to investigate~     wether high (25-29mg/kg) dose ribavirin can improve outcome in patients in infected with~     hepatitis C virus genotype 1 or 4 compared to standard dose (12-15mg/kg).~   "
221295|NCT00662207|"~     The purpose of this investigation is to evaluate methods in spinal cord injured individuals~     to improve reflex urination. Anal dilation will be investigated to reduce high urethral~     resistance and a vibrator on the patient's bottom will be tested to induce more sustained~     bladder contractions for better bladder emptying.~   "
221296|NCT00662194|"~     Data from this study will provide the first information how the innate immune system may be~     altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor~     changes with HIV co-infection therapy.~   "
221297|NCT00662181|"~     A follow-up study on the randomized, controlled, double-blind HIGH: low study. We will~     examine the participants from the HIGH: low study min. 6 months after finishing the HIGH: low~     study. We will look at the parameters: quality of life, sugar-metabolism, fat-metabolism,~     fat-redistribution and cytokines. The study will use the participants control visit, and the~     only additional examination will be the danish MOS-HIV questionnaire.~   "
221298|NCT00662168|"~     This proposed pilot study is to conduct detailed interviews into the medical, environmental,~     and family histories The second phase of this study project is to and to collect blood~     specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers~     University Cell and DNA Repository (RUCDR) and stored for a second phase of this pilot. The~     purpose is to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate~     dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with~     different types of carcinoid cancer.~   "
221341|NCT00661609|"~     The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a~     novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor~     cell division leading to tumor growth), can reduce tumor sizes in patients with bladder~     cancer~   "
221342|NCT00661596|"~     Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The~     purpose of this national study was to determine if vardenafil is effective in treating~     impotent men (erectile dysfunction) and evaluate its influence in self-esteem and~     self-confidence. During the visits the patients was asked some questions about erections, and~     he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual~     activity.~   "
221299|NCT00662155|"~     The lack of scientific attention devoted to the placebo effect as a phenomenon in its own~     right probably reflects the paucity of theoretical positions within which to organize the~     existing data and design new research. The proposed investigation 1) is an attempt to advance~     from a descriptive to an experimental analysis of the placebo effect, taking into account~     classical conditioning effects, and 2) examines the clinical implications of partial~     reinforcement as it is applied to the treatment of insomnia. Subjects with primary insomnia~     will be treated with zolpidem for a period of one month and then randomized to one of four~     groups for a period of 12 weeks: one receiving full dose zolpidem on a nightly basis~     (continuous reinforcement), one receiving full dose zolpidem on 14 of 28 nights where placebo~     is provided on non-drug nights (partial reinforcement), one receiving full dose zolpidem on~     14 of 28 nights where no pills are imbibed on non-drug nights (intermittent dosing), and one~     receiving 5 mg dose zolpidem on a nightly basis (continuous reinforcement with half the~     standard dose). Following treatment, subjects will be entered into an extinction protocol~     during which they will 1) continue on the schedule assigned during the experimental period,~     2) receive only placebo, or 3) receive neither drug nor placebo. Sleep and daily functioning~     will be monitored on a daily basis via sleep diaries for the duration of the study. It is~     hypothesized that, holding cumulative dose constant, a partial schedule of reinforcement will~     enable patients to better maintain their clinical gains as compared to subjects that receive~     either continuous reinforcement with half the standard dose or half the frequency of use.~      Relevance: The proposed research is not an attempt to offer a behavioral alternative to drug~     treatment; it is an attempt to acknowledge and capitalize on a behavioral dimension in the~     design of drug treatment protocols. The value of the proposed research resides in its~     capacity to provide for the long term treatment of insomnia in a manner that increases the~     durability of pharmacotherapy while reducing the overall amount of medication required. If~     proven effective in the current application, this new approach to pharmacotherapy and placebo~     effects is likely to stimulate new interdisciplinary research for the treatment of a variety~     of chronic diseases.~   "
221300|NCT00662142|"~     The goal of this study is to determine if 8-week dietary treatment with the omega-3 fatty~     acid docosahexaenoic acid (DHA) improves attention performance and associated cortical~     activity and metabolism in 8 - 10 year old males that were not breast-fed during infancy.~   "
221301|NCT00662129|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized~     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving combination chemotherapy together with bevacizumab may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized~     nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients~     with metastatic breast cancer.~   "
221302|NCT00662116|"~     This study is being done to evaluate the safety and effectiveness of alagebrium in subjects~     diagnosed with diastolic heart failure. The primary assessment for effectiveness is the~     assessment of exercise tolerance.~   "
221303|NCT00662103|"~     RATIONALE: Aerobic exercise, resistance exercise, and flexibility and relaxation training may~     reduce fatigue and improve the health and quality of life of breast cancer survivors. It is~     not yet known which type of exercise is more effective for inactive older female breast~     cancer survivors.~      PURPOSE: This randomized clinical trial is studying aerobic exercise to see how well it works~     compared with resistance exercise or flexibility and relaxation training in improving the~     health and quality of life of inactive older female breast cancer survivors.~   "
221304|NCT00662090|"~     The aim of the study is to improve the accuracy of diagnosis for children and adolescents~     with MDS by a standardized review of morphology and standardized cytogenetic and molecular~     analysis.~      The primary objectives of the study are:~        -  To evaluate the frequency of the different subtypes of MDS in childhood and adolescence~          by a standardized diagnostic approach~        -  To evaluate the frequency of cytogenetic and molecular abnormalities:~      Specifically using array-CGH to evaluate the frequency of subtle chromosomal imbalances, i.e.~     gains and losses of defined chromosomal regions, and amplifications.~      Specifically using mFISH to identify unknown chromosomal aberrations, particularly subtle~     translocations involving new candidate genes, and to better define chromosomal breakpoints.~      The secondary objectives of the study are:~        -  To assess survival for children and adolescents with MDS and JMML~        -  To evaluate relapse rate, morbidity and mortality in children with MDS and JMML treated~          by HSCT~   "
221305|NCT00662077|"~     This project wills to determine the incidence of osteoporosis in our population of~     HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy~     in post-menopausal women has already been proved.~   "
221306|NCT00662064|"~     The function of the lower urinary tract is simple - urine storage and voiding. However,~     despite this simplicity of function, the control of the lower urinary tract is a rather~     complex, multilevel process (urothelium, detrusor, peripheral nerves, spinal cord and higher~     cerebral centres) and the mechanisms involved remain poorly elucidated.~      This study is designed to gain a more in depth understanding of the lower urinary tract~     function. Using bladder biopsies, tissue staining for characteristic markers present on~     nerves and other cells will be performed. We hypothesize that certain markers are altered in~     disease and turn back towards the control level of healthy people or patients with successful~     medical treatment.~   "
221307|NCT00662051|"~     Asthma is a chronic inflammatory disorder of the airways affecting approximately 15 million~     individuals in the U.S. The rate of asthma exacerbations among women is twice that of men~     after adolescence, and a large proportion of females with asthma report worsened asthma~     symptoms during different phases of the menstrual cycle. Hormonal influences have been~     hypothesized to account for these differences. Decreased peak flow rates and increased~     symptoms have been found in females during the premenstrual phase of the menstrual cycle when~     estrogen and progesterone levels are low. Estrogen and progesterone have both been found to~     reduce smooth muscle contractility and increase bronchial smooth muscle relaxation. A~     perimenstrual shift toward a Th2 (allergic) phenotype characterized by a decreased~     interferon-gamma to interleukin-10 ratio has been demonstrated in healthy women not using~     oral contraceptives compared to midcycle; however, the effect was blunted in healthy oral~     contraceptive pill users, implying hormonal modulation of the allergic phenotype. Several~     case reports have demonstrated a therapeutic benefit of oral contraceptives in decreasing~     asthma exacerbations and corticosteroid requirements. Human studies have demonstrated that~     estrogen decreases pro-inflammatory cytokine generation, neutrophil recruitment, and inhibits~     inducible nitric oxide synthase activity, which could lead to lower exhaled nitric oxide~     levels.~      The measurement of the fractional concentration of exhaled nitric oxide (FENO) is a~     non-invasive method to assess airway inflammation in adults and children with asthma. The~     hypotheses of the current study are that women using oral contraceptives will have lower FENO~     levels and better asthma control as assessed by the Asthma Control TestTM during different~     phases of the menstrual cycle. This study may identify clinically important changes in FENO~     levels and asthma control during the menstrual cycle and modification of these effects by~     oral contraceptive pills. This data may lead to future studies aimed at identifying~     therapeutic roles for hormones in asthma therapy in women.~   "
221308|NCT00662038|"~     This is an open-label, multi-center, extension study for patients with IPF who complete a~     qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain~     additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a~     qualifying InterMune clinical trial of pirfenidone.~   "
221309|NCT00662025|"~     To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese~     patients with advanced/metastatic breast cancer.~   "
221310|NCT00662012|"~     Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the~     world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a~     threat for military soldiers in areas where this disease is found. Sodium stibogluconate~     (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND)~     product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and~     viseral leishmanias. This drug is not licensed for commercial use in the United States~     because of very limited need for the product in the U.S.A. The objective of this protocol is~     to provide sodium stibogluconate for the treatment of cutaneous leishmaniasis and mucosal~     leishmaniasis (pentavalent antimonials curently considered the drug of choice for these~     infections) Provide sodium stibogluconate as a second line treatment for viscerotropic and~     visceral leishmaniasis (liposomal amphotericin is the drug of choice for these types as it is~     FDA approved for vusceral leishmaniasis).~   "
221311|NCT00661999|"~     RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells~     contain iron that is needed to carry oxygen to the tissues. It is not yet known whether~     giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective~     than giving darbepoetin alfa together with a placebo in treating anemia caused by~     chemotherapy.~      PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with~     iron to see how well it works compared with giving darbepoetin alfa together with a placebo~     in treating anemia caused by chemotherapy in patients with cancer.~   "
221312|NCT00661986|"~     Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial~     effect on arterial blood pressure in one previous study. The trial will assess if ingestion~     of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced~     effect. The population will consist of cardiovascular high-risk patients only (who will~     potentially benefit most from blood-pressure lowering).~   "
221313|NCT00661973|"~     The main objective is to evaluate how treatment with inhaled corticosteroids (ICS) affects~     the characteristics of airway smooth muscle (ASM) cells from asthmatic subjects. Our~     hypothesis is that airway smooth muscle cell dysfunction plays an important role in the~     pathogenesis of asthma, and that treatment with inhaled corticosteroids reverses the~     abnormalities in airway smooth muscle cell function.~   "
221314|NCT00661960|"~     This research is being done to study how the immune system in the small intestine improves~     after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the~     increase in the numbers of immune cells in the intestine to see if one type of HIV medication~     gives different results than other types of HIV medications.~   "
221315|NCT00661947|"~     The purpose of this study is to determine whether sucrose vs high fructose corn syrup from a~     soft drink results in differences in various metabolic byproducts such as fructose, glucose,~     serum uric acid, triglyceride and lactate.~   "
221316|NCT00661934|"~     The study goal is to investigate the effect of dialysis/medicinal treatment on cardiac~     function and heart sounds by recording heart signals from the chest wall.~   "
221317|NCT00661921|"~     The purpose of this study is to investigate the effects of blocking IL-1 signaling with AMG~     108 in type 2 diabetes mellitus patients on glycemic control, as measured by change in HbA1c~     from baseline to end of treatment (EOT).~   "
221318|NCT00661908|"~     Diabetic subjects often report of problems at the workplace or when contracting insurances~     because of their diabetes.~      By distributing a self-report questionnaire to insulin-treated Type 1 and Type 2 diabetic~     subjects we wanted to analyse the frequency of work- and insurance-related discrimination.~     Furthermore we wanted to detect socio-demographic and diabetes-related factors which are~     associated with increased discrimination at workplace and by insurances. We hypothesized that~     diabetes-related discrimination at workplace and by insurances exists and that certain~     factors like having severe hypoglycaemic events, being type 1 diabetic or being overweight~     would be associated with more problems at work or with insurances.~   "
221319|NCT00661895|"~     Clinical trials have yet to test the adequacy of HTN control in African Americans (AA) when~     both control and intervention groups are given free antihypertensive medications and are~     involved in usual versus intensive intervention strategies. Because of this, it has not yet~     been determined whether the method of prescribing antihypertensive medications according to~     JNC 7 guidelines is more, less, or equally as effective as prescribing antihypertensive~     medications and providing intensive behavioral and clinical interventions. Knowledge in this~     area of HTN treatment should better able medical and health practitioners to help their AA~     subjects control HTN. The BEAT Hypertension Clinic will evaluate this method of HTN control~     by proposing a program that will evaluate the difference in HTN control among subjects~     receiving usual care and free medications and subjects also receiving free medications, but~     additionally being treated in a clinic that operates in a more intensive manner in~     relationship to patient behavior modification, patient-clinician interactions, and physical~     and social environments. At the conclusion of the study, the BEAT Hypertension Clinic~     investigators will report findings and help to answer the question of whether medication~     alone or medication combined with intensive behavioral and clinical treatment is more~     effective in HTN control in the AA population.~   "
221320|NCT00661882|"~     RATIONALE: Gathering information about patients with cancer may help doctors learn more about~     the disease and plan early diagnosis and treatment.~      PURPOSE: This clinical trial is studying computer tools for improving early diagnosis and~     treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a~     non-cancerous pancreatic disorder.~   "
221321|NCT00661869|"~     Obesity is increasing at an alarming rate in patients with schizophrenia, possibly in~     association with the increased use of atypical antipsychotics. In order to address the weight~     and metabolic syndrome issues, Manhattan Psychiatric Center (MPC) has implemented the~     Solutions for Wellness and Team Solutions Program. This program is designed to create a~     supportive, educational and monitoring environment to stabilize both the psychiatric and~     medical conditions and to prepare patients for independent management of their psychiatric~     and physical health condition in the community.~   "
221322|NCT00661856|"~     The aim of the present study was to investigate the effects of soy and soy plus isoflavones~     on bone mineral Density and physical performance in post menopausal women.~   "
221343|NCT00661583|"~     The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs~     monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.~   "
221324|NCT00661830|"~     This trial will be conducted to evaluate the efficacy, safety and tolerability of a~     combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a~     first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong~     scientific rationale for exploring the role of sorafenib in combination with gemcitabine in~     advanced CCC.~      Sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and~     angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the~     receptor tyrosine kinases VEGF-R2, R3 and PDGFR-β.~      Mutations in these signaling pathways display by far the most common genetic alterations in~     CCC and overexpression correlates to poor prognosis. Furthermore, there is no evidence of a~     consistent or meaningful pharmacokinetic interaction between sorafenib and gemcitabine,~     suggesting that sorafenib can safely be combined with gemcitabine.~      Clinical results of a combination of sorafenib and gemcitabine in a phase I study in~     pancreatic cancer suggested a therapeutic effect, and the safety and efficacy results~     together with the knowledge of the molecular pathology of CCC provide a rationale for a~     randomized, placebo-controlled phase II trial consisting of gemcitabine plus sorafenib in~     advanced CCC.~   "
221325|NCT00661817|"~     Obesity is a serious health problem that is a contributing factor for heart disease and high~     blood pressure. This study will evaluate a lifestyle modification program that aims to~     encourage weight loss and improve the health of people with high blood pressure from low~     income and minority communities.~   "
221326|NCT00661804|"~     Thalassemias are inherited blood disorders that can cause anemia and other health problems.~     The goal of this study is to collect information on complications of the disease among people~     who currently have or previously had thalassemia.~   "
221327|NCT00661791|"~     The purpose of this study was to determine whether massage with or without physical exercise~     impacted weight gain or length of hospital stay for premature infants.~   "
221328|NCT00661778|"~     This study assessed the efficacy and safety of Avastin in combination with docetaxel and~     cisplatin as first-line treatment of patients with metastatic or locally advanced non-small~     cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2,~     and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.~   "
221329|NCT00661765|"~     1. To evaluate the absorption and elimination of varenicline Formulation A transdermal~          delivery system [TDS (patch)] compared to varenicline immediate release tablet~          (CHANTIX®).~        2. To evaluate the adhesion of the varenicline Formulation A patch.~        3. To evaluate the safety and tolerability of a single application of the varenicline patch~          and a single oral dose of the varenicline immediate release tablet (CHANTIX®).~   "
221330|NCT00661752|"~     A new, innovative software image processing method, wide beam reconstruction (WBR), utilizes~     resolution recovery and incorporates Poisson noise-reduction into the reconstruction process~     of NM images. This method facilitates the reconstruction of low count density myocardial~     perfusion SPECT images. Preliminary research indicates that SPECT acquisition time~     consequently can be reduced by 60% (less than 5 minutes) for rest and by 75% (just over 3~     minutes) for stress, while tomographic image quality is maintained, or even improved. Such a~     decrease in image acquisition time decreases patient discomfort during the tomographic~     acquisition, decreases the opportunity for patient motion, and improves laboratory~     efficiency.~   "
221331|NCT00661739|"~     The aim of the study is to establish a feasible combination of bendamustine and paclitaxel in~     a weekly schedule. The two agents have different toxicity profiles and are well tolerated~     when given in a weekly fashion. The combination might be of special interest for elderly~     patients with hormone insensitive breast cancer~   "
221332|NCT00661726|"~     Thalassemia intermedia (TI) is an inherited blood disorder that can cause anemia due to low~     levels of hemoglobin. Decitabine is a medication that may be effective at increasing~     hemoglobin levels. This study will evaluate the safety and effectiveness of decitabine at~     increasing hemoglobin levels in people with TI.~   "
221333|NCT00661713|"~     The proposed study is aimed to assess the antibody response and short-term persistence of~     Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal~     vaccination schedule in an adolescent population.~   "
221334|NCT00661700|"~     To find out more information on how treating impotence with vardenafil in comparison to~     placebo affects the quality of life (QoL) of men and their partners. Subjects will receive~     10mg vardenafil or placebo for 4 weeks followed by an 8 week period when the dose of~     vardenafil may be reduced to 5mg or increased to 20mg. Subjects will then receive their~     'preferred' dose for 14 weeks. During this time Quality of Life Measures will be collected~     via questionnaires~   "
221335|NCT00661687|"~     The objective of this study is to evaluate the performance of the PureVision Lens designs~     when worn on a 30-day continuous wear basis~   "
221336|NCT00661674|"~     Opioid medications are commonly used for pain relief. When given over time, physical~     dependence can occur. This results in unpleasant side effects--such as agitation and~     nausea--if opioid medications are suddenly stopped. We are interested in knowing if a~     medication named Ondansetron can help ease or prevent symptoms associated with opioid~     withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved~     drug, palonosetron) can more effectively treat withdrawal symptoms with or without~     combination with an antihistamine called hydroxyzine (vistaril).~   "
221337|NCT00661661|"~     The purpose of this study is to determine the long-term effectiveness and safety of~     CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this~     study after they have completed participation in another qualifying study of CP-690,550.~   "
221338|NCT00661648|"~     This study evaluated that strict control of perioperative blood glucose following pancreatic~     resection by using an artificial pancreas would improve postoperative surgical site~     infection.~   "
221339|NCT00661635|"~     To evaluate the analgesic efficacy, general safety, and effects on health outcome measures~     and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients~     with moderate or severe pain following laparoscopic cholecystectomy surgery.~   "
221344|NCT00661570|"~     The purpose of this study is to investigate long-term clinical feasibility of a new voice~     prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation~     after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life,~     and reason for replacement.~   "
221346|NCT00661544|"~     1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic~          acid and high-dose Melphalan in patients with multiple myeloma~        2. To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and~          high-dose Melphalan in patients with multiple myeloma~        3. To determine the effects of arsenic trioxide on melphalan pharmacokinetics~   "
221347|NCT00661531|"~     This trial seeks to confirm the response rate for estrace treatment in a patients with~     hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine~     therapies.~   "
221348|NCT00661518|"~     Rationale: Aneurysm development, progression and rupture are characterised by extensive~     inflammation, dominated by the infiltration of T-cells, B-cells and macrophages. Recent~     studies into the pathophysiology of aneurysm wall degradation suggest a close relation~     between increased mechanical stress and the local activation of infiltrated lymphocytes and~     macrophages. The non-invasive detection of aneurysm wall inflammation, using~     18-fluorodeoxyglucose positron emission tomography (FDG-PET) might therefore provide valuable~     information on the extend of the disease and could clarify the role of mechanical stress on~     the propagation of aneurysm wall inflammation.~      Objective: Correlation of FDG uptake and in vitro aneurysm wall tensile strength. (primary~     objective). The effect of aneurysm sac depressurisation, after endovascular aneurysm repair,~     on aneurysm wall inflammation (secondary objective).~      Study design: Observational case series (pilot). Study population: Patients scheduled for~     conventional (open) and endovascular aneurysm repair.~      Main study parameters: Standard uptake value (SUV) measurements to asses FDG uptake in the~     aneurysm wall and in vitro aneurysm wall strength (N/mm).~      Nature and extent of the burden and risks associated with participation,~      benefit and group relatedness: Patients scheduled for conventional (open) or endovascular~     aneurysm repair are admitted to the hospital the day before surgery. At that point all~     patients will be evaluated using FDG-PET. Although intake of sugar-free liquids is permitted,~     glucose intake is restricted 6 hours prior to FDG-PET imaging. One hour after intravenous~     injection of 200-220 MBq FDG, whole body emission and transmission images will be acquired.~     To determine inflammation markers ( e.g. CRP), blood and urine samples will be collected~     prior to the operation and again 6 weeks after surgery. For in vitro aneurysm wall tensile~     strength testing wall specimens will be harvested during conventional aneurysm repair.~   "
221349|NCT00661505|"~     This single arm study will assess the efficacy, safety and tolerability of once-monthly~     administration of intravenous Mircera for the maintenance of hemoglobin levels in~     hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous~     injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time~     on study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
221350|NCT00661492|"~     To determine the time to progression produced by the combination of Novantrone (mitoxantrone)~     and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously~     treated with docetaxel-based chemotherapy. TTP is defined as time from the start of treatment~     date to the date the patient is first recorded as having disease progression, even in~     patients who discontinue study treatment early due to toxicity.~   "
221351|NCT00661479|"~     This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on~     visual function of a single injection of Brimonidine intravitreal implant in one eye of~     patients with Retinitis Pigmentosa.~   "
221352|NCT00661466|"~     The purpose of this study is to determine whether the CollaRx Bupivacaine Implant~     (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication~     needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.~   "
221353|NCT00661453|"~     This is a multi-center trial to test safety and evaluate early treatment intervention with~     valproic acid and carnitine in moderating SMA symptoms of Type I infants.~   "
221354|NCT00661440|"~     The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in~     the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition,~     a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be~     included; this subgroup will be analyzed in an exploratory manner only.~   "
221355|NCT00661427|"~     The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab~     will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not~     work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we~     will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We~     do not know if it will help. We can use what we learn from this research study to help other~     people with the same disease.~   "
221356|NCT00661414|"~     The purpose of this study is to determine the safety, tolerability and highest dose of ASONEP~     that can safely be administered to patients with cancer who are no longer being helped by~     standard treatments.~   "
221357|NCT00661401|"~     Objective: Measure serum IgG antibody to Streptococcus pneumoniae serotypes 1, 3, 5, 6B, 9V e~     14, Haemophilus influenzae type b and tetanus toxoid in patients with primary antibody~     deficiencies who were treated with subcutaneous immunoglobulin infusions.~   "
221358|NCT00661388|"~     This single arm study will assess the efficacy and safety of subcutaneous methoxy~     polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin~     levels in predialysis patients with renal anemia who are not currently treated with~     erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous~     injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated~     time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
221359|NCT00661375|"~     To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with~     unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine~     containing regimen.~   "
221360|NCT00661362|"~     Saxagliptin is a new investigational medication being developed for treatment of type 2~     diabetes. This study is designed to evaluate the efficacy and safety in adult patients who~     have inadequate glycaemic control when treated with metformin in addition to diet and~     exercise.~   "
221361|NCT00661349|"~     In retrospective studies, acceleration of hepatic fibrosis has been seen in Nevirapine (NVP)~     treatment when compared with Protease Inhibitors (PI) boosted with ritonavir treatment in~     patients with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) infection. The~     high incidence in our country of HIV-HCV co-infection, the availability of a new Kaletra~     (LPV/r) formulation (more convenient and better tolerated than soft capsules) as well as the~     possibility of analyzing hepatic fibrosis evolution in a fast and bloodless way, make~     attractive a study that, in a prospective way, could check the benefits of substituting NVP~     by LPV/r on hepatic fibrosis in this community.~   "
221568|NCT00658632|"~     The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB)~     Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive~     gastroesophageal reflux disease (eGERD).~   "
221362|NCT00661336|"~     RATIONALE: Buthionine sulfoximine may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of~     tumor cells. The tumor is said to be resistant to chemotherapy. Giving buthionine sulfoximine~     together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed.~      PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when~     given as an isolated limb infusion together with buthionine sulfoximine in treating patients~     with persistent or recurrent stage III malignant melanoma.~   "
221363|NCT00661323|"~     Magnetic resonance imaging (MRI) and echocardiography are two imaging methods that are used~     to obtain pictures of the heart and assess heart function. This study will evaluate a new,~     four-dimensional echocardiography approach of obtaining heart images to determine if it is as~     effective at evaluating heart function as MRI.~   "
221364|NCT00661310|"~     The purpose of this study is to measure the effects of an enhanced service where a~     pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and~     transferring information between primary and secondary care). Primary outcome measure is~     visits to hospital during a 12-month follow-up period, and the population is patients 80~     years and older.~   "
221365|NCT00661297|"~     Study to investigate the efficacy and safety of Vardenafil~   "
221366|NCT00661284|"~     A 52-week follow up study to investigate the duration of maintenance of efficacy in patients~     with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment~   "
221367|NCT00661271|"~     Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests~     benefits in mental health and quality of life outcomes. To evaluate further the specific~     effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program~     compared with a health education program.~   "
221368|NCT00661258|"~     This study focuses on collecting and analyzing quantitative data related to adherence to~     antiretroviral treatment from patients in Dali, China, over a one-year time-frame and~     generating preliminary data on an intervention designed to improve adherence to~     antiretroviral treatment among the study population.~   "
221369|NCT00661245|"~     The TOGA® trial is a prospective, multi-center, randomized sham-controlled trial designed to~     determine the safety and effectiveness of the TOGA System for the treatment of morbid~     obesity. The study will also determine the effect of the treatment on co-morbidities and~     quality of life.~      Subjects will be blinded to treatment or sham. Sham arm may crossover to TOGA treatment at 12~     months.~   "
221370|NCT00661232|"~     The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic~     Resonance Imaging can be used to predict improvement of the wall motion in regions of the~     heart with abnormal movement following bypass surgery or percutaneous angioplasty in various~     institutions across three continents.~   "
221371|NCT00661219|"~     The study will last three months. During the first month of treatment the subject will~     receive either 10 mg vardenafil or placebo. After 1 month of treatment the doctor, can choose~     to increase the dosage from 10 mg to 20 mg or decrease the dosage to 5 mg. The doctor will~     again evaluate, after 2 months of treatment if the subject wants to increase the dosage from~     10 mg to 20 mg or, if already done, to continue with the dosage of 20 mg or decrease to 10 mg~     or 5 mg. It will not be possible after this point to increase or decrease the dosage for the~     rest of the study. The subject will be asked to attend the clinic on four separate occasions~     over a period of 3 months. Every visit will last about 1 hour. At the first visit the doctor~     will ask the subject about their medical history, and the subject will be given a medical~     examination (including your heart rate, blood pressure and weight). The medical examination~     will also include an ECG. The subject will be asked to provide a blood and urine sample,~     which will be analysed and screened for drugs of potential abuse (e.g.cocaine, narcotics,~     sedatives, hypnotics). The subject will then be asked to fill in a questionnaire about their~     mood and feelings. The subject qualifies, they will have an interview with a trained mental~     health care provider who will assess their level of depression. At the end of the visit, the~     doctor will provide the subject with a diary in which they must record details about their~     attempts at sexual activity during the next 4 weeks. The subject will be asked to make at~     least 4 attempts at sexual intercourse on 4 separate days and to record the attempts in the~     diaries. After 4 weeks the subject will return to the clinic. They will be asked to fill in~     different questionnaires about their sexuality, mood and feelings, general quality of life,~     self-esteem and sexual activity in the last 4 weeks. Two additional blood and urine samples~     will be collected. An interview with the trained mental health care provider who will~     re-assess their level of depression. At this visit all information collected so far will be~     assessed and the doctor will check to see if the requirements to enter the treatment period~     are fulfilled. The subject may be excluded from further participation in the study, for~     example due to results of the blood analysis or if your level of depression did not meet the~     criteria for the study. If the subject is able to participate to the study they will be given~     the study drug. At each visit, adverse events will be discussed and whether there is any~     change in medicine. Vital signs and ECG will be obtained at visit one, two, five and/or~     Premature Termination. At every visit the subject will receive a diary in which they must~     record details about their attempts at sexual activity during the period between each visit~     and the number of tablets taken. Subjects will also be asked to fill in different~     questionnaires about their sexuality, mood and feelings, self-esteem and sexual activity.~     Subjects will also be contacted by telephone, at 2, 6 and 10 weeks after starting the study~     medication, 24 hours after the last dose of study medication. The doctor will give the study~     drug on 3 occasions. Should the subject or doctor prematurely stop trial participation the~     subject will be required to return to the clinic for a physical examination, vital signs and~     have blood samples and ECG obtained. They will also be asked to fill in different~     questionnaires.~   "
221372|NCT00661206|"~     The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy~     after DES implantation is not inferior to that of a 12 month therapy.~   "
221373|NCT00661193|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may~     kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone~     or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV~     non-small cell lung cancer.~   "
221374|NCT00661180|"~     The purpose of this study is to evaluate the anti-cancer activity and safety of Bay 43-006,~     in patients who have Chronic Myelogenous Leukemia that resisted to Gleevec treatment, one of~     the standard medication administered for these patients.~   "
221375|NCT00661167|"~     The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for~     recurrence or unresectable gastric cancer patients who have received one prior regimen~     containing fluoropyrimidine and developed disease progression or recurrence.~   "
221376|NCT00661154|"~     To determine whether using a radiolabelled analog of 5-FU, [18F]-5-fluorouracil, for PET/CT~     imaging can visually demonstrate differential chemotherapy delivery to known tumor sites~     before and after administration of bevacizumab and determine the optimal timing of~     bevacizumab administration to maximize the chemotherapy delivery into the tumor for improved~     cancer treatment.~   "
221432|NCT00660413|"~     The purpose of this study was to compare two methods for neuromuscular monitoring,~     acceleromyography and mechanomyography for establishing the dose-response relationship and~     the potency of a neuromuscular blocking agent using rocuronium as an example. We hypothesized~     that there would be no significant difference between potencies estimated using~     acceleromyography and mechanomyography.~   "
221377|NCT00661141|"~     This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with~     alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited~     metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath~     and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol.~     Long-term, serious health risks have been associated with repeated exposure to acetaldehyde,~     a carcinogen, among ALDH2-deficient individuals.~   "
221378|NCT00661128|"~     Sudden cardiac arrest (SCA) is a sudden, unexpected loss of heart function. It is a leading~     cause of death, and more than 400,000 people in the United States die each year as a result~     of SCA. This study will analyze genetic samples of people who have experienced SCA and people~     who have not experienced SCA to determine if there is a genetic basis for SCA.~   "
221379|NCT00661115|"~     To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.~   "
221380|NCT00661102|"~     This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or~     placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast~     cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who~     have been receiving oral Xeloda for at least 5 days will be randomized to receive~     prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The~     anticipated time on study treatment is until disease progression or development of hand-foot~     syndrome, and the target sample size is 500+ individuals.~   "
221381|NCT00661089|"~     The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles~     around the shoulder is effective in treating shoulder pain and improving function in patients~     with shoulder pain and involuntary muscle tightness after a stroke.~   "
221382|NCT00661076|"~     This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS +~     adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B~     patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg~     po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a~     further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po~     daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180~     micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free~     follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size~     is <100 individuals.~   "
221383|NCT00661063|"~     Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo~     in patients with diabetic neuropathic pain~   "
221384|NCT00661050|"~     Complementary and alternative medicine (CAM) is the term for medical products and/or~     practices that are not part of the current standard of care. Standard care is what medical~     doctors, doctors of osteopathy and allied health professionals, such as registered nurses and~     physical therapists, practice. Alternative medicine means treatments that you use instead of~     standard ones. Complementary medicine means nonstandard treatments that you use along with~     standard ones. The purpose of this study is to determine whether there is any improvement in~     symptoms reported by patients with chronic painful bladder syndrome when participating in~     alternative medical therapy/ exercise and meditative techniques. The specific alternative~     techniques participants will be randomized to in this trial include: Tai Chi instruction or~     walking exercise combined with sitting meditation.~   "
221385|NCT00661037|"~     The aim of this prospective observational study is to evaluate the safety, over a follow-up~     of 2 years, of two strategies, consisting in performing or not performing defibrillation~     testing(DT) during first implant of implantable cardioverter defibrillator~   "
221386|NCT00661024|"~     Some recent studies have shown that intraoperative neuromonitoring (IONM) can aid the~     recurrent laryngeal nerve (RLN) identification during thyroid surgery. However, the role of~     IONM in reducing the incidence of RLN injury rate and the value of this method in predicting~     postoperative RLN function remain controversial. Only a few published series represent level~     III of evidence and grade C of recommendation according to the evidence-based criteria~     (Sackett's classification, modified by Heinrich). Thus, the aim of this randomized clinical~     trial was to compare the impact of RLN visualization versus IONM on their morbidity following~     thyroid surgery.~   "
221387|NCT00661011|"~     The purpose of this study is to determine if radical radiochemotherapy on the mediastinum~     after lobectomy can be associated with significant long term survival in patients with~     initially unresectable stage III NSCLC responding to induction chemotherapy but in which the~     residual disease is too large to be treated by radiotherapy.~   "
221388|NCT00660998|"~     Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction~   "
221389|NCT00660985|"~     Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene.~   "
221390|NCT00660972|"~     The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has~     been shown in several trials to be highly effective. The purpose of this trial is to estimate~     the viral load decay rate in treatment-naive HIV infected participants receiving RAL and~     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).~   "
221391|NCT00660959|"~     The present study is designed to confirm and extend the observation from previous studies~     that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with~     SIADH.~   "
221392|NCT00660946|"~     To determine whether point of care (POC) International Normalized Ratio (INR) test results~     correlate with plasma INR measures in hemodialysis patients.~   "
221393|NCT00660933|"~     The aim of the study is to compare the effect of intravenous versus oral iron in women with~     severe postpartum anemia.~   "
221394|NCT00660920|"~     The purpose of this study is to determine the maximum tolerated dose or a recommended dose of~     oral AP24534 in a defined schedule in patients with refractory or advanced chronic~     myelogenous leukemia and other refractory hematologic malignancies.~   "
221395|NCT00660907|"~     This study is being carried out to see if dapagliflozin as an addition to metformin is~     effective and safe in treating patients with type 2 diabetes when compared to glipizide~     (sulphonylurea) as an addition to metformin treatment.~   "
221500|NCT00659529|"~     The purpose of this study is to determine whether sildenafil can decrease inflammation in CF~     lung disease.~   "
255544|NCT00205920|"~     The purpose of this study is to determine the effective dose of the Aeris BLVR System in~     patients with advanced emphysema.~   "
221396|NCT00660894|"~     RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. It is not yet known whether giving tegafur-uracil together with~     leucovorin is more effective than giving S-1 in treating patients with stage III colon~     cancer.~      PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with~     leucovorin to see how well it works compared with giving S-1 in treating patients with stage~     III colon cancer that has been completely removed by surgery.~   "
221397|NCT00660881|"~     The primary objective of the study is to assess the safety of epratuzumab in patients with~     SLE.~   "
221398|NCT00660868|"~     Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like~     phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis~     is that pentoxifylline could lead to increased sensitivity to odors.~   "
221399|NCT00660855|"~     The objectives of this study were to assess the analgesic efficacy and safety of~     parecoxib/valdecoxib on post-laparoscopic surgery analgesia.~   "
221400|NCT00660842|"~     The purpose of this study is to study efficacy and the effects on quality of life in women~     with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and~     paclitaxel compared to those treated with standard every 3 weeks schedule of the same~     chemotherapy.~   "
221401|NCT00660829|"~     The Purpose of this study is to determine if one allergy medication (0.15% azelastine~     hydrochloride) is more effective than Placebo alone.~   "
221402|NCT00660816|"~     RATIONALE: Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known whether giving pemetrexed~     disodium or docetaxel together with erlotinib hydrochloride is more effective than giving~     pemetrexed disodium or docetaxel alone in treating non-small lung cancer.~      PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium or~     docetaxel together with or without erlotinib hydrochloride works in treating patients with~     stage IIIB or stage IV non-small cell lung cancer.~   "
221403|NCT00660803|"~     Characterize the demographic and clinical features, as well as the main treatment results,~     among patients with advanced breast cancer treated with fulvestrant in Brazil.~   "
221404|NCT00660790|"~     The aim of the study is to develop a model that allows early identification of type-2~     diabetic patients who will face progressive atherosclerosis despite intensive,~     multifactorial, target oriented treatment~   "
221405|NCT00660777|"~     Background: Upper airway muscle weakness plays an important role in the genesis of~     obstructive sleep apnea (OSA). Oropharyngeal exercises are derived from speech therapy~     consisting of isometric and isotonic exercises directed to tongue, soft palate and lateral~     pharyngeal wall. We hypothesized that oropharyngeal exercises will attenuate OSA severity.~      We will include 30 moderate OSA patients (apnea-hypopnea index (AHI), between 15 and 30~     events/hour) that will randomize to 3 months of general measurements and daily nasal lavage~     (n=15, control) or daily oropharyngeal exercises (~30 min) plus nasal lavage (n=16). Full~     polysomnography, anthropometric measurements, questionnaires derived from Berlin, Epworth and~     Pittsburgh evaluating quantitatively (range) snoring frequency (0-4) and intensity (1-3),~     daytime sleepiness (0-24) and sleep quality (0-21), respectively will be performed at~     baseline and study end.~   "
221406|NCT00660764|"~     In an observational multi-centre study (HEROS), the effects of starting treatment with~     rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement,~     in patients with a dissimilar high-risk profile who had not been treated with cholesterol~     lowering drugs at least in the past three months. Also set-up costs of rosuvastatin treatment~     and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were~     studied.~   "
221407|NCT00660751|"~     The role of central serotonergic and adrenergic systems in the effectiveness of DNIC (Diffuse~     Noxious Inhibitory Control) will be tested before and after taking Duloxetine and Placebo in~     a double blind study.~   "
221408|NCT00660738|"~     Objectives: to evaluate and compare the responses to the various functional tests, and the~     concordance between the six-minute walk test in hallway (6MWT) and the of oval track~     (6MWToT), of treadmill (6MWTT), and of treadmill with inclination (6MWTTI), the six-minute~     step test (6MST) and the sit-to-stand test (STST), in patients with Chronic Obstructive~     Pulmonary Disease (COPD), and to correlate the responses with functional state and quality of~     life. Methods: Ten patients with COPD (71±8years, FEV1<80%predicted) were assessed using the~     functional tests. A dyspnea was assessed using the London Chest Activity of Daily Living and~     the Medical Research Council scales; and the quality of life was assessed using the St~     George's Respiratory Questionnaire (SGRQ).~   "
221409|NCT00660725|"~     This is a research study that will try to find the highest and safest dose of an experimental~     drug, vandetanib, that can be given in combination with two standard chemotherapy agents,~     gemcitabine and oxaliplatin, to subjects with advanced solid malignancies.~   "
221410|NCT00660712|"~     A registry study to identify the patient-diagnosis-treatment characteristic profile of~     patients with bipolar disorder in Turkey.~   "
221411|NCT00660699|"~     To assess the feasibility of administering induction chemotherapy with gemcitabine and~     docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation~     gemcitabine/docetaxel chemotherapy.~   "
221412|NCT00660686|"~     The purpose of this study is to conduct a 12-month randomized controlled trial comparing the~     effects of strength and impact exercise training to flexibility/relaxation training on body~     composition (bone, muscle and fat mass), physical function (strength, gait, power, balance~     and self-report physical function and symptoms) in men currently treated with hormone therapy~     for prostate cancer.~   "
221413|NCT00660673|"~     The primary objective is to provide continued access to subjects who would like to continue~     levodopa-carbidopa intestinal gel (LCIG), after completion of an open-label study (S187.3.003~     or S187.3.004).~   "
221414|NCT00660660|"~     The purpose of this research study is to compare the safety and effectiveness (how well the~     medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any~     medication) taken daily in relieving nighttime heartburn and problems sleeping in patients~     with gastroesophageal reflux disease (GERD).~   "
221415|NCT00660647|"~     Optimized treatment algorithm in early rheumatoid arthritis:~      Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the~     treatment of early rheumatoid arthritis.~      A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the~     additive effect of adalimumab concerning inflammatory control and inhibition of erosive~     development.~      Optimized Treatment Algorithms for Patients with Early RA~   "
221416|NCT00660634|"~     To investigate whether endovascular revascualrization of infrainguinal arterial obstructive~     disease has an effect on brachial artery reactivity~   "
221417|NCT00660621|"~     To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer~     implantation, followed by concomitant limited field radiation therapy and temozolomide,~     followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery~     for newly-diagnosed high grade glioma.~   "
221418|NCT00660608|"~     Fifty patients will be enrolled into the study. The purpose of the study is to investigate~     the relevance of Hct levels in determining need for transfusion during operations employing~     bypass as well as to test the hypothesis that, while HCt levels may decrease during surgery ,~     red blood cell mass and tissue oxygenation remain fairly constant.~   "
221419|NCT00660595|"~     This pilot trial in Finland is designed to evaluate in a randomized fashion change of~     agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or~     Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first~     visits on days 1, 2, 4 or 5 and 7 ± 1.~   "
221420|NCT00660582|"~     The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin~     (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor~     (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII~     study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or~     C). Effect-data has not yet been published but the combination is well tolerated, and other~     studies have shown that Erbitux administered with chemotherapy seem to be more efficient than~     chemotherapy alone.~      The main purpose with this study is to investigate the effect of FLOX and Erbitux given every~     second week as first line treatment for patients with metastatic colorectal cancer and K-RAS~     wildtype tumor.~      The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that~     patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations.~   "
221421|NCT00660569|"~     The purpose of this study is to identify the potential issues during short and mid term~     utilization of Pulmicort hydro fluoroaklane (HFA) pressurized metered-dose inhaler (pMDI)and~     describe associated factors.~   "
221422|NCT00660543|"~     This pilot clinical trial studies how a magnetic resonance imaging (MRI) study with~     ferumoxytol works as a contrasting agent in assessing early response in patients with~     glioblastoma multiforme receiving temozolomide and radiation therapy. Ferumoxytol is a very~     small form of iron particles that are injected into the body and taken up by certain tissues~     which may make these tissues easier to see during imaging. Diagnostic procedures, such as an~     MRI study with ferumoxytol, may help measure a patient's response to earlier treatment.~   "
221423|NCT00660530|"~     Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the~     loss of excretory function of the kidney. This in turn may lead to the development of~     secondary hyperparathyroidism (SHPT) and renal osteodystrophy. Lanthanum carbonate, a~     phosphate binding agent, works by releasing lanthanum ions in the gastrointestinal tract to~     bind dietary phosphate and is effective in the management of hyperphosphatemia and in~     preventing secondary hyperparathyroidism.~      Patients taking lanthanum carbonate as part of their phosphate binder therapy are counseled~     to chew the tablets completely before swallowing, with or immediately after meals. However,~     ESRD patients who are intubated or are receiving enteral tube feedings are unable to chew the~     lanthanum carbonate tablets. For such patients, medications are commonly crushed and~     administered through a gastrostomy tube (G-tube). Some patients may also prefer to crush the~     lanthanum carbonate tablets and mix it with food instead of chewing. To date, it is not known~     if crushing the lanthanum carbonate tablets prior to administration and taking it with food~     will be as efficacious as chewing it.~      The objective of this study is to compare the efficacy of phosphate binding between chewed~     and crushed lanthanum carbonate in patients undergoing hemodialysis.~   "
221424|NCT00660517|"~     The purpose of this study is to determine if two allergy medications (azelastine and~     fluticasone) are more effective than placebo or either medication alone (azelastine or~     fluticasone)~   "
221425|NCT00660504|"~     This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from~     growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with~     cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease~     small cell lung cancer The subject, who is randomized to AP group may be involved into a~     pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.~   "
221426|NCT00660491|"~     Postprandial lipemia and exercise oppose each other in terms of cardiovascular risk, however~     the mechanism of their interaction is not well understood.~      Therefore we want to study vascular function, as assessed by brachial artery (BA) flow~     mediated dilation (FMD), in healthy men before and after a high fat meal (HFM) preceded~     (16-18 hrs) by rest, a single bout of continuous moderate intensity exercise (CME), and high~     intensity interval exercise (HIIE).~   "
221427|NCT00660478|"~     Randomized clinical comparison of the serolimus eluting Cypher stent and the zotarolimus~     eluting Endeavor stent.~   "
221428|NCT00660465|"~     The purpose of this study is to explore how arterial PaCO2 effect regional Blood Oxygen Level~     Dependent (BOLD) signal, and indirectly the brain regional O2 level .~   "
221429|NCT00660452|"~     A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL~     dust mites solution compared with placebo for reduction of asthma symptoms.~   "
221430|NCT00660439|"~     This study compares Narrative Exposure Therapy with a Waiting list control group, both~     consists of traumatized patients with diagnosed Posttraumatic Stress Disorder. The main aim~     is to investigate if the patients psychiatric symptoms and levels of the stress hormone~     cortisol will improve more after Narrative Exposure Therapy than the Waiting list (i.e. no~     intervention).~   "
221431|NCT00660426|"~     Dose escalation of oxaliplatin, gemcitabine and capecitabine in the treatment of patients~     with advanced gastrointestinal malignancies and other solid tumors.~   "
221433|NCT00660400|"~     The purpose of this study is to find out if treating people who have high-risk~     myelodysplastic syndrome (MDS) with 5-Azacitidine (Vidaza) prior to their allogeneic~     hematopoietic cell transplant (HCT) is helpful in preventing their myelodysplastic syndrome~     from coming back.~      In previous research, 5-Azacitidine appeared to help the bone marrow of a patient with MDS~     begin to function more normally. This means bone marrow cells can grow and do their work the~     way they were meant to. 5-Azacitidine is approved by the Food and Drug Administration (FDA)~     for the treatment of MDS. The effect of 5-Azacitidine in patients receiving hematopoietic~     cell transplants have not been studied.~   "
221434|NCT00660387|"~     The primary objective of this study was to demonstrate the superiority of levodopa -~     carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12~     weeks.~   "
221435|NCT00660374|"~     This trial is conducted in South America. This trial aims for a comparison of the safety and~     efficacy of insulin NPH and a new insulin formulation on blood glucose control.~   "
221436|NCT00660361|"~     Human immunodeficiency virus/Hepatitis B virus (HIV/HBV) co-infections are frequently~     observed due to shared routes of transmission, with reported figures indicating 6-9% of~     HIV-infected individuals in developed countries are chronically infected with HBV. HIV~     infection impacts on the natural progression of HBV infection, increasing levels of HBV~     replication and the risk of liver-associated mortality. Liver diseases associated with HBV~     are affected by the antiviral drugs used for HIV infection (toxic side effects), the current~     immune function in the patient, by improvements in the immune system brought about by control~     of the HIV infection, and by the development of resistance to the antiviral agents used for~     both the hepatitis B and the HIV infection. Tenofovir (TDF) is a newer antiviral drug that is~     frequently used for HIV infection and is also highly active against hepatitis B; however it~     is still unknown whether resistance to TDF will eventually develop and how this will affect~     the long-term outcomes~   "
221437|NCT00660348|"~     RATIONALE: Giving medications in different ways may change their effectiveness in controlling~     pain. It is not yet known whether intrathecal therapy is more effective than standard therapy~     in controlling pain in patients with pancreatic cancer.~      PURPOSE: This randomized clinical trial is studying standard pain control to see how well it~     works compared with intrathecal therapy in controlling pain in patients with locally~     advanced, unresectable, or metastatic pancreatic cancer.~   "
221438|NCT00660335|"~     The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic~     human secretin) with MRCP in subjects with abnormalities of the pancreas.~   "
221439|NCT00660322|"~     Asthma is the most common chronic disease of childhood and a major cause of morbidity in the~     United States. If asthma symptoms are controlled, a child with asthma can stay well and lead~     a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and~     emergent health care utilization in children with persistent asthma, and is safe for~     long-term use. However, inhaled steroids are underused in community asthma care.~      The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach~     to help the parent manage the child's asthma care. The coach will teach self-management~     skills, help the parent to use the child's asthma medicines effectively, provide support and~     remind the parent to go for follow-up care with the pediatrician. We hypothesized that the~     Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that~     require emergent care, improve the quality of life of children with asthma and their parents,~     and increase the daily use of inhaled steroids in children with persistent asthma. We~     evaluated the Telephone Asthma Program in a randomized controlled trial involving 362~     children aged 5 to 12 years old cared for by community pediatricians. Eligible children were~     randomized to the TAP program or usual care by their pediatrician.~   "
221440|NCT00660309|"~     The study objective was to assess the effect of single and multiple doses of aliskiren on~     renal plasma flow, glomerular filtration rate and to compare the effects of single and~     multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular~     filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.~   "
221441|NCT00660296|"~     CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce~     pain after and during colonoscopy. There is limited data, that Co2 is similar effective in~     sedated patients. Furthermore it had not been investigated if patient's compliance for~     participating in cancer screening could be improved by using Co2.~      The aim of the study is to assess postoperative pain and satisfaction after colonoscopy by~     comparing C02 with air.~   "
221442|NCT00660283|"~     To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer~     implantation, followed by concomitant limited field radiation therapy and temozolomide,~     followed by dose dense temozolomide in subjects undergoing initial surgery for~     newly-diagnosed high grade glioma.~   "
221443|NCT00660270|"~     To describe the overall survival and disease-free survival in pancreatic cancer patients~     treated with adjuvant chemoradiation with cisplatin, continuous infusion 5FU and interferon~     alpha followed by gemcitabine.~      To describe the toxicities associated with adjuvant chemoradiation with cisplatin. 5FU and~     interferon alfa followed by gemcitabine in patients with pancreatic cancers.~   "
221444|NCT00660257|"~     A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate~     the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1)~     vaccine (whole-virion, aluminium-adjuvanted).~   "
221445|NCT00660244|"~     The purpose of this study is to investigate efficacy and tolerability under anastrozole~     (Arimidex) treatment.~   "
221446|NCT00660231|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and bexarotene, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying giving gemcitabine together with bexarotene to see~     how well it works in treating patients with progressive or refractory stage IB, stage II,~     stage III, or stage IV cutaneous T-cell non-Hodgkin lymphoma.~   "
221513|NCT00659360|"~     This phase II trial is studying how well AZD0530 works in treating patients with recurrent~     locally advanced, or metastatic soft tissue sarcoma. AZD0530 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
221514|NCT00659347|"~     The primary objectives of this placebo-controlled trial are to evaluate effectiveness and~     safety of DOV 21,947 at two oral dose levels.~   "
221447|NCT00660218|"~     This study involves two phases. Phase I of this study is designed to find out the maximum~     dose of paclitaxel poliglumex which can be safely given to subjects when combined with~     cetuximab and radiotherapy in head and neck cancer. Once the maximum safe dose of paclitaxel~     poliglumex is found, Phase II of the study will continue to find out whether the addition of~     paclitaxel poliglumex increases tumor response and survival compared to treatment with~     cetuximab and radiotherapy alone.~      An additional 20 patients have been added, to balance data. These patients must be HPV~     negative.~   "
221448|NCT00660205|"~     Cancer is a well known risk factor for venous thromboembolism (VTE) such as deep venous~     thrombosis (DVT) and pulmonary embolism (PE). Today we know that patients with~     adenocarcinomas of the gastro intestinal tract (GI-tract) often is in a hypercoagulable~     state.~      In our observational study we collect patients admitted to department with a tentative~     diagnosis of upper GI cancer including pancreas cancer and offer them flow doppler~     ultrasounds of both legs for diagnosis of DVT in the entire treatment time. The routine~     CT-scan of the chest is modified to diagnose PE. This will be compared with blood samples~     analysed for coagulation markers including D-dimer - a fibrinogen degradation product.~   "
221449|NCT00660192|"~     The hypothesis of this study is that injection of botulinum toxin A into the muscles around~     the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and~     frequency of migraine headaches by 50%.~   "
221450|NCT00660179|"~     The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two~     different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with~     symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992)~     prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk~     profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.~   "
221451|NCT00660166|"~     The purpose of this research study is to examine the safety of infusing escalated doses of~     allogeneic (from a relative of the patient), enriched natural killer (NK) cells after~     autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion~     of these NK cells early after an autologous stem cell transplant will help to eliminate and~     eradicate any residual cancerous cells that remain in the body and may have survived the~     chemotherapy or radiation.~   "
221452|NCT00660153|"~     The FOLFOX6 regimen is a standard chemotherapy regimen for the treatment of patients with~     colorectal cancer and other gastrointestinal cancers. Tivozanib (AV-951) is a targeted~     anti-angiogenesis agent that has demonstrated acceptable tolerability in a phase I clinical~     trial. This study is designed to test the hypothesis that tivozanib (AV-951) can be combined~     with standard FOLFOX6 chemotherapy for the treatment of patients with colorectal and other~     gastrointestinal cancers. The purpose of this study is to determine the maximum dose of~     tivozanib (AV-951) that can be safely combined with FOLFOX6 chemotherapy, and to evaluate the~     safety profile, tolerability, and pharmacokinetics of this combination.~   "
221453|NCT00660140|"~     To determine the activity of gemcitabine combined with carboplatin in the treatment of~     patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.~   "
221454|NCT00660127|"~     The purpose of this research study is to assess whether seeing other people itch affects itch~     perception in patients with atopic dermatitis and healthy subjects.~   "
221455|NCT00660114|"~     This open label, non-interventional study is to show the efficacy of Pulmicort®Respules® in~     cough variant asthma in patient aged 5-year old or younger in outpatient department~   "
221456|NCT00660101|"~     To determine if a vaccine made from the patient's own tumor tissue can stimulate an immune~     response against the patient's tumor cells. To determine the safety of the vaccine.~   "
221457|NCT00660088|"~     AC-1202 (Ketasyn) is a nutritional beverage currently being studied in neurodegenerative~     conditions including Alzheimer's disease. The current study is a randomized, open-label trial~     to compare the safety, tolerability, and PK profiles of 3 formulations of Ketasyn~     administered on a daily basis for 14 days, with and without a 7-day titration period, in~     normal, healthy elderly volunteers.~   "
221458|NCT00660075|"~     Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has~     been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes~     mainly through incretin hormone-mediated improvements in islet function. Although clinical~     studies to date indicate that fasting lipid levels are minimally affected by DPP-4 inhibitor~     treatment, animal studies suggested that DPP-4 inhibition reduce intestinal triglyceride (TG)~     absorption and apolipoprotein production and increased chylomicron catabolism. Therefore, the~     present study was designed to examine the effects of sitagliptin on postprandial lipemia in~     patients with type 2 diabetes. A possible reduction in postprandial atherogenic~     triglyceride-rich lipoproteins (TRL) levels by sitagliptin would add to therapeutic utility~     of this DPP-4 inhibitor and suggest the potential to reduce cardiovascular risk in patients~     with type 2 diabetes.~   "
221459|NCT00660062|"~     The main purpose of this study is to investigate the relapse preventing efficacy of~     escitalopram in a dose range and nortriptylin in a single dose in patients having been~     treated successfully with a course of electroconvulsive treatment (ECT).~   "
221460|NCT00660049|"~     The purpose of this study is to evaluate the feasibility and usability of a new portable and~     compact wound dressing device for the treatment of small chronic skin wounds.~   "
221461|NCT00660036|"~     The purpose of this study is to investigate the combination of gemtuzumab ozogamicin,~     mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.~   "
221462|NCT00660023|"~     This single-arm study will assess the efficacy and safety of monthly administration of~     intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of~     hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine~     clinical practice in Hungary. Participants currently receiving maintenance treatment with~     intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the~     starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been~     receiving.~   "
221463|NCT00660010|"~     The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and~     effective in treating children with Central Precocious Puberty (CPP), and to assess long term~     effects of leuprolide acetate treatment after therapy is discontinued.~   "
255545|NCT00205907|"~     The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in~     patients with advanced emphysema.~   "
221464|NCT00659997|"~     Field epidemiological studies undertaken during 2005 in four village locations in Northern~     Unguja, Zanzibar examined mothers and their pre-school aged children for helminth infections.~      The prevalence of Ascaris lumbricoides was found to have remained relatively high despite~     community-wide treatment with the mass administration of Albendazole (a WHO recommended~     de-wormer) in coordination with community vitamin A supplementation.~      One hypothesis for this is that the children and mothers had Ascaris infections more tolerant~     to Albendazole that subsequently failed to clear. It is necessary to compare the present drug~     efficiency of Albendazole (first-line de-wormer) with Levamisole (second-line de-wormer) on~     STH infections such patients a case-control setting to shed light on the putative resistance~     of local Ascaris/Trichuris to albendazole.~      In so doing, this should clarify whether there is resistance developing towards Albendazole~     and have possible implications for introducing combination therapies of Levamisole and~     Albendazole for first line de-worming mothers and their children in the future.~   "
221465|NCT00659984|"~     RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry~     radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem~     cell transplant using stem cells from the patient may be able to replace blood-forming cells~     that were destroyed by I 131 MIBG.~      PURPOSE: This phase II trial is studying the side effects and best dose of iodine I 131 MIBG~     followed by a stem cell transplant in treating young patients with relapsed or refractory~     high-risk neuroblastoma.~   "
221466|NCT00659971|"~     The purpose of this study is to determine the optimal dose of PAC113 mouthrinse for treatment~     of oral candidiasis in HIV seropositive patients.~   "
221467|NCT00659958|"~     The purpose of this study is to acquire additional information about the appropriate level of~     dosing of Zonisamide when it is prescribed for patients with partial onset epileptic crisis~     who are already being treated with two other antiepileptic drugs.~   "
221468|NCT00659945|"~     Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for~     prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48~     hours after surgery.~      Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in~     patients who have received aprepitant plus ondansetron versus ondansetron plus placebo for up~     to 48 hours after surgery.~   "
221469|NCT00659932|"~     This study was designed to assess whether a cognitive behavior therapy (CBT) program for~     diabetes clinic patients was acceptable, improved quality of life and produced measurable~     change in levels of depression, anxiety and stress.~   "
221470|NCT00659919|"~     Administration of trazodone for the treatment of neuroleptic induced acute akathisia in a~     cross-over fashion of 6 days duration. 3 days of placebo and 3 days of trazodone.~   "
221471|NCT00659906|"~     The purpose of this study is to conduct a 12-month randomized controlled trial comparing the~     effects of strength training exercise to stretching and relaxation exercise (control) on body~     composition (bone, muscle and fat mass), energy balance, bone turnover, and physical function~     (strength, power, gait, balance and self-report physical function and symptoms) in women who~     experienced premature menopause from chemotherapy for breast cancer.~   "
221472|NCT00659893|"~     Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25~     cm2 treatment areas, as compared to individual 25 cm2 treatment areas.~   "
221473|NCT00659880|"~     This study will follow patients after routine surgery of a meniscal allograft transplant.~   "
221474|NCT00659867|"~     This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study~     in subjects with long standing ulcerative colitis in clinical remission with indication for~     surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and~     EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted~     biopsies or by standard endoscopy with random and targeted biopsies. The aim is to~     investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard~     endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the~     proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy~     versus standard endoscopy.~   "
221475|NCT00659854|"~     Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will~     assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant.~     Specifically , infants will be investigated by sleep studies in order to test this~     hypothesis.~   "
221476|NCT00659841|"~     The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as~     a nasal spray once daily in patients with SAR. The secondary objectives are to evaluate~     Quality-of-Life and safety.~   "
221477|NCT00659828|"~     We will assess the endocrine and immune effects of leptin replacement in leptin-deficient~     children, from a consanguineous Turkish family. We hypothesize that leptin replacement will~     have significant effects on immune and endocrine function.~   "
221478|NCT00659815|"~     The objective of the study is to evaluate the product performance of Bausch & Lomb ReNu~     MultiPlus Multi-Purpose Solution in a new packaging configuration~   "
221479|NCT00659802|"~     The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with~     active mild to moderate ulcerative colitis (UC), compared with placebo.~   "
221480|NCT00659789|"~     Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure~     the infection, making it a life-long treatment that requires sustained patient compliance and~     imposes significant individual and societal financial burdens on healthcare services.~     Furthermore, ART side effects often require medication that increases the inconveniences and~     financial burdens of HIV management. Of further concern is the emergence of viruses resistant~     to ART that can result in treatment failure.~      ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV~     immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this~     study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.~   "
221536|NCT00659048|"~     The primary objective of this study is to demonstrate that there are no clinically relevant~     additive inhibitory effects on the HPA-axis when ciclesonide nasal spray is concomitantly~     administered with orally inhaled HFA-BDP. The secondary objectives are to evaluate safety and~     tolerability of the combined dosing regimen of orally inhaled HFA-BDP and ciclesonide nasal~     spray.~   "
221481|NCT00659776|"~     The purpose of this study is to address safety and efficiency of a new iron particle contrast~     agent, ferumoxytol. This product may be more useful in viewing the vessels of the brain and~     areas in the brain on magnetic resonance imaging (MRI), or magnetic resonance angiography~     (MRA), than the standard substance, gadolinium, injected during MRI and MRA.~      Other ways in which ferumoxytol may help include the following:~        1. Ferumoxytol may provide the ability to better see inflammatory lesions on magnetic~          resonance imaging (MRI) scans~        2. Ferumoxytol may be useful in its ability to cross blood vessels into inflammatory~          processes, and~        3. Ferumoxytol, because of its size and ability to get into the area next to your~          inflammatory lesion and could assist in the treatment of inflammatory lesions~          association with cardiac surgery or CNS vascular surgery.~   "
221482|NCT00659763|"~     The purpose of this study is to determine whether a clinical diagnosis of irritable bowel~     syndrome based on patient reported symptoms and a few blood tests is safe, and to determine~     whether a clinical diagnosis is as good for the patient and as economical for the society as~     a diagnosis based on exclusion of a number of organic diseases by performing a number of~     blood tests, fecal analyzes and a scopic examination of bowel.~      The purpose of the second part of the study is to determine which intestinal parasites the~     patients have in their bowel and whether these parasites are the cause of the disease.~   "
221483|NCT00659750|"~     The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as~     a nasal spray once daily in patients with PAR. The secondary objectives are to evaluate~     Quality-of-Life and safety.~   "
221484|NCT00659737|"~     Recent evidence suggests multiple drug therapy is superior to single agents. The study~     compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time,~     and unplanned hospital admission in patients with high risk for PONV treated with oral~     aprepitant with or without transdermal scopolamine preoperatively.~   "
221485|NCT00659724|"~     The purpose of this study is to collect information on the ease of use and thrombogenicity of~     the Polyflux HD-C4 Big and Fresenius Optiflux 180NR or 200NR dialyzers under conditions of~     routine clinical use for hemodialysis.~   "
221486|NCT00659711|"~     Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination~     with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin~     has been shown to have fewer side effects in the control of blood glucose values.~      Obesity and diabetes are states of increased inflammation and can influence the free radicals~     and inflammatory markers (chemicals in the blood which increase due to inflammation in the~     body) and are also major risk factors for atherosclerotic disease. In this study we want to~     see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an~     anti-inflammatory effect in the human. The purpose of this study is to determine if the~     addition of sitagliptin to diabetic patients will provide added benefit. We believe that~     sitagliptin provides these added benefits by suppressing free radicals (charged substances~     that cause damage to the body) and inflammation.~   "
221487|NCT00659698|"~     This study evaluated that strict control of perioperative blood glucose following hepatic~     resection by using an artificial pancreas would improve postoperative surgical site~     infection.~   "
221488|NCT00659685|"~     Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 mg~     ODT~   "
221489|NCT00659672|"~     The purpose of this study is to determine if consumption of whey protein, compared with soy~     protein or a carbohydrate food decreases blood pressure along with reducing risk factors for~     heart disease.~   "
221490|NCT00659659|"~     Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of~     MEDI-563 on eosinophil counts in airway mucosal biopsies~   "
221491|NCT00659646|"~     The purpose of this study is to determine whether the gentamicin-collagen sponge when~     combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and~     effective in treating moderately infected skin ulcers compared to treatment only with~     standard daily wound care and an oral antibiotic (levofloxacin).~   "
221492|NCT00659633|"~     The purpose of this study is to study if lidocaine, given intravenously, reduces pain.~   "
221493|NCT00659620|"~     Mesenchymal Stem Cell (MSC) have been shown to have immunosuppressive and repairing~     properties. the investigators will infuse expanded MSC into patients who develop Chronic~     Allograft Nephropathy. The purpose of this study is to find out MSC is more effective in~     preventing organ rejection and maintaining kidney function.~   "
221494|NCT00659607|"~     This Post Marketing Surveillance (PMS) study aims to review the followings by investigating~     the actual practice of MicardisPlus Tablet on the market:~        1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs))~        2. Frequency of incidence and its change in adverse events (AEs)~        3. Factors on the safety profile of the study drug~        4. Factors on the efficacy profile of the study drug~   "
221495|NCT00659594|"~     The primary objective of this placebo-controlled EEC study is to determine the time to onset~     of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.~   "
221496|NCT00659581|"~     The primary objective of this post marketing survey is to prospectively investigate patients~     with hypertension treated with Micardis Tablets (hereinafter this drug) in routine clinical~     settings for 3 years in order to determine the following:~        1. Adverse events and adverse drug reactions under long-term use~        2. Blood pressure measurements during the survey period~        3. Determination of the incidence of cerebrovascular and cardiovascular events under use of~          this drug in routine clinical settings~        4. Patient's lifestyle and background factors that are considered to affect the occurrence~          of cerebrovascular and cardiovascular events~   "
221497|NCT00659568|"~     RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of metformin when~     given together with temsirolimus in treating patients with metastatic or unresectable solid~     tumor or lymphoma.~   "
221498|NCT00659555|"~     This is a two-period study to evaluate the effect of repeat oral dosing of ketoconazole on~     the pharmacokinetics of single dose pazopanib administered as an eye drop~   "
221499|NCT00659542|"~     The purpose of the study is to investigate whether chronic postoperative pain is less~     frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared~     to conventional sutures in inguinal hernioplasty.~   "
221501|NCT00659516|"~     The smart capnography respiratory index is a software tool that constitutes a representation~     of 4 parameters: End Tidal CO2, respiratory rate, O2 saturation and heart rate already~     displayed on a monitor in the form of a single respiratory index integer value ranging from 1~     to 10 with trend information. The index is to be used to identify and display status and~     changes in patient respiratory status in a simple manner based on the summary of changes in~     the 4-above mentioned parameters. the respiratory index is to be used in varied clinical~     environments and is intended for use in adult and pediatric patients.~   "
221502|NCT00659503|"~     The primary objective of this placebo-controlled EEU study is to determine the time to onset~     of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.~   "
221503|NCT00659490|"~     The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by~     the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of~     AZD1940 to placebo (inactive substance) on pain. A number of patients will instead receive~     the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen,~     will be allowed if a need for additional painkillers would arise. A number of patients will~     receive Naproxen as control.~   "
221504|NCT00659477|"~     Aim of the study is to compare two treatment regimens (insulin Lantus as basal insulin vs~     insulin NPH) plus oral antidiabetics in type 2 diabetic patients and confirm superiority of~     insulin glargine. Comparison is focused on: blood glucose (BG) variability of the two~     treatment regimens, quality of diabetes compensation (HbA1c, FBG/Fasting blood glucose), body~     weight development, dose of insulin and occurrence of symptomatic hypoglycaemia and other~     adverse events.~   "
221505|NCT00659464|"~     PURPOSE OF THE STUDY~      This study will explore the use of multi-site NIRS monitoring during tilt table testing,~     combining somatic and cerebral saturations data with hemodynamic data to establish the~     non-invasive assessment of global cardiac output distribution trends.~      HYPOTHESIS / SPECIFIC AIMS~      Study Aims: To evaluate the utility of multi-site NIRS monitoring in the cardiovascular~     hemodynamic assessment of children and adolescents during tilt table testing by establishing~     a non-invasive method to predict cardiac output maldistribution with the use of two-site NIRS~     monitoring in children and adolescents with syncope.~   "
221506|NCT00659451|"~     The anthypertensive treatment with Losartan may have benefits beyond blood pressure reduction~     on myocardial structure and function in hypertensive diabetic patients. We will evaluate the~     effect of losartan treatment on structural characteristics of myocardium in hypertensive~     diabetic patients:~        1. left ventricular mass, intraventricular septal thickness, fractional shortening.~        2. myocardial qualitative alteration and heterogeneity of myocardial tissue that describes~          myocardial texture and echodensity, related to collagen deposition; myocardial~          qualitative alteration will be evaluate by ultrasonic myocardial integrated backscatter~          signals (IBS) both as peak end diastolic signal intensity and as cardiac cyclic~          variation~        3. alteration of diastolic function as studied by Doppler flow velocities across the mitral~          valve (Pulse Wave Doppler) and pulse wave Tissue Doppler Imaging parameters~        4. aortic strain and distensibility (that is in relation with LVH)~        5. epicardial adipose tissue measurement (this parameter is related to the visceral fat and~          may be an easy method to indicate patients with high cardiovascular risk).~   "
221507|NCT00659438|"~     This randomized, double-blind phase II trial is to assess the efficacy and safety of~     bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with~     castration-refractory metastatic prostate cancer without any clinical symptom related to~     disease progression. The study is blinded, and subjects will be randomised (1:1 ratio) to~     either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection~     and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is~     acceptable in this subject population where all subjects will also received bicalutamide 150~     mg o.d. Subjects will continue study treatment until they reach objective biological disease~     progression or unacceptable toxicity or withdrawal of consent or until end of trial (which~     event occurs first). The end of study is fixed 12 months after the last randomised patient's~     first dose of study treatment.~   "
221508|NCT00659425|"~     A dose-escalation study to estimate maximum cummulative dose (MTCD) of CAT-8015 that can be~     safely administered to a participant.~   "
221509|NCT00659412|"~     Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing~     alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension~     with only alefacept + MTX treatment.~   "
221510|NCT00659399|"~     The purpose of this study is to assess feasibility and safety of using once daily~     Fondaparinux Sodium (ARIXTRA®) in patients with ovarian cancer who are in 'clinical~     remission' (no clinical evidence of disease) after chemotherapy but at high risk of ovarian~     cancer recurrence.~   "
221511|NCT00659386|"~     Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with~     progressive cardiac dysfunction and evolution to dilated cardiomyopathy.~      Objective: Whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional~     heart failure therapy achieves virus reduction, thereby resulting in improvement of cardiac~     function.~      Study design: A interventional study of virus presence and cardiac functional capacity before~     and after IVIg therapy.~      Study population: Patients with idiopathic cardiomyopathy and symptomatic heart failure for~     more than 1 year and a significant PVB19 viral load in endomyocardial biopsies (EMB) and~     treated with high dose of IVIg were included.~      Intervention (if applicable): Patients were treated with a total dose of 2 g/kg of immune~     globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 4 consecutive days.~      Main study parameters/endpoints: EMBs: virus (PVB19, enteroviruses, adenoviruses,~     Epstein-Barr virus, human herpes virus-6 and cytomegalovirus), inflammation (lymphocytes an~     macrophages) and fibrosis. Cardiac functional capacity: NYHA classification,~     echocardiographic evaluation (left ventricular ejection fraction, end-systolic diameter,~     end-diastolic diameter).~   "
221512|NCT00659373|"~     RATIONALE: Learning about the long-term effects of adjuvant tamoxifen (T), adjuvant tamoxifen~     with ovarian function suppression (T+OFS), and exemestane with ovarian function suppression~     (E+ OFS) on brain function may help doctors plan cancer treatment.~      PURPOSE: This study is looking at brain function in premenopausal women who are receiving~     adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane~     (E+OFS) with ovarian function suppression (OFS) for early-stage breast cancer on clinical~     trial IBCSG-2402.~   "
221515|NCT00659334|"~     Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating.~     It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such~     as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to~     compare the standard imaging agent, Gadolinium, in imaging brain tumors and the area adjacent~     to the tumor location. Combidex may provide the ability to better see brain tumors and~     inflammatory lesions on magnetic resonance imaging (MRI) scans. Combidex may be useful in its~     ability to cross blood vessels into brain tumors, and because of its size and ability to get~     into the area next to brain tumors, could assist in the treatment of brain tumors with other~     drugs in the future.~   "
221516|NCT00659321|"~     Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial~     dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial~     hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation~     and the risk of atherosclerosis.~   "
221517|NCT00659308|"~     The purpose of this study is to determine whether amniotic membrane transplantation is as~     effective as anterior stromal puncture in the relief of symptomatic bullous keratopathy.~   "
221518|NCT00659295|"~     This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this~     observational study is to evaluate the incidence of serious adverse reactions (SARs) while~     using Levemir® (insulin detemir) under normal clinical practice conditions.~      Study conducted globally in 26 countries. Some countries participated in the study for only 3~     months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey),~     while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece,~     India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and~     United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.~   "
221519|NCT00659282|"~     This study is conducted in Asia, Europe, Japan and North America. The aim of this~     observational study is to evaluate the safety and effectiveness while using NovoMix® 30~     during 26 weeks under normal clinical practice, in the countries participating in the study.~     The primary outcome is the incidence of major hypoglycaemic events reported as serious~     adverse drugs reaction conditions on hypoglycaemic events.~   "
221520|NCT00659269|"~     Many types of chemotherapy may cause nerve damage as a side effect. This neurotoxicity can~     manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain). The~     goal of this study is to determine the efficacy of the combination of vitamin B6 and B12 in~     preventing chemotherapy induced neuropathy.~   "
221521|NCT00659256|"~     This study will examine the effects of treatment for hepatitis C on atherosclerosis, or~     hardening of the arteries. Hepatitis C is a disease of the liver caused by a virus that can~     cause permanent damage to that organ. Treatment can clear the virus in at least half of~     patients and reduce the risk of serious complications of the disease. Atherosclerosis is an~     accumulation of cholesterol and fat in the arteries that can narrow blood vessels, leading to~     chest pain, heart attack or stroke.~      Because the liver controls cholesterol and fat levels in the blood, hepatitis C infection may~     be a risk factor for atherosclerosis by increasing cholesterol and fat in blood vessels.~     Treatment of the hepatitis C may reduce the risk of atherosclerosis and its consequences.~     This study will determine what effect hepatitis C treatment has on the rate of~     atherosclerosis and narrowing of blood vessels and on the risk of heart attack or stroke.~      Patients 30 years of age and older with current or past infection with hepatitis C may be~     eligible for this study. Participants undergo the following tests and procedures:~        -  Questionnaires regarding risk factors for heart disease and stroke~        -  Measurements of blood pressure, heart rate, weight, height, waist and hips~        -  Blood tests~        -  CT scans and ultrasound tests to measure the degree of blood vessel hardening and~          narrowing in the heart and neck region~   "
221522|NCT00659243|"~     The purpose of this study is to evaluate the efficacy in preterm infants following treatment~     with BSSL when administered in pasteurized breast milk.~   "
221523|NCT00659230|"~     This study proposes a multi-site, randomized, double-blind, placebo-controlled clinical trial~     of the dopamine-ß-hydroxylase (DBH) inhibitor, nepicastat, for the treatment of posttraumatic~     stress disorder (PTSD) in outpatients who have previously served in a combat zone during~     Operation Iraqi Freedom and Operation Enduring Freedom (OIF/OEF)or other Southwest conditions~     since 19800. A DBH inhibitor's mechanism of action is to decrease neuronal noradrenaline (NA)~     release by inhibiting DBH conversion of dopamine (DA) to NA. Animal models of PTSD and human~     studies have found a substantial increase in NA activity for these animal models and for PTSD~     in humans. Furthermore, recent clinical studies have improved PTSD hyper-arousal symptoms by~     reducing the NA over-activity using agents like NA post-synaptic antagonists. Key support for~     the proposed study is based on a similar improvement in PTSD symptoms after treatment with~     the DBH inhibitor, disulfiram.~      In the experience of the clinical investigators, the most common chief complaint of the~     OIF/OEF veterans with PTSD is hyperarousal (DSM-IV criterion D symptom cluster). These~     symptoms significantly interfere with social, occupational, and interpersonal function.~     Standard treatments with antidepressants are not fully effective in treating the symptoms of~     PTSD in veterans; thus, new treatments are needed. An intervention, such as nepicastat, aimed~     at reducing hyperarousal, as well as other PTSD symptoms, would have significant impact of~     restoring overall function and quality of life in OIF/OEF veterans with PTSD. Since~     hyperarousal symptoms responded relatively quickly to medications of this type, our study in~     120 outpatient veterans with PTSD will compare nepicastat 120 mg/day vs. placebo in a 6-week~     double-blind, randomized clinical trial (RCT). The veterans will be followed for an~     additional 8 weeks after the RCT, during which, those who have a priori defined positive~     clinical response to the study medication, nepicastat vs. placebo, will be continued on the~     study medication, in order to assess further improvement and safety. Those patients who do~     not have a positive clinical response during the 6 week RCT will be offered the addition of~     the standard first-line PTSD pharmacotherapy, paroxetine, during the 8 weeks extension phase.~     Thus, weeks 7-14 offer an opportunity to evaluate longer-term nepicastat efficacy and to~     compare the treatment response of nonresponders after augmentation with paroxetine.~   "
221524|NCT00659217|"~     Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing~     properties. Manifestations of systemic lupus eryhematosus(SLE) may in most patients be~     ameliorated with medications that suppress the immune system. Nevertheless, there remains a~     subset of SLE patients for whom current strategies are insufficient to control disease. The~     investigators will infuse expanded autologous MSC into patients with lupus Nephritis. The~     purpose of this trial is to evaluate whether this new therapeutical approach will result in~     improvement in the lupus disease.~   "
221549|NCT00658879|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
221829|NCT00655187|"~     This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population~     in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct~     protection offered by the vaccine in hospitalised infants through a case-control study.~   "
221525|NCT00659204|"~     The purpose of this pilot study is to compare the antimicrobial efficacy of silver~     nanoparticle gel to a commercialized alcohol-based hand gel on bacterial counts isolated from~     the hands of 40 volunteers seeded with Serratia marcescens, a surrogate microbial marker.~     Specific aims of this study are: Aim #1: Compare the immediate antimicrobial efficacy of a~     one-time application of silver nanoparticle gel (SilvaSorb , AcryMed, Inc., Portland, OR)~     versus an alcohol-based hand gel (Purell, GoJo Industries, Akron, OH) in reducing transient~     bacterial counts isolated from hands seeded with S. marcescens.~      Aim # 2: Compare the persistent antimicrobial efficacy of a one-time application of silver~     nanoparticle gel (SilvaSorb) versus an alcohol-based hand gel (Purell) over a 10 minute time~     frame in producing a persistent reduction on transient bacterial counts isolated from hands~     seeded with S. marcescens.~      Aim # 3: Compare user acceptability of silver nanoparticle gel (SilvaSorb) versus an~     alcohol-based hand gel (Purell) using a self-assessment questionnaire.~   "
221526|NCT00659191|"~     This study is a Phase I single and repeat dose escalation study of GSK1265744 in healthy~     subjects and a single repeat dose cohort in HIV-1 infected subjects. The study is planned to~     consist of three parts. Part A will enroll two cohorts with a total of 18 subjects in a~     single dose escalation to evaluate safety, tolerability and PK. Part B plans to enroll three~     cohorts of 10 subjects to evaluate repeat doses of GSK126744 on safety, tolerability and PK.~     Part A and B will enroll healthy volunteers. Part C will enroll HIV-1 patients in a single~     cohort of 10 subjects. This cohort will evaluate the effects of repeat dose on safety,~     tolerability, PK and efficacy.~   "
221527|NCT00659178|"~     The purpose of this study is to identify a dose of SB-485232 which is safe, tolerable and~     biologically active when used in combination with pegylated liposomal doxorubicin (Doxil) in~     patients with epithelial ovarian cancer. This study will use a standard treatment regimen of~     pegylated liposomal doxorubicin (Doxil) in combination with rising doses of SB-485232. The~     dose selected from this study will be used in a future studies to evaluate the efficacy of~     this combination.~   "
221528|NCT00659165|"~     Patients with diabetes treated with insulin often gain weight, which may deter patients from~     adhering to insulin treatment. Detemir is one type of long acting insulin approved by the~     Food and Drug Administration for use in people with diabetes. It is similar to other long~     acting insulins (Neutral Protein Hagedorn [NPH], glargine) except that it has been associated~     with less weight gain compared to other types of insulin. The reasons for this are still~     unclear. One possibility is that detemir insulin acts differently than do other insulins in~     affecting how diabetic patients eat meals. The purpose of this study is to determine whether~     appetite and calories eaten during a meal are affected by the type of insulin used to treat~     diabetes. This is a pilot study which means we are gathering preliminary information to~     determine if a larger study can be done.~   "
221529|NCT00659152|"~     Patients affected by acute lung injury-acute respiratory distress syndrome (ALI-ARDS) undergo~     a positron emission tomography (PET) scan in order to analyse lung function.~   "
221530|NCT00659126|"~     This phase II trial studies how well magnetic resonance imaging (MRI) using contrast imaging~     agent ferumoxytol works in comparison to standard imaging agent gadolinium in measuring~     tumors in patients undergoing treatment for brain tumors or other tumors that have spread to~     the brain. Diagnostic procedures, such as MRI, may help find and diagnose disease and find~     out how far the disease has spread. MRI scans use radio waves and a powerful magnet linked to~     a computer to create detailed pictures of areas inside the body. The contrast imaging agent~     ferumoxytol consists of small iron particles taken by the blood stream to the brain and to~     the area of the tumor. It is highly visible on the MRI, and may help visualize the blood flow~     going through the tumor better than gadolinium can. Using a more sensitive and faster 7 Tesla~     (7T) magnet MRI in conjunction with a contrast imaging agent may provide a better way to~     measure tumors than the 3 Tesla (3T) magnet MRI in patients with brain tumors.~   "
221531|NCT00659113|"~     RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy together with more than one drug (combination chemotherapy) may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving S-1 and cisplatin together with~     radiation therapy works in treating patients with stage IIA, stage III, or stage IVA~     esophageal cancer that can be removed by surgery.~   "
221532|NCT00659100|"~     The purpose of this study is to assess consumers' behaviors related to gabapentin self-~     selection and use, relative to warnings and directions for use, as described in the proposed~     over-the-counter (OTC) product label.~   "
221533|NCT00659087|"~     Hospital stays after total joint replacement surgery have been getting shorter over the past~     10 years. This is mostly due to new ways to manage pain and early rehabilitation. To be able~     to go home safely soon after surgery, patients need to:~        -  1) have adequate pain control~        -  2) be able to move through activities of daily living on their own (using aids)~      Femoral nerve block, in combination with pain medications, is one of the new treatment~     strategies that are currently being used at other hospitals in Canada, the United States and~     the United Kingdom. Nerve blocks involve a needle filled with local anesthetic into the nerve~     that allows the feeling of pain around the knee. With good pain management, patients will be~     able to more quickly bend their knee and regain the ability to walk with aids and move from~     sitting and lying positions to standing and walking. Once they can do these activities with~     adequate pain control, they can be discharged from hospital to continue recovery at home. The~     purpose of this study is to examine a new way of managing postoperative pain and encourage~     early knee flexion and mobility, while maintaining pain control for patients after total knee~     replacement. We believe that patients who receive the nerve block in addition to the regular~     pain medication will have more knee flexion at discharge and experience less pain than~     patients who only receive usual pain medications.~   "
221534|NCT00659074|"~     Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg~     ODT~   "
221535|NCT00659061|"~     The purpose of this study is 1) to evaluate the effectiveness in reducing anemia among~     children 6-24 months of age by providing daily micronutrient Sprinkles through the Government~     of Pakistan's Lady Health Worker program; 2) to assist in the monitoring the National~     Sprinkles Pilot Project.~   "
221564|NCT00658684|"~     To assess the long term safety, tolerability and efficacy of fesoterodine in patients with~     OAB.~   "
221537|NCT00659035|"~     Many patients seen at Pain Centers are advised not to drive if they are on long-term opioid~     medications. Although such advice is routinely given considering patients' safety,~     unnecessary restrictions to driving can cause inconvenience to the patients and delay their~     treatment. Such restrictions also pose social and legal questions to patients and physicians.~      The investigators would like to test such patients' ability to drive under oral opioids using~     a driving simulator at the Pain Center. This simulator is like a video game with computer and~     a steering wheel to simulate real life driving. The driving simulator provides measure on~     several outcome measures, such as attention, reaction time, etc. allowing us to specifically~     address question pertaining to any cognitive or behavioral differences.~   "
221538|NCT00659022|"~     Study Hypothesis~      • As well as in animal models as in patients with colorectal cancer resection of the primary~     tumor resulted in increase in vascular density, metabolism and secondary tumor growth of the~     distant metastases. These data strongly suggest an inhibitory effect of the primary tumor on~     the outgrowth of its metastases.~      In this study we investigate whether pre-operative treatment with the anti-angiogenic agent~     bevacizumab and/or chemotherapy before resection of the primary colorectal tumor shifts the~     balance between angiogenic and anti-angiogenic factors in favor of the anti-angiogenic~     factors and results in reduced growth of the liver metastases.~      Eligibility~        -  Histological proven colorectal cancer without signs of bowel obstruction or bleeding~        -  Synchronous liver metastases~        -  WHO performance status 0-1~      Treatment~        -  Arm A: immediate surgery of the primary colorectal tumor, no neoadjuvant therapy~        -  Arm B: neoadjuvant treatment with bevacizumab during 7 weeks prior to surgery of the~          colorectal primary~        -  Arm C: neoadjuvant treatment with CAPOX during 7 weeks prior to surgery of the~          colorectal primary~        -  Arm D: neoadjuvant treatment with bevacizumab and CAPOX during 7 weeks prior to surgery~          of the colorectal primary~      Primary endpoint Difference in response of liver metastases to resection of the primary tumor~     between the experimental groups and the control group, as determined by histopathological~     scoring of vascular density, apoptotic and mitotic index and by measurement of the metabolic~     activity of liver metastases by FDG-PET and SUV measurements.~      Secondary endpoints Toxicity of neo-adjuvant treatment Complications of surgery~   "
221539|NCT00659009|"~     Ascent to altitude lowers oxygen saturation. In addition, sleep lowers oxygen saturation at~     any altitude. In a prior study, we observed that sleep at 8000 feet resulted in pronounced~     reduction in oxygen saturation, but did not result in reduced post sleep neurobehavioral~     performance or impaired sleep quality or quantity. We plan to do a more sophisticated~     physiological evaluation of the respiratory mechanisms responsible for the reduced oxygen~     saturation and determine if there are any adverse consequences to this level of intermittent~     hypoxia. We anticipate that central respiratory apnea is the physiologic mechanism, and that~     there will not be persistent changes in autonomic nervous activity measured by heart rate~     variability.~   "
221540|NCT00658996|"~     Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily~     Toric Contact Lens~   "
221541|NCT00658983|"~     Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of~     chronic lower leg ulcers.~   "
221542|NCT00658970|"~     The purpose of this Phase 1 study is to determine the safety and tolerability of KX2-391 in~     cancer patients.~   "
221543|NCT00658957|"~     The purpose of this study is to determine the safety and efficacy of the topical gentamicin~     collagen sponge (gentamicin sponge) combined with standard of care (daily wound care,~     off-loading, diabetic control and debridement by a physician or podiatrist), compared with~     placebo sponge combined with standard of care, in preventing infection of diabetic lower~     extremity skin ulcers.~   "
221544|NCT00658944|"~     To investigate the role of preoperative maximum urethral closure pressure and Valsalva leak~     point pressure in predicting outcome in patients who underwent trans-obturator tape for the~     treatment of female stress urinary incontinence.~   "
221545|NCT00658931|"~     The primary objective of this pilot project is to evaluate the efficacy of Cymbalta for~     bereavement-associated depression. Participating patients will be treated with Cymbalta in~     doses up to 60mg daily for eight (8) weeks. The primary outcome measure for this study will~     be the 17-item Hamilton Rating Scale for Depression (HRSD-17). In pursuit of this objective,~     we will test the following hypothesis: After eight weeks of open-label treatment with~     Cymbalta for bereavement-associated depression, at least half of the participants will~     achieve remission, as measured by a score of 7 or less on the HRSD-17.~      Secondary objectives of this project are:~        -  To determine the tolerability of Cymbalta treatment among patients with~          bereavement-associated depression (as measured by adverse events and the proportion of~          participants who discontinue Cymbalta before completing eight weeks of study treatment);~        -  To determine the effect of Cymbalta treatment on grief in patients with~          bereavement-associated depression (as measured by the Texas Revised Inventory of Grief~          and the Inventory of Complicated Grief after eight weeks of treatment compared to~          baseline); and~        -  To determine the effect of Cymbalta treatment on health status, pain, and other~          co-morbid symptoms in patients with bereavement-associated depression (as measured by~          the Edmonton Symptom Assessment System and the Medical Outcomes Study 12-item Short Form~          Health Survey administered at Weeks 2, 4, and 8 and compared to baseline).~   "
221546|NCT00658918|"~     The primary objective of this study is to demonstrate the safety of three dose levels of~     ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once~     daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure~     serum concentrations of ciclesonide and its active metabolite under steady state conditions~     at three time points corresponding to the presumed peak and trough exposure after six weeks~     of administration.~      In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of~     treatment at various timepoints and a physician assessment of nasal symptoms at endpoint were~     summarized.~   "
221547|NCT00658905|"~     The purpose of this study is to evaluate the efficacy in preterm infants following treatment~     with BSSL when administered in infant formula.~   "
221548|NCT00658892|"~     RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them.~      PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal~     antibody in treating patients with stage IV melanoma.~   "
221550|NCT00658866|"~     Background/rationale: Ertapenem is an innovative antimicrobial agent, which is approved in~     the European Union for diabetic foot infections of the skin and soft tissue. Although its~     antimicrobial spectrum and activity against ESBL-strains are promising to treat infected~     ulcers associated with diabetes, there is a lack of data on tissue pharmacokinetics of~     ertapenem in this patient population. However, for antimicrobial efficacy it is important to~     show that the antibiotic achieves sufficient concentrations at the site of infection, i.e. in~     tissue. A recent clinical study by Burkhardt et al. (Journal of Antimicrobial Chemotherapy,~     2006) using the microdialysis technique showed that the free tissue concentrations after a~     single dose of 1 g ertapenem are sufficient and adequate to kill most relevant bacteria,~     suggesting efficacy of ertapenem for soft tissue infections. It is well known that there is~     no accumulation of ertapenem in plasma after multiple doses of 1 g every 24 h in patients~     without significantly impaired renal function. The single dose study by Burkhardt et al. also~     suggests that only negligible drug accumulation can be expected in soft tissues of healthy~     young volunteers after multiple doses. However, it was shown for other antibiotics that~     tissue PK may be significantly different under pathologic conditions, leading to impaired~     penetration, but subsequent accumulation after multiple doses due to a longer tissue half~     life than in healthy volunteers. Since the properties of inflamed tissue may diverge from~     those of healthy tissue it is important to evaluate which concentrations of ertapenem are~     reached in inflamed tissue after multiple doses.~      Clinical study: In the present study we will measure the concentrations of ertapenem over~     time in plasma and infected tissue of 10 diabetes patients after multiple doses. The~     microdialysis technique will be used. The ertapenem concentrations will be measured in~     inflamed tissue and in non-inflamed subcutaneous tissue to identify the effect of~     inflammation on pharmacokinetics. The findings of the present study will help to confirm the~     efficacy of ertapenem for the indication of diabetic soft tissue infections.~   "
221551|NCT00658853|"~     4 times 4 minutes interval training with and without hyperoxia is more effective than low~     intensity endurance training.~   "
221552|NCT00658840|"~     The only curative option for pancreatic cancer patients is surgery, but the patients within~     20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation~     therapy is generally used for palliation of unresectable pancreatic cancer patients. So far,~     the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these~     days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an~     alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results~     of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was~     proved to be very effective and safe. The purpose of this trial is to improve the therapeutic~     effects by using proton therapy and chemotherapy concurrently.~   "
221553|NCT00658827|"~     The purpose of this study is collection and analysis of information pertaining to pregnancy~     outcomes in women exposed to infliximab during pregnancy, relative to the background risk in~     similar but non-biologic exposed patients; and information pertaining to health status,~     during the first year following delivery, of infants born to women following prenatal~     exposure to infliximab and their unexposed counterparts.~   "
221554|NCT00658814|"~     This phase II trial is studying the side effects of giving azacitidine together with~     gemtuzumab ozogamicin to see how well it works in treating older patients with previously~     untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can~     block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.~   "
221555|NCT00658801|"~     The only curative option for pancreatic cancer patients is surgery, but the patients within~     20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation~     therapy is generally used for palliation of unresectable pancreatic cancer patients. So far,~     the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these~     days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an~     alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results~     of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was~     proved to be very effective and safe. Proton therapy is a new radiation therapy which~     remaining energy is released when they reach the tumor, delivering the most effective dose of~     radiation and which can minimize the exposure to normal tissues. The purpose of this trial is~     to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.~   "
221556|NCT00658788|"~     The primary objectives of this study are to evaluate the safety & efficacy of consecutive~     treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.~   "
221557|NCT00658775|"~     The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and~     safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the~     treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).~   "
221558|NCT00658762|"~     This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages~     18 and older with generalized anxiety disorder.~   "
221559|NCT00658749|"~     This is a phase one study to evaluate the safety, tolerability, and bioavailability of~     nebulized AIR645.~   "
221560|NCT00658736|"~     This is a triple-blind, parallel group, randomized controlled trial to assess the benefit of~     triamcinolone injection as a therapeutic measure for control of chronic pancreatitis pain.~     The treatment group will undergo EUS-CPB with bupivicaine plus triamcinolone (therapeutic~     block). There control group will undergo EUS-CPB with bupivicaine alone (diagnostic~     block).~   "
221561|NCT00658723|"~     The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to~     SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft~     tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.~   "
221562|NCT00658710|"~     The aim of this multi-center, randomized controlled study is to acquire and compare~     information on gait performance in patients with chronic hemiplegia (six months to two years~     post-stroke) who either continue to attend two physical therapy sessions per week for two~     months or who stop physical therapy sessions for two months.Following the initial screening,~     subjects will be randomized into two groups: one who continues attending two physical therapy~     sessions per week for two months, or the other one who stops physical therapy sessions for~     two months. Before and after those two months, a 3 days recording will be made using an~     ambulatory system called TRIDENT.~   "
221563|NCT00658697|"~     In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early~     multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen~     deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising~     Prostate Specific Antigen (PSA) after treatment of their prostate cancer with surgery or~     radiation)~   "
221569|NCT00658619|"~     Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal~     implant. Patients will receive implant in one eye and sham treatment (meaning no treatment)~     in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1.~     Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the~     safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy~     from age-related macular degeneration. Patients will be followed for up to 2 years.~   "
221570|NCT00658606|"~     Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic~     plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic~     subjects as both modalities have an effect on T cells~   "
221571|NCT00658593|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. It is not yet known whether gemcitabine is more effective when given~     together with or without capecitabine in treating patients with biliary cancer.~      PURPOSE: This randomized phase III trial is studying giving gemcitabine together with~     capecitabine to see how well it works compared with giving gemcitabine alone in treating~     patients with locally advanced, unresectable, or metastatic biliary cancer.~   "
221572|NCT00658580|"~     The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival~     in comparison to a regimen containing etoposide and without platinum derivative.~   "
221573|NCT00658567|"~     This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103)~     compared to placebo in patients with Parkinson's disease psychosis.~   "
221574|NCT00658554|"~     This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal~     healthy volunteers using a randomized crossover design.~   "
221575|NCT00658541|"~     The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem~     tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem~     tartrate tablets)in adult subjects under fed conditions.~   "
221576|NCT00658528|"~     The purpose of this study is to determine the safety and efficacy of Rabeprazole extended~     release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among~     subjects with erosive gastroesophageal reflux disease (GERD).~   "
221577|NCT00658515|"~     This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and~     mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS)~     and evaluate the long term safety profile of the drug. Eligible patients in stable condition~     will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a~     background of standard medication for ACS (including aspirin, antihypertensives and statins).~     The anticipated time on study treatment is 2+ years, and the target sample size is 15,600~     individuals.~   "
221578|NCT00658502|"~     Our study has three parts has three parts, and the main aim of the study is to find out if~     corneal hysteresis was associated with myopia or even a predictor of myopia poor control~     predictor:~        -  Part 1 of our study: patients with anisomeropia whose spherical equivalent refraction as~          measured by cycloplegic autorefraction between the two eyes differ greater than 1.5 D.~        -  Part 2 of our study: Minus spherical equivalent refraction as measured by cycloplegic~          autorefraction.~        -  Part 3 of our study: patients with minus spherical equivalent refraction as measured by~          cycloplegic autorefraction who are under regular atropine for the treatment of~          myopia;patients who are prescribed with atropine treatment are in need of myopia control~          instead of for research interest~   "
221579|NCT00658489|"~     The purpose of Bright Futures is to promote and improve infant, child, and adolescent~     health within the context of family and community. CORNET (COntinuity Research NETwork of the~     Ambulatory Pediatric Association) is a national practice-based research network of resident~     continuity practices, whose mission is to establish a self-sustaining collaborative research~     network among pediatric continuing clinic clinicians who will produce quality research in~     primary care, health care delivery, and education.~   "
221580|NCT00658476|"~     Adolescence is the highest risk period for depression onset. More than 1.3 million youths~     suffer from major depression annually in the United States, and there is evidence for an~     increasing trend. Because many adolescents have their first depressive episode in adolescence~     and adolescent depression often leads to recurrent mood disorders in adults, effective~     treatment during early illness can minimize the negative consequences of initial and repeated~     episodes. Although some antidepressants (particularly Selective serotonin reuptake inhibitors~     (SSRIs)) are effective treatments for juvenile depression, recent warnings about suicide and~     the use of SSRls highlight the need for new and safe treatment for juvenile depression. Data~     in adults suggest that supplementation with polyunsaturated fatty acids (PUFA) might be~     useful for the treatment of depression. The purpose of this study is to investigate the~     safety and efficacy of PUFA for the treatment of adolescent depression.~   "
221581|NCT00658463|"~     Statins have been shown to reduce significantly the risk for cardiovascular events in~     patients with type 2 diabetes and statin therapy is largely recommended in this high~     cardiovascular risk population. However, a residual cardiovascular risk is observed in~     patients with type 2 diabetes treated by statins. This may be due to the fact that statins do~     not correct all lipid abnormalities associated with diabetic dyslipidaemia, such as hyperTG~     and low HDL-cholesterol.~      Rosuvastatin is a statin which, in addition to its efficacy to reduce LDL-cholesterol, has~     been show to decrease significantly plasma triglycerides. However, the effects of~     rosuvastatin on triglyceride rich lipoproteins and HDL remains unknown. The purpose of this~     study is to analyze the effect rosuvastatin 20 mg on the metabolism of triglyceride rich~     lipoproteins and HDL in patients with Type 2 diabetes using and in vivo kinetic study of~     VLDL1-apoB,VLDL2-apoB,IDL-apoB and HDL-apoA1.~   "
221582|NCT00658450|"~     The purpose of this study is to determine whether computerised cognitive rehabilitation~     training improves cognition in children who have had cerebral malaria.~   "
221583|NCT00658437|"~     The trial is designed as a phase II evaluation of the effect of CY-503 on progression free~     survival (PFS) in patients with stage IV malignant melanoma after failure of prior therapy.~     The aim of the study is at least a rate of 25% (PFS >/= 3 months).~   "
239444|NCT00420992|"~     The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with~     placebo for treating moderate to severe chronic pain over a 12 week period.~   "
221584|NCT00658411|"~     The objective of this research study is to determine the safety and feasibility of chelation~     therapy with deferoxamine for patients with iron overload who are receiving a stem cell~     transplant. Patients who have iron overload prior to stem cell transplantation may have more~     toxicity from the transplantation procedure, and thus may benefit from an attempt at iron~     chelation pre- and peri-transplantation. In this study we are examining the use of~     deferoxamine starting 2 weeks to 3 months prior to transplantation and continuing through the~     preparative regimen.~   "
221585|NCT00658398|"~     The purpose of this study is to evaluate the effect of a brief computer program to prevent~     alcohol misuse for patients consulting in an emergency department and screened for alcohol~     misuse.~   "
221586|NCT00658385|"~     Betathalassemia major is a disease of the blood and bone marrow. You were born with it and it~     has made you unable to make normal hemoglobin and red cells. You have been receiving red~     blood cell transfusions all your life. These transfusions do not cure your disease. The~     problem with transfusions is that they contain a lot of iron. With time iron builds up in~     your body and will eventually hurt some of your organs . Because of this buildup of iron ,~     you are taking medicine that helps your body get rid of the extra iron.~      Today, the only other treatment is bone marrow or stem cell transplant. It can only be done~     when a matched donor is available. This is most often a brother, sister, or parent. Bone~     marrow transplant may cure betathalassemia major. If you have a transplant and it is~     successful, you will no longer have the disease. Without a matched sibling or parent, the~     standard treatment is to keep having transfusions.~      In the near future, we will be testing a new treatment for making normal hemoglobin and~     normal red blood cells. We have recreated the healthy hemoglobin gene in a test tube. We are~     able to use it and put it back into cells. This is called gene therapy. We have been able to~     put this gene into the stem cells of mice with thalassemia. These mice were cured. We now~     plan to take that gene and put it into stem cells from people who have betathalassemia major.~     We will then inject those stem cells back into that person's blood.~      In general, we can obtain more stem cells from the blood of a person than from the bone~     marrow . In order to do so, we must give that person a blood growth factor. The growth factor~     stimulates the bone marrow to make more stem cells. That growth factor is called granulocyte~     colony stimulating factor (GCSF), or Filgrastim.~      The purpose of this trial is to find out if the drug GCSF has any side effects on you, and if~     you will make more stem cells in response to it. This trial is not a gene therapy trial. This~     trial will not help your thalassemia.~   "
221587|NCT00658372|"~     This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects,~     ages 18 to 65, with generalized anxiety disorder.~   "
221588|NCT00658359|"~     This is a study that will follow transplant patients from Study A3921030 to monitor for long~     term safety, tolerability and efficacy for 5 additional years, except in Portugal where the~     study will follow transplant patients through Month 36 posttransplant. Patients will continue~     their study medications that were previously assigned.~   "
221589|NCT00658346|"~     Infections with HIV-1 group O are found in 1 to 3 % of persons living with HIV in Cameroon.~     The natural history and treatment response is not well understood. The natural resistance to~     non nucleoside reverse transcriptase inhibitors and their possible low sensitivity to~     protease inhibitors complicate the choice of an adequate treatment options.~      This observational study is aimed at evaluating the antiretroviral treatment response of~     HIV-1 group O infected patients in comparison with HIV-1 group M infected patients. The~     proposed standardized follow-up will facilitate a better understanding of the natural history~     and treatment specificities to improve the patients management.~      This is a non randomized study, open label, with standardized follow-up. A total of 171~     patients~   "
221590|NCT00658333|"~     To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic~     acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms~   "
221591|NCT00658320|"~     The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety~     comparing concentration-controlled everolimus (1.5 mg/day starting dose) with reduced dose~     cyclosporine and corticosteroids versus 2 g/day mycophenolate mofetil (MMF) with standard~     dose cyclosporine and corticosteroids in de novo renal transplant recipients.~      Extension Study (CRAD001A1202E1): Until 24 months after renal transplantation, the study was~     designed to evaluate the long-term safety and efficacy comparing concentration-controlled~     everolimus with reduced dose cyclosporine (Neoral®) and corticosteroids versus mycophenolate~     mofetil with standard dose Neoral® and corticosteroids in de novo renal transplant~     recipients. Beyond 24 months after renal transplantation, the study was designed to provide~     everolimus treatment for patients in everolimus group until everolimus is approved and~     marketed in Japan.~   "
221592|NCT00658307|"~     It has been suggested that the therapeutic effects of repetitive transcranial magnetic~     stimulation (rTMS) are mediated through changes in cortical inhibition (CI). However, in~     healthy subjects the effects of rTMS on CI have been inconsistent. The aim of this study is~     to explore different rTMS - stimulus conditions neurophysiological and molecular mechanisms~     in the human motor cortex. Fifty-six healthy subjects will be randomized into three different~     treatment groups and receive 1 active or sham rTMS session (6000 rTMS pulses) at 90% of their~     motor threshold (MT). Cortical inhibition will be indexed pre and post treatment using~     short-interval intracortical inhibition (SICI), cortical silent period (CSP) and~     long-interval cortical inhibition (LICI).~      Based on previous studies we hypothesize that:~        -  Hypothesis 1: rTMS will result in a greater CI (i.e., prolonged CSP, increased LICI but~          not SICI) compared to sham rTMS.~        -  Hypothesis 2: 20 Hz rTMS will result in a significantly greater CI compared to 1 Hz~          rTMS.~        -  Hypothesis 3: There will be distinctive transcription profiles associated with increases~          in CI from rTMS that can be detected with whole-genome microarray analysis of peripheral~          leukocytes.~   "
221593|NCT00658294|"~     The aim of this study is to evaluate PET-CT and EmII/3-10 serology as potential markers to~     assess the parasitocidal effect of benzimidazoles~        -  Trial with medicinal product~   "
221594|NCT00658281|"~     The goal of this clinical research study is to use the On Board Imager kilovoltage (OBI KV)~     system and cone beam computed tomography (CBCT) scanning or CT-on-rail system to look at how~     well a routine device called an electronic portal imaging device (EPID) can set up a patient~     to receive radiation therapy on the lymph nodes in the neck.~   "
221595|NCT00658268|"~     The primary focus of this study is to investigate whether increased bone density of the graft~     in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative~     to the femur.~   "
221596|NCT00658255|"~     The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort~     with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.~   "
221613|NCT00658034|"~     This is a randomized, placebo controlled study in cancer patients reporting fatigue~     persisting for at least two months following completion of chemotherapy. Subjects will~     receive 6 weeks of either acupuncture or placebo treatment as a means of evaluating whether~     acupuncture reduces chronic fatigue after chemotherapy.~   "
221597|NCT00658242|"~     Craniofacial reconstruction procedures are undertaken in young children to improve~     appearance, prevent functional disturbances, and enhance psychosocial development. These~     procedures involve wide scalp dissections and multiple osteotomies and have been associated~     with significant morbidity. The most commonly seen perioperative complications are associated~     with the rate and extent of blood loss. This prospective observational registry will be a~     research tool which will provide a means to evaluate perioperative management of these~     children at CHOP.~   "
221598|NCT00658229|"~     The purpose of this study is to determine the effectiveness of a four months strength~     training program on physical and psychological health in patients with prostate cancer during~     androgen deprivation therapy. It is hypothesized a beneficial effect of the intervention on~     physical and psychological health in patients with prostate cancer treated with androgen~     deprivation.~   "
221599|NCT00658216|"~     The purpose of this study is to test the usefulness of measuring plasma brain natriuretic~     peptide (BNP) for diagnosis and prognosis in very elderly dyspneic patients.~   "
221600|NCT00658203|"~     The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT)~     achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical~     procedure.~      PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak~     Endocardial Acceleration sensor features onboard the device.~   "
221601|NCT00658190|"~     The purpose of this study is to assess whether a system that couples automated screening of~     Pap Tests with transmission of machine selected digital images, and review by cytologists at~     a remote location, performs to a clinically effective standard of accuracy.~   "
221602|NCT00658177|"~     Study to investigate the efficacy and safety of Vardenafil~   "
221603|NCT00658164|"~     Patients will be randomized to lifestyle changes alone or lifestyle changes associated with~     iron depletion.~      Iron depletion will be achieved by removing 350 cc of blood every 10-15 days according to~     baseline hemoglobin values and venesection tolerance, until ferritin < 30 ng/ml and~     transferrin saturation < 25%. Weekly phlebotomies will be allowed for carriers of the C282Y~     HFE mutation. Smaller phlebotomies (250 cc) will be allowed for carriers of beta-thalassaemia~     trait. Maintenance phlebotomies (as much as required) will then be instituted to keep iron~     stores depleted (ferritin < 50 ng/ml and transferrin saturation < 25%, MCV <85 fl). Before~     starting treatment, patients will undergo ECG, and in the presence of hyperglycemia or~     hypertension also echocardiography (see exclusion criteria).~      Change in diabetes medication dosage or start of new therapy will be allowed for HbA1C values~     <6% or ≥ 7%. According to accepted criteria, previously untreated patients should be treated~     with metformin. If possible, newly diagnosed hypertension should be treated with~     Ace-inhibitors.~   "
221604|NCT00658151|"~     The hypothesis is that there are unique sonographic characteristics of antibiotic-associated~     diarrhea. We will compare the ultrasound findings in patients who received antibiotics and~     developed diarrhea to toxin analysis for clostridium difficile in stool in order to find~     differences in the sonographic findings in the positive and negative cases.~   "
221605|NCT00658138|"~     The purpose of this study is to evaluate the performance of a new dental adhesive system in~     the restoration of Class I and Class II cavities in adult teeth.~   "
221606|NCT00658125|"~     Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75~     million people in the US and Canada. People with AD have difficulty remembering general facts~     and previously experienced autobiographical events. Animal and human research demonstrates~     that this type of memory depends on neural function within specific brain areas, and that it~     may be possible to enhance memory with electrical stimulation of these brain areas. We have~     recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances~     memory in a human.~      Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by~     activating memory circuits in the brain.~      Methods: Six early AD patients will take part in a phase I clinical study over a 1-year~     period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and~     neurological testing, and brain imaging to detect alterations in brain activity induced by~     stimulation. These assessments will occur one month before surgery, then again at one month,~     6 months, and 12 months after surgery.~   "
221607|NCT00658112|"~     The purpose of this research study is to see how often benzoyl peroxide is applied for acne.~     Use of medication was monitored electronically.~   "
221608|NCT00658099|"~     This trial is conducted in Europe. The aim of this observational study is to evaluate the~     change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal~     clinical practice conditions.~   "
221609|NCT00658086|"~     To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected~     lung transplant patients~   "
221610|NCT00658073|"~     The goal of this study is to evaluate autologous MSCs as an alternative for antibody~     induction therapy in renal transplantation.~   "
221611|NCT00658060|"~     Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology,~     characterized by recurrent episodes of fever, peritonitis and/or pleuritis.~      Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by~     abdominal pain.~      Another clinical manifestation in patients with FMF is exertional muscle pain, usually in the~     thigh, which appears even after minor exercise or physical activity in young patients with~     generally good health (other than FMF) and in good physical condition. Some patients also~     complain of ankle edema after relatively minor physical activity, which subsides after a~     night rest. Although these manifestations are quite common in FMF patients and form part of~     the minor criteria for the diagnosis, the etiopathogenesis has not been examined.~      The purpose of the suggested study is to evaluate and characterize the anatomical and~     biochemical changes in the muscles of the thigh and in the ankle triggered by physical~     activity in FMF patients complaining of exertional lower leg myalgias and edema after minor~     physical exercise.~   "
221612|NCT00658047|"~     The purpose of this trial is to assess the clinical effect of CH-1504 at doses of 0.25, 0.5~     and 1.0 mg per day in patients with active rheumatoid arthritis by determining the proportion~     of patients achieving an American College of Rheumatology (ACR) 20% improvement response.~   "
222203|NCT00650273|"~     The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600~     mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg)~     dose administered under fasting conditions.~   "
221614|NCT00658021|"~     The primary objective of this study is to test the hypothesis that glycemic control, as~     measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is~     superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2~     diabetes who are naïve to antidiabetes agents, or patients who are being treated with~     metformin, an SU, or a combination of metformin and an SU~   "
221615|NCT00658008|"~     This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects,~     ages from 18 to 65, with generalized anxiety disorder.~   "
221616|NCT00657995|"~     This study evaluated a closed-loop system providing continuous monitoring and strict control~     of perioperative blood glucose following pancreatic resection.~   "
221617|NCT00657982|"~     The mechanisms responsible for the development of hormonal refractory prostate cancer (HRPC)~     have been elusive. Genetic inactivation/loss of the PTEN tumor suppressor gene occurs in~     30-60% of advanced prostate cancers and in 20% of the localized form. Researchers hypothesize~     that PTEN loss is a landmark genetic event in prostate cancer progression into the fatal HRPC~     form. One consequence of PTEN loss is activation of the oncogenic Akt and phosphorylation of~     downstream Akt targets including mTOR. mTOR controls many important cellular processes~     including cell cycle regulation.~      We propose to evaluate pharmacodynamic assessments of the mTOR inhibitor RAD001 in~     intermediate and high risk prostate cancer patients in the neoadjuvant setting. Patients will~     be admitted to 6 weeks treatment with RAD001 10 mg/day followed by either radical~     prostatectomy or radiotherapy combined with hormonal treatment. Immunohistochemistry with~     antibodies for phosphorylated p70S6K , pS6, Akt as well as antibodies for VEGF, BCL2 and PTEN~     in prostate cancer tissues before and after 6 weeks RAD001 treatment will be performed.~     Additionally, Patients will be evaluated by FDG-PET scan before (as baseline) and after~     RAD001 treatment. A link between mTOR signaling and glycolysis regulation was established and~     may provide a mechanism to assess drug-target interaction of RAD001 in prostate cancer.~      The secondary endpoint of the trial will be to determine the response proportion to RAD001~     treatment by assessing time to biochemical failure followed by radiation therapy or radical~     prostatectomy. The data will be compared to a matched cohort of high and intermediate-risk~     prostate cancer patients admitted to the same treatments modalities without receiving RAD001.~   "
221618|NCT00657969|"~     The main purpose of this study is to look for genetic and environmental risk factors of~     cervical artery dissections, a major cause of ischemic stroke in young adults, in a large~     multicenter case-control trial~   "
221619|NCT00657956|"~     Hip and knee replacement arthroplasty are profoundly successful operative interventions,~     however, some joint replacements do fail and the life expectancy of a hip or knee~     arthroplasty is finite. This fact has largely been responsible for the continued development~     of new devices and techniques for joint arthroplasty surgery. Unfortunately, the introduction~     of new technologies and devices is not a benign process, and even subtle changes to existing~     implants can have a disastrous effect on patient outcome. The fact that new technologies and~     devices can lead to poor results has led some authors to advocate a phased introduction of~     new technologies. A key component of the phased introduction approach advocates the use of~     roentgen stereophotogrammetric analysis (RSA) early in the testing process. RSA is a highly~     accurate radiographic technique developed in Lund, Sweden and has for some time been the gold~     standard in Europe for assessing the stability of implants within bone. The purpose of this~     study is to utilize RSA to elucidate the migration patterns of the foam metal backed Advance~     Knee Arthroplasty components during the first 2 years postoperatively and to determine in~     what proportion of cases adequate fixation is achieved. In addition outcome measures will be~     recorded to quantify changes in functional status of subjects after surgery and bone mineral~     density will be monitored to quantify bone in-growth around the implant. Migration patterns~     will be compared to results obtained from previous studies of uncemented and cemented total~     knee arthroplasty components conducted at this centre.~   "
221620|NCT00657943|"~     Type 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to~     macrovascular disease. The primary objective of the study is to evaluate the effect of an~     18-month treatment with metformin versus placebo in combination with one of three insulin~     analogue regimens following a treat-to-target principle. The primary outcome measure is~     change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900~     patients with T2DM and HbA1c above 7.5% will be included.~   "
221621|NCT00657930|"~     This study is conducted in Europe. The aim of this observational study is to gain practical~     experience with once-daily Levemir administration in type 2 diabetes patients who were~     previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of~     their ICT under normal clinical practice conditions in Hungary.~   "
221622|NCT00657917|"~     The primary objective of this protocol is to treat laboratory confirmed cutaneous~     leishmaniasis with WR 279,396 in military health care beneficiaries. In this study cutaneous~     leishmaniasis is defined as Old World Leishmaniasis if acquired in the Southwest Central~     Asia/Middle East.~   "
221623|NCT00657904|"~     The purpose of this trial is to study the effect - in terms of time to progression and~     overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in~     subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the~     prostate gland.~   "
221624|NCT00657891|"~     We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood~     tests will be done in a test tube to see if they react differently before and after~     treatment. The blood cells will be mixed with to whatever the person is allergic.~   "
221625|NCT00657878|"~     This study aims to test the hypothesis that the artificial prolongation of the platinum-free~     interval with a non-platinum treatment will improve the effectiveness of overall therapy in~     patients with ovarian cancer progression occurring 6-12 months after first-line treatment~     with a platinum-derivative.~   "
221626|NCT00657865|"~     This project investigates the effect of ACE-inhibition on cellular metabolism by gene~     expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril~     intake.~      This should contribute to our understanding of the pathomechanisms involved in diabetes and~     the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome.~   "
224817|NCT00615667|"~     Exploring the efficacy and safety of Tacrolimus on refractory nephrotic syndrome ; Acquiring~     the experience of Tacrolimus on the treatment of refractory nephrotic syndrome in Chinese~     patients.~   "
221627|NCT00657852|"~     The aims of this study are to prospectively evaluate the efficacy of two intravenous~     infusions of pamidronate 90 mg, associated with calcium and calcidiol, in the early~     post-transplant period, on bone loss in liver transplant recipients, and to asses the safety~     of this treatment.~   "
221628|NCT00657839|"~     Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign~     Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve~     the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily~     administration of 10 mg BID.~   "
221629|NCT00657826|"~     The initial clinical investigation titled ATS 3f(r) Aortic Bioprosthesis Model 1000 Study,~     was a prospective, non-randomized, multi-center study designed to evaluate the the safety and~     effectiveness obtained from 800 patient years using a common clinical protocol. Twenty-three~     (23) sites internationally and in the United States combined enrolled 405 patients. The~     objective of the study was to evaluate the safety and effectiveness of the ATS 3f(r) Aortic~     Bioprosthesis Model 1000 equine pericardial prosthesis in a a patient population undergoing~     isolated aortic valve replacement of his / her native aortic valve, or replacement of a~     failed prosthesis with or without concomitant procedures.~      Addendum: After receiving PMA approval in October of 2008 of the 21mm-29mm sizes, this IDE~     was expanded to comply with the conditions set forth in the approval notice. Study Protocol~     S2001 Rev. E is a continuation of the original protocol, but is only enrolling subjects who~     require a 19mm ATS 3f(r) Aortic Bioprosthesis, Model 1000 and is described as A~     multi-center, non-randomized trial, designed to obtain 800 patient years. Each enrolled~     patient will be followed for a minimum one year and annually thereafter until size 19mm~     product approval or study cessation. Preoperative, discharge or 30 days (which ever comes~     last), 3-6 month, and annual follow-up data are required.~   "
221630|NCT00657813|"~     The main objectives of this proposal are as follows:~      To assess the dynamic uptake and washout of 123-I MNI-330, a potential imaging biomarker for~     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in~     similarly aged Alzheimer's (AD) subjects and healthy controls~      To perform blood metabolite characterization of 123-I MNI-330 in healthy and AD subjects to~     determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-330 as a~     single photon computed tomography (SPECT) brain imaging agent~      Evaluate the test/retest reproducibility of 123-I MNI-330 and SPECT in AD subjects and~     healthy controls~   "
221631|NCT00657800|"~     Patients will be recruited from comparable inpatient units that have been randomized as~     either interventional (Group 1) or control (Group 2) units. Patients in the interventional~     group will receive a comprehensive individualized diabetes education program coordinated by a~     certified diabetes educator. Patients in Group 2 will receive education from clinical staff~     as it is typically provided. Assessment of patient satisfaction with both inpatient and~     outpatient care, quality of life, and diabetes self-management skills (including emergency~     room visits and readmissions) will be measured using surveys completed during hospitalization~     and 4 months after discharge to determine any differences between the two groups.~   "
221632|NCT00657787|"~     The overall objective of this project is to develop the first longitudinal registry of~     combat-exposed men and women with PTSD. This registry will provide essential data on the~     natural history, including progression and remission, and outcomes associated with PTSD in~     military service men and women who have utilized the Department of Veterans Affairs (VA)~     health care system. Additional goals of this project are to determine risk factors for PTSD~     among combat-exposed service men and women (by incorporating a combat-exposed non-PTSD group~     of veterans into analyses), and to assess the joint effects of combat exposure and PTSD on a~     broad range of outcome measures (by incorporating a non-combat-exposed group of veterans into~     analyses). Thus, the registry will allow an evaluation of current theoretical models of~     symptom development and progression in a large sample of service men and women who utilize~     the VA medical system.~      In addition to the PTSD registry, we will collect information on two comparison groups of~     OIF/OEF-era veterans to conduct nested case control studies within the general VA health care~     utilization database. First, a comparison group of combat veterans who are high utilizers of~     VA medical care, but who have not received a diagnosis of PTSD will be identified. This group~     will be used in analyses to identify risk factors for PTSD. Additionally, the rate of PTSD~     symptoms will be evaluated in this comparison group to estimate the prevalence of missed PTSD~     diagnoses among combat veterans with high rates of service utilization, and the resulting~     impact on utilization and outcomes. A second comparison group will consist of veterans with~     similar service record and demographic backgrounds, who were not deployed to the OIF/OEF war~     zones. Thus, the proposed project will create a PTSD registry from the VA database to assess~     the natural history and progression of PTSD in combat veterans from OIF/OEF and also to~     conduct case-control studies nested within the VA database. The case-control comparisons will~     be used to evaluate key hypotheses related to the specific aims of the overall project.~   "
221633|NCT00657774|"~     The medications being used in this study are individually approved by the Food and Drug~     Administration (FDA). The medication under investigation is a combination of the two~     medications in one inhaler. The purpose of the study is to determine how the medication~     affects the amount, if any, of cortisol produced by the adrenal glands.~   "
221634|NCT00657761|"~     The metabolic effects of T-20 are not completely known, since the drug is used in combination~     with other antiretroviral agents. A short-term study in healthy volunteers, with a~     double-blind crossover design vs. placebo will illustrate if there may be some direct~     metabolic effects without the influence of HIV infection and the concurrent use of other~     drugs.~   "
221635|NCT00657748|"~     The aim of this study is to determine whether oral supplementation with lithium and acetate~     may improve the biological and clinical prognosis in patients with Canavan Disease.~   "
221636|NCT00657735|"~     The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in~     subjects with bipolar depression , currently treated with mood stabilizer and previously~     unsuccessfully treated with antidepressant medications~   "
221637|NCT00657722|"~     In order to improve effectiveness of the surgical operation thanks to a reduction in the rate~     of failure, this study will allow us to identify predictive angiographic and CT finding of~     surgical failure, starting from standardized reading grids, in order to have a better~     selection of the operable patients.~   "
221638|NCT00657709|"~     The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to~     lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with~     routine infant vaccines.~   "
221713|NCT00656708|"~     The purpose of this study is to determine whether Kerlix AMD gauze will decrease the~     incidence of healthcare associated infections in burn patients. Kerlix AMD gauze will be~     applied to all patients with open wounds admitted to the burn unit during the prospective~     portion of the study. All consenting patients will be assessed for hospital associated~     infections and outcomes. We hypothesis that burn patients will have a decreased number of~     hospital associated infections compared to historical controls.~   "
224870|NCT00614965|"~     This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the~     second-line treatment of patients with stage IIIB/IV NSCLC~   "
221639|NCT00657696|"~     Within every primary care clinic is a small team of people who provide care to a group of~     patients who consider this clinic to be their medical home. Rapid advances in medical~     knowledge and technology require that these teams constantly adapt so that they can provide~     the best care to their patients. The goal of this study is to examine how people in these~     primary care teams learn and relate to each other as they change an adapt. This will be done~     by observing and interviewing people who work in these teams and by giving them and their~     patients a survey to fill out. We will then look at the performance of these clinics to see~     if it is related to how they learn and the quality of their relationships. Our ultimate goal~     is to design effective interventions that will improve the quality and outcomes of care~     received by Veterans in primary care outpatient clinics within the VHA.~   "
221640|NCT00657683|"~     The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity~     of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect~     humans from infection.~   "
221641|NCT00657670|"~     This research project will compare two methods of correcting refractive error (long or~     short-sightedness) with spectacle lenses. The primary outcome is the proportion of the~     population requiring spectacle correction who's needs are met through each scheme. Secondary~     outcomes are the cost effectiveness of these schemes and development of guidelines for~     identification of those amongst the population suitable for 'ready-made' spectacles.~      There are two sites involved in this research. Those with uncorrected refractive error will~     be identified by their distance vision. Those who have impaired vision (at least 20/40) which~     improves with spectacles will be invited to participate in this research. Participants will~     be randomly allocated to one of two groups. The first group will receive spectacles with full~     correction in both eyes and the second group will receive spectacles from a limited~     inventory. The two schemes will be compared by how many people continue to use the~     spectacles, vision with the new spectacles, change in the level of visual functioning and~     quality of life after wearing new spectacles for one month. At the one month visit, if the~     spectacles provided are not useful, one new pair of custom spectacles will be dispensed.~   "
221642|NCT00657657|"~     In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at~     0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for~     immunological memory to hepatitis B vaccine via assessment of the response to a vaccine~     challenge dose.~   "
221643|NCT00657644|"~     To find out more information on how effective and safe vardenafil is at treating impotence in~     men living in Russia.~   "
221644|NCT00657631|"~     Symptoms of schizophrenia have historically been treatment resistant despite advances in~     psychopharmacology. Acceptance and Commitment Therapy (ACT) has been shown through some~     preliminary research to be effective with psychotic symptoms (Bach & Hayes, 2002). ACT is~     considered part of the third wave of CBT along with Dialectical Behavior Therapy (DBT;~     Linehan, 1993) and Mindfulness-based Cognitive Therapy (MBCT; Segal, Williams, & Teasdale,~     2001). The target of change in ACT is acceptance of symptoms as experiences that a person can~     have without experiencing distress, and while living a life in accordance with one's values.~      The current study assessed the effectiveness of ACT (8 sessions) for delusions. Participants~     received treatment as usual throughout the study. The intervention followed the protocol of~     ACT described in Hayes, Strosahl and Wilson (1999) in which treatment will consist of~     building acceptance, willingness, and commitment to change, clarifying values, defusion of~     thoughts and feelings, as well as defusion of self. These therapeutic aims attempted to be~     achieved by the practice of various exercises in and out of session as well as the discussion~     of various metaphors within session. It was hypothesized that participants will exhibit~     decreased distress due to delusions, decreased delusional conviction and a reduction of~     overall anxiety levels from participants' baselines.~   "
221645|NCT00657618|"~     Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the~     world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a~     threat for military soldiers in areas where this disease is found. Sodium stibogluconate~     (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND)~     product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and~     visceral leishmanias. This drug is not licensed for commercial use in the United States~     because of very limited need for the product in the U.S.A. The primary objective of this~     protocol is to collect safety data on the use of Pentostam for treatment of~     laboratory-confirmed leishmaniasis with SSG 20mg/kg/d IV for 10 days or 20 days and visceral~     and mucocutaneous leishmaniasis with SSG 20mg/kg/d IV for 28 days.~      Due to low enrollment, the protocol was later amended in version 11 submitted 19May2010 in~     serial no. 0096) to remove the efficacy objective and only collect safety data for enrolled~     subjects. Prior to this amendment, data were entered on case report forms (CRFs). Per the~     Sponsor's discretion, CRFs were no longer required and protocol-specified treatment details~     and safety assessments were recorded in the patients' medical records (study file) only. No~     data entry or statistical analyses of patient data was conducted.~   "
221646|NCT00657605|"~     This study will test the hypothesis that leptin contributes to the regulation of the dynamics~     of human endocrine function.~   "
221647|NCT00657579|"~     To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering~     intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular~     Hypertension~   "
221648|NCT00657566|"~     The major hypothesis to be tested is that the treatment of intraabdominal infections that~     have been adequately treated operatively or by percutaneous techniques with three to five~     days of antibiotics will result in outcomes equivalent to the current standard where~     treatment is carried out until the patient has returned to normal (normal white blood cell~     count, temperature, and intestinal function), and that patients treated for three to five~     days will receive fewer days of antibiotics than the control group that has traditionally~     received seven to 14 days of treatment.~   "
221649|NCT00657553|"~     To evaluate whether using the drug bortezomib at the start of remission will prevent relapse~     for a longer period of time.~   "
221830|NCT00655174|"~     The purpose of this study is to determine if fluvoxamine or sertraline reduce the fequency or~     severity of aggressive behaviour, obsessive symptoms, or anxiety in young children with~     autism. The within-patient variability in this patient population using standard~     neuropsychological instruments will also be determined and a predictor model for SSRI~     responsitivity based on baseline neuropsychological testing will be developed.~   "
221650|NCT00657540|"~     The purpose of this study is to test the efficacy and safety of a new antivenom called~     Analatro® for treating black widow spider bites in patients who present to a hospital~     emergency room within 24 hours of symptom onset. This study will be a phase III,~     multi-center, double-blind, randomized controlled study that takes place in emergency~     departments. The primary aim of this study is to determine the proportion of patients in~     which pain control was not achieved by 48 hours post treatment. Secondary aims are as~     follows: 1) a reduction in pain intensity at the end of the treatment phase compared to~     baseline; 2) the proportion of patients with a clinically significant decrease in pain~     intensity at 30 minutes post-treatment; 3) the proportion of patients in which drug-related~     adverse events occurred; and 4) to determine if serious, drug-related adverse events in~     Analatro-treated patients occurred at a rate greater than one in 10 (10%).~   "
221651|NCT00657527|"~     The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8~     weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with~     coronary artery disease.~   "
221652|NCT00657514|"~     After 6 weeks of maximal Ranolazine therapy, tissue hemoglobin desaturation kinetics will~     change compared to placebo in patients with chronic angina and peripheral arterial disease.~   "
221653|NCT00657501|"~     This study is a randomized, double-blind, placebo-controlled, multi-center study of the~     safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal~     women.~   "
221654|NCT00657488|"~     The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial~     treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with~     thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs)~     in the treatment of refractory or relapsed multiple myeloma after at least two courses of~     treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the~     safety of the treatment.~   "
221655|NCT00657475|"~     The purpose of this study is to demonstrate superiority on postoperative bleeding from the~     use of a heparin half dose compared to a conventional dose, under mini-extra corporeal~     circulation, without increased risk to the patient.~   "
221656|NCT00657462|"~     This project will study whether reminder prompts increase PAML Builder application feature~     utilization.~   "
221657|NCT00657449|"~     The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the~     signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated~     the disability status, tolerability and safety of these treatments.~   "
221658|NCT00657436|"~     The purpose of the study is the evaluation of multiple biomarkers related to acute coronary~     syndromes, including myeloid-related protein 8/14 (MRP 8/14), along with established clinical~     markers, for early diagnosis and risk stratification in patients presenting with acute chest~     pain at the emergency department.~      Study hypothesis: MRP 8/14, alone or together with other established or new biomarkers,~     increases the earliness, sensitivity, and specificity of diagnosing acute coronary syndromes.~   "
221659|NCT00657423|"~     To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of~     non-small cell lung cancer, patients will be randomly assigned to the group one (endostar~     combined with docetaxel and cisplatin) and group two (docetaxel and cisplatin).~        -  The serum concentrations of Endostatin,VEGF and bFGF are determined.~        -  Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor~          cells (CPCs) will be measured by flow cytometer.~        -  Statistical analysis will be applied to study the relationship between the levels of~          Endostatin, VEGF, bFGF, CECs and CPCs and the clinical outcomes such as objective~          response rate(ORT), time to progression (TTP), mean survival time(MST), toxicity and~          quality of life (QOL).~   "
221660|NCT00657410|"~     RATIONALE: Drugs, such as prednisone and dexamethasone, may change the immune system and be~     an effective treatment for primary immune thrombocytopenic purpura. It is not yet known which~     drug is more effective in treating primary immune thrombocytopenic purpura.~      PURPOSE: This randomized phase III trial is studying high-dose dexamethasone to see how well~     it works compared to standard-dose prednisone in treating patients with newly diagnosed,~     previously untreated primary immune thrombocytopenic purpura.~   "
221661|NCT00657397|"~     The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved~     through the possibility of prescribing buprenorphine in primary care has been successful in~     reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV.~     To date, methadone in France can only be initialised in drug centres but GPs can prescribe~     methadone after stabilisation of dosages.~      This study was born as an answer to a request from the French Minister of Health that~     supports the initialisation of methadone in primary care in order to improve coverage by OST~     (now 70%) in drug users.~   "
221662|NCT00657384|"~     Blood loss was reported as a prognostic risk factor of morbidity and overall survival after~     hepatic resection. The aim of this study prospective randomized was compare the efficacy of~     the administration of tranexamic acid versus placebo to reduce perioperative bleeding after~     major hepatectomy (> 3 hepatic segments).~   "
221663|NCT00657371|"~     The purpose of this study is to demonstrate efficacy of the Avantis Third Eye Retroscope~     auxiliary imaging system.~      The primary objective of this study is to assess the degree to which incorporating the Third~     Eye Retroscope auxiliary imaging system in a screening colonoscopy setting results in the~     detection of additional polyps.~      Specifically, the primary goals are to estimate (1) the proportion of polyps detected under~     this protocol that would have been missed without the Third Eye Retroscope, and (2) the~     proportion of patients found under this protocol to have polyps who would have incorrectly~     been classified as polyp-free had the Third Eye Retroscope not been used.~   "
221664|NCT00657358|"~     The purpose of this study is to study if lidocaine, given intravenously, reduces pain.~   "
221739|NCT00656370|"~     Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates~     of different solutions subcutaneously (SC) infused and preceded by human recombinant~     hyaluronidase (hylenex) 150 units.~      In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR)~     solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one~     thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150~     units of hylenex.~      In Stage 2, the comparison will be NS solution and buffered NS solution.~   "
221665|NCT00657345|"~     Significant progress has been made in the treatment of women with Her2 positive breast cancer~     who are treated with trastuzumab, a humanized monoclonal antibody that inhibits Her2. Despite~     this progress not all patients with Her2 positive metastatic breast cancer respond to~     trastuzumab and patients with metastatic disease who do respond usually develop progressive~     disease during treatment with trastuzumab. The mechanism of such resistance is unknown. We~     propose to investigate the mechanism of trastuzumab resistance in Her2 positive breast~     cancer. The hypothesis to be examined in the basic science section of this study is that~     IRS-1 and IRS-2 are modifiers of HER2 signaling and that these adapter proteins could be~     predictive indicators of treatment response to Herceptin in patients that are candidates for~     this targeted therapy. The connection between IRS-1 and IRS-2 expression and Herceptin~     response and clinical outcome in HER2 positive human breast tumors will be evaluated to~     determine if IRS expression correlates with resistance to Herceptin therapy and with the~     aggressive behavior of these tumors. This study will establish if the IRS proteins influence~     HER2 function in tumors and if they are predictive markers for evaluating treatment options~     for HER2 positive patients.~   "
221666|NCT00657332|"~     This research involves the study of neuroendocrine tumors in order to better understand how~     the disease grows and spreads. This study requires will use tissue collected from from~     biopsies performed during your regular medical care (i.e. tissue leftover after your~     diagnosis has been made) and/or blood and urine samples. This study may lead to the~     development of special materials that could be used, in the future, to treat neuroendocrine~     tumors or to follow the response of neuroendocrine tumors to treatment~   "
221667|NCT00657319|"~     This observational study is conducted in Europe. The objective of this retrospective~     observational cohort analysis is to assess the changes of glycaemic control and quality of~     care in those Type 2 diabetic patients who were previously treated with Mixtard® insulins~     after 6 months of their switch to analog premix insulin NovoMix® 30 therapy.~   "
221668|NCT00657306|"~     Relative adrenal insufficiency (RAI) is an well known condition in patients with septic~     shock. Liver failure (including chronic liver failure)and sepsis are both characterized by~     hyperdynamic circulatory failure (with low arterial pressure) and high levels of~     pro-inflammatory cytokines.~      Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of~     this study is to evaluate the incidence of RAI in the different settings of ascites in~     cirrhosis and the usefulness of hydrocortisone in this context.~   "
221669|NCT00657293|"~     Patients with chronic lung disease often report shortness of breath when they use their arms~     for simple activities of daily living such as dressing, lifting, shaving, bathing and~     brushing their hair and teeth. The best type of arm training for these patients is still~     unknown.~      The objectives of this study are to:~        -  develop a feasible and safe arm training program (ATP) for these patients;~        -  examine the effects of this ATP on quality of life, arm function, arm exercise capacity~          and symptoms during activities of daily living;~        -  examine the effects of ATP on breathing responses during arm exercises.~   "
221670|NCT00657280|"~     This study will investigate the effects of sitagliptin, a medicine commonly used to treat~     type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure~     which is not due to heart attacks. We hope to determine whether improving the heart's ability~     to use glucose in the blood may help improve the function of the heart as well. If so, this~     may suggest that even people who do not have frank diabetes but who do have heart failure may~     benefit from using this medication.~      This study will also investigate the effect of sitagliptin on the body's use of sugar, and of~     the effect of sitagliptin on blood flow to the heart.~   "
221671|NCT00657267|"~     Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed~     glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas.~     We will be using a different dose and schedule than the FDA approved dose and schedule. The~     purpose of this study is to determine if patients that have failed standard temozolomide~     treatment will respond to temozolomide when given at a different dose and schedule (21 days~     every 28 days).~   "
221672|NCT00657254|"~     The study was designed to allow for the continuation of treatment with Sorafenib as a single~     agent to those patients who participated in a previous Sorafenib study that had reached its~     designated end-date and who were, in the opinion of the Investigator and the Sponsor, still~     benefiting from treatment.~   "
221673|NCT00657241|"~     14-week single blind, double baseline, forced-titration, cross-over comparison of the cardiac~     benefits of Coreg CR compared to valsartan added to existing ACE inhibition~   "
221674|NCT00657228|"~     To determine if intravenous unfractionated heparin (with standard therapy) for treatment of~     anaphylaxis results in faster time to recovery.~   "
221675|NCT00657202|"~     The purpose of this research study is to determine if ranibizumab can prevent the growth of~     neurofibromas. We will also be collecting extra blood and serum samples to help us learn more~     about NF1. Ranibizumab is a drug that affects the development of blood vessels that feed~     tumors. It targets a substance in the body called VEGF (Vascular Endothelial Growth Factor).~     VEGF helps tumors to grow and survive by supporting the growth of blood vessels that bring~     nutrients to the tumor. VEGF is made by cancerous tumors and also by non-cancerous tumors~     such as neurofibromas.~   "
221676|NCT00657189|"~     The primary objective of this study is to evaluate the safety and tolerability of multiple~     doses of MEDI-545 in subjects with moderately to severely active Lupus.~   "
221677|NCT00657176|"~     This is an open-label, non-randomized, single-center, dose-escalation study in patients with~     advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned~     for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in~     patients with advanced solid tumors to evaluate the recommended dose for use in subsequent~     studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.~   "
221740|NCT00656357|"~     This study will assess the potential interaction and subjective effects between intravenous~     cocaine and SYN117 in non-treatment seeking cocaine dependant subjects~   "
221831|NCT00655161|"~     This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with~     curative intent who are disease free at their first post-treatment restaging assessment.~   "
241817|NCT00389363|"~     The purpose of the trial is to determine if treatment of asthma patients allergic to house~     dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).~   "
221678|NCT00657163|"~     Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no~     treatment able to enhance recovery has yet been validated. Some drugs may have a positive~     effect when combined with physical rehabilitation. Previous studies have shown a potential~     effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our~     group has demonstrated in a small group of stroke patients (n=8) that a single dose of~     fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and~     modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind,~     randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin~     (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic~     stroke.~   "
221679|NCT00657150|"~     The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral~     dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily.~     Safety and efficacy will be compared between the treatment groups.~   "
221680|NCT00657137|"~     This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with~     placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate~     urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate~     selection criterion for patients who will benefit from future treatment with apricoxib.~   "
221681|NCT00657124|"~     To elucidate the effect of preoperative supplementation of carbohydrate and branched-chain~     amino acids on postoperative insulin resistance in patients undergoing hepatic resection, we~     set a randomized trial.~   "
221682|NCT00657111|"~     The purpose of this study is to test the safety and tolerability of an investigational~     inhaled flu medication, CS-8958. Study participants will include 38 elderly males and~     females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups~     (Groups A, B, C and D) to receive the study drug or placebo (substance containing no~     medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C~     will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be~     reviewed prior to administering a higher dose of treatment. Study procedures will include~     blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay.~     Participants will be involved in study related procedures for up to 6 weeks.~   "
221683|NCT00657098|"~     Angiogenesis inhibitors and EGFR inhibitors not only have anti tumor activity but also modify~     physiological processes. This study evaluates effects on vascular function, endocrine~     function and metabolism. Changes in these parameters will be analysed for predictive value~     for treatment efficacy.~   "
221684|NCT00657085|"~     To observe the qualitative comparison of follicular damage between treatment with the~     LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.~   "
221685|NCT00657072|"~     Damage to the ligaments of the wrist occurs frequently, however, it is not well publicized or~     understood. Our previous and current biomechanical studies have shown that damage to certain~     wrist ligaments is the likely cause of wrist instability and pain. Based on our three~     dimensional models and animations of actual cadaver motions with various ligaments intact or~     sectioned, we have identified several changes in how the carpal bones move and are positioned~     relative to the radius with various levels of instability. Using this information, we have~     developed a mathematical model that can predict in cadaver wrists which groups of ligaments~     have been injured. We started, under IRB approval, a prospective clinical study to evaluate~     the reliability of this mathematical model. During the past 5 years we have studied 13~     patients with suspected wrist ligament injuries who were previously scheduled for surgical~     treatment. CT scans have been performed of the injured wrist and for comparison purposes, the~     contralateral, uninjured wrist. During these 5 years, there were no problems with the conduct~     of the study. During these 5 years the only changes to the original study application were~        -  a) to include a CT scan of the contralateral wrist for comparison purposes~        -  b) a paper handout given to potential subjects~        -  c) to add additional people to the study team.~      The principal investigator, blinded to the results of the CT scan, surgically explores and~     treats these patients in the same manner that he would for any patient with suspected wrist~     ligament injuries. During the surgery, the investigator determines the integrity of the~     various wrist ligaments. The prediction of which ligaments are damaged, based upon the CT~     scan information and mathematical model is compared to the actual surgical findings. The~     importance of this study is to develop a tool that will allow one to rapidly and non~     invasively diagnose wrist instability and initiate treatment before further damage is done.~   "
221686|NCT00657059|"~     A multi-center, randomized, controlled clinical trial to evaluate the short-term and~     long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and~     preserving renal function in patients with IgAN who have pre-treated (and continue to be~     treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.~   "
221687|NCT00657046|"~     In clinical trials in Japan, droxidopa has been shown to be effective in affecting blood~     pressure changes upon orthostatic challenge in patients with autonomic dysfunction, as well~     as reducing the severity and frequency of symptoms of orthostatic hypotension in these~     patients. The efficacy of droxidopa in ameliorating symptoms in patients undergoing dialysis~     has also been demonstrated in the literature and clinical trials conducted in Japan. The~     current study will investigate the clinical efficacy of two different doses of droxidopa in~     patients with intradialytic hypotension over a 4 week treatment period with a placebo~     control. The clinical efficacy will be evaluated by changes in hypotension- related symptoms,~     as well as changes in blood pressure prior to, during and following, HD sessions as compared~     to their pre-treatment baseline values.~   "
221688|NCT00657033|"~     Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in~     males with erectile dysfunction, and their female partners' sexual quality of life.~   "
221689|NCT00657020|"~     A single center, double blind, randomized, placebo controlled, two-treatments, two-period~     crossover study conducted in adult smokers.~   "
221690|NCT00657007|"~     The purpose of thie study is to evaluate the safety, tolerability, immunogenicity,~     pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.~   "
221691|NCT00656994|"~     The purpose of this study is to determine the long-term effects of Ramelteon, once daily~     (QD), on endocrine function values.~   "
221692|NCT00656981|"~     The objectives of this study were to evaluate the efficacy and safety of drospirenone 3~     mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with~     moderate acne vulgaris during 6 treatment cycles~   "
221741|NCT00656344|"~     This study is exploring the use of an intervention designed to treat PTSD in individuals with~     comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military~     service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. The~     exposure component of the protocol will be enhanced with the use of virtual reality in which~     the client will view a virtual environment while describing their trauma.~   "
221693|NCT00656968|"~     Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated~     with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain~     forms of gastric cancer. Curing this infection generally requires that patients take 2 or~     more antibiotic medications and a stomach acid suppressing medication for about two weeks.~     Current treatments do not always cure the infection and a new treatment is being tested in~     this study. The drugs involved in the new 4 drug treatment have been widely used for~     treatment of this infection. It remains unknown what is the best and most cost effective way~     to give them. This study will compare three different ways of using these drugs.~      Subjects must have active Helicobacter pylori infection in order to participate in this~     study.~   "
221694|NCT00656955|"~     Background:~      In Central Europe, mortality rates for kidney cancers are higher and survival rates are lower~     than in the United States and Western Europe overall.~      The Central and Eastern European Renal Cancer Case-Control Study (CEERCC), completed in 2002,~     offers an opportunity to identify determinants that predict 5-year survival among kidney~     cancer patients.~      Objectives:~      To assess disease recurrence and progression among former participants in the CEERCC.~      To investigate the effect of genetics, lifestyle factors, medical conditions, occupation and~     diet on the outcome of kidney cancer patients in Europe.~      Eligibility:~      Former participants or next-of-kin of former participants in the CEERCC study.~      Design:~      Participants or their next-of-kin are interviewed for 60 minutes and are requested permission~     to collect relevant information from their or their family member s hospital and cancer~     registry records....~   "
221695|NCT00656942|"~     The MGH Center for Translational Pain Research is seeking patients with chronic pain for a~     research study. The study is looking at the effect of opioid (narcotic) pain medicines on~     pain sensation, threshold and tolerance.~   "
221696|NCT00656929|"~     Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D~     insufficiency during the winter may cause increased susceptibility to infections,~     particularly viral upper respiratory tract infections (URIs).~      Objective: To determine whether vitamin D supplementation during the winter season prevents~     or decreases URI symptoms in adults.~      Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults.~     Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo~     for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record~     the incidence and severity of URI symptoms~   "
221697|NCT00656916|"~     The goal of this clinical research study is to compare lung function of patients who inhale~     steroids in the early stages of post-transplant constrictive bronchiolitis (PTCB) to patients~     who continue with standard of care.~   "
221698|NCT00656903|"~     This study will use an eye imaging test called high speed indocyanine green angiography~     (HS-ICG), which examines leaky vessels in the eye, to try to find out why individuals respond~     differently to ranibizumab (Lucentis) treatment for wet age-related macular degeneration~     (AMD). The drug was recently approved by the Food and Drug Administration to treat this~     disease, but the response to the treatment varies markedly among individuals.~      People 50 years of age and older with wet AMD and vision that meets the research protocol~     criteria may be eligible for this study. Participants undergo the following procedures:~      Ranibizumab injections in the study eye once a month for 4 months. Additional injections are~     given only if the study eye shows signs of bleeding or leaking fluid. The eye is numbed~     before the injection and the eye area is cleaned with an antiseptic. Antibiotic drops are~     used for 3 days following the injection to prevent infection.~      Clinic visits once a month for 2 years for evaluations to monitor the response to treatment.~     The evaluations may include the following examinations and tests:~        -  Eye examination with dilation, optical coherence tomography and photography: The~          examination measures visual acuity, thickness of your retina (the back of the eye)~          andeye pressure. Bright lights will also be used so that the doctor can see the back of~          your eye. Photographs of the eye may be taken.~        -  Fluorescein angiography to examine the blood vessels in the eye: A dye called~          fluorescein is injected into a vein in the arm. The dye travels through the veins to the~          blood vessels in the eyes. A camera takes pictures of the dye as it flows through the~          blood vessels. This test is done eight times during the study.~        -  Indocyanine green angiography to examine the blood vessels in the eye: The procedure is~          the same as for fluorescein angiography, but it uses a dye called indocyanine green.~          This test is done once a month for the first year of the study and then every 3 months.~   "
221699|NCT00656890|"~     The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen~     in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in~     patients administered MDX-1100.~   "
221700|NCT00656877|"~     The study to determine the if the incidence of Fat Embolism is decreased using Computer~     Assisted technology when performing a Total Knee Arthroplasty.~   "
221701|NCT00656864|"~     Incretin hormones are hormones produced by the gut in response to food intake. These hormones~     help the body to control the metabolism of glucose (sugar). In particular, two incretin~     hormones (GLP-1 and GIP) cause the pancreas to secrete more insulin in response to high blood~     glucose levels. This helps the body to metabolize the glucose more effectively, lowering~     blood sugar levels. GLP-1 and GIP do not work as well in patients with type 2 diabetes (T2DM)~     as in subjects who do not have diabetes. This study tests whether a medicine called~     pioglitazone (Actos), which is commonly used to treat T2DM, improves the ability of GIP to~     increase insulin secretion.~      To address this question the investigators will recruit patients with T2DM whose diabetes is~     controlled with either diet and exercise or with metformin (another medicine commonly used to~     treat T2DM). Subjects will undergo measurement of body fat by DEXA scanning and a series of~     studies to characterize their metabolism. These studies include an oral glucose tolerance~     test (a test sometimes used to diagnose diabetes), a mixed-meal challenge (to measure how~     much GLP-1 and GIP are produced in response to a meal) and measurement of insulin secretion~     in response to glucose and GIP given through a vein. The investigators will also obtain small~     samples of fat (from just under the skin of the belly) using a needle to measure levels of~     the receptor for GIP. Subjects will then be randomly assigned to 12 weeks of treatment with~     either pioglitazone or matching placebo (an inactive tablet that does not contain~     medication). The dose of pioglitazone will be increased during the first 4 weeks to the~     maximum prescribed dose of 45 mg per day. Subjects will be seen every 2-4 weeks during the~     treatment phase of the study. After 12 weeks of treatment all studies performed at the~     beginning of the study will be repeated. The pioglitazone treatment will continue until the~     end of testing, approximately 4 weeks.~      The results of this study may give us information about why glucose control deteriorates in~     T2DM. This information might also lead to new ways to prevent or treat T2DM.~   "
221702|NCT00656851|"~     We hypothesize that the hearts of HIV+ people with The Metabolic Syndrome use and oxidize~     fats and sugars inappropriately, and that this may impair the heart's ability to pump blood.~     We hypothesize that exercise training or pioglitazone (Actos) will improve fat and sugar~     metabolism in the hearts of HIV+ people with The Metabolic Syndrome. This study will advance~     our understanding of cardiovascular disease in HIV+ people, and will test the efficacy of~     exercise training and pioglitazone for improving insulin resistance, heart metabolism and~     heart function in this at risk population.~   "
221742|NCT00656331|"~     The purpose of this study is to compare the effects of the cholesterol medication taken with~     each blood pressure medication alone on heart disease risk factors including blood pressure,~     cholesterol, inflammation, blood sugar control, blood vessal function, and other heart~     disease risk factors.~   "
226190|NCT00597168|"~     This is a non-interventional study evaluating quality of life in schizophrenic patients~     treated with atypical antipsychotics, in the ambulatory setting. This is a 9-month,~     observational, multicentric prospective study.~   "
221703|NCT00656838|"~     FIBER is 4-year study that will evaluate the implementation of a large-scale population-based~     colorectal cancer screening patient reminder and coordinated follow-up program. The CRC~     screening program began in 2007 with Kaiser Permanente Northwest (KPNW),a not-for- profit,~     integrated health system in Oregon and Washington. FIBER consists of 1)a practical randomized~     controlled trial at the start of the program, followed by 2) a longer-term cohort study as~     all remaining eligible patients receive the program, and 3)a qualitative evaluation. FIBER~     will evaluate the factors that are associated with implementation success across multiple~     levels: patient, primary care provider (PCP) team, specialists (gastroenterologists, general~     surgeons, pathologists), and other health plan staff and systems.~   "
221704|NCT00656825|"~     Transforming growth factor-beta 1 (TGF-β1) is consistently over expressed in most fibrotic~     diseases and displays a variety of profibrotic effects in fibroblasts. Activation of TGF-β~     receptors induces the activation of several kinase signalling cascades leading to the~     phosphorylation of SMAD proteins as well as to the activation of SMAD-independent kinases~     that collectively activate ECM synthesis and fibroblast growth and differentiation into~     myofibroblasts. TGF-β1 is one of the main mediators in the fibrotic process, associated to~     both scarring and a long list of pathologies related to chronic inflammation and which affect~     all type of organs and tissues. An increase in TGF-β1 mRNA and protein levels has been~     described in these processes. Peptide 144 (P144) is the acetic salt of a 14mer peptide from~     human TGF-β1 type III receptor (betaglycan). P144 TGF-β1-inhibitor has been specifically~     designed to block the interaction between TGF-β1 and TGF-β1 type III receptor, thus blocking~     its biological effects. P144 has shown significant antifibrotic activity in mice receiving~     repeated subcutaneous injections of bleomycin, a widely accepted animal model of human~     scleroderma, and could contribute to the development. The purpose of this study is to assess~     the tolerability and safety of topical application of P144 in healthy volunteers.~   "
221705|NCT00656812|"~     The purpose of this trial is to evaluate whether a Rituximab plus 2 CdA combination therapy~     is effective and safe in the treatment of patients with advanced or relapsed lymphoma of the~     mucosa associated lymphoid tissue (MALT).~   "
221706|NCT00656799|"~     The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium~     complex; it's safety and efficacy in participants with severe renal impairment.~   "
221707|NCT00656786|"~     This is a clinical research study of an experimental new medication, Menadione Topical Lotion~     (MTL). The study lotion is experimental and has not been approved for public use. Hana~     Biosciences, Inc., the company that is developing MTL, is the sponsor of this study. EGFR~     inhibitors are used to treat non-small cell lung cancer (NSCLC), pancreatic cancer,~     colorectal cancer, breast cancer and head and neck cancer. One of the side effects of EFGR~     inhibitors is skin toxicities including an acneform skin rash.~      This study is a Phase 1 study. The main purposes of this study are:~        -  Evaluate the safety and tolerability of Menadione Topical Lotion as an emergent and~          pre-emergent treatment for EGFR inhibitor-associated rash~        -  Evaluate the systemic absorption and bioavailability of Menadione Topical Lotion as an~          emergent and pre-emergent treatment for EGFR inhibitor-associated rash~      It is planned that up to 24 patients undergoing EGFR inhibitor therapy will take part in this~     study at multiple clinical centers.~   "
221708|NCT00656773|"~     Obtaining high-quality analgesia in prehospital patients with severe pain is an important~     treatment objective for medical team. Opioids are recognized as the treatment of choice for~     relief of severe acute pain. Recommended initial analgesia of patients with severe acute~     pain, defined as a visual analog scale or a numerical rating scale (NRS) score of 60/100 or~     higher, in a prehospital setting in France consists of the administration of opioids by the~     medical staff of mobile intensive care units. The intravenous administration of morphine is~     usually considered as the gold standard for postoperative acute pain relief because of its~     rapid transport from the blood to target tissues after intravenous injection, its~     long-lasting analgesic effect without any plateau, and its well-known pharmacokinetics.~     Nevertheless, the short-acting opioid sufentanil might be preferable to the traditional~     long-acting morphine for prehospital analgesia because of its even faster onset of action and~     shorter duration than morphine. There is no study, to our knowledge, comparing the clinical~     efficacy of sufentanil vs morphine in a prehospital setting. This randomized double-blind~     group clinical trial is designed to determine the best intravenous opioid titration protocol~     by comparing sufentanil and morphine for medical prehospital treatment of adult patients with~     severe acute pain. Eligible patients with a numerical rating scale (NRS) score of 60/100 or~     higher will be randomly allocated to receive either 0.15 µg/kg sufentanil then 0.075 µg/kg~     every 3 minutes (group A) or 0.15 mg/kg morphine then 0.075 mg/kg every 3 minutes (group B)~     intravenously. The decision to provide opioid analgesia including titration of subsequent~     doses of narcotic is the responsibility of physicians and intravenous analgesia will be given~     and titrated according to the pain score every 3 minutes. The drugs will be administered by~     the physician from syringes of similar appearance prepared by the nurse who is not otherwise~     involved in the study. The protocol-defined primary outcome measure is the percentage of~     patients with pain relief (with a NRS score of 30/100 or lower) 15 minutes after the first~     injection. Secondary outcomes include pain score comparisons every 3 minutes within the first~     30 minutes and comparison of adverse events. The physician blinded to the analgesic treatment~     groups will do all assessments of patients. The safety evaluation will include non invasive~     monitoring of blood pressure, heart rate, respiratory rate, oxygen saturation by pulse~     oximetry (Spo2), and a sedation scale (0, patient is awake; 1, patient is with intermittent~     sleeping; 2, patient is sleeping, awakened by verbal stimulation; 3, patient is sleeping,~     awakened by tactile stimulation; 4, patient is not aroused by stimulation) at these periods.~     Fifteen minutes after the first injection, overall patient and investigator satisfaction with~     analgesia was recorded.~   "
221709|NCT00656760|"~     Historically metastatic squamous cell carcinoma in a cervical lymph node from an occult~     primary malignancy of the head and neck was evaluated with panendoscopy and biopsies of high~     risk areas, such as the base of tongue, nasopharynx, and tonsils. This diagnostic protocol~     identifies the primary malignancy in about 50% of cases. In recent years, the availability of~     CT has slightly increased the detection rate to 65% when used as an adjunct to the~     traditional work-up. Studies using PET as an adjunct are conflicting with detection rates~     ranging up to 75%. Currently, no prospective study has analyzed the role of the PET-CT fusion~     in the work-up of an occult primary malignancy of the head and neck. This study will compare~     the detection rate of the traditional work-up to a new protocol involving a pre-operative~     diagnostic PET-CT.~   "
221710|NCT00656747|"~     A study to assess the safety and efficacy of moxifloxacin compared to that of~     amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic~     bronchitis.~   "
221711|NCT00656734|"~     To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear~     cell renal cell carcinoma (Kidney cancer).~   "
221712|NCT00656721|"~     Considering that respiratory physiotherapy lack scientific evidence to support its~     application in the treatment of several obstructive diseases, this investigation was designed~     to evaluate the hypothesis that Flutter Valve can improve the airway clearance of~     hypersecretive bronchiectasis patients.~   "
221936|NCT00653796|"~     This study was designed to assess whether co-administration of ezetimibe 10 mg with~     atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with~     atorvastatin 10 mg alone for reducing LDL-concentrations.~   "
221714|NCT00656695|"~     Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more~     than 2500 new renal transplantation each year and because of this the government pay a huge~     amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an~     Iranian drug company introduced this drug in the name of Iminoral which has been approved by~     different authorities in Iran and abroad, (including the Ministry of Health in Iran and also~     European Directorate for the Quality of Medicines Certification Unit and FDA(Department of~     Health and Human Services,Center for Drug Evaluation and Research)). The investigators study~     is the first clinical trial to compare the effect of Iminoral versus Neoral in preventing~     acute rejection in renal transplantation and also to compare the side effects of these two~     drugs.~   "
221715|NCT00656682|"~     The purpose of this study is to determine if providing free-of-charge access to a group-based~     lifestyle intervention delivered in partnership with the community is cost-effective for the~     prevention of type 2 diabetes.~   "
221716|NCT00656669|"~     The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant~     (given before surgery) treatment for patients that have either inoperable or operable breast~     cancer. This treatment can help shrink the tumors so they can be removed to help prevent the~     cancer from spreading to other parts of the body. This study is being done to test the impact~     of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel~     (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition~     of sunitinib will make the treatment more effective, but we don't know if this is true.~   "
221717|NCT00656656|"~     Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies~     against certain proteins important for maintaining skin integrity. Protein A immunoadsorption~     is a dialysis-like technique selectively removing the antibodies from patient's blood.~     Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for~     production of antibodies in the patients blood that, in turn, lead to clinical signs of~     pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that~     may be used to suppress autoantibody production in pemphigus. While each of these three~     therapies had been used to treat pemphigus, none was shown effective in all cases. The~     hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and~     dexamethasone is more effective that either of these treatments alone in achieving a rapid~     and durable improvement or cure in patients with pemphigus.~   "
221718|NCT00656643|"~     The purpose of this study is to determine the safety and efficacy of an ocular sirolimus~     (rapamycin) formulation at various doses in patients with diabetic macular edema.~   "
221719|NCT00656630|"~     The purpose of this study is to develop and validate a human laboratory model for prediction~     of medication efficacy in clinical trials for relapse prevention in alcohol dependence.~   "
221720|NCT00656617|"~     The goal of this clinical research study is to find the highest safe dose of vorinostat that~     can be given in combination with idarubicin and ara-C for the treatment of AML and high-risk~     MDS.~      Once the highest safe dose is found, researchers will then try to learn if this combination~     treatment can help to control AML and high-risk MDS in newly diagnosed patients. The safety~     of this treatment combination will also be studied.~   "
221721|NCT00656604|"~     RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance~     imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help~     doctors find and diagnose breast cancer and plan the best treatment.~      PURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics~     analysis to see how well they work in evaluating healthy women and women who are undergoing~     surgery for breast cancer.~   "
221722|NCT00656591|"~     An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for~     Pregnant Women in Nepal to Reduce Fetal & Infant Mortality and to Improve Fetal Growth &~     Cognitive Development in Infancy~   "
221723|NCT00656578|"~     The primary purpose of this study is to compare the analgesic efficacy of a single~     intraoperative administration of 4975 vs. Placebo in the management of acute postoperative~     pain in patients undergoing bunionectomy.~      Secondary objective of this study is to evaluate the safety and tolerability of a single~     intraoperative administration of 4975.~   "
221724|NCT00656565|"~     Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory~     flow rates and volumes. These vary according to the device being used and its resistance. The~     dry powder inhaler device under investigation is a device approved by the Therapeutic Goods~     Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is~     currently being investigated as a treatment for bronchiectasis. We wish to measure the~     inspiratory flow characteristics of both the low and high resistance devices amongst a group~     of subjects with bronchiectasis.~      We propose that the majority of subjects investigated with varying lung function will achieve~     adequate flow during a controlled inspiration.~   "
221725|NCT00656552|"~     Escitalopram has been claimed to have the highest selectivity for the human serotonin~     transporter relative to the noradrenaline or dopamine transporters. This might be associated~     with greater clinical efficacy. Most adverse events reported by escitalopram-treated patients~     are mild and transient.~      In this study, we compare escitalopram with placebo in the treatment of PE.~   "
221726|NCT00656539|"~     The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic~     solution, 1% on signs and symptoms of blepharitis.~   "
221727|NCT00656526|"~     To relieve post laminectomy pain, we have tried intraoperative perineural injection of~     lidocaine right after the exposure in expecting that this would be preemptive analgesia by~     blocking the nerve transmission so that postoperative pain starts later and lighter.~   "
221728|NCT00656513|"~     RATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and~     pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which~     remedy is more effective in treating chronic dry mouth caused by radiation therapy in~     patients with head and neck cancer.~      PURPOSE: This randomized phase II/III trial is studying ALTENS to see how well it works~     compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in~     patients with head and neck cancer.~   "
221937|NCT00653783|"~     The overall goal of PROBE is to evaluate the feasibility and potential utility of three~     markers (alpha-synuclein, transcriptomic profiles and olfactory function) to determine the~     risk or prognosis of PD.~   "
221729|NCT00656500|"~     Elective surgery represents a teachable moment to deliver tobacco interventions. The overall~     goal of this proposal is to increase the utilization of the QUITPLANSM Helpline by surgical~     patients who smoke. Two specific aims will be pursued using a multidisciplinary research~     team. In the first aim, we will develop a practice-based intervention to promote QUITPLANSM~     Helpline utilization by surgical patients (Specific Aim 1A) using a combination of key~     informant interviews (approximately 30 subjects), and focus groups (approximately 25~     subjects) then develop methods to educate providers in its implementation (Specific Aim 1B)~     and test their effectiveness in approximately 20 providers. In the second aim, we will~     perform a randomized clinical trial of this intervention in 300 patients scheduled for~     elective surgery, with the primary outcome being utilization of the QUITPLANSM Helpline~     (Specific Aim 2). Subjects will be randomized to receive either the intervention developed in~     Specific Aim 1, or a brief control intervention.~   "
221730|NCT00656487|"~     The purpose of this study is to find out more about cognitive functioning in people who are~     cannabis dependent, relative to people who do not use cannabis, and how their brains process~     information after one month of not using cannabis. An additional goal is to characterize the~     severity of cannabis dependence using precipitated and naturalistic withdrawal with a double~     blind, placebo controlled, single administration of rimonabant. Research assessments occur~     bi-weekly throughout this 28 day study.~   "
221731|NCT00656474|"~     Study is intended to evaluate safety and efficacy parameters in patients treated with~     GLYC-101 gel or placebo after laser ablation.~   "
221732|NCT00656461|"~     This is an open-label study to determine the highest dose of MKC-1 that may be administered~     daily on a continuous basis for patients with advanced or refractory solid tumors.~   "
221733|NCT00656448|"~     The goal of this clinical research study is to find out if Procrit (epoetin alfa) will help~     decrease the need for blood transfusions in patients who have Acute Myelogenous Leukemia~     (AML) or High-risk Myelodysplastic Syndrome (MDS) and are receiving chemotherapy. Researchers~     also want to learn about the remission rates (rates of recovery) in patients with cancer who~     have received treatment with epoetin alfa. The safety and effectiveness of this therapy will~     also be studied.~   "
221734|NCT00656435|"~     Persistent or recurrent vitreous hemorrhage after vitrectomy for diabetic retinopathy~     complications is a common occurrence with an incidence of 12% to 63%. This complication may~     prolong vitreous clear-up and delay visual rehabilitation significantly, and sometimes~     requires additional procedures or surgery.~      The causes of bleeding are diverse. Evidence suggests fibrovascular proliferation from the~     sclerotomy sites or from the vitreous base may be an important source of recurrent vitreous~     hemorrhage; other sources of bleeding include iatrogenic intraoperative injury of retinal~     vessels, and incomplete removal of fibrovascular tissues.~      We have reported on the possible benefit of peripheral retinal cryotherapy and cryotherapy~     treatment of sclerotomy sites to prevent delayed-onset recurrent vitreous hemorrhage, and the~     possible benefit of intravitreal long-acting gas to reduce the occurrence of early~     postoperative recurrent vitreous hemorrhage, especially for cases with active fibrovascular~     proliferation. However, minor recurrent vitreous hemorrhage and prolonged reabsorption of~     lysed blood clots from surgical trauma remain important factors to cause media opacity long~     enough to prevent quick visual rehabilitation.~      Intravitreal bevacizumab has been noted to induce rapid regression of retinal and iris~     neovascularization in proliferative diabetic retinopathy. Further, presurgical administration~     of intravitreal bevacizumab may reduce intraoperative bleeding during membrane dissection in~     PDR with traction retinal detachment. We hypothesize that presurgical treatment of~     intravitreal bevacizumab may reduce intraoperative bleeding and the amount of residual blood~     clots, while intraoperative infusion of long-acting gas may facilitate post-operative~     recovery of surgically injured retinal vessels. These combined effects would thus enhance~     early clear-up of vitreous opacity from clot lysis and recurrent retinal bleeding. To~     investigate this hypothesis, a clinical prospective study was undertaken to evaluate the~     effects of bevacizumab pretreatment combined with intravitreal infusion of long-acting gas on~     the clearance speed and the recurrence rate of early postoperative vitreous hemorrhage in~     vitrectomy for active diabetic fibrovascular proliferation.~   "
221735|NCT00656422|"~     The main objective of this clinical trial is to investigate hepatic fat as the primary~     endpoint along with body fat, and weight changes after initiation of a basal insulin therapy~     together with data acquisition that is today's standard in studies investigating obesity and~     eating patterns with insulin detemir and insulin glargine.~   "
221736|NCT00656409|"~     Ataxia Telangiectasia (AT) is an autosomal recessive inherited condition caused by mutations~     in the ATM gene1. Patients suffer from neuro-degenerative problems, usually commencing in the~     second year of life, and affecting predominantly the cerebellum. They also develop the~     characteristic superficial telangiectases. Between 60 and 80% of affected children are~     immunodeficient. This is associated with deficiency of immunoglobulin A (IgA ) 2, of IgG23~     and of antibody responses to pneumococcal polysaccharides4. Patients suffer recurrent~     sino-pulmonary infections but a recent study suggests poor correlation between immune status~     and immunological parameters5. If uncontrolled, recurrent pulmonary infections can contribute~     to the development of chronic lung disease and bronchiectasis. Preventative management~     includes continuous prophylactic antibiotic treatment in some with the need for replacement~     immunoglobulin therapy in only a small proportion of cases. Antibiotics have been reasonably~     effective in this situation but the emergence of resistance amongst community acquired~     pneumococcal isolates is a cause for concern. Appropriate immunisation strategies may also~     have a role.~      This study is designed to look at antibody responses in a one versus two dose regimen in a~     cohort of AT patients recruited through the AT Society a national charitable organisation~     involved in providing support to families with this condition and in fostering education and~     research in the field.~   "
221737|NCT00656396|"~     Bleeding is a frequent complication during surgery. The peri-operative administration of~     blood products, including packed red blood cells, thrombocytes and fresh frozen plasma (FFP),~     is often deemed necessary. Therefore the transfusion of allogenic blood products mandates~     strategies to optimize the clinical decision to transfuse. The decision to administer FFP is~     usually made in the absence of any data. Point of care testing of prothrombin time ensures~     that a major parameter of coagulation is readily available. The test is fast, easy to~     perform, inexpensive and may enable physicians to rationally determine the need for FFP.~     Objective of the study is to determine the effectiveness of point of care coagulation testing~     of prothrombin time to reduce the administration of FFP.~   "
221738|NCT00656383|"~     Individuals referred to home care for leg ulcer management were randomized to nurse home~     visits (usual care) or nurse-run community clinics (intervention). The primary outcome will~     be the time to healing rates at three months. Secondary outcomes are: time to healing of all~     ulcers within the 12 month follow-up period, time to first recurrence of a healed ulcer, the~     number of weeks patients were free from ulcers, function, pain, and health related quality of~     life, client and provider satisfaction. We hypothesize that nurse-run neighborhood clinics~     result in better healing rates, more cost-effective care, and improved client and provider~     satisfaction than the home visiting model.~   "
221964|NCT00653432|"~     The purpose of this study is to determine whether intra-articular hyaluronic acid provides~     symptomatic relief of osteoarthritis of the knee.~   "
221743|NCT00656318|"~     Thus, the proposed study has the following Specific Aims and Hypotheses:~        1. To determine in menstruating women ages 18-45 whether an OCP containing ethinyl~          estradiol (EE) and the progestin ethinydiol diacetate (ED) increases cortical GABA~          concentrations as measured using proton magnetic resonance spectroscopy (1H-MRS) above~          that of an OCP containing EE and the progestin norethindrone (NOR).~        2. To determine the relationship between changes in occipital GABA concentrations with~          acute OCP administration and negative affect with chronic OCP administration over two~          menstrual cycles.~   "
221744|NCT00656305|"~     A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic~     Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not~     Candidates for Radiation Therapy~   "
221745|NCT00656292|"~     The purpose of the present study is to quantify the degree of modulation, if any, in the~     perioperative inflammatory response associated with statins use. Specifically, we hypothesize~     that:~      In a population of patients undergoing elective orthopedic spine surgery, administration of a~     specific statin (Simvastatin, Zocor®, Merck Pharmaceuticals), will be associated with a~     decrease in perioperative inflammatory markers when compared to patients not taking statins~   "
221746|NCT00656279|"~     A low phosphorus diet is recommended for patients with chronic kidney disease who exhibit~     high levels of phosphorus. The purpose of this study is to determine the effects of a more~     intensive, innovative dietary phosphorus educational intervention on reducing serum~     phosphorus levels, as well as improving dietary adherence, dietary satisfaction and~     phosphorus knowledge level in patients with chronic kidney disease.~   "
221747|NCT00656266|"~     The objective of this study is to compare the effects of two liver transplant~     immunosuppression regimens on renal function. Patients receiving the standard combination of~     prednisone and high-dose tacrolimus, a drug with known nephrotoxicity (Arm A) will be~     compared to patients receiving prednisone, low-dose tacrolimus and mycophenolate mofetil~     (MMF) (Arm B). MMF is an immunosuppression agent that has no associated nephrotoxicity. The~     primary end point of the study will be renal function as measured by glomerular filtration~     rate (GFR). Thirty pediatric liver transplant recipients will be randomized to these two arms~     in a 1:1 ratio (i.e. 15 patients in each group). Secondary end points will measure patient~     and graft outcome and incidence of immunosuppression-related complications, including:~     neurotoxicity, diabetes mellitus, growth retardation, vomiting, diarrhea, gastrointestinal~     hemorrhage, thrombocytopenia, anemia, leukopenia, acute or chronic liver graft rejection,~     posttransplant lymphoproliferative disease (PTLD), viral infections, fungal infections and~     bacterial infections.~   "
221748|NCT00656253|"~     This study was designed to evaluate the symptomatic effects or potential disease progression~     slowing down effect of a kind of Herbal Medicinal Mixture in Parkinson's disease (PD)~     patients. The treatment phase includes 12 months period of Herbal Medicinal Mixture per day~     or placebo and 1 month wash-out period without herbal medicine and placebo.~   "
221749|NCT00656240|"~     To investigate the intraocular pressure (IOP)-lowering effect and safety of DE-104 ophthalmic~     solution in patients with Primary Open-Angle Glaucoma or Ocular Hypertension~   "
221750|NCT00656227|"~     This trial will investigate whether four doses of RN1001 (20ng, 50ng, 100ng and 200ng) are~     efficacious in preventing or reducing the resultant scar, as compared to placebo, when~     applied intradermally to wound margins following excision of benign naevi situated on the~     head and neck.~   "
221751|NCT00656214|"~     the purpose of this study was to evaluate that if lycopene, a potent antioxidant can be used~     in the treatment of oral lichen planus. this could be useful as lycopene has no reported side~     effects and hence it can used in place of steroids which are commonly used for this condition~     and have many reported adverse effects.~      lycopene can be used in the treatment of this condition as free radicals have been found to~     play a role in the cause of this disease and also lower levels of lycopene were seen in these~     patints.~   "
221752|NCT00656201|"~     The goal of this research study is to compare the pregnancy rates for two different types of~     progesterone supplementation after in-vitro fertilization (IVF).~   "
221753|NCT00656188|"~     This study tested the hypothesis that vardenafil was both clinically effective and~     well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.~   "
221754|NCT00656175|"~     Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of~     people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are~     closely associated with these regimens. Therefore, there is a need for a drug with comparable~     effectiveness to the ritonavir boosted PIs without the side effects of dyslipidemia, which~     has been associated with elevated cholesterol and cardiovascular disease~      Raltegravir is an HIV integrase inhibitor in phase III clinical development. To date there~     are no approved drugs that target the same stage of the HIV-1 lifecycle. However, data from~     studies indicate that raltegravir is generally safe and well tolerated and has strong~     antiretroviral activity when used in combination with licensed antiretroviral medications.~      This study aims to demonstrate that patients substituting raltegravir for a PI or NNRTI based~     antiretroviral regimen will be associated with a 10% reduction in body fat over 24 weeks.~      The study will consist of a total of 10 subject visits over a period of 48 weeks.~     Approximately 40 female patients will participate in this study (approximately 10 at UCLA).~   "
221755|NCT00656162|"~     Fractures of an elbow are common in children. Accurate initial diagnosis is crucial for the~     management of the fractures of an elbow. In young children the fractures may be suspected~     clinically but missed on x-rays due to mostly non-ossified cartilage that is not visible on a~     regular x-ray. We propose that every x-ray negative, but clinically suspicious elbow trauma~     in children can be additionally evaluated using high resolution US.~   "
221779|NCT00655850|"~     This study is being done to determine the overall progression-free survival (PFS) in patients~     with advanced or metastatic (Stage IIIB - pleural effusion/IV), non-squamous histology NSCLC~     treated with metronomic chemotherapy plus Avastin. Also, currently there are no defined~     markers that predict for clinical benefit to Avastin. Preliminary studies show that there are~     several observations that support the concept of metronomic chemotherapy with or without the~     combination of an anti-angiogenic agent. The metronomic chemotherapy with Avastin was shown~     to enhance the clinical endpoints of the study (response rate and progressive-free survival).~     Proof of metronomic scheduling requires the development of appropriate intermediate surrogate~     markers. Several markers will be assessed.~   "
221756|NCT00656149|"~     1. To evaluate improvements in hand function in stable, cervical spinal cord injured (SCI)~          subjects treated with functional electrical stimulation (FES)-assisted exercise;~        2. To compare the information obtained from existing qualitative and quantitative hand~          function tests with newly developed tests of sensorimotor performance.~      Hypotheses:~        1. the performance of tasks representative of activities of daily living (ADL) will improve~          with daily tele-supervised exercise of the affected hand.~        2. The improvements will be greater in one exercise protocol than the other, the protocols~          being a) FES-assisted exercise on a workstation, b) cyclical FES, weight training and~          precision tasks.~        3. Scores derived from quantitative data obtained from sensors on the workstation will~          correlate with the qualitative scores of the primary outcome measure, the ARAT hand~          function test.~   "
221757|NCT00656136|"~     This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients~     with NSCLC who have received previous treatment with at least one but not more than two lines~     of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either~     gefitinib or erlotinib for a period of at least 12 weeks and then progressed.~      The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a~     single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population.~     Patients on both treatment arms will receive best supportive care in addition to study~     treatment.~      Patients enrolled into the trial will be treated and followed until death or lost to~     follow-up.~   "
221758|NCT00656123|"~     RATIONALE: Vaccines made from tumor cells may help the body build an effective immune~     response to kill tumor cells. Giving vaccine therapy together with chemotherapy may be a more~     effective treatment for colorectal cancer.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy given together~     with cyclophosphamide in treating patients who have undergone surgery for liver metastases~     due to metastatic colorectal cancer.~   "
221759|NCT00656110|"~     The purpose of this study is to determine whether, in a randomized, placebo-controlled trial,~     restless legs syndrome (RLS) can be caused by pinched and damaged foot nerves called~     neuromas.~   "
221760|NCT00656097|"~     The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in~     combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo~     in combination with rabies vaccine in healthy adult subjects.~   "
221761|NCT00656084|"~     To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone,~     and Rituxan in relapsed or refractory MCL~   "
221762|NCT00656071|"~     By examining the intraoperative anesthetic characteristics of patients who developed ARDS~     postoperatively, we hope to identify variables which have a positive or negative association~     on the development of ARDS.~   "
221763|NCT00656058|"~     Background:~      Bronchiolitis obliterans is a form of chronic graft-versus-host disease (GVHD) that sometimes~     develops after stem cell transplantation (SCT) or bone marrow transplantation (BMT).~      In bronchiolitis obliterans, immune cells that normally fight infections attack the lungs of~     the transplant recipient, causing destruction of lung tissue and fibrosis (scarring). When~     fibrosis develops, the lungs cannot work properly.~      Montelukast (Singulair) is a drug that has been used for many years to treat asthma. Its use~     as a treatment for bronchiolitis obliterans is experimental.~      Objectives:~      To see if montelukast improves or stabilizes lung function in patients who develop~     bronchiolitis obliterans after BMT or SCT.~      To assess the safety of montelukast in patients with bronchiolitis obliterans after BMT or~     SCT~      To see if montelukast affects the cells that damage the lungs.~      To see if montelukast improves other forms of chronic GVHD, quality of life, and overall~     survival in patients with bronchiolitis obliterans after BMT or SCT.~      Eligibility:~      Patients 6 years of age and older with bronchiolitis obliterans following stem cell~     transplantation.~      Design:~      Patients take one montelukast tablet daily for 6 months and undergo the following procedures~     during this period:~        -  Lung function tests. The patient breathes into a machine that measures the amount of air~          that goes into and out of the lungs. This test is done once a month for 3 months, then~          at 6 months, 12 months and 24 months.~        -  Medical history and physical examination at the study site about every 3 months for the~          first year of the study and then at 12 months and 24 months. Patients also have physical~          examinations monthly for the first 6 months at their primary doctors office. Tests may~          include blood and urine tests, chest computed tomography (CT) scans, echocardiogram~          (heart ultrasound), 2- and 6-minute walk tests, and quality-of-life questionnaires.~        -  Bronchoalveolar lavage in patients 18 years of age and older. The subject s mouth, nose~          and airways are numbed with lidocaine. Some patients may need sedation or anesthesia for~          the procedure. A tube (bronchoscope) is then passed through the nose into the airway,~          and a small amount of fluid is put into the lung. The fluid is then removed and tested~          for infections or other lung problems.~        -  Apheresis to collect white blood cells. Whole blood is collected through a tube inserted~          into a vein in the arm. The white cells are extracted in a cell separator machine, and~          the rest of the blood is returned to the body through a tube placed in a vein in the~          other arm. The cells are used to study GVHD and bronchiolitis obliterans.~        -  Patients who wish to continue montelukast therapy after 6 months may do so under the~          care of their primary doctor, if both agree to the continuation....~   "
221764|NCT00656045|"~     The purpose of this investigation is to conduct an 8-week pilot study to examine the effects~     of two different leisure-time activity prescriptions on dietary intake, leisure-time~     activities, and weight loss in 26 adults receiving a standard 8-week behavioral weight loss~     intervention.~   "
221765|NCT00656032|"~     The broad goal of this study is to understand the mechanisms by which Vitamin D receptor~     activation leads to changes in insulin signaling in advanced uremia. We hypothesize that~     1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin~     resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in~     End Stage Renal Disease patients.~   "
221766|NCT00656019|"~     This study will assess whether levels of vitamin D impact the characteristics of a woman's~     breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels~     of vitamin D changes the gene expression of their breast cancers.~   "
221767|NCT00656006|"~     A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis~     C Genotype 2 or 3.~   "
221768|NCT00655993|"~     Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in~     COPD patients.~   "
221769|NCT00655980|"~     In this study, we want to find out if laughing gas (nitrous oxide) leads to a higher rate of~     cardiac complications after surgery in patients with a specific genetic profile (mutations in~     the MTHFR gene) and if this risk can be prevented by giving patients vitamin B12 and folate~     during surgery.~   "
221780|NCT00655837|"~     The purpose of this study is to determine safety and tolerability of combination therapy of~     SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also~     intended to estimate how well your disease responds to this treatment.~   "
221781|NCT00655824|"~     A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and~     who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the~     trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9~     treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo~     in Trial Hx-CD20-403.~   "
221770|NCT00655967|"~     Alcohol abuse and dependence are very prevalent and result in significant morbidity,~     mortality and cost to society (Harwood 2000). Pharmacotherapies to assist with alcohol~     dependence consist of disulfiram, naltrexone and acamprosate. Of these, acamprosate is unique~     in that it is not metabolized by the liver, but rather completely excreted renally. In~     contrast, naltrexone is metabolized by the CYP450 system of the liver and less than 2% is~     excreted unchanged and can cause liver damage (PDR 2005). Multiple cases of hepatitis,~     including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in~     transplantation or death, have been reported with administration of disulfiram (PDR 2005).~     The incidence of liver disease among alcoholics is high and increases with age and years of~     drinking and this may preclude the use of antabuse or naltrexone to help alcohol dependent~     patients with liver disease or that are elderly . Thus acamprosate has a unique safety~     profile that would make it ideally suited for treating alcohol dependence in the elderly,~     even in the presence of hepatic impairment. The current study is to evaluate the safety~     profile of acamprosate in elderly patients with alcohol dependence.~      Acamprosate, calcium acetyl homotaurinate, has been approved in most European countries and~     the U.S. for the maintenance of abstinence in recently detoxified alcoholics. The mechanism~     of action involves primarily the restoration of a normal N-methyl- D -aspartate (NMDA)~     receptor tone in glutamatergic systems (Rammes et al 2001). Several trials of acamprosate~     confirm its efficacy in the maintenance of abstinence in alcohol dependence (Lesch et al.~     2001; Slattery et al. 2003; Mann et al. 2004; Verheul et al. 2004). It also reduces the~     severity of relapse in alcoholics in abstinence based treatment programs (Chick et al. 2003).~     There is limited data on the safety of acamprosate in the elderly (PDR 2005).~      For the purposes of this study, elderly will be defined as 60 years or older.~      STUDY OBJECTIVE: To determine the short-term safety of Acamprosate in the treatment of~     alcohol dependence in the elderly.~   "
221771|NCT00655954|"~     -  Osteoprotegerin (OPG) is a secreted glycoprotein containing 401 amino acids. It is a~          member of the tumour necrosis factor (TNF) receptor superfamily. It was firstly~          discovered as a protein regulating bone metabolism, inhibiting osteoclastogenesis,~          consequently, inhibiting bone resorption~        -  Evaluation of OPG level as disease markers has also been reported. It has been showed~          that patients with coronary artery disease had higher serum OPG levels than healthy~          volunteers. Moreover, serum OPG levels correlate with the number of stenotic coronary~          arteries~        -  OPG is detected in lung using Northern blot analysis~        -  It is likely that OPG would contribute to the pathogenesis of COPD and could be an~          effective disease marker of the disease~   "
221772|NCT00655941|"~     Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.~      The two diseases intertwine in several ways. The evolution in the population shows a tendency~     towards deterioration of both by increasing general age and weight. The two diseases share~     pathogenetic features and the development of one disease increases the risk of the other and~     may be the onset of a vicious circle.~      There is a link between treatments of these two diseases as well. There is now solid (gold)~     evidence that by treating effectively the obesity of patients with co-occurring OA, the~     functional status is dramatically ameliorated; the short-term results are equal to that of a~     joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is~     definitely one of many diseases in which obesity must be taken seriously into account when~     planning a correct treatment of patients. This trial has two phases, the first (16 weeks)~     consisting of a dietary intervention with low-energy diet and the second (52 weeks) a~     randomized, three group (each n>50 patients) controlled study of maintenance of weight loss~     by either continuing dietary instruction, exercise, or a control group. The hypothesis is~     that maintenance of an initially induced weight loss is dependent on attention rather than~     any specific therapy.~   "
221773|NCT00655928|"~     The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day~     pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on~     blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.~   "
221774|NCT00655915|"~     This study will investigate whether symptomatic improvement following carpal tunnel~     corticosteroid injection can be correlated to symptomatic improvement following carpal tunnel~     release and therefore serve as a prognostic indicator.~      Clinical question: Does response to corticosteroid injection in CTS predict outcomes of~     surgical treatment?~      Secondary Questions:~        1. Can we confirm previous retrospectively collected data that a certain percentage of~          conservatively managed patients with steroid injection will avoid surgery, and that~          patients who undergo surgery will have better outcomes than those who do not.~        2. Are there differences between worker's compensation and non-worker's compensation~          patients with regard to the primary clinical question?~        3. What are Carpal Tunnel Release outcomes for the subset of patients with negative~          electrophysiologic studies?~        4. What are the outcomes of patients who undergo carpal tunnel release vs. those who choose~          not to undergo carpal tunnel release?~      A prospective cohort design study is the appropriate study design in order to measure the~     association between a predictor (response to injection) and outcome (response to surgery).~   "
221775|NCT00655902|"~     The aim of the present study is to assess the effect of a high intake of industrially~     produced trans fatty acids for 16 weeks on abdominal obesity and risk markers of type 2~     diabetes and heart disease in healthy, moderately overweight, postmenopausal women.~   "
221776|NCT00655889|"~     The purpose of this study is to evaluate the safety profile and the treatment effect of~     Isolagen TherapyTM in subjects with maxillary lesions who were treated in a previous study~     (IT-G-002)~   "
221777|NCT00655876|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal~     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by~     blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin~     together with radiation therapy is more effective with or without cetuximab in treating~     esophageal cancer.~      PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and~     cisplatin together with radiation therapy works with or without cetuximab in treating~     patients with locally advanced esophageal cancer.~   "
221778|NCT00655863|"~     The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by~     itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.~   "
221782|NCT00655811|"~     The purpose of this research is to study how people respond differently to capsaicin in~     different racial groups and the effect it has on your pain levels. Capsaicin is a natural~     product made from hot chili peppers that is useful for treating the itch symptoms of skin~     disease.~   "
221965|NCT00653419|"~     To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl~     Tablets~   "
221783|NCT00655798|"~     In the present study it is hypothesized that a reduction of the inflammatory status may~     prevent the occurrence of disorders and diseases related to overweight.~      In this study the effects of nutritional compounds will be studied in overweight men with a~     low grade inflammatory status. We will investigate the effects of 3 different food treatments~     as compared to a placebo on markers of inflammation and on parameters of glucose and fat~     metabolism. The three different food treatments are a food mix and two yogurts each~     containing different probiotic strains. The food mix is composed of a mix of nutritional~     components, each reported to affect inflammation parameters and (or) anti-oxidant status but~     different in their -hypothesized-mode of action.~   "
221784|NCT00655785|"~     The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402~     restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination~     with gemcitabine~   "
221785|NCT00655772|"~     A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.~   "
221786|NCT00655746|"~     The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of~     dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of~     dasatinib before and after 5 days of dosing with omeprazole in healthy subjects~   "
221787|NCT00655733|"~     Double-blind, randomized, multicenter, placebo-controlled study The purpose of this study is~     to evaluate the efficacy and safety of HMPL-004 in patients with active moderate Crohn's~     Disease,compared with placebo.~   "
221788|NCT00655720|"~     A study to evaluate the growth and development of term infants fed either an extensively~     hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an~     extensively hydrolyzed formula without probiotics~   "
221789|NCT00655707|"~     This is a prospective dose escalation study of the administration of adult human stem cells~     in patients with end stage liver failure. Successive groups of two patients will receive~     ascending doses of autologous adult human stem cells starting at 1x10[9] cells. Following~     expansion in an approved GMP facility the cells will be infused into either the hepatic~     artery or portal vein of research participants.~      The aim of this trial is to determine the maximum tolerated dose of autologous adult stem~     cells when infused into either the hepatic artery or the portal vein. The maximum dose that~     would be given would be 5x10 to the ten [10].~      To assess improvement in liver function as measured by serological and biochemical analysis~     and determine whether there are any symptomatic improvements as reported by the patients.~   "
221790|NCT00655694|"~     Chronic obstructive pulmonary disease (COPD) is a chronic disease characterized by~     progressive airflow obstruction, chronic cough and dyspnoea in advanced stages.~      Techniques such as genomics, proteomics and metabonomics, Technologies that aim to identify~     and quantify the dynamic set of all small molecules and metabolites present in an organism or~     a biological sample, offer the prospect of efficiently distinguishing individuals with~     particular diseases. The advantages of proteomics and metabonomics is that it can be carried~     out on a standard preparation of serum, plasma or urine, circumventing the need for~     specialist preparation of cellular mRNA required for genomics This methodology is based on~     mass spectrometry (MS), gas chromatography-mass spectrometry (GC-MS), and nuclear magnetic~     resonance (NMR) to analyze metabolites. High-performance liquid chromatography (HPLC) may~     also be applied. Several peak alignment algorithms have been developed to match the~     chromatograms before applying pattern recognition. Based on the pattern recognition, several~     potential biomarkers may be found and further identified by MS.. Finally, a number of~     potential biomarkers will be identified for distinguishing asthma and COPD.~      We hope to develop a better understanding of lung disease. Information from these studies~     will only be used for research purposes, to help develop safer and more effective treatments~     for asthma and COPD.~   "
221791|NCT00655681|"~     Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk~     for low bone density~      Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre~     operatively and studied with DXA scan. After surgery, children will be randomized to receive~     either pamidronate or saline. Repeat DXA scan will determine bone lost after end of~     immobilization or nonweightbearing.~   "
221792|NCT00655668|"~     This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide~     monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study~     will be conducted in two phases: a Treatment Phase and a Follow-up Phase.~      Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive~     single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles).~     Subjects may continue participation in the Treatment Phase of the study for a maximum~     duration of 24 months, or until disease progression or unacceptable adverse events develop.~      All subjects who discontinue the Treatment Phase for any reason will continue to be followed~     until progression of disease or until next lymphoma treatment is given, whichever comes~     first, during the Follow-up Phase.~      Objectives:~      Primary:~      • To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell~     Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor~     control rate, duration of response, time to progression and progression free survival.~      Secondary:~      • To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed~     or refractory T-cell NHL.~   "
221793|NCT00655655|"~     RATIONALE: Everolimus and vatalanib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving everolimus~     together with vatalanib may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus and~     vatalanib in treating patients with advanced solid tumors.~   "
221794|NCT00655642|"~     The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and~     promethazine for the treatment of nausea in the adult emergency department population.~      We hypothesize that a single intravenous dose of ondansetron is more effective in reducing~     nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in~     undifferentiated adult emergency department patients.~   "
221808|NCT00655460|"~     The Purpose of this study is to:~        1. Refine and validate a computerized bedside decision support tool blood glucose~          management in critically ill adult and pediatric ICU patients.~        2. Monitor how often low blood sugar levels occur during use of the bedside tool.~        3. Determine how the computerized tool effects the workload of the ICU nurses.~   "
221795|NCT00655629|"~     This study investigates the safety and efficacy of a new dosage form of Vardenafil, an~     orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo~     (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase,~     patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be~     determined by laboratory and other evaluations. Efficacy will be determined by the results of~     different questionnaires and the patient diary that will be used.~   "
221796|NCT00655616|"~     The purpose of this study is to determine whether patients with asthma who carry a genotype~     associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show~     greater benefit from the use of an asthma drug that works via alternative pathways like~     montelukast.~   "
221797|NCT00655603|"~     Incretinbased treatment of patients with type 2 diabetes mellitus (T2DM) has increasing~     interest. The incretin glucagon-like peptide-1 (GLP-1) stimulates beta-cells to increased~     secretion and production of insulin. Glucose sensitivity is enhanced, apoptosis inhibited -~     progression in disease is potentially stopped. The alpha-cell is also influenced by GLP-1 as~     infusion lowers plasmaglucose (PG) levels in patients with type 1 diabetes mellitus (T1DM)~     (C-peptide negative) by inhibition of glucagon and thereby decreased hepatic~     glucoseproduction (HGP). Further Vilsboll et al has proved normalization of the~     glacgonostatic effect of glucose in patients with T2DM. As an attempt to elucidate~     glucose-intolerance in patients with T2DM further Knop et al investigated the~     glucagonresponse to both oral glucose tolerance test (OGTT) and a following iso-glycemic~     clamp. He saw a sufficient suppression of glucagon when glucose was introduced intravenously~     but the suppression of glucagon was attenuated and delayed when glucose was given orally.~      The aim of this study is to elucidate the glucose intolerance further. Due to the complex~     interactions and mutual feed-back regulation between the pancreatic hormones and the PG level~     this protocol includes five days. All days include a euglycemic-clamp, patients with T2DM~     (n=10) are clamped at their fasting PG as are healthy control subjects (n=10). During the~     clamp either GLP-1 alone; GLP-1 in combination with somatostatin, insulin and glucagon; or~     somatostatin, insulin and glucagon are infused and blood samples are drawn.~      The design of the study makes it possible to isolate the effect of each hormone. Further the~     investigators will be able to enlighten the effect of GLP-1 on the increase in glucose~     turn-over it induces.~      The essential part in this design will be hormone concentrations and the response parameter~     the amount of glucose (AUC) it takes to create the euglycemic-clamp.~   "
221798|NCT00655590|"~     Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on~     sperm function~   "
221799|NCT00655577|"~     The significance of this population-based study is in producing new information for planning~     interventions and rehabilitation programs for the elderly, planning education of health care~     personnel and planning national health education programs for different age groups.~      The study consists of an epidemiological cross-sectional study and a randomized controlled~     intervention study. The study population consisted of all the 1689 home-dwelling women born~     during 1924-1927 residing in Oulu, Northern Finland, who were asked to a screening visit~     including bone mineral density (BMD) measurement of the distal radius in 1997. 1222 women~     attended the clinic and were afterwards mailed a postal questionnaire focusing on lifelong~     risk factors for osteoporosis, e.g. the amount of physical activity at work and during~     leisure time, daily intake of calcium and use of alcohol and cigarettes. Those with BMD value~     more than 20% lower than the reference value, underwent a densitometry of the hip. All women~     with femoral neck BMD more than 20% below the reference value (n=160) were randomly selected~     to either exercise (n=84) or control (n=76) group. At baseline and after that annually during~     the 30-month intervention, balance, muscle strength, aerobic capacity, walking speed,~     cognitive functions and mood are measured from all the participants. Hip BMD will be measured~     annually. The exercise group participates in a supervised training program with weekly~     sessions from the beginning of October to the end of April. In addition to the supervised~     sessions the participants train daily at home. From April to October the exercises are~     performed purely at home. The training regimen consists of balance, strength and impact~     exercises. The intervention group keeps diary of their daily physical activity. The number~     and severity of falls are recorded from both the groups.~      The purpose of the study is:~        1. to identify factors accounting for low BMD in elderly home-dwelling women with severe~          osteopenia.~        2. to evaluate how supervised regular weight-bearing exercise program affects BMD in~          elderly home-dwelling women with severe osteopenia~        3. to evaluate how supervised regular balance and muscle training affects balance and~          muscle strength in elderly home-dwelling women with severe osteopenia.~           In addition the aim is to:~        4. study how regular supervised exercise affects the incidence and severity of falls, mood~          and cognitive functions in women with severe osteopenia.~      Hypothesis and research methods~      The main hypothesis is that long-term supervised, mainly home- based regular impact-type and~     balance and muscle exercises can improve balance and muscle strength of lower extremities and~     maintain bone mass in elderly women. We also hypothesize that the incidence of falls is lower~     in the exercise group than in the controls and that the falls are more injurious in the~     control group than in the intervention group during the follow-up period~   "
221800|NCT00655564|"~     The purpose of this research study is to see how well the medication Alefacept (Amevive®)~     works for continuous treatment of chronic plaque psoriasis. The US Food and Drug~     Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg~     weekly injection for 12 weeks followed by 12 weeks off treatment.~   "
221801|NCT00655551|"~     The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered~     in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with~     partial-onset seizures.~   "
221802|NCT00655538|"~     This study will assess the safety, tolerability and efficacy of RO4607381 in patients with~     coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive~     either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by~     flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time~     on study treatment is up to 12 months, and the target sample size is up to 500 individuals.~   "
221803|NCT00655525|"~     The overall goal of this study is to examine the role of fish oil supplementation in~     ameliorating the inflammatory state of uremia and the related muscle protein catabolism~     associated with this disease state. We hypothesize that if administered for a period of 3~     months, fish oil will improve the chronic uremic inflammation. We further hypothesize that~     fish oil administration will improve the muscle protein breakdown associated with uremia and~     inflammation.~   "
221804|NCT00655512|"~     to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1%~     cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream~   "
221805|NCT00655499|"~     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     irinotecan, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving panitumumab together with irinotecan may kill~     more tumor cells.~      PURPOSE: This phase II clinical trial is studying giving panitumumab together with irinotecan~     to see how well it works as third-line therapy in treating patients with metastatic~     colorectal cancer.~   "
221806|NCT00655486|"~     The purpose of this study is to allow eligible subjects from the parent study, SP925~     [NCT00655551] to continue lacosamide and to obtain additional long-term safety data~   "
221807|NCT00655473|"~     This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic~     plaque in patients with coronary heart disease (CHD) including patients with other CHD risk~     factors. After a pre-randomisation period during which positron emission tomography computed~     tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either~     RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at~     intervals during the study. The anticipated time on study treatment is 2 years, and the~     target sample size is 100 individuals.~   "
221810|NCT00655434|"~     This study is designed to compare the performance of the Focus Diagnostics' HerpeSelect®~     Express, a Herpes Simplex Virus 2 Rapid Test, to a currently marketed device. The intent is~     to show the rapid test device is comparable to the currently marketed device. HerpeSelect®~     Express is a rapid test intended for qualitatively detecting the presence or absence of human~     IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (capillary).~   "
221811|NCT00655421|"~     A feasibility study to compare the test characteristics of three different oral cancer~     screening techniques performed by trained primary health care workers:1)Unaided Visual~     Inspection, 2)VelScope Assisted Examination, and 3) Examination after application of~     Toluidine Blue dye.~   "
221812|NCT00655408|"~     This work aims at establishing the effectiveness of weekly doses of ferrous sulfate~     administered by mothers compared with weekly supplements administered directly by healthcare~     professionals, to reducing anemia prevalence.~   "
221813|NCT00655395|"~     -  The purpose of the Phase I portion of this study is to evaluate the safety of this~          combination of medications and to determine the appropriate dose of VNP40101M to be used~          in combination with infusional cytarabine (araC) in elderly patients with Acute Myeloid~          Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS).~        -  The purpose of the Phase II portion of the study is to evaluate the effectiveness~          (overall response rate) for patients treated with VNP40101M and infusional cytarabine~          induction therapy.~   "
221814|NCT00655382|"~     The purpose of this study is to assess the effects of the Stapled Trans Anal Rectal Resection~     (STARR) procedure for patients with obstructive defecation syndrome. This involves a dynamic~     pelvic MRI and obstructive defecation score (ODS) at 6 month post STARR procedure.~   "
221815|NCT00655369|"~     In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive~     treatment effect relative to placebo on the primary endpoint, the weekly version of the~     Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of~     varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be~     explored in Nonrestorative Sleep subjects.~   "
221816|NCT00655356|"~     The purpose of this study is to evaluate the safety profile and the treatment effect of~     Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold~     wrinkles.~   "
221817|NCT00655343|"~     The study aim is to evaluate the influence of the anti-T-lymphocyte globulin ATG-Fresenius S~     given pre-transplant in addition to standard GvHD prophylaxis with cyclosporine A and a short~     course of methotrexate with respect to efficacy and safety.~   "
221818|NCT00655330|"~     This is a prospective randomized controlled, open-labeled study to identify the efficacy of~     probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction~     of urinary albumin or proteinuria will be the primary outcome studied. The expected study~     duration will be 48 weeks.~   "
221819|NCT00655317|"~     Postoperative ileus, the transient cessation of normal bowel function, is a universal aspect~     of colon surgery. Its occurrence may lead to increased patient discomfort and additional time~     and cost to hospital stay. Evidence from previous studies indicate that acupuncture may be~     beneficial in decreasing time to recovery of bowel function and decrease the body's~     inflammatory response. However, this has not been studied in a randomized, prospective~     fashion in colon surgery. The goal of this study is to determine if acupuncture may be~     utilized as a therapeutic modality to decrease time to return of bowel function and discharge~     from the hospital.~   "
221820|NCT00655304|"~     The main objective of this study is to investigate the effect of Prometheus liver support~     dialysis on intracranial pressure, cerebral metabolism and circulation in patients with acute~     liver failure.~   "
221821|NCT00655291|"~     The purpose of this study is to determine if XP20B is an effective treatment for the relief~     of pain following bunionectomy surgery.~   "
221822|NCT00655278|"~     This study will evaluate the safety and efficacy of T2000 when used to treat patients with~     moderate to severe essential tremor over an 18 month period.~   "
221823|NCT00655265|"~     This study is designed to assess whether colesevelam given as third line treatment added to a~     maximal tolerated and stable dose of a statin and ezetimibe is able to further decrease the~     level of LDL cholesterol in a safe and efficient manner in difficult to treat Familial~     Hypercholesterolaemia patients who are not at their target level of LDL cholesterol.~   "
221824|NCT00655252|"~     This expanded access study is designed to provide RAD001 to patients with MRCC who are~     without satisfactory treatment alternatives, until RAD001 becomes commercially available.~   "
221825|NCT00655239|"~     This study will evaluate the effectiveness of intensive computerized cognitive training in~     preventing the onset of psychotic disorder and improving adaptive functioning in adolescents~     at high risk of schizophrenia.~   "
221826|NCT00655226|"~     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is~     effective in the prevention of depression during interferon and ribavirin treatment for~     hepatitis C infection.~   "
221827|NCT00655213|"~     In case of sinus node dysfunction, it is often necessary to choose the safer option provided~     by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.~      In addition to saving energy, the latter mode allows spontaneous ventricular activation, the~     haemodynamic consequences of which are, in most cases, better than those obtained with dual~     chamber pacing.~      Recent studies as the MOST study suggest also that ventricular desynchronization imposed by~     right ventricular apical pacing even when AV synchrony is preserved increases the risk of~     atrial fibrillation in patients with SND. Similar results were already given by anterior~     studies (PIPAF) which, taking into account the percentage of ventricular pacing, suggested~     that AF prevention algorithm in combination with a preserved native conduction are efficient~     in reducing AF burden.~      However, current practice is to implant a dual chamber pacemaker to prevent the risk of~     atrioventricular block (AVB) even if DDDR pacing with a fixed long AV delay was found~     inefficient in reducing ventricular pacing and was associated with a high risk of~     arrhythmias.~      The Symphony 2550 cardiac pacemaker offers pacing modes that automatically switch from AAI(R)~     mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder,~     irrespective of whether or not these are accompanied by an atrial arrhythmia, returning~     spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. These 2~     particular modes are called the AAI SafeR and DDD/AMC (R) mode.~      The main differences between both modes are that (i) AAI SafeR does not trigger any AV Delay~     after a sensed or paced atrial event which allows long PR intervals or even limited~     ventricular pauses with no switch to DDD(R), while (ii) DDD/AMC (R) is able to optimize AV~     Delay after switching to DDD(R) according to measured spontaneous conduction times and to~     provide an acceleration in case of vaso-vagal syndrome. This pacing mode has previously been~     assessed in clinical studies.~      This study intends to demonstrate that the automatic modes switching significantly reduce the~     percentage of ventricular pacing in patients implanted with a spontaneous AV conduction and~     reduce the occurrence of atrial arrhythmias, on a mid-term follow-up period, in comparison to~     standard DDD pacing with long AVDelay.~   "
221832|NCT00655148|"~     The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial~     investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:~      A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line~     (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney~     cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5,~     and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection~     in the opposite thigh.~      Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for~     antibodies against diphtheria, tetanus, pertussis, polio and prp.~   "
221833|NCT00655135|"~     The objectives of this study were to assess the safety and tolerability of LDP-02 in patients~     with active Crohn's disease who were not receiving corticosteroids or immunosuppressives, to~     assess the ability of LDP-02 to reduce Crohn's disease activity, and to obtain~     pharmacokinetic (PK) and pharmacodynamic(PD)information for LDP-02 in patients with active~     Crohn's disease.~   "
221834|NCT00655122|"~     The primary objective was to study the clinical benefit with dalteparin sodium in~     thromboprophylaxis in primary care medical subjects. The secondary objective was a~     pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care~     medical subjects.~   "
221835|NCT00655109|"~     To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center,~     double-masked, randomized, placebo controlled parallel treatment conjunctival allergen~     challenge (CAC) study in patients with allergic conjunctivitis~   "
221836|NCT00655096|"~     This study will allow National Eye Institute (NEI) doctors the opportunity to examine people~     with eye disease, whether the diagnosis is known or not, to determine if they are eligible~     for other NEI research studies. No treatment is offered in this study.~      People of all ages with various eye conditions, including genetic conditions, eye movement~     disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be~     eligible for this study.~      Participants undergo various tests and procedures to diagnose or evaluate their eye disease.~     The procedures may include the following:~        -  Personal and family medical history~        -  Physical examination and blood tests, including genetic testing.~        -  Eye examination with dilation to measure visual acuity and eye pressure and to examine~          the front and back parts of the eye.~        -  Questionnaire about vision and daily activities.~        -  Conjunctival swab or lacrimal bland biopsy, or both: A sample of cells from the eyes is~          collected by swabbing the surface of the eye or by surgically removing a small sample of~          the surface of the eye or tear gland.~        -  Electroretinogram to examine retinal function: The subject sits in the dark with his or~          her eyes patched for 30 minutes. The patches are removed, the surface of the eyes is~          numbed, and contact lenses that can sense signals from the retina are placed on the~          eyes. The subject then watches flashing lights.~        -  Fluorescein angiography to examine the blood vessels in the eye: A dye is injected into~          a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A~          camera takes pictures of the dye as it flows through the blood vessels.~        -  Optical coherence tomography to measure retinal thickness: A machine used to examine the~          eyes produces cross-sectional pictures of the retina.~        -  Microperimetry to test how sensitive different parts of the retina are to changing~          levels of light. The subject sits in front of a computer and presses a button when he or~          she sees a light on the screen.~        -  Oculography to record eye movements: Eye movements are measured by contact lenses or~          goggles that the subject wears while watching a series of spots on a computer screen.~   "
221837|NCT00655083|"~     The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after~     single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral~     absorption is evaluated through the drug recovery in urine.~   "
221838|NCT00655070|"~     The purpose of this study is to evaluate whether the use application of low frequency~     ultrasound, administered by the Timi3 ultrasound device, increases myocardial blood flow to~     the heart, in subjects with reduced myocardial blood flow at rest (hibernating myocardium).~     The primary endpoint of the trial is to assess the increase in myocardial blood flow from~     baseline to post Timi3 Ultrasound treatment in a hypoperfused region of myocardium. Positron~     emission tomography (PET) imaging will be used to noninvasively evaluate cardiac blood flow.~     The hypothesis is that ultrasound increases blood flow in hibernating myocardium.~   "
221839|NCT00655057|"~     This study will examine changes in brain dopamine transporter activity before and after~     antidepressant therapy.~   "
221840|NCT00655044|"~     This study is conducted in Europe. The aim of this observational study is to evaluate the~     incidence of serious adverse drug reactions while using Levemir® under normal clinical~     practice conditions.~   "
221841|NCT00655031|"~     Pomegranate has a long history of use in folk medicine. There is vast data on the health~     benefits of pomegranate fruit and juice. Multiple studies have established the strong~     antioxidative effects of pomegranate polyphenols (primarily the ellagitannin punicalagin) and~     their health effects. A vast number of animal and human clinical studies have provided~     evidence on effect of pomegranate products on reducing symptoms of common cold, reducing~     blood pressure, improving endothelial function, anti-tumor activity, and its~     anti-atherosclerotic activity. This study will evaluate the protective effect of a~     pomegranate concentrate (POMx) in decreasing the incidence and duration of the common cold~     among healthy adults.~   "
221842|NCT00655018|"~     No proven treatment exists for nonalcoholic fatty liver disease (NAFLD) in children and~     adolescents. We aim to determine the efficacy of lifestyle intervention with or without~     antioxidant therapy in pediatric NAFLD.~   "
221843|NCT00655005|"~     RATIONALE: Collecting information by questionnaire about the quality of life of patients with~     head and neck cancer may help doctors learn more about the disease.~      PURPOSE: This clinical trial is testing a questionnaire for assessing pain control, head and~     neck symptoms, and general symptoms of illness, demographics, moods, alcohol and tobacco~     history, and quality of life related to cancer in patients with newly diagnosed head and neck~     cancer.~   "
221844|NCT00654992|"~     The purpose of this study is to determine whether erythropoietin is effective in preventing~     acute kidney dysfunction after coronary artery bypass grafting surgery.~   "
221845|NCT00654979|"~     To determine the safety and effectiveness of the SafeFlo filter for permanent protection~     against pulmonary emboli. All patients will be selected to receive the filter according to~     the stated inclusion / exclusion criteria after consultation between the attending physician~     and interventional radiologist. Patients with a permanent implantation will be followed for~     up to 6 months. Clinical success will be defined as no occurrences of any of the following~     events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of~     permanent filter patients considered to be a clinical success will be the primary efficacy~     parameter.~   "
221966|NCT00653406|"~     The purpose of this study is to explore the pharmacokinetic profile and safety after biweekly~     (every 2-week) intramuscular (IM) injections (6 injections) of risperidone long acting~     injectable 25, 37.5, or 50 mg/dose in schizophrenic patients. The efficacy of the study~     medication will also be assessed.~   "
221967|NCT00653393|"~     To compare the single-dose Bioavailability of Tranylcypromine and Parnate~   "
221846|NCT00654966|"~     Urotensin II (U-II) is newly discovered protein that may play an important role in human~     health and disease. U-II has been found to be a potent vasoconstrictor (narrower of blood~     vessels) which therefore may be involved in important diseases such as chronic heart failure~     - CHF (weak heart muscle disease). Many vasoconstrictors have been found to have effects on~     key organs such as the heart. Preliminary data by our group have demonstrated this is true of~     U-II. Recent evidence shows that in CHF, U-II levels in the blood are increased.~      The proposed study seek to determine the effect of blocking a possible downstream mediator of~     U-II on blood vessels by administration of soluble epoxide hydrolase inhibitor (sEHI). There~     will be 2 study groups 1) Healthy volunteers and, 2) CHF patients.~      Each arm of the study will run independently and will require 16 participants each (16 normal~     subjects and 16 CHF subjects). Participants will be screened to ensure that they are~     eligible. CHF patients will be required to withdraw from their CHF medication 24 hours prior~     to the study day (except for diuretics). On the study day, sEHI will be administered on the~     skin of participants in 3 asceding dosages. The technique to be used is iontophoresis. This~     is a non invasive technique in which a small amount of the compound is placed on the skin of~     the forearm. The drug is delivered across the skin by passing a small electric current over~     the area. The change in blood flow is then measured and analysed. We will also administer~     U-II agonist, noradrenaline, and distilled water (all via iontophoresis). Noradrenaline will~     be used a positive constrictor control. Change in blood flow will be assessed by Laser~     Doppler Velocimetry.~      If it is found that the sEHI is able to prevent blood vessel constriction in CHF patients,~     then it may represent a major therapeutic advance in the management of CHF.~   "
221847|NCT00654953|"~     To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in~     combination with gabapentin. The purpose of this study is to examine whether the~     antidepressant sertraline alone or combined with gabapentin delays time to relapse relative~     to placebo in recently abstinent cocaine-dependent volunteers who are also depressed. In~     addition, whether depressive symptoms or genetic factors influence treatment response to the~     study medications will be examined. Our hypothesis is that those on combined~     sertraline-gabapentin will show a longer period of abstinence than those on sertraline alone~     or placebo.~   "
221848|NCT00654940|"~     The purpose of this study is to assess whether a cross-over type study design in~     post-traumatic neuropathic patients can be used to assess the activity of potential analgesic~     agents~   "
221849|NCT00654927|"~     The purpose of this study is to evaluate the long-term safety, tolerability and activity of~     Fampridine-SR in subjects with multiple sclerosis who have previously participated in either~     an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible~     regardless of whether they received active drug or placebo during their participation in the~     previous study.~   "
221850|NCT00654914|"~     The primary objective of this study is to assess the efficacy together with safety of a~     flexible regimen, for a period of twelve weeks, of three doses (5 mg, 10mg and 20mg) of Bay~     38-9456, a phosphodiesterase type V inhibitor, in males with erectile dysfunction treated~     with sildenafil in the previous <6 months .At entry, once the Inclusion and Exclusion~     criteria are confirmed, the study medication will be administered for twelve weeks in an open~     label design. Vardenafil will be administered, as needed, at a fix dose of 10 mg once daily~     for the first four weeks of treatment. At the Investigators' discretion, on the basis of~     efficacy and safety evaluations, the patients may, then, receive the same dose strength of~     their assigned study medication or, at the subsequent clinic visit(s), the next lower dose (5~     mg vardenafil) or the next higher dose (20 mg vardenafil) for the subsequent four weeks of~     treatment. Previous dose level of vardenafil is either maintained, increased or decreased by~     one step according to the three applicable dose strengths (5 mg, 10 mg, 20 mg ). The highest~     dosage of vardenafil (20 mg) per day will not be exceeded. After twelve weeks of treatment,~     the patient will be contacted twenty four hours following the last visit in order to collect~     data concerning serious adverse events.~   "
221851|NCT00654901|"~     This is a follow-up of Study A3L11 (NCT00404651).~      Immunogenicity~        -  To describe the antibody persistence following a primary series vaccination of either~          DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.~        -  To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of~          subjects.~      Safety~      - To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.~   "
221852|NCT00654888|"~     To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and~     in patients without visual prediction.~      The automated lamellar keratectomy represents a alternative in treatment of pain in~     symptomatic patients with BK.~   "
221853|NCT00654875|"~     This study will compare the safety and efficacy of once daily dosing of aliskiren to twice~     daily dosing of aliskiren in patients with moderate hypertension~   "
221854|NCT00654862|"~     Intake of cocoa-containing foods has been found to lower blood pressure (BP) in several~     clinical trials. It is supposed that the cocoa polyphenols represent the active principle,~     lowering BP by increasing the formation of vasodilative nitric oxide. However, direct~     evidence for this assumption from controlled clinical studies is lacking. Moreover, in~     hypertensive subjects vascular dilation appears to be impaired due to endothelial dysfunction~     and vascular smooth muscle remodeling, but it is unclear whether the BP response to cocoa~     phenols differs between subjects with high blood pressure and optimal blood pressure.~      The investigators hypothesized that (1) intake of cocoa phenols cause a dose-dependent, acute~     elevation of circulating bioactive NO levels and a reduction in BP, and that (2) the NO~     elevation and BP reduction are impaired in patients with hypertension.~      To test this hypothesis, the investigators will conduct a prospective, randomized,~     placebo-controlled, double-blind, sample size-calculated, three-period crossover study with~     pre-planned statistical analysis and trial monitoring, in which cocoa phenols will be orally~     administered to subjects with mild essential hypertension or subjects with optimal blood~     pressure. The effects on blood pressure, heart rate, arterial function and plasma levels of~     cocoa phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress~     will be evaluated. After a 7-day cocoa-free run-in period and a 12-hour overnight fast, 48~     subjects (24 with hypertension and 24 sex-, and age (+/- 2yrs)-matched subjects with optimal~     blood pressure) will receive either a single dose of 1000 mg cocoa polyphenols, 250 mg cocoa~     phenols or placebo (in capsules of equal form and weight). Each intervention will be followed~     by a 7-day cocoa-free washout period before cross-over to the subsequent intervention.~     Subjects will be allocated to the intervention sequence by permuted block randomization (i.e.~     permuted blocks of 2 subjects with high BP and 2 subjects with optimal BP each, are assigned~     to permutations of the tree interventions). Measurements of hemodynamic and plasma parameters~     will be performed directly before and 30, 60, 90, 120, 180, 300, and 480 min after capsule~     administration. Included subjects will be counseled to maintain their usual diet and physical~     activity and to abstain from all cocoa products during the study. Analysis of the data will~     be performed on an intention-to-treat basis.~   "
221855|NCT00654849|"~     Objective: To compare the safety and efficacy of the use of bipolar plasmakinetic vessel~     sealing (Gyrus Pk) usage versus standard technique when performing total abdominal~     hysterectomy for benign disease.~      Material and Methods: controlled randomized trial involving 94 women who underwent total~     abdominal hysterectomy. 47 procedures were performed using bipolar plasmakinetic vessel~     sealing and the remaining 47 with the standard sutures technique. The primary outcomes were~     improvement in terms of blood loss, procedure time, length of hospital stay, and overall cost~     of the procedure. Statistical methodology considered significant P <0.05.~   "
221968|NCT00653380|"~     To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent~     to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals).~   "
221856|NCT00654836|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized~     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry cancer-killing~     substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood~     flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together~     with bevacizumab works in treating patients with locally recurrent or metastatic breast~     cancer.~   "
221857|NCT00654823|"~     We propose to develop a personalized pharmacogenetic approach including the major genetic~     markers of warfarin (coumadin) dosing and patients' age and weight. The known genetic~     determinants include several functional and common polymorphisms in CYP2C9 and VKORC1 genes,~     which explain the low-end of warfarin dosing range and mostly occur in patients of Caucasian~     and Chinese origins. We identified a new VKORC1 polymorphism that is specifically indicative~     of the high dose requirements and is dominant over the dose-reducing effect of the known~     CYP2C9 and VKORC1 markers. This marker is significantly over-represented in Jews of Ethiopian~     origin, but is also common in Ashkenazis, it is also linked to the VKORC1 genetic markers~     characteristic of the Afro-American population (published in Blood 2007, 109:2477-80). This~     information prompts the development of a more inclusive and universal diagnostic approach to~     the individualized warfarin therapy.~      The present study aims at evaluation of our novel pharmacogenetic model for predicting~     warfarin (coumadin) dose response on the basis of patient's genetic markers of warfarin~     sensitivity and resistance, and other patient specific factors. To this end, we proposes to~     re-evaluate our previously developed pharmacogenetic model in stabilized warfarin treated~     patients (N=200) and then to implement it in a prospective study of patients new on warfarin~     as compared to the traditionally treated patients (N=500).~   "
221858|NCT00654810|"~     The purpose of this study is to examine the effect of age and the effect of exercise~     intensity of rehabilitation programs on claudication pain symptoms and leg circulation of~     younger and older patients with intermittent claudication.~   "
221859|NCT00654797|"~     The Purpose of this study is to:~        1. Introduce the refined, validated, and safe computerized bedside decision support tool~          for blood glucose management in critically ill adult and pediatric ICU patients that was~          studied in Phase 1 into a second group of naïve ICUs, none of which participated in~          eProtocol-insulin development, refinement or validation~        2. Monitor how often low blood sugar levels occur during use of the bedside tool.~        3. Determine how the computerized tool effects the workload of the ICU nurses.~   "
221860|NCT00654784|"~     Idebenone is a synthetic analogue of coenzyme Q10 and is a powerful antioxidant and essential~     constituent of the process of energy production on the cellular level. It can protect~     mitochondria from oxidative damage and boost their impaired function. It is thought that this~     mechanism will slow decline in heart function that is part of the disease process of Duchenne~     Muscular Dystrophy (DMD). It is possible that patients may benefit in terms of muscle~     strength and respiratory function. This pilot trial is designed to investigate this.~   "
221861|NCT00654771|"~     The purpose of this prospective study was to examine whether protein/creatinine ratios in~     catheterized urine specimens correlate to clean catch specimens in pregnant patients being~     evaluated for preeclampsia.~   "
221862|NCT00654758|"~     The primary purpose of this study is to examine the safety of volociximab in combination with~     a standard treatment of carboplatin and paclitaxel in subjects previously untreated with~     chemotherapy for advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC).~   "
221863|NCT00654745|"~     To determine if olmesartan plus amlodipine combination therapy alone and with~     hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive,~     type 2 diabetic subjects.~   "
221864|NCT00654732|"~     The goal of this clinical research study is to compare the effectiveness of receiving~     Adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD)~     therapy alone to receiving ABVD with rituximab.~   "
221865|NCT00654719|"~     The purpose of this study was to determine the effects of a high caloric drink on weight and~     several other clinical markers including quality of life in patients with unintentional~     weight loss (cachexia) due to chronic heart failure.~   "
221866|NCT00654706|"~     The objective of this study is to explore the neurocognitive efficacy of Sertindole versus~     comparator in patients with schizophrenia using the MCCB.~   "
221867|NCT00654693|"~     -  Determine the accuracy of the NTX wireless monitoring system alerts~        -  Evaluate patient compliance with wearing device~        -  Determine false alarm rates~   "
221868|NCT00654680|"~     Investigate efficacy and safety of Vardenafil in patients with spinal cord injury~   "
221869|NCT00654667|"~     Sirtuin activators may prove useful in treating age-related diseases and extending lifespan~     in humans. Resveratrol (RSV), a polyphenol found in red wine, has been shown in vitro to~     enhance SIRT1 activity. RSV is associated with some of the beneficial effects of red wine or~     the French Paradox. Recently RSV has been associated with increasing lifespan in mice on a~     high calorie diet and improved metabolic profile and activity levels. The effect of this~     small molecule in humans is unknown. Preclinical observations suggest that RSV is safe and~     has enormous potential in the treatment of obesity and insulin resistance in humans. This~     pilot study will examine the effect of RSV on improving the metabolic profile of adults with~     insulin resistance. Specifically, this randomized double blind placebo controlled study will~     examine the effects of 4 weeks of supplementation with RSV 5.0 grams daily, compared to~     placebo control (PC) on the metabolic profile of 36 men and women over the age of 50 with~     insulin resistance (IR) consuming a typical western diet consisting of at least 40% calories~     from fat.~   "
221870|NCT00654654|"~     The purpose of this study is to evaluate the safety profile and the treatment effect of~     autologous human fibroblasts and placebo when administered to facial wrinkles and creases~   "
221969|NCT00653367|"~     The purpose of this study is to investigate if controlled nerve section reduces chronic pain~     after thoracotomy.~   "
241818|NCT00389350|"~     The objective of this study was to determine if taking an extract of green tea for three~     months could improve glucose control in adults with diabetes.~   "
221871|NCT00654641|"~     Wound complications after Cesarean section (C-section) are common in obese women.~     Approximately 25% of obese women having a C-section will have a wound complication. This~     research study is designed to assess whether applying a source of vacuum (suction) to the~     wound can reduce the risk of wound complications. The investigators plan to enroll 220 women~     into the study.~      Women will be randomly selected to receive standard stitching and stapling of the incision~     (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be~     seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of~     wound complications in each group will be compared. If the wound suction technique is~     successful in preventing wound complications, this may substantially reduce pain and~     suffering in a large number of women undergoing C-section for delivery.~   "
221872|NCT00654628|"~     The purpose of this study is to determine the safety and tolerability of~     ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.~   "
221873|NCT00654615|"~     Wrist fractures are the most common type of fractures that occur in the shoulder, arm, and~     hand. Approximately 250,000 to 300,000 wrist fractures occur in the United States each year.~     Although some wrist fractures can be treated using casts, many other fractures must be~     treated with surgery. The surgery involves using metal plates and screws to put the broken~     pieces of bone together so that they can heal. The purpose of this study is to compare two~     specific types of surgery that are used to treat broken wrists. One type uses pieces of metal~     that are placed on the outside of the broken pieces of bone that are screwed in place while~     the broken bones heal. The other type of surgery involves placing a piece of metal inside the~     bone marrow to hold the broken pieces of bone together as they heal. Individuals with broken~     wrists who participate in this study will be randomly assigned to receive one of the two~     types of surgical treatment. Both surgical treatments are approved and are not experimental.~     Study participants will be followed closely after surgery to determine the time required for~     them to return to their usual daily activities involving the use of their arms and hands.~     Although both groups of study participants are expected to experience the same outcomes at~     one year, those participants that receive the device placed inside the bone marrow may return~     to their normal functional activities earlier than the ones treated with the plate placed on~     the outside of the bone. Study participants and their surgeons will complete data sheets and~     questionnaires that will document their progress following treatment of their wrist~     fractures.~   "
221874|NCT00654602|"~     The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing~     low density lipoprotein cholesterol levels to internationally recognised goals in subjects~     with dyslipidaemia.~   "
221875|NCT00654589|"~     The purpose of this study is to investigate the effects of iron chelation using deferasirox~     in patients who show signs of iron overload after an allogeneic stem cell transplantation The~     iron overload must be due to blood transfusions.~   "
221876|NCT00654576|"~     Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high~     discontinue rate.To solve these problems, we provide practical and available psychosocial~     intervention. We hypothesize that there will be significant difference in the overall~     effectiveness between antipsychotic and antipsychotic combination with psychosocial~     intervention.~   "
221877|NCT00654563|"~     The study is designed to collect data regarding the clinical course and outcome of patients~     suffering from memory disorders. Visits are charged to the individual's insurance inclusive~     of Medicare. Patients benefit from expert evaluation and treatment recommendations.~     Participants may be eligible for participation in experimental treatments in the future.~   "
221878|NCT00654550|"~     Phase 1 randomized, prospective, double-masked, vehicle-controlled, dose-escalation study to~     evaluate the safety, tolerability and clinical effect of Nexagon™ in subjects following~     bilateral PRK for the correction of mild to moderate myopia.~   "
221879|NCT00654537|"~     To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin &~     simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with~     hypercholesterolaemia.~   "
221880|NCT00654524|"~     The purpose of this study is to identify the recurrent rate and pregnancy rate of advanced~     endometriosis after laparoscopic surgery plus GnRHa goserelin acetate treatment.~   "
221881|NCT00654511|"~     The primary purpose of this study is:~        1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and~          post-operative analgesia.~        2. To determine an analgesic dose response relationship for dexmedetomidine.~        3. Compare recovery characteristics of dexmedetomidine to fentanyl.~   "
221882|NCT00654498|"~     To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared~     to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)~   "
221883|NCT00654485|"~     The purpose of this study is to compare the efficacy of treatment with rosuvastatin with~     atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in~     subjects with metabolic syndrome.~   "
221884|NCT00654472|"~     To compare mitral valve area in rheumatic mitral valve stenosis with cardiac magnetic~     resonance imaging and conventional transthoracic echocardiography.~   "
221885|NCT00654459|"~     Some nutraceuticals are often advised for their lipid lowering effects. Although many~     clinical trials have been conducted to assess their efficacy many doubts remain whether they~     could be considered an effective alternative to statins therapy.~      The aim of this study was to evaluate the lipid lowering effects and the improvement of~     endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product~     (Armolipid Plus)~   "
221886|NCT00654446|"~     The purpose of this study is to assess the effects on the kidney of rosuvastatin and~     simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia~   "
221887|NCT00654433|"~     Eligible research subjects will receive an unrelated umbilical cord blood transfusion as a~     possible cure for their inherited metabolic disease. A portion of cord blood cells (ALD-101)~     will be separated from the cord blood unit and given approximately 4 hours after the standard~     cord blood transfusion.~      The study will test if the supplemental cells will increase the speed at which normal levels~     of circulating blood cells are re-established after transplant.~   "
221970|NCT00653354|"~     To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib~     compared to placebo on the first post-operative day in patients with moderate or severe pain~     following bunionectomy surgery.~   "
221888|NCT00654420|"~     This is a Phase I/IIa study to evaluate safety and efficacy of dalotuzumab (MK-0646) in~     combination with erlotinib in participants with recurrent Non-Small Cell Lung Cancer (NSCLC).~     The Phase I part of this study will determine the highest tolerated dose of dalotuzumab to be~     given in combination with erlotinib. The primary hypothesis for the Phase I part of the study~     is that administration of erlotinib in combination with dalotuzumab in participants with~     recurrent NSCLC is generally well-tolerated as evidenced by accumulated safety data from this~     trial. The Phase II part of this study will investigate how well dalotuzumab works in~     conjunction with erlotinib at treating recurrent NSCLC. The primary hypothesis for the Phase~     II part of this study is that administration of erlotinib in combination with dalotuzumab in~     participants with recurrent NSCLC results in improvement in Progression Free Survival (PFS)~     compared to participants treated with erlotinib alone. PFS is defined as the time from~     randomization until either the emergence of radiographic evidence of disease progression (as~     documented by an independent core laboratory) or death due to any cause, whichever occurs~     first.~   "
221889|NCT00654407|"~     The purpose of this study is to determine whether treatment with rosuvastatin following~     atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk~     of Coronary heart disease compared to atorvastatin and simvastatin alone.~   "
221890|NCT00654394|"~     The purpose of this study is to examine the changes in the carotid artery when subjects~     receive high or low doses of rosuvastatin.~   "
221891|NCT00654381|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and~     voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with~     insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension~     treatment to 52 weeks.~   "
221892|NCT00654368|"~     The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid~     arthritis with or without methotrexate treatment over a 24 month period~   "
221893|NCT00654355|"~     The purpose of this research study is to better understand how the study drug works when~     people use it to treat atopic dermatitis.~   "
221894|NCT00654342|"~     The technique of sentinel lymph node mapping in patients with colon cancer varies among~     reports, and the optimal method remain to be established. The purpose of this study was to~     determine the optimal injection technique for sentinel lymph node mapping for colon cancer.~   "
221895|NCT00654329|"~     A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an~     α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.~   "
221896|NCT00654316|"~     Tuberculosis (TB) kills about three million people annually. It is estimated that one third~     of the world's population are latently infected with Mycobacterium tuberculosis (M.tb).~     Multi-drug resistant strains of M.tb, and co-infection with M.tb and HIV present major new~     challenges. The currently available vaccine, M. bovis BCG, is largely ineffective at~     protecting against adult pulmonary disease in endemic areas and it is widely agreed that a~     new more effective tuberculosis vaccine is a major global public health priority1. However,~     it may be unethical and impractical to test and deploy a vaccine strategy that does not~     include BCG, as BCG does confer worthwhile protection against TB meningitis and leprosy. An~     immunisation strategy that includes BCG is also attractive because the populations in which~     this vaccine candidate will need to be tested will already have been immunised with BCG.~      M.tb is an intracellular organism. CD4+ Th1-type cellular responses are essential for~     protection and there is increasing evidence from animal and human studies that CD8+ T cells~     also play a protective role2. However, it has generally been difficult to induce strong~     cellular immune responses in humans using subunit vaccines. DNA vaccines induce both CD4+ and~     CD8+ T cells and thus offer a potential new approach to a TB vaccine. DNA vaccines encoding~     various antigens from M. tuberculosis have been evaluated in the murine model, and to date no~     DNA vaccine alone has been shown to be superior to BCG.~      A heterologous prime-boost immunisation strategy involves giving two different vaccines, each~     encoding the same antigen, several weeks apart. Such regimes are extremely effective at~     inducing a cellular immune response. Using a DNA- prime/MVA-boost immunisation strategy~     induces high levels of CD8+ T cells in animal models of malaria and HIV5, and high levels of~     both CD4+ and CD8+ T cells in animal models of TB. BCG immunisation alone induces only CD4+ T~     cells in mice. A prime-boost strategy using BCG as the prime and a recombinant MVA encoding~     an antigen from M.tb that is also present in BCG (antigen 85A: 'MVA85A') as the boost,~     induces much higher levels of CD4+ T cells than BCG or MVA85A alone. In addition, this regime~     generates specific CD8+ T cells that are undetectable following immunisation with BCG alone.~   "
221897|NCT00654303|"~     The purpose of this study is to assess the long term safety of Crestor.~   "
221898|NCT00654290|"~     Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently~     B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of~     propranolol and amiodarone separately and together to find a better prophylaxis for AF~     peri-CABG~   "
221899|NCT00654277|"~     To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT~   "
221900|NCT00654264|"~     This is an unblinded pilot study comparing (against a randomized control day without water~     immersion) the diuretic and natriuretic effects of water immersion in patients with right~     heart failure.~   "
221901|NCT00654251|"~     Measuring the various difficulties patients with spinocerebellar ataxias (SCA) report in an~     accurate manner is important to be able to test any therapy that may be developed. As basic~     research identifies some therapy of this type, clinicians are planning studies that can~     either prove or disprove that such treatments actually have an effect. Walking problems and~     problems with eye movements that can give rise to visual complaints are common in the SCA's.~      Existing neurological scales such as the SARA are based on the usual neurological~     examination items that can carry a degree of subjective bias. Also the intervals between~     numbers on such scores often do not carry the same weight so that the difference between a~     score of 1 and 2 may not be equal to difference between 2 and 3. Lastly, such scales done in~     the clinic setting capture only a brief period of a patient's day. We propose that~     examination of home based gait monitoring, timed tests of motor function and quantitative~     measures of visual problems in patients with SCA are more useful in measuring the disability~     in these patients.~   "
221902|NCT00654238|"~     The goal of this study is to determine the activity of sorafenib in patients with advanced~     (metastatic or recurrent) thyroid cancer.~   "
221903|NCT00654225|"~     The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin~     with 6 weeks of treatment with Atorvastatin in South Asian subjects with~     hypercholesterolemia.~   "
221904|NCT00654212|"~     Objective: Whether temporary endoscopic decompression by Self-expanding metal stents (SEMS)~     could allow these patients to undergo successful laparoscopic resection (endo-laparoscopic~     approach) has never been previously studied. This randomized trial aims to compare this~     approach with emergency open surgery in the management of obstructing left-sided colon~     cancer.~   "
221905|NCT00654199|"~     The purpose of this study is to:~        1. assess the existence of inter-ventricular and intra-ventricular asynchrony in cardiac~          surgery patients before (PRE) and after cardiopulmonary bypass surgery (POST)~        2. investigate whether a modification of usual pacing practices (RA-LV pacing) can achieve~          inter- and intra-ventricular synchrony and improve heart function, as evaluated by~          hemodynamic and echocardiographic indexes, when compared with the patient's native~          rhythm (normal sinus rhythm (SR), or conventional pacing modes~   "
221906|NCT00654186|"~     This is a single institution, open label, phase II study in androgen-independent prostate~     cancer patients who are chemotherapy-naïve. Patients will receive Revlimid® 25 mg daily on~     Days 1-21 followed by 7 days of rest repeated every 28 days. Treatment continues until~     disease progression, patient's withdrawal, unacceptable toxicity or the investigator's~     discretion.~   "
221907|NCT00654173|"~     The purpose of this study is to compare the efficacy and safety of rosuvastatin with~     simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in~     subjects with hypercholesterolaemia~   "
221908|NCT00654160|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when~     given together with fluorouracil and leucovorin in treating patients with advanced~     gastrointestinal cancer.~   "
221909|NCT00654147|"~     A prospective, randomized, open-label pilot study to assess virologic suppression and~     immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the~     protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and~     two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.~      Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and~     subpopulations (regulatory T cell [T regs], TH-17 and TH1) after treatment initiation with~     Raltegravir based regimens and their relationship with functional CD8 T cells and if~     Raltegravir containing therapies leads to decreases in markers of gut microbial translocation~     and of cellular and soluble markers of immune activation.~   "
221910|NCT00654134|"~     The purpose of this study is to determine the inflammatory response to 20,000 endotoxin units~     (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy~     volunteers. Preferably these subjects will have participated in ozone exposure studies,~     allowing a direct comparison of their responses to both endotoxin and ozone. Additionally,~     cardiovascular endpoints will be investigated with the CCRE exposure.~   "
221911|NCT00654121|"~     Prophylactic administration of metabolically active insulin can prevent or delay clinical~     onset of diabetes in a high risk group of nondiabetic siblings as defined by positivity for~     autoantibodies against IA-2 (IA-2-A).~   "
221912|NCT00654108|"~     Enterotoxigenic Escherichia (E.) coli (ETEC) bacteria are the main cause of traveler's~     diarrhea and are significant pathogens affecting children and elderly individuals of~     developing countries. The purpose of the study is to determine the safety of the ETEC-Cholera~     vaccine and the body's ability to protect itself against ETEC and cholera infection after~     receiving the vaccine. The study will enroll a total of 64 healthy volunteers, 18 to 45 years~     old at the Cincinnati Children's Hospital. The study will provide increasing doses of the~     vaccine or placebo (inactive substance) to 4 groups consisting of 16 participants each.~     Participants will remain in the inpatient unit for observation for about 11 days. All~     subjects will be treated with Cipro, an antibiotic, for 5 days. Study procedures include:~     blood samples, vital signs, physical examinations, and stool samples. Volunteers will be~     involved in the study for about 8 months including telephone contacts.~   "
221913|NCT00654095|"~     Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin~     in participants with hypercholesterolemia who have not reached low density lipoprotein~     (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase~     inhibitors.~   "
221914|NCT00654082|"~     To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as~     required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED)~     associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL)~     of these patients.~   "
221915|NCT00654069|"~     The purpose of this study is to determine whether oxycodone HCl and niacin are effective in~     the treatment of pain following bunionectomy surgery.~   "
221916|NCT00654056|"~     The purpose of the study is to investigate some of the mechanisms behind severe insulin~     resistance and to determine the dose response to insulin in patients with type 2 diabetes~     mellitus.~   "
221917|NCT00654043|"~     To compare the single-dose bioavailability of Torsemide tablets with Demadex~   "
221918|NCT00654030|"~     Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective~     immune response to kill tumor cells.~      The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients~     with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial~     definitive therapies.~   "
221919|NCT00654017|"~     The study was done to evaluate the efficacy, safety, and tolerability of orally administered~     sildenafil taken as needed about one hour before sexual activity after a 10-week period in~     male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.~   "
221920|NCT00654004|"~     Several hormones involved in body weight regulation increase the subject's ability to burn~     fat for energy. The purpose of this study is to investigate how burning fat for energy may~     affect those hormones and body weight in children. The study will also determine if eating a~     diet higher in protein alters the amount of fat you burn and how these hormones control body~     weight.~   "
221921|NCT00653991|"~     This study will evaluate the effectiveness of an interactive virtual environment computer~     game in reducing risky sexual behaviors among men who have sex with men.~   "
221922|NCT00653978|"~     The aim of the present study was to compare the effect of unilateral versus bilateral~     stenting in patients with malignant hilar obstruction.~   "
221923|NCT00653965|"~     The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin~     with 6 weeks of treatment with Atorvastatin in Hispanic subjects with hypercholesterolemia~   "
221924|NCT00653952|"~     The objective of this study is to compare the efficacy and safety of CAELYX versus Paclitaxel~     HCl in patients with epithelial ovarian carcinoma following failure of first-line,~     platinum-based chemotherapy. The primary endpoint is time to progression (TTP) following~     treatment with either CAELYX or Paclitaxel HCl; the secondary endpoints are response rates,~     time to response, duration of response,quality of life assessment, and survival following~     treatment with either CAELYX or Paclitaxel HCl. Up to a total of 438 protocol-eligible~     patients with epithelial ovarian carcinoma following failure of first-line, platinum-based~     chemotherapy will be enrolled in order to obtain 350 evaluable patients.~   "
221925|NCT00653939|"~     The purpose of this study is to determine the safety, tolerability and efficacy of~     combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with~     bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve~     non-small cell lung cancer (NSCLC). This is a randomized parallel arm study. All participants~     will receive carboplatin, paclitaxel and bevacizumab, and half will additionally receive~     CA4P. Patients who complete the first 6 cycles of therapy and have not experienced disease~     progression will receive maintenance therapy with bevacizumab alone or with bevacizumab plus~     CA4P.~      The rationale for this study is the potential additive or synergistic actions of vascular~     disrupting agents like CA4P with anti-angiogenic agents like bevacizumab.~   "
221926|NCT00653926|"~     The primary aim of this study is to evaluate if intra- and postoperative administration of~     ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay.~     Secondary end-points are morphine consumption, pain intensity and side effects. In an attempt~     to assess the safety of this technique, knee function and patient satisfaction scores are~     assessed up to 6 months after surgery.~   "
221927|NCT00653913|"~     This study was designed to evaluate the pharmacokinetic interaction and safety of~     coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male~     subjects or adult male subjects having no obvious disease other than high cholesterol levels.~   "
221928|NCT00653900|"~     A large number of patients are currently on Antiplatelet inhibition using aspirin or Plavix~     therapy (A Thieno pyridine - ADP mediated platelet inhibitor). A group of these patients~     often require Cardiac and/or Vascular surgical procedures. These patients are at a higher~     risk for perioperative bleeding complications and higher re-operation/re-exploration for~     bleeding and subsequent blood product transfusions.~      The aim of this protocol is to assess platelet function via the Verify Now device prior to~     surgery. The Verify Now device requires a small drop of fresh blood for each sample and is an~     FDA approved device.~      Our initial goal is to establish if a certain degree of platelet function abnormality can~     predict a higher bleeding complication or higher transfusions (Phase I, 20 patients). This~     initial study will allow us to determine a sample size for Phase II. Phase II will maintain~     the same protocol, however after completion of Phase I, a more accurate sample size~     determination can be made. Additionally, we want to establish if knowledge of platelet~     dysfunction will change procedure technique or preparation to lower bleeding and/or lead to~     cancellation/rescheduling of procedure (Phase III).~      Participants will be those patients who are taking plavix and are undergoing vascular or~     cardiac surgery. They will undergo a platelet function evaluation measured as Platelet~     Response Unit (PRU) via the verify now device on admission/pre surgery. This test involves~     taking 1 drop of blood from the patient, one time, before the procedure. The Verify Now~     device is FDA approved.~      Perioperative bleeding will be assessed by absolute drop in hematocrit immediate post-op~     compared to the immediate preoperative value. An additional discharge hematocrit will be used~     if no blood products have been used during the initial hospital stay. Hematocrit evaluation~     via a complete blood count is a part of standard patient care. Additionally, utilization of~     blood products (factors, PLT, PRBC's, etc.) will be assessed.~      In order to conduct the research, patients will be identified by reviewing the OR schedule.~     All consecutive patients on ASA/Plavix will be mailed a letter in order to introduce them to~     the study. The letter provides a phone number to call if the patient does NOT want to receive~     a phone call from the investigative staff. This letter is uploaded under item 18-02 of the~     study application. If patients do not call the office, then the investigative staff will call~     the potential participants to introduce the study. Final consent will be completed in PACU on~     arrival at the hospital for planned surgical procedure.~      A Hematocrit will be performed on the consented patient preoperatively, immediately post-op,~     and at discharge. A PRU will be assessed using a few drops of the patients' blood~     preoperatively (PACU). Patients' records will be reviewed to assess use of blood products. No~     additional follow up is required.~      Patients' care will be no different than current standard of care, other than the 1 verify~     now test, which is done before the procedure.~   "
221929|NCT00653887|"~     Looking for a modification of the cortical excitability of the motor area corresponding to~     the external anal sphincter after biofeedback sessions.~   "
221930|NCT00653874|"~     Objectives: Bilirubin measured by transcutaneous bilirubinometry (TcB) is a reasonably~     accurate estimate of serum total bilirubin (STB). Observational studies indicate that~     replacing clinical assessment of bilirubin (CaB) with TcB may result in reduced need for~     blood sampling for STB estimation. Objective of this study was to determine if routine use of~     transcutaneous bilirubinometry decrease the need for blood sampling for confirmation of STB~     in healthy term and near term neonates?~      Study design: Study was conducted as a randomized controlled trial at a tertiary care~     neonatal unit. Healthy neonates born at 35 or more completed weeks of gestation were eligible~     for enrolment if they had clinically evident jaundice during first week of life. In each~     enrolled neonate, level of jaundice was assessed by two methods - CaB followed by TcB~     (BiliCheck®, SpectRx Inc, Norcross, GA). By random allocation method, one of these estimates~     was used for deciding the need for blood sampling to confirm STB. Need for blood sampling was~     defined to be present if the bilirubin assessed by the allocated method exceeded 80% of~     age-specific cut-off for phototherapy as per American Academy of Pediatrics 2004 guidelines.~     Study had ethics clearance and written informed consent was obtained from parents.~   "
221931|NCT00653861|"~     Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™~     without Lidocaine for procedural pain in the treatment of nasolabial folds.~   "
221932|NCT00653848|"~     As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour~     burden it should be effective in primarily treated intermediate and high risk prostate cancer~     as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be~     tested in a randomised phase III trial where patients will be randomized either to docetaxel~     or surveillance~   "
221933|NCT00653835|"~     This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg~     will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C~     concentrations when administered for 6 weeks.~   "
221934|NCT00653822|"~     The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties~     and safety profile of alefacept in Caucasian and Japanese healthy subjects~   "
221935|NCT00653809|"~     The goal of this study is to examine the activation of markers of endothelial and~     cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this~     study will hopefully provide enough information to determine a link between race, the advent~     of high risk pregnancies and cardiovascular markers. With this information it might be~     possible to intervene with approved pharmacological treatments.~   "
221938|NCT00653770|"~     This is a Phase I study whose primary outcome is to assess the safety of a new tuberculosis~     vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost~     regime, to healthy volunteers, who have previously been vaccinated with BCG. The secondary~     outcome is to assess the cellular immune response in the same population. The trial consists~     of 36 subjects in 3 groups. The first group will be vaccinated with FP85A alone, the second~     group will be vaccinated with MVA85A followed by FP85A 28 days later and the third group will~     be vaccinated with FP85A followed by MVA85A 28 days later.~   "
221939|NCT00653757|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Using scintigraphy~     to plan specialized radiation therapy that delivers a high dose of radiation directly to the~     tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase I/II trial is studying the side effects and best way to give~     intensity-modulated radiation therapy and to see how well it works in treating patients with~     stage I, stage II, stage III, or stage IV prostate cancer.~   "
221940|NCT00653744|"~     The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin~     with 6 weeks of treatment with Atorvastatin in African American subjects with~     hypercholesterolemia.~   "
221941|NCT00653731|"~     The purpose of this study is to determine whether the interventions of Snoezelen, structured~     reminiscence therapy and 10-minutes activation are effective to reduce apathy in long term~     care residents with dementia.~   "
221942|NCT00653718|"~     In 2005, the EBCIG demonstrated the efficacy of tamoxifen in improving overall survival in~     hormone receptor positive breast cancers. However, tamoxifen shows partial estrogen agonist~     activity, which is responsible for the drug's detrimental effects such as endometrial~     carcinoma, thromboembolism, and tamoxifen resistance. More recently, aromatase inhibitors~     have been shown to be superior to tamoxifen in the metastatic and adjuvant settings. The ATAC~     trial demonstrated improved disease-free survival (DFS) for 5 years of anastrozole compared~     to 5 years of tamoxifen 3. The BIG 1-98 trial results demonstrated that after a median~     follow-up of 25.8 months, letrozole improved DFS and distant DFS when compared to tamoxifen.~     Based on these results, adjuvant hormonal therapy with Aromatase Inhibitors (AI) has become~     the preferred therapy for post-menopausal woman.~      However, AI therapy is also associated with toxicities that merit in-depth studies, one of~     them being an increase in musculoskeletal pain. In the ATAC trial, at a median follow-up of~     5.7 years, arthralgia was significantly higher (35.6% vs. 29.4%) and fractures were also~     increased (11.0% vs. 7.7%) when anastrozole was administered for 5 years following surgery~     with or without chemotherapy 3. The incidence of arthralgia was also significantly higher in~     the MA-17 trial, with 25% of patients receiving letrozole developing arthralgia compared with~     21% in the placebo group following 5 to 6 years of tamoxifen 5.~      Traditionally in cancer clinical trials, the reporting of musculoskeletal pain has been based~     on the Common Terminology Criteria for Adverse Events, which covers a wide range of~     symptoms and does not facilitate the documentation of a pain syndrome in a specific manner.~     Therefore, there is a need to design a study that will describe the nature of the pain~     associated with the administration of AI therapy using tools that have been validated for~     capturing a multidimensional phenomenon such as pain.~   "
221943|NCT00653705|"~     The aim of our study is to assess the effect of daily consumption of yogurt containing~     probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in~     out of home child care.~   "
221944|NCT00653692|"~     This project examines fetal neurobehavior and maternal physiology in poly-drug dependent~     women. This study also evaluates infant neonatal abstinence syndrome, infant neurobehavior~     and vagal tone in the post-partum period.~   "
221945|NCT00653679|"~     This study examines the muscle protein signalling response after resistance and endurance~     exercise. We hypothesize that the signalling response after endurance and resistance exercise~     will be partly similar.~   "
221946|NCT00653666|"~     The purpose of this study is to learn more about how long children with CPT-1 deficiency can~     wait between meals without developing low blood sugar or symptoms of low blood sugar. The~     other purpose is to learn more about how much fat is stored in the liver of a child with~     CPT-1 deficiency.~   "
221947|NCT00653653|"~     Using a prospective study design of two three month periods (before and after genotyping) in~     which the patients will self-monitor their health status and possible medical events it is~     hypothesized that it will be shown that patients having their medication altered to fit their~     genetic status and/or having their medication altered because of inherent interaction~     potential will have less recordable events after genotyping and medical analysis than before.~      It is well known that ADRs (recordable adverse events to medication) are responsible for a~     large number of deaths and hospitalizations. Furthermore it is well recorded that genotyping~     of individual cytochrome P450 enzymes (2D6, 2C9, 2C19, among others) is directly related to a~     metabolic phenotype - fast metabolisers, slow metabolisers, intermediate and normal~     metabolisers. These differing phenotypes have altered metabolism of many medications and in a~     number of retrospective clinical trails it has been shown that ADRs and effect can be~     reduced/bettered through genotyping and alteration of medication.~   "
221948|NCT00653640|"~     The purpose of this study is to determine whether body weight supported treadmill training is~     more effective than traditional physical therapy at restoring gait in persons recovering from~     traumatic brain injury.~   "
221949|NCT00653627|"~     This is a human pilot study of 16 healthy BCG-naïve volunteers to quantify BCG from the BCG~     vaccination site. Volunteers will be vaccinated with BCG. The first 8 will go on to have a~     punch biopsy and suction blister of the vaccination sites at 2 weeks post vaccination (arm A)~     the second 8 will have a biopsy and blister at 1 or 4 weeks post-vaccination (arm B). Methods~     of mycobacterial quantification on these tissue samples will then be compared~   "
221971|NCT00653341|"~     The primary objective of this study is to compare the percentage of subjects who reach the~     target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal~     hypoglycemia during treatment with insulin glargine or NPH human insulin.~   "
221972|NCT00653328|"~     RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors~     may be in combination with chemotherapy. The optimal use of atrasentan may be in combination~     with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube cancer,~     and peritoneal serous papillary adenocarcinoma. Due to its manageable toxicity profile, ease~     of administration, and activity in both platinum sensitive as well as platinum-resistant~     patients, Doxil has become the 2nd-line treatment of choice for women with advanced stage~     ovarian cancer that has progressed following 1st-line platinum/taxane therapy.~      PURPOSE: To determine if a treatment combination of atrasentan + Doxil is an effective 2nd~     line treatment in patients with recurrent ovarian cancer, fallopian tube cancer, or~     peritoneal cancer.~   "
221973|NCT00653315|"~     To compare the relative bioavailability of Kali and Ortho-McNeil's~   "
221950|NCT00653614|"~     The study will be performed as a multi-center, randomized, double-blind, parallel-group trial~     in fertile women aged between 18 and 35 years inclusive. A total of 600 volunteers will be~     randomized into one of the six treatment groups. The study will be performed only in Germany.~     The investigational drug is an oral contraceptive. It contains the estrogen estradiol (E2)~     and the progestogen drospirenone (DRSP). As the contraceptive efficacy has not yet been~     proven for these new regimens, even a protection against unwanted pregnancies cannot be~     assured. The treatments will be applied daily for 7 cycles of 28 days each without pill-free~     interval, i.e., for 196 consecutive days. Treatment will be initiated after a screening~     period of approximately 1 to 2 weeks, the latter focused on confirmation of the baseline~     safety status. Tablet intake will start on the first day of the first menstrual/withdrawal~     bleeding after Visit 2, regardless of whether the volunteer is a first user (starter) or~     switching from another COC. In the following cycles, tablet intake is not to be triggered by~     any bleeding events. The primary objective of this study is to evaluate and compare the cycle~     control and bleeding patterns of six different treatment regimens with E2/DRSP during~     administration for 7 treatment cycles. Volunteers will be provided with a diary to document~     the intake of study medication, any bleeding events, and days without bleeding, pregnancy~     test results. Safety will be also assessed. During the whole study period, 4 visits are~     planned. At Screening and Final examination, a thorough physical examination and a~     gynecological examination (including breast palpation and cervical smear ) will be performed.~     Blood samples will be taken for safety laboratory parameters.Additional examinations can be~     performed any time, if this becomes necessary for medical reasons. At Visit 3 or in case of~     premature discontinuation of study the investigator will discuss options for follow-up~     contraception with the volunteer. The volunteer can start the intake of a post-treatment OC~     on the day after the last tablet intake of study medication, after a negative urine ß-HCG~     test (home pregnancy test) result.~   "
221951|NCT00653601|"~     Patients who have undergone placement of coronary stents require dual antiplatelet therapy~     with Plavix and aspirin to prevent the serious complication of in-stent thrombosis. Some of~     these patients will require surgery while on dual antiplatelet therapy. This poses a~     challenge because being on Plavix is associated with higher risks of perioperative bleeding,~     but stopping Plavix puts patients at increased risk for in-stent thrombosis.~      Currently, the ACC/AHA guidelines recommend discontinuation of Plavix five days prior to~     surgery to prevent bleeding complications. However, there are no universal recommendations~     for preventing in-stent thrombosis. Some experts recommend the use glycoprotein IIb/IIIa~     inhibitors (short-acting antiplatelet agents) as bridging therapy during the high-risk~     perioperative period. Although these agents should be beneficial based on theory, there is~     currently no published data on their effectiveness for this purpose.~      The current study proposes to evaluate the value of Aggrastat (a short-acting intravenous~     platelet glycoprotein IIb/IIIa inhibitor) in decreasing the risk of in-stent thrombosis~     without increasing the risk of perioperative bleeding.~   "
221952|NCT00653588|"~     The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin~     with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in~     subjects with hypercholesterolemia and coronary heart disease (CHD) or at high risk of CHD..~   "
221953|NCT00653575|"~     This study will evaluate whether childhood experiences are related to current sexual behavior~     of adult women.~   "
221954|NCT00653562|"~     To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography~   "
221955|NCT00653549|"~     To compare the single-dose bioavailability of Torsemide tablets with Demadex~   "
221956|NCT00653536|"~     Patients with acute ischemic stroke and persistent arterial occlusion following failed~     mechanical revascularization, who can undergo NeuroFlo treatment within 18 hours of last time~     symptom free, will be eligible for enrollment to assess the safety and feasibility of the~     NeuroFlo catheter in treating ischemic stroke patients with persistent arterial occlusion~     following attempted thrombectomy. The NeuroFlo catheter is designed to partially obstruct the~     abdominal descending aorta thereby increasing blood flow to the brain. Cerebral perfusion is~     improved by diverting more blood through vessels as well as by expansion of the collateral~     circulation. Improved regional perfusion leads to clinical improvement.~   "
221957|NCT00653523|"~     Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin~     in patients with hypercholesterolemia who have not reached low density lipoprotein~     (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase~     inhibitors.~   "
221958|NCT00653510|"~     The purpose of the study is to characterize the changes in amino acid, lipid and glucose~     metabolism in patients with type 2 diabetes exposed to acute hyperglycemia. Moreover we wish~     to assess the effect of acute hyperglycemia on cardiac output.~   "
221959|NCT00653497|"~     The purpose of this study was to estimate the cost and outcomes of the Arthritis Foundation~     aquatic exercise classes.~        -  DESIGN. Randomized trial of 20-week aquatic classes.~        -  SUBJECTS AND METHODS. Recruited 249 adults from Washington State aged 55 to 75 with a~          doctor-confirmed diagnosis of osteoarthritis~        -  MEAURES. The Quality of Well-Being Scale (QWB), Current Health Desirability Rating~          (CHDR), Health Assessment Questionnaire(HAQ), Center for Epidemiologic~          Studies-Depression Scale (CES-D), Perceived Quality of Life Scale (PQOL)~   "
221960|NCT00653484|"~     RATIONALE: Calories and physical exercise may affect the risk of developing cancer. It is not~     yet known whether a low-calorie diet and/or physical activity program is effective in~     preventing cancer in participants at increased risk of developing colorectal cancer.~      PURPOSE: This randomized clinical trial is studying diet and physical activity in healthy~     overweight, obese, or inactive participants at risk of developing colorectal cancer.~   "
221961|NCT00653471|"~     The purpose of this study is to compare the accuracy of EtPCO2 measurements taken with a~     nasal cannula using the Microcap (Oridion Capnography Inc., Needham, MA) micro-stream device~     and the TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). Three groups of~     non-intubated, spontaneously breathing patients will be included: 1) lean patients without~     obstructive sleep apnea (OSA); 2) obese patients without OSA; and 3) obese patients diagnosed~     with OSA. This latter group has a higher prevalence of oral breathing.~      Additionally, to test the efficacy of oral guides, we propose to compare the accuracy of~     EtPCO2 measurements from the Microcap with two different nasal cannulas, one with (Smart~     CapnoLine PlusTM, Oridion Medical, Jerusalem, Israel) and one without (CapnoLineTM H, Oridion~     Medical) an oral guide to trap gas expired from the mouth. The TG-920 main-stream system~     requires its purpose-designed YG-122T cannula so that is the only one that will be tested~     with the Nihon-Kohden product.~   "
221962|NCT00653458|"~     To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg~   "
221963|NCT00653445|"~     The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared~     with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density~     lipoprotein level goals.~   "
221974|NCT00653302|"~     Primary objective:~        -  Efficacy assessment of the percentage of positive responders patients receiving Lantus~          plus glucophage association. Positive responders patients are defined by a final value~          of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final~          - HbA1c basal).~      Secondary objectives:~        -  Determination of the predictive criterion of HbA1c final,~        -  Determination of the predictive criterion of weight variation,~        -  Description of the glycemic and therapeutic criteria in the both groups of responders~          (positive and negative responders),~        -  Assessment of the lipidic parameters according to the HbA1c and weight changes during~          the study (final value - basal value).~      Safety:~        -  Adverse Event (AE)/Serious Adverse Event (SAE) assessments~   "
221975|NCT00653276|"~     Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of~     a single oral dose cyclosporine in young healthy males and females.~   "
221976|NCT00653263|"~     Methamphetamine use has escalated in recent years. Methamphetamine use has also spread~     throughout the country. Although much information has been gathered on the treatment of~     cocaine abuse, very little information has been obtained on the treatment of methamphetamine~     abuse. One of the first steps in developing appropriate treatment is to examine the effects~     of stopping a particular substance's use on individuals abusing that substance. To date this~     has not been well studied for people abusing methamphetamine. The purpose of this study is to~     better understand and develop accurate ways of measuring symptoms associated with stopping~     the use of methamphetamine in people that are abusing methamphetamine. If the withdrawal~     symptoms are able to be effectively measured, this will help to develop treatments targeted~     at alleviating these symptoms. These symptoms are often associated with relapse to use of~     that substance.~   "
221977|NCT00653250|"~     RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This clinical trial is studying celecoxib in treating patients with stage I, stage~     II, or stage IIIA non-small cell lung cancer.~   "
221978|NCT00653237|"~     We evaluate two new developed airway devices, which provide patent airway during general~     anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a~     difficult airway by using an extrication device collar). We then place consecutively both~     airway devices in the mouth and check for ease of insertion and time used.~   "
221979|NCT00653224|"~     The study objective is to investigate the efficacy of levocetirizine in reducing symptoms~     associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life.~   "
221980|NCT00653198|"~     This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as~     a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised~     children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™~     in the national immunization program.~   "
221981|NCT00653185|"~     The purpose of this study is to determine the efficacy, safety and tolerability of SYR-472,~     once daily (QD), in subjects with Type 2 Diabetes Mellitus.~   "
221982|NCT00653172|"~     The purpose of this study is to compare the efficacy, safety and tolerance of 2 different~     dose levels of oral NXL103 with oral comparator in the treatment of community acquired~     pneumonia in adults~   "
221983|NCT00653159|"~     This is a pilot study to determine the feasibility for a randomized controlled trial of two~     forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the~     Copper T 380A.~   "
221984|NCT00653146|"~     RATIONALE: Mindfulness-based stress reduction (MBSR) may reduce patient stress and improve~     quality of life. It is not yet known whether mindfulness-based stress reduction is effective~     in improving immune response to human papillomavirus in patients with cervical dysplasia.~      PURPOSE: This randomized clinical trial is studying whether mindfulness-based stress~     reduction (MBSR) or a general diet and physical activity program has any effects on immune~     response to human papillomavirus in patients with cervical dysplasia.~   "
221985|NCT00653133|"~     This two tiered study is a multi-center, open label, surveillance study of the use of~     continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound~     guided continuous nerve block techniques. This study was developed to investigate specific~     aspects of complication rates related to continuous nerve block techniques in patients~     undergoing orthopedic surgical procedures.~   "
221986|NCT00653120|"~     To compare the single-dose bioavailability of Propranolol 160 Mg ER capsules with Inderal-La~   "
221987|NCT00653107|"~     We wish to improve the swallowing function of patients with advanced cancer of the~     oesophagus, by carrying out a randomised clinical study in which we compare primary stenting~     followed by brachytherapy in the stent, 8 G x 3 with standard brachytherapy 8 Gy x 3.~      The aim of the study is to investigate whether patients who receive a stent followed by~     brachytherapy have a better swallowing function without more pain at week +2,compared to~     patients who receive brachytherapy alone.~   "
221988|NCT00653094|"~     Today, there is no available equipment specifically designed for the procedure of~     instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment~     involves surgical tools generally used for fistula surgeries, and injection syringes designed~     for general use. The injection of biological adhesives is performed using standard adhesive~     syringes that are not specially designed for use in perianal fistulae. The use of the~     semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating~     an additional path, and the injection syringe and catheter are often inconvenient for~     perianal use. This study was design to test the use of Halevy kit, by gastroenterology~     specialist, as a non traumatic probing, mechanical debridement and injecting or inserting~     device for treatment substances in perianal fistulas. In this study a gastroenterologist will~     perform the procedure, in each procedure a trained colorectal surgeon will be present during~     the surgery to oversee the procedure and to provide surgical help if required.~   "
221989|NCT00653081|"~     The purpose of this study is to compare Supervised Exercises with another non-operative~     frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with~     subacromial impingement syndrome.~   "
222037|NCT00652431|"~     This is a single-center, randomized, open-label, 3-period, 3-treatment multiple-dose~     crossover study designed to assess the interaction between VYTORIN® (Ezetimibe and~     Simvastatin) and NIASPAN® (Niacin Extended-Release Tablets) in healthy subjects. Treatment~     spans 7 days~   "
221990|NCT00653068|"~     This phase III trial is studying giving combination chemotherapy together with 3-dimensional~     conformal radiation therapy and an autologous peripheral blood stem cell transplant to see~     how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the~     central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood~     stem cell transplant stops the growth of cancer cells by stopping them from dividing or~     killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from~     the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation~     therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells~     are then returned to the patient to replace the blood-forming cells that were destroyed by~     the chemotherapy or radiation therapy.~   "
221991|NCT00653055|"~     To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus~     Dostinex (reference)~   "
221992|NCT00653042|"~     The purpose of this study is to assess the effects of nesiritide compared to placebo when~     given with standard of care therapies, on kidney function, heart function and the need of~     other treatments in heart failure patients undergoing heart bypass graft surgery that~     requires the use of a cardiopulmonary bypass machine (CPB pump or heart-lung machine).~   "
221993|NCT00653029|"~     Approximately 1.1 million people a year suffer a mild traumatic brain injury (MTBI), or~     concussion, in the United States. Although most MTBI patients fully recover, as many as 28%~     have physical, cognitive, and/or emotional symptoms up to 6 months post-injury. When symptoms~     persist past three months, it is known as post-concussion syndrome (PCS). The cause of PCS is~     unknown, as structural neuroimaging and neuropsychological (NP) testing results are often~     normal. However, recent functional magnetic resonance imaging (fMRI) research in concussed~     adults showed differences in brain activity compared to controls on working memory tasks,~     despite normal structural MRI and neuropsychological findings. We propose improving this~     research by assessing brain activation patterns during simple versus complex attention and~     working memory tasks in 10 concussed adults via fMRI. This will be the first study to examine~     brain activation patterns associated with the degree of effort applied to testing, a factor~     known to confound interpretation of NP test performance. Validated computerized measures of~     selective attention (Modified Stroop Interference Task), working memory (n-back), and effort~     (Green's Medical Symptom Validity Test; MSVT) will be used. Ten paid controls will be used~     for comparative purposes. We hypothesize that concussed patients will show less brain~     activation than controls on complex versus simple working memory tasks and that activation~     patterns in concussed patients will generally be lower in those with suboptimal effort. We~     will also characterize self-reported emotional and physical symptoms in the PCS patients,~     which has not been done in prior fMRI research with this population.~   "
221994|NCT00653016|"~     The purpose of this study is to document the experience of transdermal contraceptive patch~     over a period of 9 cycles, compared to their previous contraceptive method.~   "
221995|NCT00653003|"~     To compare the single-dose Bioavailability of Kali and Aventis~   "
221996|NCT00652977|"~     The aim of the investigation was to assess whether routine use of the modified Ritgen´s~     maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual~     protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between~     the anus and the coccyx and pulled anteriorly, while using the fingers of the other hand on~     the fetal occiput to control speed of delivery and keep flexion of the fetal neck.~   "
221997|NCT00652964|"~     Detect the PHOX2B Mutation-confirmed congenital central hypoventilation syndrome~   "
221998|NCT00652951|"~     The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal~     conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a~     three-dose primary immunisation course during the first 6 months of life and as a booster~     dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on~     nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two~     years of life will also be assessed. The Protocol Posting has been updated in order to comply~     with the FDA Amendment Act, Sep 2007.~   "
221999|NCT00652938|"~     Infection with human papillomavirus (HPV) has been clearly established as the necessary cause~     of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and~     thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical~     cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent~     vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and~     safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18~     L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.~   "
222000|NCT00652925|"~     To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such~     as pain and swelling.~   "
222001|NCT00652912|"~     To compare the single-dose bioavailability of Clonazepam ODT 1 mg and Klonopin Wafers 1 mg~     ODT~   "
222002|NCT00652899|"~     RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body~     irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells.~     It also helps stop the patient's immune system from rejecting the donor's natural killer~     cells. Aldesleukin may stimulate the natural killer cells to kill ovarian, fallopian tube, or~     primary peritoneal cancer cells. Treating the donor natural killer cells with aldesleukin may~     help the natural killer cells kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving laboratory-treated donor natural~     killer cells together with aldesleukin works when given after cyclophosphamide, fludarabine,~     and total-body irradiation in treating patients with recurrent and/or metastatic ovarian,~     fallopian tube, or primary peritoneal cancer.~   "
222003|NCT00652886|"~     -To compare the single dose bioavailability of Kali and BTG~   "
222004|NCT00652873|"~     To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus~     Dostinex (reference)~   "
222052|NCT00652236|"~     The purpose of the study was to determine the cost-effectiveness of a function-centred~     treatment (FCT) compared with a pain-centred treatment (PCT) in patients with chronic low~     back pain (LBP) in an in-patient setting. Follow-up lasted three years. Direct and indirect~     costs were recorded by questionnaires sent to health insurances, employers and Swiss~     Disability Insurance Company.~   "
222005|NCT00652860|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. GM-CSF may stimulate~     the immune system in different ways and stop tumor cells from growing. GM-CSF, given by~     inhalation, may interfere with the growth of tumor cells and prevent metastases from forming.~     Radiation therapy uses high energy x rays to kill tumor cells. Giving combination~     chemotherapy together with radiation therapy and GM-CSF before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving these~     treatments after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with radiation therapy and GM-CSF before and after surgery works in treating patients with~     stage III soft tissue sarcoma that can be removed by surgery.~   "
222006|NCT00652847|"~     To compare the percent (%) change in plasma LDL-C concentration, after a six week course of~     treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of~     the existing statin dose~   "
222007|NCT00652834|"~     The purpose of this study is to learn more about symptoms and gastrointestinal lesions~     associated with taking myfortic® by switching patients to a delayed release formulation that~     is developed to alleviate GI symptoms. A comparison of the frequency and severity of GI~     symptoms observed in patients treated with MMF (cellcept®) after conversion to myfortic® will~     be measured by using a self-assessed questionnaire called Gastrointestinal Symptom Rating~     Scale (GSRS). To prove the incidence and improvement of GI lesions in patients treated with~     MMF (cellcept®) after conversion to myfortic® will be measured by using Small Bowel Capsule~     Endoscopy (SBCE).~   "
222008|NCT00652821|"~     To compare the relative bioavailability of Kali and Ortho-McNeil's products~   "
222009|NCT00652808|"~     This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was~     at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal~     anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic~     osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and~     tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA~     of the knee.~   "
222010|NCT00652795|"~     To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline~     capsule (Monodox)(Oclassen).~   "
222011|NCT00652782|"~     A study to determine the most appropriate dose of MK7418 in heart failure patients presenting~     with symptoms of volume overload requiring increased diuretic doses.~   "
222012|NCT00652769|"~     In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks),~     costly and inaccurate in up to 20% of cases. The investigators wish to determine whether~     using the newer techniques of endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS)~     improves lung cancer staging. The investigators' hypothesis is that EUS (endoscopic~     ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a~     first test after CT scan in the diagnosis and staging of lung cancer will result in a~     reduction in the time from first outpatient appointment to treatment decision, a reduction in~     the total number of scans and investigative operations, fewer outpatient attendances and a~     reduction in healthcare costs.~   "
222013|NCT00652756|"~     The purpose of this study is to evaluate the use of the VersaMed iVent ventilator in the~     acute care setting, hypothesizing that, in comparison to the standard approach, the use of~     the VersaMed will facilitate transport and reduce transport-associated complications while~     providing equivalent ventilatory support and transport success rates for both intubated~     patients and patients receiving noninvasive ventilation.~   "
222014|NCT00652743|"~     Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus~     found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is~     imminent and could be severe. Prevention and control will depend on the rapid production and~     worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must~     be developed and tested in clinical trials to determine the best formulation and vaccination~     schedule.~      The purpose of this study is to assess the immune response of a candidate pandemic vaccine.~     The protocol posting deals with objectives & outcome measures of the secondary phase of this~     study. The objectives and outcome measures of the primary phase are presented in a separate~     protocol posting (NCT number = 00449670).~   "
222015|NCT00652730|"~     To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl~     Tablets~   "
222016|NCT00652717|"~     Collecting local data, safety and experience trial.~   "
222017|NCT00652704|"~     To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent~     to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)~   "
222018|NCT00652691|"~     RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the~     patient's bone marrow to the blood so they can be collected and stored. Combination~     chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem~     cells are returned to the patient to replace the blood-forming cells that were destroyed by~     the chemotherapy.~      PURPOSE: This randomized trial is studying the side effects and best dose of topotecan when~     given together with high-dose cyclophosphamide, and carboplatin followed by an autologous~     peripheral blood stem cell transplant in treating patients with recurrent ovarian cancer or~     primary peritoneal cancer.~   "
222019|NCT00652678|"~     Some patients who undergo breast cancer treatment with lumpectomy followed by radiation~     therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic~     outcome. The goal of this study is to try to predict severe tissue reactions by using a~     combination of three of the latest blood tests, one of which we have developed ourselves.~   "
222020|NCT00652665|"~     To compare the single-dose Bioavailability of Kali and Aventis~   "
222038|NCT00652418|"~     The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of~     0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three~     regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179~     not assessable: caused by contrast media in the evaluation of structural abnormalities.~     Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with~     arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also~     assessed.~   "
222021|NCT00652652|"~     This is a randomized, open-label, three-way crossover design study with 3 treatment~     groups:TREATMENT A: Furosemide;TREATMENT B: Nesiritide administered IV bolus, followed by an~     infusion for 6 hours;TREATMENT C: Treatment B for at least 15 minutes, then administration of~     treatment AAll sequences involving both furosemide and nesiritide had the nesiritide infusion~     started first, at least 15 minutes before furosemide was administered. Each treatment will be~     administered according to 1 of 6 sequences to which patients are randomized. Patients will~     remain in the Clinical Research Unit for 7 days, with treatments administered on Days 2, 4,~     and 6, with equilibrium (rest) days on Days 1, 3, and 5. All patients will be followed for~     safety throughout the treatment phase, and by telephone between 7 and 14 days after they are~     discharged from the Clinical Research Unit.~   "
222022|NCT00652639|"~     To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1~     mg~   "
222023|NCT00652626|"~     The purpose of this study is to evaluate three things. The first being whether azacitidine is~     absorbed in the body at the same rate or proportion for different concentrations. The second~     is to determine the effect renal impairment has or does not have on the absorption of~     azacitidine. The third is to determine if azacitidine is safe and well tolerated in patients~     with renal function impairment.~   "
222024|NCT00652613|"~     Head & Neck squamous cell carcinomas are the commonest cancers afflicting the developing~     countries. Traditionally surgery or radiotherapy alone in the early stages and surgery with~     postoperative radiotherapy in advanced stages have been the mainstay of treatment. Of late~     there has been a paradigm shift in the management of these cancers, particularly those of the~     oropharynx and laryngopharynx, where chemoradiation has been advocated as part of organ~     preservation protocol with good outcomes. Conventional radiotherapy involves the use of 2 or~     3 field technique with or without compensators to encompass the volume at risk to radical~     doses of 66-70 Gy typically needed to sterilize gross disease. This strategy however is~     associated with considerable acute morbidity (mucositis, dysphagia, dermatitis) and~     debilitating late toxicity (xerostomia). Three dimensional conformal radiation therapy~     (3D-CRT) and intensity modulated radiation therapy (IMRT) have the potential to improve the~     dose distribution, with increased doses to the target volumes and reduced doses to~     surrounding normal structures, thereby improving the therapeutic ratio.~   "
222025|NCT00652600|"~     To compare the single-dose bioavailability of Propranolol 160 Mg ER Capsules with Inderal-La~   "
222026|NCT00652587|"~     The purpose of this study is to evaluate whether hepatectomy combining with adjuvant~     transcatheter arterial chemoembolization (TACE) for Stage IIIA hepatocellular carcinoma (HCC)~     resulting better long-term survival outcome when compared with hepatectomy alone.~   "
222027|NCT00652574|"~     The goal of this clinical research study is to learn how dasatinib affects biomarker levels~     in patients with malignant pleural mesothelioma that may be able to be removed by surgery.~     The safety and effectiveness of this drug will also be studied.~      This research study is financially supported by the United States Department of Defense.~   "
222028|NCT00652561|"~     The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in~     slowing tumor activity in patients with advanced non-small cell lung cancer. The study is~     also looking at the safety of S-1.~   "
222029|NCT00652548|"~     This studies investigates the hypothesis that bedside ultrasound is as accurate as plain~     x-rays for diagnosing clavicle fractures in children in a pediatric emergency department.~     Children with shoulder injuries are enrolled and receive both an ultrasound imaging~     (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or~     better)accuracy, with less cost, time, and radiation.~   "
222030|NCT00652522|"~     It is the purpose of the study to show the benefit of the endocardial catheter ablation by~     pulmonary vein isolation in patients with persistent or longstanding persistent atrial~     fibrillation, low LVEF and requiring ICD or CRT-D therapy compared to the best medical~     treatment with antiarrhythmic drugs.~   "
222031|NCT00652509|"~     Behavior change and self-efficacy are key for patients with diabetes to sustain blood sugar~     goals, but most care systems do not provide effective support to assist patients in~     successful ongoing self-management. After initial education, many programs are limited by~     allowable Medicare reimbursement for diabetes education which currently requires physician~     referral and cannot exceed two hours of training per year for a beneficiary, plus one hour of~     nutritional services. These services are usually provided either on an individual basis or~     occasionally through a traditional group class approach. For patients with established type 2~     diabetes who are not achieving optimal glycemic control, we propose to develop and formally~     evaluate in a randomized trial a novel group experience to educate and motivate patients with~     established type 2 called IDEA, (Interactive Dialogue to Educate and Activate). This~     multi-site, randomized, prospective trial will randomize 621 patients with inadequately blood~     sugar control levels to one of 3 study groups: (1) IDEA - patients receive group sessions~     totaling 8 hours, with an average of 10 patients per group, using conversation maps as a~     conduit to facilitate dialogue between providers and patients (2) Individual Education (IE) -~     patients receive 2 hours with a nurse educator and 1 hour with a dietitian, and (3) Usual~     care (UC)- patients receive no research intervention. The primary analyses will involve mixed~     model regression to assess whether IDEA improves outcomes compared to IE and UC. Blood sugar~     level, blood pressure, and lipids will be evaluated 6 and12 months post-randomization and~     behavioral, emotional, and satisfaction outcomes through survey at baseline, 3, 6, 9 and 12~     months. Depending on 12 month results, a longitudinal four year post intervention analysis is~     planned to assess sustainability of treatment effects and cost-effectiveness.~   "
222032|NCT00652496|"~     This study evaluates the safety and efficacy of different formulations of bimatoprost~     ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or~     ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03%~     given to the fellow eye of each patient~   "
222033|NCT00652483|"~     This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared~     with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension~   "
222034|NCT00652470|"~     The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH)~     have a better long-term outcome at 5 years when they are treated with a new procedure,~     endoscopic third ventriculostomy (ETV), than infants treated with the more traditional~     treatment, insertion of a cerebrospinal fluid (CSF) shunt.~   "
222035|NCT00652457|"~     To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in~     patients with Huntington's disease (HD).~   "
222036|NCT00652444|"~     The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.~   "
226641|NCT00591175|"~     The goal of this study is to see if giving patients information about how smoking affects~     oral health will help them quit smoking. What we learn from this study will help researchers~     find new ways to help smokers.~   "
222039|NCT00652405|"~     Moderate alcohol consumption has consistently been associated with lowered risk of developing~     type two diabetes mellitus compared to abstainers and heavy drinkers. However, the underlying~     mechanism for the lower risk of type two diabetes is not clear.~      Hypothesis: moderate alcohol consumption for four weeks changes gene expression pathways of~     inflammatory status, insulin sensitivity and lipid and carbohydrate metabolism in adipose~     tissue in both lean and obese postmenopausal women.~      Hypothesis: Oral sensory stimulation by means of alcohol in the oral cavity will induce a~     cephalic phase reflex as indicated by increased autonomic & endocrine responses in~     postmenopausal women.~   "
222040|NCT00652392|"~     The purpose of this study is to compare a dose of Symbicort taken once daily with other~     dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in~     adolescents and adults~   "
222041|NCT00652379|"~     The purpose of this study is to investigate if co-treatment of acromegalic patients, who~     beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will~     improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can~     be obtained at a neutral cost as compared to SA mono therapy.~      Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and~     intramyocellular fat.~   "
222042|NCT00652366|"~     This study will compare the efficacy and safety of escalating versus standard doses to rash~     of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer.~     During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus~     gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not~     developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1~     will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2~     weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other~     dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients~     will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle.~     The anticipated time on study treatment is until disease progression, and the target sample~     size is 100-500 individuals.~   "
222043|NCT00652353|"~     The purpose of this study is to evaluate wether the use of a mnemonic strategy could improve~     the recall of the Ottawa Ankle and foot Rules' guidelines among medical students and~     residents~   "
222044|NCT00652340|"~     This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and~     erlotinib as measured by time to disease progression to test the hypothesis that down~     regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor~     will have a clinical benefit compared with erlotinib alone.~   "
222045|NCT00652327|"~     This is a randomized, open label, parallel group comparison study. Following a 1-week~     screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to~     ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of~     10/20, 10/10 or 10/20 mg), or doubling the dose of ongoing statin (simvastatin 40 mg,~     atorvastatin 20 mg, or pravastatin 40 mg). Study drug will be administered once daily in the~     evening for 8 weeks. Patients will be instructed to follow a National Cholesterol Education~     Program (NCEP) or similar cholesterol-lowering dietary regimen throughout the study.~   "
222046|NCT00652314|"~     This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial~     to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat.~      Within this clinical evaluation, Thrombi-Gel will be compared to the current standard of~     care, a gelatin sponge (Gelfoam) plus Thrombin JMI, by using a 2:1 randomization ratio.~     Subjects will be randomized to one of two (2) treatment groups. One (1) group will be treated~     with Thrombi-Gel, while one (1) group will be treated with the gelatin sponge plus thrombin.~     All study data will be analyzed according to the subjects' assigned randomization group~     assignment, regardless of the treatment actually delivered.~   "
222047|NCT00652301|"~     To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and~     simvastatin given alone on intestinal cholesterol absorption.~   "
222048|NCT00652288|"~     The aim of this study is to evaluate the variations in pharmacokinetic and pharmacodynamic~     properties of rapid-acting insulin analogs when given as a bolus by subcutaneous insulin~     infusion pump as typically encountered in the care of children with type 1 diabetes.~      The specific factors under investigation are:~        -  the effects of puberty~        -  type of insulin analog~        -  site of catheter insertion~        -  and age of catheter~   "
222049|NCT00652275|"~     This study will be the fourth time that the candidate malaria vaccine Merozoite Surface~     Protein - long synthetic chain, will be tested in malaria endemic populations.in the~     past,once tested in adults and twice in children proved to be safe in all three occasions for~     this phase IIb study in children to proceed. This study will include children who will be~     randomly allocated to either receive the malaria vaccine adjuvanted with Aluminium Hydroxide~     or the Verorab control. Each participant will receive 3 immunizations, without the clinical~     investigators or the participants themselves knowing what has been given. They will then be~     followed-up for immediate reactions to vaccination, extended safety profile and immunological~     response associated with protection from malaria. These children will be followed up for over~     a longer term of two years. Blood will be taken to evaluate the biological safety parameters~     and also the immune responses.~   "
222050|NCT00652262|"~     BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with~     spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be~     improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not~     sufficiently effective~   "
222051|NCT00652249|"~     The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a~     malfunctioning shunt valve.~      The study will simulate an implanted shunt flow monitoring system by placing the flow sensor~     and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will~     be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting~     up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's~     pressure release settings for each cycle of raising/lowering the bag.~      By monitoring shunt flow during these changes, the doctors hope to develop new ways to~     diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.~   "
226642|NCT00591162|"~     Bone metabolism is adversely affected by severe burns in children for a period of time.~   "
222053|NCT00652223|"~     The purpose of the study is to test the safety, tolerability, immunogenicity and clinical~     efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and~     asthma due to house dust mite allergy in a single-center, open-label setting.~   "
222054|NCT00652210|"~     Multiphoton microscopy (MPM) has been shown to be able to image tissue at a cellular level.~     Our project will initially evaluated the ability of MPM imaging to distinguish normal bladder~     urothelium from atypical and malignant urothelium in the ex vivo setting. After development~     of sufficient criteria, we plan to develop an endoscopic bladder probe that will provide a~     non-invasive means to image the interior of the bladder at the cellular level, which would~     provide direct evidence of the presence of tumor without a biopsy. After exhibiting~     usefulness of MPM imaging for bladder cancer, we will look at other organs beginning with the~     colon.~   "
222055|NCT00652197|"~     The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in~     hydrocephalic shunts.~      The ultrasonic sensor will measure cerebro-spinal fluid drainage in hydrocephalus patients~     with external ventriculostomies and extra-ventricular drainage systems. The sensor~     measurements will be compared with the volume of fluid collected by the drainage bag.~      After a 24-hour measurement period, the doctor will change the drainage bag position to~     simulate the patient sitting up and leaning back, to see if this temporarily stops flow~     through the drainage line.~      This data will show whether the sensor accurately measures typical drainage flows seen in~     hydrocephalus patients. This research will help develop an implantable flow monitor for~     pediatric hydrocephalus patients.~   "
222056|NCT00652184|"~     A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01~     (sorivudine) cream 3%.~   "
222057|NCT00652171|"~     This study reports a clinical trial evaluating lamotrigine safety and efficacy as an~     antidepressant augmentation agent in treatment resistant depression, therefore adding more~     empirical evidence to the limited number of studies on the use of lamotrigine.~   "
222058|NCT00652158|"~     This is a phase 1 clinical trial designed to evaluate increasing durations of MLN8054 oral~     dosing in patients with advanced malignancies. MLN8054 will be given once daily for 4 to 7~     consecutive days per week for 2 to 3 weeks. Following the 2- to 3-week treatment period there~     will be a 2 week recovery period.~   "
222059|NCT00652145|"~     The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin~     (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of~     relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels~     <50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration~     measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All~     patients with persistently elevated FCP will receive one or both of the following~     interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of~     Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the~     primary outcome. The proportion of patients achieving this outcome will be compared between~     groups using Fisher's exact test. All randomized patients as well as those who were excluded~     from the randomized trial because of a low FCP concentration at baseline will be followed to~     week 48 to determine the rate of clinical relapse.~   "
222060|NCT00652132|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Chemoprotective drugs, such as sodium thiosulfate, may protect normal cells from the side~     effects of chemotherapy. It is not yet known whether giving sodium thiosulfate is effective~     in reducing hearing damage caused by cisplatin in treating young patients with liver cancer.~      PURPOSE: This randomized phase III trial is studying how well sodium thiosulfate works to~     decrease hearing loss caused by cisplatin in treating young patients with stage I, stage II,~     or stage III childhood liver cancer.~   "
222061|NCT00652119|"~     The goal of this clinical research study is to learn about the safety and tolerability of~     paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian,~     primary peritoneal, or fallopian tube cancer.~      Objectives:~      Primary study goals:~      To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in~     combination with IV Avastin To determine if Avastin influences the pharmacokinetics of IP~     administered chemotherapeutic agents~      Secondary study goals:~      To determine the systemic exposure to paclitaxel and carboplatin during initial and late~     cycles of IP dosing.~      To collect overall survival (OS) and progression-free survival (PFS) To determine changes in~     IP VEGF levels To determine site of first recurrence Information on CA-125 response and~     clinical response will be descriptive as secondary goals of this study~      Exploratory goal:~      To estimate proportion of patients completing entire course of treatment~   "
222062|NCT00652106|"~     This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed~     combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol~     ophthalmic solutions~   "
222063|NCT00652093|"~     The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone~     hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of~     pain and reducing the severity of pain associated with walking in patients lumbar spinal~     stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is~     defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all~     of one or both legs provoked with walking and standing and relieved by sitting, squatting, or~     forward flexion posturing. The secondary objective is to examine the functional benefit of~     oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to~     improvement in duration and distance of walking.~   "
222064|NCT00652080|"~     The purpose of this study is to determine the safety and tolerability of pharmaceutical~     compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma~     and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell~     carcinoma by Compound 31510 topical cream.~   "
222065|NCT00652067|"~     This protocol is an single patient IND to provide clofazamine to treat one patient who has~     MAI and is resistant to or can not tolerate standard of care. The drug is not otherwise~     available.~   "
222066|NCT00652054|"~     The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in~     slowing tumor activity in patients with metastatic pancreatic cancer who have previously~     received 1st line treatment with a gemcitabine regimen. The study is also looking at the~     safety of S-1.~   "
222067|NCT00652041|"~     Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and~     response duration) and security of a sequential scheme of treatment with Bortezomib in~     combination with Melfalan and Prednisone (V-MP) (patients > 75 years) or Bortezomib and~     Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients <= 75 years) follow~     by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients~     with refractary or relapse multiple myeloma.~   "
222068|NCT00652028|"~     The objective of this study is to characterize the pharmacokinetic and pharmacodynamic~     profile of dexmedetomidine administered as an intravenous loading dose followed by a~     continuous intravenous infusion in pediatric subjects ages ≥2 through <17 years old.~   "
222069|NCT00652015|"~     In-Stent-Thrombosis is a rare but serious complication after implantation of stents during~     PTCA.~   "
222070|NCT00652002|"~     The purpose of this study is to compare Symbicort with budesonide alone and with formoterol~     alone in the treatment of asthma in adolescents and adults~   "
222071|NCT00651989|"~     Optical coherence tomography (OCT) is a well-established and safe technique that offers the~     possibility of visualizing retinal structure and measuring retinal thickness. Time-domain~     (TD)OCT is considered the gold standard technique for retinal thickness measurements.~     Spectral-domain (SD) OCT has to face the gold standard technique prior to obtain scientific~     and clinical consensus.~      In our study in healthy subjects foveal thickness will be measured with both TD and SD OCT ,~     and the data will be compared to evidence any difference between the two retinal measurements~     techniques.~   "
222072|NCT00651976|"~     RATIONALE: Hormone therapy using letrozole may fight breast cancer by lowering the amount of~     estrogen the body makes. Giving letrozole before surgery allows us to monitor the effects of~     letrozole on the tumor on a molecular level and determine markers of response to treatment.~      PURPOSE: This study will show us how well letrozole works in treating postmenopausal women~     with stage I, II or III breast cancer that can be removed by surgery.~   "
222073|NCT00651963|"~     Gather additional efficacy and safety (pharmacovigilance) information in the usual daily care~     in patients with Dyslipidemia on ezetimibe under real conditions in Colombia associated with~     statins.~   "
222074|NCT00651950|"~     The study hypothesis is that nurses and doctors can use a transcutaneously powered ultrasonic~     flow sensor to make repeatable and accurate hydrocephalic shunt flow measurements.~      The study participants will align the flowmeter probe with a flow sensor hidden under a thick~     saline pad that simulates skin. A hidden pump will provide a known flow through the flow~     sensor as the participants make their measurements. Each participant will repeat these~     measurements over a period of weeks, and the data will tell whether operator skill influences~     flow measurement accuracy.~   "
222075|NCT00651937|"~     The goal of this clinical research study is to learn whether higher doses of stem cells can~     help to decrease the symptoms that occur after melphalan. Another goal of the study is to see~     how the dose of infused stem cells affects the levels of certain proteins in your blood.~     Researchers also want to learn how the dose of stem cells that you receive affects the~     quality of your life during the weeks after the transplant procedure.~   "
222076|NCT00651924|"~     This study is designed to develop and test the use of Interactive Voice Response (IVR)~     technology to deliver pain management treatment. IVR allows individuals to receive and~     provide information by using their touchtone telephone. This will allow more people with~     chronic pain to receive treatment even if they are not able to drive to an appointment~     regularly. In the first part of the study, the investigators will develop new materials like~     patient handbooks and pre-recorded explanations about common pain control techniques. In the~     second part of the study, a small number of persons with chronic pain will receive treatment~     using the new materials. We will ask for their feedback about how well they liked using the~     new materials and if the materials are understandable. This will allow us to revise the~     materials if we need to prior to studying them with a larger group of people with chronic~     pain.~   "
222077|NCT00651911|"~     An open-label study to determine the efficacy and safety of Rasburicase used for the~     prevention and treatment of tumor lysis syndrome~   "
222078|NCT00651898|"~     The purpose of this study is to see if the combination of a circulating water mattress~     beneath the patient combined with forced air warming over top of the patient will prevent~     hypothermia (low body temperature) just as well as a garment that circulates warm water~     around the patient, during your major abdominal surgery. Patients will be randomly assigned~     to one of these two groups.~   "
222079|NCT00651885|"~     In chronic CLI patients who are appropriate candidates for endovascular procedures - and many~     patients are not because of their advanced age and disease state - the treatment regimen may~     include endovascular procedures such as percutaneous transluminal endovascular intervention,~     as well as reconstructive surgical procedures such as grafts or bypasses. Amputation is a~     last resort where limb salvage cannot be achieved. Despite the success of percutaneous~     intervention for small coronary vessels with lumen diameters less than 3 mm, similar~     techniques have had limited success in the lower extremity vessels. Infra-popliteal, or below~     the knee endovascular intervention, is commonly plagued by subacute thrombotic closure and~     restenosis in as many as 50% of treated patients. As a result of the limited success, these~     percutaneous procedures have been reserved for the severest cases whereby limb loss is~     imminent without intervention. In this context, the sickest of all patients are enrolled in~     these trials and poor outcomes are common regardless of the intervention. Agents that promote~     intracellular cAMP accumulation, including prostacyclin analogues and phosphodiesterase~     inhibitors, suppress smooth muscle proliferation, promote vasodilatation and inhibit platelet~     aggregation. These properties suggest that prostacyclin analogues such as treprostinil will~     be useful adjuncts to peripheral endovascular intervention and perhaps increase the number of~     patients with CLI that can benefit from peripheral endovascular intervention. An orally~     available prostacyclin analogue could represent an important treatment advance in the~     prevention of restenosis following infrapopliteal angioplasty. In the present study, the~     safety and efficacy of oral UT-15C sustained release (SR) tablets will be compared to placebo~     in patients with CLI undergoing an infra-popliteal endovascular intervention.~   "
222095|NCT00651677|"~     We hypothesize that hand-assisted laparoscopy will overcome technical difficulties related to~     pure laparoscopic rectal surgery and allow surgeons to expand application of laparoscopic~     techniques to treating patients with rectal cancer. In this study, we plan to randomly assign~     patients diagnosed with rectal cancer to undergo either standard laparoscopic surgery or~     hand-assisted laparoscopic surgery. We will then compare both peri-operative and long-term~     outcomes of patients.~   "
222096|NCT00651664|"~     This is a multicenter, dose escalation, phase 1 study of MLN8237 in adult patients with~     advanced malignancies (excluding those with primary bone marrow involvement, such as~     leukemias and multiple myeloma).~   "
222097|NCT00651651|"~     The purpose of this study is to compare Symbicort with its monocomponents budesonide and~     formoterol in the treatment of asthma in children and adults~   "
222080|NCT00651872|"~     This project has the long-term goal of designing and validating a psychometrically sound~     inventory of PTSD-related functional impairment for active duty service members and veterans.~     The inventory will include assessments of multiple dimensions of functional impairment and~     their impact on quality of life and explicitly show how PTSD symptoms are related to~     functional impairment. By creating and validating an inventory to assess PTSD-related~     functioning--as they are perceived and reported by active military personnel and veterans--we~     hope to offer a useful tool for clinicians, researchers and military leaders. A measure of~     PTSD-related functional impairment will have enormous value from a health care perspective in~     terms of identifying individuals with the disorder and for promoting more efficient~     allocation of resources and efforts towards those who are in most need. We anticipate that~     the end product of this study, an efficient, empirically-based measure of PTSD-related~     functional impairment will have an immediate impact on the assessment and treatment of~     military-related PTSD, in terms of promoting more efficient allocation of resources and~     efforts towards those who are in most need. Such a measure will also assist with PTSD-related~     compensation and pension procedures and decisions by providing a means to more accurately~     assess PTSD-related functional impairment.~   "
222081|NCT00651859|"~     This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01%~     ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic~     solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular~     hypertension~   "
222082|NCT00651846|"~     The objective of this study was to investigate the impact of the oral contraceptive YASMIN~     (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral~     contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on~     factors of blood coagulation and fibrinolysis in female subjects~   "
222083|NCT00651833|"~     The purpose of this study is to determine whether S-1 in combination with Cisplatin is~     effective as 1st line therapy in slowing tumor activity in patients with advanced non-small~     cell lung cancer. The study is also looking at the safety of S-1.~   "
222084|NCT00651820|"~     A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6~     and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment~     versus vehicle alone.~   "
222085|NCT00651807|"~     This trial is conducted to evaluate the effect of etonogestrel in comparison to placebo on:~        -  the prostate volume and the urinary complaints;~        -  the urinary flow and the urinary volume in the bladder after voiding;~        -  the progression of the disease;~        -  the sexual function, well-being and urinary complaints-related Quality of Life. In~          addition the safety and the way the drug is absorbed and excreted by the body will be~          analyzed.~   "
222086|NCT00651794|"~     The Neonatal Resuscitation Program (NRP) is the curriculum used to teach providers how to~     care for newborns in the delivery room. Breakdowns in teamwork and communication contribute~     to NRP quality problems. Adding teamwork instruction to NRP may be a method to improve~     communication, teamwork, and the overall quality of neonatal resuscitation. This study uses~     simulation to incorporate team training into NRP and to evaluate both the effectiveness and~     duration of the team training. Furthermore, because high fidelity simulation is very~     expensive and not widely available, we will compare NRP with low fidelity team training to~     NRP with high fidelity team training.~      Our hypotheses are:~        1. NRP with low fidelity team training results in a) better teamwork, and b) better quality~          of care compared with standard NRP.~        2. NRP with high fidelity team training does not result in better teamwork or better~          quality of care than NRP with low fidelity simulation.~        3. NRP with high fidelity team training does not produce a longer lasting effect on~          teamwork than NRP with low fidelity simulation.~   "
222087|NCT00651781|"~     The primary aim of this study is:~      • To analyze the efficacy (in order to evaluate the response) of a sequential treatment~     scheme of Bortezomib in combination with Fludarabine,Cytarabine and Idarubicin continued with~     Bortezomib monotherapy for patients with relapsed or refractory AML ≥18 years old.~      The safety aim of this study is:~      • To evaluate the safety and tolerance of the sequential treatment scheme proposed with~     Bortezomib combined with Fludarabine, Cytarabine and Idarubicin and in monotherapy, measured~     on clinical toxicities and laboratory incidences.~      The biological aim of this study is:~      • To evaluate the Minimal Residual Disease (MRD)impact that will be monitored by~     multiparametric flow cytometry carried out at different moments during the treatment.~   "
222088|NCT00651768|"~     The purpose of this study is to compare the long term safety of Symbicort with budesonide~     alone, in adolescents and adults with asthma.~   "
222089|NCT00651755|"~     The goal of this clinical research study is to learn the effect of combining aprepitant with~     CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed~     or has come back. Researchers also want to see if aprepitant can help to prevent nausea~     and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these~     patients. CHOP consists of four drugs - Cyclophosphamide (also called Cytoxan/Neosar),~     Doxorubicin (or Adriamycin), Vincristine (Oncovin) and Prednisolone while R-CHOP includes~     Rituximab and CHOP.~   "
222090|NCT00651742|"~     The purpose of this study is to determine whether S-1 is effective in slowing tumor activity~     in patients with locally advanced or metastatic pancreatic cancer who have not had~     chemotherapy. The study is also looking at the safety of S-1.~   "
222091|NCT00651729|"~     The purpose of this study is to evaluate the safety of repeated doses of Botulinum Toxin Type~     A for the treatment of focal upper limb poststroke spasticity~   "
222092|NCT00651716|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors predict whether patients undergoing donor stem cell transplant will develop acute~     graft-versus-host disease.~      PURPOSE: This clinical trial is studying T cells to see how well they help in predicting~     acute graft-versus-host disease in patients undergoing donor stem cell transplant.~   "
222093|NCT00651703|"~     The purpose of this study is to evaluate a specific cellular immune response in melanoma~     patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with~     different adjuvants.~   "
222094|NCT00651690|"~     This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A~     treatment in poststroke patients with spasticity of the upper-limb flexors~   "
222099|NCT00651625|"~     The study design is a randomized study to directly compare the performance and the outcome of~     syringe and needle procedures with a standard syringe or the new reciprocating procedure~     device (RDP), which is a type of safety syringe. Over a 5 year period, 820 subjects who~     require and assent to a syringe and needle procedure for their usual and customary care will~     be randomized to either a conventional syringe or the RPD with one arm with and without~     ultrasound guidance. The RPD is designed to be safer, faster, less painful, and more~     effective for the patient, and the mechanics of the RPD are intended to provide the physician~     with better needle control, resulting in less needle trauma to patient tissues, and thus,~     reduced bleeding and pain for the patient. This clinical trial will address whether the RPD~     is indeed superior to the conventional syringe for shots, injections, and needle procedures,~     and whether it is a safer, less painful syringe.~   "
222100|NCT00651612|"~     This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or~     ocular hypertension patients~   "
222101|NCT00651599|"~     Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in~     Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and~     tolerability of Angeliq.~   "
222102|NCT00651586|"~     This study evaluates the safety and efficacy of gatifloxacin 0.3% ophthalmic solution~     compared with ciprofloxacin 0.3% ophthalmic solution in patients with acute bacterial corneal~     ulcers~   "
222103|NCT00651573|"~     The primary purpose of this study is to determine the best blood level to begin transfusing~     red blood cells in individuals undergoing cardiac surgery.~      The secondary aim is to determine the impact of red cell transfusion on health-related~     quality of life following surgery.~   "
222104|NCT00651560|"~     This study is intended to allow physicians to check the superior clinical efficacy of Vytorin~     compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement~     and cardiovascular risk reduction in adult patients with dislipidemia.~   "
222105|NCT00651547|"~     The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone~     in the treatment of asthma in children aged 6 to 11 years~   "
222106|NCT00651534|"~     This study will examine the effects of formulation on the relative bioavailability of~     SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a~     single oral dose of each formulation, with five formulations of SB-751689 tested in total.~     Blood samples will be taken up to 24 hours postdose after each dose administration. This~     study will provide information for future possible formulation development of SB-751689 for~     Phase III.~   "
222107|NCT00651521|"~     The prevalence and mortality rate of cardiovascular disease (CVD) in chronic kidney disease~     (CKD) patients is high. The prevalence of coronary artery disease (CAD) in CKD population~     ranges from 38 to 65%, with an average of 3.3 coronary lesions per person. The relative risk~     for death from myocardial infarction and CAD is 1.18 in CKD patients with GFR < 60 ml/min.~     Because of this high prevalence of CAD and its high mortality, reducing and preventing CAD~     risk factors is crucial in the clinical management of CKD patients.~      Low glomerular filtration rate (GFR) constitutes an important independent risk factor for~     CAD. Several pathogenic factors play role in the genesis of cardiovascular dysfunction in~     chronic kidney disease. Increased traditional CAD risk factor, endothelial dysfunction,~     sympathetic hyperactivity, renin-angiotensin system activation, increased glycosylated end~     products, all contribute to the characteristic medial calcification of cardiovascular disease~     in CKD patients. Hypertension, fluid overloading and anemia further aggravated the cardiac~     loading, leading to myocardial hypertrophy with chamber dilatation, heart failure and death.~      The mortality rate of CAD in CKD patients is extremely high. The NHANES II (National Health~     and Nutritional Evaluation Survey) found an increased of mortality rate> 51%, when the GFR~     decreased from > 90 to < 70 ml/min. The 1-year mortality rate in different CKD stage were~     0.7% (normal renal function patients), 2.0% (patients with proteinuria), 3.5% (overt~     proteinuric patients) and 12.1% (dialysis patients), respectively. However, the clinical~     feature and outcome of CAD in different stage of CKD remains unclear.~      We conducted a retrospective cohort study involving all patients admitted for coronary~     angiography from 1992 to 2004. The patients were categorized into five stages of CAD to~     compare the risk factor, clinical feature and outcome. Determination of this relationship can~     help to establish factors for early detection of CAD in CKD patients and also prognostic~     factor to improve outcome of these patients.~   "
222108|NCT00651508|"~     The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a~     single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following~     initial chemotherapy.~   "
222109|NCT00651495|"~     Chronic diseases are the primary cause of morbidity and mortality for older Americans. Active~     patient participation in treatment decision-making has the potential to significantly improve~     outcomes in chronic disease care, but interventions to increase participation remain~     underused. Some studies have found that older individuals are less interested in~     participating in clinical decision-making, but other studies find that exposing patients to~     decision aids (PtDAs) increases their desire to take an active role in making decisions with~     their physicians. The present study targets hard-to-reach seniors by showing decision aids~     focused on chronic disease management in senior centers. Decision aids will be made available~     in two senior centers through a lending library and by conducting group screenings of the~     decision aids followed by moderated discussion of the content with participants. A randomized~     encouragement design will be used to test the effectiveness of a modest financial incentive~     on increasing seniors' participation in group screenings. The investigators will evaluate the~     effects of the intervention on seniors' decision-making role preferences, attitudes,~     perceived social norms and self efficacy for asking questions of their physician,~     health-related quality of life, physical activity, and changes in prescribed treatment~     regimens and self-care.~   "
222110|NCT00651482|"~     To determine the safety and efficacy of the combination of bevacizumab and everolimus~     (RAD001) for the treatment of metastatic renal cell cancer~   "
222111|NCT00651469|"~     The objectives of this study were to evaluate the efficacy and safety of drospirenone 3~     mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with~     moderate acne vulgaris during 6 treatment cycles.~   "
222112|NCT00651456|"~     Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of~     MPM will improve overall survival and quality of life beyond that achieved with chemotherapy~     alone.~   "
222113|NCT00651443|"~     The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects~     with previously untreated follicular NHL.~   "
222145|NCT00651027|"~     The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that~     hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to~     determine the impact of varying degrees of hepatic impairment on the pharmacokinetics, safety~     and toleration of 200 mg PF-00868554 administered as a single-dose.~   "
222114|NCT00651430|"~     Adults suffer from Osteoarthrosis of hip joint that willing to participate in the study will~     be tested with well-established measuring techniques of Balance control using force plate~     before 3 month and 6 month after Total Knee Arthroplasty (THA) in the movement and~     Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized~     stabilogram-diffusion parameters from each of the COP data sets collected during quiet~     standing. These parameters include diffusion coefficients, critical displacement, critical~     time and scaling exponents for both lateral and anterior-posterior sway directions (Collins &~     De Luca, 1993). Each of the Times (before 3 month and 6 month after the THA) in two task~     conditions (eyes closed and eyes close conditions). Participants will be required to stand on~     the platform 10 times for 30 s For each trial, they will be instructed to sway as little as~     possible. In addition step execution test and Late life function and disability~     questionnaires will be also examined.~   "
222115|NCT00651417|"~     Participants will be diagnosed with localized prostate or breast cancer and be scheduled to~     undergo external beam radiation therapy. Participants will either receive a placebo or~     organic germanium to be taken 5 times a day starting the day of their first radiation and~     continuing through the 1 month follow-up visit. Weekly Quality of life forms will be~     completed through the one month follow up visit and then at the 3 month follow up visit. Labs~     will be done prior to the start of treatment, at the end of treatment and at the one and~     three month follow-up visits.~   "
222116|NCT00651404|"~     To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin~     10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg~     daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of~     treatment.~   "
222117|NCT00651391|"~     The purpose of this study is to evaluate the effect of ezetimibe coadministered with~     simvastatin compared with simvastatin alone when administered for 12 weeks on endothelial~     function as assessed by brachial artery reactivity testing (BART) using high-frequency~     ultrasound to image the brachial artery vasomotor response to a flow-mediated stimulus~     (high-shear stress) in subjects with high cholesterol. The secondary objectives include~     evaluation of nitroglycerin-induced vasodilation. In addition, lipid parameters~     (low-density-lipoprotein cholesterol [LDL-C], high-density-lipoprotein cholesterol [HDL-C],~     triglycerides [TG], total cholesterol [TC]) and C reactive protein (CRP) will be assessed by~     treatment group.~   "
222118|NCT00651378|"~     This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin~     10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d~     or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal~     LDL-cholesterol of <2.5 mmol/L. Treatment phase is 6 weeks.~   "
222119|NCT00651365|"~     This purpose of the study is to determine what dose of JNJ-38877605 is safe and if~     JNJ-38877605 has any effect in patients with advanced or refractory solid tumors for which~     there are not alternative therapies.~   "
222120|NCT00651352|"~     Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated~     with a single dose or four study treatments in a randomized sequence.~   "
222121|NCT00651339|"~     Children suffer from Cerebral Palsy that willing to participate in the study will be tested~     with well-established measuring techniques of Balance control using force plate before 2~     month after BOTOX injection in the movement and Rehabilitation Laboratory at BGU. An~     automated algorithm will be used to extract standardized stabilogram-diffusion parameters~     from each of the COP data sets collected during quiet standing. These parameters include~     diffusion coefficients, critical displacement, critical time and scaling exponents for both~     lateral and anterior-posterior sway directions (Collins & De Luca, 1993). Each of the Times~     (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close~     conditions). Participants will be required to stand on the platform 5 times for 30 s For each~     trial, they will be instructed to sway as little as possible. In addition Gait analysis will~     be also examined.~   "
222122|NCT00651326|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such~     as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of~     androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet~     known whether giving androgen suppression therapy together with radiation therapy is more~     effective with or without docetaxel in treating prostate cancer.~      PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation~     therapy, and docetaxel to see how well they work compared with androgen suppression therapy~     and radiation therapy in treating patients with high-risk localized prostate cancer.~      CLOSURE: This trial closed to further accrual in November 2009. The study endpoints will not~     be reached.~   "
222123|NCT00651313|"~     The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective~     for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared~     to placebo (inactive gel).~   "
222124|NCT00651300|"~     The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal~     surgery. Morphine intake is compared between patients on placebo and patients on~     parecoxib/valdecoxib.~   "
222125|NCT00651287|"~     The purpose of this study is to determine the response rate for the therapeutic goal~     (diastolic blood pressure (BP) less than 90 mmHg and systolic BP less than 140 mmHg) at Week~     6 for quinapril 20 mg and at Week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20~     mg plus hydrochlorothiazide 12.5 mg; and to determine the mean decrease in diastolic and~     systolic BP measurements and the change in heart rate at Week 6 and Week 12 compared with~     baseline.~   "
222126|NCT00651274|"~     This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing~     treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg~     alone in further reducing LDL-C concentrations.~   "
222146|NCT00651014|"~     The study was designed to assess whether 6 weeks of co-administration of ezetimibe and~     simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD~     risk strata of the NCEP III guidelines to achieve their LDL-C target goal of <=3.0 mmol/L. As~     this study was to be conducted in Canada, the target LDL-C goal for patients with CHD, or~     type II diabetic patients >30 years old with no CHD, was <2.5 mmol/L.~   "
222127|NCT00651261|"~     The purpose of this study is to compare the effects, good and/or bad, of a standard~     chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined~     with or without midostaurin (also known as PKC412), to find out which is better. This~     research is being done because it is unknown whether the addition of midostaurin to~     chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been~     tested in over 400 patients and is being studied in a number of illnesses, including AML,~     colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as~     FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells~     will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells~     with the abnormal FLT3 gene.~   "
222128|NCT00651248|"~     The purpose of this study is to identify the relation of the salivary flow and the buffer~     capacity of the saliva with medicine, buccal discomfort and auto-related illnesses in aged~     people.~   "
222129|NCT00651235|"~     To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive~     dilation of aortic root in patients with Marfan syndrome.~   "
222130|NCT00651222|"~     The purpose of this study is to review cause of death in patients undergoing prostate~     brachytherapy at a single institution. Furthermore, we are analyzing patients undergoing~     androgen deprivation therapy and whether or not this contributed to cardiovascular deaths,~     specifically myocardial infarction.~   "
222131|NCT00651209|"~     This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an~     option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve~     HBV DNA non-detectability.~   "
222132|NCT00651196|"~     An increased skeletal fracture risk in diabetes has only recently been recognized. This human~     study is designed to elucidate the effect of Type 1 diabetes on bone remodeling and on~     structure.~   "
222133|NCT00651183|"~     The objective of this PMS study is the evaluation of depressive symptoms measured with~     Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and~     with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole~     treatment in early and advanced PD patients. In addition it will be investigated whether~     improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part~     III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80~     specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be~     taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule~     independently of food intake) and can be titrated upwards, as required, at weekly intervals~     to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics~     (SPC).~   "
222134|NCT00651170|"~     Median nerve block is widely practised, avoiding general anaesthesia in a number of cases and~     producing excellent post-operative analgesia in orthopedic surgery. Even realised by~     experienced anaesthetists,a failure rate of 5-15% is noticed. The principal aim of the study~     is to observe the local anesthetic solution diffusion after a conventional median nerve block~     technique using neurostimulation. The secondary objective is to compare diffusion and of~     block efficacy..~   "
222135|NCT00651157|"~     This phase II trial is studying the side effects and how well viral therapy works in treating~     patients with metastatic melanoma. Viral therapy may be able to kill tumor cells without~     damaging normal cells.~   "
222136|NCT00651144|"~     The purpose of this study is to obtain data of the coadministration of ezetimibe and~     rosuvastatin to support the concomitant use of these two drugs in patients requiring~     additional cholesterol-lowering management. Treatment is administered for 14 days.~   "
222137|NCT00651131|"~     The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients~     with superficial and deep post-surgical Gram-positive wound infections~   "
222138|NCT00651118|"~     The purpose of this study is to determine if two allergy medications (azelastine and~     fluticasone) are more effective than placebo or either medication alone (azelastine or~     fluticasone)~   "
222139|NCT00651105|"~     The purpose of this study is to assess the GLP-1 and non-GLP-1 effects of LAF237 on glucagon~     secretion, using treatment observations of the overall glycemic response.~   "
222140|NCT00651092|"~     The aim of the study is to compare endoscopic submucosal inferior turbinectomy to blunt~     turbinectomy in terms of subjective and objective parameters.~   "
222141|NCT00651079|"~     To determine safety, tolerability and Pharmacokinetics of GSK1247303~   "
222142|NCT00651066|"~     The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin~     (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an~     alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic~     induction effect appears to be less important on the associated antiretroviral therapy (ART)~     drugs.~      This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in~     combination with different ART regimens in Vietnamese HIV infected patients with pulmonary~     tuberculosis, in order to define optimal doses that will be further tested in a larger phase~     III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.~   "
222143|NCT00651053|"~     This is a investigator-initiated, single-center, prospective study to evaluate endoscopic~     ultrasound (EUS) as a diagnostic test for chronic pancreatitis (CP). EUS detects~     abnormalities of the pancreas that may represent scarring from CP. The validation of any new~     test requires a comparison with the best available reference standards. There is no true~     gold standard for diagnosis of CP; however, pancreatic function testing (PFT) is highly~     sensitive for exocrine dysfunction as a surrogate for early fibrosis, and is widely~     considered the non-histologic gold standard. There are no well-designed prospective studies~     comparing EUS with PFT as reference standard.~      EUS detects parenchymal and ductal features of CP said to correlate with fibrosis. We~     hypothesize that a predominance of parenchymal fibrosis results in diminished acinar-cell~     secretion of enzymes. Conversely, a predominance of ductal fibrosis results in impairment of~     ductal secretion of bicarbonate. Because secretin and cholecystokinin (CCK) PFTs measure~     unique aspects of pancreatic function (duct-cell and acinar-cell function, respectively), the~     use of both hormonal stimulants will allow the most comprehensive investigation of the~     significance of EUS features. There are no studies comparing EUS with combined or dual~     performance of secretin and CCK PFTs.~      The primary objective of this study is to determine the test characteristics of EUS for~     diagnosis of CP compared with dual secretin- and CCK- stimulated PFTs as reference standard.~     Secondary objectives include to: 1. Determine the optimal number and relative functional~     importance of specific EUS criteria, 2. Compare the test characteristics of linear- and~     radial-array EUS.~      190 patients evaluated for pancreatitis or pancreatic-type abdominal pain will undergo the~     new test (radial and linear EUS) and the reference standard (CCK and secretin PFTs). The~     EUS examinations will be videotaped and interpreted in a blinded fashion. EUS scores will be~     compared with PFT results to allow the calculation of sensitivity and specificity of linear~     and radial EUS. Receiver operating characteristics (ROC) analysis will be used to determine~     the optimal number of EUS criteria for diagnosis.~   "
222144|NCT00651040|"~     Therapeutical trial in patients with idiopathic polymyositis (PM) and dermatomyositis (DM) is~     proposed. The study will investigate the safety and efficacy of combined methotrexate (MTX) +~     glucocorticoids (GC) treatment compared with GC alone.~      This will be a randomised, open-label, assessor-blind, international multicenter trial,~     performed in several European centres interested in research on inflammatory myopathies~     (IIM).~      A total number of 50 patients with PM/DM will be randomised into two groups (1: MTX+ GC and~     2: GC only). Patients will be equally distributed between the two groups providing 25~     patients per treatment arm. The randomisation will be based on random numbers generated by a~     computer program. After being enrolled in the study, the patients will receive 12 months of~     therapy followed by a 12-month follow-up period.~      The primary endpoint is the total dose of GC ( in mg/kg weight), which will be administered~     for 12 months between baseline and the end of treatment.~      There are several of secondary objectives, which will be pursued during and after the trial.~     Disease activity and damage will be prospectively assessed by tools for myositis disease~     activity (MYOACT and MITAX) and for myositis damage (MYODAM and MDI), global assessment of~     activity and damage by patients and by physician, muscle endurance, muscle strength by manual~     muscle testing, enzyme levels, GC related side effects, functional ability measured by HAQ,~     quality of life by SF-36, and number of patients with treatment failures. The other aims will~     also include (i) search for reliable prognostic parameters in the further prognosis of~     patients with PM/DM and (ii) studies on the pathogenic aspects of IIM. The investigations of~     serum, lymphocytes, muscle tissue and MRI will be organized. DNA and RNA will be stored for~     future genetic studies.~      Patients with definite or probable PM or DM diagnosed according to diagnostic criteria will~     be enrolled. They will have disease activity that according to physician's own judgement~     requires high dose immunosuppressive treatment (based on clinical assessment of weakness,~     elevation of muscle enzymes and, if available, on magnetic resonance imaging findings).~     Patients should be previously untreated with the exception of GC treatment up to 8 weeks.~      Patients with other than primary idiopathic PM or DM, such as drug-induced myositis, myositis~     in association with other connective tissue disease, inclusion body myositis, malignancy~     related myositis, and juvenile DM will be excluded.~      All patients will start with prednisone 1 mg/kg/day and the dose will be tapered if patients~     meet definition of improvement, which has been proposed by IMACS group. MTX will be~     administered orally, once weekly, with a starting dose 10 mg. This will be increased~     gradually to 25 mg/week if tolerated by week 5. Patients will be first assessed after 2 weeks~     and than monthly for a period of 48 weeks. There will be a follow-up after a further 1 year~     in order to find out the impact of the early treatment on the long-term disease outcome.~      All efficacy analyses will be performed using intention-to-treat population (ITT). In~     addition, the primary and secondary variables will be analysed using the per-protocol~     population, which will contain all patients in the ITT population, who also reached Week 48~     without any major protocol violations. The safety population, which will contain any patient~     who received at least one dose of study drug, will be used for all safety analyses.~   "
222147|NCT00651001|"~     A Food Frequency Questionnaire (FFQ), will be provided to 800 adults to assess overall~     fructose intake and this will be related to a number of features related to the metabolic~     syndrome, including serum leptin, characteristic features of metabolic syndrome (body mass~     index, waist circumference, plasma lipids, blood pressure, HOMA index,fasting glucose and~     fasting insulin levels) and other as: CRP, fibrinogen, homocysteine and uric acid.~   "
222148|NCT00650988|"~     This is a single center study to evaluate the efficacy and safety of a new ablation technique~     involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper~     endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or~     intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal~     wall, in whom there are no standard treatment options available.~   "
222149|NCT00650975|"~     1. Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related~          artery (IRA) stenting results in improved reperfusion success in patients presenting~          with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident~          thrombus.~        2. Validate an ELCA technique for the treatment of STEMI, at high-volume centers~          experienced in the treatment of acute myocardial infarction (AMI).~   "
222150|NCT00650962|"~     1. Pre-shock cardiopulmonary resuscitation might benefit the survival of out-of-hospital~          cardiac patients with ventricular fibrillation / ventricular tachycardia in a post-hoc~          analysis of a prehospital trial conducted in Europe (L.Wik,2002). However, it's~          effectiveness in the Asian countries, where most firstly recorded rhythm in~          out-of-hospital cardiac arrests patients were asystole/pulseless electric activity~          rather than ventricular fibrillation / ventricular tachycardia, were not explored yet.~        2. This trial was designed to exam if pre-shock cardiopulmonary resuscitation by emergency~          medical technicians improves the outcome of all out-of-hospital cardiac arrest patients~          in an Asian metropolitan city.~   "
222151|NCT00650949|"~     This study seeks to (i) determine the safe dose of CYT997 when given in combination with~     carboplatin in patients with relapsed glioblastoma multiforme (glioma) and (ii) to determine~     whether the combination of CYT997 with carboplatin is a useful treatment for glioma.~   "
222152|NCT00650936|"~     The purpose of this study is to prospectively evaluate the incidence of hemodynamic~     compromise and to obtain long-term survival data on patients with the AMPLATZER Septal~     Occluder~   "
222153|NCT00650923|"~     This phase I trial is studying the side effects and best dose of aflibercept when given~     together with radiation therapy and temozolomide in treating patients with newly diagnosed or~     recurrent glioblastoma multiforme, gliosarcoma, or other malignant glioma. Aflibercept may~     stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving aflibercept together with radiation therapy and~     temozolomide may kill more tumor cells.~   "
222154|NCT00650910|"~     This is a two part study looking at the effect of lapatinib on concentrations of digoxin in~     the blood when both drugs are dosed together in Part 1; and looking at the safety and~     antitumor effect of lapatinib when used together with possible additional anticancer therapy~     as chosen at the doctor's discretion.~   "
222155|NCT00650897|"~     Patients with diabetes and major depression treated with Escitalopram might experience~     significant improvement in depression and anxiety scores; functional ability;~     diabetes-related self-care; and pain symptoms~   "
222156|NCT00650884|"~     The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is~     effective in reducing pain from Plantar Fasciitis (Fasciopathy).~   "
222157|NCT00650871|"~     A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects~     participate in a clinical screening visit and a two-night PSG recording session in the sleep~     laboratory. Eligible subjects then participate in three separate two-night PSG sessions in~     which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior~     to bedtime, one treatment for each session in a balanced order. Each treatment session is~     separated by a two-week drug-free period and occur on the same day of the week. A safety~     follow-up visit occurs 2 weeks after the last treatment session.~   "
222158|NCT00650858|"~     The specific objective of this trial is to determine the lowest dose and dose frequency~     possible with the best pharmacokinetic and safety profile and it's ability to remove a blood~     clot from the ventricular system.~   "
222159|NCT00650845|"~     Although there is a well documented risk of acute renal failure with the iodinated contrast~     agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity~     remains controversial. The aim of this study was to evaluate the safety profile of gadoterate~     meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of~     patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate~     meglumine.~   "
222160|NCT00650832|"~     The purpose of this study is to determine the antiviral activity, safety and tolerability of~     TMC114, formulated as an oral tablet, and administered with a low dose of ritonavir~   "
222161|NCT00650819|"~     This is a multicenter, randomized, double blind; active-controlled parallel groups study~     enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe,~     simvastatin, or the combination once daily for 8 weeks to determine the effect on~     LDL-cholesterol.~   "
222162|NCT00650806|"~     The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in~     promoting weight loss in patients who are overweight or obese and who do not have diabetes.~   "
222163|NCT00650793|"~     The purpose of the study was an Open Label Extension to a completed study that evaluated the~     efficacy and safety of 3 fixed dosages of Extended Release OROSÂ® Paliperidone~   "
222164|NCT00650780|"~     We have just completed a randomized, clinical trial of 100,000 IU Vitamin D3 given as a~     single dose at the beginning of winter. We found a wide range of responses to the dose. This~     study proposes that genetic differences account for some of the variation in response of~     25(OH)D levels after treatment with oral Vitamin D.~   "
222200|NCT00650312|"~     The objective of this study is to investigate the bioequivalence of Mylan metformin~     hydrochloride ER tablets to Glucophage® XR tablets following a single, oral 500 mg (1 x 500~     mg) dose administration under fasting conditions.~   "
222165|NCT00650767|"~     This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the~     effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in~     patients on stable doses of methotrexate, and to further evaluate the safety of the study~     drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and~     Romania will be enrolled in this study.~   "
222166|NCT00650754|"~     The experimental focus of this project is on the interaction of DHEA treatment on pregnancy~     in women with otherwise unexplained infertility and evidence of premature ovarian aging~     (POA).~   "
222167|NCT00650741|"~     The purpose of the study is to investigate the sensitivity and specificity of the Endotect~     compared with an ultrasound device in a flow-mediated vasodilatation (FMD) test.~   "
222168|NCT00650728|"~     As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left~     atrium may damage the esophagus and create esophageal perforations and esophageal left atrial~     fistula. The aim of the present study is to compare different methods for visualization of~     the esophagus to prevent this complication.~   "
222169|NCT00650715|"~     The purpose of this study was to investigate the acute and chronic effect of whole-body~     vibration exercise on serum insulin-like growth factor-1 levels in women with fibromyalgia~     (FM). It was hypothesized that women with FM would exhibit an increase in IGF-1 following~     both acute and chronic WBV. Twenty-four women with FM were randomized into two groups:~     Vibration Group (VG) and Control Group (CG). The VG underwent a protocol with WBV exercise~     twice a week for a total of six weeks, whereas the CG performed the same protocol without~     vibratory stimulus. Both groups continued with their usual pharmacological treatment. Serum~     IGF-1 levels were determined using Enzyme-Linked Immunosorbent Assay (ELISA). To test the~     effect of chronic WBV, serum IGF-1 measurements were taken at baseline and at weeks 1,3, and~     6 of intervention. To test the effect of acute WBV, within week 1, serum IGF-1 measurements~     were taken before and immediately following a session of WBV.~   "
222170|NCT00650702|"~     The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe~     and effective in controlling intraocular pressure in patients with open-angle glaucoma or~     ocular hypertension.~   "
222171|NCT00650689|"~     The primary objective is to evaluate the efficacy and safety of coadministration of ezetimibe~     10 mg with atorvastatin 10 mg in untreated subjects with primary hypercholesterolemia and~     coronary heart disease for whom diet and exercise have failed. The primary variable is~     LDL-cholesterol (LDL-C), and the secondary variable is total cholesterol (TC), HDL-C, and~     triglycerides (TG). The following variables were used to assess the safety and compliance of~     the drug: vital signs and laboratory values. Variables were measured before the first~     administration of the drug and at the last administration of the drug, after 6 weeks of~     treatment. Adverse events were also assessed.~   "
222172|NCT00650676|"~     Blind Adults that willing to participate in the study will be tested with well-established~     measuring techniques of Balance control using force plate in the movement and Rehabilitation~     Laboratory at Ben-Gurion University. An automated algorithm will be used to extract~     standardized stabilogram-diffusion parameters from each of the COP data sets collected during~     quiet standing. These parameters include diffusion coefficients, critical displacement,~     critical time and scaling exponents for both lateral and anterior-posterior sway directions~     (Collins & De Luca, 1993). the subjects will be tested in 3 task conditions (eyes~     blindfolded, eyes blindfolded holding stick, eyes blindfolded holding a dog). Participants~     will be required to stand on the platform 10 times for 30 s For each trial, they will be~     instructed to sway as little as possible.~   "
222173|NCT00650663|"~     The purpose of this study is to evaluate whether coadministration of ezetimibe 10 mg/day with~     simvastatin 20 mg/day for 12 weeks will result in greater reduction of LDL-C, total~     cholesterol (TC), triglycerides (TG), non HDL-C, and apolipoprotein B (ApoB), and greater~     increase in HDL-C, compared with simvastatin 20 mg/day as monotherapy for 12 weeks in~     African-American subjects with primary hypercholesterolemia. This study is being performed to~     better define the efficacy of ezetimibe coadministered with simvastatin in this population.~   "
222174|NCT00650650|"~     The standard imaging procedure to diagnose a nasal fracture still is radiography (lateral~     nasal view and occipitomental view). But technological advances in ultrasonography during the~     last few decades have made high-resolution ultrasound devices available to the majority of~     medical centers. It has been shown that the bony structures of the nose can be well examined~     by ultrasound in the last few years. The hypothesis: Is ultrasound of equal diagnostic~     accuracy in diagnosing nasal fractures as radiography is being tested in the investigators'~     study. Patients with suspected nasal fracture undergo ultrasound examination in addition to~     the routine x-ray imaging. After completion of treatment, the readings of both ultrasound and~     radiographs are compared in terms of sensitivity and specificity to diagnose nasal fractures.~   "
222175|NCT00650637|"~     The purpose of this study was to determine the efficacy and safety of calcium carbonate for~     the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of~     calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated~     diarrhea.~   "
222176|NCT00650624|"~     To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three~     dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and~     symptoms of osteoarthritis of the knee. To assess safety and tolerability of multiple doses~     of valdecoxib in patients with osteoarthritis of the knee.~   "
222177|NCT00650611|"~     The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in~     children and teens with psychotic disorders~   "
222178|NCT00650598|"~     To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading~     dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac~     sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee~     arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered~     for 6 (±1) days.~   "
222179|NCT00650585|"~     The purpose of this study is to replicate a longitudinal evaluation of Project ALERT, a~     substance abuse prevention program that targets middle school students.~   "
222201|NCT00650299|"~     The objective of this study was to investigate the bioequivalence of Mylan's alprazolam~     Extended-release 3 mg tablets to Pharmacia & Upjohn's Xanax XR® 3 mg tablets following a~     single, oral 3 mg (1 x 3 mg) dose administered under fed conditions.~   "
222180|NCT00650572|"~     This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+~     metastatic breast cancer will receive investigational study drug ARRY-380.~      This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies,~     who have already received at least one previous standard therapy, will receive increasing~     doses of study drug in order to achieve the highest dose of study drug possible that will not~     cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in~     Part 1 (Completed).~      In the second part of this study, patients with HER2+ metastatic breast cancer, who have~     already received at least one previous standard therapy, will receive the best dose of study~     drug determined from the first part of the study and will be followed to see what side~     effects and effectiveness the study drug has, if any, in treating the cancer. Approximately~     20 patients from the US will be enrolled in Part 2 (Active, not recruiting).~   "
222181|NCT00650559|"~     There is a growing population of end-stage COPD patients for whom surgical treatments like~     lung transplantation and lung volume reduction surgery are not possible. In such patients,~     size mismatch between large emphysematous lungs and a restricted chest wall is a major cause~     for the reduction of dynamic lung volumes and consequent dyspnea. We hypothesized that~     enlargement of the thorax would be a potential alternative strategy to volume reduction~     surgery as it may improve lung mechanics by resizing the chest to the lung and does not~     further deprive patients from lung tissue which is already scarce.~   "
222182|NCT00650546|"~     We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28~     weeks improves liver histology in diabetic patients with biopsy-proven NASH.~   "
222183|NCT00650533|"~     The objective of this study was to investigate the bioequivalence of Mylan's glimepiride 1 mg~     tablets to Aventis Amaryl® 1 mg tablets following a single, oral 1 mg (1 x 1 mg) dose~     administered under fed conditions.~   "
222184|NCT00650520|"~     The objective of this study is to assess the single-dose relative bioavailability of Mylan~     Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg~     bromocriptine mesylate tablets, following the administration of a 10 mg dose, under fed~     conditions.~   "
222185|NCT00650507|"~     This study will be the first large scale randomized study of remote ischemic preconditioning~     (RIPC) ever performed and will define the role of this novel therapy as a clinical tool. This~     study will also be the first to define preoperative gene expression profiles associated with~     poor postoperative outcomes in a control (SHAM) population of children undergoing cardiac~     surgery. Finally, the role of RIPC in modifying these gene expression profiles will be~     examined. Therefore, mechanistic insight into the proven ability of RIPC to improve markers~     of tissue injury, and the expected improvement in clinically relevant endpoints, will be~     examined.~   "
222186|NCT00650494|"~     The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir~     hydrochloride 1000 mg tablets to GSK's Valtrex® 1000 mg tablets following a single, oral 1000~     mg (1 x 1000 mg) dose administration under fed conditions.~   "
222187|NCT00650481|"~     The objective of this study was to investigate the single-dose relative bioavailability of~     Mylan's oxybutynin chloride Extended-release tablets to ALZA's Ditropan XL® tablets following~     a single, oral 20 mg (4 x 5 mg) dose under fasting conditions.~   "
222188|NCT00650468|"~     A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy~     in Kidney Transplant Patients receiving Prograf and Cellcept~   "
222189|NCT00650455|"~     The objectives of the study were to evaluate the efficacy, safety, and tolerability of~     valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to~     assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs~     and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.~   "
222190|NCT00650442|"~     The primary objective of this study was to compare the adhesive quality of the current Mylan~     estradiol placebo transdermal system, with that of an alternate second generation Mylan~     estradiol placebo transdermal system following a single system application. As a secondary~     objective, primary dermal irritation was assessed after removal of each transdermal system.~   "
222191|NCT00650429|"~     This study was conducted to examine the efficacy and tolerability of ziprasidone~     intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the~     treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin~     American population.~   "
222192|NCT00650416|"~     The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5~     mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x 12.5 mg)~     dose administered under fasting conditions.~   "
222193|NCT00650403|"~     The objective of this study is to investigate the bioequivalence of Mylan's paroxetine~     hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x~     40 mg) dose administered under fed conditions to healthy adult volunteers.~   "
222194|NCT00650390|"~     The study was to explore the efficacy of adalimumab in subjects previously treated with~     infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore~     the safety of adalimumab in subjects previously treated with infliximab.~   "
222195|NCT00650377|"~     The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg~     tablets and Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose~     administration under fed conditions.~   "
222196|NCT00650364|"~     The objective of this study was to investigate the bioequivalence of Mylan midodrine HCl 5 mg~     tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose~     administration under fasting conditions.~   "
222197|NCT00650351|"~     The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin~     extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single,~     oral 1000 mg (1 x 1000 mg) dose administered under fed conditions.~   "
222198|NCT00650338|"~     To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering~     intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular~     Hypertension~   "
222199|NCT00650325|"~     The objective of this study was to investigate the bioequivalence of Mylan's sertraline~     hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100~     mg (1 x 100 mg) dose administered under fasting conditions.~   "
222204|NCT00650260|"~     Hypothermia is a common and serious complication during anesthesia and surgery.~     Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and~     exposure to cold operating room environment.~      Various warming methods, such as warm blankets, forced-air warmers and circulating water~     mattresses, are currently used to prevent and treat mild perioperative hypothermia. All are~     cutaneous approaches that rely on heating the peripheral tissues in order to increase the~     thermal core temperature. Application of cutaneous warming system blankets/pads are limited~     by location/extent of operative site; for example, in certain procedures such as~     laparatomies, reconstructive plastic surgery or orthopedic surgery, only a limited amount of~     skin surface is available for warming application. The Dynatherm vitalHEAT technology takes~     advantage of the body's natural thermoregulatory system to channel thermal energy to the~     body's core non-invasively at a rapid rate. The vital heat (vH2) system is designed to treat~     hypothermia during the peri-operative period through a combination of localized heat and~     vacuum application to one hand & forearm; this application 1) opens the arteriovenous~     anastamoses located in the palm of the hand and 2) conductively warms the extremity thus~     effectively warming the blood flow to the body's core. The vital heat vH2 system is a~     portable and compact warming device which provides a non-invasive approach to warming~     patients during surgery.~      The primary objective of this study is to determine if the Dynatherm Medical vitalHEAT (vH2)~     Temperature Management System is as effective as the forced-air warming Bair Hugger™ (Arizant~     Healthcare, Eden Prairie, MN) for maintenance of intraoperative body temperature in patients~     undergoing abdominal surgery under general anesthesia. The critical endpoints to be evaluated~     in making this determination are 1) % of subjects with an average intraoperative esophageal~     temperature of ≥ 36º C and 2) % of subjects with an initial post anesthesia care unit~     sublingual temperature of ≥ 36º C. Secondary objectives include 1) comparison of the core~     body temperatures @ 60 minutes post anesthesia induction, 2) comparison of temperature trends~     during surgery and 3) comparison of the subjects' post anesthesia care unit temperature~     trends and hypothermic symptoms such as shivering.~   "
222205|NCT00650247|"~     The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan~     succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1~     x 100 mg) dose administered under fed conditions.~   "
222206|NCT00650234|"~     The objective of this study was to investigate the bioequivalence of Mylan's metformin~     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,~     oral 500 mg (1 x 500 mg) dose administered under fasting conditions.~   "
222207|NCT00650221|"~     The objective of this study was to compare the rate and extent of absorption of pravastatin~     sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference~     Pravachol® 80 mg Tablets under fasting conditions.~      Based on the results from this study, the two 80 mg pravastatin tablet formulations~     demonstrated bioequivalence under the single-dose fasting conditions.~   "
222208|NCT00650208|"~     The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25~     mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg~     (2 x 25 mg) dose administration under fasting conditions.~   "
222209|NCT00650195|"~     The objective of this study was to investigate the bioequivalence of Mylan metolazone 10 mg~     tablets to Celltech Zaroxolyn® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose~     administration under fasting conditions.~   "
222210|NCT00650182|"~     The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl~     system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.~   "
222211|NCT00650169|"~     The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel~     bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a~     single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.~   "
222212|NCT00650156|"~     Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid~     Arthritis~   "
222213|NCT00650143|"~     Trial design:~      This Phase III, investigator-driven, randomised, placebo-controlled efficacy and safety study~     will compare the effects of Sitagliptin in combination with granulocyte-colony stimulating~     factor (Lenograstim, G-CSF) on the improvement of myocardial function in patients undergoing~     routine percutaneous coronary revascularisation for acute myocardial infarction (time from~     onset of infarction to intervention 2 to 24 hours). The primary objective of this study is to~     compare between a treatment of G-CSF plus Sitagliptin, (G-CSF/Sitagliptin treatment group,~     n=87) versus Placebo (control treatment group, n=87) in change of global myocardial function~     from baseline to 6 months of follow-up.~   "
222214|NCT00650130|"~     The aim of this study is to get new information on the whole blood-plasma-oral fluid ratios~     of psychoactive drugs which are encountered in traffic.~      Samples are taken from drivers suspected of being under the influence of drugs or medicines.~     The samples are analysed with immunological methods and GC-MS.~      Observations from Police and a physician on impairment are combined with the results of the~     different bodily fluids. Observational evaluations and substance concentrations are compared.~   "
222215|NCT00650117|"~     The objective of this study was to investigate the effect of three different types of~     occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h~     manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25~     mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of~     each type of overlay worn with each fentanyl treatment was also assessed after patch removal.~   "
222216|NCT00650104|"~     The purpose of this study is to obtain information on the long-term safety, tolerability, and~     therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for~     patients who participated in either Study 167 or Study 164 to continue receiving ropinirole~     XL if they chose to do so.~   "
222217|NCT00650091|"~     Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's~     ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned~     patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment~     to one of three groups — receiving a combination of prednisone, azathioprine, and NAC~     (combination therapy), NAC alone, or placebo — in a 1:1:1 ratio.~   "
222218|NCT00650078|"~     The purpose of the study is to compare the safety and efficacy, with regards to the signs and~     symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease~     Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.~   "
222219|NCT00650065|"~     The objective of this study was to investigate the bioequivalence of Mylan cetirizine HCl 10~     mg tablets to Pfizer's Zyrtec® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose~     administration under fasting conditions.~   "
222220|NCT00650052|"~     The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100~     mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg)~     dose administered under fasting conditions.~   "
226643|NCT00591149|"~     A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients~     to determine their effect on the control and reduction of tumor size~   "
222221|NCT00650039|"~     The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and~     valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain~     after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary~     objectives were to compare each valdecoxib dose with placebo on additional measures of pain~     intensity, health outcomes, the use of rescue medication, and the occurrence of~     opioid-related symptoms, and to evaluate their safety.~   "
222222|NCT00650026|"~     Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody~     Adalimumab in Subjects with Active Rheumatoid Arthritis~   "
222223|NCT00650013|"~     The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5~     mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose~     administration under fed conditions.~   "
222224|NCT00650000|"~     The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg~     tablets to Cephalon Provigil® 200 mg tablets following a single, oral 200 mg (1 x 200 mg)~     dose administration under fasting conditions.~   "
222225|NCT00649987|"~     The objective of this study was to investigate the bioequivalence of Mylan's albuterol~     sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single,~     oral 8 mg (1 x 8 mg) dose administered under fed conditions.~   "
222226|NCT00649974|"~     The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir~     hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a~     single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.~   "
222227|NCT00649961|"~     Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may~     reduce this risk. The unborn baby receives melatonin from the mother but following premature~     delivery there maybe a period of prolonged melatonin deficiency. This deficiency may be~     harmful because studies suggest that melatonin is important in protecting the brain and~     reducing the risk of brain injury after preterm birth. The purpose of this study is to find~     the ideal dose of melatonin to give to preterm babies. We intend to study a total of 24~     babies less than 31 weeks gestation and who are less than 7 days old.~   "
222228|NCT00649948|"~     The objective of this study was to investigate the bioequivalence of Mylan's metformin~     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,~     oral 500 mg (1 x 500 mg) dose administered under fed conditions.~   "
222229|NCT00649935|"~     The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600~     mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg)~     dose administered under fed conditions.~   "
222230|NCT00649922|"~     To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal~     virus in subject with RA receiving adalimumab or placebo~   "
222231|NCT00649909|"~     The efficacy of low dose aspirin appears to be substantially lower in diabetic patients,~     compared to patients without diabetes.~      We will perform an observational study where we follow up patients with uncontrolled type 2~     Diabetes Mellitus and low response to aspirin (Aspirin Resistance), during a period of 6~     months in the diabetic clinic. Our hypothesis is that glucose control will improve the~     response to aspirin in those patients.~   "
222232|NCT00649896|"~     The primary objective of this study was to compare the adhesive quality of a new formulation~     of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following~     a single system application in 80 healthy postmenopausal female volunteers. As a secondary~     objective, primary dermal irritation was assessed after removal of each transdermal system.~   "
222233|NCT00649883|"~     This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or~     0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in~     healthy children aged 6 to <60 months.~   "
222234|NCT00649870|"~     The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir~     hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a~     single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions.~   "
222235|NCT00649857|"~     The objective of this study was to investigate the bioequivalence of Mylan's cetirizine HCl~     tablets to Pfizer's Zyrtec® tablets following a single, oral 10 mg (1 x 10 mg) dose~     administered under fed conditions.~   "
222236|NCT00649844|"~     The purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine~     in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment~   "
222237|NCT00649831|"~     This study compared the clinical efficacy and safety of azithromycin with that of~     amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with~     an exacerbation of chronic bronchitis.~   "
222238|NCT00649818|"~     The objective of this study was to investigate the bioequivalence of Mylan's lorazepam 2 mg~     tablets to Wyeth's Ativan 2 mg tablets following a single, oral 2 mg (1 x 2 mg) dose~     administered under fasting conditions.~   "
222239|NCT00649805|"~     The objective of this study was to investigate the bioequivalence of Mylan's verapamil HCl~     extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules~     following by a single, oral 300 mg (1 x 300 mg) dose administration sprinkled on one~     tablespoon of applesauce under fasting conditions.~   "
222240|NCT00649792|"~     The purpose of the study is to evaluate the safety, tolerability and activity of~     Fampridine-SR when administered for up to 36 additional months in patients who previously~     participated in the MS-F204 study or until it becomes commercially available, whichever comes~     first.~   "
222241|NCT00649779|"~     The objective of this study was to investigate the bioequivalence of Mylan's albuterol~     sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single,~     oral 8 mg (1 x 8 mg) dose administered under fasting conditions.~   "
222242|NCT00649766|"~     The purpose of this project is to test two different types of health messages, one that is~     developed for a specific group (targeted) and the other that is more personalized to~     individuals (tailored), to see which is better at changing how often people have their eyes~     examined. We hypothesize that people who get the tailored messages will be more likely to get~     a dilated eye exam than people who receive the targeted messages.~   "
226644|NCT00591136|"~     Dose-finding and pharmacokinetic trial of orally administered Indibulin to patients with~     solid tumors.~   "
222243|NCT00649753|"~     The purpose of this study is to evaluate the relationship of pelvic blocking and protocol for~     cranial adjusting with specific pain areas as outlined by Dr. Bertrand DeJarnette in the~     Category II/sacroiliac protocol. An algometer will be used to determine the level of pain at~     specific points before and after each treatment of pelvic blocking with or without cranial~     adjusting.~   "
222244|NCT00649740|"~     The objective of this study was to investigate the bioequivalence of Mylan's topiramate~     sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single,~     oral 25 mg (1 x 25 mg) dose administered under fasting conditions.~   "
222245|NCT00649727|"~     The objective of this study was to investigate the single-dose relative bioavailability of~     Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following~     an oral, single 20 mg (2 x 10 mg) dose under fed conditions.~   "
222246|NCT00649714|"~     The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100~     mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg)~     dose administered under fed conditions.~   "
222247|NCT00649701|"~     The purpose of this study is to develop and test the efficacy of online HIV risk reduction~     interventions among men who have sex with men.~   "
222248|NCT00649688|"~     The objective of this study was to investigate the bioequivalence of Mylan metoprolol~     tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets~     following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fasting~     conditions.~   "
222249|NCT00649675|"~     The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg~     tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x~     15 mg) dose administration under fed conditions.~   "
222250|NCT00649662|"~     The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin~     extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single,~     oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.~   "
222251|NCT00649649|"~     The objective of this study was to investigate the bioequivalence of Mylan quinapril~     hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a~     single, oral 40 mg (1 x 40 mg) dose under fed conditions.~   "
222252|NCT00649636|"~     The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine~     hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg~     (1 x 40 mg) dose administration under fasting conditions.~   "
222253|NCT00649623|"~     The objective of this study was to investigate the bioequivalence of Mylan's olmesartan~     medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1~     x 40 mg) dose administered under fasting conditions.~   "
222254|NCT00649610|"~     The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with~     diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on~     the patient's level of disability and quality of life was also studied.~   "
222255|NCT00649597|"~     The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and~     hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets~     following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting~     conditions.~   "
222256|NCT00649584|"~     This study will examine the safety profile of SGN-35 alone and in combination with~     gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of~     patients.~   "
222257|NCT00649571|"~     The objective of this study was to investigate the bioequivalence of Mylan's doxycycline~     monohydrate 100 mg tablets to Par's Adoxa® 100 mg tablets following a single, oral 100 mg (1~     x 100 mg) dose administered under fasting conditions.~   "
222258|NCT00649558|"~     The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl~     45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose~     administration under fasting conditions.~   "
222259|NCT00649545|"~     The primary objective of this study is to assess the safety (by collecting adverse events and~     serious adverse events) of adalimumab administered every other week to patients with~     moderately to severly active rheumatoid arthritis who have failed prior disease-modifying~     anti-rheumatic drugs (DMARDs).~   "
222260|NCT00649532|"~     The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24~     mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose~     administered under fasting conditions.~   "
222261|NCT00649519|"~     The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and~     benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a~     single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.~   "
222262|NCT00649506|"~     The objective of this study was to evaluate the relative bioavailability of Mylan's~     nitrofurantoin macrocrystals 100 mg capsules to Procter & Gamble's Macrodantin® 100 mg~     capsules following a single, oral 100 mg (1 x 100 mg) dose in 28 healthy, adult, non-tobacco~     using volunteers under fed conditions.~   "
222263|NCT00649493|"~     The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole~     sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20~     mg) dose administration under fed conditions.~   "
222264|NCT00649480|"~     The objective of this study was to investigate the bioequivalence of Mylan balsalazide~     disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg~     (3 x 750 mg) dose administration under fed conditions.~   "
222265|NCT00649467|"~     The objective of this study was to investigate the bioequivalence of Mylan's topiramate~     sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single,~     oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.~   "
222266|NCT00649454|"~     The objective of this study was to investigate the bioequivalence of Mylan's glipizide and~     metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets~     following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fasting~     conditions.~   "
222292|NCT00649116|"~     The objective of this study was to investigate the bioequivalence of Mylan's metoprolol~     tartrate tablets to Novartis's Lopressor® tablets following a single, oral 100 mg (1 x 100~     mg) dose administered under fed conditions.~   "
222267|NCT00649441|"~     The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl~     and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20 mg/25 mg tablets~     following a single, oral 20 mg/25 mg (1 x 20 mg/25 mg) dose administered under fasting~     conditions.~   "
222268|NCT00649428|"~     The purpose of this study is to evaluate the safety profile and the treatment effect of~     Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold~     wrinkles.~   "
222269|NCT00649415|"~     To compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in~     subjects with moderate to severe menstrual cramping pain associated with primary~     dysmenorrhea.~   "
222270|NCT00649402|"~     The objective of this study was to investigate the bioequivalence of Mylan amlodipine and~     benazepril HCl 10 mg/20 mg to Novartis Lotrel® 10 mg/20 mg combination capsules following a~     single, oral 10 mg/20 mg (1 x 10 mg/20 mg) dose administered under fed conditions.~   "
222271|NCT00649389|"~     To determine the effectiveness of four different strength combinations of three approved~     anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for~     lowering blood pressure.~   "
222272|NCT00649376|"~     The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180~     mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg)~     dose administered under fasting conditions.~   "
222273|NCT00649363|"~     The objective of this study was to investigate the bioequivalence of Mylan's ondansetron~     orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a~     single, oral 8 mg (1 x 8 mg) dose administered under fasting conditions.~   "
222274|NCT00649350|"~     The objective of this study was to investigate the bioequivalence of Mylan's metformin~     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,~     oral 750 mg (1 x 750 mg) dose administered under fed conditions.~   "
222275|NCT00649337|"~     The purpose of this study is to determine whether addition of automated whole breast~     ultrasound to the usual screening mammography in a population of asymptomatic women with~     mammographically dense breasts will result in a significantly greater number of breast~     cancers discovered than would be found by mammography alone.~   "
222276|NCT00649324|"~     The objective of this study was to investigate the bioequivalence of Mylan's~     hydrochlorothiazide 50 mg tablets to Ivax's Hydrochlorothiazide 50 mg tablets following a~     single, oral 50 mg (1 x 50 mg) dose administered under fasting conditions.~   "
222277|NCT00649311|"~     The purpose this study is to compare the efficacy of eplereonone and losartan in patients~     with mild to moderate hypertension.~   "
222278|NCT00649298|"~     This study will assess clinical outcomes of extended weekly hours of haemodialysis (>= 24~     hours per week) compared with standard hours of haemodialysis (<=18 hours/week) in people~     with ESKD.~   "
222279|NCT00649285|"~     The objective of this study was to investigate the bioequivalence of Mylan's nitrofurantoin~     monohydrate/macrocrystals capsules to Procter & Gamble's Macrobid® capsules following a~     single, oral 100 mg (1 x 100 mg) dose under fed conditions.~   "
222280|NCT00649272|"~     The objective of this study was to investigate the bioequivalence of Oxybutynin Chloride~     Extended-Release Tablets, 15 mg (Mylan Pharmaceuticals Inc.) to Ditropan XL® Extended-~     Release Tablets, 15 mg (ALZA Corporation; Distributed and marketed by: Ortho-McNeil~     Pharmaceuticals Inc.) following a single, oral 15 mg dose (1 x 15 mg tablet) under fasting~     conditions.~   "
222281|NCT00649259|"~     The objective of this study was to investigate the single-dose relative bioavailability of~     Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following~     an oral, single 20 mg (2 x 10 mg) dose under fed conditions.~   "
222282|NCT00649246|"~     This is an observational study designed to help researchers understand the genetics and~     pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease~     complication prediction.~   "
222283|NCT00649233|"~     The objective of this study was to investigate the bioequivalence of Mylan metoprolol~     tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets~     following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fed conditions.~   "
222284|NCT00649220|"~     To investigate the potential to reduce concomitant antipsychotic medication use in subjects~     with moderate dementia of Alzheimer's type, treated with memantine.~   "
222285|NCT00649207|"~     This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given~     together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain~     metastases.~   "
222286|NCT00649194|"~     The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole~     sodium delayed-release 20 mg tablets relative to Eisai's Aciphex® delayed-release 20 mg~     tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.~   "
222287|NCT00649181|"~     The objective of this study was to investigate the bioequivalence of Mylan metolazone 5 mg~     tablets to Celltech Zaroxolyn® 5 mg tablets following a single, oral 10 mg (2 x 5 mg) dose~     administration under fasting conditions.~   "
222288|NCT00649168|"~     The objective of this study was to assess the single-dose relative bioavailability of Mylan~     Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine~     mesylate capsules, following the administration of a 10 mg dose, under fed conditions.~   "
222289|NCT00649155|"~     The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin~     extended-release 500 mg tablets to Bayer's Cipro® XR 500 mg tablets following a single, oral~     500 mg (1 x 500 mg) dose administered under fasting conditions.~   "
222290|NCT00649142|"~     Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair.~     However no prospective study has investigated potential predisposing factors for development~     of pain, including genetic, psychosocial and detailed neurophysiological assessment of~     surgical method.~      The current study will assess the above factors in a prospective study.~   "
222291|NCT00649129|"~     The objective of this study was to investigate the single-dose relative bioavailability of~     Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following~     an oral, single 20 mg (2 x 10 mg) dose under fasting conditions.~   "
226669|NCT00590811|"~     The aim of this study is to determine the prevalence of menstrual cycle related pain~     complains in adolescents and young adults.~   "
222293|NCT00649103|"~     The objective of this study was to investigate the bioequivalence of Mylan quinapril~     hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a~     single, oral 40 mg (1 x 40 mg) dose under fasting conditions.~   "
222294|NCT00649090|"~     The purpose of this study was to give access to postmenopausal women with estrogen sensitive~     primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use~     of tamoxifen and to collect all serious adverse events.~   "
222295|NCT00649077|"~     The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg~     tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x~     15 mg) dose administration under fasting conditions.~   "
222296|NCT00649064|"~     The purpose of this study is to see if differences exist in outcome in patients with~     schizophrenia or schizoaffective disorder who were switched from other antipsychotics to~     ziprasidone.~   "
222297|NCT00649051|"~     The objective of this study was to investigate the bioequivalence of Mylan metolazone 2.5 mg~     tablets to Celltech Zaroxolyn® 2.5 mg tablets following a single, oral 10 mg (4 x 2.5 mg)~     dose administration under fasting conditions.~   "
222298|NCT00649038|"~     The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and~     hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets~     following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fed~     conditions.~   "
222299|NCT00649025|"~     The medications being used in this study are individually approved by the Food and Drug~     Administration (FDA). The medication under investigation is a combination of two medications~     in one inhaler. The purpose of this study is to determine how well your asthma is controlled~     when taking one of the three treatment.~   "
222300|NCT00649012|"~     The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl~     45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose~     administration under fed conditions.~   "
222301|NCT00648999|"~     To demonstrate that patients treated with Kaletra have an improvement in their quality of~     life compared to the quality of life they had with their previous NRTI therapy.~   "
222302|NCT00648986|"~     The purpose of this study is to determine whether topical tazarotene (Tazorac), a~     receptor-selective synthetic retinoid that normalizes epidermal differentiation, ameliorates~     signs and symptoms of brittle nails.~   "
222303|NCT00648973|"~     The study was to determine if the drug worked to relieve nasal congestion experienced by~     people with seasonal allergies.~   "
222304|NCT00648960|"~     The objective of this study was to investigate the bioequivalence of Genpharm's~     clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the~     Biaxin® filmtab® (Abbott Laboratories USA) administered under fasting conditions. Sixty-four~     (64) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were~     randomized, in this two-period, two-treatment crossover bioequivalence study conducted by~     Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.~      Statistical analysis of the data reveals that 90% confidence intervals are within the~     acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters~     AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets~     are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered~     under fasting conditions.~   "
222305|NCT00648947|"~     The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel~     bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a~     single, oral 75 mg (1 x 75 mg) dose administered under fasting conditions.~   "
222306|NCT00648934|"~     The objective of this study was to investigate the bioequivalence of Mylan's topiramate~     sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a~     single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.~   "
222307|NCT00648921|"~     The objective of this study was to investigate the bioequivalence of Mylan's olanzapine 5 mg~     tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose~     administered under fasting conditions.~   "
222308|NCT00648908|"~     The purpose of this study is to evaluate the safety, tolerability and activity of~     Fampridine-SR when administered for up to 36 additional months, or until it becomes~     commercially available whichever comes first, in subjects who previously participated in~     Acorda Therapeutics Protocol MS-F203.~   "
222309|NCT00648895|"~     The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another~     beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the~     mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other~     biomarkers.~   "
222310|NCT00648882|"~     The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine~     sodium 300 mcg tablets to Abbott's Synthroid® 300 mcg tablets following a single, oral 600~     mcg dose (2 × 300 mcg) administered under fasting conditions.~   "
222311|NCT00648869|"~     Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3~     period, 3 treatments, and randomized design.~      Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg & Metformin tablet~     500mg~   "
222312|NCT00648856|"~     The objective of this study was to investigate the bioequivalence of Mylan's sertraline~     hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100~     mg (1 x 100 mg) dose administration under fed conditions.~   "
222313|NCT00648843|"~     The objective of this study was to investigate the single-dose relative bioavailability of~     Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following~     an oral, single 20 mg (4 x 5 mg) dose under fed conditions.~   "
222331|NCT00648596|"~     To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall~     Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the~     Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]).~     Furthermore, to determine if the improvement obtained in self-esteem was related to the main~     erectile dysfunction (ED) co-morbidities type and/or number.~   "
222332|NCT00648583|"~     The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24~     mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose~     administered under fed conditions.~   "
222314|NCT00648830|"~     The objective of this study was to investigate the bioequivalence of Genpharm's~     clarithromycin tablets following a single, oral 250 mg (1 x 250 mg) dose compared to the~     Biaxin® filmtab® (Abbott Laboratories USA) administered under fasted conditions. Thirty-four~     (34) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were~     randomized, in this four-period, two-treatment crossover bioequivalence study conducted by~     Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.~      Statistical analysis of the data reveals that 90% confidence intervals are within the~     acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters~     AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 250 mg tablets~     are bioequivalent to Biaxin® filmtab® 250 mg tablets (Abbott Laboratories USA) administered~     under fasted conditions.~   "
222315|NCT00648817|"~     Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the~     impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg~     compared with placebo in non-HIV-1 infected healthy adult males. Additionally, endothelial~     function, adipocytokines and lipids will be monitored.~   "
222316|NCT00648804|"~     The objective of this study was to investigate the bioequivalence of Mylan's ondansetron~     orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a~     single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.~   "
222317|NCT00648791|"~     The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg~     tablets to Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose~     administration under fasting conditions.~   "
222318|NCT00648778|"~     The objective of this study was to investigate the bioequivalence of Mylan loxapine succinate~     25 mg capsules to Watson Loxitane 25 mg capsules following a single, oral 25 mg (1 x 25 mg)~     dose administration under fasting conditions.~   "
222319|NCT00648765|"~     The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1~     mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg)~     dose administration under fed conditions.~   "
222320|NCT00648739|"~     The purpose of this study is to determine the safety and best dose of ALXN6000 in treating~     relapsing or refractory B-CLL or MM and to study how ALXN6000 may help the immune system~     fight cancer.~   "
222321|NCT00648726|"~     To validate the efficacy and safety of azithromycin for the treatment of Chinese patients~     hospitalized with community-acquired pneumonia (CAP), compared with cefuroxime or the~     combination of cefuroxime plus oral erythromycin.~   "
222322|NCT00648713|"~     The objective of this study was to investigate the bioequivalence of Mylan's terbinafine~     hydrochloride tablets to Novartis' Lamisil® tablets following a single, oral 250 mg (1 x 250~     mg) dose administered under fed conditions.~   "
222323|NCT00648700|"~     The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine~     sodium 300 μg tablets to Lloyd's Levothroid® 300 μg tablets following a single 600 μg (2 x~     300 μg) dose administered in healthy adult volunteers under fasting conditions. Statistical~     analysis of the data revealed that 90% confidence intervals were within the acceptable~     bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr~     and LNCPEAK for baseline corrected total levothyroxine.~   "
222324|NCT00648687|"~     Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have~     ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive~     2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention~     group) or nothing (control). NIPS scale will be applied two minutes before examination and~     two minutes after examination.~   "
222325|NCT00648674|"~     Single site clinical study utilizing the novel technology of microarrays to identify and~     characterize the molecular mechanisms through which Apligraf promotes healing of venous leg~     ulcers.~   "
222326|NCT00648661|"~     The objective of this study was to investigate the bioequivalence of Mylan's escitalopram~     oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x~     20 mg) dose administered under fed conditions.~   "
222327|NCT00648648|"~     This study will investigate MK1775 alone and in combination with one of the following three~     drugs: gemcitabine, cisplatin, and carboplatin in patients with advanced solid tumors. The~     purpose of the study is to test safety and tolerability of MK1775 alone and in combination,~     and to find the maximum tolerated dose (MTD) of MK1775 as monotherapy and in combination~     therapy.~   "
222328|NCT00648635|"~     The goal of this study is to learn how the treatment given to patients with recurrent rectal~     cancer affects their well being and quality of life.~   "
222329|NCT00648622|"~     The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5~     mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x 12.5 mg)~     dose administered under fed conditions.~   "
222330|NCT00648609|"~     The purpose of this study is to compare in home support services for patients with COPD with~     usual care. The study is designed to evaluate the impact of an interdisciplinary palliative~     care team on community based self management of advanced COPD.~      A total of thirty patients will be enrolled into this study. Twenty patients will be randomly~     assigned to receive usual care, and ten patients will be randomly assigned to usual care plus~     in home support services. This study will use objective criteria to identify patients with~     COPD likely to benefit from home based palliative care services. The patients will undergo~     initial assessment by medical, social work, and spiritual care personnel followed by a family~     meeting to establish a care plan. Periodic scheduled visits, and as needed unscheduled visits~     to address urgent needs will occur over one year's time in an attempt to return patients with~     COPD to the center of decision making regarding their care, avoid acute exacerbations and~     thereby avoid unscheduled clinic and ER visits. Patients will complete the QOL survey and~     symptom assessment scale upon initial intervention. After obtaining information from all~     patients who qualify for the study, participants will be randomized into cohorts. Those who~     are randomized to serve as cases will be provided with community based self management~     services by an interdisciplinary palliative care team. The control group will receive~     standard care. At the conclusion of 12 months both cases and controls will again complete the~     QOL survey,medical utilization, and symptom assessment.~   "
226670|NCT00590798|"~     To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely~     ambulate within 30 minutes of catheterization.~   "
222333|NCT00648570|"~     The objective of this study was to investigate the bioequivalence of Mylan's escitalopram~     oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x~     20 mg) dose administered under fasting conditions.~   "
222334|NCT00648557|"~     The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine~     sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x~     200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine~     healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label,~     randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D.~     Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that~     90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for~     the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total~     L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are~     bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200~     μg) dose under fasting conditions~   "
222335|NCT00648544|"~     This study was designed to compare the rate and extent of absorption of pravastatin sodium~     from the following formulations under fed conditions:~        1. Pravastatin Sodium 80 mg Tablets (Genpharm Inc. Canada)~        2. Pravachol® 80 mg Tablets (Bristol-Myers Squibb Co., U.S.A.) Bioequivalence of these~          formulations was assessed for pravastatin.~      Based on the results from this study, these two 80 mg pravastatin tablet formulations~     demonstrated bioequivalence under the single-dose fed conditions.~   "
222336|NCT00648531|"~     The objective of this study was to investigate the bioequivalence of Mylan balsalazide~     disodium 750 mg capsules and Salix Colazal® 750 mg capsules following a single, oral 2250 mg~     (3 x 750 mg) dose administration under fasting conditions.~   "
222337|NCT00648518|"~     The objective of this study was to investigate the bioequivalence of Mylan's metformin~     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,~     oral 750 mg (1 x 750 mg) dose administered under fasting conditions.~   "
222338|NCT00648505|"~     The objective of this study was to investigate the bioequivalence of Mylan's glipizide and~     metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets~     following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fed~     conditions.~   "
222339|NCT00648492|"~     The objective of this study is to investigate the bioequivalence of Mylan's metformin~     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,~     oral 500 mg (1 x 500 mg) dose administered under fed conditions.~   "
222340|NCT00648479|"~     We intend to include10 patients in this study and trial. Prior to treatment they will sign an~     informed consent form, stating that they are acquainted with the surgical procedure and~     study, and that they consent to participate in the study.~      Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes)~     using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the~     same operation using the new navigation system:The Guiding star method.~      The allocation will be random.~   "
222341|NCT00648466|"~     The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan~     succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1~     x 100 mg) dose administration under fasting conditions.~   "
222342|NCT00648453|"~     To determine whether in the laser Doppler flowmetric parameters characteristic of endothelial~     dysfunction at patients with clinically manifest atherosclerosis any change can be detected~     at plavix (clopidogrel) treatment. Laser Doppler /LD/ measurement combined with iontophoresis~     evaluates the effect of acetylcholine /ACh/ /endothelium dependent/ and sodium nitroprusside~     /NSP/ /endothelium independent/ on the microcirculation of the skin~   "
222343|NCT00648440|"~     The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5~     mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose~     administration under fed conditions.~   "
222344|NCT00648427|"~     The objective of this study was to investigate the bioequivalence of Mylan's paroxetine~     hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a~     single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.~   "
222345|NCT00648414|"~     The objective of this study was to investigate the effect of clinical procedures on the drug~     delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals~     Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen~     Pharmaceutica by ALZA Corporation.~   "
222346|NCT00648401|"~     The objective for this study was to investigate the bioequivalence of Mylan's verapamil HCl~     extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules~     following a single, oral 300 mg (1 x 300 mg) dose administration under fed conditions.~   "
222347|NCT00648388|"~     The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100~     mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg)~     dose administered under fasting conditions.~   "
222348|NCT00648375|"~     This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in~     people with post-traumatic stress disorder.~   "
222349|NCT00648362|"~     The objective of this study was to investigate the bioequivalence of Mylan's glimepiride 1 mg~     tablets to Aventis Amaryl® 1 mg tablets following a single, oral 1 mg (1 x 1 mg) dose~     administered under fasting conditions.~   "
222350|NCT00648349|"~     The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole~     sodium delayed-release 20 mg tablets to Eisai's Aciphex® delayed-release 20 mg tablets~     following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.~   "
222351|NCT00648336|"~     The objective of this study was to investigate the bioequivalence of Mylan's mercaptopurine~     50 mg tablets to Gate's Purinethol® 50 mg tablets following a single, oral 50 mg (1 x 50 mg)~     dose administered under fasting conditions.~   "
222352|NCT00648323|"~     The primary objectives were to determine the efficacy and safety of the GITS formulation of~     Doxazosin in Taiwanese patients with prostate enlargement.~   "
222423|NCT00647387|"~     The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA)~     in September, 2007. This study is designed to further evaluate the safety and effectiveness~     in subjects implanted with the AMPLATZER Muscular VSD Occluder.~   "
222353|NCT00648310|"~     Despite the great number of reports about the efficacy of oestrogens or antimuscarinics on~     OAB symptoms, so far no author has tried to investigate whether the concomitant~     administration of these two drugs, acting on two different pathophysiological mechanisms,~     could have a synergic effect reducing the rate of non-responders to treatment.~   "
222354|NCT00648297|"~     The objective of this study was to investigate the bioequivalence of Mylan's~     nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets~     following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fed conditions.~   "
222355|NCT00648284|"~     The primary objective of this study is to assess the total CV risk in patients with type 2~     diabetes and also to assess the impact of rosiglitazone in the total CV risk and the~     parameters of metabolic syndrome.~   "
222356|NCT00648271|"~     The objective of this study was to investigate the bioequivalence of Mylan's metoprolol~     tartrate tablets to Novartis' Lopressor® tablets following a single, oral 50 mg (2 x 25 mg~     tablets for Mylan's formulation and 1 x 50 mg for Lopressor®) dose administered under fed~     conditions.~   "
222357|NCT00648258|"~     To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10~     mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of~     osteoarthritis (OA) of the knee or hip. The study was designed to collect comparative~     information for the local population (Taiwan).~   "
222358|NCT00648245|"~     The symptoms associated with COPD include overproduction of mucus and inflammation in the~     lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial~     growth and associated COPD exacerbations. Therefore, a treatment that inhibits mucus~     overproduction or blocks inflammation could benefit COPD patients. The drug under evaluation~     in this study, BIO-11006 Inhalation Solution, is a new drug that may inhibit overproduction~     of mucus and may have important anti-inflammatory properties.~   "
222359|NCT00648232|"~     This study will compare the effectiveness of brief versus detailed HIV counseling sessions,~     paired with referrals to either HIV-specific medical care or usual care, in reducing HIV risk~     behavior and in increasing treatment adherence in Uganda.~   "
222360|NCT00648219|"~     The objective of this study was to investigate the bioequivalence of Mylan's olmesartan~     medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1~     x 40 mg) dose administered under fed conditions.~   "
222361|NCT00648206|"~     This study intends to supply information about the prevalence of psychoactive drugs and~     alcohol in suspected DUI samples which are suspected of only one of these rather than both~     drugs and alcohol.~      Police samples for suspected DUI samples that have been sent for alcohol analysis or drug~     analysis only will be screened for drugs and alcohol respectively.~   "
222362|NCT00648193|"~     The objective of this study is to investigate the bioequivalence of Mylan's paroxetine~     hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x~     40 mg) dose administered under fasting conditions to healthy adult volunteers.~   "
222363|NCT00648180|"~     The objective of this study was to investigate the bioequivalence of Mylan's doxycycline~     monohydrate 100 mg tablets to Par's Adoxa® 100 mg tablets following a single, oral 100 mg (1~     x 100 mg) dose administered under fed conditions.~   "
222364|NCT00648167|"~     This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a~     treatment for hyperphosphatemia in patients with End-Stage Renal Disease.~   "
222365|NCT00648154|"~     The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg~     tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose~     administered under fed conditions.~   "
222366|NCT00648141|"~     To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac~     for the treatment of ankylosing spondylitis~   "
222367|NCT00648128|"~     The objective of this study was to investigate the bioequivalence of Genpharm's~     clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the~     Biaxin® filmtab® (Abbott Laboratories USA) administered under fed conditions. Forty-four (44)~     healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized,~     in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard,~     M.D. at Algorithme Pharma Inc. Montreal, Canada.~      Statistical analysis of the data reveals that 90% confidence intervals are within the~     acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters~     AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets~     are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered~     under fed conditions.~   "
222368|NCT00648115|"~     The purpose of this research is to test the usefulness of a vocational rehabilitation program~     for veterans with a history of felonies who also have a mental illness or have substance~     dependency.~   "
222369|NCT00648102|"~     This research study is for individuals who have advanced breast, colon, pancreatic, ovarian~     or bladder cancer. Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine)~     to see if it can be used to make the immune system attack the cancer. The study includes~     administration of additional treatments, in combination, thought to enhance the immune~     response effect. This study specifically administers the vaccine systemically to explore~     whether dendritic cell targeted vaccines can generate more robust effects via intravenous~     injection. (CDX 1307-02)~   "
222370|NCT00648089|"~     EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the~     effects of a single erythropoietin administration on infarct size and cardiac remodeling in~     patients with acute myocardial infarction. Eligible patients will be randomly assigned to~     receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional~     therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac~     magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months~     later.~   "
222371|NCT00648076|"~     The objective of this study was to investigate the bioequivalence of Mylan's divalproex~     sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a~     single, oral 500 mg (1 x 500 mg) dose administered under fed conditions.~   "
222372|NCT00648063|"~     The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg~     tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose~     administered under fasting conditions.~   "
222373|NCT00648050|"~     The objective for this study was to investigate the bioequivalence of Mylan's verapamil HCl~     extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules~     following evening administration of a single, oral 300 mg (1 x 300 mg) dose administration~     under fasting conditions.~   "
222374|NCT00648037|"~     The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by~     the monthly administration of an (antibody) protein against B lymphocytes called Rituximab.~     Although this medicine has been approved by the Food and Drug Administration to treat~     patients with other types of lymphomas, and has been used to treat a small number of patients~     with EBV lymphomas and other types of B-cell leukemias, it has not been approved to try and~     prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore~     experimental.~   "
222375|NCT00648024|"~     The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1~     mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg)~     dose administration under fasting conditions.~   "
222376|NCT00648011|"~     The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl~     and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20mg/ 25 mg tablets~     following a single, oral 20/25 mg (1 x 20/25 mg) dose administration under fed conditions.~   "
222377|NCT00647998|"~     Numerous neuroprotectants have been effective when given prior to ischemic stroke in animals,~     yet they have all have failed when given after ischemic stroke in humans. A novel approach to~     ischemic neuroprotection is needed. Many patients who undergo cardiac, vascular, and~     neurosurgical procedures develop ischemic central nervous system (CNS) complications. These~     high risk surgeries present a unique opportunity to administer neuroprotectant medication~     prior to the injury, greatly increasing the likelihood that it will have a positive impact on~     outcomes. Patients undergoing descending thoracic aortic (DTA) and thoracoabdominal aortic~     (TAA) surgery have a particularly high rate of both brain and spine ischemia. In addition,~     these surgeries require placement of a lumbar cerebrospinal fluid (CSF) drain, allowing~     access to CSF in order to monitor markers of injury and penetration of medication into the~     CNS. We are performing a pilot dose finding trial of prophylactic darbepoetin alfa, a~     long-acting erythropoiesis medication with putative neuroprotectant properties, in patients~     undergoing DTA and TAA surgery.~   "
222378|NCT00647985|"~     The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180~     mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg)~     dose administered under fed conditions.~   "
222379|NCT00647972|"~     The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg~     tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose~     administration under fasting conditions.~   "
222380|NCT00647959|"~     The objective of this study was to investigate the bioequivalence of Mylan's doxycycline~     monohydrate 150 mg tablets to Par's Adoxa® 150 mg tablets following a single, oral 150 mg (1~     x 150 mg) dose administered under fasting conditions.~   "
222381|NCT00647946|"~     A previous study substituting zidovudine or stavudine to abacavir in patients with severe or~     moderate lipoatrophy has shown an increase in limb fat by DEXA. This study was conducted over~     a 24-week period and although improved outcomes were documented by objective measures, DEXA~     scans, subjective observation did not correspond. Longer-term follow up of these patients is~     required.~      This 48 week study is designed to compare the substitution of the thymidine analogues~     zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated~     with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb~     fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed~     tomography (CT) scans and improved cholesterol and triglycerides.~   "
222382|NCT00647933|"~     The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety~     of Org 36286 after a single subcutaneous administration in healthy females.~   "
222383|NCT00647920|"~     A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as~     Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with~     Methotrexate~   "
222384|NCT00647907|"~     The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment~     of fungal infections~   "
222385|NCT00647894|"~     The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 1 mg~     Extended-release tablets to Pharmacia & Upjohn's Xanax XR 1 mg tablets following a single,~     oral 3 mg (3 x 1 mg) dose administered under fasting conditions.~   "
222386|NCT00647881|"~     The objective of this study was to investigate the bioequivalence of Mylan's paroxetine~     hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a~     single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.~   "
222387|NCT00647868|"~     In this study the serum concentration of testosterone and its main metabolite DHT will be~     measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment~     regimens (once and twice daily) and administration times will be tested. The serum levels~     obtained will be compared with those of healthy men.~      It is expected that intranasal administration of Nasobol will restore testosterone and DHT~     levels to nearly normal.~   "
222388|NCT00647855|"~     The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine~     sodium 300 μg tablets to Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x~     300 μg) dose administered in healthy volunteers under fasting conditions. Single-dose~     pharmacokinetic parameters for baseline corrected total L-thyroxine and non-baseline~     corrected total L-triiodothyronine were calculated using noncompartmental techniques.~   "
222389|NCT00647842|"~     The objective of this study was primarily to investigate the bioequivalence and secondly to~     assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system~     with and without an overlay system following a single 25 µg/hr application worn for 72 hours.~   "
222409|NCT00647569|"~     The aim of the present project is to investigate whether use of biological mesh at the donor~     site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional~     hernia formation compared to the usual abdominal wall closure after abdominal rotation flap~     operation in surgery for advanced pelvic cancer.~   "
222424|NCT00647374|"~     The proposed project will study the consequence of short term limb immobility on the patterns~     of brain activity using functional imaging (fMRI)~   "
222390|NCT00647829|"~     The study was performed to evaluate the analgesic efficacy, safety, and tolerability of~     valdecoxib 20 mg twice daily (BID), valdecoxib 40 mg once daily (QD), and placebo in patients~     with moderately to severely painful symptomatic sore throat over a 24-hour period. In~     addition, the study was to validate a new scale and criteria for measuring pain in sore~     throat and evaluate the effects of selective serotonin reuptake inhibitors and past sore~     throat pain on pain score and efficacy of analgesics. The study also examined what type of~     medications are commonly used for sore throat and whether this information has relevance to~     analgesic efficacy.~   "
222391|NCT00647816|"~     The objective of this study was to investigate the bioequivalence of Mylan's propranolol~     hydrochloride extended-release 160 mg capsules to Wyeth's Inderal LA® 160 mg capsules~     following a single, oral 160 mg (1 x 160 mg) dose administration under fasting conditions.~   "
222392|NCT00647790|"~     The purpose of this study is to find a way to learn the hormone receptor status of a tumor~     before surgery is done. By testing for the hormone receptor proteins, doctors can find out if~     the breast cancer uses hormones to grow. This is important since the hormone receptor status~     of a tumor helps doctors decide if extra treatment like chemotherapy or pills are needed.~   "
222393|NCT00647777|"~     The objective of this study was to investigate the bioequivalence of Mylan olanzapine 5 mg~     tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose~     administered under fed conditions.~   "
222394|NCT00647764|"~     Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an~     experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in~     patients with cancer.~   "
222395|NCT00647751|"~     The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25~     mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg~     (2 x 25 mg) dose administration under fed conditions.~   "
222396|NCT00647738|"~     The objective of this study was to investigate the bioequivalence of Genpharm's baclofen~     tablets following a single, oral 20 mg (1 x 20 mg) dose compared to the Baclofen USP (Watson~     Laboratories Inc., USA) administered under fasting conditions. Twenty-seven (27) healthy,~     light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this~     two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at~     Algorithme Pharma Inc. Montreal, Canada.~      Statistical analysis of the data reveals that 90% confidence intervals are within the~     acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters~     AUCT, AUCI and Cmax. This study demonstrates that Genpharm's baclofen 20 mg tablets are~     bioequivalent to Baclofen USP 20 mg tablets (Watson Laboratories Inc., USA) administered~     under fasting conditions.~   "
222397|NCT00647725|"~     Painless labor is an essential part in woman's health care. Labor analgesia in the active~     phrase is in popular use currently. However, parturients are still haunted by the labor~     delivery pain in the latent phrase up to 7-8 hours, especially for the nulliparas. Therefore,~     we hypothesized that labor analgesia in the latent phrase of the first delivery stage would~     provide superior health care for laboring women. In addition, such analgesia technique would~     not prolong the time of uterine dilation and labor delivering.~   "
222398|NCT00647712|"~     The objective of this study was to investigate the bioequivalence of Mylan's divalproex~     sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a~     single, oral 500 mg (1 x 500 mg) dose administered under fasting conditions.~   "
222399|NCT00647699|"~     Prospective, randomized multicenter study to determine the safety and effectiveness of~     performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with~     progressive keratoconus.~   "
222400|NCT00647686|"~     The objective of this study was primarily to investigate the bioequivalence and secondly to~     assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system~     with and without an overlay system following a single 25 µg/hr application worn for 72 hours.~   "
222401|NCT00647673|"~     The objective of this study was to investigate the bioequivalence of Mylan's verapamil HCl~     extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules~     following evening administration of a single, oral 300 mg (1 x 300 mg) dose under fasting~     conditions.~   "
222402|NCT00647660|"~     The objective of this study was to investigate the bioequivalence of Mylan's~     nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets~     following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fasting~     conditions.~   "
222403|NCT00647647|"~     The objective of this study was to investigate the bioequivalence of Mylan's terbinafine~     hydrochloride 250 mg tablets to Novartis' Lamisil® 250 mg tablets following a single, oral~     250 mg (1 x 250 mg) dose administered under fasting conditions.~   "
222404|NCT00647634|"~     The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 3 mg~     Extended-release tablets to Pharmacia & Upjohn's Xanax XR® 3 mg tablets following a single,~     oral 3 mg (1 x 3 mg) dose administered under fasting conditions.~   "
222405|NCT00647621|"~     The objective of this study was to investigate the steady-state bioequivalence of Mylan's~     extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg~     (3x100mg), under both fasting and fed conditions.~   "
222406|NCT00647608|"~     The objective of this study was to investigate the bioequivalence of Mylan's propranolol~     hydrochloride extended-release 160 mg capsules to Wyeth's Inderal® LA 160 mg capsules~     following a single, oral 160 mg (1 x 160 mg) dose administered under fed conditions.~   "
222407|NCT00647595|"~     The purpose of this study is to examine the effect of exercise during pregnancy upon maternal~     metabolism, including weight gain, fat distribution, and levels of glucose and cholesterol.~     We will also conduct a pilot study to examine the feasibility of studying the health of~     infants born to women in this study.~   "
222408|NCT00647582|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy during and after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects of giving radiation therapy during~     and after lumpectomy and to see how well it works in treating women with stage I or stage II~     breast cancer.~   "
222410|NCT00647556|"~     The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel~     0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with~     tolerability assessment as a secondary objective.~   "
222412|NCT00647530|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after~     surgery. It is not yet known whether chemotherapy is more effective with or without~     panitumumab in treating patients with colon cancer.~      PURPOSE: This randomized phase III trial assessing whether preoperative chemotherapy and/or~     an anti-EGFR monoclonal antibody improve outcome in high risk operable colon cancer.~   "
222413|NCT00647517|"~     Tramadol 37.5 mg/APAP 325 mg combination tablets (ULTRACET®) were effective and safe as addon~     therapy with COX-2 NSAID for treatment of osteoarthritis (5) and chronic low back pain~     (6).There is no clinical trial regarding tramadol usage in chronic inflammatory arthritis~     such as rheumatoid arthritis (RA) or ankylosing spondylitis. It would be important to do a~     pilot clinical trial on add-on effect of tramadol to NSAID in patients with AS or RA.~   "
222414|NCT00647504|"~     Prospective clinical observational registry study including consecutive patients with~     clinical signs or symptoms due to in-stent restenosis (ISR) or definite (ARC criteria) stent~     thrombosis (ST).~      Study hypothesis:~      Initial Stent implantation quality (due to technique/problems) are possible major~     determinants of ST and ISR in real life practice.~      Both early, late, and very late ST, and ISR are important factors for long term outcome after~     initial stent implantation.~      Primary objective:~        -  To elucidate the possible cause(s) of thrombosis or restenosis after stent implantation~          in real life practice by clinical, angiographic and IVUS evaluation.~      Secondary objective:~        -  To describe the clinical manifestation [stable angina pectoris (AP), unstable AP,~          non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation MI] of the index event~          (inclusion).~        -  To describe the characteristics of patient, lesion and procedure of the initial~          percutaneous coronary intervention (PCI).~        -  To describe the antithrombotic pharmacological therapy preceding the index event.~        -  To describe clinical outcome (death, MI, revascularization, CCS angina class) following~          treatment of the index event during 12 month follow-up.~        -  To describe safety of the IVUS procedure (product or procedural related complications/~          malfunctions).~   "
222415|NCT00647491|"~     The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics~     of three doses of adalimumab in adult Japanese subjects with RA~   "
222416|NCT00647478|"~     The aim is to assess the relationship between levels of IGF-I system components and cognitive~     status in patients with Alzheimer's disease (AD), in elderly subjects with normal cognitive~     function, and in patients with mild cognitive impairment (MCI).~   "
222417|NCT00647465|"~     Influenza vaccination reduces the morbidity and mortality associated with influenza infection~     in at risk groups including the elderly and individuals with an impaired immune response, but~     is not totally protective in all recipient. Cytokines including type I interferons are known~     to play a key role in the innate immune response to virus infection and in the induction of~     the primary adaptive-immune response. Thus, we evaluated the safety of sublingual~     administration of IFNa and its effect on immune response to influenza vaccination in a~     randomized double-blind placebo controlled study in elderly institutionalized individuals.~   "
222418|NCT00647452|"~     Purpose:~      To investigate VLDL-TG metabolism in exercise in healthy volunteers to determine the~     contribution of VLDL-TG in exercise and eventual gender differences~   "
222419|NCT00647439|"~     This study will identify genes that are associated with inflammation or degeneration of the~     retina (membrane lining the back of the eye that relays vision signals to the brain). It is~     thought that many retinal conditions are due to an altered immune system and are based on how~     the person s genes function and communicate.~      People 4 years of age or older who have a retinal condition such as uveitis, age-related~     macular degeneration or diabetic retinopathy may be eligible for this study. Healthy~     volunteers and healthy people who have a family member with one of these conditions are also~     eligible. Patients with inherited retinal degeneration are excluded.~      Participants undergo the following tests and procedures:~        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to~          examine the pupils, lenses, retina and eye movements. Photographs of the inside of the~          eye may also be taken. The pupils are dilated with drops for this examination.~        -  Blood draw for genetic testing.~      Participants may also undergo one or more of the following tests:~        -  Optical coherence tomography. This is a type of photograph of the back of the eye to~          measure thickness of the retina.~        -  Fluorescein angiography and indocyanine green angiography. Pictures of the eye s blood~          vessels are taken using either a fluorescein or indocyanine green dye. The dye is~          injected into a vein in an arm and travels to the blood vessels in the eyes. A camera~          takes pictures of the dye as it flows through the blood vessels.~        -  Electroretinogram (ERG) to measure retinal function. The patient sits in a dark room for~          30 minutes with his or her eyes patched. Then, a small metal disk electrode is taped to~          the forehead, the eye patches are removed, the surface of the eye is numbed with eye~          drops, and contact lenses are placed on the eyes. The patient then watches flashing~          lights. The contact lenses sense small electrical signals generated by the retina when~          the light flashes.~   "
222420|NCT00647426|"~     This is an open-label, single institution, phase II study of Sorafenib in combination with~     docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and~     carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib~     twice a day on the 1st day of treatment and continue to take the medication every day until~     progression of disease, prohibitive toxicity, or patient withdrawal from the study.~     Chemotherapy courses will repeat every 21 days in the absence of disease progression or~     unacceptable toxicity for a total of four cycles.~   "
222421|NCT00647413|"~     Background: Infants are at risk for tobacco-attributable diseases by being exposed to~     environmental tobacco smoke (ETS). International literature has shown that a home smoking ban~     can reduce ETS. The purpose of this study is to examine whether a brief feedback about~     urinary cotinine in infants and a counselling session about the consequences of ETS leads to~     a reduction of ETS.~      All families with children up to an age of three years in the study region will be contacted~     by mail and asked for participation in this study. They will be randomised into an~     intervention and one control group. The intervention group will receive a ETS counselling~     session and detailed analysis of urinary cotinine (a biomarker of ETS) at their home. They~     will further receive written feedback approx. 2 weeks later. The control group will be~     visited and will answer a questionnaire and will receive brochures about ETS. They will~     receive a standard analysis feedback of urinary cotinine. There will be oine further~     assessment/ visit 12 months later. The outcome of this study is an anlysis of urinary~     cotinine and smoking behaviour and changes in cotinine and smoking behaviour.~   "
222425|NCT00647361|"~     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA~     delivers assist to spontaneous breathing based on the detection of the electrical activity of~     the diaphragm. We study the effect of NAVA on cardiac performance in critically ill,~     mechanically ventilated patients.~   "
222426|NCT00647348|"~     To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain~     atrophy, as measured by MRI, over a 2-year time-period when compared to placebo.~   "
222427|NCT00647335|"~     The purpose of this study is to look at genes (DNA) and how they affect health and disease.~     Genes are the instruction manual for the body. The genes you get from your parents decide~     what you look like and how your body behaves. They can also tell us a person's risk for~     certain diseases and how they will respond to treatment. We will collect a saliva sample for~     genetic research.~   "
222428|NCT00647322|"~     The primary aim of the study is to determine the effect of reducing the number and/or dose of~     anti epileptic drugs on an individual's quality of life and seizure control in people with~     difficult to control epilepsy and who are on polytherapy.~      This is a randomised trial so children will be divided into two groups, with reduction of~     anti epileptic drugs in the first group (withdrawal group) and no change to their medications~     in the second (control group). Irrespective of the group the child is assigned to (withdrawal~     group or control group), we will ask parents to complete several questionnaires on 2~     occasions: the first time will be immediately after the child enters the study (i.e. baseline~     assessment), and a second and last one will be 6 months after entering the study (i.e.~     follow-up assessment). These questionnaires aim to quantify aspects related with quality of~     life, AED side effects, seizure severity, and behaviour.~   "
222429|NCT00647309|"~     Elevated troponin is powerful and independent adverse prognostic marker in patient with ACS.~     However, non specific (non cardiac) troponin elevation is a common finding among hospitalized~     patients and worse prognosis too.~      The aim of this study is examine the prevalence of incidental cardiac troponin rise in a~     group of patient aged 65 and over admitted to geriatric department with hip fracture, and~     influence of troponin elevation on outcomes like ACS, death, motor and cognitive function.~   "
222430|NCT00647296|"~     This is a 2-part study of KNS-760704 in patients with ALS.~        -  Part 1 is a randomized, placebo-controlled, multi-center study to evaluate the safety,~          tolerability, and clinical effects of oral administration of 3 dosage levels of KNS~          760704 vs. placebo for 12 weeks.~        -  Part 2 is a randomized, double-blind, 2-arm, parallel group, extension study evaluating~          the safety, tolerability, and clinical effects of oral administration of 2 dosage levels~          of KNS-760704 for up to 76 weeks.~   "
222431|NCT00647283|"~     In liver transplantation up to 20% of recipients can completely discontinue immunosuppressive~     therapy maintaining normal graft function, and are conventionally considered as operationally~     tolerant. Discontinuation of immunosuppressive drugs in operationally tolerant recipients~     could lessen the side effects of chronic immunosuppressive therapy. However, this strategy~     results in the development of rejection in a high proportion of recipients who require~     lifelong immunosuppression. Thus, there is a need to identify predictive factors of~     successful drug withdrawal and to define the clinical and histological outcomes of~     operationally tolerant liver recipients.~      The main objective of this study is to establish the safety of attempting immunosuppressive~     (IS) drug withdrawal in stable liver transplant recipients, using standard clinical,~     biological and histopathological methods, to screen and follow-up patients, and to confirm~     the benefit of maintaining immunosuppressive drug interruption in patients who are tolerant~     to their liver transplant. The secondary objective of this study is to identify predictive~     factors of operational tolerance and to attempt to develop a multi-parameter decision rule~     to predict patient tolerance or non-tolerance in order to improve patient screening and~     follow-up. In a diagnostic observational sub-study, peripheral blood and liver tissue samples~     collected before immunosuppressive drug withdrawal will be employed to validate the~     diagnostic accuracy of a previously identified set of tolerance biomarkers and to identify~     potential new biomarkers capable of predicting the outcome of the immunosuppressive~     withdrawal protocol.~   "
222432|NCT00647270|"~     To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and~     demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of~     40 mg adalimumab every other week.~   "
222433|NCT00647257|"~     This is a an investigator-initial, multicenter, open-label, randomized, parallel-group~     comparative study to evaluate the effect on the incidence of AF and pacemaker dependence in~     SSS patients receiving physiological atrial-based pacing alone or adding losartan 100mg to~     physiological atrial-based pacing treatment. The duration of the study will be approximately~     13 months, comprising 4-week pre-study period, and 12-month treatment period.~   "
222434|NCT00647244|"~     To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in~     HIV-infected patients~   "
222435|NCT00647231|"~     The objective of this study is to characterize the analgesic properties of single dose study~     of HKT-500 in subjects with pain caused by mild to moderate OA of the knee~   "
222436|NCT00647218|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and~     radiation therapy before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells~     that remain after surgery.~      PURPOSE: This clinical trial is studying how well giving paclitaxel together with radiation~     therapy works in treating patients undergoing surgery for stage II or stage III breast~     cancer.~   "
222437|NCT00647205|"~     The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube® and~     T-SPOT.TB® for the diagnosis of latent tuberculosis in HIV infected antiretroviral naive~     patients: 80 originated from low TB prevalence countries, without any active TB; 80 HIV~     infected antiretroviral naïve patients originated from high TB prevalence countries, without~     any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with~     active TB.~   "
222438|NCT00647192|"~     The purpose of this study is to determine whether Eplerenone reduces atrial fibrillation (AF)~     recurrences within the first 8 weeks after electrical cardioversion of persistent AF.~   "
222440|NCT00647166|"~     To determine whether a combination of corticosteroids and azathioprine can achieve a higher~     remission rate and a lower subsequent relapse rate in patients with newly-diagnosed~     microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with~     polyangiitis (Churg Strauss syndrome) with no poor prognosis factor (FFS=0), and without~     significantly increasing the rate of adverse events, as compared to corticosteroids alone.~     The study hypothesis is a reduction of the absolute risk of treatment failure or relapse~     within the first 24 months following initiation of therapy of least 25%.~   "
222441|NCT00647153|"~     RATIONALE: Diagnostic procedures, such as immunoscintigraphy, using a radiolabeled monoclonal~     antibody may help find and diagnose colorectal cancer.~      PURPOSE: This clinical trial is studying how well immunoscintigraphy using a radiolabeled~     monoclonal antibody works in finding tumor cells in patients with colorectal cancer.~   "
222442|NCT00647140|"~     Medullary thyroid carcinoma (MTC) is a rare tumor arising from C cells of the thyroid gland~     and belonging to the endocrine tumors. 18F-DOPA PET, based on tha capacity of endocrine tumor~     cells to take-up, decarboxylate and store amino-acids, such 3-4-dihydroxyphenylalanine(DOPA),~     is used for imaging endocrine tumors. The aim of the study was to evaluate the contribution~     of 18F-DOPA whole-body PET for the detection of recurrences in patients with proven recurrent~     MTC without evidence of recurrence or metastases on several imaging modalities.~   "
222443|NCT00647127|"~     To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against~     experimental pain in skin, muscle and bone. The study will be performed with healthy~     volunteers.~   "
222444|NCT00647114|"~     Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.~   "
222445|NCT00647101|"~     The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure~     reduction in patients with ocular hypertension or open-angle glaucoma.~   "
222446|NCT00647088|"~     Pathophysiology of Aortic Valve Stenosis remains poorly known. The aim of the present study~     is to identify genetic factors involved in this disease using a case control trial design.~   "
222447|NCT00647075|"~     The purpose of this study is to assess the effects of a dietary supplement, the traditional~     Asian mushroom Yunzhi, as adjuvant in the treatment of patients with breast cancer.~   "
222448|NCT00647049|"~     The purpose of this study is to determine whether combined chemotherapy [rituximab plus high~     dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed~     by high dosage carmustin/thiotepa] followed by peripheral blood stem cell transplantation is~     effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL].~   "
222449|NCT00647036|"~     We hypothesise that the addition of glutamine supplementation to both parenteral nutrition~     and enteral feeds in surgical newborn infants leads to a reduction in bacterial invasion.~   "
222450|NCT00647023|"~     The incretin hormones are secreted from the gastrointestinal tract in response to nutrient~     ingestion, and are responsible for 70 % of insulin secretion in response to glucose. The~     incretin response is attenuated in subjects with type 2 diabetes and other conditions~     associated with insulin resistance. Polycystic ovary syndrome (PCOS) is characterised by~     irregular periods and increased androgen levels. It is the most common endocrine disorder~     amongst young women at fertile age, and the most common cause of female infertility. Insulin~     resistance plays an important role in the development of the disease, and women with PCOS are~     at increased risk of developing tyoe 2 diabetes. the incretin hormones have not previously~     been investigated in women with PCOS, and the purpose of the present study was to investigate~     the secretion of the two most important incretin hormones Glucose-like peptide-1 (GLP-1) and~     Glucose dependent insulinotropic peptide (GIP) during a three hour oral glucose tolerance~     test.~   "
222451|NCT00646997|"~     We aimed to demonstrate the impact of left atrial functions which were evaluated by three~     different echocardiographic modalities , on postoperative atrial fibrillation.~   "
222452|NCT00646984|"~     Aim: To assess the safety on the progression of HIV infection and the efficacy on the~     evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven~     strategies of intermittent treatment in chronically HIV-1-infected persons.~      Design: Pilot, prospective, open, randomized, controlled 3-year study.~      Setting and patients: University hospital. Patients with viral load <200 copies/mL and CD4~     cell count >450/mm3 for at least the last 3 months. Three arms with 50 patients each, that~     will be randomized either to continue antiretroviral therapy, or to discontinue it as long as~     either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3.~      Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral~     density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent~     with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA >200~     copies/mL while on therapy), immunological failure (CD4 cell count <200/mm3 while on~     therapy), or clinical failure (development of AIDS-defining illnesses); cost of~     antiretroviral therapy administered and time free of therapy in the arms assigned to~     intermittent treatment; and the evolution of T lymphocyte subpopulations and the development~     of proliferative and cytotoxic responses against HIV.~   "
222453|NCT00646971|"~     Patients with sleep apnea syndrome have repeated apneic events that induce periodic~     hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated~     generation of oxidants is associated with a dysfunction of the vascular endothelium that~     evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke,~     and myocardial infarction. The major aim of our study is to examine the effect of CPAP~     treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent~     vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.~   "
222454|NCT00646958|"~     The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an~     oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated~     skin and skin structure infections~   "
222472|NCT00646724|"~     The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal~     Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional~     Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation~     through the following mechanisms: protection of islet from inflammatory damage, immunological~     modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin~     and improve β-cell function.~   "
222455|NCT00646945|"~     In the oncology practice, The National Union of the Centres of Fight Against the Cancer~     recently published the Standards, Options and Recommendations for the coverage of the pains~     provoked during the invasive gestures of a short duration realized at patients affected by~     cancer. These support the use of the Kalinox ® 170 bar as therapeutic alternative for the~     preparation of the painful procedures of a short duration such as spinal taps or osseous at~     the adult.The objective of this study thus is to clarify the appropriate efficiency and the~     tolerance of the equimolar mixture protoxide of nitrogen / oxygen during invasive procedures~     realized in adult oncology with regard to the analgesic reference methods and to the effect~     placebo leads by the accompaniment of the patient during the procedure.~   "
222456|NCT00646932|"~     The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks~     (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3~     times a week for stable chronic renal failure.~   "
222457|NCT00646919|"~     We intend to take a nasal swab from each pediatric pre-operative patient in our out-clinic~     with the intention of looking for a connection between positive operative incisions and a~     positive nasal swab. The patients will be in the out-patient clinic for a few hours, and will~     be examined post-operatively after one week. Those with positive nasal swabs will be advised~     to apply a nasal cream (Mupirocin)in their noses for one week. Our hypothesis is that there~     is a correlation between positive nasal swabs and positive incision infections.~   "
222458|NCT00646906|"~     This research study investigates whether the ability of aspirin to reduce the risk of heart~     attacks may be diminished by the administration of acetaminophen. Patients who have heart~     disease are often prescribed aspirin because of its unique ability to permanently prevent~     platelets from aggregating and forming a blood clot. Such blood clots cause heart attacks~     when they form in a blood vessel that supplies the heart with oxygen rich blood. Some of~     these same patients also take acetaminophen everyday for relief from arthritis pain. Higher~     doses of acetaminophen may also have the ability to prevent the platelets from clotting,~     however only temporarily. Therefore, this study evaluates whether the timing of the~     administration of acetaminophen (before or after aspirin) interferes with the permanent blood~     clotting effects of aspirin.~      The primary hypothesis is that acetaminophen given two hours before aspirin will antagonize~     the effects of aspirin, while reversing the order of administration will not.~   "
222459|NCT00646893|"~     The objective of this study is to demonstrate that Preimplantation Genetic diagnosis will~     significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients~     of advanced maternal age (37-42) undergoing IVF. We would like to test this hypothesis by a~     randomized trial performed with the most suitable conditions using very successful IVF~     laboratories capable to perform the embryo biopsy under strict controlled conditions after~     proper training and validation of the techniques.~   "
222460|NCT00646880|"~     The purpose of this study is to compare the difference between tolterodine prolonged release~     (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is~     similar to propiverine with respect to micturition chart variables and safety profile.~   "
222461|NCT00646867|"~     To determine if Tetrix Cream, when applied to the skin lesions on patients with contact~     dermatitis, improves the symptoms of burning and itching.~   "
222462|NCT00646854|"~     The purpose of this study is to determine efficacy and safety of the monoclonal antibody~     MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma.~   "
222463|NCT00646841|"~     The primary objective was to determine the effects of the Gastrointestinal Therapeutic System~     (GITS) formulation of Doxazosin when used in combination therapy with the 5 major classes of~     antihypertensive agents as measure by 24-hour diastolic blood pressure.~   "
222464|NCT00646828|"~     Vascular and cardiac alterations are associated with aldosterone effects are evidenced in~     experimental models and aldosterone receptor blockade is of clear benefit in cardiac disease~     (heart failure). The study aims at assessing vascular and cardiac alterations in adults with~     a chronic increase in circulating aldosterone without hypertension. The investigated~     population will be patients with a rare disease, pseudohypoaldosteronism type 1, due to~     heterozygous inactivating mutations of the mineralocorticoid receptor.~   "
222465|NCT00646815|"~     The purpose of this study is to further characterize the treatment related changes in insulin~     sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with~     growth hormone deficiency (GHD).~   "
222466|NCT00646802|"~     Eligible patients will be informed and asked to enroll in the study at hospital admission. A~     transvaginal ultrasound examination will be performed to determine cervical length. If an~     eligible woman accepts to participate, patient will be randomized to one of the study arms~     assigned in a double blind basis. Patient will receive the medication (vaginal capsule of~     progesterone or placebo). The patient will administer herself one vaginal capsule in a daily~     basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate~     that the use of a maintenance treatment with vaginal progesterone is able to reduce the~     incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal~     and neonatal data will be collected.~   "
222467|NCT00646789|"~     To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent~     mild-to-moderate asthma patients to permit further clinical investigation.~   "
222468|NCT00646776|"~     The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered~     with atazanavir and ritonavir (ATV/RTV)~   "
222469|NCT00646763|"~     The purpose of this study is to determine whether or not the injection site of cytokines, or~     growth factors, has an effect on peripheral blood stem cell collection.~   "
222470|NCT00646750|"~     To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin)~     administration in the conditioning treatment of patients with refractory large B-cell diffuse~     lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem~     cells.~   "
222471|NCT00646737|"~     The purpose of this study is to evaluate the safety and the tolerability of the substitution~     of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable~     renal transplant patients in Brazil, in a treatment regimen of immunosuppressants with~     tacrolimus and mycophenolate mofetil.~   "
222473|NCT00646711|"~     To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets~     to Depakote ER tablets in the pediatric population.~   "
222474|NCT00646698|"~     Context: Upper body obese (UBO) subjects are more likely to develop cardiovascular disease~     (CVD) than lower body obese (LBO) or lean. This may in part be caused by greater hepatic~     secretion of very-low-density-lipoprotein-triglycerides (VLDL-TG).~      Objective: To assess the impact of body composition and insulin sensitivity on basal VLDL-TG~     turnover in women.~   "
222475|NCT00646685|"~     The purpose of this study is to empirically determine whether one of 2 surgical techniques~     commonly used for bile duct reconstruction during living donor liver transplantation results~     in fewer biliary complications. Also, this study may identify patient group(s) that~     particularly benefit from a particular technique.~   "
222476|NCT00646672|"~     This study will determine the risk of brain aneurysm (abnormal outpouching of a brain artery)~     in young adults who had their carotid artery tied off as an infant as part of the~     extracorporeal membrane oxygenation (ECMO) procedure. This procedure is sometimes performed~     on newborns with lung problems so that they can have oxygen brought to their blood outside~     the body. ECMO operates similar to a heart-lung machine. Blood drained from the veins has the~     carbon dioxide removed and oxygen added. The oxygenated blood is then returned to the body~     through the arteries.~      People 18 to 25 years of age who underwent ECMO as an infant at the Children's National~     Medical Center in Washington, D.C., may be eligible for this study.~      Participants undergo the following procedures:~        -  Medical history and physical and neurological examinations.~        -  Magnetic resonance imaging (MRI) of the head and neck. MRI uses a strong magnetic field~          and radio waves to obtain images of body organs and tissues. The subject lies in the~          scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, lying~          still for up to 15 minutes at a time. During part of the procedure, a contrast dye is~          injected into a vein through a catheter (thin plastic tube) to enhance the images.~   "
222477|NCT00646659|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth~     of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high energy x-~     rays to kill tumor cells. Cetuximab may also make tumor cells more sensitive to radiation~     therapy. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. It is not yet known which~     regimen of radiation therapy, combination chemotherapy, and cetuximab and is most effective~     in treating patients with head and neck cancer.~      PURPOSE: This randomized phase II trial is comparing two different regimens of radiation~     therapy given together with combination chemotherapy and cetuximab to see how well they work~     in treating patients with newly diagnosed stage III or stage IV head and neck cancer that~     cannot be removed by surgery.~   "
222478|NCT00646646|"~     The purpose of this study is to determine whether sedation affects saccadic eye movements.~   "
222479|NCT00646633|"~     Based on the investigators clinical experience in patients with chronic disease (Hui, Hui,~     and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui~     2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a~     pilot study that investigates if acupuncture combined with patient education will relieve~     fatigue in patients who have completed primary treatment for breast cancer.~   "
222480|NCT00646620|"~     The purpose of this study is to compare the early onset of effect of Symbicort compared to~     Advair Diskus and Ventolin in adults with asthma~   "
222481|NCT00646607|"~     This project consists of two independent, following specific eligibility criteria and~     different randomisation schemes studies, later on called DURATION study and BEV study. Once~     randomised in the duration study, patients fulfilling eligibility criteria for BEV study may~     also be randomized to receive BEV or no BEV, in addition to FOLFOX-4 chemotherapy.~      As both are open label studies, there will be no blinding of treatment assignment.~   "
222482|NCT00646594|"~     The purpose of this study is to determine whether Symbicort compared with Advair, will be~     more effective in controlling asthma in adults and adolescents.~   "
222483|NCT00646581|"~     The purpose of the study is to find out how a small dose of insulin might affect memory, the~     ability to concentrate, and improve your daily functioning in patients with schizophrenia and~     schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The~     investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal~     insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's~     effect on cognition. The specific aims include:~        1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on~          cognitive functioning, including attention and memory.~        2. Examine whether single dose of intranasal insulin administration will raise serum~          insulin level and decrease plasma glucose level~      Insulin will be delivered through an air spray pump into your nose. The investigators will be~     comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.~   "
222484|NCT00646568|"~     In an era of delayed fertility plans, there is an increasing need for a reliable method to~     predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B,~     Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and~     number of antral follicles are non-specific and with questionable reliability. The~     biochemical tests represent the function of production of androgens, as a predictor of~     ovarian reserve, has not been tested yet.~      Working hypothesis and aims: testing the prognostic capability of hCG stimulating test of~     theca cells for estimating the ovarian reserve, and by that to calculate better the chance~     for IVF cycle success~   "
222537|NCT00645879|"~     The objective of this project is to define whether nutritional supplements (ornithine~     alpha-ketoglutarate, glutamine, or citrate) capable of filling-up the citric acid cycle~     (anaplerotic therapy) can improve hyperammonemia, glutamine levels, and outcome in patients~     with propionic acidemia. Ornithine alpha-ketoglutarate, glutamine, and citrate are commonly~     used as nutritional supplements specially by athletes to increase muscle strength. They can~     be mixed with formula or other foods.~   "
222593|NCT00645138|"~     The purpose of this project is to determine if there is a difference between paravertebral~     block and general anesthesia in terms of time to discharge from the Post-Anesthesia Care Unit~     and pain level in patients undergoing outpatient breast cancer surgery.~   "
222485|NCT00646555|"~     This study, conducted by the NCI and the George Washington University Medical Center (GWUMC),~     will examine breast tissue from patients with inflammatory breast cancer (IBC) for tumor~     markers and factors associated with angiogenesis. Angiogenesis is the formation of new blood~     vessels that is essential for tumor growth and spread. IBC is an extremely rare, aggressive~     form of breast cancer that disproportionately affects young women. The risk factors for IBC,~     its cause, and how it develops are unknown, but the disease appears to involve a high degree~     of angiogenesis.~      Tissue specimens for this study will be obtained from GWUMC's Inflammatory Breast Cancer~     Registry and Biospecimen Repository. The registry was established to develop a national~     registry of patients with IBC that includes standardized clinical, epidemiological, and~     pathological information, along with disease recurrence and survival data.~      For this study, tissue specimens from the repository will be tested for biological markers~     and angiogenesis parameters to help in the classification of the tumors. Biological markers~     (such as estrogen receptor, progesterone receptor, the p53 gene, and others) and angiogenesis~     parameters (such as various proteins involved in vessel formation) will be examined to~     determine their prevalence in tissue specimens and their relationship to patient survival.~     When possible, the findings will be compared with non-IBC tissue samples.~   "
222486|NCT00646542|"~     This clinical trial is designed to provide additional information on the safety and~     tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2~     diabetes mellitus (T2DM) and moderate or severe renal insufficiency.~   "
222487|NCT00646529|"~     The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in~     asthmatic children aged 6 to 11 years~   "
222488|NCT00646516|"~     The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will~     improve lung function and symptoms of adults and adolescents with asthma.~   "
222489|NCT00646503|"~     This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.~   "
222490|NCT00646490|"~     Key words : serum, pleural effusion, procalcitonin, pneumonia Pneumonia is the common cause~     of pleural effusion (ranged 2nd) and bacterial infection is the main etiology of pneumonia.~     Procalcitonin, the prohormone of calcitonin, is a 116 amino-acid protein produced by C-cell~     of the thyroid gland. During severe infection, procalcitonin is probably produced by~     extra-thyroid tissues and the concentration increased rapidly in bacterial infection but~     remains low in viral infections. However, the exact origin and pathophysiological role of~     procalcitonin during sepsis is not clear and it is not a marker of infection as such, since~     localized infections or infections with no systemic manifestation cause a little if any~     increase in procalcitonin levels. This study will focus on assessing the value of~     procalcitonin in pleural effusion for diagnosis, severity and prognosis among~     community-acquired pneumonia with pleural effusion, such as in serum. 100 patients with~     clinical pneumonia infection score over six points diagnosed of community-acquired pneumonia~     and proved to have pleural effusion by chest sonography on admission will be studied~     prospectively. Serum and effusion procalcitonin levels will be measured initially and 3 days~     later after medical therapy. Bacterial pneumonia will be identified if bacteria was cultured~     from any one of the three kinds of specimen, including blood, pleural effusion or~     bronchoalveolar lavage. Then we will divide one hundred of patients into bacterial or~     non-bacterial groups. Finally, we will analyze demographic and procalcitonin data of serum~     and pleural effusion between these two groups and compare the difference between the severe~     or mild and response or non-response bacterial community-acquired pneumonia statistically.~      The aim of the study will be to verify whether procalcitonin levels measured in the serum and~     pleural effusion could serve as a predictor for bacterial community-acquired pneumonia with~     pleural effusion and the different levels will also be indicative of severity and prognosis.~     We hope that the predictor from pleural effusion will be more sensitive or specific than that~     from serum and could be detectable in localized bacterial infection.~   "
222491|NCT00646477|"~     The study is a prospective field evaluation to assess the therapeutic value of the~     CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.~      Precisely, the study was designed to :~        -  evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep~          quality and normalozing respiratory events~        -  determine the sensitivity and specificity of the device in adequately detecting~          respiratroy events~        -  compare effective pressure Peff determined by the device and during manual titration~        -  compare the impact of the two-speed descent pressure algorithm~   "
222492|NCT00646464|"~     Computerized continuous performance tests (CPT) considered the gold standard for diagnosis~     of Attention Deficit/Hyperactivity Disorder (ADHD.~      This type of tests are based mainly on visual performance. The available tests suffer from~     high false negative errors. This raises questions regarding their ability to correctly~     diagnose ADHD.~      With the expanding knowledge regarding the neurobiological basis in ADHD we have learned that~     attention is not a general property of the whole brain, but involves several coordinated~     networks. This knowledge promoted us to the stage in which we can recognize different types~     of attention domains.~      Our diagnosis test can separate between the different attention abilities and provide~     specific diagnosis. Our program is individually fits for the specific child difficulties and~     covers a wider range of needs. So, it can be helpful to a larger variety of children with~     different needs.~   "
222493|NCT00646451|"~     Pregabalin is approved for the treatment of nerve pain as well as an additional therapy in~     the treatment of seizures. In December 2004, Pfizer gained Food and Drug Administration (FDA)~     approval for use of pregabalin in nerve pain associated with diabetes and shingles; making it~     the first FDA-approved treatment for both of these nerve pain states.~      Tremor is uncontrolled trembling in part of the body. Essential tremor (ET) is associated~     with purposeful movement(e.g., holding a glass to drink, shaving, writing and buttoning a~     shirt). It occurs most often in the hands and head and also may affect the arms, voice box~     (larynx), trunk, and legs. ET is caused by abnormalities in areas of the brain that control~     movement. It usually does not result in serious complications.~      ET affects approximately 5 million people in the United States. Incidence is highest in~     people over the age of 60.~      ET usually develops gradually during middle age or later in life. Symptoms may remain mild or~     become more severe over time. Stress, fatigue, anxiety, and hot or cold weather can worsen~     the disorder. Severe tremor may cause difficulty doing activities of daily living, such as:~        -  Brushing hair and teeth~        -  Holding a glass without spilling~        -  Performing self-care (e.g., getting dressed, shaving, putting on makeup)~        -  Using eating utensils~        -  Writing and drawing~      The purpose of this study is to examine the tolerability and efficacy of Pregabalin in~     patients with ET .~      In other words, can patients diagnosed with ET tolerate high dose of pregabalin? Will the~     pregabalin be considered as an efficient medicine in the treatment of ET?~   "
222538|NCT00645866|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin, docetaxel, and capecitabine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving epirubicin together with~     docetaxel and capecitabine and to see how well it works in treating women with stage IIIA or~     stage IIIB breast cancer.~   "
222494|NCT00646438|"~     Standard care for patients with diabetes having CABG surgery at Providence St. Vincent~     Medical Center includes strict control of blood sugar (glucose) levels for 3 days after~     surgery. This is done through frequent monitoring of blood sugar levels and by giving insulin~     continuously through a needle into a vein (intravenously). This intensive glucose control has~     resulted in fewer complications such as serious infections and death, and has shortened the~     length of the hospital stay for patients.~      This study treatment is different from standard treatment in that it extends the intensive~     glucose control beyond the third postoperative day to one full year. Once discharged from the~     hospital following the CABG procedure, the intense glucose control is done using subcutaneous~     insulin (a shot under the skin), oral medications, and by measuring blood sugar levels~     frequently.~      The purpose of this study is to see how safe and effective strict glucose control is when~     extended beyond 3 days and hospital discharge for one year. Another purpose is to see how~     well patients can comply with the daily management of intensive glucose control for one-year~     as well as the study follow-up schedule.~   "
222495|NCT00646425|"~     The objective of this trial is to assess if treatment with basiliximab allows subjects to~     taper off other immunosuppressive drug regimens without causing an increase in their uveitis.~   "
222496|NCT00646412|"~     The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent~     post-surgical adhesions after median laparotomy.~   "
222497|NCT00646399|"~     Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing~     staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior~     to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study~     days 0, 1, 2, 9, 16, and 23.~   "
222498|NCT00646386|"~     Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody~     Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis~   "
222499|NCT00646373|"~     The objective of this study is to evaluate the impact of reduced pump prime on blood~     transfusions and postoperative complications in patients at high risk of severe hemodilution~     during CPB.~      HYPOTHESIS The use of a new CPB circuit with a smaller internal volume, together with~     retrograde autologous priming of the lines (RAP) will allow a smaller prime volume and~     therefore less significant hemodilution on pump.~      EXPERIMENTAL DESIGN Overview~      Patients will be randomized on the morning of surgery to one of the two study groups in a 1:1~     allocation scheme:~        1. Low pump prime~        2. Standard pump prime Outcomes The primary outcome is the number of units of blood~          products transfused within the first 24 hours post CPB.~   "
222500|NCT00646360|"~     Our research is about the significance of polyunsaturated fatty acids (PUFAs) for human~     development. Specifically, we will assess the effect of docosahexanoic acid (DHA)~     supplementation during pregnancy on infant growth and development through a randomized~     controlled intervention trial in Cuernavaca, Mexico. This is a collaborative effort between~     the Rollins School of Public Health, Emory University, the Instituto Nacional de Salud~     Publica (INSP) and the Instituto Mexicano del Seguro Social (IMSS), Cuernavaca, Mexico.~     Pregnant women attending the IMSS General Hospital I are recruited between 18-22 wks~     gestation and assigned randomly to receive either DHA (400 mg) or a placebo daily until~     delivery. The main study outcomes include a) birth outcomes: birth size, gestational age,~     cord blood levels of DHA and neurodevelopment b) maternal blood and breast milk DHA levels at~     1 and 3 mo post-partum) c) postnatal growth and development during the first 5 years of age~     and d) infant DHA status at 3, 12 and 18 mo. All data collection is carried out at the study~     headquarters (IMSS) except for home environment that is assessed during home visits. Physical~     growth (length, weight, and head circumference) and infant and child development (visual and~     auditory evoked potentials, visual attention, Bayley scales of infant development, McCarthy~     child development score, Hearts and Flowers stroop test, and other computerized child~     development tests) are measured at birth, 1, 3, 6, 9, 12, 18, 24, 36 mo and at 4 and 5 years~     of age by trained workers. Data are also obtained on socioeconomic status, obstetric history,~     maternal diet, anthropometry and intelligence, quality of home environment and infant feeding~     practices. Data analysis will include group comparisons (intent-to-treat) after ensuring~     effectiveness of randomization, and structural equation modeling to examine the various~     pathways by which DHA supplementation during pregnancy affects child growth and development.~     The findings of this project will contribute significantly to our understanding of the~     functional consequences of DHA supplementation during pregnancy.~   "
222501|NCT00646347|"~     The implementation of Neuro Hand Orthosis Upper Limb Program can significantly improve the~     severe stroke paralytic arm in subacute rehabilitation as compared with the use of~     conventional therapy.~   "
222502|NCT00646334|"~     Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The~     primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is~     superior to Ultrapro® Mesh in incisional hernia repair in matter of the physical function~     score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include~     the patient's daily activity, the rating of patients pain and the wound assessment determined~     on several occasions during the six months observation time.~   "
222503|NCT00646321|"~     The purpose of this study is to compare Symbicort with budesonide alone for the treatment of~     asthma in children aged 6 to 15 years~   "
222504|NCT00646308|"~     The purpose of this study is to determine if patients with a history of nonsecreting~     pituitary adenomas with untreated GH deﬁcient patients have proﬁles consistent with increased~     cardiovascular risk compared to patients without GH deficiency who have undergone similar~     surgery.~   "
222511|NCT00646217|"~     Most stroke survivors return home, where their care is supported by family and friends.~     Although family caring at home is usually rewarding, it is often challenging, too. The~     demands and responsibilities of caring for a loved one at home can be stressful. The actual~     activities of caregiving vary according to the needs of the stroke survivor, but can include~     helping with bathing, dressing, eating, and many other activities. Caregivers must learn care~     techniques and how to manage changes in roles and lifestyle. While adjusting to these~     changes, caregivers may be advised to 'take care' of themselves, but may not receive guidance~     or support for doing this. In this study, we are testing a self-care intervention for older,~     spouse caregivers of persons with stroke to see how helpful the intervention is in reducing~     distress and in helping caregivers adopt and maintain healthy lifestyle behaviors.~      We have developed an intervention for caregivers that is called Self-Care TALK. The~     intervention includes creating a health-promoting, self-care education and support~     partnership between caregivers and nurses through the use of weekly telephone conversations.~     Each conversation focuses on a health-related topic, such as: healthy habits, building~     self-esteem, focusing on the positive, avoiding role overload, communicating, and building~     meaning. The conversations follow a basic format, but also are unique to each person.~     Participants complete questionnaires before and after the intervention, so that we can test~     the effect of participation in Self-Care TALK on caregiver health.~      We know that education and support about self-care can be achieved through partnerships~     between family caregivers and health care professionals. Our goal is to build on this~     knowledge in testing whether participation in the Self-Care TALK intervention will result in~     less distress and better health and well-being for spouse caregivers, compared to caregivers~     who receive no additional care beyond usual education and support. In working toward this~     goal, we are using a partnership approach, in which nurses and caregivers discuss several~     health-related topics and mutually identify creative solutions for caregivers to incorporate~     self-care and health-promotion strategies into their daily routines. Promoting healthy~     outcomes for caregivers is essential to supporting their personal well-being, and to~     fostering their ability to continue home care for their loved one.~   "
222505|NCT00646295|"~     Thyroid related orbitopathy (TRO) is an autoimmune disease. Clinical features include:~     orbital pressure pain, ocular soft tissue swelling, muscle enlargement around the eyeball,~     eyelid retraction and bulging of the eye anteriorly out of the orbit. In many cases, the~     cornea may become too dry, and as a result, corneal ulcers may form, which can become~     infected. In severe cases, damage to the optic nerve can occur secondary to optic nerve~     compression by enlarged muscles in the orbit.~      Inflammation with soft tissue swelling occurs in the 1st stage of the disease. Scar formation~     can occur in the 2nd phase. The muscles under and nasal to the eyeball are most commonly~     involved. In many patients, intra-ocular pressure (IOP) can increase in primary. IOP in~     upgaze (when looking up) can increase.~      Goldmann applanation is the standard device to measure the IOP. It measures the average IOP~     (between the systolic, when the heart contracts, to the diastolic IOP, when the heart~     relaxes). Pascal Dynamic Contour Tonometer is a new device that can measure IOP and ocular~     pulse amplitude (OPA) which is the difference between diastolic IOP and systolic IOP. The~     choroid is a vascular layer inside the eyeball that feeds part of the retina (the retina is~     like the film in a non-digital camera). OPA is suggestive of choroidal blood flow. IOP~     measurements using Pascal Dynamic Contour Tonometer are less influenced by corneal thickness~     as opposed to Goldmann applanation which measures higher values in thicker corneas. In the~     current study we are interested in measuring the relationships between measurements taken~     with Goldmann applanation (IOP) and those taken with the Pascal Dynamic Contour Tonometer~     (IOP and OPA). In addition, we will investigate the effect of orbital muscle enlargement on~     IOP/OPA following an up gaze position (looking up).~   "
222506|NCT00646282|"~     Patients with kidney failure on dialysis can be successfully transplanted. However, many of~     them do not attain a normal kidney function and/or present a slow deterioration of kidney~     function after transplantation. As a consequence, they can develop an endocrine disorder~     called hyperparathyroidism, which can cause bone disease and a high risk of bone fractures.~     In spite of the known bone disease and hyperparathyroidism, there is no well defined~     treatment for these patients.~      Moreover, kidney transplant recipients present a higher mortality rate compared to the~     general population, and the principal cause of death is cardiovascular disease. Dialysis~     patients are known to have extensive cardiovascular calcifications and increased vascular~     stiffness, and these factors have been closely associated with cardiovascular mortality.~      The effect of vitamin D on bone health is well known in the general population. Many studies~     showed a reduction in fracture rate in post-menopausal women and older men receiving vitamin~     D and calcium supplements. Vitamin D analogues are also commonly used to treat~     hyperparathyroidism in dialysis patients. Finally, vitamin D has been suggested to have~     beneficial effects on the cardiovascular system and to reduce mortality in dialysis patients.~      Hectorol® is a vitamin D analog which has been demonstrated to effectively treat~     hyperparathyroidism in dialysis and pre-dialysis patients.~      The effects of vitamin D supplementation on bone disease, hyperparathyroidism and~     cardiovascular function in kidney transplant recipients have not been properly studied.~      Whether Hectorol® therapy helps reducing the severity of bone disease and improving vascular~     function in kidney transplant recipients is still unknown.~   "
222507|NCT00646269|"~     ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact~     of cognitive training, reminiscence therapy and a made-to-measure program on the~     progression rate of dementia.~   "
222508|NCT00646256|"~     The aim of the study is to examine whether the efficacy of psychoeducation in patients with~     schizophrenia or schizoaffective disorders is dependent on their cognitive performance level~     and if a preceding cognitive training can enhance the therapeutic effects of psychoeducation~   "
222509|NCT00646243|"~     Background. Clinical benefits of cardiac resynchronization therapy (CRT) have been clearly~     demonstrated in heart failure (HF) patients with severe left ventricular (LV) dysfunction and~     wide QRS at surface electrocardiogram. However, there is a growing evidence that QRS duration~     poorly predicts responses to CRT, and that ~30% of patients do not experience any benefit~     from CRT when pre-implant dyssynchrony is defined according to electrocardiographic criteria.~     A number of echocardiographic criteria have been proposed to assess mechanical LV~     dyssynchrony, but at present there is no consensus on their use to predict response to CRT.~      Study Design. The Italian Multicenter PROject on echo assessment of left VEntricular~     (IMPROVE) dyssynchrony study is a prospective, multicenter, observational study aimed to~     assess feasibility and predictive power of mechanical dyssynchrony assessed by~     echocardiography in consecutive consenting patients candidate to CRT by clinical and~     electrocardiographic criteria. IMPROVE will enroll 120 healthy subjects and 216 HF patients~     in 6 sites in Italy. CRT response criteria will be based on improvement in NYHA class and LV~     reverse remodeling evaluated by 3D-echocardiography. Enrollment is expected to conclude early~     2009.~      Implications. CRT is today part of the therapeutic armamentarium for symptomatic HF patients~     refractory to medical therapy, with wide QRS complex and severe LV systolic dysfunction. The~     IMPROVE study has been designed to evaluate reference values of indexes of ultrasound~     mechanical dyssynchrony that have been proposed in the literature and compare their ability~     to predict response to CRT in HF patients.~   "
222510|NCT00646230|"~     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of intravenous~     fenretinide in treating young patients with recurrent or resistant neuroblastoma.~   "
222512|NCT00646204|"~     To evaluate the effects of Memantine on non-motor symptoms in patients with Parkinson's~     disease.~      Parkinson's disease (PD) affects about one million people in the United States. It is a~     common neurological condition that is clinically defined by rigidity (muscle stiffness),~     bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals~     numerous non-motor symptoms that have been underemphasized. Problematic symptoms include~     varying degrees of dementia, psychosis, diminished assertiveness and confidence, general~     fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder,~     and a common yet difficult to define sense of not feeling well.~   "
222513|NCT00646191|"~     Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic~     Plaque Psoriasis~   "
222514|NCT00646178|"~     Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to~     Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying~     anti-Rheumatic Drug Therapy~   "
222516|NCT00646152|"~     This study will examine the safety of an experimental medication called Poly-ICLC, developed~     for preventing or reducing the severity of infections from influenza and other viruses~     acquired through the nose, mouth and lungs. The study is divided into two parts, in which~     Poly-ICLC is tested at different dose levels.~      Healthy people between 18 and 70 years of age who have no chronic medical problems may be~     eligible for this study. Participants undergo the following procedures:~      Part I~        -  Up to 7 days before Poly-ICLC administration: Medical history, physical examination and~          blood tests.~        -  Day 1: Nasal wash and Poly-ICLC administration. A small amount of salt water is placed~          into the front of the nose and then suctioned out. Poly-ICLC is then squirted into each~          nostril, one after the other, at a dose of 0.25, 0.5 or 1 mg. A small number of subjects~          are given a placebo (a solution with no active ingredient.) Subjects are observed in the~          clinic for 30 minutes after treatment.~        -  Day 2: Subjects receive a second nasal wash and repeat blood tests. They keep a diary~          card for 1 week, recording any drug side effects.~        -  Day 5: Subjects have repeat blood tests and a review of their diary card. The keep a~          diary card for another 3 weeks.~        -  Day 12: Subjects are contacted by phone to review their diary card.~        -  Day 28: Subjects are contacted by phone to review their diary card.~      Part II~        -  Up to 7 days before Poly-ICLC administration: Medical history, physical examination and~          blood tests.~        -  Day 1: Nasal wash and Poly-ICLC administration. Same as above for Part I participants.~        -  Day 3: Subjects receive a second dose of medication and are observed again for 30~          minutes.~        -  Day 4: Subjects receive a second nasal wash and repeat blood tests. They keep a diary~          card for 1 week, recording any drug side effects.~        -  Day 7: Subjects have repeat blood tests and a review of their diary card. The keep a~          diary card for another 3 weeks.~        -  Day 14: Subjects are contacted by phone to review their diary card.~        -  Day 28: Subjects are contacted by phone to review their diary card.~   "
222517|NCT00646139|"~     RATIONALE: KX2-391 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of KX2-391 in treating~     patients with advanced solid tumors or lymphoma that did not respond to treatment.~   "
222518|NCT00646126|"~     The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry~     season in areas of seasonal malaria transmission. Targeting this parasite reservoir before~     the transmission season could be a good strategy for malaria control. We are conducting a~     randomized double blind placebo controlled mass drug administration trial in eight village to~     clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in~     eastern Sudan.~   "
222519|NCT00646113|"~     To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant~     when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary~     hypothesis is that implant survival after 5 years is equal to what has been observed with~     comparable implants in current literature.~   "
222520|NCT00646100|"~     Transcatheter arterial chemoembolization (TACE) had been proved to improve the survivals for~     middle stage hepatocellular carcinoma (HCC), but for advanced stage HCC its' efficacy had not~     been proved. The investigators hypothesize that TACE also improve the survivals for advanced~     stage HCC. Thus, the investigators carried out this prospective control study to find out if~     the survivals for patients after TACE better than only best support or not.~   "
222521|NCT00646087|"~     Depression is a wide spread illness. Depression contributes most significantly to national~     health care costs. While the number and types of treatments used for depression have expanded~     over the years, even with an increased range of options, the response rate, defined as the~     number of subjects who have a 50% reduction in depressive symptoms, is estimated to be around~     65%.~      This randomized clinical trial will examine the frequency of treatment with ketamine in~     patients with treatment-resistant depression TRD without psychosis. It will compare two modes~     of the ketamine treatment; every other day ketamine, versus two active and four placebo~     treatments over the period of 12 days.~   "
222522|NCT00646074|"~     Most individuals with Alzheimer's or dementia return home, where their care is supported by~     family and friends. Although family caring at home is usually rewarding, it is often~     challenging, too. The demands and responsibilities of caring for a loved one at home can be~     stressful. The actual activities of caregiving vary according to the needs of the individual,~     but can include helping with bathing, dressing, eating, and many other activities. Caregivers~     must learn care techniques and how to manage changes in roles and lifestyle. While adjusting~     to these changes, caregivers may be advised to 'take care' of themselves, but may not receive~     guidance or support for doing this. In this study, we are testing a self-care intervention~     for older, spouse caregivers of persons with Alzheimer's or dementia to see how helpful the~     intervention is in reducing distress and in helping caregivers adopt and maintain healthy~     lifestyle behaviors.~      We have developed an intervention for caregivers that is called Self-Care TALK. The~     intervention includes creating a health-promoting, self-care education and support~     partnership between caregivers and nurses through the use of weekly telephone conversations.~     Each conversation focuses on a health-related topic, such as: healthy habits, building~     self-esteem, focusing on the positive, avoiding role overload, communicating, and building~     meaning. The conversations follow a basic format, but also are unique to each person.~     Participants complete questionnaires before and after the intervention, so that we can test~     the effect of participation in Self-Care TALK on caregiver health.~      We know that education and support about self-care can be achieved through partnerships~     between family caregivers and health care professionals. Our goal is to build on this~     knowledge in testing whether participation in the Self-Care TALK intervention will result in~     less distress and better health and well-being for spouse caregivers, compared to caregivers~     who receive no additional care beyond usual education and support. In working toward this~     goal, we are using a partnership approach, in which nurses and caregivers discuss several~     health-related topics and mutually identify creative solutions for caregivers to incorporate~     self-care and health-promotion strategies into their daily routines. Promoting healthy~     outcomes for caregivers is essential to supporting their personal well-being, and to~     fostering their ability to continue home care for their loved one.~   "
222523|NCT00646061|"~     Renal colic is very common in emergency department patients. Our aim of this study is which~     combination of drug is more effective in renal colic.~   "
222524|NCT00646048|"~     This study was a prospective observational study examined the safety of the TriVascular AAA~     Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms.~     Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System,~     evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired~     location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to~     exclude the abdominal aortic aneurysm.~   "
222525|NCT00646035|"~     To determine the safety and efficacy of paricalcitol capsules as compared to placebo for~     treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone~     levels in end stage renal disease subjects on peritoneal dialysis.~   "
222539|NCT00645853|"~     The purpose of this study is to provide safety and tolerability data for AZD0837 during~     long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one~     or more additional risk factors for stroke and systemic embolic events (moderate to high risk~     patients).~   "
222540|NCT00645840|"~     The purpose of this study is to determine whether control of inflammatory pathways mediated~     by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in~     expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in~     children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1~     beta pathways will be associated with preserved insulin secretory capacity.~   "
222572|NCT00645411|"~     The present study is the first study designed to evaluate safety, tolerability and~     immunogenicity of the cell culture-derived influenza vaccine in healthy children and~     adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and~     safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to~     enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3~     to 8 years of age (Cohort 3).~   "
222526|NCT00646022|"~     This study will evaluate members in families with a history of small bowel carcinoid cancer~     to study the natural history of those family members that have the disease, determine ways to~     improve early detection by performing surveillance on those at risk but without disease and~     to identify the gene(s) that may cause the tumors. Familial carcinoid tumors usually~     originate in hormone-producing cells that line the small intestine or other cells of the~     digestive tract. The tumors are slow-growing and usually take many years before they cause~     symptoms. It is known that these tumors occur more often in some families and are then passed~     from one generation to the next by inherited genes.~      Members of families, including all siblings and offspring in which two or more immediate~     blood relatives have had small bowel carcinoid tumors are eligible for this study. In some~     cases unaffected spouses of family members diagnosed with carcinoid cancer are also requested~     to participate by donating a sample of blood only.~      Participants undergo a medical evaluation every 3 years during a 3- to 5-day hospital stay at~     the NIH Clinical Center. All participants have a personal and family medical history obtained~     and undergo a physical examination, blood and urine tests.~      People who already have a small bowel carcinoid tumor or are at risk of developing a~     carcinoid tumor have some or all of the following procedures to determine the presence of~     carcinoid tumor and its (omit next two words- location or) spread to other areas of the body:~        -  Video Capsule Endoscopy: Visualization of the gastrointestinal tract by ingesting a~          disposable, vitamin-pill sized video capsule that has its own camera and light source.~        -  CT of the chest abdomen and pelvis with oral and IV contrast : X-ray examination of the~          chest, abdominal and pelvis organs.~        -  18 FDOPA Positron emission tomography (PET) with CT for localization: Nuclear imaging~          scan to look at tumor activity.~        -  MRI Liver with contrast - to determine if disease has spread to liver~        -  Gallium 68 PET/CT-limited to individuals that have residual tumor.~        -  Clinical and research blood work~      Should mid gut carcinoid tumors be found every participant will be assisted in determine what~     the best course of treatment will be for them.~   "
222527|NCT00646009|"~     The purpose of this study is to compare the early onset of effect of Symbicort compared to~     Advair Diskus and Ventolin in adults with asthma~   "
222528|NCT00645996|"~     Background: It is well established that the presence of bacteria in the intestine has a~     profound influence on health. Probiotics, (beneficial bacteria) have shown ameliorating~     effects on various infectious diseases. The influence of probiotics on several~     immune-mediated conditions has also been investigated, among them, atopic dermatitis (Asthma~     of the skin), and milk allergy.~      The precise mechanism of action of probiotics is not fully understood. Several animal and~     human studies have shown the probiotic bacteria to influence the immune system. The aim of~     the present study is to evaluate whether supplementing the diet with oral probiotics affects~     the immune response of children following routine vaccination against 4 common childhood~     viral diseases: Mumps, Measles, Rubella and Varicella.~      Objective(s) and Hypothesis(es):~      Hypothesis: Administration of probiotics will increase the amount of antibodies produced~     following vaccination for Measles, Mumps, Rubella and Varicella, by over 15%.~      Objectives:~        -  To determine whether administration of probiotics during infancy influences antibody~          levels following the routine childhood vaccinations.~        -  To determine whether administration of probiotics during infancy influences the rate of~          adverse effects following the routine childhood vaccinations.~      Potential Impact: Vaccines, alongside with the discovery of Penicillin, have been cited as~     the great public health successes of the 20th century. However, even in countries with~     maximal childhood immunization coverage, the protective effect is not optimal. For example,~     only 70% to 90% of children immunized against chickenpox are actually protected against the~     disease. If we succeed in raising these numbers, even by a single percent, it will have a~     huge impact on society.~   "
222529|NCT00645983|"~     This study will determine the effectiveness of chamomile extract for treating generalized~     anxiety disorder.~      Study hypotheses: 1)Chamomile extract will have a superior anti-anxiety effect compared to~     placebo. 2)Chamomile will have a comparable safety profile to that of placebo.~   "
222530|NCT00645970|"~     We believe information to be obtained from this proposed study will prove critical for~     planning future VA healthcare strategies and developing effective and efficient treatments~     targeting pain and emotional adjustment difficulties among individuals with polytrauma and~     returning Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) personnel. More~     specifically, this study will be the first to provide systematic data regarding pain and~     emotional problem prevalence, course, associated impairments, risk factors, and barriers to~     care and community reintegration among returning OEF and OIF service members with and without~     polytrauma.~   "
222531|NCT00645957|"~     All patients presenting to Grady Memorial Hospital with an odontogenic (dental) infection~     that requires admission to the hospital and incision and drainage will be eligible for~     inclusion in this pilot study. The surgical method used for incision and drainage will be~     determined by the attending surgeon who will operate on the patient. The surgical procedure~     is a simple and universally standardized involving one or more small incisions in the mouth~     or in the upper neck and the placement of a drain(s) within the infected area to facilitate~     continued drainage of pus. Subjects will be randomized to either a red rubber or penrose~     drain(s). The drains are placed through the mouth or upper neck depending on the location of~     the infection and typically remain in place until the drainage has stopped (several days).~     All drains are secured with a single stitch through the gum or skin. The drain(s) will be~     removed bedside by removing a single suture and gently withdrawing the drain. The timing of~     this is determined by the clinical picture although this typically occurs within the first~     week. This is not a painful procedure. Currently some surgeons place red rubber drains which,~     after placement, allow the infection not only to drain but also be irrigated with saline both~     during the surgery and in the immediate post-operative period. Other surgeons place penrose~     drains, which, after placement, continue to allow the infection to drain but cannot be~     irrigated. Red rubber drains require daily irrigation and as such are labor intensive.~     Furthermore, drains that are irrigated may continue to drain the saline irrigant in the many~     hours after irrigation that upon clinical inspection may be difficult to distinguish from~     sero-sanguinous (pus) drainage. It is daily inspection of the drainage (or lack thereof)~     which determines the appropriate time to remove the drain(s). This in turn may influence time~     to discharge and ultimately hospital costs~   "
222532|NCT00645944|"~     The major goal of this project is to investigate established insomnia treatments in a~     schizophrenia population to see if the improved sleep leads to overall better quality of~     life. In addition, we hypothesize that the insomnia treatment may also lead to observed~     improvements in other symptoms associated with schizophrenia such as cognitive impairments,~     obesity, and negative symptoms.~   "
222533|NCT00645931|"~     This study is designed to examine the psychological effects of bone marrow transplants on~     children and their families. The investigators hypothesis is that families who show signs of~     psychological distress before transplant will continue those signs post transplant. The~     investigators are examining cognitive placement, emotional placement and other psychological~     factors in both the child undergoing transplant and his or her parent.~   "
222534|NCT00645918|"~     The objective of the GRAVITAS trial is to determine whether tailored anti-platelet therapy~     using the Accumetrics VerifyNow P2Y12 assay reduces major adverse cardiovascular events after~     drug-eluting stent implantation.~   "
222535|NCT00645905|"~     Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic~     Plaque Psoriasis~   "
222536|NCT00645892|"~     Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe~     Chronic Plaque Psoriasis~   "
222541|NCT00645827|"~     Insulin infusions are commonly used in hospitalized diabetics to control blood sugar, and~     they are effective. However, insulin infusions require the use of limited resources. Insulin~     infusions are therefore changed to insulin shots as a patient recovers. Once an insulin~     infusion is stopped and shots are started, blood sugar control is harder to maintain. This~     is, in part, because physicians have different ideas on how to dose insulin shots in~     hospitalized patients. A math equation has been developed by the research staff that attempts~     to predict the effective doses of insulin shots in patients whose insulin infusion have just~     been stopped. The math equation was developed for patients with type 2 diabetes mellitus. In~     this study, all patients will be treated with the same type of insulin shots, with doses of~     the insulin shots chosen either by the math equation or by the judgment of the patient's~     physician. The study will then follow blood sugar values for 24 hours to see if the math~     equation is effective. If the equation is proven to be effective, a new tool will exist for~     physicians to determine the best dose of insulin shots for type 2 diabetics. Such a tool~     would, in turn, allow for widespread use of insulin infusions to determine a patient's~     insulin needs before discharge from the hospital. Blood sugar control for type 2 diabetics~     that are inpatient or outpatient would improve as a result, with potentially far reaching~     public health benefits.~   "
222542|NCT00645814|"~     Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic~     Plaque Psoriasis~   "
222543|NCT00645801|"~     The primary objective is to compare the effectiveness and tolerance of Amitiza®~     (lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo and~     GoLYTELY ® (polyethylene glycol-electrolyte solution) as a bowel cleansing preparation for~     colonoscopy.~   "
222544|NCT00645788|"~     To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between~     Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.~   "
222545|NCT00645775|"~     The study investigated the use and efficacy of the seeds of African bush mango (Irvingia~     gabonensis)to control body weight, blood lipids and hormones in overweight and obese people.~   "
222546|NCT00645762|"~     This study is designed to evaluate safety and effectiveness of a less invasive procedure to~     treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally,~     this study will assess the feasibility of performing the procedure under local anesthesia.~   "
222547|NCT00645749|"~     The hypothesis of this study is that helminth-induced immunomodulation therapy (HINT) will be~     safe and effective when administered orally in patients with relapsing-remitting multiple~     sclerosis (RRMS).~   "
222548|NCT00645736|"~     This study has the aim of describing viral mutation profiles in patients diagnosed with~     chronic hepatitis B receiving antihepadnaviral therapy.~   "
222549|NCT00645723|"~     Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus~     inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline~     solution in patients with VAP due to baumannii carbapenems resistant.~   "
222550|NCT00645710|"~     RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Hepatic arterial infusion uses a catheter to carry~     cancer-killing substances directly into the liver. Radiolabeled monoclonal antibodies can~     find tumor cells and carry tumor-killing substances to them without harming normal cells.~     Giving hepatic arterial infusion of floxuridine together with gemcitabine hydrochloride and~     radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain~     after surgery.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of floxuridine when~     given as a hepatic arterial infusion together with gemcitabine hydrochloride and radiolabeled~     monoclonal antibody therapy and to see how well it works in treating liver metastases in~     patients with metastatic colorectal cancer.~   "
222551|NCT00645697|"~     One complication of uveitis which is driven by an increase in VEGF is the formation of~     inflammatory ocular neovascularization (ION). Here, we analyze the therapeutic role of~     intravitreal bevacizumab in ION not responding to standard therapy (systemic and ocular~     corticosteroids and systemic immunosuppressants) in a multicenter retrospective study.The~     natural history of subfoveal choroidal new vessels histoplasmosis, multifocal choroiditis,~     Harada and other inflammatory chorioretinal disorders has been very guarded, but with this~     new approach, we hope to stop the visual loss in these relatively young patients.~   "
222552|NCT00645684|"~     The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal~     surgery as part of a controlled randomized single blinded parallel group trial. The~     applicability and safety of the strand material used in two suture techniques (2-layer suture~     technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the~     operative time consumed for the construction of the 1st anastomosis, the average time of the~     hospital duration for both patient groups, and the frequency of postoperative complications~     after discharge, 1 month and a maximum of 3-4 months. The used suture units are counted and~     the length of sutures determined which will be an indirect measurement of the costs of suture~     material for the two techniques.~   "
222553|NCT00645671|"~     To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment,~     0.5% vs. vehicle for the treatment of inflammation following cataract surgery~   "
222554|NCT00645658|"~     Muscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects~     morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are~     reduced, and likely contributes to the wasting. As TT in relatively safe physiologic~     replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we~     hypothesize that physiologic TT replacement will be effective in preventing and treating the~     loss of muscle mass and function in CKD patients, will improve quality of life and may reduce~     some cardiovascular disease (CVD) risk factors.~   "
222571|NCT00645424|"~     The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the~     treatment of Taiwanese patients with diabetes and high cholesterol.~   "
222592|NCT00645151|"~     The purpose of this study is to determine the percentage of patients who would reach a~     cholesterol goal after atorvastatin treatment.~   "
226709|NCT00590265|"~     The purpose of this study is to evaluate the efficacy and safety of light therapy for the~     treatment of bipolar type II patients relapsing into a depressive phase during autumn or~     winter.~   "
222555|NCT00645645|"~     A study of the complex genetics of brain development will be undertaken with an emphasis on~     those genes that cause the most common structural brain anomaly in humans called~     holoprosencephaly (HPE). This malformation of the brain can result from either environmental~     or genetic causes, and it is the aim of these investigations to determine the genes~     responsible for both normal and abnormal brain development through the study of patients with~     this disorder. Mutations in one such gene, Sonic Hedgehog, have been shown by us to be~     responsible for approximately one quarter of familial cases of HPE. Other genes either~     related to the hedgehog pathway or located at unrelated defined genetic loci may also~     contribute to HPE and are the subject of active investigation. We anticipate that many genes~     important for normal brain development will be identified in the search for genetic causes of~     HPE.~   "
222556|NCT00645632|"~     RATIONALE: Drugs used in chemotherapy, such as ifosfamide, methotrexate, cisplatin, and~     doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving chemotherapy before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it~     after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating~     patients undergoing surgery for newly diagnosed high-grade osteosarcoma.~   "
222557|NCT00645619|"~     The purpose of this study is to determine whether a protein called TREM-1 can be used to~     differentiate viral and bacterial pneumonias in children who are on ventilator support. We~     propose that the level of TREM-1 will be significantly elevated in the lung fluid of children~     with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with~     pure viral pneumonia.~   "
222558|NCT00645606|"~     RATIONALE: Classical chemotherapy does not cure advanced chronic lymphocytic leukemia (CLL)~     despite new drugs. Rituximab is a monoclonal antibody directed against CD20 surface antigen~     on B lymphocytes and leads to apoptosis of CD20 positive B lymphocytes. The highest response~     rate yet published in the treatment of first-line CLL has been obtained by the association of~     fludarabine, cyclophosphamide and rituximab (FCR). Now, the question is whether this response~     can be improved, as some trials showed that eradication of minimal residual disease (MRD) in~     CLL is associated with a longer treatment-free and overall survival. Maintenance therapy~     using rituximab has been recently approved as a means of prolonging remission in patients~     with indolent non Hodgkin's lymphoma. Maintenance therapy with rituximab could be of interest~     in treatment of MRD in CLL and prolonging remission and survival times.~      PURPOSE: The overall purpose of the study is to determine the value of immunotherapy~     maintenance with single agent rituximab in comparison with no further treatment (observation~     ) for previously untreated chronic lymphocytic leukaemia in elderly (>65 years) patients who~     respond to induction immunochemotherapy with FCR.~   "
222559|NCT00645593|"~     This study will compare the effects, good and/or bad, of chemotherapy (Gemcitabine and~     Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which~     treatment is better.~   "
222560|NCT00645580|"~     In our study we aim to examine the effect of SSRI augmentation on negative symptoms and~     cognitive function in schizophrenia patients as well as to examine the effect of SSRI~     augmentation on the RNA and protein products in peripheral mononuclear cells (PMC). Finally,~     we aim to relate changes in PMC elements to changes in clinical symptoms and cognitive~     function. Our study hypotheses are that SSRI augmentation of anti-psychotic treatment in~     schizophrenia patients will improve negative symptoms as well as cognitive symptoms and that~     this improvement will be related to biochemical changes identifiable in PMC elements.~   "
222561|NCT00645567|"~     This is a laboratory-based study to evaluate the risk of shoulder injury associated with~     transfers between wheelchair and vehicle in persons with spinal cord injury. Four new devices~     will be compared against an unassisted transfer.~   "
222562|NCT00645554|"~     The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is~     to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and~     galantamine tablet.~   "
222563|NCT00645541|"~     Primary Objectives:~        -  To determine the feasibility of axillary reverse mapping (ARM) in patients undergoing~          axillary lymph node dissection for breast cancer therapy.~        -  To determine the incidence of breast cancer metastasis in lymph nodes draining in the~          arm as identified by axillary reverse mapping.~        -  To determine the safety of axillary reverse mapping.~   "
222564|NCT00645528|"~     The purpose of this research is to determine if meeting in a group with other subjects with~     diabetes can reduce barriers to starting insulin.~   "
222565|NCT00645515|"~     The purpose of this study is to compare the safety of ziprasidone and risperidone for the~     treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of~     ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to~     compare their tolerability and efficacy.~   "
222566|NCT00645502|"~     The primary objective of this study is to demonstrate the bioequivalence, with respect to~     risperidone and its active moiety, of a single oral dose of risperidone given as a 4 mg~     orally-disintegrating tablet and as a 4 mg conventional RISPERDAL tablet. In addition, their~     tolerability and safety will be documented.~   "
222567|NCT00645489|"~     This is a pilot study of a family-based educational program for patients with heart failure,~     and their family members.~   "
222568|NCT00645463|"~     A recently completed clinical drug interaction study of CP-945,598 with ketoconazole, a~     potent CYP3A inhibitor, showed that coadministration of CP-945,598 with ketoconazole results~     in an approximately 5-fold increase in CP-945,598 total exposure (AUC) and 4-fold increase in~     Cmax. Therefore, the sensitivity of CP-945,598 pharmacokinetics (PK) to less potent CYP3A~     inhibitors needs to be characterized to support labeling and registration.~      Diltiazem is a known substrate and moderate mechanism-based inhibitor of the CYP3A enzyme~     system and was chosen as the moderate CYP3A inhibitor for this study as it is a clinically~     relevant medication likely to be prescribed concomitantly with CP-945,598 given the increased~     risk of hypertension and cardiovascular disease in the obese patient population.~   "
222569|NCT00645450|"~     OBJECTIVE: In the first of two preliminary studies, we demonstrated in individuals with~     chronic PTSD that a single (combined 40 mg short- and 60 mg long-acting) 24-hour oral dose of~     propranolol, compared to placebo, given immediately following reactivation of the~     PTSD-related memory of the traumatic event, significantly reduced physiological responses~     during script-driven imagery of that event measured one week later. These results support~     blockade of reconsolidation of the traumatic memory, a process that is entirely distinct from~     extinction. In addition, we found a trend for post-reactivation propranolol to reduce~     self-reported PTSD symptoms, measured via the Impact of Event Scale-Revised (IES-R). In the~     second preliminary study, we performed 6 weekly treatments that consisted of the subject~     describing their PTSD-related traumatic events for approximately 10 minutes followed by 0.67~     mg/kg (minimum 40 mg) short-acting propranolol plus 1 mg/kg (minimum 60 mg) long-acting~     propranolol. The mean Clinician Administered PTSD Scale (CAPS) Total Score following the six~     treatment sessions was reduced by 44% (p=.02). The proposed work will examine whether~     repeated treatments may succeed in producing more substantive symptomatic improvement.~      RESEARCH PLAN: The study design will be a randomized, double-blind, placebo-controlled,~     clinical trial. A crossover design is not being proposed because the effect is expected to be~     neither short-term nor reversible. Rather, at the conclusion of the formal study period,~     individuals randomized to the placebo condition will be offered an equal number of treatment~     sessions with propranolol. A placebo control will be used, rather than an active treatment~     control, because the proposed study will be a proof of concept test of post-reactivation~     pharmacological reduction of traumatic memories. The control (and active) treatments will be~     structured so as to minimize the chance of extinction. We recognize that eventually this new~     treatment will need to be tested against established PTSD treatments, including exposure, if~     its clinical utility is to be established. We regard this as a matter for subsequent studies~     should the present study yield promising results. However, we do intend to compare the effect~     size we find for the proposed intervention with published effect sizes for other PTSD~     psychotherapies.~      METHODOLOGY: Participants will include male and female combat veterans of the Afghanistan and~     Iraqi wars meeting DSM-IV criteria for chronic PTSD, recruited locally from the Manchester~     VAMC Mental Hygiene Clinic or through advertising. The presence of PTSD will be assessed~     using the CAPS. Participants will be randomly assigned to the propranolol or placebo drug~     condition. During each of six memory reactivation sessions, the participant will meet with a~     psychiatrist, who will ask the participant to spend ten minutes describing the event that~     caused their PTSD, and their reactions to it. The interviewer will facilitate this process by~     asking questions, keeping the participant focused on the traumatic event and encouraging~     him/her to identify aspects of the traumatic event that continue to provoke emotional~     distress. The traumatic memory reactivation will be immediately followed by administration of~     propranolol or placebo. Following the six treatment sessions, script-driven imagery will be~     used to assess HR, SC, and facial EMG responses to recollections of the traumatic event and~     PTSD symptoms will be assessed using the CAPS. A previously developed discriminant function~     will be used to classify each person as a physiologic responder or non-responder. There~     will also be a 6-month follow-up assessment.~      CLINICAL RELEVANCE: The mechanism of memory reconsolidation offers the possibility that~     cellular plasticity can be capitalized on to reverse the neuroanatomical and~     neurophysiological underpinnings of traumatic memories. The possibility that a traumatic~     memory could be significantly weakened by an intervention as simple as the post-reactivation~     administration of a widely used and safe medication has profound implications for the~     treatment of PTSD.~   "
222570|NCT00645437|"~     The primary objective was to evaluate the pharmacokinetics and safety of two dosing regimens~     of levofloxacin in patients with varying degrees of renal function.~   "
222573|NCT00645398|"~     The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo~     for the symptomatic relief of pain associated with fibromyalgia. If this objective is met,~     then the second objective will be to evaluate the efficacy and safety of pregabalin versus~     placebo for the management of fibromyalgia (pain, patient global assessment, and functional~     status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to~     improve sleep, fatigue, and mood disturbance associated with fibromyalgia.~   "
222574|NCT00645385|"~     Subjects with newly diagnosed brain tumors who undergo surgical resection and whose pathology~     in the operating room shows a high grade glioma will be eligible.~      During a screening visit, the study will be discussed, inform consent discussed and signed, a~     medical history will be taken and a physical examination and laboratory tests will be~     performed. If these tests are all within acceptable ranges, the subject will be considered~     for inclusion on this treatment protocol. If the results of any tests are extremely different~     from normal expected values, she/he may not be able to participate.~      Prior to surgery, the subject will have a contrast enhanced MRI and MRS. The neurosurgeon~     will attempt to remove the majority of the tumor in the operating room and will send a~     portion of the specimen removed to the pathologist immediately. This is called a frozen~     section. If the pathologist believes that the tumor is a high-grade malignant brain tumor,~     then the surgeon will place up to 8 dime-sized chemotherapy wafers in the tumor cavity of the~     brain. The remainder of the tumor specimen will be given to the pathologist to review more~     closely in the laboratory. If the frozen section does not show that the tumor is a high-grade~     malignant brain tumor, the subject will not receive the Gliadel wafers and will be removed~     from the study. The surgeon will then discuss with the subject the appropriate treatment~     options for the disease he or she has.~      During recovery in the hospital, another contrast enhanced MRI will be performed within the~     first 72 hours after surgery. This is a standard of care for patients who are not involved on~     this protocol as well. The subject will have another contrast enhanced MRI and MRS performed~     at the 21st Day after his or her surgery. After Day 21, He or she may begin other forms of~     treatment. The last contrast enhanced MRI and MRS assessment will be performed 12 weeks after~     the surgery and the implantation of the Gliadel wafers. Further MRI and MRS may be performed~     subsequently at the discretion of the doctor.~      Throughout the course of treatment, clinical data will be collected.~   "
222575|NCT00645372|"~     The purpose of this study is to compare the efficacy and safety of ziprasidone and~     risperidone for the treatment of schizophrenia in Chinese patients~   "
222576|NCT00645359|"~     This research study is designed to test whether the results of a diffusion MRI scan performed~     after one cycle of chemotherapy for lymphoma can accurately predict the outcome of treatment~     for individual patients.~   "
222577|NCT00645346|"~     The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity~     of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect~     humans from infection.~   "
222578|NCT00645333|"~     New and better therapies for locally advanced and metastatic breast cancer are needed~     because, even if standard treatment is successful in shrinking the cancer, there is still a~     high chance that the cancer will recur. Recent research suggests that breast tumors have a~     small number of cells in them that are breast cancer stem cells, which are very resistant~     to standard treatment. It is thought that the reason that many patients cannot be cured of~     their breast cancers is that the stem cells are unable to be killed and remain in the body~     after standard treatment. Laboratory research has shown that a new drug, MK-0752, can target~     stem cells and prevent tumor recurrences when the drug is combined with docetaxel, a~     chemotherapy drug commonly used to treat breast cancer.~      We know that MK-0752 is safe when given by itself to people. We do not know if treatment with~     MK-0752 and docetaxel combined is safe or if it will kill breast cancer stem cells in~     people with breast cancer. This clinical trial is being done to determine the safety of~     several doses of MK-0752 in combination with docetaxel. Preliminary data about the~     effectiveness of MK-0752 in combination with docetaxel will be collected. Also, tumor biopsy~     samples will be taken from some patients who have tumors that can be easily biopsied. The~     samples will be used to perform research tests to help determine if the breast cancer stem~     cells are being killed by the drug combination.~   "
222579|NCT00645320|"~     The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in~     patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol~     A1281074).~   "
222580|NCT00645307|"~     The purpose of the study was an Open Label Extension to the recurrence prevention study to~     evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia.~   "
222581|NCT00645294|"~     Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents~     infected with chronic hepatitis B.~   "
222582|NCT00645281|"~     The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting~     the primary symptom or complaint of patients with OAB.~   "
222583|NCT00645268|"~     To determine the effect on erectile function in a population of type 2 diabetic men with~     erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a~     daily dose of double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an~     as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (Phase II).~     To assess safety and tolerability of this dosing regimen and to investigate its effects on~     endothelial function and subject's responses to the Self-Esteem And Relationship (SEAR)~     questionnaire.~   "
222584|NCT00645255|"~     The study was designed to evaluate the long term efficacy and safety of Meridia 15 mg daily~     in obese subjects.~   "
222585|NCT00645242|"~     The purpose of this study is to evaluate the safety and efficacy of fluconazole for the~     treatment of tinea capitis in pediatric patients aged 3 to 12 years.~   "
222586|NCT00645229|"~     The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute~     exacerbation of schizophrenia or schizoaffective disorder, including patients with recent~     onset of symptoms~   "
222587|NCT00645216|"~     CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity~     of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare~     the time course of drug concentrations in the body, safety and tolerability of CP-945,598~     given with or without grapefruit juice in healthy obese/overweight subjects.~   "
222588|NCT00645203|"~     To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months~     and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent~     otitis media.~   "
222589|NCT00645190|"~     The purpose of this randomized, double-blind, active-controlled, flexible dosage, multicenter~     study is to evaluate the effectiveness and safety of galantamine tablet (16-24mg/day) for 16~     weeks in the treatment of mild to moderate Alzheimer's Disease (AD) comparing with Donepezil.~   "
222590|NCT00645177|"~     The purpose of this study is to determine the effect of ABT-869 plus paclitaxel compared to~     paclitaxel alone on disease progression in metastatic breast cancer.~   "
222591|NCT00645164|"~     The product is being tested to see if exposure to light causes photoallergic reactions on the~     skin.~   "
222594|NCT00645125|"~     To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin~     oral antibiotic suspension medications in pediatric subjects. It is designed to determine if~     Omnicef or amoxicillin is preferred to the other with regard to taste or smell.~   "
222595|NCT00645112|"~     To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5~     days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a~     total of 5 days, in children between 6 months and 6 years of age, with AOM.~   "
222596|NCT00645099|"~     The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and~     olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids~     (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density~     lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients~     will participate in this study.~   "
222597|NCT00645086|"~     To compare the efficacy of a 5-day course of clarithromycin extended-release tablets (2 x 500~     mg QD) with that of a 7-day course of clarithromycin immediate-release tablets (1 x 500 mg~     BID) in the treatment of acute bacterial exacerbation of chronic bronchitis.~   "
222598|NCT00645073|"~     To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to~     a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial~     sinusitis.~   "
222599|NCT00645060|"~     RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal~     antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming~     normal cells. This may be an effective treatment for advanced cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 DOTA~     anti-CEA monoclonal antibody M5A in treating patients with advanced solid tumors.~   "
222600|NCT00645047|"~     Post-Traumatic Stress Disorder (PTSD) is considered a major public health problem in the U.S.~     due to its high prevalence and high rates of disability associated with the disorder. For~     thousands of veterans, PTSD is a chronic disorder, resulting directly from military service~     that causes substantial psychological suffering and social disability. Barriers to PTSD care~     include poor access, mistrust, and lack of benefit from traditional treatments. This project~     addresses two very important and timely questions. First, can telemedicine be used as a tool~     to extend effective, specialized mental health services such as, cognitive processing therapy~     (CPT), to veterans with poor access to care? Second, does therapy delivered by telemedicine~     effect the quality of care in terms of clinical outcomes (PTSD severity, Quality of Life),~     and the quality of patient-therapist interaction (patient satisfaction & communication)? By~     answering these questions, this study will provide valuable knowledge for VA researchers,~     clinicians, and policy makers. The study findings will have direct implications related to~     making specific recommendations regarding telemedicine utilization to deliver specialized~     mental health services for veterans suffering from PTSD.~   "
222601|NCT00645034|"~     To investigate the effects of a single dose of sildenafil (100 mg) or placebo on blood~     pressure and pulse rate in subjects taking doxazosin for benign prostatic hyperplasia (BPH).~     To investigate the pharmacokinetics of doxazosin when co-administered with sildenafil 100 mg,~     and to investigate the safety and toleration of sildenafil 100 mg when co-administered with~     doxazosin.~   "
222602|NCT00645021|"~     CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect~     its elimination from the body via metabolism. This study will therefore compare the~     pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability~     of CP-945,598 in patients with mild and moderate hepatic impairment and healthy control~     subjects.~   "
222603|NCT00645008|"~     Undergoing cardiopulmonary bypass surgery and the subsequent admission to the intensive care~     unit (ICU) is known to be a stressful event to the patient. As patients prepare for~     open-heart surgery it is natural for them to feel anxious and concerned about all the various~     procedures involved in the process. Members of both the surgical and anesthesia team explain~     the purpose of each procedure and all issues associated with the procedures in great detail~     in order to better prepare the patient, ease their anxiety and aid their recovery.~      The underlying assumption for past investigations into overall patient satisfaction has been~     that the stressors inherent in the experience of illness and hospitalization have an adverse~     effect on patient recovery and can possibly prolong the recuperative process. Previous~     studies have shown that the specific performance of a team in regard to the effects of the~     stressors on the patient's status is key to providing optimal patient care in the ICU~     environment. Since the ICU stay is a difficult experience in the life of a patient, stressor~     predictability might allow for better physical and psychological conditions for the patient's~     recovery.~      Although there is a myriad of published research available on the potential stressors related~     to an ICU stay, there is a dearth of investigation into the inherently more intense~     circumstances surrounding a stay in the Cardiothoracic Intensive Care Unit (CT-ICU). By~     examining the stressors in the CT-ICU changes can be made by the medical care team and/or~     hospital that can ultimately enhance the patient experience in the CT-ICU.~      The purpose of this study is to reduce or completely eliminate stressors present in the~     CT-ICU as identified by the cardiac bypass patient. Identification of events and conditions~     considered stressful in the ICU will allow the professional team to determine which stressors~     are amendable to intervention and tailor patient care accordingly.~   "
222604|NCT00644995|"~     This randomized pilot study will evaluate the feasibility and acceptability of a phone-based~     wellness program for improving mood, physical activity, and smoking abstinence rates among~     people with depression who also are physically inactive and smoke cigarettes.~   "
222605|NCT00644982|"~     To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality~     of life.~   "
222606|NCT00644969|"~     Study will determine whether patients with schizophrenia or schizoaffective disorder can be~     helped to quit smoking safely while using varenicline and receiving smoking cessation~     counseling.~   "
222607|NCT00644956|"~     The objective of this study was to determine and compare the minimum time required to achieve~     penile rigidity greater than or equal to 60% at the base of the penis that is sustained for~     at least 3 minutes measured by Rigiscan®, following visual sexual stimulation post dose of~     100 mg sildenafil citrate and 20 mg tadalafil in men with erectile dysfunction (ED).~   "
222608|NCT00644943|"~     The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7~     mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based~     on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months~     and 6 years of age, with AOM.~   "
222609|NCT00644930|"~     Background and objective: To determine the efficacy of non-invasive positive pressure~     ventilation (NPPV) and its effects upon intubation rate and mortality in ARDS.~   "
222610|NCT00644917|"~     The product is being tested to see if exposure to light causes toxic reactions on the skin.~   "
222611|NCT00644904|"~     Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at~     risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.~      This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of~     40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS~     characteristics will be divided into two groups: one group receiving the high dose Vitamin D~     regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that~     patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events~     and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher~     doses will demonstrate improved relapse and disability status compared to controls, and that~     the treatment group will show improved markers of bone health and immune indicators of~     reduced inflammation.~   "
222612|NCT00644891|"~     To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin~     oral antibiotic suspension medications in pediatric subjects. It was designed to determine if~     Omnicef or amoxicillin is preferred to the other with regard to taste or smell.~   "
222613|NCT00644878|"~     This exploratory study will evaluate the change in molecular response in chronic myelogenous~     leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal~     molecular response to imatinib~   "
222614|NCT00644852|"~     The purpose of the study is to evaluate the characteristics, clinical responses, and safety~     issues of patients receiving long-term treatment of Risperidone long-acting injectable. The~     goal is to evaluate patient outcomes based on pre-existing risk or disease factors and past~     medication use.~   "
222615|NCT00644839|"~     Experiment in the test tube indicated that CP-945,598 becomes less soluble with increase of~     pH (less acidity). Changes in stomach acid levels may affect the solubility of CP-945,598,~     therefore, alters its availability in the blood. Omeprazole decreases acid levels in stomach.~     This study will compare the time course of drug concentrations in the body, safety, and~     tolerability of CP-945,598 given with and without omeprazole.~   "
222616|NCT00644826|"~     The purpose of this study is to determine whether preventive home visits for people aged 80~     and over are effective in the prevention of nursing home admission in Germany.~   "
222617|NCT00644813|"~     A significant subset of patients with scapula fractures also involves the glenoid neck (bone~     joining the shoulder joint the scapular body). There is little evidence pertaining to the~     best treatment or precise definition of these lesions. This study will be designed as a~     prospective, non-randomized cohort study that will collect outcome and radiological data on~     patients who have sustained a fracture of the glenoid neck (bone joining the shoulder joint~     the scapular body) for a period of 1 year. All patients who have sustained extraarticular~     scapula fractures (any fracture not involving the glenoid surface) will be considered.~     Information will be collected with respect to the radiographic characteristics of osseous~     injuries as well as functional outcome over time.~   "
222618|NCT00644800|"~     To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the~     treatment of the acute exacerbation of non-organic psychosis of any etiology, including~     schizophrenia, acute mania, delusional disorder and others.~   "
222619|NCT00644787|"~     The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day~     application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so~     the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl~     1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch~     in participants with cancer pain.~   "
222620|NCT00644774|"~     To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and~     azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.~   "
222621|NCT00644761|"~     Open-label pharmacokinetic drug interaction study.~   "
222622|NCT00644748|"~     The purpose of this study was to evaluate the efficacy, safety, and tolerability of~     gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of~     life of all treated patients was also assessed.~   "
222623|NCT00644735|"~     A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when~     treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that~     is in remission (i.e. previously healed EE).~   "
222624|NCT00644722|"~     New single use laryngoscope metal blades are available for intubation. This type of blade is~     safer than the reusable ones concerning the interhuman cross infection risk. No clinical~     studies have compared the two types of blades in the emergency context. The primary aim of~     this study is to demonstrate that single use blades are as efficient as the reusable ones~     concerning intubation conditions.~   "
222625|NCT00644709|"~     A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high~     cardiovascular risk at the LDL cholesterol goal of <115 mg/dL~   "
222626|NCT00644696|"~     This Phase One pediatric trial seeks to take advantage of the susceptibility of neuroblastoma~     to proteasome inhibitors, proven in vitro, along with the proven in vitro synergy of~     bortezomib with irinotecan and the successful Phase One pediatric trials of bortezomib to~     create a treatment using these two drugs in combination to treat refractory/recurrent~     neuroblastoma in children and young adults 25 and under.~   "
222638|NCT00644540|"~     The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza~     Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To~     evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in~     healthy children aged up to 35 months; to evaluate the safety and tolerability of a single~     0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.~   "
222660|NCT00644254|"~     Extracapsular lymph node involvement (ECLNI) has been identified as a pathological variable~     associated with worse outcome in esophageal, gastric and colorectal cancer. No studies so far~     have studied its prognostic impact in ductal pancreatic adenocarcinoma (DPAC). The goal of~     the investigators is to determine the prognostic value of ECLNI in a prospective consecutive~     series of 145 patients with DPAC, who underwent resection of their primary tumor between 1998~     and 2005.~   "
222661|NCT00644241|"~     India is the Diabetes Capital of the World with 41 million Indians having diabetes i.e.~     every fifth diabetic in the world is an Indian1. Type 2 Diabetes Mellitus (T2DM) constitutes~     the major chunk of diabetes and has insulin resistance as the hallmark feature in the~     pathogenesis. However, with the progression of the disease the insulin resistance becomes~     stable whereas β - cell function shows a gradual decline due to its ongoing apoptosis2. This~     ultimately leads to inability of the β - cells to cope up with the increased demand of~     insulin caused due to insulin resistance and manifests as hyperglycemia. As β - cell failure~     is progressive and inexorable, as demonstrated in United Kingdom Prospective Diabetes Study3,~     most of the patients with T2DM would eventually require insulin and it would be difficult to~     achieve to attain a strict glycemic control . It is well known that diabetes related~     complications which account for morbidity and mortality in this disease can be prevented or~     delayed by strict glycemic control. However, even with intensive insulin therapy it has been~     shown that glycemic control can never be perfect with patients exhibiting hyperglycemia or~     hypoglycemia during 24 hour glucose profile4. Also insulin therapy is not physiological as~     there is no hepatic first - pass metabolism of insulin which is required for halting the~     hepatic glucose output, which is responsible for fasting hyperglycemia5. This led the~     researchers to evolve various strategies of β - cell replacement therapy e.g. pancreatic~     transplantation and islet cell transplantation. Initially the results of islet cell~     transplantation were dismal but after the induction of glucocorticoid free immunosuppressive~     therapy and the use of adequate number of islet cells from multiple donors, the results of~     islet cell transplantation have been better6. However, islet cell transplantation has its own~     limitations viz insufficient supply, being technically demanding and requirement of lifelong~     immunosuppressive therapy in the recipient.~      These shortcomings can be overcome by the use of stem cells which is an inexhaustible source~     of β -cells. Stem cells are primitive cells capable of differentiating into mature cells of~     the body of various lineages. Stem cells can be obtained from various sources like blastocyst~     (embryonal stem cells), umbilical cord or bone marrow. There is an evidence to suggest that~     stem cell transplantation can lead to improvement in pancreatic endocrine function and~     improvement in glycemic control in diabetic mice7,8,9,10 through various mechanisms such as~     transdifferentiation or regeneration of endothelial cell in the damaged islets which in turn~     lead to regeneration of islet cells by paracrine action11. However, till date there is no~     study that demonstrates that stem cell therapy can be effective in patients with T2DM for~     their glycemic control.~      The investigators propose to carry out autologous bone marrow - derived stem cell~     transplantation (ABMSCT) in patients of T2DM, obtained from their own bone marrow and its~     superselective injection into the gastroduodenal artery after purification without any~     immunosuppressive regimen.~      Aim:~      The aim of this study is to reverse hyperglycemia and insulin dependency by ABMSCT in~     patients with type 2 diabetes mellitus.~      Hypothesis:~      The investigators hypothesize that ABMSCT into the pancreas of patients with T2DM, aged more~     than 30 years with insulin requirement of 0.7 U/ kg body weight/day or 50 U / day whichever~     is lesser, will lead to abolition or reduction of insulin requirement by more than or equal~     to 50% in these patients over a period of 6 months. It is assumed that ABMSCT will lead these~     patients to regenerate functional β - cells by transdifferentiation or by regeneration of~     endothelial cell which in turn cause β - cells neogenesis by paracrine effect.~      Objectives:~      Primary objective:~        1. Abolition or reduction of insulin requirement by > 50% by the end of 6 months of ABMSCT.~        2. To evaluate the increment of Glucagon stimulated C - peptide response at the end of 6~          months of ABMSCT, as compared to the baseline values.~      Secondary objective:~        1. Any reduction in requirement of insulin dosage.~        2. Improvement of HbA1c levels as compared to baseline.~   "
223668|NCT00630968|"~     The purposes of the study were to obtain further information about the optimal dose and the~     efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and~     tolerability profiles of the drug observed during clinical development.~   "
222627|NCT00644683|"~     Premenopausal women who are diagnosed with breast cancer are frequently treated with~     chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary~     loss of menstrual periods to permanent menopause. It is difficult to predict how an~     individual's ovarian function will be affected by chemotherapy. There are a number of~     hormones which can be measured in the blood which are related to fertility and ovarian~     function. The levels of these hormones may change with chemotherapy, and may relate to the~     effect of chemotherapy on the ovaries.~      In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed with~     breast cancer and will be treated with chemotherapy. We will check blood levels of the~     hormones before, immediately after, and 1 year after treatment with chemotherapy. We will~     only be checking these blood tests for this study; the type of chemotherapy given will be up~     to the patient and her oncologist. We will also ask some questions about factors that can~     influence the levels of these hormones, such as number of children, age of menopause of other~     family members, and smoking history. The results from this study will be used to help us~     develop future studies looking at changes in ovarian function with chemotherapy, and the~     effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.~   "
222628|NCT00644670|"~     The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering~     cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across~     starting doses of 10 mg, 20 mg, or 40 mg with one step titration.~   "
222629|NCT00644657|"~     This study will explore the effect of clopidogrel on coated-platelets in patients who are~     given a loading dose before diagnostic catheterization or percutaneous coronary intervention.~     We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and~     therefore more hypercoagulable.~   "
222630|NCT00644644|"~     -  Reduction in time to detection of Clinically Significant events~        -  Reduction of time to Intervention during Clinically Significant events~        -  Reduction in the number of admissions to Intensive Care~   "
222631|NCT00644631|"~     To compare the effects of sildenafil versus placebo on the female partner's sexual~     satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject~     Questionnaire (FePEDS-Q): Over the past 4 weeks, when you had sexual intercourse, how often~     was it satisfactory for you? For ED subjects, determine difference in the Erectile Function~     domain of International Index of Erectile Function (IIEF) between sildenafil citrate and~     placebo at end of the treatment phase and determine the overall relationship between improved~     erectile function and increased ED subject and female partner satisfaction.~   "
222632|NCT00644618|"~     For patients with unresectable locally advanced pancreatic cancer, the combined use of~     external-beam radiation therapy (EBRT) and systemic chemotherapy of 5-FU has been widely~     recognized as the most effective chemoradiotherapy approach.But most patients succumb to~     local recurrence and metastasis after treatment, and the prognosis remains poor On the basis~     of the development and superiority of the interstitial brachytherapy and the radiosensitizing~     effect of gemcitabine, we performed a clinical study to explore the interaction of improved~     I-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine~     treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.~   "
222633|NCT00644605|"~     To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day~     [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and~     tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension~     who are aged 18 years and over. To investigate the plasma concentration-effect relationship~     and to determine the population pharmacokinetic (PK) parameters.~   "
222634|NCT00644592|"~     This is a research study of how a cholesterol medication known as fenofibrate works~     differently in people with different genetic backgrounds. Genetics refers to certain things~     that are passed to a person by their parents, such as eye color or hair color. Genetic~     differences lead to people having different eye and hair color. There are also genetic~     differences in a protein called liver X receptor-alpha (LXRA), which may be important in~     predicting the response to fenofibrate.~   "
222635|NCT00644579|"~     As many as 85 % of renal transplant patients may suffer from viral warts with a high degree~     of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid)~     point to a beneficial effect without noticeable side effects of bLAC (bovine lactalbumin~     complex with lipid). The aim of first clinical trial with bLAC is to show proof of concept in~     treatment of cutaneous wart lesions on hands and/or feet after local administration of bLAC~     in two dose groups to immune suppressed, kidney transplanted patients.~   "
222636|NCT00644566|"~     Due to the shortage of child psychiatrists and the high prevalence of child mental health~     disorder, pediatricians and other pediatric primary care providers often assume~     responsibility for the management of various psychiatric disorders, including ADHD, Attention~     Deficit Hyperactivity Disorder. However, pediatricians have not been well-trained during~     residency to deal with the complexities of ADHD management. In addition, the system of care~     under which pediatricians practice do not afford the time availability that is required to~     properly manage a child with ADHD. On the other hand, if a pediatrician wishes to refer a~     patient to a child mental health specialist, many obstacles, including but not limited to~     stigma, insurance issues, and long waiting lists, often interfere with the patient actually~     receiving services for his/her ADHD. This research project seeks to examine an innovative~     model of care in which a child psychologist is located on the premises of a pediatric office~     and is available to share the care of patients with the pediatrician in order to address~     ADHD. We hypothesize that parents as well as pediatricians will be more satisfied with this~     model of care and that patients will ultimately have better outcomes. The beginning of our~     pilot has shown under-identification to be a barrier to care as well, and thus we propose to~     implement a quality improvement initiative to screen children for psychosocial issues as~     well. As we have had trouble with recruitment and unfortunately have had more children~     randomized to TAU than shared care, we propose in December 2007 a phase 2 of our study where~     all subjects, instead of randomization, are entered into shared care.~   "
222637|NCT00644553|"~     To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin~     extended-release tablets (2 x 500 mg QD) with that of a 14-day course of~     amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects~     with Acute Bacterial Sinusitis (ABS).~   "
222639|NCT00644527|"~     Depressive symptoms are highly prevalent in the population. According to data from a Zurich~     longitudinal study, the lifetime incidence rate for severe depressive symptoms is 95%. Not~     all persons with depressive symptoms, however, need psychotherapeutic, psychiatric or~     pharmaceutical treatment. Many people specifically or unspecifically use music to influence~     their mood and clinical evidence demonstrates that active involvement in music supports an~     individual's treatment success during psychiatric therapy. The gray area of depressive~     symptoms that do not require medical treatment, but which contribute to a considerable~     disturbance of an individual's quality of life and ability to work, is the focus of the~     proposed study.~      The study investigates whether listening to specific music programs arranged to influence~     depressive symptoms for 30 minutes in the morning and 30 minutes in the evenings can result~     in improvement of an individual's symptoms, as compared to listening to no prescribed music~     or no music treatment at all. Of specific interest is the use of music in the evening, which~     may contribute to the achievement of restive sleep.~      The study's objective is to determine if the utilization of two specific music therapies to~     treat depressive symptoms, compared to a waiting list control intervention and an~     intervention listening to Mozart over a 5 week period, leads to an improvement of the~     depressive pathology among patients with moderate depressive disorders or patients with~     dysthymia. The study is designed as a simple blinded placebo-controlled study.~   "
222640|NCT00644514|"~     The purpose of this study is to identify the mediators and genes in airway epithelial and BAL~     cells that are differentially regulated following inhalation of endotoxin lipopolysaccharide~     (LPS) among study participants with allergic asthma and normal phenotypes. This approach is~     designed to identify novel genes associated with both asthma pathogenesis and asthma~     susceptibility. LPS, or endotoxin, a cell wall component of gram-negative bacteria, is~     ubiquitous in the environment, and is thought to influence both susceptibility and severity~     of asthma.~      240 subjects (healthy adult men and women (age >18-40) with and without atopy and asthma)~     will complete the screening evaluations in order to establish 3 study groups of 60 subjects~     each. Each qualified subject will undergo an inhaled LPS endotoxin challenge followed by~     bronchoscopy after 24 hours, which will consist of a bronchoalveolar lavage (BAL) and~     endobronchial brush biopsies. BAL involves squirting a small amount of sterile salt water~     into one of the airways then gently taking it back out through the bronchoscope. The brush~     sample involves gently moving a small brush back and forth in an airway to collect cell~     samples. Samples of whole blood will also be obtained at various time points. RNA will be~     isolated from these cell populations in order to assess differential gene expression~     expression using microarrays.~   "
222641|NCT00644501|"~     The study is an open-label extension study, offering patients who participated and completed~     previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2~     additional years. The expectation is first to demonstrate that extended treatment with~     DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only~     patients who completed the previous 2-year study and still have beta-cell function above a~     threshold level will be eligible for this extension study.~   "
222642|NCT00644488|"~     The purpose of this clinical study is to assess the safety and tolerability of BMS-641988~     once daily orally in Japanese patients with castration resistant prostate cancer~   "
222643|NCT00644475|"~     BACKGROUND The effects of ACE-inhibitors on fibrinolysis are well documented. Experimental~     and clinical studies have shown that ACE inhibitors induce a reduction in plasma PAI-1 levels~     in many cardiovascular diseases, like hypertension, coronary heart disease, and heart~     failure. Their effects on t-PA are more controversial, due to the fact that t-PA exists in~     several forms, including free and bound to PAI-1. Indeed an increase in t-PA activity has~     been observed in humans and it seems related to bradykinin increase which is known to~     stimulate endothelial t-PA synthesis. These favourable effects on fibrinolysis could be~     related not only to the Angiotensin II reduction and the bradykinin increase but also to the~     improvement in insulin sensitivity, as insulin has been suggested as one of the main~     regulators of fibrinolytic activity.~      To date conflicting results have been reported about the effects of ARBs on fibrinolysis.~     Some studies have reported small improvements, others no significant effect. These~     conflicting results may be due to possible methodological bias but a possible~     pathophysiological explanation might be that receptor subtypes other than AT1 mediate the~     effect of Angiotensin-II on endothelial PAI-1 expression, i.e. the AT4 receptors, and during~     AT1 receptor blockade there is an important increase not only of Angiotensin-II, but also of~     all its catabolites including Angiotensin IV. The dissimilar effects on of ACE Is and ARBs~     may also depend on their different action on the RAS and their different effect on insulin~     sensitivity: ACE-Is improve insulin sensitivity, while the majority of ARBs have been~     reported to have a neutral effect. Moreover, unlike ACE-Is, ARBs do not affect the metabolism~     of bradykinin, which is known to stimulate t-PA synthesis and release.~      AIM OF THE STUDY The aim of this study is to verify the effect of imidapril compared to~     candesartan on insulin sensitivity, evaluated through the euglycemic hyperinsulinemic clamp,~     and on fibrinolysis, evaluated through the plasma PAI-1 and t-PA activity, in mild to~     moderate hypertensive patients.~   "
222644|NCT00644462|"~     The PulmoTrack® 2010 with WIM-PC™ Technologies device, indicated for acoustic pulmonary~     function measurement that quantifies the presence of wheezing. This study was designed in~     order to evaluate the efficacy and safety of using the WIM-PC™ device for wheeze detection~     during dynamic bronchial situations in asthmatic adult.~   "
222645|NCT00644449|"~     This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least~     as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of~     chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of~     both treatment regimens~   "
222646|NCT00644436|"~     To determine if Tetrix Cream remains on the hands after gentle washing with soap and water~   "
222647|NCT00644423|"~     An increasing literature shows that omega-3 fatty acids provide numerous health benefits,~     including a variety of psychiatric symptoms and disorders including stress, anxiety,~     cognitive impairment, mood disorders (major depression and bipolar disorder) and~     schizophrenia. Omega-3 fatty acids may additionally represent a promising treatment strategy~     in patients with PTSD. Moreover, given its beneficial cardiovascular effects, adjunctive~     omega-3 fatty acids may also benefit the general health status of these veterans, who~     frequently present with a variety of comorbid medical disorders.~   "
222648|NCT00644410|"~     It is a single centre, randomised controlled study of the effect of NOGA-guided direct~     intramyocardial injection of mesenchymal stromal cells on the development of new myocardium~     and blood vessels in patients with heart failure.~      Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before~     injected into the myocardium.~      The patients will be followed with safety, clinical, MRI and CT endpoints for 1 year.~   "
222683|NCT00643955|"~     Evaluation of muscle strength and central activation of muscle in individuals with Down~     Syndrome~   "
222684|NCT00643942|"~     The clinical objective of this study is to quantify the levels of corneal and conjunctival~     staining in a healthy, non-dry eye population. This is a descriptive study without test~     article administered.~   "
222649|NCT00644397|"~     Internal fixation of femur fractures improves alignment and provides stability to the bone~     and the surrounding soft tissues. This generally allows for early motion of the adjacent~     joints; thus maximizing overall function of the limb. Open reduction and internal fixation~     with plates and screws is the standard method that has been used in the treatment of distal~     femoral fractures. One common traditional method of internal fixation is the 95-degree angled~     blade plate. Recent advances in technology for distal femur fractures include the LCP™~     Condylar Plate. This implant differs from the blade plate, because the LCP offers multiple~     points of fixed angle contact between the plate and screws in the distal femur. The~     introduction of plates with the option of locked screws has provided means to increase the~     rigidity of fixation in osteoporotic bone or in periarticular fractures with a small distal~     segment, and the LCP may be technically easier to apply than the blade plate. To the~     investigators' knowledge, there have been no published clinical or biomechanical studies~     specific to the LCP Condylar Plate, although the early results of LCP implants for other~     fractures are promising. The investigators believe that locked plating represents a valuable~     advancement in fracture treatment. However, the limitations of this new technology and the~     indications for its use have not been completely elucidated. Furthermore, the cost of the new~     technology is approximately seven times more than the traditional treatment. This is a~     randomized, prospective, multi-center study to compare the blade plate and the LCP in the~     distal femur. All patients 16 years of age or older, regardless of race or gender, with a~     supracondylar fracture of distal femur will be considered. Whether patients are treated with~     a blade plate or/and LCP, they will be receiving standard orthopedic care for their injury.~     Neither of these methods currently places a patient at increased surgical or post-surgical~     risk for problems with infection, nonunion, malunion, or other complications. Because of the~     study, early and late complication rates and functional outcomes after these treatments may~     be better defined, allowing for optimization of care of people with these injuries in the~     future. This should reduce not only direct and indirect costs to the individual, but also~     costs to society.~   "
222650|NCT00644384|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of acitretin may stop cancer from growing in patients at high risk for basal cell carcinoma~     or squamous cell carcinoma of the skin.~      PURPOSE: This randomized trial is studying how well acitretin works in preventing skin cancer~     in patients at high risk for skin cancer.~   "
222651|NCT00644371|"~     To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative~     conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic~     transplantation of haematopoietic stem cells from family donor's peripheral blood.~   "
222652|NCT00644358|"~     This open label 52-week clinical trial is designed to assess the safety and tolerability of~     vilazodone and to analyze genetic markers of response to vilazodone in adult patients~     diagnosed with MDD. This study will enroll approximately 600 patients.~   "
222653|NCT00644345|"~     Microvolt T-Wave Alternans (MTWA) is a relatively new non-invasive method for identifying~     patients at increased risk of sudden death from ventricular arrhythmias. MTWA can be measured~     during a routine exercise test, during pharmacologic stress or during cardiac pacing. Its~     clinical performance compares favorably with that of other non-invasive risk stratifiers and~     invasive electophysiologic studies. The purpose of the present study is to define the~     reproducibility of MTWA testing.~   "
222654|NCT00644332|"~     According to the American Heart Association (AHA) 2011 update of heart disease and stroke~     statistics, more than 9 million adult patients in the United States (US) have angina. This~     update also notes that a study of 4 national cross-sectional health examination studies found~     that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher~     among women than men. Per ACC/AHA guidelines, the goal of antianginal therapy is the complete~     or near complete elimination of anginal chest pain and a return to normal activities and~     functional capacity. However, evaluating angina and responses to antianginal therapy is often~     not straightforward. This is particularly true of female patients with angina. Because angina~     and response to antianginal therapy may differ in men and women, an instrument designed~     specifically to address symptomatology in women with angina could enhance our understanding~     and characterization of angina and responses to therapy in this population. The current study~     will evaluate the validity, reliability, and responsiveness of the newly developed Women's~     Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female~     angina population treated with ranolazine, compared with the widely used Seattle Angina~     Questionnaire (SAQ).~   "
222655|NCT00644319|"~     RATIONALE: Morphine and ibuprofen help lessen pain caused by pleurodesis. It is not yet known~     whether one drug is more effective than the other in lessening pleurodesis-related pain or~     whether the size of the chest drain tube affects pain.~      PURPOSE: This randomized clinical trial is studying ibuprofen to see how well it works~     compared with morphine in treating pain in patients undergoing pleurodesis for malignant~     pleural effusion.~   "
222656|NCT00644306|"~     In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been~     usedsince the 1960s and is regarded as the standard of care in very elderly patients. We~     assess whether the addition of thalidomide at 100 mg/day to this combination would improve~     survival.~   "
222657|NCT00644293|"~     To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day~     course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and~     adults with strep throat, and to assess efficacy and safety for both treatment regimens.~   "
222658|NCT00644280|"~     To determine whether ranibizumab therapy before and after tube insertion for glaucoma~     surgeries can maintain the patency of the tube and prevent scar formation, and increase the~     chances for a successful procedure compared to observation.~   "
222659|NCT00644267|"~     We have established a Telemedicine System for chronic disease management. Based on a personal~     health record, we have successfully used this system in diverse populations, in over 600~     patients, and in multiple disease states (heart failure, CVD risk reduction, gestational~     diabetes). In this proposal, we will enhance this Telemedicine system to support patient~     centered care (PCC) by increasing access, incorporating hypertension treatment guideline,~     quality measures, automating reminders and feedback for both patients and health care~     providers.~      Inner-city, primarily African-American patients (N=252) with uncontrolled hypertension~     (BP<140/90 mmHg) and who are followed by primary care physicians will be randomized to either~     a usual care or a telemedicine group (Telemedicine plus usual care). Blood pressure, weight,~     BMI, blood glucose and lipids, and physical activity will be measured at baseline and at 6~     months. We hypothesize that more subjects in the telemedicine group will achieve goal blood~     pressure than in the control group. This will occur through increases in knowledge,~     self-management, shared decision-making, and improved doctor-patient interaction. Primary~     end- point will be the proportion of subjects who achieve goal blood pressure. Secondary~     end-points will include:~      Rate of self-monitoring, steps per day, weight, CVD knowledge, number of patients at~     medication guidelines, and increased satisfaction with practice. Telemedicine utilization~     will also be determined. We believe that telemedicine can facilitate PCC and reduce blood~     pressure in a cost effective manner.~   "
222662|NCT00644228|"~     This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see~     how well it works compared to dexamethasone and lenalidomide alone in treating patients with~     previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may~     stimulate the immune system in different ways and stop cancer cells from growing. Drugs used~     in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether~     lenalidomide and dexamethasone is more effective with or without bortezomib in treating~     multiple myeloma.~   "
222663|NCT00644215|"~     purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and~     MMC drop in management of early bleb failure .~      Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after~     filtering or combined surgery with MMC which don't respond to high frequent topical steroids~     and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin~     drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and~     first and third month will be obtained.Patients will follow for at least 3 months and IOP~     ,bleb configuration will check as primary outcome measures.Preoperative and postoperative~     data,complications,and the need for further surgical procedures will be evaluated.~   "
222664|NCT00644202|"~     The purpose of this study is to examine how adults can improve their physical activity levels~     and eating habits using an interactive web-based weight control program and regular contact~     with a dietician.~   "
222665|NCT00644189|"~     Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and~     works in two different ways. It affects the development of new cancer cells by blocking two~     enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call~     can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing~     cancer cells to die by disturbing components within the cancer cell. This causes the release~     of a substance that is fatal to the cell.~      This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin~     lymphomas.~   "
222666|NCT00644176|"~     The objective of this trial was to characterize the pharmacokinetics of the currently~     marketed azithromycin immediate release tablet formulation (AZ-IR) versus the azithromycin~     sustained release liquid formulation (AZ-SR) in lung tissue and bronchial washings, the~     latter consisting of the epithelial lining fluid (ELF) and cellular elements, mainly alveolar~     macrophages (AM).~   "
222667|NCT00644163|"~     This study will evaluate the effectiveness of a risk-reduction program in preventing the~     transmission of HIV and sexually transmitted diseases among African-American heterosexual~     couples, with one partner having been previously diagnosed with an HIV infection.~   "
222668|NCT00644150|"~     This study will evaluate the effectiveness of a physician training program, the Ai Shi Zi~     program, in improving HIV/sexually transmitted infection diagnosis, treatment, and management~     by Chinese physicians and in reducing the number of subsequent infections in their patients.~   "
222669|NCT00644137|"~     The goal of this study is to examine the effects of a GABA (gamma amino butyric~     acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal~     and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day,~     will be more effective than placebo in decreasing smoking behavior and attenuating tobacco~     withdrawal and cigarette craving.~   "
222670|NCT00644124|"~     The purpose of this study is to determine the selected dose of aflibercept when it is~     combined with R-CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone~     +/- intrathecal Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin~     B-cell lymphoma, and to determine how the body handles aflibercept when it is administered~     with R-CHOP.~   "
222671|NCT00644111|"~     Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to~     reduce post-operative pain, opioid consumption and related side effects, and length of~     hospital stay. Current research demonstrates a modest improvement in these areas beginning on~     the third post-operative day. MIS fusion, however, incurs significant cost as the average~     time of the procedure is approximately one third greater (from 148 minutes to 191 on~     average). Epidural analgesia has clearly demonstrated benefits for conventional open~     laminectomy. In order to fully maximize the benefits of an MIS technique, early~     post-operative analgesia/pain must be improved. The aim of this study is to combine two~     techniques to ultimately improve patient outcomes and satisfaction. This will be a randomized~     trial involving 32 patients undergoing MIS decompression and fusion with half the study group~     receiving active epidural and IV-PCA and the other half receiving epidural placebo and~     IV-PCA.~      The hypothesis is that epidural analgesia will reduce post-operative opioid consumption,~     improve pain scores, and decrease time to ambulation as well as discharge from hospital after~     MIS decompression and fusion.~   "
222672|NCT00644098|"~     The purpose of this study is to investigate whether the addition of capsules containing~     soluble fibre complex emulsified with medium chain triglycerides and taken before with meals~     will lead to a significant amount of weight loss, reduced glycemic volatility and diminished~     cardio metabolic risk factors in overweight and obese individuals when compared to a placebo~     control.~      We believe that those participants taking 3-6 capsules per day of the treatment capsules over~     a 14 week period will loose a significant amount of weight compared to the placebo group.~   "
222673|NCT00644085|"~     To investigate the effect of daily administration of low-dose aspirin, compared to placebo,~     on IVF and ICSI outcome.~   "
222685|NCT00643929|"~     A long term observational ocular safety study in adults who have received study medication~     (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag.~     The study will follow subjects for 2.5 years following their last ocular assessment on their~     prior treatment study (regardless of the therapeutic indication) and will describe long-term~     ocular safety with respect to changes in the lenses over time from all subjects.~   "
222813|NCT00642265|"~     Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two~     groups: conservative or operative treatment. The conservative arm is treated with a sling for~     6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.~      Patients are clinically and radiologically evaluated during 1 year. A economical analysis is~     also done.~   "
222674|NCT00644072|"~     Background:~      SNX-5422 is an experimental drug that inhibits a protein called Hsp90, which is important for~     the growth of tumor cells.~      SNX-5422 has shown some activity against tumors in the laboratory and animal studies.~      Objectives:~      To determine the highest safe dose, or maximum tolerated dose (MTD), of SNX-5422 that can~     safely be given to patients with solid tumor cancers and lymphomas when taken twice a week.~      To learn how the body's blood and tissue cells react to SNX-5422.~      To examine the effects of SNX-5422 on tumors and lymphomas.~      Eligibility:~      Patients 18 years of age or older who have solid tumor cancers or lymphomas that do not~     respond to standard therapy or for whom no acceptable standard treatment is available.~      Design:~      SNX-5422 is taken by mouth twice a week in 28-day cycles. Treatment may continue as long as~     the cancer does not worsen and side effects are acceptable. Three to six patients are~     enrolled in the study at a time. Each group is given a higher dose of SNX-5422 than the~     previous, as long as the preceding dose was tolerated and until the MTD is determined. When~     the MTD is found, six more patients are enrolled at that dose level.~      During the treatment period, patients undergo the following tests and procedures:~        -  Clinic visits for a physical examination each treatment cycle to check on health status.~        -  Blood tests for routine laboratory values, to determine how the body handles SNX-5422,~          and to examine the effects of SNX-5422 on blood cells and other targets.~        -  Urine tests as needed, depending on the results of blood tests.~        -  CT scans, or other imaging tests every 8 weeks to evaluate the tumor response to~          treatment.~        -  Tumor biopsy (surgical removal of a tissue sample for examination under a microscope)~          before the first dose of SNX-5422 and again 24 hours after the first dose to see how the~          drug affects the tumor. This test is optional.~   "
222675|NCT00644059|"~     This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5~     mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza~     and non-adjuvanted influenza control vaccines in subjects 6 to <72 months of age.~   "
222676|NCT00644046|"~     The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in~     Taiwan (1, 2). More than 45,000 patients are under renal replacement therapy in the year 2004~     (2). The disease had not only caused a significant impact in personal life, but also a great~     burden on social security and government-run health insurance. However, despite this high~     prevalence, the awareness of chronic kidney disease (CKD) in general population remains low~     (3, 4). The patients always come out too late for the intervention to slow down the~     progression of renal failure. Furthermore, most of them are not well prepared for the renal~     replacement therapy. The facts result in high mortality and morbidity in this specific~     population (5). It is mandatory to screen out and treat these patients early enough. However,~     these patients are deep into the community as the asymptomatic nature of CKD.~      The major purpose of the study is to screen the community for the early CKD and provide the~     appropriate intervention at time. The study will collect the characteristic demographic~     epidemiological data and find out risk factors for CKD of this geographic area, provide~     multidisciplinary education of CKD and establish timely referral for appropriate nephrologist~     care for treatment and monitoring of complications.~   "
222677|NCT00644033|"~     The primary objective of this study was to determine whether frovatriptan was effective in~     the prevention of menstrually associated migraine (MAM) headaches when compared to placebo.~     Secondary objectives included determining the effectiveness of frovatriptan in reducing the~     incidence, severity and duration of MAM headaches and associated symptoms, to evaluate the~     safety and tolerability of the two frovatriptan dosing regimens and to compare the~     effectiveness of these regimens in the prevention of MAM headaches. In this cross-over study,~     patients treated each of 3 perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg~     daily (QD) and 2.5 mg twice daily (BID) for 6 days, starting 2 days before the anticipated~     onset of a MAM headache.~      A statistically significant reduction in the incidence of MAM headache (p<0.0001) was~     observed with both dosing regimens of frovatriptan when compared to placebo. Additionally,~     the frovatriptan BID regimen was superior to the frovatriptan QD regimen in the prevention of~     MAM headache (p<0.001). Significant reductions in MAM headache severity and duration, the~     incidence of associated symptoms and characteristics, and the use of rescue medication were~     observed when the PMP was treated with frovatriptan, compared to placebo. Both dose regimens~     of frovatriptan were equally well tolerated and no cardiovascular or other safety and~     tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.~   "
222678|NCT00644020|"~     The investigation is a randomized, double-blind, placebo involved and multi-center clinical~     trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo~     group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with~     branch vein thrombosis. They receive investigational drug 40 days after resection surgery.~     Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.~   "
222679|NCT00644007|"~     The purpose of this study is to evaluate the efficacy and safety of SK3530 in men with ED and~     hypertension who were taking antihypertensive medication.~   "
222680|NCT00643994|"~     The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients~     with early stage organ-confined prostate cancer.~   "
222681|NCT00643981|"~     The purpose of this research study is to determine if the infusion of a combination of stem~     cells obtained from the bone marrow of the same patient will contribute to the formation of~     new blood vessels in patients with symptomatic severe coronary ischemia. In this trial we~     will study the safe use of this therapy and its effects on making new blood vessels will be~     evaluated.~      Coronary ischemia is intractable angina due to severe coronary artery disease which can~     seriously decrease blood flow to the heart.~      CI needs a comprehensive treatment since the condition will not improve on its own. The~     overall goal of the treatment is to increase blood flow to the heart and improve symptoms of~     angina.~      The study hypothesis is based on the concept that the process of formation of new blood~     vessels is complex and requires the participation of several types of stem cells and growth~     factors. The lack of any of these components will produce vessels which are immature and~     unable to provide appropriate blood supply to the heart.~      Patients eligible to participate in this study are those suffering from severe blockages to~     the vessels of the heart and are not candidates for percutaneous revascularization or~     surgical procedures.~      Once the final mixture of stem cells is prepared, the cells will be intracoronary infused~     through a catheter into the blocked vessel of the heart.~      Studies will be performed to evaluate if the intracoronary infusion of stem cells is safe,~     feasible and works.~      Patients will be evaluated for 6 months after cell transplant.~   "
222682|NCT00643968|"~     Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain~     plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)~      Main Secondary objectives:~      Comparison of the two arms for genotypic resistance profile in case of virological failure~      CD4 changes from baseline~      Evolution of the lipid profile and morphological changes in fat distribution, and safety~      Efficacy and genotypic profile data, results of lipid markers, morphological changes and main~     biological parameters~   "
222686|NCT00643916|"~     The purpose of this clinical trial is to describe the safety and immunogenicity of one or two~     doses of Menactra® (TetraMenD) administered in children less than 2 years of age.~      Primary Objective:~      To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when~     administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of~     one dose of Menomune® when administered to children aged 3 years to <6 years of age.~   "
222687|NCT00643903|"~     This study will evaluate the effectiveness of cognitive behavioral coping training in~     improving side effect management and treatment adherence in HIV-infected patients who are~     taking antiretroviral medications.~   "
222688|NCT00643890|"~     The purpose of this study is to determine the safety and efficacy of AAV-GAD gene transfer~     into the subthalamic nucleus (STN) region of the brain. This study involves the treatment of~     subjects with medically refractory Parkinson's disease (PD). The gene transfer product, a~     disabled virus with a gene called GAD, will be infused into the STN bilaterally using~     stereotactic surgical techniques. The overall goal of this approach is to normalize the~     activity of the STN and reduce the motor symptoms of PD.~      Because the change in UPDRS demonstrated a positive outcome, the sham surgery subjects from~     the blinded portion of the study will be invited to crossover into the Open-label Arm portion~     of the study. The Open-label Arm will further evaluate the safety and efficacy of AAV-GAD~     gene transfer into the subthalamic nucleus (STN) region of the brain.~   "
222689|NCT00643877|"~     The purpose of this study is to investigate whether preoperative hepatic and regional~     arterial chemotherapy are able to prevent liver metastasis and improve overall survival in~     patients receiving curative colorectal cancer resection.~   "
222690|NCT00643864|"~     The purpose of this project is to assess the effects of four weeks of mirror-box training on~     weakness of one arm secondary to stroke. Primary measures are function and strength.~     Secondary measures will evaluate muscle tone, flexibility, and the subject's perception of~     their everyday function and improvement. Research Hypothesis: For chronic upper limb~     hemiparesis secondary to stroke, four weeks of mirror-box training with movement of the~     unaffected limb only results in a mean increase of 10 points on the Fugl-Meyer Test of Motor~     Recovery (Upper Extremity).~   "
222691|NCT00643851|"~     The purpose of this clinical research study is to learn if initiating treatment with~     BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in~     patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes,~     when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety~     of this treatment will also be studied~   "
222692|NCT00643838|"~     A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the~     realization of dental cares. This openly clinical trial is done in 36 French primary care~     dental centers, especially on anxious and phobic patients but also on infants or mental~     deficient adults. At least 480 patients will be included in this clinical protocol.~   "
222693|NCT00643825|"~     This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay~     relapses in patients with glioblastoma compared to the standard care consisting in~     observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go~     arm).~   "
222694|NCT00643812|"~     Rates of suicide among young Alaska Native males are over ten-fold higher than among a~     similar age cohort in the rest of the United States. A high proportion of these deaths are~     associated with firearms. Firearms are an important part of the subsistence lifestyle of this~     population, however restriction of access to guns by youth may be a promising strategy to~     reduce the risk of suicides in this population. Previous research conducted in the first~     phase of this project has demonstrated that about 75% of homes in rural southwest Alaskan~     villages have guns, and only about 15% of these guns are locked; 6% are loaded.~      The aims of this specific phase of the study to execute a randomized trial of an intervention~     to improve firearm storage practices among residents of selected villages. Our hypothesis is~     that households receiving training and equipment to store firearms in gun lockers will be~     more likely to store their guns locked at 12 months, compared to households not receiving the~     intervention.~   "
222695|NCT00643799|"~     To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee~     osteoarthritis~   "
222696|NCT00643786|"~     The usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix~     (Kalinox 170 bar) during dental care is studied and the pollution resulting from~     administration of Kalinox is also investigated.~   "
222697|NCT00643773|"~     The purpose of this study is to determine whether long term leucine supplementation has a~     positive effect on body composition and muscle characteristics in elderly, type 2 diabetes~     patients.~   "
222698|NCT00643760|"~     The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262),~     hereafter referred to as GEn is effective in the treatment of neuropathic pain associated~     with diabetic peripheral neuropathy(DPN)~   "
222699|NCT00643747|"~     The purpose of the study is to determine whether gene therapy is safe and effective for the~     treatment of severe childhood blindness caused by mutations in RPE65.~   "
222700|NCT00643734|"~     The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release~     (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the~     treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and~     safety of both treatment regimens.~   "
222701|NCT00643721|"~     Evaluation of hydration status during exercise and heat exposure.~   "
222719|NCT00643487|"~     Anterior knee pain has been an enigmatic problem for orthopedic surgeons. Recent studies, as~     well as the clinical observation of the principle investigator have suggested that~     arthroscopic resection of the infrapatellar plica (IPP), a vestigial remnant from embryonic~     development of no known clinical or biological significance, may eliminate this pain. The~     mechanism whereby this pain is related to the IPP is unclear. This study will document the~     mechanical behavior of the IPP, its kinematics, as recorded on video among a group of~     subjects who are undergoing arthroscopy. Radiographic visualization of the observed behavior~     will be obtained by injection of contrast material, and then fluoroscopic recording of a~     standard series of motions. The plica will then be resected to avoid any possibility of~     residual symptoms related to its presence. Further fluoroscopy of the knee without plical~     attachment, will allow the kinematic behavior to be assessed. The procedure will then be~     terminated.~   "
222702|NCT00643708|"~     BACKGROUND: A new effective way, transvaginal ultrasound-guided ovarian interstitial~     laser-coagulation treatment, in management of anovulation in patients with polycystic ovary~     syndrome (PCOS), has been presented in the data published. But, the optimal number of laser~     coagulation points in the ovarian interstitial to be applied at the procedure is unclear.~     This clinic trial aims to explore an optimal laser dose for this new protocol. METHODS:~     Fifty-six PCOS women with clomifene citrate-resistant underwent ultrasound-guided~     transvaginal ovarian interstitial YAG-laser treatment. By random list table，all subjects were~     randomly divided into four groups in terms of the number of laser coagulation points made in~     their ovaries as follows: group A, one coagulation point per ovary; group B, two points;~     group C, three points; group D, four to five points. The size of each point was about 10 mm~     in diameter on the ovarian plane monitored by transvaginal ultrasound. Postoperative~     ovulation rate, pregnancy rate and some biochemical parameters were compared among four~     groups.~   "
222703|NCT00643695|"~     In this study, depressed veterans with hepatitis C will be randomly assigned to the control~     group or to the exercise intervention group. The exercise intervention is designed to begin~     slowly for most participants and to progress within each participant's target heart rate~     range for moderate intensity exercise. The exercise intervention is a 12 week home based~     walking program. Ideally individuals will walk for 30 minutes, at a moderate intensity, a~     minimum of three times per week. However, the duration and relative intensity will be~     tailored for each individual.~      Central Hypothesis Veterans who receive the exercise intervention will be significantly less~     symptomatic for depression than veterans in the control group.~   "
222704|NCT00643682|"~     The purpose of this study is to determine whether adding a simple educational card to~     standard pre-procedure instructions improves the quality of bowel preparation for~     colonoscopy.~   "
222705|NCT00643669|"~     The objective of this study was to describe the intraocular pressure-lowering efficacy of~     AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated~     control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP~     was measured every 4 hours, beginning at 8 AM for 24 hours.~   "
222706|NCT00643656|"~     A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the~     realization of liver biopsy in order to relax him and to reduce his pain during this painful~     medical treatment. This single investigator centre and national clinical trial is done~     blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of~     them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in~     this clinical protocol.~   "
222707|NCT00643643|"~     To investigate the relationship between the pharmacokinetics and pharmacodynamics of~     UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).~   "
222708|NCT00643630|"~     To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury~     to the skin~   "
222709|NCT00643617|"~     The purpose of this study is to investigate the effects of CyberKnife radiosurgery in~     patients with early stage organ-confined prostate cancer and to evaluate the effects of this~     treatment on the quality of life over time.~   "
222710|NCT00643604|"~     The purpose of this 8-week study is to compare the effects of switching from therapy with~     epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing~     to Remodulin will have on patient satisfaction with their treatment and impact on quality of~     life.~   "
222711|NCT00643591|"~     The objectives of the trial are:~        -  To determine the localisation within the primary tumor of the therapy resistant cells,~          before and during radiotherapy to determine a possible accurate boost volume.~        -  To determine changes during treatment intra- and extratumoral within the irradiated~          area.(Intratumoral: change of up-take - decrease, increase, change of localization/~          Extratumoral: effects of temporal changes in up-take - e.g. due to oedema).~   "
222712|NCT00643578|"~     The purpose of this study is to find out whether a difference between two doses of formoterol~     can be detected by methacholine challenge.~   "
222713|NCT00643565|"~     This open-label two-arm study will assess the safety and efficacy of a combination of~     bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in~     childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma~     soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard~     chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of~     induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1~     of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy~     with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time~     on study treatment is 1-2 years.~   "
222714|NCT00643552|"~     This project will evaluate muscle strength and its relationship to everyday function in~     individuals with Down Syndrome.~   "
222715|NCT00643539|"~     The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin~     pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin~     pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15~     years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were~     assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.~   "
222716|NCT00643526|"~     The main purpose of this study is to evaluate how well the autoinjector works in a group of~     people who are likely to use the autoinjector for injecting their medicine in the future.~     However, no active medicine is given by the autoinjector.~   "
222717|NCT00643513|"~     To study QoL related response, symptom spectrum and severity in disseminated breast cancer~     patients receiving Faslodex hormonal therapy.~   "
222718|NCT00643500|"~     Patients with partial-onset seizures seen in community-based practices were to be included in~     this therapeutic use study~        -  to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the~          favorable safety of the drug found during clinical development~        -  to obtain further information about optimal dosing in daily clinical practice. Compared~          to previous registration trials, the study population corresponded more closely to that~          seen in daily clinical practice.~   "
224311|NCT00622414|"~     This phase I trial is studying the side effects and best dose of aflibercept in treating~     young patients with relapsed or refractory solid tumors. Aflibercept may stop the growth of~     tumor cells by blocking blood flow to the tumor.~   "
222720|NCT00643474|"~     This randomized, parallel study compares 2 groups of type 2 non-insulin treated (NIT)~     diabetes patients using the Accu-Chek Aviva glucometers. One group (Intensive Group) will~     perform a 4-point daily glucose monitoring profile 3 times a week Monnier-based. These~     patients will also receive specific glycemic targets and suggestions on how to reach them~     following lifestyle recommendations. At the same time, investigators will use SMBG results,~     downloaded from glucometers, to improve patients' therapy. The second group (Control Group),~     will follow the SMBG standard care usually adopted in their centers. To be eligible, patients~     do not to have performed a previous intensive SMBG management (the execution of SMBG~     measurements used to modify lifestyle, diet or physical activity, in a systematic/structured~     manner and/or to manage therapeutic approach). The anticipated duration of the trial is 12~     months, and the target sample size is 1000 individuals.~   "
222721|NCT00643461|"~     The purpose of this study is to compare the clinical performance of three dental adhesive~     systems used to bond Class V cavity fillings in adult teeth.~   "
222722|NCT00643448|"~     Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at~     initiation of treatment and at steady state~   "
222723|NCT00643435|"~     Patient self-efficacy, or confidence in one's ability to take the necessary steps to achieve~     a goal, has been shown to influence a number of important health behaviors and outcomes.~     However, current ways of increasing patient self-efficacy are time and labor intensive and~     occur away from doctor visits, where most health care is delivered. We developed, and are~     testing in a study the effectiveness of a new way of teaching doctors how to talk to patients~     during office visits in a way that will boost their patients' self-efficacy for changing~     important health behaviors.~   "
222724|NCT00643422|"~     In this study the reproducibility of optical coherence tomography measurements should be~     evaluated.~   "
222725|NCT00643409|"~     The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin~     sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once~     a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to~     evaluate the safety of both treatments.~   "
222726|NCT00643396|"~     The majority of patients with small cell lung cancer have incurable extensive stage disease.~     The usual initial treatment for this condition is chemotherapy which produces responses in~     about 50-80% of patients. Despite this, the cancer usually returns. Once common body region~     where it re-grows is in the chest, which can cause symptoms such as shortness of breath,~     cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's~     quality of life and in some situation be life-threatening. In this study , we propose to give~     patients who have extensive stage small cell lung cancer which responds to chemotherapy~     radiotherapy treatments to the chest. By giving this type of radiation before the cancer has~     a chance to re-grow, we hope to control the disease within the chest and prevent future~     symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on~     the protocol will be checked regularly for disease control, quality of life and radiation~     side effects, if any.~   "
222727|NCT00643383|"~     A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and~     safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in~     patients between 18 and 80 yrs of age.~   "
222728|NCT00643370|"~     Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation~     treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In~     some situations, tumors move enough during breathing so that some or all of the tumor may be~     missed by a radiation treatment. One way to decrease the amount a lung tumor moves during~     radiotherapy treatments is for patients to held their breath briefly during a radiation~     treatment. By doing this, a patient's lung tumor may not move as much as it would during~     regular breathing. In this study, the investigators aim to study patients with lung cancers~     which move during breathing. Patients will be asked to hold their breath after inspiration~     while a CT scan of their lung tumor is obtained. The purpose of this study is to study how~     much less patients' lung tumors move when they hold their breath~   "
222729|NCT00643357|"~     The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over~     a period of three consecutive care procedures in burned children. It's a international~     (Spain, France, Tunisia and Belgium) study with 8 investigator centers.~   "
222730|NCT00643344|"~     The purpose of this study is to determine whether an innovative program that combines~     mindfulness-based stress reduction and mindful eating practices with diet and exercise~     guidelines (CALMM+ intervention) will lead to greater weight loss and more favorable body fat~     distribution than a conventional weight-loss program(Diet-Ex intervention).~   "
222731|NCT00643331|"~     This clinical trial aims to evaluate the effects of a 12 month gym- and home-based exercise~     program on bone density and falls risk factors in postmenopausal women with low bone density.~     It is hypothesised that the exercise program will lead to improvements in bone density and~     falls risk factors such as balance and muscle strength compared with usual care.~   "
222732|NCT00643318|"~     The purpose of this study is to assess the short and long-term outcomes after CyberKnife~     stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who~     are medically inoperable.~   "
222733|NCT00643305|"~     The purpose of this study is to determine whether motivational interviewing and skills~     building interventions reduce HIV risk behavior for adults with serious and persistent mental~     illness.~   "
222734|NCT00643292|"~     A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy,~     safety, and compliance of a single dose of azithromycin extended release compared with a~     10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent~     or recurrent ear infections~   "
222735|NCT00643279|"~     The purpose of this clinical research study is to evaluate the safety of an investigational~     implantable hemodynamic monitor (IHM). The IHM is implanted surgically under the skin in the~     upper chest area and records the force with which the heart pumps blood (heart pressures).~     This study will also determine how doctors use the information related to heart pressures in~     the management of heart failure.~   "
222996|NCT00639847|"~     This study compared an in-home asthma management program provided by nurses or respiratory~     therapists to see if those receiving program had fewer hospitalizations, clinic and emergency~     room visits and higher levels of satisfaction and health related quality of life.~   "
222736|NCT00643266|"~     We have developed a training intervention that successfully improves older adults' memory. We~     have also shown that older adults whose memory is as good as younger adults' memory (Hi-Old)~     use an altered pattern of memory-related brain activity compared to younger adults, whereas~     healthy older adults with poorer memory (Lo-Old) do not. We have also shown that individuals~     with amnestic Mild Cognitive Impairment (aMCI) have impairments of conscious, effortful,~     Recollection-based memory processes, whereas their automatic, Familiarity-based memory~     processes are intact. Our primary current goal is to investigate whether our successful~     memory intervention will improve Recollection and produce induce altered patterns of brain~     activity in the Lo-Old and aMCI.~      Young, Lo-Old, Hi-Old, and aMCI will be scanned using functional magnetic resonance imaging~     while performing two memory tasks. Half of the Lo-Old and half of the aMCI will then receive~     the memory intervention, while the other half in each group will receive a control program~     consisting of information and games about aging. The Lo-Old and aMCI will then be rescanned~     while performing the two memory tasks. We predict that the memory intervention will improve~     performance on a number of memory tasks, and will induce altered patterns of brain activity.~     In the Lo-Old, their brain activity after the memory intervention will look more like the~     Hi-Old, while brain activity will become more focal in the aMCI.~   "
222737|NCT00643253|"~     We will conduct a randomized, controlled trial of routine, pre-natal care practice-site based~     pre- and post-natal breastfeeding promotion interventions in low-income minority women, with~     stratification for maternal country of origin. Our primary outcome measure is breastfeeding~     duration and extent, i.e. intensity. Our secondary outcomes measures are: a) infant weight,~     and b) participant/ provider experiences of the intervention.~      The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study (PAIRINGS) trial~     randomizes women to a Prenatal Care Provider (PNC) + Lactation Consultant (LC) intervention,~     or Control group. The PNCs will use a brief, computer prompted protocol throughout pregnancy~     and at follow-up of maternal-infant dyads. The LC will meet women, one-on-one while pregnant,~     at daily hospital rounds, during well-infant care and (as needed) home visits. Post-partum~     interviews at 1,3 and 6 months will collect infant feeding data.~      Primary Outcomes (Hypotheses): Breastfeeding~        1. Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences, by~          treatment group, in BF intensity. Intensity will be assessed via 7 day recall of the~          frequency of breastmilk feedings vs. other liquids and solids.~        2. Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences, by~          treatment group, in the rate of exclusive BF.~           Secondary Outcomes (Hypotheses): Infant Growth~        3. Weight-for-Length, by Breastfeeding Intensity: There will be a significant association~          between BF intensity and weight-for-length z scores at 4,6,9, and 12 month well-child~          visits.~        4. Weight Gain, by Breastfeeding Intensity: There will be a significant association between~          BF intensity and weight gain from the 4th -12th month of age.~        5. Weight-for-Length, by Treatment Group: There will be a significant association between~          treatment group and weight-for-length z scores at 4,6,9, and 12 month well-child visits~        6. Weight Gain, by Treatment Group: There will be a significant association between~          treatment group and weight gain from the 4th - 12th month of age.~   "
222738|NCT00643240|"~     RATIONALE: Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing~     substances to them without harming normal cells. This may be effective treatment for~     leukemia.~      PURPOSE: This phase I trial is studying the best dose of yttrium Y 90-labeled monoclonal~     antibody BU-12 in treating patients with advanced relapsed or refractory acute lymphoblastic~     leukemia or chronic lymphocytic leukemia.~   "
222739|NCT00643227|"~     The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained~     release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g~     by mouth once daily, when used to treat adults with mild to moderate community acquired~     pneumonia (CAP), and that both treatments were safe.~   "
222740|NCT00643214|"~     To determine if Tetrix Cream,, when applied to the skin lesions on patients with contact~     dermatitis, slows or interferes with the healing of the lesions.~   "
222741|NCT00643201|"~     The purpose of this study is to evaluate the effects of an investigational blood thinner,~     apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep~     vein thrombosis (DVT) or pulmonary embolism (PE)~   "
222742|NCT00643188|"~     Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The~     incidence and prevalence of AF increase exponentially with increasing age and AF is~     associated with higher mortality, more frequent hospitalization, and lower quality of life.~     Furthermore, AF is often associated with heart failure. The majority of AF is initiated by~     ectopic foci found primarily in the pulmonary veins. It was shown that catheter ablation of~     those veins could eliminate episodes of AF. In patients with heart failure, catheter ablation~     could improve cardiac function, symptoms and quality of life. It remains still unknown~     whether AF ablation is more effective than conventional treatment in terms of mortality and~     morbidity.~   "
222743|NCT00643175|"~     Osteoporosis has been called a silent epidemic whose prevalence is increasing. It often~     presents as a fragility fracture, with hospitalizations resulting from minimally traumatic~     hip fractures. While the fractures are treated appropriately, the underlying pathology is~     often ignored. Numerous studies have shown that prior fracture increases the risk for further~     fracture. In 2004 the Surgeon General released a report on osteoporosis, the details of which~     include multi-disciplinary treatment of osteoporotic fractures. Treatment of osteoporosis~     after hip fracture is also being targeted as a future hospital quality assessment measure.~     Hospitals which have no plan in place to address osteoporosis treatment after hip fracture~     may be cited, and may have medicare money withheld. The goal of the study is to create an~     automated in-patient endocrinology consultation for osteoporotic hip fractures. We plan to~     gather patient data in a prospective manner including the endocrinologist recommendations,~     adherence to medical therapy after discharge, and future fracture rates. Possible planned~     interventions include only appropriate medical therapy for osteoporosis, DEXA bone scanning,~     and regularly scheduled telephone follow-up.~   "
222759|NCT00642967|"~     This single arm study will assess the efficacy and safety of monthly administration of~     subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients~     with chronic renal anemia, not on dialysis. Patients currently receiving treatment with~     subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of~     Mircera, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose~     of ESA previously administered. The anticipated time on study treatment is 3-12 months, and~     the target sample size is 100-500 individuals.~   "
222760|NCT00642954|"~     The purpose of this Phase I study of vorinostat in combination with lenalidomide and~     dexamethasone in participants with relapsed or refractory multiple myeloma is to determine~     the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The safety and~     tolerability of the combination regimen will also be evaluated in this study.~   "
222828|NCT00642070|"~     This study is being done to identify those elements of the immune response that may~     predispose a woman to recurrent urinary tract infection. We suspect that lesser effectiveness~     of certain components of the host response will lead to recurrent urinary tract infection. We~     will also evaluate the role that the bladder reservoir may play in recurrent urinary tract~     infection.~   "
222744|NCT00643162|"~     Depression is a common and disabling condition which represents a substantial public health~     concern, especially with the aging of the population in general. In fact, one to four percent~     of the older population has major depression. Although medication is the main treatment for~     depression, studies show that only 50% of patients show a significant response to treatment.~     The response might actually be less in older subjects, and with more adverse side effects due~     to changes in the metabolism of the older population as well as drug interaction. For these~     reasons (changes in metabolism and possible drug interactions) the starting dose of the~     antidepressant Lexapro will be 5mg, instead of 10mg.~      To combat the incomplete response to medication, many combined and augmentation strategies~     have been developed. Examples of this would be an antidepressant medication plus a~     neuroleptic medication; or an antidepressant medication plus talk therapy. One non-medication~     treatment that is being considered is massage therapy. Recent data suggest that massage~     therapy can be useful for the treatment of depression.~      This study proposes to perform a controlled trail to assess the effects of massage therapy on~     symptoms of depression in older subjects with major depression. All of the subjects will~     receive Lexapro, which is an FDA approved medication for the treatment of depression. Half of~     the subjects will receive Swedish massage for one hour, twice a week, and the other half will~     receive light touch for one hour, twice per week for eight weeks. Standardized rating scales~     that evaluate depression will be used to evaluate the subjects mood.~   "
222745|NCT00643149|"~     The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and~     effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12~     hours) when used to treat children with strep throat.~   "
222746|NCT00643136|"~     The purpose of this study is to determine the effects of pregabalin on sleep problems in~     patients with seizures.~   "
222747|NCT00643123|"~     The purpose of this study is to investigate the efficacy of allopurinol as an augmentation~     agent for treatment resistant mania and mixed mania.~   "
222748|NCT00643110|"~     Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets~     without raising blood sugars too much the way that orange juice or glucose tablets sometimes~     do.~   "
222749|NCT00643097|"~     RATIONALE: Vaccines made from a peptide may help the body build an effective immune response~     to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white~     blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy~     after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients~     with newly diagnosed glioblastoma multiforme.~   "
222750|NCT00643084|"~     Research Question: Are anastomotic leak and surgical site infection rates equivalent in~     patients having laparoscopic bowel resections without bowel preparation vs those having bowel~     preparation?~      Bowel preparation is a distressing and uncomfortable procedure for patients undergoing~     laparoscopic colorectal surgery, and also carries some risk of morbidity due to dehydration,~     electrolyte inbalance and possible infectious complications. If it is found that there is no~     difference between those patients who have preoperative bowel preps and those who do not have~     them, then we can save these patients this additional distress and risk at the time of their~     surgery.~   "
222751|NCT00643071|"~     Patients with severe refractory ulcerative colitis (UC) or those who received placebo in~     study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy~     will be evaluated.~   "
222752|NCT00643058|"~     The purpose of the study is to determine the role of nitric oxide (NO) in asthma and to~     characterize the symptoms associated with inhaled endotoxin (lipopolysaccharide [LPS]) in~     normal subjects. In this study, we will determine the effect of inhaled endotoxin on exhaled~     NO in healthy African Americans, with and without NOS2 promoter polymorphisms. The protocol~     described in this submission will involve the use of NIH Clinical Center Reference Endotoxin~     which has been approved by the FDA under IND BB-IND-10035.~   "
222753|NCT00643045|"~     To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200~     mg/day and Low Dose: 50 to 100 mg/day) orally, as compared to Placebo, as add-on therapy in~     patients with early idiopathic Parkinson's disease who are currently receiving a stable dose~     of a single dopamine agonist. It is hypothesized that, over a 24-week period, add-on~     treatment with safinamide will result in greater improvement of motor symptoms in these~     patients, compared to treatment with a dopamine agonist alone.~   "
222754|NCT00643032|"~     We wish to study which method of local injection of analgesic (before or during surgery) is~     the more effective method to reduce post-operative pain in children. In addition, we wish to~     study which pre-operative educational intervention is more effective in reducing anxiety in~     children and their family.~   "
222755|NCT00643019|"~     This trial randomizes young Mexican American and African American women with a sexually~     transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus~     control with the goal of preventing recurrent sexually transmitted infections.~   "
222756|NCT00643006|"~     The study aims to compare low-intensive and high-intensive physical exercise and its impact~     on physical function, pain and signs of inflammation.~   "
222757|NCT00642993|"~     The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and~     overweight participants. The primary measure of effectiveness is the change in body weight~     during treatment. Additional measures include waist circumference and body mass index (BMI).~     In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated.~     The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that~     with placebo with respect to the primary efficacy variable.~   "
222758|NCT00642980|"~     Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an~     increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to~     reduce the risk of prematurity have not found a statistically significant diminution of risk~     (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of these~     findings is that some of these treatment were administered vaginally, most often during the~     second or third trimester~      Aim: To reduce the frequency of late abortions and very preterm birth by prescribing~     clindamycin vs placebo to patients diagnosed with BV before 13 weeks.~   "
224331|NCT00622128|"~     The purpose of this study is to develop and pilot test and non-pharmacological intervention~     designed to prevent the occurence of aggression in persons with dementia.~   "
222761|NCT00642941|"~     This study will evaluate the efficacy and safety of R1507 in participants with recurrent or~     refractory sarcoma. Eight cohorts of sarcoma participants will be studied in parallel. Cohort~     1: Ewing's sarcoma primary cohort defined as participants who have relapsed less than or~     equal to (<=) 24 months from diagnosis, received at least two prior chemotherapy programs and~     are unresectable. Cohort 2: Ewing's sarcoma non-primary (secondary) cohort defined as~     participants who have relapsed greater than or equal to (>=) 24 months from diagnosis or have~     only received one prior chemotherapy program. Cohort 3: Expanded Ewing's sarcoma defined as~     participants with recurrent or relapse regardless of prior number of salvage regimens and~     regardless of time of relapse. Cohort 4: participants with osteosarcoma. Cohort 5:~     Participants with synovial sarcoma. Cohort 6: Participants with rhabdomyosarcoma Cohort 7:~     Participants with alveolar soft part sarcoma (7a), desmoplastic small round cell tumors (7b),~     extraskeletal myxoid chondrosarcoma (7c), clear cell sarcoma (7d), myxoid liposarcoma (7e).~     Cohort 8: Participants with unspecified sarcoma diagnosis. Participants in the expanded~     Ewing's sarcoma Cohort 3 will receive 27 milligrams (mg)/kilogram (kg) every 3 weeks~     intravenously (IV). All other participants will receive R1507 9 mg/kg IV weekly. The~     anticipated time on study treatment is until disease progression or unacceptable adverse~     events, withdrawal or death.~   "
222762|NCT00642928|"~     The objective of this trial is to define the minimum effective dose of BF 2.649 between 5 mg,~     10 mg, 20 mg or 40 mg versus placebo in reducing the Excessive Daytime Sleepiness of~     Parkinson's disease patients~   "
222763|NCT00642915|"~     To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood~     glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the~     ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination~     therapy~   "
222764|NCT00642902|"~     To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces~     central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as~     assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study~     medication is administered via subcutaneous (under the skin) injections.~   "
222765|NCT00642889|"~     To determine the long-term safety and efficacy of a dose range of safinamide of 50-200~     mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic~     Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA)~     agonist.~   "
222766|NCT00642876|"~     The purpose of this clinical investigation is to evaluate the safety and effectiveness of the~     ACD in the single level surgical treatment of patients with symptomatic cervical degenerative~     disc disease. The primary follow-up information obtained from this clinical investigation are~     used to support a PMA application for the ACD.~   "
222767|NCT00642863|"~     It is common in many populations that babies develop iron deficiency or iron deficiency~     anemia (that is, too few healthy red blood cells due to lack of iron). This is due to rapid~     growth in infancy combined with limited sources of iron in the infant diet. The amount of~     iron the baby receives across the placenta during pregnancy is another important factor. This~     study focuses on infants who are born with less than the usual amount of iron in their~     bodies. The purposes of the study are to assess effects of lower iron at birth on infant~     behavior and development and to determine if providing iron supplements to such infants~     beginning at 6 weeks fosters healthier development. Another part of the study will determine~     the effects of iron deficiency anemia at different times during infant development.~   "
222768|NCT00642850|"~     This single arm study will assess the efficacy, safety and tolerability of once-monthly~     administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis~     participants with chronic renal anemia. Participants will receive monthly intravenous~     injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the~     dose of epoetin administered in the week preceding first study drug administration. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
222769|NCT00642837|"~     The objective of this observational study is to assess improvement of quality of life in the~     patients who are administered Tramadol 37.5mg/Acetaminophen 325mg tablets for 10~14 weeks~     according to the investigator's discretion in clinical practice.~   "
222770|NCT00642824|"~     This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive~     relationship between mRNA BRCAI levels and the response to different chemotherapy~     combinations plus Avastin. A subset of patients participating in MO19390, and receiving~     Avastin 15mg/kg iv on day 1 and subsequently once every 3 weeks, will undergo BRCAI mRNA~     expression determination. Depending on the BRCAI mRNA level (low, medium or high) they will~     receive a different chemotherapy regimen in combination with Avastin:~     a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or~     docetaxel. Avastin treatment will continue after completion of chemotherapy cycles until~     disease progression, and the target sample size is 100-500 individuals.~   "
222771|NCT00642811|"~     The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet~     medication, affects platelets. Anti-platelet agents are medications that block the formation~     of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding,~     but when they form inside the arteries their formation is linked to a risk of medical~     problems such as heart attack and stroke. This study investigated the effect of Ticagrelor on~     inhibition of platelet aggregation compared with clopidogrel in patients previously~     identified as non-responsive to clopidogrel.~   "
222772|NCT00642798|"~     To support the registration of sitagliptin 100mg in china.~   "
222773|NCT00642785|"~     The research question to be addressed is whether indirect phototherapy based activation of~     the body's alternative cellular energy (ACE) pathway will lead to expedited healing of active~     herpes simplex virus (HSV) and herpes zoster virus (HZV)skin lesions, and also possibly~     inhibit both latent HSV infections and residual HZV infections.~   "
222811|NCT00642291|"~     To obtain safety and efficacy data for antiretroviral regimens containing emtricitabine in~     HIV-1 infected pediatric subjects. To determine emtricitabine concentrations in HIV-1~     infected pediatric subjects and, if necessary, to refine the dose of emtricitabine to achieve~     concentrations comparable to those in adults given 200 mg emtricitabine once-daily.~   "
222812|NCT00642278|"~     The purpose of this study is to evaluate the effectiveness, safety, and tolerability of~     JNJ-28431754 compared with placebo in patients with type 2 diabetes.~   "
222774|NCT00642772|"~     Osteoarthritis (OA) is a common cause of pain and disability. Physical therapy is a key part~     of treatment for OA, but VA Medical Centers are often limited in their capacity to provide~     physical therapy services for veterans with knee OA. The goal of this study is to perform a~     preliminary work on a group-based physical therapy program for veterans with knee~     osteoarthritis (OA), in preparation for a larger project. This work will allow us to assess~     the feasibility of conducting group-based physical therapy program and to plan a larger grant~     submission based on the findings of this initial study. We hypothesize that the group-based~     program will be feasible to administer and will result in improved pain and function.~   "
222775|NCT00642759|"~     The purpose of this research study is to learn more about whether the combination of drugs~     carboplatin, Abraxane and Avastin helps treat non-small cell lung cancer (NSCLC). One of the~     standard treatments for advanced NSCLC is the combination of the drugs carboplatin,~     paclitaxel and Avastin. Paclitaxel can be associated with severe side effects that may make~     the treatment difficult to tolerate. Some of these side effects are caused by the solution~     used to dissolve paclitaxel before it can be administered. Abraxane is a different form of~     paclitaxel that does not need to be dissolved by this solution. Abraxane is approved for the~     treatment of breast cancer but is not approved to treat NSCLC. We will also be trying to~     learn more about how the drug Avastin may work to treat cancer.~   "
222776|NCT00642746|"~     The purpose of this study is to see if alternating chemotherapy with erlotinib increases~     tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be~     studying the side effects (good and bad) of alternating chemotherapy with erlotinib on~     metastatic colorectal cancer.~   "
222777|NCT00642733|"~     This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in~     patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will~     receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8~     weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study~     treatment is until disease progression, and the target sample size is <100 individuals.~   "
222778|NCT00642720|"~     Study Synopsis Study Title: Double blind, single centre, cross-over study on the effects of~     weekly subcutaneous administration of 40 mg pegvisomant or placebo on quality of life and~     insulin sensitivity in acromegalic patients with normal serum IGF-I concentrations during~     long-term treatment with long-acting somatostatin analogs~      Study Objectives:~        1. To determine whether the addition of weekly pegvisomant administrations improves quality~          of life~        2. To determine whether the addition of weekly pegvisomant administrations improves insulin~          sensitivity~      Study Population: Acromegalic patients, who have normalized their serum IGF-I levels down to~     the upper 25 centiles of normality during long-term treatment with monthly injections of a~     long-acting somatostatin analogue Number of Subjects: 20~      Procedures:~        -  Patients on treatment with Sandostatin LAR (SL) 20 - 30 mg per months i.m. or patients~          on treatment with Lanreotide autosolution (LA) 90 - 120 mg deep s.c. will be enrolled.~        -  For 4 months, all subjects will also receive weekly s.c. injections of either placebo or~          a fixed dose of 40 mg pegvisomant~        -  After a 4 weeks wash-out period, patients will switch from either placebo to pegvisomant~          or from pegvisomant to placebo~        -  Before, and after 2 and 4 months of each treatment period, serum efficacy parameters and~          quality of life (AcroQol ™/ PASQ™) will be assessed.~        -  Before and after 4 months of each treatment period, pituitary tumor size and insulin~          sensitivity (HOMA/SIGMA model) will be assessed. Duration of study: 9 months~      Hypothesis:~      •We postulate that co-administration of the growth hormone receptor antagonist pegvisomant~     will improve QoL and insulin sensitivity~   "
222779|NCT00642707|"~     The purpose of this study is:~        1. To assess the antiviral activity of PRO 140~        2. To assess the safety and tolerability of PRO 140~        3. To generate additional PK, PD and safety data of PRO 140~   "
222780|NCT00642694|"~     Hypothesis I: Patients in the SSRI + ramelteon treatment group will achieve remission~     (defined as an IDS-C30 score of 11 or less) more quickly than those in the SSRI + placebo~     group.~   "
222781|NCT00642681|"~     Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge~   "
222782|NCT00642668|"~     This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene~     glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for~     correction and/or maintenance of hemoglobin levels in participants with chronic kidney~     disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA)~     or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy~     polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram~     (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size~     was 200 individuals.~   "
222783|NCT00642655|"~     The purpose of this study is to examine the safety and efficacy of IVIG in combination with~     Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a~     transplanted organ in patients who are highly HLA-sensitized and are awaiting~     transplantation.~   "
222784|NCT00642642|"~     The purpose of this study is to evaluate the safety profile and the treatment effect of~     Isolagen TherapyTM and placebo when administered to facial acne scars.~   "
222785|NCT00642629|"~     It is not fully clear how rheumatoid arthritis originates and develops, but it is understood~     that multiple genetic and environmental factors interact to trigger its onset. The immune~     system attacks the joint synovium, which damages the cartilage and bone in the joint by~     increasing the number of inflammatory cells and forming new blood vessels in the joint space.~     STA-5326 mesylate inhibits the production of IL-12 and IL-23 and therefore may inhibit Th-1~     cytokine production. A reduction in the Th-1 response has the potential to minimize or~     eliminate joint damage caused by the immune response in rheumatoid arthritis. This study is~     designed to assess whether the proposed mechanism of action is associated with a reduction in~     inflammation in the synovium of patients who have rheumatoid arthritis.~   "
222786|NCT00642616|"~     Examine the effects of TI in combination with an anti-diabetic regimen including inhaled~     insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary~     safety~   "
222997|NCT00639834|"~     The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate~     is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in~     the severity patients' arthritis will also be analysed.~   "
222787|NCT00642603|"~     This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of~     Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12~     cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were~     randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and~     oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to~     receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment~     was until disease progression, and the target sample size was 100-500 individuals.~   "
222788|NCT00642590|"~     Researchers believe that certain lifestyle factors can influence a couple's ability to~     conceive and have a baby. The ISIS Study will look at the health habits of couples who are~     planning their first pregnancy, and then attempt to measure the effect these habits have on~     the couple's fertility. The ISIS Study hopes to clarify the link between lifestyle and~     fertility, and believes that information gained in this project may help future couples in~     their attempts to conceive.~   "
222789|NCT00642577|"~     This 2 arm study will assess the efficacy and safety of Avastin in combination with~     irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid~     alone, as first line treatment in Chinese patients with metastatic colorectal cancer.~     Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2~     weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for~     4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil~     500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease~     progression, and the sample size is 100-500 individuals.~   "
222790|NCT00642564|"~     The purpose of this study is to collect data from patients who are diagnosed with epilepsy~     and are followed up in epilepsy clinics.~   "
222791|NCT00642551|"~     From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective~     cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and~     matrix-Gla protein (in the arterial vessel wall). The question remains whether~     supplementation with MK-7 also leads to measurable improvements of bone and vascular health.~     The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently~     healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of~     an MK-7- supplement will be monitored during three years on bone quantity and quality and on~     vascular characteristics and function.~   "
222792|NCT00642538|"~     20 eligible subjects will be enrolled into the treatment phase of the trial.~   "
222793|NCT00642525|"~     Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow~     is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be~     superior. This is the first study to compare radiographic contrast study and endoscopy for~     the identification of local complications after subtotal esophagectomy.~   "
222794|NCT00642512|"~     The primary purpose of the study is to determine the efficacy of oral dronabinol versus~     standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced~     nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea~     and vomiting and/or retching following administration of moderate-to-high emetogenic~     chemotherapeutic agents.~   "
222795|NCT00642499|"~     The primary purpose of this study is to determine if dronabinol is effective in preventing or~     treating nausea caused by HAART (highly active anti-retroviral therapy) in HIV and AIDS~     patients~   "
222796|NCT00642486|"~     This multi-site project compares compares the efficiency of a home-based portable monitoring~     strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive~     airway pressure treatment of obstructive sleep apnea in adults.~   "
222797|NCT00642473|"~     This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%)~     topical cream in the prevention and treatment of rash associated with Tarceva treatment, in~     participants with non-small cell lung cancer. The first cohort of participants enrolled in~     the study will be treated twice daily with metronidazole cream on the right side of the face~     and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily).~     The corresponding body parts on the left side will be treated according to local standard~     procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated~     participants will only receive twice daily treatment with metronidazole cream if and when~     they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The~     anticipated time on metronidazole treatment is less than (<) 3 months, and the target sample~     size is <100 individuals.~   "
222798|NCT00642460|"~     This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in~     patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate~     clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be~     randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients >=30kg,~     or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will~     be continued throughout. After 12 weeks of double-blind treatment, all patients will have the~     option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra~     for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which,~     for patients who meet specific criteria, an optional alternative dosing schedule decreasing~     the study drug administration frequency will be introduced. Anticipated time on study~     treatment is up to 5 years.~   "
222799|NCT00642447|"~     to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease~     dyspnea and improve physiologic and respiratory measures in patients with a previous exposure~     to Sulfur Mustard gas.~   "
222800|NCT00642434|"~     The purpose of this study is to determine if there are differences, (benefits) between~     carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes.~     Specifically we will be looking at differences in blood pressure and blood sugar control,~     endothelial function, inflammation, oxidative stress and coagulation.~      Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each~     subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done,~     Inflammatory and oxidative stress markers will be measured. Endothelial function will be~     measured using brachial artery ultrasound and laser skin Doppler~   "
222801|NCT00642421|"~     The purpose of this study is to assess the safety profile of a new prolonged release~     formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or~     6 weeks in acromegalic patients.~   "
222802|NCT00642408|"~     Intrauterine Growth Retardation is the most important determinant of mortality and morbidity~     in the neonatal period. It is also a very important factor in predicting nutritional status,~     health and development in childhood. It even influences health in adult life, contributing to~     the vicious cycle of disease and poverty. The high rate IUGR in DCs represents therefore a~     major public health problem. Maternal malnutrition is usually assumed to be a major~     determinant of the problem in these countries. An increasing amount of evidence points to the~     potential role played by micronutrient deficiencies during pregnancy. The adverse effect on~     birthweight of maternal iron deficiency anaemia, lack of zinc and lack of iodine have been~     documented. A similar effect is suspected for Vitamin A, Magnesium, Calcium, Copper,Thiamine,~     Pyridoxine and Folic acid. It seems that not one specific deficiency alone is responsible for~     this adverse effect, but rather a combination of them. Therefore, it is expected that~     covering needs of pregnant women by a multivitamin-mineral supplement will have an effect of~     public health importance on children's health.~      This study has the objective of improving children's health by preventing intrauterine growth~     retardation through the provision of multivitamin-mineral supplements during pregnancy.~      This research includes 2 constituents:~        1. a pilot phase during which socio-anthropological, nutritional and epidemiological~          aspects of IUGR will be assessed through qualitative and epidemiological methods.~        2. a double-blind, randomised, placebo-controlled trial, including 1215 pregnant women~          aimed at testing 3 hypotheses: supplementing pregnant women with a multivitamin-minerals~          mix will improve fetal growth; improved fetal growth will have a positive effect on~          health and growth during infancy; covering nutritional needs of lactating women with a~          multivitamin-minerals mix during 3 months after delivery will improve health and growth~          of infants.~      The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz,~     which plays a leader role in research and services providing at the district level and in~     policy recommendations at the national level. This will ensure that the study findings are~     incorporated into on-going district programmes with possible replication at the national~     level. The research lasts from June 2003 to October 2006.~   "
222803|NCT00642395|"~     Intensification with autologous stem cell (ASCT) is currently the most effective treatment~     for subjects under 65 and the essential goal is to achieve complete response (CR) or very~     good partial response (VGPR= greater than 90% reduction of monoclonal component). However,~     only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of~     disease.~      Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of~     Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade~     potentiates the antimyeloma effect of Melphalan without inducing any common toxicity.~      This study will be conducted in patients under the age of 65 with de novo multiple myeloma or~     in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion~     (radiological)and no contraindication to intensification. The primary objective will be to~     increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell~     transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%,~     61 patients will be included.~      Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning~     regimen, the progression-free survival and the overall survival after intensification.~     Response rates will be evaluated according to the response criteria defined by. Analysis will~     be performed on an intention-to-treat basis.~      After conventional induction therapy and PBSC collection, patients will be offered this new~     conditioning regimen. they will be free to refuse this regimen, in which case they will~     receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem~     cell transplantation.~      Evaluation will occur at 3 months post intensification.~   "
222804|NCT00642382|"~     The purpose of this study is to determine whether Agilus is safe and effective in the~     treatment of mild to moderate ankle osteoarthritis.~   "
222805|NCT00642369|"~     This study will apply polysomnography (PSG) to evaluate the effect of quetiapine fumarate on~     sleep architecture. Most of previous studies evaluated sleep by self-reported questionnaires~     during the antipsychotic treatment (clozapine, risperidone, olanzapine, et al), while only a~     few studies with PSG evaluation had some limitation, such as: small sample size, respective~     or cross-sectional, potential sleep disorders, et al. In this study, we will investigate both~     subjective and objective effect of quetiapine fumarate in improving sleep quality in~     schizophrenic patients by PSG as well as psychiatric scales. The control drug in this study~     is the typical antipsychotic - haloperidol. It could increase sleep duration and efficiency~     by mostly increasing the S2 without effect on rapid eye movement (REM) sleep and slow wave~     sleep (SWS). The patients will be randomised into two groups as a parallel design. This study~     is designed as rater blinded to reduce the bias in evaluation. It is suggested that the~     sedative effect of quetiapine fumarate could diminish in 2 weeks, therefore, we use 4 weeks~     to ensure the change of sleep quality in this study, which could be helpful for the~     evaluation of relative short and middle term effect of quetiapine fumarate on sleep quality.~   "
222806|NCT00642356|"~     The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to~     the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose~     wearing off in persons who have Parkinson's disease.~   "
222807|NCT00642343|"~     The purpose is to test the balance of children with unilateral,bilateral cochlear implants~     and patients having unilateral implants before,bilateral implants after surgery,using the~     Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect.~   "
222808|NCT00642330|"~     it is a prospective randomized simple-blinded pilot trial with the principal aim to compare~     efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative~     closure of PDA in very low birth weight infants. The likelihood of ductal closure with only~     one or two doses of treatment is a secondary objective.~   "
222809|NCT00642317|"~     The overall goal of this study is to identify and understand the environmental~     characteristics associated with tobacco use and tobacco initiation among Asian American youth~     from primarily two communities: Chinese and Vietnamese. The specific aims of this study are~     twofold:~        -  To estimate the prevalence of smoking among Chinese and Vietnamese youth in the Houston~          area compared with non-Asian American communities.~        -  To study the relationship between environmental characteristics (both pro- and~          anti-tobacco) and tobacco initiation and use among Chinese and Vietnamese youth.~        -  To explore if degree of acculturation is related to tobacco initiation and use among~          Chinese and Vietnamese youth.~   "
222810|NCT00642304|"~     This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when~     administered for the maintenance of hemoglobin levels in participants with chronic renal~     anemia, not on dialysis. Participants currently receiving maintenance treatment with~     subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A.,~     with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from~     the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study~     start.~   "
242023|NCT00386646|"~     To compare if 0.5% carboxymethylcellulose with 0.005% SOC (Stabilized oxychloro complex) have~     the same effectiveness and safety as 0.5% carboxymethylcellulose on dry eye patients.~   "
222814|NCT00642252|"~     The primary goals of this project are to determine the anticaries benefits of a prototype~     multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a Ca through the~     remineralization of enamel white-spots (non-cavitated lesions). The selection of patients~     with pre-existing white-spot lesions will permit an opportunity to evaluate the efficacy of~     the multi-mineral mouthrinse in reminerzalizing and/or inhibiting progression of enamel~     white-spot lesions.~   "
222815|NCT00642239|"~     This multicentered clinical trial is going to find out the radio-sensitization action of~     sodium glycididazole in radiochemotherapy for esophageal cancer.~   "
222816|NCT00642226|"~     The purpose of this study is to determine whether pars plana vitrectomy in combination with~     triamcinolone acetate is effective in the treatment of macular edema due to branch retinal~     vein occlusion.~   "
222817|NCT00642213|"~     Our primary goal is to study temporal trends in the incidence rate, causes, treatment, and~     outcome of stroke among a large biracial metropolitan population of 1,349,351, of whom~     215,611 (15%) are black (2000 Census). Such data are critical for the planning, intervention,~     and evaluation of public health efforts to decrease the mortality and morbidity due to stroke~     in the United States.~      We have completed this goal for 1993-94, 1999, 2005, and 2010. We ware in the process of~     collecting this data for 2015. In the 2015 study period we will also be ascertaining 3 year~     recurrence rates for all incident stroke events.~   "
222818|NCT00642200|"~     The study aims at detecting possible differences between an open (Lichtenstein) and a~     video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences~     monitored are further recurrence and chronic pain as well as primary complications.~   "
222819|NCT00642187|"~     A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently~     approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have~     asthma and are currently being treated with inhaled steroids. In addition the study evaluated~     the functionality of the new inhaler at the end of its intended life.~   "
222820|NCT00642174|"~     This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator~     controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers.~     The study will compare platelet function following a prasugrel loading dose and 1 week of~     prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose~     clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who~     have coronary artery disease. Various assays of platelet function will be used in this study.~     Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12,~     Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein~     (VASP), and Thromboelastography (TEG)-platelet mapping.~   "
222821|NCT00642161|"~     A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently~     approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents~     who have asthma. In addition the study evaluated the functionality of the new inhaler at the~     end of its intended life.~   "
222822|NCT00642148|"~     Phase IIa, randomised, double-blind, double-dummy, parallel group, multi-centre study in~     subjects diagnosed with moderate chronic obstructive pulmonary disease (COPD). The primary~     objective is to evaluate the effects of 12-weeks of treatment with GW856553 7.5 mg twice~     daily (BID) compared with placebo on the percentage of sputum neutrophils at 12 weeks. Twelve~     weeks of treatment with SERETIDE 50/500 BID will be compared with placebo for effect on~     sputum neutrophils as a positive control arm in the study~   "
222823|NCT00642135|"~     Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult~     to obtain, because of the non mature iris sphincter. The fundus is essential to detect~     retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim~     of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two~     mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study~     will evaluate the mydriasis in premature newborns, neonates and infants justifying a~     mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus~     reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic~     insert Mydriasert® can control drug dispensation and decrease the number of nurse~     interventions to obtain mydriasis in patients.~   "
222824|NCT00642122|"~     A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when~     given to asthma patients aged 12 years and above.~   "
222825|NCT00642109|"~     The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a~     well established technique for treating female stress urinary incontinence in patients with~     (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently,~     several anatomical approaches are developed and investigated to simplify this minimal~     invasive technique and make it safer. While the retropubic approach consists of the passage~     of the needles from under the midurethra up behind the pubic bone through the cavum retzii,~     the transobturator technique traverses the foramina obturatoria. Intraoperative complications~     like bladder perforation (in 4%) can be treated conservatively, while postoperative~     complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary~     retention) are troublesome, impair the quality of life and require occasionally surgical~     sling release (transection of the sling). The aim of this study is to compare quality of~     life, postoperative voiding dysfunction, success rates and tape position after retropubic and~     transobturator sling procedure.~        -  Trial with surgical intervention~   "
222826|NCT00642096|"~     The purpose of this research study is to determine if treatment with the combination of~     metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure~     than treatment with either of the two drugs alone. The study will also determine which~     combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering~     blood pressure (without unacceptable side effects), and whether it is possible to combine~     both drugs in a single tablet to simplify blood pressure treatment.~   "
222827|NCT00642083|"~     The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the~     prevention of outflow re-stenosis in loop fistula in a prospective trial.~   "
222888|NCT00641264|"~     The primary purpose of this study was to establish the psychometric properties of a new~     disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the~     questionnaire that were evaluated were: validity, reliability, and responsiveness to change~     (as a measure of treatment effect).~   "
222829|NCT00642057|"~     Although the results of studies looking at tetrabenazine have shown its effectiveness in the~     management of hyperkinetic(too much) movement disorders, it has not been made available in~     the U.S. The drug must be obtained from Cambridge Laboratories, the distributor, using an~     individual IND (#16,161). The cost of the drug is passed on to the patient. The purpose of~     the protocol is to provide an efficacious drug, with few side effects, in an attempt to get~     rid of a variety of incapacitating dyskinesias (abnormal movements).~   "
222830|NCT00642044|"~     Cross-linking of the cornea increases the mechanical and biochemical stability of the stromal~     tissue. The purpose of this study is to assess the effectiveness of riboflavin-ultraviolet~     light induced cross-linking of corneal collagen in improving visual acuity and reducing~     progression of keratoconus in the Brazilian population.~   "
222831|NCT00642031|"~     Primary objective:~      To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM~     (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly~     schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic~     malignancies;~      To determine the pharmacokinetics (PK) of Triciribine following study drug administration.~      Secondary objective:~      To observe the anti-tumor effects of Triciribine, if any occur~   "
222832|NCT00642018|"~     The primary purpose of this study is to determine whether LY2181308 in combination with~     docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.~   "
222833|NCT00642005|"~     Laparoscopic surgery allows surgeons to remove bowel via small incisions. To allow insertion~     of a camera and instruments, cold and dry gas is blown into the abdominal cavity. This~     project investigates the use of warmed, humidified gas in laparoscopic surgery. The~     hypothesis is that this will result in less damage to internal surfaces, and shorten recovery~     time. Previous studies have demonstrated positive outcomes in laparoscopic gallbladder~     operations. The investigators plan to study patients undergoing laparoscopic colon~     operations, as these operations are longer and the effect of humidification will be~     magnified. The investigators will enroll 74 patients: 37 will have the operation with cold~     dry gas, and 37 will have warm, humidified gas. The investigators will measure intraoperative~     heat loss, postoperative pain, fatigue, nausea and vomiting, and time to return of bowel~     function.~   "
222834|NCT00641992|"~     Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually~     the factors for predicting failure in the medical treatment are not clear. We conducted trial~     for determining the clinical value of paraclinical factor in this issue.~   "
222835|NCT00641979|"~     The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua~     (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the~     symptoms of seasonal allergic rhinitis (SAR).~   "
222836|NCT00641953|"~     The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to~     that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the~     feet.~   "
222837|NCT00641940|"~     This is a pilot study of the Girls in Transition (GT) program, an intervention designed to~     promote resilience and reduce gender-related risk factors for depression. The goal of the~     study is to gather preliminary data on the effects of the GT program.~   "
222838|NCT00641927|"~     This study examines the relative safety and benefit of antidepressant therapy (versus~     recommended mood stabilizer therapy)of bipolar type II major depressive episode. We~     hypothesize that antidepressant therapy will be superior to mood stabilizer therapy with~     little or no difference in treatment emergent manic symptoms.~   "
222839|NCT00641914|"~     A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma.~     Patients will receive either Pulmicort or a non-active treatment for three years. Neither~     patients or investigators will be aware of the treatment received. After three years of~     treatment all patients will receive Pulmicort for 2 further years.~   "
222840|NCT00641901|"~     Compelling evidence suggesting a possible link between maternal pregnancy-related~     periodontitis (gum disease) and spontaneous pre-term birth (PTB)makes effective management of~     oral health a relevant and significant obstetrical-dental issue.~      The purpose of this pilot study is to determine whether intensive education and counseling~     can help pregnant women learn to maintain excellent oral health and in doing so reduce the~     severity of gingivitis and periodontitis during their pregnancy. Failure to effectively~     remove the plaque biofilm from the surface of teeth every day is the crucial event leading to~     the development of gingivitis and plaque-induced gingivitis is the most common form of~     periodontal disease in pregnant women.~      We therefore hypothesize that patients can be taught to effectively modulate their own~     disease through intensive education and meticulous home care coupled with closely monitored~     behavior modification.~      We believe this may be an effective approach toward improving oral health with the potential~     to reduce adverse pregnancy outcomes.~   "
222841|NCT00641888|"~     Cardiovascular risk appears to be linked to some degree with inflammation. HIV medications~     have been linked with cardiovascular risk. In this study we will be measuring levels of~     chemicals in the body associated with inflammation before and after starting HIV medications~     in patients with HIV. We hope to understand what happens to these chemicals once a patient~     with HIV is started on these medications to understand their role in cardiovascular risk.~   "
222842|NCT00641875|"~     Arterial stiffness refers to the accumulation of extracellular deposits of matrix and calcium~     which reduce blood vessel compliance. Although there is growing evidence that increased~     arterial stiffness is associated with chronic kidney disease (CKD), its pathogenesis is~     unclear. Pulse wave velocity (PWV) and augmentation index (AIx) provide tools for estimating~     arterial stiffness, and therefore predicting cardiovascular morbidity and mortality. The aims~     of the study are: (1) compare the effects of nocturnal and conventional haemodialysis on~     arterial stiffness, and (2) examine the relationship between arterial stiffness and clinical~     and biochemical parameters.~   "
222843|NCT00641862|"~     This study is a randomized, double-blind trial among 300 pregnant Indian women in order to~     determine the effectiveness of vitamin B12 supplementation in improving maternal B12 status.~     Secondary aims for this trial include maternal hemoglobin, maternal weight gain during~     pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care,~     including routine supplementation with iron and folate.~   "
242034|NCT00386490|"~     To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of~     larazotide acetate.~   "
222844|NCT00641849|"~     This research will focus on the effect of a 6-month behavioral intervention delivered via the~     World Wide Web that is aimed at increasing physical activity levels and decreasing dietary~     fat intake in a general population of adults. The study will be randomized and blinded. We~     are also planning to study subjects' compliance and retention rates when enrolled in a~     completely on-line study.~   "
222845|NCT00641836|"~     Recent researches indicate that impairment of vascular and endothelial homeostasis plays a~     major role in the initiation and development of IPAH.We have recently reported the safety and~     feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients~     with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for~     therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such~     therapy. To help answer these questions, we designed the one year follow-up to investigate~     the safety and efficacy of autologous EPCs injection in patients with IPAH.~   "
222846|NCT00641823|"~     The proposed project will address the measurement and ramifications of out-of-home mobility~     problems in various orthopedic disorders in an innovative way, using advanced tracking~     technologies.~   "
222847|NCT00641810|"~     Snoring is a problem for many people, often disturbing energy level, quality of sleep, and~     the relationship with a bed partner. Two observational studies that have indicated a~     relationship between the consumption of caffeine and snoring. The objective of this study~     will be to observe the degree of snoring and quality of sleep when caffeine intake is reduced~     over a period of four weeks. This will be a prospective, before-and-after study of a~     behavioral intervention.~      This study will engage thirty adults who report snoring, drink two cups of coffee or more per~     day (or an equivalent amount of caffeine), and have a consistent bed partner who can report~     on snoring severity. Both subject and partner will be asked to fill out a diary each day. The~     subjects will record the type of caffeine consumed, time at which each beverage was ingested,~     the total minutes of physical exercise, any caffeine withdrawal symptoms, quality of sleep,~     and energy in the morning. The partner (reporter) will rate his or her own sleep quality and~     energy in the morning, as well as the snoring level of the subject. Beginning the second week~     of the study, the subject will reduce caffeine intake to half the baseline consumption, and~     on the third week, will eliminate caffeine altogether.~      At the end of each week, the participants will be asked to mail their diaries in to the~     researchers and start a new series of entries. The study team will also call each week to~     answer any questions or concerns of the subject and reporter, and encourage continued~     reporting. When six weeks have elapsed following the completion of the last diary, the~     investigators will make a final call to the participants to record their current level of~     snoring, quality of sleep, and daily energy level.~   "
222848|NCT00641797|"~     Benign Paroxysmal Positional Vertigo (BPPV) is a common complaint of emergency department~     patients. The importance of early diagnosis and treatment can lead to a much improved quality~     of life for patients afflicted by this ailment. It is the purpose of this study to evaluate~     and examine two methods of treatment. Patients will be randomized to receive the more common~     conventional medication therapy versus the canalith repositioning technique. All patients~     enrolled into this study are emergency department patients who have been diagnosed with BPPV~     via a positive Dix-Hallpike Maneuver. The hypothesis of this study is that vestibular~     rehabilitation will allow for resolution of symptoms without the use of conventional~     medication therapy in the acute management of BPPV in the emergency department patient.~   "
222849|NCT00641784|"~     In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine~     versus intravenous magnesium sulfate in the acute management of preterm labor in terms of~     defined early and late neonatal measures~   "
222850|NCT00641771|"~     To compare change in fractional calcium absorption following administration of MK0217A~     relative to matching placebo, in postmenopausal women with osteoporosis~   "
222851|NCT00641758|"~     Pycnogenol® is a proprietary bark extract of the French maritime pine tree (Pinus pinaster~     ssp. atlantica). Pycnogenol® has prevented pathologic symptoms such as chronic inflammation~     and increased platelet aggregation, a risk factor for cardiovascular diseases. The~     endothelium is increasingly recognized not only a target (with vascular remodelling occurring~     in response to an injury and resulting in atherosclerosis), but also a mediator in the~     pathogenesis of atherosclerosis. Indeed, endothelial cells play an important regulatory role~     in the cardiovascular system by the expression of numerous molecules and release of mediators~     such as nitric oxide (NO), superoxide and endothelin-1 (ET-1). Data from animal studies, as~     well as human studies indicate that Pycnogenol may improve endothelial function, which is a~     powerful surrogate for clinical prognosis.~   "
222852|NCT00641745|"~     Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This~     clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long~     term among clinically stable patients. The study will also assess the long term effectiveness~     of lurasidone as compared to an active comparator.~   "
222853|NCT00641732|"~     The purpose of this study is to determine if TAK-442, once daily (QD) or twice daily (BID),~     is as safe and effective as enoxaparin in preventing the development of blood clots after~     knee replacement surgery.~   "
222854|NCT00641719|"~     The purpose of the study is to investigate safety and efficacy of duloxetine for patients~     with painful diabetic neuropathy at long-term use.~   "
222855|NCT00641706|"~     This phase II trial is studying how well giving vorinostat together with bortezomib works in~     treating patients with progressive, recurrent glioblastoma multiforme. Vorinostat and~     bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving vorinostat together with bortezomib may kill more tumor cells.~   "
222856|NCT00641693|"~     The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5~     years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and~     stuffy noses.~   "
222857|NCT00641680|"~     The purpose of this study is to compare once daily treatment with Rhinocort against placebo~     and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.~   "
222858|NCT00641667|"~     The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day~     transdermal patch (patch containing a drug that is put on the skin so the drug will enter the~     body through the skin) in participants switched from morphine preparations, oral oxycodone~     preparations, fentanyl citrate injection or fentanyl patch for cancer pain.~   "
222859|NCT00641654|"~     To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy~     with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC)~     virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA <50 IU/mL at the end~     of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior~     treatment) previous therapy with pegylated interferon and ribavirin given for at least 12~     weeks and at most 24 weeks.~   "
222860|NCT00641641|"~     The purpose of this study is to measure the decay characteristics of HIV in the blood of~     patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV~     drug, an integrase inhibitor. This study explores how this new combination of therapy reduces~     virus in various compartments of the body and immune system.~   "
222861|NCT00641628|"~     96 patients were offered a nipple sparing mastectomy.~   "
222862|NCT00641615|"~     The purpose of this study is to evaluate the safety and immune response of different doses of~     RNF43-721 emulsified with Montanide ISA 51 in combination with S-1/CPT-11 chemotherapy.~   "
222863|NCT00641602|"~     This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated~     with either esomeprazole or lansoprazole~   "
222864|NCT00641589|"~     The primary objective of this study is to describe how four different dosing regimens of~     PROCRIT (epoetin alfa) are utilized in patients with anemia due to non-dialysis chronic~     kidney disease (CKD).~   "
222865|NCT00641576|"~     Dental implants are small metal posts that look like miniature screws. They are surgically~     implanted into the jawbone where they serve as substitute tooth roots. Implants are used in~     dentistry to reestablish function and aesthetics to areas of the mouth were natural teeth are~     missing.~      Classical dental implants are made in two pieces. One part anchors in the jawbone and one~     part serves as a connecting post (an abutment) that attaches to a crown restoration or to~     attachment clasps that hold a denture in place.~      Occasionally the materials used to fasten the two implant components together work their way~     loose and over time the abutment may begin to disconnect. If this happens a small gap appears~     between the implant and abutment. There are many reasons why this loosening occurs. One~     reason may be the design of the implant itself and another may be the way the two components~     are fastened together.~      This study will assess the performance of an implant with a new design. The investigators~     hypothesize that using this implant design will reduce the risk of an implant-abutment~     disconnect and improve long-term success of implant therapy.~   "
222866|NCT00641563|"~     Sedation may be necessary in intensive care to facilitate diverse therapeutic interventions,~     but the use of sedative drugs may increase the risk of delirium and long-term cognitive~     impairment. Thus the implementation and monitoring of sedation remains difficult despite the~     use of sedation protocols and clinical sedation scores. Attempts to improve sedation~     monitoring through the use of the electroencephalogram(EEG) have been disappointing. Derived~     variables based on the unstimulated EEG fail to predict the response to external stimuli at~     the clinically most relevant light-to-moderate sedation levels, and the overlap between~     moderate and deep sedation levels is wide. We have demonstrated that long-latency auditory~     evoked potentials (ERPs)can be used to avoid deep levels of sedation in healthy volunteers~     during propofol sedation, independent of the concomitant administration of remifentanil. This~     approach has a potential clinical application for improved monitoring of sedation. Since the~     effects of different sedative drugs on the EEG may vary widely, the use of ERPs to monitor~     sedation needs to be evaluated with different sedative drugs. Therefore we will administer~     two widely used drug combinations (dexmedetomidine/remifentanil and midazolam/remifentanil)~     in healthy volunteers and record ERPS and processed EEG during clinical relevant sedation~     levels~   "
222867|NCT00641550|"~     The effects of physical exercise on pregnancy remain to be elucidated. A randomized~     controlled trial will be conducted to study the impact of exercise on maternal and perinatal~     outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and~     improves birthweight when started early in pregnancy, with no impact on pregnancy duration,~     Apgar scores and neonatal complications.~   "
222868|NCT00641537|"~     The purpose of this extension trial is to further evaluate the safety and tolerability of~     oral cladribine in subjects who have previously completed treatment within Trial 25643~     (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week~     treatment.~   "
222869|NCT00641524|"~     The purpose of this study is to evaluate the use of phlebotomy (blood taking)as a treatment~     for patients with non-alcoholic fatty liver disease.~   "
222870|NCT00641511|"~     Assess the effect of nepicastat in the treatment of in Post Traumatic Stress Disorder (PTSD)~     in conflict or combat zone experienced veterans, in comparison to placebo.~   "
222871|NCT00641498|"~     Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our~     objective is to evaluate the addition of the resources of an suicide prevention centre to~     standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt~     patients in 2 Emergency departments (multicenter study) were included after standard~     psychiatric treatment and referral. After Written informed consent, psychological assessment~     (depression, suicide intention) was carried out After randomisation, control patients were~     given an information card describing the Suicide Prevention Center (SPC); experimental~     patients had a first meeting with a psychologist of the SPC.~      To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an~     evaluation of these behaviors was carried out every month during a two year follow-up.~   "
222872|NCT00641472|"~     A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given~     once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the~     evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children~     aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will~     receive 5mg strength SINGULAR.~   "
222873|NCT00641459|"~     The purpose of this observational study is to obtain the current status of patients with~     Behavioral and Psychological Symptoms of Dementia. This study is also expected to further~     provide insight into the evolution of behavioral and psychotic symptoms and its relationship~     with treatment as well as severity of cognitive declines in a naturalistic setting.~   "
222874|NCT00641446|"~     A study to determine whether treatment with Pulmicort in children has any effect on the~     varicella vaccine~   "
222875|NCT00641433|"~     This study's purpose is to prospectively determine whether topical therapy with an oxidized~     regenerated cellulose collagen-silver compound is more effective than the current standard of~     topical antibiotic therapy for care following the removal of an ingrown toenail. Eighty adult~     patients with ingrown toenails will be recruited. Each patient will randomly be assigned to~     apply either topical silver sulfadiazine cream (standard antibiotic) or the novel~     collagen-silver compound to their nail bed daily, following removal of the ingrown portion of~     nail. Patients will return for follow up visits weekly, until healing has occurred or twelve~     weeks have passed. Healing will be defined as resolution of drainage and inflammatory changes~     surrounding the nail border.~   "
222876|NCT00641420|"~     Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair~     skinned individuals. This study aims to test the efficacy and safety in darker skin types.~     Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five~     treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%,~     50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.~   "
222877|NCT00641407|"~     The maintenance of nearly normal glycemic levels reduces the risk of diabetic complications,~     but is difficult to achieve, despite the administration of escalating doses of oral~     antidiabetic drugs, such as metformin, sulfonylureas, and thiazolidinediones. Most patients~     eventually require insulin which usually is added when glycemic control with a regimen of~     oral antidiabetic agents becomes suboptimal.~      The aims of the present study were: 1) To compare the clinical efficacy of insulin glargine~     and neutral protamine lispro (NPL) insulin when added to ongoing oral therapy in poorly~     controlled type 2 diabetic patients; 2) to find out the possibility to phenotype the patient~     who may benefit more by the single treatment.~      This an open-label, randomized, parallel, 36-week comparative study was performed between~     January 2007 and March 2008 at a single centre.~   "
222878|NCT00641394|"~     The purpose of this study is to determine whether there is a change in levels of cortisol, a~     key stress hormone, during the course of a psychotherapy session. The two forms of~     psychotherapy compared are Cognitive Behavioral Therapy (CBT) and Emotional Freedom~     Techniques (EFT). A no treatment control group provides a baseline measure. The change in~     cortisol level is compared between the start and end of a one hour session.~   "
222879|NCT00641381|"~     RATIONALE: Giving high-dose chemotherapy drugs, such as carmustine, etoposide, and~     cyclophosphamide, before a peripheral blood stem cell transplant stops the growth of cancer~     cells by stopping them from dividing or killing them. After treatment, stem cells that were~     collected from the patient's blood are returned to the patient to replace the blood-forming~     cells that were destroyed by the chemotherapy.~      PURPOSE: This clinical trial is studying the side effects of giving high-dose carmustine,~     etoposide, and cyclophosphamide together with a stem cell transplant and to see how well it~     works in treating patients with HIV-associated lymphoma.~   "
222880|NCT00641368|"~     The study will evaluate the R4Power program, an online intervention designed to teach~     adolescents coping and problem-solving skills.~   "
222881|NCT00641355|"~     Monitoring of different serumproteins after severe trauma and during trauma-induced sepsis.~        -  Trial with surgical intervention~   "
222882|NCT00641342|"~     Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around~     the stoma. In some cases these problems result in the need of surgical correction and the~     risk of recurrent hernia after operative intervention is regrettably high. Preliminary~     investigations suggest a role for primary mesh placement to prevent parastomal hernia. The~     use of a mesh as a preventive measure is a safe procedure. This study will focus on the~     effect of primary mesh placement (two different operative procedures are used) compared to~     patients without mesh placement.~   "
222883|NCT00641329|"~     The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a~     safe and effective add-on to psychostimulant therapy in children and adolescents with~     attention deficit hyperactivity disorder (ADHD).~   "
222884|NCT00641316|"~     When a tooth is extracted the ridge of bone that held the tooth in place begins to heal and~     over time new bone grows to fill the empty space left by the missing tooth. Sometimes this~     process works very well and new bone grows to completely fill the socket, at other times new~     bone fails to fill in the space completely and patients are left with uneven bone-fill.~      Grafted extraction sockets may fill with bone faster and more evenly than those without~     grafts, allowing the dentist to have greater control over the healing process and to repair~     the area with dental implants in a shorter period of time.~      This study will help determine if grafting an extraction socket, with or without enriching~     the graft material, is an added benefit when compared to allowing the socket to heal~     naturally.~      The study will also assess how well two different dental implant designs used to restore the~     area will function over time.~   "
222885|NCT00641303|"~     RATIONALE: Acupuncture may help relieve muscle and bone pain caused by aromatase inhibitor~     therapy, such as letrozole, exemestane, and anastrozole.~      PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works in~     reducing muscle and bone symptoms in women receiving letrozole, exemestane, or anastrozole~     for stage 0, stage I, stage II, or stage III breast cancer.~   "
222886|NCT00641290|"~     To study the role of Vigileo monitor using the FloTrac sensor to measure cardiac output using~     the pulse contour analysis as well as central venous oxygen saturation monitoring as a guide~     for tissue perfusion. The accuracy of the Vigileo monitoring was compared with the~     conventional thermodilution method for measuring cardiac output using the pulmonary artery~     catheter and mixed venous oxygen saturation for assessing global tissue perfusion.~   "
222887|NCT00641277|"~     Dental implants are used in dentistry to reestablish function and appearance to areas of the~     mouth where natural teeth are missing. Implants can be a good choice for almost all areas of~     the mouth except where the space left by missing teeth is too narrow. This is usually the~     case when front teeth are lost of have been missing since birth.~      The Maximus dental implant is the smallest implant made, just 3mm in diameter, and is~     especially designed to replace missing front teeth and yet be strong enough to function as a~     natural tooth.~      This study will assess the functional success of BioHorizons Maximus one-piece endosseous~     dental implant.~      We hypothesize that placement of the 3mm dental implant in areas of limited tooth-to-tooth~     spacing will be an efficacious tooth root replacement.~   "
222889|NCT00641251|"~     The present study is the first stage of a research program whose ultimate goal is to conduct~     a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2. This~     program will determine the relative effectiveness of RYGB combined with intensive medical~     management (IMM), versus IMM alone, in reducing CVD event rates and mortality in patients~     with poorly controlled diabetes. IMM will include rigorous lifestyle modification for weight~     loss and stepped pharmacologic treatment for diabetes and other CVD risk factors. The~     proposed study is a randomized trial which will provide an assessment of the efficacy of~     treatment, in reducing CVD risk factors and also assessing the feasibility, cost, and safety~     of a larger trial.~   "
222890|NCT00641238|"~     We are collecting clinical notes and results of imaging studies (CT and PET scans) from~     referring physicians who follow the clinical status of patients treated with radiofrequency~     ablation (RFA). The research objective is to determine whether the patients with (RFA) remain~     alive, and whether they are in remission or have progressive/ recurrent malignancy~   "
222891|NCT00641225|"~     The purpose of this study is to determine the safety and tolerability of single doses of~     SBI-087 in subjects with rheumatoid arthritis.~   "
222892|NCT00641212|"~     The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on~     growth in children with perennial allergic rhinitis over 12 months.~   "
222893|NCT00641199|"~     The purpose of this study is to evaluate if ingestion of a probiotic formula (Jarrow-Dophilus~     EPS)reduces incidence of diarrhea and improves the quality of life of patients receiving~     antibiotic therapy.~   "
222894|NCT00641186|"~     This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for~     the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in~     patients with mild to moderate Parkinson's Disease (PD).~   "
222895|NCT00641173|"~     Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom~     (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD).~     Intervening soon after the trauma is critical for long-term outcomes, since with time~     traumatic memories become resistant to treatment. The current study will compare treatment~     with the selective serotonin reuptake inhibitor (SSRI) paroxetine to placebo in returning OIF~     veterans who have returned from Iraq in the past six months, who meet criteria for early~     PTSD. Assessment of PTSD symptoms, brain markers, neuropsychological testing of memory, and~     cortisol response to an Iraq-related traumatic script before and after the intervention are~     proposed to provide information about the effects of the interventions on PTSD symptoms and~     stress-responsive hormonal systems.~   "
222896|NCT00641160|"~     The purpose of this study is to determine the safety of oral administration of vinorelbine~     once daily for at least 7 days. The study will be conducted in subjects with a~     non-hematologic malignancy for which there are no currently accepted therapies.~   "
222897|NCT00641147|"~     This randomized phase II trial studies curcumin in treating patients with familial~     adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of~     rectal polyps or colorectal neoplasia.~   "
222898|NCT00641134|"~     The goal of this trial is to assess the medium- (6 months) and long-term (12 months) effects~     of a Home-Based exercise program after in-Hospital comprehensive Cardiac Rehabilitation (CR)~     - as compared with usual care - on exercise capacity, health-related quality of life and~     health care services utilization, in patients (pts) older than 75 years after recent acute~     coronary syndromes or cardiac surgery.~   "
222899|NCT00641121|"~     Unexplained fever in children with cancer is a common occurrence, often requiring hospital~     admission for evaluation and treatment with intravenous antibiotics. While empiric use of~     intravenous antibiotics is the norm in this population, between 48-70% of febrile and~     neutropenic episodes remain without an identifiable source. An understudied area is the~     potential role of betaherpesvirus infections in such febrile episodes. These viruses are~     significant pathogens in patients who become immunocompromised in conjunction with organ~     transplantation or acquired immune deficiency syndrome (AIDS). It is possible that they are~     similarly pathogenic in children who become immunocompromised due to cancer chemotherapy.~      Thus, we will investigate the association between the betaherpesviruses and fever in children~     with cancer. The betaherpesviruses include cytomegalovirus (CMV), human herpesvirus 6A~     (HHV-6A), human herpesvirus 6B (HHV-6B), and human herpesvirus 7 (HHV-7). These viruses are~     grouped based on shared biological and genetic properties. Each is commonly acquired in~     childhood, persists in the human host, and can reactivate. Reactivation occurs intermittently~     throughout life in healthy individuals and is seldom associated with disease. Immune~     suppression is associated with a higher likelihood of reactivation and clinical disease.~     Latency of these viruses involves highly regulated processes that result in the viruses~     evading destruction and persisting within the host. Should balance be disrupted, as with~     cancer and anticancer therapy altering the normal host state, the environment may become~     favorable for betaherpesvirus reactivation, leading to disease and further alterations of the~     immune system.~   "
222900|NCT00641108|"~     This study will examine changes in brain serotonin activity in people with depression before~     and after they receive cognitive behavioral therapy.~   "
222901|NCT00641095|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. It is not yet known~     whether giving combination chemotherapy together with rituximab is more effective than~     combination chemotherapy alone in treating mantle cell lymphoma.~      PURPOSE: This randomized phase III trial is comparing how well fludarabine and~     cyclophosphamide work when given together with or without rituximab in treating patients with~     previously untreated mantle cell lymphoma.~   "
222902|NCT00641082|"~     A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The~     purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine~     and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.~   "
222903|NCT00641069|"~     To evaluate the effect of use of automated chest compression device on blood pressure in~     patients presenting with cardiac arrest. Higher systolic, diastolic and mean blood pressures~     are expected.~   "
222904|NCT00641056|"~     The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and~     insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen~     et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and~     tolerability.~   "
222905|NCT00641043|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial~     combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with~     insufficient glycaemic control.~   "
222906|NCT00641030|"~     RATIONALE: Giving chemotherapy, such as clofarabine and melphalan, before a donor stem cell~     transplant helps stop the growth of cancer or abnormal cells. It also helps stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient, they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving cyclosporine~     and mycophenolate mofetil after the transplant may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when~     given together with high-dose melphalan followed by a donor stem cell transplant in treating~     patients with acute myeloid leukemia, acute lymphocytic leukemia, or myelodysplastic~     syndromes.~   "
222907|NCT00641017|"~     Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections~     in children, the elderly, and those with compromised immune systems. HPIV1 is also the~     leading cause of viral croup in children under 6 years old. The purpose of this study is to~     determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2~     groups of adults and then in children who have been previously exposed to HPIV1. Once the~     safety of this vaccine has been established in these groups, an additional 2 groups of~     infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve~     infants and children are the most vulnerable to naturally circulating HPIV1 and are the~     target population of this vaccine.~   "
222908|NCT00641004|"~     Primary objective: To determine the levels of malondialdehyde (MDA) and immunohistochemistry~     surrogate of inflammation in patients with NSAID-induced gastric mucosal injury treated with~     Rebamipide 3x a day vs Esomeprazole 40mg once a day. Secondary objective: For patients who~     become symptomatic during NSAID treatment, to compare the proportion of patients with~     positive treatment effects using the Likert scale. Third objective: To compare the proportion~     of patients with positive treatment effects as determined by Modified Lanza scoring between~     the two groups.~   "
222909|NCT00640991|"~     Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial~     infarction and admission hyperglycemia.~   "
222910|NCT00640978|"~     The goal of this clinical research study is to learn if the combination of RAD001 and~     erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this~     drug combination will also be studied.~      Primary Objectives:~      -Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001~     in patients who have received previous treatment for advanced pancreatic cancer.~      Secondary Objectives:~        -  Determine the progression-free survival (PFS).~        -  Determine the response rate (RR).~   "
222911|NCT00640965|"~     The study will evaluate if DP-VPA, a derivative of valproate (a drug that is commonly used~     for the prevention of migraine attacks), can reduce the rate of migraine attacks.~      Migraine patients will take DP-VPA or placebo (an inactive look-alike drug) every morning and~     will have to report any migraine attacks they have during the study's 18-week follow up.~   "
222912|NCT00640952|"~     The purpose of this study is to determine how many patients with Parkinson's disease have~     compulsive behaviors, and what types of behaviors they have. This study will also determine~     if acamprosate can be used to treat compulsive behaviors in Parkinson's disease patients.~   "
222913|NCT00640939|"~     The primary purpose of this study is to assess the effectiveness of once daily application of~     a diclofenac sodium patch to the skin near or over the painful area. In this study, the~     location being studied will be one of the following: the affected shoulder, elbow, or wrist.~      The secondary purpose of this study is to assess the safety and tolerability of the~     diclofenac patch on the subject's skin, in the location being studied.~   "
222914|NCT00640926|"~     The purpose of this study is to determine whether RX-1741, an oxazolidinone antibiotic, is~     safe and effective in the treatment of mild to moderate community acquired pneumonia (CAP).~   "
222915|NCT00640913|"~     In this trial will be investigated if a defunctioning loop stoma used in low anterior~     resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which~     is present clinical practise.~   "
222916|NCT00640900|"~     This study will provide data on the response over 24 months to two commercial weight loss~     programs (center-based and telephone-based) compared to control conditions.~   "
222917|NCT00640887|"~     The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin~     (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an~     alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic~     induction effect appears to be less important on the associated antiretroviral therapy (ART)~     drugs.~      This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in~     combination with different ART regimens in Vietnamese HIV infected patients with pulmonary~     tuberculosis, in order to define optimal doses that will be further tested in a larger phase~     III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.~   "
222918|NCT00640874|"~     This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as~     short-term prophylaxis against pandemic influenza infection in people who have close familial~     contact with the disease. The study is observational only. The primary measure used in this~     study will be the incidence of symptomatic pandemic influenza in patients receiving~     prophylaxis. Seroconversion to pandemic influenza, the incidence of adverse events and the~     relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. This~     project will commence upon pandemic influenza being declared in Australia, Hong Kong or~     Singapore. Data will be analysed as quickly as possible to help inform the continued use of~     neuraminidase inhibitor therapy as a cornerstone of the public health agency response to~     pandemic influenza.~   "
222919|NCT00640861|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. It is not yet known which vaccine is most effective in treating breast~     cancer.~      PURPOSE: This randomized clinical trial is studying the side effects of three different~     vaccine therapies and comparing the vaccines to see how well they work in treating patients~     with previously treated stage II or stage III breast cancer.~   "
222920|NCT00640848|"~     The aim of the study is to determine the minimum effective dose of ACT-078573 on sleep~     efficiency and to assess the effects of different doses of ACT-078573 on other PSG~     parameters.~   "
222921|NCT00640835|"~     This study will evaluate the safety and tolerability on the oral mucosa of~     buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12~     weeks in opioid dependent individuals who are already on a stable regimen of~     buprenorphine/naloxone.~   "
222922|NCT00640822|"~     There are few therapies suitable for the treatment of psoriasis on the face and skin folds.~     As these areas are sensitive, irritation and other adverse reactions are more common than~     elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once~     daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus~     hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in~     patients with psoriasis vulgaris on the face and on the intertriginous ares~   "
222923|NCT00640809|"~     To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen~     plus omeprazole~   "
222924|NCT00640796|"~     Modern frontline therapy for patients with hematologic malignancies is based on intensive~     administration of multiple drugs. In patients with relapsed disease, response to the same~     drugs is generally poor, and dosages cannot be further increased without unacceptable~     toxicities. For most patients, particularly those who relapse while still receiving frontline~     therapy, the only therapeutic option is hematopoietic stem cell transplantation (SCT). For~     those who relapse after transplant, or who are not eligible for transplant because of~     persistent disease, there is no proven curative therapy.~      There is mounting evidence that NK cells have powerful anti-leukemia activity. In patients~     undergoing allogeneic SCT, several studies have demonstrated NK-mediated anti-leukemic~     activity. NK cell infusions in patients with primary refractory or multiple-relapsed leukemia~     have been shown to be well tolerated and void of graft-versus-host disease (GVHD) effects.~     Myeloid leukemias are particularly sensitive to NK cells cytotoxicity, while B-lineage acute~     lymphoblastic leukemia (ALL) cells are often NK-resistant. We have developed a novel method~     to expand NK cells and enhance their cytotoxicity. Expanded and activated donor NK cells have~     shown powerful anti-leukemic activity against acute myeloid leukemia (AML) cells and~     T-lineage ALL cells in vitro and in animal models of leukemia.~      The present study represents the translation of these laboratory findings into clinical~     application.We propose to determine the safety of infusing expanded NK cells in pediatric~     patients who have chemotherapy refractory or relapse hematologic malignancies including AML,~     T-lineage ALL, T-cell lymphoblastic lymphoma (T-LL), chronic myelogenous leukemia (CML),~     juvenile myelomonocytic leukemia (JMML),myelodysplastic syndrome (MDS), Ewing sarcoma family~     of tumors (ESFT) and rhabdomyosarcoma (RMS). The NK cells used for this study will be~     obtained from the patient's family member who will be a partial match to the patient's immune~     type (HLA type).~   "
222925|NCT00640783|"~     The metabolic syndrome has been identified as a target for dietary therapies to reduce risk~     of cardiovascular disease; however, the role of diet in the etiology of the metabolic~     syndrome is poorly understood. To assess the effect of a Mediterranean-style diet on~     endothelial function and vascular inflammatory markers in patients with the metabolic~     syndrome~      Randomized, single-blind trial conducted from June 2001 to January 2004 at a university~     hospital in Italy among 180 patients (99 men and 81 women) with the metabolic syndrome, as~     defined by the Adult Treatment Panel III.~      Patients in the intervention group (n = 90) were instructed to follow a Mediterranean-style~     diet and received detailed advice about how to increase daily consumption of whole grains,~     fruits, vegetables, nuts, and olive oil; patients in the control group (n = 90) followed a~     prudent diet (carbohydrates, 50%-60%; proteins, 15%-20%; total fat, <30%).~      After 2 years, patients following the Mediterranean-style diet consumed more foods rich in~     monounsaturated fat, polyunsaturated fat, and fiber and had a lower ratio of omega-6 to~     omega-3 fatty acids. Total fruit, vegetable, and nuts intake (274 g/d), whole grain intake~     (103 g/d), and olive oil consumption (8 g/d) were also significantly higher in the~     intervention group (P<.001). The level of physical activity increased in both groups by~     approximately 60%, without difference between groups. Mean body weight decreased more in~     patients in the intervention group (-4.0 kg) than in those in the control group (-1.2 kg)~     (P<.001). Compared with patients consuming the control diet, patients consuming the~     intervention diet had significantly reduced serum concentrations of hs-CRP (P = .01), IL-6 (P~     = .04), IL-7 (P = 0.4), and IL-18 (P = 0.3), as well as decreased insulin resistance~     (P<.001). Endothelial function score improved in the intervention group but remained stable~     in the control group. At 2 years of follow-up, 40 patients in the intervention group still~     had features of the metabolic syndrome, compared with 78 patients in the control group~     (P<.001).~      A Mediterranean-style diet might be effective in reducing the prevalence of the metabolic~     syndrome and its associated cardiovascular risk.~   "
222926|NCT00640770|"~     The primary objective of this study is to compare the performance of the CYPHER SELECTTM +~     Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon~     angioplasty in de novo and restenotic native below the knee tibioperoneal, anterior and/or~     posterior tibial and/or peroneal arterial lesions in a prospective, multicenter, randomized~     clinical study.~   "
222927|NCT00640757|"~     The purpose of this study is to determine if limiting dietary methionine (MET), one of the 10~     essential amino acids (which make up proteins), causes weight loss and/or improves glucose~     metabolism.~   "
222928|NCT00640744|"~     Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting~     of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and~     tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. One way of~     treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. Statins~     have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by~     11-30%.The purpose of this study is to determine if short term treatment with atorvastatin~     causes early favorable changes in the plaques that block blood flow through the carotid~     arteries. These changes can be assessed 1) by taking pictures of the carotid arteries with~     MRI and Ultrasound before and after statin treatment, and 2) by special studies of the~     plaques removed from the carotid arteries by surgery.~   "
222929|NCT00640731|"~     This is a prospective, multi-center single arm registry to assess the use of the OmniWave~     Endovascular System in subjects presenting with either lower or upper extremity acute~     (symptoms have been present for greater than or equal to 14 days) DVT.~   "
222930|NCT00640718|"~     The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to~     assist hospitals to better address and improve recognition and response to changes in a~     patient's condition.~      The system, monitors the patient while in bed consists of a contact-free sensor that is~     placed under the bed mattress and identifies respiratory and heart rates, degree of patient's~     movement or agitation while in bed as well as patient's actual exit out of the bed. The~     EverOn system does not require a physical contact with the patient, eliminating the need for~     any direct contact electrodes, leads, cuffs or nasal cannulae.~   "
222931|NCT00640705|"~     The primary purpose of this study is to assess the effectiveness of once daily application of~     a diclofenac sodium patch to the skin near or over the painful area. In this study, the~     location being studied will be either the left or right ankle.~      The secondary purpose of this study is to assess the safety and tolerability of a diclofenac~     patch on the skin.~   "
222932|NCT00640692|"~     The purpose of this study is to determine the genetic makeup of gastro intestinal stomach~     tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be~     screened for mutations and this information will be used to determine whether the~     progression-free survival of patients being treated with the cancer medication sunitinib is~     related to the underlying genotype of their GIST.~   "
222933|NCT00640679|"~     The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with~     a superior clinical outcome compared with abrupt cessation (superiority hypothesis).~   "
222934|NCT00640666|"~     It is important to confirm health benefits experienced by breast cancer survivors after~     participation in a physical activity behavior change intervention. One such potential benefit~     is a reduction in harmful inflammation that might lead to increased symptoms or cancer risk.~     Because little is known about how physical activity behavior change interventions influence~     inflammation in breast cancer survivors, the investigators study will measure inflammation~     with blood markers known as cytokines among breast cancer survivors before and after a~     physical activity intervention. Such information has the potential to lead to improved~     physical functioning, reduction in bothersome symptoms (e.g., fatigue), and reduced cancer~     risk in breast cancer survivors.~   "
222935|NCT00640653|"~     This study will develop and evaluate the effectiveness of culturally appropriate HIV/sexually~     transmitted disease risk-reduction interventions in reducing sexual risk behavior among young~     African-American adolescents.~   "
222936|NCT00640640|"~     One concern about repeated intravitreal injections of bevacizumab (Avastin) and ranibizumab~     (Lucentis) in wet age related macular degeneration, is that in addition to blocking the~     proteins that triggers the development and proliferation of abnormal vessels in the center of~     the retina, they may also result in changes in the normal vessels that feeds the outer part~     of the retina.~      Small vessels with fenestrations (such as those that feed the outer part of the retina, which~     are called choriocapillaris) appear to be especially sensitive to this protein (called~     vascular endothelial growth factor, VEGF) withdrawal.~      It is estimated that global blood flow in the vascular layer under the retina (called~     choroid) may be indirectly assessed by measuring the amplitude of the ocular pulsation (the~     pressure inside the eye change according to the cardiac cycle, similar to the change in blood~     pressure) which is called Ocular Pulse Amplitude (OPA). The Pascal Dynamic Contour Tonometer~     (Pascal DCT) is a new tonometer (a device which measures the pressure within the eye)~     designed to measure intraocular pressure and ocular pulse amplitude.~      No published study has yet assessed the effect of bevacizumab (Avastin) or ranibizumab~     (Lucentis) treatment for wet AMD (or on any other retinal disease) on OPA. This is our aim in~     this pilot study, in which we will measure the pressure within the eye just prior to~     bevacizumab/Ranibizumab treatment, followed by repeated measurements a week and a month after~     the treatment.~      For this purpose, up to 60 patients with wet AMD will be recruited.~   "
222937|NCT00640627|"~     To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients~     with knee osteoarthritis who were unresponsive to treatment with prescription strength~     naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen~   "
222938|NCT00640614|"~     We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic~     performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate,~     Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse~     blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients~     with suspected contact dermatitis, and in adult patients with a known or suspected~     sensitization to at least one of the seven allergens.~   "
222939|NCT00640601|"~     A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and~     Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects with~     Schizophrenia.~   "
222940|NCT00640588|"~     This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment~     with telbivudine~   "
222941|NCT00640575|"~     Corticosteroid injections is a popular treatment option in shoulder disease. The evidence of~     effectiveness of corticosteroid injections is however contradicting. The importance of the~     accuracy of the steroid placement have been discussed and recently there are a few studies~     indicating better treatment effect if the injections are guided towards specific anatomical~     structures by real time ultrasound imaging. None of these studies have been double blinded.~     The aim of this study is to investigate the importance of placement of steroid injection in~     patients with rotator cuff disease by comparing systemic and ultrasound-guided injection in~     the subacromial bursa using a double blinded design.~   "
222942|NCT00640562|"~     Aim of the study is to assess if the new compound Seroquel XR™ is non-inferior to~     Risperidone, considered as the reference drug for the treatment of depressive symptoms of~     schizophrenia.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
222943|NCT00640549|"~     The study will investigate the effects of atorvastatin on the concentrations of small, dense~     LDL and HDL subfractions in patients with diabetes and the underlying mechanisms of these~     effects.~   "
222944|NCT00640536|"~     The purpose of this study is to determine the structural and functional cardiac alterations~     in obstructive sleep apne (OSA) independent from systemic and pulmonary arterial hypertension~     and their correlation to the severity of OSA.~   "
222945|NCT00640523|"~     To evaluate the effectiveness and safety of forodesine in CLL patients~   "
222946|NCT00640510|"~     The primary objectives of the study is to confirm if the efficacy of IM olanzapine in~     patients with schizophrenia is greater than IM placebo by comparing changes from baseline to~     2 hours post first IM injection of agitation.~   "
222947|NCT00640497|"~     In this study, a combination of two T-cell directed antibodies both conjugated to a~     cell-killing toxin will be evaluated. Previous in vitro studies have demonstrated that this~     so-called immunotoxin-combination (IT-combination) acts synergistically in eliminating T~     cells. In a subsequent clinical pilot-study, the IT-combination has generated encouraging~     results when applied as third line therapy. Extensive biological and clinical responses could~     be noted in the absence of severe acute toxicities. Building on this experience, the current~     study aims at evaluating the characteristics of the IT-combination when administered in an~     earlier phase of the disease, i.e. as second line instead of as third line therapy.~   "
222949|NCT00640471|"~     RATIONALE: Brivanib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. It is not yet known whether giving brivanib together with cetuximab is more~     effective than cetuximab alone in treating patients with metastatic colorectal cancer.~      PURPOSE: This randomized phase III trial is studying cetuximab to see how well it works~     compared with cetuximab given together with brivanib in treating patients with metastatic~     colorectal cancer.~   "
222950|NCT00640458|"~     The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral~     engorgement in pre-menopausal women, as well as examining the safety and toleration of the~     drug.~   "
222951|NCT00640445|"~     Veterans returning from combat deployments face the interrelated challenges of processing~     their combat experiences and transitioning back to civilian life. Unfortunately, many~     veterans wait years or decades before seeking help for post-deployment problems, if they seek~     it at all. This study seeks to determine whether Internet-Based Expressive Writing (IB-EW), a~     brief, low-cost, easily disseminated, and resource-efficient intervention, can reduce~     psychological symptoms and improve functioning among Operation Iraqi Freedom (OIF) and~     Operation Enduring Freedom (OEF) veterans as they navigate this transition, while also~     attempting to reduce barriers to help-seeking. Expressive Writing, a highly private, readily~     accessible, and non-stigmatizing intervention, has a strong evidence-base in civilian~     populations, but its efficacy in combat veterans has not been tested. This study therefore~     seeks to test the efficacy of Expressive Writing in a veteran population while further~     enhancing its accessibility by delivering it over the internet (Internet-Based Expressive~     Writing; IB-EW). This study will comprise a randomized controlled trial with three~     conditions: (a) Internet-Based Expressive Writing, (b) Internet-Based Control Writing, and~     (c) No Writing/Treatment As Usual, with a total of 1152 OIF/OEF veterans randomized across~     these groups. Expressive Writing participants will write with feeling about their transition~     from being a soldier to being a civilian; Control Writing participants will write factually~     about the information needs of new veterans; and Treatment as Usual participants will~     complete the assessments but not engage in any writing assignments. Participants will~     complete standardized self-report measures of psychological symptoms, psychosocial~     functioning, and life satisfaction at baseline (Session 1) and at three months (Session 6)~     and six months (Session 7) post-intervention. Participants in writing conditions will write~     for 20 minutes on four consecutive days (Sessions 2-5) following completion of baseline~     measures (participants in the TAU condition will not complete Sessions 2-5). The study will~     also attempt to identify individual difference characteristics related to the efficacy of the~     treatment, to see who may be most likely to benefit from the treatment. Analyses will~     primarily entail multivariate analyses of variance. Power is adequate to detect even a small~     effect.~   "
222952|NCT00640432|"~     To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with~     acute low back pain~   "
222953|NCT00640419|"~     The purpose of this study is to test if the investigational medication ABT-089 is a safe and~     effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD).~   "
222954|NCT00640406|"~     The clinical investigation is a prospective, international, multi-centre, randomized (1:1)~     trial with follow ups at 2, 6, 12 months and 3 years.~      The purpose of the study is to evaluate the clinical impact of percutaneous transluminal~     renal artery stenting (PTRAS) on the impaired renal function measured by the estimated~     Glomerular Filtration Rate (eGFR) in patients with hemodynamically significant~     atherosclerotic renal artery stenosis (ARAS).~   "
222955|NCT00640393|"~     This study will provide data on the addition of narrow band ultra violet B (nbUVB)~     phototherapy to participants who have not shown an excellent response to three months of~     etanercept.~   "
222956|NCT00640380|"~     Cervical paravertebral blocks (CPVBs) target the brachial plexus from a puncture site~     situated in the posterior aspect of the neck and represent an alternative to interscalene~     blocks (ISBs) for shoulder and proximal humeral surgery. Randomized controlled trials~     comparing CPVB and ISB have found no significant differences in success rate, onset and~     offset times. Because of the reliability of their cutaneous landmarks, CPVBs have become part~     of the investigators' standard practice. With this approach, the brachial approach can be~     identified either with loss of resistance to air (LOR) or nerve stimulation (NS). While some~     authors have used only LOR and reported good success rates, others have hypothesized that NS~     may increase the reliability of the block. In the proposed study, for the first time, the 2~     methods will be formally compared.~   "
222957|NCT00640367|"~     SYNTHESIS is a pragmatic multicenter randomized controlled trial (RCT), open-label, with~     blinded follow-up aiming to determine whether loco-regional intra-arterial (IA) with~     recombinant tissue-plasminogen activator (rt-PA) and/or mechanical devices, as compared with~     systemic intravenous (I.V.) infusion of rt-PA within 3 hours of ischemic stroke, increases~     the proportion of independent survivors at 3 months.~   "
222958|NCT00640354|"~     Automated external defibrillators have improved survival for adult in hospital cardiac~     arrest. Automated external defibrillators are approved for children aged 1 year and older for~     out of hospital cardiac arrests. It is unknown whether automated external defibrillators have~     a role for in hospital pediatric cardiac arrests.~      The purpose of study is to compare the management of cardiac rhythm disorders by pediatric~     residents using an automated external defibrillator versus a standard defibrillator in~     simulated pediatric cardiac arrests.~      It is our hypothesis that residents using an automated external defibrillator will have a~     shorter time to defibrillation.~   "
222959|NCT00640341|"~     The objective of this study is to evaluate the performance of the PureVision Contact Lens~     compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear~     basis.~   "
222960|NCT00640328|"~     The trial consists of a dose escalation, to establish the safety of ofatumumab in RRMS~     patients. A 48-week treatment period followed by an individualized follow-up period until~     normalization of peripheral B-cell counts or Immunoglobulin G (IgG) levels.~   "
222961|NCT00640315|"~     This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic~     effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to~     chronic obstructive pulmonary disease (COPD).~   "
222962|NCT00640302|"~     This aim of this project is to evaluate the efficacy of neuraminidase inhibitors in patients~     who have a clinical diagnosis of pandemic influenza infection. The study is observational~     only. The primary measure used in this study will be mortality. Symptom severity and~     duration, treatment limiting side effects, demographic information and resistance will also~     be examined. This project will commence upon pandemic influenza being declared in Australia,~     Hong Kong or Singapore. Data will be analysed as quickly as possible to help inform the~     continued use of neuraminidase inhibitor therapy as a cornerstone of the public health agency~     response to pandemic influenza.~   "
222963|NCT00640289|"~     Congenital deficiency of Factor XIII is a rare but potentially life threatening disorder. It~     is inherited in an autosomal recessive fashion. Infusion of Factor XIII has proved to be~     useful for prevention and treatment of bleeding episodes, especially of spontaneous~     intracranial bleedings. In this study, Fibrogammin P will be given to patients with~     congenital Factor XIII deficiency and congenital/acquired FXIII deficiency to prevent~     bleeding and to treat established bleeding episodes. For Factor XIII prophylaxis to prevent~     hemorrhages, the dosage will depend on the weight of the subject. The frequency of Factor~     XIII administration will be determined by the factor's circulating half-life. During the~     first month only, a Factor XIII pharmacokinetic study will be determined over a 4-week~     period. Safety data will include accrual of information on viral safety, liver function,~     complete blood counts and adverse events. Historical data concerning spontaneous bleeds will~     be collected whenever possible two years prior to treatment with Fibrogammin P.~   "
222964|NCT00640276|"~     We will identify the influence of long-term treatment of Pitavastatin compared to~     non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic~     syndrome component score. And we will additionally observe the changes of CVD risk factors~     like lipid profile, abdominal fat, insulin resistance and so on.~   "
222965|NCT00640263|"~     The ANRS 12174 study is a clinical trial that will compare the efficacy and safety of~     prolonged infant peri-exposure prophylaxis (PEP) with Lopinavir/Ritonavir (LPV/r) versus~     Lamivudine to prevent HIV-1 transmission through breast milk in children born to~     HIV-1-infected mothers not eligible for HAART and having benefited from perinatal~     antiretroviral (ART) regimens. The study will recruit 1500 mother-infant pairs in 4 African~     countries.~      Study design:~      PROMISE PEP is a multinational, randomised double-blind controlled clinical trial.~      Intervention:~      Infants will be randomised to receive LPV/r or 3TC twice daily from day seven (± 2 days)~     after birth until 4 weeks after cessation of breastfeeding (BF). We will recommend exclusive~     BF (EBF) up till including the 26th week of life followed by a relatively rapid (maximum of 8~     weeks) cessation period. The maximum duration of PEP will thereby be 38 weeks.~      Primary objective:~      To compare the efficacy of infant LPV/r (40/10mg twice daily if 2-4kg and 80/20mg twice daily~     if >4kg) vs. Lamivudine 7,5mg twice daily if 2-4kg, 25mg twice daily if 4-8kg and 50mg twice~     daily if >8kg) from day 7 until 4 weeks after cessation of BF (maximum duration of~     prophylaxis: 50 weeks for a maximum duration of breastfeeding of 46 weeks) to prevent~     postnatal HIV-1 acquisition between 7 days and 50 weeks of age.~      Secondary objectives:~        -  To assess the safety of long-term infant prophylaxis with LPV/r versus Lamivudine~          (including resistance, adverse events and growth) until 50 weeks.~        -  HIV-1-free survival until 50 weeks~        -  To build clinical trials capacity at the four study sites.~      Main endpoint:~      Acquisition of HIV-1 (as assessed by HIV-1 DNA PCR) between day 7 and 50 weeks of age~      Study population:~      HIV-uninfected infants at day 7 (± 2 days) born to HIV-1 infected mothers not eligible for~     HAART who choose to breastfeed their infants and who have benefited from the national~     prevention of mother to child transmission (PMTCT) program during pregnancy and delivery. The~     study will recruit 1500 mother-infant pairs in Burkina Faso, South Africa, Uganda and Zambia.~      Study duration:~      Infants will be followed up for 50 weeks and the total study duration is five years.~      Expected outcome:~      This study will inform on the relative advantages (efficacy) and drawbacks of two~     interventions to support HIV-1-infected women not eligible for HAART to safely breastfeed~     their babies. If found to be safe and efficacious, the regimens would avoid the existing~     contradiction between optimal infant feeding and the prevention of MTCT through breast milk.~     Clinical trial capacity development will improve the future quality of trials conducted in~     these countries.~   "
222966|NCT00640250|"~     We propose a prospective, multi-center, double-blind, randomized study comparing the~     diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue~     106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a~     clinical history of contact dermatitis and a positive patch test (current or previous) to the~     corresponding reference petrolatum allergen (sensitives).~   "
222967|NCT00640237|"~     The purpose of the study is to examine the vitamin D state of elder patients in therapeutic~     departments and to compere the treatment during the hospitalization with the out-patient~     treatment.~   "
222968|NCT00640224|"~     The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl~     estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory~     markers, vascular markers and bone development in overweight adolescent females with~     polycystic ovary syndrome (PCOS).~   "
222969|NCT00640211|"~     This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as~     prophylaxis against pandemic influenza infection in patients who are prescribed a long term~     course in the context of a place of employment or profession. The study is observational~     only. The primary measure used in this study will be the incidence of symptomatic pandemic~     influenza in patients receiving prophylaxis. Seroconversion to pandemic influenza, the~     incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir~     prophylaxis will also be examined. This project will commence upon pandemic influenza being~     declared in Australia, Hong Kong or Singapore. Data will be analysed as quickly as possible~     to help inform the continued use of neuraminidase inhibitor therapy as a cornerstone of the~     public health agency response to pandemic influenza.~   "
222970|NCT00640198|"~     -  Aphasia, the loss or impairment of language caused by brain damage, is one of the most~          devastating cognitive impairments of stroke. Aphasia can be treated with combination of~          speech-language therapy and drugs. Conventional speech-language therapy in chronic~          aphasic subjects is of little help and several drugs have been studied with limited~          success. Therefore other therapeutic strategies are warranted.~        -  Recent data suggest that drugs (memantine) acting on the brain chemical glutamate may~          help the recovery of cognitive deficits, included language, in subjects with vascular~          dementia. The present study examines the safety profile and efficacy of memantine paired~          with intensive language therapy in subjects with stroke-related chronic aphasia (more~          than 1 yr. of evolution).~   "
222971|NCT00640185|"~     The purpose of this study is to test if the investigational medication ABT-089 is a safe and~     effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
222972|NCT00640172|"~     Eligible elderly men and women with anemia will undergo a full hematologic evaluation plus~     additional laboratory tests to determine the etiology of the anemia. In a subset of subjects,~     bone marrow aspirate and biopsies will be obtained for a planned analysis of erythroid~     progenitor and stem cells. Plasma; serum; and bone marrow samples will be will be compared to~     elderly non-anemic controls. Bone marrow samples will also be compared to non-anemic young~     controls (purchased).~   "
222992|NCT00639912|"~     The aim of the study is to test the efficacy of low versus high volume hydration and two~     different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast~     induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing~     primary PCI.~   "
222993|NCT00639899|"~     In varicocele the venous pressure in the prostatic bed is increased .This may result in~     raised hydrostatic pressure which in turn may stimulate prostatic hypertrophy.~      Restoring normal venous drainage is expected to lower hydrostatic pressure followed by~     inhibition of prostatic growth and possibly leading regression in prostatic dimensions.~   "
222973|NCT00640159|"~     Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is~     primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction~     with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations~     for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in~     the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B~     (MAO-B) activity is generally considered to be of primary importance.~      Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg~     daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of~     selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in~     the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and~     avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a~     lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no~     empirical data indicating whether the use of the new approved formulation of selegiline ODT~     (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is~     believed that clinical efficacy will be preserved or enhanced, by delivering more active~     drug, with improved patient preference for the ODT formulation due to the once-daily dosing .~      The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in~     the treatment of PD was established in a multicenter randomized placebo-controlled trial~     (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months'~     duration. Patients randomized to orally disintegrating selegiline received a daily dose of~     1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were~     all treated with levodopa and could additionally have been on dopamine agonists,~     anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks,~     orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less~     OFF time compared to baseline. Placebo treated patients had 0.6 hours per day less OFF~     time compared to baseline. These differences were significant (p < 0.001). Adverse events~     were very similar between drug and placebo.~   "
222974|NCT00640146|"~     The purpose of this study is to examine the safety and activity of MNTX in relieving~     opioid-induced constipation following orthopedic procedures.~   "
222975|NCT00640133|"~     This study will evaluate the safety and effectiveness of deep brain stimulation in treating~     people with severe and otherwise treatment-resistant obsessive-compulsive disorder.~   "
222976|NCT00640120|"~     The WIM-PC™ device, indicated for acoustic pulmonary function measurement that quantifies the~     presence of wheezing. This study was designed in order to evaluate the efficacy and safety of~     using the WIM-PC™ device for wheeze detection during dynamic bronchial situations in infants~     that were hospitalized as a result of asthmatic attack.~   "
222977|NCT00640107|"~     Magnetic Resonance Imaging (MRI) is a non-invasive diagnostic imaging technology that~     produces images of the body. This technology does not utilize radiation, as does Computed~     Tomography (CT) but relies on radio waves and a strong magnet to produce images.~      The purpose of this study is to evaluate new commercially available MR imaging sequence~     and/or hardware that have been installed on an existing MR unit or to evaluate a new MR unit.~     The study also serves to familiarize the MR technical staff with how to operate the new~     equipment. The information obtained will be used to optimize new MR equipment that has been~     installed on the MR scanner~      There are updated ultrasound machines that allow color Doppler images and elastography~     acquisition ability. Upgrades for software and hardware are on an ongoing basis along with~     new applications and imaging protocols.~      There are updated ultrasound machines that allow color Doppler images and elastography~     acquisition ability. Upgrades for software and hardware are on an ongoing basis along with~     new applications and imaging protocols.~      There are updated ultrasound machines that allow color Doppler images and elastography~     acquisition ability. Upgrades for software and hardware are on an ongoing basis along with~     new applications and imaging protocols~   "
222978|NCT00640094|"~     Background: Experimental studies have documented the beneficial effects of the endogenously~     produced antioxidant, melatonin, in reducing tissue damage and limiting cardiac~     pathophysiology in models of experimental ischemia-reperfusion. Melatonin confers~     cardioprotection against ischemia-reperfusion injury most likely through its direct free~     radical scavenging activities and its indirect actions in stimulating antioxidant enzymes.~     These actions of melatonin permit it to reduce molecular damage and limit infarct size in~     experimental models of transient ischemia and subsequent reperfusion.~      Study design: The Melatonin Adjunct in the acute myocaRdial Infarction treated with~     Angioplasty (MARIA) trial is a prospective, randomized, double-blind, placebo-controlled,~     phase 2 study of the intravenous administration of melatonin. The primary efficacy end point~     of this study is to determine whether melatonin treatment reduces infarct size determined by~     cardiac magnetic resonance 5-7 days post-reperfusion. Other secondary end points will be the~     clinical events occurring within the first year: death, sustained ventricular arrhythmias,~     resuscitation from cardiac arrest, cardiogenic shock, heart failure, major bleedings ,~     stroke, need for revascularization, recurrent ischemia, re-infarctions and rehospitalization;~     and changes in left ventricular ejection fraction from baseline to 4 months of follow-up.~      Implications: The MARIA trial tests a novel pharmacologic agent, melatonin, in patients with~     acute myocardial infarction and the hypothesis that it will confer cardioprotection against~     ischemia-reperfusion injury. If successful, the finding would support the use of melatonin in~     therapy of ischemic-reperfusion injury of the heart.~   "
222979|NCT00640081|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. It is not yet known whether giving combination chemotherapy together with~     intermittent cetuximab is more effective than combination chemotherapy given together with~     continuous cetuximab in treating colorectal cancer.~      PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together~     with intermittent cetuximab to see how well it works compared to combination chemotherapy~     given together with continuous cetuximab as first-line therapy in treating patients with~     advanced or metastatic colorectal cancer.~   "
222980|NCT00640068|"~     The ACIC is a Collaborative Quality Improvement (CQI) program involving the collection of~     data related to: indications for Coronary Computed Tomography (CCTA), patient health~     characteristics, acquisition techniques of CCTA scans, physician interpretation of results~     and short-term outcomes over a 90 day period.~   "
222994|NCT00639873|"~     A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate~     monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.~   "
222995|NCT00639860|"~     The purpose of this study is to evaluate clinically, histologically and radiographically the~     healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12~     weeks following exodontia.~   "
222981|NCT00640055|"~     The NICHD Global Network (GN) for Women's and Children's Health Research, a multi-site,~     international research network, provides a unique infrastructure to implement an expanded~     perinatal verbal autopsy study using the FIRST BREATH trial as its platform. The FIRST BREATH~     trial is an ongoing study of neonatal resuscitation training in rural community settings~     within Global Network sites in Central Africa, Asia and Latin America.~      This study uses a validated VA questionnaire to determine COD of stillbirths and early~     neonatal deaths among participants in the FIRST BREATH study. We propose to expand the~     usefulness of perinatal verbal autopsy methodology in two ways. First by assessing whether~     the Community Coordinator (a non-physician health worker) can assign COD with a high level of~     concordance comparable to a Physician Panel, and second, whether the FIRST BREATH Birth~     Attendant can provide as reliable perinatal information as the mother during the VA~     interview. Our primary hypothesis is that the COD assigned by the FIRST BREATH Community~     Coordinator will be the same as the COD assigned by the Physician Panel in greater than 70%~     of early neonatal deaths (ENDs), when both use the same VA and FIRST BREATH data.~   "
222982|NCT00640042|"~     The purpose of this study is to provide information in a broad, real world population of~     chronic pain patients assessing both pain control with AVINZA as well as the potential risk~     for misuse and abuse.~   "
222983|NCT00640029|"~     Until now, arthrodesis (intervertebral fusion) is the formal treatment for the lumbar and~     cervical degenerative disc disease : arthrodesis has been the standard surgical treatment for~     the patients when nonsurgical management has failed. However , it has shown out some~     drawbacks : pseudoarthrosis may appear in the short term, and junctional degeneration in the~     long term.~      The replacement of the intervertebral disc by a prosthesis (arthroplasty) has been since a~     few years a major alternative therapeutic to the arthrodesis.: it demonstrates great~     functional results and less post-interventional complications. It is indicated to restore a~     normal function of the spine (motion is kept)and to avoid deterioration of the adjacent~     spinal segments over the long time.~      In this clinical study, we will distinguish the cervical discal pathology and the lumbar~     discal pathology.~      The purpose of this study is to analyze the results of the arthroplasty in terms of~     functional effects, quality of life, anatomical results and economical results.~   "
222984|NCT00640016|"~     To investigate the effects of CAT-354 on airway hyper-responsiveness (AHR) in uncontrolled~     asthma.~   "
222985|NCT00640003|"~     This research is being done to find out if Baclofen, a medicine that is often used for the~     treatment of abnormal stiffness, might also be useful to treat some of the neurologic~     problems caused by ataxia telangiectasia (A-T). The investigators also want to find out if~     there are better ways to measure the problems of ataxia and abnormal eye movement for future~     studies of medication in ataxia telangiectasia.~   "
222986|NCT00639990|"~     The hypothesis is that brain injury patients have alterations of the respiratory system~     related to intraabdominal pressure. Furthermore application of moderate levels of PEEP may~     improve respiratory function in these patients.~   "
222987|NCT00639977|"~     To evaluate the short-term effect of acupuncture on the intraocular pressure (IOP).~      Methods: A randomized controlled trial. Healthy volunteers will be randomly allocated to~     three groups: Acupuncture group - will be submitted to a 20-minute session of acupuncture~     with needles inserted in specific points (Tong Zi Liao, Yang Bai and Jing Ming); Sham group -~     will be submitted to a 20- minute session of acupuncture with needles inserted in false~     points located 1 cm from true points in areas without acupuncture's meridians; and Control~     group - no intervention. IOP measurement by a masked investigator using Goldmann applanation~     tonometry immediately before the intervention, as well as 30 minutes and 24 hours after the~     acupuncture.~   "
222988|NCT00639964|"~     Justification:~      Intrauterine exposure to type 1 or type 2 diabetes increase the risk of macrosomia (35 % to~     50 % versus 10 % in general population) despite a good glycemic control. The consequences are~     : shoulder's dystocia, lung immaturity, caesarean section, neonatal hypoglycaemia and a high~     frequency of obesity and metabolic disorders in adults.~      The mechanisms of macrosomia are unclear; chronic hyperglycemia and subsequent~     hyperinsulinaemia observed during the diabetic pregnancy might explain only partially the~     fetal weight. Considerable interest has been generated over the last decade on the lipids and~     fatty acids alterations in diabetes pregnancies. Change in lipoproteins metabolism have been~     described associated with macrosomia. Maternal nutrition before and during pregnancy plays an~     important role in fetal growth and subsequent development of an increased susceptibility to~     obesity and diabetes in later life.~      Main objective:~      Looking for an association between maternal and fetal blood lipid parameters and birth weight~     and body fat in a context of type 1 or type 2 diabetes.~      Secondary objectives:~        -  Identify lipid markers associated with fetal macrosomia.~        -  Analyze the placenta by measuring the expression of genes implicated in the storage and~          the transfer of fatty acids.~        -  Analyze and compare the expression level of placental genes subjected to parental~          imprinting and validated in animal models.~   "
222989|NCT00639951|"~     The purpose of this study is to compare whether a same total dose given up front as a single~     dose is more effective and as safe as the same dose given as a fractioned dose.~      Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation~     Test Results (fibrinogen, platelets, INR, PT and PTT).~      Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and~     Antivenom Levels and the Progression of Local Lesions.~   "
222990|NCT00639938|"~     The increase in pediatric HIV infection has a substantial impact on childhood mortality in~     the developing world. A number of recent studies suggest that as many as half or more of~     mother-to-child HIV transmissions in developing countries occur in late pregnancy or during~     labor and delivery. Interventions targeted during the perinatal period have shown to be~     effective and to have a significant impact in reducing transmission. The purpose of this~     study is to investigate the effectiveness of nevirapine (NVP) plus immunoprophylaxis or~     extended NVP dosing regimens in HIV-infected pregnant women and their infants during the~     perinatal period.~   "
222991|NCT00639925|"~     The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402~     restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination~     with gemcitabine~   "
224581|NCT00618852|"~     The purpose of this study is to investigate the effects of intravenous furosemide on~     cardio-respiratory performance in neonates receiving a packed red blood cell (PRBC)~     transfusion who are considered at high risk of volume overload.~   "
222998|NCT00639821|"~     This study investigated the mucosal gene expression defects associated with active Crohn's~     disease (CD)and ulcerative colitis (UC), and studied the effect of infliximab induced~     downregulation of inflammation and mucosal healing on these abnormalities, using whole genome~     gene expression microarrays.~   "
222999|NCT00639808|"~     The purpose of this study is to determine whether TZP-101 is safe in people with diabetes.~     Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic~     patients.~   "
223000|NCT00639795|"~     The purpose of this study is to compare:~        1. The degree of systemic postoperative inflammation (cytokine measurement) with the degree~          of post-operative pain~        2. The degree of pain and nausea and~        3. The pre and post operative pulmonary functions~      following Video Assisted Thorascopic Surgery (VATS) performed under general anesthesia with~     the addition of intra-operative single-injection paravertebral blockade vs general anesthesia~     with a sham intra-operative paravertebral nerve blockade~   "
223001|NCT00639782|"~     The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is~     reduced as compared to the SJM prosthesis.~   "
223002|NCT00639769|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating~     recurrent or metastatic head and neck cancer.~   "
223003|NCT00639756|"~     Studies in animals have found that allopurinol can markedly improve fructose induced~     metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP,~     reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose~     diet.~   "
223004|NCT00639743|"~     Heparin is the reference therapy for most patients with pulmonary embolism. Some patients~     with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the~     right ventricle have a higher mortality risk. It has been suggested that thrombolytic~     treatment, a drug that dissolves blood clots more rapidly, may reduce the mortality in those~     patients. The studies reported to date were unable to confirm or refute this hypothesis~     because the number of patients included in those studies is too low. The aim of the study is~     to compare thrombolytic treatment with heparin (which is the reference therapy for pulmonary~     embolism) in a large group of patients with sub-massive pulmonary embolism.~   "
223005|NCT00639730|"~     This research is being done to find out if the Atkins Diet can be used safely and effectively~     to reduce seizures in children who have Sturge Weber syndrome.~      The ketogenic diet is a proven therapy for epilepsy, but can be difficult to use in children.~     The Atkins Diet is a high fat, high protein, low carbohydrate diet introduced in the 1970s to~     help with weight loss. It is different from the ketogenic diet in four major ways: no calorie~     restriction, no fluid restriction, no protein restriction, and is easy to start outside the~     hospital. People on the Atkins Diet become ketotic (produce high levels of ketones, a certain~     substance in the body), like patients on the ketogenic diet, and the investigators believe~     this may lead to seizure control.~      Children aged 2-18 with Sturge Weber syndrome and seizures at least monthly, who have used at~     least two anti-seizure drugs may join. 5 children in total will be enrolled.~   "
223006|NCT00639717|"~     This research study investigates the benefits and possible risks of adding both etanercept~     (Enbrel) and ECP (extracorporeal photopheresis) to the conventional preventative (or~     prophylactic) treatments for graft-versus-host disease (GVHD). GVHD is a common, serious, and~     too often fatal, complication after matched unrelated donor stem cell transplantation,~     regardless of the pre-transplant conditioning regimen used (full or reduced intensity).~      Reduced intensity transplants which employ lower doses of chemotherapy during the~     conditioning phase of the transplant, are less toxic than full intensity transplants. Reduced~     intensity transplants may extend the unrelated donor transplant option to older patients or~     to patients with existing medical conditions or illness, where a full intensity transplant is~     not possible. To be successful, reduced intensity transplants need to offset any lower~     effectiveness in killing cancer cells during the conditioning phase, with the establishment~     of a donor cell, graft-versus-leukemia effect (GVL). The GVL effect and GVHD are associated~     with each other and therefore, the goal of GVHD prophylaxis for this study is not so much to~     prevent all GVHD, but rather to prevent serious and fatal acute GVHD.~      Most GVHD-related deaths are either the direct consequence of severe GVHD or from infections~     associated with intense immunosuppression, a consequence of the standard treatments for acute~     GVHD, which almost always include high-dose steroids. A more effective prophylaxis therapy~     that allows for the GVL effect to develop, while limiting the exposure to high-dose steroids~     may reduce transplant mortality and morbidity. We also will study how key chemical and~     cellular factors relate to clinical outcome.~   "
223007|NCT00639704|"~     The purpose of this study is to compare the MRI results with the new SPECT image~     reconstruction method, this study will allow us to determine whether a new more accurate~     method of looking at the heart by nuclear study can be used in routine clinical use.~   "
223008|NCT00639691|"~     This study has the objective of providing compassionate use access to omalizumab (Xolair) and~     to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain~     symptomatic despite optimal therapy according to GINA step 4 treatment guidelines.~   "
223009|NCT00639678|"~     To evaluate the safety and tolerability of raxibacumab in healthy subjects.~   "
223010|NCT00639665|"~     Observing how cocoa effects the cardiovascular and renal system.~   "
223011|NCT00639652|"~     Currently, we conduct a prospective, randomized trial comparing the outcome of surgical~     excision with the outcome of curettage in nodular and superficial BCCs. Larger BCCs and~     micronodular or sclerosing BCCs are not included in the randomized study. They are mainly~     operated using three-dimensional histology (3D-histology, micrographic surgery). In this~     observational study we measure the cosmetic result and the recurrence rate of all BCCs not~     included in the randomized trial.~   "
223040|NCT00639262|"~     Sorafenib™ has the potential to inhibit tumor growth, tumor angiogenesis , and enhance~     radiation response. This study will test the combination of Sorafenib™ and radiation therapy~     with or without temozolomide to determine tolerance of the combined treatments. Defining safe~     dosing of Sorafenib™ in this combination therapy will be achieved.~   "
223012|NCT00639639|"~     RATIONALE: Vaccines may help the body build an effective immune response to kill cancer~     cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy~     together with radiation therapy and chemotherapy may kill more cancer cells.~      PURPOSE: This randomized phase I/II trial is studying how well vaccine therapy works in~     treating patients with newly diagnosed glioblastoma multiforme recovering from lymphopenia~     caused by temozolomide.~   "
223013|NCT00639626|"~     This is a study to find out if Levemir® (a long acting or basal insulin) is safe and~     effective in treating cystic fibrosis related diabetes (CFRD).~   "
223014|NCT00639613|"~     The purpose of this study is to determine whether excessive secretion of glucagon in type 2~     diabetes originates from the pancreatic alpha-cells or endocrine cells in the mucosa of the~     small intestinal.~   "
223015|NCT00639600|"~     This research project is supported by a multicentric network of collaborators whose goal is~     to assess the efficacy of transplanting allogenic pancreas islets to restore insulin~     secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney~     transplantation and to improve their metabolic control.~   "
223016|NCT00639587|"~     Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in~     Japan. The objective of the study was to compare the efficacy and safety of cetirizine~     hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial~     allergic rhinitis.~   "
223017|NCT00639574|"~     The administration of néfopam after initial treatment by kétoproféne, could obtain, in~     patients remaining pain and classically need morphine, analgesia at least the same as~     morphine alone. The use of néfopam second line after ketoprofen could reducing (or even~     eliminating) the need for morphine (and its side effects), allowing a reduction in the length~     of stay of patients in the emergency unit.~      The main objective is to show that the addition of a néfopam initial treatment with the~     kétoproféne, reduces, in patients with ureteral calculi, the percentage of patients requiring~     the use of a treatment by morphine.~      The secondary objective is to reduce the side effects caused by the morphine, shorten the~     time to install the appropriate level of analgesia while reducing the risk of failure of the~     titration morphine, reduce the time spent on titration of morphine and reduce the length of~     stay patient intake in emergency unit.~   "
223018|NCT00639561|"~     The main objective of the study is to realized a collection of feces in order to study the~     modification of the intestinal microflora according to alimentary fibres~   "
223019|NCT00639548|"~     Most critically ill patients receive sedative and analgesic drugs to attenuate discomfort and~     pain. The excessive use of sedatives and analgesics has undesirable effects for patients.~     Whereas undersedation is mostly easy to identify, oversedation with its associated problems~     is more difficult to recognize. Stopping sedation daily helps to avoid gross oversedation,~     but this is not always possible. Monitoring the depth of sedation is difficult and is~     currently based on clinical assessment and the use of clinical scoring systems. These scoring~     systems cannot be applied continuously, they are subjective and the level of consciousness~     can be altered when sedation is assessed.~      Several methods based on the electroencephalogram have been tested to avoid these problems,~     but the results have been disappointing so far, so the BIS Monitor an dthe Entropy monitor.We~     have previously shown that the time-locked cortical response to standard external stimuli~     (long-latency auditory evoked potentials or event-related potentials; ERPs) can discriminate~     between clinically relevant light to moderate and deep sedation levels in healthy volunteers,~     when sedation is induced with a combination of propofol or midazolam with remifentanil.~      We therefore hypothesized that ERPs may be used to monitor the depth of sedation in ICU~     patients as well. As the first step to test this hypothesis, we evaluated the use of ERPs to~     assess the level of sedation in patients undergoing elective major surgery and admitted to~     the ICU for short term postoperative mechanical ventilation.~   "
223020|NCT00639535|"~     This is a study looking at advanced imaging such as PET/CT and MRI to see if they can provide~     a more accurate assessment of the patient with dense breasts or difficult to interpret~     mammograms. In addition, the ability to determine whether one or the other is more accurate~     or whether both together would be appropriate in this clinical situation, may be able to be~     measured.~      The MRI studies are very sensitive for detection of breast histopathology but less specific~     in differentiating between small low grade malignancies are more benign pathologies.~     Multifocal pathology can be challenging in determining site(s) for biopsy.~      PET scanning is specific in the measurement of metabolic glucose activity of various~     histopathologies and is accurate in differentiating aggressive from benign pathology in~     multifocal breast disease. A further drawback of PET is the lack of ability to observe~     lesions less than 3-4mm in diameter.~      In select cases the combination of MR and PET/CT is able to come to a more conclusive~     diagnosis - specifically with bilateral or multifocal breast disease.~   "
223021|NCT00639522|"~     The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics~     of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced~     gastric carcinoma.~   "
223022|NCT00639509|"~     This phase II trial is studying how well IMC-A12 works in treating patients with advanced~     liver cancer. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them.~   "
223023|NCT00639496|"~     The purpose of this study is to determine whether NAC added to prednisone, and azathioprine~     has a better effect on lung function, radiology and clinical condition than placebo +~     prednisone in combination with azathioprine after 6 and 12 months.~   "
223024|NCT00639483|"~     To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus~     risperidone alone in patients with schizophrenia~   "
223025|NCT00639470|"~     The objective of this study is to test legal guardians reading comprehension of their child's~     post-operative medication administration using three different versions of written medication~     information (standard fact sheets, easy-to-read fact sheets, and easy-to-read fact sheets~     accompanied by illustrations).~   "
223041|NCT00639249|"~     The purpose of this study is to evaluate the safety and tolerability of SA4503 in patients~     recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to~     placebo.~   "
223026|NCT00639457|"~     The purpose is to examine the safety and efficacy of 16wks of pioglitazone (Actos; 30mg/d)~     with and without aerobic and strength exercise training for reducing glucose intolerance and~     central adiposity in HIV-infected people. We anticipate that pioglitazone + exercise training~     will improve glucose metabolism and insulin sensitivity, and reduce central adiposity more~     than pioglitazone alone. These improvements should translate into reduced cardiovascular~     disease risk in HIV-infected people.~   "
223027|NCT00639444|"~     The purpose of this study is to determine whether age at introduction of gluten-containing~     cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development~     in infants with a first-degree relative affected by CD.~   "
223028|NCT00639431|"~     Because bilateral lower extremity amputees do not have an intact limb for use with the~     mirror, we are now proposing to conduct a pilot trial of two treatments for phantom limb pain~     (PLP) - direct observation of another person's foot moving versus mental visualization. The~     trial will last for 4 months and during the first month data will be gathered daily on the~     number of episodes of phantom limb pain, the average length of episodes, and the average~     intensity of pain in each phantom leg. In addition, the rapidity of pain relief, the length~     of therapy needed to sustain long-lasting pain relief, and whether use of these two treatment~     methods during rehabilitation can provide sustained and/or permanent pain relief will be~     determined. This study will test the hypothesis that direct observation of a limb while~     performing phantom limb movements will reduce phantom limb pain more than mental~     visualization of the phantom limb alone in subjects who have sustained a traumatic bilateral~     lower limb amputation.~   "
223029|NCT00639418|"~     The purpose of this study is to describe flu vaccine coverage in children under 18 years of~     age and to examine correlations between in-office flu vaccine coverage and the use of various~     tactics to increase vaccine coverage.~   "
223030|NCT00639405|"~     The purpose of this study is to design a method to better localize parathyroid adenomas. This~     study will include approximately 6 patients who have not had surgery and another 25 patients~     who have already had surgery over the course of one year.~   "
223031|NCT00639392|"~     The long-term goal of this study is to learn if Zoledronic Acid can prevent or reduce pain in~     sickle cell disease. The goal of this study is to learn about the safety of Zoledronic Acid~     in persons with sickle cell disease who experience chronic pain requiring medical treatment~     or use of narcotics.~   "
223032|NCT00639379|"~     The purpose of this study is to evaluate and compare the clinical performance of two toric~     contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized,~     bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance~     of the test lens over the control lenses for comfort, vision, and toric fit characteristics~     as well as corneal integrity~   "
223033|NCT00639366|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known~     whether radiation therapy directed at the head is effective in preventing brain metastases in~     patients with advanced cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to the head to see how~     well it works in preventing brain metastases in women receiving trastuzumab and chemotherapy~     for metastatic or locally advanced breast cancer.~   "
223034|NCT00639353|"~     This study seeks to evaluate the clinical performance of a recently released contact lens~     designed to correct astigmatism to an established contact lens that has historically been~     used in these patients.~   "
223035|NCT00639327|"~     The purpose of this study is compare overall survival of the test arm (CPT-11/S-1~     combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced~     gastric cancer.~   "
223036|NCT00639314|"~     The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed~     gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life~     (QOL).~   "
223037|NCT00639301|"~     The purpose of this study is to find out about the quality of life and health in a group of~     adults who had retinoblastoma when they were children. By quality of life, we mean how you~     are feeling about being satisfied with things in your life, including your physical health,~     your emotional health, and your ability to carry out daily activities. We hope that this~     information will help us provide better care to future children with retinoblastoma and~     better follow-up care for survivors of retinoblastoma.~   "
223038|NCT00639288|"~     Objective: To develop a detailed treatment manual that modifies the existing CPT-C treatment~     protocol to allow for concurrent treatment of PTSD and AD, and to obtain some pilot data~     regarding its efficacy.~      Hypothesis: We predict that CPT-C will significantly reduce the number of drinking days~     (measured by the Timeline Follow Back Method [TLFB]) and reduce the symptoms of PTSD~     (measured by the [CAPS and PCL] scores).~      Design: This is a non-randomized, prospective study in which all participants will receive~     the modified CPT-C for 12 weeks by trained CPT-C clinicians, with each session lasting~     approximately 1-1.5 hours). Modifications to CPT-C include psychoeducation about alcohol use~     as an avoidance of PTSD symptoms integrated throughout treatment, integration of coping~     skills training for AD, weekly breathalyzer tests to measure blood alcohol level, and use and~     collection of daily dairies of alcohol use.~   "
223039|NCT00639275|"~     Patients with Parkinson's disease (PD) frequently experience upper gastrointestinal~     disorders. During the disease, weight loss is often noticed. Recently, many studies have~     demonstrated that STN-DBS improved extrapyramidal symptoms. Interestingly, PD patients gain~     weight after STN-DBS, at least in part due to a decrease in resting energy expenditure.~      Purpose: To evaluate benefits of STN-DBS on upper gastrointestinal symptoms and motility.~      Patients et method: PD patients waiting for STN-DBS, will be assessed in a preoperative time~     (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on~     upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of~     chronic STN-DBS. Each assessment will include : 1/ questionnaires about frequency and~     severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index,~     dietary assessment); 3/ the gastric emptying measurement with the 13C-octanoic acid breath~     test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect~     calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin~     concentrations, hormones involved in the homeostatic regulation of appetite.~      Perspectives: This physiopathological study should allow us to understand the mechanisms of~     the effects of STN-DBS on upper gastrointestinal symptoms and weight regulation in PD~     patients.~   "
223042|NCT00639236|"~     The use of inhaled hypertonic saline has been extensively documented in asthma,~     bronchiectasis, cystic fibrosis and COPD as method of bronchial challenge and sputum~     induction, but studies that evaluated others endpoints are required. The objective of this~     study was to analyse the effects of inhaling hypertonic saline compared with placebo with~     respect to functional exercise capacity, dyspnoea and quality of life. In a double-blind~     randomised parallel placebo-controlled trial, conducted at the Clínicas Integradas of the~     Evangelical Faculty of Paraná,sixty-eight patients (age 67 ± 6.5 years; FEV1 38.9 ± 16.2~     predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34), combined~     with a program of exercise, three times a week, for 8-weeks.~   "
223043|NCT00639223|"~     This study will examine the effect of red yeast rice extract compared to pravastatin on~     muscle related complaints in individuals with high cholesterol who have previously been~     unable to tolerate statin medications due to muscle pain. The study will determine whether~     red yeast is associated with a lower level of muscle related complaints compared to~     pravastatin.~   "
223044|NCT00639210|"~     A Finnish Breast Cancer Group Study (BREX 01-2004). A multicenter phase III open randomised~     trial of the efficacy of exercise in the prevention of long-term adverse effects of adjuvant~     treatments and breast cancer recurrences in women with primary breast cancer. The aim of the~     study is to investigate whether regular exercise training could reduce the long-term side~     effects of adjuvant treatments of primary breast cancer and improve quality of life and well~     being.~   "
223045|NCT00639197|"~     The purpose of the study is to determine if tunneling standard short-term central lines for a~     short distance under the skin, with the assistance of ultrasound imaging, reduces the risk of~     central line infections for catheters placed in the neck vein.~      Previous work has shown that these lines can be tunneled without ultrasound guidance. We wish~     to determine if the use of ultrasound makes the tunneling procedure safer and easier.~   "
223046|NCT00639184|"~     We plan to test a home-based parent-provided early developmental intervention (EI) both in~     infants with mild to moderate birth asphyxia and in infants without perinatal complications~     who will constitute a healthy comparison group in a randomized controlled trial. The trial~     will evaluate the effect of a resource-intensive early intervention (EI) program on the~     outcomes in infants born in rural communities in Zambia, India, and Pakistan. It will consist~     of frequent interaction (every 2 weeks the first year and every 4 weeks the second and third~     years) between parents and the parent trainer. The control group will receive enhanced health~     counseling (HC).~      The overall goal will be to implement and evaluate an EI program for infants following birth~     asphyxia, which is sustainable in developing countries. The challenge will be to adapt~     programs demonstrated to be effective in developed countries to the circumstances of the~     developing world, while reducing the demands on resources. Because there are limited data on~     normative development and EI programs in developing countries, a group of infants without~     perinatal complications will also be randomized to the same conditions in order to provide a~     comparison of what may be achieved from the intervention in healthy infants in developing~     countries. A final aim will be to address individual variation in EI effects that could be~     due to child and/or family characteristics.~      A randomized controlled experimental design will be used, in which infants who survive~     following birth asphyxia are randomly assigned to either EI or enhanced health education~     counseling (HC). The trial will randomize infants to a home-based parent-provided early~     developmental intervention (EI) with frequent home interaction between parents and parent~     trainers vs. HC. A group of infants without birth asphyxia or other major perinatal~     complications also will be randomized. Children will be examined by masked examiners at three~     time points (12, 24, and 36 month's assessments).~   "
223047|NCT00639171|"~     Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of~     biochemical properties of tissue. While MRS does not generate images of tumor per se it~     allows biochemical spectroscopic data to be obtained in vivo from user defined~     region-of-interest. In this manner, biochemical information elucidated by MRS can be~     interpreted in relation to detailed anatomy and images of metabolite distribution can be~     created. The aim of MRS is to identify presence and concentration of metabolites~     characteristic for normal and abnormal (tumor) cellular activities hence allow differential~     normal tissue from pathological tissue, as well as allow differentiating malignant from~     benign tumors.~   "
223048|NCT00639158|"~     The primary purpose of this study is to compare the safety and efficacy of ABT-335~     (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin~     coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.~   "
223049|NCT00639145|"~     The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated~     by HIV-positive pregnant women and their infants in South Africa and Zambia.~   "
223050|NCT00639132|"~     There have not been longitudinal studies which track patients' neurologically or~     developmentally in a systematic manner. By simultaneously tracking patients' neurodevelopment~     along with neuroimaging and neurophysiologic studies it becomes much easier to draw~     conclusions on the differential effects of the disease process and any available treatments~     that patients might receive. In addition, many of the gene mutations, which cause MLD have~     not been linked to the age of onset or the expected disease course.~   "
223051|NCT00639119|"~     The progressive myoclonus epilepsy of the Unverricht-Lundborg disease (ULD) type is an~     autosomal recessive disease characterized by progressive stimulus-sensitive and~     action-related myoclonic jerks.~      The mainstay of the current treatment in myoclonic epilepsies including ULD are valproic acid~     and clonazepam among several other antiepileptic drugs. Unfortunately the disease may often~     be resistant to antiepileptic drugs leading to major reductions in daily activities and~     disability to walk without assistance. Therefore new treatment modalities are needed.~     Experimental treatments of ULD patients with dopamine agonists have relieved myoclonic~     symptoms. Further, in accordance with this, a recent study indicates decreased dopaminergic~     neurotransmission in the basal ganglia of ULD patients, determined by PET.~      The purpose of this study is to investigate the effect of dopaminergic medication (ropinirole~     hydrochloride, Requip ®) on relieving the symptoms of ULD patients. Patients will undergo~     sixteen weeks intervention period. The main efficacy determinants are changes in unified~     myoclonus rating scale (UMRS), nerve conduction, multi-modality evoked potentials including~     visual evoked potential (VEP), somatosensory evoked potential (SSEP) and brainstem auditory~     evoked potential (BAEP), blink reflex habituation and electroencephalography (EEG).~     Tolerability and the safety of the medication are determined. The study setting is placebo~     controlled, crossover, two-group and double blind study.~   "
223066|NCT00638924|"~     To analyze the alterations of physiologic variables in healthy sedentary women in the Shuttle~     Walk Test, verify the distance reached and interruption causes of the test.~   "
223067|NCT00638911|"~     The aim of this therapeutic observation is to demonstrate the efficacy and safety of~     telmisartan or telmisartan and HCTZ in the treatment of patients with mild-to-moderate~     essential hypertension under normal conditions of use after market launch.~   "
223052|NCT00639106|"~     Following mastectomy (removal of your breast), reconstruction of your breast(s) can be~     performed using tissue expanders and implants. At the same operation as your mastectomy, a~     tissue expander is put under the skin and muscles of your chest.~      Following your surgery, the tissue expander is gradually filled with salt water over a period~     of months. Once the expander is filled to the size of your new breast, a second operation is~     performed. At this time, the tissue expander is removed and a permanent breast implant is~     placed. This is a standard procedure. We are interested in learning about the use of AlloDerm~     in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in~     order to cover and protect a tissue expander. We want to know if the use of AlloDerm can~     decrease your pain or discomfort after surgery and after the filling of your tissue expander.~      AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your~     body to reject it are removed. When it is placed in your chest, your own cells will then grow~     into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will~     either have reconstruction with AlloDerm or without AlloDerm.~   "
223053|NCT00639093|"~     The investigators reported in a pilot study presented at last year's Cybertherapy Conference~     (Girard & Turcotte, 2007) that using an action-cue exposure strategy in virtual reality~     (ACE-VR; crushing virtual cigarettes) might be useful in the treatment of tobacco addiction.~      The investigators are pursuing research in this area with a randomized control trial based on~     90 smokers who will receive a brief psychosocial smoking cessation program (25 people are~     enrolled so far and we expect to finish the study before the conference). During the first~     four weeks of an eight-session psychoeducational and motivational program, all participants~     will be immersed in VR. During the immersions in VR, 45 of the participants will use a~     virtual arm to catch and crush virtual cigarettes. The other half of the sample will use the~     virtual arm to catch virtual fruits (control condition).~      The smoking frequency, and abstinence, will be assessed with a daily diary and exhaled carbon~     monoxide tests (the CO2 tests will provide an objective confirmation of the abstinence~     reported in the diaries). The success the program will be compared based on the number of~     subjects who quitted or reduced their smoking frequency. The severity of addiction will be~     assessed with two questionnaires, the Fagerstrom and the Horn tests. Craving and withdrawal~     effects will be measured with the Minnesota Nicotine Withdrawal Scale (MNWS) and the Brief~     Questionnaire of Smoking Urges (QSU-Brief) at the baseline and at the visits from weeks 1~     through 4, 6, 12 and at the end of the program. Before the VR immersion, the Immersive~     Tendencies Questionnaire will be administered and after each VR session participants will~     fill two questionnaires addressing presence and cybersickness. The comparative impact of both~     treatments will be tested with repeated measures ANOVAs (and planned contrasts) with~     sufficient power to detect medium effect sizes.~      The main goal of our study is show that crushing virtual cigarettes can boost the impact of a~     behavioural program dedicated to cigarette addiction.~   "
223054|NCT00639080|"~     Purpose:~      To assess prior need for lipid lowering therapy in patients with type 2 diabetes.~      Background/Hypothesis:~      At present, lipid lowering therapy, usually with a HMG-CoA reductase inhibitor or statin,~     is recommended therapy for selected patients with type 2 diabetes mellitus (DM). The use of~     statins for primary prevention of CVD is not clear. Some primary prevention studies have~     found a statistically significant benefit but others have not (CARDS and ASPEN).~      Although low-density lipoprotein (LDL) has traditionally been a key marker of cardiovascular~     disease risk (CVD) risk and thus a guide to statin treatment, in recent years apolipoprotein~     B (apoB) has emerged as an independent risk factor for CVD.~      In a recent study, Tildesley H. et al. showed that in 500 patients with type 2 DM not on~     lipid lowering therapy there was discordance between LDL and apoB values. Specifically, it~     was found that among patients who fail to achieve the LDL-C target, 13% of men, 24% of women~     less than 50 and 13% of women greater than 50 meet the apoB target. In other words, while the~     LDL level would indicate treatment, the apoB level would not.~      Objectives:~      The investigators propose to measure lipid parameters during lipid lowering therapy and~     compare this with lipid parameters at one and two months after discontinuation of therapy in~     selected patients with type 2 DM at low risk for CVD. Lipid parameters to be measured~     include: high-density lipoprotein (HDL) - cholesterol, LDL-cholesterol, triglycerides, total~     cholesterol, total cholesterol: HDL-cholesterol ratio and apoB. As well, A1C will be~     measured.~   "
223055|NCT00639067|"~     To demonstrate and validate a breath test for detection of early stage lung cancer that could~     potentially reduce number of deaths.~   "
223056|NCT00639054|"~     Observational study investigating prognostic factors in newly diagnosed and relapsed multiple~     myeloma patients by use of clinical data, biochemical markers (blood samples), cytogenetic~     markers and gene expression profiling (myeloma cells from fresh bone marrow samples).~     Enabling future genetic studies by establishing a biobank of bone marrow and peripheral blood~     samples.~   "
223057|NCT00639041|"~     The study was performed to investigate the effects of n-3 LC-PUFA supplemented dairy products~     cardiovascular risk factors in hypertriglyceridemic patients.~   "
223058|NCT00639028|"~     The aim of our study is to determine the most efficient radiologic examination to assess the~     ankle sprain seriousness and so improve the therapeutic care.~   "
223059|NCT00639015|"~     The present study was conducted as a prospective, randomized, controlled study to compare:~        -  the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in~          patients with catecholamine-dependent septic shock~        -  to test the hypothesis that norepinephrine may likewise better preserve hepatosplanchnic~          perfusion versus phenylephrine in patients suffering from septic shock~   "
223060|NCT00639002|"~     The purpose of this study was to determine clinical efficacy and safety of ruxolitinib~     (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory~     or relapsed multiple myeloma.~   "
223061|NCT00638989|"~     To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous~     administration compared with intravenous administration.~   "
223062|NCT00638976|"~     Randomized, blind controlled, Multicenter, spontaneous, prospective trial, roughly 20~     enrolling centers in Italy, placebo and active drug supply given by GlaxoSmithKline (GSK).~   "
223063|NCT00638963|"~     The purpose of this study is to determine whether temozolomide can be used as a prophylaxis~     against brain recurrence in participants with metastatic breast cancer.~   "
223064|NCT00638950|"~     The effects of n-3 LC-PUFA-supplemented dairy products on inflammation and immunological~     parameters, biomarkers of oxidative stress, serum lipids, and disease activity were~     determined in patients with rheumatoid arthritis (RA).~   "
223065|NCT00638937|"~     This phase II trial is studying how well saracatinib works in treating patients with~     recurrent, stage IIIB or stage IV non-small cell lung cancer previously treated with~     combination chemotherapy that included cisplatin or carboplatin. Saracatinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
223068|NCT00638898|"~     RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the~     growth of tumor cells by stopping them from dividing or killing them. Giving~     colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the~     blood so they can be collected and stored. Chemotherapy is then given to prepare the bone~     marrow for the stem cell transplant. The stem cells are then returned to the patient to~     replace the blood-forming cells that were destroyed by the chemotherapy.~      PURPOSE: This clinical trial is studying how well giving busulfan, melphalan, and topotecan~     hydrochloride together with a stem cell transplant works in treating patients with newly~     diagnosed or relapsed solid tumor.~   "
223069|NCT00638885|"~     The purpose of this project is to measure brain markers and cognitive factors in twins with a~     history of military service with and without PTSD, and to follow them over time and measure~     changes in brain function and cognitive variables.~   "
223070|NCT00638872|"~     The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in~     improving the healing of diabetic foot ulcers.~   "
223071|NCT00638859|"~     The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7~     days in children with community-acquired pneumonia (CAP).~      Secondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of~     telithromycin 20 mg/kg qd for 5-7 days in children with CAP.~   "
223072|NCT00638846|"~     Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked~     (subject), daily wear, randomized, bilateral, parallel group study.~   "
223073|NCT00638833|"~     To assess the efficacy of Memantine in improving the cognitive impairment in patients with~     Multiple Sclerosis (MS)~   "
223074|NCT00638820|"~     We believe that hematopoietic stem cell transplantation (HSCT) will help subjects with~     Osteopetrosis generate functioning osteoclasts, and by so doing assist in the resolution of~     the abnormal bone architecture, and the anemia and bone marrow failure that is also~     characteristic of this disease. However, we have found in past studies that approximately 30%~     of Osteopetrosis patients do not engraft. Therefore, in this study, we plan to use a~     different combination of pre-transplant drugs to try to make transplants safer for this~     disease, as well as to provide a second infusion of stem cells in patients with matched~     related or unrelated donors. The purpose of this research is to find a safer and more~     effective means of performing stem cell transplantation in patients with Osteopetrosis, using~     chemotherapy and radiation designed to bring about engraftment and lessen transplant~     mortality.~   "
223075|NCT00638807|"~     To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee~     osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and~     ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen~   "
223076|NCT00638794|"~     Prospective, multicenter, registry of at least 11,000 (and up to 15,000) consecutive patients~     with coronary artery disease undergoing stent-assisted percutaneous coronary intervention~     (PCI) using DES without major procedural complications.~   "
223077|NCT00638781|"~     The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment~     in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within~     a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and~     tolerability of 3 doses of desmoteplase compared with placebo with special consideration of~     intracranial hemorrhage and major systemic bleedings.~   "
223078|NCT00638768|"~     The aim of this pilot study was to determine the effect of physiotherapy on impairments and~     health-related quality of life in people with a painful osteoporotic spinal fracture. It is~     hypothesised that physiotherapy will reduce impairments and improve quality of life in this~     patient group.~   "
223079|NCT00638755|"~     The purpose of this study is to evaluate the effect of nasal CO2 on nasal congestion and~     other symptoms related to Perennial Allergic Rhinitis.~   "
223080|NCT00638742|"~     To evaluate the steady-state systemic plasma concentrations of latanoprost acid following~     administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma~     or ocular hypertension.~   "
223081|NCT00638729|"~     alpha2-agonists like clonidine offer several useful effects that make these drugs an~     interesting alternative to benzodiazepines for pharmacological premedication. We therefore~     sought to determine the effect of pre-anesthetic medication with clonidine vs. midazolam in a~     randomized, double-blind, placebo controlled study. Effects of pre-anesthetic medication were~     assessed on (1) bispectral index (BIS),(2) sedation score and visual analog scales for~     anxiety and pain, (3) neuropsychologic tests to assess cognitive function and (4) circulating~     stress hormones.~   "
223082|NCT00638716|"~     This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study.~      The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment~     with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin~     monotherapy.~   "
223083|NCT00638703|"~     The main purpose of this study is to determine if Oxalobacter formigenes is effective at~     lowering urinary oxalate levels in patients with primary hyperoxaluria.~   "
223084|NCT00638690|"~     This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus~     prednisone with placebo plus prednisone in patients with metastatic castration-resistant~     prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the~     previous chemotherapies must have contained docetaxel.~   "
223085|NCT00638677|"~     Aims:~        1. To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis~          BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly~          pacifier.~        2. Test in a clinical study how feasible the method is and to study how the intervention~          affects caries occurrence.~      Main hypothesis:~      The administration of B. lactis BB12 and xylitol affects beneficially the dental health of~     the child.~   "
223158|NCT00637715|"~     Collection of the data on the safety and efficacy of the once daily administration of the~     alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract~     symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the~     course of everyday practice~   "
223219|NCT00636922|"~     The main goal of this study is to assess the safety and tolerability of RAD001 in combination~     with low-dose cytarabine in acute myeloid leukemia patients unfit for intensive chemotherapy.~     The secondary goals are to investigate the likely causes of drug response or failure.~   "
223086|NCT00638664|"~     We are seeking volunteers to participate in a research study to determine the optimal imaging~     parameters for visualization of the heart and its great vessels so that errors in computer~     data analysis is minimized and clinical accuracy is maximized.~      Participation in this study will involve having an MRI of the heart. This study will allow us~     to determine the ability to measure the volumes of your heart chambers in both the left and~     right side of your heart without using any aggressive (invasive) technique or the use of~     ionizing radiation (x-rays or gamma rays). The study will also allow us to measure changes in~     the cardiac chamber volumes during the cardiac cycle and determine whether this can be done~     rapidly and accurately. The study will also allow us to determine whether this technique can~     be used for routine clinical use.~   "
223087|NCT00638651|"~     The purpose of this study is to evaluate the efficacy of tattoo removal using topical~     imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo~     removal will be compared to a laser removal alone.~   "
223088|NCT00638638|"~     Mechanical recanalization of the culprit artery in acute myocardial infarction using stents~     provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the~     prognosis of this condition remains poor, to a large degree because of microcirculatory~     dysfunction that is observed, in near than 20 to 40 % of patients, during or following~     primary percutaneous intervention. The lack of ST-segment elevation resolution after~     angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with~     a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein~     IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with~     conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However,~     evidences are in favour of a benefit of this treatment especially when administrated early~     (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is~     to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e.~     per-angiography) administration of Abciximab on ST-segment elevation regression at one hour~     after primary percutaneous angioplasty.~   "
223089|NCT00638625|"~     The purpose of this study is to compare the features that the pathologist sees, when~     examining a lung tumor under the microscope, to the way that the tumor appears on the~     computed tomography (CT) scan. Features of the tumor may include abnormal blood vessels and~     areas in which tumor cells are dying. The samples that are taken during the needle biopsy~     contain information from one small part of the tumor. The investigators believe that they can~     show where in the tumor the samples came from, based on the CT scans during the biopsy~     procedure. If the investigators can accurately determine where in the tumor their samples~     came from, they can compare the features of that part of the tumor, as seen on the CT images,~     to the features of that part of the tumor as seen under the microscope. This research study~     also will give the investigators an idea of how much the biopsy samples are distorted in the~     process of preparing them for examination under the microscope.~   "
223090|NCT00638612|"~     The purpose of this Phase 1 study is to evaluate the safety and potential efficacy of Gene~     Mediated Cytotoxic Immunotherapy for pancreatic cancer. The approach uses an adenoviral~     vector (disabled virus) engineered to express the Herpes thymidine kinase gene (AdV-tk),~     followed by an antiherpetic prodrug, valacyclovir.~   "
223091|NCT00638599|"~     Airway management in anesthesia is critical to guarantee appropriate treatment of possible~     respiratory complications and successful operative practice. LMA® is an alternative to~     tracheal tube in some surgeries like as mastectomy on breast cancer. Given no need using~     muscular relaxants in mastectomy, the investigators hypothesized that LMA® would be a~     superior manner in airway management in radical modified mastectomy on breast cancer than the~     tracheal tube, and the LMA® might produce less influence on patients' circulatory~     homeostasis, and easier to be placed before operation.~   "
223092|NCT00638586|"~     Transradial access is a recently developed alternative for diagnostic andf interventional~     cardiac catheterization. We sought to compare the differences between patients that have~     undergone PTCA transradial and transfemoral access from the nursing point of view:~        1. Anxiety levels~        2. Pain at access point, pain in general and level of pain during mobility~        3. Differences in feelings of embarrassement~        4. Differences in satisfaction~   "
223093|NCT00638573|"~     The phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv)~     glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin~     effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly~     reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a~     primary event leading to T2DM or if it is merely a consequence of the diabetic state. To~     answer this question the investigators plan to estimate the incretin effect in 8 patients~     with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the~     incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with~     T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is~     measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose~     infusion.~   "
223094|NCT00638560|"~     The aim of the study is to compare the effects of an intensive 4 weeks exercise training~     program with or without additional treatment with antioxidants. 16 volunteers are included~     into the study and randomized into a treatment (n=8,Vitamine E 400 IU od + vitamine C 1g~     twice daily) and a non-treatment (n=8, training only) group. Before and after the training~     program, skeletal muscle biopsies will be taken to measure PGC-1alpha and PPARgamma mRNA~     expression. In addition before and after the training program individuals will have the~     following measurements: body weight, waist circumference, body fat content (DEXA scan),~     euglycemic-hyperinsulinemic clamps, ergospirometer (VO2 max), routine laboratory~     measurements, serum malondialdehyde concentrations.~   "
223095|NCT00638547|"~     This protocol will examine whether the enzyme alpha-L-iduronidase (Laronidase), delivered~     into the spinal fluid of patients with Hurler syndrome at intervals before and after bone~     marrow transplant, is a safe and effective approach to slow the neurologic degeneration seen~     in Hurler patients undergoing transplantation.~   "
223096|NCT00638534|"~     The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5~     days in children with acute otitis media (AOM).~      Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of~     telithromycin 20 mg/kg qd for 5 days in children with AOM.~   "
223097|NCT00638521|"~     Organ failure following trauma is a leading cause of morbidity and mortality. It appears that~     the development of organ failure is a direct result of an altered immune response. This~     altered response results in the production of circulating factors in the blood that causes~     direct injury to the injured patients' organs. The mechanism in which this altered immune~     response occurs is unknown. Based on work we have performed in our laboratory, we believe~     that this response is initiated on the cell membrane of particular immune cells known as~     macrophages. Although the cell membrane may appear uniform, it is not. The membrane is~     composed of specific segments that allow proteins to associate with each other forming~     receptors that are required for immune cell activation. These specific membrane components~     are composed of various lipids and cholesterol, and have been termed lipid rafts. Based on~     our laboratory work it appears that these lipid rafts can be altered following injury. In~     particular both the lipid and protein content within these raft segments may be altered~     allowing immune cells to become active leading to the production of factors that directly~     injure normal cells and organs. Thus, we plan to examine if these laboratory findings can be~     seen in patients suffering from trauma who develop clinical organ failure at Harborview~     Medical Center. If this is accomplished, this data will lead to the development of both~     prognostic and therapeutic interventions for the optimal care of injured patient~   "
223098|NCT00638508|"~     After surgery it is normal to experience some pain at the site of operation. In order to~     reduce the pain, medication such as Morphine is injected into a vein using a Patient~     Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient~     when needed. However, Morphine is an opioid drug, which can cause side effects such as~     sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid~     drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs~     (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects~     of morphine. Recently a portable device called ON-Q pump has been developed to continuously~     infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q~     Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses~     the drug through the catheters by elastic force. This pump is very safe and is attached to a~     bedside pole or the patient's hospital gown. This pump has already been approved by the FDA~     for clinical use, and has been reported to provide effective pain management after some~     surgical procedures.~      The primary aim of the present study is to evaluate the relative efficacy of the drugs~     Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following~     gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used~     for post operative pain relief. Our hypothesis is that these two drugs in combination will~     provide better analgesia than Ketorolac alone.~   "
223099|NCT00638495|"~     The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable~     pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this~     drug or placebo for 28 days in four groups with a design of randomized, double-blind,~     parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary~     metabolites are to be determined.~   "
223100|NCT00638482|"~     Intrarenal calcifications (nephrocalcinosis) is present in Dent's disease and likely~     contribute to progression toward renal failure. In order to prevent this complication it is~     usually proposed to treat affected patients during childhood with high doses of thiazides.~   "
223101|NCT00638469|"~     Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been~     approved for the treatment of moderate to severe psoriasis. However, in a portion of cases~     adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or~     greater, now being considered as gold standard for treatment efficacy. In this study we aim~     to determine in a randomized half-side comparison whether additional narrowband UVB-311nm~     phototherapy accelerates and improves the clearance of psoriatic lesions in~     adalimumab-treated patients after initial slow response.~   "
223102|NCT00638456|"~     This study is designed to evaluate whether or not oral viscous budesonide is effective in~     treating children with Eosinophilic Esophagitis.~   "
223103|NCT00638443|"~     The primary objective of the proposed pilot study is to determine the efficacy of pregabalin~     in prolonging the time to onset of pain and reducing the severity of pain associated with~     walking in patients with neurogenic claudication. Neurogenic claudication is defined as~     movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or~     both legs provoked with walking and standing and relieved by sitting, squatting, or forward~     flexion posturing. The secondary objective is to examine the functional benefit of pregabalin~     with respect to improvement in duration and distance of walking.~   "
223104|NCT00638430|"~     The purpose of this study is to examine the effect of the myopic optical defocus on the~     Humphrey Matrix 30-2 test.~   "
223105|NCT00638417|"~     The aim of the study is to improve hospital treatment and rehabilitation of patients with hip~     arthroplasty to help the patients to regain functional ability in the shortest possible time,~     and reduce hospital and rehabilitation time to save costs for the patient and society.~      Optimal reconstruction of the hip joint and the effect of an intensive physical training~     programme are compared to conventional rehabilitation programmes.~   "
223106|NCT00638404|"~     A simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity~     rating of audio tone will predict the severity of postoperative pain after surgery.~   "
223107|NCT00638391|"~     The purpose of this study is the initial/followed by 5 year adjuvant therapy with~     Anastrozole.~   "
223108|NCT00638378|"~     This is a clinical trial of orally administered Ruxolitinib (INCB018424) in patients whose~     disease has progressed following 1 prior chemotherapy regimen (not including anti-androgens~     or ketoconazole) for metastatic, androgen-independent prostate cancer.~   "
223109|NCT00638365|"~     The primary objective of this study is to evaluate the safety and tolerability of a single~     dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)~   "
223198|NCT00637195|"~     Infection with human papillomavirus (HPV) has been clearly established as the necessary cause~     of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and~     safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals'~     HPV vaccine GSK580299 in healthy female subjects.~   "
223110|NCT00638352|"~     Needle biopsy is a way of determining whether a lung mass is cancerous or benign. Its~     accuracy was established by research in which patients underwent fine needle aspiration, a~     kind of needle biopsy that yields samples for cytology (similar to the way a pap smear or a~     fluid sample would be evaluated for malignant cells). This kind of needle biopsy may~     supplemented or replaced by core needle biopsy, which yields samples for histology (similar~     to surgical tissue samples but on a smaller scale) rather than for cytology. Core needle~     biopsy is believed to be helpful particularly in obtaining a diagnosis in patients who have a~     lung mass that their doctors think is cancerous but is, in fact, benign. In spite of the~     advances in needle biopsy, however, there are patients who do receive a pathology report~     indicating no evidence of cancer but whose lung mass actually is cancerous. The fraction of~     such patients, among all patients who have no evidence of cancer according to the biopsy, is~     called the false negative rate. It is approximately 25% for needle biopsies that consist of~     fine needle aspiration alone. The false negative rate for needle biopsies that include core~     biopsy samples is not known.~      We want to examine the accuracy of needle biopsy in patients who had core samples taken from~     a lung mass in addition to, or in place of, fine needle aspiration. In this study we will~     focus on such patients who had no evidence of cancer according to the biopsy, to determine~     how many actually had a cancer that was missed by the biopsy. To accomplish this goal, we~     will need to review the medical records of these patients for one of two things: either a~     definitive diagnosis of the lung mass by some other means (for example, surgical biopsy), or~     by seeing how the patient does over a period of time (usually in conjunction with medical~     imaging tests such as chest x-rays or chest CT scans). To establish that a lung mass is~     benign by observing a patient over time, it is necessary to show that the lung mass~     disappears, becomes smaller, or remains unchanged in size for 2 years.~   "
223111|NCT00638339|"~     The purpose of this study is to monitor sleep in patients using breathing machines, because~     little is known about sleep when patients use masks to help their breathing. We'd like to~     compare sleep in patients using masks to that in patients with a tube in their throats.~   "
223112|NCT00638326|"~     The purpose of the study is to determine whether administration of 150 mg clopidogrel is~     effective in reducing the one-year incidence of thromboischemic events in patients with high~     on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous~     coronary intervention.~   "
223113|NCT00638313|"~     PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus.~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and~     glucose lowering capabilities following a single subcutaneous dose.~   "
223114|NCT00638300|"~     The study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron~     which is bound to potentially dialyzable ligands, after it's release from intravenous iron~     compound administered during hemodialysis.~   "
223115|NCT00638287|"~     The purpose of this study is to demonstrate the degree of variability in commercially~     available assays for Growth Hormone measurement in the context of clinical decision making~     for Growth Hormone (GH) deficiency and Acromegaly and to determine variability among IGF-I~     inter-assay samples obtained at the time of Growth-Hormone Releasing Hormone Arginine Testing~     and Oral Glucose Tolerance Testing.~   "
223116|NCT00638274|"~     The purpose of this study is to determine whether there is a difference in success outcome of~     the combined spinal epidural labor analgesia between air versus saline when used to identify~     the epidural space.~   "
223117|NCT00638261|"~     Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been~     approved for the treatment of moderate to severe psoriasis. However, in a portion of cases~     adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or~     greater, now being considered as gold standard for treatment efficacy. In this study we aim~     to determine in a randomized half-side comparison whether initial narrowband UVB-311nm~     phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated~     patients.~   "
223118|NCT00638248|"~     The purpose of this study was to explore trends in safety and efficacy, and to find the~     optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial~     will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy~     (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety~     (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI~     and correlating with clinical outcome) profiles gained from this study were the basis of~     planning the phase III.~   "
223119|NCT00638235|"~     1. This is a prospective, multi-center, post market study, which will be conducted under a~          common protocol.~        2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic~          Floor Repair System devices for prolapse repair.~        3. The study population is female subjects > 21 years of age who require surgical~          reconstruction of their pelvic floor due to prolapse.~        4. The clinical data will be analyzed by comparing post-treatment data with the baseline~          data, with the subject acting as her own control. The follow-up is for two years after~          the procedure.~        5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary~          endpoint of the study. The secondary endpoints include quality of life changes from~          baseline and adverse event rates.~   "
223120|NCT00638222|"~     Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives~   "
223121|NCT00638209|"~     The purpose of the study is to investigate whether insulin sensitivity of the human brain~     correlates with insulin sensitivity of the liver.~   "
223122|NCT00638196|"~     Several investigations have suggested that polyunsaturated fatty acids may promote~     therapeutic effects in MS. This pilot study will determine whether omega-6 polyunsaturated~     fatty acids (PUFAs),in the form of linoleic acid,can reduce disease activity and prevent~     disability progression in patients with relapsing MS.This study will seek to measure disease~     activity as seen on MRI scans in addition to measuring relapse rates.~   "
223123|NCT00638183|"~     Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for~     treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic~     bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey~     is conducted to collect safety and effectiveness information on the use of this product for~     long period of time in daily clinical settings, and to obtain proper drug use information.~   "
223124|NCT00638170|"~     The objective of the study is to determine whether recurrences of urinary tract infection in~     children can be prevented with cranberry juice.~   "
223125|NCT00638157|"~     multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin~     (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the~     treatment of SAIE~   "
223199|NCT00637182|"~     The purpose of this study is to look at the effect of anastrozole (ZD1033, Arimidex™) in~     reducing gynecomastia in pubertal boys treated with placebo in Trial 1033US/0006 (another~     anastrozole study).~   "
223126|NCT00638144|"~     End stage HCV-related cirrhosis has become a major indication for liver transplantation (LT).~     Unfortunately, recurrence of HCV infection on the liver graft occurs in almost all patients~     following transplantation and causes a persistent infection that leads to chronic hepatitis~     and cirrhosis in a significant proportion of patients. To date there is no effective way to~     prevent HCV reinfection of the liver graft in the early phase after transplantation. . Early~     passive immunotherapy with neutralizing antibodies against HCV should be considered for~     preventing reinfection of liver transplanted patients associated with HCV. This approach is~     well established in the case of patients undergoing liver transplantation for chronic~     hepatitis B virus infection. Our purpose is to produce neutralizing monoclonal antibodies to~     prevent reinfection of the liver graft.~   "
223127|NCT00638131|"~     There is little doubt of the necessity for further improvement in the prevention and therapy~     of end-stage renal disease. Despite the success of ARB in treating diabetic nephropathy, not~     all patients obtain satisfactory control of blood pressure, albuminuria and decline in renal~     function. Experimental data have provided us with a rationale for the potential added~     benefits of ET receptor blockade to the AII inhibition in diabetic renal protection.~     Considering the nephroprotective effect of bosentan in diabetic rats, clinical studies are~     warranted to assess whether ET receptor antagonism has additive renoprotective effects on top~     of AII inhibition.~   "
223128|NCT00638118|"~     Examine the relative potency, onset of action and duration of action of fexofenadine HCl 180~     mg (Allegra) and montelukast sodium 10 mg (Singulair) as compared to placebo on skin wheals~     and flares induced by seasonal allergen.~   "
223129|NCT00638092|"~     The purpose of this trial is to determine whether iodide supplementation of neonates born~     under 31 weeks gestation improves neurodevelopment measured at two years of age.~   "
223130|NCT00638079|"~     To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625~     mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in~     healthy individuals.~   "
223131|NCT00638066|"~     According to high rate of vaginismus (about 10 percent) which leads to unconsummated marriage~     (about 1 percent) and low efficacy for conventional treatments such as biofeedback therapy,~     analgesic drugs and pain killers and surgical treatment, there`s necessity to find more~     effective method.~      In our previous study, injecting botulinum toxin in 23 patients cured 75% of them.Now we are~     to make comparison between different doses of toxin injection and record the patient sexual~     satisfaction.~   "
223132|NCT00638053|"~     The purpose of this study is to assess the prevalence of GHD in patients who sustain a head~     injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH)~     therapy in the treatment of GHD caused by trauma or head injury~   "
223133|NCT00638040|"~     The purpose of this study is to analyze the gene expression patterns associated with various~     microenvironmental stresses in tumors to understand their roles in tumor progression and~     treatment responses. To achieve this goal, we will perform gene expression analysis of the~     tumor samples collected from an IRB-approved study (IRB #: 4516-05-2R2) International Phase~     III Study of Chemoradiotherapy versus Chemoradiotherapy Plus Hyperthermia for Locally~     Advanced Cervical Cancer directed by Dr. Mark Dewhirst. We will correlate the gene expression~     signatures of different microenvironmental stresses with the measured physiological~     parameters to understand their role in tumor progression, treatment response and clinical~     outcomes.~   "
223134|NCT00638027|"~     Participants (n=20) will be identified at routine care visits performed at the Rochester~     Multiple Sclerosis Center. Eligible participants will have MS by McDonald Criteria,7 and will~     have a modified Ashworth spasticity rating8 of two or higher in at least one lower extremity~     muscle group. Participants will be seen at screening, one, and three months, and will be~     evaluated using the modified Ashworth scale,8 pendulum test,9 toe tapping test,10 manual~     muscle testing,11 timed 25 foot walk,12 and Multiple Sclerosis Functional Composite.13 The~     type and severity of any adverse events will be recorded using standard definitions.~     Participants will be instructed to call between visits to inform the investigators regarding~     any adverse events they experience. Follow-up will continue until all adverse events resolve~     or stabilize.~   "
223135|NCT00638014|"~     The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves~     early postoperative recovery as manifested by decreased pain and improved pulmonary function.~      Secondary objectives include evaluation of Rapid Sternal Closure System with regard to SWCs~     (surgical wound complication defined as surgically treated sternal wound infection and~     sternal instability/non-union) as outlined in the protocol.~      For a given study endpoint, the null hypothesis will be no difference between the Rapid~     Sternal Closure System group and the control group. The alternative hypothesis will be a~     difference between 2 groups. The statistical objective of this study is to reject the null~     hypothesis in favor of the alternative hypothesis.~   "
223136|NCT00638001|"~     The purpose of this study intend to evaluate the effectiveness of functional orthoses~     (including custom-made insoles and shoes) for preventing and controlling repetitive~     haemarthrosis in patients suffering of haemophilic ankle arthropathy, as well as the~     orthoses' impact on foot health-related quality of life.~   "
223137|NCT00637988|"~     This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's~     metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies. The~     patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin,~     esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing~     period, whilst undergoing further follow up endoscopies and multiple biopsies.~   "
223138|NCT00637975|"~     The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in~     combination for the treatment of oncological neuropathic pain with two different strategies.~   "
223139|NCT00637962|"~     To determine the local (cervico-vaginal) and systemic (whole body) safety of vaginal~     immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.~   "
223140|NCT00637949|"~     This safety study evaluated the incidence of gastrointestinal adverse events and edema in~     patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator~   "
223215|NCT00636974|"~     To determine and compare the effective intrathecal dose of levobupivacaine, ropivacaine and~     bupivacaine for 50% of patients in lower limb surgery~   "
223216|NCT00636961|"~     This study evaluated the effect of QAB149 on dynamic and static hyperinflation,~     breathlessness, and health status in COPD patients~   "
223141|NCT00637936|"~     Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as~     opposed to normally 30%) on pulmonary gas exchange and other pulmonary complications after~     abdominal surgery.~      Background: Previous studies have shown possible beneficial effects of high perioperative~     oxygen concentration on surgical wound infection and healing, but all pulmonary effects are~     not clarified. Change in perioperative PaO2/FiO2 and shunt-fraction, measured by a gas~     rebreathing technique, can describe pulmonary oxygenation. This could add knowledge to the~     pulmonary effects of high vs. normal oxygen concentration.~      Primary hypothesis of study: Perioperative use of a 80% oxygen concentration reduces the~     PaO2/FiO2-index compared to 30% oxygen.~   "
223142|NCT00637923|"~     The purpose of this study is to determine if nitazoxanide in combination with peginterferon~     alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in~     treatment-naive patients.~   "
223143|NCT00637910|"~     The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in~     second line in wild-type EGFR tumour patients.~   "
223144|NCT00637897|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Paricalcitol may help chemotherapy drugs to kill more tumor cells by making tumor cells more~     sensitive to the drugs.~      PURPOSE: This clinical trial is studying the best dose and best way to give paricalcitol and~     to see how well it works when given together with chemotherapy in treating patients with~     metastatic breast cancer.~   "
223145|NCT00637884|"~     This is a single-center, prospective, randomized, double-blind, placebo-controlled, two-way~     crossover study. A live cat challenge model will be used for exposing subjects to Fel d1.~     Subjects who test positive for cat allergy symptoms during a priming cat exposure challenge~     will be eligible to enter the treatment phase of the study. Baseline efficacy measures will~     be obtained prior to the dispensing of study medication during both treatment periods. Cat~     challenges will be initiated 1.5 hours following treatment with study medication.~   "
223146|NCT00637871|"~     This study looks at the relationship in the dose of nolvadex and the incidence of~     gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with~     Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the~     breast tissue adverse effects without reducing the efficacy of Casodex.~   "
223147|NCT00637858|"~     Effect of different doses of tomato extract (contain Lyc-o-Mato 6% Oleoresin which Contain:~     5, 15 mg lycopene , in addition to Beta-carotene (0.15%), phytoene, and phytofluene (1%); and~     vitamin E (2%), phospholipids (15%), and phytosterols (0.6%) suspended in tomato oleoresin~     oil) compared with synthetic lycopene on blood pressure and plasma lycopene levels in never~     treated pre-hypertensive otherwise healthy subjects.~   "
223148|NCT00637845|"~     A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg~     twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD)~     with continued heartburn symptoms with a course of therapy of 30 mg twice daily Lansoprazole.~   "
223149|NCT00637832|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab~     tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming~     normal cells. Giving rituximab together with combination chemotherapy and yttrium Y 90~     ibritumomab tiuxetan may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed~     follicular non-Hodgkin lymphoma.~   "
223150|NCT00637819|"~     A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active~     disease who are refractory to cyclophosphamide~   "
223151|NCT00637806|"~     To compare the effect of megestrol acetate concentrated suspension and placebo on caloric~     intake in patients with cancer-associated anorexia.~   "
223152|NCT00637793|"~     The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of~     decreased salivary flow associated with primary or secondary Sjögren's syndrome.~      For each patient, the study includes four periods of treatment separated by a washout period~     that may range from 4 - 8 days according to patient and site discretion. Each treatment~     period includes two overnight stays in the clinic. One dose of study drug is taken during~     each treatment period~   "
223153|NCT00637780|"~     This study will characterize the steady state pharmacokinetics of sulfasalazine delayed~     release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study~     will fulfill the post approval commitment to the FDA.~   "
223154|NCT00637767|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances~     to them without harming normal cells. A stem cell transplant using stem cells from the~     patient may be able to replace blood-forming cells that were destroyed by the chemotherapy~     and radiolabeled monoclonal antibody.~      PURPOSE: This randomized phase II trial is studying how well high-dose melphalan works when~     given with or without radiolabeled monoclonal antibody in treating patients with multiple~     myeloma undergoing an autologous stem cell transplant.~   "
223155|NCT00637754|"~     The registry will obtain information to determine the safety of sports participation for~     patients with defibrillators (ICDs).~   "
223156|NCT00637741|"~     The objective of this clinical investigation is to evaluate the long-term (up to 12 months)~     outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long~     femoropopliteal lesions (TASC C & D) Is is the first time that the use of 200 mm long stents~     will be evaluated in these lesions. It is expected that the outcome of the treatment with~     this type of long stents will be better as the treatment of identical lesions lengths with~     multiple shorter stents.~   "
223157|NCT00637728|"~     Purpose of the study is to compare the effects of megestrol acetate concentrated suspension~     and placebo on caloric intake for the treatment of cancer-associated anorexia in patients~     with lung or pancreatic cancer~   "
223159|NCT00637702|"~     This is a Phase 1 study during which patients with advanced solid tumors will receive a new~     formulation of investigational study drug ARRY-334543. Patients will receive increasing doses~     of study drug in order to achieve the highest dose possible that will not cause unacceptable~     side effects. The patients will be followed to see what side effects and effectiveness the~     study drug has, if any, in treating the cancer. In addition, the effect of food on the new~     formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this~     study (Active, not recruiting).~   "
223160|NCT00637689|"~     The purpose of this study is to see if recent guidelines proposed by the National Institutes~     of Health for the diagnosis, staging, and response assessment of people with chronic GVHD can~     improve our understanding of this complication. We will accomplish our goals by studying a~     large number of people with chronic GVHD over several years using information collected from~     health care providers, patients, laboratory studies and diagnostic tests. Several transplant~     centers in the United States are collaborating on this project.~   "
223161|NCT00637676|"~     An open randomized, prospective, single center; parallel group trial to compare efficiency~     and safety of PleurX-Pleural Catheter versus standard surgical treatment in patients with~     malignant pleural effusion and partial entrapment of the lung.~   "
223162|NCT00637663|"~     This is a randomized, open-labelled, prospective 96-week study comparing the antiviral~     efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining~     lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.~   "
223163|NCT00637650|"~     The purpose of this study is to study the outcome of patients after ureteroscopy in which all~     fragments remaining after holmium laser lithotripsy were retrieved compared to those where~     small, insignificant fragments were left for spontaneous passage.~   "
223164|NCT00637637|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and~     ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It is not yet known whether external-beam radiation therapy is more effective with or~     without indinavir and ritonavir in treating patients with brain metastases.~      PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to~     see how well it works compared to external-beam radiation therapy given together with~     indinavir and ritonavir in treating patients with brain metastases.~   "
223165|NCT00637624|"~     In this study we want to investigate the efficacy of N-acetylcysteine (NAC), which is an~     anti-oxidant, in the prevention of cisplatin-induced neural toxicity, in patients treated for~     lung cancer with chemotherapy containing cisplatin.~   "
223166|NCT00637611|"~     The primary objective of this study is to determine the efficacy and onsets of action of~     single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to~     placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine~     hydrochloride 180 mg, montelukast sodium 10 mg, and placebo~   "
223167|NCT00637598|"~     The purpose is to develop digital tomosynthesis to improve the detection of breast cancers.~     The aims are optimizing digital mammography and tomosynthesis acquisition, creating~     visualization tools, prospective pilot studies to evaluate radiologist performance, and~     computer-aided detection.~   "
223168|NCT00637585|"~     To examine the relative potency, onset of action and duration of action of fexofenadine HCl~     180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and~     flares induced by histamine.~   "
223169|NCT00637572|"~     Explore weight gain in HIV-positive patients who have weight loss associated with~     AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either~     megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate~     oral suspension original formulation~   "
223170|NCT00637559|"~     This study looks the intragastric and intraesophageal pH in patients with documented~     Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three~     times daily, esomeprazole 20 mg three times daily.~   "
223171|NCT00637546|"~     Type 2 diabetes is one of the fastest growing public health problems in both developed and~     developing countries. It is estimated that the number of people with diabetes in the world~     will double in coming years, from 171 million in 2000 to 366 million in 2030.The role of~     physiotherapy in diabetic care is to reduce immobilisation effects, to maintain functional~     capacity and to minimise diabetes-related complications. The physiotherapist also has a role~     in providing advice about exercise and daily living activities. The fundamental principle of~     rehabilitation is to improve quality of life while diminishing the health care burden. By~     reducing the heightened risk of falling, the fall related injuries and the fear of falling~     one could improve quality of life in diabetic patients and reduce health care costs.~      The goal of this study is to investigate the effectiveness of gait and balance training in~     pre frail subgroup diabetes patients. Our program is based on recommendations of Robertson et~     al.(2002) and Page et al.(2002) The investigators randomly assign patients in a control group~     (no treatment) or in a treatment group. The treatment program consists of two group sessions~     per week over 12 weeks. Patients were encouraged to perform specific home exercises. After~     this 12-week program, patients were asked to continue their exercises. The effect of the~     treatment will be evaluated after the treatment program and after a 6-month follow up.~   "
223172|NCT00637533|"~     Lumbar sympathetic blocks are part of the standard of care for treating patients with~     sympathetically-maintained pain (e.g. in complex regional pain syndrome or reflex sympathetic~     dystrophy- RSD). In these patients lower extremity pain can be reduced or abolished~     temporarily by blocking sympathetic nerves by doing a lumbar sympathetic block. Patients who~     respond only transiently to sympathetic blocks often choose between potentially dangerous~     lumbar sympathetic block with neurolytic agents, surgical sympathectomy, continued severe~     refractory debilitating pain or other risky invasive surgical procedures such as spinal cord~     electrical stimulation.. It is hypothesized that Botulinum Toxin Type A (BTA) injected in a~     lumbar sympathetic block can provide extended sympathetic blockade and thus pain relief. This~     pilot study aims to see if BTA can be used safely in lower extremity sympathetic blocks, and~     might be useful in providing prolonged pain relief.~   "
223173|NCT00637520|"~     We hypothesize that insulin resistance is characteristic of nonalcoholic fatty liver disease~     as compared to age, gender, non-diabetic BMI-matched control subjects, both healthy and those~     with non-cirrhotic, non-steatotic liver disease.~   "
223174|NCT00637507|"~     The investigators have recently demonstrated the beneficial effects of combined~     high-frequency oscillation (HFO) and tracheal gas insufflation (TGI) on the respiratory~     physiology [1,2] of patients with severe acute respiratory distress syndrome (ARDS)~     (NCT00416260). Preliminary short-term survival results were also encouraging. Consequently,~     in the present clinical trial, the investigators intend to increase the size of the studied~     population, in order to evaluate the effect of HFO-TGI on survival with adequate statistical~     power. Furthermore, the investigators intend to elucidate the mechanism of the~     HFO-TGI-related physiological benefit.~   "
223175|NCT00637494|"~     Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days~     followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed~     by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in~     patients with a diagnosis of psychotic depression.~   "
223176|NCT00637481|"~     Chemoprevention is the use of certain drugs to keep cancer from forming. The use of~     atorvastatin (Lipitor) may prevent breast cancer. This randomized phase I trial is studying~     the best dose of atorvastatin in preventing breast cancer in women at increased risk for~     breast cancer.~   "
223177|NCT00637468|"~     The aim of the EAGLE Study is to compare the efficacy of conservative medical treatment and~     local intraarterial fibrinolysis in patients with central retinal artery occlusion and to~     evaluate benefit and risk for the patient of both therapies.~   "
223178|NCT00637455|"~     To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on~     computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized~     objective measure of attention, accuracy and reaction time in healthy naval flight personnel.~     Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks)~     mean change from baseline in total number of errors (commission errors + omission errors)~     between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also~     will be assessed.~   "
223179|NCT00637442|"~     Examination of the correlation between the cerebral bloodflow and the clinical change under~     treatment with Reminyl retard® and the prediction of clinical change by measuring the~     cerebral bloodflow in patients with mild to moderate Alzheimer's Disease~   "
223180|NCT00637429|"~     Human immunodeficiency virus/Hepatitis B virus (HIV/HBV) co-infections are frequently~     observed due to shared routes of transmission, with reported figures indicating 6-9% of~     HIV-infected individuals in developed countries are chronically infected with HBV. HIV~     infection impacts on the natural progression of HBV infection, increasing levels of HBV~     replication and the risk of liver-associated mortality. Liver diseases associated with HBV~     are affected by the antiviral drugs used for HIV infection (toxic side effects), the current~     immune function in the patient, by improvements in the immune system brought about by control~     of the HIV infection, and by the development of resistance to the antiviral agents used for~     both the hepatitis B and the HIV infection. Co-infection with HBV increases the risk for~     hepatotoxicity in those individuals receiving highly active antiretroviral therapy (HAART)~     for their HIV infection.~      This study will recruit patients who are co-infected with HIV and HBV, and are currently~     taking or who are about to commence HAART. The study cohort will include HIV-HBV co-infected~     individuals from the Alfred Hospital, the Royal Melbourne Hospital and high case load GP~     clinics who are referred to the Alfred Hospital.~      The aim of the study is to investigate chronic hepatitis B and its impact on the progression~     of liver disease in HIV-infected persons receiving HAART.~      This will be achieved by 6 monthly assessment with medical history, physical examination,~     bloods for markers of liver disease and hepatitis B activity and completion of questionnaires~     to measure adherence and alcohol use.~   "
223181|NCT00637416|"~     This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary~     control alone will improve pediatric hoarseness symptoms.~   "
223182|NCT00637403|"~     To determine the pharmacokinetics and safety of megestrol acetate after a single oral 300 mg~     dose of megestrol acetate concentrated suspension in healthy subjects, and subjects with~     varying degrees of renal impairment~   "
223183|NCT00637390|"~     Ovarian cancer cannot grow without recruiting new blood vessels. Studies in humans have~     identified a novel cell population, termed vascular leukocytes (VLCs). While VLCs are not~     cancer cells, they support the growth of ovarian cancer cells by stimulating the growth of~     new blood vessels which provide the cancer with nutrients. VLCs make a protein termed CD52.~     An antibody therapeutic, Alemtuzumab (also know as Campath), that kills cells that make the~     CD52 protein has been successfully used to treat certain lymphomas (a type of blood cell~     cancer) that make CD52 protein. The purpose of this study is to determine if Alemtuzumab~     given subcutaneously (under the skin)can be safely given to patients with ovarian, fallopian,~     or primary peritoneal cancers to kill VLCs and determine if Alemtuzumab, by eliminating VLCs,~     can restrict tumor growth or increase response rates to chemotherapy given after the~     discontinuation of chemotherapy.~   "
223184|NCT00637377|"~     This study is a phase III, double-masked, randomized, study of the efficacy and safety of~     VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately~     1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.~   "
223195|NCT00637234|"~     Over recent years an approach with the adjunctive administration of various anticonvulsant~     drugs has been discussed and a limited number of open and controlled studies were performed~     for carbamazepine, valproic acid, and lamotrigine. While the latter shows promising effects~     in the long run it has some handling difficulties in the acute treatment of acute psychotic~     exacerbations. Valproic acid has shown inconsistent effects in schizophrenia with no~     significant effects in a recent controlled study. Although still controversially discussed,~     carbamazepine was found to offer beneficial effects in the treatment of schizophrenia.~     Nonetheless, data on these effects are limited by small sample sizes or poor design of most~     of the respective studies. Furthermore, the complex pharmacological interactions of new~     atypical neuroleptics with carbamazepine underline the necessity of alternative strategies in~     adjuvant treatment of schizophrenia as well as in combined treatment of bipolar disorders~     with mood stabilizers and neuroleptics.~      Oxcarbazepine (OXC) is a new anticonvulsant drug that acts as a pro-drug for the~     10-monohydroxy metabolite (MHD), an active metabolite also of carbamazepine that is suggested~     to be responsible for most of its therapeutic actions. Therefore, the pharmacological action~     of OXC is very well comparable to carbamazepine whilst there are fewer unwanted side effects~     of OXC regarding eg. skin rush, and effects on blood compounds or cardiotropic effects.~      The effects of OXC on cytochrome CYP3A4 and CYP3A5 are moderate and UDPGT is only slightly~     affected by OXC, which leads to less interaction with other compounds on a pharmacokinetical~     level.~      In psychiatry, the few studies published until now report positive effects of OXC in bipolar~     disorders. With regards to our own clinical observations, OXC has shown potential beneficial~     effects as an adjunct in the treatment of schizophrenia as well that require further~     evaluation in a controlled study design.~   "
223185|NCT00637364|"~     This is an open-label, non-randomized, single-center, therapeutic trial in patients with AJCC~     Stage III or IV pancreatic cancer with tumor related abdominal and/or back pain to evaluate~     the safety of high intensity focused ultrasound therapy using the FEP-BY02 HIFU system for~     palliation of pancreatic cancer-related pain. Patients meeting all eligibility criteria~     without any exclusion criteria will be offered an opportunity to participate in the study.~     After obtaining informed consent a baseline history, physical examination, laboratory~     studies, and any additional imaging studies needed will be performed.~      The major theoretic risk to the patient with this procedure is the development of acute~     pancreatitis. If acute pancreatitis were to develop, it should become clinically evident by~     day 3 following HIFU ablation. Therefore, the initial phase of this pilot study is designed~     to allow a sufficient interval between HIFU treatments to identify whether this theoretic~     risk will manifest clinically. Previous clinical experience in China suggests that HIFU of~     pancreatic tumors is safe without risk of developing severe acute pancreatitis.~      Patients treated with HIFU will have approximately 15-20% of the tumor volume treated per~     session. The first 5 patients (feasibility study) will receive their first HIFU treatment~     followed by a 3-5 day interval for observation.~      Following the feasibility study the results will be reviewed with the FDA. If no serious~     adverse events are encountered, and the FDA agrees with continuing the study, then the next 5~     patients will be treated with an interval of 2-3 days between each treatment. If no serious~     adverse events are encountered in this group, then the next group of 5 patients will be~     treated at intervals of 1-2 days between each treatment.~   "
223186|NCT00637351|"~     GSK Biologicals is working on the development of a vaccine to protect elderly people from~     bacterial pneumonia. Diagnostic of bacterial pneumonia is difficult, and for the future~     studies in that project, it would be useful to have some easy non invasive tests. New~     clinical read-outs are needed to detect and identify the causative pathogen. These assays~     will be based on specific antigen detection in the urine or specific pathogen DNA detection~     in the blood. Technical and clinical validation of these assays will be realised at later~     stage with samples coming from epidemiological and/or phase III studies.~      To allow the development of such tests in GSK Biologicals laboratories, urine and blood~     samples are needed from subjects aged 65 or above who have diagnosed pneumonia.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
223187|NCT00637338|"~     PF-04603629 is being investigated for the treatment of Type 2 diabetes mellitus (T2DM).~     Specifically, PF-04603629 is a protein that is a combination of exendin-4 (a glucagon-like~     peptide-1 (GLP-1) mimetic currently marketed as Byetta®) fused to human transferrin (a~     naturally occuring protein) in order to increase the concentration of exendin-4 in the blood.~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of PF-04603629 following multiple escalating subcutaneous doses in adult~     subjects with T2DM.~   "
223188|NCT00637325|"~     This is an open-label, randomised phase III, multicentre, Italian study designed to~     investigate the role of trastuzumab in patients with locally advanced and/or metastatic~     breast cancer over expressing HER2 who received a first line chemotherapy containing~     trastuzumab. The trial in divided in two studies: 1. The maintenance study will be conducted~     in patients not progressing to a first line chemotherapy plus trastuzumab. 2. The 2nd line~     study will be conducted in patients progressing to a first line chemotherapy plus~     trastuzumab.~   "
223189|NCT00637312|"~     The purpose of this study is to establish the safety and effectiveness of the Advent™~     Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating~     degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following~     cervical discectomy in skeletally mature patients (at least 18 years of age).~   "
223190|NCT00637299|"~     The purpose of this trial is to verify if an osteopathic treatment added to usual pulmonary~     rehabilitation trial is able to improve the walking ability of COPD patients and if there is~     any influence on lung functionality.~   "
223191|NCT00637286|"~     The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMT™~     (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in~     treating migraine over a period of 6 months~   "
223192|NCT00637273|"~     This study will compare the benefits of exenatide once weekly treatment to those achieved by~     the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2~     diabetes is managed with metformin therapy alone. The safety and tolerability of the three~     treatment regimens will also be compared.~   "
223193|NCT00637260|"~     Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson~     disease (PD), but it is not optimally effective for controlling every motor sign and adverse~     events are not so infrequent Therefore, other approaches should be considered.We identified~     the motor cortex as a possible candidate and therefore we propose a double-blind randomized~     prospective study in 20 Parkinson patients in order:~        -  to test the efficacy of epidural motor cortex stimulation in Parkinson disease (primary~          endpoint: UPDRS III at 12 months at the end of the cross-over)~        -  to find out optimal electrode position and optimal stimulation parameters~   "
223194|NCT00637247|"~     The purpose of this study is to determine if imexon in combination with gemcitabine could~     improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer~     that has spread to other organs such as the liver or lungs. The study will also look at the~     safety of the combination as compared to gemcitabine alone. Participants in the study will be~     randomly assigned to either treatment and neither the participant or their doctors will know~     which treatment they will be receiving.~   "
223196|NCT00637221|"~     This is an open label exploratory study to investigate the safety and effects of a single~     dose of NPL-2009(50 mg - 150 mg) on Prepulse Inhibition (PPI) Tests and Continuous~     Performance Tasks (CPT) in adults with Fragile X Syndrome~   "
223197|NCT00637208|"~     Patients with varicocele in whon early prostate cancer will be found will undergo venographic~     embolization of both spermatic veins. The study hypothesis is that this procedure will induce~     a gradual regression of the prostate volume that may decrease prostate cancer cells. Close~     follow-up will ensure that necessary therapy will be provided if needed according to clinical~     criteria. Results in terms of prostate size PSA level and tumor size will be recorded.~   "
224631|NCT00618176|"~     The purpose of this study is to determine whether the three generic nevirapine-based~     antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome~     .~   "
223200|NCT00637169|"~     Study Question: In infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does~     lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by~     pulse oximetry (SpO2)of 85-89% compared with 91-95%, from the day of birth until the baby's~     first discharge home, increase the probability of survival without severe neurosensory~     disability to a corrected age of 18 months?~   "
223201|NCT00637156|"~     The purpose of this clinical investigation is to assess the safety and effectiveness of using~     the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc~     disease at two adjacent levels of the cervical spine, with overall success being the primary~     endpoint of the clinical trial. The primary objective is to show non-inferiority of the~     investigational device to the control treatment. If non-inferiority is established,~     superiority will also be examined as the secondary objective.~   "
223202|NCT00637143|"~     The purpose of this study is to compare renal transplant recipients on cyclosporine~     maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to~     renal outcomes.~   "
223203|NCT00637130|"~     The purpose of this study is to compare the safety and IOP-lowering efficacy of various low~     dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.~   "
223204|NCT00637117|"~     The purpose of the study is to gather data on feasibility and on immune and clinical efficacy~     of intratumoral dendritic cell (DC) vaccination in combination with local radiotherapy in~     patients with recurrent lymphoma~   "
223205|NCT00637104|"~     The main objective of this study is to assess the safety and effectiveness of the TiN-coated~     MAR-Tyn stent in maintaining minimum lumen diameter in de novo native coronary artery lesions~     as compared to an uncoated control cobalt-chromium balloon-expandable stent (Vision, Abbott~     Vascular). Both stents are mounted on a Rapid Exchange Stent Delivery System.~   "
223206|NCT00637091|"~     The purpose of this study is to investigate the response rate of cetuximab plus irinotecan~     every 2 weeks in patients harboring wild-type KRAS with and without detectable~     EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.~   "
223207|NCT00637078|"~     The objective of this study is to assess if the implementation of a treatment algorithm~     including initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination and~     subsequently a low dose DHP-CCB/statin combination will improve the management of~     hypertension/hypercholesterolemia compared to guidelines-base management at family practices.~   "
223208|NCT00637065|"~     Over time, patients with fibrosing or interstitial lung disease (ILD) can develop high lung~     blood pressures (pulmonary hypertension), and this is associated with poorer prognosis and~     survival. It is thought that development of PH contributes to the deterioration and death of~     patients with ILD. Endothelin-1 (ET1) is a substance contributing to the development of both~     PH and ILD. Bosentan is a drug blocking the action of ET-1 by binding to its receptors.~     Bosentan clearly benefits patients with PH of unknown cause, or related to other diseases~     (such as heart conditions, or HIV) both alone and in combination with other treatments. In~     patients with fibrosing lung disease and PH, there have been no controlled treatment studies.~     Clearly it is important to evaluate the effectiveness of bosentan in these patients.~      This study aims to determine the ability of bosentan to reduce high blood pressure in the~     lungs (pulmonary hypertension) in patients with scarring (fibrosing) lung disease. It is a~     placebo-controlled double blinded study for 16 weeks (and it is proposed to follow patients~     in a 16 week open-label phase with bosentan therapy).~   "
223209|NCT00637052|"~     This is a 2-phase study during which patients with select myeloid leukemias or advanced~     myelodysplastic syndrome (MDS), who have failed, refused or are not eligible for standard~     treatment, will receive investigational study drug ARRY-520.~      The study has 3 parts. The first phase of the study, Phase 1, has 2 parts. In the first part~     of Phase 1, patients with select myeloid leukemias or advanced MDS will receive increasing~     doses of study drug on different schedules in order to achieve the highest dose possible that~     will not cause unacceptable side effects. Approximately 30 patients (per schedule) from the~     US will be enrolled in Part 1 (Completed). In the second part of Phase 1, patients with~     advanced MDS will receive the best dose of study drug and schedule determined from the first~     part of the study. Approximately 10 patients from the US will be enrolled in Part 2~     (Completed).~      In the third part of the study, Phase 2, patients with acute myeloid leukemia (AML) or~     advanced MDS will receive the best dose of study drug and schedule determined from the first~     part of the study and will be followed to see what side effects the study drug causes and to~     see what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from~     the US will be enrolled in Part 3 (Withdrawn).~   "
223210|NCT00637039|"~     The main purpose of this study is to explore the safety and tolerability of multiple~     ascending doses (MAD) of AZD8931 in patients with advanced solid malignancies~   "
223211|NCT00637026|"~     A pre-surgery study to assess changes that occur in human breast cancer material and normal~     skin after a short course of treatment with Iressa.~   "
223212|NCT00637013|"~     The study aims at determining the effectiveness and cost-effectiveness of surgical management~     of subacromial impingement (including partial tears) compared to conservative treatment. The~     research setting is prospective, randomised, and controlled.~      The aim of the study is to search out evidence based data of indications for subacromial~     decompression. The investigators also aim at offering patients the most efficient and~     effective treatment and reduce the number of operations that do not have sufficient~     effectiveness. The data obtained will facilitate developing guidelines for referrals to a~     specialist when subacromial impingement is suspected.~      The investigators hypothesise that there are subgroups of patients suffering from subacromial~     impingement that benefit from surgery whereas other subgroups are best treated~     conservatively.~   "
223213|NCT00637000|"~     The purpose of this study is to compare the presence, degree, time course and profile of~     opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine~     or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome~     measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal~     Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate~     an opioid withdrawal syndrome.~   "
223214|NCT00636987|"~     The purpose of this study is to further evaluate the long-term safety and effectiveness of~     the Biocor and Biocor Supra Valves.~   "
223220|NCT00636909|"~     The purpose of this study is to provide allogeneic stem cell transplantation to patients who~     have not traditionally undergone this procedure because of it high incidence of treatment~     related side effects. We hope to decrease these side effects by decreasing the chemotherapy~     dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone~     marrow is not completely eliminated) and by using donated stem cells to treat cancer of the~     blood.~   "
223221|NCT00636896|"~     This study is designed as a 3 week, randomized, double blind, placebo controlled, trial.~     Olanzapine and modafinil will be titrated to 10mg and 200mg respectively. Feeding lab~     assessments will be conducted at baseline and endpoint. Assessments of hunger/satiety,~     kilocalories consumed and weight will be obtained. Plasma ghrelin and PYY3-36 levels will be~     drawn at baseline and endpoint prior to breakfast and two hours post.~      Study hypothesis: The modafinil/olanzapine group will gain less weight than the~     olanzapine/placebo group over three weeks of drug intake.~   "
223222|NCT00636883|"~     The purpose of this study is to determine if the combination of Gemcitabine, Oxaliplatin and~     Erlotinib in the treatment of patients with pancreatic cancer will provide increased clinical~     benefits and improvement in their quality of life.~   "
223223|NCT00636870|"~     To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and~     fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of~     desloratadine compared to fexofenadine following single and multiple oral doses administered~     to desloratadine slow metabolizers.~   "
223224|NCT00636857|"~     The proposed study will focus on anesthesia and anesthesia-induced hypotension as a possible~     cause for postoperative fluid retention and hyponatremia, and investigate gender differences~     in this response.~   "
223225|NCT00636844|"~     To identify patients that are at risk of heart damage after receiving chemotherapy~     (adriamycin).~   "
223226|NCT00636831|"~     The purpose of this study is to determine whether prophylactic antibiotic use in inguinal~     hernioplasty are effective in prevention of infectious complication.~   "
223227|NCT00636818|"~     The primary objective of this clinical study is to assess overall safety and tolerability as~     measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation~     to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of~     Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity~     Disorder (ADHD).~   "
223228|NCT00636805|"~     1. Primary Objective:~             -  To determine the efficacy and tolerability of palonosetron and dexamethasone in~               preventing acute CINV in brain tumor patients during the first 24 hours of~               receiving Irinotecan /Bevacizumab regimens.~        2. Secondary Objective~             -  To determine the safety and tolerability of palonosetron in brain tumor patients.~             -  To determine the effects of glucocorticoid and anticonvulsants on the efficacy of~               palonosetron.~             -  To determine the efficacy of palonosetron and dexamethasone in preventing delayed~               CINV in brain tumor patients during days 2-5.~             -  To determine if patients receiving palonosetron have less fatigue than baseline.~   "
223229|NCT00636792|"~     This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and~     safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed~     or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects~     may be sensitive or refractory to prior therapies, including rituximab.~   "
223230|NCT00636779|"~     The Bravewell Integrative Medicine Research Network (BraveNet) is a newly formed~     practice-based research network of nine leading integrative medicine centers around the U.S.~     collaborating in clinical outcomes research to increase the knowledge and evidence-base of~     integrative medicine.~   "
223231|NCT00636766|"~     The aim of the present study is to examine the atherosclerotic plaque stability using in vivo~     and in vitro techniques and to investigate the influence of exercise, anti-diabetic,~     lipid-lowering and cannabinoids receptor antagonists on atherosclerotic plaque texture in~     patients with cardiovascular risk and animals prone to atherosclerosis.~   "
223232|NCT00636753|"~     The purpose of the study is to determine whether antipsychotic treatment is influence~     psychiatric patients due to endocrine and metabolic status and quality of life.~   "
223233|NCT00636740|"~     The objective of MER-101-03 is to examine the effects of two different dosing regimens of~     MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be~     monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be~     enrolled will be those who have not received any previous bisphosphonate therapy. The study~     will be carried out on prostate cancer patients who are no longer on hormone therapy.~     Treatment in the study will be for a 2-month period.~   "
223234|NCT00636727|"~     Many patients suffer from a disorder known as temporomandibular joint dysfunction. This~     disorder has jaw joint pain and limited function as key elements. Many treatments have been~     advocated over the last 40 years, many of them deleterious. Currently treatment can be~     divided into four categories. The first is non-surgical and involves vocal rest, soft diet,~     heat, anti-inflammatory medications, muscle relaxants, splint therapy and physical therapy.~     All patients benefit to some degree utilizing one or more non-surgical approaches.~     Controversy exists with respect to which of the next three categories of treatment is ideal.~     Some advocate arthrocentesis which involves placing two small needles into the joint to allow~     irrigation and instillation of anti-inflammatory medication. This is a minimally invasive~     procedure performed under local anesthetic alone or with intravenous sedation. Others~     advocate arthroscopy which involves placing an arthroscope (a thin tube about 2mm in diameter~     with optical elements allowing one to see inside a joint) to visualize the inside of a joint.~     Furthermore the joint can be irrigated, scar bands removed, ligaments stretched and~     medication instilled. This is performed under a general anesthesia. Depending on the study,~     success for both arthrocentesis and arthroscopy has been reported to be about 80-90%. Still~     there are others who recommend arthroplasty which is an open joint surgical procedure that~     allows the surgeon to enter the joint and directly repair or remove the damaged cartilage~     disc within the joint. This is performed under a general anesthesia. Similar success rates of~     80-94% have been reported. It is clear that some patients only require arthrocentesis, others~     arthroscopy and others arthroplasty. We currently do not have any real mechanism of~     predicting which patients will benefit the most from which procedure.~      This study will enable patients undergoing each procedure to be followed closely with the~     hope that we can determine objective factors that will allow us to stratify patients into one~     of the three surgical options: arthrocentesis, arthroscopy or arthroplasty. Our current~     approach is empiric and typically proceeds from arthrocentesis to arthroscopy to~     arthroplasty. All patients in this study will be offered the opportunity to have~     arthrocentesis performed. It is anticipated that a minority will achieve long-term benefit in~     terms of pain and function. We hope to be able to identify those factors which will predict~     which patients will benefit so that future patients selected to have arthrocentesis will have~     much higher success rates. Patients who fail to improve with arthrocentesis or who initially~     decline that procedure will be offered the opportunity to undergo arthroscopy. It is~     anticipated that a majority of patients will achieve long-term benefit in terms of pain and~     function. Again it is hoped that we can identify those factors which will predict which~     patients will benefit so that future patients selected to have arthroscopy will have even~     higher success rates. Patients who fail to improve with arthroscopy or who initially decline~     both arthrocentesis and arthroscopy will be offered the opportunity to undergo arthroplasty~     provided that clinical and radiographic evidence exists to support the presence of either a~     diseased or displaced cartilage disc.~      Our ability to adequately treat patients with temporomandibular joint dysfunction will be~     significantly improved if we can better stratify patients and follow an evidence based~     surgical algorithm that provides the greatest opportunity for success while reducing~     potential complications. Each of these surgical procedures is the standard of care throughout~     the USA but unfortunately the choice of which procedure to perform is often empiric and~     guided more by training and surgical experience.~   "
223235|NCT00636714|"~     There is current evidence that maintaining ICU patient's blood sugar between 4.4-6.1 saves~     lives. However, this is difficult to do in the ICU and carries risks of lowering the blood~     sugar too much. In addition, the best way to achieve this control is not known. Many strict~     nomograms that provide a standardized approach for nurses have been developed and validated,~     including one here at SMH. However, these nomograms cannot apply to all patients at all~     times, especially ICU patients whose needs are rapidly changing. ICU nurses are at the~     bedside constantly, are very familiar with their patient's needs, and have decades of~     experience in titrating medication doses without a nomogram to achieve a pre-determined~     response (i.e. medications to achieve pre-selected blood pressure). Indeed, once the bedside~     nurse has bought into the importance of the concept of tight glucose control and have been~     introduced to the nomogram here at SMH, their experience and intuition may be more adaptable~     to the changing needs of the patient than an inflexible paper nomogram. This study will~     compare glucose control using our current standard nomogram versus no nomogram (i.e. nurse~     directed) in order to determine whether the nomogram should continue to be used.~   "
223236|NCT00636701|"~     We hope to understand the properties of the motor cortex in the brain of people with stroke~     using non-invasive magnetic stimulation.~   "
223251|NCT00636493|"~     Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is~     effective in the treatment of retinal vein occlusion that has caused persistent macular edema~     and decreased visual acuity.~      Hypothesis: A fluocinolone acetonide sustained drug delivery implant will be a safe and~     effective method to treat patients with macular edema and decreased vision from retinal vein~     occlusion.~   "
223237|NCT00636688|"~     Healthy lifestyle factors are associated with maintenance of erectile function in men. To~     determine the effect of weight loss and increased physical activity on erectile and~     endothelial functions in obese men.~      Randomized, single-blind trial of 110 obese men without diabetes, hypertension, or~     hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or~     less on the International Index of Erectile Function (IIEF).~      The 55 men randomly assigned to the intervention group received detailed advice about how to~     achieve a loss of 10% or more in their total body weight by reducing caloric intake and~     increasing their level of physical activity. Men in the control group (n = 55) were given~     general information about healthy food choices and exercise.~   "
223238|NCT00636675|"~     Clinical trials have identified interventions that reduce adverse outcomes such as falls in~     nursing home (NH) residents but attempts to translate these into practice quality improvement~     (QI) techniques have not been successful. Using a complexity science framework, our previous~     RO1 showed that low connection, information flow, and cognitive diversity among NH staff~     explains quality of care for complex problems such as falls. Our pilot of Connect, a~     multi-component intervention that encourages staff to engage in network-building and use~     simple strategies to make new connections with others, enhance information flow, and use~     cognitive diversity, suggests that staff can improve the density and quality of their~     interactions. This 5-year study uses a prospective, cluster-randomized, outcome assessment~     blinded design, with NHs (n=16) randomized to either Connect and a falls QI program (Connect~     + Falls) or QI alone (Falls). About 800 residents and 576 staff will participate. Specific~     aims are to, in nursing homes: 1) Compare the impact of the Connect intervention plus a falls~     reduction QI intervention (Connect+Falls) to a falls reduction QI intervention (Falls) on~     fall risk reduction indicators (orthostatic blood pressure, sensory impairment, footwear~     appropriateness, gait; assistive device; toileting needs, environment, and psychotropic~     medication); 2) Compare the impact of Connect+Falls to Falls alone on fall rates and~     injurious falls, and determine whether these are mediated by the change in fall risk~     reduction indicators; 3) Compare the impact of Connect+Falls to Falls alone on complexity~     science measures (communication, participation in decision making, local interactions, safety~     climate, staff perceptions of quality) and determine whether these mediate the impact on fall~     risk reduction indicators and fall rates and injurious falls. Cross-sectional observations of~     complexity science measures are taken at baseline, at 3 months, at 6 months, and at 9 months.~     Resident fall risk reduction indicators, fall rates, and injurious falls are measured for the~     6 months prior to the first intervention and the 6 months after the final intervention is~     completed. Analysis will use a 3-level mixed model to account for the complex nesting of~     patients and staff within nursing homes, and to control for covariates associated with fall~     risk, including baseline facility fall rates and staff turnover rates.~   "
223239|NCT00636662|"~     The purpose of this clinical study is to obtain clearance for the nasal swab sample type by~     demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory~     culture for Influenza A and B viruses using nasal swab samples.~   "
223240|NCT00636649|"~     Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night,~     sleep disturbance and morning anorexia. This 12-week study examines the effect of~     escitalopram on symptoms of NES.~   "
223241|NCT00636636|"~     Gabapentin and pregabalin are treatments for some types of neuropathic pain, including~     postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a~     day for effective pain control. The purpose of this study is to determine whether a new~     gabapentin tablet, which only needs to be taken once a day, is safe and effective for the~     treatment of postherpetic neuralgia.~   "
223242|NCT00636623|"~     The present study was designed to analyse and compare the effects of Pilates exercises and~     connective tissue massage in terms of pain intensity, pain pressure threshold and tolerance,~     anxiety, progress, and health related quality of life in females with fibromyalgia (FM)~   "
223243|NCT00636610|"~     This was a randomized, placebo-controlled, double-blind study of vismodegib (GDC-0449) added~     to biochemotherapy standard-of-care regimens for metastatic colorectal cancer (CRC), with~     treatment until disease progression. Patients received either FOLFOX (FOL=leucovorin calcium~     [folinic acid], F=fluorouracil, OX=oxaliplatin) or FOLFIRI (FOL=leucovorin calcium [folinic~     acid] F=fluorouracil, IRI=irinotecan hydrochloride) chemotherapy with bevacizumab. The~     decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and~     patient. Patients were randomized to receive vismodegib or placebo and were stratified based~     on the chemotherapy regimen chosen and whether or not Response Evaluation Criteria in Solid~     Tumors (RECIST) measurable disease was present at baseline.~   "
223244|NCT00636597|"~     This study is a prospective evaluation of patients with occult (hidden) GI bleeding without~     iron deficiency. Such patients usually undergo a diagnostic colonoscopy as a standard of~     care. The study is aimed to determine any UGI-source of occult bleeding and to correlate UGI~     symptoms with findings. Therefore, EGD is being offered to such patients as part of research.~     We proposed to enroll 200 consecutive patients referred to our GI-unit for expedited~     diagnostic colonoscopy for positive FOBT.~   "
223245|NCT00636584|"~     Whether use of SNP during cardiac surgery has any effect on thyroid function has not yet been~     investigated in humans. The aim of this study was to investigate the effects of SNP~     administration during the rewarming period of cardiac operations on circulating levels of~     thyroid hormones.~   "
223246|NCT00636571|"~     Primary Objective: To examine the effects of an exercise training program on cardiopulmonary~     fitness in early-stage postoperative non-small cell lung cancer patients undergoing adjuvant~     chemotherapy~      Secondary Objectives:~      Determine patients' adherence levels to such a program during adjuvant chemotherapy Explore~     the effects of exercise training on treatment compliance and toxicity, and quality of life.~      To explore the effects of exercise training on markers of inflammation (e.g., c-reactive~     protein, immune response) in patients undergoing adjuvant chemotherapy for early-stage~     non-small cell lung cancer~   "
223247|NCT00636558|"~     Coxsackie A21 (CVA21) virus is to be administered by IV infusion to patients with Stage 4~     melanoma, prostate and breast cancer. This is a dose escalation, safety study.~   "
223248|NCT00636545|"~     The primary objective is to determine the safety and maximum tolerated dose (MTD) of~     Genasense administered as a 2-hour intravenous infusion once weekly (Part 1) and twice weekly~     (Part 2) to patients with solid tumors.~   "
223249|NCT00636519|"~     The primary purpose of this study is:~        1. To evaluate the model determined by the ability of botulism antitoxin (bivalent,~          Aventis) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model of muscle~          paralysis in Stage A.~        2. To assess the ability of botulism antitoxin (heptavalent, Cangene) to neutralize~          Botulinum toxin in the Extensor Digitorum Brevis model of muscle paralysis in Stage B.~   "
223250|NCT00636506|"~     The purpose of this study is to assess the American Medical System's IPP 2005 inflatable~     penile prosthesis implant in subjects receiving the implant for erectile dysfunction for ease~     of patient operability and use, as well as ease of surgery for the physician.~   "
223252|NCT00636480|"~     Determine the antimicrobial properties of a proposed new product and an already approved~     product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.~   "
223253|NCT00636467|"~     The purpose of this study is to evaluate the quality criteria of the SLN detection technique~     in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters~     (rate of false negatives, rate of detection).~      Eligible patients will only be registered (no randomization). The estimated inclusion period~     is approximately 24 months. The duration of the research is 25 months (24 months for patient~     inclusion + 1 month for reception of results). The maximum participation duration of each~     patient is 1 month.~      The number of patients required in this multicentric and prospective study is 240 (16~     participating centers).~   "
223254|NCT00636454|"~     Osteoarthritis (OA) is the leading cause of disability in the United States. Studies have~     shown that training patients to cope with pain improves physical and social functioning,~     increases self-efficacy, and reduces psychological distress. However, this type of training~     is not available to the vast majority of OA patients. This study will determine the~     effectiveness of a training program for coping with pain that will be administered in~     community medical practices.~      A THIRD ARM OF THE TRIAL WAS FUNDED 09/09. TREATED PATIENTS WILL BE RANDOMIZED TO (1)A~     4-MONTH COMPUTER-DRIVEN TELEPHONE PROGRAM TO ENHANCE MAINTANENCE OF TREATMENT GAINS OR~     (2)USUAL CARE. THIS ARM WILL ONLY BE CONDUCTED AT THE STONY BROOK SITE.~   "
223255|NCT00636441|"~     This multi-center randomized Phase II study assigned HER2-negative early-stage breast cancer~     patients to receive preoperative systemic chemotherapy in either a genomic-guided arm or a~     non-guided arm. The genomic-guided method (Arm 1) used genomic expression profiling to~     assign the preoperative therapy (Doxorubicin/Cyclophosphamide (AC) versus~     Docetaxel/Cyclophosphamide (TC), while Arm 2 used random assignment to these two therapies.~   "
223256|NCT00636428|"~     The objective of our study was to compare the safety and efficacy of oral midazolam during~     pediatric endoscopy.~   "
223257|NCT00636415|"~     CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of~     elderly people. The aim of the present study was to compare the analgesic effect of~     intra-articular bupivacaine and morphine in patients with knee osteoarthritis.~      DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São~     Paulo Federal University.~      METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3~     on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine~     diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml)~     0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee~     flexion and extension angles were measured after administration of the drugs at rest and~     during movement. The total amount of analgesic complementation with 500 mg paracetamol was~     also determined.~   "
223258|NCT00636402|"~     This study was planned to compare vessel sealing system tonsillectomy (VSST) to the~     traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding,~     operative time, postoperative pain and hemorrhage.~   "
223259|NCT00636389|"~     The Polyflux HD-C4 (Gambro Renal Products) is a new dialyzer based on the existing Polyflux H~     membrane and dialyzer technology, but which achieves a performance comparable to Polyflux~     210H in a significantly smaller device.~      The objectives of this study are:~        1. To compare and contrast small and large molecule removal by the Polyflux HD-C4 and~          Polyflux 210H dialyzers under conditions of routine hemodialysis; and,~        2. To compare and contrast the ease of use of the Polyflux HD-C4 dialyzer with that of the~          Polyflux 210H under conditions of routine clinical use for hemodialysis.~   "
223260|NCT00636376|"~     Head injury is the most common cause of mortality and acquired disability in childhood. It is~     common to elevate the head of patients at risk for increased intracranial pressure, although~     it is not clear if it is always beneficial. Every severe pediatric traumatic brain injured~     patient will have an optimal head position that prevents rising pressure in the brain.~   "
223261|NCT00636363|"~     To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba~     vision Aquify Multipurpose solution~   "
223262|NCT00636350|"~     - list item one, Peppers~      We propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or~     non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. The specific~     aims of this study are: 1) to determine blood response kinetics of lutein following multiple~     doses of non-pungent green jalapeno pepper with meals. 2) to determine blood response~     kinetics of zeaxanthin/capsanthin following multiple doses of red bell pepper with meals. We~     will feed 16 healthy man and women (50 - 65 y, females were at least one year post~     menopause), each cooked green jalapeno pepper or red pepper for 4 days and donate blood~     samples up to 21 days to determine blood response kinetics of xanthophylls following multiple~     doses of pepper dishes.~   "
223263|NCT00636337|"~     Specific Aim 1: To assess the feasibility and acceptability of a home-based, computerized~     cognitive training program with survivors of central nervous system-impacting pediatric~     cancer (e.g. acute lymphoblastic leukemia, brain tumors).~      Specific Aim 2: To estimate the effect size of this cognitive training program on measures of~     attention and working memory in survivors of childhood cancer in order to determine whether a~     larger-scale clinical trial is warranted.~   "
223264|NCT00636324|"~     Despite widely used of nasal CPAP in preterm infants, uncertainties regarding aspects of its~     application remain. Clinical indications vary greatly between institutions, especially when~     combined with varieties of systems, devices, and techniques available. One of the~     controversial aspects that needs to be clarified is the level of pressure which should be~     used. The objective of the study is to compare the effectiveness of two ranges of nCPAP~     pressure that are within the spectrum of current practice for post-extubation support in very~     preterm infants.~   "
223265|NCT00636311|"~     The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV~     combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory~     Hodgkin's lymphoma increases the rate of complete remission (PET negativity) at~     transplantation.~   "
223266|NCT00636298|"~     The purpose of this study is to test the drug bevacizumab in combination with cetuximab.~     Because this combination has not been tested in cancer patients before, results will be~     analyzed to see what effects the combination of bevacizumab with cetuximab has on esophageal~     cancer.~   "
223330|NCT00635453|"~     A cluster randomized field trial to evaluate the impact that training healthcare workers in~     healthy feeding practices has on the nutrition and health of children.~   "
223267|NCT00636285|"~     The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110~     in a small number of healthy adult volunteers. Following the demonstration of safety in~     adults, this anti-Staphylococcal monoclonal antibody will then be evaluated in the target~     population of hospitalized low birth weight neonates.~   "
223268|NCT00636272|"~     Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active~     ongoing source of updated information on the long-term reliability and performance of BSC~     commercially available leads and LATITUDE-enabled (wireless or wanded) pulse generators~     (PGs).~   "
223269|NCT00636259|"~     This study provides compassionate use of bicalutamide (Casodex) at a 150-mg dose for subjects~     with prostate cancer prior to it becoming commercially available. The patient will receive~     bicalutamide 150-mg as long as the physician feels that the subject is benefiting from this~     therapy and safety information is provided regularly to AstraZeneca. Treatment will be~     discontinued after bicalutamide 150-mg becomes commercially available.~   "
223270|NCT00636246|"~     This study was designed to determine if the novel combination of the SSRI, sertraline, and~     the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable~     safety profile of SSRIs.~   "
223271|NCT00636233|"~     The goal of this research study is to discover the genetic and environmental factors that~     contribute to the cause of neural tube defects such as spina bifida and anencephaly.~     Ultimately, this type of research may result in improved diagnosis, improved treatment and~     possibly prevention.~   "
223272|NCT00636220|"~     This protocol is intended to test the feasibility of using the HIV 1/2 STAT-PAK and the DPP~     HIV 1/2 test (with and without the DPP Handheld Reader) to detect HIV antibodies in oral~     fluids.~   "
223273|NCT00636207|"~     A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast~     (MK-0476) in participants with mild or moderate asthma.~   "
223274|NCT00636194|"~     To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to~     Alcon OptiFree Replenish Multipurpose Solution~   "
223275|NCT00636181|"~     Six month at home positive pressure therapy study; which mode of therapy will lead to better~     adherence and patient outcomes?~   "
223276|NCT00636168|"~     The purpose of the study is to determine if ipilimumab is effective in preventing or delaying~     recurrence and prolongs survival after complete resection of high risk stage III melanoma~   "
223277|NCT00636155|"~     The purpose of this research study is to see if the investigational drug EL625, when combined~     with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide), is effective in~     Persistent Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)~   "
223278|NCT00636142|"~     The aim of the study is to test whether neutralizing TNF-alpha with infliximab affects~     insulin resistance and phenotypical manifestations of the metabolic syndrome as fasting~     plasma insulin, total body fat, plasma lipid profile or vascular endothelial function in~     obese male subjects.~   "
223279|NCT00636129|"~     We are looking at the effects of Stress Management and Relaxation Response training on stress~     hormones (like adrenalin and cortisol), immune function and physiology (heart rate, breathing~     rate, muscle tension).~   "
223280|NCT00636116|"~     The purpose of this study is to establish if F(ab)2 antivenom (Anavip) is safe for crotalinae~     envenomation. Confirm its effectiveness in preventing the occurrence of delayed~     coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients~     with Crotalinae envenomation.~   "
223281|NCT00636103|"~     Asthma is a long-term disease process with genetic, allergic, environmental, infectious,~     emotional and dietary influences. The symptoms control are mainly using an inhaled drug,~     avoiding triggers or taking preventive medicine. Although side effects are unlikely at low~     dose of the asthma treatment, they have become apparent at the higher dose. Due to safety~     concern, parents often turn to complementary and alternative medicine which they believe is~     natural and safe and may help to reduce the conventional medication dosage.~      There are number of reports that treatment with traditional Chinese herbs or formulas~     resulted in significant improvement in lung function and reduction in the airway~     hyper-reactivity reaction. Our study drug CUF2, was based on a classical formulae and had~     been proven to have anti-inflammatory and immunomodulatory activities in laboratory and~     animal studies.~      With the pre-clinical evidence, this study aims to determine the effect of CUF2 on improving~     the clinical symptoms, biochemical markers, and requirement of steroid dosage among children~     with asthma.~   "
223282|NCT00636090|"~     The purpose of this study is to look at the genetic changes that RAD001 causes in prostate~     cancer cells and how those changes relate to patients' response to RAD001 treatment.~   "
223283|NCT00636077|"~     The purposes of this study are to determine if the performance of a dialyzer depends on how~     tightly the hollow fiber membranes are packed in the housing of the dialyzer (the membrane~     packing density) and if that dependence is a function of the dialysate flow rate. The study~     will examine how efficiently three different sized molecules pass through a dialyzer membrane~     at different dialysate flow rates in dialyzers with different membrane packing densities.~     Transfer of urea, phosphorus and beta-2-microglobulin from blood to dialysate will be~     measured during clinical hemodialysis using four different dialyzers, each used at three~     different dialysate flow rates. The data derived from these measurements may provide insight~     into the importance of membrane packing density as a design parameter for hemodialyzers and~     if changing the membrane packing density might provide equivalent performance at a lower~     dialysate flow rate.~   "
223284|NCT00636064|"~     The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib~     therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass~     surgery~   "
223331|NCT00635440|"~     Skeletal muscle atrophy is associated with catabolic conditions such as major surgical~     interventions and leads to reduced muscle strength, increased clinical complications and~     prolonged convalescence. Several studies revealed immobilisation as a major stimulus for~     muscle wasting in severely ill patients. This study investigates the potency of neuromuscular~     electrical stimulation on skeletal muscle growth factors and degradation processes in major~     abdominal surgery patients.~   "
223332|NCT00635427|"~     The purpose of this study is to evaluate the long-term safety of every other week dosing of~     Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in~     patients with type 1 Gaucher disease.~   "
223285|NCT00636051|"~     The purpose of this study is to evaluate the effectiveness of the introduction of an EBP text~     for Nursing Research Council (NRC) members to use with RN staff to increase staff belief in,~     knowledge of and implementation of EBP in providing patient care. The theory that will drive~     this study is Disciplined Clinical Inquiry (DCI).~      The current study will use a quasi-experimental design plus DCI to engage unit RN staff in~     deciding how they might learn about EBP in a feasible, useful way. After collection of~     baseline data, the NRC member will introduce the text + solicit staff input into a plan for~     using the text to increase understanding of EBP and use of evidence to make practice changes~     on her/his own unit. Another unit in that service line or under the same Service Line~     Administrator will serve as a comparison unit. Data collection will be conducted again after~     4 and 12 weeks. At the 12 week point, the NRC member will introduce the text + solicit staff~     input for a plan on the comparison unit. Data collection will be conducted on the comparison~     unit at 16 weeks, and again on both units at 24 weeks. At the 24 week point, additional units~     will be added and the process repeated until all units represented on the NRC have been~     included.~      Outcome measures will include: EBP belief and EBP implementation scales (Melnyk &~     Fineout-Overholt, 2003); EBP knowledge cognitive test; # of lit searches conducted by unit RN~     staff ; # of requests for library support for lit searches or to obtain search-related~     articles: # of unit clinical policies with documented levels of evidence & research~     references. EBP belief, EBP implementation and EBP knowledge variables will be analyzed at~     both individual and unit levels of analysis. All other variables will be measured at the unit~     level of analysis. Additional unit level variables will include the following data collected~     annually as part of the National Database for Nursing Quality Indicator (NDNQI) RN~     satisfaction survey: satisfaction with RN-RN interaction, satisfaction with autonomy,~     satisfaction with practice decision-making, perceived quality of care delivered on the unit.~      The primary statistical procedures for analysis will be ANCOVA, ANOVAwith repeated measures,~     and logistic regression.~   "
223286|NCT00636038|"~     The study hypothesis is that high ß-C yellow maize can provide vitamin A efficiently.~      - list item one ß-C in yellow maize~      The study will use stable isotope labeled high ß-C yellow maize and vitamin A in a~     well-nourished population by utilizing stable isotope dilution techniques. In this project,~     deuterium labeled vitamin A that is derived from the labeled ß-C yellow maize will be traced~     after being eaten by a human subject. Eight men (> 40 years and < 70 y) who are healthy,~     non-smoking,body weight within 20% of standard weight for height (Metropolitan) and not~     having taken vitamin A or ß-C supplements within the last month will be recruited as~     volunteers. This study will last for 50 days during which at day 1, cooked labeled yellow~     maize paste (porridge) equal to a total of ~ 2 bowls cooked yellow maize (from 100 - 200 g~     dry weight) containing ~ 1 mg ß-C will be taken by each volunteer. On day 8, a labeled~     vitamin A (1 mg of 13C retinyl acetate) in oil dose will be used in evaluation of liver~     storage of vitamin A. Forty six blood samples (460 cc) will be taken during the study which~     will be analyzed for serum carotenoids and retinoids using HPLC and mass spectrometry~     techniques.~      The serum concentration and isotope ratio of ß-C and retinol will be determined. Serum~     enrichment curve following each oral dose will be studied. The area under the curve (AUC) of~     retinol-d4 and labeled retinol from the reference dose in serum samples will be determined~     and compared. The equivalence of a high ß-C corn meal to vitamin A will be calculated based~     on the isotope reference method to determine the efficiency of corn ß-C to provide vitamin A.~   "
223287|NCT00636025|"~     The purpose of this study is to compare the anatomy of subcutaneous structures in areas with~     and without cellulite on the buttocks of same subjects with a non invasive technique,~     Magnetic Resonance Imaging.~   "
223288|NCT00636012|"~     Aim of the study is to investigate specific effects of acupuncture points.~   "
223289|NCT00635999|"~     This study will evaluate the effectiveness of three adaptive coping treatments in lessening~     anxiety in adults with generalized anxiety disorder.~   "
223290|NCT00635986|"~     CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after~     epidural injection. The objective of this investigation was to compare the analgesic effect~     of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.~      DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo.~      METHODS: 29 patients were divided into two groups. During the postoperative period, in the~     presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in~     saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n =~     15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl~     intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL~     epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity~     was evaluated by numerical scale and plasma concentrations of Fentanyl were measured~     simultaneously.~   "
223291|NCT00635973|"~     A trial to assess patients who have been treated with Iressa in a previous clinical trial and~     may benefit from continued treatment with Iressa.~   "
223292|NCT00635960|"~     Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine,~     creatine, Vit. E, Pentoxifylline, etc. Although most of the trials showed a positive trend,~     none of them reached a statistically significant result. The only exception is the Riluzole~     trial, that demonstrated a small but significant reduction in mortality between treated and~     untreated patients. Aim of our study is to determine if the add-on of GH to treatment with~     Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients.~   "
223293|NCT00635947|"~     The purpose of this study is to determine the effect of maternal hydration with oral isotonic~     solution and water on amniotic fluid (AF) index in women with normohydramnios.~   "
223294|NCT00635934|"~     The purpose of this clinical trial is to collect safety and effectiveness data concerning the~     A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with~     lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary~     clinical endpoint.~   "
223295|NCT00635921|"~     Objective: The aim of this double-blind, placebo-controlled study was to evaluate the~     efficacy and tolerability of ziprasidone in the treatment of adult patients with Borderline~     Personality Disorder (BPD).~      Method: Sixty BPD patients were included in a 12-week, single-center, double-blind,~     placebo-controlled study. The subjects were randomly assigned to ziprasidone or placebo in a~     1:1 ratio following a two-week baseline period. The Clinical Global Impression scale for use~     in BPD patients (CGI-BPD) was the primary outcome measure, and other scales and self-reports~     related to affect, behavior, psychosis, general psychopathology domains and clinical safety~     were included.~   "
223296|NCT00635895|"~     The present study was designed to analyze and compare the effects of Manual Lymph Drainage~     Therapy and Connective Tissue Massage in females with Fibromyalgia (FM).~   "
223297|NCT00635882|"~     This is a 2-week double-blind, placebo-controlled, parallel group study comparing the~     anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol~     fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate~     (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent~     allergic asthma.~   "
223298|NCT00635869|"~     The primary aim of this pilot study is to evaluate the effects of two variations of the ARCC~     Intervention Program on nursing processes and outcomes (job satisfaction, group cohesion, EBP~     knowledge, EBP implementation, EBP beliefs), patient/family outcomes (e.g. pt/family~     satisfaction with care), and institutional processes and outcomes (e.g. nurse-physician~     collaboration, cost, RN turnover, incidence frequency relevant to the topic). Secondary aims~     are to test the feasibility of study methods and reliability and validity of questionnaires.~      This study is designed as a three-group randomized clinical trial with repeated measures.~     Three inpatient units (medicine, surgery, surgical intensive care) will be randomly assigned~     to one of three interventions: ARCC enhanced (didactic content presentations, use of an EBP~     tool kit which will stay on the unit, environmental EBP prompts, availability of an EBP coach~     on the unit); ARCC standard (all of the above, but without the coach); non-EBP intervention~     (didactic content and environmental prompts, but not related to EBP; placebo). The~     interventions will be implemented over an estimated 14 weeks, including a 4-week training~     period, and an estimated 10 weeks to implement an EBP initiative that the nurses on the two~     ARCC intervention units will develop.~      Baseline information and questionnaires will be collected from nurses at the start of the~     study, and again at completion of the intervention phase. Outcome data will be collected from~     nurses approximately 10 weeks after implementation of the ARCC interventions are completed~     (i.e., 22 weeks after the study is commenced). Nurse-physician collaboration data will be~     collected from physicians working with study unit nurses as well as from the nurses. Patient~     satisfaction data will not be separately collected in this study, but will include use of~     unit-level Press-Ganey scores immediately prior to and over the study time period. Unit level~     and institutional RN turnover will be tracked monthly during the entire study period and will~     be compared across units at the same time as well as compared within each study over time~     (i.e., unit retention during those same months in the previous year). Costs of each EBP~     intervention will be tracked during the study and compared descriptively. Survey data will be~     analyzed using analysis of variance statistics. Questionnaires will be tested for reliability~     and construct validity. Because this is a pilot study, statistically significant differences~     are not expected, however, effect sizes will be calculated~   "
223299|NCT00635856|"~     A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and~     who have rising PSA levels~   "
223300|NCT00635843|"~     The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™~     Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease~     at one level from L4-S1, with overall success being the primary endpoint of the clinical~     trial. The primary objective is to show non-inferiority of the investigational device to the~     control treatment. If non-inferiority is established, superiority will be examined.~   "
223301|NCT00635830|"~     To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is~     generally safe and well tolerated in the Chinese population.~   "
223302|NCT00635817|"~     The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are~     effective in treating children with Central Precocious Puberty (CPP).~   "
223303|NCT00635804|"~     This study will examine the safety, tolerability and plasma pharmacokinetics of multiple~     doses of MK-3281 in healthy male participants in Part I, and in Hepatitis C Virus~     (HCV)-infected male participants in Part II. The clinical efficacy of MK-3281, as measured by~     viral load reduction, will also be assessed in Part II. The primary hypothesis is that twice~     daily administration of MK-3281 for 10 days in healthy adult male participants and for 7 days~     in HCV-infected male participants is sufficiently safe and well tolerated, based on~     assessment of clinical and laboratory adverse experiences, to permit continued clinical~     investigation.~      The results of this study will guide dose selection for future studies in both healthy~     participants and HCV-infected participants.~   "
223304|NCT00635791|"~     This phase I trial studies the side effects and best dose of giving vorinostat and sorafenib~     tosylate together in treating patients with kidney or non-small cell lung cancer. Vorinostat~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Sorafenib tosylate may stop the growth of solid tumors by blocking blood flow to the tumor.~     Giving vorinostat together with sorafenib tosylate may kill more tumor cells.~   "
223305|NCT00635778|"~     This study will look for the highest tolerated dose of MK-0646 when given as a every other~     week infusion in patients with advanced solid tumors.~   "
223306|NCT00635765|"~     The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an~     additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.~   "
223307|NCT00635752|"~     The purpose of this study is to determine whether Trauma focused cognitive behavioral therapy~     (TF-CBT)is more effective in the treatment of traumatized youth than treatment as usual(TAU).~   "
223308|NCT00635739|"~     This research study is looking at the effects of a whey protein nutritional supplement on~     changes in muscle mass, strength and physical function in response to a 6 month program of~     strength training exercise.~   "
223309|NCT00635726|"~     This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC~     followed by gemcitabine and cisplatin, as first line treatment in patients with locally~     advanced or metastatic bladder cancer.~   "
223310|NCT00635713|"~     The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of~     ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast~     cancer.~   "
223311|NCT00635700|"~     This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for~     patients with the psychosis prodrome.~   "
223312|NCT00635687|"~     Transient elastography is a new non-invasive rapid and reproducible method, allowing~     evaluating liver fibrosis by measurement of liver stiffness.~      The aim of our study is to evaluate if the liver stiffness can predict the recurrence of~     upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.~   "
223313|NCT00635674|"~     The increased risk of atherosclerotic morbidity and mortality in patients with obstructive~     sleep apnea (OSA) has been linked to arterial hypertension, insulin resistance, systemic~     inflammation, and oxidative stress in previous studies.~      We aimed to determine the effects of 8-weeks therapy with continuous positive airway pressure~     (CPAP) on glucose and lipid profile, systemic inflammation, oxidative stress, and the global~     cardiovascular disease (CVD) risk in patients with severe OSA and metabolic syndrome.~   "
223333|NCT00635414|"~     This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg~     Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people~     with symptoms of Gastroesophageal Reflux Disease (GERD)~   "
223334|NCT00635401|"~     The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese~     smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers.~     Safety is evaluated by adverse events, laboratory tests, and other safety tests.~   "
223335|NCT00635388|"~     The primary objective of this study is to determine the appropriate study design for a~     full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in~     elementary school children relative to a placebo control.~   "
223314|NCT00635661|"~     The Stroke Rehabilitation Assessment of Movement (STREAM) is a relatively new measurement~     tool, which measures specific movement deficits (impairments) caused by a stroke. The STREAM~     is used to evaluate recovery of voluntary movement and basic mobility following the onset of~     a stroke. Several important clinical measurement properties of the STREAM remain to be~     explored, including its ability to measure impairments and clinical change in acute~     rehabilitation patients in the USA. We hypothesize that the STREAM will be able to detect and~     quantify a statistically significant change in the motor abilities of stroke patients from~     admission to discharge. An additional aim of the study is to compare the STREAM with two~     accepted and widely used clinical measures of function and disability, the Stroke Impact~     Scale (SIS)and the Functional Independence Measure (FIM). By linking movement deficits that~     are commonly assessed by physical therapists with measures of function and disability, the~     impact of the movement deficits can be understood.~   "
223315|NCT00635648|"~     To evaluate the safety, tolerability, and efficacy of caspofungin for the treatment of~     esophageal candidiasis and invasive candidiasis to support the registration of caspofungin~     for these indications in China.~   "
223316|NCT00635635|"~     Military sexual trauma (MST) is a significant women's mental health issue. There is a crucial~     need for effective therapies for MST-related posttraumatic stress disorder (PTSD) that are~     well-tolerated and can be flexibly administered in a variety of treatment settings. Guided~     imagery is a novel, transportable intervention technique that meets these requirements and~     warrants research in PTSD. The proposed study will be a randomized controlled trial of the~     Guided Imagery for Trauma (GIFT) intervention for women veterans with MST-related PTSD. This~     minimal contact intervention is designed to increase coping, affect management and relaxation~     skills, and to fostering more positive images and beliefs associated with surviving trauma.~     The feasibility and tolerability of GIFT have already been demonstrated in an open-label~     pilot of 15 women veterans with MST-related PTSD, with very promising initial results.~   "
223317|NCT00635622|"~     This is a phase IIa clinical trial in women with bacterial vaginosis. This study will~     determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy~     (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found~     in normal vaginal flora.~   "
223318|NCT00635609|"~     Randomized, multi-center, open label, active-comparator study to compare the efficacy and~     tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with~     moderate to severe acne vulgaris.~   "
223319|NCT00635596|"~     This phase I dose escalation study is intended to define the safety, tolerability and maximal~     tolerable dose (MTD) of MT110 in patients with advanced solid tumors.~   "
223320|NCT00635583|"~     Building stronger bones during pubertal growth could reduce lifelong fracture risk. This~     project is an 18 month dairy intervention study for overweight and healthy weight 4th-8th~     grade boys and girls. Half of the girls will receive dairy products to add to their habitual~     diet (milk, yogurt, and cheese) to equal three products per day, while the other half will~     remain on their normal diet. All participants will attend four study visits, each 6 months~     apart. At these visits height, weight, bone density and geometry, and fat and lean mass will~     be measured. This study aims to show that meeting calcium requirements by eating dairy~     products builds bigger, stronger bones, and that this effect may be enhanced in overweight~     boys and girls. The effect of the dairy intervention on body fat, lean mass, and weight, as~     well as the mechanisms and predictors of changes in bone mass and size and body composition~     will also be evaluated.~   "
223321|NCT00635570|"~     The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing®~     vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side~     effects, overall acceptability and intent to continue use of the method. The study is focused~     on the acceptability of the vaginal ring among female undergraduate or graduate students.~   "
223322|NCT00635557|"~     This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing~     glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin~     to three separate cohorts. Study endpoints will include determination of the maximum~     tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity~     of MPC-6827 when given with carboplatin.~   "
223323|NCT00635544|"~     The main objective of this study is to evaluate the effects of two diets with different~     glycemic index and fibre content on glucose metabolism and plasma lipid profile of 80~     adolescents in 4 European centres.~      Secondary objectives are to evaluate the effects of the two standardized diets on selected~     hormones and variables linked to inflammatory status.~   "
223324|NCT00635531|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability, and~     pharmacokinetics of alprazolam extended release (XR) for the treatment of adolescents with~     panic disorder~   "
223325|NCT00635518|"~     A cluster randomized field trial to evaluate the impact that training healthcare workers in~     healthy feeding practices has on the nutrition and health of children.~   "
223326|NCT00635505|"~     This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA~     Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered~     dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:~        1. Placebo control: (HFA propellant only, Treatment P); and~        2. Active control: 3M/Key's Proventil-HFA (Treatment R).~      The treatments will be given as self-administered oral inhalations in adult and adolescent~     patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week~     study is two actuations four times daily (QID).~   "
223327|NCT00635492|"~     Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual~     clinical practice will be enrolled and followed up for two years in order to describe actual~     practice with regards to the time on initial treatment regime, whether treatment regimens are~     being modified, what treatment modifications are made, and clinical and patient-reported~     outcomes.~   "
223328|NCT00635479|"~     The purpose of this research is to study the efficacy and cost effectiveness of the VAC~     device in comparison to traditional gauze wound dressing in pelvic, acetabular and hip~     fractures, specifically to see if there is a reduction in the incidence of post operative~     surgical wound drainage, infections, and hospital stay.~   "
223329|NCT00635466|"~     The purpose of this study is to examine the technical and oncological feasibility of~     laparoscopic surgery for rectal carcinoma~   "
223336|NCT00635375|"~     Hyperbilirubinemia is a common problem for term and preterm newborns in intensive care~     nurseries around the world. It is a condition in which there is too much bilirubin in the~     blood. Bilirubin is a substance that is naturally released when red blood cells break down.~     In the early newborn period, multiple factors lead to an abnormally elevated bilirubin level.~     Large amounts of bilirubin can circulate to tissues in the brain and may cause seizures or~     brain damage. About 6.1% of term newborns and a higher percentage of preterm newborns develop~     hyperbilirubinemia that requires treatment. Initiating treatment depends on many factors,~     including the cause of the hyperbilirubinemia, the level of serum indirect bilirubin, the~     rate of indirect bilirubin rise, and the age of the patient. The goal of treatment is to keep~     the level of bilirubin from rising to dangerous levels.~      The bilirubin molecule absorbs light. Therefore, treatment of hyperbilirubinemia involves~     exposure of the baby's skin to special blue spectrum light. Phototherapy is globally~     recognized as the standard of care for treatment of elevated indirect hyperbilirubinemia in~     the neonatal period. This light exposure converts water-insoluble indirect bilirubin to a~     more easily excreted soluble molecule. Over the last five years, several devices have been~     introduced that emit high intensity light in the blue portion of the visible light spectrum.~     However, despite frequent use of such therapy, the effectiveness of different phototherapy~     devices has not been adequately compared. The objective of this study is to compare the~     efficacy of the blue LED fiberoptic phototherapy with the metal halide spot phototherapy~     versus blue LED bank light phototherapy versus a combination of tandem therapy on lowering to~     total serum bilirubin.~   "
223337|NCT00635362|"~     The study is a randomized controlled trial comparing outcomes of immediate postplacental~     insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval~     insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled~     cesarean delivery.~      Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at~     12 months after delivery will be higher in the group randomized to immediate post-placental~     insertion.~   "
223338|NCT00635349|"~     The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5~     milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal~     anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a~     progressive and degenerative joint disease, in which the joints become painful and stiff)~     whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAIDs.~   "
223339|NCT00635336|"~     The purpose of this study is to evaluate the safety and clinical efficacy of novel~     vaccination for advanced bladder cancer.~   "
223340|NCT00635323|"~     To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with~     inoperable hepatocellular carcinoma.~   "
223341|NCT00635310|"~     Percutaneous liver biopsy (PLB) is the gold standard for grading necroinflammation and~     staging fibrosis in patients with chronic viral hepatitis. Whether the use of~     1-deamino-8-D-arginine vasopressin (DDAVP) before PLBs in hemodialysis (HD) patients with~     chronic viral hepatitis has comparable safety profiles to those with normal renal function~     (NRF) has not been evaluated in prospective studies.~   "
223342|NCT00635297|"~     Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures.~     Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those~     that have been treated with percutaneous vertebroplasty.~      The purpose of the study is to determine if prophylactic vertebroplasty of unfractured~     vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in~     adjacent vertebrae.~   "
223343|NCT00635284|"~     To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009~     given weekly; to characterize the toxicities of ABI-009; and to determine the pharmacokinetic~     parameters for ABI-009 when given on a weekly schedule.~   "
223344|NCT00635271|"~     This study will look for a relationship between asthma and factors released from the lungs in~     exhaled breath. If a relationship can be established, the identified factors may be used as~     biomarkers to predict episodes of increased asthma symptoms so that medications can be given~     to prevent the onset of an asthma attack.~      Healthy volunteers and people who have had asthma for at least 1 year may be eligible for~     this study. Candidates must be between 18 and 75 years of age.~      Participants undergo blood tests and breathing tests. For the latter, participants breathe~     into a machine before and after inhaling an asthma medication called albuterol. The machine~     measures the volume of air the subject can breathe out. Participants also provide a sample of~     exhaled breath by breathing normally for up to 30 minutes while wearing a mask devised for~     the procedure. Pulse rate, oxygen saturation and wheezing are monitored during the breath~     collection.~   "
223345|NCT00635258|"~     This prospective and randomized study was performed to evaluate whether the replacement of~     GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial~     preparation has any impact on pregnancy and implantation rates.~   "
223346|NCT00635245|"~     RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them.~      PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in~     treating patients with early-stage breast cancer that can be removed by surgery.~   "
223347|NCT00635232|"~     The purpose of this study is to learn which doses of PS433540 should be given to patients~     with high blood pressure to lower their blood pressure. This study will also examine how safe~     PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will~     be evaluated so that about 375 patients will be entered into the treatment phase of the study~     and be given PS433540.~   "
223348|NCT00635219|"~     The purpose of the study is to evaluate the efficacy and the tolerability of three fixed~     doses of Vortioxetine in order to establish the appropriate clinical effective dose range in~     the treatment of Major Depressive Disorder (MDD).~   "
223358|NCT00635089|"~     This study is an open-label study where all subjects will receive active drug, reslizumab.~     Subjects are able to enter this trial only through completion of study Res-05-0002~     (NCT00538434).~      The goal of the study is to show longer term safety and efficacy in pediatric subjects who~     have eosinophilic esophagitis.~   "
223359|NCT00635076|"~     The purpose of this study is to evaluate the long-term (6-month) efficacy, safety, and~     tolerability of alprazolam XR in adolescents with panic disorder.~   "
223349|NCT00635206|"~     The primary objective outcome is the proportion of participants compliant (at least four~     hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group~     after 90 days of treatment during the investigation. Proportion will be calculated using the~     cumulative number of hours on therapy divided by the total number of days of the~     investigation for each participant. The mean and standard deviation of these mean therapy~     hours will then be calculated for each arm of the investigation. Participants with compliance~     of at least four hours will be classified as compliant and those with less than four hours~     will be classified as non-compliant. The null hypothesis will be rejected if the mean of~     the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy~     arm is significantly greater than that for all participants in the CPAP therapy arm.~      Secondary Measures~      The secondary measures used to evaluate potentially improved adherence to BiPAP® Auto with~     Bi-Flex® therapy compared to CPAP therapy will include:~        -  Hours of use per night, for all nights~        -  Hours of use per night, for nights with therapy use~        -  Device derived AHI~        -  Heart Rate Variability~        -  Functional Outcomes of Sleep Questionnaire (FOSQ),~        -  10 cm Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy,~        -  Epworth Sleepiness Scale (ESS) questionnaire~        -  Psychomotor Vigilance Task~        -  Attitudes toward use~        -  Actigraphy (sleep continuity) and sleep diary~        -  Fatigue Severity Scale~        -  Daytime Functioning Scale~   "
223350|NCT00635193|"~     This is an open-label study of liposomal doxorubicin with or without volociximab for the~     treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer~     relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic~     integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a~     surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in~     terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft~     models. In clinical studies, volociximab has been evaluated in several solid tumor types,~     including pancreatic, renal, and melanoma, with many subjects who entered the studies with~     progressive disease remaining progression-free for several months. In all studies in solid~     tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks~     and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal~     doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed~     after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and~     safety. The investigators have thus far activated stage 2 of this study at 11/25 sites.~     Worldwide, the study aims to enroll 150 subjects.~   "
223351|NCT00635180|"~     The purpose of this study is to investigate changes in intraocular pressure measured~     continuously during isometric exercise.~   "
223352|NCT00635167|"~     Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity~     (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic,~     hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated~     vascularity through several mechanisms, including apoptosis (process of cell death) and~     anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the~     investigators' center, they have demonstrated that increased prostatic vascularity (blood~     vessels defined to prostate) detected ultrasonographically correlated with disease free~     survival after radical prostatectomy (surgical removal of entire prostate), and may be~     indicative of higher grade, higher stage disease. The significance of prostate neovascularity~     in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not~     been well studied. The investigators hypothesize that prostate cancer that recurs after~     radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may~     represent a minimally invasive marker of cancer stage, grade and response to treatment. The~     investigators propose a pilot study to assess the feasibility of serial enhanced transrectal~     ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer.~   "
223353|NCT00635154|"~     RATIONALE: Some cancers need growth factors which are made by the body's white blood cells to~     keep growing.Anakinra may interfere with the growth factor and stop multiple myeloma from~     growing. Dexamethasone may stop cancer cells from growing. Giving anakinra together with~     dexamethasone may be an effective treatment for multiple myeloma.~      PURPOSE: This phase II trial is studying how well anakinra works when given with or without~     dexamethasone in treating patients with smoldering myeloma or indolent multiple myeloma.~   "
223354|NCT00635141|"~     This study is examining the effect of hypertonic saline compared to placebo on the Lung~     Clearance Index in Cystic Fibrosis patients.~   "
223355|NCT00635128|"~     Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be~     evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will~     be evaluated in terms of immunogenicity, safety and reactogenicity.~   "
223356|NCT00635115|"~     The VEPRO trial is a cross-over randomised controlled trial comparing 2 corrective lenses for~     patients with presbyopia. The aim of the study is to compare the effectiveness of two~     corrective lenses: an old generation (Varilux Comfort Orma Crizal) and a new generation~     (Varilux Panamic Orma Crizal) of corrective lenses prescribed in presbyopia.~   "
223357|NCT00635102|"~     Question #1: Will glycine ameliorate cognitive deficits? Hypothesis #1: Based on positive~     findings conducted with glycine and milacemide, a glycine prodrug, in schizophrenia and~     dementia, we expect that glycine will ameliorate cognitive deficits.~      Question #2: Will alcoholic patients show enhanced endocrinal effects to glycine? Hypothesis~     #2: Based on the dose-related effects of glycine in healthy subjects, we expect that glycine~     will increase the endocrinal response to glycine in alcoholic patients with, supposedly,~     dysregulated NMDA receptor function.~      Question #3: Will D-cycloserine have ethanol-like effects? Hypothesis #3: If inhibition of~     NMDA receptor function is fundamental to the subjective effects of ethanol, then the NMDA~     antagonist properties of D-cycloserine should be recognized as ethanol-like (relative to~     placebo) in recently detoxified alcoholics and healthy subjects.~      Question #4: Will D-cycloserine reverse cognitive benefits of glycine? Hypothesis 4: Based on~     the dose related NMDA antagonist activity of D-cycloserine, we expect that D-cycloserine will~     compete with the agonist activity of glycine and therefore it will reverse the cognitive~     benefits of glycine.~      Question #5: Will D-cycloserine inhibit endocrinal effects of glycine? Hypothesis #5: If the~     agonist activity of glycine is necessary to determine endocrine response, then the~     dose-related NMDA antagonist properties of D-cycloserine should block these effects.~   "
223360|NCT00635063|"~     Purpose:~      The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely~     used current treatment (MSIR) in the management of target BTP in subjects with malignancies~     who are taking a stable dose of background opioids. The efficacy evaluation criteria have~     been designed to determine whether AD 923 provides superior analgesia compared with MSIR as~     measured by the primary endpoint.~   "
223361|NCT00635050|"~     This study will evaluate the rate of pathological complete response (pCR) to the sequential~     therapy of Doxil, paclitaxel, and cyclophosphamide with concurrent Avastin for patients with~     locally advanced invasive (T2,T3, Nany, M0) breast carcinoma. Also, the study will evaluate~     the clinical and subclinical cardiotoxic effect(s) of this regimen, assess how feasible and~     safe the study is. Survival without any progression of disease will also be calculated.~      A regimen of chemotherapy will be given to replicate the high rate of pCR seen with~     conventional chemotherapy in patients with locally advanced breast cancer. Doxil will~     substitute the normally given doxorubicin. It is expected that the low effect or minimal~     effect of Doxil on cardiac function will minimize any additional risk of cardiotoxicity from~     Avastin. It is expected that clinical and subclinical rates of cardiotoxicity will be very~     low at the total doses to be given in this clinical trial.~   "
223362|NCT00635037|"~     CONTEXT AND OBJECTIVE: Myofascial syndrome is the most frequent condition of chronic pain.~     The objective of the present study was to compare the analgesic action of acupuncture and~     trigger point injection combined with cyclobenzaprine and dipyrone.~      DESIGN AND SETTING: A randomized study was performed at the Pain Clinic. METHODS: Thirty~     patients were divided into two groups: G1 received trigger point injection of 0.25%~     bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8~     h. G2 was submitted to classical and trigger point acupuncture twice a week. The patients~     were asked to continue physical exercise. The following parameters were evaluated: pain~     intensity rated on a numerical and verbal scale, quality of life before and four weeks after~     treatment, and quality of analgesia.~   "
223363|NCT00635024|"~     RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune~     system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such~     as melphalan, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer~     cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may~     kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together~     with melphalan works in treating patients with relapsed multiple myeloma.~   "
223364|NCT00635011|"~     The purpose of this study is to investigate the relationship between the potential predictive~     psychological variables and success after bariatric surgery. The investigators will also~     investigate the purpose of a pre- and postoperative psychological intervention.~   "
223365|NCT00634998|"~     The purpose of this pilot study is to determine whether vitamin C supplementation is~     beneficial in treating and/or preventing diabetic peripheral neuropathy in people with type 2~     diabetes.~   "
223366|NCT00634985|"~     To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who~     had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)~   "
223367|NCT00634972|"~     The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye~     drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or~     decrease its severity.In this study ACULAR will be compared to a placebo (artificial tear).~      The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to~     severe ROP (grade II and above)by 50%.~   "
223368|NCT00634959|"~     To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc~     (UK-427,857) in patients with human immunodeficiency virus (HIV)~   "
223369|NCT00634946|"~     The purpose of this study is to determine whether SI-6603 is effective in the treatment of~     lumbar disc herniation.~   "
223370|NCT00634933|"~     This study will evaluate the efficacy and safety of two dosing regimens of a compound known~     as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid~     arthritis.~   "
223371|NCT00634920|"~     This study is designed to evaluate if early conversion to everolimus from cyclosporine in de~     novo renal transplant recipients can improve long-term renal function and slow down the~     progression of chronic allograft nephropathy~   "
223372|NCT00634907|"~     Several human genes affect how medications are metabolized by the body. It is believed that~     knowledge of variations of these genes can help health care providers better manage an~     anticoagulation medicine called warfarin (Coumadin®)and as a result decrease patient problems~     with bleeding or the development of blood clots. This study was designed to evaluate if~     genetic testing can improve warfarin initiation better than usual care.~   "
223373|NCT00634894|"~     Primary Objective:~      1. Evaluate the efficacy of letrozole to increase the duration of progression-free survival~     (defined as time to earliest occurrence of local or distant recurrence or clinically~     significant elevation in CA-125) when used as adjuvant treatment after completion of primary~     surgery and first line platinum containing chemotherapy in patients with optimally debulked~     (< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal~     cancer.~      Secondary Objective:~      1. Observe the incidence of local and distant recurrences.~   "
223374|NCT00634881|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab in~     treating patients with B-cell chronic lymphocytic leukemia.~   "
223375|NCT00634868|"~     The Qray device is emitting broad light energy that is intended for diabetic ulcer healing.~     The study is double blinded.~   "
223376|NCT00634855|"~     The objective of this study is to determine whether there are alterations in the population~     of endothelial progenitor cells in umbilical cord blood samples of infants born in the~     setting of maternal preeclampsia or fetal growth restriction.~   "
223377|NCT00634842|"~     This trial is conducted in the United States of America. The aim of this trial is to explore~     how different fasting blood glucose targets affect glucose control in patients with type 2~     diabetes, when patients are empowered to do dose adjustments themselves.~   "
223378|NCT00634829|"~     This clinical study will evaluate and establish the protective effects of Amphastar's~     Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA), in preventing exercise-induced~     bronchoconstriction (EIB) in adolescent and adult asthmatic patients, in comparison with (1)~     Proventil®-HFA (Reference drug and Active Control ), and (2) Placebo-HFA control (HFA~     propellant only). Safety of the test drug, Albuterol-HFA, will also be evaluated in~     comparison to the Active and Placebo Controls. Analyses will be performed to determine if the~     Armstrong's Albuterol-HFA has resulted in a significant bronchoprotective effect, with~     attenuated Max % Fall in FEV1, in comparison to the Placebo-HFA control.~   "
223379|NCT00634816|"~     Specific subgroups of children who survive treatment for childhood malignancies have been~     shown to develop relative osteopenia following chemotherapy and are felt to be at risk for~     developing osteoporosis later in life due to their inability to reach peak bone mass during~     childhood.~   "
223380|NCT00634803|"~     This study is designed to develop an effective psychotherapy for chronic pain and opioid~     dependence.~   "
223381|NCT00634790|"~     The purpose of this study is to assess the long-term safety and tolerability of alprazolam~     extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in~     anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR~     and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will~     also be evaluated.~   "
223382|NCT00634777|"~     Patients with advanced head and neck squamous cell carcinoma (HNSCC) may benefit from~     organ-preservation treatment based on combination of chemotherapy and radiotherapy without~     compromising disease-free and overall survival. In patients with initially advanced regional~     disease, there is controversy about the place of routine planned lymph node neck dissection~     after chemoradiotherapy, especially in responding patients without clinically invaded~     residual lymph nodes. There is uncertainty about the lymph nodes status after chemoradiation~     because the structural imaging modalities (CT, MRI) lack sensitivity and specificity : small~     positive lymph nodes are not detected, and residual large lymph nodes can be sterilized ( ~     ghosts nodes  with no sign of viable tumor cells at histopathology). Despite the absence of~     evidence based on prospective study, in numerous institutions currently, head and neck~     surgeons are quite reluctant to operate on for neck dissection patients with a complete~     clinical and radiological response following chemoradiation.~      Metabolic imaging of tumors using PET and the glucose analog FDG has proven effective in head~     and neck SCC, especially after treatment to differentiate disease progression from~     radiation-induced inflammation.1 Several studies have shown that the metabolic response could~     predict the presence or absence of residual tumor cells in the primary tumor as well as the~     probability of relapse .2-4 Conflicting results have been reported on the use of PET to~     predict the pathological nodal status after chemoradiation, with negative predictive values~     ranging from 14 % to 100 %.5,6 Discrepancies observed might be due to the fact that PET was~     performed at variable time points after the end of radiotherapy. Ideally, PET should be~     performed as late as possible so that tumor regrowth can begin and become detectable,~     increasing the sensitivity of the procedure.~   "
223383|NCT00634764|"~     Obesity is a significant health issue in the United States with 30% of the US population~     considered obese defined as a body mass index above 30 kg/m2. Obesity is associated with long~     term health complications including diabetes and cardiovascular disorders. During pregnancy,~     obesity is associated with an increased risk of fetal macrosomia and birth injury, as well as~     increased risk of gestational diabetes, preeclampsia, cesarean birth, and preterm birth. The~     intrauterine environment has been purported to influence the early childhood and lifelong~     risk of obesity and the metabolic syndrome (obesity, hyperlipidemia, and insulin resistance~     [IR]). The Institute of Medicine guidelines for maternal weight gain in pregnancy provide an~     estimate for population goals, but may be inadequate for individual patient needs. Other~     factors, such as the degree of maternal IR and resting metabolic rate (RMR) may be more~     predictive of actual nutritional needs during pregnancy. A better determination of caloric~     and exercise needs may allow the development of more specific dietary recommendations during~     pregnancy. Optimal nutrition will result in improved maternal and neonatal outcomes. As the~     intrauterine environment may have important impacts on neonatal and childhood metabolic and~     cardiovascular outcomes, creation of a favorable intrauterine environment through optimal~     maternal nutritional and exercise guidelines may reduce well documented problems such as~     fetal macrosomia, birth injury, cesarean delivery, and later predisposition toward childhood~     obesity.~      The goal of this pilot trial therefore is to correlate maternal resting metabolic rate,~     dietary characteristics, and insulin resistance levels with fetal birth weight and body~     composition in an effort to determine which factors are associated with excessive fat mass in~     the neonate, placing them at increased lifetime risk of obesity.~      We hypothesize that women with lower resting metabolic rates (RMR) in the first trimester~     will demonstrate a greater maternal weight gain, when adjusted for caloric intake and~     activity. It is also hypothesized that for a given RMR, the degree of maternal insulin~     resistance (IR) predicts birthweight adjusted for a given caloric intake. A third hypothesis~     is that women with increased insulin resistance (measured by HOMA) will result in neonates~     with larger birth weights and a greater degree of neonatal fat mass as measure by DEXA scan,~     adjusted for RMR and diet characteristics.~   "
223384|NCT00634751|"~     This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs~     approved by the Food and Drug Administration (FDA) for use in the treatment of different~     cancers. Their use in this exact combination is considered experimental for the treatment of~     pancreas and biliary tract; however the combination has been tested in a preliminary trial.~     We are also testing a survey designed. The purpose of this research study is to investigate~     the chemotherapy drug sorafenib in combination with oxaliplatin and capecitabine~     chemotherapies for the treatment of pancreas and biliary tract cancers.to help patients~     report their side effects from chemotherapy treatments.~   "
223385|NCT00634738|"~     In carpal tunnel syndrome,trigger points are often found in the biceps muscle,in the~     aponeurosis of the biceps and in the pronator teres muscle.~      We hypothesise that by eliminating these trigger points,using ischemic compressions, may~     diminish the symptoms.~   "
223386|NCT00634725|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor~     cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or~     radiation therapy is most effective in treating pancreatic cancer.~      PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or~     without capecitabine and/or radiation therapy to see how well it works compared with giving~     gemcitabine together with or without erlotinib in treating patients with locally advanced~     pancreatic cancer that cannot be removed by surgery.~   "
223387|NCT00634712|"~     A study to evaluate the effect of Atacand on patients with heart failure with preserved left~     ventricular function~   "
223388|NCT00634699|"~     The purpose of this study is to find the efficacy of treating the muscles in the inside~     (biceps,pronator teres) of the arm in order to eliminate the carpal tunnel syndrome .The~     authors hypothesise that eliminating the trigger points located in these muscles would~     diminish the symptoms associated with the carpal tunnel syndrome.~   "
223389|NCT00634686|"~     The purpose of this study is to examine the effects of essential fatty acid (EFA)~     supplementation on bone metabolism and frailty in postmenopausal women. The overall~     hypothesis is that EFA supplementation, via its immunoregulatory and anti-inflammatory~     activity, will decrease bone turnover, decrease prostaglandins and cytokines associated with~     bone metabolism and frailty, and change physical outcome measures associated with frailty in~     postmenopausal women with low bone mass and frailty.~   "
223390|NCT00634673|"~     This study will be conducted in type 2 diabetic patient's to evaluate the if there is a~     different response of serum lipids after a standard meal (rich in saturated fatty acids) in~     patients who have the presence of a genetic alteration. This alteration that will be~     evaluated is a polymorphism, change of an amino acid in the gene of FABP2. This gene that can~     influence the absorption of lipids in the intestine and subjects who have the altered~     genotype (presence of T allele) can have an abnormal lipid profile as compared to subjects~     without this genotype.~   "
223391|NCT00634660|"~     The purpose of this study is to assess the safety and tolerability of injections of~     rAvPAL-PEG in subjects with PKU.~   "
223392|NCT00634647|"~     Background:~      Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer.~      Prednisone is approved for treating prostate cancer.~      The gene excision repair cross-complementing rodent repair deficiency complementation group 1~     (ERCC1) helps repair cell damage caused by satraplatin. It is possible that patients who have~     a variant of this gene will not benefit from treatment with satraplatin because the drug will~     not be able to damage the cancer cells effectively.~      Objectives:~      To determine if satraplatin may help treat prostate cancer in patients with certain variants~     of the ERCC1 gene.~      Eligibility:~      Patients with advanced androgen-independent prostate cancer whose disease has not responded~     to hormonal therapy or at least one type of chemotherapy and whose x-rays, scans or other~     tests have shown their cancer to be spreading.~      Design:~      Participants have a blood test to determine if they have a variant of the ERCC1 gene.~      Participants take satraplatin by mouth every day for 5 consecutive days out of every 35 days~     and prednisone by mouth every day. These 35-day treatment cycles may continue for 6 months or~     longer, depending on the benefits and side effects of the treatment.~      During the treatment period, patients undergo the following tests and procedures:~        -  Blood tests on days 1 of the treatment cycle.~        -  Weekly blood draws for the first 3 treatment cycles.~        -  Imaging studies (e.g., bone scans, computed tomography (CT) scans) every two cycles to~          determine the response to treatment.~        -  Surgical or medical suppression of testosterone in patients whose cancer cells continue~          to grow due to exposure to the hormone....~   "
223393|NCT00634634|"~     Letrozole is an aromatase inhibitor that is approved in the first-line treatment of~     postmenopausal women with hormone receptor-positive or hormone receptor unknown locally~     advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by~     blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.~     This phase I/II trial is studying the side effects and best dose of sorafenib when given in~     combination with letrozole and to see how well they work in treating postmenopausal women~     with metastatic breast cancer.~   "
223394|NCT00634621|"~     The purpose of this study is to determine the effectiveness of hexaminolevulinate (Hexvix) in~     the diagnosis and treatment of patients with non-invasive bladder cancer and if it results in~     a change in patient management.~   "
223395|NCT00634608|"~     The specific aim of this proposed project is to implement a standard process for integrating~     MedlinePlus health information prescriptions into the clinic workflow.~      Hypothesis 1: Individuals in the intervention group who receive tailored email health~     information with provider selected MedlinePlus links and added commentary for patient~     specific conditions will be more likely to seek information / use MedlinePlus compared with~     individuals in the control group.~      Hypothesis 2: Individuals in the intervention group who receive tailored email health~     information with provider selected MedlinePlus links and added commentary for patient~     specific conditions will be more satisfied with the information received compared with~     individuals in the control group.~   "
223396|NCT00634595|"~     Angiogenesis, the formation of new blood vessel from existing vessels, is essential for tumor~     growth and metastasis. Antiangiogenic therapies inhibit the growth of genetically stable~     endothelial cells, and most tumors should starve to death with little acquired resistance.~     Endostatin has been shown to block endothelial cell proliferation, survival, and migration.~     Antitumor activity of endostatin protein has been demonstrated in various murine and human~     tumors in animal model studies without any detectable toxicity. Endostatin gene therapy could~     directly express the highly bioactive protein in vivo by means of the mechanism of eukaryotic~     expression system as post-translational modification and folding, as well as overcoming the~     challenge of the long-term storage and the cumbersome daily administration of endostatin~     protein.~      E10A is a replication-deficient recombinant adenovirus containing a wild-type human~     endostatin transgene constructed from serotype 5 adenovirus (Ad5). Preclinical studies~     demonstrated that intratumoral injection of E10A provided significant tumor growth inhibition~     and sustained elevation of endostatin in blood and tumor tissue in hepatocellular carcinoma,~     nasopharyngeal carcinoma, and tongue cancer animal models. A Phase I clinical trial of E10A~     we conducted showed that repetitive intratumoral injection of E10A resulted in a small and~     sustained elevation of endostatin in blood and had a mild antitumor activities with very~     limited toxicity. The major toxicity was transient and manageable fever. A randomized Phase~     III trial in nonsmall-cell lung cancer showed endostatin improved response rate and time to~     tumor progression in combination to chemotherapy. Therefore, we designed a randomized phase~     II trial to explore the safety and effectiveness of E10A combined with chemotherapy in the~     treatment of patients with head and neck cancer.~   "
223397|NCT00634582|"~     RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to~     grow and spread more slowly. It may also stop the growth of tumor cells in bone.~      PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients~     with advanced prostate cancer and bone metastases.~   "
223398|NCT00634569|"~     This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5%~     DIF in the pediatric population.~   "
223399|NCT00634556|"~     Dr. Kevin J. Black at Washington University is conducting a study to learn whether we can use~     MRI scans to test dopamine function in the brain and to determine whether the brain performs~     memory tasks differently in Tourette Syndrome (TS). TS is a movement disorder characterized~     by vocal tics (sounds) and motor tics (movements). We will measure how and where brain~     activity changes using magnetic resonance imaging (MRI) scans during memory tasks and after~     taking levodopa. Levodopa is a drug commonly used for the treatment of Parkinson's disease~     (PD), a very different movement disorder.~   "
223400|NCT00634543|"~     The purpose of this study is to evaluate the effectiveness and safety of tramadol~     hydrochloride (HCl) 37.5 miligram (mg)/acetaminophen 325 mg compared to gabapentin in~     participants with diabetic neuropathic (nerve disorder caused by diabetes mellitus) pain.~   "
223578|NCT00632190|"~     RATIONALE: New diagnostic procedures, such as spectroscopy, may be a less invasive way to~     check for dysplasia and neoplasia in the cervix. Spectroscopy may also used as a screening~     test to help doctors find cervical cancer sooner, when it may be easier to treat.~      PURPOSE: This clinical trial is studying how well spectroscopy works in diagnosing dysplasia~     and neoplasia in the cervix in women undergoing colposcopy or Pap testing.~   "
223401|NCT00634530|"~     This is a randomized clinical trial for evaluate the impact of a nutritional intervention in~     the weight control of pregnant women according to the nutritional status, and consequently,~     the reduction of pregnancy complications.~      The sample of this study will be composed by 318 pregnant women in the pre-natal care unit of~     the Health Center in Viamão city / Rio Grande do Sul, including women between the 10th and~     25th weeks of gestation, aged up to 35 years old. The eligible pregnant women will be invited~     by the fieldworks to participated in the trial after be informed about the overall aims of~     the study. These women willing to participate will be randomly allocated to either the~     intervention or control group. The intervention group received specific guidelines about~     feeding practices appropriate to each nutritional status.~      Data on pregnant women will be collected through a questionnaire in both groups, and to~     assess the food intake, three 24-hour food recall will be applied in the interventional group~     and two recall in the control group, in initial and final gestational period. In all~     appointments pregnant women of the two groups will be weight and classified according to Body~     Mass Index of pre-gestational (BMI).~      The dietary advices will be elaborated by the author of the project and nutrition graduation~     students of Federal University of Health Science of Porto Alegre.~   "
223402|NCT00634517|"~     This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA~     Inhalation Aerosol in comparison with the Active Control, Proventil-HFA (3M Pharmaceuticals,~     Inc) in pediatric patients (4-11 years old) with mild-to-moderate asthma. In addition,~     pharmacokinetic profile in this population will be evaluated using a population PK approach~     with sparse blood samples.~   "
223403|NCT00634504|"~     The purpose of this study is to investigate whether the administration of Voraxaze reduces~     exposure to leucovorin and its active metabolite to below the level achieved in patients who~     have not received Voraxaze.~   "
223404|NCT00634491|"~     The purpose of this study is whether Acetazolamide is effective in prevention of contrast~     nephropathy~   "
223405|NCT00634478|"~     The hypothesis is that prelemniscal radiation (RaPRL) deep brain stimulation (DBS) is more~     effective for axial (head/neck/voice) tremor, and perhaps, appendicular tremor control in~     essential tremor patients.~   "
223406|NCT00634465|"~     Assessment of segmental spine motion has been and continues to be, a difficult clinical~     problem. Errors of up to 10 degrees for simple measurements of flexion, extension and side~     bending have been recorded using conventional radiographs (xrays.) These errors are usually~     associated with the inability to acquire three-dimensional positions and inaccurate reference~     points. It has, therefore, been extremely difficult to measure small changes in vertebral~     alignment, which may prove to be an early, clinically significant, indicator of potential~     problems. Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique~     using two simultaneous radiographs. It provides researchers with three dimensional motion~     analyses to look not only at routine flexion/extension, but also other rotational and~     translational changes. The measurement accuracy offered by this technique far exceeds the~     manual techniques currently used. The purpose of this study is to assess the amount of motion~     in the lumbar spine in patients with the AST Stabilimax BAR. The AST Stabilimax BAR is~     designed to allow for motion in the spine while providing the necessary stability to the~     spinal segment. The amount and degree of this motion is currently unknown clinically. By~     using tantalum bead markers placed in the spine at the time of the surgery, RSA analysis can~     determine the amount and degree of motion of the implanted construct. Two questions will be~     examined with this data: 1) what is the amount of sagittal and coronal plane motion that~     occurs in vivo with the AST Stabilimax BAR system? and 2) will this change over the 2 year~     time frame for this study?~   "
223407|NCT00634452|"~     To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or~     refractory Hodgkin's Lymphoma (HL).~   "
223408|NCT00634439|"~     Using a proprietary insurance health claims database, Eli Lilly and Company has contracted~     with an external party to conduct a retrospective cohort study of health claims for the time~     period from 1 January 2003 through 31 December 2006 (with follow-up of patients through 30~     June 2007). This study will evaluate the potential association between atomoxetine and~     cerebrovascular events. In this study, the incidence of selected cerebrovascular outcomes as~     represented in health claims data among adult patients who initiate therapy with atomoxetine~     will be estimated. In particular the study will focus on cerebrovascular accident (CVA) and~     transient ischemic attack (TIA) as the outcomes of interest. The incidence for each outcome~     among atomoxetine initiators will then be compared to the incidence in a cohort of similar~     patients who initiate stimulant treatment and an age and gender-matched general population~     cohort. The atomoxetine and stimulant-initiating cohorts will be matched on a broad variety~     of variables, including age, gender, diagnoses, medication use, and healthcare utilization~     through the use of propensity score matching in order to minimize the influence of~     confounding by indication. The analysis will include the cohorts (atomoxetine and stimulant~     initiators) from a previous completed study with increased follow-up time (1 January 2003~     through 30 June 2007) and accrue new atomoxetine and stimulant ADHD medication initiators~     over a 2 year period, so that the study will represent initiators between January 1, 2003 and~     December 31, 2006 with follow-up through June 30, 2007.~   "
223409|NCT00634426|"~     The aim of this trial is to evaluate the differences in pain relief, neurological function,~     quality of life and survival in patients with metastatic epidural spinal cord compression~     (MESCC) who are managed with a combination of surgery and radiotherapy versus radiotherapy~     alone.~      Further we shall evaluate cost-effectiveness of the two treatment approaches.~   "
223410|NCT00634413|"~     The purpose of this study is to assess the tolerability and efficacy of inhaled theophylline~     (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in~     bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary~     Disease (COPD) when co-administered with budesonide and compared to placebo.~   "
223411|NCT00634400|"~     A study to evaluate the effect of Atacand on patients with heart failure with depressed left~     ventricular function~   "
223412|NCT00634387|"~     Anthocyans modify cardiovascular and sympathetic function~   "
223579|NCT00632164|"~     A study to determine if a chiropractic adjustment in the cervical spine will effect the~     parasympathetics and a chiropractic adjustment in the thoracic spine will effect the~     sympathetics.~   "
223413|NCT00634374|"~     Hypothesis: The Rx medibottle is more effective than the oral syringe when giving infants~     less than 2 years of age a bitter-tasting medication (prednisolone syrup).~      Summary: Infants who were admitted to the pediatric floor with a respiratory illness at the~     Bronx-Lebanon Hospital were offered the chance to take part in the study. If these children~     needed prednisolone syrup for their treatment, were less than 2 years old and were~     bottle-fed, and were in stable condition, they qualified. They were randomly assigned (just~     by chance), into a control arm, where they received medication using the oral syringe, or an~     intervention arm, where they were given medication using the Rx medibottle. How well the~     infant accepted the bitter-tasting medication was compared between the two arms using an~     infant medication acceptance scale. The scale was administered and a score generated by two~     raters: the nurse who administered the medication, and a child life therapist who witnessed~     the administration. The time needed to give the medication, the drug delivery device's~     ability to administer the entire dose of medication and the mother's satisfaction with the~     method used were also compared between the two arms.~   "
223414|NCT00634361|"~     This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia~     prodrome.~   "
223415|NCT00634348|"~     The purpose of this study is to compare the efficacy and safety of ziprasidone and~     aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder~   "
223416|NCT00634335|"~     The purpose of this study is to characterize the cardiac adaptive changes of professional~     Israeli bicyclists by using echocardiography.~   "
223417|NCT00634322|"~     The purpose of this study is to demonstrate whether use of glucarpidase facilitates~     administration of the next cycle of chemotherapy as scheduled and improves safety and~     tolerability of HDMTX given with LV~   "
223418|NCT00634309|"~     A study to evaluate the effect of Atacand on patients with heart failure with depressed left~     ventricular function~   "
223419|NCT00634296|"~     This study aims to compare effects of inspiratory muscle training added by aerobic training~     to aerobic training alone in heart failure patients with inspiratory muscle weakness. To do~     so, strength and endurance of inspiratory muscles, functional capacity, quality of life,~     heart rate variability and sleep apnea evaluations will be conducted in patients with heart~     failure.~   "
223420|NCT00634283|"~     This study examines the effects of an antidepressant medication and placebo on the brain~     functioning of normal subjects. In this study, recordings of brain electrical activity are~     being used to detect and monitor the response to treatment with venlafaxine IR (Effexor), a~     drug used for the treatment of depression. The intent of this study is to test specific~     hypotheses regarding:~        1. long-term brain effects of a single course of antidepressant treatment~        2. pharmaco-conditioning effects underlying antidepressant tolerance/sensitization~        3. brain functional response to initial versus subsequent antidepressant trials in normal~          healthy subjects.~   "
223421|NCT00634270|"~     Treatment Overview~      This phase II study will evaluate the activity of sirolimus in children and adults with NF1~     and inoperable plexiform neurofibromas that have the potential to cause significant~     morbidity. The following disease strata will be studied:~      Stratum 1: Progressive plexiform neurofibroma(s) that have the potential to cause significant~     morbidity. The endpoint will be time to tumor progression based on volumetric tumor~     measurements.~      Stratum 2: Plexiform neurofibromas without documented radiographic progression at trial~     entry. The endpoint will be radiographic response. As of May 2009, Stratum 2 was closed to~     enrollment. Stratum 1 is active.~   "
223422|NCT00634257|"~     Primary Objective:~      -To examine the association between self-rated spirituality/religiosity and coping strategies~     (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.~      Secondary Objectives:~        -  To examine the associations between self-rated spirituality/religiosity and physical~          (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among~          palliative care patients.~        -  To examine the association between patient's self-reported spirituality/religiosity, and~          primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire,~          FACIT-sp).~        -  To determine the frequency (self-rated spiritual pain scale when score is more or equal~          than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the~          palliative care setting and to explore the association between spiritual pain, and~          negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms~          (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment~          questionnaire).~        -  To examine the association between primary caregivers' spirituality/religiosity~          (Appendix H, first question), religious coping strategies (Brief-RCOPE) and~          psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver~          self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second~          question).~   "
223423|NCT00634244|"~     This randomized phase II trial is comparing three different combination chemotherapy regimens~     to see how well they work in treating patients with relapsed or refractory acute myeloid~     leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating patients with relapsed or~     refractory acute myeloid leukemia.~   "
223424|NCT00634231|"~     This study will evaluate the administration of AdV-tk followed by valacyclovir in children~     with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma~     (AA), as well as recurrent ependymomas in combination with radiation therapy. The primary~     objective is to determine if this approach is safe and can be effectively delivered without~     disturbing standard therapy.~   "
223452|NCT00633854|"~     The objective of this research is to improve the care of ocular disease and disorders, in~     particular the changes in the eye associated with diabetes, by providing clinicians with~     dramatically improved ultrasonic images of the entire eye. The research combines advanced~     high-frequency, high-resolution ultrasonic annular arrays transducers with new processing~     techniques designed to overcome several limits that have been reached with conventional~     high-frequency ultrasound systems. We propose that diagnosis of eye diseases using annular~     arrays can be more effective than the conventional ultrasound images by at least 50%; i.e.,~     that for every 2 posterior vitreous detachments detected conventionally, 3 will be detected~     with the annular arrays.~   "
223425|NCT00634218|"~     Smoking rates are significantly higher among lesbian, gay, bisexual, and transgender (LGBT)~     populations compared to the general population. LGBT individuals may be at increased risk for~     experiencing psychosocial issues, e.g., negative moods, stress, alcohol/drug use, that have~     been associated with smoking treatment failure in other groups of smokers. Technology, such~     as the Internet and telephone, can be an effective method to reach a large number of smokers~     and may be particularly effective in reaching hidden populations. Thus, the study seeks to~     examine whether Internet-based counseling and/or telephone counseling can improve quit rates~     for LGBT smokers.~      Participants (N=600) will be randomly assigned to one of four conditions: 1) a Mail-based~     Self Help (MSH) treatment; 2) MSH plus an Internet-based Smoking Treatment (IST); MSH plus~     Telephone Counseling (TC) or 4) MSH plus IST plus TC. Participants in the MSH condition will~     receive a self-help smoking cessation manual. In the IST condition, participants will receive~     the manual plus access to an Internet-based intervention that includes social support. In the~     TC condition, participants will receive the manual plus 6 telephone-based counseling~     sessions. In the fourth condition, participants will receive the manual plus access to an~     Internet-based intervention plus telephone counseling. Before starting treatment,~     participants will complete questionnaires on smoking, nicotine dependence, demographics,~     negative mood, and alcohol use. Participants will be contacted at 3, 6, and 12 months after~     enrollment to determine whether they are smoking. The data will be analyzed to compare the~     efficacy of the four treatments and to examine the possible influence of existing social~     networks and level of negative mood on treatment outcome and to examine the possible~     influence of residency (rural versus urban) on use of the Internet-based treatment.~   "
223426|NCT00634205|"~     The purpose of this study is to determine the response rate to the combination of doxorubicin~     and valproate acid in patients with MM failing after at least one previous chemotherapy~     regimen including platinum derivatives .~   "
223427|NCT00634192|"~     This study is designed to provide data about the pharmacokinetics (PK), safety and~     tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered~     via a 'soft mist' nebulizer in Cystic Fibrosis (CF) subjects. Each treatment period will last~     8 weeks. Additionally the PK of patients with a normal forced expiratory flow in 1 second~     (FEV1) (FEV1≥80% predicted) will be compared to patients with an abnormal FEV1 (FEV1<80%~     predicted).~   "
223428|NCT00634179|"~     This is an open-label (doctors and patients know which drug will be given), single center,~     phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides~     benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).~   "
223429|NCT00634166|"~     The primary objective is to compare the effectiveness of treatment with Sulfamylon® solution~     as the initial topical moist dressing over meshed autografts following the initial graft~     procedure on preventing graft loss in a prospective cohort of subjects versus a historical~     control group in a non-inferiority trial.~   "
223430|NCT00634153|"~     By placing the medical record information of many subjects into a research registry,~     researchers will be able to conduct research studies directed at increasing our knowledge~     about Gastrointestinal Diseases.~   "
223431|NCT00634140|"~     Ezetimibe is a drug which inhibits the absorption of both dietary and biliary cholesterol in~     the small intestine. Ezetimibe has been approved for use in humans to lower serum~     cholesterol.~      The primary aim of this study is to determine if ezetimibe normalizes resting and residual~     volume in patients with chronic acalculous cholecystitis.~   "
223432|NCT00634114|"~     The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once~     daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux~     esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily~     by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the~     treatment period (from the randomisation to the treatment completion) according to the Los~     Angeles classification.~   "
223433|NCT00634101|"~     This study seeks to evaluate the clinical performance of a new CE marked daily disposable~     contact lens that contains a wetting agent to a recently improved daily disposable contact~     lens.~   "
223434|NCT00634088|"~     The purpose of this study is to determine the safety and preliminary effectiveness of~     ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal~     growth factor receptor 2 (HER2)-positive or metastatic breast cancer.~   "
223435|NCT00634075|"~     The purpose of this study is to determine whether a fish oil-based lipid emulsion, enriched~     with ω-3 fatty acids, reduce proinflammatory cytokines and mortality rate in critically ill~     patients with severe sepsis.~   "
223436|NCT00634062|"~     This study investigates the hypothesis that instability in mood in patients with borderline~     personality disorder will respond the mood stabilizing medication lamotrigine.~   "
223437|NCT00634049|"~     The purpose of this study is to investigate the efficacy and safety of isavuconazole in the~     treatment of renally impaired participants with invasive fungal infections caused by~     Aspergillus and participants with invasive fungal disease caused by rare fungi.~   "
223438|NCT00634036|"~     Asthmatics who are significantly overweight tend to have more severe symptoms, more flare~     ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.~      Researchers believe this occurs because excess adipose tissue (fat) in the body can cause~     higher-than-normal levels of leptin and lower-than-normal levels of adiponectin in the blood.~      The researchers of this study are testing a medication called pioglitazone in overweight~     asthmatics because they believe it can help regulate leptin and adiponectin and that this may~     improve symptoms of asthma.~   "
223439|NCT00634023|"~     This is a cross-sectional study of symptom burden and clinical management. A subset of~     patients who have attended the Primary Care (PC) office with reflux symptoms during a~     retrospective period of 4 months (Index Visit) are invited to complete health survey~     questionnaires and partake in a subject-physician/study nurse interview (Visit 1), in order~     to assess the type, intensity and frequency of GERD symptoms at both visits and describe the~     treatment provided. Additionally, the impact of GERD on subjects' life, productivity and~     willingness to pay for GERD symptom relief will be explored. This design will give a~     real-life clinical practice picture in a representative population of PC doctors and~     subjects.~   "
223453|NCT00633841|"~     The purpose of this study is to assess the tolerability and safety of repeated subcutaneous~     injection of a single dose of AFFITOPE AD02 in patients with mild to moderate Alzheimer's~     Disease.~   "
223464|NCT00633698|"~     Lipoprotein (Lp)(a) has been associated with increased risk of cardiovascular disease. Niacin~     has been shown to lower Lp(a) in patients with normal or moderately elevated levels. However,~     there are few studies assessing the effectiveness of niacin in Lp(a) levels above 30 mg/dl.~     In addition, most studies investigating the effectiveness of niacin have only included small~     numbers of patients. Also, Lp(a) was only assessed as a secondary endpoint. The aim of the~     present study was, therefore, to evaluate whether Niacin is effective compared to placebo in~     the reduction of an elevated Lp(a).~   "
223440|NCT00634010|"~     Primary Aims:~        -  To determine whether methadone used as first line strong opioid is superior to morphine~          as evidenced by reduced pain over a 12-week treatment period in patients with advanced~          cancer. Previous studies have demonstrated consistent improvement of pain control after~          opioid rotation from morphine to methadone. In addition, the pilot study showed that~          there was a trend towards lower pain intensity when methadone used as first line opioid~          as compared to morphine. Researchers postulate that due to its superior analgesic~          effects, methadone will result in better pain control over time as compared to morphine.~        -  To determine whether methadone used as first line strong opioid is superior to morphine~          as evidenced by reduced frequency of neurotoxicity, dose escalation and treatment~          failure over a 12-week treatment period. Previous studies have demonstrated that~          patients develop increased pain or neurotoxicity after chronic use of morphine and~          require frequent opioid escalation. Researchers postulate that methadone will~          demonstrate lower opioid induced neurotoxicity, less frequent dose escalation and less~          treatment failure over 12-week treatment period as compared to morphine.~      Secondary Aim:~      -To perform an economic evaluation, comparing the costs and clinical benefits of methadone~     and morphine. Researchers will perform an evaluation that incorporates both treatment and~     potential downstream costs, as well as an examination of clinical benefits that incorporate~     preferences, to perform an appropriate economic comparison. We postulate that methadone and~     its associated costs will be cheaper than morphine. However, if one strategy is both more~     expensive and clinically superior than the other, researchers are prepared to perform an~     incremental cost-effectiveness analysis. In that case, researchers expect to show that the~     greater pharmaceutical costs involved with morphine will make its use not be a cost-effective~     strategy.~   "
223441|NCT00633997|"~     This study will look at the skin accumulation of vildagliptin and its two major metabolites,~     LAY151 and LAF237-O-Glucuronide, after vildagliptin 50 mg given orally twice a day for 10~     days in both healthy volunteers and patients with type 2 diabetes.~   "
223442|NCT00633984|"~     The purpose of this study is to test a drug called d-cycloserine to see if it can help people~     with a condition called social phobia. Social phobia is also called social anxiety~     disorder. Social phobia is a constant fear of social or performance situations. Social~     situations include group gatherings of any kind. Performance situations might include times~     when a person would have to do something in public, such as speak up in class or at a~     meeting. A person with this condition worries about being embarrassed, or about other~     people's opinions. People with social phobia usually feel extremely anxious (nervous and~     worried) about being the focus of attention. They often avoid social and performance~     situations. This behavior can have a negative effect on the quality of their lives and~     relationships.~      In this study, we want to find out if d-cycloserine can help control social phobia when the~     drug is added to the standard treatment for this condition. The standard treatment is~     cognitive-behavior therapy (CBT). CBT is a form of talk therapy involving discussion with a~     therapist, along with practicing the feelings or events that the person finds frightening.~   "
223443|NCT00633971|"~     The purpose of this study is to determine if complex lymphedema therapy is effective in~     decreasing disease severity and improving quality of life in patients with post thrombotic~     syndrome.~   "
223444|NCT00633958|"~     In spite of numerous advances in neuroimaging techniques, the diagnosis of pediatric brain~     tumors relies on the pathologic evaluation of material obtained at the time of the initial~     operation. While 18F-FDG-positron emission tomography (PET) helps identify higher-grade~     lesions due to their increased glucose metabolism, the high tracer uptake of the normal~     adjacent brains makes this modality of limited value. Fluorine-18 fluorothymidine (FLT) is a~     new imaging agent that has two significant advantages in the imaging of CNS tumors. First,~     this agent detects cellular proliferation directly, and second, the normal brain does not~     take up the agent, making a positive area(s) easy to identify. Before embarking on a large~     pediatric disease stratified assessment of FLT imaging in pediatric neurooncology patients,~     the investigators are proposing a limited patient pilot study to evaluate the~     biodistribution, dosimetry and specificity of this compound when compared to~     immunohistochemical assessment of mitotic activity in newly diagnosed patients undergoing~     surgical resection.~   "
223445|NCT00633945|"~     This study is being conducted to evaluate the safety and effectiveness of lenalidomide~     (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used~     in an off-label indication to treat 6 subjects for 12 months each. Men and women over the age~     of 18, who have a biopsy proven diagnosis of CLE and who have failed standard treatment, will~     be included in the study.~   "
223446|NCT00633932|"~     This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily~     for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in~     comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux~     Esophagitis at Week 8 according to the Los Angeles classification .~   "
223447|NCT00633919|"~     This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone~     Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma,~     based on asthma medication use during a period of 2 months with a high environmental exposure~     to mites (autumn 2008).~   "
223448|NCT00633906|"~     The Horizons Program will test the efficacy of a multi-session HIV prevention program for~     African American female teens attending reproductive health clinics in Atlanta, GA.~   "
223449|NCT00633893|"~     The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in~     preventing venous thromboembolic (VTE) recurrence or death in patients who have completed~     their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)~   "
223450|NCT00633880|"~     The purpose of this study is to see whether droxidopa is effective in treating symptoms of~     neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic~     Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta~     Hydroxylase deficiency.~   "
223451|NCT00633867|"~     The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it~     may have a bigger role than as a back-up to conventional direct laryngoscopy and could~     possibly be the first-line laryngoscope for situations where difficult intubations are more~     likely or more hazardous. The incidence of difficult or failed intubation for an individual~     anaesthetist is related to their experience, decreasing as experience increases. The purpose~     of this trial is to evaluate the McGrath laryngoscope when used by relatively inexperienced~     anaesthetists, who are those most likely to encounter difficulties.~      The null hypotheses to be tested is that there is no difference between the Macintosh and~     McGrath laryngoscope in terms of ease and success in intubation.~   "
223463|NCT00633711|"~     The main purpose of this study is to investigate if treatment of obstructive sleep apnea~     syndrome (OSAS) by continuous positive airway pressure (CPAP) given by a traditional CPAP~     device administering a fixed air pressure, or by one automatic CPAP device (Somnosmart2,~     Weinmann, Hamburg) administering variable pressures, have different effects on sympathetic~     nervous system tone (as reflected by urinary excretion of norepinephrine and its catabolite~     normetanephrine) and on blood pressure.~   "
223454|NCT00633828|"~     Objective:~      Prospective study regulation in bone mass, size, architecture, cortical, trabecular bone,~     soft tissues and risk factors for cardiovascular disease at growth. Determine regulation by~     environmental factors. Evaluate how training affects the skeleton, soft tissues and~     cardiovascular risk factors during growth Material/Methods: (i) 500 children in one RCT´s~     with or without intervention with physical activity (daily scholl physical education) from~     school start to college. Annual evaluations~      Importance:~      The investigators provide increased understanding of the pathophysiology of osteoporosis by~     determine the mineralization, size- and architecture development during growth and adulthood.~     Evaluate if intervention program with exercise increase bone strength, muscle mass and reduce~     fatness and risk factor for cardiovascular disease.~      Background:~      Skeletal growth and the age related bone loss determine who will get osteoporosis (and~     fractures), but not only bone mass, also skeletal architecture and bone quality influence~     bone strength. Regulation of the traits differs where hormones, genetics and environmental~     factors continuously influence the development with different effect during different ages.~     It is thus imperative to determine the regulators of the traits and evaluate if these can be~     modified during growth.~      Aim:~      Study regulation of bone mass, size, architecture, cortical, trabecular, axial and~     appendicular bone and soft tissue during growth and aging; evaluate risk factors for~     cardiovascular disease; determine importance of environmental factors and hereditary factors.~      Study Design/Method~      Bunkeflo Cohort:~      Prospective, controlled exercise intervention study annually following skeletal development~     in 500children from age 7.~      Importance:~      By evaluating skeletal mass/architecture separate we will increase the understanding of the~     pathophysiology of osteoporosis. The intervention study provide Evidence Based Information as~     regard the importance of physical activity during growth. The presented Strength Index, where~     we combine bone mass and skeletal architecture, may predict fractures better than only bone~     mass.~   "
223455|NCT00633815|"~     Fontan-palliated patients comprise an interesting group of single-ventricle patients who are~     dependent upon passive return of blood from the body to the lungs. Systemic venous pressures~     are therefore quite elevated, and one study demonstrated that venous capacitance was~     diminished. In addition, these patients have markedly diminished aerobic capacity (Max VO2).~     Although one recent study demonstrated that Fontan patients can increase their Max VO2~     through diligent cardiac rehabilitation, their ultimate results were still well below~     average.~      It has previously been described that normal, healthy subjects have decreased exercise~     performance in a supine vs upright position. However, due to high venous pressures and the~     need for systemic venous return to overcome gravity in order to perfuse the lungs, one might~     hypothesize that Fontan patients would have increased exercise performance in a supine vs~     upright position. The investigators are interested in studying this hypothesis.~   "
223456|NCT00633802|"~     Personality disorders are life-long maladaptive behavioral patterns. Borderline personality~     disorder (BPD) is the leading personality disorder encountered in clinical settings, often~     associated with tremendous distress. It is characterized by impulsivity, emotional lability,~     unstable interpersonal relationships, with particular sensitivity to abandonment. BPD~     patients are prone to self destructive behaviors and all too frequently attempt suicide. When~     in emotional turmoil, persons with BPD may also develop brief, transient psychotic states.~      Psychotherapy for BPD is a common treatment option, but it requires considerable time and~     specific personnel training, and is therefore not always feasible. Medical treatment is an~     efficacious alternative, however there is no concensus on drug selection. Some experts have~     suggested that medical treatment should be selected individually according to the subject's~     dominant clinical symptom. Several psychopharmacological groups have been proposed:~     Antidepressants, mood stabilizers, and several novel antipsychotic drugs. The latter are~     particularly promising since they may produce symptomaic improvement with fewer adverse~     effects. Risperidone has been shown in a few preliminary studies to be promising in the~     treatment of various BPD symptoms, but no controlled study has tested it yet. We propose to~     test the efficacy of risperidone in the treatment of BPD in a double-blind crossover design~     using both clinical and phsysiological measure.The main hypothesis is that risperidone will~     be efficient in alleviating BPD core and secondary symptoms.~   "
223457|NCT00633789|"~     The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder~     and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on~     treatment. Those in which it is unclear will be randomized to continue or withdraw treatment~     to determine whether that benefit is related to brivanib~   "
223458|NCT00633776|"~     The purpose of this study is to compare the effects of nebulized formoterol fumarate~     (Perforomist) to dry-powder inhaler formoterol fumarate (Foradil). Perforomist is a solution~     that is made into very fine spray (using a nebulizer) that is then breathed in over 10-15~     minutes. Foradil is taken in a single quick, deep inhalation.~   "
223459|NCT00633763|"~     The pancreas is an organ that plays major roles in the digestion of food. A part of the~     pancreas called islet beta-cells produces insulin, which regulates the amount of glucose (a~     sugar) present in the blood at all times. Type-1 Diabetes Mellitus (T1DM), an autoimmune~     disorder characterized by destruction of pancreatic islet beta-cells (the cells that produce~     insulin), affects at least a million individuals in the US alone. In T1DM, a type of white~     blood cells called T lymphocytes attacks and destroys the pancreatic islet beta-cells,~     leading to a loss of insulin, an increase in blood glucose, and a dependence on insulin~     injections for survival. Despite rigorous control of blood sugar, the majority of diabetic~     patients develop serious complications including retinopathy, nephropathy, neuropathy,~     microangiopathy and strokes.~      Non-invasive methods to monitor pancreatic beta-cell loss associated with type-1 diabetes~     mellitus (T1DM) could improve early diagnosis, provide tools to measure responsiveness to new~     therapies, and evaluate the efficiency of pancreatic transplantation and graft survival.~      Our goal is to develop a non-invasive PET-CT imaging method based on binding of a molecule~     (18F-fallypride) for tracking beta-cell loss during the progression of T1DM. In preliminary~     studies we demonstrated specific binding of 18F-fallypride to D2 receptors in rat pancreatic~     sections and we demonstrated that the loss of pancreatic beta cells in streptozotocin-treated~     rats was associated with a corresponding decrease in 18F-fallypride binding to pancreatic~     sections. A preliminary 18F-fallypride PET-CT study done by a collaborator in Ohio on a~     healthy volunteer, revealed 18F-fallypride-uptake by the pancreas that was distinguishable~     from surrounding tissues. Aim-1 of our project will measure the variability of 18F-fallypride~     PET-scanning of the pancreas in six healthy volunteers scanned twice with an interval of 4-6~     weeks. In Aim-2 of our project, we will compare fallypride PET-CT scans of 12 patients with~     long-standing T1DM (nearly all beta cells destroyed) with 12 age- and sex-matched healthy~     volunteers. If we are able to distinguish between the two groups, we will in future (a)~     optimize the method so as to be able to detect a 20-30% loss of beta cells, and (b) perform~     PET-CT studies in new-onset T1DM patients and in at-risk first degree relatives of T1DM~     patients.~   "
223460|NCT00633750|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with~     breast cancer that can be removed by surgery.~   "
223461|NCT00633737|"~     The purpose of this study is to investigate whether a stress reduction intervention prior to~     surgery can improve wound healing and recovery.The investigators hypothesise that patients~     who receive a psychological stress reduction intervention prior to surgery will report lower~     stress and higher perceived control, have lower stress hormones, better wound healing and~     better self-reported recovery than patients who receive standard care alone.~   "
223462|NCT00633724|"~     The purpose of this study is to evaluate the safety, tolerability, immune response and~     clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, TTK,~     VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.~   "
223465|NCT00633685|"~     Three hundred (300) male or female outpatients, over 18 years of age, will be enrolled in~     this study to determine whether fluoxetine can be used as a treatment for Posttraumatic~     Stress Disorder in soldiers recently returning from combat exposure. There will be two phases~     to the study. In Phase I Fluoxetine + usual psychological care will be compared with Placebo~     + usual psychological care over a 12-week period. Subsequently, in Phase II all subjects will~     be offered the opportunity to enroll in a 20-week open-label trial on Fluoxetine. If response~     is inadequate, adjunctive treatment with either buspirone or bupropion will be offered. The~     investigational drugs are Fluoxetine, Buspirone and Bupropion. All are commercially~     available.~   "
223466|NCT00633672|"~     Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This~     study looks at the treatment of these gastric ulcers with one of the three following~     treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine~     150 mg twice daily.~   "
223467|NCT00633659|"~     The purpose of this study is to evaluate the effects of Hemospan infusion on vascular~     reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic~     critical lower limb ischemia.~   "
223468|NCT00633646|"~     Current therapy recommendations suggest a low protein diet to preserve residual renal~     function (RRF) before the start of dialysis, but a higher protein intake during dialysis to~     prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low~     protein intake also during treatment with peritoneal dialysis (PD) would be safe and~     associated with a preserved RRF.~   "
223469|NCT00633633|"~     The goal of this behavioral research study is to learn if education and training about~     exercise can help to change the lifestyle of cancer survivors with symptoms of heart failure.~   "
223470|NCT00633620|"~     Narrow Band Imaging (NBI) with high-definition (HDTV) visualization has been implemented into~     GI endoscopy with the purpose to better highlight endoluminal pathological structures by~     improving their contrast. Previous studies from referral centers could not show significant~     differences in terms of colonoscopic adenoma detection rate, but either very high adenoma~     rates or some numerical differences suggested that some benefit may exist which may become~     evident with average adenoma rates and/or large case numbers.~      In a prospective randomized trial performed exclusively in a multicenter private practice~     setting involving 6 examiners with substantial life-time experience (>10.000 colonoscopies)~     1200 patients will undergo HDTV screening colonoscopy with either NBI or conventional imaging~     technique on instrument withdrawal. Primary outcome measure is the adenoma detection rate~     (ADR; i.e. number of adenomas per patient).~   "
223471|NCT00633607|"~     After informed consent, participants will be asked to complete a medical/family history~     questionnaire and provide a blood sample. Participants will also be asked for their~     permission for study investigators to access medical records and/or recontact them for~     updates to their medical and family histories. Data and biospecimens will be stored for~     potential future research projects.~   "
223472|NCT00633594|"~     This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib,~     and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell~     Lymphoma (MCL).~   "
223473|NCT00633581|"~     Fatigue is one of the most frequently observed symptoms for company workers, and oxidative~     stress is regarded as one of its cause. Vitamin C is a well-known antioxidant, and the~     investigators seek for evidence of the efficacy of high dose vitamin C parenteral supplement~     on fatigue symptoms of company workers after work.~   "
223474|NCT00633568|"~     The purpose of the present trial is to assess if induction concurrent chemoradiotherapy~     followed by consolidation chemotherapy will improve survival in comparison with the same~     chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.~   "
223475|NCT00633555|"~     Patients who have undergone in vitro fertilization (IVF) and produced four or less follicles~     or had four or less oocytes (eggs) retrieved are often referred to as poor responders. We~     will refer to these patients from this point forward as low responders to avoid using a~     potentially offensive label. We are currently using 2 different IVF medication protocols in~     our practice to treat low responder patients with infertility: the Microdose Leuprolide~     protocol and the Luteal Phase Ganirelix protocol. We would like to conduct a~     randomized-controlled trial and randomize patients to one treatment group or the other to~     determine which medication protocol is more effective in treating infertility in this group~     of patients.~   "
223476|NCT00633542|"~     This is randomized, multicentre study aimed to compare a standard maintenance therapy with~     Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in~     patients with multiple myeloma who responded to ThaDD induction therapy~   "
223477|NCT00633529|"~     To evaluate the safety of the proposed Phase II dosage of the investigational drug IMO 2055~     when combined with erlotinib and bevacizumab in patients with previously treated advanced~     NSCLC.~   "
223478|NCT00633516|"~     The incidence of malignant melanoma has increased dramatically in recent decades. In 1930,~     the lifetime risk of an individual in the United States developing melanoma was 1 in 1,500.~     This has been exponentially increasing over the years with the risk estimated to be 1 in 75~     in 2000 . According to the American Cancer Society, approximately 59,580 new cases of~     melanoma will be diagnosed in the United States in 2005 and about 7,770 people are expected~     to die of the disease.~   "
223492|NCT00633334|"~     Therapies involving the immune system have already shown great promise in early clinical~     trials for the treatment of renal cell carcinoma and melanoma. One of the great challenges~     now facing this field is to extend these findings to other cancers. Little is currently~     understood about the nature of the immune response to more common gastrointestinal cancers.~     The first goal of this proposal is to collect blood and tissue samples from patients with~     early or late stage gastrointestinal cancers. These samples will be evaluated to better~     understand the immune response to these two cancers. The second goal of this proposal is to~     evaluate the specimens of these patients for changes and genetic markers that correlate with~     the presence of cancer. The information gathered from these studies will directly enhance our~     ability to design, conduct and monitor novel immunotherapeutic protocols for the treatment of~     patients with gastrointestinal cancer.~   "
226743|NCT00589797|"~     The purpose of this study is to learn whether an investigational device called the Activ-L~     Artificial Disc is safe and effective in the treatment of degenerative disc disease of the~     lower (lumbar) spine.~   "
223479|NCT00633503|"~     Tissue transfer flaps are a method of moving tissue from a donor location to a recipient~     location. In the case of a free tissue transfer flaps, the blood vessels to the transferred~     tissues are detached and then re-attached to different arteries & veins at the recipient~     site. The process of reconstructive surgery using tissue transfer flaps allows for improved~     results in terms of functionality, aesthetic appearance, and psychological well-being in~     patients requiring reconstructive surgery after cancer resection or trauma. The process of~     reconstructive surgery using tissue transfer flaps is not without complications. These~     complications may include acute arterial or venous occlusion, as well as the development of~     late complications such as fat necrosis and flap atrophy.~      The purpose of this pilot study is to determine if a novel, unique, portable, non-contact~     optical imaging device developed at the Beckman Laser Institute called Modulated Imaging (MI)~     can detect changes in a flap's optical properties, which can correlate with arterial or~     venous occlusion or with the development of fat necrosis or flap atrophy. The study would~     also evaluate if changes in the tissue transfer flap's optical properties, as detected by the~     device could be employed as a monitoring device in the post-operative period after~     reconstructive surgery. The MI device's detection of specific optical properties of a tissue~     flap could also potentially be used as a diagnostic tool to predict the likelihood of the~     development of fat necrosis or flap atrophy in a delayed fashion several months after~     reconstructive surgery.~      Prior animal and clinical studies using similar devices have demonstrated that changes in the~     total hemoglobin concentration and percentage of oxygenated hemoglobin in the tissue transfer~     flap can be used to differentiate between arterial and venous occlusion. These other similar~     devices have been shown to be able to detect venous occlusion prior to clinical~     manifestations of venous occlusion using standard monitoring methods. This early detection of~     venous occlusion has important implications. It is well established that early detection and~     surgical re-exploration and correction of venous occlusion is associated with improved~     survival and salvage rates of tissue transfer flaps. It has been suggested in the~     reconstructive literature that the development of fat necrosis and flap atrophy are caused by~     a relative arterial or venous insufficiency, which could be detected using the MI device~     prior to the clinical manifestations of these complications.Patients undergoing~     reconstructive surgery at UCI Medical Center will be recruited for enrollment into the study.~     The study design requires following the patients and review their medical records in order to~     determine the clinical outcomes of their reconstructive surgery. The process of review of the~     medical record will require the review of both the in-patient medical record during the~     hospitalization in which the reconstructive surgery takes place and the outpatient medical~     record after surgery in order to observe for the possible development of the acute and~     delayed complications of reconstructive surgery.~   "
223480|NCT00633490|"~     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor~     receptor (VEGFR), so it can inhibit tumor angiogenesis. This phase I study aims to determine~     the drug's toxicity and to find a dose level to be used in a phase II study in solid tumor~     patients.~   "
223481|NCT00633477|"~     The purpose of this study is to determine the effect of resatorvid on subjects with sepsis.~   "
223482|NCT00633464|"~     The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and~     the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with~     triple negative (estrogen receptor [ER], progesterone receptor [PR], Human Epidermal Growth~     Factor Receptor 2 [HER2] negative) locally advanced non-resectable and/or metastatic breast~     cancer~   "
223483|NCT00633451|"~     The purpose of this randomized double-blind clinical trial is to determine the effectiveness~     of manual therapy for patients with subacromial impingement syndrome of the shoulder. We~     hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and~     spine will be more effective in reducing pain and shoulder disability at short-term (6 wk)~     and long-term (3, 6, 12 months) as compared to therapeutic exercise only.~   "
223484|NCT00633438|"~     To compare total analgesic use at 24 hours after arthroscopic knee surgery in~     celecoxib-treated versus placebo-treated patients~   "
223485|NCT00633425|"~     Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2~     diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.~   "
223486|NCT00633412|"~     Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This~     study looks at the treatment of these gastric ulcers with one of the three following~     treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once~     daily; or ranitidine 150 mg twice daily for subjects in the US only.~   "
223487|NCT00633399|"~     The purpose of this study is to see if adding the study drug, ziprasidone, to an~     antidepressant medication helps improve symptoms of Major Depressive Disorder (MDD). We are~     studying the drug's effectiveness in treating depression, as well as its safety when it is~     added to another drug.~      Hypothesis A: There will be a difference in the percentage of responders in the two treatment~     conditions during phase 2; response rates will be higher for the ziprasidone group.~   "
223488|NCT00633386|"~     To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients~     treated with celecoxib versus placebo.~   "
223489|NCT00633373|"~     Currently there are no approved therapies for lung transplant recipients in the United States~     (US). Treatment with CIS following lung transplantation has previously been demonstrated to~     result in a clinically meaningful improvement in survival and chronic rejection-free survival~     compared to placebo, but additional data supporting its use is needed prior to Food and Drug~     Administration (FDA) approval. This treatment use protocol is a mechanism for providing~     eligible lung transplant recipients early access to CIS in advance of FDA approval.~   "
223490|NCT00633360|"~     To determine if augmentation with the oral-contraceptive pill containing drospirenone and~     ethinyl estradiol is more effective than placebo in the treatment of premenstrual~     breakthrough of depression.~   "
223491|NCT00633347|"~     Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It~     is demonstrated that the use of hormonal substitution therapy, for the synchronization of the~     cycles between the recipients and the donors, provides good results, similar to the ones~     obtained with the natural cycle. In the patients - recipients with preserved ovarian~     function, the recipient's natural cycle is annulled, thus preventing the spontaneous~     Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her~     endometrium is prepared. When the donation occurs and fertilization with the husband sperm~     takes place, her cycle is stimulated again in order to synchronize her window of implantation~     with the donor's ovulation.~      Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa~     agonist or GnRH antagonists. The present study consists of the comparison between the single~     dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide~     0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation,~     administered in a single intramuscular injection (IM), which is more practical in terms of~     use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of~     GnRHa during the luteal phase and early gestation have questioned its use. The recovery of~     the Hypophysarian function begins only 8 weeks after the single injection of long liberation~     of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary~     inhibition shorter than with the analogues and can prepare similar endometrium~     characteristics as a natural cycle. The recipients will be assigned randomly to a group of~     treatment or another.~   "
224370|NCT00621621|"~     The purpose of this post approval study of heart block is to gather additional information~     regarding how often patients develop heart block (atrioventricular block) after having~     standard ablation procedure using cryotherapy with the Freezor™ catheter.~   "
223493|NCT00633321|"~     Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually~     from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of~     cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers;~     but for smokers who can quit there is an immediate and significant beneficial impact on their~     health and life expectancy. Cigarette smoking remains the leading preventable cause of death~     in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people)~     each year.~      This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC~     compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.~   "
223494|NCT00633308|"~     The purpose of this sudy is to determined the effect of dialysate volume and treatment time~     on phosphate and calcium removal in stage V chronickidney disease patients treated by~     hemodialysis using the System One (NxStage Medical, Lawrence, MA)~   "
223495|NCT00633295|"~     The mainstay of therapy for GISTs is surgical resection, however, recurrence is almost~     inevitable in high-risk tumors and secondary surgery or other salvage therapy has yielded~     poor outcome. The median survival for patients with unresectable or metastatic GIST is~     approximately 20 months, and for patients with local recurrence it is 9 to 12 months.~     Responses to chemotherapy have been at best 5%. The introduction of imatinib has dramatically~     changed the prognosis of these patients yielding response rates between 41% and 71% and an~     overall clinical benefit (tumor responses plus stable disease) ranging between 73% and 90%.~      However, resistance to imatinib may develop and represents a further clinical challenge.~     Sunitinib has recently been approved by the FDA for patients whose disease has progressed or~     who are intolerant to imatinib therapy. Patients with tumor progressing on sunitinib or~     another 2nd line agent have limited therapeutic alternatives. Reinstitution of imatinib, if~     possible, is considered an acceptable option for these patients because it may slow the rate~     of disease progression even in the setting of prior imatinib failure; however a more optimal~     3rd line treatment is needed. AMN107 is a novel aminopyrimidine, available as an oral~     formulation that is ATP -competitive inhibitor of BCR-ABL,more potent than Imatinib. It~     inhibits proliferation and autophosphorylation of 32 out of 33 BCR-ABL point mutations. In~     addition AMN107 also inhibits PDGFRα,PDGFRβ, and KIT. Preliminary data from an ongoing Phase~     I study in imatinib-resistant GIST patients (CAMN107A2103) indicate that AMN107 alone (400 mg~     BID) and in combination with imatinib (imatinib 400 mg BID plus AMN107 200 mg QD and 400 mg~     QD) is well tolerated in this pre-treated patients.~   "
223496|NCT00633282|"~     The purpose of this study is to evaluate the effects and safety of pioglitazone and berberine~     on the basis of lifestyle intervention to non-alcoholic fatty liver disease patients with~     impaired glucose regulation or type 2 diabetes mellitus.~   "
223497|NCT00633269|"~     Open, non-randomized, radiolabelled, single centre study designed to characterize the~     metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg~     [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid~     tumours.~   "
223498|NCT00633256|"~     A total of 20 subjects will participate in this four week, between groups, double-blind,~     placebo controlled study. Subjects will participate in two experimental sessions separated by~     approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or~     placebo combined with cue exposure. Several physiological and subjective outcome measures~     (e.g., heart rate, blood pressure, galvanic skin response) will be obtained during the~     sessions. Experimental sessions will last approximately 4.5 hours with follow-up sessions~     lasting approximately thirty minutes. Our aims are:~        1. To examine the effect of cycloserine vs. placebo on extinction of smoking cue reactivity~          in overnight abstinent smokers. Reactivity to smoking cues will be captured with~          self-report smoking urges and physiological measures (heart rate, blood pressure, and~          skin conductance).~           We hypothesize that cycloserine, relative to placebo, will facilitate extinction of~          smoking cue reactivity.~        2. To examine the effect of cycloserine vs. placebo when combined with two 4.5 hour~          laboratory cue exposure training sessions, on smoking behavior in smokers. Smoking~          behavior will be measured with self-report smoking and saliva cotinine levels.~        3. To examine the effect of cycloserine vs. placebo on memory performance in nicotine~          dependent smokers. Memory performance will be measured with verbal learning, recognition~          and recall tasks.~      4) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize~     that cycloserine will be well tolerated by smokers.~   "
223499|NCT00633243|"~     We hypothesize that integrating Hepatitis C into methadone and buprenorphine treatment will~     improve Hepatitis C outcomes as well as drug treatment outcomes in patients who are addicted~     to opiates. We will test this hypothesis by randomly assigning patients to receive integrated~     or separated care. The first group will receive Hepatitis C treatment and substance abuse~     treatment contemporaneously at the South Central Rehabilitation Center (SCRC). They will take~     both methadone or buprenorphine and Hepatitis C medications under the daily (methadone) or~     weekly (buprenorphine) observation of a health care provider. The second group will receive~     substance abuse treatment at SCRC, and go to another facility to receive Hepatitis C~     treatment services. These participants will take their medications on their own (without~     observation).~      We will look at outcomes such as Hepatitis C viral loads, adherence to medications, and drug~     treatment outcomes such as receipt of buprenorphine and methadone and urine toxicology~     testing.~   "
223500|NCT00633230|"~     The purpose of this study is to (1) determine the effects of the herbal formula Sho-saiko-to~     (SST) compared to placebo in treating hepatitis C virus (HCV) in persons who have not~     responded to the current conventional therapy (peginterferon alfa and ribavirin) or who have~     relapsed or in those for whom conventional therapy is contraindicated; (2) determine the~     influence that SST will have on participant reports of depression/sadness, fear and~     uncertainty related to the HCV disease progression, and renewal of hope in these individuals;~     and (3) collect preliminary data needed to examine feasibility, patient acceptance, and any~     potential limitations of the study.~   "
223580|NCT00632138|"~     RATIONALE: Personalized training by a health professional may improve urinary incontinence.~     It is not yet known whether pelvic floor muscle training and biofeedback are more effective~     than standard therapy in improving urinary continence after radical prostatectomy or~     transurethral resection of the prostate.~      PURPOSE: This randomized phase III trial is studying pelvic floor muscle training and~     biofeedback to see how well it works compared with standard therapy in men who have undergone~     radical prostatectomy or transurethral resection.~   "
223501|NCT00633217|"~     The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in~     subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC~     DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with~     chronic bronchitis in the US. This study will last up to approximately 15 weeks, and subjects~     will visit the clinic 5 times. Subjects will be given breathing tests and will record their~     peak expiratory flow measurements daily on diary cards. All study related medicines and~     medical examinations will be provided at no cost. The FSC HFA MDI used in this study has been~     approved by FDA for use in asthma while the FSC 250/50mcg DISKUS has been approved for use in~     asthma and COPD.~   "
223502|NCT00633204|"~     The purpose of this study is to evaluate the clinical efficacy for the prevention of the~     recurrence for bladder cancer after TUR-Bt~   "
223503|NCT00633191|"~     Hypothesis: Daily gargling with specific avian antibodies against Pseudomonas aeruginosa will~     prevent infections with this bacteria in patients with Cystic fibrosis (CF).~   "
223504|NCT00633178|"~     This study will evaluate the effectiveness of group interpersonal psychotherapy for~     preventing postpartum depression in pregnant women with depression and for improving healthy~     outcomes in their babies.~   "
223505|NCT00633165|"~     This is a Phase II, multicenter, open-label clinical trial designed to determine the efficacy~     and safety of Brostallicin when administered once every 3 weeks in patients with myxoid~     liposarcoma with (12;16) translocation. The primary objective of this study is to determine~     the response rate following Brostallicin administration.~   "
223506|NCT00633152|"~     The purpose of this study is to determine whether ceftaroline is effective and safe in the~     treatment of complicated skin and skin structure infections in adults.~   "
223507|NCT00633139|"~     This is a single center, open-label study of patients with late infantile MLD. All patients~     were previous treated 26 weeks in the phase I trial (EudraCT number: 2006-005341-11,~     NCT00418561). All patients will be offered continuing treatment in this study and will in~     this protocol receive 13 infusions, whereby the patients total have had 27 infusions of~     Metazym. One infusion will be given every other week. After a total of 52 weeks of treatment~     the subjects will continue treatment in a compassionate use protocol. Safety (AE/SAE) will be~     monitored at every visit.~   "
223508|NCT00633126|"~     The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric~     subjects~   "
223509|NCT00633113|"~     The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and~     cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally~     invasive knee joint replacement surgical techniques. The primary study hypothesis is that in~     comparing total knee replacement performed with the two different surgical techniques that~     respect four minimally invasive surgery principles (low-profile instrumentation, minimally~     invasive incision, overall minimal knee surgical intervention), a faster return to function~     will result when the technique does not incise the tendon.~   "
223510|NCT00633087|"~     Subjects will be asked to participate in this clinical trial to examine the safety of~     2-deoxyglucose (an agent which is quite similar to glucose) in the treatment of solid tumors~     and hormone refractory prostate cancer. This agent works by blocking the metabolism of~     glucose in the cells of the body. Although all cells require glucose for metabolism, it is~     believed that cancer cells require significantly more glucose than normal cells to grow.~     Therefore, even slight effects of glucose metabolism in cancer cells might result in the~     shrinkage of certain cancers. This agent has been given to humans before and has only caused~     mild nausea, vomiting and glucopenia (low blood sugar) at the doses given in these studies.~     This study will further examine the safety of 2-deoxyglucose in the treatment of advanced~     solid tumors and hormone refractory prostate cancer. The information obtained in this study~     will be used to design future clinical studies with 2-deoxyglucose. Subjects will be asked to~     take an oral solution of 2-deoxyglucose daily, by mouth, while on this study. They will be~     asked to have CT Scans, Bone Scans, and optional PET (Positron Emission Tomography) Scans~     prior to starting this study. PET scans will also be performed shortly after the start of the~     study and after 2 cycles (6 weeks) of therapy. Subjects will be asked to have a comprehensive~     physical examination and blood work prior to the start of the study. During the first 2~     cycles of the study subjects will be asked to have blood drawn at different time intervals~     for the first 2 days of each cycle. While on the study, they will be asked to return to the~     clinic at intervals of 1 week for a physical examination and blood tests. Subjects will also~     be asked to have CT Scans and Bone Scans at intervals of 9 weeks while on the study.~   "
223511|NCT00633074|"~     The purpose of this study is to show the non-inferiority of different formulations of~     GlaxoSmithKline Biologicials' influenza vaccine.~   "
223512|NCT00633061|"~     The primary hypothesis of this study is that occult catheter-related DVT in children with~     cancer is common and directly contributes to development of serious catheter complications,~     specifically bacteremia/fungemia and/or recurrent occlusion of the catheter tip. Accordingly,~     anticoagulant treatment of clinically silent (occult) DVT will reduce rates of~     catheter-related infection and occlusion, delays in therapy and need for catheter~     replacement.~   "
223513|NCT00633048|"~     This is the first time that NSA-789, a new compound being developed for schizophrenia, will~     be given to humans. Each healthy subject will receive a single dose, except for 8 subjects~     who will receive 2 doses-- one dose under fasting conditions and one dose after eating food.~   "
223549|NCT00632567|"~     Anal incontinence is frequent and treatment is difficult. One of the most important reasons~     is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This~     incidence is higher after second vaginal delivery, particularly if the first delivery caused~     break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean~     section. So, do the investigators have to recommend caesarean section for second delivery if~     the first was traumatic? But caesarean section had a morbidity. Actually, the choice between~     the delivery modalities is very subjective.~   "
223550|NCT00632554|"~     A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in~     the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may~     be as effective as 6 months-therapy.~   "
223581|NCT00632125|"~     Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of~     relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney~     Disease (CKD) subjects receiving HX575 epoetin alfa i.v.~   "
223514|NCT00633035|"~     Although stress ulcer is a complication that can cause mortality and morbidity in critical~     patients, there is still lack of consensus about its prophylaxis. There is also few data~     available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer~     sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia.~     Recently, proton pump inhibitors were shown to have good prophylactic effects for stress~     ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and the~     tablets are soluble for the use of tube feeding. Our previous study showed that there was no~     difference for the efficacy of stress ulcer prophylaxis between esomeprazole and sucralfate~     in patients admitted to medical ICU with at least one risk factor. The prevalence of~     nosocomial pneumonia was also similar.~      We will enroll those patients that have received intracranial surgery and admitted to~     neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7~     days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg qd~     from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the~     following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test,~     NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We~     define the end point as overt bleeding, death or transfer out of ICU. We will compare the~     prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.~   "
223515|NCT00633022|"~     This study is being conducted to assess the potential anti-inflammatory effects of a 3-month~     treatment with GW856553, on the inflammatory activity within the aorta and carotid plaques,~     as assessed by FDG-PET/CT.~   "
223516|NCT00633009|"~     The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of~     the product. This study has been designed to measure the skin test responses to 15, 30, or~     50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the~     antigen solution and the product's ability to sensitize lymphocytes of Leishmania naïve~     persons when administered intradermally. The presence or absence of a local inflammatory~     response to the first skin test with each of three doses of LtSTA will provide insight on the~     specificity of the antigen in a naïve population. The local inflammatory response to LtSTA~     following the first and second repeat skin tests will indicate if the antigen is sensitizing~     after intradermal administration.~   "
223517|NCT00632996|"~     The purposes of this study are to:~        1. determine if a rehabilitation program that consists of exercise and manual therapy~          reduces pain and improves quality of life in patients with shoulder subacromial~          impingement syndrome;~        2. determine which patients are likely to respond to this rehabilitation program and which~          patients are not likely to respond to this rehabilitation program~      The hypotheses are:~        1. the rehabilitation treatment program will result in significant changes in pain and~          quality of life~        2. there will be items from the history and examination that will identify those patients~          who respond favorably and those who do not respond favorably to rehabilitation at 6~          weeks, 3, 6 and 12 months.~   "
223518|NCT00632970|"~     This program is designed to study the efficacy, safety, lipid effects and tolerability of~     raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not~     received prior antiretroviral therapy. All patients will receive concomitant therapy with~     Truvada.~   "
223519|NCT00632957|"~     The purpose of this study is to test the hypothesis that dietary n-3 PUFA will have a~     beneficial effect on systemic and local markers of inflammation when combined with~     traditional, non-surgical periodontal therapy.~   "
223520|NCT00632944|"~     The purpose of this study is to determine the effects of hourly rounding on patient falls,~     patient satisfaction, and patient call light usage. This is a replication of research which~     determined that hourly rounds conducted by nursing personnel decreased patient falls and call~     light usage and increased patient satisfaction. The study design is quasi- experimental. One~     unit will be used as its own control (4S). On this unit, hourly nursing rounds will be~     implemented by Registered Nurses, Licensed Practical Nurses, and Nursing Assistants. A second~     unit, 6S, will maintain current practices and data from this unit will be used to determine~     if there are any hospital-wide fluctuations for fall rates, patient satisfaction, or call~     light usage. Data for patient falls, patient satisfaction, call light usage, and reasons for~     call light use will be collected on both units using fall rate reports, patient satisfaction~     survey data, and the call light system.~      Falls among hospital patients are a persistent problem, with 2.3 to 7 falls occurring in U.S.~     hospitals every 1000 patient days. Approximately 30-48% percent of these falls result in~     injury and 5 to 10 percent of them result in serious injury. Fall related deaths occurred at~     a rate of 46.2 per 100,000 in 2003. Hospital falls affect both young and old patients and~     many of them occur when the patient is alone or involved in elimination-related activities.~     Falls that result in injury may lead to an extended hospitalization and increased costs.~     Patients who fall and sustain injury are reported to have hospital charges of more than~     $4,200 higher than patients who do not fall. Hourly nursing rounds have been shown to~     decrease falls by 52%.~      Hospitalized patients often require assistance with basic self-care tasks, such as using the~     toilet, ambulating, and eating; they ask for assistance by using the call light. Therefore, a~     patient's level of satisfaction with nursing care depends principally upon the patient's~     perception of how well the nursing staff has been able to meet his or her needs. The call~     light can be a lifeline for hospitalized patients, but it can also impose considerable~     demands on nurses' time. Several studies have documented the unfavorable effects of patients'~     frequent use of call lights on the effectiveness of patient-care management on inpatient~     units, which may already be compromised by staffing shortages.~   "
223521|NCT00632931|"~     A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval~     in patients with relapsed or refractory advanced cancer.~   "
223522|NCT00632918|"~     The purpose of this study is to investigate the effects of heart rates (including maximum~     heart rate, average heart rate and minimum heart rate) and variability of heart rate on image~     quality of DSCT coronary angiography without control of heart rate experienced in our~     department.~   "
223523|NCT00632905|"~     Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral~     Density (BMD). Using a prospective, observational study design, we propose that monitoring~     how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold~     standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study~     will provide some of the first prospective data on the rates of Skeletal Related Events~     (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the~     use of DEXA screening for prostate cancer patients.~   "
223524|NCT00632892|"~     Clinically, iodinated contrast-medium (CM) is widely used in angiography and computerized~     tomography. CM-induced nephropathy (CMIN) is one major complication after application of CM.~     Therefore, how to prevent CMIN is always one of the hot topics concerned by nephrologists,~     cardiologists, and radiologists.~      The present study is aimed to determine the norepinephrine concentration, oxidative markers,~     and tubular damage markers in the urine samples of patients undergoing intravenous~     pyelography (IVP).~      The working hypothesis is high-osmolarity contrast media (HOCM) causes more oxidative stress~     and greater tubular damage than iso-osmolarity contrast media (IOCM).~   "
223525|NCT00632879|"~     Metabolic syndrome (MS), comprised of central obesity, glucose intolerance, hyperinsulinemia,~     low HDL-cholesterol (HDL-C), high triglyceride (TG) and hypertension, results in markedly~     increased risk for cardiovascular disease in the general population. The National Cholesterol~     Education Program Adult Treatment Panel III (NCEP ATP III) report recommended the use of five~     variables for the diagnosis of the MS including waist circumference (WC), serum TG~     concentration, serum HDL-C concentration, blood pressure and fasting glucose concentration. A~     waist circumference of 80 cm in women and 90 cm in men would better identify those with the~     MS in Asian populations. However, the studies of modified asian criteria of metabolic~     syndrome in hemodialysis (HD) patients are scarce.~      We will perform prevalence investigation, cross-sectional study, and prospective~     investigation for metabolic syndrome in our HD patients (around 360 at present). We will~     enroll all the patients who receive maintenance HD more than three months in our HD center.~     The patients who are hospitalizing, suffered from active malignancy, active infections,~     recent cardiovascular events and surgery will be excluded in the beginning of study.~     Biochemistry and anthropometric parameters including HDL-C, TG, insulin resistance index,~     high sensitivity C-reactive protein and WC will be collected and analyzed. We will also~     prospectively establish the mortality and hospitalization indices of these patients, to study~     the prognosis of HD patient with or without metabolic syndrome.~      This study will be helpful to understand whether the application of a modified criteria of~     metabolic syndrome in HD patients is capable to predict cardiovascular events,~     hospitalization and mortality rates.~   "
223526|NCT00632866|"~     Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune~     disease systemic is characterized by disabling dryness, fatigue and pain, and systemic~     complications in 30% of patients. No treatment has proven effective in this disease. In open~     studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has~     ever been done.~      Thus, the primary purpose of this study is to evaluate the efficacy and safety of~     hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using~     visual analogical scales.~   "
223527|NCT00632853|"~     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,~     such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet~     known which radiation therapy regimen is more effective when given together with chemotherapy~     in treating patients with limited-stage small cell lung cancer. This randomized phase III~     trial is comparing different chest radiation therapy regimens to see how well they work in~     treating patients with limited-stage small cell lung cancer.~   "
223528|NCT00632840|"~     The purpose of this study is to determine whether atorvastatin and fenofibrate are effective~     in the treatment of lipid disorders in obese, insulin resistant subjects.~   "
223529|NCT00632827|"~     This study examines the use of denileukin diftitox (Ontak) for patients with peripheral~     T-cell lymphoma who are candidates for autologous stem cell transplants.~   "
223530|NCT00632814|"~     A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on~     bleeding events frequency and development of arthropathy in Previously Treated and Minimally~     treated Hemophilia A pediatric population.~   "
223531|NCT00632801|"~     The incidence of ileus after laparoscopic colectomy continues to pose complications for the~     patient, staff, and the healthcare system. Postoperative ileus remains a source of morbidity~     and a major determinant of length of stay after abdominal surgery. Clinicians have devised~     strategies that minimize postoperative ileus. Gum chewing, an inexpensive intervention, is~     theorized to activate the cephalic- vagal reflex and increase the production of~     gastrointestinal hormones associated with bowel motility. Four studies examining gum chewing~     as an intervention to prevent ileus were found. These relatively few studies have~     demonstrated inconsistencies. Because of the small sample size of the four studies and the~     inconsistencies of the results, there is not enough evidence to change practice. There are no~     indications of risks associated with gum chewing as an adjunct therapy along with standard~     postoperative interventions. The purpose of this prospective, randomized control study is to~     examine if chewing gum in adult patients after elective laparoscopic colectomy decreases~     ileus compared with standard post-operative care.~      Patients will be randomized by weeks admitted and the patients in the gum chewing group~     (intervention group) will chew one stick of gum the first post-operative day, after the~     nasogastric tube is removed or if they patient does not have a nasogastric tube, with the~     head of bed elevated a minimum of 30 degrees for 30 minutes, three times a day at set~     intervals: 0900, 1400, and 2100. The gum will be kept in the Accudose cabinet and distributed~     by the medication nurse. The gum chewing regimen will continue until the first bowel~     movement. All patients in the non-intervention group will receive standard preoperative and~     postoperative regimens.~      Patient demographics that will be collected include gender, age, current medical condition,~     pre-operative medications, type of surgery, operative duration in minutes, anesthesia~     duration in minutes, estimated operative blood loss, whether they had an epidural or a PCA,~     date and time nasogastric tube was discontinued, length of stay, date of discharge,~     complications, and whether or not they had an ileus. Patients (if appropriate) and nurses~     will be instructed on how to complete the bedside bowel record to the nearest hour.~   "
223532|NCT00632788|"~     This study was designed to investigate the influence of the acute myocardial infarction~     checklist on the door-to-balloon time in patients suffering from acute STEMI at Far Eastern~     Memorial Hospital~   "
223533|NCT00632775|"~     The primary objective of this study is to compare the mean serum sodium at 48 hours following~     the initiation of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in~     children requiring maintenance IV fluid administration.~   "
223534|NCT00632762|"~     This is a French national trial, conducted using a double-blind, placebo-controlled,~     randomised design involving 7 centers and 80 patients of both sexes.~      The primary objective of the trial is to evaluate the effects of the interruption of a long~     term treatment (ex. Greater than 6 months) with Amantadine (prescribed as an antidyskinetic)~     in patients suffering from Parkinson disease being treated with Levodopa and suffering from~     mid dose dyskinesias.~      Secondary objectives of the trial are the evaluation of the other effects of withdrawal of~     Amantadine on the same group of patients: motor fluctuations, vigilance, apathy, fatigue,~     certain cognitive aspects, the disappearance or development of undesirable side effects and~     quality of life.~   "
223535|NCT00632749|"~     Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in~     combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML)~     patients~   "
223536|NCT00632736|"~     To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with~     early and advanced Parkinson's disease~   "
223551|NCT00632541|"~     Prior clinical trials involving bevacizumab and sorafenib have demonstrated single agent~     activity in previously treated advanced breast cancer. This trial will test combined VEGF~     inhibition with sorafenib and bevacizumab in less heavily pre-treated patients with advanced~     breast cancer.~   "
223537|NCT00632723|"~     This is a phase II trial to assess whether IRESSA™ (gefitinib) has anti-tumour efficacy in~     patients with breast cancer. The trial proposes to enter 27 patients who have acquired~     resistance to tamoxifen and 27 patients with ER negative tumours. However for each of these~     two types of patients recruitment will stop after 14 patients have been entered in order to~     confirm that IRESSA™ (gefitinib)has anti-tumour efficacy. If no patient out of 14 in a group~     has shown clinical benefit (ie an objective response (CR or PR) or stable disease (SD) for at~     least 24 weeks) then a clinical benefit rate of >20% can be ruled out with >95% certainty. If~     one or more of the objective response or stable disease (> 24 weeks) has been seen in the~     first 14 patients recruited in a group then recruitment to that group will recommence to a~     total of 27 patients. If 14 patients are entered into an arm but not all 14 patients are~     available for final analysis and the toxicity/safety and tolerability profile of the therapy~     is acceptable and documented and a clinical benefit is seen in the patients, enrolment of~     additional patients beyond the initial 14 may be made based on overall clinical assessment.~   "
223538|NCT00632710|"~     The purpose of the present study was to assess the effectiveness of low-level laser therapy~     on the reduction in pain and improvement in function in the hands of patients with rheumatoid~     arthritis~   "
223539|NCT00632697|"~     To prove efficacy of an immunomodulator called pentoxifylline in the treatment of~     endometriosis in infertile patients undergoing laparoscopy surgery~   "
223540|NCT00632684|"~     This study will develop and evaluate the effectiveness of an adaptive treatment model for~     reducing the stress of, and burden on, family members caring for a person with dementia.~   "
223541|NCT00632671|"~     The objective of the project is the constitution of a population-based cohort of 500 persons~     with severe or morbid obesity (BMI over 35 kg/m2) with annual follow-up for 10 years. It aims~     to improve the physiopathological, epidemiological and prognostic knowledge of obesity and~     its consequences. Clinical data, biological material, exams and questionaires will be~     collected and stored, allowing the realisation of research works, initiated by research teams~     from our hospital or from other settings.~   "
223542|NCT00632658|"~     Chronic Graft-versus-Host Disease (cGVHD) is an important cause of morbidity and mortality in~     patients undergoing allogeneic bone marrow transplantation. cGVHD usually occurs after 100~     days following transplantation and develops in 20-60% of transplant recipients. The incidence~     of cGVHD varies depending on the age of the marrow recipient, the use of sibling or unrealted~     donor bone marrow, teh use of unmanipulated T cell-depleted bone marrow, and perhaps other~     factors. Clinically, cGVHD is characterized by multi-system disease, which frequently mimics~     the clinical features of autoimmune diseases. The manifestations include skin changes~     (lichenoid and sclerodermatous changes, changes in pigmentation, loss of accessory structures~     such as hair, dystrophic nails, and rash), joint contractures, severe cramping, hepatic~     dysfunctions, sicca syndrome, obstructive lung disease, esophageal dysmotility, weight loss,~     polyserositis, immunodeficiency, and autoantibodies including anti-nuclear antibody,~     anti-erythrocyte antibodies, and anti-platelet antibodies.~   "
223543|NCT00632645|"~     Huntington's disease (HD) is autosomal dominant neurodegenerative disease, starting in~     average (with high variability) in the fourth decade. The disease progression is classically~     characterized by a cognitive deterioration (cortical-frontal dementia), motor disorders~     (associating chorea, dystonia and bradykinesia), psychiatric disturbances (combining~     depression and irritability) and metabolic disorder (cachexia). The disease is fatal within~     15 to 20 years in most patients. HD has no cure. Neuroleptics are the main drug used and the~     only to demonstrate its efficacy on chorea in clinical trials. But neuroleptics have also~     beneficial and adverse effects on other disease characteristics (motor, psychiatric,~     cognitive or metabolic). Their profile between beneficial and adverse effects could be~     different according the neuroleptics and their classification. The aim of this study is to~     compare beneficial and adverse effects of 3 different neuroleptics in HD.~   "
223544|NCT00632632|"~     This study proposes to evaluate the effects of D-cycloserine (DCS) combined with Virtual~     Reality exposure therapy in a sample of patients who developed posttraumatic stress disorder~     (PTSD) following either the events of September 11, 2001, or military service in the war in~     Iraq. In addition, this study hopes to determine whether a common human genetic single~     nucleotide polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF~     (Val66Met), predicts treatment response to PTSD.~      Overall, this study aims 1) to determine if subjects administered DCS show a significantly~     larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to~     determine if subjects administered DCS show a decrease in PTSD symptomatology significantly~     earlier (as measured by weeks) than those administered a placebo, 3) to determine if~     differences in symptomatology are evident at a 6-month follow-up and indicate long-term~     differences between groups, and 4) to determine if the BDNF SNP predicts treatment response.~   "
223545|NCT00632619|"~     This study will evaluate the effectiveness of an integrative group psychosocial therapy~     combined with stimulant medication in treating children with attention deficit hyperactivity~     disorder plus impairments in mood.~   "
223546|NCT00632606|"~     The study will compare effectiveness of intravenous magnesium sulfate to that of intravenous~     metoclopramide (Reglan®) for acute headache in pregnant women. We will randomize pregnant~     women who present to our emergency department with chief complaint of headache to magnesium~     sulfate 2 grams intravenously or metoclopramide 10 mg intravenously; both groups will receive~     acetaminophen (Tylenol®) 1 gram orally and normal saline 1 liter intravenously. Headaches are~     common during pregnancy, related to hormonal changes, altered sleep patterns and psychosocial~     stressors. Common medications for headache such as non-steroidal antiinflammatories or~     triptans are typically avoided during pregnancy due to concern for fetal effects. Women, and~     their physicians, are often uncertain regarding available medication options with justifiable~     safety profiles during pregnancy.~   "
223547|NCT00632593|"~     The purpose of this study is to define and evaluate the early complications between two~     different surgical techniques used to perform a laparoscopic gastric bypass~   "
223548|NCT00632580|"~     The purpose of this study is to evaluate the optimal site for application of local~     anesthetics in total knee arthroplasty surgery. The hypothesis is, that improved pain relief~     is obtained when administering local anesthetics in the tissues sourrounding the knee joint~     compared to the knee joint itself.~   "
223552|NCT00632528|"~     Children with cerebral palsy commonly undergo multilevel surgery, meaning several lower~     limb combined procedures performed during the same surgical intervention. The aim of this~     type of surgery is to correct all deformities together in order to restore near to normal~     anatomy and muscular function. It is very important to be able to obtain good range of motion~     after surgery, in order to consolidate surgical results. During the first days after the~     operation, children are sore and it may be difficult to realize adequate physical therapy. In~     order to palliate this situation, MEOPA gaz is used during REHAB sessions. Good results have~     been obtained so far but no study is available to demonstrate these results. The goal of our~     research is to prove that there is a benefit in using MEOPA postoperatively in these~     patients.~   "
223553|NCT00632515|"~     The goal of this psychosocial research study is to learn about the knowledge, beliefs, and~     attitudes that people have toward screening for colorectal cancer. Another goal is to study~     how families communicate about colorectal cancer risk and colorectal cancer screening, with~     each other and with health care providers.~      Objectives:~        1. To evaluate psychosocial and external factors influencing colorectal cancer (CRC)~          patients' communication with their first-degree relatives (FDRs) about CRC risk and~          screening information.~           Using measures of knowledge, health beliefs and behavior, family closeness, openness and~          motivation to discuss CRC and screening, distress, provider support and background~          variables (sociodemographics, access to care, and medical history), we will conduct a~          cross-sectional study to evaluate factors influencing CRC patients' communication about~          CRC risk and screening information to their FDRs.~        2. To evaluate psychosocial and external factors associated with CRC screening behavior~          among first-degree relatives of CRC patients.~      Using measures of knowledge, health beliefs and behavior, family closeness and subjective~     norms, distress, provider interactions, benefits/barriers, and background variables~     (race/ethnicity, sociodemographics, access to care, and medical history), we will conduct a~     cross-sectional study of FDRs of CRC patients recruited under Aim 1 to evaluate factors~     associated with CRC screening behavior (specifically, colonoscopy adherence).~   "
223554|NCT00632502|"~     4-Week Safety Study in Subjects with Neutrophilic Asthma~   "
223555|NCT00632489|"~     This single center Phase I dose escalation trial will evaluate the safety, tolerability and~     efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1 will~     determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine. Parts~     2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+~     overexpression or FISH amplification documented locally. Part 2 will evaluate the safety of~     the MTD of LBH589 determined in Part 1 when paired with lapatinib 1000 mg by mouth (PO)~     daily. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer~     patients, ICH 3+ overexpression or FISH amplification documented locally. Part 3 will~     evaluate the tolerability and effectiveness of the triplet combination, LBH589, capecitabine~     and lapatinib in breast cancer patients.~   "
223556|NCT00632476|"~     Women who smoke during their pregnancy place their unborn child at an increased risk of~     health problems, including decreased lung function and possible lung diseases later in life.~     Preliminary animal research suggests that if vitamin C is taken during pregnancy, nicotine's~     harmful effects on the unborn baby's developing lungs may be blocked. This study will~     determine the effect that vitamin C has on the lung development and function of babies born~     to women who smoke during pregnancy.~   "
223557|NCT00632463|"~     RSV infections can develop into serious, life threatening conditions among immunocompromised~     patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of~     RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients~     identified as being infected with RSV in the upper respiratory tract.~   "
223558|NCT00632450|"~     The EnSite Real-Time Cardiac Performance Measurements Study (EnSite RT CPM) is a multicenter,~     international, acute, non-significant risk study, designed to enroll a maximum of 40 patient.~     The goal of the study is to collect 3-D systolic/diastolic data with the EnSite NavX Mapping~     system during a CRT implant.~      Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite~     NavX Mapping system during the implantation of a cardiac resynchronization therapy device.~   "
223559|NCT00632437|"~     The goal of this proposal is to test the performance of a novel optical imaging system for~     real-time quantitative imaging of brain function through multiple hemodynamic measures during~     neurosurgery.~      This pilot study encompasses two sub-aims:~        -  Evaluate the ability of laser speckle contrast imaging to image cerebral blood flow~          (CBF) intraoperatively. We will image the changes in CBF in response to somatosensory~          stimulation. (5 patients).~        -  Simultaneously image hemoglobin oxygenation, blood volume, blood flow, and cerebral~          metabolic rate of oxygen (CMRO2) changes during somatosensory stimulation using a~          combined laser speckle and multi-wavelength reflectance imaging system. (5 patients).~   "
223560|NCT00632424|"~     This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21~     days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and~     safety of this dosing schedule in participants with advanced cancer~   "
223561|NCT00632411|"~     Rates of cigarette smoking in the military are high. Tobacco telephone quit lines are~     telephone-based services that provide information and guidance to people who want to quit~     smoking. This study will evaluate the effectiveness of a tobacco quit line program, in~     addition to nicotine replacement patches, at helping people in the military quit smoking~     cigarettes.~   "
223562|NCT00632398|"~     RATIONALE: A multimedia education program for family caregivers that teaches simple methods~     of touch and massage for the comfort of cancer patients at home may be effective in lowering~     stress, reducing symptoms, and improving quality of life for patients; and may improve~     caregiver satisfaction and self-efficacy.~      PURPOSE: This randomized phase II trial is studying how well multimedia instruction of~     caregivers in use of touch and massage works for cancer patients and their care partners.~   "
223563|NCT00632385|"~     To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were~     not satisfied with rizatriptan therapy~   "
223577|NCT00632203|"~     The main objective of this study is to investigate whether administration of maintenance~     temozolomide following standard treatment could possibly prevent or delay the onset of brain~     metastases in patients with controlled non-small cell lung cancer (NSCLC).~   "
223564|NCT00632372|"~     The purpose of this study is to collect and analyze electrical measurements, timing, and~     signals from a CRT-D device in heart failure patients who either already have an implanted~     left atrial pressure sensor or will undergo a simultaneous implantation of a left atrial~     pressure sensor and a CRT-D device. These devices may be placed at the same time or~     separately (staged procedure) at the discretion of the investigator. A comparison will be~     made between the information gathered from the CRT-D system and the information gathered by~     the left atrial pressure sensor.~   "
223565|NCT00632359|"~     The goal of this clinical research study is to learn if Revlimid (lenalidomide) can help to~     reduce the level of leukemia in your body. The safety of this drug will also be studied.~   "
223566|NCT00632346|"~     The purpose of this study is to determine if there is an association between a variety of~     adverse childhood experiences and overweight and obesity. The adverse childhood experiences~     that will be examined include childhood abuse (physical, emotional, sexual), childhood~     neglect (physical, emotional), and household dysfunction (domestic violence, parental marital~     discord, and household members with a history of substance abuse, mental illness, and~     criminal behavior). Because this study will be performed at a military treatment facility,~     additional military unique experiences to include frequent residential mobility and parental~     deployment will also be examined.~      Hypotheses/Research Questions: Overweight and obese young adults are more likely to report~     having experienced adverse childhood experiences and household dysfunction than their peers~     of normal weight. In addition, the more severely overweight or obese the patient, the more~     likely the patient is to report a higher number of previous adverse childhood experiences.~     Thus, there is a graded relationship between the severity of overweight/obesity and the~     number of adverse childhood experiences.~   "
223567|NCT00632333|"~     The purpose of this study is to evaluate the safety and immune response of multiple peptides~     (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in combination with~     chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable,~     advanced or recurrent esophageal cancer.~   "
223568|NCT00632320|"~     To compare the rapid shallow breathing index (RSBI) values, the incidence of adverse~     reactions, and the predictive accuracy measured under 5 different ventilator strategies in~     the same patient group.~   "
223569|NCT00632307|"~     Recognition of disease specific clusters of volatile organic compounds in patients with~     different lung diseases, using breath analysis with ion mobility spectrometry. Lung diseases~     of interest are:~        -  COPD~        -  tumors~        -  airway infection~        -  interstitial lung disease~        -  sleep apnea Hypothesis: Breath analysis with ion mobility spectrometry can differentiate~          pulmonary disorders.~   "
223570|NCT00632294|"~     Primary Objectives:~        1. To evaluate the material properties, histomorphometric indices, bone mineral density~          (BMD), and presence of microfractures in retrieved large allograft cortical bone~          specimens removed from orthopaedic oncology patients.~        2. To correlate physical properties to patient demographics and medical treatment received.~   "
223571|NCT00632281|"~     The purpose of this research study is to determine if Stereotactic Body Radiation~     Therapy(SBRT) is a good way to treat tumors near the thorax. Stereotactic Body Radiation~     Therapy (SBRT) is a general term for a group of techniques that are designed to deliver~     radiation therapy in a way that damages normal tissues less than conventional radiotherapy.~     The two features that distinguish SBRT from conventional therapy are procedures that decrease~     errors in patient positioning and technology that results in a radiation dose distribution~     that conforms more tightly to the tumor target. Patients will receive either 48 Gy or 60 Gy~     fractions depending on the type of tumor. The majority of patients will be treated in 1 week,~     Monday through Friday, with Wednesday off.~   "
223572|NCT00632268|"~     The primary end-point of this study is to evaluate the objective response rates, and the~     secondary end-points are overall survival, progression-free survival and safety profile of~     low-dose RAD001 (everolimus) plus cisplatin and HDFL (weekly 24-hour infusion of high-dose~     5-FU and leucovorin) chemotherapy in the first-line treatment for patients with unresectable,~     recurrent, or metastatic gastric cancer.~   "
223573|NCT00632255|"~     Imatinib has revolutionised the treatment of chronic myeloid leukaemia (CML). The first~     clinical trials were conducted in 1998 in patients with advanced disease, and by 2002~     imatinib was established as the standard therapy for all patients including those recently~     diagnosed. In spite of overwhelming evidence about its efficacy we still need to gain more~     knowledge about issues related to long term treatment with imatinib such as why some patients~     respond better than others, the development of side effects and the quality of life.~   "
223574|NCT00632242|"~     To evaluate the overall safety and tolerability of ARC1779, a therapeutic oligonucleotide~     (aptamer) in patients with three types of von Willebrand Factor related platelet disorders.~   "
223575|NCT00632229|"~     Obsessive-compulsive disorder (OCD) is a common, chronic, and oftentimes disabling disorder.~     The only established treatments for OCD are a specific form of Cognitive Behavioral Therapy~     (CBT) and the Serotonin Reuptake Inhibitor medications (SRIs). Few patients with OCD~     experience complete symptom resolution with either modality and even after two consecutive~     SRI trials, as many as 30%-40% of patients fail to derive a satisfactory response.~     Pharmacological options for these SRI-resistant cases include switching to a different~     antidepressant, increasing the dose of SRI, or augmentation with another agent.~      Previous studies showed that approximately 33-50% of OCD patients who have not had an~     adequate response to SRI medication had a positive response when an atypical antipsychotic~     medication was added. However, the problematic acute and long-term side effects of these~     medications are of concern and, at times, limit their use. Paliperidone has a number of~     advantages over these medications including fewer drug interactions and better tolerability.~     Thus, this study is designed to determine whether paliperidone augmentation of an existing~     medication is effective relative to taking a placebo and your existing medication.~   "
223576|NCT00632216|"~     The study in the labeled and real conditions of prescription of Actonel will investigate the~     satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also~     measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12~     weeks of treatment with risedronate 35 mg Once A Week.~   "
227131|NCT00584506|"~     A retrospective review to assess the performance and clinical predictive value of a novel~     software program (Maxillo) designed to perform complex volumetric analysis with application~     in the field of orbital trauma.~   "
223582|NCT00632112|"~     Continuous albuterol has become the standard of care for patients in status asthmaticus. We~     have previously performed an in-vitro study comparing 4 different brands of continuous~     nebulizers. We now want to compare the in-vitro with the in-vivo performance of the brand we~     use. we hypothesize that there will be no difference between in-vivo and in-vitro results.~   "
223583|NCT00632099|"~     The purpose of this pilot treatment trial is to evaluate the efficacy of oral micronized PROG~     in cocaine-dependent women. Since we have shown (Evans & Foltin, 2006) that oral micronized~     PROG attenuates the positive subjective effects of smoked cocaine in females, but not in~     males, and we have preliminary data indicating that oral micronized PROG also reduces smoked~     cocaine self-administration in the laboratory, PROG appears to be an ideal potential~     candidate medication to evaluate in cocaine-dependent women. Prior to randomization to~     treatment, women will reside inpatient for one week to ensure cocaine abstinence since one of~     the primary outcome measures will be time to cocaine relapse.~   "
223584|NCT00632086|"~     Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg~     with respect to salicylic acid.~   "
223585|NCT00632073|"~     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government~     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5~     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells~     that fight infection). Previous studies in HIV treatment-experienced patients have shown that~     vicriviroc is safe and effective. The purpose of this study is to determine the effect of~     vicriviroc on HIV RNA levels in cerebrospinal fluid (CSF).~   "
223586|NCT00632060|"~     The specific aims of this research project are to determine feasibility of, and the~     comparative treatment effect size for, conducting a larger clinical trial of~     Manual/Manipulative Therapy (M/MT) in restoring peak performance in military personnel in~     operational environments and to evaluate the ability of the addition of M/MT to standard care~     to decrease pain and increase function for patients with low back pain.~      The following two hypotheses will guide the data collection:~        1. The primary hypothesis is that the addition of acourse of M/MT to standard care for low~          back pain will decrease pain at 4 weeks when compared to standard care alone~        2. In addition, the secondary hypothesis will be that the addition of a course of M/MT to~          standard care for low back pain will decrease pain and increase function over 2 and 4~          weeks when compared to standard care alone~   "
223587|NCT00632047|"~     RATIONALE: Health education programs and screening methods, such as clinical breast~     examination and examination of the cervix, may help reduce the number of women who develop~     breast cancer and cervical cancer.~      PURPOSE: This randomized clinical trial is studying the early detection of breast cancer and~     cervical cancer in women in India.~   "
223588|NCT00632034|"~     The aim of this trial is to determine the safety and tolerability of expanded autologous~     progeny of an adult CD34+ (haemopoietic) stem cell subset when infused directly into the~     tibial artery of patients with recent tibial fracture. The trial will also seek to determine~     clinical improvement or deterioration by measurement of clinical parameters such as, length~     of time to union of the fracture, changes in bone mineral density, improvements in pain~     scores (VAS), functional ability (TUGT) and IPAQ scores.~   "
223589|NCT00632021|"~     Many people who have recently left the hospital have difficulties managing their medications,~     and medication errors are common. Patients with low health literacy levels may have a~     particularly difficult time understanding medication dosing and instructions. This study will~     evaluate a literacy-focused program that provides educational assistance from pharmacists at~     the time of hospital discharge to people hospitalized with heart problems.~   "
223590|NCT00632008|"~     The purpose of this study is to determine whether the application of soluble beta-glucan~     (SBG) onto diabetic foot ulcers improves the healing of the ulcers.~   "
223591|NCT00631995|"~     This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus~     Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.~      Primary Objectives: Safety and Immunogenicity:~      To describe the safety and immunogenicity profiles of:~        -  A single dose of each formulation of TetraMen-T vaccine~        -  A single dose of NeisVac-C® vaccine.~   "
223592|NCT00631982|"~     In vitro maturation of oocytes after minimal gonadotropin stimulation in patients with~     polycystic ovaries, to prevent cases of ovarian hyperstimulation.~   "
223593|NCT00631969|"~     This study investigates the safety and efficacy of a new dosage form of Vardenafil, an~     orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo~     (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase,~     patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be~     determined by laboratory and other evaluations. Efficacy will be determined by the results of~     different questionnaires and the patient diary that will be used.~   "
223594|NCT00631956|"~     The purpose of this study is to determine the progression evaluation, cardiovascular~     outcomes, and genetic determinations of hypertension in Chinese~   "
223595|NCT00631943|"~     The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients~     with nerve pain~   "
223596|NCT00631917|"~     This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren~     (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.~   "
223633|NCT00631423|"~     The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in~     terms of etiology, clinical course and prognosis during long-term follow-up. Patients with~     isolated lower extremity DVT, matched for age and gender, serve as controls.~   "
223634|NCT00631410|"~     To assess the safety and tolerability of sunitinib when administered in combination with~     modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line~     treatment setting.~   "
223635|NCT00631397|"~     The study is to measure how dense or solid the infant's bones are using a new ultrasound~     machine and how that density changes over time.~   "
223636|NCT00631384|"~     The objective of this research is to evaluate the effectiveness of couples Voluntary~     Counseling and Testing for HIV (CVCT) compared to individual VCT (IVCT) in preventing MTCT,~     and in increasing preventive behaviors and minimizing spousal abuse among HIV positive women.~     We hypothesize that offering CVCT will not decrease uptake of VCT among women. This research~     will be carried out in 3 antenatal clinics in Dar es Salaam, Tanzania.~   "
223597|NCT00631904|"~     The purpose of this study is to monitor and follow non-pacemaker dependent patients with~     implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging~     (MRI) scans.~      Patients with pacemakers are currently excluded from obtaining MRI scans. MRI scanning is now~     the imaging of choice for a number of neurological, vascular, or musculoskeletal conditions.~      Data suggests that patients with pacemakers, when properly monitored, can safely undergo MRI~     scanning, though the largest published study to date consists of 54 patients, and no long~     term follow-up has been published.~      Though MRI cardiac scanning has been demonstrated to produce local tissue heating at the~     pacemaker lead tip, the long term effect of tissue heating on lead stability is unclear.~      This study will evaluate patients with permanent pacemakers undergoing medically indicated~     MRI scanning.~      Patients will be followed for one year at 3, 6, and 12 months. Data collected will evaluate~     change in pacing thresholds over time as well as cardiac troponin I, creatinine kinase MB~     function, and myoglobin levels within the first 12 hours following the scans, side effects,~     symptoms, the need to make pacemaker program changes, and possible artifacts created by the~     pacemaker on the MRI scan.~   "
223598|NCT00631878|"~     Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and~     Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the~     Prevention of S. epidermidis Infection. The purpose of this study is to evaluate the safety~     and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.~   "
223599|NCT00631865|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of melanocytes in patients with vitiligo.~   "
223600|NCT00631852|"~     This study was designed to explore the changes brought about by gelatin encapsulated extract~     of American Ginseng Root (LEAG) in breast cancer tumors and surrounding normal breast~     epithelial cells. Various tumor biomarkers, as well as inflammatory mediators, will be~     examined in tissue following LEAG treatment.~   "
223601|NCT00631839|"~     The purpose of this study is to evaluate clinical, dosimetrical, functional, biological and~     genetic factors in predicting chemo-radiotherapy induced lung and esophagus injury.~   "
223602|NCT00631826|"~     The evaluation of any relationship between the rotational resistance of the shoulder and~     shoulder flexibility with throwing arm injuries in professional and college level pitchers.~   "
223603|NCT00631813|"~     The purpose of this study is to determine which dose of prucalopride is safe and effective in~     patients with chronic constipation.~      Hypothesis:~      Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic constipation~     whereas 0,5 mg is a suboptimal dose.~   "
223604|NCT00631800|"~     The purpose of this study is to evaluate the safety (including tolerability),~     pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a~     3-dose regimen on Study Days 0, 7, and 14.~   "
223605|NCT00631787|"~     This study will try to determine what causes toxic side effects of stem cell transplantation,~     such as increased blood pressure, increased heart rate, decreased kidney function and~     abnormal heart rhythms. Stem cells are used to treat various diseases, including cancer,~     aplastic anemia and sickle cell disease. The cells may be given fresh to the patient or they~     may be preserved first with a chemical called DMSO and frozen for later use. Some stem cell~     transplant procedures include infusion of red blood cells along with the stem cells. This~     study will examine whether side effects of stem cell transplants are associated with the DMSO~     preservative in frozen cells or with hemoglobin (a protein released from defrosted red blood~     cells) or neither of these factors.~      Healthy volunteers and patients scheduled to receive a stem cell transplant may be eligible~     for this study. Candidates must be between 10 and 80 years of age.~      Transplant patients will undergo a stem cell transplant. The cells are infused through a~     catheter placed in a vein for the procedure. Depending on the patient s requirements, the~     infusion may or may not include red blood cells and may or may not contain DMSO. Healthy~     volunteers undergo a 4-hour saline infusion. The saline (water mixed with salt) is infused~     through a catheter (plastic tube) placed in a vein in the arm. In addition, all participants~     have the following tests and procedures:~        -  Heart monitoring: Healthy volunteers wear a portable heart monitor, attached to the~          chest using four stickers, for 24 hours starting the morning of the infusion. Transplant~          patients wear the same device for 48 hours, starting the morning before the infusion.~        -  Blood draws and urine collections before, during, just after and the morning after the~          infusion of saline or stem cells.~        -  Heart ultrasound before, during or just after and the morning after the infusion.~        -  Peripheral artery tonometry: A small cup is placed on one finger of each hand to measure~          blood flow in the finger. A blood pressure cuff is inflated around the lower arm and~          tight pressure is maintained for about 5 minutes.~   "
223606|NCT00631774|"~     This is a phase 4, 24-week, randomized, parallel, open-label study of a meal replacement~     program with Glucerna SR in obese Asian participants with type 2 diabetes. The duration of~     each subject's participation will be approximately 28 weeks, including a lead-in period of 2~     weeks and a 2-week post-treatment telephone follow-up. A sufficient number of Asian subjects~     with type 2 diabetes who have a BMI 18 between 25-40 kg/m2 and meet all the inclusion~     criteria and none of the exclusion criteria will be entered into the study to randomize~     approximately 60 subjects. Approximately 60 participants will be randomized to receive either~     (1) a meal replacement program with Glucerna SR on top of the Exchange-diet plan (EDP) or (2)~     an caloric-matched EDP only. The primary objective of this study is to evaluate the effect of~     a diet program including Glucerna SR as a meal replacement on postprandial glucose response~     after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes~   "
223607|NCT00631761|"~     Develop a tool to objectively quantify technical skills necessary to perform diagnostic~     cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS).~      Develop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or~     judged.~      Develop an intervention (1.5 hour workshop) which can be replicated by other residency~     programs in order to enhance learning of diagnostic cystoscopy. The workshop should be~     adequate for practicing Gynecologists as well as they already have experience with diagnostic~     hysteroscopy which uses many of the same concepts.~   "
223608|NCT00631748|"~     This placebo-controlled trial will test the effectiveness of Seroquel XR™ for the treatment~     of cocaine dependence in non-psychotic individuals who are cocaine dependent.~   "
223637|NCT00631371|"~     Primary objective: Comparison of independently assessed progression free survival (PFS) in~     subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab +~     Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response~     rate (independently assessed), and overall survival.~   "
223638|NCT00631358|"~     The primary purpose of this study is to quantify the change in expression of biomarkers on~     the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.~   "
223639|NCT00631345|"~     The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized~     trial designed to test the effectiveness of a lay-health counselor led community-based~     diabetes prevention program in reducing blood glucose in people at risk for developing~     diabetes mellitus.~   "
223609|NCT00631735|"~     This study is a qualitative, phenomenological research design. The research question is the~     lived experience of adult oncology patients undergoing chemotherapy being touched and~     touching. The researcher will conduct minimally-structured interviews with a set of follow-up~     interviews to verify interpretations and ascertain additional participant reflections on the~     phenomenon of touch. The purpose of this study is to describe the sensation of touch in adult~     oncology patients who are actively undergoing chemotherapy treatment. The primary objective~     is to identify the essences of multiple meanings of touch to these patients. The importance~     of touch in physiological development, learning patterns, and stress reduction has been~     demonstrated in humans and animals through years of research (Field, 2000). Based on research~     which indicates touch therapies provide a significant amount of symptom relief and reduction~     in anxiety, a growing number of hospitals and clinics are integrating massage therapy into~     services provided to patients in order to ameliorate many symptoms of diagnosis and/or~     treatment-related discomfort. Examples are the integrative medicine programs at Memorial~     Sloan-Kettering Cancer Center and George Washington University Medical Center which include~     touch therapy modalities. Research focusing on the embodied experience of sensory phenomena~     such as touch is important to provide the basis for more effective care. No studies to date~     have focused on the self-reported experience of the cancer patient with regard to what touch~     means to these individuals, particularly those actively in treatment with intravenous~     chemotherapy. The embodied sensation of touch in these people is important to understand in~     order to provide more effective touch-based interventions and also to increase awareness of~     direct care staff, including nurses, of the profound and complex effect that all forms of~     touch have on those who are physically and psychically vulnerable.~   "
223610|NCT00631722|"~     This study attempts to observe the efficacy (response time) and safety of the~     second-generation antipsychotic agent-quetiapine versus the first-generation antipsychotic~     agent-haloperidol, in treating acute schizophrenia episode and to evaluate the effect of the~     effectiveness of acute schizophrenia episode on long-term tolerability.~   "
223611|NCT00631709|"~     The purpose of this study is to evaluate the potential clinical and economic benefits of~     using CareLink remote management for pacemaker follow-up.~      Study Objectives include:~        1. To determine clinician perceived quality of care for CareLink remote follow-up.~        2. To determine patient satisfaction with CareLink follow-up.~        3. To estimate the time required to perform patient follow-up via CareLink remote~          transmissions.~        4. To determine the percentage of regular CareLink follow-ups that do not require further~          in-clinic review of the patient.~        5. To estimate potential patient cost avoidance for one year of follow up incorporating~          CareLink.~        6. To evaluate compliance to scheduled CareLink transmissions with the remote management~          system~      This is a non-randomized, multi-center, prospective study in which 120 patients who have a~     pacemaker are enrolled into the study and receive a CareLink monitor. Patients will replace~     their regularly scheduled pacemaker clinic follow-up visits with a CareLink remote~     transmission for 12months.~      Patients will require a test transmission within 1 month after they receive their CareLink~     monitor. Afterwards, patients are followed via CareLink transmissions as per their usual~     clinic schedule for 12 months.~   "
223612|NCT00631696|"~     This study is being performed as a Phase IV FDA commitment study and is being powered~     adequately to assess changes in sperm concentration, FSH and testosterone in healthy male~     subjects treated with pregabalin as compared to placebo, in addition to confirming lack of~     effects on sperm motility.~   "
223613|NCT00631683|"~     Failure to wean from mechanical ventilation (failure to get the patients off the breathing~     machine) is associated with prolonged stay in the intensive care unit and increased risk of~     death. Some patients have difficulty successfully getting off the ventilator and breathing on~     their own. Usually this difficulty is due to lung problems. But sometimes it is due to heart~     problems, or heart failure. To improve a patient's chances of successfully getting off the~     ventilator early, it is helpful to the doctors to know if patient has heart failure and to~     measure how severe. With the new monitoring system being studied here, doctors may be able to~     detect and measure heart failure more easily.~      A new monitor (Vigileo TM) that is connected with a specific cable (Flo-TracTM) to a catheter~     that is inside the patient's artery (arterial line) has lately been developed. This monitor~     can estimate the amount of blood that the heart is pumping per minute, known as cardiac~     output. The heart is supposed to pump blood harder when a patient is being weaned from the~     breathing machine. With the above mentioned monitor, we hope to detect those patients whose~     hearts are weak and are not pumping as hard as they should.~   "
223614|NCT00631670|"~     The purpose of this research study is to determine if Stereotactic Body Radiation Therapy~     (SBRT) is a good way to treat tumors near the spinal cord. Patients will either receive a~     single treatment or 25 days of treatment given once-a-day, Monday through Friday for about 5~     continuous weeks. Our protocol uses life expectancy, patient preference, and tumor size to~     determine whether SBRT is delivered with 1 or 25 treatments. The single treatment dose is 15~     Gy. The 25 treatment group is 70 Gy at 2.8 Gy/treatment.~   "
223615|NCT00631657|"~     To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081,~     SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia.~     Primary efficacy variable is Total Sleep Time (TST).~   "
223616|NCT00631644|"~     This study will explore the eating habits of adolescents and determine if eating behavior is~     linked to genetics.~      Healthy adolescents between 13 and 17 years of age may be eligible for this study. Candidates~     come to the NIH Clinical Center at 8:00 AM to be screened with the following:~        -  Medical history and brief physical examination, including height, weight, and body fat~          measurements. Body fat is measured using a device called a Bod Pod. The adolescent sits~          inside the device for about 5 minutes and the machine determines body fat by measuring~          air movement. The adolescent must wear a tight-fitting swimsuit for this test.~        -  Urine test to look for sugar or protein in the urine and to test for pregnancy in~          females.~        -  Blood tests for routine chemistries and for gene studies related to eating behaviors.~        -  Questionnaires and interviews about the adolescent s general health and eating habits.~        -  Acclimatization to test meal conditions for the study. The adolescent is given a~          breakfast shake to drink.~      Participants come to the NIH Clinical Center at 10:30 AM for laboratory meal testing. At this~     visit, the adolescent does the following:~        -  Eats food from a buffet of everyday foods that most kids eat.~        -  Fills out questionnaires.~        -  Tastes and rates the flavor of a variety of snack foods.~   "
223617|NCT00631631|"~     The purpose of this study was to collect information regarding the safety and tolerability of~     mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).~   "
223640|NCT00631332|"~     The Women's Health Initiative Study of Cognitive Aging (WHISCA) is a two-armed, randomized,~     placebo controlled, clinical trial designed to assess the efficacy of postmenopausal hormone~     therapy (HT) on age related changes in specific cognitive functions.~   "
223618|NCT00631618|"~     The purpose of this study is to investigate whether an investigational drug called sunitinib~     malate is safe and effective in treating metastatic melanoma in patients with KIT mutations.~      KIT is a gene that codes for (contains the genetic code that the body uses to make) a~     protein on the surface of cells in your body that is important in cell growth and cell~     division. The KIT protein seems to play a role in abnormal cell growth seen in acute~     leukemia, germ cell tumors, gastrointestinal stromal tumors (GIST), and certain melanomas.~     Melanomas that arise on acral skin (palms, soles, nail beds), mucosal membranes, and~     chronically sun damaged skin have recently been found to frequently contain mutations or~     increased copy numbers of the KIT gene. Your tumor tissue has previously been tested and has~     been found to contain abnormalities in the KIT gene.~      Sunitinib malate is drug that has been shown to inhibit the activity of the KIT protein. The~     FDA approved sunitinib in 2006 for patients with GIST. It has been shown that sunitinib~     malate works in these patients because of its activity against the KIT protein. The FDA also~     approved Sunitinib malate in 2006 for the treatment of metastatic kidney cancer, where its~     effectiveness is probably due to its ability to block a different set of proteins.~      Sunitinib malate has not been approved by the FDA for the treatment of metastatic melanoma.~   "
223619|NCT00631605|"~     This study aims to investigate neuroendocrine, autonomic functioning, and energy metabolism~     in patients with eating disorder and their relationships with psychopathology of eating~     disorders (eating patterns, depression, and personality) in these patients.~   "
223620|NCT00631592|"~     This is a repeat dose escalation study of GSK1349572 followed by a relative bioavailability~     study comparing tablet and suspension formulations in healthy volunteers.~   "
223621|NCT00631579|"~     The primary objectives of the study are to evaluate the safety and the efficacy in patients~     with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days~     in two dosage groups.~      Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to~     assess anti-SR29142 antibody production in patients with malignant lymphoma and acute~     leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the~     results of efficacy and safety evaluations.~   "
223622|NCT00631566|"~     This study will prospectively evaluate the prevalence and incidence (over a two year period)~     of MRSA colonization and infection among HIV-infected military beneficiaries to determine~     predictors for the development of MRSA colonization and infection. This study will also~     investigate the utility of decolonization procedures for clearance of MRSA carriage and~     prevention of MRSA infections. Finally, the molecular characteristics and the antimicrobial~     sensitivities of isolates in this population will be determined.~   "
223623|NCT00631553|"~     The purpose of this study is to determine if contrast enhanced ultrasound (CEU) using~     microbubbles, is useful in assessing changes in kidney blood flow.~   "
223624|NCT00631540|"~     The purpose of the study is to evaluate the safety and effectiveness of the Formula~     Balloon-Expandable Stent in treatment of renal artery stenosis.~   "
223625|NCT00631527|"~     The goal of this clinical research study is to learn the safety of adding 3 different~     dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation~     in patients with prostate cancer.~   "
223626|NCT00631514|"~     NSAIDs may increase blood pressure and blunt the effects of many antihypertensives. Members~     of these drug classes differ in their propensity to such an interaction.~   "
223627|NCT00631501|"~     Matrix metalloproteinases are involved in the pathogenesis of tendinopathy. Doxycycline, a~     widely available pharmaceutical agent mostly used for its antibiotic properties, also~     functions as an inhibitor of MMPs.~      This study aims to investigate the effect of doxycycline treatment on lateral epicondylalgia~     (tennis elbow). During three weeks, patients receive doxycycline tablets 100 mg twice daily,~     or placebo. Main outcome variable is pain (VAS) at three weeks.~      Serum and/or plasma levels of matrix metalloproteinases and tissue inhibitors of~     metalloproteinases are measured.~   "
223628|NCT00631488|"~     This study will test the effectiveness and safety of treatment with MK-0893 in combination~     with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.~   "
223629|NCT00631475|"~     This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed~     protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability~     of bosentan in patients with idiopathic pulmonary fibrosis (IPF).~   "
223630|NCT00631462|"~     The purpose of this study is to evaluate the safety and tolerability of orally administered~     TG101348 in patients with myelofibrosis.~   "
223631|NCT00631449|"~     The purpose of this study is to determine whether treatment with Raltegravir further~     decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially~     improving immune response to antiretroviral therapy.~   "
223632|NCT00631436|"~     Brain injury from explosive blast is a prominent feature of contemporary combat. Although~     protective armor and effective acute medical intervention allows soldiers to survive blast~     events, a growing number of veterans will have disability stemming from blast-related neural~     damage. Soldiers also return from combat with psychological disabilities caused by traumatic~     war events. The clinical presentation of individuals with blast-related neural damage and~     post-traumatic psychopathology are markedly similar and thus a clear description of the~     direct consequences of explosive blast is complicated by the emotional and cognitive sequelae~     of psychological trauma. We will use sophisticated measures of neural function and structure~     to characterize brain injury from explosive blasts in a sample of Operation Iraqi Freedom~     (OIF) National Guard soldiers who returned from deployment in the fall of 2007. Survey data~     gathered near the end of deployment indicated that over 50% of the brigade had been exposed~     to direct physical effects of explosive blasts. To fully characterize the effects of blast on~     the brain and differentiate them from post-traumatic stress disorder, we will contrast groups~     of soldiers exposed to blast and with groups experiencing post-traumatic stress disorder.~     This investigation will improve the characterization of blast-related traumatic brain injury,~     describe the essential features of the condition in terms of neural function and structure to~     inform diagnosis, and characterize mechanisms of recovery after blast-related neural injury~     to allow the creation of interventions that return soldiers to maximum levels of functioning.~   "
223641|NCT00631319|"~     To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in~     patients with Osteoarthritis (OA) Pain~   "
223645|NCT00631267|"~     Rationale:~      Many different closed techniques are used to reduce a dorsally dislocated distal radius~     fracture (Colles' fracture). One trial to compare two main techniques (finger-trap traction~     and manual manipulation) did not find significant difference in radiological and clinical~     outcome (Earnshaw 2002). This trial aims to investigate patient and medical satisfaction~     between both techniques~      Objective:~      To demonstrate patient satisfaction (pain, duration, general) and medical satisfaction~     (difficulty of reposition). It is suggested that finger-trap traction causes less pain for~     patients and is more easy than manual manipulation but have the same radiological and~     clinical outcome.~      Study design:~      Randomised controlled intervention study~      Study population:~      300 Patients with newly diagnosed closed distal radius fractures with dorsal angulation~     (Colles' fracture) older than 16years coming to the Emergency Medical Department.~      Intervention:~      One group is put in finger-trap traction (digitus 1-3) for 10minutes with 4-5kg of ballast on~     their upper arm followed by reduction by dorsal pressure. The other group is manually reduced~     according to Charnley with traction and hooking over of the fracture elements.~      Main study parameters/endpoints:~      Visual analogue scale of patient and medical satisfaction, percentage of successful primary~     reductions. Nature and extent of the burden and risks associated with participation, benefit~     and group relatedness: Apart for the regular follow-up of patients with distal radius~     fractures,one extra out-patient visit is necessary to assess functional outcome after three~     months.Finger-trap traction has a (theoretical) risk of causing traumatic damage to ligaments~     of the fingers, but this risk is in our opinion not higher than in the manual manipulation.~     It is expected that the finger-trap traction group is more satisfied because this technique~     seems less traumatic than but as successful as the manual manipulation group.~   "
223646|NCT00631254|"~     Cysteinyl leukotrienes (CysLTs) play an important role in asthma. CysLTs exert most of their~     bronchoconstrictive and pro-inflammatory effects through activation of the CysLT1-r. As~     allergic rhinitis appears to be a predisposing factor in the development of asthma and as~     CysLT-receptors seem to be implicated in the first steps of asthma manifestations, we think~     it would be of interest to determine if the CysLT1-r is a key mediator in the progression~     from allergic rhinitis to asthma. We believe it would be interesting to study the expression~     of the CysLT1-r~      Our goal is to assess baseline, as well as variations following allergen bronchoprovocations,~     in the expression of the CysLT1-r in mild asthmatic subjects compared with non asthmatic~     subjects with allergic rhinitis.~      Our hypothesis is that there will be a higher baseline expression of the CysLT1-r in~     asthmatic subjects compared with allergic rhinitis subjects and that allergen~     bronchoprovocations will induce an increase in the expression of the CysLT1-r in both groups.~   "
223647|NCT00631241|"~     The goal of this clinical research study is to find out if the parametrial nodes are~     sentinel nodes (the lymph nodes believed to be the greatest risk for the spread of cancer)~     and if intraoperative lymphatic mapping can identify sentinel lymph nodes in the~     parametrium (the tissue that is on either side of the cervix). Identifying these lymph nodes~     may help to predict the status of the remaining lymph nodes in the pelvis. This research will~     also determine if India Ink is safe to use with the blue dye and radioactive tracer and if it~     improves the process of identifying the sentinel nodes.~   "
223648|NCT00631228|"~     XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study~     to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real~     world settings.~   "
223649|NCT00631215|"~     HYPOTHESIS~        1. Hyperbaric Oxygenation Therapy will be safe to use with neurotypical adults and~          children.~        2. Hyperbaric Oxygenation Therapy will have a statistically significant positive effect on~          measures of cognitive function in neurotypical adults and children.~        3. The improvement in cognitive function will correlate positively with the number of~          Hyperbaric Oxygenation Therapy sessions.~        4. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at~          follow-up, post 40 treatment sessions.~   "
223650|NCT00631202|"~     Friedreich's ataxia is a rare genetic disorder characterized by severe neurological~     disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency.~     Although several drugs have been proposed, there is no available treatment. It was recently~     demonstrated that erythropoietin can increase the intracellular levels of frataxin in an~     in-vitro model.~      The present project is aimed at testing the possible therapeutic approach of erythropoietin,~     which is an already available and commercialized drug. The investigators will perform both~     in-vitro and in-vivo tests, in order to asses its efficacy and safety in patients. The~     results will be useful to plan further clinical trials.~   "
223651|NCT00631189|"~     The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an~     hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and~     Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation~     after 8 weeks of treatment.~   "
223652|NCT00631176|"~     This is a prospective interventional study to test the hypothesis that just-in-time training~     for pediatric airway management may improve patient safety and operational performance of~     orotracheal intubation and decreases intubation associated events in pediatric residents in~     the PICU. To test the hypothesis that high fidelity simulation may enhance the training~     efficacy and patient safety in simulation settings.~   "
223653|NCT00631163|"~     The overall purpose of this trial is to further evaluate the efficacy and safety of~     deferasirox, dosed initially according to the transfusional iron intake, in patients with~     transfusion dependant anemia related to disorders other than β-thalassemia and sickle cell~     disease.~      During the study, the dose will be adjusted based on serum Ferritin.The overall purpose of~     the extension is to allow further treatment of patients who have already completed the core~     study, and to enable collection of long term efficacy and safety data. Patients will continue~     to receive Deferasirox at the dose they received at the end of the core study.~   "
223654|NCT00631150|"~     Patients in community-based practices correspond to the 25% of patients who need a first~     add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic~     use trial in which the population corresponds more closely to that seen in daily clinical~     practice.~   "
223655|NCT00631137|"~     RATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness~     caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade~     glioma.~      PURPOSE: This randomized clinical trial is studying how well testosterone gel works in~     preventing weakness caused by steroid therapy in men receiving glucocorticoids for newly~     diagnosed high-grade glioma.~   "
223656|NCT00631124|"~     Investigation of a new pill containing an estrogen and a progestin in order to monitor the~     inhibition of the ovulation in young healthy females over 3 treatment cycles~   "
223657|NCT00631111|"~     Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in~     the treatment of pain following third molar extraction in comparison to single doses of~     placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.~   "
223658|NCT00631098|"~     International CPR guidelines recommend the cannulation of a peripheral vein (antecubital or~     external jugular) during resuscitation. One reason for preferring the external jugular vein~     over more peripheral veins is the faster circulation time of drugs during CPR. The~     differences in circulation time may be over 90 seconds between peripheral and central~     (internal jugular) veins. However, cannulation of the external jugular vein may be more~     difficult and time consuming than cannulating cubital veins. There are no studies on the~     success rate, cannulation time and reliability of venous access comparing central and~     peripheral cannulation sites.~      We hypothesized that cannulation of the external jugular vein (by paramedics and is a~     demanding procedure in an emergency situation and should not be recommended during~     resuscitation.~      The aims of this study are to compare the feasibility of cannulating the external jugular~     vein compared to the cubital vein in terms of attempts, cannulation time and reliability of~     venous access.~   "
223659|NCT00631085|"~     The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol)~     will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is~     found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a~     component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT),~     another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet,~     but is the major form in blood and tissue. It is also the major form of Vitamin E in~     over-the-counter supplements. However, gT has anti-inflammatory properties which are not~     present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in~     animal studies, and previous studies have shown levels of gT are inversely associated with~     heart disease.~      We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air~     pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin~     units) we will see an increase in the number of neutrophils (a type of white blood cell that~     your body produces to fight infection) in your lung cells without causing you to have~     flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells~     after the endotoxin challenge when you take the gT versus when you take a placebo.~   "
223660|NCT00631072|"~     The purpose of this research study is to determine whether we can purify and grow a~     population of cells from the participants blood (iNKT cells) and then safely give them back~     to the participant in increased numbers, and whether these cells will then stimulate the~     bodies own immune response against the cancer. These iNKT cells have been used in laboratory~     studies and information from these and other research studies suggest that increasing the~     number of these cells in the blood can stimulate the immune response against tumors.~   "
223661|NCT00631059|"~     The objective of this protocol is to collect leukemia cell specimens from adults (18 years of~     age) diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time~     of first relapse. These specimens, in conjunction with a de-identified data set, will be~     utilized prospectively to determine potential chemotherapy resistance in this patient~     population.~      The specific aims of this study are as follows:~      To collect peripheral blood specimens from patients diagnosed with acute leukemia at time of~     initial diagnosis and, if applicable, at time of first relapse To evaluate the leukemia cells~     in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology~      To develop a body of evidence from acute leukemia patients that demonstrates the~     applicability of the Hem(A)+ assay to determine the following:~      Predict responders and non-responders to common chemotherapeutic agents Track treatment~     results and comparison to prediction results from the assay Identify optimal chemotherapy~     doses for each patient Identify the most efficacious pharmaceutical agent combinations~   "
223662|NCT00631046|"~     The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and~     body composition, intestinal health and microbiotic composition, immune function and risk~     markers for later diseases in 9-18 months old infants and toddlers.~   "
223663|NCT00631033|"~     The purpose of this study is to determine whether there is an additive effect of metformine~     on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.~   "
223664|NCT00631020|"~     Reducing tobacco use by adolescents is a national health priority. In recent polls, most~     adolescent smokers reported having tried unsuccessfully to quit. Smoking cessation treatment~     during adolescence has the potential to interrupt the progression to nicotine dependence,~     which is attended by a wide range of negative health consequences. Given the need for~     effective smoking cessation programs aimed at youth, scientifically rigorous research is~     warranted to reduce adolescent smoking. This project will address gaps in the scientific~     treatment literature. The goal of this project is to develop a tailored, practical, and~     efficacious smoking cessation intervention. Combined with other efforts in the field, this~     work can provide an initial guide to an evidence-based treatment for smoking cessation in~     youth.~      In keeping with developments in other fields of medicine, we believe that further advances in~     smoking cessation will move towards a goal of personalized treatment. Such an individualized~     approach for adolescent smoking cessation will be informed by further investigation of the~     relationships between outcomes in this trial. To serve these goals, we propose the following~     program:~      Youths who smoke regularly will receive a 6 week intervention using cognitive-behavioral~     motivational enhancement (CBME) supplemented by nicotine replacement therapy (NRT), if youth~     and parents desire this option. Furthermore, youth has to smoke more than 5 cigarettes a day~     in order to qualify for nicotine replacement therapy. This approach is consistent with~     treatment guidelines for smoking cessation (Fiore 2000).~      Compared with participants who fail to achieve smoking cessation, those who successfully~     achieve smoking abstinence during intervention, will have lower baseline rates of comorbid~     ADHD, lower depressive symptom scores, enhanced readiness to quit, more negative attitudes~     towards smoking, fewer friends who smoke, and fewer family members who smoke. The~     investigators predict that the intervention will help youth to quit smoking and will examine~     predictions of successful quitting.~   "
223665|NCT00631007|"~     This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with~     pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women~     (of non-childbearing potential or using dual barrier methods of contraception) between 30 and~     75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or~     sulfonylurea plus metformin combination therapy.~   "
223666|NCT00630994|"~     RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying the side effects and how well low-dose decitabine~     works in treating patients with symptomatic myelofibrosis.~   "
223667|NCT00630981|"~     The purpose of this observational study is to measure the efficacy of a specific combined~     treatment (psychotherapy and pharmacotherapy) on patients with dissociative disorders, in~     terms of patients with a favorable outcome by means of the Dissociative Experiences Scale~     (DES).~   "
242423|NCT00381316|"~     The study is designed to determine whether a dual isotope protocol is equivalent to a single~     isotope in the diagnosis of myocardial ischemia and infarction using MYOVIEW SPECT imaging.~   "
223669|NCT00630955|"~     The purpose of this study is to evaluate the effects of the study medication, memantine~     (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which~     participants are given an initial drink of alcohol followed by the choice to drink up to 12~     more drinks over a three-hour period. We hypothesize that memantine will reduce craving and~     number of drinks consumed prior to and after exposure to the initial drink of alcohol and~     during the three hour drinking period. We will also evaluate the influence of family history~     of alcoholism on the efficacy of memantine in reducing alcohol drinking behavior.~   "
223670|NCT00630942|"~     The purpose of the study is to see how safe and effective minocycline is in the treatment of~     Primary Sclerosing Cholangitis (PSC).~   "
223671|NCT00630929|"~     To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with~     osteoarthritis (OA) of the knee.~   "
223672|NCT00630916|"~     This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart~     Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve~     prosthesis.~   "
223673|NCT00630903|"~     The purpose of this study is to determine if combination of PUVA with interferon alpha is~     better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.~   "
223674|NCT00630890|"~     The purpose of this study is to test the safety of giving external beam radiation, followed~     by a Cyberknife radiosurgery boost at different dose levels, together with a chemotherapy~     drug called capecitabine. The dose of Cyberknife radiosurgery boost will be made higher~     slowly in this protocol. Patients with hilar cholangiocarcinoma (Klatskin tumor), which is~     not amenable for surgical removal, are eligible.~      The hypothesis is that highly focused high dose radiation delivered using Cyberknife in~     conjunction with traditional radiation and chemotherapy can improve outcome in this patient~     population.~   "
223675|NCT00630877|"~     The primary purpose of this study was to evaluate the psychometric characteristics~     (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects~     receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks.~      The FAST is a questionnaire that was developed to provide a detailed assessment of flushing~     symptoms and their impact in patients receiving niacin therapy. The effect of aspirin on~     flushing symptoms, as measured by the FAST, was also evaluated.~   "
223676|NCT00630864|"~     This is an open-label, multicenter, international study designed to determine TTR~     stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical~     outcomes in patients with non-V30M TTR amyloidosis.~      Strong pre-clinical and clinical evidence support a daily dose of 20 mg of Fx-1006A to be the~     optimum dose to achieve stabilization of tetrameric TTR in ATTR-PN patients. Since disease~     presentation is similar between V30M and non-V30M TTR mutations associated with ATTR-PN and~     Fx-1006A has been shown to stabilize wild-type and V30M TTR in vitro and ex vivo, the present~     study is being conducted to determine the effects of Fx-1006A on TTR stabilization in ATTR-PN~     patients with TTR mutations other than V30M. Safety and exploratory efficacy of Fx-1006A~     administered once daily for 12 months will also be evaluated in this patient population.~      This is an open-label, multicenter, international study designed to determine TTR~     stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical~     outcomes in patients with non-V30M TTR amyloidosis. The study will be conducted in two parts.~     Part 1 will include a six-week dosing period during which all enrolled patients will receive~     oral Fx-1006A 20 mg soft gelatin capsules once daily for six weeks. At Week 6, blood samples~     will be collected from each patient to determine TTR stabilization. Patients who complete the~     Week 6 visit will continue receiving daily oral Fx-1006A 20 mg for up to a total of 12 months~     during Part 2 of this study. If it is determined that a patient is not stabilized at Week 6,~     the patient will be discontinued from the study.~      During Part 2, clinical outcomes will be measured at Months 6 and 12, based on NIS, Norfolk~     QOL-DN, mBMI, NCS, HRDB, SF-36, Karnofsky score, and echocardiography; NT-pro-BNP and~     troponin I levels will be measured at Baseline, Weeks 2 and 6, and Months 3, 6, and 12.~      Pharmacokinetic measurements will be made using samples collected at Baseline, Week 6, and~     Months 6 and 12.~      Safety and tolerability will be assessed throughout the study based on vital signs, physical~     examinations, ECG, echocardiography, 24-hour Holter monitoring, clinical laboratory tests~     (hematology, serum chemistry, and urinalysis), and monitoring adverse events and concomitant~     medication use.~      Day 1 will be defined as administration of the first dose of study drug. Clinic Visits will~     be conducted during Screening (Days -30 to -1) and at Baseline (Day 0), and Week 2, and Week~     6, and Months 3, 6, and 12 (± 2 weeks of the scheduled date for post-Baseline visits).~     Monthly telephone contacts (+ 1 week of the scheduled date) will be made during months in~     which no investigative site visits are scheduled (Months 4, 5, 7, 8, 9, 10, and 11) for~     assessment of adverse events and concomitant medications. A final telephone contact to assess~     adverse events and concomitant medication usage will be made 30 days after the last dose of~     study drug.~      Patients who discontinue from the study at any time following enrollment will have a final~     visit performed, including all safety assessments, at the time of discontinuation. Any~     patient discontinuing after the Month 6 visit will also have all exploratory assessments~     performed.~   "
223677|NCT00630851|"~     The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home~     patients with severe Alzheimer's disease.~   "
223678|NCT00630838|"~     Prospective, randomized, controlled trial to test if post-operative administration of~     probiotics in HD patients will lead to a reduction in the occurrence of HAEC.~   "
223679|NCT00630825|"~     To study once weekly injections of LY2189265 compared to placebo on blood glucose by~     measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight~     Type 2 Diabetes Mellitus participants.~   "
223680|NCT00630812|"~     The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with~     inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated~     improvements in lung function, mucociliary clearance, changes in physical properties of~     mucus, 24 hour sputum weight and quality of life. The results of this study are to further~     investigate and confirm these findings in addition to examine the effect on antibiotic use~     and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects~     compared to a control treatment. An open label phase of 26 weeks duration will follow the~     blinded 26 week phase. During the open label phase all subjects will receive active~     treatment.~   "
223681|NCT00630799|"~     This is a multi-center, open-label study of 2 doses of leuprolide acetate 17 mg depot,~     administered three months apart, in subjects with prostate cancer who might benefit from~     medical androgen deprivation therapy~   "
223682|NCT00630786|"~     This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2)~     study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal~     Cancer.~   "
223683|NCT00630773|"~     This prospective, pilot observational study will be performed in the Emergency Department~     (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and regular inpatient care~     area (RIPCA) settings at the Children's Hospital of Philadelphia. The differences in trained~     pediatric health care provider placement of the compression sensor and their assessment of~     the suitability / willingness to use the current or size modified sensor will be assessed.~   "
223684|NCT00630760|"~     This phase I study will determine the safety profile of NRX 194204 on this schedule; it will~     evaluate the pharmacokinetic profile of NRX 194204 in cancer patients; and will investigate~     anti-tumor activity as manifested by standard response criteria, or by tumor markers.~   "
225323|NCT00608855|"~     RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.~      PURPOSE: This clinical trial is studying the side effects and how well percutaneous~     cryoablation works in treating patients with painful bone metastases.~   "
223685|NCT00630747|"~     Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year~     Phase 2/Phase 3 registration study. The primary objective of this extension study was to~     collect long-term safety and clinical outcome data in Mucopolysaccharidosis II (MPS II), also~     known as Hunter Syndrome, from the Phase 2/Phase 3 Study TKT024. All patients enrolling into~     this study received weekly active treatment with idursulfase, the primary dosing regimen~     investigated in Study TKT024.~      Hunter Syndrome is an X-linked recessive lysosomal storage disease caused by a deficiency of~     iduronate-2-sulfatase, an enzyme required to catabolize glycosaminoglycans (GAGS) in cells.~     As a result, GAGs accumulate in the lysosomes leading to cellular engorgement, organomegaly,~     tissue destruction, and organ system dysfunction. Hunter Syndrome is a rare disease with an~     estimated incidence of 1 in 162,000 live births.~   "
223686|NCT00630734|"~     Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to~     treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food~     and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given~     with pravastatin, they can increase the blood levels of pravastatin. The degree of this~     interaction varies from person to person. The way that darunavir and ritonavir interact with~     pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those~     that people are born with and that make each person unique. Genetic differences are the~     reason why one person's body traits such as height and hair color are different from another~     person's body traits. Genetic differences can also affect the way a medication works in the~     body or the way two medications interact in the body. The purpose of this clinical study is~     to determine if a person's genetic make-up affects the way darunavir and ritonavir interact~     with pravastatin in the body.~   "
223687|NCT00630721|"~     Determine the in-vivo mechanism of action of INF-B-1b as it's mechanisms of action are not~     completely understood. We propose that high dose exogenous recombinant IFN-B-1b induces~     tolerizing effect on DC-dependent T-cell differentiation in patients with MS by inducing the~     expression of SOCS3 in DCs.~   "
223688|NCT00630708|"~     The primary aim of the present study is to assess the safety of combined treatment of~     benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced~     renal insufficiency.~   "
223689|NCT00630695|"~     Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo.~     Evaluation of the lymphorrhea in the 2 arms of the study~   "
223690|NCT00630682|"~     The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help~     methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible~     participants will attend research visits twice per week, and will receive individual~     counseling sessions once per week for all 9 weeks. 50% of the participants will receive the~     active medication while the other 50% will receive the placebo (sugar pill). Neither the~     participant or the study team will know if the participant is receiving the placebo or active~     drug.~   "
223691|NCT00630669|"~     The purpose of this study is to determine which treatment, band ligation (placing rubber~     bands around the hemorrhoids) or BICAP electrocoagulation (using electricity to cauterize) is~     safer and more effective endoscopic treatment for bleeding internal hemorrhoids.~   "
223692|NCT00630656|"~     Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an~     addition to the standard care of severe sepsis.~   "
223693|NCT00630643|"~     The purpose of the study is to assess the safety and tolerability of daily intravenous~     NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to~     modulate the CD3 complex on T-cells.~   "
223694|NCT00630630|"~     The relationship between hormone cycling/fluctuations and the occurrence of seizures in women~     has received considerable discussion in the medical literature. This study investigated the~     efficacy and tolerability of LEV treatment for subjects with catamenial exacerbation of~     partial onset seizures.~   "
223695|NCT00630617|"~     To develop and evaluate a culturally appropriate childhood obesity prevention program~     targeting primary care-givers of third grade students. The cognitive-behavioral lifestyle~     intervention consisted of eight, 90-minute sessions at the elementary schools.~      Primary outcome: body mass index of third graders and their primary care-givers Primary~     objective: To engage primary care-givers of third grand children in identifying and creating~     health promoting culturally appropriate environments for young children.~   "
223696|NCT00630604|"~     The purpose of this study is to investigate the feasibility of using quantitative~     ultrasonography (US) evaluation to determine the severity of osteoarthritic femoral condyle~     cartilage erosion.~   "
223697|NCT00630591|"~     Primary Aim:~      -To explore the feasibility and acceptability of two distinctly different tailored,~     home-based diet and exercise interventions (one that relies on a partner-assisted, team-based~     approach that emphasizes the mother-daughter bond and one that is delivered to each~     independently) vs. standardized materials (attention control). This aim will be accomplished~     by assessing overall accrual, and by quantifying retention and adverse events in each study~     arm.~      The study will be deemed feasible if it achieves the following criteria:~        1. Accrual of 67 mother-daughter dyads into the intervention is accomplished within a~          1-year period;~        2. An attrition rate of less than 20% is achieved; and~        3. The frequency of total adverse events is not significantly higher in either of the~          intervention arms (as compared to the attention control arm), and there is no more than~          one reported serious adverse event that is directly attributable to either of the~          interventions.~      Detailed process data also will be collected on each intervention, i.e., use and perceived~     helpfulness of materials in promoting behavior change, frequency and quality of interaction~     between members of the mother-daughter dyad, feedback regarding intervention materials, etc.~      Secondary Aim:~      -To explore potential effects (and variation) noted among each of the three intervention arms~     from baseline to 6 and 12- month follow-up on the following endpoints: BMI, energy intake and~     nutrient density of the diet, exercise [min/week and metabolic equivalents (METs)],~     self-efficacy to adhere to an energy restricted, plant-based, low saturated fat diet and~     increased exercise, blood pressure, health-related quality of life (HRQOL), social support~     (in general and as specifically related to healthful dietary and exercise behavior), and~     characteristics of the mother-daughter bond (e.g., strength).~      Secondary Aim:~      -To explore potential mediators and moderators of healthful dietary and exercise behaviors,~     such as the strength of the mother-daughter bond, geographic proximity of mothers and~     daughters, self-efficacy for lifestyle change, etc.~   "
223708|NCT00630435|"~     The purpose of this trial is to determine the equivalence of 3 new formulations of a~     Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed~     dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women.~     Each subject will participate in the study for approximately 14 weeks, including a screening~     evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with~     at least a 21-day washout interval between each dose administration.~   "
223698|NCT00630578|"~     This proposal seeks to increase the effectiveness of an existing treatment strategy,~     cognitive processing therapy (CPT), for the remediation of Posttraumatic Stress Disorder~     among crime victims by varying the duration and content of the intervention in accordance~     with participants' needs. A secondary goal is to identify predictors of duration of treatment~     necessary to achieve good end state functioning, including individual and trauma variables,~     cognitive and emotional variables, and Axis II pathology. Finally, by including a sample of~     male participants, the generalizability of CPT will be tested. It is anticipated that these~     modifications will speed the dissemination of CPT to community practice thus benefiting more~     trauma victims. Fifty subjects will be randomly assigned to either the modified CPT condition~     or to a symptom-monitoring, minimal attention condition designed to control for the effects~     of the daily monitoring and the passage of time. Utilizing a semicrossover design, the~     control condition will be crossed over to the active treatment, allowing for a replication~     within the study. The entire treated sample (N = 50) will be compared to a sample (N = 50)~     receiving strict 12-session protocol-driven CPT through the course of a recent study~     conducted at the same site using the same primary outcome measures. Conducting the proposed~     study will have important implications on advancing the ecological validity and effectiveness~     of applied research on PTSD.~   "
223699|NCT00630565|"~     RATIONALE: Giving chemotherapy and colony-stimulating factors, such as G-CSF, may increase~     the number of stem cells in the blood. The stem cells are collected from the patient's blood~     and stored. Chemotherapy or radiation therapy is given to prepare the bone marrow for the~     stem cell transplant. The stem cells are then returned to the patient to replace the~     blood-forming cells that were destroyed by the chemotherapy and radiation therapy.~      PURPOSE: This clinical trial is studying how well an autologous stem cell transplant works in~     treating patients with acute myeloid leukemia.~   "
223700|NCT00630552|"~     This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine~     as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an~     open-label, dose-escalation phase 1b segment to determine the safety, tolerability and~     maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of~     the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to~     estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo~     in combination with gemcitabine. The phase 2 segment that will commence after dose selection~     in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in~     combination with gemcitabine.~   "
223701|NCT00630539|"~     The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5~     mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum~     effective dose below the lowest dose of 30 mg tested earlier in Phase II.~   "
223702|NCT00630513|"~     The aim of the study was to compare the activity (efficacy and safety) of Ertapenem~     administered according to a short treatment for three days versus a short treatment for three~     days with AS in patients with an community acquired IAI of mild to moderate severity.~   "
223703|NCT00630500|"~     A 24-week placebo-controlled parallel group multicentre trial to study the safety and~     efficacy of memantine in patients with dementia associated with Parkinson's disease and~     dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated,~     and more effective than placebo.~   "
223704|NCT00630487|"~     The study will investigate the effect on growth hormone replacement in patients with isolated~     growth hormone deficiency on body composition, especially visceral fat mass.~   "
223705|NCT00630474|"~     Whether impaired nasal breathing contributes to sleep related breathing disturbances has not~     been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a~     drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep~     and nocturnal breathing and daytime performance.~   "
223706|NCT00630461|"~     Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of~     different workplaces, and is even found in homes. The endotoxin used for this study is~     obtained from the National Institutes of Health, and is called Clinical Center Reference~     Endotoxin, or CCRE. The purpose of this Phase 1 research study is to identify a dose of~     inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other~     problems), but causes changes in your sputum cell samples that the scientists can measure.~     Phase 1 research studies like this one are not intended to be a treatment, but are a~     scientific investigation. Eventually, with these types of studies we will be able to examine~     why some people are more sensitive to endotoxin. Scientists at other universities have found~     that while most people do not have a considerable lung response to endotoxin at doses as high~     as 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our~     study is designed to identify if using a dose of 20,000 EU causes changes in the lung cells~     but does not cause symptoms in our study subjects. In our previous studies in our lab, using~     an endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with~     asthma with no major problems, and we have used 10,000 EUs of CCRE in subjects with allergies~     and asthma without problems. We have used 20,000 EUs of CCRE in healthy individuals with no~     major problems.~   "
223707|NCT00630448|"~     Von Willebrand disease is an inherited bleeding disorder that impacts the blood's ability to~     clot properly. Von Willebrand disease is cause by the lack or not working substance in the~     blood known as Von Willebrand factor.~      Current therapy for Von Willebrand disease includes desmopressin acetate (DDAVP) and /or~     VWF/FVIII concentrates. Patients with severe Von Willebrand disease face a lifetime of weekly~     treatments and mounting medical bills. Gene therapy could help these patients improve their~     quality of life by providing the missing factors necessary for the blood's ability to clot~     properly.~      The gene transfer options being studied include naked DNA, viral gene transfer vectors~     encoding Von Willebrand factor transgenes, and ex vivo cell therapy. The latter involves~     transplantation of the patient's own cells modified with a corrected copy of the defective~     gene. Human blood outgrowth endothelial cells (BOEC) display all the properties needed for~     successful ex vivo cell therapy. We plan to obtain blood samples from normal research~     subjects and patients with Von Willebrand Disease in order to isolate blood outgrowth~     endothelial cells (BOEC) from peripheral blood, and develop a ex vivo gene therapy for Von~     Willebrand Disease.~   "
223713|NCT00630370|"~     To assess the efficacy of 3 oral dosing regimens of ATI 7505 compared to placebo in patients~     with PDS by comparing at the end of Day 42 the percentage of patients in each treatment group~     who have had adequate relief of postprandial distress syndrome symptoms on at least 50% of~     the treatment days.~   "
223714|NCT00630357|"~     A cohort of patients who became seizure-free during add-on treatment to one standard AED with~     Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was~     maintained. Tolerability was documented.~   "
223715|NCT00630344|"~     In the treatment of castration-resistant prostate cancer (CRPC), therapies will long response~     durations remain elusive as a result of the inherent ability of prostate cancer cells to~     develop iterative resistance. The goal of this study is to learn if the study drug RAD001~     together with Bicalutamide can slow the growth of prostate cancer. The safety of the~     combination will also be studied.~   "
223716|NCT00630331|"~     The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of~     both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in~     healthy adults 18 to 49 years of age.~   "
223717|NCT00630318|"~     Preliminary imaging study to test for future use of this MRI-imaging for evaluating~     anti-angiogenesis treatment.~   "
223718|NCT00630305|"~     Evaluate the short-term corneal response of oxygen deprivation when using toric contact~     lenses. The response will be noted by endothelial bleb formation in both open eye and closed~     eye state.~   "
223719|NCT00630292|"~     This is a pilot study designed to explore the feasibility of non-invasively diagnosing the~     presence of cancer in the breast using non-invasive magnetic resonance imaging (MRI) methods~     and an analysis of vessel shape defined from these magnetic resonance images.~   "
223720|NCT00630279|"~     This study is to estimate the efficacy of a number of doses in patients with pancreatic~     insufficiency~   "
223721|NCT00630266|"~     The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac~     Support Device (CSD) placed around their heart for the treatment of heart failure at the same~     time as their mitral valve surgery.~      The CorCapTM CSD is intended to support the heart, potentially preventing further dilation~     that is associated with progressive heart failure, thereby potentially preserving or~     improving heart function.~   "
223722|NCT00630253|"~     RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, before a donor stem~     cell transplant helps to remove the patient's cells to allow for the transplant cells to take~     and grow. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. When the healthy stem cells from a donor are infused into the patient, they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells can make an immune response against the body's normal cells.~     Giving antithymocyte globulin and removing the T cells from the donor cells before transplant~     and giving cyclosporine before and after transplant may stop this from happening.~      PURPOSE: This phase I/II trial is studying the side effects of cyclophosphamide, fludarabine,~     and antithymocyte globulin followed by donor stem cell transplant and to see how well it~     works in treating patients with Fanconi anemia.~   "
223723|NCT00630240|"~     Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Transcatheter~     arterial chemoembolization (TACE) is the traditional method for the palliative management of~     patients with HCC. Few previous studies had demonstrated that the serum level of anticancer~     drug from patients treated by TACE was similar to those treated by systemic chemotherapy. The~     defense ability of the patient treated by TACE may thus be influenced by the leakage of~     anticancer drug to the systemic circulation. Since more than 80% patients with HCC also have~     liver cirrhosis, the toxicity for those anticancer drugs with hepatic transformation will be~     increased caused by the cirrhotic liver. The severity of pancytopenia in cirrhosis will be~     exacerbated by the effect of bone marrow suppression caused by anticancer drugs. Patients are~     at high risk for infection and hemorrhage. Therefore, it is of clinical importance to prevent~     or decrease the leakage of anticancer drugs to systemic circulation in patients treated by~     TACE. The procedures of TACE performed by previous studies were not constant and the~     distributions of tumor vessels were not evaluated in detail. The possible risk factors for~     the leakage of anticancer drug have not been investigated. This project will collect 60~     patients with HCC including 30 patients with hepatitis B and 30 patients with hepatitis C.~     The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be~     determined within one hour and at the third day after TACE.~   "
223724|NCT00630227|"~     The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in~     patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially~     screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also~     eligible for participation.~   "
223725|NCT00630214|"~     the increased risk of hypocalcemia following total thyroidectomy plus central neck dissection~     can be minimized by routine administration of oral calcium and vitamin D supplements during~     the early postoperative period.~   "
223726|NCT00630201|"~     Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral~     tablets, patients experience withdrawal and cravings when the variable BPN levels in the~     blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin~     that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study~     will test the safety and efficacy of Probuphine in the treatment of patient with opioid~     dependence. Patients who have completed 24 weeks of treatment in the Randomized,~     Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid~     Dependence, will be re-treated with Probuphine over an additional 24 weeks.~   "
223727|NCT00630188|"~     The purpose of this study is to determine whether an intervention designed to help men share~     decisions about prostate cancer screening with their physician results in better decision~     making, more shared decisions, and changes in intended and actual screening rates.~   "
223728|NCT00630175|"~     The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release)~     12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with~     primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings~     and patient sleep questionnaires.~      The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR~     12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.~   "
223729|NCT00630162|"~     In this two-year study, we will target two high risk groups, including MSM of HIV-infected~     and those of non-HIV-infected. We will avail the serodiagnosis to detect the potential amebic~     carriers in both groups; and use microscopy to detect protozoas other than amebiasis.~     Meanwhile we will also survey the patients' status of sexual transmitted diseases (STD). For~     the amebic carriers, we will apply specific antigen and molecular biologic method to follow~     up the duration of the persistence of fecal amebas. We try to clarify the dynamic change of~     amebic carriage.~   "
223730|NCT00630149|"~     This is a pilot phase II study of locally advanced or metastatic nasopharyngeal carcinoma~     (NPC) with the single drug Alimta. The objective of this study is to assess efficacy and~     safety profiles of Alimta as 2nd line treatment for patients with advanced NPC.~   "
223731|NCT00630136|"~     The purpose of this study is to evaluate the effectiveness of the consent process currently~     used for outpatient endoscopy procedures at our hospital. Results from this study will be~     used to assist in making improvements in the way we communicate with parents, thereby~     enhancing the ability to provide informed consents.~   "
223732|NCT00630123|"~     To investigate the change in brain derived neurotrophic factor (BDNF) between pre and post~     treatment for patients with depression with either ECT or TMS.~   "
223733|NCT00630110|"~     This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with~     docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new~     blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting~     agents are intended to target the differences between these tumor blood vessels and the blood~     vessels in normal tissues.~   "
223734|NCT00630097|"~     Patients treated for methamphetamine dependence have high rates of relapse, and no~     pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d,~     l-2-[(diphenylmethyl)sulfinyl]acetamide) is a novel wake- and vigilance-promoting agent that~     is chemically and pharmacologically dissimilar to CNS stimulants. It is well tolerated and~     has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety~     of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive~     function, has been shown to reduce cocaine use in dependent users, and is safe when~     coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging~     clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for~     methamphetamine dependence.~   "
223735|NCT00630084|"~     Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the~     treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The~     efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its~     impact on the outcome in chronic hepatitis C patients concomitant with malignancy other than~     hepatocellular carcinoma deserve to be elucidated.~      The purposes of this study are:~        1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin~          combination therapy in chronic hepatitis C patients concomitant with malignancy other~          than hepatocellular carcinoma, compare to those without systemic malignancy.~        2. To investigate the role of baseline and on-treatment factors on the response to~          pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C~          patients concomitant with malignancy other than hepatocellular carcinoma.~   "
223736|NCT00630071|"~     The values of laboratory examinations which are useful for the diagnoses of acute~     appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood~     sedimentation rate (ESR). Another laboratory value which has recently received considerable~     attention for the early diagnosis of bacterial infection and sepsis is pro-calcitonin (PCT).~     In recent studies it has been clearly shown that PCT is one of the most important biochemical~     indicators which closely correlates with the severity of inflammatory host response to~     microbial infections. Aim of this open, prospective study is therefore to investigate if PCT~     has an accurate diagnostic value for the diagnosis of acute appendicitis.~   "
223737|NCT00630058|"~     The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and~     other viral characteristics after administration of two arms of MP-424 in combination with~     Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis~     C.~   "
223738|NCT00630045|"~     This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX~     regimen (oxaliplatin plus capecitabine) .~   "
223739|NCT00630032|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) and giving them after surgery may kill any tumor cells~     remaining after surgery. It is not yet known whether docetaxel is more effective than~     ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed~     by docetaxel or ixabepilone to compare how well they work in treating patients who have~     undergone surgery for nonmetastatic breast cancer.~   "
223740|NCT00630019|"~     Compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin~     ophthalmic solution or an active comparator in subjects undergoing cataract surgery.~   "
223741|NCT00630006|"~     The prognosis of chronic hepatitis C virus (HCV)infeciton varies from minimal progressive~     disease to cirrhosis or hepatocellular carcinoma. Host genetic factors contribute to disease~     severity. It is known that cytokine gene (including tumor necrosis factor-alpha (TNF-alpha)~     and interleukin-10 (IL-10) polymorphism affect disease prognosis.This study aims to assess~     the effect of TNF-alpha and IL-10, and their interaction,on prognosis of HCV-related chronic~     liver disease~   "
223742|NCT00629993|"~     Primary care physicians have an important role to play in the delivery of cancer prevention~     and detection services to patients. Face-to-face counseling of physicians, called academic~     detailing, involves a brief and focused intervention, modeled on the practices of~     pharmaceutical companies. This type of intervention may increase physicians' attention to~     preventive opportunities and increase their screening behaviors.~   "
223743|NCT00629980|"~     The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic~     solution, 1% on signs and symptoms of blepharitis.~   "
225324|NCT00608842|"~     The purpose of this research is to compare the safety and effectiveness of 3 different~     concentrations of deoxycholic acid for injection against a placebo in the treatment of~     superficial lipomas.~   "
223744|NCT00629967|"~     The purposes of this study are:~        1. To evaluate whether treatment with peginterferon and ribavirin for 24 weeks is~          sufficient to achieve a sustained virological response (SVR) rate comparable to that~          observed with the standard treatment duration of 48 weeks, in hepatitis C virus genotype~          1 (HCV-1) patients achieving a rapid virologic response (RVR; <50 IU/mL HCV RNA at week~          4) at 4 weeks.~        2. To investigate the role of on-treatment virological responses among patients with 24 or~          48 weeks treatment.~   "
223745|NCT00629954|"~     This is a multi-site prospective epidemiological investigation of cardiovascular disease~     (CVD) among Abuja residents from the rural and metropolitan area.~   "
223746|NCT00629941|"~     The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic~     solution, 1% on signs & symptoms of blepharitis and tear cytokine and eyelid bacterial load~     levels~   "
223747|NCT00629928|"~     Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This~     study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with~     either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.~   "
223748|NCT00629915|"~     The purpose of this study is to determine if people with moyamoya disease who have~     insufficient blood flow are at a higher risk for stroke.~   "
223749|NCT00629902|"~     The purpose of this study is to determine the frequency of prosthesis-patient mismatch after~     mitral valve replacement and its effect on clinical outcomes.~   "
223750|NCT00629889|"~     RATIONALE: Levetiracetam and pregabalin are drugs that treat seizures. It is not yet known~     which drug is more effective in treating seizures caused by primary brain tumors.~      PURPOSE: This randomized phase II trial is studying the side effects and how well~     levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy~     and/or radiation therapy for primary brain tumors.~   "
223751|NCT00629876|"~     The purpose of this study is to determine the safety and tolerability of peginesatide used to~     treat anemia in subjects diagnosed with recurrent non-small cell lung cancer, breast cancer~     or prostate cancer and who also receiving a taxane chemotherapy.~   "
223752|NCT00629863|"~     RATIONALE: Diagnostic procedures, such as endoscopic ultrasound, may help doctors learn the~     extent of stomach cancer or esophageal cancer.~      PURPOSE: This randomized clinical trial is studying how well endoscopic ultrasound works in~     diagnosing cancer in patients with localized stomach cancer or esophageal cancer.~   "
223753|NCT00629850|"~     The purpose of this study is to determine if the use of a respiratory resistance trainer will~     increase respiratory muscle strength, improve sleep quality and improve quality of life in~     individuals with spinal cord injury.~      Hypothesis: Use of the respiratory resistance trainer will improve respiratory muscle~     strength, improve sleep quality, and improve quality of life among individuals with spinal~     cord injury.~   "
223754|NCT00629837|"~     The primary objective of this study is to determine the pharmacokinetic profile after single~     administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22~     mg and 13 mg of liposomes/Kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in~     2.5 mL WFI/1000 IU) in PTPs aged 12 to 60 years with severe hemophilia A.~   "
223755|NCT00629824|"~     Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the~     treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The~     efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its~     impact on the outcome in older patients with chronic hepatitis C deserve to be elucidated.~      The purposes of this study are:~        1. To evaluate the efficacy of pegylated interferon-alpha 2a plus ribavirin combination~          therapy in older patients with chronic hepatitis C~        2. To investigate the safety of pegylated interferon-alpha 2a plus ribavirin combination~          therapy in older patients with chronic hepatitis C~   "
223756|NCT00629811|"~     This is a single-centre, double-blind, Placebo-controlled, randomised trial. Trial subjects~     received four 1cm incisional wounds on the inner aspect of each upper arm (eight in total),~     giving four pairs of anatomically matched wound sites per subject. Each subject acted as~     their own control. One site from each anatomical wound pair was randomly treated with~     intradermally administered avotermin (Juvista:100μL per linear cm of wound site~     pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1,~     400μL per wound site) while the second site was a paired control, treated with Placebo (100μL~     per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin~     post-wounding on Day 0 or Day 1, 400μL per wound site). Wound margins for injection were~     defined as extending 0.5cm from either end of the incision. Four doses of avotermin (Juvista)~     were administered to each subject: 5ng, 50ng, 200ng and 500ng/100μL per linear cm; one dose~     to one wound site per anatomically matched pair of wounds. The second wound site from each~     anatomically matched pair of wounds was dosed with placebo. Allocation of treatment to~     wound-site pairs was randomised and double blinded.~      Primary objective To determine the optimal concentration and dose regimen of Juvista for the~     improvement of the resultant scar when applied to the approximated wound margins of male and~     female subjects following surgical incisions.~      Secondary objective To assess the safety and tolerance of Juvista when applied to the~     approximated wound margins of male and female subjects following surgical incisions.~   "
223757|NCT00629798|"~     This study will see if the researchers can lower that risk by giving the patient Palifermin.~     This drug helps protect the lining of the mouth, throat, and stomach. These areas typically~     get sores or ulcers while the blood cell counts are very low. The patient can get infections~     in or from these sores. Palifermin might also help the immune system recover faster. It is~     currently approved for patients who receive their own stem cells. That is called an~     autologous transplant. This study will test the use of Palifermin for T-cell depleted~     allogeneic stem cell transplants.~   "
223758|NCT00629785|"~     The prevalence of obesity and asthma has increased in recent decades. We investigated the~     relationship between body mass index (BMI) and lung function, and also tried to determine if~     asthma prevalence differs between obese and non-obese children. We propose this~     cross-sectional, retrospective analysis to figure out whether the BMI is associated with~     elevated prevalence of asthma, and how their lung function changes in different BMI groups.~   "
225325|NCT00608829|"~     The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in~     subjects with aneurysms of the descending thoracic aorta.~   "
223759|NCT00629772|"~     Palmoplantar psoriasis is a variant of psoriasis affecting palms and soles. It is one of the~     most debilitating variants of psoriasis which very often interferes with daily activities and~     with the ability to work. This type of psoriasis is very difficult to treat as topicals have~     difficulty penetrating the thick epidermis of palms and soles and are therefore not very~     effective. The response to standard agents (methotrexate, cyclosporine and acitretin) is also~     usually limited. A number of these patients have very severe hand and feet disease with mild~     to no involvement elsewhere on the body.~      Given the efficacy of infliximab in psoriasis, the purpose of this study is to evaluate if~     infliximab is safe and if it will improve severity and quality of life in patients with~     palmoplantar psoriasis, a debilitating variant of psoriasis.~   "
223760|NCT00629759|"~     The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the~     maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 (Pexa-Vec) injected~     within hepatic carcinoma tumors.~   "
223761|NCT00629746|"~     The purpose of this study will explore the advantages of electrodes used for monitoring of~     the recurrent laryngeal nerve (RLN) in thyroid surgery~   "
223762|NCT00629733|"~     Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular~     weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male~     volunteers~   "
223763|NCT00629720|"~     The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin~     (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years~     of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology~     stratified into 2 age groups (2 to 7 years and 8 to 16 years).~      The secondary objectives are to investigate the safety and tolerability of the 2 dose~     regimens and to determine the effect of the 2 dose regimens on detrusor LPP.~   "
223764|NCT00629707|"~     The purpose of this trial is to compare two different rates of fluid administration during~     diabetic ketoacidosis (DKA) treatment in children to determine which fluid administration~     rate is more beneficial for brain metabolism and for preventing or decreasing brain swelling~     during DKA.~   "
223765|NCT00629694|"~     It is not unusual for several children operated for severe adenoid hyperthrophy causing~     breathing problems to have otitis media with effusion simultaneously. It is unknown whether~     adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy~     alone in terms of otitis media related quality of life and recurrence of otitis media several~     months after the operation. For this purpose a randomized trial is conducted including~     children operated for adenoid hyperthrophy and whose otitis media with effusion had caused~     minimal or no symptoms so far~   "
223766|NCT00629681|"~     The purpose of this study is to assess the efficacy and safety of pregabalin for the~     treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)~   "
223767|NCT00629668|"~     The prognosis of Hepatitis B virus (HBV)infection varies from minimal progressive liver~     disease to cirrhosis or hepatocellular carcinoma (HCC).Both viral and host genetic factors~     contribute to disease severity. Cytokine gene polymorphism has been regarded affecting~     prognosis of disease. By detecting HBV genotyping and tumor necrosis factor-alpha~     polymorphism, this study aime to assess their effects and interaction on disease severity of~     HBV-related chronic liver disease and HCC.~   "
223768|NCT00629655|"~     The spinal cord is a very important part of the central nervous system. fMRI can be applied~     to observe functional status of the human spinal cord. Under different conditions, the~     investigators will see different types of fMRI signals within the spinal cord. In resting~     state, the investigators might see active/inactive signals, too.~   "
223769|NCT00629642|"~     A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder~     symptoms due to spinal cord injury or multiple sclerosis~   "
223770|NCT00629629|"~     This study assesses the effectiveness of a nutrition advice programme - The ten steps for~     healthy feeding of children under than two years - on nutritional status and morbidity~     history of children. This is a randomized controlled trial in mostly socioeconomic deprived~     families (intervention=200; controls=300). Mother's of the intervention group received~     dietary counseling in the first year of life. Both groups received routine care by their~     paediatricians and research assessment at 6 and 12 months.~   "
223771|NCT00629616|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the~     body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy~     before surgery may be an effective treatment for breast cancer. It is not yet known whether~     anastrozole is more effective than fulvestrant when given before surgery in treating women~     with breast cancer.~      PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works~     compared with fulvestrant in treating postmenopausal women with stage II or stage III breast~     cancer that can be removed by surgery.~   "
223772|NCT00629603|"~     Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal~     progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that~     host genetic factor may play a role in determining disease progression. It is known that many~     cytokine polymorphisms affect disease progressin via increasing hepatic fibrosis that are key~     factors in progressing liver injury. By combinations of fibrosis-relating gene polymorphisms,~     this study aims to identify patients with high risk for progressive liver disease. These~     patients need intensive therapy to decrease morbidity and mortality of chronic HCV-related~     liver disease.~   "
223773|NCT00629590|"~     The purpose of this study is to evaluate the safety and efficacy of AzaSite ophthalmic~     solution, 1% on signs and symptoms of blepharitis.~   "
223774|NCT00629577|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial is studying gene expression profiling of cervical cancer~     progression in biopsies and tissue samples from patients with cervical lesions.~   "
223775|NCT00629564|"~     This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg~     Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people~     with symptoms of Gastroesophageal Reflux Disease (GERD)~   "
223776|NCT00629551|"~     The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once~     daily in combination with paroxetine 20mg once daily compared to saredutant placebo in~     combination with paroxetine 20mg once daily in patients with major depressive disorder. The~     study also includes a double-placebo group (saredutant placebo in combination with paroxetine~     placebo).~   "
223777|NCT00629538|"~     Transudative pleural effusions are a common manifestation of patients with congestive heart~     failure. Severe dyspnea and respiratory failure may develop in those with large effusions,~     which in general show poor response to medical treatment. Therapeutic thoracenteses (TT) may~     be indicated in these patients and can produce marked relief of symptoms. However, the~     underlying effect of TT on gas exchange and respiratory mechanics in theses patients remains~     unclear. The researchers' hypothesis is that,TT may improve arterial oxygenation and~     respiratory mechanics in patients with congestive heart failure complicated by large pleural~     effusions.~   "
223778|NCT00629525|"~     The purpose of this study is to determine the biochemical response rate (PSA) to single agent~     RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).~   "
223779|NCT00629512|"~     Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This~     study looks at the prevention of these gastric ulcers with one of the three following~     treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once~     daily; versus placebo; in patients at risk.~   "
223780|NCT00629499|"~     This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study;~     however, progression-free survival will be followed and determined for the patients in this~     study. Approximately 50 patients are planned to be enrolled in this study.~   "
223781|NCT00629486|"~     By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine~     gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.~   "
223782|NCT00629473|"~     This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics~     of escalating doses of the proteasome inhibitor NPI-0052 in patients with advanced~     malignancies including solid tumors, lymphomas, leukemias and multiple myeloma. By inhibiting~     proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction,~     which blocks growth and survival in cancer cells.~   "
223783|NCT00629460|"~     Because the management of children with solid tumors hinges on the extent of disease, it is~     crucial to identify metastatic sites. Helical chest computed tomography (CT) is the standard~     method of excluding pulmonary metastases. However, CT lacks molecular information regarding~     nodule histology and often biopsy is required to exclude malignancy. Biopsy procedures carry~     known risks including those associated with anesthesia and sedation, infection, pneumothorax,~     hemorrhage, pain and other post-procedure and post-operative complications and may also add~     unnecessary cost to the management of the patient. We found that the ability of three~     experienced pediatric radiologists to correctly predict nodule histology based on CT imaging~     features was limited (57% to 67% rate of correct classification). Also, there was only slight~     to moderate agreement in nodule classification between these reviewers.~      Furthermore, of 50 children who have undergone pulmonary nodule biopsy at St. Jude in the~     last five years, 44% (22/50) had only benign nodules.~      Adult studies have shown that a nuclear medicine scan called fluoro-deoxyglucose (FDG)~     positron emission tomography (PET) and the fusion modality PET-CT are superior to diagnostic~     CT in distinguishing benign from malignant pulmonary nodules because FDG PET gives~     information about the metabolic activity of the nodule. Nodules that are malignant have more~     metabolic activity, hence more FDG uptake/intensity, than those that are benign. There has~     been little work done in children to determine the value of PET or PET-CT in the evaluation~     of pulmonary nodules.~   "
223784|NCT00629447|"~     To determine the safety of prophylaxis with Tinzaparin low molecular weight heparin in~     primary brain tumor patients. 2. To determine the incidence of deep venous thrombosis or~     pulmonary embolism in brain tumor patients who will be receiving Tinzaparin as primary~     prophylaxis. 3. To determine the overall survival of patients with malignant glioma who~     receive Tinzaparin. 4. To determine the bone density before and after prophylactic~     Tinzaparin.~   "
223785|NCT00629434|"~     This study compares group diabetes education in-person versus via telemedicine~   "
223786|NCT00629421|"~     Although serum alpha-fetoprotein level and abdominal sonography are the main methods to~     screening hepatocellular carcinoma (HCC) in cirrhotic patients, the adequate time and methods~     used are not completely well-defined. This study aims to assess the better timing and methods~     for prospectively screening HCC in patients with cirrhosis~   "
223787|NCT00629395|"~     Specific Aim 1: To assess the feasibility and acceptability of a home-based, computerized~     attention training program with survivors of central nervous system (CNS) impacting pediatric~     cancer (e.g. acute lymphocyte leukemia [ALL], brain tumors).~      Specific Aim 2: To estimate the effect size of this attention training program with survivors~     of childhood cancer to determine whether a larger-scale clinical trial is warranted.~   "
223788|NCT00629382|"~     This clinical study designed as a prospective, open labelled, multi-centre, RCT will be~     carried out to evaluate if direct hemoperfusion with polymyxin B immobilized fiber column~     (PMX) is superior to conventional medical therapy for sepsis, for patients with sepsis~     arising from abdominal cavity infection, accompanied by the failure of one or more organs.~     120 patients (60 treatment/60 control) will be considered in this study. Those patients~     fulfilling inclusion criteria and not having exclusion criteria will be randomly allocated to~     one of two study groups. One group will be treated with PMX (PMX group) and the other will~     receive a standard therapy for sepsis (control group). All patients will receive full~     intensive care management, including fluid resuscitation, vasopressors, antimicrobial~     chemotherapy, ventilatory support, and renal replacement therapy, if required. Each patient~     will be followed up for 28 days after study entry.~   "
223789|NCT00629369|"~     Developing a method to maximize maternal expulsive effort should be of great value in~     reducing the number of cesarean section or instrumental deliveries. Various investigations~     have shown that use of an occlusal support device (OSD) increases the isometric strength of~     different muscle groups. The aim of our study was to investigate the role of an OSD in second~     stage pushing.~   "
228019|NCT00572650|"~     This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in~     patients with mild renal impairment compared to their sex, age and weigh based healthy~     volunteer counterparts.~   "
223790|NCT00629356|"~     Originally test host's to understand the tracking healthily and immune change of the dengue~     fever in Taiwan. Blood drawing 20 c.c for liver examination, kidney and other biochemical~     function, analyze host immunity adjusts and controls the gene, and the reciprocation that may~     be produced with the virus hepatitis, besides collected 10 c.c urine at the same time. Urine~     check is in order to compare acute infect and infected over three month person, the change of~     chemical composition.~      This plan expect to collect 150 healthy, 150 dengue fever infected and 150 dengue fever bleed~     hot or dengue fever shock disease group's patient, goal to understand health state and~     immunity of follow-up adjust and control the difference of the gene and the reciprocation may~     produce to virus hepatitis of light disease and serious disease.~   "
223791|NCT00629343|"~     The purpose of this study is to determine safety and toxicity for the combination of~     Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant~     Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial.~     Patients will be evaluated with complete history and physical as well as laboratory studies~     (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all~     sites of measurable disease. This study will be conducted over the course of 3 years.~   "
223792|NCT00629330|"~     The aims of this project are to adapt and extend the use of academic detailing to the~     dissemination of prostate cancer (CaP) screening findings to primary care physicians~     practicing in African American communities. The objectives of this study are:~      1. To test the hypothesis that a community physician-based educational intervention~     (multi-component academic detailing, including an interactive, digitized, web-based program~     for informed decision-making about prostate cancer, and patient education materials designed~     for low literacy patients) will increase physician knowledge, positive attitudes/beliefs~     toward screening and screening options, and prostate cancer screening (using the digital~     rectal exam, and the serum prostate specific antigen test) at baseline, 6-, and 12-months~     post- randomization, compared to the rate observed in a service- as-usual control.~      1A. To demonstrate the feasibility of disseminating the American Cancer Society guidelines~     for prostate cancer screening among primary care practitioners using multi-component academic~     detailing.~      2. To develop models predicting which physician offices are most and least likely to adopt~     the intervention, and to generate hypotheses about tailoring the dissemination of PC~     screening guidelines to different physician subgroups.~      The long term goal of this project is to increase prostate cancer screening among African~     American communities, thus decreasing cancer-related morbidity and mortality.~   "
223793|NCT00629317|"~     The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite~     in facial photodamage in a randomized double blind trial.~   "
223794|NCT00629304|"~     TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of~     the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or~     telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1~     diabetic patients, despite intensive insulin therapy (multiple daily injections with~     basal-bolus insulin or insulin pump), as compared with conventional care.~      Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months~   "
223795|NCT00629291|"~     Sickle cell anemia and Sickle cell β thalassemia patients require multiple transfusions in~     order to avoid chronic anemia sequel. This regimen entails intrinsic deleterious effects, the~     majority of which are related to iron deposition in the reticuloendothelial system. Thus,~     iron is deposited in hepatic, myocardial and endocrine glands tissues. Tools available for~     iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are~     non specific.~      The purpose of this work is to compare iron overload in the liver, heart and pancreas in~     Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences.~   "
223796|NCT00629278|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as trastuzumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. It is not yet known which regimen of combination~     chemotherapy given together with trastuzumab is most effective in treating breast cancer.~      PURPOSE: This randomized phase III trial is comparing two different regimens of combination~     chemotherapy given together with trastuzumab to see how well they work in treating women with~     HER2-positive stage I, stage II, or stage III breast cancer.~   "
223797|NCT00629265|"~     The purpose of the investigation is to learn whether intense swallowing exercise or intense~     swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had~     head/neck cancer and currently have dysphagia swallow better.~   "
223798|NCT00629252|"~     This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2~     antagonist sertindole modulates or improves both subcortical and cortical information~     processing in schizophrenic patients who had not or insufficiently responded to previous~     antipsychotic medication. This goal shall be accomplished by investigating the effect of~     sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of~     auditory evoked potentials in schizophrenic patients. These effects shall be compared to the~     effect of risperidone and shall also be compared to untreated healthy controls.~   "
223799|NCT00629239|"~     The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable,~     safe and effective in treating COPD and, if so, how it compares with placebo.~   "
223800|NCT00629226|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses~     high energy x- rays to kill tumor cells. Bortezomib and cetuximab may make tumor cells more~     sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving bortezomib together with cetuximab, radiation therapy, and~     cisplatin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with cetuximab and radiation therapy with or without cisplatin in treating~     patients with stage IV head and neck cancer.~   "
223801|NCT00629213|"~     The aim of the study was to analyse the independent and joint effects of the components of~     the metabolic syndrome (MetS) on the incidence of diabetes in people with impaired glucose~     tolerance (IGT) and to assess the effect of acarbose by MetS status.~      Double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. MetS by ATP~     III definition with fasting plasma glucose of ≥ 6.1 mmol/l as limit for impaired fasting~     glucose (IFG).~   "
223802|NCT00629200|"~     Primary Objective:~      -To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in~     combination with IFN alpha2b in patients with advanced malignancies.~      Secondary Objectives:~        -  To correlate the AUC of SSG with clinical toxicity and efficacy.~        -  To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal~          transduction pathways.~        -  To characterize the effects of SSG on PTPases SHP-1 and SHP-2.~        -  To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.~   "
223803|NCT00629187|"~     The goal of this study is to find the maximum dose of a drug, temozolomide, that can safely~     be given to subjects with brain tumors. Past studies showed that the maximum dose of~     temozolomide was limited by low blood counts. The investigators will use blood stem cells~     collected from bone marrow to help subjects recover their blood counts, a procedure called~     autologous stem cell transplant or stem cell rescue. This way, the investigators expect to be~     able to safely deliver very high doses of temozolomide. This study is only available at Tufts~     Medical Center.~   "
223804|NCT00629174|"~     The trial will evaluate the effects of frequent exercise and increased mental activity on the~     age-related impairment of cognitive function in elderly women. Furthermore, we will assess~     the effects of exercise and mental activity on the mood, physical performance and mental~     status of participants. We will also search for genetic factors which may be responsible of~     the observed outcomes.~   "
223805|NCT00629161|"~     This study was designed to evaluate the symptomatic effects or potential disease progression~     slowing down effect of a kind of Traditional Chinese Medicinal Mixture in Parkinson's disease~     (PD) patients. The treatment phase includes 12 months period of Traditional Chinese Medicinal~     Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.~   "
223806|NCT00629148|"~     The primary objective of this study is to evaluate the efficacy and tolerability of~     sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.~   "
223807|NCT00629135|"~     The study is contemplating the antibiotic therapy of intraabdominal abscesses. These~     abscesses are a serious problem in surgical practice. Associated pathophysiologic effects as~     for example peritonitis may become life threatening or may lead to extended periods of~     morbidity with prolonged hospitalization.~      The objective of the sudy is to evaluate whether the combination of Moxifloxacin and~     Metronidazole is equivalent to Piperacillin / Tazobactam with regard to clinical outcome and~     eradication of aerobe and anaerobe pathogens in patients with intra-abdominal abscesses.~   "
223808|NCT00629122|"~     Tacrolimus (Prograf) belongs to a class of medications known as the calcineurin inhibitors.~     It is a maintenance drug that is used to prevent rejection in kidney, liver, and heart~     transplant recipients. Calcineurin inhibitors display high pharmacokinetic (the body's~     effects on a drug) variability and necessitate use of blood tests to ensure that adequate~     drug levels are present to maintain effectiveness and safety. Early after transplant or at~     times when tacrolimus cannot be taken by mouth, alternative routes of administration are~     sought. Although an intravenous (through the vein) product is available, it can be toxic to~     the kidneys and has been associated with allergic reactions. Drug delivery via the oral~     mucosa is an alternative method of systemic drug administration which offers an alternative~     when oral administration is impractical (gastrointestinal dysmotility, reduced drug~     absorption, intestinal failure, difficulty in swallowing, or in those with nausea or~     vomiting). Administration of tacrolimus by the sublingual route may allow for direct entry~     into the systemic circulation and bypasses problems associated with drug absorption and~     breakdown that take place in the small intestine.~   "
223809|NCT00629096|"~     The main aim of the study is to determine whether intracoronary infusion of autologous bone~     marrow mononuclear cells can improve the ventricular function of patients with idiopathic~     dilated cardiomyopathy.Secondary end-points will be:~        1. To evaluate possible changes in patient functional capacity and~        2. to identify the biological characteristics of the bone marrow graft that might influence~          on functional recovery.~   "
223810|NCT00629083|"~     The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid®~     in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency~     (ISD) in adult women who have SUI or stress predominant mixed incontinence~   "
223811|NCT00629070|"~     Our primary aim is to determine whether and how muscle architecture of the quadriceps muscles~     in cerebral palsy (CP) adapts to two separate training programs: traditional strength~     training (ST) vs. velocity-enhanced training (VT). For the ST group, we hypothesize that~     muscle size will increase in conjunction with strength. For the VT group, in addition to the~     above, we hypothesize that fiber length will increase with measures of muscle power. We also~     hypothesize that walking velocity will improve in both groups but that knee motion and step~     length will improve only with VT.~   "
223812|NCT00629057|"~     BNIT-PR-001 is an open-label, multi-center, Phase I dosing evaluation trial of MVA-BN®-PRO in~     men with androgen-insensitive prostate cancer. Patients will have PSA recurrence after being~     treated with androgen suppression therapy or complete androgen blockade.~      The trial will consist of a treatment with up to 6 vaccinations with MVA-BN®-PRO at monthly~     intervals, followed by a 1-year follow-up phase. A vaccination may be 1, 2, or 4 injections~     of study vaccine.~      The study is designed to examine safety as well as the effect of three different doses on~     immune response.~   "
223813|NCT00629044|"~     The aim of this study is to assess the implicitement of the cholesterol 24 S hydroxylase gene~     and the 24 S hydroxycholesterol in glaucoma and in age related macular degeneration.~   "
223814|NCT00629031|"~     It is a randomized, double-blind, multi-center, two-arm study intended to assess the safety~     and efficacy of three different doses/dose regimens of paromomycin administered~     intramuscularly as follows: 11 mg/kg/day for 14 days and 11 mg/kg/day for 21 days for the~     treatment of visceral leishmaniasis (VL) in India.~   "
228058|NCT00572117|"~     The purpose of this study is determine whether the use of topiramate is effective in the~     treatment of alcohol dependence (i.e. decreases drinking) in patients with bipolar disorder.~   "
223815|NCT00629018|"~     Several studies have documented that transplantation of bone marrow-derived cells (BMC)~     following acute myocardial infarction is associated with a reduction in infarct scar size and~     improvements in left ventricular function and perfusion. The available evidence in humans~     suggests that BMC transplantation is associated with improvements in physiologic and anatomic~     parameters in both acute myocardial infarction and chronic ischemic heart disease, above and~     beyond the conventional therapy. In particular, intracoronary application of BMC is proved to~     be safe and was associated with significant improvement in the left ventricular ejection~     fraction (LVEF) in patients with chronic heart failure.~      In contrast to ischemic heart failure, the data on effects of BMC transplantation in patients~     with dilated cardiomyopathy are limited to pre-clinical studies. In a rat model of dilated~     cardiomyopathy, intramyocardial delivery of pluripotent mesenchymal cells improved LVEF,~     possibly through induction of myogenesis and angiogenesis, as well as by inhibition of~     myocardial fibrosis, suggesting that the beneficial effects of stem cell transplantation in~     dilated cardiomyopathy may primarily be related to their ability to supply large amounts of~     angiogenic, antiapoptotic, and mitogenic factors. Similarly, transplantation of cocultured~     mesenchymal stem cells and skeletal myoblasts was shown to improve LVEF in a murine model of~     Chagas disease.~      Study Aim:~      To define the clinical effects of BMC transplantation in dilated cardiomyopathy in a pilot~     clinical study investigating the effects of intracoronary CD34+ cell transplantation on~     functional, structural, neurohormonal, and electrophysiologic parameters in patients with~     end-stage dilated cardiomyopathy.~   "
223816|NCT00629005|"~     People with stroke experience weakness and incoordination. Studies have shown that with~     functional task practice, people can increase motor control and strength to a certain extent.~     This study will investigate whether adding progressive resistance strength training to~     functional task practice modeled after Constraint-Induced Movement Therapy results in greater~     motor function gains than functional task practice alone~   "
223817|NCT00628992|"~     Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic~     obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is~     more costly and they are more prone to nosocomial infection.In addition, they are longer~     bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and~     skeletal muscle weakness which curtails simple daily activity.The principal purpose of this~     study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh~     and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose~     is to analyse the effects of each type of rehabilitation on muscular fiber (structural and~     functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the~     intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to~     receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh~     (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the~     thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks~     with 5 sessions per week.In each group of patients, muscular biopsies will be done under~     local anaesthesia at the beginning and end of the rehabilitation programme and when they are~     discharged from the service.~   "
223818|NCT00628979|"~     The purpose of this study is to understand some of the reasons why recently deployed veterans~     decline psychosocial treatment options for panic disorder and to test a brief weekend~     treatment for panic attacks.~   "
223819|NCT00628966|"~     An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the~     chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms.~     The LifeVest is a new non-invasive, wearable defibrillator that is an alternative to an ICD.~     This two-part study will evaluate the effectiveness of the LifeVest at reducing arrhythmias~     in people who have recently had a heart attack. The study will also develop methods to~     determine who may benefit the most from receiving an ICD.~      NOTE: NHLBI only provides support for the PREDICTS part of the study.~   "
223820|NCT00628953|"~     The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of~     subjects with persistent asthma believed to have acid reflux as a contributory factor to~     control of their asthma.~   "
223821|NCT00628940|"~     The aim of the study is to define preferential sites of tumour recurrence by observing tracer~     uptake in the tumour in sequential PET images with 18F-fluoromethylcholine (and perfusion MR,~     see also below). Changes in the intensity of the tracer uptake in the tumour during and after~     the course of radiotherapy will be correlated with the site of tumour recurrence as will be~     assessed by conventional MRI. In due time, these results must enable clinicians to change~     their therapeutic approach of high-grade glioma.~   "
223822|NCT00628927|"~     The purpose of this study is to determine whether performance on neurocognitive measures~     predicts treatment outcomes in individuals with substance abuse disorders. A second purpose~     is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in~     people with substance abuse disorders to that of people who do not have substance abuse~     disorders.~   "
223823|NCT00628914|"~     Preliminary studies suggest that the response to antidepressant medication can be accelerated~     by targeting insomnia with adjunctive use of eszopiclone. It is not yet known what~     mechanism(s) support this acceleration in response, though preliminary findings support the~     hypothesis that early restoration of sleep may facilitate BDNF-based effects of~     antidepressant medications. The optimal duration of co-treatment is also unknown. This study~     will test specific hypotheses about brain mechanisms and evaluate the effects of continued~     eszopiclone beyond the time window when response acceleration should be observed.~   "
223824|NCT00628901|"~     The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres~     and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with~     symptomatic uterine fibroids.~   "
223825|NCT00628888|"~     This study will evaluate the effectiveness of an emotion-focused cognitive behavioral~     treatment program for adolescents with anxiety or unipolar depressive disorders.~   "
223863|NCT00628381|"~     The purpose of this study is to study the stimulating effects of prolonged (8h) enteral~     L-citrulline supplementation on the normalisation of the plasma citrulline concentrations and~     the Arginine-NO metabolism, the microcirculation, the systemic hemodynamics, vascular~     permeability, and organ function and disease severity scores.~   "
223826|NCT00628875|"~     This study is a prospective, observational case series of a convenience sample of~     mechanically ventilated pediatric patients in the Pediatric ICU, Progressive Care Unit and~     Operating Room at the Children's Hospital of Philadelphia.~      We propose to observe, measure and report the accuracy, precision and bias of defibrillator~     electrode pads to detect breathing in stable but critically ill and mechanically ventilated~     children. This study will provide preliminary data to inform the resuscitation research~     community and assist development of evidence-based pediatric resuscitation guidelines in the~     future.~   "
223827|NCT00628862|"~     The purpose of this study is to show the efficacy and safety of formoterol for the~     maintenance treatment of patients with COPD compared with placebo in patients in Japan and in~     European countries during 12 weeks.~   "
223828|NCT00628849|"~     Patients who sustain a broken lower jaw have traditionally been treated in one of three ways.~     The first involves having their teeth and jaws being wired together for a period of 4 to 6~     weeks in order to allow the broken jaw to heal. The second and third ways involve a surgical~     procedure that requires exposing the broken bones and stabilizing them with metal plates and~     screws that allow the patient to be able to function relatively normally during the healing~     period. One surgical method uses small plates and screws while the alternate method uses~     large plates and screws. Currently there are two schools of thought with respect to what~     plates and screws should be used. One group supports the use of large rigid plates due to the~     increased strength of the plate. The use of the larger and stronger plates is the principle~     behind the AO technique, which was originally developed in the 1970's in Switzerland and is~     now the more popular technique in the USA. The other group supports the use of smaller plates~     and screws which must be placed in certain anatomical positions to allow the natural muscular~     forces that exist on the jaw to stabilize the break and facilitate complete healing of the~     broken bone. This technique was developed in France by Maxime Champy in the 1970's and is the~     standard of care throughout Australasia and parts of Europe. This technique is simpler,~     quicker and cheaper. The need for patients to maintain a diet with softer foods is considered~     by many to be important for success if the less rigid and smaller plates are going to be~     used. Many critics of the Champy technique feel that less compliant patient populations as~     might be seen in a county hospital make the technique less readily suited to these~     populations. This is contrary to published data from Europe, Australia and recently the USA.~      The question of interest is whether the smaller plates and screws are equally as effective in~     the treatment of broken lower jaws in an urban county hospital? If they are equally~     effective, then is there any benefit in terms of fewer patient complications and decreased~     health costs? If the smaller plates and screws are not adequate, then will a modification of~     the original Champy technique improve their usefulness? Patients who present with a broken~     lower jaw who require surgery will be treated in one of three ways. Some patients will be~     treated with the larger plates and screws by an attending surgeon who routinely uses large~     plates and screws for broken lower jaws. Another group of patients will be treated with the~     smaller plates and screws using the Champy principles. A third group of patients will also be~     treated with the smaller plates and screws but using a modification of the original Champy~     technique that involves the use of additional small plates and screws for added stability.~     Patients will then be followed over a three month period to evaluate for healing of the~     broken jaw. The three techniques will be then be compared.~      Larger plates/ screws and the smaller plates/ screws are both the standard of care. Regional~     differences throughout the USA has continued to ensure differences of opinion with regard to~     which technique is better although historically the larger plates/screws has been more~     popular in the USA.~   "
223829|NCT00628836|"~     The study looks at treatments for reversing chronic shoulder subluxation after a stroke. It~     compares electrical stimulation with surface electrodes (stimulation through the skin) with~     intra-muscular stimulation (from inside the muscle)using an implanted micro-stimulator~     (BION). Subjects are put either in a surface stimulation or a BION® group. In the BION®~     group, two BION®s are implanted in the shoulder, the medial deltoid and supraspinatus~     muscles. Treatment consists of a baseline of 6 weeks, and 6 weeks of therapy, consisting of 2~     sessions per day for 10 to 30 minutes each time. This is followed by 6 weeks without therapy.~     If testing shows that after 6 weeks of therapy there is no reversal of subluxation, more~     intense therapy is carried out for another 6 weeks. Treatment is similar in the surface~     electrode group, but surface electrodes deliver the stimulation instead of BION®s. A total of~     30 subjects is expected to complete the study.~   "
223830|NCT00628823|"~     The main purpose of this study is to evaluate the natural history of gluten sensitivity in~     endomysial antibody positive adults with celiac disease suspicion, who were found to have a~     only mild enteropathy (Marsh I-II) in the small-bowel mucosa. The investigators hypothesize~     that these subject are indeed gluten-sensitive, as measured by clinical, serological and~     histological indicators. If this would be the case, the current diagnostic criteria for~     celiac disease might need re-evaluation.~   "
223831|NCT00628810|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as bevacizumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by~     blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy~     together with bevacizumab and to see how well it works in treating patients with metastatic~     colorectal cancer.~   "
223832|NCT00628797|"~     Systemic scleroderma (SSc) is a rare chronic inflammatory diseae of the connective tissue~     involving the skin and internal organs. To date there is no proven therapy for the skin~     fibrosis available. A number of case reports and small uncontrolled cohort studies suggest~     that UVA1 therapy may improve skin fibrosis. The aim of this study is therefore to~     investigate whether treatment UVA1 in deed is effective in treating skin fibrosis in SSc~     using a randomized, intraindividual half body irradiation protocol.~   "
223833|NCT00628784|"~     In this prospective single center study, up to 25 patients with Barrett's esophagus with LGD~     or no dysplasia (Group 1), 25 patients with HGD/IMCA (Group 2), 25 patients with esophageal~     carcinoma confined to the esophageal wall (Group 3) and 25 patients with severe esophageal~     squamous dysplasia (Group 4) will be treated with endoscopic cryotherapy. This study is~     single arm and no blinding will be utilized. Interim analysis of the data will be reviewed~     with a DCI statistician after 14 patients in each group have been treated with cryotherapy~     and if safety and efficacy is documented to that point in time, we will request the ability~     to extend the enrollment to a maximum allowable amount of 25 patients per group. The proposed~     study duration is seven years, allowing two years for patient enrollment and 5 years for post~     treatment follow-up. Study duration per patient will total approximately six years.~      Patients with Barrett's esophagus with no dysplasia or low grade dysplasia (group 1) will be~     treated with cryotherapy at six week intervals until Barrett's mucosa is ablated or six~     treatments are administered. Patients with Barrett's HGD and IMCA or severe esophageal~     squamous dysplasia (groups 2 and 4) will be treated with cryotherapy at six-week intervals~     until Barrett's mucosa is ablated or six treatments are administered. More advanced mass~     lesions are typically more difficult to eradicate with ablative therapies and may progress~     faster than patients with IMCA, therefore, patients with more advanced cancer (group 3) will~     be treated every 2 weeks until the lesion is eradicated up to eight treatments.~      After cryotherapy treatment is complete (i.e. the esophagus has re-epithelialized with normal~     squamous epithelium for Groups 1, 2, 4 and the tumor is locally controlled/absent in Group~     3), patients will be assessed by endoscopy and biopsy every three months for one year, every~     six months for two years, then annually for two years (flow sheet - appendix 1; study~     schedule - appendix 2).~   "
223834|NCT00628771|"~     This study will evaluate the effectiveness of CenteringPregnancy Plus, a group prenatal care~     treatment program with an HIV/sexually transmitted disease prevention component, in reducing~     health risk behaviors in pregnant teenagers seeking services at Community Health Centers in~     the New York metropolitan area.~   "
223835|NCT00628758|"~     The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with~     treatment according to conventional best practice in adult patients with persistent asthma.~   "
223836|NCT00628745|"~     THAOS is a global, multi-center, longitudinal observational survey open to all patients with~     transthyretin-associated amyloidoses (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM~     (cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years.~     Patients will be followed as long as they are able to participate.~      The principal aims of this outcome survey are to better understand and characterize the~     natural history of the disease by studying a large and heterogenous patient population.~     Survey data may be used to develop new treatment guidelines and recommendations, and to~     inform and educate clinicians about the management of this disease.~   "
223837|NCT00628732|"~     The purposes of this study include:~        -  Determination of the change in clearance of topotecan and topotecan lactone between day~          1 and day 14 for patients receiving treatment with p.o. topotecan and p.o.~          cyclophosphamide x 14 days.~        -  Determination of the correlation between the activity of CYP3A4, as measured by the 14C-~          Erythromycin Breath Test (ERMBT), and topotecan/topotecan lactone clearance for patients~          receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.~        -  Determination of the response rate to oral cyclophosphamide and oral topotecan in~          recurrent and/or refractory pediatric solid tumors.~        -  Obtain additional safety data for the chemotherapy regimen, p.o. topotecan and p.o.~          cyclophosphamide x 14 days.~        -  Report the frequency of severe toxicities associated with the level of CYP3A4 activity,~          as measured by the ERMBT, for patients receiving treatment with p.o. topotecan and p.o.~          cyclophosphamide x 14 days.~   "
223838|NCT00628719|"~     The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the~     treatment of Visceral Leishmaniasis (VL) in India.~   "
223839|NCT00628706|"~     The purpose of this study is to determine whether THC, the main psychoactive ingredient in~     cannabis, affects functional brain systems underlying memory and reward.~   "
223840|NCT00628693|"~     The design of this protocol is a prospective observational study to objectively measure the~     rate, depth and quality of chest compressions and ventilations delivered during cardiac~     arrest in the Pediatric Intensive Care Unit (PICU) and Emergency Department (ED) settings~     utilizing the MRx/Q-CPR. The data collected will be analyzed for several purposes - for~     comparison with current American Heart Association (AHA) Cardiopulmonary Resuscitation (CPR)~     guidelines and to determine chest wall stiffness for CPR modeling efforts and construction of~     biofidelic manikins or test dummies for CPR and auto safety.~   "
223841|NCT00628680|"~     The purpose of this study is to determine if AAT-023 (Zuragen) solution is superior to~     Heparin in preventing Catheter Related Blood Stream Infections for End Stage Renal Disease~     patients.~   "
223842|NCT00628667|"~     This study looks at how effective acid suppression therapy is on symptoms associated with~     chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.~   "
223843|NCT00628654|"~     RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding~     ovarian epithelial cancer.~      PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer~     in women with ovarian epithelial cancer and in healthy female participants.~   "
223844|NCT00628628|"~     Primary Objectives:~      To determine the efficacy of rasburicase administered as a single dose followed by as needed~     dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm)~     in the treatment of patients at high risk or potential risk for tumor lysis syndrome.~      Secondary Objectives:~        1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days~        2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities.~        3. To determine the safety and immunogenicity of rasburicase.~        4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).~   "
223845|NCT00628615|"~     Rationale:~      The sensation of the need for urination (urge) is a complex and only partially understood~     mechanism. It is our hypothesis that this mechanism is disrupted in patients suffering from~     overactive bladder syndrome.~      The Overactive Bladder syndrome (OAB) has been defined as a spectrum of symptoms in which~     incontinence may or may not overlap with urgency, frequency and nocturia. This syndrome is~     estimated to affect approximately 17% of the adult population in Europe and the United~     States. The symptoms of overactive bladder have many potential causes and contributing~     factors. One of these factors is an outlet obstruction of the bladder due to benign prostatic~     hyperplasia (BPH). Nowadays antimuscarinic drugs are used for treatment of the overactive~     bladder. Antimuscarinic agents have been proven to work slightly to moderately better than~     placebo's and are associated with side effects such as a dry mouth, blurred vision and~     constipation.~      Many patients with lower urinary tract symptoms (LUTS) develop OAB. In this group of patients~     with LUTS and OAB, there is not always a clear obstruction found. So, at least in some~     patients, with LUTS, there must be another reason for OAB than obstruction.~      The autonomous bladder activity has been introduced by, among others the Maastricht Urology~     research group. In animal models, the bladder is shown to have rhythmic low amplitude~     contractions (micro motions). It is hypothesized that this activity has a sensory function in~     the micturation regulation system which is mainly located in the bladder wall. These so~     called micromotions have never been demonstrated in the human bladder. The sensing function~     of the bladder and the micturation reflex remain mainly unclear. We hypothesise that there is~     a disregulation of the autonomous bladder activity (micro motions) in patients with OAB.~      We want to explore and study the relationship between OAB, obstruction and the micro motions~     in order to gain a better understanding of the bladder (patho)physiology. reason for This on~     its turn, can help us in the quest for better treatment strategies for patients suffering~     from OAB.~      Objective:~      The study is divided in two distinct groups a male and female group:~      The male group consist of patients with lower urinary tract symptoms (LUTS). The female group~     consist of patients with the overactive bladder syndrome OAB.~      The primary objective of this pilot experiment is to describe via an observational study the~     relation between non-micturation bladder activity and sensation during the filling phase of~     the bladders in women. We want to explore if there is a relation between non-micturation~     bladder activity and the sensation of urgency during the filling phase.~      Furthermore in men, we want to study the relationship between non-micturation bladder~     activity and the amount of obstruction.~      We would also like to visualize the micro motions of the bladder in both men and women during~     filling phase and study the influence of (visual and cognitive) stimuli on bladder activity.~      We want to explore if there is a relation between non-micturation bladder activity and the~     sensation of urgency during the filling phase in male patients with Lower urinary tract~     symptoms. In order to gain a better understanding in bladder (patho)physiology.~      Study design: A pilot observational study to describe the non-micturation bladder activity~     and sensation measurement during filling phase.~      Study population:~      The study population consists of two groups. First a group of patients (female) who will~     undergo an ambulatory urodynamic investigation to investigate their bladder complaints. All~     patients will be older than 18 years.~      The second group consists of male patients who will undergo a conventional urodynamic~     investigation in the normal work up for their lower urinary tract symptoms. All patients will~     be older than 18 years.~   "
223846|NCT00628602|"~     Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the~     soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has~     been demonstrated to activate strong muscle contractions and to produce skeletal motion, with~     associated increases in muscle bulk (hypertrophy), strength, and metabolic capacity, hence~     counteracting the 3 major etiological factors in PU development (immobility, soft-tissue~     atrophy and hypoxia).~      This study intends to use neuromuscular stimulation to both shift paralyzed subjects' weight~     and build up gluteal muscle volume, in order to prevent recurrence of pressure ulcers. We~     will implant BIONs alongside the already exposed inferior gluteal and sciatic nerves in~     patients who are undergoing gluteal rotation flap surgery for PU reconstruction. The gluteal~     rotation flap is a common reconstructive technique for treating PUs by bringing healthy~     muscle and skin in to repair the deficient area, and to provide healthy tissue covering over~     bony prominences. The implanted BIONs will enable us subsequently to stimulate the gluteus~     maximus and hip extensor muscles. Outcome measures will include tissue health variables~     (measured by clinical assessment, X-Rays, MRI and Sesta-MIBI SPECT perfusion scans), pressure~     redistribution (measured by an array of pressure sensors), and recurrence rates over 12~     months.~   "
223847|NCT00628589|"~     Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in~     schizophrenic patients~   "
223848|NCT00628576|"~     The purpose of the study was to evaluate efficacy and safety of the new acute treatment of~     deep venous thrombosis by use of low-molecular-weight heparin compared with standard~     treatment using unfractionated heparin, especially concerning long-term morbidity.~   "
223849|NCT00628563|"~     This is a retrospective observational study utilising anonymised individual patient clinical~     and prescribing information routinely collected by UK General Practitioners (GPs). This~     information will be observed for two years, one year pre and one year post- Index~     Prescription Date (IPD). The IPD is the date when a patient was first switched to any option~     of the step-3 asthma treatment regimen. The one year before the IPD is the baseline period~     and will be reviewed for risk factors and confounding factors. The one year after the IPD is~     the outcome period and will be observed to see the outcomes of the new treatment.~   "
223864|NCT00628368|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This clinical trial is studying how well biological factors work in predicting~     response to treatment in patients with esophageal cancer or rectal cancer.~   "
223850|NCT00628550|"~     Cardiac arrest has a very poor prognosis, especially with prolonged efforts at resuscitation,~     and unfortunately, survivors are often severely neurologically impaired. CPA in children is~     often the result of a prolonged illness rather than a sudden, primary cardiac event as is~     frequent in adults. This necessitates that resuscitation research must be conducted~     separately for pediatric and adult patients. Authorities currently endorse the use of~     epinephrine for restoring spontaneous circulation based on its ability to maintain diastolic~     blood pressure and subsequent blood flow to the heart during resuscitation. However, human~     studies have shown no clear survival benefit of epinephrine and have elucidated concerning~     adverse effects. Recently, both the European Resuscitation Council and the American Heart~     Association have recognized the use of vasopressin as a promising vasoconstrictor and an~     alternative or adjunct to epinephrine in the resuscitation of adults. Vasopressin causes~     profound vasoconstriction without the adverse effects of epinephrine and is associated with~     improved blood flow to the heart and brain. This increased cerebral blood flow has been~     associated with better neurologic outcome in animal studies. In light of compelling animal~     and human studies of combined vasopressin and epinephrine, pediatric trials are indicated for~     vasopressin usage in pediatric CPR. This study will evaluate the addition of the~     administration of vasopressin to standard advanced CPR therapy (epinephrine alone) for~     pediatric patients that experience in-intensive care unit CPA to assess for improved time to~     return of spontaneous circulation (ROSC), survival to 24 hours, survival to hospital~     discharge, and neurologic outcome. When a patient experiences a CPA, standard Pediatric~     Advanced Life Saving (PALS) protocols as endorsed by the American Heart Association will be~     initiated. This will include receiving epinephrine as the first vasopressor medication.~     Patients will then be randomized to receive vasopressin (treatment group) or epinephrine~     (control group) as the second vasopressor medication, if needed. If more then two doses of~     vasopressor medication is required in either group, epinephrine will be administered~     according to the PALS algorithm until the end of the event. All CPA events meeting inclusion~     criteria will be entered into the National Registry of Cardiopulmonary Resuscitation (NRCPR)~     Database, which tracts all CPA events at Children's Medical Center Dallas. Prior to~     commencement of the RCT, a pilot trial of 10 patients will be completed to assess preliminary~     safety, feasibility, and effectiveness of combination epinephrine-vasopressin for pediatric~     in-intensive care unit CPA refractory to initial epinephrine dosing. All pilot patients will~     receive vasopressin as the second vasopressor medication.~   "
223851|NCT00628537|"~     The study looks at a new treatment for wrist and finger contractures -- a condition where the~     affected hand is in a closed position, with the wrist and fingers stiff and difficult to~     move from that position. We want to study if stimulation of wrist and finger muscles using an~     implanted neuromuscular stimulator (BION) will be more or less effective than doing passive~     exercises of the affected hand to improve the range of movement at wrist and finger joints.~     Subjects of this study will be randomized into one of three groups: one doing passive~     movement therapy; one receiving surface stimulation (electrical stimulation with electrodes~     on the skin of the arm) and one doing BION® therapy. The passive movement group will do~     therapy for 12 weeks. Subjects in either stimulation group will receive stimulation for 6~     weeks and then only passive therapy for 6 weeks.~   "
223852|NCT00628524|"~     The purpose of this study is to prospectivly analyze the correlation of triglyceride~     tolerance and glucose tolerance with cardiovascular morbidity and mortality in patients with~     stable coronary artery disease within 18 months and to determine, whether measurement of~     triglyceride tolerance can discriminate patients at risk for cardiovascular events.~   "
223853|NCT00628511|"~     portable monitoring device could diagnose sleep apnea in high risk patients.~   "
223854|NCT00628498|"~     Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD.~     Defibrotide is no longer available though the Emergency Use IND mechanism (also known as~     compassionate use, or single patient named use). This protocol is the only mechanism by which~     Defibrotide can be made available to patients in the U.S.~   "
223855|NCT00628485|"~     The primary goal of the proposed study is to improve the long-term swallowing capabilities of~     subjects undergoing radical or modified radical neck surgeries followed by chemoradiation~     therapy (CRT), by more selective stimulation of the swallowing muscles using implanted~     microstimulators called BIONs.~   "
223856|NCT00628472|"~     This single blinded randomized pilot study was performed on 21 Caucasian females to determine~     if injections through follicular openings were less painful than traditional injections for~     cosmetic botulinum toxin type A injections.~   "
223857|NCT00628459|"~     Some micronutrients are likely to interact with malaria parasite, leading to either~     synergistic or antagonist effect on malaria morbidity and therefore on hemoglobin response.~      The purpose of this study is to investigate the effect of supplementation with iron or~     multiple micronutrients on anemia while integrated with malaria management in rural Burkinabe~     young anemic children with high prevalence of malaria.~   "
223858|NCT00628446|"~     This study includes male subjects age 45 to 70, who have sustained a traumatic Spinal Cord~     Injury (SCI) at least 10 years prior. Subjects will be interviewed for demographic data,~     including heart disease risk factors. A blood test for cholesterol levels will be drawn. A CT~     scan of arteries of the heart will be performed to determine the presence of coronary~     calcium, a marker of subclinical Coronary Heart Disease. Scoring of Coronary Calcium or~     Coronary Calcium Score (CCS) is automated by the CT scanner. Each subject's Framingham Risk~     Score will be calculated; This is an individuals 10 year risk of having a Coronary Heart~     Disease event (significant symptoms). In addition, it will be determined if subjects are~     being treated for diagnosed dyslipidemia (high cholesterol) according to the National~     Cholesterol Educational Program (NCEP) guidelines.~      The proposed pilot study aims to better understand the problem of Coronary Heart Disease in~     individuals with Spinal Cord Injury, specifically CCS in SCI, when compared to the general~     population.~   "
223859|NCT00628433|"~     The purpose of this pilot, exploratory study is to evaluate the safety, tolerance,~     pharmacokinetics and potential activity of an investigational agent, HE3286, when~     administered orally, daily for 28 days to patients with mild-to-moderate ulcerative colitis.~   "
223860|NCT00628420|"~     To determine the safety and tolerability of ACP-104 after oral administration of single doses~     in comparison with placebo to schizophrenia or other psychotic disorders.~   "
223861|NCT00628407|"~     This protocol is a prospective, pilot, observational study in the Pediatric Intensive Care~     Unit (PICU), Progressive Care Unit (PCU) and the Operating Room (OR) settings at the~     Children's Hospital of Philadelphia (CHOP). We propose to observe, measure and report the~     effect of incremental gentle sternal pressure increases on intrathoracic pressure, and other~     surrogates of hemodynamic function, in stable mechanically ventilated children. This study~     will provide preliminary data to inform the resuscitation research community and assist~     development of evidence-based pediatric resuscitation guidelines in the future.~   "
223862|NCT00628394|"~     This research is being done because people with schizophrenia often have problems with~     thinking including learning, remembering, paying attention, and problem solving. During this~     study, we will test if cognitive remediation (computer games made to improve thinking), used~     along with a drug called atomoxetine, may help the problems in thinking as well as some of~     the symptoms of schizophrenia.~   "
223865|NCT00628355|"~     Our hypothesis is that with comparison of effectiveness of two most common techniques of~     treatment for myofascial pain syndrome (injection of local anesthesia and ischemic~     compression) we could choice the most adequate to treat this disease. This way we could~     decrease the expenses with medicines, examinations, consultations and the time that women~     remains without a diagnosis and treatment.~   "
223866|NCT00628342|"~     This study includes patients with sleep disturbances associated with gastroesophageal reflux~     disease (GERD) and has 3 treatment arms. Patients will receive only one of the following~     treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching~     placebo once daily. The relief to the sleep disturbances will be assessed.~   "
223867|NCT00628329|"~     We wish to understand the association of Vitamin A serum levels and Vitamin A receptor number~     and responsiveness in asthmatics. We believe that Vitamin A receptors may be less prevalent~     in asthmatics and their responsiveness decreased.~   "
223868|NCT00628316|"~     Caffeine intake is reported by many authors to enhance the perception of tinnitus. The aim of~     this study is to determine the effects of 1 month caffeine intake reduction in the scores of~     validated questionnaire Tinnitus Handicap Inventory (THI) and in a visual-analog scale (VAS).~   "
223869|NCT00628303|"~     The primary objective of this study is to assess the efficacy of motavizumab compared to~     placebo when administered monthly to preterm infants during their first RSV season for the~     reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd~     birthdays.~   "
223870|NCT00628290|"~     A controlled, randomized study on the treatment of schizophrenic psychosis with cannabidiol,~     a phytocannabinoid is performed. This approach is based upon recent findings indicating that~     the human endogenous cannabinoid system is significantly involved in the pathogenesis of~     schizophrenia. Our group has shown, for example, that Δ9-tetrahydrocannabinol (Δ9-THC) is~     able to provoke schizophrenia-like psychotic symptoms in healthy volunteers. This, as well as~     the capability of Δ9-THC to exacerbate productive psychotic symptoms in schizophrenic~     patients, has recently been confirmed by others. Furthermore, we found that the en-dogenous~     brain constituent anandamide, an endogenous Δ9-THC agonist, is significantly elevated in the~     CSF of schizophrenic patients. Cannabinergic substances such as anandamide may enhance~     dopaminergic neurotrans-mission by increasing dopamine turnover. They may also influence the~     onset or course of schizophrenia by as yet unidentified mechanisms We seek to investigate the~     efficacy of cannabidiol in the treatment of schizophrenic and schizophreniform psy-choses,~     because there is evidence that CB1 antagonists such as SR141716 and cannabidiol have~     antipsychotic effects comparable to those of classic neuroleptic drugs. Furthermore,~     cannabidiol is well tolerated showing few side effects in humans. Cannabidiol may serve as an~     antipsychotic medication that is not primarily based upon an antidopaminergic but upon~     different mechanisms, especially anticannabinergic ones. It may therefore be an effec-tive~     medication in at least a subgroup of schizophrenic and schizophreniform patients and may be~     expected to show additional anxiolytic effects and only minor side effects.~      The control condition in this parallel design will be an established neuroleptic treatment~     with amisulpride that is primarely an antidopaminergic drug. Thus, we will study not only the~     antipsychotic efficacy of cannabidiol, but we will also compare the effects of both treatment~     strategies on side effects and neuropsychological functioning.~   "
223871|NCT00628277|"~     We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight~     loss counseling would lead to a greater loss of fat mass and a greater improvement in~     cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation~     exercise plus counseling.~   "
223872|NCT00628264|"~     The purpose of the present research study is to investigate for the first time, the safety~     and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary~     bypass graft and/or valve repair or replacement surgery. AP214, the investigational drug, is~     being developed to potentially prevent post-surgical kidney injury after thoracic aortic~     aneurysm repair.~   "
223873|NCT00628251|"~     The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281~     against liposomal doxorubicin to see which is effective and well tolerated in treating~     patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed~     previous platinum therapy.~   "
223874|NCT00628238|"~     The study is a two-arm, multi-center trial of Revlimid® and Rituximab, for the frontline~     treatment of patients with Chronic Lymphocytic Leukemia (CLL) designed and conducted by the~     CLL Research Consortium (CRC). The purpose of this study is to determine the response rate of~     the combination of Revlimid® and Rituximab in previously untreated CLL patients in two arms-~     those aged 65 years and above and those younger than 65. Secondary objectives will evaluate~     the safety of the combination of Revlimid® and Rituximab, response duration, improvement in~     hematologic parameters, and the significance of the tumor flare reaction. All patients will~     have assessment of known prognostic factors for CLL as well as novel prognostic factors will~     be evaluated for predicting response to treatment. Biologic corollary studies are designed to~     evaluate the mechanism of Revlimid® in CLL and the combination of Revlimid® and Rituximab.~   "
223875|NCT00628225|"~     Background: Smoking cessation is the key element in the treatment of patients with Chronic~     Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these~     patients with successful quitting smoking was suboptimal. Therefore we evaluated the~     effectiveness of two smoking cessation programs (counseling and nicotine replacement) for~     smokers with COPD in routine general practice, one with (CNB) and one without (CN) the~     combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD~     symptoms in successful smoking cessation.~      Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The~     usual care group (UC) consisted of 148 patients (22 practices), the first intervention group~     (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second~     intervention group of 276 patients (25 practices. Main outcome measure was (biochemically~     verified) point prevalence.~   "
223876|NCT00628212|"~     The purpose of this study is to evaluate the efficacy and safety and to determine the~     appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with~     type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration~     once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment~     manner.~   "
223877|NCT00628199|"~     This is a research study in which your cells will be used for somatic cell nuclear transfer~     (SCNT), and/or genetic reprogramming research which may result in the production of stem cell~     lines. This study does not provide treatment.~   "
223878|NCT00628186|"~     The purpose of this study is to determine which stent type is effective in the decrease of~     postoperative stay and complications across pancreaticojejunostomy after~     pancreaticoduodenectomy.~   "
223929|NCT00627497|"~     The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM~     Spinal Stabilization System as a method of treating patients with symptoms of degenerative~     lumbar spinal stenosis at a single level from L2 to L5.~   "
223879|NCT00628173|"~     Purpose:To compare the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation in the~     superior versus inferior quadrants.~      Methods: In a non-randomized clinical trial and over a period of two years, consecutive~     patients with refractory glaucoma underwent AGV implantation in the superior or inferior~     quadrants. Main outcome measures included best corrected visual acuity (BCVA), intraocular~     pressure (IOP), number of glaucoma medications, complications and success rate (defined as at~     least 30% IOP reduction below preoperative values and 5<IOP<22 mmHg with or without glaucoma~     medications). Other criteria for failure included implant removal, additional glaucoma~     surgery, phthisis bulbi or loss of light perception.~   "
223880|NCT00628160|"~     Septic shock is a frequent and severe complication in cirrhosis. Current mortality rate~     ranges between 50 and 80% of cases. Refractory shock, hepatorenal failure and variceal~     bleeding are the main causes of death of these patients. Terlipressin administration could~     prevent these complications and improve survival in this setting.~      Aim: To evaluate the effects of terlipressin administration on hospital survival in cirrhotic~     patients with severe sepsis or septic shock.~      Methods: Prospective, open labelled, controlled trial evaluating 72 cirrhotic patients with~     severe sepsis or septic shock who will be randomized to receive terlipressin plus~     alpha-adrenergic drugs or only alpha-adrenergic drugs at shock diagnosis. Patients will be~     submitted to continuous systemic hemodynamic monitoring (S. Ganz catheter or Vigileo).~     Changes in vasoactive systems and cytokines levels will be also evaluated.~   "
223881|NCT00628147|"~     The purpose of the study is to determine if colonoscopic examination using a colonoscope with~     a narrow band imaging light is more effective at detecting polyps compared to a colonoscope~     with standard full spectrum white light.~   "
223882|NCT00628134|"~     Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are~     performing this study to determine whether inhaled medications dissolved in surfactant-based~     solutions will distribute more evenly throughout the lungs when compared to standard~     saline-based solutions. We think that inhaling medication that is in a surfactant-based~     liquid will result in more medication reaching partially blocked parts of the lung. This~     study will use a special nuclear medicine test called an aerosol deposition scan to compare~     how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based~     aerosol.~   "
223883|NCT00628121|"~     GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in~     healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when~     administered in a single dose have been investigated in studies conducted using doses of 1, 3~     and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix~     rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent~     prolongation of the duration of LH suppression. However, there have been few reports of~     studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the~     present study, we investigated the effect of cetrorelix on LH surge when this drug was~     administered in single doses of 1, 2 and 3 mg.~   "
223884|NCT00628108|"~     To determine the safety of levocetirizine in children ages 6-11 months with symptoms of~     allergic rhinitis or chronic idiopathic urticaria.~   "
223885|NCT00628095|"~     CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells.~     Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18~     that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped~     that taking this drug will reduce the symptoms of rheumatoid arthritis~   "
223886|NCT00628082|"~     Up to half of all patients with heart failure are found to have normal pumping function of~     the heart muscle, but show abnormalities in the way the heart muscle relaxes and fills with~     blood. These patients often have high blood pressure, and tend to have stiff arteries and~     stiff heart muscle. We wish to test the hypothesis that these patients have abnormal energy~     stores in their heart muscle.~   "
223887|NCT00628069|"~     Based on the motor learning theories, it is hypothesized that bench-model training will allow~     junior residents to be more interactive than trainees lacking similar active hands-on~     training.~   "
223888|NCT00628056|"~     Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood~     vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may~     also contribute. We plan to study the mechanisms involved in this abnormal metabolism, whilst~     also assessing the effects of a drug called Perhexiline which improves the abnormal~     metabolism that is present in diabetic patients before the development of heart failure.~   "
223889|NCT00628043|"~     This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU~     compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to~     anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.~   "
223890|NCT00628030|"~     The percentage of overweight children between the ages of 6 and 11 has nearly tripled in the~     last three decades, and rates are even higher among African Americans.Overweight children are~     at-risk for numerous health problems, thus effective treatments are urgently needed. This~     study will evaluate an innovative intervention for ethnically diverse parents (NOURISH),~     which focuses on helping parents role model and teach their children healthy behaviors.~   "
223891|NCT00628017|"~     This preliminary study is aimed to investigate whether it is feasible to conduct a study to~     use fish oil compared to the placebo(olive oil) in people with cognitive impairment. We will~     also explore whether fish oil has better efficacy in some clinical aspects in people with~     cognitive impairment during 24 weeks intervention. The major clinical outcome will be:~        1. general clinical impression~        2. cognitive function~   "
223892|NCT00628004|"~     The objective of this open label extension study (extension to study DK143WS) is to evaluate~     the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety~     follow-up period.~   "
223930|NCT00627484|"~     This study is designed to compare the changes in insulin sensitivity as well as~     gastrointestinal hormone levels in diabetic and non-diabetic obese individuals who are~     undergoing weight loss procedures. The main hypothesis of this study is that weight loss~     induced by gastric bypass will induce a greater improvement in insulin sensitivity compared~     with gastric banding or low calorie diet. Subjects will be studied before and after weight~     loss. Studies consist of intravenous glucose tolerance test, body composition analysis, meal~     test, and energy expenditure.~   "
223893|NCT00627991|"~     Patients who are suffering from a stroke often present to the hospital with elevated blood~     pressure. Elevated blood pressure in the setting of stroke increases the risk of brain~     swelling or bleeding into the brain. Even so, there has been concern about lowering the blood~     pressure with medications because the newly injured parts of the brain may not get the blood~     flow they need, thereby worsening the damage from the initial stroke. We hope to demonstrate~     that the drug valsartan can be used safely and modestly to lower blood pressure in acute~     stroke patients, without having a detrimental effect on brain blood flow or neurologic~     status. Novel MRI techniques to measure brain blood flow will be used in conjunction with~     clinical scales to demonstrate safety.~   "
223894|NCT00627978|"~     Primary Objectives~        -  Assess ultrastructure changes in dermal myelinated nerves of patients who receive~          ixabepilone chemotherapy~        -  Detailed characterization of peripheral neuropathy in patients who receive ixabepilone~      Secondary Objectives~        -  Clinical benefit rate~        -  Time to progression ( TTP)~        -  Toxicity~        -  Exploratory studies:~             -  Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic~               changes observed in neurons.~             -  Relation of NGF, IL8, and IL10 to the development of clinical symptoms and~               ultrastructural changes in neurons.~   "
223895|NCT00627965|"~     The purpose of this study is to determine whether regular oral use of sildenafil citrate can~     prevent or attenuate high altitude illnesses.~   "
223896|NCT00627952|"~     Eight-week multi-national, multicenter, randomized, double blind, active control, two arms,~     parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase~     followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril)~     phase.~   "
223897|NCT00627926|"~     A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in~     combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).~   "
223898|NCT00627913|"~     In this study, the investigators plan to compare the incidence and complications of~     intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients taking~     tamsulosin (Flomax) and treated with retrobulbar injection of anesthesia, versus injection of~     Healon 5 viscoelastic into the anterior chamber.~   "
223899|NCT00627900|"~     Since the advent of coronary stents, in-stent restenosis has proven to be the major~     limitation of interventional cardiology, occurring in as many as 30% of patients.~     Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis.~     They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer,~     and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel~     wall and stops the process of neointimal hyperplasia, thereby significantly reducing the~     incidence of in-stent restenosis.~      The study Prevention of Coronary Restenosis examines the effectiveness of sirolimus-eluting~     stents (SES) compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal~     of the study is to examine whether the guideline-supported implantation of SES, despite the~     higher initial cost, improves the quality and economic outcomes of the treatment of patients~     with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment~     of daily activities, re-intervention rate, as well as an account of the utilisation and~     benefits of the implemented standardised guidelines.~      In this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an~     implantation of a SES for treatment of coronary stenosis were recruited from 35 hospital~     centres. Their treatment and outcomes will be evaluated over a 3-year period by means of~     standardised questionnaires. In addition, information obtained from the patients will be~     confirmed and augmented by telephone interviews with the attending physicians involved in~     their follow-up care.~      In order to appraise the effect of the new therapy, a comparison cohort group of 394 patients~     receiving a BMS was recruited. These patients will be evaluated and observed by the same~     method as those patients receiving a drug-eluting stent, also over 3 years~   "
223900|NCT00627887|"~     The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is~     safe and effective in relapse prevention of depression.~   "
223901|NCT00627874|"~     The purpose of this study is to assess whether a short-term imposed myopic defocus is~     effective in preventing the development and progression of juvenile-onset myopia in Chinese~     children.~   "
223902|NCT00627861|"~     Antihypertensive drug treatment is effective in only about 50% of patients. One mechanism~     responsible for treatment failure is a drug related stimulation of the~     renin-angiotension-aldosterone-system (RAAS). Several classes of medications that treat~     hypertension by blocking the RAAS system have been developed. However, the kidney responds to~     these drug treatments by producing greater amounts of renin. This high level of renin can~     reduce the effectiveness of some of these medications, ultimately causing the blood pressure~     to rise. This is one reason why blood pressure can be difficult to control in a certain~     percentage of patients.~      The hypothesis to be tested in the proposed study is that beta-adrenergic blockade~     (β-blockade), when superimposed upon aliskiren, a drug that competitively inhibits plasma~     renin activity (PRA) but stimulates the release of renin by the kidneys (plasma renin~     concentration [PRC]), can suppress the reactive increase in PRC that occurs during aliskiren~     monotherapy.~      The primary aim of this study is to measure plasma renin concentration (PRC) and plasma renin~     activity (PRA) levels during renin inhibition with aliskiren and combined renin~     inhibition/β-blocker treatment to determine whether the addition of a β-blocker attenuates~     the rise in plasma renin concentration (PRC). A secondary aim is to determine whether~     combined treatment further suppresses PRA and blood pressure.~   "
223903|NCT00627848|"~     The purpose of the study is to investigate the effect of rivastigmine given as an acute dose~     compared to placebo and after 1 month chronic dosing on fMRI response during a face~     recognition task. Furthermore, the aim is to investigate whether fMRI response is correlated~     with long term treatment effect at 6 months and 12 months.~   "
223904|NCT00627835|"~     The purpose of this study is to assess the safety and determine MTD (maximal tolerated doses)~     and recommended doses of neoadjuvant sorafenib (BAY 43-9006) and concurrent sorafenib,~     cisplatin and radiation in the locally advanced squamous cell carcinomas of the head and neck~     (SCCHN)patient population.~   "
223905|NCT00627822|"~     The purpose of this study is to assess patient and companion acceptability of medical~     education in a non-teaching private hospital~   "
223906|NCT00627809|"~     The investigators hypothesized that complementary intracoronary streptokinase administration~     to primary percutaneous intervention in patients with acute myocardial infarction may provide~     limitation infarct size and improvement in left ventricular volumes and function in acute and~     late phases (6 months).~   "
223948|NCT00627250|"~     The purpose of this study is to determine if amantadine hydrochloride given 100 mg in the~     morning and at noon is safe and effective in the treatment of mood and behavior changes (i.e.~     irritability) after sustaining traumatic brain injury.~   "
223907|NCT00627796|"~     Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg~     was developed in order to further extend the duration of the release of the active~     ingredient. The ATG formulation consists of a solution of lanreotide in water with no~     additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg~     doses and provided a prolonged dosing interval and good tolerability (1). In some previous~     studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as~     octreotide-LAR in patients with acromegaly (4-7).~      Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking.~     Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This~     information is particularly useful in the setting of first-line therapy of acromegaly that is~     currently becoming a more frequent approach to the disease (8). It is demonstrated that~     approximately 80% of the patients treated with depot somatostatin analogues as first line~     have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A~     definition of significant tumor shrinkage was provided in 14 studies (including a total~     number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of~     patients receiving first-line somatostatin analogues therapy for acromegaly had a significant~     reduction in tumor size (10). About 50% of the patients were found to have a greater than 50%~     tumor shrinkage within the first year of treatment (10); in this study we found that percent~     decrease in IGF-I levels was the major determinant of tumor shrinkage (10).~      The current open, prospective study is designed to investigate the prevalence and amount of~     tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.~   "
223908|NCT00627783|"~     DYNAMIT is a prospective, randomized, multicenter, open strategy trial run in 45 French~     hospitals. Diabetic patients with no evidence of coronary artery disease and at least 2~     additional cardiovascular risk factors are randomized to screening for silent ischemia using~     a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N=316),~     or follow-up without screening (N=315). All have access to cardiovascular prevention~     according current guidelines. The main end point is time to death from all causes, non-fatal~     myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or~     emergency service intervention.~   "
223909|NCT00627770|"~     The purpose of this study is to evaluate the applicability and measurement properties of~     bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty~   "
223910|NCT00627757|"~     The purpose of the study is to determine whether antipsychotic treatment is influence~     psychiatric patients due to endocrine and metabolic status and a quality of life.~      The investigators expect, that 30-50% of patients will show pharmacon - gene induced weight~     gain (> 7% of initial bodyweight) while the rest of patients will maintain unaltered~     bodyweight.~   "
223911|NCT00627744|"~     A three months, double-blind, randomised, parallel-group study evaluating the efficacy of~     sitagliptin (Januvia™) versus placebo on beta-cell function in patients with newly detected~     glucose abnormalities and acute myocardial infarction or unstable angina pectoris.~      Primary endpoint Improvement in beta-cell function measured by means of the insulinogenic~     index (ΔI30/ΔG30) obtained from an oral glucose tolerance test (OGTT).~      Secondary endpoints~        1. Improvement of glucose tolerance by means of an OGTT~        2. Improvement in endothelial function~        3. Improvement in incretin-independent beta-cell function measured as the Acute Insulin~          Response (ΔAIRG) during an intravenous glucose tolerance test~   "
223912|NCT00627731|"~     A comparison of oral prednisolone administration with intravenous methylprednisolone infusion~     in the treatment of acute asthma exacerbation in hospitalized patients. Oral~     glucocorticosteroids administration may be effective as intravenous high-dose~     methylprednisolone infusion.~   "
223913|NCT00627718|"~     Age Related Macular Degeneration (ARMD) is the most common cause of irreversible blindness in~     people of age 50 or older in the western populations. ARMD has two forms, the wet and the dry~     forms. The wet form is more serious and can lead to irreversible loss of vision. In the wet~     form of ARMD, new blood vessels grow under the retina. These blood vessels leak blood and~     fluid and cause the retina and the macula to swell. So the thickness of the macula increases.~      One of the key factors in the treatment of wet ARMD is early diagnosis and treatment to~     prevent complete visual loss. In this research, we are going to use a technique, called the~     Heidelberg retinal tomograph (HRT) to measure and compare the thickness of the macula in~     healthy controls and in patients suspected of having ARMD. HRT is a non-invasive imaging~     system that uses laser to measure the thickness of the macula. This allows us to come up with~     a quite simple and easy-to-use technique that helps us to diagnose wet ARMD early and treat~     it before visual acuity is completely lost.~   "
223914|NCT00627705|"~     The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC)~     in children with Autism. NAC is a compound that increases the levels of Glutathione, the~     body's main antioxidant. Glutathione is a compound in the blood that is part of a natural~     defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by~     internal toxins called free radicals. It is possible that children with Autism tend to have~     lower levels of glutathione, an important compound in our bodies that helps combat the~     effects of toxic free radicals.~      We hope that by studying the antioxidant system in more detail, we will increase our~     understanding of the reasons why people develop Autism so that we can design better ways to~     treat individuals with this condition. This study is meant to test the safety tolerability of~     NAC and its effectiveness in the treatment of behavioral difficulties in children with~     autism. It will also examine the possible benefit of this agent in improving the core~     deficits in autism such as social deficits.~   "
223915|NCT00627692|"~     The purpose of this study is to determine whether prucalopride is safe and effective in the~     treatment of constipation in elderly subjects living in a nursing facility.~      Hypothesis:~      Prucalopride up to a dose of 4 mg once daily is safe and well tolerated in in elderly~     subjects living in a nursing facility.~   "
223916|NCT00627679|"~     The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses~     of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy~     volunteers.~   "
223949|NCT00627237|"~     The purpose of this study is to determine the efficacy of an intensive short term cognitive~     rehabilitation program aimed towards improving executive functioning in individuals with~     traumatic brain injury (TBI).~   "
223917|NCT00627666|"~     RATIONALE: Giving chemotherapy before a donor bone marrow stem cell transplant helps stop the~     growth of cancer cells. Chemotherapy and antithymocyte globulin stop the patient's immune~     system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving cyclosporine and methotrexate after transplant may~     stop this from happening.~      PURPOSE: This phase II trial is studying how well giving donor stem cell transplant together~     with busulfan, fludarabine, and antithymocyte globulin works in treating patients with~     hematological cancer.~   "
223918|NCT00627653|"~     The purpose of this study is to determine if treatment with a drug called fenofibrate, which~     is a PPAR-alpha agonist and controls how the heart metabolizes fats, will reverse the~     age-related decline in cardiac fat metabolism and mechanical function.~   "
223919|NCT00627640|"~     Parkinson's Disease is a major neurodegenerative disorder in which there is a progressive~     loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA)~     deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that~     crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the~     major DA metabolising enzyme in man.~      Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and~     safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a~     stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.~      The principal efficacy measure is the increase in mean daily on time during the 18-hr diary~     recording period.~   "
223920|NCT00627627|"~     To evaluate the antitumor activity following treatment with IPI-504 in patients with breast~     cancer.~   "
223921|NCT00627614|"~     RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an~     effective method of diagnosing breast cancer.~      PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in~     diagnosing breast masses in women with a breast mass or breast cancer.~   "
223922|NCT00627588|"~     The primary objectives of the trial are to assess the safety and efficacy of ProSavin.~      Patients in the trial will have been diagnosed with Parkinson's disease and will be failing~     on current treatment with L-DOPA but they will not have progressed to drug-induced~     dyskinesias. The first stage is an open-label dose escalation to evaluate up to three dose~     levels of ProSavin in cohorts of three patients each. Following a recommendation by the DMC~     the study may proceed to the second stage of the trial, a further 12 patients will be~     recruited to confirm efficacy of the optimal dose in the randomized phase of the study.~      The efficacy of ProSavin will be assessed using the Unified Parkinson's Disease Rating Score~     (UPDRS). Patients will be monitored at regular intervals, with the primary endpoint being an~     efficacy assessment at six months after treatment. The secondary objective of the trial is to~     asses the extent to which patients' current therapy (L-DOPA) can be reduced following~     administration of ProSavin.~   "
223923|NCT00627575|"~     This study will evaluate the amount of the cholesterol-lowering drug atorvastatin available~     in the bloodstream, when taken together with the anti-seizure drugs lamotrigine or phenytoin.~   "
223924|NCT00627562|"~     1. Patients included will have benign or malignant lesions with treatment plan for~          endoscopic resection or resection by other minimally invasive techniques.~        2. They will be offered a robotic approach to their surgery using the DaVinci robotic~          surgical system (intuitive Surgical, Inc.).~        3. The objectives are to evaluate our ability to adequately visualize the surgical field~          and perform the intended surgery without a higher complication rate.~        4. Secondary objective include evaluation of blood loss, length of hospital stay,~          complications while using the DaVinci robot system, and quality of life in subjects and~          historical controls undergoing similar surgery without the robot or radiation therapy.~        5. To evaluate recurrence, survival and other outcome data in robotic surgery patients~          compared with similar historical control groups (matched with respect to stage, prior~          and subsequent treatment, age, tumor HPV positivity) of patients who have undergone~          standard surgery without the robot or radiation/chemoradiation treatment as an~          alternative to surgery.~      5. Endpoints will be compared to historical controls.~   "
223925|NCT00627549|"~     Summary:~      Vaginal prolapse is a well-known disease and is observed in approximately 11% of all~     postmenopausal women and tending to increase with age. Consequently, many surgical procedures~     have been developed in order to ensure sufficient support for the bladder, rectum or vaginal~     vault depending on the site of the defect. However, many procedures are associated with a~     high recurrence rate up to 40 % even within one to two years after the surgical procedure.~      Due to the high recurrence rate new methods include the use of mesh, either biologically or~     synthetic. The latter is a permanent implant and therefore theoretically may result in a~     long-lasting anatomically correct position of the prolapse.~      Although the recurrence rate may be lower using a mesh such surgical procedures may be~     associated with adverse events such as erosions of the vaginal mucosa. Others have observed~     shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used.~     In contrast the recurrence rate is lowered up to 25%.~      The above-mentioned advantage of synthetic mesh is however, mostly based on few~     non-randomised studies. We therefore find it of importance to evaluate whether a surgical~     procedure using a mesh implant is superior to conventional surgical techniques. The present~     study is a clinical controlled study where patients with anterior vaginal prolapse are~     randomised to either a mesh technique or a standard anterior procedure.~      The present study includes only two more visits at the outpatient clinic after the surgical~     procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and~     faecal leakage and sexual habits.~      Any participation in the study is totally voluntary and the patient may at any time withdraw~     herself. In any case the patient will receive our standard treatment.~      The study is performed in all the Scandinavian countries.~   "
223926|NCT00627536|"~     This study was undertaken to investigate the scar-improvement efficacy and safety of a single~     dose of avotermin (Juvista) injection into skin incisions.~   "
223927|NCT00627523|"~     To demonstrate the effect on height and psychomotor development of Growth Hormone treatment~     in very young children starting at an age of 2 years.~   "
223928|NCT00627510|"~     Compliance with treatment is notoriously low in psychiatric patients. Traditional methods of~     monitoring compliance, however, may underreport nonadherence to treatment. In this study,~     actual plasma levels at admission - which are ROUTINELY taken at the Dept Psychiatry of the~     Paracelsus Medical University - were compared to plasma levels that can be expected from the~     prescribed preadmission dosing regimen. This was done to give treating psychiatrists a~     quantitatively precise idea of how frequently they can expect their patients to have plasma~     levels that are below the level of medication as intended by the prescribing physician.~   "
223950|NCT00627211|"~     Comparison on the effect on patient pain and discomfort by using CO2 instead of air for~     insufflation during gastroscopy.~   "
223931|NCT00627471|"~     To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with~     insulin glargine on an algorithm with insulin naive patients starting with insulin glargine~     on the physician's standard practice.~      To compare in terms of FBG insulin naïve patients starting with insulin glargine on an~     algorithm with insulin naïve patients starting with insulin glargine on the physician's~     standard practice.~      To compare the percentage of patients achieving HbA1c< 7% in each treatment group.~      To compare hypoglycaemic events (minor, severe and nocturnal) between groups.~      To compare average insulin dose between groups.~      To compare PRO (patients' reported outcomes) between groups.~      To compare mean changes in body weight between treatment groups.~   "
223932|NCT00627458|"~     The purpose of this booster study is to evaluate, in subjects primed in the primary study~     106786, the persistence, at the time of the booster vaccination, of antibodies elicited by~     the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will~     also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This~     protocol posting deals with the objectives and outcome measures of the booster phase. The~     objectives and outcomes measures of the primary phase are presented in a separate protocol~     posting (NCT = 00376779).~   "
223933|NCT00627445|"~     This trial is conducted in Asia. The trial aims to investigate if the blood glucose control~     of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin~     aspart 30 both in combination with metformin.~   "
223934|NCT00627432|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with~     oxaliplatin works compared to gemcitabine alone in treating patients with locally advanced or~     metastatic bladder cancer.~   "
223935|NCT00627419|"~     To evaluate the antitumor activity of IPI-504 in patients with metastatic melanoma.~   "
223936|NCT00627406|"~     The purpose of this study is to possibly further improve the clinical outcome and explore the~     incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in~     GnRH antagonist IVF/ICSI cycles~   "
223937|NCT00627393|"~     Neutropenia, a condition characterized by an abnormally low number of infection-fighting~     white blood cells called neutrophils, commonly develops in people who have undergone~     chemotherapy or hematopoietic stem cell (HSC) transplantation. The severely reduced immunity~     of those with neutropenia can put them at risk of entry of life-threatening infections,~     making the implementation of treatments that increase white blood cell numbers important.~     Several studies have shown that the transfusion of donor granulocytes, a type of white blood~     cell that includes neutrophils, is effective in promoting the recovery of adequate numbers of~     granulocytes. However, granulocyte transfusions can cause side effects, and it is not known~     whether the success of the therapy outweighs the health risks of the side effects. This study~     will evaluate the safety and effectiveness of granulocyte transfusions in treating people~     with a bacterial or fungal infection during neutropenia.~   "
223938|NCT00627380|"~     We are testing the safety and efficacy of a 16-wk yoga lifestyle intervention on oral glucose~     tolerance, fasting lipid/lipoprotein levels, body composition, cardiovascular function,~     quality of life, CD4+ T-cell counts and viral load in HIV-infected men and women with~     components of The Metabolic Syndrome. We hypothesize that a yoga lifestyle intervention will~     improve metabolic, anthropometric, cardiovascular disease parameters, and quality of life~     domains without adversely affecting immune or virologic status in people living with HIV.~   "
223939|NCT00627367|"~     Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an~     additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and~     no more adverse events than patients receiving non-protocolized pain management.~   "
223940|NCT00627354|"~     RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. It is not yet known which drug is more effective in killing~     tumor cells.~      PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to~     etoposide or vinorelbine works as second-line therapy in treating patients with metastatic~     prostate cancer that did not respond to hormone therapy.~   "
223941|NCT00627341|"~     This study will compare the effectiveness of two types of psychotherapy, a relapse prevention~     program and cognitive behavioral therapy, in reducing relapse and fear of eating situations~     in people with anorexia nervosa.~   "
223942|NCT00627328|"~     Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker~     patients with and without previously diagnosed AT.~   "
223943|NCT00627315|"~     This project will study the effects of surgery for obesity on bone metabolism and hormones~     that regulate appetite.~   "
223944|NCT00627302|"~     To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.~   "
223945|NCT00627289|"~     Chronic postherniotomy pain affects every day activities in 5-8% of patients. However, no~     established treatment for this pain syndrome exists and previous reports on the effect of~     surgical intervention suffer from methodological problems. The neurophysiological~     characteristics suggest that pain arises from deeper neuronal structures injured during~     surgery or by ongoing inflammation from the mesh. This study investigates the effect of~     removing inserted mesh and compressed nerves on pain related daily impairment of activities~     assessed by the validated AAS questionnaire before and 6 months after surgery~   "
223946|NCT00627276|"~     RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One~     type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect~     the growth of abnormal breast cells.~      PURPOSE: This randomized pilot trial is studying how well omega-3 fatty acids work in~     treating women with newly diagnosed ductal carcinoma in situ and/or atypical ductal~     hyperplasia.~   "
223947|NCT00627263|"~     An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the~     chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms.~     Arrhythmias can be caused by many factors, including stress and anger. This study will~     evaluate the use of a stress reduction treatment (SRT) program aimed at reducing the~     occurrence of arrhythmias that require treatment with an ICD shock.~   "
223951|NCT00627185|"~     This is a randomized, controlled trial (RCT) to test the efficacy of an internet continuing~     dental education intervention designed to increase tobacco cessation counseling in dental~     practices. The intervention involves surveying practices regarding preventive care, surveying~     adult patients about their tobacco habits and preventive care provided by dental practice and~     training/educating the dentist and office staff on tobacco cessation. With patients who smoke~     and indicate that they have quit, we followed up with testing their saliva for the presence~     of cotinine. We have enrolled general dentists and periodontists who practice in the~     Southeastern United States.~   "
223952|NCT00627172|"~     Multislice CT angiography is a novel but already established and widely used in diagnosing~     coronary artery disease (CAD). It is very reliable in ruling out hemodynamically significant~     narrowings in coronary arteries (Negative predictive value). However, it may overestimate the~     severity of the stenoses in up to 30% of the coronary artery lesions (positive predictive~     value 70%). However, when coupled with a functional or flow-sensitive diagnostic test, such~     as PET perfusion or coronary doppler ultrasonography, one can assume that even the PPV may be~     as high as 95 %. Despite this assumption, there`s no scientific evidence to support use of~     such hybrid multi-modality tests at present.~      The investigators hypothesis is that improving the diagnostic accuracy of non-invasive~     diagnosis of coronary artery disease will decrease the proportion of patients that need~     catheter angiographies. The avoidance of these unnecessary invasive procedures will improve~     patients´ quality of life and may even redirect health care resources in a more efficient~     way.~   "
223953|NCT00627159|"~     Research has shown that the presence of heart disease and stroke is higher in the Indo-Asian~     population compared to other ethno-cultural groups. This may be due to multiple reasons such~     as a higher presence of diabetes, high blood pressure, high cholesterol, obesity, and lower~     levels of physical activity.~      This program will bring together the Calgary Indo-Central-Asian communities and the Calgary~     Healthcare community to help reduce the rate of heart disease and stroke through a~     supportive, culturally-sensitive program that is community-based through the following steps:~        1. Increase awareness of heart disease and stroke through education among the Calgary~          Indo-Central-Asian population.~        2. Identify early, the risk factors related to heart disease and stroke through screening~          programs.~        3. Provide appropriate follow-up care to the population at risk for heart disease and~          stroke.~   "
223954|NCT00627146|"~     Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of~     beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical~     onset of disease that persists until 48 months after administration.~      The investigators also hypothesize that in type 1 diabetic patients with recent clinical~     onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18~     and 48 months after administration, based on assessment of clinical and laboratory adverse~     events.~   "
223955|NCT00627133|"~     Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients~     with alcohol related seizures.~   "
223956|NCT00627120|"~     To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.~   "
223957|NCT00627107|"~     The ReWalk enables people with lower limb disabilities to carry out routine ambulatory~     functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such~     as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other~     severe walking impairments. The device promises to restore the dignity of disabled persons,~     enabling them to work and improve their general health and quality of life, as well as~     significantly reduce medical and other related expenses.~   "
223958|NCT00627094|"~     The objective of this investigation is to demonstrate the effectiveness and safety of Biatain~     Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.~   "
223959|NCT00627081|"~     The association of general anesthesia and of thoracic epidural anesthesia is used in thoracic~     surgery with a demonstrated benefit on the risk of postoperative respiratory complications.~      The objective of the study is to analyze the influence of thoracic epidural administration of~     chirocaine (5 mg/ml) on the administration of anesthetic agents (propofol and remifentanil),~     these drugs being administrated using a closed-loop system with the Bispectral Index as the~     controller.~      Two groups of patients are compared:~        -  one group will receive general anesthesia and thoracic epidural administration of~          saline. Chirocaine will be administered before patient's awakening,~        -  one group will receive general anesthesia and thoracic epidural administration of~          chirocaine (5 mg/ml).~      In both groups, the closed-loop system ensures that le depth of anesthesia is similar in both~     groups.~   "
223960|NCT00627068|"~     Our main hypothesis is that EPC function is impaired in some populations with high~     cardiovascular risk as a result of reduced eNOS-dependent NO production.~   "
223961|NCT00627055|"~     To evaluate the efficacy and safety at 48 weeks between LPV/r monotherapy and 2 NRTIs + LPV/r~     therapy in patients failing a standard NNRTI-based treatment regimen. Also, to evaluate the~     short-term 24-week efficacy and safety of Lopinavir/ritonavir (LPV/r) monotherapy and 2~     NRTIs+LPV/r therapy in patients failing a standard NNRTI-based treatment regimen as an~     interim analyses when 50% of the patients in each arm have reached 24 weeks after~     randomization. Last, to define risk factors for monotherapy failure in HIV-treated~     individuals~      Hypothesis. The rate of virologic suppression is not inferior in the monotherapy arm.~   "
223962|NCT00627042|"~     A study to determine how long ramucirumab (IMC-1121B) will stop cancer from growing in~     participants with liver cancer that cannot be treated with surgery.~   "
223963|NCT00627029|"~     This is a Congressionally mandated study. In the original study, 16 demonstration programs~     provided care coordination services to beneficiaries with chronic illness in Medicare's~     fee-for-service program. A five-year CMS-funded study tested whether the programs can improve~     patients' use of medical services, improve patients' outcomes and satisfaction with care, and~     reduce Medicare costs. The study also assessed physicians' satisfaction with the programs.~      In 2008 Congress extended the project for two of the original programs--Mercy Medical Center~     - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare~     beneficiaries and provide care coordination services into the spring of 2010.~   "
223964|NCT00627016|"~     The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is~     effective in treating patients with night heartburn.~   "
223965|NCT00627003|"~     The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with~     placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with~     RLS. Also, additional objective and subjective sleep parameters and quality of life will be~     assessed.~   "
223966|NCT00626990|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving radiation therapy~     together with temozolomide may kill more tumor cells. It is not yet known whether giving~     temozolomide during and/or after radiation therapy is more effective than radiation therapy~     alone in treating anaplastic glioma.~      PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after~     radiation therapy to see how well it works compared to radiation therapy alone in treating~     patients with anaplastic glioma.~   "
223967|NCT00626977|"~     The aim of the present study was to examine, for pain relief during labor, the efficacy of~     two pharmacological approaches — the 0.125% ropivacaine alone and the 0.0625% ropivacaine~     added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother~     and newborn was also determined.~   "
223968|NCT00626964|"~     The changes in risks of developing coronary heart disease in patients with morbid obesity~     after different weight loss interventions have not been extensively studied. The primary~     objective of this study is to investigate whether an intensive lifestyle intervention program~     in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with a 7-week~     low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular~     disease in these patients.~   "
223969|NCT00626951|"~     The LMA Supreme is a new extraglottic airway device which brings together features of the LMA~     ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal~     leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA~     ProSeal and the LMA Supreme in paralyzed anesthetized patients~   "
223970|NCT00626938|"~     Sarcoidosis is a multi-systemic disorder, meaning that it can involve any organ in the body~     and that its clinical presentation is highly variable. In 90% of all sarcoidosis cases the~     lungs are affected. It is difficult to give a concise definition of sarcoidosis due to the~     fact that its exact cause is still unknown. Consequently, diagnosing the disease is also~     rather difficult. Up till now, sarcoidosis is generally diagnosed by using general clinical~     methods to evaluate the status of the lung including a chest X-ray, lung biopsy and~     bronchoalveolar lavage (BAL). However, some of these methods are considered to be rather~     invasive and, even more important, non-conclusive. Therefore, the current study has been~     designed to evaluate the use of a new technique, called SELDI-TOF mass spectrophotometry, for~     the diagnosis of sarcoidosis. This technique enables the analysis of all enzymes present in~     the blood of sarcoidosis patients which may hopefully lead to creating a disease-specific~     protein-profile that may facilitate the recognition of sarcoidosis. Moreover, these results~     will be compared with other currently used laboratory parameters.~   "
223971|NCT00626925|"~     The purpose of this study is to evaluate the safety and efficacy of topiramate in reducing~     drinking and heavy drinking frequency in problem drinkers. We hypothesize that at a dosage of~     up to 200mg/day, topiramate will be well tolerated in this patient population and that,~     compared to placebo treatment, topiramate will result in a greater reduction in the frequency~     of both drinking days and heavy drinking days.~   "
223972|NCT00626912|"~     The PRET study aims at comparing two types of coils used in the endovascular treatment of~     intracranial aneurysms. The first type made of platinum has been used for more than 15 years.~     The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that~     expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET~     study is that the newer hydrocoil will be more effective and yet as safe as the older~     platinum coil.~   "
223973|NCT00626899|"~     Patients resuscitated from a cardiac arrest undergo therapeutic hypothermia as a treatment~     option. Measuring the cardiac output in these patients is sometimes important, but difficult,~     as these patients require an invasive device for measurement. Recently, a non-invasive device~     based on pulse-contour analysis of the arterial pulse was developed (the Vigileo).~     Hypothermia changes the pulse contour, so the performance of the Vigileo in patients with~     induced therapeutic hypothermia is not known. Therefore we conduct this observational study~     in which the cardiac output of the patients is measured with the traditional method and the~     Vigileo simultaneously.~   "
223974|NCT00626886|"~     The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and~     effective in reducing the amount of narcotic pain medication needed to control pain during~     the first 24 hours after herniorrhaphy.~   "
223975|NCT00626873|"~     RATIONALE: New diagnostic procedures, such as contrast-enhanced ultrasonography, may be an~     effective method of finding ovarian cancer.~      PURPOSE: This clinical trial is studying how well contrast-enhanced ultrasonography works in~     diagnosing early-stage ovarian cancer in patients with an adnexal mass undergoing surgery to~     remove the ovary.~   "
223976|NCT00626860|"~     This study aims to determine if the vacccine can be used safely in patients with advanced~     melanoma (cancer of the pigment cells) and whether the cells in this vaccine are capabale of~     producing immune responses against your own cancer.~   "
223977|NCT00626847|"~     Glaucoma is a group of diseases in which visual loss occurs because of damage to the optic~     nerve. Research has shown that certain genes may cause glaucoma in some cases. So far,~     research has only been able to find the genes responsible for glaucoma in a small percentage~     of people who have glaucoma. The purpose of this project is to study the genes in patients~     with and without glaucoma to find additional genes that may be responsible for causing~     glaucoma.~   "
223978|NCT00626834|"~     This is a Phase 1 safety/tolerably study to determine if there are clinically significant~     interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent~     with intravenous (IV) cocaine infusions.~   "
223979|NCT00626821|"~     The main purpose of the study is to document real life experience on SenSura with focus on~     skin condition and quality of life.~   "
223980|NCT00626808|"~     This is a retrospective cohort study of children included in a large medical insurance claims~     database.~   "
223981|NCT00626795|"~     An international, multi-centre, prospective three arm parallel-group, phase II proof of~     concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7~     days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2%~     cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an~     evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A~     total of 664 patients will be enrolled in a stepwise manner according to age groups starting~     with the oldest age group.~   "
223982|NCT00626782|"~     Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of~     trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing~     epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include~     late bleb leaks, hypotony and infection.~   "
223983|NCT00626769|"~     BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone~     metabolism with no clinically significant adverse effects in a cohort of osteopenic,~     postmenopausal women. However, there is still a knowledge gap regarding the long-term safety~     of genistein on the breast, the uterus, the thyroid gland and its efficacy in postmenopausal~     women.~      OBJECTIVE: To assess the safety profile of genistein on mammary and thyroid glands and~     endometrium and cardiovascular apparatus and its effects on bone metabolism after a 3-year~     therapy with pure, standardized genistein (54 mg/day).~   "
223984|NCT00626756|"~     Hypothesis: Fluid management guided by LiDCO doesn´t increase cumulative fluid balance and~     shorten organ dysfunction compared to fluid management based on CVP and clinical judgment.~   "
223985|NCT00626743|"~     To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and~     Amlodipine, phase I study in Hypertensive patient was designed.~   "
223986|NCT00626730|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose~     radiation therapy after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying radiation therapy to see how well it works in~     treating patients who have undergone surgery for newly diagnosed grade II or grade III~     meningioma.~   "
223987|NCT00626717|"~     Background: Corneal cross linking is a procedure that induces collagen cross linking of the~     corneal stroma due to release of reactive oxygen radicals upon activation of topically~     applied riboflavine A by UVA exposure. This procedure might be capable of reducing~     keratocouns progression.~      Purpose: Although there are no randomised controlled trials on the effectiveness of corneal~     cross linking for the treatment of keratoconus it gains more and more importance in the~     general clinical setting. Therefore, the investigators started such randomised, placebo~     controlled, double blinded, multicenter trial to find out if this treatment is as effective~     as it promises to be.~      Methods: Randomised, placebo controlled, double blinded, multicenter trial.~   "
223988|NCT00626704|"~     This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed~     to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with~     doxorubicin alone in subjects with previously untreated, locally advanced or metastatic,~     unresectable soft tissue sarcoma.~   "
223989|NCT00626691|"~     The goal of this study is to find out if the daily consumption of English walnuts (Juglans~     regia L.) for 6 wk, at a dose readily incorporated into the diet (0.75 or 1.50 oz), will have~     a positive effect on antioxidant capacity and nutrient status in a population of healthy~     adults, aged 50-70 y.~   "
223990|NCT00626678|"~     Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease~     with unknown etiology that affects mucosa and skin of patients with significant morbidity and~     mortality.~      The treatment back-bone is based on prednisolone administration. There are controversies on~     the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid~     sparing drugs. For others, they are disease modifying drugs.~      The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in~     new cases of pemphigus vulgaris treated with prednisolone.~   "
223991|NCT00626665|"~     In this double-blinded, placebo-controlled, fixed-dose, study patients will be randomly~     assigned to take placebo or 20 mg tadalafil thrice weekly for 6 weeks. After 6 weeks a wash~     out period of 2 week will be observed and then the two groups will be switched over to~     receive the other drug. We planned a priori to include 20 patients. The concomitant~     medication for treatment of rheumatic disease remained unchanged during the whole study.~     Patient will undergo clinical and lab evaluation for organ damage for kidney and lungs. ECHO~     heart will be done at base line to assess the PAH and LV function and repeated at the end of~     the study. Blood pressure will be recorded at each visit. A physician unaware of the~     treatment group will record skin score and appearance of new cutaneous ulcers. The primary~     outcome variables will be frequency and duration of Raynauds attacks, evolution of trophic~     digital lesions and change in flow mediated dilatation of the brachial artery. Flow mediated~     dilatation of the brachial artery will be done at baseline 6 and 12 weeks.~   "
223992|NCT00626652|"~     To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various~     cardiovascular parameters, and safety.~   "
223993|NCT00626639|"~     Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in~     postoperative Head and Neck setting~   "
223994|NCT00626626|"~     Allogeneic hematopoietic transplant is curative for many patients with hematological~     neoplasms but conditions to provide optimal engraftment and anti-tumor efficacy with minimal~     toxicity are still under way. Clofarabine is a newly licensed agent with dramatic~     anti-leukemic activity. Its incorporation into a regimen for pre-transplant conditioning of~     acute leukemia and lymphoma patients is logical, exploiting both the anti-tumor activities it~     is recognized to have and the immunosuppressive activity seen with drugs in its class.~   "
223995|NCT00626613|"~     To evaluate the relationship between Risperidone Treatment, Treatment Discontinuation Rate,~     and Quality of Life of patients with Alzheimer's Disease and BPSD.~   "
223996|NCT00626600|"~     Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with~     severe cancer pain.~   "
224085|NCT00625417|"~     RATIONALE: Diagnostic procedures, such as optical spectroscopy, may help learn the extent of~     disease and allow doctors to plan better treatment.~      PURPOSE: This phase I trial is studying optical spectroscopy to see how well it works in~     evaluating tumor margins in patients who have undergone surgery for breast cancer.~   "
223997|NCT00626587|"~     The diagnosis of peripheral pulmonary lesions(PPLs) remained a clinical challenge for~     physicians. Bronchoscope with sampling procedures was recognized as a useful method to obtain~     the correct diagnosis of PPLs. Conventional diagnostic procedures included transbronchial~     biopsy(TBB), bronchial washing(BW), or bronchial brushing, but the diagnostic yields were~     sometimes suboptimal. The diagnostic role of TBNA for PPLs remained to be determined, since~     many of the published studies were retrospective and had small sample size. This may explain~     the fact that TBNA was always underutilized for PPLs by bronchologists. With the popular~     application of EBUS-guided procedures in clinical setting, we performed EBUS-guided TBNA for~     PPLs. We want to determine whether EBUS-guided TBNA can improve the diagnostic rate of PPLs.~   "
223998|NCT00626574|"~     This is a prospective, randomized, double-blinded, placebo controlled pilot safety study that~     will enroll a total of twenty subjects. Subjects will be adults (30-75) who have sustained a~     SAH secondary to cerebral aneurysm rupture and who present with minimal neurological~     symptoms. All subjects will have a Hemoglobin less than or equal to 12 g/dL within 24 hours~     prior to study entry and undergo operative aneurismal clipping. Subjects will be randomized~     into two groups, ten subjects receiving the drug and ten subjects receiving the placebo. The~     subjects will receive three intravenous injections of study drug or placebo, once before~     undergoing operative aneurysmal clipping (study Day 1) and again for two additional days~     (study Day 2 and study Day 3).~      There are 3 phases to this trial:~      Screening Phase - patients will present with Subarachnoid hemorrhage (SAH) and prepped for~     surgery within 36 hours Treatment Phase - first pre-operative dose before surgery (Study Day~     1), post-operative (Study Days 2 and 3) Follow-up Phase- Study Day 4 through discharge, 6-7~     week follow-up Primary Objective: To determine the safety of administering intravenous doses~     of Procrit® once daily for three consecutive days to patients with aneurysmal SAH before and~     after vascular clipping by comparing the incidence of thrombotic events, hemoglobin and 6-7~     week mortality between the Procrit® and placebo groups. Secondary Objectives: To determine if~     administration of Procrit® prior to aneurysm clipping reduces the incidence of vasospasm~     following a SAH event treated by vascular clipping. To determine if Procrit® administration~     prior to aneurysm clipping in patients with Aneurysmal SAH will improve neurological~     assessment scores in the post-SAH/post-clipping time period. To determine the feasibility of~     organizing a larger, randomized study to explore the neuroprotective effect of Procrit® in~     patients with Aneurysmal SubArachnoid Hemorrhage (SAH) when Procrit® is administered prior to~     surgical clipping of the aneurysm.~      It is hypothesized that Procrit will provide a significant level of neuroprotection in the~     brain after an SAH event as a result of reduced cell death, as well as a reduced amount of~     vasospasm activity and delayed cerebral ischemia which can occur as a result of SAH. These~     factors may contribute to improved neurological functioning scores when compared to the~     placebo treated patients.~   "
223999|NCT00626561|"~     Objectives:~      Primary:~      To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell,~     large cell, and neuroendocrine cervical and uterine cancers, as measured by progression-free~     survival.~      Secondary:~        1. To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small~          cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by~          overall survival.~        2. To determine the response rates in patients with recurrent small cell, large cell, and~          neuroendocrine cervical and uterine cancers when treated with bevacizumab and~          paclitaxel.~        3. To characterize the quality of life (QoL) in patients with recurrent small cell, large~          cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and~          paclitaxel.~        4. To determine the nature and degree of toxicity in patients with advanced or recurrent~          small cell, large cell, or neuroendocrine cervical and uterine cancers when treated with~          bevacizumab and paclitaxel.~   "
224000|NCT00626548|"~     Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan)~     in hormone resistant prostate cancer (HRPC).~      This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can~     improve progression-free survival and overall survival against a background of existing~     prostate cancer treatments.~      ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread~     by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054~     (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA~     after surgical or medical castration but have no evidence of metastases.~      All patients participating in this clinical trial will receive existing prostate cancer~     treatments in addition to trial therapy.~      Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive~     placebo in addition to standard prostate cancer therapy. By participating in this trial there~     is a 50% chance that patients will receive an agent that may slow the progression of the~     tumour.~      No patients will be deprived of standard prostate cancer therapy.~   "
224001|NCT00626535|"~     This study compares 4 weeks of treatment with Esomeprazole 20 mg once daily to Placebo in the~     treatment of Upper Abdominal Pain in patients with Symptomatic Gastroesophageal Reflux~     Disease (sGERD)~   "
224002|NCT00626522|"~     The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for~     investigation in Phase III clinical trials~   "
224003|NCT00626509|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is~     not yet known whether sunitinib is more effective when given before or after surgery in~     treating kidney cancer.~      PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to~     compare how well it works when given before or after surgery in treating patients with~     metastatic kidney cancer.~   "
224004|NCT00626496|"~     Blood and lymph node cancers can begin in either the lymphatic tissues (as in the case of~     lymphoma) or in the bone marrow (as with leukemia and myeloma), and they all are involved~     with the uncontrolled growth of white blood cells. There are many subtypes of these cancers,~     e.g., chronic lymphocytic leukemia and non-Hodgkin lymphoma. Since there is evidence that~     these cancers cluster in families, this study aims to understand how genetics and~     environmental exposures contribute to the development of these cancers.~   "
224030|NCT00626158|"~     The purpose of this study is to find out what effects gemcitabine plus capecitabine has on~     patients with pancreatic or biliary cancer, and to determine the optimal dose that can be~     given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and~     capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These~     two drugs used together are considered an acceptable standard of care for pancreatic and~     biliary cancers. However, in this study the dose and dosing schedule will be changed, in the~     hopes that the drugs will have more effect with fewer side effects than when given in the~     standard way.~   "
224154|NCT00624468|"~     This study was intended to evaluate the efficacy, safety and tolerability of atacicept~     compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT~     in subjects with ON as CIS. The study was randomized. Study medication was administered via~     subcutaneous (under the skin) injections.~   "
224005|NCT00626483|"~     RATIONALE: Monoclonal antibodies, such as basiliximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Vaccines may help the body build an effective immune response to kill tumor~     cells. Giving these treatments together may kill more tumor cells. Granulocyte~     Macrophage-Colony Stimulating Factor (GM-CSF) is a powerful adjuvant capable of stimulating~     macrophage function, inducing proliferation and maturation of DCs, and is able to enhance~     T-lymphocyte stimulatory function. Intradermal administration of GM-CSF enhances the~     immunization efficacy at the site of administration~      PURPOSE: This clinical trial is studying how well basiliximab works in treating patients with~     newly diagnosed glioblastoma multiforme and temozolomide-caused lymphopenia who are~     undergoing targeted immunotherapy.~   "
224006|NCT00626470|"~     Fractures just below the hip often are treated with a so called Gliding Screw and Plate~     (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches~     to the DHS has become available which is claimed to give extra support to the fracture. In a~     prospective randomised study we wish to test the hypothesis that the TSP does not give any~     additional stability to the fracture treated with the DHS.~   "
224007|NCT00626457|"~     Losing weight has many health benefits for women such as reducing the risk of heart attacks,~     high blood pressure, diabetes, and cancer. However, women often struggle with maintaining the~     weight they have lost. This may be because they need to learn skills for maintaining weight,~     not just losing weight.~      When is the optimal time is to learn these maintenance skills? It may be better to lose~     weight first and then learn maintenance skills since people may feel good about the weight~     they have lost and be motivated to maintain. Alternatively, it may be better to learn~     maintenance skills first and then lose weight since they may experience how easy it is to use~     these maintenance skills and become confident they can maintain a weight loss in the future.~      Therefore, this study will examine whether learning these maintenance skills--before or after~     losing weight--helps women succeed at maintaining weight loss.~   "
224008|NCT00626444|"~     Eligible candidates will be adults with aggressive or very aggressive NHL (WHO classification~     diagnosis confirmed by histological tumor examination). Patients must have failed one or more~     prior NHL chemotherapy or antibody therapy with curative intent, and the disease must not~     have progressed within 60 days of last therapy. In addition, patients must not be candidates~     for potentially curative therapy, such as HSCT, or they must have refused these alternative~     therapies. Full inclusion/exclusion criteria are available. History and physical examination,~     and laboratory and imaging analyses will be done within 14 days prior to registration.~     Intravenous ascorbic acid will be given in a dose based on the plasma vitamin C level to~     reach a level in the range of 300 to 350 mg/dL. Vitamin C infusions will be given three times~     a week on a schedule that allows at least 24 hours between each infusion, for a total of ten~     weeks (30 infusions). If disease progression occurs before or at the ten week assessment,~     then we discontinue protocol, based on futility. Toxicity and adverse events also will result~     in immediate discontinuation (details available in full protocol). If there is lack of~     disease progression or disease improvement, proceed and reassess again at 10 week intervals,~     for a total of three 10 week intervals. Initial criteria are based upon the criteria from the~     International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson et al.,~     Report of an international workshop to standardize response criteria for non-Hodgkin's~     lymphoma, Journal of Clinical Oncology, 1999, Vol. 17, No4, 1244-1253); response for this~     study will utilize PET in accordance with revised criteria (Cheson et al. Revised response~     criteria for malignant lymphoma. J of Clin Oncol 2007; 25(5): 579-586). We select 20 patients~     as an appropriate study size to evaluate a true response rate to therapy, compared to just~     the observed response.~   "
224009|NCT00626431|"~     To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month~     depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A~     formulation will be deemed successful if the percentage of subjects with suppression of~     testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of~     the 2-sided 90% confidence interval), a protocol-specified criterion.~   "
224010|NCT00626418|"~     The purpose of this study is to assess the efficacy and tolerability of single doses of~     aplindore compared to placebo in RLS. Patients will be required to spend 5-8 nights in a~     sleep laboratory. This includes 1 adaptation night, 1 placebo night, and 3-6 drug treatment~     nights. Ascending doses of active drug will be administered on study nights 3 through 5 to~     determine the maximum well tolerated efficacious dose (defined as a decrease in Periodic Limb~     Movement Index (PLMI) of at least 50% from placebo baseline). If an efficacious dose cannot~     be identified the Investigator in consultation with the sponsor may decide to examine higher~     doses in up to 3 additional PSG nights in an attempt to identify a tolerable efficacious~     dose. This study will utilize up to 24 evaluable patients, each meeting International~     Classification of Sleep Disorders (ICSD-2) diagnostic criteria for primary RLS who are not~     currently taking any RLS medication including DAs ( and L-dopa) or who are able to~     discontinue their RLS medication at least 5 half-lives prior to the adaptation night.~   "
224011|NCT00626405|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, paclitaxel albumin-stabilized~     nanoparticle formulation, and carboplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as bevacizumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. It is not yet known whether bevacizumab is more effective~     when given together with temozolomide or paclitaxel albumin-stabilized nanoparticle~     formulation and carboplatin in killing malignant melanoma cells.~      PURPOSE: This randomized phase II trial is studying the side effects of giving temozolomide~     together with bevacizumab and to see how well it works compared with giving bevacizumab~     together with paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in~     treating patients with stage IV malignant melanoma that cannot be removed by surgery.~   "
224012|NCT00626392|"~     The primary purpose of this study was to assess the effect of aspirin (ASA) on niacin~     extended-release (NER)-induced flushing in subjects with dyslipidemia.~   "
224013|NCT00626379|"~     Heart disease is the leading cause of death in the United States and is responsible for 30%~     of all deaths in the United States. This study will examine how risk factors for heart~     disease in young and middle aged people affect people's health as they grow older.~   "
224014|NCT00626366|"~     The purpose of this study is to determine the distribution of nasal sprays and nasal drops.~     We hypothesize that nasal drops will reach the frontonasal region more often than nasal~     sprays.~   "
224015|NCT00626353|"~     Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with~     acute stroke. The trial seeks to evaluate:~        1. Can early home rehabilitation affect the degree of independence (motor capacity,~          activities of daily living and cognitive status), quality of life and the possibility of~          discharge to own home?~        2. Can home rehabilitation influence the length of admission at a rehabilitation centre in~          the municipality, readmission to hospital, the use of healthcare services and death?~        3. To what extend can home rehabilitation be implemented according to finances? Materials~          and methods: Patients at the age 18 years or more admitted to the stroke unit at the~          University Hospital of Gentofte. The patients were eligible when meeting the following~          criteria: symptoms of stroke, need of rehabilitation tree days after admission, living~          in own home in the Municipality of Gentofte, Lyngby-Taarbaek or Rudersdal and Modified~          Rankin Score between 0 and 3.~      The trial was conducted as a randomised controlled trial. The control group patients were~     rehabilitated according to normal procedure. The intervention group patients were~     rehabilitated according to normal procedure and were additionally rehabilitated at home~     during admission and four weeks after discharge.~   "
224016|NCT00626340|"~     The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in~     menopausal women with major depressive disorder and healthy subjects using nuclear magnetic~     resonance spectroscopy (MRS). Measurements will be compared in 1) menopausal healthy subjects~     before and after estrogen replacement, and after fourteen days of medroxyprogesterone~     administration; and 2) in depressed menopausal subjects before and after treatment of their~     depression with antidepressant alone, estrogen alone or antidepressant plus estrogen.~     Cortical GABA levels will be correlated with plasma GABA and neurosteroid levels.~     Neurosteroids to be measured include progesterone, allopregnanolone, pregnenolone, and~     pregnenolone sulfate.~   "
224017|NCT00626327|"~     Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy~     toddlers~   "
224018|NCT00626314|"~     The purpose of this study is to evaluate the safety and effectiveness of injecting myoblasts~     (grown from your own skeletal muscle), using a catheter device, directly into the damaged~     heart muscle for treatment of severe heart failure.~   "
224019|NCT00626301|"~     The purpose of this study is to evaluate the efficacy (clinical, immunological, virological~     outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance~     in Thai children after viral load suppression with double boosted protease inhibitors (PIs).~   "
224020|NCT00626288|"~     The purpose of this study is to determine whether Mesalazine is effective in the treatment of~     the abdominal discomfort or pain of Irritable Bowel Syndrome patients.~   "
224021|NCT00626275|"~     The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving pain~     associated with rheumatoid arthritis (RA) compared with placebo and naproxen (similar to~     Aleve®). A second objective is to see whether the effect of ADL5859 differs after a single~     dose compared with multiple doses.~   "
224022|NCT00626262|"~     The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered~     orally compared to intravenously on the maximum acid output in subjects with symptoms of~     Gastroesophageal reflux disease (GERD).~   "
224023|NCT00626249|"~     24 diabetics with mild & moderate renal disease and 12 diabetics without renal disease. One~     screening, one dosing & one follow-up visit with TechnosphereÂ® Inhalation Powder given at~     Visit 2 via MedToneÂ® Inhaler and PK testing at 26 designated time points~   "
224024|NCT00626236|"~     It is hypothesized that, when given at the lowest effective dose, the favorable side effect~     profile combined with it's lower propensity for weight gain would make SPN-810 a candidate~     for treatment of persistent serious conduct problems in pediatric subjects with ADHD.~   "
224025|NCT00626223|"~     A randomized prospective study was done to determine whether i.v. 5-methyltetrahydrofolate vs~     oral folate improved survival in ESRD patients. Homocysteine, CRP, Lp(a), albumin, folates,~     vitamin B6 and B12 were checked. The 5-MTHF treated group was associated with lowered C~     reactive protein and higher survival than the folate treated group.~   "
224026|NCT00626210|"~     Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration~     for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work~     sleep disorder. Each of these problems is characterized by difficulty sleeping at night and~     excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this~     sleepiness. The idea behind this treatment is that sleepiness that leads to napping during~     the day prevents a patient from being tired or sleepy enough to get good sleep at night. This~     study is designed to determine if the medication can reset participants' sleep/wake rhythm~     to a more normal rhythm.~   "
224027|NCT00626197|"~     This is a Phase III, randomized, double-blind, placebo-controlled, multicentre,~     parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC~     (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to~     SOC in patients with WHO or ISN Class III or IV lupus nephritis.~   "
224028|NCT00626184|"~     To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac~     Disease~   "
224029|NCT00626171|"~     The objective of this study is to determine the effect of cigarette smoking on inflammatory~     cell recruitment to the lungs after an allergen challenge, in non-smoking and currently~     smoking mild asthmatic subjects.~      When comparing non-smoking asthmatics to smoking asthmatics, do differential cell counts~     obtained from inflammatory cells in induced sputum after allergen challenge differ?~      Will differential cell counts show a decline in inflammatory cells in the induced sputum of~     asthmatics who have refrained from smoking for eight weeks?~      This study is a randomized, case-controlled study. The first part of the study requires~     smoking and non-smoking subjects who will attend 2 study periods of 3 consecutive days~     (triad). In each triad, they will be challenged with allergen or diluent by inhalation, in a~     random order, and each triad is separated by a washout period. In the second part of the~     study, current smokers will be invited to undergo another allergen challenge 8 weeks of~     smoking cessation.~   "
224058|NCT00625794|"~     The objective of this pilot study is to determine the feasibility and utility of using the~     nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.~   "
243203|NCT00371007|"~     A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2~     diabetes mellitus who have inadequate glycemic control on diet/exercise therapy~   "
224031|NCT00626145|"~     The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI)~     is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed~     the short term outcome of bone marrow stem cell transplantation for MI patients, but rare~     report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV~     functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in~     patients with ST-elevation myocardial infarction.~   "
224032|NCT00626132|"~     The purpose of this study is to demonstrate that eucommia, an herb used in China for making~     tea, is safe and effective for lowering blood pressure in humans with high blood pressure.~   "
224033|NCT00626119|"~     RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an~     effective method of finding microcalcifications and lesions in the breast.~      PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in~     finding breast microcalcifications and lesions in women.~   "
224034|NCT00626106|"~     This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include~     postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast~     cancer, who have disease progression during or within 12 months after completing prior~     adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic~     disease.~   "
224035|NCT00626093|"~     The purpose of this prospective study is to evaluate the effect of cardiac resynchronization~     therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization~     therapy defibrillators (CRT-D) patients. The hypothesis of the study is that defibrillation~     threshold (DFT) will decrease with 6 months of cardiac resynchronization therapy (CRT).~   "
224036|NCT00626080|"~     The aim of this study is to test the hypothesis that subcutaneous administration of insulin~     detemir, as compared to insulin NPH, leads to a more pronounced effect on cerebral glucose~     metabolism and/or cerebral blood flow in brain regions associated with appetite regulation,~     to account for the reported difference in weight.~   "
224037|NCT00626067|"~     The primary objective of this study is to determine the opinions of patients who are given~     the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma~     drops.~   "
224038|NCT00626054|"~     The purpose of this study is to compare the effectiveness (quality of bowel cleansing) and~     ease of use (patient satisfaction) of two methods of administration of a precolonoscopy PEG~     solution in hospitalized patients.~   "
224039|NCT00626041|"~     High blood pressure, elevated blood glucose and high cholesterol are related to the increased~     risk of stroke and heart disease. Many studies have shown that this risk can be significantly~     reduced by lowering blood pressure, blood glucose and cholesterol levels.~      Through a collaborative effort between Calgary Safeway pharmacists and Calgary Health Region~     family physician PCN's, U-CHAMP will deliver a program to assist in the identification and~     management of people with elevated blood pressure, blood glucose and cholesterol and through~     this effort, reduce the risk of heart disease and stroke in the urban Calgary population aged~     18-85 years.~   "
224040|NCT00626028|"~     A minimum of 100 patients will be enrolled in the study to demonstrate which diagnostic~     treatment (oxygen or nitric oxide) is most capable of identifying patients with a reactive~     pulmonary vascular bed. Each patient will be given all three treatment regimen, nitric oxide,~     oxygen, and the comparison treatment (nitric oxide plus oxygen), with a wash out period of 10~     minutes between each dose. Patients will be randomized at the time of enrollment to determine~     which comparison treatment they will receive.~   "
224041|NCT00626015|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Vaccines may help the body~     build an effective immune response to kill tumor cells. Monoclonal antibodies, such as~     basiliximab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. It is not yet known whether giving chemotherapy, radiation therapy, and~     vaccine therapy together with basiliximab is a more effective treatment for glioblastoma~     multiforme than chemotherapy, radiation therapy, and vaccine therapy alone.~      PURPOSE: This randomized phase I trial is studying the side effects and best way to give~     chemotherapy and radiation therapy followed by vaccine therapy with basiliximab in treating~     patients with glioblastoma multiforme that has been removed by surgery.~   "
224042|NCT00626002|"~     The purpose of this study is to evaluate long term safety, efficacy and tolerability of~     ABT-874 in adults with moderate to severe psoriasis.~   "
224043|NCT00625989|"~     Summary:~      A picture is emerging of dendritic cells migrating through the blood to the airways following~     allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present~     novel findings, both do not provide a comprehensive view of sputum DCs following allergen~     challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the~     induced sputum of atopic asthmatics following inhalation of allergen.~      Hypothesis:~      Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the~     airway lumen in atopic asthmatics during the timeframe of the late asthmatic response.~      Objective:~      The objective of this study is to examine the kinetics of dendritic cells in induced sputum~     following allergen challenge in atopic asthmatic subjects.~   "
224059|NCT00625781|"~     The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women~     with impaired glucose tolerance (75-g OGTT with a fasting P-gluc <7.0 mmol/l and 2 h P-gluc~     >10.0 and <12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal~     morbidity. There will be a focus on treatment according to specific goals and separate~     follow-up regimes for the children and women post partum.~   "
224060|NCT00625768|"~     To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of~     AS1409 in single and repeated doses.~   "
224061|NCT00625755|"~     This study will look how using taken from your tumors and mixed with special immune~     stimulating cells from another person's blood in given back to you in a series fusion cell~     injections, will effect your body. The primary goal of the study is to see if giving the~     experimental fusion cell injections is safe. We will also be looking to see what effect the~     experimental treatment as on your immune system and whether it has an effect on your cancer.~   "
224044|NCT00625976|"~     Background:~      Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment~     guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement~     at the level of pain and coping with pain. Only little improvement in functional restoration~     was found. Research in other pain populations such al neck- and back-pain patients has shown~     that pain related fear contributes to the development of functional disability. GEXP in vivo~     which aims on systematically reducing fear of movement, shows promising results in CRPS-I~     patients (de Jong et al., 2005).~      Objective:~      The objective of the proposed project is to compare the effectivity of GEXP in vivo with that~     of standardized physiotherapy in CRPS-I patients with pain related fear.~      Design:~      The study concerns a single blinded, single center, randomized clinical trial. The treatment~     will be preceded by two pre-measures. After treatment there will be one post-measurement and~     3, 6 and 12 month follow-up measurements.~      Population:~      The study population will consist of chronic CRPS-I patients between 18 and 65, with pain~     related fear (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32).~      Intervention:~      The two interventions that will be compared are GEXP in vivo (de Jong et al., 2005) and~     standardized physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo en~     Goris (1999). The GEXP in vivo comprises 17 sessions of one hour, the physiotherapy treatment~     of 34 sessions of 30 minutes. Both treatments will be given over a period of 17 weeks.~   "
224045|NCT00625963|"~     Current standard of the diagnosis and monitoring of PHNT requiring combination of invasive~     and non-invasive tests. The goal of the study is to correlate data from CT scans,~     echocardiograms, right heart catheterization, PFTs, sleep studies, and perfusion scans. The~     ultimate goal is to determine patterns of the PAH disease processes.~   "
224046|NCT00625950|"~     Dopamine agonists, such as quinagolide, are able to act on the VEGFR-2 blocking antibodies,~     diminishing Vascular Endothelial Growth Factor effect on angiogenesis in human endometriotic~     lesions.~   "
224047|NCT00625937|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     more than one drug (combination chemotherapy) together with radiation therapy may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with~     radiation therapy and low-dose cisplatin works in treating patients with stage III or stage~     IV head and neck cancer.~   "
224048|NCT00625924|"~     The goal of the study is measure breast sensations after breast surgery. The results of this~     study will help surgeons better understand breast sensations and may improve the way surgery~     is done.~   "
224049|NCT00625911|"~     Thoracotomy for lung tumor or for minimally invasive direct coronary artery bypass (MIDCAB)~     surgery, may be associated with debilitating pain. Ketamine was shown to enhance opioid~     antinociception and prevent opioid resistance. We hypothesize that ketamine given with~     morphine would lower morphine consumption and narcotic related side effects after thoracotomy~     and provide superior analgesia to morphine given alone.~   "
224050|NCT00625898|"~     The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in~     patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.~   "
224051|NCT00625885|"~     The purpose of this study is to determine the effects of modifiable risk factors on~     patient-reported quality of life, physical activity levels, and risk of early osteoarthritis~     following revision anterior cruciate ligament (ACL) reconstruction.~      The investigators hypothesize that modifiable variables exist at the time of revision ACL~     reconstruction (e.g., cause of failure, current graft source and type, surgical exposure, and~     femoral and tibial tunnel position) which will be predictors of patient-reported outcomes.~   "
224052|NCT00625872|"~     The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or~     0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive~     performance.~   "
224053|NCT00625859|"~     The purpose of this research study is to look at concentrations of GSK189075, WELLBUTRIN SR~     and active metabolic products in blood samples when doses of both drugs are taken by mouth.~     Doses are either taken alone or together. The results will help to determine if doses of~     GSK189075 and WELLBUTRIN SR can be safely taken together.~   "
224054|NCT00625846|"~     This phase II trial studies the side effects and how well pazopanib hydrochloride works in~     treating patients with advanced thyroid cancer. Pazopanib hydrochloride may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood~     flow to the tumor.~   "
224055|NCT00625833|"~     This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving~     chronic peripheral pain suffered by patients with diabetes. Some evidence for the~     effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed~     trials.~   "
224056|NCT00625820|"~     Patients with chronic kidney disease (CKD) and albuminuria are at increased risk of~     developing cardiovascular disease (CVD) which is often associated with hypertension, left~     ventricular hypertrophy, endothelial dysfunction and increased generation of reactive oxygen~     species (ROS). These patients also manifest a decrease in nitric oxide (NO) availability~     which is thought to play an important role in their progressive vascular disease.~      Tetrahydrobiopterin (BH4), an essential cofactor for endothelial nitric oxide synthase(eNOS),~     an important regulator of NO and that is a key mediator of endothelial dysfunction. Changes~     in NO availability are believed to contribute to endothelial dysfunction seen in CKD and~     common CVD states. 6R-tetrahydrobiopterin (6R-BH4 or sapropterin dihydrochloride) is an~     investigational oral drug that is being evaluated to determine whether it will restore NO~     availability, leading to beneficial effects on vascular function and ultimately positive~     clinical outcomes in patients with CKD. The primary endpoint in this study is the level of~     albuminuria, an easily measured marker that has served as a predictor of kidney disease~     progression. If 6R-BH4 reduces albuminuria in patients with kidney disease, it may have~     implications to slow the disease progression as well as decreased risk of CVD.~   "
224057|NCT00625807|"~     Currently there are 2 popular stress reduction courses that are widely used in the US.~     Although they use somewhat similar techniques, it is currently unknown whether or not they~     work the same way, or if they are similarly effective at reducing stress. The study will~     directly compare these 2 courses. Participants will undergo approximately 4-5 hours of~     testing before and after each 8-week course.~   "
224062|NCT00625742|"~     The primary aim of this proposal is to present a novel, multimodal treatment strategy for~     increasing lean body mass in individuals with cancer who experience cachexia between baseline~     and day 29 (+/- 3 days). The strategy includes graded resistance training and aerobic~     exercise, targeted nutrient supplementation and pharmacologic intervention (melatonin).~      We postulate that this strategy, together with the simultaneous management of symptoms that~     decrease appetite (e.g. depression, pain, and nausea), will also accomplish our secondary~     objectives of improving clinical outcomes such as strength and function between baseline and~     day 29 (+/- 3 days).~   "
224063|NCT00625729|"~     RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating~     natural killer cells with aldesleukin in the laboratory may help the natural killer cells~     kill more cancer cells when they are put back in the body. Giving monoclonal antibodies, such~     as rituximab, and chemotherapy drugs, such as fludarabine and cyclophosphamide, before a~     donor natural killer cell infusion helps stop the growth of cancer cells. It also helps stop~     the patient's immune system from rejecting the donor's stem cells.~      PURPOSE: This phase I/II trial is studying how well giving rituximab and chemotherapy~     followed by a donor natural killer cell infusion that has been treated in the laboratory with~     aldesleukin followed by aldesleukin works in treating patients with non-Hodgkin lymphoma or~     chronic lymphocytic leukemia.~   "
224064|NCT00625703|"~     To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of~     linezolid among children with cystic fibrosis and establish a dose regimen that will be safe~     and effective.~   "
224065|NCT00625690|"~     RATIONALE: Screening tests, such as CT scanning, may help doctors find cancer cells early and~     plan better treatment for lung cancer.~      PURPOSE: This clinical trial is studying how well a lung cancer screening program using CT~     scanning works in current and former smokers.~   "
224066|NCT00625677|"~     The purpose of this study is:~      To assess whether there are differences in antibody persistence eight months post primary~     (pre−booster) or in responses to the booster with regard to the Meningococcal C Conjugate~     (MCC) vaccine given in infancy.~      To examine levels of diphtheria and tetanus antibody pre− and post−booster, with regard to~     the carrier proteins contained in the conjugate vaccines.~   "
224067|NCT00625664|"~     This is a randomized, open-label, multi-center study comparing the efficacy and safety of~     XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally~     advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare~     overall survival. Secondary objectives include comparisons of progression free survival,~     objective response rate, time to definitive deterioration of performance status, duration of~     response, time to definitive weight loss, and assessments of overall safety, and~     pharmacokinetics. Patients are treated until disease progression, death, or unacceptable~     toxicity and are followed-up until death or the end of the study whichever comes first.~   "
224068|NCT00625651|"~     This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed~     to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab~     compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic~     colorectal cancer (CRC).~      The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured~     by progression-free survival, objective response rate, time to response, duration of~     response, and overall survival. This study is also designed to evaluate the safety and~     tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG~     655 antibody formation and the pharmacokinetics of AMG 655.~   "
224069|NCT00625638|"~     The goal of this research study is to learn if using an Interactive Voice Response (IVR)~     system can bring about better and more timely symptom control for patients with advanced~     cancer.~      Primary Objectives:~        -  To determine whether the Interactive Voice Response (IVR) system, supplemented by~          Nursing Telephone Intervention (NTI), results in better symptom management and quality~          of life than standard care for individuals with advanced cancer as evidenced by reduced~          scores on symptom measures.~        -  To determine whether the IVR system, supplemented by NTI, results in reduced caregiver~          burden, increased caregiver satisfaction with care, and improved coping strategies.~        -  To determine the feasibility of using an IVR system, supplemented by NTI, for symptom~          assessment in individuals with advanced cancer and their caregivers by conducting a~          process evaluation of the system. Variables to be evaluated include rates of participant~          recruitment and retention, frequency of use of the system, acceptability of the system~          to participants, and barriers to participation. Researchers' goal is to identify and~          improve aspects that affect external validity (recruitment rate, cohort maintenance),~          internal validity (implementation, contamination), participant acceptability and~          satisfaction, and reaction to study procedures. The findings from this evaluation will~          also allow researchers to evaluate delivery of interventions in future studies.~   "
224070|NCT00625625|"~     RATIONALE: Diagnostic procedures, such as lymph node mapping during surgery and sentinel~     lymph node biopsy, may help doctors find micrometastases and predict cancer recurrence.~      PURPOSE: This phase II trial is studying how well lymph node mapping during surgery together~     with sentinel lymph node analysis and blood testing work in detecting and predicting early~     micrometastases in patients with colorectal cancer.~   "
224071|NCT00625612|"~     The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of~     Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or~     equal to 75% but less than or equal to 110% predicted.~   "
224084|NCT00625430|"~     The primary objective of this study is to determine the safety and tolerability of a~     gene-directed enzyme prodrug therapy for prostate cancer. FP253 contains an ovine~     atadenovirus that expresses the E. coli enzyme purine nucleoside phosphorylase (PNP) under~     the control of a prostate-directed promoter. PNP converts systemically administered~     fludarabine (the prodrug) into 2-fluoroadenine (the active agent) at the site where FP253 has~     been administered (the prostate). This localized conversion is expected to provide~     organ-targeted chemotherapy that should reduce the systemic side effects associated with~     classical chemotherapy and also reduce the risk of debilitating damage to tissues surrounding~     the prostate.~   "
224169|NCT00624273|"~     This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in~     systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers~     and their count and analyze the effect of sildenafil on angiography.~   "
224072|NCT00625599|"~     As the population's life expectancy increases, fractures among the elderly in El Salvador are~     also increasing. There is currently limited data specific to the incidence and cause of~     fractures in the elderly within developing countries, such as El Salvador. The problem of~     inadequate knowledge pertaining to bone health and osteoporosis among the elderly is~     contributing to this aging population's health issues. The purpose of this study is to~     investigate the incidence, prevalence, and risk factors effecting elderly patients admitted~     for fractures at the Hospital Zacamil in San Salvador, El Salvador. The study will also~     assess the current knowledge in two distinct populations on bone health and osteoporosis. The~     first population will be the patients over the age of 45 that present to Hospital Zacamil~     with acute fractures and are consulted by the department of orthopedics. The second~     population will consist of students at the Evangelical University over the age of 18 in~     non-medial track studies. All individuals will have to accept the invitation to participate~     in the study. In addition, educational materials will be developed on the prevention of~     fractures for medical professionals and for the elderly in El Salvador. The study objectives~     will determine incidence and prevalence of elderly fractures of patients over the age of 45~     at Hospital Zacamil. Secondly, the study will look at demographic information, prevalent~     causes of fractures, treatment of the fractures, morbidity and mortality, and any~     complications that may arise in the fracture patients prior to their discharge from the~     hospital. Thirdly, the study will seek out the current level of knowledge on bone health,~     osteoporosis, and fracture prevention in the young, educated Salvadorians and patients over~     the age of 45 at Hospital Zacamil. Fourthly, the study will address the benefits of the~     information gained by use of educational materials with the patients and doctors of El~     Salvador.~      Hypothesis One:~      Fractures of the elderly at Hospital Zacamil are significantly associated with occurring at~     the hip, wrist, and vertebra in comparison to other fracture locations.~   "
224073|NCT00625586|"~     RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving RAV12 together with gemcitabine may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying the side effects and best dose of monoclonal~     antibody RAV12 when given together with gemcitabine in treating patients with metastatic~     pancreatic cancer.~   "
224074|NCT00625573|"~     This is an open-label, phase II study to evaluate the efficacy and safety of Abraxane in~     combination with Capecitabine in patients with metastatic colorectal cancer in the second or~     third line~   "
224075|NCT00625560|"~     This is a randomized, open-labelled, prospective 96-week study comparing the antiviral~     efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining~     lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine~     monotherapy.~   "
224076|NCT00625547|"~     The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with~     levodopa in the treatment of patients with RLS.~   "
224077|NCT00625534|"~     Background: Large acceptance of mesh reinforcement techniques in groin hernia repair lowered~     recurrence rates for all techniques. Recurrence rate alone is not the main quality criterion~     for hernia repair anymore. Chronic significant post operative pain is a common, clinically~     relevant, poorly understood and poorly studied entity which is 3 to 5 times more common than~     hernia recurrence. As a subgroup to chronic significant post operative pain or as a separate~     entity, sexual dysfunction due to ejaculatory and genital pain after inguinal hernia repair~     may happen in approximately 2.5% of patients. Patient's preoperative psychological profile as~     well as pain exposure history is showed to be important in the development of chronic~     significant post operative pain. The objective of this study is to analyse chronic~     significant post operative pain and the functional outcome status of patients after~     laparoscopic repair compared to open repair.~      Methods: A randomized controlled non-blinded clinical trial is designed to compare open~     inguinal hernia mesh repair with laparoscopic totally extraperitoneal repair on chronic~     significant post operative pain, pain related sexual function disorders, complications,~     health related quality of life outcomes, recurrence rates, and cost. Volunteers will be~     recruited in Geneva University Hospital, department of surgery, visceral surgery unit.~     Eligibility criteria is male patient aged over 21 years, with reducible inguinal unilateral~     or bilateral primary hernia who are candidates for elective surgery and medically fit for~     general anesthesia.130 patients will be enrolled for each group to achieve an α-Level of 0.05~     and a power of 80%. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post~     operative months by questionnaires and by clinical exam by independent expert. An overall~     cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and~     estimated to end in may 2009.~   "
224078|NCT00625521|"~     Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical~     forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease~     confined to the skin.~      The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream~     0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.~   "
224079|NCT00625495|"~     The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered~     orally compared to intravenously on the maximum acid output in subjects with symptoms of~     Gastroesophageal reflux disease (GERD).~   "
224080|NCT00625482|"~     Our group has consistently found that the major interventions to reduce morbidity and~     mortality in low-income countries have sex-differential effects. These interventions include~     BCG vaccine, oral polio vaccination (OPV), and vitamin A supplementation (VAS).~      Low-birth-weight (LBW) children constitute the largest high-risk group in low-income~     countries. According to current policy, they receive OPV at birth. Current evidence suggests~     that a policy of providing BCG with OPV for girls and VAS instead of OPV for boys at birth~     may improve survival in LBW neonates. This will be tested in a large randomized trial.~      We experienced an unexpected cluster of deaths among boys in the VAS arm, which could be due~     to chance, but we decided to stop randomizing boys to OPV or VAS. Very recent evidence has~     suggested that low-birth-weight boys may benefit from BCG at birth as well. Hence, we have~     obtained ethical permission to continue the trial with randomization of boys to OPV or OPV~     plus BCG.~   "
224081|NCT00625469|"~     Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is~     a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently~     there is no significant data to support the use of pulmonary vasodilators for PAH in the~     setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH~     either at rest or during exercise. The study hypothesis is that bosentan may improve~     morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or~     exercise PAH.~   "
224082|NCT00625456|"~     This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic~     solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small~     cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck.~     These tumor types were selected because evidence of biological activity was observed in these~     tumor types in a Phase I study of JX-594 (Pexa-Vec) administered by intratumoral injection in~     patients with metastatic disease to the liver. Patients will receive treatment at one of five~     dose levels in a sequential dose-escalating design.~   "
224083|NCT00625443|"~     The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag)~     administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were~     enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).~   "
224086|NCT00625404|"~     This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative~     women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to~     investigate the safety and effectiveness of a once-daily Truvada® pill (compared with~     placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through~     sexual intercourse.~      The study population included HIV-antibody-negative women between the ages of 18-35 who were~     at risk of HIV acquisition through sexual intercourse. Each participant was randomized to~     take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of~     emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical~     placebo.~      After enrollment, each participant was followed every four weeks. All participants were~     followed for an additional eight weeks after study drug was stopped. Incidence rates of HIV~     infection were compared between the two groups (active drug and placebo) using the~     intent-to-treat principle.~   "
224087|NCT00625391|"~     Osteoporosis is a major health problem in postmenopausal women. Our long-term goal is to~     develop a new alternative treatment that include a dietary supplement (green tea extract) and~     a mind-body exercise (Tai Chi) for lessening bone loss in postmenopausal women with low bone~     mass. A combination of dietary supplement and moderate intensity exercise now becomes a new~     alternative treatment in reducing bone loss in postmenopausal women with low bone mass, due~     to the possible stronger effects of the combination than individual treatments. Objective: To~     test a CAM intervention including green tea polyphenol (GTP) and Tai Chi (TC) exercise for~     feasibility, and to quantitatively assess their individual and conjugate effects on~     postmenopausal women with osteopenia. Hypotheses: (1) 24 weeks of GTP supplement, TC~     exercise, and their combination will benefit bone remodeling as measured by bone biomarkers~     and muscle strength/physical function in postmenopausal women with osteopenia compared to~     those receiving placebo only, and (2) the changes in bone biomarkers associated with bone~     remodeling will be correlated with the changes in oxidative stress.~   "
224088|NCT00625378|"~     This study will enable patients receiving sorafenib (Nexavar) in the completed Bayer/Onyx~     sponsored clinical trials to continue treatment. During the entire course of the study,~     numerous patients will be treated with sorafenib. Involvement in this study will be depending~     on whether the patient benefits from the treatment or not, based on the physician's judgment~     and the results of particular additional examinations. Overall, participation in this study~     will help to evaluate the safety and efficacy of treatment with sorafenib.~   "
224089|NCT00625365|"~     The purpose of this registry study is to gather safety information on the current clinical~     use of and the safety of DEFINITY®~   "
224090|NCT00625352|"~     Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the~     common clinical practices oncologist are now facing. So, we need to seek adequate regimens~     for them. Gemcitabine is well known to be one of active third generation agents in terms of~     both efficacy and tolerability. Gemcitabine alone have been recommended as first line~     treatment for elderly NSCLC patients, especially in the aspect of tolerability. However,~     gemcitabine alone is suggested to be suboptimal to control their disease. Therefore, we plan~     to make an optimal regimen containing gemcitabine for the elderly patients.~   "
224091|NCT00625339|"~     This is a randomized, open-labelled, prospective 96-week study comparing the antiviral~     efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining~     lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.~   "
224092|NCT00625326|"~     Low doses of topically administered vitamin D analogs have been shown to have an~     anti-psoriatic effect without the risk of hypercalcemia. Calcipotriol, the most thoroughly~     studied of the vitamin D analogs, was first approved in Europe in the early 1990s. It has~     been shown to be comparable or slightly more effective than class II corticosteroid~     ointments. However, patients had reduced levels of parathyroid hormone; mean serum and urine~     calcium were increased during treatment and hypercalciuria was observed. These effects were~     reversible with discontinuation of therapy. Thus, while calcipotriol ointment was shown to be~     effective, the potential for alterations in calcium homeostasis have limited its use to 100 g~     of ointment per week (0.5 mg calcipotriol/week). Work has continued on the creation of new~     vitamin D analogs, such as COL-121, with the intent of eliminating the adverse effects of~     hypercalcemia and hypercalciuria with a compound that is more stable and more easily~     administered.~   "
224093|NCT00625313|"~     The purpose of this study is to assess the safety and efficacy of the HMY Model YA-60BB~     Intraocular Lens (IOL) when implanted in the posterior chamber of the human eye for the~     optical correction of aphakia following cataract extraction.~   "
224094|NCT00625300|"~     The purpose of this study is to test the effects of deep rTMS using the novel H-coil on the~     motor, affective and cognitive deficits in patients with Parkinson's disease (PD) and to~     establish its safety in this population.~   "
224095|NCT00625274|"~     This study looks at controlling intragastric pH following administration of esomeprazole 40~     mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking~     either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory~     drugs (NSAIDs).~   "
224096|NCT00625261|"~     The purpose of the study is to examine the effectiveness of a highly-structured parent-based~     language intervention group program for two-year-old children with language delay.~   "
224097|NCT00625248|"~     This study will evaluate bleeding risk and differences in outcomes in patients receiving and~     not receiving anticoagulant or antiplatelet therapy~   "
224098|NCT00625235|"~     An investigation into long term weight maintenance using a high protein or high carbohydrate~     diet, after a large and rapid weight loss.~   "
224099|NCT00625222|"~     The aim of the study is to establish tDCS as a prognostic tool to predict VNS therapy outcome~     among patients with pharmacoresistant epilepsy.~   "
224100|NCT00625209|"~     This study aims at comparing the efficacy and safety of recombinant human activated protein C~     to that of low dose of corticosteroids and at investigating the interaction between these~     drugs in the management of septic shock~   "
224110|NCT00625066|"~     RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in~     the laboratory and gathering information about health and lifestyle from participants may~     help doctors learn more about cancer risk factors.~      PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors~     for developing colorectal adenomas or polyps in participants undergoing colonoscopy.~   "
224101|NCT00625196|"~     A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is~     being developed for once daily administration for the maintenance treatment of asthma and~     COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and~     compared with GW642444M and GW685698X administered separately in order to determine whether~     co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics~     of either compound in healthy Japanese subjects.~   "
224102|NCT00625183|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together With~     selenomethionine and radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well selenomethionine works when given together~     with capecitabine, oxaliplatin, and radiation therapy in treating patients undergoing surgery~     for newly diagnosed stage II or stage III rectal cancer.~   "
224103|NCT00625170|"~     We hypothesized that short-term treatment with AP drugs induces insulin resistance through a~     mechanistic route that is independent of weight gain and that atypical drugs exert stronger~     effects than typical compounds in this respect. We therefore treated healthy non-obese men~     with olanzapine (atypical AP) or haloperidol (typical AP) for 8 days, and studied the impact~     of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp,~     isotope dilution technology and indirect calorimetry.~   "
224104|NCT00625157|"~     Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical~     forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease~     confined to the skin.~      The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream~     0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.~   "
224105|NCT00625131|"~     This study seeks to evaluate the relationship between PTSD, abstinence, and factors~     associated with relapse in the context of a randomized, clinical smoking cessation trial.~   "
224106|NCT00625118|"~     This will be an observational study where parents/ guardians of children in receipt of their~     preschool booster will be approached for their child(ren) to take part. Following written~     informed consent the Vaccine Research Nurse will explain the purpose of the study and what~     would be involved. Participation will involve completion of a health diary for the week~     following vaccination to document how their child has been both in terms of local reactions~     and systemic symptoms as well as any visits to a doctor (GP or hospital). The nurse will~     telephone the family at 48−72 hours following vaccination to see how the child has been.~     Information about the vaccine given in the current campaign and vaccines administered in the~     infant schedule including date of administration, product and batch number will be recorded~     where available.~      Should any large local reactions be reported the nurse may visit the child to take a~     photograph to document and illustrate these - photographs will be taken without the child's~     face visible.~      Subjects will be recruited in two centres - Hertfordshire and Gloucestershire. Recruitment~     will start as soon as the necessary approvals are in place. Monthly reports of observed data~     will be submitted to the MHRA though the formal analysis will not be conducted until the end~     of the study.~      Recruitment figures and the incidence of ESLs will be reviewed on a six−monthly basis.~      At this point it is difficult to predict parental attitude to taking part, though from~     experience with recruitment in previous studies it is hoped this will be positive, so~     affording a large number of participants.~   "
224107|NCT00625105|"~     This study will test the effectiveness of Heart Rate Variability (HRV) Biofeedback as a~     therapeutic tool in the reduction of everyday memory problems routinely experienced by combat~     veterans with Posttraumatic Stress Disorder (PTSD). The study is innovative in three ways:~     (1) through its investigation of the clinical use of a novel PTSD treatment technology, (2)~     by focusing on the understudied aspect of the daily functioning of PTSD veterans, and, (3) by~     investigating a heretofore untested application of biofeedback for PTSD induced deficits in~     attention (ATTN) and immediate memory (IM). Though HRV Biofeedback has proven successful for~     several applications in the general population, the idea that deficits in ATTN/IM in combat~     veterans with PTSD can be remedied by normalization of HRV has not yet been tested~     empirically. HRV is functionally incorporated into attentional processes, essentially~     operating as an index of autonomic flexibility and the ability to self-regulate in response~     to stimulation from the environment. Low HRV occurs in patients with PTSD, General Anxiety~     Disorder, and Coronary Artery Disease, and is correlated with negative affect and hostility.~     HRV Biofeedback training has been shown to be effective in increasing HRV in these groups of~     patients, as well as improving psychological well-being and physiological function in~     patients with Depression, Fibromyalgia, and Cardiovascular Disease. Therefore, the~     interrelationship between HRV and ATTN/IM problems in PTSD+ Combat veterans warrants further~     investigation. If HRV Biofeedback significantly improves ATTN/IM in these subjects, then it~     can be offered to VA clinicians treating combat PTSD as an effective new treatment tool.~   "
224108|NCT00625092|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to~     several degrees above normal body temperature. Peritoneal infusion of heated and nonheated~     chemotherapy drugs after surgery may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic~     intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in~     treating patients with peritoneal cancer.~   "
224109|NCT00625079|"~     Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is~     a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently~     there is no significant data to support the use of pulmonary vasodilators for PAH in the~     setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH~     either at rest or during exercise. The study hypothesis is that sildenafil may improve~     morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or~     exercise PAH.~   "
224390|NCT00621361|"~     This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in~     combination with etoposide and cisplatin (EP) as first line treatment for lung cancer~     patients with extensive stage or metastatic disease for whom EP would be a standard therapy.~   "
224111|NCT00625053|"~     Background: Midline incisional hernia is reported from 0,5 to 11% after abdominal operations.~     Primary repair without mesh reinforcement is almost abandoned because of high recurrence~     rates (24 to 46%). Use of prosthetic mesh in incisional hernia repair lowered the recurrence~     rates under 10%. Recurrence rate alone is not the main quality criterion for incisional~     hernia repair anymore. Large series and meta-analyses confirmed the value of laparoscopic~     repair as at least equal if not better compared with open repair. Discomfort, pain,~     diminished quality of life and body image alteration influences functional well being. No~     baseline information exists in any of these fields treating pre- or post-operative phases in~     patients with incisional hernia. Respiratory functions and medico-economic evaluation are~     other rarely investigated fields that we consider in our trial. The objective of this study~     is to analyse the functional outcome status of patients after laparoscopic incisional hernia~     repair compared to open repair.~      Methods: A randomized controlled non-blinded clinical trial is designed to compare~     laparoscopic incisional hernia mesh repair with open repair on post operative pain, health~     related quality of life outcomes, body image and cosmetic measurements, respiratory~     functions, recurrence rates, and cost. Volunteers will be recruited in Geneva University~     Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient~     aged over 18 years, with reducible incisional hernia who are candidates for elective surgery~     and medically fit for general anesthesia.30 patients will be enrolled for each group.~     Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by~     questionnaires and by clinical exam by independent expert. An overall cost-analysis will be~     realized. Patient enrollment in the study will start in April 2008 and estimated to end in~     september 2009.~   "
224112|NCT00625040|"~     To evaluate the impact of laparoscopic adjustable gastric banding (LAGB) on beta-cell~     function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones~     (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) in~     morbidly obese patients and to describe the pathophysiological mechanisms involved in the~     amelioration of glucose homeostasis during long-term weight loss.~   "
224113|NCT00625027|"~     The purpose of this study is to compare the rate of non-urgent emergency department use~     between three groups of patients: those who were referred to the emergency department by~     Telehealth Ontario; those who were referred by a physician; and those who arrived without~     being advised by a nurse or a doctor.~   "
224114|NCT00625014|"~     We hypothesized that short-term treatment with haloperidol induces insulin resistance through~     a mechanistic route that is independent of weight gain. We therefore treated healthy~     non-obese men with haloperidol for 8 days, and studied the impact of these intervention on~     glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution~     technology and indirect calorimetry.~   "
224115|NCT00625001|"~     Turner Syndrome (TS) is associated with osteopenia and osteoporosis. Reduced bone mineral~     density (BMD) and increased risk of fractures are present in many younger and middle-aged~     women with TS. The objective is therefore to describe longitudinal changes in BMD in TS.~      The study is an observational follow-up study. Examinations at baseline, after 5 and 10~     years.~      Bone mineral density is measured by dual energy x-ray absorptiometry (DEXA) and bone turnover~     by bone markers.~      Main Outcome Measures: Bone mineral density (BMD; grams/ square centimetre) were measured at~     lumbar spine, hip and the non-dominant forearm.~   "
224116|NCT00624988|"~     The purpose of this investigation is to determine the effect of lower limb vibration therapy~     on bone density in the tibia in patients with spinal cord injury. The second purpose is to~     assess the neuromuscular junction variability at the motor units of the tibialis anterior~     muscle after a sequence of lower limb vibration therapy~   "
224117|NCT00624975|"~     The purpose of this study is to confirm the safety and immunogenicity of Peru-15 vaccine in~     infants when given simultaneously with measles vaccine.~   "
224118|NCT00624962|"~     RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger~     patients receiving chemotherapy for cancer.~      PURPOSE: This clinical trial is studying how well tube feedings work in younger patients~     receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome,~     or high-risk solid tumors.~   "
224119|NCT00624949|"~     An observational study of 102 women with Turner syndrome followed for 6 years with a~     two-yearly examination including ECHO, MRI of the heart and 24 ambulatory blood pressure. It~     has been found that besides an significantly increased risk of congenital cardiac~     malformations, TS have an increased risk of developing cardiac disease including the life~     threatening condition of aortic dilatation and rupture. The aim of the study is to describe~     the cardiac conditions of TS, evaluate different methods of examination and identify possible~     risc factors.~   "
224120|NCT00624936|"~     RATIONALE: Drugs used in chemotherapy, such as azacytidine work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Bortezomib may stop the growth of cancer cells by blocking blood flow to the cancer and by~     blocking some of the enzymes needed for cell growth. Giving azacytidine together with~     bortezomib may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     giving together with azacytidine in treating patients with relapsed or refractory acute~     myeloid leukemia or myelodysplastic syndromes.~   "
224121|NCT00624923|"~     The hypothesis is that western lifestyle, with sedentary behaviors and caloric excess promote~     a chronic, subacute inflammatory state that participates in the development and progression~     of atherosclerosis. We will evaluate the effects of targeting inflammation using the~     anti-inflammatory drug salsalate, compared to placebo, on coronary artery plaque volume~     assessed by multi-detector computed tomographic angiography (MDCTA). The TINSAL-CVD study is~     a randomized, double-masked, placebo-controlled, 2 arm, clinical trial.~      The purpose of the study is to compare the effect of salsalate or placebo on sub-acute~     inflammation and coronary plaque, in people with cardiovascular disease. Participants are~     randomized to active intervention (salsalate) or placebo interventions for a period of 30~     months. The primary endpoint is change in plaque volume in the coronary arteries assessed by~     MDCTA from baseline to 30 months.~   "
224122|NCT00624910|"~     The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and~     effective in reducing the amount of narcotic pain medication needed to control pain during~     the first 24 hours after abdominal hysterectomy surgery.~   "
224123|NCT00624884|"~     Velocity Vector Imaging may provide reliable and detailed information on left ventricular~     segmental function in asymptomatic patients with moderate-to severe AR. This may help to~     identify subclinical myocardial dysfunction in order to operate early enough to prevent~     postoperative heart failure and restrict unnecessary early operation which could be~     associated with operative risks and mortality related to prosthetic valves.~   "
244328|NCT00356005|"~     The purpose of this study is to investigate the efficacy of azithromycin combination therapy~     with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.~   "
224124|NCT00624871|"~     Oxygen radicals and inflammation are important causes for brain injury in neonates following~     perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using~     both of vitamin C and ibuprofen. The efficacy of these 2 drugs when combined in protecting~     the human brain has not been studied. We aimed in this study to test the hypothesis that a~     combination of anti-oxidants (vitamin C) and anti-inflammatory (ibuprofen) drugs can decrease~     the brain injury in perinatal asphyxia and improve outcomes when given to infants immediately~     after birth.~   "
224125|NCT00624858|"~     The purpose of this study is to determine whether a combination of naltrexone SR and~     bupropion SR is safe and effective in the treatment of major depression in overweight or~     obese subjects.~   "
224126|NCT00624845|"~     The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP)~     compared with vehicle irrigation solution for prevention of pain and pain relief in subjects~     undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain~     Scores in the immediate 24-hour postoperative period and for seven days postoperatively.~   "
224127|NCT00624832|"~     This study was intended to demonstrate that patients with standard and high immunoglobulin E~     (IgE) levels can be protected from allergen induced broncho-constriction by Xolair~   "
224128|NCT00624819|"~     This protocol posting deals with objectives & outcome measures of the extension phase up to~     48-50 months post booster vaccination, to assess long-term antibody persistence in children~     at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal~     conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a~     separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in~     order to comply with the FDA AA (Sep 2007).~   "
224129|NCT00624806|"~     The Veteran's Health Administration (VHA) is a national leader in using distance technology~     to monitor patients' self-care via an in-home messaging device with disease management~     protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders~     (SCI/D) population. Our objective is to develop the tools necessary for implementing a new~     home telehealth program to manage community-dwelling veterans with SCI/D at high risk of~     developing pressure ulcers (PrUs).~   "
224130|NCT00624793|"~     The subjects in this research study will be 159 men and women with HIV infection who have a~     history of chronic nausea for three months or greater and show evidence of two or more~     episodes of nausea and/or report a duration of two hours or more (per day) in baseline~     symptom diaries. Subjects will be randomized (by chance) to one of three conditions:~     Condition 1, subjects receive Standard acupuncture (active treatment); Condition 2, subjects~     receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis (active~     treatment); Condition 3, (Control Group), subjects receive Sham acupuncture. Subjects in~     Conditions 1, 2, & 3 will attend scheduled sessions over 24 weeks.~   "
224131|NCT00624780|"~     The purpose of this study is to characterize the safety and efficacy in patients with~     generalized anxiety disorder after short- (3 months) and long-term (6 months) use of~     Pregabalin (Lyrica).~   "
224132|NCT00624767|"~     Insulin is a hormone which is produced by the human pancreas for the lowering of blood sugar.~     In patients who don't produce enough insulin, additional insulin must be given several times~     per day by injections. Nastech Pharmaceutical Company Inc. has developed a new insulin nasal~     spray, as a possible way to improve patient compliance with intensive insulin treatment~     plans. This study is being conducted to see how Nastech's insulin nasal spray affects~     post-meal glucose levels compared with rapid acting insulin (i.e., insulin aspart) in Type 2~     diabetics who are already taking oral antidiabetic medications and/or insulin therapy.~     Insulin aspart is marketed as NovoLog® in the United States. The safety of insulin nasal~     spray and how well it is tolerated as compared to NovoLog will also be evaluated.~   "
224133|NCT00624754|"~     The usual treatment for obstructive airway disease (OAD) after allogeneic hematopoietic stem~     cell transplantation (AHSCT) , which is related to graft versus host disease (GVHD), consists~     of intensification of systemic immunosuppressive therapy.~   "
224134|NCT00624741|"~     This compassionate use study is designed to monitor safety in patients who have been doing~     well on pergolide therapy, wish to continue treatment, and have not been able to tolerate~     alternative treatments.~   "
224135|NCT00624728|"~     18F-Fluorothymidine is a recently developed PET tracer to image tumor cell proliferation.~     Very few data report an interest of using such a tracer for cerebral malignant tumor~     management. In our project, we want to compare the tumoral volumes obtained with PET and MRI,~     with the gold standard histopathological diagnosis according to the WHO grading malignancy~     scale and the Ki-67 proliferation index, for preoperative evaluation as much as for tumoral~     postoperative residue evaluation. Furthermore, we want to explore the interest of 18F-FLT-PET~     volume to better delineate tumoral volume in radiotherapeutic management of gliomas.~   "
224136|NCT00624715|"~     This study attempts to characterize the effects of tetrahydrocannabinol (THC).~     Tetrahydrocannabinol is the active ingredient of marijuana, cannabis, ganja, or pot. This~     study will involve healthy volunteers who 1) have no history of alcoholism in their family or~     2) have a family history of alcoholism. This study looks at individuals with or without a~     family history of alcoholism to determine if there is a difference between the two groups in~     the response to THC.~   "
224137|NCT00624702|"~     This study will explore information on whether changing the salt formulation of indacaterol~     affects the incidence of post-inhalation cough.~   "
224138|NCT00624689|"~     Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity~     and cardiovascular diseases, neurological development and morbidity in infections.~      The investigators' hypothesis is that a modified formula with reduced energy and protein~     content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins~     and phospholipids will reduce the difference between formula-fed and breast-fed infants.~   "
224152|NCT00624494|"~     The aim of the present study was to evaluate the usefulness of an algorithm based on~     hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with~     continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative~     management of patients undergoing OPCAB.~   "
224153|NCT00624481|"~     This study is being conducted to compare the effect of increasing nasal teriparatide dosing~     on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy~     in postmenopausal women with low bone mineral density.~   "
224139|NCT00624676|"~     Acne vulgaris is a frequent inflammatory skin condition involving the pilosebaceous unit and~     affecting more than 80% of teenagers. Mild to moderate acne vulgaris is usually treated with~     topical agents such as benzoyl peroxide, retinoids and antibiotics. These treatments can be~     associated with local tolerance problems and/or antibiotic resistance. Salicylic acid has~     been shown to be an effective treatment for acne. LHA is a lipophilic hydroxy acid derivative~     of salicylic acid that has comedolytic and antibacterial properties.~      The objective of this trial was to compare the efficacy and tolerance of a cream formulation~     containing 0.3% LHA (LHA formulation) to a 5% benzoyl peroxide gel.~   "
224140|NCT00624663|"~     Rivastigmine is a carbamate, approved by the FDA for the treatment of mild to moderate~     dementia associated with Alzheimer's and Parkinson's diseases. Studies conducted in the~     Israel Institute of Biological Research (IIBR) have yielded encouraging results in utilizing~     rivastigmine pre-treatment as an alternative to pyridostigmine in partially protecting~     against organophosphate poisoning, particularly protecting the central nervous system.~      The target population for this indication may consist of otherwise healthy people (e.g.~     soldiers). Although the treatment regimen has not been established yet it is assumed, based~     on animal experiments, that rivastigmine is likely to be administered in repeated doses. In~     this setting, further evaluation of the drug's effects and pharmacokinetics in young healthy~     subjects is warranted.~      The objectives of this study are: 1) To assess the safety and tolerability of repeated~     rivastigmine administration (1.5 mg and 3 mg) in young healthy male volunteers; 2) To~     determine the pharmacokinetic profile of rivastigmine (1.5 mg and 3 mg) following a single~     and multiple dose administrations; 3) To assess the extent of blood ChE inhibition following~     a single and multiple administrations of rivastigmine and 4) To correlate physiological and~     behavioral effects with blood rivastigmine concentrations and blood ChE inhibition in these~     subjects.~      This double-blind, placebo-controlled study will be divided in 3 identical periods, preceded~     with a two-day initial training in performing cognitive performance tests. Each period will~     consist of in-house confinement for 5 days in which rivastigmine will be administered 5 times~     at an interval of 12 hours. During each period, each subject will receive either rivastigmine~     1.5 mg X 5, or either rivastigmine 3.0 mg X 5 or placebo X 5. The treatment in each period~     will be randomly assigned in a crossover manner. Rivastigmine pharmacokinetics will and~     acetylcholinesterase inhibition will be assessed after the first and the last dose of each~     period and will be correlated with physiological and cognitive parameters: performance tests,~     visual functions, peak airway flow, saliva production (sialometry) and vital signs.~      The emergence of adverse events will be monitored throughout the study~   "
224141|NCT00624650|"~     The purpose of this study is to test a treatment that tries to reduce the amount of fluid in~     the lungs of subjects with acute lung injury to see if this is helpful.~   "
224142|NCT00624637|"~     This study aims to determine the effect of massage with or without aromatherapy on infant´s~     level of distress~   "
224143|NCT00624624|"~     The purpose of this study is to determine the natural course of the androgen profile after~     bariatric surgery in men with obesity related hypogonadotropic hypogonadism.~   "
224144|NCT00624611|"~     When a child undergoes heart surgery, a heart lung machine is used to keep blood flowing~     while the child's own heart is stopped. After surgery, a significant amount of the child's~     own blood is left in this machine. In the case of small children, the relative amount of~     blood potentially lost to the child in this way is very large.~      In older children, and those who have undergone less complicated surgery, this blood can all~     returned to the child. Giving the child back his or her own blood makes is less likely that~     the child will need a transfusion of donated blood.~      However, in younger children, or in children who have undergone more complicated surgery,~     most or all of this blood is thrown away. This is because of worry that returning this blood~     may cause bleeding, and excessive bleeding is one of the most feared complications of heart~     surgery.~      This project will explore a method whereby the red blood cells left in the heart lung machine~     can be returned to children without increasing the risk of bleeding. It will also carefully~     examine the exact causes of higher bleeding risk in children getting their own blood back so~     that in the future, all children can have their own blood returned at the end of surgery.~   "
224145|NCT00624598|"~     The purpose of this study is to evaluate the short-term effect of a technology based weight~     reduction program for obese (BMI > 30 kg/m2) adults in a primary care office.~   "
224146|NCT00624585|"~     The main purpose of this study is to learn how patients with myelodysplastic syndrome (MDS)~     respond to the study drug dasatinib. The study drug, dasatinib, has been approved by the U.S.~     Food and Drug Administration (FDA) for treatment of leukemia, but has not been approved for~     the treatment of other kinds of cancer. The use of dasatinib in this study is considered~     experimental.~   "
224147|NCT00624572|"~     The purpose of this study is to evaluate the action of the chlorexidine as intracanal~     medicament in the reduction of the levels of bacteria inside root canals of primary molar~     teeth with pulpal necrosis.~   "
224148|NCT00624559|"~     The purpose of this study is to determine if the drug Celebrex changes the way the kidney~     gets rid of salt and maintains blood pressure.~   "
224149|NCT00624546|"~     Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux~     therapy are well known and extensively studied, little is known of the genetic events~     occurring in response to proton pump inhibitor therapy. Preliminary data from our laboratory~     has shown, for example, that COX-2 expression is not only elevated in patients with~     gastroesophageal reflux disease but also can be correlated with pathologic esophageal acid~     exposure on 24 hour pH monitoring. Similar studies have suggested that antireflux surgery may~     normalize COX-2 gene expression. In contrast studies following ablation of dysplastic~     Barrett's epithelium have shown persistence of genetic changes associated with altered~     cellular function, despite the return of the histologic appearance to normal. Several key~     mediators of inflammation, metaplasia (Barrett's) and neoplasia have now been well~     characterized and shown to be important factors in the pathogenesis of esophageal injury. It~     is likely that successful antireflux therapy returns altered expression of these mediators~     toward normal although this hypothesis remains largely unexplored. The aim of this study is~     to investigate gene expression of key mediators of the spectrum of esophageal mucosal injury~     and the response to antireflux therapy.~      Hypothesis: Antireflux therapy (proton pump inhibitor and surgical fundoplication) normalizes~     the expression of genes known to be involved in the pathogenesis of inflammation~     (esophagitis), metaplasia (Barrett esophagus) and neoplasia (adenocarcinoma).~   "
224150|NCT00624533|"~     The purpose of this randomized controlled trial was to assess the effectiveness of GDS~     Treatment Method for patients with subacute or chronic non-specific low back pain in Primary~     Care of Spanish National Health Service.~   "
224151|NCT00624520|"~     The purpose of this study is to assess the effectiveness of a 10 week program of Stress~     Management versus control Patient Education sessions on cardiac responses to mental stress in~     veterans with Implantable Cardioverter-Defibrillators~   "
224155|NCT00624455|"~     Gabapentin is a medicine that has been used in adults (but not yet in children) to treat pain~     after surgery. In children it has been used for many years to treat other conditions and has~     been shown to be very safe.~      Removal of tonsils is a common operation with each child experiencing a similar pattern of~     pain; this makes it good for looking at the effect of pain relieving medicines. In our study~     each child will get the same operation and medicines, as they would have normally. Before the~     operation and in a random way, half will get gabapentin and half will get the same syrup but~     with no gabapentin. Afterwards we will record how much pain the children have and how much of~     our standard medicine is needed to make them comfortable. We expect both of these results to~     be lower in the half who received gabapentin. We will also record the amount and type of~     unwanted effects, both from the gabapentin and from any other pain relief medicines.~   "
224156|NCT00624442|"~     This study will assess the safety, tolerability, and pharmacodynamics of CK-1827452 infusion~     in patients with stable heart failure.~   "
224157|NCT00624429|"~     The Early Head Start program serves lower socioeconomic inner-city children from birth to 3~     years. This population has a higher incidence of asthma due to increased exposures. The~     primary objective of this study is:~      To evaluate the effect of early identification of these high risk, inner-city asthmatic~     infants, age 1-3 years, and early treatment with pulmicort respules on asthma morbidity~     (asthma symptoms and use of rescue medications), infant pulmonary functions, and use of~     health care resources (unscheduled clinic visits, emergency room visits and~     hospitalizations).~      To obtain pilot behavior information using Carey Temperament Scale, Bitsea and expand to~     Itsea if indicated.~   "
224158|NCT00624416|"~     The purpose of this study is to test whether injected medications will increase the amount of~     fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined~     with isoproterenol (a drug given for asthma) versus using isoproterenol alone. We will also~     test if injections of isoproterenol and prednisolone will shrink the size of lipomas, which~     are benign fatty tumors.~   "
224159|NCT00624403|"~     The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal~     vent. The aim of this study is to compare this device to the LMA ProSeal. The study is~     approved by the institutional ethic committee. 222 patients will be enrolled in each group.~     The objectives of the study will be to compare insertion success rate, leak pressure,~     ventilatory parameters and adverse event rate.~   "
224160|NCT00624390|"~     The purpose of this research study is to obtain preliminary data of the safety and~     effectiveness of Sepraspray in a limited number of patients who are under going a~     laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity~     following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion~     prevention barrier after laparoscopic myomectomy versus no adhesion barrier.~   "
224161|NCT00624377|"~     The purpose of this study is to monitor the change in the health status of severe COPD~     patients after the initiation of Tiotropium therapy. This will be assessed by the physician`s~     global evaluation of the patient`s health status on a 8-point scale. This measure has been~     shown to correlate with a established standard measure of the patients health related quality~     of life. The primary analysis in this trial will only include patients not pre-treated with a~     long-acting beta-agonist to establish a clear efficacy signal in this patient population. As~     the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse~     patients who are pretreated with long-acting bronchodilators to put the changes in the health~     status in a likely real world context. In parallel to these evaluations of the health status,~     the lung function response of the patients will be assessed to gain an established objective~     measure of treatment response.~   "
224162|NCT00624364|"~     This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and~     safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood~     glucose control in type 2 diabetes.~   "
224163|NCT00624351|"~     The primary objective of the study is to assess the dose response and the dose frequency of~     epratuzumab in patients with SLE.~   "
224164|NCT00624338|"~     This study is to evaluate the efficacy and safety of atacicept compared to placebo in~     preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the~     optimal dose of atacicept for treatment of subjects with SLE and gain information on the~     effect of atacicept on markers specific to its mechanism of action (MoA) and their~     correlation to disease activity/progression. Study medication will be administered through~     subcutaneous (under the skin) injections, beginning with twice weekly injections for the~     first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a~     safety follow-up period of 24 weeks will be conducted.~   "
224165|NCT00624325|"~     For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy~     we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48~     weeks in combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects~     in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks. We~     expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared~     to thrice weekly or daily subcutaneous injection of IFN-a2b, and increased antiviral activity~     and biologic potency due to sustained and higher levels of a fully potent interferon protein.~   "
224166|NCT00624312|"~     The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit~     prior to a major surgical oncology operation.~   "
224167|NCT00624299|"~     The surgery to correct leg & foot deformities in children is a lengthy, & sometimes,~     difficult procedure. Metal frames are attached to the leg and / or foot and over a period of~     time the frame is manipulated to obtain the corrected position. During this period the~     muscles & skin become very tight which causes pain & may pull the joint out of position. When~     this happens it is sometimes necessary to stop the treatment before the best position is~     obtained. This means that not only is the child left with an inadequate result but that~     further surgery is required in the future.~      If the tension could be removed whilst the treatment is underway this would reduce the pain,~     the possibility of joint damage & potentially allow a more satisfactory to be obtained~     without the need for further surgery.~      Botulinum toxin or Botox, as it is commonly called, has the potential to temporarily reduce~     the tension in the muscles without causing permanent damage.~   "
224168|NCT00624286|"~     This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily~     (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).~   "
224170|NCT00624260|"~     The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the~     three years following the tumoral resection with curative aim. Therefore, a prolonged~     follow-up and an intense monitoring are recommended to detect these recurrences precociously.~     Nevertheless, current consensual morphological and biological examinations are not very~     contributory, of difficult interpretation and expensive. The metabolic imagery in~     tomoscintigraphy by emission of positron coupled with the scanner, called PET-TDM, allows to~     identify more specifically recurrences, analyzes the whole body, detects hepatic metastasis~     more precociously and give some benefice for early diagnosis of lymph nodes recurrence. The~     principle purpose of this study is to evaluate if the systematic follow-up per PET-TDM allows~     detecting more often recurrences accessible to a curative surgery. We make the hypothesis~     that the systematic practice of PET- tomodensitometry (TDM) during the follow-up of CRC~     allows to decrease non curative recurrences appearance during the 3 years follow-up after a~     curative surgery.~   "
224171|NCT00624247|"~     The objective of this non-randomized, controlled, trial is to evaluate the optimal time to~     approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that~     maximizes the number of individuals able to demonstrate capacity to consent and willingness~     to receive HIV testing.~   "
224172|NCT00624234|"~     The goal of this trial is to determine if children with neurofibromatosis type 1 who have~     reading disabilities respond the same way—both behaviorally and neurobiologically—to~     specialized treatment programs as children with idiopathic reading disabilities do, and to~     determine which intervention is best for particular learner profiles.~   "
224173|NCT00624221|"~     Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant~     technique that replaces only the diseased endothelial cell layer of the patient's cornea. The~     DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the~     patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time~     of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added~     service. The purpose of this study was to compare outcomes with eye bank pre-cut and~     surgeon-dissected donor grafts for DSEK.~   "
224174|NCT00624208|"~     We are investigating a new technique for testing the effect of drugs on electrical activity~     in the heart. Disturbances of this electrical activity can cause life-threatening changes to~     heart rhythms. A better way of measuring the risk has recently been developed, and our~     research team leads the world in using this tool to test the safety of drugs used in~     children. Children and their families want to know that the drugs being used are safe, as do~     the doctors that care for them. In this study, we will take heartbeat tracings (ECGs) from 60~     children before and during their operations. The ECGs will then be checked by a children's~     heart specialist. Differences on the ECGs will be related to the presence and amount of drug~     (droperidol or ondansetron) given. We expect that the droperidol or ondansetron will not~     cause any changes that show increased risk of abnormal heart rhythms. We can then tell~     patients, parents and regulatory authorities of the safety profile of this aspect of the~     drug; moreover, the study can be used as a model for testing many other drugs used in~     hospitals.~   "
224175|NCT00624195|"~     CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS~     (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI).~      The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as~     compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different~     domains of functioning known to be affected by HIV.~      It is hypothesized that participants in the CNS-T arm will have greater improvement in~     neurocognitive functioning than those in the non-CNS-T arm.~      The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T~     HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL).~      It is also hypothesized that although CSF viral suppression will be more frequent in the~     CNS-T arm, plasma viral suppression will be similar in the two treatment arms.~   "
224176|NCT00624182|"~     The purpose of this study is to evaluate the safety, tolerability, and immune response of~     different doses of URLC10 peptide emulsified with Montanide ISA51 in combination with~     gemcitabine. Recommended phase II dose will be also determined.~   "
224177|NCT00624169|"~     The objective of this study is to implement an optimized perioperative course for patients~     surgically treated for peptic ulcer perforation in order to improve the outcome for these~     patients.~      The optimized perioperative course consists of a number of interventions carried out before,~     during and after surgery.~   "
224178|NCT00624156|"~     We are doing this study to see if writing about life experiences helps women adjust to breast~     cancer that has spread. We will compare two groups. One group will write about their breast~     cancer experience. The other will write about their daily activities. What we learn from this~     study may help us to find new ways to help women cope with breast cancer that has spread.~   "
224179|NCT00624143|"~     Hypothesis:Oral Voriconazole will be as effective as intravenous Amphotericin B as antifungal~     prophylaxis in induction of acute leukemia (ALL, AML) in pediatric patients, with less~     toxicity and more convenience.~   "
224180|NCT00624130|"~     The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a~     marketed comparator.~   "
224181|NCT00624117|"~     The purpose of this study is to evaluate the effectiveness of progressive strength training~     after rotator cuff and labrum operation of the shoulder joint.~   "
224182|NCT00624104|"~     The purpose of the study is to investigate and compare the lipid metabolism in lean and obese~     individuals. We want to investigate the effect of postprandial hyperinsulinaemia on~     VLDL-triglyceride metabolism~   "
224193|NCT00623961|"~     This study seeks to validate clinically evoked or obtained objective pain signs with the~     patient's corresponding quantified subjective pain symptoms. This will allow for validation~     of objective clinical pain signs to then be used to begin to classify patients with pain~     based on symptoms and signs. This then can be used as a basis for further study of~     neuropathic pain mechanisms in human patients.~   "
224371|NCT00621608|"~     The purpose of this study is to determine if HBOT plus standard wound care is more effective~     than standard wound care alone at preventing the need for major amputation (metatarsal and~     up) in patients with diabetes mellitus (Type 1 or 2) with moderate to sever chronic wounds of~     lower limbs.~   "
224372|NCT00621595|"~     To test cognitive abilities of 8-11 year old children under conditions of fasting or~     receiving a full school breakfast.~   "
224183|NCT00624091|"~     Background: Prognosis of infective endocarditis is poor and has remained steady over the last~     four decades. Several nonrandomized studies suggest that early surgery could improve~     prognosis.~      Methods: The early surgery in infective endocarditis study (ENDOVAL 1) is a multicenter,~     prospective, randomized study designed to compare the state-of-the-art therapeutic strategy~     (that advised by the international societies in their guidelines) with the early surgery~     strategy in high-risk patients with infective endocarditis. Patients with infective~     endocarditis without indication for surgery will be included if they meet at least one of the~     following: 1) early-onset prosthetic endocarditis; 2) Staphylococcus aureus endocarditis; 3)~     periannular complications; 4) new-onset conduction abnormalities; 5) vegetations longer than~     10 mm in diameter; 6) new-onset severe valvular disfunction. A total of 216 patients will be~     randomized to either of the two strategies. Stratification will be done within 3 days of~     admission. In the early surgery arm, the procedure will be performed within 48 hours of~     randomization. The only event to be considered will be death within 30 days. The study will~     be extended to 1 year. In the follow-up substudy, death and a new episode of endocarditis~     will be regarded as events.~      Conclusion: The early surgery in infective endocarditis study (ENDOVAL 1), the first~     randomized in endocarditis, will provide crucial information regarding the putative benefit~     of early surgery over the state-of-the-art therapeutic approach in high-risk patients with~     infective endocarditis.~   "
224184|NCT00624078|"~     This treatment protocol will enable therapeutic use of Anascorp in the management of systemic~     manifestations of scorpion sting envenomation, in patients for whom antivenom would otherwise~     be unavailable. The working hypotheses are as follows:~        1. The investigational antivenom is safe as treatment of scorpion sting envenomation.~        2. The investigational antivenom is effective as treatment of scorpion sting envenomation.~   "
224185|NCT00624065|"~     Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2~     essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline.~     Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril +~     placebo. Subjects will be uptitrated over a 6 week period until target blood pressure~     (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of~     subjects who achieve target blood pressure after 6 weeks of treatment.~   "
224186|NCT00624052|"~     The primary objective of this trial is to assess the efficacy and safety of the fixed dose~     combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg~     (T80/A10) during open-label treatment for at least six months.~      An additional objective is to assess the efficacy and safety of concomitant administration of~     either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of~     hypertension.~      The primary endpoint is the proportion of patients achieving DBP control (defined as mean~     seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study~     treatment) at six months of treatment or at last trough observation during the treatment~     period (i.e. last trough observation carried forward).~   "
224187|NCT00624039|"~     The purpose of this study is to investigate the changes in the pilocarpine-induced ciliary~     body movement before and after cataract extraction in order to determine the effect of lens~     sclerosis on the ciliary muscle contractility.~   "
224188|NCT00624026|"~     The study objective is to evaluate the effects of memantine treatment on communication~     abilities and other cognitive abilities in moderate to severe DAT patients.~   "
224189|NCT00624013|"~     This proposed study will test the following hypothesis: Treating depression in Hispanics and~     African Americans with diabetes will improve their HbA1c and quality of life while on~     intervention and six months after intervention.~   "
224190|NCT00624000|"~     Stroke is the third leading cause of death in the United States, responsible for 158,488~     deaths in 1998 (American Heart Association). Nationwide, each year, an estimated 600,000 to~     750,000 people suffer a new or recurrent stroke. Cerebral infarction comprises 80% of all~     strokes and is the result of a complex series of cellular metabolic events that occur rapidly~     after interruption of blood flow to a region of the brain. The extent of the brain damage is~     dependent on the duration and severity of the cerebral ischemia. Acute thrombus formation or~     migration is the principal cause of blood flow interruption in at least 75% of cerebral~     infarctions. In several animal models of focal cerebral ischemia, restoration of cerebral~     blood flow within two to six hours after initial occlusion has been associated with smaller~     volumes of cerebral infarction and improved functional outcome. An effective way of~     dissolving the thrombus is by administration of recombinant tissue plasminogen activator or~     Activase (Alteplase, rt-PA), which promotes the proteolytic action of plasmin from~     plasminogen at the site of a clot. In this study, the drug, Activase, will be administered in~     subjects with acute ischemic stroke (AIS) intravenously (IV) or by local intra-arterial (IA)~     injection. The use of the intravenous administration within 3 hours of stroke symptom onset~     is FDA approved whereas the intra-arterial administration, despite evidence of potential~     benefit, is not currently FDA approved. Although not FDA approved, this study will evaluate~     the effectiveness of IA thrombolysis with Activase, used in AIS because of its higher rate of~     recanalization , potential expansion of the time window out to 6 hours, and lower doses of~     thrombolytic agent used compared with systemic or intravenous Activase. The study is designed~     to test the feasibility and provide preliminary safety data regarding the relative benefits~     and risks of IA Activase as compared to IV Activase when administered per the NINDS rt-PA~     stroke study protocol, i.e. randomized within 3 hours of onset of symptoms of ischemic stroke~     then treated within 3 hours in the IV Activase arm and within 4 hours in the IA Activase arm.~   "
224191|NCT00623987|"~     Background. The optimal duration of oral anticoagulant treatment in patients with idiopathic~     Deep Vein Thrombosis (DVT)of the lower limbs is still uncertain. Residual Vein Thrombosis~     (RVT) has been found able to establish the patient' risk for recurrent thrombotic events. In~     the present study we conducted a RVT-based therapeutic strategy, withholding OAT after 3~     months in patients without RVT while continuing anticoagulants for at least additional 9~     months in those in whom RVT persists.~      Methods Patients with a first episode of symptomatic unprovoked proximal Vein Thrombosis (VT)~     were given Oral Anticoagulant Treatment (OAT) for 3 months. Residual Vein Thrombosis (RVT),~     ultrasonographically-detected, will be then assessed. Patients without RVT did not continue~     OAT (Group B), whereas those with RVT will continue OAT for at least additional 9 months.~     Patients were followed-up prospectively focusing on the study outcomes: occurrence of~     recurrent venous thromboembolism and major bleeding over a period of at least 12 months after~     OAT discontinuation.~   "
224192|NCT00623974|"~     Primary Objective:~      -To identify the optimal dose of a seven-day course of twice-daily teriparatide as compared~     to standard therapy for hypocalcemia in patients after total thyroidectomy and/or extensive~     neck dissections (pharyngectomy, laryngectomy,unilateral, bilateral / central neck,~     mediastinal lymph node neck dissections), with which serum calcium will be raised to~     corrected serum calcium levels of 8-10.5mg/dL and maintained within this range until the end~     of the treatment course.~   "
224194|NCT00623948|"~     This project will evaluate the feasibility of using a fully implanted gluteal stimulation~     system for the prevention of Pressure ulcers. The specific goal of this study will be a pilot~     clinical trial of veterans with reduced mobility in order to establish clinical efficacy of a~     2-channel bilateral gluteal stimulation system. A two-arm crossover study of wheelchair users~     with complete SCI will be carried out. All study participants will receive a fully implanted~     system incorporating implanted IM electrodes and a Micropulse I IPG stimulator (NDI Medical).~     Group assignments will be determined at enrollment using a modified randomization scheme. A~     total of 10 subjects will be recruited to the pilot clinical trial.~   "
224195|NCT00623935|"~     The prognosis for older individuals with acute myelogenous leukemia (AML) has been~     historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients~     with AML in first complete remission are routinely treated using a full intensity~     (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient~     with AML, full intensity therapy transplants have been greatly limited by increased rates of~     toxic effects related to this type of conditioning regimen. Reduced intensity~     (non-myeloablative) conditioning regimens have been used in a number of clinical settings,~     including AML therapy, to lessen the regimen related toxicity in the older patient. Recent~     data from the University of Michigan Blood and Marrow Transplant Program suggests improved~     survival for individuals > 55 years in age undergoing reduced intensity, transplants from~     unrelated donors. This study will investigate the safety and efficacy of this treatment~     option for older patients with AML, with the primary goal being to improve the survival and~     lifespan for older patients with AML.~   "
224196|NCT00623922|"~     The purpose of this study is to explore the effect of patient education (PE) in patients with~     arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used~     as an element in the treatment of patients with chronic complaints. Our hypothesis is that~      - PE delivered as group education, followed by an individual nurse consultation increases the~     patients wellbeing an ability to cope with the disease.~   "
224197|NCT00623909|"~     The purpose of this study is to demonstrate the safety of the AvicennaTM class IV laser for~     application over the skin of human subjects. In addition, we seek to measure the~     effectiveness and utility of this class 4 laser therapy in the treatment of post-thoracotomy~     pain syndrome.~   "
224198|NCT00623896|"~     The method of ECG recording with the use of three bipolar leads A (anterior), D dorsalis) and~     J (or I - inferior) was introduced in 1938 by German electrophysiologist W. Nehb. Being~     positioned on the chest in the immediate proximity to the heart, and being aligned to the~     anatomic position of the heart, these leads are very sensitive and allow accurate diagnostics~     of different heart conditions. All the active leads are placed on anterolateral plane of the~     chest wall requiring little anatomical window making this technique convenient for express~     diagnostics using compact electrocardiographic devices without any loss of valuable~     information.~      Active electrodes are located on the chest in the following order: 1st- red standard~     electrode placed in the second intercostal space to the right from sternum corresponding to~     V1 for standard 12-lead ECG recording, 2nd- green standard lead placed in the position~     corresponding to V4; 3rd- yellow in the position V7. Then ECG recorded as if in the I~     standard lead would be defined as Nehb's D, which records the potential on the posterior left~     ventricle wall; II standard lead would produce Nehb's A which corresponds to the potential on~     the anterior wall of the left ventricle, and III standard lead would record Nehb's J, which~     reflects the potential on the diaphragmatic surface of heart.~      Been simple and informative, this ECG recording modality may be applicable for usage with~     compact portable cardiographer devices for express diagnosis in different situations and may~     allow faster and more adequate outpatient response in the case of emergencies.~      Nehb 3 leads ECG can provide the clinician with portable, reliable, comprehensive and~     constant ECG monitoring and by this facilitate rapid diagnosis and treatment of STEMI.~   "
224199|NCT00623883|"~     We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their~     prevention would correlate with cancer risk and their elimination would reduce that risk. In~     this study we wished to (1) establish the feasibility of stain-enhanced magnification~     colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of~     ACF, and (3) investigate the natural history of ACF and the durability of their elimination.~   "
224200|NCT00623870|"~     This study will determine the maximum tolerated dose of RO5045337 and the optimal associated~     4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with~     hematologic neoplasms. A first cohort of patients will receive the starting dose of~     20mg/m2/day orally, once daily for 10 days in each 28 day cycle. Subsequent cohorts of~     patients will receive dose escalations, and possible changes in dosing schedule, based on~     tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. Different~     formulations of RO5045337 will be tested and the food effect evaluated. The anticipated time~     on study treatment is until disease progression or intolerable toxicity.~   "
224201|NCT00623857|"~     The purpose of this study is to determine to what extent supplementation with zinc and other~     micronutrients are efficacious in preventing malaria in young Tanzanian children.~   "
224202|NCT00623844|"~     Objectives: The PAKT project shall evaluate the effects of an exercise intervention in~     kindergarten combined with an educational training of parents and kindergarten teachers on~     behavior and health status of children.~      Study design: Baseline measurements were performed on more than 700 kindergarten children~     aged 43-67 months in May to July 2007. The kindergartens are located in and around Wuerzburg~     in Germany. Kindergartens were then randomized in an intervention (21 kindergartens) and a~     control (20 kindergartens) group. The intervention group offers a daily exercise class~     lasting at least 30 min. Parents and teachers of the children in the intervention program~     receive educational training. In addition, the children have activity homework involving the~     entire family. The control kindergartens keep their routine. Follow-up measurements of~     physical activity (actigraph), motor skills, body mass index, skinfold thickness, and blood~     pressure take place in January/February 2008, June/July 2008, and September/October 2008. The~     number of accidents in and outside of the kindergartens and the number of children missing~     the kindergarten due to infections are monitored continuously.~      Use of results: If the PAKT program should proof effective, the results will be published in~     scientific journals and made public using the press. With the help of the GEK, the program~     will then be implemented nationwide in kindergartens.~   "
224203|NCT00623831|"~     This was a phase 1, open-label, multiple dose, single-arm study. The mixed bacteria vaccine~     (MBV) was administered at a starting dose of 250 EU (1 µL) and escalated in each subject to a~     dose inducing the desired pyrogenic effect, defined as a body temperature of 38°C to 39.5°C.~     The primary objective was to determine the safety profile of MBV in subjects with malignant~     tumors that expressed the NY-ESO-1 antigen and to identify the dose that induced the desired~     pyrogenic effect. Secondary objectives were to evaluate the immunological effects and tumor~     response of subjects following vaccination.~   "
224204|NCT00623818|"~     This study, conducted at the National Institutes of Health (NIH) and at Walter Reed Army~     Medical Center (WRAMC), will explore the phenomenon of phantom limb pain (a continued feeling~     of pain in an amputated limb) and will use functional magnetic resonance imaging (fMRI) to~     investigate the effect of mirror therapy on phantom limb pain.~      Right-handed people between 18 and 75 years of age who are in the WRAMC Military Amputee~     Research Program and healthy control subjects may be eligible for this study. Participants~     undergo the following procedures:~      Amputees~        -  Questionnaires to assess strength of handedness and footedness and pain perception.~        -  Mirror therapy for phantom limb pain five times a week for 4 weeks in 15-minute~          sessions.~        -  MRI and fMRI scans before starting mirror therapy, after 2 weeks of therapy and after 4~          weeks of therapy. MRI uses a magnetic field and radio waves to image brain tissue. The~          subject lies on a table that can slide in and out of the scanner (a metal cylinder). The~          structural MRI scan lasts about 30 minutes. For fMRI, the subject performs tasks while~          in the scanner in order to show changes in brain activity involved in performing those~          tasks. Subjects are shown pictures of feet and other body parts, are asked to move their~          feet, and receive tactile (touch) stimulation of the foot or other body parts.~      Control Subjects~      One group of control subjects undergoes a single fMRI procedure. A second group of control~     subjects undergoes the same sequence of three fMRIs over the same time period as the amputee~     subjects. None of the control subjects undergo mirror therapy.~   "
224205|NCT00623805|"~     This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin~     (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin +~     Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of~     2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda~     + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease~     progression. Xeloda was administered at a dose of 1000 mg/m^2 orally twice a day on days 1-14~     of each cycle, oxaliplatin at a dose of 130 mg/m^2 intravenously (iv) on day 1 of each cycle,~     and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.~   "
224206|NCT00623792|"~     The purpose of the trial is to determine whether a preoperative lifestyle intervention~     (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related~     parameters prior to bariatric surgery and improve short-term postoperative outcomes.~   "
224207|NCT00623779|"~     The purpose of this study is to assess the safety and tolerability of AZD0837 in patients~     with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for~     up to 3 months.~   "
224208|NCT00623766|"~     To assess the response of melanoma with brain metastases to ipilimumab treatment while~     maintaining acceptable tolerability.~   "
224209|NCT00623753|"~     Vaccines have been very successful in preventing viral infections such as hepatitis B and the~     measles. Viral vaccines work by causing a person's immune system to make cells that will work~     against the virus. Due to the success in treating other viral infections, scientists are~     trying to develop a vaccine for human immunodeficiency virus (HIV). HIV infection is the~     cause of acquired immune deficiency syndrome (AIDS). AIDS is one of the most serious viral~     infections we know.~      This is a research study to evaluate the safety of a possible vaccine against HIV.~     Researchers want to determine that a person's immune system can respond to the HIV before he~     or she is exposed to it. Therefore that person may be able to be protected from infection~     with HIV.~   "
224210|NCT00623740|"~     There is increasing evidence linking a fetal and early neonatal systemic inflammatory~     response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white~     matter injury (WMI) in very preterm infants. Babies with evidence of adrenal insufficiency~     early in life may not be able to control the inflammatory response and are thereby more~     likely to develop BPD than babies who do not show such evidence of inflammation. We designed~     a randomized controlled trial to test the hypothesis whether very preterm babies at high-risk~     of BPD, treated with low doses of HC during the first 10 days of life, are more likely to~     survive without BPD at 36 weeks of post-menstrual age (PMA), compared to babies treated with~     placebo.~   "
224211|NCT00623727|"~     A study to assess treatment with a new formulation of recombinant factor VIII reconstituted~     with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can~     prevent bleeds in subjects with severe haemophilia A.~   "
224212|NCT00623714|"~     The primary goals of this study will be to implement innovative processing and detection~     assays to qualify induced sputum measurements of markers of allergen-induced airway~     inflammation. The results of this study are intended to form a platform to be used in the~     clinical development of novel asthma therapeutics.~   "
224213|NCT00623701|"~     Efficacy and Safety from a high-dosed sublingual grass pollen preparation~   "
224214|NCT00623688|"~     This study will be conducted as a randomized, double blinded, controlled trial. The control~     group will receive albuterol delivered by a nebulizer along with placebo treatments delivered~     by a metered dose inhaler (MDI) with a spacer +/- mask. The experimental group will receive~     albuterol delivered by MDI with spacer +/- mask along with placebo treatments given by a~     nebulizer. Parents, participants, study personnel, nursing staff, and respiratory therapists~     will not know the treatment assignments of participants. The primary outcome will be changes~     over time in an asthma severity score, the Clinical Asthma Score (CAS) (Parkin et al. 1996).~     The secondary outcomes will be total number of albuterol treatments received in the hospital,~     time it take to give treatments, time till subjects' albuterol treatments are given at four~     hour intervals, and the costs of the two types of treatments. The study hypothesis is that~     albuterol delivered by metered dose inhaler with spacer is non-inferior to albuterol~     delivered by nebulizer in the treatment of children hospitalized with moderate to severe~     asthma exacerbations.~   "
224215|NCT00623675|"~     Researchers want to find out if urine heavy metal levels are changed in persons who use~     Mineralox Basic C™ (Mineralox). Mineralox is a zeolite (clinoptilolite) in combination with~     Vitamin C. Zeolites are natural supplements (nutraceuticals) that work at the cellular level~     to remove heavy metals and toxins that are accumulated in every day life safely from the body~     through the urine. The study doctor will give Mineralox to 20 people in this study to see if~     it helps with the heavy metal removal from the body.~   "
224216|NCT00623662|"~     The goal of the study is to determine whether intravenous glucose administration before liver~     resection preserves hepatic glycogen resulting in improved hepatic metabolic function after~     the operation.~      We further investigate whether the benefit of avoiding preoperative fasting is more~     pronounced in patients undergoing more extensive liver resection.~   "
224217|NCT00623649|"~     The purpose of this study is to determine whether a 3-day course of therapy with orally~     administered VCH-916 given at different dosages can effectively reduce the amount of~     circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis~     C-infection. This study will also evaluate the safety and tolerability of treatment with~     VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma~     at various time points during the treatment period.~   "
224218|NCT00623636|"~     This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in~     adult migraineurs. Subjects will self administer study drug in the outpatient setting.~   "
224219|NCT00623623|"~     This study aims at evaluating, in a proof of concept approach, the outcome of patients~     presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in~     either a pre-hospital setting or community hospital emergency room without a PCI facility.~     Following randomisation a strategy of early tenecteplase and additional antiplatelet and~     antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary~     intervention as appropriate (or by rescue coronary intervention if required) in Group A will~     be compared to primary PCI performed according to local standards in Group B.~      The study is exploratory in nature and will examine this medical question. The efficacy and~     safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before~     30 days following randomisation will be evaluated.~      All clinical endpoints of main interest will be assessed as single or composite endpoints for~     evaluation of the trial objective. All statistical tests are of exploratory nature based on~     descriptive p-values for formal statistical hypotheses generation.~   "
224220|NCT00623610|"~     To examine whether temporary immunosuppression with ATG, tacrolimus and MMF allows prolonged~     survival of beta cell allografts in type 1 diabetic patients with early chronic complications~     of diabetes.~   "
224221|NCT00623597|"~     This single arm study will assess the pharmacokinetics, safety and activity of saquinavir~     (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination~     with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6~     years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg~     or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug~     exposures are found to be dissimilar to those previously seen in older children and adults,~     or are associated with toxicities, subsequent dose adjustments will be made. The anticipated~     time on study treatment is 3-12 months, and the target sample size is <100 individuals.~   "
224222|NCT00623584|"~     The goal of this clinical trial is to compare the quality of corneal grafts cultured in a~     serum-free culture medium with a defined composition versus corneal grafts cultured in a~     standard serum supplemented culture medium transplanted in patients with decompensated~     corneal dystrophy~   "
224223|NCT00623571|"~     Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with~     inpatient care in selected elderly patients with acute exacerbation of chronic heart failure~     (CHF).~   "
224224|NCT00623558|"~     The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel,~     cisplatin combination as induction therapy in locally advanced head and neck squamous cell~     carcinoma.~   "
224225|NCT00623545|"~     The purpose of this study is to find out how exenatide causes weight loss. Specifically, the~     study is assessing how exenatide may change how people take in energy (energy intake), as~     well as how it may effect how people use energy (energy expenditure).~   "
224226|NCT00623532|"~     Few previous studies have explored the effects of mind body approaches on health-related~     quality of life (HRQoL) in frail elderly. Cognition and action are an inseparable whole while~     functioning. A new intervention-based approach using familiarity based movements and a~     non-judgmental approach was labeled cognition-action. The investigators aimed to explore~     the effects of two different mind-body exercise types on (HRQoL) in frail institutionalized~     elderly.~      The investigators' main hypothesis is that adaptated physical activity in frail~     institutionalized elderly can improve HRQoL.~   "
224227|NCT00623519|"~     To investigate the global incidence of the endometrial changes in postmenopausal women~     receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.~   "
224228|NCT00623506|"~     Mild traumatic brain injury (TBI) is common among veterans who have served in OEF/OIF~     (Operation Enduring Freedom in Afghanistan/Operation Iraqi Freedom) and other theatres.~     Delayed symptoms may occur following TBI, including cognitive symptoms (impaired attention,~     processing speed, executive functioning), as well as behavioral symptoms such as anxiety,~     depression, and irritability (Fann et al. 2004; Holsinger et al. 2002). Neuroactive steroids~     have neuroprotective effects in rodent models of TBI (Djebaili et al. 2005; Djebaili et al.~     2004; He et al. 2004; Pettus et al. 2005; Roof et al. 1997) and the neuroactive steroid~     pregnenolone and its sulfated derivative also markedly enhance learning and memory in rats~     (Akwa et al. 2001; Flood et al. 1992; Flood et al. 1995; Vallee et al. 1997; Vallee et al.~     2003). In humans, reductions in pregnenolone (George et al. 1994) and its GABAergic~     metabolite allopregnanolone (Uzunova et al. 1998) have been associated with depressive~     symptoms. Pharmacological intervention with the neuroactive steroid pregnenolone could~     therefore result in a multi-targeted treatment approach, potentially improving cognitive~     deficits as well as anxiety and depression symptoms following TBI.~   "
224266|NCT00622999|"~     The prevalence of malnutrition in patients with colorectal cancer is recorded. We want to~     find out, if a malnourished patient has more complications after the elective surgery.~   "
224229|NCT00623493|"~     Objective:~      The ultimate goal of this project is to enhance the capacity of non-mental health clinicians~     working in an Emergency Departments (ED) to recognize and initiate further evaluation of~     children and adolescents at risk for suicide.~      Aim 1: To re-validate the Risk of Suicide Questionnaire (RSQ), a screening tool that assists~     non-psychiatric clinicians in rapidly detecting suicide risk in pediatric patients, in a~     pediatric ED mental health population in the Children s National Medical Center (CNMC) ED.~      Aim 2: To determine the utility of a suicide screening tool, a revised version of the Risk of~     Suicide Questionnaire, to detect suicide risk in pediatric patients presenting to the CNMC ED~     for non-mental health reasons.~      Study population:~      The study population includes all patients admitted to the CNMC Emergency Department, ages 10~     to 21, during the data collection weeks of the study period. Both patients admitted for~     mental health and non-mental health reasons will be included in the study.~      Design:~      This will be a prospective instrument development /validation study. During a designated~     study week, all mental health patients and a random subset of non-mental health patients~     admitted to the CNMC ED will be approached after their triage assessment. Following informed~     consent and assent, a 17-item suicide assessment tool created for this research project~     (RSQ-Revised), as well as a brief background questionnaire will be administered. These~     questions will be validated against a gold standard suicide assessment questionnaire, which~     will be administered to the subjects directly after the RSQ-Revised. The study aims to~     develop a brief suicide screening tool to be used at triage for all patients entering the ED.~      Measures~      Measures include the proposed 17-item screening questionnaire and a gold standard assessment~     of suicidal ideation in adolescents, the Suicide Ideation Questionnaire (SIQ).~   "
224230|NCT00623480|"~     To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding~     frequency (number of bleeds per year) and on joint damage.~   "
224231|NCT00623467|"~     This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called~     Gadavist. The purpose of this study is to look at the safety (what are the side effects) and~     efficacy (how well does it work) of Gadavist when used for taking images of the brain and~     spine. The results of the MRI will be compared to the results of images taken without~     Gadavist.~   "
224232|NCT00623454|"~     All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or~     palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have~     symptoms of chest pain or palpitation. If they still have some of the symptoms they are~     invited to participate in a coping course to learn a better way to deal with their symptoms.~      The coping course consist of three sessions of cognitive behaviour therapy.~   "
224233|NCT00623441|"~     The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been~     assessed in a series of studies. The stent is coated with a proprietary drug compound that is~     designed to reduce restenosis.~      This prospective multi-center study has been initiated:~        -  To document the acute and mid-term safety and overall clinical performance of the stent~          system in a real world patient population requiring stent implantation.~        -  To assess the event rate in patient subgroups with specific clinical indications and/or~          vessel or lesion characteristics.~   "
224234|NCT00623428|"~     This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin~     combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C,~     genotype 2/3.~   "
224235|NCT00623415|"~     Flupirtine, a non-opioid analgesic drug, that has been shown to have additional~     neuroprotective functions, is given twice daily as an oral medication in patients with~     relapsing remitting multiple sclerosis over a period of 12 months. Neuroprotection is~     assessed by magnetic resonance imaging, magnetic resonance spectroscopy, optical coherence~     tomography, and clinical examination.~   "
224236|NCT00623402|"~     To evaluate the efficacy and safety of a combined treatment with Sorafenib (Nexavar®) and~     pegylated interferon-α-2b (PegIntron®) in patients with malignant melanoma in stage IV.~   "
224237|NCT00623389|"~     The purpose of this study is to evaluate a surgically implanted functional electrical~     stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people~     with various degrees of paralysis.~   "
224238|NCT00623376|"~     Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in~     people with spinal cord injury (SCI).~      Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover~     study. They received either nabilone or placebo during the first four-week period (0.5mg OD~     with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week~     washout, subjects were crossed-over to the opposite arm.~      The primary outcome was the Ashworth scale for spasticity in the most involved muscle group,~     chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale,~     Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle~     groups of each side of the body, and the Clinician's and Subject's Global Impression of~     Change .~   "
224239|NCT00623363|"~     The purpose of this study is to obtain preliminary information on the effect of piclozotan on~     motor complications associated with Parkinson's Disease.~   "
224240|NCT00623350|"~     Noninvasive prospective multi-center study of an interactive 2-way, wireless or~     site-independent, audiovisual telemedicine system designed for real-time remote examination~     of acute stroke symptoms and deficits as a basis for treatment consultation and~     recommendation.~      Study aims (1) to determine the impact of a site-independent, remote, telemedicine~     consultation system on decision making in the Emergency Department, regarding the decision to~     treat or not to treat with thrombolytics; (2) to assess the numbers of patients who receive~     thrombolytics and the time to treatment in patients evaluated by telemedicine versus~     telephone only; (3) to assess the appropriateness of thrombolytic treatment decisions in~     telemedicine versus telephone-only consultations; and (4) to assess the completeness of the~     data collection in telemedicine versus telephone-only consultations.~      60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner~     discretion (onset generally less than 12 hours and likely less than 3 hours)~      Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only~     (Control n = 30)~   "
224267|NCT00622986|"~     This study is designed to determine whether an extract of Cimicifuga Foetida L. is safe and~     efficacious to relieve the climacteric symptoms of Chinese women~   "
224268|NCT00622973|"~     Preoperative detection of lymph node metastases in patients with prostate or bladder cancer~     is crucial for selection of the appropriate treatment strategy (surgery, androgen deprivation~     with/or without radiation therapy or chemotherapy) and thus for patient prognosis. Until now~     CT or MRI have been the modalities of choice for preoperative staging procedures. However,~     current morphological assessment of lymph nodes based on size and shape is unable to detect~     smaller metastases or liable to give false positive results on lymph nodes with reactive~     hyperplasia. We hypothesize that USPIO-enhanced MRI combined with DW-MRI will be able to~     detect pelvic lymph node metastases preoperatively with high sensitivity and specificity.~   "
224241|NCT00623337|"~     Introduction: Just under four million infants die each year before reaching one month of age;~     neonatal deaths now account for 38% of the 10.8 million deaths among children younger than 5~     years of age. Tackling neonatal mortality is essential if the millennium development goal to~     reduce by 2015 overall child mortality by two-thirds from its levels in 1990 is to be~     achieved. Postnatal care for mothers and neonates in developing countries, particularly when~     deliveries occur at home, is either not available or is of poor quality. Trained community~     workers are considered by many to be pivotal to newborn care in the community, as they can~     act as catalysts for community actions and also be providers of care.Reductions in neonatal~     mortality have been slower in Sub-Saharan Africa than in any other region, and no evaluations~     of the effectiveness and feasibility of home visits in reducing neonatal mortality have been~     conducted.~      Trial aim: To link with the Ghana Health Service to develop a feasible and sustainable~     intervention to improve newborn care practices and careseeking during pregnancy and~     childbirth, and to identify and refer very low birth weight and/or sick babies, through~     routine home-visits by community health workers (CHWs), and by so doing reduce neonatal~     mortality.~   "
224242|NCT00623324|"~     The purpose of this study is to demonstrate the safety, tolerability, efficacy and~     pharmacokinetics of aplindore in patients with early stage Parkinson's Disease (PD) who are~     not currently taking any dopamine agonists or who are able to wash off dopamine agonists for~     14 days prior to baseline. Efficacy will be assessed using the UPDRS questionnaire including~     part 3 of the UPDRS (Motor). their level of sleepiness on a standardized rating scale~     (Epworth Sleepiness Scale) and their level of nausea daily.~      Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs~     (blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and~     self rated scales.~   "
224243|NCT00623298|"~     The present study is a pragmatic trial that investigates the efficacy and usefulness of two~     treatment modules in a sample of Rwandan genocide orphans: Narrative Exposure Therapy (NET)~     versus group-Interpersonal Psychotherapy (IPT). We used a half year baseline to measure the~     treatment-induced changes. We hypothesized that there would be a greater reduction in~     posttraumatic stress symptoms in the NET- than in the IPT-group and that IPT would be~     superior to NET in the reduction of depression symptoms.~   "
224244|NCT00623285|"~     We hypothesize that the perioperative administration of pregabalin will significantly~     decrease pain scores and post-operative opioid requirements for patients undergoing coronary~     artery bypass grafting, and reduces the incidence of opioid-induced side effects such as~     respiratory depression. This may reduce ICU admission and possibly abbreviate length of~     hospital stay.~   "
224245|NCT00623272|"~     compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after~     a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular~     dysfunction~   "
224246|NCT00623259|"~     Monocentric study to assess the safety and immunogenicity of the recombinant MVA-HIV~     multiantigen vaccine MVA-mBN120B in HIV-infected subjects. 15 subjects will receive~     immunizations at day 0, after 4 and 12 weeks at a dose of 2E8 TCID50 MVA-mBN120B. The vaccine~     will be administered subcutaneously.~   "
224247|NCT00623246|"~     Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops~     breathing or experiences shallow breathing for short periods of time during sleep. The most~     common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine,~     but many people have trouble adhering to the treatment schedule. This study will evaluate the~     effectiveness of two behavioral therapy programs used in combination with CPAP for improving~     treatment adherence in people with OSA.~   "
224248|NCT00623233|"~     To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in~     patients with advanced breast cancer.~   "
224249|NCT00623220|"~     The primary objective of the proposed study is to show that inhaled equimolar mixture of~     oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm~     infant, as compared to the current standard treatment (oral sucrose and topical anaesthesia).~      The investigators also aim to show that EMONO can be used safely in preterm neonates~     undergoing retinal exam, and will not result in any increase in apnea, bradycardia, or~     desaturation in the 24 hours following the exam. Finally, the investigators aim to show that~     EMONO will keep the infant calm, and make retinal examination easier and less traumatic.~   "
224250|NCT00623207|"~     The aim of this study is to evaluate the Safety and feasibility of atropine added during~     treadmill stress testing in patients with chronotropic incompetence or poor exercise~     capacity.~      Our hypothesis is that we can increase heart rate by using atropin in these patients, so we~     will achieve more conclusive results.~   "
224251|NCT00623194|"~     This trial is conducted in Europe. The aim of this research is to assess the safety of~     continuous treatment with insulin detemir following participation in trial NN304-1689~     (NCT00435019) on antibody development.~   "
224252|NCT00623181|"~     To describe any degree of preference for the route of administration of Fluzone influenza~     vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.~      To collect safety data, injection site reactions, and systemic reactions, through Day 7~     post-vaccination; SAEs through day 28 post-vaccination~   "
224253|NCT00623168|"~     Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by a virus acquired by contact with~     chronically infected rodent hosts. HFRS is present throughout Korea. Treatment consists~     mainly of supportive care with careful attention to control of blood pressure and fluid~     balance and/or dialysis. Early initiation of IND Intravenous Ribavirin has been shown to be~     an effective treatment for HFRS and may prevent the need for dialysis. It is important to~     initiate therapy based on a diagnosis consistent with HFRS and a history that makes exposure~     likely. This study will monitor the clinical events that occur with HFRS as well as the~     safety and efficacy of Ribavirin.~   "
224269|NCT00622960|"~     The purpose of this proposed randomized, controlled trial is to compare the effects of high~     monounsaturated fat diets and high carbohydrate diets on body weight, body composition,~     glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one~     year. At present, no such studies of free-living subjects have been performed. The specific~     aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat~     diet will produce greater weight loss/body fat loss and more successful weight maintenance~     than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an~     improved lipid profile and better glycemic control than a high carbohydrate diet.~   "
224254|NCT00623155|"~     Recent, randomized controlled trials conducted in areas of perennial malaria transmission~     have shown that intermittent preventive treatment (IPT) given at the time of vaccination~     reduced the incidence of the first episode of malaria and severe anaemia during the first~     year of life by more than 50% without there being any rebound in the subsequent year.~     However, in countries such as Mali, where malaria is highly seasonal and prevalent in older~     children, IPT in infants may not be the optimum way in which to use antimalarial drugs to~     prevent malaria. An alternative approach is to give intermittent preventive treatment to~     children at risk just during the rainy season. Here we propose (i) to evaluate the impact of~     two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the~     incidence of malaria disease in children of 6 months to 10 years in an area of seasonal~     transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo~     response of P. falciparum to SP; (iii) to assess the potential rebound effect of this~     strategy on the subsequent transmission season after the cessation. Children 6 months-10~     years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks~     interval or no IPT during the transmission season and will followed up for 12 months.~     Subjects will be also followed during the subsequent transmission season to assess possible~     rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to~     assess the in vivo response during both periods.~   "
224255|NCT00623142|"~     The purpose of this study was to determine if treating patients who have coronary heart~     disease with hyperbaric oxygen (HBO) prior to coronary artery bypass graft (CABG) surgery~     reduces injury to the heart and vascular system during and after surgery. Furthermore, this~     study also aims to identify some of the post CABG clinical effects of HBO treatment prior to~     CABG.~   "
224256|NCT00623129|"~     RATIONALE: Electroacupuncture may help relieve chronic dry mouth caused by radiation therapy.~     It is not yet known whether electroacupuncture is more effective than a placebo in treating~     chronic dry mouth caused by radiation therapy in patients with head and neck cancer.~      PURPOSE: This randomized clinical trial is studying electroacupuncture to see how well it~     works compared with a placebo in treating chronic dry mouth caused by radiation therapy in~     patients with head and neck cancer.~   "
224257|NCT00623116|"~     Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome~     in Finland.~   "
224258|NCT00623103|"~     The purpose of this study is to provide long-term safety data for rivastigmine capsule and~     transdermal patch treatments, in particular the effect of rivastigmine on worsening of the~     underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately~     severe dementia associated with PD.~   "
224259|NCT00623090|"~     Prostate cancer (PCa) is the leading cancer diagnosis among men and the second leading cause~     of male cancer death. However, screening asymptomatic men remains controversial, as early~     diagnosis and treatment of PCa has not yet demonstrated reduced disease-related mortality in~     a randomized trial. The goal of the current study is to develop and assess widely accessible~     methods to assist men in making informed decisions about PCa screening. We will compare the~     efficacy of a new web-based, interactive decision support approach to our existing~     print-based PCa screening decision tool, among a diverse sample of male primary care~     patients. Abundant evidence documents the expanding role of the Internet in increasing access~     to and understanding of health information and the need for systematic evaluations of~     Internet-based interventions. A novel aspect of the proposed trial will be our focus on~     cognitive biases as a factor that has limited the success of previous information-based~     interventions. Specifically, we will evaluate: 1) confirmation bias and 2) short-term~     consequences bias.~   "
224260|NCT00623077|"~     RATIONALE: A peripheral blood stem cell transplant or bone marrow transplant using stem cells~     from the patient may be able to replace immune cells that were destroyed by chemotherapy and~     image-guided intensity-modulated radiation therapy used to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bone marrow~     radiation therapy followed by an autologous stem cell transplant in treating patients with~     high-risk or relapsed solid tumors.~   "
224261|NCT00623064|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, and gemcitabine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving lapatinib together with combination chemotherapy may kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when~     given together with cisplatin and gemcitabine as first-line therapy in treating patients with~     locally advanced or metastatic urothelial cancer.~   "
224262|NCT00623051|"~     This study is aimed at demonstrating whether or not Male Circumcision can be used as an~     effective public health prevention tool that will have an impact on HIV prevalence in the~     South African population.~   "
224263|NCT00623038|"~     It is of importance to predict the risk to develop problems after birth. Virginia Apgar~     developed a score more than 50 years ago that allows a description of the condition of~     newborns at 1, 5 and 10 minutes after birth. The Apgar score is used for every newborn,~     however, its applicability is restricted in preterm infants and resuscitated newborns. Thus,~     two scores have been suggested recently - the Specified Apgar and the Expanded-Apgar score.~     By combining both scores the Combined-Apgar has been developed as a new delivery room tool.~      The purpose of this study is to determine whether the Combined-Apgar predicts poor outcome~     better than the Specified- or Expanded Apgar alone.~   "
224264|NCT00623025|"~     The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.~   "
224265|NCT00623012|"~     The objective of this study is to evaluate feasibility, toxicity and efficacy of using~     Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus~     taper in recipients of allogeneic stem cell transplant.~      Our hypothesis is that the T cells that can cause chronic GVHD are suppressed but not~     eliminated by calcineurin inhibitors. Therefore, when the calcineurin inhibitors are~     discontinued, the T cells may get activated and result in GVHD. Rapamycin on the other hand~     will allow anergy formation and thus when discontinued, T cells should not get activated. The~     schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued.~     Rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in~     two weeks.~   "
224272|NCT00622921|"~     Purpose: Phase I focus groups with clinicians and patients will gather qualitative data to~     focus and inform the content of Phase II. In Phase II, 12 weeks of psychotherapy will be~     offered to evaluate feasibility and potential efficacy of a couples-based, integrated~     treatment for men with PTSD and alcohol dependence.~      Hypotheses: We predict that this experimental psychotherapy, Partners Encouraging Abstinence~     and Coping with Emotions (PEACE), will reduce patient drinking, reduce PTSD symptoms, and~     improve relationship functioning.~   "
224273|NCT00622908|"~     To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day~     (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of~     bacterial conjunctivitis~   "
224274|NCT00622895|"~     The purpose of the study is to examine the safety and effectiveness of a reduced intensity~     conditioning regimen and allogeneic bone marrow transplant for people with systemic~     sclerosis. In an allogeneic bone marrow transplant procedure, bone marrow is taken from a~     healthy donor and transplanted into the patient. Bone marrow can be donated by a family~     member or an unrelated donor who is a complete tissue type match.~      Participants will receive the chemotherapy and low dose radiation conditioning regimen~     consisting of the following: Fludarabine will be given intravenously for 5 days.~     Cyclophosphamide will be given intravenously on the first and second day. After completing~     the fludarabine and cyclophosphamide, patients will receive a single low dose of total body~     irradiation. The next day, patients will receive the allogeneic bone marrow transplant. On~     the third and fourth day after the transplant, patients will receive high dose intravenous~     cyclophosphamide. This is given to help prevent two complications: (1) graft rejection, which~     occurs when the body's immune system rejects the donor bone marrow, and (2) graft-versus-host~     disease (GVHD), which is when the donor immune cells attack the patient's normal tissues. On~     the fifth day after the transplant, patients will start receiving two additional medications:~     tacrolimus and mycophenolic acid (MPA, Myfortic), to help prevent GVHD. Patients will receive~     mycophenolic acid for about 5 weeks and tacrolimus for about 6 months. Also beginning on the~     fifth day after the transplant, patients will receive daily injections of a growth factor~     called granulocyte-colony stimulating factor (G-CSF), which is a protein that increases the~     white blood cell count; G-CSF will be continued until the patient's white blood cell count~     has returned to normal levels.~      Patients will remain closely monitored either in the outpatient clinic setting or in the~     hospital for approximately 2-3 months after the transplant, but possibly longer if there are~     complications. Follow-up study visits will occur at 6 months and then at 1, 2, 3, 4, and 5~     years after the transplant. Study researchers will keep track of the patient's medical~     condition after leaving the transplant center by phone calls or mailings to patients and~     their doctors once a year for the rest of the study participants' lives.~   "
224275|NCT00622882|"~     The primary objective is to determine if early infectious disease (ID) consultation (defined~     as within 48 hours of a positive blood culture) will reduce mortality rates from~     Staphylococcus aureus bacteremia (SAB). This study will also determine if such consultations~     could reduce the duration of hospitalisation, recurrence and financial costs in patients with~     this infection.~   "
224276|NCT00622869|"~     This trial was designed to address important issues that impact recipients of liver~     allografts as well as clinicians, ie, renal function, reduction or discontinuation of~     tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus~     (HCV) positive patients.~   "
224277|NCT00622856|"~     A three arms, open, randomized interventional study including 100 participants in order to~     evaluate the cost-efficacy of psychological intervention for strengthening parental authority~     among parents of diabetic adolescents with poor glycemic control.~      All participants will be randomized into three groups:1.The first group will get a~     psychological treatment in order to strengthen the parent's authority. 2.The second group~     will get an education of a nurse and a dietician. 3.The third group will serve as a control~     group and will not go through an intervention.~      The following data will be analyzed during the study: 1.Changes in HbA1c. 2.Changes in~     parents authority. 3.Changes in the diabetes treatment by the adolescents. 4.Consumption of~     health services. 5.The costs of all psychological treatments.~   "
224278|NCT00622843|"~     Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine~     (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a~     significantly better immunologic response to boosting can be elicited in patients previously~     vaccinated with PPV.~   "
224279|NCT00622830|"~     This study is being conducted to provide safety, tolerability, PK and PD data in repeat~     dosing that will allow further studies with darapladib in Japanese patients~   "
224280|NCT00622817|"~     This was a randomized, double blinded, controlled trial. The aim of the study was to compare~     xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis.~      The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine~     inhalation for treatment of bronchiolitis.~      Signed informed consent was obtained from a parent of each child. And the human ethics~     committee of our hospital approved the study according to the principles of the Declaration~     of Helsinki.(Approved - 2002)~      Patients:~      65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider~     Children's Medical Center because of bronchiolitis during winter in two consecutive years~     2004-2005.~      The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after~     informed consent was signed with clinical presentation of mild to moderate bronchiolitis~     according to a clinical score .Exclusion criteria were as follows: prematurity, congenital~     lung or cardiac disease, infants who had past hospitalization due to respiratory illness and~     severe bronchiolitis (score>7 with a range scale 0-10).~   "
224281|NCT00622804|"~     The purpose of this study is to evaluate the degree of bile reflux and gastric stasis~     according the reconstruction methods after distal subtotal gastrectomy for gastric cancer,~     and to find out the proper method. We collect ninety patients who undergo distal gastrectomy~     for gastric cancers for this study from 5 institutions and randomly divide into 3 groups~     according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy~     (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).~   "
224282|NCT00622791|"~     Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to~     several drugs, including propofol. Few studies, however, have tested if propofol~     pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic~     effect of propofol after CPB. This study was designed to test the hypothesis that changes in~     the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced~     by changes in bispectral index (BIS) values.~      Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1)~     CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood~     samples for plasma propofol concentration measurements will be collected along the surgery~     and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral~     index values and propofol PK will be compared between the groups.~   "
224283|NCT00622778|"~     The purpose of this study is to try to prove the worth of the two (2) Serum Proteins S-100~     Beta and NSE in combination with a diagnostic algorithm to help to establish diagnosis in~     patients with minor head injury.~   "
224284|NCT00622765|"~     This study investigates the effectiveness and safety of 12 weeks of treatment with~     JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of~     effectiveness is the change in body weight at a clinically relevant dosage level during~     treatment. Additional measures include body mass index (BMI), DEXA (dual X-ray absorptiometry~     which is a specialized x-ray test that measures body composition), fasting glucose, lipid~     levels, and blood pressure. Safety assessments performed during the trial include laboratory~     tests, vital sign measurements, and adverse event reporting.~   "
224285|NCT00622752|"~     This randomised, placebo-controlled study is designed to explore the effects of EVT 302 both~     with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in~     smokers after short term deprivation of cigarettes.~   "
224286|NCT00622739|"~     This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to~     determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric~     bipolar disorder (PBD). In this pilot study we are comparing the efficacy of rapid versus~     slow dose titration of ziprasidone in PBD. The investigators hypothesize that subjects on~     ziprasidone monotherapy will have a reduction in manic symptoms. Also, the investigators~     hypothesize that slower titration of ziprasidone will result in lesser side effects which~     will assist in medication compliance as measured by patient report and pill count.~   "
224287|NCT00622726|"~     The purpose of this study was to determine the efficacy and additional advantages of~     intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.~   "
224288|NCT00622713|"~     This study is designed to confirm the efficacy, the tolerability, the patient compliance and~     the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with~     probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting~   "
224289|NCT00622700|"~     The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram~     per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of~     participants presenting with their first clinical episode consistent with multiple sclerosis~     (MS) to clinically definite multiple sclerosis (CDMS).~      The secondary objectives were:~        -  To demonstrate the effect of teriflunomide, in comparison to placebo, on:~             -  Reducing conversion to definite multiple sclerosis (DMS)~             -  Reducing annualized relapse rate (ARR)~             -  Reducing disease activity/progression as measured by Magnetic Resonance Imaging~               (MRI)~             -  Reducing accumulation of disability for at least 12 weeks as measured by the~               Expanded Disability Status Scale (EDSS)~             -  Proportion of disability-free participants as assessed by the EDSS~             -  Reducing participant-reported fatigue~        -  To evaluate the safety and tolerability of teriflunomide~        -  To evaluate the pharmacokinetics (PK) of teriflunomide~        -  Optional pharmacogenomic testing aimed at assessing the association between the main~          enzyme systems of teriflunomide metabolism and hepatic safety, and other potential~          associations between gene variations and clinical outcomes~   "
224290|NCT00622687|"~     This study compared the efficacy of different dosages of long-term iloprost treatment on~     Raynaud's phenomenon, ulcer healing, skin thickening, and progression of internal organ~     sclerosis in systemic sclerosis (SSc).~      Methods. 50 SSc patients were 1:1 randomised either for maximally tolerated dose up to 2~     ng/kg body weight [bw] per minute or low dose (0.5 ng/kg bw per minute) intravenous iloprost~     administration, for six hours daily over 21 days. The effect on RP, ulcer healing, skin~     thickness, oesophagus function, lung involvement as assessed by lung function parameters FVC~     and DLCO, and side effects were measured.~      Conclusions. The efficacy of prolonged administration of iloprost is also achieved with low~     dose iloprost by long term treatment. The effects suggest a disease-modifying capability of~     iloprost, but further studies are needed to proof this hypothesis.~   "
224291|NCT00622674|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Giving bortezomib~     together with cetuximab may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with cetuximab in treating patients with advanced solid tumors.~   "
224292|NCT00622661|"~     This study is designed to investigate associations of low- and high-glycemic load diets with~     biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for~     cancer risk.~   "
224293|NCT00622648|"~     The primary objective:~        -  To demonstrate in patients hospitalized for an acute medical illness that enoxaparin~          with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated~          Elastic Stockings on overall mortality at day 30 after randomization.~      The secondary objective:~        -  To compare, in patients hospitalized for an acute medical illness, enoxaparin with~          Graduated Elastic Stockings versus enoxaparin placebo with Graduated Elastic Stockings~          on overall mortality at day 90 after randomization.~        -  To evaluate the safety of enoxaparin VTE prophylaxis in patients hospitalized for acute~          medical illness with respect to major hemorrhage, total bleedings, heparin induced~          thrombocytopenia, adverse events and serious adverse events .~   "
224294|NCT00622635|"~     This study was conducted to provide detailed information on the efficacy of indacaterol in~     terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a~     24 hour time period.~   "
224295|NCT00622622|"~     The purpose of this study is to evaluate the safety, tolerability and immune response of~     different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with~     gemcitabine and to determine the recommended phase II dose.~   "
224296|NCT00622609|"~     GSK249320 is a monoclonal antibody directed against myelin associated glycoprotein (MAG), a~     protein that inhibits axonal regeneration. GSK249320 acts as a MAG antagonist, and through~     this activity it is hypothesised that it will enhance recovery from neuronal degeneration~     following acute axonal injury, which occurs in spinal cord injury or stroke.~   "
224297|NCT00622596|"~     The purpose of this study was to expand access to buprenorphine using a mobile health care~     system among marginalized populations with or at high risk for HIV and observe longitudinal~     effects of treatment.~   "
224298|NCT00622583|"~     To determine patient reported long-term outcomes, and post-implantation clinical~     characteristics related to the use of mesh products in 3,500 patients minimum.~   "
224299|NCT00622570|"~     Objective: to assess the effectiveness of pentobarbital and thiopental to control raised~     intracranial pressure (ICP), refractory to first level measures, in patients with severe~     traumatic brain injury.~      Material and methods: prospective, randomized open study to compare the effectiveness between~     two treatments: pentobarbital and thiopental. The patients will be selected from those~     admitted to the Intensive Care Unit with a severe traumatic brain injury (postresuscitation~     Glasgow Coma Scale equal or less than 8 points) and raised ICP (ICP>20 mmHg) refractory to~     first level measures according to the Brain Trauma Foundation guidelines. The adverse effects~     of both treatments were also collected.~   "
224300|NCT00622557|"~     A database has been established to track the outcomes of all cases performed in the~     University Hospitals Department of Surgery in an effort to improve quality of surgical~     performance and case management.~      Specifically, the purpose of the database will be used as a quality improvement tool for~     analyzing process and outcome measures and to accurately track cases performed by surgeons.~   "
224301|NCT00622544|"~     The goal of the Microalbuminuria in Untreated Boys with Alport Syndrome study is to gather~     information about critical clinical time points such as when patients with small amounts of~     protein (microalbuminuria) in their urine progress to larger amounts (overt proteinuria).~     Large amounts of protein in the urine is often an early sign of kidney disease.~      Information needs to be collected in boys who are not taking medications known as angiotensin~     converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in order to obtain~     accurate data about the length of time between the onset of microalbuminuria and the start of~     overt proteinuria. This new information will give physicians a better understanding of how to~     treat patients with Alport syndrome.~      The information we gather by conducting this study will aid in planning future clinical~     trials because the identification of time points in disease progression, such as~     microalbuminuria and overt proteinuria, could reduce the time necessary to show a clinical~     benefit of a new treatment option.~      The study has been approved by the University of Minnesota's Institutional Review Board.~   "
224302|NCT00622531|"~     The scope of the USE-BNP Trial is to investigate whether knowledge of BNP measurements, in~     conjunction with clinical assessment, in the outpatient setting can guide the management of~     therapy in patients with heart failure.~   "
224303|NCT00622518|"~     The purpose of this study is to determine if a commercially available homeopathic ear drop~     preparation is effective in reducing symptoms in children 6 months - 11 years old with acute~     otitis media. A total of 120 study patients with otitis media will be randomized to receive~     homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is~     postulated that children using the ear drops will have more rapid resolution of symptoms and~     need fewer antibiotics than those randomized to not receive the ear drops.~   "
224304|NCT00622505|"~     This study will evaluate the effectiveness and safety of a dosing method for zoledronic acid~     in preventing skeletal complications in multiple myeloma patients who have been on an IV~     bisphosphonate for about one to two years.~   "
224305|NCT00622492|"~     Rationale: Persistent pulmonary hypertension of the newborn (PPHN) is a life threatening~     disease with a high mortality rate. Extracorporeal Membrane Oxygenation (ECMO) with~     veno-arterial (V-A) or veno-venous (V-V) cannulation can provide a last treatment option.~     Differences in circulatory changes between V-A and V-V ECMO concerning the course of PPHN and~     organ perfusion are not known. Independent of the underlying disease, courses of ECMO runs~     (with both systems) may differ a lot. Impairment of pulmonary and renal function and oedema~     is frequently seen. Mechanisms that may play a role are not well understood yet. A better~     understanding of hemodynamic changes in systemic and pulmonary circulation during treatment~     of PPHN with ECMO as well as consecutive changes in organ perfusion and function will help to~     develop more rationalistic treatment strategies to accelerate the recovery to a normal~     neonatal circulation and shorten ECMO treatment. This will reveal positive effects for~     patients as well as favourable effects on economic aspects for this very intensive treatment.~      Primary objective: I.Evaluation of changes in pulmonary and systemic circulation during VV-~     ECMO treatment and difference between V-V- and V-A ECMO Secondary objectives:II.Evaluation of~     changes in cerebral, renal and mesenterial organ perfusion during ECMO treatment and~     difference between V-V- and V-A ECMO III.Evaluation of hemodynamic changes during ECMO~     treatment in relation to renal function and difference between V-V- and V-A ECMO~     IV.Evaluation of BNP as diagnostic parameter regarding fluid homeostasis during ECMO~     treatment and difference between V-V- and V-A ECMO Study design: observational; including two~     cohorts. The first cohort consists of a group of patients that have been evaluated in a~     former study, exclusively treated with V-A ECMO. The second cohort of patients will~     prospectively include patients receiving V-V as well as V-A ECMO. A study period:2 and a half~     years. All consecutively admitted patients for ECMO treatment at the department of~     neonatology of the RUNMC will be evaluated for inclusion into the study. Study population:~     Inclusion: Newborn infants with gestational age older than 34 weeks and reversible causes of~     PPHN eligible for ECMO treatment. Exclusion:Newborn infants with congenital diaphragmatic~     hernia, other congenital malformations and post-cardiosurgery.~      Intervention: Standard treatment following the ECMO protocol of the department; evaluation at~     standard intervals starting directly before cannulation for ECMO until 24 hours after~     decannulation:registration of hemodynamic variables,parameters for organ perfusion using~     echocardiography and Doppler sonography, blood and urine sampling and registration of~     physiological and patient data.~      Main study parameters/endpoints: Assessment of:Hemodynamic changes in pulmonary and systemic~     circulation Secondary and other parameters/endpoints:~      Assessment of:Changes in cerebral, renal and mesenterial blood flow, renal function in~     relation hemodynamic changes,BNP in relation to fluid homeostasis~   "
224306|NCT00622479|"~     The purpose of this study is to:~        1. To elucidate the mechanism involved in the sorafenib-induced hypophosphatemia and~          possible early effect of hypophosphatemia on bone mineral density~        2. A secondary objective to assess the effect sorafenib treatment on evaluate left~          ventricular function (LVEF) and Beta-type natriuretic peptide in plasma.~   "
224307|NCT00622466|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as paclitaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving sorafenib together with~     paclitaxel may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with~     paclitaxel and to how well it works in treating patients with metastatic breast cancer.~   "
224308|NCT00622453|"~     Adult myotonic muscular dystrophy (Steinert's disease) is the most common inherited~     neuromuscular disorder. Cardiac rhythm disturbances occur frequently in this disease state~     and may be responsible for up to one-third of deaths. In this study, we intend to evaluate~     the utility of non-invasive electrocardiographic screening methods and history in predicting~     serious arrhythmic events.~   "
224309|NCT00622440|"~     The purpose of this study is to find out if a Chinese herbal cream is effective in treating~     HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal~     intraepithelial neoplasia).~   "
224310|NCT00622427|"~     Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset~     and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to~     placebo. Secondary:We expect that Ramelteon will show statistically significant improvements~     vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning,~     including such specific items as focus and social and occupational functioning.~   "
224312|NCT00622401|"~     The purpose of this study is to test the safety of an investigational Dendritic Cell/Tumor~     Fusion vaccine given with IL-12 for patients with breast cancer.~      RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body~     build an effective immune response to kill tumor cells. Interleukin-12 may stimulate the~     white blood cells to kill tumor cells. Giving vaccine therapy together with interleukin-12~     may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-12~     when given together with vaccine therapy and to see how well they work in treating women with~     stage IV breast cancer.~   "
224313|NCT00622388|"~     The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused~     Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous~     transplant~   "
224314|NCT00622375|"~     The current study is being conducted to evaluate the relative bioavailability and single- and~     multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy subjects.~   "
224315|NCT00622362|"~     The objective of this trial is to evaluate the clinical effectiveness of the administration~     of a depigmented and polymerized allergen extract Dermatophagoides pteronyssinus in children~     with allergic asthma due to this mite~   "
224316|NCT00622349|"~     The purpose of this study is to determine if cisplatin-based chemotherapy,~     cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison~     to the combination gemcitabine-ifosfamide in patients with advanced NSCLC~   "
224317|NCT00622336|"~     The study evaluated the safety of Lenalidomide monotherapy in participants with advanced~     multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose~     dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and~     CC-5013-MM-010 due to the development of documented disease progression or the inability to~     tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose~     dexamethasone without grade 3 or 4 toxicity.~   "
224318|NCT00622323|"~     This is a prospective, non-interventional, post marketing surveillance study to determine the~     proportion of patients experiencing an adverse event and a list of the experienced adverse~     events, serious and non-serious, that would occur among Filipino patients with type 2~     diabetes mellitus who are treated with exenatide who are taking metformin, a sulfonylurea or~     a combination of metformin and a sulfonylurea but have not achieved adequate glycemic~     control.~   "
224319|NCT00622310|"~     This project is aimed at determining whether an exercise-based weight loss intervention~     causes a compensation in some component of energy expenditure such that the increase in~     measured energy expenditure is less than the added exercise. The study will compare two~     separate exercise interventions to determine if this is influenced by exercise intensity.~   "
224320|NCT00622284|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to~     preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient~     glycaemic control~   "
224321|NCT00622271|"~     The purpose of this study is to utilize a group therapy adjustment and coping program at the~     Children's Hospital of Wisconsin with patients who have Type 1 Diabetes Mellitus (T1DM) and~     their parents within a typical clinical condition of patients who have been referred for~     outpatient therapy services. To extend the previous literature on these types of peer and~     family-based groups to include survey data as well as provider ratings, medical data, and add~     retrospective and prospective data from baseline enrollment. To aid in establishing this~     group therapy methodology as a promising evidence-based intervention within a population of~     youths with T1DM and their families. The specific aim of this project is to enroll patients~     and their families into either a treatment group or a wait list control group to receive the~     group intervention to determine the impact of this peer and family-based group on improving~     adjustment, coping, and functioning within diabetes.~   "
224322|NCT00622258|"~     This study assesses the tolerability, safety, efficacy and pharmacokinetics of everolimus in~     Japanese patients. Everolimus is administered orally everyday to adult patients with relapsed~     or refractory non-Hodgkin's lymphoma who have progressed despite standard therapy or for whom~     standard systemic therapy dose not exist.~   "
224323|NCT00622245|"~     This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the~     treatment of depression in patients with bipolar disorder.~   "
224324|NCT00622232|"~     The objective of this study is to determine the long term safety and tolerability of an~     additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating~     additional therapeutic benefits with respect to viral load and CD4 counts.~   "
224325|NCT00622219|"~     The goal of this project is to determine the barriers to, and risks and benefits of random~     laboratory drug testing for adolescents with identified drug or alcohol problems.~   "
224326|NCT00622206|"~     Compare the Pharmacokinetics of ritonavir and saquinavir(using either Saquinavir /Ritonavir~     1500/100 mg or 1500/50 mg) Evaluate short term tolerability, safety and toxicity Evaluate if~     there is any relation between RTV concentration levels and boosting effect~   "
224327|NCT00622193|"~     The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in~     patients with non-small cell lung cancer.~   "
224328|NCT00622180|"~     To assess over a 25-week period the efficacy of hand-foot narrow-band ultraviolet B light~     versus focal 308-nm light treatment in inducing the return of pigment in vitiligo after skin~     minigraft transplants to the backs of the hands in patients with light brown to black skin.~     Subject will undergo treatment for 13 weeks.~   "
224329|NCT00622167|"~     The purpose of this study is to compare different methods of looking at atherosclerotic~     plaques in heart arteries. Identifying the characteristics of these plaques noninvasively~     would be very valuable. This study is looking at a new CT scanner (DSCT) to noninvasively~     image these plaques compared to invasive ultrasound (the current standard).~   "
224330|NCT00622141|"~     The previous two studies of generic GPO saquinavir failed to prove bioequivalence. In this~     study the bio-equivalence will be investigated in healthy Thai volunteers, to see whether the~     generic GPO saquinavir shows bioequivalence when boosted with Norvir®. If the generic~     formulation is bioequivalent subsequent studies may follow in HIV-1 positive patients.~   "
224332|NCT00622115|"~     Primary objective:~        -  to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous~          bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg~          (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations~          of enoxaparin in Caucasian healthy subjects.~      Secondary objective(s):~        -  to compare the pharmacokinetic and the pharmacodynamic profile between 3 different~          timing of administration of the UFH~        -  to assess the tolerability of the different anticoagulation protocols~   "
224333|NCT00622102|"~     We are performing a research study to learn more about the control of an individual's blood~     thinning (anticoagulation) on warfarin. Individuals from an anticoagulation clinic are being~     asked to participate in order to see if a lottery which provides the opportunity to win money~     in combination with the use of the Med-eMonitor might be useful in helping patients to~     achieve better control of their anticoagulation therapy. Half of the participants will be~     enrolled in the lottery arm and the other half will be a control group who will receive the~     Med-eMonitor only.~   "
224334|NCT00622089|"~     DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the~     ketoconazole molecule for the treatment of elevated blood glucose associated with type 2~     diabetes mellitus. Ketoconazole (Nizoral®) is a drug available by prescription for the~     treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower~     blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated~     cortisol may contribute to the development of type 2 diabetes.~   "
224335|NCT00622076|"~     Randomised controled multicenter trial about the appropriate length of postoperative~     catheterization after anterior colporrhaphy. Patients are included at the moment that they~     are planned for surgery and are allocated to one of the study arms after the operation in the~     recovery by a digital randomisation-procedure. 230 patients will be enrolled in the study and~     half of the patients will have a catheter during five days postoperatively and the other half~     will be catheterized only during two days. Main outcome measurements regards replacement of a~     catheter because of bladder retention and the occurence of cystitis.~   "
224336|NCT00622063|"~     To provide ongoing treatment with ARQ 501 for patients who have benefited from prior~     treatment with ARQ 501~   "
224337|NCT00622050|"~     The specific objectives of this project are to:~        1. Investigate the effects of reducing TV viewing time on energy intake, eating behavior,~          and energy expenditure in overweight or obese adult subjects, thus providing a basis for~          evaluating if reducing TV viewing time might be a useful adjunct therapy in obesity~          prevention and treatment~        2. Analyze the types of foods eaten in conjunction with TV viewing~        3. Determine if there is an association between location of TV and BMI.~   "
224338|NCT00622037|"~     To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in~     mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be~     assessed in this month long trial.~   "
224339|NCT00622024|"~     Postoperative arrhythmias (heart irregularities) are one of the most common complications~     after cardiac surgery and are associated with increased morbidity and mortality. Preoperative~     depression may be an important co-factor in the generation of postoperative arrhythmias due~     to sympathetic hyperactivity evident in patients with depression.~      Objectives: To determine the effect of preoperative depression on postoperative arrhythmia in~     patients undergoing elective coronary artery bypass graft (CABG) surgery.~      Prospective observational study, 120 patients undergoing elective CABG surgery ECG will be~     preformed preoperatively on all patients. All patients will be assessed for signs of~     depression using the Prime MD Patient Health Questionnaire (Prime MD PHQ) one week before~     surgery and 6 weeks postoperatively.Based on the Prime MD PHQ results, patients will be~     divided into two groups: those with or without signs of depression. Heart rate and rhythm~     monitoring with Holter will be performed for 3 days postoperatively in order to compare the~     incidence of postoperative arrhythmias between groups.~      The primary outcome is the number of patients with and without depression suffering from~     ventricular and/or supraventricular arrhythmias. Secondary outcomes include all cause~     mortality, non-fatal myocardial infarction, cardiac arrest, and congestive heart failure.~      CABG surgery is the most common operative procedure in North America and arrhythmias are one~     of the most common postoperative complication. It is estimated that about a third of these~     cardiac patients suffer from preoperative depression and therefore may be exposed to a higher~     risk of perioperative morbidity and mortality. If an association between preoperative~     depression and postoperative arrhythmia is found, treatment modalities may be indicated to~     reduce the prevalence of perioperative arrhythmia in patients with preoperative depression~     undergoing cardiac surgery.~   "
224340|NCT00622011|"~     Delirium is an organic psychiatric syndrome characterized by fluctuating consciousness and~     impairment in perception, cognition and behavior. In hospitalized elderly, the prevalence of~     delirium ranges from 10% to 40%. If untreated, delirium is associated with significant~     morbidity and mortality. Treatment of delirium consists of identifying and managing~     underlying medical abnormalities and the associated psychiatric symptoms. Conventional~     antipsychotics have been the mainstay of treatment of agitation and psychosis associated with~     delirium; but their use is limited in terms of EPS side effects. Second-generation~     antipsychotic agents have been reported to have a lower incidence of extrapyramidal side~     effects and tardive dyskinesia which has resulted in their increased use in the treatment of~     delirious patients. However, there is still no consensus regarding standard pharmacologic~     treatment of this syndrome that takes use of second-generation antipsychotic agents into~     account.~      Risperidone and zotepine have a lower incidence of EPS and are effective in treating~     disturbing psychotic behaviors. We hope to compare the efficacy and safety of risperidone and~     zotepine in the treatment of delirium and the correlation between the severity of delirium~     with autonomic dysfunction.~   "
224341|NCT00621998|"~     We initiate a study with research grant from department of health and Taoyuan mental hospital~     and choose risperidone and olanzapine as study medications. We compare the effects of these 2~     drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive~     dyskinesia to test the hypothesis that these two medications have different effects in~     improving tardive dyskinesia.~   "
224342|NCT00621985|"~     The purpose of this study is to determine if dexamethasone given at night is a more effective~     treatment for congenital adrenal hyperplasia in young children than standard three times per~     day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more~     efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over~     trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone~     and one on nocturnal dexamethasone.~   "
224373|NCT00621582|"~     The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate~     safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients~     with COPD of varying severities over 8 weeks.~   "
224374|NCT00621569|"~     The purpose of the study is to develop a culturally appropriate DASH intervention and test~     the effectiveness of the intervention lower blood pressure in a group of African American~     participants at risk for developing hypertension (pre-hypertension) and those with mild~     hypertension (stage I).~   "
224343|NCT00621972|"~     This is an observational study assessing the impact of conventional dose iodinated contrast~     on the renal function of advanced chronic kidney disease patients undergoing arteriovenous~     fistula evaluation using a standard sodium bicarbonate prophylaxis protocol. In addition,~     this model allows for pre and post procedure measurements of kidney function, providing a~     unique opportunity to assess the utility of novel biomarkers for contrast-induced kidney~     injury.~      Our primary hypothesis is that there will be no change in serum creatinine post-procedure~     when using a standard sodium bicarbonate prophylaxis protocol. Our secondary hypothesis is~     that there will be no change in urinary kidney-injury marker-1 (KIM-1) post-procedure using a~     standard sodium bicarbonate prophylaxis protocol. In addition, we will assess the impact of~     different patient characteristics on the development of contrast-induced kidney injury, such~     as diabetes, coronary artery disease, hypertension, and angiotensin converting enzyme~     inhibitor therapy.~   "
224344|NCT00621959|"~     The study objective is to investigate the efficacy of levocetirizine in reducing symptoms~     associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life~   "
224345|NCT00621946|"~     The purpose is to determine if: 1) Escitalopram treatment will be associated with less oral~     corticosteroid use than placebo in outpatients with severe asthma and moderate or severe~     major depressive disorder (MDD). 2) Escitalopram treatment will be associated with greater~     improvement in asthma symptoms than placebo in outpatients with severe asthma and moderate or~     severe MDD. 3) Escitalopram treatment will be associated with greater depressive symptom~     remission rates than placebo in outpatients with severe asthma and moderate or severe MDD.~   "
224346|NCT00621933|"~     Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the~     treatment and prophylaxis of ocular infections. The present study is set to determine the~     bacteria present on the ocular surface in patients at the time of cataract surgery and to~     assess the rate of resistance of ocular isolates to commonly used topical antibiotics.~   "
224347|NCT00621920|"~     The purpose of this study is to determine the efficacious dose range when used as a bowel~     preparation before colonoscopy.~   "
224348|NCT00621907|"~     The locoregional anaesthesia is increasingly important in surgical practice, often allowing~     to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading~     to a longer hospitalization because of the pain resulting from the surgery. The~     Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars,~     showed its efficiency in post-operative analgesia.~      Method : realization of a double blind prospective randomized study, control versus placebo~     Purpose : to show that the local administration of a unique dose of analgesia reduce the~     post-operative pain with a little or non-invasive technique~   "
224349|NCT00621894|"~     The purpose of this study is to assess the ability of LGD-4665 given daily by mouth to~     increase platelet counts in the treatment of patients with ITP (immune thrombocytopenic~     purpura). LGD-4665 increased platelet counts safely and tolerably compared to placebo in~     healthy volunteers. This study will examine the safety, tolerability and efficacy of 7.5 mg~     capsules of LGD-4665 to increase platelets compared to placebo, randomized 2:1, during~     blinded treatment for 6 weeks. Evaluation of platelet counts, bleeding scores and safety~     parameters will be done weekly. All patients are eligible to continue on active, open~     LGD-4665 treatment for an additional 12 weeks with optimal adjustment of dose for each~     patient.~   "
224350|NCT00621881|"~     This is an open-label study that will compare the pharmacokinetic and safety effects of~     naproxcinod in hepatic impaired patients vs. matching healthy subjects.~   "
224351|NCT00621868|"~     The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of~     ASP1941 in male and female patients with type 2 diabetes mellitus~   "
224352|NCT00621855|"~     The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4~     doses of orally administered dabigatran etexilate, administered twice daily, compared to~     placebo when given in addition to dual antiplatelet treatment in patients with an index event~     (MI) at high risk for new ischaemic cardiovascular events.~   "
224353|NCT00621842|"~     This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with~     type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II~     depression, confirmed via the Structured Clinical Interview for the Diagnostic and~     Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting~     inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton~     Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200~     mg/day.~   "
224354|NCT00621829|"~     This is a clinical study that is designed to study the effects of the supplemental intake of~     enriched omega-3 polyunsaturated fatty acids (fish oil) in patients with moderate to severe~     asthma. Some asthmatics produce a large amount of inflammatory leukotriene proteins—proteins~     that contribute to wheezing and inflammation in the airway. Inhibiting the detrimental~     effects of leukotrienes is a key goal of controller therapy in severe asthmatics. Some~     asthmatic patients appear to have specific mutations of the arachidonate 5-lipoxygenase~     (ALOX5) gene, one gene that regulates the production of the inflammatory leukotrienes.~     Omega-3 fatty acids can interfere with the arachidonic acid pathway and decrease the~     production of leukotrienes, and this may benefit moderate and severe asthma patients. Our~     hypothesis is that omega-3 fatty acid supplements, added on to a patient's asthma medication~     regimen, can decrease the number of minor asthma exacerbations compared to patients who do~     not receive the supplement. Furthermore, we believe that asthma patients with specific ALOX5~     gene mutations will benefit most. We will enroll 30 asthma subjects to take part in this~     trial. They will undergo genotyping of the ALOX5 gene and be treated with omega3-fatty acids~     (fish oil) and placebo over a nine month period. We expect that this strategy will allow us~     to discover which moderate and severe asthma patients will benefit most from supplements of~     omega-3 fatty acids. Treatment of chronic diseases, such as asthma, is a key mission of the~     Center of Health and Nutrition Research.~   "
224355|NCT00621816|"~     Nitroprusside is used commonly in the Intensive Care Unit for long periods of time in order~     to reduce blood pressure. It is not known if the body compensates over time to the blood~     pressure lowering, and if when the nitroprusside is stopped the blood pressure goes up at a~     faster rate and is higher than it was at the start of the treatment. This study will answer~     these questions.~   "
224356|NCT00621803|"~     Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is~     an infection control strategy used to reduce the occurrence of nosocomial infections -~     including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is~     controversial and can lead to adverse effect such as the selection of highly resistant~     pathogens. The purpose of this study was to investigate the effect of oral administration of~     a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by~     Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a~     protective effect against secondary colonisation.~   "
224357|NCT00621790|"~     Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring~     renal replacement therapy.~      Fenoldopam, already used for patients with hypertensive emergencies, could improve renal~     function in critically ill patients with or at risk for acute renal failure.~   "
224358|NCT00621777|"~     Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA~     for treatment of nicotine dependence and may be particularly beneficial in smokers with~     schizophrenia or bipolar disorder. Early experience with varenicline indicates that it will~     be effective for smoking cessation in schizophrenia and in addition, has the potential to be~     therapeutic for cognitive dysfunction in this population. In addition, more data is needed to~     evaluate the safety, tolerability and effectiveness of Varenicline in people with bipolar~     disorder.~      To assess this possibility, we will evaluate the safety and efficacy of 12 months of~     varenicline in schizophrenia or bipolar disorder patients who are able to quit smoking in the~     short term with this treatment. To do so, we will enroll 324 smokers with schizophrenia or~     bipolar disorder from 6 mental health clinics in Massachusetts, New Hampshire, Michigan and~     Minnesota into an open, 12-week smoking cessation program that includes varenicline added to~     weekly group cognitive behavioral therapy (CBT). Those who achieve at least 2 weeks of~     continuous abstinence during the last 2 weeks of the open intervention will be randomized to~     the relapse prevention phase: a 40-week, double blind, placebo-controlled trial of~     varenicline at the dose used to quit smoking added to a tapering CBT schedule. Participants~     will then discontinue study medications and behavioral treatment and enter a 3-month follow~     up phase.~   "
224359|NCT00621764|"~     Safety:~      To describe the safety profiles following vaccination.~      Immunogenicity:~      To describe the immune response after a single dose of vaccine.~   "
224360|NCT00621751|"~     The purpose of this study is to determine if carbamazepine reduces irritability and~     aggression among individuals with traumatic brain injury~   "
224361|NCT00621738|"~     Psychological stress is an independent cardiovascular risk factor. Activation of platelets~     plays an important role in atherosclerosis development and it could one of the mechanisms~     linking psychological stress and cardiovascular diseases~   "
224362|NCT00621725|"~     To determine how patients with advanced cancer and various degrees of hepatic impairment will~     metabolise Cediranib.~   "
224363|NCT00621712|"~     The study investigates the efficacy of a catheter with antibacterial surface coating in~     preventing central venous catheter related infection and the effect of an intensive hygiene~     and catheter care education of the nursing staff on preventing central venous~     catheter-related infection.~   "
224364|NCT00621699|"~     The purpose of this study is to confirm a significant influence of ezetimibe and tacrolimus~     on each others pharmacokinetics~   "
224365|NCT00621686|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib~     may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving~     bevacizumab together with sorafenib may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab~     together with sorafenib works in treating patients with recurrent glioblastoma multiforme.~   "
224366|NCT00621673|"~     Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study~     is to further monitor whether participants with severe Hemophilia A will develop inhibitors~     or antibodies at the later stage when switched from their current recombinant therapy~     produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster~     Kidney cell line.~   "
224367|NCT00621660|"~     The aim of this study is to evaluate if acupuncture prevents or reduces nausea or vomiting~     during radiotherapy~   "
224368|NCT00621647|"~     The purpose of this study is to determine how safe and effective Seroquel (quetiapine~     fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the~     treatment of agitation symptoms in nursing home or assisted care residents.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
224369|NCT00621634|"~     Tardive dyskinesia (TD) is a well-known complication of antipsychotic drug therapy in~     individuals treated for mental disorders such as schizophrenia. It typically consists of~     purposeless, involuntary movements involving the mouth area or the trunk and limb muscles,~     occurring within months or years of drug use. The annual incidence of TD in the population~     treated with antipsychotic drugs is between 1-5%, but the risk is 5-fold greater in older~     individuals. Once triggered, TD is often irreversible and untreatable. Its cause is unknown,~     but an imbalance between chaotic mechanisms triggered by the drugs and natural protective~     factors fighting against these may provide an explanation. One way to activate this~     protective response is to supplement the diet with high doses of essential fatty acids of the~     omega-3 class, which constitute a critical component of nerve cell membranes. Using this~     strategy, one research team showed a 50% reduction in the severity of TD-like movements in~     mice treated with docosahexaenoic acid (DHA). We hypothesize that DHA supplements can do the~     same in patients living with schizophrenia displaying TD movements. Forty (40) subjects~     between 30-75 years of age will be recruited. The participants will be randomized and equally~     distributed in two groups to take either DHA capsules (3 grams a day) or matching placebo for~     12 weeks, after providing informed consent, and TD will be measured with a magnetic tracker~     system and clinical scales. The finding of a beneficial effect with DHA against TD would~     improve the quality of life for thousands of patients under long-term antipsychotic drug~     treatment.~   "
224375|NCT00621556|"~     1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the~          diameter of the pancreatic duct when used during Magnetic Resonance Pancreatography~        2. To demonstrate that RG1068-enhanced MRCP improves detection and characterization of~          intraductal papillary mucinous neoplasms (IPMN) relative to unenhanced MRCP in patients~          with suspected IPMN~        3. To correlate findings on MRCP with histologically confirmed malignancy~   "
224376|NCT00621543|"~     The purpose of this study is to determine the expulsion and continuation rate of an~     intruterine device (IUD) placed immediately after medical abortion.~      Our hypothesis is that immediate-placement of an IUD after completed medical abortion will~     have a similar expulsion and continuation rate to traditional placement (4-6 weeks after~     pregnancy).~   "
224377|NCT00621530|"~     Chronic pain in patients following total hip replacement seems to be a significant problem.~     Previous research has shown that more effective pain management in the early postoperative~     period may decrease the incidence of the development of chronic pain states.~      This study will evaluate whether ketorolac (a non steroidal anti-inflammatory drug) given~     into the spinal fluid before surgery will reduce the area of sensitivity (or pain to light~     touch) following surgery. Patients will be monitored during their postoperative hospital stay~     and then contacted by telephone at 8 weeks and 6 months after surgery and questioned about~     any pain they are having at their surgical site. Patients that are still experiencing pain at~     6 months will be asked to return to the medical center for the study staff to assess their~     pain or sensitivity at the surgical site.~   "
224378|NCT00621517|"~     The purpose of this study is to determine if bupropion will improve the symptoms of restless~     legs syndrome (RLS).~   "
224379|NCT00621504|"~     The purpose of this study is to determine whether ceftaroline is effective and safe in the~     treatment of Community-Acquired Pneumonia~   "
224380|NCT00621491|"~     The aim of this study was to compare the safety and efficacy of warfarin versus placebo,~     administered for 6 months, in the prevention of thromboembolic complications after~     transvenous cardiac devices implantation in high-risk patients.~   "
224381|NCT00621478|"~     Children with seizures are frequently seen in the emergency department. The drug lorazepam,~     which is commonly used, is not labeled by the US Food and Drug Administration for children~     for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a~     study comparing diazepam, a drug that is labeled by the FDA for this indication, with~     lorazepam be performed. The study will show whether one drug is more effective and safe than~     the other.~   "
224382|NCT00621465|"~     This study will evaluate the effectiveness of a psychosocial treatment, Critical Time~     Intervention, in easing the transition from hospital to community in people with severe~     mental disorders.~   "
224383|NCT00621452|"~     This phase I trial is studying the side effects of giving genetically engineered lymphocytes~     together with cyclophosphamide and aldesleukin in treating patients with relapsed or~     refractory mantle cell lymphoma or indolent B-cell non-Hodgkin lymphoma. Placing a gene that~     has been created in the laboratory into white blood cells may make the body build an immune~     response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Aldesleukin may stimulate the white blood cells to kill lymphoma cells.~     Giving genetically engineered lymphocytes together with cyclophosphamide and aldesleukin may~     be an effective treatment for mantle cell lymphoma and B-cell non-Hodgkin lymphoma~   "
224384|NCT00621439|"~     The purpose of this study is to explore whether the drug pegylated-interferon-alfa-2b~     (PEG-IFN) has any effect on a certain type of immune cell (called natural killer cells) in~     patients with eye melanoma.~   "
224385|NCT00621426|"~     Sudden cardiac death due to arrhythmia is the leading cause of death in end-stage renal~     disease (ESRD) patients treated with hemodialysis (HD). As it is anticipated that the number~     of individuals with ESRD will exceed 1.2 million in the next 20 years, sudden death in this~     population has enormous public health impact. Research has shown that arrhythmic events are~     temporally associated with longer periods between HD with a three-fold risk of events in the~     12 hours preceding the longest inter-dialysis interval. The exact cause of these findings is~     unknown.~   "
224386|NCT00621413|"~     The purpose of this study is to observe PSA response and incidence of side effects in~     patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131~     in combination of external beam therapy.~   "
224387|NCT00621400|"~     Amyloidosis results from tissue deposition of amyloid protein, composed mainly by the~     fragments of monoclonal immunoglobulin heavy chains or light chains. Accumulation of amyloid~     protein progressively disrupts normal tissue structure and ultimately leads to organ failure,~     most frequently in the kidneys, heart, liver and peripheral nervous system. A recently~     completed French prospective randomized trial, in patients presenting with newly~     AL-amyloidosis, compared two treatment regimens at the time of diagnosis:~     Melphalan-dexamethasone (conventional oral treatment), versus high dose of Melphalan followed~     by autologous stem cell transplantation (ASCT) (1). High-dose therapy was not associated with~     a better outcome. Melphalan-dex given monthly can be considered as the current standard of~     care, with a median survival of 56 months. The use of a combination of lenalidomide and~     dexamethasone has already been tested in patients with AL-amyloidosis (2). The initial dose~     of lenalidomide at 25 mg/day was poorly tolerated. However, a 15 mg/day dose regimen was well~     tolerated and effective, with an overall hematologic response rate of 67%. Hematologic~     responses were associated with clinical responses. Dispenzieri et al confirmed that the~     combination of Lenalidomide + dexamethasone achieved a 75% hematologic response rate, with a~     42% organ response, and a median follow-up of 17 months in patients still receiving treatment~     (2006). These authors also recommended a lower dose of 15mg/day. The rationale for the~     present investigation is that addition of lenalidomide to the current standard of care~     (Melphalan-dexamethasone) might improve the hematologic response rate and the organ response~     rates both associated with a prolonged survival in patients with AL-amyloidosis. As the~     toxicity of the combination of M-dex + lenalidomide is unknown in patients with~     AL-amyloidosis, the dose of lenalidomide will start from the lowest one available, i.e., 5~     mg/day and increased from 5 to 5 mg up to a maximum dose of 15 mg in combination with M-dex~     in 3 consecutive cohorts of patients, according to toxicity. When the optimal dose of~     lenalidomide will be defined, 9 additional patients will be included in the trial at the~     recommended dose-level to assess the feasibility of the combination M-dex-lenalidomide.~   "
224388|NCT00621387|"~     This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month~     treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice~     daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at~     regular intervals until 6 months. The main outcome measure is recovery from arthritis, and~     secondary outcome measures include swollen and tender joint counts, Ritchie index, joint~     pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will~     also address the safety and tolerability of long-term antibiotic treatment. 56 patients are~     enrolled and the enrollment of patients has been completed.~   "
224391|NCT00621348|"~     Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important~     reason for this high incidence could be use of hypotonic fluids in sick children for~     maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect~     of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized~     children.~      Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5%~     dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when~     compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children~     receiving intravenous maintenance fluids.~   "
224392|NCT00621335|"~     The objective of this research study is to compare the tolerability and effectiveness of~     Combigan(brimonidine tartrate/timolol maleate) and Cosopt (dorzolamide hydrochloride)in the~     treatment of open angle glaucoma or ocular hypertension.~   "
224393|NCT00621322|"~     This observer blind study will assess the safety and immunogenicity of different formulations~     of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a~     positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA~     Amendment Act, Sep 2007.~   "
224394|NCT00621309|"~     Adverse drug-drug interactions (DDIs) are responsible for approximately 3% of all~     hospitalizations in the US, perhaps costing more than $1.3 billion per year. One of the most~     common causes of DDIs is the when one drug alters the metabolism of another. A key enzyme in~     the liver and intestine, called cytochrome P450 3A4 (CYP3A4) is generally considered to be~     the most important drug metabolizing enzyme. The gene for CYP3A4 can be 'turned on' by the~     presence of certain other drugs, resulting in much higher levels of CYP3A4 in the liver and~     intestine. Thus, when a drug that induces CYP3A4 is given with or before another drug that is~     metabolized by 3A4, a 'drug-drug' interaction occurs because the first drug (the inducer)~     greatly changes the rate at which the second drug (CYP3A4 substrate) is removed from the~     body. Many drugs increase CYP3A4 activity by binding to a receptor called the~     Pregnane-X-Receptor (PXR), which is a major switch that controls the expression of the CYP3A4~     gene. Using human liver cells we have demonstrated that sulforaphane (SFN), found in~     broccoli, can block drugs from activating the PXR receptor, thereby inhibiting the switch~     that causes CYP3A4 induction. The purpose of this project is to determine if SFN can be used~     to block adverse DDIs that occur when drugs bind to and activate the PXR receptor and~     subsequently induce CYP3A4 activity. We will recruit 24 human volunteers to participate in~     the study. This project will determine whether SFN can prevent the drug Rifampin from binding~     to PXR and increasing CYP3A4 activity in humans following oral administration of SFN~     (broccoli sprout extract). The rate of removal of a small dose of the drug midazolam will be~     used to determine the enzymatic activity of CYP3A4 before and following treatment with~     Rifampin, in the presence or absence of SFN, since midazolam is only eliminated from the~     bloodstream by CYP3A4. . We predict that SFN will prevent the increase in midazolam clearance~     (metabolism) that normally follows treatment with the antibiotic, rifampicin.~      This research is important because it could potentially lead to a simple, cost-effective way~     of preventing one of the most common causes of adverse drug-drug interactions that occurs~     today. For example, rifampicin, which is a cheap and effective antibiotic used to treat TB,~     cannot be used in HIV/AIDS patients because it increases the metabolism of many of the~     antiretroviral drugs used to treat HIV/AIDS. TB is a major opportunistic infection in AIDS~     patients, so this is a serious clinical problem, especially in developing countries where~     more expensive alternative drug therapies are not available. We hypothesize that~     co-formulation of rifampicin with SFN could block this drug-drug interaction without altering~     its efficacy, thereby allowing its use in HIV/AIDS patients infected with TB. This is but one~     example of numerous drug-drug interactions that occur via this mechanism.~   "
224395|NCT00621296|"~     The purpose of this study is to assess the efficacy and safety after administration of MP-424~     to patients with chronic hepatitis C.~   "
224396|NCT00621283|"~     1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the~          diameter of the pancreatic duct when used during Magnetic Resonance Pancreatography.~        2. To demonstrate that RG1068-enhanced MRCP improves image quality relative to unenhanced~          MRCP in patients with unexplained acute recurrent pancreatitis (ARP) and chronic~          pancreatitis.~        3. To evaluate if the use of RG1068-enhanced MRCP improves structural delineation of the~          pancreatic duct as compared to the non-enhanced MRCP.~        4. To assess pancreatic exocrine function by quantifying pancreatic fluid output into the~          duodenum and the apparent diffusion coefficient of the pancreas.~   "
224397|NCT00621270|"~     The purpose of this study is to determine whether BCI-540 80 mg given once daily (q.d.) or~     three times daily (t.i.d.) is effective in the treatment of major depression with concomitant~     anxiety.~   "
224398|NCT00621257|"~     Research has shown that children with Inflammatory Bowel Disease may have lower levels of~     vitamin D than healthy children, especially in the winter. Vitamin D is important for growing~     and maintaining healthy bones throughout life, and this is particularly important, since~     children with IBD frequently have low bone density. It may also be helpful in the treatment~     of IBD itself, because it helps reduce inflammation. Vitamin D levels are measured by the~     amount of 25 OHD in the blood; however, measuring this level on a regular basis is not yet~     the standard for children with IBD. The purpose of this study is to find the best way to~     treat low vitamin D levels, and to maintain good vitamin D levels throughout the year. It~     will also test whether having higher vitamin D levels will improve the bone health of~     children with IBD, and whether it will help them have milder disease.~   "
224399|NCT00621244|"~     This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or~     anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies~   "
224400|NCT00621231|"~     The aim of the proposed study is to investigate the effects of different amounts of protein~     intake primarily from meat on muscle function, immune response, mental function, proteomics,~     biochemical regulators of protein metabolism, energy expenditure, and composition in young~     healthy males.~   "
224401|NCT00621218|"~     To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or~     twice daily in female subjects with rosacea.~   "
224402|NCT00621205|"~     Lifestyle and genetic factors interact in the development of obesity and the metabolic~     syndrome. The molecular mechanisms underlying the beneficial dietary modifications are,~     however, unclear. We aimed to examine the effect of the long-term 30 moderate weight~     reduction on gene expression in adipose tissue (AT) and to identify genes and gene clusters~     responsive to treatment and thereby likely contributing to the development of the metabolic~     syndrome. Thus, randomized controlled and individualized weight reduction and physical~     exercise intervention was conducted. In the WR group, glucose metabolism improved that was~     not seen in other groups. Moreover, an inverse correlation between the change in SI and the~     change in body weight was found (r =-0.44, p=0.026). Down-regulation of gene expression~     (p<0.01) involving gene ontology groups of extracellular matrix, cell death was seen. Such~     changes did not occur in the other groups.~   "
224403|NCT00621192|"~     Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is~     used in premature and young infants, the correct dose is not known. The purpose of this study~     is to determine the correct dose and the safety of meropenem for the treatment of complicated~     intra-abdominal infections in these young babies.~   "
224404|NCT00621179|"~     This prospective randomized trial evaluates whether one can predict which infertile women~     with endometriosis who are candidates for in vitro fertilization will benefit from prolonged~     therapy with a GnRH agonist by the determination of the absence of endometrial expression of~     the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which~     all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for~     in vitro fertilization and then undergo randomization to a three month course of a depot~     preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian~     stimulation or standard therapy. prio~   "
224405|NCT00621166|"~     To determine the pharmacokinetic profile of generic lopinavir/ritonavir tablets To~     investigate the possible influence of pregnancy and duration of pregnancy To determine the~     antiviral activity and safety of generic lopinavir/ritonavir® Compare pharmacokinetics~     parameters before and after pregnancy.~   "
224406|NCT00621153|"~     To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either~     candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen~   "
224407|NCT00621140|"~     To investigate efficacy, safety and tolerability of BI 1356 versus placebo~   "
224408|NCT00621114|"~     The clinical study aims at providing data on antimicrobial efficiency and a supposed~     additional preventive effect on catheter-related infections of a catheter with antibacterial~     surface coating in comparison to standard catheters without coating.~   "
224409|NCT00621101|"~     The purpose of this study is to confirm a significant influence of ezetimibe and sirolimus on~     each others pharmacokinetics~   "
224410|NCT00621088|"~     This is a study to compare the new nail INTERTAN with a Sliding Hip Screw in treating a~     specific group of hipfractures (trochanteric and subtrochanteric fractures).~      Are there differences in terms of pain, early and late functional mobility and complications~     between the to implants (and methods of operation)?~   "
224411|NCT00621075|"~     The goal of our study is to correlate data from non-invasive tests such as perfusion lung~     scans with hemodynamic measurements from right heart catherizations.~   "
224412|NCT00621062|"~     Through a prospective RCT evaluate and compare the three new endovenous methods for great~     saphenous vein ablation (Radiofrequency, endovenous laser and foam sclerotherapy) versus high~     ligation and stripping. Procedure (proof-of-concept) and patient related (clinical outcome)~     factors will be studied.~   "
224413|NCT00621049|"~     Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin,~     docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with~     completely resected stage IB, II, and select III NSCLC.~   "
224414|NCT00621036|"~     RATIONALE: Vaccines made from a person's cancer proteins may help the body build an effective~     immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may~     increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine~     therapy together with GM-CSF may make a stronger immune response and kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving vaccine therapy~     together with GM-CSF works in treating patients with CNS lymphoma.~   "
224415|NCT00621023|"~     This will be an open-label, non-randomized trial pilot phase II trial open to patients with~     myelodysplastic syndrome. The purpose of the study is to find out if the combination of~     decitabine, arsenic trioxide and ascorbic acid is safe.~   "
224416|NCT00621010|"~     This study is the first human exposure for the drug candidate CTS21166 in healthy male~     volunteers~   "
224417|NCT00620997|"~     Introduction: Traumatic injuries to the outer covering of the eye (the cornea) are a common~     emergency department complaint. They cause significant patient distress including pain, loss~     of sleep and missed work days. There is currently no accepted, uniform approach to pain~     management in this patient population. Emergency medicine and ophthalmology texts state that~     prolonged use of medications that anesthetize the cornea is not recommended. Several recent~     publications in the ophthalmology literature show that the outpatient use of dilute local~     anesthesia in patients after eye surgery is a safe and effective method of pain control. In~     this study, we used Proparacaine (a local anesthetic), in a similar manner, for the~     outpatient emergency department management of traumatic corneal injuries.~      Methods: We performed a clinical trial on a sample of adult patients presenting with~     traumatic corneal injuries to two university affiliated emergency departments in London,~     Canada.~      Patients providing signed informed consent to participate in the study received a vial of~     clear liquid that contained either Proparacaine or plain water (placebo), a pain log, topical~     antibiotics and oral Acetaminophen (Tylenol) with Codeine for breakthrough pain.~      Patients were instructed to use the study drug on an as-needed basis for the next seven~     days. Patients completed a pain scale describing their discomfort immediately prior to, and~     five minutes after self-administration of the study drug. All patients were followed closely~     in an ophthalmology outpatient clinic on Days 1, 3 and 5 after presentation to the emergency~     department. At the last ophthalmology clinic visit, the patients' pain logs were collected.~      The protocol was approved by the Research Ethics Board for Health Sciences Research Involving~     Human Subjects at the University of Western Ontario.~   "
224418|NCT00620984|"~     Lactation (breastfeeding) mastitis is an acute infection of the milk ducts of the~     breastfeeding woman. Staphylococcus aureus (S. aureus) is the infectious germ most commonly~     associated with lactation mastitis. Twenty percent of the general population are carriers of~     Staphylococcus aureus, which means that they carry the infectious germ but do not become ill~     from it. It has been suggested that mothers who are carriers of S. aureus in their nostril~     may be at an increased risk of developing lactational mastitis, however; this has not been~     clinical proven.~      We are studying the relationship between S. aureus carrier status of breastfeeding mothers~     and infants and the risk of developing lactational mastitis. Additionally, we are collecting~     questionnaire data in an attempt to better define factors predisposing women to lactation~     mastitis.~   "
224419|NCT00620971|"~     This trial will evaluate whether the sequential administration of~     Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the~     Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival~     advantage in patients with locally advanced or metastatic NSCLC.~   "
224420|NCT00620958|"~     This study will compare the effectiveness of individual cognitive behavioral therapy with two~     distinct types of parent involvement versus individual cognitive behavioral therapy without~     parent involvement in treating children with anxiety disorders. Hypothesized mediator of~     change for eac of the two parent treatment conditions also will be evaluated~   "
224437|NCT00620737|"~     The purpose of this study is to evaluate the safety profile and the treatment effect of~     Isolagen TherapyTM and placebo when administered to stable restrictive burn scars of an~     affected joint area.~   "
224421|NCT00620945|"~     Cardiopulmonary bypass [CPB] in small size bodies can result in decreased peripheral~     perfusion. This results in anaerobic metabolism as evidenced by lactic acidosis. High flow~     perfusion results in systemic hypertension which is accentuated by moderate hypothermia~     commonly used during cardiopulmonary bypass. Phenoxybenzamine [PBZ] is an arteriolar~     vasodilator that acts by irreversibly blocking the alpha adrenergic receptors. It causes~     vasodilatation allowing high flow, low pressure CPB. It has been used extensively outside US~     in Canada, Europe and Australia. In the US oral PBZ is FDA approved, whereas intravenous PBZ~     is only available as an investigational drug~   "
224422|NCT00620932|"~     The primary objective is to determine the feasibility and acceptability of a home-based~     endurance exercise program among men diagnosed with clinically localized prostate cancer.~   "
224423|NCT00620919|"~     1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the~          diameter of the pancreatic duct when used during Multidetector Computed Tomography~          (MDCT) of the pancreas.~        2. To demonstrate that RG1068-enhanced MDCT improves image quality of the pancreas in~          patients with chronic pancreatitis.~        3. To evaluate if RG1068 enhanced MDCT results in improved delineation of structural~          abnormalities of the pancreatic duct as compared to non-enhanced MDCT.~   "
224424|NCT00620906|"~     The purpose of this study is to examine the effects of manipulation on sacroiliac joint~     motion using a Polhemus motion capture system.~   "
224425|NCT00620893|"~     This study will evaluate and compare 2 artificial tears in their ability to reduce post LASIK~     dry eye signs and symptoms. The secondary endpoint of this study is to evaluate refractive~     regression in these patients. The 'Refractive Outcome' data point will be defined as the~     difference between the post-op spherical equivalent (SE) and the pre-op targeted SE.~   "
224426|NCT00620880|"~     Primary objective of the trial:~      To determine at which concentration the fusion protein MAT Fel d1 degranulates basophils of~     cat dander allergic patients, in comparison to a cat dander extract and to Fel d1 alone~   "
224427|NCT00620867|"~     To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with~     osteoarthritis (OA) of the knee.~   "
224428|NCT00620854|"~     This study compares the performance of different doses of oral recombinant salmon calcitonin~     (rsCT).~   "
224429|NCT00620841|"~     A retrospective analysis of the influence of gene polymorphisms on drug interactions between~     calcineurin-inhibitors and concomitant drugs in renal transplant patients.~   "
224430|NCT00620828|"~     The purpose of this study is to use a new combination of anesthesia techniques in an attempt~     to minimize early pain after surgery and improve the patient's ability to participate more~     fully with physical therapy. Total knee replacement patients who participate will receive the~     standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The~     study is looking at the added benefits of including an injection of numbing medication~     (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to~     compare the outcomes we will also have a group of patients who will receive a saline~     injection as opposed to the numbing medication. Patients are randomly assigned to a group.~     Outcomes are measured up until twenty-four hours following the surgery.~   "
224431|NCT00620815|"~     Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years~     and above (as part of a tetravalent vaccine)~   "
224432|NCT00620802|"~     CG106 is a Phase I open-label, randomized, multiple-dose, two-way crossover study to~     characterize the pharmacodynamics and pharmacokinetics of the investigational fixed-dose~     combination product CGT 2168 (clopidogrel, 75 mg and omeprazole, 20 mg) relative to Plavix®~     (clopidogrel, 75 mg).~      Healthy volunteer subjects will undergo two dosing periods. In each 7-day dosing period,~     subjects will receive oral doses of study drug consisting of open-label CGT 2168 or Plavix®~     in the order determined by the randomization schedule. Each period of dose administration~     will be separated by a two-week washout period. Study exit will occur 1 week after Dosing~     Period 2. The expected total duration of participation is 8 weeks (56 days), including a~     screening visit on or within 21 days prior to enrollment.~      On the day before Day 1 and Day 7 in each dosing period, subjects will be admitted to the~     Phase I unit. Blood samples to determine ADP-induced platelet aggregation will be collected~     pre-dose on Day 1 and 2 h after dosing on Day 7. Plasma concentrations of clopidogrel parent~     and clopidogrel carboxylic acid metabolite will also be measured pre-dose on Day 1 and~     pre-dose and serially after dosing on Day 7.~   "
224433|NCT00620789|"~     This study is a randomized clinical trial to test the efficacy of Cognitive-Behavioral~     Insomnia Therapy when used in isolation or in combination with antidepressant medication~     (escitalopram) among patients with Major depressive disorder and insomnia.~   "
224434|NCT00620776|"~     The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined~     medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the~     current study are to conduct a late stage treatment development study. The goal of this stage~     of research is to provide a preliminary answer to the question and to gather data to estimate~     intervention parameters (e.g., effect size, attrition rates, response rates) that would~     assist in planning further research.~   "
224435|NCT00620763|"~     The impact of protein sources such as beef as part of Western diet on calcium retention~     remains controversial. We propose to test the hypothesis that the positive effect of high~     protein intake (especially from meat protein) can offset the negative effect of~     protein-induced net acid load on bone metabolism and the retention of body calcium. Healthy~     postmenopausal women recruited from the community will consume two diets differing in meat~     protein and acid load for 7 weeks. Calcium retention from diets will be determined using a~     highly sensitive measurement of whole body retention of a calcium isotope added to the diet.~   "
224436|NCT00620750|"~     Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The~     efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has~     been demonstrated in clinical trials, raising the prospect of integrating pharmacologic~     treatment for alcohol dependence into general medical care settings. However, the feasibility~     of implementing this United States Food and Drug Administration approved treatment in the~     front-line settings in which it is most needed has not been demonstrated. This is an~     open-label pilot feasibility study of implementing treatment with Vivitrol in primary care~     medical clinics in a safety net hospital system affiliated with an urban academic center.~   "
224438|NCT00620724|"~     The objective of our study is to determine the clinical utility related to the maintenance~     oral nifedipine therapy in patients with symptomatic placenta previa. This study is a~     prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of~     hospitalized patients with symptomatic placenta praevia. All patients may initially receive~     oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are~     randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one~     every 8 hours) until 37 weeks of gestation.~      The primary outcome for the trial is the length of pregnancy in days after the enrollment. A~     sample size calculation is designed to detect at least a 14 -day difference in time gained in~     patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per~     group would have a 80 % chance of detecting this difference at the 5 % level of significance.~   "
224439|NCT00620711|"~     The hypothesis is that premature infants' can have enough cooling applied to cool their brain~     to decrease CNS injury without cooling their body.~   "
224440|NCT00620698|"~     Trials evaluating new therapies for stopping or slowing the progression of ALS depend~     critically upon the use of outcome measures to assess whether a potential treatment is~     effective. The more effective an outcome measure, the fewer patients need to be enrolled and~     the shorter the trial. Many outcome measures have been used over the years, including~     strength assessments, breathing tests, functional status surveys, and nerve testing, but all~     are far from ideal. A new method, called electrical impedance myography (EIM) appears to be~     especially promising in that it provides very consistent data from one testing session to the~     next, is sensitive to the muscle deterioration that occurs in ALS, and is entirely painless~     and non-invasive. In this study, investigators from multiple institutions plan to compare~     several different outcome measures, including EIM, in approximately 120 ALS patients, with~     each patient being followed for a period of one year. All of these measures will be compared~     to one another and an assessment of their ability to detect disease progression made. Our~     goal will be to determine whether EIM can serve as a valuable new outcome measure, ultimately~     leading to substantially faster, more effective ALS trials requiring fewer patients.~   "
224441|NCT00620685|"~     The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well~     tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not~     effect the blood levels of methotrexate.~   "
224442|NCT00620672|"~     Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for~     humans, and are known to be important to reducing the risk of certain diseases, particularly~     those related to neural system, cardiovascular system and immune system. Among the different~     n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the~     brain and retina, and is accumulated in large amounts in these organs during the last~     trimester of fetal development and first few months after birth. The n-3 fatty acids are~     present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA~     which is only found in animal tissue fats, with fatty fish being the richest dietary source.~     Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow~     in human and possibly inadequate to support the needs for DHA for the developing brain.~     Information from our work and those of others has suggested that DHA is important during~     pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women~     in low, or that improvement in the DHA status of Canadian women during pregnancy will have~     benefit to early infant an child development. There is no evidence that infants of vegans and~     vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of~     this study is to investigate whether a dietary supplement of DHA during pregnancy has any~     effect on infant birth weight, or indices of infant growth, visual, mental and motor skill~     development.~   "
224443|NCT00620659|"~     The purpose of this study is to determine the safety and efficacy of MK0249 in treating~     refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep~     Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP)~     therapy.~   "
224444|NCT00620646|"~     To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard~     dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel~     resistance~   "
224445|NCT00620633|"~     This study will test the safety of giving you specialized white cells from your donor. They~     are called WT1 sensitized T cells. They have been grown in the lab and are immunized against~     a protein. The protein is called the Wilms' tumor protein, or WT1. Your leukemic cells make~     too much of this protein. We want to learn whether the WT1 sensitized T cells will attack the~     protein and kill the leukemia cells.~   "
224446|NCT00620620|"~     The purpose of the study is to determine the safety, tolerability and pharmacokinetics of~     zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers~   "
224447|NCT00620607|"~     To assess the response rate of huC242-DM4 given as an intravenous infusion to patients with~     metastatic or locally advanced gastric or gastroesophageal junction cancer.~   "
224448|NCT00620594|"~     This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of~     phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed~     by a safety dose expansion part:~      Dose escalation part (advanced solid tumors, including patients with breast cancer being~     treated with trastuzumab):~      Patients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat~     every 28 days in the absence of disease progression or unacceptable toxicity.~      Cohorts of at least 3 patients receive escalating doses of BEZ235, as single agent or in~     combination with trastuzumab, until the maximum tolerated dose (MTD) is determined. The MTD~     is defined as the dose expected to produce during the first course of treatment dose-limiting~     toxicity in 33% of patients.~      Once the MTD has been defined, the safety expansion parts of the trial will be opened for~     enrollment.~      Safety dose expansion part (advanced solid tumors, including patients with breast cancer~     being treated with trastuzumab):~      Patients will be treated with BEZ235, as single agent or in combination with trastuzumab,~     given at the MTD, once daily. Treatment of patients will continue until disease progression~     or occurrence of unacceptable side effects.~   "
224490|NCT00620048|"~     The purpose of this study is to determine if cell therapy with your own cells (autologous~     cells) delivered with a catheter to regions of the heart with poor blood flow will be safe~     and if it will improve your ejection fraction and heart failure symptoms.~   "
224449|NCT00620581|"~     The efficacy of SSRI use to relieve the symptoms associated with premenstrual dysphoric~     disorder has been established. We proposed to test the hypothesis that intermittent treatment~     with paroxetine administered during the luteal phase of the menstrual cycle only is more~     effective than placebo in improving symptoms of PMDD. This was a double-blind,~     placebo-controlled, three-arm parallel group study of patients with PMDD. Menstruating women~     18 years of age or older who met criteria for inclusion in the study were randomized to one~     of three arms: paroxetine 10mg/day during the luteal phase of the menstrual cycle; paroxetine~     20mg/day during the luteal phase of the menstrual cycle; placebo daily during the luteal~     phase of the menstrual cycle. The objective was to evaluate the efficacy and safety of~     intermittent treatment of paroxetine in women with PMDD.~   "
224450|NCT00620568|"~     This is a randomized, inpatient, ascending multiple dose study to assess safety and~     tolerability of SLV-313 SR tablets administered orally to subjects with schizophrenia and~     schizoaffective disorder.~   "
224451|NCT00620555|"~     Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric~     patients with partial seizures~   "
224452|NCT00620542|"~     A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing~     the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic~     disease burden as measured by intravascular ultrasound in patients with coronary artery~     disease.~   "
224453|NCT00620529|"~     We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in~     women with PCOS. The purpose of this study therefore is to examine the effects of fish oils~     on blood pressure, heart rate variability and liver fat content in obese women with the~     polycystic ovary syndrome.~   "
224454|NCT00620516|"~     This is a descriptive observational open non-comparative study of the safety and efficacy of~     tiotropium inhalation capsule given at 18mcg once a day for 30 days among Korean patients~     with COPD. At Visit 1, patients who are diagnosed as COPD will be prescribed tiotropium~     inhalation capsule at 18mcg once daily (at the same time). Patients' FEV1 will be assessed~     before start of treatment (Visit 1) and at the end of the 30 day treatment period (Visit 2).~     Occurrence of adverse events will also be asked from the patient at the end of the 30 day~     treatment period. Patients will be informed by the attending physicians to immediately report~     the occurrence of serious adverse events.~   "
224455|NCT00620503|"~     This is an open-label, randomized, single-center, outpatient, unblinded, single-dose,~     three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34~     years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state,~     formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B);~     successive dosing will be separated by at least one week intervals from the previous dosing.~     Blood will be collected prior to taking the dose, and following the dose for 24 hours~     post-dose. Subjects will be discharged from the study after the last blood sample is obtained~     after the third dose of Proellex®. Safety will be assessed throughout the study.~   "
224456|NCT00620490|"~     osteolateral thoracotomy is a painful surgical procedure.Thoracic epidural analgesia (TEA) is~     usually considered as the gold standard for postoperative thoracic analgesia.~     Unfortunately, it's not always possible to realize it because of contraindications or because~     of technical failures.Analgesia using a paravertebral block is an alternative to the TEA : it~     provides an unilateral sensitive and sympathetic block using a catheter.In our study, the~     catheter will be placed by the thoracic surgeon at the end of the surgical procedure, under~     direct vision, to insure maximal security also on patients on antiplatelets agents,~     anticoagulants or with haemostasis disorders (the placement of the catheter by the~     anaesthetist with the loss of resistance technique is contraindicated in these~     cases).Patients will be randomized to receive either a continuous 48-hours infusion of~     ropivacaine 0,5% or saline serum in the control group.All patients are connected to a PCA~     pump with intravenous morphine and will receive paracetamol and nefopam.The visual analogic~     scale (VAS) at rest and on movement, total morphine consumption and side effects will be~     recorded during the first 48 hours after surgery. The aim of this study is to prove a~     decrease of pain at rest and on movement, a decrease of the cumulated total morphine dose~     consumption and a decrease of the side effects (nausea, vomiting, pruritus, sedation,~     bradypnea, urinary retention).~   "
224457|NCT00620477|"~     Patients who suffered from a rupture of the Anterior Cruciate Ligament with instability of~     the knee joint, will be treated with an operative ACL-reconstruction. One group of patients~     will stay one night in the hospital and go home the other day (Group I). The other group of~     patients will go home the same day of surgery (Group II). All patients will undergo the same~     arthroscopic reconstruction of the ACL. Anesthesia will be performed on each patient in a~     classic manner. At the end of the surgery each group of patients will be randomly divided in~     two subgroups: one group will get an injection in the knee joint with 20 ml of physiological~     fluid (Group Ia en IIa), the other group will get an injection in the knee joint with 20 ml~     of chirocaine 0.125%, a widely used pain-medicine (Group Ib and IIb). This will happen in a~     double blind, randomized way. The whole procedure takes about one hour. After surgery~     patients are brought to the recovery room and are observed every 30 minutes for the duration~     of 4 hours. Before being brought to their rooms, patients will have to fill in a VAS: Visual~     Analogue Scale, to determine their pain. After being brought to their rooms, the patients~     will have the choice of going home the same day or staying in the hospital for one night,~     according to the amount of pain they are in. That moment it will be possible to switch~     groups. Patients who go home the same day of surgery will be contacted by phone the day after~     to fill in a question form. Patients who were admitted for one night will be seen before~     their leave to fill in the same question form.~   "
224458|NCT00620464|"~     The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and~     Radiopaque IMPLANON.~   "
224459|NCT00620451|"~     This study was conducted to assess the safety and efficacy of larazotide acetate versus~     placebo in inducing remission in subjects with active celiac disease.~   "
224491|NCT00620035|"~     The primary purpose of this study is to evaluate the use of the next generation applicator~     and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives~     include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and~     safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant,~     and to assess participant expectations and satisfaction with the Radiopaque Implant.~   "
224460|NCT00620438|"~     There are increasing numbers of HIV-infected patients in sub-Saharan Africa receiving~     antiretroviral drugs and/or rifampicin based antituberculous therapy. HIV infected patients~     are at an increased risk of contracting malaria. Increasing resistance to anti-malarials such~     as chloroquine, amodiaquine, fansidar, sulphadoxine-pyrimethamine in East and West Africa has~     led the WHO to recommend artemether-lumefantrine (Coartem®- Novartis) as first line therapy~     for malaria for adults and children. As early as 2004, fourteen countries in sub-Saharan~     Africa had adopted this guideline as national policy.~      There are no data on the interaction between Coartem® and any of the antiretroviral agents.~     Both components of Coartem® are substrates for the 3A4 isoform of cytochrome P450. Despite~     the lack of data, antiretroviral drugs and/or antituberculous drugs in addition to Coartem®~     are of necessity co-prescribed daily in the African setting. Nevirapine, efavirenz and~     rifampicin are known inducers of cytochrome P450 3A4. A technical consultation convened by~     WHO in June, 2004 concluded that additional research on interactions between antiretroviral~     and antimalarial drugs is urgently needed.~      We propose to perform a suite of pharmacokinetic studies to evaluate these interactions in~     HIV infected Ugandan patients. The aim of these studies is to evaluate the pharmacokinetic~     interaction between Coartem® and commonly co-prescribed inducers of 3A4 i.e. nevirapine,~     efavirenz and rifampicin.~        1. Comparison of steady state pharmacokinetics of Coartem® in HIV-infected patients prior~          to commencement of nevirapine and at nevirapine steady state~        2. Comparison of steady state pharmacokinetics of Coartem® in HIV-infected patients prior~          to commencement of efavirenz and at efavirenz steady state~        3. Comparison of steady state pharmacokinetics of Coartem® in Ugandan patients at~          rifampicin steady state and without rifampicin~   "
224461|NCT00620425|"~     Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled~     with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over~     2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.~   "
224462|NCT00620412|"~     The purpose of this study is to determine whether the food supplement called Lactobacillus~     rhamnosus GG (LGG) may help boost the effectiveness of the nasal flu vaccine. Preliminary~     data from several studies of healthy volunteers suggest that LGG boosts the immune response~     to vaccines. Fifty-two subjects will be recruited into the study, all will receive the nasal~     flu vaccine. Twenty-six will receive capsules that contain LGG, 26 will receive placebo~     capsules. Blood and nasal specimens will be collected weekly for four weeks and at eight~     weeks to evaluate the initial mucosal and systemic immune response to the immunization. This~     study will provide preliminary data on whether the immune response of healthy adults to the~     nasal influenza vaccine can be boosted by LGG.~   "
224463|NCT00620399|"~     This study evaluated the hypothesis that bracing following lumbar spinal fusion surgery~     improves functional outcome following surgery~   "
224464|NCT00620386|"~     We studied intubating conditions and hemodynamic changes during endotracheal intubation~     employing either Bonfils intubating fiberscope or the conventional Macintosh laryngoscopy in~     80 healthy patients candidates for elective surgery requiring endotracheal intubation. We~     omitted neuromuscular blocking drugs from the induction regimen.~   "
224465|NCT00620373|"~     We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast~     Imaging (a new gamma-camera based breast imaging technology) in women with dense breast~     tissue who are at increased risk for breast cancer.~   "
224466|NCT00620360|"~     It has been widely documented that fructose overfeeding increases plasma triglycerides and~     hepatic de novo lipogenesis, and impairs insulin sensitivity in healthy male volunteers. The~     effect of gender on the metabolic responses to fructose remains an important open question,~     however.~      The objective of this study is to compare the effect of an acute oral fructose load on~     carbohydrate and lipid metabolism in healthy young males and females.~   "
224467|NCT00620347|"~     the investigators will conduct a phase II trial to evaluate the efficacy and toxicity of~     Sunitinib in patients with recurrent SCLC.~   "
224468|NCT00620334|"~     Despite the development of effective medications for treatment, asthma remains a significant~     contributor of morbidity, mortality, and financial hardship to patients with the disease. An~     estimated 300 million people worldwide have asthma, making it one of the most common chronic~     diseases in the world. Asthma accounts for 250,000 deaths per year worldwide, and 1.7 million~     emergency room visits per year in the United States. Cost of asthma in the United States was~     an estimated $12.7 billion dollars per year in 1998, and the prevalence is increasing. In~     2002, there were 13.9 million outpatient asthma visits to private physician offices and~     hospital outpatient departments, and 484,000 asthma hospitalizations. Children 5-17 years of~     age missed 14.7 million school days, and adults missed 11.8 million work days due to asthma~     in 2002.~      There is no single diagnostic test or symptom that defines asthma. Asthma is a syndrome~     consisting of a constellation of symptoms that include wheeze, cough, shortness of breath,~     and chest tightness. The diagnosis of asthma takes into account history, physical examination~     findings, and objective measures of pulmonary function and markers of inflammation. In many~     cases the diagnosis is not in question, allowing for early recognition and appropriate~     treatment. In other cases, confounding factors makes the diagnosis both challenging and time~     consuming for the physician and the patient. According to the National Asthma Education and~     Prevention Program Expert Panel Report 2, asthma is defined as:~      a chronic inflammatory disorder of the airways in which many cells and cellular elements~     play a role, in particular, mast cells, eosinophils, T lymphocytes, macrophages, neutrophils,~     and epithelial cells. In susceptible individuals, this inflammation causes recurrent episodes~     of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the~     early morning. These episodes are usually associated with widespread but variable airflow~     obstruction that is often reversible either spontaneously or with treatment. The inflammation~     also causes an associated increase in the existing bronchial hyperresponsiveness to a variety~     of stimuli.~      Airway obstruction and reversibility is measured by pulmonary function testing before and~     after inhalation of a short acting beta agonist. Airway hyperresponsiveness is measured by~     methacholine challenge.~      Estimates of asthma prevalence are generated by the use of written questionnaires in~     epidemiologic studies. , One of the difficulties with reliance on questionnaires is that~     patients often misinterpret the questions or fail to answer the question altogether. In this~     study, a physician will review the questionnaire with the patient in order to clarify each~     question.~      The goal in this study is to evaluate a simplified set of questions that can be easily~     implemented into clinical practice that will predict the presence or absence of asthma.~      Hypothesis~      A simplified questionnaire will predict asthma in adults.~      Study Objectives~      § Primary Objective~      o To evaluate the predictive value of a questionnaire designed to diagnose asthma in adults~   "
224469|NCT00620321|"~     The purpose of this study is to understand the safety profile of LY2181308 sodium~     administered in combination with idarubicin and cytarabine to patients with relapsed or~     refractory AML.~   "
224470|NCT00620308|"~     This human physiologic study will evaluate the effects of a new drug called CD-NP in~     individuals with stable chronic heart failure, with a focus on evaluating responses of the~     kidneys and the hormonal system.~   "
224471|NCT00620295|"~     RATIONALE: Bortezomib may stop the growth of solid tumors by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as gemcitabine, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving bortezomib together with~     gemcitabine may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and~     gemcitabine in treating older patients with advanced solid tumors.~   "
224472|NCT00620282|"~     This trial is conducted in the United States of America (USA). The purpose of the trial is to~     assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who~     are on diet and lifestyle changes or treated with metformin alone.~   "
224473|NCT00620269|"~     The use of induction chemotherapy is feasible and effective. It is also logistically~     beneficial for decreasing micrometastases and radiation-related toxicity by decreasing tumor~     burden before definite locoregional concurrent therapy. Previously the investigators~     conducted several phase II study of IP chemotherapy in advanced NSCLC and demonstrated that~     IP chemotherapy has a promising activity and readily manageable toxicity profile. Given the~     encouraging activity of IP chemotherapy in the advanced stage setting, the investigators~     postulated that their further investigation in the stage III setting might lead to further~     prolongation of survival times. In addition to cisplatin, Irinotecan has been demonstrated to~     act as radiation sensitizers in preclinical and clinical setting. Therefore, their use with~     concurrent radiotherapy might lead to radiation sensitization and improved locoregional~     control.~   "
224474|NCT00620256|"~     The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy~     of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all~     dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular~     hypertension.~   "
224475|NCT00620243|"~     We hypothesize that 18FDG Positron Emission Tomography (FDG PET) imaging, carried out after~     the first cycle of chemotherapy, will identify responders, thus permitting early termination~     of potential toxic therapy in non- responders leading to a significant decrease in morbidity~     and cost. The value of PET imaging as an early predictor of response to chemotherapy has been~     shown in other cancers.~   "
224476|NCT00620230|"~     This study will evaluate the safety and tolerability of single and multiple doses of VAK694~     in healthy volunteers and otherwise healthy volunteers with a history of allergies.~   "
224492|NCT00620022|"~     This study compared the effect of indacaterol (300 μg once daily [od]) on exercise endurance~     with that of placebo in patients with moderate to severe chronic obstructive pulmonary~     disease.~   "
224477|NCT00620217|"~     Achieving therapeutic angiogenesis with gene therapy using a plasmid coding human~     VEGF-A165/bFGF injected into ischemic myocardium of refractory coronary artery disease~     patients, employing a percutaneous catheter-based technique- a double-blind placebo~     controlled study.~      Some patients with persistent coronary artery disease cannot be effectively treated using~     methods available today (no-option patients). It is currently evident that an emerging~     therapy for them might be the stimulation of neoangiogenesis in the area of ischemic~     myocardium using growth factor genes. Agents attracting greatest interest are FGF (fibroblast~     growth factor) and VEGF (vascular-endothelial growth factor). A number of methods have been~     tested to deliver these agents to the area of interest.~      Basic research has revealed that potent forms of angiogenic growth factors are the basic FGF~     (bFGF) and VEGF type A. Most clinical research on therapeutic angiogenesis is done using one~     of these two growth factors. This is to our knowledge the first clinical study using~     bicistronic VEGF-A 165/bFGF plasmid.~      Patient population will comprise CCS III and CCS IV coronary artery disease patients who~     cannot be treated with standard revascularization methods. In the course of study we shall~     attempt to analyze the efficacy of therapeutic plasmid-induced angiogenesis in terms of~     myocardial perfusion increase and clinical symptom improvement. The feasibility and safety of~     plasmid delivery method will also be assessed. A percutaneous catheter-based technique~     (Myo-Star, Johnson & Johnson®) is used for plasmid delivery.~      All patients enrolled will receive optimal medical treatment as judged by treating physician.~     An effort will be made to modify medical therapy during the study course only for clear~     reasons.~      Standard angiography and ventriculography will be performed prior to plasmid injection~     therapy. Ischemic area of interest will be identified on inclusion by SPECT. Cardiac nuclear~     magnetic resonance (cNMR) with adenosine will also be performed to assess heart morphology,~     function and perfusion. Next, injections will be performed according to protocol.~      Follow-up visits will be performed at month 4 and month 12 after injection therapy.~      A change in myocardial perfusion at rest and on dipyridamole-stress SPECT evaluation after~     injection therapy will be the primary measure of efficacy. Changes in exercise tolerance will~     also be monitored along with a number of other efficacy and safety parameters.~   "
224478|NCT00620204|"~     The objective of this study is to evaluate effect of statin treatment for vasospastic angina.~   "
224479|NCT00620191|"~     Hyperinsulinemia and type 2 diabetes (T2D) are important potential risk factors for cognitive~     decline and Alzheimer's disease (AD). Two thirds of the US adult population are at risk for~     hyperinsulinemia and T2D, and half of the population 85 years and older have AD. Peripheral~     hyperinsulinemia can impair the clearance of amyloid beta in the brain, the main culprit in~     AD. Thus, we hypothesize the lowering peripheral insulin in overweight persons with amnestic~     mild cognitive impairment (AMCI), a transition state between normal cognition and AD, can~     decrease the risk of cognitive decline and progression to AD. We propose to conduct a phase~     II double blinded placebo controlled randomized clinical trial of metformin, a safe and~     effective medication that prevents hyperinsulinemia and diabetes, to test this hypothesis~     among 80 overweight persons aged 55 to 90 years with AMCI. The main outcome of the study will~     be changes in performance in a memory test (total recall of the Selective Reminding Test) and~     the Score a test of general cognitive function used in clinical trials (the Alzheimer's~     Disease Assessment Scale-cognitive subscale-ADAS-Cog). . Another aim is to compare brain~     function in an area affected by Alzheimer's disease between the metformin and placebo group~     mean changes from beginning to end among 40 participants using a PET scan.~   "
224480|NCT00620178|"~     This study is a Swedish historical cohort study in patients prescribed Atacand or Cozaar for~     hypertension by selected primary care centres. Data will be extracted anonymously from~     electronic medical records. In addition, data regarding morbidity and mortality will be~     collected by merging the cohort with the following national registries: the Hospital~     Discharge Register (Slutenvårdsregistret), the Cause of Death Register and the Heart~     Intensive Care Admission (RIKS-HIA)~   "
224481|NCT00620165|"~     Essential tremor poses one of the greatest therapeutic challenges to neurologists. This study~     will examine the effectiveness of the drug, levetiracetam or keppra, for the treatment of~     essential tremor.~   "
224482|NCT00620152|"~     In this study, we evaluate whether dietary advice based on two healthy nutritional programs~     can be effectively delivered to families over one month by telephone. We hypothesize that~     among overweight school age children, a one-month telephone intervention will result in~     specific dietary changes consistent with the randomly assigned dietary intervention.~   "
224483|NCT00620139|"~     This pilot study seeks to evaluate the feasibility of measuring the proximal effects of~     concurrent chemoradiotherapy (CRT) on the expression of potential therapeutic target~     molecules in Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, this study proposes~     to evaluate the extent to which CRT induces the differential expression of components along~     two critical, and potentially interdependent, molecular pathways: the arachidonic acid and~     epidermal growth factor receptor (EGFR) signaling pathways.~   "
224484|NCT00620126|"~     The purpose of this study is to determine if home automated telemanagement improves bowel~     symptoms, quality of life, compliance with medications, and health care utilization compared~     to best available care in patients with ulcerative colitis.~   "
224485|NCT00620113|"~     The purpose of this study is to assess the dose-response on the percent change from baseline~     in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when~     odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52~     weeks to Japanese involutional osteoporosis participants. The study will also assess safety~     and tolerability of odanacatib (10, 25, and 50 mg) in these participants.~      The study will enroll approximately 280 participants and randomly assign them to 3 different~     doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium~     carbonate. The primary efficacy hypothesis is that a dose-response relationship on the~     percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50~     mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis~     participants. The primary safety hypothesis is that odanacatib will be safe and well~     tolerated over 52 weeks to involutional osteoporosis participants.~   "
224486|NCT00620100|"~     To determine the Objective Response Rate of 4 cycles of docetaxel + anthracycline (epirubicin~     or doxorubicine) followed by 4 cycles of docetaxel single agent. To determine the Time to~     Tumor Progression (TTP), the Response Duration, the Overall Survival. To confirm the safety~     profile~   "
224487|NCT00620087|"~     We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed~     at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia,~     atypical lobular hyperplasia, or lobular carcinoma in situ.~   "
224488|NCT00620074|"~     This study will test the effectiveness and the safety of giving two antifungal agents~     (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are~     unable to tolerate polyene therapy.~   "
224489|NCT00620061|"~     The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone~     administration in patients with OBD.~   "
224493|NCT00620009|"~     The purpose of the research is to: 1) to test whether psychotherapy including immediate~     feedback of empathy data is more efficacious than therapy without such an exchange of data,~     2) to measure the degree of accuracy of therapist's empathy and its relationship to the~     patient's estimate of the therapist's empathy.~   "
224494|NCT00619996|"~     The purpose of this study is to use Sorafenib plus Docetaxel to evaluate pharmacodynamics~     (PD) in Patients with prostate cancer.~   "
224495|NCT00619983|"~     The purpose of the study is to determine whether the combination of the the three drugs~     gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic~     neuropathy or patients with failed low back syndrome (chronic back pain).~   "
224496|NCT00619970|"~     Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in~     adults, it is one of the functional bowel disorders without a clear framework of~     understanding or an effective treatment. However, new research suggests that small intestinal~     bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of~     symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor~     to IBS in adults, we hypothesize that children with this disorder have a significantly~     greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy~     children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms~     of chronic abdominal pain in children with this condition. To prove this, we will first aim~     to determine the prevalence of SIBO in both healthy children and those with CAP. We will do~     this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive~     measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess~     whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain~     in children with this condition. To do this we will randomize, in a double-blinded fashion,~     the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a~     placebo. After completion of the treatment we will evaluate all these patients for~     eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will~     also assess for symptom improvement by re-administering questionnaires.~   "
224497|NCT00619957|"~     Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men~     with osteoporosis followed by a two year follow-up study.~   "
224498|NCT00619944|"~     With the roll out of antiretroviral therapy (ARV) for HIV across sub-Saharan Africa an~     unprecedented number of people will be commencing lifelong therapy. Current estimates are~     that 5-6 million people in sub-Saharan Africa require ART. At the same time, the World Health~     Organization (WHO) Roll Back Malaria campaign is aggressively promoting the use of~     artemether/lumefantrine as first-line therapy for malaria in this setting. Many patients in~     this setting have already become resistant to first-line ARV and have moved onto~     lopinavir/ritonavir (Kaletra) based second-line regimens. Kaletra is a potent inhibitor of~     Cytochrome P450 3A4 (CYP 3A4), an enzyme responsible for the metabolism of many drugs which~     is found predominantly in the liver and the gut. Lumefantrine, and to a lesser extent~     artemether, is extensively metabolized by CYP 3A4. Therefore when given to a patient already~     taking Kaletra for HIV, it is likely that elevated levels of these drugs in the patient will~     result. There is some concern that lumefantrine may be cardiotoxic due to its structural~     similarity to halofantrine which is known to cause irregular heart rhythms. This has not been~     borne out as yet in any studies performed with lumefantrine, however it is not known what~     levels will be achieved in patients when it is administered with a protease inhibitor such as~     Kaletra. The WHO has not addressed this issue in any of its previous policy documents but has~     identified ARV-antimalarial drug interaction studies as a research priority. This single dose~     pharmacokinetic (PK) study aims to compare the levels of lumefantrine/artemether that result~     when it is given to a patient on Kaletra with patients not on any ARV. Data generated by this~     study will help address this important knowledge gap which has been identified by WHO and~     others as meriting urgent investigation.~   "
224499|NCT00619931|"~     The APD791-002 study is designed primarily to evaluate the safety, tolerability, and~     pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.~   "
224500|NCT00619918|"~     This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of~     viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease~     rate of hospital admission, decrease clinical severity scores, and decrease length of stay.~   "
224501|NCT00619905|"~     This study assessed the long-term safety and tolerability of ACZ885 in patients with~     rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or~     improvement of joint structure and bone mineral density, and long term maintenance of~     health-related quality of life.~   "
224502|NCT00619892|"~     The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR~     (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of~     panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus~     placebo.~   "
224503|NCT00619879|"~     The purpose of this study is to show that myeloablative hematopoietic progenitor cell~     transplantation (HPCT) continues to offer acceptable disease-free survival for select~     patients requiring HPCT.~   "
224504|NCT00619866|"~     This study is designed to see how a research compound (NBI- 56418) works compared to placebo~     (also known as a sugar pill) in women with endometriosis and to see the effect, if any, on~     bone mineral density.~   "
224518|NCT00619684|"~     This phase II trial studies how well lenalidomide works in treating patients with progressive~     or recurrent multiple myeloma after a donor stem cell transplant. Lenalidomide may stop the~     growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the~     immune system in different ways and stop cancer cells from growing.~   "
224530|NCT00619528|"~     The purpose of this study is to attempt to eliminate the necessity of immunosuppressive~     therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor~     hematopoietic stem cell (DHSC) lineages for pairs to demonstrate immunologic~     unresponsiveness, and to investigate the safety and efficacy of the treatment regimen~     including withdrawal of immunosuppression after one year post-transplant for those recipients~     having received DHSC infusions.~   "
224531|NCT00619515|"~     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor~     and cause less damage to normal tissue.~      PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see~     how well it works in treating patients with prostate cancer.~   "
224505|NCT00619853|"~     The purpose of this pilot study was to compare unimanual training (CIMT) and bimanual~     training (HABIT) protocols aimed to improve ability of the involved hand in children with~     hemiplegia. Both protocols were conducted in an educational setting for 2 hours a day for 2~     months, one-hour group session and one-hour individual therapy session conducted by~     occupational therapists or assistants.~      The children in the CIMT group practiced various tasks using their involved hand with the~     contralateral hand constrained with a mitt. The children at the HABIT group practiced various~     bimanual tasks without constraint.~      Twelve children (2 - 6.5 yrs.) participated in this study. The inclusion criterion included~     minimal extension movement of the involved wrist, and for the CIMT group, the ability to of~     tolerates the mitt. The children were matched in relation to cognitive level and MACS score~     and randomly divided into the two intervention groups.~      Each child's assessment included the Quality of Upper Extremity Skills Test (QUEST), the~     Assisting Hand Assessment (AHA), and the Blocks and Box for children above age 5 yrs old.~     Range of motion (ROM) was assessed using an electronic gonimeter, and muscle tone was~     recorded using surface EMG and the Tardiue scale. The Child Health Questioner (CHQ) was~     completed by the parents before, and 6 months after, the intervention. Children were assessed~     starting two month before, and two month after, the intervention.~   "
224506|NCT00619840|"~     Investigation of efficacy and tolerability of extended-release MPD in adults with ADHD,~     compared with a placebo, and to acquire knowledge through long-term observation of adults~   "
224507|NCT00619827|"~     The objective of this study is to assess the effect of grass pollen extract SLIT tablets on~     the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in~     response to grass pollen challenge after one week, one, two and four months of treatment in~     patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.~   "
224508|NCT00619814|"~     The research protocol aim is to compare diagnostic tools for the proper evaluation of patient~     with fecal occult blood test positive (FOBT +), a routine screening test for colorecatl~     carcinoma. The purpose of this study is to determine if Double Contrast Barium Enema (DCBE),~     a specialized radiographic exam of the colon, is a reasonable alternative for the evaluation~     of patients with positive fecal occult blood as compared to colonoscopy, which is considered~     the best evaluation method. Colonoscopy involves the direct visualization of the colon using~     a flexible instrument. This permits the removal of polyps and to obtain biopsies. It involves~     additional risks, discomfort and costs. In fact the DCBE is the experimental procedure in~     this protocol.~      Additional aims of this study are: to determine the localization, number, size and pathologic~     characteristics, if applicable, of findings in colonoscopy and/or DCBE and to determine the~     patient preference between both studies.~      This study is limited to those patients 50 years or older who are at average risk for colon~     cancer and who had a positive fecal occult blood screening test.~   "
224509|NCT00619801|"~     The purpose of this study is to determine the safety of the oral formulation of~     levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis~     or chronic urticaria of unknown origin.~   "
224510|NCT00619788|"~     This investigation is designed to demonstrate the efficacy and safety of the 4.0-5.0mm~     AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use in a~     controlled clinical investigation.~      The scoring balloon is a semi-compliant balloon encircled by 3 spiral struts with a nitinol~     scoring element, which theoretically provides targeted scoring of lesions, by concentrating~     the dilation force thus minimizing barotrauma, elastic recoil and uncontrolled dissection.~     This may improve the outcome of the intervention and reduce the number of stents required.~   "
224511|NCT00619775|"~     Evaluate the safety and efficacy of the Protege Stent and Spider Device in the treatment of~     common and/or internal carotid artery stenoses for subjects that are high risk for carotid~     endarterectomy.~   "
224512|NCT00619762|"~     This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM~     product in three planned analyses. The primary objective of this study is to prospectively~     assess the clinical outcomes associated with the use of LTM in two-stage (expander then~     permanent implant) immediate post-mastectomy breast reconstruction.~   "
224513|NCT00619749|"~     To determine whether fruit juice rich in polyphenols might increase exercise capacity and~     memory in healthy sedentary subjects.Both parameters might be improved because of the~     anti-oxidant effects of polyphenols.~   "
224514|NCT00619736|"~     This study will provide an initial assessment of the safety, tolerability and~     pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to~     healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled,~     inpatient, sequential-group study conducted under fasting conditions at a single~     investigational site. Each subject will participate in only 1 dose group and will receive~     only 1 dose of test article.~   "
224515|NCT00619723|"~     A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial of citicoline~     as an add-on therapy will be conducted in 200 outpatients with bipolar I disorder and cocaine~     dependence. Patients will complete mood and memory assessments weekly, in addition to~     completing self-report measures for cocaine (and other substances, like alcohol) use and~     craving. Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two~     sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically~     designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist~     with experience in CBT. The sessions may be videotaped for training purposes and may be~     viewed by the researchers, the therapist, and Dr. Schmitz, a clinical researcher at the~     University of Texas Houston who is the developer of the CBT for bipolar disorder and~     substance dependence used in the study. Before being videotaped, the patient will sign an~     Authorization for Audio Recordings, Photography, or Other Images for Non-Treatment Purposes~     to further understand how the videotape will be used, and by whom. The patient will be given~     the option to review their videotape to view their therapy session. Once the patient has~     completed all study procedures, or had discontinued the study, the tape will be destroyed,~     until then the tape will kept in the patient's confidential study file. Further, patients~     will return to the clinic three times a week for urine drug tests (UDS). 200 patients are~     expected to be consented for this study and all study procedures will take place at the~     clinic on the University of Texas Southwestern Medical Center campus.~      All non-study medications are not part of the study. Non-study medication will be verbally~     self-reported by the patient at the time of enrollment into the study. The patient will be~     responsible for the costs of their non-study related medications. The patient will manage~     their non-study medications with their personal doctor, including any changes in these~     medications. However the protocol has concomitant medication algorithm in the event that a~     change in the medication schedule needs to be made by a study doctor. If a study doctor~     requests a laboratory test for the patient, it will be paid for by the clinic. Otherwise, the~     patient will be responsible for all costs (including laboratories) associated with their~     non-study medications.~   "
224516|NCT00619710|"~     The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and~     imipenem in hospitalised subjects with complicated skin and skin structure infections.~   "
224517|NCT00619697|"~     This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on~     blood glucose control in type 2 diabetes.~   "
224519|NCT00619671|"~     Myasthenia gravis is a disease that happens because the immune system attacks the nervous~     system. The damage is caused by antibodies produced by B lymphocytes. These antibodies damage~     a special part of the muscle that helps transmit impulses from nerves to muscles to allow~     muscles to work properly. This damage results in symptoms of myasthenia gravis. Participants~     are being asked to participate in this research study because their myasthenia gravis has~     either failed to respond to treatments commonly used in the disease, or they have had bad~     side-effects from such treatments.~      This is a research study of a drug called Rituximab. Rituximab, also called Rituxan, is a~     mouse antibody that has been changed to make it similar to a human antibody. Antibodies are~     proteins that can protect the body from foreign invaders, such as bacteria and viruses, by~     binding to substances called antigens. Rituxan works by binding to a protein, called the CD20~     protein. Rituxan helps to destroy white blood cells that produce antibodies in the body,~     called B-lymphocytes. It is a treatment given through a vein in the participant's arm over a~     period of approximately 4-6 hours. It has been approved by the Food and Drug Administration~     (FDA) for use in patients with a form of cancer of the lymph glands called Non-Hodgkin's~     Lymphoma (NHL). Rituximab is not approved for their myasthenia gravis.~      Treatment with Rituximab is being tried in this research study because Rituximab decreases B~     lymphocytes. There is preliminary evidence that Rituximab helps some patients with chronic~     and otherwise difficult to treat myasthenia gravis.~   "
224520|NCT00619658|"~     To assess the feasibility of using simplified telephone follow-up to predict pregnancy~     expulsion after medical abortion, and if in-person follow-up is required to determine the~     percentage of women that will present for that follow-up.~   "
224521|NCT00619645|"~     Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem~     cell transplant helps stop the growth of cancer cells. It also stops the patient's immune~     system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and~     after the transplant may stop this from happening.~      PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem~     cell transplant together with fludarabine and busulfan and to see how well it works in~     treating patients with hematologic cancers.~   "
224522|NCT00619632|"~     This is a randomized, controlled, single-center, single-blind, 2x2 factorial design trial of~     routine provider, primary care-based interventions to increase breastfeeding intensity up to~     6 months in low-income multiethnic women, with stratification for maternal country of birth.~     The Best Infant Nutrition for Good Outcomes (BINGO) trial will randomize women into one of~     four treatment groups: (a) Prenatal Care Provider (PNC); (b) Lactation Consultant (LC); (c)~     PNC + LC, or; (d) Control. Thus, the separate and synergistic effects of the interventions~     will be tested, compared to a Control standard of care. The intervention and design build~     upon our prior trial of an LC intervention alone.~      PNCs— certified nurse midwives and ob/gyns-- will use a brief, electronically prompted~     protocol with women in the PNC, and PNC + LC groups throughout pregnancy. An LC will arrange~     pre-natal one-on-one meetings, daily hospital, and home visits with women in the LC and~     PNC+LC groups. Descriptive data on infant health visits, and participant/provider experiences~     will be collected as secondary outcomes. Interviews at 1,3 and 6 months post-partum will~     collect infant feeding, and health visit data outside the medical center. Medical center~     visit data will be obtained from MIS data.~      Primary Outcomes (Hypotheses): Breastfeeding~        1. Breastfeeding Intensity at 1,3, and 6 Months~        2. Exclusive Breastfeeding at 1,3, and 6 Months~           Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience~        3. To describe the frequency and timing of infant health visits for breast-feeding~          sensitive illnesses~        4. To describe participant and provider (LC and PNC) experience of the interventions.~   "
224523|NCT00619619|"~     The primary purpose of this study is to test the safety and tolerability of single ascending~     doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent~     outpatients with major depressive disorder. This study will also characterize the~     pharmacokinetic profile of DVS SR in children and adolescents with major depressive disorder.~   "
224524|NCT00619606|"~     A comparative study which compares the end-tidal carbon dioxide and oxygen saturation levels~     of patients during endoscopy which have used either the new oral-nasal oxygenating device~     (TwinGuard), or a standard bite block plus nasal cannulae using an equivalent flow rate of~     oxygen.~   "
224525|NCT00619593|"~     The MADIT-II trial has shown that patients with severely reduced left ventricular ejection~     fraction (LVEF) post myocardial infarction benefit from the implantable~     cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have~     revealed a significantly increased morbidity and mortality in patients with appropriate ICD~     therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality,~     and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD~     therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of~     further clinical diagnostics and therapy in these patients.~      This trial is designed to (i) improve the knowledge of the group characteristics of patients~     suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic~     steps to reduce the mortality of this patient population.~   "
224526|NCT00619580|"~     The information collected will optimize the management of patients with gram negative~     bacteremia. Approximately 300 patients with Gram negative bacteremia are cared for each year~     at UPMC-P. Published medical literature suggests that mortality from this infection exceeds~     20%. The aim of this research is to determine the risk factors for bacteriologic failure of~     antibiotic therapy, risk factors for antibiotic resistance in bloodstream isolates and risk~     factors for mortality from Gram negative bacteremia. Modifiable risk factors can then be~     tackled by a future interventional study.~   "
224527|NCT00619567|"~     There has been little success in treating the cognitive (thinking) problems associated with~     HIV/AIDS using medications. The purpose of this study is to determine whether an~     internet-based cognitive stimulation program might help HIV-infected individuals think more~     clearly. If this is true, then it means that people with mild forms of cognitive impairment~     may be able to help themselves to get better.~   "
224579|NCT00618878|"~     The purpose of the study examines the use of electroacupuncture and laser therapy to treat~     chronic neck pain.~   "
224532|NCT00619502|"~     This is a follow-up of Study A3L10 (NCT00315055)~      Immunogenicity~        -  To describe the antibody persistence following a primary series vaccination of either~          DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.~        -  To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.~      Safety~      - To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.~   "
224533|NCT00619489|"~     This was an open-label study to provide an opportunity for participants with Ulcerative~     Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve~     participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to~     determine the long term safety of vedolizumab in patients afflicted with these diseases.~   "
224534|NCT00619476|"~     The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262),~     hereafter referred to as GEn is effective in the treatment of neuropathic pain associated~     with post-herpetic neuralgia (PHN).~   "
224535|NCT00619463|"~     The purpose of the study is to determine the efficacy of aerobic exercise for improving~     cognition, mood, and fatigue after Traumatic Brain Injury (TBI) as well as examine the role~     of Brain Derived Neurotropic Factor (BDNF) and peripheral Vascular Endothelial Growth Factor~     (VEGF) as mediators of response to exercise.~   "
224536|NCT00619450|"~     The purpose of this study is to determine the optimal images of the heart structures which~     are used to guide AF ablation or BiVenticle and coronary vessels.~   "
224537|NCT00619437|"~     Genetic etiology in schizophrenia is widely accepted. However, many chromosomal sites were~     shown to characterize the families of patients with schizophrenia. This is probably due to~     the high genetic heterogenity of this illness. Thus, it is important to investigate the~     genetic factor in relatively genetically homogenous populations. Many studies have indicate~     that Ashkenazy Jews show relative gentic homogenity. Indeed, the genes responsible for most~     Mendelian disorders of Jewish peoples have been identified. The study will apply genome-wide~     mutation screening methods to identify candidate allells in subjects of Ashkenazi Jewish~     ancestry with multiplex schizophrenia.~   "
224538|NCT00619424|"~     This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and~     tolerability and to determine the maximum tolerated dose (MTD) of pazopanib in combination~     with erlotinib (Arm A) or pazopanib in combination with pemetrexed (Arm B) in patients with~     advanced solid tumors. Patients will be enrolled in cohorts of 3 (in each arm) to receive~     escalating doses of pazopanib and erlotinib or pazopanib and pemetrexed. Dose escalation~     schemas for each study arm are described in the protocol. For each arm, the MTD regimen will~     be defined as the highest dose combination of the agents where no more than one out of six~     patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm~     will be studied with the MTD regimen to evaluate toxicity and pharmacokinetics. In arm A~     (erlotinib), a run-in phase with each drug separately will allow an evaluation of~     pharmacokinetics with each drug separately and also for the two drugs in combination. This~     will allow an assessment of potential drug-drug interactions. Pharmacokinetic endpoints will~     be AUC, Cmax, tmax and t1/2 of pazopanib, erlotinib, and pemetrexed, as well as pemetrexed~     clearance before and after administration of pazopanib in the extension cohort of Arm B.~     Antitumor activity will be assessed using RECIST criteria.~   "
224539|NCT00619411|"~     The purpose of this study is to examine the feasibility and acceptability of an adaptation of~     Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) that includes greater and more~     structured involvement of the parents in the treatment.~   "
224540|NCT00619398|"~     This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf®~     in stable liver transplantation patients. It shall be demonstrated that FK506MR is~     non-inferior to Prograf® with regards to the efficacy and safety.~   "
224541|NCT00619385|"~     Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg~   "
224542|NCT00619372|"~     This clinical study is designed to evaluate the safety of oral administration of the study~     drug anti CD3 (OKT3) in combination with β-D glucosylceramide [GC] .~   "
224543|NCT00619359|"~     The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to~     prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin~     chemotherapy.~   "
224544|NCT00619346|"~     This is a phase 1 study to establish the safety and tolerability profile of pafuramidine~     maleate 100 mg BID administered orally for 14 days to healthy subjects~   "
224545|NCT00619333|"~     The aim of the study is to investigate whether inactive FSH plays a role in the development~     of Premature Ovarian Failure in women with Classic Galactosemia~   "
224546|NCT00619320|"~     This study will examine safer sex skills building (SSB), a targeted behavioral HIV prevention~     and risk reduction group intervention in two samples of pregnant drug abusing women.~   "
224547|NCT00619307|"~     To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in~     patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected~     interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while~     receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence~     of flu-like symptoms.~   "
224548|NCT00619294|"~     Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia~     in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA).~     CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG).~     Digital reactive hyperemia peripheral arterial tonometry (RH-PAT) provides noninvasive~     evaluation of endothelial dysfunction. The investigators hypothesized that the fingertip~     RH-PAT could predict the presence of CSA in women.~   "
224549|NCT00619281|"~     Low output syndrome is a common complication in patients undergoing cardiac surgery. Its~     incidence was reported to be 2 to 6% [1]. Morbidity and mortality of low output syndrome is~     high and the costs for treating the disease are immense.~      The primary objective of this prospective observational study is to define a threshold for a~     critically reduced cardiac output requiring immediate therapy.~   "
224550|NCT00619268|"~     The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a~     combination of Torisel® and Avastin® given at first-line treatment in patients with~     metastatic renal cancer.~      Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®,~     or Sutent® or IFN+Avastin®.~   "
224551|NCT00619255|"~     Recent needs assessments suggest that difficulties exist in care coordination between~     emergency medical services (EMS) systems and primary care for injured adolescents with~     alcohol problems and post-traumatic stress disorder (PTSD). This project will implement,~     evaluate, and disseminate the adolescent trauma support service model program that aims to~     enhance coordination between EMS systems and primary care/community services.~   "
224552|NCT00619242|"~     To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe~     is important in the progression of cancer.~   "
224553|NCT00619229|"~     Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering~     from dry age-related macula degeneration~   "
224554|NCT00619216|"~     Liver transplant patients often require multimodal immunosuppressive therapy to minimize~     their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower~     the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up~     to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of~     patients have intolerance to MMF, thereby mitigating our ability to use this agent. The~     primary objective of this study is to assess the tolerability of myfortic in combination with~     Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after~     conversion from MMF in maintenance liver transplant patients with GI intolerance within 3~     months.~   "
224555|NCT00619203|"~     Bacterial meningitis remains a significant cause of morbidity and mortality in children,~     especially in countries with limited resources. Efforts to improve the grim outcome have~     included altering the first line antibiotic therapy, controlling seizures and managing fluids~     more carefully. Adjuvant therapy of steroids has been used with limited success in children~     in the West and with no proven value in Malawi and other resource constrained settings.~     Glycerol has been used to reduce brain oedema in neurosurgery and it has recently been shown~     to reduce morbidity in childhood meningitis in South America. Paracetamol in a high dosage~     has been shown to reduce inflammation and cytokine levels in septicaemia with improved~     outcomes in adults.~      In Malawi the investigators have tried adjuvant steroids with no improvement in outcome of~     childhood meningitis. They have recently concluded a study of ceftriaxone which has shown no~     improvement in mortality though there is less hearing loss than with chloramphenicol and~     benzyl penicillin.~      Following the encouraging results of the Childhood South American Study it is important to~     assess the use of adjuvant glycerol in children in the investigators' setting. Paracetamol is~     routinely used in meningitis because of the accompanying fever and headache. This is an~     opportunity to study its place as adjuvant therapy more carefully than has previously been~     done.~      The investigators propose a prospective, randomized, double blind 2 by 2 factorial designed~     study to assess the advantage of ceftriaxone (antibiotic) given with paracetamol and glycerol~     in combination, singly or with neither adjuvant therapy in childhood bacterial meningitis.~   "
224556|NCT00619190|"~     The purpose of this open label study in children and adolescents is to examine the acute and~     long-term effects of aripiprazole on problem behaviors associated with autism spectrum~     disorders and development in areas which appear to be affected by autism spectrum disorders.~   "
224557|NCT00619177|"~     The objective of the observational study is to examine the effect of MOVALIS (Meloxicam)~     therapy on Health Related Quality of Life (HRQoL) in the diverse region of Central and~     Eastern Europe. The Medical Outcomes Study 12 Item Short Form Health Survey version 2~     (SF-12v2) will be used as the instrument to measure any change in physical wellbeing~     (Physical Component Summary, PCS) and mental wellbeing (Mental Component Summary, MCS) of~     patients following MOVALIS (Meloxicam) therapy.~   "
224558|NCT00619164|"~     The purpose of this study is to assess the safety and tolerability of E5555 in Japanese~     patients with acute coronary syndrome.~   "
224559|NCT00619151|"~     The purpose of this study is to compare the sizing and implant techniques between the~     CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.~   "
224560|NCT00619138|"~     The purpose of this study is to compare a stepped care model for the treatment of social~     phobia and panic disorder with standard psychological treatment. The stepped care model~     comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program,~     12 weeks individual cognitive-behavioural therapy. Patients are assessed at each step and~     taken out of the study if they show significant clinical improvement and follow for 12~     months. Patients are randomized to either the stepped care model or standard psychological~     treatment, i.e. individual cognitive-behavioural therapy. All treatment components are~     manualized.~   "
224561|NCT00619125|"~     Purpose: The associations between pain, stress, bloating, and their short interval temporal~     relationships to defecation in IBS D, C & M are of great interest to the field of functional~     GI disorders, but have not been adequately studied. Broad recall based assessments (i.e.,over~     past week or month) of pain and bloating have been key features of the diagnosis of IBS,~     however such long term retrospective recall of symptom experience has been shown to be~     unreliable and influenced by outside factors (heuristics, recall bias, etc.). Short interval~     assessment may provide a more accurate picture of patient symptom experience Participants:~     Patients with IBS in general and IBS subtypes (IBS-C, D, M) Procedures (methods): Study~     participants could be asked to record data at randomly assigned points throughout the day, as~     well as during the course of a diarrheal or constipated stool (i.e., prior to and right after~     a bowel movement).~   "
224562|NCT00619112|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients~     with recurrent high-grade glioma.~   "
224563|NCT00619099|"~     The purpose of this study is to determine the effectiveness and safety of two different dose~     schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes~     (MDS).~   "
224564|NCT00619086|"~     We evaluated the effects of giving a single dose of steroid before thyroid surgery in a~     single institutional, double-blinded, randomized controlled trial. Postoperative nausea,~     pain, and vocal function were significantly improved after steroid administration compared to~     controls.~   "
224580|NCT00618865|"~     Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients~     with major depressive disorder during pregnancy and breast-feeding.~   "
224565|NCT00619073|"~     Clopidogrel is a medication that is used to decrease the ability of platelets to form blood~     clots.~      The theory has been proposed that, in patients with coronary artery disease or stroke,~     increased platelet function after discontinuation of clopidogrel therapy is associated with~     an increased clotting risk. However, this theory has never been rigorously tested.~      The goal of this research is to determine whether discontinuation of clopidogrel results in~     increased platelet function.~   "
224566|NCT00619060|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of topical myristyl nicotinate cream may stop skin cancer from forming.~      PURPOSE: This randomized phase I trial is studying the side effects and best way to give~     topical myristyl nicotinate cream on the skin of healthy volunteers.~   "
224567|NCT00619047|"~     Osteoporosis has been established as a major public health problem, primarily effecting~     women. The attainment of maximal peak bone mass is crucial in the prevention of osteoporosis,~     yet little is known about the specifics of bone accrual. Physical activity has been~     identified as an important modifiable factor controlling bone accrual. It is has been shown~     that increased activity during peri-pubertal years increase bone mineral content during~     adulthood. Thus, strategies designed to increase peak bone mass should target the~     peri-pubertal years of critical bone acquisition.~      Hypothesis 1a: The amount of bone mineral accrued during the peri-pubertal years is greater~     in girls who engage in impact activity than in those who do not.~      Hypothesis 1b: The positive effects of impact activity on bone accrual are maintained after~     cessation of the activity, resulting in greater bone mineral density in girls who participate~     in impact activity during a portion of the peri-pubertal years than in those who never~     participated in impact activity.~   "
224568|NCT00619034|"~     The purpose of this study is to determine if diabetic retinopathy can be treated with~     prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases~     inhibitors.~   "
224569|NCT00619021|"~     RATIONALE: Bronchial artery infusion uses a catheter to deliver antitumor substances directly~     to the lungs. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Giving gemcitabine in different ways~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given~     by bronchial artery infusion and to see how well it works in treating patients with recurrent~     or progressive non-small cell lung cancer.~   "
224570|NCT00619008|"~     The purpose of this study is to test the hypothesis that a low-carbohydrate diet will impact~     hormones and other factors that regulate appetite and energy balance, and result in lower~     energy intake and greater weight loss, than a high complex carbohydrate diet.~   "
224571|NCT00618995|"~     The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER~     niacin, laropiprant, and placebo over the course of seven days on urinary levels of a~     specific metabolite (which is a marker of in vivo platelet reactivity).~   "
224572|NCT00618982|"~     Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of~     advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib~     works by stopping the development of new cancer cells and new blood vessels. By stopping the~     growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth~     of kidney cancer tumors.~      This is an open-label study which means that the patient, the doctor and Bayer Healthcare~     will know what tablets the patient is taking. All patients in this study will receive~     sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day).~     Treatment with sorafenib will continue until the patient's tumor grows larger or spreads~     further or if the patient has intolerable side effects. The dose of sorafenib that the~     patient will receive in the study will increase at certain points during the patient's~     treatment, as long as the patient is not experiencing side effects and the patient's tumor~     has not grown.~   "
224573|NCT00618969|"~     The purpose of this study is to transplant haploidentical related peripheral blood stem cells~     (PBSCs) that come from a relative such as a parent, sibling, a child or other relative who~     has a half-matched tissue type with the recipient (rather than being completely matched)~     following administration of a reduced-intensity regimen of busulfan, melphalan and~     alemtuzumab.~   "
224574|NCT00618956|"~     The study is designed to accurately assess any changes in blood pressure and pulse at 100 and~     200 mg daily dose of milnacipran in patients with fibromyalgia syndrome.~   "
224575|NCT00618943|"~     This research aims to identify efficacious strategies for treating tobacco dependence among~     adolescent smokers with co-occurring psychiatric disorders. Adolescent smoking remains a~     significant public health issue with 23% of high school students reporting smoking a~     cigarette in the past month1. Smoking rates are two to four times higher among adolescents~     with psychiatric disorders such as attention deficit disorders, conduct disorder, depression,~     anxiety disorders, and alcohol and illicit drug dependencies2-4.~      Empirical investigations of adolescent tobacco treatment interventions number less than 50~     with many of the studies criticized for methodological problems (i.e., follow up < 6 months,~     poor retention, lack of control or comparison groups)2,5, 6. There have been no unequivocal~     successes; however, promising interventions include stage-based, cognitive behavioral (CBT),~     and multicomponent treatments2, 7. Additionally, the nicotine patch is well tolerated and~     safe among adolescents8 and rarely abused9. Less than a third of adolescent tobacco users~     report intention to quit in the near future2, 10, 11; thus, it seems critical that cessation~     interventions for this complex group be designed to assist smokers at all stages of readiness~     through the quitting process. A stepped care approach has the potential of matching more~     intensive services to those ready for and in need of greater treatment. Interventions~     delivered in health care settings have the appeal of broad reach.~      The primary specific aims of this research are to evaluate, in a randomized clinical trial~     (N=160), the efficacy of a stepped care intervention for treating smoking among adolescents~     recruited from outpatient psychiatry settings. To our knowledge, this would be the first~     study to examine outpatient psychiatry settings for treating tobacco dependence in~     adolescents. The stepped care intervention combines expert-system contacts, individual CBT~     sessions, and 12-weeks of nicotine replacement therapy (NRT).~   "
224576|NCT00618930|"~     The patients are assigned by randomisation on one of the two laxatives. After cleansing they~     have to fill in an evaluation form to report their findings and difficulties. Also the~     surgeon will be asked to fill in a score-form to report all details concerning the bowel~     preparation.~   "
224577|NCT00618917|"~     This is a Phase I-II study evaluating the feasibility, safety, and efficacy of swallowed~     MnSOD plasmid/liposome (PL) transgene given as protection against radiation-induced~     esophagitis during concurrent paclitaxel and carboplatin chemotherapy with thoracic radiation~     in subjects with locally advanced non-small cell lung cancer (NSCLC).~   "
224578|NCT00618904|"~     To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve~     gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.~   "
224582|NCT00618839|"~     This pilot Phase I/II clinical study will be conducted at up to three clinical sites.~      This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients,~     each with skin defects. The patients are intended to undergo sequential surgical procedures~     involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at~     various separate or contiguous wound sites. Patients will be randomized within each wound~     site to one of two test products: cadaver skin or StrataGraft™ skin tissue.~   "
224583|NCT00618826|"~     The purpose of this study is to look at a new chemotherapy schedule in metastatic breast~     cancer.~   "
224584|NCT00618813|"~     This clinical trial is studying the side effects of combination chemotherapy and to see how~     well they work in treating patients with newly diagnosed localized Ewing sarcoma family of~     tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) and giving the drugs in different ways may kill more tumor cells.~   "
224585|NCT00618800|"~     The objective of the proposed study is to reduce the incidence of falls and fall-related~     injuries among community-dwelling older adults by better utilizing community pharmacists to~     advise patients and physicians on medication management.~   "
224586|NCT00618787|"~     This is a multi-center, prospective, randomized, double blind, pilot clinical trial of~     subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA~     AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic~     wounds.~   "
224587|NCT00618774|"~     To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients~     with essential hypertension who failed to control their BP with either monotherapy~   "
224588|NCT00618761|"~     The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic~     clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney~     recipients and normal controls as well as with the partially previously reported data in~     beta-cell recipients.~   "
224589|NCT00618748|"~     To assess the efficacy and safety of olanzapine in the long-term treatment for patients with~     bipolar I disorder, depressed.~   "
224590|NCT00618735|"~     The purpose of the study is to see if daily and twice daily administration of BIIB021 is~     tolerated in patients with advanced solid tumors.~   "
224591|NCT00618722|"~     To evaluate the safety and potential efficacy of deoxycholic acid injection compared to~     placebo for the reduction of submental fat (fat below the chin).~   "
224592|NCT00618709|"~     The purpose of this research is to evaluate the safety and pharmacokinetic profile of single~     doses of ATX-101~   "
224593|NCT00618696|"~     RATIONALE: Monoclonal antibodies can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Radioactive monoclonal antibodies, such as~     yttrium Y 90 monoclonal antibody, can find cancer cells and either kill them or carry~     cancer-killing substances to them without harming normal cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of a yttrium Y 90~     monoclonal antibody and how much radiation is taken in by the organs in the body in treating~     patients with advanced leukemia or other hematologic disorder.~   "
224594|NCT00618683|"~     The purpose of this study is to determine/identify what mechanisms/factors are involved with~     regard to AV nodal reentrant tachycardia.~   "
224595|NCT00618670|"~     The purpose of this study is to examine the effects of a home-based exercise rehabilitation~     program compared to a supervised exercise program on intermittent claudication (leg pain or~     discomfort) and ambulatory function.~   "
224596|NCT00618657|"~     This phase II is studying the side effects and how well carboplatin and paclitaxel~     albumin-stabilized nanoparticle formulation when together with bevacizumab or trastuzumab~     before surgery works in treating patients with stage I-III breast cancer. Drugs used in~     chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as bevacizumab and trastuzumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Giving more than one drug (combination chemotherapy) and monoclonal antibody therapy together~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed.~   "
224597|NCT00618644|"~     The purpose of this study is to determine the ocular and non-ocular safety of a single dose~     of ranibizumab in treating neovascularization secondary to sickle cell retinopathy.~   "
224598|NCT00618631|"~     Background:~        -  Tobacco smoking is one of the most preventable causes of morbidity and mortality in the~          world, but the addictive property of nicotine is such that fewer than 10 percent of~          people who attempt to quit smoking remain tobacco-free after 1 year. Researchers are~          studying the addictive properties of nicotine in an attempt to develop more successful~          medication therapies for smoking cessation.~        -  Nicotine acts on chemical receptors in the brain, including opioid receptors that affect~          the perception of pain. Repeated nicotine administration can cause adaptations in the~          brain s opioid receptors, which heightens the addictive properties of nicotine and~          increases the likelihood and severity of withdrawal symptoms associated with smoking~          cessation. Researchers are interested in using positron emission tomography (PET)~          scanning to study brain chemical responses to nicotine in current smokers and~          nonsmokers.~      Objectives:~        -  To study brain chemical activity related to cigarette smoking and nicotine~          administration.~        -  To compare the brain chemical activity of current daily smokers with that of nonsmokers.~      Eligibility:~      - Individuals 21 to 50 years of age who are either current smokers (10 to 25 cigarettes daily~     for at least 2 years) or have had some exposure to tobacco but have never smoked regularly~     (may have had a maximum of 20 cigarettes in their lifetime and none in past year).~      Design:~        -  Eligible participants will undergo initial medical and psychological screening and~          neuropsychological testing before beginning the main phase of the study. Participants~          will be required to abstain from alcohol and drugs (except caffeine, nicotine, and~          prescription drugs) for 24 hours before each session, and smokers will refrain from~          smoking after midnight on the night before each session.~        -  Session 1: Participants will answer questions about nicotine craving and withdrawal~          symptoms, followed by a magnetic resonance imaging (MRI) scan to provide baseline~          information about brain activity.~        -  Session 2 and 3: Participants will answer questions about nicotine craving and~          withdrawal symptoms, and then will smoke one cigarette (either active nicotine or~          placebo). Researchers will document participants consumption of the cigarette. After the~          cigarette is smoked, participants will have a PET scan. Blood samples will be drawn~          during the PET session.~   "
224599|NCT00618618|"~     Phase 2 trial to evaluate the safety and potential efficacy of one concentration of~     deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the~     reduction of submental fat (fat beneath the chin).~   "
224600|NCT00618605|"~     Successful control of the HIV epidemic will require a safe and effective vaccine to be~     developed. A successful vaccine will need to stimulate a widespread immune response. The~     purpose of this study is to determine the safety of and immune response to an adenovirus~     serotype HIV vaccine in HIV uninfected adults.~   "
224601|NCT00618592|"~     The recent development of an oral carbohydrate drink for consumption prior to elective~     surgical procedures has been shown to improve insulin sensitivity. However, these studies~     have not investigated the use of this carbohydrate supplement in patients undergoing cardiac~     and spinal surgery.~      Hypothesis: The administration of 100g of carbohydrates the evening before and 50g of~     carbohydrates two hours before elective coronary artery bypass graft (CABG) or spinal surgery~     will reduce postoperative insulin resistance by 40% compared to those undergoing the standard~     of care of fasting the evening before and the day of surgery.~   "
224602|NCT00618579|"~     Administration of LMWH in healthy male subjects treated with TB-402 and administration of~     TB-402 in healthy male subjects treated with warfarin~   "
224603|NCT00618566|"~     More women with disabilities (30%) report feelings such as sadness, unhappiness, or~     depression that prevent them from being active compared to women without disabilities (8%).~     The contexts of the lives of WPD, which often include high rates of poverty, architectural~     and attitudinal barriers, and higher vulnerability to violence and abuse, contribute to this~     mental health disparity. To help address this disparity, the overall goals of this pilot~     study are to: 1)1. Develop a cognitive behavioral group therapy intervention to address the~     specific needs of WPD who experience depressive symptoms; and 2. Pilot-test the intervention~     to preliminarily evaluate its efficacy using a mixed-methods approach. The proposed and~     revised study outcomes were derived from our previous work with WPD as well as from feedback~     obtained from community meetings conducted since our last submission of this proposal. A~     pilot of the modified intervention with a total of 90 participants will be conducted using a~     using a wait list control design. The decision to use a wait list control design was made~     jointly with our community partners to ensure that all WPD participating in the study have~     access to the intervention.~   "
224604|NCT00618553|"~     The goal of this clinical research study is to see if pulmonary rehabilitation can improve~     patients' lung function, which would increase their chances of becoming eligible for surgery.~     The health of pulmonary rehabilitation participants after surgery will also be examined.~   "
224605|NCT00618540|"~     RATIONALE: Giving a monoclonal antibody, such as alemtuzumab, and chemotherapy drugs, such as~     fludarabine and melphalan, before a donor stem cell transplant helps stop the patient's~     immune system from rejecting the donor's stem cells and helps stop the growth of abnormal~     cells. When the healthy stem cells from a donor are infused into the patient they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may~     stop this from happening.~      PURPOSE: This phase II trial is studying how well giving alemtuzumab together with~     fludarabine and melphalan followed by a donor stem cell transplant works in treating young~     patients with resistant Langerhans cell histiocytosis.~   "
224606|NCT00618527|"~     The purpose of this trial is to examine the benefits of early combination of CellCept® with~     Rebif® in long-term management of patients with multiple sclerosis. Quantitation of mRNA for~     MxA gene from ex-vivo lymphocytes obtained from patients receiving both drugs or interferon~     alone will be used to gauge the usefulness of this combination therapy. In addition we will~     examine the safety of combination of mycophenolate mofetil and interferon beta 1a in~     treatment of multiple sclerosis.~      This is a pilot study to examine if the combination of CellCept® with Rebif® will prove to be~     useful in the early treatment of patients with MS. Up-regulation of the MxA gene following~     the administration of Rebif® will be used as a surrogate marker of interferon bioactivity.~     This in turn could serve as a surrogate marker of interferon efficacy in these patients.~      The null hypothesis is that there will not be any difference in the proportion of patients~     that produce MxA gene transcripts in the Rebif® group as compared to the group that received~     Rebif® with CellCept® at the end of this study (1 year).~      The alternate hypothesis is that the combination of CellCept® with Rebif® will prove to be~     useful in prolonging the efficacy of interferon. In other words, the combination will result~     in a significant proportion of patients in the treatment group continuing to produce MxA as~     compared to the proportion of patients producing MxA in the Rebif® arm.~   "
224607|NCT00618514|"~     This trial was designed as a prospective, multi-center, randomized clinical trial of the~     FDA-cleared Vari-Lase Bright Tip Fiber compared to commercially available standard bare-tip~     laser fiber (control) to demonstrate the safety and effectiveness of laser ablation for the~     treatment of varicose veins associated with reflux within the great saphenous vein (GSV) and~     to provide additional data concerning patient satisfaction. Within this evaluation, subject~     limbs were randomized to one of two (2) treatment groups utilizing a 1:1 randomization ratio.~     If a subject required treatment of only one limb, that limb was randomized to a treatment~     group. If a subject required treatment of two limbs, the first limb was randomly assigned~     treatment and the second limb was assigned the other treatment (the opposite treatment of the~     other limb). The data was analyzed by treated limb (versus treated subject).All study data~     were analyzed under the principles of intent-to-treat, in which data are analyzed according~     to the assigned randomized group regardless of the treatment actually delivered. Subjects~     were followed at one week, one month, and six months.~   "
224608|NCT00618501|"~     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of~     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. Imatinib mesylate may also stop the growth of cancer cells by blocking the enzymes~     necessary for cancer cell growth. When the healthy stem cells from a donor are infused into~     the patient they may help the patient's bone marrow make stem cells, red blood cells, white~     blood cells, and platelets. It is not yet known which treatment regimen is most effective in~     treating acute lymphoblastic leukemia.~      PURPOSE: This phase II trial is studying the side effects of giving imatinib mesylate~     together with combination chemotherapy with or without a donor stem cell transplant and to~     see how well it works in treating patients with newly diagnosed acute lymphoblastic leukemia.~   "
224609|NCT00618488|"~     The purpose of this study is to determine if probiotics bacteria, specifically~     bifidobacterium lactis (BB12) improve gastrointestinal symptoms in subjects with functional~     gastrointestinal symptoms (i.e., non-patients IBS/functional bowel disorders).~   "
228550|NCT00565487|"~     The primary purpose of this study is to determine the best dosage of Capecitabine and Tarceva~     combination in the setting of radiation and to assess treatment effectiveness,~     progression-free survival and overall survival.~   "
224610|NCT00618475|"~     Depression is second in frequency only to hypertension as a comorbid condition for End Stage~     Renal Disease (ESRD) patients. The presence of depression has been linked to lower quality of~     life, more medical comorbidities and shorter lifespan. This project represents the first~     known attempt at a standardized intervention for depression in ethnically diverse ESRD~     patients. The study will be conducted at the Parkside Center for Dialysis. Patients will be~     randomly selected for screening until 80 subjects meet entry criteria and agree to be~     randomized. Once subjects are screened and enrolled in the study they are randomly assigned~     to either a treatment or wait-list control condition. After 3 months, the intervention will~     be completed and both groups will be reassessed. After an additional 3 months, both groups~     will have received the intervention and pre and post measures for both groups will be~     available as well as 3 month follow-up for the 1st intervention group.~      The following measures will be collected: to obtain a full DSM-IV diagnosis the SCID I and~     SCID II will be utilized. The BDI will provide a self-report measure of depression. The~     Hospital Anxiety and Depression Scale (HADS), a measure designed specifically for medically~     ill patients, will also be administered. Additionally, the Young Schema Questionnaire, a~     measure which seeks to identify maladaptive (both depressive and anxious) cognitive styles,~     will be administered. A quality of life measure designed specifically for dialysis patients~     (KDQOL-SF) will also be given as a means of measuring patient's overall coping and~     functioning. To better understand the patient's perceptions of their health and illness the~     Illness Effects Questionnaire will be administered. A demographic information sheet will be~     completed by the subject in which personal, ethnic, and illness information is collected.~     Detailed information about the subject's mental health history and treatment as well as~     current medications will be gathered. Data from routine dialysis laboratories (hemoglobin,~     creatinine, albumin, Kt/V) will be extracted from the chart.~      The intervention will take place in individual format while the subjects are being dialyzed.~     The intervention will be 10 sixty minute -long weekly sessions spread over not more than 3~     months. It will include both cognitive and behavioral skills focused on alleviating~     depressive affect and identifying maladaptive patterns of thought and behavior. This study~     would lay the groundwork for future clinical research by helping to develop a culturally~     competent clinical intervention and demonstrate the feasibility and effectiveness of adapting~     psychosocial intervention for a medically complex culturally diverse population.~   "
224611|NCT00618462|"~     This study will determine the effectiveness of three different treatment strategies in~     reducing gambling behaviors in pathological gamblers.~   "
224612|NCT00618449|"~     Trachoma is a disease of poverty, which in the hyperendemic areas affects all individuals by~     the time they are two years old. Active disease is concentrated in children and occurs~     sporadically in adults. Infection is more widespread. It is anticipated that 25% of the~     children will be blinded by this disease if they live to be 60 years of age. The blindness~     rates are higher in women, presumably because of their closer contact with children who can~     infect them and add to damage from infections the women had while young.~      This proposal is to better define how azithromycin in community-based treatment can be used~     to eliminate blinding trachoma. We will also take the opportunity to join these field studies~     with genetic epidemiologic studies to better understand the dynamic epidemiology of Chlamydia~     trachomatis infection in a trachoma endemic area. The empiric data generated from the~     treatment/follow-up studies, together with the information on sources and spread patterns~     from genetic epidemiology will be used to generate more robust models to guide future~     treatment/re-treatment protocols.~      We propose to conduct a randomized, community based trial in the Maradi region of Niger to~     test the hypothesis that two community wide azithromycin treatments, spaced one month apart,~     are significantly more effective in reducing ocular C. trachomatis infection and trachoma at~     one year compared to a single mass azithromycin treatment.~   "
224613|NCT00618436|"~     To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in~     patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared~     to the current standard of care anticonvulsant and will be at least as effective as the~     current standard of care in preventing clinical and sub-clinical seizure activity.~   "
224614|NCT00618423|"~     After a surgical operation, patients may suffer from chronic pain. Ketamine, a well known~     anesthetic acts on receptors in the spine (NMDA receptors), which are implied in the~     occurrence of chronic pain. The mechanism is called central sensation. It is known that~     Ketamine reduces immediate postoperative pain, but its effectiveness in the prevention of the~     chronic pain is still unknown. The investigators study will follow patients until one year~     after operation for the occurrence of chronic pain. The investigators hypothesis is that~     Ketamine reduces significantly chronic postoperative pain after major back surgery and~     improves patient outcome.~      There may be important inter-individual differences how persons react on a drug. These~     differences are partly determined by the genes of each individual. The investigators study~     includes therefore a genetic analysis.~      Psychological and social factors also influence the perception of pain. It is still not well~     understood who these psychosocial factors determine the appearance and perception of~     chronic pain. In the investigators study the investigators will therefore study these factors~     by questionnaires.~   "
224615|NCT00618410|"~     The purpose of this study is to better understand the way in which CO2 (carbon dioxide)~     affects the symptoms of allergic rhinitis or hayfever.~      Our intent is to determine if CO2 has an effect on nasal challenge with antigen as a~     predictor of whether it will have a beneficial effect on the treatment of seasonal allergic~     rhinitis.~   "
224616|NCT00618397|"~     Opioids, such as fentanyl, are commonly used in PICU patients to provide comfort and pain~     control. Opioid tolerance, the need to increase the dose of medication to achieve the same~     effect,is seen in PICU children who require opioid infusions. Animals and human studies have~     shown that activation of the N-methyl-D-aspartate (NMDA) receptor is involved in the~     development of opioid tolerance and that deactivation of this receptor can slow the~     development of tolerance. Ketamine, an NMDA receptor antagonists, turns off the NMDA~     receptor. Ketamine is used to provide sedation and anesthesia in children. Its use in~     inhibiting the development of opioid tolerance has not been tested in children. We aim to~     determine ketamine's effectiveness in the treatment of tolerance in PICU patients who require~     fentanyl infusions to treat pain and discomfort .~      Some physicians have reported using ketamine doses of 0.04mg/kg/hr to 0.5mg/kg/hr to inhibit~     opioid tolerance. We propose to study the sedative effect, and the metabolism of, three doses~     of ketamine, 0.1mg/kg/hr, 0.3mg/kg/hr, and 0.5mg/kg/hr.~      Patients admitted to the PICU, requiring a breathing machine and fentanyl infusion for~     discomfort or pain control will be enrolled. Patients' age three to eighteen years will be~     enrolled. Patients will receive a ketamine infusion once their COMFORT scores indicate an~     adequate sedation/comfort level on their current sedation regimen. The COMFORT score is a~     validated scale that measures distress in PICU patients. The COMFORT score will be continued~     for the twelve hours the patient receives the ketamine to test whether the ketamine adds to~     the level of sedation. Blood samples during and following the ketamine infusion will be taken~     to determine how ketamine and norketamine (one of ketamine's metabolites) are used in the~     body.~      To determine the effect of ketamine on tolerance it must be a ketamine dose that does not~     cause additional sedation. The goal of this study is to define a non-sedating dose of~     ketamine and define how it is used by the body. A non-sedating ketamine dose could be added~     to current sedation regimens allowing us to monitor the development of tolerance without the~     confusion of added sedation. The data obtained in this study will be used to design a study~     to further investigate the effect of ketamine on opioid tolerance.~   "
224617|NCT00618384|"~     For patients with advanced HCC not suitable for resection or liver transplantation but~     without extrahepatic manifestations, local therapy with TACE is regarded as standard~     treatment. The present study is planned to evaluate the combination of TACE and sorafenib. A~     combination of TACE with a multitarget inhibitor like sorafenib may further improve the~     outcome of patients with HCC.~   "
224632|NCT00618163|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam~     tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fasting conditions~     using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
224618|NCT00618371|"~     The medicines used to treat HIV can suppress but cannot kill all the virus in the body. A~     small amount of virus remains at low levels in the part of the blood called the plasma. It is~     of crucial importance to identify the source of the residual virus in patients receiving~     antiretroviral therapy. The purpose of this study is to investigate whether the source of low~     level plasma virus is from latent (old) infection or ongoing (new) infection. MK-0518 is a~     investigational drug, which means that is not yet FDA approved, that works in a different way~     to other anti-HIV medicines to help kill the virus. We hypothesize that addition of MK-0518~     to a stable anti-HIV regimen will reduce the viral load further in patients with undetectable~     plasma virus.~   "
224619|NCT00618358|"~     Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared~     with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients~     undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including~     extra-anatomic, infrainguinal bypass and arteriovenous (AV) access procedures).~      Study Design: The study is a multi-center, prospective, randomized controlled clinical trial~     that will compare two methods for treating anastomotic leakage (bleeding). All subjects (n~     =151) will be randomized at a 3:1 ratio to receive either the investigational treatment~     (Vascular Sealant) or the control treatment (Gelfoam/Thrombin). Up to two (2) treatment sites~     may be evaluated for each subject. Subjects will be stratified by type of graft procedure: AV~     access graft or extra-anatomic and infra-inguinal graft. A minimum of 60 patients, and a~     maximum of 91 patients, will be enrolled in each stratum. Treatment randomization will be~     blocked by center and type of graft procedure (e.g., bypass or AV grafts). All subjects will~     undergo preoperative screening to determine eligibility and will be evaluated~     intraoperatively, at discharge or within 7 days of surgery, and 30 days post-procedure to~     monitor for hematologic disturbances, hemorrhagic events, wound complications and other~     potential acute post-operative adverse events.~      Up to ten (10) investigational sites will participate in the study. Enrollment is expected to~     take approximately 8 months for an anticipated duration of the clinical investigation of~     approximately 9 to 10 months.~      The primary objective of this trial is to demonstrate non-inferiority of the Vascular Sealant~     to Gelfoam/Thrombin when used to seal anastomotic suture lines in patients undergoing~     placement of PTFE vascular grafts (including extra-anatomic, infrainguinal bypass and~     arteriovenous access procedures).~   "
224620|NCT00618345|"~     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the cancer.~      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with~     relapsed or refractory multiple myeloma.~   "
224621|NCT00618332|"~     We hypothesize that those patients with purely seasonal allergic rhinitis will decongest~     better than those subjects with another cause contributing to their symptoms. These latter~     patients will not improve as well on an intranasal steroid as those who decongest well,~     potentially explaining the 60% response rate in prior studies.~   "
224622|NCT00618319|"~     This study will examine the effect of BIIB021 on GIST growth and metabolism.~   "
224623|NCT00618293|"~     Evaluation of efficacy by determination of transfusion requirements and safety by~     determination of adverse events in administration of Von Willebrand factor concentrate F VIII~     (Haemate).~   "
224624|NCT00618280|"~     In the present study, we investigate healthy subjects and schizophrenic patients who~     frequently show very low attentional capacity with functional magnetic resonance imaging~     (fMRI) and electrophysiology (EEG) during attention-requiring tasks to assess the level of~     attentional network activity.~   "
224625|NCT00618267|"~     The purpose of this study is to see if we can find a new way to test how certain Multiple~     Sclerosis (MS) medications work in the body and to better understand how the medicines change~     certain substances (cells) found in the immune (protective) system.~      Blood test will be drawn by doing the following:~        -  Use a new method called the Immuknow® Test to see if this method will help to better~          understand how MS medicines work.~        -  Measure certain levels of immune cells in a new way, to see if it this will help to~          understand the body's response to MS medicines.~      These methods will test those with MS who are not taking any MS medications, to help us~     compare the results.~      About 100 subjects will be enrolled in this study at the Partners Multiple Sclerosis Center~     at Brigham and Women's Hospital. Biogen Idec, Inc. of Cambridge, MA, is paying for this study~     to be done.~   "
224626|NCT00618254|"~     The objective of this study was to assess bioequivalence of a potential generic 1 mg~     granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet,~     Kytril, following a single 1 mg dose, under fasting conditions.~   "
224627|NCT00618241|"~     The purpose of this study is to determine whether interactions between raltegravir and~     lamotrigine take place and to study the safety of the combination raltegravir/lamotrigine~     before used in HIV patients.~   "
224628|NCT00618228|"~     The objective of this study was to assess bioequivalence of a potential generic 750 mg~     balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg~     balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting~     conditions.~   "
224629|NCT00618215|"~     Background: Routine oral examination (ROE) refers to periodic monitoring of the general and~     oral health status of patients. In most developed Western countries a decreasing prevalence~     of oral diseases underpins the need for a more individualised approach in assigning recall~     intervals for regular attendees instead of systematic decision making of fixed intervals.~     From a quality of care perspective as well, one can also question the effectiveness of the~     widespread prophylactic removal of mandibular impacted asymptomatic third molars (MIM) in~     adolescents and adults. It is as yet unclear how quality of oral care can be improved.~     Research data on effectiveness of interventions to promote continuing professional~     development for dentists are rare.~      Methods/Design: This implementation study is a cluster randomised controlled trial with~     groups of GDPs as the unit of randomisation. The aim of the study is to determine the~     effectiveness and efficiency of small group quality improvement on professional decision~     making of general dental practitioners (GDPs) in daily practice. Six peer groups~     ('IQual-groups') shall be randomised either to the intervention group I or group II. Groups~     of GDPs allocated to either of these arms act as each other's control group. An IQual peer~     group consists of 8-10 GDPs who attend in monthly structured sessions scheduled for~     discussion on practice related topics.~      GDPs in both trail arms receive recent developed evidence-based CPG on ROE or MIM~     respectively. The implementation strategy consists of 1 interactive IQual circle meeting of~     mostly 2-3 hours. In addition, both groups of GDPs receive feedback on personal and group~     characteristics and are invited to make use of web-based patient vignettes for further~     individual training on risk assessment policy. A few weeks after the interactive meeting~     reminders (flow charts) will be send by mail.~      The main outcome measure for the ROE-study and control group is the use and appropriateness~     of individualised risk assessment in assigning recall intervals and for the MIM-study the use~     and appropriateness of individualised mandibular impacted third molar risk management.~      Measurements (pre-intervention data collection) will take place in months 1-3, starting in~     September 2006. Post-intervention data collection will be performed after 9 months.~      Discussion: In most developed Western countries a decreasing prevalence of oral diseases~     underpins the need for a more individualised approach in assigning recall intervals for~     regular attendees. If the evaluation of this multifaceted implementation study reveals a~     shift in individual performance of GDPs in assessing risks for oral disease, further research~     questions and efforts to a risk-based professional education could be promoted.~      Scientific hypothesis Multifaceted implementation of consensus based clinical practice~     guidelines (CPGs) for GDPs on ROEs and the management of asymptomatic impacted third molars~     (MIM) in daily dental practice is more effective and efficient compared to only dissemination~     of CPGs.~   "
224630|NCT00618202|"~     The objective of this study was to assess the bioequivalence of a potential generic 750 mg~     balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg~     balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under~     fasting conditions.~   "
224633|NCT00618150|"~     Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit~     from an educational program explaining the medical aspects of the disease, self-management~     strategies and how to deal with health services. We hypothesized that patients having~     participated in an educational program would experience an improved quality of life when~     compared to patients who did not take part (controls).~   "
224634|NCT00618137|"~     The main objective of the study is the exploration of the natural course of COPD and its~     biological background. To this end, active workers without COPD and workers in functional~     classes GOLD 0-III are investigated by a combined clinical and molecular approach. The study~     has been designed as a prospective, intraindividual pilot in 160 male or female volunteers of~     the greater Vienna Area over a period of three years for each individual volunteer.~   "
224635|NCT00618124|"~     This study assesses the maximum tolerated dose, overall safety and antitumor activity of~     SU011248 in combination with capecitabine in patients with advanced solid tumors~   "
224636|NCT00618111|"~     The objective of this study was to assess bioequivalence of a potential generic 1 mg~     granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet,~     Kytril, following a single 1 mg dose, under fed conditions.~   "
224637|NCT00618098|"~     The purpose of this study is to determine whether Octaplex (human prothrombin complex~     concentrate) can reverse the effects of anticoagulants when compared to the standard~     treatment of fresh frozen plasma (FFP).~   "
224638|NCT00618085|"~     Motor imagery is a technique widely used in learning skills. Its effectiveness has been~     proven in various sports and in musicians. A recent review (Braun et al. 2006) suggested that~     this technique may also be effective in rehabilitation of patients with neurological disease~     or damage, but that further research was needed.~      The main purpose of this research is to discover whether motor imagery practice is beneficial~     in the rehabilitation of skills in patients who have some disability due to neurological~     disease or damage. The principal research question is: are physiotherapy and occupational~     therapy given incorporating motor imagery more effective than standard care (i.e., the same~     therapies but without integrated motor imagery) in re-training task specific performance for~     patients with neurological disease or damage?~   "
224639|NCT00618072|"~     The goal of the study is to identify and treat women with midlife weight gain who have normal~     blood sugars, but increased insulin levels (hyperinsulinemia) following the performance of a~     glucose tolerance test. The study will evaluate effects of a unique carbohydrate modified~     diet alone and in combination with metformin(MF) and Avandamet® (MF plus rosiglitazone (RSG))~     on insulin levels in a wide range of ethnically diverse women (aged 35-55) at three academic~     medical centers. The primary study hypothesis is that insulin sensitizing medications, in~     combination with alterations in carbohydrate intake, will reduce insulin levels and improve~     established risk factors for the metabolic syndrome.~      The alarming prevalence of obesity, diabetes, and related comorbidities and the paucity of~     easily adopted, cost-effective preventive strategies for high risk populations, suggest that~     pharmaco-therapies and dietary regimens targeted to reducing insulin resistance could have~     important clinical and public health implications.~   "
224640|NCT00618059|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine~     tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fed conditions using a single-dose,~     randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
224641|NCT00618046|"~     The objective of this study was to assess bioequivalence of a potential generic 600 mb~     oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine~     tablet, Trileptal, following a single 600 mg dose, administered with food.~   "
224642|NCT00618033|"~     This study aims to show that using a glucose (sugar) concentration of 100 mg/dL in the~     dialysis fluid for hemodialysis is not inferior to using a concentration of 200 mg/dL with~     regard to the frequency and magnitude of blood glucose drops. Other parameters that will be~     compared between the two groups are blood pressure, heart rhythm, weight gain between~     dialysis treatments, and fatigue after the treatment.~   "
224643|NCT00618020|"~     The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety~     and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary~     arteries.~   "
224644|NCT00618007|"~     To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving~     metformin~   "
224645|NCT00617994|"~     This will be an open label study of INCB018424 topical cream applied to 2 - 20% BSA in~     patients with active, stable plaque psoriasis.~   "
224646|NCT00617981|"~     The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal~     doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when~     used in conjunction with radiofrequency ablation (RFA).~   "
224647|NCT00617968|"~     Primarily to evaluate the rates of clinical and radiological response in the 2 groups.~     Secondarily rate of histological response.~   "
224648|NCT00617955|"~     The dept. of Anesthesiology currently has a database of subjects whom had surgery and~     received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is~     more harmful than Amicard. In an effort to see what the long term outcomes were for subjects~     whom had surgery here at Upstate, it was decided to look at long term death rates to see if~     any differences. A student t-test will be used to determine statistical significance where a~     p value of <0.05 will be deemed significant. Using data from 462 subjects that had undergone~     cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality~     rate from the Mangano, et.al. publications, the unadjusted mortality for the two drugs are~     Aprotinin 5.4% and Amicar 1.2%. A power analysis was performed using the hospital mortality~     rates of 5.4% and 1.2% with the sample size in the propensity data and a p-value of 0.05. The~     result was a power of 81.7%.~   "
224649|NCT00617942|"~     Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable~     and unresectable HER2+ (stage IIa-IIIb) breast cancer~   "
224661|NCT00617786|"~     This is a prospective study. Subjects will be recruited from the urology practices of Dr. Ken~     Peters and Dr. Ananias Diokno at William Beaumont Hospital. Subjects will be referred to the~     study by the clinician recommending Sacral NeuroModulation therapy (SNM).~      This pilot study is to explore the effect of SNM on sensory pathways by measuring CPT values~     pre and post SNM treatment.~   "
224650|NCT00617929|"~     RATIONALE: Antithymocyte globulin, clofarabine, and rituximab may stop the patient's immune~     system from rejecting the donor's stem cells when they do not exactly match the patient's~     blood. The donated stem cells may replace the patient's immune cells and help destroy any~     remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a~     donor can also make an immune response against the body's normal cells. Giving antithymocyte~     globulin before transplant and cyclosporine and mycophenolate mofetil before and after~     transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with~     clofarabine and rituximab works in treating patients after an unsuccessful stem cell~     transplant.~   "
224651|NCT00617916|"~     This study is designed to test a prototype imaging instrument that relies on Medical~     HyperSpectral Imaging (MHSI) technology for the assessment and prediction of diabetic foot~     ulceration and wound healing. The imaging system utilizes the biomarkers of oxyhemoglobin~     (oxyHb) and deoxyhemoglobin (deoxyHb), in the upper layers of skin on the foot as: a metric~     for assessing wound healing, a reflection of microvascular disease, and determining tissue at~     risk for forming new ulcers. MHSI results will also be compare with ABI and TcPO2~     measurements.~   "
224652|NCT00617903|"~     This exploratory study is being performed to determine whether a new form formulation of~     azelaic acid 15% is effective in the treatment of papulopustular rosecea.~   "
224653|NCT00617890|"~     Participants with relapsed osteosarcoma that can be treated with surgery will be randomized~     to robatumumab administered intravenously (IV) at one of two dose levels. These participants~     will first receive robatumumab, have surgery performed, and continue to receive treatment~     every two weeks until a year of dosing, or until disease progression.~      Participants with unresectable osteosarcoma or Ewing Sarcoma will receive robatumumab IV once~     every two weeks until disease progression. Participants who achieve a complete response (CR)~     or partial response (PR) after tumor evaluations may undergo surgical resection. After~     surgery, participants are eligible to receive 10 mg/kg robatumumab until disease~     recurrence/progression or one year of total dosing, whichever occurs first.~   "
224654|NCT00617877|"~     The purpose of this study is to evaluate the antihypertensive response of treatment with~     losartan with reference to genetic polymorphisms.~   "
224655|NCT00617864|"~     This research study was designed to look at the effect of human albumin transfusion on~     circulating levels of Vascular Endothelial Derived Growth Factor (VEGF), a protein that is~     believed to be responsible for the syndrome of ovarian hyperstimulation. Patients have been~     asked to participate because they are identified as at risk for the Ovarian Hyperstimulation~     Syndrome (OHSS), a potentially serious complication of in vitro fertilization. It has been~     established that the onset of OHSS may be preventable by the infusion of albumin at the time~     of egg retrieval; however, we do not know by what mechanism albumin works. As we know the~     pathogenesis of OHSS is related to VEGF released from the ovaries, we believe human albumin~     may serve to bind up this VEGF and prevent it from causing its harmful effects. The purpose~     of this study is to evaluate the effect of albumin infusion on blood and urine VEGF levels in~     these patients.~   "
224656|NCT00617851|"~     The purpose of this research is to demonstrate immunologic equivalence of three consecutive~     production lots of the subunit influenza vaccine compared to egg-derived inactivated~     influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to~     show how safe and well tolerated a conventional inactivated subunit influenza vaccine,~     licensed in many countries outside the United States, is compared to an inactivated influenza~     vaccine, licensed in the United States.~   "
224657|NCT00617838|"~     Celiac disease is an autoimmune disease induced by wheat gluten. Destruction of epithelial~     cells and microvilli on gut mucosa is causing a flat mucosa and an absorption defect. The~     diagnosis is based on typical microscopical finding in biopsy specimens but serum antibodies~     to tissue transglutaminase and certain gliadin peptides are strongly associated with the~     pathology. Severe diarrhoea associated with growth disturbance in infancy was historically~     characterising the disease but is nowadays rare. Clinically more mild forms including silent~     disease are very common. Studies based on antibody screening and biopsies done in~     autoantibody positive subjects have confirmed a frequency of about 1-2% in adult population.~     Undiagnosed disease is associated with deficiencies of nutrients and vitamins leading to~     various chronic symptoms like anaemia, osteoporosis and general fatigue. It has also been~     recently found that undiagnosed celiac disease may be associated with general~     underachievement in society probably associated with common psychological symptoms like~     fatigue and depression during the adolescence. The disease is treated by complete elimination~     of wheat, rye and barley in the diet, which is laborious and causing considerable extra costs~     in nutrition.~      Much progress has been recently made in understanding of the genetic background and immune~     markers associated with the disease as well as in understanding those patterns of gluten~     introduction in infancy, which might be connected to a high disease risk. Our aim in this~     study is in the first phase to identify children at high genetic risk (around 10%) and in a~     follow-up study to define:~        1. Are the age, dose of gluten and presence of simultaneous breast feeding at the~          introduction of gluten associated with the risk of celiac disease?~        2. Is it possible to decrease the frequency of celiac disease by nutritional counselling?~        3. Is it possible to predict development of celiac disease by immunological tests before~          the development of mucosal lesion~      If we can confirm, that optimising the conditions at the introduction of wheat gluten in~     infancy diet significantly reduces the disease incidence, will this have an important effect~     on the nutritional recommendations concerning the diet in infancy. Combining genetic~     screening and immunological tests might also offer a way to reduce the frequency of celiac~     disease and help in early diagnosis and organisation of an adequate treatment~   "
224658|NCT00617825|"~     Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and~     poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized~     and under-treated disorders shat harm the veins of the legs and at worst, cause skin~     inflammation and venous leg ulcers. A new way to ease the pain and inflammation is proposed~     in this study of cryotherapy (cool gel wraps) applied to damaged skin of the lower legs of~     CVD-affected individuals. The study hypothesis predicts that this novel cryotherapy model and~     method will significantly improve the health and quality of life for those with CVDs and that~     the intervention will become a standard of care for CVDs. In addition, the method will, over~     time, reduce health care costs associated with treating poor CVD outcomes.~   "
224659|NCT00617812|"~     The purpose of this study is to evaluate the safety and immunogenicity of an indigenously~     developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib)~     combination vaccine in healthy Indian infants as a part of the routine immunization in~     accordance with the EPI schedule.~   "
224660|NCT00617799|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is looking at biomarkers that predict response to high-dose~     aldesleukin in patients with metastatic kidney cancer or metastatic melanoma.~   "
224662|NCT00617773|"~     RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying how well Hu3S193 works in treating patients with~     ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.~   "
224663|NCT00617760|"~     The purpose of this study in healthy toddlers who have not previously been immunized against~     MenC infection and who completed their primary immunization series with PCV-7 (3~     vaccinations) during infancy is to demonstrate that the concomitant administration of a~     single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to~     the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone,~     and does not influence the immune response to the MenC-TT vaccine as compared to~     administration of MenC-TT vaccine alone.~   "
224664|NCT00617747|"~     The purpose of this study is to evaluate the effectiveness and tolerability (the ability not~     to experience ill effects from the study drug) of a zolmitriptan nasal spray, 5.0 mg,~     compared with placebo (inactive drug) for 2 migraine headaches for up to 12 weeks in adult~     subjects with migraine headaches~   "
224665|NCT00617734|"~     The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab~     (Erbitux®) can increase the time prior to disease progression in participants with Squamous~     Cell Head and Neck Cancer who have had disease progression and platinum-containing~     chemotherapeutic regimen.~   "
224666|NCT00617721|"~     Purpose: Identification of the gene(s) involved in plasma membrane remodelling.~     Identification of the circulating markers affected by the defective membrane remodelling in a~     collection of families with unexplained provoked hemorrhages and evaluation of their~     prognosis value in the assessment of the hemostatic cellular response.Hypothesis: Scott~     syndrome is rare a familial disorder characterized by provoked haemorrages in homozygous-type~     patients due to isolated membrane remodelling deficiency. Membrane remodelling is necessary~     for cellular hemostatic responses.~   "
224667|NCT00617708|"~     This randomized phase I/II trial is studying the side effects and best dose of monoclonal~     antibody therapy when given together with gemcitabine hydrochloride and erlotinib~     hydrochloride and to see how well they work compared with giving gemcitabine hydrochloride~     and erlotinib hydrochloride alone as first-line therapy in treating patients with metastatic~     pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as~     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. Giving erlotinib hydrochloride and gemcitabine hydrochloride together with~     monoclonal antibody therapy may kill more tumor cells.~   "
224668|NCT00617695|"~     The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig)~     nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a~     3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches~   "
224669|NCT00617682|"~     The main objective of this study is to evaluate whether immunization with 9-valent~     pneumococcal conjugate vaccine (PNCRM9) during the third trimester of pregnancy interferes~     with active antibody production in offspring immunized with PNCRM7 (Prevnar) in the first six~     months of life.~   "
224670|NCT00617669|"~     Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054~     (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone~     resistant prostate cancer (HRPC).~      This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can~     further improve survival compared with docetaxel alone.~      ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread~     by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054~     (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with~     docetaxel.~      All patients participating in this clinical trial will receive docetaxel chemotherapy, which~     is a commonly used chemotherapy to treat prostate cancer in addition to other existing~     prostate cancer therapies.~      Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive~     placebo in addition to docetaxel and other prostate cancer therapy. By participating in this~     trial there is a 50% chance that patients will receive an agent that may further slow the~     progression of the tumour.~      No patients will be deprived of standard prostate cancer therapy.~   "
224671|NCT00617656|"~     Primary objective:~      · Time to progression.~      Secondary objectives:~        -  Assess Overall survival of both treatment groups.~        -  Assess Tumor response rate using RECIST criteria~        -  Assess Toxicity profile of patients enrolled in the study.~        -  Exploratory evaluation of potential genetic markers of response or resistance to~          chemotherapy.~   "
224682|NCT00617500|"~     The alternative and complementary therapies are being gradually included in the Brazilian~     Health Unique System (SUS), as it is foreseen in the National Politics of Integrative and~     Complementary Practices in Brazil . However, though this thematic is also included in the~     National Agenda of Research Priorities concerning Health, published studies concerning this~     matter are quite scarce. The World Health Organization (WHO) indicated that it is a big~     challenge to effect the following studies: cost-effectiveness, as well as safety, efficiency~     and the quality of such practices. WHO also pointed out the clinical situations where they~     could be applied and that is why this investigation we are undertaken is fully justified.~      Annoying signs and symptoms which come along with the climacteric period, especially anxiety,~     insomnia and hot flushes, change women´s life quality and their affective, social and~     business relationships as well. Consequently, this can generate sadness, depression and~     isolation.~      Many women cannot undergo hormonal replacement, for several reasons: or they have some~     illnesses which reject hormones, or due to hypersensitiveness reactions or even economical~     difficulties. Also, the cost-effectiveness ratio between conventional therapy of hormonal~     replacement and complementary therapies which compose this study are not known yet .~      The complementary therapies proposed in this study concern non-invasive methods, of low cost,~     which justify being researched in order to verify the potential of those annoying signs~     alleviation.~   "
224672|NCT00617643|"~     Triomune is the most commonly prescribed treatment for HIV infection in Uganda. Triomune is~     manufactured by a generic drug company and consists of three drugs combined in a single pill~     given twice daily (stavudine 30mg plus lamivudine 150mg plus nevirapine 200mg).~      It is known that the levels of nevirapine in a patient's blood are highest in the first two~     weeks of treatment. Therefore it is recommended that patients starting on nevirapine should~     undergo dose escalation i.e start on 200mg once daily for two weeks and then increase to full~     dose of 200mg twice daily in order to avoid nevirapine related rash. It is not possible to do~     dose escalation with a fixed dose combination pill like Triomune and for the two weeks of the~     dose escalation patients either can buy stavudine plus lamivudine plus nevirapine as separate~     pills or take Triomune in the morning and then take stavudine plus lamivudine as separate~     pills in the evening.~      Rifampicin is used to treat TB and lowers the levels of nevirapine in a patient's blood. This~     raises two questions in routine clinical practice for patients who are co-infected with HIV~     and TB (1) Do we need to put our patients to the trouble of dose escalation of nevirapine if~     they are already on rifampicin? and (2) If we dose escalate nevirapine in patients on~     rifampicin, are we putting them at risk of low drug levels and development of resistance? The~     aim of this study is to compare the plasma concentrations of nevirapine in HIV infected~     patients who are commencing antiretroviral therapy with and without a lead in dose of~     nevirapine and who are also receiving concomitant treatment with antituberculous therapy~     which includes rifampicin to assess whether dose escalation of nevirapine is appropriate in~     this patient population~   "
224673|NCT00617617|"~     The purpose of this research study is to determine if giving men with early stage (Grade 1-2)~     prostate cancer dietary supplement from soybeans called isoflavones, will change their blood~     hormone levels. Isoflavones are substances found in a high concentration in soybeans that are~     converted in the intestines to hormone-like compounds which are similar to estrogen. They are~     also thought to have cancer fighting properties. Clinical trials suggest that isoflavones can~     increase certain sex hormones, which results in the slower production of prostate cancer~     cells. This study will determine if adding isoflavones (supplied as Prevastein HC®) 80 mg/day~     in a pill form can change your risk factors that cause early stage prostate cancer to~     progress to more advanced disease.~   "
224674|NCT00617604|"~     The purpose of this study is to determine whether alefacept is effective and well tolerated~     when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a~     combination therapy of placebo, tacrolimus and steroids in the prevention of kidney~     transplant rejection.~   "
224675|NCT00617591|"~     The purpose of the research study is to determine the response rates when Revlimid® is~     combined with Doxil® and Dexamethasone (Dd-R) in newly diagnosed Multiple Myeloma. The study~     will also evaluate the side effects caused by the combination of these three drugs. This~     therapy is investigational in the treatment of Multiple Myeloma.~      Revlimid® is a drug that alters the immune system and it may also interfere with the~     development of tiny blood vessels that help support tumor growth. Therefore, in theory, it~     may reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug~     Administration (FDA) for specific types of myelodysplastic syndrome (MDS) and Multiple~     Myeloma, two different types of blood cancer. It is currently being tested in a variety of~     other cancer conditions. In this case it is considered experimental.~      Doxil® is a form of chemotherapy. It is approved by the FDA for the treatment of relapsed/~     refractory Multiple Myeloma in combination with Velcade.~      Dexamethasone is a steroid. It is also approved by the FDA, but not for the treatment of~     Multiple Myeloma. It is considered a standard part of most myeloma therapies for newly~     diagnosed patients.~   "
224676|NCT00617578|"~     Many arrhythmias detected in the ventricular fibrillation (VF)-zone picture monomorphic~     ventricular tachycardia (VT) and, hence, could be terminated by antitachycardia pacing (ATP)~     treatment. Advantages of successful ATP are the painlessness termination and the shortened~     duration of arrhythmia. The ATP One Shot algorithm is integrated in the latest family of~     implantable cardioverter defibrillators (ICDs) from BIOTRONIK (Lumax). It allows a single~     delivery of ATP before charging capacitors to terminate lethal arrhythmia by painful shock.~      The present study evaluates the efficacy of the ATP One Shot algorithm for the termination of~     fast VT episodes. 200 patients with secondary prophylactic ICD indication will be followed~     for 18 months. Spontaneous episodes detected in the VF-zone of the ICD will be evaluated with~     regard to cycle length, episode duration and course of device therapy.~   "
224677|NCT00617565|"~     This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of~     biphasic insulin aspart 30 on postprandial glycaemic control.~   "
224678|NCT00617552|"~     The purpose of this study is to determine whether TZP-101 is effective in the management of~     post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large~     bowel resection).~   "
224679|NCT00617539|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with~     temozolomide and to see how well it works in treating patients with breast cancer who have~     received previous treatment for brain metastases.~   "
224680|NCT00617526|"~     The primary objective of the trial is:~      • to evaluate the change from baseline in plasma viral load with placebo and one of up to 4~     dose regimens of RDEA806.~      The secondary objectives are:~      Efficacy~        -  to describe the nadir of the plasma viral load~        -  to describe the DAVG~        -  to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log,~          or reach an undetectable viral load~        -  to assess the plasma viral load decay rate~        -  to evaluate immunologic changes (as measured by CD4 and CD8 cells)~        -  to evaluate the genotypic and phenotypic pattern of the virus Pharmacokinetics~        -  to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of~          RDEA806 Safety~        -  to evaluate the safety and tolerability of bid and qd dosing of RDEA806 as monotherapy~   "
224681|NCT00617513|"~     The purpose of this study is to determine which dose of prucalopride is safe and effective in~     patients with chronic idiopathic constipation.~      Hypothesis:~      Prucalopride 1 and 2 mg are safe and effective for the treatment of chronic idiopathic~     constipation whereas 0,5 mg is a suboptimal dose.~   "
224683|NCT00617487|"~     The purpose of this study is to evaluate the role of stress echocardiography, compared to~     standard echocardiography in the early identification of pulmonary arterial hypertension in~     systemic sclerosis. To evaluate the role of BNP in this setting.To analyze data recorded with~     respect to the parameters commonly used for SSc evaluation (eg thorax HRCT, pulmonary~     function tests + DLCO, nailfold capillaroscopy, etc); these parameters are available starting~     for 1999.~   "
224684|NCT00617474|"~     The study hypothesis is that erythropoietin usage after kidney transplantation, in early~     phase, can improve the outcome for patients and their graft increasing patient and graft~     survival.~   "
224685|NCT00617461|"~     The purpose of this study is evaluate the difference between two doses of gabapentin~     enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with~     post-herpetic neuralgia.~   "
224686|NCT00617448|"~     The objective of this prospective randomised trial was to compare the short- and long-term~     efficacy of conventional diathermy haemorrhoidectomy versus Ligasure™ diathermy, and to~     assess the short-term outcome of each procedure performed either under spinal anaesthesia or~     local anaesthesia with pudendal block with ropivacaine combined with intravenous sedation.~      We think, Ligasure haemorrhoidectomy under local anesthesia can be performed as day-case~     procedure and with equal results at long-term than conventional diathermy (considered goal~     standar of haemorrhoidectomy).~   "
224687|NCT00617435|"~     The investigators' project has as for principal objective to understand the impact of trans~     fatty acids from dairy products and industrial origin on the development of insulin~     resistance in obese woman. Because of the different isomeric position of the double bound~     those trans fatty acids may have different metabolic effects.~   "
224688|NCT00617409|"~     The purpose of this research study is to test a tumor (cancer) vaccine given along with~     chemotherapy to determine if this vaccine will increase the chances of the tumor shrinking~     and/or the amount of time that people who have this disease will live.~   "
224689|NCT00617396|"~     Purpose: We are proposing to examine, via open label trial, the use of Seroquel® for patients~     with moderate to severe functional bowel symptoms who are not receiving adequate relief from~     their symptoms on their present regimen of SNRI or TCA antidepressant agents.~      Participants: Primary eligibility will be determined of patients at The UNC Center for~     Functional GI & Motility Disorders Clinic who score in the moderate to severe range on the~     Functional Bowel Disorders Severity Index (FBDSI ≥ 37) who have failed or have incomplete~     treatment responses of medications including at least one prior trial of antidepressant~     medication.~      Procedures (methods): We will monitor several patient and symptom related outcomes, as well~     as evaluate health related quality of life, psychological distress and related psychosocial~     measures to determine if the addition of Seroquel® over and above the use of an~     antidepressant improves clinical response based on an adequate relief measure as well as~     selected secondary outcomes. We will also determine when treatment benefit is related to~     effects on pain, the associated psychological co-morbidities seen in this population, or both~     factors.~   "
224690|NCT00617383|"~     The definition of the most 'at-risk' population within highly susceptible groups would~     provide an opportunity for preemptive therapeutics.~      A convenient, safe, and tolerable therapy that delays the onset of clinical disease during~     the pre-symptomatic stage of demyelinating disease would provide a therapeutic alternative to~     a 'wait and see' approach in subjects at 'high risk' for CIS (clinically isolated syndrome -~     monosymptomatic demyelinating disease) or MS.~      Identical twins share the same genes and have the highest rate of shared MS. An identical~     female with a sister twin with MS has a 34% chance of having MS. Non concordant (no MS yet)~     identical (monozygotic - from the same sperm-egg zygote) female twins provide an ideal~     population to find out what factors predict the onset of MS in the non-affected twin.~      We will recruit 30 identical female twins, one with MS and the other without MS, and obtain~     brain MRI and biological samples on the non-affected twin and determine if:~        -  the presence of characteristic MS-like lesion(s) on baseline MRI predisposes to MS.~        -  specific proteins in blood or cerebrospinal fluid predispose to the clinical expression~          of demyelinating disease~      If we can predict by simple tests (MR brain scan and blood tests) the likelihood of the onset~     of MS in 'at risk' subjects, and have safe and tolerable therapies, we may be able to prevent~     the clinical onset of demyelinating disease (MS).~   "
224691|NCT00617370|"~     The purpose of this study is to give a drug regimen that is hoped to be effective in~     preventing cancer from coming back. Since it is an aggressive breast cancer, there is a~     moderate to high chance that the cancer may come back. The standard treatment for this tumor~     type includes a chemotherapy regimen with drugs named epirubicin (E) and cyclophosphamide (C)~     in a vein every 2 weeks for 4 treatments, followed by a drug named paclitaxel, every 2 weeks~     in your vein for 4 treatments.~      This study is an experimental study in which you will be given 6 cycles of EC followed by 6~     cycles of paclitaxel. The purpose of getting 2 more cycles of EC and 2 more cycles of~     paclitaxel than what is normally given is to study a regimen that may be more effective than~     the current standard treatment in preventing the recurrence of this cancer. Specifically, in~     this study we are looking for side-effects and risks of these drugs as more cycles are given.~   "
224692|NCT00617357|"~     This is a prospective, multicenter, interventional, observational, open label, single arm,~     longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or~     infected sites. Three interim analyses are planned to examine the incidence of surgical site~     events, postoperative resumption of activities and hernia recurrence.~   "
224693|NCT00617344|"~     This is a follow up study using three different formulations for each serotype with the aim~     of testing immunogenicity and reactogenicity~      Primary Objective:~      Immunogenicity: To evaluate immunogenicity by neutralizing antibody response post dose 2.~      Secondary Objectives:~      Safety: To evaluate safety following three formulations of ChimeriVax™ Tetravalent Dengue~     Vaccine.~      Immunogenicity: To describe the neutralizing antibody responses after each dose.~   "
224706|NCT00617175|"~     To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered~     for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a~     consequence of self-termination and better arrhythmia discrimination due to a greater number~     of R-R intervals necessary to detect ventricular events.~   "
228551|NCT00565474|"~     Principal objective is to investigate if the treatment with fluvastatin can prevent the~     progression of vascular graft disease in de novo renal transplant patients.~   "
224694|NCT00617331|"~     The purpose of this research study is to determine whether prior exposure to A/H2N2 viruses~     is associated with better antibody (part of the immune system that fights infection)~     responses after vaccination with an A/H9N2 flu vaccine. The study will evaluate how much~     antibody is made to the influenza virus after H9N2 flu vaccination and how the body reacts to~     different strengths of the H9N2 flu vaccine. This information may guide vaccine development~     for this virus as well as other bird flu viruses that have infected humans. Study~     participants will include 120 healthy subjects, age 18-38 or 44-59 years. Two different~     dosages of vaccine will be given in the muscle of the upper arm about 1 month apart. The~     assignment of vaccines to participants is governed by chance. Study procedures may include~     medical history, physical exam, and blood samples. Study participation duration is about 7~     months.~   "
224695|NCT00617318|"~     Pomegranate has a long history of use in folk medicine. There is vast data on the health~     benefits of pomegranate fruit and juice. Multiple studies have established the strong~     antioxidative effects of pomegranate polyphenols (primarily the ellagitannin punicalagin) and~     their health effects. A vast number of animal and human clinical studies have provided~     evidence on effect of pomegranate products on improving blood lipid profile, reducing blood~     pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic~     activity. We studied the protective effect of a pomegranate concentrate (POM Flu and Cold~     Formula®) in decreasing the incidence and duration of influenza-like illnesses and common~     cold among healthy adults.~   "
224696|NCT00617305|"~     To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other~     hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase~     type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who~     have demonstrated a sub-optimal response to PDE-5i monotherapy.~      The study was originally designed as a 2-arm, double-blind, randomized study in which~     patients received ambrisentan or placebo for 24 weeks, and then received ambrisentan blinded~     to dose for 24 weeks. With Protocol Amendment 2 (12 June, 2009), the study was switched to~     single-arm, open-label treatment, and all patients remaining in the placebo arm were switched~     to open-label ambrisentan treatment. Patients who enrolled after Amendment 2 all received~     open-label ambrisentan.~   "
224697|NCT00617292|"~     Congenital adrenal hyperplasia (CAH) is a genetic disorder that affects the amount of~     steroids that the body forms. The most common form of CAH is 21-hydroxylase deficiency~     (21OHD), which leads to cortisol deficiency and causes the development of mature masculine~     characteristics in newborn, prepubescent, and grown females, and prepubescent males. Prenatal~     treatment with dexamethasone, a corticosteroid, has been shown to reduce the masculinization~     of genitalia. However, the long-term effects of dexamethasone on the children who received it~     as fetuses and on mothers who were exposed to it while they were pregnant have not been~     determined. This study will investigate potential long-term adverse side effects of prenatal~     dexamethasone treatment in children and young adults who received dexamethasone as fetuses~     and their mothers who were exposed to it during pregnancy.~   "
224698|NCT00617279|"~     The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than~     disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12~     months.~   "
224699|NCT00617266|"~     The Business Process Outsourcing BPO industry has been rapidly expanding in India over the~     last 10 years. There is a concern regarding issues of health and safety that are unique to~     this new and developing industry. The lack of reliable and relevant information on which to~     base the response to this concern poses a challenge for safeguarding the health of BPO~     employees. Elevated stress levels, shift duties, high work targets, lofty income may force~     many towards addictions to keep them going.~      Use of tobacco, which is very common addiction in India, is associated with several health~     hazards. Anecdotal evidence suggests that smoking and other forms of addictions are at its~     peak in the BPO industries. We are conducting a research on the tobacco habits among Business~     Process Outsourcing (BPO) employees to understand the prevalence of different forms of~     tobacco addiction and the reasons for initiation and continuation of the habit. We will also~     offer different interventions as a measure of tobacco cessation.~   "
224700|NCT00617253|"~     This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose~     escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in~     combination with sunitinib.~      The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing~     the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.~   "
224701|NCT00617240|"~     The purpose of this pilot study is to determine whether starting metformin in conjunction~     with a second-generation antipsychotic (SGA) and providing information about healthy eating~     and activity will prevent or reduce the amount of weight gain and the metabolic changes in~     adolescent youth typically seen with second-generation antipsychotic medication.~   "
224702|NCT00617227|"~     The study is based on the hypothesis that decreased creatinine clearance may be associated~     with detectable vancomycin levels in patients on enteral (oral / vancomycin enemas)~     vancomyicn for CDAD.~      The objective of the study is to see whether enteral vancomycin is absorbed through the~     inflamed GI mucosa in CDAD, and if it is absorbed, does it achieve measurable serum~     concentration.~   "
224703|NCT00617214|"~     Purpose of this non-interventional study (NIS) is to assess the effect of the participation~     in an integrated care program on treatment outcomes in patients treated with Seroquel for~     schizophrenia.~   "
224704|NCT00617201|"~     This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate~     atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent~     individuals, who are healthy and are seeking treatment for their substance abuse, will be~     randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial~     lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve~     maintenance on the assigned active dose safely. Contingency management procedures will be~     used to reinforce attendance and compliance with study procedures. Primary outcome measures~     will include urinalysis data assessing cocaine use.~   "
224705|NCT00617188|"~     RATIONALE: Estrogen can cause the growth of ovarian epithelial cancer cells. Hormone therapy~     using fulvestrant may fight ovarian cancer by blocking the use of estrogen by the tumor~     cells.~      PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with~     recurrent ovarian epithelial cancer.~   "
224707|NCT00617149|"~     Background:~      Use of variable definitions of exercise and disparate results, emphasize the need of proper~     randomized controlled trials examining the relationship between physical activity and weight~     development during pregnancy. So far, only few intervention studies aiming at weight~     management during pregnancy have been performed (Gray-Donald et al., 2000,Olson et al.,~     2004,Polley et al., 2002,Kinnunen et al., 2007). Moreover, most of these interventions have~     focused on how gestational weight gain may be altered through individual counselling~     combining diet and exercise habits, rather than supervised training. Search on PubMed~     revealed no randomized controlled trial where the main outcome was to investigate how the~     effect of supervised structured exercise may reduce the proportion of women gaining more~     weight than optimal. The aim of the present study is to assess whether a 12-week aerobic~     exercise program during pregnancy can prevent excessive gestational weight gain.~      Method:~      This is a single blind randomized controlled trial to evaluate the effects of a structured,~     supervised aerobic exercise program on weight gain stabilization in primiparous pregnant~     women. The aim is to include 100 women. Interested women eligible for the present study will~     be invited to a pre-test including interview and assessments at the university. The women are~     examined three times during the study period. The first visit is between 12 and 24 weeks of~     gestation, the second at week 36-38 and the last 8-12 week after delivery. The exercise~     program consists of supervised exercise for 60 minutes, performed at least 2 times per week,~     for 12-16 weeks. Compliance with the training protocol is controlled by the instructors and~     registrations in the womens personal training diary~   "
224708|NCT00617136|"~     The investigators aim to investigate the effects of prewarming of patients undergoing~     elective orthopedic surgery on intraoperative temperature control and blood loss and~     postoperative patient discomfort and glucose and insulin levels.~   "
224709|NCT00617123|"~     This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in~     participants with established atherosclerotic disease who are enrolled into the TRA 2°P -~     TIMI 50 Study (P04737) (NCT00526474).~   "
224710|NCT00617110|"~     Allergic rhinitis (AR) is a condition that exists when an individual with a specific allergy~     reacts to that allergen resulting in a runny and/or stuffy nose, postnasal drip, and possible~     symptoms of sneezing, scratchy throat, itchy nose, ears or throat. When the allergic person~     is exposed to such an allergen, the body reacts with overproduction of certain chemicals~     which cause inflammation and subsequent symptoms of AR. These responses are related to the~     body's hyperreactive response to exposure to an otherwise harmless substance such as dust,~     ragweed, pollen, cat dander etc.~      There are data to suggest that air pollution resulting from diesel exhaust can increase the~     body's response to airway inflammation caused by virus.~      The purpose of this research study is to determine if individuals with AR have increased~     inflammatory responses to flu virus following exposure to diesel exhaust (DE) vs exposure to~     clean air compared to how individuals who do not have allergies respond to the same exposure~     conditions. The hypothesis for this study is that diesel exhaust exacerbates LAIV-induced~     allergic nasal inflammation, using controlled exposures in AR volunteers compared to~     non-allergic individuals~   "
224711|NCT00617097|"~     The investigators primary objective is to study the analgesic effects of combined ketorolac~     and lidocaine in a paracervical block compared to preoperative ibuprofen followed by~     intra-operative paracervical block with lidocaine alone on women undergoing first trimester~     surgical abortions. The investigators hypothesize that women who receive a paracervical block~     of combined ketorolac and lidocaine will experience less pain during the procedure based on a~     visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a~     paracervical block with lidocaine alone.~      This randomized, multi-site, placebo-controlled clinical trial will investigate the~     difference in perceived pain from first trimester surgical abortions using a paracervical~     block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical~     block with lidocaine alone. A total of fifty women who are seeking elective surgical~     abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited~     from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore,~     Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during,~     and after surgical abortion will be measured using a 100-mm VAS.~      The primary outcome of interest is the mean difference in pain level from preoperative~     baseline to time after cervical dilation comparing the treatment groups. If the investigators~     see greater pain reduction associated with the paracervical block of lidocaine and ketorolac,~     adoption of this regimen may improve pain management during first trimester surgical~     abortions. If combined ketorolac and lidocaine when administered as a paracervical block is~     proven to be efficacious, the need for additional analgesia in first trimester surgical~     abortions can be minimized.~   "
224712|NCT00617084|"~     The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm,~     international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The~     study is a real world, all comers study.~      Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent)~     system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac~     death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion~     Revascularization at 1 year in a real world patient population.~   "
224713|NCT00617071|"~     RATIONALE: Developing a personalized screening plan may be more effective than usual care in~     increasing the number of healthy participants who regularly undergo screening for colorectal~     cancer.~      PURPOSE: This randomized phase III trial is studying personalized screening plans to see how~     well they work compared with usual care in increasing colorectal cancer screening in healthy~     participants.~   "
224714|NCT00617058|"~     The purpose of this study is to evaluate the relative risks and benefits of two approaches to~     the control of weight gain and other negative side effects in children and adolescents on 2nd~     generation antipsychotics (SGA):~        -  Healthy lifestyle instruction (nutritional and physical activity surveillance and~          advice) + continuation of current SGA;~        -  Add the diabetes drug, metformin + continuation of current SGA.~   "
224715|NCT00617045|"~     The purpose of this study is to assess whether the antidepressant, duloxetine, is equally~     effective as a treatment for subjects who have a Postpartum Onset Depression compared to~     subjects who have an onset of Major Depressive Disorder prior to delivery. The hypothesis is~     that duloxetine will be as effective in subjects with Postpartum Major Depressive Disorder as~     in subjects with a Major Depressive Disorder.~   "
224716|NCT00617032|"~     Study 1304 is a Phase I dose escalation study conducted in adults with persistent moderate~     (grade 2) or severe (grade 3) swelling due to inflammatory arthritis (rheumatoid arthritis,~     psoriatic arthritis, or ankylosing spondylitis) in at least one peripheral joint eligible for~     injection. Disease must not be severe enough to warrant use of a TNF-alpha antagonist in the~     next three months.~      Current use of TNF-alpha antagonists is not permitted. Subjects with rheumatoid arthritis~     must have had an adequate trial of at least one disease-modifying antirheumatic drug (DMARD)~     prior to screening.~      The primary objective is to evaluate the safety of intra-articular administration of tgAAC94.~   "
224717|NCT00617019|"~     The purpose is to explore the frequency of impulse control disorders in Parkinson's patients~     treated with different Parkinson's medications.~   "
224718|NCT00617006|"~     We hypothesized that by improving hand hygiene compliance in the operative environment, we~     would reduce horizontal transmission of pathogenic bacteria to surgical patients.~   "
224719|NCT00616993|"~     The purpose of this phase III study is to determine the safety and efficacy of difluprednate~     in the treatment of inflammation following ocular surgery.~   "
224720|NCT00616980|"~     The purpose of this study is to evaluate the safety and efficacy of intramuscular injections~     of adult stem cells in patients with Critical Limb Ischemia (CLI).~   "
224721|NCT00616967|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized~     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help~     carboplatin and paclitaxel albumin-stabilized nanoparticle formulation work better by making~     tumor cells more sensitive to the drugs. Giving chemotherapy with or without vorinostat~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed.~      PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with~     paclitaxel albumin-stabilized nanoparticle formulation works with or without vorinostat in~     treating women with breast cancer that can be removed by surgery.~   "
224722|NCT00616954|"~     This study is planned to evaluated whether ATG is needed in haploidentical stem cell~     transplantation~   "
224723|NCT00616941|"~     This is an open label, Phase I study of vaccination with NY-ESO-1 OLP4 with or without~     immunoadjuvant Montanide and Poly-ICLC in patients with epithelial ovarian, fallopian tube,~     or primary peritoneal cancer in second or third clinical remission.~      The primary and secondary endpoints of the study are to determine the safety and~     immunogenicity of NY-ESO-1 OLP4 vaccination with or without immunoadjuvants Montanide and~     Poly-ICLC.~   "
224724|NCT00616928|"~     The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to~     characterize the immunogenicity & safety of the investigation vaccination regimen of GSK~     1557484A vaccine given to adults aged ≥18 years.~   "
224725|NCT00616915|"~     Wellbutrin (bupropion) is an effective antidepressant (Thase, M 2005). It exists in instant~     release (IR), sustained release (SR) and extended release (XL) forms. The IR formulation was~     never approved for use in Canada. The XL formulation allows for once daily dosing.~      Wellbutrin is both a norepinephrine and dopamine reuptake inhibitor, and as such increases~     the synaptic concentration of both neurotransmitters. This adds to its positive effects on~     cognition, apathy, tiredness and executive functioning. The increased activation may be also~     responsible for some of its side effects such as initial insomnia and reduced sleep~     efficiency, especially when taken at night.~   "
224726|NCT00616902|"~     To evaluate the effects of paricalcitol injection on cardiac structure and function over 48~     weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have~     left ventricular hypertrophy (LVH).~   "
224727|NCT00616889|"~     Clinical practice indicates that Quetiapine has sedating properties, and its sedative effects~     may play an important role in restoring quality of sleep in patients with various psychiatric~     conditions who frequently experience sleep disturbances as part of their illness. It is well~     known that depressive disorders are very frequently associated with significant sleep~     disturbance. Sleep disruption is a feature of Bipolar Disorder during both Depressed and~     Manic/Hypomanic episodes. Considering that Seroquel has good antidepressant properties~     (Calabrese, 2004), the investigators suggest that Seroquel's effect on sleep architecture~     contributes to its antidepressant properties.~   "
224728|NCT00616876|"~     A pilot study to test the safety of use of lactulose in preterm infants and to preliminary~     assess the hypothesis that lactulose would support the early growth of Lactobacilli in the~     stools of premature infants and possibly would also improve nutritional status and decrease~     NEC and late-onset sepsis.~   "
224729|NCT00616863|"~     The objective of this study was to assess the bioequivalence of a potential generic 600 mg~     oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet,~     Trileptal, folloiwng a single 600 mg dose administered with food.~   "
224730|NCT00616850|"~     Total knee replacement is often associated with severe postoperative pain, especially in the~     first 24 hours. Patient controlled analgesia (PCA) and continuous femoral block with PCA are~     commonly used to treat postoperative pain after total knee arthroplasty. However, PCAs use~     opioids. Opioids are excellent painkillers but their use is hampered by side effects such as~     nausea, vomiting, bowel dysfunction, urinary retention, pruritus, sedation and respiratory~     depression. We propose to test the hypothesis that adding a low dose lidocaine infusion to~     PCAs will lower the amount of opioids that these patients receive, thereby improving patient~     safety while still providing adequate analgesia. In addition, continuous femoral block has~     been shown to provide superior postoperative pain control when compared to morphine PCA.~     Therefore, postoperative pain levels of study subjects will be compared to those subjects who~     receive a combination of a continuous femoral block catheter with a PCA.~   "
224783|NCT00616135|"~     A post-marketing study evaluating the transplantation of autologous fat augmented with~     Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast~     deformities post segmental mastectomy or quadrantectomy (lumpectomy).~   "
224954|NCT00613795|"~     This study utilizes lactobacillus, or probiotics, delivered twice daily to the mouth and~     stomach, via feeding tube, in effort to determine whether the oral administration of a~     naturally occurring Lactobacillus species reduces the incidence of ventilator associated~     pneumonia therefore reducing intensive care unit(ICU)complications.~   "
224731|NCT00616837|"~     Patients from 4 local communities in northern Norway referred (either new or follow up) to~     orthopaedic department, University hospital of Northern Norway for outpatient consultation,~     are randomly assigned to either remote consultation by use of telemedicine (camera and~     screen), or standard consultation at the hospital. There are x-ray facilities also at the~     remote site. The patients randomized to telemedicine consultation meet special trained nurses~     at the remote site, but doctor only by video conference. The patients will be followed for up~     to one year. The primary endpoint is quality of care achieved with the telemedicine~     consultation as compared to standard outpatient consultation (assessed by questionnaires~     filled out by the doctor involved). Secondary end points are patient satisfaction assessed by~     questionnaires and economic analyses. The study hypothesis is non-inferiority of telemedicine~     consultation vs. conventional, outpatient consultation.~   "
224732|NCT00616824|"~     This study intends to compare postoperative outcomes of a tissue expander placement following~     a mastectomy with two different operative techniques. This study will be randomized and~     double blinded comparing the traditional placement of the tissue expander under an~     inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix~     as an inferolateral sling, instead of the muscle flap.~      The study we are proposing will evaluate the question of whether there is a difference~     between the traditional method of serratus flap and the new technique of using an acellular~     matrix with tissue expander placement. This will be a double blinded randomized study of~     thirty women in each group comparing outcomes which will include postoperative pain,~     complications (wound infection, hematoma, capsular contracture, etc), and patient~     satisfaction with the procedure.~   "
224733|NCT00616811|"~     This clinical trial is designed to provide additional information on the safety and~     tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in~     patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular~     filtration rate (GFR) < 30 mL/min) for a period of 24 weeks.~   "
224734|NCT00616798|"~     This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia~     who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone,~     paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms.~     After a 4 week run in period on their current anti psychotic treatment, patients will be~     randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on~     therapy. The anticipated time o n study treatment is <3 months, and the target sample size is~     100-500 individual s.~   "
224735|NCT00616785|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving~     combination chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with radiation therapy works in treating patients with stage III non-small cell lung cancer~     that cannot be removed by surgery.~   "
224736|NCT00616772|"~     The primary purpose of this study is to test the effect and safety of once daily ABT-335 on~     the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients~     with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol~     (bad cholesterol) after taking atorvastatin.~   "
224737|NCT00616759|"~     Participating subjects are those who are referred for electroconvulsive therapy (ECT) for~     severe depression who have agreed to the protocol. The control group receives ECT as usual.~     The other group receives propofol to terminate the ECT-induced seizure timed so that the~     seizure lasts at least 25 seconds. Extensive neuropsychological testing is being done on both~     groups before beginning ECT and within 48 hours after the 6th treatment. Multiple markers of~     the rapidity of recovery from anesthesia are being obtained from all subjects for 6 ECTs.~   "
224738|NCT00616746|"~     The purpose of this study is to characterize the interactive effects of acute intravenous~     (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use~     alcohol.~   "
224739|NCT00616733|"~     This is a 12-week study to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.~   "
224740|NCT00616720|"~     RATIONALE: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the~     immune system in different ways and stop cancer cells from growing. Vaccines made from a~     person's white blood cells may help the body build an effective immune response to kill~     cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer~     cells.~      PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon~     gamma together with vaccine therapy works in treating patients with multiple myeloma.~   "
224741|NCT00616707|"~     The purpose of this study is to determine if there are signs of inflammation in one's blood~     and urine and to find out if one's body size or ethnicity has an effect on these substances.~   "
224742|NCT00616694|"~     To evaluate the effect of subject knowledge of their disease status on persistence in~     subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment~     of GIO.~   "
224743|NCT00616681|"~     The objective of this study was to assess the bioequivalence of a potential generic 600 mg~     oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine~     tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.~   "
224744|NCT00616668|"~     The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to~     Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and~     the process of rehabilitation.~   "
224745|NCT00616655|"~     To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized~     anxiety disorder (GAD).~   "
224746|NCT00616642|"~     RATIONALE: Rosiglitazone may help pituitary adenoma cells become more like normal cells, and~     grow and spread more slowly.~      PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients~     with newly diagnosed or residual or recurrent pituitary adenoma.~   "
224747|NCT00616629|"~     The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological~     properties and intracardiac pressures~   "
224748|NCT00616616|"~     Laparoscopic surgery being performed with only one small incision via the umbilicus (belly~     button).~   "
224749|NCT00616603|"~     Dexamethasone is a commonly used steroid. This medication has been used for many years by~     physicians for many different indications. Recent articles, multiple case reports, and~     experience at this institution have indicated that dexamethasone successfully prolongs the~     effective duration of local anesthetics for regional blocks. This can cause a significant~     reduction in postoperative pain and the decreased need for postoperative narcotics. Although~     other adjuncts can be used for prolonging nerve blocks, epinephrine causes local~     vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the~     sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of~     a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the~     effectiveness of dexamethasone, both locally through the nerve block and systemically via IV~     administration, in prolonging the effective duration of local anesthetics when used in~     sciatic nerve blocks.~   "
224750|NCT00616590|"~     RATIONALE: Learning about insomnia and quality of life in patients undergoing chemotherapy~     and radiation therapy for cancer may help doctors learn about the effects of treatment and~     plan the best treatment.~      PURPOSE: This clinical trial is studying insomnia in patients undergoing chemotherapy and~     radiation therapy for head and neck cancer.~   "
224751|NCT00616577|"~     Caudal epidural analgesia (caudal block) is used in standard pediatric anesthesia practice.~     It has been shown to be effective in managing postoperative pain in children undergoing~     abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown~     that children receiving caudal blocks have secondary benefits such as lower narcotic and~     anesthetic requirements, more rapid awakening from general anesthesia, decreased time to~     discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias~     et al 1995, Tobias 1996).~      This proposed study involves the use of a caudal block in children undergoing elective~     inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in~     pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a~     caudal block before the onset of a painful stimulus, we can decrease central nervous system~     sensitization and reduce postoperative analgesic requirements.~   "
224752|NCT00616564|"~     High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998.~     Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol~     will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions~     discussed above.~   "
224753|NCT00616551|"~     The purpose of this study is to assess the biological safety and efficacy of using the drug,~     C2L-OCT-01 PR, 30 mg to treat acromegalic patients.~   "
224754|NCT00616538|"~     Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed.~     EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does~     not contain corticosteroids or other anti-inflammatory drugs. The objective of the present~     study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to~     severe atopic dermatitis as compared to mid-strength topical steroid cream following twice~     daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients~     lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as~     shown in previous studies and eliminate or reduce the requirement for supplemental topical~     steroid administration.~   "
224755|NCT00616512|"~     The Purpose of the GF Strong water protocol is to allow clients who have thin liquid~     dysphagia to drink water under certain specified conditions according to the rules of the~     water protocol. Water Protocols have been shown to improve client satisfaction, and~     hydration. We wish to assess this in a randomized, controlled fashion, and this is a pilot~     project to determine feasibility.~   "
224756|NCT00616499|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with~     stage IIIA non-small cell lung cancer.~   "
224757|NCT00616486|"~     Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in~     addition to the standard treatment regimen for OCD, will lead to significant improvement in~     patients' symptoms. The clinical improvement detected by YBOCS, CGI and SF-36 QOLS scores~     will be statistically significant in active treatment group compared to sham (placebo)~     treatment group.~   "
224758|NCT00616473|"~     The purpose of this study is to examine key organizational structures and processes~     (leadership, teamwork, communication, palliative care) and their impact on the quality of~     end-of-life care for dying residents and their family members.~   "
224759|NCT00616460|"~     To determine the safety/efficacy of Bivallirudin Vs unfractionated heparin (UFH) on top of~     dual antiplatelet therapy in patients with high tendency for bleeding during urgent and~     elective PCI.~   "
224760|NCT00616447|"~     This study will compare the change detected by a standardized rating scale (Hamilton Anxiety~     Rating Scale) scores in the active treatment group as compared to sham (placebo) group after~     6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to~     improvement of core symptoms in patients with GAD.~   "
224761|NCT00616434|"~     The primary objective of the study is to evaluate the clinical activity of interferon beta-1a~     in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this~     study are to determine (i) the safety and tolerability of interferon beta-1a in participants~     with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the~     Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.~   "
224762|NCT00616421|"~     To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given~     to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein~     conjugate vaccine.~   "
224784|NCT00616122|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and~     methotrexate, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving sunitinib together with combination~     chemotherapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib when~     given together with cyclophosphamide and methotrexate to see how well they work in treating~     patients with metastatic breast cancer.~   "
224763|NCT00616408|"~     In the last two decades, somatostatin analogs have become a cornerstone of medical therapy~     for acromegaly. One year of treatment with octreotide-LAR (LAR) controls GH and IGF-I excess~     in 54% and 63% of unselected patients, with an increasing proportion of subjects achieving~     IGF-I normalization prolonging the treatment. Clinically significant tumor shrinkage (20-30%~     vs. baseline) has also been reported, with a higher proportion in patients treated first-line~     [231 of 448 patients (52%)] than in those treated after surgery and/or radiotherapy [52 of~     248 patients (21%)]. The highest rate of clinically significant shrinkage (>20%) occurred in~     patients treated first-line with LAR (80%) as compared to the short-lasting octreotide~     formulation (50%) or lanreotide slow-release formulation (35%. In 99 de novo patients with~     acromegaly, we recently reported control of GH levels in 57.6%, of IGF-I levels in 45.5% and~     a greater than 50% tumor shrinkage in 44.4% after 12 months of first-line treatment with~     somatostatin analogues, either LAR or lanreotide. Besides the different drug used, the~     duration of treatment also plays an important role on the shrinkage magnitude. In a~     homogeneous cohort of 56 patients treated with LAR only and continuously for 24 months, we~     noted an even more sustained effect on tumor shrinkage: overall, tumor volume decreased by~     68.1±16.5% using dosages up-titrated to 40 mg every 28 days.~      Despite this evidence, there is still a debate on the use of first-line treatment with~     somatostatin analogues. Of paramount importance would be the possibility to predict the~     results of one year treatment early after treatment beginning. Controversy has been reported~     on the predictive value of initial tumor size, inhibition of GH and IGF-I levels during~     treatment, and dose or type of the somatostatin analogue used during treatment. We found that~     percent suppression of IGF-I after 12 months of LAR treatment was the parameter that best~     predicted the amount of tumor shrinkage after the same period, but did not investigate the~     results of short-term treatment in the same series.~      This observational, analytical, open, retrospective study was designed to evaluate the~     predictive value of tumor shrinkage, GH and IGF-I suppression after 3 months of~     Octreotide-LAR (LAR) on tumor shrinkage obtained after 12 months. As secondary parameters we~     also studied baseline patients profile such as age of diagnosis, gender, estimated disease~     duration, GH and IGF-I levels and tumor size.~   "
224764|NCT00616395|"~     The purpose of this study is to characterize physical growth, body composition, dietary~     intake, neurobehavioral development, and brain function of infants and children fed mostly~     breast-milk, milk-based formula or soy-based formula during their first year of life.~     Children are followed from age 2 months to age 6 years.~   "
224765|NCT00616382|"~     Persistent postnatal ductal patency may have significant adverse hemodynamic effects,~     frequently necessitating therapeutic intervention in order to facilitate ductal closure.~     Medical therapy for patency of the ductus arteriosus is successful mediating ductal closure~     in approximately 70% of treated infants. In a recent study in our population, 17% of the~     babies showed no ductal response to the first course of treatment and 9.4% of our study~     infants eventually underwent surgical ligation of the ductus after failure of medical~     therapeutic closure.We propose to evaluate and compare two alternate therapeutic approaches~     to ductal closure in babies who do not respond to initial therapy.~   "
224766|NCT00616369|"~     This study is designed to investigate whether an association exists between certain~     genes/protein levels and the development of various cardiopulmonary diseases. It is hoped~     that this project will provide valuable insight into the understanding of these diseases.~   "
224767|NCT00616356|"~     The investigators at Rockefeller University are doing this research to study how the immune~     system responds to viruses and other infectious agents by using the yellow fever 17D vaccine~     as a model. The YFV-17D vaccine is one of the safest and most effective vaccines known and~     has been used to vaccinate humans against yellow fever virus (YFV) infection since the 1930s.~     By studying how the human immune system responds to the YFV vaccine we hope to learn more~     about the normal functioning of the immune system so that it might be possible to design new,~     more effective types of vaccines to prevent important infectious diseases.~      The reason for doing this research is:~      Currently there is very little information about which factors determine the effectiveness of~     the initial (primary) immune response to a foreign substance (antigen), such as a virus, that~     person may be exposed to. There is also very little known about what determines how~     effectively and for how long a person's immune system can react to the same antigen to~     prevent another infection. Studies in animals have given us important information about how~     the immune systems of other animals behave upon initial or repeated exposure to antigens,but~     these topics have not been studied in detail in humans.~      The following hypotheses will be tested:~        -  The magnitude of the initial expansion of T lymphocytes (the clonal burst) specific~          for the infecting virus determines the level at which memory T cell responses are~          generated against the specific viral antigen and the duration of the memory T cell~          response generated in the body.~        -  The majority of CD8 T cells generated after immunization are yellow fever specific and~          not bystander activation of non-specific cells.~   "
224768|NCT00616343|"~     The purpose of this study is to determine if Zonisamide is effective in reducing tremors in~     patients with Essential Tremor.~   "
224769|NCT00616330|"~     This study will evaluate the efficacy and safety of a vaginal product compared with that of~     other vaginal products in the treatment of vaginal infections.~   "
224770|NCT00616317|"~     The purpose of this study is to gather information about causes and treatment of~     Antiphospholipid Syndrome.~   "
224771|NCT00616304|"~     Background: Mortality from severe malaria remains ~15% despite the use of the most rapidly~     parasiticidal antimalarial therapy, artesunate. Adjunctive treatments may improve outcome.~     Our overall goal is to determine if adjunctive treatment with L-arginine is safe and improves~     outcomes in severe malaria. In studies to date, we have shown that L-arginine is safe in~     moderately severe malaria, increases nitric oxide production and improves endothelial~     function. We now propose to extend these studies to patients with severe malaria.~      Aims: To determine the safety, preliminary efficacy, pharmacokinetics and pharmacodynamics of~     L-arginine infusion in severe malaria.~      Hypothesis: L-arginine will improve endothelial function, lactate clearance time and tissue~     oxygen delivery compared to saline with no clinically significant adverse effects.~      Methods: Based on previous pharmacokinetic modeling and simulations, we propose a phase 2A~     randomised controlled trial of L-arginine vs saline in severe malaria, each given over 8~     hours. If safety is demonstrated this will be followed by a phase 2B open-label study of~     24-hour infusion of L-arginine in severe malaria with safety and preliminary efficacy~     compared with the 8 hour infusions given in phase 2A.~      The primary outcomes will be the improvement in endothelial function and lactate clearance in~     patients given L-arginine infusion compared with those who received saline. Among the~     secondary outcomes will be safety and the effect of L-arginine vs saline on tissue oxygen~     delivery (NIRS).~      Data from both phase 2A and 2B will be used to generate a pharmacokinetic/ pharmacodynamic~     model.~   "
224772|NCT00616291|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating~     patients with metastatic prostate cancer.~   "
224773|NCT00616278|"~     The purpose of this study is to learn whether growth hormone being administered to children~     with Chronic Kidney Disease is effective and if it has any side effects.~   "
224774|NCT00616265|"~     The working hypothesis for the present study is that treatment with CPAP in patients with an~     sleep apnea (IAH>15) and AHT-r is capable of producing significant reductions in~     blood-pressure levels.~      This hypothesis is supported by four proven findings:~        1. -sleep apnea is an independent risk factor for arterial hypertension (1).~        2. -The greater the number of RSD, the greater the loss of control over blood-pressure~          levels (1).~        3. -The prevalence of sleep apnea in patients with AHT refractory to treatment is very high~          (11,12).~        4. -Treatment of patients with sleep apnea and AHT-r with CPAP succeeds in significantly~          reducing blood-pressure levels in the only (small-scale) studies undertaken to date~          (14,15).~      4. OBJECTIVES~      Main objective:~      To evaluate the effect of treatment with CPAP on blood-pressure levels in patients with AHT~     refractory to medical treatment.~      Secondary objectives:~        -  To evaluate the effect of treatment with CPAP on the various elements assessed in BP~          (systolic/diastolic; daytime/nighttime, etc) and the circadian profile~          (dipper/non-dipper/raiser patterns; variability and homogeneity of blood-pressure~          levels, etc) obtained during a 24-hour out-patient study (AMPA).~        -  To analyze the related variables or subgroups of patients most affected by treatment~          with CPAP.~        -  To evaluate the effect of CPAP on the levels of some of the biological variables~          involved in the pathogenesis of AHT-r (renin, angiotensin, aldosterone, atrial~          natriuretic factor, etc).~   "
224775|NCT00616252|"~     In HIV-infected women, the use of combination therapy with antiretrovirals (ARV) in pregnancy~     prevents HIV related morbidity and mortality and prevents mother-to-child transmission of the~     HIV virus.~      Specifically, suppression of the virus to an undetectable level is important during the~     delivery of the baby to minimize potential HIV exposure. In Sub-Saharan Africa, the use of~     ARV combinations containing nevirapine is the cornerstone of current HIV therapy, due to an~     affordable cost, availability in a fixed dose combination pill, and generic availability.~     Maintaining the efficacy and preventing development of resistance against this agent by the~     HIV virus is imperative, as second line therapies are often more difficult to obtain, are~     more expensive, and present more challenges in drug storage in clinics and in the community.~      Pregnancy adds another dimension to the challenge of treating women with HIV, as the~     physiologic and metabolic changes can affect levels of antiretroviral agents in the body.~     Though these changes are known to exist, few trials have evaluated the effect of these~     factors on the pharmacokinetics of antiretroviral agents and their impact has yet to be~     demonstrated.~      We wish to evaluate if the physiologic changes that occur during pregnancy impact the levels~     of stavudine, lamivudine, and nevirapine compared to those of a non-pregnant, HIV-infected~     Ugandan female. These data are imperative to ensure adequate suppression of the HIV virus~     throughout pregnancy.~   "
224776|NCT00616239|"~     This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream~     twice daily to affected areas on the face for 14 weeks and half the face will be peeled with~     20-30% salicylic acid every two weeks for a total of 4 peels. The first two peels will be 20%~     salicylic acid and the second two peels will be with 30% salicylic acid. The purpose of the~     study will be to evaluate the safety and efficacy of salicylic acid combined with 4%~     hydroquinone versus 4% hydroquinone alone.~   "
224777|NCT00616213|"~     RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in~     bone marrow or peripheral blood and may help the immune system recover from the side effects~     of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given~     together with G-CSF in treating patients with solid tumors.~   "
224778|NCT00616200|"~     The purposes of this study are to prospectively determine the effect of a very low~     carbohydrate diet on quality of life and gastrointestinal symptoms in patients with~     diarrhea-predominant irritable bowel syndrome (IBS-D); and to determine possible~     physiological correlates of symptom improvement, as related to post-prandial~     5-hydroxytryptamine (5-HT) release, weight loss and fiber content.~   "
224779|NCT00616187|"~     A phase II open-label baseline-to-treatment trial was designed to evaluate the safety,~     tolerability and efficacy of orally administered atorvastatin in patients with~     relapsing-remitting multiple sclerosis (RRMS). Patients with at least one~     gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were~     eligible for the study. Patients are screened and enrolled in the outpatient clinic of the~     Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3~     monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg~     atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9~     compared to baseline. Secondary endpoints include other MRI-based parameters and changes in~     clinical scores and immune responses.~   "
224780|NCT00616174|"~     The purpose of this study to investigate whether using a special warming blanket during~     Cesarean delivery helps maintain a normal body temperature in the baby when compared to~     mothers that are not warmed (standard care at BC Women's Hospital). Doctors observed that~     some babies have low body temperatures when they are born by Cesarean delivery. Since baby~     temperatures are dependant on the temperatures of their mothers, we believe that keeping the~     mother warm during surgery with the use of a special warming blanket that is filled with warm~     air will result in the baby being warmer at birth.~   "
224781|NCT00616161|"~     The purpose of this study is to determine the minimum effective dose of Istaroxime, in~     patients requiring hospitalization for deterioration of chronic heart failure and left~     ventricular systolic dysfunction. This goal will be reached by comparing the hemodynamic~     effect of three different doses of the drug versus placebo. Efficacy will be measured as a~     change in Pulmonary Capillary Wedge Pressure from pre-infusion to the last assessment at six~     hours intravenous infusion.Secondary objectives will be to evaluate safety, tolerability and~     efficacy on other main hemodynamic parameters, echocardiographic and echo-doppler~     measurements, plus preliminary pharmacokinetics of the drug.~   "
224782|NCT00616148|"~     The aim of this study is to evaluate the ability of a single oral dose of YKP3089 to abolish~     or clearly reduce the IPS-induced photo-paroxysmal EEG response in photosensitive epilepsy~     patients, and to measure the onset and duration of the effect. Several cohorts will be used,~     to sequentially investigate different doses.~   "
224785|NCT00616109|"~     The goal of this study is to determine the progression-free survival rate in patients with~     extensive-stage small cell lung cancer who had achieved complete response, partial response,~     or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or~     carboplatin in combination with etoposide or irinotecan. In addition, the safety and~     effectiveness of sunitinib will also be evaluated.~   "
224786|NCT00616096|"~     The purpose of this study is to determine whether immunoadsorption is effective in the~     treatment of severe atopic dermatitis associated with excessively high serum IgE levels.~   "
224787|NCT00616083|"~     The purpose of this study is to learn about normal body composition (% body fat) during the~     first six months of life in healthy breast-fed babies.~   "
224788|NCT00616070|"~     The purpose of this phase III study is to determine the safety and efficacy of difluprednate~     in the management of inflammation following ocular surgery.~   "
224789|NCT00616057|"~     Obesity is constantly increasing, causing an important risk to develop diseases such as heart~     disease, diabetes,... Some recent studies have shown that obese people present modifications~     of colon microflora and a low-grade inflammation.~      In our laboratory, we have demonstrated that the intake of fructans lessens dietary intake,~     body weight gain, adipose tissue accumulation and steatosis in rodents. These effects lead to~     an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. Fructans~     are also able to restore the microflora disturbed by a high fat diet and to prevent~     endotoxemia. Moreover, studies have shown that fructans intake promotes satiety (Cani et al,~     Diabetes 2007) and or decreases fat mass (Abrams et al, Journal of Pediatrics 2007) in~     healthy human. An intervention study in obese patients is thus needed to study the effects of~     fructans in the target population.~   "
224790|NCT00616044|"~     In major orthopaedic surgery of the lower extremities both continuous spinal anesthesia (CSA)~     and combined spinal epidural anesthesia (CSE) are safe and reliable anaesthesia methods. Our~     results suggest that both continuous spinal anesthesia and combined spinal epidural~     anesthesia provide good surgical conditions with a low incidence of complications. The~     sensory block level and hemodynamic changes were lesser with CSA.~   "
224791|NCT00616031|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Nitroglycerin may help carboplatin and paclitaxel work better by making tumor cells~     more sensitive to the drugs.~      PURPOSE: This phase II randomized trial is studying how well giving nitroglycerin together~     with paclitaxel and carboplatin works and compares it to giving paclitaxel and carboplatin~     alone in treating patients with previously untreated stage III or stage IV non-small cell~     lung cancer.~   "
224792|NCT00616018|"~     Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by~     processing it in the liver. During the processing, some of the acetaminophen may bind to~     proteins in the liver. The protein-acetaminophen product is called an adduct. After a large~     acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of~     adducts are formed. However, we have found that lower levels may be formed even when people~     take recommended doses. The purpose of this study is to measure the amount of adducts formed~     when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.~   "
224793|NCT00616005|"~     Objective:~      To determine activity of combo of Irinotecan + Temozolomide To further characterize any~     toxicity associated w combo of Irinotecan + Temozolomide~   "
224794|NCT00615992|"~     The primary goal of this post marketing surveillance (PMS) study is to document the efficacy~     of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended~     in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course~     of the disease.~   "
224795|NCT00615979|"~     The goal of this study is to improve survival of battlefield trauma through ultrasound~     telemedicine and remotely guided therapeutics.~   "
224796|NCT00615966|"~     The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney~     transplant recipients.~   "
224797|NCT00615940|"~     This randomized, double-blind, placebo controlled phase II trial is studying how well~     capecitabine works when given in combination with WX-671 or when given alone in treating~     patients receiving first-line therapy for her2negative metastatic breast cancer.~   "
224798|NCT00615927|"~     Primary objective:~        -  To evaluate activity of imatinib mesylate and hydroxyurea among patients with~          progressive/recurrent grade II low-grade glioma (LGG) as measured by 12-month~          progression free survival~      Secondary objectives:~        -  To evaluate progression-free survival (PFS), overall survival and objective response~          rate among patients with progressive/recurrent grade II LGG treated with imatinib~          mesylate plus hydroxyurea~        -  To assess safety and tolerability of imatinib mesylate + hydroxyurea in this population~   "
224799|NCT00615914|"~     The survey is conducted to collect safety and effectiveness information on the use of~     Pramipexole for long time of period in daily clinical settings in Japan.~   "
224800|NCT00615901|"~     CMF (cyclophosphamide, methotrexate, fluorouracil) is used to treat early stage breast~     cancer. The combination, of these three drugs, has been used for approximately 30 years in~     the treatment of breast cancer, and has been shown to be safe and effective. It is usually~     given every 3 weeks. Doctors believe, based on other breast cancer trials, that giving this~     type of chemotherapy in a shorter amount of time, every 2 weeks or sooner, instead of every 3~     weeks, may be better. The purpose of this study is to test the safety of these drugs, given~     every 2 weeks or sooner, to treat breast cancer. Other breast cancer chemotherapy regimens~     have shown to be more beneficial when the drugs are given more frequently.~   "
224801|NCT00615888|"~     Fast track programs have been introduced in many surgical fields to minimize postoperative~     morbidity and mortality. Morbidity after elective open infrarenal aneurysm repair is as high~     as 30%, mortality ranges up to 10%. In terms of open infrarenal aneurysm repair no randomized~     controlled trials exist to introduce and evaluate such patient care programs.~   "
224802|NCT00615875|"~     The purpose of this study is to determine whether using an additional 48 hours of oral~     naproxen, after other post-operative pain medications have been stopped, will be effective in~     reducing opiate pain medication requirements and contribute to improved pain management.~   "
224803|NCT00615862|"~     Patients with alcohol use disorders are often cared for in the intensive care unit (ICU). We~     estimate that close to half of the patients we care for in our ICU have alcohol use~     disorders. One of the reasons that patients with alcohol use disorders are frequently cared~     for in our ICU is because patients with alcohol use disorders are at higher risk of~     developing infections. The medical term for infections is sepsis. When an infection develops,~     patients with alcohol use disorders tend to get more severely ill compared to patients who do~     not have alcohol use disorders. Patients with alcohol use disorders are also at higher risk~     of dying when they develop severe infections.~      The purpose of this study is to determine why patients with alcohol use disorders become more~     severely ill when they develop infections. There are a number of reasons why this is~     possible. One reason is that a hormone called cortisol is higher in individuals with alcohol~     use disorders (who do not have infections). This hormone is also higher in patients who are~     at increased risk of dying from severe infections. One of the aims of this study is to see if~     cortisol levels are higher in patients with alcohol use disorders compared to those who do~     not have alcohol use disorders.~      Another reason why patients with alcohol use disorders are at increased risk of developing~     infections is because their immune system is not functioning properly. A second aim of this~     study is to see if certain markers of immune function are different in patients with alcohol~     use disorders compared to patients without alcohol use disorders.~      Patients with alcohol use disorders are also more likely to become confused when they are in~     the ICU. This condition is called delirium. Delirium is marked by abrupt onset of altered~     level of consciousness, disorganized thinking, and inattention that changes over time.~     Delirium tremens is one form of delirium. About 80% of our ICU patients develop delirium, and~     many patients who do not have alcohol use disorders develop the disorder as well. Patients~     with alcohol use disorders who have high cortisol levels have a higher chance of developing~     delirium compared to patients with normal cortisol levels. A third aim of this study is to~     examine the relationship between delirium and cortisol in both patients with and without~     alcohol use disorders.~   "
224804|NCT00615849|"~     For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb~     obliteration with pleural adhesive procedure is generally accepted as a standard. But~     additional pleurodesis is potentially useless procedure on the parietal pleura for treating~     visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural~     physiology and cause chronic pain. According to our previous study, stapling resection of the~     bulla without pleurodesis gave comparable result in recurrence comparing with articles with~     additional pleurodesis. The purpose of this study is to evaluate surgical outcome of~     thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure~     is essential in the management of PSP.~   "
224805|NCT00615836|"~     The purpose of this study was to investigate the long term efficacy and safety of several~     doses of the Melt formulation of desmopressin in a broad population of adult patients with~     nocturia.~   "
224806|NCT00615823|"~     Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary~     Hypertension: double-blinded, randomised, prospective phase II study for 6 months with~     adjusted doses of Atorvastatin~   "
224807|NCT00615810|"~     This study aims to investigate whether patients switching their backbone from Kivexa to~     Truvada, who already have raised total cholesterol prior to switching, have an improvement in~     their total cholesterol after 12 weeks of treatment. If an improvement is demonstrated the~     study aims to show whether this has a beneficial effect on the patient's overall~     cardiovascular risk and long term prognosis.~   "
224808|NCT00615797|"~     Children are at risk of developing an involuntary movement disorder after streptococcal~     throat infections. Not all children are affected and the severity is individually variable.~     Affected children have alteration in their behaviour and mood and can become quite~     compromised in their activities of daily living. The condition is believed to be related to~     the body having an over efficient immune response to the infection and some of the antibodies~     made in response to the infection also attack centres in the brain controlling movement and~     mood. Treating these children with immunoglobulins, which mop up the antibodies may reverse~     or improve affected children. This study hopes to clarify this.~   "
224809|NCT00615784|"~     The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class~     drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant~     to standard chemotherapy or are otherwise not eligible for conventional chemotherapy.~     Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects~     within normal and malignant cells that affect cell growth and cell death.~   "
224810|NCT00615771|"~     We are examining whether pregnancy rates differ based on day of embryo transfer in patients~     who replace all available embryos after an In vitro Fertilization (IVF) cycle. Patients must~     be undergoing IVF treatment at Stanford University and patients will not receive compensation~     for their participation (no medical costs covered or patient payment for participation).~   "
224811|NCT00615758|"~     To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with~     locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to~     tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking~     status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated~     with the presence of EGFR mutations in exons 18, 19 and 21, in this population~   "
224812|NCT00615745|"~     A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate~     (tenofovir DF) is the first complete HAART that is offered as one tablet once a day. The~     individual components of this HAART regimen have demonstrated efficacy and safety in HIV~     treatment-naive patients and offer simplification that in turn may increase adherence and~     improve clinical outcomes. This study aims to evaluate the effectiveness (efficacy, safety~     and tolerability) of a STR simplification strategy in patients on HAART who have achieved~     viral suppression in a real world clinical setting.~   "
224813|NCT00615732|"~     The purpose of this study is to assess the effectiveness of qigong for the treatment of~     chronic neck pain compared to exercise therapy and waiting list group.~   "
224814|NCT00615719|"~     The purpose of this study is to evaluate whether 64-slice Computed Tomographic coronary~     angiography is useful for rapid diagnosis or exclusion of significant coronary artery disease~     in patients who present to the Emergency Department with chest pain.~   "
224815|NCT00615706|"~     In the United States there has been a dramatic increase in the number of people who are obese~     and in the number of people who have asthma. Both are considered serious public health~     concerns. Several studies have shown that becoming obese or overweight can increase the risk~     of developing asthma or can make asthma symptoms more severe and difficult to control. How~     obesity affects asthma is not fully understood. This research study will examine whether~     obesity affects the amount of inflammation that is present in the lungs of people with~     asthma, and will also examine whether obesity leads to narrow and stiff airways.~      Participation in this study involves 2 visits in order to complete questionnaires, various~     pulmonary function tests, as well as the collection of blood, urine, and exhaled breath~     condensate specimens.~      This research study includes optional genetic and bronchoscopy substudies.~   "
224816|NCT00615693|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a~     therapy for uveitis. Vision improvement and reduction in the swelling of retina will be~     measured for the assessment of efficacy.~   "
224818|NCT00615654|"~     Objective: To investigate whether patients undergoing aquatic physiotherapy in groups improve~     their functional capacity, by means of the distance covered in the six-minute walk test~     (6WT), and to compare this with a control group. Methods: Forty women that had not been~     practicing regular physical activity for one year were randomly allocated either to the Study~     Group (SG) to undergo an aquatic physiotherapy program in groups applied twice a week,~     including aerobic exercises, muscle strengthening and relaxation for 12 weeks, or to the~     Control Group (CG), which did not do any physical activity. Both groups maintained their~     treatment with medications. All patients underwent two evaluations: one at the start and the~     other after 12 weeks.~   "
224819|NCT00615641|"~     To determine how practical and precise different body composition methods are for measuring~     body fat and lean tissue in young children and to determine if certain dietary factors and~     physical activity patterns are related to body fat in children.~   "
224820|NCT00615628|"~     Researchers have previously demonstrated loss of heterozygosity in a region on chromosome~     18q, associated with osteogenic sarcomas in bone affected by Paget's disease. The loci used~     in this study are specifically described by those authors as showing loss of heterozygosity~     in 6 of 7 affected families.~   "
224821|NCT00615615|"~     Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to~     evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial~     onset seizures.~   "
224822|NCT00615602|"~     This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense~     docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive~     breast cancer overexpressing HER2~   "
224823|NCT00615589|"~     Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem~     cell transplant - a procedure where the patient is treated with high dose chemotherapy and~     then their own (autologous) stem cells are transplanted back into their body. Patients with~     multiple myeloma and high risk genes, always relapse after an autologous transplant and often~     die within two years from the time of their transplant. A different type of transplant~     allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the~     donor cells may help kill the lymphoid cancer cells.~      This study will investigate if a matched donor stem cell transplant using a newer, reduced~     toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple~     Myeloma.~   "
224824|NCT00615576|"~     This is a 4 to 6 week study to look at the safety and PK profile of SB656933 in healthy male~     smokers~   "
224825|NCT00615563|"~     The primary objective of this trial was to assess the presence of susceptibility to~     tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The~     secondary objective was to examine clinicians' use of HIV drug resistance testing in~     treatment experienced patients currently failing a PI based HAART regimen.~   "
224826|NCT00615550|"~     The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel~     in decreasing the preterm birth rate in a population of pregnant women with short cervical~     length and at high risk for preterm birth.~   "
224827|NCT00615537|"~     This proposal is designed as a pilot study for the use of laser ablation for local control of~     symptomatic (e.g compressive) benign thyroid masses in 20 patients.~   "
224828|NCT00615524|"~     This study is being conducted to compare the efficacy and safety of exemestane alone or in~     combination with pazopanib in postmenopausal women who have hormone receptor positive breast~     cancer and have failed therapy with tamoxifen, anastrazole or letrozole.~   "
224829|NCT00615511|"~     Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative~     symptoms and cognitive decline in schizophrenia. After four months the scores on the negative~     symptom scale should be lower and the scores on the cognitive tests should be higher than~     they were at study entry, compared with people who do not take any additional medication.~   "
224830|NCT00615498|"~     Current research shows that obesity greatly increases the risk of developing asthma. Although~     the two conditions are clearly related, experts do not fully understand why they are linked.~     Some researchers believe that hormones released in the fat cells (adipokines) play a role.~     Others believe that excess weight pressing on the lungs triggers the hyperreactive response~     in the airways that is typical of asthma.~      The goal of the Asthma-Bariatric Surgery Study is to determine how weight loss affects lung~     function and various biological parameters. Bariatric (weight loss) surgery refers to the~     various surgical procedures performed to treat obesity. Specifically, this study is designed~     to answer the following questions:~        -  Does bariatric surgery help patients control their asthma?~        -  How much asthma control can be achieved through weight loss?~        -  How does weight loss influence lung function?~      Participants in this observational research study will be asked to complete study visits at~     enrollment, 1 month, 6 months, and 12 months. Questionnaires, pulmonary function tests, and~     blood samples will be required at each time point.~      This research study is observational only; it does not cover the cost of (or provide)~     bariatric surgery. Optional genetic and bronchoscopy substudies are included as well.~   "
224831|NCT00615485|"~     Specific subgroups of children who survive treatment for childhood malignancies have been~     shown to develop relative osteopenia following chemotherapy and are felt to be at risk for~     developing osteoporosis later in life due to their inability to reach peak bone mass during~     childhood. Based upon an earlier study in our department, the investigators reported~     conclusive evidence that approximately half of survivors of pediatric solid malignancies are~     at risk for these problems. However, the proportion of patients in our population that showed~     osteopenia/osteoporosis was lower than that in other similar cross-sectional studies in solid~     tumors such as osteosarcoma. The main difference between our report and the osteosarcoma~     study was duration of follow-up, with ours being shorter. Longer follow-up may prove that a~     larger proportion of our patients are affected. The purpose is to perform a longitudinal~     follow-up study of bone mineral density using dual-energy X-ray absorptiometry (DXA) in adult~     survivors of solid pediatric tumors that were previously studied as subjects in our original~     cross-sectional study. The primary hypothesis is that the proportion of pediatric solid~     cancer survivors with significantly lower bone mineral density (BMD) compared to established~     age group controls will be increased with the additional time that has elapsed since the~     original study despite the fact that the patients are young and would not normally be~     expected to have osteopenia/osteoporosis at this age.~   "
224832|NCT00615472|"~     Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients~     over the age of 65. Given their age and frailty, these patients frequently require surgical~     procedures with general anesthesia. However, after surgery, patients with Parkinson's disease~     have longer hospital stays and a greater chance of not returning to independent living~     compared to age-matched controls (Berman MF, unpublished data). In part, this is due to a~     higher rate of post-operative delirium, which had an incidence of 60% in this population in~     one study. There is anecdotal evidence from neurologists specializing in movement disorder~     suggesting that there is also significant deterioration in parkinsonian motor symptoms and~     cognition lasting for months or years following surgery and anesthesia. The basis for this~     deterioration is unknown. We hypothesize that these problems are caused by particular~     medications used during inhaled anesthesia for surgical procedures.~   "
224833|NCT00615459|"~     The study compared the 24-hour spirometry profile of indacaterol with that of placebo and~     with tiotropium as an active control in patients with chronic obstructive pulmonary disease.~   "
224834|NCT00615446|"~     This study assesses the maximum tolerated dose, overall safety and antitumor activity of~     SU011248 in combination with gemcitabine in patients with advanced solid tumors~   "
224835|NCT00615433|"~     Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical~     study is designed to test the hypothesis that lurasidone is more efficacious than placebo.~     The study will also evaluate the safety and tolerability of lurasidone as compared to~     placebo.~   "
224836|NCT00615420|"~     The primary hypothesis of this study is that regular topical oral application of Manuka Honey~     will reduce the severity and duration of oral mucositis in patients who are undergoing~     mucotoxic radiation therapy for cancer treatment.~   "
224837|NCT00615407|"~     Since 1980, the number of people in the United States diagnosed with asthma has increased~     dramatically. Studying what causes and triggers asthma is an important part of understanding~     and subsequently managing this disease. Although some have suggested that alcohol consumption~     may affect asthma, little is known about how consistent alcohol use affects the amount of~     inflammation present in the lungs and whether consistent alcohol use makes the airways more~     narrow and stiff.~      Participation in this study involves 2 visits in order to complete questionnaires, various~     pulmonary function tests, as well as the collection of blood, urine, and exhaled breath~     condensate specimens.~      This study includes optional genetic and bronchoscopy substudies.~   "
224838|NCT00615394|"~     Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating~     ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This~     study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up~     to one year after the procedure.~   "
224839|NCT00615381|"~     We hypothesize that in patients undergoing surgical treatment of unruptured intracranial~     aneurysms, the increase in blood sugar as a result of surgical stress is detrimental to~     outcome, as measured by blood levels of proteins associated with systemic inflammation and 7~     day, 90 day, and 1 year postoperative neurologic and neuropsychiatric outcomes. Because~     insulin itself is an anti-inflammatory agent, we anticipate that normalizing blood sugar~     levels with insulin doses higher than normally produced by the body (i.e., supraphysiologic~     insulin doses) will have a greater benefit on these outcomes than equally normalizing blood~     sugar levels using normal insulin doses. Based on the results of this study, we will be able~     to determine if a more laborious strategy to normalize blood sugar levels (i.e.,~     supraphysiologic insulin therapy) offers any additional benefits to normal insulin dosing~     strategies. In addition, we will obtain a robust assessment of postoperative neuropsychiatric~     and neurologic outcomes of surgically repaired unruptured intracranial aneurysms that will~     serve as the basis for future studies to decrease morbidity of these patients~   "
224840|NCT00615368|"~     The purpose of the trial is to determine if erythropoietin (EPO) can enhance cognitive~     function during hypoglycaemia in patients with type 1 diabetes.~      Patients with type 1 diabetes will receive one injection of EPO. Hypoglycaemia will be~     induced 6 days after. Before (1 hour), during and after (1 hour) hypoglycaemia, the cognitive~     function will be measured.~   "
224841|NCT00615355|"~     The effect of treatment with narrow-band UVB 311 nm after transplantation of harvested~     autologous epidermal cells on vitiligo lesions will be investigated.~   "
224842|NCT00615329|"~     Bone and soft tissue sarcomas are currently classified based upon light microscopy~     supplemented by immunohistochemistry, but within many if not all of these tumor histologic~     types, considerable heterogeneity exists not only in microscopic appearance but also in~     biologic behavior and prognosis. Progress in the directed treatment of these tumors,~     particularly the sarcomas, awaits characterization of the gene profiles for these tumors.~     Orthopedic oncology researchers at Huntsman Cancer Institute at the University of Utah are~     establishing a tumor bank for this purpose. The long term objectives of this work include:~        1. creating tumor specific gene profiles to improve diagnostic accuracy~        2. performing gene set validation for diagnostic predictive power~        3. defining a discriminate gene list implicated in pathogenesis~      The tissue procured under this protocol at SUNY Upstate Medical University will be limited to~     excess soft tissue and bone tumor tissue from patients otherwise undergoing clinically~     indicated procedures for diagnosis or treatment under the care of the local principal~     investigator (PI) and will be forwarded to the central investigator, R. Lor Randall, MD at~     Huntsman Cancer Institute for use in the characterization of the gene profiles of these~     tumors.~   "
224843|NCT00615316|"~     We hypothesize that Guaraná, a native plant from the Amazon, might improve radiation-induced~     fatigue in breast cancer patients undergoing treatment. In order to assess this, we~     randomized patients to either guaraná extract or to placebo, switching the assigned treatment~     mid-term through the radiation.~   "
224844|NCT00615303|"~     Sodium phosphate is one of the bowel preparation regimens for colonoscopy. However,~     intraluminal gas can impair visibility during the examination. Simethicone is medication that~     works by reducing the surface tension of air bubbles. We aimed to evaluate the effect of~     simethicone in enhancing visibility and efficacy during colonoscopy.~   "
224845|NCT00615290|"~     To obtain information on clinical practices for patients treated by Aptivus in real life~   "
224846|NCT00615277|"~     The study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty~     acids affects learning and mood of healthy young adults.~   "
224847|NCT00615264|"~     The purpose of this study is to determine if DiaPep277 can effectively protect the internal~     production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the~     immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the~     immune system and is expected to prevent further destruction of the beta-cells by stimulating~     regulatory responses, without causing immunological suppression.~   "
224848|NCT00615251|"~     This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone~     gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration~     will be approximately 12 months and will involve ovarian suppression/stimulation protocols as~     well as egg retrieval.~   "
224849|NCT00615238|"~     Although exercise is widely regarded as a key component in obesity treatment, few individuals~     seem able to adhere to exercise programs over time. In response, efforts have focused on~     developing new approaches to physical activity that may appeal to sedentary overweight~     persons. For instance, is has been shown that accumulating multiple short bouts of vigorous~     exercise may enhance both exercise adherence and weight loss in overweight persons.~     Accumulating moderate-intensity activity throughout the day may offer comparable health and~     weight benefits as a traditional exercise program. Public health recommendations now include~     the option of accumulating 30 minutes of moderate-intensity lifestyle activity for health and~     well-being. While these two options offer a viable alternative to those who dislike or cannot~     sustain continuous vigorous exercise programs, it is unclear whether the flexibility of~     accumulating physical activity or the vigorous intensity of the exercise is responsible for~     improved weight loss and long-term adherence.~      The goal of this research is to extend our preliminary findings suggesting that moderate~     intensity lifestyle activity is an important and viable alternative to traditional structured~     vigorous exercise for obese dieting individuals. The primary specific aim of this project is~     to compare the effects of three modes of exercise on long-term weight regain. Participants~     will be 165 overweight men and women who are sedentary, but otherwise healthy. All~     participants will receive the same 16-week behavioral weight loss program and will be~     randomized to one of three exercise study conditions: 1) diet-plus-continuous bouts of~     vigorous aerobic exercise; 2) diet-plus-short bouts of vigorous aerobic exercise accumulated~     throughout the day; or 3) diet-plus-moderate intensity lifestyle activity accumulated~     throughout the day. By varying both the intensity and duration of exercise bouts, we can~     determine which type of exercise is associated with optimal outcomes one year later.~     Additional questions of interest include:~        1. Does mode of exercise influence exercise adherence?~        2. Does mode of exercise improve cardiovascular risk profiles similarly in all three~          conditions?~        3. Does mode of exercise influence changes in body composition?~        4. Does mode of exercise influence exercise enjoyment and exercise self-efficacy?~   "
224850|NCT00615225|"~     We hypothesized that brain death is associated with an early systemic inflammatory response,~     possibly combined with activation of apoptotic cell death, two events that may contribute to~     induce rapid organ dysfunction. In this study of brain-dead donors and controls, we assayed~     plasma cytokines and soluble factors, investigated plasma endotoxin levels as a triggering~     factor for inflammation, measured ex vivo cytokine production by blood leukocytes to~     determine whether immunosuppression occurred after brain death, and examined skeletal muscle~     biopsies to look for evidence of inflammation and increased apoptosis in peripheral tissue.~   "
224851|NCT00615212|"~     This study is meant to assess potential inhibitory effects of GSK376501 on CYP450 isoenzymes~     3A4, 2C8, 2C9. subjects will receive probe compounds and systemic levels of these substrates~     will be compared pre and post dosing of GSK376501.~   "
224852|NCT00615199|"~     This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to~     severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be~     tested will be more effective than placebo (inactive drug).~   "
224853|NCT00615186|"~     The current study will investigate whether the addition of Neuradiab to surgery, radiation~     and adjuvant chemotherapy (temozolomide) will improve the survival of patients with~     glioblastoma and whether the drug regimen is safe.~   "
224854|NCT00615173|"~     The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous~     cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).~      To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy~     of LN(III,IV,V).~   "
224855|NCT00615160|"~     To evaluate the efficacy of PTK-ZK on metastatic melanoma either as a single agent treatment~     or in combination with standard chemotherapy according to RECIST criteria. Further to~     evaluate the safety and tolerability of PTK-ZK in patients with metastatic melanoma either as~     a single agent treatment or in combination with standard chemotherapy~   "
224856|NCT00615147|"~     The purpose of this study is to see if a blood test (D-dimer) is as precise as the CT scan~     for the detection of clots.~      A pulmonary embolism is an obstruction of the blood vessels in your lungs usually due to a~     blood clot that travels to the lungs usually from the leg. Research has shown that the~     results of a specific blood test (D-dimer) can be used instead of a CT scan to diagnose~     clots. D-dimer is a valuable diagnostic marker in either detecting the presence of or~     monitoring the progress of blood clots. D-dimer assays have proven to be a beneficial~     diagnostic tool in the evaluation of patients with suspected pulmonary embolism (PE).~   "
224857|NCT00615134|"~     This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon~      + optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with~     virological failure. Eligible patients will be randomized to recei ve either new optimized~     treatment alone, or optimized treatment + Fuzeon 90mg s.~      c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible~     for a patient to receive several additional 3 month periods with F uzeon, in the case of new~     virological failure. The anticipated time on study tre atment is 3-12 months, and the target~     sample size is <100 individuals.~   "
224858|NCT00615121|"~     Peripheral artery disease is a disease that contributes to significant morbidity and~     mortality of millions of Americans yearly. Very little is known about the pathophysiology of~     atherosclerosis in peripheral artery disease. We plan to collect peripheral arteries and~     muscle tissue from patients undergoing amputation for end stage peripheral arterial occlusive~     disease. By extracting the RNA from these arteries and tissues and comparing them with RNA~     expression from normal arteries, we hope to have a better understanding of the~     pathophysiology of atherosclerosis in this setting. We aim to prove the hypothesis that a~     novel gene expression pattern can be discovered by the successful extraction of RNA from~     plaques from human peripheral arteries.~   "
224859|NCT00615108|"~     The purpose of this observational study is to survey the safety and effectiveness of the~     product under the real condition of usual practice in Taiwanese hypertensive patients. During~     the 8-week observation, the safety profiles and the clinical evaluation in between doses~     through blood pressure (BP) measurement for overall effectiveness of telmisartan therapy will~     be concluded.~   "
224967|NCT00613600|"~     Overweight and obesity are serious and growing problems within the United States. The usual~     approaches to weight loss-dieting, exercise, and behavioral interventions-rarely result in~     long-term weight loss. Therefore, we will evaluate the safety and efficacy of glucomannan, a~     fiber supplement that has promising weight loss effects.~   "
224860|NCT00615095|"~     The goal of this study is to find out if some people are more likely to get melanoma, a form~     of skin cancer, than others. People respond to the environment in different ways. Some may be~     born with genes that make them more likely to get this type of skin cancer. Genes are made up~     of DNA. DNA damage is one of the first steps in developing cancer. Each person has many ways~     to repair normal damage to their genes. Some people may have a lower level of this repair and~     that may make them more likely to get cancer. Some genes are important for DNA repair. The~     genes we want to test are thought to affect the rate at which DNA can be repaired. We also~     want to find out if sun habits are related to these levels of DNA repair or genetic~     mutations.~   "
224861|NCT00615082|"~     The primary goals of this exploratory/developmental (R21) study are to evaluate the~     feasibility and acceptability of a MBSR intervention for caregivers of patients with~     dementia, and to estimate the effectiveness of program outcomes on standardized measures of~     perceived stress, psychological distress and caregiver burden. We will randomize 60~     caregivers 1:1 to participate in: 1.) an intervention arm consisting of a MBSR program that~     includes 8 weeks of group instruction in mindfulness meditation techniques followed by home~     practice, or 2.) an active control arm consisting of a standard 8 week Community Caregiver~     Education and Support (CESS) program.~      We anticipate that caregivers will be interested in participating in the intervention, be~     open to randomization, and have good rates of compliance with the program. It is also~     expected that MBSR program participants will evidence a trend toward better outcomes than~     CESS participants on primary outcome measures of perceived stress, psychological distress and~     perceived caregiver burden.~      Substudy The purpose of this proposal is to add a physiologic outcome sub-study to the~     Balance project that will examine four biological markers correlated with stress in~     caregivers participating in the study intervention. The Balance Study is a recently funded~     NIH randomized controlled pilot study to evaluate the acceptability and feasibility of a~     Mindfulness-Based Stress Reduction (MBSR) intervention for caregivers of patients with~     dementia. Balance is randomizing caregivers (N=60) into equal numbers to participate in~     either an intervention arm consisting of a MBSR program that includes eight weeks of group~     instruction in mindfulness meditation techniques followed by home practice or an active~     control arm consisting of a standard eight week community Caregiver Education and Social~     Support (CESS) program. The specific aims of this study are to: 1) evaluate the feasibility~     of adding physiologic markers to the Balance Study; 2) examine changes over time in~     individual study participants on four biological markers correlated with stress including~     interleukin 6 (IL-6), D-dimer, DHEA-S and telomere length; and 3) to examine preliminary~     differences between MBSR and CESS groups on four biological markers. The addition of~     physiologic outcomes to the Balance Study presents an emerging opportunity to increase the~     competitiveness for our NIH R01 application.~   "
224862|NCT00615069|"~     The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER®~     AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms~   "
224863|NCT00615056|"~     The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or~     FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying~     tumor progression in the second-line treatment of patients with metastatic colorectal cancer~     after failure of an irinotecan or oxaliplatin-containing first-line regimen.~   "
224864|NCT00615043|"~     The objective of the study is to obtain bladder tissue specimens from patients otherwise~     undergoing cystoscopy for use in research at Tengion, Inc.~   "
224865|NCT00615030|"~     This study was conducted to provide detailed information on the efficacy of indacaterol (in~     terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full~     24-h time period~   "
224866|NCT00615017|"~     This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the~     safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending~     intravenous infusions of CytoFab (AZD9773) in adult patients with severe sepsis.~   "
224867|NCT00615004|"~     A direct comparison between the results of surgery or somatostatin analogues (SSA) on~     cardiovascular complication in acromegaly has never been performed.~      Our objective is to investigate whether first-line surgery or SSA have a different outcome on~     cardiomyopathy after 12 months. The design of the study is retrospective, comparative, non~     randomized, because of ethical problems.~      Setting University Hospital. All patients treated with SSA [either octreotide-LAR (10-40~     mg/q28d), or lanreotide (30-120 mg/q28d); dosages up-titrated to control GH and IGF-I levels]~     or operated on by transsphenoidal approach. For the purposes of this study only controlled~     patients will be included.~      Measurements Primary outcome measures were changes in left ventricular mass index (LVMi),~     diastolic [early to atrial mitral flow velocity (E/A)] and systolic perform-ance [LV ejection~     fraction (LVEF)]. Secondary outcome measures were reduction of total/HDL-cholesterol ratio,~     as a cardiovascular (CV) risk parameter, improvement of glucose profile and pituitary~     function, as indirect causes of CV improvement.~      Expected results: SSA and surgery groups should have similar results in terms of improvement~     of cardiomyopathy. However, recent data suggest that SSA reduce directly heart rate and~     cardiomyocytes performance: clinical implications of these evidences suggest that SSA will~     improve cardiovascular outcome more than surgery. Moreover, after surgery, replacement~     therapy already stabilised or of new onset, has never been considered so far in this setting.~   "
224868|NCT00614991|"~     To date, no study has investigated whether there is a drug interaction between the protease~     inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL111242 is a randomized,~     open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir~     (APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, HIV-negative adults after~     administration of a 7-day regimen of RTG 400mg twice a day (BID) alone and after 14-day~     regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/Ritonavir (RTV)~     100mg BID, or FPV 1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent~     RTG 400mg BID. Blood samples for drug concentration measurement will be collected over 12~     hours at the end of each dosing period. Subjects will undergo a physical examination,~     complete blood count (CBC) with differential, HIV test, hepatitis B/C test, liver function~     test, renal function analysis, and lipid panel at screening, and all of these tests, except~     those for HIV and hepatitis B/C, will be repeated at follow-up post-study. Adverse events and~     adherence (by pill count and medication diary) will be assessed by the investigator/study~     personnel at the end of each dosing period~   "
224869|NCT00614978|"~     Objectives:~      Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting~     toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary~     information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain~     metastases secondary to HER-2 positive breast cancer including Objective Response Rate (ORR),~     Clinical Benefit (CB) and Duration of Response (DR)~      Methodology:~      Phase I, single-centre, open-label, dose-escalation study of combining lapatinib and~     temozolomide in HER-2 positive breast cancer patients with progressive brain metastases after~     surgery or radiotherapy or radiosurgery~      Treatment:~      Temozolomide will be given orally for 5 days of every 28 days, at doses of either~     100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at~     either 1000mg/day or 1250mg/day or 1500mg/day.Sequential cohorts will be escalated in~     increments according to the dose escalation scheme, and determined by dose limiting~     toxicities.~   "
224871|NCT00614952|"~     The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to~     the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it~     could be an alternative to conventional polysomnography. Objectives: 1) Usefulness of~     domiciliary study evaluated by percentage of patients diagnosed of SAHS compared with PSG and~     agreement in the therapeutic decision. 2) Direct costs of patients included in the study.~     Design: controlled, randomized, crossed and blind (320 patients) comparing PR made at home~     with PSG, in patients suspicious of SAHS. The equipment transfer will be made by a transport~     agency from home to home in order to be universal the access to this diagnostic model. The~     file transmission with the raw data of the study will be made telematically by GPRS. If the~     aims of the study reach an end there will be a considerable change in the clinical practice~     making possible the international acceptation of domiciliary PR as diagnosis of SAHS and~     adapting the diagnosis of this syndrome to the new technologies of communication. The~     universalization of domiciliary PR would make possible that the diagnosis of SAHS could be~     done in any patient and in any country with GPRS technology and a transport agency, that is~     to say in all developed countries. As sleep apneas affect 5-7 million persons in Spain and~     there is association between sleep apneas and cardiovascular risk, in the immediate future we~     must evaluate this disease as we do today with the cholesterol determination. If our results~     are as predicted, the primary care physician could start and in a lot of cases finish the~     SAHS diagnostic process. This would simplify remarkably the diagnosis of SAHS and would~     alleviate a lot the process cost all over the world.~   "
224872|NCT00614939|"~     Saxagliptin is a new investigational medication being developed for treatment of type 2~     diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally~     impaired patients.~   "
224873|NCT00614926|"~     The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating~     fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic~     lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.~   "
224874|NCT00614913|"~     This study is designed to evaluate the possible benefits and side effects of the use of~     proton therapy for patients with hepatocellular carcinoma.~   "
224875|NCT00614900|"~     The prevalence of an increased pulmonary blood pressure amongst patients with chronic~     obstructive pulmonary disease (COPD)is unclear. So is the impact of abnormal pulmonary blood~     pressure on symptoms. The aim of this study is to determine the prevalence of an increased~     pulmonary blood pressure in 200 patients with COPD. Furthermore we will investigate if lung~     function test results and blood tests can predict an increased pulmonary blood pressure, and~     explore whether COPD patients with a high pulmonary blood pressure have more symptoms that~     their co-patients.~   "
224876|NCT00614887|"~     Subarachnoid haemorrhage (SAH) may cause damage to the hypotalamo-pituitary-adrenal axis~     (HPA) thus disturbing the hormonal response of these structures.~      The aim of our study is to characterize the function of HPA-axis acutely and over time up to~     three months in patients with SAH.~   "
224877|NCT00614874|"~     Asthma is a common chronic disease characterized by airway inflammation and~     bronchoconstriction. This study utilizes the drug rosiglitazone (Avandia)to treat the effects~     of airway inflammation in patients with asthma.~      The study will be conducted on 14 adult steroid naive patients with asthma. Patients with~     qualifying pulmonary function testing values will be eligible for enrollment. Enrolled~     subjects will be treated with rosiglitazone orally at 2mg dose for 4 weeks. Patients will be~     reassessed and dosing will increase in 4 week increments up to 8mg.~   "
224878|NCT00614861|"~     The purpose of this study is to survey pain management satisfaction in patients with~     non-cancer pain.~   "
224879|NCT00614848|"~     To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm~     ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in~     native coronary arteries 2.25-3.5 mm in diameter.~   "
224880|NCT00614835|"~     This is a pilot study of adjuvant therapy for patients with leiomyosarcoma of the uterus that~     has been completely removed by surgery. Adjuvant therapy means that the tumor (the~     leiomyosarcoma) has been completely removed by surgery; thus, giving further treatment now is~     done in hopes of decreasing the chance that the tumor will come back (relapse or recur). The~     main goal of this study is to show that this series of treatments is safe for patients with~     your type of tumor.~      In this trial you will be getting drugs that have been approved for use in some types of~     cancer. In this study we wish to see whether the combination of two chemotherapy drugs,~     docetaxel and gemcitabine can decrease the chance of your tumor, leiomyosarcoma of the~     uterus, from coming back (relapsing). We will also be looking at the short-term side effects~     and risks of the drugs given in this combination to patients with leiomyosarcoma that has~     been completely resected (removed by surgery).~      The combination of gemcitabine and docetaxel has been shown to be safe, and it has been shown~     to decrease the size of leiomyosarcoma tumors in patients with leiomyosarcoma of the uterus~     that has relapsed, or has continued to grow despite treatment with other chemotherapy drugs.~   "
224881|NCT00614822|"~     The purpose of this study is to look for an improvement in progression free survival with the~     combination of bevacizumab, carboplatin and pemetrexed in patients with newly diagnosed~     advanced/metastatic non small cell lung cancer. Overall survival and safety will also be~     assessed.~   "
224882|NCT00614809|"~     This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and~     toxicity of gefitinib in patients with asymptomatic advanced NSCLC who was benefitted by~     first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain~     metastasis who was benefitted by first line chemotherapy will receive oral gefitinib 250mg~     once daily until disease progression or unacceptable toxicity. These patients' direct DNA~     sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by~     RECIST criteria after the patient received gefitinib 6 weeks.If the patients present with~     progress disease of brain metastasis after the therapy of gefitinib, the patients will~     receive irradiation of brain metastasis.If the response is stable disease,partial response or~     complete response,he will be examined by brain MRI every 12 weeks.~   "
224968|NCT00613587|"~     This study is looking for allergic asthmatics. Lung and allergy testing will be done to~     verify. If qualified, blood will be drawn for laboratory studies.~   "
224883|NCT00614796|"~     Chronic Obstructive Pulmonary Disease (COPD) is increasing in the Netherlands. COPD is~     characterized by a deterioration of lung function, a lowering physical activity level and a~     low state of quality of life.~      The aim of this randomized controlled study is to investigate the effects of a structured~     lifestyle program compared with usual care (in the first, second and third echelon) on the~     physical activity level of COPD patients.~      150 COPD patients (GOLD I-IV) will be included, aged between 40 and 80 years. In each echelon~     25 patients will participate in a structured lifestyle program and 25 patients will be~     treated with usual care.~      In the structured lifestyle program, patients will be stimulated individually to enhance a~     physically active lifestyle. The primary outcome parameter is daily physical activity (steps/~     day) assessed with a pedometer.~      According to the study protocol patients in the experimental group and the control group~     participate in four measurement sessions distributed over 15 months. In each assessment a~     physical fitness test, lung function and questionnaires are taken. Patients of the~     experimental group participate in five individual counseling sessions and one telephonic~     counseling.~   "
224884|NCT00614783|"~     This is a pivotal study to determine the accuracy of a new device (SCOUT) in screening~     persons for pre-diabetes or diabetes. SCOUT will be compared to the standard screening test~     (Fasting Plasma Glucose), using the Oral Glucose Tolerance Test as the reference standard.~      SCOUT uses a rapid, noninvasive, light-based technology to measure the concentration of~     chemicals in the skin called advanced glycation endproducts (AGEs). Several studies have~     demonstrated that AGEs accumulate in skin faster in individuals with poor control of blood~     sugar.~      Persons will be eligible for the study if they are 'at risk' for diabetes based on their age~     and other risk factors as defined by the American Diabetes Association.~   "
224885|NCT00614770|"~     In this study the investigators hypothesize that High Definition White Light colonoscopy and~     narrow band imaging (NBI) will detect a higher number of adenomas compared to standard~     definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp~     histology compared to high definition colonoscopy and standard colonoscopy.~      Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy,~     high-definition white light colonoscopy and NBI.~      Specific Aim 2 - To compare the number of adenoma detected per subject by standard~     colonoscopy, high-definition white light colonoscopy and NBI.~      Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard~     colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface~     mucosal and vascular patterns during the procedure.~      Specific Aim 4 - To determine the inter-observer agreement between investigators for the~     recognition of various polyp patterns~   "
224886|NCT00614757|"~     The purpose of this study is to evaluate how often patients with hepatitis C infection have~     abnormalities of sugar and fat utilization. Additionally we would like to find out if these~     abnormalities of sugar and fat utilization are common in other liver diseases, or related to~     being overweight.~   "
224887|NCT00614744|"~     This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced~     whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in~     infants ≥ 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the~     incidence of death or disability at 18-22 months of age. The study will enroll 168 infants~     with signs of hypoxic-ischemic encephalopathy at 16 NICHD Neonatal Research Network sites,~     and randomly assign them to either receive hypothermia or participate in a non-cooled control~     group.~   "
224888|NCT00614731|"~     Atopic dermatitis (AD) is a skin disorder in which people often have swelling and skin~     infections. People with this disease cannot receive the smallpox vaccine because it could~     cause them to have a fatal reaction known as eczema vaccinatum (EV). Keyhole limpet~     hemocyanin (KLH) is a protein that can be used to deliver vaccines to the body. The purpose~     of this study is to determine a baseline immune reaction to KLH in people without AD. Once~     this has been established, other studies can be designed to determine whether KLH can be used~     to give vaccines to people with AD.~   "
224889|NCT00614718|"~     Comparison of two different approaches to address the problem of malfunctioning ICD-leads.~     These leads consist of two parts. One that is used for detection of arrhythmias(and pacing if~     required) (Pace/Sense) and a second part that is used to deliver therapy is needed~     (Shock-coil).~      The two approaches compared are:~      Replacement of the entire lead in case of any lead malfunction versus placement of an~     additional pace/sense-lead if the shock-coil of the exiting lead was still functional.~   "
224890|NCT00614705|"~     This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain~     associated with post-herpetic neuralgia. Suitable patients will be randomized to receive~     either PH-797804 or placebo for 4 weeks, during which time they will also record their pain~     symptoms using various pain scales.~   "
224891|NCT00614679|"~     The primary objective is to investigate the ability of systemic intravenous antibiotic plus~     antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating~     uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter.~     Secondary objectives include duration to clearance of bacteremia, future recurrence of~     bacteremia, need for catheter removal and death.~   "
224892|NCT00614666|"~     The purpose of this study is to determine if nikkomycin Z is safe when administered at~     different dose levels for 14 days. The study will also determine blood levels and urinary~     excretion of nikkomycin Z in relation to dose administered. Patients with mild forms of~     Valley Fever pneumonia will be eligible to participate and will be allocated to receive~     treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is~     to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.~   "
224893|NCT00614653|"~     The goal of this clinical research study is to find the highest tolerable dose of~     capecitabine, erlotinib hydrochloride, and bevacizumab that can be given in combination with~     radiation to patients with pancreatic cancer.~   "
224894|NCT00614640|"~     The therapeutic DNA vaccine, DermaVir, represents an immunization strategy that targets lymph~     node dendritic cells. Because of the high percentage of naive CD4 cells in children and~     adolescents, the potential for effective new HIV-specific CD4 cell responses may be more~     achievable in children than in adults. The primary purpose of this study is to evaluate the~     safety and tolerability of DermaVir in children and young adults.~   "
224895|NCT00614614|"~     The purpose of the study is to characterize the immunogenicity & safety of a booster dose of~     GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months~     of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's~     Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and~     open-label for the booster phase.~   "
224896|NCT00614601|"~     To assess the response for subjects with pancreatic cancer that have undergone surgical~     resection and treatment with a vaccine given with or without chemotherapy and chemoradiation.~   "
224897|NCT00614588|"~     This study will evaluate the accuracy of several thermometers and temperature changes during~     surgery and immediately after surgery.~   "
224898|NCT00614575|"~     The primary objective of this investigation is to conduct a 12-week prospective survey in PD~     patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as~     this drug) in the routine clinical settings to determine the following items related to the~     safety and efficacy.~      i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the~     investigation iii. Depressive symptoms during the investigation~   "
224899|NCT00614562|"~     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA~     delivers assist to spontaneous breathing based on the detection of the electrical activity of~     the diaphragm. We study the effect of NAVA in patients with critical illness associated~     polyneuropathy / polymyopathy (CIP/M)~   "
224900|NCT00614549|"~     To evaluate, over 1 year period, the efficacy and safety of newly prescribed levetiracetam as~     add-on treatment (POS, myoclonoc seizures in JME and PGTCS in IGE) or primary monotherapy~     (partial onset seizures) in adult and paediatric patients within the approved age limits in~     routine clinical practice in Czech and Slovak Republics, Hungary, and Romania.~     Non-interventional study.~   "
224901|NCT00614536|"~     The purpose of this observational study is to examine RSI (Reflux Symptom Index) and RFS~     (Reflux Finding Score) by treatment period before and after rabeprazole treatment in~     LaryngoPharyngeal Reflux Disease(LPRD) patients.~   "
224902|NCT00614523|"~     The Data Monitoring Committee (DMC) for study 20060198 recommended that all subjects~     discontinue treatment of study drug and continue to be followed for long term follow-up.~     Amgen adopted the DMC recommendation.~   "
224903|NCT00614510|"~     The purpose of this study is to demonstrate that the results achieved in the original pivotal~     clinical investigation of 81 subjects from five clinical sites are generalizable to new~     clinical sites that complete the staff training defined in the SynCardia Systems, Inc.~     Training Manual and who enroll subjects who meet the intended use defined in the product~     Instructions for Use.~   "
224904|NCT00614484|"~     The purpose of this study is to determine the effectiveness of proton beam radiotherapy~     combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.~   "
224905|NCT00614471|"~     This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination~     therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be~     randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180~     micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36~     or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from~     week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The~     anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for~     group 3, and the target sample size is 100-500 individuals.~   "
224906|NCT00614458|"~     The purpose of this research study is to see if HIV that persists despite current antiviral~     therapy can be targeted by new treatments. We will see if adding Raltegravir (MK-0518) and~     Valproic acid (VPA) to current ART can decrease the amount of latent HIV.~   "
224907|NCT00614445|"~     The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg~     and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of~     pregnancy than a placebo.~   "
224908|NCT00614432|"~     The primary objective of this study is to compare blood loss resulting from surgical~     termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to~     therapeutic levels and those who are not anticoagulated. This study is based on the~     hypothesis that anticoagulant therapy does not increase intraoperative blood loss in women~     receiving surgical abortions up to 12 weeks gestation.~   "
224909|NCT00614419|"~     To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES~     soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure~     performed with polypropylene mesh.~   "
224910|NCT00614406|"~     The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor~     will result in premature luteolysis (ovulation failure) in women.~   "
224911|NCT00614393|"~     This study will compare the safety and efficacy of dalotuzumab (MK-0646) in combination with~     cetuximab and irinotecan in treating participants with wild type KRAS (wtKRAS) metastatic~     colorectal cancer (CRC) compared to cetuximab and irinotecan alone.~      The primary study hypothesis is that administration of dalotuzumab in combination with~     cetuximab and irinotecan to participants with metastatic CRC expressing the wtKRAS genotype~     improves Overall Survival OR Progression-free Survival compared to participants treated with~     cetuximab and irinotecan alone.~   "
224912|NCT00614380|"~     The primary objective of this trial is to assess the efficacy and safety of the fixed dose~     combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5~     mg (T80/A5) during long-term open-label treatment.~   "
224913|NCT00614367|"~     Optimise genetic screening of human embryos using higher resolution techniques~   "
224914|NCT00614354|"~     The purpose of this clinical trial is to study the ability of a radioactive drug called~     Technetium Glucarate to detect whether the cause of chest pain in patients entering the~     emergency department with no obvious signs of heart attack is due to a condition called Acute~     Coronary Syndrome (ACS). The drug will be injected intravenously. After one or two hours the~     patient will undergo an imaging procedure to detect if the drug has accumulated in the heart.~     Uptake of the radioactive drug in the heart is indicative of reduced blood flow to the heart.~   "
225097|NCT00611884|"~     This trial is conducted in Africa, Asia and North America. The aim of this trial is to~     compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin~     glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.~   "
224915|NCT00614341|"~     To determine if pulsed electric field therapy reduces lower leg and foot pain associated with~     diabetic neuropathy and lessens the need for medication.~      The MedRelief device sends a sub-threshold electric signal through the skin using electrodes~     as means of signal delivery. The signal or waveform, frequency and strength were created to~     match the characteristics of signals the body generates to help natural healing.~   "
224916|NCT00614328|"~     The purpose of this research study is to learn about the use of a combination of two~     medications, baclofen and naltrexone, for the treatment of alcohol dependence in men and~     women ages 25-60 years old. Naltrexone is an FDA approved medication for treatment of alcohol~     dependence. The most widely accepted idea for naltrexone's effect is that it reduces the~     alcohol high, which decreases a desire to consume alcohol. As a result, alcoholic patients~     treated with naltrexone are less likely to relapse to heavy drinking. Furthermore, naltrexone~     treated patients drink fewer days and are more likely to maintain abstinence.~      However, naltrexone does not have any effect on other symptoms that may contribute to relapse~     such as anxiety, sleep problems and irritability. Baclofen, an FDA approved medication for~     muscle spasms, may improve some of these symptoms.~      Therefore, the purpose of the current study is to gather information on whether adding~     baclofen to naltrexone is feasible and well tolerated.~   "
224917|NCT00614315|"~     The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™~     Delivery System.~   "
224918|NCT00614302|"~     Data collection for better patient characterization in a highly treatment experienced~     population. Studying the clinical practice for the treatment of HIV multiexperienced patients~     in the real life.~      The research will be divided into two phases:~        -  The first phase intends to define and understand the clinical practice using a~          questionnaire about general topics: definitions of multiexperienced patients and VL~          failure, therapeutic strategies and behaviour in particular cases.~        -  The second part of the research will collect the clinical data of double PIs failure~          patients.~   "
224919|NCT00614289|"~     This study is designed as a prospective, randomized, double-blind right/left comparison of~     Epikeia coatings to improve hand dermatitis.~   "
224920|NCT00614276|"~     The goal of this psychosocial research study is to learn whether a website program called~     Tendrils: Sexual Renewal for Women after Cancer  may help female cancer survivors improve~     their sex lives when used either as a self-help tool or in combination with brief sexual~     counseling by a health care professional.~      Objectives:~      Sexual dysfunction is the most common long-term consequence of cancer treatment, affecting~     half of survivors of breast and gynecological cancer and many women treated for other~     cancers. Yet, few women get the help they need for sexual problems. Our primary objective is~     to develop and evaluate a multimedia intervention program for women with cancer-related~     sexual dysfunction. Tendrils: A Sexual Renewal Program for Women Surviving Cancer will: 1)~     explain the causes of cancer-related sexual dysfunction; 2) offer self-help strategies to~     prevent or overcome problems; 3) advise women on seeking appropriate medical help; and 4)~     possibly serve as the core of a counseling program, along with a therapist manual. Tendrils~     is aimed at a wide audience, from newly diagnosed to long-term survivors, across cancer~     sites. Material will be presented with sensitivity to religious and cultural attitudes about~     sexuality. Animations will illustrate anatomy and physiology. The software will let women use~     Tendrils in a variety of formats: over the internet, on a CD-Rom, printed out, or as~     downloaded digital video or audio on a handheld computer or media player. Video vignettes~     will illustrate problems and strategies. Five female cancer survivors will host the program,~     sharing their experiences.~   "
224921|NCT00614263|"~     Examine levels of sedation required for patients to comfortably undergo colonoscopy using~     propofol and if adjunct monitoring equipment promotes patient safety.~   "
224922|NCT00614250|"~     The primary objective of this study is to assess the activity of 4 escalating doses of~     AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.~   "
224923|NCT00614224|"~     Aerobic treadmill exercise has been shown to improve walking, cardiovascular fitness and~     thereby risk factor profiles in chronic stroke patients (Macko et al., Stroke 2005). The~     proposed project is a randomized controlled trial in geriatric stroke patients with chronic~     disabilities to investigate potential mechanisms of treadmill therapy. The hypothesis is~     tested that 3-months of aerobic treadmill exercise induces structural brain plasticity and~     reorganization. The outcome measures are walking ability, gait pattern, cardiovascular~     fitness and brain morphology. This study will elucidate fundamental mechanisms of brain~     adaptations linked to task-repetitive aerobic lower extremity exercise. These mechanisms will~     not only lead to a better understanding but may also help to identify predictors of treatment~     response.~      40 patients aged over 60 years with lower extremity paresis after a first-ever clinical~     stroke longer than 6 months prior to study inclusion will be recruited from: 1) The Geriatric~     Rehabilitation Clinic at the Robert-Bosch Hospital in Stuttgart 2) the Dept of Neurology,~     University Hospital in Tübingen. Subjects will be randomized to 3 months progressive graded~     aerobic treadmill exercise training (TAEX; 3 times/week, duration 10-45 min) or an attention~     control group (CON). Because we expect that localization and size of stroke affect therapy~     outcomes, stratified randomization will be used to balance entry into groups.~      We hypothesize that 3 months of treadmill gait training but not conventional care leads to~     improvements of cardiovascular fitness and gait and to brain reorganization (structural~     plasticity) in regions in which functional adaptations have been demonstrated using fMRI in~     previous studies. The specific aims are:~        -  To assess reorganization by comparing cortical thickness, cortical density and fiber~          tract morphology before (time point 0), and after therapy (3 months) using T1-weighted~          3D-MPRAGE images, voxel based morphometry and diffusion tensor imaging.~        -  To correlate brain reorganization with improvements in walking velocity, and analysis of~          gait patterns (parameters, swing time, stance time, gait symmetry).~        -  To correlate brain reorganization with location and size of the index stroke lesion and~          of diffuse white matter damage (subcortical vascular encephalopathy). Lesion and white~          matter damage will be evaluated based on T2-weighted FLAIR sequences.~   "
224924|NCT00614211|"~     The goal of this clinical research study is to compare the long-term outcomes of different~     surgical methods for the treatment of cervical cancer. The long-term outcome of a total~     abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study,~     the laparoscopy will be done with or without robotic technology.~   "
224969|NCT00613574|"~     At the moment, there is hardly any structured safety and efficacy data collection on~     Tiotropium in Russia. Therefore, the objective of this observational study is to collect and~     evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation~     capsules) delivered by HandiHaler®, in a national sample of Russian patients with varying~     severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8~     weeks.~   "
224970|NCT00613561|"~     The hypothesis of this study is that children with severe primary immunodeficiencies will~     benefit from early stem cell transplantation utilizing a reduced intensity conditioning~     regimen. This regimen is associated with a low risk of complications and will lead to~     correction of the underlying immunological defects.~   "
224925|NCT00614198|"~     A growing body of research indicates that dietary intervention excluding foods containing the~     proteins, gluten and casein, from the diet of children diagnosed with an autism spectrum~     disorder (ASD) may have a positive effect on behaviour and developmental outcome.~      In this single-blind, randomised-controlled, matched-pair adaptive trial, we introduced a~     gluten- and casein-free (GFCF) diet to a group of pre-pubescent children diagnosed with ASD~     concurrently with an abnormal urinary profile. Following random allocation to a diet or non-~     diet group, stage 1 of the study saw an intervention group follow the GFCF diet for eight~     months initially - progressing to 12 months if required. A non-diet control group continued~     with a normal diet.~      Assuming significant changes for the dietary group on the various outcome measures of~     behaviour and development, stage 2 of the study saw both groups assigned to GFCF dietary~     intervention for a further 12 months when outcome measures were again assessed at study end.~   "
224926|NCT00614172|"~     The purpose of this study is to determine if partial breast proton therapy is effective~     treatment for early stage breast cancer following lumpectomy.~   "
224927|NCT00614159|"~     Elective outpatient endoscopy for children can be safely performed under general anesthesia~     with either propofol (1) or ketamine (2) infusions. Both infusions have an advantage over~     general anesthesia with volatile agents because they do not require intubation. The goal of~     both infusions is to have the patient breath spontaneously without reacting to the endoscopy~     which is a noxious stimulus. Patient movement, stridor and vomiting are can interrupt the~     procedure and increase overall OR time. Propofol also carries the added risk of causing~     apnea. This side effect is not commonly seen with Ketamine. Our hypothesis is that Ketamine's~     profile makes it a superior drug to Propofol for elective outpatient endoscopy because of~     reduced profound intra-operative interruptions and faster recovery time. We plan a study of~     pediatric patients ages 1 to 10 years old undergoing elective outpatient endoscopy. The~     patients will be randomized to receiving either a Ketamine or Propofol infusion, and the~     intra-operative interruptions will be documented by the anesthesiologist. The Post Anesthetic~     Care Unit (PACU) time to recovery will be monitored and recorded by a third party.~   "
224928|NCT00614146|"~     The objective of this trial is to evaluate the impact of elimination of albumin bound~     substances during albumin dialysis (MARS®) on mortality and the clinical time course in~     patients with a recent severe clinical deterioration of chronic liver disease caused by a~     precipitating (trigger) event within 4 weeks manifested by jaundice, encephalopathy and/or~     renal failure.~   "
224929|NCT00614133|"~     Loss of muscle mass and body protein are the main causes of fatigue after bowel surgery,~     which may result in a longer hospital stay and a higher rate of complications. This~     particularly applies to malnourished patients with cancer who undergo surgery with less~     muscle protein reserves than patients who are well-nourished. Anesthesiologists can~     favourably influence these undesirable consequences of surgery by choosing the type of pain~     treatment, i.e. analgesia. Our group recently observed that pain treatment with epidural~     catheters (these are placed in the so called epidural space, which lies between the spine and~     the skin of the back), in contrast to the more conventional use of intravenous morphine, can~     prevent the loss of body protein after surgery.~      The goal of the present research program is to study whether this protein sparing effect of~     epidural analgesia can be further augmented if we feed our patients intravenously with~     glucose and protein starting the day prior to surgery. We believe that this new concept will~     not only avoid the increased protein loss after surgery, but will also help patients to build~     up new protein which is needed to fight the stress caused by the operation.~   "
224930|NCT00614120|"~     This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic~     control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes~   "
224931|NCT00614107|"~     A form of irregular heart rate called, Atrial Fibrillation (AF) is a major clinical problem.~     It afflicts about 2 million Americans and is the single largest heart related cause of~     stroke. However, despite 120 years of speculation and research, the mechanisms that cause AF~     are poorly understood. Acute AF is also the most common irregular heart rate after open-heart~     surgery in patients. This is seen in as many as 30% of such patients and often results in a~     longer hospital stay.~      In this study we would like to study the pattern of atrial fibrosis (scar tissue in the~     heart) and an associated blood marker (a protein called pro-collagen-1) in those patients~     concurrently having open heart surgery.~   "
224932|NCT00614094|"~     The purpose of this retrospective pilot study is to assess the association of maternal~     hypoglycemia during the one hour glucose tolerance test with decreased placental weight and~     identifiable placental pathology. We hypothesize that a decreased one hour glucose tolerance~     test is a risk factor for decreased placental weight, an increased fetal to placental weight~     ratio, and other identifiable placental pathology.~   "
224933|NCT00614081|"~     The aim of the study is to optimize and validate this MR-based GFR measurement in patients~     with a renal transplant, compared with the reference method, the Cr51- EDTA method: to select~     the most accurate combination of post-treatment of renal MR images and then evaluate its~     intra- and inter-rater reliability.~   "
224934|NCT00614068|"~     This study will compare the effectiveness of trauma-focused cognitive behavioral therapy~     versus standard care in treating children with post-traumatic stress disorder.~   "
224935|NCT00614055|"~     This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC,~     insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all~     in combination with metformin in insulin naive subjects with type 2 diabetes.~   "
224936|NCT00614042|"~     The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients~     with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical~     activity in patients with CLL and non-Hodgkin's lymphoma.~   "
224937|NCT00614029|"~     A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the~     Intraject system.~   "
224938|NCT00614016|"~     A safety and pharmacokinetic study of a single dose of ST20 in healthy volunteers~   "
224981|NCT00613405|"~     The purpose of this study is to explore the interaction between stress and marijuana cues, in~     hopes that it may lead to the development of new treatments for marijuana dependence.~   "
224982|NCT00613392|"~     Administration of antioxidants to trauma patients will improve measures of oxidant stress in~     the blood~   "
224939|NCT00614003|"~     Most dying cancer patients would prefer a home death yet die in an institution. Patients can~     experience uncertainty when weighing practical considerations, concern for others, and their~     personal ratings about the desirability and undesirability of various outcomes related to~     different locations of care. Health professionals, trained in decision support, can help~     patients to make decisions that are informed by both relevant information and what outcomes~     are most valued by patients. Therefore, I will study if an educational intervention can help~     nurses and case managers to strengthen their skills and confidence in providing patient~     decision support around place of end of life care.~      Project Description:~      Using a two step approach I will study if the quality of providers decision support can be~     improved with an education. In step one nurses and care coordinators will be interviewed to~     identify factors that make it easier or more difficult to provide patient decision support.~     This information will be used to develop an education program. In step two, nurses and care~     coordinator volunteers will be assigned by a flip of a coin to either receive the decision~     support education or not. Before and after the education program the quality of the decision~     support participants provide will be measured and compared. As well, participants receiving~     the education program will be asked about their satisfaction with the education program.~   "
224940|NCT00613977|"~     The investigators wish to compare the difference in both cost and time to result for~     determining fetal lung maturity for the Lamellar Body Count method and the Fetal Lung~     Maturity II. Our hypothesis is that the time to result will be significantly less using the~     Lamellar Body Count method, and the cost associated with this method over the traditional FLM~     II will be favorable.~   "
224941|NCT00613964|"~     Carperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in~     patients with heart failure through a vasodilatory action, a natriuretic action, and~     inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan.~     However, a paucity of report is available on the effects of carperitide on short and~     long-term prognosis in patients with both cardiac and renal failure. The purpose of this~     study is to evaluate the effects of carperitide therapy on short and long-term prognosis in~     patients with both cardiac and renal failure, in comparison with standard therapy.~   "
224942|NCT00613951|"~     This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble~     Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each~     other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive~     subjects with type 2 diabetes.~   "
224943|NCT00613938|"~     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety~     of the administration of 2 different dose levels of tapentadol (CG5503) compared with~     oxycodone and with placebo in subjects who have had a bunionectomy.~   "
224944|NCT00613925|"~     The purpose of this study is to determine the level of pain women experience during an~     endometrial biopsy and the effect that the biopsy tool might have on that pain. The~     investigators will also evaluate the adequacy of the sample each endometrial biopsy tool~     collects.~   "
224945|NCT00613912|"~     Depression is the most common psychiatric disorder.~        -  3-5% of a given population has major depression.~        -  Less than 50% of the depressed in Denmark are diagnosed with major depression.~        -  25-50% of the depressed have a relative with major depression-underlying brain~          pathology?~      The purpose of this study is to use MRI to evaluate cerebral morphology and function in~     ambulant patients with major depression~   "
224946|NCT00613899|"~     The investigators want to test feasibility of a structured program of telesurveillance and~     home cough assistance for ALS patients.~   "
224947|NCT00613886|"~     The research project is designed to determine which combination of tests will enable~     physicians to predict whether a patient with symptoms of normal pressure hydrocephalus (NPH)~     will improve with a shunt.~   "
224948|NCT00613873|"~     Colorectal cancer is a cancer in the colon or rectum. Routine screening can find it at an~     early stage, when it has a much higher chance of cure. Screening can also help to find~     polyps. These are mushroom shaped growths that could turn into cancer. A polyp can be removed~     before it turns into cancer. Even though screening can save lives, not enough people in the~     country are having it. This is especially true in Harlem. Harlem has a higher rate of deaths~     from this cancer than other places in the U.S. because too many people do not get screened.~     By the time a person has symptoms, the cancer may be at a late stage, when it is much harder~     to cure.~      We are doing this study to see if we can increase the number of people in Harlem who get~     screened. We plan to tell women about the screening when they have a mammogram or pap test.~     We will also ask them what they know and think about colorectal cancer. And, we will see if~     they get other members of their household to be screened.~   "
224949|NCT00613860|"~     Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until~     now the technique is limited to one lobe. In case of collateral ventilation patients show no~     improvement. Between upper and middle lobe exists the highest collateral flow. The trial~     examine the hypothesis, that sequential ELVR help especially those patients, which have no~     benefit after lobar exclusion.~   "
224950|NCT00613847|"~     The purpose of this study is to learn more about how a new study agent works inside the body.~     This study agent is a protein called 68Ga-F(ab')2-trastuzumab fragments (HERScan). This is a~     radioactive tracer that was developed at MSKCC to target the HER2 protein on cancer cells. By~     giving this tracer to patients whose cancers have the HER2 protein, we hope to be able to see~     the level of HER2 on the cancer cells using PET scanning.~   "
224951|NCT00613834|"~     The purpose of this study is to assess the level of pain women experience with an Essure~     procedure and the effect that lidocaine might have on that pain. We will also assess the~     absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.~   "
224952|NCT00613821|"~     The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside~     the uterus on patient pain during an early abortion, compared to the paracervical block~     (lidocaine injected on either side of the cervix).~   "
224953|NCT00613808|"~     The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the~     treatment of venous ulcers of the lower leg.~   "
224983|NCT00613379|"~     The purpose of this study is:~        1. To assess and characterize the PK and PD of PRO 140 administered IV~        2. To assess the antiviral activity of PRO 140~        3. To assess the safety and tolerability of PRO 140~   "
224955|NCT00613782|"~     In men with type 2 diabetes, low testosterone levels have been associated with insulin~     resistance, truncal obesity and symptoms such as fatigue and erectile dysfunction. Low~     testosterone may impair cardiac function and increase cardiovascular risk and cause~     osteoporosis. The goal of this project is to assess prospectively whether, in men with type 2~     diabetes mellitus and low testosterone levels, testosterone replacement improves insulin~     resistance, body composition, bone density, cardiac function symptoms associated with low~     testosterone level.~      The investigators will recruit 140 ambulatory men with type 2 diabetes and a low serum~     testosterone level (<10 nmol/L) from Austin Health Endocrine clinics, General Practise~     surgeries, and from the general public by direct consumer advertising via newspaper and other~     local media. Men will be randomised to either intramuscular testosterone undecanoate~     (Reandron 1000, Bayer Schering Pharma) or placebo. Men with contraindications to testosterone~     replacement or to intramuscular injections will be excluded from the study. All men will~     receive intramuscular testosterone or placebo injections at 0, 6, 18 and 30 weeks (a total of~     four injections).~      All 140 study subjects will have a clinical and laboratory assessment at baseline, 18 weeks~     and at study end (40 weeks). All 140 subjects will also have imaging studies at baseline and~     at study end (40 weeks). The study protocol is outlined in more detail below:~      Clinical and laboratory assessment (Baseline and repeated 18 weeks, 40 weeks) A full medical~     history and physical examination will be performed. Symptoms will be assessed by the~     following standardised questionnaires: 1) Androgen Deficiency in the Aging Male (ADAM); 2)~     Aging Male Symptom scale (AMS); 3) International Index of Erectile Dysfunction (IIED); 4)~     International Prostate Symptom Score (IPSS); 5) SF-36 (all five questionnaires are attached~     to Module 1).~      Laboratory studies will consist of blood tests to measure total testosterone, fasting~     glucose, C-peptide, HBA1c and other routine parameters.~      Imaging studies (Baseline and repeated at 40 weeks)~        1. Body composition and bone mineral density by DEXA~        2. Body composition by magnetic resonance imaging~        3. Bony micro-architecture by high resolution quantitative computed tomography [HR-pQCT]),~        4. Cardiac dimensions and function by transthoracic doppler echocardiography~   "
224956|NCT00613769|"~     The current standard Swedish infection prophylaxis in colorectal surgery is intravenously~     administered cefuroxime and metronidazole. this combination is well studied. The~     disadvantages of the regimen is collateral damage resulting from treatment with a~     cephalosporine and that the combination also serves as the first line of treatment for~     abdominal surgical infections.~      Serval Swedish surgical departments have for some years used a combination of orally~     administered trimethoprim-sulfamethoxazole and metronidazole.~      The combination is economical and believed to be effective but hitherto the outcome have not~     been properly researched.~      The aim of this study is to compare the efficacy of these two regimens in the prevention of~     infection after elective colorectal surgery.~   "
224957|NCT00613756|"~     The survey is conducted to collect safety and effectiveness information targeting patients~     who have both Parkinson's disease and renal dysfunction treated with Pramipexole in the daily~     clinical settings in Japan.~   "
224958|NCT00613743|"~     Introduction:~      Oral pain due to mucosal lesion is quite frequent in oncology, geriatric as well as~     palliative care settings. The oncology patient is mainly suffering from radio- and/or~     chemotherapy induced oral mucositis. The incidence of oral mucositis in oncology patients~     ranges from 15-40% in those receiving stomatotoxic chemotherapy or radiotherapy. The degree~     of mucositis is variable, but the associated pain is frequent and well documented. Nowadays,~     basic oral care protocols are the mainstay of preventing or reducing mucositis pain. Pain is~     mainly managed by systemically administered analgesia. The only pioneer work in the field of~     radio-or chemotherapy induced mucositis treatment with topical opioids has been done by~     Cerchietti in two pilot studies: one compared magic mouthwash (lidocaine, diphenhydramine,~     magnesium aluminium hydroxide) with morphine mouthwash in a randomized trial; the other~     compared 1%o and 2% morphine solutions in an open trial. The results showed a significant~     decrease in the duration of pain, the intensity as well as a decrease the need for systemic~     analgesia in the group with morphine mouthwash. No systemic clinically relevant adverse~     effects were noted.~      Hypothesis:~      Mouthwashes with a morphine containing solution decrease oral pain substantially, while not~     causing the side effects seen in systemic administration of narcotic analgesics.~      Method:~      A randomised double-blind cross-over study to evaluate the effect of topical oral application~     of a 0.2% morphine solution in patients suffering from radio- and/or chemotherapy induced~     oral mucositis. 60 patients will be included. Randomly assigned to either the morphine~     solution or a placebo mouthwash, they receive the first three days one of the solutions and~     then are switched over to the other treatment for three more days. General basic oral care is~     offered to all of the patients. Efficacy of treatment will be measured with a self-assessment~     pain scale. Doses of systemic opioids and other symptoms (appetite, dysphagia) will also be~     measured. If patient's don't receive systemic opioids, serum concentrations of morphine will~     be measured.~   "
224959|NCT00613730|"~     This is a phase II, multi-center, open-label, single-arm clinical trial to be conducted in~     the United States. In approximately 55 centers, approximately 75 eligible locally advanced~     unresectable or metastatic pancreatic cancer subjects will be enrolled to receive first-line~     therapy of gemcitabine and panitumumab.~   "
224960|NCT00613717|"~     The Healthy Infant Development Project will determine if providing micronutrient supplements~     to mothers during pregnancy and infants in the first 9 months fosters healthy behavior and~     development in babies.~   "
224961|NCT00613691|"~     This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the~     Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD~     properties. Once the MTD for SPI-1620 is identified, a second phase of the study will focus~     on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study~     will assess the safety and tolerability of increasing doses of docetaxel administered with~     the optimal dose of SPI 1620 defined in Part I.~   "
224962|NCT00613678|"~     Purpose: To study the effects of two different rehabilitation programs for people with~     osteoarthritis of the hip or knee.~      Hypothesis 1: Participants who received Activity Stratgey Training will report less pain and~     physical disability at 8-weeks and 6-months follow-up.~      Hypothesis 2: Participants who receive Activity Strategy Training will have a greater~     increase in physical activity as measured by a wrist-worn accelerometer.~      Hypothesis 3: Participants who receive Activity Stratgey Training will report greater~     improvements in health-related quality of life.~   "
224963|NCT00613665|"~     This study was designed to investigate the safety and immunogenicity of Chiron's~     investigational H. pylori (HP3) vaccine~   "
224964|NCT00613652|"~     The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a~     weekly schedule in Japanese patients with advanced solid malignancies~   "
224965|NCT00613626|"~     At this point in the treatment of extensive stage SCLC, we have reached a plateau in survival~     with conventional chemotherapy and newer regimens are greatly needed. It has been noted that~     patients with increased VEGF levels have a poorer prognosis. Anti-angiogenic agents hold~     significant promise in the treatment of patients with extensive stage SCLC. ZD6474, a new~     inhibitor of the VEGFR-2, has shown favorable action in NSCLC.~   "
224966|NCT00613613|"~     The purpose of the study is to learn whether genetics plays a role in predicting response to~     a commonly used and FDA (Food and Drug Administration) approved medication for lowering~     triglycerides and cholesterol. Our hypothesis: The pharmacogenetics of genes which affect~     drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the~     body) influences how a person responds to the lipid lowering medication- fenofibrate.~   "
224984|NCT00613366|"~     The purpose of this study is to see if using misoprostol (a medication that softens the~     cervix) before placing an intrauterine device for contraception reduces pain in women who~     have never delivered a baby.~   "
224971|NCT00613548|"~     Background:~      The presence of a mild to moderate ischemic mitral regurgitation (IMR) results in a~     significantly reduced long-term survival and increased hospitalizations for heart-failure.~     The benefit of adding mitral valve surgery to coronary artery by-pass surgery (CABG) is well~     documented in the combination of coronary artery disease and severe MR. On the other hand, it~     is clinical practice to refrain from repairing the mitral valve in those CABG cases where the~     IMR is mild to moderate. However, there are no conclusive data available to support this~     principle. The existing studies are small, retrospective, and the results contradictive. The~     need for a prospective randomized trial has frequently been proposed and discussed, however,~     to the best of our knowledge, such a study has not yet commenced.~      Study design:~      The Moderate Mitral Regurgitation In Patients Undergoing CABG (MoMIC) Trial is the first~     international multi-center, large-scale study to clarify whether moderate IMR in CABG~     patients should be corrected. A total of 550 CABG patients with moderate IMR are to be~     randomized to either CABG alone or CABG plus mitral valve correction.~      Implication:~      If correction of moderate MR in CABG patients is the superior strategy, this should be~     offered to all patients in this entity.~   "
224972|NCT00613535|"~     The aim of this study is to describe changes at the site of the study patient's articular~     cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI)~     outcomes 6 months after treatment using one of three standard surgical treatment methods: 1)~     lavage debridement; 2) mechanical debridement; 3) mechanical and radiofrequency-based~     debridement.~   "
224973|NCT00613522|"~     Stroke is the third leading cause of death in industrialized countries and the first cause of~     handicap in adults. Several stroke risk factors were identified such as high blood pressure,~     diabetes mellitus, hypercholesterolemia or cardiac arrhythmias. Sleep respiratory disorders~     have been found to be frequent among patients with stroke. Among them obstructive sleep apnea~     (OSA) syndrome seems to be the most important due to its association with high blood pressure~     and atrial fibrillation.~      Stroke can be responsible of central apneas, therefore the differential diagnosis between~     central apneas and pure OSA after stroke is sometimes difficult. The misidentification of OSA~     can explain the poor tolerance of CPAP treatment by these patients. The purpose of the~     present study is to investigate the association between pre-stroke OSA syndrome OSA diagnosed~     on specific scales and confirmed by polygraphic studies and stroke occurrence.~   "
224974|NCT00613509|"~     Primary objective:~      To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free~     survival versus the clinical activity of the reference treatment.~      Secondary objectives:~      Safety: To describe the safety profile in both treatment groups.~      Efficacy: To determine the objective clinical responses of patients in both treatment groups:~     complete response and partial response.~   "
224975|NCT00613496|"~     Experimental data suggest that angiotensin II-antagonists reduce the atrial expression of~     prothrombotic adhesion molecules and oxidative stress parameters. The present study is~     designed to investigate the effects on angiotensin II-antagonist irbesartan to reduce the~     amounts of circulating oxidative stress markers and adhesion molecules in patients with~     persistent atrial fibrillation.~   "
224976|NCT00613470|"~     This study is one component of a larger U01 grant that was submitted in August, 2004 to the~     NIGMS as part of the Pharmacogenomic Research Network. This study will enroll 1200 patients~     over 4 years.~      It is known that functionally significant genetic polymorphisms for the cytochrome P450~     (CYPs) can contribute to individual differences in response to specific selective serotonin~     reuptake inhibitors (SSRIs). However, a better understanding of the pharmacogenomics of both~     PK and PD for SSRI antidepressants will inform clinical practice. Therefore, we propose to~     evaluate the contribution of pharmacogenomics to variation in response to the highly specific~     SSRIs citalopram (a racemic mixture) and escitalopram (a chiral compound containing the~     active S-isomer of citalopram ) by correlating both PK and PD variation for these agents with~     intragene haplotypes in genes encoding proteins involved in citalopram metabolism, as well as~     central nervous system (CNS) pathways for monoamine neurotransmitter biosynthesis,~     metabolism, storage, release, reuptake, and receptors. In the future this candidate pathway~     intragene haplotype genotyping strategy will also be complemented by the application of~     genome-wide screens performed with DNA from subjects with extreme phenotypes for response to~     citalopram.~      Phenotypes to be measured before and after the initiation of citalopram or escitalopram~     therapy will include determinations of serum citalopram and metabolite concentrations,~     treatment response as measured by Hamilton Rating Scale for Depression indices, and number~     and severity of side effects as determined by structured questionnaires. The hypothesis to be~     tested is that inherited variation in citalopram metabolism and transport (PK) and/or PD~     variation as a result of inherited variation in monoamine neurotransmitter biosynthesis,~     metabolism, reuptake, storage, receptors or signaling contribute to individual variation in~     citalopram antidepressant efficacy and/or side effects.~   "
224977|NCT00613457|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating young patients with acute~     lymphoblastic leukemia.~      PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens~     to compare how well they work in treating young patients with acute lymphoblastic leukemia.~   "
224978|NCT00613444|"~     The purpose of this research project is to study the effect of non-ablative (non-cutting)~     laser therapy, a technique that uses laser energy to try to improve the appearance of the~     skin. This type of laser treatment creates changes in a layer of the skin called the dermis~     without causing an open wound in the skin. The use of non-ablative laser therapy, together~     with application of a photo-sensitizer (substance that makes the skin more sensitive to~     light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it~     is supposed to make the laser more effective than using just the laser alone. It is not yet~     clear how much improvement can be seen with these treatments or exactly how the skin's~     response causes these improvements. In this study, we are interested in learning how well~     such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer~     actually enhances the efficacy of the laser.~      The photo-sensitizing agent (Levulan Kerastick) and the non-ablative laser (LumaCare LC-122M~     non-coherent (multiple wavelengths) light source from LumaCare® Medical Products) are both~     FDA-approved. The Levulan Kerastick is approved for the treatment of another skin disease,~     not acne.~   "
224979|NCT00613431|"~     The main purposes of this study are to assess the safety and measure the pharmacokinetics of~     CS-8080 in healthy volunteers.~   "
224980|NCT00613418|"~     This is a prospective, multicenter, non-randomized, single-arm trial; the primary objective~     is to assess the comparability of the performance of the IDev SUPERA® nitinol stent to a rate~     derived from a meta-analysis of studies on iliac stents approved by FDA for treating subjects~     with de novo or restenotic lesions in the common and/or external iliac arteries.~   "
224985|NCT00613353|"~     Objective activity data will be collected using accelerometry for a minimum of seven days on~     38 adult, female, women recruited from the metabolic Clinic at the University of Mississippi~     Medical Center. Following objective measurement of activity, participants will complete~     self-report and objective activity data, as well as the relationship between sedentary~     activities and food cravings will be examined. It is hypothesized that minutes of sedentary~     behavior, especially time spent in television viewing, will be significantly correlated with~     total and specific food cravings.~   "
224986|NCT00613340|"~     Cervical facet arthropathy is a common cause of chronic neck pain. The gold standard for~     diagnosis is either blocking the facet joints, or more commonly blocking the medial branch~     nerves that innervate the joints. However, many studies have found a high false-positive rate~     when the nerves are blocked using 0.5 ml of local anesthetic. We will randomize patients to~     receive either cervical facet medial branch blocks with 0.25 ml of local anesthetic and~     contrast, or 0.5 ml. We will then do a CT scan to determine the accuracy and specificity of~     each block. Our hypothesis is that using the higher volume (0.5 ml) might be responsible for~     the high false-positive rate.~   "
224987|NCT00613327|"~     The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic~     therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose~     escalation in participants with overactive bladder.~   "
224988|NCT00613314|"~     To determine the efficacy and safety of telmisartan-based treatment among patients with~     metabolic syndrome in actual setting in Philippines.~   "
224989|NCT00613301|"~     The survey is conducted to collect safety and effectiveness information in Parkinson's~     Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the~     daily clinical settings in Japan.~   "
224990|NCT00613288|"~     Testosterone(T) has known effects on many organ systems, although many of its metabolic~     actions are unrevealed. T is an anabolic hormone stimulating protein synthesis but this~     effect has barely been investigated in controlled studies. It also has lipolytic actions~     influencing body composition, but little is known of its regional impact on fat tissue. T~     affects insulin sensitivity. There is an increased incidence of hypogonadism in type 2~     diabetes, and among patients with hypogonadism there is an increased incidence of type 2~     diabetes. The actions of testosterone on glucose metabolism are unknown.~      The purpose of this study is therefore to:~      Investigate the lipolytic effect of testosterone on muscle and fat tissue. To gain insight in~     the intracellular mechanisms of testosterone on lipolysis and investigate possible regional~     differences in lipolysis and changes in body composition.~      Finally to investigate the effect of short term experimental hypogonadism and acute~     testosterone substitution on cytokines, insulin sensitivity and protein metabolism.~      The trial is a randomised double blinded cross-over study of 4 x 2 days with an interval of 1~     month in between. 12 healthy young men will receive GnRH treatment over a 3 month period and~     examined on 4 occasions with various degrees of T substitution and placebo . The examinations~     take place at the Research Lab within the Medical Department M.~      The investigations are deemed relevant to the understanding of the interrelationship between~     male hypogonadism and type 2 diabetes. The hypothesis is that T has beneficial effects on~     carbohydrate, fat and protein metabolism. The generated knowledge would therefore hopefully~     improve prophylaxis, screening and early treatment of both group of patients.~   "
224991|NCT00613275|"~     The Boston University Medical Center, funded by the National Cancer Institutes will train~     health workers at six of its affiliated Community Health Centers to guide patients through~     the cancer care system. The project will help to teach patients how to communicate more~     effectively with their health care team in order to understand the treatment options~     available to them. Although not widely available, it is believed patient navigation programs~     are beneficial.~      This research study will evaluate how well this tool works, especially among those who~     experience disparities in health care. The goal is to determine if having a trained navigator~     shortens the time between an abnormal test result and a definitive diagnosis and between a~     definitive diagnosis and completion of treatment for breast and Cervical cancer patients. The~     project also will evaluate whether navigation improves the ability to communicate with the~     doctor, satisfaction with patient's care and quality of life.~   "
224992|NCT00613262|"~     The investigators hypothesize that NBI will have a high accuracy in predicting polyp~     histology real time during a colonoscopy by visualization of the surface mucosal and vascular~     patterns. Aim#1: To determine the sensitivity, specificity and accuracy of NBI and standard~     white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and~     vascular patterns during colonoscopy. Aim#2: To determine the inter-observer agreement~     between investigators for the recognition of various polyp patterns.~   "
224993|NCT00613249|"~     IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one~     research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age,~     randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the~     pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or~     Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day~     washout period and then 10 consecutive days); and to assess the safety of these gels as~     compared to the intravaginal HEC-based universal placebo gel.~   "
224994|NCT00613223|"~     Primary Objective: To determine maximum tolerated dose & dose limiting toxicity of vandetanib~     when combined with standard dosing of etoposide among patients with recurrent malignant~     glioma who are on & not on enzyme-inducing anti-epileptic drugs (EIAEDs) Secondary~     Objectives: To assess safety & tolerability of vandetanib + etoposide in this population; To~     evaluate pharmacokinetics of vandetanib among malignant glioma patients on & not on EIAEDs~     when combined with etoposide.~      Exploratory Objective: To evaluate for evidence of anti-tumor activity of study regimen among~     recurrent malignant glioma patients including radiographic response rate, 6-month progression~     free survival (PFS) rate & median PFS.~   "
224995|NCT00613210|"~     to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and~     abnormal doppler of the uterin artery can predict preterm labor~   "
225029|NCT00612768|"~     Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP)~     formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.~   "
244556|NCT00352963|"~     This study will evaluate the immunogenicity of the co-administration of different~     combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.~   "
224996|NCT00613197|"~     The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin~     Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease~     Activity Index CDAI < 150) in CD patients in whom remission, stable for at least three months~     and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP,~     methotrexate, 5-ASA or antibiotics.~      Secondary objectives are to assess the:~      efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and~     Subject Global Ratings, employment status and use of CD related medical visits in subjects~     with CD in remission~      safety and tolerability of Epanova~      ability of Epanova to maintain the quality of life of CD patients in remission~   "
224997|NCT00613184|"~     Collection of nasal secretions from infants and toddlers for viral testing is usually done~     using the nasal washing technique described by Hall in 1975. This is cumbersome. Previous~     attempts to use swabs have been unsuccessful because the swabs didn't work well. A newly~     designed swab may work better and in this study we compare the new swab with the old style~     nasal washing.~   "
224998|NCT00613171|"~     This study will investigate the efficacy and safety of STI571 for the treatment of fibrosis~     in patients with systemic sclerosis. Other purposes of the study are to investigate whether~     STI571 is effective in improving lung functions and other test results called biomarkers.~     Whether STI571 is well-absorbed in systemic sclerosis patients' gut will also be investigated~     by testing the drug level in the blood (pharmacokinetics).~   "
224999|NCT00613158|"~     Cardiovascular disease (CVD), including heart disease, heart attack, high blood pressure, and~     stroke, is most commonly caused by atherosclerosis, or a hardening of the arteries.~     Traditional risk factors for CVD include age, high blood pressure, high cholesterol,~     diabetes, and smoking. Although these established risk factors can be helpful in determining~     people at risk for developing CVD, the addition of novel gene markers for subclinical, or~     suspected, atherosclerosis (SA) may enhance CVD risk prediction and understanding of disease~     mechanisms. This study will compare specific genes of white blood cells in people with~     significant SA versus people without SA to improve identification of those at risk for~     developing CVD and to better understand the biological basis of SA.~   "
225000|NCT00613145|"~     This is a phase I, randomized, safety and pharmacokinetic (PK) study of sorafenib given in~     combination with capecitabine. The study will enroll two simultaneous cohorts; patients will~     be randomly assigned to either Cohort A or Cohort B. A third cohort (C) may be added to the~     protocol at a later date.~   "
225001|NCT00613132|"~     Primary objective To determine maximum tolerated dose & dose limiting toxicity of imatinib~     mesylate & RAD001 when combined w fixed doses of hydroxyurea among pts w recurrent GBM who~     are on & not on enzyme-inducing anti-convulsants including pts not on anti-epileptic drugs~     Secondary objective To assess safety & tolerability of imatinib mesylate in combo w RAD001 &~     hydroxyurea in this population To characterize single-dose & repeated-dose pharmacokinetic~     profiles of imatinib mesylate & RAD001 combo therapy in this pt population.~      To assess antiangiogenic effects, pre- and post-treatment, of imatinib mesylate, RAD001 &~     hydroxyurea combo therapy, using DCE-MRI to evaluate changes in extent of vascular~     permeability, perfusion & relative tumor blood volume; to explore assessment of tumor~     cellularity & tumor cell death by changes in DWI-MRI as quantitated by apparent diffusion~     coefficient maps.~   "
225002|NCT00613119|"~     This study will use positron emission tomography (PET) imaging to measure a receptor in the~     brain that is involved in inflammation. Certain neurological disorders, possibly including~     frontotemporal dementia (FTD), are associated with increased inflammation in the brain. This~     study may help elucidate the relationship between FTD and inflammation.~      Patients with FTD and healthy volunteers who are 35 years of age or older may be eligible for~     this study. Candidates are screened with a medical history, physical examination,~     electrocardiogram, and blood and urine tests.~      Participants undergo the following procedures:~        -  Whole body PET scan: PET uses small amounts of a radioactive chemical called a tracer~          that labels active areas of the brain so the activity can be seen with a special camera.~          The tracer used in this study is [11C]PBR28. Before starting the scan, a catheter~          (plastic tube) is placed in a vein in the arm to inject the tracer. Pictures are taken~          for 1 hour. This short scan is done to determine if [11C]PBR28 binds to the subject s~          receptors, since a number of people do not have binding. Subjects who have binding~          continue with brain PET and MRI scans, described below.~        -  Brain PET imaging: Before starting the scan, a catheter is placed in a vein in the arm~          to inject the tracer,<TAB> and another catheter is placed in an artery in the wrist to~          obtain blood samples during the scan. The subject lies on the scanner bed. A special~          mask is fitted to the head and attached to the bed to help keep the person s head still~          during the scan so the images will be clear. An 8-minute transmission scan is done just~          before the tracer is injected to provide measures of the brain that are helpful in~          calculating information from subsequent scans. After the tracer is injected, pictures~          are taken for about 2.5 hours, while the subject lies still on the scanner bed.~        -  Blood and urine tests are done the day of and the day following each PET scan.~        -  Magnetic resonance imaging (MRI): An MRI scan is done within 1 year (before or after) of~          the PET scan. This procedure uses a magnetic field and radio waves to produce images of~          the brain. The subject lies on a table that is moved into the scanner (a tube-like~          device), wearing earplugs to muffle the noise of the machine during the scanning~          process. The test takes about 1 hour.~   "
225003|NCT00613106|"~     The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.~   "
225004|NCT00613093|"~     Objectives:~      To define role of O6-Benzylguanine (BG) in restoring Temodar (temozolomide) sensitivity in~     patients with Temodar-resistant malignant glioma.~      To further define toxicity of combo therapy using Temodar + BG.~   "
225005|NCT00613080|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Specialized radiation~     therapy that delivers a high dose of radiation directly to the tumor may kill more tumor~     cells and cause less damage to normal tissue. Giving these treatments before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving~     chemotherapy after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects and how well giving combination~     chemotherapy together with intensity-modulated radiation therapy works in treating patients~     undergoing surgery for locally advanced rectal cancer.~   "
225032|NCT00612729|"~     Visible-light-filtering IOLs are implanted increasingly often in cataract surgery. Several~     studies examined the effect of light-filters on contrast and colour vision. However, the~     study outcomes were varying. The present study investigated the effect of two light-filtering~     IOL on colour perception and contrast acuity using highly sensitive measurement methods.~   "
225047|NCT00612534|"~     The purpose of this study is to evaluate three different dosage strengths of sublingual~     ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of~     post-operative pain in subjects following total knee replacement surgery. We hypothesize that~     subjects receiving placebo will have poor pain relief and will drop out of the study sooner~     and more often than the ARX-F01-treated subjects.~   "
225006|NCT00613067|"~     Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone~     intensities have been suggested as a correlative of central serotonergic activity. A strong~     loudness dependence amplitude increase (strong intensity dependence) reflects low~     serotonergic neurotransmission and vice versa. Many researchers assumed that the brain~     serotonergic activity could influence treatment response of highly selective serotonin~     reuptake inhibitors in depression and anxiety disorders. There are a couple of studies~     reporting associations of N1 amplitude intensity dependence with response to Citalopram~     (positive correlation) and Reboxetine (negative correlation) treatment in major depressive~     disorder patients. But so far there have been no reports about associations between ERP N1~     and antidepressant response in GAD patients.~      So, it would be very interesting to explore the correlations between ERP N1 amplitude change~     and the Escitalopram treatment responsiveness in GAD patients.~   "
225007|NCT00613054|"~     Primary Objective To determine maximum tolerated dose & dose limiting toxicity of Zactima~     when combined w standard dosing of imatinib mesylate & hydroxyurea among pts w recurrent~     malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary~     Objectives To assess safety & tolerability of Zactima + imatinib mesylate & hydroxyurea To~     evaluate pharmacokinetics of Zactima among MG pts on & not on enzyme inducing anti-epileptic~     drugs (EIAEDs) when combo w imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of~     imatinib mesylate among MG pts on & not on EIAEDs when combo w Zactima & hydroxyurea~     Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among~     recurrent malignant glioma (RMG) pts including radiographic response rate, 6-month~     progression free survival (PFS) rate & median PFS~   "
225008|NCT00613041|"~     In recent years, more and more people are having lung CT scans performed to screen for~     various cancers. Many of them have small abnormalities detected, called nodules, which -~     for a variety of reasons - doctors are unable to biopsy. As a result, many patients have~     their CT scans repeated on a regular basis to see if their nodules grow. This process can~     last several years.~      Many patients experience significant anxiety during this process, when they are aware of a~     spot in the lung, but are not told any specific cause.~      Researchers at Memorial Sloan-Kettering have developed a new way to look at lung nodules in~     three dimensions. The purpose of this project is to see if any change in the nodules can be~     detected sooner by this method than by traditional CT scans.~   "
225009|NCT00613028|"~     Primary objective To estimate 6-month progression free survival probability of pts w~     recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on~     bev + irinotecan Secondary Objectives To evaluate safety & tolerability of bev + either daily~     temozolomide/etoposide among pts w recurrent GBM who have progressed on bev + irinotecan To~     evaluate radiographic response, progression free survival & overall survival of pts w~     recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on~     bev + irinotecan~   "
225010|NCT00613015|"~     Stressful situations and cues associated with cocaine can lead to craving in cocaine~     dependent individuals. The purpose of this study is to determine whether guanfacine or~     modafinil are effective in reducing stress and cue induced craving in cocaine dependent~     individuals.~   "
225011|NCT00613002|"~     This study is a randomized, double-blind, placebo-controlled, multi-center study of the~     safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal~     women~   "
225012|NCT00612989|"~     Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine~     administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize~     toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w~     progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar®~     in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment~     cycle between days 7 & 14 in pts w progressive/recurrent GBM To obtain preliminary response~     rates of Temodar® in combo w O6-BG administered for 5 consecutive days in pts w~     progressive/recurrent GBM~   "
225013|NCT00612976|"~     Under daily routine conditions and without any intervention by the sponsor regarding the~     selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non-~     medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians~     (i.e.general practitioners and internists) are asked to document relevant data related to the~     budesonide/formoterole therapy in patients with COPD.~   "
225014|NCT00612963|"~     The purpose of the study is to evaluate the efficacy of Iocide oral rinse as a treatment for~     Oral Candidiasis in any patient including but not limited to patients receiving radiation~     therapy or who have previously received radiation therapy for head and neck cancer, or~     patients positive for HIV/AIDS or are transplant patients.~   "
225015|NCT00612950|"~     The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to~     impaired potentiation of beta-cell responsiveness to glucose by glucose dependent~     insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present~     study was to investigate whether 4 weeks of near-normalization of blood glucose could improve~     the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.~   "
225030|NCT00612755|"~     A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with~     peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on~     Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions~     and the viral clearance was larger than mono-infected patients.~      The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus~     mono-infected is related with the loss of profited on treatment.~      In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates~     was only 2%.~      The present study want to evaluate is the treatment extent for 24 weeks more in patients~     genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the~     end of the follow-up period, to prevent relapsed in patients with response at the end of~     treatment.~      Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200~     mg/day of ribavirin during 24 weeks more or control.~   "
225031|NCT00612742|"~     This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center~     study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD~     in postmenopausal women with at least two points of cardiovascular risk and clinical~     diagnosis of Hypoactive Sexual Desire Disorder (HSDD).~   "
225016|NCT00612937|"~     This study will evaluate whether babies are more at risk of developing breathing problems if~     their mothers carry group B streptococci (GBS) in vagina/rectum, and whether the breathing~     problem is due to phospholipids released by the GBS. About one in five pregnant women carry~     GBS in their vagina/rectum. Mothers who carry these bacteria are given antibiotics during~     labor to prevent infection in the baby. However, recently it has been suspected that even~     without blood stream infection, the chemicals released by GBS, called phospholipids, might~     lead to breathing problems.~      Women at 32 or more weeks of pregnancy who deliver at Ben Taub Hospital and St. Luke s~     Episcopal Hospital in Houston, Texas, and Alta Bates Summit Medical Center in Oakland,~     California, may be eligible for this study.~      Mothers undergo the following procedures:~        -  Vaginal/rectal GBS culture. A sample is collected from the lower vagina and rectum using~          a cotton swab upon admission to labor and delivery.~        -  Blood collection to test for phospholipids. A blood sample is obtained from the mothers~          at the time of routine blood drawing during labor, and a blood sample is obtained from~          the umbilical cord (after delivery).~        -  Collection of health information from the medical record.~      Newborns undergo the following procedures:~        -  GBS culture. Samples are collected from cotton swabs of the ears, navel, anus and throat~          to test for GBS bacteria.~        -  A small amount of blood from newborns is obtained for phospholipids test when the~          newborns have blood drawn for other tests.~        -  Collection of health information from the medical record.~   "
225017|NCT00612924|"~     The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase~     II. The primary objectives of the Phase II study is to assess the safety and effectiveness of~     the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA).~     The secondary objectives of this study are to assess additional clinical outcomes~     measurements associated with treatment of AAA using the Anaconda Stent Graft System~   "
225018|NCT00612911|"~     Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy~   "
225019|NCT00612898|"~     Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often~     included as part of patients' treatment, but many HIV-infected patients develop resistance to~     commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine~     whether including apricitabine as part of patients' treatment is more effective than~     including lamivudine,when patients change treatment because of drug resistance.~   "
225020|NCT00612885|"~     The main objective of this PMS study was to monitor and assess the safety of Mobic®~     intramuscular injection (7.5mg ~ 15mg, q.d.) up to 3 days (in case of need for prolonged~     treatment, switch to Mobic® capsule therapy was possible) in Korean patients with~     osteoarthritis and rheumatoid arthritis.~   "
225021|NCT00612872|"~     To assess the dynamic uptake and washout of 123-I CLINDE, a potential imaging biomarker for~     inflammatory changes in brain, using single photon emission computed tomography (SPECT) in~     similarly aged healthy controls and subjects with Alzheimer (AD) or Parkinson disease (PD).~      To perform blood metabolite characterization of 123-I CLINDE in healthy and subjects with AD~     or PD to determine the nature of metabolites in assessment of 123-I CLINDE as a single photon~     computed tomography (SPECT) brain imaging agent.~      Evaluate the test/retest reproducibility of 123-I CLINDE, and SPECT in AD and PD subjects and~     healthy controls~   "
225022|NCT00612859|"~     Preclinical and clinical findings indicate that LEV has some anxiolytic potential. There is~     reason to believe that compounds with anxiolytic activity may have broad clinical utility~     across the anxiety spectrum. This trial was intended to explore LEV's utility in adults with~     social anxiety disorder.~   "
225023|NCT00612846|"~     The aim of the trial is to compare two operations which are used to treat bile duct stones.~     The hypothesis of the study is that there is no difference between endoscopic sphincterotomy~     followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during~     laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.~   "
225024|NCT00612833|"~     This study will be a randomized, controlled multicenter trial, conducted jointly by the~     Indian Council of Medical Research, New Delhi and Family Health International, which will~     compare three vasectomy occlusion techniques, all using the no-scalpel vasectomy (NSV)~     approach to isolation of the vas:~        1. ligation and excision of about 1 cm of the vas, with fascial interposition;~        2. intraluminal thermal cautery with excision of about 1 cm of the vas;~        3. intraluminal thermal cautery with excision of about 1 cm of the vas combined with~          fascial interposition.~      A total of 1500 healthy, sexually active men at least 21 years old who have chosen vasectomy~     as a means of contraception will be recruited at four to six study sites in India. The~     success of the vasectomy procedure will be determined based on semen analysis results. All~     men should have semen analyses at 8 and 12 weeks post-vasectomy. All men will be asked to~     attend a final visit at 12 months.~   "
225025|NCT00612820|"~     This is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of~     intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects~     with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for~     enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety~     assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will~     be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape~     and allergen challenge assessments will also be performed at various time points throughout~     the study.~   "
225026|NCT00612807|"~     The primary goal of this study is to develop and test a depression-specific marital therapy~     tailored for use with older adult populations.~   "
225027|NCT00612794|"~     Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly~     version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide~     once weekly in Japanese patients. This study is designed to evaluate safety and tolerability~     of exenatide once weekly in Japanese patients and determine whether the dose selected for US~     and European development is appropriate for Japanese patients with Type 2 diabetes.~   "
225028|NCT00612781|"~     Blue-light-filtering IOLs are implanted increasingly often in cataract surgery. Several~     studies examined the effect of blue-light-filters on contrast and colour vision. However, the~     study outcomes were varying. The present study investigated the effect of a~     blue-light-filtering IOL on colour perception and contrast acuity using highly sensitive~     measurement methods.~   "
225033|NCT00612716|"~     RATIONALE: Giving chemotherapy, such as cyclophosphamide and busulfan, and total-body~     irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It~     also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells from bone marrow or umbilical cord blood may replace the patient's immune cells~     and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving methotrexate and cyclosporine after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in~     treating patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic~     leukemia.~   "
225034|NCT00612703|"~     To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when~     administered in combination with erlotinib to patients with advanced solid tumors~   "
225035|NCT00612690|"~     This study will evaluate the effectiveness of school- and home-based mental health services~     and training modules in supporting learning and behavior in financially disadvantaged~     children who live in urban areas.~   "
225036|NCT00612677|"~     The purpose of this study is:~        -  To find out if the chemotherapy treatment using Pemetrexed (Alimta) and Oxaliplatin~          (Eloxatin) given together will kill the cancer cells in the patient's body and shrink~          the size of their tumor. This may allow patients to live longer or decrease the~          frequency and/or severity of the symptoms caused by the cancer. Pemetrexed has been~          approved by the Food and Drug Administration (FDA) to treat Lung Cancer. Oxaliplatin has~          been approved by the FDA for the treatment of Colon Cancer. The combination of these two~          drugs has been used to treat patients with Non-Small Cell Lung Cancer in Italy but not~          yet in the USA~      Other purposes of this study are:~        -  To better detail the toxic effects of this chemotherapy combination.~        -  To determine whether the level of specific gene and/or gene products (genes are genetic~          material that allows cells to make proteins such as enzymes) are useful to predict if~          this chemotherapy combination will work or not.~   "
225037|NCT00612664|"~     The main purpose of this study is to estimate the proportion of patients with a type of skin~     cancer called melanoma who are progression free, (that is, the cancer has not gotten~     substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg~     or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks~   "
225038|NCT00612651|"~     Objectives:~      To determine maximum tolerated dose of farnesyl transferase inhibitor, SCH 66336, when~     administered w TEMODAR®.~      To characterize any toxicity associated w combo of farnesyl transferase inhibitor, SCH 66336,~     & TEMODAR®.~      To observe patients for clinical antitumor response when treated with combination of farnesyl~     transferase inhibitor, SCH 66336, & TEMODAR®.~      To assess pharmacokinetics of SCH 66336 for patients on & not on enzyme inducing~     antiepileptic drugs.~   "
225039|NCT00612638|"~     Objectives:~      To determine maximum tolerated dose of CPT-11 when administered following Temodar plus~     O6-benzylguanine To characterize any toxicity associated w combo of CPT-11 + Temodar plus~     O6-BG To observe pts for clinical antitumor response when treated w combo of CPT-11 + Temodar~     + O6-BG~   "
225040|NCT00612625|"~     The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is~     impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We~     investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation~     of glucose-stimulated insulin secretion by GLP-1~   "
225041|NCT00612612|"~     Obatoclax may stop the growth of chronic lymphocytic leukemia by blocking blood flow to the~     cancer and by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells~     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Giving obatoclax together with fludarabine and rituximab may kill more~     cancer cells. This phase I trial is studying the side effects and best dose of obatoclax when~     given together with fludarabine and rituximab in treating patients with B-cell chronic~     lymphocytic leukemia.~   "
225042|NCT00612599|"~     This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics~     and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin~     aspart 70 three times a day in non-obese and obese with type 2 diabetes.~   "
225043|NCT00612586|"~     This study will evaluate the addition of enzastaurin to 5-FU(5-fluorouracil)/LV (leucovorin)~     plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line~     therapy consisting of FOLFOX (5-FU/LV + oxaliplatin) or FOLFIRI(5-FU/LV + irinotecan), plus~     bevacizumab in patients with Metastatic Colorectal Cancer.~   "
225044|NCT00612573|"~     Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety~     and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the~     Investigator's Global Assessment (IGA) score and the absolute change from baseline in~     inflammatory lesion count in patients with moderate to severe facial acne vulgaris.~     Additionally, the absolute change from baseline in non-inflammatory and total lesions of the~     active study medication to placebo will be evaluated.~   "
225045|NCT00612560|"~     The proposed study plans to examine the effect of flaxseed consumption, a phytoestrogen rich~     food, compared to aromatase inhibitors as a complementary approach to treating estrogen~     receptor positive breast cancer, as well as the effect of combined flaxseed and aromatase~     inhibitor therapy on breast cancer treatment. Because of the increasing use of both~     complementary and alternative approaches to treatment, and the use of aromatase inhibitors in~     the treatment of breast cancer, the proposed study has potential to provide important~     clinical information about the effect of foods high in phytoestrogens on a common endocrine~     therapy used in breast cancer.~   "
225046|NCT00612547|"~     The purpose of this study is to assess the feasibility, the acceptability and the~     effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home~     management of presumed malaria in Malagasy children by the community-based service providers.~   "
225062|NCT00612339|"~     Primary objective- To determine efficacy of Avastin, 10 mg/kg every other week, in~     combination with standard 5-day temozolomide in terms of response rate.~      Secondary objective- To determine safety of Avastin & Temozolomide in unresectable~     glioblastoma patients~   "
225048|NCT00612521|"~     Myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after~     coronary artery stenting. Such events have been associated with poor outcomes both at 30 days~     and long term. The cause of such damage is multi-factorial and includes distal propagation of~     atheromatous and thrombotic debris and the subsequent infiltration of the microcirculation~     with inflammatory cells. Individually or together these events can occlude the~     micro-circulation and lead impaired blood flow to heart muscle.~      The vasodilator adenosine is commonly used in cases of impaired flow in an endeavor to~     improve flow rate and limit myocardial damage. Unfortunately the efficacy of this therapy is~     limited. More recently, there have been clinical studies looking at the administration of~     adenosine before any potential damage by ballooning or stenting, in an effort to avoid poor~     distal flow post procedure and thus limit any myocardial damage. Although small numbers of~     subjects have been included in these trials, there have been encouraging preliminary data.~      The aim of this study is to assess whether the use of intra-coronary adenosine given directly~     into the target coronary artery prior to stenting can reduce the incidence of myonecrosis~     (heart muscle damage)over placebo. We also aim to assess whether this translates to better~     outcomes at 30 day follow up.~   "
225049|NCT00612508|"~     The purpose of this study is to help determine if the route by which women receive hormonal~     contraception causes different changes to occur in the lining of the vagina. The~     investigators plan to compare an oral route (taking birth control pills) with a vaginal route~     (using a vaginal ring).~   "
225050|NCT00612495|"~     To determine the efficacy (response rate [RR], time to progression and survival) of~     oxaliplatin as a single agent and oxaliplatin in combination with 5 FU in patients with~     advanced/metastatic endometrial cancer pretreated with one prior chemotherapy regimen~     containing cisplatin (CDDP) or carboplatin and to define the safety profile of each arm of~     the above mentioned regimens in these patients~   "
225051|NCT00612482|"~     Our primary goal is to conduct a pilot study of the effects of a new potential strategy for~     youth substance abuse prevention - science-based drug education integrated into the high~     school science curriculum. Through this pilot study we propose to: (1) demonstrate that this~     new strategy shows promise, and (2) estimate the effect size for the intervention.~   "
225052|NCT00612469|"~     The aim of the present study was to compare salivary MS levels in four different groups of~     children with caries, that have been submitted to intraoral topical treatment with either~     1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days.~     This clinical trial was designed to test two different hypotheses. First, that topical~     vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS~     reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would~     produce a long lasting MS suppression, dispensing repeated antibacterial treatments.~   "
225053|NCT00612456|"~     This is a 28 day study to evaluate the pharmacodynamic effect of pazopanib eye drops on the~     central retinal thickness of AMD patients~   "
225054|NCT00612443|"~     The purpose of this study is to evaluate the effectiveness of Healing Touch to improve~     health-related quality of life in women with breast cancer receiving radiation therapy.~      Research Hypothesis Healing Touch significantly improves health-related quality of life when~     compared to a placebo treatment, among women receiving radiation therapy for treatment of~     breast cancer.~   "
225055|NCT00612430|"~     Primary Objective to estimate 6-month progression free survival probability of patients with~     recurrent malignant glioma treated with Etoposide + Bevacizumab.~      Secondary Objectives To evaluate safety & tolerability of Etoposide + Bevacizumab among~     patients with recurrent malignant glioma (RMG).~      To evaluate radiographic response, progression free survival & overall survival of patients~     with recurrent malignant glioma treated with Etoposide + Bevacizumab.~   "
225056|NCT00612417|"~     Single administration of recombinant FVIII/placebo in healthy male subjects who have been~     treated with a single dose of anti-factor VIII antibody, TB-402~   "
225057|NCT00612404|"~     Under daily routine conditions and without any intervention by the sponsor regarding the~     selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non-~     medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians~     (i.e. gastroenterologists) are asked to document relevant data in patients with~     gastrointestinal disorders.~   "
225058|NCT00612391|"~     A prospective randomized clinical trial is proposed to compare the plate fixation of proximal~     humerus fractures using a minimally invasive lateral approach and the traditional anterior~     approach.Forty five patients will be assigned to each approach (total of 90 patients) and~     will be assessed 7 times over a two-year period. The trial's primary objectives will be to~     demonstrate the efficacy of the plating technique in terms of speed of recuperation of~     function. The Quick DASH will be used for evaluation of function.The study will also examine~     secondary end-points of pain, range of motion, esthetic satisfaction and radiographic~     outcome, as assessed by the components of the Constant Score3,4, SF-12V2 Questionnaire, and~     Patient Scare Assessment Scale Questionnaire. Furthermore, the assessment of safety will be~     based on the rates of all reported complications and adverse events at 2 years~   "
225059|NCT00612378|"~     The purpose of this research study is to evaluate the immediate effectiveness of the GFX™~     device in reducing the furrows (deep frown lines) between eyebrows (glabellar region).~   "
225060|NCT00612365|"~     Obesity is a growing public health concern, with approximately 31% of Americans considered~     obese. The link between abdominal obesity and cardiovascular disease (CVD) has been well~     established, but the effect of distinct types of abdominal fat tissue on CVD risk is not well~     known. The rate of obesity and the distribution of abdominal fat differ with age, sex, and~     ethnicity. These differences may have important implications for determining ethnic-specific~     relationships between abdominal body composition (ABC), inflammation, and CVD events. This~     study will evaluate the association between measures of abdominal fat, CVD risk, and~     inflammation in terms of ethnicity-, sex-, and age-specific differences.~   "
225061|NCT00612352|"~     The proposed study is the first to explore the contribution of brain glutamate systems, a~     major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study~     may lead to an enhanced understanding of the underlying neurobiological mechanism in high~     risk individuals that may lead to the transition from moderate to excessive use of alcohol.~   "
244557|NCT00352950|"~     To determine the dose and schedule of sirolimus when given in combination with panitumumab in~     adult subjects with Stage IIIB/IV NSCLC~   "
225063|NCT00612326|"~     The purpose of this study is to to find out if the MRI and PET scans can truly stage patients~     with bladder cancer. Both scans use newer ways to find out if your disease has grown beyond~     the bladder. The radioactive tracer used for the PET scan is called C-11 Acetate. We want to~     see if PET scan will be able to take a picture of the inside of your body that is better than~     other scans such as the CT scan and MRI. Therefore, the findings of the PET scan will be~     compared with other imaging studies as well as the surgical findings.~   "
225064|NCT00612313|"~     This study will compare the effectiveness of fluoxetine alone with the effectiveness of~     fluoxetine with cognitive behavioral therapy in increasing recovery and preventing relapse in~     youth with major depressive disorder.~   "
225065|NCT00612300|"~     The objective of this study is to investigate the effects of an automatic gait trainer~     (Lokomat) handled by physical therapists compared with categorized gait training by physical~     therapists in ambulatory stroke patients. Gait speed, gait distance and gait symmetry are~     used to evaluate study effects.~      Hypotheses: 1) The Lokomat improves stroke patients gait speed, distance and symmetry more~     than categorized gait training.~   "
225066|NCT00612287|"~     The purpose of this study is to develop and pilot test clinical guidelines for the use of~     buprenorphine for the treatment chronic pain among patients with substance abuse histories.~     Buprenorphine, an opioid medication, holds promise as a treatment of chronic pain because,~     compared to most other opioid analgesics, it has a high safety profile, a low level of~     physical dependence, and mild withdrawal symptoms on cessation. Moreover there are promising~     reports from Europe of its use as a skin patch to treat chronic pain as well as clinical~     reports in the U.S. that it may be effective when used sublingually (placed under the~     tongue). This study will test the sublingual formulation.~   "
225067|NCT00612274|"~     The primary objective of this trial is to study the safety and efficacy of a novel regimen of~     sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease~     (GVHD) in recipients of mismatched unrelated donor stem cell grafts. Methotrexate is~     administered in a low dose format of 5mg/m2 on days +1,3 and 6 only.~   "
225068|NCT00612261|"~     Branch retinal vein occlusion (BRVO) is a common retinal vascular disease occurring in a~     significant number of individuals older than 50 years.The most common cause of visual~     disturbance in BRVO patients is macular edema, which has been reported in 60% of patients.~     Macular grid laser photocoagulation has been shown to be effective in the treatment of~     macular edema arising from BRVO. Some eyes are resistant to conventional grid laser~     treatment, and the conventional treatment is not useful in patients with intraretinal~     hemorrhages that may interfere with laser photocoagulation. Moreover, several studies have~     shown that conventional grid laser treatment for macular edema may be associated with~     complications.~      Intravitreal triamcinolone acetonide (IVTA) injection has recently been reported to be~     effective in the treatment of macular edema of various etiologies.On the other hand,~     arteriovenous sheathotomy is a surgical method suggested for treatment of macular edema in~     BRVO patients, and has been reported to be efficacious in patients refractory to conventional~     focal or grid laser macular photocoagulation.Both treatment modalities have been reported to~     be associated with reductions in central macular thicknesses and improved visual acuities.~      The purpose of the study is to compare the efficacies of arteriovenous (AV) sheathotomy and~     intravitreal triamcinolone (IVTA) injection in the treatment of macular edema associated with~     branch retinal vein occlusion (BRVO).~   "
225069|NCT00612248|"~     Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the~     effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand.~   "
225070|NCT00612235|"~     This study is being done to determine if there are differences in mood during the menstrual~     cycle among women with epilepsy who take various different antiepileptic drugs and women~     without epilepsy.~   "
225071|NCT00612222|"~     Background:~        -  Melanoma antigen recognized by T-cells (MART)-1 is a protein present in melanoma cells.~        -  An experimental procedure developed for treating patients with melanoma uses the~          anti-MART-1 F5 gene and a type of virus to make special cells called anti-MART-1 F5~          cells that are designed to destroy the patient's tumor. These cells are created in the~          laboratory using the patient's own tumor cells or blood cells.~        -  The treatment procedure also uses a vaccine called plaque purified canarypox vector~          (ALVAC) MART-1, made from a virus that ordinarily infects canaries and is modified to~          carry a copy of the MART-1 gene. The virus cannot reproduce in mammals, so it cannot~          cause disease in humans. When the vaccine is injected into a patient, it stimulates~          cells in the immune system that may increase the efficiency of the anti-MART-1 F5 cells.~      Objectives:~      -To evaluate the safety and effectiveness of anti-MART-1 F5 and the ALVAC vaccine in treating~     patients with advanced melanoma.~      Eligibility:~      -Patients 18 years of age with metastatic melanoma for whom standard treatments have not been~     effective.~      Design:~        -  Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells~          for laboratory treatment.~        -  Patients have 7 days of chemotherapy to prepare the immune system for receiving the~          anti-MART-1 F5.~        -  Patients receive the ALVAC vaccine, anti-MART-1 F5 cells and interleukin-2 (IL-2) (an~          approved treatment for advanced melanoma). The anti-MART-1 F5 cells are given as an~          infusion through a vein. The vaccine is given as injections just before the infusion of~          anti-MART-1 F5 cells and again 2 weeks later. IL-2 is given as a 15-minute infusion~          every 8 hours for up to 5 days after the cell infusion for a maximum of 15 doses.~        -  After hospital discharge, patients return to the clinic for periodic follow-up with a~          physical examination, review of treatment side effects, laboratory tests and scans every~          1 to 6 months.~   "
225072|NCT00612209|"~     This is an open label, single arm, dose escalation study of ARQ 197 in patients with advanced~     solid tumors.~   "
225073|NCT00612196|"~     Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody~     directed against FVIII, versus placebo in healthy male volunteers.~   "
225074|NCT00612183|"~     The purpose of this study is to assess the antitumor effects and safety of bendamustine~     hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle~     cell lymphoma.~   "
225075|NCT00612170|"~     This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving~     the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful~     treatment effects in fibromyalgia, based on pain and functional endpoints.~   "
225076|NCT00612157|"~     The purpose of this study is to assess the efficacy of Eszopiclone in improving short and~     intermediate-term compliance with continuous positive airway pressure (CPAP) in patients~     newly diagnosed with obstructive sleep apnea (OSA).~   "
225077|NCT00612144|"~     The aim of this study is to compare the efficacy and safety of early combination therapy with~     Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM~     inadequately controlled by prior monotherapy with metformin.~   "
225098|NCT00611871|"~     The purpose of this investigation is to see if propranolol will reduce the~     psychophysiological hyperactivation associated with memories of combat stress in Veterans~     with Posttraumatic Stress Disorder.~   "
225078|NCT00612131|"~     I Hypothesis:~        1. Simulation-based training in maximal barrier precaution technique during central venous~          catheter (CVC) placement is superior to general videotape-based training~        2. Baseline performance in maximal barrier precaution technique of PGY 2 and 3 Medical~          residents, certified in CVC placement, is poor~        3. PGY 2 and 3 medical residents have low self-perceived confidence in mastering maximal~          barrier precaution technique during central venous catheter (CVC) placement~        4. PGY 2 and 3 medical residents undergoing simulation-based training in maximal barrier~          precaution technique during central venous catheter (CVC) placement have good recall~          after 3 months~   "
225079|NCT00612118|"~     This study is an 8 day, randomised, double blind, 2-way crossover trial of repeat doses of~     intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects~     with seasonal allergic rhinitis (SAR). Laboratory safety assessments, 12-lead~     electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the~     study. Nasal examination, symptom scores, and allergen challenge assessments will also be~     performed at various time points throughout the study.~   "
225080|NCT00612105|"~     The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing~     pain associated with post-herpetic neuralgia.~   "
225081|NCT00612092|"~     The objective of this study is to compare radiation dose of a standard spiral scan with the a~     new sequential scan protocol. We hypothesize that the sequential scan protocol is associated~     with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not~     inferior.~      Secondary endpoints of the study include quantitative image quality parameters, diagnostic~     accuracy for spiral versus sequential studies compared to invasive angiography in patients~     who underwent subsequent invasive coronary angiography.~   "
225082|NCT00612079|"~     This study aims to further validate and extend our previous findings insofar that the effect~     of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating~     processes and its relationship to cognitive performance shall be explored.~   "
225083|NCT00612066|"~     RATIONALE: Rosiglitazone may help pituitary tumor cells become more like normal cells, and to~     grow and spread more slowly.~      PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients~     with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).~   "
225084|NCT00612053|"~     The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational~     study will appraise the prevalence, management strategy, and prognosis of unprotected left~     main coronary artery disease in Italy.~   "
225085|NCT00612040|"~     This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of~     this trial is to compare two NN1250 (insulin degludec) formulations with each other and with~     insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.~   "
225086|NCT00612027|"~     Under daily routine conditions and without any intervention by the sponsor regarding the~     selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non-~     medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians~     (i.e. general practitioners and internists) are asked to document relevant data related to~     esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid~     associated gastrointestinal symptoms can be included.~   "
225087|NCT00612014|"~     The purpose of this study is to determine whether TZP-101 is effective in the treatment of~     symptomatic gastroparesis due to diabetes.~   "
225088|NCT00612001|"~     RATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build~     an effective immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with malignant glioma.~   "
225089|NCT00611988|"~     We are conducting a clinical research trial to determine the role of self-managed walking~     therapy to improve walking ability in patients with diabetes mellitus and peripheral arterial~     disease (PAD). PAD, commonly referred to as poor circulation in the legs, is a very common~     disease in patients with diabetes mellitus. For patients with PAD, there is a significant~     risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy~     but the traditional methods for the delivery of this treatment have required frequent visits~     to a university or hospital-based site. We will address the role of self-managed walking~     program, to be conducted at or near the home, to improve limb function.~   "
225090|NCT00611975|"~     This study will evaluate the effect of antidepressants on sex hormone levels in women and if~     the potential changes in sex hormone levels are related to sexual side effects.~   "
225091|NCT00611962|"~     To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor~     response rate using World Health Organization/Union Internationale Contre le Cancer~     (WHO/UICC) and Indianapolis tumor marker (human chorionic gonadotropin [hCG], alpha~     fetoprotein [AFP]) criteria in metastatic germ cell cancer patients~   "
225092|NCT00611949|"~     The purpose of this study is to determine which component of an artificial geranium oil helps~     to reduce your neuropathy pain.~   "
225093|NCT00611936|"~     A total of 18 healthy volunteers will participate in this four-week, within-groups,~     double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day~     washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or~     placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After~     receiving medication or placebo for three days, subjects will have a 6-hour laboratory~     session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg~     maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and~     subjective outcome measures will be obtained during the experimental sessions. Subjects will~     then have a 4-15 day washout period and will be crossed over to the alternative treatment for~     Phase II.~   "
225094|NCT00611923|"~     This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual~     dysphoric disorder.~   "
225095|NCT00611910|"~     The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents~     to reduce reblockage of bypass grafts after coronary stenting~   "
225096|NCT00611897|"~     This study tests the hypothesis that extrasynaptic mechanisms are critically linked with~     cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in~     healthy humans.~   "
225099|NCT00611858|"~     The standard treatment for rectal cancer is to receive the chemotherapeutic drug~     5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal~     cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is~     to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given~     with 5-FU and radiation therapy. The epidermal growth factor (EGF) receptor, which is found~     in rectal cancer, is a specific part of the cancer that is felt to encourage tumor growth.~     Cetuximab targets and blocks the EGF receptor and has been shown to be safe and effective in~     treating colorectal cancer and head and neck cancers.~   "
225100|NCT00611845|"~     This is a special access protocol that will allow physicians access to aprotinin during the~     temporary marketing suspension. The program will provide aprotinin for treatment of surgical~     patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary~     bypass (CPB) who are at increased risk of bleeding and transfusion when, in the opinion of~     the treating physician, the patients require it, there is no acceptable alternative therapy,~     and when there is a clearly favorable benefit-risk for the drug in that individual patient.~   "
225101|NCT00611832|"~     Researchers are developing and experimentally evaluating two variants of a 10-episode, brief~     (12 minutes per episode), infotainment-style television series targeted at parenting~     practices, to determine the potential value of television for bringing evidence-based~     parenting practices to parents. The study compares an information-only version of the~     television series against an enhanced version that is designed to actively promote parents'~     adoption of the targeted strategies. Both versions of the series are compared against a~     waitlist control group. The media series is derived from the Triple P Positive Parenting~     Program.~   "
225102|NCT00611819|"~     The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment.~      Combination of Peg interferon and Ribavirin is the best treatment because it improve the~     compliance of treatment.~      In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of~     treatment response was 64% and the sustained virological response (24 weeks after the end of~     treatment) 62%.~      In mono-infected patients trials showed there are not differences in the sustained~     virological response between 24 and 48 weeks of treatment, however exit the doubt concerning~     the different kinetic viral in HIV-HCV co-infected patients and this could be related with a~     lost of profit with a shorter duration of treatment, only 24 weeks.~      In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected~     patients genotype 2 or 3 will have the same rate of clearance of virus at the end of~     follow-up period.~   "
225103|NCT00611806|"~     This study will evaluate the effectiveness of folate and B12 supplementation in reducing~     negative symptoms in people with schizophrenia.~   "
225104|NCT00611793|"~     PTK787/ZK222584 is an orally active inhibitor of VEGF-R tyrosine kinases. Bevacizumab is an~     intravenous humanized monoclonal antibody directed against vascular endothelial growth~     factor. By binding to VEGF, bevacizumab blocks VEGF-A receptor binding. Due to the different~     mechanisms of action and the non-overlapping toxicity profiles of the two agents, it is hoped~     that a combination regimen incorporating both compounds will produce increased activity~     without enhanced toxicity.~   "
225105|NCT00611780|"~     The objective of this study is to compare radiation dose of a 100kV scan protocol to the~     standard 120kV scan protocol. We hypothesize that the 100kV scan protocol is associated with~     a reduction in dose estimates of at least 20%, while the diagnostic image quality is not~     inferior.~      Secondary endpoints of the study include quantitative image quality parameters, diagnostic~     accuracy for 120 vs.100kV studies compared to invasive angiography in patients who underwent~     subsequent invasive coronary angiography~   "
225106|NCT00611767|"~     This Project will explore the hypothesis that individuals with a family history positive for~     alcohol dependence (without any current Axis I disorder, except nicotine dependence),~     experience an alteration in the reward valence (balance of positive and negative effects)~     of the GABAA receptor agonist barbiturate (thiopental) compared to family history negative~     age-matched subjects. Further, variation in genes involved in brain GABA function may~     influence the risk for alcoholism by altering a component of the discriminative stimulus~     effects of ethanol.~   "
225107|NCT00611754|"~     To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU)~     in patients with advanced inoperable or metastatic head and neck cancer and to investigate~     the safety profile of this regimen in the above indication and consider other criteria of~     efficacy (clinical benefit, survival)~   "
225108|NCT00611741|"~     This study is designed to test the hypothesis that plasma osmolality is linked with cortical~     glutamate concentrations in the brain. It also investigates whether the glutamate response in~     schizophrenia is enhanced compared to healthy controls.~   "
225109|NCT00611728|"~     Primary Objectives To determine maxi tolerated dose & dose limiting toxicity of SU011248 +~     Irinotecan in recurrent MG pts not on EIAEDs To characterize safety & tolerability of~     SU011248 + Irinotecan among pts w recurrent MG Secondary Objectives To evaluate~     pharmacokinetic profile of SU011248 & Irinotecan when co-administered in pts w MG To evaluate~     anti-tumor activity of SU011248 + Irinotecan~   "
225110|NCT00611715|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving letrozole together with erlotinib may kill more tumor cells.~      PURPOSE: This phase II clinical trial is studying how well giving letrozole together with~     erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or~     progesterone receptor-positive locally recurrent or metastatic breast cancer.~   "
225111|NCT00611702|"~     Doctors have had success preventing certain types of kidney transplant rejection by~     suppressing the immune system. However, an individual's genetic make-up and the strength of~     an immune response to a transplant may also determine whether a transplanted organ is~     rejected. The purpose of this study is to look at the genetic profile and immune response of~     people who have had kidney transplants and to correlate the findings with kidney transplant~     rejection episodes. Donor genetic profiles will also be studied and correlated with the~     recipient's information.~   "
225128|NCT00611481|"~     Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures~     of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease~     Rating Scale, Falls, muscle strength.~   "
225112|NCT00611689|"~     In this phase I study, the investigators will determine the maximum tolerated doses of~     imatinib and PTK/ZK administered in two different dose schedules. Due to the different~     mechanisms of action and the minimally-overlapping toxicity profiles of these two novel oral~     agents, it is hoped that a combination regimen incorporating both compounds will produce~     increased activity without enhanced toxicity. After completion of this phase I study, the~     investigators propose a follow-up phase II study in patients with previously treated~     metastatic renal cell cancer - where VEGF and PDGF appear to play important roles in the~     malignant phenotype - to determine the antitumor efficacy of the recommended dose of this~     combination regimen.~   "
225113|NCT00611676|"~     This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may~     receive Venlafaxine or placebo during the course of the trial. All subjects will, in fact,~     receive placebo for the first two weeks. All subjects will then be placed on 150-225 mg per~     day of venlafaxine. Primary outcome assessment will compare pain intensity at 2 weeks (after~     placebo) to that at 12 weeks (after 10 weeks of Venlafaxine treatment).~      Study Hypothesis:~      In subjects who continue to have activity-limiting osteoarthritis pain after treatment with~     acetaminophen or non-steroidal anti-inflammatory agents, 150-225 mg Venlafaxine per day over~     10 weeks will provide significant additional pain relief over that achieved with placebo~     (more than 30% reduction after Venlafaxine treatment).~   "
225114|NCT00611663|"~     The aim of this study is to compare the immunological efficacy of two pneumococcal~     vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with~     corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost~     strategy using vaccination with conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic~     vaccine (Pneumo23®) after 6 months (W24)2) compared to the standard vaccination with Poly~     Saccharidic vaccine (Pneumo23®) at W24 after placebo at W0~   "
225115|NCT00611650|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of Polyphenon E, a substance found in green tea, may keep cancer from forming in current or~     former smokers with bronchial dysplasia.~      PURPOSE: This randomized phase II trial is studying the side effects and how well green tea~     extract works in treating current or former smokers with bronchial dysplasia.~   "
225116|NCT00611637|"~     The purpose of this study is to determine the safety and feasibility of CMV specific, T cell~     adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation~     for malignant disease.~   "
225117|NCT00611624|"~     The purpose of this study is to determine if Mammosite Catheter optimization using multiple~     dwell position delivery decreases skin toxicity over historically reported skin toxicity with~     the single dwell delivery method.~   "
225118|NCT00611611|"~     This protocol tests whether changes in BLyS or IFN can be detected in a normal immune~     response to a vaccine and, if so, whether the response differs between those with lupus and~     healthy controls.~   "
225119|NCT00611598|"~     The purpose of this study is to help us better understand the cellular changes that may lead~     to the development of lung cancer. We want to compare people with a second primary lung~     cancer with those who have only a first primary lung cancer. We hope to use the information~     obtained in this study as the basis for future studies and will not regard the results from~     this study as final.~      We will analyze your blood cells and DNA to measure the changes in several genes that we~     believe may be involved in lung cancer. We also want to evaluate the capacity for your DNA to~     repair itself.~   "
225120|NCT00611585|"~     The purpose of this study is to meet a PMA condition of approval of the BHR System. The study~     will evaluate the long term safety and effectiveness of the BHR system in patients with~     non-inflammatory and inflammatory arthritis.~   "
225121|NCT00611572|"~     This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism~     and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by~     ERPs (event-related potentials) in healthy volunteers.~   "
225122|NCT00611559|"~     The new formulation administered as a 4th consecutive dose will be compared to the current~     formulation of the vaccine in this partially double blind study.~      The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study~     will be open with respect to the DTPa-HBV-IPV group.~   "
225123|NCT00611546|"~     In an effort to decrease the load of peroxides in TPN solutions, multiple studies examined~     different strategies such as photo-protection, adding multivitamins to the lipid emulsion~     rather than to the dextrose-amino acid admixture, and adding antioxidants such as glutathione~     to the TPN solution. However, the role of trace elements as antioxidants, and their~     interaction with light have not been studied. Also, the impact of TPN-related oxidants on~     clinical morbidities has not been addressed. Therefore, we aimed in this study of preterm~     infants to evaluate the role of different components of TPN on urinary peroxides and to~     examine the biochemical and clinical effects of light protection.~   "
225124|NCT00611533|"~     The purpose of this study is to examine the efficacy of atomoxetine (ATX) treatment for the~     mild to moderate cognitive disturbances frequently experienced by women during the menopause~     transition. In addition, we seek to determine, using the Brown Attention Deficit Disorder~     Scale (BADDS), whether and to what degree peri- and early post-menopausal women experience~     cognitive disturbances which overlap with the impairments of executive function~     characteristic of adults with attention deficit disorder (ADHD).~   "
225125|NCT00611520|"~     Under daily routine conditions and without any intervention by the sponsor regarding the~     selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non-~     medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians~     (i.e. pneumologists and internists) are asked to document relevant data related to the~     budesonide/formoterole therapy in patients with COPD.~   "
225126|NCT00611507|"~     This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the~     efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in~     advanced colorectal cancer~   "
225127|NCT00611494|"~     The purpose of the study is to assess the gastrointestinal tolerability of EC-MPS compared to~     MMF in maintenance transplant patients on a calcineurin inhibitor regimen, who require MMF~     dose reductions of 25% or more due to GI complications. The tested hypothesis is that the~     EC-MPS treatment is superior to the MMF therapy in terms of tolerability and that patients on~     the EC-MPS formulation will be able to tolerate higher doses compared to those on MMF.~   "
225130|NCT00611455|"~     This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a~     duration of 24 weeks, followed by a 120 week Open-label Period. the primary purpose of the~     study is to demonstrate the efficacy of ofatumumab in reducing clinical signs and symptoms in~     adult RA patients after a single course of ofatumumab.~   "
225131|NCT00611442|"~     The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by~     the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the~     prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and~     size of polyps detected on examination.~   "
225132|NCT00611429|"~     This study will develop and test the effectiveness of an educational and supportive~     counseling program called Preparing Patients to Start Antiretroviral Therapy in helping~     people with HIV make informed decisions about their health care.~   "
225133|NCT00611416|"~     The aim of this study is to elucidate the role of specific catechins, a mixture of catechins~     and caffeine in relation to weight control with particular emphasis on energy metabolism and~     fat oxidation.~   "
225134|NCT00611403|"~     This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion~     administered twice daily following LASIK surgery~   "
225135|NCT00611390|"~     This randomized, double blind, parallel group study, compared the efficacy of spray~     containing aromatic essential oils of some herbal plants, against placebo in the treatment of~     patients with acute viral Laryngitis or Tracheitis.~      Study objectives: Primary to demonstrate a hoarseness or cough relief within 20 minutes after~     first administration of treatment with the spray.~      Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and~     signs comparing baseline therapy from the beginning to the end of 3 days treatment~   "
225136|NCT00611377|"~     Delirium is rather common among patients in Intensive Care Units (ICU), while little is known~     about its incidence in ventilator-dependent patients transferred to a Weaning Center (WC),~     once in a phase of clinical stability. We will prospectively evaluate for the presence of~     delirium all the ventilator-dependent patients admitted to our WC over a period of two years.~     They will be monitored using the Intensive Care Delirium Screening Checklist (ICDSC),~     previously validated in the ICU setting. This evaluation is based on a score based on 8 items~     obtained with a simple examination by the attending physician. The final sum generates a~     score considered normal (0-1), borderline (2-3) and pathologic (>4). All the patients, except~     those with normal score, will also be evaluated by a psychiatrist, using the Diagnostic~     Manual of Mental Disorders (DSM-IV), considered the gold standard. The score will be assessed~     at patient's admission, at mid-hospital stay and at discharge.~   "
225137|NCT00611364|"~     Physical therapy for hipertensive elderly: effects in the physical activity and exercise~     adherence.~      Introduction: The arterial hypertension (AH) is a clinical syndrome characterized by blood~     pressure ≥ 140/90mmHg. Practical of physical activity (PA) and/or physical exercise (PE) is~     one of the modalities of not farmacological treatment. Hypertensive aged not adhere to this~     recommendation for presenting factors that make it difficult this practical. Objective: to~     verify if physical therapy (PT) treatment can improve the AF and EF adhesion of hypertensive~     aged. Methods: The sample was composed by 43 hypertensive aged of Arterial Hypertensive~     League of the Federal University of Goiás. Of these, 30 had remained in the study and had~     been randomized in study group (SG) (16 patients) and control group (CG) (14 patients). SG~     was submitted of the PT treatment and participated of educative meetings, the CG only~     participated of the meetings. To evaluate adhesion to the AF was used the pedometer and EF~     was used a questionnaire of open and closed questions, six minute walk test (6`WT) and~     ergometric test (ET).~   "
225138|NCT00611351|"~     RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell~     transplant helps stop the growth of cancer cells and helps stop the patient's immune system~     from rejecting the donor's stem cells. When certain stem cells from a donor are infused into~     the patient they may help the patient's bone marrow make stem cells, red blood cells, white~     blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune~     response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after~     the transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving busulfan together with~     cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in~     treating patients with hematologic cancer.~   "
225139|NCT00611338|"~     This research study will examine the usefulness of groups in reducing stress and helping~     individuals with HIV to stay healthy and avoid problems associated with sexually transmitted~     diseases. We hope to discover whether being in a group is effective in reducing~     stress-related symptoms and promoting healthy behaviors.~   "
225140|NCT00611325|"~     Primary Objective To estimate 6-month progression free survival probability of patients with~     recurrent glioblastoma multiforme treated with bortezomib plus Avastin. This efficacy~     assessment will be made separately among patients on enzyme-inducing anti-epileptic drugs and~     non enzyme-inducing anti-epileptic drugs.~      Secondary Objectives To evaluate safety & tolerability of bortezomib plus Avastin among~     patients with recurrent malignant glioma.~      To evaluate radiographic response, progression free survival & overall survival of patients~     with recurrent malignant glioma treated with bortezomib plus Avastin~   "
225141|NCT00611312|"~     The purpose of this study is to see if an intense two-week long cognitive training program~     helps the thinking ability of adults with very mild Alzheimer Disease. We anticipate that~     scores on clinical cognitive tests will be better after the training.~   "
225142|NCT00611299|"~     The purpose of the study was to investigate the dose-response effect of increasing doses of~     Bifidobacterium animalis ssp lactis (BB-12) and Lactobacillus paracasei ssp paracasei~     (CRL-431) on the immune response, blood lipids, gut microflora, recovery from feces and~     overall tolerance in healthy young adults.~   "
225143|NCT00611286|"~     The duration of dual antiplatelet treatment (i.e. asprin and clopidogrel) after drug-eluting~     stent implantation is highly debated. This study will evaluate the value of extending such~     treatment up to 2 years after the procedure as compared to conventional treatment according~     to our national health institute guidelines (i.e. minimum 1 month after bare metal stent and~     6 months after drug-eluting stent) on the composite endpoint of death, MI or stroke.~   "
225144|NCT00611273|"~     Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing~   "
225145|NCT00611260|"~     This is a trial to examine the effects of meditation on the incidence of ventricular~     arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators.~      We wish to test the following hypotheses:~        1. Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in~          patients with congestive heart failure.~        2. Vipassana meditation improves the psychological profile in patients with CHF. In this~          study, subjects meeting the inclusion and exclusion criteria will be recruited into the~          study after obtaining informed consent. The subjects will then be randomized into either~          an experimental group ( Meditation) or into a control group (usual care).~   "
225146|NCT00611247|"~     Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and~     efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis~   "
225147|NCT00611221|"~     OBJECTIVE: To measure the benefits of massage, administered by a registered massage~     therapist, to pain management for women in active labour.~      DESIGN: A randomized controlled trial.~      SETTING: BC Women's Hospital, a tertiary level maternity teaching hospital in Vancouver,~     British Columbia, Canada.~      PARTICIPANTS: Healthy first time mothers experiencing an uncomplicated pregnancy who present~     to the hospital in labour. Seventy women will be enrolled in each trial arm.~      MAIN OUTCOME MEASURES: The primary outcome is time to use of epidural analgesia measured as~     cervical dilatation at the time of epidural insertion. Secondary outcomes include use of~     epidural and narcotic analgesia, and measures of intensity and characteristics of pain.~      DATA ANALYSIS: Study outcomes will be compared among women randomized to receive a maximum of~     five hours of massage during labour administered by a registered massage therapist versus~     usual care. Analysis will be by intention to treat. Prognostics factors not balanced between~     trial arms (massage and usual care) will be controlled for in a multivariate analysis.~   "
225148|NCT00611208|"~     This is a Phase II clinical trial aimed at treating a subgroup of patients with cutaneous~     T-cell lymphoma. The drug consists of a toxin, called diphtheria toxin, which is attached to~     an antibody that can specifically target cancerous T-cells. Our primary objectives are,~     therefore, to determine the patient subgroup with respect to disease burden who best responds~     to this experimental drug in treating CD3 positive T cell malignancies. We will be~     determining how the patient and their disease respond to this research agent.~      The Clinical Response Data analysis from October 2014 done at the completion of the Phase I~     portion of A-dmT390-bisFv(UCHT1) fusion protein clinical trial showed that there were 25~     evaluable patients who received all 8 doses varying between 2.5 and 11.25 µg/kg per dose.~     There were responses at all the lower dose levels up to 7.5 µg/kg per dose. The overall~     response rate was 36% and the complete response rate was 16% (when followed for 6 months). We~     have identified a subgroup of CTCL patients that have a very high response rate. If we~     exclude patients whose mSWAT scores never exceeded 50 (50% of skin surface area times a~     multiplier) and who never had lymph node involvement or stage III disease we are left with 9~     patients. This subgroup has an overall response rate of 89% and a complete response rate of~     50% (when followed for 6 months). Of these 4 patients currently in complete remission, three~     are long-term responders. Two are over 6 years in duration and one over 5 years duration.~     These may represent cures. The long time periods in the transition from partial response to~     complete response without treatment, 6 months to two years, suggests that the study drug in~     addition to exerting a direct killing effect on tumor also functions as an immunomodulator.~   "
225149|NCT00611195|"~     To describe respiratory and laryngeal responses to laryngeal stimulation during propofol~     anesthesia in children with upper airway infections. To determine whether the~     co-administration of remifentanil blunts these reflex responses. To test whether the~     co-administration of remifentanil results in a significant reduction of apnea with~     laryngospasm in these patients.~      Hypotheses:~      I: In children with a URI undergoing anesthesia with propofol, the incidence of apnea and~     laryngospasm after controlled stimulation is expected to occur 2.5 times more frequently than~     in children without URI (20 vs. 8%).~      II: The incidence of apnea and laryngospasm is diminished after administration of~     remifentanil.~   "
225150|NCT00611182|"~     This study has two aims:~        1. To determine the relationship of shortness of breath (dyspnea) to other conditions~          present in patients with pulmonary fibrosis.~        2. To define the relationship between shortness of breath and rate of functional decline in~          patients with pulmonary fibrosis.~   "
225151|NCT00611169|"~     The purpose of this study to investigate whether the administration of high-dose tirofiban~     before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced~     magnetic resonance imaging.~   "
225152|NCT00611156|"~     The objective of this study is to examine whether four different spices (ginger, black~     pepper, horseradish and mustard) are able to increase energy metabolism.~      Since chili and other spices have been shown to increase energy expenditure compared to~     placebo, we expect that some or all of the four spices may actually increase energy~     expenditure - although not to a large degree.~   "
225153|NCT00611143|"~     The purpose of this study is to determine whether pretreatment with atorvastatin protects~     against atrial fibrillation following off-pump coronary artery bypass graft surgery.~   "
225154|NCT00611130|"~     The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated~     subjects than placebo-treated subjects will be cocaine-free in the last 2 weeks of treatment.~   "
225155|NCT00611117|"~     The study is designed to determine the effect of high physical activity level vs. low~     physical activity level on the adaptation to a high fat diet.~   "
225156|NCT00611104|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood~     and urine in the laboratory from participants receiving freeze-dried table grape powder may~     help doctors understand the effect of this drug on blood estrogen levels.~      PURPOSE: This clinical trial is studying the effect of freeze-dried table grape powder on~     blood estrogen levels in postmenopausal women.~   "
225181|NCT00610779|"~     This randomized, double blind, parallel group study, compared the efficacy of spray~     containing aromatic essential oils of some herbal plants, against placebo in the treatment of~     patients with acute Rhino-sinusitis.~      Study objectives: Primary to demonstrate a relief in the nasal obstruction within 20 minutes~     after first administration of treatment with the spray.~      Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and~     signs comparing baseline therapy from the beginning to the end of 3 days treatment~   "
225157|NCT00611091|"~     The incidence of drug-induced injury is high in the ambulatory geriatric population and is~     increased for elders upon transition from the hospital to the ambulatory setting. In this~     application, we describe an effort to build on our extensive experience in medication safety~     and HIT-based medication management to respond to the AHRQ RFA entitled Ambulatory Safety and~     Quality Program: Improving Quality through Clinician Use of Health IT (RFA-HS-07-006). In~     this study, we propose to develop and evaluate the value of an enhanced, HIT-based~     transitional care intervention superimposed on the ambulatory electronic medical record (EMR)~     to improve the quality and safety of medication management, focusing particularly on the~     transition from the inpatient to the ambulatory setting for older adults with multiple~     comorbid conditions who are prescribed high risk medications. We propose a randomized~     controlled trial of a HIT-based transitional care intervention with enhanced medication and~     therapeutic monitoring alerts to improve the quality and safety of patient monitoring and~     medication management. We postulate that the efficient and coordinated delivery of actionable~     health information to the clinician via use of HIT in the ambulatory setting can improve~     medication safety for the growing geriatric population. The specific aims for this study are~     to evaluate, among a population of older adults discharged from the hospital, the impact of~     an enhanced discharge information system initiated upon transition to the ambulatory setting:~     (1) on the rate of follow-up by an outpatient provider within 14 days of hospital discharge;~     (2) on the prevalence of appropriate monitoring for selected high risk medications at 30 days~     from the time of hospital discharge; (3) on the incidence of adverse drug events (ADEs) 30~     days after discharge; and (4) on the rate of emergency department visits and hospital~     readmission within 30 days of discharge. A secondary aim for this study is to determine costs~     directly related to the development and installation of the HIT-based transitional care~     intervention. This research allows for the examination of an integrated HIT intervention on~     the quality of follow-up, outpatient clinician workflow, occurrence of ADEs, and health care~     utilization to gain insights into the effective use of clinical alerts and coordinated~     delivery of actionable information to outpatient clinicians in the management of ambulatory~     elderly patients subsequent to hospital discharge.~   "
225158|NCT00611078|"~     The purpose of this study is to assess the feasibility of conducting a large hospital based~     case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans~     (PCDFs) and polychlorinated biphenyls (PCBs).~   "
225159|NCT00611065|"~     The goal is to develop MR imaging techniques to improve delineation of cancer extent, and to~     improve differential diagnosis between prostate cancer and benign prostate hyperplasia or~     other benign diseases.~   "
225160|NCT00611052|"~     The main purpose of this study is to assess the effect of a cognitive group intervention on~     prevention of major depression in 14-15-year-old adolescents. Moreover, the effect on other~     selected mental health parameters are investigated.~   "
225161|NCT00611039|"~     Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ)~     with the virological response, it is possible to think in the possibility of simplifying the~     rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being~     treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral~     load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the~     antiretroviral treatment and would have less impact in the lipid profile of the patients as~     well as less pharmaceutical expenditure.~   "
225162|NCT00611026|"~     To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo~     for overactive bladder~   "
225163|NCT00611013|"~     Evaluating novel MR imaging techniques on volunteers.~   "
225164|NCT00611000|"~     RATIONALE: Studying samples of blood and tissue from patients at risk of cancer in the~     laboratory may help doctors learn more about the effect of folate on DNA and identify~     biomarkers related to cancer.~      PURPOSE: This phase I trial is studying the effect of folate on DNA in colon tissue and~     peripheral blood samples from patients at increased risk of developing colorectal neoplasia.~   "
225165|NCT00610987|"~     It has been established that providing antibiotic prophylaxis after closed fracture fixation~     with implants or prosthetic devices has beneficial effects. However, the optimal duration of~     antibiotic prophylaxis after orthopaedic trauma surgery is not well-defined. Most studies~     comparing single-dose prophylaxis with multiple-dose prophylaxis have not shown beneficial~     effects of additional doses. Our proposed study is intended to further define the appropriate~     duration of antibiotic (cefazolin) administration for surgical prophylaxis in the treatment~     of closed fractures. We will randomly assigned patients into two groups, hopefully~     differentiated only by the duration of antibiotic administration (single dose vs. 24 hours).~     We will follow these patients until fracture healing and determine if there is a difference~     in the incidence of infection.~   "
225166|NCT00610974|"~     The research proposed here will determine the effect of a novel treadmill gait training~     strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with~     SCI. The effect of the new therapy will be evaluated by analyzing changes in functional~     ambulation and gait patterns during walking.~   "
225167|NCT00610961|"~     The increase immunosuppression in our transplant population has led to an unacceptable rate~     of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by~     switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK~     by PCR.~   "
225168|NCT00610948|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as panitumumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Giving everolimus together with combination~     chemotherapy and/or panitumumab may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with fluorouracil, leucovorin, panitumumab, and oxaliplatin in treating~     patients with solid tumors that did not respond to previous treatment.~   "
225169|NCT00610935|"~     The purpose of this study is to determine the safety and effectivess of a single~     intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated~     influenza.~   "
225170|NCT00610922|"~     To examine whether daily supplement of docosahexaenoic acid throughout the first year of life~     may speed up the achievement of gross motor development milestones in healthy infants, a~     total of 1160 healthy infants randomly allocated to receive throughout the first year of life~     daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3~     (400 IU) alone. Primary outcome measure: time of achieving gross motor development~     milestones. Secondary outcome measure: time of achieving early fine motor development~     milestones and language.~   "
225182|NCT00610766|"~     Estimation of radiation dose of coronary multislice computed tomography (MSCT) angiography in~     daily practice in an international, multicenter and vendor-independent trial.~   "
225183|NCT00610753|"~     This study will compare the effectiveness of two different family treatments for the~     treatment of adolescent anorexia nervosa.~   "
225171|NCT00610909|"~     Irritable bowel syndrome (IBS) is an extremely common disorder in the U.S population,~     affecting somewhere between 9-22% based on community based studies. IBS has a chronic~     relapsing course and overlaps with other functional gastrointestinal disorders. It accounts~     for high direct medical expenses and indirect costs including a significant degree of~     absenteeism. Most studies have suggested that there is a slight predominance among women,~     especially those that have suffered some form of physical or sexual trauma. It has been~     estimated that up to 25-40% of patients seen by gastroenterologists' are affected by IBS, and~     that 70-90% of these patients may have a psychiatric comorbidity, most commonly major~     depression and panic disorder, but also including schizophrenia, double depression, dysthymia~     and alcohol abuse.~      Abdominal pain and disturbance of bowel habits characterize the symptoms of IBS in the~     absence of demonstrable structural pathology. The diagnosis of IBS relies upon clinical~     criteria alone, as there is no gold standard in laboratory findings. The diagnosis is~     dependent upon identifying characteristic symptoms, and then differentiating IBS from other~     structural bowel disorders. Previously, the diagnosis of IBS was based upon a consortium~     recommendation that examined and defined diagnostic criteria for over 100 functional~     gastrointestinal disorders. These criteria became the most definitive in the area of~     functional disorders and are referred to as the Rome Criteria. During the time since this~     consensus, these criteria have been modified, and in 1999 became the foundation for the~     second set of diagnostic criteria by consensus, now referred to as the Rome II criteria. The~     revised Rome II criteria include only the first part of the original criteria, but now~     require the presence of two out of three symptoms relating abdominal pain to bowel symptoms.~      We designed our study and a Randomized, double-blind, parallel-group, flexible-dose,~     placebo-controlled 12-week study.~   "
225172|NCT00610896|"~     This study is looking at cardiac rhythm management (CRM) and fusion beats in patients who~     have a pacemaker or implantable cardioverter-defibrillator (ICD), to determine if there is a~     correlation between the time between the contraction of the upper chambers of the heart~     (atrium) and the lower chambers of the heart, (ventricle) and heart function.~      Some studies of people with pacemakers have been done to determine if shortening the time of~     contraction between the atrium and ventricle could benefit the function of the left~     ventricle. These studies have shown that there is no benefit in heart function.There have~     been other studies which have shown that chronic pacing of the right ventricle, especially~     with the lead placed at the tip of the right ventricle, can lead to a decrease in the~     function of the left ventricle and congestive heart failure. In some patients long term~     pacing of the right ventricle has also been associated with a reduction in the ability of the~     left ventricle to pump blood. This is know as a reduced left ventricular ejection fraction,~     which can be documented by an echocardiogram.~      This study proposes to evaluate the acute effects of progressive paced fusion beats on the~     left ventricle to answer the question whether there is an delay between the atrium and~     ventricle that is too long or too short.~   "
225173|NCT00610883|"~     Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may~     return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6~     months. To aggressively treat this cancer this study uses effective drugs in three parts:~        -  Induction ends on day 19~        -  Consolidation ends on day 38 or 42~        -  Maintenance may include up to 6 cycles~   "
225174|NCT00610870|"~     The purpose of this study to determine whether statin pretreatment decrease myocardial~     infarct size in patients with acute myocardial infarction undergoing primary percutaneous~     coronary intervention.~   "
225175|NCT00610857|"~     To determine the safety and efficacy of the combination of HDI and anti-CTLA-4 monoclonal~     antibody for patients with recurrent inoperable stage III or stage IV melanoma.~   "
225176|NCT00610844|"~     The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by~     pathological correlation and to characterize the tissue response after treatment of primary~     and secondary pulmonary tumors.~   "
225177|NCT00610831|"~     The objective of this study is to collect an image library of diagnostic digital mammograms~     using the Carestream CR mammography system from patients who have histological-conformed~     breast cancer to demonstrate the clinical feasibility of this system for detection of breast~     cancer.~   "
225178|NCT00610818|"~     We are approaching you to participate in this study because you are taking Palifermin and the~     purpose of this study is to describe the effect of Palifermin on skin growth found on the~     body. Palifermin is a new synthetic growth factor (encourages skin cells to grow)~     specifically designed to protect the areas of the body (mouth and upper digestive tract) that~     are damaged by chemotherapy. The cells in these areas are rapidly dividing cells and so are~     killed by chemotherapeutic drugs. Palifermin is a drug that stimulates new cells in these~     areas to grow and therefore protects patients from some serious side effects of chemotherapy.~     These include mucositis or inflammation of the lining of the mouth and other organs resulting~     in difficulty swallowing, speaking and extreme pain in the mouth and upper digestive tract.~      Skin cells are also known to respond to these types of growth factors like Palifermin, but~     unfortunately no studies have been done that look specifically at the effect of this drug on~     pre-existing skin lesions or the development of new skin lesions. We will be asking you if~     you have noticed any change in moles or other skin lesions that you have, and if you have~     noticed any new lesions. We will also be doing a full physical examination of the skin at~     regular intervals during the study to document the appearance of any new lesions or change in~     pre-existing ones.~   "
225179|NCT00610805|"~     We propose a feasibility study of aggressive CV risk factor management directed by preventive~     cardiology compared to usual care. We will determine: 1) the efficacy of a preventive~     cardiology program compared to usual care in slowing the progression of carotid IMT and~     plaque, and 2) the effect of a preventive cardiology program versus usual care at achieving~     CV risk factor target goals.~      We hypothesize Lupus patients randomized to the preventive cardiology program will have less~     cardiovascular progression over two years than those lupus patients who are given standard~     care for cardiovascular risk, defined by carotid intima-media thickness and plaque.~   "
225180|NCT00610792|"~     This a Phase 2, multicenter open label, uncontrolled 2-step design. Patients will be arranged~     in two groups based upon the response to their last platinum containing therapy. The two~     groups are, 1) Platinum Resistant Patients: patients with progressive disease while on~     platinum containing therapy or stable disease after at least 4 cycles; patients relapsing~     following an objective response while still receiving treatment; patients relapsing after an~     objective response within 6 months from the discontinuation of the last chemotherapy and 2)~     Platinum-Sensitive Patients: patients who relapsed following an objective response after 6~     months from the discontinuation of platinum containing chemotherapy. All patients will~     receive pyridoxine at least 200mg by mouth daily beginning approximately one week prior to~     the initiation of the combination chemotherapy and it will continue up to the end of the last~     treatment cycle.~   "
225184|NCT00610740|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Using the CerviPrep™ drug delivery device to apply topical gemcitabine to the cervix may be~     an effective way to kill more tumor cells.~      PURPOSE: This phase II trial is studying how well CerviPrep™ works in applying topical~     gemcitabine to the cervix in treating patients with primary endometrial cancer, cervical~     cancer, or ovarian epithelial cancer.~   "
225185|NCT00610727|"~     To evaluate the tolerability and safety of inhaled prochlorperazine To evaluate the~     pharmacokinetics of inhaled prochlorperazine~   "
225186|NCT00610714|"~     The main purpose of this study is to determine if AZD0530 can improve the efficacy of~     standard chemotherapy for the treatment of ovarian cancer~   "
225187|NCT00610701|"~     The purpose of this study is to evaluate patients with tibial plateau fractures.~   "
225188|NCT00610688|"~     The purpose of this research study is to compare the effects of higher dose vitamin D with~     commonly recommended dose in pregnant women to see which is better in achieving and/or~     maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well~     as improving growth in the infant.~   "
225189|NCT00610675|"~     This trial is a 52-week, open-label extension trial to investigate safety and to explore~     efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706)~     (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol~     P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate~     in Protocol 176004 (P05708) after signing informed consent.~   "
225190|NCT00610662|"~     RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and~     diagnose cervical intraepithelial neoplasia.~      PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in~     finding cervical intraepithelial neoplasia in patients with an abnormal Pap smear.~   "
225191|NCT00610649|"~     Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of~     MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.~   "
225192|NCT00610636|"~     The role of surgical resection in the subset of patients with resectable hepatic metastases~     converted from initially non-resectable liver metastasis was still not clearly established.~     To further explore the oncologic results of surgical versus non-surgical methods for the~     treatment of this subset of patients, we designed and conducted the present randomized~     prospective study beginning in 2002. The present study was based on the following arguments~     against the predominant survival benefits of surgical resection in previous reported series:~     (1) The initially non-resectable liver metastasis was basically a disseminated disease, even~     though some metastases were highly responsive to chemotherapy and become resectable; (2)~     Since the evaluation of resectability was based on the imaging studies, it was difficult to~     consider the surgical resection as curative for the resectable hepatic metastases converted~     from non-resectable ones, given the limitation of the current imaging stools of~     high-technology; (3) The resectable hepatic metastases after neoadjuvant chemotherapy might~     represent a subset of hepatic metastases biologically highly responsive to chemotherapy and~     the time-to-progression for these metastases might be fairly long after a response.~     Additionally, these metastases might be also biologically responsive to other cytotoxic or~     targeted therapies that justified the patients' continuous adoption of non-surgical~     treatment.~   "
225193|NCT00610623|"~     The purpose of this study is to assess the clinical efficacy of azithromycin, used as a~     quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of~     pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.~   "
225194|NCT00610610|"~     Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with~     fibromyalgia, information on the clinical implications of this comorbidity is limited. We~     investigated whether a history of depressive and/or anxiety disorders was associated with~     response to treatment in a double blind, randomized, placebo controlled trial of paroxetine~     controlled release (CR) in fibromyalgia.~      Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine~     CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric~     Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and~     anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but~     those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were~     assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI);~     subjects were excluded if they scored greater than 23 on the BDI. Health Status was~     determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale~     (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The~     primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact~     Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical~     Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual~     Analogue Scale for Pain (VAS) scores and number of tender points.~   "
225195|NCT00610597|"~     Alcoholic liver disease is characterized by circulating T cell activation and liver T cell~     infiltration but their phenotype is poorly studied. The aim of the study is to test the~     hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in~     alcoholic liver disease.~   "
225196|NCT00610584|"~     Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there~     is only limited evidence of its effectiveness. The aim of this three armed randomised~     controlled multicentre trial is to investigate the efficacy of acupuncture plus rescue~     medication vs. minimal (sham) acupuncture plus rescue medication vs. (b) rescue medication~     alone in the treatment of seasonal allergic rhinitis.~   "
225197|NCT00610571|"~     Objectives:~        -  To determine the maximum tolerated dose of oral topotecan when administered with Temodar~          to patients with malignant glioma~        -  To characterize any toxicity associated with the combination oral topotecan and Temodar.~        -  To observe patients for clinical antitumor response when treated with oral topotecan and~          Temodar.~   "
225198|NCT00610558|"~     This study will use MRI and PET scan to compare the brain imaging results between epilepsy~     patients and normal healthy controls, also to study changes in 3 years.~   "
244609|NCT00352261|"~     The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and~     lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients~   "
225199|NCT00610545|"~     This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG~     coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular~     outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in~     comparative standard doses in the perioperative period of major vascular surgery.~      Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs~   "
225200|NCT00610532|"~     The study is being done to understand why some patients with epilepsy (disease of recurrence~     of seizures) do not respond very well to drug treatment with anticonvulsants.~      Despite the availability of many anticonvulsants, about 30% of patients with epilepsy are~     resistant to them. The cause of the resistance is not clear, but one of the reasons could be~     an increased amount of proteins in the cells of the body called transporter proteins.~      Transporter proteins are a group of proteins that help to defend the body against toxins,~     including drugs, by pumping them out of the cells. Studies have shown that the number of~     transporter proteins is higher in the parts of the brain that trigger seizures when compared~     to other parts of the brain.~      Studies in animals have shown that taking an anticonvulsant with an inhibitor (meaning to~     stop or to reduce) of a transporter protein can increase the concentration of that~     anticonvulsant inside the brain cells. The main purpose of the study is to determine if~     taking an anticonvulsant and a transporter protein inhibitor will change the brain~     concentration of the anticonvulsant.~      In this study, a single dose of phenytoin (Dilantin® is a brand name anticonvulsant which has~     phenytoin as its active ingredient), a commonly used anticonvulsant, will be given once by~     itself, and then will be given a separate time with a single (i.e. one time only) dose of~     probenecid. Probenecid, a medicine used commonly to treat gout (a disease of increased uric~     acid), is known to be an inhibitor of transporter proteins. The study will use~     electroencephalogram or EEG (recording of brain wave activities) to determine if the EEG~     pattern when probenecid is given, will be different from the EEG pattern when phenytoin is~     given alone. This will suggest that probenecid has affected the brain concentration of~     phenytoin.~   "
225201|NCT00610519|"~     This randomized, double blind, parallel group study, compared the efficacy of spray~     containing aromatic essential oils of some herbal plants, against placebo in the treatment of~     patients with acute viral Pharyngo-tonsillitis.~      Study objectives: Primary to demonstrate a throat pain relief within 20 minutes after first~     administration of treatment with the spray.~      Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and~     signs comparing baseline therapy from the beginning to the end of 3 days treatment~   "
225202|NCT00610506|"~     Aims of Study:~      The aims of this study are 1) to examine the clinical utility of escitalopram in patients~     with major depression with atypical features; 2) to evaluate the tolerability of escitalopram~     in major depression with atypical features.~      Study hypothesis and objectives. This study is proposed as an open-label study to gather~     pilot data to examine whether escitalopram has clinical utility in the treatment of major~     depression with atypical features. Because of the exploratory nature of the design, no~     specific study hypotheses can be generated regarding efficacy of the drug. Our primary~     hypothesis is that the effect size of escitalopram in atypical depression will be similar to~     the effect size of escitalopram in major depression, its FDA approved indication.~   "
225203|NCT00610493|"~     The goal of this clinical research study is to find the highest tolerable dose of Avastin~     (bevacizumab) and Torisel (temsirolimus) that can be given, in combination, to patients with~     advanced cancer that has spread or is unable to be surgically removed. The safety of this~     drug combination will also be studied.~   "
225204|NCT00610480|"~     The goal of this research is to evaluate and compare the effectiveness of Systane® versus~     Optive™ and Soothe™ on aqueous tear film stability in patients with a diagnosis of Dry Eye~     Syndrome and to determine the possible application for this product in the future. Systane®~     is marketed as over-the-counter tear lubricating therapy in the United States under the FDA~     monograph.~   "
225205|NCT00610467|"~     This study will investigate whether adding the optical imaging to magnetic resonance imaging~     can improve the diagnostic specificity of breast cancer.~   "
225206|NCT00610454|"~     Subjects receiving LEV as adjunctive therapy to 1 or 2 other AEDs for partial onset seizures~     and subjects who are temporarily unable to take oral LEV, may require alternative routes of~     administration. The purpose of this trial was to evaluate the safety and tolerability of 1000~     to 3000 mg/day LEV administered as a 15-min IV infusion b.i.d. after switching from the same~     oral dose.~   "
225207|NCT00610441|"~     This is a Phase 2 multicenter, randomized, double-blind trial of MK-8777 (Org 26576, SCH~     900777) in adult subjects with Attention-Deficit/Hyperactivity Disorder (ADHD). MK-8777 or~     placebo will be administered in a crossover fashion for two 3-week treatment periods. The two~     3-week treatment periods will be separated by a 2-week placebo washout period.~      The primary objective is to compare the efficacy of various doses of MK-8777 to that of~     placebo in the treatment of ADHD symptoms in adults.~   "
225208|NCT00610428|"~     Development of Staccato Prochlorperazine for the treatment of migraine headache.~   "
225209|NCT00610415|"~     To see if a limited sampling of tumor tissue from human subjects is a feasible way to gather~     adequate tissue for cancer stem cell quantification.~   "
225210|NCT00610402|"~     Sturge-Weber Syndrome (SWS) is a neurological disorder characterized at birth by seizures and~     a large port-wine stain birthmark on the forehead and upper eyelid of one side of the face.~     SWS is also accompanied by an increased pressure within the eye (glaucoma) which can develop~     very early in life.~      Glaucoma represents a group of ocular disorders that are characterized by the loss of retinal~     ganglion cells and their axons, damage to the optic nerve, and gradual loss of visual field.~     Recently, several studies provided evidence that there is a potential role of the immune~     system in the pathogenesis of glaucoma.~      These findings suggest that there might be changes in systemic humoral immunity possibly~     underlying the optic neuropathy in at least some glaucoma patients.~   "
225211|NCT00610389|"~     Background: cellular immunotherapy with dendritic cells (DC) loaded with tumor antigens has~     shown clinical activity, although in a small number of patients. Therefore, is is mandatory~     to improve the results of this strategy and to closely monitor immunologic response and cell~     migration in order to improve our understanding of mechanisms of action and to settle future~     fields of development..~      Objectives: Primary: to confirm clinical activity of this strategy, determining tumor~     response (RECIST criteria). Secondary: to determine: (1) safety; (2) antitumoral immune~     response and (3) DC migration in the organism~      Methodology: phase II trial in patients with advanced renal cell carcinoma and melanoma. We~     will perform repeated immunizations with DC loaded with the patient´s tumor.~   "
225212|NCT00610376|"~     The primary objective of this preschool intervention trial was to determine whether a hygiene~     program can promote handwashing and thereby reduce illness absenteeism.~   "
225326|NCT00608816|"~     Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the~     hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and~     cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.~   "
225213|NCT00610363|"~     This was a clinical research study to determine the safety and effectiveness of an~     experimental drug called rilonacept in participants with gout who were beginning another~     additional treatment. Participants participated in this study for approximately 24 weeks.~     Rilonacept was being studied for use in preventing gout attacks in participants who had gout.~   "
225214|NCT00610350|"~     The aim of this study is to investigate whether pharmacological pre-treatment with~     levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective~     myocardial revascularization under cardiopulmonary bypass.~   "
225215|NCT00610337|"~     This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be~     conducted in North America and Europe and will include male and female subjects with acute~     cervical SCI, 18 to 62 years of age, who receive clinical trial material (CTM) within 72~     hours of injury.~      This study is being undertaken to evaluate and confirm the safety and efficacy of CETHRIN®.~     This adaptive study has been designed to efficiently identify the safest and most effective~     dose in Phase IIb which will be evaluated in a future Phase III study. Given the current lack~     of effective treatments for SCI, an improvement in motor ability or activities of daily~     living in these subjects would be a great advancement in the treatment of SCI.~   "
225216|NCT00610324|"~     Oropharyngeal bacteria play an important role in the pathogenesis of nosocomial pneumonia in~     critically ill patients. Oral cleansing with chlorhexidine has been shown to decrease~     incidence of pneumonia in patients undergoing open heart surgery. Its role in critically ill~     general ICU patients is not yet proven. The present study proposes to study the effectiveness~     of twice-daily oral cleansing with 0.2% chlorhexidine solution on the incidence of nosocomial~     pneumonia in ICU patients admitted to a single intensive care unit of an Indian public~     hospital~   "
225217|NCT00610311|"~     Background:~        -  gp100 is a protein that is often found in melanoma tumors.~        -  An experimental procedure developed for treating patients with melanoma uses anti-gp100~          cells designed to destroy their tumors. The anti-gp100 cells are created in the~          laboratory using the patient's own tumor cells or blood cells.~        -  The treatment procedure also uses a vaccine called plaque purified canarypox vector~          (ALVAC) gp100, made from a virus that ordinarily infects canaries and is modified to~          carry a copy of the gp100 gene. The virus cannot reproduce in mammals, so it cannot~          cause disease in humans. When the vaccine is injected into a patient, it stimulates~          cells in the immune system that may increase the efficiency of the anti gp 100 cells.~      Objectives:~      -To evaluate the safety and effectiveness of anti-gp100 cells and the ALVAC gp100 vaccine in~     treating patients with advanced melanoma.~      Eligibility:~      -Patients with metastatic melanoma for whom standard treatments have not been effective.~      Design:~        -  Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells~          for laboratory treatment.~        -  Patients have 7 days of chemotherapy to prepare the immune system for receiving the~          gp100 cells.~        -  Patients receive the ALVAC vaccine, anti-gp100 cells and interleukin-2 (IL-2) (an~          approved treatment for advanced melanoma). The anti gp100 cells are given as an infusion~          through a vein. The vaccine is given as injections just before the infusion of gp100~          cells and again 2 weeks later. IL-2 is given as a 15-minute infusion every 8 hours for~          up to 5 days after the cell infusion for a maximum of 15 doses.~        -  After hospital discharge, patients return to the clinic for periodic follow-up with a~          physical examination, review of treatment side effects, laboratory tests and scans every~          1 to 6 months.~   "
225218|NCT00610298|"~     The aim of this study is to accumulate data about the influence of whole body vibration on~     the functional recovery of adult patients with various neuromuscular and musculoskeletal~     deficits requiring physical medicine and rehabilitation treatments.~   "
225219|NCT00610285|"~     Stereotactic radiosurgery (SRS) is a way to accurately treat brain tumors. SRS involves the~     use of a special head frame to keep the head from moving during treatment. The head frame~     makes very accurate treatment possible. The frame must be attached to the skull with special~     pins. It feels very tight and can hurt. A special immobilization device can be used to keep~     the head from moving.~      This device does not need any pins and does not hurt. We would like to see if the new way of~     holding the head still can be used for SRS. This is the purpose of the study. New X-Ray~     machines can be used to find if the head has moved in the mask. We hope that we can use these~     new tools to treat brain tumors just as accurately without using a head frame. It will make~     treatment more comfortable for the patient. This is why we are asking patients to join the~     study.~   "
225220|NCT00610272|"~     Bone metastasis is one of the most frequent end complications of the cancer. Radiation~     therapy is the mainstay of treatment in this disease. Single fraction radiotherapy in both~     single and multiple bone metastasis is widely used, but optimization of the single dose~     fractionation is needed. Two different regimens of radiotherapy dose fractionation will be~     investigated in both single and multiple bone metastasis and endpoints will include pain~     relief as well as toxicity and quality of life.~   "
225221|NCT00610259|"~     The purpose of this study is to examine the effectiveness of brief behavioral therapy for~     insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for~     refractory insomnia among patients with major depression in partial remission.~   "
225222|NCT00610246|"~     The purpose of this study is to test the combination of radiation treatment and an~     anti-angiogenic drug called sorafenib (or BAY 43-9006 or Nexavar) to determine the effects of~     this combination on cancers but also on side effects of radiation treatment. This study will~     also determine the highest safe dose of sorafenib that can be given with radiation treatment.~   "
225223|NCT00610233|"~     The precise mechanisms underlying cerebral regulation of lower urinary tract (LUT) function~     are still poorly understood. Patients with deep brain stimulation (DBS) offer the unique~     opportunity to investigate the role of different cerebral centers on LUT function.~      We hypothesize that DBS has a significant effect on LUT function and that these effects~     depend on the specific stimulated cerebral center.~   "
225224|NCT00610220|"~     The study will compare the effectiveness of a prefabricated wrist splint with thermoplast~     reinforcements versus a short arm cast in skeletally immature children.~      The hypothesis is that the commercially available wrist splint is at least as effective as~     traditional casting with respect to recovery of physical function.~   "
225225|NCT00610207|"~     Healing anal fistulas in Crohn's patients with an anal fistula plug.~   "
225242|NCT00609986|"~     Purpose: The purpose of this study is to provide tight blood sugar control using insulin~     given through the veins at the time of kidney transplantation and up to 3 days after surgery.~     After release from the hospital, the patient will control blood sugar with subcutaneous~     insulin injections or pills. With this approach, outcomes should improve for diabetic~     transplant patients such as longer life of the new kidney, fewer hospital readmissions,~     decreased associated infections, and other advantages.~      Hypothesis: It is hypothesized that intensive glycemic control will lead to better clinical~     and biochemical outcomes and improved long-term graft survival.~   "
225226|NCT00610194|"~     Primary Objective: To evaluate the safety of escalating oral doses of RDEA119, a MEK~     inhibitor, in advanced cancer patients.~      Secondary Objectives:~        -  To describe the initial PK of different doses of RDEA119 when given once orally on Day 1~          of the study~        -  To describe the PK of different doses of RDEA119 when given orally as continuous dosing.~        -  To examine the inhibition of MEK products (p-ERK), cytokine products, and other protein~          biomarkers~        -  To expand the MTD dose cohort to evaluate the safety, tolerability and PK/PD of the~          recommended Phase 2 dose~        -  To explore the presence of genotype, PD markers, cell growth and a marker of apoptosis,~          in paired tumor biopsy samples of patients' tumors pre-dose and during dosing in a~          minimum of 10 patients in the expanded cohort~   "
225227|NCT00610181|"~     The goal of this clinical research study is to learn how often magnetic resonance imaging~     (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular~     cancer as well as in the breasts of young breast cancer patients (less than age 40 years).~     Researchers also hope to learn how often the results of the MRI changes the type of surgical~     treatment that is recommended and understand the costs associated with using MRI in the~     diagnostic process. Researchers also want to use a different way of looking at the MRI scans~     to learn if they can more easily learn the difference between a cyst and a tumor.~   "
225228|NCT00610168|"~     The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in~     adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only~     subjects who received booster vaccination in the previous clinical study are eligible for~     participation in this study.~   "
225229|NCT00610155|"~     This study is a methodology study designed to discover whether a brain imaging technology is~     a better way of compare the relative sensitivities of fMRI and subjective psychometric~     assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical~     study design.~   "
225230|NCT00610142|"~     to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on~     unaffected forehead skin~   "
225231|NCT00610129|"~     The purpose of this study is to test a new drug for neuroendocrine tumors. We think that this~     new drug may help control your tumor.~      MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific~     target on cancer cells. This target helps the cancer cells grow and divide. By attaching to~     the target, it may stop the cancer cells from further growth and dividing. This study will~     help find out if MK-0646 is a helpful drug when taken in patients with neuroendocrine tumor.~      This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects,~     good and/or bad, MK-0646 has on metastatic neuroendocrine tumors.~   "
225232|NCT00610116|"~     Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine,~     cumulative incidence of phrenic nerve stimulation (PNS) & success rates of ER to remove it,~     various incl. left ventricular pacing (LVP) thresholds and PNS~   "
225233|NCT00610103|"~     The purpose of this study is to evaluate the efficacy of KW-6500 versus placebo when~     administered as a subcutaneous injection at the individualized maintenance dose level in an~     OFF state in Parkinson's disease patients with motor response complications on levodopa~     therapy.~   "
225234|NCT00610090|"~     The primary study objective, at this time, is to follow out to 5 years post implant the~     safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac (AUI)~     Endoluminal Stent Graft (the study device) for the repair of abdominal aortic aneurysms~     (AAAs).~   "
225235|NCT00610077|"~     OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients~     with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group,~     multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in~     India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited.~     Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles)~     were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S):~     Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.~   "
225236|NCT00610064|"~     Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory~     lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence,~     non-obstructive chronic urinary retention and chronic pelvic pain syndrome. Modulation of~     central afferent activity is considered critical to this therapeutic effect but the neural~     mechanisms are poorly understood.~      We hypothesize that SNM has a significant effect on brain activity detectable by positron~     emission tomography (PET).~   "
225237|NCT00610051|"~     This is a multicenter, double blind, placebo-controlled, randomized, parallel group study~     that compares Alprostadil given in a low, fixed-dose continuous infusion and placebo. The~     difference between the two groups for the primary endpoints will be compared after 24 weeks~     (Outpatient Double-Blind Treatment Phase). Thereafter, patients will continue on blinded~     treatment and observation to all continued assessment of survival and cardiac-specific~     mortality (Follow-Up Phase). It is planned that approximately 550 patients with advanced~     heart failure be randomized (see Inclusion and Exclusion Criteria~   "
225238|NCT00610038|"~     The aim of our trial is to try to switch patients with permanent neonatal diabetes mellitus~     due to a Kir6.2 or SUR1 activating mutation from subcutaneous insulin to oral glibenclamide~     therapy.~   "
225239|NCT00610025|"~     During surgery for obesity, minimally invasive endoscopy can be performed and can assist the~     surgeon in determining surgical incision sites.~   "
225240|NCT00610012|"~     The purpose of this registry is to record information of therapy reality of metastatic or~     locally advanced Renal Cell Carcinoma by office-based medical oncologists in Germany.~   "
225241|NCT00609999|"~     Primary:~      To determine maximum tolerated dose & dose limiting toxicity of dasatinib when combined w~     erlotinib among pts w recurrent MG~      Secondary:~      To further evaluate safety & tolerability of dasatinib + erlotinib To evaluate~     pharmacokinetics of dasatinib when administered w erlotinib among recurrent MG pts who are on~     & not on CYP-3A enzyme inducing anti-epileptic drugs To evaluate for anti-tumor activity with~     this regimen in this patient population~   "
225322|NCT00608868|"~     The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a~     second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid~     Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type~     of tumor.~   "
225243|NCT00609973|"~     Despite extensive medical treatment, surgical resection is required in approximately 70% of~     the patients at some time. However, recurrence of the disease after operation occurs in the~     majority of patients and is a serious limitation of surgical management. Therapeutic options~     to maintain postoperative clinical remission are urgently needed. Several drugs including~     mesalazine, antibiotics (metronidazole, ornidazole) and azathioprine or 6-mercaptopurine have~     been studied in the past. But the efficacy is very limited (mesalazine), overshadowed by~     intolerability during long-term therapy (metronidazole, ornidazole) or inconclusive~     (azathioprine or 6-mercaptopurine). Research demonstrating the absence of inflammation in~     patients with diverting ileostomy and the clinical benefit of a postoperative antibiotic~     therapy using metronidazole or ornidazole implicates a role of the resident bacterial flora~     in the postoperative relapse. Ciprofloxacin has a broad antibacterial spectrum. More~     interestingly it also suppresses E. coli strains, which can be found in high numbers in early~     and chronic ileal lesions of Crohn's disease patients Ciprofloxacin has demonstrated~     beneficial effects in the therapy of inflammatory bowel diseases, but the available data of~     the effectiveness of ciprofloxacin allow only a very limited judgement of the safety and~     tolerability of a 6 months therapy of ciprofloxacin. Therefore an exploratory multicenter~     prospective, placebo-controlled trial is planned to analyze the safety and tolerability of a~     6 months therapy with ciprofloxacin compared to placebo in 40 patients (randomly assigned in~     a 1:1 ratio) undergoing ileocecal resection (or resection of parts of the colon). If this~     therapeutic regimen demonstrates tolerability, a second larger study improving the~     superiority of ciprofloxacin versus placebo can be initiated.~   "
225244|NCT00609960|"~     This study wants to test the hypothesis that trained clowns can reduce anxiety in children~     undergoing general anesthesia. We will compare the effect of the clowns to the commonly used~     anti-anxiety medication we commonly use~   "
225245|NCT00609947|"~     The objective of this study is to verify the safety and efficacy of the Endeavor~     Zotarolimus-Eluting Coronary Stent System for improving coronary luminal diameter in patients~     with ischemic heart disease due to de novo lesions of length ≤27 mm in native coronary~     arteries with reference vessels ≥ 2.25 mm to ≤ 2.75 mm.~   "
225246|NCT00609934|"~     The purpose of this study is to investigate the use of a new anti-angiogenic drug called~     sorafenib, in combination with radiotherapy, for renal cell cancer that has spread to the~     bone and is causing significant pain. The study will find a safe dose of sorafenib for this~     combination study treatment, look at side effects, and test if the study treatment is~     effective in controlling the pain experienced from this type of renal cell cancer. . There~     will be two parts or phases to this study~      The purpose of the first phase is to find the highest dose of sorafenib that can be given~     safely to patients, when combined with radiotherapy. We will also see what kind of effects~     the study treatment has on you and your cancer. Participants in this phase will receive a~     dose of sorafenib that has shown to be well-tolerated in humans. If the side effects are~     tolerable for this dose of sorafenib when combined with radiotherapy, new patients will be~     asked to join the study and will receive a dose of sorafenib higher than the last study~     participant.~      In the second phase, new study participants will receive the dose of sorafenib that was~     determined to be safe in the first phase. Side effects will continue to be looked at and the~     effectiveness on controlling pain symptoms from this type of cancer, will also be looked at.~   "
225247|NCT00609921|"~     This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with~     advanced/recurrent solid tumors. The purpose of this study is to determine the safety,~     tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.~   "
225248|NCT00609908|"~     Objective:~      A randomized controlled trial is performed to evaluate the clinical effectiveness of the skin~     stretching technique for two categories:~        1. acute burn wounds: wound closure by means of skin stretching should lead to a~          significant reduction of scar surface area in comparison to the standard technique, the~          split skin grafting;~        2. scar reconstructions: wound closure by means of skin stretching during one operative~          procedure should lead to a comparable scar surface in comparison to the multiple~          procedures techniques such as serial excision.~      Study design:~      Skin stretching will be compared to split skin grafting and should result in burn wound~     closure with significantly smaller scars. Also, a comparison will be made between the~     technique of serial excision versus skin stretching for scar reconstructions.~      Scar evaluation three and twelve months after surgery will include the following parameters:~        -  surface area;~        -  Patient and Observer Scar Assessment Scale (POSAS);~        -  elasticity;~        -  vascularization and pigmentation;~        -  thickness;~        -  dermal architecture.~      After 12 months adults will undergo a biopsy of the scar under local anesthesia. The~     experimental group, treated with the skin stretcher will undergo one extra biopsy of the~     formerly stretched skin.~      Intervention:~      At the start of the operation will be determined by randomization if skin stretching or split~     skin grafting (acute burn wounds) or serial excision (scar reconstruction category) will be~     performed.~   "
225249|NCT00609895|"~     To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at~     any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive~     days after switching insulin glargine dosing time from bedtime to morning and vs. 3~     consecutive days after switching back to bedtime dosing of insulin glargine.~   "
225250|NCT00609882|"~     We hypothesize that the success rate for keeping babies extubated (without a breathing tube~     for assisted mechanical ventilation), defined as the proportion of infants remaining~     extubated for a minimum of 72 hours, will be equivalent among infants managed with nasal CPAP~     compared to humidified high flow nasal cannula (HHFNC).~   "
225251|NCT00609869|"~     The purpose of this research is to evaluate the use of Rituximab in combination with Revlimid~     in the treatment of refractory Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia~     (CLL). Revlimid® is a drug that changes the immune system and it may also get in the way with~     the growth of tiny blood vessels that help support tumor growth. Therefore, in theory, it may~     reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug~     Administration (FDA) for the treatment of specific types of Myelodysplasia syndrome (MDS) and~     Multiple Myeloma, two different types of blood cancer. It is currently being tested in a~     variety of cancer conditions. In this case it is considered experimental.~   "
225252|NCT00609856|"~     Pioglitazone and insulin glargine are equally effective in achieving glycemic control in~     secondary drug failure of type 2 diabetes but the mechanisms of actions are different.~   "
225253|NCT00609843|"~     Rationale: Bladder tumours are often not visible on X-ray based image-modalities during~     planning and treatment of Radiotherapy.~      Purpose: To determine if a single contrast (Lipiodol) demarcation of the bladder tumour~     before treatment is feasible and visible on multiple X-ray based image-modalities during~     Radiotherapy.~   "
225327|NCT00608803|"~     The study of safety of ZIO-201-T in combination with doxorubicin in the treatment of advanced~     cancer.~   "
225254|NCT00609830|"~     The ultimate objective of the proposed research is to improve the health-related quality of~     life of individuals with rheumatoid arthritis by reducing their risk of developing~     osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.~      Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and~     behaviors with respect to osteoporosis and osteoporosis prevention.~      Specific Aim 2: To identify factors that discriminate among patients in different stages of~     change with respect to each behavior of interest.~      Specific Aim 3: To compare the effects of tailored versus generic educational materials on~     patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced~     Osteoporosis.~      Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by~     concurrent feedback of information concerning patients' behavioral risk factor status to~     their physicians.~   "
225255|NCT00609817|"~     A Phase 1, open-label, dose escalation, multi-center study in patients who have been~     diagnosed with multiple myeloma and who have relapsed or have refractory/relapsed disease~     after treatment with at least 2 prior therapies.~   "
225256|NCT00609804|"~     This is a randomized, open-label, multi-center, Phase II study of treatment of patients with~     advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and~     erlotinib or sorafenib alone.~   "
225257|NCT00609791|"~     RATIONALE: Gathering information from patients of different ages receiving paclitaxel~     albumin-stabilized nanoparticle formulation for metastatic breast cancer may help doctors~     understand how the age of the patient changes the way the drug works.~      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle~     formulation works in treating patients of different ages with metastatic breast cancer.~   "
225258|NCT00609778|"~     The primary objective is to show superiority in survival of the modified method with the~     LUCAS Chest Compression System, compared to the conventional manual resuscitation method in~     patients suffering from out of hospital sudden cardiac arrest.~   "
225259|NCT00609765|"~     Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and~     streptozocin administered in 28-day cycles. Treatment will continue until progression of~     disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In~     order to reduce the risk of cardiac toxicity, doxorubicin will be administered for a maximum~     of 8 cycles. If disease has not progressed after 12 cycles of treatment, avastin monotherapy~     will continue until disease progression or withdrawal due to toxicity.~   "
225260|NCT00609752|"~     This study will compare two current first-line treatments for childhood Crohn's Disease,~     steroids versus a liquid diet, and determine the effects of these treatments on bone health,~     quality of life and treatment efficacy.~   "
225261|NCT00609739|"~     RATIONALE: Giving chemotherapy drugs, such as cytarabine and mitoxantrone, before a donor~     stem cell transplant helps stop the growth of cancer cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When certain stem cells from a donor are~     infused into the patient they may help the patient's bone marrow make stem cells, red blood~     cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can~     make an immune response against the body's normal cells. Giving cyclosporine, methotrexate,~     and methylprednisolone before or after transplant may stop this from happening.~      PURPOSE: This phase I/II trial is studying the side effects and best way to give high-dose~     cytarabine together with mitoxantrone in treating patients with juvenile myelomonocytic~     leukemia undergoing a second donor stem cell transplant.~   "
225262|NCT00609726|"~     The purpose of the study is to determine the best evaluation for patients with idiopathic~     (unexplained) pancreatitis.~   "
225263|NCT00609713|"~     The long-term goal of this proposal is to understand the impact of obesity and obesity~     treatment on bone health during adolescence and how to preserve it. The recent pediatric~     obesity epidemic raises important clinical and public health questions about the effects of~     childhood-onset obesity and its treatment on bone health. Osteoporotic fractures are a major~     cause of morbidity and mortality in the aged, and peak bone mass (PBM), achieved shortly~     after puberty, is a key determinant of bone strength and lifetime fracture risk. Given the~     current obesity epidemic, obesity treatment during adolescence will continue to be necessary.~     The benefits of pediatric obesity treatment are unquestionable. However, the potential~     detrimental effects of weight loss on bone density and dimensions are not known in~     adolescents and are the focus of this proposal.~      This study will focus on the impact of pediatric-onset obesity and its treatment on bone~     health, using two approaches: comparing obese and non-obese adolescents and comparing obese~     adolescents before and after weight loss. We hypothesize that (a) compared to non-obese~     controls, obese adolescents have stronger bones, and that (b) bone strength of obese~     adolescents decreases during weight loss compared to usual care, which would suggest a need~     to promote bone health during successful weight loss in obese adolescents.~   "
225264|NCT00609700|"~     This observational study compares the influence of Ringer's Lactate solution and Ringer's~     Acetate solution on organ function scores following severe burn injury.~   "
225265|NCT00609687|"~     The usefulness of diagnostic vitrectomy in patients with suspected sarcoidosis with posterior~     segment involvement (in whom a diagnosis cannot be determined by conventional methods) has~     not been well described. We hypothesized that diagnostic vitrectomy would help establish the~     diagnosis in these challenging cases. Herein, we evaluated the diagnostic yield of vitreous~     biopsy in patients with suspected sarcoidosis-associated uveitis that affected the posterior~     segment.This is a retrospective interventional case series. Cases of intermediate, posterior~     or panuveitis that could not be characterized by clinical examination, ancillary, and~     laboratory tests were considered for diagnostic pars plana vitrectomy. Retrospective chart~     review was conducted on consecutive eyes that underwent diagnostic, or diagnostic and~     therapeutic vitrectomy by a single surgeon from January 1989 to June 2006.~   "
225266|NCT00609674|"~     The purpose of this study is to compare the effects (effectiveness and safety) of an~     intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]), with a placebo nasal~     spray for the treatment of perennial (year-round) allergic rhinitis.~   "
225304|NCT00609128|"~     The purpose of the research is to determine which inflammatory substances are involved in~     causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with~     symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances~     released by cells in the affected tissues cause allergic reactions in the eye and elsewhere~     in the body.~   "
225267|NCT00609661|"~     This study is designed to determine the response of adult stems cells, also referred to as~     mesenchymal stem cells (MSCs), to tissue injury resulting from thermal burns. The study will~     consist of a one time collection of a patient's blood, about one teaspoon, on the third day~     following the initial burn. MSCs in the blood will then be quantitated and identified using~     according to unique proteins found on their cell surface using flow cytometry. The results of~     flow cytometry analysis will then be compared to the patients characteristics (age, sex,~     race, etc.), their past medical history (hx of diabetes, hypertension, heart disease, etc.)~     and to the patient outcome (length of hospital stay, mortality, etc.).~   "
225268|NCT00609648|"~     This is a randomized study in which two groups will be used to compare the effectiveness of a~     computerized psychological therapy compared to an information only control group (pamphlet)~     for reducing fear of dental injections.~   "
225269|NCT00609635|"~     This research study involves studying the genes that may affect how ill you become during~     respiratory infection with respiratory syncytial virus (RSV). RSV is a virus that often~     causes common colds.~      Cytokines are chemicals that are naturally made by your body. Cytokine levels are increased~     in some people when they have common colds or wheezing caused by respiratory syncytial virus~     (RSV). The purpose of this study is to study the genes that may control cytokine levels~     during infection with RSV in the elderly population.~   "
225270|NCT00609622|"~     This study will compare the safety and efficacy of sunitinib in combination with FOLFOX~     versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic~     colorectal cancer who have not been treated before.~   "
225271|NCT00609609|"~     The goal of this clinical research study is to find out whether adding extracorporeal~     photopheresis (ECP) to standard therapy for acute GVHD with corticosteroids improves response~     to treatment, length of treatment, and survival.~   "
225272|NCT00609596|"~     Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when~     given together, there is more improvement in symptoms than either drug alone. In this study,~     we are looking to see if 2 different formulations of tamsulosin in our combination capsules~     are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.~   "
225273|NCT00609570|"~     Three different supplements will be used in the study (fruits and vegetable powders, whey~     protein and calcium) for patients with hypertension. The null hypothesis was that the~     supplements had no effects on participants' blood pressure.~   "
225274|NCT00609557|"~     This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may~     receive duloxetine or placebo during the course of the trial. All subjects will, in fact,~     receive placebo for the first two weeks. All subjects will then be placed on 60-90mg per day~     of duloxetine. Primary outcome assessment will compare pain intensity at 2 weeks (after~     placebo) to that at 12 weeks (after 10 weeks of duloxetine treatment).~      Study Hypothesis:~      In subjects who continue to have activity-limiting osteoarthritis pain after treatment with~     acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day over 10~     weeks will provide significant additional pain relief over that achieved with placebo(> 30%~     reduction after Duloxetine treatment).~   "
225275|NCT00609544|"~     Anemia of inflammation is a common complication in patients with chronic kidney disease~     (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to~     erythropoietic agents, even in the presence of adequate iron stores. This decreased~     responsiveness is associated with increased levels of proinflammatory cytokines. Rilonacept~     is being developed for the treatment of inflammatory disorders.~      This is a clinical research study to determine the safety and effectiveness of rilonacept for~     the treatment of anemia in inflamed patients with CKD who are not yet on dialysis.~   "
225276|NCT00609531|"~     The purpose of this proof of concept study is to use functional magnetic resonance imaging~     and behavioral assessments to investigate the effect of citalopram on restricted repetitive~     behaviors in people with autism spectrum disorders.~   "
225277|NCT00609518|"~     Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given~     folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side~     effects associated with pemetrexed. The aim is whether it is possible to simplify the folic~     acid and steroid schedule without increasing toxicity.~   "
225278|NCT00609505|"~     Cancer genetic counseling (CGC) has been found to have substantial benefits for individuals~     with breast cancer and their family members; it has been deemed by multiple organizations as~     standard of care for women with breast cancer and their relatives. Unfortunately, there is~     a disparity in access to CGC, especially among women who live in rural and underserved areas.~     In North Carolina, only two cancer genetic counselors practice in rural clinics - each only~     for a few days per month. Therefore, in an effort to make CGC more widely available in a~     timely manner, we propose to test provision of counseling through telemedicine (TM), in which~     a patient and health care provider communicate with each other using videoconferencing. In 4~     rural oncology clinics, we will implement low-cost TM and compare satisfaction and~     cost-effectiveness between groups of women designated to have their CGC session by TM or FTF.~     We'll use a validated measure to assess satisfaction by a phone survey one week after the CGC~     appointment; cost-effectiveness will be measured at project's end by calculating length of~     wait time for appointment and costs of equipment, labor, and mileage. Study hypothesis: TM is~     as satisfactory as FTF counseling and is a more cost-effective way to provide this beneficial~     service.~   "
225279|NCT00609492|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a~     booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine~     co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born~     children at the age of 16-18 months. This protocol posting deals with objectives & outcome~     measures of the booster phase. The objectives & outcome measures of the primary phase are~     presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating~     in this study should have received three doses of pneumococcal vaccine in the primary study.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
225280|NCT00609479|"~     The purpose of this study is to compare two different fixationmethods for fractures of the~     wrist(distal radius fractures). We are comparing an external fixation~     (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient~     satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength,~     PRWE-questionnaire.~   "
225281|NCT00609466|"~     The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose~     application of oral application of CG5503 IR 75mg compared to placebo and to assess safety~     and tolerability of CG5503 IR 75mg in subjects following bunionectomy.~      This trial was performed based on a previously performed double-blind, placebo-controlled,~     multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75~     and 100 mg) published under PMID: 18851776.~   "
225282|NCT00609453|"~     The goal of the proposed research is to examine the neural correlates of depressive symptom~     reduction in individuals with major depressive disorder using functional magnetic resonance~     imaging (fMRI), and to compare results to those obtained from a nondepressed control group.~   "
225283|NCT00609440|"~     OBJECTIVES: Relating about the benefits proportionated by the physiotherapeutic treatment for~     the patients that have the Morquio's syndrome. METHODS: This study intends to analyse a~     patient that presents this syndrome, describing the physiotherapeutic treatment that was~     proposed and the evolution clinical.~   "
225284|NCT00609427|"~     The purpose of this study is to evaluate the effects of training in memory skills vs. use of~     external memory aids on everyday memory functioning in older people with mild cognitive~     impairment.~   "
225285|NCT00609414|"~     This is a study of why and how physicians use albumin during the first 72 hours after a burn~     injury.~   "
225286|NCT00609401|"~     The ROSORC trial is a randomized study comparing the efficacy of a new association (sorafenib~     and IL-2) versus the standard therapy (sorafenib) in patients affected by different~     histotypes of metastatic RCC. This study is a first line therapy for the advanced disease.~     The primary objective is the progression free survival (PFS) in the 2 arms of therapy and the~     secondary objective is the overall survival (OS) and the response rate (RR) and the safety~     profile of the combination compared to sorafenib alone.~   "
225287|NCT00609388|"~     The evaluation of the efficacy of an intraportal infusion with Tacrolimus, at the time of~     liver graft implantation, compared to a control group without immunosuppressive intraportal~     infusion (Placebo: Saline solution 0.9%) with respect to the initial liver function measured~     by the parameters of the liver function (LFP): AST (U/L), ALT (U/L), total Bilirubin (mg/dL)~     and the coagulation factors: NT (%), PTT (s), INR.~   "
225288|NCT00609375|"~     To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous~     infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in~     Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate~     of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and~     rates of relapse after 28 days.~      Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or~     microbiological cure greater than the intermittent administration.~   "
225289|NCT00609362|"~     Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The~     disease is caused partly by environmental and partly by genetic factors. It is well known~     that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies~     suggest that stimulation of bone marrow stem cells through the molecule PPARgamma with the~     drug rosiglitazone converts the stem cells to fat cells instead of bone cells thereby~     decreasing bone strength. In a single study healthy volunteers were treated with~     rosiglitazone for 14 weeks and had a decrease in bone mineral density.~      In the present study we wish to investigate the effect of this treatment on bone and fat~     tissue. 25 women above the age of 60 will be treated with rosiglitazone 8 mg/day for 14 weeks~     and compared with 25 women receiving placebo.~      The effect will be evaluated as follows:~        1. The effect on bone marrow density will be examined by a bone scan prior to and after~          treatment and again after 6 and 9 months.~        2. The effect on bone turnover will be measured in blood- and urine samples at the same~          times.~        3. The effect on fat distribution will be evaluated by an MRI scan after treatment.~        4. The effect on bone marrow cells will be investigated bone marrow sampling immediately~          after treatment~        5. The direct effect on fat will be examined by a biopsy immediately after treatment The~          study hypothesis is that rosiglitazone treatment decreases bone mineral density and~          increases bone marrow fat content. The causal molecular mechanisms will be investigated~          from the bone marrow and fat samples~   "
225290|NCT00609349|"~     The early detection of pulmonary arterial hypertension may help to improve prognosis of the~     disease. It is assumed that in the early stages of pulmonary arterial hypertension, pulmonary~     arterial pressure values may be normal at rest, but the remodelling of small arteries leads~     to stiffening resulting in increased pulmonary arterial pressure during exercise. In the~     present study we investigate patients with risk factors for pulmonary arterial hypertension~     (e.g. connective tissue disease) by combining exercise tricuspid echo doppler and~     cardiopulmonary exercise test to screen patients for exercise-induced pulmonary hypertension~     and control the results by the gold standard right heart catheterisation at rest and during~     exercise. We expect that using this screening method, patients with pulmonary arterial~     hypertension would be recognized earlier.~   "
225291|NCT00609336|"~     This phase II trial studies how well giving combination chemotherapy together with~     intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with~     localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such~     as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor~     may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug~     (combination chemotherapy) together with intensity-modulated radiation therapy before surgery~     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~     Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.~   "
225303|NCT00609141|"~     This phase I clinical trial is studying the side effects and best dose of IMC-A12 in treating~     young patients with relapsed or refractory Ewing sarcoma/peripheral primitive neuroectodermal~     tumor or other solid tumors. Monoclonal antibodies, such as IMC-A12, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them.~   "
244610|NCT00352248|"~     We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.~   "
225292|NCT00609323|"~     Pliaglis™ (lidocaine and tetracaine) Cream 7%/7% is a topical local anesthetic cream that~     forms a pliable peel on the skin when exposed to air. When applied to intact skin, Pliaglis~     provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into~     the skin.~      Pliaglis is currently approved in the United States for use on intact skin in adults to~     provide topical local analgesia for superficial dermatological procedures such as dermal~     filler injection, pulsed dye laser therapy, and facial laser resurfacing.~      This study will evaluate lidocaine and tetracaine cream 7%/7% for the treatment of pain~     associated with postherpetic neuralgia (PHN).~   "
225293|NCT00609310|"~     Prove the hypothesis that dietary supplementation with bioflavonoids will diminish the~     recurrence rate of colonic neoplasia, we will implement a clinical trial comparing~     bioflavonoids and placebo in a double blind randomized clinical trial. To use a standardised~     supplementation of bioflavonoids, a commercially available preparation (Flavo-Natin®) will be~     used.~   "
225294|NCT00609297|"~     RATIONALE: Gathering information over time about cancer-related pain from patients in a~     hospice and their caregivers may help doctors learn more about pain control.~      PURPOSE: This clinical trial is studying how well standard pain control works in hospice~     patients with cancer-related pain.~   "
225295|NCT00609284|"~     The aim of the trial is to study the efficacy of adding concomitant chemotherapy~     (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck~     cancer.~   "
225296|NCT00609271|"~     The objective of this trial is to examine the long-term effects of a diet low in~     carbohydrates, as compared to one low in fat, on cardiovascular disease risk factors,~     including blood pressure (BP), body weight and composition, serum lipids, plasma glucose,~     insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among~     obese adults.~      The investigators will test the following hypotheses:~      Hypothesis 1: Compared to a low fat diet, a diet low in carbohydrates will reduce systolic~     and diastolic BP over 12 months; Hypothesis 2: Compared to a low fat diet, a diet low in~     carbohydrates will reduce body weight, total percent body fat, and waist circumference over~     12 months; Hypothesis 3: Compared to a low fat diet, a diet low in carbohydrates will reduce~     serum levels of LDL-cholesterol and triglycerides and increase serum levels of~     HDL-cholesterol over 12 months; Hypothesis 4: Compared to a low fat diet, a diet low in~     carbohydrates will reduce plasma levels of glucose and insulin levels over 12 months; and~     Hypothesis 5: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma~     levels of leptin, resistin, and CRP and increase plasma levels of adiponectin over 12 months.~   "
225297|NCT00609245|"~     We are trying to learn if small changes in the amount of a valproate in the blood (given~     through an IV) will change the way the brain reacts to flashing lights.~   "
225298|NCT00609219|"~     Patients have a type of cancer called nasopharyngeal cancer. This cancer has come back or not~     gone away or is at high risk for coming back after treatment (including the best treatment we~     know for nasopharyngeal cancer). We are asking patients to volunteer to be in a research~     study using special immune system cells called EBV-specific cytotoxic T lymphocytes, a new~     experimental therapy.~      Most patients with nasopharyngeal cancer show evidence of infection with the virus that~     causes infectious mononucleosis, Epstein Barr virus (EBV), before or at the time of their~     diagnosis of nasopharyngeal cancer. EBV is found in the cancer cells of most patients with~     nasopharyngeal cancer, suggesting that it may play a role in causing this cancer. The cancer~     cells infected by EBV are able to hide from the body's immune system and escape destruction.~     We want to see if special white blood cells (called T cells) that have been trained to kill~     EBV-infected cells can survive in the patient's blood and affect the tumor.~      We have treated other patients with different EBV positive cancers and have had variable~     results. Some patients have had some response to the treatment. Some patients have been cured~     by the treatment. It is not possible for us to predict if this treatment will work for~     nasopharyngeal cancer.~      The purposes of this study are to find the largest safe dose of EBV specific cytotoxic T~     cells, to learn what the side effects are, and to see whether this therapy might help~     patients with nasopharyngeal cancer.~   "
225299|NCT00609193|"~     The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain~     structure, function and chemistry in people with bipolar disorder who are being treated with~     either quetiapine or lithium. Both of these medicines are FDA-approved to treat mania in~     adults and lithium is also FDA approved in children; quetiapine is commonly used in children~     with mania, but is not FDA approved for this indication in this age group.~   "
225300|NCT00609180|"~     Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions~     that occur when there is severe inflammation and increased fluids in both lungs, making it~     difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS~     often includes the use of a breathing machine, or ventilator, until the person is able to~     breathe without assistance. Initiating proper nutrition through a feeding tube early in a~     person's hospital stay may help to improve recovery, but the optimal timing, composition, and~     amount of feeding treatments are unknown. This study will evaluate whether early or delayed~     full-calorie feeding through a feeding tube is more effective in reducing recovery time and~     increasing survival rates in people with ALI/ARDS. The study will also determine whether~     supplementing the feedings with omega-3 fatty acids and antioxidants benefits people with~     ALI/ARDS.~   "
225301|NCT00609167|"~     RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving cyclophosphamide and dexamethasone together with~     bortezomib may kill more cancer cells.~      PURPOSE: This phase II trial is studying giving cyclophosphamide and dexamethasone together~     with bortezomib to see how well it works in treating patients with newly diagnosed multiple~     myeloma.~   "
225302|NCT00609154|"~     The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on~     maintaining the function and health of the insulin producing beta cells. This hormone is~     known to increase the production rate of new insulin as well as increase the release of~     insulin into the blood. We will measure the rate of new insulin production in subjects with~     Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2~     diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.~   "
225305|NCT00609115|"~     The AMES device is designed to produce functional cortical changes by:(1) assisting the~     subject as he/she attempts to move the limb (assisted movement) and (2) enhancing movement~     sensation by vibrating the muscles during movement (enhanced sensation). The primary~     hypothesis is that the combination of assisted movement and enhanced sensation from muscle~     vibration can increase the amount of motor recovery in individuals disabled by a stroke.~   "
225306|NCT00609102|"~     This study examines whether an antioxidant taken orally will improve glucose tolerance and~     insulin secretion in type 2 diabetic subjects.~   "
225307|NCT00609089|"~     The planned research will adapt an intervention of known efficacy to target a new outcome of~     significant importance to public health. Specifically the Community Reinforcement and Family~     Training (CRAFT) procedures will be adapted, from reinforcing treatment entry, to reinforcing~     treatment retention and HIV risk behavior reduction in persons with opioid dependence who~     receive a Buprenorphine taper detoxification. The research plan includes three phases: 1)~     development of a manual guided therapy, 2) development of therapist training and fidelity~     measures and 3) a randomized pilot evaluation with 52 patients receiving either the new CRAFT~     treatment or treatment as usual.~   "
225308|NCT00609063|"~     Statins are a group of medications that are used to lower cholesterol levels. Although~     serious side effects are rare, some people taking statins experience muscle pain or weakness.~     This study will evaluate the number of people who experience mild muscle complaints and will~     determine the effect of statins on skeletal muscle strength, endurance, and aerobic exercise~     performance.~   "
225309|NCT00609050|"~     The aim of this study is to test the effect of a 6-month program of self-regulated,~     home-based exercise with telephone reinforcement on the cardiorespiratory fitness, pulmonary~     function and health-related quality of life of children with cystic fibrosis (CF), compared~     to controls. Exploring the exercise experiences of the children and parents is a secondary~     aim.~   "
225310|NCT00609037|"~     The primary aim of our study is to test the hypothesis that wound healing is impaired in the~     patient who has experienced massive weight reduction following gastric bypass for morbid~     obesity. Specifically we will document post-surgical local complications and evaluate~     multiple wound healing parameters in two patient populations in a prospective fashion. The~     test group will consist of patients who have undergone dramatic weight loss and are much in~     need of a panniculectomy due to excessive skin redundancy. The control group will consist of~     patients within normal weight ranges who are seeking an abdominoplasty.~   "
225311|NCT00609011|"~     This is an open-label, dose finding, multiple-dose study in subjects with metastatic~     melanoma. Three dose levels of MPC-6827 will be administered with temozolomide to three~     separate cohorts. Study endpoints will include determination of the maximum tolerated dose,~     determination of dose limiting toxicities, and evaluation of evidence of anti-tumor activity~     of MPC-6827 when given with temozolomide.~   "
225312|NCT00608998|"~     The aim of this study is to appreciate the influence of renal failure progression on~     vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular~     risk factors.~   "
225313|NCT00608985|"~     A polysomnography study to evaluate the effect, safety and tolerability of oral~     administration of almorexant (ACT 078573) in adult subjects with primary insomnia.~   "
225314|NCT00608972|"~     The purpose of this research study is to look at the effectiveness of a combination of doxil,~     carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being~     studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and~     progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on~     both cancer and normal cells. This family of receptors is important for cell growth and is~     found in many tumor types.This study is being conducted for the following research purposes:·~     To find out what effects, if any, the study drug has on metastatic breast cancer. For~     instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the~     safety of the study drugs and to see what affects it has. For instance, are there any side~     effects? If so, what kind of side effects does the study drug cause? How severe are the side~     effects, and how often do they occur?· To see if the study drugs have any effect on keeping~     the disease from getting worse.~   "
225315|NCT00608959|"~     The purpose of this research study is to determine if omiganan 1% gel (the investigational~     medication in this research study) is effective and safe when compared to chlorhexidine 2%~     (an FDA approved medication) for killing bacteria (germs) that live on the surface of the~     skin. Both of the study medications are applied topically (on the surface of the skin).~   "
225316|NCT00608946|"~     The efficacy of 8 mg of copper daily regarding cognitive function, content of beta amyloid~     protein in the CSF and volumetric changes in the brain will be examined in a first~     double-blind, placebo-controlled human clinical trial conducted in 70 patients with mild~     Alzheimer´s dementia.~   "
225317|NCT00608933|"~     RATIONALE: Educating health providers on talking with cancer patients about complementary and~     alternative medicine (CAM) may help encourage health providers to talk more often with cancer~     patients about the use of CAM.~      PURPOSE: This randomized phase III trial is studying how well an education intervention works~     in encouraging health providers to talk with cancer patients about the use of CAM.~   "
225318|NCT00608920|"~     The purpose of this study is to determine if the planning of radiation treatment of prostate~     cancer patient can be made more precise by comparing currently planning techniques to an~     imaging technique called SPECT.~   "
225319|NCT00608907|"~     The primary purpose of this Phase I study is to evaluate the effect of the co-administration~     of CYP3A4 inducers on the pharmacokinetics profile of VELCADE (bortezomib). Rifampicin will~     be used to assess the effect of a strong CYP3A4 inducer and dexamethasone to assess the~     effect of a relatively weak inducer. This study is also to evaluate the impact of CYP3A4~     inducers on the pharmacodynamics (PD) of VELCADE and the safety profile of VELCADE.~   "
225320|NCT00608894|"~     An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety~     and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination~     with prednisone, for the treatment of autoimmune hepatitis (AIH).~   "
225321|NCT00608881|"~     The goals of this trial are to determine if coenzyme Q10 is effective in slowing the~     worsening symptoms of Huntington's disease and to learn about the safety and acceptability of~     long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.~   "
225328|NCT00608790|"~     The purpose of this study is to test whether a saline nebulization (breathing in a mist of~     moist air through a mask) will help an individual cough up a better sputum sample to test for~     tuberculosis (TB). In addition, this study will test whether samples obtained with saline~     nebulization are better at finding TB in people with HIV infection. The study will enroll up~     to 600 individuals, aged 12 and older, with suspected pulmonary TB. Participants will be~     asked to cough up a sample of sputum into a container. Then, participants will be asked to~     breathe a mist of moist air from an oxygen mask followed by moist salty air, which will help~     individuals to cough up a second sputum sample. This mist of moist air will contain~     salbutamol, a medicine to help open up the airways. The sputum samples will be sent to a~     laboratory to test for TB. Additionally, participants will be tested for HIV with a blood~     sample collection. Participants will be involved in study related procedures for up to 61~     days.~   "
225329|NCT00608777|"~     The purpose of this study is to determine if calcipotriene/bethamethasone can safely and~     effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving~     efalizumab (Raptiva) for moderate to severe plaque psoriasis.~      It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB~     and thus allow patients to continue efalizumab without interruption.~   "
225330|NCT00608764|"~     Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is often caused~     by cigarette smoking. The purpose of this study is to evaluate whether certain genetic~     factors predispose some smokers to develop COPD more than others.~   "
225331|NCT00608751|"~     Patients with head and neck cancer and are schedule to receive standard radiation therapy~     known as IMRT to treat cancer~   "
225332|NCT00608738|"~     RATIONALE: Gathering information about patients with cancer and cancer-related conditions may~     help doctors learn more about a patient's needs and help doctors plan the best treatment.~      PURPOSE: This clinical trial is studying how well a whole-person-care guide works in~     identifying patient needs in patients with cancer or complications from cancer treatment.~   "
225333|NCT00608725|"~     The purpose of this study is to describe the mechanism of orthostatic intolerance, relying on~     cardiovascular physiological studies. The syndrome is of undetermined etiology, but the~     syndrome causes impairment of a number of young adults, females more than males, with~     symptoms of tachycardia, fatigue, lightheadedness, palpitations, blurred vision, chest~     discomfort, difficulty concentrating, and dizziness with the upright posture. It is believed~     that many different pathophysiological processes can give rise to this disorder.~   "
225334|NCT00608712|"~     Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational~     arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery~     for body weight reduction~   "
225335|NCT00608699|"~     To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin~     are co-administered as single doses to HVTs.~   "
225336|NCT00608686|"~     1. The major aims are to assess: (1) the relationship of basal and alcohol-induced~     neurosteroid and GABA levels to the degree of acute alcohol intoxication in healthy male and~     female volunteers; and (2) the effect of acute pregnenolone administration on the degree of~     acute alcohol intoxication in these same volunteers. Specific hypotheses are:~        -  Baseline serum levels of pregnenolone, pregnenolone sulfate (PS), dehydroepiandrosterone~          (DHEA) and DHEA sulfate (DHEA-S) will be inversely correlated with the magnitude of~          acute behavioral responses to alcohol (sedation, anxiolysis, amnesia, psychomotor~          impairment and intoxication). That is, higher baseline levels of these neurosteroids~          will be associated with lessened behavioral responses to alcohol.~        -  Baseline serum levels of allopregnanolone, tetrahydrodeoxycorticosterone (THDOC),~          androstanediol, androsterone and GABA will be directly correlated with the magnitude of~          acute behavioral responses to alcohol. That is, higher baseline levels of these~          substances will be associated with heightened behavioral responses to alcohol.~        -  Acute alcohol ingestion, compared to placebo ingestion, will increase serum levels of~          allopregnanolone and THDOC and plasma levels of GABA and will decrease plasma levels of~          PS. (Effects on levels of other neurosteroids are not specifically predicted based on~          animal data but will be examined in an exploratory manner.)~        -  Acute alcohol-induced increases in serum levels of allopregnanolone and THDOC and in~          plasma levels of GABA will be directly correlated with the magnitude of acute behavioral~          responses to alcohol. Acute alcohol-induced decreases in serum levels of PS will be~          directly correlated with the magnitude of acute behavioral responses to alcohol.~          Correlations between alcohol-induced changes in other neurosteroids and changes in~          behavior are not specifically predicted but will be examined in an exploratory manner.~        -  Pregnenolone, compared to placebo, pre-treatment will antagonize the acute effects of~          alcohol on the behavioral measures.~   "
225337|NCT00608673|"~     Discoid lupus erythematosus lesions are commonly treated with corticosteroids, but~     corticosteroids may induce side effects such as thinning of the skin or scarring. Therefore,~     an alternative medication with the same efficacy, but without the side-effects is sought~     after.~      Pimecrolimus is a newer drug specially designed to treat inflammatory diseases of skin. Its~     efficacy in treating discoid lupus erythematosus has not been studied extensively yet.~     However studies performed till now show promising results. Long-term topical use of this~     medication has not shown any serious side-effects in other skin diseases.~      In this study we aimed at comparing pimecrolimus efficacy with that of a common therapeutic~     choice, betamethasone valerate 0.1% cream, to see if pimecrolimus can be used as an~     alternative medication in treating discoid lupus erythematosus.~   "
225338|NCT00608660|"~     The purpose of this trial will certify the efficacy of using staging acupuncture and~     moxibustion to treat Bell's Palsy~   "
225339|NCT00608634|"~     RATIONALE: Drugs used in chemotherapy, such as perillyl alcohol, work in different ways to~     stop the growth of abnormal cells, either by killing the cells or by stopping them from~     dividing. It is not yet known which dose of topical perillyl alcohol is more effective in~     stopping the development of cancer in sun damaged skin.~      PURPOSE: This randomized phase II trial is studying high-dose topical perillyl alcohol to see~     how well it works compared with low-dose topical perillyl alcohol in treating patients with~     sun damaged skin and actinic keratoses.~   "
225340|NCT00608621|"~     The study is to evaluate the influence of physostigmine in the postoperative period in~     intensive care patients considering pain quality, opioid consumption, hemodynamics and~     mobilisation.~   "
225341|NCT00608595|"~     RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the~     laboratory may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond~     to treatment with celecoxib.~      PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with~     early-stage rectal cancer.~   "
225375|NCT00608062|"~     The purpose of this study is to find out why women's arteries stiffen as they go through~     menopause, and how this is affected by estrogen loss. We believe that arteries stiffen with~     the loss of estrogen because of oxidative stress, the production of molecules that can~     damage cells and tissues in the body, and because the arteries lose their ability to expand,~     or dilate.~   "
225920|NCT00600782|"~     This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB~     vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The~     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
225342|NCT00608582|"~     The purpose of this study is to examine whether repetitive transcranial magnetic stimulation~     (rTMS) can be used to improve speech in chronic stroke patients with aphasia. Aphasia~     patients can have problems with speech production. The rTMS procedure allows painless,~     noninvasive stimulation of human cortex from outside the head.~      Chronic aphasia patients have been observed in our functional magnetic resonance brain~     imaging studies to have excess brain activation in brain areas possibly related to language~     on the right side of the brain (opposite side to where the stroke took place). It is expected~     that suppression of activity in the directly targeted brain region will have an overall~     modulating effect on the neural network for naming (and propositional speech) and will result~     in behavioral improvement.~   "
225343|NCT00608569|"~     Highly active antiretroviral therapy (HAART) has led to better health and survival rates~     among people with HIV/AIDS. The purpose of this study was to measure the effect of trained~     partner supervision when taking medication versus self-administered therapy in HIV infected~     participants. These participants have had their first virologic failure on a non-nucleoside~     reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease~     inhibitor (PI)-based HAART regimen at study entry.~   "
225344|NCT00608556|"~     This study will examine genetic material obtained from blood and tissue samples of patients~     with congenital heart disease (CHD) and heterotaxy (an abnormality in the left-right~     positioning of organs in the body, also called situs inversus) to gain a better understanding~     of these disorders and of a lung disease called primary ciliary dyskinesia (PCD). CHD is~     prevalent in patients with heterotaxy. It is believed that certain forms of CHD or heterotaxy~     may have the same genetic origin as PCD.~      Individuals 2 years of age or older who have a CHD or heterotaxy or both may be eligible for~     this study. Participants undergo some or all of the following tests and procedures:~        -  Blood tests, electrocardiogram (EGC) and chest x-ray.~        -  Saliva collection: Subjects rinse their mouth with water, and then spit approximately~          1.5 cc of saliva into a sterile container.~        -  Buccal swabs: A small soft, toothbrush-like swab is rubbed on the inside lining of the~          cheek to collect tissue samples.~        -  Nasal tests to measure nasal nitric oxide levels and to obtain tissue samples from the~          inside of the nostrils: For the nitric oxide level test, a rubber probe is inserted into~          one of the nostrils until it fits snugly and comfortably. The subject then takes a deep~          breath and then exhales all the way out through the mouth through a plastic device.~          During exhalation, gas measurements are recorded on a computer. To obtain tissue~          samples, a device is inserted in a nostril and scraped gently against the inside of the~          nose.~        -  Echocardiography: This ultrasound test of the heart uses sound waves to obtain pictures~          of the heart. A small wand with a warm clear gel is moved around the chest to obtain the~          images.~        -  Abdominal ultrasound: This ultrasound test of the heart uses sound waves to obtain~          pictures of the abdominal organs. A small wand with a warm clear gel is moved around the~          abdomen to obtain the images....~   "
225345|NCT00608543|"~     Our target population will have been adequately treated with one of three selective serotonin~     reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks~     and continue to experience symptoms of depression that have prompted them to seek additional~     treatment. Escitalopram, citalopram, and sertraline were selected for use in this study~     because they are among the most commonly selected SSRIs and they are associated with a~     reduced likelihood of drug-drug interactions with aripiprazole. After completion of the~     screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15~     mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician,~     in conjunction with study participation. Symptom severity will be assessed on a weekly basis,~     and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We~     hypothesize that aripiprazole augmentation will be associated with reductions in symptom~     severity, and with improved performance on measures of psychosocial and cognitive function.~   "
225346|NCT00608530|"~     Two separate double double blind, randomized, parallel groups, two-arm, 8 week clinical~     trials with 6-moth follow-up were conducted using identical inclusion/exclusion criteria and~     assessment batteries. In both studies patients had chronic low back pain of non-neoplastic~     origin. In both studies patients were randomized to one of two conditions, either a Cognitive~     Behavioral-based Therapy or a control condition, a supportive (Rogerian) psychotherapy. Both~     the cognitive-behavioral and supportive psychotherapy conditions consisted of home-based,~     telephone supported treatment, with 10 hours of contact time delivered over 8 weeks. In the~     first study (Study 1) the behavioral and Rogerian interventions were delivered by a licensed~     psychologist. In the second (Study 2) the interventions were delivered by a medical primary~     care nurse.~   "
225347|NCT00608517|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood~     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor~     can make an immune response against the body's normal cells. Giving tacrolimus and~     mycophenolate mofetil before and after transplant may stop this from happening.~      PURPOSE: To look at the ability of umbilical cord blood cells from one or two unrelated~     donors to serve as a source of stem cells for people needing a bone marrow transplant.~   "
225348|NCT00608504|"~     The purpose is to study how certain factors, including money, the amount of drug available~     and the amount of work effort, affect opiate drug choice.~   "
225349|NCT00608491|"~     Heart failure is a serious condition in which the heart's ability to pump blood through the~     body is impaired, often making a person feel weak or fatigued. When a person's condition~     worsens to the point of hospitalization, that person is said to have acute decompensated~     heart failure (ADHF). Abnormal kidney function in association with cardiac distress, known as~     cardiorenal syndrome, is a common complication of heart failure and causes further medical~     problems and need for hospitalization. While there are various effective treatments for heart~     failure, more research is needed to determine the best treatment for targeting both ADHF and~     cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration~     versus standard medical drug therapy in improving renal function and relieving fluid buildup~     in people hospitalized with ADHF and cardiorenal syndrome.~   "
225350|NCT00608465|"~     The combination of high blood pressure and having central obesity is an increasing important~     factor for heart disease in men and women. It can also lead to the early development of~     hardening of the arteries and increased risk of a stroke. This study will analyze patients'~     genetic make up to identify who may be at greater risk for heart disease and strokes in~     relationship to high blood pressure and central obesity.~   "
225420|NCT00607464|"~     Does polyethylene occlusive wrap applied immediately after delivery to infants born at less~     than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the~     standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying~     under radiant heat)?~   "
225351|NCT00608452|"~     You may have a type of cancer associated with antineuronal antibodies in your blood.~      Antibodies are substances made by the immune system. They are used by the body to fight~     infections and other diseases. Antineuronal antibodies are antibodies that react with nerve~     cells but they also react with some tumors. We believe that the immune system makes these~     antibodies to fight the cancer. In some patients with these antibodies, the tumor is smaller~     than in patients who have no antibodies. Sometimes, with a very strong antibody test,~     patients may develop neurologic problems such as weakness, numbness or memory loss. One~     purpose of this study is to determine if a patient with cancer and a positive antineuronal~     antibody blood test has a smaller tumor and responds better to treatment than a patient with~     cancer and a negative test. Another purpose of this study is to determine whether patients~     with a positive antibody test develop neurologic problems such as weakness, numbness or~     memory loss.~      We will measure your blood for several different kinds of antibodies in addition to~     antineuronal antibodies to determine if the presence of antibodies predicts prognosis, i.e.~     smaller tumor and better response to treatment, or predicts the development of neurologic~     problems.~      No tissue samples are required for this study. However, if tissue or sputum is obtained by~     your oncologist for diagnostic purposes, we will ask your doctors or the pathology department~     to provide us with samples of these specimens. This will not involve any additional surgery~     or discomfort to you.~   "
225352|NCT00608439|"~     The purpose of this protocol is to investigate the safety, tolerability and effectiveness of~     CAST as a treatment for diabetic neuropathy. The primary outcome measure will be Total~     Neuropathic Symptom Score. Secondary outcomes will be neurological disability score, nerve~     conduction measurements and quantitative sensory testing. Statistical analyses will compare~     changes from baseline for CAST- and placebo-treated groups at both time points, compare~     effects of CAST at 6 and 12 months and, if numbers permit, compare doses.~   "
225353|NCT00608426|"~     Tobacco use is the leading cause of premature death in the United States and~     disproportionately affects Veterans and certain racial/ethnic minority groups. Most smokers~     are interested in quitting; however, current tobacco use treatment approaches are reactive~     and require smokers to initiate treatment or depend on the provider to initiate smoking~     cessation care. As a result, most smokers do not receive comprehensive, evidence-based~     treatment for tobacco use that includes intensive behavioral counseling along with~     pharmacotherapy. Proactive tobacco treatment integrates population-based treatment (i.e.,~     proactive outreach) and individual-level treatment (i.e., smoking cessation counseling and~     pharmacotherapy) to address both patient and provider barriers to comprehensive care.~   "
225354|NCT00608400|"~     The parathyroid gland and its hormone have a major impact on the endocrine control of bone~     metabolism and mineralization and parathyroid hormone (PTH) has been identified in some~     epidemiological reports to relate adversely to mortality. Previously, the applicant has~     demonstrated in two models that dietary cis-9, trans-11 conjugated linoleic acid (CLA)~     reduces PTH by over 30% in as little as 4 weeks in male rats without adversely affecting bone~     density. Both bioactive PTH and intact PTH assays have been used and both are reduced by CLA.~     In one rat model, rats had normal PTH and a sub-group had high PTH due to chronic renal~     disease. In the second study, the rats were healthy young males and females. Regardless of~     the model and health state, PTH was reduced 30 to 40% by CLA. Of interest, other isoforms of~     CLA such as trans-10, cis-12 CLA do not alone result in reduced PTH. The selected CLA isomer~     proven to reduce PTH, cis-9, trans 11 CLA, is common to food products such as milk fat and~     beef and is thus more physiologically relevant to the human diet. The global objective of~     this study is to, for the first time; assess the effects of CLA on PTH in humans,~     specifically men.~      Healthy men 19-53 years of age are selected since bone mass will have reached a peak by this~     age. Beginning with healthy relatively young men is important versus aging or ill individuals~     since the effect of CLA on PTH has not been examined and aging and illness might confound the~     results.~      Subjects will be recruited using posters and local newspaper advertisements from the general~     population. Men (n=30/group) with healthy weights will be randomized to receive 0, 1.5 or 3 g~     CLA/d for a period of 4 months. At baseline, body weight will be assessed along with whole~     body bone, lean and fat mass using dual energy x-ray absorptiometry (DXA). Regional bone mass~     (lumbar spine, total hip, femoral neck) will also be examined using DXA. A blood sample will~     be taken in the fasted state between 9:00 and 10:00 to examine PTH, ionized Ca, and~     biomarkers of bone metabolism. After each 1 month on the study, the measurements will be~     repeated until end of study.~      Dietary intake will be monitored along with a survey for possible mild side-effects such as~     gastrointestinal discomfort. Data will be examined using a mixed model for random (age,~     weight, vitamin D status) and fixed effects (diet, time) with post-hoc comparisons using~     Bonferroni correction.~   "
225355|NCT00608387|"~     Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have~     been few behaviorally based programs to lessen CVD risk among this population. The purpose of~     this study is to evaluate whether a Web-based program, in addition to usual medical care, can~     lower CVD risk factors among American Indians who have type 2 diabetes and a high risk of~     developing CVD.~   "
225356|NCT00608374|"~     RATIONALE: Drugs used in chemotherapy, such as chlorambucil and fludarabine, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. It is not yet known whether chlorambucil is more effective than~     fludarabine in treating Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic~     lymphoma.~      PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works~     compared with fludarabine as first-line therapy in treating patients with previously~     untreated Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic lymphoma.~   "
225357|NCT00608361|"~     This phase I trial studies the side effects and best dose of dasatinib in treating patients~     with solid tumors or lymphomas that are metastatic or cannot be removed by surgery. Dasatinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
225358|NCT00608348|"~     The purpose of this study is to determine if either hypoglycemia or exercise cause~     differential responses in muscle and skin sympathetic nerve activity.~   "
225359|NCT00608335|"~     Children with fungal infections will be divided into two groups by weight. Children weighing~     < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days~     than children weighing > 25 kg.~   "
225360|NCT00608322|"~     The purpose of this study is to determine whether inhaled nitric oxide is an effective~     treatment for microcirculatory dysfunction and acute organ system failure in the early stage~     of sepsis therapy.~   "
225361|NCT00608296|"~     The purpose of the research is to study brain structure, function and chemistry of patients~     with bipolar disorder who are receiving quetiapine or lithium, in order to better understand~     who benefits from treatment and why they respond to medications.~   "
225421|NCT00607451|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetic and~     pharmacodynamic effects of single doses of Neu-120 in Parkinson's disease patients with~     levodopa-induced dyskinesia.~   "
225362|NCT00608283|"~     Kidney transplants from living donors now account for 40% of all the kidney transplants done~     in the United States. However, the current information on how donating a kidney can affect~     the donor's long term health needs further investigation. The purpose of this study is to~     collect data on a large number of live kidney donors and create and analyze a comprehensive~     database. Information about the number of living kidney donors, including those who have~     experienced kidney failure, heart problems, and death will be gathered for the database.~     Investigators will then use the database to identify the risks of kidney failure, associated~     conditions, and death after living donation. The database will also be used to identify~     characteristics that put donors at higher risk for health problems after donation.~   "
225363|NCT00608244|"~     A three sequence, open-label, multi-center, prospective, study in stable liver transplant~     patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of~     LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.~   "
225364|NCT00608231|"~     To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for~     awake, DBS surgery has no significant effect on electrophysiological parameters of DBS~     micro-electrode recordings~   "
225365|NCT00608218|"~     The aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent~     asthma over 3 months, especially in the cold season. Ciclesonide will be inhaled by a~     metered-dose inhaler. The study will provide further data on safety and tolerability of~     ciclesonide.~   "
225366|NCT00608205|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is~     not yet known whether radiation therapy and cisplatin are more effective with or without~     fluorouracil in treating patients with head and neck cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to~     compare how well they work with or without fluorouracil in treating patients with stage III~     or stage IV head and neck cancer.~   "
225367|NCT00608192|"~     This randomized clinical trial will examine the effectiveness of a strategy of HIV and~     Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and~     vaccination for methadone maintenance patients compared with standard Testing, Education, and~     Counseling (TEC).~   "
225368|NCT00608179|"~     This study will look at two FDA approved medications that improve how the pancreas works in~     patients with Type 2 Diabetes. In order to understand how these medications work in patients~     with diabetes we must first measure the normal response in healthy volunteers without~     diabetes. We will be looking at the body's normal physiological response to low blood sugar~     and whether this will be modified by these medicationsThe hypothesis would be that~     glimepiride induced insulin secretion will be inhibited by hypoglycemia.~   "
225369|NCT00608153|"~     The CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg~     candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions,~     i.e. under routine medical care conditions, the subject compliance as well as the efficacy~     and tolerability of candesartan or candesartan/HCT in subjects suffering from essential~     hypertension.~   "
225370|NCT00608140|"~     Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the~     heart's mitral valve, located between two of the heart's main chambers, does not firmly shut,~     allowing blood to leak backwards within the heart. Improper functioning of the mitral valve~     disrupts the proper flow of blood through the body, resulting in shortness of breath and~     fatigue. When mild, MR may not pose a significant danger to a person's health, but severe MR~     may be associated with serious complications, such as heart failure, irregular heart rhythm,~     and high blood pressure. Although there are treatments for MR, including medication and~     surgery, more information is needed on the effectiveness of these treatments in people with~     significant MR. This study will compare the safety and effectiveness of corrective surgery~     added to optimal medical treatment (OMT) versus OMT alone in treating people with significant~     MR caused by an enlarged heart.~   "
225371|NCT00608127|"~     Systemic Lupus Erythematosus (SLE) is a chronic, autoimmune, inflammatory disease primarily~     affecting women of childbearing age, and associated with severe morbidity and mortality of~     its victims. The existing therapy, however, is not specific and its inevitable side effects~     may themselves be fatal. Therefore, it is a widely recognized need for, and it would be~     highly advantageous to have a safe, specific rapidly effective and well-defined treatment of~     SLE, devoid of the disadvantages.~      We have shown that VRT101 a peptide present in the extracellular laminin is a target for~     pathogenic lupus autoantibodies. Using this peptide we have developed the LupusorbTM - an~     immune-adsorption column which specifically binds pathogenic antibodies from monoclonal~     cultures as well as from patients` plasma. The investigational product named LupusorbTM~     Column is a sterile medical device for single use and can be classified into category IIb~     (synthetic ligands, peptides) according to Annex IX of the European Medical Device Directive~     42/93/EEC.~      The proposed study, a pilot non-randomized open label study, will test the safety,~     Tolerability and short term efficacy of a single immunoadsorption procedure in SLE patients.~   "
225372|NCT00608101|"~     The purpose of this study is to determine what corticosteroid receptor (and the dose of) is~     responsible for cortisol inducing hypoglycemia associated autonomic dysfunction in Type 1 DM.~     Specifically, we aim to determine whether stimulating the type 1 corticosteroid receptor (via~     fludrocortisone), the type 2 corticosteroid receptor (via dexamethasone), or both causes~     hypoglycemia associated autonomic dysfunction in Type 1 DM.~   "
225373|NCT00608088|"~     This research was done to better understand how new mothers who are breastfeeding feel and~     the questions they have. We wanted to use ways to help new mothers to breastfeed~     successfully. We compared a new approach (home visits and telephone calls) to the usual care~     given at Johns Hopkins Hospital with strong support to new mothers from nurses, and a peer~     counselor (another mother with breastfeeding experience).~   "
225374|NCT00608075|"~     The purpose of the research is to study brain structure, function and chemistry of patients~     with bipolar disorder who are receiving lithium, an FDA-approved treatment for bipolar mania,~     in order to better understand who benefits from treatment and why they respond to~     medications. Studying this may help improve treatment and outcome in patients with bipolar~     disorder.~   "
225451|NCT00607048|"~     This is a dose-finding study; therefore, there is no hypothesis testing~   "
225376|NCT00608049|"~     Cardiovascular disease (CVD) and diabetes are health conditions that are strongly influenced~     by a person's diet. Although the best diet to prevent CVD and diabetes is uncertain, reducing~     intake of saturated and transunsaturated fats is known to help lower cardiovascular risk.~     However, even diets low in these fats can vary widely in other energy providing nutrients,~     particularly carbohydrates. This study will determine the effects of a higher versus lower~     carbohydrate diet, each with a high or low glycemic index (GI) composition, on risk factors~     for CVD and diabetes.~   "
225377|NCT00608036|"~     Many teenagers have unhealthy eating habits and do not get enough physical activity. This~     study will examine whether the neighborhood in which a teenager lives affects his/her quality~     of life, physical activity levels, and eating habits.~   "
225378|NCT00608023|"~     HIV lipodystrophy affects a significant proportion of patients treated with combination~     antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss~     of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance.~     Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated~     that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV-~     infected patients with excess of abdominal fat accumulation for 26 weeks resulted in~     decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and~     subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations~     made during the first Phase 3 study.~   "
225379|NCT00608010|"~     Embryo preservation through freezing plays a significant role in human assisted reproduction.~     It provides an opportunity for patients to have more than one attempt following an ovarian~     stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins~     and improving cumulative pregnancy rates. The purpose of this study is to compare~     effectiveness of two different freezing methods.~   "
225380|NCT00607997|"~     This study will evaluate the overall remission rate of treatment with vosaroxin (formerly~     voreloxin) Injection in patients at least 60 years of age with previously untreated AML~   "
225381|NCT00607984|"~     The prognosis of children and adolescents with high risk tumors of the central nervous system~     and other miscellaneous solid tumors is poor despite modern treatment protocols. Frequently,~     physicians suggest additional therapy with high dose chemotherapy after a good initial~     response to standard doses of treatment has been obtained, so as to reduce the chance that~     the tumor will recur. We propose a regimen of high dose thiotepa and melphalan followed by~     rescue of the patient's previously stored hematopoietic (blood manufacturing) system with~     blood stem cells. The aim of this study is to prove that this therapy is tolerable in~     children and adolescents, that it results in tolerable levels of toxicity, and that it~     improves the survival of this group of children as compared to standard therapy given in the~     past~   "
225382|NCT00607971|"~     The main purpose of this study is to evaluate the long-term safety and tolerability of~     renzapride at a dose of 4 mg taken once daily for 12 months in women with~     constipation-predominant irritable bowel syndrome (IBS-C).~   "
225383|NCT00607958|"~     Tipranavir is a drug with a high antiretroviral activity, also in presence of major mutations~     in the protease gene. However, its necessity of being co-administered with 400 mg of~     ritonavir daily, limits its efficacy for the treatment of HIV-infected patients, due to the~     high incidence of gastrointestinal adverse events. Nevertheless, tipranavir plasma though~     concentrations were higher than the proposed minimum effective concentration for patients~     with previous experience with protease inhibitors (PI) in half of patients treated with~     tipranavir/ritonavir at 500/100 mg dose every 12 hours. Furthermore, when the number of~     mutations in the protease gene is limited, there are no differences in the reduction of the~     viral load between patients treated with tipranavir/ritonavir at 500/200 mg and 500/100 mg~     every 12 hours. At last, the efficacy of tipranavir treatment has been more closely related~     with the inhibition quotient (IQ) than with concentrations considered isolated.~      Considering the previous arguments, it can be hypothesized that, basing in every subject IQ,~     it could be possible to identify those patients HIV-infected in treatment with~     tipranavir/ritonavir at 500/200 mg every 12 hours that could take advance of the reduction of~     ritonavir to 100 mg every 12 hours, without compromising the viral replication control. This~     strategy could improve the tolerability to the treatment, what could result in a better~     adherence and less proportion of treatment abandon due to this reason~   "
225384|NCT00607945|"~     The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA,~     might be useful in combination with diabetes medication. Some studies show that CLA can~     modestly reduce body weight and body fat. Our research idea is that taking CLA will reduce~     body weight and body fat without interfering with the diabetes medications' effects on blood~     sugar.~   "
225385|NCT00607932|"~     RATIONALE: Eating a diet high in vegetables may lower the risk of some types of cancer.~     Brassica vegetables (such as cabbages, kale, broccoli, Brussels sprouts, and cauliflower) and~     indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of~     prostate cancer recurrence.~      PURPOSE: This randomized clinical trial is studying the side effects and how well Brassica~     vegetables work compared with indole-3-carbinol in treating patients with PSA recurrence~     after surgery for prostate cancer.~   "
225386|NCT00607919|"~     This study will evaluate the effect of atomoxetine in treating~     Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with~     ADHD and comorbid reading disability (dyslexia)~   "
225387|NCT00607906|"~     This study will use single escalating doses of SB756050 to assess safety, pharmacokinetics,~     and pharmacodynamics in healthy volunteers and in subjects with Type 2 Diabetes Mellitus.~   "
225388|NCT00607893|"~     Sleep-disordered breathing (SDB) is a condition in which a person experiences frequent~     breathing pauses during sleep, also known as sleep apnea. There is evidence that the~     recurrent sleep arousal and associated shortage of oxygen in the body may increase risk for~     cardiovascular disease (CVD). It is believed that treatment with continuous positive airway~     pressure (CPAP) may reduce certain risk factors for heart disease, including markers of~     inflammation and oxidative stress. This study will evaluate the effectiveness of CPAP in~     reducing CVD risk factors in people with SDB.~   "
225452|NCT00607035|"~     The purpose of this study is to investigate which combination therapy is more effective for~     improving the blood pressure (BP) and reducing target organ damage in Japanese hypertensive~     patients: Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB~     plus diuretics.~   "
225389|NCT00607880|"~     RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple~     needle sticks. It is not yet known whether one type of port is more effective than another in~     reducing infections and other side effects associated with long-term port use.~      PURPOSE: This randomized clinical trial is comparing two types of ports in patients with~     cancer receiving intravenous chemotherapy.~   "
225390|NCT00607867|"~     We will determine the metabolic response to a Low Biologically Available Glucose Diet~     (LoBAG30) in subjects currently receiving the maximum dose of metformin as monotherapy in~     whom the glycohemoglobin is not at an acceptable level (>8.0%). Our hypothesis is that~     introduction of a LoBAG30 diet to subjects currently treated with a full therapeutic dose of~     metformin will improve blood glucose control in people who have not achieved an acceptable~     total glycohemoglobin on metformin alone.~   "
225391|NCT00607854|"~     The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced~     Intensity Conditioning regimen followed by allogenic stem cell support in patients with~     aggressive lymphomas who are responsive to a salvage chemotherapy regimen.~   "
225392|NCT00607841|"~     Phase I is a dose-escalation study designed to assess safety and tolerability in patients~     with metastatic breast cancer. Phase II will measure response rate in patients with~     metastatic breast cancer.~   "
225393|NCT00607828|"~     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor~     and cause less damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic~     radiation therapy in treating patients with advanced liver cancer.~   "
225394|NCT00607815|"~     The purpose of this study is to compare the effectiveness of Cognitive Processing Therapy~     (CPT) versus Present Centered Therapy (PCT) for male OEF/OIF Veterans with combat related~     PTSD.~   "
225395|NCT00607802|"~     RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with~     cancer.~      PURPOSE: This clinical trial is studying the side effects of donor white blood cell infusion~     in treating patients with metastatic or unresectable cancer.~   "
225396|NCT00607789|"~     The purpose of this research study is to test the safety of duloxetine and see what effects~     (good and bad) it has on the subject's binge eating disorder and comorbid depressive disorder~     (depression occurring with binge eating disorder) compared to placebo (inactive pill).~   "
225397|NCT00607776|"~     The mean change in the subjective comfort score from baseline of the test group is at least~     2.0 units less than that of the control group.~   "
225398|NCT00607763|"~     Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an~     antifungal drug. Safety and drug blood levels will be assessed~   "
225399|NCT00607750|"~     This study is a double-masked, randomized, placebo-controlled study of the safety and~     preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance~     injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be~     effective in the treatment of neovascular AMD.~   "
225400|NCT00607737|"~     To compare application site reactions after superficial and deep subcutaneous and intradermal~     injections of insulin detemir and saline in patients with diabetes~      - The patient serves as his own control, n=100 patients with diabetes~   "
225401|NCT00607724|"~     RATIONALE: Drugs used in chemotherapy, such as GDC-0449, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of GDC-0449 in~     treating patients with locally advanced or metastatic solid tumors.~   "
225402|NCT00607711|"~     The study of maximum tolerated dose and safety of oral palifosfamide tris capsules in~     advanced, refractory, solid tumors~   "
225403|NCT00607685|"~     Trabeculectomy is the most effective method of lowering intraocular pressure in glaucoma that~     is not well controlled with drop medication. The post-operative wound healing response~     remains the major barrier in surgical success. Scar tissue formation results in occlusion of~     the surgical drainage site created. As a consequence, the intraocular pressure rises once~     again. The current use of anti-scarring agents such as 5 Fluorouracil (5FU), is a well~     established method employed by ophthalmologists to clinically reduce the postoperative~     scarring response. However, in patients with a high risk of bleb failure, repeated~     subconjunctival injections of 5FU following bleb needling is often required resulting in~     increased clinical load and patient inconvenience. A slow release formulation of 5FU would be~     of benefit by releasing the 5FU into the subconjunctival space over an extended period~     thereby providing a prolonged therapeutic effect. In addition, hyaluronic acid is known to~     possess antifibrotic properties and from its gel-like physical state, would potentially act~     as a physical tissue spacer that may further limit active subconjunctival scarring at the~     site where it is injected. We hypothesise that injecting a mixture of 5FU with hyaluronic~     acid would give better outcomes than injecting 5FU alone.~      The aim of this study is to determine whether bleb needling with subconjunctival injection of~     Viscoelastic/5FU formulation is an effective method for prolonged drug delivery in preventing~     the post-operative scarring response. This will be a prospective case-controlled study~     involving patients who have already undergone trabeculectomy and who require bleb needling~     and subconjunctival 5FU injections.~   "
225416|NCT00607516|"~     Substudy and continuation of HEMI-SAB-UUS (NCT00491673)~      Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and~     measurements of periprosthetic bone mineral density in cemented and uncemented~     hemiarthroplasties in patients with femoral neck fractures.~      Null hypothesis: No difference in acetabular wear or in bone mineral density changes between~     cemented and uncemented hemiarthroplasties~   "
225417|NCT00607503|"~     The purpose of the study is to gain experience with the use of terbutaline in children with~     T1D and to determine that there is not a frequent serious, unexpected, uncontrollable effect~     on short-term glycemic control. Some information also will be obtained with regard to whether~     terbutaline, in the dosing being used in the study, is sufficiently well tolerated to expect~     that adherence will be satisfactory in a large randomized trial. In addition, this pilot~     study will provide data on the accuracy of a continuous glucose monitor during terbutaline~     use to verify that the drug does not impact on sensor function.~   "
225418|NCT00607490|"~     This study will evaluate the relative effectiveness of cognitive-behavioral therapy and~     supportive psychotherapy for the treatment of women with vulvodynia.~   "
225404|NCT00607672|"~     Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary~     bypass (CPB).1 CPB is associated with significant morbidity including hemodynamic~     instability, the transfusion of allogenic blood products, and inflammation. Blood product~     transfusion increases mortality after cardiac surgery. Enhanced fibrinolysis contributes to~     increased blood product transfusion requirements in the perioperative period. CPB activates~     the kallikrein-kinin system (KKS), leading to increased bradykinin concentrations.~     Bradykinin, acting through its B2 receptor, stimulates the release of nitric oxide,~     inflammatory cytokines and tissue-type plasminogen activator (t-PA). Based on data indicating~     that angiotensin-converting enzyme (ACE) inhibitors reduce mortality in patients with~     coronary artery disease, many patients undergoing CPB are taking ACE inhibitors. While~     interruption of the renin-angiotensin system (RAS) reduces inflammation in response to CPB,~     ACE inhibitors also potentiate the effects of bradykinin and may augment B2-mediated change~     in fibrinolytic balance and inflammation. In contrast, angiotensin II type 1 receptor~     antagonism does not potentiate bradykinin and does not inhibit bradykinin metabolism.~      Studies in animals suggest that bradykinin receptor antagonism inhibits reperfusion-induced~     increases in vascular permeability and neutrophil recruitment.A randomized, placebo~     controlled clinical trial of a bradykinin B2 receptor antagonist demonstrated some effect on~     survival in patients with systemic inflammatory response syndrome and gram-negative sepsis.~     In addition, we and others have shown bradykinin B2 receptor antagonism reduces vascular t-PA~     release during ACE inhibition. The current proposal derives from data from our laboratory and~     others elucidating the role of the KKS in the inflammatory, hypotensive and fibrinolytic~     response to CPB. Specifically, we have found that CPB activates the KKS and that ACE~     inhibition and smoking further increases bradykinin concentrations. During CPB, bradykinin~     concentrations correlate inversely with mean arterial pressure and directly with t-PA.~     Moreover, we have found that bradykinin receptor antagonism attenuates protamine-related~     hypotension following CPB. The current proposal tests the central hypothesis that the~     fibrinolytic and inflammatory response to cardiopulmonary bypass differ during~     angiotensin-converting enzyme inhibition and angiotensin II type 1 receptor antagonism.~   "
225405|NCT00607659|"~     Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern~     due to their prevalence and potentially devastating reproductive consequences, including~     pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to~     evaluate the risk factors for adverse outcomes following genital tract infection with~     Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the~     rectum act as a reservoir for infection.~   "
225406|NCT00607646|"~     Elevations of plasma cortisol, a stress hormone, during prior episodes of low blood sugar~     (hypoglycemia) appear to be responsible for the deficient responses during subsequent~     hypoglycemia. Our specific aim is to determine if dehydroepiandrosterone (DHEA), a hormone~     with anti-corticosteroid actions, can prevent hypoglycemia associated autonomic failure in~     type 1 diabetic volunteers.~   "
225407|NCT00607633|"~     The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg~     candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions,~     i.e. under routine medical care conditions, the impact of the antihypertensive therapy with~     candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular~     hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT~     in subjects suffering from essential hypertension..~   "
225408|NCT00607620|"~     The goal of the Disseminating Organizational Screening and Brief Interventions Services~     (DO-SBIS) investigation is to capitalize on the unique opportunity afforded by the American~     College of Surgeons' mandate by taking early steps to insure high quality, evidence-based SBI~     services are implemented and outcomes are assessed. In the first phase of the investigation,~     SBI services will be assessed for all 190 level I trauma centers in the United States. In the~     second phase of the investigation, 20 level I trauma centers will be selected for~     randomization to intervention or control conditions.~   "
225409|NCT00607607|"~     Patients will be treated with MKC-1, twice daily for 14 consecutive days every four weeks (a~     cycle of MKC-1 chemotherapy), until disease progression or unacceptable toxicities. Patients~     will be stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive~     identical treatment regimens.~   "
225410|NCT00607594|"~     This phase II trial is studying how well saracatinib works in treating patients with locally~     advanced or metastatic stomach or gastroesophageal junction cancer. Saracatinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
225411|NCT00607581|"~     The treatment of light-chain (AL) amyloidosis is directed against the plasma cells that~     produce the light-chain forming the amyloid deposits. The plasma cells can be killed and~     their growth can be stopped by drugs used in chemotherapy, such as cyclophosphamide,~     steroids, such as dexamethasone, and drugs that stimulate the immune system, such as~     lenalidomide.~      The present trial studies the efficacy and safety of the combination of cyclophosphamide,~     lenalidomide and dexamethasone in patients with AL amyloidosis who were previously treated~     and need further therapy.~   "
225412|NCT00607568|"~     A total of 18 healthy volunteers will participate in this four-week, within-groups,~     double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day~     washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or~     placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After~     receiving medication or placebo for three days, subjects will have a 6-hour laboratory~     session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg~     maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and~     subjective outcome measures will be obtained during the experimental sessions. Subjects will~     then have a 4-15 day washout period and will be crossed over to the alternative treatment for~     Phase II.~   "
225413|NCT00607555|"~     In this study, we want to see how feeding affects breathing in small premature babies. Using~     a special feeding tube in the stomach, we can measure how the diaphragm (a large breathing~     muscle) might be affected by feeding. We also want to see if slowing down the feeding may~     lessen this effect.~   "
225414|NCT00607542|"~     Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although~     for adults there is dosing,safety and efficacy information in the package insert, this is not~     the case for children. The purpose of this study is to determine how fast the drug is cleared~     from the body, the correct dose, and long-term safety and efficacy for children with~     spasticity.~   "
225415|NCT00607529|"~     This study is being done to see if the Nova Creatinine Meter can give a correct measure of~     creatinine (a blood test used to measure kidney function) when the blood is taken from a~     capillary (smallest type of blood vessels). The Nova Creatinine Meter is a hand held device~     that can be used in a clinic to measure creatinine in about 50 seconds. Current laboratory~     creatinine testing can take up to an hour. Since chemotherapy patients need to have their~     creatinine measured prior to treatment, this meter could make testing easier and faster.~   "
225419|NCT00607477|"~     The purpose of this study is to describe the length of time and extent of blood pressure~     response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular~     endothelial growth factor (VEGF) inhibitor treatment induced hypertension.~   "
225422|NCT00607438|"~     This is a Phase II, open-label, non-randomized study in patients with locally advanced or~     metastatic breast cancer.~      Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 weeks.~     Patients will not receive Abraxane during week 4 (rest week). Nexavar will be given~     continuously.~      Patients will be radiologically evaluated every 8 weeks for response. Patients will continue~     to receive study treatment until disease progression or unacceptable toxicity.~   "
225423|NCT00607425|"~     This is a pilot study to test the feasibility of using gene expression from saliva to~     identify patients with early-stage non-small cell lung cancer (NSCLC).~      The primary objective of this study is to compare gene expression profiles from saliva from~     healthy controls and patients with early-stage non-small cell lung cancer.~      To be eligible, patients with non-small cell lung cancer, must not yet have received~     treatment for their cancer (surgical removal, chemotherapy, or radiation therapy). Health~     control participants may participate if they meet eligibility criteria listed below.~      Eligible enrollees will be asked to submit a one time saliva sample and complete a study~     questionaire.~   "
225424|NCT00607412|"~     The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders~     among women who have experienced domestic violence. The hypothesis is that women who receive~     present-focused, integrated treatment will have greater PTSD symptom reduction and have less~     substance use after treatment than women in the control condition who will receive supportive~     therapy based on a 12-step approach.~   "
225425|NCT00607399|"~     SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity~     may be important in growth and survival of some types of cancer. This Phase I trial is~     studying the safety, side effects, and best dose of SGX523 when given to patients with~     advanced cancer, and how well it inhibits MET activity in tumors.~   "
225426|NCT00607386|"~     The objective of this study is to determine the safety of once weekly dosing of idursulfase~     0.5 mg/kg administered by intravenous (IV) infusion for male Hunter syndrome patients ≤ 5~     years old.~   "
225427|NCT00607373|"~     The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012)~     in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy.~      This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up~     period. Following treatment and Week 28 evaluations, participants could elect to enroll in an~     open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or~     elected not to enroll in the open-label extension study or who discontinued during the~     28-week treatment period were followed in this study for 24 weeks from administration of the~     last dose of study drug.~   "
225428|NCT00607360|"~     Drug Courts were developed as a therapeutic alternative to incarceration of drug-involved~     offenders by providing 'judicially supervised' drug abuse treatment and probation for~     nonviolent offenders in lieu of criminal prosecution and incarceration. Outcome studies have~     shown that drug courts have modest effects on participation in drug abuse treatment, drug~     use, and employment. The Therapeutic Workplace intervention is an effective employment-based~     treatment that integrates abstinence reinforcement contingencies in a work setting, intended~     to treat individuals with histories of drug addiction and chronic unemployment. Under this~     intervention, drug abuse patients are hired and paid to work. To promote abstinence, patients~     are required to provide drug-free urine samples to gain and maintain daily access in the~     workplace. In this way, patients can work and earn salary, but only as long as they remain~     drug abstinent. Patients using drugs and lacking job skills participate in an initial~     training phase to initiate abstinence and establish computer data entry skills. Once~     abstinent and skilled, patients are hired into an income-producing Therapeutic Workplace data~     entry business. Given that many drug court participants suffer from long histories of drug~     addiction and unemployment, the Therapeutic Workplace could be ideal for this population.~     This proposes of this clinical trial is to evaluate the Therapeutic Workplace intervention in~     a Drug Court.~   "
225429|NCT00607347|"~     The researchers hypothesize that the impact of increasing systemic exposure to atenolol leads~     to increased risk for adverse metabolic effects from atenolol therapy in hypertension. This~     will be accomplished through a 24-hour pharmacokinetic (PK) study and oral glucose tolerance~     test in hypertensive patients taking chronic atenolol 100 mg daily.~   "
225430|NCT00607334|"~     The purpose of this study is to compare the performances of normally developing children and~     children with Language Impairment (LI) in three different experimental settings designed to~     promote vocabulary acquisition. This comparison will also provide evidence to support~     different intervention approaches designed to increase vocabulary abilities, which has been~     proved to be one of the major deficits of young children with LI.~   "
225431|NCT00607321|"~     To assess the feasibility and safety of the Medtronic Bifurcation Stent System for the~     treatment of single de novo bifurcation lesions in native coronary arteries with reference~     vessel diameters (RVD) for the proximal main vessel of 3.8 - 4.3 mm, distal main branch of~     3.0 - 3.5 mm, and side branch RVD up to 2.5 mm.~   "
225432|NCT00607308|"~     The purpose of this study is to examine the safety, tolerability, pharmacokinetics,~     pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects~     with mild to moderate Alzheimer's Disease.~   "
225433|NCT00607295|"~     1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy,~          urogenital atrophy is common, the patients are seldomly treated for several reasons.~          Management of this problem is important for improving quality of life.~        2. Clino-san is a kind of vaginal lubricant with pH 5 which is similar pH of~          premenopausal vaginal discharge. After randomization of patients, they are treated with~          Clino-san or placebo 3 times/week for 12 weeks.~        3. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at~          baseline, 4, 8, and 12 weeks of treatment.~   "
225434|NCT00607282|"~     The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A~     Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical~     resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will~     be evaluated in treatment for patient with chronic erectile dysfunction, which developed~     after radical resection for sigmoid and rectal cancer and continues 12 months after the~     surgery.~   "
225921|NCT00600769|"~     Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium~     avium-intracellulare and other non-tuberculous Mycobacteria~   "
225435|NCT00607269|"~     This study evaluates a contingency management program that rewards homeless,~     non-treatment-seeking substance abusing men who have sex with men (MSM) for abstaining from~     drugs and for performing prosocial behaviors. If this program motivates these individuals to~     increase prosocial and healthy behaviors and decrease drug/alcohol use, established~     prevention programs may modify their approaches to include contingency management, and use it~     to address the staggering public health problems homeless substance-abusing MSMs face on a~     daily basis.~   "
225436|NCT00607256|"~     To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with~     fibromyalgia~   "
225437|NCT00607243|"~     The currently available stock of smallpox vaccine would be insufficient in the face of an~     incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are~     urgently needed because previous manufacturing methods using calf lymph are no longer~     acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea~     has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by~     infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,~     and immunogenicity of CJ-50300.~   "
225438|NCT00607230|"~     Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the~     pancreas. The investigators have discovered the specific autoimmune cells responsible for~     destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means~     of destroying those cells.~   "
225439|NCT00607217|"~     This study wishes to understand:~        1. whether vaccination against influenza in coronary artery disease (myocardial infarction~          and stable angina) patients is as effective as it is in healthy subjects;~        2. whether vaccination really decreases the episodes of influenza infection in those~          coronary artery disease patients who receive the vaccine than those who do not.~   "
225440|NCT00607204|"~     Sleep is necessary for healthy functioning, and people who sleep too little or too much may~     have an increased risk of developing health problems. This study will examine people who~     regularly sleep for short or long amounts of time to understand the biological factors that~     determine how much sleep a person needs.~   "
225441|NCT00607191|"~     To build a DNA repository to enable participation in ongoing and future Clubfoot genetic~     linkage studies.~   "
225442|NCT00607178|"~     Influenza vaccine reduces the cardiovascular events in post-myocardial infarction (MI)~     patients and in those with stable angina (SA).~   "
225443|NCT00607152|"~     Primary:~      To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related~     hyperuricemia in Chinese patients with leukemia or lymphoma.~      Secondary:~      To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients~     stratified according to disease (leukemia or lymphoma ).~   "
225444|NCT00607139|"~     The primary objective of this study will be to compare the glucose level at which~     counter-regulatory hormone responses occur during hypoglycemia in young children with~     diabetes, with the glucose level counter regulatory hormone responses that occur in older~     children with diabetes.~   "
225445|NCT00607126|"~     Locomotor training is a new exercise modality that emphasizes task specificity to promote~     learning and neural plasticity. It has been reported to improve walking in patients with~     stroke, spinal cord injury and cerebral palsy. In this study, 40 patients with impaired~     ambulation due to Multiple Sclerosis will be randomized to receive 36 sessions of either~     locomotor training or an standard resistive exercise intervention.The locomotor training will~     be accomplished via a robotic device, the Lokomat, which will move the patient's legs on a~     treadmill while they are suspended in a harness.~   "
225446|NCT00607113|"~     Primary Objectives:~        -  To determine the effect of Avastin on tumor blood flow as determined by functional~          computed tomography (CT) in patients with low or intermediate grade neuroendocrine~          carcinoma.~        -  To determine the effect of RAD001 on tumor blood flow as determined by functional CT in~          patients with low or intermediate grade neuroendocrine carcinoma.~        -  To determine the effect of adding the second agent (Avastin or RAD001) to the first~          agent (RAD001 or Avastin) on tumor blood flow as determined by functional CT~      Secondary Objectives:~        -  To determine the clinical activity (objective response rate and progression free~          survival duration) of Avastin and RAD001 in patients with low or intermediate grade~          neuroendocrine carcinoma.~        -  To determine the biochemical response rate of Avastin and RAD001 in patients with low or~          intermediate grade neuroendocrine carcinoma.~        -  To determine the safety and tolerability of Avastin and RAD001 in patients with low or~          intermediate grade neuroendocrine carcinoma.~   "
225447|NCT00607100|"~     The purpose of this study is to compare the abilities of high-speed,high-resolution (HR)~     optical coherence tomography (OCT) and Stratus OCT for detection of retinal nerve fiber layer~     (RNFL) loss in eyes with band atrophy (BA) of the optic nerve.~   "
225448|NCT00607087|"~     Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart~     and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or~     infusion set occlusion.~      Main Secondary objectives:~      To compare insulin glulisine, insulin aspart and insulin lispro on:~        -  Unexplained hyperglycemia~        -  Infusion set occlusion~        -  Hypoglycemic episodes,7-point blood glucose profiles~        -  Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis~        -  Time to change the infusion set~        -  HbA1c (Glycosylated hemoglobin)~        -  Overall safety: incidence of adverse events~   "
225449|NCT00607074|"~     This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic~     treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.~   "
225450|NCT00607061|"~     The aim of the study is to determine mechanisms leading to glutathione deficiency in low~     birth weight newborn babies. Compared to full term neonates, depletion in this population may~     be due to a decreased synthesis rate or to an enhanced utilization or a combination of both~     mechanisms.The protocol is constituted of two steps. The objective of the first step is to~     quantify the blood concentration of glutathione in the artery and the vein of umbilical cord~     in full term newborn babies. Objectives of the second step are to determine if the~     glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from~     umbilical cord blood of low weight newborn babies compared to full term newborn babies. In~     this case, the next objective will be to determine if the adjunction of an excess of cysteine~     in vitro can restore the glutathione synthesis rate in these cells.~   "
225453|NCT00607022|"~     This is a research study to test the clinical procedure and not the FDA approved medical~     device. This project will screen up to 80 volunteers to enroll 40 active subjects to receive~     a single tooth implant on an anterior (incisor/canine) or pre-molar tooth in the mandible or~     maxilla (no implants will be placed in molar sites). This 3 year research study will examine~     the clinical effects of loading regimens on roughened surfaced implants. The proposed~     research project will measure the changes in mucosal healing and maturation over a three year~     period following implant placement. The proposed research lays the foundation for improved~     health care by providing surgeons and restorative dentists with data for determining the~     relationship between implant healing, loading pattern and bone type. The rationale that~     underlies the investigation is that identification of the influences of timing of load on~     implant stability in varying bone types will allow routine, predictable use of early loading,~     which, in turn, will translate into more rapid health care, and improved psychosocial~     well-being of the patient. If these hypotheses are correct, these results are expected to~     provide evidence based research data to support early loading and immediate loading of single~     implants in sites of adequate bone volume, and density. In addition, it is expected that~     these results will fundamentally advance the field of implant dentistry and bioengineering by~     providing information on the principles of the bone density-mechanical environment-implant~     stability interaction.~   "
225454|NCT00607009|"~     The objective of this study is to test the effectiveness of an email-based diet and physical~     activity intervention on increasing physical activity and fruit and vegetable consumption and~     decreasing intake of saturated and trans fats and added sugars.~   "
225455|NCT00606996|"~     The purpose of the study is to determine whether interpersonal psychotherapy is effective for~     treating co-occurring depression and substance use among women prisoners.~   "
225456|NCT00606983|"~     Various adrenergic blockers are used for acute voiding difficulty after proctectomy.~     Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit~     in reducing urinary symptom score and in reducing the rate of intermittent~     self-catheterization for patients with rectal cancer after radical proctectomy.~      This study is to evaluate the efficacy of pharmacologic prevention to ameliorate the~     incidence of postoperative urinary dysfunction.~   "
225457|NCT00606970|"~     Project: Assessment of the safety of dietary supplement lactobacillus fermented extract in~     cancer patients undergoing chemotherapy~      Nausea and vomiting are significant causes of nutritional depletion and result in further~     deterioration of the physical and mental status. Support of gastrointestinal function may~     alleviate nausea and vomiting from chemotherapy and will not only reduce the discomfort~     experienced by the patient but will allow better tolerance of the treatment. This study will~     assess orally administered Seigen alpha EV during chemotherapy for its safety and effects on~     the nutritional depletion deriving from the chemotherapy. It will also look at its effect on~     the immune system in patients undergoing chemotherapy.~   "
225458|NCT00606957|"~     The reason for doing this study is to learn whether raising a person's vitamin D level from~     below normal to normal levels will improve his or her body's ability to use sugar. Vitamin D~     is well known to be an important vitamin for the development and maintenance of bones.~     Recently, scientists have learned that vitamin D may have a role in the prevention of cancer,~     diabetes, and autoimmune diseases. The investigators are specifically interested in studying~     this question in the overweight/obese population as they are at greater risk for both vitamin~     D deficiency and impaired ability to metabolize sugar (glucose intolerance).~      Primary Hypotheses:~      Vitamin D repletion (increasing the serum 25(OH)D level from ≤ 20 ng/ml to ≥ 30 ng/ml) will~     improve insulin sensitivity in individuals who are overweight/obese and insulin resistant.~      Secondary Hypotheses:~      1.Vitamin D repletion will improve biomarkers of cardiovascular risk and inflammation~     (directly altering macrophage cytokine production and/or indirectly as a result of~     improvement in insulin sensitivity.) 2.30,000 IU (0.25 mg) weekly of cholecalciferol (vitamin~     D3) will raise serum 25(OH)D levels from ≤ 20 ng/ml to ≥ 30 ng/ml overweight/obese~     population.~   "
225459|NCT00606944|"~     The purpose of this study is to address the question of whether or not oral alimentation and~     ambulation exercise should be begun early in patients following laparoscopic colorectal~     surgery compared to the classical diet and ambulation which depends on reappearance of~     functional intestinal transit. Early oral alimentation following laparoscopic colorectal~     surgery may decrease hospital stay and facilitate earlier discharge with comparable~     postoperative morbidity.~   "
225460|NCT00606931|"~     The purpose of this pilot clinical study is to test a methodology for using high-resolution~     Positron Emission Tomography (PET) imaging to guide vacuum-assisted core biopsy of breast~     abnormalities identified on PET. In order to implement the PET guidance, the study uses the~     Stereo Navigator accessory to the high-resolution organ-specific PET scanner (PEM Flex™ PET~     Scanner, Naviscan PET Systems, Inc., San Diego, CA). The Stereo Navigator is an~     investigational device intended for guiding biopsy needles toward lesions in breasts~     identified by a physician on a high resolution PET image. The study will evaluate the~     clinical utility of the Stereo Navigator in guiding the vacuum-assisted core biopsy of breast~     abnormalities, following the example of prior studies of breast biopsy guided by magnetic~     resonance imaging (MRI)~   "
225461|NCT00606918|"~     There is a great need for the development of sensitive outcomes that allow experimental drugs~     to be tested in human subjects more efficiently. If we could more precisely measure whether~     an experimental drug slows the progression of ALS or other neuromuscular diseases, this would~     allow more drugs to be tested quicker and at less expense. We have developed a new device~     that accurately measures isometric strength called: Accurate Test of Limb Isometric Strength~     (ATLIS). This device was designed to be portable, quick, and easy to use, while generating~     accurate and reliable, interval level data. This study will enable us to test the reliability~     and validity of ATLIS.~   "
225462|NCT00606905|"~     Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are~     trying to establish a family. This clinical study will evaluate the effectiveness of~     intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from~     secondary recurrent miscarriage. This study will help in providing an answer to the question~     of whether IVIG is helpful in secondary recurrent miscarriage.~   "
228945|NCT00560300|"~     To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and~     two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests~     of children with kidney failure~   "
225463|NCT00606892|"~     To examine the effects of varenicline on the subjective, physiological and cognitive~     responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is~     approved as a treatment for smoking cessation. We predict that varenicline treatment will~     modify subjective, physiological and cognitive responses to IV nicotine.~   "
225464|NCT00606879|"~     SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity~     may be important in growth and survival of some types of cancer. This Phase I trial is~     studying the safety, side effects, and best dose of SGX523 when given to patients with~     advanced cancer, and how well it inhibits MET activity in tumors.~   "
225465|NCT00606866|"~     The purpose of this study is to determine maximum tumor shrinkage, time to progression,~     survival, drug concentration, and degree of skin toxicity.~   "
225466|NCT00606853|"~     The purpose of this study is to address the conditions under which prize contingency~     management (CM) for abstinence and attendance may improve outcomes of cocaine-dependent~     patients.~      For patients who initiate treatment with a cocaine-positive urine specimen, we will evaluate~     the efficacy of two CM procedures relative to standard, non-CM treatment. The two CM~     procedures will be provided as additions to standard care and will reinforce drug abstinence~     but will differ in expected magnitudes of prizes patients can earn, especially during early~     stages of abstinence. They will provide expected magnitudes of winning about $250 and $560,~     respectively. We expect that both CM conditions will improve retention and abstinence~     relative to the standard treatment, non-CM condition. If the enhanced CM condition engenders~     better outcomes than the $250 CM condition, this finding would suggest that patients~     initiating treatment while actively using cocaine may best be treated with relatively high~     reinforcement prize CM as an adjunct to standard care.~      For patients who initiate treatment with a cocaine-negative urine specimen, we will evaluate~     the efficacy of a CM procedure that reinforces treatment attendance. The expected magnitude~     of winnings will be about $250, and again CM treatment will be in addition to standard care.~     This CM condition will be compared to standard treatment without CM as well as to a CM~     treatment that provides a similar magnitude of reinforcement, but contingent upon abstinence.~     Results from this study will inform an important clinical question of whether simply~     reinforcing attendance can improve clinical outcomes. Increased retention may result in~     greater exposure to therapeutic processes that may reduce drug use, especially among patients~     who begin treatment having already achieved some abstinence. We will also evaluate the~     cost-effectiveness of CM by examining the effects of the interventions on hospitalizations,~     medical and psychiatric care, criminal justice costs, and productivity.~   "
225467|NCT00606840|"~     The specific aim of the proposed project is to test two separate self-regulation~     interventions to prevent weight gain in young adults, one based on making sustained small~     changes in behavior to prevent weight gain and the other on making periodic larger behavior~     changes resulting in weight loss.~   "
225468|NCT00606827|"~     Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal~     failure. Hydration with sodium bicarbonate is more protective than isotonic saline in~     animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate~     versus isotonic saline to prevent CIN in a large population of patients with renal~     dysfunction undergoing coronary angiography or intervention.~   "
225469|NCT00606814|"~     This study is a Phase I clinical trial of IPI-504 in combination with docetaxel~     (Taxotere).The purposes of the study are to determine:~        -  the safety profile,~        -  the highest dose of IPI-504 that can be given with docetaxel without causing severe side~          effects, and~        -  to recommend a Phase II dose of the combination in patients with solid tumors.~   "
225470|NCT00606801|"~     To evaluate galantamine's effects on cognitive performance in abstinent cocaine users.~     Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine~     esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these~     effects may result in improved cognitive performance in a group of subjects known to have~     impaired performance in various cognitive tasks.~   "
225471|NCT00606788|"~     The purpose of this study was to determine whether computer-driven protocolized weaning is~     superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical~     intensive care unit (ICU) patients. The main hypothesis was that weaning duration differs~     between both methods. Secondary hypotheses were that reintubation rate, duration of~     mechanical ventilation, intensive care unit (ICU) length of stay and workload for physicians~     and nurses differ between both methods.~   "
225472|NCT00606775|"~     Purpose This cardiac dysfunction in patients with Duchenne muscular dystrophy is associated~     with minor cardiac damage as indicated by elevation of plasma cardiac troponin I (cTnI). The~     purpose of this study is to investigate whether the administration of Carvedilol can suppress~     the minor cardiac damage and prevent deterioration of cardiac function.~   "
225473|NCT00606762|"~     The physiological changes and postoperative pain are directly related with the degree of~     intra-abdominal pressure kept during the laparoscopy. The present study aims to examine~     difference between low pressure pneumoperitoneum (8 mm Hg)and High pressure pneumoperitoneum~     (12 mm Hg)during laparoscopic cholecystectomy in terms of pain, cardio-pulmonary function,~     arterial blood gas changes etc.~   "
225474|NCT00606749|"~     The purpose of this study is to determine whether KC706 is effective in the prevention and~     healing of blisters in patients with pemphigus vulgaris, while the patient remains on stable~     doses of corticosteroids and/or immunosuppressants.~   "
225475|NCT00606736|"~     The purpose of this study is to determine whether the occurrence of idiopathic right~     ventricular outflow tract(RVOT) arrhythmia is relative to sex hormone levels in different~     stages of female menstrual cycle~   "
225476|NCT00606723|"~     1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent~          to a matched unrelated donor in in a second complete remission of acute myeloid leukemia~          (AML).~        2. To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema)~          increases survival compared to a threshold derived from historical data~        3. To evaluate whether SCT from haploidentical donors for children having no matched donor~          will result in better survival with acceptable toxicity.~   "
225477|NCT00606710|"~     The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston~     Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE~     Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation~     lead (when available). An optional sub-study will also evaluate the clinical performance of~     the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.~   "
225478|NCT00606697|"~     Patients with Primary Insomnia will be treated with GW597599 and GR205171 to evaluate the~     efficacy in the sleep difficulties associated with insomnia~   "
225479|NCT00606684|"~     This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic~     Obstructive Pulmonary Disease (COPD)~   "
225529|NCT00606034|"~     Patients with Type 2 diabetes and severe insulin resistance with very large insulin~     requirements who have failed all previous insulin regimens using non-concentrated forms of~     insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular~     insulin)infused via insulin pump.~   "
225480|NCT00606671|"~     The scope of the study was to investigate different metabolic aspects that may lead to or are~     a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome~     (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and~     fat biopsies for investigation of gene expression of different cytokines associated with~     insulin resistance. We investigate the incretin hormones GIP and GLP-1. These two hormones~     play a central role in glycemic control, and diabetic subjects are known to have alterations~     in their incretin hormones. The incretin hormones have not previously been investigated in~     women with PCOS.~   "
225481|NCT00606658|"~     This pilot study will attempt to test the effects of this non-invasive procedure on a small~     sample of insomnia patients and also determine the feasibility of recruiting and retaining~     participants during the trial for such treatments in the United States.~   "
225482|NCT00606645|"~     An open-label, multi-dose, single-arm, Phase 1 dose escalation study of XmAb®2513 was~     conducted to define the MTD or recommended dose(s) for further study, to determine safety and~     tolerability, to characterize PK and immunogenicity, and to evaluate antitumor activity of~     XmAb2513 in patients with HL and ALCL (non-cutaneous) and who have received two or more prior~     therapeutic regimens. There will be no intra-patient dose escalation.~   "
225483|NCT00606632|"~     This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250~     PET/CT pre-surgical imaging in patients with operable renal masses.~   "
225484|NCT00606619|"~     The aim of this study is to determine whether early oral feeding after curative resection for~     gastric cancer would be tolerable and give an effect on the recovery.~   "
225485|NCT00606606|"~     Medications are the single most common form of treatment in the long-term care setting, and~     often represent the most efficacious (and cost-effective) therapeutic modality used in this~     clinical setting. However, the residents of nursing homes are at increased risk for~     experiencing adverse drug events. This risk is increased by the physiologic decline and~     pharmacologic changes that occur with aging, and also by the special clinical and social~     circumstances that characterize institutional long-term care. In a study funded by the~     National Institute on Aging (AG 14472), we have previously determined that adverse drug~     events are common and often preventable in the nursing home setting and that the more serious~     the adverse drug event, the more likely it is to be preventable. This study will test whether~     a computer-based clinical decision support system can lower the rate of adverse drug events~     (ADEs) and potential ADEs in the long-term care setting. The study design is a randomized~     trial based in the resident care units of two large long-term care facilities. Within each~     facility, half of the resident care units will be randomized to an intervention arm receiving~     the computer-based clinical decision support system which will display warnings, messages,~     and prompts based on resident and drug use characteristics; with over-rides by the prescriber~     required for some warnings. Rates of ADEs and potential ADEs will be tracked by the study's~     on-site clinical pharmacists prior to and during the intervention period. Rates will be~     compared between units receiving and not receiving the computer¬based clinical decision~     support system and to baseline, pre-intervention rates in the same units. We will track all~     project costs directly related to the development and installation of the computer-based~     clinical decision support system. We will also develop and test the sensitivity and~     specificity of a computerized adverse drug event monitor and assess the validity of a nursing~     home resident risk model developed in our prior study of adverse drug events in the nursing~     home setting.~   "
225486|NCT00606593|"~     A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and~     tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with~     primary insomnia.~   "
225487|NCT00606580|"~     This study will test the ability of the topical cream WR 279,396 to treat the skin lesions~     caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that~     contains paromomycin + gentamicin. This cream will be compared to the effect of a topical~     cream containing paromomycin alone and to a placebo cream that contains no antibiotics.~     Therefore, this study will have three groups of patients, and they will be assigned to one of~     these treatments randomly. The study will be carried out without the patient or the physician~     knowing which cream is being used for which patient. The goal is to determine if WR 279,396~     cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than~     paromomycin alone.~   "
225488|NCT00606567|"~     The purpose of this study is to determine if remote monitoring of implantable cardioverter~     defibrillators (ICD), compared with quarterly device interrogations in clinic, will improve~     patients' outcomes and satisfaction and will reduce health care costs.~   "
225489|NCT00606554|"~     The purpose of this study is to compare the efficacy of a computer-assisted ventilator~     weaning system (Drager Smartcare) to our current standard of care in the medical intensive~     care unit.~   "
225490|NCT00606541|"~     Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of~     quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2)~     continuation effects of quetiapine XR in preventing SAD relapse.~   "
225491|NCT00606528|"~     The main objective of this study is to assess whether a recently-developed bioassay for the~     protein FGL2 can be used to predict the progression and/or response to treatment of Hepatitis~     C Virus disease in patients with chronic HCV infection. The hypothesis is that increased~     levels of FGL2 and increased numbers of T regulatory cells are associated with a failure to~     respond to treatment.~   "
225492|NCT00606515|"~     The purpose of this study is to determine whether there is any difference of the~     pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in~     Chinese cancer patients with solid tumors.~   "
225493|NCT00606502|"~     The purpose of this clinical study is to determine the effectiveness (ability to provide~     beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when~     given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette~     smokers and who have received at least 1 prior treatment with a platinum drug (cisplatin or~     carboplatin)~   "
225494|NCT00606489|"~     The primary objective of this study of Caldolor administered to hospitalized adult and~     pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when~     compared to placebo when administered every 6 hours for at least 24 hours.~   "
225495|NCT00606476|"~     This is a multicenter, open-label, long-term extension study in male and female patients with~     mild to moderate Alzheimer's Disease (AD) who must have completed one of the following~     studies: AAB-001-201 or AAB-001-102. All patients enrolled in Study AAB-001-251 will receive~     infusions of AAB-001 (bapineuzumab), including patients randomized to placebo in Study 201~     and 102. Approximately 30 study sites in the US will be involved. Each patient's~     participation may vary from 3 months up to 84 months depending on the date of enrollment in~     this study.~      AAB-001 (bapineuzumab) is a humanized monoclonal antibody, which binds to and potentially~     clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly~     to the patient.~   "
225496|NCT00606463|"~     Irrigated catheter for ablation of isthmus-dependent atrial flutter~   "
225497|NCT00606450|"~     There is an unmet medical need for safe, effective oral therapy for moderate-to-severe~     psoriasis. CC-10004 will be evaluated in a controlled setting of a clinical study. The~     information obtained from the study will aid in the design of future clinical trials and to~     establish the safety and efficacy of CC-10004.~   "
225498|NCT00606437|"~     Results to date of umbilical cord blood transplantation in adult and fully mature adolescent~     patients are inferior to what is seen in children, due to a lower stem cell dosage in adults~     and a more toxic conditioning regimen. This phase 1 protocol will use a potentially less~     toxic bone marrow conditioning regimen, followed by infusion of a combined umbilical cord~     blood graft that will provide the patient with a higher stem cell dose than can be given with~     a single umbilical cord blood infusion. The subjects will be conditioned with a total body~     irradiation (TBI) 13.5 Gy and fludarabine. Following conditioning, up to two unrelated,~     partially matched umbilical cord blood grafts will be infused that will provide a minimum~     nucleated cell dose of 3 x 10e7/kg . The primary objective of this study is to measure the~     frequency of treatment-related toxicity and engraftment.~   "
225499|NCT00606424|"~     [F-18]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging. This trial~     is looking at the safety of [F-18]HX4.~      The Sponsor is seeking to determine if [F-18]HX4 may serve as a clinically useful hypoxia~     marker in diagnostic imaging, allowing the rational application of hypoxia related therapies~     to those patients most likely to benefit from them.~      Tumor hypoxia, a situation where tumor cells have been deprived of oxygen, caused cancer~     cells to become more resistant to the effects of radiotherapy and chemotherapy.~      A non-invasive study characterizing tumor hypoxia would facilitate the development of~     targeted therapies.~      The population to be studied consists of a total of ten (10) adult subjects, including, four~     normal volunteers and six cancer subjects, the latter with a confirmed diagnosis of head and~     neck cancer, as defined by the protocol eligibility criteria.~      The objectives of this exploratory study are to:~        -  Gain information on bio-distribution of [F-18]HX4, and to evaluate the PET images of~          [F-18]HX4 for resolution, signal to background ratio for both intermediate levels of~          oxygenation, and at extreme levels hypoxia~        -  Use this eIND in order to obtain the necessary information to file an IND application~          with the FDA. The information collected under this exploratory study will not be used~          for diagnostic purposes, to assess the subject's response to therapy, or for clinical~          management of the subject.~        -  Begin collection of baseline imaging data~        -  Collect [F-18]HX4 metabolism data~        -  Gain information to improve study design and the conduct of future trials~      This investigation will be conducted as an exploratory, open-label, non-randomized,~     uncontrolled, single center, safety study.~      The trial is expected to begin subject enrollment in early January 2008 and end subject~     participation in June 2008.~      The duration of an individual subject's participation includes a screening visit, followed by~     participation in the actual study starting with the day of dosing with imaging sessions~     lasting several hours, concluding with a next day safety follow-up visit.~      Individual doses of [F-18]HX4 shall not exceed 20 mCi. The IP will be administered through a~     previously placed suitably sized angiocatheter or a butterfly needle. Prior to injection,~     qualified site personnel will assay the dose. After IP administration several PET imaging~     series will be acquired. Also, in order to assess major organ function and electrolyte~     levels, a metabolites analysis will be performed for this study from predose to 90 minutes~     postdose.~      In order to determine the quantity of [F-18]HX4 and labeled metabolites excreted by the~     kidney,urine will be collected and pooled at the designated intervals after administration of~     the investigational product. This excretion data will provide supportive information for~     calculating human dosimetry estimates from PET imaging biodistribution data collected in~     human subjects.~      For cancer subjects, a tissue biopsy will have been taken or be scheduled to be performed.~     The biopsy sample will be examined for hypoxic biomarker(s) using immunohistochemistry~     methods.~   "
225500|NCT00606411|"~     The purpose of the study is to learn about the safety and effectiveness of oral (taken by~     mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).~   "
225501|NCT00606398|"~     This is a Phase II study of combined surgical resection for patients with both intra- and~     extra-hepatic metastases from colorectal cancer. The primary objective is to determine the~     two-year disease free survival (DFS) of patients who undergo surgical resection of both~     intra- and extra-hepatic metastases from colorectal cancer. The secondary objectives are to~     determine the overall survival rate (OS), patterns of treatment failure, treatment efficacy~     (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of~     life, and hospital length of stay.~   "
225502|NCT00606385|"~     Short-term outcomes of laparoscopic liver resection is better than those of open liver~     resection~      Laparoscopic liver resection is better than open resection in immunological aspects~   "
225503|NCT00606372|"~     Previous studies comparing on-pump and off-pump operating strategy did only partially~     demonstrate benefits of the off-pump myocardial revascularisation.In primary end-points (MI,~     death, renal failure, and so on) there was no significant difference, but in secondary~     end-points we observed benefits resulting for patients. We would like to show the benefit of~     the method without extracorporeal circulation in patients with higher and hight operation~     risk, coming from EuroSCORE classification system (6 points and more).~   "
225504|NCT00606359|"~     Primary Objective:~      To describe the immunogenicity of an injection of the investigational inactivated,~     split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal~     transplant subjects identified as non-responder to previous vaccination with the IM reference~     vaccine (Vaxigrip®).~      Secondary Objective:~      To describe the safety of an injection of the investigational inactivated, split-virion~     influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder~     to previous vaccination with the IM reference vaccine~   "
225505|NCT00606346|"~     The purpose of this study is to evaluate the long-term safety and clinical status of~     pediatric patients with Inflammatory Bowel Disease (IBD). Particular attention will be~     directed to recording safety outcomes reported in association with infliximab and other~     prescribed IBD therapies. In addition, information on disease status and quality of life will~     be collected.~   "
225506|NCT00606333|"~     The purpose of this study is to evaluate the safety and effectiveness of the Conor~     Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single~     atherosclerotic lesion) in native coronary arteries. The study will evaluate the outcomes of~     a new drug-eluting stent compared to an approved drug-eluting stent.~      While Cordis made a business decision to no longer pursue NEVO™ development and~     commercialization, the patients will be followed up as per protocol. This includes performing~     all protocol required follow-up visits and the collection and reporting of all safety~     information.~   "
225507|NCT00606320|"~     To assess the safety and efficacy of long-term administration of aripiprazole by performing~     extended administration of aripiprazole in combination with mood stabilizer (lithium or~     valproate) in an unblinded manner to those patients who completed the preceding multicenter,~     double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients~     with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter~     Study 003) but whose condition worsened or remained unchanged or who discontinued Study 003~     between Day 14 and Day 21 due to lack of drug efficacy.~   "
225508|NCT00606307|"~     In recent years several reports have documented that Histone Deacetylases (HDACs) inhibitors~     induce neoplastic cells to undergo growth arrest, differentiation and/or apoptotic cell~     death. Recently, inhibitors of HDACs has also been shown to inhibit endothelial cell~     proliferation and angiogenesis in vivo. Several HDAC-inhibitors are currently in clinical~     trials as novel anticancer agents. Among these agents, ITF2357 has most recently been shown~     to be a potent inhibitor of the autonomous proliferation of haematopoietic cells from~     patients with myeloproliferative disorders carrying the JAK2 V617F mutation. The aim of the~     present study is to evaluate the efficacy and safety of ITF2357 in the treatment of~     polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)~   "
225509|NCT00606294|"~     The main purpose of this study is to evaluate low oxygen areas called hypoxia within tumors.~     These low oxygen areas are thought to be the reason why tumors are more resistant to~     chemotherapy and radiation treatment.~      An imaging technique using a hypoxia tracer called fluoromisonidazole (FMISO) can detect low~     oxygen areas within a tumor. This imaging technique, called a PET scan, uses positively~     charged particles to detect slight changes in the body's biochemistry and metabolism. FMISO~     PET scans have been performed in patients with head and neck cancer and have shown the~     ability to detect low oxygen areas within tumors.~   "
225510|NCT00606281|"~     The primary objective of this trial is to evaluate the clinical efficacy and safety of~     aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a~     manic or mixed episode.~   "
225511|NCT00606268|"~     The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal~     prophylaxis in children and adolescents undergoing HSCT~   "
225512|NCT00606255|"~     Study Rational:~      In general, chronic disease without symptoms such as hypertension, the treatment compliance~     is relative low and is difficult to increase. The low compliance is related to poor~     prognosis. There are many factors that effect to compliance of antihypertensive drug.~     Education is one factor that can be controlled by doctors. Therefore, in this study, the~     compliance of the patients in 3 groups of active training group, passive training group, and~     no training group (usual treatment group) will be compared to evaluate the effect of training~     for controlling of hypertension.~   "
225513|NCT00606242|"~     This study investigates the effect of a inhaled corticosteroid (fluticasone or Flovent) on~     airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that~     fluticasone will be more effective in preventing saline-induced airway narrowing than~     methacholine-induced narrowing.~   "
225514|NCT00606229|"~     To assess the safety and efficacy of long-term administration of aripiprazole in combination~     with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I~     Disorder experiencing a manic or mixed episode~   "
225515|NCT00606216|"~     The purpose of this study is to learn about possible changes in brain anatomy and in thinking~     abilities, such as memory skills, in patients with cancer who receive treatment with~     chemotherapy alone or in combination with total body radiation before undergoing stem cell~     transplantation.~   "
225516|NCT00606203|"~     Depression is one of the important psychiatric sequelae after stroke. The prevalence of post~     stroke depression (PSD) is approximately 20-40%. Depression comorbid with stroke has been~     found to be associated with increased disability, cognitive function decline, poorer~     rehabilitation outcome and higher mortality rate.We are going to conduct a trial of~     prevention of psot stroke depression by prescribing milnacipran in advance.~   "
225517|NCT00606190|"~     The purpose of this research study is to evaluate two standard approaches of supplying blood~     and oxygen to your brain during open heart surgery.~   "
225518|NCT00606177|"~     To investigate the safety and efficacy of long-term administration of aripiprazole by~     performing extended administration of the treatment administered in the preceding~     multicenter, double-blind, placebo-controlled, parallel group-comparison trial of~     aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study~     031-06-003, hereafter Study 003) in a double-blind manner to those patients who complete~     Study 003 and demonstrate drug efficacy.~   "
225519|NCT00606164|"~     The main purpose of this study is find out how safe a single dose of bryostatin 1 is in~     patients with Alzheimer's Disease (AD). This study is also being done 1) to determine how~     effective a single dose of bryostatin 1 is in the treatment of AD, 2) to find out what~     happens to bryostatin 1 once it enters the body by measuring the levels of bryostatin 1 in~     blood, and 3) to measure a substance in the blood (protein kinase C) that may help to better~     understand how bryostatin 1 works.~   "
225520|NCT00606151|"~     The purpose of this study is to determine if an intravenous (IV) antiplatelet medication is~     as safe and effective at preventing clot formation in your stented artery as compared in~     people who have stopped clopidogrel prior to surgery.~   "
225521|NCT00606138|"~     Diabetic neovascularization refers to a type of diabetic retinopathy which is worsening by~     the abnormal growth of blood vessels in the back of the eye, damaging the retina. The usual~     treatment is a type of laser, called panretinal photocoagulation. One drawback is that the~     amount of space within the eye for use of this treatment eventually has its limit, and should~     not be used too near the part of the retina used for detailed vision (the macula). In similar~     eye disorders, there are certain injectable medications called anti-VEGF treatments which can~     slow down or stop this abnormal blood vessel growth. This study sought to compare use of~     ranibizumab versus standard panretinal photocoagulation in treatment of diabetic~     neovascularization.~   "
225522|NCT00606125|"~     The purpose of this study is to:~        1. Evaluate how the body reacts to sorafenib when taken daily in combination with~          paclitaxel and carboplatin,~        2. Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times~          after taking the medication, and~        3. To determine the safety of sorafenib.~   "
225523|NCT00606112|"~     The purpose of this study is to evaluate the safety and tolerance of a single intravenous~     (through a vein) dose of trodusquemine (MSI-1436) in obese, type 2 diabetics.~      Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group~     throughout the study.~      Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug~     enters and leaves the blood and tissues over time) of trodusquemine (MSI-1436).~      Finally, this study will also determine whether trodusquemine (MSI-1436) has any effect on~     appetite, mood or behavior, and selective biomarkers (substances in your blood that may~     change in response to the study drug).~   "
225524|NCT00606099|"~     This study is designed to evaluate the efficacy and safety of telbivudine 600mg versus~     adefovir dipivoxil 10mg in patients with compensated chronic hepatitis B.~   "
225525|NCT00606086|"~     The GI-5005 therapeutic vaccine in combination with standard of care or standard of care~     alone will be injected under the skin of HCV subjects. Patients will be monitored for safety,~     immune responses and any therapeutic benefits related to the injections including EVR, ETR,~     and SVR.~   "
225526|NCT00606073|"~     The aim of this study is to examine whether incubation of human oocytes until pronuclear~     stage, in different culture media containing high and low concentrations of glucose affect~     fertilization differently, not only in standard IVF cycles, but also after intracytoplasmatic~     sperm injection.In addition, we wish to determine whether exposure of oocytes to different~     concentrations of glucose until pronuclear stage has further effect on embryo quality and~     development until the blastocyst stage.~   "
225527|NCT00606060|"~     Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in~     the treatment of patients with hemophilia A undergoing major elective surgery by achieving~     the required therapeutic concentrations.~   "
225528|NCT00606047|"~     Femoroacetabular hip impingement syndrome is a newly recognized cause of early arthritis of~     the hip. In this condition a variation in the shape of the upper thigh bone causes it to~     repeatedly come in contact with the hip socket leading to cartilage damage and arthritis. The~     purpose of this study is to investigate whether patients without hip pain have variations at~     the hip joint such as those seen in hip impingement syndrome.~   "
225530|NCT00606021|"~     This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed~     plus best supportive care with best supportive care alone as maintenance therapy following~     first-line treatment with a pemetrexed-cisplatin combination in patients with advanced~     non-squamous non-small cell lung cancer.~      A total of approximately 100 patients are planned to be enrolled, and following completion of~     four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease~     progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms~     (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive~     care alone).~   "
225531|NCT00606008|"~     We are asked patients to take part in this study because they had recurrent (returned) (1st~     or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).~      The purposes of this study are:~        -  To see if Sutent has any change on the patient and their cancer.~        -  To see if Sutent will slow or stop the growth of their tumor.~        -  To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved~          to treat patients with a gastrointestinal stromal tumor after the disease worsened while~          taking another medicine called imatinib mesylate or when imatinib mesylate cannot be~          taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma.~          At this time, it is not known whether Sutent will improve symptoms, or help patients~          with this disease live longer.~   "
225532|NCT00605995|"~     The overall purpose of this study is to determine whether the cholesterol-lowering drug~     simvastatin is effective in the treatment of symptoms of schizophrenia. The primary~     hypothesis is that patients with schizophrenia receiving add-on treatment with simvastatin~     will improve clinically (as measured mainly by symptom severity) compared with patients~     receiving placebo, and that this improvement will be accompanied by concomitant reduction in~     peripheral inflammatory markers.~   "
225533|NCT00605982|"~     Breast MRI is a fairly new technology, but it has been well studied. It is now used routinely~     in many patients with breast cancer. It has been shown to be useful in detecting areas of~     cancer that cannot be seen using other types of scans or tests.~      The purpose of this study is to see how often MRI can find other areas of cancer in women~     with one area of breast cancer, and to determine how having the MRI test affects their~     treatment. The purpose is also to study any areas of abnormality seen on your MRI with~     special methods that allow the images of your breast tissue and the microscopic analysis of~     your breast tissue to be compared very carefully. The study also aims to follow women who~     enter the study over a 10-year period to determine how often the breast cancer comes back.~   "
225534|NCT00605969|"~     One of the leading causes of hip arthritis is femoro-acetabular impingement which means the~     hip joint is deformed such that the hip joint jams in the front when the hip is bent all the~     way forward. This can lead to significant damage to the hip joint and may result in the need~     for a total hip replacement. However, if detected early, this deformity can be treated~     surgically by reshaping the hip joint. If the hip joint could be better visualized before~     surgery, then surgeons would be able to develop less invasive surgical techniques to correct~     this deformity.~      In this study, we are trying to develop a way to help surgeons visualize the hip joint before~     surgery in order to assist with pre-operative planning. This will be done by comparing the~     dynamic hip images in patients with femoro-acetabular impingement to the hip images of~     healthy volunteers with no hip problems.~   "
225535|NCT00605956|"~     Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity~     response that requires the presence of ultraviolet irradiation. The predictive procedure is,~     therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate~     sets of patches of test articles are used with exposure of only one set to UV radiation and~     subsequent evaluation of both sets for skin reactions in order to compare irradiated versus~     non-irradiated test sites.~   "
225536|NCT00605943|"~     This study will measure antibody levels in the blood of people with bleeding or swelling in~     the retina who have or have not been treated with bevacizumab (Avastin[Trademark]or~     ranibizumab (Lucentis[Trademark]). These drugs have been useful in reducing retinal bleeding~     and swelling in people with eye diseases that cause these symptoms, but the drugs' effects~     usually wear off and they have to be given repeatedly. In some patients, the benefits become~     less and less. It is possible that over time, patients taking these drugs may produce~     antibodies that act against the drugs, thus neutralizing their effects and preventing them~     from working properly.~      People 18 year of age and older who are participating in a current NEI protocol and meet the~     following criteria may be eligible for this study:~        -  Are receiving injections of bevacizumab or ranibizumab for bleeding or swelling in the~          retina, but the treatment is becoming less effective~        -  Are receiving injections of bevacizumab or ranibizumab for bleeding or swelling in the~          retina and the treatment is still effective~        -  Have bleeding or swelling in the retina, but have never received either bevacizumab or~          ranibizumab~      Participants have blood samples drawn once when they start the study, once in the middle of~     the study, and once at the end of the study. They are asked permission for study researchers~     to review the results of their eye examinations at NIH.~   "
225537|NCT00605930|"~     This study intends to study the safety and tolerance of the combination of pyruvate,~     creatine, and niacinamide over 6 months in patients with PSP.~   "
225538|NCT00605917|"~     The objective of this surveillance is to collect information for panic disorder patients~     about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions),~     2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to~     affect the safety and/or efficacy of this drug.~   "
225579|NCT00605345|"~     This two arm study will compare the efficacy and safety of subcutaneous Mircera versus~     darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients~     with chronic renal anemia. Patients currently receiving maintenance treatment with~     darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a~     starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of~     darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on~     2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months,~     and the target sample size is 100-500 individuals.~   "
225580|NCT00605332|"~     This is an open label, non-randomized, prospective, multicenter study.~   "
225539|NCT00605904|"~     This study will determine if acamprosate, a drug approved to treat alcoholism, decreases~     alcohol cravings in alcohol-dependent subjects following infusions of yohimbine and mCPP.~     Yohimbine causes anxiety and may provoke a desire for alcohol; mCPP induces a feeling of~     having had a few drinks, which often creates a desire for more drinks. If acamprosate can~     prevent a craving following these stimuli, then the effectiveness of new experimental drugs~     for treating alcoholism can be tested for their ability to block yohimbine or mCPP-induced~     cravings. This type of investigation would be less expensive and less time-consuming than~     conducting clinical trials with alcohol-dependent people.~      People between 21 and 65 years of age who are alcohol-dependent and have been drinking~     regularly for at least 1 month before entering the study may be eligible to participate.~      Participants are admitted to the NIH Clinical Center for about 35 days, during which time~     they are asked to participate in an alcohol treatment program. They may request passes to~     leave the hospital during the day but must return overnight. Upon return to the hospital,~     subjects are required to take a breathalyzer test for alcohol and urine screen for drug use.~     Participants found to have used drugs or consumed alcohol while away from the hospital are~     terminated from the study.~      Participants are randomly assigned to take acamprosate or placebo pills three times a day for~     about 2 weeks. They are then given three intravenous (through a vein) infusions, 5 to 7 days~     apart, each containing either yohimbine, mCPP or placebo. The drugs are infused for 20~     minutes following a 1-hour infusion of saline (salt water). Subjects complete two~     questionnaires - an alcohol urge questionnaire to assess the desire for alcohol and a PASS~     rating scale to assess anxiety - several times during the study and during the infusions....~   "
225540|NCT00605891|"~     The purpose of this study is to identify the optimal once-daily dose of CHF 4226 to be~     further developed for the treatment of patients with COPD.~   "
225541|NCT00605878|"~     This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and~     how microbes contribute to health and disease. It will analyze healthy human skin and how the~     these microorganisms might change in patients with atopic dermatitis (AD), a skin condition~     also known as eczema.~      Healthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40~     years of age may be eligible for this study.~      We also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited~     immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich~     syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to~     AD.~      Eligible participants undergo the following tests and procedures:~        -  Medical family and medication history~        -  Skin examination~        -  Blood tests (research blood as well as serum IgE, and complete blood count)~        -  Skin samples to analyze microbes. Samples are obtained by the following methods:~          swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade~          to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal)~          of a small skin sample less than 1/4-inch (5 mm) in diameter.~        -  Nose swabs to analyze microbes.~        -  Patients with eczema may have photographs of their skin taken to help monitor the skin~          rashes.~      Participants may be contacted periodically for follow-up studies. Patients with atopic~     dermatitis may have additional skin samples collected to examine changes in the skin bacteria~     over time and during all of the stages of eczema. In addition, patients who have a flare of~     their eczema are asked to undergo a skin sample collection as soon as possible.~   "
225542|NCT00605865|"~     The objective of this surveillance is to collect information about 1) adverse drug reactions~     not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug~     reactions in this surveillance, and 3) factors considered to affect the safety and/or~     efficacy of this drug.~   "
225543|NCT00605852|"~     This study is designed to assess the safety and tolerability of single, escalating oral doses~     and repeat oral doses (7 days, once daily) of GSK835726 in healthy male subjects~   "
225544|NCT00605839|"~     Among those with type I diabetes, adolescents can be among the worst at achieving glycemic~     control. Behaviors normal in adolescent development (e.g., developing independence, rejecting~     parental norms in favor of peers) can be at odds with the demands of effective diabetes~     self-management. Modifying the family and patient interaction should be a crucial component~     to improving the ability of an adolescent to manage his or her diabetes.~      Mobile technology is becoming more popular in medicine, and adolescents, as a group are more~     inclined to accept technology as an adjunct to care. Mobile technology that links adolescents~     to health providers could help them to work through complex information that must be~     processed to make good decisions. Since this assistance comes from health professionals, it~     should help relax parents somewhat, thus reducing problems associated with parental~     hypervigilance and manipulation of the regimen to avoid problems of hypoglycemia.~     Parental-child conflicts may therefore be reduced by using cell phone glucose monitoring~     technology that directly reports self-blood glucose monitoring data to providers and creates~     a communication link to discuss therapeutic options.~      This study investigates whether the use of mobile technology, in the form of a cell phone~     glucose monitoring system, will help reduce the need for parents to assert behavioral~     control, which can negatively impact adolescent diabetes self-management. The study will also~     determine whether adolescents report improved quality of life, demonstrate competence in~     diabetes management, and are able to achieve better control of their diabetes.~   "
225545|NCT00605826|"~     The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used~     as an injectable bulking agent in the treatment of fecal incontinence. The study includes a~     6-month blinded sham-controlled phase, followed by an open-label phase.~   "
225546|NCT00605813|"~     Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety.~     The objective of this Special investigation is to collect information about 1) adverse drug~     reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of~     adverse drug reactions in this surveillance, and 3) factors considered to affect the safety~     and/or efficacy of this drug regarding long time use.~   "
225581|NCT00605319|"~     The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency~     with or without the inability to hold your urine until you get to the toilet) are invited to~     participate in this research study.~   "
225582|NCT00605306|"~     This study will investigate the safety and tolerability of indacaterol maleate/mometasone~     furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate~     asthma.~   "
225583|NCT00605293|"~     This 2 arm study will compare the efficacy and safety of monthly administration of~     intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in~     hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance~     treatment with epoetin alfa will be randomized either to receive monthly injections of 120,~     200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa~     they were receiving in the week preceding study start, or to continue on epoetin alfa~     treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146~     participants.~   "
225547|NCT00605800|"~     The results of this study may or may not establish useful baseline data, which will help us~     understand how bone marrow derived adult liver stem cells behave in normal healthy~     adults/volunteers (the control group), and in patients undergoing liver surgery. The bone~     marrow is located within your bones and is the organ which is responsible to produce blood~     cells and stem cells. Bone marrow derived adult liver stem cells are normal cells in your~     bone marrow. These liver stem cells have the capacity to regenerate or in other words to~     rebuild the liver after liver surgery, a process called liver regeneration. These cells are~     very important for the liver to regrow its tissue after liver surgery. These cells are~     thought to be activated in times of need by the liver.~      Situations like liver surgery are one of these occasions when the liver will need the extra~     help from these stem cells.~      The results of this study will establish the baseline data necessary for the understanding of~     how to harness the ability of these stem cells in times of liver surgery. Improvements in the~     ability of the liver to regrow after surgery is thought to decrease complications related to~     liver surgery. Harnessing this unique ability of stem cells may be utilized in the future to~     enhance the regrowing process of liver tissue after liver surgery, called liver regeneration.~   "
225548|NCT00605787|"~     The aim of the study is to evaluate the short-term effects of tetradecylthioacetic acid (TTA)~     on plasma lipids and glucose in male patients with type 2 diabetes mellitus and dyslipidemia~   "
225549|NCT00605774|"~     When a patient with Type 1 diabetes exercises, he or she is more prone to low blood sugar, or~     hypoglycemia. It is known that antecedent exercise can blunt defense responses, called~     counterregulatory responses to subsequent hypoglycemia in Type 1 DM, causing him or her to be~     vulnerable to another bout of hypoglycemia. Epinephrine is one of the important hormones in~     the defense of blood glucose during both exercise and hypoglycemia. We will test the~     hypothesis that antecedent exercise will blunt the metabolic, neuroendocrine and~     cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.~   "
225550|NCT00605761|"~     Subject with Cystic Fibrosis have increased clearance of many drugs. Based on pre-clinical~     data SB656933 was found to have low clearance and high bio-availability. This study will~     characterize the PK profile of a single dose of SB656933 in patients with Cystic Fibrosis.~     There will be two groups of subjects. The first group of subjects will receive a single dose~     of 50mg SB-656933. The second group of subjects will receive a single dose of up to 300 mg~     SB-656933. Subjects will first be screened for eligibility related to cystic fibrosis~     history. Safety evaluations will be undertaken and plasma samples for pharmacokinetic~     analysis will be collected. Additional blood samples will be taken for the pharmacodynamic~     endpoints CD11b and GAFS. Subjects are not required to stay overnight after their 12 hour PK~     sample collection on Day 1, although they may do so if they wish. On Day 2 and 3, they will~     return for collection of additional safety measurements, and further plasma and blood samples~     will be taken for 24 and 48 h pharmacokinetics and 24h CD11b/GAFS measurements, respectively.~      A follow up visit (Visit 3) will be made 4-7 days after the treatment period. Subjects will~     be enrolled in the study for approximately 3to 7 weeks (from screening to follow-up).~   "
225551|NCT00605748|"~     We conduct a randomized study comparing the safety and effectiveness of two interventional~     ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary~     vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental~     Isolation of the arrhythmogenic pulmonary vein(s)~   "
225552|NCT00605735|"~     The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be~     more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis~     who are also taking methotrexate~   "
225553|NCT00605722|"~     This single arm study evaluated the efficacy and safety of a combination of Tarceva and~     Avastin in patients with advanced or metastatic liver cancer. Patients were treated with~     Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks. The anticipated~     time on study treatment was until disease progression, and the target sample size was <100~     individuals.~   "
225554|NCT00605709|"~     The purpose of this study is to determine the safety and tolerability of pharmaceutical~     compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma~     and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell~     carcinoma by Compound 31510 topical cream.~   "
225555|NCT00605696|"~     Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition~     that causes respiratory failure. Symptoms usually develop within 24 to 48 hours of an~     original injury or illness, and people with ALI/ARDS typically require care in the intensive~     care unit (ICU). Little is known about how to prevent the onset of ALI/ARDS. The purpose of~     this study is to examine if early infusions of insulin, known as intensive insulin therapy~     (IIT), can help prevent ALI/ARDS in hospitalized patients with high levels of blood sugars~     and severe infections.~   "
225556|NCT00605683|"~     Parkinson's disease is a major neurodegenerative disorder in which there is a progressive~     loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of~     dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a~     precursor of DA that crosses the blood brain barrier, and also to the use of selective~     inhibitors of MAO B, the major DA metabolising enzyme in man.~      This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi~     national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.)~     versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects~     with early idiopathic Parkinson's Disease.~      The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score~     from baseline to endpoint, was chosen based on regulatory guidance and prior use in other~     trials in similar populations.~   "
225557|NCT00605670|"~     The goal of this study is to develop a questionnaire to measure patient satisfaction with~     their breast surgery. This questionnaire will help surgeons better understand how patients~     feel about their surgical results. We hope that such a questionnaire will improve the~     understanding of breast surgery results and patient care.~   "
225584|NCT00605280|"~     The purpose of the study is to test whether Macugen injected into the eye improves vision in~     more patients than the currently existing standard of care laser therapy. The safety of~     Macugen compared to standard of care laser will also be evaluated.~   "
244755|NCT00350311|"~     This study is a feasibility study of a multi-component intervention to enhance healthy living~     among young people with psychotic disorders, specifically targeting smoking and weight.~   "
225558|NCT00605657|"~     This study will test whether valproic acid (Depakote[Registered Trademark]) can shrink~     enlarged lymph glands and spleen in patients with autoimmune lymphoproliferative syndrome~     (ALPS). Depakote has been used for more than 30 years for treating various medical disorders~     in adults and children, including migraine headaches, seizures and psychiatric disorders. In~     animal studies, it was effective in shrinking both lymph nodes and spleen in animals with~     conditions similar to ALPS.~      People with ALPS who are between 2 and 70 years of age and who have had an enlarged spleen or~     lymph glands for at least 1 year may be eligible for this study.~      Participants take Depakote as a tablet or liquid or sprinkled on food twice a day for 16~     weeks. The drug dose is increased slowly over the first 3 to 4 weeks until the maximum~     tolerated dose is reached. Blood tests are done at 2, 4, 6, 8 and 10 weeks after starting the~     drug and 1 week after the drug is stopped to check for treatment side effects. Valproic acid~     blood levels will be checked during drug escalation, half way through therapy, and just~     before the end of treatment. A physical examination and CT scan (or ultrasound of the abdomen~     for patients who cannot undergo CT) are done before starting treatment and at the end of the~     16-week treatment period to evaluate the response to treatment.~      Patients who tolerate the treatment well and show shrinkage of the lymph glands or spleen may~     be offered extended treatment for up to 1 year in consultation with their primary physician.~     During the extended treatment period, blood tests are done at home every 6 to 8 weeks to~     monitor for drug side effects. Follow up evaluation visits are scheduled at the NIH Clinical~     Center every 3 months during the extended treatment period and 3, 6, and 12 months after~     treatment has ended.~   "
225559|NCT00605644|"~     The primary purpose of this study is to evaluate the safety and dose-response relationship of~     N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects~     administered MOA-728 who have chronic pain that is not due to cancer, and who have~     opioid-induced bowel dysfunction (OIBD).~   "
225560|NCT00605631|"~     This study is designed to evaluate the effect of pacing on post-MI patients.~   "
225561|NCT00605618|"~     Part A: The purpose of this study is to find the maximum tolerated dose of BMS-777607 in~     subjects with advanced or metastatic solid tumors~      Part B: The purpose of this study is to describe the preliminary activity of BMS-77607 in~     subjects with advanced or metastatic gastroesophageal cancer, hormone refractory prostate~     cancer, head and neck squamous cell carcinoma, and type I papillary renal cell carcinoma~   "
225562|NCT00605605|"~     To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular~     protection effect on heavy smokers.~   "
225563|NCT00605592|"~     This protocol will provide islet cell transplantation to two separate populations in need of~     a pancreas transplant:~      Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems~      Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney~     Transplant~      The targeted patients have very brittle diabetes or dangerous hypoglycemic unawareness and~     may benefit from transplantation over continuing insulin therapy, even though chronic~     immunosuppression is required. We believe that in these patients, the islet transplant~     procedure promises enough potential benefit to justify subjecting patients who have not~     previously had a transplant to the risk of immunosuppression.~      In patients who are already subject to the dangers of chronic immunosuppression for other~     reasons, i.e. to prevent rejection of a kidney allograft, the islet transplantation procedure~     itself is the principal additional risk and this risk should be minimal. In these patients~     (our Group II), the potential benefit from improved glycemic control is that it promises to~     slow or even reverse diabetic complications, such as vascular problems leading to kidney~     damage. It is this rationale that has made pancreas transplantation a widely accepted option~     in patients with renal failure, despite the risks associated with whole pancreas~     transplantation. Islet cell transplantation aims to provide a potentially lower risk~     procedure that has similar relief from diabetic complications.~   "
225564|NCT00605566|"~     This is a phase II clinical trial to assess the efficacy of the combination of metronomic~     cyclophosphamide and tailored sorafenib dosing in advanced, progressive NET. NET are highly~     vascular tumors, and high VEGF expression has been correlated with worse clinical and~     pathological characteristics as well as poor prognosis. A novel antiangiogenic approach~     relies on targeting not only the endothelial cells but also rendering them more sensitive to~     VEGFR blockade by achieving pericyte detachment. In this study, the dose of sorafenib will be~     titrated up to a maximum of 800mg BID based on patients' toxicity and on a novel~     pharmacodynamic assay that measures inhibition of molecular target(PDGFR) in patients'~     peripheral blood mononuclear cells. Dual VEGFR targeting is achieved by administering~     sorafenib plus metronomic low dose cyclophosphamide.~   "
225565|NCT00605553|"~     This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as~     measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a~     function test is administered.~   "
225566|NCT00605540|"~     The study aim is to verify the association between the changes in markers of disease and~     patient´s prognosis in chronic obstructive pulmonary disease.~   "
225567|NCT00605527|"~     Acute lung injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) is a severe lung condition~     that causes respiratory failure. This study will examine if differences in genes and~     biomarkers involved in the blood clotting process may affect the severity of and recovery~     from ALI/ARDS in children hospitalized with the condition.~   "
225585|NCT00605267|"~     The purpose of this multi-centre, randomised, double-blind, parallel-group study is to~     compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative~     administration under goserelin acetate treatment for premenopausal breast cancer patients~   "
225622|NCT00604773|"~     The objective of this study is to determine the incidence of delirium in adults patients who~     are admitted at the critical care unit of a Dutch University Hospital.~      The primary aim is to determine the incidence of delirium and to determine risk factors for~     this group of patients to develop a prediction model.~      A secondary aim is to find differences between delirious patients and non-delirious patients~     on different aspects of diagnostics, treatment and care, outcome, length of stay, and~     inflammation.~      According to Dutch law, the need to obtain informed consent was waived by the Committee on~     Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).~   "
225568|NCT00605514|"~     This study will determine if experimental vaccines to prevent Ebola virus infection and~     Marburg virus infection are safe and what side effects, if any, they cause. Ebola virus~     infection may range from mild to severe, and may cause breathing problems, severe bleeding,~     kidney problems and shock that can lead to death. Marburg virus infection causes an illness~     similar to that caused by the Ebola virus. The vaccines used in this study contain genetic~     material produced in the laboratory that causes the body to make a small amount of either~     Ebola or Marburg virus proteins. No Ebola or Marburg virus is in the vaccines.~      Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.~      Participants are assigned to receive injections of either the Marburg or the Ebola vaccine.~     The first group of participants will receive the Marburg vaccine and the second group will~     receive the Ebola vaccine. The injections are given at 4-week intervals (study weeks 0, 4 and~     8). They are given into a muscle with a needleless system called the Biojector(Registered~     Trademark) 2000.~      Participants keep a diary at home (on paper or electronically) for 5 days, in which they~     record their temperature, symptoms and any reaction at the injection site. They call a study~     nurse the day after vaccination to report how they feel and return to the clinic for~     follow-up 2 weeks after each injection (weeks 2, 6 and 10). The visits include a check of~     vital signs, blood and urine tests, medical history and review of medications taken.~     Additional visits at weeks 12, 24 and 32 include a check of vital signs, medical history and~     blood tests.~   "
225569|NCT00605488|"~     See where the dye-like material (FACBC) goes in your body and how long it stays in your body.~     See how much of the dye-like material is picked up by your tumor Compare the FACBC pictures~     with other pictures (such as FDG PET scan) that were obtained as part of your standard~     imaging evaluation.~   "
225570|NCT00605475|"~     The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether~     Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose~     levels in response to an oral glucose tolerance test (OGTT).~   "
225571|NCT00605449|"~     This study is a 3-period crossover drug interaction study between GSK376501 and simvastatin~     in healthy adult subjects. This study will examine if repeat doses of GSK376501 affects the~     pharmacokinetics of simvastatin and if repeat doses of simvastatin affects the~     pharmacokinetics of GSK375601.~   "
225572|NCT00605436|"~     We tested the following hypotheses:~        1. That a standardized yoga therapy will improve insulin sensitivity (primary outcome), and~          other features of the metabolic syndrome such as hypertension and dyslipidemia~          (secondary outcomes), we will perform a 2-hour oral glucose tolerance test, fasting~          blood tests, and a physical examination before and after randomization of subjects to a~          10-week yoga therapy intervention or wait-list control group.~        2. That a yoga therapy is feasible in overweight and underactive individuals with the~          metabolic syndrome, that adherence to a yoga intervention is acceptable, and that yoga~          therapy is associated with improved quality of life, we will assess the adherence to~          twice-weekly yoga group sessions (for weeks1-5) and weekly yoga group sessions (for~          weeks 6-10), frequency of home yoga therapy practice, and self-reported quality of life~          before and after the intervention in both treatment groups.~        3. To elucidate a potential mechanism for the effect of yoga on changes in insulin~          resistance by evaluating markers of inflammation from adipose tissue (adipocytokines).~          We hypothesize that these biochemical parameters will show modest improvement with yoga~          therapy and that changes in these parameters will be associated with improvements in~          insulin sensitivity.~   "
225573|NCT00605423|"~     Treatment of exudative age-related macular degeneration has been significantly improved by~     the advent of Lucentis™( which provides improved vision rather than simply stabilization) is~     common; however, monthly injections may be required to maintain this effect. It is~     hypothesized that sustained release fluocinolone acetonide will allow maintenance of the~     improved vision with fewer Lucentis injections.~   "
225574|NCT00605410|"~     Certain lung disease medications can influence diagnostic tests and research investigations.~     This study will investigate how long ipratropium bromide must be withheld before a~     methacholine challenge test can be conducted. This information will be useful for validating~     current guidelines.~   "
225575|NCT00605397|"~     The purpose of this study is to learn more about how a new study agent works inside the body.~     The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was~     developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small~     amount of radioactive dye that follows something else that is not radioactive In this study~     the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab~     (Herceptin™). By giving you this tracer after you have treatment with trastuzumab~     (Herceptin™), we will be able to use PET scans to show us which parts of your body and tumor~     sites the Herceptin goes to. This will help us to understand better how Herceptin works in~     the body to fight cancer.~   "
225576|NCT00605384|"~     The purpose of this clinical research study is to find out whether a combination of entecavir~     (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added~     to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant~     against lamivudine. The safety of this treatment will also be studied.~   "
225577|NCT00605371|"~     This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine~     XR in healthy male and female volunteers~   "
225578|NCT00605358|"~     The purpose of this study is to test the effectiveness of Open Door (previously known as the~     Treatment Initiation Program [TIP]), a brief psychosocial intervention to address the~     psychological barriers to care and improve the use of mental health services by depressed~     community elderly. The intervention is designed to help the older adult identify the~     barriers, problem-solve to find solutions and mobilize the motivation to seek help. Open Door~     was developed to work collaboratively with an older adult who is depressed to improve access~     and adherence to mental health treatment.~   "
225618|NCT00604825|"~     The purpose of this study is to determine whether GSK232802 is safe and effective in reducing~     the frequency and severity of hot flashes associated with menopause.~   "
225623|NCT00604760|"~     To establish the proof of concept that MEM 3454, used as add-on pharmacotherapy, is a safe~     and effective treatment in patients with cognitive impairment associated with schizophrenia~     (CIAS).~   "
225586|NCT00605254|"~     This study will test the use of a radioactive substance called [11C]dLop for measuring~     P-glycoprotein (P-gp) using positron emission tomography (PET) imaging. The P-gp protein acts~     as a pump in cells, affecting a variety of functions, such as limiting drug absorption and~     elimination and decreasing drug penetration into certain tissues, such as the brain. It is a~     major obstacle to successful chemotherapy because it can pump cancer drugs out of the cells,~     interfering with treatment. Decreased P-gp function may contribute to disorders such as~     Parkinson s disease and Alzheimer s disease, whereas higher levels of the protein have been~     found in patients with epilepsy and in several forms of drug-resistant cancer tumors. This~     study will determine uptake and clearance of [11C]dLop and the radiation exposure to organs~     of the body to assess its possible use in further studies of P-gp function.~      Healthy normal volunteers between 18 and 51 years of age may be eligible for this study.~     Candidates are screened with a medical history, physical examination and blood and urine~     tests.~      Participants undergo the following procedures:~        -  Electrocardiogram (ECG): A test of the electrical function of the heart.~        -  Brain PET scans: PET imaging uses small amounts of a radioactive chemical called a~          tracer that labels active areas of the brain so the activity can be seen with a special~          camera. The tracer used in this study is [18F]FMPEP-d(2). Before starting the scan, a~          catheter (plastic tube) is placed in a vein in the arm to inject the tracer and another~          catheter is placed in an artery in the wrist to obtain blood samples during the scan.~          For the procedure, the subject lies on the scanner bed. A special mask is fitted to the~          head and attached to the bed to help keep the person s head still during the scan so the~          images will be clear. A brief scan is done just before the tracer is injected to provide~          measures of the brain that are helpful in calculating information from subsequent scans.~          After the tracer is injected, pictures are taken for about 2.5 hours, while the subject~          lies still on the scanner bed. Blood and urine tests are done after 24 hours after the~          scan.~        -  Magnetic resonance imaging (MRI): An MRI scan is done within 1 year (before or after) of~          the PET scan. This procedure uses a magnetic field and radio waves to produce images of~          the brain. The subject lies on a table that is moved into the scanner (a tube-like~          device), wearing earplugs to muffle the noise of the machine during the scanning~          process. The test takes about 1 hour.~   "
225587|NCT00605241|"~     GSK598809 is being developed as an innovative treatment for substance dependence and~     potentially other compulsive behavioral disorders. This study will asses the effects of a~     single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male~     volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or~     GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of~     at least seven days between each session.~   "
225588|NCT00605228|"~     Primary:~      - To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to~     colonoscopy.~      Secondary:~        -  To assess the safety of Moviprep® versus Colopeg®.~        -  To assess acceptability of Moviprep® versus Colopeg®.~   "
225589|NCT00605215|"~     The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 mg~     with the effect of placebo capsules (capsules that contain no active medication) as well as~     with the effect of an existing MS injectable drug: Interferon β-1a (Avonex®).~   "
225590|NCT00605202|"~     This clinical trial is designed to study the effect of the combination of licorice and~     hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy~     volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily~     hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day~     for 14 days given in the other arm. The study is a randomized, open-label cross-over trial.~     There is at least a 3-week wash-out between the arms. The hypothesis is that the combination~     of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the~     change in the plasma level of potassium between the arms.~   "
225591|NCT00605189|"~     A randomized, controlled pilot study examining how cellular energetics related to various~     wound treatment therapies in patients with diabetic foot ulcers.~   "
225592|NCT00605176|"~     The purpose of this study is to determine whether imiquimod creams are effective in treating~     Actinic Keratoses when applied to the face or balding scalp.~      Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the~     sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient~     contained in the study cream for this study is the same as that of the approved product~     Aldara, which has been shown to be safe and effective for the treatment of AKs.~   "
225593|NCT00605163|"~     The purpose of this study is to longitudinally follow consenting clinical trial participants~     who participated in PRECEPT (A Randomized, Double Blind, Placebo Controlled, Dose Finding~     Study to Assess the Efficacy and Safety of CEP 1347 in Patients With Early Parkinson's~     Disease). The study will assess the clinical and imaging outcomes relevant to the natural~     history of Parkinson's disease (PD), as well as determine early biomarkers of the disease.~   "
225594|NCT00605150|"~     MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian~     device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to~     surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can~     have placement of appropriately positioned hepatic arterial catheters. Outcomes of this~     treatment protocol will be monitored and reported to the Carolinas HealthCare System~     Institutional Review Board.~   "
225595|NCT00605137|"~     This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin~     detemir and insulin NPH in children with type 1 diabetes.~   "
225596|NCT00605124|"~     Total knee arthroplasty (TKA) is performed more than 7.000 times a year in Finland most often~     for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever~     reach that of age-matched, uninjured subjects. Quadriceps weakness has been implicated in the~     development and progression of knee OA and is a significant problem after TKA. Advance to~     return to normal daily activities is not sufficient to restore knee function or quadriceps~     strength after TKA.~      The aim of this study is to assess the effectiveness of progressive exercise program~     restoring knee strength, mobility and improving the functional outcome after primary TKA.~   "
225597|NCT00605111|"~     This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and~     safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes~     failing OAD therapy.~   "
225619|NCT00604812|"~     A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed~     drug in pediatric subjects with migraines.~      After completion of a portion of the study (Panels A and B), a regulatory agency issued an~     amended request that the 12-17 year old age group studied should include a similar number of~     male and female subjects. Therefore, the study was amended to add an additional panel of~     subjects (Panel C) to ensure gender balance specifically in this age group.~   "
225743|NCT00603200|"~     The purposeof this study is to determine the effect of a large volume paracentesis (procedure~     in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i~     patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the~     abdomen).~   "
225598|NCT00605098|"~     This is a multicenter, open, prospective and randomized study aimed at evaluating the~     pharmacokinetics of the tablet formulation of lopinavir/r administered in combination with~     two nucleoside analogs to HIV-infected pregnant women at two different dosages:~        -  Group 1 (standard dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours, plus two~          nucleoside analogs.~        -  Group 2 (increased dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours until the~          end of the second trimester of gestation (24 weeks) and 3 tablets every 12 hours in the~          third trimester (from 25 weeks on), plus two nucleoside analogs.~      Treatment will be initiated at any time between 14 and 30 weeks of gestation and will be~     maintained for at least 6 weeks after delivery.~      The objectives are:~        -  To compare the pharmacokinetic parameters of the standard and increased dosage of the~          tablet formulation of lopinavir/r during pregnancy.~        -  To determine whether the standard and/or increased dosage of the tablet formulation of~          lopinavir/r during pregnancy confers the same exposure to the drug as that observed in~          the same women after the end of pregnancy and in historic controls.~        -  To evaluate the transplacental passage of lopinavir/r based on the ratio between the~          serum concentration in maternal blood at the time of delivery and in cord blood of the~          two drug dosages (standard and increased) administered during pregnancy.~        -  To evaluate the tolerability of the two lopinavir/r dosages (standard and increased)~          during pregnancy.~        -  To describe the vertical transmission rate of HIV to the children of the pregnant women~          included in the study.~   "
225599|NCT00605085|"~     The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine~     IC51 with an inactive control in healthy subjects aged > or = 18 years~   "
225600|NCT00605072|"~     The purpose of this study is to examine the effects of blood pressure medications on~     cognition and blood flow in hypertensive elderly patients with cognitive impairment. The~     hypothesis is that treatment with an angiotensin receptor blocker (ARB) or an~     angiotensin-converting enzyme inhibitor (ACEI) will be associated with a slower rate of~     further cognitive decline, improved cerebral blood flow and its regulation, and preserved~     physical function as compared to treatment with a diuretic (HCTZ), independent of blood~     pressure level.~   "
225601|NCT00605059|"~     The main objectives of this proposal are as follows:~      To assess the dynamic uptake and washout of 123-I AV94, a potential imaging biomarker for~     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in~     similarly aged healthy controls and Alzheimer's (AD) subjects~      To perform blood metabolite characterization of 123-I AV94 in healthy and AD subjects to~     determine the metabolic fate and nature of metabolites in assessment of 123-I AV94 as a~     single photon computed tomography (SPECT) brain imaging agent~      Evaluate the test/retest reproducibility of 123-I AV94 and SPECT in AD subjects and healthy~     controls~   "
225602|NCT00605046|"~     Purpose:~      The main objectives of this proposal are as follows:~      To assess the dynamic uptake and washout of 123-I AV151, a potential imaging biomarker for~     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in~     similarly aged healthy controls and Alzheimer's (AD) subjects~      To perform blood metabolite characterization of 123-I AV151 in healthy and AD subjects to~     determine the metabolic fate and nature of metabolites in assessment of 123-I AV151 as a~     single photon computed tomography (SPECT) brain imaging agent~      Evaluate the test/retest reproducibility of 123-I AV151 and SPECT in AD subjects and healthy~     controls~   "
225603|NCT00605033|"~     Post-marketing commitment to the European Medicines Agency to conduct a prospective,~     controlled study of the transfer from Subutex to Suboxone.~   "
225604|NCT00605020|"~     This trial is conducted in Europe.~      The aim of this trial is to investigate the efficacy and safety of an intensified treatment~     regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more~     convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in~     subjects with type 2 diabetes.~   "
225605|NCT00605007|"~     Hyperglycemia is a common complication of corticosteroid (cortisone) therapy. It is estimated~     that more than a third of patients with chronic pulmonary disease (COPD) exacerbation (16).~     Despite its frequency, the impact of corticosteroid-induced diabetes on clinical outcome and~     mortality is not known. A computerized search of biomedical journal literature from MEDLINE,~     PubMed, and Ovid from 1966 to 2006 provided very little information on the prevalence and~     outcome of corticosteroid-induced diabetes in patients with COPD. Therefore, the present~     study aims to evaluate the impact of corticosteroid-induced diabetes on clinical outcome in~     patients with COPD exacerbation. We will perform a retrospective chart review of all patients~     admitted to the hospital with COPD exacerbation from 1/01/05 to 06/30/06 at Grady Memorial~     Hospital. Medical records of all patients with COPD exacerbation treated with corticosteroids~     will be analyzed. Data on demographics, laboratory values, mortality rate, rate of~     hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.~   "
225606|NCT00604994|"~     This project will conduct a prospective, longitudinal, observational cohort study to assess~     the onset and incidence of lymphoedema, as well as investigate factors associated with its~     development among women newly diagnosed with gynaecological cancers in 2008 to 2011.~   "
225620|NCT00604799|"~     A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel~     that carries blood away from your heart to organs in the rest of your body. Your aneurysm is~     caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow~     larger and may ultimately rupture (break open) or extend in size to seriously affect other~     major arteries in the area. In this Research Study a device will be placed inside your aorta~     to block the weakened part of the artery wall from the circulatory system. Information will~     be collected on the performance for the device for 5 years.~   "
225621|NCT00604786|"~     This research is being done to study the effects of the drug omalizumab (Xolair) in people~     with cat allergies. The investigators will use omalizumab to study changes in the cells in~     the nose, skin and blood that cause allergies. The investigators predict that cells in the~     blood will be effected before cells in the nose or skin.~   "
225744|NCT00603187|"~     We propose oral dosing of gastrointestinal permeation enhancement technology [GIPET] enhanced~     oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose)~     pharmacokinetics of oral acyline in four normal, healthy young men.~   "
225607|NCT00604981|"~     Despite the dramatic increase in obesity and Type II Diabetes in adolescents, documented~     effective treatments for obesity and the consequential prevention of Type II Diabetes are~     scarce. Modification of food and activity choices is the foundation of obesity treatment;~     however, adolescents may find it difficult to follow recommended diet and exercise programs.~     This study uses a home-based treatment, Multisystemic Therapy (MST), to target change within~     the individual, family and environmental contexts. Participants are 49 obese (BMI>95th~     percentile) African American adolescents (ages 12-17). 24 were randomized to receive the MST~     intervention and 25 were placed in Shapedown, a family group program. Families were recruited~     from the only university-affiliated medical center in Detroit, Michigan. Michigan's youth~     have higher rates of obesity, overweight, hypertension, and elevated cholesterol compared to~     the national average, and Detroit has the highest percentage of African Americans of any~     major city in the US. Families complete measurements at the start of the treatment, at the~     end of the treatment and one year after enrollment. We expect to find that youth in the MST~     group will show more weight loss and greater improvements in diet (e.g., caloric intake and~     exercise behaviors than will youth in Shapedown. These changes in food choices, activity~     levels, and weight are expected to remain after the end of treatment. This intervention is~     intended to provide immediate assistance to a vulnerable population disproportionately~     affected by obesity and its long-term health complications.~   "
225608|NCT00604968|"~     The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal~     doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for~     metastatic or locally advanced breast cancer, not amenable to surgery.~   "
225609|NCT00604955|"~     This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection~     when given to an expanded population in the outpatient setting in experienced VL centers and~     subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin~     IM Injection to progressively more resource-constrained clinics in Bihar, India.~   "
225610|NCT00604942|"~     Recent work at St. Thomas' has validated an innovative new design of a multichannel~     intraluminal impedance (MII) catheter that is sensitive to variation in oesophageal volume in~     healthy volunteers and patients. This project will establish the clinical value of volume~     sensitive MII (vMII) compared to conventional MII acquired simultaneously by the same~     catheter (ROC analysis). Studies will assess:~        1. The accuracy of volume measurements and correlation between symptoms and the volume of~          bolus retention in patients with dysphagia.~        2. The accuracy of volume measurements and correlation between symptoms and reflux volume~          in patients with reflux disease.~      Follow up studies after appropriate treatment will assess whether symptomatic improvement is~     associated with a reduction in oesophageal volume retention/reflux.~      The vMII technique will be applied with high resolution manometry (HRM). These investigations~     are complementary in that vMII assesses the success or failure of bolus transport (or~     occurrence of reflux) and HRM can assess:~        1. the oesophageal dysfunction that results in bolus escape~        2. the abnormal events at the gastro−oesophageal junction (reflux barrier) that allow~          reflux to occur.~      with a reduction in oesophageal volume retention / reflux.~   "
225611|NCT00604929|"~     The present proposal is designed to examine the effect of carbohydrate and protein~     co-ingestion on muscle protein synthesis during endurance type exercise activities. We~     hypothesize that muscle protein synthesis is higher when protein is co-ingested during~     exercise.~   "
225612|NCT00604916|"~     The Nosocomial Pneumonia remains to be a major complication for patients who were incubated~     with ventilation. Most cases are attributed to increased bacteria flora in oropharyngeal~     secretion and aspiration of those organisms. Research indicates that the Gram-Negative~     Bacteria grows in upper air way and trachea rapidly during the initial 2-4 hospital days and~     the dental plague also increased dramatically at the first 5 days. About 50% cases with~     prolonged intubation experienced temporal swallowing disorders and majority of them recovered~     7 days post weaning. Some evidence exist suggesting that oral care could reduce bacterial~     flora, prevent aspiration, and subsequently decrease the incidence of ventilation-associated~     pneumonia for this group of high risk patients.~      This study aims to evaluate the effectiveness of a standardized oral care protocol in~     improving oral hygiene and reducing the incidence of pneumonia on a sample of surgical~     patients at intensive care unit.~   "
225613|NCT00604903|"~     The purpose of this study is to evaluate and document appropriate clinical safety and~     performance of the Remon CHF Implantable Pressure Sensor including the corresponding delivery~     system, the Remon CHF Home Unit, the Remon CHF Clinic System devices and associated~     application software. It is a small clinical trial to determine the feasibility of the~     device. The primary outcome measure relates to feasibility and not to health outcomes.~   "
225614|NCT00604890|"~     The purpose of this study is to determine the safety and tolerability of pharmaceutical~     compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to~     obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by~     API 31510 topical cream. The study population will include one hundred and sixty (160)~     otherwise healthy male or female adults with one or more histologically confirmed superficial~     basal cell carcinoma lesions. One target lesion with an area of less than one inch will be~     designated for study treatment.~   "
225615|NCT00604877|"~     This study examines the hypothesis that 6 months of treadmill aerobic exercise training~     improves fibrinolysis (clot defense mechanism) and vasomotor function in chronic hemiparetic~     (muscular weakness or partial paralysis restricted to one side of the body) stroke patients~     compared to a control intervention, and that these changes are associated with reduced plasma~     insulin levels and improved insulin sensitivity / glucose metabolism in this population.~   "
225616|NCT00604864|"~     Deep endometriosis associated pain is believed to be caused by inflammation. Anti TNFa has~     been proved to be an effective treatment for other inflammation related conditions as Crohn's~     disease Endometriosis is associated with an inflammatory response in the pelvis, which is~     mediated by a number of cytokines including TNF-α. It has therefore been suggested that~     infliximab, an anti-TNF-α monoclonal antibody, might relieve pain in affected women.~   "
225617|NCT00604838|"~     The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner~     (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between~     wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is~     caused by urinary incontinence.~   "
225624|NCT00604747|"~     Background: The literature indicates that, in relation to motor learning, healthy subjects~     benefit more from random practice than from constant practice. However, this effect is not~     well known in post-stroke patients. Objective: The goal of this study was to investigate the~     effects of practice structure on motor learning in post-stroke patients. Methods:~     Participants included an experimental group (EG) of post-stroke patients: 17 males and~     females; and a control group (CG) of healthy individuals: 17 males and females. At the~     acquisition phase, all participants performed 30 trials of a coincident timing task. Nine~     individuals from each group practiced constantly (C) at a stimulus propagation speed of 3~     mph, and eight from each group practiced randomly (R) at speeds of 2, 3, and 5 mph.~     Subsequent phases included: 1) transfer, 2) retention after 15 minutes, and 3) retention~     after 3 days. Each of these phases included 20 trials: 10 at a speed of 1 mph, and 10 at a~     speed of 4 mph. Intra- and inter-group comparisons were made employing an alpha level of 0.05~     (5%).~   "
225625|NCT00604734|"~     This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip~     Resurfacing System.~   "
225626|NCT00604721|"~     This phase II trial is studying selumetinib to see how well it works in treating patients~     with locally advanced or metastatic liver cancer. Selumetinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for their growth.~   "
225627|NCT00604708|"~     The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51~     compared to JE-VAX in healthy subjects aged > or = 18 years~   "
225628|NCT00604695|"~     The primary objective of this study is to gather preliminary data regarding the angiographic~     efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during~     balloon angioplasty for heart attacks.~      We hypothesize that low-dose IC tenecteplase will enhance the breakdown of blood clots at the~     site of the culprit lesion leading to reduced damage to the heart muscle.~   "
225629|NCT00604682|"~     Open label study for patients with severe plaque type psoriasis. This study is looking to~     evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the~     epidermal thickness in subjects with severe placque type psoriasis.~   "
225630|NCT00604669|"~     A growing body of evidence suggests hyperglycemia is associated with adverse outcomes in~     patients with and without diabetes. Observational studies document an association between~     hyperglycemia and poor clinical outcomes in cardiothoracic surgery, elective surgery,~     myocardial infarction, stroke. Randomized studies indicate glycemic control is associated~     with improved outcomes in diabetic patients with critically illness. Hyperglycemia is a~     recognized and common complication of patients receiving total parenteral nutrition (TPN).~     Few studies in the literature have looked into the impact of TPN-associated inhospital~     complications and mortality. Accordingly, this study aims to evaluate the impact of~     hyperglycemia on clinical outcome (infections, systemic sepsis, cardiac complications, acute~     renal failure, length of stay, and mortality) in patients receiving TPN. We will perform a~     retrospective chart review of all patients treated with TPN from 1/01/06 to 12/31/06 at Grady~     Memorial Hospital. We hypothesize that patients receiving TPN who develop hyperglycemia~     experience higher morbidity (infections, systemic sepsis, cardiac complications, acute renal~     failure, length of stay) and mortality compared to TPN patients with euglycemia. The results~     of this study will help us to formulate a prospective randomized clinical trial on the~     management of TPN-associated hyperglycemia in hospitalized patients.~      This study aims to evaluate the impact of hyperglycemia on clinical outcome (infections,~     systemic sepsis, cardiac complications, acute renal failure, length of stay, in hospital~     mortality) in patients receiving total parenteral nutrition. We will perform a retrospective~     chart review of all patients admitted to the hospital receiving TPN from 1/01/06 to 12/31/06~     at Grady Memorial Hospital. The results of this study will help us to formulate a prospective~     randomized clinical trial on the management of TPN-associated hyperglycemia in hospitalized~     patients.~   "
225631|NCT00604656|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety and~     efficacy of insulin aspart produced by current process compared to that of insulin aspart~     produced by NN2000 process in subjects with type 2 diabetes.~   "
225632|NCT00604643|"~     An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who~     have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for~     treatment with an AneuRx Aortic Cuff.~   "
225633|NCT00604630|"~     The purpose of this randomized, double-blind, placebo-controlled multicenter study is to~     determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral~     artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment~     on functional outcome up to a follow-up of 90 days.~   "
225634|NCT00604617|"~     Tuberculosis (TB) is a disease affecting the lungs that is caused by a germ spread by~     coughing. TB infection is currently diagnosed by a skin test that has limited accuracy. The~     purpose of this study is to look at the reliability of a new blood test for diagnosing TB~     infection in children. Study participants will include 300 HIV-infected (HIV infection is a~     viral infection that causes disease which destroys the body's ability to protect itself from~     infection and disease.) children and 500 HIV-uninfected children, ages 3 months to 5 years,~     residing in the Khayelitsha and Ravensmead/Uitsig Communities of the Western Cape Province,~     South Africa. Study procedures will include questionnaires, HIV and TB testing, which will be~     performed by blood and skin tests. Participants may be involved in study related procedures~     for up to 24 months.~   "
225635|NCT00604604|"~     The primary objective of this study is to evaluate the effect of peer (mother-to-mother)~     support on the prevention of postpartum depression among mothers identified as high-risk.~   "
225636|NCT00604591|"~     This study will test the effects of a medication called tolcapone on cognitive, behavioral,~     and language problems seen in patients with frontotemporal dementia (FTD). Tolcapone~     increases the amount of dopamine, a brain chemical that may be lowered in FTD. The study will~     see if tolcapone can improve thinking, behavior, and language in people with FTD and will~     look at the effects of the drug on brain activity.~      Patients with FTD who are between 40 and 85 years of age may be eligible for this study.~      Participants will be seen as outpatients at the Columbia University Medical Center~     approximately one a week for 4 weeks. They take tolcapone or a placebo (a look-alike pill~     with no active ingredient) during study week 1. During study week 3, those who took placebo~     during week 1 now take tolcapone for 1 week and those who took tolcapone now take placebo. In~     addition, patients undergo the following tests and procedures:~        -  Neurological tests to evaluate attention, problem-solving and memory. These tests are~          repeated several times during the course of the study.~        -  Test to look for a gene that affects the amount of dopamine in the brain, using blood~          samples collected in a previous study.~        -  Blood draws four times during the study.~        -  Functional MRI (fMRI) to learn about changes in brain regions that are involved in~          performing tasks. For fMRI, the patient lies on a table that can slide in and out of the~          scanner, a narrow metal cylinder surrounded by a magnetic field. The procedure takes~          about 60 minutes and is performed four times over the course of the . FMRI involves~          taking pictures of the brain during MRI while the subject performs a task so that~          changes in the brain that occur during these tasks can be studied.~   "
225637|NCT00604578|"~     This study will test whether pioglitazone hydrochloride (Actos (Registered Trademark)~     Registered Trademark) is effective for treating patients with asthma who do not respond to~     standard therapy. Experiments have shown that this drug, which is used to treat patients with~     diabetes, may be effective for treating asthma.~      People between 18 and 75 years of age who have had asthma for at least a1 year and whose~     symptoms are not well controlled with high doses of inhaled corticosteroids with or without~     long-acting bronchodilators may be eligible for this study. Candidates are screened with~     breathing tests, an allergy skin test, chest x-ray, electrocardiogram (ECG), echocardiogram~     (ultrasound test of the heart), blood tests, and DEXA scan (an x-ray to measure bone~     thickness) to make sure they are eligible for the study.~      Then, participants undergo tests and procedures in the following study phases:~      Phase 1~      Participants are given a device to measure and record their lung function and asthma symptoms~     at home each morning and night for 4 weeks before starting the study medication. Lung~     function is also measured at clinic visits before and after inhaling a bronchodilator~     medicine. Before starting the study medication, participants have a sputum induction (sputum~     collection test). For this test, the participants inhale a salt-water mist and are asked to~     collect sputum into a plastic cup.~      Phase II~      Participants are randomly selected to receive either pioglitazone hydrochloride or placebo (a~     look-alike pill with no active ingredient) once a day for 10 weeks. They return to the clinic~     after 2 weeks to repeat the tests done in Phase 1 and to monitor any reactions to the study~     drug or placebo. If there are no problems, the amount of medication is increased once, and~     then they return for follow-up evaluations every 2 weeks for 8 weeks. Pulmonary function~     tests, sputum collection and DEXA scan are repeated after 10 weeks on medication.~      Phase III~      Patients return for follow-up 1 month after stopping the medication or placebo to monitor~     their asthma.~   "
225638|NCT00604565|"~     In maintenance hemodialysis patients, regular administration of parenteral iron by addition~     of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional~     dialysate, is effective in preventing the development of iron deficiency, thereby maintaining~     hemoglobin level; is clinically safe and does not lead to oxidative stress or inflammation.~   "
225639|NCT00604552|"~     The aorta is a large blood vessel that carries blood away from the heart to the organs in the~     rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in~     the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break~     open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion~     that has been treated in recent year via endovascular repair.~      The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft~     Systems.~   "
225640|NCT00604539|"~     The purpose of this study is to determine the effect of a chondroitin sulphate conventional~     treatment on the degree of severity of synovitis, as measured by magnetic resonance in~     patients with knee OA with clinical synovitis.~   "
225641|NCT00604526|"~     High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary~     radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and~     then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR~     brachytherapy gives precise radiation to the prostate with less radiation given to the normal~     tissues near the prostate. For patients who have been treated with external beam radiation to~     the prostate before, HDR brachytherapy can give radiation again to the prostate without~     exposing the normal tissues around the prostate to significantly more radiation. This may be~     safer than giving external beam radiation again. The purpose of this study is to test the~     safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back~     after external beam radiation. We want to find out what effects, good and/or bad, the~     treatment has on you and your recurrent prostate cancer.~   "
225642|NCT00604513|"~     The goal of Ready, Set, ACTION! (RSA) is to test the feasibility of implementing a~     theater-based after-school program to promote healthy eating, physical activity, and positive~     body image with children in grades four through six.~   "
225643|NCT00604500|"~     This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F)~     metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI~     50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of~     age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease~     (COPD) of at least 12 months. The primary purpose of the study was to evaluate the~     performance of the MF/F MDI integrated dose counter under normal patient handling conditions.~   "
225644|NCT00604487|"~     Artificial ripening of the cervix and induction of labor remain as one of the therapeutic~     challenges in Obstetrics. The method widely used, the intravenous administration of Oxytocin,~     is associated with prolonged induction periods, a significant failure rate, and considerable~     patient discomfort. Therefore, over the years, a variety of locally applied pharmacological~     and physical ripening agents were evaluated. Currently, the commonly utilised local ripening~     agent is a Prostaglandin (PG) preparation. Although PG is being applied vaginally or~     extra-amniotically, systemic absorption of this agent is common, sometimes resulting in~     uterine hypertonicity, nausea and vomiting. In addition, both induction methods are~     associated with the initiation of uterine contractions, sometimes lasting for prolonged~     periods. Therefore a preferred induction method may be a mechanical one which will lead to~     cervical ripening without causing uterine contractions. Furthermore, there are additional~     potential advantages of mechanical methods compared to pharmacologic methods such as, ease of~     storage, low cost and less side effects. A folly catheter, inserted through the cervix,~     combined with continuous extra-amniotic NS instillation is being used for this purpose for~     many years. However this method although effective may cause uncomfortable traction of the~     balloon to the women's leg. Furthermore, dripping of saline through the cervix and vagina,~     occasionally occurs, may be annoying, and may be confused with rupture of membrane. We have~     recently introduced a newly developed balloon device (Atad Ripener Device), which was~     designed with one balloon located at the distal end of the device (the uterine balloon, U),~     while the other balloon is located 1.5 cm proximal to the first one (the cervicovaginal~     balloon, CV). Both balloons are expandable with Saline. The balloon inflated in the vagina~     provides the traction action and seals the cervix from saline leakage. Another balloon the~     AID (Atad double balloon Instillation Device) is identical to the ARD but has an additional~     long tip for instillation of normal to the extra-amniotic space. To the best of our~     knowledge, no comparison was performed between the use of the double balloon ripener device~     and folly catheter for induction of labor. Furthermore, there are no published data regarding~     the use of the double balloon instillation device (AID) combined with continuous~     extra-amniotic NS instillation. This study is designed to compare the efficacy, safety and~     side effects of mechanical methods of cervical ripening and labor induction by the double~     balloon device (ARD), the double balloon instillation device (AID) combined with continuous~     extra-amniotic instillation of normal saline and the folly catheter combined with continuous~     extra-amniotic normal saline instillation. The study aims at the accrual of 300 women (100~     randomised in each arm).~   "
225645|NCT00604474|"~     The primary objective to this study is to describe the auditory development and performance~     of young deaf children who receive bilateral implants during the first two years following~     device activation.~   "
225646|NCT00604461|"~     The purpose of this research study was to evaluate how effective the combination of~     Carboplatin, Bevacizumab (Avastin™) and, Pemetrexed (Alimta™) is in the treatment of patients~     with Malignant Pleural Mesothelioma (MPM). A combination of cisplatin and pemetrexed is~     considered standard for this disease and typically off protocol patients would receive~     cisplatin or carboplatin and pemetrexed as standard of care.~      The planned length of the study (first patient screened to last patient enrolled) was 24~     months. The planned length of the entire study (enrollment period + the treatment period + a~     follow-up period of at least 12 months) was 36 months.~   "
225757|NCT00603005|"~     The purpose of this study is to study the effect on intraocular pressure in glaucoma patients~     using the TravAlert dosing aid with or without the Eyot drop guider and with or without~     additional patient education.~   "
225647|NCT00604448|"~     In 2004, almost 60% of adult Canadians were overweight or obese. This is a serious health~     concern due to the burden of common health risks associated with being overweight and obese,~     including increased blood sugar, blood lipids and blood pressure. Together these risks are~     known as metabolic syndrome. Obesity, the most common nutrition problem in Canada, can in~     many cases be treated through changes in our diet (what we eat and/or how much we eat).~     Pulses (beans, chickpeas, lentils and peas) when eaten on a regular basis may result in~     decreased health risks associated with being overweight and obese. The purpose of this study~     is to find out whether eating pulses (5 cups per week) results in improvements in metabolic~     syndrome risk factors. We also want to determine whether the consumption of pulses alters the~     levels of satiety hormones (hormones that make us feel hungry or full) in the blood. This~     study will have 50 participants.~   "
225648|NCT00604435|"~     This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and~     epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer~     patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy~     to chemotherapy could further enhance the cytotoxic activity in breast cancer.~   "
225649|NCT00604422|"~     To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify~     Ulcerative colitis~   "
225650|NCT00604409|"~     This trial is testing the safety of combining the oral chemotherapy drug capecitabine with~     radio-labeled microspheres injected directly into the liver.~   "
225651|NCT00604396|"~     This trial is conducted in Europe.~      The aim of this trial is to investigate the safety and efficacy of insulin detemir combined~     with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic~     drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose~     control.~   "
225652|NCT00604383|"~     This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three~     years will reduce vision loss associated with diabetic retinopathy.~   "
225653|NCT00604370|"~     An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.~   "
225654|NCT00604357|"~     Background:~      Patients undergoing liver transplantation with preexisting renal dysfunction are prone to~     further renal impairment with the early postoperative use of Calcineurin-inhibitors. However,~     there is only little scientific evidence for the safety and efficacy of de novo CNI free~     regimens in patients with impaired renal function undergoing liver transplantation. The~     objective of the study is to evaluate a de novo calcineurin-inhibitor-free immunosuppressive~     regimen based on induction therapy with anti-CD25 monoclonal anti- body, mycophenolate~     mofetil (MMF/MPA), and mTOR-inhibition to determine its safety and to investigate the~     preliminary efficacy in patients with impaired renal function at the time of liver~     transplantation. Methods/Design: Patients older than 18 years with renal impairment at the~     time of liver transplantation due to hepatorenal syndrome, eGFR < 50 ml/min and/or serum~     creatinine levels > 1.5 mg/dL will be included. Patients will receive a combination therapy~     with antiCD25-monoclonal antibodies, MMF, steroids and delayed sirolimus (day 10) and will be~     evaluated with regards to the incidence of steroid resistant acute rejection within the first~     30 days after liver transplantation as the primary endpoint. The study is designed as~     prospective two-step trial requiring a maximum of 29 patients. In the first step 9 patients~     will be included. If 8 or more patients show no signs of biopsy proven steroid resistant~     rejection, additional 20 patients will be included. If in the second step a total of 27 or~     more patients reach the primary end-point the regimen is regarded to be safe and efficient.~     The follow up period will be one year after transplantation. The aim is to obtain safety and~     efficacy data for this new and innovative therapy regimen that might be the basis for a large~     prospective randomized multicenter trial in the future.~   "
225655|NCT00604344|"~     This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of~     insulin detemir on blood glucose control in subjects with insulin requiring diabetes.~   "
225656|NCT00604331|"~     Pyruvate is an intermediate of energy metabolism and was shown to possess pronounced positive~     inotropic effects in vitro and in vivo without altering myocardial oxygen consumption.~     Moreover, it was shown that the effects of beta-adrenergic stimulation were potentiated.~     Thus, it might be possible to save catecholamines in patients with severe heart failure or~     cardiogenic shock. This study was designed to test the hemodynamic effects of pyruvate~     administered into a coronary artery in addition to intra-aortic balloon pump counterpulsation~     in patients with severe heart failure or in patients with acute myocardial infarction and~     cardiogenic shock after having performed percutaneous coronary intervention. A pronounced~     improvement in hemodynamics is expected to occur.~   "
225657|NCT00604318|"~     To evaluate quality of life in patients after 10 days pause of thyroid medication~     (Liothyronine) compared to treatment with recombinant TSH (Thyrogen) before radioiodine~     uptake and treatment in a double-blinded, randomised cross-over design.~   "
225658|NCT00604305|"~     a comparison of two intraocular lenses in regard of accommodative power.~   "
225659|NCT00604292|"~     To evaluate the effect of a modified preparation and procedure on colon cleansing level~   "
225660|NCT00604279|"~     The purpose of this study is to compare the efficacy of paliperidone palmitate and~     risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric~     disorder with symptoms of emotional instability, detachment from reality, often with~     delusions and hallucinations, and withdrawal into the self) along with safety and~     tolerability.~   "
225661|NCT00604266|"~     To evaluate the feasibility and performance of coregistered 18F-FDG-PET/MRI in the staging of~     potentially respectable hilar cholangiocarcinoma.~   "
225662|NCT00604253|"~     This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of~     insulin detemir on blood glucose control in type 2 diabetes when added to current OHA~     treatment.~   "
225663|NCT00604240|"~     The first few weeks after leaving the Neonatal Intensive Care Unit (NICU) can be a difficult~     transition time for caregivers of a previously hospitalized infant. To help ease this~     stressful period, doctors and nurses give caregivers a large amount of information prior to~     their infant leaving the NCIU. How much caregivers remember about medications, follow-up~     appointments, and general well-child care has not been studied. Caregivers who choose to~     participate will receive a phone call 2-7 days after discharge where they will be asked~     questions pertaining to the information that was discussed with them at the time of~     discharge. The purpose of the study is to determine how much information caregivers retain~     after leaving the NICU.~   "
225677|NCT00604058|"~     The present study intends to investigate the use of fractional doses of sanofi pasteur's~     IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the~     non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full~     doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio~     types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14~     weeks of age.~   "
225664|NCT00604227|"~     Based on the findings of decreased vital capacity, decreased FEV1 and increased closing~     volume after ascent to high altitude, some investigators suggest the presence of a~     subclinical high altitude pulmonary edema (HAPE). Since these parameters are only indirect~     measures of pulmonary interstitial fluid accumulation, the aim of this study is to examine~     the effects of broncho-constriction on the increase of closing volume by extensive lung~     function testing in healthy mountaineers at low altitude and on the Margherita Hut (4559 m).~     As has been done in earlier studies, conventional thorax radiographs are used for~     verification of HAPE. In this study, the determination of the thoracic fluid quantity will be~     completed by measurements of thoracic impedance. In addition markers of pulmonary endothelial~     function will be assessed to get further insight into the regulation of pulmonary vascular~     tone at altitude and in particular into the pathophysiology of HAPE.~   "
225665|NCT00604214|"~     The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated)~     treatment provides significant mortality reduction improvement in patients with septic shock~     compared with placebo treatment in patients receiving the current standard of care for septic~     shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in~     reducing 28-day mortality in patients with septic shock and concomitant severe protein C~     deficiency.~   "
225666|NCT00604201|"~     This study will evaluate the safety and effectiveness of treating patients with severe~     aplastic anemia (SAA) or myelopdysplastic syndrome (MDS) with both peripheral blood stem~     cells from a family member and umbilical cord blood stem cells from an unrelated donor.~      Patients with SAA or MDS for whom other treatments have failed or are not available may be~     eligible for this study. Candidates may not have a tissue-matched sibling or matched~     unrelated donor and must have a family member who is a partial tissue type match.~      Participants undergo the following tests and procedures:~        -  Insertion of a central intravenous (IV) line (plastic tube) into a large vein. The tube~          is used for giving the donated stem cells and antibiotics and other medicines, for~          transfusions of red blood cells and platelets, and for collecting blood samples.~        -  Preparatory chemotherapy (fludarabine, cyclophosphamide and anti-thymocyte globulin) and~          total body irradiation to suppress immunity and prevent rejection of the donated cells.~        -  Infusion of the donated stem cells and umbilical cord cells.~        -  Immune suppression with the drugs tacrolimus, mycophenolate mofetil and prednisone to~          prevent rejection of the donated cells and to prevent graft-versus-host disease (GVHD),~          a complication of stem cell transplants in which the donor s immune cells destroy the~          patient s healthy tissues.~      The average hospital stay after stem cell transplantation is 3 to 4 weeks. Patients return~     for frequent follow-up visits for the first 2 to 4 months after transplantation. Once the~     patient returns home, his or her referring physician is asked to send results of any~     laboratory testing to the NIH researchers at least every 3 months for the first 3 years and~     annually thereafter. Patient follow-up visits are scheduled at NIH at 1, 2, 3, 4 and 5 years~     after transplantation to monitor for signs of disease or post-transplantation complications,~     such as infection or GVHD. After 5 years, participants are offered the opportunity to enroll~     in NHLBI s long-term evaluation and follow-up care protocol.~   "
225667|NCT00604188|"~     The purpose of this study is to assess the acceptability and safety of Suboxone in heroin~     users as a replacement therapy for opioid dependency by comparing the clinical response of~     participants who are inducted directly onto Suboxone with that of participants who are~     inducted first to Subutex and then transferred to Suboxone.~   "
225668|NCT00604175|"~     Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV~     infection can cause genital warts and certain cervical problems, including cervical cancer.~     HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of~     this study was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and~     effective in producing antibodies to HPV in HIV-infected women.~   "
225669|NCT00604162|"~     To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant~     colonic pathologies when compared to colonoscopy in the target population.~   "
225670|NCT00604149|"~     Sudden death is a major problem in industrially developed countries. Despite a decline in~     ischemic heart disease mortality and the progress has been made in resuscitation, treatment~     of sudden death victims is frequently unsuccessful. the ideal solution would be to prevent~     the disease process that causes the initial episode of cardiac arrest. Parental sudden death~     is an independent risk factor for sudden death. So, detect a gene predisposing to sudden~     death may help provide better identification of subjects at high risk of cardiac arrest. This~     research is a genetic study of sudden cardiac death, recruited 2000 subjects in~     out-of-hospital cardiac arrest.~   "
225671|NCT00604136|"~     Prior preclinical and clinical studies have shown that tumors from patients with advanced~     melanoma contain tumor-infiltrating lymphocytes (TIL) with anti-tumor reactivity. These TIL~     can be expanded in the laboratory to large numbers, and reinfused to the patient. Using a~     chemotherapy regimen that selectively kills lymphocytes, a single institution Phase II study~     of 35 patients showed a 51% objective response rate to TIL and interleukin-2 injection. In~     the present trial we would like to investigate whether we can achieve similar results in a~     Hadassah Phase II study, and to determine the feasibility of applying this approach to~     patients with advanced melanoma who currently have few treatment options.~   "
225672|NCT00604123|"~     The purpose of this study is to evaluate the clinical effectiveness, safety and~     pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis.~   "
225673|NCT00604110|"~     Patients with reduced left ventricular function are at an increased perioperative risk and~     often need prolonged postoperative treatment on intensive care units. A significant portion~     of these patients require postoperative pacing. Right ventricular pacing has been shown to be~     hemodynamically deleterious The aim of this study is to determine which biventricular pacing~     after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is~     hemodynamically favourable.~   "
225674|NCT00604097|"~     The purpose of the study is to test the efficacy of a brief family therapy (Attachment-Based~     Family Therapy) for youth presenting in primary care with suicidal ideation and depressed~     mood.~   "
225675|NCT00604084|"~     The purpose of this project is to develop a community scabies eradication and education~     program for the highly endemic areas surrounding the Veron community on the eastern tip of~     the Dominican Republic. It proposes the use of oral Ivermectin as a replacement for topical~     Lindane--a readily available medical formulation, pesticide, and environmental toxin that is~     reported to be banned in the Dominican Republic as well as over 80 other countries throughout~     the world.~   "
225676|NCT00604071|"~     estimate the sensitivity of the HMP test in identifying visual field functional defects in~     subjects with CNV secondary to AMD~   "
225678|NCT00604045|"~     The purpose of this study is to determine whether a computerized intervention designed to~     change the nature of attention biases will be effective in reducing the symptoms of post~     traumatic stress disorder (PTSD) in American combat veterans returning from the wars in~     Afghanistan and Iraq.~   "
225680|NCT00604019|"~     We are performing a prospective, randomized, controlled trial of dopamine versus~     norepinephrine for septic shock. The trial will enroll patients with suspected or documented~     site of infection and having 2 out of the three SIRS criteria. Patients will also be~     receiving standard of care, early-goal directed therapy including but not limited to fluid~     resuscitation, appropriate and early antibiotics, source control and evaluation for~     drotrecogin alpha where deemed appropriate, while being supported for septic shock.~   "
225681|NCT00604006|"~     Individuals who were a part of the investigators Screen-HF study (NCT00400257) whose BNP~     level are in the top quintile will be offered participation in this study. Participants will~     be randomised to receive either spironolactone or placebo for three years. Participants will~     then be monitored for indications of heart failure. It is anticipated that the medication~     will reduce the development of heart failure in this group.~   "
225682|NCT00603993|"~     The purpose of this study is to evaluate the long-term safety of subcutaneous (SC)~     self-injections (by the subject or subject's family member) of adalimumab in adult Japanese~     subjects with Rheumatoid Arthritis in an open-label study.~   "
225683|NCT00603980|"~     Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and~     Staccato Placebo.~   "
225684|NCT00603967|"~     The primary objective of this 2-year pilot project is to test the hypothesis that skeletal~     response to aromatase inhibitors is determined by polymorphisms of the CYP19 gene.~   "
225685|NCT00603954|"~     The present project aims at comparing two nonmyeloablative regimens currently used in 2 major~     HCT centers in the US for patients with HLA-matched related or unrelated donor: the one from~     the Seattle group consisting of 2 Gy TBI with fludarabine (90 mg/m²) versus the one from the~     Stanford group combining 8 Gy TLI with ATG.~   "
225686|NCT00603941|"~     The Phase I/II study will be conducted as an open label, multiple center study of CS-7017, an~     experimental drug and paclitaxel chemotherapy in subjects with advanced anaplastic thyroid~     cancer. Biopsies will be obtained from patients with accessible tumor at baseline, two-weeks~     after the first CS-7017 dosage (prior to the start of combination therapy) and at the end of~     the first study cycle (week 3 of combination therapy), in order to evaluate the effects of~     the study drug alone and in combination with the chemotherapy agent on the tumor. Treatment~     will continue until disease progression or the development of intolerable toxicities.~   "
225687|NCT00603928|"~     Physicians often have an ambivalent relationship to placebo interventions. On the one hand~     they know of the intriguing effect of sugar pills or saline infusions but on the other hand~     they mostly feel constrained to adopt scientifically proven, specific therapies for ethical~     reasons. Against the background of international literature one can assume that also Swiss~     general practitioners use several forms of placebo interventions in a significant part of~     their patients.~      The aim of the project is to ascertain to which extent and in which way Swiss general~     practitioners make use of placebo interventions. Furthermore knowledge of the mode of action~     of placebo interventions and the perceived moral and lawful permissibility of placebo~     interventions and the presumed attitudes of the patients will be investigated.~      The empicical core of the study is a questionnaire survey of general practitioners in urban~     and rural areas of Switzerland. The results and conclusions of the survey will be discussed~     during a workshop with interested GPs, researchers and ethicists.~      The obtained data will lead to a better understanding of the application of placebo~     interventions in the general practice in Switzerland (how often and in which manner,~     accompanied by what information, for which diseases and for which patient groups placebos are~     applied). Moreover the study will help to articulate potential moral ambiguities of~     physicians using placebo interventions.~   "
225688|NCT00603915|"~     Cisplatin or Carboplatin will be given on day 1 every 21 days for 6 cycles; Gemcitabine will~     be given on day 1 and day 8 every 21 days for 6 cycles. Those patients that do not progress~     on GC after 6 cycles of chemotherapy will be started on erlotinib daily until disease~     progression. A cycle of erlotinib will be 28 days. Patients who progress on GC will be~     offered erlotinib as well,in order to evaluate its activity as a single-agent in the~     second-line setting.~      Patients previously treated with GC have reported a progression-free survival (PFS) of 9~     months. We would anticipate an extension of PFS to 12 months in patients treated with GC~     followed by maintenance erlotinib. Furthermore, we hypothesize that patients who achieved~     benefit from GC therapy would have further response when treated with maintenance erlotinib,~     such that this strategy may increase the likelihood of attaining long-term survival.~   "
225689|NCT00603902|"~     The purpose of this study is to assess the weight loss effect of lorcaserin during and at the~     end of 1 year of treatment in overweight and obese patients.~   "
225690|NCT00603889|"~     Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life~     cycle. In a clinical study in previously hookworm-infected adults in Brazil, this protein~     induced urticarial reactions (rash) in a subset of volunteers. This study will evaluate~     solutions of varying concentrations of the protein in both a skin prick-puncture and~     intradermal test that will eventually be used to screen volunteers living in hookworm endemic~     areas who are being considered as potential participants in vaccine trials, to reduce the~     potential of inducing allergic reactions in those vaccinated with the Na-ASP-2 Hookworm~     Vaccine.~   "
225691|NCT00603876|"~     The purpose of the study is to evaluate the effects of 100-110 grams of almonds (about ¾~     cupful) daily on the lipoprotein profile when given to patients on a statin drug. The study~     will compare the effects on the lipoprotein profile to patients who eat almonds and those~     patients not eating almonds.~   "
225692|NCT00603863|"~     This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination~     with gemcitabine in patients with previously untreated pancreatic cancer.~   "
225693|NCT00603850|"~     Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD~     patient to use the HMP device.~   "
225694|NCT00603837|"~     Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will~     not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW)~     babies who are placed on thermal warming blankets.~   "
225796|NCT00602446|"~     RATIONALE: Deferasirox may be effective in treating iron overload caused by blood~     transfusions in patients who have undergone donor stem cell transplant.~      PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in~     treating patients with iron overload after donor stem cell transplant.~   "
225695|NCT00603824|"~     The purpose of this study is to test the safety and efficacy of fondaparinux in patients with~     heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with~     HIT who are treated with fondaparinux experience a prompt and complete recovery of their~     platelet count, and the secondary objective is to determine if any new blood clots are formed~     while receiving the fondaparinux and up to one month after study enrollment. This information~     will be compared to a historical control.~   "
225696|NCT00603811|"~     This study will evaluate the safety and immunogenicity of VAX102 [Flagellin.HuM2e], a~     recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of~     doses.~   "
225697|NCT00603798|"~     The purpose of this study is to determine whether imiquimod creams are effective in treating~     Actinic Keratoses when applied to the face or balding scalp.~      Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the~     sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient~     contained in the study cream for this study is the same as that of the approved product~     Aldara, which has shown to be safe and effective for the treatment of AKs.~   "
225698|NCT00603785|"~     We propose to study the effects of Xolair on patients with chronic sinusitis with or without~     nasal polyps. Because of the similarities between the inflammatory processes found in asthmas~     and rhinitis to those found in chronic sinusitis, we hypothesize that sinusitis should~     respond to Xolair, just as asthma.~   "
225699|NCT00603772|"~     To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic~     reactions, measured as skin reactions following induction and challenge.~   "
225700|NCT00603759|"~     chemotherapy- and radiotherapy-induced oral mucositis represents a therapeutic challenge~     frequently encountered in cancer patients.This side effect causes significant morbidity and~     may delay or interrupt the treatment plan, as well reduce therapeutic index. cyclo-oxygenase~     2 (COX-2) is an inducible enzyme primarily expressed in inflamed tissues and tumor. COX-2~     inhibitors have shown promise as radio- and chemosensitizer and reduce radio-induced~     toxicities.~      we have conducted a phase III, randomized double blind clinical trial to evaluate the~     toxicity and efficacy of celecoxib, a selective COX-2 inhibitor, administered concurrently~     with chemotherapy, and radiation for locally advanced head and neck cancer.~   "
225701|NCT00603746|"~     This study is designed to determine if the investigational drug is effective and safe in~     individuals with asthma.~   "
225702|NCT00603733|"~     The purpose of this study is to demonstrate that the new modified oral extended-release~     Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg~     tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of~     quiescent disease.~   "
225703|NCT00603720|"~     The purpose of this study is to determine, with Positron Emission Tomography (PET), the role~     of nitric oxide in the age-associated effect on fatty acid and glucose delivery on myocardial~     substrate metabolism.~   "
225704|NCT00603707|"~     Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and~     SmartPill) are equivalent and is demonstrated if the study population shows a correlation of~     0.7 or higher.~   "
225705|NCT00603694|"~     Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied~     and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and~     malignant disorders may consequently impair memory function. There is a need to evaluate~     changes in memory function that may be associated with such exposures.~      In this pilot study, we will investigate changes in hippocampal-dependent memory function in~     10 patients receiving a low SRS dose to the hippocampus. We will also investigate such~     changes in a no-dose control group and a high-dose control group. This study will provide~     preliminary estimates of variance in memory changes associated with radiation exposure, and~     will then permit us to design future studies with the appropriate sample size justification.~   "
225706|NCT00603681|"~     The aim of the study is to show that new polyethylene glycol (PEG) solution without~     electrolytes is as effective in the treatment of constipation as PEG solution with~     electrolytes in the elderly institutionalized people. Also, the tolerability and the safety~     of the study drug will be examined.~   "
225707|NCT00603668|"~     This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.~   "
225708|NCT00603655|"~     The aim of this study is to compare the effects of diets with different glycemic load (GL) on~     body composition and biochemical markers in overweight and obese subjects during a 12-month~     period.~   "
225709|NCT00603642|"~     The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with~     placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic~     purpura (ITP) .~   "
225710|NCT00603629|"~     The purpose of this study is to investigate mechanisms which cause acute asthma exacerbations~     by examining blood and airway secretions during an acute onset (sputum or tracheal~     aspirates). This pilot study is intended to uncover new mechanisms of asthma exacerbation and~     to generate hypotheses for future study. By collaborating with Genentech, we (scientists at~     UCSF) plan to incorporate the latest scientific findings into our work to discover and~     develop new treatments for asthma.~   "
225711|NCT00603616|"~     Antibiotics have been used to treat Crohn's disease symptoms with the best studied~     antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is~     FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is~     very poorly absorbed and over 97% of the drug taken orally is excreted in the feces.~      The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for~     the treatment of moderate to severe symptoms of Crohn's Disease.~   "
225712|NCT00603603|"~     Previous studies have demonstrated that patients who undergo surgery while they under general~     anesthesia have fewer wound infections if they receive higher concentrations of oxygen but~     this has never been studied in women who are undergoing cesarean section. We plan to~     randomize women who are undergoing cesarean to receive either standard of care oxygen flow~     through a nasal cannula during their cesarean section only or a higher concentration of~     oxygen than they would typically receive through a face mask. Women will receive this therapy~     during their cesarean and for 2 hours afterwards. We will follow them after their surgery for~     evidence of infection either in their wound or their uterus.~   "
225713|NCT00603590|"~     Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In~     Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are~     consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths~     attributed to cardiovascular events. Cardiovascular diseases will become an increasing~     problem as the Iranian population ages.~      In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose~     combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a~     single preparation. They proposed that this treatment should be offered to all persons at~     high risk of cardiovascular disease whether or not they have elevated blood pressure or~     elevated serum lipid concentrations.~      This pilot study aims to investigate the safety and efficacy of fixed-dose combination~     therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would~     not currently be considered eligible for antihypertensive treatment or for lipid lowering~     treatment.~      Methods:~      This is a double-blind randomized controlled trial. The intervention group will be assigned~     to take a tablet consisting of a single daily tablet comprising Aspirin 81mg,~     Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be~     assigned to an identical placebo.~      The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80~     (inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering~     therapy. Persons who are found at baseline to have blood pressure >160/100 mm Hg, total~     cholesterol >240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore~     lipid lowering therapy are excluded.~      It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome for~     the purpose of sample size calculation is change in systolic blood pressure. Additional~     outcomes include change in diastolic blood pressure, change in LDL cholesterol and occurrence~     of adverse events.~   "
225714|NCT00603577|"~     Primary objective:~      To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate~     of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following~     randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon~     cancer.~      Secondary objective:~        -  To assess the effect of xaliproden on patient-reported outcomes using the Functional~          Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG~          NTX-12 subscale).~        -  To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2~          PSN at 6 months~        -  To assess the effects of xaliproden on the time to complete recovery from PSN~        -  To evaluate the safety profile of xaliproden~   "
225715|NCT00603564|"~     The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2~     administration by a Venturi mask in terms of gas exchanges improvement in patients with acute~     respiratory failure due to community-acquired pneumonia.~   "
225716|NCT00603551|"~     The hypothesis is that postmenopausal women who have received chemotherapy have a greater~     bone loss than the same age controls. The aim of this study is to obtain baseline bone~     mineral density (BMD) data on women with breast and gynecological cancers who have received~     chemotherapy. By comparing the Z scores of postmenopausal women who have received~     chemotherapy with age matched controls this hypothesis can be evaluated. Another goal of the~     study is to compare the T-score of a Heel Bone Density Scan to the T-score of the DXA Scan to~     see if there is a good correlation between peripheral and DXA scores.~   "
225717|NCT00603538|"~     Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination~     with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer~   "
225718|NCT00603525|"~     This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a~     duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the~     study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and~     symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.~   "
225719|NCT00603512|"~     The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4~     dose regimens of CP-690,550, combined with methotrexate, for the treatment with active~     rheumatoid arthritis.~   "
225720|NCT00603499|"~     Objective : to test the BP lowering-effect of oral magnesium supplementation, as magnesium~     chloride (MgCl2) solution, 2.5 g daily, in uncomplicated hypertensive type 2 diabetic~     subjects with decreased serum magnesium levels Design : Randomised double blind placebo~     controlled trial. Setting : Outpatients with type 2 diabetes from Durango, city in northern~     Mexico Subjects : 82 subjects between 40 and 75 years of age with type 2 diabetes serum~     magnesium deficiency and uncomplicated hypertension.~      Interventions : During 4 months the intervention group received 2.5 gr of magnesium chloride~     (50 ml of a solution containing 50 gr of MgCl2 by 1000 ml of solution ). Controls received~     inert placebo.~      Main outcome measure: Change in blood pressure. Increase of serum magnesium Secondary~     outcomes measures: Changes in lipid profile~   "
225721|NCT00603486|"~     The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors~     may be improved with modifications in software and/or hardware monitoring techniques and/or~     accessories. When changes are being made to the GE Monitor, testing can be done to evaluate~     performance of the investigational devices during and/or after product development.~   "
225722|NCT00603473|"~     Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in~     Japanese pediatric patients with partial seizures~   "
225723|NCT00603460|"~     Subjects with recurrent epithelial ovarian carcinoma or primary peritoneal cancer, who have~     previously undergone vaccination in clinical study UPCC-11807 with DCVax-L, an autologous~     vaccine with DC loaded in vitro with autologous tumor lysate.~      Phase I Subjects enrolled in this study will receive leukapheresis; followed by~     cyclophosphamide/fludarabine-induced lymphodepletion; followed by adoptive transfer of ex~     vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells; followed by a~     single DCVax-L vaccination, to establish feasibility and safety of this approach.~      Primary Objectives of Phase I~      To determine the feasibility and safety of administering vaccine-primed, ex vivo~     CD3/CD28-costimulated autologous peripheral blood T cells in combination with DCVax-L~     vaccination, following lymphodepletion with high dose cyclophosphamide/fludarabine.~      Phase II~      Twenty-two additional subjects will be randomized to receive either:~        -  ARM-IIA: maintenance DCVax-L vaccination, in combination with oral metronomic~          cyclophosphamide, or~        -  ARM-IIB: leukapheresis, followed by cyclophosphamide/fludarabine-induced~          lymphodepletion, followed by adoptive transfer of ex vivo CD3/CD28-costimulated~          vaccine-primed peripheral blood autologous T cells, followed by maintenance DCVax-L~          vaccination, plus oral metronomic cyclophosphamide.~      Primary Objective of Phase II~      To assess the distribution of progression-free survival at 6 months for patients treated with~     maintenance DCVax-L vaccination plus oral metronomic cyclophosphamide as well as patients~     treated with ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells~     after lymphodepletion with high dose cyclophosphamide / fludarabine, followed by DCVax-L~     boost vaccination and metronomic oral cyclophosphamide.~   "
225725|NCT00603434|"~     This is a human inpatient clinical pharmacology study to assess potential interactions~     between intravenous (i.v.) methamphetamine infusion and oral osmotic release methylphenidate~     (OROS-MPH). The primary objective of this study is to determine the safety of the OROS-MPH~     concurrent with i.v. d-methamphetamine infusions of 15 mg and 30 mg. Safety outcome measures~     include cardiovascular responses [heart rate (HR), blood pressure (BP), and~     electrocardiograph (ECG) measurements], oral temperature, adverse events (AEs), and clinical~     laboratory analyses.~   "
225726|NCT00603421|"~     This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line~     on the rate of suicide attempts and self-injurious behaviors in borderline patients.~   "
225727|NCT00603408|"~     The purpose of this study is to determine whether Cisplatin when given with radiation therapy~     prior to surgery is effective in improving response to treatment in breast cancer patients.~     Tumor, blood and bone marrow samples will be collected in this study and will also help~     researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself~     and create more tumor cells, and cause the tumor cells to die.~   "
225728|NCT00603395|"~     This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip~     Resurfacing System.~   "
225729|NCT00603382|"~     This study is designed to determine if the investigational drug is effective and safe in~     individuals with asthma.~   "
225730|NCT00603369|"~     One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders.~     Furthermore, those with histories of sexual abuse have been found to have riskier attitudes,~     poorer sexual communication skills, and less consistent condom use than non-abused peers.~     This study implemented and evaluated interventions for adolescents in intensive psychiatric~     treatment settings, particularly those with histories of sexual abuse. It is hypothesized~     that those participating in the intervention that addresses affect management and cognitive~     monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest~     than peers in an information-based intervention.~   "
225731|NCT00603356|"~     This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.~   "
225732|NCT00603343|"~     The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the~     antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic~     overactive bladder and urinary incontinence.~   "
225733|NCT00603330|"~     The present project aims at investigating the role of MSC for the treatment of patients with~      Part 1: Steroid-refractory grade II-IV acute GVHD.~      Part 2: Poor graft function (PGF)~      Part 3: Low or falling donor T-cell chimerism after allogeneic HCT.~      This is a multicenter phase II study examining the feasibility and efficacy of this approach.~   "
225734|NCT00603317|"~     Several case reports indicate that the use of the antibiotic combination amoxicillin and~     clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per~     se might also be responsible of these warfarin overdose reports, as well as the use of high~     dose paracetamol.~      The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics~     of warfarin among patients at steady state Double blinded cross over controlled study vs~     placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3~     and a stable INR and a stable dose.~   "
225735|NCT00603304|"~     The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the~     CAMUS trial will be given one out of two possible treatments at random. One out of every two~     men would get an inactive placebo treatment. One out of every two men would get Saw palmetto~     pills.~      This kind of scientific study is the best way to find out if the plant extracts really work~     to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study,~     men will not know which of the two treatments they are assigned to. They will be followed~     very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial~     will be studied over 72 weeks. Tests and all medications needed as part of the study will be~     provided at no charge to the participant. Participants will be responsible for all other~     costs not associated with the study tests and medications. All information on study~     participants will be held in the strictest confidence and no one would have access to patient~     information other than the required authorized health care and research personnel.~   "
225736|NCT00603291|"~     The purpose of this study is to assess the weight loss effect of lorcaserin during and at the~     end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus~     treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral~     hypoglycemic agents.~   "
225737|NCT00603278|"~     This study is designed to determine if the investigational drug is effective and safe in~     individuals with asthma.~   "
225738|NCT00603265|"~     The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving the pain~     associated with diabetic peripheral neuropathy (DPN) compared with placebo and duloxetine (a~     marketed drug approved for the treatment of painful DPN). The pain symptoms of DPN are~     thought to be due to damage to nerves caused by the diabetes.~   "
225739|NCT00603252|"~     This protocol posting describes the booster phase of the study. The objectives & outcome~     measures of the primary phase are presented in a separate protocol posting (NCT number =~     NCT00289731).~   "
225740|NCT00603239|"~     This study will assess safety and efficacy of exenatide in combination with a~     thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2~     diabetes who have not achieved adequate glycemic control.~   "
225741|NCT00603226|"~     To compare patients with Slow Coronary Artery Flow to patients with normal flow and to~     determine whether there is a difference in their future incidence of heart disease.~   "
225742|NCT00603213|"~     Congestive heart failure is a condition in which the heart is weakened and is unable to pump~     enough blood to the organs of the body to meet the demands of the body. At times there may be~     a buildup of fluid in the lungs, legs or other parts of the body. The accumulation of this~     fluid has been shown to affect the resistance to flow of the electrical impulses generated in~     the heart. The purpose of this study is to correlate measurements to the passive flow of~     electricity generated by the heart within the chest (as measured by the Optivol TFS System)~     with measurements of the volume of blood in the body.~   "
229054|NCT00558831|"~     The purpose of this study is to compare the efficacy of a benzoyl peroxide 2.5% cream~     formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for the~     treatment of acne vulgaris.~   "
225745|NCT00603174|"~     The present protocol will demonstrate the feasibility and efficacy of a newly developed mode~     of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA.~     During NAVA, the timing and magnitude of pressure delivered are controlled by the infants'~     diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive.~     Recent clinical trials in adults and term infants have shown that NAVA is more synchronous~     than conventional pressure support ventilation, and that NAVA delivers lower mean airway~     pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently~     been approved for use in infants by Health Canada and the FDA in the United States, and is~     commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The~     present protocol is designed as a case study where the researchers responsible would like~     to evaluate the feasibility and efficacy of ventilating an infant on NAVA with the Servoi for~     12 hours, and to compare it to conventional ventilation.~   "
225746|NCT00603148|"~     This study will begin to define these critical determinants for patients undergoing~     procedures in the hybrid interventional cardiology/cardiac surgery suite. In future studies,~     the data obtained from this study will be used to prospectively stratify patients in terms of~     bleeding verses thrombotic risk to design studies to optimize anticoagulation and~     anti-platelet therapies in the hybrid setting.~   "
225747|NCT00603135|"~     Status epilepticus (SE) represents the most common life-threatening neurological emergency~     requiring treatment on an intensive care unit. The incidence in Western European countries is~     about 12-18/100'000. Immediate and effective treatment of SE is obviously essential because~     of the deleterious effects of continuous seizures on the brain and the whole organism.~     Guidelines emphasize the use of benzodiazepines (BZD) as first-line anticonvulsive drugs.~     Alternatively, i/v Phenytoin (PHE), fosphenytoin (FOS), and valproate (VPA) were also tested~     as first-line anticonvulsants in SE. Direct comparison of PHE with lorazepam (LZP) showed~     significant superiority of LZP (evidence class I). Other trials i/v PHE or -VPA are of~     evidence class III or IV. BZD, VPA, and PHE have clinical and pharmacological disadvantages.~     BZD may cause respiratory depression or sedation and may be not suitable for patients with~     COPD or ambiguous in patients with BZD addiction. Some compounds also may induce~     tachyphylaxis or accumulate under concomitant renal failure. PHE has saturable metabolism~     subject to Michaelis-Menten kinetics increasing the risk of overdosing in an acute setting~     causing liver damage, serious cardiac arrhythmias, hypotension, cerebellar degeneration,~     peripheral neuropathy and local/systemic skin reactions. Although of unequivocal efficacy,~     PHE should no longer be used for long-term because of its adverse effects after chronic~     administration (irreversible cerebellar degeneration causing debilitating ataxia, painful~     polyneuropathy, and osteopenia increasing the risk of fractures). Metabolism by and~     self-induction of the hepatic CYP450 system make PHE prone to interactions with several other~     drugs, notably other antiepileptics. VPA may cause liver failure, hemorrhagic complications,~     pancreatitis, and hyperammonemic encephalopathy. To summarize, these three first-line agents~     for the treatment of SE may cause serious side effects in several patients with SE.~      Levetiracetam (LEV) is broad-spectrum antiepileptic drug. It binds to the presynaptic~     vesicular protein 2A abundantly present in different regions of the brain; LEV~     presynaptically modulates transmitter release, but the exact mechanism(s) remain unclear.~     Data also revealed that LEV stabilizes GABAA receptors upon repetitive activation what is~     important in treatment of SE because GABAA receptors undergo significant changes of subunit~     conformation within minutes after sustained activation like during SE. These changes render~     GABAA receptors the less anticonvulsive, the longer SE lasts. Levetiracetam has a favorable~     pharmacological profile with large safety margins. Its partly extrahepatic hydrolyzation~     bypasses the CYP450 system; renal excretion is 60-70% unchanged, and 23-27% metabolized.~     Dosage needs adjustment when renal function is impaired. LEV lacks interactions with any~     drugs yet. Drowsiness is the most common side-effect while respiration, liver and kidney~     function, and the blood system are not affected. LEV shows an important clinical effect even~     after the first dose and maximal efficacy within the first week of drug-intake. The favorable~     clinico-pharmacological profile predilects LEV for the first-line treatment of SE, especially~     in patients with multi-organ failure, sepsis, coma etc.. About 10 % of comatous patients may~     be in non-convulsive SE (NCSE) on ICU's. These patients are under polymedication whereby~     interactions of the anticonvulsants approved yet for the treatment of NCSE with their other~     drugs may have fatal effects. Conversely, non-interacting anticonvulsants would represent an~     advantage for the treatment of NCSE for these patients.~      Recently, the i/v formulation of LEV was approved by the FDA for the use in patients, but not~     specifically for the treatment of SE. Data about the single-dose bioavailability of i/v-LEV~     in comparison to oral tablets as well as multiple-dose pharmacokinetics and tolerability in~     healthy subjects were recently published. In addition, the administration of i/v-LEV dosages~     ranging from 2000-4000 mg within 15 minutes and of dosages ranging from 1500-2500 mg within 5~     minutes was safe and well tolerated, and led to efficacious drug levels in a randomized,~     single-blind, placebo-controlled safety and pharmacokinetic study in healthy volunteers.~      Slight somnolence is expected to be the only adverse effect of i/v LEV, sharply contrasting~     with the sedation up to coma after i/v benzodiazepines. Thus, even severely ill patients will~     be accessible to neurological tests under LEV which is a big advantage in this clinical~     difficult setting of NCSE.~      I-v LEV is considered an ideal candidate for the first-line use (before benzodiazepines) in~     patients with NCSE, especially in those with important comorbidity and concomitant~     polymedication. Thus, we would like to test the feasibility, safety, and efficacy of i/v-LEV~     as first-line medication in a open-label, single-center, prospective pilot study as outlined~     below.~   "
225748|NCT00603122|"~     The trial evaluates the role of ascent protocol on acute mountain sickness and~     cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of~     mountaineers ascend with different acclimatization time to the summit. The prevalence and~     severity of symptoms of acute mountain sickness are evaluated along with physiologic~     variables.~   "
225749|NCT00603109|"~     The purpose of this study is to evaluate the effect of rimonabant, a cannabinoid receptor-1~     blocking drug, on the appetite, body weight, body fat and growth hormone level of subjects~     with Prader-Willi Syndrome (PWS). This will be a double blind placebo controlled clinical~     trial involving a total of 18 young adults aged 18 to 35 years with PWS. Patients will be~     divided in to the two groups of control and intervention, and treated with either placebo~     (inactive drug), or rimonabant 20 mg once a day for a total duration of 6 months. Body~     weight, fat distribution, objective and subjective assessment of the hunger, fasting blood~     sample for measurement of ghrelin and leptin (two hormones regulating appetite), serum lipids~     , IGF-1(growth hormone related protein), insulin and glucose concentrations will be measured~     upon enrollment, at 3 months, and at the end of the study. The proportion of body fat to~     muscle will be determined using a radiological technique, whole body dual-energy x-ray~     absorptiometry (DEXA) scan, and also by measurement of skin fold thickness, waist and hip~     circumference at the enrollment prior to the intervention, and at the end of the study.~   "
225750|NCT00603096|"~     The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in~     OHS patients after one month of NIV treatment depending upon the tools used for adjusting~     settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at~     awakening whereas in the other arm patients will benefit from a complete polysomnography~     under NIV.~   "
225751|NCT00603083|"~     The purpose of this study is to determine whether the investigator standardized pain~     treatment plus local pain treatment is more effective than the investigator standardized pain~     treatment plus placebo in total hip arthroplasty.~   "
225752|NCT00603070|"~     The purpose of this study is twofold:~        1. to measure the effects of transitioning from one electronic prescribing system to~          another in the ambulatory setting on medication errors and human-computer interactions~        2. to evaluate the impact of electronic transmission of discharge medication lists to the~          ambulatory setting on medication discrepancies and adverse drug events~   "
225753|NCT00603057|"~     Successful treatment of non-small cell lung cancer with radiation therapy requires that the~     physicians determine exactly where the tumor is in your body and protect your normal tissue.~     This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission~     Tomography (FDG-PET) and Ventilation/Perfusion Single Photon Emission Computerized Tomography~     (V/Q SPECT), before treatment and then again during treatment to see if it helps predict how~     well the treatment works for your cancer and how well your lung functions during treatment. A~     Computerized Tomography (CT) will also be performed along with both of these procedures to~     help the researchers see clearly where your cancer or your healthy lung is located.~      The researchers are also doing blood tests in this study to look for markers in your blood~     and to see if it helps them in determining your risk of developing side effects from~     radiation to the lungs. The researchers hope that this study will help them in the future to~     design radiation treatment plans that provide the best treatment for each individual patient.~   "
225754|NCT00603044|"~     The purpose of this research is to find out how a nasal spray (fluticasone furoate),~     sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain~     cells within a child's adenoids. We hypothesize that intranasal steroids lead to an~     upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will~     result in a local reduction in inflammation and edema explaining the improvement in OSAS.~   "
225755|NCT00603031|"~     study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal~     stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified~     as having no residual beta cell function left.~   "
225756|NCT00603018|"~     Several studies in the past suggest that individuals who have or had anorexia nervosa may~     have alterations in brain serotonin. Serotonin seems to play an important role in regulating~     anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology~     called Positron Emission Tomography (PET), which is a method used to take pictures of the~     body, in this case, the brain. Study participants will undergo two baseline PET scans on the~     first day of the study. The women who have recovered from anorexia will then be given a~     medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th~     week, they will return for a third PET scan. By comparing the brain scans, before and after~     fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the~     serotonin receptors in the brain. We will be comparing brain serotonin system in women who~     have recovered from anorexia before and after medication in order to gain a better~     understanding of changes in the serotonin system associated with eating disorders. This study~     may help shed light on how to make fluoxetine a more effective treatment for anorexia~     nervosa.~   "
225758|NCT00602992|"~     Gamma Knife radiosurgery is a non-invasive technique for the delivery of a single, high dose~     of radiation to an intra-cranial target. MRI has an established and central role in the~     treatment planning process and assessment of response to intracranial radiosurgery.~     Increasing the field strength of MRI from 1.5T to 3T promises to improve the signal, and in~     turn the quality of images. However, the technology also introduces new limitations, and the~     role and safety of 3T MRI in the management of patients receiving radiosurgery has not yet~     been reported. In this pilot study, we will explore the spatial integrity, and incremental~     image-guidance utility of 3T MRI in patients receiving radiosurgery. The preliminary data~     acquired in this study will be instrumental to the judicious design and conduct of subsequent~     definitive clinical trials. Up to fifty patients will be enrolled in this study.~   "
225759|NCT00602979|"~     The placement of endotracheal tubes (intubation) is a physiologically stressful procedure for~     patients. Laryngoscopes are devices-typically composed of a blade attached to a handle with a~     light source—that allow examination of the upper airway through the mouth, often for the~     purposes of intubation. Recently some new laryngoscope devices (including the Airtraq®~     Optical Laryngoscope, the Storz DCI Video laryngoscope®, McGRATH® Video Laryngoscope, and the~     GlideScope®) have been developed, which may either decrease the stress related to intubation~     (reduce neck extension, reduce risk of complications or reduce time elapsed during~     intubation) or improve intubation success (reduce the number of attempts at intubating). Data~     are being collected in this study to determine which of these commonly-used devices may be~     better, particularly in comparison to the current hospital standard, the Macintosh~     laryngoscope. All of the devices to be used in this study are currently cleared or exempt by~     the Food and Drug Administration (FDA).~   "
225760|NCT00602966|"~     Oocyte cryopreservation has been studied for many years without much success in refining a~     method that has consistent, reliable results in producing viable embryos and clinical~     pregnancies. In 1986 the first baby was born from an embryo created from a frozen oocyte;~     however, since then there have been less than 150 births from frozen eggs. To date, there are~     no reportable adverse outcomes in the children born from frozen oocytes. The research~     continues to look at different methods of oocyte cryopreservation. Many smaller studies have~     been conducted with some success but larger clinical trials are needed to replicate these~     findings. The conventional cryopreservation technique has been slow cooling with differing~     methods of freezing; however, vitrification is now being researched as the potential~     cryopreserving method that holds some promise for the future.~      Our hypothesis is the use of vitrification (quick freezing) to cryopreserve oocytes in~     patients undergoing in-vitro fertilization will be more successful than slow freezing in~     oocyte survival, fertilization rate with ICSI and subsequent embryo development, implantation~     rate and pregnancy rate.~   "
225761|NCT00602953|"~     The study evaluates if fat accumulates in the pancreas in individuals at risk of developing~     obesity-related diabetes. It also evaluates if the amount of fat in the pancreas can predict~     the residual functional capacity of the pancreas (insulin secretion).~   "
225762|NCT00602940|"~     This is a randomized control trial of acupuncture for women with polycystic ovary syndrome.~     The study is triple-blinded.~   "
225763|NCT00602927|"~     This project aims to define mechanisms through which varenicline might be an effective~     smoking cessation medication.~   "
225764|NCT00602914|"~     The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics~     injected via the MicronJet in comparison with a conventional needle.~   "
225765|NCT00602901|"~     The purpose of this study is to compare the clinical effectiveness of two types of~     chiropractic spinal manipulation to conservative medical care for patients at least 55 years~     old with sub-acute or chronic low back pain (LBP).~   "
225766|NCT00602862|"~     Sorafenib is a tyrosine kinase inhibitor that is registered for the treatment of metastasized~     clear cell Renal Cell Carcinoma (ccRCC). It inhibits signal transduction of the Vascular~     Endothelial Growth Factor Receptor (VEGFR) and the Platelet Derived Growth Factor Receptor~     (PDGFR). In the tumorigenesis of ccRCC, VEGF and PDGF are upregulated due to the defective~     Von-Hippel-Lindau (VHL) gene. CcRCC has a high Interstitial Fluid Pressure (IFP) and Tumor~     Microvascular Density (TMD), hampering the delivery of chemotherapeutics and monoclonal~     antibodies (mAbs). It was hypothesized that antiangiogenic compounds decrease tumor IFP and~     TMD, thus normalizing tumor vasculature, before diminishing tumor vasculature. Bevacizumab is~     an anti-VEGF mAb which depletes soluble VEGF from plasma, depriving VEGFR of its ligand.~     Chimeric monoclonal antibody cG250 recognizes carbonic anhydrase IX (CAIX), an antigen that~     is abundantly expressed in Renal Cell Carcinoma (RCC) and has limited expression in normal~     tissue. The aim of this study was to investigate the effect of Sorafenib on ccRCC physiology,~     by determining tumor uptake of 111In labeled cG250 or 111In labeled Bevacizumab.~   "
225767|NCT00602849|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline~     Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fasting conditions using a~     single-dose, 2-treatment, 2-period, crossover design.~   "
225768|NCT00602836|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving~     rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with pentostatin,~     cyclophosphamide, and lenalidomide works in treating patients with previously untreated~     B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.~   "
225797|NCT00602433|"~     Studying samples of blood in the laboratory from patients receiving erlotinib may help~     doctors learn more about the effects of erlotinib on hormone levels.~      This clinical trial is looking at hormone changes in women with stage IIIB or stage IV~     non-small cell lung cancer receiving erlotinib.~   "
225832|NCT00601952|"~     The purpose of this study is to determine whether a computerized intervention designed to~     change the nature of attention biases will be effective in reducing the symptoms of post~     traumatic stress disorder (PTSD) in American combat veterans returning from the wars in~     Afghanistan and Iraq.~   "
225769|NCT00602823|"~     The pathogenesis of psoriasis has evolved from epidermal hyperproliferation to immune~     dysregulation in recent years. A Th1 cytokine profile is universally found is psoriasis.~     Biologics targeting the immune system have become the focus of study. Raptiva (Efalizumab) is~     one of biologics indicated for the treatment of psoriasis, and is the first biologic approved~     for use in psoriasis in the EU (EMEA). In USA, it is the second biologic drug (after Amevive)~     for psoriasis. Raptiva is a humanized chimeric antibody of CD11a (LFA-1), which blocks the~     interaction of CD11and ICAM─1, thus preventing lymphocyte trafficking. It is used for~     moderate to severe chronic plaque type psoraisis. The first clinical trial of Raptiva in~     Asians iscurrently done in the department of Dermatology, National Taiwan University Hospital~     and the incidence of psoriatic arthritis (either de novo or aggravation of preexisting~     psoriatic arthritis) is significantly higher than previously reported in Western~     countries（30％ versus 7%，and personal communication with doctors in Hong-Kong and Singapore~     also reveals a similar safety profile. It seems likely that a racial difference is present.~     Monocytes play a central role in the pathogenesis of psoriatic arthritis. It is thus~     intriguing to study the pathogenesis of Raptiva-induced aggravation of psoriatic arthritis by~     comparing the difference of monocyes response in the presence of Raptiva between patients~     with and without Raptiva-induced psoriatic arthritis. In further study, the CD11a genomic~     polymorphism will also be investigated. The suudy can provide us with important information~     on how a novel monoclonal antibody like Raptiva can have both therapeutic and detrimental~     actions on psoriasis. The short term benefit of the study will be in pharmacogenomics and~     pharmacoeconomics, finding the best candidates for the expensive drug. The long term goal~     will be the clarification of the pathogenesis of psoriasis and psoriatic arthritis.~   "
225770|NCT00602797|"~     This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel~     works in treating older patients with non-small cell lung cancer that has spread to other~     placed in the body. Drugs used in chemotherapy, such as vinorelbine tartrate and paclitaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving combination~     chemotherapy may kill more tumor cells.~   "
225771|NCT00602784|"~     The objectives are~        1. to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization~          with HCV antigen peptide vaccine with polyarginine.~        2. to document virological (HCV-RNA) and biochemical (ALT) responses following immunization~          with HCV antigen peptide vaccine with polyarginine.~        3. to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.~   "
225772|NCT00602771|"~     This randomized phase II trial is studying the side effects and how well giving tipifarnib~     together with etoposide works in treating older patients with newly diagnosed, previously~     untreated acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer~     cells.~   "
225773|NCT00602758|"~     This study will compare the effectiveness of enhanced counseling alone versus enhanced~     counseling combined with observed therapy at improving medication adherence in people with~     HIV.~   "
225774|NCT00602745|"~     The primary objective of this study is to determine whether S-1 increases overall survival~     when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer~     previously treated with a gemcitabine-based therapy.~      The secondary objectives are to compare: progression free survival, overall response rate,~     clinical benefit and improvement in tumor related symptoms and also to assess overall safety~     and pharmacokinetics of S-1.~   "
225775|NCT00602732|"~     This study will evaluate the effectiveness of an interpersonally oriented treatment program~     called Reach Out for a Safe Environment in preventing depression and post-traumatic stress~     disorder in low-income pregnant women who have experienced recent partner abuse.~   "
225776|NCT00602719|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem~     Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using~     a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
225777|NCT00602706|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the~     growth of cancer cells either by killing the cells or by stopping them from dividing.~     Samarium Sm 153 lexidronam pentasodium contains a radioactive substance that kill cancer~     cells. Peripheral blood stem cell transplant using stem cells from the patient may be able to~     replace immune cells that were destroyed by chemotherapy and radioactive drugs used to kill~     cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153~     lexidronam pentasodium when given together with high-dose melphalan in treating patients with~     multiple myeloma undergoing stem cell transplant.~   "
225778|NCT00602693|"~     RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body~     irradiation before a donor umbilical cord blood transplant helps stop the patient's immune~     system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Giving an infusion of the donor's T-regulatory cells after the transplant may~     decrease this effect. Sometimes the transplanted cells from a donor can also make an immune~     response against the body's normal cells. However, the donor immune system may also react~     against the recipient's tissues (graft-versus-host disease).~      PURPOSE: This phase I trial is studying the side effects and best dose of donor T-regulatory~     cells after an umbilical cord blood transplant in treating patients with advanced hematologic~     cancer or other disorder.~   "
225779|NCT00602680|"~     The primary objective of the study is to assess the effect of 3 doses of SSR180711C on~     cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to~     assess the safety/tolerability of SSR180711C in patients with mild AD.~   "
225780|NCT00602667|"~     RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat~     brain tumors in young children. Using chemotherapy gives the brain more time to develop~     before radiation is given. The chemotherapy in this study includes the drug methotrexate.~     This drug was an important part of the two clinical trials which resulted in the best~     survival results for children less than 3 years of age with medulloblastoma. Most patients~     treated on this trial will also receive radiation which is carefully targeted to the area of~     the tumor. This type of radiation (focal conformal or proton beam radiotherapy) may result in~     fewer problems with thinking and learning than radiation to the whole brain and spinal cord.~      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together~     with radiation therapy works in treating young patients with newly diagnosed central nervous~     system tumors.~   "
225781|NCT00602641|"~     This randomized phase III trial studies melphalan and prednisone with thalidomide to see how~     well it works compared to melphalan and prednisone together with lenalidomide in treating~     patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan~     and prednisone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide~     and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the~     cancer. It is not yet known whether melphalan and prednisone are more effective when given~     together with thalidomide or lenalidomide in treating multiple myeloma.~   "
225782|NCT00602628|"~     RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging and CT~     scans, may help reduce normal tissue damage in patients undergoing radiation therapy for~     cancer.~      PURPOSE: This clinical trial is studying how well radiation therapy planning techniques work~     in reducing damage to normal tissue in women undergoing breast-conserving surgery for ductal~     breast carcinoma.~   "
225783|NCT00602615|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide~     Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fed conditions using a single-dose,~     2-treatment, 2-period, crossover design.~   "
225784|NCT00602602|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with combination~     chemotherapy and radiation therapy may kill more tumor cells.~      PURPOSE: The phase II trial is studying the side effects and how well giving bevacizumab~     together with gemcitabine, oxaliplatin, fluorouracil, and radiation therapy works in treating~     patients undergoing surgery for locally advanced pancreatic cancer.~   "
225785|NCT00602589|"~     The primary objective of the study was to assess the bioequivalence of the oral suspension~     formulation, the oral solution formulation, and the marketed tablet formulation of~     levofloxacin, with the marketed tablet as the reference.~   "
225786|NCT00602576|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. Giving temozolomide together with sorafenib~     may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying two different schedules of temozolomide~     when given together with sorafenib to compare how well they work in treating patients with~     metastatic or unresectable melanoma.~   "
225787|NCT00602563|"~     Generalized Anxiety Disorder (GAD) has high prelevance (up to 8.5%; Roy-Byrne & Wagner, 2004)~     and leads to functional impairment (Wittchen et al., 2002; Ballenger et al., 2001).~     Researchers have demonstrated a relationship between attention bias to threatening~     information and GAD. However, this knowledge has not yet been translated into effective~     treatments. The goal of this project is develop and test a new computerized treatment for~     Generalized Anxiety Disorder.~   "
225788|NCT00602550|"~     The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg~     tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a~     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
225789|NCT00602537|"~     This study will compare the safety and effectiveness of antidepressant therapy versus mood~     stabilizing therapy in treating people with bipolar type II major depression.~   "
225790|NCT00602524|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine~     tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fasting conditions using a~     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
225791|NCT00602511|"~     The purpose of the study is to compare thalidomide + dexamethasone with bortezomib +~     dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main~     goal is to find out which of these two 2:nd line regimens that offers the patients the best~     chance for a response with as long duration and as good quality of life as possible.~   "
225792|NCT00602498|"~     The objective of this study was the bioequivalence of a potential generic 500 mg~     clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin~     tablet, Biaxin® following a single 500 mg dose, administered with food.~   "
225793|NCT00602485|"~     This will be a pilot study of the effect of an Action Control-based intervention (ACBI) on~     adherence to prescribed diet and exercise programs after cardaic rehabilitation. The purposes~     of this study are to:~        1. determine if an ACBI has an effect on adherence to prescribed home exercise and diet~          regimens for individuals 6 weeks after participating in a cardiac rehabilitation program~        2. examine whether there is a difference in response to the ACBI between state-oriented~          individuals and action-oriented individuals.~        3. test the interaction effect between action-orientation disposition and the intervention.~   "
225794|NCT00602472|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to~     metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with~     insufficient glycaemic control.~   "
225795|NCT00602459|"~     This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and~     rituximab with or without lenalidomide or cyclophosphamide work in treating patients with~     symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine~     phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different~     ways by targeting certain cells. Lenalidomide may stimulate the immune system in different~     ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together~     with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic~     leukemia.~   "
225833|NCT00601939|"~     This study will evaluate the effectiveness of culturally competent psychoeducational~     empowerment sessions in treating suicidal African-American women who are in abusive~     relationships.~   "
225798|NCT00602420|"~     RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not~     yet known whether naproxen is more effective than a placebo in preventing bone pain caused by~     pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.~      PURPOSE: This randomized phase III trial is studying naproxen to see how well it works~     compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with~     non-hematologic cancer undergoing chemotherapy.~   "
225799|NCT00602407|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol~     Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions~     using a single-dose, randomized, 2-treatment, 2-period, crossover design.~   "
225800|NCT00602394|"~     The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg~     extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release~     tablet under fed conditions using a single-dose, randomized, 2 treatment, 2-period,~     2-sequence crossover design.~   "
225801|NCT00602381|"~     The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate~     450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg~     extended release tablet under fasting conditions using a single-dose, randomized,~     three-treatment, three-period, six-sequence crossover design.~   "
225802|NCT00602368|"~     RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and~     diagnose cervical intraepithelial neoplasia.~      PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in~     finding cervical intraepithelial neoplasia.~   "
225803|NCT00602355|"~     This study will evaluate the effectiveness of antidepressant medication alone and~     interpersonal psychotherapy alone in treating women with postpartum depression.~   "
225804|NCT00602342|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine~     tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under~     fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence~     crossover design.~   "
225805|NCT00602329|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab~     may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving~     bevacizumab together with combination chemotherapy may kill more tumor cells. Diagnostic~     procedures, such as MRI, may help doctors predict a patient's response to treatment and help~     plan the best treatment.~      PURPOSE: This randomized phase II trial is studying how well MRI works in predicting response~     to combination chemotherapy given together with bevacizumab in treating patients with~     advanced or metastatic colorectal cancer.~   "
225806|NCT00602316|"~     RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging, may~     help doctors learn the extent of disease and plan the best treatment.~      PURPOSE: This clinical trial is studying how well multifunctional magnetic resonance imaging~     works in predicting breast lesions in women undergoing mastectomy for breast cancer.~   "
225807|NCT00602303|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide~     Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting conditions using a~     single-dose, 2-treatment, 2-period, crossover design.~   "
225808|NCT00602290|"~     This study will evaluate the safety and effectiveness of methylphenidate in improving~     cognition and function in older adults with depression.~   "
225809|NCT00602277|"~     This phase I/II trial is studying the side effects and best dose of viral therapy in treating~     patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer~     that did not respond to platinum chemotherapy (phase II closed as of 1/7/2011). Viral therapy~     may be able to kill tumor cells without damaging normal cells.~   "
225810|NCT00602264|"~     The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and~     ghrelin in different stages of anorectic patients and to evaluate their relationships between~     biochemical, hormonal and anthropometric parameters.~   "
225811|NCT00602251|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine~     tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fed~     conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover~     design.~   "
225812|NCT00602225|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or stopping them from~     dividing. Colony stimulating factors, such as G-CSF, may increase the number of immune cells~     found in bone marrow or peripheral blood and may help the immune system recover from the side~     effects of chemotherapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine to see~     how well it works when given together with cytarabine and G-CSF in treating patients with~     relapsed or refractory acute myeloid leukemia~   "
225828|NCT00602004|"~     The primary objective is to determine if the use of losartan, an angiotensin II receptor~     blocker, can attenuate left ventricular hypertrophy, independent of its antihypertensive~     effects, in patients with near end stage chronic kidney disease (CKD) who have an~     arteriovenous fistula created.~      Secondary outcomes include the impact of the medication on BNP and hyperkalaemia~   "
225829|NCT00601991|"~     RATIONALE: Aflibercept may stop the growth of cancer cells by blocking blood flow to the~     cancer.~      PURPOSE: This phase II trial is studying how well aflibercept works in treating patients with~     advanced refractory, relapsed, or untreated acute myeloid leukemia.~   "
225830|NCT00601978|"~     This study will evaluate the effects of immediate release (IR) carbidopa levodopa versus the~     effects of immediate-release carbidopa/levodopa on ERP parameters in patients with idiopathic~     PD.~   "
225831|NCT00601965|"~     This study will assess whether adding cognitive behavioral therapy to the antidepressant~     escitalopram is effective in reducing anxiety in older adults with generalized anxiety~     disorder.~   "
225917|NCT00600821|"~     To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with~     advanced lung cancer who have not been previously treated.~   "
225813|NCT00602212|"~     Generalized Anxiety Disorder (GAD) is a psychiatric disease characterized by long-lasting~     anxiety that is not focused on a specific object or situation. According to the DSM-IV-TR the~     essential feature of GAD is at least six months of excessive anxiety and worry about a~     variety of events and situations. Anxiety and worry are often accompanied by a variety of~     physical symptoms like restlessness, being easily fatigued, difficulty concentrating,~     irritability, muscle tension and disturbed sleep. The high prevalence of GAD in the general~     population and the severe limitations it causes point out the necessity to find new~     strategies to treat it in a more efficient way. Within the treatment of GAD, physical~     (relaxation and controlled breathing), behavioral (visualization and controlled exposure) and~     cognitive control strategies (challenging negative thoughts) represent a key part of the~     treatment, even if they are hard to be learned. Given the features of this disease and its~     pervasive effect on patient's personal, occupational and affective life, we thought it could~     benefit from an ubiquitous treatment.We suggested, then, to improve the treatment of GAD~     through the use of a biofeedback enhanced virtual reality (VR) system used for relaxation,~     controlled exposure and SIT. The use of SIT in the context of GAD is motivated by the~     acknowledgment that sometimes stressors can't be avoided or altered and then patients can't~     apply strategies focused on finding solutions. In these instances, coping effort should be~     directed to emotionally palliative set of responses such as acceptance, reframing and~     perspective thinking. All these cognitive changes are facilitated if a concomitant relaxation~     is induced. The treatment involves two virtual reality components:~      I) an immersive virtual reality system experienced in the therapist's office;~      II) a mobile exposure system allowing patients to perform the virtual experience in an~     outpatient setting. The role of the mobile exposure system is the following:~        -  To present and structure emotionally relevant contents in an ubiquitous context.~        -  To verify the compliance of the patient and eventually alert patient/therapist;~        -  To track in real-time the emotional level of the patient and record it for later~          assessment by the therapist;~        -  To provide a feedback to the patient able to help him in coping with the contents;~        -  To automatically contact the therapist if the emotional level is higher than a preset~          cut-off value defined by the therapist.~   "
225814|NCT00602199|"~     RATIONALE: ABT-510 may stop the growth of melanoma by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well giving ABT-510 works in treating patients~     with metastatic melanoma.~   "
225815|NCT00602186|"~     The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the~     treatment of female voiding dysfunction(BOO)~   "
225816|NCT00602173|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol~     Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions~     using a single-dose, randomized, 3-treatment, 3-period, crossover design.~   "
225817|NCT00602160|"~     The increasing prevalence of allergic diseases in westernized countries poses a significant~     health problem and a tremendous burden on quality of life and healthcare expenditure. Food~     allergy affects as many as 6% of young children and 3% to 4% of adults. While the majority of~     children outgrow their allergy to milk, egg, wheat and soy, allergies to peanut, tree nuts,~     fish and shellfish are often life-long. Currently, there are no treatments that can cure or~     provide long-term remission from food allergy. Based on our preliminary studies, we~     hypothesize that our investigational botanical drug, FAHF-2TM, will be a safe and effective~     herbal therapy for food allergy. We are enrolling those age 12-45 yrs old with allergies to~     peanut, tree nuts, sesame, fish, and/or shellfish.~   "
225818|NCT00602147|"~     RATIONALE: Studying blood or mouthwash samples in the laboratory from patients receiving~     melphalan for cancer may help doctors learn more about changes that occur in DNA, identify~     biomarkers related to cancer, and help predict how patients will respond to treatment.~      PURPOSE: This clinical trial is studying common genetic mutations related to mucositis in~     patients with multiple myeloma receiving high-dose melphalan.~   "
225819|NCT00602134|"~     The objective of this study was to assess the bioequivalence of a potential generic~     6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol®~     (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the~     fasted state.~   "
225820|NCT00602108|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     intraoperative radiation therapy after lumpectomy followed by external-beam radiation therapy~     may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects and how well radiation therapy~     works in treating women undergoing lumpectomy for stage I or stage IIA breast cancer.~   "
225821|NCT00602095|"~     This is a randomised study aimed at comparing the currently most frequently used~     prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective~     prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and~     randomised to one of the three methods. The main outcome measures were time to delivery, rate~     of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol~     would be superior to the other methods.~      The main finding of our trial was that the catheter showed the shortest induction to delivery~     interval. There were no differences between the two other prostaglandins. No differences in~     maternal and neonatal outcome was found~   "
225822|NCT00602082|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. It is not yet known whether giving capecitabine together with~     streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors.~      PURPOSE: This randomized phase II trial is studying giving capecitabine together with~     streptozocin to see how well it works compared with or without cisplatin in treating patients~     with unresectable or metastatic neuroendocrine tumors.~   "
225823|NCT00602069|"~     This study will evaluate the effectiveness of a brief cognitive behavioral treatment, Helping~     to Overcome PTSD through Empowerment, in treating abused women with post-traumatic stress~     disorder who are living in shelters.~   "
225824|NCT00602056|"~     The objective of the study was to assess the effect of 1) redesigned immunization card, 2)~     center-based education to mothers, and 3) redesigned card with center-based education to~     mothers, provided at DPT1, on DPT3 completion in a randomized controlled trial at rural~     Expanded Programme on Immunization (EPI) centers in Karachi, Pakistan.~   "
225825|NCT00602043|"~     This phase II trial is studying how well F-18 16 alpha-fluoroestradiol (FES) imaging works in~     predicting response to first-line hormone therapy in women with hormone receptor-positive~     metastatic breast cancer. Diagnostic procedures, such as FES imaging, may help predict how~     well patients will respond to hormone therapy and may help plan the best treatment.~   "
225826|NCT00602030|"~     The purpose of this study is to evaluate the safety and efficacy of SNDX-275 in combination~     with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer.~   "
225827|NCT00602017|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine~     Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fasting conditions using a~     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
225834|NCT00601926|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of kidney cancer by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in~     treating patients with unresectable or metastatic kidney cancer.~   "
225835|NCT00601913|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment with~     erlotinib.~      PURPOSE: This clinical trial is studying how well erlotinib works when given before surgery~     in treating patients with head and neck cancer that can be removed by surgery.~   "
225836|NCT00601900|"~     This randomized phase III trial studies tamoxifen citrate or letrozole together with~     bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in~     treating women with stage III or stage IV breast cancer. Estrogen can cause the growth of~     breast cancer cells. Hormone therapy using tamoxifen citrate* or letrozole may fight breast~     cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as~     bevacizumab, may help control breast cancer by stopping the growth of blood vessels to the~     tumor. It is not yet known whether giving hormone therapy is more effective with or without~     bevacizumab in treating advanced breast cancer.~   "
225837|NCT00601887|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam~     tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fed conditions using a~     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
225838|NCT00601874|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine~     Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fasting conditions using a~     single-dose, 2-treatment, 2-period, crossover design.~   "
225839|NCT00601861|"~     The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph~     nodes before and after the effect of recombinant interleukin-21 in patients with stage III~     melanoma~   "
225840|NCT00601848|"~     RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by~     tumor cells. The drug becomes active when it is exposed to light. When the drug is active,~     tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells~     that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy~     given during surgery works in treating patients with resectable non-small cell lung cancer~     that has spread to the pleura.~   "
225841|NCT00601835|"~     To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus~     and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to~     the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to~     subjects ≥ 60 years of age.~      To compare the post-vaccination geometric mean titers of antibody (GMTs) to Canadian~     manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the post-vaccination GMTs to~     the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to~     subjects ≥ 60 years of age.~   "
225842|NCT00601822|"~     This study will evaluate the effectiveness of adding cognitive remediation therapy to~     cognitive behavioral therapy for treating people with anorexia nervosa.~   "
225843|NCT00601809|"~     Adhesive small intestine obstruction (ASIO) is an important cause of hospital admission and a~     very common disease. Any improvement in this field will benefit many patients by reducing the~     operative rate. Patients with this disease are difficult to evaluate and to manage and their~     treatment is controversial. Emergency surgery is mandatory when strangulation is suspected or~     in the case of total obstruction. On the other hand, conservative non-operative treatment is~     indicated in the case of partial obstruction. The role of water-soluble contrast medium~     (Gastrografin®: GG) in ASIO is still debated with regard to the therapeutic value.~      The aim of our study was to determine the therapeutic role of Gastrografin in patients with~     small intestine obstruction without strangulation caused by adherences (ASIO).~   "
225844|NCT00601796|"~     The purpose of this study is to find out what effects (good and/or bad) a tumor vaccine used~     in combination with two drugs (ATRA and cytoxan) have on the patient and their cancer. We~     also want to find out if the vaccine and the drugs can boost the patient's immune system and~     how their immune system reacts, both before and after the vaccine treatment.~   "
225845|NCT00601770|"~     The objective is to investigate the virological (HCV-RNA) responses following biweekly~     immunization with IC41.~      Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.~   "
225846|NCT00601757|"~     This study will evaluate the effectiveness of an interpersonal therapy treatment called the~     Postpartum Prevention Program in preventing the development of postpartum depression in~     pregnant women who are financially disadvantaged.~   "
225847|NCT00601744|"~     The goal of this research study is to learn about the social and emotional factors that may~     affect the quality of life of patients with cancer of the eye or eye area who have had their~     facial appearance changed due to an orbital exenteration.~   "
225848|NCT00601731|"~     The purpose of this study is to evaluate how well the immuno response against meningococcal~     serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.~   "
225849|NCT00601718|"~     This phase I/II trial is studying the side effects and best dose of vorinostat when given~     together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well they work~     in treating patients with relapsed or refractory lymphoma or previously untreated T-cell~     non-Hodgkin lymphoma or mantle cell lymphoma. Vorinostat may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells~     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and~     etoposide, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving vorinostat together with rituximab and~     combination chemotherapy may kill more cancer cells~   "
225850|NCT00601705|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin, oxaliplatin, fluorouracil, and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving chemotherapy and radiation therapy~     after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy, surgery,~     and radiation therapy works in treating patients with locoregionally advanced cancer of the~     esophagus, gastroesophageal junction, or stomach.~   "
225851|NCT00601692|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Irinotecan and docetaxel may also make tumor cells more sensitive to radiation therapy.~     Giving combination chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when~     given together with irinotecan and radiation therapy with or without cisplatin in treating~     patients with locally advanced esophageal cancer.~   "
225852|NCT00601679|"~     This will be a multicentre Phase IV study in which patients with chronic HF who are managed~     and followed by HF/heart functions clinics will be followed over a period of two years.~      Clinic patients who are recruited into the study will have obligatory blood sampling for the~     surveillance measurement of NT-proBNP level every three months for a minimum of one year (4~     samples). One-half of the subjects in each clinic will be randomized to have these NT-proBNP~     values made known to the attending clinic physicians and nurses, the other half will have~     these values blinded. During the study, attending clinic physicians can order open-label~     NT-proBNP or BNP assays, if available in their institution, to assist the management of their~     patients if they feel it is clinically needed.~   "
225853|NCT00601666|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem~     Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions~     using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
225854|NCT00601653|"~     This study will evaluate the effectiveness of adding nutritional counseling to cognitive~     behavioral therapy in treating obese people with binge eating disorder.~   "
225855|NCT00601640|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged~     skin.~      PURPOSE: This randomized phase II trial is studying the side effects and how well~     eflornithine works compared with diclofenac, given alone or together, in treating patients~     with sun-damaged skin.~   "
225856|NCT00601627|"~     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     fluorouracil, capecitabine, and gemcitabine, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. External-beam~     radiation therapy uses high-energy x-rays to kill tumor cells. Panitumumab may also stop the~     growth of pancreatic cancer by blocking blood flow to the tumor and make tumor cells more~     sensitive to radiation therapy. Giving panitumumab together with chemotherapy and radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving panitumumab together with~     chemotherapy and external-beam radiation therapy works in treating patients with locally~     advanced pancreatic cancer that cannot be removed by surgery.~   "
225857|NCT00601614|"~     RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as temozolomide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving vandetanib together with~     temozolomide may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and~     temozolomide in treating patients with advanced solid tumors that cannot be removed by~     surgery.~   "
225858|NCT00601601|"~     RATIONALE: Studying the genes expressed in samples of tissue from patients with abnormal~     cells may help doctors identify biomarkers related to cancer.~      PURPOSE: This clinical trial is identifying biomarkers for early detection of cancer in women~     with cervical dysplasia or carcinoma in situ of the cervix.~   "
225859|NCT00601588|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline~     Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fed conditions using a~     single-dose, 2-treatment, 2-period, crossover design.~   "
225860|NCT00601575|"~     The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate~     450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg~     extended release tablet under fed conditions using a single-dose, randomized,~     three-treatment, three-period, six-sequence crossover design.~   "
225861|NCT00601562|"~     The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg~     tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fed conditions using a~     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
225862|NCT00601549|"~     This is a three-year research project. The major aims of this study are to:(1) compare the~     functional recovery and oncologic results in patients with advance rectal cancer treated by~     either traditional open or laparoscopic methods by randomized prospective clinical trials;(2)~     investigate the presence of tumor cells in the peripheral blood of patients undergoing either~     laparoscopic or open surgery; (3) searching for the clinicopathologic features of advanced~     rectal cancer after CCRT; (4) conduct the translational research regarding the difference of~     gene expression and its prognostic significance in advanced rectal cancer before and after~     chemoradiation therapy by micro-array analysis methods; (5) exploration of the potential stem~     cells of colorectal cancer using CD-133 cell surface marker.~   "
225939|NCT00600535|"~     The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations~     change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate) taken~     with and without food in patients with prostate cancer.~   "
225863|NCT00601536|"~     The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg~     extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release~     tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period,~     2-sequence crossover design.~   "
225864|NCT00601523|"~     The general aim of this study is to obtain long-term safety and tolerability data on~     pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have~     previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or~     248.636(NCT00558025) trial).~   "
225865|NCT00601510|"~     RATIONALE: Imatinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as capecitabine and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving imatinib together with combination chemotherapy may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib when given~     together with capecitabine and cisplatin in treating patients with unresectable or metastatic~     stomach cancer.~   "
225866|NCT00601497|"~     The purpose of this study is to find out whether electrical stimulation can reduce knee pain~     and increase function in people with osteoarthritis of the knee.~   "
225867|NCT00601484|"~     The purpose of this study is to determine whether PF-04383119 is effective in the treatment~     of pain associated with interstitial cystitis.~   "
225868|NCT00601471|"~     The overall aim of this project is to determine the effect of a tibiofibular joint~     manipulation on the neuromuscular response of the fibularis longus and soleus muscles in~     individuals with chronic ankle instability. Another aim of this study is to determine the~     long term effects of a tibiofibular joint manipulation on range of motion and self-reported~     function.~      We hypothesize that a manipulation applied at the distal tibiofibular joint will result in~     greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores~     compared to a tibiofibular joint manipulation applied at the proximal joint. We further~     hypothesize that both distal and proximal tibiofibular joint manipulations will result in~     greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores~     than no treatment at all.~   "
225869|NCT00601458|"~     We are interested in whether bunionectomy can be used as a model to study the treatment of~     acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS)~     medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if~     this model is useful to study other drugs for the treatment of acute pain. The other drugs~     being tested in this study are pregabalin and naproxen sodium. These drugs are approved for~     use by the Food and Drug Administration (FDA). This study is designed to test whether these~     two drugs are effective in treating pain after a bunionectomy.~   "
225870|NCT00601445|"~     The purpose of this study is to test the hypothesis that sleep homeostasis, also known as~     sleep pressure or sleep drive, is different in healthy older and younger individuals.~   "
225871|NCT00601432|"~     The main purpose of the study was to evaluate the effect of food on the single-dose~     pharmacokinetics of an oral solution of levofloxacin.~   "
225872|NCT00601419|"~     Post marketing drug use investigation of Genotropin for GHD-ADULTS.~   "
225873|NCT00601406|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~     It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This clinical trial is evaluating DNA mutations in predicting the effect of~     external-beam radiation therapy in patients with early breast cancer, localized prostate~     cancer, or gynecologic cancer.~   "
225874|NCT00601393|"~     This study will evaluate the effectiveness of an Internet-based cognitive behavioral therapy~     program in treating mothers with depression who have young children.~   "
225875|NCT00601367|"~     Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose~     regimens~   "
225876|NCT00601354|"~     This study will evaluate the effectiveness of adding guided self-help group therapy to a~     weight loss program in achieving weight loss and reducing binge eating in overweight binge~     eaters.~   "
225877|NCT00601341|"~     The purpose of this study is to gain a better understanding of the effects of lumbopelvic~     manual therapy on lower extremity biomechanics and arthrogenic muscle response. As a result~     of this study, we also hope that physical therapists, athletic trainers, and other physical~     medicine rehabilitation providers will gain a better understanding of lower extremity~     injuries and have the scientific evidence to provide patients with techniques which would~     allow for efficient return to activities of daily living without restrictions and possibly~     prevent future injuries and minimize risk of osteoarthritis.~      The objectives of this study are to:~        -  Determine the amount and duration of arthrogenic muscle response of quadriceps muscles~          following lumbopelvic joint manipulation.~        -  Determine the effects of lumbopelvic joint manipulation on temporospatial parameters of~          gait such cadence, step length, velocity and mean peak lower extremity joint moments.~        -  Determine if a correlation exists between patellofemoral joint pain and lumbopelvic~          joint dysfunction.~        -  Determine the amount of change in clinical outcome measure scores following lumbopelvic~          joint manipulation.~   "
225878|NCT00601328|"~     The objective of this study was to assess the bioequivalence of Roxane Laboratories'~     Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose,~     2-treatment, 2-period, crossover design, under fasting conditions~   "
225879|NCT00601315|"~     The objective of this study was the bioequivalence of a potential generic 250 mg~     clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin~     tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.~   "
225880|NCT00601302|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine~     Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a~     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.~   "
225881|NCT00601289|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients~     with invasive pituitary tumors.~   "
225882|NCT00601276|"~     Sexual abuse committed on children is a major public health problem because of its frequency~     and its severe consequences on the mental health of victims.~      Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide,~     with the hypothesis that leuprolide will be more effective.~   "
225883|NCT00601263|"~     The purpose of this study is to determine the safety of an anti-asthma herbal medicine~     intervention (ASHMI) in adult asthmatics and to see what effects ASHMI has on certain parts~     of the immune system.~   "
225884|NCT00601250|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to~     metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control~   "
225885|NCT00601237|"~     This study will develop and test the effectiveness of a cell phone-based text messaging~     program to encourage abstinence, monogamy, or condom use among black urban males in~     Philadelphia, Pennsylvania.~   "
225886|NCT00601224|"~     This study will determine the effectiveness of social cognition and interaction training, a~     manual-based group therapy program, in helping people with schizophrenia improve their social~     cognition and social functioning.~   "
225887|NCT00601211|"~     The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine~     Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fed conditions using a~     single-dose, 2-treatment, 2-period, crossover design.~   "
225888|NCT00601198|"~     The purpose of this study is to determine the effect of amifostine (ETHYOL) on decreasing the~     rate and severity of nerve dysfunction or neuropathy (numbness and tingling in hands and~     feet) associated with FOLFOX chemotherapy.~   "
225889|NCT00601185|"~     The purpose of this study is to evaluate a new instrument that shines light and takes digital~     pictures of skin. The goal is to develop a technique that may enable fast and accurate~     detection of skin disorders and cancers for future clinical diagnosis and surgical use.~   "
225890|NCT00601172|"~     This a Phase III trial designed to determine if IV casopitant plus dexamethasone and~     ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and~     ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based~     chemotherapy.~   "
225891|NCT00601159|"~     Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as~     first line therapy in patients with triple-negative MBC. 80 patients will be treated into~     this study.~   "
225892|NCT00601146|"~     This research study is being done because patients with a history of chest radiation~     treatment for Hodgkin's disease have been shown to be at increased risk for developing lung~     cancer a number of years out from treatment. The risk appears to be further increased among~     patients with a smoking history. Currently, the practice is to recommend annual low-dose~     chest CT scans in survivors of Hodgkin's disease who have received prior chest radiation~     treatment and who have at least a moderate smoking history. In this study, the CT scans will~     be read and interpreted by the study radiologist, and the results recorded in a consistent~     manner.~   "
225893|NCT00601133|"~     Objectives:~      Primary Objectives:~      To determine the change in functional tests of postural control of cancer patients who have~     completed acute inpatient rehabilitation or complete rehabilitation through mobile team from~     discharge at 21-60 days (+/- 3) after discharge.~      Secondary Objectives:~      To assess the correlations between the functional tests of postural control, the balance test~     and the amount of exercise per week.~   "
225894|NCT00601120|"~     The purpose of this study is to look at the effects of a procedure called radiofrequency~     ablation on kidney tumors from patients who are undergoing antiangiogenic treatment.~     Antiangiogenic treatment is a type of treatment that inhibits formation of new blood vessels~     that are required for tumor growth. Radiofrequency ablation (RF ablation) involves inserting~     a needle into tumor tissue and administering heat to the tumor tissue that is sufficient to~     kill the tumor cells.~   "
225895|NCT00601107|"~     The purpose of this study was to evaluate the safety and effectiveness of an investigational~     drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis,~     in comparison with a placebo (sugar pill). All study related care was provided including~     doctor visits, physical exams, laboratory tests and study medication. Total length of~     participation was 28 weeks.~   "
225896|NCT00601094|"~     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective~     immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.~   "
225897|NCT00601081|"~     This is a research study investigating if adding human milk fortifier to a preterm babies~     breast milk feedings affects the baby's immune system.~   "
225898|NCT00601068|"~     In cooperation with Merck & Co, Inc. we will identify and form a database of 35 patients who~     have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. We will~     study the triggers, associated medical conditions and medications, location of the lesion(s),~     and patient outcomes.~   "
225899|NCT00601055|"~     This study will evaluate the effectiveness of problem-solving therapy combined with treatment~     adherence procedures in treating older people with major depression and chronic obstructive~     pulmonary disease.~   "
225900|NCT00601042|"~     The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus)~     can help adult smokers to reduce and eventually completely quit smoking.~   "
225901|NCT00601029|"~     The purpose of this study is to:~        1. develop a normative database for serum creatine kinase (CK) responses to basic military~          training (BMT);~        2. determine the incidence of exertional rhabdomyolysis (ER) among a large cohort of~          recruits undergoing BMT;~        3. assess the impact of climate on the incidence of ER during BMT;~        4. determine the incidence of candidate genes that may be associated with an increased risk~          of ER.~   "
225918|NCT00600808|"~     Annualised height velocity after 12/24 months treatment and HV SDS height velocity after~     12/24 months treatment expressed as number of standard deviations difference from the mean~     population height velocity for the appropriate gender and chronological age.~   "
225919|NCT00600795|"~     Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with~     functional improvements after insertion of ventriculoperitoneal shunt for normal pressure~     hydrocephalus~   "
225902|NCT00601016|"~     Hemangiomas of infancy, the most common benign tumors of infancy, are congenital or early~     infancy lesions characterized by a rapid postnatal growth, with high expression of angiogenic~     stimulators for 9-18 months, followed by slow regression for 5-9 years. Current therapies for~     the hemangiomas are usually restricted to more severe forms due to the risks of adverse~     effects, inconvenience and cost. Nevertheless, a substantial amount of the psychological~     discomfort and morbidity can be caused by untreated hemangiomas, especially those in the~     face.~      Recently, Imiquimod 5% cream has emerged as a safe an effective drug for several skin~     conditions that benefit from modulation of the activity of the immune system, such as common~     warts and various forms of the skin pre-cancerous and cancerous lesions. Small case reports~     series have suggest that it could also be useful in hemangiomas, possibly through the~     inhibition of the angiogenesis by local IFN production.This is a small, open label study of~     16 patients to document the efficacy of the Imiquimod 5% cream in the treatment of hemangioma~     of infancy (primary outcome). IFN and plasma drug levels, as well as clinical examinations~     and blood studies, will be carried out to evaluate safety of the treatment (secondary~     outcome). bFGF and VEGF will be measured in blood and urine in order to study the diagnostic~     and predictive value of these pro-angiogenic factors in the response of hemangiomas to the~     treatment with Imiquimod (secondary outcome).~      The study is a phase II clinical trial of a once a day application of Imiquimod 5% cream, 3~     to 7 times per week for a maximum of four months. The study held at the Dermatology Clinic of~     Sainte-Justine Hospital, and was completed within a 20 months timeframe after IRB approval.~   "
225903|NCT00601003|"~     The purpose of this study is to determine whether nifurtimox in combination with~     cyclophosphamide and topotecan are effective in the treatment of relapsed or refractory~     neuroblastoma and medulloblastoma.~   "
225904|NCT00600990|"~     The purpose of this study is to determine the effectiveness of this medication in preventing~     nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).~   "
225905|NCT00600977|"~     Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of~     doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of~     Dox li-PEG, bolus infusion of vincristine and dexamethasone~   "
225906|NCT00600964|"~     This protocol is being run to determine the best phase II dose and schedule of obatoclax in~     patients with previously untreated CLL.~   "
225907|NCT00600951|"~     The objective of this long-term study is to prospectively compare the incidence of NSF in two~     cohorts (Cohort 1 - patients with moderate chronic kidney disease eGFR 30 to 59 and Cohort 2~     - patients with severe chronic kidney disease or kidney failure eGFR <30).~   "
225908|NCT00600938|"~     This is a clinical research study in patients who have iron overload in the heart due to~     chronic blood transfusions.~      The study will have 2 treatment groups and will compare the safety and efficacy of chelation~     therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine~     (DFO). The study is aimed at finding out which of the two medicines is the best for treating~     iron overload in the heart.~      Patients will be treated for 12 months (core study phase). Patients who complete the core~     study phase will be offered to continue their study treatment in a 12 months extension phase.~     During the core and extension, the effects of treatment on iron overload in the heart and the~     liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.~   "
225909|NCT00600925|"~     The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and~     effective for preventing surgical wound infections in patients undergoing colorectal surgery.~   "
225910|NCT00600912|"~     Lipid emulsions are an essential part of parenteral nutrition, both as a part of energy~     supply, and as a source of essential fatty acids. It has been shown that the fatty acid~     composition of cell membranes is influenced by the fatty acid profile of dietary lipids, and~     may therefore be responsible for modulation of immune response. The aim of this study was to~     assess the effects of a new lipid emulsion based ob soybean oil, medium-chain triglycerides,~     olive oil and fish oil compared with a lipid emulsion based on olive and soybean oil on the~     inflammatory response and hepatic function in postoperative intensive care unit (ICU)~     patients.~   "
225911|NCT00600899|"~     The purpose of this double blind, randomized study is to evaluate which rate and duration of~     infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for~     analgesia after ambulatory foot surgery.~   "
225912|NCT00600886|"~     The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.~      The objective of this study was to compare the proportion of patients with a reduction of~     mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and~     sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12~     months.~      Following one year of treatment patients could proceed into the study extension.~      Patients who did not respond to the treatment they were randomized to (based on month 12~     assessment results) were switched to the other treatment arm at month 13.~   "
225913|NCT00600873|"~     R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and~     spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative~     stress.~   "
225914|NCT00600860|"~     Study Objectives:~      To collect and describe demographics, disease-management, and treatment outcomes of~     Myelodysplastic Syndromes (MDS) patients who are newly diagnosed and classified according to~     the WHO criteria.~      To perform observational studies concerning relevant scientific research questions in MDS~     using clinical data and biological samples, and to present relevant research outcomes in the~     fields of diagnosis and prognostication, health related quality of life issues, health~     economics, and risk stratification for newly developed classes of drugs.~      To disseminate results of the studies to all stakeholders involved.~   "
225915|NCT00600847|"~     The aim of this study is to compare cold urticaria lesions by thermography, volumetry and~     digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg~     desloratadine. Hypothesis: The updosing of desloratadine (20 mg)is more effective in the~     treatment of ACU symptoms as compared to standard doses (5 mg desloratadine) and placebo.~   "
225916|NCT00600834|"~     The objective of this long term study is to prospectively compare the incidence of NSF in two~     cohorts (Cohort 1- patients with moderate chronic kidney disease eGFR 30-59 and Cohort 2-~     patients with severe chronic kidney disease or kidney failure eGFR <30).~   "
225922|NCT00600756|"~     The trial is designed to assess the long term subjective well-being in schizophrenic~     outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible~     dose in a naturalistic setting over a period of one year. Secondary outcome measures have~     been selected for helping in the differentiation of the compared atypical antipsychotics. The~     primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to~     risperidone assessed at month 6 in terms of responder rate using the self-report instrument~     SWN-K~   "
225923|NCT00600743|"~     The ultimate aim of this study is to test the hypothesis that the oral cholecystokinin (CCK)~     agonist GSKI181771X will reduce the size of a binge meal among individuals with Bulimia~     Nervosa. The study will be conducted in phases. First, an effective dose for reducing food~     intake, when normal subjects eat normally will be attained. Next, it will be determined~     whether intake at this dose is reduced in control subjects instructed to eat to capacity. If~     the dose is still effective compared to placebo, the same dose will be tested in patients~     with bulimia nervosa.~   "
225924|NCT00600730|"~     The studies proposed in this application seek to use non-invasive techniques to examine the~     impact of repeated hypoglycemia on the brain.~   "
225925|NCT00600717|"~     The objective of this study is to use high-frequency brain signals (HFBS) to localize~     functional brain areas and to characterize HFBS epilepsy, migraine and other brain disorders.~     We hope to build the world's first high-frequency MEG/MEG/ECoG/SEEG database for the~     developing brain. HFBS include high-frequency oscillations (HFOs), ripples, fast ripples or~     high-gamma activation in the brain.~      To reach the goals, we have developed several new MEG methods: (1) accumulated spectrogram;~     (2) accumulated source imaging; and (3)frequency encoded source imaging.~   "
225926|NCT00600704|"~     The investigators' hypothesis is that restriction of circulating fluids in comparison to a~     liberal fluid administration policy would lead to a reduction of allogenic red blood cells~     exposure in patients undergoing cardiopulmonary bypass (CPB) for primary coronary artery~     bypass graft supported by reinfusion of washed shed blood from thoracic cavities.~   "
225927|NCT00600691|"~     The purpose of our study is primarily to evaluate the effects of 5mg finasteride on hematuria~     and hematospermia commonly associated with prostate biopsies. We hypothesize that 5mg of~     finasteride daily for two weeks preceding TRUS prostate biopsy and one week following will~     reduce hematuria and hematospermia commonly seen as complications following prostate biopsy.~     We also hypothesize that reducing complications will decrease concern among subjects and make~     for a more tolerable overall procedure than compared with subjects treated with placebo.~   "
225928|NCT00600678|"~     Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by~     using the paracetamol absorption method in healthy volunteers.~   "
225929|NCT00600665|"~     Sickle cell disease (SCD) is a blood disorder that is characterized by intense, painful~     episodes known as sickle cell crises. This study will evaluate the effectiveness of~     PAINRelieveIt, a three-part computer-based pain management tool, in treating adults with SCD.~   "
225930|NCT00600652|"~     Monitoring the GR with a GR-MoAb and FITC-Dex probes by FCM would be useful and convenient in~     determination GR before the steroid treatment in clinical, especially in steroid resistant~     states, in order to design more efficient clinical treatment protocols.~   "
225931|NCT00600639|"~     The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the~     studies performed in ICUs and in another facilities the mean age of the patients is usually~     less than 70 years.~      A multicentric, randomized-controlled trial conduced in a group of ELDERLY patients with~     the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment~     (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.~   "
225932|NCT00600626|"~     This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus~     treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood~     glucose control in type 2 diabetes.~   "
225933|NCT00600613|"~     The purpose of this study is to test a new and possibly more accurate method of positioning~     patients with liver tumors in preparation for radiation treatment.~      The positioning of patients with liver cancer is important because the tumor moves a bit when~     you breathe and makes it hard to determine the right position of the tumor at the time of~     treatment. Also, depending upon what is in your stomach at the time of treatment, it may~     change the shape of the liver and make it difficult to plan the radiation treatment. As part~     of this study, we will take a new type of image of your liver in addition to the standard~     portal images. This new type of image is called a cone-beam image. It shows a much more~     detailed picture of the liver tumors than the standard portal images. Normally, marker seeds~     need to be placed near the liver metastasis for radiation treatment. If the results of this~     study show that the tumor can be positioned as accurately with the new images as with the old~     images, then future patients with liver tumors would not have to have marker seeds placed~     into their liver. The use of cone beam imaging for the setup of patients with liver tumors is~     new.~   "
225934|NCT00600600|"~     To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients~     with rapidly growing mycobacterial disease (especially M.abscessus).~   "
225935|NCT00600587|"~     The purpose of this study is to evaluate the value of induction Erlotinib therapy before~     thoracotomy or radiotherapy in ⅢA-N2 (confirmed by mediastinoscopy or PET) non-small cell~     lung cancer (NSCLC) selected by epidermal growth factor receptor (EGFR) gene analysis and~     initial to explore a new treatment strategy for ⅢA-N2 NSCLC.~   "
225936|NCT00600574|"~     The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation~     of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.~   "
225937|NCT00600561|"~     The purpose of this study is to investigate whether Mindfulness-Based Stress Reduction (MBSR)~     vs a one-day MBSR seminar improves immune (CD4+ T lymphocytes) and virological (HIV viral~     load) status in HIV-1 infected adults. The secondary goal of the study is to determine if~     MBSR vs a one-day MBSR seminar improves self-reported HIV-related quality of life.~   "
225938|NCT00600548|"~     The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine~     in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous~     standard treatment (meglumine antimoniate - Glucantime®).~   "
225993|NCT00599820|"~     Intravitreal Bevacizumab is an effective treatment for choroidal neovascularization secondary~     to Angioid Streaks~   "
225940|NCT00600522|"~     Major hepatectomies have not negligible morbidity and mortality. However, when tumors invade~     middle hepatic vein (MHV) at caval confluence major surgery is usually recommended.~     Ultrasound-guided hepatectomy might allow conservative approaches. We prospectively check its~     feasibility in a series of patients carriers of tumors invading the MHV at the caval~     confluence.~   "
225941|NCT00600509|"~     Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and~     safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with~     partial onset seizures.~   "
225942|NCT00600496|"~     This study is being conducted to determine if a combination of AZD6244 given orally twice a~     day with standard doses of selected chemotherapies will be safe and tolerable for cancer~     patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination~     with selected chemotherapies will be evaluated. The study will also investigate how AZD6244~     in combination with standard chemotherapies are absorbed, distributed and excreted by the~     body as well as the length of time that the drugs remain in the body. Initial and periodic~     assessments will establish patient response to the combination therapies.~   "
225943|NCT00600483|"~     The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and~     effective in preventing sternal wound infections in patients undergoing cardiac surgery who~     are at a greater risk of developing sternal wound infections.~   "
225944|NCT00600470|"~     This study will evaluate the effectiveness of a doctor-office collaborative care approach in~     treating children with disruptive behavior problems in the pediatric primary care setting.~   "
225945|NCT00600457|"~     The purpose of this study is to determine whether the combination of modified polyurethane~     film and secondary absorbent dressing for skin graft donor sites avoids the regular~     uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.~   "
225946|NCT00600444|"~     The purpose of this trial is to investigate if the success rate of punction the vena~     subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae~     sectio (80% in retro and prospective studies) for implantation of a totally implantable~     access ports.~   "
225947|NCT00600431|"~     Changes in nevus count in 16 children (8m, 8f) aged between 2 and 17 years (median:8 years)~     suffering from different malignancies were examined every three months during a one-year~     period after starting chemotherapy. An age and sex matched control group underwent the same~     skin examinations.At the start of our study, the range of number of nevi in the chemotherapy~     group was 0-133, in the control group 2-199.~   "
225948|NCT00600418|"~     The project is aimed at identifying children who are suffering from posttraumatic distress~     and increasing capacity to provide treatment for them and for their caretakers. The project~     will be implemented in 3 cities in Israel, Haifa, Kiryat Shmona and Sderot, exposed to~     terrorism and the effects of war~   "
225949|NCT00600405|"~     The purpose of this study is to determine the efficacy of the α-adrenergic antagonist~     tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic~     secondary to lower ureteral calculus. We hypothesize that there will be no difference in~     outcomes for subjects treated with and without tamsulosin.~   "
225950|NCT00600392|"~     Genes expressing inflammatory cytokines (TNF- alpha, IL1 etc) and genes involved in apoptosis~     (Caspase 3, Bax, Bcl-2, Fas) are dysregulated in the skeletal muscles of the patients who~     have muscle wasting and decreased exercise capacity with CHF.~      Patients who show benefit from CRT may also show reversal of the inflammatory/apoptotic~     cascade that accompanies CHF and these patients may be the ones who benefit the most from CRT~   "
225951|NCT00600379|"~     The purpose of this study is to examine the feasibility and efficacy of a virtual reality~     program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.~   "
225952|NCT00600366|"~     This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of~     biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing~     on secondary oral hypoglycaemic agent (OHA).~   "
225953|NCT00600353|"~     To assess emetic responses to multi-day doses of Palonosetron and Aprepitant and low dose~     dexamethasone +/- Prochlorperazine among patients with multiple myeloma and lymphoma~     undergoing autologous HSCT utilizing the Multinational Association for Supportive Care in~     Cancer (MASCC) Antiemesis Tool (MAT).~   "
225954|NCT00600340|"~     First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast~     cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.~   "
225955|NCT00600327|"~     The primary objective of this study is to demonstrate the safety of the NexStent for~     treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire~     distal embolic protection device. The rates will be compared to an Objective Performance~     Criterion (OPC) derived from historic data from high-risk patients undergoing surgical~     intervention with Carotid endarterectomy. Patients included in this study are those at higher~     risk for complications associated with CEA.~   "
225956|NCT00600314|"~     This study aims to show that the MedGem indirect calorimetry measurement device will be~     feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD~     will have elevated REE that is not adequately predicted by standard equations.~   "
225957|NCT00600301|"~     Diabetic macular edema is the most common cause of visual loss among patients with diabetic~     retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of~     diabetic macular edema. Previous report showed a limited improvement in visual acuity and~     macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal~     injection has been proven be effective in the treatment of diabetic macular edema, in recent~     publications. The purpose of this study is to evaluate whether vitrectomy with and without~     intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and~     macular thickness in patients with diabetic macular edema.~   "
225958|NCT00600288|"~     The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium~     Ophthalmic Solution, 2% in dry eye subjects.~   "
226191|NCT00597142|"~     The purpose of this study is to demonstrate superior 9-month binary restenosis rate of the~     Express™ Renal Premounted Stent System as compared to an Objective Performance Criterion~     representative of PTRA, for atherosclerotic lesions in the aortorenal ostium.~   "
226192|NCT00597129|"~     Safety study to determine highest dose of 90Y-hPAM4 can be safety administered~   "
225959|NCT00600275|"~     This is a phase I/II clinical research study with BGT226, an inhibitor of~     phosphatidylinositol 3'-kinase (PI3K). The study consists of a Phase I dose escalation part~     followed by a safety expansion part and a Phase II expansion part.~      Once the MTD has been defined, the safety expansion and efficacy expansion parts of the trial~     will be opened for enrollment.~      Phase I safety expansion part will enroll advanced solid tumors. Phase II expansion part will~     enroll advanced breast cancer. An effort will be made to enrich the trial population with~     Cowden Syndrome patients with advanced solid malignancies.~   "
225960|NCT00600262|"~     Background: to evaluate the 3-month efficacy of a single dose of intravitreal bevacizumab on~     the progression of severe non proliferative diabetic retinopathy, proliferative diabetic~     retinopathy and active photocoagulated diabetic proliferative by evaluation of ischemic areas~     and regression of retinal and disc neovasculrization.~      Methods: 40 patients were enrolled in a prospective, interventional study. Patients were~     treated with intravitreal bevacizumab 0.1ml (0.25mg). We evaluated visual acuity,~     neovascularization leakage points, capillary closure ischemic areas and macular edema by~     clinical examination and fluorescein angiography. A clinical examination was performed at~     baseline and days 1,14 and 30. Active leakage points were measured by fluorescein angiography~     at 30 days.~   "
225961|NCT00600249|"~     The purpose of this study is to assess the pathological response rate in operable breast~     cancer patients treated by neoadjuvant combination Taxotere-Erbitux.~   "
225962|NCT00600236|"~     One of the first causes of irreversible blindness in mexican population is diabetic~     retinopathy which is clearly diferent between patients the time of evolution and development~     of retinopathy and complications. The aim of this study is to explore the inmunogenetic~     profile and the influence of HLA in this variations of the sickness to predict the severity~     of diabetic complications.~   "
225963|NCT00600223|"~     The purpose of this study is to evaluate the nature and quality of speech after removal of~     the voice box and all or part of the swallowing tube.~      The study is evaluating which type of surgery provides patients with the best speech and~     voice.~      These data will be used to help surgeons to design better ways to restore voice function~     after removal of the voice box. Information about disease, its treatment, quality of life,~     and physical and vocal function will be collected. An audio recording of vocal tasks will~     also be done. All of this information will be analyzed and the two different subject groups~     will be compared to see if there are differences.~   "
225964|NCT00600210|"~     This trial is designed to study the safety and efficacy of the combination of carboplatin,~     bevacizumab, and pelvic radiation therapy.~      Rationale for substituting cisplatin with carboplatin:~      Five landmark trials in cervical cancer prompted the National Cancer Institute in February of~     1999 to issue a clinical announcement stating that strong consideration should be given to~     adding concurrent chemotherapy in the treatment of invasive cervical cancer. The~     chemotherapeutic agent which was a common denominator to all 5 trials was cisplatin, and ever~     since it has become part of the standard of care for the treatment of stage IIB, III, and IVA~     cervical cancers. In addition, chemoradiotherapy with cisplatin is also considered one of the~     standard treatment options for IB2 and IIA tumors greater than 4 cm in diameter.~      The most recent Gynecologic Oncology Group protocols for cervical cancer have used cisplatin~     and radiation therapy as in two of the five landmark trials. However, the benefit in survival~     given by cisplatin has not been without toxicity. In summary, in the trial by Keys 35% of~     patients receiving cisplatin and radiotherapy experienced moderate or severe toxicities. In~     the one by Rose, only 49 % completed the intended 6 cycles of chemotherapy.~      Based on the toxicity profile of cisplatin, Higgins performed a phase II study of concurrent~     carboplatin with pelvic radiation therapy in the primary treatment of cervix cancer. He~     demonstrated the ability to administer carboplatin with concurrent radiation therapy with~     significantly less toxicity and with 94 % of the planned treatments delivered.~      A comprehensive analysis of the literature from 1998 which compared the efficacy of~     carboplatin versus cisplatin in solid tumors concluded that for ovarian cancer and lung~     cancer the effectiveness of carboplatin was comparable to cisplatin, while for germ cell~     tumors, bladder cancer, and head and neck cancer cisplatin appeared superior. There was no~     mention of cervical cancer in this review, since at present there is no phase III trial~     comparing carboplatin versus cisplatin in cervix cancer.~      Rationale for bevacizumab:~      Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits~     the biologic activity of vascular endothelial growth factor (VEGF) which stimulates tumor and~     tumor blood vessel growth. Targeting VEGF with bevacizumab could potentially be of benefit in~     cervical cancer patients by starving the tumor's blood supply and potentially enhancing the~     effect of radiotherapy and carboplatin chemotherapy.~   "
225965|NCT00600197|"~     The purpose of this study is to examine whether the biopsychosocial educational program could~     improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.~   "
225966|NCT00600184|"~     The AMES device a investigational device which cyclically rotates the ankle while muscle~     vibrators stimulate sensory receptors in the muscles opposite to the joint being rotated. In~     effect, the device provides assisted movement of a joint and enhanced sensation of that~     movement. The purpose of this study is to determine whether stroke survivors who remain~     unable to move normally more than one year after their stroke will be able to walk and move~     their affected leg significantly better after treatment with a new robotic therapy, the AMES~     device.~   "
225967|NCT00600171|"~     This study is designed to determine if the investigational drug is effective and safe in~     individuals with asthma~   "
225968|NCT00600158|"~     Epidural local anesthetics are the gold standard for shortening duration of bowel dysfunction~     after bowel surgery. Previous studies suggest that their effect may be in part a result of~     actions of the local anesthetic outside the epidural space. If local anesthetics could be~     administered intravenously instead, this might be a safer, easier and less expensive~     approach. Therefore, this trial will compare the effect on bowel function recovery of~     intravenous local anesthetics with those administered epidurally.~   "
225969|NCT00600145|"~     The primary purpose of this study is to determine if Mirtazapine will produce a decrease in~     interest in the drug, a decrease in mood elevation, and/or a decrease in reward when given~     before methamphetamine compared to placebo.~      Participants will be screened with a psychiatric interview, medical history and physical,~     laboratory tests, drug of abuse screen and, if female, a urine pregnancy test. They will be~     provided written informed consent. They will be studied in a within-subjects examination of~     the subjective mood responses of mirtazapine and methamphetamine. Interactions between~     methamphetamine and mirtazapine will be assessed by pharmacokinetic studies. Each participant~     will be introduced to rating scales and cognitive tasks described below. Participants will~     remain in the research unit for 5 hours on each day that they receive study medication or~     placebo. They will spend five days in total on the research unit, one day separated by at~     least one day; then in two day blocks separated by at least one day from another two day~     block. A venous catheter will be placed for blood draws. Blood pressures and heart rates will~     be recorded and assessed. Participants will be randomized and double blinded to receive~     either placebo or mirtazapine orally two hours prior to the administration of randomized and~     double blinded methamphetamine or placebo in order to have the peak effects of the drugs~     overlap. VAS-mood, ARCI, GRS, POMS and POMS-E, neurocognitive tasks Trails A and B and Symbol~     digits modalities test will be administered prior to the mirtazapine or placebo dose, and~     repeated after the administration of methamphetamine or placebo. After the administration of~     methamphetamine or placebo, vital signs will be assessed every 15 minutes and the measures~     will be repeated until 120 minutes have passed from the initial dose of methamphetamine or~     placebo. Blood will be drawn at one, three and four hour marks for pharmacokinetic testing.~     This will be repeated on each testing day.~   "
226216|NCT00596804|"~     This study is being done to assess the safety and tolerance of different doses of humanized~     hA20 in patients with NHL.~   "
225970|NCT00600119|"~     Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized,~     dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of~     NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical~     manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to~     evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.~   "
225971|NCT00600106|"~     The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy~     with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of~     chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study~     as a core lab coordinating center, the investigators will be performing P31 MRS core lab~     analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core~     lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery~     reactivity test core lab analyses; full study data analyses for manuscript preparation and~     the writing and submission and publication of manuscript.~      The main trial duration: December 1999 - May 2003.~      The ancillary data analysis project duration: April 2006 - March 2010.~   "
225972|NCT00600093|"~     The purpose of this study is to determine whether administrating of Amantadine (a dopamine~     agonist) to patients suffering from Parkinson disease during the perioperative period is~     safe, and to asses potential benefits of this treatment.~   "
225973|NCT00600080|"~     This study seeks to evaluate the clinical performance of a recently improved daily disposable~     contact lens to an established daily disposable contact lens that contains a wetting agent.~   "
225974|NCT00600067|"~     The purpose of the study is to determine the long-term safety and efficacy of VI-0521~     (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2~     diabetic adults. Continuation of initial 6 month trial.~   "
225975|NCT00600054|"~     This is a phase 2, single-arm, multi-center study, with a safety review component, designed~     to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with~     recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their~     disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic~     pontine glioma that is measurable in at least two dimensions. Patients are eligible without~     histologic confirmation. Treatment regimen will consist of two phases-induction and~     consolidation.~   "
225976|NCT00600041|"~     Recently, negative inotropy of pantoprazole has been shown in isolated human myocardium. This~     study was designed to test the clinical relevance of this finding in healthy volunteers by~     measuring left ventricular function during infusion of a common intravenous high dose regimen~     of pantoprazole.~   "
225977|NCT00600028|"~     Idiopathic Pulmonary Fibrosis (IPF) is a rapidly progressive lung disorder that is often~     associated with a chronic, intractable cough. The etiology of the cough associated with IPF~     is unclear but it is often so severe that it adversely effects the patient's quality of life.~     We propose that thalidomide specifically suppresses the cough associated with idiopathic~     pulmonary fibrosis via its anti-inflammatory properties, by suppressing the excessive~     functional up-regulation of sensory fibers with in the respiratory tract of patients with~     IPF.~      This study is a Phase III, double blinded, randomized, placebo controlled, crossover trial~     testing the efficacy of thalidomide in suppressing the chronic cough of IPF. The primary~     objective of this study is to determine the efficacy of thalidomide administered daily for 12~     weeks to suppress the chronic cough in patients with idiopathic pulmonary fibrosis as~     measured by cough specific questionnaires, scales and improved quality of life.~   "
225978|NCT00600015|"~     This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in~     patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens.~     Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice~     daily), or erlotinib (150 mg/day) and a placebo.~   "
225979|NCT00600002|"~     The application of immunotherapeutic strategies that target the most potent antigen~     presenting cell, the dendritic cell (DC), are likely to substantially increase the magnitude~     of the anti-tumor immune response. Although there are issues of activation state and antigen~     load, mechanisms to increase the number of DCs available to the immune system are among the~     first steps in development of affective DC based immunotherapeutic strategies. The Central~     Hypothesis of our study is: Administration of Granulocyte Macrophage Colony Stimulating~     Factor (GM-CSF) to patients with pancreatic adenocarcinoma will result in enhance recruitment~     of DCs to the sentinel lymph node, into the peripheral blood, and/or tumor site. We propose~     performing a phase I, dose escalation, clinical trial of systemic and intra-tumoral GM-CSF~     administration for the treatment of pancreatic adenocarcinoma. This trial will be designed to~     assess toxicity and immunologic effects, principally dendritic cell recruitment. Patients~     with resectable pancreatic adenocarcinoma by clinical staging criteria will be eligible for~     enrollment.~      The trial we propose is a phase I clinical trial of the addition of GM-CSF as a biological~     adjuvant to standard care for patients with potentially resectable pancreatic adenocarcinoma.~   "
225980|NCT00599989|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.~      PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy~     and how well it works in treating women undergoing breast conservation therapy for~     early-stage breast cancer.~   "
225981|NCT00599976|"~     For patients with atrial fibrillation and heart failure, current treatment can include AV~     nodal ablation with biventricular pacing. Pulmonary vein isolation (PVI) is a new procedure~     for this patient population which attempts to restore sinus rhythm. This trial is a~     randomized controlled trial of AVN ablation with biventricular pacing versus PVI for atrial~     fibrillation patients with congestive heart failure.~   "
226006|NCT00599651|"~     In this protocol we will conduct a randomized controlled trial where babies with respiratory~     distress syndrome (RDS) who have not yet reached criteria for intubation, will be randomized~     to receive surfactant by LMA or to continue receiving standard therapy of nasal CPAP and~     supplemental oxygen. All babies will be given surfactant by endotracheal tube if they reach~     failure criteria, which is the standard criterion for surfactant administration (i.e.,~     FiO2= 65% while receiving nasal CPAP).~      The objective of this RCT is to determine if surfactant can be successfully administered by~     LMA, thus perhaps avoiding the need for endotracheal intubation. The hypothesis is that fewer~     babies in the LMA group would reach failure criteria.~   "
225982|NCT00599963|"~     Immunoglobulin A (IgA) nephropathy is the common type of primary glomerulonephritis in the~     world. A wealth of literature suggests that vitamin D and its analogs have profound effects~     on immune system function and glomerular mesangial cell proliferation. However, calcitriol,~     the standard form of vitamin D, carries a substantial risk of hypercalcemia. Recently,~     paricalcitol (19-nor-1,25-dihydroxyvitamin D2) was approved for the treatment of secondary~     hyperparathyroidism in chronic renal failure, and the incidence of hypercalcemia is much~     lower than calcitriol. Therefore, the investigators plan to conduct a randomized cross-over~     study to evaluate the efficacy of paricalcitol in the treatment of IgA nephropathy. Thirty~     patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to~     paricalcitol for 12 weeks or no treatment, followed by cross over to the other arm after a~     washout period. Proteinuria, renal function, serum and urinary inflammatory markers will be~     monitored. This study will explore the potential anti-proteinuric and anti-inflammatory~     effects of paricalcitol in the treatment of IgA nephropathy, which has no specific treatment~     at present.~   "
225983|NCT00599950|"~     To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal~     after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem,~     LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).~   "
225984|NCT00599937|"~     Objectives of the trial were to assess the optimal timing of chemotherapy with or after ATRA~     and the role of maintenance therapy.~   "
225985|NCT00599924|"~     This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate,~     SUTENT) in combination with FOLFOX [Leucovorin + Fluorouracil (5-FU) + Oxaliplatin]. Three~     different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2,~     Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors,~     including colorectal cancer.~   "
225986|NCT00599911|"~     The primary purpose of this study is to assess the efficacy in treating patients with Major~     Depressive Disorder of one or more doses of Lu AA24530 relative to placebo~   "
225987|NCT00599898|"~     The purpose of this study is to investigate the efficacy and the safety of nifedipine~     compared to atosiban for treating preterm labor.~   "
225988|NCT00599885|"~     People with diabetes mellitus are more prone to coronary heart disease, stroke, and~     peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk~     factor for the progression of coronary artery disease. Several studies have been reported~     that diabetes increased the risk of cardiovascular mortality in both men and women. With the~     introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later~     months have reduced dramatically in several studies. However, even with DESs, diabetic~     patients showed increased rates of restenosis and late loss index compared with nondiabetic~     patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous~     coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes~     after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been~     demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era~     of DESs, no study has compared the effects of telmisartan and valsartan on neointima volume~     with intravascular ultrasound (IVUS) at 8 months after zotarolimus-eluting stent implantation~     in hypertensive type 2 diabetic patients. Telmisartan, which is well-known for its selective~     peroxisome proliferator-activated receptor (PPAR)-γ activity with its anti-inflammatory and~     antiproliferative properties, could be an appropriate therapeutic option for treating~     hypertensive diabetic patients with significant coronary artery diseases requiring stent~     implantation. In contrast, valsartan is an angiotensin receptor blocker with negligible~     PPAR-γ activity. Increasing interest remains in the identification of systemic~     pharmacological therapies to prevent coronary restenosis especially in diabetic patients.~   "
225989|NCT00599872|"~     The purpose of this study is to determine an effective dose range for the administration of~     ragweed allergenic extract via the sublingual route of administration~   "
225990|NCT00599859|"~     The genetics of lactase divides the population into 2 phenotypes: Those who can(LP) and those~     who cannot(LNP)digest lactose. This division may help modify disease risks according to~     geographic population distribution. At least some of the putative mechanism of risk~     modification may relate to an effect of undigested lactose on lower intestinal bacteria. The~     effect may provide for support of beneficial microbes. The amount of lactose reaching the~     colon is made easier in LNP than LP subjects who have to consume larger amounts to have~     meaningful spillover into the lower bowel.The current study examines whether there are~     quantifiable qualitative fecal bacterial differences to a standard intake of lactose(milk~     sugar)between these 2 different phenotypic populations. Finding of differences would lend~     support to the notion that for some diseases LP and LNP subjects face different risks even in~     an area of uniform disease risk if they consume lactose (found in dairy foods).~      The primary end point is comparison of 4 groups of specific bacteria between LP and LNP~     participants before and after 2 weeks of lactose(in powder form mixed in water) consumption.~     Classification is based on genetic analysis and secondarily on breath hydrogen results.~     Results are compared within groups.~      The secondary outcome is comparison of 4 groups of bacteria between LP and LNP subjects~     against each group of stool samples obtained on the first visit. Results are obtained between~     groups.~      Additional information and other secondary outcomes are to evaluate any relationship between~     diet intake and the 4 groups of bacteria on the first visit~      Another outcome will be to compare within groups any effect of lactose consumption on insulin~     and glucose levels within the 2 groups.~   "
225991|NCT00599846|"~     The objective of the 18-month trial is to evaluate the natural history of geographic atrophy~     by assessing the rate of progression of the geographic atrophic lesion over time.~   "
225992|NCT00599833|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Radiation therapy uses high energy~     x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of~     radiation directly to the tumor may kill more tumor cells and cause less damage to normal~     tissue. Giving cetuximab together with 3-dimensional conformal radiation therapy may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation~     therapy works in treating patients with locally advanced pancreatic cancer that cannot be~     removed by surgery.~   "
225994|NCT00599807|"~     This is a 2-year double-blind randomized controlled trial in 287 community-dwelling~     individuals age 60 years or older undergoing uni-lateral total knee replacement due to severe~     OA of the knee.We compare an oral dose of 2000 IU vitamin D3 per day to 800 IU. The primary~     endpoints are pain and disability related to rehabilitation of the operated knee,and related~     to the expected high prevalence of OA in the contra-lateral knee. Secondary endpoints are~     change in 25(OH)D levels, muscle strength, balance, lower extremity function, the rate of~     falls, bone density and bone quality, bone metabolism, general pain, fall-related fractures,~     body composition, blood-pressure, major cardiovascular events, blood glucose-insulin levels,~     executive cognitive function, rate of upper respiratory tract infections / all infections,~     tooth loss, dental health, health care utilization, number and size of facial skin keratosis,~     and radiographic progression of the non-operated knee. Pain and disability will be assessed~     by the pain and function subscales of the Western Ontario- McMaster Universities~     Osteoarthritis Index (WOMAC). Randomization will be stratified by WOMAC function prior to~     surgery, radiological evidence for OA in the contra-lateral knee, and hospital. Clinical~     visits will take place at baseline (6-8 weeks after TKR), at 6, 12, 18 and 24 months of~     treatment. In addition, all individuals will receive a phone call every 2 month to assess~     adverse outcomes and compliance to treatment, supported by a hotline for immediate report of~     adverse events.~      Statistical power: We expect more than 80% power with 200 participants completing their 24~     month follow-up, and 260 participants completing their 12 month follow-up.~      This is a trial with medicinal product.~   "
225995|NCT00599794|"~     Patients may have actual or relative intravascular volume depletion in a number of different~     disease states, particularly with sepsis syndrome. However, it is clinically difficult to~     determine volume status without invasive monitoring, which may cause unintended~     complications. Our hypothesis is that we can accurately estimate central venous pressure,~     which is a surrogate marker of volume status, with a noninvasive portable ultrasound device.~   "
225996|NCT00599781|"~     This study investigated the safety and efficacy of different gene therapy approaches for~     Severe Combined Immunodeficiency (SCID) caused by the deficiency of adenosine deaminase (ADA)~     enzyme. This is a severe condition that can be cured by HLA-matched sibling donor bone marrow~     transplantation. Patients were enrolled if no HLA-identical sibling donor was available and~     the patient showed evidence of failure of enzyme replacement therapy or this treatment was~     not a long-term available option. The aim of the study was to evaluate the safety and~     efficacy of the procedure and to identify the relative role of peripheral blood lymphocytes~     and hematopoietic stem cells and progenitor cells in the long-term reconstitution of immune~     functions after retroviral vector mediated ADA gene transfer.~   "
225997|NCT00599768|"~     This prospective cohort and multi-site study aims to develop Taiwan version (ID Pain-T) based~     on the original versions of ID Pain and also DN4, and validate both ID Pain-T and DN4 applied~     in Taiwanese subjects at the clinical setting.~   "
225998|NCT00599755|"~     This study will use imaging to look at tumor response to combination chemotherapy of~     gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small~     cell lung cancer (NSCLC).~   "
225999|NCT00599742|"~     Previous studies report frequent comorbidity of anxiety and sensory-motor imbalance in adults~     (Sklare et al., 2001). Only a few studies tested the comorbidity in children. We confirmed~     that: a) children with primary diagnosis of poor balance demonstrate an elevated anxiety~     level (Brat et al., 2006, submitted) and, b) children with primary diagnosis of generalized~     anxiety disorder demonstrate poor balance performance (Erez et al., 2004). These studies~     demonstrate the presence of balance-anxiety comorbidity in children with primary disorder of~     either balance or anxiety. Our theoretical reasoning formalized under the three stage theory~     of learning points to the possibility that poor balance may either predispose or cause the~     emergence of anxiety disorder (Erez et al., 2004). Thus, in the present study we test two~     predictions: (a) high prevalence of comorbidity of anxiety and balance disorders in children~     with a primary diagnosis of generalized or separation anxiety disorder, and, (b) intensive~     balance training, but not training of flexibility and power, will reduce the level of anxiety~     in children with primary diagnosis of anxiety.~   "
226000|NCT00599729|"~     The purpose of the study is to evaluate the gait spatio-temporal parameters of patients with~     degenerative changes in the knee joint and to relate them with 2 questionares (WOMAC and~     SF-36).~   "
226001|NCT00599716|"~     The study is designed to assess the safety and efficacy of Vismed®, a special eye drop~     containing sodium hyaluronate, in the treatment of dry eye syndrome. Vismed® is being~     compared to another eye drop, identical in composition except that it does not contain the~     active ingredient, sodium hyaluronate. This eye drop is designed as the vehicle. Some~     subjects are to receive Vismed® treatment, while others are to receive the vehicle; the~     assignment of subjects to receive either Vismed or vehicle is to be random. The two-week~     treatment phase is followed by a one week follow-up period to evaluate safety of Vismed®.~   "
226002|NCT00599703|"~     The purpose of this study is to use an imaging method called functional magnetic resonance~     imaging (fMRI) in patients who have a tumor near an area of the brain that is believed to~     control language. The fMRI is a new kind of imaging that uses a strong magnetic field to look~     at functioning brain tissue. This kind of imaging will be used to study the effect of the~     brain tumor on your speech.~   "
226003|NCT00599690|"~     To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma~     after epi-LASIK Surgery.~   "
226004|NCT00599677|"~     The purpose of the study is to testify the efficacy of treating functional dyspepsia with~     acupuncture, and provide evidence for the hypothesis that Acupuncture effect is based on~     meridians, and gathering of meridian Qi is the key point.~   "
226005|NCT00599664|"~     Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy.~   "
226007|NCT00599638|"~     Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain,~     however, not all patients will respond to this drug. This study will compare the efficacy of~     pregabalin when administered with an experimental drug PF-00489791, in patients with~     post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin~     alone.~   "
226217|NCT00596791|"~     The purpose of this study is to investigate if changes in ocular signs and symptoms occur in~     patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005%~     (Xalatan) to preservative free Tafluprost eye drops.~   "
226008|NCT00599625|"~     The primary objective of this study is to provide data regarding clinical and immunologic~     activity of oral doses of pravastatin 80mg administered daily for 6 consecutive weeks, for~     the treatment of active Crohn's disease as shown by the Harvey-Bradshaw Index (HBI) and/or~     elevated C-reactive protein (CRP).~      We hypothesize pravastatin will significantly reduce symptoms of Crohn's disease, as shown by~     a decrease in HBI, by the end of the study period. Secondary outcomes of this study include~     the effect of pravastatin on C-reactive protein, ESR, proinflammatory cytokines, and fecal~     lactoferrin.~   "
226009|NCT00599612|"~     This will be an open label study conducted at one site. Six healthy male subjects will be~     enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single~     10 milligram (mg) oral dose of GW856553 containing 50 microCi (µCi) of [14C] GW856553. Urine~     and fecal samples will be collected until 216 hour after dosing but subjects may be~     discharged after 168 hour if 90% of the dose is recovered and/or <1% of the dose is excreted~     in a 24 hour period. Blood and plasma will be collected at various sample times after dosing~     to measure parent drug and total drug-related material. Samples of urine, faeces and plasma~     will be transferred into a separate study to characterize and quantify metabolites in these~     matrices. Safety will be assessed by adverse event monitoring, vital signs, electrocardiogram~     (ECG) and clinical laboratory tests.~   "
226010|NCT00599599|"~     The primary aim of this project is to examine the efficacy of prolonged exposure (PE) therapy~     at reducing HIV-related PTSD symptoms, increasing adherence to antiretroviral medication~     regimens, and increasing health-related quality of life (QOL) in HIV+ patients.~   "
226011|NCT00599586|"~     The purpose of the study is to testify whether acupuncture is effective for migraine, and~     provide evidence for the hypothesis thatAcupuncture effect is based on meridians, and~     gathering of meridian Qi is the key point.~   "
226012|NCT00599573|"~     The hypotheses of this study are:~        1. Ondansetron will show a decrease in cocaine use from baseline in individuals with HIV~          who are cocaine using.~        2. Ondansetron will show a decrease in cravings from baseline in individuals with HIV who~          are cocaine using.~      After informed consent and screening, HIV infected individuals who are cocaine dependent and~     qualify for the study will be offered ondansetron 4mg BID for six weeks in an open label~     format 4mg BID has been found to have efficacy compared to placebo. At screening and then at~     each visit, they will be asked to provide urine and a drug of abuse screen will be conducted~     to assess for cocaine. They will be asked to detail their recent cocaine use in the last~     month and then will be given a visual analog scale to assess their craving for cocaine. They~     will be asked to return weekly for 6 weeks to receive a week's supply of ondansetron and to~     give a urine sample that will test for cocaine. They will fill out a time line follow back~     for the past week and asked to assess their craving for cocaine on a visual analog scale.~   "
226013|NCT00599560|"~     Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to~     physical and/or psychogenic stress in their daily life. Meniere's disease is also a common~     inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized~     people under stressed life style. Its oto-pathology was firstly revealed in 1938 to be inner~     ear endolymphatic hydrops through the temporal bone study. To elucidate the neuroscientific~     relationship between stress and inner ear, we examined plasma vasopressin (the~     anti-diuretic stress hormone) and its receptor, V2R in the endolymphatic sac (the inner~     ear endo-organ for endolymph absorption) in Meniere's patients.~   "
226014|NCT00599547|"~     The purpose of this study is to determine whether a reduced intensity conditioning regimen~     followed by allogeneic stem cell transplantation is a feasible and effective treatment for~     patients with primary myelofibrosis.~   "
226015|NCT00599534|"~     Oral therapy with montelukast may lead to improved polysomnographic findings in children with~     mild to moderate OSAS with and without allergic rhinitis who a priori require T&A for OSAS.~      - A significant proportion of the children with OSAS treated with montelukast will show~     reduced severity of OSAS, and this will obviate the need for surgical T&A.~   "
226016|NCT00599521|"~     The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in~     the treatment of Acne Vulgaris.~   "
226017|NCT00599508|"~     To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on~     memory performance and brain function in older adults~   "
226018|NCT00599495|"~     The purpose of this study is to determine whether a reduced intensity conditioning regimen~     followed by allogeneic stem cell transplantation from unrelated donors is a feasible and~     effective treatment for patients with multiple myeloma who failed a previous autologous stem~     cell transplantation.~   "
226019|NCT00599482|"~     Most patients with sickle-cell disease have periodic intensely painful episodes. To manage~     this pain, we are proposing the drinking of at least 500 mL of water followed by far infrared~     radiation.~   "
226020|NCT00599469|"~     Alzheimer's disease is a progressive and fatal brain disease. This study will investigate the~     use of far infrared radiation treatment for the disease.~   "
226021|NCT00599456|"~     Hot flashes can be a disturbing symptom of menopause. Prescription medications are commonly~     used for symptom relief. Several non-prescription therapies are under investigation. This~     study will examine the use of omega-3 (fish oil) supplements to see if it helps relieve hot~     flashes and therefore improve the quality of life.~      Study Hypotheses:~      Menopausal women who take Omega 3 vitamins(fish oils)will show improvement in the severity of~     their hot flashes.In addition women who take Omega 3 supplements will show improvement in~     their lipid profiles.~   "
226022|NCT00599443|"~     A controlled, double blinded study to determine the safety and reactogenicity in healthy~     adults of a single dose of a trivalent cell-derived influenza vaccine administered by~     intramuscular injection.~   "
226023|NCT00599430|"~     The aim of the present prospective study is to investigate whether the consumption of certain~     probiotic strains over a six-month winter/spring season would be able to affect the incidence~     and duration of upper respiratory tract infections, in otherwise healthy children as well as~     determining whether a combination of two strains would perform differently from a single~     strain version.~   "
226063|NCT00598884|"~     This study will evaluate the effectiveness of an Internet-based self-help program in treating~     people who are at risk for developing prolonged grief disorder following a recent loss.~   "
226024|NCT00599417|"~     Primary~      - To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma~     after second period of treatment~      Secondary~        -  To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract~          infections symptoms through patient evaluation of fever or respiratory presence after~          second period of treatment~        -  To evaluate loss of working or study days after second period of treatment~        -  To evaluate the safety and tolerability of Pulmonarom in the population under study~   "
226025|NCT00599404|"~     Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400~     tablets from the same drug product batch.~   "
226026|NCT00599391|"~     Renal failure or kidney failure is a situation in which the kidneys fail to function~     adequately. It is divided into acute and chronic forms; either form may be due to a large~     number of other medical problems.~   "
226027|NCT00599378|"~     To assess the efficacy of a novel prompting intervention based on the concept of~     implementation intentions.~   "
226028|NCT00599365|"~     The purpose of this study is to see if a pharmacist can help patients understand how he/she~     should be taking their medications. The study is also being done to see if meeting with the~     pharmacist can help patients better control chronic kidney disease and the medical problems~     that can occur.~   "
226029|NCT00599352|"~     The purpose of this study is to determine how common low levels of magnesium are in patients~     with end stage liver disease. In addition, investigator is trying to determine if low levels~     of magnesium affect the release of parathyroid hormone in patients with end stage liver~     disease and low vitamin D levels~   "
226030|NCT00599339|"~     This study will be conducted in an observational multiple-cohort design aimed at acquiring~     clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD)~     will be enrolled.~   "
226031|NCT00599326|"~     To determine the efficacy and tolerability of deferasirox in the treatment of Porphyria~     Cutanea Tarda.~      Primary objective - the elimination of all blistering within 6 months of treatment.~      Secondary objective - decrease in total body iron levels.~   "
226032|NCT00599313|"~     The purpose of this research study is to find out what effects (good and bad) Sutent has on~     you and your prostate cancer.~   "
226033|NCT00599287|"~     The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled,~     doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or~     haloperidol in hypoactive ICU-delirium. In addition we will compare duration of delirium,~     severity of delirium, length of ICU/hospital stay and side effects between the different~     interventions.~   "
226034|NCT00599274|"~     The purpose of this study is to find out if weekly Avonex works as well as three times a week~     Rebif in subjects with relapsing multiple sclerosis.~   "
226035|NCT00599261|"~     To determine the effect of scar tissue removal on the rate of infection and any other~     complications such as bleeding in patients with an ICD or pacemaker who have the device~     generator or leads replaced or repositioned.~   "
226036|NCT00599248|"~     The study is being conducted to investigate the safety and activity of TissueGene-C injected~     into the knee joint of patients with chronic degenerative joint disease (DJD) who will be~     undergoing total knee replacement.~   "
226037|NCT00599235|"~     Hypertension (persistently elevated blood pressure) is a major risk factor for heart disease~     and stroke. Hypertensive individuals show a reduced exercise capacity, which is present from~     a very early stage and contributes to their increased cardiovascular risk. Sildenafil belongs~     to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, and it works by~     enhancing the effects of nitric oxide, a substance that dilates blood vessels and increases~     blood flow. We hypothesize that sildenafil, because of its effect on nitric oxide and blood~     flow, will improve exercise capacity in hypertensive patients. Therefore, the main aim of the~     study is to investigate the effects of PDE5 inhibition on exercise capacity and vascular~     function in hypertension, and to compare these effects in hypertensive patients and healthy~     controls.~   "
226038|NCT00599222|"~     Neovascular age-related macular degeneration (AMD) is the leading cause of severe vision loss~     in the Western world. Intravitreal ranibizumab has recently become the treatment of choice~     for neovascular (AMD). Limitations to ranibizumab however include the high cost for the drug~     and the need for frequent intravitreal re-injections. The investigators' hypothesis is that~     when ranibizumab is combined with transpupillary thermotherapy (TTT) the number of necessary~     retreatments with Lucentis will be significantly reduced as compared to ranibizumab alone.~   "
226039|NCT00599209|"~     The magnitude and intensity of medication use among our nation's 1.6 million nursing home~     residents matches or exceeds that of hospitalized patients. The residents of nursing homes~     are among the most frail patients in the population; the challenges of using medications in~     this setting are great, not only because of the physiologic declines and pharmacologic~     changes that occur with aging, but also because of the special clinical and social~     circumstances that often characterize nursing home care. In our previous research, we have~     determined that medication errors resulting in adverse drug events occur most often at the~     ordering and monitoring stages of pharmaceutical care. Clinical decision-support systems are~     clinical consultation systems that combine individual patient information with population~     statistics and scientific evidence to offer real-time information to health care providers.~     These systems have been found to improve the quality of medication prescribing in the~     hospital setting. In this study, we intend to determine the extent to which a computer-based~     clinical decision-support system (accompanying computerized provider order-entry) can improve~     the quality of medication ordering and monitoring for residents in the long-term care setting~     through a randomized trial. We will track the costs associated with this system and the~     system's impact on the productivity of providers. We will also assess the culture of U.S.~     nursing homes and the organization of the nursing home setting with respect to readiness to~     incorporate computerized provider order-entry with computer-based clinical decision support.~     Our project addresses specific areas that are of particular interest to AHRQ with special~     relevance to the delivery of high-quality care to a priority population--the frail elderly~     patient population residing in nursing homes. The project will assess the economic~     implications of health information technology in the nursing home environment that will be of~     interest to key stakeholders, including physicians, pharmacists, nurses, payers,~     policymakers, the nursing home industry, and pharmaceutical vendors to long-term care~     institutions.~   "
226040|NCT00599196|"~     The objective of this open-label extension is to assess the safety and tolerability of~     long-term treatment of the rotigotine patch in subjects with early-stage idiopathic~     Parkinson's disease~   "
226041|NCT00599183|"~     This is an investigator-iniated pilot study to determine if MRI with diffusion tensor imaging~     (DTI) and tractography will yield useful information in patients suspected of having cervical~     spine disc herniation to provide imaging confirmation of whether or not disease is~     progressing and to assess response to treatment (regardless of treatment provided).~   "
226363|NCT00594828|"~     To test the hypothesis that home international normalised ratio (INR) monitoring with~     supervised patient self-testing (PST)can provide comparable or superior time in therapeutic~     range (TTR) to that provided by traditional outpatient anticoagulation.~   "
226042|NCT00599170|"~     The use of R-CHOP, given every two weeks, will be associated with improvements in response~     rate, and progression-free survival, when compared to R-CHOP given every three weeks. The~     addition of sargramostim will allow safer adminIstration of the dose-intensified R-CHOP,~     while at the same time, improving the functional capability of the macrophages, and thus~     increasing the likelihood of improved clinical response and disease-free survival.~      The current phase II study is being proposed in order to develop preliminary data on the~     efficacy and toxicity of this approach, for future study in larger, phase III randomized~     trials. Laboratory correlates of response will also be studied, including activation markers~     on monocytes/macrophages before and after sargramostim exposure; and presence or absence of~     informative Fc gamma III polymorphisms.~   "
226043|NCT00599144|"~     Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine~     soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.~   "
226044|NCT00599131|"~     The purpose of this study is to learn how to identify early which patients will respond to~     chemotherapy plus radiation therapy in order to reduce the number of subjects who require~     surgery (followed by radiation therapy).~   "
226045|NCT00599118|"~     The purpose of this study is to establish a genebank repository of blood samples and data to~     generate information about the hereditary (genetic) basis of atrial fibrillation.~   "
226046|NCT00599105|"~     This study will investigate the association of angiogenesis in breast cancer measured by~     magnetic resonance imaging and biomarkers with long-term prognosis of patients.~   "
226047|NCT00599092|"~     The purpose of this study is to observe predictors of pituitary tumor recurrence and markers~     of persistent disease activity in patients harboring pituitary mass lesions of all types.~   "
226048|NCT00599079|"~     To determine the safety and efficacy of azithromycin in the treatment of lung infection with~     M.avium complex and M. abscessus lung disease.~   "
226049|NCT00599066|"~     The purpose of this study is to learn more about an Entropy monitor that the anesthesiologist~     will be using.~   "
226050|NCT00599053|"~     Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very~     low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the~     proinflammatory state caused by infection that puts them at risk for Bronchopulmonary~     Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age)~     treatment with intravenous azithromycin versus expectant management for VLBW infants with~     Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine~     microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for~     eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of~     infants in the two treatment groups and those without respiratory tract Ureaplasma spp.~     infection~   "
226051|NCT00599040|"~     The purpose of this study is to determine if what you eat affets your insulin sensitivity~     when you lose a small amount of weight~   "
226052|NCT00599027|"~     The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate~     nasal spray) in comparison with placebo in improving the quality of life of subjects with~     moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary~     objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of~     allergic rhinitis and asthma.~   "
226053|NCT00599014|"~     Heart failure is a very common cause of hospital admission and there are half a million new~     cases diagnosed each year in the United States. While some important progress has been made~     over the last two decades for the treatment of heart failure, there still remains a critical~     need for further advances in our understanding of this disease in order to significantly~     improve patient outcomes. Large numbers of heart failure patients need to be studied over~     time to allow scientists to investigate those factors that influence the responses to~     therapy.~   "
226054|NCT00599001|"~     The main purpose of this study is to assess the safety, tolerability, and biological activity~     of SD-101 compared with placebo in healthy male volunteers.~   "
226055|NCT00598988|"~     The purpose of this study is to investigate feasibility issues related to conducting an~     acupuncture study in a population of adolescents and young adults with infectious~     mononucleosis. Additionally, this study will provide preliminary data regarding treatment~     parameters (acupuncture and standard care) and outcomes (i.e. fatigue).~   "
226056|NCT00598975|"~     Study 07-PIR-02 is a Phase 2 study designed to evaluate the safety and efficacy of NKTR-102~     (PEG-irinotecan) for the treatment of patients with colorectal cancer (CRC). The study is~     comprised of two sequential components - Phase 2a and Phase 2b. The Phase 2a portion is an~     open-label, dose-finding trial in multiple solid tumor types that are refractory to standard~     curative or palliative therapies. The primary endpoint of the Phase 2a is to establish the~     /recommended Phase 2 Dose (RPTD) of NKTR-102 by measuring the frequency of Dose Limiting~     Toxicity (DLT). The Phase 2b portion is an open-label, randomized, two-arm study in patients~     with second-line metastatic colorectal cancer and study participants will be randomized (1:1)~     to receive either NKTR-102 and cetuximab or irinotecan and cetuximab. The primary endpoint of~     the Phase 2b portion of the trial is progression-free survival. Secondary endpoints for both~     the Phase 2a and 2b portion include response rate, response duration, overall survival,~     standard pharmacokinetics, and incidence of toxicities, including diarrhea and neutropenia.~   "
226057|NCT00598962|"~     To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three~     times weekly in the treatment of lung infection with M. avium complex(MAC)~   "
226058|NCT00598949|"~     The purpose of the study is to determine genetic links among blood-relatives and between~     spouses of patients with pituitary tumors.~   "
226059|NCT00598936|"~     The purpose of this study is to determine whether a new cerebral oxygenation monitoring~     device is comparatively similar to the current approved devices.~   "
226060|NCT00598923|"~     Our hypothesis is that topiramate will reduce acute seizures after traumatic brain injury and~     will help prevent the development of epilepsy after traumatic brain injury.~   "
226061|NCT00598910|"~     Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the~     lipid are decrease due to HAART treatment~   "
226062|NCT00598897|"~     To determine the safety and tolerance of clarithromycin given three times per week in~     combination with multiple drugs including rifabutin three times per week~   "
226064|NCT00598871|"~     As a consequence of damage to multiple organ systems throughout the course of their disease,~     diabetic patients suffer a number of chronic complications giving rise to increased~     morbidity, mortality, and health care costs specific to this population. Within the~     ophthalmic domain, diabetic retinopathy (DR) frequently induces serious visual impairment.~     Although DR can be addressed surgically, surgery remains a less than ideal intervention~     within this population with a well-characterized compromised ability to heal. The~     introduction of a therapeutic agent that could accelerate wound closure and decrease healing~     time, thereby reducing the risk and incidence of infection and corneal scarring in these~     susceptible patients, would represent a significant clinical and pharmacoeconomic advance in~     the treatment of this condition.~   "
226065|NCT00598858|"~     This pilot phase II trial studies docetaxel and prednisone in treating patients with newly~     diagnosed stage I-II prostate cancer undergoing prostatectomy. Drugs used in chemotherapy,~     such as docetaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Biological therapies, such as~     prednisone, may stimulate the immune system in different ways and stop cancer cells from~     growing. Giving docetaxel and prednisone together may kill more tumor cells.~   "
226066|NCT00598845|"~     The purpose of this prospective multicenter trial is to investigate the value of molecular~     markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation~     to treatment.~   "
226067|NCT00598832|"~     The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in~     the treatment of Acne Vulgaris.~   "
226068|NCT00598819|"~     The purpose of this study is to determine whether a new cerebral oxygen monitoring device is~     effective and comparatively similar to the current approved devices.~   "
226069|NCT00598806|"~     The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in~     randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of~     Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.~   "
226070|NCT00598793|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a~     standard dosing of insulin glargine plus metformin on blood glucose control in subjects with~     type 2 diabetes who are insulin naive and failing OAD therapy.~   "
226071|NCT00598780|"~     To evaluate over a period of 6 months the safety and the treatment satisfaction of newly~     prescribed levocetirizine in patients of age ≥ 2 years with persistent allergic rhinitis.~   "
226072|NCT00598767|"~     NASA has outlined the most urgent threats to life and health in manned spaceflight. One of~     the threats is the risk of trauma and acute medical problems. One of the most important~     provisions of acute and chronic medical services in space is the availability of high quality~     diagnostic imaging with the potential for either ground based or onsite interpretation. The~     principle diagnostic imaging modality for space crew use in space will be ultrasound. The aim~     of the study is as follows:~      -To use state of the art 3 dimensional CT scanner to acquire images for segmentation and~     registration supplying a template to judge physiologic or pathologic changes observed in~     space with 3D ultrasound~   "
226073|NCT00598754|"~     The purpose of this study is to perform ground-based research to study what happens to the~     heart muscle in space. People who have problems with their aortic valve have an increase in~     the amount of muscle in the left ventricle of the heart. After valve surgery, the amount of~     muscle should decrease and return to normal. Astronauts lose heart muscle mass during space~     flight. Our study will look at these changes in your heart, which we believe are similar to~     what happens during long term space travel.~      This study will look at the accuracy of three dimensional ultrasound imaging (echo) in~     monitoring the changes in heart size and function following aortic valve replacement. We are~     studying ways to prevent health-related problems that men and women will face on~     long-duration space missions.~      The hypothesis is that serial two dimensional and three dimensional echo will show accurate~     changes in the left ventricle mass and volume following aortic valve replacement for aortic~     stenosis or regurgitation~   "
226074|NCT00598741|"~     The purpose of this study is to see whether fast imaging with MRI and the usual contrast~     material used for MRI, predicts which patients will do well with treatment. Some studies~     suggest that MRIs done right before surgery may be able to tell how much of the cancer was~     killed by the chemotherapy. This study will see if this is true in patients with osteogenic~     sarcoma (OS) and Ewing's sarcoma (ES). This study will also see if MRIs done early in~     treatment can tell if the chemotherapy is working.~   "
226075|NCT00598728|"~     The purpose of this study is to collect information on the long-term side effects of~     treatment for Hodgkin Lymphoma. We hope to study about 500-800 survivors of Hodgkin Lymphoma.~     We plan to use the findings from this study to better understand Hodgkin Lymphoma survivors'~     health and quality of life.~   "
226076|NCT00598715|"~     For lesions which develop restenosis after a drug-eluting stent, it is not known which the~     right strategy to use is, implantation of the same type of DES as the initial one or a DES~     with a different drug.~   "
226077|NCT00598702|"~     Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when~     administered at a daily dose of 40 to 75 mg/kg body weight~   "
226078|NCT00598689|"~     GenTeal gel is an artificial tear gel used to lubricate the surface of the eye. This study~     will evaluate the effect of GenTeal gel on comfort following LASIK surgery. Participants will~     be asked to come to the clinic for three regularly scheduled visits after LASIK surgery: Day~     1 (one day after LASIK surgery), Day 7 (one week follow-up), and Day 30 (one month~     follow-up). Participants will be asked to complete a questionnaire regarding eye comfort~     during each follow up visit. Participants will be randomly assigned to one of two groups, one~     of which will receive Genteal Gel four times a day for five days prior to surgery. The other~     group will receive no preoperative gel or lubricant, which has been our standard approach for~     many years.~   "
226079|NCT00598676|"~     The aim of this study is to determine whether biodegradable polymer based rapamycin-eluting~     stent performs equal to permanent polymer based everolimus- and rapamycin-eluting stents~     regarding reduction of adverse cardiac events at one year.~   "
226509|NCT00592917|"~     The purpose of this study is to determine the effect of calcium 1000 mg/d and vitamin-D3 800~     IU/d divided in two daily doses on the incidence of falls and fractures, bone mineral density~     and bone metabolism in postmenopausal women 65-71 years of age.~   "
226080|NCT00598663|"~     The primary objective of this study is to evaluate whether the patients with Type 1 diabetes~     mellitus in sub-optimal glycemic control can achieve better glycemic control by using the~     Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus~     the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose~     (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to~     control group, after 6 months of treatment.~   "
226081|NCT00598650|"~     The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with~     Dementia with Lewy Bodies (DLB).~   "
226082|NCT00598637|"~     The purpose of this study is to evaluate the efficacy of two different drug-eluting stents~     (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery~     disease.~   "
226083|NCT00598624|"~     This is a multicentric, non-randomized, non-controlled open-label phase II trial to evaluate~     the safety and efficacy of treosulfan in a combination regimen with fludarabine as~     conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with~     haematological malignancies.~      The aim is to demonstrate a clinical benefit compared with historical data on intravenous~     busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication~     conditioning before allogeneic stem cell transplantation.~   "
226084|NCT00598611|"~     The purpose of this study is to compare urticaria lesions (size, kinetics) by thermography,~     volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg~     or desloratadine 20 mg. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the~     treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).~   "
226085|NCT00598598|"~     The National Space Biomedical Research Institute is interested in learning more about heart~     function in space. One potential problem with long duration, manned space flight is muscle~     loss- including loss of heart muscle. One goal of our research is to help identify why this~     muscle loss occurs. We are interested in patients undergoing aortic valve surgery because~     this procedure is performed to correct a problem with the valve that may also change heart~     function. This change in heart function may provide information that is useful in~     understanding and potentially preventing the loss of cardiac muscle in space.~      Three patient groups will be studied, patients having surgery for aortic regurgitation,~     aortic stenosis, and coronary bypass. We are planing to perform this study on 30 patients, 10~     in each group.~      The aim of this study is to continue our ongoing study of the magnitude and predictors of the~     changes in size of the left ventricle following acute volume and pressure unloading as a~     ground-based analog for manned space flight.~   "
226086|NCT00598585|"~     Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)~   "
226087|NCT00598572|"~     Animal studies show that the breakdown of blood results in iron accumulation in the brain~     after brain hemorrhage (ICH); and that iron plays a role in brain injury in ICH patients.~     Deferoxamine (DFO) has been extensively used in clinical practice for more than 30 years to~     remove excessive iron from the body, and has been shown to provide some benefit in animal~     studies of ICH. Therefore, we plan to undertake this study to evaluate the safety and~     tolerability of treatment with DFO in patients with ICH, and to determine the maximal~     tolerated dose to be used in future studies to determine if treatment with DFO can improve~     the outcome of patients with ICH.~      Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of DFO,~     by determining the treatment related adverse events, in patients with ICH; and 2) to~     determine the maximal tolerated dose to be adopted in subsequent studies to test the efficacy~     of DFO in improving outcome after ICH.~      We hypothesize that DFO is well-tolerated and has minimal serious adverse effects in patients~     with ICH; and that treatment with DFO will improve patients' outcome. The results can~     potentially bring into account new means to improve the outcome of patients with ICH. ICH is~     a frequent cause of disability and death. A successful study demonstrating the efficacy of~     iron-modifying therapy would be of considerable public health significance.~   "
226088|NCT00598559|"~     The study will be investigating safety and efficacy administration of repeated dose of IV~     Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult~     patients.~   "
226089|NCT00598546|"~     The purpose of this study is to find out how you feel about the quality of your life after~     having had surgery to remove your stomach tumor. Some patients continue to experience~     different problems after stomach surgery, even when the surgery was more than three years~     ago. The purpose of this study is to find out the specific things that may continue to affect~     patients' quality of life after a major operation.~   "
226090|NCT00598533|"~     The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting~     stents for the reduction of Coronary Restenosis~   "
226091|NCT00598507|"~     The purpose of this study is to find out how effective an investigational drug named ZK-Epo~     is against melanoma. Although ZK-Epo has been studied in the treatment of cancer, it is not~     approved for use in treating melanoma. This research is being done because currently there~     are only a limited number of treatment options for patients who have melanoma that has spread~     to distant organs.~      We expect each patient to be in this study for at least 2 cycles. One cycle lasts for 21~     days. If their tumor does not grow after 2 cycles and they do not have any major~     side-effects, they may receive up to 6 cycles of ZK-Epo.~      If after they have received 6 cycles of ZK-Epo and their doctor determines that the tumor is~     continuing to shrink, they will continue treatment with ZK-Epo. The number of treatments the~     patient receives after 6 cycles will depend upon when their doctor feels there has been~     maximum tumor response (tumor shrinkage). Two treatments will be given beyond what their~     doctor considers the point of maximum shrinkage. We estimate that they will spend anywhere~     from 1 1/2 months to 5 months taking part in this study.~   "
226114|NCT00598182|"~     The objectives of this study are to investigate:~        1. the evolution of ADHD symptoms, remission rate of ADHD, social and school function, and~          familial relationship;~        2. the adherence to CONCERTA, treatment modality, and average treatment duration during the~          3-year follow-up period; and~        3. the effect of medication on the changes of neuropsychological functioning.~   "
226218|NCT00596778|"~     Abdominal surgical procedures can increase risks of pulmonary complications.The aim of the~     study was to evaluate the benefits of an early intervention of chest physiotherapy during~     immediate post-operative in patients submitted to elective abdominal surgery.~   "
226092|NCT00598494|"~     The purpose of this research sub-study is to determine the changes in heart function during~     the bedrest period using ultrasound and MRI. This topic is important for medical care of~     astronauts in space. It can enable physicians on the ground to monitor exercise protocols~     that are used to prevent deconditioning-loss of strength during long space flights.~      Your participation in this study would include ultrasound examinations with bicycle exercise~     before, during, and after the 12-week bedrest period. MRI exams would be performed before and~     after the bedrest period.~      Each echo exam may last up to 1 hour. This time will be required to perform an ultrasound~     examination before and during supine (lying down) bicycle exercise. The exercise period will~     be approximately 10-15 minutes. The bicycle exercise will be a symptom-limited test. This~     means that the test will be stopped if you experience any discomfort. An ultrasound~     examination of your heart will be done to assess heart function. You will be asked to lie on~     your left side on an examination table while a technician takes pictures of your heart with a~     small probe that is gently pressed against your chest after applying a gel. The ultrasound~     data will be processed to evaluate myocardial strain, a value that may be useful in~     describing heart function.~      Each MRI may last up to 1 hour. An MRI obtains body pictures created by using magnetic energy~     rather than x-ray energy. To have the scan, you will lie on a table that slides into the~     scanner, which is like a large tube. An MRI examination of your heart will be done to assess~     heart function. You will be asked to lie still and follow simple breathing instructions~     during the procedure. The MRI data will be processed to evaluate the volume of blood being~     pumped by your heart, a value that may be useful in describing heart function.~   "
226093|NCT00598481|"~     This is a phase I/II protocol to evaluate the safety and efficacy of ADA gene transfer into~     hematopoietic stem/progenitor cells for the treatment of adenosine deaminase~     (ADA)-deficiency. This condition is an autosomal recessive form of Severe Combined~     Immunodeficiency (SCID) characterized by impaired immune responses, recurrent infections,~     failure to thrive and systemic toxicity due to accumulation of purine metabolites.~     Transplants from an HLA-identical sibling donor is the treatment of choice, but available for~     a minority of patients. The use of alternative bone marrow donors or enzyme replacement~     therapy is associated with important drawbacks. The drug product studied in this protocol~     consists of autologous CD34+ hematopoietic stem/progenitor cells engineered ex vivo with a~     retroviral vector encoding the therapeutic gene ADA. The engineered CD34+ cells are infused~     following a nonmyeloablative conditioning with busulfan to make space in the bone marrow. The~     study objectives are: a) to evaluate the safety and the clinical efficacy of gene therapy, in~     the absence of enzyme replacement therapy; b) to evaluate the biological activity~     (engraftment, ADA expression) of ADA transduced CD34+ cells and their hematopoietic progeny.~     c) to evaluate the immunological reconstitution and purine metabolism after gene therapy.~   "
226094|NCT00598455|"~     Eighty percent of patients with tuberous sclerosis complex (TSC) have renal angiomyolipomata.~     These lesions grow and can lead to significant morbidity by hemorrhage or renal failure.~     Understanding the natural history of these lesions and understanding which lesions may be~     more prone to grow quickly or develop aneurysms that predispose to hemorrhage will greatly~     assist clinical care of patients with TSC. The objective is to test the hypothesis that~     serial MR and CT imaging will allow objective, reproducible quantification of angiomyolipoma~     growth by volumetric analysis, and analysis of lesions characteristics will identify~     angiomyolipomata with rapid growth potential that would require intervention. The specific~     aim of this proposal is to collect clinically obtained serial abdominal imaging from the~     Tuberous Sclerosis Natural History Consortium Centers and analyze the volume and adiposity of~     the individual angiomyolipomata. The growth rate is hypothesized to have an inverse~     relationship to adiposity. Yearly renal MR or CT imaging will be performed of patients with~     TSC. The images will be coded at the site of acquisition, and transferred via VPN to a secure~     server at Cincinnati Children's Hospital Medical Center. Using innovative imaging processing~     software (Cincinnati Children's Hospital Image Processing Software (CCHIPS), the image data~     will be segmented to reveal various tissue components based on signal intensities. Different~     signal intensities can differentiate normal renal parenchyma, and renal angiomyolipomata.~     Using the imaging data and the novel software, the volume of an individual angiomyolipoma, as~     well as the adiposity will be determined. Imaging at enrollment (year 1) will serve as~     baseline. At years two and three, the lesions will undergo repeat analysis. Angiomyolipoma~     growth rates and adiposity over three years will be analyzed to test the hypothesis above.~   "
226095|NCT00598442|"~     The purpose of this study was to evaluate the safety and efficacy of peginesatide for the~     treatment of anemia in participants with chronic kidney disease, who are not on dialysis and~     not on erythropoiesis stimulating agent (ESA) treatment.~   "
226096|NCT00598429|"~     This pilot study was a randomized, placebo-controlled, clinical trial to test the safety of~     using the intravenous form of Prostaglandin E1 (PGE1) in an inhaled form for treatment of~     hypoxemic respiratory failure in term newborns. The study planned to enroll 50 infants~     diagnosed with hypoxemic respiratory failure at nine NICHD Neonatal Research Network sites,~     and randomly assign them to receive one dose over a 72-hour period of either high~     concentration PGE1 (300 ng/kg/min), low concentration PGE1 (150 ng/kg/min), or placebo~     (normal saline, the diluent for the drug). In addition to determining the safety, optimal~     dose, and duration of the therapy, this pilot trial planned to evaluate the feasibility of~     conducting a larger, multi-center randomized, blinded placebo-controlled trial.~   "
226097|NCT00598416|"~     The proposed project will apply a unique, effective family-responsive psychoeducation~     program, PsychoEducation Responsive to Families (PERF), for Hepatitis C Virus (HCV)~     treatment. The goal is to demonstrate that the intervention will enlarge the eligibility of~     some patients for HCV treatment and help sustain others through it.~   "
226098|NCT00598403|"~     The main objective of the study is to comparatively assess the efficacy and tolerability of~     the drugs under study in the treatment of acute uncomplicated cystitis.~   "
226099|NCT00598390|"~     The purpose of this protocol is to measure brain CB1 receptors in the hope to better~     understand how they work, so that one day we can understand how the CB1 receptors are~     involved in psychiatric, neurological, and behavioral disorders.~   "
226100|NCT00598377|"~     We aimed to evaluate the hypothalamus-pituitary-adrenal axis in autosomal dominant polycystic~     kidney disease (ADPKD) patients. Twenty two ADPKD patients and 27 healthy subjects were~     enrolled.~   "
226101|NCT00598364|"~     The purpose of this study is to evaluate how common gene mutations are in benign and~     malignant thyroid lesions.~   "
226126|NCT00598013|"~     The aim of this study was to evaluate the effect of pioglitazone treatment on insulin~     secretion, insulin resistance, and progression of atherosclerosis in renal allograft~     recipients without preoperative history of diabetes.~   "
226127|NCT00598000|"~     The purpose of this study is to see if different types of surgery for lung cancer have~     different effects on quality of life and pain. What we learn from this study may help us find~     new ways to improve the quality of life of lung cancer patients who have surgery.~   "
226102|NCT00598351|"~     This study will examine over the long-term the progress of patients with neurofibromatosis~     Type 2 (NF2), a condition associated with tumors of the nerves, brain and spinal cord. It~     will study patients tumors to learn how fast they can grow and if certain factors might~     affect their growth. It will also examine the effects of the tumors on patients abilities to~     carry out activities of daily living.~      People between 8 and 75 years of age with NF2 may be eligible for this study. Participants~     undergo the following procedures:~      Initial evaluation, including hearing, eye and balance testing, gait (walk) testing, magnetic~     resonance imaging (MRI) scans of the brain and spine, blood tests, and physical and~     neurological examinations.~      MRI scans of the brain and spine every 6 months to follow the size and number of tumors.~      Physical and neurological examinations and blood tests every 6 months.~      Auditory tests every 12 months. These tests evaluate middle and inner ear function and the~     patient s ability to hear tones at different frequencies and to hear words at different~     volumes. The subject responds to tones and words that are delivered through earphones.~      Eye examination every 1 to 2 years.~      Gait testing every 12 months if a spinal cord tumor causes problems with sensation or muscle~     control in the arms and legs Subjects joints are measured while they walk across a room~     several times as scientific cameras record their movements.~      Vestibular testing if the patient experiences changes in balance or undergoes treatment for~     vestibular schwannoma (a tumor that develops on the hearing and balance nerves). These tests~     check the function of various components of the balance system (eyes, inner ear, or leg and~     body sensation and muscles). They include:~        -  Videoelectronystagmogram Tracks subjects eye movements while they follow moving red~          lights with their eyes.~        -  Vestibular evoked myogenic potential Assesses subjects neck muscle movements in response~          to noise.~        -  Posturography Determines which parts of the balance system the subject relies on most.~          Subjects stand on a platform and try to maintain their balance while changes are made to~          the platform and the environment.~        -  Rotary chair test Subjects eye movements are monitored as they follow red spots and~          strips of light with their eyes while seated in a rotary chair that turns side to side~          at several speeds.~   "
226103|NCT00598338|"~     The purpose of this study is to determine whether prucalopride is safe and effective in the~     re-treatment of chronic constipation.~      Hypothesis:~      Retreatment is as effective and safe as treatment with prucalopride in patients with chronic~     constipation.~   "
226104|NCT00598325|"~     Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for~     anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule~     so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether~     changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating~     antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1~     adds a 6th dose at week 26, and extends follow-up through week 52.~   "
226105|NCT00598312|"~     The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for~     Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients~     with prostate cancer.~   "
226106|NCT00598299|"~     Human serum eye drops have been successfully used in the treatment of severe ocular surface~     disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven~     to be effective in treatment of dry eye and persistent corneal epithelial defects. However,~     there are limited studies comparing the corneal epithelial wound healing promoting effects~     between these two blood derived products. The purpose of this study is to test the corneal~     epithelial wound healing promoting effects between auto serum and human cord blood serum.~     Primary cultured bovine corneal epithelial cells were used as the model to investigate wound~     healing, cell proliferation and migration by means of scratch corneal wound healing assay~     evaluation, MTS assay and Boyden chamber migration assay in response to human serum and~     umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared~     between human serum and umbilical cord serum with ELISA kits.~   "
226107|NCT00598286|"~     The purpose of this protocol is to measure brain CB1 receptors in the hope to better~     understand how they work, so that one day we can understand how the CB1 receptors are~     involved in psychiatric, neurological, and behavioral disorders.~   "
226108|NCT00598273|"~     The purpose of this study was to evaluate the safety and efficacy of peginesatide for the~     treatment of anemia in participants with chronic kidney disease, who are not on dialysis and~     not on erythropoiesis stimulating agent (ESA) treatment.~   "
226109|NCT00598260|"~     This is a prospective randomized cohort study of obstetric patients from Paley clinic at AEMC~     and from other affiliated obstetric clinics.~      This study will try to determine if active management of risks in pregnancy at term by~     inducing patients will not decrease the cesarean delivery rate or change neonatal outcomes.~      The outcomes that will be measured include cesarean delivery rate, meconium, Apgar scores and~     admissions to the NICU.~   "
226110|NCT00598247|"~     This study uses the drug PPX (also called Xyotax and CT-2103) in women with advanced~     colorectal cancer. PPX is an experimental drug that has not been approved by the Food and~     Drug Administration (FDA). PPX has been shown in the laboratory and in studies in humans to~     cause some cancer cells to die and some tumors to shrink. Women in some studies with PPX have~     been shown to live longer than the men that receive the drug. Some studies in humans suggest~     that estrogen (a hormone found in women) may protect women from getting colorectal cancer and~     allow women that do get colorectal cancer to live longer than men that do.~      The purpose of this study is to see if women with colorectal cancer and a certain level of~     estrogen experience tumor shrinkage after they receive the drug PPX. This study will also~     study genes (genes are the cell's blueprint) in participant's tumors and in their blood.~     Several genes can affect how people's bodies react to the cancer drugs. We want to see if~     these predict response to the study drugs.~   "
226111|NCT00598234|"~     We propose that administration perioperative celecoxib is effective to control postoperative~     VAS pain scores, improve rehabilitation results, and decrease narcotics usage in total knee~     replacement patients.~   "
226112|NCT00598208|"~     The primary objective of this trial is to investigate the dose -response relationship of a~     single injection of Org 38286 to initiate multifollicular growth for the first seven days in~     a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.~   "
226113|NCT00598195|"~     What are the pharmacokinetics of ketamine in infants and children requiring ketamine for~     induction of anesthesia for cardiac surgery that requires CPB? Specific Aim 1: To determine~     the pharmacokinetic parameters of a single intravenous bolus dose of ketamine in infants and~     children undergoing cardiac surgery with and without CPB (cardio-pulmonary bypass).~      Specific Aim 2: To describe the disposition of ketamine's primary active metabolite,~     norketamine,following a single intravenous bolus dose of ketamine in infants and children~     undergoing cardiac surgery with and without CPB.~      Specific Aim 3: To determine the relationship between ketamine and norketamine~     pharmacokinetic parameters and age as well as CPB time.~   "
226219|NCT00596765|"~     Acquired brain injury can result in impaired everyday functioning as well as psychosocial~     problems, including depressive symptoms, irritability, or negative self-concept. The purpose~     of this study is to determine whether a combination of neuropsychological and cognitive~     behavioral therapy is effective in the treatment of these sequelae.~   "
226115|NCT00598169|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,~     such as dexamethasone, ifosfamide, carboplatin, and etoposide, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. It is not yet known whether giving~     bortezomib together with combination chemotherapy is more effective with or without rituximab~     in treating AIDS-related non-Hodgkin lymphoma.~      PURPOSE: This clinical trial is studying giving bortezomib together with dexamethasone,~     ifosfamide, carboplatin, and etoposide to see how well it works with or without rituximab in~     treating patients with relapsed or refractory AIDS-related non-Hodgkin lymphoma.~   "
226116|NCT00598156|"~     Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will~     continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab~     and erlotinib (Tarceva).~   "
226117|NCT00598143|"~     Doctors at MSKCC are doing this research study to see if smokers are interested in the idea~     that genes might be markers of cancer risk, and to see if smokers would want to learn this~     information about their risk if it were available.~      Different versions of the gene called UGT1A7 are found in different people. Certain versions~     of this gene can increase the risk of cancer in people. In this study, doctors will determine~     the different types of UGT1A7 in smokers and find out whether smokers show good interest and~     understanding. The information from this study will be used in future studies to identify~     smokers at increased risk for cancer, and to help smokers quit.~   "
226118|NCT00598130|"~     This is a prospective, randomized, single blind, standard care- controlled study, which will~     include a total of 30 patients divided into two treatment arms: First are: patents who will~     be treated in accordance with standard of care. Second arm: patients for which the Fibrin~     Fleece will be applied directly on the active bleeding site.~   "
226119|NCT00598117|"~     The goal of this study is to evaluate how treatment for esophageal cancer affects your~     quality of life. The findings of this study may help us understand how this disease and its~     treatment affect your lifestyle, diet, exercise, support system and overall quality of life.~     We hope this study will provide important information that can be used to develop programs to~     improve the quality of life of patients with esophageal cancer.~   "
226120|NCT00598104|"~     This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults~     with moderate persistent allergic asthma~   "
226121|NCT00598091|"~     The purpose of this study is to find the highest dose of the drugs gemcitabine and dasatinib~     that can be given for the treatment of pancreatic cancer. Gemcitabine (also called Gemzar™)is~     a drug that is given intravenously. Dasatinib (also called Sprycel™) is a tablet and will be~     taken by mouth.~      Gemcitabine is approved by the Food and Drug Administration (FDA) for the treatment of~     advanced breast, lung and pancreatic cancer. Dasatinib is approved by the FDA for the~     treatment of chronic myeloid leukemia (CML), acute lymphoblastic leukemia or for patients~     that are resistant to imatinib mesylate (Gleevec™ ).~      This study will try to find the highest doses of these drugs that can be tolerated when taken~     in combination. The study will also look at how the drugs work in the body, and will see if~     there is any effect on pancreatic cancer.~   "
226122|NCT00598078|"~     To determine the relationship between drug plasma levels and safety, tolerability and~     efficacy in patients with essential tremors after dosing with Sodium oxybate~   "
226123|NCT00598065|"~     The purpose of this study is to see if researchers can improve the detection of lung cancer~     by using a new method which will help us to take multiple snapshot images of the lungs while~     the patient is breathing. We are also investigating whether with the help of this new method~     we can better measure the actual amount of radioactivity that is taken up by the cancer. The~     name of this new method is respiratory gated PET/CT. Previous research has shown that PET~     scans may be useful in investigating whether cancer has spread to other parts of the lung or~     body. Using our standard method, smaller cancers are sometimes difficult to detect in the~     lungs because the PET images are taken over several minutes and the patient is breathing~     during that time. That means the cancer may appear blurred on the images (like a poor~     photograph) or may not be identified at all. In this study, in addition to the images that~     were ordered by your doctor, we will take additional images of your lungs while you are~     following a breathing command (breath in-hold-breath out). We will then compare the images~     of your cancer during the regular PET study with those taken during the breathing commands.~      The hypotheses to be tested in this pilot study are:~        1. Respiratory gated image acquisition reduces partial volume effects on PET image that may~          render lung lesions undetectable.~        2. Breath-hold CT may detect small lung lesions that are beyond the limit of detection in~          shallow-breathing CT scans, related to respiratory motion which causes blurring~          artifacts around smaller lung lesions.~   "
226124|NCT00598052|"~     Recent studies have established the reliability, validity and time course of the cannabis~     withdrawal syndrome. This study will investigate the effects of combined treatment of~     Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana~     withdrawal syndrome in regular chronic users of marijuana. We predict that combined~     pharmacological treatment and cognitive-behavior therapy will help patients to abstain from~     using using marijuana and it will alleviate their marijuana withdrawal symptoms.~   "
226125|NCT00598026|"~     The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing~     mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of~     this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits~     are scheduled every 3 months. In this context, the recently-introduced remote monitoring~     devices constitute a promising new technique, allowing to transmit information about the~     status of the device and ICD therapies, without direct contact between patients and~     physicians. This monitoring by tele-follow-up might reduce the cost of care by avoiding~     useless visits to the implantation centre.~      The aim of our study is to assess the cost-benefit ratio of tele-follow-up assisted care as~     compared with the conventional ICD follow-up.~   "
229184|NCT00557024|"~     The purpose of the investigators study is to prospectively evaluate whether radiotherapy as~     an adjuvant therapy after RFA will improve the outcome of radiofrequency ablation for~     hepatocellular carcinoma (HCC) or not.~   "
226128|NCT00597987|"~     The purpose of this study is to collect a blood sample from patients that may be used for~     research purposes. These blood samples will be used by researchers at this institution to~     study the causes of breast and ovarian cancer, and to better understand how these cancers~     develop. We are trying to discover differences in the ways cells work in women with a high~     genetic risk of developing breast or ovarian cancer. Early data suggest that some genes may~     be turned on or off in different ways based upon whether or not a woman has a high genetic~     risk of developing breast or ovarian cancer. The primary objective is to test the hypothesis~     that BRCA1 haploinsufficiency regulates gene expression on the X chromosome. This hypothesis~     will be tested by comparing the gene expression profiles of BRCA1 heterozygotes (cases) to an~     age-matched group of unaffected women who are not BRCA1 mutation carriers (controls).~   "
226129|NCT00597974|"~     The purpose of this study is to determine how well patients undergoing carotid artery~     angioplasty and/or stent-supported angioplasty for the treatment of carotid artery stenosis~     will perform on a battery of tests to assess brain function before and after the procedure.~     This study will serve as a pilot project: (a) to determine incidence of~     neurologic/neuropsychometric change in patients undergoing carotid artery angioplasty and/or~     stent-supported angioplasty, and (b) to ascertain the time it takes for these changes to~     resolve.~   "
226130|NCT00597961|"~     There are two goals of this research study. First, we hope to develop a plan to guide family~     discussions that can help parents diagnosed with lung cancer talk about cancer risk with~     their adult children. Second, we want to understand how families talk about cancer~     prevention.~   "
226131|NCT00597948|"~     Relatively few health promotion and disease prevention programs have included or targeted~     people with disabilities, and even fewer have focused on individuals with intellectual~     disabilities.~      The long-term objectives of the Healthy Lifestyles for People with Intellectual Disabilities~     Study (HLID) are to increase the health of persons with intellectual disabilities by~     establishing the efficacy of a health promotion program and promoting its adoption. The HLID~     Study is based in the Center on Community Accessibility (CCA) at Oregon Health & Science~     University. The mission of CCA is to increase the health and health-related quality of life~     of persons with disabilities.~      A pilot study conducted by CCA has established the effectiveness of the Healthy Lifestyles~     (HL) intervention among a cross-disability population in increasing health behavior adoption.~     The specific aim of the HLID Study is to test the efficacy of the HL program specifically~     with adults with intellectual disabilities.~      The HLID Study uses a randomized control study design. The HL intervention will be~     administered to 75 adults and will compare results to those of an additional 75 adults who~     receive no intervention. Measurement will include anthropometric assessments to measure~     impacts on overweight and obesity, as well as self-report measures of healthy behaviors,~     health status, health care utilization, and secondary conditions. Results will be shared with~     research participants, presented through professional conferences and newsletters, and~     published in peer-reviewed journals with the assistance of community partners.~   "
226132|NCT00597935|"~     Pelvic organ prolapse is common among women with a prevalence that has been estimated to be~     as high as 30%. Pelvic organ prolapse often involves a combination of support defects~     involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal~     wall is the segment most likely to demonstrate recurrent prolapse after reconstructive~     surgery, reoperations are highest among those who require apical suspension procedures with~     or without repair of other vaginal segments (12%-33%). Despite the substantial health impact,~     there is a paucity of high quality evidence to support different practices in the management~     of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle~     Training in the Management of Apical Support Loss (OPTIMAL) Trial are:~        1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament~          suspension (ULS); and~        2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in~          women undergoing vaginal surgery for apical or uterine prolapse and stress urinary~          incontinence.~   "
226133|NCT00597922|"~     Heart disease and heart attacks pose a serious health risk to young women, and women tend to~     experience less successful recoveries after a heart attack than men do. This study will~     examine various factors that may predispose women to heart attacks and to poor recovery after~     a heart attack. The differences between men and women in the medical care that they receive~     following a heart attack will also be studied.~   "
226134|NCT00597909|"~     The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in~     subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).~   "
226135|NCT00597896|"~     The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be~     able to improve cognitive problems (i.e. difficulties with thinking, memory, and~     concentration) that may be associated with bipolar disorder.~   "
226136|NCT00597883|"~     The purpose of this study is to determine how well patients undergoing carotid endarterectomy~     will perform on a battery of tests to assess brain function before and after surgery as~     compared to a control group of patients undergoing spine surgery. This study will serve to:~     (a) determine incidence of neurologic/neuropsychometric change in patients undergoing carotid~     artery surgery, and (b) to ascertain the time it takes for these changes to resolve.~   "
226137|NCT00597870|"~     The primary objective of this trial is to determine whether the Talent Thoracic Stent Graft,~     an investigational device, is a safe and effective method of treating thoracic aortic~     aneurysms (abnormal ballooning of the vessel wall) and other thoracic lesions (dissections,~     transections, pseudoaneurysms, penetrating ulcers, etc.). The endovascular method is a~     substitute for the major operation that is performed to treat the lesions.~   "
226149|NCT00597714|"~     The central hypothesis of this study is that use of a less toxic chemotherapy preparative~     regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell~     depletion with alemtuzumab for patients with high risk hematologic malignancies will allow~     effective control of disease and improved disease free and overall survival compared with~     historical expectations. Specifically, the objectives are to estimate toxicity, disease free,~     progression free, event free, and overall survival rates in patients treated with alemtuzumab~     T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic~     transplantation; evaluate immune recovery following this reduced intensity allogeneic~     immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.~   "
226138|NCT00597857|"~     People experience a wide range of outcomes following a traumatic event. Although rates differ~     depending on type of trauma, 20-60% of trauma victims may develop posttraumatic stress~     disorder (PTSD). However, not all trauma victims develop PTSD. Previous research has found~     that trauma victims who develop PTSD excrete lower levels of urinary cortisol immediately~     after a trauma than victims who do not develop PTSD. Other research has suggested that~     increasing levels of cortisol may protect against the development of PTSD in patients such as~     yourself- but this has not yet been examined. Cortisol is a naturally occurring hormone in~     your body, and the present study is designed to test whether increasing cortisol levels can~     protect against or decrease symptoms of PTSD. Participants in this study will be randomly~     assigned to one of two treatment groups. Participants will receive either hydrocortisone~     (20mg, twice per day) or a placebo (a sugar pill) for 10 days with a six-day taper. There is~     an equal chance of being in either treatment group, and neither the participant nor the~     experimenters will know which treatment was received (except in case of an emergency).~   "
226139|NCT00597844|"~     The purpose of this study is to see how the brain re-learns to control the larynx in speaking~     and swallowing when undergoing surgical rehabilitation in the form of either thyroplasty or~     vocal fold augmentation for unilateral vocal cord paralysis. What is needed is information on~     how the brain re-learns to control speaking and swallowing so that we can eventually learn~     how to help patients re-learn faster after their procedure. Functional Magnetic Resonance~     Imaging (or fMRI) will allow us to image your brain as you speak and swallow. We will produce~     brain maps for speaking, swallowing and hand movements.~   "
226140|NCT00597831|"~     The purpose of this study is to determine whether electroconvulsive therapy (ECT) has an~     influence on pressure within the human brain before, during and after ECT.~   "
226141|NCT00597818|"~     The primary purpose of this study is to determine the efficacy and safety of three dose~     levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID.~   "
226142|NCT00597805|"~     The purpose of this study is to learn more about the personal experiences of patients who are~     treated with pelvic exenteration surgery. Pelvic exenteration is a surgical procedure in~     which the pelvic organs including the reproductive organs, bladder and/or rectum are removed.~     We would like to understand more about the physical, emotional, educational, and sexual needs~     of patients who are treated with this surgery. We will use what we learn from this study to~     help find better ways of preparing patients for this type of surgery. This will also allow us~     to be more helpful to patients' needs after surgery.~   "
226143|NCT00597792|"~     The purpose of this study is to collect post-marketing data on patient outcomes and~     satisfaction following treatment with the Plicator™. The outcomes will be tracked through~     analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and~     medication use questionaires will be administered and documented twice before the procedure~     and then again at outlined intervals following the procedure. Additionally, financial~     measures will be evaluated (i.e. pre-procedural and procedural time and costs,~     staffing/personnel needs during procedure, anesthesia and related costs, recovery time and~     associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be~     completed.~      This post-market evaluation is a multi-center study design using the NDO Surgical, Inc.~     Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and~     medication use before and after treatment with the device. Patient follow-ups will be~     completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.~   "
226144|NCT00597779|"~     The purpose of this study is to compare the clinical and radiological outcome of patients~     that are treated with two different orthopedic implants. The study population will consist of~     patients that have sustained unstable hip fractures. The two different implants will be~     randomly assigned.~      The null hypothesis states that there should not be any significant differences between the~     two implants.~   "
226145|NCT00597766|"~     This is a double-blinded study of subacromial corticosteroid injection (steroid injection to~     the shoulder) to treat shoulder pain in the paralyzed (hemiplegic) shoulder of chronic stroke~     survivors. This study is designed to evaluate pain relief of a standard steroid injection~     treatment, compared to a high dose treatment and a low dose treatment, for shoulder pain in~     stroke survivors. A total of 105 chronic stroke survivors with moderate to severe shoulder~     pain will be enrolled. All eligible participants will undergo an initial test injection to~     localize pain to the subacromial space. If this turns out to be positive, the subjects will~     be randomly assigned to one of three groups:~        1. low dose group which receives 20mg of steroid (triamcinolone) injection to the~          subacromial space of the affected shoulder;~        2. standard dose group which receives a standard 40mg of steroid (triamcinolone) injection~          to the subacromial space of the affected shoulder; or~        3. high dose group which receives 60mg of steroid (triamcinolone) injection to the~          subacromial space of the affected shoulder.~      Study participants will all rate their pain in interviews (Baseline, weeks 1, 2, 3, 4, 8, 12~     (7 times) and in laboratory-based measures that will be administered at baseline, weeks 4, 8,~     12 (4 times). Subjects will be followed for a total of 13 weeks.~      The study will thus characterize the dose response of triamcinolone for the treatment of~     hemiplegic shoulder pain.~   "
226146|NCT00597753|"~     The purpose of the study was to evaluate the safety and efficacy of peginesatide in the~     maintenance treatment of anemia in participants on dialysis.~   "
226147|NCT00597740|"~     Purpose of Protocol: The purpose of this study will be to compare the clinical utility of~     Propofol sedation with and without the use of the ICU Sedation Protocol. Patients will be~     treated according to the attending/consulting preference. No attempt will be made to~     influence the patient's routine care and management. The study will compare the average~     hourly infusion rates for the Propofol administration, as well as obtain the nursing staffs~     evaluation regarding the ease of neurological assessment during each 12 hour shift~   "
226148|NCT00597727|"~     The specific aim of this study is to determine if peanut allergen-specific SLIT will cause~     clinical desensitization and tolerance to develop in peanut-allergic young children.~   "
226177|NCT00597337|"~     This study will evaluate the effectiveness of a virtual learning treatment in reducing~     bullying among primary school children in the UK and Germany.~   "
226178|NCT00597324|"~     The study will evaluate the feasibility and safety of radial approach in patients undergoing~     coronary catheterisation without any restrictions based on the results of Allen's test.~   "
226150|NCT00597701|"~     The purpose of this study is determine if subjects with alcohol withdrawal who receive oral~     baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal~     symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with~     alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy~     will experience fewer complications of AWS (as measured by use of additional sedatives,~     restraints, and/or intensive care unit [ICU] admissions) compared with subjects who receive~     placebo plus standard benzodiazepine therapy.~   "
226151|NCT00597688|"~     The purpose of this study is to determine if oral mucosal application of chlorhexidine gel~     will prevent the development of ventilator associated pneumonia in children.~   "
226152|NCT00597675|"~     The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects~     who have peanut allergy less allergic and induce changes in their immune system.~   "
226153|NCT00597662|"~     The purpose of this study is to compare adhesion prophylaxis with~     polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety,~     side effects and usability in addition to gaining early evidence of the effectiveness of~     polylactide-caprolactone-trimethylenecarbonate copolymer.~   "
226154|NCT00597649|"~     This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR~     (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy~     pain due to diabetes in adult outpatients.~   "
226155|NCT00597636|"~     The purpose of this study is to help us better understand the cellular changes that may lead~     to the development of lung cancer. We want to compare people who have never smoked and yet~     have been diagnosed with lung cancer to never smokers who have not developed lung cancer. We~     hope to use the information obtained in this study as the basis for future studies and will~     not regard the results from this study as final.~   "
226156|NCT00597623|"~     Digital osteoarthritis (DO) which affects the interphalangeal joints and the~     Metacarpophalangeal (MCP) of the thumb is a common disease, the prevalence of which increases~     with age (36% of the population aged over 70). Certain forms of DO with clinical~     manifestations involving inflammatory features are particularly refractory to usual~     treatments (analgesics, NSAIDs, braces and local injections). The mechanism of osteoarthritis~     involves two major cytokines: interleukin-1 beta and tumor necrosis factor alpha. TNF alpha~     is particularly involved in the inflammation process.~      The aim of the present study is to study the efficacy of TNF alpha blockers (2 injections of~     adalimumab compared to placebo injections in patients with severe and refractory hand~     osteoarthritis.~      We hope that such new therapeutic option may induce substantial pain relief.~   "
226157|NCT00597610|"~     Traditional transrectal ultrasound (TRUS) is a technique used to help determine the stage of~     rectal cancer. All patients at Memorial Sloan-Kettering Cancer Center with rectal cancer have~     an ultrasound at the beginning of their treatment to accurately determine the depth of~     penetration (how deep into the rectal wall the tumor goes) and lymph node involvement of~     their tumor. This information helps determine the best way to treat the patient's disease.~     Three-dimensional TRUS (3-D TRUS) is a new form of ultrasound that gives us all of the~     information of traditional ultrasound in addition to being able to view the tumor in~     3-dimensions. This image can be stored and analyzed to evaluate the tumor size and volume as~     well as determine the unique shape of the tumor. Chemoradiotherapy before surgery is~     considered standard of care for most rectal cancers.~      Currently, there is no accurate way to determine whether or not the tumor has responded to~     the pre-operative radiation therapy. The purpose of this study is to evaluate the response of~     rectal cancer to pre-operative chemotherapy and/or radiation therapy using 3-D TRUS to~     measure the volume of the tumor before and after chemoradiotherapy.~   "
226158|NCT00597597|"~     The goal of this trial is to determine the activity of erlotinib in a rationally selected~     population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast~     cancer. If erlotinib is shown to have activity, this could identify a form of targeted~     therapy for this specific subset of breast cancer patients. In addition, it may identify a~     subset of breast cancer patients with tumors that overexpress EGFR in whom other EGFR~     targeted therapies could warrant further testing.~   "
226159|NCT00597584|"~     The purpose of this study was to evaluate the safety and efficacy of peginesatide in the~     maintenance treatment of anemia in participants on dialysis.~   "
226160|NCT00597558|"~     The purpose of this study is to determine if children with egg allergy can be desensitized to~     egg protein and if this desensitization can help them outgrow their egg allergy at an earlier~     time than normal. Our hypothesis is that children with egg allergy can be orally desensitized~     to egg protein and that this desensitization will help them outgrow their egg allergy at an~     earlier time than normal.~   "
226161|NCT00597545|"~     The purpose of this study is to determine if we can reduce the incidence of cognitive~     dysfunction — difficulty in performing certain pencil-paper, memory, finger dexterity and~     thinking type of tasks called neuropsychometric tests — in patients with adult onset diabetes~     mellitus (DM) undergoing surgery on the carotid artery (CEA).~      We hypothesize that cognitive dysfunction can be decreased in patients with type II DM by~     augmenting cerebral blood flow with a shunt during carotid endarterectomy compared to~     patients with Type II DM who are treated with conventional management in which a shunt is~     placed only if the electroencephalogram (EEG) indicates cerebral ischemia.~   "
226162|NCT00597532|"~     To Test Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast~     Tissue using a Randomized Placebo Controlled Study.~      Objectives:~        -  To determine (by immunohistochemistry) whether specific cellular markers and gene~          products associated with breast carcinoma can be altered by soy therapy.~        -  To identify genes that can be altered by soy therapy in normal and neoplastic breast~          tissues by unbiased gene expression analysis using microarrays.~        -  To compare specific cellular markers and pathways (immunohistochemistry), and gene~          expression using microarrays in normal and cancerous breast tissue.~   "
226179|NCT00597311|"~     Trial compares two preoperative stage II and III rectal cancer treatment strategies: short~     term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional~     chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.~   "
226510|NCT00592904|"~     The purpose of this study is to evaluate the safety, tolerability and continued efficacy of~     perampanel in patients previously enrolled in double-blind, placebo-controlled studies for~     Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN).~   "
226163|NCT00597519|"~     In this study two cord blood collections will be used to increase the number of cord blood~     cells you will receive on transplant day. We call this a double unit cord blood transplant.~     A previous study suggests double unit cord blood transplant may have a better result. The~     main purpose of this study is to find out how good a cord blood transplant using two cord~     blood collections from two different babies is at curing you of your cancer. Double unit cord~     blood transplants are now being studied as a way to increase the number of cord blood cells~     given to bigger children and adult patients.~      Based on studies that have already been done double unit cord blood transplant appears to be~     safer than if only one cord blood unit is used. However, double unit cord blood transplant is~     a fairly new form of treatment.~   "
226164|NCT00597506|"~     The purpose of this study is to find the safest and most effective dose of the drugs~     bevacizumab and everolimus given in combination for the treatment of metastatic colorectal~     cancer. Bevacizumab (also called Avastin™) is a drug that is given intravenously (through a~     vein). Everolimus (also called RAD001) is a tablet that is taken by mouth.~      Bevacizumab is a protein that is thought to prevent the formation of blood vessels tumors~     need to grow. RAD001 has multiple capabilities, like bevacizumab it may prevent the formation~     of blood vessels needed by tumors and it also may stop tumor growth.~      This study will try to find the safest dose of these drugs that can be tolerated when taken~     in combination. The study will look at how the drugs work in the body, and will see if there~     is any effect on metastatic colorectal cancer.~   "
226165|NCT00597493|"~     PURPOSE AND OBJECTIVES:~      Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide~     in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS.~      Secondary Objectives To evaluate the safety and toxicity of combination therapy using~     Sorafenib plus temozolomide; To determine the pharmacokinetics of Sorafenib when combined~     with temozolomide in patients on and not on concurrent EIAC medications.~   "
226166|NCT00597480|"~     Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height~     during childhood and final height in children born small for gestational age (SGA). Because~     rhGH has been associated with increased insulin levels and insulin resistance, concern has~     been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes~     mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA~     children.~   "
226167|NCT00597467|"~     To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear~     basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.~   "
226168|NCT00597454|"~     The purpose of the research is to examine the usefulness of using patient navigators in~     improving coordination of care between the Breast Examination Center in Harlem (BECH) and the~     Ralph Lauren Center for Cancer Care and Prevention (RLCCCP) for patients with a suspicious~     breast finding. This study will collect information to improve the role of the Patient~     Navigator, nonmedical staff that helps coordinate patient care. The study will also collect~     information to be used to help remove barriers that happen when several different~     institutions provide care.~   "
226169|NCT00597441|"~     The objective of this trial is to assess the toxicity of thymus transplantation following~     unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events~     that are not typically associated with umbilical cord blood transplantation. Also, to~     determine whether engraftment of a third party thymus allograft is feasible in patients who~     have undergone unrelated umbilical cord blood transplantation.~   "
226170|NCT00597428|"~     The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone~     administration in patients with opioid-induced bowel dysfunction (OBD).~   "
226171|NCT00597415|"~     The purpose of this study is to compare the efficacy of celecoxib versus placebo in delaying~     the onset of pain and improving walking function in subjects with knee Osteoarthritis~   "
226172|NCT00597402|"~     Primary objective: To use overall survival to assess the efficacy of the combination of~     radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan~     in the treatment of grade IV malignant glioma patients following surgical resection.~      Secondary objective: To determine the progression-free survival following the combination of~     radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and~     irinotecan.~      Exploratory Objective: To explore the relationship between biomarkers and outcome (overall~     survival and progression-free survival) among patients with grade IV malignant glioma treated~     with radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and~     irinotecan.~      To describe the toxicity of radiation therapy,temozolomide and Avastin followed by Avastin,~     temozolomide, and irinotecan.~   "
226173|NCT00597389|"~     Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to~     receive either propranolol or placebo in a double-blind placebo controlled design. Medication~     was initiated within 12 hours of hospital admission. At 6-weeks, child PTSD symptoms and~     heart rate (HR) during trauma recall were assessed. We hypothesized that participants who~     received propranolol would report fewer PTSD symptoms and have lower heart rates than those~     who received placebo.~   "
226174|NCT00597376|"~     The purpose of this six-month research study is to determine if Cerefolin NAC reduces levels~     of substances in the blood that may be associated with thinking ability and the health of~     brain cells in subjects with memory concerns when compared to a standard multivitamin.~     Cerefolin NAC is available as a dietary supplement via a prescription from a physician. The~     multivitamin used in the study contains the Recommended Daily Intake recommended for older~     persons.~   "
226175|NCT00597363|"~     BACKGROUND. Arterial access site complications remain the most frequent adverse events after~     percutaneous transluminal procedures. We investigated the safety and efficacy of the~     pro-coagulant wound dressing Neptune Pad ® compared to conventional manual compression for~     access site management after peripheral percutaneous interventions.~      METHODS. We enrolled 201 consecutive patients and randomly assigned patients for Neptune Pad~     ® (n=100) vs. conventional manual compression (n=101). Patients were followed clinically~     until hospital discharge and by duplex ultrasound at 24 hours postprocedure for occurrence of~     access site complications. Time-to-hemostasis and time-to-ambulation were recorded, patients´~     and physicians´ discomfort were measured using a visual analogue scale.~   "
226176|NCT00597350|"~     The purpose of this study is to determine if bread containing fenugreek reduces blood sugar~     and insulin compared to identical bread without fenugreek.~   "
226180|NCT00597298|"~     Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery~     of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a~     program of diaphragm muscle training by means of the Threshold variable resistance device~     could improve the rate of complete diaphragm mobility recovery in a shorter time period.~     Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific~     training protocol or to a generic non-training physical activity.~   "
226181|NCT00597285|"~     This study will look for evidence that a virus called HHV-6B may be related to seizures and~     to a form of brain injury called mesial temporal sclerosis that is associated with seizures.~     The study will use new, more sensitive brain scans to try to detect brain regions that might~     be affected by the virus and will examine cerebrospinal fluid (CSF, the fluid that bathes the~     brain and spinal cord) for evidence of the virus as well.~      Healthy volunteers and people with seizures uncontrolled by anti-epileptic drugs who are~     between 18 and 45 years of age may be eligible for this study. Candidates are screened with a~     physical examination and laboratory tests.~      Participants undergo the following procedures:~        -  PET scan. This test uses a radioactive chemical called 18FDG, which is detected by the~          PET scanner to obtain images of the brain. The subject lies on a table with his or her~          head positioned in the scanner. A swimming cap with a small light reflector is placed on~          the head to monitor the position of the head during the scan. A catheter (plastic tube)~          is inserted into an artery at the wrist or elbow crease of the arm for obtaining blood~          samples during the scan, and a second catheter is placed in a vein in the other arm for~          injecting the 18FDG. The scan takes up to 2 hours. A second scan may be done over an~          additional 15 minutes.~        -  MRI. This test uses a strong magnetic field and radio waves to obtain images of the~          brain. The subject lies on a table that can slide in and out of a metal cylinder~          surrounded by a magnetic field. Most scans last between 45 and 90 minutes.~        -  Lumbar puncture. The subject sits upright or lies on a table with the knees curled to~          the chest for this procedure. A local anesthetic is injected to numb the skin and a~          needle is inserted in the space between the bones in the lower back where the CSF~          circulates below the spinal cord. A small amount of fluid is collected through the~          needle.~        -  Blood tests. About 4 tablespoons of blood are drawn for viral tests.~   "
226182|NCT00597272|"~     Vaccines contain substances that help us make antibodies. Different antibodies help protect~     us against a variety of harmful things. GD2 and GD3 gangliosides are substances found on the~     surface of most melanoma cells. They are also occasionally found on some normal cells. Large~     quantities of antibodies called monoclonal antibodies have been prepared in the laboratory~     against GD2 and GD3 and given to patients with metastatic melanoma. In about 10% of cases~     this has resulted in clinically relevant regression of melanomas. These monoclonal antibodies~     are not currently available or used in the clinic but studies in the laboratory indicate that~     vaccines against GD2 and GD3 can be as effective as monoclonal antibodies.~      In this trial we wish to raise the level of antibodies in your blood against GD2 and GD3. We~     will vaccinate you with the modified forms of GD2 called GD2 lactone and GD3 called GD3~     lactone (GD3L), all attached to the antibody booster KLH, and mixed with the immune booster~     (immunologic adjuvant) QS-DG. While over a thousand patients have received vaccines with~     QS-21, the QS-DG used here is synthesized for the first time at MSKCC and is referred to as~     QS-DG rather than QS-21 which is purified from tree bark. QS-21 and QS-DG are, to the best of~     our knowledge chemically identical. It is unknown if using this bivalent vaccine will raise~     the level of antibodies in your blood to either ganglioside. It is unknown if raising the~     level of antibodies in your blood will lower your risk of relapse. This study will check your~     blood for production of antibodies, and check you for side effects.~   "
226183|NCT00597259|"~     Although the best treatment choice for chronic hepatitis B is not clarified yet, certain~     therapeutic concepts could be derived from the experience of treating patients with chronic~     hepatitis C or human immunodeficiency virus (HIV) infection. A major advancement in treating~     hepatitis C or HIV infection has been the development of combination therapy. Whether the~     combination therapy using Peg-IFN alfa-2a plus ETV can achieve a long-term beneficial effect~     against ETV alone is not clarified. A prior single-arm pilot study suggested that similar~     combination therapy may be beneficial in patients with chronic hepatitis B. In this proposal,~     we thus hypothesize that the efficacy by using combination therapy with pegylated IFN alfa-2a~     plus ETV is superior to that by using ETV alone in that Peg-IFN may restore host immunity~     against HBV and prolonged ETV can maximize viral suppression.~      The objective of this clinical trial is to evaluate the efficacy of the combination of~     Peg-IFN alfa-2a at a dose of 180 mcg administered subcutaneously per week and ETV 0.5 mg~     daily for 24 weeks followed by ETV 0.5 mg daily monotherapy for an additional 120 weeks~     versus ETV 0.5 mg daily monotherapy for 144 weeks in patients with HBeAg-positive chronic~     hepatitis B. It will be an open-label, randomized, comparative, multi-center clinical trial.~     The recruited patients will be equally randomized into two treatment groups. Treatment-free~     follow-up period will be 48 weeks in both groups of patients. All subjects will be assessed~     for loss of HBeAg, presence of anti-HBe, loss of HBsAg, presence of anti-HBs, suppression of~     HBV DNA, and normalization of serum ALT at the end of treatment and end of follow-up.~     Genotypic and virologic resistance to ETV will also be assessed at baseline and at end of~     years 1, 2 and 3. The primary efficacy will be HBeAg seroconversion.~   "
226184|NCT00597246|"~     This research protocol makes pictures of brain tumors. The pictures are made with a positron~     emission tomography (PET) scanner. PET scans use radioactivity to see cancer cells. We are~     using a new kind of PET scan. The new PET scan is called [18F]-FACBC PET. We will compare~     this to the standard PET scan. The standard PET scan is called [11C]-methionine PET.~      We expect these pictures will give us information about your tumor. We also hope to collect~     information about the amount of radioactivity exposure. We will measure radioactivity~     exposure to your tumor, brain and other organs. The research study results will be used to~     support the submission of an investigational new drug (IND) application to the Food and Drug~     Administration (FDA).~   "
226185|NCT00597233|"~     This trial is conducted in South America. This aim of this trial is to evaluate the~     comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.~   "
226186|NCT00597220|"~     To demonstrate that in patients with persistent atrial fibrillation who had recovered normal~     sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily~     of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus~     rhythm at one year of follow up.~   "
226187|NCT00597207|"~     During resuscitation of out of hospital cardiac arrest patients the use of a mechanical chest~     compression device Autopulse will improve survival compared to manual compressions.~   "
226188|NCT00597194|"~     We compare laparoscopic and classic open operation for inguinal hernia in children. Attention~     is focused on the recovery, surgical result and the duration of the operation and hospital~     stay.~   "
226189|NCT00597181|"~     The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less~     post-operative inflammation than trabeculectomy with mitomycin c.~   "
226193|NCT00597116|"~     A clinical study to assess if a new investigational drug is effective in treating malignant~     mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients~     will be assigned by chance to receive either the new drug or a chemotherapy treatment~     (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient~     wishes to continue in the study. The study will recruit approximately 66 patients.~   "
226194|NCT00597103|"~     This study will evaluate the effects of more frequent dialysis on cognitive function~     including the assessment of sleep apnea and restless legs. Our hypothesis is that more~     frequent dialysis improves cognitive function and may have important implications on clinical~     care of ESRD patients and help to emphasize the need for treatments that will allow patients~     to live with dialysis rather than live for dialysis.~   "
226195|NCT00597090|"~     The purpose of this study is to better understand genetic susceptibility to infections and~     the interactions of specific genetic polymorphisms of innate immune receptors with microbial~     and fungal organisms.~      The goals of this study are:~        1. Find out if some people are more likely to get severe infections, than others. To do~          this we will compare patients with leukemia who develop severe infections to patients~          who do not develop infections.~        2. Find out if some people are more likely to develop lymphoma than others. To do this we~          will compare patients with lymphoma to people without lymphoma who are of the same sex~          and similar age and ethnic background to the patients with lymphoma.~   "
226196|NCT00597077|"~     Heart failure is a clinical syndrome where the heart is unable to pump enough blood to~     satisfy the organism's metabolic needs. Heart failure has become a major clinical and public~     health problem with approximately 300,000 Canadians being affected. Atrial fibrillation is a~     rhythm disorder in which the upper chambers of the heart (the atria) are paralyzed by~     continuous electrical activity. Some of the continuous chaotic electrical activity in the~     atria travels to the lower cavities of the heart (the ventricles) causing then to beat~     irregularly and very rapidly. It is the most frequent cardiac arrhythmia, affecting 5% of~     individuals 65 years and older and it is associated with an increased risk of stroke. Both~     conditions (heart failure and atrial fibrillation) often co-exist in the same patient. Heart~     failure promotes atrial fibrillation and atrial fibrillation aggravates heart failure. The~     Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is investigating whether~     preservation of normal cardiac rhythm influences mortality and morbidity. The AF-CHF study~     began in 2001 and 1,378 patients have been enrolled from 123 participating centres, in North~     America, South America, Europe, and Israel. The results of this trial which are expected in~     October 2007, will improve decision-making for the physician and will provide useful~     information to healthcare organizations responsible for the care of heart failure patients.~   "
226197|NCT00597064|"~     The goals of control status of asthma have been changed with the improvement of its~     management as a chronic disease; many steps should be taken to achieve asthma control as~     defined by the GINA/NIH guidelines. There are good results with single variables, but overall~     asthma control should be addressed in different ways. Most traditional clinical studies~     provide an incomplete assessment of disease control, despite good clinical practice. The~     association of inhaled corticosteroid (IC) and long-action beta 2 agonist (LABA) has already~     showed their efficacy to reduce asthma symptoms, exacerbations and cost for moderate and~     severe asthma patients as well as the improvement in their quality of life. On the other~     hand, even with the use of first line maintenance medication, as recommended by guidelines,~     some asthmatic patients fail in obtaining a total control of the disease. This lack of~     efficacy, led us to hypothesize, that these patients who fail in response, would present~     chronic and fixed airway obstruction as a consequence of persistent inflammation and airway~     remodeling. This study has the purpose of looking for an adequate composite measure to~     provide an indicator of overall asthma status more accurately and meaningfully as reflect of~     treatment effectiveness and disease control. For this, we will test by a randomized control~     trial if an additional oral corticosteroid treatment could modify spirometric and~     plethysmography values, nasal and low airway cytology and HRCT (to evaluate small airway) in~     regularly treated stable asthma patients who have a positive bronchodilator response.~   "
226198|NCT00597051|"~     The purpose of this study is to determine which dose, if any, results in testosterone levels~     within the normal range for men.~   "
226199|NCT00597038|"~     The purpose of this study is to:~      Phase I Objectives:~        -  Find the most tolerated dose to use for Phase II~        -  Collect information on how the body responds to this combination of study drug~      Phase II Objectives:~        -  To determine the overall response of participants using this combination of study drug~      The expression of proto-oncogene tyrosine-protein kinase (Src), a substance present in a~     significant proportion of melanomas plays a role in the growth, multiplying, and dividing of~     cancer cells. Melanoma cells appear to be sensitive to these agents that block the action of~     Src in concentrations that can be achieved in patients. We suggest that Src inhibitors (such~     as Dasatinib) may be a good choice for treatment of melanoma in combination with Dacarbazine~     (a chemotherapy drug that can cause the shrinkage of melanomas). We wish to to evaluate the~     Src inhibitor Dasatinib in combination with the chemotherapy drug Dacarbazine. The novel oral~     Src inhibitor Dasatinib may be able to increase the effectiveness of chemotherapy for~     melanoma compared to chemotherapy alone. Dacarbazine is a standard treatment for melanoma~     currently. The effectiveness of this chemotherapy drug may be increased by combination with~     Dasatinib. Dacarbazine has been approved by the US Food and Drug Administration (FDA) for~     treating melanoma; Dasatinib has been approved by the FDA to treat leukemia, but it has not~     been approved alone or in combination with Dacarbazine to treat melanoma.~   "
226200|NCT00597025|"~     This study is to evaluate the impact of providing high protein supplementation in the form of~     a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.~   "
226201|NCT00597012|"~     There are two cartilage structures, called menisci, in each knee joint. A torn meniscus can~     be caused by a traumatic injury or aging-related degeneration. Osteoarthritis (OA) is a type~     of arthritis that is caused by the breakdown and eventual loss of another type of cartilage~     that covers the end of bones within a joint. In people who have knee OA, a meniscal tear can~     easily lead to disability. This study will compare the effectiveness of two recommended~     treatments, surgery and physical therapy, for people with a torn meniscus and knee OA.~   "
226511|NCT00592891|"~     Hypothesis: That HBOT can be toxic in the low-pressure range.~   "
226202|NCT00596999|"~     To investigate the safety of partially matched related human placental-derived stem cells~     (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same~     donor in subjects with various malignant or nonmalignant disorders potentially curable with~     stem cell transplantation and to assess potential restoration of normal hematopoiesis and~     immune function in subjects with these disorders~   "
226203|NCT00596986|"~     The purpose of this study is to determine how psychotherapy and pharmacotherapy respectively~     change brain activity in patients suffering from chronic depression.~   "
226204|NCT00596973|"~     The aim of this study is to assess the short term success and feasibility of ileal~     transposition with sleeve gastrectomy in non-morbidly obese patients with poorly controlled~     Type 2 Diabetes Mellitus~   "
226205|NCT00596960|"~     The purpose of this study is to determine whether motivational enhancement therapy (MET)~     reduces alcohol use in a population of HCV-infected veterans who are currently drinking~     alcohol and have alcohol disorders. We hypothesize that veterans with HCV, an alcohol use~     disorder and continued excessive alcohol use who receive MET will have a greater reduction in~     the number of standard alcohol drinks per week and a greater percentage of days abstinent~     than veterans who receive health education control intervention.~   "
226206|NCT00596947|"~     The purpose of the study was to determine if rapid discontinuation of corticosteroids (also~     known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus)~     and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte~     globulin) will give similar safety and efficacy results compared to continuation of~     corticosteroids (also known as prednisone maintenance) and standard maintenance~     immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using~     Thymoglobulin (Rabbit antithymocyte globulin).~   "
226207|NCT00596934|"~     Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the~     liver and development of scarring. This condition occurs more frequently in overweight and~     obese persons. It is often associated with resistance to the actions of insulin hormone. Fat~     cells secrete a hormone called leptin. Recently, we have learned that obese or overweight~     persons make too much leptin, which may contribute to insulin resistance. Paradoxically,~     patients who do not have any fat cells, also have insulin resistance. In these patients,~     insulin resistance is caused by the absence of leptin and leptin replacement significantly~     improves insulin resistance and fat deposition in the liver. In an earlier study, we~     determined the leptin levels in patients with NASH and how these levels are related to body~     fat levels as well as responsiveness to insulin. We saw that a subgroup of patients with NASH~     have relatively low levels of leptin in contrast to the amount of body fat they had. We now~     would like to see if restoring leptin levels to normal will improve the disease process in~     these patients. Our study patients will be male patients, aged between 18 and 65 (inclusive),~     who do not have any other cause for their liver disease. We have put some restrictions in~     body size such that a spectrum of patients from normal weight to obese range would be~     included. They will also demonstrate low leptin levels (levels similar to only 25% of normal~     population). We will use a genetically engineered form of leptin manufactured by Amylin Inc.~     given via injections under the skin. We plan to continue therapy for a period of one year and~     evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic~     parameters and body composition characteristics that we examined in our earlier study. We~     expect that patients with low blood leptin levels will show improvement in their liver~     disease and insulin resistance when their blood leptin levels are restored to normal.~   "
226208|NCT00596921|"~     This study proposes to examine the correlation of central venous pressure to measures of the~     diameter of the inferior vena cava as determined by bedside ultrasonography.~   "
226209|NCT00596908|"~     This study is designed to obtain an imaging training set that will be used to evaluate images~     in future trials. Currently, no radiopharmaceutical diagnostic imaging agent has been~     approved by the FDA in the U.S. for use in diagnosing Parkinson disease and related~     Parkinsonian syndromes. The diagnosis of Parkinsonian syndromes in the U.S. is based on~     clinical criteria only. The goal is to demonstrate that 123I-ALTROPANE® paired with SPECT~     imaging permits a more accurate early diagnosis of Parkinson disease than a clinical~     diagnosis by a general neurologist.~   "
226210|NCT00596895|"~     Primary Outcome Measures:~      Decrease in rate of serum PSA rise~      Secondary Outcome Measures:~      Adherence to treatment regimens~      Quality of life as assessed by FACT-P at baseline and at 12 months of treatment~      Modulation of serum testosterone,isoflavone metabolites, and cholesterol~      Estimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date:~     February 2007 (Final data collection date for primary outcome measure)~   "
226211|NCT00596882|"~     The proposed study has been designed to examine the effect of a message that primes genetic~     susceptibility on actual enrollment in a smoking cessation program, actual response to~     smoking cessation treatment, and potential moderators and mediators of this effect.~   "
226212|NCT00596856|"~     Purpose:~        1. Revise the existing oral health risk assessment tool (known as the Encounter Form in the~          IRB-approved project DENT-1527) and develop accompanying guidelines for its use and~          distribution.~        2. Evaluate the education intervention to accompany the distribution of the new risk~          assessment tool - the Priority Oral Health Risk Assessment and Referral Tool - PORRT and~          guidelines.~        3. Evaluate the extent to which the education intervention affects physicians' screening~          and referral performance (use of guidelines, appropriateness and quality of referrals).~      Participants: Primary care medical and dental providers in North Carolina.~      Procedures (methods): UNC will engage in a systematic literature review of dental caries risk~     and a simulation analysis in order to finalize the design of the PORRT referral tool and its~     accompanying guidelines. Medical providers will be surveyed statewide regarding their oral~     health screening practices with children under three years of age, and a randomized~     controlled trial will be implemented in 75 of these practices to evaluate guideline~     dissemination and effectiveness. Referral behavior will be evaluated through an analysis of~     the completed PORRT forms and a record review in dental practices serving as referral sites.~     Medicaid claims analysis will determine referral effectiveness for the RCT sites compared to~     the state as a whole.~   "
226213|NCT00596843|"~     The purpose of this study is to determine if a 6-session motivational interviewing~     intervention is more effective than a 6-session educational intervention at reducing~     behaviors that may lead to infection, transmission, and progression of HIV and hepatitis C~     among out of treatment injecting drug users.~   "
226214|NCT00596830|"~     Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin~     prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or~     metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.~   "
226215|NCT00596817|"~     This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major~     depressive episodes in patients who responded to open-label treatment with Vortioxetine.~   "
226220|NCT00596752|"~     The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on~     the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency~     and height of major amputations in patients suffering from PAOD stage IV.~   "
226221|NCT00596739|"~     A correlation between obesity and male fertility has been observed in a few clinical studies.~     Normal weight men appear to have higher sperm concentrations and sperm motility when compared~     to obese men, suggesting that weight loss might improve sperm function. However, there also~     are reported cases of severe male factor infertility following weight loss surgery in~     previously fertile men. The aim of this study is to determine if there are differences in the~     semen analyses and hormone levels of men obtained before and after undergoing weight loss~     (bariatric) surgery.~      This will direct future research and treatment.~   "
226222|NCT00596726|"~     To demonstrate that that the device is safe and potentially efficacious for use as a left~     ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support~     post weaning from cardiopulmonary bypass.~   "
226223|NCT00596713|"~     Sleep disturbances are of great relevance within the context of public health as they affect~     a sizable portion of the population with far reaching consequences. Many automobile and labor~     accidents as well as poor school and work performance can be traced to sleep disturbances,~     which are also linked to cardiovascular disease, metabolic syndrome, and psycho-cognitive~     alterations.~      OBJECTIVES:~        1. Establish the epidemiologic profile of sleep disturbances among the adult population of~          the city of Sao Paulo in 2007;~        2. Investigate associations between sleep patterns and disturbances in that population,~          taking into account the following variables: social-demographic status, anthropometrics,~          clinical, activity/rest cycle, eating and physical activity habits, mood disturbances,~          sexual dysfunction in males, alcoholism, drug addiction, genetic markers, biochemical,~          hematological, endocrine, immunologic and inflammatory indicators;~        3. assess the compatibility of the results collected in the current study with those of~          epidemiologic sleep investigations of said city carried out in 1987 and 1995 with the~          aim of determining the secular sleep disturbance trend.~      METHODS:~      The two-stage cluster randomized sample included 1100 individuals of the city of Sao Paulo,~     representing the population proportionally to gender, age groups and social classes. Data~     were amassed as follows:~        1. the application of home and institution questionnaires;~        2. description of the sleep patterns and disturbances through polysomnography and~          actigraphy, performed at the Sleep Institute;~        3. collection of peripheral blood for biochemical, hematologic, endocrine and genetic~          assays.~      STATISTICS:~      Subsequent to double typing (inputting) and analysis of data consistency, descriptive and~     analytical statistical assessments will be performed with the aim of describing patterns of~     sleep disturbances associated to the explanatory variables under investigation. In the light~     of bi-varied analysis, predictive/explanatory multivaried models were adjusted.~   "
226224|NCT00596700|"~     The Study~        1. Prospective trial of the Niv score validating score against known activity indices - see~          addendum A for Niv score~        2. Known Crohn's disease patients undergoing capsule endoscopy are identified - see~          addendum B for inclusion/exclusion criteria~        3. Prior to capsule exam, temperature is taken, height and weight measured, bloods are~          drawn for albumin, ESR, HCT, CRP~        4. Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for~          questionnaire~        5. Capsule exam is performed~        6. CD of de-identified is made at the study site.~        7. Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled~          on thumbnails~        8. CDs are copied~        9. CDs of study patients are provided to blinded readers~   "
226225|NCT00596687|"~     High blood glucose levels in surgical patients with diabetes are associated with increased~     risk of medical complications and death. Improved glucose control with insulin injections may~     improve clinical outcome and prevent some of the hospital complications. In patients who have~     undergone surgery, high blood glucose increases the risk of wound infection, kidney failure~     and death. It is not known; however, what is the best insulin regimen in patients who will~     undergo surgery. The use of repeated injections of regular insulin is commonly used for~     glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus®~     and Apidra® insulins has been shown to improve glucose control with lower rate of~     hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted~     to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental~     glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital~     complications than treatment with regular insulin per sliding scale (SSRI). The present study~     aims to determine which insulin treatment is best for glucose control in hospitalized~     patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment~     of patients with diabetes by the FDA.~      Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial~     Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta,~     Georgia. A total of ~94 patients will be recruited at each institution.~      A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial~     will be completed in order to determine differences in hospitalization cost between basal~     bolus insulin and SSI regimen.~   "
226226|NCT00596674|"~     Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a~     wide variety of disease-related, intrapersonal, and environmental demands to maintain their~     health and quality of life. Engaging in health-promoting behaviors is one strategy~     recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The~     purpose of this four-year study is to refine and test a theoretically and empirically based~     intervention to promote the health and well being of women with the chronic disabling~     condition of fibromyalgia. We hypothesize that women who participate in the Lifestyle~     Counts Intervention will report more greater self-efficacy for health behaviors, more~     frequent health behaviors and more positive health and quality of life than women in the~     comparison group.~   "
226227|NCT00596661|"~     The primary objective of the trial is to demonstrate the safety and feasibility of treating~     coronary artery lesions which have not been previously treated with the TRIMAXX Coronary~     stent system as compared to the reported results for commercially available non-drug eluting~     coronary stent systems which are indicated for the same treatments.~   "
226228|NCT00596648|"~     In Phase 1 of this study, the purpose is to evaluate the safety, tolerability, and highest~     safe dose of the multiple receptor tyrosine kinase inhibitor (including VEGFR2, MET, and RET)~     XL184 in combination with the EGFR inhibitor erlotinib administered to adults with~     Non-Small-Cell Lung Cancer (NSCLC). In Phase 2 of this study, the purpose is to evaluate the~     objective response rate of daily oral administration of XL184 with or without erlotinib in~     subjects with NSCLC who have progressed after responding to treatment with erlotinib.~   "
226250|NCT00596362|"~     The purpose of this study is to test the safety and effectiveness of Avastin introduced into~     the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye).~     Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.~   "
226229|NCT00596635|"~     Urinary tract infections (UTIs) affect over 7 million men and women per year and cost the~     health care industry over 1 billion dollars annually. The incidence of UTI increases markedly~     in elderly institutionalized persons and leads to excessive antimicrobial usage, emergency~     room visits, hospitalization, sepsis, and death. The use of antimicrobials to prevent UTI in~     elderly nursing home patients is not recommended and is fraught with problems such as adverse~     reactions, drug interactions, and the development of drug-resistant organisms. There is no~     accepted method of preventing UTI in residents of nursing homes, a vulnerable and~     understudied population with significant morbidity from UTI.~      The overall goal of this proposal is to conduct a prospective cohort pilot study that~     evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each~     of the aims is critical for the optimal design of a larger placebo-controlled, definitive~     trial of cranberry for prevention of UTI in nursing home residents and will provide the~     essential preliminary data for future larger studies.~   "
226230|NCT00596622|"~     This study will assess the effects of bipolar disorder on brain activity and will determine~     if medication changes the brain activity in people with bipolar disorder.~   "
226231|NCT00596609|"~     Patients undergoing posterior spinal fusion (PSF) procedures for scoliosis are at risk for~     iatrogenic neurologic injury of the spinal cord and/or spinal nerve roots during surgical~     correction of the abnormal spinal curvature. The degree of neurologic injury can range from~     minor sensory deficits to complete paraplegia. Surgeons at CHOP utilize neurophysiologists to~     identify impending neurologic injury. These consultants monitor spinal cord pathways by~     recording and analyzing evoked potentials during the operation. Evoked potentials are low~     voltage electrical signals generated in response to transcranial or transcutaneous electrical~     stimulation of motor and sensory neural pathways.~      Some patients undergoing PSF receive an injection of morphine into the cerebrospinal fluid~     during the operation. This intrathecal (IT) morphine has potent analgesic effects. While most~     commonly used anesthetic agents have well-characterized effects on evoked potentials, little~     data exists on the effects of IT morphine on transcranial electric motor-evoked potentials~     (TceMEPs).~      This is a prospective observational study to characterize the effects of IT morphine on~     TceMEPs.~   "
226232|NCT00596596|"~     The purpose of the study is to determine whether prucalopride is safe and effective in~     patients with chronic idiopathic constipation.~      Hypothesis:~      At all doses administered prucalopride given once daily for 4 weeks is safe and well~     tolerated in patients with chronic idiopathic constipation.~   "
226233|NCT00596583|"~     The primary objective of this study is to test the hypothesis that DYME is safe and effective~     as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining~     the anterior capsule. Secondary objectives are to compare the safety and effectiveness of~     DYME to that of a smaller dose of the same API.~   "
226234|NCT00596570|"~     Treatment of patients suffering from atrial fibrillation pose problems when percutaneous~     coronary intervention with stent implantation (PCI-S) is performed. In the absence of solid~     evidence-based data, no definite recommendations for the management of this patient subset~     are currently given in the guidelines on percutaneous coronary intervention issued by the~     most prominent Cardiology Associations. The management of the antithrombotic treatment before~     invasive cardiac procedures is also incompletely defined. In this study we aim to determine~     in patients with atrial fibrillation undergoing PCI-S:~        1. the contemporary antithrombotic management;~        2. the relative safety and efficacy of the various post-PCI antithrombotic regimens;~        3. the safety and efficacy of drug-eluting stents (DES), bare-metal stents (BMS), and~          bioactive stents (BAS);~        4. the safety of various periprocedural antithrombotic strategies including glycoprotein~          IIb/IIIa inhibitors and bivalirudin;~        5. safety and efficacy of radial vs femoral approach.~   "
226235|NCT00596557|"~     The different mechanisms of action of Everolimus and cyclosporine suppress immune function in~     synergistic manner. Thus it is postulated that the use of Everolimus in combination with~     cyclosporine permits a significant cyclosporine dose reduction without loss of~     immunosuppressive activity in the clinical setting.~      The aim of the present study is to evaluate the evolution of renal function after initiation~     of Everolimus and minimalisation of CNI dose.~   "
226236|NCT00596544|"~     The purpose of this study is to help us learn more about sexual problems after treatment for~     ovarian cancer. At this time, we do not know how many women have sexual problems after they~     are treated for ovarian cancer.~      How common are sexual problems after treatment for ovarian cancer?~        -  What factors make women more likely to have sexual problems after treatment for ovarian~          cancer?~        -  What happens to sexual functioning over the first 12 months after treatment? ie.~      Does it get better or worse?~      • Does referral to a specialized sexual health clinic help?~   "
226237|NCT00596531|"~     The objective of this project is to determine whether acamprosate is more effective at~     providing relief for tinnitus than a placebo.~      Acamprosate has been suggested to be effective in reducing tinnitus annoyance in a~     preliminary study. Study evidence indicates that tinnitus is related to increased excitatory~     spontaneous brain activities. Acamprosate may help restore the excitatory/inhibitory balance~     in the brain and thus reduce tinnitus.~      The current study includes three phases. The first phase is an open-label screening study~     used to identify tinnitus subjects responding to acamprosate. These responding subjects will~     enter the second phase, which is a double blind, placebo-controlled study aimed at confirming~     the subjects' responses to acamprosate. In the third phase, clinical parameters of both~     responders and non-responders will be compared using a multi-linear regression model to~     determine characteristics that define the sub-group of tinnitus patients that are likely to~     benefit from acamprosate treatment. Participation in the study requires that individuals come~     to Portland, Oregon at least 6 times over 16 months for evaluation and data collection.~   "
226238|NCT00596518|"~     The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down~     and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects~     receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate~     of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200~     in subjects with various degrees of kidney function or undergoing chronic hemodialysis will~     be assessed.~   "
226312|NCT00595543|"~     To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5%~     ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.~   "
226239|NCT00596505|"~     Treatment of severe proliferative diabetic retinopathy (PDR) may require the use of silicone~     oil for long-term retinal tamponade to prevent recurrent retinal detachment. Massive bleeding~     during surgery before proper release of traction and peri-silicone oil proliferation after~     surgery were major causes of surgical failure. The likelihood of reproliferation rises in the~     presence of significant preretinal blood. It is therefore crucial to reduce intraoperative~     and postoperative preretinal hemorrhage in complicated diabetic vitrectomy with silicone oil~     infusion.~      Intravitreal avastin has been noted to induce rapid regression of retinal and iris~     neovascularization in proliferative diabetic retinopathy. Further, presurgical administration~     of intravitreal avastin may reduce intraoperative bleeding during membrane dissection in PDR~     with traction retinal detachment. The pretreatment of avastin may be particularly beneficial~     in the treatment of severe active fibrovascular proliferation by decreasing the severity of~     intraoperative and postoperative intraocular hemorrhage, leading to better surgical outcome~     and early visual rehabilitation.~      We conduct a prospective study to evaluate the effect of avastin on the severity of intra-~     and post-operative bleeding, frequency of recurrent bleeding, and anatomical and functional~     outcome in eyes with severe active PDR undergoing vitrectomy with silicone oil infusion.~   "
226240|NCT00596492|"~     The primary objective of this study is to test the hypothesis that DYME is safe and effective~     as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining~     the anterior capsule. Secondary objectives are to compare the safety and effectiveness of~     DYME to that of a smaller dose of the same API.~   "
226241|NCT00596479|"~     The purpose of this study in humans with stable coronary artery disease (CAD) treatable by~     PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of~     subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF~     (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.~   "
226242|NCT00596466|"~     This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when~     administered by itself (without any other anti-epileptic medication) to epilepsy patients for~     the treatment of partial seizures. This is an extension study to a previous clinical trial.~   "
226243|NCT00596453|"~     Ciprofloxacin hydrochloride has been approved by the Food and Drug Administration (FDA) for~     the treatment of mild to moderate infections, including prostate infections. It has been~     suggested that antibiotic treatment influences PSA levels due to the fact that an increase in~     PSA levels may be caused by inflammation or swelling of the prostate. Antibiotics are used to~     treat such inflammatory conditions. However, it has not been proven that antibiotics can be~     used to lower PSA. This research is being done to see if treatment with the antibiotic~     Ciprofloxacin hydrochloride affects the Prostate-Specific Antigen (PSA) blood test. This~     study may also help doctors in deciding which patients need a prostate biopsy.~   "
226244|NCT00596440|"~     A teachable moment (TM) refers to life events or transitions, such as physician visits, early~     detection screening feedback, pregnancy, and hospitalization for, and diagnosis of, disease,~     that inspire health behavior change. Despite strong intuitive appeal of the TM concept and~     over 150 studies of interventions implemented in a TM, there has been little investigation of~     the influence of TMs for smoking, particularly for promoting smoking cessation among those~     indirectly affected by a TM (e.g., relatives of cancer patients). This prospective~     observational study using a matched-group design will assess whether a lung cancer diagnosis~     increases enrollment in a smoking cessation program and cessation, and reduces smoking, among~     the patient's relatives/spouse who smoke. We will compare enrollment in a cessation program~     and cessation and smoking rates in 2 groups of smokers: 1) relatives/spouses of~     newly-diagnosed lung cancer patients, and 2) relatives/spouses of patients with an orthopedic~     condition. We will also explore mediators and moderators of a lung cancer diagnosis as a TM.~     This study could clarify the TM concept for smoking cessation, shed light on the underlying~     mechanisms of TMs, and guide future development and implementation of TM-based smoking~     cessation interventions.~   "
226245|NCT00596427|"~     The mechanism by which colesevelam HCl lowers glucose is not known. Knowledge of the~     potential mechanism of action is important for defining the role of the drug among oral~     antidiabetic agents available for use in subjects with diabetes. The objective of this study~     is to provide insight into the mechanisms of action of colesevelam HCl in T2DM. The~     mechanisms of interest include hepatic insulin sensitivity, rate of appearance of exogenous~     glucose and changes in incretin hormone concentrations.~   "
226246|NCT00596414|"~     Transjugular liver catheterisation allows the measurement of hepatic venous pressure gradient~     (HVPG) and the sampling of liver tissue but patient's tolerance to the procedure is unknown.~     The aim of this study was to assess tolerance to transjugular hepatic liver biopsy with or~     without conscious sedation/analgesia.~   "
226247|NCT00596401|"~     Recently, the preventive effect of Helicobacter pylori (Hp) eradication treatment on the~     incidence of gastric cancer has been reported. By Hp eradication treatment being performed~     for Hp-infected people in Iijima town, we will evaluate whether the incidence of gastric~     cancer and/or the medical care cost can be reduced as compared with those in the previous~     years.~   "
226248|NCT00596388|"~     Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD~     patient to use the HMP device.~   "
226249|NCT00596375|"~     In Emergency Departments (ED) across the nation there is renewed interest in finding ways to~     alleviate the pain and discomfort associated with many of the procedures that children must~     undergo. In a policy by the American Academy of Pediatrics, a nationally recognized advocate~     for children, physicians are urged to advocate for child-specific research in pain management~     and the effective use of pain medication to ensure compassionate and competent management of~     pain. (AAP Statement, 2001) Pediatric urethral catheterizations are one such procedure in~     which children experience significant pain.(11) In present care, children over 2 months of~     age do not routinely receive intervention for urethral catheterization related anxiety and~     pain, and, anecdotal reports suggest that most require physical restraint to complete the~     procedure. Lidocaine is an anesthetic agent that provides relief from pain during many~     commonly performed ED procedures. Intraurethral Lidocaine has been shown to decrease pain~     associated with urethral catheter placement in cystograms, however, Lidocaine is not~     routinely used for urethral catheterizations in the CHOA ED.~      This study aims to investigate the potential use of Lidocaine as an anesthetic agent during~     urethral catheterization of children. Recently, two specific studies were performed~     investigating the use of Lidocaine to decrease discomfort associated with urethral~     catheterization. Using the strengths of both previously published studies, our study will use~     Lidocaine both topically and instilled into the urethra. Investigators plan to perform a~     prospective three-arm double-blinded randomized clinical trial investigating the~     effectiveness of Lidocaine jelly as a analgesic when used as a lubricant for urinary~     catheterization. Investigators aim to demonstrate that Lidocaine used as a lubricant~     anesthetic for urethral catheterization will provide a safe, time-efficient, and relatively~     easy way to decrease pediatric pain in the emergency department setting.~   "
226251|NCT00596349|"~     The purpose of this study is to help us learn more about how women who have had or now have~     ovarian cancer are doing 5 years or more from their diagnosis. We want to learn about general~     quality of life, long-term side effects of treatment, sexual function, thinking, memory, and~     psychological effects (such as anxiety and depression). We will also look at how these women~     are being followed for ovarian cancer. We hope this study will help us better understand how~     women surviving ovarian cancer are doing.~   "
226252|NCT00596336|"~     The purpose of the study is to determine whether it is possible to improve the immune~     response rate to 'flu vaccination in patients with chronic lymphocytic leukaemia (CLL).~      Annual flu vaccination is recommended for all patients with CLL because they are known to be~     susceptible to infections and particularly to chest infections that may occur as a~     complication of influenza. Protection against 'flu depends on patients having a high level of~     antibodies against the 'flu virus. Vaccination works by stimulating the immune system and~     thus boosting the levels of these protective antibodies.~      CLL patients have weakened immune systems due to the leukaemia itself but also following~     chemotherapy. The exact cause of these immune defects is not known. However, CLL patients~     typically have low antibody levels and their immune cells may not work normally.~      Unfortunately, studies have shown that patients with CLL are not very good at making~     antibodies to 'flu vaccination and as a result protection against flu is not very reliable.~     Recent studies have shown that only 15-20 % of CLL patients will achieve a protective~     antibody level.~      Recently a new type of medical cream has been introduced to treat certain skin conditions.~     Its name is Imiquimod and it is licensed to treat viral warts in the genital area and a type~     of skin cancer called basal cell carcinoma. It works by increasing the immune response in the~     skin. Animal studies have shown that as well as increasing immunity against viruses and~     cancers, it increases responses to vaccination when applied at the site of vaccination.~      In this study we propose to test whether this new medicine can improve the response to the~     'flu jab.~   "
226253|NCT00596323|"~     The researchers' long-term goal is to develop a small implantable device that can continually~     monitor glucose levels. This will be an antenna. Changes in the glucose levels in will affect~     the antenna signals and those can be used to predict the patient's glucose levels.~   "
226254|NCT00596310|"~     Lung cancer is the number one cancer killer in Kentucky and has a very high incidence within~     the 5th Congressional District of Kentucky (110.8 cases per 100,000 in period 1996-2000).~     Surgical removal provides the best chance for cure. Unfortunately, the majority of lung~     cancer cases are detected in an advanced stage, when surgical resection is impossible. This~     leads to shorter survival rates and increased mortality rates for lung cancer, increased~     patient suffering, and greater cost to the healthcare system. Methods that favor earlier~     detection are therefore crucial for successful treatment. One such method, low-dose spiral~     computed tomography (CT) is being studied to determine whether its use as a screening method~     will lead to earlier detection and earlier intervention, perhaps impacting survival and~     mortality in lung cancer. This method has a modest sensitivity to detect lung cancer, but low~     specificity, which leads to many false positives and a low negative predictive value. The~     present study is designed to address both of these limitations by: 1) identifying individuals~     in the population at highest risk for developing lung cancer (due to smoking habits and~     decreased pulmonary function) for subsequent CT screening, and 2) performing biomarker~     testing in conjunction with the CT scan to improve the ability to discern individuals with~     benign lung nodules from those with malignant tumors. The 5th Congressional District of~     Kentucky has one of the highest rates of lung cancer in the nation and is an ideal location~     to test the validity (sensitivity and specificity), feasibility (negative and positive~     predictive value), and efficacy (stage distribution shift to earlier stage disease, increased~     survival, and decreased cancer-specific mortality) of these strategies to enhance early~     detection.~   "
226255|NCT00596297|"~     The purpose of this study is to determine whether preoperative intravitreal bevacizumab is~     effective in reducing intra-operative and postoperative bleeding in diabetic patients~     submitted to pars plana vitrectomy for vitreous hemorrhage.~   "
226256|NCT00596284|"~     This study will evaluate the effectiveness of cognitive behavioral therapy in treating~     anxiety in older adults with dementia.~   "
226257|NCT00596271|"~     The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51~     (JE-PIV) single and concomitant with HAVRIX® 1440~   "
226258|NCT00596258|"~     A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous~     cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the~     safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.~   "
226259|NCT00596245|"~     This is an open-label, parallel group, single-center study. The study design consists of a~     screening and a treatment period. A total of 42 (approximately 21 of each sex) non-smoking~     healthy volunteers aged 18 - 35.~   "
226260|NCT00596232|"~     The purpose of this study is to investigate how mucus (phlegm or spit) is broken down once it~     forms in the airways (bronchial tubes) of people with lung disease. This research study will~     also examine whether blood groups have an effect on lung function or the type of mucus found~     in the lung. This study is not designed to be a treatment for asthma, emphysema, cystic~     fibrosis, or other lung disease. It is designed to help the investigators learn more about~     the causes of airway disease.~   "
226261|NCT00596219|"~     The purpose of this study is to better understand how to use celecoxib, a popular drug widely~     used for arthritis, for head and neck cancer patients. Some doctors believe that celecoxib~     may have helpful effects when used for head and neck cancer. Celecoxib has been shown to~     prevent some cancers in animals. It has also been used to make standard chemotherapy and~     radiation work better in both animals and humans. However, all of the previous studies~     focused on tumors outside the head and neck region. To better understand how to use celecoxib~     for head and neck cancer patients, doctors at MSKCC are studying the effects of the drug on~     certain chemicals in the body that are thought to be important for cancer treatment.~      This study aims to measure how celecoxib affects those chemicals, which can be found in the~     tumor, blood, and urine of patients with head and neck cancer. Although celecoxib is already~     used to treat arthritis, this study will be the first to test the drug in head and neck~     cancer patients.~   "
229185|NCT00557011|"~     The purpose of this study is to assess, in a controlled environment, the efficacy and safety~     of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.~   "
226262|NCT00596206|"~     To assess the efficacy response rate at 3-months of two dosing regimen of leflunomide in~     DMARDs-naive patients presenting an early-RA using American College of Rheumatology 20%~     response rate.~      To assess the clinical efficacy at 1-month and 3-month using complementary efficacy criteria~     (ACR 50, ACR 70, DAS 28) in each group of treatment, To assess the clinical and biological~     safety using standard blood monitoring, TEAED and SAE in each group of treatment, To evaluate~     treatment modifications; particularity leflunomide and concomitant use of AINS and~     corticoids.~   "
226263|NCT00596193|"~     Neuropeptide Y (NPY) potently inhibits pain neurons in rats, but does this occur in human~     pain neurons? This hypothesis will be tested using microdialysis probes in patients who elect~     to have root canal treatment or extraction of thier tooth.~   "
226264|NCT00596180|"~     That SPECT brain imaging tracks and is consistent with clinical history and physical exam as~     well as cognitive testing.~   "
226265|NCT00596167|"~     Short-daily hemodialysis is increasingly becoming a preferred alternative to the conventional~     intermittent (three times per week) hemodialysis schedule. Studies have shown that~     short-daily dialysis improves a patient's quality of life, high blood pressure, anemia and~     calcium-phosphorus balance. Infection, however, will likely remain a persistent problem for~     dialysis patients regardless of the frequency of treatments. There is currently a wealth of~     information to guide doctors on how much and how frequently to give an antibiotic for~     patients who receive intermittent (thrice weekly) hemodialysis. However, there is very little~     information on how to prescribe antibiotics for patient's receiving short-daily hemodialysis.~     This study will develop drug dose guidelines for patients receiving short-daily hemodialysis~     for three frequently used antibiotics, vancomycin, levofloxacin and gentamicin. These~     guidelines will assist doctors so that patients receive the most effective dose and frequency~     of an antibiotic to treat their infection.~      The following is the study hypothesis which will be tested with two-sided, one sample t-tests~     comparing the AUC observed to historical measures8.~      1) Vancomycin, levofloxacin and gentamicin are removed to a greater extent by short-daily~     hemodialysis than intermittent hemodialysis.~      The following are the specific aims:~        1. Determine the interdialytic pharmacokinetics of vancomycin, gentamicin, and levofloxacin~          by short-daily HD.~        2. Determine the extent of vancomycin removal when administered during the last hour of~          short-daily HD.~        3. Develop drug-dosing guidelines for vancomycin, gentamicin and levofloxacin for patients~          receiving short-daily HD.~   "
226266|NCT00596154|"~     The purpose of this study is to determine the safety of this new treatment offered in this~     study. PCNSL can be cured in less than half of patients with standard treatment, a~     combination of chemotherapy and brain radiation. Also, the combination of chemotherapy and~     brain radiation may result in serious lasting side effects. Most patients older than age 60~     develop memory problems, difficulty walking or inability to control their bladder. Some~     patients younger than age 60 also develop these side effects.~   "
226267|NCT00596141|"~     The purpose of this pilot study is to determine if Topical Oral Wound Emulsion (TOWE) assists~     with dental wound healing and relieves pain from oral wounds.~   "
226268|NCT00596128|"~     Primary study endpoint: blood sugar values~      Patients: Patients admitted to an ICU~      5 steps:~        1. Routine treatment,~        2. Implementation of SOP for blood sugar monitoring and intervention,~        3. Education of intensive care nurses,~        4. 6 months free interval without further education or check-up of SOP implementation,~        5. Check of SOP implementation and clinical outcome concerning range of blood sugar~   "
226269|NCT00596115|"~     R(+) pramipexole dihydrochloride monohydrate [R(+)PPX], an experimental neuroprotective drug,~     is provided in this open label extension study to ALS patients who have participated in~     earlier clinical protocols.~   "
226270|NCT00596102|"~     The study investigates the long term safety and immunogenicity of the Japanese Encephalitis~     vaccine IC51 up to month 60.~   "
226271|NCT00596089|"~     Decline in muscle function may increase risk of hip fracture and decrease quality of life.~     Different tests are currently used to measure muscle function but they do not work for all~     individuals. A test called jumping mechanography, which measures jumping power, may be~     useful in more people and obtain better information. This study will help us determine~     whether this test is able to detect differences between muscle function in younger and older~     adults, as well as whether it is a safe method to use in all ages.~   "
226272|NCT00596076|"~     The study is an intervention, Phase II COPCORD study. (COPCORD= Community Oriented Program to~     Control Rheumatic Diseases). The purpose of this study is to find if Back School training has~     any benefit on low back pain of the workers in a pharmaceutical factory in Tehran suburbs.~   "
226273|NCT00596063|"~     The purpose of this study is the comparative evaluation of the pharmacokinetics and~     pharmacodynamics of two recombinant regular human insulin injections administered~     subcutaneously in healthy volunteers under the conditions of euglycemic clamp.~   "
226274|NCT00596050|"~     There are multiple retrospective studies detailing the use of etomidate in pediatric~     procedural sedation but few to no prospective clinical trials. None have compared etomidate~     to ketamine, currently the most commonly used sedative in the emergency department for~     pediatric procedural sedation. The investigators propose a randomized, controlled trial~     comparing etomidate versus ketamine for procedural sedation for fracture reduction for~     children presenting with extremity fracture requiring sedation for reduction. The~     investigators hypothesize that etomidate in combination with fentanyl will have similar~     reduction of distress and procedural recall as ketamine in combination with midazolam.~   "
226275|NCT00596037|"~     The objective of this rollover study is to evaluate the long term (1 year) safety of a new~     weekly administered growth hormone preparation in adults with growth hormone deficiency who~     were treated with the same experimental preparation in study BPLG-005. In addition, further~     change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional~     efficacy and safety data of the experimental preparation will be obtained from the~     switch-over patients.~   "
226324|NCT00595361|"~     The purpose of the study is to find out how well a long-acting beta agonist like salmeterol~     works in people with different forms of the same gene. Our hypothesis is that asthmatics with~     the Arg/Arg genotype will have loss of bronchoprotection against exercise-induced asthma with~     regular salmeterol treatment, as compared to asthmatics with the Gly/Gly genotype.~   "
226276|NCT00596024|"~     Oxidative damage by free radicals may be involved in causing Alzheimer's disease (AD). Free~     radicals may lead to death of nerve cells and decline in brain function. Certain antioxidants~     may suppress this free radical damage associated with AD. Carotenoids are a family of~     naturally occurring antioxidants that have important functions for human health. Carotenoids~     are known to reduce oxidative damage, but their effects have not been studied in AD patients.~      The objective of the study is to examine whether lutein supplementation helps to reduce~     oxidative damage from free radicals in AD patients.~   "
226277|NCT00596011|"~     The purpose of this study was to determine whether the daily consumption of decaffeinated~     green tea catechins (Polyphenon E®) for 1 year reduces the rate of progression to prostate~     cancer (PCa) in men diagnosed with HGPIN or ASAP. The aim was to recruit and treat 240 (120~     men/arm) men diagnosed with the prostate condition HGPIN or ASAP with a capsule form of~     standardized green tea extract called Polyphenon E or placebo for a 12-month period and see~     if it can prevent progression of the prostate condition to prostate cancer. Investigators~     wanted to see if Polyphenon E reduces lower urinary tract symptoms and if this can be taken~     safely over one year. Investigators wanted to study how Polyphenon E is able to slow the~     progression to prostate cancer, or the mechanism of action of Polyphenon E. If the safety and~     the effects of Polyphenon E on slowing down the progression of prostate cancer is shown in~     our study, this will be a safe way of treating men who are at high risk or men like you who~     have a prostate condition that increases your chances of getting prostate cancer, so that we~     can prevent prostate cancer in the future.~   "
226278|NCT00595998|"~     The primary objective of this study is to estimate the sensitivity of the HMP test in~     identifying visual field functional defects in subjects with CNV secondary to AMD, and~     differentiate them from intermediate AMD subjects.~   "
226279|NCT00595985|"~     The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second~     line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).~   "
226280|NCT00595972|"~     The purpose of this study is to evaluate the efficacy and tolerability of the ECF regimen~     (epirubicin, cisplatin and FU) combined with endostar-- a inhibitor of angiogenesis, in~     patients with advanced or metastatic gastric cancer (A/MGC).~   "
226281|NCT00595959|"~     The objective of this study is to evaluate the safety and efficacy of the CLiRpath®~     Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in~     combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger~     lumens for treatment within the superficial femoral and popliteal arteries above the knee.~   "
226282|NCT00595946|"~     The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone~     administration in patients with Opioid-induced Bowel Dysfunction.~   "
226283|NCT00595933|"~     The purpose of this study is to compare the effectiveness of over-the-counter remedies for~     dry mouth.~   "
226284|NCT00595920|"~     The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the~     treatment of relapsing forms of multiple sclerosis.~   "
226285|NCT00595907|"~     New blood tests have become available to detect either latent or active tuberculosis. These~     tests - which according to the CDC can replace the tuberculin skin test - measure the~     production of gamma-interferon (a cytokine) by peripheral lymphocytes (white cells) when~     exposed to antigens which are highly specific of mycobacterium tuberculosis (the bacteria~     responsible for tuberculosis). Our hypothesis was that the production of gamma-interferon~     would be much higher at the beginning of treatment than at the end, and that decline in~     gamma-interferon secretion could be an indicator of clinical response to treatment.~   "
226286|NCT00595894|"~     The objective of the proposed study is to assess bone health and determinants of bone health~     among select subpopulations of rheumatoid arthritis patients.~   "
226287|NCT00595881|"~     The purpose of this study is to determine if soft tissue infections in pediatric patients can~     be more accurately diagnosed (i.e. the presence of a drainable abscess) with the addition of~     bedside ultrasound to the clinical examination compared to the clinical examination alone.~   "
226288|NCT00595868|"~     The purpose of this study is to test whether Varenicline can help ambivalent smokers (those~     who are interested in quitting at some point in the future but have no current plans to quit)~     to reduce their smoking and eventually quit.~   "
226289|NCT00595855|"~     Patients affected by medically uncontrolled open angle glaucoma will be randomised to either~     a non penetrating procedure (deep sclerectomy) or conventional trabeculectomy. The longterm~     efficacy (i.e. IOP w/out therapy) and safety (i.e. visual acuity, visual field stability and~     co-morbidities) will be evaluated.~   "
226290|NCT00595842|"~     This study retrospectively looks to determine the clinical success of ProRoot MTA used as an~     artificial apical barrier in teeth with immature apices.~   "
226291|NCT00595829|"~     The purpose of this study is to evaluate the safety and tolerability of the JAK2 inhibitor~     XL019 administered orally in adults with Polycythemia Vera.~   "
226292|NCT00595816|"~     The purpose of this clinical trial is to study the effect of neuromuscular training program~     and regular safety counselling on the risk of musculoskeletal injuries in adolescent~     conscripts.~      800 voluntary participants are recruited from the four army companies in western Finland~     during the years 2007 and 2008.~   "
226293|NCT00595790|"~     The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51~     (JE-PIV) in healthy subjects aged > or = 18 years~   "
226294|NCT00595777|"~     To determine if the institutionalisation of a regular systematic approach to the assessment~     of pain in inpatient cancer units using the Edinburgh Pain Assessment Tool (EPAT©) leads to~     better control of pain than that achieved by usual care.~   "
226295|NCT00595764|"~     The major goal is to determine whether adding cognitive behavioral therapy to physician~     management will increase the efficacy of buprenorphine/naloxone treatment in an office-based~     primary care setting.~   "
226325|NCT00595348|"~     1. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients with family~          history of breast/ovarian cancer.~        2. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients without family~          history, but high risk of hereditary cancer.~        3. To evaluate the prevalence of BRCA1/2 mutation of family member of BRCA1/2 mutation.~        4. To evaluate the prevalence of ovarian cancer of population of above 3 groups.~   "
226296|NCT00595751|"~     The study will evaluate the effectiveness of a standardized EEG method with the intended~     clinical users in the intended clinical settings with the intended population (patients who~     would typically receive a clinician's evaluation for ADHD). Multiple sites will be examined~     to provide a sample of patients across numerous communities with different demographics. The~     goal is to evaluate if the predictive accuracy of EEG will not be inferior to that of a~     widely-used and extensively validated ADHD scale in the prediction of ADHD in the intended~     use population as evaluated by Best Estimate Diagnosis.~   "
226297|NCT00595738|"~     The relationship between peripheral venous saturation and central hemodynamics (including~     right and left heart filling pressures and cardiac output), mixed venous oxygen saturation,~     and contemporary biomarkers of heart failure is not clear. We aim to determine the~     relationship between mixed venous, central venous, and peripheral venous oxygen saturation in~     patients with advanced (class III or IV) heart failure. We will determine the relationship~     between cardiac output measured via thermodilution and the Fick equation calculated using~     concurrent oxygen saturations from the distal PA, central vein, and peripheral vein. We also~     aim to examine the relationship of selected cardiac biomarkers with cardiac filling pressures~     and cardiac output over time in patients with decompensated heart failure.~   "
226298|NCT00595725|"~     The purpose of this study is to learn if a surgical technique called intraoperative lymphatic~     mapping can accurately identify the lymph node that is at greatest risk if endometrial or~     cervical cancer spreads to the lymph nodes.~      Early cervical cancer is usually treated by removing the cervix, tissue around the cervix,~     and the upper vagina. If needed, the uterus is also removed. The treatment also includes~     removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the~     cervix, uterus, fallopian tubes and ovaries.~      The treatment also includes removing lymph nodes from the pelvis.~   "
226299|NCT00595712|"~     The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in~     patients with genovarum deformity using iliac crest allograft compared to the results when~     using iliac crest autograft.~   "
226300|NCT00595699|"~     This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of~     major depression in subjects with temporal lobe epilepsy. The purpose of the study is to~     measure the severity and change in depressive and anxiety symptoms after 10 weeks of study~     treatment with escitalopram or placebo as measured by certain rating scales and~     questionnaires. In addition, the study will measure the frequency of seizures using a patient~     diary during the study. Finally, the study will assess the change in the quality of life~     using rating scales.~   "
226301|NCT00595686|"~     Hsp90 is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an~     experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in~     patients with cancer.~   "
226302|NCT00595673|"~     This trial is to compare PB127 echocardiography to other heart imaging studies.~   "
226303|NCT00595660|"~     Needle size from22 to 25 were used for fine needle aspiration of palpable breast lumps. In~     this study we choose one, randomly, and fallow the result of cytologic evaluation regarding~     specimen adequacy.~   "
226304|NCT00595647|"~     Prospective multicenter controlled randomized trial to compare the safety and efficacy of~     drug eluting vs. bare metal stents in percutaneous coronary interventions of saphenous vein~     grafts. Hypothesis: Survival and outcome will be significantly better in patients receiving~     DES than in patients receiving BMS regarding both short-term and long-term outcome.~   "
226305|NCT00595634|"~     The primary objective of this study is to characterize patients' course of recovery in the~     year following the initial surgery for unstable intertrochanteric hip fractures treated with~     the InterTAN intramedullary hip screw device. This will be done by collecting patient outcome~     measures of health related quality of life and functional status including return to normal~     gait. Secondary objectives are to document any adverse events associated with the procedure,~     and to analyze differences in recovery due to differences in age, gender, co-morbidities,~     nutrition, residence and ambulation status, and use of mobility aids.~   "
226306|NCT00595621|"~     Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the~     treatment of patients with severe diabetic gastroparesis refractory to standard therapy.~   "
226307|NCT00595608|"~     Patients undergoing nasal surgery commonly experience a variety of symptoms in the~     post-operative period including blockage, running, pain, bleeding and reduction in sense of~     smell. A variety of preparations are currently recommended for symptomatic relief in the post~     operative period. These include saline irrigations and sniffs, steam inhalations,~     decongestants and steroid drops.~      There is currently no level 1 evidence in literature to support the use of any particular~     preparation over others in nasal surgical aftercare.~      We propose to conduct a single blinded, randomised trial comparing saline sprays vs Sterimar,~     a commercially available aerosolised isotone saline solution, comparing patients' symptom~     scores following septal surgery.~      The trial will help to establish efficacy and symptom control and advantages of one solution~     and delivery device over the other.~   "
226308|NCT00595595|"~     Millions of teeth are saved each year by root canal therapy. Although current treatment~     modalities offer high levels of success for many conditions, an ideal form of therapy might~     consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and~     replaced with healthy pulp tissue in order to revitalize teeth.~   "
226309|NCT00595582|"~     This is an additional study to the primary Mild Cognitive Impairment (MCI) study~     (LSU#H04-049; NCT00243451)that is underway of PET detection of Mild Cognitive Impairment.~     This study has preliminary data that indicates objective analysis of PET brain image~     metabolic data is a sensitive marker for AD. The goal of this proposal is to determine the~     efficacy of curcumin in the treatment of MCI or mild Alzheimer's Disease (AD).~   "
226310|NCT00595569|"~     To prospectively evaluate the long term metabolic and psychological effects of flexible~     intensive insulin therapy (FIT) courses in an unselected population of type 1 diabetic~     patients at the University of Basel Hospital. We hypothesize that both metabolic control and~     psychological parameters will improve.~   "
226311|NCT00595556|"~     This is a pilot study designed to examine the potential efficacy and tolerability of~     zonisamide compared to placebo for the treatment of alcohol dependence.~   "
226313|NCT00595530|"~     Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage~     effectively. Opioid tolerance and side effects have been major roadblocks in our ability to~     provide these patients with adequate pain relief. This pilot study is designed to examine the~     safety and feasibility of using ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist,~     in the inpatient seeing with children and adolescents who have sickle cell vasoocclusive~     pain. Previous research suggests that in subanesthetic doses, ketamine may be able to prevent~     the development of opiate tolerance and facilitate better pain relief with lower opiate~     doses, allowing for less respiratory depression, less sedation, easier ambulation, less~     deconditioning, shorter hospital stays, and better quality of life. The goal of this pilot~     study is to evaluate the safety and feasibility of using a continuous infusion of ketamine,~     in conjunction with opiates, in the inpatient setting for sickle cell vasoocclusive pain. It~     is hypothesized that using a low dose ketamine infusion in conjunction with opiates will be a~     safe and feasible practice for the treatment of sickle cell pain.~   "
226314|NCT00595517|"~     The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20~     mg once daily for up to 52 weeks of treatment involving patients with a history of gastric~     and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by~     evaluating AE, clinical laboratory value and vital signs.~   "
226315|NCT00595504|"~     This study involves people who have schizophrenia or schizoaffective disorder who are~     currently taking antipsychotic medications. Some antipsychotic medications may cause weight~     gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this~     study is to find out what happens if another medication (ramelteon) is used along with your~     antipsychotic medication. We want to find out whether doing this will:~        -  Change the way your body breaks down fat and sugar.~        -  Affect your waist size, stomach fat and triglycerides (a type of fat in your blood).~        -  Improve how your body responds to insulin.~        -  Affect your quality of sleep.~        -  Reduce movement disturbances Ramelteon is approved by the U.S. Food and Drug~          Administration (FDA) to treat people that have difficulty falling asleep. It is not~          approved for such things as affecting waist size or improving how the body breaks down~          fat and sugar. Its use in this study is investigational.~   "
226316|NCT00595491|"~     Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways~     contribute to airway obstruction. The biological basis for airway inflammation is the subject~     of intensive investigation. This work is designed to identify airway factors that are~     responsible for recruiting cells and associate their airway presence with atopy and asthma.~   "
226317|NCT00595478|"~     The goal is to adapt the family-based CM treatment to target primary adolescent alcohol abuse~     and dependence.~      Specific Aim 1 is to provide a preliminary demonstration of the efficacy of a family-based CM~     intervention to treat adolescent alcohol abuse and dependence. CM components include:~        1. an incentive program to enhance the adolescent's engagement in the treatment process and~          engender alcohol abstinence by providing positive reinforcement for documented~          abstinence via breathalyzers administered by parents regularly at home, self and parent~          report, and clinic-based urine drug testing; and~        2. a parent management training program to enhance and maintain the positive effects of the~          incentive program by teaching parents how to effectively use contingency management in~          the home environment to motivate their adolescent to achieve abstinence and improve~          their behavior in other domains.~      A randomized trial will determine whether the CM intervention enhances outcomes when added to~     a standard individual cognitive behavioral therapy (CBT).~      Specific Aim 2 is to determine whether and how treatment interventions modify parental and~     adolescent risk and protective factors using observational and laboratory measures (parenting~     practices, family functioning, risk taking, delay discounting, and child and parent~     psychopathology) and to determine whether these factors are associated with outcomes over~     time.~      Specific Aim 3 is to test gene x environment (treatment) interactions in adolescent substance~     abuse. Findings will extend the scientific evidence for CM and support the ability of parents~     to implement CM at home. Findings that support the CM model's efficacy will make a~     significant contribution to research on the treatment of adolescent alcohol abuse, which has~     lagged behind research on adult substance abuse and on adolescent illicit drug use.~   "
226318|NCT00595465|"~     The objective is to demonstrate equivalence of three commercial IC51 batches in terms of~     geometric mean titers for anti-JEV neutralizing antibody~   "
226319|NCT00595439|"~     This study will investigate differences among people with focal dystonia (FD), complex~     regional pain syndrome (CRPS) and people who have both conditions to learn more about the~     cause of both disorders.~      Participants undergo the following procedures in five visits:~        -  Electroencephalography (EEG). Electrodes (metal discs) are placed on the scalp with an~          electrode cap, a paste or a glue-like substance. The spaces between the electrodes and~          the scalp are filled with a gel that conducts electrical activity. Brain waves are~          recorded while the subject lies quietly and sensory stimulation is applied to the thumb~          or finger.~        -  Magnetic resonance imaging (MRI). This test uses a magnetic field and radio waves to~          obtain images of body tissues and organs. The patient lies on a table that can slide in~          and out of the scanner, wearing earplugs to muffle loud knocking and thumping sounds~          that occur during the scanning process. The procedure lasts about 45 minutes, during~          which time the patient will be asked to lie still for up to 15 minutes at a time.~        -  Transcranial magnetic stimulation (TMS). An insulated wire coil is placed on the scalp~          and a brief electrical current is passed through the coil. The current induces a~          magnetic field that stimulates the brain. There may be a pulling sensation on the skin~          under the coil and a twitch in muscles of the face, arm or leg. During the stimulation,~          subjects may be asked to keep their hands relaxed or to contract certain muscles.~        -  Peripheral electrical stimulation. In two experiments, TMS is combined with peripheral~          electrical stimulation, similar to what is used in nerve conduction studies, to the~          median nerve at the wrist. There may be muscle twitching.~        -  Surface electromyography. For TMS tests and peripheral electrical stimulation,~          electrodes are filled with a conductive gel and taped to the skin to record the~          electrical activity of three muscles on the right hand.~        -  Needle EMG. A needle is inserted into a muscle to record the electrical activity.~        -  Nerve conduction studies. A probe is placed on the skin to deliver a small electrical~          stimulus, and wires are taped to the skin record the nerve impulses. These studies~          measure the speed with which nerves conduct electrical impulses and the strength of the~          connection between the nerve and the muscles.~        -  Skin biopsy. Two sites are biopsied. A local anesthetic is given to numb the area and a~          1/4-inch piece of skin is removed with a special tool.~        -  JVP domes. Subjects are tested for their ability to discriminate sensory stimuli in the~          affected region and on the other side of it. They are asked to discriminate between~          stamps with grooves of different widths that are applied to the hands or feet.~   "
226320|NCT00595426|"~     To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in~     subjects undergoing primary elective knee replacement surgery~   "
226321|NCT00595413|"~     The primary objective of this study is to evaluate the efficacy of atacicept compared to~     placebo in the treatment of signs and symptoms in a subject population with active rheumatoid~     arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to~     anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.~   "
226322|NCT00595387|"~     This study will compare the effectiveness of cognitive behavioral therapy versus supportive~     psychotherapy in decreasing depression in people with bipolar disorder.~   "
226323|NCT00595374|"~     This trial is conducted in Europe.~      The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin~     NPH in adults with type 1 diabetes on blood glucose control.~   "
226710|NCT00590252|"~     To test and validate newly developed magnetic resonance (MR) pulse sequences for their~     ability to enhance the collection of morphological, biomedical, and functional information~     from the human body. To test clinical protocols on the various MR systems available at~     Brigham and Women's Hospital (BWH).~   "
226326|NCT00595335|"~     This study is being done to investigate the effects (good and bad) of Rituximab for the~     treatment of an autoimmune eye disease called Graves' ophthalmopathy. This disease has proven~     to be difficult to treat. Rituximab is a monoclonal antibody that depletes a line of cells~     involved in the autoimmune response. The study hypotheses is that rituximab is effective in~     the treatment of patients with moderate to severe active Graves' ophthalmopathy.~   "
226327|NCT00595322|"~     This is a pilot study. The goal of this study is to test whether Bevacizumab is safe enough~     in patients with brain tumors so that a larger study can be conducted. This study will also~     give us some information about whether the combination of Bevacizumab and radiation has~     potential to become an effective treatment for regrowing brain tumors.~      Bevacizumab is an experimental drug that blocks a molecule called VEGF that is found in high~     amounts in malignant gliomas. VEGF promotes the growth of blood vessels that bring nutrients~     to tumor cells. In studies with laboratory animals, Bevacizumab slowed the growth of several~     different types of human cancer cells by blocking the effects of VEGF. There is also evidence~     that Bevacizumab enhances the effects of radiation on tumor cell~   "
226328|NCT00595309|"~     The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in~     terms of seroconversion rate.~   "
226329|NCT00595296|"~     This post-approval study is designed to determine the performance of the FDA-approved~     GeneSearch™ BLN Assay when compared to the site's standard of care permanent section~     histological evaluation, and when compared to more extensive histological evaluation when the~     assay is being used by clinicians to make surgical decisions on complete axillary dissections~     (ALND).~   "
226330|NCT00595283|"~     This study will evaluate the effectiveness of parent-child interaction therapy that includes~     an emotion development component in treating depression in preschool children.~   "
226331|NCT00595270|"~     The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and~     the need of a booster dose~   "
226332|NCT00595257|"~     The purpose of this study is to determine if concentrated nucleated cells from your own bone~     marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to~     avoid amputation.~   "
226333|NCT00595244|"~     This trial is to compare PB127 echocardiography to other heart imaging studies.~   "
226334|NCT00595231|"~     This is an eight week, randomized, double blind, placebo-controlled, exploratory study.~     Patients randomized to rufinamide (SYN111) will receive 250 mg BID (total daily dose 500mg)~     for one week then have their dose increased to 500 mg BID (total daily dose 1000mg) for the~     remaining 7 weeks of the study. If the 500 mg BID dose is not tolerated, one dose reduction~     is allowed.~   "
226335|NCT00595218|"~     Limited data exists for the cancer patients' preferences on their patient-doctor interaction~     with their radiation oncologist. These physicians have the opportunity to develop intimate~     relationships with their patients since these patients typically require daily radiation~     treatments anywhere from one to seven weeks. Thus, by having a greater understanding of the~     individual patient preferences, the radiation oncologists will be able to better serve their~     patients leading to improved patient satisfaction with their physician and healthier outlook~     on life. This is the premise and the hypothesis of this study.~   "
226336|NCT00595205|"~     GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting~     infants through the Expanded Program on Immunization (EPI) in Mexico. This protocol describes~     a Phase IV safety study in Mexico designed to further evaluate the safety profile of Rotarix™~     with regard to intussusception (IS). The data generated by this study will be useful for~     public health officers and policy makers in confirming the safety profile of Rotarix™.~   "
226337|NCT00595179|"~     Current assessment of organ tissue viability by surgeons in the operating room is limited to~     crude estimates such as overt physical examination, measurement of laboratory values and~     physical measurements of vascular flow and resistance. The ability to non-invasively measure~     tissue perfusion and oxygenation would provide the surgeon an improved means to assess if an~     injured organ will survive. The recent development of real time infrared (IR) and Near~     Infrared Imaging Spectroscopy (NIRIS) digital cameras has allowed for the determination of~     tissue perfusion and oxygenation in a non-invasive fashion. Although in the early stages of~     development, the application of infrared and NIRS technology holds great promise to permit~     the surgeon to better assess the viability of tissues in ways that have not been possible. We~     propose to evaluate infrared and NIRS technology in the assessment of kidney allografts using~     data previously collected during recipient operations at the NIH.~   "
226338|NCT00595166|"~     This new invention addresses the inadequate and incomplete visualization of the cervix in~     patients with excessive vaginal tissue. In general these patients are obese, or are~     multiparous with a history of multiple vaginal deliveries.~      A vaginal speculum is a vital medical instrument that allows a health care provider to~     visualize the interior aspects of the vagina, as well as the distal portion of the uterus,~     the cervix. It is composed of 2 blades assembled together and held by a handle. The blades~     and the handle form a 90 degree-angle. As the user holds the handle, a lever attached to the~     top blade allows it to open away from the inferior blade.~      When the instrument is inserted into the vagina, the two blades are separated in order to~     keep the anterior and posterior vaginal walls apart. In that position, the cervix and the~     walls of the vagina can be seen if the patient does not have an excess of loose vaginal~     tissue. However, in patients with excessive tissue, the sidewalls of the vagina simply~     collapse toward the midline between the blades because of the fact that no part of the~     speculum is in direct contact with the lateral walls of the vagina. This collapse prevents~     the complete and crucial visualization of the cervix for purposes of cervical cultures, pap~     smears, visual assessment of ruptured membranes, visual assessment of the degree of dilation,~     biopsies, and other procedures requiring access to the cervix or the uterus.~      When clinicians face this dilemma, they may try the largest speculum available, and will open~     it as wide as possible in order to keep the lateral walls apart. Most often, they have to~     improvise by cutting the tip of a condom, or the thumb off a glove, or they use a sterile~     lateral-wall retractor. These other creative solutions can take several minutes of precious~     times and may still result in an inadequate visualization and suboptimal access.~      A vaginal speculum sheath for retaining vaginal tissue in a lateral direction conforms to a~     pair of blades that are movable between an opened position and a closed position. The blades~     in the closed position are adapted for insertion into a vagina, and in the open position,~     they allow dilating the vagina in order to provide access to the cervix.~      This new design includes a flexible, transparent polyurethane sleeve structure that extends~     between the blades when the speculum is opened. The stretched sheath is adapted to retain the~     lateral walls of the vagina in the open position. The elastic sleeve is designed to remain in~     a collapsed configuration when the blades are in a closed position to avoid interfering with~     insertion or withdrawal of the speculum [Reference: U.S. patent 6432048 (2002-8-13)].~     Polyurethane material is FDA approved for vaginal use.~      The purpose of this study is to compare standard of care speculum vs. sheathed speculum in~     the examination of patients with collapsing vaginal sidewalls during a gynecological speculum~     exam.~      The primary hypothesis testing for this study will be to compare the standard of care~     speculum exam to a sheathed speculum exam in a prospective, randomized clinical trial.~   "
226362|NCT00594841|"~     The purpose of this study is to compare non-operative treatment versus operative treatment in~     patients who suffer a complete, acute acromioclavicular (AC) joint dislocation. This study~     will show if one method is superior to the other and will also show advantages and~     disadvantages associated with each treatment method.~   "
226339|NCT00595153|"~     The purpose of this study is to identify the causes of asthma that were not previously~     suspected, to better understand the effects of inhaled steroids on asthma and to identify new~     way to treat asthma. In order to take advantage of the most current scientific expertise, we~     (scientists at UCSF) plan to work together with Genentech Inc. We believe that working with~     Genentech will provide the best chance of developing new treatments for asthma.~   "
226340|NCT00595140|"~     The purpose of the study is to investigate the efficacy of an acute additional application of~     the somatostatin analogue octreotide 100µg s.c. or the dopamine agonist cabergoline 0.5mg~     p.o. to the receptor antagonist pegvisomant during a 6 or 9 hour profile on reducing~     endogenous growth hormone in patients with acromegaly on stable pegvisomant therapy.~   "
226341|NCT00595127|"~     The purpose of this research study is to: (1) determine if the combination of low dose total~     body irradiation, low dose cyclophosphamide and the addition of fludarabine, and a serum to~     suppress the immune system can allow selected stem cells to take and grow; (2) determine if~     selected stem cells from the blood or marrow can take and not cause graft-versus-host disease~     (GvHD), and; (3) evaluate the side effects of the combination of low dose radiation and~     chemotherapy drugs used for these transplants.~   "
226342|NCT00595114|"~     Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases in~     which people experience long-term inflammation of the lungs. Exacerbations, or prolonged~     worsening of symptoms, of asthma and COPD are often life-threatening and can lead to frequent~     need for hospitalization. Even with the proper use of bronchodilators, corticosteroids, and~     other currently available medications, clinical responses among people with COPD and asthma~     are variable. There remains a significant unmet clinical need for new therapeutic approaches~     and insights, including the identification of biomarkers to accurately assess the presence of~     airway infection and intensity of airway inflammation. This study will investigate potential~     natural biological causes and new biomarkers for increased susceptibility to persistent~     airway infection in asthma and COPD.~   "
226343|NCT00595101|"~     To investigate dose response, safety and efficacy of PF-03187207 in patients with primary~     open-angle glaucoma or ocular hypertension~   "
226344|NCT00595088|"~     This study is designed to assess the efficacy and safety of DTA-H19/PEI given as six~     intravesical instillations of 20 mg of plasmid DNA complexed with PEI into the bladder of~     patients with intermediate risk superficial bladder cancer [recurrent stages Ta (low or high~     grade)and T1, (low grade) transitional cell carcinoma (TCC)] who have failed prior~     intravesical therapies including either Bacillus Calmette-Guérin (BCG) or chemotherapy. The~     primary efficacy objective is to determine the effect of DTA-H19/PEI on the prevention of new~     tumors after the induction course of 6 weekly intravesical administrations of investigational~     product assessed 8 to 10 weeks after the start of treatment. Secondary objectives include~     assessing the ablative effect of DTA-H19/PEI on a marker tumor, safety assessed by the~     incidence and severity of adverse events, determining the long-term (46 weeks) continued~     rates of absence of bladder cancer, and time to tumor recurrence in those patients who had a~     complete response (CR) after the induction course.~   "
226345|NCT00595075|"~     Night shift-workers are often advised to take a prophylactic nap prior to starting the shift~     in order to improve alertness and performance. However, individuals often report difficulty~     initiating and maintaining sleep at that time of the day secondary to the alerting influence~     of the near-24 hour circadian rhythm (biological clock). A sleep-promoting medication may~     improve the quality of an evening nap and subsequent alertness and performance during a night~     shift. We will use Ramelteon, a melatonin agonist that is FDA approved for insomnia, in order~     to test the following hypotheses:~        1. ramelteon, compared with placebo, will significantly increase sleep efficiency during a~          2-hour nap;~        2. sleep inertia, as assessed by neurobehavioral tests and subjective and objective~          sleepiness assessments will not be significantly increased after ramelteon treatment~          compared with placebo treatment; and~        3. neurobehavioral performance, subjective and objective sleepiness, and subjective mood~          during a simulated 8-hour night shift will be significantly improved when ramelteon is~          given prior to a prophylactic nap compared to a prophylactic nap with placebo.~   "
226346|NCT00595062|"~     This study was started to validate the possibility of administering radiation therapy during~     surgery to the tissue surrounding the tumor once the tumor has been removed. This surrounding~     breast tissue is at greater risk for developing breast recurrences. This treatment may be as~     effective as the conventional 5-6week radiation treatment in reducing the risk of further~     local recurrences after breast-conserving surgery.~      Through this study, we would like to confirm that this procedure is a safe alternative to~     conventional breast radiation, with no additional side effects when compared with the~     conventional surgery and radiation therapy.~   "
226347|NCT00595049|"~     The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the~     wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial~     hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc).~      The second purpose is to investigate if bosentan affects the enlargement of small vessels in~     the lungs in response to natural chemicals in patients with iPAH and PAH-SSc.~   "
226348|NCT00595023|"~     This study is designed to collect data about the amount of time required to use the assay in~     clinical-use conditions.~   "
226349|NCT00595010|"~     This study will determine the effectiveness of a complex parent training program, based on~     the SafeCare model, in reducing the occurrence of child maltreatment.~   "
226360|NCT00594867|"~     Aspirin is a medication commonly used to relieve minor pains. Aspirin has also been used to~     prevent heart attacks and strokes. Aspirin, however, can also cause damage to the stomach~     and/or intestinal lining leading to the development of erosions (small sores) and/or ulcers~     (large sores). Erosions may cause bleeding (bleeding ulcers) and/or perforations (holes~     in the stomach). Acetaminophen, often referred by the brand name, Tylenol, is also used to~     treat minor pains but is not commonly recognized to cause damage to the stomach lining.~      Many patients often take both of these medications together. While the effects on the stomach~     lining of each medication, when used alone, are known, the effects of both medications, when~     used together, are not.~      The purpose of this study is to show whether or not the collective effects of both aspirin~     and acetaminophen, when used together, increase the damage on the stomach lining when~     compared to either medication alone.~   "
226350|NCT00594997|"~     Our overall goal is to develop, implement, evaluate and disseminate an effective and~     generalizable program to reduce Lyme disease in endemic areas through introducing a~     school-based intervention to children and families. We will:~      1. Deliver an educational program in schools to promote personal protective practices,~     encourage early disease detection and modify residential habitats to reduce tick density.~      3. Evaluate the program's efficacy by comparing the acceptability and practice of~     precautionary behavior, tick density in residential areas and rates of Lyme disease between~     groups using primary and surveillance data sources Evaluate the contribution of knowledge,~     attitudes, and parental involvement to children's adoption of prevention strategies.~      4. Obtain data on the use of single dose tick bite prophylaxis in children and families.~      5. Evaluate the cost of the intervention in relation to its impact on incidence of Lyme~     disease.~      Hypothesis~      The community intervention will reduce the incidence of Lyme disease among children and~     families living in endemic areas by increasing the practice of precautionary behavior and~     reducing tick density in residential areas. Specifically, we hypothesize that:~        1. The educational intervention will reduce the incidence of Lyme disease among children~          and families living in an endemic area.~        2. The educational intervention will improve the childrens' self-confidence (behavioral~          self-efficacy), intention to perform, and actual practice of Lyme disease prevention~          behaviors.~   "
226351|NCT00594984|"~     Part 1: To define the recommended dose of brivanib that can be safely administered in~     combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic~     colorectal cancer (MCRC)~      Part 2: To compare median duration of progression free survival (PFS)~   "
226352|NCT00594971|"~     Background:~      Approximately one third of all deaths in Denmark are caused by cancer. Both Danish and~     international research shows that the majority of terminally ill cancer patients wish to die~     at home. In Denmark only about 25% has this wish fulfilled. The General Practitioner (GP) has~     traditionally had the full responsibility for the palliative care of terminally ill cancer~     patients. In recent years changes have been made to the organisation of palliative care: some~     hospitals have set up specialised palliative care teams and in some areas of Denmark hospices~     have been established.~      Recent research defines a problem when it comes to communication between the hospital and~     general practice when the patient is being discharged. This is often done in a way that can~     cause the patient to feel left in limbo, especially if it is not completely clear to the~     patient and his or her relatives who has the responsibility for the palliative care.~      Objective:~        1. To describe consequences for patients, relatives and health care professionals of three~          different ways of organising palliative care~        2. To collect data which describes patients who are candidates to a shared care approach~          between general practice and a specialised palliative care team~        3. To collect data which describes the palliative phase (place of death and palliative~          care, admissions to hospital, involvement of GP and district nurse etc.)~        4. To describe terminally ill cancer patients and their relatives expectations of the~          health care system~      270 terminally ill cancer patients will be invited to take part in the study. Data will be~     collected by interview with patients and questionnaires for patients, relatives and involved~     health care professionals.~   "
226353|NCT00594958|"~     The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean~     Titers for anti-JEV neutralizing antibody.~   "
226354|NCT00594945|"~     Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.~   "
226355|NCT00594932|"~     We hypothesize that mycophenolate mofetil(Cellcept)is safe and effective for lupus arthritis.~     In this study, patients with lupus will be randomly assigned to receive mycophenolate mofetil~     or placebo (inert pills) for three months. At the end of three months all patients will~     receive mycophenolate mofetil for three additional months. The effectiveness on arthritis and~     other symptoms of lupus will be measured by joint counts and by the BILAG instrument (a~     measure of overall lupus disease activity. Additionally special blood tests aimed at~     understanding the biologic effects of mycophenolate mofetil will also be performed at some~     visits. The primary outcome measurement will be the safety and effectiveness of this~     treatment (as compared to placebo) at the three month point. The trial will continue in a~     blinded fashion (neither the investigator or the participants know who is getting~     mycophenolate and who is getting placebo) until 24 patients have completed the first three~     months of the protocol.~   "
226356|NCT00594919|"~     The following objectives were used for comparison: 1)primary objective: Evaluate the urinary~     excretion of NGAL as a marker of early development of acute kidney injury in patients~     undergoing cardiac surgery.~   "
226357|NCT00594906|"~     The purpose of this study is to compare the effect of the drug teriparatide to the effect of~     placebo on pelvic fracture healing.~   "
226358|NCT00594893|"~     The purpose of the research is to determine if there is a difference between two of the~     commonly used less invasive techniques (surgical methods that use a smaller incision or cut~     in the skin) used to perform total hip arthroplasty (replacement of your painful hip with a~     new ball and socket). It is unclear which of these techniques is associated with a faster~     recovery and lower risk of complications.~   "
226359|NCT00594880|"~     The objective of the study is to compare two different doses of Peg-INF-α-2A (90 or 180~     ug/wk) for their ability to maintain viral control when initiated 5 weeks before ART~     (antiretroviral therapy) interruption in HIV positive, ART-suppressed subjects (viral load~     <50 copies/ml) as determined by observing the percentages of viral load measurements <400~     copies/ml between the two arms over a 24-week period, corresponding to the Pegasys~     monotherapy period (exclusive of dual ART/Pegasys 5-week period). Primary analysis will be an~     intent to treat analysis and will address the hypothesis that two different doses of~     Peg-INF-α-2A (90 and 180 ug/week) will be similarly effective at inhibiting viral~     replication.~   "
226361|NCT00594854|"~     This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6~     months duration is designed to assess the efficacy, tolerability and safety of PN400 versus~     diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric~     ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per~     arm).~      At least 20% of the subjects enrolled will be age 65 years and older.~   "
229967|NCT00546533|"~     To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12~     weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or~     inappropriate.~   "
226364|NCT00594815|"~     The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy~     is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare~     tumor. It is usually treated with chemotherapy and radiation. This combination prolongs~     survival, but about half of patients relapse. The investigators hope that the addition of~     rituximab will improve the control of the tumor.~   "
226365|NCT00594802|"~     Allergy skin tests and allergen immunotherapy are common procedures for both the diagnosis~     and treatment of atopic diseases. Allergen immunotherapy has proved to be effective in~     reducing the symptoms of allergic rhinitis and asthma1-2. Despite its clinical benefit, there~     is risk of systemic reactions associated with these procedures.~      The systemic reaction rate to skin testing for aeroallergens is significant lower than the~     rate of reactions to immunotherapy, but it is not negligible. Lin et al reported only 2~     patients who had systemic allergic reactions to skin testing for respiratory allergies in~     10,400 patients tested.3 They determined the overall risk of inducing anaphylactic reactions~     by skin testing to be less than 0.02% and other studies have produced similar results.4-5 The~     rate of systemic reactions to skin testing is likely underscored. Thompson et. al reported a~     systemic reaction rate of 6% of patients receiving skin testing.6 It is important to~     recognize the risk of systemic reactions seeing skin testing is commonly done. It is also~     imperative to recognize the treatments for these reactions to prevent progression.~      Hypothesis The systemic reaction rate to allergen immunotherapy and skin testing to~     aeroallergens is higher than previously reported. Biphasic anaphylactic reactions rarely~     occur with allergen immunotherapy and skin testing.~   "
226366|NCT00594789|"~     The objective of this study is to evaluate a post-fracture intervention for improving~     osteoporosis care in older men and women who have suffered a fracture that may indicate the~     presence of osteoporosis. Although osteoporosis can be identified with a bone mineral density~     (BMD) test, most individuals with osteoporosis are not diagnosed until they fracture.~     Post-fracture care often falls between the cracks when there is a breakdown in~     communication between hospital and community, or between specialists and primary care~     physicians. Often physicians and patients fail to make the connection between an acute~     fracture and osteoporosis, or the value of secondary prevention strategies. If untreated,~     there is an extremely high rate of additional fractures after a first osteoporotic fracture.~     It follows that improving BMD testing and/or treatment in appropriately identified~     individuals is a necessary step in optimizing post-fracture patient care. Over the next three~     years we will be testing and optimizing a notification procedure to physicians and/or~     patients relying upon fracture events reported to the provincial health service (Manitoba~     Health).~   "
226367|NCT00594776|"~     The purpose of this study is to determine the ability of a cone beam CT to measure bone~     healing.~   "
226368|NCT00594763|"~     In the literature, cases of thrombosis in the venous system have been described in girls and~     women with Turner syndrome. By screening a group of women with Turner syndrome, the~     researchers wish to find out if this condition is more frequent in this patient population.~   "
226369|NCT00594750|"~     The purpose of this study is to identify the causes of asthma that were not previously~     suspected, to better understand the effects of inhaled steroids on asthma and to identify new~     way to treat asthma.~   "
226370|NCT00594737|"~     Memantine has been approved for use in Alzheimer's disease. Its mechanism of action raises~     questions of whether it can also be effective for non-Alzheimer's dementias such as~     frontotemporal dementia (FTD), which currently has no disease-modifying treatment.~      This is an open-label study to probe the effects of memantine in 15 outpatients diagnosed~     with FTD, as shown objectively by comparing PET scans performed before and after use of the~     medication. The specific type of PET scan, FDG-PET, allows the investigators to gauge the~     effects of memantine on cortical activity levels. The investigators hypothesize that subjects~     on memantine will show normalization of cortical metabolic activity.~   "
226371|NCT00594724|"~     The purpose of this study is to see how the brain re-learns to control the tongue in speaking~     and swallowing when either portions of the tongue have been removed, or when the tongue has~     been treated with radiation, in order to treat cancer. We hope the results of this study will~     help us to improve healing for patients who are being treated for cancer of the tongue.~      When patients with cancer of the tongue are treated by removing parts of the tongue (surgery)~     or by destroying the cancer with radiation to the tongue, they have significant difficulty~     speaking and swallowing after such treatments. At this time, patients who have been treated~     for cancer of the tongue re-learn speaking and swallowing through exercises taught by a~     speech pathologist.~      What is needed is information on how the brain re-learns to control speaking and swallowing~     so that we can help these patients re-learn faster after their treatments.~   "
226372|NCT00594711|"~     Outcome of psychodynamic psychotherapy measured by [123I] nor-B-CIT SPET imaging~      Background Psychodynamic psychotherapy is a widely practised form of psychotherapy in the~     treatment of depression. There is evidence that serotonin transporter (SERT) densities are~     altered in depression. Preliminary observations have suggested that SERT function may recover~     in connection with dynamic psychotherapy.~      The objective was to determine whether SERT densities change in relation to clinical recovery~     during psychodynamic psychotherapy.~   "
226373|NCT00594698|"~     The purpose of this study is to evaluate preparation and administration of PB127,~     echocardiographic images obtained during PB127 administration, and evaluate the safety of~     PB127.~   "
226374|NCT00594685|"~     Heparin-induced thrombocytopenia (HIT), a condition characterized by low platelet levels and~     possible blood clots, occurs in a small number of people after treatment with the drug~     heparin. Some people with HIT may show symptoms of a blood clot at the time of HIT diagnosis,~     but in another form of HIT, known as isolated HIT, people do not show blood clot symptoms~     even though they might have a blood clot. This study will use ultrasound tests to evaluate~     the presence of blood clots at the time of an HIT diagnosis and in the following month.~   "
226394|NCT00594425|"~     This multicenter study will be divided into 2 phases. The first phase will be an open label,~     dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled,~     parallel-group, dose-response phase. The second phase will only start if the first phase~     succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne~     vulgaris in the face will be included.The results from part 2 has been presented in the~     result section.~   "
226375|NCT00594672|"~     This study is a 5-year extension of the AREDS protocol, in which investigators followed the~     natural course of age-related macular degeneration (AMD) and cataracts. Participants in the~     former AREDS protocol are eligible for this study.~      Participants have a complete eye examination once a year and are contacted at least once a~     year between visits to check on their status. The eye examination includes measurement of~     visual acuity (vision chart test) and examination of the inside of the eye after the pupils~     have been dilated with eye drops. Photographs of the inside of the eye may be taken using a~     special camera that flashes a bright light in the eye. A blood sample may be obtained to test~     for cholesterol level and genes related to inflammation.~   "
226376|NCT00594659|"~     More US residents are dependent on marijuana than on any other illicit drug, and the number~     enrolled in treatment for marijuana continues to increase such that it is now comparable to~     that for cocaine and heroin. This application seeks to advance the overarching goal to~     develop and disseminate cost-effective treatments for marijuana dependence that can address~     this growing problem.~      The researchers' previous research suggests that an intervention comprising motivational~     enhancement, cognitive-behavioral, and contingency-management components (MET/CBT/CM)~     produces greater rates of successful and durable outcomes than has been demonstrated~     previously. However, three issues relevant to its efficacy and eventual dissemination must be~     confronted. First, the outcomes achieved can only be characterized as modest; many~     individuals do not respond to the treatment and relapse rates remain problematic. Second,~     access is limited by the availability of trained providers. Third, the cost of delivering the~     treatment is higher than more traditional outpatient interventions.~      To address these issues, Specific Aim 1 is to develop and test a computer-assisted version of~     MET/CBT/CM. Computerized treatments have the potential to increase overall effectiveness of~     treatment services by increasing availability of and access to potent treatments, and by~     applying innovative technology to enhance outcomes. During Year 1, the intervention will be~     developed and pilot tested. An interactive program that showed promise in a previous trial~     for opioid dependence will be modified and enhanced to deliver individualized MET/CBT/CM~     using effective computer learning technologies. These technologies and access to the~     MET/CBT/CM program made available via the Internet between treatment sessions and after~     treatment ends have the potential to promote better learning and more use of coping skills,~     which in turn can improve outcomes. During Years 2-4 a randomized trial will provide an~     initial efficacy test of cMET/CBT/CM by comparing it with a brief treatment (MET) and with~     therapist-delivered MET/CBT/CM. Specific Aim 2 is to learn more about how behavioral~     treatments like MET/CBT/CM work by focusing on two putative mechanisms of action examined in~     prior trials: self-efficacy/coping skills and impulsivity/delay discounting. The experimental~     design will provide a unique opportunity to explore such mechanisms in a novel context- where~     the therapist is vs. is not a prominent part of the treatment.~      The proposed project will address the objectives of NIDA's Behavioral and Integrative~     Treatment Development Program by providing research on technology-assisted treatment that~     attempts to make treatment delivery less complex, easier to access, and less costly - while~     retaining or improving its effectiveness. Findings will inform future studies designed to~     refine the technology and how it is applied; conduct more definitive effectiveness testing;~     test generality to other populations including adolescents; and to further advance~     translation to community settings.~   "
226377|NCT00594646|"~     This study will evaluate how safe and tolerable a combination of taking three-drugs will be~     for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in~     HIV uninfected adults.~   "
226378|NCT00594633|"~     A significant number of brain tumor patients who received radiation or chemotherapy have~     thinking problems as a result of their treatment. The purpose of this study is to find out if~     treatment with Aricept (donepezil) may improve some aspects of thinking abilities in patients~     with brain tumors who received radiation or chemotherapy. This research will also study~     whether persons having particular genes for a blood-borne substance called apolipoprotein E~     (APOE) are more likely to have thinking problems after radiation or chemotherapy treatment~     for their brain tumors. The findings of this study will help us find out whether Aricept can~     improve thinking abilities after cancer treatment, and whether some of the thinking~     difficulties may be in part related to having certain genes.~   "
226379|NCT00594620|"~     To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are~     being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control~     of advanced prostate cancer~   "
226380|NCT00594607|"~     The purpose of this study is to investigate whether the dialysis filter AN69ST (Nephral 400~     ST Dialysis Membrane) induces less clotting during hemodialysis than a conventional~     polysulphone filter. Our hypothesis is that the two filters induce the same degree of~     clotting.~   "
226381|NCT00594594|"~     We hypothesize that probiotic Lactobacillus can augment antibiotic treatment of symptomatic~     urinary tract infection (UTI) in spinal cord injured patients, and also increase the time to~     the next episode of UTI.~   "
226382|NCT00594581|"~     This study was undertaken to investigate safety and scar-improvement activity of different~     applications of Juvista (avotermin), administered to surgical incisions made to the skin of a~     healthy population of male volunteers aged 18-45 years. The study addressed two issues:~     whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more~     effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once~     only (before wounding) or twice (before and after wounding) is optimal for scar improvement.~   "
226383|NCT00594568|"~     Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no~     cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta-amyloid~     (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD~     patients are required to have these amyloid plaques in the brain in order to have a~     definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the~     production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and~     was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in~     blood, spinal fluid, and brain in animals tested thus far. This study used several different~     tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some~     participants. The build-up of amyloid plaques was measured by a brain scan that takes a~     picture of amyloid plaques in the brain. Other tests measured the overall function of the~     brain and brain size in some participants. In this trial, participants who initially received~     placebo (inactive sugar pill) were, at a certain point in the study, switched over to active~     drug, semagacestat. In other words, all participants could eventually receive active drug.~     Participation could last approximately 2 years. Participants taking approved AD medications~     were permitted to participate in this study and continue taking these medications during the~     study. All participants who completed this study had the option to continue receiving~     semagacestat by participating in an open-label study.~      Preliminary results from this study (H6L-MC-LFAN [LFAN]) and another similar study~     (H6L-MC-LFBC [LFBC; NCT00762411]) showed semagacestat did not slow disease progression and~     was associated with worsening of clinical measures of cognition and the ability to perform~     activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC, and~     open-label H6L-MC-LFBF (LFBF; NCT01035138) were amended to continue collecting safety data,~     including cognitive scores, for at least 7 months. The Clinical Trial Registry (CTR) will~     reflect results of analyses from the original LFAN protocol in addition to those from the~     amended LFAN protocol.~   "
226384|NCT00594555|"~     The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG~     regimen) with Imatinib Mesylate (Gleevec) in patients with AML.~   "
226385|NCT00594542|"~     The purpose of the study will be to demonstrate whether Mohs micrographic surgery can be~     performed with a lower total dose of local anesthesia (and greater patient safety) when using~     0.5% lidocaine with 1:200,000 epinephrine versus 1% lidocaine with 1:100,000 epinephrine.~   "
226386|NCT00594529|"~     The purpose of this study is to evaluate the safety of liver resection for metastatic,~     resectable lesions from colorectal cancers after systemic chemotherapy.~   "
226387|NCT00594516|"~     The objective of this study is to test the idea that the immediate-release (IR) form of~     tapentadol (CG5503) can be directly converted into an approximately equivalent total daily~     dose (TDD) of the extended-release (ER) form, and vice-versa, with equivalent safety and~     efficacy.~   "
226388|NCT00594503|"~     Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in~     patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.~   "
226389|NCT00594490|"~     This trial will evaluate the outcome of placement of silicone breast prosthetics.~   "
226390|NCT00594477|"~     This study delivers radiation therapy to any residual breast tissue and the chest wall plus~     lymph node areas around the breast. These lymph node areas are under the arm, around the~     collar bone, and under the sternum (breastbone).~   "
226391|NCT00594464|"~     Evaluation of efficacy and safety on the use of rotigotine in patients suffering from~     Parkinson's Disease during and after surgery requiring general anaesthesia.~   "
226392|NCT00594451|"~     The objective of the proposed study is to assess the role of smoking and complex gene-smoking~     interactions in two understudied Rheumatoid Arthritis (RA)groups.~   "
226393|NCT00594438|"~     The purpose of this study is to compare the quantity of fat that is released into the venous~     system (blood) by reaming the femoral canal during intramedullary nailing of the femur using~     two different reaming systems.~   "
227132|NCT00584493|"~     The purpose of this study is to provide access to CP-675,206 for patients with advanced~     unresectable melanoma and who have the potential to gain benefit from this treatment and who~     are not eligible for participation in other CP-675,206 studies.~   "
226395|NCT00594412|"~     This study will determine whether a magnetic resonance imaging (MRI) test of the liver can~     accurately measure the amount of fat in the liver compared to the results of a liver biopsy.~      People 18 years of age and older who are scheduled to have or who have already had a liver~     biopsy as part of their medical care within 1 month of enrollment in this study may be~     eligible to participate.~      Participants undergo an MRI. For this procedure, the subject lies still on a table that~     slides into a narrow metal cylinder (the MRI scanner) for 30 to 60 minutes. A special pad or~     tube is placed around the abdomen to improve the image of the liver obtained. Earplugs are~     placed in the ears to muffle loud thumping and knocking sounds that occur with the electrical~     switching of the magnetic field. The findings of the MRI are compared with those of the liver~     biopsy.~   "
226396|NCT00594399|"~     This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40)~     with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled~     clinical trial (n=300) to determine the effect of a one-year physical activity counseling~     intervention on glucose metabolism and secondary outcomes compared to usual care.~   "
226397|NCT00594386|"~     The objective of this open-label extension is to assess the safety and tolerability of~     long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic~     Parkinson's Disease.~   "
226398|NCT00594373|"~     Topical microbicides, substances that kill microbes, are being studied to prevent sexual~     transmission of HIV and other disease-causing agents. In the future, topical microbicides may~     be applied vaginally to prevent both acquisition and transmission of HIV and other sexually~     transmitted infections (STIs). The purpose of this study is to assess whether there is a~     measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in~     women at low risk for HIV infection.~   "
226399|NCT00594360|"~     The purpose of this study is to evaluate the effect of a primary healthcare intervention~     called 'Exercise on Prescription' aimed at increasing level of physical activity and~     psychological parameters in a population of sedentary patients with increased risk of~     developing lifestyle diseases. The effect is evaluated using patient-reported variables.~   "
226400|NCT00594347|"~     The present study intends to investigate the use as a booster of a dose of sanofi pasteur's~     Pneumo 23 vaccine in the second year of life following 3-dose priming with Wyeth's Prevnar~     vaccine. The researchers will use a cohort of subjects who have received 3 doses of Prevnar®~     at 2, 4, 6 months of age in the context of the clinical study A3L12 on Hexavalent combined~     vaccine (DTaP-IPV-HB-PRP~T)~   "
226401|NCT00594334|"~     Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial~     periodontal effects.~   "
226402|NCT00594321|"~     The objective of the clinical trial is to evaluate the SPACE 360 Delivery System using SPACE~     CpsXL Bone Cement compared to standard vertebroplasty in the treatment of pathological~     fractures of the spine caused by metastatic tumors of the spine, myeloma, or lymphoma. Up to~     a total of three levels per patient may be included or five levels for multiple myeloma. The~     control group will be standard vertebroplasty.~   "
226403|NCT00594308|"~     The purpose of this study is to compare the effects (good and bad) of the medication~     basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of~     graft-versus-host disease.~      This research is being done because there is no completely safe and effective prevention for~     graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to~     know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after~     a transplant known as nonmyeloablative (mini transplant).~   "
226404|NCT00594295|"~     Brittle and broken bones can occur after organ transplantation. However, the long-term~     effects of bone marrow transplantation on bone health and the risk of breaking bones are not~     well understood. This study will help to assess how common it is for those who have received~     a bone marrow transplant to have fractures. It will also investigate blood tests related to~     bone health. This will be done by measuring bone mineral density and obtaining blood tests.~   "
226405|NCT00594282|"~     The objective of this study is to assess whether use of a mammography breast plate cushion~     will significantly decrease the level of discomfort experienced by African American women~     during routine screening mammograms. The primary hypothesis is that use of the breast plate~     cushion will result in less mammography-related discomfort. The secondary hypotheses are that~     women who anticipate high levels of discomfort will experience greater reductions in~     discomfort when a breast plate cushion is used and participants who received mammograms using~     a breast plate cushion will have greater intentions to return for a routine mammogram than~     the control group.~   "
226406|NCT00594269|"~     The aim of this study is to discontinue antipsychotics and antidepressants, and to study its~     effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).~   "
226407|NCT00594256|"~     The present protocol proposes study of the recently approved compound sodium oxybate (Xyrem),~     a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist,~     for the study of persistent symptoms of schizophrenia. Sodium oxybate is a central nervous~     system depressant currently approved for treatment of narcolepsy associated with cataplexy~     and excessive daytime sleepiness. In addition to evaluating effects on sodium oxybate on~     persistent symptoms and neurocognitive deficits in schizophrenia, the study will test the~     hypothesis that this medication may be particularly effective in combating Insomnia Related~     to Schizophrenia, and in normalizing symptomatic and polysomnographic manifestations of~     sleep-related brain dysfunction in schizophrenia.~   "
226418|NCT00594113|"~     The primary purpose of this study is to determine the effectiveness of a multi-media~     presentation and survey to increase screening for colorectal cancer. Content of this~     presentation is based on the concept of implementation intentions, an advanced planning~     model taken from the Theory of Planned Behavior. The multi-media presentation is delivered in~     a touch-screen computer format and contains messages about colorectal cancer that are~     tailored to each participant based on individual survey responses. It is hypothesized that~     tailored messages and defining implementation intentions may have a relationship with~     completion of colorectal cancer screening.~   "
226419|NCT00594100|"~     To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with~     approved carotid stents to an Objective Performance Criterion derived from distal embolic~     protection studies.~   "
226408|NCT00594243|"~     This pilot feasibility experimental study is designed as a randomized wait-list controlled~     trial of mindfulness meditation for CLBP. A sample of 37 older adults 65 years of age and~     older will be recruited from a chronic pain clinic, posted flyers, and newspaper~     advertisements over a 6-month period. Eligibility will be determined by self-report from a~     checklist reviewed with potential participants over the phone (see appendix for checklist).~     Pre-intervention study participants will be consented and study measures obtained. After~     consent and baseline measures, participants will be randomized in blocks of six using a~     simple randomization process with no stratification using a table of random numbers. After~     randomization, participants in the intervention group will receive the intervention of eight~     weekly 90-minute mindfulness meditation sessions. Instead of waiting until all 37~     participants have been recruited into the study to do the intervention, the intervention will~     be done on a rolling basis. This means there will be a minimum of 6 participants per~     intervention group, with the possibility of three separate intervention groups. If~     recruitment goes better than expected, then we will offer the intervention to all 18~     participants at one time. Controls will not receive any intervention during this time.~     Immediately post-intervention the measures will be administered again to participants and~     wait-list controls. Once the intervention is complete and participants and wait-list controls~     have completed post-intervention measures the mindfulness meditation program will be offered~     to the wait-list controls. We will try to combine the wait-list controls into one eight-week~     program. 3 months after the intervention is completed, participants will be asked to complete~     the measures a third time and any mindfulness meditation they continue to do at home will be~     quantified.~      The primary hypotheses are:~        1. We expect to be able to recruit 37 eligible individuals with CLBP into the study within~          a six-month period.~        2. We expect participants randomized to the mindfulness meditation intervention to meet an~          adherence standard of attending 75% of the 8 weekly 90-minute sessions.~        3. We expect mindfulness meditation will result in a moderate effect size difference (0.5)~          between the intervention participants and wait-list control participants on outcome~          measures of pain, mood, physical function, attention, and QOL.~   "
226409|NCT00594230|"~     This will be a single arm Phase II study.~   "
226410|NCT00594217|"~     The rapidity with which progesterone (P) suppresses daytime lutenizing hormone (LH) (and by~     inference gonadotropin releasing hormone (GnRH)) pulse frequency is unknown. We propose to~     assess this further using a randomized, cross-over, placebo-controlled study. Ovulatory women~     will begin E2 patches on day 4-8 of the cycle, while women with PCOS will begin E2 patches~     either on day 4-8 of the cycle or at least 8 weeks post-menses. After 3 d of E2~     administration, women will undergo a 24-h sampling study in the GCRC. Beginning at 2000 h,~     blood for LH, FSH, E2, P, and T will be obtained over a 24-h period. After 10 h of sampling,~     either oral micronized P (100 mg p.o.) suspension or placebo suspension will be administered~     (according to randomization). At the completion of sampling, E2 patches will be discontinued.~     During a subsequent menstrual cycle (or after at least 3 weeks in oligomenorrheic PCOS),~     subjects will undergo another GCRC study identical to the first (including pretreatment with~     E2) except that oral P will be exchanged for placebo or vice versa in accordance with the~     crossover design. We will assess the acute effects of progesterone on LH frequency, with~     secondary endpoints being mean LH, LH pulse amplitude, and mean follicle-stimulating hormone~     (FSH). We propose two primary hypotheses: (1) administration of P (at 0600 h) to normally~     cycling adult women during the follicular phase will result in a demonstrable suppression of~     daytime LH (and by inference GnRH) pulse frequency within 12 hours; (2) administration of P~     (at 0600 h) to women with PCOS will result in less suppression of daytime LH pulse frequency~     than in ovulatory women without PCOS. A secondary hypothesis is that augmentation of LH~     amplitude after P administration will be less in PCOS compared to normal controls.~   "
226411|NCT00594204|"~     The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline~     compared to placebo for smoking cessation. Abstinence from cigarette smoking and other~     tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period~     will also be evaluated.~   "
226412|NCT00594191|"~     The purpose of this study is to evaluate the effects of continuous simvastatin administration~     on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its~     safety in patients with cirrhosis and portal hypertension.~   "
226413|NCT00594178|"~     Spinal cord injury (SCI) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that~     decrease quality of life and prevent effective rehabilitation. Previous findings from our~     labs found that a passive cycling exercise program, motorized bicycle exercise training~     (MBET), in adult spinally transected animals reduced muscle atrophy and normalized~     hyperreflexia. We found that MBET could prevent the onset of hyperreflexia after spinal~     transaction, that MBET could also be used to rescue from hyperreflexia once it had set in,~     and that MBET could induce savings in normalization of reflexes after MBET ceased. We also~     demonstrated that MBET was effective in rescuing from hyperreflexia in a chronic ASIA B SCI~     patient, and that short-term MBET could lead to brief savings in normalization of reflexes~     once MBET ceased. The proposed studies will test the ability to MBET to prevent the onset of~     hyperreflexia in a group of acute SCI patients trained before hyperreflexia has had a chance~     to set in. In addition, the proposed research will attempt to confirm the possibility that~     long-term MBET in chronic SCI patients will rescue from hyperreflexia once it has set in, and~     also produce significant savings in normalization of reflexes if carried out for long periods~     of time. We will also test the possibility that MBET in acute and/or chronic SCI patients~     could reduce or prevent muscle atrophy. The experimental design calls for assessing muscle~     mass using MRI scans, bone density using Dual-Energy X-ray Absortiometry (DEXA) scans,~     spasticity measures and electrophysiological measurements to determine low frequency~     habituation of the H-reflex. Assessments will be carried out before MBET, during a 25 week~     MBET block of time, and during a 12 week post MBET monitoring period. Changes in muscle mass,~     bone density, spasticity scales and H-reflex habituation will be compared across these~     interventions and between treated SCI victims and a group of control acute and chronic SCI~     victims undergoing standard of care during the same period.~   "
226414|NCT00594165|"~     The objective of this open-label extension is to assess the safety and tolerability of~     long-term treatment of the rotigotine patch in subjects with early-stage idiopathic~     Parkinson's disease.~   "
226415|NCT00594152|"~     Investigators with the goal of optimizing glycemic and blood pressure control saw type 1~     diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per~     day; an intravenous insulin pulsed infusion group received, in addition, three one hour~     infusions in a pulsatile fashion over one eight hour period each week. Patients were followed~     for 12 months with periodic testing of renal function by repeated blood and urinary analyses;~     diabetes control by blood testing and diabetes impact measurement score; cardiac and~     autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual~     changes with repeated fundus photography. The study hypothesis was that correction of~     respiratory quotient would correct the defect leading to microvascular complications of~     diabetes (Type 1).~   "
226416|NCT00594139|"~     Subjects with non-neurogenic over-active bladder will be enrolled. The hypothesis is that~     augmentation cystoplasty using an autologous neo-bladder construct will increase functional~     capacity and thereby reduce the number of micturition episodes per day in subjects with~     non-neurogenic over active bladder and urge predominant incontinence.~   "
226417|NCT00594126|"~     The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of~     GRN163L when administered to patients with refractory or relapsed multiple myeloma.~   "
226461|NCT00593554|"~     The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an~     improvement in treatment-related mortality (TRM) rate at 6 months.~   "
226462|NCT00593541|"~     This Protocol is intended to facilitate development and testing of new cardiovascular MRI~     software capabilities by UC Davis Research Faculty, as well as to facilitate the evaluation~     of new software capabilities provided by GE and Siemens.~   "
226420|NCT00594087|"~     The purpose of this study is to determine if people with multiple sclerosis (MS) and fatigue~     have disrupted sleep, as was suggested in previous studies, and whether treating the~     disruptions of sleep improves the fatigue.~      Eszoplicone, a new drug FDA approved for the treatment of insomnia, will be used to control~     sleep disturbances in MS patients with fatigue.~      The study will last 7 weeks, 5 of which will involve being on medication. You will take~     eszopiclone or placebo (sugar pill), keep a sleep diary and wear an actigraph, a device about~     the size of a digital watch that monitors and records sleep activity. You will randomly be~     chosen to get either placebo or medication. Half the subjects will get placebo and half~     eszopiclone. The decision will be made by a pharmacist (who does not know you) according to a~     randomization table. Neither you nor the investigating physician will know whether you are on~     sugar pill or medication. At both the beginning and the conclusion of the study you will be~     asked to fill out 2 questionnaires to evaluate fatigue and depression and undergo some memory~     and speech tests. The testing will take about 2 hours. Actigraphy is a wrist-worn, watch like~     device that records activity during waking and sleeping without application of any sensors.~     It consists of a movement detector, so it can record movement and non-movement data for a~     week or two. You should wear it continuously during wakefulness and sleep as you go about~     routine daily activities. You should only take it off if you are going to shower, bathe or~     swim. A sleep log is a graph on which, for 2 to 3 weeks, you will record bedtime, approximate~     sleep time, times and duration of awakenings during the sleep period, final awakening time,~     and naps taken during the day to the best of your knowledge. You will also be asked to avoid~     getting pregnant. If you are a woman who may have the potential to get pregnant then a~     pregnancy test may be performed at the beginning of the study, before you receive the~     medication, at the first follow up visit and when you end the study.~   "
226421|NCT00594074|"~     This pilot study looks at the relationship of moderate alcohol consumption on weight loss.~   "
226422|NCT00594061|"~     The purpose of this study is to evaluate whether the Iowa/Nucleus 10/10 mm in one ear, in~     conjunction with a Nucleus Freedom implant in the other ear can provide useful binaural~     hearing in pediatric subjects who have bilateral severe to profound hearing loss and meet the~     criteria for cochlear implantation. The Iowa/Nucleus 10/10 mm cochlear implant has a short,~     10 mm electrode array that it is inserted only into the more basal region of the cochlea.~     Unlike a conventional cochlear implant, the Iowa/Nucleus 10/10 mm is expected to preserve the~     regions of the cochlear partition that are apical to the electrode, thus leaving them~     available for possible future advances in the field of otolaryngology and hearing devices,~     such as mammalian hair cell regeneration techniques or improved implantable hearing devices.~     The Iowa/Nucleus 10/10 mm will be implanted in the contralateral ear from the Nucleus Freedom~     electrode array as a means of providing bilateral stimulation of auditory pathways while~     preserving the middle and apical regions of the scala media.~   "
226423|NCT00594048|"~     The purpose of this study is to determine whether breathing-exercises with the Resperate or~     listening to a discman with freely chosen music are effective in the treatment of~     hypertension~   "
226424|NCT00594035|"~     To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural~     repair compared with standard of care methods (control) to obtain watertight dural closure in~     patients undergoing spinal surgery.~   "
226425|NCT00594022|"~     The purpose of this study is to determine whether a small electrical current to the~     vestibular nerve (balance organ) will decrease the time it take for participants to fall~     asleep.~   "
226426|NCT00594009|"~     The purpose of this study to determine the safety and effectiveness of a mechanical device to~     remove carbon dioxide from the blood of patients with chronic obstructive pulmonary disease~     (COPD)when they are hospitalized in the intensive care unit for exacerbation of their~     condition.~   "
226427|NCT00593996|"~     People who do not have adequate amounts of vitamin D develop weakness of leg and arm muscles.~     This study will determine if vitamin D supplementation benefits muscle functions important~     for swallowing, bladder and bowel function.~   "
226428|NCT00593983|"~     African Americans and Latinos are increasingly affected by HIV/AIDS in the United States.~     Despite the increase in the number of infections in minority populations, these individuals~     are not adequately represented in AIDS clinical trials (ACTs). The purpose of this study is~     to identify effective intervention strategies to increase the number of HIV infected~     racial/ethnic minorities and women who are screened for and enrolled into ACTs.~   "
226429|NCT00593970|"~     Pregnant women have limited knowledge regarding influenza, its implications during pregnancy,~     and recommendations for vaccination during pregnancy. The researchers plan to distribute an~     information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits,~     and then give a questionnaire on the postpartum floor assessing knowledge.~      The researchers hypothesize that with education intervention, knowledge scores on the~     questionnaire will be higher than those from last year, when no education was provided.~   "
226430|NCT00593957|"~     Increased brain glutamate and its N-methyl-D-aspartate (NMDA) receptors found in the brain of~     younger Rett syndrome (RTT) patients cause toxic damage to neurons (the brain's nerve cells),~     and contributing to EEG spikes. Dextromethorphan (DM) acts by blocking NMDA/glutamate~     receptors. This study is being done to determine if DM will prevent the harmful~     over-stimulation of the neurons thereby reducing EEG spike activity. Treatment with DM~     consists of one of 3 different doses (0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day),~     and aims to find out which dose if any will help improve EEG abnormalities, behavior,~     cognition, and reduce seizures, as well as improve breathing abnormalities, motor~     capabilities, bone density, and GI dysfunction.~      The study will include 90 females and males with RTT, 2 years-14.99 years of age, with a~     mutation in the methyl CpG binding protein 2 (MECP2) gene, and spikes on EEG, with or without~     clinical seizures.~   "
226431|NCT00593944|"~     The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and~     tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses~     that patients may have to the drug will also be collected.~   "
226432|NCT00593931|"~     This Protocol is intended to facilitate development and testing of new techniques for~     functional MRI by UC Davis Research Faculty, as well as to facilitate the evaluation of new~     techniques provided by the system manufacturers (GE and Siemens).~   "
226433|NCT00593918|"~     In this project we will study the capacity for single nucleotide polymorphisms (SNP) in TLR4~     gene to induce varying levels of inflammatory chemokine and cytokine production.~   "
226495|NCT00593112|"~     This will be an open label study using daily does of up to 126mg/day of Concerta in the~     treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD.~     Specific hypotheses are as follows:~      Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC~     Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine +~     phosphocreatine (Glu/Cr) than matched HCS.~      Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC~     Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.~   "
226434|NCT00593905|"~     Our goal is to determine clinically in Pulmonary Arterial Hypertension patients if~     associations exist between the efficacy and toxicity of sitaxsentan, bosentan, and~     ambrisentan and several gene polymorphisms in several key disease-specific and therapy~     specific genes. Also characterized is the relationship between these polymorphisms and the~     severity of Pulmonary Arterial Hypertension using either baseline hemodynamic or clinical~     surrogates for disease severity.~      Hypothesis: Polymorphisms influence the efficacy and toxicity of specific Pulmonary Arterial~     Hypertension therapy as well as development/severity of PAH via their effect on PA~     remodeling, drug response, or metabolism.~      This study requires a one time 8.5 ml blood sample and clinical data to be obtained at~     initiation of therapy, 4 months after initiation of therapy and 12 months after initiation of~     therapy.~   "
226435|NCT00593892|"~     The purpose of this study is to determine if the type of surgery (orthopaedic, general~     surgery, thoracic, etc.) affects the level of cytokines and thus potentially the risk of~     multisystem organ failure.~   "
226436|NCT00593879|"~     Depressed patients will receive 6 weeks of citaloprma (20-40mg) therapy. Subjects who have an~     inadequate response (partial or non-responder) will be randomized to receive either~     mecamylamine (5-10mg) or placebo added to their citalopram for a further 8 weeks.~   "
226437|NCT00593866|"~     This is a research study for pancreatic cancer. One way of improving the results of current~     standard treatments is to try new approaches. This study will examine the use of a more~     advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT),~     with chemotherapy. All subjects on this study will be treated with gemcitabine. This~     chemotherapy agent has been used for patients with pancreatic cancer. The researchers have~     already done studies using radiation therapy and gemcitabine. They want to build on the~     information they have from this previous research. The researchers want to find the best dose~     of IMRT that can be given at the same time that patients are receiving gemcitabine. To do~     this, they will vary the total dose of radiation received by patients on this study based on~     the information they have available from previously treated patients. The goal of the~     research is to identify the highest dose of IMRT that can be given at the same time as the~     chemotherapy without causing severe side effects.~   "
226438|NCT00593853|"~     The purpose of this study is to determine if methylphenidate improves fatigue in men~     undergoing hormonal therapy for prostate cancer with an LHRH-agonist.~   "
226439|NCT00593840|"~     The purpose of this study is to determine if reducing or eliminating radiation treatment to~     one or both sides of the neck where there is no evidence of cancer can help spare the side~     effects of radiation treatment for head and neck cancer. In this study, the investigators~     plan to reduce the amount of radiation treatment received to healthy tissue~   "
226440|NCT00593827|"~     The purpose of this study was to determine the effects of the weekly regimen of ixabepilone~     dosing compared to the once every 3 week dosing regimen in participants with metastatic~     breast cancer.~   "
226441|NCT00593814|"~     The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated~     Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic~     aneurysms.~   "
226442|NCT00593801|"~     Objective: To investigate whether recombinant EPO reduces the need for transfusion in~     extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.~      The concentrations of trace elements and of antioxidant enzymes were investigated in all~     patients, too.~      Study population: 219 patient randomized into 3 groups~   "
226443|NCT00593788|"~     The aim of this study was to establish parameters for the Gaps-in-Noise test in~     normal-hearing young adults. One hundred subjects (50 males and 50 females) received an~     audiological evaluation to rule out hearing loss and auditory processing disorder. The~     Gaps-in-Noise test was then conducted on all subjects. The mean gap detection threshold was~     4.19 msec. A psychometric function by gap duration was constructed, revealing that the~     percentage of correct responses was less than or equal to 5% for a gap duration of 2 msec,~     10-30% for a gap duration of 3 msec, 60-70% for a gap duration of 4 msec, and over 96% for~     gap durations of 5 msec or longer. The results suggest that the data obtained can be applied~     as reference values for future testing. In the subjects evaluated, the Gaps-in-Noise test~     proved to be consistent with low variability.~   "
226444|NCT00593775|"~     The successful hatching process is a prerequisite for implantation. Freezing/thawing cycles~     can impair the hatching process by introducing changes in the composition of the zona~     pellucida. The purpose of this study is to test the hypothesis that the implantation rate per~     embryo and the clinical pregnancy rate per embryo transfer is higher after embryo transfer of~     frozen-thawed embryos with opened or thinned ZP after assisted hatching when compared to~     embryo transfer of frozen-thawed embryos without assisted hatching.~      All patients starting a thawing cycle (with frozen embryos on d1-d2-d3-d5) can be included in~     this RTC study. Assisted hatching will be performed with a non-contact 1.48 diode laser~     system (MTG, Germany).~   "
226445|NCT00593762|"~     The purpose of the study is to determine the response to aspirin (ASA) and Clopidogrel in~     patients with peripheral arterial occlusive disease (PAOD) requiring interventional~     procedures and to investigate if patients with resistance to ASA or Clopidogrel have an~     unfavourable outcome during long-term follow-up~   "
226446|NCT00593749|"~     The proposed research will evaluate the efficacy of an intervention in urban corner stores.~     Community-based, environmental manipulation of corner stores is an understudied area and~     represents the next step in understanding and improving the nutritional intake of school~     students to prevent obesity.~   "
226447|NCT00593736|"~     The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to~     advance the timing of sleep in individuals with delayed sleep phase syndrome.~   "
226448|NCT00593723|"~     Concurrent chemotherapy and radiation therapy are the standard of care for inoperable~     patients with esophagus cancer. Unfortunately, the 5-year survival of 20% for this population~     is quite low. Methods to intensify radiation therapy delivery without increasing local~     toxicities are needed. Intensity modulated radiation therapy (IMRT) is an advanced method of~     delivering external beam radiation that may minimize the volume of normal tissue irradiated~     to high dose and thus decrease the risk of normal tissue toxicity. The proposed study will~     prospectively test whether IMRT is tolerable for delivering IMRT doses of 60 Gy for patients~     with esophagus cancer.~   "
226449|NCT00593710|"~     Marfan syndrome is a genetic disease of our connective tissue, which provides material and~     support for our skeleton, muscles, blood vessels and other parts of our bodies. People with~     Marfan syndrome may be tall and thin with slender, tapering fingers, long arms and legs, and~     spine curvature. They often have heart and eye problems. In some patients, the condition is~     very mild and the person has few or no symptoms. Others are always at risk of~     life-threatening problems, which usually involve damage to the valves in the heart or~     weakening of the large blood vessels leading from the heart. If the blood vessels become~     weak, they can balloon out (dilate) and break (rupture), which might cause the person to die~     suddenly. We have only a limited ability to stop the progression of disease in Marfan~     syndrome. Typically we use medicines that lower heart rate or blood pressure (or both). But~     this does not prevent the disease and very few drugs work well enough to keep patients from~     needing surgery or dying suddenly because a blood vessel has torn open. Our objective is to~     study two medicines to see if one, or both, can improve blood vessel function in patients~     with Marfan syndrome. One (Atenolol) belongs to a group of drugs called beta blockers and is~     often used to treat high blood pressure. It is the most common drug that is currently used to~     treat patients with Marfan syndrome. The other (Losartan) is also used for high blood~     pressure, but works in a different way. This study will help us to find better ways to treat~     people who have Marfan syndrome and to identify early changes in blood vessel function that~     may help to prevent long-term complications.~   "
226450|NCT00593697|"~     The purpose of the study is to compare disease-free survival (DFS) of women treated with~     concomitant trastuzumab plus docetaxel followed by FEC to that of the women treated with the~     same regimen followed by single-agent trastuzumab to complete one year of trastuzumab~     administration as adjuvant treatments of early HER2-positive breast cancer.~   "
226451|NCT00593684|"~     The purpose of this study is to test the safety of silver alginate (Algidex™) dressing in~     VLBW infants in preparation for a large efficacy trial.~   "
226452|NCT00593671|"~     In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to~     improve success rates after IVF, we test the hypothesis that patients with advanced maternal~     age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally~     normal embryos following PGS compared to patients who had an ET without PGS.~      In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per~     embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo~     biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without~     PGS.~   "
226453|NCT00593658|"~     The Hepatopulmonary syndrome (HPS) results from intrapulmonary microvascular dilatation that~     impairs arterial oxygenation in the setting of cirrhosis or portal hypertension. As many as~     10-20% of cirrhotics being evaluated for orthotopic liver transplantation (OLT) have advanced~     HPS and mortality is greater in those with HPS than in those without HPS. Currently, OLT is~     the only effective treatment, although post-operative mortality in HPS is increased relative~     to cirrhotic patients without HPS, with a one-year survival of between 68-80 %. Therefore, an~     effective medical therapy for advanced HPS could improve both pre-operative and~     post-operative mortality.~      Recent work in experimental models of HPS has revealed that both nitric oxide~     synthase-derived nitric oxide and heme oxygenase-derived carbon monoxide cause intrapulmonary~     vasodilatation. These alterations appear to be driven in part by TNF-α modulation of~     pulmonary blood flow and intravascular monocyte accumulation. Pentoxifylline is a nonspecific~     phosphodiesterase inhibitor with inhibitory effects on TNF-α and has recently been shown to~     be beneficial in patients with severe alcoholic hepatitis where TNF-α overproduction~     contributes to liver injury. In experimental HPS, pentoxifylline administration also~     decreases the severity of oxygenation abnormalities. However, pentoxifylline therapy has been~     associated with dose limiting side effects in patients with liver disease and the~     tolerability of pentoxifylline in cirrhotic patients with advanced HPS is unknown. Therefore,~     this open label single arm clinical trial was designed to evaluate the efficacy and~     tolerability of 8 weeks of pentoxifylline in cirrhotic patients with advanced HPS being~     considered for OLT.~   "
226454|NCT00593645|"~     This study will test the combination of clofarabine, cytarabine, and thymoglobulin as a~     non-myeloablative conditioning regimen for patients with myelodysplastic syndromes or acute~     myeloid leukemia undergoing allogeneic stem cell transplant.~   "
226455|NCT00593632|"~     The study evaluates high fiber diet intake in patients with hyperlipidemia.~   "
226456|NCT00593619|"~     The purpose of this trial is to compare the safety profile using equal doses of intravenous~     iron dextran versus iron sucrose. The researchers hypothesize that significantly more~     patients receiving intravenous iron dextran (using the current intermediate molecular weight~     product) will have severe adverse outcomes than patients receiving iron sucrose in the adult~     non-hemodialysis outpatient population. Secondly, since these severe reactions may require~     additional nursing time and physician interventions that may negate any cost advantage of~     iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than~     iron dextran.~   "
226457|NCT00593606|"~     This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of~     switching from ropinirole therapy to the rotigotine transdermal system and its effect on~     symptoms in subjects with idiopathic Parkinson's disease~   "
226458|NCT00593593|"~     This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after~     treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case~     a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).~   "
226459|NCT00593580|"~     Women who undergo bilateral oophorectomy and receive chemotherapy are at risk of increased~     bone loss. At present, despite having a risk factor profile that fits the indications for~     assessment and treatment there are no routine interventions in this patient population i.e.,~     the standard treatment is no treatment. We hope to identify whether or not an intervention~     may be favorable in these women and change the standard of care in this vulnerable~     population.~      Hypothesis:~      Weekly therapy with alendronate + vitamin D (FOSAVANCE) will improve bone health as measured~     by DEXA scans in women with gynecologic malignancies undergoing chemotherapy as compared with~     patients receiving placebo.~   "
226460|NCT00593567|"~     The purpose of this study is to determine whether the gentamicin-collagen sponge when~     combined with standard of daily wound care is safe and effective in treating mildly infected~     skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily~     wound care.~   "
226463|NCT00593528|"~     Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the~     treatment of complications of portal hypertension in patients with cirrhosis.~      The initial experiment of the TIPS was reported during the 1990s with stents of various~     brands, manufacture and sizes, but all non covered, thus owing the pseudointimal~     hyperplasia growing inside the stent, which progressively decreases the diameter of the shunt~     and thus its efficacy. Since the beginning of the 2000s, appeared stents known as covered~     by polytetrafluoroethylene (PTFE) designed to reduce the obstruction rate and thus the~     frequency shunt revisions. However, these stents are, on average, 2.5 times more expensive~     than the non covered stents and the cost-effectiveness ratio of the TIPS according to the~     type of stents used has not been assessed.~      The aim of this multicentric and randomized study is to assess the cost-effectiveness ratio~     of these 2 principles of TIPS, the one using stents covered by PTFE, relatively expensive but~     seldom becoming obstructed, and the other using non covered stents, less expensive than PTFE~     but requiring regular gestures of redilatation.~      Population concerned: Patients with a cirrhotic portal hypertension responsible for:~        -  recurrent variceal bleeding~        -  refractory ascite (or hydrothorax)~   "
226464|NCT00593515|"~     Does parenting style affect emotion regulation among children who initially demonstrate high~     levels of fear and anxiety? Although recent correlational research has demonstrated a linkage~     between parental behaviors, such as excessive intrusiveness, and children's manifestations of~     fear and anxiety, it is not clear if parenting behaviors directly influence children's~     ability to regulate these emotions. Alternatively, these parental behaviors may be elicited~     by children who express fears and anxieties more frequently than other children do.~     Experimental research designs would offer a more definitive test of these competing~     explanations of the extant correlational findings. Intervention studies, in particular, can~     test whether experimentally manipulating current family interaction patterns affects~     children's ability to regulate emotion. This study provides a preliminary experimental test~     of the relationship between parental behavior and children's regulation of fear and anxiety.~     Some 40 clinically anxious youth, aged 6-13, were randomly assigned to a family intervention~     program for childhood anxiety problems, which includes extensive parent communication~     training, or a child intervention program without parent-training. By comparing these two~     interventions, we tested if it was possible to improve parenting behaviors—such as~     intrusiveness—through intensive parent-training, above and beyond the effects of involving~     children in a child intervention program. We then tested the impact of this change in~     parental behaviors on children's ability to regulate fear and anxiety. We hypothesized that~     parent-training would reduce intrusiveness, which would in turn improve children's anxiety~     outcomes.~   "
226465|NCT00593502|"~     The main purpose of this study is to assess the efficacy of early oseltamivir treatment~     (started within 24 hours of the onset of influenza symptoms) in preventing the development of~     acute otitis media as a complication of influenza in children aged 1-3 years.~   "
226466|NCT00593489|"~     Family Physicians, the subjects of this trial are reluctant to initiate insulin in patients~     with type 2 diabetes due to a lack of familiarity and comfort with this clinical strategy.~     This study will test the effectiveness of diabetes specialist consultation support, and~     community pharmacy insulin initiation support on the insulin prescribing behaviour of family~     physicians across Canada.~   "
226467|NCT00593476|"~     The purpose of this trial is to study the safety and efficacy of a pre-packaged, portion~     controlled meal plan on weight loss and glycemic control in overweight and obese patients~     with type 2 diabetes.~      Aim 1 - Effects on Weight Assess the effects of a pre-packaged, portion controlled meal plan~     on weight loss in overweight and obese patients with type 2 diabetes.~      The researchers hypothesize that the pre-packaged, portion controlled diet (PCD) will produce~     a greater weight loss than a diabetes support and education (DSE) program at 12 weeks. The~     study will be powered to detect between group differences of 3% of body weight. Secondarily,~     the researchers will assess whether there are any differences in weight during the secondary~     phase from weeks 13-24 when both groups will consume a PCD diet.~      Aim 2 - Effects on Glycemic Control~      Assess the effects of a pre-packaged, portion controlled meal plan on glycemic control in~     overweight and obese patients with type 2 diabetes.~      The researchers hypothesize that the PCD will show greater improvement in HbA1c levels than a~     DSE group at 12 weeks. The study will be powered to detect between group differences of .5%~     in HbA1c. Secondarily, improvements and differences in HbA1c from weeks 13-24 when both~     groups are consuming a PCD will be assessed.~   "
226468|NCT00593463|"~     This study involves giving psychoactive drugs intramuscularly (injected into the muscle of~     the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the~     difference between one drug and another, as well as measuring the effects of the drugs on~     mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each~     subject will receive 2-4 of the listed interventions.~   "
226469|NCT00593450|"~     The purpose of the study is to evaluate the relative efficacy and safety of treatment of~     neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a~     variable schedule, and Avastin on a variable schedule.~      A five year follow-up visit is being conducted in 2014 to gather information on long term~     outcomes.~   "
226470|NCT00593437|"~     Differences in determining bone density scores have been found when comparing different bone~     density machines. Reducing differences between machines will improve diagnostic agreement for~     patients measured at different clinics. This study will test if this difference exists~     between the Norland Excel, such as the one at Wildwood Clinic, and the GE Healthcare Lunar~     Prodigy at the UW Osteoporosis Clinical Research Center.~   "
226471|NCT00593424|"~     The study examines the effect of two diets on fasting and post fat load lipoproteins of~     subjects with type 2 diabetes with moderate hypertriglyceridemia.~   "
226496|NCT00593099|"~     The purpose of this pilot study is to determine the safety and potential efficacy of~     sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients~     with bipolar affective illness. It is hypothesized that bupropion will produce a significant~     enhancement of smoking abstinence compared to placebo and will be safe for use in these~     patients.~   "
226497|NCT00593086|"~     To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn~     patients experiencing severe procedural pain during wound care.~   "
226472|NCT00593411|"~     The collection of data from the myriad of services described is significantly impacted by NIH~     guidelines defining medical research involving humans as well as the recent implementation of~     HIPAA constraints which further complicate the conduct of retrospective clinical outcomes~     research. Simple case reports or case series analysis now involve IRB participation as well~     as voluminous documentation.~      The solution to this dilemma lies in developing and promoting secure, confidential~     prospective clinical databases for storing clinical data for subsequent retrospective~     de-identified inquiry. These databases function in a way analogous to tissue banks for~     subsequent basic science research. Patients consent to prospective entry of their clinical~     information into the database so long as they continue to be a patient with the Department of~     Neurological Surgery or the Departments or Divisions in association with the affiliated~     programs briefly described above. The consent is obtained during the patient's first~     inpatient or outpatient encounter in parallel with the HIPAA consent. It can be withdrawn by~     request of the patient at any time, but it does not expire unless the patient withdraws it,~     or the patient severs their patient care relationship with UCI Neurosurgery or the affiliated~     programs. The database is stored on a separate secure server maintained and backed up by the~     UCIMC Information Technology Department. Access to the database is restricted at multiple~     levels, with the majority of personnel allowed only limited access for data entry purposes.~     Only the database programmer/coordinator, the Department Administrator and the Chairman of~     the Department will have unrestricted access to the database. Authority for permission for~     levels of security clearance and access to the database, for other individuals, will be~     vested in the Chairman of the Department of Neurological Surgery.~      A separate IRB proposal will be formulated for individual study related to the acquisition of~     data from the de-identified database. Since these future studies will be performed on data~     sets derived from the previously consented subjects of this IRB-approved project, the~     requirement for additional consent forms are not anticipated. As a result IRB research~     proposals utilizing the database can be expedited. Once the specific study is approved, the~     investigator(s) are provided with the clinical information from the database in the form of a~     de-identified data set.~   "
226473|NCT00593398|"~     Malaria is caused by a parasite and is a health problem for mothers and fetuses (unborn~     infants). The Cameroonian Ministry of Health recommends that all pregnant women should take~     the drug sulfadoxine-pyrimethamine (also known as SP) every two months during pregnancy to~     avoid malaria. The purpose of this study is to find out how effective SP is in preventing~     pregnant Cameroonian women from getting malaria. Additional goals of this study are to see~     whether: SP prevents malaria parasites from causing changes in the placenta; SP prevents or~     helps women make a substance that keeps parasites from accumulating in the placenta; and~     whether SP affects the amount of protection a mother transfers to her baby. Participants will~     include 1,160 pregnant women, ages 15-50 years, and 216 babies born residing in Ngalii II and~     Ntouessong. Study procedures will include monthly blood samples from pregnant women and~     babies. Volunteers may participate in this study for up to 19 months.~   "
226474|NCT00593385|"~     Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and~     effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic~     claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in~     the common and/or external iliac artery.~   "
226475|NCT00593372|"~     The purpose of this study is to collect data on the effects of behavioral interventions for~     memory and communication deficits in persons taking cholinesterase inhibitors compared with~     the effects of cholinesterase inhibitors alone. Initial testing will include a written case~     history, tests of communication skills, and interviews with the participants, family, and~     staff caregivers to help select potential goals for treatment. Participants will be randomly~     selected to participate in Group A (control) or Group B (intervention). Group A will use a~     Caregiver Checklist for eight weeks to identify any increase or decrease in the occurrence of~     the identified communication deficits. Group B will have 16 treatment sessions by a Speech~     Language Pathologist during the eight-week period. A post test will be administered to all~     participants.~   "
226476|NCT00593359|"~     This study will compare the effect of two intravenous solutions on eye pressure during spine~     surgery in the following groups:~      Group A - Lactated Ringer's replacement for blood loss and placebo eye drops~      Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops~      Group C - Albumin replacement for blood loss and placebo eye drops~      Group D - Albumin replacement for blood loss and brimonidine eye drops~   "
226477|NCT00593346|"~     Over the past two decades, breast conserving therapy (BCT) has become a major treatment~     modality for Stage I and II breast carcinoma. The major advantages of breast conserving~     therapy are superior cosmetic outcome and the reduced emotional and psychological trauma~     afforded by this procedure compared with conventional mastectomy. The principal disadvantage~     of BCT is its more complex and prolonged treatment regimen requiring approximately 6 weeks of~     external beam radiation therapy that poses problems for some patients such as the working~     woman, elderly patients, and those who live at a significant distance from a treatment~     center. These factors, along with the patient's geographic location, result in a smaller~     fraction of the patients who currently meet eligibility criteria for BCT actually receiving~     it, despite its cosmetic and probable psychological advantages. The logistical problems of~     BCT are primarily related to the protracted course of external beam radiation therapy to the~     whole breast. While some investigators reported what they believe to be acceptable local~     control rates in carefully selected patients treated by wide local excision without radiation~     therapy, the criteria for patient selection are controversial and poorly defined and probably~     restrict the access of many patients to breast conserving therapy.~      If previous observations are valid and breast irradiation following tylectomy exerts its~     maximal effect in eradicating occult disease remaining in the immediate vicinity of the~     tylectomy site, can radiation therapy be directed only to the tissue surrounding the excision~     cavity of the breast, using brachytherapy alone? If so, the entire course of radiation~     therapy could be delivered over a 4 to 7 day period immediately following tylectomy and/or~     axillary dissection, thus markedly reducing treatment time. Brachytherapy also inherently~     provides a higher central dose to the volume most at risk for recurrence. Cosmetic outcome~     after the use of a brachytherapy boost after external whole breast radiotherapy is comparable~     or slightly inferior to electron beam boost radiation therapy~   "
226478|NCT00593333|"~     This project is designed to determine whether or not the trochanteric insertion portal will~     show any difference when compared with the piriformis fossa portal in terms of pain and~     strength of the hip abductor muscles, while allowing faster surgical fixation of the femur~     fracture.~   "
226479|NCT00593320|"~     This study will evaluate the most effective radiation dose. Patients will be randomized (like~     flipping a coin) to receive either low dose stereotactic radiotherapy (defined as 14 Gy) or~     high dose stereotactic radiotherapy (defined as 18 Gy).~   "
226480|NCT00593307|"~     The overall objective is to investigate the effects of low and high glycemic index (GI) meals~     varying in protein content on plasma glucose and insulin response, subjective ratings of~     hunger, and subsequent food intake in twenty healthy, sedentary, overweight and obese men and~     women between the ages of 21-65.~   "
226481|NCT00593294|"~     Oral contraceptive therapy is routinely used for the treatment of menstrual disturbances of~     patients with polycystic ovary syndrome (PCOS).~      To date, the cardiovascular risk (CVR) of the oral contraceptives (OC) are known but no data~     are available on the CVR in PCOS patients treated with OC or physical exercise.~      The purpose of this study is to compare the effects of OC to physical exercise on the CVR of~     PCOS women and show the hormonal and metabolic effects of these two different treatment.~      We hypothesize that physical exercise has the same beneficial effects of OC therapy on~     hormonal and metabolic features of PCOS women with less cardiovascular consequences.~   "
226482|NCT00593281|"~     Double-blind study comparing the pharmacokinetics, safety and tolerability of morphine~     administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX)~     and intravenously conducted in patients in a hospice care setting or through a palliative~     care medicine setting. In this within-patient controlled study, each eligible study patient~     receives a single injection by each of the three methods of morphine administration,~     sequentially on three consecutive days, according to the order specified by a randomization~     schedule.~      Each of the three injections consists of 5 mg of morphine (1.0 mL of 5 mg/mL solution). The~     HYLENEX injection will be 1 mL of 150 units. Although the IV administration will not be~     blinded, the two SC injections will be double-blinded, using the same volume of normal saline~     (0.9% sodium chloride) placebo (1.0 mL) as HYLENEX.~   "
226483|NCT00593268|"~     In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt~     Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain~     aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser~     directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid~     and blood will then be analysed for different biological markers, protein expression and gene~     expression. These markers will then be statistically correlated with clinical data including~     prediction of vasospasm, time to vasospasm and response to standard therapy.~   "
226484|NCT00593255|"~     This trial is conducted in Asia. The aim of this trial is to compare the efficacy of~     postprandial plasma glucose of two treatment regimens in Chinese subjects.~   "
226485|NCT00593242|"~     This is a pilot study to test feasibility of collection, preparation and infusion of a baby's~     own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born~     with signs of brain injury.~   "
226486|NCT00593229|"~     This registry will collect clinical data and store biosamples (seru, plasma, urine, and DNA)~     annually from pediatric patients with thrombotic mcroangiopathy~   "
226487|NCT00593216|"~     The purpose of this study is to determine the potential usefulness of new functional MRI in~     diagnostic assessment of patients presenting with vertigo.~   "
226488|NCT00593203|"~     The Molecular Neurosurgical Tissue Bank will function as a tissue or specimen repository for~     biopsy specimens from patients (both adult and pediatric) undergoing brain surgery and brain~     procedures. Leftover tissue removed during the course of brain surgery will be collected and~     stored in neurosurgical laboratories for use in medical research that might be currently~     ongoing or for future research. In addition, blood and cerebral spinal fluid samples will~     also be collected and stored. Leftover cerebral spinal fluid (CSF) will be collected during~     standard of care procedures (lumbar punctures or ventricular drains) that take place at time~     of diagnosis, completion of therapy and relapse of disease or during neurosurgery. Blood will~     be drawn at time of routine lab draws required during the surgery or procedure.~   "
226489|NCT00593190|"~     Intracameral Gas SF6 (Sulfur Hexafluoride) Injection for Acute Hydrops in Keratoconus~   "
226490|NCT00593177|"~     The primary objective of the study is to assess the tolerability and efficacy of a 0.10% or~     0.05% PTH (1-34) parathyroid hormone peptide gel in the treatment of mild to moderate plaque~     psoriasis in comparison to treatment with the placebo gel alone.~   "
226491|NCT00593164|"~     This study will involve the use of therapeutic hypothermia. This prospective cohort pilot~     study will evaluate the clinical performance of a new device, the ThermoSuit™ System, to~     achieve therapeutic hypothermia in comatose patients following resuscitation from cardiac~     arrest, and the impact of the vasodilator, magnesium sulfate, on cooling performance and~     hemodynamics in these patients. The study hypothesis is that magnesium sulfate will~     significantly increase the rate of cooling.~   "
226492|NCT00593151|"~     The purposes of the PLUS study were to confirm the safety and tolerability of two doses of~     LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior~     anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability,~     and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in~     treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All~     subjects were also to receive oral daily weight-based ribavirin.~   "
226493|NCT00593138|"~     The objectives of this study are to document the pharmacokinetics of the adequacy of DAT~     receptor occupancy d-MPH formulation in three doses (20 mg, 30 mg, and 40 mg) using PET~     scanning with C-11 Altropane as the ligand across a range of times. It has been estimated~     that MPH is effective when the average CNS DAT occupancy is 50% or greater. Focalin XR has~     been shown to be clinically effective in an analog classroom as early as 1 hour and as late~     as 12 hours. Therefore, it is hypothesized that the average DAT occupancy will be adequate~     (50% or greater) at time periods corresponding to the times of clinical efficacy.~      The first objective is to examine the onset of action by testing whether average DAT~     occupancy will be adequate (50% or greater) at 1 hour after dosing for each dose tested (20~     mg, 30 mg, 40 mg).~      The second objective is to test the adequacy of average DAT occupancy in a range of later~     times for each dose. The times chosen (8, 10 and 12 hours) correspond to times Focalin XR has~     been shown to be clinically effective in an analogue classroom study. A range of times have~     been chosen since, while effective at 12 hours, the degree of clinical effectiveness~     decreased with later time periods. The adequacy of DAT occupancy across this range of time~     periods will provide important details on the in vivo molecular action of the medicine at~     periods of critical clinical activity.~      The third exploratory objective is to examine a time period later then those previously~     tested with the highest dose. Since the clinical effectiveness of Focalin XR has not been~     tested out to 14 hours, it is unknown whether it is effective at 14 hours. If Focalin XR were~     to be effective at 14 hours it would be more likely at the highest dose.~   "
226494|NCT00593125|"~     The proposed investigation will use methadone maintained patients who have concurrent cocaine~     dependence in order to take advantage of the excellent (over 80%) treatment retention in this~     patient group and to maximize treatment compliance by daily observed medication with both~     methadone and levetiracetam. In the initial patients we will explore the tolerability of~     escalating doses of levetiracetam as well as its potential role in reducing cocaine use, as~     monitored by self-report and verified by three-times weekly urine toxicology testing in~     methadone treated patients.The specific aim of this study is to evaluate the tolerability and~     efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine~     craving and attenuating cocaine's reinforcing effect among methadone-maintained patients~   "
226498|NCT00593073|"~     Effective programs are needed that can overcome barriers to CRC screening among persons in~     rural communities. There is good evidence to suggest that a program employing patient~     activation and tailoring to address the specific concerns of individuals will be an effective~     model for addressing CRC screening underutilization for rural residents. In this study, we~     propose to test such a model among rural primary care patients, a group that has, to date,~     received little attention. We will also bolster how tailored messaging is traditionally~     conducted by using a tailored informational flyer format that uses physicians as the message~     source to increase message saliency. This study will help to assess how a relatively~     low-cost, disseminable technology can effectively circumvent the systems problems endemic~     in rural primary care. This project will lay the groundwork in practice based research~     network clinics for future intervention studies which operationalize office and~     community-based technology to help rural primary care patients make informed health decisions~     and engage in healthy lifestyle behaviors.~   "
226499|NCT00593060|"~     In this study, the investigational drug, temsirolimus, will be combined with cetuximab, a~     biologic agent used in the treatment of colorectal cancer. Cetuximab in combination with~     temsirolimus may be more effective in treating advanced colorectal cancer than cetuximab~     alone. The purpose of this research study is to try to define the highest dose of cetuximab~     that can be used safely in combination with temsirolimus to treat advanced colorectal cancer~     that has progressed through standard therapy.~   "
226500|NCT00593047|"~     Thyroid hormones are known to reduce cholesterol levels through regulation of a number of key~     enzymes involved in synthesis, degradation, and lipid transport. However, the currently~     marketed thyroid agonists are non-selective, and cannot be used for the treatment of~     hypercholesterolemia due to extrahepatic consequences of hyperthyroidism, especially on~     heart, bone, and muscle.~      To take advantage of thyroid hormone effect on lipid metabolism for the treatment of~     hypercholesterolemia, it is necessary to develop a selective thyroid receptor agonist that~     can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the~     extrahepatic tissue. KB2115 is a thyroid agonist developed to be liver selective.~      The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to~     low and middle doses of statin following 12 weeks of exposure compared to placebo. The aim of~     the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 at~     doses between 25 and 100 µg and to define a clinically relevant dose or dose range for future~     studies.~   "
226501|NCT00593034|"~     This study will use the CCPT II to assess attention in 12-21 year olds enrolled in a~     randomized controlled trial of a brief behavioral treatment for substance abuse.~      This study will describe at baseline levels of attention using a well validated instrument~     (Connors Continuous Performance Test II) and explore the association between attention levels~     and substance use. The primary study hypothesis is that lower initial levels of substance use~     (as measured by percent days abstinent) will be associated with higher attention levels. We~     envision that this data will inform a better understanding of how attention may modify~     treatment response.~   "
226502|NCT00593021|"~     Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by EGD~     and colonoscopy, the presumed source of bleeding in these patients being the small intestine.~     These patients fall under the category of obscure gastrointestinal bleeding, and frequently~     require an extensive diagnostic work-up. For these reasons, most patients who present with~     obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic~     evaluations, including capsule endoscopy and various radiologic imaging studies, including~     enteroclysis, small bowel series, CT scan, angiography, and radionuclide scan. Recently, many~     centers (included the Brigham and Women's Hospital) have begun using capsule endoscopy and CT~     enterography (CTE) for evaluation of suspected small bowel pathology. This is an~     observational study enrolling patients referred to the Brigham and Women's Hospital for~     obscure gastrointestinal bleeding designed to compare the diagnostic yield of various~     diagnostic modalities, in particular capsule endoscopy and CT enterography in the evaluation~     of obscure gastrointestinal bleeding.~   "
226503|NCT00593008|"~     The purpose of this research study is to try to define the highest doses of temsirolimus and~     gemcitabine that can be used safely in combination to treat advanced pancreatic cancer.~     Gemcitabine is a standard chemotherapy used for the treatment of pancreatic cancer.~   "
226504|NCT00592995|"~     PRECREST is a two phase protocol for Huntington's disease in which 60 premanifest and at-risk~     subjects will first be randomized into a double blind placebo controlled dose titration study~     bringing them to 30 grams daily or their highest tolerated dose. This phase will establish~     the highest tolerable doses in premanifest HD and permit the detection of toxicity and~     intolerability with attribution to active compound versus placebo, and enable a dose response~     assessment of biomarkers. In the second phase, all subjects will enter a year long open-label~     treatment on 30 grams daily (or their highest dose) of creatine to assess long term exposure~     to high dose creatine and its long term impact on various biomarkers.~   "
226505|NCT00592982|"~     1. Bisphosphonate-associated osteonecrosis of the jaw(ONJ)is detectable by positron~          emission tomography(PET).~        2. Bisphosphonate-associated ONJ can be diagnosed and characteristically differentiated~          from other bony pathologies of the jaw(osteomyelitis, osteolytic lesions, and~          osteoradionecrosis)by PET imaging.~   "
226506|NCT00592969|"~     This trial is conducted in South America. The aim of this trial is to evaluate the efficacy~     of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects~     with type 2 diabetes.~   "
226507|NCT00592943|"~     The specific aims of this study are 1) to document the Dopamine Transporter (DAT) receptor~     occupancy of armodafinil using positron emission tomography (PET) scanning with C-11~     altropane as the ligand and 2) to document the increased intrasynaptic dopamine produced by~     armodafinil using PET scanning with C-11 raclopride as the ligand. We hypothesize that DAT~     occupancy will be low with armodafinil; less than the DAT occupancy produced by therapeutic~     doses of methylphenidate. We also hypothesize that increases in intrasynaptic dopamine will~     be relatively low with armodafinil.~   "
226508|NCT00592930|"~     This study compared 10 weeks of treatment with olanzapine versus placebo in adolescent~     females with anorexia nervosa-restricting type who were undergoing acute treatment on an~     inpatient unit or a day hospital program that specializes in the treatment of eating~     disorders.~   "
226512|NCT00592865|"~     Study Objective:~      Brain tumors are poorly understood. The purpose of this research is to examine whether~     factors in lifestyle play a role in brain tumor development. The study will also investigate~     the contribution of inherited susceptibility to the risk of brain cancer. By gaining a better~     understanding of these influences, the investigators hope to learn how to prevent brain~     tumors in future generations, and to develop more effective strategies for treatment.~      Study Protocol:~      This is a case-control investigation. Persons affected with a brain tumor are compared to~     unaffected persons on previous medical history, diet and other factors. Those enrolled in the~     study will participate in an interview on general background, diet, medical history and~     lifestyle, and will provide a sample of DNA, clippings of your toenails, and a tap water~     sample from your home. All procedures are performed in the clinic or through the mail.~      'Cases': Cases eligible for the study are persons with a recent diagnosis of a primary brain~     tumor (glioma or meningioma), at least 18 years of age.~      'Controls': Controls in the study are non-family members of patients, similar in age and of~     the same gender. Suitable controls include in-laws, friends, neighbors and co-workers.~   "
226513|NCT00592852|"~     This will be a 12-week open-label pilot treatment study for children and adolescents (ages~     6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder~     (OCD) who are adequately mood stabilized on a stable regimen based on standard clinical care.~     Specific hypotheses are as follows:~      Hypothesis 1: Children and adolescents with comorbid OCD and BPD who have achieved adequate~     mood stabilization using a naturalistic clinical practice approach, will benefit from an~     FDA-approved selective seratonin reuptake inhibitor (SSRI) on their OCD symptoms in a~     clinically meaningful way without exacerbation of bipolar symptoms.~   "
226514|NCT00592839|"~     This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor~     symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening~     period and approximately 5 scheduled clinic visits. Participants will receive one of two~     strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical~     and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a~     pap smear. Participants will be asked to wear a monitoring device for a portion of the study~     and be asked to complete a daily dairy.~   "
226515|NCT00592826|"~     The study is divided in two stages. The purpose of the first stage is to evaluate the~     percentage of subjects that can unpack the device, install it, learn the task and calibrate~     it according to their personal capabilities. The purpose of the second stage is to assess the~     ability of the subjects to perform reliable tests .~   "
226516|NCT00592813|"~     Background:~      Many people who have suffered a hip fracture are discharged from rehabilitation services with~     significant residual functional limitations and disability. We believe that a home-based~     exercise program that incorporates cognitive-behavioral techniques to increase exercise~     adherence and promote the return to daily activities could extend the benefits of formal~     rehabilitation for patients who have suffered a hip fracture.~      Specific Aims:~      We will conduct a 5-year multi-site randomized controlled trial in patients who have suffered~     a recent hip fracture and have completed all rehabilitation services. The specific aim that~     this project will address is whether:~      Participation in the Strong for Life (SFL) program will improve function and disability~     outcomes in participants 6-months after they are discharged from rehabilitation services.~      This study will also investigate the following secondary hypotheses:~        1. Changes in function and disability at 6-month follow-up will be correlated with changes~          in all three proposed intermediary variables: muscle strength, balance, and~          self-efficacy.~        2. The SFL program will significantly improve health-related quality of life among~          participants at 6-month follow-up.~        3. At 9-month follow-up the SFL program will continue to have a significant impact on~          participants' function and disability compared to the control group.~      Target population:~      The target population will be people aged 60 years or more who have suffered a recent~     traumatic hip fracture, have one or more residual functional limitations and have completed~     all inpatient, outpatient or homecare rehabilitation services.~      Intervention:~      We will use an enhanced version of the Strong for Life program. This home-based exercise~     program will include both resistance exercises using Thera-bands that will be shown on a~     video/DVD and weight-bearing exercises that are progressed using a step and/or a weighted~     vest. A cognitive-behavioral program that is customized for people recovering from hip~     fracture is being developed that will focus on promoting exercise adherence, decreasing fear~     of falling and increasing the return to daily activities in the patient's home and community.~      Design:~      A randomized controlled clinical trial will be implemented to measure the efficacy of the~     Strong for Life program. An attention-control intervention will be provided to all~     participants assigned to the control group. The outcome evaluation points are:~        -  T0: baseline, at the point of discharge from formal rehabilitation;~        -  T2: 6-month outcome assessment~        -  T3: 9-month follow-up~      Outcomes:~      The primary outcomes will be function measured by both self-report (AM PAC) and physical~     performance measures (SPPB). Secondary outcomes include disability, self-efficacy, balance,~     strength, cognition, and reaction time. Adherence to the exercise program and adverse events~     will also be monitored.~   "
226517|NCT00592800|"~     To make medical decisions involving pros and cons, one also has to understand probability and~     percentages. This is a preliminary study to evaluate the ability of children to understand~     probability and percentages.~   "
226518|NCT00592774|"~     The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in~     patients with Post-Herpetic Neuralgia (PHN).~   "
226519|NCT00592761|"~     The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver~     on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs~     of pharyngeal dysphagia.~   "
226520|NCT00592748|"~     The primary purpose of this study is to determine if the administration of a higher dose~     would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with~     a lower dose. Most of the treatment will be given protons, but participants may receive a~     small portion of treatment with x-rays, because less radiation is given to the skin with~     x-rays. This study uses two slightly different doses of radiation It is not clear at this~     time which of the dose levels is better.~   "
226521|NCT00592735|"~     This study will follow ,morbidly obese subjects as they undertake weight loss before and~     after laparoscopic gastric banding, examining markers of glucose and lipid metabolism,~     adipokines and measures of body fat.~   "
226522|NCT00592722|"~     To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI~     therapies in forthcoming randomized controlled multi-centre clinical trials following~     international standards and guidelines~   "
226523|NCT00592709|"~     We are collecting brain tissue specimens and blood samples from patients at Vanderbilt~     University Medical Center who are undergoing intracranial surgery to remove brain tissue,~     including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery~     for other non-cancerous types of brain tissus. These specimens will then be studied using a~     novel microscopic laser-directed protein mass spectrometric analysis, looking for unique~     protein signatures.~   "
226549|NCT00592371|"~     Head and Neck Squaumous Cell Cancer(HNSCC) is the 6th most common cancer in the United States~     and the 3rd most common worldwide. Risk factors include abuse to tobacco and alcohol.~     Survival is related to stage of HNSCC when treatment is sought. Most HNSCC patients present~     with advanced staged disease. This screening activity will educate patients with HNSCC rick~     factors and screen for pre malignant and/or early staged lesions.~   "
226524|NCT00592696|"~     It has been shown in the adult literature that smoking is related to depression and visa~     versa. Not much is known about how this relationship is started or if one perhaps leads to~     the other. We are performing 1 hour long interviews with adolescents ages 12-19 who meet~     criteria for major depression and who smoke. They are interviewed along with their parent.~     Questions center around their view of depression and their history of depression as well as~     questions around their smoking as well as the interrelationships between the two. Transcripts~     are made of the interview and are being analyzed for themes.~   "
226525|NCT00592683|"~     This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to~     open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV~     criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as~     follows:~      Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of~     children and adolescents with BPD~      Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active~     omega-3 treatment~   "
226526|NCT00592670|"~     It is unclear what effect selective serotonin reuptake inhibitors (SSRIs) have on~     hypoglycemia. Thus, the American Hospital Formulary Service recommends careful monitoring of~     blood glucose levels in all patients with diabetes initiating or discontinuing SSRIs (Katz et~     al., 1996). Because of the increased prevalence of depression in those with diabetes, it is~     critical to discover what affect the antidepressant therapy may have on counterregulatory~     responses to hypoglycemia. This study hypothesizes that chronic administration of SSRIs may~     result in a blunted counterregulatory response to hypoglycemia, thereby leaving individuals~     more susceptible to hypoglycemia.~   "
226527|NCT00592657|"~     Retrospective chart review to determine the presence of rhabdomyolysis among patients~     admitted to CHMCA from 1997-2007 with Jimsonweed ingestions and to define possible risk~     factors predisposing patients to the developement of Jimsonweed-associated rhabdomyolysis.~   "
226528|NCT00592644|"~     Small vascular malformations (SVM) on the vocal fold is a common problem that can disturb the~     voice. The pulsed dye laser (PDL) has been successfully used for treatment of blood vessel~     abnormalities in surface tissue, through its high selectivity for destroying targeted blood~     vessels while sparing normal tissue. However, there is no study to determine its clinical~     benefit for treatment of SVMs on vocal fords. In this proposed study, we plan to make such a~     determination.We will determine whether PDL will produce better and quicker voice improvement~     than the conventional surgeries, in 20 patients (10 cases of each group) with vocal fold SVM.~     We expect that this less invasive laser treatment will provide an ideal and excellent option~     for this disease.~   "
226529|NCT00592631|"~     We hypothesize that the nocturnal use of continuous positive airway pressure in adults and~     children with asthma will decrease airway reactivity.~   "
226530|NCT00592618|"~     Sleep studies in ESRD patients have identified increased prevalence of Sleep Apnea. Based on~     current knowledge, treatment aimed at reducing oxidative stress might improve Sleep Apnea in~     HD patients. The aim of our study is to investigate the effect of N-acetylsysteine on Sleep~     Apnea in HD patients.~   "
226531|NCT00592605|"~     Thyroid disease is more common among females and is increasing in incidence.~      Otolaryngology faculty members and residents will perform head and neck examinations as part~     of the subject's routine care. If the participant is noted to have thyroid disease, they will~     be asked if they would like to participate in the research portion by having approximately~     10cc's of blood drawn. Faculty and staff will complete a data collection sheet that will~     contain demographic and clinical data.~   "
226532|NCT00592592|"~     The main purpose of this study is to see if using proton beam radiation therapy instead of~     photon beam radiation therapy can reduce side effects from radiation treatment for~     rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most~     rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and~     passes through healthy tissue, encounters the tumor, then leaves the body through healthy~     tissue. A beam of proton radiation enters the body and passes through healthy tissue,~     encounters tumor, but then stops. This means that less healthy tissue is affected by proton~     beam radiation than by photon beam radiation.~   "
226533|NCT00592579|"~     The purpose of the study is to determine the safety and effectiveness of providing~     2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. Information~     regarding trough 2ME2 levels will also be collected.~   "
226534|NCT00592566|"~     Background: Pulmonary involvement in leptospirosis has been reported to be on the increase~     and is emerging as the main cause of death due to leptospirosis in many countries, including~     Thailand.~      Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone~     as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with~     leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.~   "
226535|NCT00592553|"~     Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It~     is caused by a mutation in the gene for dystrophin, a protein that is important for~     maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility~     that leads to weakness and loss of walking ability during childhood and teenage years. A~     specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of~     DMD/BMD in approximately 10-15% of boys with the disease. PTC124 is an orally delivered,~     investigational drug that has the potential to overcome the effects of the nonsense mutation.~     This study is a Phase 2b trial that will evaluate the clinical benefit of PTC124 in boys with~     DMD/BMD due to a nonsense mutation. The main goals of the study are to understand whether~     PTC124 can improve walking, activity, muscle function, and strength and whether the drug can~     safely be given for a long period of time.~   "
226550|NCT00592358|"~     This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the~     treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or~     Bipolar Spectrum Disorder. Specific hypotheses are as follows:~      Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar~     I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.~      Hypothesis 2: Invega -associated improvement in bipolar disorder symptomatology in children~     and adolescents will translate into improved functional capacities (neuropsychological,~     social, and occupational), as well as an increased quality of life throughout treatment.~      Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out~     rate and absence of major side effects.~   "
226536|NCT00592540|"~     Phosphoglycerate kinase (PGK) deficiency is a rare x-linked disorder characterized by~     hemolytic anemia, seizures, muscle fatigue, and progressive neurological dysfunction. The~     disease is caused by the deficiency of PGK, an enzyme required for ATP formation through the~     glycolytic pathway. PGK is an enzyme that is ubiquitous to all cells of the human body, but~     red blood cells, muscles, and nerve cells are most severely affected by the absence of PGK~     due to their reliance upon the glycolytic pathway. Mutations of the PGK gene are highly~     variable and result in diverse phenotypes, ranging from mild hemolytic anemia only to severe~     mental retardation and early death in childhood. The more severe phenotypes show progressive~     neurologic deterioration between infancy and adolescence.~      This is a 2 patient study aimed at studying the role of stem cell transplant in PGK~     deficiency. Because the disease is so rare, the study will be limited to the 2 sibling~     patients followed by our group, though it would be open to other participants who would meet~     inclusion/exclusion criteria if such presented to us. The objective of this study is to~     evaluate the feasibility and efficacy of stem cell transplants to treat patients with PGK~     deficiency, Amiens subtype.~   "
226537|NCT00592527|"~     This trial is conducted in Asia.~      The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as~     add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.~   "
226538|NCT00592514|"~     Specific Aim I: Determine absorption of iodine after oropharyngeal application of~     povidone-iodine 10% solution when used in head and neck surgery involving the upper~     aero-digestive tract.~      Specific Aim II: Measurement of iodine induced changes in thyroid function.~   "
226539|NCT00592501|"~     Photon beam radiation is the standard type of radiation used to treat nasopharyngeal~     carcinoma. Photon beam radiation enters the body and passes through healthy tissue,~     encounters the tumor and leaves the body through healthy tissue. Proton beam radiation has~     been shown to have the same effect on tumors as photon beam radiation but it enters the body,~     passes through healthy tissue, and encounters the tumor but then stops. This means less~     healthy tissue is affected by proton beam treatment than by photon beam treatment. The~     purpose of this study is to determine the effectiveness of proton beam radiation in treating~     nasopharyngeal cancer and reducing the acute and long-term side effects from the treatment.~     This study will also test to see if the sparing of the healthy tissue can improve quality of~     life~   "
226540|NCT00592488|"~     This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic~     shock requiring vasopressors.~   "
226541|NCT00592475|"~     To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic~     patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic~     response in patients with cirrhosis.~   "
226542|NCT00592462|"~     The objective of this pilot study is to develop and evaluate a whole body MRI technique for~     detecting cancer metastases. The whole body MRI will include T1-weighted and T2-weighted~     phase-sensitive MR imaging as well as diffusion weighted imaging of the whole body in~     multiple patient table stations.~   "
226543|NCT00592449|"~     Osteoarthritis (OA) is one of the most common diseases and one of the leading causes of~     disability in the world. People with OA frequently experience sleep disturbances, primarily~     due to pain. Although insomnia is a known consequence of OA, recent studies have shown that~     it may also worsen clinical pain by interfering with the body's responses to painful stimuli.~     This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing~     sleep disturbances, thereby reducing clinical pain in people with knee OA. The study will~     test whether improvement in clinical pain are mediated by changes in certain types of pain~     processing.~   "
226544|NCT00592436|"~     The objective of this protocol is to establish a comprehensive screening process to evaluate~     the eligibility of potential pediatric subjects for appropriate ADHD clinical research~     studies.~   "
226545|NCT00592423|"~     The primary aim of this study is to determine the changes in upper airway anatomy that occur~     during lateral neck rotation and subsequent administration of continuous positive airway~     pressure (CPAP) in anesthetized, spontaneously breathing children. The hypothesis for this~     study is that neck rotation decreases overall upper airway volume because of constriction at~     the level of the larynx, and that this constriction is relieved by administration of CPAP.~   "
226546|NCT00592410|"~     We propose to determine the acute metabolic effects of intensive insulin therapy when~     administered to AKI patients with a particular focus on its effects on protein metabolism. We~     hypothesize that the degree of insulin resistance correlates with protein catabolism in~     critically ill patients with AKI, and that intensive insulin therapy will result in~     substantial reductions in both whole-body and skeletal muscle protein breakdown thereby~     improving overall protein balance. We also hypothesize that this therapy will have favorable~     effects on the inflammatory and oxidative stress profile of patients with AKI. The metabolic~     response to these interventions will be assessed through stable isotope infusion techniques,~     allowing for the most precise assessment of protein and energy homeostasis.~   "
226547|NCT00592397|"~     The purpose of this pilot study is to optimize conditions for a planned human intervention~     study focusing on how diet predispose for, and influence, lifestyle disease development and~     its consequence in cardiovascular disease development.~   "
226548|NCT00592384|"~     Depression is likely the most prevalent and disabling psychological complication associated~     with spinal cord injury (SCI). Yet no controlled depression treatment trials have been~     performed in this population. The proposed study is a multi-site, randomized, double-blind,~     placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and major~     depressive disorder (MDD) or dysthymia who are at least one month post injury. Participants~     will be recruited from four SCI Model System sites, the University of Washington,~     Rehabilitation Institute of Chicago, University of Michigan, University of Alabama,~     Birmingham and Baylor Institute for Rehabilitation, Dallas, TX. The purpose of the study is~     to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The~     primary outcome will be the percent of responders (those who report at least a 50% reduction~     in depression severity from baseline to the end of treatment) in the venlafaxine XR versus~     placebo control group using intent-to-treat analysis. Secondary outcomes will include changes~     in pain, health related quality of life depression-related disability and community~     participation. A successful clinical trial could lead to more aggressive identification and~     treatment of MDD as well as improved health and quality of life in this important population.~   "
226551|NCT00592345|"~     The purpose of this study is to test the effectiveness of high dose radiation administered by~     both proton and photon therapy. Radiation is an effective treatment for many types of tumors~     and it is thought that radiation alone, when given in much higher doses over a shorter period~     of time, may be more effective in controlling recurrence of sarcoma.~   "
226552|NCT00592332|"~     Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.~   "
226553|NCT00592319|"~     Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical~     removal is the current management for RRP, but it is a very traumatic procedure, and often~     leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP~     treatment with a pulsed dye laser (PDL) and Celebrex. We will determine if Celebrex, a newly~     developed inhibitor of cyclooxygenase (COX)-2, can provide a long-term inhibitory effect on~     RRP, therefore preventing RRP from recurring. This combined strategy, if successful in this~     proposed study, will provide a new and ideal voice-preserving therapy for RRP that will~     deliver long-term efficacy in managing RRP.~   "
226554|NCT00592306|"~     The purpose of this study is to take a population of lung transplant recipients who meet UCLA~     criteria for induction chemotherapy with thymoglobulin and prospectively study weather giving~     the first dose intraoperatively versus postoperatively makes a difference with how patients~     do during and after lung transplantation.~   "
226555|NCT00592293|"~     The main purpose of this study is to assess the short term and the long term side effects of~     proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.~   "
226556|NCT00592280|"~     The purpose of this project is to compare the effect of oxygenated preservation of the~     pancreas before transplantation using the Two-Layer Method (TLM) against outcomes~     previously experienced with organs preserved using only standard University of Wisconsin (UW)~     storage solution. It is our hypothesis that TLM preservation will reduce the frequency and~     severity of complications of pancreas transplantation, increase the number of organs~     acceptable for transplantation, and spare individual patients and their families suffering~     and hardship.~   "
226557|NCT00592267|"~     The objective of this protocol is to establish a comprehensive screening process for the~     evaluation of eligibility for entry in a clinical trial program for children and adolescents~     with bipolar disorder.~   "
226558|NCT00592254|"~     The objective of this protocol is to establish a comprehensive screening process to evaluate~     the eligibility of potential adult subjects for appropriate ADHD clinical research studies~   "
226559|NCT00592241|"~     Diabetes mellitus (DM) is a multisystem disease with both biochemical and anatomical~     consequences. Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) is an~     attractive way of treating patients with diabetes. The NiliMedix ADI Insulin Pump is an~     ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous~     delivery of insulin.~      Insulin pumps require extensive user interaction because it is critical for treatment.~     Avoidance of use-related risks that could harm the patient or impact the quality of the~     treatment is important. Testing for ease and accuracy of use is the only way to ensure that~     users can safely and effectively operate, install, and program and maintain the insulin pump~     device.~   "
226560|NCT00592228|"~     Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow~     reserve-guided deferral strategy for these lesions showed the same event rate as routine~     intervention strategy. However, proper FFR criterion for these lesions in the era of~     drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of~     intermediate lesions according to FFR and compare those of FFR-guided intervention with~     routine drug-eluting stent implantation strategy.~   "
226561|NCT00592215|"~     A superior second trimester medical abortion regimen has not been identified. Studies suggest~     that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest~     median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of~     adverse events. Narrowing the interval between the two medications without clinically~     reducing effectiveness may increase access and acceptability for patients and reduce costs.~     Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between~     mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no~     studies on shorter intervals with same day administration between mifepristone and~     misoprostol in second trimester abortions.~      The primary objective is to assess the efficacy of the combined mifepristone/misoprostol~     regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8~     hours between the two medications.~   "
226562|NCT00592202|"~     The purpose of this study is to determine whether the LAP-BAND system is safe and effective~     in morbidly obese adolescents.~   "
226563|NCT00592189|"~     Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair~     safe and efficacious.~      Will the incorporation of liposomal gene constructs to amnion enhance the functionality of~     human amnion and improve wound repair.~   "
226564|NCT00592176|"~     The purpose of this study is to determine whether local injection of bevacizumab might halt~     and or cause regression of pterygium growth. This may enable earlier treatment and prevention~     of pterygium growth into the patient's line of sight thereby limiting the need for surgery~     and improving quality of life for patients with pterygia.~   "
226565|NCT00592163|"~     A Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas~   "
226566|NCT00592150|"~     Hypothesis to be tested: Dopamine D1-like receptor-induced natriuresis is impaired in humans~     with G protein-related kinase 4 gene variants.~      Our research group has discovered a D1 receptor/adenylyl cyclase coupling defect in renal~     PTCs from subjects with essential hypertension. We have found increased GRK-4 activity in~     renal PTCs in human essential hypertension due to activating variants of GRK-4, an effect~     that was reproduced in a transfected cell model. Preventing the translation of GRK-4~     normalized the coupling of the D1 receptor to adenylyl cyclase in hypertension. Gene variants~     of GRK-4 cause a ligand-independent serine-phosphorylation of the D1 receptor, resulting in~     its uncoupling from the G-protein/effector complex. The desensitization of the D1 receptor in~     the renal PTC is hypothesized to be the cause of the compromised natriuretic effect of DA~     that eventually leads to Na+ retention and hypertension. The primary objective of this~     protocol is to demonstrate that natriuresis engendered by D1-like receptor activation with~     fenoldopam is blunted in subjects with 3 or more SNPs of GRK-4 compared with responses in~     subjects with 0-2 SNPs.~   "
226567|NCT00592137|"~     Lifestyle choices,including diet,are conducive to healthy body weights in children. Dairy~     products and calcium supplementation have been associated with moderation of body weight and~     body fat. This study was designed to test the following hypotheses with overweight and obese~     adolescents consuming a controlled diet:~        -  Dietary calcium supplementation as calcium carbonate or dairy calcium modulates energy~          balance in adolescents.~        -  Increased calcium in the diet of adolescents will increase fecal fat excretion and~          thereby decrease fat absorption.~        -  Calcium and dairy product supplementation will increase lipid oxidation resulting in an~          increase in energy expenditure.~   "
226568|NCT00592124|"~     A new approach to HIV prevention currently being studied includes the use of microbicides,~     substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved,~     anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is~     to determine the adherence and acceptability to and blood levels of three daily regimens of~     tenofovir in both oral and gel form.~   "
226569|NCT00592111|"~     Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children~     and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment.~   "
226570|NCT00592098|"~     The objective of this study is to investigate the analgesic effect of topical strontium~     chloride in stump pain, and to prospectively determine other efficacy and safety measures of~     topical strontium chloride in stump pain.~   "
226571|NCT00592085|"~     The specific aims are to:~        -  Develop a Motivational Relapse Prevention Plus Alcohol Risk Reduction (MRP+) approach~          to simultaneously treating both smoking and at-risk alcohol use among smokers~          attempting to quit smoking.~        -  Estimate the effect size for MRP+ relative to Motivational Relapse Prevention without a~          focus on alcohol (MRP) with respect to alcohol at-risk behaviors. The estimated effect~          size will be utilized to help guide sample size estimates for a potential clinical~          trial.~   "
226572|NCT00592072|"~     At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood~     sugar) and its effects on long-term brain function. The aim of this study is to determine~     whether the human brain is able to use medium chain fatty acids (MCFA) and/or their~     metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1~     Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a~     rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during~     episodes of hypoglycemia (low blood sugar.)~   "
226573|NCT00592059|"~     The purpose of this study is to determine the therapeutic efficacy and complications of~     systemic consolidation therapy with paclitaxel plus carboplatin following radical~     hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.~   "
226574|NCT00592046|"~     This study uses a new investigational (not yet approved by the FDA for widespread use) drug~     called ZIO-101, an organic arsenical. You must be diagnosed to have relapsed/refractory~     leukemia or lymphoma (blood cancer) and have tried other standard therapies.~      This study is designed to determine whether ZIO-101 may be given safely. The study will also~     test whether ZIO-101 helps to treat blood cancer.~      We anticipate that approximately 22 to 35 patients will take part in this study.~      Arsenic has been used as a medicinal agent for centuries in many different cultures. Most~     recently in the United States, an inorganic arsenic compound was approved by the FDA for the~     treatment of patients with relapsed acute promyelocytic leukemia (APL). However, use of~     inorganic arsenic is limited by a narrow range of activity and systemic toxicity, most~     notably of the cardiac system.~      ZIO-101 is an organic arsenic derivative. In vitro testing in both the National Cancer~     Institute (NCI) cancer cell panel and in vivo testing in a leukemia animal model demonstrated~     substantial activity of SGLU against hematologic cancers. In vitro testing of SGLU using the~     NCI human cancer cell panel also detected activity against lung, colon and brain cancers,~     melanoma, and ovary and kidney cancers. Moderate activity was seen against breast and~     prostate cancers cells. Data suggest that organic arsenic generates reactive oxygen species~     in the cells to induce apoptosis and cell cycle arrest.~   "
226575|NCT00592033|"~     In COPD patients with desaturation during exercise, several studies have shown an acute~     beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and~     the American Thoracic Society guidelines recommend supplemental oxygen to patients who~     desaturate >4% and to below 88-90%. However, long-term studies have not been able to support~     this intervention. In this study of COPD patients, who desaturate and participate in a 7-week~     pulmonary rehabilitation programme, we examine the effect of supplemental oxygen on exercise~     tolerance, health status, and exacerbation rates. In a randomised design patients trained~     either with room air or with 2 litres oxygen per minute from a portable oxygen concentrator.~     All patients were asked to exercise every day for 30 minutes.~   "
226576|NCT00592020|"~     Today the minimal invasive access is used for a lot of different operations. This technique~     takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical~     complication rate (e.g. hernia, wound infection).~      Especially patients under immunosuppressive therapy could benefit from this technique. First~     results in minimally invasive kidney transplantation indicate that it may be performed~     quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical~     complications. Another retrospective study showed lower rates of hernia, abdominal wall~     relaxations, and a better postoperative cosmetic.~      The aim of this study is to compare the classic hockey stick incision with a minimal invasive~     incision in a randomized clinical trial.~   "
226577|NCT00592007|"~     The main purpose of this research study is to see if adding fulvestrant (Faslodex) to~     erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.~   "
226578|NCT00591994|"~     Tinnitus is defined as the perception of sound in the absence of a external source. About 15~     % of the population is believed to experience tinnitus and for about 20 % of them it may~     become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet~     been achieved, but modern theories focus in brain hyperactivity following inner ear damage,~     with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to~     treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological~     methods,like acoustic otoemissions and electrocochleography may reveal the changes in~     peripherical and central auditory pathways and help to choose the specific patients who could~     benefit from piribedil treatment.~   "
226579|NCT00591981|"~     Our goal is to develop a reliable, physician and patient-friendly, pre-operative Thoracic~     Onco-Geriatric Assessment (TOGA) to predict surgical risk in geriatric oncology patients with~     thoracic neoplasms of the lung, esophagus, pleura and thymus, modeled upon existing CGA~     tools, including the Preoperative Assessment of Cancer in the Elderly (PACE)~   "
226580|NCT00591968|"~     The role of teleradiology has far reaching implications for the health of remote and~     underserved populations. The ability to coordinate radiographic evaluation and diagnosis from~     a distance has the potential to raise the standard of patient care throughout the world.~     Perhaps the safest and most cost effective mode of teleradiology today is telesonography. The~     current project attempts to determine the extent that telesonography improves the standard of~     care within a rural government-run primary clinic within the Dominican Republic. The work~     reported herein is intended to compare the use of telesonography to the current standard of~     sonographic examination (referral to government hospital 60km from target clinic). The study~     was conducted by randomly assigning 100 patients with clinical indications for sonographic~     examination into experimental and control groups. Following a 60-day implementation period,~     the following research questions will be addressed: 1) To what extent does the use of~     asynchronous telesonography increase the percentage of definitive diagnoses based on the~     total number of scans (definitive diagnoses / total number of scans)? 2) To what extent does~     the use of asynchronous telesonography increase the continuity of care for patients? 3) To~     what extent does the elapsed time between scanning and final radiological interpretation~     decrease with the use of asynchronous telesonography? This study will also look at the~     history of telemedicine / telesonography and its dissemination into the mainstream practice~     of medicine, explore training protocols that may be used to assist others to establish new~     telesonography programs in a developing nations, and discuss both advances and persistent~     barriers to the implementation of telesonography programs.~      Hypothesis:~      The use of a store-and-forward telesonography system in this setting will increase the speed~     and number of final diagnoses per scan received by the target clinic and will increase the~     continuity of care by increasing the number and speed of follow-up appointments to the target~     clinic.~   "
226581|NCT00591955|"~     The purpose of this study is to determine factors which predict a complicated hospital course~     and then to develop from these findings an Emergency Department guideline to assist in~     knowing who is at highest risk of elderly patients with infection presenting for care.~   "
226582|NCT00591942|"~     The restoration of indirect partial and full coverage restorations in dentistry necessitates~     the use of a luting agent to act as a means of mechanical and potentially, chemical retention~     of the restoration. Upon the introduction of the first generation of glass Ionomer cements~     for use as a luting agent, an elevated short-term post operative hypersentivity was reported.~     In part, this adverse event was considered to be due to a desiccating effect of the cement as~     water is utilized in the setting reaction and thus a desiccation of the dentinal tubules was~     proposed as a potential mechanism leading to disruption of the neurosensory odontoblasts.~     Further materials development in the field of dental cement luting agents has lead to the~     introduction to the current market of resin formulations that have an alternative mechanism~     of setting. Consequently, there are anecdotal reports of a decrease in the incidence of~     post-operative sensitivity but no comparison with the effect of conventionally used dentin~     desensitizing agents as a part of the bonding process of the restoration.~      The purpose of this trial is a single blinded parallel design randomized clinical trial to~     evaluate the perceived incidence of post-operative sensitivity when full coverage all ceramic~     crowns or short-span three unit fixed partial dentures (dental bridge) is fabricated in the~     posterior part of the mouth. The dental crowns or bridges will be bonded with conventional~     glass ionomer cement or a Urethane dimethacrylate / Bis-GMA composite resin dental cement.~     Outcome measures will be both objective clinical criteria and the use of a calibrated pain~     survey instrument.~   "
226583|NCT00591929|"~     Decreased range of motion is common after fractures around the knee and can impact a~     patient's ability to perform activities of daily living such as rising from a seated position~     or getting in and out of a bathtub. A continuous passive motion (CPM) machine is a machine~     that continuously moves a joint (such as the knee) without the patient having to use the~     muscles in his/her leg. A goal of this therapy is to maintain as much motion as possible~     following this injury. This study is a randomized, prospective study to evaluate the~     effectiveness of CPM in maintaining knee range of motion following open reduction and~     internal fixation (ORIF) of fractures around the knee~   "
226584|NCT00591916|"~     Primary research questions/Purpose of the Research.~        1. Determine the short term (epidermal regeneration, reduction of pain, infections and~          length of stay) and long term (scarring, long term recovery, and cost of treatment)~          outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan~          and thrombin (HT).~        2. Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red~          ointment dressing.~           b. Describe the importance of the knowledge that you expect to gain from the research.~           To find a donor site dressing that has outcomes equal or better than that of scarlet~          red.~   "
226585|NCT00591903|"~     The concept of diabetic cardiomyopathy was initially defined more than 30 years ago, as~     cardiac failure in diabetic subjects in the absence of underlying coronary artery disease.~     Diabetes is also thought to contribute to earlier stage cardiac systolic dysfunction and/or~     to isolated diastolic dysfunction, in excess of underlying coronary artery disease and~     hypertension. More globally, it is recognized that subjects with type 2 diabetes have more~     extensive cardiovascular disease and a worse outcome for a similar level of disease than~     non-diabetic subjects. Despite this epidemiological evidence, the biological programming~     underpinning the myriad presentations of the diabetic heart' are poorly characterized in~     humans.~      Proteomics has emerged as an unbiased technology that enables the measurement of large~     numbers of steady-state protein levels. The potential to identify a diabetes associated~     proteomic signature in the heart would be a novel approach to identify putative biological~     programs altered by the diabetic state.~      A portion of the right atrial appendage is removed to insert the cardiac bypass machine~     cannula in certain cardiothoracic procedures. This tissue is usually discarded, however, we~     propose that it could be employed to examine whether otherwise similar subjects with and~     without diabetes have distinct atrial proteomic signatures. This pilot study may provide~     insight into potential biological pathways that orchestrate the worse cardiac prognosis in~     type 2 diabetic versus non diabetic control subjects.~   "
226586|NCT00591890|"~     Single arm, open label, Phase IB study of indibulin capsules in subjects with advanced solid~     tumors; eligible subjects will have a baseline PET scan showing a standardized uptake value~     (SUV) of ≥5.0 in ≥1 lesion on an 18F-FDG (fluorine-18-labeled deoxyglucose) scale.~   "
226610|NCT00591578|"~     The purpose of this study is to compare the efficacy and safety of TAK-491 (azilsartan~     medoxomil), once daily (QD), to valsartan in participants with essential hypertension.~   "
227147|NCT00584298|"~     This study is designed to provide information on feasibility and reproducibility of barostat~     assessments of colorectal sensory functions and compliance and their pharmacological~     modulation~   "
226587|NCT00591877|"~     Patients with refractory GERD on BID PPI's assigned to the acupuncture group will have~     significant improvement in their symptoms after receiving acupuncture for 6 weeks as compared~     to sham acupuncture given for the same duration.~      Primary Aim 1:To determine the efficacy of acupuncture in the treatment of refractory GERD.~      Participants with refractory GERD on BID PPIs randomized to yoga will have a significant~     relief in the symptoms of reflux.~      Primary Aim 2:To determine the efficacy of yoga in the treatment of refractory GERD.~   "
226588|NCT00591864|"~     The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI)~     relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal~     diagnostic mammogram and/or ultrasound study.~   "
226589|NCT00591851|"~     HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a~     protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard~     treatments for this type of cancer will help some people, but there is a moderate to high~     chance that your cancer may come back.~      The purpose of this study is to see if a new regimen will be effective in preventing cancer~     from coming back. This is a phase II trial. In this trial, patient get a drug regimen that~     has been tested in small groups of people to see what dose is safe. Researchers now wish to~     see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking~     at short-term side effects and risks of the drug. All of the drugs on this regimen can affect~     the heart which can be a serious side effect. The drugs affect on heart function is a primary~     focus.~   "
226590|NCT00591838|"~     The purpose of this study is to use SBRT in patients with early stage lung cancer and find~     out what effects (good and bad) SBRT has on their cancer. This research is being done because~     SBRT has not been used very often in patients with early stage lung cancer or in patients~     with other serious health problems. In addition, this study also will gather information~     about patient's health and hospitalization history. This information will be used to find out~     if there are any factors that can help predict recovery or outcome of patients with lung~     cancer.~   "
226591|NCT00591825|"~     The research team hopes to use brain imaging and mental testing to learn more about specific~     phobias and the treatment of phobia. When given directly prior to therapy sessions,~     D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify~     reasons why D-cycloserine has this effect by measuring brain activity.~   "
226592|NCT00591812|"~     Patients in this study require a replacement of a lower thighbone and knee joint. A new~     device, called the ComPreSs, will be used in this study to replace the lower thighbone. This~     new device has not yet been approved by the Food and Drug Administration (FDA). There is not~     enough data to assure that it is as good as other devices currently available. Taking part in~     this study will help provide data to the FDA. Other devices used to replace large pieces of~     bone and joints in the leg can result in damage to the bone over time. The bone damage can~     cause the device to come loose from the bone. This is a bad problem, and causes pain, and~     often more surgery is needed. This new device connects to the bone in a different way to~     prevent some of the problems seen with other devices. The new device protects the bone, and~     may help the replacement last longer. So far, the device has been used in over 50 patients on~     a selective basis.~   "
226593|NCT00591799|"~     The purpose of the study is to determine the safety and effectiveness of the Jarvik 2000~     Heart as a bridge to heart transplantation in end-stage heart failure patients who are~     approved heart transplant candidates.~   "
226594|NCT00591786|"~     The objective of the trial was to establish the dose-response relation of Org 25969~     (sugammadex) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during~     sevoflurane anesthesia for Japanese subjects.~   "
226595|NCT00591773|"~     The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil,~     once daily (QD), co-administered with chlorthalidone in treating individuals with essential~     hypertension, compared to treatment with chlorthalidone alone.~   "
226596|NCT00591760|"~     The aim of this study is to investigate the potential benefits of the correction of growth~     hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure~     due to left ventricular systolic dysfunction.~   "
226597|NCT00591747|"~     Women aged 50 and older are disproportionately affected by breast cancer, not only in terms~     of new diagnoses, but also in terms of survivorship. Approximately 85% of women who receive a~     first diagnosis of breast cancer are aged 50 and over, thus older women constitute the~     largest group of breast cancer survivors. Yet, few studies have focused on evaluating whether~     physical activity and exercise interventions affect long-term symptoms, physical fitness and~     function, and body composition of older breast cancer survivors. Due to the combined effects~     of breast cancer, related treatments and aging it is likely that exercise is even more~     beneficial for older breast cancer survivors than for younger survivors. Along with the~     cancer-related symptom of fatigue common to cancer survivors, older survivors face~     age-related declines in bone and muscle mass, muscle strength, bone health and physical~     function (gait and balance) that are likely exacerbated by reduced physical activity in~     survivorship and side effects of adjuvant cancer treatment. All women, regardless of age, are~     at risk for breast cancer recurrence. Recent epidemiologic evidence suggests a link between~     exercise and reduced risk of cancer recurrence in breast cancer survivors. Strength training~     is specifically suited to reverse or slow age-related declines in bone, muscle, strength and~     function and has shown promise to reduce cancer-related fatigue. However, no controlled~     trials of strength training in older breast cancer survivors have been conducted.~   "
226598|NCT00591734|"~     This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in~     the treatment of metastatic melanoma.~   "
226623|NCT00591409|"~     The objective of the trial was to establish the dose-response of T2 in Japanese and Caucasian~     Subjects. Part A: Japanese Subjects~   "
226624|NCT00591396|"~     A Phase I Trial of ZIO-101 (Darinaparsin) in Solid Tumors~   "
226625|NCT00591383|"~     Single arm, open label, Phase I, dose-escalation study of indibulin in combination with~     erlotinib in subjects with advanced histologically confirmed, solid tumors for which no~     standard therapy exists and for whom treatment with erlotinib is considered medically~     acceptable.~   "
227167|NCT00584038|"~     The purpose of this study is to determine whether contraceptive compliance by young women can~     be improved through expanded counseling by a health educator at the initial clinic visit as~     compared with standard care.~   "
226599|NCT00591721|"~     Approximately 60% of individuals with multiple sclerosis (MS) describe fatigue as their most~     disabling symptom. Energy conservation education involves teaching people with MS different~     strategies to manage fatigue and reduce its impact on daily life. Despite growing evidence of~     the effectiveness of face-to-face energy conservation education, not all people with MS are~     able to access these programs. The purpose of this project is to test the effectiveness and~     efficacy of a teleconference-delivered energy conservation education program for people with~     MS. The primary goals of the project are to reduce the impact of fatigue on participants'~     everyday lives, reduce fatigue severity, and improve quality of life. Secondary goals are to~     increase self-efficacy for managing fatigue and increase the number of energy conservation~     strategies used. The study will employ a randomly allocated two group time series design with~     a wait-list control group, which is one type of randomized control trial. A total of 181~     people with MS will be recruited through direct mailing and advertising. The program will be~     delivered by telephone teleconference by a licensed occupational therapist. Outcome measures~     will be administered over the telephone by a research assistant before and after the program,~     at three months and at six months. We hypothesize that: (1) individuals in the immediate~     intervention group achieve better outcomes than individuals in the wait-list control group;~     (2) the program leads to significant reductions in fatigue impact and fatigue severity, and~     improved quality of life; and (3) improvements in the outcomes can be maintained over six~     months.~   "
226600|NCT00591708|"~     Maximizing calcium retention by the skeleton within the genetic potential is a key strategy~     to prevent osteoporosis. It has been shown that calcium retention varies between blacks and~     whites and between gender within race. This study is designed to study the relationship~     between calcium intakes and calcium retention in Asian adolescent girls and boys. It is~     hypothesized that calcium intakes which maximize calcium retention will be lower in Asians~     than for whites studies under the same conditions. In addition it is thought that the~     differences between races in the physiological mechanisms involved in calcium metabolism will~     result in a lower calcium intake required to observe a plateau in calcium retention. This is~     turn could be translated into lower calcium requirements in Asians relative to Caucasians for~     achieving optimal peak bone mass.~   "
226601|NCT00591695|"~     The purpose of this study is to verify whether stent positioning for malignant obstruction of~     the colon and rectum followed by elective surgery allows reduction of postoperative~     complications and hospital stay without worsening of evolution of the neoplastic illness,~     compared to emergency surgery.~      Primary endpoint will be 60 days postoperative morbidity. Others endpoints will be~     postoperative mortality, length of hospital stay, need for analgesia.~   "
226602|NCT00591682|"~     Primary Objectives:~        1. To determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and~          schedule of MSX-122~        2. To characterize the dose limiting toxicities (DLTs) and determine the overall safety and~          tolerability of MSX-122~      Secondary Objectives:~        1. To determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122~        2. To evaluate the preliminary evidence for anti-tumor activity of MSX-122~        3. To perform correlative studies to elucidate signaling pathways involved in CXCR4~          activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA~          (reverse phase protein microarrays)~   "
226603|NCT00591669|"~     Inflammatory bowel disease (IBD) is a common chronic inflammatory disorder, but a noninvasive~     method of assessing disease location, severity, and extent is currently not available.~     Recently published animal data suggests that using transabdominal ultrasound enhanced with~     encapsulated gaseous microbubbles may provide a reliable, noninvasive means to detect and~     quantify areas of intestinal inflammation. This study will evaluate the role of~     Contrast-enhanced ultrasonography (CEU) for use as a diagnostic tool in patients with IBD. We~     hypothesize that the severity and extent of chronic intestinal inflammation, as quantified by~     CEU-derived video intensity scores, will correlate with endoscopically-derived measures of~     intestinal inflammation as obtained from the Crohn's Disease Endoscopic Inflammatory Index~     (CDEIS). A total of 40 patients will be enrolled in the study, 30 patients with IBD and 10~     patients undergoing colonoscopy for other reasons. Prior to colonoscopy CEU assessment of~     small and large intestine will be performed to evaluate neoangiogenesis and intestinal blood~     flow. The correlation between the CEU-derived video intensity score and CDEIS will be~     assessed using Pearson's correlation coefficient. Subjects may also undergo scoring using the~     Rutgeerts Score, an endoscopic disease assessment index used to score disease activity in~     patients with previous ileocolonic resection. Comparing video intensity between IBD and~     non-IBD subjects will be performed using the Wilcoxon rank sum test, with a secondary aim of~     establishing preliminary estimates of the sensitivity of the microbubble scoring system.~   "
226604|NCT00591656|"~     The purpose of this study is to determine the therapeutic efficacy and complications of~     systemic consolidation therapy with paclitaxel plus carboplatin following primary~     chemoradiation for locally advanced cervical cancer.~   "
226605|NCT00591643|"~     The purpose of this study is to find out if your adrenal glands are normal or abnormal. This~     can be determined by whether or not your adrenal gland concentrates more of a labeled~     building block of adrenal hormone, norcholesterol. This labeled material had been used as an~     investigative diagnostic tool for imaging adrenal glands for many years with success in our~     hands. This is a diagnostic procedure. CT, MRI and Ultrasound can determine the size and~     presence or absence of tumor but cannot assess the function of the adrenal glands. To~     determine hormone concentrations from blood samples would involve more invasive~     catherization.~   "
226606|NCT00591630|"~     The goal of this clinical research study is to learn if the addition of 90Y Zevalin to BEAM~     chemotherapy (carmustine, etoposide, cytarabine, and melphalan) and rituximab is more~     effective than the combination of BEAM and rituximab alone in patients with lymphoma who~     receive a stem cell transplant.~   "
226607|NCT00591617|"~     Building on a platform of pharmacological treatment with Suboxone (buprenorphine and~     naloxone), participants are randomly assigned to one of four psychosocial treatment~     conditions.~   "
226608|NCT00591604|"~     High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content~     after large burns.~   "
226609|NCT00591591|"~     The goal of this trial is to assess the performance of the OxiplexTS—an absolute~     near-infrared oximeter—as an instrument to measure brain oxygenation and hemodynamics in~     sleep medicine as well as in the broader field of cardiovascular/cerebrovascular diagnostics.~   "
226611|NCT00591565|"~     This study is designed to evaluate anxious patients who are only partially responsive to~     typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50%~     anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on~     Acamprosate as well. This type of add-on therapy is common in outpatient psychiatric care.~     This is a rater-blinded, patient open-label, non-placebo prospective study, where all~     subjects will receive Acamprosate for 8 weeks. This study would be the first to date in this~     treatment-resistant patient population, as the investigators will utilize the a comprehensive~     set of rating scales in order to best categorize patient responses in regards to anxiety,~     co-occurring depression, sleep disorders, alcohol use, and social functioning with this drug.~     This study may be pivotal to the initiation of future double-blind, placebo-controlled~     studies for this agent~   "
226612|NCT00591552|"~     In an effort to elucidate whether the Harmonic Scalpel will improve sealing lymphatics and~     decrease lymphatic drainage thereby decreasing the length of time that chest tubes are~     required and minimizing length of stay; the Harmonic Scalpel will be compared to a control~     group which uses electrocautery. This study will assess these two different methods to~     determine if there is a notable decrease in the amount of drainage with one versus the other.~   "
226613|NCT00591539|"~     The goal of this clinical research study is to find out if long-term survivors of childhood~     head or neck cancer, who received radiation therapy as part of the overall treatment plan,~     are at increased risk of thickening or blockage of the carotid arteries (the major blood~     vessels in the neck).~      Researchers also want to find out if other medical conditions, such as high blood sugar, high~     blood cholesterol, or history of tobacco use may contribute to the thickening or blockage of~     the carotid arteries.~   "
226614|NCT00591526|"~     The first purpose of this randomized trial will be to compare the best treatment group of APL~     93 trial (ATRA with early introduction of anthracycline-AraC chemotherapy, followed by 2~     consolidation anthracycline-AraC courses and maintenance combining continuous chemotherapy~     and intermittent ATRA) to the same regimen, but without AraC. It is hoped that the~     investigational arm, with anthracycline alone chemotherapy (without AraC), will have reduced~     toxicity without increasing the incidence of relapse, by comparison with a classical~     induction/consolidation anthracycline-AraC regimen~      Thus :~      the main end point for this first randomization is relapse at 2 years secondary end points~     are : complete remission rate ; survival and event free survival at 2 years, and~     quality-adjusted survival (Q-TWiST).~      2) Because patients with initial WBC counts > 10000/mm3 (ie very high counts for APL) appear~     to remain at relatively high risk of relapse even with the current reference treatment, they~     will not be included in this trial that assesses the reduction of chemotherapy. On the~     contrary: i) they will all receive the standard chemotherapy (best treatment group of APL 93~     trial);~      Thus :~      the main end point for this second randomization is relapse at 2 years secondary end points~     are : survival and event free survival at 2 years 3)Elderly patients with initial WBC ≤~     10000/m3 will receive consolidation chemotherapy without AraC during the first chemotherapy~     course, and reduced doses of AraC during the second and third course, followed by G-CSF.~   "
226615|NCT00591513|"~     This clinical trial tests the hypothesis that engineered human skin can reduce the~     requirements for harvesting of conventional skin autografts by providing more skin for~     grafting from the donor skin used to treat the wounds. In life-threatening burns (e.g.,~     greater than 50% of the total body surface area), greater availability of skin may be~     definitive to patient survival, and may reduce scar formation at the donor site, and from use~     of widely-meshed skin autograft.~   "
226616|NCT00591500|"~     The goal of this study is to find out if some people are more likely to get melanoma, a form~     of skin cancer, than others are. To do this we will compare people who have had more than one~     melanoma to people who have had only one melanoma and to people who are similar but who have~     not developed melanoma.~      People respond to the environment in different ways. Some may be born with genes that make~     them more likely to get this type of skin cancer. Each person has many ways to repair normal~     damage to their genes. Specific genes may affect the repair of sun damage. Other genes affect~     the way the skin itself reacts to the sun. We want to find out which genes have normal~     changes in them and lead to different responses to exposures, such as the sun. We also want~     to find out if sun habits are related to the way these genes work.~   "
226617|NCT00591487|"~     RCT of S/E of lidocaine infiltration in tumescent technique.~   "
226618|NCT00591474|"~     Drinking probiotics in a the form of a yogurt drink will restore normal gastrointestinal (GI)~     bacteria in patients whose colon are colonized with vancomycin-resistant enterococcus (VRE).~   "
226619|NCT00591461|"~     Barrett's esophagus (BE) is a condition that often occurs in patients who have had GERD for a~     long time. The researchers are interested in BE because it can sometimes become a cancer in~     the esophagus. The way that we currently diagnose BE is by performing an upper endoscopy and~     looking for a change in the color of the esophagus. This color change may represent BE. If~     the doctor sees this, he/she may take biopsies of this area.~      Studies have shown that making the diagnosis of BE can be hard to make. One of the reasons~     why this may be is because doctors may interpret what they see differently during the~     procedure. In other words, they may see an esophagus that appears normal in color or abnormal~     in color.~      The purpose of this study is to compare two doctors' impressions of the appearance of the~     esophagus during a single endoscopy procedure.~   "
226620|NCT00591448|"~     The purpose of this study is to evaluate the use of Virtual Reality (VR) technology during~     Physical Therapy (PT) and/or Occupational Therapy (OT) for patients with burns. Research~     questions: Do patients have increased joint Range of Motion (ROM) and reduced pain when using~     VR during PT compared to PT/OT when VR is not used? Do scores on an imaging ability scale~     correlate with the effects of VR when used with PT/OT? Do adults and children differ in their~     ability to engage in the virtual world?~   "
226621|NCT00591435|"~     Anaesthesia and surgery related time intervals of three standard operations are compared~     depending on whether residents or consultants are performing anaesthesia and surgery.~      Hypothesis: Perioperative workflow is influenced by state of education, time intervals~     reflecting anaesthesia as well as surgical performance increase due to resident training.~     Therefore, costs of perioperative care increase as well.~   "
226622|NCT00591422|"~     The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas~   "
226626|NCT00591370|"~     Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to~     DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by~     mouth, it can be given daily over a long period of time. We think that temozolomidemay work~     best if it is given every day for 6 weeks at a time. Temozolomide given by this extended~     schedule is experimental, although we have found that it is safe and can shrink melanoma in~     some patients.~      One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it~     can be given daily over a long period of time rather than off and on like DTIC. We think that~     TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule~     is experimental although we have found that TMZ given in this way is safe and can shrink~     melanoma in some patients. When extended dosing TMZ was given with either thalidomide or~     long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this~     shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in~     melanoma by themselves.~      In this study, we will treat patients with TMZ alone using this extended dosing schedule to~     see how many patients experience tumor shrinkage.~      We also want to learn more about which tumors are more likely to shrink from TMZ treatment.~     We will test samples of your tumor for whether or not a gene called MGMT has been turned on,~   "
226627|NCT00591357|"~     To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and~     mortality of this serious nosocomial infection in patients who have antibiotic-associated~     diarrhea. Both C. diff positive and negative patients will be included.~   "
226628|NCT00591344|"~     The goal of this trial is to compare the effect of two different exercise programs on~     neuro-physiological, motor, functional, and quality-of-life issues in individuals with~     Parkinson's disease to determine which program is most beneficial.~   "
226629|NCT00591331|"~     This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in~     humans, after exposure to UV radiation.~   "
226630|NCT00591318|"~     Many patients with schizophrenia and schizoaffective disorder have symptoms that persist,~     including hallucinations or delusions, despite adequate pharmacotherapy with antipsychotic~     drug. Glutamate is a major excitatory neurotransmitter in the brain that has been implicated~     in several brain diseases. NMDA antagonist drugs cause symptoms of psychosis in otherwise~     normal persons. It is postulated that reduced NMDA receptor mediated neurotransmission leads~     to an increase in synaptic glutamate. Excessive synaptic concentrations of glutamate can~     produce excitatory neurotoxicity. Agents which reduce excess glutamate activity are~     neuroprotective. This therapeutic strategy has been applied to schizophrenia through the use~     of compounds that reduce presynaptic release of glutamate or otherwise decrease excessive~     postsynaptic stimulation, including lamotrigine, memantine and a m-GLU-R2 agonist (LY354740)~     with the hypothesized result of a reduction in psychotic symptoms.~      Recently it was shown that a commonly available antibiotic (ceftriaxone) has the unique~     neuroprotective function of decreasing the amount of extracellular glutamate in nervous~     system tissue by increasing the number of glutamate transporter proteins. Our clinical~     experience with patients who have refractory psychosis and past Lyme disease indicates that~     in some patients psychosis may improve with IV ceftriaxone therapy. Whether this improvement~     was due to its antimicrobial or glutamate effect or a placebo effect is uncertain. In a~     placebo-controlled design, this study investigates the ability of ceftriaxone to decrease~     psychotic symptoms in patients with refractory psychotic disorders. In addition, the study~     will examine glutamatergic functional activity before and after treatment using brain imaging~     with magnetic resonance spectroscopy.~   "
226631|NCT00591305|"~     This study will determine efficacy of a new and combined treatment of laryngeal recurrent~     respiratory papillomatosis (RRP), by using a 585 nm pulsed dye laser (PDL) and a dietary~     supplement, diindolylmethane (DIM). We will compare this new treatment with PDL-only, in a~     total of 30 children (15 of each treatment), to determine whether this combined treatment~     would be effective and safe in preventing the RRP recurrence. This is the first study to~     combine PDL technique with DIM, to develop a new, voice-preserving and long-term effective~     method of managing laryngeal RRP in children.~   "
226632|NCT00591292|"~     Dose escalating study of orally administered indibulin at twice daily schedule in subjects~     with solid tumors.~   "
226633|NCT00591279|"~     This study evaluates strategies for the surveillance of post-polypectomy patients for the~     control of bladder cancer~   "
226634|NCT00591266|"~     The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil,~     once daily (QD), co-administered with amlodipine in treating individuals with essential~     hypertension, compared to treatment with amlodipine alone.~   "
226635|NCT00591253|"~     The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil~     compared to placebo, once daily (QD), in African-American participants with essential~     hypertension.~   "
226636|NCT00591240|"~     The purpose of this proposal is clinical validation of an electrochemical biochip for rapid~     pathogen identification and antibiotic susceptibility determination.~   "
226637|NCT00591227|"~     This study will examine two questions: 1. Whether insulin treatment of high blood sugar in~     patients with diabetes while they are in the emergency room will improve how quickly they~     recover from illness if they need to be hospitalized. 2. Whether immediately beginning long~     lasting insulin detemir in patients with diabetes when they are admitted to hospital from the~     emergency room will improve how quickly they recover from the illness which necessitated~     hospitalization.~   "
226638|NCT00591214|"~     The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C~     virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with~     chronic hepatitis C.~   "
226639|NCT00591201|"~     Tumor necrosis factor (TNF) alpha is a pro-inflammatory cytokine playing a significant role~     in the pathogenesis of the spondyloarthropathies (SpA). Infliximab is a TNF alpha blocking~     monoclonal antibody efficacious and safe as treatment of adult-onset SpA.~      In this study we will try to demonstrate that infliximab administered at 5mg/kg to patients~     with juvenile onset SpA over a period of 12 weeks will have more efficacy than placebo and~     that it will be well tolerated. At the end of this phase, patients will go into a 52-week~     open extension to demonstrate sustained efficacy, safety, and tolerability of infliximab We~     will include 34 patients with juvenile onset SpA unresponsive to standard treatment. Efficacy~     will be assessed by counting the number of actively inflamed joints and a number of other~     parameters.~   "
226645|NCT00591123|"~     In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen~     known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study~     is to test the safety and effectiveness of this combination of chemotherapy drugs and to see~     how they affect your cancer.~      Another purpose of this study is to examine samples from your blood and tumor. This research~     will be done to better understand how subjects respond to treatment. Specifically,~     researchers will look at the way your genes and proteins respond to drugs like those used in~     this study.~   "
226646|NCT00591110|"~     The study design is a randomized intervention evaluation. Ten senior centers in predominately~     African American communities in the Birmingham, Alabama will be selected as sites for the~     educational intervention. Five centers will be randomly assigned to receive an educational~     intervention communicating practical information about vision, eye conditions and eye care as~     pertinent to the older African American population. The other five centers will serve as~     social-contact controls, where participants will receive an engaging information session on a~     non-health related topic. The primary outcome of interest is the change in percentage of~     persons receiving comprehensive eye care from pre- to post- intervention. The secondary~     outcomes are the process outcomes of improvement in knowledge, attitudes, and values about~     vision, eye conditions, and eye care.~   "
226647|NCT00591097|"~     The reported normal values used in diagnosing and treating pediatric kidney stone formers are~     based on adult values or historic data from small studies. Urinary supersaturation indices~     which are now described in the adult stone literature as more sensitive predictors of stone~     composition, and precise predictors of response to therapy, are not established in children.~     The goals of this prospective study are to redefine normal values for pediatric urinary~     metabolites and supersaturation indices based on samples from a large number of healthy~     children and to identify if a difference in urinary supersaturations in children is~     protective.~   "
226648|NCT00591084|"~     The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute~     ischemic stroke.~   "
226649|NCT00591071|"~     During hospitalization in the intensive care unit (ICU), the occurrence of a blood glucose~     imbalance is frequent and associated with increased mortality. These observations have~     resulted in the hypothesis that intensive insulin therapy designed to control blood glucose~     would improve the prognosis of patients admitted into the ICU. In a prospective, randomized,~     single center study in a surgical ICU during which the majority of patients had undergone~     cardiac surgery, intensive insulin therapy with the objective to maintain glycemia below 110~     mg/dl (6.1 mmol/L) provided a significant reduction in ICU mortality and hospital mortality~     compared to a group with a glycemic objective of 200 mg/dl.~      In a recent published article, the beneficial effect of intensive insulin therapy seems less~     obvious in a randomized single center study in a medical ICU. One of the potential factors~     limiting the impact of a therapeutic strategy like this one is the absence of achieving~     strict glycemic control for all patients on intensive insulin therapy. Additionally, the~     implementation of such a therapeutic strategy results in an increased risk of hypoglycemia,~     the consequences of which on morbidity remain unclear.~      The aim of our study is to determine, in a mixed population of medical and surgical patients~     admitted to the ICU, requiring artificial ventilation with a expected duration above 48~     hours, the impact of effective strict glycemic control (<6,1 mmol/l) compared to a~     conventional glycemic control (<11mmol/l) on hospital mortality.~   "
226650|NCT00591058|"~     The purpose of this study is to evaluate the safety and biologically active dose of TM-601 in~     adult patients with recurrent malignant glioma.~   "
226651|NCT00591045|"~     This is a randomized phase II multicenter controlled study of oxaliplatin, calcium folinate,~     and 5-fluorouracil (mFOLFOX7) as neoadjuvant chemotherapy for resectable advanced gastric~     cancer.~      Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the~     control.~   "
226652|NCT00591032|"~     AQUA FONTIS is a unicentric, multidisciplinary, prospective cross-section and longitudinal~     study that aims at the development of a more clear-cut diagnostic definition and~     classification of non-thyroidal illness syndrome (NTIS).~   "
226653|NCT00591019|"~     A study on the effects of the FDA approved drug Modafinil upon attention problems associated~     with tinnitus. This is considered to be a safe drug with few side effects. Each subject will~     be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive~     testing and recordings will be taken. The study involves each subject taking a 2- week supply~     of Modafinil and a 2- week supply of placebo. We hypothesize inattention related to~     thalamocortical dysrhythmia found in tinnitus can be reduced by Modafinil thus improving~     vigilance.~   "
226654|NCT00591006|"~     The purpose of this research is to determine if patients who receive phenytoin (also commonly~     known as Dilantin) before taking corticosteroids will show less memory impairment and~     hypomanic symptoms (feelings of agitation, overexcitement or hyperactivity) than those~     receiving placebo (an inactive substance). This research also seeks to determine if patients~     taking phenytoin before corticosteroids show more activity in the area of the brain involved~     with memory than those receiving placebo.~      This research is being done because increased levels of cortisol (the body's natural~     corticosteroid) in the body are frequently associated with forgetfulness, and interventions~     that may prevent or reverse this effect are of great importance.~   "
226655|NCT00590993|"~     Past studies have shown that MRI is useful for staging prostate cancer. This study will use~     magnetic resonance spectroscopic imaging (MRSI) to obtain more information. MRSIs with MRIs~     help doctors locate prostate cancer and determine the extent of tumor before deciding on~     treatment. This study looks at structural and chemical properties of prostates in prostate~     cancer patients before and after treatment.~   "
226656|NCT00590980|"~     Patients with blockage of the blood vessels that supply blood to the back of the brain, known~     as vertebrobasilar disease (VBD), are at risk of having a stroke or temporary symptoms of a~     stroke known as transient ischemic attack (TIA). The risk of repeated stroke associated with~     VBD may be affected by several risk factors, including the degree to which the blockage~     reduces the blood flow to the brain. Patients with VBD have different levels of blockage~     ranging from partial blockage to complete blockage, which can affect the blood flow to the~     brain by variable amounts. The purpose of this research is to determine if patients with~     symptomatic VBD who demonstrate low blood flow to the back of the brain on magnetic resonance~     (MR)imaging are at higher risk of developing another stroke or TIA than patients with normal~     blood flow.~   "
226657|NCT00590967|"~     Recent studies have shown that the chance of survival among women with advanced cervical~     cancer is increased when they receive concurrent chemotherapy and radiation to the pelvis.~     However, patients who have advanced disease show loco-regional failure as well as a high~     incidence of distant metastasis. Positron emission tomography (PET) scanning has high~     sensitivity and specificity in the detection of pelvic and para-aortic lymph node metastases.~     While the detection of para-aortic metastases by PET significantly impacts prognosis, PET has~     been known to show positive lymph node metastasis in the pelvis only while not detecting~     micrometastatic disease in the para-aortic lymph nodes (despite the fact that they are~     histologically known).~      In addition, patients with positive para-aortic lymph nodes on PET, greater amounts (more~     than 45 Gy) of radiation must be used to improve the probability of controlling the cancer.~     However, doses greater than this have been limited because of the dose and volume limits to~     the small bowel. But, Intensity Modulated Radiation Therapy (IMRT) is a new way of~     calculating and delivering radiation therapy. Compared to external beam radiation, IMRT has~     the improved ability to deliver large doses of radiation to specific targets while minimizing~     the exposure to surrounding normal tissue.~      With IMRT, however, the effective dose/volume can be increased more safely and lower the~     toxicity of surrounding tissue, thus making prophylactic dosing to para-aortic lymph nodes~     not detected by PET safer and more effective.~   "
226658|NCT00590954|"~     The purpose of this study is to test the effectiveness of perifosine in preventing further~     tumor growth using the established optimal dose of the drug. A second goal is to determine if~     perifosine can block the molecules in the tumor that drive it to divide and grow.~   "
226659|NCT00590941|"~     The purpose of this study is to determine whether people have genes that make them more~     likely to respond to chemotherapy and/or have side effects from chemotherapy for diffuse~     large cell lymphoma.~   "
226660|NCT00590928|"~     H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill~     patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor~     antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is~     unknown, whether proton pump inhibitors are more effective in increasing gastric pH than~     H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.~   "
226661|NCT00590915|"~     The purpose of this study is to make Erwinase available to patients with acute lymphoblastic~     leukemia (ALL) who have had previous allergic reactions to certain formulations of~     L-asparaginase.~   "
226662|NCT00590902|"~     The purpose of this study is:~        -  To measure the ability of OSI-774 to effectively treat bronchioloalveolar cell lung~          cancer.~        -  To see whether the use of OSI-774 provides meaningful symptomatic benefit in patients~          with advanced bronchioloalveolar cell lung cancer.~      This study is a Phase II study. The first study of OSI-774 was done to evaluate what dose~     should be given to patients with cancer has been completed. The purpose of this research~     study is to see whether this experimental treatment, called OSI-774, can cause a type of~     non-small cell lung cancer to stop growing or shrink. This study is sponsored by a company~     called Genentech, and is being done at Memorial Hospital, as well as other cancer centers~     around the country interested in developing new drugs for the treatment of this type of~     cancer.~   "
226663|NCT00590889|"~     The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces~     the incidence of prosthetic valve endocarditis (PVE).~   "
226664|NCT00590876|"~     In patients with Type 1 Diabetes Mellitus, hypoglycemia (low blood sugar) is the~     rate-limiting step to achieve glucose level control. As a result, understanding the body's~     responses (including the brain's response) to hypoglycemia is essential for the effective~     treatment of patients with T1DM. The purpose of this research is to determine whether~     pancreatic islet cell allotransplantation to restore normoglycemia (normal blood glucose~     levels) in Type 1 Diabetic patients with hypoglycemia unawareness alters brain fuel~     utilization and cognitive performance under euglycemic (blood sugar at 100 mg/dl) and~     hypoglycemic (blood sugar at 50 mg/dl) conditions. Three groups of subjects will be studied:~     (1) T1DM patients with a history of severe hypoglycemia and/or hypoglycemia unawareness who~     have been selected for pancreatic islet cell allotransplantation; (2) T1DM patients who also~     have a history of severe hypoglycemia and/or hypoglycemia unawareness; (3) nondiabetic~     subjects. All subjects will undergo identical testing including: (a) screening; (b)~     neuropsychological testing; (c) and functional magnetic resonance imaging (fMRI) during~     euglycemic and hypoglycemic conditions.~   "
226665|NCT00590863|"~     This study will compare whether a combination of antidepressant medications is better than~     one antidepressant medication alone when given as initial treatment for people with chronic~     or recurrent major depressive disorder.~   "
226666|NCT00590850|"~     Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder.~     Some surgeons suggest that surgical treatment is the best option, while others suggest that~     nonoperative care is the best treatment. There is no evidence to date that either option in~     superior. For this reason, we propose to conduct a prospective, randomized clinical trial of~     surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This~     study will use both objective clinical and patient-based outcome measures. The purpose of~     this study is to see if there is a difference between clinical outcomes (healing rate, time~     to healing, time to return to work, Constant Score, complications), functional outcomes (DASH~     Score), and health related quality of life (SF-36) in nonoperative care and two types of~     surgical care for displaced fractures of the clavicular shaft in adults.~      Included patients will be randomized into one of three groups: nonoperative care (Group N);~     surgical care using plates and screws (Group P); and surgical care using intramedullary pin~     put inside of the clavicle to stabilize it (Group I).~   "
226667|NCT00590837|"~     A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5~     + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in~     complete remission (CR) will then receive a post-remission schedule with or without lomustine~     according to randomization. Patients from 60 to 65 years old will be proposed to reduced~     conditioning allogeneic transplantation after first consolidation.~   "
226668|NCT00590824|"~     Evaluate the antitumor activity of hu14.18-IL2 in the minimal residual disease setting.~     Evaluate the time to recurrence and overall survival of patients treated with hu14.18-IL2.~   "
226671|NCT00590785|"~     To compare disease-free survival (DFS), overall survival (s), and toxicity of high-isk~     primary breast cancer patients with negative axillary lymph nodes or with one to three~     positive nodes treated with adjuvant high-dose chemotherapy with doxorubicin plus~     cyclophosphamide (AC), versus high-dose sequential chemotherapy with doxorubicin followed by~     cyclophosphamide (A-->C).~   "
226672|NCT00590772|"~     The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease~     nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep~     fragmentation in individuals with year round allergic rhinitis or perennial allergic rhinitis~     (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.~   "
226673|NCT00590759|"~     The purpose of this post-approval study is to evaluate the long-term performance of the GORE~     TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic~     aortic (DTA) aneurysms~   "
226674|NCT00590746|"~     The purpose of this study is to assess the risk for falls among elderly Emergency Department~     (ED) patients.This study will use 2 tests of balance, the Bertec Balance Screening Test and~     the Up and Go test. These tests measure how steady a person is while standing, walking, and~     turning 180 degrees. After patients have returned home, they will be contacted at 7 days, 30~     days and 6 months to determine if they have sustained a fall during these intervals in order~     to find out how predictive the balance tests are in determining the risk of future falls.~   "
226675|NCT00590720|"~     The main objective of this study is to evaluate the safety and tolerability of multiple fixed~     doses of MEDI-528 in adult patients with stable asthma and exercise-induced~     bronchoconstriction (EIB).~   "
226676|NCT00590707|"~     This research is being done to see what effects sedative drugs during surgery have on~     peoples' thinking processes after they wake up.~   "
226677|NCT00590694|"~     Patients with neovascular Age-related macular degeneration (AMD) and the particular feature~     of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for~     ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such~     patients but only treated with ranibizumab until fluid within the layers of the retina was~     absent, not until the entire PED was absent. This study hypothesizes that there may be a~     difference in benefit between patients treated until just the retinal edema is gone and those~     in which the retinal edema and PED are both gone.~   "
226678|NCT00590681|"~     This study is being conducted to help determine whether the addition of Avastin (an~     anti-cancer drug), when given along with temozolomide during the monthly cycles that follow~     radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM~     live. This study is sponsored by Genentech, Inc., the manufacturer of Avastin.~      Avastin is the experimental drug being administered in this research study. Avastin binds a~     protein called vascular endothelial growth factor, or VEGF. VEGF is produced by tumors and~     circulates in the blood. One of VEGF's main roles is to support the growth of new blood~     vessels. During cancer, VEGF promotes the growth of blood vessels that bring nutrients to~     tumor cells and help them grow. Avastin binds to VEGF, which then prevents VEGF from~     functioning. In laboratory studies, Avastin prevented the growth of several different types~     of cancer cells grown in animals. Avastin was approved by the Food and Drug Administration~     (FDA) for the treatment of metastatic colorectal cancer in combination with chemotherapy.~     Avastin has not been approved by the FDA for the treatment of GBM and is, therefore,~     considered experimental. Avastin is currently undergoing testing (alone and in combination~     with another anti-cancer drug, irinotecan) in persons with GBM that have come back after~     conventional treatment.~      Temozolomide (Temodar) is an anti-cancer drug that works by interfering with the growth of~     cells (including cancer cells) by stopping their division. Temozolomide was approved by the~     U.S. FDA for the treatment of newly diagnosed GBM in 2005.~      Avastin and temozolomide are currently being used together in several research studies~     involving people with newly diagnosed GBM. Limited information is available about either the~     safety or effectiveness of this drug combination.~   "
226679|NCT00590668|"~     Subjects eligible for this study have an irregular heartbeat called atrial fibrillation~     (AF)and who are scheduled for a procedure that involves applying electrical energy in your~     pulmonary veins, which is usually the site where this abnormal rhythm begins, or pulmonary~     vein ablation~      We will examine the size and function of the left atrium (one of the 4 chambers of your~     heart) and the pulmonary veins before and after your ablation. This will be done by getting~     extra measurements during tests you will be having done which are ICE (intra cardiac~     echocardiography), TEE (transesophageal echocardiography) and CT scan (computed tomography),~     and drawing some blood samples.~      The purpose of getting these extra measurements and blood samples is:~        1. to see whether TEE measurements done before your ablation can tell us if your atrial~          fibrillation may come back after you ablation;~        2. to see if TEE measurements look different before and after your ablation;~        3. to see if a blood test can tell us if your atrial fibrillation may come back after your~          ablation;~        4. to look at how often pulmonary vein narrowing is found by TEE compared to how often it~          is found by CT scan.~      During the clinically indicated tests the doctor has ordered (TEE, ICE, CT scan), there will~     be additional measurements taken as a part of this research. This means that the TEE exam~     will last an additional 10-15 minutes, and the ICE procedure will last an additional 5-10~     minutes. There is no additional time needed for the CT scan. In addition, we will be drawing~     20 cc of blood (approximately four teaspoons).~      The regularly scheduled follow up visit is usually three months after your ablation, we will~     again be getting some extra measurements from the TEE and CT scan. This will add about 10-15~     minutes to the TEE test, but no additional time will be needed for the CT scan. In addition,~     we will be drawing 10 cc of blood drawn (approximately two teaspoons). A~     ventilation-perfusion scan of the lungs will also be performed as part of standard clinical~     care if significant PV stenosis is found by CT and/or TEE.~   "
226680|NCT00590655|"~     The aim of this study is to compare a weight reduction programme with and without a~     maintenance programme in patients with severe obesity.~   "
226681|NCT00590642|"~     This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive~     Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large~     percentage of patients fail to respond to medications and have residual symptoms. Such~     patients are referred to as having treatment resistant OCD.~   "
226682|NCT00590629|"~     Several risk factors including high cholesterol contribute to heart disease. We know that~     lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for~     heart disease. We expect that women will share this same benefit because the combination of~     high triglycerides and low HDL appears to be a more important risk for heart disease in~     women. Niacin reduces triglycerides and raises HDL. We also expect to see improvement in~     markers of inflammation and clot formation and blood vessel health, which we hypothesize~     should all confer a reduced risk of heart disease in women.~      Women already taking lipid lowering statin will receive niacin therapy. We will measure blood~     lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood~     vessel reactivity. After 3 months of therapy we will repeat these measures.~   "
226683|NCT00590616|"~     Aortic atheroma has been correlated with traditional cardiac risk factors, coronary, carotid,~     renal and peripheral atherosclerosis, and is probably a manifestation of generalized~     atherosclerosis. Aortic atheroma has also been shown to be associated with atrial~     fibrillation, aortic valve sclerosis, and other calcification of the fibrous skeleton of the~     heart. None of the previous studies have looked at the noninvasive prediction of aortic~     atheroma using the history and physical signs of cardiovascular disease. This would be a time~     and cost-effective bedside diagnostic tool that would be useful prior to cardiac surgery,~     cardiac catheterization, and workup of ischemic stroke patients, especially when~     transesophageal echocardiogram (TEE) is being considered for diagnosis but cannot be obtained~     due to previously mentioned reasons. Although physical examination of peripheral vascular~     disease is non-specific, a combination of physical examination signs increases the~     probability of generalized atherosclerosis.~   "
226684|NCT00590603|"~     This is a phase I dose escalation study to estimate the maximum tolerated dose (MTD) of the~     novel combination of Arsenic, Ascorbic Acid and Velcade, followed by a phase II study~     conducted using the MTD estimated from the phase I portion.~   "
226685|NCT00590590|"~     This study will evaluate the efficacy and safety of two vaginal products compared with that~     of placebo to determine if the two products are better than placebo in the relief of vaginal~     discomfort.~   "
226686|NCT00590577|"~     The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses~     of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. in~     the deltoid muscle followed by either deltoid or gluteal injections for a total of 13 weeks~     of treatment as compared with placebo in patients with schizophrenia.~   "
226687|NCT00590564|"~     Researchers want to see whether Sho-saiko-to (SST) can help in patients with chronic~     hepatitis C. Chronic hepatitis C may cause swelling within the liver and this can lead to~     scar tissue. In some patients, severe scarring of the liver, liver failure and liver cancer~     can occur. Standard treatment for chronic hepatitis C is a drug called interferon with or~     without another drug called ribavirin. There are a number of side effects that some patients~     are unable to take. Other patients may have an initial response, but then the virus and the~     inflammation come back.~      Sho-saiko-to is an herbal medicine that has been used for many years in Asia to treat liver~     disease. The purpose of the study is to evaluate whether Sho-saiko-to may improve liver~     swelling and injury caused by chronic hepatitis C.~   "
226688|NCT00590551|"~     There are many reasons that cause skin to breakdown. This study will only compare~        -  pressure~        -  pH~        -  temperature~      with the use of slings and without the use of slings (fabricated device used to safely handle~     patient transfers and repositioning).~      There will be no difference in skin pressure, pH, or temperature with or without the use of~     slings.~   "
226689|NCT00590538|"~     The purpose of this research study is to test a new combination of medicines, Phenylbutyrate~     and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most~     common genetic mutation found in patients with CF is called Delta F508. Due to this mutation,~     there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines,~     pancreas and sweat glands. This lack of movement causes the clinical manifestations of the~     disease.~      Although Phenylbutyrate has been extensively used to treat patients with rare metabolic~     diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein~     is a naturally occurring substance that is found in food products such as soy and tofu, but~     is also an investigational drug for this study. When used together, both drugs may be able to~     restore normal chloride and salt (water) movements in body organs and glands in people with~     CF.~      We will be studying salt and water movement in the nose by a technique called nasal~     transepithelial potential difference (NPD).~   "
226690|NCT00590525|"~     The laboratory test, C-Reactive Protein (CRP), has become well established as a marker of~     inflammation. Recently a high CRP level (indicating an increase in inflammation) was~     identified as a risk factor for atrial fibrillation. We are conducting this study with~     patients such as yourself with atrial fibrillation who are planning to undergo cardioversion~     to determine what sort of relationship exists between CRP levels and atrial fibrillation. We~     will then look at success rates of converting atrial fibrillation to normal sinus rhythm,~     compared to patients' CRP levels.~   "
226691|NCT00590512|"~     The purpose of this study is to look at the effects of high- and low-salt diets on blood~     vessel function in healthy subjects.~   "
226692|NCT00590499|"~     Agitation is a significant clinical issue in anesthesiology and critical care medicine.~     Several studies have carried out to survey the epidemics of agitation in post-anesthesia care~     unit and intensive care unit, and results revealed that agitation had an adverse impact on~     outcomes. To our clinical experience, agitation can occur in postoperative neurosurgical~     patients, and is often difficult to manage. However, agitation in this subset of patients is~     poorly evaluated. In present study, adult patients following craniotomy will be enrolled~     consecutively, and incidence, risk factor and outcome of emergent agitation will be~     investigated. The results of the study will provide basic data for prevention and treatment~     of agitation in postoperative neurosurgical patients.~   "
226693|NCT00590473|"~     The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms~     of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation~     as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices.~      This study will be a prospective randomized study comparing bilateral to unilateral sacral~     neuromodulation. The study population will include all patients diagnosed with interstitial~     cystitis, using the NIDDK criteria, having staged sacral neuromodulator stimulators placed at~     Hahnemann University Hospital.~   "
226738|NCT00589862|"~     It is recommended that patients who have drug-eluting stents placed in their coronary~     arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking~     these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs~     are at a higher risk of clots occurring inside the stents which may result in a heart attack.~     At the present time, it is unknown if increasing the doses of the antiplatelet agents is~     effective in overcoming this resistance. The purpose of this project is to identify patients~     with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel)~     dose overcomes antiplatelet drug resistance.~   "
226694|NCT00590460|"~     The purpose of this study is to discover whether children and adults with Fanconi anemia (FA)~     can be safely and effectively transplanted with Human Leukocyte Antigen (HLA) mismatched (up~     to one haplotype), HLA-matched sibling, or unrelated donor stem cells, when leukocytolytic~     monoclonal antibodies are the sole conditioning agents (patients receiving an HLA mismatched~     transplant will receive Fludarabine as part of the conditioning regimen). Three monoclonal~     antibodies (MAb) will be used in combination. Two of them, YTH 24 and YTH 54 are rat~     antibodies directed against two contiguous epitopes on the CD45 (common leucocyte) antigen.~     They have been safely administered as part of the conditioning regimen for 12 patients~     receiving allografts (HLA matched and mismatched) at this center. They produce a transient~     depletion of >90% circulating leucocytes. The third MAb is Campath 1H, a humanized rat~     anti-CD52 MAb. This MAb has been widely used to treat B cell chronic lymphocytic leukemia~     (B-CLL) and more recently has been safely given at this and other centers as part of a~     sub-ablative conditioning regimen to patients with malignant disease. Because these MAb~     produce both profound immunosuppression and significant, though transient, myelodestruction~     we believe they may be useful as the sole conditioning regimen in patients with Fanconi~     anemia, in whom the use of conventional chemotherapeutic agents for conditioning produces a~     high rate of short and long term toxicity. We anticipate MAb mediated subablative~     conditioning will permit engraftment in a high percentage of these patients with little or no~     immediate or long term toxicity. Campath IH persists in vivo for several days after~     administration and so will be present over the transplant period to deplete donor T cells as~     partial graft versus host disease (GvHD) prophylaxis. Additional GvHD prophylaxis will be~     provided by administration of the medication FK506.~   "
226695|NCT00590447|"~     This phase-II trial will investigate the efficacy, safety and the tolerability of a~     sequential therapy consisting of 4 courses of single agent rituximab followed by 4 courses of~     R-CHOP chemotherapy in patients with CD20+ posttransplant lymphoproliferative disorders~     (PTLD). However, responders to rituximab achieving a CR after the first 4 applications of~     rituximab will go on with rituximab monotherapy and will not receive chemotherapy.~   "
226696|NCT00590434|"~     The aim of the study is to study the risk of colorectal cancer and polyps in people older~     than 80 years compared to the younger age group. The researchers hypothesized that~     colonoscopy in older people is likely to have more complications without detection of a~     significant number of large polyps and cancer.~   "
226697|NCT00590421|"~     Background: During the first half of the 20th century, scalp irradiation was a standard~     treatment for induction of epilation in children suffering from Tinea Capitis. These children~     are now more than 50 years old and the aim was to investigate the possible association~     between their childhood low dose irradiation exposure and development of carotid~     atherosclerotic disease in adulthood.~      Methods: The study included 145 individuals treated by irradiation in their childhood, and~     150 matched control subjects with no history of irradiation. B-mode ultrasound imaging and US~     Doppler were used to measure carotid and femoral stenosis and Intima-Media Thickness (IMT).~     Blood samples were taken for lipid profile and homocysteine evaluation.~   "
226698|NCT00590408|"~     Statins are medications that lower blood cholesterol by inhibiting cholesterol production in~     the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report~     muscle aches/pain while taking statins. In a very small percentage of patients (<0.01%; less~     than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle~     damage. In these patients, statins must be discontinued. In some reports, patients taking~     statins have reduced blood levels of coenzyme Q10. Coenzyme Q10 is an essential protein which~     is present in all human cells needed for normal cell function. Coenzyme Q10 has been tested~     in patients with heart failure where it has been shown to be safe and effective. Many~     patients with heart conditions take coenzyme Q10, but the risks and benefits of~     supplementation with this product is unknown. Coenzyme Q10 is considered a dietary supplement~     and is not approved by the Food and Drug Administration (FDA) for any medical condition.~     Coenzyme Q10 has very few, if any, side effects. Upset stomach (gastritis), headache, body~     ache, and low blood pressure have been reported. The objectives of this project are to test~     the efficacy and safety of coenzyme Q10 in treating muscle aches/pain in patients already~     taking statins who develop these symptoms.~   "
226699|NCT00590395|"~     This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission~     tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a~     direct method of detecting infection and/or inflammation of the gallbladder.~   "
226700|NCT00590382|"~     Expanded access to the AMPLATZER Muscular VSD Occluder~   "
226701|NCT00590369|"~     Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will~     perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing~     changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or~     shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare)~     will be less than or equal to VAC system, (6) Patients will report less pain during dressing~     changes with Versatile One (EZCare).~   "
226702|NCT00590356|"~     This study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular~     Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal~     STS Plus (St. Jude Medical).~   "
226703|NCT00590343|"~     The purpose of this study is to examine if PTK787/ZK222584 (vatalanib) will stabilize or~     decrease rising biochemical markers along with progressive disease or syndrome symptoms in~     patients with metastatic neuroendocrine tumors.~   "
226704|NCT00590330|"~     The purpose of this study is to identify all the bacterial species present in the respiratory~     tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information.~     Traditional culture methods of throat swab and sputum samples can only identify the most~     prevalent bacteria in samples, those of which there are over about 5 million bacteria per~     teaspoon. A recently developed method has been found to be more sensitive and can detect up~     to several hundred bacterial species in throat swab or sputum sample of individual CF~     patients.~   "
226705|NCT00590317|"~     This study will compare the effect of prochlorperazine and ondansetron for the treatment of~     nausea and vomiting in the emergency department.~   "
226706|NCT00590304|"~     The purpose of the study is to evaluate asthma and examine the homes of children with asthma~     living in rural areas of the state. This study is being done to give investigators more~     information about the presence of allergens and endotoxin in the homes of children with~     asthma living in the delta region of Arkansas.~   "
226707|NCT00590291|"~     The purpose of this study is to discover genes that may cause Coronary Artery Disease (CAD)~     or Arteriovenous Malformation (AVM).~   "
226708|NCT00590278|"~     The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination~     with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response~     rate and increasing the resectability of initially inoperable rectal cancer.~   "
226711|NCT00590239|"~     -  The use of high resolution endoscopy (HRE), narrow band imaging (NBI) and~          chromoendoscopy increases the detection rates of Barrett's esophagus (BE) and early~          neoplasia.~        -  Endoscopic mucosal resection (EMR) will improve the accuracy for detection of~          dysplasia/early neoplasia.~      Specific Aim 1 - To create a video-atlas of non-dysplastic and dysplastic/early neoplastic~     lesions in patients with BE. This will be used for training purposes and to assess learning~     curve associated with these new technologies.~      Specific Aim 2 - To create a standardized classification system for the mucosal and vascular~     patterns observed in patients with BE.~      Specific Aim 3 - To determine the interobserver agreement using the video-atlas for the~     mucosal and vascular patterns classification agreed upon.~      Specific Aim 4 - To determine the endoscopic detection rate of esophageal cancer or~     precancerous lesions removed during endoscopy.~      Specific Aim 5 - To determine the pathologic and clinical outcomes of patients undergoing~     EMR/ablation; including morbidity, mortality and complications of the procedure.~      Results to date (June 2008) : this study is active and open to enrollment. Currently 26~     patients have enrolled in this study at the Kansas City VA medical center. In order to~     participate, patients must be eligible for care at the KCVA hospital.~   "
226712|NCT00590226|"~     High blood glucose levels in hospitalized patients with diabetes are associated with~     increased risk of medical complications. Improved glucose control with insulin injections may~     improve clinical outcome and prevent some of the hospital complications. It is not known;~     however, what is the best insulin regimen in hospitalized patients. Recently, the use of~     basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart,~     glulisine) has been shown to facilitate outpatient glycemic control with lower rate of~     hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will~     determine the efficacy and safety of the combination of detemir and aspart insulin in the~     inpatient management of subjects with diabetes. We hypothesize that in patients with type 2~     diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus~     insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic~     events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a~     long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a~     rapid-acting insulin which is given subcutaneously several times a day and frequently before~     meals. Detemir and aspart insulins are approved for use in the treatment of patients with~     diabetes by the FDA.~      This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta~     and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will~     serve as principal investigator. A total of 65 patients will be recruited at Grady and 65~     patients at the Rush University Medical Center, Chicago, IL.~   "
226713|NCT00590213|"~     The primary objective of this trial is to examine the value of prophylactic versus~     therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast~     pain. Patients will receive either prophylactic radiotherapy to the breast at a dose of 12Gy~     (as two fractions of 6 Gy in consecutives days), or will not receive any radiotherapy prior~     to commencing CASODEX 150mg monotherapy.~   "
226714|NCT00590200|"~     This proposal delineates a research plan to collect blood from the patients undergoing heart~     catheterization or have had a heart catheterization within one year, coming in for outpatient~     appointments, or have scheduled cardiac CT scans at the Cleveland Clinic over a five-year~     period for the purpose of establishing a gene bank registry. The University of North Carolina~     at Chapel Hill will enroll 1,000 non-Caucasian patients. MetroHealth Medical center in~     Cleveland will enroll 1,000 non-Caucasian patients. The blood collected will be processed to~     create a repository of DNA, lymphoblastoid cell line immortalization on selected patient~     populations, plasma and serum. The DNA will be amplified in certain patient populations to~     preserve the quantity. Along with a sample of blood collected from individual patients, a~     concise general medical history, demographic data, electrocardiographic data,~     echocardiographic data (available for about 55% of patients at the present time), and~     laboratory data will be collected. A short interview will take place after enrollment during~     the outpatient visit or hospital stay, or may be conducted via phone call after enrollment.~     All the clinical data gathered will be compiled in GATC heart center database, and would be~     stored in a format where a culmination of clinical findings, i.e. representing a disease of~     interest, can be used to search the database to identify the blood samples of all patients~     with such characteristics for further study.~   "
226715|NCT00590187|"~     The main objective of this study is to learn which sapacitabine treatment is more likely to~     keep the cancer in check for at least one year in AML patients who are at least 70 years of~     age or older and in MDS patients who are at least 60 years of age.~   "
226716|NCT00590174|"~     The purpose of ZEST-LATE (Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent,~     Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late~     Coronary Arterial Thrombotic Events) trial is to assess the relationship between long-term~     clopidogrel use beyond 1 year and long-term rates of death or MI after DES implantation and~     to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic~     events.~   "
226717|NCT00590161|"~     One third of the population in the United States has nonalcoholic fatty liver disease~     (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to~     cirrhosis.Currently, there is no proven therapy for patients with NASH. The investigators~     core hypothesis is that therapy of patients with NASH with pentoxifylline (PTX) for one year~     will result in improvement of biochemical parameters of liver disease and hepatic histology.~     The focus of this proposal is on the effectiveness of pentoxifylline (PTX) in improving~     laboratory and tissue parameters of liver disease, parameters of insulin-resistance, and~     levels of cytokines in patients with NASH.~   "
226739|NCT00589849|"~     T-wave alternans is an electrocardiographic finding that has been shown to predict the~     occurrence of future cardiac arrhythmias in patients who have had a heart attack. What is~     unknown about T-wave alternans testing is when is the best time to perform the test. In most~     studies, T-wave alternans testing is conducted 4 weeks or more after a heart attack. It is~     unknown if T-wave alternans testing performed prior to hospital discharge in heart attack~     patients is reliable. The objective of this project is to determine the diagnostic accuracy~     of T-wave alternans testing performed prior to hospital discharge and again at 30 days after~     hospital discharge in patients who have suffered a heart attack.~   "
226718|NCT00590148|"~     The purpose of this study is to evaluate the FIM™ as a measure of daily function in children~     with sickle cell disease hospitalized with vasoocclusive pain. Currently, the standard for~     pain assessment is a rating of pain intensity, as determined by observation (for younger~     children) or self-report (for older children and adolescents). However, these measures of~     pain intensity are not effective in recurrent or chronic pain states, and in sickle cell~     disease in particular. Pediatric patients who are hospitalized with vasoocclusive pain often~     do not report a decrease in pain intensity; however, other indications of clinical status,~     such as ambulation, less use of opiates from the patient-controlled analgesia (PCA) pump,~     increased food intake, and transition to oral pain medication, signify that the patient may~     be improving. As a result of our inability to get an accurate picture of the patients'~     condition, we would like to have a summary of improvement that would reflect these changes in~     clinical status and reflect the reduced impact of sickle cell pain on the patient's life. In~     this study, we plan to evaluate a standardized functional assessment measure in pediatric~     patients with sickle cell disease. It is hypothesized that FIM™ scores will correlate with~     other indicators of clinical status, such as movement, quality of sleep, use of IV opiates~     from the patient-controlled analgesia (PCA) pump, and use of intravenous vs. oral pain~     medications. It is also hypothesized that the FIM™ will demonstrate adequate responsiveness~     to change in functional status within a 3-7 day hospitalization by a progressive increase in~     scores and associations with other indicators of clinical improvement.~   "
226719|NCT00590135|"~     The purpose of this study is to find out if an approved medicine that is used to lower~     cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve~     in patients with a condition called aortic stenosis. Patients who have aortic stenosis who~     volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a~     physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of~     the heart) at the start of the study and every 6 months, stopping at 2 years.~   "
226720|NCT00590122|"~     To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth,~     works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.~   "
226721|NCT00590109|"~     The purpose of this project is to further characterize inherited predisposition to breast~     cancer mediated by specific BRCA alleles (BRACA1 185delAG and 5382insC; BRCA2 6174delT) among~     Jewish women.~   "
226722|NCT00590096|"~     I-123-MIBG is used to image patients with neuroblastoma, pheochromocytoma and other neural~     crest tumors~   "
226723|NCT00590083|"~     The main purpose of this study is to see if these T-lymphocytes are safe. To make these~     Ad-specific T lymphocytes the investigators will obtain blood from the stem cell donor and~     transfer Ad into another type of blood cell, called monocytes. These cells can then stimulate~     the T lymphocytes and train them to kill cells infected with Ad. The investigators will then~     grow these Ad-specific T lymphocytes by more stimulation with Ad-infected monocytes and a~     third type of blood cell called a B lymphoblast from the donor. After testing the T~     -lymphocytes, the investigators will inject them into patients after transplant who are at~     high risk of serious Ad virus infection. The investigators will make sure the injected cells~     are safe and see if they affect the growth and behavior of adenoviruses in the patient's own~     body.~   "
226724|NCT00590070|"~     The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in~     acute myocardial infarction is described in up to 40% of cases. This event is associated with~     a worse prognosis at follow up and an unfavourable left ventricular remodelling . Two main~     pathogenetic mechanisms cause no-reflow: distal embolization and ischemia-reperfusion injury.~      Due to the multifactorial pathogenesis of no-reflow during acute MI a combined mechanic and~     pharmacologic approach is believed to offer a better solution for achieving optimal~     microvascular reperfusion. Thus, in this randomized study we will assess the effect of~     nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and~     IIb-IIIa antagonists) for ST elevation MI using ST segment resolution on standard 12 leads~     ECG as primary endpoint of myocardial reperfusion.~   "
226725|NCT00590044|"~     Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes. With an~     estimated 100,000 admissions per year in the United States, DKA is also the leading cause of~     death in children with type 1 diabetes, and accounts for a significant proportion of~     admissions in adult patients with type 1 and type 2 diabetes. The mainstay in the treatment~     of DKA involves the continuous intravenous (IV) infusion of regular insulin or the frequent~     subcutaneous (SC) injections of regular or rapid-acting insulin analogs. Multiple studies~     have reported successful protocols for insulin administration during the acute management of~     DKA, but they have failed to address the transition phase from IV to SC maintenance insulin~     regimen. The American Diabetes Association (ADA) position statement recommends the use of~     split-mixed insulin combination of regular and intermediate-acting insulin (NPH). This~     regimen, however, are associated with a high rate of hyperglycemia shortly after~     discontinuation of IV insulin and a risk of hypoglycemia during the hospital stay. Recently,~     the long-acting basal insulin glargine (Lantus®, Sanofi Aventis Pharmaceuticals) has been~     shown to facilitate glycemic control with lower rate of hypoglycemic events than~     intermediate-acting insulin in subjects with type 1 and type 2 diabetes. This study aims i)~     to determine the effects of giving a dose of glargine insulin shortly after starting an~     intravenous insulin infusion on glycemic control, time to resolve DKA, and rate of~     hypoglycemia in patients with DKA, and ii) to compare the safety and efficacy of basal/bolus~     (glargine/glulisine) insulin versus the standard split-mixed insulin regimen of NPH and~     regular insulin after the resolution of DKA. The hypothesis is that basal (lantus®) insulin~     as compared to NPH insulin shortly after the start of insulin infusion will improve inpatient~     glycemic control in patients with DKA.~      This investigator initiated research will be conducted at Grady Memorial Hospital, Atlanta~     and at University of Minnesota, MN. Dr Umpierrez designed the study and will serve as~     principal investigator. A total of 40 patients will be recruited at each site.~   "
226726|NCT00590031|"~     Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive~     six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4~     and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy~     with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of~     radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of~     chemoradiotherapy.~   "
226740|NCT00589836|"~     The purpose of this study is to learn about the twisting or wringing motion of the heartbeat~     called Left Ventricular Torsion (LV Torsion) which can be seen on ultrasound.~   "
226741|NCT00589823|"~     Cancer patients taking regular medication for their pain often still have episodes of severe~     pain that 'break through' despite their background pain treatment. Fentanyl is a strong,~     short-acting painkiller often used to treat this 'breakthrough' pain. Nasalfent contains~     fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal~     spray. This study will test the efficacy and safety of Nasalfent compared to Immediate~     Release Morphine Sulphate in the treatment of breakthrough cancer pain.~   "
226727|NCT00590018|"~     Babies having heart surgery often have problems after surgery with their blood pressure and~     getting enough blood to their bodies. To treat this they require medicines to keep their~     blood pressure high enough to get blood to their bodies. The side effects of these medicines~     include fast heart rates and increasing the amount of work the heart has to do.~     Corticosteroids are made by the body and help to use the energy in the food people eat,~     control the chemicals in their blood and maintain their blood pressure. Corticosteroids made~     by the body may be decreased in patients that have major surgery. Corticosteroids help to~     increase blood pressure and can decrease the amount of blood pressure medicines a patient~     requires. Corticosteroids have been shown to increase blood pressure in patients with~     bacterial infections and in very small, premature babies but have only been studied in a few~     babies who have had heart surgery. The way corticosteroids work is unknown but may involve~     decreasing the body's response to being on a heart-lung machine or give steroids not being~     made by the patient.~      Corticosteroids have been shown to be helpful in treating many diseases. The purpose of this~     study is to look at the effects of corticosteroids in babies who have had heart surgery and~     need blood pressure medicines in the intensive care unit after surgery. Our idea is that~     getting corticosteroids will allow us to decrease the amount of blood pressure medicines each~     patient needs and improve how they do after surgery. We also plan to do blood tests to help~     determine how the corticosteroids are working.~      It will be randomly determined if the subject receives corticosteroids or salt water. The~     subject will receive a corticosteroid or salt water once a day for five days. Their vital~     signs will be monitored, especially blood pressure and their need for medicines to increase~     their blood pressure. Blood work will also be obtained to determine their body's ability to~     make steroids.~   "
226728|NCT00590005|"~     Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there~     is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the~     airways~   "
226729|NCT00589992|"~     To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide~     will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of~     this study is that ibutilide will decrease the high frequency signals observed in Afib~     suggesting the presence of micro reentrant circuits as the basic mechanism of Afib,~     especially for the paroxysmal Afib group. The potential difference in response to the~     ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the~     underlying mechanism of Afib between these two groups.~   "
226730|NCT00589979|"~     Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from~     their current analgesic regimen will participate in a pilot clinical trial to evaluate the~     effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee~     pain from OA.~   "
226731|NCT00589966|"~     This study will test the effectiveness of an 8-week group intervention for African American~     men who have been treated for prostate cancer. The group intervention is based on 1) the~     cognitive-behavioral theoretical approach to improving adjustment to cancer and 2)~     masculinity theory as it relates to coping strengths and preferences in men. We will test the~     effectiveness of this coping skills intervention for improving survivors' quality of life in~     4 areas: 1) distress related to sexual, urinary, and bowel symptoms; 2) self-confidence for~     managing symptoms; 3) overall emotional functioning; and 4) overall physical functioning. The~     effect of the coping skills group intervention in these 4 areas will be compared to a~     comparison intervention in which African American men will receive basic education about~     prostate cancer, but will not participate in coping skills training.~   "
226732|NCT00589953|"~     The highest risk for perinatal brain injury occurs among extremely premature infants who~     weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible,~     associated with neurodevelopmental disability, and without adequate treatment modalities.~     Research in recent years suggest in both animal and human studies that erythropoietin (Epo)~     may have significant neuroprotective effects. Given the historical safe medical profile of~     Epo when used for anemia of prematurity but the likely need for a greater dosage regimen for~     activation of neuroprotective pathways against neonatal brain injury, we therefore propose~     this phase II study of high-dose Epo in very low birth weight infants for the prevention~     and/or attenuation of prematurity-related cerebral hemorrhagic-ischemic injury.~   "
226733|NCT00589927|"~     To evaluate whether the cilostazol reduce neointimal hyperplasia after ZES~     (Zotarolimus-eluting stents) implantation, the investigators performed~     double-blind,randomized, multicenter, prospective study compared triple antiplatelet therapy~     (aspirin plus clopidogrel plus cilostazol) and dual antiplatelet therapy (aspirin plus~     clopidogrel) for 8 months in patients with long coronary lesion treated with ZES.~   "
226734|NCT00589914|"~     The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in~     patients with Schizophrenia.~   "
226735|NCT00589901|"~     The primary objective of this study is to evaluate the time to progression. Secondary~     objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into~     this study.~   "
226736|NCT00589888|"~     Insulin resistance has been implicated as the central mechanism in the development of several~     cardiovascular risk factors including hypertension, diabetes, lipid disorders, and~     coagulation disorders. Recent evidence suggests that increased levels of a circulation fat~     (free fatty acids or FFAs) are a leading candidate causing insulin resistance. Our~     preliminary studies in indicate that, in addition to insulin resistance, the infusion of~     Intralipid and heparin to increase FFAs resulted in a significant rise in systolic and~     diastolic blood pressure, impaired endothelial (vascular) function, and increased~     inflammatory markers in obese African Americans with and without diabetes. The effects of FFA~     on insulin action are well established; however, the blood pressure and vascular effects of~     FFAs infusion in obese subjects have not been fully investigated. We hypothesize that~     observed changes in blood pressure are the result of acute endothelial dysfunction, and/or~     increased activation of the autonomic nervous system. No previous studies have attempted to~     determine a dose response effect of increasing FFA on blood pressure. In addition, it is not~     know if increased FFAs by repeated oral fat load results in similar blood pressure than~     intravenous lipid infusion. Accordingly, we propose: 1) a systematic evaluation of the~     effects of increasing FFA levels on blood pressure and endothelial (vascular) function, and~     2) determine the effects of comparable increases in FFA concentration via intravenous~     infusion of Intralipid or by repeated oral fat load on blood pressure, insulin resistance and~     endothelial dysfunction in obese subjects.~      A group of 10 obese normotensive subjects will be admitted to the Grady Clinical Research~     Center or to the Outpatient Research Unit in the Grady Diabetes Clinic on five occasions. In~     four of these admissions, research subjects will receive an 8-hour intravenous infusion, in~     random order, of increasing Intralipid concentration (10 ml, 20 ml, 40 ml per hour) or normal~     saline (40 ml per hour). During the final admission, research subjects will receive an oral~     liquid fat diet every 2 hours for 8-hours. The effect of increased FFAs on blood pressure and~     endothelial (vascular) function via intravenous infusion and via oral fat load therapy will~     be assessed.~   "
226737|NCT00589875|"~     The purpose of this study was to evaluate the safety and potential efficacy of Gene Mediated~     Cytotoxic Immunotherapy for malignant gliomas. The approach used an adenoviral vector~     (disabled virus) engineered to express the Herpes thymidine kinase gene (aglatimagene~     besadenovec, AdV-tk), followed by an antiherpetic prodrug, valacyclovir. The AdV-tk vector~     was injected into the resection bed after standard tumor surgery and valacyclovir pills were~     taken for 14 days. Standard radiation and chemotherapy were administered which have been~     shown to work cooperatively with AdV-tk + prodrug to kill tumor cells. The hypothesis is that~     this combination therapy can be safely delivered and will lead to improvement in the clinical~     outcome for patients with newly diagnosed malignant gliomas, including glioblastoma~     multiforme (WHO grade IV) and anaplastic astrocytomas (WHO grade III).~   "
226742|NCT00589810|"~     In this replication study at the Cleveland Clinic, we seek to collaborate to validate~     findings of the CardioGene Study in an independent cohort of patients who have undergone bare~     metallic stenting.~   "
226744|NCT00589784|"~     The purpose of this study is to find out what effects, good and/or bad, sunitinib has on~     patients and their tumors. At this time, no drugs are routinely used to treat meningioma,~     hemangioblastoma or hemangiopericytoma. Only surgery and radiation therapy are known to be~     useful.~      Sunitinib is a drug approved for advanced kidney cancer. Sunitinib is also being studied for~     other tumors. It may be useful in the treatment of brain tumors because it can prevent~     formation of new blood vessels that allow tumor cells to survive and grow.~   "
226745|NCT00589771|"~     Various studies have been conducted in past using different strains of probiotics in~     evaluating IBS symptoms. The results are by no means consistent and the overall impact of~     probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that~     Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was~     associated with normalization of the ratio of an anti-inflammatory to a proinflammatory~     cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this~     disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the~     antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It~     ameliorates intestinal injury and inflammation caused by a wide variety of enteric~     pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess~     the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant~     IBS and its effect on quality of life. We also plan to assess the changes in the relative~     production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8~     and TNFα).~   "
226746|NCT00589758|"~     The primary purpose of this study is to learn if taking pictures of your heart using two~     dimensional and three dimensional echocardiography in the heart failure intensive care unit~     can be helpful to understanding how the heart is working.~      All research subjects will be adults admitted to the heart failure ICU with acute~     decompensated heart failure and requiring monitoring of their heart function using a catheter~     that is placed in the pulmonary artery which is a blood vessel. In this situation, use of the~     pulmonary artery catheter,or PAC, is considered standard clinical care. It is not a research~     procedure. The PAC would be used even if you were not participating in this research project.~      All research subjects will be evaluated at the time they are admitted to the ICU, 24 to 48~     hours after admission to the ICU, and 7 days after leaving the ICU. At all three time points,~     we will be taking pictures of the heart using the two dimensional and three dimensional~     echocardiogram.~      Additionally, at each time-point, we will collect a blood sample of approximately two and a~     half tablespoons each time, and a urine sample. We will be testing the sample for biomarkers~     of heart failure which are proteins and enzymes specifically related to heart function. We~     will not be conducting any genetic research on the sample. Any extra blood from these~     research tests will not be saved for future research.~      We will also be looking at the data that is collected by the pulmonary artery catheter. The~     catheter has a sensor on it that measures things like blood flow and pressure in the heart.~      At the Day 7 post discharge visit there will be a six minute hall walk so that we can access~     the distance that you can walk. We will access any symptoms that you may experience. A nurse~     or physician will monitor the six minute hall walk.~      The research information that we collect on you will not be placed in your medical record.~     The data is for research purposes only.~   "
226747|NCT00589745|"~     The purpose of this research study is to provide a novel method for the diagnosis of Cystic~     Fibrosis (CF). This protocol is designed to test the ability of the cells to regulate the~     movement of salt and water in people with features of CF in whom the diagnosis is not~     entirely clear. We will be studying these cells in the nose, by a technique called nasal~     transepithelial potential difference (NPD).~   "
226748|NCT00589732|"~     To evaluate that angiotensin-converting enzyme (ACE) inhibitors and angiotensin-converting~     enzyme receptor blockers (ARBs) reduce the risk of restenosis after DES implantation.~   "
226749|NCT00589719|"~     The purpose of the study is to conduct a cross-sectional study to examine asthma prevalence~     and morbidity in a predominately minority, low-income population in rural Arkansas.~   "
226750|NCT00589706|"~     Data from the wistar institute indicated that this anti-body labeled with iodine-125 would~     localized in the tumor cells of high grade gliomas of the brain. the project combines~     surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase II~     trial in this disease entity.~   "
226751|NCT00589693|"~     The purpose of this study is to show that doripenem is as effective as imipenem-cilastatin in~     the treatment of patients with ventilator-associated pneumonia.~   "
226752|NCT00589680|"~     At this time, Saint Mary's Medical Center is currently in the process of implementing a~     standardized diabetic ketoacidosis (DKA) protocol. The first main goal of this project will~     be to evaluate patient outcomes to determine the effects of treating patients without a~     standardized protocol and to establish a baseline on how patients are being treating with~     DKA. The final goal of the project will be to compare outcomes of those patients not placed~     on the protocol to those that were treated using SMMC newly implemented DKA protocol. The~     overall goal of this project is to determine the benefit of an institutional DKA protocol.~   "
226753|NCT00589667|"~     The purpose of this study is to determine if the combination of 2 chemotherapy drugs called~     pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell~     cancer. The researchers want to find out what effects, good and/or bad, that this treatment~     has on head and neck cancer.~   "
226754|NCT00589654|"~     Very little is known about the incidence, onset, time course, and symptomatology of premature~     menopause induced by breast cancer therapy. No prospective study exists. The purpose of the~     present study is to identify determinants of treatment-related amenorrhea nad its effect on~     quality of life in a cohort of youg breast cancer patients.~   "
226755|NCT00589641|"~     The purpose of this study is to develop, refine, and pilot test an augmenting cognitive~     behavior relapse prevention intervention (CBT-RP) for suicidal, depressed, and~     alcohol/substance abusing adolescents. No hypotheses are being tested, but it is expected~     that CBT-RP in addition to treatment as usual will result in improved outcomes relative to~     treatment as usual alone.~   "
226756|NCT00589628|"~     The primary objective of this study is to examine the efficacy of infliximab for the~     treatment of persistent uveitis in children. Participants (4-18 years of age) will be~     randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by~     intravenous infusion at four week intervals. Participant responses will be measured at at~     four to eight week intervals for up to ten months.~   "
226757|NCT00589615|"~     The study will elucidate the effectiveness of an educational program in the prevention of~     osteoporosis and fractures. A random sample of the female population in Southern Finland~     (Uusimaa region) within the age group of 60-70 years was drawn from the population registry.~     From 1996 through 2000, 2181 women from the population register were recruited and randomly~     assigned to the intervention and to the control group. The subjects in the intervention group~     have been on a multidisciplinary program and the subjects in the control group received~     osteoporosis prevention information through the media and health care system. An end point is~     any fracture during the ten-year follow-up.~   "
226758|NCT00589602|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood~     stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the~     patient's immune system from rejecting the donor's stem cells. When stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor~     can make an immune response against the body's normal cells. Removing the T cells from the~     donor cells before transplant may stop this from happening. Giving an infusion of the donor's~     T cells (donor lymphocyte infusion) after the transplant may help destroy any remaining~     cancer cells (graft-versus-tumor effect).~      PURPOSE: This phase II trial is studying T-cell depletion in donor stem cell transplant~     followed by delayed T cell infusions in treating patients with hematologic cancer or other~     disease.~   "
226759|NCT00589589|"~     This study is intended to fill the knowledge gap regarding the burn population with research~     that achieves scientific merit. we will determine the effectiveness of the computer decision~     support system (CDSS) to facilitate glucose management in the critically ill burn patient.~      The EndoTool™ computer decision support system will achieve glycemic control (defined as~     80-110 mg/dL) in a shorter time, reduce glycemic excursion outside of target range, and~     reduce incidence of hypoglycemia (blood glucose less than 50 mg/dL) in the critically ill~     burn patient compared to the standard of care USAISR insulin titration protocol (Appendix A).~   "
226760|NCT00589563|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood~     stem cell transplant helps stop the growth of cancer cells. It also stops the patient's~     immune system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving tacrolimus, sirolimus, antithymocyte globulin, and~     methotrexate before and after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte~     globulin work in preventing graft-versus-host disease in patients undergoing a donor stem~     cell transplant for hematological cancer .~   "
226761|NCT00589550|"~     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may~     also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving~     PEG-interferon alfa-2b together with sorafenib may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon~     alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.~   "
226762|NCT00589537|"~     RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not~     yet known which MRI or CT scan schedule is more effective in finding recurrent cancer.~      PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan~     schedules in patients with stage I seminoma of the testicle.~   "
226763|NCT00589524|"~     To compare results of Intravascular Ultrasound (which occurs during cardiac catheterization)~     with Computed Tomography (CT) scan to detect blockages or narrowing of the arteries that feed~     the heart. These will be studied in the cardiac transplant population.~   "
226764|NCT00589511|"~     The objective of this multisite study is to evaluate the performance of the Nucleus Freedom~     cochlear implant system in a large population of sequentially implanted pediatric subjects.~   "
226765|NCT00589498|"~     Understanding the mechanisms of obesity-induced hypertension is important both for prevention~     and therapy. Studies of patients with established obesity have provided valuable information~     on pathophysiologic links between obesity and both blood pressure and cardiovascular risk.~     However, these studies are necessarily limited by the heterogeneity of obesity-associated~     disease so that the relative contribution of obesity or hypertension or other co-existing~     diseases to specific regulatory abnormalities is often not clear. Clarification of whether~     any abnormalities associated with increased cardiovascular risk were present before or after~     the development of obesity has also been problematic.~      We therefore propose a series of novel studies directed at establishing the effects of~     increased body fat in otherwise healthy individuals. We will determine the distribution~     patterns of increased body fat and how both increased body fat and fat distribution relate to~     changes in blood pressure, and in neural, endothelial and inflammatory mechanisms which have~     been implicated in the development and progression of cardiac and vascular disease.~      We will study non-obese subjects with and without a family history of hypertension. These~     subjects will undergo an eight-week program of overfeeding with the objective of inducing a 4~     kg fat gain. We will determine the nature of fat distribution in these individuals after the~     fat gain program and subsequently after an eight-week period of weight loss and restoration~     of normal body weight. Measurements will be compared to those obtained in a matched control~     group with and without a family history of hypertension, who will continue their normal~     diets. We will test the following hypotheses:~        -  Individuals with a family history of hypertension will gain more visceral fat and upper~          body subcutaneous fat and will have greater blood pressure increases with overfeeding-~          compared with those without such a family history.~        -  For all overfed subjects, increases in blood pressure and insulin resistance with fat~          gain will be most marked in those individuals with a predominantly upper body and~          visceral fat accumulation.~        -  Upper body and visceral fat gain will also be associated with greater impairment in~          cardiovascular function, higher nocturnal blood pressures and an increased likelihood of~          sleep disordered breathing.~   "
226766|NCT00589485|"~     The purpose of this study is to collect radiographic and clinical outcomes of total knee~     replacement using Simplex® or Cobalt™ Bone Cement.~   "
226767|NCT00589472|"~     This phase II trial studies how well androgen deprivation therapy and vorinostat followed by~     radical prostatectomy works in treating patients with prostate cancer that has not spread to~     other parts of the body. Androgens can cause the growth of prostate cancer cells. Antihormone~     therapy, such as bicalutamide, goserelin acetate, and leuprolide acetate, may lessen the~     amount of androgens made by the body. Vorinostat may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving androgen deprivation therapy and~     vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~   "
226768|NCT00589459|"~     The primary goal of this study is to measure the prevalence of undiagnosed~     pre-diabetes/diabetes among women hospitalized with acute coronary syndromes (ACS) compared~     to men. Inpatients with confirmed ACS (and no known prior history of diabetes) are invited to~     return to the Yale Hospital Research Unit 6-8 weeks after hospital discharge for an oral~     glucose tolerance test to identify individuals with pre-diabetes and diabetes.~   "
226769|NCT00589446|"~     The purpose is to test the value of embryoscopy in women with missed abortions after~     recurrent miscarriages (at least two previous miscarriages) in the past. This project will~     assess two functions of embryoscopy:-~        1. Whether embryoscopy allows the diagnosis of structural anomalies (disorganized embryos).~          This is a fetal cause of embryo loss which cannot be diagnosed by other means.~        2. Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.~      However, it may be that embryoscopy will be found to have no advantage.~   "
226770|NCT00589433|"~     Rotator culf tears are common in the aging population and are a significant morbidity source.~     The common knowledge is that the major tears do not heal and constantly expanding.Still since~     the majority of the patients are old the acceptable therapy is conservative treatment.~      Our objective is to estimate the accuracy of rotator culf tear utilizing an ultrasound.~   "
226771|NCT00589420|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving sorafenib together with docetaxel may kill more tumor cells.~      PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how~     well it works in treating patients with metastatic androgen-independent prostate cancer.~   "
226772|NCT00589407|"~     Neck pain is a common complaint in the general population affecting 10-15% of the general~     population. females more than men. Known risk factors are: Trauma, Repetitive lifting of~     heavy objects at work, driving vibrating vehicles, frequents diving from boards and smoking.~     No study dealt with the possible role of unilateral loss of vision or hearing as a risk~     factor for the development of neck pain. Intuitively, one might suspect that unilateral~     blindness or deafness will lead to a tilted position of the head, in order to cover a better~     visual/audio field. This position, in time, might lead to the development of neck pain.~      Our hypothesis is that patients with unilateral blindness/deafness will suffer from neck pain~     more frequently than the general population.~   "
226773|NCT00589394|"~     The lack of clear guidelines and studies addressing the proper response to the pneumococcal~     vaccine (Pneumovax ®) has hampered our ability to diagnosis and care for our immunodeficiency~     patients. Should an age matched normal response range to the Pneumovax ® be established, it~     would have a profound impact in the diagnosis, safety and care of immunodeficiency patients.~     Moreover, characterizing the B cell compartments response to the Pneumovax ® may better~     delineate the mechanism of protective immunity from Pneumovax ® and provide an additional~     tool for the diagnosis and care for immunodeficiency patients.~   "
226774|NCT00589381|"~     RATIONALE: Drugs used in chemotherapy, such as fenretinide Lym-X-Sorb™ , work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide~     Lym-X-Sorb™ in treating patients with recurrent or resistant solid tumors or lymphoma.~   "
226775|NCT00589368|"~     The purpose of this study is to examine if the strong hand can assist in the recovery of~     muscle function in the weak hand after a stroke.~   "
226776|NCT00589355|"~     The goal of this study is to determine whether markers of vascular inflammation (such as~     c-reactive protein) can predict endothelial dysfunction (as measured by flow-mediated~     dilation) in postmenopausal women with glucose intolerance compared to normal controls.~   "
226777|NCT00589329|"~     Preterm birth, its causes, prevention, complications and ramifications persist as an~     important focus of obstetrical research. In the United States 11.8% of all live births occur~     prior to 37 weeks gestation. As many as 45% of these deliveries will have been proceeded by~     preterm labor with intact membranes.(2) Both preterm labor and preterm premature rupture of~     membranes have both been associated with evidence intrauterine infection. While antibiotic~     treatment in conservative management of preterm PROM remote from term has been shown to~     significantly prolong pregnancy and reduce infant morbidity, (16) data regarding the~     effectiveness of antibiotics for pregnancy prolongation in preterm labor are inconsistent.~     (3-15) Currently, narrow spectrum antibiotics (penicillin or clindamycin) are given prior to~     delivery to reduce the risk of neonatal Group B Beta Streptococcus (GBS) sepsis, however~     broad spectrum antibiotic treatment of women with preterm labor for pregnancy prolongation is~     not recommended.~      Review of the literature regarding antibiotic treatment for pregnancy prolongation in preterm~     labor reveals that most studies utilized single agent therapy, and no study has evaluated the~     use of antibiotics for pregnancy prolongation in women with an advanced cervical exam (>4cm).~     While a number of studies have shown significant pregnancy prolongation in unselected~     populations,(5,12,13) only one study of 12 reviewed was able to show a neonatal benefit to~     adjunctive antibiotic use.(12,20) Norman, et al was able to show a reduction in the incidence~     of necrotising enterocolitis with the use of antibiotics. Given the number of studies in this~     area, and the lack of supporting evidence, this likely represents an alpha error. Another~     study by Svare et al was able to show a significant decrease in NICU admissions for women~     treated with antibiotics in the setting of preterm labor, however no change was reported in~     neonatal morbidities.~      Our proposed study is designed to evaluate patients at particular risk for preterm delivery;~     those with advanced cervical exam. In this randomized prospective controlled study, we intend~     to examine the influence of adjunctive antibiotic use in preterm labor complicated by a~     cervical exam of 4 cm or greater. We plan to compare a study group receiving broad-spectrum~     antibiotics with a control group that will not receive antibiotics for pregnancy~     prolongation. Both groups will receive antibiotics for GBS prophylaxis as indicated. We hope~     to see a delay in delivery in the study group as a primary outcome. Secondary outcomes will~     include the use of steroids, neonatal complications including sepsis, intraventricular~     hemorrhage, periventricular leukomalacea, mechanical ventilation and respiratory distress~     syndrome, retinopathy of prematurity and necrotizing enterocolitis, and neonatal ICU stay.~   "
226778|NCT00589316|"~     This phase I trial studies the side effects and best dose of iodine I 131monoclonal antibody~     BC8 when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation,~     and donor bone marrow transplant, and to see how well they work in treating patients with~     acute myeloid leukemia or acute lymphoblastic leukemia that has spread to nearby or other~     places in the body (advanced), or high-risk myelodysplastic syndrome. Giving chemotherapy~     drugs, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before~     a donor bone marrow transplant helps stop the growth of cancer or abnormal cells and helps~     stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled~     monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells~     and carry cancer-killing substances to them without harming normal cells. When the healthy~     stem cells from a donor are infused into the patient they may help the patient's bone marrow~     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving cyclophosphamide together with mycophenolate mofetil and tacrolimus after the~     transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together~     with donor stem cell transplant, fludarabine phosphate, cyclophosphamide, mycophenolate~     mofetil, and tacrolimus may be an effective treatment for advanced acute myeloid leukemia,~     acute lymphoblastic leukemia, or myelodysplastic syndromes.~   "
226779|NCT00589303|"~     The purpose of this study is to determine whether early atrioventricular node (AVN) ablation~     with pacing device therapy will reduce death and hospitalization when compared to the~     conventional drug therapy in elderly patients with recurrent and symptomatic atrial~     fibrillation (AF).~   "
226837|NCT00588471|"~     The goal of this study is to determine if one dose of simvastatin will decrease the~     inflammatory response to coronary intervention. Also to determine if one dose of simvastatin~     affects endothelial function (activity of the artery) as measured by noninvasive peripheral~     artery tonography.~   "
226780|NCT00589290|"~     Background:~        -  Cisplatin-containing chemotherapy is the standard treatment for advanced tumors of the~          thymus that cannot be removed surgically.~        -  New treatment options are needed for patients with advanced tumors of the thymus that do~          not improve with cisplatin-containing therapy.~        -  Belinostat is a drug that inhibits enzymes called histone deacetylase. Histone~          deacetylase inhibitors have shown promising activity in many cancers and may be useful~          in treating patients with thymic tumors.~      Objectives:~      -To assess the safety and effectiveness of belinostat for treatment of malignant thymic~     tumors in patients who failed after standard treatment.~      Eligibility:~      -Patients 18 years of age or older with an advanced thymic tumor that has progressed after~     treatment with platinum-containing chemotherapy.~      Design:~        -  Patients receive belinostat treatment in 21-day cycles. The drug is given as an infusion~          through a vein during days 1 through 5 of each cycle. Treatment cycles continue as long~          as the medicine is tolerated and the cancer does not worsen.~        -  Patients have a physical examination and several blood tests during every cycle.~        -  Patients have an electrocardiogram every cycle before starting the belinostat infusion~          and again on the last day of the infusion.~        -  Patients undergo computed tomography (CT) or other imaging test, such as ultrasound or~          MRI, every two cycles to evaluate the response of the tumor to treatment.~        -  Tumor tissue obtained from a previous biopsy is used for research purposes.~   "
226781|NCT00589277|"~     The purpose of this study is to compare Yale coaching counseling and Yale print~     information to standard care counseling and standard care print information. We hypothesize~     that Yale coaching counseling and Yale information will produce higher abstinence rates~     than standard care counseling and standard care information. We will use these data to~     determine effect size estimates for a large scale study.~   "
226782|NCT00589264|"~     Zinc is necessary for growth and development, including the central nervous system, and zinc~     deficiency which is common in resource-poor settings, may adversely affect social,~     behavorial, cognitive and sensorimotor development. The project, located in Lima Peru,~     utilizes an experimental model in which children receive 10 mg supplemental zinc (or not)~     daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age.~     Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in~     multiples aspects of development. Children are also followed for their diet, growth, and~     health status. We hypothesize that children in this setting in which the diet is low in zinc~     who receive supplemental zinc will have better information processing skills, sensorimotor~     and behavioral development than their counterparts who do not receive supplemental zinc.~   "
226783|NCT00589251|"~     The primary objective of the study is to evaluate the equivalency of the skin test reactivity~     to penicilloate prepared by our new method of penicilloate preparation versus our old method~     of penicilloate preparation. The secondary objective of the study is to evaluate the~     significance of the different diastereoisomers of penicilloate on skin test reactivity.~   "
226784|NCT00589238|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, doxorubicin, cyclophosphamide, and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known whether combination chemotherapy~     is more effective with or without carboplatin in treating breast cancer.~      PURPOSE: This randomized phase II trial is studying giving paclitaxel together with~     doxorubicin and cyclophosphamide to see how well it works compared to giving paclitaxel~     together with doxorubicin, cyclophosphamide, and carboplatin in treating women with locally~     advanced breast cancer that can be removed by surgery.~   "
226785|NCT00589225|"~     This study will help us determine whether certain genetic mutations, more than others, are a~     cause of more severe disease in Primary Hyperoxaluria.~   "
226786|NCT00589212|"~     This study has been designed to compile information on the efficacy of the GliaSite RTS~     combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.~   "
226787|NCT00589199|"~     The purpose of the present study is to assess the utility of abdominal muscle stimulation to~     provide large positive airway pressures and expiratory airflow thus simulating cough.~     Restoration of cough in spinal cord injured patients may reduce the incidence of respiratory~     complications such as atelectasis, respiratory tract infections and respiratory failure.~   "
226788|NCT00589186|"~     RATIONALE: Vaccines made from a gene-modified virus and a person's dendritic cells may help~     the body build an effective immune response to kill tumor cells. Celecoxib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine~     therapy together with celecoxib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with~     celecoxib works in treating patients with metastatic nasopharyngeal cancer.~   "
226789|NCT00589173|"~     Americans only receive 50% of indicated preventive services. We hypothesize that an~     interactive preventive health record (IPHR) will increase the delivery of recommended~     screening tests, immunizations, and counseling. The IPHR will function as a highly~     sophisticated personal health record for prevention, linking patients directly to their~     health information in the electronic record of their primary care physician. The functions of~     the IPHR will extend beyond those of personal health records by providing tailored~     recommendations, links to educational resources and decision aids, and patient and clinician~     reminders. Year one will focus on updating and refining an existing IPHR prototype. The~     second and third year, through a randomized controlled trial, will examine the effectiveness~     of the IPHR. Outcomes will include (1) whether the IPHR increases the delivery of recommended~     preventive services, (2) whether participants use the IPHR, and (3) whether the IPHR~     increases shared decision-making and improves clinician-patient communication. The study will~     take place in seven primary care practices in the Virginia Ambulatory Care Outcomes Network~     (ACORN) that utilize a common electronic medical record (EMR). A randomly selected sample of~     5,500 of the practices' 228,000 patients, stratified by age and gender, will be assigned in a~     one-to-one ratio to receive a request from their clinician to use the IPHR (intervention~     group) or receive usual preventive care (control group). A Preventive Services Survey,~     which uses standardized questions to evaluate the delivery of preventive care, will be mailed~     to 4,500 patients and the CAHPS Clinician & Group Survey will be mailed to 1,000 patients.~     Surveys will be mailed pre-intervention, 6 month post-intervention, and 18 months~     post-intervention. Delivery of preventive care will be measured by the Preventive Services~     Survey and EMR data, while shared decision-making and clinician-patient communication will be~     measured by the CAHPS survey. The change from baseline to 6 and 18 months post-intervention~     for the control and intervention groups will be compared.~   "
226798|NCT00589030|"~     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near~     a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be~     effective treatment for liver cancer that cannot be removed by surgery.~      PURPOSE: To provide expanded access and study the side effects of yttrium Y 90 glass~     microspheres in treating patients with liver cancer that cannot be removed by surgery.~   "
227215|NCT00583414|"~     The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm~     exclusion using an endovascular prosthesis.~   "
226790|NCT00589147|"~     SUMMARY A prospective, randomized, single-blinded clinical trial is proposed to compare three~     tibial tray designs for patients undergoing total knee arthroplasty. This study is designed~     to address the clinically important issues of tibial component modularity and fixation in~     total knee replacement. The Zimmer NexGen Legacy knee system is an FDA approved device and in~     this study will be used with 1) a modular tibial tray inserted with cement and 2) a~     non-modular tibial tray inserted with cement, and 3) a non-modular tibial tray inserted~     without cement. The insertion of total knee components without cement has been done~     clinically for over 20 years but has not been specifically approved by the FDA. Thus~     treatment arm 3, a non-modular tray inserted without cement, would involve the so-called~     off-label use of the device.~      136 cases will be assigned to each arm of the study. Each patient will be assessed two months~     after surgery, one year after surgery, two years after surgery, five years after surgery, and~     every three to five years thereafter. The principal outcome measures will be the Knee Society~     Clinical rating scale, the SF-36 and the presence of significant lucent lines.. These~     measures will be compared among patients in the 3 trial arms at 5 years post surgery (or at~     the last follow-up point for those who drop out or become lost to follow-up). The Knee~     Society scores and SF-36 scores will be analyzed using analysis of variance models Rates of~     significant lucencies, perioperative mortality, as well as complications such as deep vein~     thrombosis, pulmonary embolus, neurovascular complication, and infection will be compared~     among the groups using chi-square tests . Rates of revision surgery will be compared among~     the groups using survivorship methods.~      PURPOSE The primary aim of the study is to compare the results obtained with each of three~     tibial designs for patients undergoing total knee arthroplasty. Those results will be~     measured with disease-specific (Knee Society Scores), global (SF-36), and outcome measures.~     Radiographic results consisting of standing alignment, lateral and skyline views of the~     surgical knee will be recorded and analyzed. Completion of the intial investigation will~     occur at the 5-year interval after the last enrolled patient.~   "
226791|NCT00589134|"~     Women are at greater risk for exercise-induced hyponatremia (low blood sodium concentration)~     and this risk has been attributed to their lower body weight and size, excess water ingestion~     and longer racing times relative to men. While these factors contribute to the greater~     incidence of hyponatremia in women, it is likely that their greater levels of estradiol in~     plasma and/or tissue also play a role in increasing the risk of hyponatremia in women. More~     importantly, estradiol may also leave women more susceptible to the extreme consequences of~     hyponatremia (i.e. brain damage, death). Hyponatremia is generally attributed to~     inappropriately elevated levels of the hormone arginine vasopressin (AVP). AVP is the most~     important hormone controlling water retention in the kidney. Earlier studies in our~     laboratory have demonstrated that estradiol lowers the threshold for thirst sensation and AVP~     release during exercise. The purpose of these studies is to test the hypotheses that in women~     with a history of hyponatremia, estradiol lowers the thresholds for thirst and AVP release,~     leading to greater fluid retention, lower blood sodium concentration during endurance~     exercise in the heat. However, we further hypothesize that progesterone administration along~     with estradiol administration will attenuate the effect of estradiol on the regulation of~     thirst and AVP, normalize fluid retention, and serum sodium concentration during endurance~     exercise in the heat. In women without a history of hyponatremia, we expect that estradiol~     administration will lower the thresholds for thirst and AVP release, but will not increase~     fluid retention or reduce blood sodium concentration during endurance exercise in the heat.~     We hypothesize that progesterone administration along with estradiol administration will~     attenuate the effect of estradiol on thirst and AVP, but have no effect on fluid retention or~     serum sodium concentration during endurance exercise in the heat. To test these hypotheses,~     women will perform endurance exercise in the heat under three hormonal conditions: 1) during~     Gonadotropin-releasing hormone (GnRH) antagonist alone--which will suppress estradiol and~     progesterone; 2) during GnRH antagonist+estradiol; and 3) during GnRH antagonist+estradiol+~     progesterone. During exercise, fluid will be replaced with either water or a~     carbohydrate-electrolyte beverage (random assignment).~   "
226792|NCT00589121|"~     RATIONALE: Image-guided radiation therapy uses high-energy x-rays to kill tumor cells.~     Specialized radiation therapy that delivers a lower dose of radiation directly to the tumor~     may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase II trial is studying the side effects and how well image-guided radiation~     therapy works in treating patients with primary soft tissue sarcoma of the shoulder, arm,~     hip, or leg.~   "
226793|NCT00589108|"~     Pain, weakness, instability, and progressive dysfunction are the hallmarks of arthritis of~     the knee. Total knee replacement may frequently be the only therapeutic intervention to~     provide adequate improvement in pain and function. Both fixed bearing and mobile bearing~     knees have a long track record of clinical success. Mobile bearing designs have theoretical~     advantages of decreased contact stresses on the tibial tray, decreased polyethylene wear, and~     improved range of motion relative to fixed bearing designs. These theoretical advantages may~     become especially important in the young patient who requires a knee arthroplasty. This study~     will attempt to see if there is a clinical difference in outcome between mobile bearing and~     fixed bearing knee arthroplasties in patients who require total knee replacement.~   "
226794|NCT00589095|"~     The purpose of this study is to determine whether dynamic contrast enhanced MRI (DCE MRI) and~     high diffusion weighting MRI may be used to distinguish between favorable and unfavorable~     responses to therapy of glioblastoma multiforme. Imaging data will be correlated with~     histopathologic findings and clinical responses to radiation therapy with or without~     chemotherapy.~   "
226795|NCT00589082|"~     Overall results in the treatment of middle aged adults acute myelogenous leukemia (AML) are~     substantially improved in the last decade, with complete remission (CR) rates established to~     values of 70 to 80per cent and also encouraging long-term outcome, especially in patients who~     can tolerate intensified post remissional treatment strategies. On the contrary, there has~     been little progress in the treatment of older patients. In these patients the response rate~     generally range between 40 and 60per cent, and overall survival at 2 years is often less than~     10 per cent.~      Usually, a combination of anthracyclines daunomycin DNR or doxorubicin and cytarabyne Ara-C~     has been utilized for the remission-induction treatment, with schedules similar to those~     utilized in younger cases, for patients eligible to intensive treatments. Variation of the~     dose of DNR has not brought any significant benefit. The EORTC HOVON randomized trial AML9~     compared two drugs in induction for previously untreated patients. DNR versus Mithoxantrone~     (MTZ). MTZ induction therapy produces a slightly better CR rate than DNR-containing regimen~     (47per cent vs 38per cent, P equals 0.069), without any significant effect on remission~     duration and survival. The DFS probability between the two treatment arms was not different.~     The median DFS estimates were 39 weeks in both groups. The DFS rate at 5 years was 8per cent.~     Also the duration of survival was similar (p equals 0.23) in the two treatment groups. Median~     survival estimates were 36 weeks (DNR) and 39 weeks (MTZ). The percentage of patients still~     alive at 5 years were 6per cent and 9per cent respectively.~   "
226796|NCT00589056|"~     RATIONALE: Nelfinavir may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells.~     Nelfinavir may make tumor cells more sensitive to radiation therapy. Drugs used in~     chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir~     together with radiation therapy, cisplatin, and etoposide may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir when~     given together with radiation therapy, cisplatin, and etoposide and to see how well they work~     in treating patients with stage III non-small cell lung cancer that cannot be removed by~     surgery.~   "
226797|NCT00589043|"~     The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system~     when used adjunctively with mammography compared to mammography alone in the heterogeneously~     and extremely dense breast population.~   "
226814|NCT00588796|"~     To study the fibrinogen metabolic changes in relation to coagulation disorder in patients~     with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of~     fibrinogen is accelerated.~   "
226799|NCT00588991|"~     This phase I trial is studying the side effects and best dose of veliparib when given~     together with topotecan hydrochloride with or without carboplatin in treating patients with~     relapsed or refractory acute leukemia, high-risk myelodysplasia, or aggressive~     myeloproliferative disorders. Veliparib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan~     hydrochloride and carboplatin, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving veliparib together with~     topotecan hydrochloride and carboplatin may kill more cancer cells.~   "
226800|NCT00588978|"~     The purpose of this pilot study is to examine the effect of diet and/or exercise-induced~     weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin~     levels and sex steroids in obese postmenopausal women.~   "
226801|NCT00588965|"~     Background. In congenital long QT syndrome type 1 (LQT1), episodes of ventricular tachycardia~     are usually triggered by exercise and can be prevented in most patients by beta-blocker~     therapy. In addition, LQT1 associated with a normal resting QT interval can be unmasked by~     the abnormal QT response to exercise testing (failure of the QT interval to shorten~     normally). Preliminary data from our laboratory show that the exercise QT intervals of~     patients with LQT1 are partially normalized by beta-blocker therapy. It is still currently~     not known if beta-blockers modify the QT/heart rate relationship (a primary effect on~     repolarization) or if the normalizing effect is due to the inability of subjects on~     beta-blockers to attain sufficiently high workloads (due to reduced heart rate) for~     prolongation to occur. Moreover, the physiologic response of the exercise QT interval to~     beta-blockers in healthy control subjects is not known.~      Objective. The objective of this study is to define the impact of beta-blocker therapy on the~     QT response to exercise and recovery in normal subjects.~      Methods. Approximately 36 healthy adult subjects age-matched to previously studied LQT1~     subjects will undergo 1) screening history, 2) two weeks of beta-blocker therapy ending in an~     exercise test, and 3) two weeks of placebo therapy ending in an exercise test. Beta blocker~     and placebo will be given in random order in a double-blind fashion. The QT response to~     exercise and recovery will be compared between drug-free and beta-blocker-treated states.~     These data will be compared to those previously collected for LQT1 subjects.~      Implications. These results will provide new information about the effect of beta-blocker~     therapy on repolarization parameters in normal subjects, and will provide a context in which~     to interpret the previous findings that beta-blocker administration modifies the QT response~     to exercise in LQT1 subjects.~   "
226802|NCT00588952|"~     The proposed study is the first to explore the contribution of brain glutamate systems, a~     major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study~     may lead to an enhanced understanding of the underlying neurobiological mechanism in~     high-risk individuals that may lead to the transition from moderate to excessive use of~     alcohol.~   "
226803|NCT00588939|"~     Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have~     endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy~     allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this~     study is to identify the use of this new technique in diagnosing reflux in patients who have~     normal appearing esophagus.~   "
226804|NCT00588926|"~     Deep brain stimulation is commonly used for the treatment of movement disorders. Electrode~     positioning is usually performed under local anesthesia in fully awake patients. The~     procedure is uncomfortable to the patients who has to remain motionless during the whole~     surgery. Previous reports of electrode positioning under general anesthesia was found to be~     less accurate. This result was probably due to the effect of the anesthetics on the~     electrical activity of the basal ganglia.~      The purpose of this study is to detect possible changes in the electrical activity of the~     basal ganglia related to remifentanil sedation. electrical activity of single neurons will be~     recorded before, during and after sedation.~   "
226805|NCT00588913|"~     RATIONALE: Cellular adoptive immunotherapy uses a person's white blood cells that are treated~     in the laboratory to stimulate the immune system in different ways and stop tumor cells from~     growing. Aldesleukin may help the laboratory-treated white blood cells stay in the body~     longer. Drugs used in chemotherapy, such as zoledronic acid, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving cellular adoptive immunotherapy together with interleukin-2 and zoledronic acid may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving cellular adoptive~     immunotherapy together with aldesleukin and zoledronic acid and to see how well it works in~     treating patients with stage IV kidney cancer and lung metastases.~   "
226806|NCT00588900|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving irinotecan together with cediranib may kill more tumor cells.~      PURPOSE: This phase II clinical trial is studying how well giving irinotecan together with~     cediranib works in treating patients with metastatic colorectal cancer that did not respond~     to previous oxaliplatin, fluoropyrimidine, and bevacizumab.~   "
226807|NCT00588887|"~     The purpose of this study is to compare range of motion, Knee Society Scores, and duration of~     surgery for different total knee prostheses.~   "
226808|NCT00588874|"~     The purpose of this pilot study is to generate preliminary data regarding the skeletal~     effects of age-related changes in calcium and vitamin D metabolism in older men.~   "
226809|NCT00588861|"~     The purpose of this study is to document the clinical outcomes of several devices used in~     total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular~     shell, and Simplex® or Palacos® bone cement.~   "
226810|NCT00588848|"~     The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the~     regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.~   "
226811|NCT00588835|"~     The purpose of this study is to determine whether aprepitant can be used in the Cisplatin -~     Etoposide chemotherapeutic regimen.~   "
226812|NCT00588822|"~     This study was done to find out if the investigational medication, rituximab, could help~     relieve the symptoms of peripheral neuropathy (such as numbness [abnormal protein in the~     blood] and weakness of the lower and upper extremities) in people who have monoclonal~     gammopathy of undetermined significance and people with a symptomatic or smoldering~     Waldestrom macroglobulinemia.~      Rituximab is an antibody which attacks a particular type of white blood cell (B Cell). By~     targeting the B-cells which make the abnormal protein which is involved in causing the nerve~     trouble, it is hoped that damage to nerve fibers will be stopped and improvement will be~     allowed to proceed.~   "
226813|NCT00588809|"~     This phase II clinical trial is studying how well selumetinib works in treating patients with~     recurrent or refractory acute myeloid leukemia. Selumetinib may stop the growth of cancer by~     blocking some of the enzymes needed for cell growth~   "
226816|NCT00588770|"~     This randomized phase III trial studies chemotherapy to see how well it works with or without~     bevacizumab in treating patients with head and neck squamous cell carcinoma that has come~     back (recurrent) or that has spread to other parts of the body (metastatic). Drugs used in~     chemotherapy, such as docetaxel, cisplatin, carboplatin, and fluorouracil, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may~     interfere with the ability of tumor cells to grow and spread. Bevacizumab may also make tumor~     cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking~     blood flow to the tumor. It is not yet known whether combination chemotherapy is more~     effective when given with or without bevacizumab in treating patients with head and neck~     squamous cell carcinoma.~   "
226817|NCT00588757|"~     OptEase filters are easier to retrieve but the dwell time is shorter than the Gunter filters.~     There are more thrombi on the OptEase than on the Gunter at the time of retrieval. OptEase~     filter has a better infitration capabillity due to its diamond shape. OptEase filters will~     hjave more IVC occlusions as a complication.~   "
226818|NCT00588731|"~     This study is a six-week, randomized, placebo-controlled, fixed dose trial comparing~     cannabidiol Vs. placebo added to a stable dose of antipsychotic medications in patients~     diagnosed with schizophrenia.~   "
226819|NCT00588718|"~     Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the~     intestine that occurs most often in premature babies. If it progresses, the wall of the~     intestine may perforate, spilling bacteria and stool into the abdomen. Parts or all of the~     intestine may die. Despite 30 years of clinical studies, the cause of NEC remains unknown.~      In this study, we will be conducting an independent case-control validation study to verify~     the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in~     preparation for prospective validation studies, and conduct independent prospective~     validation of biosensor based biomarker panels on clinical samples.~   "
226820|NCT00588705|"~     The purpose of this study is to first understand how MSKCC Clinical Genetics Service doctors~     talk to women with breast cancer about any genetic risks they might carry, and if they help~     women to think about what they might say, in turn, to their relatives, especially their~     daughters.~      A second part of the study asks women for their opinions about when and how their daughters~     should be told about any genetic risks.~      All of this will help us develop teaching methods to help our doctors improve the way they~     talk about genetic risk when women with breast cancer have adolescent daughters.~   "
226821|NCT00588692|"~     Heart failure (HF) is the leading cause of hospitalization among Americans over the age of 65~     years, affecting greater than 5 million in the U.S. alone. Significant improvements in~     morbidity and mortality have been achieved through the use of medications that antagonize~     adverse neurohormonal signaling pathways, particularly therapies that reduce left ventricular~     (LV) afterload.~      Vascular stiffness increases with aging, contributing to the increase in cardiac load. One~     important repercussion of such stiffening is an increase in pulse wave velocity. As the~     incident pressure wave generated by cardiac ejection encounters zones of impedance mismatch~     (such as arterial bifurcations), part of the wave is reflected backward, summing with the~     incident wave, increasing central blood pressure (CBP). With normal aging, hypertension, and~     heart failure, increased wave velocity causes the reflected wave to reach the heart earlier,~     in mid to late systole, considerably increasing late-systolic load, impairing cardiac~     ejection, and diastolic relaxation in the ensuing cardiac cycle.~      The magnitude of this reflected pressure wave can be quantified by the augmentation index~     (AIx). The use of vasoactive agents which antagonize this increase in late systolic load (and~     AIx) may prove useful in the treatment of heart failure, by facilitating cardiac ejection~     during late systole when reflected pressure waves predominate. However, it has never been~     conclusively shown in humans that CBP-targeted therapy is useful in the management of HF.~      LV afterload, measured centrally in the ascending aorta, may differ considerably from~     brachial cuff-measured pressure, and has traditionally required invasive hemodynamic~     assessment to determine, limiting the applicability of techniques targeting CBP and~     late-systolic load. Recently, a novel, hand-held tonometer (SphygmoCor, Atcor Medical) has~     been developed for the noninvasive assessment of CBP. This pencil-like device is applied over~     the radial artery, and uses a validated mathematical transformation to derive central aortic~     pressure. This device has received FDA approval for clinical use in the assessment of central~     pressures. However, it remains unknown whether knowledge of CBP and late-systolic load (AIx)~     confers any clinically-significant incremental benefit in the management of patients with~     heart failure. The primary objective of the proposed investigation will be to determine if~     this assessment might have such a role.~   "
226822|NCT00588679|"~     The purpose of this study is to determine the benefits of Magnetic Resonance Imaging (MRI)~     combined with Magnetic Resonance Spectroscopic Imaging (MRSI), on an instrument called a 3.0~     Tesla (T) MR scanner.~   "
226823|NCT00588666|"~     Gemcitabine and carboplatin are two standard chemotherapy drugs used to treat tumors of the~     urothelial tract. These drugs do not shrink tumors in all patients and when they do, it is~     generally for a limited amount of time. This has led scientists to look for different ways to~     treat cancer.~      New drugs have been developed to treat cancer that work differently than standard~     chemotherapy drugs. One new class of drugs are called 'angiogenesis-inhibitors'. These drugs~     attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's~     source of oxygen and nutrients and prevent the tumor from growing. Bevacizumab is an~     anti-angiogenic drug.~      In some other cancers such as colon cancer and lung cancer, combining bevacizumab with~     standard chemotherapy shrinks tumors in a greater proportion of patients and makes patients~     live longer than using standard chemotherapy alone. This has never been tested in urothelial~     cancer and we do not know if bevacizumab will have the same effects in this disease. The~     purpose of this study is to find out what effects, good and/or bad, the combination of~     gemcitabine, carboplatin, and bevacizumab has on you and your cancer.~   "
226824|NCT00588653|"~     Prospective study to compare in a blinded fashion four different diagnostic modalities to~     detect active small bowel Crohn's disease: a) colonoscopy with ileoscopy; b) small bowel~     follow through; c) capsule endoscopy; and d) computed tomography enterography.~   "
226825|NCT00588640|"~     The purpose of this study is to determine the safest dose of d-methadone that can be given,~     without causing severe side effects in most patients with chronic pain. Patients are being~     asked to participate in the Phase I portion of this study.~   "
226826|NCT00588627|"~     This study is being done to find out why some people with mucus dripping down the back of~     their throat have a nagging cough while others do not cough.~   "
226827|NCT00588614|"~     This study is being done to find out if breast cancer detection will be improved using a~     short MRI (magnetic resonance imaging) scan, in addition to mammography, in patients who are~     at an increased risk of developing breast cancer.~   "
226882|NCT00587873|"~     The objective of this study is to determine the incidence of complete and partial response~     and the duration of response in patients with recurrent or resistant Hodgkin's disease (HD)~     treated with sequential administration of oral 6-Thioguanin (6-TG) after IV Methotrexate~     (MTX).~   "
226828|NCT00588588|"~     The reported incidence of ventilator associated pneumonia (VAP) is 10 to 15 per 1,000~     ventilator days. VAP leads to an excess cost exceeding $40,000 per patient and is associated~     with a crude mortality rate as high as 76%. The clinical criteria for the diagnosis of VAP~     have low specificity and may lead to unnecessary antibiotic use. The Clinical Pulmonary~     Infection Score (CPIS) and bronchoscopic approaches lower unnecessary antimicrobial use,~     antimicrobial resistance, and superinfection compared to the traditional clinical criteria.~      Based on the available evidence and local microbiology data, we have developed a VAP~     management protocol guided by CPIS or bronchoalveolar lavage (BAL) in adults with suspected~     VAP. These two approaches have not been compared against each other. Although the diagnostic~     studies in the CPIS guided approach are inexpensive and easily available, BAL has the~     potential to minimize the unnecessary use of antibiotics and reduce the development of drug~     resistant pathogens.~      In this study, we propose to test the hypothesis that BAL leads to a reduction in antibiotic~     use compared to CPIS in patients with suspected VAP. The study design will be a randomized,~     clinical trial comparing CPIS versus BAL. The primary outcome measure will be antibiotic~     utilization. The secondary outcome measures will be mortality, morbidity, development of~     resistant pathogens and superinfection and infection related financial burden.~      Completion of this trial will help us identify the best approach to avoid unnecessary~     antibiotic utilization and minimize the development of resistant pathogens (with their~     associated morbidity and mortality) in critically ill patients.~   "
226829|NCT00588575|"~     This study is being done to see if a new device, called near-infrared Raman spectroscopy, can~     provide similar information as that obtained from taking biopsies of the lining of your~     Barrett's esophagus~   "
226830|NCT00588562|"~     The purpose of this study is to collect medical information from a large number of patients~     in many areas of the world with primary hyperoxaluria (PH), Dent disease, Cystinuria and APRT~     deficiency. This information will create a registry that will help us to compare similarities~     and differences in patients and their symptoms. The more patients we are able to enter into~     the registry, the more we will be able to understand the Primary Hyperoxalurias,Dent disease,~     cystinuria and APRT and learn better ways of caring for patients with these diseases.~   "
226831|NCT00588549|"~     This study aims to determine whether a test, called the PET scan, may be useful in~     determining if there are additional locations of cancer not otherwise detectable by other~     tests.~      The PET scan is a nuclear medicine imaging study that measures how much radioactive sugar is~     used by your tumor. The study will compare pictures of the cancer from the PET scan to other~     x-ray exams, such as a CT scan, as well as to what your doctors find at the time of surgery.~     If the study results show that the PET scan gives us a good idea of what is happening to the~     tumor, then it may be useful in deciding which patients with colorectal metastases to the~     liver should be operated on and what operation should be performed.~      Additionally, by comparing the results of PET scans with the other studies that will be~     performed as part of your care, we will try to determine which test best tells us which~     patient is most likely to benefit from surgery.~   "
226832|NCT00588536|"~     The objective of this study is to determine the incidence of complete and partial response~     and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated~     with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).~   "
226833|NCT00588523|"~     The purpose of this study is to see how effective treatment of high doses of chemotherapy is~     for your tumor. We will also be looking at the side effects and risks of this treatment.~      You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy~     tumor cells, but it can also destroy normal bone marrow cells. These cells produce white~     blood cells (which fight infection), red blood cells (which carry oxygen) and platelets~     (which allow your blood to clot). With too few of these cells there is a serious risk of~     infection and bleeding.~      Therefore, before treatment begins, we will collect some of your own blood cells, called~     peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs~     are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs~     are thawed and given back to you. These healthy PBPCs will replace the blood cells that the~     high dose chemotherapy destroys and allow your bone marrow to recover and produce blood~     cells. In a prior study we treated 69 patients in a similar way. More than half were able to~     avoid or delay brain radiation. This new study will use a different high dose chemotherapy~     regimen.~   "
226834|NCT00588510|"~     This study focusses on finding out if osteosarcoma can be detected in blood. The cells will~     be measured by a new laboratory technique called the polymerase chain reaction. This new~     technique can identify one tumor cell among one million normal cells. Using this technique~     Memorial Sloan-Kettering Cancer Center research doctors may be able to detect tumor cells~     that could not be identified any other way. This test will be in addition to cancer treatment~     and will not replace any other test used normally. As this technique is still unproved the~     results will not be given to patients or patient's doctors and will not be used to change~     cancer treatment.~   "
226835|NCT00588497|"~     Tubal sterilization is the most prevalent form of contraception in the United States and the~     world. Currently, approximately half of these are performed with a laparoscope and half~     through a mini-laparotomy after delivery. Micro-insert hysteroscopic sterilization system~     received FDA approval for elective sterilization in 2003. Compared to other forms of female~     sterilization, this procedure is minimally invasive and does not require entering the~     abdominal cavity. In addition, it is at least as effective in preventing pregnancy as other~     forms of tubal occlusion. Given the distinct advantages of this method, it could become the~     preferred method of tubal sterilization for physicians and their patients. Currently, there~     is no published data concerning the appearance of the micro-inserts system using other~     imaging modalities that are commonly used in gynecologic practice. As the use of this device~     becomes more widespread it will be more commonly encountered in radiographic imaging~     performed as part of routine patient care. The main objective of this study is to provide~     important descriptive data concerning the ultrasonographic and x-ray appearance of the~     micro-insert hysteroscopic sterilization device. An additional objective of this study is to~     identify characteristics on plain film and ultrasound (US) that correlate with tubal~     occlusion or patency.~   "
226836|NCT00588484|"~     Develop a standard technique and demonstrate adequate precision for measurement of~     intima-media thickness (IMT) for routine clinical use.~   "
226838|NCT00588458|"~     The reason for this study is to see if a new radiologic technique called computerized~     tomographic cholangiography (CT cholangiography) could be helpful to demonstrate the bile~     ducts features and measure the amount of space of bile duct canals that should be filled with~     bile fluid. It may be useful to find out how well these findings correlate with the~     previously known clinical predictors in term of the clinical outcomes that will happen in the~     future for patients with primary sclerosing cholangitis (PSC).~   "
226839|NCT00588445|"~     The purpose of this research study is to:~        -  see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before~          surgery~        -  see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene~        -  see if patients whose tumor does shrink with gefitinib treatment are more likely to have~          a mutation in a certain part of the EGFR gene~        -  see if the pattern of protein expression in the blood is related to the tumor's~          sensitivity or resistance to gefitinib treatment.~        -  see if expression of certain genes in the tumor are related to the tumor's sensitivity~          or resistance to gefitinib treatment.~   "
226840|NCT00588432|"~     The goal of this proposal is two-fold: (1) to further develop and validate a technology,~     magnetic resonance elastography (MRE), for quantitatively imaging mechanical properties and~     tension distribution in muscle and (2) to apply the technique for in vivo evaluation of~     patients with four common, and clinically significant muscle disorders (spasticity, disuse~     atrophy, myofascial pain and a metabolic myopathy). These studies will employ a magnetic~     resonance imaging sequence with synchronous motion-sensitizing gradients to map propagating~     shear waves in the muscle. The technique will assess the mechanical properties of the muscle~     and its tension distribution. Specifically, the study can be divided into three specific~     aims. Aim 1: Optimize MRE methods of acquisition and analysis for the assessment of muscle,~     including electromechanical drivers, data acquisition techniques, and methods for image~     analysis. Advanced techniques for very rapid MRE assessment of muscle will continue to be~     developed. Aim 2: Validate the MRE assessment of muscle properties and tension with phantom,~     ex-vivo muscle, and Finite Element Modeling (FEM) techniques. Finite Element Analysis will be~     performed by using both phantom and bovine muscles to better correlate MRE wave-length~     findings as function of muscle properties, tension and fiber architecture. Aim 3: Study In~     Vivo Normal and Abnormal Muscle. The MRE technique will be applied in vivo to provide~     elastographic images of abnormal muscle with known disorders. The patient groups chosen for~     study are each important in their own right, and furnish unique information across the~     spectrum of muscular disease and dysfunction. Groups to be studied include individuals with~     new onset of spasticity following an ischemic, hemispheric stroke, disuse atrophy as a result~     of immobilization, metabolic (hyperthyroid) myopathy and myofascial pain for trigger point~     identification. The overall hypothesis of this work is that will bring benefits to both basic~     research and clinical care.~   "
226841|NCT00588419|"~     The purpose of this study is to evaluate the return of sensation in the breast(s) following~     breast mastectomy with and without reconstruction. Four different sensations: touch,~     vibration, superficial pain, and temperature will be evaluated. In addition, we will look at~     factors that may contribute to the return of breast sensations.~   "
226842|NCT00588406|"~     To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED~     patients with refractory acute asthma helps improve forced expiratory volume at one second~     (FEV1) and decrease the need for hospitalization.~   "
226843|NCT00588393|"~     This study will gather information on the safety of FolateScan and the ability of FolateScan~     to detect inflammation in the joints and other organs in people with arthritis (rheumatoid~     arthritis and osteoarthritis), systemic lupus erythematosus, multiple sclerosis, interstitial~     pneumonitis, Crohn's disease as well as in healthy persons without these conditions.~   "
226844|NCT00588380|"~     Glucagon-like Peptide-1 (GLP-1) is an important incretin hormone which acts as a powerful~     insulin secretagogue. Defects in GLP-1 synthesis and secretion are thought to be part of the~     pathogenesis of type 2 diabetes. Furthermore GLP-1 based therapy is an important part of the~     therapeutic armamentarium for the treatment of type 2 diabetes. The GLP-1 receptor (GLP1R) is~     the principal site of action of GLP-1 and GLP-1 receptor agonists like exenatide and~     liraglutide. The gene coding for this receptor, GLP1R, is highly polymorphic and contains~     numerous non-synonymous Single Nucleotide Polymorphisms (nsSNPs) which could potentially~     alter response to endogenous or exogenous GLP-1 or GLP-1R agonists. Indeed there is some in~     vitro data to support this concept. We propose to utilize a hyperglycemic clamp to test the~     insulin secretory response to infused GLP-1 in healthy volunteers to determine the effect of~     genetic variation in GLP1R on response to GLP-1.~   "
226845|NCT00588367|"~     1. Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and~          using novel post-processing techniques, is a reliable method which can be used to~          differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune~          pancreatitis.~        2. Pancreatic CT perfusion can be used to monitor patients undergoing decompression~          treatment (endoscopic retrograde cholangiopancreatography with stent placement) for~          painful chronic pancreatitis, and the change in the pancreatic perfusion parameters~          correlate with the change in the pain parameters (pain scale and analgesic use).~        3. Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at~          specific time points to replace the continuous scanning.~   "
226846|NCT00588354|"~     This was a randomized, blinded study of transforaminal epidural injection of clonidine versus~     a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was~     that clonidine will be as effective as steroid for this condition.~   "
226847|NCT00588341|"~     In this study, we want to find out how likely it is for temozolomide to shrink melanoma~     tumors that have spread only to areas that could be removed by surgery. We also want to study~     the melanoma before and after temozolomide treatment to learn why some tumors respond and~     others do not. This is a Phase II trial. This means that it will test a drug - in this case,~     temozolomide -- that has already been studied and shown to be safe.~      Surgery, when possible, is the main treatment for patients with melanoma like yours. In most~     people, however, melanoma cells have already spread to other places in the body. This means~     that even with surgery, many people will have the melanoma come back. This is often fatal.~      One goal of this trial is to treat the melanoma cells that might have spread before they have~     a chance to grow.~      As part of this trial, we also study which genes are turned on and which genes are turned off~     in your tumor. We will obtain tumor from the biopsy done before you started temozolomide~     treatment and from the tumor removed during the surgery done after you finish temozolomide~     treatment. This may help us understand how temozolomide works and how to recognize which~     tumors will respond.~      Before and during the temozolomide treatment, we will also test a new way of measuring the~     amount of tumor present. This involves a special way of analyzing the CT scan which you will~     have anyway. This new technique may allow us to see tumor shrinkage very early in the~     treatment course.~   "
226848|NCT00588328|"~     The purpose of this study is to find out whether a new device can help obtain more accurate~     CT and PET scans of the lungs and chest tumors and the liver and liver tumors to help in~     delivering radiation therapy. When we breathe, the amount of air in the lung changes. Lung~     tumors may also move during breathing. Liver tumors may also move with breathing; as the~     lungs inflate, the liver can be pushed down. A CT scan (a special type of X-ray) is routinely~     obtained as part of planning for lung or liver radiation therapy. Since patients breathe~     during this CT scan and their lung or liver tumors move, these CT scans can sometimes be~     inaccurate. We are now testing a device to only obtain the CT and an additional PET scan~     while patients are breathing in or out. This will hopefully allow us to deliver radiation~     with more accuracy.~   "
226849|NCT00588315|"~     This study investigates new non-invasive imaging techniques for the evaluation of skin~     lesions, as well as normal skin. Our primary goal is to collect and study these images of~     different skin lesions along with matching biopsy specimens. The long-term goal is to develop~     a technique that will improve the early detection of skin cancer and eliminate the need for~     many skin biopsies.~      The integrated handheld CSLM-OCT device will provide the first truly co-registered images of~     en face optical section planes (confocal) with orthogonal optical section planes (OCT).~      The imaging with a polarization-sensitive hyper-spectral dermoscope (SkinSpect) will add to~     the interpretation of CLSM images. SkinSpect will produce tissue-level functional data (i.~     e., skin chromophore maps of melanin and hemoglobin) in larger fields of view, which will be~     combined with the cellular-level detail from CLSM imaging. The combined approach will be~     tested for more accurate detection of skin morphologic characteristics.~   "
226850|NCT00588302|"~     The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different~     experimental models of chronic liver injury. We aimed to determine the safety and efficacy of~     moexipril, an angiotensin-converting enzyme (ACE) inhibitor, on liver biochemistries, Mayo~     risk score, and health-related quality of life in patients with primary biliary cirrhosis~     (PBC) who have had a suboptimal response to ursodeoxycholic acid (UDCA).~   "
226851|NCT00588289|"~     This protocol is not an independent research study, but rather a means to aggregate~     Children's Cancer Group protocols that are closed to patient entry for the purpose of~     collecting current status information on those patients treated under those protocols.~   "
226852|NCT00588276|"~     The purpose of this study is to evaluate low oxygen areas called hypoxia within the tumor.~     These low oxygen areas are thought to be the reason why tumors are more resistant to~     radiation treatment. A tracer is an extremely small quantity of a substance. Tracer to which~     radioactivity has been attached may be used to trace events in the body. A tracer called~     iodo-azomycin galactopyranoside (or *IAZGP) appears to be able to detect low oxygen areas~     within tumor.~      Radioactive iodine in this molecule can be detected by an imaging technique called a PET~     scan. This present study involves obtaining three scans using this new imaging technique. The~     goal of carrying out many scans is to determine which scan will best show any areas in your~     tumor that may have low levels of oxygen.~   "
226853|NCT00588263|"~     The intent of the proposed study is to describe the prevalence of the most common recurring~     mutations in BRCA1 and BRCA2, blmAsh , and the A636P MSH2 mutation among Ashkenazi Jewish~     individuals with a variety of cancer diagnoses. If a substantial proportion of these samples~     contain such mutations, future patients presenting with these diseases may wish to undergo~     genetic counseling and, if appropriate, formal genetic testing. The benefit from such a~     process would pertain mainly to the families of these individuals.~   "
226854|NCT00588250|"~     Hypothesis: a special solution for improving human embryo implantation, when added to the~     solution during embryo transfer, will improve implantation rates in embryo transfers using~     previously frozen embryos.~   "
226855|NCT00588237|"~     The purpose of this study is to test whether it is safe to treat your cancer with 3 drugs~     instead of 2 drugs. After surgery, your cancer is typically treated with 2 drugs called~     cisplatin and paclitaxel (also known as Taxol). Cisplatin is given through a port in your~     belly, and Taxol is given both through the belly port and through the vein (IV). Large~     clinical studies have shown that this treatment gives the best results for women with your~     cancer. This treatment, however, also causes many side effects, especially belly pain, nerve~     injury, lowering of the immune system, and infection risk. In the study you are being asked~     to join, the dose of Cisplatin will be lower in order to try to lessen these problems. This~     study will also test the safety of adding a 3rd drug called bevacizumab (also known as~     Avastin). This drug has been shown to shrink ovarian, peritoneal, or fallopian tube cancer in~     some patients who have advanced disease, despite having received prior treatment for their~     cancer. Therefore, it may also be effective in patients, like you, who have a new diagnosis.~      Unfortunately, Avastin can cause some dangerous side effects in women with advanced cancer.~     For instance, it can cause a hole in the intestines, and can increase the risk of blood clots~     and strokes. Avastin has not been given at the same time as IP therapy, so it is not known if~     this is a safe or effective combination. In this study, IV Avastin will be given in addition~     to IP cisplatin, IP Taxol, and IV Taxol, to patients like you who have not had any~     chemotherapy before. This study aims to find out what effects, good and/or bad, that this~     combination of drugs has on your body and on your type of cancer.~   "
226856|NCT00588224|"~     The goal is to study the accuracy of 3-dimensional ultrasound (which does not involve~     radiation) to measure the size of the stomach, comparing it with a previously validated~     method that involves radiation. This will make it possible to check the stomach function of~     children without exposing them to radiation. A second goal is to measure the size of the~     stomach and the effect of a standard meal on stomach volume in adolescent boys and girls.~   "
226857|NCT00588211|"~     The purpose of this study is to develop an accurate way of measuring people's thoughts about~     cancer risk. The researchers at the Queens Hospital Center, Memorial Sloan-Kettering Cancer~     Center and Adelphi University are working together to design a new measure. Findings from~     this study will help us find new ways to help people avoid cancer.~   "
226858|NCT00588198|"~     The purpose of this study is to determine if tumor cells can be detected in the peripheral~     blood and/or bone marrow of patients with melanoma.~   "
226859|NCT00588185|"~     This study will use PET scans, which is a type of x-ray test that uses a radiotracer, to see~     whether these scans may be better able to find places in the body where your prostate cancer~     may have spread.~   "
226860|NCT00588172|"~     Type 2 diabetes its microvascular and macrovascular complications have become a major global~     health problem. Metformin is often used as first-line therapy for this disorder given that it~     is cheap, may cause weight loss and does not have significant side-effects in healthy~     patients. On the other hand, as many as one third of all patients with type 2 diabetes~     initially treated with metformin never achieve a meaningful response to this intervention.~     Recently, genetic variation in the organic cation transporter 1 (Oct1) gene which encodes a~     protein, OCT1, mediating metformin uptake by the liver, its primary site of action, has been~     shown alter metformin action. In Oct1-deficient mice the glucose-lowering effects of~     metformin are completely abolished. Moreover a polymorphism with a 20% minor allele frequency~     in Caucasians also alters the effect of metformin on glucose tolerance (the net result of~     glucose uptake and glucose release) after ingestion of 75g of glucose. However, it is unknown~     if this polymorphism affects suppression of endogenous glucose production or stimulation of~     peripheral glucose uptake by metformin, or both, and to what degree. We propose to utilize~     established methodology to measure glucose turnover in response to a mixed meal to determine~     how common genetic variation in OCT1 alters response to metformin in healthy volunteers. This~     will clarify the effect of these variants on response to metformin in humans. The knowledge~     gained from this study will help to design future studies examining the role of OCT1 genotype~     in determining initial therapy for type 2 diabetes.~   "
226861|NCT00588159|"~     One dose of either gabapentin or placebo will be given to patients prior to thoracotomy.~     Patients will also receive an epidural infusion, intravenous patient-controlled analgesia~     with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal~     analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and~     will also be assessed at 3 months postoperatively to determine whether the patients who~     received gabapentin had improved analgesia and/or required less supplemental medication than~     the placebo group.~   "
226862|NCT00588146|"~     The purpose of the study is to evaluate the safety and tolerability of pegylated interferon~     alpha-2b (PEG-Intron) in patients with severe complications related to Hereditary hemorrhagic~     telangiectasia (HHT).~      Funding Source - FDA Office of Orphan Products Development (OOPD)~   "
226863|NCT00588133|"~     Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac~     surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have~     developed an alternative dosing schedule for tranexamic acid. The objective of this~     preliminary study is to determine if this new dosing schedule can achieve the desired plasma~     concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic~     acid plasma concentrations relative to the current dosing schedule.~   "
226864|NCT00588120|"~     The purpose of this study is to learn more about a condition called 'unclassified~     hyperoxaluria'. People with this condition have large amounts of oxalate in their urine,~     which can cause kidney stones and kidney failure. We do not know what causes the high level~     of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate~     taken orally by measuring the amount of the test dose that is eliminated in the urine. We~     will compare the results of affected patients to healthy volunteers.~   "
226865|NCT00588107|"~     The purpose of this study was to compare two different ways of helping people who have had~     childhood cancer, leukemia, tumors or similar illnesses learn health information and~     information about trying to quit smoking. All participants received materials in the mail~     about their health, survivorship, and smoking. Some participants were also invited to use a~     website. The goal of the study was to see which is a better way to get information about~     health issues, survivorship, and smoking.~   "
226866|NCT00588094|"~     The purpose of this research is to study a treatment program for patients with aggressive~     lymphoma that has come back after initial or first therapy (called relapsed) or that has not~     responded to first therapy (called refractory). Since 1993, we have used a combination of~     chemotherapy known as ICE (Ifosfamide, Carboplatin, and Etoposide) for your type of lymphoma.~     In many patients, this treatment helps the disease to shrink before giving high-dose therapy~     and autologous stem cell transplant (ASCT). Only patients who respond to these types of~     treatments have a chance of their disease going away (remission) with an ASCT. In 1999, we~     studied the same treatment but added another medicine for your type of lymphoma, Rituximab~     (Rituxan), to the ICE treatment (RICE). More patients had lymphoma shrinkage from this~     treatment (chemosensitive disease) than with ICE alone. These patients then received high~     dose therapy and autologous stem cell transplant and have an improved chance of having a~     remission.~      ICE chemotherapy is standard chemotherapy used at Memorial Sloan-Kettering Cancer Center.~     However, it is different in this study because of the higher doses. We are testing higher~     doses of RICE treatment for patients in this study.~      In our current study in Hodgkin's lymphoma, we are giving these higher doses of ICE (called~     augmented ICE) to patients who also have higher risk. We hope to show in this study that by~     using Rituximab and augmented ICE that we can improve your ability to achieve a remission~     (that is, to have the disease go away).~   "
226867|NCT00588081|"~     This study is being done to find out more about the experience women have with vaginal~     reconstruction. We hope to learn about their quality of life, sexual function, and body~     image. We would like to find out how happy women are with surgery. We also want to know what~     things should be changed or improved. Since you have had this surgery, we would like to ask~     you to take part in an interview.~   "
226868|NCT00588068|"~     The purpose of this study is to find out the genetic and biochemical makeup of your~     neuroblastic tumor, which influences its aggressiveness and the suitable therapy. These~     research studies include surface marker analysis, cytogenetics, cancer genes,genome~     sequencing, tumor growth-related genes and tumor growth in test tubes. Your blood, marrow,~     and hematopoietic stem cell samples will also be tested for tumors or leukemia cells, and~     your serum tested for anti-tumor antibodies.~   "
226869|NCT00588042|"~     Ischemic preconditioning (IP) has been shown in animal studies to increase the myocardial~     tolerance to subsequent ischemia. Our primary hypothesis is that remote IP reduces myocardial~     ischemic injury during PCI.~   "
226870|NCT00588029|"~     The purpose of this study is to collect a blood sample from patients with breast disease~     (cases) and from individuals without breast cancer (controls)that may be used for research~     purposes. These blood samples will be used by researchers at Memorial Sloan-Kettering Cancer~     Center who study the causes of breast cancer, as well as more effective ways to prevent,~     diagnose, and treat breast cancer.~   "
226871|NCT00588016|"~     The primary objective of this study is to determine the concentration of itraconazole~     irrigation in nasal mucous specimens via collection and High-performance liquid~     chromatography (HPLC) assay.~      Eight (8) patients with chronic rhinosinusitis (CRS) and two (2) healthy controls will be~     enrolled in the initial evaluation. After an initial control nasal specimen, followed by~     seven days of twice daily topical itraconazole irrigation, nasal specimens will be collected~     at varying time intervals and the concentrations measured.~      The primary endpoint is development of a reliable collection and assay technique with~     concentration curves over time of topically administered itraconazole. A secondary endpoint~     is to determine if the concentrations measured achieve a mean inhibitory concentration~     (MIC90) to commonly cultured fungal species in the nose.~   "
226872|NCT00588003|"~     The purpose of this pilot study is to see if taking anastrozole (Arimidex) for 10 days causes~     changes in breast cancer cells. Anastrozole (Arimidex) is a drug used in the treatment of a~     type of breast cancer that depends on estrogen to grow. This type of breast cancer is called~     estrogen receptor positive breast cancer. Anastrozole (Arimidex) works by blocking an enzyme~     in your body called aromatase. Aromatase is found in your muscles, fat, liver and in breast~     tumors. This enzyme is important for making estrogen in women who are no longer having~     menstrual periods. Anastrozole decreases levels of estrogen in the body. We are interested in~     seeing if taking anastrozole for 10 days will cause changes in breast cancer cells. We will~     study cell processes such as how they make new blood vessels, how quickly the cells multiply,~     and how soon they die. We will also study which genes in the breast cancer tissues are turned~     on or off by taking anastrozole for 10 days.~   "
226873|NCT00587990|"~     Heart attacks are a leading cause of death in both men and women in the United States. When a~     person has a heart attack, blood is unable to reach a certain area of the heart, and if the~     blood supply is not re-established quickly, that area of the heart can suffer permanent~     damage. While recovery from a heart attack can be managed through medications and lifestyle~     changes, these treatments can not reverse the original damage to the heart. Current research~     is focusing on the development of cell-based therapies using stem cells to repair organs that~     have been irreversibly damaged by disease. A specific form of stem cells, called adult~     mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate~     the safety and effectiveness of injecting MSCs into the heart to repair and restore heart~     function in people who have had a heart attack and who are having heart surgery for coronary~     artery bypass grafting (CABG).~   "
226874|NCT00587977|"~     Can software be developed to automatically aid in the measurement of abdominal aortic~     aneurysms, and is there a way to predict future rupture or growth of abdominal aortic~     aneurysms.~   "
226875|NCT00587964|"~     For patients who have one or two metastases in the brain, the tumor(s) can often be removed~     with surgery to relieve symptoms from the tumor(s) and to improve survival. However, about~     half of all patients who have the tumor(s) removed with surgery will develop regrowth~     (recurrence) of the tumor. To prevent this regrowth of tumor, some patients receive radiation~     to the entire brain (whole brain radiation) after surgery. This involves daily treatment for~     about two to three weeks, and may cause long-term neurological problems, such as memory loss.~      Stereotactic radiosurgery (SRS) is sometimes used instead of surgery to treat brain~     metastasis. This involves the use of a special head frame and sophisticated computer programs~     that enable us to deliver a high dose of radiation to a small focused area of the brain in~     only one treatment.~      Research has shown that the results of treatment with SRS are as good as surgical removal of~     the tumor. SRS and surgical resection are considered the standard options for the treatment~     of brain metastases. This Phase II clinical trial is studying the combination of these two~     techniques. The purpose of this study is to evaluate the use of SRS following surgical~     removal of brain metastases. The outcomes we will be looking at are tumor regrowth after~     treatment and side effects of treatment.~   "
226876|NCT00587951|"~     The aim of this study is to determine the role of SISCOM (see below) in aiding clinicians to~     manage epilepsy surgery candidates. SISCOM is already a routine component of pre-surgical~     epilepsy evaluation at Mayo Clinic. In particular, we are interested in assessing whether use~     of SISCOM can minimize the need for prolonged (>24 hours) invasive monitoring with electrodes~     placed on the surface of the brain prior to surgical resection.~      Note: this study has recruited the required number of patients and is closed to further~     enrolment.~   "
226877|NCT00587938|"~     Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic~     accuracy for congestive heart failure (CHF). Limited information is available regarding~     economic outcomes attributable to BNP assay. The aim of this study was to assess the economic~     impact of BNP assay in elderly dyspneic patients presenting to the emergency department (ED).~   "
226878|NCT00587925|"~     Bone Mineral Density (BMD) as measured by X-ray shows the amount of calcium in the bone. Low~     BMD may reflect osteoporosis, a condition where there is an increased risk of fracture. Women~     who have gone through menopause have a higher risk of getting osteoporosis because they lose~     calcium from their bones much faster than younger women. Women with breast cancer may have an~     additional risk for getting osteoporosis because of the effects of their treatment with~     chemotherapy. The purpose of this study is to see what levels of BMD post-menopausal women~     with breast cancer have, and to see if the level of BMD changes during a women's treatment~     after her surgery. This trial studies changes in BMD and markers of bone activity in women~     receiving treatment for early stage breast cancer.~   "
226879|NCT00587912|"~     The purpose of this study is to obtain clinical specimens from pathologists and physicians~     involved in the diagnosis and care of patients with AIDS and non-AIDS associated~     malignancies.~      The National Cancer Institute has set up a Bank for tissues and biological fluids from~     HIVpositive and HIV-negative individuals in order to have specimens available for scientists~     studying malignancies associated with HIV disease.~   "
226880|NCT00587899|"~     This study is being done to learn the effects of the Pulmonary Vein Isolation in patients~     that are at high risk to developing, but do not have a documented history of atrial~     fibrillation.~   "
226881|NCT00587886|"~     The purpose of this study is to see how people's diets, other aspects of their lifestyles,~     and their individual genetic makeup affect their chances of getting endometrial cancer~     (cancer of the uterus).~      This survey will enroll several hundred women who have or have had endometrial cancer and~     several hundred who do not. We will compare these two groups of women to see what factors may~     lead to endometrial cancer.~   "
226883|NCT00587860|"~     This study is being done to see if St. John's wort helps people with irritable bowel~     syndrome, otherwise known as IBS. St. John's wort is a herbal supplement derived from the~     St. John's wort plant. It has been shown to be helpful in several medical conditions such as~     depression as well as other pain syndromes.~   "
226884|NCT00587847|"~     This is a study designed to test whether giving campath (also known as alemtuzumab) on a~     maintenance schedule will prolong the time until the patient requires chemotherapy.~   "
226885|NCT00587834|"~     The purpose of this study is to evaluate Gintuit as a safe and effective alternative to~     palatal tissue in the treatment of subjects (with recession-type defects) who have an~     insufficient zone of attached gingiva associated with at least two nonadjacent teeth.~   "
226886|NCT00587821|"~     This study is being done to learn about blood proteins. We want to see if the blood proteins~     in women whose biopsies show breast cancer are different from the blood proteins in women~     whose biopsies do not show breast cancer. The goal of this study is to develop a blood test~     than can help detect breast cancers when they are very small and easy to cure.~   "
226887|NCT00587808|"~     The guiding hypotheses are that (1) mechanisms in addition to diastolic dysfunction, while~     normal at rest, are compromised with stress, leading to symptoms of HF, and (2) that an~     increased proportion of the increase in LV diastolic pressures seen in HFpEF is mediated via~     exaggerated pericardial/right heart-LV coupling (restraint).~   "
226888|NCT00587795|"~     Objectives:~      - To obtain clinical evidence for the safety and efficacy in using the StabilAir Wrist~     Fracture Brace for the following cases:~        1. Acute (emergency department) treatment of non-displaced, stable extra- articular distal~          radius fractures;~        2. To obtain comparative data between traditional therapies (sugar tong, plaster backslab,~          long arm or short arm cast) and the use of the StabilAir brace for each patient~          qualified by specific criteria.~      Hypothesis:~      1) For stable, non-displaced fractures, the StabilAir Brace is as effective as a sugar tong~     splint in the acute setting. 2) In cases where full forearm immobilization is initially~     preferred, the StabilAir is effective as a follow-up to sugar tong splitting once the need~     for full immobilization has passed.~   "
226889|NCT00587769|"~     The overarching goal of this line of research is to increase smoking abstinence rates using a~     combination of existing pharmacotherapies. The aim of the current study is to assess the~     safety and compliance as well as obtain preliminary estimates of efficacy and effect on~     craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We~     will compare the efficacy estimates in this study with historical smoking abstinence rates~     with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an~     open-label, phase II clinical trial.~   "
226890|NCT00587756|"~     Two-stage hepatectomy with or without portal vein embolization allows to treat multiple~     bilobar metastases expanding surgical indications for these patients. However, it has some~     related drawbacks: two operations are needed, and some patients do not complete the treatment~     strategy for disease progression. Using experience gained from our ultrasound guided~     resection policy we explored the safety and effectiveness of one-stage surgical procedures in~     patients otherwise recommended for the two-stage approach.~   "
226891|NCT00587730|"~     The accuracy of stress single photon emission computed tomography (SPECT) is limited by~     imaging artifacts, many of which are caused by soft tissue attenuation. A recent multicenter~     study performed by our laboratory comparing 7 commercially available attenuation correction~     (AC) camera systems in a cardiac phantom showed the best performance with the GE Hawkeye (a~     hybrid gamma camera-CT scanner) and the University of Michigan M-step (unique feature a~     camera orbit of 360˚ versus the usual 180˚) systems. In this study we will combine the~     strengths of these two systems (GE Hawkeye AC system and 360˚ camera orbit) to test the~     accuracy of this imaging system in a population of 400 consecutive patients undergoing~     clinically indicated stress SPECT. These patients will undergo SPECT imaging both with~     conventional methodology and the GE Hawkeye system. The conventional study will be~     interpreted and reported in the usual clinical fashion. The GE Hawkeye images will be~     interpreted independently by 2 observers blinded to the results of conventional imaging and~     will not be reported clinically. The primary study hypothesis is that AC will substantially~     reduce attenuation artifacts (mild fixed defects) without reducing the accuracy of either~     normal studies or myocardial infarction (MI). Clinical data and noninvasive test results~     (history of MI, electrocardiogram, and gated wall motion) will be used to distinguish defects~     which represent attenuation (false-positive) versus those due to MI (true-positive).~   "
226892|NCT00587717|"~     This study is being done to determine if the acute administration of the drug Simvastatin~     reduces plaque tissue inflammation and plaque instability in patients undergoing carotid~     endarectomy~   "
226893|NCT00587704|"~     Primary aim:~      1. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1~     in providing surgical anesthesia for patients undergoing inguinal hernia repair.~      Secondary aims:~        1. Compare VAS pain scores in the two groups of patients over the first 24 hours.~        2. Compare opioid intake over the first 24 hours in the two groups of patients.~   "
226894|NCT00587691|"~     The purpose of the study is 1) to study the safety and tolerability of escalating doses of~     myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of~     T Cell Vaccine ion the clinical course of MS.~   "
226895|NCT00587678|"~     The purpose of this study is to develop new ways of imaging fatty blockages in the leg~     arteries to improve upon techniques used now and to develop new ways of understanding how new~     treatments may affect the disease.~   "
226896|NCT00587665|"~     Comparing patients receiving subanesthetic doses of Ketamine vs placebo to see if it can~     reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy~   "
226897|NCT00587652|"~     This study is being done to:~      Determine if a temporary dye applied to the esophagus identifies areas of dysplasia~     (pre-cancer). Determine if certain dye patterns indicate specific grades of dysplasia.~     Determine if overall endoscopy costs can be reduced with this dye technique. Determine if the~     dye could allow fewer biopsies to be obtained in the future.~   "
226898|NCT00587639|"~     The objective of this investigation is to examine the safety and feasibility of a series of~     repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz [Hz]; Left~     Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant~     treatment for depression in adolescent subjects.~   "
226899|NCT00587626|"~     The purpose of the proposed study is to evaluate the efficacy of the InterX 5000 in relieving~     chronic neck and shoulder pain. This study will focus on the efficacy of treating patients~     who have functional limitations in activity because of chronic/recurrent neck or shoulder~     pain.~      H1: InterX therapy will have a moderate effect to reduce pain.~      H2: Functional gains will be greater in patients receiving InterX therapy compared to those~     who received placebo treatment.~      H3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic~     evidence of degenerative spondylosis/arthrosis of the cervical spine.~   "
226900|NCT00587600|"~     This study is being done to find out if Photodynamic Therapy (treatment with a red light and~     a drug called photofrin) or Radiofrequency ablation works the same for patients who have~     biomarkers (abnormalities in molecules of cells that may or may not help predict cancer)~     present in their Barrett's esophagus as for patients who do not have biomarkers.~   "
226901|NCT00587587|"~     This pilot study will assess the safety and efficacy of Apligraf in the healing and~     recurrence of keloids post surgical shave excision in patients with clinically diagnosed~     keloids.~   "
226902|NCT00587574|"~     Allogeneic hematopoietic cell transplantation offers high cure rates for patients with~     hematological and oncological diseases. Graft-versus-host disease (attack of donor's white~     blood cells on patient's tissues) is a serious complication also affecting the patient's~     immune system. Therefore, patients in the early phase after allogeneic cell transplantation~     are at high risk for severe infectious complications. So far, no predictive biomarkers for~     the development of the chronic form of graft-versus-host disease are available. By analysing~     serially immune cell populations of the peripheral blood we will investigate whether certain~     subsets of cells are associated with development of chronic graft-versus-host disease. In~     addition, the patients' immune regeneration will be evaluated by serial analyses of~     peripheral blood immune cell populations 3 months to 2 years after allogeneic cell~     transplantation.~   "
226903|NCT00587561|"~     The term social cognition refers to how social information is processed. Individuals with~     schizophrenia and schizoaffective disorder have been shown to have significant deficits in~     social cognition. Moreover, it has been speculated that these deficits may in turn have a~     negative impact on their overall functioning. Behavioral interventions targeting social~     cognition are just beginning to emerge, and there is a need to evaluate their efficacy.~      Objectives:~      This is a small trial evaluating the efficacy of social cognition interaction training (SCIT)~     an experimental behavioral treatment for improving social cognition in schizophrenia.~      Research Design and Methodology:~      Approximately 48 participants with schizophrenia-spectrum disorders will be randomized into~     one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training~     group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms,~     social cognition, basic cognition, and community function will be conducted. Data obtained~     from this study will allow us to determine the efficacy of SCIT training in improving~     symptom, cognitive, and functional measures.~   "
226904|NCT00587548|"~     This study is being done to find a different way to identify the ureters during an abdominal~     operation.~      During some operations, the operating physician must identify where the ureters are to~     prevent injury to them. Typically, the surgeon calls the urologist to thread a small scope~     with a camera into the urethra (where the urine comes out) to place a wire into each of the~     two ureters to locate them. Instead of this procedure, we will inject a small amount of a~     radioactive chemical dye (TC99-DTPA)through a vein in your arm. The ureters can then be~     detected by a hand held probe called the 'gamma probe.' The TC99-DTPA dye passes through the~     body and is excreted through the urine. The goal of this study is that this probe will alert~     the physician when it placed directly over the ureters since the TC99-DTPA dye will highlight~     the ureters as the flow of urine goes through them.~   "
226905|NCT00587535|"~     The purpose of this study is to determine if a new MR pulse sequence is accurate in~     determining how much iron is in the liver.~   "
226906|NCT00587522|"~     The purpose of this prospective, multicenter study was to evaluate the safety and efficacy of~     endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux.~      Sixty-four patients were enrolled and underwent endoscopic full-thickness plication. All~     patients received a single implant/plication. No repeat plication procedures were performed.~      Primary efficacy in this study was measured by the percent reduction in post-procedure GERD~     symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life)~     questionnaire. Secondary efficacy outcomes included post-procedure reduction in~     anti-secretory therapy, improvement in quality of life questionnaires, reduction in distal~     esophageal acid exposure, and improvement in esophageal manometry. Patient follow-up~     assessments were completed at 1, 3, 6 and 12 months post treatment.~   "
226907|NCT00587496|"~     The purpose of this study is to determine whether oral Valtrex alone or in combination with~     aspirin will reduce the shedding of herpes simplex virus DNA in the tears and saliva from~     volunteers with no evidence of ocular herpes infection. The secretion of virus into the tears~     and saliva might make people more susceptible to virus infection in the future if their~     immune system becomes deficient. The study will also try to determine if there is a~     correlation between shedding of viral DNA and herpes virus antibodies in serum and to~     determine if subjects are carriers of a special form of a gene in their blood cells, the~     presence of which may suggest the possibility of an increased susceptability to herpes and to~     Alzheimer's disease and heart disease.~   "
226908|NCT00587483|"~     This was a prospective, randomized, double blinded study in which patients undergoing a~     cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive~     amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB is~     a technique that temporarily takes over the function of the heart and lungs during surgery,~     maintaining the circulation of blood and the oxygen content of the body.) Specifically, we~     will test the hypothesis that amiodarone is superior to both lidocaine and placebo in the~     prevention of a severely abnormal heart rhythm when the blood flow is restored to the heart~     after the aortic cross clamp is removed.~   "
226971|NCT00586638|"~     Control processes are classes of brain activity that initiate, coordinate, synchronize, and~     regulate elemental cognitive functions for the conduct of goal-directed behavior. The~     proposed research investigates whether exposure to a computer-based training protocol~     designed to enhance cognitive control processes will improve cognitive performance in healthy~     older adults.~   "
226909|NCT00587470|"~     Mitral regurgitation (MR) is common in the elderly and its prevalence is increasing with the~     aging of the population. Organic MR, due to primary valvular lesions, initiates a cascade of~     complications determined by its degree. MR of severe degree is associated with excess~     mortality and high cardiac morbidity (heart failure, atrial fibrillation). It also causes~     left ventricular remodeling which induces left ventricular dysfunction, which in turn leads~     to poor clinical outcome. Surgery can eliminate MR, but carries immediate and long-term~     risks, especially in the elderly. Therefore, chronically decreasing the degree of MR is a~     major goal of medical therapy but such an effect is yet unproved because of conflicting~     results of small and mostly non-randomized series. Our recent preliminary studies suggest~     that a sustained decrease of degree of MR and improvement of left ventricular remodeling can~     be achieved with powerful reduction of afterload, obtained in particular with angiotensin-II~     receptor blockade. Therefore, the present proposal seeks to address gaps of knowledge~     regarding vasoactive treatment of MR through the verification of the following hypothesis:~     Hypothesis: Vasoactive therapy using angiotensin-II receptor blocker (Candesartan Cilexetil)~     weighed against placebo produces a sustained reduction of the consequences of organic MR. The~     specific aims are that the treatment a) decreases the degree of MR (decreases the regurgitant~     volume, primary end-point) and b) improves left ventricular remodeling (decreases the~     end-diastolic volume index, secondary end-point), as compared to placebo.~   "
226910|NCT00587457|"~     This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety~     and anti-neoplastic activity of moxetumomab pasudotox in relapsed or refractory participants~     with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or Small Lymphocytic~     Lymphoma (SLL).~   "
226911|NCT00587444|"~     Study has been completed and is in the data analysis and manuscript writing phase of the~     project.~   "
226912|NCT00587431|"~     We postulate that multiple apoptototic events are indusce through testosterone depletion and~     repletion with taxotere given in conjunction with androgen withdrawal.~   "
226913|NCT00587418|"~     Chronic renal insufficiency is a common and important health problem that causes morbidity~     and mortality among patients who have undergone liver transplantation. It is mainly caused by~     drugs (calcineurin inhibitors) that are used to prevent or treat rejection and once~     established, there is no effective treatment. This research investigates whether L-arginine~     can reverse the effects of calcineurin inhibitors on the kidneys and thus prevent renal~     insufficiency in liver transplant recipients.~   "
226914|NCT00587405|"~     To see if either method of treatment for Watermelon Stomach shows better results~   "
226915|NCT00587392|"~     The purpose of this study was to gather long-term follow-up data on patients treated with the~     Plicator in a previous open-label multi-center study. Originally, 64 subjects were treated at~     seven U.S. sites. A subset of those patients were subsequently reassessed via symptom~     questionnaires in this long-term (60-month) follow-up analysis. The initial open-label study~     was completed and officially closed at the completion of 1-year follow-up. This current study~     was designed to collect long-term follow-up data on previously plicated subjects all of whom~     were recruited de novo from the original study population. Study endpoints were prospectively~     defined. The primary study objectives were to assess: reduction in GERD symptoms through~     analysis of the GERD Health Related Quality of Life (HRQL) questionnaire and the~     Gastrointestinal Symptom Rating Scale (GSRS); reduction in use of GERD medications, and~     change in overall physical and psychological health as measured by the Short Form Health~     Survey (SF-36).~   "
226916|NCT00587379|"~     To determine if 6 weeks of daily treatment with Atorvastatin 40 mg alters the immediate~     effect of Sildenafil Citrate (Viagra, Pfizer Inc, New York, NY) on endothelial function~     (activity of the artery) as measured by noninvasive peripheral arterial tonography in men and~     women. Also, to determine if 6 weeks of daily treatment with Atorvastatin 40 mg affects~     erectile function in men~   "
226917|NCT00587353|"~     Tobacco prevention and intervention strategies in the general population are ongoing and~     evolving. However, strategies to help cancer patients overcome tobacco dependence have been~     limited. Radiation oncology patients who continue to smoke despite their cancer diagnosis~     have a lower quality of life (QOL), increased frequency and severity of side effects during~     their cancer treatment, higher risks of developing a smoking-related primary cancer, and may~     have a poorer survival rate than their non-smoking counterparts. These are all compelling~     reasons to be more pro-active in helping cancer patients stop smoking. The overall objective~     of this project is to adapt a model of an effective tobacco use intervention that can be~     delivered by any trained radiation oncologist and their staff.~   "
226918|NCT00587340|"~     The purpose of this study is to gain greater understanding of the problems breast cancer~     survivors experience related to difficulty sleeping and insomnia. Poor sleep can affect a~     person's mood, increase feelings of fatigue, as well as pain. A greater knowledge and~     understanding of sleep disturbances can lead to more effective treatment of sleep problems~     and significantly improve quality of life.~   "
226919|NCT00587327|"~     The main purpose of this clinical research trial was to evaluate the effects of barusiban and~     atosiban compared to placebo on luteal phase uterine contractions in oocyte donors~     supplemented with progesterone.~   "
226920|NCT00587314|"~     To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation )~     on Barrett's Esophagus~   "
226921|NCT00587301|"~     This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in~     the morbidly obese adolescent population.~   "
226922|NCT00587288|"~     The purpose of this study is to determine the effectiveness and safety of reslizumab in the~     treatment of subjects with poorly controlled asthma.~   "
226923|NCT00587275|"~     The purpose of this project is to test how safe and how well AST-120, an investigational~     product, works in treating too much acid in the stomach. Patients will be randomly assigned~     to one of two groups, AST-120 or a placebo for the first four weeks of the study. The~     patients will be switched to the other group (AST-120 or placebo)for the following four~     weeks.~   "
226924|NCT00587262|"~     Insertion of electrode array in scala vestibuli, rather than the preferred location within~     scala tympani, leads to loss of native hearing in those patients with isolated high-frequency~     hearing loss undergoing cochlear implantation.~   "
226972|NCT00586625|"~     Safety study for bepotastine besilate ophthalmic solution in normal volunteers~   "
226925|NCT00587249|"~     The purposes of this study are to evaluate the safety and immune responses (the body's~     defense system) to an investigational malaria vaccine called ICC-1132. Three different doses~     of the vaccine will be studied in 3 groups of people, and the results will be compared. The~     study will involve about 80 healthy volunteers, 18-45 years of age, who will receive an~     injection of a specific dose of the vaccine in their arm on 2 or 3 different days. Blood~     samples will be collected approximately 15 times for laboratory studies. Volunteers will~     record their temperature twice per day. Volunteers will complete a daily symptom diary for 7~     days after each vaccination. Volunteers will participate in the study for up to 13 months.~   "
226926|NCT00587236|"~     This study is being done to:~      To attempt to increase the detection of precancerous colon tissue in patients with chronic~     ulcerative colitis and primary sclerosing cholangitis;~      To determine if an investigational scope that can look at the lining of the colon in~     different ways will help the doctor identify abnormal tissue in patients with chronic~     ulcerative colitis and concurrent primary sclerosing cholangitis; and~      To determine if this investigational scope can accurately detect precancerous or cancerous~     tissue in patients with chronic ulcerative colitis that are known to have had cancerous or~     precancerous tissue in the past.~   "
226927|NCT00587223|"~     The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing~     wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be~     evaluated for efficacy and safety compared to a conventional nonadherent dressing. A~     matched-pair design will be used to evaluate Apligraf treatment versus conventional treatment~     in 68 study pairs.~   "
226928|NCT00587210|"~     The purpose of this study is to assess the exam quality and accuracy of MR using a new oral~     contrast agent for the evaluation of Crohn Disease in the small bowel.~   "
226929|NCT00587197|"~     Patients with cirrhosis require endoscopic screening for large esophageal varices. The aims~     of this study were to determine the cost -effectiveness and patient preferences of a strategy~     employing abdominal computerized tomography (CT) as the initial screening test for~     identifying large esophageal varices. In a prospective evaluation,102 patients underwent both~     CT and endoscopic screening for gastroesophageal varices. Two radiologists read each CT~     independently; standard upper gastrointestinal endoscopy was the reference standard.~     Agreement between radiologists, and between endoscopists regarding size of varices was~     determined using kappa statistic. Cost-effectiveness analysis was performed to determine the~     optimal screening strategy for varices. Patient preference was assessed by questionnaire. CT~     was found to have an approximately 90% sensitivity in the identification of esophageal~     varices determined to be large on endoscopy, but only about 50% specificity. The sensitivity~     of CT in detecting gastric varices was 87%. In addition, a significant additional number of~     gastric varices, peri-esophageal varices, and extraluminal pathology were identified by CT~     but not identified by endoscopy. Patients overwhelmingly preferred CT over endoscopy .~     Agreement between radiologists was good regarding the size of varices (Kappa = 0.56), and~     exceeded agreement between endoscopists (Kappa = 0.36). Use of CT as the initial screening~     modality for the detection of varices was significantly more cost-effective compared to~     endoscopy irrespective of the prevalence of large varices. In conclusion, abdominal CT as the~     initial screening test for varices could be cost-effective. CT also permits evaluation of~     extra-luminal pathology that impacts management.~   "
226930|NCT00587184|"~     This data review will be done to evaluate the use of confocal microscopy imaging in patients~     who were seen for clinically indicated endoscopic surveillance and biopsies of Barretts~     Esophagus~   "
226931|NCT00587171|"~     This study is comparing the effectiveness of patching combined with active vision therapy~     plus near activities versus patching combined with control vision therapy plus near~     activities for moderate amblyopia (20/40-20/100) in 7 to <13 year olds.~      The primary outcome measure is the proportion of patients with visual acuity of 20/25 or~     better in the amblyopic eye at the 17-week masked exam. These patients will be considered~     treatment responders. The primary analysis will consist of a comparison between the 2~     treatment groups of the proportion of treatment responders with adjustment for baseline~     visual acuity.~      Secondary outcomes are stereoacuity at the 17-week masked exam, mean improvement in visual~     acuity at the 17-week masked exam, and rate of improvement of visual acuity.~   "
226932|NCT00587158|"~     This study is being done to find out whether patients who receive a kidney transplant can~     benefit from taking the medication paricalcitol (trade name Zemplar®) as compared to kidney~     transplant recipients not taking this medication. The main possible benefits being studied~     are:~        -  Lower risk for overactive parathyroid glands after kidney transplantation.~        -  Lower risk of low bone density in the spine and hip after kidney transplantation. By~          dividing patients in the study into a group receiving Zemplar® and a group not receiving~          Zemplar®, it will be possible to understand the good and bad effects of Zemplar® during~          the first year after a kidney transplant.~   "
226933|NCT00587145|"~     This study is an open-label, single center, and a single arm phase II study to evaluate the~     clinical response and safety of perioperative S-1 plus docetaxel. Perioperative chemotherapy~     is composed of 3 cycles of preoperative S-1/docetaxel and 3 cycles of postoperative~     S-1/docetaxel.Chemotherapy regimen:~        -  S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)~        -  Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8~   "
226934|NCT00587132|"~     The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive~     screening tool for pancreatic cancer in a high-risk population.~   "
226935|NCT00587119|"~     The purpose of the study is to find out the effects Budesonide, 9 mg daily for one year, has~     on patients with Primary Biliary Cirrhosis with features of autoimmune hepatitis.~   "
226936|NCT00587106|"~     This study is for patients with cancer, a known paraneoplastic syndrome, or neurological~     problems that suggest a paraneoplastic syndrome.~   "
226968|NCT00586677|"~     The purpose of this research is to evaluate specific parenting programs that aim to improve~     the family's ability to keep children physically safe and emotionally secure. We would like~     to learn more about how the treatments actually help families and to find out how an~     intervention that focuses on child health and safety compares with one that focuses on the~     parent and child relationship. We also want to determine whether participating in one program~     type versus the other results in further reports for child maltreatment.~   "
226937|NCT00587093|"~     The purpose of the research is to determine if blood tests and a CT scan done before surgery~     can predict how successful the surgery will be. In patients who have cancer of the ovary that~     has spread, it is hoped that the CT scan will be able to identify the various places where~     the cancer has spread so that additional surgeons can be available to help with the surgical~     procedure.~      If you have confirmed stage 3 or 4 ovarian, fallopian tube, or primary peritoneal cancer, you~     may undergo a CT scan of the abdomen and pelvis after the surgery to compare how much cancer~     the surgeon thought was left after surgery to what is seen on CT scan. A CT scan of the chest~     will be done if your physician thinks it is necessary.~   "
226938|NCT00587080|"~     To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal~     Rectal Resection (STARR)~   "
226939|NCT00587067|"~     This phase II study aims to evaluate regional chemotherapy in patients with unresectable~     primary hepatic malignancy. Specifically, eligible patients with hepatocellular carcinoma and~     peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary~     Surgery service, will undergo hepatic artery pump placement and continuous infusion of FUDR.~     The protocol includes radiological and biological correlative studies.~   "
226940|NCT00587054|"~     This is a phase II, single-center study to evaluate the efficacy of a novel cytoreductive~     regimen followed by CD34+E- selected T cell depleted allogeneic stem cell (or soybean~     agglutinated and E-rosetted BM) transplant as treatment for patients with acute and chronic~     leukemias, lymphoma and myelodysplstic syndrome/PNH. The impact of the change in conditioning~     regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and~     mortality and disease free survival will be assessed.~   "
226941|NCT00587041|"~     The purpose of this study was to determine the effect of two probiotic preparations~     (Agri-King Synbiotic and Oxadrop) on urinary oxalate excretion in patients with mild~     hyperoxaluria. Probiotics are live microorganisms thought to be beneficial to the host~     organism. Hyperoxaluria is a hereditary disorder that causes a special kind of stone to form~     in the kidney and urine. Oxalates are naturally-occurring substances found in plants,~     animals, and in humans. Excretion of oxalates in the urine is a risk factor for kidney stone~     formation.~      Our hypothesis was that the mild hyperoxaluria is due to over absorption of oxalate from food~     and that probiotics will improve gastrointestinal barrier function to decrease oxalate~     absorption across the gut (and hence its elimination in the urine).~      In the study, participants were randomized to placebo, Agri-King Synbiotic, or Oxadrop, and~     were treated for 6 weeks. Patients were maintained on a controlled diet to remove the~     confounding variable of differing oxalate intake and availability from food.~   "
226942|NCT00587028|"~     Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or~     larger without cathartic preparation.~   "
226943|NCT00587015|"~     A dose-escalation study to estimate the maximum tolerated dose(MTD) of CAT-8015 that can be~     safely administered to a patient.~   "
226944|NCT00587002|"~     The broad objective is to advance our understanding of both in vivo anatomical and functional~     changes that are present in the coronary arteries in women who have an acute coronary~     syndrome. Specific focus will be placed on the age of the women as there may be distinct~     differences in younger women (< 50 years) given the marked increase in mortality in this~     population.~   "
226945|NCT00586989|"~     This study is being done to determine if a new endoscope will help doctors identify~     pre-cancer or early cancer lesions in patients who have Barrett's esophagus. This new~     endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by~     modifying light.~   "
226946|NCT00586976|"~     Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a~     study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients~     undergoing cardiac surgery to see if it will be safe and result in improved pain control and~     reduced time to extubation, duration of ICU and hospital stay.~   "
226947|NCT00586963|"~     This study is being done to for two reasons:~        -  To learn about the effects (good and bad) esomeprazole (an FDA approved drug for reflux~          esophagitis) has on your esophagus when taken correctly.~        -  To learn about the quality of life changes (good and bad) you may experience with this~          medication.~   "
226948|NCT00586950|"~     The aim of this multi-center study is to determine the applicability of BMIPP to diagnosing~     cardiac disease and to predicting the outcome of patients on hemodialysis.~   "
226949|NCT00586937|"~     The purpose of this study is to find out about the quality of life of individuals who have~     been diagnosed and treated for lung cancer (lung cancer survivors). By quality of life, we~     mean how you are feeling about different aspects of your life, including your physical~     health, your emotional health, and your ability to carry out daily activities. We are~     interested in people's opinions about their quality of life, as well as the factors that~     affect their quality of life. Learning about quality of life will help us to develop new~     services for lung cancer survivors.~   "
226950|NCT00586924|"~     To administer the highest dose that can safely be given to a patient and establish the safest~     dose based on the highest tolerated dose for clinical testing.~   "
226951|NCT00586911|"~     To assess the safety and efficacy of betaine in patients with NASH on markers of disease~     severity such as liver histology, liver biochemistries, and health related quality of life.~   "
226952|NCT00586898|"~     Objective: To determine the response to rapid hormonal cycling in patients with non-castrate~     prostate cancer.~   "
226953|NCT00586885|"~     Purpose of this study is to assess the therapeutic efficacy of L-alanine in improving~     biological and histological findings by administrating 6-18g/day L-alanine for one year. We~     will also assess the safety and toxicity profile of long-term administration of L-alanine.~   "
226954|NCT00586872|"~     Existing records will be reviewed to evaluate the predictors of complications including~     stricture formation, bleeding or perforation associated with endoscopic mucosal resection~   "
226969|NCT00586664|"~     Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic~     conjunctivitis~   "
226970|NCT00586651|"~     This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of~     CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with~     Essential Thrombocytosis (ET).~   "
226955|NCT00586859|"~     The purpose of this study was to evaluate the safety and efficacy of placing multiple~     transmural sutures for the treatment of GERD.~      A prospective, multi-center, open-label trial was conducted at four centers in Germany to~     evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD.~     Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL)~     questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were~     heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication~     use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87%~     power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.~   "
226956|NCT00586846|"~     This study is designed to test the safety and feasibility of the simultaneous administration~     of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed~     patients.~   "
226957|NCT00586833|"~     This will be a cross sectional study comparing patients with HFpEF and age-matched, non-HF~     controls recruited from the community. This design will allow for determination of~     biologically relevant differences in baseline ventricular and vascular function, and~     importantly, differences in the ability to augment ventricular and vascular function~     dynamically during exercise stress, when symptoms of HF typically are first noted. The~     endpoint of exercise-reserve function is novel and has been little examined in the existing~     HFpEF literature.~   "
226958|NCT00586820|"~     Percutaneous coronary intervention (PCI) for acute coronary syndromes frequently fails to~     restore myocardial perfusion despite establishing epicardial vessel patency. Endothelin-1~     (ET-1) is a potent vasoconstrictor and its expression is increased in atherosclerotic~     coronary arteries. Our hypothesis is that increased activity of the endogenous endothelin~     system contributes to microvascular dysfunction, and adjunctive therapy with an endothelin~     receptor antagonist will result in improved microvascular blood flow.~      Aims: The aims of the study are to assess in patients with non ST-elevation myocardial~     infarction, whether: 1) PCI causes an increase in coronary blood ET-1 level; 2) an endothelin~     receptor antagonist acutely improves coronary microvascular blood flow following PCI.~      Non-ST segment elevation myocardial infarction (NSTEMI) is one type of heart attack. It is~     defined as the development of heart muscle necrosis results from an acute interruption of~     blood supply to a part of the heart which is demonstrated by an elevation of cardiac markers~     Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) in the blood and the absence of~     ST-segment elevation in ECG (electrocardiography). ST-segment is a portion of ECG, its~     elevation indicates full thickness damage of heart muscle. Absence of ST-segment elevation in~     NSTEMI indicates partial thickness damage of heart muscle occurs. Therefore, NSTEMI is less~     severe type of heart attack compared to STEMI (ST-segment elevation myocardial infarction) in~     which full thickness damage of heart muscle occurs.~   "
226959|NCT00586807|"~     The metabolic response to ulcerative colitis, including increased proteolysis and lipolysis~     and changes in energy expenditure, plays a significant role in the resulting malnutrition~     from which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory~     cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has~     been incriminated in the mechanism of weight loss in many different chronic diseases, and~     causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven~     to be an effective therapy for ulcerative colitis.~      The purpose of this study is to determine changes in protein and lipid metabolism, as well as~     resting energy expenditure, before and after therapy with anti-TNF-alpha antibody~     (infliximab) in children with ulcerative colitis. Performing this study will better define~     the changes in nutrition status observed in these children following remission of active~     ulcerative colitis, and potentially lead to changes in medical and nutritional management of~     these children~   "
226960|NCT00586794|"~     Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that~     constitutes a great burden at the individual as well as the familial and social level. The~     combination of critically increased pulmonary vascular resistance, progressive pressure load~     of the right ventricle and disturbance of pulmonary gas exchange result in long-term~     polymorbidity. The objective of this study is to provide evidence of improvement of patients~     exercise tolerance as well as general conditions by treatment with oral sildenafil as a~     specific pulmonary vasodilator.~   "
226961|NCT00586781|"~     The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with~     bilateral disease.~   "
226962|NCT00586755|"~     Patients with mantle cell lymphoma have a grave prognosis. They usually have an initial~     response to therapy, however progress early in the course of the disease and have very poor~     survival. We hypothesize that the emergence of drug resistance is responsible for this early~     failure of therapy and therefore intensive therapy at induction followed by high dose therapy~     immediately may produce a better outcome.~   "
226963|NCT00586742|"~     The purpose of this study is to evaluate whether there is a difference between conservative~     and operative treatment of Superior Labral Lesions(SLAP)of the shoulder.~   "
226964|NCT00586729|"~     This study will evaluate the efficacy, safety, and tolerability of topical Vashe™ Wound~     Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist versus~     5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing~     moist for a total treatment duration of 5 days.~   "
226965|NCT00586716|"~     The purpose of this study is to test the clinical and laboratory observations of IVIG therapy~     in the highly sensitized patient. We will study the effects of patients treated with IVIG or~     Cytogam in combination with plasmaphoresis to modulate the immune response in highly~     sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch~     that would allow living related transplant to take place or to shorten time on the transplant~     waiting list.~   "
226966|NCT00586703|"~     Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody~     selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation~     (SCT) from mismatched donors. This pilot study will evaluate toxicity including mortality,~     occurrence of acute graft versus host disease (aGVHD) and other severe toxicity.~   "
226967|NCT00586690|"~     Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody~     selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation~     (SCT) from matched donors. This pilot study will evaluate toxicity including mortality,~     occurrence of acute graft versus host disease and other severe toxicity.~   "
226973|NCT00586612|"~     The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity &~     safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK~     Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) & Wyeth's 7-valent pneumococcal conjugate~     vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the~     first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when~     co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in~     the second year of life (16-18 months of age). The control is a group of full-term infants~     receiving the same vaccines. The Protocol Posting has been updated in order to comply with~     the FDA Amendment Act, Sep 2007.~   "
226974|NCT00586599|"~     The goal in these studies will be to assess the relative levels of the Stat4 alpha and Stat4~     beta isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, celiac disease~     or from control patients. We hypothesize that the beta to alpha ratio will be higher in~     patients with active disease and that there will be a correlation between the ratio and the~     severity of disease.~   "
226975|NCT00586586|"~     The study aims to evaluate the effectiveness of a cognitive behaviour therapy program~     (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child~     and adolescent mental health clinics in Western Norway.~   "
226976|NCT00586573|"~     The primary objective of the study is to assess the efficacy and tolerability of a 12-week~     trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD~     and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the~     investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a~     questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening~     in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine~     hydrochloride will be associated with improving ADHD symptoms and associated deficits in~     executive functions. We also expect that memantine will be well-tolerated with predictable~     adverse events.~   "
226977|NCT00586560|"~     This is a Phase 1, open-label, single-center, dose-escalating study in pediatric patients~     with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata,~     depending upon the presence bone marrow metastases or previous treatment with intensive~     myelosuppression therapy. Patients will receive Karenitecin along with cyclophosphamide daily~     for 5 consecutive days, every 21 days (1 treatment cycle). Treatment may continue for up to~     20 cycles, as long as there is continued evidence of clinical benefit and an absence of~     unacceptable toxicity.~   "
226978|NCT00586547|"~     This study is designed to determine the number of donor lymphocytes that can be given to~     recipients of haploidentical stem cell transplants after depletion of recipient-reactive T~     lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result~     in a rate of Grade III/IV GVHD of < / = 25%, to analyze immune reconstitution in these~     patients, and to measure their overall and disease free survival, at 100 days and at 1 year.~   "
226979|NCT00586534|"~     The purpose of our research is to examine the promise of a new computer based approach to use~     in usual drug counseling when treating crack cocaine addiction.~   "
226980|NCT00586521|"~     The purpose of the study is to evaluate the effect of prophylactic treatment on the number of~     joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand~     treatment in a one-group two-treatment schedule design.~      In addition, the effect of prophylactic treatment on the joint function, the number of all~     bleeds, and on the quality of life compared to on-demand treatment and health-economic data~     will be assessed.~   "
226981|NCT00586508|"~     The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment~     recurrent malignant gliomas.~   "
226982|NCT00586495|"~     Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients~     with renal cell carcinoma (RCC).~   "
226983|NCT00586482|"~     The goal of this pilot study is to determine the feasibility and potential effect size of~     nicotine lozenges as an adjunct to maintain brief preoperative abstinence, defined as not~     smoking the day of surgery.~   "
226984|NCT00586469|"~     Vaccination is currently the most effective means of controlling influenza and preventing its~     complications and mortality in persons at risk.~      Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a~     recommendation on the influenza A and B strains that should be used for the production of~     vaccine for the coming influenza season. For the strains which do not change from the~     previous year, the vaccine can be formulated from the old mono bulk from the previous year.~      Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under~     the current Canadian and US licenses. This study is conducted to evaluate safety and~     immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new~     bulk material. This protocol posting has been updated in order to comply with the FDA~     Amendment Act, Sept 2007.~   "
226985|NCT00586443|"~     Targeting molecular pathways of tumor growth has become a major focus of anti-cancer~     treatments. This study aims to investigate the toxicity, pharmacokinetics, and preliminary~     efficacy of the triplet combination of bevacizumab, RAD001, and panitumumab in patients with~     refractory solid tumors.~      This open-labeled, non-randomized phase I trial of bevacizumab, everolimus and panitumumab is~     designed to assess the safety, tolerability and efficacy of this combination in adult~     patients with advanced solid tumors.~   "
226986|NCT00586430|"~     We expect the results of this pilot study to justify a larger study that follows people to~     determine if certain tests of memory and attention, performed while sleepiness is induced by~     a single dose of lorazepam (a widely used anti-anxiety medication) could predict an~     individual's risk of developing AD. We plan to compare cognitively normal people who possess~     a common gene that increases risk for AD— the apolipoprotein E (APOE) e4 allele—to~     individuals without this gene. We hypothesize that a single 2 mg dose of lorazepam will cause~     more cognitive impairment in carriers of the APOE e4 allele than in noncarriers, and that the~     carriers will recover more slowly from these impairments than noncarriers.~   "
226987|NCT00586417|"~     The overall goal of this study is to determine the feasibility and the variability of several~     biomarker assays in normal subjects that are relevant to tumor biology and novel anti-cancer~     treatments, with the goal of refining these assays for use in future therapeutic studies.~   "
245159|NCT00344955|"~     We wanted to test the acute effect of HMG-CoA reductase inhibition (atorvastatin) on renal~     hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.~   "
226988|NCT00586404|"~     This trial is a multi-center clinical and endoscopic outcomes project involving a single~     large database of patients with Barrett's Esophagus (BE). The initial goal of this project is~     to define the incidence and prevalence of cancer and high-grade dysplasia (HGD) in patients~     with BE. Thus, our hypothesis is that systematic collection of data on the natural history of~     BE and risk factors for progression of BE will provide useful information to develop a~     decision model for risk stratification and risk reduction strategies in BE.~   "
226989|NCT00586391|"~     Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma, Acute~     Lymphocytic Leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as~     Lymphoma or Leukemia). Their Lymphoma or Leukemia has come back or has not gone away~     after treatment (including the best treatment known for these cancers). This research study~     is a gene transfer study using special immune cells.~      The body has different ways of fighting infection and disease. No one way seems perfect for~     fighting cancers. This research study combines two different ways of fighting disease,~     antibodies and T cells, hoping that they will work together. Antibodies are types of proteins~     that protect the body from bacterial and other diseases. T cells, also called T lymphocytes,~     are special infection-fighting blood cells that can kill other cells including tumor cells.~     Both antibodies and T cells have been used to treat patients with cancers; they have shown~     promise, but have not been strong enough to cure most patients.~      T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the~     tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in~     the laboratory and then given them back to the person.~      The antibody used in this study is called anti-CD19. It first came from mice that have~     developed immunity to human lymphoma. This antibody sticks to cancer cells because of a~     substance on the outside of these cells called CD19. CD19 antibodies have been used to treat~     people with lymphoma and Leukemia. For this study anti-CD19 has been changed so that instead~     of floating free in the blood it is now joined to the T cells. When an antibody is joined to~     a T cell in this way it is called a chimeric receptor.~      In the laboratory, investigators have also found that T cells work better if they also put a~     protein that stimulates T cells called CD28. Investigators hope that adding the CD28 might~     also make the cells last for a longer time in the body.~      These CD19 chimeric receptor T cells with C28 T cells are investigational products not~     approved by the Food and Drug Administration.~      The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to~     see how the T cell with this sort of chimeric receptor lasts, to learn what the side effects~     are and to see whether this therapy might help people with lymphoma or leukemia.~   "
226990|NCT00586378|"~     The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio~     DR and VR ICDs~   "
226991|NCT00586365|"~     Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification).~     This new bone is unwanted and it can restrict motion. This research study is being done to~     learn more about the effect of the drug naproxen, on unwanted formation of new bone around~     the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs~     which stands for non-steroidal anti-inflammatory drugs.~      Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted~     formation of new bone around the hip. The effect of NSAIDS on the formation of bone around~     the elbow has not been studied as well as it has been studied for their effect on the hip.~      The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot~     specifically for the treatment of heterotopic ossification.~   "
226992|NCT00586352|"~     Inflammatory bowel disease, which includes both Crohn's disease and ulcerative colitis, is a~     disease of the gastrointestinal tract leading to symptoms of abdominal pain, diarrhea, and~     growth disturbance. Crohn's disease is a chronic inflammatory process that may affect any~     part of the gastrointestinal tract, whereas ulcerative colitis is typically present only in~     the colon. Children with inflammatory bowel disease frequently suffer from disturbances in~     growth, which may continue into adulthood and result in altered growth outcomes. The~     metabolic response to inflammatory bowel disease, including increased protein breakdown and~     decreased protein synthesis may play a significant role in the resulting malnutrition and~     growth failure from which children with inflammatory bowel disease suffer. The purpose of~     this study is to compare the rates of protein synthesis within the mucosal lining of the~     gastrointestinal tract in children Crohn's disease or ulcerative colitis to children who have~     normal endoscopic examinations. By comparing children with inflammatory bowel disease to~     normal children, we can begin to determine how alterations in protein metabolism within the~     lining of the gastrointestinal tract affect whole body protein metabolism, and its consequent~     effects on growth. In those patients diagnosed with Crohn's disease or ulcerative colitis, a~     follow-up study will be conducted two weeks following the initiation of steroid therapy to~     determine its effects on protein metabolism. We hypothesize that children with active~     inflammatory bowel disease will have increased rates of protein synthesis in the lining of~     the gastrointestinal tract than patients who have normal endoscopy, and that increases in~     protein breakdown and protein synthesis will be improved following steroid therapy in~     children with newly diagnosed inflammatory bowel disease.~   "
226993|NCT00586339|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. The current study is designed to evaluate the safety and immunogenicity~     of GlaxoSmithKline Biologicals' HPV vaccine 580299 in HIV infected adult females living in~     the Republic of South Africa. The study is double blinded, randomized for HIV positive~     subjects and open for HIV negative subjects. The Protocol Posting has been updated in order~     to comply with the FDA Amendment Act, Sep 2007.~   "
226994|NCT00586326|"~     This study has been designed to compile information on the efficacy of the MammoSite RTS~     providing sole radiation therapy for patients with pure DCIS.~   "
226995|NCT00586313|"~     Endoscopic Ultrasound involves the placement of a small flexible camera through the mouth and~     into the stomach to image various parts of the body. A small piece of tissue called a biopsy,~     of your liver nay be obtained by this method. the tissue (biopsy) would be obtained by~     inserting a small needle through the lining of the stomach into the liver. Consideration for~     this biopsy is because there may be extra fat stored within the liver. In some people who~     drink too much alcohol, extra fat may be stored in the liver, however, in some people who~     don't drink too much alcohol, this may also occur and is called :non-alcoholic fatty liver~     disease or NAFLD. Over time, this extra fat may lead to liver irritation and scar tissue~     called cirrhosis. If NAFLD is detected early enough, then treatment with medications, losing~     weight, or dietary changes may help avoid cirrhosis. the purpose of this study is to learn~     about whether doctors can obtain the biopsy from the liver by a new method. The biopsy of the~     liver allows the doctors to look for any signs of scar tissue or inflammation from any cause.~   "
226996|NCT00586300|"~     Osteoarthritis (OA) is the most common joint-related disease and most prevalent form of~     arthritis in the United States. Pain relievers and anti-inflammatory medications are the most~     commonly prescribed treatments for OA. These medications, however, cannot completely~     alleviate OA symptoms. Additional recommended strategies for managing OA include physical and~     occupational therapy, exercise, and patient education. This study will compare the~     effectiveness of a physical training program, a self-management training program, and a~     program including both physical and self-management training for improving physical function~     in people with early stage knee OA.~   "
226997|NCT00586287|"~     Oral anticoagulation is often initiated in hospitalized patients. Although the therapeutic~     range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly~     between persons. Our group recently developed two dosing algorithms for the initiation of~     anticoagulation based on clinical predictors such as age, gender, body weight and laboratory~     values.~      The aim of the proposed study is to prospectively evaluate the efficacy and safety of these~     two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients and~     possibly in a geriatric collective.~   "
226998|NCT00586274|"~     While stem cell transplantation has proven an effective means of treating a wide variety of~     diseases involving hematopoietic stem cells and their progeny, a shortage of donors has~     proved a major impediment to the widest application of the approach. Until recently, only MHC~     identical donors could be used with safety. Such donors were originally siblings or other~     closely related family members. Over the past decade, the growth of allogeneic donor panels~     has allowed transplantation with stem cells obtained from a volunteer donor panel.~      While it is now possible to obtain HLA identical unrelated donor stem cells for approximately~     75% of individuals of Northern European backgrounds, the situation for most other ethnic~     groups is much less satisfactory. Even when a matched donor can be found, the elapsed time~     between commencing the search and collecting the stem cells usually exceeds three months, a~     delay that may doom many of the neediest patients. Hence there has been considerable interest~     in making use of HLA haploidentical family donors. Most individuals have a first-degree~     relative who would be suitable for such protocols. Fanconi anemia (FA) is an autosomal~     recessive disorder characterized by the development of progressive aplastic anemia usually~     evident by about age seven years and often associated with various diverse congenital~     anomalies such as short stature, microcephaly, radial anomalies, horseshoe kidney, and cafe~     au lait spots.~      This study will determine the number of donor lymphocytes that can be given to recipients of~     haploidentical stem cell transplants with Fanconi anemia after depletion of~     recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA~     immunotoxin, and will result in a rate of Grade III/IV GVHD of < / = 25%.~   "
226999|NCT00586261|"~     The hypothesis of the current proposal is that chronic pioglitazone therapy will result in~     improved endothelial function, decreased inflammation, and preservation of renal function in~     patients with CKD but without diabetes.~   "
227000|NCT00586248|"~     In this prospective pilot study, we proposed to evaluate the effects of left interscalene~     stimulation on cardiac pacemaker function.~   "
227001|NCT00586235|"~     Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic~     or renal lesions to serve as sample data sets for fusion algorithm development and subsequent~     optimization.~   "
227002|NCT00586222|"~     This study is being done to detect the metabolic changes that Omega 3 fatty acid treatment~     has on the brain and to find out whether magnetic resonance spectroscopy (MRS) scan can~     detect metabolic differences between bipolar patients and healthy control participants.~   "
227003|NCT00586209|"~     To primary purpose is to evaluate the effect of L-glutamine therapy on exercise endurance and~     breath by breath exercise response of sickle cell anemia patients~      The secondary purpose is to assess the effect of L-glutamine on pain; energy and appetite~     levels; narcotics usage; and hospital and emergency room visits for sickle cell pain~   "
227004|NCT00586196|"~     Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with~     substantial morbidity within the hospital and beyond. Particular patient populations are at~     high risk for poor outcomes after an episode of delirium. Patients with hip and other long~     bone fractures are at increased risk of developing delirium (acute confusion) which impedes~     functional recovery. This is a pilot study to test the tolerability and efficacy of~     donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for~     the prevention of new or worsening delirium in aged hip and other long-bone fracture~     patients. Additional purposes involve gathering a small amount of patients' serum to better~     understand the pathophysiology of delirium in this population.~      The purposes of this pilot study are to determine: 1) the safety and tolerability a~     cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To~     obtain estimates of subject accrual and preliminary estimates of effect size on the~     development of new delirium symptoms to allow for planning of a larger, definitive trial, 3)~     To better understand the underlying causes of delirium by examining whether a measure of~     blood anticholinergic activity relates to the incidence and persistence of delirium symptoms,~     and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and~     delirium symptoms.~   "
227005|NCT00586183|"~     Our hypothesis is that altered cardiac sympathetic activity is present and may contribute to~     the myocardial stunning observed in the apical ballooning syndrome.~      Aim: Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction using~     carbon-11 hydroxyephedrine (C-11 HED), a positron emission tomography (PET) tracer, in~     patients with the apical ballooning syndrome.~   "
227006|NCT00586170|"~     The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th~     metatarsal non-union fractures.~   "
227007|NCT00586157|"~     The purpose of this study is to investigate the effectiveness of a medication skin patch~     called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a~     placebo patch. We want to find out how well it treats ADHD during the early morning hours~     before a child leaves for school or summertime routines.~   "
227008|NCT00586131|"~     This study will test the hypothesis that by slightly lowering the acidity of blood (or~     increasing the pH), dialysis patients utilize protein and amino acids more efficiently.~   "
227009|NCT00586118|"~     The evaluation of the presented study will work on the practicability of inhalative sedation~     on the ICU, potential benefits and limitations of the ACD system in a postoperative sedated~     patient population in comparison to a standard intravenous sedation regimen with propofol,~     and focus on renal and hepatic function, cardioprotection and pharmacoeconomics~   "
227010|NCT00586105|"~     A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic~     renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability,~     and efficacy.~   "
227011|NCT00586092|"~     The primary objective of this study is to determine the recommended Phase II dose for the~     combination of ABT-510 plus bevacizumab in patients with advanced solid tumors and to~     evaluate dose limiting toxicities and non-dose limiting toxicities of this combination. The~     secondary objectives are to collect preliminary data on the effect of the combination of~     ABT-510 plus bevacizumab versus each agent individually on dermal wound angiogenesis in a~     skin biopsy and to collect preliminary data on the clinical activity of this combination~     (tumor response rate, progression-free survival, rate of stable disease > 6 months).~   "
227012|NCT00586079|"~     The purpose of this study is to determine the effect of deep brain stimulation surgery on~     movement-related cortical potentials in patients with Parkinson's disease.~   "
227013|NCT00586066|"~     The purpose of this study is to see whether memantine improves memory function in~     participants with bipolar disorder who have minimal symptoms. Secondary analyses will test~     the role of memantine in improving residual mood symptoms (depression and mania) in~     participants with bipolar disorder.~      We hypothesize that in participants with bipolar disorder who have minimal symptoms memantine~     will be effective in improving cognitive functions, as measured by the difference in~     neuropsychological test scores at the beginning and at the end of the trial.~   "
227014|NCT00586053|"~     It is our objective to improve the performance of CTC in the prepared colon, and to validate~     CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness~     ratio of CTC in the unprepared colon will compare favorably with other colorectal screening~     test.~   "
227015|NCT00586040|"~     The broad aim of this study is to evaluate the efficacy of photochemical tissue bonding (PTB)~     for the closure of skin excisions. We will test the hypothesis that full thickness skin~     excisions treated with PTB can heal with less scarring than those treated with the~     conventional suture closure method.~   "
227016|NCT00586027|"~     Low output syndrome is a common complication in patients undergoing cardiac surgery. Its~     incidence was reported to be 2 to 6%. Morbidity and mortality of low output syndrome is high~     and the costs for treating the disease are immense.Natriuretic propeptide Type B (NT-proBNP)~     is a biological marker for the diagnosis, prognosis and therapy of cardiac failure after~     cardiac surgery.~      Cardiac index and NT-proBNP will be correlated with morbidity and mortality. A critical~     threshold value for intraoperative cardiac index and NT-proBNP will be calculated.~   "
227017|NCT00586014|"~     The purpose of this phase II study is to assess the toxicity and efficacy of sequentially~     administered high dose chemotherapy followed by autologous stem cell rescue in the treatment~     of multiple myeloma. Prior studies have shown that dose-intensified melphalan can produce~     higher response rates and complete remission in some patients. Over the past several years,~     multiple phase II studies utilizing high dose chemotherapy or high dose chemo-radiotherapy~     with autologous marrow or peripheral blood stem cell rescue have demonstrated improved~     response rates and survival rates compared to historical controls. Recently a prospective~     randomized trial has demonstrated improved response rates, response duration and overall~     survival utilizing high dose therapy with autologous bone marrow support compared to standard~     chemotherapy. The primary cause of failure is relapse and it is unclear how many, if any,~     patients are cured by this approach. Based on observations of efficacy in Hodgkin's Disease,~     Non-Hodgkin's Lymphoma, and breast cancer, an approach utilizing sequential high dose~     chemotherapy in multiple myeloma was developed. This protocol tests the sequential regimen in~     multiple myeloma patients who have responded to a standard dose chemotherapy regimen prior to~     enrollment.~   "
227018|NCT00586001|"~     The purpose of this study is to develop a new psychological therapy for a variety of~     different types of emotional disorders. The study will compare symptoms and functioning of~     clients who receive the treatment with those who do not, and will include a number of~     assessments before, during, and after treatment. We predict that patients receiving active~     treatment will show improved functioning relative to wait-list control.~   "
227019|NCT00585988|"~     The primary purpose of this study is to compare early functional outcomes in patients~     undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more~     objective measures of function.~   "
227020|NCT00585975|"~     This is a safety and efficacy study of bromfenac ophthalmic solution~   "
227021|NCT00585962|"~     The primary purpose of this study is to determine if high doses of radiation using proton~     beam can be given safely with low and acceptable side effects. This study will also gather~     data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam~     radiation is a very accurate kind of treatment that has been shown to affect less normal~     tissue than a regular radiation beam.~   "
227022|NCT00585949|"~     This study will help to permit the development of preventative strategies as well as~     cell-cased therapy for existent disease. It is hypothesized that aging is associated with~     reduced vascular injury-induced endothelial progenitor cell activity, resulting in impaired~     vascular repair and increased vascular disease. Patients with stable coronary artery disease~     and a control group of patients undergoing coronary angiography without angioplasty will be~     recruited.~   "
227023|NCT00585936|"~     The purpose of this study is to determine whether magnetic resonance imaging (MRI) with~     ferumoxtran-10 can be used to detect changes in the pancreas associated with autoimmune~     diabetes.~   "
227024|NCT00585923|"~     The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior~     Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.~   "
227025|NCT00585910|"~     The purpose of this study is to evaluate the safety, effectiveness, and tolerability of~     atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children~     and adolescents ages 6-17.~   "
227026|NCT00585897|"~     Purpose The purpose of this study is to investigate the effects of discontinuation of sugar~     sweetened beverages on hemoglobin A1c (HbA1c) and plasma fasting and post-prandial blood~     glucose in a population with type 2 diabetes.~      Hypothesis Elimination of sugar sweetened beverages from the diet for a 4 week period will~     lead to a decrease in HbA1c and plasma fasting and 2 hour post prandial blood glucose in a~     population with a history of type 2 diabetes and high consumption of sugar sweetened~     beverages.~      Specific aims to test hypothesis~        1. Investigate how elimination of sugar sweetened beverages from the diet affects HbA1c and~          plasma fasting and two hour post prandial blood glucose.~        2. Test the feasibility of carrying out a simple diet intervention in an outpatient~          population with type 2 diabetes.~   "
227027|NCT00585884|"~     Following placement of silicone breast prosthetics for reconstruction~   "
227048|NCT00585598|"~     In the trauma setting, if a patient has arrived in the trauma bay with an ETC/King LT-D in~     place, it has traditionally been immediately exchanged out for an ETT upon arrival. The~     timing of the exchange has never been adequately defined in terms of safety. This study is a~     prospective clinical trial designed to evaluate the safety of supralaryngeal, ETC/King LT-D~     tube, exchange [either in the operating room (if immediate surgery is required) or after~     stabilization in the trauma bay/intensive care unit according to the protocol adapted~     previously by UWHC.~   "
227028|NCT00585871|"~     Cardiac arrest or sustained VT (ventricular tachycardia) in patients with heart disease is~     best treated with an ICD (implantable cardioverter defibrillator). However, the ICD alone is~     not appropriate therapy for patients with frequent VT episodes. In fact frequent shocks for~     VT may predict a poorer prognosis. Anti-arrhythmic drugs are co-administered with ICDs in up~     to 50% of patients to prevent VT episodes, but antiarrhythmic drugs may have harmful effects.~     Thus improved drugs to prevent VT without interfering with ICD function are needed. Recent~     data including our own suggest that clonidine may be a new therapy to prevent ICD shocks. It~     may act centrally on sympathetic outflow and peripherally and selectively on cardiac~     Purkinje, to suppress and control VT occurring in patients. Our purpose is to test the~     hypothesis that clonidine reduces frequent VT better than beta blocker in patients with ICDs.~     After informed consent patients will be randomized in a single blind fashion to either~     clonidine or metoprolol given three times per day. Other prescribed drugs may be adjusted to~     promote toleration of the study drug. ICD interrogations of episodes of VT will be the~     primary endpoint. Device based NIPS (non-invasive programmed stimulation) testing in a subset~     of these patients will allow mechanistic understanding of the clonidine effect. All of the~     procedural techniques are in place as performed clinically; preliminary data are given~     showing feasibility of the project.~   "
227029|NCT00585858|"~     The purpose of this pilot study is to determine if there is clinical correlation between the~     CKT and transplant recipients who are known to be on minimal or no immunosuppression~     (presumed tolerant) and those who are on conventional amounts of immunosuppression and have~     either experienced rejection (presumed hyper-responsive to donor) or have not experienced~     rejection (unknown responsive state).~   "
227030|NCT00585845|"~     This clinical trial will evaluate the safety and tolerability of CRS 207 an investigational~     product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria~     that is commonly found in the environment. CRS-207 has been altered in the lab to reduce its~     ability to cause disease, while maintaining stimulation of the immune system. CRS 207 has~     also been genetically modified with recombinant DNA to release an antigen called Mesothelin.~     Because CRS 207 stimulates an immune response to Mesothelin and Mesothelin may be present at~     higher levels on tumor cells than on normal cells, this clinical trial will also examine if~     CRS 207 boosts the immune system in a way that targets certain types of cancer.~      The purpose of this first clinical trial with CRS-207 is to identify an appropriate dose of~     the investigation agent for later clinical studies and to explore safety when given to~     consenting adults with advanced cancer of the ovary or pancreas, non-small cell lung cancer,~     or advanced malignant epithelial mesothelioma. Immunological response to CRS-207 and tumor~     status of study participants will also be measured. Patients who choose to enter the study~     must meet all study entry criteria and must have previously failed standard treatment for~     their cancer. Qualifying study patients will be assigned to receive one of several dose~     levels of CRS-207. Each patient may receive up to 4 intravenous administrations (21 days~     apart) of CRS-207 at their assigned dose level.~   "
227031|NCT00585832|"~     The purpose of this study is to examine the long term effects of a 24-week clinically-based~     behavioral nutrition intervention emphasizing the DASH diet compared to routine nutrition~     care on changing diet quality, blood pressure, hypertension status, and vascular function in~     adolescents with elevated blood pressure.~   "
227032|NCT00585819|"~     The overall, broad objective of this study is to pilot the BSD technique. The specific~     purpose of this particular study is to generate pilot data to validate several crucial steps~     of the BSD technique, in particular steps 1, 2, and 4. Radiation treatments will proceed per~     standard of care, and will not be modified in any way during this protocol. This study is a~     non-treatment protocol.~   "
227033|NCT00585806|"~     This study will compare the ability of the heart to increase its contractile performance~     during stress in patients with a history of heart failure without systolic dysfunction and in~     controls.~   "
227034|NCT00585793|"~     Does subtype of HIV-1 affect the response of ARVs given to Ugandan children~   "
227035|NCT00585780|"~     To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment~     seeking alcohol dependent individuals. This proposal is a laboratory and treatment outcome~     study to examine the effects of Prazosin on brief exposure to stress, drug cues and neutral~     situations on alcohol and drug craving, mood and neurobiological reactivity in a sample of~     cocaine and/or alcohol dependent individuals. Prazosin will be beneficial for reduction in~     stress and drug cue induced craving and related arousal. In a sample of 120 alcohol dependent~     men and women, we propose to examine (a) differences in measures of cocaine craving, emotion~     state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma~     catecholamine response to stress imagery and to drug cue imagery as compared to neutral~     imagery; (b) reduction in alcohol abstinence symptoms; and (c) improvement in alcohol~     treatment outcomes as measured by increasing abstinence, reduction in alcohol use, increased~     treatment attendance and decreased relapse risk.~   "
227036|NCT00585767|"~     This is a clinical feasibility study to assess the value of MR imaging for obtaining~     functional, dynamic and anatomical information in a comprehensive imaging protocol in~     subjects having obstructive uropathy.~   "
227049|NCT00585585|"~     The purpose of this study is to determine a dose of the investigational drug betahistine~     dihydrochloride that is both well tolerated and potentially effective in treating the~     symptoms of atypical depression. Atypical depression is characterized by the ability of the~     person's mood to improve temporarily in response to positive events, as well as features such~     as increased appetite, increased sleep and severe fatigue.~   "
227050|NCT00585572|"~     The Wisconsin Brain Donor Program (WBDP) stores brain and other tissues/samples (e.g. blood~     and CSF) from deceased individuals who have participated in longitudinal research studies, as~     well as other select participants. These individuals have donated their tissues in order to~     aid scientific research. Through the collection of central and peripheral nervous tissues as~     well as (in select cases) skeletal muscle tissue, the WBDP strives to advance the knowledge~     of diseases of memory disorders, such as Alzheimer's Disease. Brain donations are needed from~     healthy individuals, as well as those affected by diseases of the nervous system.~   "
227051|NCT00585559|"~     The objective of this study is to determine whether acetaminophen (APAP), N-acetylcysteine~     (NAC), and APAP in combination with NAC will inhibit lipid peroxidation in aneurysmal~     subarachnoid hemorrhage (aSAH), utilizing F2-IsoPs as biomarkers for lipid peroxidation.~   "
227037|NCT00585754|"~     This study aims to test the preliminary efficacy of 3.0 mg of guanfacine (GFC) daily versus~     placebo in cocaine and/or alcohol dependent individuals. This proposal is a laboratory and~     treatment outcome study to examine the effects of guanfacine on brief exposure to stress,~     drug cues and neutral situations on cocaine/alcohol craving, mood and neurobiological~     reactivity in a sample of cocaine and/or alcohol dependent individuals. Guanfacine will be~     beneficial for reduction in stress and drug cue induced craving and related arousal. In a~     sample of 60 cocaine and/or alcohol dependent men and women, we propose to examine (a)~     differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal~     (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery~     and to drug cue imagery as compared to neutral imagery; (b) reduction in cocaine/alcohol~     abstinence symptoms; and (c) improvement in cocaine and alcohol treatment outcomes as~     measured by increasing abstinence, reduction in cocaine/alcohol use and increased treatment~     attendance. Hypothesis 1: Guanfacine will decrease stress-induced cocaine craving, negative~     emotions and related arousal in the laboratory as compared to placebo. Hypothesis 2a: As~     compared to the PLA group, the GFC group will show significant reductions in protracted~     withdrawal symptoms as measured by the CSSA/CIWA during the 9-week treatment period.~      Hypothesis 2b: As compared to the PLA group, a higher percentage of the GFC patients will~     remain abstinent during the 9-week treatment period with a higher percent of negative cocaine~     urines and alcohol-free days.~      Hypothesis 2c: The GFC group will show greater adherence to treatment as measured by the days~     in treatment as compared to the Pla group.~   "
227038|NCT00585741|"~     Fractionated radiotherapy induces an observable change in the proliferative activity as~     assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to~     investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several~     tumors and will serve as a pilot study to a planned PO1 submission~   "
227039|NCT00585728|"~     The purpose of this study is to see how CT virtual proctoscopy compares to an ultrasound exam~     of the rectal area in determining the stage of rectal cancer for people recently diagnosed~     with rectal cancer. This study will also compare tumor volume before and after neoadjuvant~     therapy using CT virtual proctoscopy, with the ultrasound exam as a comparison. Neoadjuvant~     therapy consists of chemotherapy and radiation therapy. Neoadjuvant chemoradiation therapy is~     done before surgery to reduce the size of tumors.~   "
227040|NCT00585715|"~     The purpose of this research study is to evaluate effectiveness of a non-ablative (does not~     remove skin) treatment for cellulite (dimpled fat) in conjunction with skin tightening using~     the Candela GentleYAG laser.~   "
227041|NCT00585702|"~     The purpose of this study is to learn about the effects of bipolar disorder or the use of~     antimanic medications on the mother's health and wellbeing during pregnancy and for the first~     postpartum year. Infant health and development are also assessed during the first year.~     Participation in the study includes 7 study visits, three in pregnancy and four postpartum.~   "
227042|NCT00585689|"~     Study participants will have been diagnosed with bladder cancer that has invaded the muscle~     wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the~     bladder. Unfortunately, approximately 50% of people may have their cancer return in another~     location. For this reason, researchers are focusing on new chemotherapy regimens to be given~     before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.~      Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder~     cancer cells.~      ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard~     paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated~     castor oil). However, these additives are felt to contribute to the side effects (possibly~     severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver~     more drug to tumor cells. ABI-007 is approved by the United States Food and Drug~     Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being~     evaluated in other cancers in research studies.~      This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin~     and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.~   "
227043|NCT00585676|"~     It is known that administration of steroids increases blood sugar levels. Administration of~     betamethasone is common practice during pregnancy to women at risk for preterm delivery.~     However, it is unknown the magnitude of the changes in glucose these women have after~     receiving betamethasone. The purpose of this study is to determine the magnitude and timing~     of the increase in blood sugar in pregnant women without diabetes who receive steroids.~   "
227044|NCT00585650|"~     The purpose of this research study is to see how well (compared to placebo) Enbrel®~     (etanercept) 50 mg twice a week affects plaque psoriasis of the hands and/or feet~     (Palmoplantar Psoriasis)~   "
227045|NCT00585637|"~     This study will help us know the effects of Vitamin D pills in Blacks. The results of this~     study may be the first step in creating ways to prevent the risks of colon and prostate~     cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among~     Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels~     in our bodies.~   "
227046|NCT00585624|"~     We are proposing to evaluate the benefit of preoperative nutritional support with Impact~     Advanced Recovery in the most vulnerable group of elective gastrointestinal surgery patients~     who may experience a complication, esophagus and pancreas resections, and hypothesize that~     oral supplementation with 3 servings (0.75 L) Impact Advanced Recovery will reduce~     postoperative stay by 10-20% and reduce the incidence of major complications by 25%.~   "
227047|NCT00585611|"~     The study is designed to define the underlying vascular abnormalities present in patients~     with diastolic heart failure and test the effect of a therapy aimed at vascular~     abnormalities. This study is designed to investigate the effects of therapy with atorvastatin~     in subjects with diastolic heart failure to improve abnormalities of vascular and myocardial~     structure and function, with particular emphasis on arterial stiffness and endothelial~     dysfunction.~   "
227130|NCT00584519|"~     To analyse the progress of modifiable metabolic risk factors (Blood pressure, cigarette~     smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with~     overweight for 12 months.~      To analyse the perceived health status and the level of functioning and disability of~     patients with schizophrenia and overweight and their progress at 3, 6 and 12 months.~      To assess the progress of the symptoms of the disease at 6 and 12 months.~   "
227052|NCT00585546|"~     The purpose of this study is to evaluate whether patients with chronic heart failure not due~     to coronary artery disease who require use of a left ventricular assist device (LVAD) for~     refractory heart failure can recover sufficient heart function to allow the pump to be~     explanted. The study aims to avoid the need for transplantation in these patients by using~     standard heart failure medications to reduce the size of the left ventricle and then using~     the investigational drug, clenbuterol, to further improve left ventricular function.~   "
227053|NCT00585533|"~     This study will evaluate Tarceva in a selected population of patients with untreated advanced~     non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis~     based on clinical criteria. It is anticipated that selection will enrich for tumor~     characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater~     than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for~     patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at~     some point in the future and may prolong the time to chemotherapy related progression.~      Patients will remain on study until disease progresses, a decline in performance status, if~     patient cannot tolerate the side effects or develops symptoms requiring conventional~     chemotherapy.~   "
227054|NCT00585520|"~     Cocaine dependence is a chronic, relapsing disorder in which stress/negative mood and~     exposure to drug-related stimuli or cues are associated with high rates of relapse (McKay~     et al., 1995; O'Brien et al., 1998; R. Sinha, 2001; Shaham et al., 2003). In particular, sex~     differences in relapse precipitants have been noted, with women reporting greater stress~     related relapses while men report higher number of relapses associated with drug~     cue/temptation situations (Lex, 1991; McKay et al., 1996; R. Sinha, 2001; R. Sinha,~     Rounsaville BJ, 2002). Current SCOR studies have shown that stress and cocaine cues increase~     drug craving and stress related arousal, responses that differ in cocaine men and women (R.~     Sinha et al., 2003; H.C. Fox et al., 2005a). Furthermore, stress-induced cocaine craving and~     HPA responses are predictive of cocaine relapse, which is also moderated by gender (R. Sinha~     et al., 2006). However, no previous research has examined the basis of sex differences in~     stress and cue induced craving and arousal, both of which are known to increase relapse~     susceptibility. Greater knowledge of the sex-specific neurobiology of cocaine dependence will~     facilitate development of gender-specific cocaine relapse prevention efforts.~      Growing evidence supports a role for gonadal hormones in explaining the sex differences~     observed in stress responses as well as in the behavioral responses to cocaine (Festa &~     Quinones-Jenab, 2004; K. Carroll, Fenton LR, Ball SA, Nich C, Frankforter TL, Shi J,~     Rounsaville BJ, 2004; Lynch, 2006; Kajanti & Phillips, 2006). Estrogen increases behavioral~     responses to cocaine, while presence of progesterone decreases subjective and behavioral~     effects of cocaine, more so in females than males (Jackson et al., 2006; Sofuogu et al.,~     1999; M. Sofuoglu et al., 2002; Evans & Foltin, 2006). Stress and cocaine each enhance brain~     stress circuits, namely the corticotrophin releasing factor~     (CRF)-hypothalamic-pituitary-adrenal (HPA) axis and central~     noradrenergic/sympatho-adrenomedullary (SAM) pathways and both activate the mesolimbic~     dopaminergic systems involved in the rewarding effects of cocaine (ADD REFS). Exposure to~     Stress, cocaine or cocaine cues will each increase cocaine craving and HPA axis responses.~     Importantly, progesterone which affects behavioral responses to cocaine, also plays a key~     role in stress regulation. However, it is not known whether progesterone alters~     stress-induced and drug cue-induced craving and related stress arousal, markers that predict~     cocaine relapse outcomes. Our preliminary data suggest that women exposed to stress and to~     drug cues in the laboratory during the luteal phase (high progesterone) show lower stress~     induced and drug cue-induced craving, anxiety and cortisol responses compared to those in the~     late follicular phase (high estrogen) (see preliminary Studies section CX). On the basis of~     this previous research, we propose a double-blind placebo controlled study of to examine~     progesterone's effects on stress and cue-related responses in cocaine dependent men and~     women. We hypothesize that high dose of progesterone (200 mg bid) vs. placebo will alter~     stress-induced cocaine craving, negative affect, physiological and HPA responses to stress,~     and these changes will be greater in women than men.~   "
227055|NCT00585507|"~     Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic~     breast cancer. The dose used in studies so far has been well tolerated and may be too low for~     optimal effectiveness. In this study, a higher dose will be used to see whether an improved~     outcome will result.~   "
227056|NCT00585494|"~     This protocol will determine the prevalence of hyperglycemia and diabetes in the elective~     orthopedic population at the University of Wisconsin. It will also determine if there is a~     difference in outcomes. The study hypothesizes that at least 10% of patients will have some~     degree of impaired glucose regulation that has previously been undiagnosed.~   "
227057|NCT00585481|"~     The primary objective of this study is to determine the incidence of severe RSV LRTI~     requiring hospitalization among infants born < 35 weeks gestational age for one year of~     follow-up.~   "
227058|NCT00585468|"~     Literature regarding the effect of food on the pharmacokinetic (PK) profile of enteric-coated~     mycophenolate sodium combined with tacrolimus and corticosteroid withdrawal is lacking. The~     objective of this study is to identify pharmacokinetic variables of mycophenolate sodium~     (Myfortic®) in the fed and fasting state in stable renal transplant patients on tacrolimus in~     combination with a rapid steroid withdrawal protocol.~   "
227059|NCT00585455|"~     To determine the effects of chronic sertraline treatment on brachial artery flow-mediated~     dilation in patients with chronic heart failure and depression~   "
227060|NCT00585442|"~     The cardiovascular effects of vitamin D therapy (in humans) have been documented only in~     patients with known vitamin D deficiency or hyperparathyroidism (a surrogate marker of~     inadequate vitamin D activity). It is unknown whether the cardiovascular benefits of vitamin~     D therapy extend beyond these patients to the general hypertensive population. We propose to~     directly measure the effect of vitamin D therapy on plasma renin activity (PRA), plasma renin~     concentration (PRC), renin transcription (in mononuclear leukocytes), and blood pressure in~     hypertensive (but otherwise healthy) patients in a randomized, controlled, experimental~     trial. This will be the first study to assess vitamin D receptor (VDR) biological (PRA, PRC,~     renin mRNA, and polymorphisms) and hypertensive activity in patients without vitamin D~     deficiency. We hypothesize that vitamin D inhibition of renin transcription will produce~     significant reductions in PRA, PRC, renin transcription, inflammatory cytokines, SBP, and~     DBP, with potential variation by VDR genotype. Such a result may prove to be significant in~     the treatment of hypertension, as even modest blood pressure reductions (5 mmHg) are~     associated with a 14% reduction in mortality due to stroke, a 9% reduction in mortality due~     to CHD, and a 7% overall reduction in all-cause mortality.~   "
227061|NCT00585429|"~     A non-invasive urinary test that detects kidney injuries in liver transplant (LT) candidates~     would be useful for monitoring of kidney damage. Particularly, the ability to predict~     irreversibility of such renal damage or progressive nature of renal disease in LT candidates~     would be of importance to determine the need for dual kidney-liver transplantation (KLT)~     versus LT alone. We will correlate kidney histology with cytokine/chemokine profile~     expression in the urine as a potentially useful noninvasive diagnostic tool.~   "
227062|NCT00585416|"~     The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with~     metastatic hormone refractory prostate cancer as measured by changes in PSA.~   "
227063|NCT00585403|"~     The goal of this research is to determine how the peripheral immune system is altered by~     exercise and differences related to gender, pubertal status and health.~   "
227064|NCT00585390|"~     The purpose of this research study is to find out what effects (good and bad) that omega-3~     fatty acids has on schizophrenia.~   "
227065|NCT00585377|"~     In an attempt to improve the therapeutic index for initial therapy of metastatic NSCLC, the~     combination of bevacizumab and erlotinib is being proposed as first-line treatment in place~     of conventional chemotherapy. This trial is intended to provide pilot data for a future~     randomized trial of this combination of targeted agents versus conventional chemotherapy for~     advanced NSCLC.~   "
227066|NCT00585364|"~     The goal of this study is to identify the immunological factors that influence a patient's~     response to the presence of the fungus Aspergillus fumigatus (A. fumigatus) in the lungs. In~     patients with cystic fibrosis (CF), this fungus is not known to cause damage to the lungs,~     but some patients respond with an allergic reaction that may cause wheeze, cough, or~     difficulty breathing. Approximately 230 patients will be enrolled with an additional 60~     people who do not have CF and who do not have a history of asthma to serve as a comparison~     group.~   "
227112|NCT00584753|"~     This study is a feasibility study to determine if a combined breast PET/CT scanner can image~     malignant functional activity while determining anatomical structure in the same clinical~     setting for patients with breast cancer. End-points of this study are whether women will~     accept the imaging position and timing, and whether functional properties of breast cancer~     can be imaged with this device. The secondary purpose of this study is to explore protocol~     parameters with a view to optimizing imaging performance whilst minimizing patient~     discomfort. Imaging results will be compared to histological samples to determine ground~     truth.~   "
227067|NCT00585351|"~     We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and~     are being transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics~     (UIHC) for further care to participate in this research study to test the following: 1) To~     test whether it is possible to go through all the procedures necessary to start a study,~     including an informed consent, before the patient is transferred by helicopter to Iowa City.~     2)To test a low risk medication called, Ranitidine, that might lower the chances of~     developing chemical pneumonitis (irritation of the lungs by stomach contents), a fairly~     common complication in patients that have had a stroke. Patients will be randomly assigned to~     receive a single dose injection of either Ranitidine (50 milligrams (mg)) or placebo (normal~     saline).~   "
227068|NCT00585338|"~     Dermatologists have for many years treated vascular lesions by a variety of modalities~     including cryosurgery, electrotherapy, dermabrasion and radiation.~      It has been hypothesized that simultaneous delivery of these two wavelengths may provide~     safer, and in some cases more effective, vascular lesion removal.~      The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple~     532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of~     long-term side effects.~   "
227069|NCT00585325|"~     Patients will be randomized prospectively to one of two groups. One group will receive 5~     mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC~     sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool~     prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1~     hour after the procedure. Pain scores will then be compared between the lidocaine and placebo~     groups.~      Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity~     thresholds in an adult.~   "
227070|NCT00585312|"~     To test whether celecoxib can be used to prevent colon polyp formation in children with~     familial adenomatous polyposis (FAP).~   "
227071|NCT00585299|"~     To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will~     lead to improvements in insulin sensitivity, which will be associated with changes in both~     glucose status and lipid profiles, in obese children and adolescents with fatty liver who~     have normal glucose or pre-diabetes.~   "
227072|NCT00585286|"~     The purpose of this research study is to evaluate the safety and effectiveness of a new~     investigational laser device for treatment of acne scarring, for improvement in the~     appearance of surface texture and topography (recessed or uneven surfaces).~   "
227073|NCT00585273|"~     Over the last decade, second generation antipsychotics have been increasingly utilized. Since~     their introduction, however, atypical antipsychotics have been increasingly associated with~     significant metabolic complications including hyperlipidemia, insulin resistance/diabetes~     mellitus, and obesity. These metabolic complications increase the risk for cardiovascular~     disease in populations with an already elevated risk.~      The initial goal of the proposed study is to identify early signs of endothelial dysfunction~     and vascular disease in those treated with atypical antipsychotics. The identification of~     early signs of vascular disease may further link metabolic complications with any~     cardiovascular risk. Demonstration of changes in vascular function associated with atypical~     antipsychotics represents an important identifiable intermediate of more long-term~     cardiovascular risk.~      The second goal of the proposed study is to identify genetic factors that may be associated~     with the development of cardiovascular disease, which can later serve as a guide to predict~     risk. Accurate prediction of risk may facilitate the future development of an empirical,~     risk-based, individualized selection process for antipsychotic medications.~      Aim 1: To quantify the role of antipsychotic-induced metabolic complications on the~     development of vascular disease using measures of endothelial function.~      Hypothesis 1: Atypical antipsychotics will lead to greater impairments in endothelial~     function, evidenced by decreased flow-mediated dilation from baseline measures and compared~     with changes over time in controls. Medication-induced metabolic complications will be~     temporally associated with these impairments in endothelial function.~      Aim 2: To investigate the role of candidate pharmacogenetic polymorphisms with cardiovascular~     and metabolic complications of atypical antipsychotics.~      Hypothesis 2: Profiles of polymorphisms at receptors targeted by atypical antipsychotics will~     be associated with impaired cardiovascular function and metabolic complications.~   "
227074|NCT00585260|"~     The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can~     safely characterize asthma phenotypes, predict asthma control and exacerbations, predict~     responses to interventions, and perform more specifically than a direct methacholine~     challenge and; 2) PX27 pore function in whole blood correlates with measures of airway~     hyperresponsiveness induced by methacholine and/or mannitol challenges~   "
227075|NCT00585247|"~     Port wine stains are red birthmarks that without treatment persist for a lifetime. They are~     frequently found on the face and can be conspicuous and disfiguring, negatively impacting~     social interactions for these patients. Treating Port wine stains is difficult. The standard~     of care is to use laser treatment, but over 80% of patients fail to completely clear despite~     multiple treatments. The growth of additional blood vessels (angiogenesis) following the~     Laser treatment is likely an important factor in why these lesions persist despite therapy.~   "
227076|NCT00585234|"~     This project seeks to develop a standardized technique for simultaneous capturing bi-planar~     images of patients against a standard background with a grid that can be used later for the~     quantitative determination of global balance and thoracic symmetry.~      We hypothesize that patients who are successfully managed with surgery will demonstrate an~     improvement in global balance and thoracic symmetry that can be accurately measured. This~     measurement station will be specifically developed to provide a standardized, reproducible~     means to compare clinical assessments of surgical and non-surgical outcomes, and establish~     normative data for comparison. This standardized tool can be established at multiple centers~     for use in multicenter trials.~   "
227077|NCT00585221|"~     Imatinib (IM) has dramatically improved survival of gastrointestinal stromal tumors (GIST).~     However, most patients become resistant to IM in less than two years. This clinical trial~     combines targeted therapy (IM) with immunotherapy (peginterferon α-2b). Hypothesis:~     Apoptosis/necrosis of imatinib-sensitive GIST releases GIST-specific antigens in vivo while~     Peginterferon α-2b fulfills the role of cytokine signal (danger signal), this combination can~     induce effective innate and adaptive anti-GIST immunity, which can eradicate~     imatinib-resistant clones and GIST stem cells via recognition of common antigens shared with~     imatinib-sensitive GIST, leading to improved response rate and remission duration.~   "
227078|NCT00585208|"~     The purpose of this research study is to evaluate the safety and efficacy of ramelteon~     (Rozerem™) as an add-on treatment for sleep problems in patients with bipolar disorder. This~     study will determine whether or not the addition of ramelteon to ongoing medication(s) for~     bipolar disorder is useful in improving sleep.~   "
227079|NCT00585195|"~     PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor~     cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor~     tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma~     kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is~     the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.~   "
227080|NCT00585182|"~     Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients.~     Consensus guidelines recommend using medications such as heparin or low-molecular-weight~     heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a~     fixed dose that is the same for everyone. The appropriate dose of medication in patients with~     severe obesity is uncertain. There is some evidence that the use of standard fixed-doses in~     severely obese patients may not provide adequate protection against DVT. The purpose of this~     study is to evaluate a weight-based dose(0.5 milligrams per kilogram of body weight) of the~     commonly prescribed LMWH, enoxaparin in severely obese patients to determine if predictable~     levels of blood thinning can be achieved. We hypothesize that dosing enoxaparin 0.5mg/kg once~     daily in severely obese patients will lead to predictable blood levels.~   "
227081|NCT00585169|"~     The goal of the proposed study is to evaluate the efficacy and safety of the drug memantine~     in individuals with pathological gambling (PG). Thirty subjects with DSM-IV PG will receive~     10 weeks of open-label treatment with memantine. The hypothesis to be tested is that~     memantine will be effective and well tolerated in patients with PG. We hypothesize that~     memantine will reduce the severity of gambling symptoms and improve patients' overall~     functioning. This study will provide needed data on the treatment of a disabling disorder~     that currently lacks a clearly effective treatment.~   "
227082|NCT00585156|"~     The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous~     coated implants, following postoperative total knee arthroplasty administration of Celebrex~     for pain relief.~   "
227083|NCT00585143|"~     Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the~     Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly~   "
227084|NCT00585117|"~     Hypoxia is a key factor in malignant progression of a neoplasm. It is our aim to explore the~     basis for quantitative in vivo tumor imaging by Cu-61~     diacetyl-bis(N4-methylthiosemicarbazone)PET imaging as a surrogate of tissue hypoxia. We~     hypothesize that the hypoxia levels are predictive of the tumor response to therapy. Patients~     will have 2 CU-ATSM PET scans done and the goal is to show spatially stable tracer~     distributions that correlate with tumor hypoxia. This study will serve as a pilot study for a~     PO1 submission~   "
227085|NCT00585104|"~     This study will test the hypothesis that mechanical efficiency as measured by pressure-volume~     loop assessment should improve during short-term treatment with intravenous levosimendan.~      Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which~     has been shown to have beneficial hemodynamic effects in patients with decompensated~     congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to~     troponin C. This agent is approved in Europe for treatment of heart failure patients. In the~     United States, this agent is currently under phase III investigation for intravenous~     treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal~     activity. Levosimendan has been studied in these patients with acute HF and is considered~     experimental in the United States for this population.~   "
227086|NCT00585091|"~     There is now strong evidence from clinical trials that carvedilol therapy in heart failure is~     superior to therapy with metoprolol. Not only does carvedilol have superior effects on lipid~     profiles, insulin sensitivity, renal blood flow, and reversal of pathologic remodeling but~     also its use is associated with fewer deaths compared to metoprolol. These facts make it~     important to carefully define how metoprolol and carvedilol are pharmacologically different.~     One potential difference is α1-AR antagonism. If we demonstrate that these α1-AR effects are~     preserved with chronic therapy, then α1-AR blockade may have an important role in carvedilol~     favorably altering the natural history of heart failure. On the other hand, if we demonstrate~     that tolerance to the α1-AR blockade effect of carvedilol decreases with time, then it would~     be unlikely that this pharmacologic property contributes to the efficacy of carvedilol. In~     such a case other pharmacologic properties, such as antioxidant activity, would appear to be~     important. These results will help guide future studies into CHF and AR blockade.~   "
227087|NCT00585078|"~     There are limited treatment options available for patients with advanced pancreatic ductal~     adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety~     of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced~     and metastatic PDAC treated in the first and second lines.~   "
227088|NCT00585065|"~     To collect information on pediatric patients receiving Cardiac Resynchronization Therapy~     (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart~     failure.~   "
227089|NCT00585052|"~     The purpose of this study is to find out if the treatment combination of paclitaxel and~     lovastatin is more effective than the currently available chemotherapy for refractory or~     relapsed ovarian cancer. This research is being done to improve on currently available~     chemotherapy for ovarian cancer.~   "
227090|NCT00585039|"~     The purpose of this study is to determine in a large, double-blind, randomized, prospective~     pediatric clinical trial whether the use of continuous levalbuterol (Xopenex) in addition to~     standard emergency department treatment for acute asthma exacerbations will improve the~     Forced Expiratory Volume in 1 sec (FEV 1) compared to the use of continuous racemic~     albuterol. The secondary objective is to correlate clinical (hospitalization rates and~     clinical asthma scores) with plasma levels of (S)-albuterol.~   "
227091|NCT00585026|"~     This is a research study designed to test the utility of D-shaped bifocal lenses and PRIO~     Computer Lenses for persons using a computer. We hypothesize that lenses specially designed~     for computer use may allow more comfortable and productive work on a computer.~   "
227113|NCT00584740|"~     This study will assess the safety and efficacy of AIN457 in patients with moderate to severe~     active Crohn's disease.~   "
227114|NCT00584727|"~     The purpose of this study is to determine the relative performance of a new toric soft~     contact lens against a toric and a spherical contact lens currently available in market,~     specifically with regards to the fit and visual acuity as well as the comfort, vision and~     satisfaction while in the practitioner's office. Approximately 2 hours duration.~   "
227115|NCT00584714|"~     The purpose of this study is to collect longer term follow-up information concerning health~     and survival on selected patients who received PB127 for injectable suspension in the pivotal~     trial (127-014).~   "
245574|NCT00339183|"~     The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI~     compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.~   "
227092|NCT00585013|"~     Each year, there are over 400,000 cardiac surgical operations performed in the United States;~     of which 10,000 are performed on children. These operations are made possible by the use of~     the heart-lung bypass machine, also known as cardiopulmonary bypass. This machine allows for~     the body to be supported while the heart is repaired. While this machine has been life~     saving, it has risks and can lead to a variety of complications.~      One such complication results from the fact that the patient's blood is exposed to the~     foreign material of the machine, such as plastic tubing. In nearly all cases of cardiac~     surgery, this leads to a whole body response in the patient following the operation. This~     response, inflammation, is characterized by alterations in the function of the heart and~     lungs, fever, fluid retention, and bleeding disorders in the postoperative period. While this~     is usually temporary and self limiting, significant morbidity occurs in approximately 1-2% of~     cases where this inflammatory response is present. Additionally, children appear to be more~     susceptible to this response. This can lead to significant postoperative complications that~     are not associated with the actually surgical procedure performed on the heart.~      The exact cause of this response is not fully understood. However, it is important to~     understand the triggers, timing, and pattern of this complex inflammatory response in order~     to modify or arrest it. Unlike other situations associated with this type of whole-body~     inflammatory reaction such as trauma or overwhelming infection, cardiac surgical teams have~     the advantage of knowing when the trigger will occur (i.e. during the cardiac operation) and~     hence have the opportunity for preemptive intervention in an effort to minimize the response.~     One such effort is the focus of this proposal.~      Nitric oxide (NO) is a gas that has been used for years in the treatment of lung disease in~     infants. It has been life saving and safe. Recently, it has been investigated for its~     anti-inflammatory effects outside the lungs. We propose delivering NO to the source of the~     greatest inflammation in cardiac surgery, the cardiopulmonary bypass machine. It is our~     intention to show that in doing so; we can minimize the inflammation found in the first 24~     hours following cardiac surgery in children. If we are correct, the reduction of this~     inflammation will result in less damage to other organs of the child's body and improved~     outcome following surgery.~   "
227093|NCT00585000|"~     This will show if CP-675,206 can be administered safely as an intravenous infusion lasting~     one hour. CP 675,206 already has been administered to 835 subjects over 1.0 - 7.5 hours.~   "
227094|NCT00584987|"~     We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis~     medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to~     faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of~     fluticasone furoate alone.~   "
227095|NCT00584974|"~     To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major~     Depressive Disorder~   "
227096|NCT00584961|"~     To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II~     Disorder.~      To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12~     months using the assessment of the symptoms disease and the progress of metabolic and~     cardiovascular risk.~      To analyse the health status, quality of life and functioning/disability of patients.~   "
227097|NCT00584948|"~     The purpose of this study is to determine if memantine is effective in treating symptoms of~     Fragile X-associated Tremor Ataxia Syndrome.~   "
227098|NCT00584935|"~     Cicatricial pemphigoid is an autoimmune blistering disease which affects the skin, mucous~     membranes, and, in a small subset of patients, the eye. Progressive ocular disease can lead~     to irreversible damage and blindness. Conventional treatments include systemic steroids,~     dapsone, and immunosuppressive agents. These treatments, however, are not successful with all~     patients. Rituximab has been very effective in the treatment of other autoimmune disorders,~     and has recently been shown to be effective for autoimmune blistering pemphigus. We propose~     that it will also be effective in the treatment of cicatricial pemphigoid.~   "
227099|NCT00584922|"~     The purpose of this study is to prospectively follow the next 200 patients who undergo~     catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.~   "
227100|NCT00584909|"~     The main purpose of this study us to determine the best treatment for patients with~     endometrial cancer who are at an elevated risk for recurrence.~   "
227101|NCT00584896|"~     The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists~     in the diagnosis or exclusion of coronary artery disease.~   "
227102|NCT00584883|"~     To determine the maximum tolerated dose of ABT 510 when administered concurrent with~     radiation therapy for patients with newly diagnosed glioblastoma multiforme.~   "
227103|NCT00584870|"~     The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared~     with placebo and compared with naproxen in the treatment of adult patients with chronic low~     back pain.~   "
227104|NCT00584857|"~     This is a study to determine the optimal treatment for patients with advanced stage or~     recurrent endometrial cancer. Traditionally, patients have been treated with either hormonal~     therapies (megesterol) or chemotherapy (paclitaxel and carboplatin). This study investigates~     the effectiveness of the combination of hormonal therapy and chemotherapy. This study also~     will examine the side-effects associated with these drugs and the quality of life of patients~     on combination therapy.~   "
227105|NCT00584844|"~     This study is designed to determine the safety and immunogenicity of a Live Francisella~     tularensis Vaccine~   "
227106|NCT00584831|"~     The relative performance of a new toric soft contact lens against toric contact lenses~     currently available in market, specifically for visual acuity and lens orientation. The study~     will be conducted in a staged approach (2 stages).~   "
227107|NCT00584818|"~     The purpose of this study is to determine the dose of PB127 for detection and/or exclusion of~     coronary artery disease when used with cardiac ultrasound. This study also evaluates the~     safety of PB127.~   "
227108|NCT00584805|"~     This study is designed to determine the safety and immunogenicity of Eastern Equine~     Encephalitis (EEE) Vaccine.~   "
227109|NCT00584792|"~     This is a single center pilot study to asses the feasibility of conducting a larger~     population-based study. It is an investigator-initiated study funded yb the UC Davis Cancer~     Center's Development Award Program. The hypothesis is that the percent african ancestry in an~     individual may determine their prognosis if diagnosed with prostate cancer.~   "
227110|NCT00584779|"~     To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects~     with renal impairment, compare the results to Western study results and confirm the adaptive~     possibility of dose adjustment in US package insert to Japanese.~   "
227111|NCT00584766|"~     To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous~     bone marrow transplantation after initial tumor cytoreduction for patients with~     receptor-negative metastatic breast carcinoma and to determine the optimal timing of~     CyBCNU-ABMT after initial development of metastatic breast carcinoma~   "
227127|NCT00584558|"~     The purpose of this study is to assess the long-term effects of catheter ablation procedures~     performed at the OU Medical Center.~   "
227128|NCT00584545|"~     To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on~     fluoroscopy by comparing it with simultaneous pharyngeal manometry.~   "
227116|NCT00584701|"~     Autism is a complex neurodevelopmental disorder that is thought to involve an interaction~     between multiple and variable susceptibility genes, environmental factors, and epigenetic~     effects. Great concern has been raised about the marked increase in the prevalence of autism~     spectrum disorders in the last decade. Risperidone, the most studied atypical antipsychotic~     used in children, has been shown to improve severe behavioral difficulties in over half of~     children with autism who have these difficulties. However, not all children with autism and~     severe behavioral problems respond to risperidone, and for a few, it has significant side~     effects.~      Two controlled studies and numerous open-label and long term studies in children with autism~     spectrum disorders using the atypical antipsychotic risperidone show a significant decrease~     of associated serious behavioral problems. The use of atypical antipsychotics is of great~     concern, however, because of their significant side effects and the fact that only two-thirds~     of children positively respond. Ways to predict response, appropriate dosage and serious side~     effects are needed.~   "
227117|NCT00584688|"~     Research studies raise the possibility that medications such as quetiapine may improve mood~     or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite.~     The medication quetiapine also known as seroquel works by activating certain systems in the~     brain, such as ones known as dopamine and serotonin chemical systems in the brain.~   "
227118|NCT00584675|"~     Involves a 24-hour pH probe study using the Dx-pH Measurement System on patients who do not~     have symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease to establish~     normal values for the Dx-pH Measurement System.~   "
227119|NCT00584662|"~     Nasal glucocorticosteroids (GCS) are considered first-line therapy for both allergic and~     non-allergic rhinitis.1-3 Nasal congestion can persist despite maximum treatment with~     intranasal GCS. No other drugs are superior to intranasal GCS in relieving nasal congestion.~     For example, antihistamines are not effective in relieving congestion.1 Oral decongestants~     are somewhat beneficial in relieving nasal congestion but can elevate blood pressure, cause~     restlessness, and cause urinary retention. Oxymetazoline, however, is a potent decongestant~     and the addition of it to a nasal GCS should add a considerable decongestant benefit. It may~     also be beneficial in patients with persistent nighttime congestion despite maximum dosages~     of nasal GCS.~      Oxymetazoline is currently recommended for three days use because of the proposed risk of~     rhinitis medicamentosa,4 which is increased nasal congestion caused by prolonged use of nasal~     decongestant sprays.5-8 The term RM was coined early in the twentieth century after several~     case reports described patients developing rebound congestion after using first generation~     intranasal decongestants such as privine hydrochloride and ephedrine for prolonged~     periods6,7. The histopathology and mechanism of RM has been based on animal models which may~     not be pertinent to humans.9-13 Studies using oxymetazoline, a newer intranasal decongestant,~     in individuals without rhinitis have shown conflicting evidence for the development of~     RM.14-16 For example, normal individuals without rhinitis using oxymetazoline three times~     daily for four weeks did not develop RM.17 Also, it is unknown the frequency of~     administration and dosage of oxymetazoline it takes to induce RM or whether RM is just a~     return to a patient's baseline nasal congestion as present before beginning oxymetazoline. It~     is also unknown whether RM is more likely or only occurs with older vasoconstrictors such as~     privine hydrochloride and ephedrine rather than oxymetazoline.~      Nasal GCS reduce the amount of rebound congestion in patients with perennial allergic~     rhinitis who have reportedly developed RM.18 Nasal GCS decrease nasal mucosa edema,~     recruitment of neutrophils and mononuclear cells, cytokine production, and late-phase nasal~     mediators.19-21 They may offer a protective benefit from the risk of developing RM.~     Oxymetazoline may also decrease inferior turbinate hypertrophy thereby permitting better~     adsorption of the nasal GCS.~      Hypothesis~      The addition of oxymetazoline to a nasal GCS for fourteen days will decrease the amount of~     congestion in subjects with allergic or non-allergic rhinitis with persistent congestion~     despite maximum recommended dosages of a nasal GCS. It is also hypothesized that nasal GCS~     protect against the development of RM secondary to oxymetazoline.~   "
227120|NCT00584649|"~     Hypothesis- Radiofrequency ablation, targeting the sympathetic input of the sinus node~     identified by 20Hz stimulation at the junction of the superior vena cava and the right~     atrium, will effectively reduce sinus rate acutely and will reduce palpitations due to~     inappropriate sinus tachycardia without the need for pacemaker implantation due to sinus node~     dysfunction post ablation.~   "
227121|NCT00584636|"~     The purpose of this study is to see if the addition of budesonide to oral corticosteroids~     will result in a decrease in relapse rates compared to oral corticosteroids alone in children~     who are discharged from the ED after an asthma exacerbation. Secondly, that there will be an~     improvement in lung function, a decrease in beta-2 agonist use and an improvement in~     health-related quality of life compared to placebo.~   "
227122|NCT00584623|"~     To correlate findings between two commonly-used types of swallowing studies: videofluoroscopy~     and flexible endoscopic evaluation of swallowing (FEES).~   "
227123|NCT00584610|"~     This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing~     intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) on coagulation~     parameters known to be associated with risk of thrombosis (blood clots). Both the LNG IUD and~     the copper IUD are FDA approved devices for contraception.~      Women enrolled in this study will be randomized to receive either the LNG IUD or the copper~     IUD. They will complete a one month bleeding diary prior to insertion of the IUD and again~     for one month while the IUD is in place. They will undergo phlebotomy (blood draw) at~     baseline (prior to insertion of the IUD), two and four months. Stored samples will be used to~     measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIIIc, activated partial~     thromboplastin time (aPTT) and activated partial thromboplastin time plus activated protein C~     (aPTT + APC). Both groups will undergo a GYN exam with screening for bacterial vaginosis and~     gonorrhea/chlamydia cultures prior to insertion of the IUD. A brief survey to assess the~     women's experience with the IUD, including symptomatology and satisfaction with the device,~     will be conducted at the four months after insertion.~   "
227124|NCT00584597|"~     The specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in~     head and neck cancer patients undergoing radiation therapy.~   "
227125|NCT00584584|"~     This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal~     antibody) gives protection against a model of hayfever~   "
227126|NCT00584571|"~     Constipation is a common digestive disorder. After excluding dietary factors, drugs and other~     secondary causes, at least three broad pathophysiologic subtypes are recognized- dyssynergic~     defecation, constipation-predominant irritable bowel syndrome (IBS-C) and slow transit~     constipation (STC), all predominantly affect women and elderly. Many patients also~     demonstrate abnormal rectal perception with both rectal hyposensitivity and hypersensitivity~     being common. Recent surveys show that most constipated patients are dissatisfied with~     current therapy. Also, constipated patients showed significant psychological dysfunction and~     impaired quality of life. OBJECTIVE: To investigate a novel biofeedback technique of~     improving rectal hypersensitivity.~      METHODS: A large compliant balloon attached to a barostat was placed in the rectum in 8~     patients with rectal hypersensitivity (urgency/pain threshold <30 mm Hg). Sensory~     deconditioning was performed by incremental balloon distensions (1-2 mmHg) until normal~     thresholds were reached.~   "
227133|NCT00584480|"~     The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen~     Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of~     this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to~     measure the effect of HBOT on specific chemicals in their blood that may play a role in the~     child's behavior.~   "
227134|NCT00584467|"~     This is an investigator initiated registry aimed at assembling a blood/serum and genomic~     resource (bank) of human blood samples with accompanying clinical data mainly from patients~     who are scheduled to undergo cardiac catheterization at UC Davis Medical Center, but may also~     include other eligible individuals. Funding is from institutional/divisional research funds.~   "
227135|NCT00584454|"~     The purpose of this study is to evaluate the safety of Q Fever vaccine, NDBR 105, and collect~     data on incidence of occupational Q Fever infection in at risk personnel.~   "
227136|NCT00584441|"~     Asthma is a chronic inflammatory lung disease characterized by airway hyper-responsiveness~     and reversible airway obstruction. Over the last decade, the prevalence of asthma is on the~     rise and it disproportionately affects more women than men. As much as 40% of women with~     asthma are known to have worsening of asthma symptoms and lung function prior to~     menstruation. This syndrome is being increasingly recognized as premenstrual asthma (PMA).~     The pathologic differences in female asthmatics with and without this syndrome are not known.~     The evidence regarding the role of sex hormones has been contradicting. We propose an~     observational cohort study to examine the changes in airway inflammation in women with asthma~     in relation to their menstrual cycle and their association with sex hormone levels. In~     addition we will include women on oral contraceptives to determine their effect on airway~     inflammation and asthma symptoms.~      We hypothesis that:~        -  Women with premenstrual asthma will show increased indices of airway inflammation in~          various phases the monthly menstrual cycle.~        -  In women with premenstrual asthma, a change in serum estradiol/progesterone ratio during~          the late luteal phase is associated with worsening of airway inflammation, air flow~          limitation and asthma symptoms.~        -  The use of oral contraceptives is associated with suppression of the cyclical changes in~          airway inflammation due to lack of fluctuations in estradiol and progesterone levels.~      Recruited subjects will be asked to record asthma symptom scores, morning Peak Expiratory~     Flow Rate (m-PEFR) and rescue asthma medication (β2-agonist) used daily during the one month~     screening period to identify women with and without pre-menstrual asthma. Asthmatic women~     with regular menstrual cycles will be evaluated in their follicular phase (days 5-8) and~     luteal phase (days 21-24) and women on oral contraceptive pills (OCP) will be evaluated on~     days 9-12 of their OCP cycle and during the days 25-28, off of OCP consecutively for a~     2-month period.~   "
227137|NCT00584428|"~     To evaluate the response rate and the response duration of high dose chemotherapy with~     autologous bone marrow transplantation as intensification following induction chemotherapy in~     metastatic breast cancer and to evaluate prospectively the subdivision of patients with~     metastatic breast cancer according to prognostic groups.~   "
227138|NCT00584415|"~     The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be~     used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation~     in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial~     fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.~   "
227139|NCT00584402|"~     The purpose of this study is to determine the efficacy of the Definity (perflutren lipid~     microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors~     (hepatomas & metastases) within the liver.~      Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with~     contrast-enhanced sonography~      Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the~     conspicuity of small tumors on contrast-enhanced sonography~   "
227140|NCT00584389|"~     This study will determine in obese subjects the direct effects of the weight loss drug~     rimonabant (ie independent of weight loss) on energy expenditure, fat metabolism and and body~     fat distribution. We hypothesise that rimonabant will increase energy expenditure. The fuel~     for the increased energy expenditure will come from fat. As a result of burning more fat~     there will be a decrease in fat in blood and an improvement in the body's response to~     insulin.~   "
227141|NCT00584376|"~     This will be a multi-site, prospective, double-blind, randomized, placebo-controlled,~     crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to~     treat symptoms of ET.~   "
227142|NCT00584363|"~     The purpose of the study is to collect pancreatic tissue, blood and urine from adults to~     study pancreatic abnormalities.~   "
227143|NCT00584350|"~     The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation~     with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic~     coronary angiogram or to PCI.~   "
227144|NCT00584337|"~     This study is designed to evaluate a new approach to the diagnosis of chronic or sub-acute~     chest pain patients in the out-patient setting. Patients in this study are selected to be~     low-risk, meaning they are not having an acute or recent heart attack (AMI), based on~     screening blood tests and electrocardiograms (EKGs). In addition, these patients have a low~     or intermediate pre-test likelihood of the coronary artery disease (CAD), which means that~     probability of the CAD based on the available clinical and historical information, does not~     make a diagnosis of the CAD a certain clinical diagnosis in the particular patient and this,~     in turn, requires an additional diagnostic work up.~   "
227145|NCT00584324|"~     Purpose of this study is to see if different levels of anesthesia have an effect on hearing~     spoken words without awareness of having heard them or anxiety after surgery.~   "
227146|NCT00584311|"~     Radiographic imaging plays a key role in managing the long-term effects of hyperuricemia on~     the skeletal system. Two of the accepted indications for prophylactic urate-lowering drugs in~     patients with hyperuricemia are gouty tophi and erosions. While much data exist on the plain~     radiographic changes that are seen in patients with chronic gout, far less is known about the~     changes seen on other imaging modalities, such as magnetic resonance imaging (MRI) and~     ultrasound (US). Further, there is very little data on the MRI and US appearance of~     asymptomatic joints in patients with hyperuricemia and symptomatic gout.~      There is vast emerging data to suggest that MRI and US are much more sensitive than plain~     radiographs at detecting the early stigmata of rheumatoid arthritis (RA). Indeed, these~     imaging devices have revolutionized the treatment of RA, for the earlier detection of the~     skeletal changes of RA often mandates more aggressive therapy. These same changes would often~     be missed by plain radiographs.~      It is our hypothesis that MR imaging and US will detect the skeletal changes that are typical~     of gout much sooner than would plain radiography. We also hypothesize that these same imaging~     techniques will be able to detect signs of hyperuricemic silent deposition in asymptomatic~     joints of patients with symptomatic gout in other joints. As was the case with RA, the~     expected results of this study would mandate more aggressive therapy of both gout and~     hyperuricemia.~      Our primary aim of this proposal would be accomplished by studying patients with known gout~     and normal plain radiographs. Each patient would have their most frequently involved joint~     (index joint) analyzed by MRI and US to evaluate for any destructive changes (erosions or~     tophi with cortical damage). Any signs that may portend future joint destruction such as~     synovial pannus, bone marrow edema, soft tissue edema, or joint effusions will also be~     documented. In order to demonstrate the effects of hyperuricemic silent deposition, an~     asymptomatic joint from these same patients will be studied using these same imaging~     techniques. Any evidence of erosions, tophi, synovial pannus, bone marrow or soft tissue~     edema, or joint effusions will be recorded. By demonstrating destructive, or potentially~     destructive, skeletal changes in the index joint or asymptomatic joint of a significant~     number of patients, we will show that patients who are left untreated on the basis of normal~     plain radiographs are likely to already have skeletal damage.~   "
227148|NCT00584285|"~     The objective of this study is to determine if corneal topography can be used to predict the~     fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be~     taken and the computer selected lens will be placed on the eye. After placement of the lens~     color photographs will be taken of the eye's fluorescein pattern and compared to the computer~     predicted pattern.~   "
227149|NCT00584272|"~     Investigator initiated retrospective chart review to study the effects of changing suture~     material on the healing and outcome of cleft palate surgery were.~   "
227150|NCT00584259|"~     Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.~   "
227151|NCT00584246|"~     This study will evaluate the safety and efficacy of Pregabalin (Lyrica) in treating patients~     with Restless Legs Syndrome (RLS) in a double-blind, placebo-controlled trial.~   "
227152|NCT00584233|"~     The investigators have studied the potential of breast computed tomography (bCT) for breast~     imaging under an NIH-funded Biomedical Research Partnership (BRP) grant (R01 EB002138-10),~     and 4 breast CT scanners have been developed that have imaged over 600 women to date (under~     more than one IRB-approved protocol). The BRP grant cannot be renewed, and with this~     (resubmitted) R01 grant application, the investigators seek to finalize the investigators'~     research in breast CT - The specific aims have been significantly modified as a result of the~     first critique, and the investigators now focus on a narrower set of remaining issues.~      This version of the protocol will add breast magnetic resonance imaging (MRI) to the~     experimental procedures.~   "
227153|NCT00584220|"~     The purpose of this study is to determine the relative performance of a new toric soft~     contact lens against a toric contact lens currently available in market, specifically with~     regards to the comfort and vision after two weeks of use.~   "
227154|NCT00584207|"~     This research study is being conducted to evaluate the safety and effectiveness of ablation~     (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by~     ultrasound. We are doing this to look for a less invasive method of treatment for patients~     with uterine fibroids. One method that is being used in other areas of the body to treat~     masses is radiofrequency electrocautery. This method may be performed for the treatment of~     uterine fibroids by placing a small diameter needle through the wall of the vagina into the~     fibroid guided by an ultrasound probe. An optional approach is to place the needle through~     the skin of the abdomen into the fibroid guided by an ultrasound probe. Once the needle is in~     the fibroid, the electrocautery current is applied and the fibroid is destroyed by heating.~     This would be done before hysterectomy (removal of the uterus). We are trying to test to see~     if this type of treatment can be applied to uterine fibroids. We are trying to develop~     radiofrequency electrocautery as one of the methods to treat fibroids without surgery.~   "
227155|NCT00584194|"~     This study is designed to determine the safety and immunogenicity of a Rift Valley Fever~     (RVF) Vaccine~   "
227156|NCT00584181|"~     Lung and heart-lung recipients at the University of Texas Medical Branch who have~     participated in the Assessment of Cough Reflex in Lung Transplant Recipients study who meet~     the specific study inclusion/exclusion criteria will have one study visit where they will~     undergo lung volume measurements, followed by high resolution CT scan of the lungs within 2~     hours. After the initial CT scan, patients will be given a standard dose of Atrovent,~     followed thirty minutes later by repeat lung volume measurements and CT scan.~   "
227157|NCT00584168|"~     This study looks at lessening the pain after a Uvulopalatopharyngoplasty (UPPP) surgery by~     using Dexamethasone (a corticosteroid).~   "
227158|NCT00584155|"~     The purpose of this study is to determine if Lactated Ringer's solution is effective in~     patients undergoing chemotherapy with cisplatin for head and neck cancer in regards to~     cisplatin-induced hearing loss.~   "
227159|NCT00584142|"~     The purpose of this study was two-fold: (i) to assess whether MBSR favorably influences~     psychological status, quality of life, stress hormones, and immune status in breast cancer~     survivors; and (ii) to explore possible mechanisms by which MBSR may favorably influence~     these outcomes, in particular, through reduction in fear of breast cancer recurrence and~     associated perceived stress. Both objectives were studied at the critical transition time~     immediately following completion of surgical, radiation and/or chemotherapy therapy for~     breast cancer.~   "
227160|NCT00584129|"~     The purpose of this project is to determine if pre-treatment swallowing exercises can improve~     post-treatment swallowing function in patients undergoing radiation with or without~     chemotherapy for advanced squamous cell carcinoma of the head and neck.~   "
227161|NCT00584116|"~     Prospective, two academic center, non-randomized pilot, acute in-patient study correlating~     pre-operative imaging studies, intra-operative measurements and intra-operative balloon~     aortic valvuloplasty (BAV) in patients with degenerative aortic stenosis undergoing surgical~     aortic valve replacement (SAVR) to understand the requirements (device size and radial~     strength) of emerging percutaneous heart valve technologies in the treatment of aortic~     stenosis.~   "
227162|NCT00584103|"~     The purpose of this study is to evaluate a design of prosthesis that is inexpensive and able~     to fit a multitude of individuals. This may offer an off the shelf item for those that cannot~     afford a customized prosthesis, or wish to have an inexpensive spare.~   "
227163|NCT00584090|"~     The primary purpose of this study is to measure the efficacy of solifenacin succinate~     (VESIcare) on treating urinary incontinence in Parkinson's disease patients.~      The secondary objective of this study is to examine the effect of solifenacin succinate~     (VESIcare) on symptoms of PD and the patient's quality of life.~   "
227164|NCT00584077|"~     The purpose of this study is to evaluate the presence of cough reflex in the transplanted~     lung of patients who have had either a single or double lung transplant or heart-lung~     transplant at University of Texas Medical Branch. At the 1 year post transplant bronchoscopy,~     the presence of the cough reflex will be assessed by placing 3 to 5 ml of 5% dextrose and~     placement of the bronchial biopsy forceps on teh airway mucosa. Three to four separate areas~     of the transplanted airways will be assessed. The cough reflex will be assessed by recording~     the surface electrical activity by placing external electrodes to monitor the movement of~     abdominal muscles during a cough. The data will be recorded and compared with recordings from~     coughs recorded using the surface electrical activity of a cough generated by non-transplant~     patients.~   "
227165|NCT00584064|"~     Emergency/compassionate use for the AMPLATZER PFO Occluder~   "
227166|NCT00584051|"~     Asthma is an inflammatory condition of the airways in the lungs that results in obstruction~     of airflow in those with the condition. The disease continues to be a major worldwide health~     care problem and its prevalence continues to increase annually. In 2005, 20 million people~     were diagnosed with asthma. The disease causes significant morbidity and accounts for 5,000~     deaths annually. Between 1980 and 1994 the prevalence of asthma increased 74% in the United~     States and, in children under age 5, the prevalence increased by 160%. The allergic etiology~     of airway inflammation associated with asthma is established. Bronchial washings of asthmatic~     subjects are most often characterized by eosinophils, mast cells, and cytokines that are~     associated with the Th2 (allergic) phenotype. Similarly, IgE plays a pivotal role in airway~     inflammation of asthmatic subjects when allergens that cross-link IgE bound to mast cells in~     the airways cause the release of histamine and other inflammatory mediators. The association~     of asthma and the IgE mediated allergic phenotype is well established and up to 70% of~     asthmatics also suffer from allergic disease.~      Adequately treated asthma often has minimal impact of quality of life but diagnosis and~     proper treatment is often delayed, resulting in increased missed school days, emergency room~     visits, and otherwise preventable degradation in quality of life. It would therefore be~     highly useful to identify a biomarker that can be used to assist in the diagnosis of asthma~     or to identify subjects at higher risk of developing allergic disease or asthma in the~     future. Efforts at identifying a genetic marker for the early diagnosis of asthma have been~     unsuccessful, mainly due to the complexity of the pathogenesis of the disease.~      Atrial natriuretic factor is a pro-hormone precursor for 4 natriuretic peptide hormones~     including atrial natriuretic peptide (ANP). ANP's effects on the cardiovascular system are~     well characterized. Less well understood is the role these hormones play in immune~     regulation.~      Recent studies have demonstrated a role for ANP in the regulation of immune function: ANP~     induces release of histamine from mast cells and macrophages, stimulates migration of~     neutrophils, enhances the cytotoxic activity of natural killer (NK) cells, and stimulates~     TNF-β production. Human dendritic cells express ANP receptors (GC-a) which polarize CD4+~     cells towards a Th2 phenotype.~      Since allergic rhinitis and asthma are associated with a Th2 phenotype, it is possible that~     elevated levels of ANP can be used to predict asthma severity or to predict future~     predilection to atopic disease.~      There are a number of ANP gene polymorphisms that have been studied and found to be~     associated with renal disease, heart disease, hypertension and diabetes. Several studies have~     investigated the potential role of these polymorphisms in cardiovascular disease and have~     found association between polymorphisms of the ANP gene and left ventricular remodeling,~     hypertension, renal disease, diabetes, and increased risk of ischemic stroke. To our~     knowledge, no studies evaluating the role of ANP polymorphisms in allergic disease have been~     performed.~      The goal of this research proposal is to evaluate whether ANP levels can be utilized to~     assist in diagnosis of asthma and in the prediction of asthma severity. Additionally, we will~     investigate the potential effect of polymorphisms in the ANP gene on asthma severity and thus~     serve as a useful genetic marker to predict future risk of atopy and asthma.~   "
227168|NCT00584025|"~     The primary purpose of this study is to characterize the acute anti-dyskinetic properties of~     intravenous levetiracetam in Parkinson's disease patients who have been optimized on~     antiparkinsonian medication. The secondary objective is to study the effect of intravenous~     LEV on additional motor and cognitive symptoms of PD.~   "
227169|NCT00584012|"~     This purpose of this study is to evaluate the use of two medications, docetaxel and~     lovastatin. There are two phases. Subjects in Phase I can have any cancer. This phase will~     determine the highest dose of lovastatin and docetaxel that can be given safely as well as~     the safety of combining the two drugs and the effect on the subject's tumor. Phase II will~     administer lovastatin and docetaxel only to subjects who have breast cancer tumors.~   "
227170|NCT00583999|"~     NAFLD is a spectrum of liver diseases associated with varying degrees of hepatic steatosis,~     inflammation, and in some cases, fibrosis. NAFLD is a common observation in all demographics,~     but the prevalence of NAFLD and nonalcoholic steatohepatitis (NASH) is especially high in the~     morbidly obese population. Leptin is a cytokine that is encoded by the ob gene and primarily~     secreted by adipose tissue. The production of serum leptin increases with progressive~     obesity. Because of this observation, there has been significant interest in potential role~     of leptin in NAFLD.~      Our hypothesis is that we will find increased hepatic leptin and leptin receptor expression~     as the degree of hepatic injury worsens in NAFLD.~   "
227171|NCT00583986|"~     This is a study to investigate the reliability, ruggedness and safety of the top mounted~     actuation indicator (TMAI) when used with Levalbuterol HFA MDI.~   "
227172|NCT00583973|"~     Parenteral iron therapy is now commonly administered to dialysis patients with the majority~     of patients receiving this therapy as part of the treatment for their anemia. Although~     intravenous iron has improved clinical response to recombinant erythropoietin, there is a~     concern that iron therapy may have deleterious effects in Chronic Kidney Disease (CKD)~     patients. Iron can damage tissues by catalyzing the conversion of hydrogen peroxide to~     free-radical ions that attack cellular proteins, DNA and membranes as part of oxidative~     stress. Numerous in vitro studies have shown tissue toxicity from iron and increased~     infectious potential. Oxidative stress can also lead to activation of the systemic~     inflammatory response with the release of a number of key cytokines and growth factors. There~     is now a link between inflammation, oxidative stress and acceleration of vascular disease in~     both patients with normal as well as reduced renal function. In a study comparing normal~     versus low hematocrit levels in hemodialysis patients, mortality was higher in the normal~     hematocrit group. The major difference between the two groups has been attributed to the fact~     that patients in the normal hematocrit group received significantly more iron than the~     patients with low hematocrit. There was a 2.4 fold greater mortality rate in patients~     receiving parenteral iron.~      The effect of parenteral iron administration on activation of the systemic inflammatory~     response in hemodialysis patients has not been evaluated. The purpose of this study is to~     measure a number of key cytokines, inflammatory and oxidative stress markers in hemodialysis~     patients receiving iron repletion therapy as part of their standard care.~   "
227173|NCT00583960|"~     Retrospective chart review of UCDMC patients who have undergone esophageal or tracheal~     balloon dilation to record data including age, gender, diagnosis pre-and post-procedure~     eating assessment tool, esophagoscopy findings, tracheobronchoscopy findings, and pre-and~     post-procedure videofluoroscopic findings.~   "
227174|NCT00583947|"~     To determine the safety and tolerability of Arformoterol Tartrate in children with asthma~   "
227175|NCT00583934|"~     The purpose of this study is to evaluate the prevalence of esophageal pathology in~     asymptomatic patients with a history of head and neck cancer.~   "
227176|NCT00583921|"~     Single center investigator initiated sponsored by Guidant Boston Scientific Corp. to evaluate~     the benefit of ventricular rate regularization (VRR) in patients with congestive heart~     failure (CHF) and significant atrial fibrillation (AF) burden.~   "
227177|NCT00583908|"~     The purpose of this study is to determine the relative performance of a new toric soft~     contact lens against three toric contact lens currently available in market, specifically~     with orientation and visual acuity when head is tilted at 90 degrees.~   "
227178|NCT00583895|"~     Atopic dermatitis is one of the most common skin diseases, with a lifetime prevalence of up~     to 20%, and an increasing number of cases. Although there are a variety of treatments the~     number of specific medications for treating this chronic disease is limited and often not~     helpful, especially in more severe cases. In addition,most treatments may be used only for a~     limited period or are less effective in the long term (tachyphylaxis). The development of new~     compounds is mandatory for treatment of this often chronically recurring disease. The current~     trial will determine the efficacy, safety and tolerability of the endogenous compound~     imidazole-4-carboxylic acid (ImCOOH) administered as a topical cream twice daily for 14 days~     in patients with atopic dermatitis.~   "
227179|NCT00583882|"~     This project proposes to answer the following questions:~      To determine the incidence of infection with three primary schedules of central venous~     catheter exchange in pediatric burn patients and to determine the regimen that will minimize~     infectious risk in children with burns.~      The scientific knowledge to be acquired through this project is of likely benefit to the care~     of children with orthopaedic problems, spinal cord injuries or burns as follows:~      The intention is to improve the outcomes in burned children by minimizing one of the most~     frequent causes of infection in the burn intensive care unit, those from central venous~     catheters. Decreasing infections will decrease morbidity, decrease length of stay, decrease~     costs, and decrease mortality in burned children~   "
227180|NCT00583869|"~     This is a randomized, prospective, double-blind pilot study designed to evaluate the~     potential effectiveness of pregabalin in post-operative pain management for patients who have~     sustained a fracture.~   "
227181|NCT00583856|"~     Investigator initial study to evaluate the use of preoperative computer modeling and the~     intraoperative navigation to guide reconstruction of the maxillofacial skeleton.~   "
227182|NCT00583843|"~     Accurate targeting of treatment sites should increase local control by radiation therapy for~     breast-cancer lumpectomy patients. Currently, ultrasound localization is used for prostate~     cancer patients to locate the prostate before daily radiation treatments. There is now~     documented evidence that the lumpectomy site does change during the external radiation~     therapy. Thus, treatment efficacy should be increased by localizing the target, monitoring~     volume changes, and adjusting the radiation target prior to the boost radiation dose.~   "
227183|NCT00583830|"~     The purpose of this study is to evaluate the efficacy (disease response) and safety of~     mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects~     with advanced non-small cell lung cancer (NSCLC).~   "
227184|NCT00583817|"~     The purpose of this study is to assess the role of ascending and/or aortic arch~     aneurysm/dissections treatment using a novel endovascular prosthesis in high risk surgical~     patients.~   "
227185|NCT00583804|"~     The purpose of this study is to evaluate the effectiveness of an implanted stimulator and~     sensor for providing hand and arm function for individuals with cervical level spinal cord~     injury.~   "
227186|NCT00583791|"~     The objective of this feasibility study is to investigate the safety of the AMPLATZER~     Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are~     hemodynamically significant and are either isolated or in conjunction with other congenital~     heart defects in infants and children.~   "
227187|NCT00583778|"~     This is a double blind, controlled clinical trail testing whether three doses of 1.25 mg of~     nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will~     lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of~     levalbuterol alone every 20 minutes.~      The primary hypothesis of this study is that three doses of 1.25 mg of nebulized levalbuterol~     in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater~     bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone~     every 20 minutes. The secondary hypothesis is that the treatment combination of levalbuterol~     and ipratropium will lead to fewer hospitalizations than levalbuterol alone in patients with~     acute asthma exacerbation. Other secondary objectives include (1) evaluating the relationship~     between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and FEV1,~     (2) the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on~     presentation and change in FEV1,(3) time to event analysis for an improvement of 15%, 20%,~     30%, 40%, and 50% in FEV1 from initial presentation value, (4) analysis of FEV1 at discharge.~   "
227188|NCT00583765|"~     Dialysis requires thinning of the blood to prevent clotting in the dialysis machine. Thinning~     of the blood is necessary but some forms of blood thinners may cause bleeding. Therefore,~     researchers are seeking ways to minimize bleeding risks and ensure effective dialysis.~      One medication used to thin the blood in the dialysis machine is citrate. Citrate has the~     advantage of having its blood-thinning properties quickly reversed by calcium in the~     patient's blood. As a consequence, only the blood in the machine is thinned, greatly reducing~     the risk of bleeding when dialysis is carried out using other blood thinners. Until now, most~     patients who received citrate for dialysis were administered the citrate in a separate~     infusion through an IV pump into the dialysis machine. This method requires complex~     monitoring and calculations. This study is about Prismocitrate which is a dialysis fluid very~     similar to the regular dialysis fluid that is used in this intensive care unit, except that~     this fluid already contains exactly the correct amount of citrate. Thus, this method does not~     require a separate pump for citrate and calculations to pump the citrate into the blood as it~     goes through the kidney machine. Having the citrate already contained in the dialysis fluid~     simplifies the procedure and reduces the possibility of calculation errors.~      This study seeks to determine if this simplified means of providing blood thinning in the~     kidney machine also results in the correct balance of blood salts.~   "
227189|NCT00583752|"~     The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will~     induce an anti-PSA immunity that will result in the destruction of the remaining prostate~     cancer cells.~   "
227190|NCT00583739|"~     A randomized trial from the British National Health Service found that supervised exercise~     benefits women with early stage breast cancer with improved functional and psychological~     benefit after a 12-week intervention and 6 months later. Considering the needs of breast~     cancer patients and survivors and the reported benefits of exercise and yoga intervention,~     the investigators propose a pilot study of an 8-week yoga intervention in breast cancer~     patients. This study would specifically address measures of fatigue and psychosocial distress~     in the population of breast cancer patients during treatment and within the year following~     treatment. Currently there is very limited literature on yoga intervention in this~     population.~   "
227191|NCT00583726|"~     This study aims to determine if a motivational interviewing counseling style can help women~     eat a healthy diet and exercise during breast cancer treatment and beyond.~   "
227192|NCT00583713|"~     To evaluate and compare the effects on safety measures and clinical chemistry after BLI800 in~     two groups of patients and one group of healthy controls. The patient groups will be those~     with mild or moderate hepatic impairment or moderate renal disease.~   "
227193|NCT00583700|"~     This study seeks to determine if a combination of Trental and Vitamin E prevents the~     development of radiation fibrosis in women treated with radiation for the definitive~     management of their breast cancer.~   "
227194|NCT00583687|"~     The purpose of this study is to compare changes of minimally invasive arterial pulse contour~     cardiac output with changes of intermittent and continuous thermodilution cardiac output by~     pulmonary artery catheter in hemodynamic unstable patients with rapid changing vascular tone~     (changing dosage of vasoactive drugs or inotropics, or volume challenge). Simultaneously,~     global parameters of oxygen delivery and consumption will be compared with regional flow~     parameters and tissue oxymetry (near infrared spectrometry and laser-Doppler). While~     continuous thermodilution cardiac output is used for patient management, pulse contour~     cardiac output, intermittent thermodilution cardiac output and tissue oxymetry is only used~     for monitoring.~   "
227195|NCT00583674|"~     This is a phase 2, randomized, double blind, placebo controlled, multi-center study to~     estimate the improvement in progression free survival (compared to control subjects) and~     evaluate the safety and tolerability of AMG 386 in combination with Cisplatin & Capecitabine~     in the treatment of subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal~     Esophageal Adenocarcinoma. AMG 386 is a man-made medication that is designed to stop the~     development of blood vessels in cancer tissues. Cancer tissues rely on the development of new~     blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to~     grow.~   "
227216|NCT00583401|"~     Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least~     two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale~     and who have failed conventional therapy.~   "
227196|NCT00583661|"~     The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric~     Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance~     of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and~     Drug Administration under a Humanitarian Device Exception (HDE).~   "
227197|NCT00583648|"~     The implementation of nursing urinanlysis protocols based off of symptoms of urinary~     infections will significantly decrease the length of a patient's stay in the Emergency~     Department.~   "
227198|NCT00583635|"~     Use of Juice Plus+ food supplements, when initiated in the first trimester and used~     continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy~     complications. This is a prospective randomized and blinded placebo controlled study~     sponsored by NSA, LLC of Memphis, TN.~   "
227199|NCT00583622|"~     The goal of this clinical research study is to learn if bevacizumab, when given in~     combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan,~     cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin),~     can help to control ovarian cancer during a stem cell transplant. The safety of this drug~     combination will also be studied.~   "
227200|NCT00583609|"~     To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently~     treated with PEG3350 powder for treatment of constipation.~   "
227201|NCT00583596|"~     AGA-004 - The objective of the study is to determine safety, effectiveness and clinical~     utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 -~     The objective of this study is to evaluate the long term safety and effectiveness issues that~     may not have have been adequately addressed during AGA-004.~   "
227202|NCT00583583|"~     Emergency/compassionate use for the AMPLATZER Duct Occluder~   "
227203|NCT00583570|"~     Specific Aim: To determine the effect of a phosphorus additives educational intervention on~     serum phosphorus levels.~      Hypothesis: Educating dialysis patients regarding phosphate containing additives will result~     in improved serum phosphorus levels.~   "
227204|NCT00583557|"~     This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects~     with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.~   "
227205|NCT00583544|"~     Targacept, Inc. is studying TC-2216 for a potential role in the treatment of central nervous~     system (CNS) neurobiological disorders in anticipation of seeking an indication in depression~     and/or anxiety.~   "
227206|NCT00583531|"~     This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks.~     Patients will discontinue antibiotics at study entry. They may continue other previously~     prescribed treatments (e.g., probiotics and/or nutritional agents) at the discretion of the~     study doctor. The purpose of the study is to assess whether the investigational medication~     AST-120 will be a safe and effective treatment for the symptoms of pouchitis, a chronic~     inflammatory condition, in patients whose symptoms have not responded well to antibiotics. An~     initial group of 10 patients will be enrolled. If there are no serious side effects~     associated with the study drug and at least 3 of the 10 patients respond, a second group of~     10 patients may be enrolled. Patients will have clinic visits at the start of the study and~     at week 4. Patients will be checked by phone on a weekly basis for symptom response,~     compliance and development of side effects. Endoscopies will be performed at the start of the~     study and at week 4 or early termination.~   "
227207|NCT00583518|"~     The primary objective of the study is to explore the relationship between a new image~     technology (ImaTx), that analyzes the trabecular structure of the bone using digitized~     radiographs and the bone mineral density (BMD) measured by Dual X-ray Absorptiometry (DXA) in~     the lumbar spine of postmenopausal (PM) women with osteoporosis (OP) after treatment with PTH~     (1-84).~   "
227208|NCT00583505|"~     Emergency/Compassionate use of the AMPLATZER Membranous VSD Occluder~   "
227209|NCT00583492|"~     This is a randomized, controlled trial that will test the hypothesis that~     replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy~     intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80~     Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk~     profile.~   "
227210|NCT00583479|"~     The purpose of this prospective randomized study is to compare the clinical effectiveness of~     EUS-guided CB performed with a single injection versus two injections of medication into the~     celiac ganglion region.~   "
227211|NCT00583466|"~     For removal of large flat lesions of the gastro-intestinal tract injection of a solution~     under the lesion creates a safety cushion and protects from damage to the gastrointestinal~     tract wall. Various solutions are currently used, but some of them are easy to inject but~     quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl~     methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive~     and not always available. The investigators performed previously animal experiments which~     demonstrated that blood is easy to inject and creates a protective cushion which lasts longer~     than other fluids which are currently used for protective cushion creation.~   "
227212|NCT00583453|"~     The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces~     post-operative narcotic use.~      To test this hypothesis, the study is placebo controlled (sugar pill). Half of the~     participants will receive a sugar pill, half will not.~      All participants will receive the standard post-operative pain medications.~      We ask participants to log the amount of medications they use daily, and the amount of pain~     they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain~     medication needed.~   "
227213|NCT00583440|"~     This is a randomized trial testing the efficacy of a modified 12-step facilitation therapy~     for individuals with serious mental illness and alcohol use disorders, compared to usual~     treatment. 135 participants are randomized in 2:1 ratio to the modified 12-step facilitation~     (12 sessions of individual counseling) vs. treatment as usual. The primary hypothesis is that~     those receiving 12-step facilitation will have better drinking outcomes (percent days~     abstinence and drinks per drinking day)at end of treatment.~   "
227214|NCT00583427|"~     The purpose of this study is to see if a medicine called Sulodexide will help prevent or slow~     down the progression of Membranoproliferative Glomerulonephritis type II/Dense Deposit~     Disease. Sulodexide is not yet FDA approved and has not been studied in children.~      Study aim/hypotheses: to measure the efficacy of Sulodexide treatment in patients with the~     above disease/s.~   "
227217|NCT00583388|"~     Acute cardiac and vascular events, like heart attack and sudden cardiac death manifest a~     clear surge in the early morning hours around the time of waking, so that their peak onset is~     between 6AM and 11AM. The mechanisms are not fully understood, but we had shown that healthy~     subjects have impaired vascular reactivity in the early morning (endothelial dysfunction).~     This is associated with a decrease in nitric oxide levels (a substance that promotes~     vasodilatation). We also have described that vessel reactivity and the levels of this~     substance can recover by noon only when people breakfast.~      L-arginine is a semi-essential amino acid found in large quantities in chicken, in fish, and~     beans and is the substrate for the production of nitric oxide Therefore we want to test if~     there is a beneficial effect of administration of L-arginine on the circadian pattern of~     vessel reactivity. Our goal is to understand why cardiovascular events are more likely to~     happen in the early morning and how to prevent.~      The research will help us to understand the efficacy, acute effects and tolerability of high~     doses of L-arginine. This can lead to future research to assess long term effects of~     L-arginine supplements to prevent cardiovascular events in the early morning hours.~   "
227218|NCT00583375|"~     STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the gold~     standard (ABG) in a representative clinical model (hindfoot and ankle fusions)~      STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous~     bone graft in applications as shown by non-inferiority analysis~      STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to~     facilitate fusion in conditions or injuries requiring bone graft in a representative clinical~     fusion model and thus the opportunity to provide equivalent union rates as ABG without~     necessitating an additional invasive procedure to harvest the graft~      REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA)~     Application as a bone regeneration system, pivotal phase~   "
227219|NCT00583362|"~     This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™~     in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.~   "
227220|NCT00583349|"~     The intravesical treatment of bladder cancer with Abraxane is more desirable than other~     taxanes due to its ability to be diluted in water and not lipid-based solutions allowing it~     greater access to sites in the bladder. Thus, we are interested in investigating Abraxane's~     safety, toxicity, and efficacy profile for the treatment of recurrent transitional cell~     cancer of the urinary bladder in a combined phase I & II trial. The phase I trial is designed~     as a dose-escalation study with cohorts of threes that will enroll a maximum of 18 patients.~     Dose increases will occur in groups of three patients, with each successive group receiving~     an increased concentration of Abraxane intravesically. No dose increase will occur until each~     member of the previous cohort has undergone the first instillation of the medication without~     experiencing a dose-limiting toxicity (DLT). Any patient who experiences a DLT will be~     removed from the trial and treated appropriately.~      If one patient in the cohort experiences a DLT an additional three patients will be enrolled~     and treated at that dose-level. If none of the additional three patients experience a DLT,~     the next group of patients will be started on the next higher dose level.~      If at any dose level, two or more patients experience a DLT the previous dose level will be~     considered as the maximum tolerated dose (MTD). An additional three patients (for a total of~     six patients) will then be treated at the MTD. If less than two patients experience a DLT~     this dose level will be established as the MTD. The phase II aspect is designed in a Simon II~     stage format in which to satisfy our study powering, the first stage there will be 10~     patients enrolled. If there are 2 or more successful treatments in that group (negative urine~     cytology and bladder biopsy after 6 months), then the first stage will pass the rejection~     rule, and up to another 19 patients will be enrolled. If at any point in the study, there~     have been a total of 6 or more successes, then the phase II aspect will be considered a~     successful trial and the study will be completed at that point.~   "
227221|NCT00583336|"~     ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be~     used to detect no-flow in symptomatic patients with shunt obstruction.~      Secondarily, the ShuntCheck test will yield the clearest results when patients are tested~     sitting up (or alternatively while supine)~   "
227222|NCT00583323|"~     2-[18F]-fluoro-2-deoxyD-glucose positron emission tomography (FDG PET) has proven to be a~     valuable clinical tool for the staging and surveillance of lymphoma.1-6 Occasionally, lymph~     nodes in the mesentery and retroperitoneum can be difficult to distinguish from normal bowel~     activity on PET scans despite three-plane and cine maximal image projection (MIP) imaging.~     This uncertainty limits the clinical usefulness of PET in some cases of lymphoma.7-8 In~     addition, bowel activity can also hinder interpretation of PET scans in other types of solid~     tumors including melanoma and colorectal cancer.6,9,10 Our goal is to determine how well~     diphenoxylate/atropine 5mg/0.05mg (Lomotil) decreases bowel activity and how this decrease~     impacts clinical decision-making, specifically for lymphoma staging and surveillance. This is~     a prospective, randomized, double-blinded study involving 60 patients undergoing PET scans~     for newly diagnosed or recurrent, untreated lymphoma.~   "
227223|NCT00583310|"~     Individuals with prehypertension are at risk for developing cardiovascular disease and~     sustained hypertension. Modifying lifestyle behaviors (diet, weight loss, sodium intake,~     physical activity, alcohol intake) has been shown to reduce blood pressure in hypertensives.~     Participants in this study will be enrolled in one of two groups. Participants in the first~     group will receive usual care, and participants in the second group will receive a 4 session~     telephone-based lifestyle intervention. The goal of the study is to determine whether this~     intervention is effective in promoting behavior change and reducing blood pressure among~     prehypertensives.~   "
227224|NCT00583297|"~     The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine~     if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in~     predicting life-threatening heart rhythms in patients with ischemic heart disease, left~     ventricular dysfunction, and non-sustained tachycardia. The purpose of the ABCD Genetic~     sub-study is to identify genetic markers that predict TWA status and arrhythmia risk in this~     same population.~   "
227225|NCT00583284|"~     Patients with ventricular tachycardia (VT) undergo catheter ablation. During the ablation~     procedure, the heart is mapped to determine areas of heart muscle damage. The heart scarring~     areas are often the source of the VT. Delayed enhancement CT has recently been used to~     determine areas of scarring . This study is to determine if the areas of damaged heart muscle~     mapped with the delayed enhancement CT correlate with the same areas that are determined~     during the catheter ablation.~   "
227226|NCT00583271|"~     The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided~     CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are~     already undergoing celiac block for clinical reasons.~   "
227227|NCT00583258|"~     Patients who present for the first time to Emergency Room with renal colic due to a distal~     ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive~     Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study~     is to assess if patients treated with Xatral will have a higher spontaneous passage rate of~     their ureteral stone than those treated with placebo.~   "
227228|NCT00583245|"~     Knee osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is~     one of the most disabling problems facing the growing population of older adults. The~     long-term objective of this research is to reduce disablement of older adults with~     symptomatic knee OA. The principle of specificity of training indicates that exercises that~     closely approximate the goal functional activity are most effective in improving physical~     performance during that activity. Based on this principle, the specific aim of this pilot~     study is to design a patient-specific gait training intervention using analysis of~     compensatory joint moments and energy expenditure. Successful completion will inform~     rehabilitation for maintaining or improving mobility as well as explore the mechanism of~     effect.~   "
227229|NCT00583232|"~     The metabolic response to Crohn's disease, including increased proteolysis and lipolysis and~     changes in energy expenditure, plays a significant role in the resulting malnutrition from~     which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory~     cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has~     been incriminated in the mechanism of weight loss in many different chronic diseases, and~     causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven~     to be an effective therapy for ulcerative colitis.~      The purpose of this study is to compare changes in protein and lipid metabolism, as well as~     resting energy expenditure, before and after therapy with anti-TNF-alpha antibody~     (infliximab) or corticosteroids in children with recurrent Crohn's disease. Performing this~     study will better define the changes in nutrition status observed in these children following~     remission of active Crohn's disease, and potentially lead to changes in medical and~     nutritional management of these children.~   "
227230|NCT00583219|"~     The primary objective of this pilot study is to evaluate the safety and efficacy of direct~     instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of~     treating women with symptoms of overactive bladder and secondary urinary incontinence. In~     doing so, we will focus on estimating the percentage of women who experience an improvement~     in their urinary incontinence symptoms at one month and three months following this novel~     instillation technique.~   "
227231|NCT00583206|"~     Severe sepsis will provoke signals leading to muscle atrophy and weakness. Electrical~     stimulation will reduce the impact of sepsis.~   "
227232|NCT00583193|"~     The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective~     treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).~   "
227233|NCT00583180|"~     The use of capsaicin as a potential analgesic drug for postoperative pain relies on the~     ability of capsaicin to induce membrane lysis of c-nerve fibers. In a previous randomized~     placebo controled blinded study of this effect we found a significant effect of capsaicin~     versus placebo. Before surgery all patients were examined by quantitative sensory testing to~     evaluate sensory function. In this study an identical sensory testing will examine if changes~     to the sensory function in capsaicin treated patients is identical to placebo treated~     patients.No new intervention will be performed~   "
227234|NCT00583167|"~     Understanding whether or not viral replication occurs in the brain during chronic untreated~     HIV-1 infection is of undeniable importance, and has implications for treatment and research~     priorities. Evidence suggests that viral replication in the CNS occurs at the extremes of~     HIV-1 disease. Brain involvement has been reported during acute infection, and there is~     convincing evidence of CNS viral replication during HIV-associated dementia (HAD) and~     advanced AIDS. Some human and primate data suggest that viral RNA and proteins may be absent~     from brains of some individuals with chronic untreated HIV-1 infection despite abundant~     proviral DNA. However, the extent of viral replication in the brain is not known for most of~     the 42 million people worldwide living with untreated HIV-1 infection.~      Why is viral replication in the brain such a pivotal issue? Microglial cells and macrophages~     are primary targets for intrathecal HIV-1 replication, and this can promote neuronal injury~     through direct effects of gp120 and tat, and indirect induction of toxic mediators. Low-grade~     injury over years or decades would likely be deleterious, particularly as the population~     ages. Because treatment guidelines allow systemic HIV-1 replication to continue until CD4+ T~     cell counts decline considerably, antiretroviral therapy (ART) is not recommended for many~     persons living with HIV. Demonstrating replication in the brain during chronic HIV-1~     infection may affect treatment strategies and encourage investigation.~      Identifying factors that modulate intrathecal viral replication is equally important.~     Anti-HIV-1 cytotoxic T lymphocytes (CTL) partially control systemic viral replication and~     delay disease progression. Although available data has been provocative, the role of anti-HIV~     CTL in the CNS has received little attention. To fill this gap we will examine relationships~     between intrathecal viral replication, CTL responses, and glial activation/proliferation~     during HIV-1 infection. These studies will be relevant not only to AIDS but to other~     inflammatory diseases of the CNS as well.~   "
227235|NCT00583154|"~     To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated~     adults.~   "
227236|NCT00583128|"~     The objective of this study is to evaluate the safety and effectiveness of the experimental~     drug AST-120 in treating patients with non-constipating IBS. The study will test whether or~     not patients receiving AST-120 experience at least a 50% reduction in the number of days with~     abdominal pain compared to placebo.~   "
227237|NCT00583115|"~     The purpose of this study is to find out if the drug, Gleevec, is safe and effective in~     treating children with Pulmonary Hypertension.~   "
227238|NCT00583102|"~     The purpose of this study is to test the safety and effectiveness of combining a drug known~     as Lovastatin to the chemotherapy drug cytarabine. Lovastatin is currently used to lower~     blood cholesterol levels and lab data suggests that it increases the anti-leukemia activity~     of cytarabine. This research is being done because high doses of cytarabine induce remissions~     in only about 25% of patients with acute myeloid leukemia.~   "
227239|NCT00583089|"~     To gather data and analyze decompensation events.~   "
227240|NCT00583076|"~     The aim of the study is to assess the safety and efficacy of an investigational agent,~     AST-120, in treating patients with active pouchitis. This is an open-label trial which means~     that all patients will receive AST-120 in 2g sachets (packets)three times a day for 4 weeks.~     All antibiotics, probiotics and nutritional agents must have been discontinued for at least 2~     weeks prior to study entry. An initial group of 10 patients will be enrolled. If there are no~     serious adverse events associated with the study drug and at least 3 of the 10 patients~     respond, a second group of 10 patients will be enrolled. In the second group of patients,~     those patients who are considered responders or who are in remission are eligible to receive~     open-label AST-120 for as long as response is maintained up to a maximum of 52 weeks.~     Patients will have clinic visits at the start of the study and at week 4. If continuing on~     open label AST-120 after week 4, patients will have clinic visits every 12 weeks to assess~     the continuing safety and efficacy of AST-120. Endoscopies will be performed at the start of~     the study, week 4, week 28, week 52 or early termination.~   "
227243|NCT00583037|"~     Neurally Adjusted Ventilatory Assist (NAVA) is a new mode of mechanical ventilation that is~     controlled by the electrical activity of the diaphragm (EAdi). The EAdi is a signal that~     represents the patient's breathing effort, and hence with NAVA, the assist being delivered is~     synchronized and proportional to the demands of the patient. This is a prospective~     physiological study of the feasibility of NAVA ventilation over 24 hours. The aim is to~     demonstrate that NAVA can maintain spontaneous breathing and unload the respiratory muscles~     during both sleep and wake cycles over a 24 hour period.~   "
227244|NCT00583024|"~     This investigational study involves treatment with an Ad/PSA vaccine for men with prostate~     cancer who present with evidence of hormone refractory metastatic disease.~   "
227245|NCT00583011|"~     This study is been designed to answer the question of whether local anesthesia (1% lidocaine)~     decreases the perception of pain associated with amniocentesis in a randomized double blind~     placebo controlled manner. Our objective is to determine the effect of local anesthesia on~     the maternal pain perception from an amniocentesis.~   "
227246|NCT00582998|"~     This project is designed as a prospective, randomized, comparative study evaluating the use~     of a negative pressure vacuum device in treating soft tissue injuries and the surgical~     incision following open reduction and internal fixation of calcaneus, tibial plateau, and~     pilon fractures.~   "
227247|NCT00582985|"~     This study is being performed to evaluate the safety and tolerability of the TRC105~     monoclonal antibody.~   "
227248|NCT00582972|"~     The purpose of this study is to measure the effect of omeprazole on intestinal calcium~     absorption in postmenopausal women.~   "
227249|NCT00582959|"~     The purpose of this study is to test a new technology for obtaining x-ray images of your~     treatment fields when you are positioned on the treatment machine, to determine whether this~     new system is as reliable and easy to use as conventional systems.. These so-called portal~     images are normally taken on a weekly basis, prior to your radiation treatment. The new~     portal imaging system to be tested is designed to produce better quality images than are~     currently achievable, but with no additional dose or added treatment time.~   "
227250|NCT00582946|"~     Our goal is to design and build a new hearing aid system, which mitigates the most common~     complaints that hearing aid users have. These include hearing in multi-talker situations,~     poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of~     their own voice. Current efforts, with limited success, use signal processing methods rather~     than restoring more closely the normal auditory function. We plan to achieve our goal by~     reducing to practice three key enabling concepts. The first is to replace the current~     acoustic transducer with a non-acoustic mechanical output transducer that directly actuates~     the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic~     membrane in a manner similar to the way a contract lens floats on the eye. The second is to~     increase the output bandwidth of the hearing aid. The third key concept is to place a~     wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to~     the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers~     amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal~     configuration will perform better than conventional hearing aids when there are competing~     talkers in the background. First phase includes verification the capability of the system to~     deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing~     loss in the target fitting range.~   "
227251|NCT00582933|"~     The purpose of this research study is:(1) to determine if high doses of chemotherapy without~     total body irradiation can allow selected stem cells to take and grow,(2) to determine if~     selected stem cells from the blood or marrow can take and not cause a complication called~     graft-versus-host disease (GvHD) and (3) to evaluate the side effects of the combination of~     chemotherapy drugs used for these transplants. In the last 10 years we have developed~     chemotherapy combinations to be used for this T-cell depleted transplant protocol. By using~     three chemotherapy drugs (IV busulfan, melphalan and fludarabine), we hope to have a good~     chemotherapy combination to kill cancer cells, and to make the graft take, without the side~     effects of total body irradiation. The chemotherapy drugs to be tested in this protocol are~     busulfan, melphalan and fludarabine, all of which have been used successfully for stem cell~     transplantation, but not given together as in this specific regimen. This is what is being~     tested in this study.~      Our initial trials in the 1980's with T-cell depleted transplants showed less GvHD, but the~     overall results of the transplants were not better. The reason for this was that the stem~     cells did not take and engraft in 15% of our adult patients. This failure of the stem cells~     to take can leave patients without bone marrow or blood cells necessary for life. Most stem~     cell transplants were done using bone marrow (BMA) obtained from the donors. However, if we~     give a medication called G-CSF by shots to the donor, we can collect peripheral blood stem~     cells (PBSC) and use them for transplant. The advantage of this approach is that we can~     collect 2-20 times more stem cells than that obtained from the marrow. It has been proven~     that a larger number of stem cells in the graft make it more difficult for the patient to~     reject the stem cells. Some donors may be too small to provide peripheral blood stem cells or~     they may not want to take G-CSF shots. In these cases the donors will have their marrow~     collected in the operating room under general anesthesia.~      Stem cell transplants can lead to a condition known as acute graft-versus-host disease or~     GvHD. This disease is caused by an assault by certain cells in the marrow or blood (T-cells)~     of the donor (graft) against your body (the host). These T-cells see your body as foreign and~     attack it. The disease causes a skin rash, liver disease, and diarrhea. Methods were~     developed at this institution to prevent GvHD. These methods take out most of the T-cells~     (responsible for GvHD) from the marrow or blood stem cells before transplant. This is called~     T-cell depletion or stem cell selection. In this hospital, we use two types of methods of~     T-cell depletion: one method is used with peripheral blood stem cells and one for bone~     marrow. Both these techniques have been successful in preventing both acute and chronic GvHD.~     You will receive a T-cell depleted stem cell transplant.~   "
227252|NCT00582920|"~     The purpose of this study is to examine for changes in the bone scan after treating with~     zoledronic acid (Zometa™). This study is designed to show if intravenous (IV)~     bisphosphonates, which are infused by vein, such as pamidronate (Aredia™) or zoledronic acid~     (Zometa™), cause changes in the result of bone scans in women with metastatic breast cancer.~     Both bone scans and the IV bisphosphonates are components of routine care of women with~     breast cancer that has spread to the bone.~   "
227263|NCT00582777|"~     4. Methods 4a. Overview The study will be conducted in participants in the African-American~     Study of Kidney Disease (AASK) Cohort study as a randomized three period cross-over trial.~      Eighty five percent of AASK cohort participants are currently on an ACE inhibitor or~     angiotensin receptor blocker; the most commonly used ACE inhibitor is ramipril. The new~     strategies proposed in this pilot study will remain ramipril-based, to maintain the overall~     blood pressure control achieved thus far.~      The antihypertensive regimens proposed are as follows:~        -  AM dosing of ramipril and other once daily medications in the participants~          antihypertensive regimen (termed USUAL),~        -  Bedtime dosing of ramipril and other once a day medications in the participant's~          antihypertensive regimen (termed HS-DOSING), and~        -  their current antihypertensive regimen plus an additional antihypertensive agent dosed~          at bed time; the choice of the additional agent will be tailored based on prespecified~          clinical guidelines (termed ADD-ON DOSING)~      The usual arm serves as the comparator arm. The hs dosing and add-on dosing arms test~     practical strategies that could be tested in a subsequent clinical outcomes trial and that~     could be implemented in clinical practice. We hypothesize that both arms will reduce~     nocturnal BP in comparison to usual dosing. We further hypothesize that the hs dosing arm~     will raise daytime BP somewhat but have no net effect on 24 hour BP and that the add on~     dosing arm will have no effect on daytime BP but lower 24 hour BP.~      This pilot study will begin after the last scheduled AASK Cohort study visit. Eligible~     participants will be treated for 6 weeks on each of 3 antihypertensive regimens. The sequence~     of the regimens will be random. Each period of the three periods will have 2 visits, one~     visit at 3 weeks and one visit at 6 weeks. In the last week of each 6-week period, a 24-hour~     ABPM will be obtained. The primary outcome variable is nocturnal BP; each pair wise~     difference between the regimens will be calculated.~   "
227253|NCT00582907|"~     Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of~     fever, abdominal pain, chest pain, arthritis and rash. There are 5-15% of patients who~     continue to have FMF attacks despite treatment with colchicine or who cannot tolerate~     colchicine. Currently there are no alternatives to colchicine. Pyrin, the protein that has a~     defect in FMF has an important role in the regulation of a molecule called interleukin (IL)-1~     beta production and activity. This molecule is very important in the process of inflammation~     in FMF.~      Therefore we propose to use IL-1 Trap (Rilonacept), a medication that binds and neutralizes~     IL-1.~      We will enroll in this study 17 subjects from the age of 4 years, including adults with~     active FMF despite colchicine therapy. Subjects will receive in random order two 3-month~     courses of Rilonacept at 2.2 mg/kg (maximum 160 mg) by weekly subcutaneous injection and two~     3-month courses of placebo injection. If patients have at least two FMF attacks during a~     treatment course they will be able to get if they choose the other treatment until the end of~     that treatment course. Our hypothesis is that Rilonacept will decrease the number of acute~     FMF attacks and will be safe to use. This study may confirm the importance of IL-1 in the~     cause of FMF.~      Funding source - FDA Office of Orphan Products Development~   "
227254|NCT00582894|"~     To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients~     who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for~     malignant hematological diseases~   "
227255|NCT00582881|"~     Systemic lupus erythematosus (SLE) and mixed connective tissue disease (MCTD) are long-term~     autoimmune diseases in which the immune system attacks parts of the body. The abnormal immune~     reaction causes inflammation of and damage to various body parts and can affect joints, skin,~     kidneys, heart, lungs, blood vessels, and the brain. SLE and MCTD often affect young women,~     especially black and Hispanic women, and there is no known cure. Knowing more about SLE and~     MCTD will help in developing new and effective treatments. The purpose of this study is to~     characterize immune system abnormalities, genetic components, and disease progression in~     people with SLE and MCTD.~   "
227256|NCT00582868|"~     The purpose of this study is to investigate if brain oxygen levels, levels of a specific~     protein in the cerebrospinal fluid and blood (Cleaved-tau protein), and brain blood flow can~     predict spasm of brain blood vessels after bleeding in the brain from a ruptured aneurysm.~   "
227257|NCT00582855|"~     This study will investigate AQW051 in patients with either mild Alzheimer's disease or~     amnestic mild cognitive impairment. The effect on cognitive impairment will be measure using~     validated computerized tests which measure cognitive function. This study will also explore~     the safety and tolerability of AQW051 in these patients.~   "
227258|NCT00582842|"~     The purpose of this study is to assess quality-of-life of men with prostate cancer.~     Quality-of-life means how you feel about your life as a result of your disease and its~     treatment. The investigators hope that this questionnaire will help show how prostate cancer~     treatments affect quality-of-life. It will help doctors and future patients to make better~     treatment choices. Some men may wish to have a more demanding treatment with a higher risk of~     harmful effects. Others may prefer a treatment that will have the smallest effect on their~     quality-of-life.~      This questionnaire will help us measure these effects and decide which is the best treatment~     for a given patient.~   "
227259|NCT00582829|"~     This proposed study will use previous study results to guide the development and evaluation~     of interventions to improve CRC screening acceptance. The proposed study will evaluate the~     impact of three interventions to promote CRC screening among siblings in this increased-risk~     group, who are not currently compliant with CRC screening guidelines: 1) a generic print~     intervention; 2) a tailored print intervention, and; 3) a tailored print plus tailored~     telephone counseling intervention.~   "
227260|NCT00582816|"~     This study will assess the feasibility of utilizing a reduced intensity conditioning regimen,~     in the setting of haploidentical transplantation, for patients with recurrent acute~     lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the~     feasibility and safety of administering post-transplant NK cell infusions will be evaluated.~     Data obtained from this study will help determine the efficacy of allogeneic HSCT in the~     treatment of pediatric sarcomas and add to the small body of literature utilizing~     haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also~     further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic~     HSCT. The main benefit to society is that this study will explore a novel therapy for~     children with highly refractory cancer who are felt to be incurable with conventional~     approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity,~     then this will open up a new area of clinical research to better define the efficacy of this~     approach for specific childhood malignancies.~   "
227261|NCT00582803|"~     Women with strong family histories of breast cancer are at increased risk to have breast~     cancer. Women whose close relatives have had breast cancer often have more breast cancer~     screening than other women their age. To increase the chance that any breast cancer will be~     caught early, women at risk often take part in special screening programs. These programs~     involve more frequent visits to the doctor for breast exams, yearly mammography, and new~     types of exam like breast Magnetic Resonance Imaging (MRI). Studies are going on to find out~     whether these programs are better than standard screening. The purpose of this study is to~     find out how these programs impact women's quality of life. The study will also try to learn~     what factors make it hard to take part in the programs. We hope to be able to design new~     programs that are easier to follow.~   "
227262|NCT00582790|"~     This study is being done to see if we can improve the response of Interleukin-2 by adding~     Zoledronic acid. The effectiveness of the combination of drugs in kidney cancer is unknown~     and will be investigated in this study. In particular, this study will evaluate the effect of~     this combination on kidney cancer and will also examine the safety and side effects of IL-2~     with Zoledronic acid.~   "
227305|NCT00582218|"~     The purpose of this study is to find ways to get services to families living with HIV. New~     services for families living with HIV have been tried in places around the country. They seem~     to benefit many families. We will work with places in New York City that provide HIV services~     to find out more about family services. There, we will talk with people living with HIV,~     their family members, and their providers. Many questions need to be answered. For example:~     What kinds of services do families want? What would make it easier for families to come in~     for services? What would get in the way?~   "
227264|NCT00582764|"~     The purpose of this study is to see if dynamic contrast enhanced (DCE) MRI imaging makes it~     possible to distinguish benign conditions of the breast from malignant tumors and provide~     better information than can be obtained with regular MRI. DCE MRI uses a new way of~     collecting and analyzing the images or pictures which provides doctors extra information not~     available with standard imaging methods. This includes information about the blood vessels of~     different breast diseases. Pictures produced this way look just like the regular MRI~     pictures. The DCE MRI adds another imaging sequence (another scan) to the MRI examination~     ordered by your physician to evaluate your breast lesion, thus increasing the exam time~     (extra 10 min). The information gained from doing the new test, the DCE MRI, will not be used~     in your treatment and will not affect the type of care you receive for your breast lesions.~   "
227265|NCT00582751|"~     To compare the volumetric response achieved using semi-automated computer techniques with the~     uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running~     at MSKCC, testing new agents for different types of solid tumors.~   "
227266|NCT00582738|"~     This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in~     liver transplant patients who have a recurrence of hepatitis C viral infection in the~     transplant~   "
227267|NCT00582725|"~     Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin,~     vincristine, and prednisone), with GM-CSF.~   "
227268|NCT00582712|"~     Primary objective is to evaluate the tumor response rate of patients with MTC treated with~     Lithium carbonate~   "
227269|NCT00582699|"~     The purpose of this study is to measure certain specific chemicals in your blood, produced by~     the body in response to a stress, such as having pancreatic cancer. These chemicals are~     called cytokines and the researchers doing this study want to look at the role they may~     play in developing depression.~   "
227270|NCT00582686|"~     The purpose of this study is to compare patient functional outcomes for surgical fixation of~     calcaneus fractures with and without tricortical iliac crest bone grafting~   "
227271|NCT00582673|"~     This study will evaluate the safety and efficacy of administration of AFQ056 in combination~     with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease~     patients.~   "
227272|NCT00582660|"~     The purpose of this study is to assess how effective celecoxib is in limiting production of a~     hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in~     the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression~     of an existing cancer. To answer this question, some subjects are given the new~     investigational drug, and other subjects a placebo. A placebo is a capsule that contains~     inactive ingredients. Only by comparing the response of two subject groups, one receiving~     placebo (inactive), and one receiving celecoxib (active), will we be able to know whether or~     not celecoxib actually works. The outcome we are assessing is the hormone activity before and~     after celecoxib is given.~   "
227273|NCT00582647|"~     Doctors at Memorial Sloan Kettering Cancer Center and at other institutions study normal and~     cancer cells. To study these cells we need to have human tissue, body fluids, and blood. The~     patient will be having or have had a procedure to remove tissue. The doctors would like to~     use some of this tissue. The doctors will use it for laboratory studies on the causes,~     prevention, diagnosis and treatment of sarcoma, gastrointestinal or other intra-abdominal~     cancers. They will only use extra tissue left over after all needed testing has been done.~     They would also like to study components of the immune blood cells and blood serum (the~     liquid portion of the blood). In some patients they will take a blood sample before the~     tissue or body fluid is removed, usually at the same time that other routine pre-procedure~     blood tests are drawn. If thet need more blood, it will be drawn when the patient is seeing~     the doctor anyway. We will not draw more than 50cc (4-5 tablespoons) at any one time. With~     the patient's permission, thet may also send a small portion of the blood and/or a sample of~     the tissue to a repository at the National Cancer Institute. This will be used to identify~     special proteins in the blood or tissue that may be useful for diagnosing cancer. Information~     about the treatment and the response to treatment may be linked to the tissue specimens~     obtained. This information may be important for the research studies that will be done on the~     tissue, body fluid and blood specimens. All of this information will be kept in strictest~     confidence; they will use it only for biomedical research. The patient's name will not be~     used in any report.~   "
227274|NCT00582634|"~     -  To determine if docetaxel and cisplatin can be administered in a dose intense manner in~          the adjuvant setting in resected non-small cell lung cancer~        -  To evaluate the time to progression and overall survival~        -  To evaluate toxicities of this chemotherapy combination in the adjuvant setting~        -  To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in~          patients treated with this regimen~   "
227275|NCT00582621|"~     The purpose of this study is to better understand the genetic causes of Hodgkin's disease (a~     kind of lymphoma) and non-Hodgkin's lymphoma, as well as multiple myeloma, leukemia, and~     related diseases. The doctors have identified the patient because 1) they have had a~     lymphoproliferative disorder such as lymphoma, leukemia, or multiple myeloma, and have a~     family member with one of these disorders or 2) they are a member of a family with a~     lymphoproliferative disorder, including Hodgkin's disease and/or, non-Hodgkin's lymphoma or a~     second cancer after Hodgkin's disease.~   "
227276|NCT00582608|"~     The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in~     finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten~     themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill~     tumors. The antibody 8H9 was made from mouse white cells. The white cells that secrete this~     antibody have been made to live for ever. They manufacture large amounts of 8H9 for patient~     use. Although other monoclonal antibodies have been safely tested in people, the antibody 8H9~     has never been given to a human patient.~   "
227277|NCT00582582|"~     The purpose of this research study is to find out the toxicities of doxercalciferol given in~     combination with docetaxel (Taxotere®), as well as to see how well this combination works in~     the treatment of prostate cancer.~   "
227306|NCT00582205|"~     The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen~     (belly) along with intravenous administration.~   "
227278|NCT00582569|"~     The purpose of this new imaging method is to provide physicians with additional information~     not available with standard imaging methods. This includes information about the make up of~     different breast diseases. Using spectroscopy data, it may be possible to tell the difference~     between benign conditions of the breast from malignant tumors and provide more accurate~     information than can be obtained with regular MRI. Along with the MRI a new method of~     evaluating the images or pictures will be used. This new method is called spectroscopy and is~     used routinely on other parts of the body such as the prostate and brain. Pictures produced~     with this sequence look different than the regular MRI pictures. Performing spectroscopy on a~     1.5T magnet adds another imaging sequence (another scan) to the routine MRI protocol, thus~     increasing exam time (extra 10-15 minutes). This study will enroll patients who are scheduled~     for a Magnetic Resonance Imaging (MRI) examination ordered by their primary physician.~   "
227279|NCT00582556|"~     The purpose of this research is to determine the effect of timing of Zometa® administration~     on bone mineral density of the lumbar spine and femoral neck in men undergoing androgen~     deprivation therapy for prostate adenocarcinoma. In addition, the researchers will also~     determine the effects of treatment with Zometa® on peripheral blood markers of bone turnover,~     on peripheral blood gd T-cell frequencies and function, and to determine if the above~     treatments elicit prostate antigen-specific IgG immune responses. The effects of the above~     treatments on serial serum PSA measurements will also be examined.~   "
227280|NCT00582543|"~     The purpose of this study is to see if magnetic resonance imaging (MRI) and magnetic~     resonance spectroscopic imaging (MRSI) can tell which patients with prostate cancer are at a~     low risk for their cancer growing and spreading. Magnetic resonance methods use magnets and~     radio waves to take pictures of body structure (MRI) and to measure amounts of important~     chemicals within the body (MRSI). This study will look at the structural and chemical~     properties of prostates before undergoing treatment. Hopefully, doctors will be able to use~     this method before making treatment decisions for patients with newly diagnosed cancer of the~     prostate. This study will continue our work to assess the value of MRI/MRSI in addressing~     what is currently one of the greatest clinical challenges in the management of prostate~     cancer: the identification of low-risk organ-confined prostate cancer that can be managed~     expectantly with deferred treatment.~   "
227281|NCT00582530|"~     The purpose of this study is to see if the protein pattern in your blood can predict whether~     or not your prostate tumor is aggressive. We will use a new and very sensitive technique,~     called mass spectroscopy, to measure hundreds of pieces of protein in your blood. A computer~     will make a picture of the protein pattern. We will do this in 500 men before their prostate~     surgery and see if there is a pattern that predicts what the tumor looks like under the~     microscope. We will also check the protein pattern in your blood 6 weeks to 12 months after~     the surgery to see if your pattern changes.~   "
227282|NCT00582517|"~     The purpose of this project is to evaluate the effect of the Compass™ Universal Hinge~     external fixator on the outcome of patients following acute dislocation of the knee~   "
227283|NCT00582504|"~     This study is designed to determine safety of and immune response to Venezuelan Equine~     Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).~   "
227284|NCT00582491|"~     Subjects participating in this protocol will participate in three phases: 1) pre-admission,~     2) inpatient admission, and 3) follow-up. Pre-admission involves screening (detailed in~     inclusion/exclusion criteria section) and one week of outpatient sleep and activity~     monitoring. Inpatient admission is 16 consecutive nights on the Clinical Neuroscience~     Research Unit and involves subjective and objective tests of sleep, sleepiness, attention,~     and learning. During inpatient admission subjects will take modafinil or placebo. For~     follow-up, subjects will return to the CNRU for one night and again participate in objective~     tests of sleep, sleepiness, attention, and learning. We hypothesize that modafinil will~     decrease subject and objective measures of sleepiness and will promote attention and learning~     in cocaine dependent persons.~   "
227285|NCT00582478|"~     The purpose of this study is to look at how breast cancer treatment affects quality of life~     in women of different ages. The U.S. Army Breast Cancer Research Program funds this study. In~     this research project, we wish to study a woman's quality of life after breast cancer~     treatment as related to her health. We want to know how you feel about your quality of life.~   "
227286|NCT00582465|"~     This is a study to determine if people with Lupus have weak bones.~      Test which is a better method for detecting bone changes:~        -  Dual energy X-ray absorptiometry (DXA)~        -  Single energy quantitative computed tomography (SEQCT)~      Evaluate whether weak bones are associated with things like medications or amount of fat and~     muscle.~   "
227287|NCT00582452|"~     The purpose of this study is to learn more about individual's with a family history of colon~     cancer and the process by which they may decide to undergo or not undergo prophylactic~     colectomy. This is a surgery to remove the colon in order to reduce risk of cancer (or of~     getting cancer again).~   "
227288|NCT00582439|"~     This study is to determine the composition of bone graft harvested using the RIA system in 16~     orthopaedic trauma patients between age 19 and 65 who have sustained a fracture or non-union~     requiring bone grafting. The patients will be followed to assess clinical outcomes and~     associated pain.~   "
227289|NCT00582426|"~     This study will evaluate the efficacy of Octreotide LAR in preventing chemotherapy-induced~     diarrhea (with regimens that contain 5 fluorouracil, irinotecan and capecitabine)in patients~     with colorectal cancer.~   "
227290|NCT00582413|"~     The purpose of this study is to learn more about the quality of life and emotional changes~     that patients experience during their treatment for cancer of the mouth. We want to learn~     more about the emotional and quality of life problems that occur during and after treatment.~     This will help us better understand these complex issues and improve treatment.~   "
227291|NCT00582400|"~     The purpose of this study is: evaluate the safety and activity of administering arsenic~     trioxide (Trisenox) in the treatment of unresectable or metastatic primary liver cancer, to~     evaluate the qualitative and quantitative toxicities of this treatment, and to measure the~     response to treatment and the patterns of failure and survival. The primary response~     measurements will be the achievement of an objective tumor response, response duration and~     progression-free survival~   "
245967|NCT00333879|"~     This is a two-year proof-of-concept study to evaluate a new Virtual Reality (VR)~     holographic sound system for use as an audiological Orientation and Mobility (O&M) training~     tool~   "
227292|NCT00582387|"~     The purpose of the study is to see if we will be more able to tell what the risk is for~     bladder cancer to reoccur or worsen when genetics and risk factors are examined along with~     the stage and grade of the tumor. Superficial bladder cancer is a cancer that does not grow~     into the muscle layer of the bladder wall. Even though it is a superficial cancer, this type~     of cancer tends to come back after being treated and is often more aggressive when it~     returns. We already know, that the stage or how deeply the tumor grows into the bladder~     wall and the grade or how fast the tumor grows affect whether the tumor will come back or~     get worse over time. Now we use information about the stage and grade of your tumor to decide~     how to treat the tumor and how often you should be checked after the treatment is over.~     However, this has not been very reliable, because each person has unique genetic~     characteristics and other factors that are likely to affect what happens to the tumor over~     time. For instance, we know the risk for developing a cancer may be affected by your~     surroundings and other factors such as what you eat, the type of habits you have such as~     smoking, and the type of job you have, but not everyone exposed to the same risk factors gets~     a cancer. We believe this is due to unique genetic characteristics in each person which may~     help their body fight cancer.~   "
227293|NCT00582374|"~     To determine the relationship between periodontal disease and upper genital tract~     inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and~     the vagina are associated with preterm birth or low-birth weight.~   "
227294|NCT00582361|"~     This project is designed as a prospective, randomized, comparative study evaluating the use~     of a negative pressure vacuum device in treating traumatic wounds sustained associated with~     an open fracture.~   "
227295|NCT00582348|"~     The purpose of this study is to learn how often lung cancer survivors exercise. We also want~     to learn what helps people to be active or prevents them from being active. Learning this~     will help us to expand services for lung cancer survivors.~   "
227296|NCT00582335|"~     The purpose of this study is to define new genes for family risks of developing colon cancer.~   "
227297|NCT00582322|"~     The purpose of this study is to determine the specific genetic alterations associated with~     breast cancer. This will leat to a better understanding of the genetic causes of breast~     cancer.~   "
227298|NCT00582309|"~     Increasing evidence from observational studies in hospitalized patients with and without~     diabetes indicates that hyperglycemia is a predictor of poor outcome. Over the short-term,~     hyperglycemia can adversely affects fluid balance (through glycosuria and dehydration),~     impairs immunologic response to infection, and promotes inflammation and endothelial~     dysfunction. Blood glucose control with intensive insulin therapy in patients with acute~     critical illness reduces the risk of multiorgan failure and systemic infections, and~     decreases short- and long-term mortality .~      - Hypotheses: we hypothesize that management of inpatient hyperglycemia with a~     computer-guided intravenous infusion protocol (Glucommander) will facilitate a smoother~     glycemic control with a lower rate of hypoglycemic events than treatment following a standard~     insulin infusion algorithm or a simple calculated infusion protocol in critically ill~     patients in the medical and surgical ICU.~   "
227299|NCT00582296|"~     The purpose of this study is to examine how people with a family history of colon cancer and~     other related cancers respond to recommendations for cancer screening after genetic~     counseling. The purpose of your participation would be to help us learn more about whether~     people with a personal and/or family history of colorectal cancer and other cancers follow~     cancer screening recommendations.~   "
227300|NCT00582283|"~     This study seeks to determine imaging characteristics of radiolabelled 131-I-NM404 in ten~     patients with cancer, including calculations of PKs, radiation dosimetry, biodistribution,~     and optimal imaging times (part 1 - complete).~      In addition, specific tumor accumulation and metabolic fate of 131-I-NM404 will be determined~     in NSCLC tumors collected in 5 patients (part 2 - complete). Lastly, the study will collect~     preliminary data on imaging NSCLC tumors in up to 12 patients with evaluable disease (part 3~     - ongoing).~   "
227301|NCT00582270|"~     The purpose of this study is to determine if an infectious disease may be associated with the~     new lymphoma diagnosis.~      Infections to be tested include:~        1. Helicobacter pylori (H. pylori): This is a bacteria sometimes found in the stomach that~          has been associated with a particular kind of lymphoma, gastric MALT. We are interested~          to learn if the H. pylori infection may be associated with other indolent lymphomas.~        2. Hepatitis C: This virus infection of the liver has been found in association with~          non-follicular lymphomas in Italy. We want to determine if the infection is associated~          with lymphomas in the United States.~        3. Bacterial overgrowth of the small bowel: Since indolent lymphomas often affect the lymph~          nodes surrounding the small bowel, it may be possible that an infection within the bowel~          is stimulating lymphoma growth. This has never been demonstrated to date, and will be~          studied in this clinical study.~        4. Epstein-Barr virus: This is the virus that causes infectious mononucleosis or mono. It~          has been associated with other rapidly growing lymphomas, but not indolent lymphoma.~   "
227302|NCT00582257|"~     The purpose of this study is to establish a gastric cancer registry. A registry is a database~     of information. With the registry, we can learn more about the genetic causes of gastric~     cancer in order to develop better methods of early diagnosis, prevention, and treatment of~     gastric cancers. As part of this study, you will be asked to join a registry of families who~     are affected with various forms of gastric cancer. These registries are important because~     they may help physicians better manage gastric cancer now and in the future. Participating in~     the Early Onset and Familial Gastric Cancer Registry can also be educational for families,~     since it will provide important information to patients, families, and physicians. All of~     this will help to further our understanding of genetic causes of gastric cancer and~     eventually, help determine better ways to diagnose, treat, and survey patients with gastric~     cancer and people who may have a higher risk for gastric cancer.~   "
227303|NCT00582244|"~     Background: Breast cancer is the most common form of cancer among women in the Netherlands.~     Approximately 11,000 women are diagnosed with breast cancer annually, of whom about 30% are~     below 50 years of age. Premenopausal women with breast cancer treated with chemotherapy or~     hormonal therapy may experience a premature onset of the menopause. Estrogen deficiency~     following adjuvant treatments leads to primary endocrine symptoms, including vasomotor and~     urogenital problems. Secondary symptoms include insomnia due to night sweats, dyspareunia due~     to vaginal dryness, weight gain, and psychological distress. The symptoms resulting from~     accelerated estrogen withdrawal can be pronounced and severe, and may adversely affect~     women's sexual functioning, body image, and overall HRQL. Healthy women who enter natural~     menopause are often prescribed hormone replacement therapy (HRT) to alleviate vasomotor and~     sexual symptoms. However, due to possible tumor-promoting effects, HRT is contraindicated for~     patients with a history of breast cancer. For these women, non-hormonal medications are~     frequently prescribed to treat vasomotor symptoms. Although these medications have been shown~     to yield moderate symptom relief, they also have a number of bothersome side effects. To~     alleviate urogenital symptoms, local vaginal moisturizing or estrogen cream is often~     prescribed. There is growing evidence that cognitive behavioral therapy (CBT) including~     relaxation techniques, and physical exercise may effectively reduce vasomotor symptoms in~     naturally occurring menopause. CBT and relaxation techniques are aimed primarily at the~     modification of precipitants of hot flushes and at stress management. Physical exercise on a~     regular basis affects neurotransmitters, which regulate central thermoregulation.~      Purpose: The proposed study will evaluate the efficacy of a supportive intervention program~     in alleviating menopausal symptoms, improving sexual functioning and enhancing the quality of~     life of younger women (< 50 years) with breast cancer who have become prematurely menopausal~     as a result of their treatment. Specifically, the study will evaluate CBT including~     relaxation (A), physical exercise (B), and a combination of A and B.~      Plan of investigation: This multicenter study will employ a prospective, full-factorial~     design. In total, 325 consenting women will be randomized to group A, group B, group AB or a~     usual care, 'waiting list' control group (N = 81-81 per group). Upon completion of the study,~     the patients assigned to the control group will be given the opportunity to undergo either~     the A or B intervention program. The program will begin with a structured assessment of the~     target symptoms: hot flushes, night sweating and vaginal dryness. The overriding goal of the~     intervention is to provide symptomatic women with information skills and support to manage~     their symptoms more effectively. For group A, the intervention will consist of 6 weekly group~     CBT sessions of 1.5 hours, of 15 minutes of daily homework and a booster session at 3 months.~     The CBT will focus on understanding and self-control of menopausal symptoms. Relaxation~     techniques (paced respiration and muscle relaxation) will focus on the reduction of~     sympathetic nervous system activity, and are expected to have a positive impact on the~     frequency and intensity of hot flushes. For group B, the intervention will be an individually~     tailored, 12 week home-based physical exercise program of 2.5-3 hours per week, with~     instructions provided in-clinic on 2 occasions, and telephone support on 2 additional,~     interim occasions. The physical exercise program is intended to enhance fitness levels, in~     general, and to improve thermoregulation specifically related to hot flushes. Group AB will~     receive both the CBT and exercise program elements. Women allocated to the intervention~     groups will be asked to complete a battery of questionnaires assessing menopausal symptoms~     (the primary outcome), sexuality, body- and self-image, psychological distress and generic~     HRQL prior to the start of the program (baseline, T0), at 12 weeks (T1) and at 6 months~     follow-up (T2). Women allocated to the control group will complete the same questionnaire~     battery at parallel points in time.~      Results/ relevance: If demonstrated to be effective, the availability of a structured~     supportive intervention program (modules A, B or AB) will be a welcome addition to regular~     medical care offered to breast cancer patients with treatment-induced menopause. It is~     anticipated that such a program will have direct benefit in terms of symptoms relief and the~     improvement of patients' HRQL.~   "
227304|NCT00582231|"~     The purpose of this study is to help us understand more about your experience with penile~     injection therapy. Many men become anxious when thinking about penile injections. We would~     like to understand more about this anxiety. You will be asked to fill out questionnaires~     before you start penile injection training, at each training visit, and then at your four~     month follow-up visit.~   "
227307|NCT00582192|"~     The purpose of this study is to examine doctor-patient communication about treatment options~     which may include an experimental, new treatment for cancer. What we learn from this study~     may help us to teach doctors better ways to talk to their patients.~   "
227308|NCT00582179|"~     This project is designed as a prospective, randomized, comparative study evaluating the use~     of a negative pressure vacuum device in treating draining hematomas following traumatic~     injury.~   "
227309|NCT00582166|"~     Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab~     consolidation and maintenance therapy every 3 months until disease progression~   "
227310|NCT00582140|"~     The investigators are trying to find new methods to treat prostate cancer. The approach they~     investigators are taking is to try to enhance patients own immune response against the~     cancer. In this study the investigators will be testing the safety of a vaccine that may be~     able to help the body fight prostate cancer.~   "
227311|NCT00582127|"~     This study will evaluate a handheld event-related potential (ERP) testing device from~     Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting.~      An ERP system records electrical signals at the scalp that are produced by the brain when~     performing cognitive tasks. By doing this study, we hope to evaluate various performance~     parameters of the COGNISION(TM) system.~   "
227312|NCT00582114|"~     We will directly test the hypothesis that an initial strategy of lisinopril-based therapy~     will be more effective than atenolol-based therapy in causing regression of left ventricular~     hypertrophy (LVH) over one year in patients with hemodialysis hypertension despite similar~     degree of BP reduction.~   "
227313|NCT00582101|"~     The proposed project will develop and test an HIV prevention intervention for Latino~     families. This study will:~        1. Conduct a pilot run-through of an adapted family-based intervention with three cohorts~          (about 24 families) to determine the feasibility, acceptability, and appropriateness for~          the target population.~        2. Revise the family-based HIV prevention intervention based on the results of the pilot~          run-through and structured exit interviews.~        3. Recruit and randomize 100 families into the Latino family-based HIV prevention~          intervention or a general health promotion condition.~        4. Estimate the effect size of the Latino family-based HIV prevention intervention from~          assessment of changes in HIV-related sexual behavior and attitudes and parental~          monitoring/supervision over 6 months.~      Based on a thorough review of the literature, the following is anticipated:~        1. The revised intervention will be feasible, acceptable, and appropriate for Latino~          families and will be enthusiastically received.~        2. The family-based HIV prevention intervention will result in safer adolescent sexual~          behavior, greater change with regard to primary outcome measures of behavior (recent~          sexual activity, the number of unprotected sex acts, proportion of condom use, and~          intentions to use condoms), safer HIV-related attitudes, improved parent-child~          communication skills, and greater parental monitoring than the Latino families in the~          general health promotion condition.~   "
227314|NCT00582088|"~     The study is designed to assess the safety and immunogenicity of Venezuelan Equine~     Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.~   "
227315|NCT00582075|"~     The protocol is designed to determine the efficacy of temozolomide in preventing the~     development of new brain metastases within the first year in patients undergoing stereotactic~     radiation for newly diagnosed brain metastases.~   "
227316|NCT00582062|"~     We are undertaking a study of patients with gastric or pancreatic cancer. A common place for~     cancer to return after surgery for gastric or pancreatic cancer is the inside lining of the~     abdomen, called peritoneal metastasis. At the time of surgery, washing the abdomen with a~     mild salt solution may reveal free cancer cells in the abdomen which could develop into~     peritoneal metastasis. Recently, surgeons here at Memorial Sloan-Kettering have found that~     patients who have these cells develop peritoneal metastases and are better treated with~     chemotherapy rather than surgery. Sometimes, though, these cells might be present but cannot~     be found by using current techniques. We are trying to figure out a better way to find these~     free cancer cells. This could improve our treatment of patients with gastric and pancreatic~     cancer. We need negative control population to which we can compare the peritoneal washings~     of these cancer patients.~   "
227317|NCT00582049|"~     The purpose of the research study is to learn more about the causes of retinoblastoma and to~     identify possible risk factors in the parents of patients with retinoblastoma. This kind of~     study is called an epidemiology study and is often done by interviewing people with and~     without the disease. In the case of a childhood disease, the researchers ask about~     experiences of the parents and children before the disease developed.~   "
227318|NCT00582036|"~     To determine whether intensive glucose control results in improved mortality and reduced~     hospital stay length by performing a randomized trial of intensive glucose management (blood~     glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose~     management (goal 200 mg/dl)~   "
227319|NCT00582023|"~     The purpose of this study is to examine the role of emotion and mood in the context of HIV.~   "
227320|NCT00582010|"~     This blinded, placebo-controlled study will administer inhaled nitric oxide to patients~     undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide~     prevents liver injury associated with the restoration of blood flow. The premise of the~     current study is provided by previous studies which document a protective effect of inhaled~     nitric oxide in this clinical setting.~   "
227321|NCT00581997|"~     This study will evaluate the safety, tolerability, and mechanism of action of multiple doses~     of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis~   "
227322|NCT00581984|"~     This study will collect 5 year data about any possible health problems associated with breast~     implants. This data will be used to help see if the implants are both safe and effective. If~     they are proven safe and effective, they will continue to be available. If they are not~     proven safe and effective to the satisfaction of the FDA, they may not be available in the~     future.~   "
227323|NCT00581971|"~     This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib~     administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients~     with locally advanced or recurrent squamous cell carcinoma of the head and neck.~   "
227324|NCT00581958|"~     The purpose of this study is to develop blood tests and urine tests that can tell doctors how~     much radiation a person has been exposed to. Doctors know how much radiation patients are~     exposed to in certain medical situations. An example of this would be radiation treatment for~     cancer. Radiation treatment machines are programmed to give exact doses of radiation.~   "
227325|NCT00581945|"~     Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab~     (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function~     in patients with COPD~   "
227326|NCT00581932|"~     This is a study designed to identify genetic polymorphisms (also called allelic variants or~     genetic markers) that are associated with response to clozapine. This information will be~     used to enhance the understanding of clozapine response and side effects. DNA from patients~     will be examined for significant associations between allelic variants in candidate genes in~     relation to clozapine effects on positive and negative symptoms, global response, quality of~     life, relapse rates and side effects.~   "
227327|NCT00581919|"~     Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of~     4 to 8 times (based on response to the treatment). Patients will also receive~     acetyl-L-carnitine (ALCAR) daily.~   "
227328|NCT00581906|"~     Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the~     body using magnetic field and radio frequency pulses that can not be felt. Dynamic contrast~     enhanced-magnetic resonance imaging (DCE-MRI) uses faster imaging and contrast material (a~     substance used to make specific organs, blood vessels, or tumors easier to see) that is given~     by vein. Diffusion weighted magnetic resonance imaging (DW-MRI) allows to measure the motion~     of water around the cells in the tumor. Proton magnetic resonance spectroscopy (MRS) obtains~     chemical information from the tumor. During MRS, signals are detected from the chemicals~     (spectroscopy) naturally present in your tumor using radio waves. DCE-MRI, DW-MRI and MRS~     give extra information which is not available with the regular MRI. The regular MRI only~     shows pictures of the tumor while the DCE-MRI also gives information about the blood vessels~     of the tumor. DW-MRI provides information related to the state of the tumor tissue with~     regards to the quality or condition of cells present in it and MRS gives information about~     the chemical makeup of the tumor.~      The purpose of this study is to see whether DCE-MRI, DW-MRI and MRS done before treatment can~     predict which patients will do well with either surgery or chemo-radiation therapy. This~     study will also see if DCE-MRI, DW-MRI and MRS done early in treatment can tell if the~     therapy is working.~   "
227329|NCT00581893|"~     Automobile driving is a crucial aspect of everyday life, yet vehicular crashes represent a~     serious public health problem. Patients with epilepsy are at elevated risk for automobile~     crashes, causing great personal suffering and financial costs to society. Most collisions~     involving epileptic drivers are not seizure related but may instead result from cognitive~     effects upon driving performance of epilepsy and antiepileptic drugs (AEDs). Several million~     American drivers take AEDs for treatment of medical conditions besides epilepsy and may also~     be at risk for cognitive impairments that can reduce driving performance. Empirical evidence~     of the effects of AEDs on driving performance would enable development of driving guidelines~     that could lower the risk of injurious motor vehicle collisions; however, this evidence is~     currently lacking. The broad goal of our project is to determine the specific effects of the~     most commonly utilized AED, phenytoin, by assessing driving performance and cognitive~     abilities in neurologically normal volunteers taking phenytoin in a randomized, double-blind,~     placebo-controlled, crossover study. Our proposed experiments will assess: (1) cognitive~     functions using standardized neuropsychological tests (of attention, perception, memory, and~     executive functions), (2) driving performance during phenytoin and placebo administration,~     and (3) the effects of phenytoin-related cognitive performance upon driving performance. To~     measure driving performance, we will use a state-of-the-art fixed-base interactive driving~     simulator that allows us to observe driver errors in an environment that is challenging yet~     safe for the driver and tester, under conditions of optimal stimulus and response control.~     The results of this study of 30 drivers treated with phenytoin and placebo will increase the~     understanding of the role of AED-related cognitive impairment on driving safety errors. A~     better understanding of the impact of AEDs upon driving performance is necessary to~     rationally develop interventions that could help prevent crashes by drivers treated with~     AEDs.~   "
227330|NCT00581880|"~     The purpose of this study is to develop an accurate and useful way of measuring patients'~     thoughts and feelings about hope and hopelessness as they relate to their illness. Doctors~     and psychologists from Memorial Sloan-Kettering Cancer Center, Calvary Hospital, the Peter~     MacCallum Cancer Centre, and Fordham University are working together to design a new measure.~     Findings from this research will help us study the nature of illness and develop improved~     methods of diagnosis and treatment. We hope what we learn from you will help us learn more~     about how to care better for patients with cancer and other severe illnesses.~   "
227331|NCT00581867|"~     To determine which parts of the brain are involved in insulin-related memory improvement in~     early Alzheimer's disease and cognitively normal older adults.~   "
227332|NCT00581854|"~     rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by~     rituximab maintenance therapy consisting of four weekly doses every six months for two years~   "
227333|NCT00581841|"~     The purpose of this preliminary substudy to the parent study Aerobic Exercise Intervention~     for Knee Osteoarthritis is to determine the repeatability and reproducibility of various~     measurement techniques.~   "
227334|NCT00581828|"~     The purpose is to perform a one-year study designed to assess whether treatment of~     hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium~     within bone, decreases bone turnover, and favorably impacts upon skeletal muscle mass,~     functional status, measures of physical function and quality of life. I hypothesize that~     treatment of hypovitaminosis D results in improved intestinal calcium absorption, greater~     retention of calcium within the bone reservoir and improved physical function, quality of~     life and muscle mass.~   "
227335|NCT00581815|"~     The purpose of this study is to obtain chemical information from part of your body without a~     biopsy. This is done using a technique called magnetic resonance spectroscopy (MRS) which is~     similar to magnetic resonance imaging (MRI) except that signals are detected from the~     chemicals (spectroscopy) naturally present in your body using radio waves. To receive this~     information from your body, small loops of wire (surface coils), placed near the tissue of~     interest, may be used to more effectively detect signals that come from the chemicals in your~     body. The investigators may use a second radio channel simultaneously, which will allow us to~     obtain greater chemical information (decoupling). The results may also help us to understand~     how this study can be used to help other patients with your condition.~   "
227396|NCT00581022|"~     We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will~     test the null hypothesis that there is no difference in time during the various phases of~     sleep between patients and healthy control subjects.~   "
227336|NCT00581802|"~     The purpose of this observational study is to characterize which immune system cells hide the~     latent reservoir of HIV by counting the number of latent HIV in different subsets of CD4~     cells. Observations will also be made on other possible mechanisms of HIV persistence by~     looking at cellular factors such as APOBEC3 and drug transporters. The purpose of this study~     is to develop new strategies to reduce and possibly eliminate the latent reservoir in HIV~     infected adults.~   "
227337|NCT00581789|"~     -  To determine the safety and maximally tolerated dose of sunitinib plus erlotinib in~          patients with non-small cell lung cancer (NSCLC).~        -  To determine response to sunitinib plus erlotinib in patients with non-small cell lung~          cancer.~   "
227338|NCT00581776|"~     Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine,~     Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4)~     , then one dose of rituximab every 12 weeks until 5 years or disease progression.~   "
227339|NCT00581763|"~     This is a study about why some people have certain types of proteins in their blood, called~     anti-phospholipid antibodies. The presence of these antibodies and associated complications~     (e.g. blood clots) are known to change over time. The purpose of this study is to evaluate~     these changes and improve our ability to determine the long-term outcome of affected~     individuals.~   "
227340|NCT00581750|"~     This study is being done in order to better understand the biology of an abnormal lesion~     found in breast tissue called lobular carcinoma in situ (LCIS). We are interested in~     studying LCIS. The LCIS is not a cancer itself, but is a marker for an increased risk of~     cancer. We would like to look for LCIS in breast tissue removed during surgery from patients~     with cancer or at high risk for cancer. If LCIS is found, we will search for genes that are~     expressed (turned on or off) differently than in normal breast tissue. The identification of~     such genes would help us better understand the biology of LCIS, and its possible relationship~     to breast cancer.~   "
227341|NCT00581737|"~     The purpose of this study is to evaluate several aspects of thinking abilities including~     attention and memory, and quality of life in patients who were diagnosed with and treated for~     Primary CNS Lymphoma (PCNSL), and are in remission of their disease. The findings of this~     study may help us understand whether this disease and its treatment may have affected some~     patients' thinking skills, and may provide important information that can be used to develop~     programs to improve the quality of life of patients with PCNSL.~      This research will also study whether persons having particular types of genes involved in~     the metabolism of methionine (5-methyltetrahydrofolate-homocysteine S-methyltransferase-MTR,~     MTFH reductase-MTFHR, transcobalamin 2-Tc2), and apolipoprotein E (APOE) are more likely to~     have delayed adverse effects after treatment for their tumors. The findings of this study may~     help us understand whether this disease and its treatment may have affected some patients'~     thinking skills, and whether this may be related to having certain genes.~   "
227342|NCT00581724|"~     The purpose of this study is to find out about the pain and quality of life of individuals~     who are adult cancer survivors. By quality of life, we mean how you are feeling about~     different aspects of your life, including your physical health, your emotional health, and~     your ability to carry out daily activities. We are interested in people's opinions about~     their quality of life, as well as the factors that affect their quality of life. In addition,~     learning about pain will help us to develop new services for adult cancer survivors.~   "
227343|NCT00581711|"~     This protocol will prospectively develop a new electronic health record (EHR)-based health~     information technology (IT) intervention that a) summarizes Otitis Media (OM) care into~     clinically meaningful episodes-of-care, b) provides clinical decision support based upon~     evidence-based guidelines to primary care and ENT physicians working within an integrated~     physician network that uses a common EHR, and c) tests the additive effects on quality and~     resource utilization of providing feedback to physicians.~   "
227344|NCT00581698|"~     The purpose of this study is to determine whether we can consistently identify the first~     lymph node (the sentinel node) draining your melanoma.~   "
227345|NCT00581685|"~     Despite the development of new pain medications, the prevalence of persistent postoperative~     pain (for more than three to six months) remains alarmingly high. Chronic pain and reduced~     function after surgery are of great concern since they have a significant impact on a~     patient's quality of life and are costly to society in terms of longer hospital stays and~     lost work days. An important risk factor for chronic pain and reduced function after surgery~     is the amount of pain patients experience immediately after surgery which is highly~     influenced by the amount of pain patients have preoperatively. For many patients,~     longstanding pain prior to surgery is common and thus can compromise the outcome of the~     procedure. Therefore, the aim of this study is to reduce the amount of pain patients have~     before they undergo surgery by administering a novel pain-relieving regimen in the weeks~     before surgery. Crucially, this treatment will be continued for three weeks after surgery to~     reduce pain that arises from the surgical trauma. The novel regimen will include a~     non-steroidal anti-inflammatory (celecoxib) and the alpha2 delta ligand, pregabalin. This~     drug combination will provide the best opportunity to target several key sites in the pain~     pathway. This regimen will be tested in patients with pain related to osteoarthritis and who~     are undergoing orthopedic (hip) surgery because chronic preoperative pain is common in these~     patients and is the main reason for undergoing surgery. The goal of this research proposal is~     to adequately manage pain before and after surgery in order to improve function weeks after~     surgery. If controlling pain in this way does lead to improved long term postoperative~     function the findings from this study may lead to the development of a standardized regimen.~     This is highly relevant not only for orthopedic procedures but following other common~     surgical procedures which would be of great benefit to patients and the entire healthcare~     system.~   "
227346|NCT00581672|"~     This study is being done to see if a standard tool used to check anxiety in white men works~     well for Black men. The tool is used only for men who have prostate cancer. It is meant to~     see how the cancer affects men. If the investigators have a good tool, it is more likely that~     the investigators can help those who have high levels of anxiety. This test is known as the~     Memorial Anxiety Scale for Prostate Cancer (also called the MAX-PC).~   "
227347|NCT00581659|"~     The objective of this study is to quantify differences in nighttime driving performance~     between the Bausch & Lomb PureVision™ aspheric contact lenses and a conventional spherical~     contact lens.~      The primary aims of this study are to determine the differences between B&L PureVision™~     aspheric contact lenses and a conventional spherical contact lens in visual performance~     measures associated with driving, such as number of objects seen.~      The secondary aims of this study are to determine differences between B&L PureVision™~     aspheric contact lenses and a conventional spherical contact lens in driving performance~     measures such as number of objects hit.~   "
227548|NCT00579007|"~     The purpose of this study is to learn more about women's decision to undergo prophylactic~     surgery. This is removal of healthy organs in order to reduce risk of cancer. This study will~     help us to understand what makes women decide whether or not to have this kind of surgery.~   "
227348|NCT00581646|"~     This study aims to learn about the needs and feelings of women who are infertile. Being~     infertile means not being able to have a child without the help of a third party. There are~     other options for building a family. The researchers are interested in the participants'~     thoughts about these options and want to learn about the experiences of infertile women due~     to cancer treatment as well as women who are infertile due to other causes. The researchers~     hope that what they learn will allow them to better care for infertile women in the future.~   "
227349|NCT00581633|"~     The investigators will test the hypothesis that patients with chronic orthostatic intolerance~     or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary~     sodium as compared to healthy control subjects.~   "
227350|NCT00581620|"~     To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with~     immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.~   "
227351|NCT00581607|"~     Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary~     hypertension is a condition where the right side of the heart has to push the blood though~     the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for~     the heart to pump the blood through the lungs to the left side of the body. If the blood can~     not get through the lungs, it can not get pumped through the rest of the body. This leads to~     weakness and shortness of breath. This type of hypertension does not usually respond to~     regular blood pressure medicines. The purpose of this study is to determine if bosentan~     (Tracleer) will help sarcoidosis associated pulmonary hypertension.~   "
227352|NCT00581594|"~     Women who undergo posterior colporrhaphy with graft augmentation will have a lower recurrence~     of their posterior wall defect than women who undergo a traditional posterior colporrhaphy.~   "
227353|NCT00581581|"~     This observational study will assess long-term functional outcome of survivors from neonatal~     encephalopathy who were previously treated with either head cooling or with conventional care~     in a randomized clinical trial. Children's parents will be interviewed by phone by trained~     staff using the WeeFIM questionnaire to ascertain the childrens' functional performance on a~     set of skills basic to daily life. This instrument is able to assess a very wide range of~     abilities, from independently functioning to needing total assistance. The ratings will be~     used to examine the relationship between the outcome previously measured at 18 months age and~     functional outcome at school age and to triage the children into those who clearly could not~     be tested on standardized exams of cognitive functioning, those who potentially could, even~     if at a low level of cognitive ability, and those who appear to be functioning at an~     age-appropriate level.~   "
227354|NCT00581568|"~     Cryogen Spray Cooling spurt is applied to the skin surface immediately before laser exposure.~     As liquid cryogen rapidly evaporates, the superficial skin temperature is reduced as a result~     of supplying the latent heat of vaporization. Tetrafluoroethane, an environmentally~     compatible, non-toxic, non-flammable freon substitute, has been demonstrated in multiple~     studies to be a safe and effective cooling agent and is the only cryogenic compound currently~     approved for dermatologic use by the Food and Drug Administration.~   "
227355|NCT00581555|"~     The purpose of this study is to evaluate the use of etanercept as a replacement therapy for~     ciclosporin in patients with plaque psoriasis.~   "
227356|NCT00581542|"~     The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and~     Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications~     are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study~     will investigate if both of the medications are equally good.~   "
227357|NCT00581529|"~     This is a phase I- II feasibility study for delivering partial breast irradiation (PBI) in~     selected patients with early stage, lymph node negative, breast cancer after~     breast-conserving surgery using accelerated Intensity Modulated Radiotherapy (IMRT).~   "
227358|NCT00581516|"~     Prostate cancer is the second leading cause of cancer related deaths among men in the United~     States.1 Although still controversial, there is growing evidence that early detection will~     reduce prostate cancer mortality. Currently the most useful biomarker to aid in early~     detection is measurement of serum prostate specific antigen (PSA) levels. Despite the value~     of PSA it has substantial limitations. To overcome the limitations of total PSA testing,~     there is emerging evidence demonstrating that relevant cancer biomarker can be detected in~     urine.~      Patients who present to the urology clinic for a radical prostatectomy will be asked to enter~     this study. After obtaining informed consent, the following exam and specimen collection~     scheduled will be followed:~      Visit 1 (pre-op):~      Digital Rectal Exam (DRE) - Voided urine collection & serum collection~      Visit 2 (time of prostatectomy):~      Under anesthesia- catheterized urine collection and serum collection~      Visit 3 (approximately 8 days post-prostatectomy):~      Catheterized urine collection~      Visit 4 (approximately 3 months post-prostatectomy):~      Voided urine collection and serum collection~      Some patients will not have the serum collection at visits 1, 2, and 4. The patients will be~     notified as to whether or not their blood will be drawn during the visits. Pre-operative~     Digital Rectal Exam, urinary catheterization and blood draws are part of standard of care in~     this patient population with localized prostate cancer. The catheter will be inserted during~     the time of surgery preparation in the operating room and removed during the post operative~     clinic appointment.~   "
227359|NCT00581503|"~     This study has been designed to utilize already obtained biopsy specimens for investigation~     of the utility of a new, non-invasive optical diagnostic technique. The study will allow a~     careful correlation between the Optical coherence tomography findings and conventional~     histology.~   "
227360|NCT00581490|"~     Children with premature pubarche will have radiological and radial artery tonometry evidence~     of cardiovascular morbidity at diagnosis when compared to matched controls.~   "
227361|NCT00581477|"~     The purpose of this study is to try different medications in patients with low blood pressure~     and other problems with their involuntary (autonomic) nervous system. The pharmacological~     trials in this study will perhaps lead to more effective treatment. This study consists of~     single dose trials, dose selection trials, 5-day trials and chronic (approximately 2 months)~     trials.~   "
227549|NCT00578994|"~     The purpose of this study is to collect information on complications and survivorship of~     patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites~     in the United States.~   "
227362|NCT00581464|"~     80 nicotine dependent adults ages 18-65 who desire to quit smoking will be screened and, if~     eligible, enrolled and randomized to one of two four-week treatments for smoking cessation.~     The treatments are standard behavioral therapy and Mindfulness Based Addiction Therapy~     (MBAT), which is standard therapy plus mindfulness. Standard therapy and MBAT incorporate~     elements of widely-used tools for smoking cessation including managing craving and strong~     emotions, problem solving, tips on healthy eating and keeping active, and exercises based on~     cognitive and behavioral therapy. MBAT uniquely incorporates mindfulness practice (a~     relaxation therapy) into standard therapy. Participants complete questionnaires and undergo~     an fMRI scan at baseline and at the end of therapy (after they complete the 4 weeks of~     standard therapy or MBAT). During each scan, participants will complete a validated~     smoking-related cue paradigm and a validated affect labeling paradigm.~   "
227363|NCT00581451|"~     Safety and tolerability study in healthy volunteers~   "
227364|NCT00581438|"~     Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual~     clinical practice conditions in Spain.~   "
227365|NCT00581425|"~     A trial to see if BCC excluding the scalp and face can be treated successfully with a~     combination therapy of Intron-A and Aldara.~   "
227366|NCT00581412|"~     This study is to determine whether the use of a composite biologic/synthetic graft during~     abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.~   "
227367|NCT00581399|"~     The purpose of this study is to compare a new high vacuum pressure chest drainage system~     (NO-NUMO™) with the standard low vacuum pressure drainage system already in use in cardiac~     surgeries. The new system uses smaller diameter drainage tubing to remove blood from the~     chest after open heart surgery. This is less painful to the patient and should help the~     patient to breathe better after operation. Preliminary data suggests that the high vacuum~     suction is effective and practical, and could actually reduce the amount of chest tube~     bleeding after surgery without compromising heart function. This new high vacuum drainage~     system was approved by the FDA in 2002. Subsequent testing at University of California,~     Irvine indicated that this unique system may allow the surgeon to predict excessive~     postoperative bleeding before the patient is transferred out of the operating room, thus~     adding safety, convenience, and cost effectiveness to their use.~   "
227368|NCT00581386|"~     The purpose of this study is to evaluate a new supra-glottic airway device, the Disposable~     Laryngeal Tube Suction (LTS-D; King Systems, Noblesville, IN). We propose to test its ease~     of insertion, position within the airway, patency of drain tube and anatomic sealing~     properties during spontaneous ventilation in anesthetized patients. The study device will be~     compared to the ProSeal Laryngeal Mask Airway (PLMA, LMA North America Inc.) and the~     Esophageal Tracheal Combitube (ETC; Tyco Healthcare/Mallinckrodt Nellcor, Pleasanton, Calif).~   "
227369|NCT00581373|"~     We will test the null hypothesis that there is no diurnal (morning to afternoon)variability~     in the blood pressure response to the ingestion of water 16 oz.~   "
227370|NCT00581360|"~     This is a Phase II trial non-randomized study to evaluate the objective response rate and~     stable disease rate (primary endpoints), progression-free survival, overall survival and~     toxicities with the combination of doxorubicin and bortezomib in patients with incurable head~     and neck adenoid cystic carcinoma. Also, we plan to collect tumor tissue from previous~     diagnostic procedures and baseline blood specimens for future correlative studies.~   "
227371|NCT00581347|"~     This study will examine whether the implementation of an outreach program that employs a~     tracking/reminder/recall/home visiting strategy will have any impact on receipt of~     immunizations and preventive care among urban adolescents.~   "
227372|NCT00581334|"~     Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical~     prolapse repair of the vagina.~   "
227373|NCT00581321|"~     In this study the investigators propose to assess the hemodynamic response to the ingestion~     of 16 fl oz of water. The investigators will test the hypothesis that water ingestion will~     increase the systemic vascular resistance.~   "
227374|NCT00581308|"~     The purpose of this study is to evaluate the long-term safety and efficacy of the GORE®~     HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).~   "
227375|NCT00581295|"~     Trauma remains the leading cause of death and disability for Americans age 1-44. Trauma can~     cause internal bleeding, and this bleeding is often hard to detect without sophisticate tests~     that take time to complete and analyze.~      In addition, internal bleeding, including bleeding into the lung and chest cavity, as well as~     other blood loss, happens in many critically ill patients. For example, for hemorrhage, it is~     very difficult to detect active hemorrhage and to determine optimal rates of fluid and blood~     resuscitation.~      Diffuse optical spectroscopy has the potential to accurately assess adequacy of tissue~     perfusion, oxygenation, tissue oxygen extraction, and cytochrome oxidation states that may be~     critical to optimal treatment, end- organ preservation, and survival.~   "
227376|NCT00581282|"~     This study evaluates theories regarding cocaine abstinence which propose that increased~     presynaptic and postsynaptic dopamine activity and increased serotonin activity are~     associated with abstinence in cocaine dependent subjects at the beginning and three to six~     months after a treatment program. We are using positron emission tomography (PET), Magnetic~     Resonance Imaging (MRI) and diffusion tensor imaging (DTI) in cortical and subcortical areas~     in a series of brain imaging studies testing these theories of abnormalities in the dopamine~     and serotonin system for cocaine addiction by examining the distribution of 18F-fallypride,~     18F-altanserin, and FDG. We are evaluating genetic theories associated with cocaine addiction~     through the examination of genetic markers and functional genomics.~   "
227397|NCT00581009|"~     This study evaluates the efficacy of sleep deprivation treatment in accelerating~     antidepressant responses when administered during the first week of medications and~     augmenting a sustained response with chronobiological interventions. Sleep deprivation and~     chronobiological augmentation may offer a rapid and sustained antidepressant response in mood~     disorder patients treated with medication, sleep deprivation, bright light therapy and sleep~     phase advance compared with medication only. The chronobiological treatment is rapid,~     non-invasive and has few side effects and could be of significant clinical benefit.~   "
230298|NCT00542113|"~     The purpose of this study was to evaluate the effectiveness of a school-to-home education~     program for it's ability to increase knowledge about, and ability to prevent type two~     diabetes in children and parents.~   "
227377|NCT00581269|"~     The oxidative stress and inflammatory state is known to contribute to the pathogenesis of~     atherosclerosis, and is predictive of cardiovascular events and mortality rates in the~     general population and patients with chronic kidney disease (CKD), particularly in patients~     with end stage renal disease (ESRD) on dialysis therapy 1. Increased oxidative stress and~     inflammation has been identified in all stages of CKD, ranging from moderate renal~     insufficiency to ESRD. However, the pathophysiology of increased oxidative stress and~     inflammation associated with the development of CKD is currently poorly understood.~      There is also concern about the epidemic of obesity in the United States, as the overall~     health status of the general population is adversely affected by increasing adiposity. Recent~     studies indicate a strong relationship between adiposity and incident CKD. Furthermore, the~     presence of an elevated body mass index (BMI) is an independent predictor for progression to~     ESRD, even after additional adjustments for baseline blood pressure and the presence or~     absence of diabetes mellitus. Limited data in the general population show that healthy~     lifestyle interventions, such as exercise and dietary caloric restriction, either alone or in~     combination, reduce the inflammatory and oxidative stress burden seen in obese subjects. The~     impact of healthy lifestyle modifications on inflammation and oxidative stress has not been~     investigated in the obese CKD population. Based on the foregoing observations, the purpose of~     this investigation will be to determine whether healthy lifestyle interventions in the form~     of low-impact aerobic exercise and dietary calorie restriction in obese subjects (BMI ≥~     30kg/m2) with moderate to severe (Stage III-IV) CKD [estimated glomerular filtration rate~     (GFR) 20-59 ml/min] will improve oxidative stress, inflammation, insulin resistance,~     adipocytokines, endothelial dysfunction, and quality of life.~   "
227378|NCT00581256|"~     Radiotherapy has been shown to reduce breast-cancer specific mortality in patients at high~     risk for distant dissemination. It has also been shown to increase rates of non-breast cancer~     deaths and morbidity due to cardiovascular and pulmonary toxicity. Although treatment~     planning has improved significantly through the years, recent reports still demonstrate~     treatment-related morbidity even with 3-dimensional planned techniques. Thus, while 3D~     planning represents the state of the art treatment for loco-regional radiotherapy for breast~     cancer, further improvement is needed to continue to decrease heart and lung exposure. The~     ultimate goal of the proposed research is to determine whether treatment planning using~     intensity-modulated radiotherapy (IMRT), the next generation of radiation treatment~     delivery systems, results in less radiation exposure to the heart and lungs than the best~     current RT technique in women with node positive breast cancer. This proposal will test the~     potential clinical value of IMRT compared to the best standard 3D plan (partially wide~     tangent fields, PWTF) in the treatment of breast cancer. These two treatment techniques will~     be studied in a Phase II randomized trial using quantitative indicators of potential cardiac~     and lung toxicity. The preliminary data generated from this trial will be used to ultimately~     justify a multi-institutional comparison of the two treatment techniques with long-term~     clinical cardiac and pulmonary toxicity as endpoints.~   "
227379|NCT00581243|"~     Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and~     schizoaffective disorder to assess safety and tolerability.~   "
227380|NCT00581230|"~     The purpose of this study is to determine if the Rapid Airway Management Positioner (RAMP,~     AirPal, Center Valley, PA) is a useful positioning device for direct laryngoscopy and~     tracheal intubation in obese patients undergoing gastric bypass or laparoscopic gastric~     banding surgery.~   "
227381|NCT00581217|"~     The research will be looking at patient outcomes for healing of donor sites after a~     split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time,~     infection rate, cosmetic outcome, and patient's rating of pain will be compared between two~     donor site dressings, Glucan II and Aquacel Ag.~   "
227382|NCT00581204|"~     The purpose for this study is to measure the physiology of human undergoing a Lower Body~     Negative Pressure usea non-invasive low-power optical technique, near-infrared diffuse~     optical spectroscopy measurement and compare these measurement to standard monitoring~     procedures delineated in the Brooke Army Medical Center.~      The Brooke Army Medical Center can use near-infrared diffuse optical spectroscopy to provide~     functional physiologic tissue and organ information without ionizing radiation and without~     withdrawing any blood, in a cost-effective and rapid manner. Monitoring for the onset of~     circulatory shock in a wounded soldier on the battlefield is typically performed by~     measurement of arterial blood pressure, arterial oxygen saturation, or simple auscultation of~     the pulse. Shock is typically recognized by non-specific signs and subjective symptoms such~     as cold clammy skin, pallor, weak thready pulse, unstable vital signs, and diminished~     mentation.~   "
227383|NCT00581191|"~     Safety and tolerability of single oral doses in healthy subjects.~   "
227384|NCT00581178|"~     Ureteral stent placement is one of the most common procedures performed within urology. The~     stents are generally placed for relief of obstruction or to prevent obstruction following a~     urological procedure. Most patients with ureteral stents will eventually form stent~     encrustations. However, patients form these encrustations at dramatically different degrees~     and rates ranging from no encrustation at 1 year of stenting to severe encrustation in just a~     few weeks. The purpose of this study is to determine if the degree of encrustation on a stent~     for any given patient can be predicted based on 24 hour urine parameters prior to stent~     placement, with the stent in place and after stent removal.~      Patients who will be receiving stents for other urological reasons will have a 24 hour urine~     sample collected before stent placement, while the stent is in place and after the stent has~     been removed. The parameters examined in the 24 hour urine collected will then be compared to~     the amount of encrustation there is on the stent to see if there is any correlation between~     the two.~   "
227385|NCT00581165|"~     Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain;~     (ii) the incidence of adverse events reported in these patients, and (iii) the role that age~     and concomitant therapy might play in the development of adverse reactions.~   "
227398|NCT00580996|"~     We are studying the effects of oral water ingestion in patients with orthostatic hypotension.~     In this study, we are testing the null hypothesis that the blood pressure increase with oral~     water ingestion will not be diminished if a full prior water dose is given a few hours~     earlier.~   "
227399|NCT00580983|"~     The purpose of this study is to test whether the use of advanced radiation therapy delivery~     techniques can spare a patient's normal tissue, including salivary glands, from radiation.~     This study is being done to try to reduce radiation side effects, especially mouth dryness,~     which happens with standard radiation methods. In order to reduce these side effects, other~     normal tissues may receive a different radiation dose (sometimes more) than what would have~     been received using standard radiation therapy. A secondary goal of this study is to~     determine if the type of tumor a patient has can be controlled at least as well (or better)~     using this advanced radiation therapy delivery technique as it would be if the patient was~     treated with standard radiation therapy.~   "
227386|NCT00581152|"~     Stem cells can develop into every cell, every tissue and every organ in the human body, e.g.,~     they can make any kind of cells in the human body. Stem cells reproduce themselves many times~     over and over. Their almost limitless potential has made stem cells a significant focus of~     medical research. But before scientists can use stem cells for medical purposes, they must~     first learn how to harness their power. They cannot treat disease until they learn how to~     manipulate stem cells to get them to develop into specific tissues or organs.~      We know that turning genes on and off is crucial to the process differentiation, so we can~     add some factor into the culture dish and observe stem cells to differentiate into specific~     types of cells. But some sort of signal is needed to actually trigger the stem cells to~     differentiate. We are still searching for that signal. If we can ultimately learn how to~     direct stem cells to differentiate into one type of tissue or another, then we can use them~     to treat patients. In this proposal, we will first examine this step.~      We propose a novel approach to understanding differentiation of human embryo stem (hES)~     cells, by studying TBX3, a protein called a transcription factor that controls the expression~     of other genes. In humans, the loss of function of TBX3 causes Ulnar-Mammary Syndrome, a~     genetic disorder that can pass from one generation to the next. Furthermore, our preliminary~     results show that TBX3 is downstream mediator of another protein, BMP4. BMP4 is a known key~     regulator for hES cell differentiation. Thus, TBX3 is an attractive candidate as a downstream~     mediator of BMP4 in hES cell differentiation. We will test TBX3 effects on hES cell~     differentiation if down-regulate TBX3 in hES cells with a technology called siRNA knockdown.~     We will identify the genes controlled by TBX3 with a recently invented powerful technology~     called CHIP-GLAS. This technique allows us to examine thousands of genes on a small chip in a~     single experiment. We expect that the innovative experiments proposed here will open a new~     avenue to understanding the signal of hES cell differentiation.~   "
227387|NCT00581139|"~     The primary hypothesis tested in this project is that the preoperative behavioral stress~     response predicts postoperative behavioral and clinical recovery of children undergoing~     surgery.~   "
227388|NCT00581126|"~     To assess efficacy and safety of BeneFix® for prophylaxis in Short-term therapy and on~     demand therapy for all bleeding episodes of subjects with hemophilia B.~   "
227389|NCT00581113|"~     For patients with 1-6 intraparenchymal brain metastases from various primary histologies~     (except for melanoma), stereotactic radiosurgery (administered upfront or concurrently) or~     complete surgical resection with neural stem cell (NSC)-preserving whole-brain radiotherapy~     (WBRT) results in improved neurocognitive profile over standard WBRT. The goal of this study~     is to assess feasibility of this treatment approach.~   "
227390|NCT00581100|"~     The purpose of this study is to evaluate if Etanercept administered at a higher initial dose~     provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower~     initial dose.~   "
227391|NCT00581087|"~     DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic~     hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in~     human. The purpose of this study is to determine if DHEA is effective in the treatment of~     respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease~     (COPD) on exercise capacity and haemodynamic variables. Patients will receive after~     randomization either 200 mg oral DHEA or placebo over a one-year period. Evaluation concerns~     clinical parameters, echocardiography and right catheterization after and before treatment.~     Primary end-point is the six-minute walk test. This is a prospective double blind,~     randomized, placebo controlled study which will be realized in four university hospitals in~     France : Bordeaux, Strasbourg, Toulouse and Limoges.~      Eight patients with pulmonary hypertension (New York Heart Association functional class III~     or IV) associated with COPD were included in a pilot study between 2004 and 2005. Inclusion~     criteria were: COPD was defined by FEV1/FVC < 70% of reference values; resting mean pulmonary~     artery pressure (assessment by right pulmonary catheterization) ≥ 25mmHg with mean pulmonary~     capillary wedge pressure ≤ 15mmHg, PaO2 ≤ 60mmHg at rest or PaO2 ≥ 60mmHg associated with~     significant fall in O2 saturation with exercise; oxygen treatment initiated more than six~     months previously. Exclusion criteria were: clinical or respiratory instability during the~     three months before the inclusion in the study; corticosteroids therapy (> 0.5mg/kg/day of~     prednisolone or as equivalent); hepatic (prothrombin time < 50%) or renal (creatininemia >~     130µmol/L) failure; diabetes; left ventricular dysfunction; PSA (prostatic antigens >~     2,5ng/ml) and past history or diagnosis of cancer. The study was conducted in accordance with~     the Good Clinical Practices Guidelines. The study protocol was approved by the ethics review~     board of the University Hospital of Bordeaux (France). Written informed consent was obtained~     for all patients and investigations were conducted according to the institutional guidelines~     and to the Helsinki principles. This trial conducted enrollment between 2004 and 2005, but~     had not been registered in ClinicalTrials.gov because it preceded this policy.(Study design:~     The dose of oral DHEA administered was 200 mg once daily for three months. At baseline and~     after three months of treatment, clinical evaluation included 6MWT, Borg dyspnea index,~     systolic and diastolic blood pressure, right heart catheterisation, lung function testing and~     serum DHEA levels were performed.)~   "
227392|NCT00581074|"~     This trial examines the effects of grapefruit or grapefruit juice on anthropometry, dietary~     intakes, appetite, and metabolic profile in overweight and obese young and middle-aged~     adults.~   "
227393|NCT00581061|"~     Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading~     cause of death from cancer in men. Radical prostatectomy is one of the treatment options~     available for organ-confined disease. Over 100,000 radical prostatectomies cases (total~     removal of the cancerous prostate by surgery) are performed in the United States yearly.~     Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life~     (QOL) scores due in part due to a postoperative incontinence which may require the use of~     multiple urinary pads per day. Many of these men also report debilitating irritative voiding~     symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction~     scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients~     symptoms may persist for longer periods.~      Our recent published findings suggest that instability in the bladder muscle is likely an~     underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability~     results in excess contractions of the urinary bladder ('urgency to urinate'), and can result~     in the feeling of needing to urinate more frequently. Consistent with this hypothesis of~     detrusor muscle instability, men with postoperative dribbling had more complaints with~     urgency, frequency and bother scores when queried with validated questionnaires. We suspect~     that a transient bladder muscle contraction may overcome the urinary sphincter valve~     resistance and result in the patient's dribbling of urine.~      By treating the bladder muscle instability, we expect improved postoperative continence and~     improved quality of life in patients after undergoing surgery for total removal of a~     cancerous prostate. This pilot study will assess the statistical requirements for the number~     of subjects needed for a fully 'powered' randomized prospective study to fully evaluate~     whether medications such as solifenacin significantly improve patients' quality of urinary~     life and improve postoperative urinary incontinence after surgery.~   "
227394|NCT00581048|"~     Asthma is a common respiratory disease of unknown etiology which currently affects~     approximately 7.5 % of the adult population ( ). Asthma is an inflammatory disorder of the~     airways. Airway inflammation is evident not only in patients with fatal asthma but also in~     mild asthmatics ( ). Oxidant stress, defined as inadequately controlled generation of toxic~     reactive oxygen species (ROS) in the cells or tissues is a common feature of inflammation,~     and has also been documented in asthma ( , ). However, the current understanding of the~     relationship between the inflammation and the oxidant stress in asthmatic airways is poor.~     Does oxidant stress contribute to the expression of asthmatic phenotypes independently of~     inflammation? If so, could asthmatics benefit from supplementation of antioxidants? These~     questions have been nagging us since our laboratory provided credible evidence of oxidant~     injury in the airways of allergic asthmatics ( ). The purpose of our study is to more~     precisely determine 1/ the pathophysiologic role of oxidative stress, and 2/ usefulness of~     antioxidant therapy using vitamin E in allergic asthma.~   "
227395|NCT00581035|"~     The purpose of this study is to evaluate the safety and immunogenicity of concomitant~     Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of~     the routine vaccination series in healthy infants~   "
227401|NCT00580957|"~     The overall goal of this proposal is to determine the role of the autonomic nervous system in~     the insulin resistant state associated with obesity and the metabolic syndrome. Obesity~     results from an accumulation of excessive fat deposit due to increase caloric intake or~     decrease energy expenditure, this condition is usually associated with diseases such as~     hypertension or diabetes, a cluster known as the metabolic syndrome. The first step in the~     development of the metabolic syndrome is a resistance to the action of insulin. The mechanism~     underlying insulin resistance in obesity is still unknown, however some investigators have~     proposed that the autonomic nervous system, particularly the increase sympathetic activation~     in obesity may play an important role. We have extensive experience studying the role of the~     autonomic nervous system in the cardiovascular alterations associated with obesity by~     producing complete autonomic withdrawal with a drug named trimethaphan. We propose to use the~     same approach to study the role of the autonomic nervous system in the development of insulin~     resistance in obesity.~   "
227402|NCT00580944|"~     Port wine stain is a congenital, progressive vascular malformation of skin involving~     post-capillary venules that occurs in an estimated 4 children per 1,000 live births.~     Approximately 1,200,000 individuals in the United States and twenty-six million people~     worldwide have Port wine stain birthmarks.~      Since most of the malformations occur on the face, Port wine stain is a clinically~     significant problem in the majority of patients. Port wine stain should not be considered a~     cosmetic problem but a disease with potentially devastating psychological and physical~     complications. Personality development is adversely influenced in virtually all patients by~     the negative reaction of others to a marked person. Port wine stain are initially flat red~     macules, but lesions tend to darken progressively to purple, and by middle age, often become~     raised as a result of the development of vascular nodules. Hypertrophy of underlying soft~     tissue further disfigures the facial features of many patients.~   "
227403|NCT00580931|"~     The purpose of this study is to determine whether nicotinamide, or vitamin B3, is safe and~     effective in the treatment of Alzheimer's disease.~   "
227404|NCT00580918|"~     The purpose of this study will be to assess the attentional ability of patients with mild to~     moderate traumatic brain injury (TBI) using the functional Magnetic Resonance Imaging (fMRI)~     technique. Methodology for specific aim 1: sagittal pilot scan, 3-D anatomical MRI, Whole~     brain echo-planar imaging (EPI), and functional MRI techniques with traumatic brain injured~     subjects doing a Continuous Performance Test (CPT) attention task and compare the pattern of~     activation with those of normal controls to see if there is a failure to activate frontal~     lobes in the traumatic brain injured subjects.~   "
227405|NCT00580905|"~     The purpose of this study is to extend previous observations in animal models regarding the~     effects of adenosine in the release of cytokines to human subjects. We intend to accomplish~     this in two study protocols. In the first we will infuse intravenously adenosine and measure~     the plasma levels of inflammatory cytokines. In the second one, we will use a microdialysis~     technique to infuse intradermally small amounts of adenosine and will measure skin blood flow~     and will take a biopsy to measure levels of mRNA for cytokines.~   "
227406|NCT00580892|"~     The researcher can use Optical coherence tomography a near-infrared diode to emit light that~     can produce images of the specimen under investigation and provide information about tissue~     abnormalities without causing damage.~   "
227407|NCT00580879|"~     The purpose of this study is to see if fetal head circumference can be used as a predictor~     for who will experience a sphincter laceration while delivering.~   "
227408|NCT00580866|"~     The purpose of this study is to help determine if a static stretching brace in addition to~     physical therapy decreases the incidence of secondary operations, increases range of motion,~     and individual patient function.~   "
227409|NCT00580853|"~     The purpose of this study is to examine how smoking cessation medications (varenicline,~     bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in~     non-treatment seeking daily smokers.~   "
227410|NCT00580840|"~     During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and~     4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and~     16. At Wk 18 patients will be grouped as responders or non-responders based on results of the~     ACR20 at Week 16.~   "
227411|NCT00580827|"~     This 18-week, randomized, double blind clinical trial provided treatment for 160~     cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM~     maintenance during the first 4 weeks and cocaine use was assessed; participants were then~     stratified by level of cocaine use and randomly assigned to receive one of the following:~     placebo disulfiram (0 mg/day), disulfiram at 62.5 mg/day, disulfiram at 125 mg/day, or~     disulfiram at 250 mg/day. During induction onto LAAM, participants were administered~     increasing doses of LAAM plus placebo disulfiram on a thrice-weekly basis until maintenance~     doses of LAAM are attained. At the beginning of week 5, participants received LAAM plus~     disulfiram or placebo disulfiram according to their randomized assignments, and were~     maintained on these agents through week 16. At the end of the study, participants underwent~     detoxification from LAAM and active/placebo medication over a 4- to 6-week period. All~     participants received weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with~     experienced clinicians specifically trained to deliver the therapy and who received ongoing~     supervision. The primary outcomes were retention and reduction in opioid and cocaine use, as~     assessed by self-report and confirmed by thrice-weekly urinalyses. Secondary outcomes~     included reductions in other illicit drug and alcohol use, as well as improvements in~     psychosocial functioning.~   "
227412|NCT00580814|"~     The purpose of the study is to investigate the functional state of dopamine cells and the~     dopamine transporter in ADHD subjects and controls to assess the effects of chronic~     methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD~     subjects.~   "
227413|NCT00580801|"~     The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C~     Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is,~     pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with~     antiretroviral therapy) participants.~   "
227550|NCT00578981|"~     To develop a decision aid to support the decision to use (or not use) bisphosphonates in~     postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the~     decision aid on start and six month adherence to bisphosphonates.~   "
227414|NCT00580788|"~     This is a dose escalation study to determine the maximum tolerable dose of Parathyroid~     Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators~     plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and~     progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy~     (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally,~     the investigators will assess the direct influence of PTHrp on markers of bone turnover, and~     plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.~   "
227415|NCT00580775|"~     As an ancillary study to the KEEPS study (see ClinicalTrials.gov Identifier: NCT00154180),~     the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on~     autonomic function and repolarization; both measured non-invasively via holter monitoring.~   "
227416|NCT00580762|"~     This study will address a true clinical problem by developing a risk/benefit analysis for~     rapid surgical weight loss in the ESRD population. The risks of surgical intervention, as~     well as, potential nutritional concerns, balanced with that of the potential medical benefits~     associated with significant weight loss.~   "
227417|NCT00580749|"~     We will compare the two types of enteral (intestinal) nutrition in regard to patients with~     severe acute pancreatitis in our institution and also in 8 others in the United States.~   "
227418|NCT00580736|"~     The research hypothesis is that topical application of a mixture of pre-polymers of~     polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin~     light scattering, increasing the amount of light reaching the target for diagnostic as well~     as therapeutic purposes.~   "
227419|NCT00580723|"~     The purpose of this open-label study is to determine the tolerance and efficacy of~     twice-daily application of PRK 124 (Pyratine-6)(0.125%) moisturizing lotion for improving the~     signs and symptoms of mild to moderate facial rosacea.~   "
227420|NCT00580710|"~     This study is designed to investigate the effects of diabetes mellitus and its treatment upon~     the body's responses to low blood glucose (blood sugar) levels. Diabetes is a medical~     condition in which blood glucose can rise very high. Treatment of diabetes mellitus involves~     giving insulin (a hormone), which can occasionally cause blood glucose to fall too low. The~     body responds to low glucose levels by producing a number of hormones, which act against the~     insulin to help correct the low blood glucose. These hormones also provide symptoms which~     warn that the glucose is falling too far. These protective warnings by the body may be~     different in people with diabetes. We want to test whether this also means that diabetes~     changes the sensitivity of brain function to a lowering of blood glucose levels. In order to~     answer this question, we need to compare the response of people with diabetes with the~     response of people who do not have diabetes.~      The plan of the study is to lower the subject's blood glucose using insulin, while measuring~     what changes occur in brain function using what is called functional magnetic resonance~     imaging (fMRI).~   "
227421|NCT00580697|"~     This study is to determine the prevalence of lower urinary tract symptoms in women undergoing~     surgery for gynecologic malignancy.~   "
227422|NCT00580684|"~     To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal~     carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the~     rate of penicillin-resistant pneumococci in nasopharyngeal carriage.~   "
227423|NCT00580671|"~     Marijuana remains the most prevalent illicit substance used by adolescents and the number of~     adolescents receiving treatment for marijuana abuse more than tripled during the last decade.~     A small number of clinical trials suggest that family-based and individual interventions have~     efficacy for treating adolescent substance abuse. However, even with these interventions most~     adolescents fail to reduce their substance use substantially, thus, there remains much room~     for improvement of treatment services. The overarching goal of this project is to develop and~     test novel behavioral treatments to enhance treatment outcome in this important treatment~     population, and in so doing, learn more about mechanisms of change that have broader~     implications for addiction science. In our initial Stage IB project Behavioral Treatment for~     Adolescent Marijuana Abuse, we created, manualized, and pilot tested a unique~     contingency-management (CM) intervention that combined abstinence-based voucher incentives~     with contingency management training for parents. A small randomized, clinical trial provided~     encouraging results. When added to a commonly used cognitive-behavior therapy, CM improved~     rates of sustained abstinence during treatment. Adolescents receiving this intervention were~     less likely to relapse over the 9-month follow-up period, however this finding was not as~     robust as the observed during treatment effects, most likely due to the small sample size and~     associated low power to detect effects. Despite strong indicators of the efficacy of this CM~     intervention, there remained room for improvement in increasing rates of treatment response~     and reducing rates of relapse. Hypothesized mediators and moderators of change indicated that~     changes in parenting had direct effects on post-treatment marijuana abstinence outcomes, and~     that abstinence early in treatment was a robust predictor of the CM treatment effect. This~     proposal will systematically replicate and extend these findings. A Stage II trial will~     compare three treatment conditions: (1) cognitive behavior therapy (CBT only); (2) CBT plus~     CM; and (3) CBT plus an enhanced CM model targeting increased early abstinence rates,~     parenting skills, and maintenance of effects. Replicating the initial demonstration of the~     positive effects of CM will extend the scientific evidence for use of CM to increase~     treatment efficacy for substance-abusing adolescents. Testing an enhanced CM model will~     determine if modifications that are consistent with the underlying behavioral principles and~     empiricism supporting CM interventions can result in improved outcomes. Last, assessment of~     potential mechanisms of action, particularly parenting, adolescent psychopathology and~     impulsivity, will provide scientific information directly relevant to future development of~     more effective intervention and prevention models of adolescent substance abuse, and will~     inform us about fundamental mechanisms operating in drug-dependence.~   "
227424|NCT00580658|"~     The purpose of this study is to allow patients to undergo deep brain stimulation (DBS)~     surgery for the treatment of dystonia. This is NOT a research study, but rather, a~     requirement by the FDA for humanitarian use of the deep brain stimulator device in the~     treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by~     the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including~     generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in~     patients 7 years or older. Thus, this proposal request authorization by the IRB to allow~     patients at VUMC to access this HUD therapy.~   "
227425|NCT00580645|"~     The purpose of this study is to examine the effect of smoking cessation medications on~     alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.~      Following 7 days of medication pre-treatment to achieve steady state levels, participants~     complete a laboratory session assessing alcohol self-administration behavior.~      Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily~     smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.~   "
227426|NCT00580632|"~     In Spain, there is little data available concerning the evolution and treatment of Psoriatic~     Arthritis by rheumatologists and dermatologists. This study is designed to obtain more data~     about the clinical and therapeutic management of Psoriatic Arthritis in Dermatology and~     Rheumatology Medical centers.~   "
227551|NCT00578968|"~     This study is being done to examine the influence of Tiotropium (good or bad) on heart~     function at rest and during exercise in patients with moderate to severe chronic obstructive~     pulmonary disease (COPD).~   "
227427|NCT00580619|"~     The investigators propose to test the hypothesis that the sympathetic nervous system~     contributes to the cardiovascular and inflammatory abnormalities present in the chronic~     fatigue syndrome (CFS) and, in particular in the subset of patients characterized by postural~     tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise normal young women,~     and are the cause of significant disability. A substantial proportion of patients referred~     for evaluation of POTS met diagnostic criteria for CFS and, conversely, a subset of patients~     referred for treatment for CFS have POTS. The investigators hypothesize that sympathetic~     activation underlies the pathophysiology of patients in whom CFS and POTS overlap (CFS-P).~   "
227428|NCT00580606|"~     The purpose of this study is to evaluate the safety and immune response to daily sublingual~     (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with~     peanut allergies.~   "
227429|NCT00580593|"~     The goal of this trial is to determine the feasibility of conducting a randomized,~     double-blind, placebo-controlled trial of nocturnal noninvasive positive pressure ventilation~     in persons with amyotrophic lateral sclerosis with an forced vital capacity greater than or~     equal to 50 percent.~   "
227430|NCT00580580|"~     To detect coronary artery disease by both coronary and carotid artery imaging and myocardial~     perfusion imaging using a new low mechanical index real time system.~   "
227431|NCT00580567|"~     The purpose of the this study is to compare pathological gamblers versus non-pathological~     gamblers using tests that measure different components of impulsivity. We aim to invite a~     total of 120 individuals to participate in this study.~      Impulsivity has been described as the cognitive inability to delay gratification, a failure~     to inhibit behavioral action or acting without forethought about consequences. Impulsivity~     has also been seen as a personality trait characterized by risk-taking or sensation seeking~     behavior. Pathological gamblers demonstrate aspects of impulsivity; they act without~     thinking, have difficult inhibiting urges to gamble and desire immediate gratification. The~     goal of this project is to clarify which components of impulsivity are associated with~     pathological gambling. Non-treatment seeking, pathological gamblers and controls will be~     recruited from the community and local casinos. Each participant will be administered a~     battery of tests that represent different operational definitions of impulsivity.~   "
227432|NCT00580541|"~     Increased dietary variety has been shown to increase intake in animals, as well as humans, as~     compared to a diet or meal composed of one food. While most studies investigating dietary~     variety have focused on energy-dense foods (i.e., snack foods) and have emphasized the~     negative component that variety has on intake, very little research has been conducted with~     variety to determine if this food characteristic can be used to increase consumption of~     healthy foods (i.e., fruits). We hypothesize that increasing variety of fruits provided in an~     eating bout will lead to increased intake of these foods. Therefore, the aim of this~     investigation is to test the environmental factor of variety on fruit intake in males and~     females aged 18 to 45 years.~   "
227433|NCT00580528|"~     The purpose of this study is to evaluate the effectiveness of a theory-based intervention~     tailored to constructs in the Health Promotion Model and delivered by two distance modes to~     achieve improvement in healthy eating and physical activity for the control of blood pressure~     (BP) among an underserved and vulnerable population of prehypertensive rural women aged 50 to~     69.~   "
227434|NCT00580515|"~     The purpose of this study is to learn how well family therapy works if given while a family~     member is being treated for a serious illness and whether it helps their family to continue~     meeting for a time after their death. The therapy aims to assist the family communication and~     support during both palliative care and bereavement. The investigators also want to learn how~     many family therapy sessions spread out over time are best for helping patients and their~     families.~      Patients are randomly assigned to one of three groups: patients who receive standard~     palliative care, patients and their families who take part in 6 sessions, and patients and~     their families who take part in 10 sessions.~   "
227435|NCT00580502|"~     This study is to evaluate the safety and efficacy of Gastric Banding for patients with body~     mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.~   "
227436|NCT00580489|"~     The study is exempt from informed consent by the MetroHealth Medical Center institutional~     review board (IRB), because two standards of care are used and there is no increased clinical~     risk to the patient due to the study. The researchers randomize either fentanyl or morphine~     to be given to trauma patients and record how their pain scale is treated along with~     observing for adverse events. They are looking to see if the hypothesized benefits of~     fentanyl (which is much more expensive than morphine) actually exist.~   "
227437|NCT00580476|"~     The goal of this study is to learn more about how we measure depression in elderly cancer~     patients (patients aged 70 and older). Depression is one of the most common causes of~     emotional distress in the elderly and continues to be under-recognized. This is a problem~     because depression can have a negative impact on quality of life. The symptoms of depression~     are linked to poor health outcomes and higher costs of health care. In fact, depression is~     one of the top five concerns facing the elderly today.~   "
227438|NCT00580463|"~     The purpose of the study is to collect samples of brain or spine tumors. Memorial~     Sloan-Kettering Cancer Center would then store them for use by researchers who study brain or~     spine cancer and try to find better ways of treating it. We will also collect blood and~     spinal fluid from patients with brain or spine tumors. The blood and spinal fluids are also~     used for research studies of cancer and its treatment.~   "
227439|NCT00580450|"~     The purpose of this trial is to determine safety and efficacy of 16 weeks treatment with~     thymosin alpha 1 given at 1.6 mg dose once daily by subcutaneous injection in adult patients~     with hematological undergone allogenic bone marrow transplantation and CMV positive.~      The efficacy will be explored assessing the ability of thymosin alpha1 to prevent the~     infection complications.~   "
227440|NCT00580437|"~     Examine the clinical utility of the dobutamine stress contrast echoes and angiograms obtained~     routinely in the evaluation of patients prior to kidney or pancreas transplantation.~   "
227552|NCT00578955|"~     The purpose of this study is to determine if AzaSite Plus is effective and safe for the~     treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.~   "
245968|NCT00333866|"~     This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the~     efficacy and safety of pregabalin in patients with fibromyalgia.~   "
227441|NCT00580424|"~     We propose a prospective cohort study to assess the effect of the progesterone only~     contraceptive pill (minipill) on coagulation parameters known to be associated with risk of~     thrombosis (blood clots) in women who are at increased risk for forming blood clots. We plan~     to recruit women with a history of venous thromboembolism (VTE, blood clot in a vein) and~     women with a history of blood tests which demonstrate an increased risk of thrombosis who~     desire contraception.~      Women enrolled in this study will undergo phlebotomy (blood draw) at baseline (prior to~     starting the minipill), one and three months. Stored samples will be used to measure D-dimer,~     C-reactive protein (CRP), antithrombin (AT), factor VIII, free and total protein S,~     fibrinogen, von Willebrand factor (vWF) and normalized activated protein C sensitivity ratio~     (nAPCsr). Both groups will undergo a general physical and GYN exam prior to enrollment. This~     exam and the blood testing will be provided free of charge. Patients will not be prescribed~     the minipill after completion of the study and will be advised to consult with their primary~     care physician or hematologist if they wish to continue this medication.~   "
227442|NCT00580411|"~     This study is an epidemiological and descriptive study of the lifetime relationship of~     insomnia to alcohol problems.~   "
227443|NCT00580398|"~     The primary aim of the proposed study is to develop and assess the feasibility of delivering~     a smoking cessation intervention to patients undergoing lung surgery that begins before~     surgery and continues up to 3 months post-discharge. The secondary aim is to assess smoking~     cessation rates 3 months following surgery.~   "
227444|NCT00580385|"~     The purpose of this study is to investigate tumors in the laboratory to determine how and why~     they respond, or fail to respond to different drug therapies. This study will also~     investigate why high pressure develops within tumors and how this affects how well drugs~     work. We will also take blood samples before and/or after your procedure to measure~     biochemical factors that may help us predict the behavior of osteogenic sarcoma and other~     solid tumors.~   "
227445|NCT00580372|"~     This experimental study evaluates the effects of a series of intensive drug regimens as~     initial treatment for Multiple Myeloma followed by 2 bone marrow transplantations 4─6 months~     apart in support of high─dose Melphalan, followed by Interferon treatment indefinitely.~   "
227446|NCT00580359|"~     This study is an open-label, single-center, and randomized phase II study designed to~     evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor~     performance status patients with recurrent or metastatic gastric cancer. The randomization~     will be stratified by age (70-85 years versus 65 years and < 70 years) and performance~     status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus 2~     and in ³65 years and <70 years, ECOG performance status 2 versus 3.~        -  S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)~        -  Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment~          will be administered every 3 weeks and will be continued in the absence of disease~          progression or unacceptable toxicity.~   "
227447|NCT00580346|"~     People who aspirate after neurologic insults such as stroke often develop fatal pneumonia.~     This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed~     over the chest wall are connected to electrodes placed around the nerve that closes the vocal~     cords. The patient triggers closure by flipping the switch of a coil taped over the skin~     covering the internal stimulator. Vocal cord motion is verified by videotaping through an~     endoscope, and the status of swallowing is documented radiologically by a modified barium~     swallow.~   "
227448|NCT00580333|"~     The purpose of this study is to find out what effect taking cisplatin in combination with~     bevacizumab before surgery and then standard chemotherapy plus bevacizumab after surgery will~     have on participants with Estrogen Receptor (ER) negative, Progesterone Receptor (PR)~     negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer.~     Cisplatin is used to destroy cancer cells in many types of cancers, and has shown to be~     effective and have manageable side effects. Bevacizumab is an antibody, which is a protein~     that attacks a foreign substance in the body. Bevacizumab slows or stops cell growth in~     cancerous tumors by decreasing the blood supply to the tumors.~   "
227449|NCT00580320|"~     Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma.~     Weekly administration of the combination will prove to be feasible and tolerable at an~     appropriate dose.~   "
227450|NCT00580307|"~     Objective: To determine the efficacy of surgical correction of intranasal mucosal contact~     points in improving quality of life and decreasing medication use in patients with rhinogenic~     headaches.~   "
227451|NCT00580294|"~     The purpose of this study is to see if changing from one pain medication like morphine or~     oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This~     study will examine if the switching from one pain medication to another can be done over a 24~     hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of~     severe pain.~   "
227452|NCT00580281|"~     The drug that you are taking for your cancer, imatinib (GleevecTM), has recently been shown~     to have some new types of side effects. In some people, imatinib can affect how bones are~     made.~      The purpose of this study is to find out if imatinib is causing these side effects in you. We~     can check how your bones form by testing your blood and urine. We can also check your bone~     strength by doing a special X-ray of your bone called bone density (or DEXA scan).~   "
227453|NCT00580268|"~     The purpose of this study is to examine risk factors for relapse of bipolar disorder during~     pregnancy and the postpartum period. The main goal of this study is to find the risks that~     may make it more likely for a woman with bipolar disorder to experience a depressive, manic,~     or hypomanic episode during her pregnancy and the postpartum period.~   "
227454|NCT00580255|"~     It is hypothesized that elevated BNP level correlate with an elevated thoracic~     impedance/fluid index as measured separately by CRT-D devices and external impedance~     cardiography. Ultimately, it is also hypothesized that both BNP and thoracic impedance/fluid~     index measurements are predictive of atrial and ventricular arrhythmias.~   "
227455|NCT00580242|"~     This study proposes using bortezomib in cohorts of 3-6 patients at the doses of 0.7, 1, and~     1.3 mg/m2 on days 1, 4, 8, and 11 to determine the MTD in combination with lenalidomide 10 mg~     a day, for 21 days of a 28 day treatment cycle for patients with myelodysplastic syndrome.~   "
227456|NCT00580229|"~     This study will be an open-label prospective analysis of oral prednisone (compared to IV~     methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis.~     The study will be useful as pilot data to establish that there are no different trends~     between the two treatment strategies at decreasing the frequency and severity of acute~     infusion reactions. It would also establish proof of principle that pre-treatment with oral~     prednisone is equally as efficacious as IV methylprednisolone.~      The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in~     RA.~      By showing that there are no differences in the frequency or severity of acute infusion~     reactions after rituximab when using pre-treatment with oral prednisone compared to I.V.~     methylprednisolone, we will establish proof of principle that oral prednisone is a viable~     alternative to I.V. methylprednisolone. Pre-treatment with oral prednisone would be a~     practical advantage for both the patient and the treating physician. The patient could~     self-administer this treatment at home thereby decreasing the time they would need to spend~     at the infusion center. Further, this dose of prednisone has fewer side effects than 100mg of~     methylprednisolone.~   "
227457|NCT00580216|"~     The objective is to evaluate whether once weekly subcutaneous (SC) injection of~     idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots~     in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose~     warfarin in patients with atrial fibrillation (AF).~   "
227458|NCT00580203|"~     This is a protocol to collect tissues, blood, and other specimens from patients with~     malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in~     laboratory studies to investigate the growth, development, and transformation of normal and~     abnormal cells in the future.~   "
227459|NCT00580190|"~     PF-00572778, a CRH antagonist, is expected to attenuate adrenocorticotropin (ACTH) and~     cortisol responses to naloxone by blocking the effect of the CRH increases induced by~     naloxone at the postsynaptic receptors. Demonstration of a statistically significant~     attenuation of naloxone induced increases in cortisol and/or ACTH concentrations by~     PF-00572778 compared to placebo would thus constitute proof of mechanism for the compound.~     Therefore, this study is to evaluate pharmacodynamic effects of PF-00572778 following~     naloxone challenge in healthy subjects.~   "
227460|NCT00580177|"~     Three different techniques for the surgical repair of groin hernias are compared. Focus has~     been set on operation times, time to full return of functional abilities like walking in~     stairs etc, and if any technique has more complications than the others. Three years results~     are presented in the study.~   "
227461|NCT00580164|"~     This study is attempting to understand whether or not splinting after a fingertip injury~     improves recovery.~   "
227462|NCT00580151|"~     Some of the children who suffer acute burn injury do not have adequate pain and anxiety~     management with the current regimen of scheduled opiates (morphine) and benzodiazepines~     (lorazepam). Other children have significant side effects or contraindications, such as~     constipation or over sedation, when taking these medications. Clonidine is known to reduce~     the need for morphine in the management of postoperative pain. The addition of clonidine to~     the pharmacological treatment of burn wound pain offers a possible adjunct to the standard~     opiate and benzodiazepines regimen. Clonidine has been used in children in both on a~     short-term basis (such as postoperative pain management) and on a long-term basis (such as~     the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the~     hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to~     the management of pain and anxiety in the acutely burned child. All children will be treated~     by protocol with morphine (0.03mg/kilo) q4hr prn pain and lorazepam (0.03 mg/kilo) q 4 hours~     prn anxiety. In addition, after informed consent is obtained the children will be randomized~     to the addition clonidine or placebo. Pain and anxiety will be assessed using standard~     instruments blind to the medication being used on a daily basis Also the total dose of~     morphine and lorazepam during the 10 days of added clonidine or placebo will be recorded..~     The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose will be~     compared between the placebo and clonidine groups with a Student's t test. Once the blind is~     broken the child will be allowed to remain on the clonidine if it is beneficial. The second~     year of the grant will expand the age groups down to younger children and also begin to gain~     information about the effect of clonidine on the hypermetabolic state secondary to burn~     injury.~   "
227463|NCT00580138|"~     The purpose of this study is to determine whether real-time internet evaluations of~     swallowing, or x-ray swallow studies viewed over closed internet circuit, are a reliable~     method of evaluating swallowing function.~   "
227464|NCT00580125|"~     The objective of this study is demonstrate efficacy and a dose-response in the treatment of~     acute exacerbation of schizophrenia in comparison to placebo.~   "
227465|NCT00580112|"~     The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3~     subpopulations of participants with previously treated progressive metastatic ( spread of a~     cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal~     tissue that grows and spreads in the body until it kills) participants.~   "
227466|NCT00580099|"~     Briefly our study is looking at the effects of 4 weeks of assisted exercise on the body~     composition and neurological/behavioral development of healthy growing premature infants~     enrolled between the ages of 30-33 weeks. It is a blinded study where the active group gets~     the exercise intervention and the control group is cuddled for the same amount of time~     -approximately 20 minutes. We get baseline data using muscle ultrasound, bone speed of sound~     and DEXA. We also get baseline blood samples to look at inflammatory mediators and growth~     hormone. Video of each subject is recorded an hour at two time points during the study to~     assess the babies for spontaneous activity. Nutritional intake information is collected daily~     and in the 4th week of the study assessments made for total energy expenditure using doubly~     labeled water. At this point in the study we repeat the ultrasounds and DEXA for comparison.~     Finally in the period just before discharge we do a complex neurological exam using the~     Brazelton NBAS assessment.~   "
227467|NCT00580086|"~     This study is being done to evaluate if MR spectroscopy will give us more information about~     whether or not your chemotherapy will work for you. Spectroscopy is a special set of pictures~     taken with Magnetic Resonance Imaging (MRI) that gives us information about the chemical~     composition of your breast cancer.~   "
227468|NCT00580073|"~     This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab,~     which are all medicines approved by the Food and Drug Administration (FDA) and are~     commercially available. This treatment regimen will possibly be combined with radiation~     before and/or after surgery depending on your response to the treatment. Their use in this~     exact combination is considered experimental. The purpose of this study is to find out how~     effective this combination of chemotherapy is as treatment for rectal cancer that has not~     spread to other parts of the body. The side effects and survival experienced by subjects~     receiving these drugs will also be evaluated. This is a phase II research study.~   "
227469|NCT00580060|"~     This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide~     vaccination in patients with metastatic melanoma. The objective of this study is to determine~     the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a~     multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC~     stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA~     is safe and generates an immune response to peptides derived from antigens on melanoma cells.~   "
227470|NCT00580047|"~     The study is designed to look at the effect of different bone treatment plans on bone loss~     after kidney or kidney/pancreas transplant.~   "
227471|NCT00580034|"~     Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though~     the potential toxicities of the procedure remain high. We and others have shown that a less~     toxic preparative regimen allows reliable allogeneic engraftment for allogeneic~     transplantation.~      The primary purpose of this treatment trial is to follow patients undergoing allogeneic~     transplantation for long term outcomes. The regimen used has been tested in our prior phase I~     / II trial which has completed accrual. The issues of engraftment and rate of graft versus~     host disease have been answered and our success has led to this regimen being a standard~     approach for less toxic allogeneic therapy.~   "
227472|NCT00580021|"~     Compare the clinical characteristics and post-surgical outcomes (overall survival)of~     pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in~     BRCA1 or BRCA2 .~      Compare the clinical characteristics and outcomes (time to progression) of breast cancer~     patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2~     receiving paclitaxel chemotherapy for metastatic disease.~   "
227473|NCT00580008|"~     The purpose of clinical research is to look at the nature of disease and try to develop~     improved methods to diagnose and treat disease.The goal of this study is to evaluate the use~     of computed tomography (CT) scan of the heart in the diagnosis of disease in vein grafts~     after bypass surgery.~   "
227474|NCT00579995|"~     The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous~     sodium bicarbonate for the prevention of CIN after cardiac catheterization.~   "
227475|NCT00579982|"~     To determine the convenience and satisfaction of new orally disintegrating tablet formulation~     (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study~     in participants with a mood disorder, who reported difficulty or discomfort in swallowing the~     currently marketed IR compressed tablet formulation of lamotrigine and who had a person (such~     as a spouse, partner, companion, aid, nurse, caregiver, etc) willing to complete a~     Companion/Caregiver Question. Subjects were switched from the currently marketed lamotrigine~     IR formulation to a matching dose of lamotrigine IR orally disintegrating tablet (ODT) for 3~     weeks to determine convenience and satisfaction.~   "
227476|NCT00579969|"~     The primary purpose of this study is to show, through a controlled masked clinical study of~     subjects with ocular hypertension (OHT), that latanoprost increases the low uveoscleral~     drainage of aqueous humor back to normal levels, and timolol maleate reduces the formation of~     aqueous humor below normal. Both of these mechanisms will effectively reduce intraocular~     pressure (IOP).~      The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the~     fluorophotometric outflow facility, and episcleral venous pressure and on all parameters over~     time.~   "
227477|NCT00579956|"~     Melioidosis, an infection caused by the bacterium Burkholderia pseudomallei, is a major cause~     of community-acquired septicaemia in northeast Thailand. Common manifestations include~     cavitating pneumonia, hepatic and splenic abscesses, and soft tissue and joint infections.~     Despite improvements in diagnostic procedures and treatment, the mortality of severe~     melioidosis remains unacceptably high - approximately 35% with currently used antibiotics~     (ceftazidime or co-amoxiclav). There is clear evidence that antibiotics can affect mortality;~     the use of ceftazidime rather than previous regimens (doxycycline + chloramphenicol +~     co-trimoxazole) led to a 50% reduction in mortality from 80% to 35%. However, the mortality~     in the first 48 hours has not been altered by any treatment regimen. A key question is~     whether alternative antibiotics could improve early outcome. The hypothesis tested is that~     meropenem is superior to ceftazidime in terms of mortality for the treatment of melioidosis.~   "
227478|NCT00579943|"~     Advances in newborn intensive care have lead to dramatic improvements in survival for the~     most premature infants—often weighing 1 pound at birth. Unfortunately, cerebral palsy, mental~     retardation, and developmental delay affect more than 10,000 of these premature infants in~     the U.S. annually. In his studies, Dr. Jeffrey R. Kaiser is trying to understand why these~     premature infants are at such high risk of brain injury, and to learn ways to prevent injury.~     Experts believe that disturbances of brain blood flow regulation are important in causing~     these injuries. Using a novel continuous monitoring system, Dr. Kaiser is able to determine~     an infant's capacity for normal brain blood flow regulation. Contrary to previous thinking,~     he has shown that many of these babies in fact due have normal regulation of their brain~     blood flow. He has observed that brain blood flow may be disturbed during suctioning of the~     breathing tube. Further, he has also shown that infants with high carbon dioxide, those not~     breathing well, have impaired regulation of their brain blood flow. Thus, even stable infants~     are prone to disturbed brain regulation during routine intensive care, which may lead to~     bleeding in the brain and long-term neurologic problems. Dr. Kaiser will study up to 200~     infants to determine 1) the developmental pattern of normal regulation of cerebral blood~     flow; 2) in those with impaired regulation, determine when it develops during the first week~     of life; and 3) determine the relationship between impaired brain blood flow regulation and~     brain injury. Results from this study will help us recognize when premature infants are most~     vulnerable to developing brain injury, allowing prevention and intervention strategies to be~     initiated in a timely fashion.~   "
227479|NCT00579930|"~     To establish a serial ascertainement of specimens from patients with bone sarcomas to be used~     in ongoing cytogenetic and molecular genetic analyses. These data will be integrated and~     correlated with the established Orthopaedic Service clinical database.~   "
227661|NCT00577460|"~     The general aim of this study is to obtain long-term safety and tolerability data on~     pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in~     patients who have previously completed a pramipexole double-blind study in advanced~     Parkinson's disease (PD) (248.525 trial).~   "
227480|NCT00579917|"~     The purpose of this study is to understand how to help survivors of bone marrow transplant~     and stem cell transplant (BMT/SCT) with emotional distress. BMT/SCT has become a more common~     type of treatment for cancer or hematological disorder (blood disease). For this reason,~     there is concern that adjustment after treatment may be difficult for many persons. We have~     found that about 25% of BMT/SCT survivors still feel anxious and distressed about their~     illness and its treatment after at least one year following transplant. This study is one of~     the first to study the impact of counseling on BMT/SCT survivors. The study is being carried~     out at Memorial Sloan-Kettering Cancer Center, Mount Sinai Medical Center, and Hackensack~     University Medical Center.~   "
227481|NCT00579904|"~     The purpose of this study is to learn more about the effects of walnuts, walnut-oil, almonds~     and fish oils on blood sugar and insulin levels in polycystic ovary syndrome (PCOS) patients.~     The hypothesis is that a diet rich in these foods will improve insulin resistance in women~     with PCOS.~   "
227482|NCT00579891|"~     To establish a serum and tissue bank with specimens form patients with colorectal cancer, for~     subsequent immunological and biochemical analysis.~   "
227483|NCT00579878|"~     The study has been designed as a 48-week, double-blind, randomized, controlled study~     comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and~     methotrexate-sulfasalazine-HCQ.~   "
227484|NCT00579865|"~     You may have symptoms like itching, abdominal pain, loss of appetite, fatigue, fevers and~     chills. The treatment you will receive to relieve the blockage is also intended to relieve~     symptoms and improve your quality of life. The purpose of this study is to find out if~     relieving the blockage in your bile duct improves your quality of life.~   "
227485|NCT00579852|"~     The purpose of this study is to compare the results of two CT scans of the chest performed~     within minutes of each other. We will compare several different measurements of lung cancer~     tumors. This study will help show whether we can get accurate results when we compare~     measurements on different CT scans. This information is important for patients with cancer,~     who often have more than one CT scan during their treatment.~   "
227486|NCT00579839|"~     To determine the short and long term effects of placental transfusion at birth by milking and~     delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34~     weeks 0 days weeks' gestation.~   "
227487|NCT00579826|"~     This is a multi-institution double-blind placebo-controlled trial whose main objective is to~     determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by~     Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have~     random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or~     borderline atypia, and a minimum Ki-67 of >1.5%.~      The primary hypothesis is that proliferation and expression of other estrogen response genes~     will be favorably modulated by six months of letrozole relative to placebo without~     substantially increasing hot flashes or worsening overall quality of life.~   "
227488|NCT00579813|"~     The purpose of this study is to better understand the link between obesity and diabetes or~     pre-diabetes.~   "
227489|NCT00579800|"~     The purpose of this study is to evaluate new computer software on breast magnetic resonance~     imaging (MRI). The information from this study may help doctors and scientists develop better~     ways to find breast cancer, and may help future patents with cancer.~   "
227490|NCT00579787|"~     The purpose of this study is to will help us understand how two treatments impact women with~     early stage cervical cancer: a radical hysterectomy, which removes the entire uterus, the~     ovaries, and fallopian tubes versus a radical trachelectomy which removes the cervix, which~     is the bottom part of the uterus. The second leaves the rest of the uterus, the ovaries, and~     fallopian tubes. This means that there is a chance that the woman might be able to get~     pregnant in the future with this type of treatment. We believe that these two operations need~     further study to see how they impact women. This study will look at emotions and issues of~     fertility. The study will also ask about quality of life and sexual functioning. What we~     learn from this study will help us give better information to women considering these~     treatments.~   "
227491|NCT00579774|"~     Advanced glycation products or AGEs are a heterogeneous group of molecules formed by exposure~     of tissue constituents to high levels of reducing sugars, e.g. glucose. The interaction of~     these compounds with extra- and intra-cellular components may account in part for several~     conditions related to aging. It has recently been recognized that AGEs are also formed during~     the preparation of food by heating, are absorbed into the circulation and become largely~     incorporated into tissue components. Accumulation of these exogenous substances over time~     may, together with those generated endogenously, contribute to the clinical manifestations~     and complications of aging.~      This is an interventional-randomized study in which we are trying to determine whether a diet~     low in AGE can effectively reduce circulating AGE levels, with or without altering oxidation~     or inflammatory markers, in a subset of both young and older subjects , over a period of 4~     months. If positive results are obtained, longer-term prospective studies will be designed to~     determine if this intervention can affect disease outcomes in older age subjects.~      The study design is very simple and consists initially of obtaining a dietary history, a~     blood sample, 24-hour urine collection and, subsequently, of determining the effects of a~     low-AGE diet for 4 months on the plasma levels of these compounds in a group of healthy~     subjects.~   "
227492|NCT00579761|"~     This is an analysis of the outcomes of patients having undergone surgical intervention for~     infective endocarditis.~   "
227493|NCT00579748|"~     Optical coherence tomography (OCT) is a non-invasive imaging technique that uses light to~     create pictures of living tissues and has been successfully used to generate high resolution~     cross-sectional images of tissue in the human eye and skin. OCT systems are now commercially~     available for eye and skin use, and several clinical reports on the use of OCT in the~     gastrointestinal tract have been published as well.~      The purpose of this study is to develop a high-speed noninvasive OCT probe which can be~     placed through an endoscope for the early diagnosis of pre-cancerous and cancerous lesions in~     the gastrointestinal tract. This is a pilot clinical research study that is designed to~     advance OCT technology, which may in the future be able to replace or augment endoscopic~     biopsies.~   "
227662|NCT00577447|"~     The purpose of this study is to test the hypothesis that dietary supplementation with the~     omega-3 fatty acid docosahexaenoic acid (DHA) improves the behavior of children with autism.~   "
227494|NCT00579735|"~     Patients who received breast MRI will be evaluated for a variety of indications including : #~     each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion~     clinical finding, 4)questionable mammo finding, 5)silicone leak The number of incidental~     lesions not detected by any other method that were subsequently subjected to biopsy with the~     following BIRADS categories 3−# reasons for bx 4−# 5−# Of the lesions detected % of each~     BIRADS category were postive histologies−ductal, lobular, DCIS, etc. and negative (fibrosis,~     hyperplasia, etc.) Criteria for classification: morphology, dynamics, clinical significance~     will be evaluated and a predictive value established.~   "
227495|NCT00579709|"~     The research purpose is to determine if thymus transplantation with immunosuppression is a~     safe and effective treatment for complete DiGeorge anomaly. The research includes studies to~     evaluate whether thymus transplantation results in complete DiGeorge anomaly subjects~     developing a normal immune system.~   "
227496|NCT00579696|"~     To determine whether community based participatory action research leads to more effective~     cancer prevention and control in underserved communities compared to traditional, topdown~     programs.~   "
227497|NCT00579683|"~     The purpose of this study is to try to learn more about how small molecule kinase inhibitors~     work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and~     similar drugs are more likely to work if a particular DNA change (also known as a mutation)~     is found in a protein that is important in lung cancer. This protein is called the epidermal~     growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working,~     we would like to examine your tumor to learn why these medicines are not working as well.~     Your tumor will be examined for a variety of things including changes in the DNA of the EGFR.~     We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins~     thought to be important in lung cancer.~   "
227498|NCT00579670|"~     To determine whether ziprasidone provides good efficacy and tolerability in the treatment of~     schizophrenic Greek patients.~   "
227499|NCT00579657|"~     Randomized controlled single-blinded intervention study in 111 overweight and obese subjects~     with risk factors of developing type 2 diabetes, with the aim to investigate effects of~     isoenergetic high cereal fiber as compared with high protein diets over 6 and 18 weeks.~      Proof of principle study with analysis according to study protocol, investigating whether~     isoenergetic high cereal fiber and high protein diets with comparable fat contents, if~     adhered to and after exclusion of known confounders such as changes in body weight, intake of~     drugs with known effects on insulin sensitivity, or relevant changes in physical activity,~     indeed affect insulin sensitivity.~   "
227500|NCT00579644|"~     The purpose of this study is to determine if a combination of methotrexate and minocycline~     works better than methotrexate alone in early Rheumatoid Arthritis~   "
227501|NCT00579631|"~     The purpose of this study is to examine the health behaviors of young adults who have been~     treated for cancer, leukemia, or similar illnesses. We will also ask you some questions about~     your family members' and friends' health behaviors. We plan to use the findings from this~     study to design new programs to help teenage cancer survivors resist doing things that might~     harm their health.~   "
227502|NCT00579618|"~     The purpose of this study is to help us learn more about the roles of genes in cancers. Genes~     are short pieces of DNA which determine the inherited characteristics that distinguish one~     individual from another. This study will look at how some genes might raise or lower the~     chance some people may develop cancer. The sample collection will help generate the materials~     needed for this study.~   "
227503|NCT00579605|"~     1. Evaluate the cultural appropriateness of an intervention protocol related to: a)~          motivational interviewing technique; b) stool, urine, and breast milk sample collection;~          and c) infant breastfeeding test weight procedure.~        2. Compare Motivational Interviewing with an attention intervention (infant safety) on: a)~          breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of~          breastfeeding.~        3. Examine urine samples of infants for the presence of the inflammatory cytokine (LTE4)~          and evaluate fecal and breast milk samples of infants for human milk oligosaccharide~          levels.~   "
227504|NCT00579592|"~     The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will~     obviate the need for long-term calcineurin inhibitors in renal transplantation. Most~     successful strategies to date have relied on the use of either tacrolimus or cyclosporine for~     an indefinite period of time. However, the advantage of a long term, calcineurin inhibitor~     free regimen may include improved renal allograft function, a lower incidence of~     hypertension, diabetes, and less drug related side effects. This is a non-randomized~     open-label pilot trial in 30 adult renal transplant patients. Subjects will receive 2 doses~     of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on~     Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric~     coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®)~     therapy for approximately 2 weeks (10-20 days).~   "
227505|NCT00579579|"~     The purpose of this study is to find out what happens to patients after they have surgery for~     rectal cancer. After being treated for rectal cancer, patients tell us that their bowel,~     bladder and sexual function have changed. We are trying to understand how these changes~     affect your quality of life. The research that we have now does not explain these changes or~     problems very well. The patients will be asked questions about bowel function, bladder~     function, sexual function, and quality of life so we can understand these changes better.~     This will help us take better care of our patients in the future, before and after their~     treatment for rectal cancer.~   "
227506|NCT00579566|"~     The purpose of this study is to study normal and sarcoma cells. To study these cells we need~     to have human tissue. You will be having or have already had a procedure to remove tissue. We~     would like to use some of this tissue. We will use it for laboratory studies on the~     diagnosis,behavior and treatment of sarcoma. We will perform an extensive analysis of your~     samples. We will only use extra tissue left over after all needed testing has been done or~     remove an additional small amount of tissue if you are having a biopsy. We will also take~     blood samples before and/or after your procedure to measure biochemical factors that may help~     us predict the behavior of sarcoma.~   "
227663|NCT00577434|"~     This medication is used for procedural sedation and sedation for diagnostic imaging. The~     purpose of this study is to find out what happens to pentobarbital in the body after it is~     given to children who have had heart surgery.~   "
227507|NCT00579553|"~     This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha~     hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton~     pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and~     neonatal outcomes.~      Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal~     progesterone administered intramuscularly versus vaginally in women with singleton pregnancy~     and a history of prior preterm birth.~   "
227508|NCT00579540|"~     Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for~     Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and~     biological actions. It is not yet known which of these oils has the most beneficial effects~     in PCOS patients because they have never been compared to each other head to head. In this~     study the researchers hope to learn more about the effects of these oils on blood sugar and~     insulin levels.~   "
227509|NCT00579527|"~     The study purpose is to determine if thymus transplantation with immunosuppression is a safe~     and effective treatment for atypical complete DiGeorge anomaly. This study will also evaluate~     whether thymus and parathyroid transplantation with immunosuppression is a safe and effective~     treatment for atypical complete DiGeorge anomaly and hypoparathyroidism.~   "
227510|NCT00579514|"~     The basic premise of this research proposal is to determine whether there is any significant~     association between germline polymorphisms and cancers of colon, bladder, breast, testicular,~     prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. This is an exploratory~     study designed to generate hypotheses for further research.~   "
227511|NCT00579501|"~     The purpose of this study is to evaluate the safety and efficacy of trabectedin for the~     treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor~     derived from primitive or embryonal lipoblastic cells).~   "
227512|NCT00579488|"~     The goal of this study is to help us learn more about the roles of genes and cancers that run~     in families. Sometimes, we are born with genes that are changed or altered. Gene changes are~     called mutations. Mutations may be passed down from parent to child. Some mutations cause a~     high risk for cancer. There are two major genes for breast and ovarian cancer. These genes~     are called BRCA --for breast cancer. If you have a mutation in these genes special actions~     may be needed. For a person with a known mutation, we will suggest ways to screen for cancer~     or prevent it. Not everything is known about cancer genes and mutations. The cancer screening~     we suggest may not always be effective. The aim of this study is to explore these questions.~     If you agree we will stay in touch with you to follow your medical history. We will also ask~     you about your family.~      This will allow us to measure the cancer risks of known mutations. The study will also look~     for other cancer genes we do not know about. Whether or not you take part in this study, you~     may have gene testing. If you take part in this study and wish to know, we will tell your~     BRCA gene test results.~      The investigators may perform genetic testing on the blood or saliva sample in one of two~     ways: analysis for mutations in the BRCA1 and BRCA2 genes alone or as part of a panel of~     genes associated with breast cancer predisposition. New technologies are being employed for~     identification of patients with a susceptibility for developing breast cancer and thus~     analysis of multiple genes at one time may be offered to you. If this multi-gene testing~     applies to the patient, a question and answer sheet about this testing will be provided to~     them by their genetic counselor.~   "
227513|NCT00579475|"~     Uterine fibroids are a benign but common condition among women in reproductive age. It is one~     of the most common reasons for hysterectomy since it often causes bleeding problems sometimes~     leading to anemia. Several alternative treatment regimens have been investigated that could~     replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that~     have been tested. In addition to the inhibiting effect on the growth of uterine fibroids~     antiprogestins have been proposed to have an antiproliferative effect on breast tissue.~      The purpose of the present study is to evaluate the effect of mifepristone on the volume of~     uterine fibroids. The study will also address the effect of mifepristone on the breast tissue~   "
227514|NCT00579462|"~     The purpose of this study is to study whether the presence of lung cancer in your body can be~     detected by testing the blood, and if the results of these blood tests change as your tumor~     shrinks or grows.~   "
227515|NCT00579449|"~     The purpose of this research is to evaluate the Healthy Families Durham (HFD) program by~     comparing the traditional 3-year program to 18-months of Healthy Families Durham to Yearly~     Visits with case management referrals to community services as usual, and to determine~     whether participation in the program reduces the number of reports for child maltreatment~     within the first seven years of the child's life.~   "
227516|NCT00579436|"~     The purpose of this study is to determine whether improvement in fat and muscle metabolism~     after the treatment with Omacor (fish oils) provides insight into the link between obesity,~     fat and muscle function leading to metabolic syndrome, which is a risk factor for heart~     disease and diabetes.~   "
227517|NCT00579423|"~     This is a pilot trial designed to assess safety and immunogenicity of a multivalent conjugate~     vaccine for use in patients with biochemically relapsed prostate cancer.~   "
227518|NCT00579410|"~     The purpose of this research is to study the level of acid exposure above the~     gastroesophageal junction and the distal esophagus in patients with reflux symptoms using a~     capsule type acid measurement system. Patients with reflux symptoms are likely to have more~     acid reflux just above the junction of the stomach and the esophagus that may help to improve~     the diagnosis of gastroesophageal reflux disease (GERD). This may help better treat the~     reflux symptoms.~   "
227519|NCT00579397|"~     Objectives:~        1. To show feasibility and reproducibility of performing a multiplex ligation-dependent~          amplification procedure (RT-MLPA)~        2. To describe the profile of changes in inflammatory gene products, using RT-MLPA, in~          pediatric patients receiving stem cell transplant~        3. To determine if changes in a specific inflammatory product, or a combination of~          inflammatory products, can predict grade 2-4 acute graft-versus-host disease~   "
227520|NCT00579384|"~     The purpose of this study is to check the Effects of JNJ-26489112 on the Photic Induced~     Paroxysmal electroencephalogram (EEG) Response in Patients with Photosensitive Epilepsy.~   "
227739|NCT00576394|"~     entGlycemic control has been found to improve clinical outcomes following Coronary Bypass~     Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl)~     as opposed to more moderate control (120-180mg/dl) will further improve outcomes.~   "
227521|NCT00579371|"~     We hypothesize that the following improvements to islet transplantation will increase the~     islet mass successfully isolated and allow for engraftment from a single pancreas. The~     improvements are:~        -  Using Two-Layer method preservation to improve pancreas quality before islet isolation~        -  Maintaining isolated islets in culture before transplantation~        -  Using a steroid-free immunosuppression regimen~        -  Transplanting the best combination of donor and recipient possible after HLA screening~          and final crossmatching~   "
227522|NCT00579358|"~     Congenital heart disease is one of the most common malformations in newborns. About 1% of~     newborns have cardiac malformations. Many need open heart surgery, which contributes~     substantially to pediatric mortality and morbidity. Recent advances in genetics suggest that~     many congenital heart defects are caused by mutation of genes. So far, half a dozen genes are~     found to be associated with congenital heart diseases, such as TBX5, NKX2.5, and GATA4, to~     name a few. In the near future, more genes will be identified.~      This study will evaluate the role of mutation of genes in congenital heart diseases and study~     the genotype-phenotype correlation. The central hypothesis is that a significant percentage~     of congenital heart disease is caused by mutation of genes involved in heart development, and~     the phenotype with missensed mutations is milder than nonsense mutation. Another hypothesis~     is that a significant proportion of patients with cardiac malformations will have mutations~     in their genes. The specific aim is to test the mutations of these genes in patients with~     congenital heart diseases. The study will provide substantial information to understand how~     the human heart develops. In the future, prenatal diagnosis could be developed based on this~     study.~   "
227523|NCT00579345|"~     The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell~     culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine~     (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone and when~     administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects.~     The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination~     with either cTIV or eTIV_a in adults and elderly subjects.~   "
227524|NCT00579332|"~     Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for~     prostate cancer progression.~   "
227525|NCT00579319|"~     When breast MRI is used to determine the extent of local disease, the management changes,~     resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is~     better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of~     disease in women diagnosed with breast cancer. It has not been established how management of~     breast cancer patients has been affected by the use of breast MRI or how that management has~     affected the outcome for these patients. This retrospective chart review will document~     management and outcome for breast cancer patients who have had pre treatment breast MRI.~   "
227526|NCT00579306|"~     The goals of this trial are to determine the prognostic significance of an elevated level of~     inflammatory blood markers in people who have experienced small subcortical strokes and who~     are enrolled in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial.~   "
227527|NCT00579293|"~     This study will compare two ways of having people respond to a questionnaire about health and~     emotional well-being: on a computer and with paper and pencil. We will see how long it takes~     using both methods. We will also ask you how you feel about using a computer to answer the~     questions.~   "
227528|NCT00579280|"~     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of~     quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in~     the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or~     generalized anxiety disorder and current at least moderately severe anxiety.~   "
227529|NCT00579267|"~     The primary aims of this study are to assess:~        1. The inter-rater and test-retest reliability of the MINI-KID~        2. The validity of the standard MINI-KID interview in relation to the parent rated~          pencil/paper version (MINI-KID-P) and th longer clinician rated Schedule for Affective~          Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version~          (K-SADS-PL) and expert opinion (when available).~      Secondary aims will include evaluating the concordance between: The Children's Global~     Assessment Scale (a required part of the K-SADS) with the clinician-rated Sheehan Disability~     Scale (to be administered with the MINI-KID) as a measure of illness severity.~   "
227530|NCT00579254|"~     To assess the effect of single pill therapy on the management of hypertension and other~     cardiovascular risk factors (e.g., dyslipidemia) in Indian patients in whom the treating~     doctor has already considered that the administration of the amlodipine/atorvastatin single~     pill to be appropriate~   "
227531|NCT00579241|"~     To Determine whether transcranial ultrasound can detect the presence of intravenously~     injected microbubbles used routinely for dobutamine stress echocardiography.~   "
227532|NCT00579228|"~     The purpose of this study is to look at the progression of cardiovascular disease (CVD) in~     normal control individuals and in patients with controlled diabetes.~   "
227533|NCT00579215|"~     The purpose of this study is to evaluate a new program to help the patient and the caregiver~     make decisions about treatment for lung cancer. We need to know if a new information program~     is helpful to patients. The way that we will do this is by comparing it with the usual~     information program that we now provide.~      Patient are asked to make difficult decisions about their treatments. These decisions may~     include when to change treatments or when to stop treatment altogether. Most patients ask a~     family member or close friend to help them with these difficult decisions. A caregiver is~     someone they can count on to give support (either emotional or physical) over a period of~     time. The doctors and nurses will also help patients and their caregiver to make these~     decisions.~      They will tell them the risks with each treatment, the success with each treatment, and how~     much time there is for making each decision.~   "
227534|NCT00579202|"~     The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer~     under conditions of routine clinical use for hemodialysis~   "
227535|NCT00579189|"~     The purpose of this study is to determine if a topical otic formulation is safe and effective~     in treating middle ear infections in patients with ear tubes.~   "
227761|NCT00576095|"~     The primary objective of this study is to investigate the relationships among findings in~     structural and functional neuroimaging, cognitive testing and HPA~     (hypothalamic-pituitary-adrenal) axis dysregulation in psychotic depression.~   "
227536|NCT00579163|"~     The purpose of this study is to better understand the genetic causes of cancer and the~     inherited tendency to develop cancer. To accomplish this, blood specimens and/or saliva~     samples and/or tumor and normal tissue blocks from patients and families of patients with~     cancer will be collected. Blood specimens will be frozen and stored for analysis at a later~     date. Tumor tissue and normal tissue will be stored for analysis at a later date. In order to~     perform this study, patients and members of their families will be asked to provide blood~     samples and/or saliva samples. Individuals will be asked to provide a history of cancer in~     their relatives at the time the blood sample is given. No relatives will be contacted before~     they have been asked by a family member if they wish to participate in this study. If they do~     wish to participate, the relatives should indicate this by returning the Family Member~     Consent for Contact Form After we receive this form, arrangements may be made for the family~     member to send in a blood and/or saliva sample or to come in person to provide the sample to~     us.~      Except for family history, no medical information provided by one member of a family will be~     discussed with other family members. At the end of this form, we will also ask for your~     permission to be contacted in the future to discuss information about your health, additional~     research with your samples and/or certain research findings possibly related to your sample.~   "
227537|NCT00579150|"~     This is an observational, prospective cohort study describing pregnancy outcomes in women~     with pre-existing (prior to pregnancy) type 2 diabetes who have been exposed to any~     formulation of exenatide during pregnancy. The pregnancy registry will compare the occurrence~     of the pregnancy outcomes of interest with those collected from a prospective group of women~     with pre-existing type 2 diabetes who have been exposed to one or more antidiabetic~     medications other than exenatide during pregnancy. Insulin exposures are acceptable in both~     groups but must be in addition to one or more other antidiabetic medications in the~     non-exenatide group.~      The primary study objective is to evaluate the percentage of major birth defects (i.e., those~     that caused significant functional or cosmetic impairment, required surgery, or were~     life-limiting) following use of exenatide during pregnancy for treatment of type 2 diabetes~     compared to the percentage of major birth defects following use of one or more antidiabetic~     medications other than exenatide during pregnancy for treatment of type 2 diabetes.~      The secondary objectives of the Exenatide Pregnancy Registry are to evaluate the percentage~     of other adverse pregnancy outcomes (e.g., spontaneous abortion, stillbirth, preterm birth)~     and any potential impact of exenatide use during breastfeeding among pregnancies or births in~     women who used exenatide for pre-existing type 2 diabetes:~      This study is being conducted in the United States (US). Enrollment in the Registry is~     voluntary. The Exenatide Pregnancy Registry is sponsored by AstraZeneca and is managed by INC~     Research, LLC. The scientific conduct and analysis of the Registry is overseen by a Registry~     Review Committee (RRC) consisting of experts in maternal and fetal medicine,~     teratology/genetics, epidemiology, type 2 diabetes in pregnancy and/or pediatrics.~   "
227538|NCT00579137|"~     This study is to discover whether children with severe combined immunodeficiency disease~     (SCID) or other primary immunodeficiency disorder (PID) for which no satisfactory treatment~     other than stem cell transplantation (SCT) exists can be safely and effectively transplanted~     from HLA mismatched (up to one haplotype) related donors or unrelated matched or mismatched~     (up to one antigen) donors, when leukocytolytic monoclonal antibodies (MAb) and Fludarabine~     are the sole conditioning agents. Three monoclonal antibodies will be used in combination.~     Two of them are rat IgG1 (immunoglobulin G1) antibodies directed against two contiguous~     epitopes on the CD45 (common leucocyte) antigen. They have been safely administered as part~     of the conditioning regimen for 12 patients receiving allografts (HLA matched and mismatched)~     at this center. They produce a transient depletion of >90% circulating leucocytes. The third~     MAb is Campath 1H, a humanized rat anti-CD52 MAb. Campath 1H, Alemtuzumab, has been licensed~     to treat B-cell chronic lymphocytic leukemia (B-CLL) and more recently has been safely given~     at this and other centers as part of a sub-ablative conditioning regimen to patients with~     malignant disease. Because these MAb produce both profound immunosuppression and significant,~     though transient, myelodestruction we believe they may be useful as the sole conditioning~     regimen in patients with SCID, in whom the use of conventional chemotherapeutic agents for~     conditioning may produce or aggravate unacceptable and even lethal short term toxicity. We~     anticipate MAb mediated subablative conditioning will permit engraftment in a high percentage~     of these patients with little or no immediate or long term toxicity. Campath IH persists in~     vivo for several days after administration and so will be present over the transplant period~     to deplete donor T cells as partial GvHD prophylaxis. Additional Graft versus Host Disease~     (GvHD) prophylaxis may be provided by administration of FK506.~   "
227539|NCT00579124|"~     This is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (GVHD)~     in patients receiving unrelated or partially matched related donor peripheral stem cells~     using the CliniMACS system to positively deplete T cells to prevent severe GVHD. Feasibility~     will be tested, focusing on engraftment, treatment-related mortality (with a specific focus~     on interstitial pneumonitis) and severe GVHD.~   "
227540|NCT00579111|"~     Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving~     an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are~     created in the bone marrow. They grow into different types of blood cells that the body~     needs, including red blood cells, white blood cells, and platelets. In a transplant, the~     body's stem cells would be killed and then replaced by stem cells from the donor. Usually,~     patients are given very high doses of chemotherapy (drugs which kill cancer cells) prior to~     receiving a stem cell transplant. However, patients that are older, have received several~     prior treatments, or have other organ diseases are at a high risk of getting life-threatening~     treatment-related side effects from high doses of chemotherapy. Over the past several years,~     some doctors have begun to use lower doses of chemotherapy for preparing patients for a stem~     cell transplant.~      A condition that can occur after a stem cell transplant from a donor is Graft Versus Host~     Disease (GVHD). It is a rare but serious disorder that can strike persons whose immune system~     is suppressed and have received either a blood transfusion or a bone marrow transplant.~     Symptoms may include skin rash, intestinal problems similar to inflammation of the bowel and~     liver dysfunction.~      This research study uses a combination of lower-dose chemotherapy agents that is slightly~     different from those that have been used before.~      The medicines that will be used in this study are Fludarabine, Busulfan, both chemotherapy~     medicines, and Campath. Campath is a monoclonal antibody (a type of substance produced in the~     laboratory that binds to cancer cells). It helps the immune system see the cancer cell as~     something that needs to be destroyed.~      This research study will help us learn if using Fludarabine, Busulfan and Campath prior to an~     allogeneic stem cell transplant can provide treatment for blood disorders while decreasing~     the incidence of side effects.~   "
227541|NCT00579098|"~     To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be~     effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial~     ablation procedure. We further hypothesize this reduction will result from diminished~     peri-procedural inflammation, which will be reflected in lower C-Reactive Protein (CRP)~     values in the blood.~   "
227542|NCT00579085|"~     Complex Regional Pain Syndrome is a debilitating and extremely difficult to treat condition.~     There is a large body of evidence demonstrating the therapeutic value of N-methyl-D-aspartate~     (NMDA)-receptor antagonists in CRPS. The NMDA antagonist ketamine has been shown to be~     effective in the treatment of CRPS, resulting in complete remission of the disease in some~     patients. The purpose of this study is to evaluate intravenous outpatient infusion of~     sub-anesthetic doses of ketamine for the treatment of CRPS. A thorough evaluation of this~     procedure, providing information into the degree of relief and which of the constellation of~     RSD symptoms are best alleviated by this procedure would result in the optimization of this~     therapy for the treatment of CRPS.~   "
227543|NCT00579072|"~     The purpose of this study is to find out if therapy with hormones (such as Lupron, Casodex,~     Zolodex or Degarelix) change a person's thinking abilities.~   "
227544|NCT00579059|"~     The purpose of this prospective clinical data collection is to compare the outcomes of two~     different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia.~   "
227553|NCT00578942|"~     Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though~     the potential toxicities of the procedure remain high. We and others have shown that a less~     toxic preparative regimen allows reliable allogeneic engraftment for allogeneic~     transplantation.~      The primary purpose of this treatment trial is to follow subjects undergoing allogeneic~     transplantation for long term outcomes. The regimen used has been tested in our prior phase I~     / II trial which has completed accrual. The issues of engraftment and rate of graft versus~     host disease have been answered and our success has led to this regimen being a standard~     approach for less toxic allogeneic therapy.~   "
227554|NCT00578929|"~     A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal~     spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6~     to 11 years with a history of seasonal allergic rhinitis.~   "
227555|NCT00578916|"~     The purpose of this study is to determine how the human body processes and eliminates the~     drug (BMS-690514.~   "
227556|NCT00578903|"~     Patients have been diagnosed with severe Aplastic Anemia that have not responded to treatment~     with immunosuppressive therapy (drugs that suppress the immune system, for example Steroids).~     The immune system is the system in the body that helps protect the body and fights bacterial,~     viral and fungal infections.~      Research studies have shown that patients with Aplastic Anemia have improved survival (may~     live longer) after receiving a HLA (Human Leukocyte Antigen) identical sibling (brother and~     sister) stem cell transplants. Patients who do not have matched siblings can undergo~     immunosuppressive therapy, which has also shown to improve outcome. Unfortunately patients~     who do not respond to immunosuppressive therapy usually die. The best chance of survival for~     these patients is an HLA matched unrelated or mismatched related stem cell transplant as~     described below.~      Stem cells are created in the bone marrow. They mature into different types of blood cells~     that people need including red blood cells which carry oxygen around the body, white blood~     cells which help fight infections, and platelets which help the blood to clot and prevent~     bleeding. For a matched unrelated stem cell transplant, stem cells are collected from a~     person (donor) who is not related to the patient but who has the same type of stem cells. For~     a mismatched related stem cell transplant, stem cells are collected from a donor who is~     related to the patient and whose stem cells are almost the same as those of the patient but~     not exactly. The patient then receives high dose chemotherapy. This chemotherapy kills the~     stem cells in the patient's bone marrow. Stem cells that have been collected from the donor~     are then given to the patient to replace the stem cells that have been killed.~      The major problems associated with these types of stem cell transplants are graft rejection~     (where the patient's immune system rejects the donor stem cells) and severe graft versus host~     disease (GVHD), where the donors stem cell reacts against the patient's tissues in the body.~   "
227557|NCT00578890|"~     Osteomyelitis is a frequent complication of diabetic foot ulcer. Several therapeutic~     strategies are used : medical treatment with antibiotics and foot offloading or surgical~     treatment consisting in the resection of infected bone and a shorter antibiotic course. The~     medical treatment risk is a longer healing time and a risk of bone infection relapse. The~     surgical treatment risk is the ulcer relapse because of the modification of the foot~     structure. These treatments need to be compared in terms of benefit/risk ratio. Our~     hypothesis is : 1) in the medical treatment group a 7 month mean healing time of and a 15%~     osteomyelitis recurrence rate;2) in the medical-surgical treatment group a 4 month mean~     healing time and a 10% osteomyelitis recurrence rate.~   "
227558|NCT00578877|"~     This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will~     enroll approximately 450 couples at risk for pregnancy at six study sites in the U.S. The~     study will randomly assign approximately 300 couples to use the SILCS diaphragm with~     BufferGel and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9~     gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about~     80 women (40 at each site). The primary objective of this study is to estimate the cumulative~     6-month typical-use pregnancy probability for women using the SILCS diaphragm with a~     contraceptive gel.~   "
227559|NCT00578864|"~     High-risk neuroblastoma is an aggressive childhood cancer that shows up as a lump or mass in~     the belly or around the spinal cord in the chest, neck, or pelvis. Often the tumor has spread~     around the body to the bones or to the soft center of the bone, called the bone marrow.~     High-risk neuroblastoma often responds to treatment at first, but it frequently comes back~     and may be even more difficult to treat.~      Chemotherapy (drug treatments for cancer) is usually given at high doses in short bursts (3~     to 5 days) followed by a few weeks of rest and recovery. This burst and recovery is called a~     cycle and usually takes about 21 days. Some scientists and physicians have tried to give~     chemotherapy at lower doses for more days, called metronomic chemotherapy. This method of~     giving chemotherapy has been used to treat neuroblastoma that has failed more standard types~     of treatment (relapsed neuroblastoma) and has shown some promise for those patients. One of~     the reasons it may work is by killing the blood vessels that feed the tumor as well as~     killing tumor cells themselves (the way that burst chemotherapy works). We think that giving~     a burst of chemotherapy together with metronomic therapy may kill the tumor while decreasing~     the side effects that we have seen in the past.~      Treatment for high risk neuroblastoma usually occurs in 3 stages: induction, consolidation,~     and maintenance. During the induction phase, patients will receive chemotherapy and possibly~     more surgery to get rid of most of the tumor cells. Most of the chemotherapy drugs during~     induction will be given in the standard burst method. One of the chemotherapy drugs,~     etoposide, will be given in lower, metronomic doses. The doctors will study how the tumors~     respond and the side effects patients have. After induction most childrens' tumors will have~     disappeared, also called remission. These children will receive the second stage of treatment~     called consolidation. During this stage, subjects will receive radiation treatments to the~     tumor and then higher doses of chemotherapy. Because of the side effects of the high doses of~     chemotherapy, we will collect and store some special blood cells (called hematopoietic stem~     cells) early in treatment and keep them frozen. After the high doses of chemotherapy, these~     cells will be thawed and given to the subject. . This is called hematopoietic stem cell~     transplant (HSCT). The final stage of treatment, called maintenance, consists of a drug taken~     by mouth for 6 months.~      Surgery to remove large, or bulky, tumors is a standard part of treatment for high risk~     neuroblastoma. A few children can have their main tumor removed before chemotherapy, but most~     require the tumor to shrink first. Surgery has usually been scheduled for after 3 to 5 cycles~     of therapy, but no one really knows how quickly the tumors are ready to come out. Because~     chemotherapy has significant side effects that can change the risks of surgery, we will study~     how early surgeries to remove tumors can happen.~      This study is being done to evaluate the outcomes of disease response and survival in~     children with high risk neuroblastoma treated on this regimen.~   "
227560|NCT00578851|"~     The objective of this study is to gather clinical and survivorship information for the~     C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.~   "
227561|NCT00578838|"~     The purpose of this study is to see whether magnetic resonance (MR) techniques can detect~     changes caused by chemotherapy in the livers of patients who have been treated for colorectal~     cancer. Some patients who undergo chemotherapy for colorectal cancer may experience~     side-effects in their livers. These side effects may influence further treatment options. If~     this study finds that MR techniques detect changes in the liver due to chemotherapy, then MR~     methods may eventually be used to help patients and physicians plan further treatment.~   "
227562|NCT00578825|"~     The study aims to examine whether the combination of Lopinavir/Ritonavir plus Ribavirin for~     treatment of severe acute respiratory syndrome (SARS) is superior to placebo.~   "
227563|NCT00578812|"~     The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved~     investigational device exemption (IDE) clinical trial conducted in the United States to~     evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and~     anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with~     adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a~     degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical~     trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM~     Cervical Disc or ACDF.~   "
227564|NCT00578799|"~     This study is being conducted in patients who have been diagnosed with ulcerative colitis~     (UC), a form of inflammatory bowel disease (IBD) - a disease of the intestine.~      The purpose of this study is to test the therapeutic (medical treatment) effects of daily~     consumption of Kyo-Dophilus (a commercially available dietary supplement often used by~     individuals with inflammatory bowel disease) on their UC. Kyo-Dophilus consists of three~     probiotic bacteria (beneficial bacteria to help maintain the balance of good bacteria in the~     intestine) to help treat inflammatory bowel disease caused by bad bacteria. Patients will~     still be maintained on their clinical standard of care for their UC as part of their~     participation in this study.~   "
227565|NCT00578786|"~     AMB-320/321-E was designed to provide long-term, controlled monitoring of pulmonary arterial~     hypertension (PAH) patients treated with ambrisentan (AMB) in order to properly define the~     adverse event profile associated with this endothelin receptor antagonist (ERA), including~     the incidence and severity of elevated serum liver function tests (LFTs). In addition, this~     study continued the efficacy assessments of the previous studies, examined long-term AMB~     treatment success, and compared long-term survival of subjects treated with AMB to the NIH~     registry of patients with PAH.~   "
227566|NCT00578773|"~     The purpose of this study is to determine if an otic formulation is safe and effective in~     treating peri-operative tube otorrhea.~   "
227567|NCT00578760|"~     Aspirin (ASA) has been shown, in an animal model, to attenuate the ototoxic properties of~     cisplatin. The researchers plan to investigate this in patients undergoing cisplatin~     chemotherapy.~      The researchers hypothesise that low-dose aspirin can prevent cisplatin induced ototoxicity~     in the clinical setting.~   "
227568|NCT00578747|"~     Markings placed on the skin are an accurate representation of the underlying surgical cavity~     and are adequate to use for patient setup for accelerated partial breast irradiation.~   "
227569|NCT00578734|"~     Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated~     in young children with acute respiratory failure who require mechanical ventilation (life~     support), to determine if it is safe and if treatment with lucinactant will reduce the number~     of days a child needs mechanical ventilation (life support).~   "
227570|NCT00578721|"~     The purpose of this research study is to understand the effects of oral aspirin taken daily~     with an arginine-restricted diet on certain colorectal cancer biomarkers in treated~     colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence~     and for development of secondary colorectal cancers in the future. Specific chemicals~     (polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help~     understand a person's risk for developing colorectal cancer. Specific biomarkers associated~     with colorectal cancer have been identified in prior laboratory studies. By measuring these~     predefined biomarkers before and after the study intervention, we can assess how they are~     affected by the intervention, and gain knowledge about their usefulness in colorectal cancer~     patients on clinical trial.~      This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily~     with an arginine-restricted diet designed to reduce arginine intake by at least 30% during~     the 12-week study period. The biomarkers will be obtained from patient by performing~     endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy~     (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are~     done to evaluate changes in tissue content that may relate to early events in colon cancer~     formation. This was the procedure used to diagnose your condition initially. There will be 24~     patients enrolled into this study performed through University of California Irvine Medical~     Center.~   "
227571|NCT00578708|"~     The purpose of this feasibility study is to investigate the safety of the AMPLATZER®~     Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous~     Ventricular Septal Defects.~   "
227572|NCT00578695|"~     The purpose of this study is to determine the safety and efficacy of lixivaptan in the~     treatment of hyponatremia in patients with congestive heart failure.~   "
227573|NCT00578682|"~     To evaluate the safety and tolerability of a single IV dose of MEDI-557.~   "
227574|NCT00578669|"~     The primary purpose of this study is to determine whether, among smokers with elevated~     depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun~     8 weeks prior to and extended throughout standard smoking cessation treatment with~     transdermal nicotine patch (ST-TNP) will result in superior short-and long-term smoking~     cessation outcomes compared to sequential pharmacotherapy with placebo medication combined~     with ST-TNP. The secondary aim of the study is to test the hypothesis that, among smokers~     with elevated depressive symptoms, sequential treatment with fluoxetine will result in lower~     levels of depressive symptoms and negative mood and higher levels of positive mood~     immediately prior to and throughout the course of smoking cessation treatment relative to the~     placebo condition.~   "
227575|NCT00578656|"~     Milk is the among the most common food allergens in infants and children. The majority of~     children outgrow their allergies; however, the exact mechanisms by which food tolerance is~     achieved are unknown. Strict avoidance of the offending food is currently the only known~     therapy. However, subjects have been known to lose food hypersensitivity while frequently~     ingesting small amounts of processed forms of the offending product. The purpose of this~     study is to investigate whether ingestion of small amounts of processed milk protein will be~     permitted without compromising the chances of either outgrowing milk hypersensitivity or~     prolonging the time needed to achieve clinical tolerance.~   "
227593|NCT00578396|"~     This study is designed to investigate the dietary influence of grapes in colon cancer~     prevention. A natural compound found in the skin of grapes, resveratrol, may protect against~     cancer by acting as an antioxidant (a chemical compound or substance that helps reduce~     damages due to oxygen). This compound is known to block colon cancer cell lines from growing~     in the laboratory. The purpose of this study is to determine the minimum amount of~     resveratrol-rich fresh red grapes needed to exhibit such signs of prevention.~   "
227594|NCT00578383|"~     This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some~     of the symptoms of depression in bipolar disorder or major depression.~   "
227664|NCT00577421|"~     A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density~     and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal~     Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080,~     and RVE2001079 (NCT01249261)~   "
227576|NCT00578643|"~     This study is for patients with chronic granulomatous disease (CGD), which is a disorder of~     the immune system that puts them at risk for severe infections. CGD is caused by a genetic~     defect that stops or prevents the white blood cells from killing certain bacteria and fungi.~     This condition cannot presently be cured by standard treatment with drugs or surgery. The~     course over time of CGD may differ in severity among patients, but those children who develop~     severe infection at a young age are most likely to have a more severe clinical course.~     Medicine including antibiotics, antifungals, and interferon gamma, may help some patients~     with CGD; however even with continuous treatment with these medications, most patients with~     CGD will have chronic and recurrent infections. Transfusion of healthy or normal white blood~     cells may help overcome infection, but white cell transfusions lead to allergic reactions and~     fever and the benefit of transfusion lasts only a matter of hours. Ultimately, chronic~     infections can damage or injure the body organs such as the lung, liver, or bone. Injury to~     the lung or liver can lead to lung or liver failure and death. Medicines used to treat~     infection can damage body organs such as the kidney. Infections may become resistant to~     antibiotic or antifungal treatment, and infections not responding to treatment can be deadly.~      It is now known that under specific conditions and with special treatment, blood stem cells~     (the cells that make blood) can be transferred or transplanted from one person to another.~     Stem cell transplantation has been done for patients with CGD who have a healthy brother or~     sister and who share the same immune type (HLA type) as the patient. Stem cell~     transplantation allows healthy or normal white cells from the stem cell donor to grow or~     develop in the patient's bone marrow making the donor's white cells. These healthy white~     cells can fight infection and prevent future infections for a patient with CGD.~      Patients on this study will receive stem cells from a related or an unrelated donor. The~     donor will be closely matched to the patients immune type but the donor is not a brother or~     sister. This type of transplantation has been done only a few times for patients with CGD,~     although this type of transplant is commonly done for other reasons, e.g. leukemia. The~     reason this treatment is investigational is that we do not know the likelihood of benefit~     that the patient will receive. It is possible that they will have great benefit, like some of~     the patients who have been transplanted from a brother or sister. It is possible that the~     side-effects of treatment may be too severe so that the transplant won't work.~      The purpose of this research study is to evaluate whether or not patients with CGD treated~     with a stem cell transplant from a non-matched and/or non-related donor can have a good~     outcome from the procedure with an acceptable number of side-effects.~   "
227577|NCT00578630|"~     The purpose of this study is to develop tests that will allow us to determine who will react~     differently to the drugs used to treat cancer. We also want to see who will react differently~     with preparing for a bone marrow transplant.~   "
227578|NCT00578617|"~     The CABANA pilot study is designed to test the hypothesis that the treatment strategy of~     percutaneous left atrial catheter ablation for the purpose of the elimination of atrial~     fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or~     anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.~   "
227579|NCT00578604|"~     The objective of this project is to further the development of a non-invasive optically based~     NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment~     optimization of chronic wounds (especially diabetic) in a clinical setting. The end goal of~     this project is a portable and compact device that would be simple to operate by minimally~     trained health care personnel. Our animal studies have shown that the early healing of~     chronic wounds can be characterized by absorption and scattering of light at near infrared~     wavelengths ranging from 680 nm to 950 nm. If our project is successful we will be providing~     the clinician the ability to predict if a wound is healing and if a particular treatment is~     successful in accelerating healing before any changes are observed by wound size contraction~     or other visible clinical signs. Our hope is that the fNIR optical device will provide~     conclusive therapeutic treatment information as early as 5 weeks after initial evaluation,~     before it would be obvious on gross examination of the patient.~   "
227580|NCT00578591|"~     This is a prospective, open-label pilot study in which 4 doses of Rituximab are administered~     to patients who have developed SR-aGVHD following allogeneic hematopoietic transplant (AHT).~     The study is designed to determine the overall survival at 180 days after treatment with~     rituximab, and evaluates the safety and clinical response to rituximab in this study~     population. Study entry: Patients must enter study on or before day +100 posttransplant.~   "
227581|NCT00578578|"~     To study the anti-inflammatory effects of marine omega-3 fatty acids, also known as n-3~     polyunsaturated fatty acids (PUFA), we propose a randomized, double-blinded, prospective,~     single-center trial to examine the effect of supplementary n-3 PUFA on serum high sensitivity~     (hs) CRP levels.~      Inclusion Criteria Age > 18 hs CRP >3mg/L and <10 mg/L~      Exclusion Criteria~      Active infection Systemic Inflammatory Disease Autoimmune disorders Systemic Lupus~     Erythematosus (SLE) Rheumatoid Arthritis (RA) Systemic Sclerosis (Scleroderma) Sjögren's~     Syndrome Behçet's Syndrome~      The Vasculitis Syndromes Including:~      Wegener's granulomatosis Temporal arteritis (Giant cell arteritis) Takayasu's arteritis~     Henoch-Schönlein purpura Predominantly cutaneous vasculitis (hypersensitivity vasculitis)~     Sarcoidosis Amyloidosis Currently on warfarin Cr > 2.0 Fish Allergy Pregnancy or~     unwillingness to use some form of birth control in women of child-bearing age during the 8~     weeks.~      We will enroll 200 pts. at Willoughby Hills Family Health Center over a 2 month period 100~     pts. will receive OMEGA-3, 100 pts. will receive placebo Drug is to be taken over 8 weeks Pt.~     will return to Willoughby Hills in 8 weeks for a follow-up hsCRP. A brief questionnaire will~     be completed by the nurse/pt, including vital signs at baseline and follow-up .~      Primary Outcome:~      hsCRP levels after 8 weeks of treatment with PUFA~   "
227582|NCT00578565|"~     This study will examine the course of patients with progressive rheumatoid arthritis~     associated interstitial lung disease (RA-ILD) treated with rituximab for safety and~     progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be~     assessed through patient history, physical exams and laboratory parameters.~        -  Twelve male/or female patient with RA-associated lung disease (6 of each nonspecific~          interstitial pneumonia (NSIP) and usual interstitial pneumonia (UIP) histological~          subtype) will be enrolled~        -  The study involves 12 visits over 48 weeks~        -  Rituximab will be administered intravenously at Day 1 and Day 15 with repeat dosing at~          six months.~   "
227591|NCT00578422|"~     Peripheral Artery Disease involves a buildup of fatty deposits (plaque) within blood vessels~     that can restrict blood flow. Patients who have PAD and claudication (pain in legs during~     exercise due to poor blood circulation) may be eligible for this clinical trial. Three~     primary hypotheses will be tested in this study: (1) IVUS (Intravascular Ultrasound)combined~     with advanced digital image and signal processing provides a sensitive method to determine~     plaque geometry and composition in the human peripheral artery wall; (2) IVUS can discern~     specific arterial wall morphology, providing data that can be used to identify plaques that~     predispose the patient to late complications; and (3) IVUS-derived plaque structure can be~     used to predict responders and non-responders to pharmacologic therapy and percutaneous~     endovascular interventions. These hypotheses will be tested as follows: (1) custom engineered~     IVUS analysis software will be used to describe the geometry, composition, and spatial~     component relationships of the vessel, (2) the morphology of lower extremity arterial plaque,~     as determined by IVUS, will be correlated with baseline clinical characteristics of subjects,~     and (3) the effects on plaque morphology after long term treatment with antihyperlipidemics~     will be determined.~   "
227583|NCT00578552|"~     Gabapentin is an anti-epileptic agent that has shown preliminary evidence of efficacy for~     improving symptoms of cocaine and alcohol withdrawal in pilot studies. Since the neurobiology~     of alcohol, cocaine and nicotine withdrawal is similar, the preliminary evidence of efficacy~     of gabapentin for symptoms of alcohol and cocaine withdrawal suggests, that gabapentin might~     likely help nicotine withdrawal symptoms and thus tobacco abstinence. The effect of~     gabapentin on two of the neurotransmitters, gamma-aminobutyric acid (GABA) and glutamate~     further suggest a potential therapeutic mechanism for gabapentin in tobacco abstinence.~     However, the exact mechanism of action of gabapentin is currently not known. We have recently~     completed an open label pilot trial of gabapentin for tobacco abstinence involving 50~     smokers. The findings from that study provide promising preliminary results and suggest that~     further testing of gabapentin for helping cigarette smokers quit tobacco use is worth~     pursuing. Overall, gabapentin is well tolerated and has low abuse potential.~      Our goal is to evaluate novel, safe, acceptable, and effective therapies that may help~     increase tobacco abstinence rates. Currently, no randomized trials testing the efficacy of~     gabapentin for smoking abstinence have been published. While our previous study provides~     promising evidence regarding the potential efficacy of gabapentin for smoking abstinence, an~     additional dose ranging study is needed prior to pursuing a large randomized trial. The~     primary aim of the dose ranging study will be to obtain additional evidence of efficacy, and~     information on the optimal dose of gabapentin to employ in the larger randomized controlled~     trial.~   "
227584|NCT00578539|"~     Patients have a type of blood cell disorder that is very hard to cure. We are now suggesting~     a treatment that might help patients live longer without disease than other treatment plans~     would. This treatment is known as a stem cell transplant. We believe this may help patients~     as it allows us to give much stronger doses of drugs and radiation to kill the diseased cells~     than we could give without the transplant. We also think that the healthy cells may help~     fight any diseased cells left after the transplant.~      Stem Cells are special mother cells that are found in the bone marrow (the spongy tissue~     inside bones), although some are also found in the bloodstream (peripheral blood). As they~     grow, they become either white blood cells which fight infection, red blood cells which carry~     oxygen and remove waste products from the organs and tissues or platelets, which enable the~     blood to clot. For the transplant to take place, we will collect these stem cells from a~     donor (a person who agrees to donate these cells) and give them to recipient. Patients do~     not have a sibling that is a perfect match, so the stem cells will come from a donor who is~     the best match available. This person may be a close relative or an unrelated person whose~     stem cells best matches the patients, and who agrees to donate stem cells. Before the~     transplant, two very strong drugs plus total body irradiation will be given to the patient~     (pre-conditioning). This treatment will kill most of the blood-forming cells in the bone~     marrow. We will then give the patient the healthy stem cells. Once these healthy stem cells~     are in the bloodstream they will move to the bone marrow (graft) and begin producing blood~     cells that will eventually mature into healthy red blood cells, white blood cells and~     platelets.~      This research study will also use CAMPATH-1H as a pre-treatment. CAMPATH-1H is an antibody~     against certain types of blood cells. CAMPATH-1H is important because it stays active in the~     body for a long time after infusion, which means it may work longer at preventing GvHD~     symptoms.~      The stem cell transplant described above is considered to be standard treatment. We would~     like to collect additional blood as described below in order to evaluate how the immune~     system is recovering.~      We are asking permission to draw blood from the patient so that we can measure the number of~     certain blood cells called T regulatory cells. T regulatory cells are special immune cells~     that can control or regulate the body's immune response. We want to determine whether T~     regulatory cells are important participants in graft versus host disease (GVHD), infection~     and relapse. In GVHD, certain cells from the donated marrow or blood (the graft) attack the~     body of the transplant patient (the host). GVHD can affect many different parts of the body.~     The skin, eyes, stomach and intestines are affected most often. GVHD can range from mild to~     life-threatening. We do not know whether T regulatory cells can modify these conditions. We~     want to measure these T regulatory cells and learn if these cells do influence these~     conditions. If we learn that T regulatory cells do affect these conditions, then it may be~     possible to modify these cells for the benefit of transplant patients.~   "
227585|NCT00578526|"~     The purpose of this study is to find out if SU011248 works and if it is safe in patients with~     advanced transitional cell carcinoma.~   "
227586|NCT00578500|"~     Success rates of cancer treatment have increased significantly resulting in many girls and~     young women who are treated now and will be cancer survivors. Nevertheless, cancer treatment~     may result in long term side effects. Damage to the ovaries may result in serious difficulty~     to become pregnant in the future. The risk of this happening depends, among others upon~     patient's age, disease and type of treatment she undergoes. Medical research is continuously~     looking into ways to preserve female fertility by using less toxic protocols. Yet, keeping~     your eggs outside the body during treatment is an interesting option which as is routine for~     boys preserving sperm before cancer treatment. This research attempts to freeze eggs either~     in the ovarian tissue or individually.~   "
227587|NCT00578474|"~     The purpose of this study is to determine if an otic formulation is safe and effective in~     treating middle ear infections in patients with ear tubes.~   "
227588|NCT00578461|"~     Patients are being asked to participate in this study because they have a cancer in their~     blood (such as leukemia or lymphoma) or myelodysplastic/myeloproliferative (pre-leukemia). We~     suggest a treatment that might help them live longer without disease than other treatment~     plans would. This treatment is known as a stem cell transplant. We believe this may help the~     patient as it allows us to give much stronger doses of drugs and radiation to kill the~     diseased cells than we could give without the transplant. We also think that the healthy~     cells may help fight any diseased cells left after the transplant.~      Stem Cells are special mother cells that are found in the bone marrow (the spongy tissue~     inside bones), although some are also found in the bloodstream (peripheral blood). As they~     grow, they become either white blood cells which fight infection, red blood cells which carry~     oxygen and remove waste products from the organs and tissues or platelets, which enable the~     blood to clot. For the transplant to take place, we will collect these stem cells from a~     donor (a person who agrees to donate these cells) and give them to the patient. The patient~     has a type of blood cell cancer or other blood problem that is very hard to cure with~     standard treatments and they will receive a stem cell transplant (SCT). If they have a~     brother or sister that is a perfect match and agrees to donate, the stem cells will come from~     him/her. Before the transplant, two very strong drugs plus total body irradiation will be~     given to the patient (pre-conditioning). This treatment will kill most of the blood-forming~     cells in the bone marrow. We will then give the patient the healthy stem cells. Once these~     healthy stem cells are in the bloodstream they will move to the bone marrow (graft) and begin~     producing blood cells that will eventually mature into healthy red blood cells, white blood~     cells and platelets.~      Also, we will ask permission to draw blood from the patient so that we can measure the number~     of certain blood cells called T regulatory cells. T regulatory cells are special immune cells~     that can control or regulate the body's immune response. We want to determine whether T~     regulatory cells are important participants in graft versus host disease (GVHD), infection~     and relapse. In GVHD, certain cells from the donated marrow or blood (the graft) attack the~     body of the transplant patient (the host). GVHD can affect many different parts of the body.~     The skin, eyes, stomach and intestines are affected most often. GVHD can range from mild to~     life-threatening. We do not know whether T regulatory cells can modify these conditions. We~     want to measure these T regulatory cells and learn if these cells do influence these~     conditions. If we learn that T regulatory cells do affect these conditions, then it may be~     possible to modify these cells for the benefit of transplant patients.~   "
227589|NCT00578448|"~     The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de~     novo renal transplant subjects treated with belatacept-based immunosuppressant medication~   "
227590|NCT00578435|"~     The purpose of this study is to determine and confirm the role of bone marrow transplantation~     in the treatment of disorders of the red cell and hemoglobin including sickle cell anemia,~     thalassemia and diamond blackfan anemia.~   "
227592|NCT00578409|"~     We seek to improve the predictive accuracy of the nomogram to predict survival for patients~     with castrate mets disease through the addition of pathological data, the results of~     automated machine vision based image analysis of H&E stained tumor tissue developed at Aureon~     Biosciences,and molecular biomarker studies (25 markers) determined by immunohistochemistry~     on tissue microarrays prepared from paraffin-embedded tumor.~   "
227595|NCT00578370|"~     Ciclosporin is a cyclic nonribosomal polypeptide of 11 amino acids produced by the fungi~     Tolypocladium inflatum and Cylindrocarpon lucidum. Ciclosporin is a highly efficient~     immunosuppressant drug widely used in post-allergenic organ transplant to reduce the activity~     of the subject's immune system and so the risk of organ rejection. Apart from transplant~     medicine, ciclosporin is also used in the treatment of autoimmune diseases like psoriasis and~     infrequently in rheumatoid arthritis and related diseases, although it is only used in severe~     cases.~      Ciclosporin blocks the lymphocytes, especially the T-lymphocytes, in the G0- or G1-phase of~     the cell cycle. Moreover it inhibits the production and release of lymphokines including~     interleukin 2 or the T-cell growth factor.~      Generally ciclosporin is taken orally (capsule or solution)or by injection in doses of 1.5 to~     5.5 mg/kg/day. In the topical cutaneous emulsion presented here, ciclosporin is available at~     a concentration of 0.5 and 1.5%.~      The purpose of this study is the demonstration of antipsoriatic efficacy and tolerability of~     topical cutaneous ciclosporin in subjects with psoriasis vulgaris.~   "
227596|NCT00578357|"~     The main aim of this randomized controlled trial is to evaluate the sustained efficacy of a~     personalized feedback intervention for problem gamblers. Adult problem gamblers who express~     an interest in self-help materials for gamblers will be recruited from respondents to a~     random digit telephone survey, which also collects the baseline data. Subjects will be~     randomly assigned to receive personalized feedback about their gambling, or to a waiting list~     control group.~      Three-month, six-month, and 12-month follow-up surveys will be conducted by mail to assess~     gambling over the intervening periods. Collaterals will be requested as part of the 12-month~     follow-up and interviewed by telephone. Gambling at three- six- and 12-months will be~     compared between the groups. Change in perception of gambling norms and sex will be tested as~     mediational and moderating variables.~   "
227597|NCT00578344|"~     Patients are being asked to participate in this study because they have severe sickle cell~     anemia (SCD) with or without the beta thalassemia trait. Sickle cell anemia is an illness~     where the red blood cells change shape and can clog up blood vessels. This keeps the body~     from getting the oxygen it needs. Thalassemia is when the body does not make enough~     hemoglobin, something that helps the oxygen get to the places it needs to go in the body. The~     patient may or may not need to get regular blood transfusions (getting more blood) to improve~     their quality of life (feel better) and prevent organ damage (problems with the brain, heart,~     lung, kidney, and gonad, for example.). The transfusions can also cause problems, including~     iron overload (too much iron in the blood), which can be fatal (patients can die) without~     regular deferoxamine shots. Even with the best usual treatments, people with thalassemia or~     SCD die sooner. There is no proven cure.~      We would like to treat patients using bone marrow transplantation, a treatment that has been~     used for people with SCD. The transplant uses healthy matched bone marrow. This comes from~     a brother or sister who does not have sickle cell disease or severe thalassemia. If the~     treatment works, the sickle cell disease or thalassemia may be cured. This treatment has been~     used to treat patients with sickle cell disease or thalassemia. It has worked in most cases.~     We hope, but cannot promise, that the transplanted marrow will make healthy cells, and~     patients will not have sickle cell disease or severe thalassemia anymore.~      We do not know what effect this treatment will have on the damage that has already been done~     by the disease. Finding that out is the main reason for this study. Currently, very little~     has been reported about organ function after bone marrow transplants in patients with sickle~     cell anemia.~   "
227598|NCT00578331|"~     The purpose of this study is to determine whether olopatadine nasal spray is safe and~     effective when used for up to one year by patients with perennial allergic rhinitis.~   "
227599|NCT00578318|"~     The purpose of this study was to better understand how African American families identify and~     treat emotional and behavioral concerns associated with depression in their adolescent youth.~     The goals of the study included (a) identifying factors associated with participation in~     psychiatric research and treatment and (b) developing an intervention to increase~     participation in psychiatric research and treatment.~   "
227600|NCT00578305|"~     This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of~     progression of structural joint damage in participants with active rheumatoid arthritis who~     had an inadequate clinical response to methotrexate. Participants were randomized to receive~     rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15~     every 24 weeks in the main study; all participants received concomitant methotrexate at a~     stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were~     provided to eligible participants. Structural joint damage was assessed by magnetic resonance~     imaging (MRI) at baseline and at intervals during the study.~   "
227601|NCT00578292|"~     Patients have severe beta-thalassemia or one of the thalassemia variants. Thalassemia is a~     hereditary disease in which the bone marrow produces abnormal red blood cells that have a~     shorter life span than normal red blood cells. Because of that, the patient has chronically~     low red blood cell numbers (anemia) and need regular blood transfusions to help the patient~     feel better and to help prevent damage to important organs such as the heart. The following~     treatments are currently available to patients: lifelong blood transfusions and drugs that~     help remove iron from the body, and long-term antibiotics to prevent infections. These~     treatments are difficult for patients to take, and do not stop the effects of the disease.~      Currently, the only treatment that may cure thalassemia is bone marrow or blood stem cell~     transplantation. Special blood or bone marrow cells from a healthy person might allow the~     bone marrow to create healthy cells, which will replace the abnormal red blood cells of~     thalassemia. There is a lot of experience using special blood or bone marrow cells from a~     healthy brother or sister who is the same HLA (immune) type. For patients who do not have~     such a donor in the family, an unrelated volunteer donor can be used. It is important for the~     patient to realize that this kind of transplant can have more problems than a transplant from~     a brother or sister.~      Because we do not know the long-term effects of this treatment and because this type of~     transplant has not been used often for people with thalassemia, this is a research study. We~     hope, but cannot promise, that the transplanted marrow/stem cells will produce healthy cells~     and the patient will no longer have severe thalassemia.~   "
227602|NCT00578279|"~     The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic~     ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or~     unresectable pancreatic adenocarcinoma.~      Hypotheses:~        1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving~          pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.~        2. Effective pain relief obtained from EUS-CPN will be related to better quality of life~          (QOL)~   "
227616|NCT00578084|"~     The purpose of this repository is to prospectively examine subjects with known or suspected~     lung cancer to determine the extent of mediastinal lymph node involvement with respect to~     primary lung cancer location. The data collected in this repository may be used to influence~     our current standard of care and streamline indications for EUS.~   "
227603|NCT00578266|"~     For patients with severe aplastic anemia (SAA) who have failed to respond to~     immunosuppressive therapy and lack an HLA identical family member, our objectives are to make~     an initial assessment of the safety and efficacy of allogenic stem cell transplantation from~     either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen~     of Cytoxan, reduced total body irradiation (TBI) and Campath IH. The principle measures of~     safety and efficacy will be :~        1. Patient survival probability at 100 days, 1 year and 2 years.~        2. Incidence of graft versus host disease (GVHD), as well as incidence of acute GVHD and~          chronic GVHD within 6 months and 2 years.~        3. Engraftment at 6 months, 1 year and 2 years~   "
227604|NCT00578240|"~     The Genitourinary Oncology/Urology Services at Memorial Sloan-Kettering Cancer Center (MSKCC)~     participates in research for the control, treatment, and cure of cancer. The purpose of this~     study is to collect normal and cancerous tissues, in addition to blood, and other body fluid~     samples from men with prostate cancer or prostatic disease. These samples may be stored for~     future use or used immediately by researchers who study prostate cancer and try to find~     better ways to diagnose, prevent, and treat it. We will look for genetic changes and protein~     markers on these cells. We hope to learn more about what makes some people get prostate~     cancer, why some cancers are more aggressive than others, and why some cancers respond to or~     resist different treatments. We may also try to grow the tumor cells in the lab. We may find~     a new treatment for prostate cancer based on this research.~   "
227605|NCT00578227|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and~     thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical~     cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent~     vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and~     immunogenicity of co-administering a commercially available vaccine with GSK Biologicals'~     HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine~     alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.~   "
227606|NCT00578214|"~     Midazolam is an approved sedative medication used for medical procedures. This study was~     being done to document the safety and efficacy of midazolam in improving anxiety, heart rate,~     and blood pressure in patients prior to undergoing Mohs micrographic surgery for the~     treatment of skin cancer (basal cell carcinoma or squamous cell carcinoma). Midazolam may~     make a patient relaxed and sleepy, and lower blood pressure. These effects last for about 2~     hours.~      This study had two parts. In the first part, eligible patients were randomized to either~     receiving one standard dose of midazolam syrup or placebo syrup before their surgery, with~     neither the patient nor the study team knowing which patient received the study drug. In the~     second part, patients who were not eligible to participate in the randomized study or who~     refused to participate in the randomized study were enrolled in a prospective arm where they~     knew they were receiving midazolam syrup. In the prospective arm, the doses were based on the~     patient's weight, and patients were given additional doses of midazolam syrup as necessary to~     control their anxiety.~      The primary hypothesis of this study was that a single dose of oral midazolam syrup to~     patients prior undergoing outpatient Mohs micrographic surgery for skin cancer would result~     in lower anxiety scores at 60 minutes compared to placebo. In addition, the second hypothesis~     of this study was that patients given oral midazolam would have the rate of adverse events~     that was not worse than 25% higher than in the placebo group.~   "
227607|NCT00578201|"~     This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when~     given together with Cetuximab and radiation therapy and radiation therapy to see how they~     work in treating patients with stage III esophageal cancer.~   "
227608|NCT00578188|"~     The purpose of this study is to determine if Chlamydial infections persist in the rectum of~     females who have had a sexually transmitted infection of Chlamydia.~   "
227609|NCT00578175|"~     The purpose of this observer blinded study is to provide information on vaccine~     immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when~     administered with Hepatitis A vaccine and Pneumococcal vaccine.~   "
227610|NCT00578162|"~     To describe the range of services available to cancer survivors in the NYC area.~      To determine organizations' need for assistance to enhance services for survivors.~   "
227611|NCT00578149|"~     This study is being done to learn what effects (good and bad) bevacizumab in conjunction with~     carboplatin/paclitaxel and radiation therapy has on patients with non-small cell lung cancer~     (NSCLC).~   "
227612|NCT00578136|"~     Umbilical hernia repair is a common painful outpatient procedure performed in children. Often~     analgesia for this procedure is provided by using local infiltration of the surgical site by~     the surgeons and perioperative opioids and NSAIDS both IV and orally. The use of opioids can~     cause adverse side effects which include, but are not limited to nausea, vomiting, itching,~     and respiratory depression, etc. The rectus sheath block can be performed in these patients~     to decrease their post operative pain.~   "
227613|NCT00578123|"~     The goal of the study is to look at surgical recovery and quality of life for men who have an~     open versus robotic-assisted laparoscopic radical prostatectomy (RP). RP is a procedure that~     removes the prostate gland. We want to see how long it will take you to return to health and~     strength after surgery. Quality-of-life (QOL) means how you feel about your life and your~     treatment of prostate cancer. The QOL surveys ask questions about your sexual, urinary and~     bowel functions. We will also ask questions about your use of health care services,~     out-of-pocket-spending on medical care and about your return to work, in order to learn about~     the financial impact of prostate cancer treatment. We hope that the surveys will help show~     how prostate cancer treatments affect your daily life after surgery.~   "
227614|NCT00578110|"~     To introduce a rapid and objective electrophysiological technique that can assess visual~     function in the magnocellular pathway, which is thought to be affected in early-stage~     glaucoma.~   "
227615|NCT00578097|"~     The purpose of this study is to determine the optimal dose of botulinum toxin type A injected~     in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life~     of continent women suffering from idiopathic overactive bladder.~   "
227660|NCT00577473|"~     The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg~     tablet) versus Asacol 2.4 g/day (400 mg tablet~   "
227617|NCT00578071|"~     The primary purpose of this trial is to define the maximum tolerated and/or recommended phase~     II dose of the combination of panitumumab, oxaliplatin and capecitabine in patients~     undergoing radiation therapy for carcinoma of the thoracic esophagus or gastroesophageal~     junction. An additional primary objective is to describe the frequency and nature of grade~     III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include~     describing 1-year disease-free survival and overall survival rates as well as to estimate~     clinical and pathologic complete response rates associated with this regimen.~   "
227618|NCT00578058|"~     Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment~     that has been shown to be effective in controlled investigations. The purpose of this study~     is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). This study will~     investigate the contributions of counseling, the use of hearing aids and sound generators,~     and the importance of setting masking noise to a particular level. All groups will receive~     the same Counseling. In pilot studies we have developed a picture-based counseling protocol.~     The results of this study will determine if TRT is more effective than masking or counseling~     alone.~   "
227619|NCT00578045|"~     The researchers want to find out if subjects treated on this study will achieve long term~     bone marrow recovery (engraftment) and if their tumors will respond to this treatment.~   "
227620|NCT00578032|"~     The goal of this study is to better understand the changes in symptoms and overall quality of~     life after head and neck surgery and reconstruction. Quality of Life means how you feel~     about your life as a result of your disease and its treatment. Learning about changes in~     patients' quality of life will help doctors and future patients make more informed treatment~     decisions.~   "
227621|NCT00578019|"~     The purpose of this study is to compare patient outcomes for the Less Invasive Stabilization~     System (LISS) (Synthes {USA}, Paoli, PA, USA), a minimally invasive plating system used in~     the treatment of supracondylar femur fractures, with patient outcomes for the Supracondylar~     Nail (Smith & Nephew Inc, Memphis, TN, USA), a retrograde intramedullary nail.~   "
227622|NCT00578006|"~     Cancer patients may develop side effects during treatment, such as nausea, pain, fatigue,~     diarrhea, constipation, or shortness of breath. These symptoms may be due to the cancer~     itself, or due to treatments like chemotherapy drugs or radiation therapy. Doctors and nurses~     often ask patients about their symptoms, because an important part of cancer treatment is to~     make patients feel as well as possible. If patients do not feel well, the investigators may~     need to change the way the investigators are treating you or prescribe therapies that will~     decrease your symptoms. The best way to find out how you are feeling is to ask you directly.~      However, during your time between appointments the investigators may not be able to ask you~     how you are feeling on a regular basis. In addition, even at an appointment, there may be~     symptoms that the investigators do not have a chance to discuss.~      The investigators are interested in developing new ways to ask patients about how they are~     feeling, using the Internet. A special new website called STAR (Symptom Tracking and~     Reporting for Patients) has been developed to help patients record this information, so that~     their doctors and nurses can review it during clinic appointments. This study is designed to~     help us see if STAR is a helpful way for us to keep track of information about patients'~     symptoms and quality of life.~   "
227623|NCT00577993|"~     The goal of this clinical research study is to compare chemotherapy given with rituximab to~     chemotherapy followed by rituximab. The safety of both treatment schedules will be studied.~     Laboratory tests of genetic changes in blood and bone marrow before and during the study will~     also be monitored.~   "
227624|NCT00577980|"~     Primary Objective:~      1. To assess the prostate-specific antigen (PSA)-response (50% decline) to Testosterone~     Replacement Therapy (TRT) in men with intermediate and good-risk Castration-Resistant~     Prostate Cancer (CRPC).~      Secondary Objectives:~        1. To assess the objective response and time-to-progression with TRT in CRPC.~        2. To assess serial changes in quality of life with TRT in these CRPC subsets.~        3. Translational: To study kinetics of circulating tumor cells with TRT and molecular~          correlates of response to TRT in CRPC.~   "
227625|NCT00577967|"~     To investigate using the drug gabapentin to relieve the intense pruritic sensation associated~     with chronic renal failure patients undergoing peritoneal dialysis.~   "
227626|NCT00577954|"~     Stroke, traumatic head injury, subarachnoid hemorrhage and cerebral anoxia are main causes of~     a coma condition implying severe brain damage and thus, poor prognosis. Clinicians are often~     in need for a tool able to predict the awakening of these patients. Multimodal MRI,~     associating the traditional morphological sequences with spectroscopy-MRI (MRS) and the~     diffusion tensor imaging, could provide such a prediction.~   "
227627|NCT00577928|"~     For the main goal - the accuracy of calprotectin for the diagnosis of IBD - calprotectin~     levels will be compared between patients with and without a diagnosis of IBD and the~     sensitivity, specificity and accuracy will be determined. For the secondary aim - the~     correlation between calprotectin levels and disease activity - in patients with IBD selected~     from this cohort, we will determine the association between calprotectin levels and clinical~     IBD score, serological markers (WBC, Hgb, Platelets, ESR, CRP, Albumin), endoscopic (disease~     score, pathological activity) and radiological features (bowel wall thickening, enhancement,~     edema, mesenteric inflammation).~   "
227628|NCT00577915|"~     The purpose of this study is to provide physicians with additional information not available~     with standard imaging methods for breast disease.~      As part of the MRI examination ordered by your physician, a new method of analyzing the~     images or pictures will be used. This new method is called spectroscopy and is used routinely~     on other parts of the body such as the prostate and brain. Pictures produced with this~     sequence may look slightly different than the regular MRI pictures. Using spectroscopy data,~     it may be possible to distinguish benign conditions of the breast from malignant tumors and~     provide more precise information than can be obtained with regular MRI.~   "
227629|NCT00577902|"~     This study is being conducted to define the specific nutritional biomarkers and nutritional~     risk during the course of chemoradiation therapy for cancers of the head and neck. This~     prospective, longitudinal observational study is focused on specific antioxidants and B~     vitamins. The ORAC was selected as an index of overall antioxidant capacity. We chose to~     evaluate antioxidant status because administering antioxidants has been shown to reduce~     chemotherapeutic agent toxicities.~   "
227630|NCT00577889|"~     This randomized phase II trial is studying three different schedules of gemcitabine~     hydrochloride and tanespimycin to see how well they work in treating patients with stage IV~     pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and~     tanespimycin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells~   "
227631|NCT00577876|"~     For patients with Prostate Cancer advances in medical technology have enabled us to identify~     accessory (additional) pudendal arteries (called APA) while performing a laparoscopic~     radical prostatectomy (a scope with a video camera is used during the surgery). APAs running~     near the prostate gland are identified in approximately 1 in 3 to 4 patients. However, large~     APAs, like the ones looked for in this study, are identified in 15-18% of all patients. These~     arteries are preserved more than 80% of the time, depending on their size and location.With~     this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as~     well as the amount supplied.~   "
227632|NCT00577863|"~     This study is being conducted to collect information from subjects with osteoporosis~     regarding their experience using the Forteo B Pen to self-administer teriparatide in the~     community setting. Information collected during this study will be used to assess the need~     for changes to the Forteo B-Pen User Manual and patient educational tools. Additionally, the~     information generated from patients during this trial will be reviewed to assess the~     acceptability of the Forteo B Pen for commercial launch.~   "
227633|NCT00577850|"~     The primary objective of this study is to compare the urinary excretion of 14C-labeled~     risedronate and alendronate over 28 days.~   "
227634|NCT00577837|"~     A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized,~     Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150,~     and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with~     Low Bone Mineral Density.~   "
227635|NCT00577824|"~     This long term, placebo-controlled trial is intended to assess the efficacy and safety of~     exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with~     oral antidiabetic(s) but not well controlled.~   "
227636|NCT00577811|"~     The purpose of this study is to find out how people's needs are being met and what people do~     about problems with treatment, symptoms, substance use, mental health, and social services.~     We are also interested in finding out about changes that people make in their health care~     team and the reasons for making those changes.~   "
227637|NCT00577798|"~     RATIONALE: Diagnostic procedures, such as cardiac magnetic resonance imaging, may help~     doctors detect early changes in the heart caused by chemotherapy.~      PURPOSE: This clinical trial is studying how well cardiac magnetic resonance imaging works in~     patients with newly diagnosed non-Hodgkin lymphoma or Hodgkin lymphoma receiving doxorubicin.~   "
227638|NCT00577785|"~     The objective of this study is to obtain bladder tissue specimens from patients otherwise~     undergoing cystectomy for use in research and training of personnel at Tengion, Inc.~   "
227639|NCT00577772|"~     The primary purpose of this exploratory study is to measure orocecal transit time using the~     SmartPill ambulant capsule technology and to compare this with the lactulose hydrogen breath~     test. Additionally, the ability of the SmartPill GI Monitoring System to discriminate between~     healthy human subjects and patients with small bowel bacterial overgrowth will be explored~     using analyses of both pH and pressure patterns within the stomach and small intestine. The~     study will be performed in both normal subjects and patients with and without small bowel~     bacterial overgrowth.~   "
227640|NCT00577759|"~     The purpose of this study is to evaluate the impact of strategies to develop and foster the~     relationship between primary care practices and community resources to address specific~     unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).~   "
227641|NCT00577746|"~     The goal of this prospective study is to determine the clinical and economic impact of~     endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in~     staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo~     surgery 4) Determine the cost benefit of EUS in staging NSCLC.~   "
227642|NCT00577733|"~     Asthma is more frequent in obese women, but the mechanisms underlying the causes of this~     increased frequency are unknown and are different from usual asthma pathophysiology~     (associated with allergy). Obesity is known to influence ventilation; our hypothesis is that~     the normal variability of ventilation is decreased in obese patients, and that this decrease~     is responsible for an increased reactivity of their airway to non specific stimuli. In this~     observational study, breathing variability will be studied using polygraphy (an investigation~     that is made in these women to detect nocturnal apneas), and airway reactivity is studied~     between pulmonary function tests that are made before bariatric surgery.~   "
227643|NCT00577720|"~     To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after~     breakfast, to a 35 mg immediate-release tablet, administered according to labeling~     instructions.~   "
227644|NCT00577707|"~     The purpose of this study is to try to improve the odds that your cancer may be cured.~     Pemetrexed and cisplatin are traditional chemotherapy drugs that have been shown to help some~     patients with non-small cell lung cancer. Many different types of cancer cells, including~     your type of lung cancer, have a protein on their surface called the epidermal growth factor~     receptor (EGFR). Stimulation of these receptors can result in growth of cancer cells and~     progression of cancer. In addition, your cancer has an EGFR mutation (a specific abnormality~     in the genetic code for EGFR). Erlotinib (TarcevaTM) is a newer drug which has shown benefit~     for patients with lung cancers that contain an EGFR mutation. Erlotinib works by blocking~     this receptor and depriving the cancer cells of this message to grow and multiply. In this~     research study, we plan to combine erlotinib with traditional chemotherapy drugs to see if~     the combination works better than chemotherapy alone.~      The main purpose of this research is to find out the good and bad effects that the~     combination of these 3 drugs (pemetrexed, cisplatin and erlotinib) has when given to patients~     with early stage non-small cell lung cancer before surgery. A secondary purpose is to find~     out the good and bad effects that occur when erlotinib is given to patients after surgery for~     2 years.~   "
230336|NCT00541619|"~     The primary objective of the study is whether subjects with hypertension and proteinuria~     display increased sympathetic nerve activity compared to hypertensive subjects without~     proteinuria and normotensive controls.~   "
227645|NCT00577694|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Giving clofarabine together with gemtuzumab~     may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when~     given together with gemtuzumab in treating patients with relapsed or refractory acute myeloid~     leukemia.~   "
227646|NCT00577681|"~     HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease for~     which there is not yet a cure. Antiretroviral therapy (ART) has proven an effective treatment~     for inhibiting the replication of HIV, allowing for improved quality of life and survival.~     Previous studies indicate that episodic use of ART is associated with increased risk of~     cardiovascular disease (CVD). This study will determine mechanisms underlying the increased~     CVD risk among people infected with HIV and, specifically, in those who receive episodic ART.~   "
227647|NCT00577668|"~     In this study, researchers want to find out if using the VTD regimen, along with higher doses~     melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be~     given safely to subjects who have failed previous transplant(s).~   "
227648|NCT00577655|"~     The primary objective of this study is to evaluate the chronic-dose and efficacy of~     Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.~   "
227649|NCT00577642|"~     The purpose of this research study is to define the time a molecule in the participants bones~     called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in~     the urine to determine the rate of bone breakdown. Tracking this marker may help identify a~     more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic~     acid, which will be used in this study, are used to reduce pain and bone fractures in people~     with multiple myeloma. There is some laboratory data to suggest that they may work against~     myeloma. Participants will have already undergone bisphosphonate therapy and may have~     received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due~     to concerns of their long-term side effects we are looking at alternate strategies for~     reducing the frequency of these agents.~   "
227650|NCT00577629|"~     The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal~     antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients~     with high-risk Non-Hodgkin's Lymphoma (NHL).~   "
227651|NCT00577616|"~     The aim of this multicenter randomized trial is to compare the endovascular repair versus~     conventional repair for ruptured aorta-iliac aneurysms observed on CT scan in stable patients~     with suitable anatomy. The main awaited result is the significant reduction of the mortality~     of the conventional repair.~   "
227652|NCT00577603|"~     This study is being done to evaluate the use of a material (Alloderm collagen mesh) during~     the stomal formation operation (surgery that will create a mouth-like opening on the surface~     of the body to an internal organ). The main purpose of this research study is to see if using~     this material will lower the hernia rate compared to normal repair without this material. The~     secondary purpose is to evaluate if using this material will increase or decrease~     complication rates.~   "
227653|NCT00577590|"~     Type 2 diabetes mellitus (T2DM) is a disease that interferes with the body's proper~     production and use of insulin, a hormone needed to convert sugar into usable energy. People~     with T2DM are at a higher risk for certain cardiovascular diseases, including heart disease~     and stroke. Normal treatments for T2DM target blood sugar levels only, but there is reason to~     believe that also targeting blood fat levels will improve both sugar metabolism and heart~     function in people with T2DM. This study will determine the effectiveness of blood-fat~     lowering treatments along with blood-sugar control treatments in improving heart function and~     symptoms of people with T2DM.~   "
227654|NCT00577577|"~     To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance,~     ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and~     strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients~   "
227655|NCT00577564|"~     The purpose of this retrospective study is to measure the safety of EUS-CPN in patients that~     have undergone this procedure in the last decade.~   "
227656|NCT00577538|"~     Patients with inflammatory bowel disease (IBD) may be at increased risk of lymphoma. The~     majority of lymphomas in patients with IBD occur in areas of active inflammation. The~     relationship between IBD and lymphoproliferative disease is however unclear, since both~     chronic inflammation as well as medications used to treat IBD (especially immunosuppressives~     - Azathioprine or 6-MP - and anti-TNF alpha agents) have been associated with increased risk~     of lymphoma. We plan to study the association between IBD and lymphoma in a large, mixed,~     community based and referral population from the IBD database at Indiana University.~   "
227657|NCT00577525|"~     The primary purpose of the study is to evaluate the association of a latent infection of~     lymphoid cells during the first manifestation of steroid sensitive nephrite syndrome. The~     thirty nine units of general pediatrics and pediatric nephrite covering the parisian area~     will participate to the study. We speculate that hybridization of the genome, or a part of~     the genome, of a virus in lymphoid cells is responsible specific changes of genes expression,~     leading to the development of the disease.~   "
227658|NCT00577512|"~     This study is being done in an attempt to improve the remission rate and the survival time~     for subjects with high-risk myeloma. It is hoped that by giving higher doses of commonly used~     chemotherapy drugs and by giving courses closer together (before the myeloma comes back or~     gets worse), subjects in this study will have better outcomes.~   "
227659|NCT00577499|"~     Cystic fibrosis (CF) results in thickened secretions in multiple organ systems including the~     lungs and gastrointestinal (GI) tract. Patients commonly suffer from nutritional deficiency,~     and achieving and maintaining adequate nutrition is an important goal of therapy because it~     is positively correlated with lung function. Lubiprostone activates chloride channels in the~     GI tract. Because its mechanism of action closely parallels the disease pathology,~     lubiprostone has the potential to provide GI benefits beyond the relief of constipation. This~     project is an observational study to examine the effects of lubiprostone on nutritional~     status and lung function in adults with CF. Our hypothesis is that lubiprostone will have~     beneficial effects on nutritional status.~   "
227665|NCT00577408|"~     In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the~     new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide~     initial clinical experience with the new Depot-BNT treatment model, while providing a~     rigorous test of whether Depot-BNT produces superior treatment outcome, compared to our best~     behavioral platform for oral naltrexone (BNT).~      The following aims will be addressed:~      Specific Aim #1: To test whether Depot-BNT increases retention in treatment and improves drug~     use outcome (urine-confirmed abstinent weeks) compared to our established model of BNT with~     oral naltrexone (BNT-Oral), and to explore whether Depot-BNT (vs BNT-Oral) improves key~     secondary outcomes including dysphoria, HIV risk behavior, and social functioning.~      Specific Aim #2: To explore predictors of outcome on Depot-BNT, and mechanisms of attrition,~     in order to optimize Depot-BNT prior to further testing.~   "
227666|NCT00577395|"~     The purpose of this trial is to compare the difference in bone microarchitecture of the~     distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg~     taken once a month compared to placebo.~   "
227667|NCT00577382|"~     The purpose of this study is to evaluate how effective Sunitinib works in treating acral~     lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a~     protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work~     by blocking signals on certain cancer cells which allow the malignant cells to multiply and~     spread due to a change in the genetic make up of the cancer cell.~   "
227668|NCT00577369|"~     In this feasibility study we will collect blood from indwelling arterial catheters in up to~     20 patients undergoing non-emergent surgery with desflurane anesthesia at Children's Hospital~     of Philadelphia. Desflurane levels will be determined by high pressure liquid chromatography~     (HPLC).~      Our eventual goal is to quantify fetal levels of desflurane in umbilical cord blood during~     fetal surgery. We propose a pilot study to assess the ability of our assay to measure~     desflurane in human blood.~   "
227669|NCT00577356|"~     The purpose of this study is to find out what effects, good and bad, the combination of~     docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before~     removal the prostate (prostatectomy).~   "
227670|NCT00577343|"~     Hospital acquired and community acquired methicillin resistant staph aureus (MRSA) has become~     an important health issue for in recent years. Up to two thirds of patients that are~     hospitalized may be colonized with MRSA. The prevalence in the community is also on the rise~     and affects the young and healthy. It is unclear what the true prevalence of MRSA is in our~     own hospital and outpatient setting. This information would be relevant to how healthcare~     staff adhere to contact and universal precautions. : The purpose of this study is to~     determine the prevalence of MRSA in patients that have gastrointestinal endoscopy and~     endoscopic ultrasound.~   "
227671|NCT00577330|"~     Myalgesin is a botanical preparation consisting of celery seed extract,extract of dried~     Boswellia serrata, and dried extract of Phellodendron bark. Component of these extracts have~     been shown to exert anti-inflammatory effects and to inhibit cyclooxygenase and~     5-lipooxygenase. The study is based on the hypothesis that oral administrration of this~     botanical will support joint function in people with osteoarthritis of the knee and improve~     symptoms and mobility as measured by the Western Ontario and McMaster Universities (WOMAC)~     Osteoarthritis Index.~   "
227672|NCT00577317|"~     This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how~     well it works compared with standard home maintenance therapy in treating patients with~     lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or~     endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity~     lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the~     Flexitouch® system is more effective than standard home maintenance therapy in treating~     lymphedema.~   "
227673|NCT00577304|"~     The purpose of this research study is to test the safety, tolerability, and effectiveness of~     Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase~     blood flow to the fingers.~   "
227674|NCT00577278|"~     RATIONALE: Giving monoclonal antibody therapy, radioimmunotherapy, and chemotherapy before a~     donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When the stem cells from a related donor~     that do not exactly match the patient's blood, are infused into the patient, they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can also make an immune response against the~     body's normal cells. Giving tacrolimus and sirolimus before and after transplant may stop~     this from happening.~      PURPOSE: This phase II trial is studying the side effects and how well giving indium In 111~     ibritumomab tiuxetan and yttrium y 90 ibritumomab tiuxetan together with rituximab,~     fludarabine, melphalan, and donor stem cell transplant works in treating patients with B-cell~     non-Hodgkin lymphoma.~   "
227675|NCT00577265|"~     An observational study to investigate how patients experience the ability to adjust their~     asthma maintenance medication according to instructions received from their physician. The~     primary aim is to create an insight in the perception of the patient when he has the ability~     to adjust his own maintenance treatment and how the patient exercises this in the daily~     practice.~   "
227676|NCT00577252|"~     In this research, we will use established surveys to look at the relationship between various~     styles of coping with a disease, religious coping styles, treatment compliance, locus of~     control, broad measures of mental health and adjustment, and basic health data (e.g., PFTs,~     recent hospitalizations or antibiotics within the past year, lung microbiology, CFTR~     mutations, and co-morbid conditions such as diabetes, depression, and liver disease). While~     the research is correlational, it should suggest relationships (both positive and negative)~     between various coping styles and desired outcomes (compliance and well-being).~   "
227677|NCT00577226|"~     The objective of this study is to retrospectively and prospectively review patients who have~     undergone this technique looking at age of the patient, magnitude of the curve~     preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical~     procedures, complications, and spinal growth.~      The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a~     surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for~     natural growth of the spine in a guided fashion with a limited number of future surgeries~     required.~   "
227678|NCT00577213|"~     To develop a non-invasive, simple and affordable, measurement technique to differentiate~     hemangiomas from subtypes of VMS. The purpose of this study is to determine the best office~     based diagnositc instrument for differentiating the subtype of vascular lesions. The~     instrument must be simple and affordable so it can be used by primary car physicians in the~     doctor office. The procedure will be based on non-invasive and unharmful measurements that~     will be compared to the diagnosis from specialized physicians in this field and the final~     pathology.~   "
227679|NCT00577200|"~     Patients are currently advised to refrain from driving motor vehicles or using public~     transportation unescorted for a 24 hour period if they undergo any minor ambulatory surgical~     procedure with monitored anesthesia care (MAC).However, recently introduced short-acting~     anesthetics may facilitate rapid recovery and an early return to normal daily activities. The~     proposed study will compare newer short-acting anesthetic agents (propofol, benzodiazepine,~     opioid) utilized in MAC, to determine if a particular pharmacological agent, or a combination~     of agents, impair driving performance as evaluated by driving simulator assessment, at time~     of discharge from the ambulatory center after minor surgical procedures.Subjects will be~     grouped as patients with chronic pain undergoing procedures and those without chronic pain~     undergoing procedures. Subjects with pain issues will be randomized with either 1)Midazolam +~     Sufentanil + Propofol or 2)Midazolam + Sufentanil. There will be a third group of subjects~     who are controls not undergoing any procedures.~   "
227680|NCT00577187|"~     This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help~     guide the placement of the left ventricular lead during cardiovascular resynchronization~     therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure~     time.~   "
227681|NCT00577174|"~     The prevalence of pediatric obesity is increasing at an unprecedented rate. Obese children~     are at risk for the development of insulin resistance, relative insulin deficiency and type 2~     diabetes mellitus. However, the cause of insulin resistance remains an area of scientific~     interest. The study of type 2 diabetes in children is limited by the lack of a non-invasive~     method to evaluate insulin resistance. Recent studies have suggested that mitochondrial~     dysfunction is associated with, and perhaps predictive of insulin resistance in adult~     relatives of individuals with type 2 diabetes. Mitochondria generate energy in muscle tissue~     through the production of ATP, and are important in the metabolism of both glucose and fat.~     This study evaluates a novel, non invasive, safe method for predicting insulin resistance and~     diabetes in children using a magnetic resonance imaging (MRI) based technique to measure~     mitochondrial function. We propose to investigate mitochondrial function and glucose~     metabolism in obese and non-obese children in early, mid and late puberty. Analyses will be~     conducted to investigate the presence of mitochondrial dysfunction in obese children, to~     evaluate the contribution of mitochondrial dysfunction to insulin resistance, and to~     determine the contribution of pubertal status to mitochondrial dysfunction and insulin~     resistance. The successful completion of this study would provide evidence to support the~     hypothesis that mitochondrial dysfunction plays a role in insulin resistance and diabetes in~     children. In addition, it would provide a new technique for the prediction of disease states~     and perhaps lead to the development of preventative therapeutics for insulin resistance and~     type 2 diabetes in children.~      We hypothesize that mitochondrial dysfunction will mirror the progression of insulin~     resistance and precede and predict abnormal glucose metabolism in a population with pediatric~     obesity~   "
227682|NCT00577161|"~     BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced~     delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent~     has structural similarities to mitoxantrone as well as general similarities to anthracyclines~     (such as the tricyclic central quinoid chromophore7).~      This phase III study will compare the efficacy and safety of the combination BBR 2778,~     fludarabine, and rituximab with the combination fludarabine and rituximab in patients with~     relapsed or refractory indolent non-Hodgkin's lymphoma.~   "
227683|NCT00577148|"~     The purpose of this study is to assess the effect of rimonabant treatment on the histological~     features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.~   "
227684|NCT00577135|"~     Heart failure is a disorder in which the heart does not pump blood adequately. This can lead~     to several serious problems, including reduced blood flow throughout the body, congestion of~     blood in the veins and lungs, and fluid accumulation in various organs and limbs. Diuretics~     are often used to address the problem of fluid accumulation, but the optimal dose and the~     amount of time over which to administer each dose are unclear. This study will compare high~     and low doses of diuretics administered over longer and shorter periods of time to determine~     the safest and most effective combination.~   "
227685|NCT00577122|"~     The purpose of this study is to evaluate the impact of MPA alone and in combination with low~     dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.~   "
227686|NCT00577109|"~     This single arm study will assess the efficacy and safety of a combination of modified~     FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously~     untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan~     180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in~     combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of~     400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study~     treatment is until disease progression or unacceptable toxicity, and the target sample size~     is <100 individuals.~   "
227687|NCT00577096|"~     The purpose of the study was to determine the effect of Epoetin alfa therapy (short term~     versus long term) with and without a home-based individualized exercise program that~     incorporated aerobic and strength resistance training for patients being treated with~     high-dose chemotherapy and autologous peripheral bloodstem cell transplantation (PBSC T) for~     multiple myeloma. The endpoints for the study included the number of attempts at and total~     number of days of stem cell collection, number of RBC and platelet transfusions during the~     transplantation period, time-to-recovery after transplantation, and response to intensive~     therapy for multiple myeloma.~   "
227688|NCT00577083|"~     This is a test in which a thin, black, flexible tube with a lighting system on the end is~     passed through the anus, into the rectum, in order to examine the large bowel or intestine,~     also called the colon. Colonoscopy is a very good test for examining the colon for polyps~     (warty growths that can turn into cancer), but it is not perfect. In fact, about 30% of~     polyps that are under 5 mm (about 1/5 of an inch) in size are missed during colonoscopy~     because they are hiding behind folds and bends in the colon. This research study is being~     done to determine if performing colonoscopy with a cap on the tip of the colonoscope will~     reduce the miss rate for polyps. A cap is a clear plastic hood that fits on the tip of the~     colonoscope and sticks out about 1/3 of an inch. During colonoscopy, the cap can be pressed~     against a fold or ridge in order to flatten it, so that the lining on the other side can be~     more easily seen. This may reduce the miss rate for colon polyps.~   "
230345|NCT00541489|"~     To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of~     signs and symptoms of Osteoarthritis.~   "
227689|NCT00577070|"~     There is a general consensus of efficacy of TMS in treatment of major depression,yet results~     are not satisfying.A new coil (H-coil, recently invented in Weizmann Institute of Science,~     Neurobiology Department, Rehovot, Israel) is supposed to be capable of stimulating deeper~     brain structures than conventional coils.TMS using this coil was named by its developers as~     deep TMS and will hence be refered to by this name.~      So far, deep TMS have studied in Israel with promising sucssess in patients with Major~     depression (An on-going study).A safety study with good results have been recently~     published.The aim of this study is to reinforce initial results in major depression using~     deep TMS.~   "
227690|NCT00577057|"~     The objectives of this clinical study are threefold:~        1. To compare the benefits in cancer control and survival obtained from adding~          induction-concurrent chemotherapy to radiation with those from adding~          concurrent-adjuvant chemotherapy to radiation.~        2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or~          PX, respectively) in the chemotherapy plan will maintain or improve further the~          chemotherapy benefits while reducing the duration of hospital stay.~        3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as~          compared with conventional fractionation radiotherapy.~   "
227691|NCT00577044|"~     The true incidence and prevalence of NAFLD in Hong Kong has not been determined. The natural~     history of NAFLD is not well defined partly because of differences in the exclusion limit of~     alcohol and the required histological criteria between studies. NAFLD is previously believed~     to be a benign non-progressive condition, but it has since been determined that a subset of~     patients can progress to cirrhosis and even hepatocellular carcinoma.~      In fact in a recent histological review of NAFLD, fibrosis or liver cirrhosis was present in~     15-50% of patients at index liver biopsy. The presence of obesity or type 2 diabetes mellitus~     are the strongest predictors of fibrosis. These same risk factors are also more common in~     patients with cryptogenic cirrhosis. Further evidence of the link between diabetes, obesity~     and NAFLD are mainly from the field of liver transplantation. In patients who underwent liver~     transplantation for cryptogenic liver cirrhosis, NAFLD recuured in a quarter of the hepatic~     allografts. The patients with recurrent NAFLD were more likely to be diabetic and had a~     higher body mass index (BMI) at the time of recurrent NAFLD. This suggests that NAFLD may~     have a significant role in the pathogenesis of crytogenic cirrhosis.~      Although NAFLD was initially described as a slowly progressive disease, there are emerging~     data which shows that it can progress rapidly. Liver failure has even been described in~     patients with NAFLD after bariatric surgery, and a recent report described 5 cases of~     subacute liver failure in obese middle aged females with NAFLD related cirrhosis. NAFLD can~     also affect the progression of other diseases as well. Hepatic steatosis related to visceral~     obesity is a major independent risk factor for fibrogenesis related to chronic HCV hepatitis.~      However, the prevalence of NAFLD and its interaction with chronic HBV, if any, is uncertain.~     This study aims to determine the prevalence of NAFLD in patients with unknown cause of~     hepatitis and to determine the histological fibrosis and inflammation in chronic HBV patients~     with NAFLD.~   "
227692|NCT00577031|"~     This single arm study will evaluate the efficacy and safety of a first-line regimen of~     Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or~     rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on~     day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14,~     for a maximum of 6 months. Patients with stable disease or complete or partial response may~     continue on Avastin therapy. The anticipated time on study treatment is until disease~     progression, and the target sample size is 100-500 individuals.~   "
227693|NCT00577018|"~     The purpose of this study is to determine the safety profile of 4 mg prucalopride in the~     treatment of chronic constipation.~   "
227694|NCT00577005|"~     Concurrent dependence on cocaine occurs in up to 50% of the over one million opiate dependent~     patients in spite of methadone maintenance treatment being highly effective for opiate~     dependence and having excellent treatment retention. Cocaine dependence has remained largely~     unresponsive to medications both in and outside of these methadone programs. We have initial~     data from our open-label study with levetiracetam showing that this medication is well~     tolerated and may reduce cocaine use in this cocaine-abusing methadone treated population.~      The specific aim of this study is to evaluate the efficacy of levetiracetam 3 grams/day in~     modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's~     reinforcing effect among methadone-maintained patients. The primary outcomes will be~     reduction in cocaine use as assessed by self-report and thrice-weekly urinalyses. Secondary~     outcomes will include weeks in treatment (retention) and change in measures of cocaine~     craving, anxiety symptoms and opiate withdrawal symptoms.~   "
227695|NCT00576992|"~     The purpose of this study is to evaluate the demographics, patients symptoms, and findings~     during endoscopy. Patients presenting for an endoscopy procedure to the KCVA GI endoscopy~     suite, will be asked to fill out questionnaires pertaining to their symptoms and indications~     for the procedure. This will be done before their procedure during the interview period~     preceding endoscopy. The patient's answers to this questionnaire will aid us in determining~     the prevalence of gastric and esophageal disease in patients presenting with the complaints~     of dyspepsia, GERD, or extraesophageal symptoms and to also determine whether the presence of~     any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above~     endoscopic diagnoses.~   "
227696|NCT00576979|"~     RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as~     etoposide and cyclophosphamide, before a donor stem cell transplant helps stop the growth of~     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. When the healthy stem cells from a donor are infused into the patient they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells. Giving IMRT together with chemotherapy before transplant may stop this from~     happening.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of~     intensity-modulated radiation therapy (IMRT) when given together with etoposide and~     cyclophosphamide followed by donor stem cell transplant and to see how well they work in~     treating patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute~     myeloid leukemia (AML).~   "
227697|NCT00576940|"~     The aim of the study was to assess the clinical effect of immunomodulating enteral nutrition~     in patients undergoing resection for gastrointestinal cancer. 196 subjects were randomly~     assigned into two study groups: standard and immunostimulating. The study failed to~     demonstrate any clear advantage of routine postoperative immunonutrition in patients~     undergoing elective upper gastrointestinal surgery~   "
227737|NCT00576420|"~     The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor~     Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D~     500 s-apr) for hemostasis in participants receiving prosthetic expanded~     polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual~     compression with surgical gauze pads.~   "
227698|NCT00576927|"~     Older people living in nursing homes do not sleep very well for many reasons. Sleep disorders~     such as sleep apnea (when someone briefly stops breathing during sleep), and night time~     urination, along with the problems caused by the nighttime environment of the nursing home,~     such as noise and disruptive care routines can all contribute. Poor sleep can lead to other~     health problems or make existing health problems worse.~      This study will evaluate how well a sleep hygiene intervention and a medication for sleep~     (ramelteon (Rozerem)) work to improve sleep in nursing home residents with poor sleep.~     Ramelteon is FDA approved and has been tested in older adults living in the community, but~     not in older adults living in nursing homes. We expect sleep to improve on the study drug~     along with the sleep hygiene intervention, in comparison to placebo along with the sleep~     hygiene intervention. Based on adverse events reported in previous samples of older subjects,~     we expect the study drug to cause few side effects.~   "
227699|NCT00576914|"~     This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar~     prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with~     completely resected IB-IIIA non-small-cell lung cancer.~      The patients with completely resected stage IB to stage IIIA non-small cell lung cancer were~     randomly assigned to the group of vinorelbine plus cisplatin plus endostar or to the group of~     vinorelbine plus cisplatin . The primary end point was overall survival; principal secondary~     end points were recurrence-free survival and the toxicity and safety of the regimens.~   "
227700|NCT00576901|"~     This single arm study will assess the efficacy and safety of combination first-line treatment~     with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast~     cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each~     cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2~     p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional~     additional two cycles; after chemotherapy patients will be assessed for surgery. The~     anticipated time on study treatment is 3-12 months, and the target sample size is <100~     individuals.~   "
227701|NCT00576888|"~     PURPOSE The purpose of this study is to learn more about multifocal~     lymphangioendotheliomatosis with thrombocytopenia (MLT). MLT is a rare vascular disorder~     characterized by multiple congenital skin and visceral lesions, profound thrombocytopenia,~     and gastrointestinal bleeding. The skin lesions may appear red, brown or blue, often~     misdiagnosed as hemangiomas. The gastrointestinal tract, liver, and lungs are the most common~     internal organs involved. The severe thrombocytopenia (low platelets) is believed to be the~     result of platelet trapping within the skin and visceral vascular lesions. Severe and chronic~     gastrointestinal bleeding is common during infancy and early childhood. Although a relatively~     newly described entity, MLT was likely previously reported as hemangiomas, blue rubber bleb~     nevus syndrome, diffuse hemangiomatosis, Kasabach-Merritt phenomenon, and hereditary~     hemorrhagic telangiectasia. The term cutaneovisceral angiomatosis with thrombocytopenia is~     also a term used for this same disease. This study is a longitudinal cohort study of MLT to~     collect detailed clinical data on the distribution of disease, disease severity, and~     complications. This data will be used to create diagnostic criteria and an evaluation~     protocol for infants with this disease~   "
227702|NCT00576875|"~     The proposed Silvio O. Conte Center for Neuroscience of Depression will focus on~     understanding the neurobiological mechanism of depression. A total of 5 projects are~     proposed. The center is focused on a single hypothesis. The first project examines~     localization of lesions, structural changes in critical regions subserving the circuit,~     alterations in the white matter tracts relevant to the circuit and changes in glutamate. The~     second project uses post mortem cell counting and cellular localization in serotonin~     receptors and assessment of the type of cell loss in the orbitofrontal cortex. The third~     project uses cognitive paradigms and functional MRI to probe the circuit and the role of~     brain lesions and serotonin on the functioning of this circuit. The fourth project uses~     transgenic and knockout mice to examine to role of norepinephrine and serotonin as it relates~     to the circuit. The final project is designed to assess in these transgenic mice using~     multielectrode array of single neuron recordings of the firing pattern of the circuit neurons~     in various states and tasks and the role of monoamines in modulating this circuit.~   "
227703|NCT00576862|"~     The purpose of this trial is to allow patients to continue on HOE 901 until launch and to~     gather additional long-term safety data.~   "
227704|NCT00576849|"~     A total balanced fluid replacement strategy is a promising concept for correcting~     hypovolemia. The effects of a balanced fluid management including a new balanced~     hydroxyethylstarch (HES) in elderly cardiac surgery patients will be studied.~   "
227705|NCT00576836|"~     One purpose of this study is to determine whether the amount of thymus tissue transplanted~     into DiGeorge anomaly infants has any effect on the immune outcome. Another purpose of this~     study is to determine whether parental parathyroid gland transplantation (in addition to~     thymus transplantation) can help both the immune and the calcium problems in DiGeorge infants~     with hypocalcemia. [Funding Source - FDA OOPD]~   "
227706|NCT00576823|"~     Primary objective was to determine efficacy of Alfuzosin in the treatment of children and~     adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to~     elevated detrusor Leak Point Pressure [LPP] of neuropathic etiology.~      Secondary objectives were:~        -  To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and~          adolescents,~        -  To investigate the number of Urinary Tract Infection (UTI) episodes,~        -  To investigate the pharmacokinetics of Alfuzosin (population kinetics).~   "
227707|NCT00576810|"~     The objective ot the study is to compare the efficacy and safety of 4 weeks treatment with~     sodium picosulphate drops 10mg to placebo in patients with functional constipation. In~     addition the effect of treatment on quality of life and general health status will be~     evaluated~   "
227723|NCT00576602|"~     This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera,~     versus no ESA therapy, in chronic kidney disease patients with anemia after kidney~     transplant, not currently treated with ESA. Patients will be randomized to receive~     a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks,~     switching to monthly treatment at week 16 or b)supportive treatment (eg. iron~     supplementation) for management of low hemoglobin concentrations. The anticipated time on~     study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
227708|NCT00576797|"~     The human vagina contains a large number of normal bacteria. These bacteria are important~     because provide protection against other bacteria that may cause disease. Several important~     diseases are linked to abnormal bacteria in the vagina. Women with abnormal bacteria in the~     vagina are more likely to be infected with human immunodeficiency virus, the virus that~     causes AIDS. Also women with unusual bacteria in their vagina are more likely to deliver a~     premature baby when they are pregnant. For these reasons, it is important to have a better~     understanding of the normal bacteria of the vagina.Some bacteria found in the vagina can not~     be grown in a laboratory. Our preliminary studies indicate a very wide variety of bacteria in~     the vagina. Also we have shown there are some differences between African American and~     Caucasian women. The goal of our study is to study the bacteria in the vagina of normal women~     using the latest technology. This technology involves study the bacterial DNA present in the~     normal microbes in the vagina~   "
227709|NCT00576784|"~     The goal of the study is to demonstrate whether a switch from insulin therapy to an oral~     therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control~     (increase in HbA1c by more than 0.5 %) within a 6 month observation period.~   "
227710|NCT00576771|"~     The investigators' aim is to study the effect of pressure support ventilation versus neurally~     adjusted assist (NAVA) and controlled by patient in mechanically ventilated ALI/ARDS~     subjects.~   "
227711|NCT00576758|"~     This study will investigate the efficacy of weekly intravenous obinutuzumab [GA101~     (RO5072759)] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma.~     Patients will be randomized to receive either GA101 or rituximab, given as four weekly~     infusions. At the conclusion of the initial trial patients may be eligible to continue~     therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the~     target sample size is 100-500 individuals.~   "
227712|NCT00576745|"~     Following closure of surgical incisions, wounds may develop redness, swelling, and drainage~     which may result in increased pain and infection. This study will test to hypothesis that~     using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness,~     swelling, and infections in a group of patients undergoing a mediastinotomy incision used for~     open heart surgical procedures.~   "
227713|NCT00576732|"~     The purpose of this study is to evaluate the effectiveness (change in level of irritability~     and related behaviors) and safety and tolerability of the administration of 2 different fixed~     dose levels of risperidone (an atypical antipsychotic drug) compared with placebo in children~     or adolescents who have autism, and to evaluate the safety and tolerability of the drug for~     additional 26 weeks after the initial 6-week study period.~   "
227714|NCT00576719|"~     This study will evaluate the effectiveness of intensive cognitive behavioral therapy in~     treating adolescents with panic disorder with agoraphobia.~   "
227715|NCT00576706|"~     To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of~     Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.~   "
227716|NCT00576693|"~     PRIMARY HYPOTHESIS:~      Compared with intensive medical therapy alone, intracranial angioplasty and stenting combined~     with intensive medical therapy will decrease the risk of the primary endpoint by 35% over a~     mean follow-up of two years in high-risk patients patients with 70% - 99% intracranial~     stenosis who had a transient ischemic attack (TIA) or stroke within 30 days prior to~     enrollment) with symptomatic stenosis of a major intracranial artery.~      SUMMARY:~      The best treatment for prevention of another stroke or TIA in patients with narrowing of one~     of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting~     medications to prevent blood clots from forming in the narrowed vessel. There are a variety~     of medicines used for this purpose. These medications are usually taken for the rest of a~     patient's life.~      However, a treatment that has been used successfully together with anti-clotting medications~     in patients with narrowing of the blood vessels of the heart is now being studied in the~     blood vessels of the brain. This treatment is called stenting.~      Recent research has also indicated a benefit in prevention of recurring stroke by Intensive~     Medical Therapy, which is defined as treating risk factors for stroke like high blood~     pressure, elevated LDL (low density lipids - the bad form of cholesterol) and diabetes. The~     purpose of this study is to compare the safety and effectiveness of either Intensive Medical~     Therapy PLUS Stenting or Intensive Medical Therapy ONLY in preventing stroke, heart attacks~     or death.~      The study will enroll patients over a 5 year period. Each participant will be involved in the~     study for a minimum of 1 year and a maximum of 3 years.~      Fifty different medical centers in the United States are part of this study. Both the~     Clinical Coordinating Center and the Statistical Coordinating Center for the entire study~     will be located at Emory University.~   "
227717|NCT00576680|"~     This research study will test the safety of RAD001 in combination with temozolomide.~   "
227718|NCT00576667|"~     The purpose of this study is to assess the effect of Rimonabant treatment on the histological~     features of Nonalcoholic Steatohepatitis (NASH).~   "
227719|NCT00576654|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with irinotecan hydrochloride in treating patients with cancer that has spread to other parts~     of the body or that cannot be removed by surgery. Irinotecan hydrochloride can kill cancer~     cells by damaging the deoxyribonucleic acid (DNA) that is needed for cancer cell survival and~     growth. Veliparib may block proteins that repair the damaged DNA and may help irinotecan~     hydrochloride to kill more tumor cells. Giving irinotecan hydrochloride together with~     veliparib may kill more cancer cells.~   "
227720|NCT00576641|"~     The purpose of the Dendritic Cell Immunotherapy study for patients with glioblastoma and/or~     brainstem glioma is to determine whether in patients with malignant brain tumors, dendritic~     cells injected peripherally can reactivate the immune system against the brain tumor.~   "
227721|NCT00576628|"~     This single arm study will assess the efficacy, safety and tolerability of subcutaneous~     C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with~     chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible~     patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight~     (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study~     treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
227722|NCT00576615|"~     The purpose of this study is to relate changes in the blood flow in your brain which are~     measured using magnetic resonance imaging (MRI) to temporary changes in your memory and level~     of sleepiness while receiving the drug propofol, which is commonly used to induce relaxation~     or sleepiness for minor surgical procedures. This study will help provide us information~     which will be useful in understanding which parts of the brain are influenced by these drugs~     to affect memory and sleepiness.~   "
227724|NCT00576589|"~     The study is designed to assess whether repeated dosing with CE-326,597 will cause patients~     with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become~     symptomatic. In addition, the study will characterize the pharmacokinetics of CE-326,597.~   "
227726|NCT00576563|"~     To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour~     characteristics determined in the plasma of patients with rectal cancer during and after~     radiotherapy or combined radiotherapy and chemotherapy.~      The changes of the FDG uptake of the primary tumour and the evolution of key tumour~     characteristics during radiotherapy alone or in combination with chemotherapy will be~     predictive for the pathological tumour response.~      Study hypothesis The changes of the FDG uptake of the primary tumour and the evolution of key~     tumour characteristics during radiotherapy alone or in combination with chemotherapy will be~     predictive for the pathological tumour response.~   "
227727|NCT00576550|"~     The purpose of this study is to investigate whether a moisturizing cream can prevent hand~     eczema.Patients with previous hand eczema will be studied. In the second part of the study,~     it will be explored if a treatment regimen of a topical corticosteroid once daily is not~     inferior to treatment twice daily.~   "
227728|NCT00576537|"~     This research is being determine whether vaccinations with your own immune cells called ~     dendritic cells  can activate your immune system to fight your brain tumor.~   "
227729|NCT00576524|"~     The purpose of this study is to evaluate the application of the impedance threshold device~     during hemodialysis in children to optimize fluid removal, reduce the incidence of~     complications (such as cramps,vomiting and hypotension), and device tolerance.~   "
227730|NCT00576511|"~     The purpose of this study is to determine whether prucalopride is safe and effective in~     patients with severe chronic constipation.~   "
227731|NCT00576498|"~     Primary Aim: In patients with endoscopically suspected BE, compared to standard endoscopy,~     novel techniques (NBI and AFI) with target biopsies will~        -  Detect more patients with intestinal metaplasia~        -  Detect more areas of high grade dysplasia~        -  Require fewer biopsies and a shorter time for procedure completion~      Secondary Aim:~        -  Compare the yield of high-grade dysplasia(HGD)using NBI/AFI versus standard endoscopy~          with biopsy.~        -  Compare the number of biopsies and procedure times for NBI/AFI versus standard endoscopy~          with biopsy.~        -  Compare the inter-observer variability in classifying different mucosal and vascular~          patterns observed by NBI/AFI using kappa statistics.~   "
227732|NCT00576485|"~     Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified~     anterior aspheric surface results in reduced spherical aberration and improved contrast~     sensitivity after cataract surgery.~      Design: Prospective, comparative, interventional case series.~      Methods: In an intraindividual randomized prospective study of 25 patients with bilateral~     cataract, an IOL with a modified anterior surface (Tecnis Z9001, AMO- Group 1) was compared~     with biconvex lens with spherical surfaces (ClariFlex®, AMO- Group 2). Ocular aberrations for~     a 5.0 mm pupil and 6.0 mm pupil were measured with Hartmann-Shack aberrometer. Quality of~     vision was measured by visual acuity and contrast sensitivity under mesopic and photopic~     conditions. All patients were followed for 3 months.~   "
227733|NCT00576472|"~     Children surviving some types of cancer have a higher risk of developing learning problems~     after cancer treatment than do children who have not had cancer or its treatment. Cancer~     treatment may cause problems with learning, attention, and memory. The purpose of this study~     is to identify brain changes that may underlie learning problems in cancer survivors and~     investigate whether methylphenidate (a stimulant medication) may reduce these problems.~      Subjects who have had treatment for acute lymphoblastic leukemia (ALL) or a brain tumor will~     be asked to take part in this research study. Siblings of some subjects will also be asked to~     take part, so that their results can be compared with those of children who have had cancer~     treatment. We hypothesize that children receiving more aggressive therapy will have lower~     white matter brain volumes and these volumes will be significantly lower than age-matched~     siblings. We also hypothesize that children who take methylphenidate will show improvements~     on teacher and parent report measures of attention and social skills.~   "
227734|NCT00576459|"~     This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the~     safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to~     laser photocoagulation in the treatment of patients with diabetic macular edema.~   "
227735|NCT00576446|"~     Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis~     carries with it a median survival of approximately 12 months, with 90 - 95% of patients~     surviving less than 2 years. The current standard treatment of surgical resection followed by~     radiation therapy and chemotherapy has not substantially prolonged survival and even the few~     treatment options shown to exhibit small increases in survival primarily benefit certain~     (i.e., young) patient subpopulations.~      Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body~     to recognize the tumor cells as foreign and produce its own response to fight off recurring~     tumor cells. A promising means of causing an immune response so the body can create this~     immunity is through the use of dendritic cell (DC) vaccines.~      Dendritic cells are a small group of cells contained in everyone's white blood cell~     population. These cells are responsible for letting the immune system know that something~     foreign, like bacteria, or a tumor, is in the body. Dendritic cells help the body ward off~     disease by alerting the immune system.~      gliadel is an FDA - approved drug - a wafer containing a concentrated amount of a~     chemotherapy agent. These wafers are placed into the brain cavity after the tumor is resected~     (removed) and deliver a steady amount of immediate chemotherapy medicine to the surrounding~     brain tissue. Also, since Gliadel is a local chemotherapy, it will prevent the detrimental~     suppression (weakening) of the immune system shown with systemic (throughout the body)~     chemotherapy.~      In prior Phase l and phase ll studies, patients who received chemotherapy following Dendritic~     cells demonstrated longer progression free and overall survival than the patients who~     received Dendritic cells or chemotherapy alone.~      The purpose of this study is to determine whether after standard therapy of tumor resection~     surgery, along with placement of Gliadel wafers at time of surgery followed by dendritic cell~     vaccines will not only generate (start) an immune response, but will provide longer~     progression free survival.~      Patients who were screened and not enrolled in this clinical trial due to screen failure will~     be notified of the reason for screen failure. Pre HIV counseling and appropriate referral~     resources will be provided. If the screen failure is due to the positive HIV test,~     appropriate post HIV counseling will be provided and appropriate referrals will be made. The~     charts of the patients with screen failures will be destroyed.The patients charts who will be~     enrolled in the study kept in the locked cabinet in the research office. patients will be~     assigned a unique identifying code known only to the research team. Data will be captured by~     various source documents, or, as necessary, abstracted from hospital medical records by an~     experienced registered nurse. The electronic data for viral testing will be accessible to~     research personnel only.~   "
227736|NCT00576433|"~     This single arm study will evaluate the safety and efficacy of MabThera in patients with~     active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an~     inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg~     i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a~     clinically relevant response to the first course of treatment may be eligible to receive one~     re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study~     treatment is 3-12 months, and the target sample size is 100 individuals.~   "
227738|NCT00576407|"~     The study purpose is to determine whether thymus transplantation without immunosuppression is~     effective in treating typical complete DiGeorge syndrome.~   "
227740|NCT00576381|"~     The purpose of this study is to determine what happens to dexmedetomidine in the body after~     it has been given to a newborn after heart surgery. We want to learn how long the drug stays~     in the body, how the drug is metabolized by the body, and how well the medicine works at a~     particular dose or amount.~   "
227741|NCT00576368|"~     The objective of this survey on this registered product is to confirm the efficacy, and~     safety profile of Lantus in every day medical practice. This program will also help to obtain~     information about the use of the insulin titration regimen and handling of the Lantus insulin~     analogue.~   "
227742|NCT00576355|"~     This study will evaluate the effectiveness of interpersonal and social rhythm therapy in~     treating adolescents with a bipolar spectrum disorder~   "
227743|NCT00576342|"~     In this randomized crossover study, patients will receive a single drop of two test articles~     and assess comfort.~   "
227744|NCT00576329|"~     To determine whether use of topical 0.4% ketorolac has any effect on pupil size during~     vitreoretinal surgery.~   "
227745|NCT00576316|"~     The purpose of the study is to evaluate the satisfaction level of patients using the~     Symbicort SMART approach for their asthma management.~   "
227746|NCT00576303|"~     This single arm study will assess the efficacy, safety and tolerability of monthly~     intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with~     chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive~     monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360~     micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the~     week preceding study start. The anticipated time on study treatment is 3-12 months, and the~     target sample size is 100-500 individuals.~   "
227747|NCT00576277|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     AV411 after single and multiple doses in patients with chronic neuropathic pain due to~     diabetes.~   "
227748|NCT00576264|"~     The purpose of this research study is to determine the genotype (genetic composition) and~     phenotype (physical appearance) of cells derived from the abdominal cavity to determine~     whether stem cells are present.~   "
227749|NCT00576251|"~     The purpose of this study is to describe the differences in efficacy between TOBRADEX~     Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the~     treatment of ocular inflammation and infection associated with blepharaconjunctivitis~   "
227750|NCT00576238|"~     Topical steroid creams as well as moisturizing creams are important parts of the treatment~     strategy of atopic eczema. This study aims to investigate the tolerance of a new strong~     steroid cream in comparison to an already marketed reference cream with equal amount of~     active but with different cream vehicle. The second part of the study will investigate the~     possible preventative property of a moisturizing cream on skin that has been previously~     cleared from eczema.~   "
227751|NCT00576225|"~     This study is designed to test whether CT-2103/carboplatin provides improved overall survival~     compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.~   "
227752|NCT00576212|"~     This study focuses on women undergoing termination of pregnancy for fetal anomalies (TOPFA).~     Psychological consequences of such terminations may be even greater than those associated~     with spontaneous losses of pregnancy because of shame and guilt which can result in social~     isolation. Currently, there is little support for women after they have left hospital. In~     this study, 50 TOPFA women will be randomly assigned to an intervention group and 50 to a~     control group. By completing four questionnaires at the time of induction of labour, total~     sample will be assessed for depression, stress and hardiness; they will be reassessed at 3,~     6, and 12 months. Total sample will be interviewed by phone at 6 and 12 months. We hope to~     determine whether a telephone-based intervention (a biweekly supportive call) can decrease~     the emotional distress experienced by women undergoing termination of pregnancy.~   "
227753|NCT00576199|"~     This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab)~     treatment combined with transarterial chemoembolisation (TACE) in patients with localized~     unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4~     sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously~     was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE~     sessions until disease progression.~   "
227754|NCT00576186|"~     This research study is designed to evaluate the accuracy of the techniques that are used to~     analyze heart function. The main purpose of this study is to analyze and compare three~     different methods of assessment of regional and overall heart function.~   "
227755|NCT00576173|"~     The purpose of this study is to evaluate the analgesic effectiveness and safety of 37.5mg~     Tramadol hydrochloride/325mg Acetaminophen in the treatment of breakthrough pain in cancer~     patients.~   "
227756|NCT00576160|"~     Many post Acute Coronary Syndrome(ACS) patients do not take their medications (including~     aspirin) as prescribed, leading to an increase in mortality. Patients enrolled in this study~     will be enrolled into one of two groups. Patients in the first group will have their~     medication adherence measured, but will receive all other care as usual. Patients in the~     second group will also have their medication adherence measured, but they will receive~     telephone-delivered problem solving therapy (PST) in addition to their usual care. The two~     groups will be combined to determine the Minimally Effective Dose (MED) and the Maximally~     Tolerated Dose (MTD) for adherence to aspirin. The medication adherence of the PST group will~     improve by 20% (<55% to >75%).~   "
227757|NCT00576147|"~     The purposes of this study are:~        1. To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS)~          measurements for identifying intracranial hematomas due to trauma.~        2. To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements~          with different operators and at different centers~   "
227758|NCT00576134|"~     Supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in~     order to allow tracheotomy closing (when applicable) and / or to allow restoration of god~     swallowing capacity. The secondary objective is to study the concept of a special valves~     system for the development of an artificial larynx~   "
227759|NCT00576121|"~     This study is designed to look at the measurement and prediction of changes in the heart~     following a heart attack.~   "
227760|NCT00576108|"~     This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo~     in the treatment of postherpetic neuralgia.~   "
227762|NCT00576082|"~     The aim of this study is to identify the species of Borrelia involved in the dermatologic~     manifestations of Lyme borreliosis in France. Indeed, in Europe, as opposed to North America,~     many bacterial species are involved in Lyme borreliosis. Yet, very few is known about the~     prevalence and distribution of different bacteriological species that account for the disease~     in France. Thus, this a nation-wide study in which all French dermatologists are invited to~     participate. Every adult patient presenting with one of the cutaneous manifestation of Lyme~     borreliosis: erythema migrans, lymphocytoma or acrodermatitis chronica atrophicans can be~     included in the study. If the patient agrees participating, after information and written~     consent, a cutaneous biopsy will be performed in order to isolate Borrelia by means of~     culture and PCR. An estimated 400 biopsies should be performed within 2 years.~   "
227763|NCT00576069|"~     The purpose of this study is to evaluate the site and mechanisms responsible for expiratory~     airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to~     severe persistent expiratory airflow obstruction. Treatment will include inhaled~     corticosteroids and long acting beta2agonists and long acting muscarinic antagonists. We are~     interested in determining whether the large and/or small airways are the predominant site of~     airflow limitation. We are also interested in determining whether intrinsic small airways~     obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow~     limitation and to what extent may be attributed to loss of lung elastic recoil vs decreased~     airway conductance in peripheral airways. We are also interested to evaluate the role of~     varying doses of inhaled corticosteroids to suppress large and small airway inflammation~     using exhaled nitric oxide as surrogate markers of inflammation. For comparison purposes,~     spirometry and measurements of exhaled nitric oxide will also be obtained if possible during~     a naturally occurring exacerbation of asthma. High resolution thin section CT of the lung~     will also be obtained. Analysis will evaluate integrity of the lung parenchyma as to absence~     and or presence of emphysema and extent of emphysema using voxel quantification. We will also~     investigate optical coherence tomography to detect clinically unsuspected emphysema. We will~     also obtain autopsy material when available in asthmatics who expire. Will also measure serum~     periostin as a marker of inflammation by collaborating with Genetech in San Francisco.~   "
227764|NCT00576056|"~     The purpose of this study is to determine if TACE plus Sorafenib will improve outcome in~     patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery.~   "
227765|NCT00576043|"~     Trainees (Residents in internal medicine), naive to real patient endoscopy, will be~     randomized to receive either 3 weeks/2 hours per day of structured training for a total of 20~     hours on the virtual endoscopy simulator GI-Mentor or no training before starting on-patient~     endoscopy in the University of Vienna Medical School Endoscopy Unit. Patients satisfaction~     and pain, technical accuracy and number of found/missed pathologies as well as average time~     for successful endoscopy will be recorded. After one month or 50 supervised, self performed~     endoscopies, trainees will be evaluated again with the above mentioned criteria during ten~     consecutive investigations.~   "
227766|NCT00576030|"~     More than 80% of the population in the USA consume coffee each day. However there not many~     studies on change of heart rate variability and placebo effects after consumption of coffee.~      In our study we aim to test the following hypotheses:~        1. Habitual caffeinated espresso coffee drinkers show an increase in blood pressure, heart~          rate variability and parasympathetic activity (high frequency band) of the heart.~        2. Non-habitual caffeinated espresso coffee drinkers show an increase of blood pressure.~          The heart rate variability and the parasympathetic activity of the heart will decrease.~        3. Caffeinated or decaffeinated espresso induces comparable changes in habitual or~          non-habitual coffee drinkers.~   "
227767|NCT00576017|"~     To show, using the analgesic WHO scale, that fentanyl-TTS may be directly used for treating~     moderate to severe cancer pain in patients treated with NSAIDs, acetaminophen, or metamizole~     (first step drugs) avoiding the second step, and may be at least as effective and safe as~     currently used second step drugs, minor opioids.~   "
227768|NCT00576004|"~     To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in~     patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ~     prolapse (POP) repair~   "
227769|NCT00575991|"~     The prevalence of overweight children has increased dramatically over the last decade, and~     many overweight children will remain overweight as adults. Conjugated linoleic acid (CLA), a~     naturally occurring dietary fatty acid, has shown promising results in reducing body fat~     among adults, and we propose to test the efficacy of CLA supplementation on body fat~     accretion in 6 to 10 year old children who are overweight or at risk of overweight.~   "
227770|NCT00575978|"~     This study will be conducted as a phase I/II clinical trial. In addition to determining the~     maximum tolerated dose (MTD) of hydralazine, the phase I trial will be performed to identify~     unexpected toxicities that may occur when hydralazine is used in conjunction with neoadjuvant~     chemotherapy in normotensive women with breast cancer. Once the phase I trial is successfully~     completed, the phase II trial to evaluate the efficacy of hydralazine in producing a~     demethylation effect will begin.~   "
227771|NCT00575965|"~     This research study seeks to find new ways to treat people with Waldenstrom's~     Macroglobulinemia (WM). The study is for participants with slow growing WM who otherwise~     might not need therapy for at least 3-6 months. Simvastatin is a drug approved by the FDA for~     lowering cholesterol. In test tube studies the study drug appears to have direct anti-cancer~     effect against WM tumor cells and mast cells.~   "
227772|NCT00575952|"~     This phase I trial studies the side effects and best dose of intraperitoneal paclitaxel when~     given together with doxorubicin hydrochloride and cisplatin in treating patients with stage~     III-IV endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, doxorubicin~     hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) and giving them in different ways may kill more tumor cells.~   "
227783|NCT00575809|"~     Our study intends to evaluate prospectively the incidence and severity of oral mucositis in~     patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as~     well as to evaluate the potential influence of nutritional-, physical-, and~     transplant-related factors associated with the development of this complication and its grade~     of involvement.~   "
230346|NCT00541476|"~     The purpose of this study is to obtain more data about efficacy and safety of the study drug~     Lyrica.~   "
227773|NCT00575939|"~     It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin~     resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis.~     Several cohorts have shown an increased risk of heart disease in people with HIV. The effect~     of HIV treatment versus HIV itself on the incidence of heart disease is unclear. In this~     study the investigators will assess the effect on carotid IMT of the initiation of~     antiretroviral combinations that are known to have a minimal effect on lipids and insulin~     resistance. We will also assess the changes in several inflammation and cardiovascular~     markers,as well as endothelial activation markers,and how these changes relate to~     therapy-induced changes in immunologic, virologic and metabolic markers.~   "
227774|NCT00575926|"~     Ganoderma lucidum (Lingzhi) is a Traditional Chinese Medicine which is widely used as a means~     to 'strengthen immunity' among patients with cancers. However, there is no published~     randomized controlled clinical trial on its efficacy and safety despite the many in vitro~     studies on its anti-viral, anti-oxidative, anti-tumour, radioprotective, hepato-protective~     and immunomodulatory effects. This study was a randomized, double-blind, placebo-controlled,~     parallel clinical trial that investigated the benefits and safety of Ganoderma lucidum~     (Lingzhi) in treating children with cancers. Patients were randomized to receive identical~     capsules of either Lingzhi or placebo for six months. The primary outcome was the general~     Paediatric Quality of Life score. Secondary outcomes included immune functions,~     infection-related morbidities, complete blood counts and serum biochemistry, and overall and~     event-free survival.~   "
227775|NCT00575913|"~     To assess, under daily practice conditions, the safety profile and the efficacy of a new~     formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary~     tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).~   "
227776|NCT00575900|"~     A three arms open,randomized interventional study in order to compare the impact of low~     carbohydrate diets with different protein and fat ratios versus a standard balanced diet on~     BMI and metabolic parameters in obese adolescents.~      55 obese adolescents (12-18y, BMI > 95th percentile) were randomly allocated to one of three~     12-weeks diet regimens: low-carbohydrate low-fat, low-carbohydrate high-fat or balanced~     low-fat diet, followed by 9-months follow-up. Weight, Height, waist circumference, lipid~     profile, glucose, insulin, liver enzymes, renal functions, C-reactive protein, leptin,~     ghrelin and resting energy expenditure were measured in the morning after over-night fast at~     baseline, during the 12-weeks of intervention and after 9-months of follow-up.~   "
227777|NCT00575887|"~     The purpose of this study is to evaluate the efficacy of temozolomide on a protracted~     schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive~     high grade glioma.~   "
227778|NCT00575874|"~     The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to~     pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of~     treatment in patients with type 2 diabetes.~   "
227779|NCT00575861|"~     Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair~     250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased~     total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven~     pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor~     by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.~   "
227780|NCT00575848|"~     The goal of this project is to understand whether glycine is helpful for improving some~     symptoms of schizophrenia such as low motivation, loss of interest, and social isolation. In~     addition, the investigators want to find out if glycine improves memory.~      This project involves a three-and-a-half month trial of glycine or placebo. A placebo looks~     exactly like the study drug, but it contains no active drug. Glycine is a naturally occurring~     substance that is a part of some of the proteins in your body. Glycine has not been approved~     by the FDA (Food and Drug Administration) for the treatment of schizophrenia. However, the~     FDA allows it to be used in research studies.~      Related Study at McLean Hospital: If you would like to participate in this study of glycine~     versus placebo at the Freedom Trail Clinic, the investigators will ask you if you would also~     like to participate in a related study at McLean Hospital. The study at McLean Hospital will~     look at the effects of glycine and placebo on levels of glycine in the brain. The study will~     use magnetic resonance spectroscopy to measure brain glycine levels. The magnetic resonance~     (MR) scanner looks like a large cylinder with a tube running down the center. You will be~     asked to lie down on your back on a foam-padded table and place your head into a special~     holder. The table will slide you inside the hole of the scanner. Soft foam rubber sponges~     may be placed on both sides of your head for comfort and to help keep your head from moving.~     Because the scanner contains a strong magnet, you will be asked to remove all metal objects~     from your person including, but not limited to: watches, rings, necklaces, bracelets,~     earrings and other body piercings, belts, loose change, wallet (with credit cards), items of~     clothing containing magnetic materials (for example, underwire bras, certain types of~     zippers), and shoes. These items will be secured in a safe place until your scan is~     completed. You will be able to remain in your street clothes. The investigators will ask you~     if study staff from McLean Hospital can contact you to tell you more about the study. You may~     refuse to be contacted by McLean Hospital. However, if you do not participate in the study at~     McLean, you are not eligible for the study here at the Freedom Trail Clinic.~   "
227781|NCT00575835|"~     The aim of this study is to compare oral vitamin D supplementation administered in two~     different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year~     (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily~     supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH~     vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of~     25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in~     vitamin D concentrations in these treatments. 3) Find out safety of these treatments~   "
227782|NCT00575822|"~     The aim of this study was to determine the effectiveness of endoscopic full-thickness~     plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in~     comparison to a sham procedure.~      Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were~     entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight~     patients were randomly assigned to undergo endoscopic full-thickness restructuring of the~     gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group~     assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50%~     improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal~     acid exposure.~      Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds~     were considered responsive to their assigned procedure. Patients who failed to reach this~     level of improvement at 3-months were considered non-responders. Analysis of these~     dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing~     the proportion of responders between the active and sham groups. Intent-to-treat analysis was~     also performed. The null hypothesis was that the proportion of responders was the same in~     both the active and sham groups. Testing was done at the 5% level of significance~     (alpha=0.05).~   "
227784|NCT00575796|"~     The overall objective of this study is to determine the efficacy of weekly Vinblastine in~     chemotherapy naïve patients with progressive or incompletely resected paediatric low grade~     glioma, to generate estimates of the response rate, progression-free survival, toxicity and~     quality of daily living among the population treated and determine biologic factors which~     will enable us to predict tumour behaviour.~   "
227785|NCT00575783|"~     The research study is designed to examine the impact of low blood sugar on brain function in~     individuals with Type 1 Diabetes who have frequent and severe hypoglycemia (low blood sugar)~     compared to those who do not.~   "
227786|NCT00575757|"~     Because NASH is now recognized as a significant cause of cirrhosis with associated morbidity~     and mortality, its recognition as a long term complication of HAART is important to the~     management of those living with HIV.~   "
227787|NCT00575744|"~     We continue to collect information in support of the hypothesis that the histology of the~     first draining lymph node (sentinel node) accurately predicts the histology of the rest of~     the axillary lymph nodes.~   "
227788|NCT00575731|"~     Although studies demonstrate that people who consistently keep detailed food records are more~     likely to maintain their weight, few people continue to keep records given the vigilant~     attention needed. This study will test the efficacy of an alternative approach to record~     keeping that may be easier for people to sustain and lead to better long-term weight~     management. We propose that obese adults who attempt to keep their weight within a clearly~     defined and personalized 'range', e.g., a 5-lb range between 200-205 pounds, will be more~     likely to continue weighing themselves and remain weight stable because they have learned to~     self-regulate, i.e., accurately monitor changes in their weight, alert themselves when~     they've gained too much weight, and 'finetune' their eating and physical activity in~     response, but with the minimum effort and attention necessary. The primary aim for this~     randomized trial will examine whether participants in an 8-week 'Fine-Tuning' program are~     more likely to weigh themselves over the 6-month study than participants in an 8-week~     traditional 'Record-Keeping' program.~   "
227789|NCT00575718|"~     The purpose of this study is to see if we can find ways to improve the treatment of tobacco~     dependence in patients who have cancer or may have cancer. We will compare two ways to help~     people quit tobacco use before surgery and to stay quit after surgery. One way is a scheduled~     reduced smoking program followed by use of the nicotine patch. In this program, the tobacco~     user will gradually cut down on their tobacco use until they quit. Once they quit, they will~     be offered the nicotine patch. We will compare this approach to our current program of~     counseling and use of nicotine patch. What we learn from this study may help us to develop~     new ways to help tobacco users and improve our current smoking cessation program.~   "
227790|NCT00575692|"~     The aim of the present study is to identify changes in the cardiovascular system in patients~     with pulmonary hypertension (PH) by magnetic resonance imaging (MRI). MRI is accepted as~     golden standard method for the evaluation of left and right ventricular morphology and~     function.~      All patients who showed elevated pulmonary pressure in the right heart catheter investigation~     are assigned to MRI. Parameters derived from MRI are included in the clinical and therapeutic~     decisions. Well established as well as new MRI parameters are evaluated and compared to the~     results of right heart catheter. Further age-matched controls without known cardiac or~     pulmonary disease are investigated by native MRI.~   "
227791|NCT00575679|"~     The purpose of this study is to determine whether brief motivational interviews reduce the~     likelihood of driving under the influence of alcohol (DUI).~   "
227792|NCT00575666|"~     This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal~     insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia~     subjects to examine insulin's effect on psychopathology and cognition. In addition, the study~     will examine insulin's effects on weight, food intake, resting energy expenditure, and body~     composition.~   "
227793|NCT00575653|"~     We are conducting a large, record-based study to assess the risk of Guillain-Barré Syndrome~     (GBS), a serious demyelinating disease, following immunization with the tetravalent~     meningococcal conjugate vaccine (Menactra) that is currently recommended for all adolescents.~     The study was requested by CDC and FDA because of an unexpected number of case reports to the~     CDC's Vaccine Adverse Event Reporting System (VAERS).~      The study protocol was designed by the investigators, with input from FDA, CDC, and the~     vaccine's manufacturer, Sanofi-Pasteur. An external advisory board that includes CDC~     representation, provides input regarding important decisions. The manufacturer is not~     participating in the conduct of the study and has no control over the analysis or~     dissemination of results.~      The study is derived from five large US health plans with a total membership of approximately~     50 million over the study time period. America's Health Insurance Plans (AHIP) serves as~     liaison between the health plans and the Coordinating Center at the Department of Ambulatory~     Care and Prevention of Harvard Medical School and Harvard Pilgrim Health Care, and is the~     contracting organization with the health plans.~   "
227794|NCT00575640|"~     Clinically feasible dose of Hydralazine for ~ 3 months, by virtue of its demethylating~     effect, will:~        1. Result in re-expression of epigenetically silenced TSGs in rectal cancer specimens.~        2. Decrease the global methylation in primary cancer cells compared to pre-treatment~   "
227795|NCT00575627|"~     Patients with chronic hepatitis C with persistently normal alanine aminotransferase (ALT)~     levels have been generally excluded from treatment, because the strong conviction that normal~     ALT would be synonymous of absence of liver damage. However, recent studies have demonstrated~     marked liver fibrosis, including cirrhosis, in patients with HCV and persistently normal ALT~     levels. Up to now, just a sigle randomized, controlled, multicenter study was lead to~     evaluate the efficacy and safety of combined therapy in patients with chronic hepatitis C and~     persistently normal serum ALT levels. Aim of our study is evaluate the efficacy of treatment~     and the outcome of treated patients compared with a control group of untreated patients.~   "
227796|NCT00575614|"~     The purpose of this study is to determine whether prucalopride is safe and effective in the~     treatment of chronic idiopathic constipation.~      Hypothesis:~      Prucalopride given at a dose of 1 mg o.d. for 4 weeks to female patients with chronic~     constipation shows a favourable effect on most of the efficacy parameters assessed in this~     trial. This dosage can be considered safe and generally well-tolerated.~   "
227797|NCT00575601|"~     The purpose of this study is to determine whether simvastatin is effective in the improvement~     of IVF-ICSI outcome in Pcos patients.~   "
227798|NCT00575588|"~     Saxagliptin is a new investigational medication being developed for treatment of type 2~     diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in~     addition to metformin and compare to sulphonylurea in addition with metformin.~   "
227799|NCT00575575|"~     The purposes of this research are:~        -  to understand the status of suicidal ideation, suicidal behavior, and depression in~          Harbin University students; and~        -  to analyse the infect factors of suicidal ideation and suicidal behavior.~      With cognitive behavior interventions on students with suicidal ideation, suicidal behavior,~     and middle or high degree of depression, the researchers can provide a scientific and~     effective intervention to the students.~      Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial.~      Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Department of Psychiatry,~     University of Pennsylvania, Philadelphia 19104, USA. gregbrow@mail.med.upenn.edu JAMA. 2005~     Aug 3;294(5):563-70.~   "
227800|NCT00575562|"~     The primary objective of this study is to assess the safety and tolerability of KRN330 in~     patients with relapsed or refractory advanced or metastatic colorectal cancer.~   "
227801|NCT00575549|"~     The purpose of this study is to prospectively analyze and compare conventional stress~     echocardiograms and real-time myocardial contrast stress echocardiograms; and to determine~     the effect of contrast agents used during real-time myocardial contrast stress~     echocardiograms on serum troponin I levels.~   "
227802|NCT00575536|"~     The purpose of this study is to determine the safe and effective levels of optical~     stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery.~   "
227803|NCT00575523|"~     Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the~     treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe~     complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia~     and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied~     by clinical complications such as unconsciousness, respiratory arrest or seizure like~     symptoms. Study purpose is to evaluate whether the use of i.v. Atropine before starting~     ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized,~     placebo controlled, double blinded study. Atropine or saline solution will be administered~     intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A~     6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal~     possibly occurring dysrhythmias.~   "
227804|NCT00575510|"~     This project will examine whether a theory-based telephone intervention delivered by a nurse~     at the time women are informed of an abnormal Pap test result will increase adherence to~     follow-up recommendations.~   "
227805|NCT00575497|"~     The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night~     time) hemodialysis six days a week, every other day and every other night hemodialysis to~     traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis~     treatment time and/or frequency will improve outcomes.~   "
227806|NCT00575484|"~     At present the standard management of fluid overload in patients with congestive heart~     failure (CHF) involves limiting the intake of salt and water while administering high dose~     diuretics, often at the cost of deteriorating kidney function. However, another group of~     researchers has previously shown that intravenously infusing small volumes of concentrated~     saline during diuretic dosing and liberalizing dietary salt intake while continuing to limit~     water consumption resulted in improved fluid removal in CHF patients. Furthermore, less~     deterioration in kidney function, shorter hospitalizations, reduced readmission rates, and~     even reduced mortality were observed. The present study will examine this novel therapy in a~     population of 60 patients with underlying severe CHF and kidney dysfunction hospitalized for~     the management of fluid overload. Half of these patients will receive investigational~     treatment with concentrated salt infusions and liberalized salt consumption during diuretic~     therapy. All patients will otherwise receive the standard therapies for heart failure,~     including restrictions on water consumption. This study will attempt to verify the~     improvements in clinical endpoints previously described and define the mechanisms of enhanced~     fluid removal.~   "
227807|NCT00575471|"~     The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the~     change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.~   "
227808|NCT00575458|"~     This study is comparing two different kinds of splints for patients who have had a surgical~     contracture release of dupuytren's disease. It compares a static splint and a dynamic splint.~   "
227809|NCT00575445|"~     The purpose of this study is to determine if exhaled nitric oxide (eNO) levels will be~     increased in pediatric patients with uncontrolled asthma as determined by the Asthma Control~     Test (ACT). During the study the investigators will also examine if the combination of eNO~     and ACT will better predict asthma control that either tool alone when compared to a medical~     provider's assessment of the patient's asthma control.~   "
227810|NCT00575432|"~     Multimodal functional magnetic resonance (MR) methods, including MR diffusion,~     Blood-Oxygenation Level Dependent (BOLD) imaging and MR spectroscopy may provide~     complementary information about the functional status of a kidney. The researchers~     hypothesize that these non-invasive methods correlate with histology as gold standard and~     compete favorably with conventional in part invasive evaluation methods, and thus provide~     specific and early detection of kidney diseases of various etiologies, drug toxicity, or~     renal allograft dysfunction.~   "
227811|NCT00575419|"~     This will be a randomized prospective dose escalation clinical study of N-acetylcysteine~     (NAC) in patients with stage 3 or worse renal failure (Glomerular Filtration Rate 30-60~     ml/min calculated with the Modification of Diet in Renal Disease formula), undergoing a~     procedure or imaging that requires the administration of contrast media at Oregon Health &~     Science University or the Portland Veterans Hospital. Subjects will receive NAC 60 minutes~     prior to the procedure or imaging requiring contrast media. Toxicity will be graded according~     to NCI Common Toxicity Criteria (CTC) version 3.0. An adult Phase 1 dose escalation study of~     NAC administered intravenously (IV) and intra-arterially (IA) will be performed. An isotonic~     nonionic contrast agent will be used in all cases. Contrast Induced Nephropathy (CIN) is~     defined as an increase in serum creatinine concentration of 25% or more from the subjects~     baseline value within a 72-hour period after the administration of contrast media. Serum~     creatinine concentration will be measured at admission, every day during in-patient~     hospitalization, and at hospital discharge.~   "
227812|NCT00575406|"~     Diffuse large B-cell lymphoma is the most prevalent subgroup within malignant lymphoma.~     Clinical benefit has been shown for the treatment with cyclophosphamide, doxorubicin,~     vincristin and prednisolone (CHOP regimen); this could be further improved recently by the~     addition of rituximab (R-CHOP), a monoclonal antibody.~      Improved response and overall survival rates make it necessary to evaluate late toxicities of~     the therapy regimens. Cardiotoxicity is a known risk factor of specific chemotherapies, with~     7% patients being affected if doxorubicin cumulative doses are under 550mg/sqm. Retrospective~     data analyses indicate that this incidence of cardiotoxicity may be higher under combination~     chemotherapy. Liposomal doxorubicin has been shown to have lower cardiotoxic effects and at~     the same time equivalent or higher efficacy compared to conventional doxorubicin.~      The aim of this study is to evaluate alternative regimens for the treatment of diffuse large~     B-cell lymphoma, substituting liposomal doxorubicin (R-COMP) for conventional doxorubicin~     (R-CHOP).~   "
227813|NCT00575393|"~     RATIONALE: Gold sodium thiomalate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of gold sodium~     thiomalate in treating patients with advanced non-small cell lung cancer.~   "
227814|NCT00575380|"~     The purpose of this study is to evaluate the drug concentrations in the conjunctiva and~     aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract~     surgery~   "
227815|NCT00575367|"~     The purpose of this study is to evaluate the drug concentrations of AzaSite compared to~     Vigamox in tears of healthy volunteers~   "
227816|NCT00575354|"~     Generally, benign breast tumors are excised under the local anesthesia. But such action was~     so invasive that every patient would experience the physiological and psychological stimuli~     unavoidably. Sevoflurane was advised as a better inhalational anesthesic for its easy~     come,easy go property during short-lasting operations than isoflurane. We purposed that~     sevoflurane would be a superior anesthesic for benign breast tumor excision than isoflurane~     with relative less alteration in hemodynamics, less postoperative side effects and~     easily-control the depth of anesthesia.~   "
227817|NCT00575341|"~     30 adolescent girls and young women between 13 and 26 years with central adrenal~     insufficiency and a grand shortage of DHEA are recruit. The clinical trial is double-blind to~     show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances~     well being and mood of the patients. It should also normalize the serum content of DHEA,~     aldosterone and testosterone.~   "
227818|NCT00575328|"~     The purpose of this research study is to find out whether Maca Root is effective for treating~     sexual dysfunction in females that is caused by the treatment for bipolar disorder. An~     additional aim of the study is to document the safety and tolerability of maca root, as well~     as any potential side effects that it causes. We suspect that Maca Root will result in a~     significant reduction in sexual dysfunction when compared to a placebo group.~   "
227819|NCT00575315|"~     Effective therapy for human immunodeficiency virus (HIV) infection has markedly prolonged~     survival in infected individuals. As a result, other diseases are now becoming clinically~     significant. Approximately 30% of HIV infected patients are co-infected with hepatitis C~     virus (HCV) which is now the leading co-morbid disease in co-infected individuals. The~     histologic severity and natural history of HCV has been reported to be accelerated in those~     co-infected with HIV. It is hypothesized that 1) the severity and progression of HCV disease~     is related to the immune competence of the individual, 2) immune restoration associated with~     HIV therapy may further accelerate the progression of HCV disease which may explain the~     marked increase in HCV related morbidity and mortality observed in recent years, and 3) the~     virologic response to anti-HCV treatment is directly related to the degree of immunologic~     competence. The specific aims of the proposal are: 1) To obtain, through multi-disciplinary~     didactic teaching, the necessary skills of clinical research design, data collection, data~     analysis, and biostatistical methods and 2) To study the impact of HIV disease on HCV, the~     effect of the immune function and immune restoration during HIV therapy on the natural~     history of HCV, and the efficacy of HCV treatment in HIV co-infection.~   "
227820|NCT00575302|"~     In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old~     are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment~     will be analyzed.~   "
227821|NCT00575276|"~     This study looks at the differences in inflammatory mediators in gallbladder tissue between~     males and females and the possibility that these differences contribute to a higher~     perception of post-operative pain in females following laparoscopic cholecystectomy.~   "
227822|NCT00575263|"~     The human tooth pulp has many nerve fibers and is a common source of pain. This study~     examines nerve fibers within normal and painful samples and identifies changes that can~     contribute to the generation of pain.~   "
227823|NCT00575250|"~     We wish to investigate whether a weekly, 2½ hour group-based osteoporosis education~     intervention (the Osteoporosis Prevention and Self-Management Course), is different to one~     session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing~     foods, confidence to exercise, and amount of exercise undertaken after three and nine months~     of follow-up in people aged over 50 years who have already had a bone fracture.~   "
227824|NCT00575237|"~     A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as~     nausea and vomiting after laparoscopic surgery.~   "
227825|NCT00575224|"~     The purpose of this research study is to test the safety, tolerability, and effectiveness of~     the drugs Pegasys and Copegus when used for hepatitis C genotypes 6, 7, 8, and 9. Patients~     are randomly assigned (by chance) to either Treatment Group A (Pegasys and Copegus for 24~     weeks) or Treatment Group B (Pegasys and Copegus for 48 weeks).~   "
227851|NCT00574873|"~     Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of~     bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase~     Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one~     year.~   "
227852|NCT00574860|"~     Randomized, double-blind, placebo-controlled study for the treatment of head and neck~     cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral~     mucositis(OM).~   "
228314|NCT00568646|"~     To determine the antitumor activity of MKC-1 in patients with unresectable or metastatic~     pancreatic cancer who have failed at least one prior chemotherapy regimen in either the~     neoadjuvant, adjuvant, or first-line metastatic setting~   "
227826|NCT00575211|"~     This is a multi-center, prospective evaluation of left ventricular recovery on conventional~     therapy in patients with the recent onset of dilated cardiomyopathy. In some subjects with~     this disorder, the heart will recover significantly over the first year, while others will be~     left with a chronically weak heart. The proteins that help the heart recover are encoded by~     genes, which can differ markedly between individuals. The goal of the current study is to~     determine whether variation in these genes involved affect the probability that the heart~     will recover. We will also look at which genes are involved in inflammation and which ones~     are turned on (producing proteins) in circulating white blood cells.{These statements will~     only be added if the site has chosen to participate in RNA analysis}. In addition, this study~     will look at how levels of proteins in the blood, proteins called cytokines' which control~     inflammation and proteins called neurohormones which are released when the heart weakens,~     affect the likelihood of recovery.~      Enrollment will take place at 15 centers. The goal is to enroll approximately 500 adult~     subjects (age 18 years or older, both men and women) over the course of approximately 48~     months.~   "
227827|NCT00575198|"~     The purpose of this study is to determine whether chest tubes can be safely removed without~     considering how much fluid is draining through the tube.~   "
227828|NCT00575185|"~     This will be a randomized, placebo-controlled, double-blind single-center proof of concept~     study to evaluate the anti-EBV activity of 4 grams of valomaciclovir (2 grams BID) for 21~     days in subjects with infectious mononucleosis documented to be caused by primary EBV~     infection. Otherwise healthy subjects (≥15 years old) referred to us with a clinical~     diagnosis of primary infectious mononucleosis will be screened and those with~     laboratory-confirmed primary EBV infection will be enrolled.~   "
227829|NCT00575172|"~     For the purpose of comparing efficacy of intensive therapy between 1) ultrarapid-acting type~     insulin (insulin aspart) and 2) conventional rapid-acting type insulin (R), a Multicenter~     Open Label Randomized Controlled Trial was planned in Japan using the occurrence of~     cardiovascular events in patients with diabetes, a high risk factor, as an index.~   "
227830|NCT00575159|"~     The purpose of this research study is to look at concentrations of GSK189075 in blood when~     single doses of the drug are taken by mouth in combination with basal insulin. The clinical~     effects of the drug in combination with insulin on the body will also be studied. The results~     will help determine doses of GSK189075 can be studied in the future in the type I diabetes~     mellitus population.~   "
227831|NCT00575146|"~     To determine whether a mild ketogenic diet can influences quality of life and survival of~     patients with recurrent glioblastoma~   "
227832|NCT00575133|"~     To assess the importance of intracellular signalling pathways and its deregulation in~     adiposity and diabetes-related insulin resistance, liver tissue samples of patients suffering~     from non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)will~     be analyzed prospectively from a liver tissue bank.~   "
227833|NCT00575120|"~     The purpose of this study is to assess the applicability of a new SSFP-based BOLD sensitive~     MRI sequence in evaluating endothelial function. Endothelial function will be tested in a~     setting of reactive hyperemia in the forearm. In a setting of ischemia-reperfusion, the~     effect of transient endothelial function impairment will be tested. Comparison with~     endothelial function assessment by brachial ultrasound (FMD) and finger tip plethysmography~     (PAT) will be incorporated.~      Hypothesis: BOLD-MRI is a feasible tool to assess endothelial function in the human forearm~     during reactive hyperemia. There is significant correlation to established flow-mediated~     dilation (FMD).~   "
227834|NCT00575107|"~     Evaluation of a new exercise machine designed to improve strength and speed of movement in~     the leg muscles. Investigators are trying to learn whether a new training method results in~     greater strength improvements as compared to a traditional method.~   "
227835|NCT00575094|"~     To purpose of this study is to assess the safety and tolerability of intravenous (IV)~     tigecycline in hospitalized subjects of Japanese descent with community-acquired pneumonia~     (CAP).~   "
227836|NCT00575081|"~     The NIH grant has funded the development of a physiological brain atlas registry that will~     allow us to significantly improve the data collectioin and use of physiological data into a~     normalized brain volume. This initially was used to improve DBS implants for Parkinson's~     Disease, Dystonia, Essential Tremor, and OCD, but now includes data acquired during all~     stereotactic brain procedures.~   "
227837|NCT00575068|"~     The purpose of this study is to determine whether anti-CD80 monoclonal antibody (IDEC-114) is~     effective in the treatment of follicular B-cell non-Hodgkin's lymphoma. This drug has never~     been studied in patients with lymphoma, however, it has been studied in psoriasis patients at~     various dose levels and schedules.~   "
227838|NCT00575055|"~     This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple~     dose study in male and female patients ages 50 to less than 89 years with mild to moderate~     AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be~     randomized to receive either bapineuzumab or placebo. Each patient's participation will last~     approximately 1.5 years.~      Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid~     peptide, and is designed to provide antibodies to beta amyloid directly to the patient.~   "
227839|NCT00575042|"~     This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with~     primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.~   "
227853|NCT00574847|"~     Depression is commonly seen in patients with cardiovascular disorders. In recent studies it~     has been shown that mild to moderate depression symptoms were associated with increased~     likelihood of mental stress-induced myocardial ischemia (MSIMI), which is a risk factor of~     poor cardiac outcome. In this project, the investigators aim to assess the treatment of~     mental stress-induced myocardial ischemia in ischemic heart disease patients with mild to~     moderate depressive symptoms. This study is a six-week double-blind placebo controlled study~     to examine the effects of escitalopram on mental stress-induced myocardial ischemia. This~     study will look to show that patients with ischemic heart disease who are treated with~     escitalopram will exhibit a significant improvement of MSIMI at the end of week 6 compared to~     patients receiving placebo.~   "
227917|NCT00574015|"~     This study will compare the degree of pain control provided by two techniques for persons~     with toothache in an emergency department. The two techniques include;~        -  standard oral narcotic pain medication~        -  numbing the tooth with local anesthetic by needle injection~   "
227840|NCT00575029|"~     Megestrol Acetate (MA) is a progesterone-like hormone that has been utilized as a birth~     control agent, chemotherapeutic drug, and more recently, to induce appetite and weight gain~     in patients malnourished as a result of radiation therapy, chemotherapy, cystic fibrosis,~     AIDS, or dementia. The mechanism of MA-stimulated appetite and weight gain is unknown.~      Although only approved to combat weight loss associated with AIDS and cancer, MA is~     frequently prescribed for long periods of time to prevent or reverse weight loss in nursing~     home residents and in elderly patients with serious illnesses in the community. Little data~     is available to support this practice. Among its many properties, MA acts as a partial~     glucocorticoid agonist, and long term and short term use of MA may results in adrenal~     suppression. The rapidity of the onset of MA-induced adrenal suppression and the time course~     of resumption of normal adrenal function after discontinuation of MA is completely unknown.~     As a consequence, it is unclear whether MA can be given safely for short periods of time or~     whether glucocorticoid administration is necessary after abruptly stopping MA treatment. The~     increased use of MA in the frail elderly, where even partial adrenal insufficiency may pose a~     substantial risk of adrenal crisis after an illness, requires a clear understanding of these~     issues. To address these concerns, we will evaluate adrenal function before, during, and~     after MA administration in healthy volunteers between the ages of 60 and 85 years.~   "
227841|NCT00575016|"~     The purpose of this study is to explore the effectiveness and safety of several doses of~     botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.~   "
227842|NCT00575003|"~     The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or~     cat allergy compared to placebo in adult patients.~   "
227843|NCT00574990|"~     The purpose of this research study is to examine the clinical processes of care involved with~     the sharing and communicating of medication management information in the inpatient setting~     between nurses, pharmacists and physicians. The study is unique in that few studies have~     examined communication content and processes in depth and in relation to specific clinical~     care. The study will be conducted in two phases. The first phase involves using three focus~     groups across three sites (a total of nine) each involving between 6-8 individuals to examine~     perceptions regarding role and procedures associated with medication management. The focus~     group discussions will be tape-recorded and analyzed using qualitative methods. The~     information gleaned will assist us in identifying patterns of problems in enhancing the~     sharing of information, to develop better measures for assessing communication as well as~     designing effective interventions to enhance communication.~      In the second phase of the study, 400 2-4 hour time slots will be randomly selected over~     about a 5-week period for nursing staff and 500 events over a 6-week period for physicians to~     conduct ethnographic observations during which specific communication events will be recorded~     and coded. Every effort will be made to minimize interruptions during clinical care. This~     research has not been done in terms of medication management content in the inpatient setting~     (non-ICU).~   "
227844|NCT00574977|"~     The purpose of this study is to determine the safety and maximum tolerated dose from~     injecting this vaccinia virus into tumors or infusion.~   "
227845|NCT00574964|"~     The purpose of this research study is to determine if combining all three treatments of~     Gliadel wafers, Temozolomide and Radiation therapy at the same time is safe and more~     effective than one treatment at a time. The study will measure the survival of subjects~     treated with this combination of drugs.~   "
227846|NCT00574951|"~     RATIONALE: AMG 706 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well AMG 706 works in treating patients with~     persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary~     peritoneal cancer.~   "
227847|NCT00574925|"~     The primary objective of this study is to investigate whether eradication treatment of~     Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the~     time to relapse in patients with gastroesophageal reflux disease (GERD).~      A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14~     days that are equal or above the critical value of 25.~      The secondary objectives are~        1. To compare the time to relapse in the two H. pylori positive study groups with the H.~          pylori negative control group~        2. To compare the pattern of inflammation and atrophy in the two H. pylori positive~          treatment groups with the naturally H. pylori negative control group at relapse.~        3. All the above objectives analyzed for the efficacy subset that is the per-protocol~          patients broken down by effective H. pylori-eradication.~      Secondary endpoints will be analyzed by the following parameters and their interactions:~        1. Treatment : Eradicated, Non-eradicated, Hp-negative control~        2. Esophagitis at study start: grades 0, A/B and C/D~        3. Gender~        4. Alcohol intake~        5. NSAID/ASA intake (for histological results)~             -  Trial with medicinal product~   "
227848|NCT00574912|"~     The study is to determine the dose response relationship of insulin glargine in type 2~     diabetes over a 24-hour period and measuring the differences in glucose production among the~     differing doses of glargine.~      Hypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will~     show differing effects on endogenous glucose production, glucose disposal and carbohydrate~     and lipid flux.~   "
227849|NCT00574899|"~     Radical Prostatectomy (removal of the prostate) or radiation therapy provide excellent~     outcomes for patients with localized (confined to one area) disease, yet there is still no~     effective treatment once the disease has spread beyond the prostate gland. Typically, a serum~     PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy and~     other tests help to classify the patient's disease according to the likelihood of a~     recurrence. However, these assessments are imperfect. There is a need to identify and~     evaluate prostate biomarkers that will provide exact information regarding the likelihood of~     a recurrence (prediction) of prostate cancer.~   "
227850|NCT00574886|"~     This trial was made available as a compassionate use protocol for patients who failed~     induction chemotherapy + Vaccine on trials 197-99 and 196-99. These follicular NHL patients~     then went on to high dose BEAM chemotherapy and transplant. Patients received idiotype~     vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a~     fifth series given 12 weeks after the fourth. Patients are then followed annually until~     progression or death with standard staging. Immune response testing continues annually on~     patients who continue to have a response post transplant.~   "
227854|NCT00574834|"~     The study will be focused on determining the integrated in-vivo mechanisms responsible for~     Ramipril's effects on delaying type 2 diabetes and restoring normal (blood sugar levels)~     glycemia in patients with impaired glucose tolerance.~      Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal~     glycemia in patients with impaired glucose tolerance.~   "
227855|NCT00574821|"~     The purpose of this research study is to further establish the diagnostic use of~     magnetocardiography (MCG) in patients with hypertrophic cardiomyopathy (HCM). The use of MCG~     has not been extensively studied in these patients. This pilot study will serve to further~     characterize abnormalities found on MCG in comparison to patients without hypertrophic~     cardiomyopathy. Additionally, the study will be used to understand whether MCG has any~     additional diagnostic utility in offering clinicians insight on the patient's disease state,~     thereby aiding in the development of treatment plans.~      This research study is designed to test the effectiveness of the investigational use of~     magnetocardiography in patients with hypertrophic cardiomyopathy. The device itself has been~     approved by the U.S Food and Drug Administration (FDA).~   "
227856|NCT00574808|"~     The aim of the proposed study is to implement and evaluate Outreach Facilitation as a means~     to increase the uptake of evidence-based practice for secondary prevention and management of~     patients with established CVD and cardiovascular risk factors, in primary care practices~     throughout the Champlain LHIN. This initiative centers on the use of an Outreach Facilitation~     Model, in which skilled health professionals known as facilitators (Practice Change~     Consultants) serve as an expert resource to primary care practices in three areas: a)~     practice performance assessment, feedback, and consensus building towards goal setting and~     implementation; b) clinical, technical, organizational resources and practical advice; and c)~     encouragement to face and move through the challenges associated with implementing system~     change.~   "
227857|NCT00574795|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the~     13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.~   "
227858|NCT00574782|"~     In an observational multi-centre study (CHALLENGE), the effects were assessed of starting~     treatment with low doses of rosuvastatin in statin naive patients with a history of coronary~     heart disease (CHD), peripheral vascular disease (PVD), cerebrovascular accident (CVA),~     transient ischemic attack (TIA) or diabetes (DM), on low-density lipoprotein cholesterol~     (LDL-C) goal achievement. Also proportional changes in LDL-C, high-density lipoprotein~     cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG) and the ratio TC/HDL-C were~     studied.~   "
227859|NCT00574769|"~     Prostate cancer is a common and important health issue. Although effective treatment is often~     available for localized disease, metastatic prostate cancer remains incurable. The initial~     treatment for metastatic prostate cancer often includes medical or surgical treatments that~     deprive the tumor of male hormones (androgens) required for growth. Although this treatment~     is successful for many patients, the cancer may eventually return in others. Recurrent~     prostate cancer may be treated with additional hormonal agents, but these agents usually do~     not result in long-term control of the disease. Eventually most patients with recurrent~     prostate cancer progress to a state where the cancer grows despite very low level of~     circulating male hormones known as androgen independent prostate cancer (AIPC).~   "
227860|NCT00574756|"~     The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved~     medication for the treatment of angina, on heart function by using echocardiography.~   "
227861|NCT00574743|"~     This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in~     de novo heart recipients.~   "
227862|NCT00574730|"~     This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with~     rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent~     non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression,~     molecular response, and immunologic parameters related to this treatment.will have an ocular~     exam prior to treatment.~      Patients in this study will receive 6 cycles of combination chemotherapy with the standard~     CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for~     six to eight cycles. Patients achieving at least a partial response to chemotherapy will~     begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be~     continued for 12 months in the absence of signs of progressive/recurrent disease, or~     unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the~     presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone~     marrow evaluation for molecular testing at baseline. Those found to be positive will have~     repeat assessments performed post induction therapy, and after six months of PEG Intron.~     Patients will also undergo immunologic evaluation at baseline, post induction therapy, and~     after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease~     reevaluation and then annual data collection for long-term toxicity, duration of response and~     survival.~   "
227863|NCT00574717|"~     To determine if wearing a moderate spectacle under-correction (3.00D) and performing~     activities designed to stimulate accurate accommodation during a 15-month period will enhance~     emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.~   "
227864|NCT00574704|"~     The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in~     patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a~     double-blind, placebo-controlled setting~   "
227865|NCT00574691|"~     To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to~     facilitate hemostasis in patients undergoing diagnostic or interventional procedures.~   "
227866|NCT00574678|"~     This study will further evaluate the use of protein identification or protein pattern~     (signature) found in tears. We hypothesize that differences exist between the protein profile~     in tear fluid from patients with versus without cancer.~   "
227867|NCT00574665|"~     The purpose of this study is to learn more about why patients with diabetes have increased~     heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood~     vessel. The proposed protocol will study the separate and combined effects of hyperglycemia~     and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM. Our~     hypothesis is that hyperglycemia, rather than hyperinsulinemia, is responsible for the~     dysregulation of fibrinolytic balance in diabetics.~   "
227868|NCT00574652|"~     A systemic Vasculitis is found in 5 to 10% of HCV infected patients with mixed~     cryoglobulinemia (MC). It mainly involves the skin, peripheral nerve and the kidney and may~     be life threatening. Twenty to 30% of HCV-MC Vasculitis patients are resistant to~     conventional therapy (i.e. antiviral therapy and/or immunosuppressors) and still have an~     active disease. Thus, new therapeutic approaches are necessary in such patients. We recently~     described a regulatory T cell (Treg) deficiency in HCV-related Vasculitis patients.~     Immunomodulatory effects of interleukin-2 (IL-2) are well established, notably the~     preferential expansion of Treg able to suppress inflammatory responses mediated by CD4+ and~     CD8+ T cells.~   "
227869|NCT00574639|"~     The purpose of this study is to determine the way by which Alprazolam (Xanax) an anti-anxiety~     drug affects specialized molecules in your brain called GABA (A) receptors that alter your~     body's ability to defend itself from low blood sugar (hypoglycemia). We hypothesize that~     prior activation of GABA (A) receptors may result in blunting of counterregulatory responses~     during subsequent hypoglycemia and exercise.~   "
227870|NCT00574626|"~     The purpose of this study is to evaluate the difference in relapse rates and long term event~     free survival in patients with intermediate grade or immunoblastic non-Hodgkin's lymphoma~     (NHL) whose marrow is not obviously involved with NHL who are randomized to receive either an~     autologous bone marrow (ABMT) or peripheral stem cell transplant (PSCT). All patients with~     intermediate grade NHL with histologic negative bone marrow who would otherwise meet all~     eligibility criteria for high-dose therapy and ABMT are eligible for this study. Patients who~     are eligible will be randomized to either PSCT or ABMT at the time of enrollment into our~     transplant program.~   "
227871|NCT00574613|"~     Transforming growth factor-beta 1 (TGF-β1) is consistently over expressed in most fibrotic~     diseases and displays a variety of profibrotic effects in fibroblasts. Activation of TGF-β~     receptors induces the activation of several kinase signalling cascades leading to the~     phosphorylation of SMAD proteins as well as to the activation of SMAD-independent kinases~     that collectively activate ECM synthesis and fibroblast growth and differentiation into~     myofibroblasts. TGF-β1 is one of the main mediators in the fibrotic process, associated to~     both scarring and a long list of pathologies related to chronic inflammation and which affect~     all type of organs and tissues. An increase in TGF-β1 mRNA and protein levels has been~     described in these processes. Peptide 144 (P144) is the acetic salt of a 14mer peptide from~     human TGF-β1 type III receptor (betaglycan). P144 TGF-β1-inhibitor has been specifically~     designed to block the interaction between TGF-β1 and TGF-β1 type III receptor, thus blocking~     its biological effects. P144 has shown significant antifibrotic activity in mice receiving~     repeated subcutaneous injections of bleomycin, a widely accepted animal model of human~     scleroderma, and could contribute to the development. The purpose of this study is to asses~     the efficacy and safety of topical application of P144 in the treatment of skin fibrosis in~     patients with systemic sclerosis.~   "
227872|NCT00574600|"~     The purpose of this study is to evaluate the safety of and immune response to an experimental~     DNA HIV vaccine followed by boosting with an experimental modified vaccinia HIV vaccine (MVA)~     in HIV uninfected adults.~   "
227873|NCT00574587|"~     Chemotherapy plus trastuzumab (Herceptin) are standard treatments for breast cancer. There~     are circumstances where these treatments are given prior to surgery to reduce the size of the~     cancer and imptove the surgical outcome. In this trial, an oral drug called vorinostat will~     be given in combination with chemotherapy and trastuzumab. Vorinostat is a histone~     deacetylase (HDAC) inhibitor which is approved by the U.S. Food and Drug Administration for~     the treatment of a rare type of cancer involving the skin (cutaneous T cell lymphoma), but~     not for breast cancer. HDAC inhibitors work by unsilencing tumor suppressor genes and other~     genes in the cancer cells that are repressed; when the genes are turned back on by the drug,~     it leads to death of the cancer cells. HDAC inhibitors such as vorinostat have been shown to~     enhance the effects of chemotherapy and trastuzumab in experimental systems. The purpose of~     this trial is to determine the optimal dose of vorinostat to use in combination with standard~     chemotherapy plus trastuzumab, and to determine whether vorinostat enhances the effectiveness~     of standard chemotherapy plus trastuzumab.~   "
227874|NCT00574574|"~     The purpose of this study is to determine whether short-term exposure to a compound found in~     some fruits and vegetables (anthocyanin), is effective in improving skin health and reducing~     the levels of various markers of cardiovascular disease risk. A range of skin health~     parameters are being studied and volunteers are also providing skin biopsy, urine and blood~     samples. 62 postmenopausal women have been recruited for this study.~   "
227875|NCT00574561|"~     The investigators wish to study the magnetic field map using magnetocardiography (MCG) in~     subjects undergoing computed tomographic angiography (visualization of the heart arteries~     using CT scanning, CTA). The main purposes is to investigate if MCG is capable of detecting~     the presence of obstructive coronary artery disease (CAD) as detected by CT angiography (CTA)~     as well if the MCG can exclude the presence of CAD as defined by CTA.~      Secondarily the investigators will look at the correlation of MCG with non-obstructive CAD~     and the correlation of MCG with other tests (treadmill testing, stress echo or nuclear scan,~     coronary angiography) done as part of the work up for CAD.~   "
227876|NCT00574548|"~     The objective of this study is to compare the safety, tolerability and immunologic response~     to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that~     have never received a previous dose of 23vPS.~   "
227897|NCT00574275|"~     The main objective of the study was to evaluate the effectiveness of aflibercept treatment by~     comparison to placebo in increasing the overall survival (OS) in participants with metastatic~     pancreatic cancer, treated with gemcitabine.~      The secondary objectives were to evaluate progression free survival, clinical benefit,~     overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1:~     Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).~      The study included an interim analysis of OS. In accordance with the study protocol, an~     interim analysis was performed for the purpose of futility and overwhelming efficacy. On the~     basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this~     study be terminated for futility based on predefined boundary rules.~   "
227898|NCT00574262|"~     The purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using~     a new developed clinical pathway.~   "
227918|NCT00574002|"~     The purpose of the study is to evaluate a safe threshold for when to remove chest tubes in~     patients based on the amount of drainage present.~   "
227877|NCT00574535|"~     Heart disease is not just the number one killer of women, it is also a leading cause of~     disability. While it is generally believed that heart disease in women is a disease of old~     age, the stark reality is that heart disease is responsible for more deaths than breast~     cancer AT ALL AGES. Also, when young women develop heart disease, they are more likely to die~     or become disabled than their male peers. Identifying women at risk for heart disease is an~     important step toward reducing the impact of this disease.~      Although women can develop heart disease at any age, most women show signs and symptoms of~     disease about 10 years after men. For years, it has been thought that the reason for this lag~     is that women's hearts are protected by estrogen, and that when women go through menopause~     and lose their natural estrogen, they also lose their protection from heart disease. It has~     been assumed that if estrogen is replaced then protection will continue. These assumptions~     have not been proven. In fact, three large, randomized trials have shown no benefit from~     hormone replacement therapy in women known to have heart disease, and in fact have shown that~     hormone replacement may be harmful.~      To better understand the role of hormones and heart disease, the investigators propose to~     look at markers of heart disease in healthy women and compare this to their natural hormone~     levels. One of the markers known to be related to heart disease is carotid artery~     intima-medial thickness (c-IMT) which can be measured by creating an ultrasound picture of an~     artery in the neck. The investgators will use c-IMT scans and serum blood samples from women~     in the NIH-sponsored Los Angeles Atherosclerosis Study (LAAS), a large epidemiologic study~     that followed participants for 8 years. The proposed study will use risk factor information,~     serum samples and c-IMT scans collected from the female participants (about 269 women) over~     the 8 years of follow-up. The total sample size is 269 subjects, each of whom donated 3 blood~     specimens for the LAAS study. This research will examine those specimens (800 in total). It~     will also measure other markers of heart disease, including inflammation (hsCRP) and diabetes~     (insulin and glucose). All information has been obtained and there will be no need to collect~     additional information from participants nor additional blood specimens.~   "
227878|NCT00574522|"~     The investigators are proposing that energy specific electromagnetic radiation of the central~     nervous system, the viscera and the endocrine system has the potential to enhance the immune~     system; thereby enhancing the production of killer cells to fight and destroy the human~     immunodeficiency virus.~   "
227879|NCT00574509|"~     The purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when~     combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell~     transplantation. The study will also compare the difference in response rates and time to~     treatment failure between historical control patients receiving high-dose BEAM or BEAC~     chemotherapy with autologous hematopoietic stem cell transplant and patients receiving~     radioimmunotherapy and high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem~     cell transplant. Patients will receive escalating doses of radioimmunotherapy with anti-B1~     radiolabeled with 131Iodine, high-dose carmustine, etoposide, cytarabine and Melphalan (BEAM)~     chemotherapy, and autologous hematopoietic stem cell transplant.~   "
227880|NCT00574496|"~     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of~     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. When the healthy stem cells from a donor are infused into the patient they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells. Giving cyclosporine, mycophenolate mofetil, and methotrexate before and after~     transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by donor~     stem cell transplant works in treating patients with relapsed or high-risk primary refractory~     Hodgkin lymphoma.~   "
227881|NCT00574483|"~     The overall response to standard therapies and to the newer antiangiogenesis therapies is not~     curative, and treatment-associated toxicities may be severe. Therefore, continued evaluation~     of therapies, with different mechanisms of action, is needed for patients with metastatic~     RCC.~   "
227882|NCT00574470|"~     The purpose of this study is to see whether serious graft versus host disease which is not~     well controlled with steroid treatment can be controlled with therapy with both daclizumab~     and infliximab. We hypothesize that a combination of daclizumab and infliximab will more~     effectively treat graft versus host disease than therapy with a single drug. The study also~     looks at whether chronic graft versus host disease develops, and survival at 6 and 9 months~     post-treatment.~   "
227883|NCT00574457|"~     1) Research questions:~      1a. Can non-sonographer health care professionals in a community medical office practice~     setting be trained to detect and evaluate subclinical atherosclerosis?~      1b. Can carotid ultrasound performed in community office practices improve physician use of~     evidence-based, risk-reducing interventions and patient motivation to adhere to therapeutic~     recommendations?~   "
227884|NCT00574444|"~     We propose a phase I study of laparoscopic assisted, transvaginal peritoneoscopy by using~     flexible endoscopy in female patients with pelvic pain. It is designed as a hybrid procedure~     with laparoscopy using one port for adequate safety with the ultimate goal in the future that~     transvaginal NOTES can replace therapeutic pelviscopy for this indication. The standard~     number of port sites for diagnostic laparoscopy is 2-3. By reducing the number and size of~     laparoscopic port, patients should already experience benefits from this hybrid procedure.~   "
227885|NCT00574431|"~     Nutritional treatment has become an essential component of the management of critically ill,~     due to better knowledge about positive impact of nutritional support. Malnutrition among ICU~     patients is associated with increased morbidity, mortality, length of stay (LOS) and~     therefore higher costs.Several studies however suggest, that early implementation of~     nutritional support is associated with improved clinical outcome, shorter LOS, and decreased~     infection rates. One of the objectives of this study is to determine if an nutrition protocol~     can improve the delivery of enteral tube feeding in the ICU.~   "
227886|NCT00574418|"~     A preliminary study to determine the efficacy of using energy specific far infrared (FIR)~     radiation for the treatment of uterine fibroids.~   "
227899|NCT00574249|"~     The objective of this study is to assess the efficacy and safety of adalimumab in combination~     with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination~     with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.~   "
227900|NCT00574236|"~     Primary objective is to determine the effectiveness of the combination of bortezomib and~     doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase~     II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with~     doxorubicin IV on days 1 and 8 of a 21-day cycle.~   "
227901|NCT00574223|"~     The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in~     patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a~     double-blind placebo-controlled setting~   "
227968|NCT00573326|"~     The purpose of this study is to verify effect and tolerability of imatinib on pulmonary and~     skin fibrosis in patients affected by systemic sclerosis.~   "
227887|NCT00574405|"~     Type I diabetes (T1DM) is the second most common chronic illness effecting children in the~     USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology~     remains elusive. Nevertheless, recent data supports the notion that early and intensive~     management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may~     significantly improve beta cell function and insulin secretion over ensuing years. To this~     end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous~     B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we~     anticipate that early use of an insulin pump will improve glycemic control beyond that~     achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by~     the patient. These data will provide important pilot information to explore the potential~     role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type~     I diabetes. The specific aim of this study is to test the following hypothesis: Early use of~     insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic~     B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an~     insulin pump will improve glycemic control beyond that achieved with standard multiple~     injection therapy, and will be well-tolerated by the patient.~   "
227888|NCT00574392|"~     The purpose of this study is to image skin and skin lesions with a new imaging technology~     called multiwavelength and coherence confocal reflectance microscopy. This technology uses~     low intensity laser to image below the surface of the skin. This technology may provide a new~     way of looking at skin and skin lesions. The goal of this study is to evaluate the images of~     your skin taken by this microscope.~      The techniques being evaluated in this study use multi wavelength and coherence confocal~     reflectance microscopy invivo. The term in vivo means in/on a living subject. In this study~     you will be the living subject and the multi wave length and coherence confocal microscope~     will be placed on your skin to look at your skin lesions and your normal skin. The confocal~     microscope uses a weak laser light and a sophisticated lens to image the individual cells~     that make up the skin. Your lesion will be photographed with high resolution photography. An~     area near your skin lesion that is clinically normal will also be imaged in the same manner.~   "
227889|NCT00574379|"~     Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either~     once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in~     the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline~     in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.~   "
227890|NCT00574366|"~     RATIONALE: Erlotinib and everolimus may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Giving erlotinib together with everolimus may kill more~     tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving erlotinib~     together with everolimus and to see how well it works in treating patients with metastatic~     breast cancer.~   "
227891|NCT00574353|"~     When used with a different radioactive tracer called FMISO, a PET scan can find areas of low~     oxygen in the tumor. We think that having areas of low oxygen is a reason why some tumors are~     hard to treat with radiation.~      In a past study, FMISO PET scans were performed in 6 patients with rectal cancer that could~     not be operated on and that had spread to other areas. In this group of patients, FMISO PET~     scans were able to find the low oxygen areas in their tumors. But this study included only a~     few patients. In the present study, we want to use FMISO PET scans in patients who have~     tumors that can be operated on. This group of patients will have radiation, chemotherapy or~     both before they have their surgery. We want to see if FMISO PET can find low oxygen areas in~     this distinct group of patients.~   "
227892|NCT00574340|"~     Hypoglycemia (low blood glucose level) occurs frequently in intensively treated patients with~     diabetes. Although hypoglycemia was thought to occur almost exclusively in T1DM, with the~     advent of improved metabolic control in T2DM, the incidence of hypoglycemia is rising in~     these patients. Therefore in this application, we will test the novel hypothesis that prior~     hypoglycemia will result in (cardiovascular complications) during subsequent hypoglycemia.~   "
227893|NCT00574327|"~     The purpose of this study is to determine or evaluate the risk factors such as smoking,~     family history etc. that cause esophageal cancer and to determine the genetic changes that~     lead to esophageal cancer. The investigators hypothesis is that systematic collection of data~     on the natural history of GERD and BE patients and risk factors for development of BE in~     patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide~     useful information to develop a decision model for risk stratification and risk reduction~     strategies in these patients.~      As of March 17, 2011, 585 patients have consented at the Kansas City VA Medical Center.~   "
227894|NCT00574314|"~     Women have been disproportionately underrepresented in clinical research. Few of the many~     drugs approved by the FDA have been adequately tested in women. Most common health conditions~     experienced by both women and men are managed by treatments that have been developed and~     tested most in men.~      A new barrier to enrolling women in clinical trials is in effect: HIPAA (the Health Insurance~     Portability and Accountability Act). The positive benefit of HIPAA—protecting a person's~     health information from abuse—is laudable, but it comes at a cost: it will deny investigators~     the benefit of access to chart (medical record) review in order to gather data to answer~     clinical questions. In the past, investigators were allowed access to patient's charts~     because the hospital consent form included a clause indicating that the patient's information~     may be used for research.~      The investigators propose to overcome this crisis and challenge with a proven method of~     identifying individuals who would be willing to consider participating in a clinical trial:~     The Women's Guild Health Research Registry. In keeping with the focus of the Women's Health~     Program, we would propose to enroll only women. The registry will allow qualified~     investigators to identify potential study participants. This idea has been effective at~     improving the quantity and quality of women able and willing to participate in trials.~      The investigators will also allow other approved sites to utilize the Registry via the~     approved procedure of submitting an IRB approved protocol which will be reviewed by our~     Internal Review Committee. This protocol's inclusion/exclusion criteria will be used to query~     the database for eligible participants. The participants will be contacted by the Registry~     staff to ascertain their interest in this research protocol and their agreement to release~     their contact data to the investigator will be obtained.~      Investigators will be charged at the time they approach the registry for assistance. The~     charge is intended to cover the cost of maintaining the registry now that initial funding has~     been exhausted.~   "
227895|NCT00574301|"~     We hypothesize that radiofrequency ablation after single-insertion image guided vacuum~     assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast~     cancers (≤1.5 cm).~   "
227896|NCT00574288|"~     Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with~     multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies~     and without further established treatment options.~   "
227902|NCT00574210|"~     The purpose of this study is to evaluate the relative efficacy of four dosing regimens of~     bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen~     using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores~     (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history~     of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two~     ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months~     prior to randomization.~   "
227903|NCT00574197|"~     Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of~     mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of~     transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of~     Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of~     acute kidney rejection only. There is no clinical data of its use in heart transplant~     patients.~   "
227904|NCT00574184|"~     The specific aim of this pilot study is to describe the angiographic prevalence and pattern~     of internal pudendal artery (and associated inflow vessel) atherosclerosis in patients with~     erectile dysfunction who are non-responsive to PDE-5 inhibitors (i.e., Viagra) who are~     referred for clinically-indicated cardiac catheterization.~   "
227905|NCT00574171|"~     The purpose of this study is to find out how effective this combination is as a second line~     treatment for colorectal cancer that has spread from one part of the body to another~     (metastasized) or has not metastasized but is considered inoperable (unable to be removed by~     surgery). The side effects and survival experienced by subjects receiving these drugs will~     also be evaluated. This is a phase II research study.~   "
227906|NCT00574158|"~     The goals of the research are designed to accomplish genetic association studies of candidate~     genes in healthy normal individuals exposed to 0.2 ppm for 2.25 hours with intermittent~     exercise in order to search for associations between defined genotypes/haplotypes and 3~     specific in vivo respiratory endpoints: a) change in FEV1 immediately after ozone exposure;~     b) change nonspecific bronchial reactivity as reflected in the change in methacholine PC20~     FEV1 24 hours after ozone exposure ; and c) change in lung epithelial integrity as reflected~     in the Clearance Halftime of technetium 24 hours after ozone exposure. These studies have~     been carried forward to take place in 4 phases:~      i) healthy individuals have been exposed to O3 using our standard exposure protocol; and we~     will increase the numbers of individuals available for study.~      ii) perform genetic association studies for the endpoints of spirometry (FEV1, FVC,~     FEV1/FVC), PC20 FEV1 for methacholine, and epithelial integrity (Clearance Halftime) for 3~     candidate O3 response genes taken from literature searches and/or previously characterized to~     demonstrate associations. These physiologic endpoints have been examined in terms of both a~     continuum of response, and discrete responder and non-responder endpoints.~   "
227907|NCT00574145|"~     RATIONALE: Healing touch therapy may be effective in lessening fatigue in women with breast~     cancer who are undergoing radiation therapy.~      PURPOSE: This randomized clinical trial is studying how well healing touch works in treating~     fatigue in women undergoing radiation therapy for breast cancer.~   "
227908|NCT00574132|"~     This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose~     study in male and female patients ages 50 to less than 89 years with mild to moderate AD.~     Approximately 230 study sites in the US and Canada and up to 35 sites outside of North~     America will be involved. Patients will be randomized to receive either bapineuzumab or~     placebo. Each patient's participation will last approximately 1.5 years.~      Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid~     peptide, and is designed to provide antibodies to beta amyloid directly to the patient.~   "
227909|NCT00574119|"~     We plan to study the concept of energy starvation in heart failure by evaluation of~     patients with nonischemic dilated cardiomyopathy (NIDCM) (heart failure with reduced heart~     pump function due to causes other than heart attack). We will use a combination of positron~     emission tomography and magnetic resonance imaging to study metabolism, anatomy, function,~     blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone~     which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart~     muscle).~   "
227910|NCT00574106|"~     Cancer is the number one killer in Canada and in most countries of the world. The~     investigators' initial assessment indicates that far infrared radiation has the potential to~     cure cancer.~   "
227911|NCT00574093|"~     This study is designed to evaluate the effect of Visudyne® combination therapy (Visudyne®~     [verteporfin for injection] and Lucentis™) on visual acuity outcomes. Study results will be~     submitted for publication to provide data that may help physicians refine the clinical~     management of patients with CNV secondary to age-related macular degeneration (AMD).~   "
227912|NCT00574080|"~     Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose~     chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve~     myeloma response and acquire longer survival for participants.~   "
227913|NCT00574067|"~     This five-year study examines the effectiveness of buprenorphine treatment provided to~     previously-addicted inmates(N=320; 160 males, 160 females) initiated in prison and continued~     in the community. The study also examines the extent to which the setting of post-release~     buprenorphine is provided.It is expected that participants receiving in-prison buprenorphine~     will have superior outcomes compared to participants who did not receive in-prison~     buprenorphine.~   "
227914|NCT00574054|"~     This trial is a preliminary study to determine the use of far infrared radiation for the~     treatment of dementia and other mental sickness.~   "
227915|NCT00574041|"~     This study is to find out if starting at low dose Avonex and slowly increasing to full dose~     will improve flu like symptoms as a side effect of Avonex treatment.~   "
227916|NCT00574028|"~     The objective and aims of this study is to develop The University of California Irvine~     Medical Center Inflammatory Bowel Disease Research Registry for the purpose of:~        1. Performance of retrospective studies on inflammatory bowel disease to assess disease~          outcomes and response to therapy.~        2. Obtaining permission from the Research Registry participants to be contacted by members~          of The University of California Irvine Medical Center Inflammatory Bowel Disease~          Research Center to identify patients that may be eligible for participation in future~          research studies.~        3. Performance of studies to quantify disease phenotypes and treatment patterns.~   "
227919|NCT00573989|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as~     pemetrexed and erlotinib, may make tumor cells more sensitive to radiation therapy. Erlotinib~     and pemetrexed may also stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving intensity-modulated radiation therapy together with pemetrexed and~     erlotinib may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when~     given together with intensity-modulated radiation therapy and pemetrexed and to see how well~     they work in treating patients with recurrent or second primary head and neck cancer.~   "
227920|NCT00573976|"~     In the past two decades there have been great strides made in understanding the biological~     changes resulting from spinal cord injury (SCI). The future holds promise of the development~     of therapies that will promote degrees of repair and recovery of function for people living~     with SCI. Lessons learned from past failed SCI clinical trials, however, demonstrate that,~     in order to accurately evaluate the overall effectiveness of SCI therapies, more sensitive~     outcomes measures are needed. Specifically, and reflecting the ultimate goal of clinical~     interventions - inducing functional recovery - the Spinal Cord Independence Measure (SCIM),~     has been recommended for further testing and development for use as a measure of functional~     ability in future SCI clinical studies. The SCIM is a very simple questionnaire and score~     sheet that an evaluator uses to determine how independently a person with SCI can perform~     certain tasks.~      A panel of SCI researchers recommended the SCIM as the most suitable among four candidate~     measures of functional recovery reviewed at a special meeting sponsored by the National~     Institute on Disability and Rehabilitation Research (NIDRR) at a joint meeting of the~     American Spinal Injury Association and the International Spinal Cord Society (ASIA-ISCoS) in~     Boston, MA, in June 2006. It was recommended that a large-scale, multi-center, prospective~     trial be conducted in the United States, which would mirror a recently published multi-site~     international study.~      The proposed research on the SCIM III, the latest and most sensitive version of the SCIM,~     would test the hypothesis that the SCIM III is a valid, reliable, and sensitive measure of~     functional ability in persons with SCI. Twenty-two rehabilitation centers throughout the~     United States will enroll a maximum of 660 subjects. Functional ability will be measured with~     the SCIM III during the first week of admittance into inpatient acute rehabilitation and~     within one week of discharge from the same rehabilitation program. Statistical analyses will~     be used to test the validity, reliability, and sensitivity of the SCIM III. The results will~     demonstrate whether the SCIM III is a suitable outcome measure to assess SCI specific~     functional ability in future clinical trials.~   "
227921|NCT00573963|"~     The purpose of this study is to determine if patients having the transversus abdominal place~     (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than~     those who do not. Freezing medication is injected between the layers of muscle on either side~     of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This~     technique has been useful for many abdominal operations, and has recently been studied in~     cesarean sections, however more information is needed.~   "
227922|NCT00573950|"~     Cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication.~     Cilostazol inhibits phosphodiesterase III (PDE III), which causes it to be a vasodilator and~     inhibitor of platelet aggregation. Recently there were report of beneficial effect of~     cilostazol like vasodilation, lipid metabolism, and cytokine production. But there were few~     clinical studies that support these effects of cilostazol. The purpose of this study is to~     evaluate the vasodilatory and anti-inflammatory effect of cilostazol presented by PWV and~     plasma adipocytokines.~   "
227923|NCT00573937|"~     The purpose of this study is to compare methadone with morphine in the management of moderate~     to severe cancer pain.~   "
227924|NCT00573924|"~     Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an~     acid-blocking drug (called a proton pump inhibitor [PPI]) either by mouth every 3 hours for~     24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach~     will be used to determine intragastric pH (a measure of the acid production in the stomach)~     at baseline and during the 24 hours of therapy. The purpose of the study is to determine if~     the continuous intravenous administration of the drug provides better reduction of acid in~     the stomach than the oral administration.~   "
227925|NCT00573911|"~     Patients with Barrett's Esophagus are known to have excessive distal esophageal acid exposure~     comparable to patients with erosive esophagitis. A significant proportion of patients with BE~     who are not symptomatic on treatment continue to have persistent acid reflux. High dose~     esomeprazole is able to control acid reflux in patients with BE. The effect of acid reflux on~     Barrett's esophagus stroma is currently unknown.~      It is our hypothesis that stromal fibroblast activation in Barrett's esophagus is influenced~     by acid reflux. The specific aim of this proposal will be: To assess the association between~     acid reflux and subepithelial fibroblasts in Barrett's esophagus.~   "
227926|NCT00573898|"~     This will be a prospective, multicenter, open-labeled, non-comparative pharmacokinetic study~     conducted in 10 critically ill, anuric patients receiving CVVHDF. Enrollment will take place~     at 3-5 clinical sites in the United States. A study coordinator at each site will be~     identified and institutional specific processes (e.g., pharmacy records, etc.) will be~     utilized to identify patients. Full evaluation of inclusion and exclusion criteria will be~     conducted by each site's coordinator within 48 hours of initiation of daptomycin therapy.~     Subjects receiving daptomycin 6mg/kg (total body weight) once daily for a~     suspected/documented infection, as deemed necessary by the treating clinician will be~     screened for inclusion in the current study. Dialysate, ultrafiltrate, and blood flow rate~     utilized during the CVVHDF procedure will be determined by clinicians at discretion to~     optimize stability of patients.~      Daptomycin samples will be obtained around the third dose in an attempt to achieve~     approximate steady-state concentrations. Pre- and post-filter blood samples will be collected~     simultaneously with dialysate and ultrafiltrate specimens at multiple time points. Protein~     binding will be assessed by filtration of the serum samples at the peak drug concentration~     time points.~   "
227927|NCT00573885|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Green tea~     extract may keep cancer from forming.~      PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in~     former and current heavy smokers with abnormal sputum.~   "
227928|NCT00573872|"~     Phase I of the study (motion and quality assurance [QA] study) is being used to determine~     intrafraction target motion and define quality assurance procedures for single fraction~     spinal radiosurgery. The Phase II portion of the study is being used to estimate the~     palliative response (pain or relief of neurologic symptoms) and local control for single~     fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of~     spinal radiosurgery.~   "
228059|NCT00572104|"~     This study will compare the ability of two types of long term (12 months) weight-bearing~     exercise treatments (1. high-intensity jumping and 2. weight lifting) to increase bone mass~     of the total body, spine and hip in physically active men with osteopenia.~   "
227929|NCT00573859|"~     Whereas the smoking prevalence rates in the general population are declining, rates among~     people diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to be~     elevated. Smoking may be a form of self-medication in people with ADHD, which has specific~     reinforcing mechanisms such as improvement of ADHD core symptoms, enhancement of moods and~     arousal, or a combination of both. In addition, the reinforcing effects of smoking may be~     potentiated by stimulant medication.~      The study examined the reinforcing effects of ad libitum smoking with and without ADHD~     medication in adult smokers with clinically diagnosed ADHD. Participants were adults with~     ADHD. The effects of two day of ADHD medication compared to two days on placebo for were~     studied on nicotine intake (i.e., cotinine levels). In addition, task performance on the~     Continuous Performance Task and nicotine withdrawal symptoms were examined in response to~     ADHD medication + smoking a cigarette versus ADHD medication + abstinence versus placebo~     medication + smoking versus placebo medication + abstinence.~      The study identified the reinforcing mechanisms of smoking in interaction with ADHD~     medication. The findings will contribute to a better understanding of nicotine addiction and~     facilitate the development of targeted smoking cessation and prevention programs for~     individuals with ADHD and other people with deficiencies in impulse control and excessive~     risk taking.~   "
227930|NCT00573846|"~     This is a retrospective, case control study of inflammatory bowel disease. This study will~     analyze the phenotypic characteristics of inflammatory bowel disease in the Southeast Asian~     population and will help describe clinical characteristics and serologic profiles in~     Southeast Asians with inflammatory bowel disease, comparing the phenotype differences to~     historical Caucasian controls. The data from this study will help identify the phenotype~     characteristics of different ethnic groups and study the epidemiological patterns of the~     disease.~   "
227931|NCT00573833|"~     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near~     a tumor to kill tumor cells.~      PURPOSE: This clinical trial is studying the side effects and how well internal radiation~     therapy works in treating patients with prostate cancer.~   "
227932|NCT00573820|"~     A study to determine the use of far infrared radiation for the treatment of prostate cancer.~   "
227933|NCT00573807|"~     A preliminary study to determine the use of far infrared radiation for the treatment of back~     pain~   "
227934|NCT00573794|"~     To assess the long-term safety and maintenance of response of adalimumab in subjects with~     ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or~     M06-827 (NCT00408629).~   "
227935|NCT00573781|"~     Professor Matti Uusitupa, University of Kuopio, Department of Clinical Nutrition (www.uku.fi)~     Docent Matej Oresic, VTT (www.vtt.fi) Ursula Schwab, PhD, Docent, Marjukka Kolehmainen, PhD,~     Docent, Leena Pulkkinen, PhD, Docent, David Laaksonen, MD, PhD, MPH, Docent, Kaisa Poutanen,~     DSc (Tech), Research Professor~      ABSTRACT~      The metabolic syndrome (MS) and type 2 diabetes (T2DM) are the most important health problems~     worldwide. In Finland the prevalence of T2DM is 12-15% among middle-aged people. The~     prevalence of less marked disturbances in glucose metabolism and MS is 30-40%. Because MS and~     T2DM are important risk factors for cardiovascular diseases (CVD), the leading cause of death~     in western countries, all efforts to reverse the epidemic increase in the incidence of MS and~     T2DM are warranted. The investigators have focused for years on the prevention and~     non-pharmacological treatment of T2DM and its complications including studies on genetic~     regulation of glucose and lipid metabolism after dietary modifications. In the investigators'~     recent projects, the investigators have studied the effects of long-term dietary~     interventions on gene expression profiles of fat tissue in subjects who are at risk of T2DM.~     The ultimate goal of these projects has been to identify genes and gene clusters and their~     biological pathways that respond to dietary modification and modulate glucose and lipid~     metabolism, and to develop dietary strategies for prevention of T2DM. The main goal of this~     project is to find nutrition related early biomarkers for progression of MS to T2DM by using~     modern technologies of systems biology (transcriptomics, metabolomics) of carefully conducted~     dietary interventions involving subjects with MS. The data will be analysed by using~     bioinformatics. The investigators reflect these new data to well-known risk factors for T2DM~     and CVD, e.g., insulin sensitivity, insulin secretion, serum lipids and inflammatory factors~     among others. In addition to interventions conducted earlier, a new intervention with a whole~     grain-berry-fish diet and a whole grain diet compared to a control diet with refined foods~     will be performed. The aim is to increase the investigators' understanding on the synergistic~     effects of these foods, because the investigators' previous interventions have shown that~     these individual foods have beneficial effects on glucose and lipid metabolism. On the~     contrary, diets with refined foods may be harmful in long-term due to its high insulin~     response, which may through chronic stress lead to both insulin resistance and beta-cell~     damage.~      The significance of this project is to increase understanding of the pathophysiology of MS,~     T2DM and CVD in physiological, cellular and genetic systems, which may lead to more effective~     and individualised strategies for treatment and prevention, and better identification of~     high-risk individuals responsive to specific dietary modifications. Increasing knowledge of~     dietary factors involved in the progression of MS to T2DM and CVD offers new opportunities to~     individually tailored diets in the management and prevention of these disorders. The results~     will also be beneficial for the food industry in developing new functional foods. These~     results and actions may help delay or even stop the epidemic of MS and T2DM and their~     negative effect on public health currently seen in Finland and worldwide.~   "
227936|NCT00573768|"~     This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment~     of acute ankle sprain.~   "
227937|NCT00573755|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor~     and by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of~     breast cancer cells. Aromatase inhibition therapy using letrozole, anastrozole, or exemestane~     may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet~     known whether sorafenib is more effective than a placebo when given together with letrozole,~     anastrozole, or exemestane in treating metastatic breast cancer.~      PURPOSE: This randomized phase II trial is studying how well sorafenib works compared with a~     placebo when given together with letrozole, anastrozole, or exemestane in treating~     postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive~     metastatic breast cancer.~   "
227938|NCT00573742|"~     The purpose of this study is to observe treatment with candesartan cilexetil 16mg for 8~     weeks, in uncontrolled hypertensive patients, in improvement of achieving of treatment goals~     and impact on blood pressure level in patients with uncontrolled hypertension treated with~     candesartan cilexetil.~   "
227939|NCT00573729|"~     Port wine stain are a congenital, progressive vascular malformation of human skin. The pulsed~     dye laser is approved by the Food and Drug Administration for the treatment of choice.~     However, the degree of port wine stain blanching seen following pulsed dye laser treatment~     remains variable and unpredictable. If the ultimate standard required is complete lesion~     blanching, the average success rate is below 10%, even after undergoing numerous pulsed dye~     laser treatments. Moreover, less than 50% of patients achieve 50% fading of their Port wine~     stain in response to pulsed dye laser therapy.~   "
227940|NCT00573716|"~     This study examines if the use of antipsychotic medications might contribute to an~     interruption in bone mineral development and/or a reduction in bone mineral content in~     adolescents.~   "
227941|NCT00573703|"~     Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress~     incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety,~     also in comparison with similar procedures have been demonstrated. The benefits of the sling-~     adopting procedures in comparison to laparoscopic Burch colposuspension, which has been~     considered as the gold standard treatment, have been showed. But these comparisons did not~     included the TOT procedure in the experimental arms. Based on this considerations the aim of~     this trial will be to compare TOT and laparoscopic Burch colposuspension in women with~     urinary stress incontinence.~   "
227942|NCT00573690|"~     RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by~     blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, etoposide,~     and carboplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving sorafenib together with cisplatin and~     etoposide or carboplatin and pemetrexed may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when~     given together with cisplatin and etoposide or carboplatin and pemetrexed in treating~     patients with metastatic solid tumors.~   "
227943|NCT00573664|"~     The purpose of this study is to determine whether a single dose of gabapentin, given before~     cesarean section, will reduce pain in the initial 24 hours after surgery. Gabapentin has been~     very effective at treating pain after knee and hip operations, hysterectomies, and many other~     types of surgeries. We believe that it may be effective for treating pain after cesarean~     sections, but it has never been studied for this purpose.~   "
228060|NCT00572091|"~     Improvement in heart failure with moderate to severe mitral regurgitation using a~     percutaneously delivered implanted device~   "
227944|NCT00573651|"~     The purpose of this research study is to see if patients with juvenile idiopathic arthritis~     or seronegative arthritis (and related conditions) mount protective immune responses to the~     human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for~     any increase in disease activity following receipt of the vaccine.~   "
227945|NCT00573638|"~     The study hypothesis is that the Xal-Ease with increase patient compliance with XALATAN~   "
227946|NCT00573612|"~     Fibromyalgia (FMS), defined as the presence of both chronic widespread pain and the finding~     of 11/18 tender points on examination, affects 2% of the general population. Drug therapy for~     FMS is largely symptomatic as there is not yet a complete understanding of the pathogenesis~     of the disease. In the past 17 years, supervised aerobic exercise has emerged as an important~     treatment modality to improve pain, aerobic capacity, function, and well-being. Individuals~     who are able to adhere to exercise almost always maintain the symptomatic benefits of~     exercise. Unfortunately, the rate of exercise adherence six months after the completion of a~     well-structured supervised exercise program is disappointingly low. Furthermore, although the~     efficacy of supervised aerobic exercise in the research setting is well documented, the~     applicability of such intervention in the clinic setting is doubtful. Therefore, we propose~     to conduct the Research to Encourage Exercise for Fibromyalgia (REEF), a randomized~     attention-controlled trial whose primary aim is to evaluate the efficacy of~     telephone-delivered motivational interviewing (MI) to encourage exercise, in improving~     exercise adherence and self-report physical function (co-primary outcome measures) for FMS~     patients. REEF will enroll 200 FMS patients, randomizing them to either the MI group or the~     attention-control (AC) group. Participants from each group will receive a total of 6~     telephone calls within a 12-week period. Prior to the phone calls, participants from both~     groups will receive an individualized exercise prescription and 2 supervised exercise~     training sessions to get them started on an exercise program. All subjects will undergo~     comprehensive outcome assessment at baseline, week 12, week 24, and week 36. The secondary~     aim of this proposal is to determine the mediators between MI and improvement in self-report~     physical function. The proposed research is significant because our focus is the promotion of~     adherence to an exercise program, of adequate intensity, in order to maximize functioning and~     well-being for patients with FMS. The use of a predominantly home-based exercise program and~     telephone-delivered MI by a trained licensed practice nurse (LPN) could potentially make the~     proposed intervention more accessible to the greater majority of FMS patients. Furthermore,~     if proven efficacious, MI could readily be applied to other chronically painful conditions~     (e.g. chronic back pain).~   "
227947|NCT00573599|"~     ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR~     imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is~     improvement in pain scales between the groups.~   "
227948|NCT00573586|"~     This is an investigational study on the use of high intensity focused ultrasound (HIFU) in~     the management of localized prostate cancer (T1c/T2a) as a primary non-comparative study.~      High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that~     uses intersecting, precision focused ultrasound waves to raise the temperature of the target~     to) 80-90 degrees C in 2-3 seconds, destroying the targeted tissues (prostate cancer). The~     tissue targeting is highly precise, minimizing collateral damage.~      The overall hypothesis is that HIFU with Sonablate can safely, effectively and selectively~     ablate prostate cancer tissue, resulting in complete tissue necrosis, in patients diagnosed~     with localized T1c/T2a prostate cancer, with minimal morbidity.~      The specific hypothesis is that the Sonablate has the ability to:~        -  Completely destroy prostate cancer tissue, without causing damage to the intervening~          tissue, with a drop in PSA levels to <0.5ng/ml.~        -  Result in negative biopsies for evidence of viable malignant cells after the treatment~          (12 months if Nadir is not reached or PSA rises from Nadir)~        -  Safely treat localized prostate cancer patients, with minimal and acceptable adverse~          effects~   "
227949|NCT00573573|"~     A study to determine the possibility of using far infrared radiation to treat~     Hyperparathyroidism.~   "
227950|NCT00573560|"~     The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the~     malfunctioning portion of the left ventricle in patients with symptoms of heart failure due~     to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it~     is hypothesized that the left ventricle will pump more effectively.~   "
227951|NCT00573547|"~     The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in~     depression in patients requiring kidney dialysis.~   "
227952|NCT00573534|"~     This is an open label pilot study to obtain information on the best way to study young~     adolescents with Attention Deficit Hyperactivity Disorder (ADHD)who may also be at risk of~     developing substance abuse, in part because of their ADHD. The plan is to recruit older~     children/young adolescents (age 11-15) who have ADHD and also have an older sibling with~     substance abuse. The treatment for ADHD in the 11-15 year old will be Vyvanse, a novel~     preparation of dextroamphetamine in which the molecule is inactivated and only becomes~     activated when it is digested. This preparation is felt to be safer from diversion while at~     the same time providing treatment for the younger siblings in which a bad outcome has already~     occurred in the family, namely the older sibling's substance abuse. As mentioned, this is an~     open-label study, a feasibility study to see if we can use this approach to study and treat~     high risk youth before they develop substance abuse.~   "
227953|NCT00573521|"~     This research will be conducted to determine whether risk factors exist for~     piperacillin/tazobactam resistance in ESBL organisms.~   "
227954|NCT00573508|"~     Evaluate the effect of VESIcare® on symptom bother for subjects with OAB~   "
227955|NCT00573495|"~     This is a study on how to activate the immune system with a vaccine. The vaccine is made up~     of two proteins found in breast cancer: telomerase and survivin. The vaccine is given in~     combination with other drugs that may also have an effect on the immune system and attack the~     cancer.~      The goals of the study are:~        1. to test the safety of the combination of agents~        2. to find out what effects the treatment has on advanced breast cancer~   "
227956|NCT00573482|"~     The dramatic rise in overweight and obesity during the past several decades can be explained~     by environmental changes that foster increased energy intake and decreased energy~     expenditure. There are several reasons to suggest that the most effective approach to weight~     gain prevention is the incorporate reduced-fat eating into an overall strategy of lowering~     the energy density of the diet. Our energy density manipulations will be designed to reduce~     both the fat content and the caloric density of foods served at a cafeteria, which serves as~     the food environment for hospital employees.~   "
227957|NCT00573469|"~     The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in~     Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of~     Crohn's disease and quality of life.~   "
227958|NCT00573456|"~     A study to determine the use of far infrared (FIR) radiation for treatment of diabetes.~   "
228349|NCT00568178|"~     The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric~     patients.~   "
227959|NCT00573443|"~     Objectives of the study are to evaluate the safety, tolerability, and efficacy of two~     different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide~     and 10 mg of quinidine sulfate [AVP-923-30] or 20 mg of dextromethorphan hydrobromide and 10~     mg of quinidine sulfate [AVP-923-20]) when compared to placebo, for the treatment of PBA in a~     population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS)~     over a 12-week period. An additional objective is to determine the pharmacokinetic parameters~     of the two different doses of AVP-923 in a subset of the study population.~      Pseudobulbar Affect (PBA) is a condition characterized by involuntary, sudden and frequent~     episodes of laughing and/or crying out of proportion or incongruous to the underlying emotion~     of happiness or sadness Other terms used to describe this condition include emotional~     lability, emotionalism, emotional incontinence, emotional discontrol, excessive emotionalism,~     and pathological laughing and crying. The outbursts can occur spontaneously or in response to~     provocative stimuli such as questions or events.~      A body of evidence suggests that PBA can be modulated through pharmacologic intervention.~      Dextromethorphan (DM) is a low-affinity uncompetitive antagonist of the N-Methyl-D-aspartate~     (NMDA) receptor, reducing the level of excitatory activity. DM also acts at the~     phencyclidine-binding site, which is part of the NMDA receptor complex. DM is a sigma~     receptor agonist, suppressing the release of excitatory neurotransmitters.~      Quinidine (Q) is a known potent inhibitor of cytochrome P450 2D6 (CYP2D6), that decreases the~     metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this~     drug.~   "
227960|NCT00573430|"~     To determine the effective dose of candesartan cilexetil for reduction of urinary protein~     excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline~     urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in~     urinary protein/creatinine ratio from baseline to the end of 28-week treatment~   "
227961|NCT00573417|"~     This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating~     dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of~     clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be~     initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4~     weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based~     upon persistence of sedation versus emergence of side effects.~   "
227962|NCT00573404|"~     RATIONALE: Imatinib mesylate and sunitinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate~     given together with sunitinib in treating patients with gastrointestinal stromal tumors.~   "
227963|NCT00573391|"~     This study is being done to find out if the combination of VelcadeTM with melphalan and~     dexamethasone (VMD) will be as effective, or even more effective as it is in combination with~     thalidomide and dexamethasone (VTD).~   "
227964|NCT00573378|"~     To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have~     achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be~     treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b~     (PEG-IFN-a2b, [IFN]) for 2 years, subsequently have their therapy discontinued, and then~     maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1~     year after discontinuation of the TKI and IFN will be the measurement of this objective.~   "
227965|NCT00573365|"~     Radiation dermatitis is a common side-effect of radiation therapy in cancer patients who~     frequently can experience redness, pain, crusting, and even ulceration of the skin causing~     suffering and treatment interruption. A recent retrospective study by DeLand demonstrated~     that administering light emitting diode (LED) photomodulation after each radiation treatment~     for breast cancer decreased radiation dermatitis in a majority of patients. LED~     photomodulation is a process by which specific sequences of light are used to regulate or~     manipulate cell activity without causing heat or damage to the skin. Each LED treatment is~     painless and is completed in usually less than one minute. LED photomodulation may reduce the~     suffering associated with radiation treatments, improve cosmetic outcome in radiation fields,~     and eliminate breaks in radiation treatments which may be required because of severe~     ulcerating reactions.~      This study will attempt to replicate the findings of Dr. DeLand's study by randomly assigning~     at least 40 breast cancer patients to either a treatment group or to a control group. The~     treatment group will receive LED photomodulation treatments before and after each radiation~     treatment with the Gentlewaves Select™ handheld high energy 590nm LED array using specific~     sequences of pulses used in other studies; the treatment group will also receive 7 additional~     treatments over 2 weeks after their radiation treatment course is completed. The control~     group will receive no LED treatment but will use the exact same skin care regimen as the~     treatment group. In addition to weekly evaluation and grading of skin reactions, subjects~     will be photographed under standardized conditions weekly and then photographs will be~     evaluated and graded by blinded dermatologists.~   "
227966|NCT00573352|"~     A study to evaluate the possibility of using far infrared radiation to manage pain due to~     osteoarthritis.~   "
227967|NCT00573339|"~     The purpose of this research is to understand how to apply cardiac magnetic resonance imaging~     (CMR) to women with small artery heart disease by looking at the CMRs of women without heart~     disease. The investigators will study 40 women with no heart disease to learn more about the~     usefulness of CMR.~      Women suffer more than men from this disorder of the small vessels compared to the large~     vessels. This results in delays in diagnosis, missed opportunities for treatment, and likely~     contributes to the increased death rate from heart disease in women compared to men. Current~     testing for small vessel disease is invasive and not performed routinely and women are often~     not initiated on appropriate lifesaving treatment. New imaging and noninvasive technology~     exists that may improve this situation. Imaging techniques such as cardiac magnetic resonance~     imaging (CMR) can now show the inner layers of the heart where the small vessel abnormality~     and myocardial ischemia exist. These techniques, while promising, have not been tested to~     determine if they can be used to diagnose and treat the small vessel coronary heart disease~     condition. They also have not been studied extensively in women without heart disease.~      Gadolinium, the contrast agent that will be given Intravenously to all study participants~     during the cardiac MRI procedure, is contraindicated to patients with renal impairment. Even~     though it will only be given once to each of our patients, the investigators still wanted to~     establish the fact that these study participants have normal or good renal functioning by~     doing BUN and Creatinine blood tests prior to the administration of this contrast agent to~     their system. By adding these lab tests, the investigators will be more cautious to the~     well-being and safety of the study participants.~      The investigators will be recruiting women aged 35-65 years with no known heart disease or~     heart disease risk factors like high blood pressure or high cholesterol. Participants will~     discuss the cardiac magnetic resonance procedure with a research doctor and if they agree,~     will fill out questionnaires related to their health, have blood draw and then undergo the~     CMR procedure. This can be completed in 1 or 2 visits. No follow up is needed.~   "
227969|NCT00573313|"~     Prior studies in animal models have established that the pathogenesis of alcoholic liver~     disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic~     methionine metabolism. The hypothesis of the clinical study was that provision of the~     methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine~     metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to~     determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by~     comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics~     without liver disease, and normal healthy subjects, and b) to determine the treatment effects~     of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical~     features of liver injury in ALD patients.~   "
227970|NCT00573300|"~     In this pilot study, the investigators propose to characterize the pattern of activation of~     the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with~     schizophrenia. To do this, the investigators will measure the gene expression of several~     major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan~     to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase~     chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or~     cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization~     of the activation of this metabolic pathway.~   "
227971|NCT00573287|"~     Many individuals with schizophrenia abuse cannabis at the onset of their illness, portending~     a poorer course of illness and poorer treatment response. Preliminary evidence suggests that~     clozapine may uniquely reduce substance use in patients with schizophrenia. The purpose of~     this study is to establish an effective methodology for studying early treatment with~     clozapine in patients with co-occurring schizophrenia and cannabis use disorder, while~     generating pilot data comparing clozapine vs. risperidone on substance use, psychiatric~     symptoms, side effects, and treatment discontinuation.~   "
227972|NCT00573274|"~     Pregnant patients having a cesarean section (CS) under spinal anesthesia experience a variety~     of hemodynamic changes, such as hypotension due to decreases in cardiac output (CO), stroke~     volume (SV) and/or systemic vascular resistance (SVR). Measurement of these hemodynamic~     parameters classically requires insertion of a pulmonary artery catheter (PAC) into the~     heart. However, this invasive method carries significant complications and its use is now~     reserved for the more critically ill patients. We hypothesize that the Physioflow Impedance~     device can be used as a reliable non-invasive monitor to measure hemodynamic parameters~     during elective CS under spinal anesthesia.~   "
227973|NCT00573261|"~     This study is designed to examine how pregabalin affects parameters of autonomic nerve~     regulation in correlation with change in pain, anxiety, and depressive symptoms in patients~     with diabetic neuropathy.~   "
227974|NCT00573248|"~     Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsivity,~     and hyperactivity that are frequently treated with stimulant medications such as Ritalin.~     Many people with ADHD smoke. The smoking prevalence rates are estimated to be 40% in adults~     with ADHD compared to 20% in the general population. People with ADHD have also more~     difficulty to quit smoking. Only 29% of smokers with ADHD quit smoking compared to 48.5% of~     smokers in the general population. Nicotine is a stimulant, which may have properties similar~     to stimulant medications (e.g., Ritalin) used to treat ADHD. Nicotine may increase attention~     and reduce hyperactivity and impulsivity and, thus, may regulate behavior in individuals with~     ADHD. Alleviating the symptoms of ADHD and increasing cardiovascular activity through smoking~     may mimic the effects of stimulant medications and can be a form of self-medication.~      The major objective of the study was to examine the effects of nicotine on ADHD symptoms,~     moods, and cardiovascular activity. The study investigated the effects of nicotine patches on~     behavioral regulation in adult smokers and nonsmokers with ADHD. Smokers and nonsmokers with~     ADHD participated in two conditions: (1) nicotine patch and (2) placebo patch. During each~     condition, symptoms, moods, and side effects were assessed for 2 days during waking hours. An~     electronic handheld diary, programmed to prompt the participant twice per hour, recorded ADHD~     symptoms (e.g., difficulty concentrating, impulsivity, etc.), negative moods (e.g., anger,~     stress), and nicotine side effects (nausea, dizziness). Heart rate and blood pressure were~     recorded with lightweight ambulatory monitors to indicate cardiovascular activity. Results~     provided information about the effects of nicotine patches on behavioral regulation in adult~     smokers and nonsmokers with ADHD.~      The inclusion of nonsmokers was important to clarify whether the effects of nicotine on~     smokers was due to smoking withdrawal. The findings help explain the increased smoking~     prevalence rates and reduced quit rates associated with ADHD. Knowledge about nicotine's~     effects on behavioral regulation can help to develop successful smoking cessation programs~     for individuals with ADHD. The findings on cardiovascular activity may help determine the~     potential risk for cardiovascular disease in smokers and nonsmokers with ADHD. The study~     contributed to understanding nicotine's effects on behavioral regulation in a highly~     vulnerable population such as people with ADHD.~   "
227975|NCT00573235|"~     The purpose of this study is to review patients with E. coli infections at the University of~     Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these~     infections have arisen in the community rather than in hospitals or nursing homes.~   "
227976|NCT00573222|"~     This is a 3-month non-interventional, observational study on patients with moderate and~     severe asthma.~   "
227977|NCT00573209|"~     A preliminary study to determine the possibility of using far infrared (FIR) radiation to~     treat impotency.~   "
227978|NCT00573196|"~     A preliminary study to determine the possibility of using far infrared radiation for the~     treatment of the Bipolar Condition~   "
227979|NCT00573183|"~     The purpose of this study is to determine whether a combined group and individual 12-Step~     facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12),~     improves substance -related outcomes.~   "
227980|NCT00573170|"~     Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled,~     Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus~     Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when~     administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)~   "
227981|NCT00573157|"~     The purpose of this study is to learn whether atacicept treatment leads to improvement in~     kidney function in subjects with active lupus nephritis in combination with mycophenolate~     mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International;~     operational oversight was provided by ZymoGenetics.~   "
227982|NCT00573144|"~     The purpose of this study is to determine the efficacy of intravenous human beta natriuretic~     peptide (BNP, Nesiritide) as compared to placebo to prevent adverse post acute myocardial~     infarction left ventricular remodeling.~   "
227983|NCT00573131|"~     OncoGel is a new experimental drug delivery system that allows the slow continuous release of~     paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period~     of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.~      The protocol is directed towards evaluating the efficacy and safety of paclitaxel delivered~     as a local, intralesional treatment when used in combination with chemotherapy (cisplatin and~     5-FU) and radiation therapy before surgery.~   "
230410|NCT00540644|"~     The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and~     prednisone (RCP) in patients with newly diagnosed multiple myeloma.~   "
227984|NCT00573118|"~     Congenital and acquired thrombophilia were identified as risk factors for thrombosis in~     systemic vessels.Thrombophilias have also been recently found to be associated with~     preeclampsia, intrauterine fetal growth restriction (IUGR), placental abruption, intrauterine~     fetal death (IUFD) and repeated pregnancy loss.These severe pregnancy complications are~     thought to result from thrombotic events occurring in the uteroplacental circulation.~     Accumulating data have established an association between elevated plasma activity of factor~     VIII and thrombosis although the mechanism is still not defined and elevated factor VIII~     activity is now regarded as being equivalent to thrombophilia.~      We intend to investigatthe association between factor VIII levels and severe pregnancy~     complications which are considered to result from placental vascular pathology, i.e.,~     preeclampsia, IUGR, placental abruption and IUFD. We hypothezise that the prevalence of~     elevated factor 8 will be higher among women with pregnancy complications compared to~     controls.~   "
227985|NCT00573105|"~     1. General~           - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes~          before surgery~        2. Laparoscopic surgery~             -  at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)~             -  with or without anchoring transparietal sutures or double crown technique~   "
227986|NCT00573092|"~     High blood pressure is one of the most common health problems in the United States. There are~     many drug treatment options for high blood pressure, but these medications are not always~     effective. People with treated high blood pressure can still suffer from other serious~     cardiovascular health problems, including heart attack, sudden death, or stroke. Genetic~     variations may cause some people to be more susceptible to these cardiovascular outcomes~     despite treatment. This study will identify new gene regions that may influence the~     effectiveness of high blood pressure drugs in preventing the above mentioned cardiovascular~     conditions.~   "
227987|NCT00573079|"~     Our first Aim is to describe how common a sudden decrease in renal function happens in~     premature infants in a neonatal intensive care unit. We also want to see how a sudden loss of~     renal function affects survival. Finally, we will explore non-invasive markers to identify a~     sudden decrease in renal function from urinary samples.~   "
227988|NCT00573066|"~     This study is being conducted to determine what dexmedetomidine does to the body and in turn,~     what how the body handles the medication. This medication, for the purpose of this trial, is~     used as a short-term sedative for infants who are immediately post-operative from cardiac~     surgery and have a breathing tube and are breathing with the assistance of a mechanical~     ventilator or breathing machine.~   "
227989|NCT00573053|"~     To determine whether targeting lower arterial oxygen saturations from the day of birth alters~     the early (first 3 months) postnatal development of the control of ventilation and the~     hypercapnic and hyperoxic responses in very preterm infants.~   "
227990|NCT00573040|"~     Our group has shown in a modeling study that increasing the radiation dose to pre-specified~     normal tissue dose constrains could lead to increased TCP with the same NTCP. In a subsequent~     phase I trial, the investigators showed the safety of this approach. Here, the investigators~     want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC,~     who are selected for radical radiotherapy~   "
227991|NCT00573027|"~     Women suffer disproportionately than men from Cardiac Syndrome X ( chest pain in the absence~     of flow limiting coronary artery stenosis). Coronary microvascular disease is hypothesized to~     mediate chest pain in this syndrome. This disorder of the small heart vessels (arterioles)~     compared to the large vessels (arteries) is not diagnosed during routine heart~     catheterization. This results in delays in diagnosis, missed opportunities for treatment, and~     likely contributes to the increased death rate from coronary heart disease in women compared~     to men.~      Current testing for small vessel disease is performed in the cardiac catheterization~     laboratory using specialized testing and is not performed routinely. Accordingly, women with~     this condition are either falsely reassured, or misdiagnosed as another non-cardiac~     condition. Unnecessary healthcare costs related to re-hospitalization and repeat angiography~     are incurred, while women are often not initiated on appropriate lifesaving treatment. We and~     others have demonstrated in randomized controlled trials that therapies that target the~     endothelium, e.g. statins, ACE inhibitors, and exercise are effective in this condition.~      Majority of women with Cardiac Syndorme X go undiagnosed. Recent studies have shown~     significant increased health care costs, morbidity and mortality related to this disease. It~     is becoming more important to further characterize this group of patients and we hope to do~     that with our study.~   "
227992|NCT00573014|"~     The optimal method of clearing the cervical spine in obtunded trauma patients is unclear.~     Computed tomography (CT) identifies most injuries but may miss ligamentous injuries. Magnetic~     resonance (MR) imaging has been widely used to exclude ligamentous injuries. We postulate~     that with the new generation of CT scanners, MR imaging is not needed to rule out significant~     injuries. Our protocol for clearing the cervical spine in obtunded trauma patients depends on~     CT alone. We are prospectively following these patients and performing a clinical examination~     when they are awake to show this is a safe approach.~   "
227993|NCT00573001|"~     The goal of this trial is to demonstrate that new treatments are as effective as a reference~     triple-agent regimen in driving plasma viral load below the detection limit early during~     treatment (16 weeks). These simplified treatments involve fewer tablets and intakes,~     fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor~     and tenofovir.~   "
228017|NCT00572689|"~     This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar~     in non-pregnant patients with type II diabetes, works in pregnant women. To do this, we will~     study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly~     your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the~     body; specifically, how effectively exenatide helps your pancreas secrete insulin and how~     well it controls blood sugar after a meal). There are only two main drug therapies (insulin~     injections and glyburide pills) currently used for gestational diabetes and not all women~     achieve good enough blood sugar control without side effects. Therefore, we hope to find out~     if exenatide might also be helpful in gestational diabetes.~   "
228061|NCT00572078|"~     The purpose of this study is to evaluate the safety and tolerability and describe the maximum~     tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with~     bevacizumab and paclitaxel for patients with advanced solid tumors.~   "
227994|NCT00572988|"~     The major purpose of this experimental study is to test the effects of the symptom management~     home care nursing intervention (SMHCNI) on recovery outcomes of elderly CABG patients, using~     a randomized, two group (n=284) repeated measures design with measurements at discharge, at 3~     and 6 weeks, and 3 and 6 months postoperatively. One group will receive the intervention and~     routine care (RC) and the other group will receive RC only. The major aim will be to~     determine if the intervention group will demonstrate: better physiological functioning~     (decreased symptom interference on physical functioning; better scores on the SF36 subscales:~     physical, role-physical and vitality, and increased activity and exercise energy~     expenditure); better psychosocial functioning (decreased symptom interference on enjoyment of~     life; and better SF36 subscales; role-emotional, social, mental, and vitality); and fewer~     postoperative problems (e.g. infections, fluid in lungs, heart rate rhythm problems).~     Additional outcomes for secondary aims are: lower levels of health care utilization (HCU)~     (i.e., fewer number of visits to health care providers, fewer number of emergency department~     visits, fewer number of home health visits, fewer rehospitalizations); and higher patient~     satisfaction (with level of functioning and care received). In addition this study will~     examine the potential effects of mediating (evaluation of symptoms, and perceived~     self-efficacy), and moderating variables (participation in cardiac rehabilitation) with the~     intervention on outcomes identified.~   "
227995|NCT00572975|"~     *The purpose of this study is to develop a more accurate, reliable, specific and more~     acceptable alternative clinical test to the 72-hour stool and diet collection for quantifying~     fat malabsorption in people with CF and pancreatic insufficiency.~   "
227996|NCT00572962|"~     1. General: antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30~          minutes before surgery~        2. Laparoscopic surgery~             -  at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)~             -  with or without anchoring transparietal sutures or double crown technique~   "
227997|NCT00572949|"~     The purpose of this research study is to evaluate a better way of diagnosing heart artery~     disease, heart attack and damage to the heart muscle early on. Currently, it often takes~     several hours after admission before lab tests will show that there has been any damage to~     the heart muscle. Although the standard electrocardiogram is quick and non-painful it may~     miss many cases of significant coronary heart disease. The investigators are proposing that a~     new entirely non-contact tool, the Magnetocardiograph (MCG), with high accuracy is able to~     predict the presence of significant coronary heart disease early on before other studies~     become positive. The investigators hope by this that the investigators can develop an~     algorithm for better triage and management of patients with chest pain.~      This research study is designed to test the effectiveness of the investigational use of the~     Magnetocardiograph (MCG) that has been approved by the U.S Food and Drug Administration~     (FDA). While the MCG used in the study is FDA-approved as a tool for the non-contact~     measurement and display of the magnetic fields of the heart generated by the electrical~     currents, it is not yet approved for the specific diagnosis of heart artery disease~     (ischemia).~   "
227998|NCT00572936|"~     This study is designed to identify physiological, pharmacological and pathological circadian~     fluctuations in aqueous humor inflow and outflow, systemic blood pressure and ocular blood~     flow in humans.~   "
227999|NCT00572923|"~     Our group has shown that the omission of elective nodal irradiation on the basis of CT scans~     in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the~     ipsilateral supraclavicular area. We have previously also shown that selective mediastinal~     nodal radiation on basis of FDG-PET scans in NSCLC is safe and reduces the radiation fields~     and hence toxicity. As the accuracy of FDG-PET scans is also in SCLC higher than CT, we will~     investigate the safety of selective nodal irradiation in LD-SCLC patients treated with~     concurrent chemo-radiation.~   "
228000|NCT00572910|"~     This is a study to evaluate the safety and immunogenicity of V710 with and without Merck~     Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on~     hemodialysis.~   "
228001|NCT00572897|"~     Stem cell transplantation is used to treat may types of diseases. There a 2 types of~     transplants, conventional (very intense) and reduced intensity-non-myeloablative, also called~     mini-transplants.~      This study proposes to use a conditioning regimen for allogeneic transplantation along with a~     reduced intensity transplant. Conditioning regiment is the name for the combination of~     chemotherapy drugs that is given to patients before receiving a transplantation of donor stem~     cells. It is hoped that the regimen designed for this study proves to be less toxic and has~     an equal or better anticancer effect than the regimens that are normally used. The regimen~     being used is a combination of two chemotherapy drugs, fludarabine and melphalan. This~     regimen has been studied in recipients of matched sibling transplants and in recipients of~     alternative donor stem cells in other hematologic malignancies. Those subjects, who receive~     stem cells from an unrelated donor, will also receive and additional drug called ATG or anti~     thymocyte globulin. ATG suppresses the immune system, thus reducing the chances for the~     recipient rejecting the transplant (graft).~      The purpose of this study is to observe if reduced intensity transplants can be used to allow~     engraftment or take of the donor's bone marrow. Studies conducted in the past show this~     type of transplant is much less toxic than traditional bone marrow transplants. Reduced~     intensity transplants may be better tolerated by patients who may experience serious side~     effects from standard (very intense) stem cell transplant.~      The study has been recently amended to follow all subjects for survival.~   "
228002|NCT00572884|"~     Military personnel are exposed to the insecticide permethrin when using the DOD Insect~     Repellent System. A urinary metabolite of permethrin that is in high abundance and is~     relatively stable may be an ideal biomarker of exposure to this pesticide. Monitoring such a~     biomarker can prevent over-exposure. The objectives are to identify the most abundant human~     urinary metabolite following dermal exposure; to utilize this information to develop rapid~     laboratory-based and field portable methods to monitor the degree of an individual's exposure~     to permethrin.~   "
228003|NCT00572871|"~     We are interested in determining if there exist a short-term response in the serum markers~     and hormones that participate in the regulation of bone tissue formation and breakdown to a~     single, high-intensity exercise session of weight lifting (resistance exercise) or jumping~     (plyometrics). We are also interested in determining if the bone marker response to exercise~     is altered by changing the negative energy state caused by the exercise treatment, when~     subjects are given a moderate calorie meal.~   "
228004|NCT00572858|"~     For unexplained reasons, young premenopausal women with heart disease have twice the rate of~     death compared to men of the same age. Animal experiments have shown that stress can reduce~     ovary function in females monkeys due to reductions in brain hormones. This stress and~     reduced brain hormone levels lead to low estrogen levels and can cause menstrual cycles to~     become irregular, leading to reductions in fertility. These monkeys are also more likely to~     develop heart disease. In order, to better understand this relationship the investigators~     would like to study estrogen levels in premenopausal women with heart disease.~      Premenopausal women who have recently undergone a study of their coronary (heart) arteries~     will have their blood hormone levels measured over one menstrual cycle. The investigators~     will correlate the blood hormone levels with coronary angiography results and with other~     markers of heart disease, such as a test that uses noninvasive, painless ultrasound waves to~     study the thickness of the arteries in the neck (carotid arteries). In addition blood~     cholesterol levels, blood sugar levels and other blood tests have been shown to correlate~     with heart disease will be measured.~      Another aim of the study is to evaluate a potential link between environmental stress and~     hormone levels. Each patient will be given multiple questionnaires to evaluate stress,~     anxiety and depression and the investigators will be measuring the stress hormone (cortisol)~     levels in saliva for additional information.~      The results of the study will further explore a possible link between low estrogen levels and~     heart disease in young premenopausal women and help pave the way for larger research studies~     to define better ways of preventing heart disease in these women.~   "
228005|NCT00572845|"~     The purpose of this study is to determine if there is a relationship between spasticity and~     relative changes in Basal Energy Expenditure in persons with spinal cord injury.~   "
228006|NCT00572832|"~     This is a randomized, open label trial of HPV (human papilloma virus) vaccine, comparing an~     on-time administration of the third dose with delayed administration of the third dose. All~     participants would receive the first and second doses according to schedule. They would be~     randomized to either vaccine at 6 months or vaccine at 12 months.~      Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post~     third dose. We hypothesize that the GMTs in the test group (T) are non-inferior to the usual~     timing control group (C):~      H0: δ ≤ −δ0 versus H1: δ > −δ0 where δ = log (GMTT )− log (GMTC) and δ0 is the pre-specified~     non-inferiority margin.~   "
228007|NCT00572819|"~     The aim of this study is to investigate whether 1000 micrograms of self-administered vaginal~     misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical~     ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to~     placebo (lactosum monohydricum) in postmenopausal women.~   "
228008|NCT00572806|"~     This trial is conducted in Europe. The aim of this trial is to investigate if using insulin~     aspart as start therapy will improve the efficacy on daytime blood glucose cycle profile in~     subjects with type 2 diabetes.~   "
228009|NCT00572793|"~     The purpose of this study is to evaluate whether it is possible to detect changes in the~     concentration of PP13 in the blood of pregnant women who may go on to develop the~     complication of preeclampsia later on in the pregnancy, and if these changes can be detected~     early enough to allow early diagnosis and treatment for prevention of these complications and~     reduce their damage. This study will test if the PP13 biomarker during the first trimester of~     pregnancy has the ability to provide assessment of risk for the development of preeclampsia~     that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34~     weeks gestation.~   "
228010|NCT00572780|"~     Specific CT Enteroclysis findings with or without other clinical and laboratory variables,~     can identify Crohn's disease patients who will response to medical therapy versus those who~     will either fail and require surgery or have uncontrolled disease.~   "
228011|NCT00572767|"~     The aim of the study is to evaluate the effect of Dextro-amphetamin added to physiotherapy on~     motor recovery in patients after stroke. The study is a double-blinded placebo-controlled~     randomised controlled trial.~      Patients after a first-ever ischemic stroke will receive Dexamphetamine (10mg) twice per week~     for a duration of five weeks after a baseline phase of two weeks.~      The outcome measure focuses on motor recovery and will be assessed:~        -  one and two weeks before study intervention (baseline phase)~        -  five times during the study intervention~        -  one week after study intervention (follow-up)~        -  once after six and twelve months after start of the study intervention (follow-up).~   "
228012|NCT00572754|"~     The objective of this clinical investigation is to provide the first and preliminary clinical~     data to study the safety and efficacy of male circumcision where the dry circumcision method~     is employed.~   "
228013|NCT00572741|"~     Hypothesis: Many children with autism have impaired methylation and~     antioxidant/detoxification capacity and chronic oxidative stress. A targeted nutritional~     intervention that is designed to correct the metabolic imbalance will normalize their~     metabolic profile and improve measures of autistic behavior.~   "
228014|NCT00572728|"~     This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron~     emission tomography (PET)/computed tomography (CT) works in predicting response in patients~     receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it~     started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may~     help in learning how well chemotherapy works to kill breast cancer cells before surgery and~     help doctors plan the best treatment.~   "
228015|NCT00572715|"~     Our first aim is to describe how common a sudden decrease in renal function happens in~     infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal~     function affects survival. Finally, we will explore non-invasive markers to identify a sudden~     decrease in renal function from urinary samples.~   "
228016|NCT00572702|"~     Head to Head comparison of perioperative complications and secondary the impact of operation~     techniques with or without mesh on patients suffering from pelvic organ prolapse on quality~     of life.~   "
228018|NCT00572663|"~     The main purpose of the study is find whether the addition of N-acetylcysteine (antioxidant)~     to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme~     inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria,~     main prognostic marker of chronic kidney disease progression.~   "
230411|NCT00540631|"~     Multicenter Immunotherapy House Dust Mite Allergoid~   "
228020|NCT00572637|"~     This Phase 1 escalating-dose study is designed to assess, the safety, tolerability,~     pharmacokinetics, and pharmacodynamics of the novel proteasome inhibitor CEP 18770, given~     intravenously as single agent, in patients with advanced, incurable solid tumours or NHL, and~     to identify the recommended dose of CEP 18770 to be used in Phase 2 studies.~   "
228021|NCT00572624|"~     Obesity adversely affects myocardial (muscular heart tissue) metabolism, efficiency, and~     diastolic function. The objective of this study was to determine if weight loss could improve~     obesity-related myocardial metabolism and efficiency and if these improvements were directly~     related to improved diastolic function.~   "
228022|NCT00572611|"~     The primary objective of the study is to define the absorption and excretion kinetics of~     bilastine in man following oral administration, and to investigate the nature of the~     metabolites present in plasma and excreta. The secondary objective of the study is to assess~     the safety and tolerability of bilastine~   "
228023|NCT00572598|"~     Multidrug resistance (MDR) is a cause of treatment failure in many cancer patients. MDR~     refers to a phenotype whereby a tumor is resistant to a large number of natural~     chemotherapeutic drugs. Having prior knowledge of the presence of such resistance would~     decrease morbidity from unsuccessful therapy and allow for the selection of individuals who~     may benefit from co-administration of MDR inhibiting drugs. The Tc-99m labeled single photon~     emitting radiotracers sestamibi and tetrofosmin have shown some predictive value. However,~     positron-emitting (PET) radiotracers, which allow for dynamic, quantitative imaging, hold the~     promise of more accurate and specific identification of MDR tumors.~      Objective:~      To obtain human safety data, to demonstrate imaging feasibility with FPAC, to obtain human~     biodistribution and to obtain preliminary evidence of breast tumor uptake concordance with~     response to therapy.~   "
228024|NCT00572585|"~     This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of~     active, moderate to severe ulcerative colitis in patients who have failed conventional~     therapy using mesalamine or steroids~   "
228025|NCT00572572|"~     Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly~     emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied~     in multiple-day chemotherapy treatment programs. This study will compare the addition of~     aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for~     acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV~     prophylaxis in a double-blind, randomized, crossover study design.~   "
228026|NCT00572559|"~     Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care~     patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus~     (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals.~     Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is~     probably associated with higher mortality. The purpose of this protocol is to directly~     compare linezolid and vancomycin specifically for MRSA VAP.~   "
228027|NCT00572533|"~     First clinical evaluation of Smart Anemia Manager algorithm.~   "
228028|NCT00572520|"~     This study will compare the effectiveness of two weight loss programs, one supplemented with~     health education and the other supplemented with behavioral counseling, in treating women who~     are depressed and overweight.~   "
228029|NCT00572507|"~     MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall~     after midline incision. The primary objective of this trial is to demonstrate that the~     frequency of wound infection and the frequency of reoperation due to burst-abdomen after~     primary median laparotomy for elective surgical intervention are equal or lower than in the~     INSECT trial. The secondary objectives are to demonstrate that the length of postoperative~     hospital stay and the frequency of abdominal hernias 12 months after the surgery are equal or~     lower than in the INSECT trial. [Knaebel HP et al., 2005]~   "
228030|NCT00572494|"~     Prospective, multicenter, randomized clinical trial, Follow-up at 1-, 6- and 12 months~      This clinical investigation is first of all designed to demonstrate the safety and~     effectiveness of the MAGIC EXPLORER stent system. The primary objectives of the study are to~     evaluate the safety and 6-month patency of the bioabsorbable MAGIC EXPLORER stent in patients~     with stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries. Secondary~     endpoints are the procedural success, patency at all follow-ups, late lumen loss and~     limb-salvage rate. Peri-procedural complications (within 24 hours) will be evaluated.~     Furthermore, data of the balloon catheter PLEON EXPLORER will be collected to demonstrate its~     effectiveness and safety.~   "
228031|NCT00572481|"~     We hypothesize that variations in anatomic location of the arm lymphatic drainage system put~     the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the~     drainage of the arm during the procedure would decrease the likelihood of inadvertent~     disruption of the lymphatics and the subsequent development of lymphedema. A combination of~     radioactivity and blue dye will be used.~   "
228032|NCT00572468|"~     This is a randomized trial comparing the effect of oral simvastatin versus placebo on targets~     of the mevalonate pathway in men undergoing a prostatectomy as planned management for~     prostate cancer. Observed tissue effects will be correlated with changes in serum cholesterol~     and low-density lipoprotein.~   "
228033|NCT00572455|"~     To evaluate the safety and efficacy of PF-04217329.~   "
228034|NCT00572442|"~     The purpose of this research study is to perform serial magnetocardiographs (MCG)and~     cardiovascular risk factor assessments on individuals with no symptoms or history of heart~     disease. This small sized study of MCG in healthy individuals will allow for data collection~     for power analysis for a larger prospective trial.~      Volunteers are not compensated or paid.~   "
228035|NCT00572429|"~     HIV patients treated with Highly Active AntiRetroviral Therapy (HAART) show significant~     metabolic symptoms, such as lipodystrophy, dyslipidemia, and insulin resistance. A possible~     contribution to these symptoms in HIV/HAART is a decrease in mitochondrial function,~     resulting in a decreased fatty acid oxidation. A combined regime of aerobic and resistance~     training has been demonstrated to increase lean body mass and reduce overall fat and truncal~     fat and the levels of triglyceride and LDL cholesterol.~   "
228104|NCT00571493|"~     This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose of~     VELCADE in combination with BEAM and autologous hematopoietic stem cell transplantation and~     to obtain a preliminary estimate of the response rate to this combination.~   "
228036|NCT00572416|"~     1. This randomized clinical trial compares a four component behavioral sleep intervention~          group to an attention control healthy eating group~        2. The behavioral sleep intervention is designed to reduce fatigue in women with stages~          I-IIIA breast cancer receiving anthracycline-based chemotherapy~        3. The intervention uses an Individual Sleep Promotion Plan to promote daytime activity and~          nighttime sleep,and to decrease physchological and symptom distress~        4. The healthy eating group receives equal time and attention and information on healthy~          eating~        5. All participants receive a research nurse visit 2 days prior to each chemotherapy~          treatment, and 30, 60, 90 days after the last treatment, and one-year after the first~          treatment.~        6. Adherence to the intervention is calculated at each time~        7. Reliable and valid instruments are used, including wrist actigraphy~   "
228037|NCT00572403|"~     This research project will look at the relationship between baseline variables, and the new~     onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker,~     losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back~     for a 4-5 year follow up visit as part of a continuing project. We hypothesize that the new~     onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1~     year as well as being associated with elevated left ventricular mass index. The rate of new~     onset microalbuminuria in non-diabetics is not established and this prospective study will~     provide data.~   "
228038|NCT00572390|"~     By exploring hormonal status in hypopituitary women during oestrogen treatment and without~     estrogen substitution the influence on sexhormones and organ function is estimated.~   "
228039|NCT00572377|"~     Female sexual arousal disorder (FSAD) is a frequent finding in women in middle age and more~     prevalent in post-menopausal women. Topical alprostadil is currently under development for~     the treatment of FSAD. The purpose of this research is to determine if this formula of~     alprostadil is safe and effective in women with FSAD. We will be comparing alprostadil to~     placebo. Each participant will be treated for 1 month with active alprostadil and 1 month~     with placebo without knowing which they are using. This way, the investigators can compare~     the effects of alprostadil to the effects of an inactive topical gel.~      Post-menopausal women with FSAD will be recruited. The women interested in participating in~     the study will first meet with investigators and answer questions to make sure they are~     eligible for the study and fit the diagnosis of FSAD.~      Once enrolled, subjects will fill out questionnaires about their medical history, social~     history, and psychosocial history. They will also undergo medical examination. At this~     introductory research visit they will fill out baseline questionnaires, give medical history,~     undergo physical exam and have blood drawn. The informed consent will be reviewed and will be~     signed by the participant at this time.~      The subject will then return for the 1st treatment visit at which time vital signs like blood~     pressure and heart rate will be taken, external genitalia will be examined and study drug~     will be dispensed after randomly being assigned to either alprostadil or placebo. After~     instruction, the subject will use first dose in the clinic and be monitored for 2 hours~     looking for changes in vital signs or local genitalia reaction. If no problems are noted,~     subject will be sent home with study drug and Female Sexual Encounter Profile Cards (FSEP).~     The patient will fill out these cards with each sexual encounter. After 1 week patient will~     be contacted by phone and asked about side effects or concerns. After 4 weeks the subject~     will return for another study visit at which time FSEP cards and left over study drug will be~     collected, questionnaires will be filled out, labs will be drawn and subject will undergo~     exam of external genitalia. The subject will then be sent home for a 2 week washout period.~      The subject will return after this 2 week period with no study medication; she will then~     return and the above process will be repeated with either alprostadil or placebo (whichever~     she did not receive the first time).~   "
228040|NCT00572364|"~     The purpose of the study is to assess the safety and tolerability of AZD2281 following single~     and multiple oral doses in patients in Japan with advanced solid malignancies~   "
228041|NCT00572351|"~     Healthy pre-menopausal women will be recruited in order to test the effects of red wine and~     white wine on blood estrogen and progesterone levels. The women will be randomized and~     rotated through two different treatments (red wine, white wine). Estrone and estradiol are~     hormones in the category of estrogens. It is known that the bodies of both men and women may~     convert (or aromatize) a certain amount of naturally occurring testosterone into estrogen.~     Aromatase inhibitors have been used to prevent this conversion, or aromatization, of~     testosterone into estrogen, in the treatment of estrogen-dependent breast cancer in women.~     This inhibition leads to a marked decrease in estrogen (estradiol and estrone) levels.~     Naturally occurring aromatase inhibitors include grapes, grape juice, and red, but not white~     wine. The aromatase inhibitory effects are attributed to wine phytochemicals and not to~     alcohol. Based upon this information, the investigators will monitor the estrogen levels at~     various phases in the menstrual cycles of women since hormone levels naturally vary~     throughout the menstrual cycle. Several epidemiologic studies have found that there is a~     correlation with moderate to high levels of alcohol consumption and breast cancer. Therefore,~     study participants will be asked to drink only a eight ounces of wine which should have~     minimal or no risk for the development of breast cancer.~   "
228042|NCT00572338|"~     The purpose of this study is to learn how myeloma cells grow and become a cancer, how to~     distinguish them from normal cells and how to eliminate these cells selectively.~   "
228043|NCT00572325|"~     Our group has shown in a modeling study that increasing the radiation dose to pre-specified~     normal tissue dose constrains could lead to increased TCP with the same NTCP in patients with~     non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving~     non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to~     investigate its efficacy in a prospective study in patients with stage III NSCLC, who are~     selected for radical concurrent radiotherapy~   "
228044|NCT00572312|"~     The main purpose of the study is find whether the addition of statin (Atorvastatin) to dual~     renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme~     inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria,~     main prognostic marker of chronic kidney disease progression.~   "
228045|NCT00572299|"~     The purpose of this study is to determine the difference in response to bisphosphonate~     therapy in patients receiving excess glucocorticoids compared to patients with postmenopausal~     or male osteoporosis. Bisphosphonates are approved by the FDA for the treatment of~     postmenopausal women and osteoporotic men who are at high risk of fracture and in men and~     women with excess glucocorticoid administration.~   "
228062|NCT00572065|"~     This is an open-label, one arm, single institution study. Arsenic trioxide [TrisenoxTM~     Injection], 0.25mg/kg/dose administered intravenously over 2 hours.~      20 patients~      Complete remission, partial remission, clinical improvement, progressive disease, stable~     disease, relapse (per IWG consensus criteria, 2006) Clinical chemistry, hematology and ECGs~     will be assessed at least weekly during study treatments. Adverse events will be assessed in~     accordance with the NCI Common Toxicity Criteria, Version 2 at each study visit.~   "
228063|NCT00572052|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the~     29 gauge x 12.7 mm needle in obese subjects with diabetes.~   "
228046|NCT00572286|"~     The purpose of this research study is to apply new non-invasive, no-risk techniques to a~     cardiac transplant population for assessment of their reliability in detecting heart~     transplant rejection.~      Graft rejection remains a major factor limiting long-term survival despite continued~     advancement in the use of immunosuppression. Aggressive surveillance for the detection of~     acute rejection is therefore necessary. Repeated endomyocardial biopsy (EMB) (at least 11~     times the first year after transplantation) remains the only reliable surveillance method~     available. EMB is expensive, invasive, inconvenient to the patient, and associated with a~     significant incidence of serious complications. Therefore, it would be very important for~     patient care if new no-risk methods would prove to be effective in surveillance of rejection.~      This research study is designed to measure non-invasive ways to assess rejection along with~     the standard planned endomyocardial biopsies you will have after heart transplantation.~     First, the investigators plan to test the effectiveness of the investigational use of the CMI~     2406 Magnetocardiograph that has been approved by the U.S Food and Drug Administration (FDA).~     While the device used in the study is FDA-approved for the non-invasive measurements and~     recordings of the heart's magnetic field reflecting the heart's electrical currents, it is~     not yet approved for the specific use of detection of transplant rejection.~   "
228047|NCT00572260|"~     The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic~     antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of~     surgical site infection, and to evaluate the occurrence of adverse events.~   "
228048|NCT00572247|"~     The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation~     Weight Loss program in reduction of weight and body mass index (BMI.~   "
228049|NCT00572234|"~     Methamphetamine dependence is a significant drug use disorder in the Midwest. While a number~     of psychosocial and pharmacological treatments have been studied, no specific treatments for~     methamphetamine have been identified. This study is a collaborative pre-clinical and clinical~     partnership examining bupropion in the treatment of methamphetamine dependence.~   "
228050|NCT00572221|"~     The overall goal of this project is to increase the number of high quality nursing homes in~     Massachusetts. The study will evaluate an intervention involving two active treatment arms:~     one implementing a CQI program and a second implementing the CQI program and specific~     protocol programming. The intervention will be implemented in 24 nursing homes identified as~     performing, over multiple quality indicator domains, at a poor or average level across~     multiple outcome domains.~   "
228051|NCT00572208|"~     In this study we will focus on the postoperative recovery. A successful postoperative~     recovery should bring the patient to at least to the pre-surgical level. This can probably be~     achieved by a multimodal approach where at least postoperative pain and PONV are managed.~      The surgical injury results in immobilisation which again can result in impaired cardiac,~     respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an~     early return to the pre-surgical level. The preferred drugs for postoperative pain management~     are opioids. Although opioids are known to be an effective analgesia, they have a series of~     side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.~      Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported~     a significant better pain scores with Gabapentin in several studies -most of them restricted~     to the postoperative period in the post-anaesthesia care unit in many different kind of~     surgeries.~      We want to test if Gabapentin can be used instead of opioids for treatment of postoperative~     pain after heart surgery by median sternotomy.~   "
228052|NCT00572195|"~     The RNS® System LTT study is designed to assess the ongoing safety and to evaluate the~     long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of~     seizures in individuals 18 years of age or older with partial onset seizures that are~     refractory to two or more antiepileptic medications. Candidates will continue to receive~     their epilepsy medications while participating in the trial.~   "
228053|NCT00572182|"~     RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of MK0752 in treating~     young patients with recurrent or refractory CNS cancer.~   "
228054|NCT00572169|"~     With this study - Total Therapy IIIB - researchers are extending the findings of Total~     Therapy III based what they have learned from the first two studies (Total Therapy I and II),~     with new research strategies designed to explore why chromosome abnormalities found in~     persons with multiple myeloma affect the outcome of drug therapy used in this disease.~   "
228055|NCT00572156|"~     IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in~     response to another hormone called growth hormone. Growth Hormone is produced by a small~     gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors~     to growth during infancy, childhood, and adolescence.~      Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone~     and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but~     IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a~     type of growth hormone insensitivity and an inability to grow normally.~      This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will~     help children with IGFD grow taller more quickly than children treated with rhGH alone. The~     study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration~     (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH~     in children with IGF-1 deficiency (IGFD) is investigational.~   "
228056|NCT00572143|"~     The purpose of this study is to clarify cost effectiveness and quality of life issues among~     colon cancer patients followed up in a hospital setting or by their GP`s.Statement of study~     hypothesis:Postoperative follow up of colon cancer patients (according to national~     guidelines) by general practitioners will not have any influence on patients' quality of~     life. There will not be observed any increase in serious clinical events and cost~     effectiveness will be improved.~   "
228057|NCT00572130|"~     Rexin-G is a tumor-targeted gene medicine that is designed to seek out and destroy both~     primary tumors and metastatic cancers without the side effects of standard chemotherapy. The~     objectives of the study are: (1) to evaluate the clinical effectiveness of intravenous~     injections of Rexin-G, a tumor-targeted gene vector, in controlling tumor growth and~     prolonging life, and (2) to evaluate its over-all safety.~   "
228064|NCT00572039|"~     This randomized, controlled clinical trial will test the efficacy of Problem-Solving~     Treatment (PST) to improve vision function in older persons with age-related macular~     degeneration (AMD). AMD is a highly prevalent, disabling disease of aging that causes severe~     vision loss and functional decline. It is the leading cause of blindness in older persons in~     the United States and may affect more than 10 million people. Currently, there are no~     effective treatments to restore vision. Thus, improving Vision Function is a major goal of~     treatment. Vision function refers to vision-related abilities to perform daily living~     activities (e.g. reading recipes to prepare meals). Decrements in vision function will become~     a major public health problem as the population ages and the prevalence of AMD increases. PST~     is a brief, standardized, cognitive-behavioral treatment that teaches problem-solving skills.~      We believe PST will enable patients with AMD find practical solutions to vision-related~     problems and thereby improve vision function.~      We will recruit 240 AMD patients from the retina clinics of Wills Eye Institute,~     Philadelphia, PA, with bilateral AMD and visual acuity worse than 20/70 in the better eye.~     PST-trained therapists will deliver 6 1-hour, in-home sessions to the 120 subjects randomized~     to PST. The control treatment is Supportive Therapy (ST), a similarly structured,~     standardized psychological treatment that controls for the non-specific effects of treatment~     (n=120). ST contains no active elements beyond its non-specific components; in this way it is~     a placebo treatment. Independent raters, masked to treatment assignment, will assess Targeted~     Vision Function (primary outcome) and vision-related quality of life (secondary outcome) at 3~     months to assess PST's efficacy, and at 6 months to evaluate its long-term effects. As the~     population ages, the disability of AMD will become more prevalent, costly, and burdensome to~     patients, families, and ophthalmologists. This makes devising and testing practical and~     affordable interventions to improve vision function a national priority.~   "
228065|NCT00572026|"~     Among children, attention-deficit/hyperactivity disorder (ADHD) is associated with an~     increased risk for accidents, especially bicycle and pedestrian (Leibson 2001; Jensen 1988;~     DiScala 1998). Anywhere from 40% to 80% of children diagnosed with ADHD continue to display~     symptoms of the disorder into adolescence(Barkley 1990; Gittelman 1985). Adolescents with~     ADHD are also at an increased risk for driving-related accidents, being 2 to 4 times more~     likely to experience a motor vehicle accident (Barkley 1993; Barkley 1996; Cox 2000), 4 times~     as likely to be at fault in the accident (Barkley 1993), and over 3 times more likely to~     incur associated injuries as a result of the accident(Murphy 1996).~      Stimulant treatment with immediate-release methylphenidate (IR MPH) has been demonstrated to~     improve driving performance in adolescents with ADHD.~      Hypothesis to be Tested:~        -  Main study: Just as stimulant medication improves simulation and on-road driving~          performance of ADHD teenagers, it is hypothesized that stimulant medication will improve~          routine driving performance.~        -  Substudy - Extended wear (15 hours) of Daytrana will lead to safer driving late in the~          evening (22:00 and 01:00), when the most dangerous driving mishaps are most likely to~          occur, and the next morning at 09:00.~   "
228066|NCT00572013|"~     To determine the response rate, complete and partial, of patients with indolent lymphoma~     receiving Rituxan and BEAM with autologous stem cell transplant.~   "
228067|NCT00572000|"~     The purpose of this study is to assess the occurrence of serious adverse events (SAEs) as~     well as evaluate the occurrence of solicited local and solicited general symptoms and the~     occurrence of medically significant conditions reported throughout the study period.~   "
228068|NCT00571987|"~     In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This~     combination method will provide for excision of the cancer as routinely accomplished and~     ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing~     large volumes of tissue. This combined open technique will allow for full histologic analysis~     of the primary tumor and margin. Because no extra tissue is removed from the breast to~     generate negative margins it will result in better cosmesis than re-excision to obtain~     negative margins.~   "
228069|NCT00571974|"~     Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if~     not treated. There is no good treatment for these lesions, apart from surgery which is~     associated with significant side effects and physical deformation of the treated area.~      The investigators hypothesized that photodynamic therapy can be used safely and effectively~     to induce significant regression of oral leukoplakia.~   "
228070|NCT00571961|"~     The main purpose of this protocol is to study the effect of an HIV medication, Kaletra~     (lopinavir/ritonavir), on buprenorphine in non-HIV infected people who have been receiving~     the same dose of buprenorphine for at least 3 weeks.~      Study Hypothesis:~      Kaletra (lopinavir/ritonavir) will increase buprenorphine plasma levels without any~     significant clinical effect on the subject or need for dose adjustment.~   "
228071|NCT00571948|"~     The objective of this study is to determine the influence of an increase of meat in~     complementary food on iron status and the effect of an exchange of vegetable oil in the same~     food on the status of omega-3 fatty acids in infants in the second six months of life.~   "
228072|NCT00571935|"~     This trial is conducted in Europe.~      The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble~     human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.~   "
228073|NCT00571922|"~     This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus~     placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine~     dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36~     enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period,~     and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine~     positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period.~     Secondary measures include treatment retention, drug craving, mood, and safety.~   "
228074|NCT00571909|"~     We will enroll 20 patients to evaluate the effectiveness of a new operation known as~     videothoracoscopic splanchnicectomy (VSPL) for management of chronic kidney pain. This study~     is being done to test if this procedure is effective in controlling chronic kidney pain.~   "
228075|NCT00571896|"~     We are doing this study to see if using an over the counter mild laxative, SennaS, there is a~     difference in time required to have a bowel movement in women who are having surgery for~     prolapse (when your uterus and/or vagina drop after childbirth or with age) and/or~     incontinence (when you leak urine or stool without your control) as compared to a sugar pill~     or placebo.~   "
228076|NCT00571883|"~     RATIONALE: Surgery may be an effective treatment for oral cancer. It is not yet known whether~     surgery to remove the tumor and lymph nodes in the neck is more effective than surgery to~     remove the tumor alone in treating patients with early-stage oral cancer.~      PURPOSE: This randomized clinical trial is comparing two types of neck surgery to see how~     well they work in treating patients with early stage oral cancer.~   "
228105|NCT00571480|"~     Ear acupuncture can be used as a treatment for pregnancy induced low back pain.~   "
228077|NCT00571870|"~     Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of~     premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH)~     for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's.~      Many years have passed since GnRH antagonists were introduced to prevent premature LH surges~     during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist~     protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH~     outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent~     reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group.~     Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve~     better follicular and embryonic development and to improve the pregnancy rates in COH using~     GnRH antagonist.~      Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with~     current protocols, we hypothesized that a shorter duration of GnRH antagonist administration~     might improve outcome.~   "
228078|NCT00571844|"~     This study is an NIH-funded clinical trial conducted at Duke Medical Center evaluating the~     effects of the DASH diet alone and combined with a behavioral weight loss program on blood~     pressure and various vascular measures. Eligible patients must be unmedicated with blood~     pressure values ranging from approximately 130/85 to 159/99. Our primary hypothesis are as~     follows: (1) The DASH diet alone and combined with a behavioral weight management program~     will result in greater BP reductions than Usual Care controls at the end of the 4 month~     treatment period; (2) The DASH diet in combination with a behavioral weight management~     program will be more effective in lowering BP than the DASH diet alone; (3) The DASH diet~     alone and the DASH diet combined with the behavioral weight management program will result in~     greater improvements in cardiac, metabolic, and vascular function compared to the control~     condition; and (4) The combined DASH diet and weight management intervention also will be the~     most effective treatment in maintaining BP reductions at 1-year follow-up.~   "
228079|NCT00571831|"~     To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation~     of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light~     filtering intraocular lens(UV-filtering IOL).~   "
228080|NCT00571818|"~     The purpose of this study is to understand how the pancreas functions after transplantation~     and particularly why high blood sugar levels develop. It will also analyze the effect of the~     medicines used to prevent rejection on blood sugar levels.~      The hypothesis to be tested is that hyperglycemia more than six months after successful~     pancreas transplant results from a defect in insulin secretion, insulin resistance, or both.~   "
228081|NCT00571805|"~     Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on~     Day 8 and a 1 week quit attempt from Day 8-14.~   "
228082|NCT00571792|"~     To explore potential proteins that may be used to develop novel therapies for COPD. This will~     be accomplished by acquiring material from the lower respiratory tract via endobronchial~     brushings.~   "
228083|NCT00571779|"~     Feasibility study arm to evaluate the safety of adding the left atrial linear connecting~     lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of~     performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP)~     ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for~     patients with permanent or persistent Atrial Fibrillation (AF).~   "
228084|NCT00571766|"~     The purpose of this study is to evaluate the effects of oral L-Arginine in pregnant women~     with chronic hypertension.~   "
228085|NCT00571753|"~     The study is conducted to compare safety and efficacy of isoniazid administered as an~     adjusted dose based on NAT2 (arylamine N-acetyltransferase type 2)genotype and as a standard~     dose.~      The hypothesis is that the genotype-adjusted dose is superior to the standard dose with~     regard to hepatotoxicity and early treatment failure, respectively, in the group of slow and~     rapid acetylators of NAT2.~   "
228086|NCT00571740|"~     RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may~     also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more~     tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving cetuximab together~     bevacizumab works as first-line therapy, followed by combination chemotherapy and bevacizumab~     with or without cetuximab as second-line therapy in treating patients with stage IV~     colorectal cancer.~   "
228087|NCT00571727|"~     Long term study of the effects of dosing with rhIGF-1 on growth~   "
228088|NCT00571714|"~     The primary purpose of the study is to compare the safety and effectiveness of standard~     treatment for chronic hepatitis C using peginterferon alpha-2a (Pegasys) and ribavirin~     (Copegus) to those same medications plus a dietary supplement called betaine when added for~     the first 12 weeks of treatment.~      Peginterferon alpha-2a (Pegasys) and ribavirin (Copegus) are approved by the FDA (Food and~     Drug Administration) for the treatment of chronic hepatitis C.~      Betaine is a dietary supplement and occurs naturally in the body. It is not a medication~     regulated by the FDA or an approved drug for chronic hepatitis C.~   "
228089|NCT00571701|"~     This is a randomized double blind controlled study to determine if celebrex (celecoxib), a~     selective COX-2 inhibitor, can decrease the rate of recurrence in adult and pediatric~     patients with recurrent respiratory papillomatosis. All patients will be evaluated for~     disease severity at enrollment and at 3 month intervals for 30 months. After randomization,~     patients in the early treatment arm will begin celecoxib 6 months after enrollment. The~     delayed treatment arm will begin celecoxib 18 months after enrollment. All patients will~     receive celecoxib for 1 year. During the time that patients do not receive celecoxib, they~     will receive a placebo capsule with the same appearance. Follow-up visits will occur at three~     month intervals for the duration of the study.~   "
228103|NCT00571506|"~     The purpose of this study is to examine the effects of two diabetes medications,~     rosiglitazone and pioglitazone, on markers of vascular disease in subjects with type 2~     diabetes.~   "
228090|NCT00571688|"~     This study will evaluate the relative effectiveness of risperidone Consta injections~     occurring every 2 weeks in contrast to treatment as usual in preventing symptomatic relapse~     and rates of rehospitalization or admission into respite care for bipolar patients.~      Hypothesis: Risperdal Consta injections every 2 weeks will reduce the number of symptomatic~     relapses into mania, hypomania, mixed state, or depression, as shown by key indicators that~     include symptomatic relapse, rehospitalizations, emergency or urgent care visits, respite~     care, and intensive outpatient treatment as compared to treatment as usual.~   "
228091|NCT00571675|"~     This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to~     evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus~     docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic~     hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.~   "
228092|NCT00571662|"~     This is a continuation of a pilot study which is now regarded as a phase II trial with a plan~     to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with~     hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive~     regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic~     peripheral blood stem cell transplantation (alloPSCT).~   "
228093|NCT00571649|"~     This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in~     the leg and lung that can occur with patients hospitalized for acute medical illness, and~     compare these results with those of the standard enoxaparin dose and duration regimen. The~     safety of rivaroxaban will also be studied.~   "
228094|NCT00571636|"~     The objective of this randomized, double-blind trial is to compare the efficacy and safety of~     2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA~     <= 32 weeks in MV:~        -  Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl;~        -  Group B) continuous infusion of placebo + open label boluses of Fentanyl.~   "
228095|NCT00571623|"~     Following current standard-of-care, subjects data (brain pressure) will be recorded for 1~     hour and include 10-minutes of data during which the subject recieves chest physiotherapy~     (CPT). The hypothesis is that CPT is not harmful to brain pressure.~   "
228096|NCT00571610|"~     Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary~     sinus.~   "
228097|NCT00571597|"~     The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial~     fibrillation.~   "
228098|NCT00571584|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and~     safety of two dose schedules of activated recombinant human factor VII in treatment of joint~     bleeds in haemophilia patients with inhibitors.~   "
228099|NCT00571571|"~     Normal adolescence requires a successful resolution of identity crisis, which results in the~     development of satisfying relationships, success in school/work pursuits, and achievement of~     personal goals. Adolescents, who do not resolve this crisis, are at high risk for problems in~     those areas of functioning. Transference Focused Psychotherapy for Adolescents (TFP-A) is a~     treatment that specifically addresses these issues, permitting adolescents to develop~     satisfying friendships, more appropriate interactions with authority, and achieve realistic~     life goals.~      This study will evaluate the application of TFP-A, (a empirically validated treatment for~     adults with identity disturbance), to adolescents exhibiting the same behavioral and identity~     pathology. Subjects will be females; ages 14-21, with behaviors associated with identity~     problems, interpersonal difficulties with teachers, parents and/or peers, and live with their~     families. These adolescents will be randomly assigned to one of two treatment cells, TFP-A or~     Treatment as Usual (TAU). Subjects in TFP-A will receive weekly individual therapy for six~     months. The TAU group will receive standard individual therapy in the Outpatient Department.~     Both will receive medication as necessary. All subjects will participate in initial, weekly,~     and bi-monthly assessments during the six-month treatment period, and participate in a~     naturalistic follow-up study for an additional six months.~      Hypothesis:~      Adolescents with identity problems as seen in interpersonal, school, and/or family~     difficulties in the Transference Focused Psychotherapy for Adolescents (TFP-A) group will~     reduce these problem behaviors and improve management of their feelings and moods compared to~     adolescents with identity problems in the treatment as usual control group (TAU).~   "
228100|NCT00571558|"~     This phase I trial studies the side effects and best dose of photodynamic therapy using~     aminolevulinic acid in treating patients with oral leukoplakia. Photodynamic therapy uses a~     drug, such as aminolevulinic acid, that becomes active when it is exposed to a certain kind~     of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using~     aminolevulinic acid may be effective against oral leukoplakia.~   "
228101|NCT00571545|"~     We proposed to examine the effect of an aerobic exercise intervention on depression in~     persons with Traumatic Brain Injury (TBI). We will compare persons with chronic brain injury~     who are assigned to receive the exercise intervention with those in the control group to~     determine the effect of exercise on levels of depression and specific symptoms related to~     depression including anxiety, pain, sleep, and cognition. In addition, the effect of exercise~     on activity, participation level, and quality of life will be examined.~      HYPOTHESES:~        1. Participation in an aerobic exercise intervention will decrease the severity of~          depression in persons with chronic TBI.~        2. Participation in an aerobic exercise intervention will lead to improvements in negative~          symptoms associated with depression including anxiety, insomnia, pain, and impaired~          cognitive functioning.~        3. Participation in an aerobic exercise intervention will be related to improvements in~          activity and participation for patients with TBI.~        4. Participation in an aerobic exercise intervention will lead to improvements in~          perceptions of quality of life.~   "
228102|NCT00571519|"~     This is a 26-week, multicenter, randomized, double-blind, placebo and active~     comparator-controlled, parallel-group study in subjects with type 2 diabetes currently~     sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic~     monotherapy. Pioglitazone is used as active comparator. The total duration of a subject's~     participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a~     26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Subjects~     who complete the randomized portion of the study per protocol may have the opportunity to~     continue in a long-term extension study of active treatments.~   "
228106|NCT00571467|"~     The primary purpose of this study is to evaluate the safety of multiple doses of~     Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia~     Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be~     studied.~      Patients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100.~     A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients~     in a dose group before escalation to the next higher dose level. Patients will be followed~     for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet~     count(pharmacodynamics).~   "
228107|NCT00571454|"~     The purpose of this study is to determine whether telephonic depression care management can~     improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and~     are receiving an antidepressant from their primary care doctor.~   "
228108|NCT00571441|"~     We hypothesize that the stroke volume variation measured using the commercially available~     LiDCO monitor provides a reasonable estimate of volume when compared to standard measures.~     This study will collate data that is already being collected by the bedside nurses.~   "
228109|NCT00571428|"~     To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD~     (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate~     inhalation solution 15μg/2 mL BID in subjects with COPD.~   "
228110|NCT00571415|"~     Within this study patient data are collected from different imaging and motion monitoring~     devices that will be used to develop and test strategies for image-guided adaptive~     radiotherapy in cervix cancer patients.~   "
228111|NCT00571402|"~     This study will evaluate the effectiveness of family-focused psychoeducational treatment~     along with medication in treating adolescents with bipolar I disorder.~   "
228112|NCT00571389|"~     Primary Objective:~      This is a study to investigate the feasibility of harvesting, expanding in culture, and~     freezing circulating tumor cells and immune cells from cancer patients and healthy~     volunteers.~   "
228113|NCT00571376|"~     The purpose of this study is to measure the financial effects of health information~     technology and health information exchange in regional health information organizations in~     New York State.~   "
228114|NCT00571363|"~     We have compared to types of surgery to assess which one leaves the smaller surgical defect.~   "
228115|NCT00571350|"~     The purpose of this study is to assess the effectiveness of the polypropylene tape in~     preventing cystocele recurrence when placed underneath the bladder base as a concomitant~     measure to the anterior colporrhaphy procedure.~   "
228116|NCT00571337|"~     1 Project summary 1.1 Rational. Accent 1 study has demonstrated the superiority of Infliximab~     over placebo in a systematic treatment strategy of Crohn 's disease every 8 weeks during one~     year. However the optimal strategy beyond one year of treatment is not established.~     Particularly, the need for carrying on systematic treatment with infliximab in all the~     patients has not been demonstrated.~      1.2 Primary objective. Determine factors associated with a low risk of clinical relapse after~     stopping infliximab in CD patients in remission (CDAI<150) and regularly treated with~     infliximab for at least one year.~      1.3 Main objective and main judgement criteria. Determine predictive factors for relapse~     within one year after stopping infliximab. Main judgement criteria is the clinical relapse~     after stopping infliximab. Clinical relapse is defined either by a CDAI>250 or by a CDAI~     between 150 and 250 if this CDAI is confirmed over two consecutive weeks with an increase of~     at least 70 points over baseline for the two consecutive measures.~      1.4 Secondary objectives and judgement criteria. Determine the time to-relapse Determine~     predictive factors for short-term relapse (<2 months)after stopping infliximab.~      Determine response to infliximab retreatment in these patients. Determine tolerance to~     infliximab retreatment in these patients. Determine predictive factors for an absence of~     response to retreatment. Determine predictive factors for infliximab retreatment intolerance.~     Determine sustained response in the retreated patients.~      1.5 Type of study Open-label prospective study of stopping regular treatment. Inclusion~     period: minimum one year, possibly prolonged to reach 100 patients. Patients will be followed~     up every two months for at least 18 months after stopping infliximab.~      1.6 Justification of the number of patients Number of patients to include is at least 100.~     This recruitment should be reached within one year. This number should allow to disclose~     predictive factors associated with a relative risk of at least 2 if this factor is~     equilibrated (50% at risk patients) or 3 is this factor is disequilibrated (90% at risk~     patients).~   "
228117|NCT00571324|"~     The purpose of this study is to determine if Exendin-(9-39), an antagonist of the~     glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases~     fasting blood glucose levels in subjects with congenital hyperinsulinism.~   "
228118|NCT00571311|"~     This study will evaluate how adolescents enrolled in clinical research and their parents:~        -  Understood the study information presented before they agreed to participate~        -  Made decisions about enrolling in the study~        -  Experienced the process of assent and consent~        -  Perceive the experience of participating in research~      The study will determine how adolescents and their parents evaluate risk and benefit, what~     information they use in making their research enrollment decisions, and how these decisions~     are made.~      In recent years the medical community and the federal government have increasingly recognized~     the need to conduct pediatric research. Several initiatives have resulted in an expanding~     number of studies that include children. With more pediatric research comes the need to~     ensure that protections for the rights and safety of children enrolled in research are~     performing well.~      Adolescent patients between 13 and 18 years of age who are enrolled in a research study at~     the NIH involving cancer, diabetes mellitus, vaccines, obesity, bipolar disorder, and HIV, as~     well as healthy adolescent controls, may be eligible. One parent of each adolescent also~     participates.~      Participants are interviewed at the NIH Clinical Center. Each interview will last about 30~     minutes and consists of questions in the following areas:~        -  Demographics (age, sex, ethnicity, education, socioeconomic status, etc.)~        -  Brief medical history of the adolescent~        -  Experience and satisfaction with the parental permission/assent process~        -  Motivations for participating in clinical research~        -  Decision-making process~        -  Willingness to accept certain types and levels of hypothetical risks in a study,~          including those of side effects and invasive procedures~        -  Willingness to enroll with different chances of possible benefit~        -  Comparison with other activities~        -  General understanding of research~   "
228119|NCT00571298|"~     RATIONALE: After removal of visible cancer in the chest, chemotherapy drugs are used to kill~     or stop tumor cells from dividing, so that they stop growing or/and die. Cisplatin is~     currently used safely as in intra-operative treatment for malignant pleural mesothelioma.~     This study is aimed to determine if the addition of gemcitabine as a second intracavitary~     chemotherapy can be accomplished safely.~      PURPOSE: This is a Phase I trial to study the efficacy of combination chemotherapy consisting~     of gemcitabine and cisplatin administered in the operating room and put into the chest and~     abdomen for one hour. We are also looking at the effects of heating the chemotherapy to a~     temperature of 42 degrees Celsius and the effect of cytoprotection agents: amifostine and~     sodium thiosulfate to counteract potential side effects of chemotherapy.~   "
228120|NCT00571285|"~     Retrospective review of records in the Emory Movement Disorders clinic suggests vitamin D~     deficiency occurs in over 80% of patients with Parkinson's Disease (PD), much more frequently~     than in internal medicine clinics. Laboratory studies have suggested vitamin D could play a~     role in the development of PD. In addition, low vitamin D levels have been associated with~     slower walking speeds, worse memory and thinking, and depression.~   "
228310|NCT00568698|"~     The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in~     children with Type I Spinal Muscular Atrophy; to identify reliable outcome measures for HU~     treatment in Type I SMA; and to detect the clinical efficacy of HU treatment in children with~     Type I SMA.~   "
228121|NCT00571272|"~     Cholestasis is a condition in which bile is not properly transported from the liver to the~     small intestine. Cholestasis can be caused by an array of childhood diseases, including the~     genetic diseases Alagille syndrome (ALGS), alpha-1 antitrypsin (a-1AT) deficiency, bile acid~     synthesis and metabolism defects, and progressive familial intrahepatic cholestasis (PFIC) or~     benign recurrent intrahepatic cholestasis(BRIC). This study will investigate the natural~     history and progression of the four previously mentioned cholestatic liver diseases to~     provide a better understanding of the causes and effects of the diseases.~   "
228122|NCT00571259|"~     The study is a randomized, double blinded, prospective, multicenter, clinical trial. All~     patients requiring vascular access with a tunneled central venous catheter for hemodialysis~     are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml~     in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium~     Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both~     ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group~     will be less than the heparin arm.~   "
228123|NCT00571246|"~     The objective of this study is to evaluate the efficacy of topiramate (250mg) or lamotrigine~     (250mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in~     patients with comorbid AD and PTSD.~   "
228124|NCT00571233|"~     The purpose of this study is to determine if children with heart disease where there is only~     one pumping chamber(ventricle) have proteins (biomarkers) in the blood that can be used to~     monitor the function of their heart.~   "
228125|NCT00571220|"~     Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking~     bariatric surgery have T2DM. Although all surgeries result in significant weight loss and~     often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass~     (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the~     improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by~     weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance~     insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific~     anatomical changes after this surgery. While some determinants of impaired insulin secretion,~     such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in~     the incretin effect after GBP might be specific to this surgery. The aim of this study is to~     determine whether the magnitude of the incretin effect on insulin secretion is greater after~     GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients~     with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent~     weight loss on the incretin effect (difference in insulin secretion after comparable oral and~     intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding~     the mechanisms that produce improvement in their diabetes is increasingly important.~   "
228126|NCT00571207|"~     This research includes the evaluation of a checklist and on-site screening devices to~     pre-select drivers suspected of being drug-impaired. The reliability of a limited number of~     promising on-site screening devices will be investigated. The devices tested will have to be~     promising regarding both reliability and practicality. In addition to the scientific~     evaluation of the checklist and the oral fluid screening devices, the time consumption of the~     selection procedure as a whole (checklist + oral fluid screening) will be evaluated.~      Outcome of the study will be recommendations for the roadside selection procedure of drivers~     suspected of drug-related impairment. The recommendations will concentrate on the reliability~     of the selection procedure.~      The study is part of an EU project DRUID. Two other countries in Europe take part to this~     study along with Finland.~   "
228127|NCT00571194|"~     Many children with end stage renal disease develop hyperlipidemia. HMG-CoA~     (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are~     typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized~     in patients on dialysis. This study is designed to provide preliminary pharmacokinetic data~     for pravastatin in pediatric patients on peritoneal dialysis.~   "
228128|NCT00571181|"~     The purpose of this study is to compare manual administration of propofol and remifentanil~     and dual closed-loop using bispectral index as the control variable during rigid~     bronchoscopy.~   "
228129|NCT00571168|"~     1. Scientific background In patients with multiple myeloma high-dose chemotherapy followed~          by autologous stemcell transplantation is preferred to conventional therapy, since the~          superiority in respect to complete remission, complete remission duration, event-free~          survival and overall survival has been proven within well controlled clinical trials~          (Fassas et al., 2002; Goldschmidt et al., 2003).~           Nausea and vomiting are well known and the most distressing side-effects of a high dose~          chemotherapy regimen. The administration of selective 5-HT3-receptor antagonists (5-HT3~          RAs) in combination with a corticosteroid (= antiemetic standard therapy) is effective~          for the prevention of those adverse effects in 70 to 80 % of patients. However, 25 to 40~          % of the patients still suffer from vomiting and nausea in the delayed phase of the~          chemotherapy. Superior protection could be achieved with the addition of Aprepitant~          (EMEND®) to the antiemetic standard therapy in acute and delayed phases of highly~          emetogenic chemotherapies. The enhanced antiemetic protection can be maintained over~          multiple chemotherapy-cycles to an extent superior to that of standard therapy alone (de~          Wit et al., 2003).~           Furthermore addition of Aprepitant (EMEND®) to standard therapy was generally well~          tolerated and the impact of chemotherapy-induced nausea and vomiting (CINV) on daily~          life was significantly reduced (Hesketh et al., 2003; Dando & Perry, 2004).~        2. Trial Rationale Aprepitant (EMEND®) is a selective high-affinity receptor antagonist of~          human substance P/neurokinin-1 (NK1) and has been shown to inhibit emesis induced by~          cytotoxic chemotherapeutic agents and augments the antiemetic activity of 5-HT3 RAs~          (e.g. Granisetron, Ondansetron) and corticosteroids (e.g. Dexamethasone). Thus~          Aprepitant (EMEND®) in addition to antiemetic standard therapy has been shown to possess~          powerful superior protection and has been reported in several clinical trials to~          significantly improve both acute and delayed CINV.~      The aim of this study is to evaluate, during and up to 7 days after high-dose chemotherapy~     with Melphalan (moderate emetogenic drug) followed by autologous peripheral blood stemcell~     transplantation, an antiemetic treatment regimen in respect to efficacy and safety in~     patients with multiple myeloma. To the best of our knowledge effects of Aprepitant on~     Melphalan induced CINV have never been investigated.~   "
228130|NCT00571155|"~     The purpose of this study is to determine the feasibility, efficacy and safety of intravenous~     and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and~     symptomatic epilepsy in the period of neurosurgical intervention.~   "
228131|NCT00571142|"~     To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and~     visual acuity in patients with diffuse diabetic macular edema and their relation to renal~     disease.~   "
228184|NCT00570427|"~     The purpose of this study is to improve access to quality depression care for older,~     low-income, minority adults in public sector health care. The study will examine current~     depression care in a public sector geriatric clinic that serves mostly Spanish-speaking~     Latinos and pilot study assessments and treatments in order to lay the groundwork for a large~     study of quality improvement for depressed older minorities~   "
228132|NCT00571129|"~     Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and~     postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR~     is still controversial. We conducted a prospective, randomized study in order to evaluate 1)~     the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the~     perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site~     in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after~     DCR-operation.~   "
228133|NCT00571116|"~     This phase I trial is studying the side effects and best dose of arsenic trioxide when given~     together with disulfiram in treating patients with metastatic and progressive melanoma. Drugs~     used in chemotherapy, such as disulfiram and arsenic trioxide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving more than one drug (combination chemotherapy) may kill more tumor cells.~   "
228134|NCT00571103|"~     The purpose of this study is to see whether acamprosate (Campral) will curb the desire to~     gamble in people with pathological gambling disorder.~   "
228135|NCT00571090|"~     The aim of this study is to identify which ultrasonographic feature or a combination of~     features is the best predictor of thyroid cancer in thyroid nodules.~   "
228136|NCT00571077|"~     Patients over the age of 18 with thyroid nodules scheduled for surgery will undergo EIS scan.~     Each node will be scanned and graded form 1-5 (1=benign, 5=malignant). Results will be~     compared with final histopathology.~   "
228137|NCT00571064|"~     This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020)~     used to treat residents of assisted living facilities diagnosed with mild, moderate, or~     severe stage Alzheimer's disease.~   "
228138|NCT00571051|"~     The purpose of this research is to investigate the effects of mindfulness based stress~     reduction (MBSR) on measures of brain function. We are looking especially at the ways in~     which MBSR may affect the way the brain processes the sense of touch. The study seeks to~     recruit healthy, normal adults who are interested in MBSR training, a simple program that~     involves learning how to pay attention mindfully to the present moment~   "
228139|NCT00571038|"~     The primary purpose of this project is to establish the efficacy of a novel peer support~     intervention to reduce hypertension among members of veteran service organizations (VSOs).~     Specifically, we plan to demonstrate that veterans participating in a peer support~     intervention, as opposed to a purely didactic educational program, will have better blood~     pressure (BP) control, increased engagement in blood pressure lowering activities (such as~     exercise), and a more active stance as patients.~   "
228140|NCT00571025|"~     The purpose of this study is to determine the characteristics of those who obtain genetic~     susceptibility testing for Alzheimer's disease with APOE disclosure and to study the~     psychological and behavioral consequences of providing this information.~   "
228141|NCT00571012|"~     Intraocular pressure (IOP) varies with body position, with a significant increase occurring~     from the seated to the supine position. Previous research has indicated that the IOP increase~     cannot be explained by changes in episcleral venous pressure(blood flow leading away from the~     eye) alone. As well, previous research has indicated that aqueous flow rate is independent of~     body position. The purpose of this project was to determine if aqueous humor outflow facility~     varied with changes in posture.~   "
228142|NCT00570999|"~     This is a double blind, placebo controlled clinical trial, where patients with an advanced~     form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor~     cell (PBPC) transplant after which they are randomised to receive either placebo or a~     keratinocyte growth factor (Palifermin or Kepivance®).~      The function of Kepivance® is to stimulate the growth of epithelial cells. This drug has also~     been suggested to have an ability to help improve the reconstitution, or development, of the~     immune system after the transplantation.~      The hypothesis is that the patients T-cell dependent humoral immune response to recall~     antigen (PrevenarTM) will be higher in in palifermin treated patients than in the placebo~     control group~   "
228143|NCT00570986|"~     The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874~     versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.~   "
228144|NCT00570973|"~     Patients with liver cirrhoses and recent history of variceal bleeding, with HVPG documented~     non response to medical therapy with non selective beta blockers +/- mononitrates or variceal~     rebleeding during adequate medical therapy will be randomized to undergo either multi-session~     endoscopic multi-band ligation and continuation of medication or TIPS placement. Best~     treatment for this group of cirrhotic patients is not known so far.~   "
228145|NCT00570960|"~     The core of the proposal is a prospective, randomized, double-blinded, controlled study which~     will compare the efficacy of dextran 70 versus human albumin in the treatment of cirrhotic~     patients with spontaneous bacterial peritonitis (SBP). Because dextran 70, which is FDA~     approved for plasma volume expansion, is significantly less expensive than human albumin,~     this study is designed and powered to determine if dextran 70 is equivalent in clinical~     efficacy when compared to albumin.~      Specific aims for this project are to:~        1. Assess the effect of plasma volume expansion with dextran 70 on disease-specific~          mortality at 30 days in cirrhotic patients with spontaneous bacterial peritonitis~          compared to plasma volume expansion with human albumin.~        2. Assess the effect of dextran 70 compared to human albumin on the prevention of renal~          dysfunction within 30-days of diagnosis of SBP, as measured by the calculated creatinine~          clearance, plasma renin activity, serum aldosterone levels, levels of brain natriuretic~          peptide, and further development of the hepatorenal syndrome in cirrhotic patients with~          spontaneous bacterial peritonitis.~        3. Compare the survival to liver transplantation, treatment costs, hospitalization costs,~          resource utilization, and quality of life of patients with spontaneous bacterial~          peritonitis treated with dextran 70 and human albumin in the 30 days following~          diagnosis.~        4. Establish a comprehensive tissue bank of blood, ascites, and urine in patients with~          spontaneous bacterial peritonitis for future testing and translational research.~        5. Establish a clinical electronic database with web-based data entry and remote analysis~          capabilities linking tissue bank samples and patient outcomes related to the above~          clinical trials.~   "
230412|NCT00540618|"~     To compare disease activity, as measured by PASI score, of three MEDI-507 dosing~     (injection)regimens vs. placebo.~   "
228146|NCT00570947|"~     In this study we hope to show that prescriptions provided for CPR Anytime™ to patients who~     are at risk for or have heart disease at three key locations, can motivate families to learn~     the skill. We will use our ED sites, an office based primary care setting, and an office~     based cardiology practice. Participants will be given the pharmacy locations where they can~     be purchased. Optimally they will complete the program at home with their family.~      Research Hypothesis:~        1. Families of patients at risk for coronary artery disease can be motivated to learn CPR~          by receiving a prescription for a CPR Anytime ™ self learning kit.~        2. As part of the multiplier effect, an additional 1.5 family members per participant are~          projected to be trained to perform CPR.~        3. Families may experience a teachable moment when their loved one is in the emergency~          department. In comparison to the office settings, this may increase the likelihood that~          they fill the prescription for CPR Anytime® and complete the learning kit.~   "
228147|NCT00570934|"~     2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with~     Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone~     mineral turnover and/or bone mineralization.~   "
228148|NCT00570921|"~     The primary objective of this study is to determine if estrogen receptor-targeted therapy~     with fulvestrant used in combination with Everolimus is an effective and safe therapy for~     women with hormone receptor positive metastatic breast cancer after failure of aromatase~     inhibitor therapy.~   "
228149|NCT00570908|"~     The purpose of this study is to assess the efficacy and safety of concurrent whole brain~     radiotherapy (WBRT) and capecitabine followed by combination capecitabine and sunitinib in~     treating patients with CNS metastases from breast cancer.~   "
228150|NCT00570895|"~     Iron deficiency is a common health problem worldwide. Ferrous fumarate (a form of iron) is~     often added to foods in an effort to prevent iron deficiency. Vitamin C can improve the~     amount of iron that the body absorbs, therefore it is often added to foods too. However, we~     don't know if vitamin C really increases the absorption of iron from ferrous fumarate.~      This study will measure the iron absorption in children from a meal containing some ferrous~     fumarate with and without vitamin C. The study will include 4 visits to the Children's~     Nutrition Research Center in Houston, TX.~   "
228151|NCT00570882|"~     This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1~     regimen in previously untreated metastatic RCC to select the most promising regimen, which~     should be used in further studies of this patient population.~   "
228152|NCT00570869|"~     This research will be a prospective, cohort study to determine if mothers of infants/newborns~     are more willing to complete CPR training using a 22-minute instructional DVD and infant~     manikin versus traditional four hour didactic instruction.~      Study Hypothesis: A 22-minute instructional DVD and infant manikin will be an effective and~     preferred tool for teaching mothers of infants infant CPR.~      Objectives~        1. To determine if mothers of infants are more likely to complete infant CPR training with~          a 22-minute instructional DVD and infant manikin, than by attending a traditional CPR~          class.~        2. To determine if learning infant CPR with a 22-minute instructional DVD and infant~          manikin is as effective as attending traditional infant CPR class.~        3. To examine the number of mothers that were offered the opportunity to learn infant CPR~          either as part of their prenatal classes, or upon the birth of their infant.~        4. To examine the number of mothers who have been previously trained in CPR.~        5. To examine the reasons that mothers have been previously trained in CPR (e.g., mandated~          by work/career vs. personal reasons).~        6. To examine the multiplier effect of an at home CPR education using a 22-minute~          instructional DVD and infant manikin at the time of the follow up phone call.~   "
228153|NCT00570856|"~     To see the effect of Folic acid supplementation after kidney transplantation on plasma total~     homocysteine level and carotid intimal-media thickness~   "
228154|NCT00570843|"~     The objective of this study is to evaluate the effect of a new PEG based artificial tear as~     compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.~   "
228155|NCT00570830|"~     To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone~     acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation~     when combined with phacoemulsification and posterior chamber intraocular lens implantation~     (phaco/PCIOL) in eyes with severe uveitis.~   "
228156|NCT00570817|"~     Infusions with high-dose methotrexate 5 g/m2 or 8 g/m2 are used to treat children with acute~     lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma, medulloblastoma and ependymoma.~     Methotrexate is primarily excreted unchanged by the kidney where it can course acute kidney~     damage resulting in prolonged time of excretion of the drug. Our main hypothesis is that 12~     hours of intravenous hydration before the methotrexate infusion is more efficacious in~     preventing methotrexate induced kidney damage compared to four hours of hydration.~   "
228157|NCT00570804|"~     Objectives:~        1. Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.~        2. Assess MAPS and MAPS+ effects on treatment mechanisms (increased self-efficacy,~          decreased temptations/craving, decreased stress and negative affect) and the role of~          those mechanisms in mediating MAPS and MAPS+ effects on alcohol at-risk behaviors and~          smoking cessation.~        3. Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking~          and smoking cessation.~   "
228158|NCT00570791|"~     The primary purpose of this study is to evaluate the effects of ocular physical properties on~     intraocular pressure (IOP) measurements in eyes with healthy corneas using the following~     instruments to measure IOP: Goldmann applanation tonometer, pneumotonometer, ocular blood~     flow pneumotonometer, Tono-Pen, Pascal Dynamic Contour Tonometer and the Schiotz Tonometer.~     Ocular physical properties to be evaluated are:varying (CCT), corneal curvature (CC), axial~     length, anterior chamber depth and scleral rigidity. The secondary purpose of this is to~     determine if there is a correlation between CCT and other ocular properties, and which~     instruments that measure these other ocular properties are most affected by CCT.~   "
228159|NCT00570778|"~     This study will evaluate the safety and efficacy of QVA149 in patients with moderate to~     severe COPD.~   "
228160|NCT00570765|"~     The primary hypothesis is that INT 747 will cause a reduction in alkaline phosphatase levels~     in PBC patients, over a 12 week treatment period, as compared to placebo.~   "
228161|NCT00570752|"~     The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation~     in atherosclerotic plaque~   "
228162|NCT00570739|"~     This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl))~     study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will~     also be treated with open label, background,metformin HCl. Two-hundred sixty subjects with~     type 2 diabetes (T2DM) and 200 pre-diabetic subjects are planned to be be enrolled. Qualified~     subjects with T2DM will be randomized 1:1 to receive metformin HCl plus colesevelam HCl or~     metformin HCl plus placebo matching colesevelam HCl. Qualified pre-diabetic subjects will be~     randomized 1:1 to receive colesevelam HCl or matching placebo.~   "
228163|NCT00570726|"~     This study was designed to evaluate the efficacy and safety in the use of Ranibizumab, an~     effective vascular endothelial growth factor (VGEF) inhibitor, in treating patients with a~     failing bleb, characterized by increased fibrosis and vascularization of the conjuctiva,~     following trabeculectomy. Six subjects from one site will be enrolled in this study.~   "
228164|NCT00570713|"~     The purpose of this study is to investigate the activity of MORAb-009 when added to a~     standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or~     4 pancreatic cancer.~   "
228165|NCT00570700|"~     The purpose of this research study is to find out if a new anti-cancer drug, dasatinib~     (Sprycel®), previously approved for treatment of some forms of leukemia, will be safe and~     helpful in treating patients with hormone-refractory prostate cancer.~      This is a research study because the study drug, dasatinib (Sprycel®), has not been evaluated~     for safety or effectiveness in patients with hormone-refractory prostate cancer. The drug is~     approved by the Food and Drug Administration for treatment of some forms of leukemia; thus,~     dasatinib (Sprycel®) is not an investigational drug. It has been given safely to hundreds of~     patients already. However its safety and usefulness in this study population (prostate~     cancer) is unknown.~      Subjects who agree to participate will take 150mg (3 pills) of dasatinib (Sprycel®) daily by~     mouth for as long as the drug benefits them. During this time, the subject will periodically~     return to the office for blood/urine tests, X-rays, imaging scans, and/or to complete~     questionnaires.~   "
228166|NCT00570687|"~     The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled~     visits. The visits comprised an initial screening visit, 3 treatment visits for the meal~     challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3~     sequential visits for the glucose clamp, and a final close-out visit.~      Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for~     each completed subject. The visits comprise an initial screening visit, 2 treatment visits~     for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety~     visit, 2 sequential visits for the glucose clamp, and a final close-out visit.~      For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the~     clinical unit for all procedures.~   "
228167|NCT00570674|"~     The purpose of the Phase I part of this research study is to determine the safest and most~     effective dose of Abraxane when given in combination with carboplatin and Erbitux during~     radiation therapy for head and neck cancer. The purpose of the Phase II part of this study is~     to determine the effects of the treatment on head and neck cancers, as well as to further~     study the safety of this treatment.~   "
228168|NCT00570661|"~     The present study has been designed in order to evaluate safety and tolerability of ITF2357~     in patients with active SOJIA with inadequate response or intolerance to standard therapy~     with oral steroids and methotrexate, with or without previously used biologic agents, and to~     have a preliminary evaluation of efficacy of ITF2357 in the treatment of SOJIA.~      ITF2357 will be administered orally at the daily cumulative dose of 1.5 mg/kg: this dose in~     children/young adults is considered roughly equivalent to the dose of 1 mg/kg/day in adults,~     which so far has been proven to be free of any relevant safety concerns both in healthy~     volunteers and in patients.~   "
228169|NCT00570648|"~     Hypothesis: 1% sodium hyaluronate (Healon), applied at end of surgery to the surface of a~     corneal transplant will not shorten graft reepithelialization time when compared to coating~     with nothing. We also wish to measure and compare visual acuity in this immediate post~     operative period. We also wish to assess the safety of using this agent on the epithelium~     post-operatively.~      We will recruit 50 high risk patients (see inclusion criteria) here at the University of~     Virginia to randomly receive nothing or sodium hyaluronate (Healon) on the ocular surface at~     the end of surgery, and follow time to reepithelialization of the corneal transplant grafts.~   "
228170|NCT00570635|"~     The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in~     subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or~     intolerant of Imatinib and/or Sunitinib.~   "
228171|NCT00570622|"~     The purpose of this study is to investigate the response to pioglitazone on the hepatic~     venous pressure gradient and peripheral vascular responsiveness to vasoconstrictors in~     patients with advanced (Child´s Grade B or C) cirrhosis.~   "
228172|NCT00570609|"~     This is a prospective study of 7th grade students participating in the CPR Anytime® program.~     After consent, participants will be asked to complete the program with their parent(s)/legal~     guardian(s) and encouraged to include other friends and family members in the program. After~     completing the program, the participant and their parent(s) will be evaluated for adequacy of~     chest compressions/CPR. The student participants will be evaluated again at 6 months for~     adequacy of chest compressions/CPR~      Objectives:~        1. To evaluate 7th grade students for adequacy of CPR and chest compressions after~          completing a take home CPR course~        2. To evaluate the multiplier effect of students training in CPR with their parents/family~          members using a take home CPR instructional kit~        3. To evaluate the participating parent for adequacy of CPR and chest compressions after~          completing a take home CPR course~      Research Hypothesis:~        1. 7th grade students can be trained, using CPR Anytime®, to perform adequate chest~          compressions/CPR and their skills will be maintained at 6 months~        2. As part of the multiplier effect, an additional 1.5 family members per participant will~          be trained to perform adequate chest compressions/CPR~   "
228288|NCT00569010|"~     The goal of this clinical research study is to find the highest tolerable dose of Azacytidine~     (5-azacytidine) combined with cytosine arabinoside (ara-C) for the treatment of patients with~     relapsed and/or refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome~     (MDS). The safety and effectiveness of this treatment combination will also be studied.~   "
228173|NCT00570583|"~     Late-life depression (LLD) and cognitive impairment (CI) are significant public health~     problems among older adults, and their co-occurrence markedly increases disease burden and~     dementia risk. This highlights the importance of identifying and treating CI in LDD; however,~     current lack of reliable prognostic information from clinical, neuroimaging, and genetic data~     impedes research on targeted prevention and treatment. Two critical ways to close current~     knowledge gaps in predicting cognitive diagnostic outcomes of LLD involve: 1) increasing the~     number of diagnostic cases available to existing studies, and 2) using those studies to~     identify clinical, imaging, and genetic predictors that will improve future diagnosis. We~     intend to do both in the current proposal. We plan to study the following SPECIFIC AIMS:~      Aim 1: Identify baseline clinical-behavioral predictors of cognitive diagnostic outcomes in~     LLD.~      Working hypothesis: During acute LLD, CN will be associated with more frequent EOD and higher~     negative life stress than PCI and AD; PCI will be associated with EOD and higher frailty than~     CN and AD; AD will be associated with LOD, greater appetite loss, lower anxiety, and greater~     memory impairment than CN and PCI.~      Aim 2: Use multimodal neuroimaging at baseline to identify patterns associated with cognitive~     diagnostic outcomes in individuals with LLD. Working Hypothesis: CN will be associated with~     greater white matter integrity compared with PCI and AD; PCI will be associated with lower~     white matter integrity and network abnormalities in anterior cingulate cortex compared with~     CN; AD will be associated with lower hippocampal volume compared with CN and PCI.~      Aim 3: (exploratory): Explore interrelationships among candidate genes, cognitive diagnostic~     outcomes, and proposed phenotypic components relevant to LLD. Exploratory Hypotheses: 1) COMT~     val158met polymorphism will be associated with CN; 2) 5-HTTPRL and APOE ε2 polymorphisms will~     be associated with frailty; 3) genetic variation (SNPs) in TPH2 and AGTR1 will be associated~     with risk factors of AD: LOD, episodic memory, hippocampal volume, and appetite loss.~   "
228174|NCT00570570|"~     Gait impairment remain one of the main problem for hemiplegic stroke patients. After the 6~     first months, stroke patients are classically described with moderate or no improvement.~     Here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular~     strengthening program with conventional physiotherapy delivered by the local physiotherapist~     of the patient, in a very ecological way.~   "
228175|NCT00570557|"~     This research aims to facilitate the successful implementation of the new Heart and Stroke~     Foundation of Ontario dysphagia screening model for acute stroke patients. The objectives~     will be 1) to determine the natural history of dysphagia screening skill decay, and 2) to~     assess the benefit of independent web-based practice and periodic feedback on screening skill~     maintenance. We will enrol a convenience sample of nurses who currently work with stroke~     patients but who have had no prior formal training with dysphagia screening.~      The study will consist of 2 phases: A) an initial pilot phase followed by B) a prospective~     randomized controlled study. During Phase A, three new web-based, self-instructed skill~     refresher courses will be developed to help nurses maintain the skills they will learn in an~     8-hour workshop on dysphagia screening. During Phase B, nurses will receive the 8-hour~     workshop and one-on-one evaluation by a speech-language pathologist (SLP). Following~     training, competent screeners will be randomized into one of two groups: Group A - Control~     group with no refresher course or periodic feedback from SLP; Group B - Web-based skill~     refresher courses only. Nurses will be evaluated at several timepoints throughout Phase B to~     assess theoretical dysphagia screening knowledge and skills.~   "
228176|NCT00570544|"~     To evaluate if tiotropium (Spiriva)induced bronchodilation of inspiratory capacity in~     patients with moderate to severe copd subjected to metronome paced hyperventilation induced~     dynamic hyperinflation is dependent upon the extent of underlying emphysema as determined by~     high resolution-thin section CT lung.~   "
228177|NCT00570531|"~     The purpose of this study is to determine whether bevacizumab can improve the outcome of~     treatment for patients with esophageal cancer whose disease is confined to the esophagus or~     the closely surrounding lymph nodes.~   "
228178|NCT00570518|"~     The main purpose of the study is to determine the accident risk when driving under the~     influence of psychoactive substances, including alcohol (DUI). Other aims are to find out the~     prevalence of psychoactive substances in road traffic and to obtain information on the role~     of these substances in road traffic accident causations.~      For the purposes of the study, drivers of motorised vehicles are randomly stopped and~     interviewed and breath alcohol is recorded. Also, an oral fluid sample is taken and~     psychoactive substances are investigated in the laboratory. For cases, drivers injured in~     traffic accidents are asked to participate to the study. A whole blood sample and, if~     possible, an oral fluid sample is taken and psychoactive substances are determined in the~     laboratory. Also, people diseased in road traffic accident are included in the study. The~     information required for these subjects are taken from a register database.~      The study is part of an EU-project DRUID. Altogether 13 European countries take part to the~     study.~   "
228179|NCT00570505|"~     The purpose of this study is to determine whether the LAP-BAND system is safe and effective~     in subjects with BMI ≥ 30 kg/m2 and < 40 kg/m2.~   "
228180|NCT00570492|"~     The primary objective of this study is to characterize, as accurately as possible, the~     estimation of the difference in pre-pubescent growth velocities between subjects treated~     continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in~     the US, and placebo nasal spray as determined by stadiometry.~   "
228181|NCT00570479|"~     Retisert implant is an effective therapy for controlling inflammation in patients with~     non-infectious posterior uveitis. One of the major complications of this device is the~     development of elevated intraocular pressure (IOP) following implantation in 60% of patients.~     Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA)~     has been shown to reduce steroid induced elevated IOP. The purpose of this study was to~     evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to~     prevent this Retisert induced elevated IOP.~   "
228182|NCT00570466|"~     Interactive multimedia programs have been demonstrated to produce substantial change in~     children's dietary behaviors. This SBIR-Phase 2 protocol will evaluate the two video game~     interventions designed to change diabetes related behaviors, including diet and physical~     activity: Escape from Diab! and Nanoswarm that were developed in Phase 1. The primary~     hypotheses for this SBIR-Phase 2 protocol are:~        1. The two video games will result in greater dietary and physical activity change than a~          knowledge based control group.~        2. The effects of the video games will be mediated by changes in child preferences for FV~          and PA, self-efficacy to change FV intake and PA, and intrinsic motivation to eat FV and~          PA.~      We will test these hypotheses by evaluating the two video games in a randomized experiment.~     To minimize costs, we will evaluate the impact of the games on behavior (diet and PA), BMI~     and related psychosocial variables, but not blood values. Our long-term goal is reducing the~     incidence of Type 2 diabetes and related health problems in youth.~   "
228183|NCT00570440|"~     The primary objective is to determine if continuous COC use leads to higher continuation~     rates over 12 months of follow up than use of the standard 28-day COC regimen.~   "
228185|NCT00570414|"~     Secure airway management is the basis of all anesthesiological practice. Of particular~     importance is the securing of patients' airway passages when the surgical procedure itself~     poses a threat to a patient's airway, as is the case in all procedures involving the upper~     respiratory pathways. When adenoidectomies, tonsillectomies and combined adenotonsillectomies~     are performed, blood from the surgical area will present a respiratory threat to unsecured~     airways. The traditional opinion has been that endotracheal intubation is the safest method~     of preventing aspiration.~      The laryngeal mask was introduced in 1983 as an alternative to the endotracheal tube. In~     1990, the flexible, reinforced laryngeal mask airway was introduced, intended for use during~     surgical procedures involving the mouth and throat. The laryngeal mask airway has several~     potential advantages over the endotracheal tube. It is inserted blindly, without~     laryngoscopy. This leads to reduced oropharyngeal or laryngeal stimulation and injury, and~     therefore minimal activation of respiratory and circulatory reflexes. The laryngeal mask~     airway can be placed without the use of muscle relaxants, avoiding potential side effects~     such as apnea, hyperkalemia and anaphylaxis. In addition the laryngeal mask airway can remain~     in the throat until the patient awakes, virtually eliminating the danger of postoperative~     aspiration.~      Several international studies have described the advantages of the laryngeal mask airway over~     endotracheal intubation during ear, nose and throat surgery in children. The general~     impression is that there is a widespread routine implementation of the laryngeal mask airway.~     In Norway, however, this practice has been limited. As far as we know, only Namsos Hospital~     uses this procedure as its first choice. At Telemark Hospital we tested the use of laryngeal~     mask airway on 150 patients between May and December 2006. The results so far have been~     promising, and we have had no serious complications.~      Hypothesis:~      In children undergoing adenotonsillectomies, a laryngeal mask airway provides greater patient~     satisfaction (judged by reduced pain, nausea and vomiting) and greater effectivity (judged by~     reduced time in surgery), compared with the endotracheal tube. The laryngeal mask provides as~     much as or greater secure airway management measured by desaturations/Sp02<92% and/or use of~     suxamethonium and bronchiolytic drugs.~   "
228186|NCT00570401|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with~     advanced lung cancer that is no longer responding to erlotinib or gefitinib.~   "
228187|NCT00570388|"~     This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which~     includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment~     and this in turn will lead to improved ability to resist alcohol related cues and enhance~     involvement in psychosocial treatment.~   "
228188|NCT00570375|"~     The purpose of this research study is to find out what effects, good and/or bad, Erlotinib~     has on Myelodysplastic syndrome. Myelodysplastic syndrome is a group of blood diseases where~     the bone marrow (spongy space in long bones which is the factory for blood cell production)~     does not make enough blood cells and therefore there is a lack of healthy blood cells in the~     body. This can result in anemia, risk for infection and/or bleeding..~   "
228189|NCT00570362|"~     The purpose of this study is to evaluate whether systemic glutathione level is decreased in~     patients with normal tension glaucoma.~   "
228190|NCT00570349|"~     The primary objective of the trial is to assess the safety and tolerability of inhaled nitric~     oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable~     Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a~     decline in forced expiratory volume in one second (FEV1), or an increase in methemoglobin.~   "
228191|NCT00570336|"~     The purpose of this study is to determine if CTS-1027 can lower elevated liver enzymes in~     patients with chronic HCV infection.~   "
228192|NCT00570323|"~     Over the last 3 decades, a steady shift has occurred in the management of breast cancer.~     Because it was traditionally viewed as a local disease, many advocated the use of radical~     surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader~     biologic view that recognizes the often systemic nature of breast cancer, even when it~     appears to be localized to the breast. Results from randomized clinical trials have~     demonstrated that less extensive surgery, or lumpectomy plus radiation therapy, are optimal~     for local management of early breast cancer. In addition to the less radical approach to~     surgical treatment of breast cancer, other randomized clinical trials have established the~     value of postoperative systemic therapy in improving overall survival by eradicating~     micrometastatic disease, the major cause of mortality from breast cancer. Despite the~     well-documented benefits of adjuvant systemic therapy, it is not effective in preventing~     death from breast cancer in all patients who are candidates for such treatment. The worth of~     such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer~     is nearly always incurable. Currently, there are few reliable methods to predict the success~     or failure of a particular postoperative treatment modality, and better ways to predict and~     optimize outcome are needed.~      Combination endocrine therapy: Using endocrine agents with different mechanisms of action~     together has the potential advantage of more effectively blocking ER signaling, thus~     improving the efficacy of such agents against breast cancer. In the past, attempts to combine~     endocrine agents for ER-positive breast cancer have had mixed results, depending on the~     setting and the patient population studied.~      Endocrine agents without any agonist effect could potentially be used in combination with~     aromatase inhibitors, under the rationale that the combination would maximally blockade~     estrogen receptor signaling, thus potentially improving the antitumor effect. Fulvestrant~     (FASLODEX) is a pure estrogen antagonist with no known agonist effect; thus, it has the~     potential to provide additional benefit when combined with an aromatase inhibitor. This~     concept provides the rationale for using the combination of anastrazole and fulvestrant in~     this study.~   "
228193|NCT00570310|"~     The purpose of this study is to determine the best way to conduct clinical trials in patients~     with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect~     on neuropathic pain.~   "
228194|NCT00570297|"~     Bronchiolitis is a significant cause of morbidity and hospitalization in children, accounting~     for approximately 125,000 hospitalizations per year in the U.S. Recently, genetic variations~     of the β2-adrenergic receptor (β2-AR) have been shown to influence response to β2-AR agonist~     therapy in children with asthma. We suspect that genetic variations of the β2-AR also affect~     response to β2-AR agonist therapy in children with bronchiolitis.~   "
228195|NCT00570284|"~     The primary purpose of this study is to evaluate the effect of food on oral LBH589 in adult~     patients with advanced solid tumors. This study will also evaluate the safety and efficacy of~     LBH589 in adult patients with advanced solid tumors~   "
228196|NCT00570271|"~     A relevant reduction of blood pressure (BP) in placebo-treated control groups is a phenomenon~     often observed in pharmacological studies of hypertension. This effect was shown to differ~     from spontaneous remission tendencies and regression to the mean effect by comparing placebo~     groups with untreated controls. However, it is not fully understood whether these effects are~     due to a global reaction of the autonomous nervous system (affecting the overall organ~     systems of the body) or a specific reaction (affecting the cardiovascular system only). We~     therefore aim to differentiate specific effects (reduction of blood pressure) from global~     effects (e.g. changes in electrodermal and gastric activity).~      In our study we aim to test the following hypotheses:~        1. Placebo administration leads to a significant changes of blood pressure compared with~          untreated controls.~        2. The direction of blood pressure change depends on the type of suggestion (either~          decrease or increase)~        3. This effect is specific for blood pressure; changes in electrodermal and gastric~          activity do not differ between groups.~        4. The placebo response can be enhanced by a prestige intervention (information about the~          suggested drug action given by doctor or in written form).~   "
228289|NCT00568997|"~     This study will examine the risk of systemic malignancies in pediatric patients with atopic~     dermatitis exposed to Elidel 1% cream.~   "
228197|NCT00570258|"~     This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus~     fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progression~     after first line hormonal therapy.~        1. To obtain preliminary estimates of the magnitude and variability of the efficacy of~          fulvestrant in combination with erlotinib in this subject population, and~        2. To obtain historically up-to-date estimates of the magnitude and variability of the~          efficacy of fulvestrant as the sole active agent in this subject population.~      The measure of efficacy for both primary objectives will be time to progression.~   "
228198|NCT00570245|"~     The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide in~     prevention of lung graft dysfunction due to ischemia-reperfusion~   "
228199|NCT00570232|"~     The purpose of this study is to determine whether erlotinib will be effective in controlling~     cancer that has returned after treatment with salvage surgery and radiation. This study will~     also determine what effects, good and/or bad, this drug has on the participants.~   "
228200|NCT00570219|"~     The aim of this study is to determine whether valproate is effective in the treatment of~     benzodiazepine withdrawal symptoms in subjects receiving maintenance treatment for opiate~     dependence.~   "
228201|NCT00570206|"~     The purpose of this study is to examine the effects of Motivational Interviewing (MI) on~     probationer progress over a 6-month period, using probation officers as the MI providers.~   "
228202|NCT00570193|"~     The goal of this pilot study is to validate the use of the combination of Lucentis~     (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization~     (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a~     volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and~     as a tool for determining the need for retreatment.~   "
228203|NCT00570180|"~     Given the disappointing results with routine ASCT in t(4;14) patients, we propose this open~     label phase II study of bortezomib along with dexamethasone and pegylated liposomal~     doxorubicin (Doxil/Caelyx), referred to as the DBd regimen, for 4 cycles, followed by~     post-induction therapy with cyclophosphamide + bortezomib + prednisone (referred to as the~     CyBorP regimen) for 8 cycles. Since patients with t(4;14) remain at high risk for relapse,~     maintenance therapy with dexamethasone weekly will be given until disease progression.~   "
228204|NCT00570167|"~     To compare clinical, functional and radiological outcome after hip resurfacing and cementless~     metal-on-metal total hip arthroplasty.~   "
228205|NCT00570154|"~     Background:~      Patients who are pre-diabetic or have adult onset (type 2) diabetes have a significantly~     greater risk of developing heart, blood vessel, or kidney diseases.~      Recent studies have shown that abnormalities in white blood cell function may increase the~     chances of developing insulin resistance, the underlying problem in diabetic or pre-diabetic~     patients.~      Objectives:~      To determine levels of insulin sensitivity in selected volunteers.~      To compare the white blood cells of non-diabetic, pre-diabetic, and type 2 (adult onset)~     diabetic volunteers to evaluate possible differences in white blood cell function.~      Eligibility:~      Individuals between 21 and 60 years of age who (1) are non-diabetic, (2) are pre-diabetic~     (glucose intolerant or insulin resistant), or (3) have type 2 diabetes that is controlled by~     diet and/or medications other than insulin.~      Design:~      Evaluations before treatment:~        -  Blood tests, including screening procedures for blood-transmitted diseases such as~          hepatitis B and C, insulin sensitivity and glucose tolerance tests, and liver and kidney~          function tests.~        -  Pregnancy tests for women of childbearing age.~      Two tests will be performed during the study period:~        -  Glucose tolerance test to determine how well the body uses glucose.~        -  Blood drawn to study white blood cells.~      Participants will be financially compensated for the time spent during the study.~   "
228206|NCT00570141|"~     OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing~     wounds to explore the mechanism of action.~   "
228207|NCT00570128|"~     The purpose of this study is to determine whether donepezil HCl is effective and safe in~     improving cognitive dysfunction exhibited by children and adolescents with Down syndrome.~     Effectiveness will be measured by rating communication, daily living skills, and social~     skills and relationships in subjects aged 10 to 17.~   "
228208|NCT00570115|"~     The purpose of this study is to determine whether patients with obstructive sleep apnea have~     any changes in left atrial morphology and function evaluated by echocardiography three~     dimensional~   "
228209|NCT00570102|"~     The overall objective of the study is to assess whether complete avoidance of cow's milk (CM)~     proteins, for at least the first 6 months of life, prevents type 1 diabetes~     (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a~     mother, biological father or sibling affected by type 1 diabetes.~   "
228210|NCT00570089|"~     1. To evaluate the impact of ranolazine extended-release tablets in women with~          subendocardial ischemia due to microvascular endothelial dysfunction on myocardial~          ischemia (Cardiac Magnetic Resonance (CMR) extent, severity.~        2. To evaluate the impact of ranolazine extended-release tablets in women with~          subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of~          angina (Seattle Angina Questionnaire (SAQ), WISE angina frequency, Duke Activity Status~          Inventory(DASI) and SF-36).~   "
228211|NCT00570063|"~     To assess the efficacy and safety of an investigational compound PF-02545920 for the~     treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing~     symptoms associated with schizophrenia.~   "
228212|NCT00570050|"~     The primary aim of the study is to determine whether adjunctive intranasal insulin will exert~     an antidepressant effect when compared to placebo in adults with major depressive disorder~     (MDD), insufficiently responsive conventional antidepressants. There are three secondary aims~     of the study (1) to determine whether adjunctive intranasal insulin will alter emotional~     processing (i.e., cognitive-affective interface); (2) to determine whether early changes in~     emotional processing (i.e., after a single dose at 40IU intranasal insulin) predicts~     symptomatic improvement at study endpoint; and (3) to determine the effect of intranasal~     insulin on neurocognitive performance (e.g., learning and memory). This initiative represents~     a proof-of-concept study that insulin is important to depressive symptoms, neurocognitive~     functioning, and emotional processing deficits in MDD, representing a novel and safe~     therapeutic avenue.~   "
228213|NCT00570037|"~     Influenza causes epidemics of respiratory infection in young children each winter. Young~     children, particularly those under 6 months of age are most vulnerable to suffering from~     complications secondary to influenza infection. Consequently, influenza vaccine has been~     recommended for children 6-59 months of age. Influenza vaccine is not approved for use in~     children under 6 month of age who are at highest risk. Therefore, the Centers for Disease~     Control and Prevention Advisory Committee on Immunization Practices has recommended~     vaccination of household contacts of children under 6 month of age - a cocooning strategy.~      The current study is a hospital-based study to assess the effectiveness of a program to~     vaccinate birth mothers and household contacts of newborns with influenza vaccine. We propose~     to study both birth mothers and household contacts of newborns delivered at Durham Regional~     Hospital and Duke University Medical Center, birthing hospitals serving Durham and~     surrounding counties in central North Carolina. We will implement several strategies to~     increase vaccine coverage rates at Durham Regional Hospital utilizing Duke University~     Hospital as a comparison setting. Strategies will include: standing vaccine orders for birth~     mothers, vaccine reminders for household contacts, and a hospital based influenza vaccine~     clinic to increase vaccine accessibility for household contacts. Vaccine coverage rates will~     be assessed utilizing a survey method (maternal interview at the birthing hospital and a~     follow-up telephone contact 6-8 weeks later). We hypothesize that influenza vaccine coverage~     rates for new mothers and household contacts of newborns delivered at the intervention~     hospital will be higher when compared to coverage rates in the comparison hospital.~     Demographic determinants of vaccine coverage and reasons for refusal of influenza vaccine~     will also be assessed.~   "
228214|NCT00570024|"~     This research is being done because sudden and unexpected cardiac death remains a significant~     problem in patients with established coronary heart disease and accounts for 30% of deaths in~     this group (150,000 deaths annually) despite recognition and treatment of their heart~     disease. A large body of evidence implicates psychosocial stress as a risk factor and trigger~     for reduced blood flow in the heart, heart attack and sudden cardiac death, yet the specific~     mechanisms of this relationship remain under investigation. The nervous system, which plays a~     role in regulation of the heart, can influence cardiac arrhythmias (irregular heart beats).~     There are several studies that suggest that acupuncture improves anginal symptoms (like chest~     pain or tightness) and blood pressure, while reducing stress and improving overall quality of~     life. The reason that acupuncture seems to have a positive effect on these factors is thought~     to be that it helps the arteries and the nervous system to work better.~      It is possible to measure these effects in a systematic way. The functioning of the artery~     can be measured by Peripheral Arterial Tonometry, (PAT) a simple monitoring device that~     measures blood flow using finger probes and a blood pressure cuff. Changes in the nervous~     system can be measured by using a 24-hour Holter monitor to record the heart rate. The~     24-hour Holter monitor will also show if oxygen flow to the heart is decreased, as would~     happen during stress, by recording a continuous electrocardiogram (ECG). Feelings about~     stress can be established by questionnaires.~      The purpose of this study is to compare three groups of people with known coronary heart~     disease. One group will receive traditional acupuncture, one group will receive alternative~     acupuncture, and a third group will receive usual care only.~   "
228215|NCT00570011|"~     An international study in which patients with GHD were randomized to receive somatropin at a~     dose of either 3 microg/kg/day or 6 microg/kg/day for the first three months. The dose was~     then doubled (6 microg/kg/day, LD or 12 microg/kg/day, CD) for the next three-months.~   "
228216|NCT00569998|"~     This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery~     pens in the everyday life setting of patients with diabetes treated with insulin.~   "
228217|NCT00569985|"~     This pilot clinical trial studies biological therapy in treating patients with acquired~     immune deficiency syndrome (AIDS)-related lymphoma undergoing stem cell transplant. Giving~     chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them~     from dividing or killing them. After treatment, stem cells are collected from the patient's~     blood and stored. The stem cells are then returned to the patient to replace the~     blood-forming cells that were destroyed by the chemotherapy. Giving biological therapy as~     part of the stem cell transplant may be more effective in treating patients with AIDS-related~     lymphoma~   "
228218|NCT00569972|"~     To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on~     subjective wake after sleep onset in subjects with primary insomnia.~   "
228219|NCT00569959|"~     This study will examine whether fasting and non-fasting lipid measures can provide similar~     clinical information in order to guide lipid management by primary physicians. It will~     compare fasting vs. non-fasting lipid measurements in patients with and without diabetes.~   "
228220|NCT00569946|"~     To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)~   "
228221|NCT00569933|"~     Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied~     in orthopedic patients.~   "
228222|NCT00569920|"~     Postoperative pain and nausea may diminish a patient`s wellbeing, and may also delay~     rehabilitation, as well as increase the total cost of care and treatment. Opioids are~     effective drugs for treatment of pain, but with the disadvantage of side effects such as~     somnolence and nausea. The benefits of various types of non-opioid analgesic in reducing~     patients` postoperative need for opioids have been well-documented.~      One non-opioid prophylaxis documented for various surgery is short-term treatment with~     corticosteroids. The optimal dose of corticosteroids for peroperative nausea and pain~     prophylaxis is not well-documented. In our study we will attempt to determine whether the~     aforementioned benefits of corticosteroids are valid for a group of patients undergoing~     thyroid surgery.~      Hypothesis: Single-dose treatment with dexamethasone provides a better analgesic effect~     and/or reduced use of opioids than placebo in patients undergoing elective throid surgery.~     Higher dose of dexamethasone provide better and/or longer-lasting analgesic effects without~     influencing the side effect profile.~   "
228223|NCT00569907|"~     Approximately 30 adults will participate in this study at the International Diabetes Center~     (IDC). The IDC is the only site conducting this study.~      Length of participation can range from two to three months which will include four to seven~     clinic visits.~      The purpose of this study is to use a Continuous Glucose Monitoring (CGM) system to determine~     the characteristics of glucose control and patterns of food intake before exenatide is~     started, during the start and adjustment of exenatide and during exenatide treatment.~      The long-term purpose of this study is to determine to what extent continuous glucose~     monitoring improves or alters clinical decision making for patients treated with exenatide.~     And, the study will also compare CGM to conventional self-monitored blood glucose methods.~      The study will also compare subjects' changes, if any, in nutrient intake such as energy,~     protein, fat and carbohydrate during the course of the study through interpretation/analysis~     of self-reported food intake.~   "
228224|NCT00569894|"~     To assess the safety of FluMist vaccination~   "
228225|NCT00569881|"~     The prescribed antibiotic for prophylaxis of infection following PRK should be effective at~     eradicating a potential infection. In addition, the antibiotic should have a rapid onset of~     action, effectively penetrate the target tissue, and be safe and not toxic to any layer of~     the healing cornea, especially the epithelium. Several studies have investigated the toxicity~     of the fourth generation fluoroquinolones on the corneal epithelium and studies have~     demonstrated that gatifloxacin is less deleterious to the healing cornea than moxifloxacin.~     Most of these studies, however, have been conducted in animals. This was a retrospective~     chart review.~   "
228226|NCT00569868|"~     To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple~     myeloma participants undergoing VELCADE treatment for the first time.~   "
228227|NCT00569855|"~     Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs~     during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine~     is safe. This drug lowers the blood pressure, making it easier for the cardiopulmonary bypass~     machine to deliver blood and oxygen to all of the organs and tissues.~   "
228228|NCT00569842|"~     Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease~     (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay~     to see if doctors can detect which patients are at risk for GvHD and for getting an infection~     before they occur.~   "
228229|NCT00569829|"~     Although cognitive behavioral therapy (CBT) has been found to be efficacious in the treatment~     of child anxiety disorders, little progress has been made in the dissemination of such~     treatments to real-world practice settings. Clinical trials conducted in practice settings~     can demonstrate the degree to which evidence-based treatments are appropriate for larger~     scale dissemination. This study evaluates CBT as a treatment for child anxiety disorders in~     the elementary school clinic setting. A randomized, controlled trial design has been~     employed, comparing immediate treatment and a three-month waitlist. The trial is being~     conducted in several Los Angeles area elementary schools and is only available to children in~     these particular schools. To ensure that the CBT intervention is flexible and capable of~     matching the characteristics of various school settings, clinicians, and referred children, a~     modular treatment approach is employed. The study design includes elements to ensure high~     quality data, such as the use of independent evaluators and tests of treatment fidelity.~     Children, ages 5 to 12 years, are referred by teachers and staff or are identified as having~     high anxiety in concurrent studies. All participating children have DSM-IV diagnoses of~     separation anxiety disorder, generalized anxiety disorder, or social phobia, according to a~     semi-structured diagnostic interview. Therapy and clinical supervision is provided by the~     research team. It is hypothesized that children receiving immediate treatment will have~     significantly lower anxiety scores than children assigned to the waitlist at the~     posttreatment/postwaitlist assessment. If results are favorable, further exploration of~     dissemination of CBT into school clinic settings may be indicated.~   "
228230|NCT00569816|"~     Pharmacologic preconditioning by volatile anesthetics may depend on the mode of~     administration. The researchers hypothesize that a continuous administration in patients~     scheduled for CABG surgery prebypass will be less effective in terms of attenuating~     myocardial cell damage compared to a repetitive administration with a double wash in/wash out~     schedule. A control group will receive propofol as their primary anesthetic.~   "
228231|NCT00569803|"~     Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept~     Administered Subcutaneously to Healthy Subjects~   "
228232|NCT00569790|"~     The purpose of this study is to determine whether irinotecan, S-1, and bevacizumab are safe~     in the treatment of unresectable or recurrent colorectal cancer~   "
228233|NCT00569777|"~     The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal~     volunteers~   "
228234|NCT00569764|"~     To measure the long-term changes in weight and plasma lipids after switching antipsychotic~     treatment to aripiprazole~   "
228235|NCT00569751|"~     The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to~     compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™~     Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low~     frequency TAXUS related clinical events.~   "
228236|NCT00569738|"~     Imaging of neuroendocrine tumors (NETs) relies on conventional morphological methods and on~     somatostatin receptor scintigraphy (SRS). SRS is effective for carcinoid tumors, and for most~     pancreatic islet-cell tumors, but may fail to detect some tumors. Furthermore, this technique~     may require repeated imaging over 24-48 hours. Introduction of newer somatostatin analogs~     such as DOTANOC improves lesion detection. In addition, labeling with Ga68 and use of PET/CT~     improves the pharmacokinetics of the tracer resulting in better tumor visualization, and an~     easier procedure with imaging over only 1-2 hours.~      In this study, we propose to use Ga68-DOTANOC PET for imaging of various NETs, comparing the~     imaging data to those of anatomical and other functional modalities, and to histopathology,~     when available.~   "
228237|NCT00569712|"~     RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory~     from patients receiving budesonide and formoterol may help doctors learn more about the~     effect of budesonide and formoterol on gene expression and biomarkers.~      PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients~     with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung~     cancer, or with asthma treated with budesonide and formoterol.~   "
228238|NCT00569699|"~     The purpose of this study is to determine whether S-1 and bevacizumab are safe in the~     treatment of unresectable or recurrent colorectal cancer~   "
228239|NCT00569686|"~     Sixty patients with mild-to-moderate PAD (ABI 0.4-0.9) and hypertriglyceridemia (>200 mg/dl)~     already treated with statins will be imaged at baseline and randomized to Lovaza and placebo~     for 12 months. MR imaging will be repeated at the end of the 12-month period.~      We hypothesize that treatment of hypertriglyceridemia in patients with PAD with Lovaza will~     reduce atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1~     year compared to placebo. Secondary aims will be to show improved plaque characteristics~     (thickened fibrous cap, reduced lipid-rich necrotic core, improved exercise calf muscle~     perfusion using first-pass contrast enhanced MRI and improved exercise treadmill performance~     with Lovaza compared to matching placebo.~   "
228240|NCT00569673|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune~     system recover from the side effects of chemotherapy. Giving combination chemotherapy~     together with G-CSF or pegfilgrastim may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and~     trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or~     persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity~     cancer.~   "
228241|NCT00569660|"~     The goal of this clinical research study is to learn if azacitidine can help to control MF.~     The safety of azacitidine in patients with Myelofibrosis (MF) will also be studied.~   "
228242|NCT00569647|"~     Children with burns often require repeated reconstructive surgeries. These children tend to~     develop high levels of anxiety before coming to the operating room. Preoperative sedation,~     while somewhat effective in relieving this anxiety, has a number of side effects. The~     researchers hypothesized that preoperative anxiety could be effectively reduced by the~     utilization of a device which induces a relaxing hypnotic state through emmersion in a~     virtual reality environment.~   "
228243|NCT00569634|"~     The purpose of this study is to examine the agreement between venous blood gas and arterial~     blood gas measurements in patients in the Intensive Care Unit.~   "
228244|NCT00569621|"~     It is known that several common eye diseases are associated with ocular perfusion~     abnormalities. Moxaverine is used in the therapy of perfusion abnormalities in the brain, the~     heart and the extremities because of its direct vasodilatory effects. The present study~     seeked to investigate whether moxaverine alters ocular blood flow in healthy volunteers after~     intravenous administration.~   "
228245|NCT00569608|"~     Early discharge of premature infants from the Neonatal Intensive Care Unit will have~     substantial benefits:~      (i) diminish parental stress;~      (ii) increase parental - child bonding;~      (iii) diminish medical complications derived from prolonged hospitalization;~      (iv) reduce cost;~      (v) increase number of point of attendance disponible for future patients.~   "
228246|NCT00569595|"~     Poor diet, physical inactivity, and sedentary behaviors among low-income, minority~     populations have been linked to greater risk of chronic health conditions such as~     overweight/obesity, cardiovascular disease, and type 2 diabetes. Low-income clinics that~     serve these populations often represent an untapped opportunity for health promotion in~     impoverished individuals. This exploratory project proposes to address this scientific gap by~     introducing and conducting a randomized controlled pilot of the Self-Care Stimulating Disease~     Prevention Program to address poor dietary habits, physical inactivity, and sedentary~     lifestyle behaviors among low income, uninsured patient populations.~   "
228247|NCT00569582|"~     Patients will receive Corlux (mifepristone) daily for up to 24 weeks. Assessments of the~     signs and symptoms of Cushing's syndrome will be obtained.~   "
228248|NCT00569569|"~     The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral~     activity in age related macular degeneration currently presents a great challenge. With~     visual loss threatening, there are only very few therapeutic options.~      While these patients are neither suitable for laser therapy nor for photodynamic therapy with~     Verteporfin, antiangiogenic drugs applied intravitreally are now available.~      Some patients however reject this therapeutic option because of potential complications such~     as endophthalmitis and the frequency of necessary injections. 20 patients who rejected~     intravitreal therapy were treated with Anecortave acetate (Retaane®) which was applied as a~     juxtascleral depot injection.~   "
228249|NCT00569556|"~     The purpose of the study is to determine if a nurse managed, protocol driven, disease~     management process for diabetes results in improved attainment of therapeutic goals for~     diabetes compared to usual care. It is hypothesized that implementation of the disease~     management process will improve the percentage of diabetic individuals attaining all three~     therapeutic targets (HgbA1C<8.0%, LDL<100mg/dl, and BP<130/80mmHG) by 10% compared to usual~     care.~   "
228250|NCT00569543|"~     RATIONALE: Studying samples of urine in the laboratory from women with breast cancer may help~     doctors learn whether tamoxifen and aromatase inhibitors alter the metabolism of estrogens.~      PURPOSE: This clinical trial is studying the effect of tamoxifen or an aromatase inhibitor on~     estrogen metabolism in women undergoing treatment for newly diagnosed breast cancer.~   "
228251|NCT00569530|"~     The purpose of this study is to determine if the combination of late doses of Infasurf with~     inhaled nitric oxide will interact to improve the surfactant function and thus the~     respiratory status and outcome of treated infants.~   "
228252|NCT00569517|"~     The purpose of this pilot study is to assess patient accessibility, interest and response in~     order to design an adequately powered study to compare brief, group cognitive behavioral~     therapy (CBT) for weight loss to usual care in non-demented patients above the age of 18~     years old who are currently taking atypical antipsychotic medications. This pilot study is~     necessary, with current limitations of data in this area, to design an adequately powered~     study to address the difficulties managing metabolic syndrome risk factors in patients on~     antipsychotics.~   "
228253|NCT00569504|"~     The purpose of this study is to assess the cross-sectional prevalence of the metabolic~     syndrome in patients with schizophrenia taking antipsychotics.~   "
228254|NCT00569491|"~     The TAXUS ARRIVE study is a multi-center safety and surveillance study designed to to compile~     safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting~     Coronary Stent System in routine clinical practice and to identify low frequency TAXUS~     related clinical events.~   "
228255|NCT00569478|"~     The purpose of this study is to describe the effect and meaning of an outpatient-nursing~     programme including physical activity for patients with implantable cardioverter~     defibrillators (ICD).~      Hypothesis: The outpatient nursing programme will increase the perceived health and quality~     of life; improve the management of life from a patient perspective; reduce fear of exercise~     and increase physical capability and reduce the number of treatment-demanding arrhythmias.~   "
228290|NCT00568984|"~     This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of~     blood glucose control with combination therapy of repaglinide and metformin compared to~     conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes~   "
228256|NCT00569465|"~     It has been demonstrated that the nitric oxide production is reduced in type 2 diabetic~     patients and that cardiovascular complications represent 80% of the causes of death in these~     patients. As nitric oxide is able to reduce platelet aggregation, increase the relaxation of~     smooth muscle cells, and reduce plasminogen activator inhibitor-1 and endothelin, we~     hypothesized that nitric oxide deficiency is responsable for the cardiovascular disease in~     type 2 diabetes mellitus. Arginine and N-acetylcysteine, precursor and enhancer of the nitric~     oxide synthesis respectively, are able to increase nitric oxide production.~      Aim of the study is to evaluate the effect of arginine and N-acetylcysteine administration on~     arterial blood pressure and different metabolic parameters in patients with type 2 diabetes~     mellitus and hypertension.~      Subjects and methods. 24 male subjects, randomly divided in two groups, will be studied.~     These subjects will undergo a treatment with arginine (1200 mg once a day) plus~     N-acetylcysteine (600 mg twice a day) or placebo for six months. Basal and final evaluations~     include:~        -  general examination~        -  ABPM (ambulatory blood pressure monitoring)~        -  HbA1c, total-cholesterol, HDL-cholesterol, LDL-cholesterol, oxidized LDLs,~          triglycerides, reduced/oxidized glutathione ratio in red blood cells, nitrites/nitrates,~          asymmetrical and symmetrical dimethyl-arginine, nitrotyrosine, arginine, homocysteine,~          C-reactive protein, interleukin-6, tumor necrosis factor-α, intercellular and~          vascular-cell adhesion molecules, plasminogen activator inhibitor-1 and fibrinogen~        -  the ultrasound assessment of the intima-media thickness after endothelium-dependent~          flow-mediated vasodilation of the brachial artery~      Expected results. Increase of nitric oxide production and reduction of arterial blood~     pressure and oxidative parameters.~   "
228257|NCT00569452|"~     This is a pilot trial to establish study procedures that allow comparison of various starting~     basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control~     achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant~     basal rate (flat profile) will be compared during a composite fasting day as well as~     therapeutic success after 2 weeks of normal activity.~   "
228258|NCT00569439|"~     The purpose is to determine in term nulliparas with singletons that present in active labor~     (3-5 cm) or with ruptured membranes whether the administration of dextrose solutions to~     normal saline improves or expedites the course of labor. The researchers' hypothesis is that~     the addition of a carbohydrate substrate will shorten the length of labor and facilitate a~     vaginal delivery.~   "
228259|NCT00569426|"~     This trial is conducted in Europe. The aim of this trial is to compare two needle types when~     used with a disposable insulin injection pen in the everyday life setting of an insulin~     treated patient with diabetes.~   "
228260|NCT00569413|"~     The current study combines a molecular genetic perspective, self report and brain imaging to~     the study of human sexuality in control subjects and individuals from a sexual disorder~     clinic. The investigators hypothesize that the variability in components of the brain~     dopaminergic system expressed in the mesolimbic reward system can explain variability in~     human sexuality, especially in desire and pleasure associated with sex.~   "
228261|NCT00569400|"~     This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy~     and safety of human insulin produced by the current process and the NN729 process in type 1~     diabetes.~   "
228262|NCT00569387|"~     To assess the response for subjects with pancreatic cancer that have undergone surgical~     resection and treatment with a vaccine given with chemotherapy and chemoradiation.~   "
228263|NCT00569374|"~     This 7 week, open-label pilot clinical trial will examine the safety and tolerability of~     modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in~     methamphetamine-dependent volunteers.~   "
228264|NCT00569361|"~     Using a human pangenomic microarray, the researchers established expression profiles of nasal~     epithelial cells, collected by brushing of patients belonging to one of four distinct groups:~        1. allergic rhinitis to dust mite (AR) isolated (n=12),~        2. AR associated with bronchial hyperreactivity (n=12),~        3. AR associated with asthma (n=14),~        4. control (n=14).~   "
228265|NCT00569335|"~     Phase II trial of combination therapy with S-1, irinotecan, and bevacizumab (SIRB) in~     patients with unresectable or recurrent colorectal cancer~   "
228266|NCT00569322|"~     Determine if routine BG testing at the time of ICU admission is being done on all patients,~     irrespective of a prior diagnosis of diabetes mellitus, and whether it provides clinically~     important information.~   "
228267|NCT00569309|"~     RATIONALE: Vaccines may help the body build an effective immune response to kill cancer~     cells. Giving vaccine therapy after an autologous stem cell transplant may kill any cancer~     cells that remain after transplant.~      PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients~     who have undergone autologous stem cell transplant for high-risk lymphoma or multiple~     myeloma.~   "
228268|NCT00569296|"~     RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with~     antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the~     lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the~     number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated~     autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated~     autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients~     with recurrent, refractory, or metastatic non-small cell lung cancer.~      FUNDING SOURCE--FDA OOPD~   "
228269|NCT00569283|"~     RATIONALE: Giving donor natural killer cells to patients who have undergone donor bone marrow~     transplant may make the transplant work better and keep cancer cells from coming back.~      PURPOSE: This phase I trial is studying the side effects and best dose of donor natural kill~     cells in preventing relapse or graft failure in patients who have undergone donor bone marrow~     transplant.~   "
228270|NCT00569270|"~     We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease)~     patients with moderately severe disease using metronome paced hyperventilation (MPH) with~     inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung~     volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized~     crossover double blinded study.~   "
228271|NCT00569257|"~     The purpose of this study is to determine whether AEZS-108 shows anti-tumor activity and is~     tolerated in patients with gynecological tumors (ovarian / endometrial cancer) that have been~     shown to express receptors for the luteinizing hormone releasing hormone (LHRH)~   "
228291|NCT00568971|"~     The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with~     cisplatin and 5-Fu in patients with AGC.~   "
228311|NCT00568685|"~     The purpose of this study is to provide information regarding the relative effectiveness of~     three different atomoxetine doses in the treatment of Korean children and adolescents with~     Attention-Deficit/Hyperactivity Disorder (ADHD)~   "
228272|NCT00569244|"~     The investigational drug SH T00186D is an oral contraceptive. The investigational drug used~     in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone~     (DRSP).~      The aim of the present study is to evaluate efficacy and safety of the investigational drug~     in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during~     menstruation). Two different regimens of intake of the same investigational product will be~     compared.~      Patients have to undergo 2 -3 Baseline cycles (depending on whether the patient was an OC~     user before), during which menstrual pain, bleeding events, and pain killer intake have to be~     documented. During this observation period, the intake of hormonal contraceptives is not~     allowed. Other contraceptive methods (condoms with spermicide, pessary with spermicide) have~     to be used. If the patient is eligible for the study, she will be randomly assigned to one of~     the two treatment groups. Treatment group A will take the medication according to an extended~     flexible regimen, i.e., tablet intake will be triggered by bleeding events. Treatment group B~     will take the study medication in the 24 + 4 days regimen. That means, tablets to be taken on~     cycle days 1 - 24 contain the hormone combination, whereas tablets 25 - 28 do not contain any~     active ingredients, i.e., these are so called placebo tablets.~      Treatment will last at least 140 days, but can be prolonged in Treatment Group A depending of~     occurrence of menstrual bleeding. The overall study duration will be 10 months for each~     patient.~      During the whole study period, 5 visits are planned. At Screening and Final examination, a~     thorough physical examination and a gynecological examination (including breath palpation and~     cervical smear ) will be performed. Blood samples will be taken for safety laboratory~     parameters.~      Additional examinations can be performed any time, if this becomes necessary for medical~     reasons.~      Patients will be provided with a patient diary to document the intake of study medication,~     any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic~     (menstrual) pain and its intensity and its interference with daily activity, and intake of~     pain medication. The pain medication (ibuprofen) will be provided.~   "
228273|NCT00569231|"~     The purpose of this study is to look at how people respond to the treatment of warts through~     use of the Candida antigen to get an immune response to rid the body of human papillomavirus~     (HPV). The immune system is the part of the body that fights infections like HPV which causes~     warts. This research study will examine the response of your wart when injected with a~     portion of a common yeast (candida) which is the study drug. Your immune system response will~     also be looked at by doing a test called an ELISPOT assay. This test is done on blood~     samples. The results of this test may help us to determine how the Candida antigen affects~     your wart.~   "
228274|NCT00569192|"~     The purpose of this study is to examine the safety and efficacy of two doses of MAP0010~     versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week~     treatment period.~   "
228275|NCT00569179|"~     The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells~     that can be transfused following stem cell transplant.~   "
228276|NCT00569166|"~     RATIONALE: Paced breathing may be an effective way to reduce the number and severity of hot~     flashes in women who have survived breast cancer.~      PURPOSE: This randomized phase II trial is comparing three different programs of paced~     breathing to see how well they work in treating hot flashes in women.~   "
228277|NCT00569153|"~     The purpose of this study is to determine the safety and tolerability of TAK-700 in patients~     with asymptomatic metastatic, androgen independent prostate cancer.~   "
228278|NCT00569140|"~     The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic~     profile of E10030 intravitreous injection when administered as monotherapy or in combination~     with Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary~     to age-related macular degeneration (AMD).~   "
228279|NCT00569127|"~     This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b~     to see how well it works compared to octreotide acetate and bevacizumab in treating patients~     with high-risk neuroendocrine tumors that have spread to other places in the body~     (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally~     advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the~     growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as~     bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet~     known whether giving octreotide acetate together with recombinant interferon alfa-2b is more~     effective than giving octreotide acetate together with bevacizumab in treating patients with~     neuroendocrine tumor.~   "
228280|NCT00569114|"~     This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to~     determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell~     Lung Cancer in combination with erlotinib.~   "
228281|NCT00569101|"~     The purpose of this protocol is to determine whether Tacrolimus and Prednisolone are~     effective and safe in the treatment of the cyclophosphamide-resistant, refractory diffuse~     proliferative lupus nephritis~   "
228282|NCT00569088|"~     The purpose of this study is to determine whether the Chinese herbs formula is effective in~     the treatment of hemorrhagic stroke and to find out Chinese pathogeny and pathogenesis in the~     disease.~   "
228283|NCT00569075|"~     The goal of this study is to facilitate early diagnosis of gum disease. Proteins associated~     with cell death will be isolated from gum pockets of diseased and healthy patients and~     evaluated.~   "
228284|NCT00569062|"~     GW856553 is a novel compound, currently in development for the treatment of Major Depressive~     Disorder (MDD), and other indications. GW856553 inhibits a protein which is responsible for~     the production of some pro-inflammatory molecules, called cytokines. Increased blood levels~     of these molecules were seen in populations of MDD patients and this was more apparent in~     subjects with severe symptoms, psychomotor retardation and loss of energy. Aim of the present~     study is to assess whether GW856553, by inactivating this protein, is able to suppress the~     production of the cytokines, and ultimately relieving depression symptoms. In this study~     GW856553 or placebo is given to MDD patients 7.5md twice daily for 6 weeks.~   "
228285|NCT00569049|"~     This is a research-based study that is looking at the biologic features of breast tissue,~     lymph node tissue, or blood in order to study breast cancer development growth, and spread.~     Through tissue and/or blood samples we hope to gain further knowledge and understanding of~     how to improve diagnosis and treatment of breast cancer by identifying the molecular markers~     that predict clinical outcome and response to therapy.~   "
228286|NCT00569036|"~     This is a Phase 1 dose escalation study to determine the safety, tolerability,~     pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in~     patients with advanced or metastatic solid tumors. In addition, the study is expected to~     identify the recommended dose or dose range of BMS-754807 for Phase 2 studies~   "
228287|NCT00569023|"~     To assess the effect of oral administration of the alga Dunaliella bardawil containing~     approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual~     functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus).~   "
228292|NCT00568958|"~     In this study, 140 heavy drinking young adults (aged 18-25) will be provided with brief~     counseling and either naltrexone, a medication that is FDA-approved for the treatment of~     alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for~     administering low-dose naltrexone, in which daily dosing will be combined with targeted~     dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted~     naltrexone will result in greater reductions in frequency of heavy and any drinking compared~     with daily + targeted placebo.~   "
228293|NCT00568945|"~     This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in~     patients with the indication persistent atrial fibrillation.~   "
228294|NCT00568906|"~     This study will investigate gene expression profiles in normal human lung tissue, lung~     carcinoma and metastatic tumor to the lung. The expression of up to 20,000 genes in a given~     lung tissue sample will be examined by cDNA microarray analysis and compared to normal lung~     tissue. In addition, we hope to identify a particular subset of lung cancer cells with an~     enhanced capacity for proliferation and self-renewal , analogous to the stem cells recently~     identified for certain types of leukemia, breast cancer and brain tumors.~   "
228295|NCT00568893|"~     This trial is to obtain safety data in adult patients with severe sepsis and two~     sepsis-induced organ infections who receive an infusion of drotrecogin alfa (activated).~   "
228296|NCT00568880|"~     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving hydroxychloroquine together with bortezomib may kill more~     cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of~     hydroxychloroquine when given together with bortezomib and to see how well it works in~     treating patients with relapsed or refractory multiple myeloma.~   "
228297|NCT00568867|"~     The purpose of this study is to evaluate markers of immune response in human tumor samples.~   "
228298|NCT00568854|"~     The study hypothesis is that type 2 diabetics have abnormal cell-mediated immunity to~     tuberculosis manifesting as altered cytokine responses by peripheral blood mononuclear cells~     (PBMCs). This hypothesis will be tested using the live tuberculosis vaccine, Bacille~     Calmette-Guerin (BCG), in U.S.-born type 2 diabetics and nondiabetics. The investigators will~     control for potential confounding by age, sex, race, comorbidities, and select medications.~     Expression of key cytokines will be measured with real-time polymerase chain reaction.~   "
228299|NCT00568841|"~     This is a Phase-II Study to evaluate the accuracy of~     Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for~     early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC)~     treated with Erlotinib.~   "
228300|NCT00568828|"~     Earlier investigations have detected low levels of macular pigment (MP) in the center of the~     fovea and a halo of MP at a higher eccentricity in persons with type 2 idiopathic juxtafoveal~     teleangiectasia (MACTEL)[Helb H-M, Charbel Issa P, Pauleikhoff D, Scholl HPN, Holz FG,~     MacTel-Study Group. Macular Pigment Density and Distribution in Patients with Macular~     Telangiectasia. ARVO Annual Meeting 2006, Fort Lauderdale, 30.04.-5.05.2006. Program #~     5701/B795]. To date it is not known whether the total MP is reduced in MACTEL or whether even~     more MP accumulates at higher eccenticities compared to healthy probands. With the suggested~     study we aim to~        1. investigate Lutein and Zeaxanthin serum levels in MACTEL probands~        2. investigate and quantify MP at the posterior pole of MACTEL probands~        3. detect possible changes of MP concentration and distribution following supplementation~          with Lutein and Zeaxanthin~   "
228301|NCT00568815|"~     The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with~     ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse~     large B cell lymphoma (DLBCL).~   "
228302|NCT00568802|"~     The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in~     children with Types II and III Spinal Muscular Atrophy; to identify reliable outcome measures~     for HU treatment in Types II and III SMA; and to detect the clinical efficacy of HU treatment~     in children with Types II and III SMA.~   "
228303|NCT00568789|"~     The purpose of this study is to investigate the effects of ramelteon in elderly subjects on~     balance, mobility and memory impairment after awakening in the middle of the night following~     bedtime dosing.~   "
228304|NCT00568776|"~     The purpose of this study is to evaluate the dose-related safety and efficacy of multiple~     oral dosages of ELND005 as treatment for Alzheimer's disease (AD).~   "
228305|NCT00568763|"~     RATIONALE: Radiofrequency therapy and radiofrequency ablation use a high-frequency electric~     current to kill tumor cells. Radiofrequency therapy can also cause the body to produce~     heat-shock proteins which may help kill more tumor cells. Cryotherapy kills tumor cells by~     freezing them. It is not yet known whether heat-shock proteins caused by radiofrequency~     therapy given together with radiofrequency ablation or cryotherapy is more effective in~     treating stage IV melanoma than radiofrequency therapy-induced heat-shock proteins alone.~      PURPOSE: This randomized clinical trial is studying the side effects of radiofrequency~     therapy-induced endogenous heat-shock proteins when given alone or together with~     radiofrequency ablation or cryotherapy in treating patients with stage IV melanoma.~   "
228306|NCT00568750|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in~     treating patients with gastrointestinal stromal tumors.~   "
228307|NCT00568737|"~     Adult Patients with Severe Sepsis~   "
228308|NCT00568724|"~     The purpose of this study is to detect new urinary biomarkers that can be used as predictors~     on renal function in congenital hydronephrosis caused by unilateral ureteral obstruction~     (UUO) and to elucidate the pathophysiology of UUO.~   "
228309|NCT00568711|"~     New antibiotics are required to have not only the antibacterial activity against~     doxycyline-resistant O. tsutsugamushi but also lower risk for resistance or any~     cross-resistance to others.~      In this prospective, open-label, randomized trial, we enroll patients with mild-to-moderate~     scrub typhus. We compared the efficacy and safety of a 5-day rifampin therapy with those of a~     5-day doxycycline therapy at Chosun University Hospital, or one of its two community-based~     affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.~   "
228315|NCT00568633|"~     Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults.~     Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of~     patients. Bone marrow transplantation from a sibling donor may improve cure rates; however,~     patients over 50 years of age have a high risk of complications and therefore generally are~     excluded from this treatment option. Recently our group developed a transplantation strategy~     for older cancer patients that protects against transplant-associated complications, yet does~     not interfere with the ability of the transplanted donor cells to destroy cancer cells. With~     this new method, we can now safely evaluate transplantation as a curative therapy for AML~     patients over the age of 50. We have assembled clinical and scientific researchers throughout~     the state of California to study and compare bone marrow transplantation using our new~     approach with the best standard of care chemotherapy in AML patients over the age of 50. The~     results of this study have the potential to establish a new treatment standard that will~     improve survival of older AML patients.~   "
228316|NCT00568620|"~     In parallel with the increasing prevalence of obesity worldwide, type 2 diabetes mellitus~     (T2DM) has reached epidemic proportions. Despite a multitude of available therapies, only~     bariatric surgery (e.g., roux-en-Y gastric bypass (GBP)) has proven to be an effective long~     term treatment modality for morbid obesity. Moreover, the majority of T2DM patients who~     undergo GBP experience normalization of their blood glucose and are able to discontinue their~     anti-diabetes medications soon after the procedure. The insulin resistant state commonly seen~     in non-diabetic obese subjects also improves after GBP. Evidence from recent animal studies~     suggests that the rapid return to euglycemia seen in T2DM patients after GBP might in part~     result from excluding the duodenum from the flow of nutrients. With the use of enteral~     feeding tubes, we hope to better understand the factors in the human gut that may predispose~     obese individuals to the development of insulin resistance and T2DM.~   "
228317|NCT00568607|"~     The purpose of this study is to evaluate the efficacy and tolerability of the combination~     chemotherapy of DICE in the patients with NK/T cell lymphoma.~   "
228318|NCT00568594|"~     The purpose of this study is to determine: (1) the safety and pharmacokinetics of APL180~     administered as a single intravenous infusion in healthy volunteers, and (2) the safety,~     pharmacokinetics and pharmacodynamics of single and multiple daily intravenous infusions of~     APL018 in patients with CHD~   "
228319|NCT00568568|"~     The purpose og this study is to investigate the effects of growth hormon on insulin~     signalling pathways and the temporal association between administration of GH and developing~     of insulin resistance.~   "
228320|NCT00568555|"~     Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of~     Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural~     pain-reducing systems. In this study, we will administer both LDN and placebo to a small~     group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom~     Illnesses, to assess the drug's efficacy in treating the condition.~   "
228321|NCT00568542|"~     The study is testing the hypothesis, that the application of low dose erythropoetin beta (35~     I.E./kg BW/week) for 6 months following successful coronary revascularization by PCI improves~     left ventricular remodeling as assessed by cardiac MRI.~   "
228322|NCT00568529|"~     The purpose of this study is to evaluate the efficacy and overall survival of the regimen of~     XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory~     gastric cancer.~   "
228323|NCT00568516|"~     To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in~     patients with prostate cancer~   "
228324|NCT00568503|"~     This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The~     study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory~     effects of QAX028 compared to tiotropium and placebo in mild-to-moderate COPD patients.~   "
228325|NCT00568490|"~     The purpose of this study is to identify and confirm new blood and tissue markers for~     prognosis and tumor hypoxia. Tumor hypoxia, or the condition of low oxygen in the tumor, has~     been shown to increase the risk of tumor spread and enhance tumor resistance to the standard~     treatment of radiation and chemotherapy in head and neck and lung cancers. We have recently~     identified several proteins or markers in the blood and in tumors (including osteopontin,~     lysyl oxidase, macrophage inhibiting factor and proteomic technology) in the laboratory that~     may be able to identify tumors with low oxygen levels or more aggressive behaving tumors.~   "
228326|NCT00568477|"~     To evaluate the benefit of rituximab in patients with CAN with histologically proven C4d~     deposits and/or plasma cell and/or B-Lymphocyte (CD20+ cells) infiltration of their grafts.~   "
228327|NCT00568464|"~     The purpose of this clinical trial was to evaluate the efficacy and tolerability of the~     sequential therapy of VCD/IE in the patients with ESFT.~   "
228328|NCT00568451|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. It is not yet known~     whether giving paclitaxel together with carboplatin is more effective than giving~     temozolomide alone in treating patients with melanoma.~      PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel~     together with carboplatin or giving temozolomide alone works in treating patients with stage~     IV melanoma.~   "
228329|NCT00568438|"~     The goal of this study is to study NIS expression in benign and malignant breast and thyroid~     samples using archival formalin-fixed paraffin-embedded tissue sections.~   "
228330|NCT00568425|"~     The purpose of this study is show that intensity-modulated radiotherapy (IMRT), as compared~     with conventional radiotherapy, improves the precision of tumor targeting and reduces the~     acute and late effects of radiation toxicity when used to treat anal cancer. Results from~     this work will provide a basis for incorporating the use of IMRT to treat anal cancer in~     future treatment protocols.~   "
228331|NCT00568412|"~     To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and~     adolescents with mild to moderate atopic dermatitis~   "
228350|NCT00568165|"~     The aim of the study is to compare clinical management of patients with acute decompensation~     of heart failure, hospitalized in non cardiological ward, with the use of a mobile team~     including a cardiologist with portable echocardiography and standard care. The hypothesis is~     that a mobile team will lead to shorter hospitalization.~   "
228332|NCT00568399|"~     Cardiovascular disease is the major cause of death in the hemodialysis population and~     calcification of the major arteries (coronary, aorta, and carotid) are a play a central role~     in this process. The major causes of the calcification are many, including high levels of~     phosphorus, low levels of inhibitors of calcification, positive calcium balance, and~     oxidative stress. Once vascular calcification is present, it is usually progressive. There is~     no known treatment to reverse established vascular calcification.~      Sodium thiosulfate has been used extensively and safely to treat calcific uremic arteriopathy~     (a disease, in part due to calcification of small arteries) in dialysis patients. It~     increases the solubility of calcium by up to 100,000 fold and is also a potent anti-oxidant.~     It therefore has to potential to also decrease the amount of calcium in large arteries in~     dialysis patients and, hence improve survival.~      We will study hemodialysis (HD) patients at high risk for cardiovascular disease and death by~     obtaining a multidetector computerized tomography (MDCT) Scan of the coronary arteries,~     carotid arteries and aorta and an assessment of coronary artery stenoses by a simultaneous~     intravenous infusion of contrast. At the same setting, we will perform tests of pulse wave~     velocity (PWV) and carotid ultrasound carotid intima-media thickness(CIMT)studies. In those~     patients at high risk for cardiovascular death, defined as a coronary artery calcification~     score (CACS)of greater than 50, sodium thiosulfate at a dose of 12.5-25 gm/1.73 M2 will be~     infused over 15-30 minutes after each dialysis treatment for 5 months. The above studies will~     then be repeated.~   "
228333|NCT00568386|"~     To evaluate drop comfort, acceptability, preference and blur profile between two marketed~     artificial tears in both dry eye and non-dry eye patient population.~   "
228334|NCT00568373|"~     Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible~     patients.~   "
228335|NCT00568360|"~     Endoscopy is a standard part of the evaluation of patients with head and neck cancer used for~     determining the extent of tumor involvement. However, not all areas involved by tumor are~     apparent visually. Preliminary results indicate that compared with normal tissues, tumors~     have abnormal levels of capillary oxygenation. The purpose of this study is to determine the~     ability of non-pulsatile visible light tissue oxygen monitoring to differentiate normal and~     tumor tissue based on capillary oxygenation during endoscopy Should this be possible, this~     method could be used to mark tumor extent and invasion, even when that invasion is up to 5mm~     blow the tissue surface.~   "
228336|NCT00568347|"~     To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in~     stable patients with moderate-to-severe COPD who are current non-smokers and not on oral~     corticosteroids.~   "
228337|NCT00568334|"~     The aim of this study is to evaluate a modified formulation of GSK Biologicals' live~     attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative~     impact on vaccine safety. This present study is undertaken to rule out any negative impact on~     the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.~   "
228338|NCT00568321|"~     This study will test the efficacy and safety of two doses levels of RN624 versus placebo for~     the relief of pain caused by post-herpetic neuralgia (PHN).~   "
228339|NCT00568308|"~     The purpose of this study is to determine if PI-88 is effective and safe in patients who have~     had surgery to remove primary liver cancer.~   "
228340|NCT00568295|"~     To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis~     of the Knee~   "
228341|NCT00568282|"~     The primary aim of this study is to determine whether we can identify human lung cancer tumor~     cells in the peripheral blood of lung cancer patients.~   "
228342|NCT00568269|"~     The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method)~     and Lichtenstein (open method) repair on primary inguinal hernia.~   "
228343|NCT00568256|"~     Ulcerative Colitis is an Inflammatory Bowel disease that is a life-long, relapsing disabling~     disorder. Current treatments for Ulcerative Colitis are not satisfactory. Most medications~     provide only partial relief, are not successful for at least 30% of patients, and have major~     negative side effects. Mounting evidence indicates that stress is one of the important~     triggers that activates symptoms of ulcerative colitis and therefore causes flare-up. The~     primary aim of this study is to see if either of two 8-week Mind-Body courses has an effect~     in reducing stress and affecting the course and severity of UC.~      Hypotheses: Stress causes Ulcerative Colitis flare-up and stress reduction will prevent~     Ulcerative Colitis flare-up.~   "
228344|NCT00568243|"~     Background:~        -  The relation between eye movement and brain function is a subject of interest to the~          National Eye Institute.~        -  By comparing eye movement in healthy volunteers to research conducted on patients who~          have difficulty moving their eyes, the National Eye Institute hopes to develop and~          improve diagnostic procedures for people with eye diseases.~      Objectives:~      -The purpose of this study is to understand how we see visual patterns and how we move our~     eyes to see.~      Eligibility:~        -  Normal volunteers:~             -  must have no serious illnesses and must be 18 years of age or older~             -  who are 18 years of age or older must be willing to wear contact lenses that record~               eye movement.~             -  individuals with a history of eye or brain diseases, or previous eye or eye muscle~               surgery, are not allowed to participate in this study. Individuals who are~               currently using eye medications also are not eligible for the study.~        -  Patients:~             -  who are 18 years of age or older must be willing to wear contact lenses that record~               eye movement.~      Design:~        -  Participants will visit the National Eye Institute outpatient clinic for examination and~          testing.~        -  Participants will be screened with a medical history and eye examination (including eye~          pressure and eye movement tests).~        -  Participants with healthy eyes will participate in eye movement testing experiments:~             -  One or more sessions lasting less than three hours each.~             -  Eye movements will be recorded with either a special contact lens or a~               video/infrared camera system.~             -  For the majority of the studies done under this protocol, only one or two sessions~               will be required. A few studies recording very small eye movements will require~               three or more sessions....~   "
228345|NCT00568230|"~     Improvement of heart failure with moderate to severe mitral regurgitation using a~     percutaneously delivered implanted device.~   "
228346|NCT00568217|"~     We wanted to find out if the early use of antipyretics is capable in preventing recurrences~     of febrile seizures. When a child has had his/her first febrile seizure, the parents were~     instructed to give him/her antipyretic medication every time when the child had a new episode~     of fever during two years.~   "
228347|NCT00568204|"~     Atomised Methoxymethane-in-Aqua (MEXYN-A) a new topical self-chilled, non-steroidal,~     non-flammable, pressurised spray which embodies in one simultaneous application, most of the~     currently recognised and effective chemical, mechanical and thermal anti-pruritic therapies~     and hydrotherapy.~   "
228348|NCT00568191|"~     The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than~     Stratus OCT generated in a comparable amount of time. Due to this higher resolution the~     retinal surface and the retinal pigment epithelium can be identified more clearly, a~     significantly reduced number of algorithm failures is expected~   "
228351|NCT00568152|"~     A randomised three period cross over trial will be carried out in adults (19-64 years) to~     assess the acute and chronic effects of a large dose of apple procyanidin (PA) compared with~     a low dose of apple PA (negative control) and aspirin (positive control), on platelet~     function and other risk factors of cardiovascular disease. Platelet function will be assessed~     prior to a run in diet and at the start and end of each intervention. Volunteers will be~     assigned at random to consume 230grams of low PA apple puree or high PA apple puree or~     aspirin (75mg) each day for 2 weeks followed by a minimum 14 day wash out.~      Hypothesis: Consuming apple PA reduces platelet function consistent with reduced risk of~     cardiovascular disease.~   "
228352|NCT00568139|"~     Mitotane is standard therapy in the treatment of adrenocortical carcinoma. However, many side~     effects are not well documented. Therefore, we are aiming at collecting data about side~     effects in patients treated with mitotane~   "
228353|NCT00568126|"~     The purpose of this study is to find out whether Maca Root is effective for treating sexual~     dysfunction in females that is caused by antidepressant drugs. An additional aim of the study~     is to document the safety and tolerability of maca root, as well as any potential side~     effects that it causes.~   "
228354|NCT00568113|"~     The antioxidant effect of N-Acetyl cysteine can abort the inflammatory cascade responsible~     for initiation of preterm labour especially among patients with reccurent preterm birth and~     patients having bacterial vaginosis~   "
228355|NCT00568100|"~     The investigators' aim is to study the effect of pressure support ventilation at two levels~     of PEEP and Pressure Support versus neurally adjusted ventilatory assist (NAVA) in COPD~     patients.~   "
228356|NCT00568087|"~     The present study is designed to find out if N-acetylcysteine works in reducing alcohol~     drinking and craving.~   "
228357|NCT00568074|"~     This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety~     of repaglinide and Glurenorm® and Glucobay® given as the mono-therapy in Chinese subjects~     being treatment-naive type 2 diabetics.~   "
228358|NCT00568061|"~     The purpose of this study is to assess whether or not inhaled nitric oxide can decrease~     myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment~     elevation MI (STEMI) who undergo successful percutaneous coronary intervention.~   "
228359|NCT00568048|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor~     cells by blocking blood flow to the tumor. Giving temozolomide together with bevacizumab may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving temozolomide together with~     bevacizumab works in treating patients with stage IV melanoma that cannot be removed by~     surgery.~   "
228360|NCT00568035|"~     The purpose of this study is to determine whether QR-333 is safe and effective in the~     treatment of diabetic neuropathy as compared to placebo.~   "
228361|NCT00568022|"~     The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated~     dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in~     Japanese participants with metastatic breast cancer.~   "
228362|NCT00568009|"~     This is a randomized, double-blind, placebo-controlled, multi-center, sequential cohort study~     in subjects with congestive heart failure (CHF) and impaired renal function who are on stable~     furosemide treatment (³ 40 mg daily). A total of 50 subjects will be randomized to each~     increasing dose level of SLV320 or placebo in a sequential fashion.~   "
228363|NCT00567996|"~     This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo~     or salmeterol in patients with chronic obstructive pulmonary disease.~   "
228364|NCT00567983|"~     The purpose of this study is to evaluate the effect Restasis has in regards to disease~     progression.~   "
228365|NCT00567970|"~     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor~     and cause less damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic~     radiation therapy in treating patients with liver metastases.~   "
228366|NCT00567957|"~     The purpose of this study is to determine whether remifentanil use in preeclamptic patients~     may blunt hemodynamic response to intubation during general anesthesia for cesarean section.~   "
228367|NCT00567944|"~     The purpose of this study is to evaluate the safety and efficacy of the BrainPort balance~     device in improving balance in people with balance deficits due to stroke.~   "
228368|NCT00567931|"~     This phase I trial is studying the side effects and best dose of 1-methyl-D-tryptophan in~     treating patients with metastatic or refractory solid tumors that cannot be removed by~     surgery. Biological therapies, such as 1-methyl-D-tryptophan, may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth and by stimulating the immune~     system.~   "
228369|NCT00567918|"~     To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients~     with vernal keratoconjunctivitis~   "
228370|NCT00567905|"~     The purpose of this study is to examine the effect of green tea extract (GTE) on type 2~     diabetes and to explore the relationship between GTE and related hormone peptides.~   "
228371|NCT00567892|"~     The goal of this trial to see if repetitive transcranial magnetic stimulation (rTMS) to the~     hearing area of the brain can lessen the perception of tinnitus. rTMS uses a strong magnet~     and when placed against the scalp generates a small electrical field within the brain.~     Depending on the frequency of the stimulation, this electrical field can either decrease or~     increase the electrical excitability of the brain. In this study, low-frequency stimulation~     will be used, which is thought to decrease nerve activity. It is this electrical excitability~     of the brain that is thought to be responsible for tinnitus.~      The hypothesis of this study is that rTMS can decrease the perception of tinnitus.~   "
228372|NCT00567879|"~     The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both~     intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and~     efficacy of the combination in adult female patients with HER2+ metastatic breast cancer~   "
228373|NCT00567866|"~     This study will test the ability of a medicine (Quetiapine) that is used to treat~     schizophrenia or bipolar disorder to reduce the effects of methamphetamine that make it~     difficult for users to stop using it. This study will test the ability of a medicine that is~     used to treat schizophrenia or bipolar disorder to reduce the effects of methamphetamine that~     make it difficult for users to stop using it. The investigator thinks quetiapine will lessen~     the effects of methamphetamine.~   "
228374|NCT00567853|"~     The purpose of this study is to collect data on the effectiveness and clinical outcomes of~     the MEMO 3D Annuloplasty ring as used for mitral valve repair.~   "
228375|NCT00567840|"~     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral~     administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly~     diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard~     TB treatment.~   "
228376|NCT00567827|"~     Pneumonia is a common cause of morbidity and mortality. The diagnosis of pneumonia from the~     microbiology perspective has been challenging. Recent reports suggest the utility of nuclear~     acid detection for rapid and accurate diagnoses of these pathogens and their~     antibiotic-resistant spectrum. Extracted bacterial nucleic acid in sputum specimen will be~     identified by Nuclear acid detection assay kit with Microfluidic Pumping Chip and LAMP~     methods~   "
228377|NCT00567814|"~     Subjects will be randomly assigned to receive either one of the two potential dose~     combinations of the study medications or placebo over 6 weeks. The study will include twice~     weekly visits to the research clinic for laboratory studies, safety assessments and urine~     drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.~   "
228378|NCT00567801|"~     The purpose of this study is to prove the findings of a preliminary study which strongly~     suggest the hypothesis that the result of conventional embolectomy for acute, severe~     lower-limb ischemia can be improved by controlled reperfusion.~   "
228379|NCT00567788|"~     This is a randomized observer-masked cross-over study to compare the intraocular pressure~     (IOP) reducing effect of latanoprost with bimatoprost in subjects with chronic angle closure~     glaucoma (CACG) with raised IOP. Study subjects will be randomized to receive either~     latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be~     crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the~     medications will be assessed by the reduction in IOP after each medication compared to~     baseline. The study will be carried out in at least 2 Singapore hospitals.~   "
228380|NCT00567775|"~     This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic~     profile of two different methods of insulin administration in children with type 1 diabetes.~   "
228381|NCT00567762|"~     To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in~     patients with vernal keratoconjunctivitis~   "
228382|NCT00567749|"~     This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc.~     Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests)~     in pediatric subjects who are between 12 and 17 years of age. A minimum of ten (10) known~     HIV-positive participants will be tested.~   "
228383|NCT00567736|"~     The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in~     patients with chronic low back pain compared to waiting list group, or placebo.~   "
228384|NCT00567723|"~     Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are~     receiving dialysis will be followed for 5 years to compare mortality, bone fractures and~     incidence of selected morbidities to patients with no lanthanum exposure and to patients~     being treated for hyperphosphatemia with any marketed product.~   "
228385|NCT00567710|"~     This is a prospective, six-week, randomized, double blind, placebo-controlled, multi-center~     study in patients with schizophrenia who are experiencing an acute exacerbation of psychosis.~   "
228386|NCT00567697|"~     A prospective multicenter study comparing patients with CRVO amd secondary macular edema~     treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be~     randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will~     be monthly visits with injection the first three months and subsequently new injection if~     present edema.~   "
228387|NCT00567684|"~     The goal of this clinical research study is to use computed tomography urography (CTU) scans~     and intravenous urography (IVU) scans to check the status of urothelial cancer, in order to~     try to learn the level of effectiveness of possibly using CTU by itself in future patients.~   "
228388|NCT00567671|"~     Prospective, randomized, single site study to determine the safety and effectiveness of~     performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with~     corneal ectasia or progressive keratoconus.~   "
228389|NCT00567658|"~     The purpose of this research study is to measure the effects of the drug, esomeprazole 40 mg~     (Nexium) or placebo (inactive drug) on vocal cord granulomas.~   "
228390|NCT00567645|"~     The purpose of this study is to assess whether baseline sympathetic innervation in patients~     with chronic heart failure (CHF) is predictive for response to cardiac resynchronization~     therapy (CRT). And to assess whether response to CRT coincides with restoration of regional~     sympathetic innervation.~   "
228391|NCT00567632|"~     The determination of reference values is a necessary basis for research and clinical routine~     testing for pneumococci antibodies~   "
228392|NCT00567619|"~     Evaluate burden of disease in Patients with newly occurred upper GI symptoms related to GERD~     (symptom frequency & severity, QoL, lifestyle modifications, self-medication) - baseline data~     according to GERD impact scale presenting to specialists, especially internists~      - Evaluate effect of treatment with a acid suppressive therapy on these parameters: looking~     for improvement of symptom burden and quality of life according to the GERD impact sca~   "
228393|NCT00567606|"~     The purpose of this study is to test whether strength/weight training exercises enhance the~     effectiveness of calcium, vitamin D, and risedronate for the prevention and treatment of~     osteoporosis in postmenopausal breast cancer survivors.~   "
228394|NCT00567593|"~     The purpose of this study is to determine the effect of rosiglitazone on the genes of the~     colon~   "
228552|NCT00565461|"~     To evaluate the immune responses achieved following self-administered heat-labile enterotoxin~     of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses~     achieved by clinician-administered vaccination.~   "
228395|NCT00567580|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause~     the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide,~     and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by~     the body. It is not yet known which regimen of radiation therapy with or without~     androgen-deprivation therapy is more effective for prostate cancer.~      PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how~     well it works compared with short-term androgen deprivation therapy given together with~     pelvic lymph node radiation therapy with or without prostate radiation therapy in treating~     patients with a rising PSA after surgery for prostate cancer.~   "
228396|NCT00567567|"~     This randomized phase III trial compares two different high-dose myeloablative chemotherapy~     regimens followed by autologous stem cell transplant as consolidation treatment of younger~     patients with high-risk neuroblastoma. All patients receive the same 6 cycles of initial~     multi-agent chemotherapy induction regimen. Peripheral blood stem cells are collected after~     the 2nd cycle of chemotherapy. Drugs used in chemotherapy work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     combination chemotherapy before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed. Patients underwent resection of their primary tumor~     mass after 5 cycles of chemotherapy. Those patients without progressive disease at completion~     of induction therapy who has sufficient stem cells collected and had adequate organ function~     were eligible to proceed to consolidation therapy. Those patients who met consolidation~     eligibility were randomized to either a single myeloablative regimen or 2 myeloablative~     regimens delivered in tandem followed by re-infusion of autologous stem cells. Patients~     received radiation therapy after recovery from the assigned myeloablative therapy. It is not~     yet known which regimen of high-dose chemotherapy is more effective for patients with~     high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.~   "
228397|NCT00567554|"~     Anthracycline-taxane based chemotherapy regimens are recommended mainly by current guidelines~     for neoadjuvant application of systemic treatment. The addition of other cytotoxic agents,~     e.g. antimetabolites, vincaalkaloids, or platinum salts resulted in marginal increase in~     efficacy, but was associated also with an increase in toxicity. Recently, only the addition~     of the Her-2 antibody trastuzumab has significantly improved pathologic response rate.~      Therefore, two major strategies are followed in current research projects:~        -  To improve the selection of patients according to their tumors' sensitivity to~          chemotherapy.~        -  To implement small molecules with specific mechanism of action.~      Within the GeparQuinto trial, the first strategy is followed by:~        -  The PREDICT substudy. A gene signature specific for the response to anthracyclines and~          taxanes will be prospectively evaluated for its ability to identify patients with chance~          higher than 50% for a pCR. The results may leed to a better risk-benefit ratio for the~          use of conventional chemotherapy.~        -  Adapting further chemotherapy to the response of the tumor to the first couple of~          chemotherapy cycles. Based on the previous experience made by the GeparTrio study,~          patients not responding early have a low chance to respond with a pCR irrespective of~          the type of chemotherapy. So, if further chemotherapy is planned, therapy should be~          selected according to a favorable toxicity profile.~      The second strategy is followed by investigating in three parallel group comparisons the~     efficiency of three distinct small molecules which appear to be generally active in breast~     cancer:~        -  Bevacizumab, an inhibitor of the VEGF pathway targeting tumor neo-angiogenesis.~        -  Lapatinib, an inhibitor of the Her-1 and Her-2 receptor tyrosine kinase.~        -  RAD001 (Everolimus), an inhibitor of the mTOR molecule, a central controller of tumor~          cell growth and angiogenesis and chemosensitizer.~      Treatment for patients participating in the GeparQuinto study will be allocated according to~     the Her-2 status of the tumor as well as according to the sonographic response after the~     first 4 cycles of treatment. Experimental therapy with bevacizumab, lapatinib, and everolimus~     (RAD001) will be randomly added in distinct settings.~   "
228398|NCT00567541|"~     The goal of this research study is to investigate safety and gather initial effectiveness~     data for a new implanted device designed to treat chronic shoulder pain in chronic~     post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1 x 0.1. It is~     implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may~     reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and~     possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal~     law to investigational use.~   "
228399|NCT00567528|"~     This study was made to compare the efficacy of topical ibuprofen in gel form with oral~     ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability~     of the delivery methods~   "
228400|NCT00567515|"~     This study is to evaluate acute and long-term safety and effectiveness of Left atrial~     appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied~     in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing~     cardiac surgery with a concomitant Maze/Ablation procedure.~   "
228401|NCT00567502|"~     This is an observational safety study being conducted in Europe comparing patients taking~     Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750~     subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The~     study will collect follow up data for 5 years for each patient enrolled that will focus on~     collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions~     (SSARs).~   "
228402|NCT00567489|"~     Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal~     only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and~     Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured~     by the magnitude of change from the baseline value in the HbA1c levels.~      Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal~     only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control~     medication requirements, decreased incidence of severe hypoglycemic events requiring medical~     intervention, improved metabolic control, nutritional status, and Quality of Life. In a~     subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on~     abdominal fat and left ventricular (LV) structure and function will be assessed.~   "
228403|NCT00567476|"~     This study investigated asthma-related quality of life in Brazilian patients using~     omalizumab.~   "
228429|NCT00567125|"~     The purpose of the study was the comparative assessment of the influence of low and standard~     pressure CO2 pneumoperitoneum on the systemic inflammatory and angiogenic responses during~     the postoperative period after laparoscopic management of cholelithiasis.~   "
228430|NCT00567112|"~     A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) & oral~     compressed tablet (OCT) formulations of MK-0941-009 & to assess the effect of food on the OCT~     formulation.~   "
228682|NCT00563771|"~     To provide treatment opportunity to children and adolescent patients with hematologic~     malignancies by supplying the delayed marketed product and also to observe the efficacy and~     safety of rasburicase used in the treatment of hyperuricemia~   "
228404|NCT00567463|"~     -  The inflammatory process that leads to the development of asthma may be present before~          the onset of asthma symptoms and cause a certain degree of airway hyperresponsiveness.~          Without treatment it may induce irreversible airway structural changes that are~          associated with permanent changes in airway functions, persistent airway~          hyperresponsiveness and lead to the development of asthma symptoms.~        -  Atopic subjects with asymptomatic airway hyperresponsiveness and first degree relatives~          with a history of asthma are at higher risk to develop symptomatic asthma. Early~          treatment of airway inflammation in these predisposed subjects with  borderline  or~          mild airway hyper-responsiveness could prevent the development of asthma symptoms, and~          reduce or even normalize airway responsiveness.~        -  In very mild asthmatic subjects (bronchodilator need < thrice a week), early~          anti-inflammatory treatment can lead to  normalisation  or airway responsiveness in a~          significant number of subjects and prevent the need for subsequent regular therapy. This~          is particularly true for those showing blood/sputum eosinophilia.~      Objectives: To compare perception of bronchoconstriction, pulmonary function and airway~     inflammation in subjects with mild symptomatic asthma and asymptomatic asymptomatic airway~     hyperresponsiveness~      Methods: To compare the influence of inhaled fluticasone propionate 250 mcg/day for 3 months~     followed by 100 mcg/day for 9 months on airway inflammation and methacholine responsiveness~     in a double-blind, placebo-controlled, parallel groups study including non-smoking atopic~     subjects with mild asthma and asymptomatic airway hyperresponsiveness~   "
228405|NCT00567450|"~     In loco regional anesthesia, much more than for general anesthesia, the choice of the product~     is largely left at the discretion of the practitioner. Two categories of local anesthetics~     are distinguished according to their pharmacodynamic characteristics: products with a short~     time of installation and a short duration period, and products with a longer delay of~     installation of the sensitive and motor block, but with a long-term duration. Indeed, the~     combined use of two products pharmacodynamically different seems to be of a practical~     interest.~      This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and~     30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal~     sciatic nerve block. This is a prospective randomized double-blind study where the main~     criterion of judgment is the time of installation of a sensitive block compatible with~     surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect~     a 50% decrease of the onset of action in the combination group with a power of 90% and alpha~     to 5%, according to a previous pilot study. The secondary endpoints are the intensity and~     time of installation of the motor block, the duration of sensitive and motor block, the total~     dose of morphine administered within 48 hours, as well as its possible side effects.~   "
228406|NCT00567437|"~     One hundred patients with moderate to severe asymptomatic aortic stenosis (AS) will be asked~     to exercise on a treadmill. NT-pro-BNP levels will be drawn before and after exercise.~     Changes in NT-pro-BNP levels will be correlated to outcomes at one year. In the pilot phase~     an additional 10 control subjects without AS will be enrolled to document the control~     response of NT-pro-BNP elevations with exercise.~   "
228407|NCT00567424|"~     Study to determine drug interactions between GW273225 and the anticonvulsants valproate,~     carbamazepine or phenytoin~   "
228408|NCT00567411|"~     The purpose of the study is to compare the safety and efficacy of two drops used to lower eye~     pressure when given prior to a glaucoma laser procedure.~   "
228409|NCT00567398|"~     Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal)~     in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated~     Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the~     magnitude of change from the baseline value in the HbA1c levels.~      Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs~     Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower~     glycemic-control medication requirements, decreased incidence of severe hypoglycemic events~     requiring medical intervention, improved metabolic control, nutritional status, and Quality~     of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs~     Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be~     assessed.~   "
228410|NCT00567385|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the~     new liquid growth hormone formulation, somatropin, in children with growth hormone~     deficiency.~   "
228411|NCT00567372|"~     Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema~   "
228412|NCT00567359|"~     In this research study erlotinib will be given to eligible participants whose lung cancer has~     been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung~     cancer, and must have 1 or more of the following characteristics: be female, be of Asian or~     Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be~     examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is~     overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific~     mutations and the participant must have one of these mutations in his tumor.~      Erlotinib blocks this protein and may control tumor growth and increase survival. Previous~     research has shown that erlotinib is most effective for people who have these specific~     mutations in the EGFR.~   "
228413|NCT00567346|"~     The study is assessing efficacy and safety of three different dosage regimens of grass pollen~     sublingual immunotherapy in adult patients suffering from grass pollen related~     rhinoconjunctivitis.~   "
228425|NCT00567190|"~     This study is a Phase III, randomized, double-blind, placebo-controlled, multicenter~     international clinical trial. Participants who have HER2-positive metastatic breast cancer~     (MBC) and have not received chemotherapy or biological therapy (including approved or~     investigational tyrosine kinase/HER inhibitors or vaccines) for their metastatic disease are~     eligible for study. Participants could have received one prior hormonal treatment for MBC.~     Participants may have received systemic breast cancer treatment in the neo-adjuvant or~     adjuvant setting, provided that the participant has experienced a disease-free interval (DFI)~     of greater than or equal to (>/=) 12 months from completion of adjuvant systemic treatment~     (excluding hormonal therapy) to metastatic diagnosis. Participants may have received~     trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment.~   "
228426|NCT00567177|"~     We propose to investigate the response to Restasis, over a prolonged period of time in heavy~     computer users with dry eye disease.~   "
228414|NCT00567333|"~     This study proposes to compare two innovative treatment approaches for LBP, both of which~     focus on delivering individualized care through evidence-based, clinical care pathways.~      The primary aim of the project is to determine the relative clinical efficacy of 1)~     chiropractic care and 2) multidisciplinary, integrative care in 200 patients with sub-acute~     or chronic LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The~     primary outcome measure in this study is patient-rated back pain.~      Chiropractic care will include therapies within the professional scope of practice.~     Integrative, multidisciplinary care will include chiropractic, massage therapy, traditional~     Chinese medicine (including acupuncture), medication, cognitive behavioral therapy, exercise,~     and patient education.~      Secondary aims are to assess between group differences in frequency of symptoms, disability,~     fear avoidance behavior, self efficacy, general health, improvement, patient satisfaction,~     work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and~     providers' perceptions of treatment will be described using qualitative methods and~     cost-effectiveness and cost utility will be assessed in the short- and long-term.~      This innovative study is an exciting collaboration between an experienced and established~     team of chiropractic, conventional, and CAM professionals dedicated to advancing the care of~     pervasive and costly LBP conditions. This trial will provide new and important information~     for all health care providers and LBP patients, informing decision making and improving care~     delivery systems.~   "
228415|NCT00567320|"~     Cocaine addiction continues to be an important public health problem in the US with a~     significant cost to the individual and society. Among substance abusers, cocaine use has been~     recognized as a significant problem especially in methadone-maintenance patients. In several~     studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those~     in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer~     1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor~     clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective~     pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is~     of great importance. Unfortunately, such effective pharmacotherapies do not exist.~        1. To determine the safety and tolerability of varenicline in cocaine-using~          methadone-stabilized subjects.~        2. To determine if varenicline is efficacious in reducing cocaine-use in~          methadone-stabilized subjects.~   "
228416|NCT00567307|"~     The purpose of this pilot study is to provide data on the feasibility of conducting a large~     clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme~     inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease~     (CVD). We hypothesized that A polypill comprising the aforementioned four components would~     significantly reduce the estimated 10-year total CVD risk score with high adherence and no~     significant increase in adverse effects compared to the standard practice.~   "
228417|NCT00567294|"~     Osteoporosis is a common bone disease in older adults in which the bones become weaker and~     prone to fracture. Medications are available to slow or even stop disease progression.~     However, very few adults who are prescribed osteoporosis medications actually follow through~     with filling their prescriptions and taking the medications. Ways to improve medication use~     have not been well developed or adequately tested. The purpose of this study is to evaluate a~     telephone coaching program, with or without helpful adherence notifications to doctors, in~     improving treatment adherence in older adults who are starting an osteoporosis medication.~   "
228418|NCT00567281|"~     This trial is designed to determine if administering repetitive transcranial magnetic~     stimulation (rTMS) simultaneously to two sites in the temporal lobes, one on the left and one~     on the right, produces greater improvements in voices and other symptoms of schizophrenia~     compared to rTMS given to just one site in the temporal lobes.~   "
228419|NCT00567268|"~     The objective of the this surveillance is to collect information about 1)adverse drug~     reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of~     adverse drug reactions in this surveillance, and 3) factors considered to affect the safety~     and/or efficacy of this drug.~   "
228420|NCT00567255|"~     The purpose of this study is to determine whether the combination of naltrexone SR and~     bupropion SR is safe and effective in the treatment of obesity.~   "
228421|NCT00567242|"~     The purpose of this study is to determine if an intentional act improves treatment response~     for patients with nonfluent aphasia. The treatment involves naming pictures and saying~     members of categories. The intentional act requires initiating picture naming or category~     member trials with a left-hand movement sequence. Nonfluent aphasia is a disorder of language~     production in which patients with damage to the brain's language system have trouble~     initiating and maintaining spoken communication. All patients participating in the study take~     part in functional MRI scans to determine how treatments affect brain systems.~   "
228422|NCT00567229|"~     RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the~     cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help~     kill them or carry cancer-killing substances to them. Giving lenalidomide together with~     rituximab may be an effective treatment for multiple myeloma.~      PURPOSE: This phase II trial is studying the side effects of giving lenalidomide together~     with rituximab and to see how well it works in treating patients with recurrent or refractory~     multiple myeloma.~   "
228423|NCT00567216|"~     Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal~     injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic~     treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized~     combination of GVO and BB can further decrease the rebleeding rate.~   "
228424|NCT00567203|"~     The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose~     regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy~     for cognitive deficits in subjects with chronic symptoms of schizophrenia.~   "
228427|NCT00567164|"~     The purpose of this study is to determine whether the study drug is safe and effective.~   "
228428|NCT00567151|"~     The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM)~     co-infection in patients with smear positive pulmonary TB. To detect the NTM co-infection, we~     will perform duplex PCR targeted for mycobacterial hsp 65 gene using sputa. In addition, the~     clinical significance of this co-infection will be evaluated.~   "
228431|NCT00567099|"~     The purpose of this study is the use of magnetoencephalography or MEG (a machine that~     measures magnetic activity in your brain) and electroencephalography or EEG (a technique that~     measures electrical activity in your brain) to study how sounds are processed in individuals~     with schizophrenia prior to initiation with aripiprazole treatment and after three months of~     taking the antipsychotic medication aripiprazole.~   "
228432|NCT00567086|"~     To evaluate the effects of a single sc administration of TEZAMPANEL at one of three different~     dosage levels compared to placebo, employing traditional measures of efficacy and safety in~     the treatment of a single episode of acute migraine.~   "
228433|NCT00567073|"~     The objective is to track pregnancy outcomes in women with Pompe Disease and to follow~     infants born to women with Pompe Disease.~   "
228434|NCT00567060|"~     The purpose of this study was to explore in a more documented way the relative potential and~     efficacy of piracetam 9600 and 4800 mg daily.~   "
228435|NCT00567047|"~     This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients~     with mild, moderate or severe renal impairment and healthy volunteers.~   "
228436|NCT00567034|"~     The main purpose of this study is to determine whether the opioid antagonist naltrexone is~     helpful in ameliorating the weight gain and other adverse metabolic side effects experienced~     by schizophrenic patients taking the second generation antipsychotic (SGA) Zyprexa.~     Schizophrenics may have an altered/enhanced endogenous opioidergic drive, and because of~     this, normally painful stimuli will be sensed as less painful in schizophrenics vs. healthy~     controls. A secondary hypothesis for this study is that naltrexone augmentation of Zyprexa~     will normalize subjective pain ratings. Our tertiary objective is to examine the safety and~     tolerability of naltrexone in Zyprexa-treated patients with schizophrenia.~   "
228437|NCT00567021|"~     This PMS study had the objective to evaluate under ordinary medical care conditions the~     efficacy and tolerability of esomeprazole in patients who where treated by general~     practitioners and internists.~   "
228438|NCT00567008|"~     The purpose of this study is to determine whether varenicline (Chantix), is effective for the~     treatment of cocaine dependence.~   "
228439|NCT00566995|"~     This study will examine the effectiveness of an investigational drug called ZD6474 (also~     known as vandetanib or ZACTIMA). Vandetanib is an experimental drug that is designed to~     prevent the growth and development of new blood vessels on tumors and to prevent the direct~     growth of cancer cells. It has been tested in a number of clinical trials on adults with~     cancer, but the United States (U.S.) Food and Drug Administration has not specifically~     approved it as a cancer treatment. The purpose of this investigational study is to better~     understand how vandetanib affects humans who have kidney cancer related to von Hippel-Lindau~     (VHL) disease, and to develop tests that may improve researchers understanding of kidney~     cancer and its effects.~      Volunteers must be at least 18 years old and must have been diagnosed with kidney cancer~     related to VHL. Candidates must have a life expectancy greater than three months and must~     have at least one measurable renal tumor for study purposes. Candidates may not be receiving~     any other investigational agents or have been treated with an investigational drug within the~     past four weeks. Candidates who have had surgery, chemotherapy, or radiotherapy within the~     past four weeks will be excluded from the study. Candidates will be screened with a physical~     examination and medical history.~      During the study, participants will receive an oral dose of vandetanib once a day for 28 days~     (a treatment period known as a cycle). Participants will need to return to the National~     Institutes of Health every two weeks on the same day of the week as the first dose of~     vandetanib for a series of tests and procedures, including blood and urine tests and an~     electrocardiogram. Every 12 weeks, computerized tomography (CT) or magnetic resonance imaging~     (MRI) scans will be done to assess the size of participants tumors. Participants whose tumors~     do not grow and who do not have unacceptable side effects may continue to receive vandetanib~     to maintain the current condition, until researchers conclude the study....~   "
228440|NCT00566982|"~     The purpose of this study is to determine the efficacy and long-term safety of 60mg~     ospemifene in the treatment of VVA in postmenopausal women with intact uterus.~   "
228441|NCT00566969|"~     A total of 120 male and female opioid dependent cocaine users will participate in this study.~     This study will be a 8-week double-blind, placebo controlled study examining the~     dose-dependent effects of carvedilol (up to 50 mg/day) in methadone stabilized patients. The~     design will have two phases: 1) a four-week treatment  phase; and 2) a 4 week  taper and~     detoxification or transfer phase. Subjects will be cocaine users who are on stable doses of~     methadone (60 to 140 mg/day). Carvedilol dose will be increased from 12.5mg/day to the target~     dose of either 25 or 50 mg/day as tolerated. At the end of the treatment-phase, subjects will~     undergo detoxification from methadone over a 2 to 4-week period based on an individual's~     needs, and they will concurrently be tapered off carvedilol.~   "
228442|NCT00566956|"~     · What we know: Hydrosalpinx and IVF About 40% of patients undergoing IVF have tubal disease~     and in 25%-30% of tubal disease patients there is fluid collection within the tube;~     hydrosalpinx. The amount of fluid in the hydrosalpinx is known to increase with ovarian~     stimulation (as in IVF) and often empties into the uterine cavity. Fluid from hydrosalpinges~     has been found to be detrimental to the growth and development of mouse embryos in vitro, and~     associated with reduced levels of endometrial integrins in vivo. This could be the~     explanation of the reduced pregnancy rates after IVF in patients with tubal disease and~     hydrosalpinx compared with those with tubal disease but no hydrosalpinx. This effect was~     evidence in both fresh and frozen embryo transfer cycles. Also there was a significant~     increase in miscarriage in association with hydrosalpinx.~      The study aims to answer the question: does ultrasound-guided aspiration of ultrasound~     diagnosed hydrosalpinx at the time of egg collection improve the pregnancy rate in IVF?~   "
228443|NCT00566943|"~     The purpose of this study is to verify the performance of PSD Veritas to provide staple line~     protection during surgical procedures for obesity.~   "
228444|NCT00566930|"~     The aim of this study is to determine which of tertiary prevention spinal manipulative~     therapy (SMT) or a home exercise program is the more efficient approach to reduce pain and~     increase functional capacity, quality of life and general health condition. To do so, 60~     participants with chronic cervical pain, will be recruited and divided into 3 groups~     according to the intervention they will receive: control group, experimental group 1 who will~     receive preventive chiropractic care in the form of spinal manipulations and experimental~     group 2 will have to perform an individualized home exercise program on a daily basis. We~     hypothesize that a group of patient receiving SMT + a home exercise program will present less~     pain and functional disabilities over a 1 year period. The innovative value of this project~     is mainly related to the fact that it will generate new and potentially very useful data~     concerning the clinical significance of preventive chiropractic care. Moreover, such data~     will be beneficial to our profession as chiropractic makes a step towards prevention,~     wellness and public health.~   "
228445|NCT00566917|"~     Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic~     organs and vaginal walls to protrude. For decades, suture repair techniques have been the~     primary choice of surgical treatment when indicated.~      Traditional surgical techniques are frequently associated with unsatisfying anatomical~     recurrence rates and it is plausible that inherently weak, or damaged, pelvic floor~     supportive tissues need to be reinforced by a permanent support to avoid the high rates of~     recurrences commonly described using traditional techniques. Over the years sporadic attempts~     have been made to introduce novel surgical techniques using a variety of biomaterials with~     varying success. Despite a lack of clinical safety data, or compelling clinical evidence~     demonstrating that it improves outcomes compared to traditional suture techniques, use of~     biomaterials in pelvic reconstructive surgery has become widespread in just a few years .~      It is likely that biomaterials need to be anchored in tissues not afflicted by the disease,~     in order to provide the intended pelvic floor support. This has given rise to transvaginal~     surgical techniques using a transobturator approach passing the mesh through the arcus~     tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach.~     Short term data from concluded and on-going safety assessments of these techniques has~     provided promising results and satisfying clinical outcomes. The aim of the present study is~     to compare anterior mesh repair (PROLIFT®) with traditional suture repair in a randomised~     trial.~   "
228446|NCT00566904|"~     Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that~     causes chicken pox. Some people experience continued pain even after the shingles rash and~     blisters have healed; this pain is known as postherpetic neuralgia. The purpose of this study~     is to evaluate the effectiveness of a new topical treatment for postherpetic neuralgia in~     adults.~   "
228447|NCT00566891|"~     This single-centre study is intended to retrospectively check the safety of high-dose bolus~     of tirofiban in patients who underwent percutaneous angioplasty.~   "
228448|NCT00566878|"~     The objective is to determine if alglucosidase alfa is present in breast milk from mothers~     with Pompe Disease being treated with alglucosidase alfa and to measure breast milk~     production and composition in women with Pompe Disease who receive alglucosidase alfa.~   "
228449|NCT00566865|"~     The primary objective of this study is to determine the extent of effect of gemfibrozil on~     the pharmacokinetics and pharmacodynamics of mitiglinide.~   "
228450|NCT00566852|"~     RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiation~     therapy. It is not yet known if memantine is effective in preventing side effects caused by~     whole-brain radiation therapy.~      PURPOSE: This randomized phase III trial is studying memantine to see how well it works~     compared to a placebo in preventing side effects caused by whole-brain radiation therapy in~     patients with brain metastases from solid tumors.~   "
228451|NCT00566839|"~     Lung volume reduction surgery is effective in improving pulmonary function and quality of~     life in selected patients with severe emphysema although the morbidity of this surgical~     procedure is still considerable. Morbidity is mainly addressed to general anesthesia-related~     adverse effects and surgical trauma deriving from lung resection. Having developed an awake~     nonresectional lung volume reduction surgery technique, which is performed under sole~     thoracic epidural anesthesia, we have hypothesized that it could offer satisfactory clinical~     results and reduced morbidity rate when compared with the conventional surgical procedure.~   "
228452|NCT00566826|"~     Knee osteoarthritis is one of the most common causes of disability in older adults. Total~     knee replacement (TRK) surgery is often an effective solution when persistent pain does not~     sufficiently improve with non-surgical treatment. Although most TKR surgeries are a success,~     an estimated 15% to 30% of patients report no clinically significant improvement in function~     12 months after a TKR. This study will evaluate the effectiveness of a patient support~     program in increasing physical function after a TKR surgery.~   "
228453|NCT00566813|"~     The primary purpose of this study is to demonstrate the safety of allogeneic islet~     transplantation in type 1 diabetic patients performed at the University of Illinois at~     Chicago (UIC). The purpose is to reproduce the Edmonton protocol to demonstrate that~     pancreatic islets isolated at UIC are safe and of sufficient quality to provide reproducible~     graft function.~   "
228454|NCT00566800|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Erlotinib~     may keep esophageal cancer from forming in patients with Barrett esophagus by blocking some~     of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with~     Barrett esophagus.~   "
228455|NCT00566787|"~     RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched~     concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System~   "
228456|NCT00566774|"~     The objective of this randomized trial is to evaluate the effect of providing full~     prescription drug coverage (i.e. no co-pays, co-insurance or deductibles) for statins,~     beta-blockers, angiotensin converting enzyme inhibitors and angiotensin II receptor blockers~     to patients recently discharged from hospital after acute myocardial infarction.~   "
228457|NCT00566761|"~     Treatment of macular edema secondary to central retinal vein occlusion is more effective with~     combined therapy of bevacizumab and triamcinolone than bevacizumab alone.~   "
228458|NCT00566735|"~     The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat~     problems with thinking and memory caused by electroconvulsive therapy (ECT).~   "
228459|NCT00566722|"~     The objective of this study was to evaluate the safety and efficacy profile of Humira~     (adalimumab) in patients who had a sub-optimal response to prior systemic therapy. This~     open-label study was conducted in a patient population of moderate to severe chronic plaque~     psoriasis patients, which is an approved patient population for adalimumab.~   "
228488|NCT00566345|"~     The primary purpose of this study is to demonstrate the efficacy of an investigational~     Vero-cell derived influenza vaccine to prevent infection in an adult population with an~     influenza virus that is antigenically similar to one of the three strains in the vaccine. All~     subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of~     three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will~     be monitored for 180 days following vaccination for occurrence of adverse events. For~     determining antibody response, subjects will have one blood draw before and one blood draw 21~     days after vaccination.~   "
228460|NCT00566709|"~     Neurocritical ill patients are frequently transfused. Red blood cell transfusion (RBCT) in~     these patients has been associated with deleterious effects, including higher rates of~     nosocomial infections, multi-organ failure, and mortality. Therefore, it seems crucial to~     avoid any unnecessary RBCT.~      Most critically ill patients tolerate hemoglobin levels near 7 g/dL without an increase in~     morbidity or mortality rates. In this regard, a recent sub-analysis of TRICC trial has showed~     that TBI patients may tolerate hemoglobin levels as low as 7 g/dL, but other studies~     including neurocritical patients suggested that severe anemia may worsen clinical outcome.~     Therefore, optimal hemoglobin levels in neurocritical care patients remain largely unknown.~     Some textbooks and guidelines recommend to transfuse these patients to reach hemoglobin~     levels near to 10 g/dL, despite the lack of a solid scientific background supporting this~     target.~      Even though it has not been demonstrated, hemoglobin-based RBCT prescription could result in~     over- or under-transfusion in neurocritical patients. Alternatively, it has been suggested~     that more physiological transfusion triggers, using direct signals coming from the brain,~     will progressively replace arbitrary hemoglobin-based transfusion triggers in the~     neurocritical patients [65]. At the neurocritical units, patients are often monitored by~     using non-invasive methods, such as near infrared spectroscopy which indirectly measures~     regional cerebral oxygen saturation (rSO2). Changes in rSO2 values have been shown to~     directly correlate with changes in erythrocyte mass, thus increasing with RBCT and decreasing~     with blood losses. Moreover, rSO2 values also show a good correlation with clinical outcome~     and other variables which are often monitored in TBI patients.~      The purpose of this study is to ascertain as to whether rSO2 levels are more efficacious than~     conventional hemoglobin levels in guiding RBCT in patients admitted to a neurocritical care~     unit.~   "
228461|NCT00566696|"~     Blood and marrow stem cell transplant has improved the outcome for patients with high-risk~     hematologic malignancies. However, most patients do not have an appropriate HLA (immune type)~     matched sibling donor available and/or are unable to identify an acceptable unrelated HLA~     matched donor through the registries in a timely manner. Another option is haploidentical~     transplant using a partially matched family member donor.~      Although haploidentical transplant has proven curative in many patients, this procedure has~     been hindered by significant complications, primarily regimen-related toxicity including GVHD~     and infection due to delayed immune reconstitution. These can, in part, be due to certain~     white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize~     the body tissues of the patient (the host) are different and attack these cells. Although too~     many T cells increase the possibility of GVHD, too few may cause the recipient's immune~     system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk~     for significant infection.~      For these reasons, a primary focus for researchers is to engineer the graft to provide a T~     cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to~     facilitate immune reconstitution and graft integrity. Building on prior institutional trials,~     this study will provide patients with a haploidentical (HAPLO) graft engineered to specific T~     cell target values using the CliniMACS system. A reduced intensity, preparative regimen will~     be used in an effort to reduce regimen-related toxicity and mortality.~      The primary aim of the study is to help improve overall survival with haploidentical stem~     cell transplant in this high risk patient population by 1) limiting the complication of graft~     versus host disease (GVHD), 2) enhancing post-transplant immune reconstitution, and 3)~     reducing non-relapse mortality.~   "
228462|NCT00566683|"~     Colonoscopy is a common endoscopic procedure as an investigation of colorectal pathology.~     Different modalities of pain control have been described in the past. Propofol is a perfect~     drug for endoscopic procedure since it has the characteristic of fast onset, short half-life~     and early recovery. Its unfamiliarity and its potential cardiovascular and respiratory side~     effect make it unpopular to endoscopists. Recent reports showed propofol is safe in bolus~     titration by nurse in Caucasian in all endoscopic procedures. Our previous pilot study showed~     nurse administered propofol sedation (NAPS) is effective and safe and highly acceptable by~     Chinese patients. Here we conduct a randomized controlled study to compare the effectiveness~     of NAPS versus traditional sedation.~   "
228463|NCT00566670|"~     National Kidney Foundation guidelines recommend a dietary protein intake of 1.2 grams per~     kilogram per day (g/kg/d) in hemodialysis patients. However, it is unclear whether~     consumption of high amounts of protein in dialysis patients has beneficial or harmful~     nutritional and cardiovascular effects in this population. High protein intake might improve~     nutritional status, but it has been argued that the state of low muscle mass, small body size~     and low serum protein levels is not the result of decreased dietary intake, rather a result~     of hypercatabolism induced by metabolic acidosis, inflammation and oxidative stress.~      The specific aims of this study are to examine in a prospective cohort of hemodialysis~     patients the longitudinal associations of absolute total protein intake or dietary protein~     intake with muscle mass and arterial stiffness.~   "
228464|NCT00566657|"~     Primary objective is to demonstrate the superiority of riferminogene pecaplasmid~     (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the~     treated leg or of death from any cause, whichever comes first, in critical limb ischemia~     (CLI) patients with skin lesions.~      Secondary objectives are to evaluate:~        -  The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major~          amputation;~        -  The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;~        -  The safety of riferminogene pecaplasmid in the study population.~   "
228465|NCT00566644|"~     RATIONALE: The use of intrauterine levonorgestrel may prevent atypical endometrial~     hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer~     or Lynch syndrome. It is not yet known whether intrauterine levonorgestrel and observation~     are more effective than observation alone in preventing atypical endometrial hyperplasia and~     endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch~     syndrome.~      PURPOSE: This randomized phase III trial is studying intrauterine levonorgestrel and~     observation to see how well they work compared with observation alone in preventing atypical~     endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis~     colorectal cancer or Lynch syndrome.~   "
228466|NCT00566631|"~     The purpose of this study is to evaluate the tolerability, safety and treatment response of~     flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the~     body over an extended period of time) tablets in participants with acute schizophrenia~     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often~     with delusions and hallucinations, and withdrawal into the self).~   "
228467|NCT00566618|"~     The goal of this clinical research study is to find the highest tolerable dose of dasatinib~     and Zometa (zoledronic acid) that can be given in combination for the treatment of breast~     cancer that has spread to the bone. The safety and effectiveness of this combination will~     also be studied.~   "
228468|NCT00566605|"~     To compare the early visual results and postoperative recovery between two groups of~     keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine~     procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.~   "
228504|NCT00566111|"~     We aim to study the efficacy of intravenous ceftriaxone in a four-week, inpatient,~     placebo-controlled, double-blind study, as an augmentation therapy in patients with bipolar~     disorder, currently depressed, who have failed to respond to conventional treatments.~   "
246319|NCT00329069|"~     The aim of this study is to determine, whether an intensified atorvastatin therapy can~     improve monocyte function in patients with coronary artery disease and hypercholesterolemia.~   "
228469|NCT00566592|"~     Hypoglycemia is the principal barrier to the achievement of target glycemic goals in type 2~     diabetes. Alcohol consumption is very prevalent in our society and a proven cause of~     hypoglycemia. Population studies suggest that elderly, insulin requiring type 2 diabetes~     patients are particularly vulnerable to severe hypoglycemia and that this problem accounts~     for an estimated $50 million or more in healthcare costs in the USA each year. We hypothesize~     that low dose ethanol significantly increases the vulnerability to overnight hypoglycemia and~     impairs the recovery of plasma glucose in elderly, insulin requiring patients with type 2~     diabetes. Our preliminary studies suggest that low dose ethanol impairs recovery from day~     time insulin-induced hypoglycemia in type 2 diabetes patients but not in age matched healthy~     control subjects. The proposed studies will examine the effects of low dose ethanol on~     overnight glucose regulation in elderly, insulin requiring type 2 diabetes patients and will~     establish the mechanism of these impairments through a series of systematic evaluations.~     Specifically, these studies will document suppression of the dawn phenomenon by ethanol,~     and/or exacerbation of a deficient counterregulatory response to hypoglycemia during sleep,~     especially growth hormone. Specific mechanisms for the suppression of growth hormone to be~     examined include that evening ethanol (3) inhibits peak overnight ghrelin secretion and/or~     (4) reduces pituitary sensitivity to GHRH. Additionally, these studies will characterize (5)~     the dose response characteristics of ethanol on overnight glucose homeostasis and will (6)~     carefully evaluate the effect of the timing of ethanol administration in relation to meal~     ingestion on overnight hypoglycemic vulnerability. To address these aims, we will assess the~     effect of moderate doses of orally administered ethanol or placebo on overnight growth~     hormone release, ghrelin, total IGF-1, free IGF-1, insulin-like growth factor binding protein~     1 (IGFBP-1) concentrations, glucose production and other parameters of glucose homeostasis~     among elderly control subjects versus elderly, insulin requiring subjects with type 2~     diabetes. These important studies will provide a scientific basis for the prevention of~     overnight hypoglycemia (and the attendant cost savings) by providing mechanistic insights~     into the causes of nocturnal hypoglycemia.~   "
228470|NCT00566579|"~     Persistent human papillomavirus (HPV) infections is the single necessary cause of cervical~     cancer. Cervical cancer is still the major health problem in the developing countries. It has~     been the first rank women's cancer in Thailand for many decades. Approximately 10-20% of Thai~     women have the high-risk HPV (HR-HPV) infections in their cervices. This will frequently lead~     to low-grade squamous intraepithelial lesions (LSILs) (10%), high-grade squamous~     intraepithelial lesions (HSILs) (0.8%), and finally, cervical cancers (0.16%) within 10-20~     years. The treatment options for LSILs are either observation or ablative surgery. However,~     in our institute, cryotherapy, which is the one of ablative surgery, is more frequently used~     to comfort our women. It is not only effective but safe with only minimal side effects;~     watery leukorrhea for 2-4 weeks, and local cervical infection not more than 1%.~     Contraindication to this procedure are active cervical infection, lesion of 2 mm-larger than~     probe, lesion inside cervical os and suspected cervical cancer. Additionally, in developing~     countries such as Thailand, this treatment is safe, acceptable, feasible and effective.~     Patients with LSILs could also have this treatment in some rural area from the 10-days~     trained nurses. Fortunately, recent reports showed that cryotherapy has abilities not only in~     clearing LSILs but also clearing the HPV infections, its necessary cause. However, there are~     no randomized controlled trial compared its clearing ability between observation and~     cryotherapy. Therefore, a randomized controlled trial is needed to demonstrate that. Findings~     from this trial will contribute enormously to older women who already get infected by HPV.~     Aside from preventing cervical cancer in treated woman, cryotherapy could also give her~     relief from worrying about having a time-bomb like HPV infection in her cervix.~   "
228471|NCT00566566|"~     Background: Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It~     accounts for 25% of all childhood cancers. Peak incidence occurs between 2 to 5 years of age.~     Modern treatment regimens have improved cure rates from virtually zero (in the 1950's) to~     current overall survival rates of approximately 80%.The high survival rates have introduced~     us to novel medical problems as a consequences of the different treatment regimens. No single~     treatment modality exists today but rather several treatment protocols are accepted~     worldwide. As such, the population of the childhood ALL survivors differ in their toxic~     exposure: cranial & spinal radiotherapy, intrathecal and/or systemic chemotherapy and bone~     marrow transplantation .As the survival rates grow, there are more young adult ALL survivors~     worldwide susceptible to these late effects of treatment.~      Numerous reports have pointed out that this particular group is at increased risk to develop~     cardiovascular disease (CVD) and diabetes (MS). The metabolic syndrome, i.e hypertension,~     dyslipidemia, impaired glucose metabolism and obesity, occurs at a younger age than the~     general population.~      Adipocytokines, mediators secreted by adipose tissue, play an important role in the~     regulation of carbohydrates and lipid metabolism.Changes in serum adipokine levels precede~     the clinical symptoms.~      We aim to identify and assess prevalence of the MS in ALL survivors. We aim to characterize~     the population at risk to develop DM and CVD prior to overt clinical disease.~     Characterization will be done by measuring serum adipocytokines and inflammatory cytokine~     profiles .Biochemical characterization of the group at risk will enable us to intervene in~     the preventive stage in the future.~   "
228472|NCT00566553|"~     The role of estrogens in the pathogenesis of breast cancer has been well documented. This has~     led to the development of Anti-Estrogens (selective estrogens receptor modulators and~     Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents,~     however, have significant side effects, which are not acceptable to many healthy high-risk~     women. There is preliminary evidence that grape seed extract acts as natural aromatase~     inhibitor (1). This study has the potential to quantify the effectiveness of a natural~     substance that mimics the action of pharmaceutical aromatase inhibitors.~   "
228473|NCT00566540|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination~     chemotherapy together with radiation therapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed. Giving these treatments after~     surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving cisplatin and paclitaxel together~     with radiation therapy and surgery works in treating patients with advanced cancer of the~     oral cavity, oropharynx, or hypopharynx that can be removed by surgery.~   "
228474|NCT00566527|"~     The primary study objectives are:~        -  To demonstrate that a 2-dose regimen of ProQuad® manufactured with recombinant Human~          Albumin (rHA) administered at a 3-month interval to healthy children of 11 months of age~          at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at~          the time of Dose 1.~        -  To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval~          to healthy children of 9 months of age at the time of Dose 1 is as immunogenic as in~          healthy children of 12 months of age at the time of Dose 1.~        -  To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval~          to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is~          well-tolerated compared to children of 12 months of age at the time of Dose 1.~      The first primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a~     3-month interval to children of 11 months of age, would be non-inferior in terms of antibody~     response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the~     same regimen in children of 12 months of age at the time of Dose 1.~      If the first primary hypothesis was demonstrated, the second primary hypothesis was that a~     2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 9 months of~     age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella,~     and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age~     at the time of Dose 1.~      The secondary study objectives are:~        -  To describe the antibody titres to measles, mumps, rubella and varicella at Day 42~          following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9~          months of age.~        -  To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to~          healthy children from 9 months of age.~   "
228475|NCT00566514|"~     The purose of this research study is to determine the potential benefit of D-ribose, a~     nutritional supplement (a sugar), versus a placebo (another sugar) in people with~     fibromyalgia.~   "
228476|NCT00566501|"~     The purpose of this study is to evaluate the safety and efficacy of long-term administration~     of 23 mg donepezil sustained release (SR) in patients with moderate to severe Alzheimer's~     disease. Patients who complete study E2020-G000-326 with no ongoing serious adverse events~     (SAEs) and no serious adverse drug reactions will be eligible to enter the open-label~     extension study.~   "
228477|NCT00566488|"~     This study has three primary purposes: to assess parathyroid function after parathyroid~     transplantation in infants with Complete DiGeorge syndrome; to assess immune function~     development after transplantation; and, to assess safety and tolerability of the procedures.~     This is a Phase 1, single site, open, non-randomized clinical protocol. Enrollment is closed~     and study intervention is complete for all enrolled subjects; but subjects continue for~     observation and follow-up. Subjects under 2 years old with complete DiGeorge syndrome~     (atypical or typical) received thymus transplantation. Subjects received pre-transplant~     immune suppression with rabbit anti-human-thymocyte-globulin. Subjects with~     hypoparathyroidism and an eligible parental donor received thymus and parental parathyroid~     transplantation. A primary hypothesis: Thymus/Parathyroid transplant subjects will need less~     calcium and/or calcitriol supplementation at 1 year post-transplant as compared to historical~     controls.~   "
228478|NCT00566475|"~     The purpose of this study is to determine if using school-based telemedicine for diabetes~     support and education in students with type 1 diabetes in grades K-8 can lead to improvement~     in control of diabetes and improved satisfaction of all caregivers.~   "
228479|NCT00566462|"~     This is a two-arm, double-blind, placebo-controlled study.~   "
228480|NCT00566449|"~     The purpose of this study is to evaluate the safety and effectiveness of JNJ-31001074~     compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD).~   "
228481|NCT00566436|"~     The objective of this study is to compare remote superficial femoral artery endarterectomy~     with suprageniculate bypass surgery in the treatment of long occlusions of the superficial~     femoral artery. The study hypothesis is that patency rates are comparable and therefore the~     minimal invasive remote superficial femoral artery endarterectomy can be considered in~     patients presenting with a long occlusion of the superficial femoral artery.~   "
228482|NCT00566423|"~     The investigators hypothesize that baseline plasma brain natriuretic peptide (BNP) and~     migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH~     and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post~     exercise.~   "
228483|NCT00566410|"~     Dichloroacetate (DCA) is a small molecule that has been used for years to treat lactic~     acidosis and rare metabolic disorders in humans. Further testing now shows that it may~     suppress the growth of human cancer cells. Tests of DCA on human cells cultured outside of~     the body found that it killed lung, breast, and brain cancer cells, without affecting human~     normal cells. Tumors in rats that were infected with human tumors also shrank considerably.~     Most cancers are characterized by a resistance to apoptosis (cell death that removes abnormal~     cells) that makes them more likely to grow as well as be resistant to most cancer treatments.~     Plus, many current cancer treatments kill both cancerous and healthy cells and are highly~     toxic. DCA works by reversing the damage to the mitochondria that is present in cancer cells,~     thus reactivating the apoptosis (cell death) mechanism in them. The result is the death of~     the cancer cells. This mitochondrial reactivation presents an entirely new approach to~     treating cancer.~      DCA is known to be relatively well tolerated with few significant side effects and its~     selectivity, effectiveness and ease of delivery (oral) make it an attractive opportunity. It~     is hoped that one day this treatment may become a safe and effective treatment, either along~     or in conjunction with other treatments, for many forms of cancer.~   "
228484|NCT00566397|"~     The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in~     participants with mild to moderate Alzheimer's disease.~   "
228485|NCT00566384|"~     The purpose of the study is to evaluate the effectiveness of the study drug on the libido~     (sexual desire) of women who are taking oral contraceptives and who have experienced libido~     reductions as a side-effect of this contraceptive method The hypothesis is that there is~     superiority in the change in sexual desire and arousal component scores of the FSFI~     questionnaire from baseline to cycle 6 of the treatment with the study drug as compared to~     Placebo.~   "
228486|NCT00566371|"~     This study is a single site, double-blind, randomized, placebo-controlled parallel group~     design. this study is designed to directly examine the efficacy of a single daily dose of~     atomoxetine taken in the morning in alleviating sleep initiation insomnia in children with~     ADHD. Primary outcome measures are sleep parameters, specifically mean sleep onset latency~     (time of onset to persistent sleep), as measured by actigraphy/sleep diary, and parent and~     child-reported evening settling difficulties, as measured on the evening subscale items of~     the parent and child versions of the DPREMB-R. Secondary outcome measures include: additional~     actigraphic sleep parameters (night wakings, sleep duration, and sleep efficiency), daytime~     sleepiness (Pediatric Daytime Sleepiness Scale, sleepiness visual analogue scale (VAS), and~     morning behaviors on the DPREMB-R); ADHD symptom improvement (ADHD-RS, parent version;~     provider-completed CGI); a neurocognitive measure of attention and impulsivity (CPT);~     executive functions (Brown ADD Scale for Children) and functional outcomes/quality of life~     (CHQ).~   "
228487|NCT00566358|"~     Diabetes reversion is observed after bariatric surgeries even before significant weight loss~     could explain it, mainly in predominantly malabsorptive procedures (98,9% for biliopancreatic~     diversion or duodenal switch), followed by those combining malabsorption and gastric~     restriction (83,7% for Roux-en-Y gastric bypass). Changes in the hormonal communication~     between the digestive system and the pancreas would explain the antidiabetogenic role of the~     surgery, so this effect could be obtained in nonobese, diabetic individuals.~      In order to try this hypothesis, RUBINO and MARESCAUX (2004) studied the gastrojejunal bypass~     (duodenal exclusion)in an mouse model of diabetes without obesity. In their technique the~     stomach volume is kept intact, maintaining the caloric ingestion and the weight of the~     animals. There was a fast improvement of diabetes, independent of diet and weight, without~     the potential nutritional deprivations commonly seen in the bariatric surgery like iron and~     vitamin deficiency.~      This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after~     duodenal exclusion surgery in human non-obese, diabetic volunteers and known insulin~     secretion capacity, by the method of standardized meal stimulus. It is expected to be~     secondary to changes in the gastrointestinal hormones that stimulate insulin secretion~     (incretins).~      The knowledge about the clinical outcomes of this technique in humans and the description of~     the secretion pattern of gastrointestinal hormones after the surgery may contribute to the~     implementation of this surgery as a new therapeutic option for overweight (non-obese)~     diabetic patients.~   "
228489|NCT00566332|"~     Waldenström's macroglobulinaemia (WM) is a lymphoproliferative disorder characterized by a~     monoclonal IgM paraprotein and morphological evidence of lymphoplasmacytic lymphoma: the~     cells are IgM+, IgD+, CD19+ and CD20+ but usually CD5-, CD10- and CD23-. The treatment~     efficacy is difficult to assess because of the lack of clear diagnostic criteria , good~     response criteria, and of randomized trials.~      The actual treatment is Chlorambucil, an alkylating agent. A purine analogue such as~     Fludarabine has proven its efficacy on 30 % to 80 % as first line therapy~      This study is a phase II b open, prospective, international multicenter trial (England, Dr~     Johnson, Dr Catovsky, Australia: Dr Seymour) promoted by the French Cooperative Group on~     Chronic Lymphoid Leukemia in untreated WM, or closely related disorders ( Lymphoplasmacytic~     lymphoma or splenic marginal zone lymphoma). 366 patients must be included, among them 180~     patients in France. Patients will be stratified according to the lymphoproliferative~     disorder.~      The patients will receive Chlorambucil by oral route for 10 days every 28 days (12 cycles) (8~     MG/M², 6 MG/M² if patient is more than 75 years old) or Fludarabine by oral route for 5 days~     every 28 days (6 cycles) (40MG/M², 30 MG/M² if patient is more than 75 years old).~      The primary objective is to compare the efficacy (response rate) of Chlorambucil to~     Fludarabine in previously untreated patients. The secondary objectives are the duration of~     response, the improvement of hematological parameters, the toxicity, the quality of life, the~     event free survival and the overall survival.~   "
228490|NCT00566319|"~     This study is a three-armed randomised controlled trial that aims to determine the effect of~     a structured educational programme on physical activity levels and glucose tolerance in~     individuals with impaired glucose tolerance (IGT). The educational programme is designed to~     promote physical activity by targeting perceptions and knowledge of IGT, exercise~     self-efficacy, and self-regulatory skills. The study will also investigate whether the~     effectiveness of the educational programme at promoting self-regulatory skills and physical~     activity is enhanced by the inclusion of a pedometer and personalised step/day goals.~   "
228491|NCT00566306|"~     The aim of this study is to 1) test the efficacy of PHMG-based disinfectant against C.~     difficile spores, 2) test whether it reduces the incidence of C. difficile associated disease~     (CDAD) and 3) evaluate cost.~   "
228492|NCT00566280|"~     The purpose of this study is to evaluate molecular breast imaging in the workup of patients~     with a history of bloody nipple discharge, not reproducible in the office who have a negative~     clinical breast examination, and a negative diagnostic mammogram and breast ultrasound.~   "
228493|NCT00566267|"~     People who follow a low-carbohydrate diet typically experience a decrease in triglycerides~     and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients~     may require lipid-lowering therapy. Statins may not be the most effective strategy for~     patients on this diet, since they typically consume a greater amount of saturated fat and~     cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We~     hypothesize that patients following a low carbohydrate diet would experience a significantly~     greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in~     the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg~     alone.~   "
228494|NCT00566254|"~     The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.~   "
228495|NCT00566241|"~     28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and~     composition in adults with cystic fibrosis.~   "
228496|NCT00566228|"~     RATIONALE: It is not yet known which method of stem cell collection is best for patients~     undergoing an autologous stem cell transplant.~      PURPOSE: This randomized phase III trial is comparing two different methods of collecting~     stem cells in patients undergoing stem cell transplant for diffuse large cell lymphoma.~   "
228497|NCT00566215|"~     Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and~     Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study~     in human volunteers with type 2 diabetes and overweight (non-obese). The surgery is a~     duodenal exclusion in wich the stomach volume is kept intact. We observed improvement of~     glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn~     or significantly lowered.~      Further improvement of diabetes could be achieved by intervention in insulin resistance,~     another factor of diabetes pathophysiology. As that factor is related to visceral fat, we~     hypothesize that surgical removal of the major omentum, a great component of central~     adiposity, could beneficial .~      This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after~     duodenal exclusion surgery plus total omentectomy, by the method of standardized meal~     stimulus and insulin tolerance test, in human non-obese volunteers with diabetes type 2 and~     known insulin secretion capacity.~      The previously studied volunteers submitted to duodenal exclusion without omentectomy will be~     the control group.~   "
228498|NCT00566202|"~     The purpose of this study is to evaluate the safety and effectiveness of JNJ-18038683~     compared to escitalopram and placebo in patients with moderate to severe depression.~   "
228499|NCT00566189|"~     Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80%~     (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases.~     The current consensus supports bariatric surgical treatment for diabetic patients with BMI as~     low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the~     surgery as well.~      This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI~     30-35) human volunteers on incretins, insulin production and sensitivity and its clinical~     (diabetic chronic complications) and metabolic impact.~   "
228500|NCT00566176|"~     RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar~     System for PV Isolation on a beating heart for the treatment of all types of atrial~     fibrillation in a sole therapy operation (not concomitant to another cardiac operation).~   "
228501|NCT00566150|"~     A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the~     effects of levetiracetam on depressive symptoms in bipolar depressed patients.~   "
228502|NCT00566137|"~     To determine sleep disturbance, pulmonary function test, 6 minute walk, echocardiogram~     abnormality, arterial blood gas, ventilation/perfusion scan of the chest in Scleroderma~     patient with Pulmonary Hypertension.~   "
228503|NCT00566124|"~     To purpose of this study is to compare the pharmacodynamic properties of insulin detemir,~     insulin glargine and NPH insulin after a single subcutaneous injection.~   "
228505|NCT00566098|"~     RATIONALE: Activating white blood cells in the laboratory may help them kill more cancer~     cells when they are put back in the body. This may be an effective treatment for patients~     undergoing a stem cell transplant for multiple myeloma.~      PURPOSE: This phase I/II trial is studying the side effects of activated white blood cells~     and to see how well they work in treating patients who are undergoing a stem cell transplant~     for newly diagnosed stage II or stage III multiple myeloma.~   "
228506|NCT00566085|"~     Molecular Breast Imaging is a highly promising novel methodology for breast cancer detection.~     Preliminary patient studies with our dual-detector system indicate that this system is~     capable of reliably detecting very small (5-10 mm) malignant lesions in the breast. Besides~     the usefulness of Molecular Breast Imaging for tumor detection, we speculate that tumor~     uptake and washout may be predictors to response to neoadjuvant therapy for patients with the~     diagnosis of breast cancer. We propose that in patients with breast cancer who undergo~     neoadjuvant chemotherapy or neoadjuvant hormone therapy that molecular breast imaging is an~     accurate test for assessing response rate to neoadjuvant therapy.~   "
228507|NCT00566072|"~     21 patients were randomised to receive instructions and coaching or no intervention on the~     use and intake of ganciclovir. Intake of medication was measured by an electronic pill box.~     The duration of the study was 100 days.~   "
228508|NCT00566059|"~     Patients planned for elective conventional coronary angiography will undergo CT coronary~     angiography (Dual Source CT) in order to assess the correlation of stenosis detection and~     therapeutic advice between conventional and CT coronary angiography. We hypothesize that~     their is a good correlation between conventional and CT coronary angiography for stenosis~     detection and therapeutic advice.~   "
228509|NCT00566046|"~     Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two~     types of seizures are usually identified: early seizures during the week following the trauma~     and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early~     seizures but no treatment has demonstrated any preventive effect against late epilepsy.~     Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients~     and has pharmacologic properties that could also be interesting for the prevention of~     post-traumatic epilepsy.~   "
228510|NCT00566033|"~     Test whether the intensive intervention improves renal and cardiovascular outcomes in~     patients with chronic renal insufficiency.~      Test whether a multi-method intensive intervention including clinical Audit improves~     adherence to a series of quality indicators relevant to hypertension control, proteinuria,~     treatment of dyslipidemia, anemia, calcium and phosphate alterations in patients with chronic~     renal insufficiency.~   "
228511|NCT00566020|"~     This study is planned to assess the long-term safety of lamotrigine in Japanese patients with~     bipolar I disorder who will continue into the 52-week extension upon completion of a~     double-blind comparative study (Study No.: SCA104779 (NCT00550407)), i.e. the patients who~     receive the addition of any additional treatment to intervene in a mood episode in the~     double-blind phase or the patients completing the double-blind phase.~   "
228512|NCT00566007|"~     The purpose of this study is to assess the efficacy (vs. placebo) of ozone infiltration and~     its effectiveness in comparison with micro discectomy in the treatment of lumbar herniated~     disc with criteria for surgery.~   "
228513|NCT00565994|"~     We hope to study components within the blood that may predict success, failure or other~     associated complications in relation to the type of vascular access being used.~   "
228514|NCT00565981|"~     Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4~     cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg~     alemtuzumab s.c. in patients with B-CLL disease in 1st and 2nd relapse after any primary~     treatment or with disease refractory to any therapy in 1st or 2nd line (including~     Fludarabine, ). This regimen is preceded by an escalation phase with 3-10-30 mg of~     alemtuzumab s.c.~      After the first phase (completed treatment of 7 patients) an interim analysis of safety and~     efficacy will be performed. In case of a sufficient risk benefit assessment followed by the~     enrollment of further 21 patients. Final analysis of safety and preliminary efficacy will be~     based on all patients enrolled.~   "
228515|NCT00565968|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as melphalan, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Sorafenib may also make tumor cells more~     sensitive to melphalan. Giving sorafenib together with an isolated limb infusion of melphalan~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when~     given together with an isolated limb infusion of melphalan in treating patients with stage~     III melanoma of the arm or leg.~   "
228516|NCT00565955|"~     Available evidences show a role of oral montelukast in acute asthma. Safety of oral~     montelukast is well established in children, as evidenced by use of oral montelukast in long~     term management of asthma.~      Therefore, the investigators planned this study to see the effect of oral montelukast as add~     on therapy to standard treatment in acute moderate to severe asthma in children between 5-15~     years of age.~      HYPOTHESIS:~      Addition of single dose of oral montelukast to standard therapy in acute moderate to severe~     asthma in children aged 5-15 years will reduce the modified pulmonary index score to less~     than 9 in 90% children compared to 70% in children receiving a placebo.~   "
228527|NCT00565799|"~     PROTOCOL SUMMARY~      Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1.~     Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3)~     plasma markers of inflammation We hypothesize that removal of omental fat increases insulin~     sensitivity and pancreatic sensitivity to glucose, and decreases systemic inflammation.~      Aim 2. Identify genes and proteins in adipocytes from obese patients that affect clinical~     presentation versus those that are affected by obesity for future study.~      We hypothesize that the genetic samples will help us to identify genes and proteins in~     adipocytes from obese patients that affect clinical presentation versus those that are~     affected by obesity and help us to design future obesity genetic studies.~      Total Enrollment Number: 30 patients who are scheduled to undergo bariatric surgery for~     weight loss at New York University Medical Center will be invited to participate in this~     study. Subjects will be randomly assigned, by using a computer-generated randomization~     scheme, in a single-blind fashion to either the omentectomy (n=15) or control group (n=15).~   "
228517|NCT00565942|"~     Research over the last years have reported an increased popularity of complementary therapies~     (CTs) and an integration of CTs into mainstream medical settings, health care organizations~     and insurance plans. These trends may present both new challenges and new opportunities for~     health care provision. In Sweden and elsewhere, major challenges include the great variety~     and quality of CT provision within health care and a lack of national and international~     recommendations of how integrations of CTs with conventional care should be modelled, i.e.~     lack of conceptual models for delivering integrative medicine (IM). This may partly be a~     result of a scarce evidence base in support of IM provision within public health care~     services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains~     largely unknown whether comprehensive models of IM are clinically or cost effectively~     different from conventional care provision.~      Back and neck pain are costly, conventionally managed in primary care and two of the most~     common conditions treated by CTs. We have developed a comprehensive collaborative consensus~     model for IM adapted to Swedish primary care. The aim of this pilot study is to explore if~     the developed IM model will help patients with back/neck pain better than usual primary care~     management, i.e. to test the hypothesis that IM would be more effective than treatment as~     usual.~   "
228518|NCT00565929|"~     The purpose of this study is to compare how the body's immune system reacts to a vaccine~     against smallpox infection, called Modified Vaccinia Ankara (MVA) and to evaluate the safety~     of this vaccine. Study participants will include 24 adults, ages 18-60 years, who have~     undergone a stem cell transplant more than 2 years ago. Study procedures will include a~     physical exam, blood samples, heart activity assessments, and urine samples. Participants~     will be assigned to 1 of 2 possible study vaccine groups. The participants will receive 1 of~     2 possible vaccine doses or placebo (substance containing no medication) 28 days apart.~     Participants will make at least 8 visits to the clinic during the course of the study;~     additional visits may be needed if the participant experiences side effects from the vaccine.~     Participants may be involved in study related procedures for about 6 months.~   "
228519|NCT00565916|"~     Estrogen and progesterone are two main female sex hormones. When a woman goes through~     menopause, the body's production of estrogen and progesterone significantly decreases. Recent~     studies have shown that the breakdown of fatty acids in cardiac muscle is important in~     maintaining a healthy heart, and that estrogen may enhance this process. Also, cardiovascular~     disease (CVD) occurs more frequently in postmenopausal women than in premenopausal women.~     This study will determine in postmenopausal women whether estrogen increases the heart's~     ability to use fats as energy and whether progesterone decreases this effect.~   "
228520|NCT00565903|"~     Pleuropulmonary Blastoma (PPB) is a rare lung tumor which develops in childhood. The~     underlying genetic factors which contribute to the development and progression of PPB are not~     defined. We are working to identify the genetic factors which may contribute to the~     development of this rare tumor.~   "
228521|NCT00565890|"~     In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical~     trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first~     month of age is conducted.~   "
228522|NCT00565877|"~     Insertion of peripherally inserted central catheters (PICCs) at the bedside may result in tip~     malposition. This study was designed to evaluate whether the addition of ultrasound (US)~     inspection of the ipsilateral neck provides immediate recognition of PICCs in aberrant~     position facilitating catheter reposition prior to completion of the procedure.~   "
228523|NCT00565864|"~     Patients with hypothyroidism are routinely treated with thyroid hormone (l-thyroxine) for~     replacement therapy. Physicians monitor the thyroid hormone dose by measuring a thyroid~     stimulating hormone (TSH) level in the blood, with the goal of a normal level. However,~     recent data suggest that the normal TSH range is too broad, and that patients may still~     have symptoms if their TSH levels are at the top or bottom part of the normal range.~      To study this issue, it is useful to address issues such as general health status,~     psychological symptoms, mood, memory, and metabolic status, since thyroid hormone has major~     effects on the brain adn metabolism, and since patients with treated hypothyroidism often~     have symptoms related to these areas.~      In the present study, otherwise healthy subjects with treated hypothyroidism, ages 20-75~     years, will be enrolled in a 7-11month study. At baseline, they will have tests of health~     status, psychological symptoms, mood, memory, body composition, and energy expenditure~     performed. Following these baseline measurements, subjects will receive either their usual~     doses of l-thyroxine, or a slightly higher or lower dose. The doses will be chosen to try to~     achieve either a low-normal TSH level, a high-normal TSH level, or a mildly elevated TSH~     level. Which target TSH the patient is assigned will be determined randomly, and neither the~     subject nor the study contacts will know which dose the patient is receiving. Subjects will~     be seen every 6 weeks during the study for brief visits to make sure they are not having any~     side effects, and to adjust the l-thyroxine doses if the TSH has not yet reached the target~     range. At the 24-week visit (end of study), the subjects will undergo the same tests that~     they had on the baseline visit.~      Results from the study will be examined to see if minor changes in TSH or other thyroid~     hormone levels cause changes in any of the outcomes, and if the degree of TSH change~     correlates with the degree of outcome changes. These results may help physicians caring for~     patients with thyroid disease better determine the optimal dose of thyroid hormone for each~     patient.~   "
228524|NCT00565851|"~     This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride~     when given together with or without bevacizumab after surgery to see how well it works in~     treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that~     has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine~     hydrochloride work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal~     antibodies, such as bevacizumab, may block tumor growth in different ways by targeting~     certain cells. It is not yet known whether combination chemotherapy is more effective when~     given with or without bevacizumab after surgery in treating patients with ovarian,~     epithelial, primary peritoneal, or fallopian tube cancer.~   "
228525|NCT00565838|"~     The objective of the study was to evaluate the impact AFS and TVT procedures on~     quality-of-life in incontinent women.~   "
228526|NCT00565812|"~     The objective of this 2-year study is to evaluate the safety, tolerability and disease~     modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in~     overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be~     evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment~     of the study knee as the primary endpoint.~   "
228537|NCT00565669|"~     The purpose of this study is to evaluate the efficacy of Blink Tears and Systane used~     concomitantly with topical cyclosporine for the treatment of dry eye.~   "
228700|NCT00563511|"~     The purpose of this proposed RCT is to test (a) the effectiveness of smoking cessation~     intervention (counseling and NRT) among patients with ED; and (b) the effectiveness of~     adherence intervention (ADIN) to increase adherence to NRT use in order to increase quit~     rate.~   "
228528|NCT00565786|"~     The purpose of this prospective clinical data-collection is to document the performance,~     clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will~     be collated and used as a part of Biomet's post-market surveillance system and to provide~     feedback to designing engineers, support marketing efforts, and answer potential questions~     from reimbursement agencies.~      Inclusion/exclusion criteria are identical to those indications and contraindications stated~     in the FDA approved labeling for the device in 510(k) K926107 and 510(k) K043051. Surgical~     techniques and patient care are to be standard for the surgeons participating in the~     protocol.~   "
228529|NCT00565773|"~     Acute rejection is a common problem after a kidney transplant. Rejection can occur when the~     kidney recipient's immune system tries to attack (or reject) the new kidney. Rejection~     typically most often develops in the first few months after a transplant.~      This single center study will seek to determine if a new combination of anti-rejection~     medications, including the recently FDA approved drug called Belatacept, is better than the~     current standard anti-rejection drug regimen at preventing rejection. Also to be determined~     will be whether the new combination of drugs will allow participants to wean off their oral~     anti-rejection medications over time.~      This study will test the safety and effectiveness of a new investigational drug combination~     using alemtuzumab, belatacept, and sirolimus when given with or without donor bone marrow.~      This combination of medicines has not been tested before in humans. Alemtuzumab (Campath) is~     approved for use in some types of white blood cell cancers, but is considered investigational~     in transplant patients. Belatacept is now FDA approved and is being studied in transplant~     patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with~     belatacept and alemtuzumab is investigational.~      In the initial 20 subjects enrolled in the study, half tested whether an infusion of bone~     marrow from the kidney donor would improve the effect of these drugs. This bone marrow~     infusion was also considered investigational.~      Enrollment of 20 additional subjects was begun in January, 2013. The donor bone marrow~     infusion has been eliminated. Enrollment was open to primary living and deceased donor kidney~     recipients. Enrollment is closed as of 8/12/2014.~      Funding Source - FDA OOPD~   "
228530|NCT00565760|"~     This is a Phase 3 double-blind, multiple dose safety extension study of Q8003 administered at~     daily doses up to 36 mg morphine/24 mg oxycodone (Q8003 36mg/24mg) over a treatment period of~     up to 4 weeks. Patients with acute moderate to severe pain who have completed participation~     in one of the designated QRxPharma, Inc. acute pain lead-in studies will be eligible for this~     trial.~   "
228531|NCT00565747|"~     This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium~     will increase the chance of a pregnancy after in vitro fertilisation.~   "
228532|NCT00565734|"~     The primary purposes of this study are to compare anterior and posterior surgical approach in~     treatment of CSM ad to compare variations in treatment and outcomes of CSM worldwide.~   "
228533|NCT00565721|"~     This proof-of-concept study is designed to assess the ability of [18F]AH-111585 PET imaging~     to detect tumors and angiogenesis. Up to 30 evaluable subjects are planned to be included at~     up to 2 study centers in the US. Subjects are considered evaluable if they undergo~     administration of AH-111585 (18F) Injection, dynamic and static PET imaging, and tumor tissue~     acquisition. The targeted population is adult subjects at initial diagnosis or recurrence~     with tumors ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumor~     as a result of routine clinical treatment. The tumors must belong to one of the following 5~     types:~        -  High-grade glioma, including glioblastoma multiforme, anaplastic astrocytoma, and~          anaplastic oligodendroglioma~        -  Lung cancer, including small cell lung cancer and non-small cell lung cancer~        -  Head and neck (H&N) tumors, including laryngeal squamous cell carcinoma,~          well-differentiated thyroid and oral cavity carcinoma~        -  Sarcoma~        -  Melanoma~      Safety will be assessed from the rates of adverse events, changes in vital signs, changes in~     electrocardiogram (ECG) parameters, changes in physical examination findings, and changes in~     clinical laboratory findings.~      Efficacy will be assessed as the correlations between parameters derived from the PET images~     and the reference standards. The reference standards will be immunohistology for αvβ3~     integrins and other biomarkers specific for oncology and angiogenesis and from the standard~     of care imaging.~      Measures obtained from optional DCE-CT imaging may also be used to compare the uptake and~     retention of [18F]AH-111585 in tumors obtained from the dynamic PET to assess functional~     status of the vascular system of the tumor.~   "
228534|NCT00565708|"~     We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in~     patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in~     this patient population over placebo control. If indeed found to be beneficial, because~     aspirin is cheap and easy to administer, it will positively impact the lives of many~     individuals in Asia and globally.~      STUDY OBJECTIVE~      To assess the effectiveness of Aspirin against placebo control in patients with dukes C or~     high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall~     Survival (OS)~      Primary endpoints~        -  DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer~          and rectal cancer patient sub-groups);~        -  DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer).~      Secondary endpoints~        -  Overall survival (OS) over 5 years~        -  DFS and OS in~             -  Chinese, Malay, Indian and other ethnic groups~             -  Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer~               sub-groups, individually~             -  Compliant versus non-compliant subjects~             -  PIK3CA mutated tumors (where samples are available)~   "
228535|NCT00565695|"~     The purpose of this study is to evaluate the visual outcomes and patient satisfaction after~     bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare~     it to a historical control group of patients implanted bilaterally with the spherical ReSTOR~     multifocal IOL.~   "
228536|NCT00565682|"~     To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the~     already known effect when administered after such a procedure. Patient will be receiving~     either etoricoxib or the respective placebo one hour before surgery, then two hours after~     those receiving the active will receive placebo and those that received placebo will be given~     etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be~     available all the time.~   "
228538|NCT00565656|"~     The objectives of this phase II trial are to test the efficacy and tolerance of Bevacizumab~     in MDS patients with excess of marrow blasts and to evaluate the impact of Bevacizumab on~     angiogenesis and erythropoiesis.~      To limit the myelotoxicity observed in the preliminary phase II study, Bevacizumab will be~     administrated at the initial dose of 5 mg/kg.~      The primary endpoint will be response: Complete Remission (CR), Partial Remission (PR) and~     hematological improvement (HI) according to IWG criteria (see appendix 3).~      The secondary endpoints will be survival, response duration, side effects, evaluation of~     angiogenesis (bone marrow microvessel density, VEGF plasma level, VEGF mRNA expression,~     HIF-1alpha expression).~      The design of this study consists of three study periods: pre-treatment (screening),~     treatment (loading and maintenance), and follow-up. All patients will participate in the~     study for at least 12 weeks of therapy, a 4-week follow-up visit, and long-term follow-up~     unless the criteria for planned or unplanned early discontinuation are met.~   "
228539|NCT00565643|"~     A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of~     Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary~     outcome will be measurement of the extent and severity of adhesions at the time of subsequent~     cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex.,~     incision-delivery; total operative time).~   "
228540|NCT00565630|"~     The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration~     when administered as the commercially available eye drops or as a spray delivered from a~     proprietary device.~   "
228541|NCT00565617|"~     Objective: Chronic epidural cortical stimulation (ECS) involves the neurosurgical placement~     of an electric wire on the surface of the brain with intermittent activation. Over time, ECS~     modulates local and distal connected brain regions. It is being currently applied over the~     motor cortex to treat intractable pain. Because of the important role played by the medial~     prefrontal cortex in mood regulation, the goal of this study is to apply this minimally~     invasive neurostimulation modality over medial prefrontal cortex in severely ill depressed~     subjects who have failed all other attempts at treatment.~   "
228542|NCT00565604|"~     This trial is designed as a prospective, non randomized, single center clinical trial to~     determine the safety and efficacy of laser ablation of incompetent perforator veins.~      Within this clinical evaluation, fifty (50) limbs will be treated with Vari-Lase ®. A duplex~     ultrasound will verify the presence or absence of incompetent perforator veins (IPV). In~     addition, the number, diameter and location of the IPVs will be determined. Limbs with IPVs~     which measure greater than or equal to 3mm in diameter and are located superior to the foot~     and distal ankle will be considered for entry into the study.~   "
228543|NCT00565591|"~     This open label single blind study will determine the safety of albuterol sulfate dry powder~     in a novel inhaler by observing for the potential occurrence of reflex bronchial constriction~     after inhalation of increasing doses of the compound.~   "
228544|NCT00565565|"~     This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552~     in a single dose escalation design. Furthermore, this study examines the changes in~     hemodynamics after application of the test substance.42 hospitalized stable patients with~     chronic heart failure will be included. Several measurements will be performed to test how~     good the drug works and wether there are any unwanted reactions to the drug (e.g. blood~     tests, ECG, heart rate, blood pressure, adverse events). After a observation period the~     patient will be discharged from the hospital.~   "
228545|NCT00565552|"~     So far the evaluation of scar treatment was based on subjective criteria. The patient groups~     were divided into treated versus non-treated.~      In this study we use patients undergoing ear reconstruction with autologous rib cartilage.~     The thoracic scar of harvesting the rib cartilage is routinely reopened after 3 month during~     second stage of reconstruction. Therefore we have a ideal model of clinical, physiological~     and histological scar evaluation in a homologous patient group.~      All patients randomly treat one half of the scar with a silicone gel (Dermatix). The other~     half is untreated as an internal control.~   "
228546|NCT00565539|"~     Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral~     infections. The purpose of this study is to test the safety and antiviral effects of~     PEG-rIL-29 (a man-made form of IL-29) when it is given either by itself at different doses or~     in combination with the approved dose of ribavirin (an antiviral drug) to subjects with~     hepatitis C infection who have received no prior treatment for this disease or who have~     relapsed following previous treatment with PEGylated interferon alpha (PEG-IFN-α), or other~     form of IFN-α, and ribavirin.~   "
228547|NCT00565526|"~     Background:~      Sj(SqrRoot)(Delta)gren s Syndrome (SS) is an autoimmune disease that affects the glands that~     produce saliva and tears, causing dry eyes and dry mouth.~      Researchers do not know the exact cause of SS, but they believe that it may be caused by~     abnormalities in the autonomic nervous system (ANS) that stimulate these glands.~      Objectives:~      To better understand ANS function in patients with SS.~      To compare information about ANS function in healthy individuals and in patients with SS.~      Eligibility:~      Patients with Sj(SqrRoot)(Delta)gren s Syndrome who are 18 years of age and older, and who~     are not pregnant or breastfeeding.~      Participants will be asked to taper or discontinue the use of certain medications or dietary~     supplements before the ANS testing.~      Participants must be willing to discontinue the use of alcohol and tobacco 24 hours prior to~     testing.~      Design:~      The study will require one inpatient admission and/or outpatient visits to the NIH Clinical~     Center.~      The following tests and procedures will be performed:~        -  Saliva, tear, and sweat production measurements to evaluate the function of glands.~        -  Testing of changes to the cardiovascular system, including blood pressure and blood flow~          testing, and an electrocardiogram designed to evaluate hemodynamic changes controlled by~          the ANS.~        -  Testing of changes to the gastrointestinal system, including a swallowing assessment~          study, barium swallow study, and gastric emptying study designed to evaluate~          gastrointestinal function controlled by the ANS.~        -  Tests to evaluate the ANS function in response to certain drugs (edrophonium, glucagon~          and acetylcholine).~        -  Self-reported questionnaire on ANS function and emotional/psychological well-being.~      Additional procedures and tests may include the following:~        -  Blood samples.~        -  Optional skin biopsy to study sweat glands and nerve supply of the skin.~   "
228548|NCT00565513|"~     We studied prospectively the incidence of cryptorchidism in Nice area. We tightly matched~     each affected child (n=95) with 2 healthy controls (n=188) and assessed risk factors for~     cryptorchidism focussing on prenatal exposure (cord blood and maternal milk) to endocrine~     disruptors known to affect testis migration, searching for correlations with cryptorchid~     status~   "
228549|NCT00565500|"~     Study design: Single center, placebo-controlled, double blind, parallel groups. To evaluate~     the potential interaction between aspirin and ibuprofen or celecoxib in patients with~     osteoarthritis (OA) and documented stable ischemic heart disease, a total of 24 patients~     chronically treated with aspirin will be randomly assigned to one of the 3 treatment groups:~     1) celecoxib 200 mg bid; 2) ibuprofen 600 mg tid; 3) placebo.~   "
228553|NCT00565448|"~     The primary objective is to estimate the Complete Response rate of docetaxel to the~     combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in~     the Induction treatment of Nasopharyngeal Carcinoma (NPC).~      The secondary objectives are to determine:~        -  the safety of TCF in comparison to CF after induction treatment of NPC,~        -  the pharmacokinetics of docetaxel when added to CF,~        -  the Overall Response rate of TCF and CF on completion of induction and consolidation~          (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and~          CF.~   "
228554|NCT00565435|"~     Since Chiari malformation is a common disease, many patients require surgical operation to~     relieve pressure from the back portion of the skull. The purpose of this research is to~     compare two different materials that are routinely used to repair the opening in the brain~     covering during the surgery on the back portion of the skull in patients with symptomatic~     Chiari Malformation. None of the materials used in this study nor any procedures are~     experimental.~   "
228555|NCT00565422|"~     The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and~     effective in treating problematic internet use.~   "
228556|NCT00565409|"~     To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate~     with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.~   "
228557|NCT00565396|"~     The purpose of this study is to determine whether fosinopril and losartan are effective in~     the treatment of patients with Chronic Kidney Disease(CKD) stage 3.~   "
228558|NCT00565383|"~     We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the~     success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or~     epidural analgesia) during version for breech presentation increases successful fetal~     rotation and decreases the incidence of Cesarean delivery for malpresentation.~   "
228559|NCT00565370|"~     There is strong scientific rationale for exploring the role of sorafenib with capecitabine~     and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel~     signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through~     blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine~     kinases VEGF-R2 and PDGFR-beta.~   "
228560|NCT00565357|"~     The purpose of this study was to determine the effects of individual noise reduction using~     silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and~     development. The study hypothesis was that newborns who were randomized to the earplug group~     would be heavier than controls at 34 weeks post-menstrual age.~   "
228561|NCT00565344|"~     We will obtain data from the robust Agency for Healthcare Reimbursement and Quality (AHRQ)~     Healthcare Utilization Project (HCUP), as well as from the State of Tennessee. If our~     hypotheses are true, such data will provide strong evidence that Medicaid disenrollment has a~     negetive health impact on uninsured populations. The data may also provide evidence for~     increased public funding of safety-net EDs after Medicaid disenrollment.~   "
228562|NCT00565331|"~     Our standard immunosuppressive treatment after renal transplantation is a combination of~     tacrolimus, mycophenolate mofetil, and prednisolone. With this regimen the incidence of acute~     rejection within the first six months after transplantation has dropped to about 20%. The~     main challenge at present remains to improve long-term outcome by preventing chronic~     allograft nephropathy (CAN). Since acute rejection is a strong predictor of CAN, a further~     decrease in the incidence of acute rejection can improve the long-term graft survival.~     Current strategies to prevent rejection are mainly directed at alloreactive T cells.~     Recently, the attention for the role of antibodies in the pathogenesis of acute rejection has~     increased. In addition, anti-B cell therapy was shown to be effective in diseases that were~     considered to be mainly T cell driven, like rheumatoid arthritis. In the latter case it has~     been suggested that anti-B cell antibodies may impair the antigen presenting function of B~     cells. We therefore decided to investigate the effectiveness and safety of the anti-B cell~     monoclonal antibody rituximab for prophylaxis of acute rejection after renal transplantation.~      Study design: Double-blind, placebo controlled intervention study. One group receives a~     single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation, and the~     other group receives a placebo infusion.~      Primary Objective:~      To determine the incidence and severity of biopsy-confirmed acute rejection within the first~     six months after transplantation.~      Secondary Outcomes:~        -  Renal function as estimated by the endogenous creatinine clearance at 6 months~        -  Occurrence of chronic allograft nephropathy at 6 months~        -  Cumulative incidence of infections and malignancies at 6 months~        -  Medical costs during the first 6 months after transplantation~        -  Patient and graft survival~   "
228563|NCT00565318|"~     The purpose of this study is to investigate the effect of benfotiamine supplementation in~     patients with diabetic nephropathy, and to determine whether it will slow down the~     progression to end-stage renal disease (ESRD).~   "
228564|NCT00565305|"~     The purpose of this research study is to understand effects of a complementary medicine~     therapy, Healing Touch on quality of life and immunity of patients who are receiving~     treatment for breast cancer. Healing Touch is a Holistic Therapy used as an adjunct to~     medical treatment. The goal of Healing Touch is to restore energy and vitality to the body as~     a patient is receiving treatment for cancer. Treatments include light touch on specific~     points on the body as well as around the body, to increase well-being and support the body's~     ability to heal. Healing Touch has been shown to increase relaxation and well-being and to~     decrease anxiety, pain, and treatment side effects in a variety of illnesses including~     cancer. Although Healing Touch is frequently used by cancer patients along with their medical~     treatments, very little is understood about the effects of this treatment on the immune~     system. The immune system is known to be important in the body's response to fighting cancer.~     We are studying Healing Touch to help us understand whether or not these treatments are~     effective in supporting the immune system during breast cancer treatment~      Aim 1. To evaluate effects of a healing touch (HT) intervention on cellular immunity among~     early stage breast cancer patients during radiotherapy.~      Aim 2. To evaluate effects of a Healing Touch (HT) intervention on cytokines associated with~     radiation damage and acute skin reactions in early stage breast cancer patients during~     radiotherapy.~      Aim 3. To evaluate the effects of a Healing Touch intervention on fatigue and mood in early~     stage breast cancer patients during radiation treatment.~   "
228565|NCT00565292|"~     This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with~     primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed~     hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL~     cholesterol in blood) This is an early phase trial and some specific protocol information is~     in progress and not publicly available at this time. (Full information is available to trial~     participants).~   "
229055|NCT00558818|"~     A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is~     to investigate safety and efficacy of clevudine in patients chronically infected with~     hepatitis B virus, HBeAg positive or negative.~   "
228566|NCT00565279|"~     A growing body of evidence supports the hypothesis that the pathophysiology of seborrhoeic~     dermatitis has a potentially causative neurogenic inflammatory aspect. ASF1057 is a new drug~     that acts through a modulation of neurogenic inflammation through important complementary~     mechanisms of action. This study will test the efficacy and safety of ASF1057 in the~     treatment of patients with seborrhoeic dermatitis.~   "
228567|NCT00565266|"~     Typically, people with asthma are initially prescribed a low dose of inhaled corticosteroid~     (ICS) medication to control asthma symptoms. If a low dose of ICS is ineffective at~     controlling symptoms, the addition of a second controller medication is recommended. This~     study will examine the effectiveness of the medication tiotropium bromide combined with a low~     dose of ICS at maintaining asthma control in people with moderately severe asthma.~   "
228568|NCT00565253|"~     The purpose of the study is to determine if inhaled nitric oxide, a potent and selective~     pulmonary vasodilator, is beneficial in patients with acute pulmonary embolism causing~     increased right ventricular afterload.~   "
228569|NCT00565240|"~     We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives~     (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles~     in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate~     that this will provide us with information to facilitate the development of a new method for~     ovarian synchronization; a safer, more effective ovulation induction therapy; a new method~     for emergency contraception; and a greater understanding of human folliculogenesis.~   "
228570|NCT00565227|"~     Vorinostat (Suberoylanilide Hydroxamic Acid; NSC 701852) is a drug that inhibits an enzyme~     that plays a key role in the regulation of cell survival, growth, and eventual cell death,~     all of which play a role in cancer. As a result, this drug has the potential to affect a~     tumor's ability to survive. Vorinostat is the most potent drug of its kind that is currently~     under investigation in clinical trials. The primary objective of this study is to define the~     maximum safest dose of vorinostat in combination with a standard chemotherapy agent,~     docetaxel, in patients with advanced and relapsed lung, bladder, or prostate cancer.~   "
228571|NCT00565214|"~     Smoking damages the airway epithelium. The major mechanism by which this is done is by~     molecules called free radicals. Our body attempts to deal with these damaging molecules in~     two ways. One mechanism is via the presence of protective anti-oxidant vitamins and the other~     is via proteins that are produced by the body to convert free radicals to safer, less~     reactive molecules. Vitamins in our diet play a significant role in antioxidant defenses by~     directly neutralizing the damaging free-radicals and by providing co-factors to cellular~     proteins that neutralize the free radicals. This project is designed to look at the effects~     of giving individuals supplemental vitamins to see if it improves their defenses against~     oxidant insults. The investigators plan to look at the effects of these supplements over a 30~     day period and monitor the effects by measuring vitamin levels in the blood and in the lung,~     and by measuring the response of cells in the lung through the increase or decrease in~     expression of genes responsive to oxidants.~      To participate in this protocol, the research subject should first be enrolled in Weill-IRB~     protocol #0005004439 entitled Evaluation of the Lungs of Normal (Smokers, Ex-smokers,~     Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and~     Bronchial Wall Biopsy, fulfilling the inclusion/exclusion criteria of that protocol. They~     will be invited to participate in this Vitamin protocol only if they meet the additional~     inclusion/exclusion criteria of this protocol.~   "
228572|NCT00565201|"~     The present study is designed to determine the safety and effectiveness of injections of~     BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would~     do nothing) when combined with rehabilitation therapy for the improvement of active function~     tasks in post-stroke patients. Injections will be targeted to reduce common spasticity~     patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist,~     thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory~     University. Neither the doctor injecting the drug nor the subject receiving the drug will~     know if they are getting BOTOX® or saline. Which type of injection the subject receives will~     be completely randomized (like flipping a coin). All subjects will have rehabilitation~     therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits~     (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects~     will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5~     times a week, for 4 weeks. The results from this project will provide valuable data on the~     ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic~     muscles of the arm and hand after stroke. This project has the potential to increase the~     availability of effective rehabilitation techniques to patients with stroke.~   "
228573|NCT00565188|"~     Palliative care in cancer aims at alleviating the suffering of patients. A previous study in~     patients with advanced non-small-cell lung cancer showed that adenosine 5'-triphosphate (ATP)~     infusions had a favourable effect on fatigue, appetite, body weight, muscle strength,~     functional status, quality of life, and survival. Based on these promising results, the~     present study was designed 1. To evaluate whether the beneficial effects of ATP~     administration observed in patients with advanced lung cancer would also be present in~     pre-terminal cancer patients of different tumour types, and 2. To test the feasibility of~     application of ATP infusions in a home care setting.~   "
228574|NCT00565175|"~     The purpose of the study is to investigate whether blockade of the histamine H2 receptors in~     the brain will have any beneficial effect on the symptoms of subjects with schizophrenia.~   "
228575|NCT00565162|"~     To introduce initiation of glargine insulin treatment in primary care based on a patient~     education program. To show and compare feasibility of group education to individual education~     program.~   "
228576|NCT00565149|"~     This study is designed to determine the effects of dietary protein content on overfeeding.~   "
228577|NCT00565136|"~     The study purpose is to gain experience with the TOPAS system, a minimally- invasively~     delivered self-fixating mesh for the treatment of pelvic floor weakness in women with~     symptoms of moderate fecal incontinence~   "
228578|NCT00565123|"~     The aim of the study is to evaluate the clinical and microbiological efficacies of three~     times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent~     dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3~     days) in patients with bacterial conjunctivitis.~   "
228579|NCT00565110|"~     The ADAPt-C collaborative depression care model is designed to: improve depression symptom~     reduction in the intervention group over the modestly enhanced usual care group of~     low-income, predominantly Hispanic, patients with cancer who are receiving care in an urban~     public sector care system; and to improve quality of life outcomes among intervention~     patients over enhanced usual care.~   "
228580|NCT00565097|"~     To assess the efficacy of lanreotide in controling total liver volume in patients with~     polycystic livers this study will be performed. A minimum of 38 patients will be recruited~     and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other~     disease states and found to be safe and non-toxic.~   "
228581|NCT00565084|"~     The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee~     pain during a series of timed walks on a treadmill.~   "
228582|NCT00565071|"~     The purpose of this study is to compare the cost-effectiveness of treating malaria based on~     three methods of diagnosis (rapid test, microscopy and presumptive diagnosis) among patients~     attending level three government health centres located in areas of low and high transmission~     intensities in Uganda. The study hypotheses are: in both low and high transmission areas,~     cost-effectiveness of malaria treatment with Artemether-Lumefantrine will be improved by the~     adoption of rapid diagnostic tests when compared with presumptive diagnosis or microscopy;~     and the difference between the cost-effectiveness of Artemether-Lumefantrine treatment~     following rapid diagnostic test or microscopy versus presumptive diagnosis will be greatest~     in low transmission areas.~   "
228583|NCT00565058|"~     This is a Phase II trial conducted at multiple centers for evaluation of the pharmacodynamic~     activity and the overall response rate contributed by the combination agents of GTI-2040 and~     High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML).~   "
228584|NCT00565045|"~     Impaired hand function is one of the most frequently persisting consequences of stroke. The~     purpose of this study is to investigate whether two different types of treatment improve~     recovery of hand function after stroke.~   "
228585|NCT00565032|"~     Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more~     likely than their normal counterparts to have higher scores on a common postpartum depression~     screening test.~   "
228586|NCT00565019|"~     Background:~      Dupuytren's contracture is a common hand problem that causes certain fingers to bend towards~     the palm. Patients with this condition cannot perform daily activities and many are unable to~     work. It is usually treated by an operation to straighten the fingers followed by therapy if~     the angle that the fingers are bent at is large enough. However, no treatment has been able~     to completely prevent the angle from persisting.~      Objective:~      This study is designed to examine whether or not the use of a drug in combination with~     surgery will improve the angle at which the fingers are bent more than surgery alone.~      Hypothesis:~      Subjects who receive triamcinolone acetonide will have straighter fingers compared with~     subjects who only have the operation and no triamcinolone acetonide at both 3 months and 6~     months after the operation.~      Methods:~      Eligible patients interested in having the operation to treat Dupuytren's contracture will be~     asked if they would like to join the study. Subjects will be randomly placed into one of two~     groups: the steroid injection group or the control group. Subjects will have a pre-operative~     visit, the surgery, and follow-ups at 6 weeks, 3 months and 6 months. All subjects will have~     the operation, but only those in the steroid injection group will receive an injection of the~     drug. During the 6 week and 3 month follow-ups, subjects in the steroid injection group may~     receive another injection if their fingers are still bent. Angles are measured at the~     pre-operative visit and at 3 and 6 months. The change in angle from before to after and any~     differences in the groups, in time points and interactions between the two will be analyzed.~   "
228587|NCT00565006|"~     This study will investigate the influence of MK0859 on ambulatory blood pressure, and how~     safe and tolerable MK0859 is on the subjects This is an early phase trial and some specific~     protocol information is in progress and not publicly available at this time. (Full~     information is available to trial participants).~   "
228588|NCT00564993|"~     Summary:~      The investigators aim to identify markers of right ventricular dysfunction in patients with~     severe pulmonary regurgitation following repair of Tetralogy of Fallot, that allow prediction~     of the optimal timing of the replacement of the regurgitant valve. The investigators will use~     MR as a gold-standard reference for measurement of cardiac function during rest and~     dobutamine stress. The investigators will also evaluate the predictive potential of tissue~     Doppler imaging in this patient group.~      Purpose:~      To predict the optimum timing of pulmonary valve replacement for severe regurgitation in~     repaired Tetralogy of Fallot using Cardiac Magnetic resonance with dobutamine stress testing.~   "
228589|NCT00564980|"~     The purpose of this study is to evaluate two different currently accepted surgical treatments~     for UAS (ulnocarpal abutment syndrome).~      The hypothesis is that ulnar shortening osteotomy procedure will be associated with longer~     surgical time and increased complication rate when compared to the wafer procedure. It is~     unclear as to whether there will be a difference in functional outcome between the two~     groups.~   "
228590|NCT00564967|"~     Social phobia is one of the most prevalent anxiety disorders in the western world. Cognitive~     behavioural therapy (CBT) is the psychological treatment that has the largest empirical~     support. However, the availability to CBT is very limited in Sweden due to lack of therapists~     with proper training. Therefore it is important to evaluate alternative forms of treatment~     that are more time efficient. One of these methods is Internet based self-help therapy, which~     has proven to be an effective treatment for social phobia.~      To the investigator´s knowledge, no study has yet directly compared live-CBT to Internet~     therapy. The aim of the present study is to compare the effect of live CBT vs CBT delivered~     via the Internet. The study is considered to be an equivalence trial. 128 patients will be~     randomly assigned to one of the two treatment conditions. The primary outcome measure is~     Liebowitz Social Anxiety Scale (LSAS).~   "
228591|NCT00564954|"~     This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo~     during an 8-hour laboratory classroom day.~   "
228592|NCT00564941|"~     This study will evaluate the safety and efficacy of deferasirox in transfusion dependent~     Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload~   "
228593|NCT00564928|"~     To determine:~        -  Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate~          cancer.~        -  Group A - subjects who have not previously received chemotherapy~        -  Group B - sujects who have received prior chemotherapy or could not tolerate~          chemotherapy.~        -  Clinical response will be determined by PSA and radiological response~   "
228594|NCT00564915|"~     A study of the efficacy and tolerability of two different ketogenic diets in children with~     drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet~     after baseline or after further 3m control period; in addition randomised to either MCT or~     classical ketogenic diet.~   "
228595|NCT00564902|"~     To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to~     patients with early and moderate Atrophic Age Related Macular Degeneration.~   "
228596|NCT00564889|"~     RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop plasma cells from growing. Drugs used in chemotherapy, such as~     cyclophosphamide and dexamethasone, work in different ways to stop the growth of plasma~     cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide~     together with cyclophosphamide and dexamethasone may be an effective treatment for primary~     systemic amyloidosis.~      PURPOSE: This phase II trial is studying how well giving lenalidomide together with~     cyclophosphamide and dexamethasone works in treating patients with primary systemic~     amyloidosis.~   "
228597|NCT00564876|"~     Src expression has been identified in a majority of Non-Small Cell Lung Cancer (NSCLC) cell~     lines and there is preclinical evidence that Src family kinases may be important in hypoxic~     growth and angiogenesis in NSCLC. We hypothesize that the inhibition of Src pathway with~     dasatinib will demonstrate anti-tumor activity in early stage NSCLC, with a tolerable safety~     profile.~      Patients will receive dasatinib, a Src inhibitor, for 3 weeks prior to surgical resection for~     early stage NSCLC. Fresh frozen tumor tissue is needed for genomic analysis. If fresh frozen~     tumor tissue is not available from the initial diagnosis, a biopsy will be required to~     participate in this trial. A second tumor sample will be obtained at time of surgical~     resection to evaluate for changes in genomic expression profiles.~      Patients will be eligible to receive 3 months of adjuvant dasatinib therapy after completion~     of standard adjuvant therapy or after recovery from surgery if no standard adjuvant therapy~     is given, if there is evidence of neoadjuvant tumor response (radiologic and/or pathologic)~     to dasatinib.~      Many patients who present with NSCLC are active smokers. Patients who are smoking up until~     the time of their surgery experience increased peri-operative complications compared to~     patients who have not smoked cigarettes immediately prior to surgery. While this trial will~     not be limited to active smokers, the period of smoking cessation prior to surgery is an~     attractive window of opportunity during which the potentially active novel anticancer therapy~     dasatinib can be offered to the patient.~   "
228598|NCT00564863|"~     This will be a strain and dose-finding study in which CS19-ETEC strain WS0115A will be~     administered at a starting inoculum of 5 x 108 colony forming units (cfu) to 5 subjects as~     the initial step to establish a human disease model. If an 80% attack rate (AR) for~     predefined diarrheal disease is achieved without high output diarrhea, the same inoculum will~     be given to 5 - 10 more subjects for confirmation of AR. If an 80% AR is not achieved, AR and~     severity of disease will be evaluated to determine if the dose should be increased. The same~     sequence may be conducted with DS26-1 as necessary. If the WS0115A strain causes high output~     diarrhea, the dose will be adjusted down and further dose characterization continued. An~     iterative process will be used to select the optimal strain and dose with each step reviewed~     and approved by the medical monitor.~   "
228599|NCT00564850|"~     The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the~     delay of premature onset of puberty in girls less than 9 years and boys less than 10 years.~     This is measured by assessing the proportion of children who have a suppressed Luteinizing~     Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after~     injection with triptorelin 11.25 mg.~   "
228600|NCT00564837|"~     This study was designed to determine whether or not there were any differences in knee range~     of motion, both statically and during gait, sagittal plane knee laxity, and quadriceps and~     hamstrings strength in patients three months post-ACL reconstruction with a bone-patellar~     tendon-bone autograft based on their performance of a primarily home based rehabilitation~     program or a standard physiotherapy-supervised program.~   "
228601|NCT00564824|"~     Prior work (Chris, M. et al, Clinical Science 2005; 109, 55-60) has demonstrated that~     drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent FMD~     (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy~     adults subjects.~      This effect might be attributed to caffeine, given that decaffeinated coffee (<2 mg of~     caffeine) was not associated with any change in endothelial performance.~      In the current study we intend to further examine the impact of caffeine on brachial~     endothelial function among healthy subjects & in patients with proven ischemic heart disease.~   "
228602|NCT00564811|"~     The aim of the study was to verify the influence of Agaricus blazei (Murrill) ss. Heinemann~     (A. blazei) on the evolution of nutritional state and liver function in hepatitis C patients.~   "
228603|NCT00564798|"~     Shapedown BC is being implemented at a single centre (BC's Children's Hospital). We will use~     the data routinely collected by the Shapedown program and evaluate the effect of the program~     and whether any changes are sustained for up to 2 years. A group of subjects who expressed~     interest in the program but ultimately decided not to participate will be used as a reference~     group.~   "
228604|NCT00564785|"~     We hypothesized that the analgesic effect of Synera™ analgesic patch would be superior to~     traditional infiltration with lidocaine for pain of epidural needle insertion in laboring~     parturients.~   "
228605|NCT00564772|"~     This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female~     subjects of the pharmacokinetic interaction between raltegravir and Kaletra.~   "
228606|NCT00564759|"~     The aim of the study is to evaluate the side effects and risks after infusion of retroviral~     gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned~     (busulphan)patients with chronic granulomatous disease (CGD). Also gene corrected and~     functional active granulocytes in the peripheral blood and the engraftment in the bone marrow~     of the patients will be monitored an documented.~   "
228607|NCT00564746|"~     SB-681323 is a p38 MAP kinase inhibitor and is currently under development by~     GlaxoSmithKline. This will be an open label study conducted at one site. Six healthy male~     subjects will be enrolled to ensure at least four fully evaluable subjects. Each subject will~     receive a single 10mg/ 50 µCurie oral dose of [14C]SB-681323. Urine and faecal samples will~     be collected until 216 h after dosing but subjects may be discharged after 168 h if 90% of~     the dose is recovered and/or <1% of the dose is excreted in a 24 h period. Blood and plasma~     will be collected at various sample times after dosing to measure parent drug and total~     drug-related material. Samples of urine, faeces and plasma will be transferred into separate~     study to characterise and quantify metabolites in these matrices. Safety will be assessed by~     adverse event monitoring, vital signs, ECG and clinical laboratory tests.~   "
228608|NCT00564733|"~     This phase II trial studies how well fludeoxyglucose F 18 (FDG)-labeled positron emission~     tomography (PET) scan works in planning chemotherapy in treating patients with stage IIIB or~     IV non-small cell lung cancer (NSCLC). Drugs used in chemotherapy, such as paclitaxel,~     carboplatin, gemcitabine hydrochloride, and docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Diagnostic imaging procedures, such as FDG-labeled PET scan, may help in guiding chemotherapy~     and allow doctors to plan better treatment~   "
228609|NCT00564720|"~     This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus~     Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic~     cancer.~   "
228610|NCT00564707|"~     Purpose: To assess whether EMG directed biofeedback therapy or Botulinum toxin type A~     injection of the levator ani muscles has any effect on pain from the levator ani syndrome,~     and, in addition, to what extent either treatment is superior to the other in terms of~     anorectal physiologic measurements, and quality of life.~      Study Design: Randomized, prospective, unblinded double-armed study with crossover.~      Methodology: Female subjects, aged 18 and over, with painful levator ani muscle spasm for at~     least one month duration will be randomized to receive either biofeedback therapy or~     Botulinum toxin type A injection. After randomization they will all undergo visual analog~     pain scoring, anorectal manometry, colonoscopy (if clinically indicated), and self-reported~     SF-36 quality of life measurement. Each patient will also complete numerical pain scale~     scoring, an SF-36, and a satisfaction questionnaire at each treatment visit and follow-up~     visit. Patients will submit these by mail. Identification numbers will be assigned to each~     subject for use on the SF-36 and Satisfaction Questionnaires throughout the study. Subjects~     will again undergo anorectal manometry at the end of their treatment arms. In the biofeedback~     arm patients will be treated biweekly for up to eight treatments and be provided exercises to~     practice at home based on their muscle function noted during the biofeedback training~     session. Subjects will keep a treatment diary of the exercises they do at home to help ensure~     compliance with the protocol. In the Botulinum toxin injection arm patients will be treated~     with scheduled injections of the levator ani muscles every six weeks for up to three total~     injections of 100U each. These injections will be directed to the painful areas of the~     levator muscles as guided by physical exam and EMG measurements. Should any patient fail~     their initial randomized treatment assignment (failure defined as very dissatisfied or~     dissatisfied on the satisfaction questionnaire), they will then be allowed to cross over to~     the other study arm. In addition to numerical pain scale scoring, an SF-36 questionnaire and~     anorectal manometry will also be repeated at the time of crossover. We intend to include all~     randomized patients in the final data analysis (according to their originally assigned~     treatment arm), regardless of outcome or reason for dropout, thus making this an~     intent-to-treat analysis.~      Pivotal Study Definitions: The definition of adequate pain reduction, for the purposes of~     data analysis, will be a reduction in a subject's mean pain score of two on a numerical pain~     scale (0-10). Failure of either therapy will be defined as a response of very dissatisfied~     or dissatisfied on the satisfaction questionnaire at the end of either biofeedback (eight~     treatment visits) or Botulinum toxin (three injections) both before and after crossover.~      Outcomes: We will determine the following for biofeedback therapy and Botulinum toxin type A~     injection: mean pain reduction, any differences in anorectal physiologic measurements (such~     as mean resting anal sphincter pressure), any changes in self-reported quality of life, and~     overall patient satisfaction.~   "
228611|NCT00564694|"~     RATIONALE: Collecting information about the quality of life of patients with colorectal~     cancer may help doctors learn more about the disease.~      PURPOSE: This clinical trial is studying the European Organization of Research for the~     Treatment of Cancer (EORTC) quality-of-life-questionnaire in patients with colorectal cancer.~   "
228612|NCT00564681|"~     Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale~     (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and~     placebo.~   "
228613|NCT00564668|"~     This trial is conducted in Japan. The aim of this trial was to investigate the safety and~     efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced~     by current process in Japanese subjects with type 2 diabetes.~   "
228614|NCT00564655|"~     The objective of this trial is to examine if regional anesthetic blockade of the anterior~     abdominal wall via the transversus abdominis plane is a safe and feasible method of providing~     analgesia for children undergoing gastric tube insertion.~   "
228615|NCT00564642|"~     Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin~     and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated~     with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in~     developing countries compared to that in advanced countries with a similar dose schedule.~     Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis~     drugs induced hepatic injury. The oxidative stress is closely associated with decrease of~     glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was~     investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver~     injury.~   "
228616|NCT00564629|"~     To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single~     dose of IV acetaminophen (IV APAP) versus oral (PO) acetaminophen in the treatment of fever~     induced by a standard dose of endotoxin~   "
228617|NCT00564616|"~     The purpose of this study is to determine whether adding interactive video communication to~     dispatch instruction improves the quality of bystander cardiopulmonary resuscitation in~     simulated cardiac arrests.~   "
228618|NCT00564603|"~     Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination~     of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v.~     basal infusion of tramadol is a certified technique in postoperative pain management. We~     purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine~     is an effective way in treating postoperative pain.~   "
228619|NCT00564590|"~     We hypothesize that melatonin as compared to PPI and to placebo, improves GERD symptoms by~     decreasing esophageal acid exposure and esophageal acid sensitivity in GERD. We hypothesize~     that melatonin as compared to PPI and to placebo reduce the frequency and duration of~     transient lower esophageal sphincter relaxations (TLESRs). In addition we hypothesize that~     melatonin as compared to PPI and to placebo improves quality of life and quality of sleep of~     GERD patients.~   "
228701|NCT00563498|"~     The primary purpose of this project is to investigate if addition of glutamine, an amino~     acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow~     transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.~   "
228620|NCT00564577|"~     This will be a strain and dose-finding study in which LSN03-016011/A ETEC will be~     administered at a starting inoculum of 5x108 cfu to 5 subjects to establish a human disease~     model. If 80% attack rate (AR) is achieved without high output diarrhea, the same inoculum~     will be given to 10 more subjects for confirmation of AR. If 80% AR is not achieved, attack~     rate and severity of disease will be evaluated to determine if the dose should be increased.~     The same sequence may be conducted with WS6788A if applicable. If the LSN strain causes high~     output diarrhea the dose will be adjusted down and further dose characterization continued.~     An iterative process will be used to select the optimal strain and dose with each step~     reviewed and approved by the medical monitor.~   "
228621|NCT00564564|"~     The objective of this trial is to compare in an open trial format the efficacy of association~     of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete~     remission of obsessive compulsive disorder symptoms.~   "
228622|NCT00564551|"~     The purpose of this study is to determine if increased intake of low-fat milk products and~     calcium as part of a calorie restricted diet helps achieve a healthier body weight and body~     composition and decrease blood glucose levels in people with insulin resistance or type 2~     diabetes.~   "
228623|NCT00564538|"~     The purpose of this study is to compare kidney function, long term patient and graft~     survival, and incidence of acute rejection in liver transplant recipients between one group~     receiving thymoglobulin induction and delayed initiation of tacrolimus and another group of~     liver transplant recipients having immediate administration of tacrolimus without any~     induction immunosuppression.~   "
228624|NCT00564525|"~     The purpose of this study is to determine where amitriptyline is effective in the treatment~     of functional abdominal pain in children.~   "
228625|NCT00564512|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in~     different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as~     rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells~     and help kill them or carry cancer-killing substances to them. Others interfere with the~     ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine~     and cyclophosphamide together with rituximab is more effective than giving fludarabine and~     cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia.~      PURPOSE: This randomized phase III trial is studying giving fludarabine together with~     cyclophosphamide and rituximab to see how well it works as first-line therapy compared with~     giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with~     B-cell chronic lymphocytic leukemia.~   "
228626|NCT00564499|"~     A Scientific Research Program to evaluate the efficacy of SYMBICORT® 320/9μg in the treatment~     of COPD in real life environment by General Practitioners~   "
228627|NCT00564486|"~     This research study will look at the pain relieving ability and safety of using repeated~     doses of intravenous (into the vein [IV]) acetaminophen in the treatment of moderate~     postoperative pain after planned or elective abdominal laparoscopic surgery, such as a~     laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall~     bladder).~   "
228628|NCT00564473|"~     Herbs are physiologically active substances which can significantly affect the outcome of~     medical treatment, either by inhibiting or promoting drug disposition or through additive and~     synergistic effects when used in conjunction with conventional medications. Herb-drug~     interactions are potentially dangerous, and may be difficult to predict since regulation of~     the preparations is often lacking, and patients most often do not report the use of these~     products to their physicians. The risk for toxic effects and adverse interactions increases~     among high-risk groups, such as the elderly or patients with renal or hepatic disease. The~     purpose of this study is to study the prevalence of use of herbal medicine among patients~     hospitalized in the internal medicine department of an Israeli hospital, as well as examine~     the effect of herbal remedies on patient health, either beneficial or harmful. For this~     purpose, a questionnaire evaluating demographic data, medical history (both current and~     past), use of and attitudes towards herbal medicine will be administered to patients in the~     Department of Internal Medicine at the Shaare Zedek Medical Center in Israel. The Beck~     Depression Questionnaire will be used as well.~   "
228629|NCT00564460|"~     Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic~     hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that~     preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP.~     However, no study has examined the effect of preoperative Finasteride on clinical outcomes.~      The study is a randomized, double-blind, placebo-controlled trial of preoperative Finasteride~     versus placebo in BPH patients undergoing TURP. Participants will be stratified by prostate~     volume (30 to 65 grams versus 66 to 100 grams) and randomly assigned to preoperative~     Finasteride or placebo. The primary end point is incidence of RBCT. Secondary end points are~     standard units of red blood cells transfused, variables related to perioperative bleeding~     (incidence of readmission, incidence of return to hospital, length of hospital stay), blood~     loss, change in serum hemoglobin, change in serum hematocrit, blood loss per gram of resected~     prostate tissue, operating time, change in AUA-SS, and change in HRQOL.~   "
228630|NCT00564447|"~     The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to~     Vigamox at various time points in conjunctiva tissue of healthy volunteers~   "
228631|NCT00564434|"~     Risk factors for postoperative delirium in hip fracture patients.~   "
228632|NCT00564421|"~     The purpose of this study is to determine the safety and efficacy of epinastine nasal spray~     compared to placebo for the treatment of subjects with seasonal allergic rhinitis~   "
228633|NCT00564408|"~     The purpose of this study is to test if carbachol infusion induces headache in migraine~     subjects as well as intra- and extra-cerebral vasodilatation.~   "
228634|NCT00564395|"~     We study blood sugars in the children with T1DM, who are given insulin detemir and a rapid~     acting insulin. We hypothesize that there is no difference in the patterns of blood sugars~     when detemir is given in the same syringe or in separate syringes with rapid acting insulin.~   "
228702|NCT00563485|"~     The purpose of the study is to compare two alpha blockers, terazosin and doxazosin GITS, in~     achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in~     delaying or avoiding a TURP.~   "
228635|NCT00564382|"~     In this study, we investigate the role of Cardiac Magnetic Resonance Imaging in patients with~     suspected, but not yet proven, acute cardiac syndrome ACS. Patients are included if they~     presented to the local Emergency Department with chest pain, but the first tests in the~     Emergency Department are negative or not clearly indicative of cardiac ischemia. For example,~     the first lab value Troponin T is negative or borderline elevated; or the first ECG is not~     clearly indicative of ischemia. The standard procedure for these patients is to wait 4-6~     hours and then repeat the test; if they continue to be negative, the patients are discharged~     home, if the have become positive, an invasive coronary artery angiography has to be~     performed. We think, that a CMR study can shorten the time needed to make the decision of~     either discharge or admit to CCU and perform a coronary artery angiography. CMR has been~     shown to be the gold standard for heart function (thus, can see even subtle wall motion~     abnormalities), for tissue characterization (so-called T2-weighted images can identify tissue~     edema (swelling); perfusion images can identify areas with reduced blood supply; late~     enhancement images can safely identify fibrotic or irreversibly damaged tissue) and can even~     be used to stress the patients to exclude a critical or non-critical narrowing of coronary~     arteries.~      The primary endpoint of this study will be the impact of CMR on the time-to-decision in these~     patients.~      It should be possible to a) identify all patients WITH an acute infarct by CMR and send them~     to a cath lab sooner compared to waiting for a second test; b) identify all patients WITHOUT~     an acute infarct and c) perform a stress test in those patients to exclude severe coronary~     artery disease.~   "
228636|NCT00564369|"~     Advocacy groups have voiced concerns about the ethics of some of tenets of the CDC's new HIV~     testing recommendations for the healthcare setting. Three concerns are paramount: (1) the~     opt-out approach to HIV testing can potentially be coercive and not truly voluntary; (2) by~     replacing informed consent with general consent for medical care, test participants might not~     know or be adequately informed of the benefits and consequences of testing; and (3)~     eliminating HIV prevention counseling from the HIV testing process presumes that test~     participants are aware of how to prevent an HIV infection, which might not be correct. This~     study involves conducting interviews of HIV advocates who are raising these concerns,~     surveying outpatient and emergency department clinical providers about their beliefs and~     opinions regarding the tenets of the new guidelines, and then conducting a multi-center,~     randomized, controlled trial in which the ethical concerns of opt-out vs. opt-in testing are~     directly compared. We will conduct a multi-center, randomized, controlled, trial whereby~     patients will be surveyed on their perspectives and perceptions regarding opt-out or opt-in~     rapid HIV testing. We will survey the participants regarding their perception of coercion,~     their understanding of the elements contained in the informed consent process, their HIV risk~     factors, and their knowledge of HIV prevention. We will evaluate whether or not the~     CDC-recommended approaches regarding opt-out testing, consent, and decoupling of prevention~     counseling are supported. If there are no differences regarding these ethical concerns~     between testing approaches, then the opt-out approach would be considered not to be inferior~     to the opt-in approach.~   "
228637|NCT00564356|"~     To assess the risks of intra- and postoperative bleeding tendency associated with cataract~     surgery by phacoemulsification in patients on coumadin and antiaggregant treatments.~      Design: Consecutive prospective study.~   "
228638|NCT00564343|"~     The proposed project is a case control study design. Subject's suffer from stroke willing to~     participate in the study will be shortly interviewed to assess eligibility according to the~     inclusion-exclusion criteria. Subjects suffer from chronic hemiplegia that upon questioning~     was judged to meet the following inclusion criteria: (a) able to stand independently 90~     seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal~     instructions. The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to~     ambulate independently (cane acceptable, walker not). (c) Severely impaired cognitive status~     (score less then 24 in Mini Mental State Examination). (d) Persons with impaired~     communication capabilities.~      The whole project will be conducted over a period of 3 months. A total of 36 subjects will be~     assigned to water based exercise program. The exercise group will meet on 24 occasions over a~     period of 12 weeks (2 times/week). The subjects of the exercise group will be recruited from~     Sha'ar Ha'negev Swimming pool and from patients that get a Physical Therapy treatment Kupat~     Holim Clalit.~      Gait and balance function will be tested in both groups with well established measuring~     techniques before and after the training period. The measuring techniques 1) Medical~     background variables. 2) Berg Balance Scale. 3) Late life Function and Disability Instrument.~     4) Get up and go test - stand up and walk 3 meters turn around and walk back to the chair. 5)~     step execution test under single and dual task; 5) stability tests. 6) also fall will be~     monitored a year after the completion of the study. The water training intervention is~     performed on different levels where each level reflects different increasing demands on the~     postural control system. For example, the instructor can increase the difficulty of a certain~     water-exercise by instructing a participant to use less external support, close the eyes,~     decrease the support area (stand on one leg or narrow the stance, or on unstable surface).~     These tools allow the instructor to implement step exercises on a group level that are~     still challenging for each individual even if the skill level in the group varies. The water~     exercises also include perturbation exercises that trigger specific reflex-like balance~     responses. On each level the instructor can instantly modify an exercise to be more or less~     challenging for each participant.~   "
228639|NCT00564330|"~     Dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux~     will be assessed clinically and using a novel optical coherence tomography (OCT) laser~     technique before and after double-blind randomization to antisecretory treatment with~     esomeprazole 20mg or placebo bid for 3 weeks.~      The primary objective is to quantify tooth substance loss as well as changes in optical~     reflectance and scattering of dental hard tissues with and without acid inhibition.~      Secondary objectives are:~      To compare standardised visual scoring with OCT quantification of reflux damage at the~     different time points on different teeth.~      To assess sex differences in OCT- quantified dental tissue loss.~   "
228640|NCT00564317|"~     The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation~     protocol in treating traumatized children when applied by locally trained teacher counsellors~     as well as the effectiveness and adequacy of such a treatment in a south-asian war affected~     stayee child community.~   "
228696|NCT00563576|"~     Many women choose Depo-Provera for birth control because it is easy to use and very~     effective. However, a significant number of Depo-Provera users experience irregular bleeding~     during the first 90 days. Many users discontinue after their first injection due to irregular~     bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the~     first 90 days of Depo-Provera use to see if it is acceptable to women and whether it~     decreases irregular bleeding during the first 90 days of use and increases continuation to a~     second injection.~   "
228697|NCT00563563|"~     The purpose of this study is to determine whether a combination of naltrexone SR and~     bupropion SR is safe and effective in the treatment of nicotine-dependence in overweight and~     obese subjects.~   "
228641|NCT00564304|"~     Nasal Potential Difference measurements (NPD) have been performed in Israel since 1996. NPD~     measurements are used to assess the voltage across nasal epithelium, which correlates with~     the transport of sodium and chloride across cell membranes. NPD was first demonstrated to be~     abnormal in Cystic Fibrosis (CF) in 1981 and the technique has since been used to increase~     our understanding of this condition. It is now established as an important diagnostic tool~     and more recently has been used to assess the effectiveness of new treatments such as gene~     and alternative therapy (Knowles 1995; Wilschanski 2003).~      The nasal cavity is accessible which makes it a good site to examine the ion transport~     characteristics of airway epithelia. Less than a centimetre into the nose the squamous (skin~     type) epithelium becomes ciliated pseudocolumnar epithelium, characteristic of the proximal~     airways.~      The change in NPD with the perfusion of different solutions is demonstrated. By employing NPD~     protocols with perfusion of different solutions and drugs, different aspects of the nasal ion~     transport characteristics can be examined. In CF, this ion transport profile is abnormal and~     the NPD measurement has a number of features that differentiate CF from non-CF. This~     methodology is well established for measurements in subjects over 6 years of age.~      Measurements on smaller children and infants have been very difficult to perform. We propose~     a new method using smaller, single lumen catheters with much lower perfusion rates (0.2~     ml/min compared to up to 5 ml/min with the adult method) .Perfusion measurements will be~     possible in newly born infants. Obviously this opens up the potential for using NPD as a~     diagnostic test in babies. This is important as the diagnosis of CF is often difficult to~     make or refute in babies because of the problems in collecting enough sweat. This may be the~     ideal diagnostic test for CF in the neonatal nursery in infants with meconium plug syndrome.~   "
228642|NCT00564291|"~     Comparison of different OCT instruments to assess retinal thickness, correlation to~     fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy~   "
228643|NCT00564278|"~     This study will evaluate the effectiveness of adding motivational interviewing to~     antidepressant treatment for major depressive disorder in Hispanic adults.~   "
228644|NCT00564265|"~     This is a retrospective analysis and description of the preferred diagnostic and treatment~     methods employed on GIST on the Region of Coquimbo from 2003 to 2008.~   "
228645|NCT00564252|"~     the purpose of this study is to evaluate the efficacy of topical Finasteride in the treatment~     of idiopathic hirsutism~   "
228646|NCT00564239|"~     The purpose of this study is to determine whether cognitive-behavioral group prevention~     (CBT-G) for german children is effective and to what extent parental group training moderates~     outcome.~   "
228647|NCT00564226|"~     The primary objective of this study is to evaluate the efficacy of SSR240600C in women with~     overactive bladder compared to placebo using tolterodine as a study calibrator.~   "
228648|NCT00564213|"~     To evaluate and compare the effect of the prophylactic use of two different exposure times of~     mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for~     high myopia (> -7.0 D).~      Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were~     included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years.~     Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each~     patient, one eye was randomly assigned to PRK and a single intraoperative topical application~     of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group~     2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal~     thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected~     visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of~     corneal opacity (haze) were evaluated over 12 months~   "
228649|NCT00564200|"~     The primary objective of this study is to analyze the efficacy of allogeneic bone marrow~     transplantation in a reduced-intensity manner combined with bortezomib in the treatment of~     multiple myeloma with bad prognosis, in order to evaluate the response and relapse rates~   "
228650|NCT00564187|"~     Primary:~        -  To evaluate the efficacy of two regimens of irbesartan in patients responding but not~          normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300~          mg/day for 6 more weeks)~      Secondary:~        -  To evaluate the percentage of patients with DBP < 90 mmHg at 6 and 12 weeks~        -  To evaluate the percentage of patients with SBP < 140 mmHg at 6 and 12 weeks~        -  To evaluate rate of adverse events during the study~   "
228651|NCT00564174|"~     To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies~     randomized to either low molecular weight heparin plus aspirin versus aspirin alone.~   "
228652|NCT00564161|"~     We hypothesize that misexpression of vascular endothelial growth factor (VEGF) in the~     Cerebrospinal fluid of preterm infants can be used as a biomarker to predict the risk for~     developing white matter damage.~   "
228653|NCT00564148|"~     The study intends to assess the effect of Avastin injections in different proliferative~     retinopathies due to different causes~   "
228654|NCT00564135|"~     With the advent of minimally invasive surgery, laparoscopic assisted vaginal hysterectomy~     (LAVH) is currently advocated as an alternative to abdominal hysterectomy. Reported benefits~     of LAVH in short-term study, when compared with the abdominal hysterectomy, include shorter~     hospital stays and convalescence, less postoperative pain, lower morbidity. To our best~     knowledge, no study has been conducted to examine bladder catheterization is associated with~     PUR and UTI after LAVH. No study has been performed to evaluate the long-term sequelae of PUR~     after LAVH.~      In this study, 150 patients undergoing LAVH are randomly assigned to have an indwelling Foley~     catheter for 0 (n = 50), at 7AM-8AM in the morning of postoperative day 1 (n = 50), at~     7AM-8AM in the morning of postoperative day 2 (n = 50) after the procedure by selecting a~     sealed envelope, which is opened before the operation. The inclusion criteria are uterine~     fibroids, endometriosis, abnormal bleeding, uterine prolapse and intra-epithelial neoplasia~     of the cervix grade 3. Patients are excluded if they experienced pelvic reconstructive~     surgery for pelvic organ prolapse or stress urinary incontinence; if they have bacteriuria~     and clinical urinary tract symptoms, e.g. dysuria, frequency, urgency and stress incontinence~     before surgery. After surgery, all patients stay at least 2 days in the hospital. The~     incidences of febrile morbidity and other postoperative complications are recorded. The~     outcome is assessed as immediate postoperative urinary tract symptoms, urinary tract~     bacteriuria (defined as a positive culture > 105 organisms/µl), postoperative fever > 38°C~     and urinary retention or the inability to pass urine 6 hours after catheter remove. All~     patients are followed up at 3 months and one year after surgery. To demonstrate quality of~     life of women after undergo LAVH, a generic instrument of MOS Short Form 36 (SF-36) and two~     specific instruments for urinary problems, Incontinence Impact Questionnaire (IIQ7) and~     Urinary Distress Inventory (UDI) are asked to answer in all patients before surgery and~     postoperative follow-up. All data are analyzed by the two-tailed Fisher exact test when~     appropriate. Correlation coefficients are calculated to determine the associations of~     preoperative, intraoperative, and postoperative factors with the incidence of postoperative~     urinary retention and positive urine cultures. A value of p < 0.05 is considered~     statistically significant.~   "
228655|NCT00564122|"~     This study will characterize the accuracy of a commercially available~     artificially-intelligent stethoscope in determining which childhood murmurs suggest~     underlying congenital structural heart disease and therefore warrant diagnostic~     echocardiograms.~   "
228656|NCT00564109|"~     Retrospective analysis of PSP- and PAP-serum levels in trauma patients with soft tissue~     defects and possible correlation with the incidence and onset of infection and sepsis.~   "
228657|NCT00564096|"~     Until recently stimulation of nervous tissue deeper than approximately 2 cm from the scalp~     (will hence be called non-deep TMS) was not possible (3).A new coil (H-coil invented in~     Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel ) capable of~     stimulating more than twice this depth (Up to 5 cm)was recently developed.Deep TMS is using~     this h-coil.~      Auditory hallucinations are reported by 50% to 70% of patients with schizophrenia and~     generally consist of spoken speech or voices. . Patients usually describe the hallucinatory~     experience as distressing, consistent with evidence that the most common hallucinated~     utterances are abusive terms,contributing in up to 25% of the cases to a serious suicide~     attempt.The neuroanatomical basis of auditory hallucinations is thought to involve increasing~     blood flow of the speech perception areas of the brain, such as the superior temporal cortex~     of the dominant hemisphere as well as right and left superior temporal cortex.Brain imaging~     studies of patients with auditory hallucinations have revealed an active area in the right~     and left superior temporal cortex, Broca's area, and the left temporoparietal cortex.~     Shergill et al. reported the presence of active areas in the anterior cingulate cortex, right~     thalamus, left hippocampus, and parahippocampal cortex when subjects were experiencing~     auditory hallucinations.~      Magnetic Stimulation of Left Temporoparietal Cortex suggest that the mechanism of auditory~     hallucinations involves activation of the left temporoparietal cortex.Reasons to believe that~     right frontotemporal TMS stimulation cortex can ameliorate auditory hallucinations include~     evidence that right temporoparietal stimulation achieved significant changes in the frequency~     of auditory hallucinations,in the patients with auditory hallucinations an increase in blood~     flow is noted in the right superior temporal gyrus,right temporal lobe activation during~     auditory hallucination,effect of rTMS can spread to the opposite hemisphere through~     interhemispheric connections,some evidence that brain circuits involved in the production of~     auditory hallucinations and symptoms of schizophrenia are widespread and not confined in the~     left temporoparietal cortex.Deep TMS can reach brain structures as deep as 5 cm whereas~     non-deep TMS can reach structures less than half that distance. As deep brain structures such~     as thalamic, limbic and paralimbic regions have been shown to be activated during auditory~     hallucinations and suspected to play a role in the pathogenesis of auditory hallucinations,~     their stimulation may attenuate auditory hallucinations. Non-deep TMS can stimulate the~     cortex but not the neuronal pathways connecting it to deeper brain structures and which~     stimulation may be additive.~   "
228658|NCT00564083|"~     This research protocol is a randomized controlled trial. It is being done to compare and find~     out the relative differences between the materials, (Pelivisoft) natural organic mesh to~     poly propylene mesh (Pelvitex) manmade mesh after a surgery known as sacral colpopexy. This~     surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a~     graft) attached to a ligament along your backbone (or sacrum). These materials are both FDA~     approved and widely used. The following objectives: anatomic outcomes, graft-related~     complications between the two materials, changes in pelvic organ prolapse-related quality of~     life, subjective changes in sexual function,changes in bowel function and the prolapse~     related pain present after sacral colpopexy will be evaluated.~      The study visits are all under standard of care. Study questionnaires are unique to the study~     and will be completed at the enrollment in hospital, 2, 6,12 weeks, 6 months and one year~     visits The questionnaires are related to bowel function, bladder function, prolapse and~     sexual activity.~      Permission will be requested to contact the patient again 5 years after surgery. Contact in~     the future will in no way obligate the patient to participate.~      There may or may not be direct medical benefits to the participant. Decreased risk of erosion~     may be a possible benefit if placed in the organic natural arm of the study. The~     information learned from this study may benefit other patients in the future~   "
228659|NCT00564070|"~     This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating~     people with depression and type 2 diabetes.~   "
228660|NCT00564057|"~     Human immunodeficiency virus infection and highly active antiretroviral therapy (HAART) are~     associated with an increased risk of cardiovascular disease: a wide range of alterations in~     lipid and glucose metabolism has been increasingly recognized in HIV patients treated with~     HAART. Few data are available on the effects of antihypertensive treatment on cardiac~     morpho-functional characteristics and metabolic parameters in HIV patients. Aim of the study~     is to assess the effects of chronic therapy with angiotensin receptor blocker(candesartan)or~     calcium channel blocker (lercanidipine)on metabolic profile and cardiac remodelling in HIV~     hypertensive patients.~   "
228661|NCT00564044|"~     Aging, birth trauma and extensive pelvic surgery are the causes known to cause advanced~     pelvic organ prolaspe, fecal as well as urinary incontinence. Surgical treatment is the last~     resort to manage the above-mentioned clinical manifestations of pelvic floor disorders except~     the subject is too frail to receive operation.~      In order to improve the outcome of reconstructive pelvic surgery, reinforcement with~     synthetic mesh or biological material is the modern trend in pelvic repair. Unfortunately no~     prosthesis including synthetic or biological is ideal because vaginal erosion with mesh~     extrusion which is the subject of this protocol and other complications were reported~     continuously. As per the literature, the rate for mesh vaginal extrusion ranged between 2.4~     and 17% when polypropylene which is the most popular synthetic material used for the~     mid-urethral sling or pelvic reconstructive surgery to date. The causes of this complication~     are still controversial which include rejection, poor quality of tissue, surgical artifact,~     material of mesh and etc.~      A prospective controlled study for the investigation of the cause for mesh vaginal erosion~     was conducted and the results revealed evidences of immune reactivity after mesh~     implantation, albeit the evidence was not solid (Am J Obstet Gynecol 2004; 191(6): 1868-1874~     ). As per the pilot study initially done by us to determine the biofilm-related-infection, we~     have found bacterial biofilm could adhere to surfaces and interfaces, i.e. bacteria located~     in the cells just beneath the contacting surfaces in the electron microscopic (EM) analysis.~     In addition, soon after bacteria infection, proteins in biofilm undergo conformational~     changes, making them immunogenic and triggers a typical inflammatory response leading to~     activation of the complement system. Thus, we plan to use CD (clusters of differentiation)~     antigens - 4, 8, 20, 25, 40, 68 and quantitative analysis of FoxP3 to determine the function~     of regulatory T cells in the immune response. In addition, bacterial culture and EM analysis~     of the excised mesh with surrounding vagina tissue will be performed for further analysis of~     biofilms.~   "
228662|NCT00564031|"~     Endothelial dysfunction in resistance arteries in women after the menopause is important for~     the development of high blood pressure and cardiovascular disease~   "
228663|NCT00564018|"~     To determine whether using a long-acting insulin analog at the time of diagnosis, instead of~     intermediate-acting insulin, affects the rate of loss of the body's ability to make insulin~     in children with newly diagnosed type 1 diabetes.~   "
228664|NCT00564005|"~     Identify the possible mechanisms and the relative effectiveness of existing rehabilitation~     approaches that target upper extremity deficits of stroke patients on the ground that these~     approaches are based on neuroplasticity principles and sound motor control theories.~   "
228665|NCT00563992|"~     This study will evaluate the effectiveness of two different mood stabilizing medications,~     lithium and valproate, in treating people with bipolar disorder and suicidal behavior.~   "
228666|NCT00563979|"~     The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast~     sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg~     daily, contained in VitaluxPlus®.~   "
228698|NCT00563537|"~     PET imaging of activated microglia offers a tool of investigation of a range of brain~     diseases where neuroinflammation is a component.~      Amyotrophic lateral sclerosis is the most frequent motoneuronal disease in adult.~      This study was designed to explore the feasibility of molecular imaging modality by Positron~     Emission Tomography using 18F-X as an in vivo marker of activated microglia for the~     assessment of neuroinflammation in amyotrophic lateral sclerosis.~      PET may help in the diagnosis of the disease and, further, may allow assessment of the~     efficacy of antiinflammatory treatment.~   "
228667|NCT00563966|"~     It is generally understood that smoking during pregnancy has deleterious effects on the~     developing fetus, although research on smoking during pregnancy has been limited in focus,~     with most studies focused on birth weight of newborns and children's behavioral disturbances.~     However, little is known about the neurobiological underpinnings of nicotine-related~     developmental deficits and even less is known about genetic and environmental factors that~     may exacerbate the risk for such deficits in some children. In this study, we propose to~     examine the relation between antenatal exposure to nicotine and infants' stress-responses~     before and after birth (2-days, 6-months) and its moderation of by family-based stressors and~     genes related to nicotine metabolism and stress responsivity.~      We hypothesize that the risk imposed on infants by antenatal exposure to nicotine is~     moderated by genotype that influences functioning of the HPA axis, metabolism of nicotine,~     and stress-levels and parenting that influence the development of neural substrates (HPA~     axis) and infants' capacity to cope with stress. There is a growing consensus that Gene x~     Environmental (G x E) interplay likely mediated by epigenetic effects constitute one of the~     central mechanism by which complex disorders develop. Our proposal offers an exceptional~     paradigm to explore the association between genes, environment, and G x E interactions on the~     neural and behavior response of children to stressful challenges.~   "
228668|NCT00563953|"~     This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at~     risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at~     surgery.~   "
228669|NCT00563940|"~     Diabetic macular edema is a common complication of ocular diabetes mellitus and can cause~     blindness. Hypoxygenation of the retina stimulates tissue mediators, especially different~     subtypes of vascular endothelial growth factor (VEGF). VEGF is responsible for proliferation,~     extension and increased permeability of the vessels. The aim of our study was to examine the~     short-term effect of intravitreal bevacizumab (Avastin® 1.25 mg in 0.05 ml) and triamcinolone~     on visual acuity and central retinal thickness in patients with clinically significant~     diabetic macular edema (CSME).~   "
228670|NCT00563927|"~     To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.~   "
228671|NCT00563914|"~     The primary objective is to assess the safety of different doses of ferroquine with~     artesunate (AS) in adult African patients with uncomplicated malaria.~      The secondary objectives are to assess activity in reducing parasitemia and the~     pharmacokinetics of ferroquine and its metabolites.~   "
228672|NCT00563901|"~     High blood pressure is one of the most common health problems in the United States. There are~     many medications to treat high blood pressure, but there is a large variance in how people~     respond to these medications. It is believed that genetic variations may contribute to the~     inconsistent treatment response. This study will use genetic analysis to determine whether~     particular genes interact with high blood pressure medications to modify the risk of certain~     cardiovascular diseases.~   "
228673|NCT00563888|"~     Effective Treatment of PTSD involves talking about the traumatic event in detail.It is~     unclear how this process influences the sensory-specific trauma network (fear structure)in~     the traumatized person. The goal of the project is to test the hypothesis that~     treatment-facilitated recovery does not change the original fear structure but establishes an~     inhibitory mechanism that depends on verbal activity. An affective visual steady-state~     paradigm in magnetencephalography (MEG) using positive, aversive and neutral picture stimuli~     will be used to examine the spatial and temporal pattern of the processing of emotional~     stimuli. To examine the effects of treatment this paradigm will be used as outcome measure~     within a randomized controlled trial of Narrative Exposure Therapy and a waiting-list control~     condition for severely traumatized torture victims.~   "
228674|NCT00563875|"~     Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It~     has been speculated that these patients might be resistant to aspirin, and studies have~     indicated that this phenomenon is related to a less favourable prognosis. Furthermore,~     patients with diabetes mellitus have an increased risk of myocardial infarction and other~     vascular events and, recently, it has been suggested that diabetics do not respond adequately~     to aspirin. The purpose of this study is to compare the prevalence of aspirin resistance in~     diabetics and non-diabetics. Furthermore, patients who suffered a myocardial infarction while~     being treated with aspirin are included. We hypothesize that the prevalence of aspirin~     resistance will be higher among diabetics compared to other patients and to healthy~     individuals.~   "
228675|NCT00563862|"~     To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally~     advanced nasopharyngeal carcinoma.~   "
228676|NCT00563849|"~     To determine the efficacy and safety of the combination of leflunomide and methotrexate for~     treating active rheumatoid arthritis (RA) in an open noncomparative multicenter trial.~   "
228677|NCT00563836|"~     Primary evaluation of the safety, tolerability and feasibility regarding specific~     postoperative complications of an adjuvant treatment with catumaxomab administered after~     tumor resection.~   "
228678|NCT00563823|"~     RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with~     metastatic cutaneous melanoma that cannot be removed by surgery.~   "
228679|NCT00563810|"~     This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and~     pharmacodynamics of an investigational new drug.~   "
228680|NCT00563797|"~     The objective of this study is to evaluate the efficacy of mecamylamine (MEC, 10 mg/day)~     versus placebo in reducing depressive and alcohol symptoms in patients with depression and~     co-morbid alcohol dependence. The researchers hypothesize that MEC will significantly reduce~     depressive symptoms and decrease alcohol consumption compared to placebo in patients with~     depression and alcohol dependence who are on a stable dose of a selective serotonin reuptake~     inhibitor (SSRI).~   "
228681|NCT00563784|"~     The goal of this clinical research study is to find out if erlotinib given with chemotherapy~     and radiation therapy can help to control NSCLC. The safety of this combination treatment~     will also be studied.~      Researchers will also test the tissue from your earlier biopsy to measure the levels of~     epidermal growth factor receptor (EGFR). The purpose of EGFR testing is to learn about any~     link between various forms of EGFR and your response to treatment with erlotinib.~   "
228683|NCT00563758|"~     Idiopathic or functional constipation is a common disorder, affecting up to 20% of the~     population depending on demographic factors, the sampling situation and the definitions used.~     Constipation is a symptom of many diseases and is a collective term, used by the patient to~     imply that stools are too hard, too infrequent or too difficult to pass. A recent survey~     conducted in Hong Kong showed a prevalence of 14% according to the Rome criteria. Based on an~     epidemiological study in US, there were 2.5 million annual physician visits for this problem.~     Exact epidemiological data however are lacking, mainly because of the difference between~     self-reported constipation and scientifically defined constipation.~      Treatment of constipation is usually based on increased dietary fiber and supplementation~     with bulking agents, exercise, and habit training. However, often only partial relief is~     obtained, and the majority of patients use non-bulking laxatives on a regular basis without~     medical supervision. Chronic use of non-bulking laxatives is often inappropriate3, and may~     lead to side effects such as dependency and progressive tolerance, electrolyte imbalance,~     and, for the anthraquinones, melanosis coli. In addition, stimulant laxatives may damage the~     myenteric plexus4, resulting in cathartic colon5. A more appropriate approach to the therapy~     of constipation consists of physiologically stimulating intestinal motility.~      Tegaserod, an aminoguanidine indole compound, is a representative of a new class of 5-HT4~     agonists, with regard to both chemistry and pharmacology. Activation of 5-HT4 receptors~     triggers the release of neurotransmitters from the enteric nerves resulting in increased~     contractility and stimulation of the peristaltic reflex.~      In animal models, tegaserod acts as a motility-enhancing agent, exerting activity throughout~     the gastrointestinal tract11. Tegaserod has also been shown to significantly accelerate bowel~     transit in healthy volunteers and in patients with constipation-predominant irritable bowel~     syndrome (C-IBS).~      Based on the pharmacodynamic properties, tegaserod is a promotile compound suitable for the~     treatment associated with small and/or large bowel dysfunction e.g. constipation.~      From phase III adequate and well-controlled studies in patients with C-IBS it has been shown~     that tegaserod was effective in relieving symptoms of C-IBS. The effect was seen as early as~     the first week of treatment with sustained effects over 12 weeks. Both tegaserod 4 mg/d (2 mg~     bid) and 12 mg/d (6 mg bid) significantly increased bowel frequency and decreased stool~     consistency. It is proposed to test both doses for the phase III program in chronic~     constipation.~      The aim of this study is to demonstrate the effect of tegaserod on bowel habits in patients~     suffering from chronic idiopathic constipation.~   "
228684|NCT00563745|"~     In unstable patients needing oxygen and/or home mechanical ventilation, a nurse-centred TM~     programme (supported by continuous availability of a call centre and a pulsed oxygen system)~     is cost/effective saving health care resources.~   "
228685|NCT00563732|"~     Primary: To evaluate the effects of multiple doses of lecozotan SR on the PK profile of a~     single dose of digoxin in healthy adult subjects.~      Secondary: To assess the safety and tolerability of the coadministration of lecozotan SR and~     digoxin.~   "
228686|NCT00563706|"~     The primary purpose of this protocol is to establish the efficacy, safety, and tolerability~     of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of~     schizophrenia.~   "
228687|NCT00563693|"~     An investigation where patients with chronic heart failure and cheyne stokes respiration,~     treated with adapitve servo ventilator, will improve their cardiac function and quality of~     life.~   "
228688|NCT00563680|"~     Single-arm, open-label study of AMG 479 in up to 35 subjects with Ewing's Family Tumors~     (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have progressed or recurred~     after at least one prior chemotherapy regimen. An exploratory cohort of an additional up to~     10 subjects with prior exposure to anti-IGF-1R therapy and who have progressed or recurred~     after at least one prior chemotherapy regimen will also be assessed.~   "
228689|NCT00563667|"~     Pterygium is known to induce with-the-rule astigmatism. Excision of pterygium will steepen~     the cornea and reduce corneal astigmatism. We postulate that the alteration of keratometry~     reading will indirectly affect the IOL power calculation in cases with concurrent pterygium~     and cataract. Concurrent pterygium and cataract is common in Hong Kong and other tropical~     regions. The effect of pterygium excision on intraocular lens power calculation is~     investigated.~   "
228690|NCT00563654|"~     The purpose of the study is to compare alfuzosin GITS once daily versus placebo in achieving~     a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or~     avoiding a TURP.~   "
228691|NCT00563641|"~     The present study will test the use of very early nasal continuous airway pressure(NCPAP)with~     and without surfactant in premature infants with clinical evidence or respiratory distress~     syndrome. We hypothesize that premature infants exposed to very early NCPAP and surfactant~     will require less mechanical ventilation compared to those premature infants exposed to NCPAP~     alone.~   "
228692|NCT00563628|"~     Laser photocoagulation has become the treatment of choice in PDR. Laser photocoagulation has~     become the treatment of choice in TMD. The aim is to destroy a substantial portion of the~     peripheral retina in order to reduce the angiogenic stimulus (decrease the difference between~     oxygen demand and the administration). Their effectiveness is determined by the extent of~     destruction of the retina (2.4).~   "
228693|NCT00563615|"~     Functional constipation is a common problem in Hong Kong. In a recent telephone survey, the~     prevalence of constipation as defined by Rome II criteria was 14%. Apart from organic,~     metabolic, neurological and drug induced causes, constipation most often arises from 2~     disorders of colorectal motility: slow transit constipation or pelvic floor dysfunction or~     both. In the position statement from the American Gastroenterological Association , colon~     transit study was recommended to differentiate slow transit constipation from pelvic floor~     dysfunction. The management algorithm for normal transit and slow transit constipation was~     different and surgery should be considered for patients with slow transit constipation. In a~     recent paper by Bonapace , scintigraphy could be used to study both gastric, small bowel and~     large bowel transit time. The clinical diagnosis was changed in 51% of cases of constipation~     after scintigraphy and patient management such as adding a prokinetic agent, referral to~     biofeedback center, decision on surgery was affected in 64% of cases.~      Tegaserod is a recently approved prokinetic agent to be marketed in Hong Kong for the~     management of patients with constipation predominant irritable bowel syndrome (C-IBS). In a~     paper from Mayo clinic based on scintigraphic examination, tegaserod 2mg bd accelerates~     orocaecal transit in C-IBS patients. However studies in functional constipation basing on~     tegaserod 6 mg twice daily has not been published yet. Therefore, the Gastroenterology team~     and nuclear medicine teams of Princess Margaret Hospital, Gastroenterology teams of Caritas~     Medical Center and Yan Chai Hospital decide to study small and large bowel transit in~     functional constipation patients by scintigraphy. The efficacy of tegaserod in improving~     bowel transit is also examined in this randomized double blind placebo controlled study.~   "
228694|NCT00563602|"~     This is a prospective trial of random distribution, open, parallel group, in which patients~     with esophagic variceal bleeding will be randomized into two treatment groups, after~     controlling acute bleeding. All patients received standard medical therapy with b-blockers~     and endoscopic ligation (LEV) of esophageal varices.~      The control group will be assigned to receive LEV + Nadolol + MNI. The experimental group~     will be assigned to receive treatment according to the hemodynamic response.~      All patients included in the experimental group received LEV and pharmacological treatment~     nadolol alone or combined with MNI or Prazosin (PZ)~   "
228695|NCT00563589|"~     There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early~     mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a~     matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown~     to be an effective and safe immunosuppressant in the prevention and treatment of rejection~     after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will~     be investigated in this clinical trial.~   "
228703|NCT00563472|"~     This is an open study in 50 young, healthy, female volunteers. Women who want to participate~     and who are using hormonal contraception stop using their hormonal contraceptive and wait for~     their first spontaneous menstruation (i.e. after a wash-out cycle). Women who do not use~     hormonal contraception wait for their next menstruation. From the 9th day after start of the~     menstruation onwards follicle growth will be monitored by ultrasonography until ovulation~     occurs or until day 24 after start of their menses. Women who ovulate within 24 days after~     start of their menses will be eligible to participate and will be stratified in one of 4~     groups: 10 mg estetrol (E4) alone, 20 mg E4 alone, 20 mg E4 combined with 150 mcg desogestrel~     and 20 mg E4 combined with 200 mg progesterone. The subjects will be treated for 28 days.~     Treatment will start on the first day of their menses after the pre-treatment cycle.~      During the study period (28 days) the activity of the hypothalamic-pituitary-ovarian (HPO)~     axis will be investigated by measuring follicular development using ultrasonography and by~     determining serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone~     (LH), estradiol (E2) and Progesterone (P).~   "
228704|NCT00563459|"~     The purpose of this research study is to compare the long term effectiveness, safety and~     tolerability of carisbamate compared to two other frequently prescribed anti-epileptic drugs~     (AEDs) in patients with epilepsy.~   "
228705|NCT00563446|"~     Anaemia is a common consequence of chronic renal failure. Darbepoetin alfa is a unique~     erythropoietic protein that stimulates erythropoiesis by the same mechanism as endogenous~     erythropietin and conventional recombinant human erythropoietin (rHuEPO). Darbepoetin alfa~     has been shown to have a serum half-life 3-fold longer than that of rHuEPO, which allows~     dosing at extended intervals and less frequent injection.~      The objective is to evaluate the efficacy and safety of darbepoetin alfa therapy given at an~     extended once monthly dosing interval in the treatment of renal anaemia in continuous~     ambulatory peritoneal dialysis.~   "
228706|NCT00563433|"~     224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78)~     or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone~     antibiotic.~   "
228707|NCT00563420|"~     Lung cancer is the commonest malignant disease with a 5-year survival of 14%. In Hong Kong,~     it accounts for about 30% of all cancer death. The poor prognosis of lung cancer is due~     largely to the late clinical presentation of the disease. In order to improve the prognosis~     of lung cancer, an obvious approach is to develop sensitive methods for detecting lung cancer~     at much earlier stages when treatment is more likely to be curative.~      However, the best way for identifying early lung cancer is still need to be determined. We~     hypothesis that by examining specimens that contain shed bronchial epithelial cells i.e.~     sputum, lung cancer can be sampled in its earliest possible phase. And by using~     autofluorescence bronchoscopy, a system specifically designed to detect early lung~     cancer/pre-invasive lesions, to identify the source of abnormal cells, we may able to detect~     eraly lung cancer and followed by curative treatment to improve the prognosis of this~     disease.~   "
228708|NCT00563407|"~     Radiotherapy is standard treatment for breast cancer after lumpectomy. Although this~     treatment showed substantial patient benefits and decrease of local recurrence and deaths~     from breast cancer, it also results in some severe late side-effects, such as skin fibrosis~     and cardiac failure. It's possible to offer breast irradiation (RT) and minimizing toxicities~     radiation dose to skin, lung and heart. This will be achieved with highly conformal RT~     delivery using Tomotherapy. We plan to evaluate this approach in clinical study. We plan also~     to evaluate the value of genomic, cellular and functional imaging endpoints as predictive~     markers of toxicity in our breast cancer population. This program is expected to~     prospectively validate that Tomotherapy for breast RT can decrease skin, lung and heart~     toxicities and maintaining excellent cancer control after lumpectomy.~   "
228709|NCT00563394|"~     224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78)~     or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone~     antibiotic.~   "
228710|NCT00563381|"~     This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group~     trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg)~     via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week~     randomised treatment phase. Patients who withdraw prematurely from trial medication will be~     encouraged to remain in the trial and participate in follow-up telephone contacts until their~     predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of~     randomised treatment). The phone calls will be made at all scheduled visits.~      The primary objective of this study is to compare the effect of tiotropium (18 mcg)~     inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD~     exacerbations.~      The primary endpoint is time to first COPD exacerbation during the 52 week randomised~     treatment period. A COPD exacerbation will be defined as a complex of respiratory events /~     symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing,~     dyspnoea or chest tightness with at least one symptom lasting at least three days requiring~     treatment with antibiotics and/or systemic steroids and/or hospitalisation.~      The onset of an exacerbation is defined as the onset of the first new or increased reported~     symptom. The end of the exacerbation should be recorded as defined by the investigator.~      Only COPD exacerbations with onset during randomised treatment will be included in the~     analysis.~   "
228711|NCT00563368|"~     The objective of this study is to evaluate the safety and efficacy of various doses of~     VI-0521 compared to both placebo, and the single-agent components that comprise each~     combination dose. This study will provide confirmatory data to demonstrate that doses of~     VI-0521 have efficacy that is greater than placebo and each of the single-agent components~     that comprise the combination dose.~   "
228712|NCT00563355|"~     The primary aim of the study is to evaluate the effects of correction of anemia using~     erythropoietin on the progression of atherosclerosis and cardiac muscle thickening in~     patients with chronic kidney disease~   "
228713|NCT00563342|"~     The primary objective of the study is to examine the risk of catheter dysfunction during the~     dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled~     silicone catheters of end stage renal failure patients treated by hemodialysis.~      The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial~     or complete occlusion or infection associated with dialysis catheter.~      As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total~     ultrafiltration)~   "
228714|NCT00563329|"~     The aims of this study are (1) to examine the effect of smoking reduction intervention~     (reduction counseling and nicotine replacement therapy, NRT) (a) on smoking cessation and (b)~     on reducing daily cigarette consumption among smokers not willing to quit smoking but want to~     reduce smoking, and (2) to examine the effect of adherence intervention in producing a higher~     (a) adherence rate, (b) reduction rate, and (c) quit rate.~   "
228715|NCT00563316|"~     The primary objective of this study is to determine if panitumumab affects the~     pharmacokinetic (PK) profile of irinotecan.~   "
228716|NCT00563303|"~     Interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with~     relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic~     complications and organs injuries.~   "
228717|NCT00563290|"~     This phase II trial is studying how well dasatinib works in treating patients with~     unresectable or metastatic squamous cell skin cancer or RAI Stage 0-I chronic lymphocytic~     leukemia. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~   "
228718|NCT00563277|"~     Pterygium is known to induce with-the-rule astigmatism. The corneal curvature along the long~     axis of the pterygium body is flattened. The excision of pterygium will result in steepening~     of the cornea and reduction of astigmatism. Therefore, the effect of pterygium excision on~     intraocular lens (IOL) power calculation has been examined in our previous study. The study~     confirmed that pterygium can cause alteration of IOL power.~      The determination of IOL power for cataract surgery is usually calculated from IOL formula~     called SRK II formula. IOL power = A - (2.5 x AL)-(0.9 x K). Variable A denotes the~     A-constant of the intraocular lens which is dependent on the IOL material and refractive~     index. Other variables for input include axial length (AL) and keratometry (K). A larger K~     reading will result in a lower estimated IOL power and vice versa. Previous studies have~     documented simultaneous cataract and pterygium operation resulted in reasonable visual~     outcome without adjustment of IOL power.~      With the presence of a pterygium, the cornea is flattened and lead to a reduction of K value~     and over-estimation of calculated IOL power. This randomized controlled trial is designed to~     compare the refractive outcomes of sequential and simultaneous pterygium and cataract~     operation.~      Pterygium excision should be done with various adjuvant therapies to minimize recurrence. Our~     previous studies reliably demonstrated limbal conjunctival graft and mitomycin C were~     effective methods to achieve low pterygium recurrence. We use limbal conjunctival autograft~     as the adjuvant therapy in the current study because this method is safer to be performed~     either alone or in combination with phacoemulsification. We avoid using mitomycin C as the~     adjuvant therapy in order to minimize the possibility of intraocular toxicity due to seepage.~   "
228719|NCT00563264|"~     The purpose of this study is to evaluate the efficacy of an intervention (KAN-DO: Kids &~     Adults Now - Defeat Obesity) encouraging postpartum mothers and their preschool-aged children~     to work together to promote healthy eating, increase physical activity, and reduce sedentary~     behaviors. Via instruction in parenting skills and behavior change strategies, the goal is~     relative weight maintenance in children of healthy weight, and relative weight reduction in~     overweight children. The intervention will focus on a child (2-5 years of age) and his or her~     overweight or obese mother, who has just delivered a second or subsequent baby.~   "
228720|NCT00563251|"~     Bronchiolitis obliterans syndrome (BOS), an obstructive airway disease as a result of chronic~     rejection, is one of the major causes of morbidity and mortality in long-term survivors of~     allogeneic bone marrow transplantation (BMT). Although augmentation of immunosuppressive~     treatment might help but the only effective treatment for BOS is by lung transplantation.~      Macrolide antibiotics, which have been licensed to use as antibacterial agents for decades,~     have been found to have immunomodulatory properties in addition to their antibacterial~     activity. Low dose Azithromycin, an antibiotic of the macrolide family, has been shown to~     have promising result in a pilot study in treating BOS associated with lung transplantation.~     We propose to perform a prospective, randomised, double blind study to test the efficacy of~     Azithromycin in treating BOS after BMT. Patients with proven BOS after BMT will be randomised~     into two groups based on lung function parameters. One group will receive low dose~     Azithromycin while placebo will be provided for the other group. Lung function will be~     serially monitored at 3 month, 6 months and 12 months after commencement of treatment with~     drug/placebo. If Azithromycin was proven effective in treating BOS then all patient with~     proven BOS should be treated with this drug.~   "
228721|NCT00563238|"~     Silent myocardial ischemia is known to occur in the general medical intensive care unit~     population immediately following tracheal extubation. We believe these patients are at risk~     for primary cardiac events in the 4 hours immediately following extubation. Metoprolol is a~     selective beta-1 antagonist, with little to no beta-2 activity at low and moderate doses. The~     cardioprotective effects of beta blockade have been well documented in randomized controlled~     trials. In patients undergoing extubation, prophylactic use of intravenous metoprolol may~     reduce post-extubation ischemia events as well as precursors of cardiogenic pulmonary edema~     (atrial and ventricular wall tension). Our primary hypothesis is that prophylactic metoprolol~     (titrated to reduce resting heart rate by at least 10%) prior to tracheal extubation will~     reduce the rate of ischemia as judged by ST segment analysis.~   "
228722|NCT00563225|"~     A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and~     safety of insulin glargine on subjects with Type 2 Diabetes Mellitus~   "
228723|NCT00563212|"~     Idiopathic pulmonary fibrosis (IPF) is a progressive disease for which there is no effective~     treatment. Interferon-gamma is a medication that has been used for other lung diseases to~     decrease scarring and fibrosis. Studies of interferon-gamma injected under the skin did not~     show any improvement in survival in patients with IPF. We hypothesize that giving~     interferon-gamma as a nebulized mist directly into the lungs can affect the immune system in~     a way that decreases fibrosis.~   "
228738|NCT00563017|"~     The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on~     long-acting Risperidone microshpheres injection. The major advantage of long-acting injection~     over oral medication is facilitation of compliance in medication taking. Non-compliance is~     very common among schizophrenic and is a frequent cause of relapse.~   "
228739|NCT00563004|"~     DBcare is a herbal food supplement that has been used over the years in India as a~     traditionalanti-diabetic formula.DBcare was not tested controlled trials in humans, yet.We~     intend to test the ability of DBCare to improve blood sugar level control in patients with~     uncontrolled diabetes.~   "
228724|NCT00563199|"~     This study is a randomized controlled trial designed to evaluate the effectiveness of a nurse~     delivered stage-matched intervention to cardiac patients for cessation of tobacco use. Review~     of literature shows that there is a clear lack of empirical evidence on (1) using nurses to~     deliver stage-matched smoking cessation interventions, and (2) the effectiveness of such~     intervention for cardiac patients in Chinese populations. The ultimate goal of the~     intervention achieve a higher quit rate in the intervention group than in the controls. In~     addition, the change in the patient's smoking behaviour such as reduction of the number of~     cigarettes smoked, and progression to a higher stage of readiness to quit, will also be~     measured. This study is the first step to address the urgently needed data for (1) promoting~     the delivery of nurse-run stage-matched smoking cessation interventions to help patients stop~     smoking, (2) developing smoking cessation policy and programmes in the hospitals and for the~     health care system, and (3) contributing an evidence-based approach to orientate clinical~     services towards prevention, so as to reduce premature deaths and the enormous disease burden~     of our society.~   "
228725|NCT00563186|"~     The Physical plant design and the use of engineering controls significantly affects the~     acquisition and transmission of pathogenic organisms in a hospital environment.~   "
228726|NCT00563173|"~     The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future~     treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected~     individuals with a low viral load. In addition the capability of the vaccine to induce an~     immune response and the effect on viral load will be studied. In order to increase the uptake~     of the vaccine the intra muscular injection is combined with electroporation, meaning that a~     brief electric field is applied to the injection site resulting in temporary pores in the~     cell membranes that allows the vaccine to enter the cells.~   "
228727|NCT00563160|"~     To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for~     operable stages of non-small-cell lung cancer and to identify novel molecular markers~     correlated with chemosensitivity and prognosis~   "
228728|NCT00563147|"~     The purpose of this study is to test the safety and tolerability of tivozanib (AV-951) and~     Torisel™ given in combination for renal cell cancer. The study will also assess the effects~     of the combination of tivozanib (AV-951) and Torisel™ on the tumor. Tivozanib (AV-951) is a~     VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking~     blood flow to the tumor. Temsirolimus is an mTOR inhibitor which is approved for the~     treatment of advanced renal cell carcinoma.~   "
228729|NCT00563134|"~     Sepsis sometimes occurs in people who have a serious infection. It is caused by toxic~     substances (toxins) from bacteria and other germs entering your bloodstream. Most people with~     sepsis will recover with routine medical care before the illness gets more serious. However,~     in some people, sepsis does become more serious. This severe sepsis can cause damage to~     internal organs (such as your heart, lungs, kidneys, and liver) and can be life threatening.~     Special natural fats, (called 'lipoproteins') in our blood are thought to help protect us~     from the toxins produced by bacteria during sepsis. Levels of these lipoproteins are often~     low in people with sepsis and this may make it more difficult to recover from the disease.~     GR270773 is a new drug that has been developed to help the lipoproteins in protecting the~     body against toxins. GR270773 is made from purified fats and oils from the soyabean and does~     not contain cholesterol. This research study will test the safety (side effects) of GR270773~     and whether or not it is effective in preventing complications in people with severe sepsis.~   "
228730|NCT00563121|"~     To determine the degree of VEGF in Aqueous, vitreous and SRF in patients with ROP in stage V.~     Verifying that it is greater to that found in healthy newborn patients with different ocular~     pathology.~   "
228731|NCT00563108|"~     Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity~     and mortality. Steroids remains first line therapy for acute GVHD but there is currently no~     consensus on second line therapy for those in whom steroids have been ineffective.~     Basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and~     treatment of rejection after renal transplantation and its role in acute GVHD prophylaxis and~     treatment has been described favourably. This is a randomized control trial to investigate~     its efficacy and safety in the management of acute GVHD post allogeneic stem cell~     transplantation (SCT).~   "
228732|NCT00563095|"~     Primary: To compare the efficacy of TACE and TAIE.~      Secondary: To compare the side effects of TACE and TAIE.~      The outcome measurements include survival benefit and tumour regression induced by the two~     therapies.~   "
228733|NCT00563082|"~     Systemic lupus erythematosus (SLE) is an autoimmune disease that predominantly affects~     younger premenopausal women. The risk of coronary heat disease (CHD) in women with SLE is up~     to 50 times higher than in the general population. The conventional risk factors are~     insufficient to explain this increased risk of CHD in SLE-affected women. This study will~     perform genetic analysis to determine if genetic variation in the F2 gene is associated with~     both SLE risk and CHD risk in women with SLE.~   "
228734|NCT00563069|"~     To investigate the efficacy of oral midazolam for patients undergoing rigid cystoscopy in:~        1. relieving patient's anxiety and improving satisfaction~        2. reducing procedure-related pain~        3. facilitating the diagnostic and therapeutic interventions during rigid cystoscopy~   "
228735|NCT00563056|"~     Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil®~     (Formoterol) in adolescent and adult patients.~   "
228736|NCT00563043|"~     Laser photocoagulation has become the treatment of choice in PDR. Laser photocoagulation has~     become the treatment of choice in PDR. The aim is to destroy a substantial portion of the~     peripheral retina in order to reduce the angiogenic stimulus (decrease the difference between~     oxygen demand and the administration). Their effectiveness is determined by the extent of~     destruction of the retina (2.4).~   "
228737|NCT00563030|"~     Coronary artery bypass graft (CABG) surgery is associated with reperfusion syndrome and~     activation of inflammatory reaction (SIRS). These are more exaggerated when cardiopulmonary~     bypass (CPB) is used.~      The aim of the study is to compare signs of SIRS (heart rate, tachypnea or hypocarbia,~     leukocytosis, hyperpyrexia or hypothermia) and the granulocytes subsets in peripheral blood~     from patients who underwent CABG surgery with or without use of CPB.~      The researchers expect significant differences in SIRS criteria between both groups. If the~     differences will occur significant, the parameter may be used as candidate variable for a~     complications prediction model after CABG surgery.~   "
228740|NCT00562991|"~     Asthma is a chronic inflammatory condition in which the airways develop increased~     responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It~     is characterized by airway hyper-responsiveness, inflammation, increased mucus production,~     and airway obstruction. Since inflammation is an important feature of asthma, the use of~     non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose~     of the study is to relate costs associated with healthcare utilization and loss of work and~     school time to the primary health outcome of cumulative number of symptom-free days. This~     will enable the researchers to determine whether the costs of monitoring exhaled NO to~     regular management strategy in recently diagnosed asthma will be offset by reductions in~     other costs of asthma-related care, and, if not, whether the additional costs are likely to~     be acceptable in terms of the improvement in health outcomes as measured by the additional~     number of symptom-free days.~   "
228741|NCT00562978|"~     RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can~     find cancer cells and carry tumor-killing substances to them without harming normal cells.~     Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to~     kill cancer cells or stop them from growing. Giving radiolabeled monoclonal antibodies~     together with etoposide and cyclophosphamide before a peripheral blood stem cell transplant~     may be an effective treatment for non-Hodgkin lymphoma.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90~     ibritumomab tiuxetan when given together with etoposide and cyclophosphamide followed by an~     autologous stem cell transplant and to see how well it works in treating patients with~     non-Hodgkin lymphoma.~   "
228742|NCT00562965|"~     This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given~     with rituximab compared to a defined investigator's choice therapy. Subjects will be~     randomized to one of these two arms of the study.~   "
228743|NCT00562952|"~     Increased levels of NT-proBNP are known to increase the risk of cardiac events in diabetic~     patients. The other way around, patients with normal values have an excellent prognosis on~     short-term. We intend in our study to proof the hypothesis, whether it is possible to~     decrease NT-proBNP levels by intensified cardiac prevention care We aim those patients, who~     already have elevated levels, although no history of a cardiac disease. This decrease in~     NT-proBNP should be translated consequently in a decrease in cardiac events~   "
228744|NCT00562939|"~     The purpose of this study is to determine whether TLR-9 adjuvanted pneumococcal is more~     immunogenic than pneumococcal vaccination alone in HIV-infected adults.~   "
228745|NCT00562926|"~     Gamma-aminobutyric acid (GABA) is the principal inhibitory neurotransmitter in the mammalian~     central nervous system. It is involved in a wide spectrum of physiological functions, from~     sleep and sedation to convulsions. A defect in neurotransmission involving GABA in~     schizophrenia was first propsed in early 1970s, based on neuropathologcial evidence, yet~     there is a lack of molecular genetic evidence.~      Recently, we carried out a pilot study on a region of the GABA-A receptor β2 subunit gene on~     chromosome 5 and found significant association for single nucleotide polymorphisms (SNPs) in~     the gene sequence with occurrence of schizophrenia. The current proposal aims to validate~     this important finding and to conduct a thorough scanning of the complete gene sequences of~     the GABA-A receptor subunit genes in this chromosomal region, including the three major~     subunits α1, β2 and γ2. We shall collect samples from Hong Kong Chinese subjects for a~     case-control study using haplotype maps and comparing the SNP haplotype frequencies in the~     receptor genes, and hence examine whether these genes are in association with schizophrenia,~     or other schizophrenia-spectrum disorders, including Alzheimer's disease presenting with~     psychotic symptoms.~      Based on the observation that patients suffering from the catatonic subtype of schizophrenia~     respond particularly well to benzodiazepines, which bind specifically to GABA-A receptors, we~     shall also perform data analysis in terms of correlating SNP association with schizophrenia~     subtypes. Association of GABA-A receptor genes with schizophrenia would be a major step~     forward to determining whether these genes are susceptibility genes for schizophrenia,~     thereby paving the way to more effective diagnosis and treatment for this debilitating~     disease.~   "
228746|NCT00562913|"~     Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed~     daily combined with Cyclophosphamide and Doxorubicin in cancer patients~   "
228747|NCT00562900|"~     Case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy (Da~     Vinci Robot, Intuitive Surgical). These patients are matched 1:1 to 50 patients with~     conventional laparoscopic cholecystectomy, according to age, gender, ASA score, histology and~     surgical experience.~        -  Trial with surgical intervention~   "
228748|NCT00562887|"~     To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who~     have moderately to severely active Crohn's Disease.~   "
228749|NCT00562874|"~     Many of the 28 million people with immunodeficiency virus (HIV) and acquired immunodeficiency~     syndrome (AIDS) estimated to be living in sub-Saharan Africa also suffer from malnutrition.~     Reproductive age women, their infants and young children are among the most vulnerable for~     malnutrition and progression of HIV to AIDS and mortality is increased in the malnourished,~     as seen in Eastern and Southern Africa. The HIV Nutrition Project (HNP) research evaluates~     the effect of protein and micronutrients in meat on the health and nutritional well being of~     Kenyan women living with HIV in rural Kenya and the health and development of their children,~     by means of a randomized nutrition intervention. We will determine if meat in the diets of~     HIV- infected women and their children (1) protects the immune system and prevents severe~     infection, (2) prevents the loss of body mass and enhances the quality of life among drug~     naïve women not yet ill enough to warrant antiretroviral drugs and (3) positively impacts~     growth and development of vulnerable children of the HIV-infected women when compared to~     those given supplements with the same amount of energy but with either soya or wheat protein.~     The intervention food with beef protein provides significant vitamin B12, lysine and~     bio-available iron, zinc and selenium when compared to the soya and wheat supplements.~     Deficiencies of these nutrients may hasten HIV disease progression.~      The findings from our project may have implications for the development of initiatives that~     are either sustainable or subsidized by the local, regional and/or global economies that~     ensure that all HIV-infected individuals have access to adequate nutrition support that~     includes foods that provide enough nutrients that are needed to optimize health and~     well-being. The knowledge gained may significantly impact other populations at high risk for~     decreased immune function such as those with tuberculosis and malaria.~      This is a 3 arm randomized design where 225 HIV-infected rural Kenyan mothers with a CD4~     between 250 and 500, WHO Stage 1 or 2, and with no co-existing infections, receive with their~     child, a nutrition biscuit supplement daily (5 days/week) for 12 months. These women are not~     yet ill enough to warrant treatment with antiretroviral drugs in Kenya and therefore a food~     intervention may keep them healthy longer and delay the need for drugs.~   "
228812|NCT00562055|"~     This study will compare the safety and efficacy of [S,S]-reboxetine to atomoxetine in the~     treatment of adult patients with attention deficity-hyperactivity disorder.~   "
228750|NCT00562861|"~     Bipolar depression is one of the least studied depressive illnesses. The standard practice~     for many doctors is to use antidepressant medicines, but there are few studies on the~     long-term results of these medicines. The goal of this study is to look at how effective and~     safe these medicines are in treating bipolar depression when taken with a mood stabilizer~     medicine.~      The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the~     treatment of major depression, but is not FDA approved for the treatment of bipolar~     depression. It is, however, standard practice for many doctors is to use antidepressants,~     like Celexa, to treat their patients with bipolar disorder depression.~      The drug will be studied in three ways. We will see if it helps treat depressive symptoms. We~     will see how the drug affects the brain using PET and fMRI scans. Finally, we will look at~     the possibility that there may be a gene that could predict if a person would get better~     taking the drug using genetics.~   "
228751|NCT00562848|"~     Motilin is a peptide whose action is controlled by motilin receptors located in the gut.~     Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying~     of food and fluid from the stomach). Compounds which stimulate motilin receptors therefore~     provide a potential approach to the treatment of a range of clinical conditions where delayed~     gastric emptying may contribute to symptoms, such as enteral feeding intolerance~     (post-operative or intensive care patients), gastroparesis, diabetic gastroparesis, and~     functional dyspepsia.~      This study is the First Time In Human study for the motilin receptor agonist, GSK962040.~   "
228752|NCT00562835|"~     Scientific background. Dysregulated systemic inflammation is a key pathogenetic mechanism for~     morbidity and mortality in ALI/ARDS, and is associated with tissue insensitivity and/or~     resistance to inappropriately elevated endogenous glucocorticoids. In one study, prolonged~     methylprednisolone treatment of ARDS patients resulted in rapid and sustained reduction in~     circulating and pulmonary levels of pro-inflammatory cytokines, chemokines, and procollagen.~      Preliminary work. Five randomized trials (N = 518) investigating prolonged glucocorticoid~     treatment in acute lung injury/ARDS reported a significant physiological improvement and a~     sizable reduction in duration of mechanical ventilation and ICU length of stay. Insufficient~     data is available on the effects of low dose prolonged methylprednisolone treatment initiated~     in early ALI/ARDS on mortality.~      Hypothesis. We hypothesized that the anti-inflammatory activity associated with prolonged~     methylprednisolone administration improves pulmonary and extra-pulmonary organ dysfunction in~     early ALI/ARDS and reduces mortality.~      Objective. To investigate the effects of prolonged low-dose methylprednisolone infusion on~     mortality and morbidity in early ALI/ARDS.~      Study design. Multicenter, prospective randomized, placebo-controlled, double-blind clinical~     trial.~      Entry criteria. Patients with ALI/ARDS of less than 72 hours duration.~      Stratification. Patients are prospectively stratified prior to randomization as (1) intubated~     versus NPPV treated, and (2) ARDS versus severe ARDS. The purpose of stratification is to~     distribute equally in both arms intubated versus NPPV treated, and ARDS versus severe ARDS.~      End-points. The primary end-point of trial is 28 days all cause mortality; the secondary~     end-points are (a) ventilator-free days at 28 days following study entry, (b) organ~     failure-free days at 28 days following study entry, and (c) duration of ICU stay.~   "
228753|NCT00562822|"~     The purpose of this study is to discover whether arthroscopic surgery is helpful in~     controlling the symptoms of osteoarthritis of the knee.~   "
228754|NCT00562809|"~     The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and~     300/25 mg in patients with hypertension not controlled by monotherapy.~   "
228755|NCT00562796|"~     Obesity is one of the leading causes of cardiovascular-related diseases, including diabetes~     and heart disease. Obesity, and more specifically abdominal obesity, may cause decreased~     growth hormone (GH) levels. It is believed that GH deficiency may contribute to increased~     cardiovascular risk by affecting insulin resistance, inflammatory markers, and blood~     cholesterol levels. This study will determine the occurrence of GH deficiency in abdominal~     obesity and whether GH deficiency is associated with increased cardiovascular risk beyond~     traditional risk factors.~   "
228756|NCT00562783|"~     Cirrhosis is a diffuse lesion characterized by architectural distortion of the liver because~     of collagen deposition and development of nodules of regenerating hepatocytes. It is an~     irreversible change that results from diseases characterized by chronic liver injury~     (Fujimoto, 2000). Cirrhosis alters the pattern of blood flow through the liver and results in~     impaired perfusion of hepatic lobules with intrahepatic and extrahepatic shunting of blood.~     This deprives hepatocytes of uniform perfusion by arterial and portal venous blood resulting~     in both portal hypertension and other consequences of cirrhosis including impaired protein~     synthesis and altered drug metabolism. The histologic diagnosis of cirrhosis requires the~     presence of regenerative nodules or pseudolobules completely encircled by fibrosis such as~     congenital hepatic fibrosis can result in portal hypertension in the absence of cirrhosis~     (Anthony et al., 1977).~      The events leading to the development of cirrhosis are generally those of chronic injury with~     hepatocyte destruction. Acute severe liver injury as in fulminant viral hepatitis does not~     result in cirrhosis and the liver generally returns to normal after recovery. Cirrhosis can~     be classified by macroscopic appearance, by cause, and by histologic appearance and location~     of liver damage. Micronodular cirrhosis is composed of uniform nodules less than 3 mm in~     diameter, whereas macronodular cirrhosis has varying size nodules greater than 3 mm diameter.~     Mixed nodular cirrhosis has nodules of both sizes. Some liver diseases such as alcoholic~     liver disease may present as micronodular cirrhosis and develop larger nodules with~     subsequent regeneration of hepatocytes. For this reason, many prefer etiologic classification~     (e.g., alcoholic cirrhosis). The designation of cirrhosis as post necrotic, biliary and~     portal are still commonly used and imply predominant histologic location of fibrosis.~      Cirrhosis is an irreversible disease, and attempts should be made to stabilize the patient~     and to control the cause. Factors that indicate a poor outcome include an elevated~     prothrombin time that does not correct itself with parenteral vitamin K, upper~     gastrointestinal bleeding caused by varices, ascites refractory to therapy, increased age of~     the patient, sever malnutrition, spontaneous bacterial peritonitis, a pronounced increase of~     serum bilirubin in the absence of haemolysis, and heptocellular carcinoma (Yeh et al., 2003).~     In general, all causes of upper GI bleeding are associated with an increased mortality in~     patients with cirrhosis. For those with alcoholic cirrhosis who lack portal hypertension,~     survival is similar to an age-matched cohort if alcohol intake is stopped (Nakamura et al.,~     1991). If ethanol consumption continues, mortality is higher. Cirrhosis can be present~     without clinically significant complications and be identified only at autopsy or during~     evaluation of abnormal liver tests (Mendez et al., 2003). However, for many patients the~     disease is slowly progressive resulting in one or more complications. The clinical~     manifestations of cirrhosis are a result of altered hepatic blood flow through the liver with~     intrahepatic shunting causing impaired perfusion of hepatocytes or portal hypertension with~     shunting of blood around the liver though portosystemic communications. The major~     complications of portal hypertension include oesophageal or gastric varices, ascites,~     portosystemic encephalopathy, and hepatorenal-syndrome (Menon & Kamath, 2000). With~     impairment of hepatocyte perfusion or reduction of hepatocyte number, altered synthetic~     function can result in hypoalbuminemia, hypoprothrombinemia, and changes in drug metabolism.~      Vitalliver is a Chinese medicine which is administered in the form of a suppository, which is~     uncommon for most Chinese medicines. Medications released from the suppositories are absorbed~     directly from the circulation around the rectum and then reach the liver via the portal vein.~      Basic pharmacological studies have shown that Vitalliver has good immunomodulating functions,~     increases the activities of T-cells, B-cells and NK cells, therefore this formulation may~     have special values in treating liver diseases.~   "
228757|NCT00562770|"~     To determine if the rate of cytomegalovirus reactivation during treatment with alemtuzumab~     (Campath) is reduced by the use of valganciclovir prophylaxis.~   "
228758|NCT00562757|"~     The purpose of this study is to determine how well the device predicts susceptability to~     potentially lethal ventricular arrhythmias.~   "
228759|NCT00562744|"~     Patient simulation is a new and expanding technology that has proven effective as a teaching~     tool in various clinical settings, but data on pediatric simulation is lacking. Mock~     resuscitation scenarios have been shown in prior studies to be effective for improving~     knowledge, skill, and confidence in pediatric housestaff. Our objective is to assess the~     utility of a training program utilizing a human patient simulator of an infant as a teaching~     tool for pediatric housestaff training in resuscitation skills. We hypothesize that mock~     resuscitation exercises performed by pediatric housestaff on a patient simulator will result~     in improved performance on test scenarios when compared to the same training on a standard~     manikin.~   "
228760|NCT00562731|"~     Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in~     clinical practice and has significant effects on patient well-being. The purpose of this~     study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement~     therapy in testosterone deficient men.~   "
228761|NCT00562718|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make~     tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine~     after surgery may kill any remaining tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving capecitabine~     together with radiation therapy works in treating patients with nonmetastatic breast cancer.~   "
228762|NCT00562705|"~     This is a two arm, randomized, prospective, intervention study in order to determine the~     effects of growth hormone treatment on eating regulation and to compare between the growth~     responses with or without nutritional intervention in short stature children.~      The study will include 30 short stature children that are about to initiate growth hormone~     treatment and will last for one year. After 4 months of treatment, children will be~     randomized into two groups:~        1. Control group that will continue with growth hormone treatment without any other~          intervention.~        2. Study group that will be a given a nutritional intervention in addition to growth~          hormone treatment.~      At screening visit and during the study the following parameters will be evaluated: height,~     weight, growth markers in the blood and urine, child eating behavior questionnaire, blood~     tests, hormonal tests and resting energy expenditure measurements.~   "
229186|NCT00556998|"~     This study is designed to collect additional pharmacokinetic and safety data of voriconazole~     in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help~     establish voriconazole dosing recommendations for adolescents.~   "
228763|NCT00562692|"~     Brain natriuretic peptide (BNP) is a useful therapy when treating patients with heart~     failure. As many of these patients also have airways disease it is important to determine if~     BNP also has a positive effect on their respiratory condition. The role of BNP in airways~     disease has never been studied although there is evidence to suggest that it will have a~     positive effect.~      The current study is therefore a proof on concept study which will demonstrate whether BNP~     (nesiritide) will improve both heart failure and airflow obstruction in patient who have~     both.~      The investigators are looking to enroll 40 patients with heart failure and airways disease~     who present to hospital emergency departments. Patients who consent and meet the entry~     criteria will be randomised to receive either nesiritide or placebo in addition to standard~     therapy. They will receive a bolus of study medication followed by a 4 hour infusion. Before,~     at hourly intervals and immediately following the infusion the following data will be~     collected:~        -  dyspnoea score~        -  respiratory rate~        -  FEV1 (if able to be performed)~        -  peak respiratory flow rates (PEFR, if able to be performed)~        -  requirement for concomitant bronchodilator therapy~        -  urinary GMP At all times during the study period and at the conclusion of the study~          patients will be provided with the best available therapy for their condition at the~          physicians' discretion.~   "
228764|NCT00562679|"~     The purpose of this study is to determine the effect of sleep apnea on mortality, stroke and~     myocardial infarction among 408 patients with coronary artery disease referred for evaluation~     of coronary intervention who were examined with overnight cardio respiratory monitoring~     between March 1992 and June 1995.~   "
228765|NCT00562666|"~     For most patients with hepatocellular carcinoma, surgery or other curative procedures are not~     possible and only palliative measures could be applied (chemoembolization, targeted drugs,~     best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product~     will be evaluated in patients in a palliative setting. All patients will have one hepatic~     intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be~     evaluated for safety.~   "
228766|NCT00562653|"~     The purpose is to evaluate autoantibodies in infective endocarditis patients before, at the~     beginning of treatment, and after the end of the treatment, and to correlate the~     autoantibodies in the presence of clinical symptoms.~   "
228767|NCT00562640|"~     RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the~     bone marrow to the blood so they can be collected. Treating stem cells collected from the~     patient's blood in the laboratory may increase the number of immune cells that can mount an~     immune response against the tumor. The treated stem cells may help destroy any remaining~     tumor cells (graft-versus-tumor effect). Chemotherapy may also be given to the patient to~     prepare the bone marrow for the stem cell transplant.~      PURPOSE: This phase I trial is studying the side effects and best dose of autologous T cells~     when given with or without cyclophosphamide and fludarabine in treating patients with~     recurrent or persistent advanced ovarian epithelial cancer, primary peritoneal cavity cancer,~     or fallopian tube cancer. (fludarabine treatment closed as of 12/012009)~   "
228768|NCT00562627|"~     Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain,~     causing patient discomfort, mobilisation and hospital discharge.~      The aim of this study is to:~        1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee~          arthroplasty.~        2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural~          analgesia.~   "
228769|NCT00562614|"~     The purpose is to determine the effect of SLx-2101 dosed at 5mg or 10mg for 14 days on~     systolic, diastolic pressures and heart rate in patients with hypertension.~   "
228770|NCT00562601|"~     This study will collect blood plasma and white blood cells from individuals using a procedure~     called apheresis. Apheresis is a method of collecting larger quantities of certain blood~     components than can safely be collected through a simple blood draw or blood donation~     process. The blood components will be used in laboratory research studies to investigate~     aspects of infectious and immunologic allergic diseases.~      Patients 7 years of age and older who are currently enrolled in a NIH clinical research~     protocol may participate in this study. (Children between the ages of 2 and 6 may participate~     if they will benefit clinically from undergoing apheresis.) Family members of patients and~     normal healthy volunteers will also be enrolled.~        -  For all adults and children weighing 55 pounds or more. Blood is drawn through a needle~          placed in an arm vein and circulated through a cell separator machine. The plasma and~          white cells are extracted, and the red cells are returned to the donor through a needle~          in the other arm. The procedure takes from 1 to 2 hours.~        -  For children weighing less than 55 pounds. One unit (1 pint) of blood is drawn through a~          needle placed in an arm vein, similar to donating a pint of whole blood. The red blood~          cells are separated from the rest of the blood and returned to the donor through the~          same needle. This procedure requires only one needlestick and takes about 30 to 45~          minutes to complete. In some circumstances, the procedure must be repeated one or more~          times in order to obtain large enough quantities of plasma or cells for study.~   "
228771|NCT00562588|"~     German stroke units are hesitating to use Aggrenox for secondary ischaemic stroke / transient~     ischaemic attack (TIA) prevention in a sub-acute treatment setting. They argue that clinical~     experience with sub-acute Aggrenox treatment is limited and poorly documented when compared~     with sub-acute acetylsalicylic acid (ASA) treatment. However, long term treatment (started~     after 3-6 months after stroke/TIA) with Aggrenox was safe and superior to ASA treatment in~     preventing recurrent strokes. There is no evidence for ASA to prevent from neurological~     progression after stroke during the first 3 months. Results from a cohort study suggest that~     starting Aggrenox within 72 hours after stroke predicts clinical improvement in the National~     Institute of Health Stroke Scale (NIHSS) at discharge from the hospital. Dipyridamole~     suppresses acute inflammatory responses to stroke.~      This study is designed to investigate the tolerability and efficacy of a secondary stroke~     prevention treatment with Aggrenox when initiated within 24 hours of stroke onset on a stroke~     unit compared to later initiation after a 7 day ASA treatment and outside off a stroke unit~     setting.~   "
228772|NCT00562575|"~     The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects~     with high triglycerides.~   "
230711|NCT00536653|"~     The aim of this study is to determine the long term effects of two types of hormonal~     treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on~     the bone mineral density of patients.~   "
228773|NCT00562562|"~     This is a pilot project intended to determine the feasibility of detecting soft tissue~     changes in response to osteopathic manipulative treatment (OMT). MRIs of the lumbar and~     pelvic regions of low back pain (LBP) patients will be taken once before and at two different~     time points after OMT. Images obtained will be quantitatively analyzed for changes in the~     volumes of back muscles and for changes (T2 signals) indicative of activity levels or~     pathological conditions. Electromyography (EMG) will be used as an independent measure of~     back muscle activity for comparison with MRI results.~   "
228774|NCT00562549|"~     The purpose is to determine the effective dosage and to study the effects of this dosage~     taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.~   "
228775|NCT00562536|"~     The overall objective of the present study is to examine the effects of delayed umbilical~     cord clamping in preterm infants on neonatal outcomes using a prospective randomized~     controlled trial comparing immediate cord clamping (standard at present) with delayed cord~     clamping.~      Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping~     improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late~     onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to~     be examined include improvements in the following: 1) lung function as assessed by oxygen~     dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as~     assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring~     intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need~     for transfusion during stay in the NICU, and number of transfusions.~   "
228776|NCT00562523|"~     The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken~     daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the~     safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at~     specific times after taking the medications.~   "
228777|NCT00562510|"~     This is a Phase 3, randomized, double blinded, placebo-controlled study designed to compare~     the safety, tolerability, antiviral activity and immunological effect of raltegravir added to~     a previously stable HAART regimen in the treatment of HIV-1 infected subjects with~     undetectable viraemia and low CD4 recovery.~      HYPOTHESIS:~      Adding raltegravir to a stable HAART in patients with undetectable plasma viral load and low~     CD4 recovery will result in further viral suppression and therefore higher CD4 recovery.~   "
228778|NCT00562497|"~     This is a Phase III, randomized, double-blind, placebo-controlled study to investigate the~     efficacy and safety of Prochymal™ versus placebo in combination with corticosteroids as~     initial therapy for acute GVHD. Corticosteroids have been the primary therapy for patients~     with previously untreated acute GVHD and the historical published data define an expected 35%~     complete response (CR) at Day +28 using this therapy.~   "
228779|NCT00562484|"~     This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza~     Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a~     population defined as being not at risk of severe complications following influenza~     infection.~   "
228780|NCT00562471|"~     The purpose of this study was to determine whether the adhesion prevention gel was safe to~     use, and was effective for the prevention/reduction of adhesion formation that typically~     occurs following gynecological surgery to remove myomas~   "
228781|NCT00562458|"~     To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with~     advanced breast cancer in whom a partial or complete response or stabilized disease were~     obtained with first line chemotherapy, by tumoral response assessment.~   "
228782|NCT00562445|"~     Observational study about the incidence of relative adrenal insufficiency in patients with~     cirrhosis and acute variceal bleeding; in patients with acute peptic gastrointestinal~     bleeding and without liver disease; and in patients with severe acute pancreatitis.~      This is a study using pharmaceutical specialties in the approved conditions of use.~   "
228783|NCT00562432|"~     The primary goal of this study is to assess the safety of Plexisyl-AF administered by direct~     application to the cardiac fat pads in patients undergoing coronary artery bypass grafting.~     Secondary goals of the study are to assess the potential response of Plexisyl-AF to reduce~     the occurrence of postoperative atrial fibrillation and assess the performance of the~     electrostimulator device to confirm the location of the epicardial fat pads (nerves). The~     occurrence of postoperative atrial fibrillation will be monitored by continuous cardiac~     monitoring.~   "
228784|NCT00562419|"~     RATIONALE: CT-322 may stop the growth of glioblastoma multiforme by blocking blood flow to~     the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     CT-322 together with irinotecan may kill more tumor cells.~      PURPOSE: This phase 2 trial is studying the side effects, tolerability, and efficacy of~     CT-322 when given alone and in combination with irinotecan to patients with glioblastoma~     multiforme.~   "
228785|NCT00562406|"~     The primary objective of this pilot study is to compare the functional and anatomic outcomes~     of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon~     laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a~     combination of both.~   "
228786|NCT00562393|"~     The prevalence of obesity has reached epidemic proportions and is associated with the~     development of insulin resistance and type 2 diabetes (T2DM). A unifying theme has emerged~     over the past few years suggesting that lipid oversupply to metabolic organs responsible for~     glucose regulation leads to insulin resistance. Fitting with this, we and others have shown~     that increased lipid accumulation within skeletal muscle and/or liver is associated with~     impaired glucose uptake. However, the underlying mechanisms that mediate changes in muscle~     lipid metabolism are not yet known. The overall aim of this project is to examine metabolic~     effects of experimental weight gain in lean and overweight individuals with and without a~     genetic predisposition to type 2 diabetes. We hypothesise that lean subjects will increase~     fatty acid oxidation and upregulate mitochondrial oxidative capacity in muscle following~     overfeeding to protect against body weight gain and insulin resistance, but overweight~     subjects with a genetic predisposition to T2DM will have a defect in this ability.~   "
229262|NCT00555932|"~     Our overall aim is to examine if ultrasound is as accurate as MRI and/or CT in the evaluation~     of dural venous sinuses. We hypothesize that sonography will be accurate (accuracy >80%) for~     diagnosing specific anatomic findings of dural venous sinuses.~   "
228787|NCT00562380|"~     RATIONALE: Monoclonal antibodies, such as AMG-479, can block cancer growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help~     kill them or carry cancer-killing substances to them.~      PURPOSE: This phase I trial is studying the side effects and best dose of AMG-479 in treating~     patients with advanced solid tumors or non-Hodgkin lymphoma.~   "
228788|NCT00562367|"~     We propose to investigate structural and biochemical brain abnormalities in depressed~     subjects, and the relationship between the presence of such abnormalities and treatment~     outcome. We will recruit N=20 subjects with major depression disorder and N=20 matched normal~     controls. The depressed subjects would have previously not responded to an adequate trial~     with a selective serotonin reuptake inhibitor (SSRI). These depressed subjects will be~     treated for 4 weeks with the same SSRI antidepressant and with adjuvant triiodothyronine~     (T3). Structural magnetic resonance images (MRI) and then Phosphorus-31 magnetic resonance~     spectroscopic imaging (31P-MRSI) data will be obtained two times for each patient (at the~     beginning and at the end of the study) and one time for the normal controls. We will measure~     for each depressed subject the number of white matter hyperintensities (WMH); we will also~     measure the degree of change from baseline in several compounds characteristic for the~     cellular high-energy phosphate metabolism: the phosphocreatine/inorganic phosphate ratio and~     the beta-nucleoside triphosphate. We will compare the severity of WMH and the high-energy~     phosphate metabolism in two groups of depressed subjects (those responding and those not~     responding to thyroid hormone augmentation) and the normal controls.~      We hypothesize that:~        1. All depressed subjects, when compared with normal controls, will present lower baseline~          levels of compounds characteristic for the high-energy phosphate metabolism.~        2. Depressed subjects responding to T3 augmentation, when compared with subjects not~          responding to T3 augmentation, will present a larger increase of the high-energy~          phosphate metabolism.~   "
228789|NCT00562354|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the~     13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged >= 50~     years.~   "
228790|NCT00562341|"~     The proposed prospective study aims to determine whether interpretation of PSA levels in~     morbidly obese men require correction due to the obesity itself. If PSA levels are found to~     rise after weight loss, interpretation of PSA levels in morbidly obese men may be improved by~     upward correction of the PSA level. A 'correction factor' may be proposed for the~     interpretation of PSA levels in obese men, toward the clinical decision regarding indication~     for prostate biopsy.~   "
228791|NCT00562328|"~     RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them.~     Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in~     bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may~     be an effective treatment for early-stage chronic lymphocytic leukemia.~      PURPOSE: This phase II trial is studying the side effects of giving rituximab and alemtuzumab~     together with GM-CSF and to see how well it works in treating patients with early-stage~     chronic lymphocytic leukemia.~   "
228792|NCT00562315|"~     Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence,~     and lead to better characterization of disease status in restaging patients.~      This is a study that will test a compound (chemical substance) that has a small amount of~     radioactivity attached to it. This substance has a natural tendency to go to prostate tissue.~     The substance is called [18]FACBC and it is given in the form of an injection into a vein.~     After the substance reaches the prostate, scans called PET or Positron Emission Tomography,~     are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is~     used for PET scans but this substance is eliminated by the kidneys and cannot reach the~     prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow~     tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on~     the prostate is cancer with scans or x-rays that are usually done.~      Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the~     conventional imaging for prostate cancer. Investigators will be blinded of the intervention.~      This study will look at how the [18]FACBC goes into the prostate tissue and determine its~     ability to detect recurrent prostate cancer.~   "
228793|NCT00562302|"~     BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the~     Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures~   "
228794|NCT00562289|"~     A patent foramen ovale (PFO) is found more frequently in patients with an ischemic stroke~     than in control subjects.~      Therapeutic options to prevent stroke recurrence include antiplatelet drugs, oral~     anticoagulants, and transcatheter closure of the foramen. However, there are no published~     studies showing convincingly the superiority of any one of these strategies in preventing~     stroke recurrence.~      The aim of this randomized clinical trial is to assess whether chronic anticoagulation on the~     one hand and transcatheter on the other hand are superior to chronic antiplatelet therapy in~     preventing stroke recurrence.~   "
228795|NCT00562276|"~     The purpose of this multi-center clinical trial is to evaluate the safety and effectiveness~     of inserting an intrauterine device (IUD) immediately after a suction aspiration procedure~     compared to inserting the IUD 2-6 weeks after the procedure. This study will also evaluate~     how satisfied women are with the timing of their IUD placement. Subjects will be able to~     choose between the Paraguard IUD or the Mirena IUD.~      The researchers hypothesize that:~        1. the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with~          immediate insertion compared with delayed insertion,~        2. satisfaction and tolerance of side effects will be higher with immediate IUD insertion~          compared with delayed insertion, and~        3. overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with~          immediate IUD insertion compared with delayed insertion.~   "
228849|NCT00561548|"~     The aim of this research is to study Crohn disease patients before and after anti-TNF, the~     cooperation between lamina propria T-lymphocytes and macrophages, through the expression of~     co-signalisation molecules and their ligands, the production of cytokines participating in~     this cooperation, and the potential role of regulatory T lymphocytes.~   "
246372|NCT00328367|"~     The purpose of this study is to determine whether aripiprazole augmentation is safe and~     effective in the treatment of clozapine-treated patients with refractory schizophrenia.~   "
228796|NCT00562263|"~     The current study aims to investigate the impact of a comprehensive, team-based,~     family-centered, lifestyle modification program on body weight, metabolic abnormalities,~     fitness measures, and self-esteem in overweight adolescents beginning the study at ages 11-18~     years. The intensive program will uniquely include a team structure and a component~     designed to address the role of parental modeling in effective lifestyle changes. By~     comparing the demographic, psychosocial, and metabolic characteristics of adolescents~     according to the degree of weight loss, the study will also more fully characterize the~     barriers that prevent successful participation in an intensive lifestyle modification~     program.~   "
228797|NCT00562250|"~     The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the~     effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and~     tolerability of dapagliflozin with be assessed alone and while taking glimepiride~   "
228798|NCT00562237|"~     Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant~     concentrations will be tested for their safety and capacity to induce a specific immune~     response.~   "
228799|NCT00562224|"~     To determine the highest dose of study drug that can be taken without causing serious side~     effects in patients with advanced cancer. The study will look at safety of the study drug and~     whether the treatment schedule is tolerated by patients.~   "
228800|NCT00562211|"~     A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been~     developed and is tested in this study (LidoDyn).~      The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic~     agent (EMLA crème).~   "
228801|NCT00562198|"~     This is an open, randomised, active-controlled, 2-period crossover study comparing the effect~     of single doses of Stalevo 200 and Sinemet on striatal (putamenal and caudate) 11C-raclopride~     BP in PD patients with wearing-off symptoms. The study consists of 4 visits: a screening~     visit (visit 1), 2 treatment periods (period 1=visit 2, period 2=visit 3) separated by a~     minimum wash-out period of at least 3 days, and an end-of-study visit (visit 4). Subjects~     will be randomly allocated to start the period 1 with a single dose of Stalevo 200 or~     Sinemet. After the wash-out the study drug on period 2 will be administered according to a~     crossover design.~   "
228802|NCT00562185|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving doxorubicin together with carboplatin may kill more tumor cells.~      PURPOSE: This phase I and phase II trial is studying the side effects and best dose of~     carboplatin when given together with doxorubicin to see how well it works in treating~     patients with recurrent ovarian cancer.~   "
228803|NCT00562172|"~     Primary objective:~      To compare long-term glycemic control and preservation of beta cell function when basal~     insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients~      Secondary objective:~      To assess the change of insulin resistance, microvascular complication incidence, patient~     satisfaction with treatment~   "
228804|NCT00562159|"~     This purpose of this study is to determine the efficacy and safety of a grass sublingual~     (under-the-tongue) tablet.~   "
228805|NCT00562146|"~     The success rate of unguided nasojejunal feeding tube insertion will be determined in acute~     brain injured patients. Factors influencing tube self-progression will be evaluated.~   "
228806|NCT00562133|"~     The primary objective of the study is to evaluate the postprandial time course of~     nitrotyrosine after injection of insulin glulisine compared with regular human insulin.~      The secondary objectives are to evaluate the postprandial time course of the following~     efficacy parameters after injection of insulin glulisine compared with regular insulin on~        -  Blood Glucose~        -  Insulin~        -  Intact proinsulin~        -  Asymmetric dimethylarginine (ADMA)~        -  Metal matrix proteasis (MMP-9)~        -  Oxidative status (per ox)~        -  Interleukin 18 (IL-18)~        -  Free fatty acids (FFA)~        -  Oxidised LDL (ox-LDL)~        -  Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37)~        -  Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)~   "
228807|NCT00562120|"~     An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A~     nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic~     rhinometry will be used to measure the congestion.~   "
228808|NCT00562107|"~     The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony~     2550 or REPLY DR in a wide range of pacemaker patients.~      The expected benefits will be a result of the reduction of the percentage of ventricular~     pacing.~      It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence~     of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits~     are a result of spontaneous ventricular activation which ensures a more physiological~     ventricular activation.~      The benefits will be assessed by comparing the incidence of atrial arrhythmias and the~     evolution of the haemodynamic status of the patients (QOL, echo and BNP)~   "
228809|NCT00562094|"~     The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on~     symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive~     gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep~     disorders.~   "
228810|NCT00562081|"~     Patients with asthma can be effectively treated using an Internet-based management system as~     demonstrated by:~        1. Physician utilization (emergency department visits and unscheduled physician visits).~        2. Health-related quality of life scores.~        3. Global health care costs.~        4. Frequency of severe exacerbations and time to first exacerbation.~        5. Asthma control days.~        6. Patient education.~      Effective patient education will be associated with decreased markers of inflammation and~     improved indices of airways function.~   "
228811|NCT00562068|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from growing. Giving alemtuzumab together with combination chemotherapy may kill more~     cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when~     given together with combination chemotherapy and to see how well it works in treating~     patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.~   "
228813|NCT00562042|"~     Hypothesis: Increases in CRP, trop T, and BNP values will correlate significantly with right~     heart failure on echocardiogram and with mortality, ICU stay, hospital stay, and escalations~     in care.~        1. Evaluate whether CRP, trop T, and BNP correlate significantly with right heart failure~          on echocardiogram.~        2. Evaluate whether CRP, trop T, BNP, and echocardiogram correlate significantly with~          clinical outcomes: mortality, ICU stay, hospital stay, and escalations in care.~        3. Compare each test's correlation with clinical outcomes to the others, to determine which~          test provides the best risk ratio.~        4. Compare each trop T value's correlation with echo findings and clinical outcomes to~          determine the optimal time to draw trop T levels on a patient presenting with acute PE.~        5. These tests will not be used in an attempt to establish a diagnosis of PE.~   "
228814|NCT00562029|"~     Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose~     and HbA1c in the abscence of medication support is possible with a surgical procedure named~     the Duodenal-Jejunal Bypass (DJB) a modification of an established duodenal switch~     procedure and is performed utilizing the laparoscopic approach.~   "
228815|NCT00562016|"~     The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the~     composite rate of major adverse events during and after the PCI procedure.~   "
228816|NCT00562003|"~     The primary purpose of this study is to determine the maximally tolerated dose and spectrum~     of toxicities encountered with intraperitoneal delivery of a RGD modified conditionally~     replicative adenovirus (Ad5-Delta 24RGD) in patients with recurrent ovarian cancer.~      Secondary objectives :~        -  To determine the biologic effects encountered with intraperitoneal delivery of Ad5-Delta~          24RGD in patients with recurrent ovarian cancer cells~        -  To determine immunologic response generated against Ad5-Delta 24RGD when administered~          intraperitoneally to patients with recurrent ovarian adenocarcinoma~        -  To determine potential clinical activity of Ad5-Delta 24RGD when administered~          intraperitoneally to patients with recurrent ovarian adenocarcinoma~   "
228817|NCT00561990|"~     CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER~   "
228818|NCT00561977|"~     We hypothesize that adding beneficial high fiber foods to the diet will result in better~     overall dietary quality (measured by the Alternate Healthy Eating Index), which has been~     shown to be associated with cancer, than either reducing saturated fat, or a combination of~     high fiber and low saturated fat.~   "
228819|NCT00561964|"~     To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with~     type Ⅱdiabetes mellitus.~   "
228820|NCT00561951|"~     To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive~     bladder.~   "
228821|NCT00561938|"~     Confocal laser endomicroscopy (CLE) is a new diagnostic technique that allows microscopic~     examination of the digestive mucosa during ongoing endoscopy. Different types of tissue and~     diseases can be diagnosed immediately, and analysis of the in vivo microarchitecture is~     helpful to better target standard biopsies and reduce the number of biopsies required. CLE~     necessitates an intravenous injection of a fluorescent marker, e.g. fluorescein, to obtain~     'optical biopsies' with a high level of magnification (up to 1000 fold). To date, more than~     1000 endomicroscopy procedures have been performed in the world and different publications~     have shown the safety, feasibility and excellent diagnostic yield of CLE. No complication~     related to IV injection of fluorescein has been reported. However, all these data come from a~     very limited number of expert centres and need to be confirmed and validated at the~     multicenter level. The aims of this multicenter trial are: 1) to standardize CLE in all~     centres equipped in France, 2) to ensure the safety of intravenous fluorescein injection, 3)~     to test the diagnostic value of CLE in various conditions representative of the large~     spectrum of different cancerous and non-cancerous digestive diseases.~   "
228822|NCT00561925|"~     The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine~     extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR)~     in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary~     objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.~   "
228823|NCT00561912|"~     Primary Objective:~        -  To determine the progression-free survival (PFS) times for patients with advanced renal~          cell carcinoma (RCC) treated with decitabine and interferon alfa-2b.~      Secondary Objectives:~        -  To determine the toxicity of the combination of decitabine and interferon alfa-2b at the~          proposed dose and schedule in patients with advanced RCC~        -  To determine overall response by Response Evaluation Criteria in Solid Tumors (RECIST)~          criteria for patients with advanced RCC treated with decitabine and interferon alfa-2b.~        -  To determine the overall survival times for patients with advanced RCC treated with~          decitabine and interferon.~        -  To study the effects of decitabine and interferon alfa-2b on DNA methylation and gene~          expression in patients' tumor and non-tumor tissues and their correlation with clinical~          outcomes.~        -  To characterize the modulation of cellular immunity induced by the combination of~          decitabine and interferon alfa-2b in patients with advanced RCC and to correlate these~          results with clinical outcomes.~   "
228824|NCT00561899|"~     Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without~     compromising the development of malaria immunity or encouraging drug resistance. The effect~     of IPT in children in the prevention of malaria has been evaluated in a number of trials in~     areas of seasonal malaria transmission. Results from these trials have shown that IPTc~     provided between 40% - 86% protection against clinical malaria. In 2006, a trial that~     compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia.~     Preliminary results of the trial have shown that the treatment was very effective as only 4%~     (45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic.~     Tolerability was assessed in a subset of 1100 children and the results showed that about~     13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of~     the study subjects. Severe adverse events were rare. Thus it is important to investigate if~     other drug regimens might be equally effective in preventing malaria but less likely to cause~     adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years~     will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or~     Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions~     during the months of September, October, and November. To determine the prevalence of side~     effects following drug administration participants in each treatment group will be visited at~     home three and seven days after each round of drug administration and a side effects~     questionnaire completed. To help establish whether these adverse events are drug related, the~     same questionnaire will be administered after each treatment round, to 286 age-matched~     children who are not part of the trial. The primary ends points will be the incidence of~     adverse events.~   "
228825|NCT00561886|"~     Chronic obstructive bronchitis and emphysema (COPD) are pathophysiologically characterized by~     inflammatory and structural changes in the lung. These changes lead to a reduction in elastic~     recoil as well as reduction in lung parenchyma. As a consequence collapse of the small airway~     occurs during expiration leading to expiratory flow limitation. In severe cases this flow~     limitation occurs even during resting condition. This expiratory collapse is suspected to~     mask changes in bronchial smooth muscle tone, especially if these changes in bronchial smooth~     muscle tone are assessed using expiratory manoeuvres. This might leave the impression of~     non-reversible airway obstruction und ineffectiveness of treatment with bronchodilators.~     Several studies suggest that in patients with COPD symptomatic changes following application~     of a bronchodilating compound do not correlate with changes in forced expiratory volumes. In~     contrast inspiratory lung function parameters (especially forced inspiratory volume in one~     second (FIV1)) is much more associated with symptomatic changes in patients with COPD.~     Comparable effects were also detected regarding peak inspiratory flow (PIF) values.Changes in~     inspiratory parameters following administration of a bronchodilator in patients with COPD and~     asthma are reproducible. PIF can easily be measured by inspiratory peak flow meters. So far~     no data exists on the usability of these devices following bronchodilation in patients with~     COPD. Formoterol is a rapid acting bronchodilator, which has been proven save in asthma and~     COPD~   "
228826|NCT00561873|"~     Determination of efficiency of nimotuzumab in children with high grade glioma.~   "
228827|NCT00561860|"~     Although continuous positive airway pressure (CPAP) is an effective therapy for obstructive~     sleep apnea-hypopnea (OSAH), one of the major impediments to its use is poor compliance.~     Adherence with CPAP ranges from 50% to 75%, and subjective reports underestimate actual use.~     The primary objectives are to determine whether a remote monitoring system improves 3 month~     compliance (average hours of use/night), and reduces the costs of caring for patients with~     OSAH who are prescribed CPAP.~   "
228828|NCT00561834|"~     The purpose of this study is to explore the safety and efficacy of ranibizumab to treat~     non-arteritic ischemic optic neuropathy based on clinical and anatomical findings.~   "
228829|NCT00561821|"~     This study was conducted to investigate the efficacy of treatment with Org 50081~     (Esmirtazapine)~      compared to placebo in elderly participants with chronic primary~      insomnia. Primary efficacy variable is Wake time After Sleep~      Onset (WASO), averaged over all in-treatment time points~      and measured by polysomnography (PSG).~   "
228830|NCT00561808|"~     Retrieval of immature oocytes from women with polycystic ovaries, their in-vitro maturation,~     fertilization and embryo transfer can prevent hormonal treatment that can lead to ovarian~     hyperstimulation. In addition, it can decrease discomfort and side-effects of routine daily~     administration of hormones and it can be cost-effective. Thirty healthy women with Polycystic~     Ovarian Syndrome aged 20-35, with BMI 18-30 kg/msq will be included in the study. Their~     immature oocytes will be retrieved from small follicles without any hormonal treatment. The~     oocytes will be fertilized post in-vitro maturation. The developed embryros will be~     transferred to the patients as in a routine IVF cycle.~   "
228831|NCT00561795|"~     This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and~     tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects~     with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior~     therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled.~     Dose schemas for each study arm are described in the protocol. For each arm, six subjects~     will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial~     toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose~     limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of~     study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen~     125 (CA-125) responses.~   "
228832|NCT00561782|"~     The goal of this study is to compare the changes that occur in sensation and chemical~     properties of the brain following SCI between individuals that experience chronic pain and~     those that do not, and between those with SCI and the able-bodied.~   "
228833|NCT00561769|"~     Commencing of growth hormone in luteal phase when follicular cohort for the next cycle is~     being gathered may increase mature oocytes in poor responder~   "
228834|NCT00561756|"~     RATIONALE: Vaccines made from mouse DNA may help the body build an effective immune response~     to kill cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of mouse DNA vaccine~     in treating patients with recurrent B-cell lymphoma.~   "
228835|NCT00561743|"~     The purpose of this study is to determine whether doxorubicin HCL liposome injection,~     bortezomib, and Dexamethasone in combination, are effective in previously untreated multiple~     myeloma patients. Bortezomib inhibits the function of proteasomes, a novel mechanism of~     action.~   "
228836|NCT00561730|"~     The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg~     and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive~     gastroesophageal reflux disease) in clinical practice. During the study, the patients had to~     complete a short version of a patient-orientated, self-assessed reflux questionnaire~     (ReQuest™ in Practice).~   "
228837|NCT00561717|"~     Finding out how fast azelastine nasal spray works in subjects with hay fever.~   "
228838|NCT00561704|"~     Insulin resistance typically characterizes type 2 diabetes (T2DM) and prediabetic states and~     is the prominent feature of the metabolic syndrome.Adiponectin plays an important part in~     glucose metabolism,insulin resistance, the deterioration of renal function.we hypothesize~     there is a difference serum adiponectin levels between obese and non-obese women with type 2~     diabetic nephropathy. Furthermore, these two groups would respond difference to the RAs~     blocker(Losartan).~   "
228839|NCT00561691|"~     Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine glioma.~   "
228850|NCT00561535|"~     Probiotics may improve symptoms in IBS patients. The aim of this study is to test the~     efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome~     III criteria.~   "
228851|NCT00561522|"~     The purpose of this study is to determine whether capecitabine is effective to prevent~     disease recurrence after curative hepatic resection in patients with hepatocellular~     carcinoma.~   "
228840|NCT00561678|"~     Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration~     of brain function including the development of postoperative delirium (PD) and postoperative~     cognitive dysfunction (POCD). These disorders cause disability, distress for both patients~     and their families, are associated with other medical complications and account for~     significant additional health care costs. We currently use relatively primitive approaches to~     preventing and treating PD and POCD.~      Dexmedetomidine is a drug used for sedation in critically ill patients that provides some~     pain relief and controls the bodies response to stress. The sedation produced by~     dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia~     and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium~     following cardiac surgery and the developing understanding of the causes of PD and POCD~     suggest that dexmedetomidine will be particularly effective.~   "
228841|NCT00561652|"~     As a needed first step prior to a planned full-scale RCT, in order to assess the feasibility~     of the RCT and refine its design and protocols, we will perform a pilot study with the~     following objectives:1.To assess whether enough veterans with chronic LBP can be identified,~     meet eligibility criteria and be randomized to demonstrate that recruitment for a planned~     full-scale RCT is feasible. 2.To assess whether veterans with chronic LBP will adhere to~     protocol interventions per study protocol. 3.To assess whether veterans with chronic LBP will~     complete data collection per study protocol. 4.To obtain estimates of effect sizes and the~     corresponding standard errors of the primary efficacy outcome measures to estimate the~     required sample size of a planned full-scale RCT.~   "
228842|NCT00561639|"~     A SpetiFast multiplex PCR kit has recently been placed on the market witch can evidence the~     DNA of 90% of micro-organisms (bacteria and fungus) implicated in sepsis. However, the~     clinical impact of being able to detect the DNA of these various agents is unknown. We~     propose to assess the benefit to patient care of the SeptiFast multiples PCR by answering~     three questions : 1/in patients with septic immunosuppression, does this kit evidence~     etiologic agents not revealed by classical methods? 2/Does the use of PCR results permit~     different diagnostic hypotheses to be considered? 3/Does having the SeptiFast results entail~     changes to the therapeutic plan?~   "
228843|NCT00561626|"~     Rationale: The prevalence of the metabolic syndrome is strongly increasing in developed~     countries. The role of the small intestine seems important in the development of the~     metabolic syndrome. Although it is known that a high-fat Western-style of diet has~     deleterious effects on (post-prandial) lipidemia and glucose homeostases, effects of such a~     diet on the small intestine is not known. To elucidate the role of the small intestine on the~     early development of the metabolic syndrome, the effects of a high-fat (HF) and a low-fat~     (LF) diet will be examined on gene expression in the small intestine and early biomarkers in~     blood of healthy subjects.~      Objective: The objective of this study is to compare in healthy subjects the effects of a HF~     diet (40 En% fat) with those of a LF diet (20 En% fat) on early biomarkers and parameters of~     metabolic stress in blood and on expression of genes in the small intestine.~      Additional research objectives are:~        -  To compare the diet-induced changes in transcriptome profile of the small intestine with~          more easily accessible peripheral blood mononuclear cells (PBMC)~        -  To establish effects of HF and LF diet on basal gut permeability and after a~          chenodeoxycholic acid (CDCA) load (second hit).~      Study design: Randomised crossover design. The duration of the experimental periods (HF and~     LF diet) will be 28 days, separated by a wash out period of at least 3 weeks. At day 21 of~     each intervention period a postprandial test will be performed and duodenum biopsies will be~     taken. At day 25 and 28 of each intervention period, respectively, basal gut permeability and~     gut permeability after a CDCA load will be determined with a sugar recovery test.~      Study population: Ten healthy men in the age of 18-60 years, without a history of any~     gastrointestinal disorders or complaints.~      Intervention: Subjects will consume in random order:~        -  a HF diet (40 En% fat, 45 En% carbohydrates and 15 En% proteins)~        -  a LF diet (20 En% fat, 65 En% carbohydrates and 15 En% proteins)~      Primary study parameters/endpoints: Potential early biomarkers of the metabolic syndrome in~     blood and gene expression profiles in the small intestine.~      Secondary study parameters/endpoints: Parameters of the metabolic syndrome in blood, gene~     expression profiles in PBMC and gut permeability.~   "
228844|NCT00561613|"~     This was a Phase I multi-center, randomized study in 40 healthy, sexually active women not at~     risk for pregnancy due to previous female sterilization. The male partners of the~     participants were consented to participate in the study. The clinician evaluating the~     cervical mucus for midcycle characteristics and presence of sperm was blinded as to gel used.~     The product tested was the SILCS diaphragm with Gynol II (spermicide) and the SILCS diaphragm~     with KY Jelly (lubricant). The sequence of diaphragm and gel use was determined by~     randomization. The study was conducted at two centers, Magee-Womens Hospital in Pittsburgh,~     Pennsylvania and CONRAD's Clinical Research Center at the Eastern Virginia Medical School in~     Norfolk, Virginia.~      The study consisted of a screening visit, a baseline cycle, and up to 2 cycles of post-coital~     tests (PCTs) for a total of 7 visits. The first PCT was a baseline PCT, performed without the~     use of any product, in order to demonstrate the subject's ability to produce receptive,~     midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating~     the cervical mucus was evaluated in this cycle. Test PCTs were carried out during the second~     and third menstrual cycle using either the SILCS diaphragm with N-9 or the SILCS diaphragm~     with lubricant. Cycles were repeated depending on the characteristics of the cervical mucus~     and the number of sperm found in the vaginal pool and endocervical specimens; thus, some~     women may undergo more than three PCTs. An additional test cycle with a modified polymer~     spring device was performed in a subset of participants.~      Colposcopy was performed during the mucus check and post-coital test visits in all three~     cycles in order to document the baseline condition of the vagina and cervix pre- and~     post-intercourse and, in test cycles, to note the effect of product.~      Vaginal samples were taken from the posterior fornix of the vagina and the cervical os at~     each visit during the baseline and test cycles to measure for the presence of PSA.~   "
228845|NCT00561600|"~     The primary objective of this investigation is to evaluate the clinical and radiographic~     outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a~     28mm or 36mm ULTAMET™ metal insert.~   "
228846|NCT00561587|"~     Due to Quetiapine's particulars and the promising receptor profile, we want to examine the~     efficacy concerning relapse prevention of alcoholics suffering from persisting craving and/or~     affective symptoms (persisting sleep disorder, persisting excitement, persisting depressive~     symptoms, persisting anxiety symptoms) in comparison to matching placebo in a double-blind~     pilot study.~      We further want to compare the course of the above mentioned craving and affective symptoms~     under medication with quetiapine / matching placebo.~   "
228847|NCT00561574|"~     The current study is a 52-week safety study in elderly outpatients with chronic primary~     insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH~     900265, MK-8265) to investigate the safety and tolerability of long-term treatment with~     esmirtazapine in elderly patients.~   "
228848|NCT00561561|"~     This study is looking at problems people sometimes have taking in information from their~     senses. Specifically, we are comparing the way in which people diagnosed with schizophrenia~     process sound information, compared with people who have never been diagnosed with a~     psychiatric disorder. When people hear a loud sound they sometimes feel startled, and when~     they feel startled they usually blink their eyes. However, if they hear a softer sound~     shortly before the loud one they may not blink their eyes - in other words, the eye-blink~     response is smaller. When this happens it's called prepulse inhibition of startle. In this~     study, we want to measure the startle response and prepulse inhibition of startle in~     individuals diagnosed with schizophrenia versus individuals not diagnosed with schizophrenia.~     We also want to find out whether people show the same amount of prepulse inhibition of~     startle as other members of their family.~   "
228852|NCT00561509|"~     In usual clinical conditions, depressed patients with no sexual dysfunction, after signing~     their consent for the dissemination of their clinical information will begin their treatment~     with any SSRI or a Dual antidepressant as per the best clinical decision of their treating~     psychiatrist. Sexual dysfunction will be identified along the 6 months of active observation.~     Psychiatrists will decide to change dose, augment, shift or combine antidepressants at their~     clinical discretion in the benefit of their patients and all clinical decisions will be~     recorded.Comparisons among antidepressants will be made in terms of their sexual dysfunction~     potentiality.~   "
228853|NCT00561496|"~     This is a multi-center, pharmacokinetic study involving a single-dose phase, a wash out phase~     and a two-week once or twice-daily dosing phase for each of 49 volunteers.~      In the single-dose phase, each volunteer will apply the single dose in the clinic.~     Participants will be randomized to have cervicovaginal samples and biopsies collected at one~     of seven time-points [0.5, 1, 2, 4, 6, 8, and 24 hour(s)] after the single-dose. Blood~     samples will be drawn at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) after the single-dose.~      In the two-week phase, the study supplies will be distributed and the participants will be~     randomized to apply each dose either once or twice-daily for two weeks. At the one week~     follow-up visit a blood sample will be drawn prior to the morning dose to obtain a trough~     value and cervicovaginal samples will be collected four hours after the morning dose. At the~     two week follow-up visit blood samples will be drawn prior to the morning dose to obtain a~     trough value and then at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) from the final morning dose.~     Participants will be randomized to have cervicovaginal samples and biopsies collected at~     either 4, 8 or 24 hours after the final morning dose.~      Up to 10 participants who have completed the first two phases of the study, will be asked to~     participate in a third phase to have cervicovaginal samples, biopsies and blood samples~     collected 12 hours after a single-dose.~   "
228854|NCT00561483|"~     Renal Compromise after treatment of decompensated heart failure with diuretics is not~     uncommon. The purpose of our study is to investigate the relationship between cystatin C and~     worsening renal function in this setting. Cystatin C is a biomarker produced at a constant~     rate by all cells that is a sensitive biomarker of renal function.Cystatin C and Plasma amino~     terminal proB-type natriuretic peptide (NT-proBNP) levels will be obtained at baseline and~     daily. Our goal is to enroll 100 subjects with an estimated 5 samples per each subject. The~     time course of changes in cystatin C in relation to serum creatinine levels over time will be~     plotted.~      Our hypothesis is that sequential changes in cystatin C levels following initial treatment~     with diuretic therapy in the setting of acute decompensated heart failure may provide early~     insight into cardio-renal compromise. Understanding the natural history and time course of~     the changes in sequential cystatin C levels may facilitate further studies to guide the~     judicious use of diuretic therapy in acute decompensated heart failure, and to predict the~     risk of subsequent development of worsening renal function. If serial testing of cystatin C~     can provide accurate assessment and prediction of worsening renal function, clinical~     applications of these observations can be evaluated in future prospective studies.~   "
228855|NCT00561470|"~     The main objective of the study was to evaluate the effectiveness of aflibercept (versus~     placebo) in increasing the overall survival in participants with metastatic colorectal cancer~     treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously~     failed an oxaliplatin based treatment for metastatic disease.~      The secondary objectives were to compare progression-free survival, to evaluate overall~     response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV)~     aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.~   "
228856|NCT00561457|"~     To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication~     of treatment of common and/or external iliac artery occlusive disease~   "
228857|NCT00561444|"~     The goal of this behavioral research study is to look at patients' quality of life after~     treatment or management for prostate cancer.~   "
228858|NCT00561431|"~     In the last three decades, the mortality associated with acute renal failure (ARF) in the ICU~     has remained unchanged at greater than 50%, despite improvements in dialysis technology.~      The primary objective is to determine whether Continuous Veno-Venous Hemodiafiltration~     (CVVHDF) using an ultrafiltration rate of 35 ml/hr/kg (high dose) leads to a greater~     reduction in all-cause ICU mortality compared to standard CVVHDF using an ultrafiltration~     rate of 20 ml/hr/kg.~   "
228859|NCT00561418|"~     RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth, and may stimulate the immune system to stop cancer cells from~     growing.~      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat after~     stem cell transplant in treating patients with high-risk lymphoma.~   "
228860|NCT00561405|"~     Stroke is a major cause of disability in Canadian adults. Following a stroke, many people~     have difficulty walking in their home and in the community. The purpose of this study is to~     compare the effect of two different approaches to walking retraining in people who have had a~     stroke.~      Individuals living in the community who have had recently had a stroke will be asked to~     participate in this study. Participants will be randomly assigned to one of two five week~     walking training programs. In one program, individuals will re-learn to walk in a variety of~     real-life situations. Practice sessions will encourage active problem solving by the~     participants. The other program will have participants practice walking on a treadmill while~     some of their body weight is supported by a special harness system. Participants will also be~     assisted by a physiotherapist to walk in a more normal manner.~      Participants' will be assessed at the beginning of the study, after the 5 week training~     program and again, eight weeks later. The research assistant will assess their ability to~     walk, their confidence level and the average daily walking activity.~      Primary Hypothesis: Individuals assigned to the Motor Learning Walking Program will improve~     their walking ability from baseline to follow up assessment significantly more than~     individuals assigned to the Treadmill Training Program.~      The results of this study will help physiotherapists plan effective treatment programs for~     individuals with walking difficulties following stroke. It will also give researchers~     direction for future studies in the areas of walking retraining and motor skill development~     post-stroke.~   "
228894|NCT00560963|"~     A dose finding study in locally advanced and/or metastatic pancreatic cancer patients~   "
228861|NCT00561392|"~     This study evaluated the safety and efficacy of 10 cm^2 rivastigmine patch in patients with~     Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who~     stayed on the target size of 10 cm^2 for at least 8 weeks. This proportion was then compared~     to historical data of the percentage of patients who could reach a rivastigmine capsule~     target dose of 12 mg and stay on it at least 8 weeks.~   "
228862|NCT00561379|"~     The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III~     or IV with 1 to 3 adverse prognostic factors according to the International prognostic index.~     Patients with eligibility criteria and who gave informed consent will be randomised between~     CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous~     stem cell support. The aim of the study is to compare the Event free survival between the two~     arms and to gain insight into the prognostic significance of several biological markers~     gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA~     profile and BCL é expression).~   "
228863|NCT00561366|"~     Arimoclomol is a small molecule that upregulates molecular chaperones in cells under~     stress. Arimoclomol extends survival by five weeks when given both pre-symptomatically and at~     disease onset in a mutant superoxide dismutase (SOD1) transgenic mouse model of ALS.~     Furthermore, it has been demonstrated to have neuroprotective and neuroregenerative effects~     in other rat models of nerve damage. Molecular chaperone proteins are critical in the~     cellular response to stress and protein misfolding. Recent data suggest that the SOD1~     mutation responsible for ALS in some patients with familial disease reduces the availability~     of a variety of molecular chaperones, and thus weakens their ability to respond to cellular~     stress. Protein misfolding and consequent aggregation may play a role in the pathogenesis of~     both the familial and sporadic forms of ALS. Therapeutic agents such as arimoclomol that~     improve cellular chaperone response to protein misfolding may be helpful in ALS.~   "
228864|NCT00561353|"~     The purpose of this study is to investigate how efficient TMC435350 will work against the~     Hepatitis C virus genotype 1 (genotypes refer to the genetic constitution of the virus) and~     what the concentrations of TMC435350 in the blood are with or without pegylated interferon~     alpha-2a (PegIFNa-2a) or PegIFNa-2a plus ribavirin.~   "
228865|NCT00561340|"~     The purpose of this study is to see if supplementing calories with Pediasure is effective in~     maintaining height, weight, and BMI percentiles for young children during 2 years of~     treatment with ADHD medication.~   "
228866|NCT00561327|"~     The purpose of this study is to determine whether losartan metabolites are effective in~     inducing PPARγ target genes in monocytes in losartan-treated patients.~   "
228867|NCT00561314|"~     RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the~     tumor without affecting the surrounding tissue.~      PURPOSE: This phase II trial is studying the side effects and how well highly focused~     ultrasound energy works in treating patients with localized prostate cancer.~   "
228868|NCT00561301|"~     - To evaluate the feasibility of combination chemotherapies comprising of~     gemcitabine-dexamethasone-oxaliplatin for patients with refractory or relapsed malignant~     non-Hodgkin lymphoma (NHL)~   "
228869|NCT00561288|"~     The purpose of the study is to investigate whether ingestion of acetaminophen reduces the~     experience of hurt feelings.~   "
228870|NCT00561275|"~     This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients~     with esophageal cancer.~   "
228871|NCT00561262|"~     RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by~     heating them without affecting normal tissue.~      PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation~     therapy works in treating patients with localized prostate cancer.~   "
228872|NCT00561249|"~     At the time of transfer of frozen/thawed embryos in human IVF/ICSI, patients are randomized~     between study and control group.In the control group no additional intervention takes place~     on the embryos to be transferred,in the study group, embryos for transfer are subjected to~     laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two~     minutes per embryo.~   "
228873|NCT00561236|"~     The use of intravitreal corticosteroids in the management ocular inflammatory diseases has~     recently gained widespread acceptance. The purpose of this study is to determine if the use~     of intravitreal triamcinolone is associated with suppression of endogenous cortisol~     production, as generally admitted for patients treated with oral or parenteral corticosteroid~     therapy.~   "
228874|NCT00561223|"~     The investigators believe that iloprost will improve gas exchange in COPD patients with~     pulmonary hypertension.~   "
228875|NCT00561210|"~     Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune~     enhancing diet versus polymeric diet)in severe burn hospitalized patients .~   "
228876|NCT00561197|"~     This is a Phase 1/ 2, open-label, single-center study of preoperative chemoradiotherapy and~     AT-101 in patients with locally advanced esophageal or gastroesophageal junction cancer.~   "
228877|NCT00561184|"~     To assess persistence of antibody titers 17-18 months after primary immunization with two~     0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen,~     as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and~     Microneutralization (MN) test~   "
228878|NCT00561171|"~     This is a phase II a, double-blind, randomized, parallel-design, four-week study to~     investigate the efficacy, safety and tolerability of two different doses of SPP635 in type II~     diabetic patients with mild to moderate hypertension and albuminuria.~      The total study duration for patients completing the entire study will be approximately 7~     weeks including a 2 weeks Screening Phase, 1 week Wash-out Phase, 4 week Treatment Phase and~     1 week Follow-up Phase.~      All treatments other than certain antihypertensive drugs (which are to be washed-out) with an~     effect on BP and all antidiabetic treatments must be kept at stable dose during the whole~     study.~      A maximum of 50 patients in total is planned to be enrolled.~   "
228879|NCT00561158|"~     The purpose of the study is to develop and evaluate a dietary change program specifically for~     low-income, African-American women who are at risk for developing diabetes due to obesity.~     The program uses an innovative approach that emphasizes risk awareness, self-efficacy, and~     skills training through active learning exercises related to healthy eating. The program is~     delivered by peer educators in the community and addresses economic and cultural factors that~     are very important to program participants.~   "
228880|NCT00561145|"~     Over the past century life expectancy has risen rapidly. As a result, the proportion of~     elderly people continues to grow. Elderly people probably have an impaired regulation of~     energy balance (energy intake versus energy expenditure) whereby the underlying physiological~     mechanisms are not fully understood.~      The first objective of this study is to provide further evidence for an age-related failure~     to regulate energy balance in elderly. If the hypothesis of impaired regulation of energy~     balance in elderly is confirmed then the second objective becomes to elucidate the underlying~     physiological mechanisms of the age-related failure to regulate energy intake in elderly.~   "
228881|NCT00561132|"~     The purpose of this study was to evaluate if the vanadium can improve the insulin sensitivity~     in patients with impaired glucose tolerance. Secondary purpose of this study was to assess~     changes on metabolic profile, weight and blood pressure.~   "
228882|NCT00561119|"~     The primary goal of therapy in patients with metastatic breast cancer is palliation and~     prolongation of life with quality. Although there are no randomized trials comparing~     chemotherapy with supportive care in women with metastatic breast cancer, chemotherapy~     clearly provides a survival benefit in metastatic breast cancer. Due to diagnosis at earlier~     phases of metastatic disease and more effective therapies, the median survival of patients~     treated with modern taxane-based chemotherapy is now reaching approximately 2 years. The~     duration of chemotherapy in patients responding or stable disease remains controversial,~     since quality of life is not usually adversely affected and may even be improved in many~     patients receiving cytotoxic chemotherapy. In addition, many commonly used chemotherapeutic~     agents are not limited by cumulative toxicity in metastatic breast cancer patients. Several~     studies investigated the role of maintenance chemotherapy suggest that maintenance~     chemotherapy is associated with superior time to progression but no survival gain. However,~     these randomized trials did not incorporate taxane-based chemotherapeutic regimens, the new~     standard of care in metastatic breast cancer patients these days. A 1998 metaanalysis of~     1,986 patients randomly assigned between combination chemotherapy and single-agent therapy in~     metastatic breast cancer patients demonstrated a survival advantage to combination~     chemotherapy, with a hazard ratio of 0.82 (range, 0.75 to 0.90). Although there are several~     randomized trials showing negative results for survival gain in patients who received~     maintenance chemotherapy, the role of maintenance chemotherapy with newer agents, such as~     docetaxel or paclitaxel, have not been established yet. Although Italian MANTA trial~     demonstrated no difference in PFS or survival between the two arms, their metaanalysis~     advocated survival benefit of maintenance therapy. Since gemcitabine/paclitaxel (GP)~     combination chemotherapy is one of the two regimens which showed definite survival gain with~     favorable toxicity from a randomized trial, we plan to randomize patients who responded to~     six cycles of GP induction chemotherapy to receive additional maintenance GP chemotherapy~     until disease progression versus observation. We hypothesize that patients who receive~     maintenance GP chemotherapy will do better in terms of progression free survival.~   "
228883|NCT00561106|"~     Since steroids carry a moderate beneficial effect in Bell's palsy, and to address this~     question, valacyclovir was added to prednisone for the treatment of this condition.~   "
228884|NCT00561093|"~     Study of efficiency and safety of oral nutritional supplements with anti-inflammatory and~     antioxidative properties combined with an appetite stimulant with anti-inflammatory~     properties (pentoxiphylline) in treatment of malnutrition-inflammation-cachexia syndrome in~     maintenance hemodialysis patients~   "
228885|NCT00561080|"~     Primary objective:~      Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster~     virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month~     schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks~     post-vaccination~      Secondary objectives Immunogenicity~        -  To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen~          and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.~        -  To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen~          with the VZV antibody titres at 12 months after completion of each 2-doses regimen of~          ZOSTAVAX®~        -  To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose~          regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®~   "
228886|NCT00561067|"~     The purpose of this study is to evaluate the tolerability and efficacy of erythropoietin~     (EPO) treatment in spinal shock in comparison with the methylprednisolone treatment (MP).~   "
228887|NCT00561054|"~     Lung cancer is the leading cause of cancer deaths worldwide. It is estimated that, in 2004,~     173,700 new cases of lung cancer will be diagnosed in the United States alone and 164,440~     deaths due to this disease will occur(13) . NSCLC accounts for approximately 80% of all lung~     cancers. Among NSCLC cases approximately 30% present with locally advanced and 40% with~     metastatic disease (14,15) . In metastatic disease, chemotherapy is the treatment of choice,~     but benefits obtained in survival have been modest. Five-year survival is less than 15%,~     probably due to diagnosis at late stages. Surgical results in earlier stages are poor~     compared to other tumor types (about 40% of recurrence in stages I-II). Results of~     chemotherapy in advanced stages are also poor (one-year survival of 40%) (15,17). It is~     commonly accepted that the standard treatment for advanced disease (stage IV and IIIb with~     malignant pleural effusion) consists of platinum-based chemotherapy(15,16) . However, there~     are many open questions in the management of these patients, such as the role of 3-drugs~     combinations, non-platinum-based therapies, and new biologic therapeutics' approaches.~     Currently, in the treatment of advanced NSCLC response rates of about 20%-30% and median~     survival times of 6 to 11 months have been achieved (16, 17, 18, 19, 20, 21, 22,). Several~     combinations of drugs are used and show similar efficacy. Cisplatin plus vinorelbine or~     Cisplatin plus Gemcitabine are among the most commonly used regimens in the first-line~     therapy of NSCLC.~   "
228888|NCT00561041|"~     The study examines the relative efficacy of two active aftercare interventions (i.e.,~     face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient~     treatment for alcohol use disorders(AUD)~   "
228889|NCT00561028|"~     To test the association between anti-Chlamydia serum titers and anti-Mycoplasma antibodies~     with Acute Coronary Syndromes.~   "
228890|NCT00561015|"~     The purpose of this study is to assess the effect of telaprevir on early hepatitis~     (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who~     are chronically (lasting a long time) infected with genotype 2 or 3 HCV.~   "
228891|NCT00561002|"~     To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from~     healthy children receiving the 2007-2008 formulation of the inactivated, split-virion~     influenza vaccine Fluzone® for further study.~   "
228892|NCT00560989|"~     Granulomatous lung diseases are diseases in which inflamed clusters of white cells, known as~     granulomas, form in lung tissue. Chronic beryllium disease (CBD) and sarcoidosis are two~     granulomatous diseases that share similar clinical symptoms, physiological changes in the~     lungs, and immune responses to the disease. Genetic variations may make some people more~     susceptible to developing CBD or sarcoidosis. This study will identify common genetic regions~     associated with increased risk of developing the granulomatous diseases CBD and sarcoidosis.~   "
228893|NCT00560976|"~     The purpose of this study is to assess changes in serum levels of the siderophore binding~     protein NGAL by hemodialysis without and with intravenous iron administration~   "
228896|NCT00560937|"~     This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The~     goal of this placebo-controlled study is to provide preliminary efficacy data for potential~     pregnenolone effects on cognitive symptoms and negative symptoms in patients with~     schizophrenia. Depressive symptoms and positive symptoms will also be assessed.~   "
228897|NCT00560924|"~     This trial is conducted in Europe. The aim of this trial is to investigate the preventive~     effect of treatment with estradiol vaginal tablets on recurrent urinary tract infections~     (RUTI) in post-menopausal women with signs of urogenital ageing (UGA).~   "
228898|NCT00560911|"~     Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC).~     However, no study has yet assessed the safety and efficacy of OAC self-management in elderly~     patients with major thromboembolic and haemorrhagic complications as primary outcomes.~      In this multi-centre, open, randomised controlled trial, patients aged 60 years or will be~     randomised into a self-management or routine care group and followed up for at least two~     years.~      The primary hypothesis of the study is that self-management of oral anticoagulation is~     superior compared to routine control in terms of reducing thromboembolic events requiring~     hospitalisation and all major bleeding complications as the primary endpoint.~   "
228899|NCT00560898|"~     The purpose of this study is to measure the relative barrier function of the top layer of~     the cornea (called the epithelium), or the degree to which the cornea can prevent the~     penetration of the colored dye sodium fluorescein into the eye. This is a clinical~     investigation of the effect on corneal barrier function following wear of two contact lens~     materials and two contact lens care systems, approved for marketing in the US by the Food and~     Drug Administration. These contact lenses will be worn for two hours, following soak in one~     of two marketed contact lens disinfecting solutions. Approximately 25 young, adapted contact~     lens wearers will participate.~   "
228900|NCT00560885|"~     ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety~     and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation~     during concomitant on-pump cardiac surgery.~   "
228901|NCT00560872|"~     The purpose of this study is to evaluate the influence of remote magnetic catheter navigation~     on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid~     isthmus in patients with typical atrial flutter.~   "
228902|NCT00560859|"~     The purpose of this research is to determine the effect of adenotonsillectomy surgery~     (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children.~     OSAS can cause health problems including poor growth, high blood pressure, diabetes and~     behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for~     children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve~     afterwards. This study will help determine if improvement occurs or if it does not. It will~     also look at whether certain groups, such as children who are overweight or of different~     ethnicities, are helped by the surgery.~   "
228903|NCT00560846|"~     The aim of this study is to demonstrate the influence of peri-operative nutrition on the~     post-operative complications, preservation of lean body mass and length of stay after~     gastrectomy or oesophagectomy.~   "
228904|NCT00560833|"~     The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A~     receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be~     effective in reducing the number and intensity of hot flushes in preliminary trials. Also~     several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been~     investigated to manage hot flushes, confirming the role of the serotonergic system. In the~     present trial, the efficacy and safety of four different doses of esmirtazapine compared to~     placebo was investigated in women with moderate to severe vasomotor symptoms associated with~     the menopause. The primary study hypothesis was that esmirtazapine would show superior~     efficacy to placebo.~   "
228905|NCT00560820|"~     The primary purpose of this study is to evaluate the effect of deferasirox on renal~     hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and~     filtration fraction (FF).~   "
228906|NCT00560807|"~     This study will determine biological responses to different dosages of neck mobilization~     intervention in patients, providing opportunities to identify the optimal dosage, predictors~     of response, outcome measures as well as the longitudinal changes in biology.~      Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of~     less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive~     different doses of mobilization. The dosage treatment groups will differ in the number of~     sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment~     intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure~     that the impact of any mobilization is included and because previous studies suggest a single~     mobilization may have a treatment effect.~      All patient participants will receive a core standard treatment of education, advice to stay~     active, and neck/postural stretching and strengthening exercise. All patient participants~     will receive supervised exercise and advice for the full 12 weeks. All patients will be~     provided with an instructional CD and exercise brochure to reinforce the whole program.~      Follow-up assessments will consist of quantitative sensory testing (vibration threshold;~     current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp~     Task, muscle biology analyses (cytokine analyses), central breathing control tests~     (capnography), range of motion, head flexion endurance, and self-report symptoms and~     disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder,~     Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36).~      Hypothesis: During recovery, patient are expected to transition from an acute painful state~     to one where they can resume normal activity and add intensive strengthening exercises.~   "
228907|NCT00560794|"~     The purpose of this study is to determine whether the bispecific T-cell engager (BiTE®)~     Blinatumomab (MT103) is effective in the treatment of ALL patients with minimal residual~     disease.~   "
228908|NCT00560781|"~     This study will test the therapeutic potential of augmenting a stable SSRI regimen with the~     neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients~     diagnosed with PTSD.~   "
228909|NCT00560768|"~     The aim of the study is to assess the negative predictive value of the T amplitude variance~     as a method for risk stratification for patients with an increased risk for SCD.~   "
228910|NCT00560755|"~     Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured~     with recombinant human albumin (rHA) when administered to children in their second year of~     life.~      Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured~     with rHA when administered to children in their second year of life.~   "
228911|NCT00560742|"~     The purpose of this study is to determine whether the administration of patient's own bone~     marrow cells into scar areas of the heart, can improve the contractile function of these~     areas.~   "
228915|NCT00560690|"~     Insulin resistance is known to adversely effect viral response to treatment in hepatitis C~     patients~      We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of~     hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized~     controlled trial~   "
228916|NCT00560677|"~     We propose to establish a database characterizing the presence or absence of comorbid PTSD in~     veterans with schizophrenia or schizoaffective disorder (SAD) receiving services at the~     Durham VA Medical Center. In addition to the evaluation of PTSD symptoms in veterans with~     schizophrenia or SAD, this database will facilitate the investigation of a number of~     additional specific research questions relevant to veterans with psychotic disorders.~   "
228917|NCT00560664|"~     Numerous surgical techniques have been developped for the treatment of chondral and~     osteochondral defects of the knee. Among those techniques autologous chondrocyte~     transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF~     is available. The aim of this randomized trial is to compared this new ACT technique to~     mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring~     system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64~     patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at~     a 5% alpha level. Twelve surgical centers in France are involved.~   "
228918|NCT00560651|"~     Corneal Cross Linking is new treatment modality for patients with keratoconus. A keratoconus~     is characterized by progressive bulging and thinning of the eye's cornea. Keratoconus is a~     potentially severely sight impairing condition that may necessitate corneal transplantation~     in the progressive state.~      Corneal Cross Linking is designed to~        -  increase the cornea's mechanical stability~        -  to stop progression of bulging and thinning of the cornea~        -  to prevent the need for corneal transplantation~      Corneal Cross Linking is performed by~        1. Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea~        2. Illuminating the cornea with UV-light~      This register of Corneal Cross Linking procedures performed in Germany serves to~        -  gather long-term results~        -  detect rare complications and side-effects~        -  evaluate the efficacy in a large number of patients~   "
228919|NCT00560638|"~     This was a single-center, randomized, double-masked, placebo-controlled, parallel-group,~     4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects~     were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo~     (vehicle of loteprednol etabonate ophthalmic suspension, 0.5%) and instructed to dose~     bilaterally either TID or QID according to randomization.~   "
228920|NCT00560625|"~     Inhaled corticosteroids are largely used in patients with asthma or chronic obstructive lung~     diseases. The purpose of this study is to determine if the use of inhaled corticosteroids is~     associated with suppression of endogenous cortisol production, as seen in patients treated~     with pharmacologic doses of oral or parenteral steroids.~   "
228921|NCT00560612|"~     The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine~     for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the~     early post-deployment period; and 2) To determine the potential efficacy of paroxetine in~     preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and~     improving overall veteran function.~   "
228922|NCT00560599|"~     This clinical trial tests the hypotheses that 1) body decolonization of patients with~     recurrent community-associated (CA) MRSA infections and their household members and 2)~     environmental decolonization of the patients' households will significantly reduce the~     likelihood of recurrent CA-MRSA infection.~   "
228923|NCT00560586|"~     -Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in~     children with mild obstructive sleep apnea with and without allergic rhinitis that would not~     be treated with T&A. The aim of the study is to conduct a randomized double blind cross-over~     trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in~     children with mild sleep apnea that would not be candidates for T&A.~   "
228924|NCT00560573|"~     CP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1~     Receptor (IGF-1R). Preclinical and clinical data indicate that CP 751,871 augments the~     anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of~     CP 751,871 (or the Maximal Feasible Dose) in combination with standard gemcitabine-cisplatin~     chemotherapy for the treatment of advanced Non-Small Cell Lung cancer.~   "
228925|NCT00560560|"~     This study will test if there is any survival benefit in patients with refractory metastatic~     colorectal cancer that receive CP-751, 871.~   "
228926|NCT00560547|"~     This single arm study will assess the long-term maintenance of hemoglobin levels, safety and~     tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients~     with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa~     maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360~     micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be~     adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
228927|NCT00560534|"~     To investigate the diagnostic performance of whole body magnetic resonance angiography~     (WB-MRA) using subsystolic venous compression of the thigh.~   "
228928|NCT00560521|"~     Tuberculosis (TB) remains as an important public health problem worldwide. Pleural~     tuberculosis is the most prevalent form of extrapulmonary presentation in immunocompetent~     patients.~      The volume of effusion in the pleural space of patients with pleural TB may cause~     complications like restrictive ventilator lung functional disturb and/or pleural thickening.~     The respiratory physiotherapy can be adjuvant on treatment of pleural effusion tuberculosis~     throughout of various treatment technique.~      The Continuous positive airway pressure (CPAP) is utilized in various pathologic, this~     improves lung mechanics by recruiting atelectatic alveoli, improving pulmonary compliance,~     and reducing the work of breathing.~      The aim of this study is to determine the effect of CPAP on fluid absorption among patients~     with pleural effusion due tuberculosis.~   "
229187|NCT00556972|"~     The purpose of this feasibility study is to evaluate the performance and skin-friendliness of~     the barrier of the Fecal Incontinence Management System. The investigator will complete a~     questionnaire for each of the tested products and the products will be evaluated as regards~     leakage, wear time, and skin-friendliness.~   "
228929|NCT00560508|"~     The objective of this trial is to investigate the safety, tolerability, trough plasma~     concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR~     administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the~     double-blind period). The double-blind period will be followed by the open-label 52 week~     administration of pramipexole ER to evaluate the long term safety and efficacy (the~     open-label period).~   "
228930|NCT00560495|"~     RATIONALE: Ammonium tetrathiomolybdate may stop the growth of non-small cell lung cancer by~     blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor~     cells. Giving ammonium tetrathiomolybdate together with radiation therapy may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects of giving radiation therapy together~     with ammonium tetrathiomolybdate in treating patients with stage I, stage II, or stage III~     non-small cell lung cancer.~   "
228931|NCT00560482|"~     To investigate ABR-215050 as a possible treatment for prostate cancer.~   "
228932|NCT00560469|"~     Obesity is a strong risk factor for developing type 2 diabetes (T2DM), but the reasons for~     this are not fully understood. In particular, it is not known why some obese people develop~     T2DM while other obese individuals do not. This study tests whether differences in fat cells~     (adipocytes) are to blame. Even in adults, fat cells are constantly being formed to replace~     old fat cells and to respond to the body's need to store excess energy. The ability to form~     new fat cells may be diminished in some individuals, leading to larger fat cells. These large~     fat cells secrete hormones that may increase risk for T2DM. This study tests whether fat~     cells from obese insulin resistant subjects (who are at risk for developing T2DM) form at a~     slower rate than those from insulin sensitive subjects (who are at lower risk for developing~     T2DM).~      To address this question we will recruit and study two groups of obese subjects, selected to~     be similar in age, gender and degree of obesity. One group of subjects will be obese and~     insulin resistant (the OIR group), while the other will be comparably obese, but insulin~     sensitive (OIS). Subjects will undergo a series of studies to characterize their metabolism~     including measurement of body fat by DEXA scanning, oral glucose tolerance (a test used to~     diagnose diabetes) and measurement of insulin sensitivity in response to an infusion of~     insulin (a research study used to classify patients into the OIR and OIS groups). Small~     samples of fat (from just under the skin of the belly and the buttocks) will obtained using a~     needle on two occasions over 12 weeks. During these 12 weeks, subjects will drink a small~     amount of water that contains a non-radioactive label. This labeled water will allow us to~     measure the rate of growth of new fat cells in the body. We will also look at the rate of~     growth of fat cells obtained from these biopsies in the laboratory.~      The results of this study may tell us more about why certain obese people develop diabetes~     and why others do not. This might lead to new ways to prevent or treat T2DM.~   "
228933|NCT00560456|"~     Young subjects and patients with nocturnal respiratory disorders are frequently involved in~     sleep-related accidents. This study assess the impact of chronic sleep restriction (4 hr of~     sleep during 5 days) or total sleep deprivation in young or mature healthy subjects or~     snorers on simulated driving, objective and subjective sleepiness and objective and~     subjective cognitive performances. The effects of recovery night on these parameters are also~     assessed.~   "
228934|NCT00560443|"~     Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic~     regimes per os on pain due to not compound bone fractures in child 4-17 years old:~        -  ketorolac 0,5 mg/kg (1 drop every 2 Kg)~        -  tramadol 2,5 mg/Kh (1 drop every 2 Kg)~      Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every~     20 min.~      The main objectives are the evaluation of pain decreasing in every group, the time of~     decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side~     effects Secondary outcomes are comparison between the two groups on effectiveness on pain and~     on side effects~   "
228935|NCT00560430|"~     A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors~     and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type~     2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. The~     investigators therefore will investigate the effect of telmisartan, a potent ARB, on lipid~     metabolism, glucose metabolism and inflammation in patients with the metabolic syndrome.~     Specific parameters will be tested before treatment and after 3 months of treatment. Placebo~     will be compared to 2 different doses of telmisartan per day.~   "
228936|NCT00560417|"~     This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in~     combination with the patient's oral diabetes medications and exenatide, for their ability to~     control blood sugar in patients with type 2 diabetes.~   "
228937|NCT00560404|"~     This 2 arm study will compare the efficacy and safety of monthly administration of~     subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis~     patients with chronic renal anemia. Patients currently receiving maintenance treatment with~     epoetin alfa will be randomized to receive either monthly injections of Mircera with a~     starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were~     receiving in the week preceding study start, or to continue on epoetin alfa treatment. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
228938|NCT00560391|"~     The purpose of this study was to determine the safety and tolerability of dasatinib when~     given in combination with lenalidomide and a low dose dexamethasone for the treatment of~     relapsed or refractory multiple myeloma.~   "
228939|NCT00560378|"~     Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema~     are entitled to enter this four-year follow study to investigate the safety of treatment with~     Tacrolimus ointment 0.1%~   "
228940|NCT00560365|"~     RATIONALE: Following patients who have undergone surgery for colorectal cancer may help~     doctors learn more about the disease and plan better follow-up care.~      PURPOSE: This randomized clinical trial is following patients who have undergone surgery for~     stage I, stage II, or stage III colorectal cancer.~   "
228941|NCT00560352|"~     The purpose of this study is to determine the safety and tolerability of dasatinib with~     bortezomib in the treatment of relapsed or refractory multiple myeloma.~   "
228942|NCT00560339|"~     The purpose of this study is to determine whether there is a relationship between serial~     B-natriuretic peptide (BNP) and implantable device measured intrathoracic impedance in~     symptomatic and asymptomatic heart failure patients over a 1-year period. Furthermore, this~     study will establish whether implantable device measured intrathoracic impedance trends with~     the distance walked on a six-minute hall walk (6MHW), an exercise-based acute measure that~     has also been associated with heart failure clinical status.~   "
228943|NCT00560326|"~     The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment~     as long-term treatment in paediatric patients with atopic dermatitis.~   "
228944|NCT00560313|"~     This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of~     Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to~     healthy at-risk adults.~   "
228946|NCT00560287|"~     Non-invasive mechanical ventilation (NIV) has been increasingly used as a treatment of~     chronic hypercapnic respiratory failure. Its use in patients affected by chronic obstructive~     pulmonary disorders is still controversial, while most of the studies performed in~     restrictive thoracic disorders (RTD), and in particular in neuromuscular patients, suggested~     alleviation of the symptoms of chronic hypoventilation in the short term, and in two small~     studies survival was prolonged.~      In the terminal phase of the disease, when the respiratory muscles became weaker it is very~     likely that the operators need to frequently adjust the level of inspiratory pressure in an~     attempt to guarantee an adequate tidal volume, so that alveolar hypoventilation may be~     avoided.~      Theoretically the use of a volume assisted ventilation may overpass this problem of frequent~     variations of the settings, since the provision of a fixed tidal volume may always guarantee~     and adequate alveolar ventilation.~      The primary aims of this multicenter randomized study are to evaluate the clinical efficacy,~     the patients' tolerance and quality of life and the frequency of changing settings in a group~     of patients with SLS and initial chronic respiratory failure undergoing long-term NIV with~     Pressure Support Ventilation or Volume Assisted Ventilation.~   "
228947|NCT00560274|"~     This single arm study will assess the safety of NeoRecormon in the correction of anemia in~     patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin~     combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c.~     which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time~     on study treatment is 1 year, and the target sample size is 100-500 individuals.~   "
228948|NCT00560261|"~     Sickle cell disease (SCD) is the most common inherited disease of the world affecting African~     and Caribbean populations. SCD is caused by the homozygous inheritance of the gene for sickle~     hemoglobin (HbS). Most patients with SCD develop abnormal pulmonary function characterized by~     airway obstruction, restrictive lung disease, abnormal diffusing capacity, hypoxemia and~     pulmonary hypertension In healthy subjects, lung capillary blood volume (Qc) and membrane~     diffusing capacity (Dm) can be accurately measured by the nitric oxide-carbon monoxide~     (NO-CO) method. We propose to study, for the first time, lung capillary blood volume and~     alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at~     least 6 years Early determination of lung function and pulmonary circulation in children with~     SCD is very important, not only for the understanding of physiopathologic mechanisms of the~     disease but also for a better therapeutic management of these children.~   "
228949|NCT00560248|"~     The purpose of this registry is to assess and improve the process of care and health outcomes~     of patients presenting to the Emergency Department with chest pain suspected to be of cardiac~     origin. The study will identify which methods facilitate the diagnosis and risk~     stratification of ST elevation myocardial infarction (STEMI) or non STEMI, including patients~     with occult myocardial infarction (MI), and result in a shorter time to definitive diagnosis~     and treatment.~   "
228950|NCT00560235|"~     Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors~   "
228951|NCT00560222|"~     Much has been learned in recent years about the mechanisms by which breastfeeding improves~     child health and survival. However, there has been little progress in using these insights to~     improve pediatric care. Factors that are important for protecting the breast fed infant might~     be expected to decrease the adverse effects of weaning on diarrhea, growth, and development.~     The proposed study is meant to begin addressing this important gap by a clinical trial of~     lactoferrin supplementation in previously weaned children. Lactoferrin,an iron-binding~     protein with multiple physiological functions (anti-microbial, anti-inflammatory, and~     immunomodulatory), is one of the most important proteins present in mammalian milk. Our~     hypothesis is that lactoferrin (given as a daily supplement in amounts similar to those~     consumed if the child were still breastfed) will improve health by mimicking its protective~     roles in milk. The significance of these studies is that they will prove feasibility of~     improving child health after the end of breastfeeding by continuing ingestion of a major~     protective milk protein. Diarrhea and malnutrition after weaning is a global problem that may~     be amenable to this approach.~   "
228952|NCT00560209|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients~     scheduled for coronary angiography, in a double-blind, randomized, placebo-controlled,~     parallel group, multi-center study.~   "
228953|NCT00560196|"~     The purpose of the study is to investigate pain, anxiety and depression in patients with~     panic anxiety disorders without pain or depression without pain compared with healthy~     volunteers~   "
228954|NCT00560183|"~     This study will explore the efficacy and safety of a fixed dose combination of morphine and~     oxycodone for management of acute postoperative pain. The study will explore the efficacy~     dose response and dosing interval required to maintain adequate analgesia at each tested~     dosage strength.~   "
228955|NCT00560170|"~     Multiple clinical trials, using 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase~     inhibitors (statins), have shown benefit in the primary and secondary prevention of~     atherosclerotic complications. However, till now, there is an incomplete understanding of all~     the mechanisms of the biologic effects of statins beyond LDL cholesterol (LDL-C) reduction,~     but there is accumulating evidence that the Rho-GTP/Rho-Kinase pathway (Rho/Rho-K) plays an~     important role and may be a strategic therapeutic target in cardiovascular diseases. With~     similar LDL-C reduction ability, the availability of Ezetimibe offers the potential to begin~     to address the question whether some of the benefits conferred by statins may accrue~     independently of their effects on LDL-C lowering. A better understanding of the role of the~     Rho/Rho-kinase signaling pathway in the pathogenesis of atherosclerosis in human is~     essential. Inhibition of Rho/Rho-kinase by statins may explain some of the biological~     beneficial effects of statins observed in clinical trials. This study aims to translate into~     patients important experimental discoveries regarding the initiation of inflammation in~     atherosclerosis in an attempt to improve upon the present treatment of cardiovascular~     diseases.~   "
228956|NCT00560157|"~     Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with~     those of a standard polymeric one, in ICU patients~   "
229188|NCT00556959|"~     The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release)~     is a safe and effective treatment for children and adolescents with attention deficit~     hyperactivity disorder (ADHD).~   "
228957|NCT00560144|"~     This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in~     children and adolescents with advanced solid tumors equivalent to the exposure achieved in~     adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated~     dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be~     sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to~     exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of~     patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is~     until disease progression or dose limiting toxicity, and the target sample size is <100~     individuals.~   "
228958|NCT00560131|"~     To evaluate the autonomic cardiac function in patients with complex regional pain syndrome~   "
228959|NCT00560118|"~     RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors~     predict how well patients will respond to treatment.~      PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating~     patients with metastatic melanoma.~   "
228960|NCT00560105|"~     This is an eight-week, randomized, controlled, two arm parallel study. The study consists of,~     a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0,~     1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to~     confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum~     samples will be collected and weighed at each clinic visit. In addition to clinic visits,~     subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation~     will include adverse event surveillance, and St. Georges Respiratory questionnaire.~   "
228961|NCT00560092|"~     Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the~     central nervous system [1]. Magnesium deficiency is associated to an increased activation of~     these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site~     of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium~     may have anti-hyperalgesic effect when administered intrathecally [2]. As intrathecal~     magnesium has already been used in humans for treatment of eclampsia, we stated that it could~     also improve postoperative analgesia and reduce the need for auto-administered morphine if~     given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and~     sufentanil) injected for orthopedic surgery.~   "
228962|NCT00560079|"~     This study aims to evaluate the potential antimanic efficacy, safety and tolorability of the~     purinergic agents allopurinol and dipyridamole as an add-on treatment to lithium in a sample~     of 180 drug-free manic patients enrolled in a double-blind, placebo-controlled design.~   "
228963|NCT00560066|"~     Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian~     Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and~     without underlying medical conditions and evaluation of the immunogenicity in a subset of~     subjects with underlying medical conditions, compared to an egg-based vaccine in a post~     marketing setting.~   "
228964|NCT00560053|"~     The study objectives are to investigate the toxicity and the BUMEL response rate; in patients~     who reach the CR after autotransplantation, investigate if negativization of IF, influences~     in disease evolution; in patients in PR after autotransplantation, analyze if the second~     intensive procedure is capable of increasing the response rate and increasing the survival so~     that patients who reached the CR with the first transplantation; Patients with MM primarily~     resistant to the chemotherapy, investigate the efficacy of a double transplantation; patients~     submitted to double transplantation, control the efficacy of the second transplantation in~     front of allogenic transplantation.~   "
228965|NCT00560040|"~     To determine if pre-race training effects heart damage induced by marathon running.~   "
228966|NCT00560027|"~     The objective of the study was to assess the prevalence, timing, and co-occurrence of~     positive screens for maternal postpartum depression (PPD) and intimate partner violence (IPV)~     for women bringing their young infants for pediatric primary care and examine relationships~     between PPD, IPV and children's healthcare utilization from birth to 2 years.~   "
228967|NCT00560014|"~     The purpose of this study is to look at lipid profiles of plasma and RBC and amino acid~     profiles in plasma to determine if they are associated with allograft rejection, calcineurin~     inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving~     dietary supplements with arginine and omega-3 fatty acids.~   "
228968|NCT00560001|"~     The objective of this study is to quantify the benefits of using the MD.2 on health outcomes.~   "
228969|NCT00559988|"~     The IMPACT Study will investigate the potential clinical benefit of the combined use of~     BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to~     conventional device evaluation and physician-directed anticoagulation in patients with~     implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.~   "
228970|NCT00559975|"~     To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with~     CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in~     healthy adults. Safety will be assessed by observation of symptoms, physical examination~     findings and laboratory safety testing.~   "
228971|NCT00559962|"~     To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin,~     ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic~     Resonance Spectroscopy~   "
228972|NCT00559949|"~     This phase II trial is studying how well selumetinib works in treating patients with~     papillary thyroid cancer that did not respond to radioactive iodine. Selumetinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
228973|NCT00559936|"~     The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab~     (Avastin) for treatment of corneal neovascularization.~   "
228974|NCT00559910|"~     PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is~     associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential~     safety and efficacy profile in COPD.~   "
229214|NCT00556569|"~     The purpose of this study is to determine if the Moving Smart program, a daily 10-minute~     classroom-based exercise program, increases physical activity levels during the school day in~     Bronx elementary school students.~   "
228975|NCT00559897|"~     RATIONALE: A positron emission tomography scan is a procedure in which a small amount of~     radioactive sugar is injected into a vein, and a scanner is used to make detailed,~     computerized pictures of areas inside the body where tumor cells are found. This study is~     looking at whether the drug zoledronic acid interferes with the ability of a PET scan to find~     tumor cells.~      PURPOSE: This phase II trial is studying how well positron emission tomography works when~     given together with zoledronic acid in finding tumor cells in patients with advanced~     non-small cell lung cancer.~   "
228976|NCT00559884|"~     The purpose of this research study is to look at concentrations of GSK189075 in blood when~     different long and short acting forms of the drug are taken by mouth. The results will help~     to decide whether a long-acting form of GSK189075 can be made. The effects of the drug on the~     body and safety will also be studied.~   "
228977|NCT00559871|"~     The purpose of this study is to determine whether Fipamezole is effective in the treatment of~     levodopa-induced dyskinesia in advanced Parkinson's disease.~   "
228978|NCT00559858|"~     RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by~     chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in~     preventing hand-foot syndrome.~      PURPOSE: This phase III randomized trial is studying pyridoxine to see how well it works~     compared to a placebo in preventing hand-foot syndrome in patients who are receiving~     capecitabine for advanced colorectal cancer or breast cancer.~   "
228979|NCT00559845|"~     This single arm study will assess the efficacy and safety of sequential neoadjuvant~     chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants~     with inflammatory or locally advanced operable breast cancer. Participants will receive~     5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given~     concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and~     the target sample size is <100 individuals.~   "
228980|NCT00559832|"~     Acclimatization by mountaineering prior to high altitude sojourns have shown to be effective~     in prevention of acute mountain sickness (AMS).~      The aim of this study is to investigate whether intermittent exposure to normobaric hypoxia~     during sleep is also effective to prevent AMS.~   "
228981|NCT00559819|"~     The proposed study will validate and determine sensitivity of our new driving simulator,~     created to evaluate driving ability in a related study to show similar driving performance~     between patients on chronic opioid treatment and a control group. Although the commercial~     version of the simulator has been validated for certain populations and certain measures,~     these require re-calibration for our own clinical study. The investigators propose a~     prospective randomized clinical trial to evaluate driving skills under alcohol consumption~     using a driving simulator. Two groups of study subjects will be utilized, with the majority~     (80%) receiving alcohol and placebo at different times. A smaller set of study subjects (20%)~     will be given placebo on both trials to evaluate learning effects and placebo blinding~     effectiveness. Each group will take the driving test at three time points: once as a baseline~     at the beginning of the study, once after the 1st dosing of the placebo and again after~     dosing two of the alcohol or placebo beverage. This information will allow us to evaluate~     driving ability under other potentially impairing conditions such as opioid usage.~   "
228982|NCT00559806|"~     The debilitating effects of immobilisation on muscle strength and size in young individuals~     are well documented. Moreover, sarcopenia has long been recognized as a major cause of muscle~     strength loss in old age, however, changes in muscle mass and architecture with~     immobilisation in the elderly has not previously been investigated. This is contrasted by the~     fact that the elderly population more often undergoes periods of immobilization and disuse~     not only due to joint pain but also due to a higher degree of co morbidity and~     hospitalisation.The purpose of the present study was to compare the effect of a 2 week period~     of unilateral immobilisation on the physiological muscle cross sectional area, maximal~     isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation~     angle in young and old healthy men.~   "
228983|NCT00559780|"~     During the last decades there has been an increase in the relative proportion and life~     expectancy of elderly people in the industrialised countries. Consequently the amount of~     elderly with diseases and disabilities related to aging has increased. It therefore appears~     paramount to gain a better understanding of how disuse and immobilisation affects~     neuromuscular properties in the elderly, as well as to identify training regimes that ensures~     an effective rehabilitation.The population of interest in the present study was elderly~     individuals with long term hip-osteoarthritis undergoing a hip-replacement operation. The~     study was divided in two parts, a cross-sectional study and an intervention study.~      The cross-sectional study investigated muscle size, maximal muscle strength, specific force,~     neural drive and explosive muscle force characteristics in elderly individuals who were~     affected by unilateral prolonged disuse due to hip-osteoarthritis. The data clearly indicated~     that the side with hip-osteoarthritis was affected by a marked decrease in muscle mass,~     maximal muscle strength, neural drive and explosive muscle force characteristics compared to~     the unaffected side.~      The intervention study investigated if elderly patients that undergo hip-replacement surgery~     could benefit from additional training in the early postoperative phase. The data clearly~     demonstrated that resistance training was an effective and safe way to increase muscle mass,~     maximal muscle strength, neuromuscular activity, functional performance and decrease the~     hospitalisation period compared to regimes of conventional rehabilitation regimen or~     electrical muscle stimulation. Additionally the intervention study demonstrated that~     resistance training effectively induced marked increases in explosive muscle force~     characteristics in elderly subjects compared to rehabilitation regimes using electrical~     muscle stimulation or conventional rehabilitation. Furthermore, the gains in maximal muscle~     strength and explosive muscle force characteristics were accompanied by significant increases~     in EMG amplitudes. Furthermore, the demonstration that explosive muscle force capacity of the~     neuromuscular system remains trainable in elderly recovering from prolonged limb disuse and~     major surgery may have important implications for future rehabilitation programs, especially~     when considering the importance of rapid muscle force capacity on postural balance, maximal~     walking speed and other tasks of daily life actions.~   "
228994|NCT00559637|"~     This single arm study will assess the efficacy and safety of subcutaneous Mircera for~     correction of anemia in participants with chronic kidney disease who are not treated with~     erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will~     receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight,~     will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11~     months, and the target sample size is 100-500 individuals.~   "
228995|NCT00559624|"~     The main aim of this study is to test the safety of acadesine in patients with B-CLL and see~     what effects it has on patients and their leukaemia. The study also aims to examine the way~     acadesine is processed by the body. The study will look at the effects of acadesine in the~     body and the concentration of the drug and its main by-product (ZMP) in the blood to~     determine the dose and the frequency of dosing that is likely to be the most effective.~   "
229056|NCT00558805|"~     This project evaluates a brief intervention in the emergency department (ED) for adolescents~     presenting with suicide attempts. The intervention aims to capitalize on the opportunity~     offered by the ED visit to deliver an effective intervention, improve adherence to follow-up~     care, decrease the risk of repeat suicide attempts, and improve clinical and functioning~     outcomes.~   "
228984|NCT00559767|"~     This study will identify which regions on the genes, and genes themselves, may account for an~     increased risk of end stage renal disease (ESRD), that is, near-total loss of kidney~     function, for people of African American descent. Researchers will use a technique called~     admixture linkage disequilibrium (MALD) to study genomes, genetic material, in about 2,500~     participants from two existing studies and participants who will serve as controls. ESRD~     disproportionately affects African Americans, who constitute 29% of all ESRD patients in the~     Medicare ESRD program. The disease can result from a variety of diseases, with diabetes as~     the leading underlying cause (44% of cases) and hypertension as the second leading cause~     (26%). The proportion of ESRD cases caused by diabetes has increased dramatically.~      Patients age 18 and older who are African American, who have ESRD, and who are participants~     of the FIND and CHOICE studies may be eligible for this study. FIND, or Family Investigation~     of Diabetes and Nephropathy, involves a multicenter study to identify susceptibility genes,~     that is, those with a risk, for diabetic and other forms of kidney disease. CHOICE, or~     Choices for Healthy Outcomes in Caring for ESRD patients is an ongoing study that identifies~     risk factors for cardiovascular outcomes in ESRD patients. The principle of mapping by MALD~     involves genetic variations that exist across populations. When mixing occurs between~     populations having different (heterogeneous) genes, the admixed offspring inherits~     chromosomes of distinct ancestry. However, over generations of mating, and recombination over~     several generations, originally large blocks of DNA from African ancestry have become part of~     smaller segments throughout the chromosome. The study will focus on risk alleles, that is,~     alternative forms of genes that carry a disease risk. Risk alleles are closely related to~     nearby ancestral gene markers found in a person.~      Patients will undergo a collection of blood and urine for genetic testing. Researchers are~     conducting separate analyses in this study. Case-control analysis of ESRD will consist of~     1,150 participants from FIND and 250 from CHOICE. There will also be 750 control participants~     from FIND. For the case-control analysis of diabetic ESRD, there will be about 750~     participants from FIND, 125 from CHOICE, and 750 controls from FIND. Finally, there is the~     quantitative trait analysis, which looks at the phenotype-meaning visible characteristics~     produced by the interaction of a person's genetic makeup with the environment. That analysis~     will involve 350 patients with diabetic nephropathy but not ESRD and 750 controls from FIND.~   "
228985|NCT00559754|"~     This single arm study will assess the efficacy and safety of a combination of Avastin and~     docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable~     breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin~     (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each~     cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each~     cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). The anticipated time on~     study treatment is 3-12 months, and the target sample size is <100 individuals.~   "
228986|NCT00559741|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving cetuximab~     together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination~     chemotherapy works in treating patients with advanced or metastatic colorectal cancer.~   "
228987|NCT00559728|"~     The purpose of this study is to analyze atherosclerotic vessel wall components with~     multidetector computed tomography (MDCT) and compare with MRI. The hypothesis is that MRI is~     comparable to computed tomography (CT) in showing plaque components of coronary plaques.~   "
228988|NCT00559715|"~     The study is designed to demonstrate the therapeutic non-inferiority of the recombinant~     humanized monoclonal VEGF antibody bevacizumab administered by intravitreal injection in the~     treatment of AMD in comparison to the related fragment ranibizumab.~   "
228989|NCT00559702|"~     The primary objective of this study is to compare the pharmacokinetic (PK) and~     pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg~     natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis~     (MS) participants. The secondary objectives are to investigate the safety, tolerability and~     PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of~     repeated natalizumab doses administered SC and IM, to explore proof of concept within the~     secondary progressive multiple sclerosis (SPMS) population using change from baseline in~     clinical measures including: expanded disability status scale (EDSS), multiple sclerosis~     functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale~     (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures~     including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1~     hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy,~     magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the~     effect of natalizumab administered IV and SC on brain MRI measures in participants with~     relapsing forms of MS.~   "
228990|NCT00559689|"~     Once-daily inhaled glucocorticosteroids treatment can sufficiently control airway~     inflammation in asthma patients.~   "
228991|NCT00559676|"~     RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with~     cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on~     biomarkers. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This phase IV trial is studying biomarkers in patients undergoing chemotherapy for~     metastatic colorectal cancer.~   "
228992|NCT00559663|"~     The purpose of this study is to compare the effect of dark chocolate with green tea in~     healthy subjects on clot formation (platelet activity) cholesterol profile and markers of~     inflammation in two groups.~      The first group will be on a regimen of dark chocolate, and the second group will be on a~     regimen of green tea. Clinical outcomes will be determined after seven days of each treatment~     and both groups will undergo both treatments subsequently and serve as their own control.~      The hypothesis is that both green tea and dark chocolate will reduce platelet activity and~     reduce LDL, hsCRP and increase HDL.~   "
228993|NCT00559650|"~     The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667)~     given intravenously, to evaluate if this is safe and can help to improve the well-being,~     symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with~     chronic heart failure have a risk of increased number of hospitalisations because of~     worsening of their condition (decompensated heart failure). The current treatment of acute~     heart failure consists of oxygen and medical treatment with vasodilators and positive~     inotropic agents (drugs, which should strengthen the pump function of the heart) which have~     their limitations. Therefore there is a need for new drugs in treatment of acute heat~     failure.~   "
229057|NCT00558792|"~     Determine the validity and compare the visualization of arterial segments obtained with 3~     doses of iopamidol to determine dose for further investigation in future trials.~   "
229058|NCT00558779|"~     The purpose of the study is to compare two surgical strategies for coronary artery bypass~     grafting with respect to the occurrence of cerebral infarctions made visible by magnetic~     resonance imaging~   "
228996|NCT00559611|"~     The goal of this clinical research study is to compare 2 different methods for checking lymph~     glands (in the middle of the chest) for cancer cells.~      Objectives:~      The aim of this prospective study is to determine the staging accuracy of endobronchial~     ultrasound guided fine needle aspiration biopsy of mediastinal lymph nodes compared to the~     'gold standard', mediastinoscopy, in patients with clinical Stage IIIA non-small cell lung~     cancer.~      Primary Objective:~      To determine the sensitivity, specificity, positive predictive value, negative predictive~     value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal~     metastases.~      Secondary Objectives:~      To estimate quantitative and qualitative differences regarding sampling of mediastinal nodes~     (number and location of nodes biopsied, number and location of positive nodes, extracapsular~     extension, ability to biopsy contralateral nodes).~      To determine the frequency of change of planned therapeutic management resulting from outcome~     of EBUS-FNA and mediastinoscopy.~      To determine procedure related complications. To perform analysis of cost between EBUS-FNA~     and mediastinoscopy.~   "
228997|NCT00559598|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer and from~     healthy participants may help doctors identify and learn more about proteins related to~     cancer. It may also help doctors tell whether a patient has cancer.~      PURPOSE: This clinical trial is looking at proteins in blood samples to see how well they~     work in finding pancreatic cancer and extrahepatic biliary tract cancer.~   "
228998|NCT00559585|"~     The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept~     yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in~     participants with rheumatoid arthritis and an inadequate response to current methotrexate~     therapy.~   "
228999|NCT00559572|"~     This study will evaluate the impact of motivational guidance to exercise on people with~     schizophrenia, based on their participation in a walking program.~   "
229000|NCT00559559|"~     This study is intended to look at the effect of the SJM vibrating Patient Notifier™ system,~     which will warn the patient of possible failures of the implanted system, on reducing patient~     device related anxiety~   "
229001|NCT00559546|"~     The purpose of the study is to find out if montelukast can be used to treat the various~     symptoms of allergic syndrome.~   "
229002|NCT00559533|"~     This study will determine the maximum tolerated dose and the optimal associated 4 weekly~     dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid~     tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily~     for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose~     escalations, and possible changes in dosing schedule, based on tolerability and~     pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study~     treatment is until disease progression or intolerable toxicity.~   "
229003|NCT00559520|"~     The role of preoperative oral immunonutrition in major vascular surgery.~      The mean purpose of this study was to determine the prevalence of post-operative infection~     complications after major vascular surgery in group of patients with preoperative oral~     immunonutrition.~      This group was compared to a control group.~      Secondary purpose was to evaluate the effect of preoperative oral immunonutrition on~     postoperative mortality (30 days), the medium length of stay in the hospital and the cost of~     treatment in the two groups~   "
229004|NCT00559507|"~     This phase II trial is studying saracatinib to see how well it works in treating patients~     with metastatic or locally advanced breast cancer that cannot be removed by surgery.~     Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth~   "
229005|NCT00559494|"~     While research in animal models of spinal cord injury have provided many promising insights,~     human studies have failed to produce effective therapies. We propose to investigate the drug~     Minocycline (a metalloproteinase inhibitor) for the treatment of spinal cord injured patients~     aiming to limit neurological injury and improve neurological outcome. This drug influences~     several secondary injury mechanisms implicated in spinal cord injury and has been effective~     in improving outcome after spinal cord injury in animal models. We also propose to examine~     the safety and feasibility of spinal cord perfusion pressure augmentation with a protocol of~     IV fluids and inotrope medications versus standard maintenance of mean arterial pressure in~     subjects who exhibit a decrease in perfusion pressure to less than 75 mmHg. The purpose of~     this pilot study is 1) to evaluate the feasibility of a clinical trial protocol for~     Minocycline in patients with acute spinal cord injury, and 2) to ensure adequate drug dosing~     and metabolic effect. After undergoing a process of informed consent, patients agreeing to~     participate in the study will be randomized to placebo or treatment groups in a double-blind~     fashion. Clinical neurological examinations, patient-reported quality of life, and functional~     independence categorization will be combined with serum and cerebrospinal fluid laboratory~     investigations to establish some of the pharmacological properties and the safety profile of~     this medication in this group of patients. In addition, patient tolerance to the dosing~     regimen will be assessed. The results of this study will provide the preliminary data~     necessary to plan for a larger prospective, randomized, controlled, double-blind clinical~     trial to assess efficacy and to further assess safety.~   "
229006|NCT00559481|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving~     ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more about~     how these drugs are used by the body.~      PURPOSE: This randomized clinical trial is studying how ketoconazole, dexamethasone, and~     hydrocortisone act in the body of patients with prostate cancer that did not respond to~     androgen-deprivation therapy.~   "
229007|NCT00559468|"~     The objective of the trial was to show equivalence in recovery from neuromuscular block after~     a single dose of 4.0 mg.kg-1 Org 25969, administered at T1 3-10% after continuous infusion of~     rocuronium, between subjects receiving maintenance anesthesia using propofol and subjects~     receiving sevoflurane, to investigate the safety and to compare the plasma levels of~     rocuronium in subjects after continuous infusion of rocuronium and before the administration~     of Org 25969, under either propofol or sevoflurane anesthesia.~   "
229008|NCT00559455|"~     Primary objective:~      To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with~     the combination chemotherapy of Eloxatin+5-FU/LV~      Secondary objective:~      To evaluate time to progression, 6month survival, overall survival, safety and tolerability~     of patients with hepatocellular carcinoma treated with the combination chemotherapy of~     Eloxatin+5-FU/LV~   "
229009|NCT00559442|"~     It has been shown, that subjects susceptible to high altitude pulmonary edema (HAPE)are~     characterized by an abnormal increase of pulmonary artery pressure at rest in hypoxia and~     during exercise in normoxia. This abnormal rise of pulmonary artery pressure has also been~     observed in about 10 % of otherwise healthy subjects without prior altitude exposure. The aim~     of the study is to investigate the susceptibility to HAPE in unacclimatized subjects with~     abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in~     normoxia after rapid ascent to high altitude (4559 m).~   "
229010|NCT00559429|"~     The primary objective of the study is to determine a recommended phase II dose (RP2D).~      The secondary objective of the study are:~        1. To evaluate preliminary incidence and duration of clinical benefits as determined by~          improvements of pain, PSA decline and bone scan changes.~        2. To evaluate the toxicity profile of the escalating doses of Docetaxel in combination~          with Samarium 153 in patients with advanced, hormone refractory prostate cancer~          metastatic to the bone.~   "
229011|NCT00559416|"~     Some HIV-infected individuals have a white blood cell marker known as HLA-B*57 that appears~     to help control the progress of the disease; however, not all who have the HLA-B*57 marker~     are able to control the infection. This study will examine the effects of giving white blood~     cells with HLA-B*57 from an individual who controls HIV infection to an individual who cannot~     control HIV infection, as a form of HIV treatment. All candidates will be screened with a~     medical history, physical examination, and blood and urine tests.~      Both donor and recipient volunteers must be HIV-positive individuals 18 years of age or older~     who have the HLA-B*57 marker and are receiving care. Donor candidates must have positive HIV~     antibody tests for at least seven years with a recent CD4 cell count greater than 400~     cells/mm?, HIV viral load less than 50 copies/mL, and no previous HIV viral load greater than~     1,000 copies/mL. Recipient candidates must have positive HIV antibody tests with a recent CD4~     cell count less than 400 cells/mm? and HIV viral load greater than 10,000 copies/mL, and must~     have failed at least two prior combination antiretroviral regimes and are willing to receive~     or resume combination antiretroviral therapy. Donor volunteers will be excluded if they have~     taken certain antiretrovirals drugs, have a medical history of cancer or of other blood-borne~     illnesses, or have other medical conditions that might interfere with the study. Recipient~     volunteers will be excluded if they have a medical history of malignant cancer or other~     medical conditions that might possibly interfere with the study.~      Donors will undergo apheresis to separate white blood cells from circulating blood before the~     red blood cells and plasma are returned to the bloodstream. The procedure will take up to~     five hours, and donors will be required to return for additional tests. Donors may be asked~     to return for further white blood cell donations, a maximum of six procedures per year.~      Recipients will undergo apheresis to obtain stem cells for possible use in the study, and~     will be admitted to an NIH Clinical Center inpatient unit to receive an infusion of white~     blood cells and undergo a series of blood tests both before and after the infusion. The~     infusion process will take two hours. After being discharged, recipients will be asked to~     return to the Clinical Center for monitoring and follow-up tests, and may receive further~     infusions.~   "
229012|NCT00559403|"~     This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual~     behavior of South African adolescents.~   "
229013|NCT00559390|"~     In this study, we want to find out more about polycystic ovary syndrome(PCOS). This is a~     common problem in about 7% of teenage girls. Problems may include irregular periods, extra~     hair on the face, chest and back areas. It seems that PCOS is related to a high level of male~     hormones and to another problem called metabolic syndrome(MBS). People with MBS may have high~     blood pressure, low good cholesterol, high blood fats and extra fat around the waist. Girls~     with MBS are at high risk for getting diabetes and heart disease.~   "
229014|NCT00559377|"~     This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and~     fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment~     for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic~     procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and~     fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will~     respond to treatment.~   "
229015|NCT00559364|"~     This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea~     (malabsorption of dietary fats) in patients with a history of exocrine pancreatic~     insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is~     sponsored by Aptalis Pharma (formerly Axcan).~   "
229016|NCT00559351|"~     The purpose of the study was to test a null hypothesis that a combined modality treatment of~     esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery~     alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant~     treatment of esophageal cancer.~   "
229017|NCT00559338|"~     The purpose of this study is to determine if an 8hr infusion of nesiritide in the emergency~     department in the Acutely decompensated heart failure patients will decrease 30 day~     recidivism.~   "
229018|NCT00559312|"~     Even patients with milder COPD can have significant physiological abnormalities which become~     more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While~     there is a compelling physiological rationale for the efficacy of inhaled~     corticosteroid/long-acting bronchodilator combination therapy [i.e., fluticasone~     250μg/salmeterol 50μg (FSC250/50)] in moderate to severe COPD, little information is~     available on the potential impact of this therapy in milder symptomatic disease. This study~     will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and~     will determine if there is a sound physiological rationale for the use of FSC as therapy for~     this subpopulation.~   "
229019|NCT00559299|"~     The purpose of this study is to determine the safety and tolerability of a new drug,~     GSK163090, which is being developed for the treatment of depression and anxiety disorders.~   "
229020|NCT00559286|"~     The hypothesis of the presented study is: Telmisartan induces an increase of eNOS activity in~     RBC resulting in an enhanced intravascular NO bioavailability, an ameliorated RBC~     deformability and a reduction of RBC and platelet aggregation. This could be a potential~     mechanism of the improvement of microcirculatory disorders, especially in patients with~     diabetes mellitus and arterial hypertension, treated with Telmisartan.~   "
229021|NCT00559273|"~     This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous~     darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who~     are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants~     will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2~     micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45~     mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is~     3-12 months.~   "
229022|NCT00559260|"~     This is a 300 subject prospective study to assess cardiorespiratory events associated with~     current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider~     sedation (150 subjects; propofol) for upper and/or lower endoscopy.~   "
229023|NCT00559247|"~     The primary purpose of this study is to evaluate the safety profile and tolerability of~     single oral doses of BMS-650032 in subjects with chronic hepatitis C infection~   "
229024|NCT00559234|"~     This study will evaluate potential candidates for future clinical research studies related to~     diagnosed or undiagnosed genetic eye disorders or diseases. It will not test any new~     treatments, but it may arrange for standard treatments for existing eye disorders. The~     purpose of the study is to train eye doctors and medical researchers at the National~     Institutes of Health in appropriate methods and procedures for treating patients with genetic~     eye diseases, and to expand the pool of possible participants for future research studies and~     trials on eye health.~      Volunteers for this study may be adults and minor children who have been diagnosed with or~     are at risk for having a genetic eye disease. Candidates may not have any other medical~     conditions that would interfere with the researchers' ability to perform the examinations and~     procedures required for this study.~      Participants will give a complete medical and family history and undergo a series of tests~     and procedures as part of this research study. The procedures include a full eye examination~     and vision testing, electrooculography and an electroretinogram to examine the function of~     the retina, and flourescein angiography to provide information on the flow of blood in the~     participant's eyes. Participants will provide research material for further studies by giving~     a blood sample to be held for genetic testing and analysis, and adult participants will also~     undergo a skin biopsy to provide cell tissue for additional research material. At each clinic~     visit, participants will receive treatment for their genetic eye disease as needed, including~     medications or surgical procedures. Participants may remain a part of this study for up to~     three years.~   "
229025|NCT00559221|"~     - To determine the feasibility of fludarabine and cytarabine as continuous infusion plus~     idarubicin with granulocyte-colony stimulating factor priming for patients with resistant~     acute myeloid leukemia other than acute promyelocytic leukemia~   "
229026|NCT00559208|"~     The purpose of this study is to assess the cost-effectiveness of this Differential Wraparound~     model, in 5 Children's Aid Societies within Hamilton-Niagara Region, in preventing~     maltreatment cases from either becoming ongoing protection cases, or the children ending up~     in out-of-home of out-of community placements, as well as reducing the amount of time in~     Children's Aid Society care as compared to usual Children's Aid Society risk assessment and~     protection service alone.~   "
229027|NCT00559195|"~     RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve~     fatigue in patients with malignant solid tumors receiving palliative care.~      PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and~     anemia in patients receiving palliative care for malignant solid tumors.~   "
229028|NCT00559182|"~     This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II~     Dose (RP2D), pharmacodynamic, and clinical activity of MK-8033.~      Parts A and B of the study will determine the maximum tolerated dose (MTD) and RP2D. Part C~     of the study will be a single panel crossover study to determine the effect of omeprazole, a~     gastric pH modifier, on the pharmacokinetics of MK-8033.~   "
229029|NCT00559169|"~     One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related~     to the over expression of multidrug resistance proteins (MDR). Progesterone is a known~     inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate~     seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the~     menstrual cycle. Verapamil suppresses seizures in animal models of epilepsy perhaps by~     inhibiting MDRs and thus may help patients with refractory seizures. If the study shows~     improved seizure control, the results will help establish the role of MDRs in refractory~     epilepsy.~   "
229030|NCT00559156|"~     RATIONALE: Giving a nutritional supplement containing arginine, omega-3 fatty acids, and~     nucleotides to patients undergoing chemotherapy and radiation therapy may stimulate the~     immune system and help the body build a stronger immune response.~      PURPOSE: This phase II trial is studying how well an arginine/omega-3 fatty acids/nucleotides~     nutritional supplement works in treating patients with stage III or stage IV head and neck~     cancer undergoing chemotherapy and radiation therapy.~   "
229031|NCT00559143|"~     Aim of present study is to examine the short and long-term results of pacing from right~     ventricular apex and to compare them with those of biventricular pacing.~   "
229032|NCT00559130|"~     The hypothesis of this study is use of CytoSorb hemoperfusion device as an adjunctive therapy~     to the standard of care in treating ARDS/ALI patients in the setting of sepsis will result in~     improved clearance of cytokines when compared to control patients receiving only the standard~     of care.~   "
229033|NCT00559117|"~     Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in~     Patients with Advanced Metastatic Cancer~   "
229034|NCT00559104|"~     RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous~     peripheral stem cell transplant stops the growth of cancer cells by stopping them from~     dividing or killing them. The patient's stem cells are then returned to the patient to~     replace the blood-forming cells that were destroyed by the chemotherapy and radiation~     therapy.~      PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy~     together with or without total-body irradiation followed by a stem cell transplant and to see~     how well it works in treating patients with non-Hodgkin lymphoma.~   "
229035|NCT00559091|"~     The purpose of this study is to determine if ribavirin (a drug commonly used to treat~     hepatitis C) also has activity in the treatment of patients with refractory or relapsed acute~     myeloid leukemia (AML) of the M4 and M5 subtype.~   "
229036|NCT00559078|"~     This qualitative interview-based study will investigate the impact that living with~     congenital adrenal hyperplasia has for women in the following areas: health-related quality~     of life (HRQL), psychological health, and health-seeking behaviors.~   "
229051|NCT00558870|"~     Objectives:~      Primary Objective:~      To determine whether the addition of low dose methadone to morphine(in the methadone group)~     has a lower dose escalation index as compared to the morphine alone(in the morphine group) at~     Day 15 (+/- 3 days)~      Secondary Objectives:~      To determine whether individuals on the methadone arm have lower pain intensity than the~     morphine alone arm as demonstrated by a decrease in two points from baseline (+/- 3 days) in~     their ESAS score at Day 15 (+/- 3 days).~      To determine whether the methadone group of experiences fewer opioid induced neurotoxic side~     effects (including sedation, myoclonus, hallucinations, hyperalgesia and confusion) as~     compared to the morphine alone group at Day 15 (+/- 3 days).~   "
229037|NCT00559065|"~     This study will examine the risks of workplace exposure to benzene, a substance known to lead~     to cancer of the blood and possibly of the lungs. It is used widely in industries and is a~     contaminant in the environment. Researchers from the National Cancer Institute and the China~     Center for Disease Control (formerly Chinese Academy of Preventive Medicine) had done~     previous studies of workers in manufacturing industries in China of people who worked at~     least 1 day from 1972 to 1987 in 12 cities in that country. Data were collected of~     approximately 75,000 workers exposed to benzene and 35,000 who were not, with the purpose of~     investigating the relationship between benzene exposure and cancer risk. For workers exposed~     to benzene, there was a significant risk of cancer affecting the blood cells and a 1.8-fold~     excess of lung cancer among them. This study will expand those findings and also identify the~     effects of benzene amounts and whether there is a genetic tendency for benzene poisoning.~     About 3,860 benzene-exposed workers from the 12 cities will be interviewed. Next-of-kin of~     deceased workers, and a subcohort (additional grouping) of participants will serve as a~     control group in the research.~      Patients who have worked at places where there was exposure to benzene will have a brief~     physical exam and samples of cells from a mouth rinse and samples from blood will be~     collected to study the genetic influence on developing blood diseases from workplace~     exposures.~      All participants or next-of-kin, for deceased, will be given a questionnaire about their work~     history, use of cigarettes and hair dyes, medications they take, and family history of~     cancer. Interviews of about 40 minutes long will be conducted at participants homes or~     workplaces, at a time convenient to them, and the interviews will be audiotaped.~   "
229038|NCT00559052|"~     EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as~     chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI.~     The current treatment of EPI includes enzyme supplementation with porcine pancreatic enzyme~     concentrate, consisting mainly of lipase, amylase and protease. An enzyme preparation able to~     deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small~     bowel, would appear to be clinically efficacious for the treatment of steatorrhea in subjects~     with CP suffering from EPI.~   "
229039|NCT00559039|"~     RATIONALE: Gathering information about pregnancy, infancy, and early childhood exposures may~     help doctors identify cancer risk factors, and may help the study of cancer.~      PURPOSE: This natural history study is looking at the effects of fetal, infant, and early~     childhood exposures on adult cancer risk in women.~   "
229040|NCT00559026|"~     This phase I/II study is directed at evaluating safety and immunogenicity of a melanoma~     peptide vaccine in combination or not with Dacarbazine administration in melanoma patients~   "
229041|NCT00559013|"~     Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement~     to minimize the risk of leakage during or after colo-rectal surgery.~   "
229042|NCT00559000|"~     The purpose of the study is to assess the effectiveness of KIDNET in treating traumatized~     refugee children in Germany~   "
229043|NCT00558987|"~     The purpose of this study is to test the effectiveness of a video-based parent education~     intervention delivered in the primary care setting on parents and other caregivers discipline~     attitudes and practices.~   "
229044|NCT00558961|"~     The purpose of this study is to determine maximum tolerated dose of Gleevec in combination~     with Chlorambucil in previously treated CLL patients.~   "
229045|NCT00558948|"~     The purpose of the study is to evaluate bone mineral density and muscle strength in survivors~     of bone marrow transplant. Association with age, type of transplant, steroids, years since~     transplant, body composition, endocrinopathies, radiation, quality of life and physical~     activity will be explored.~   "
229046|NCT00558935|"~     The purpose of this study is to investigate the effects of red wine on ABCA1 levels~   "
229047|NCT00558922|"~     This is an open-label multicenter, phase 1-2 study. Following determination of the~     recommended AEG35156 dose in combination with carboplatin and paclitaxel in the initial Phase~     1 part of this study, additional patients will be enrolled in the Phase 2 part of the study~     to assess the activity of the combination in advanced non small cell lung cancer.~   "
229048|NCT00558909|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 44847 in male and female patients with type 2 diabetes following oral administration of~     repeated doses of 100 mg b.i.d, 400 mg b.i.d. and 800 mg b.i.d. over 28 days.~      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI~     44847 after multiple dosing, including assessment of steady state.~   "
229049|NCT00558896|"~     RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in~     different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the~     growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with~     dexamethasone may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone~     works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.~   "
229050|NCT00558883|"~     Acarbose an alphaglucosidase inhibitor changes in a complex way the transport, the digestion~     and the place of glucose release and absorption. As a result the intestinal milieu, the~     intestinal flora and the provision of enzymes in the lower small destine are changed. This~     should modify immune response of intestinal wall on food and its proinflammatory effects. The~     small intestine is the biggest immune organ of the organism. The postprandial glucose~     increase could have a direct effect on low-grade inflammation. Toxic effects (glucotoxicity),~     activation of the immune system and low grad inflammation could be reasons of developing~     endothelial dysfunction and affect plaque stability. The activity of the lymphocyte immune~     system in the intestine would be a further component, by which acarbose could take influence~     on diabetogenesis and atherogenesis. The question of an enterovasal axis is one of the new~     research concepts. As indicators of this axis considered: leucocytes, high sensitive~     C-reactive protein, plasminogen activator inhibitor antigen and lymphocytes sub-populations.~     The effect of acarbose on these parameters in the postprandial phase are not known yet.~   "
229052|NCT00558857|"~     This is a prospective, non-randomized study to determine the feasibility of using a new~     technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic~     ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective~     ablation of IVT. Results from this study will be used to determine if further clinical~     investigation is warranted.~   "
229059|NCT00558766|"~     Background:~      The brain releases signals to mark rewards for certain behavior. Some medications for~     Parkinson disease (PD) can cause some patients to engage in compulsive behavior, possibly~     because the medications affect this reward system.~      By using transcranial magnetic stimulation (TMS), researchers can study brain activity when~     an individual receives a reward.~      Objectives:~      To learn how the brains of people with PD behave when rewarded.~      To learn whether two common Parkinson medications (levodopa and pramipexole) change this~     behavior.~      To compare reward signals in the brains of healthy volunteers with reward signals in the~     brains of people with PD.~      Eligibility:~      Women between 50 and 80 years of age and men between 45 and 80 years of age.~      Participants will be divided into healthy volunteers and volunteers who have mild to moderate~     PD.~      Design:~      Prescreening will consist of a neurological examination and a series of questions about~     gambling habits and drug and alcohol use.~      Participation in a TMS study involving a computer game simulation of a slot machine:~        -  Before the simulation, participants will receive TMS to establish a baseline response~          rate.~        -  During the simulation, participants will play a game in which they will receive real~          money.~      TMS will be administered to each patient under three different conditions:~        -  TMS administered when patients have not taken any Parkinson medication.~        -  TMS administered after patients have taken levodopa.~        -  TMS administered after patients have taken pramipexole....~   "
229060|NCT00558753|"~     The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin~     given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the~     prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The~     prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA)~     is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main~     classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected~     limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor,~     including sweating; and movement disorders and dystrophy, including decreased range of~     motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.~   "
229061|NCT00558740|"~     Individuals submitted to a high-fat or a high-fructose/sucrose diet develop, over a 6~     day-period, several features of the metabolic syndrome, including increased plasma~     triglycerides, increased intrahepatic lipids, and decreased hepatic insulin sensitivity. It~     has been recently observed that the increase in intrahepatic lipids observed after a high fat~     diet is largely prevented when protein intake is concomitantly increased. This suggests that~     dietary protein protects the liver against some of the deleterious effects of a high fat~     diet. Mechanisms underlying this effect of protein may include an increased hepatic fat~     oxidation.~      The aims of this study are:~        1. to evaluate the effects of dietary protein on several major pathways involved in hepatic~          lipid metabolism ( ketogenesis, lipid oxidation, de novo lipogenesis, VLDL-triglyceride~          secretion~        2. to determine whether the decrease in intra-hepatic lipids observed when dietary protein~          intake is increased are to be attributed to acute or long-term effects of proteins~   "
229062|NCT00558727|"~     This is a Phase 1, nonrandomized, open-label, dose-escalation study of 3-hour IV infusions of~     RH-1 administered to patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL).~      Treatment will continue until a patient meets criteria for discontinuation.~   "
229063|NCT00558701|"~     This single-center, prospective, randomized, and controlled study evaluated the efficacy of~     silver-coated dressing with active microcurrent in comparison to silver-coated dressing with~     sham microcurrent on wound-closure time for autogenous skin donor sites.~   "
229064|NCT00558688|"~     The purpose of this study is to compare the efficacy of photodynamic therapy with~     5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.~   "
229065|NCT00558675|"~     The purpose of this study is to determine the safety and anti-tumor effects of an~     experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune~     cells which are designed to elicit the same anti-tumor mechanism that occurs in allogeneic~     bone marrow/stem cell mini-transplant (BMT) procedures, without the toxicity associated with~     graft vs. host disease (GVHD).~   "
229066|NCT00558662|"~     The study purpose is to compare healing rates, cost effectiveness, quality of life and safety~     of 12 week compression therapy for the treatment of venous leg ulcers with the 3M™ Coban™ 2~     Layer Compression System versus short-stretch compression bandage.~   "
229067|NCT00558649|"~     The purpose of this study is to determine whether low dose flu vaccines delivered with~     microneedles into the skin (intradermally) are effective.~   "
229068|NCT00558636|"~     The purpose of this study conducted in Asia-Pacific was to evaluate the efficacy and safety~     of Sorafenib in combination with paclitaxel and carboplatin versus placebo in combination~     with paclitaxel and carboplatin for chemonaive patients with unresectable stage IIIB (with~     effusion) or stage IV NSCLC. However, as indicated below, the study was terminated~     prematurely when the results from Study 11961 (NCT00300885), an earlier Phase 3 study of~     similar design in subjects with advanced NSCLC, showed an overall lack of efficacy and~     increased mortality in subjects with squamous subtype. The data available is presented as~     descriptive analyses, due to the limitations of implementing the statistical analysis plan.~   "
229069|NCT00558623|"~     Lead accumulates in bone. During pregnancy, physiologic changes occur prompting bone~     resorption in order to provide calcium to the growing fetal skeleton also release the lead~     stored in bone into a pregnant woman's circulation. We have previously demonstrated that lead~     stores mobilized into the circulation of pregnant women pose a major threat to fetal~     development. This is particularly unfortunate since bone lead stores, once accumulated,~     persist for decades, thereby jeopardizing the pregnancies of women even if their current lead~     exposures have subsided. What then can be done for the many thousands of women who have had~     lead exposure while growing up and who want to have healthy children? To address this~     question, in 2000, this project embarked on a randomized intervention trial to test whether a~     bedtime nutritional supplement of 1,000 mg of calcium can significantly reduce fetal lead~     exposure and toxicity by suppressing bone resorption in the pregnant mother.~   "
229070|NCT00558597|"~     In patients with acute rejection after lung transplantation the peptide profile in~     broncho-alveolar lavage (BAL) and urine should be compared in order to identify a paradigm~     that allows an non-invasive rejection therapy.~   "
229073|NCT00558558|"~     Primary:~        -  To determine if treatment with Haelan (fermented soy product) can decrease the severity~          of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best,~          100 mm = worst) at week 4 +/- 5 days.~        -  To determine if treatment with Haelan can decrease the severity of nausea, fatigue, and~          improve patients' overall sense of well being measured using a VAS of 0 to 100 mm (0 mm~          = best, 100 mm = worst) at week 4 +/- 5 days.~        -  To determine if treatment with Haelan can increase patient's calorie intake, albumin,~          pre-albumin, anthropometric measure, lean body mass (measured by bio-impedence~          analysis), and weight at week 4+/- 5 days.~        -  To determine if treatment with Haelan can decrease patient's Functional assessment of~          anorexia/cachexia therapy subscales or (FAACT) and the Functional Assessment of Chronic~          Illness Therapy with fatigue subscales (FACIT-F) at week 4+/- 5 days.~        -  To assess the feasibility of accrual, and adherence to the Haelan consumption.~      Secondary:~        -  Determine the plasma isoflavone activity, 12-MTA and 13-MTA of these patients.~        -  Correlate the biologic modulation of peripheral blood lymphocyte NF-kB by Haelan with~          primary outcome in these patients.~        -  To determine if treatment with Haelan can increase patient's functional status at week~          4+/- 5 days.~   "
229074|NCT00558545|"~     This is an open-label multicenter, phase 1-2 study. Following determination of the~     recommended AEG35156 dose in combination with weekly paclitaxel in the initial Phase 1 part~     of this study, additional patients will be enrolled in the Phase 2 part of the study to~     assess the activity of the combination in advanced breast cancer.~   "
229075|NCT00558532|"~     The purpose of this study is to determine the concentration of omega-3 fatty acids in plasma,~     blood and abdominal fat before and after bariatric surgery to provide guidance for future~     studies.~   "
229076|NCT00558519|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     young patients with newly diagnosed acute lymphoblastic leukemia.~   "
229077|NCT00558506|"~     This is an open-label trial investigating the efficacy and safety of abatacept in ankylosing~     spondylitis. It is planned to treat 30 patients with ankylosing spondylitis from baseline up~     to week 30. Abatacept will be administered intravenously according to the prescription used~     in rheumatoid arthritis.~   "
229078|NCT00558493|"~     A multi-center and open study to compare the safety and effectiveness of switching treatment~     from lamivudine to clevudine for 24 weeks.~   "
229079|NCT00558480|"~     In populations with high prevalence of latent tuberculosis infection (LTBI), malnutrition~     (PEM) may influence incident rates of TB. PEM and specific micronutrient deficiencies~     compromise cell mediated immunity (CMI) and increase susceptibility to, or severity of~     infections. Vitamin A supplementation significantly reduces all-cause child mortality. The~     mechanism of the benefits of supplementation on clinical outcomes is largely unknown, but is~     likely to be related to an influence on the immune system. Vitamin A supplementation promotes~     lymphogenesis and induces a higher proportion of CD4 naïve T-cells in children. Most cases of~     LTBI that progress to active disease are vitamin A deficient. Vitamin A deficiency is common~     in most TB endemic countries. At the MRC, 32% of TBCC contacts were vitamin A deficient.~      Hypothesis:~      The investigators plan to test the hypotheses: that supplementation with vitamin A will~     affect the magnitude and quality of immune responses to mycobacterial antigens and~     progression to clinical disease.~   "
229080|NCT00558467|"~     A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and~     safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with~     Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the~     Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.~   "
229081|NCT00558454|"~     Iron is essential for brain development and there is a well established association between~     iron deficiency in infants and poor neurological development. In Sweden, about 5% of newborns~     have low birth weight (< 2500 g). Due to small iron stores at birth and rapid postnatal~     growth, they have increased risk of iron deficiency and it is therefore important to prevent~     iron deficiency in this population. However, excessive iron supplementation can have adverse~     effects in infants such as growth impairment. In a randomized, controlled trial, we are~     investigating the effects of 0, 1 or 2 mg/kg/d of iron on brain myelination, cognitive~     development and growth in low birth weight infants.~   "
229082|NCT00558441|"~     The study purpose is to prospectively collect data for a set of predefined variables in~     clinical cases where coronary plaque lipid characterization by IVMRI was performed during~     diagnostic or interventional procedures in order to gather incremental information beyond~     angiography and other diagnostic modalities.~   "
229083|NCT00558428|"~     The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination~     T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight~     weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the~     fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks~     compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose~     combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to~     A10 in patients who fail to respond adequately to six weeks treatment with A5.~   "
229084|NCT00558402|"~     The goal is to determine how 6-week stress reduction techniques may decrease stress in~     primary caregivers of people with Alzheimer's disease. The 3 intervention programs are~     meditation, education, and respite care. There will be approximately 108 subjects over 3~     years. Subjects will have a screening session over the phone to see if they are eligible~     (50-85 years old, spending at least 12 hours per week caring for a close relative with~     Alzheimer's disease, willing to be in any of the 3 groups, and without any very serious~     medical problem). The subjects will have 3 testing sessions, 1 before classes/respite and 2~     after classes are over, each lasting about 3 hours. The classes are taught in a one-on-one~     setting, and they are 50 minutes per week for 6 weeks. Respite care is provided for the~     person with Alzheimer's disease in all the groups. Measurements include people's ratings of~     stress, psychological testing, and biological measurements of stress, including the~     following: saliva, blood, and urine collection; waist-to-hip ratio; weight; blood pressure;~     heart rate; respiration; reaction time task; voice recordings; electrocardiogram;~     electroencephalogram; and electro dermal activity.~   "
229085|NCT00558376|"~     The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium~     phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation~     with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is~     advantage for substituting the purgative used, as compared to repeating the colonoscopy with~     the same purgative.Briefly, patients whose preparation was inadequate, will be allocated~     randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive~     sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days.~     Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced~     endoscopist.~   "
229086|NCT00558363|"~     ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial~     assessing the efficacy and safety of dutasteride in extending time to prostate specific~     antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer~     (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage~     radiotherapy) with curative intent but who experience a biochemical failure (PSA rise)~     afterwards without signs or symptoms of metastases.~   "
229087|NCT00558350|"~     Inflammatory reaction in different compartments of the body may have a negative effect on~     outcome. This study assesses the inflammatory reaction systemically, intrapulmonary and~     intrapleural by measuring different cytokines. Patients with lung cancer undergoing lobectomy~     or segmentectomy are included in the study. Hypothesis: The inflammatory reaction in the~     pleural space is high compared to the systemic and intrapulmonary ones.~   "
229088|NCT00558337|"~     Determine if a novel levodopa/carbidopa formulation results in a better clinical response on~     Parkinson's Disease patients compared to the reference formulation of levodopa/carbidopa in~     terms of motor complications, onset of action and response duration.~   "
229089|NCT00558324|"~     Determine the flap thickness created by femtosecond laser or a mechanical microkeratome using~     in vivo confocal microscopy and compare measured versus intended flap thickness.~   "
229090|NCT00558311|"~     The aim of this study is to demonstrate that clazosentan, administered as a continuous~     intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH),~     reduces the incidence of cerebral vasospasm -related morbidity and all-cause mortality within~     6 weeks post-aSAH treated by surgical clipping. The primary endpoint of the study is the~     occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6~     weeks post-aSAH, defined by at least one of the following:~        1. Death (all causes).~        2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant~          contributing cause, or not adjudicated to be entirely due to causes other than~          vasospasm.~        3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the~          primary or relevant contributing cause, or not adjudicated to be entirely due to causes~          other than vasospasm.~        4. Neurological signs or symptoms (depending on state of consciousness), in the presence of~          confirmed cerebral vasospasm on angiography (DSA or CTA), leading to the administration~          of a valid rescue therapy.~      An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet~     the primary endpoint and its individual morbidity components.~   "
229091|NCT00558298|"~     The purpose of this study is to document the long-term safety of 25, 50 or 75 mg long-acting~     injectable risperidone given via injection to the gluteal muscle every 2 weeks to patients~     with schizophrenia or schizoaffective disorder.~   "
229092|NCT00558285|"~     An investigational inhalation product (QVA149) for the treatment of patients with Chronic~     Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate~     the effect on heart rate and cardiovascular effects to ensure the product is safe.~   "
229093|NCT00558272|"~     The purpose of this study is to determine the effect of AZD0530 on subjects with breast~     cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.~   "
229094|NCT00558259|"~     The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to~     placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in~     patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed~     6 to 18 months of treatment with vitamin K antagonist (VKA).~   "
229095|NCT00558246|"~     This is a prospective, controlled, randomized, multi-center clinical study of up to 80~     patients with full thickness surgical incisions associated with bi-lateral breast procedures.~     Breast procedures where symmetrical incisions of at least 15cm in length are planned for both~     breast (bilateral procedure) will be randomised to receive final skin closure of one breast~     with Prineo (DERMABOND PROTAPE) and the other with intradermal sutures (control). Patients~     will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days,~     and 90 days (± 10 days).~   "
229096|NCT00558233|"~     The purpose of this study is to determine whether a multimedia educational computer program~     can increase colorectal cancer screening rates in low and adequate literacy patients.~   "
229097|NCT00558220|"~     The purpose of this study is to show if addition of Rituximab to intensive induction~     (MegaCHOP/ESHAP) and high-dose consolidation (BEAM) improves progression-free and overall~     survival in patients younger than 65 years with aggressive B-cell lymphoma and aaIPI 2 or 3.~   "
229098|NCT00558207|"~     This is a multi-center, open-label randomized phase 2 study designed to assess the~     progression free survival (PFS) of patients with untreatment and unresectable pancreatic~     cancer following treatment with either ARQ 197 or gemcitabine. The study will also evaluate~     other efficacy and safety endpoints including overall response rate, overall survival and~     adverse events in the two treatment arms.~   "
229112|NCT00558025|"~     The objectives of this trial conducted in early Parkinson's disease (PD) patients are:~        -  To assess if patients with early Parkinson's disease (PD) can be successfully switched~          (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole~          Extended Release (ER). A successful switch at a specific visit is defined as no~          worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by~          more than 15% from baseline and no drug-related adverse events leading to withdrawal;~        -  To establish if this successful switch can be obtained with or without dose-adaptation;~        -  To provide information about the conversion ratio (mg:mg) from Pramipexole IR to~          Pramipexole ER.~   "
246373|NCT00328354|"~     The goal is to conduct a pilot study to determine the feasibility of the clinical use of~     RMSSH SPECT imaging technology for breast imaging and to develop a standardized clinical~     protocol.~   "
229099|NCT00558194|"~     Behavioral weight loss, the current treatment of choice for moderate obesity, achieves~     impressive short term results, however, weight regain following treatment is a major problem.~     Over 50% of participants in behavioral weight loss programs report difficulty with internal~     antecedents to unhealthy weight control behaviors and this difficulty is associated with~     weight regain following treatment. Current treatment approaches do not adequately address~     these antecedents. The aim of this series of studies is to develop, implement, and evaluate a~     behavioral weight loss program modified to provide participants with skills to deal~     effectively with affective and cognitive difficulties. The study targets men and women with~     BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to~     unhealthy weight control behaviors. The study will randomize 120 participants to receive 12~     months of standard behavioral therapy for weight loss or standard behavioral treatment plus~     affective and cognitive skills training. The long-term goal of this research is to improve~     the weight loss maintenance outcomes of behavioral weight loss programs by addressing~     affective and cognitive antecedents to unhealthy weight control behaviors.~   "
229100|NCT00558181|"~     Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents~     are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53~     apoptosis pathway. The combination of both drugs may improve response and outcome in~     previously treated high-risk B-CLL patients.~      Study Objectives~      Primary:~      To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously~     treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate.~      Secondary:~      To determine progression free and overall survival. To characterize the safety profile of~     high-dose Methylprednisolone and Rituximab.~   "
229101|NCT00558168|"~     Collecting information regarding adverse events from patients on treatment with anastrazole~     with early stage breast cancer~   "
229102|NCT00558155|"~     The aim of the study was to assess the clinical effect of immunostimulatory enteral and~     parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205~     subjects were randomly assigned into four study groups, standard and immunostimulating,~     enteral and parenteral. The study was designed to test the hypothesis that immunonutrition~     and enteral nutrition would reduce the incidence of infectious complications following upper~     gastrointestinal surgery.~   "
229103|NCT00558142|"~     Millions of people receive radiographic contrast material for investigations like CT and~     coronary angiography. While considered safe in healthy patients, it can cause acute renal~     impairment. This is termed radiocontrast-induced nephropathy (RCIN) and is generally defined~     as an increase in serum creatinine over baseline of more than 25% or 0.5 mg/dL (44.2 μmol/l)~     within 48 hrs. RCIN occurs in less than 2% of patients with normal renal function but is more~     common in patients with pre-existing renal damage.~      The pathophysiology of RCIN is unclear. Possible mechanisms involve 1) reduced renal blood~     flow leading to acute tubular necrosis and 2) direct renal tubular injury by oxygen free~     radicals. Current prevention strategies focus on increasing renal blood flow and reducing~     oxidative stress. Patients at risk of RCIN currently receive fluids, a low dose of contrast,~     and variable and unproven doses of acetylcysteine.~      The evidence for acetylcysteine administration is unclear. A RCIN consensus working group~     reported in the American Journal of Cardiology in September 2006 that N-acetylcysteine is~     not consistently effective in reducing the risk for contrast-induced nephropathy. The~     perception of a benefit from acetylcysteine administration that is unproven has disadvantages~     as some clinicians report giving larger amounts of radio-contrast to patients who have~     received acetylcysteine since they believe that it prevents RCIN. There is a need to~     determine how acetylcysteine might prevent RCIN and to identify the appropriate dose and~     route of administration.~      Since acetylcysteine is a vasodilator as well as an antioxidant, it may work in two distinct~     ways, by preventing reduction in renal blood flow (RBF) or contrast-induced oxidative damage.~     Previous studies have used changes in serum creatinine. In addition to being an insensitive~     marker of altered renal function, if contrast causes renal vasoconstriction and~     acetylcysteine vasodilatation, changes in serum creatinine will not be the ideal marker of~     effect. Finally the optimum dose and route of acetylcysteine administration is unclear, as~     illustrated by studies using a variety of doses and routes.~      We propose to study the mechanism of effects of acetylcysteine on healthy and diseased~     kidneys, both unstressed and stressed by radiocontrast administration. We hypothesise that~     acetylcysteine may exert a renoprotective effect in RCIN by a renal vasodilatation and/or~     antioxidant mechanism.~   "
229104|NCT00558129|"~     To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that~     of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich~     Claudication Questionnaire.~   "
229105|NCT00558116|"~     The Purpose of this study is to examine the effect of using the Carpal Tunnel Dynasplint®~     System on patients diagnosed with CTS in a randomized, controlled, cross-over study.~   "
229106|NCT00558103|"~     The double blind part of the study is being conducted to compare the efficacy and safety of~     pazopanib in combination with lapatinib with that of lapatinib alone in subjects with~     inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an~     Open-label pazopanib arm to this study designed to test whether pazopanib given alone and~     lapatinib given alone would be safe and effective to treat patients with inflammatory breast~     cancer.~   "
229107|NCT00558090|"~     The purpose of this study is to determine the influence of morphine 2,5 mg or morphine 7,5 mg~     iv during a painful and unavoidable intervention in critically ill patients.~   "
229108|NCT00558077|"~     To date, it is still unclear the potential role of laparoscopic ovarian diathermy (LOD) in~     the management of polycystic ovary syndrome (PCOS)-related anovulatory infertility. Metformin~     administration, alone or combined with clomiphene citrate (CC), has shown to be an effective~     and attractive second-line treatment for ovulation induction in women with polycystic ovary~     syndrome (PCOS) after failure of CC treatment. The aim of the present study will be to~     compare in a randomized controlled fashion the efficacy of LOD with metformin plus CC~     administration in the treatment of the CC-resistant PCOS patients.~   "
229109|NCT00558064|"~     To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is~     superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately~     controlled with amlodipine 5 mg monotherapy.~   "
229110|NCT00558051|"~     The purpose of this study is to evaluate the administration, safety and immunologic~     effectiveness of an experimental vaccine for colorectal cancer patients.~   "
229111|NCT00558038|"~     The purpose of this study is to evaluate the safety and effectiveness of the experimental~     drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.~   "
229123|NCT00557882|"~     The primary aim of this double-blind, randomized clinical trial (RCT) is to test the~     hypothesis that the addition of a standardized technique of interpositional synthetic~     polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery~     for anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.~   "
229273|NCT00555789|"~     This study will provide continued treatment and assess the long term safety, efficacy and~     tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after~     kidney transplantation.~   "
229113|NCT00558012|"~     This trial will examine the safety, efficacy and feasibility of a single dose of intravenous~     zoledronic acid in the maintenance of skeletal integrity for frail, institutionalized women,~     who are most at risk for the deleterious outcomes of osteoporosis. The investigators will~     test the hypothesis that in institutionalized elderly women a single dose of intravenous~     zoledronic acid therapy will: (1) be efficacious as demonstrated by stability or improvement~     in bone mass measurements and reductions in bone turnover; (2) be safe and feasible; and (3)~     provide estimates for vertebral and nonvertebral fracture reduction in this cohort for use in~     planning a future study.~   "
229114|NCT00557999|"~     The following objectives were used for comparison: 1) primary objective: reintubation rate~     during hospitalization; 2) secondary objectives: length of hospitalization at the Coronary~     Care Unit; time from intubation to start of weaning; time from start of weaning to~     extubation; time from SBT and extubation; presence of respiratory infection in patients~     requiring reintubation; mortality of patients requiring reintubation.~   "
229115|NCT00557986|"~     Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and~     surgery is reserved for tumor related complications such as bleeding. Retrospective studies~     showed that surgical removal of the primary tumor improves survival of patients with~     metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the~     primary tumor will lead to an improvement of overall survival~   "
229116|NCT00557973|"~     The purpose of this study is to evaluate efficacy and safety of treatment with XP19986~     Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal~     cord injury~   "
229117|NCT00557960|"~     Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on~     simulated driving safety and performance of young adults with ADHD as measured by Driving~     Safety Scores derived by the Driving Simulator.~   "
229118|NCT00557947|"~     This is a prospective, controlled, randomized, multi-center clinical study of up to 80~     subjects with full thickness surgical incisions. Each incision included in the study will be~     segmented into two halves; each half will be randomized to receive final skin closure with~     either Prineo (DERMABOND PROTAPE) or intradermal sutures. Subjects will be evaluated~     post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10~     days).~   "
229119|NCT00557934|"~     Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in~     particular the use of a transannular patch, has been shown to correlate with the development~     of right ventricular dysfunction. Optimal timing of pulmonary valve replacement, therefore,~     is important to preserve right ventricular function. Several recent studies suggested that a~     threshold of right ventricular end-diastolic volume for intervention, in order to preserve~     the likelihood of adequate reverse remodeling, is in the region of 150 to 200 ml/m2 body~     surface area. However, there is evidence that right ventricular function does not always~     recover following pulmonary valve replacement even if the end-diastolic volume is below this~     cut-off.~      In addition, previous studies suggested that early dysfunction may be present before symptoms~     occur. However, early dysfunction is difficult to assess.~      Methods: Analysis of right ventricular function by pressure-volume loops has been extensively~     evaluated in experimental studies and is generally considered the optimal way to quantify~     right ventricular function.~      By recording a family of pressure-volume loops during reduction of preload, achieved by~     temporary balloon occlusion of the inferior caval vein, the contractility can be calculated~     by the slope of the endsystolic pressure-volume relation (elastance). Changes of~     contractility following dobutamine infusion could be noted by changes of elastance. The~     increase of the slope during dobutamine demonstrates the contractility reserve of the right~     ventricle.~      Purpose: To evaluate the right ventricular contractility reserve to determine early~     ventricular dysfunction after repair of tetralogy of Fallot.~   "
229120|NCT00557921|"~     The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and~     omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of~     gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant~     aspirin therapy.~      Antiplatelet therapy is an essential element of care for patients with atherothrombotic~     disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including~     aspirin, clopidogrel and dual antiplatelet regimens.~      The gastrointestinal tract is the most common site of bleeding related to antiplatelet~     therapy, typically in connection with peptic ulcer disease. Recently published studies~     suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of~     aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of~     these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher~     risk of bleeding and ulcer disease.~      Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product,~     CGT-2168, which has the potential to significantly reduce this problem and increase patient~     safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant~     (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal~     events.~   "
229121|NCT00557908|"~     The von Willebrand Disease Prophylaxis Network (VWD PN) is an international study group~     formed with the goal of investigating the role of prophylaxis in clinically severe VWD that~     is non-responsive to other treatment(s).~   "
229122|NCT00557895|"~     This study will evaluate and follow patients with various allergic, hypersensitivity and~     inflammatory disorders. The protocol is not designed to test new treatments; patients will be~     managed with standard of care therapies. Participants may be referred to other current NIAID~     protocols as appropriate or to new studies as they are developed, but will not be required to~     join another study.~      Patients with allergic, hypersensitivity or inflammatory disorders between the ages of 3~     years and 80 years may be eligible for this study. Conditions of interest include, but are~     not limited to, asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy.~      Participants will have a medical history and physical examination, plus standard tests for~     diagnosing and treating their specific disorder. Tests may include routine blood and urine~     studies, X-rays or other imaging studies, allergy skin tests and lung function tests. Blood~     samples may be collected for research on immune system cells and other substances involved in~     immune function. Generally, about 2 to 6 tablespoons will be drawn at a time, but no more~     than 16 ounces will be collected over a 6-week period.~      NIH does not provide emergency medical treatment or treatment for other, unrelated conditions~     the patient may have. Therefore, patients must maintain a personal physician for these~     purposes.~   "
229124|NCT00557869|"~     The aim of the present study is the optimization of various magnetic resonance (MR)~     investigation protocols of the heart and the lung without contrast agent application as well~     as the generation of normal values from cardiac MR images. One of the main problems in~     cardiac MR investigations is the strong dependence of the achieved image quality on optimal~     settings of sequence parameters and anatomical and physiological situations with special~     emphasis on phase-contrast imaging and other cine-techniques.~   "
229125|NCT00557856|"~     The purpose of this study is to test the safety and effectiveness of PF-03446962 when given~     as a single agent. Tumors require new blood vessels to support their ability to grow and to~     spread (metastasize). New treatments aimed at preventing these blood vessels have the ability~     to improve the clinical management of cancer.~   "
229126|NCT00557843|"~     The primary objective is to evaluate the influence of continuous local anesthetic~     infiltration on tissue oxygenation after surgical procedures requiring abdominal surgery as a~     major predictor for wound healing.~   "
229127|NCT00557830|"~     The primary objective of this study is to compare the effectiveness of a dose-escalation~     regimen (400 to 800mg bid) relative to the standard dosing regimen (400mg bid) of sorafenib~     given in patients with metastatic RCC.~      The secondary objectives are to evaluate the effects of the dose-escalation regimen on the~     quality of life (QoL) of patients with metastatic RCC and to characterize the safety and~     tolerability profile of a dose-escalation regimen of sorafenib in patients with metastatic~     RCC.~   "
229128|NCT00557817|"~     Darbepoetin-alpha and i.v. iron administration after autologous hematopoietic stem cell~     transplantation for hematological malignancies : a prospective randomized trial.~   "
229129|NCT00557804|"~     This is a multi-center, non-randomized study designed to develop an external monitor for CHF~     patients.~   "
229130|NCT00557791|"~     The purpose of this study is to compare the safety and effectiveness of three doses of~     intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration~     following initiation of anti-VEGF therapy with three doses of Lucentis®.~   "
229131|NCT00557778|"~     Evaluate the benefit (rate of adherence to the treatment), based on the LDL-C reduction in~     the group that will be exposed to the program of reinforcement of orientation aimed to the~     patients, compared to the control group, both in previous use of rosuvastatin.~   "
229132|NCT00557765|"~     After exposure to an active case of tuberculosis (TB), close contacts may be infected. They~     are then considered as having latent tuberculosis infection (LTBI). Detecting LTBI is the~     main goal of contact tracing procedures after exposure to TB. Until recently, the only test~     available for detecting LTBI was the tuberculin skin test (TST). More recent tests are now~     available (Interferon-gamma release assays: IGRA), which are more specific and sensitive than~     the TST. This study compares the TST and an IGRA in the routine activity of contact tracing~     in our area.~   "
229133|NCT00557752|"~     -  Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of~          these patients is near 20%.~        -  Treatment before intubation is needed, is based on pain control with epidural anesthesia~          and oxygen.~        -  The investigators' hypothesis is that adding non-invasive mechanical ventilation to the~          standard treatment can reduce the intubation rate if applied early in the course of the~          disease.~        -  As thoracic trauma is often associated with injuries in other body regions that may~          increase the complications of the technique, specific contraindications have been~          described.~   "
229134|NCT00557739|"~     CRx-191 is a proprietary synergistic combination drug candidate being evaluated by~     CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening~     assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor-~     alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of~     psoriasis.~      This clinical trial will assess the effectiveness of CRx-191 in reducing the psoriatic~     infiltrate band thickness as measured by transdermal ultrasound. All subjects will receive~     all treatments in separate test fields, with intra-individual comparison of the treatments.~   "
229135|NCT00557726|"~     This protocol is being established to cover the admission of patients with inflammatory~     and/or infectious diseases which are not covered under previously existing protocols. The~     purpose of such a protocol is that frequently patients are referred to us with either~     diagnosed or undiagnosed illnesses which would be of interest to our teaching program or~     which would serve as a source of patients to subsequently be entered into established,~     ongoing protocol studies. Such patients will be admitted and handled according to accepted~     medical practice of diagnosis and treatment.~   "
229136|NCT00557713|"~     The purpose of this study is to determine the pathological complete response rate of addition~     of bevacizumab to induction therapy (xelox) and concomitant treatment~     (capecitabine+radiotherapy), followed by surgery.~   "
229137|NCT00557700|"~     This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium~     bromide versus placebo.~   "
229138|NCT00557687|"~     The purpose of this study is to evaluate if there is an association between the endocrine and~     ultrasonographic markers of ovarian reserve and the IVF outcome and to determine which~     markers contribute to the prediction of poor response in IVF.~   "
229139|NCT00557661|"~     An open-label study designed to determine the safety, tolerability and pharmacodynamics of~     CD-NP infusions in heart failure patients.~   "
229140|NCT00557648|"~     This study will evaluate the effectiveness of school-based cognitive behavioral therapy with~     or without parental involvement in treating anxious children.~   "
229141|NCT00557635|"~     Sometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from~     Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a~     long time. To optimize this integration we purpose to associate mesenchymal progenitors cells~     from autologous bone marrow.~   "
229158|NCT00557401|"~     To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet~     compared to placebo in subjects with symptomatic GERD~   "
229215|NCT00556543|"~     The purpose of this study is to gather information about a device used to help fix broken~     ribs.~      Hypothesis: Rib fracture repair with the U-plate system is clinically durable and safe for~     the indications of flail chest repair, acute pain control, chest wall defect repair, and rib~     fracture non-union.~   "
229142|NCT00557622|"~     This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of~     BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over~     the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients~     with posttraumatic stress disorder (PTSD) as assessed by the change from baseline in CAPS-SX~     total score. Also the effect of paroxetine on regional cerebral blood flow (rCBF) induced by~     subthreshold emotional arousing (or symptom stimulating) tasks will be determined using~     functional magnetic resonance imaging (fMRI) for exploratory assessment of the correlation~     between the change in rCBF and the efficacy.~      The sample size is 30 subjects. The study period consists of 4 weeks of run-in phase, 12~     weeks of treatment phase, 0-3 weeks of taper phase and follow-up examination at 2 weeks after~     the last dose, for a total of 18-21 weeks.~      Subjects will visit the clinic at the start of run-in phase, Week -2, the start of treatment~     phase, Weeks 2, 4, 6, 8 and 12 of treatment, and follow-up examination.~   "
229143|NCT00557609|"~     This is a multi-center, single arm intended to evaluate the anti-tumor effect of ARQ 197 in~     patients with microphthalmia transcription factor associated (MiT) tumors. MiT tumors include~     clear cell sarcoma, alveolar soft parts sarcoma, and translocation associated renal cell~     carcinoma.~   "
229144|NCT00557596|"~     This is an open-label multicenter, phase 1-2 study. Following determination of the~     recommended AEG35156 dose in combination with gemcitabine in the initial Phase 1 part of this~     study, additional patients will be enrolled in the Phase 2 part of the study to assess the~     activity of the combination first-line in advanced pancreatic cancer.~   "
229145|NCT00557583|"~     The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy~     subjects.~   "
229146|NCT00557570|"~     This study is designed to learn more about HIV infection and the conditions associated with~     it.~      Patients 18 years of age or older with known or suspected HIV infection may be eligible for~     this study. Patients may have participated in previous NIH studies.~      Participants will have periodic physical examinations and blood tests, including evaluations~     for responses to treatment. Treatment consistent with accepted standard medical practice will~     be individualized for each patient. Patients who previously participated in a NIH study will~     be followed for possible long-term benefits or side effects of treatment. Patients treated~     with alpha-interferon or interleukin-2 (IL-2) may continue treatment with that medication if~     it is felt that they might benefit from it. Blood samples may be drawn as part of standard~     medical care and for research purposes. Other tests may be done as appropriate for diagnosis~     and treatment, including, for example, a chest X-ray, electrocardiogram, or tissue biopsy.~     Patients will be seen for follow-up visits at regular intervals to monitor treatment~     progress.~      Certain patients currently enrolled in a NIH study of IL-2 treatment may participate in a~     phase of the study that adds a corticosteroid, such as hydrocortisone, prednisone, or~     prednisonolone, to the regimen. Patients whose CD4 counts did not increase with IL-2 will~     receive corticosteroids (by mouth or by vein) in an open manner. Patients who responded to~     IL-2 therapy will be randomly assigned to receive corticosteroids or a placebo (inactive~     substance) during IL-2 infusions in a blinded manner, so that neither the patient nor the~     medical staff will know which patients are receiving the drug and which are receiving a~     placebo. Participants will be requested to receive at least three rounds of treatment with~     corticosteroid or placebo.~      Patients currently taking IL-2 by subcutaneous injection (under the skin) may participate in~     an optional part of the study to receive future IL-2 cycles at home instead of at or near the~     Clinical Center. Patients who have shown an ability to self-administer and tolerate IL-2~     injections with minimal supervision and minimal side effects may be eligible for this option.~     Home administration of IL-2 involves less frequent data and safety monitoring, and no on-site~     medical evaluation at the very beginning of each cycle. Participants will continue to be seen~     at the Clinical Center for regularly scheduled follow-up visits and medical evaluations~     before the start of each IL-2 cycle to determine if it is safe to begin that cycle. Patients~     will have a case manager who will place monitoring calls on days 2 and 4 of the cycle and a~     third follow-up call 1 week later. Patients will be responsible for contacting a study staff~     member if complications of other problems develop at other times.~   "
229147|NCT00557557|"~     The purpose of this study is to determine the maximum tolerated dose and dose limiting~     toxicity of 5-FU in combination with Oxaliplatin delivered via isolated hepatic perfusion.~   "
229148|NCT00557544|"~     This is a Randomized double blind trial with the aim to estimate the effectiveness of 3~     therapeutic regimes per os on migraine pain:~        -  metoclopramide 0,15 mg/kg + placebo~        -  metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg~        -  ketoprofen 1 mg/Kg + placebo~      Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale~     every 20 min.~      The main objective is the evaluation of healing times from pain in the 3 groups~   "
229149|NCT00557531|"~     This is a Phase I, multi-center, open label study designed to assess the safety and~     feasibility of the injectable BL-1040 implant to provide scaffolding to infarcted myocardial~     tissue.~   "
229150|NCT00557518|"~     Based upon the preclinical evidence in models of diabetic nephropathy under conditions~     approximating both type I and II diabetes, treatment with alagebrium appears to have~     favorable and advantageous effects on the biochemical, structural, pathological and~     functional hallmarks of diabetic nephropathy. The renoprotective effects of alagebrium in~     preclinical models favor the evaluation of this drug in patients with type I diabetes.~   "
229151|NCT00557505|"~     P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits~     P-cadherin. This study will test how well the drug is tolerated, and what effects there might~     be. Blood will also be taken to measure the amount of drug in blood.~   "
229152|NCT00557492|"~     This study is to determine the efficacy of bevacizumab and gemcitabine in combination with~     radiation therapy in the preoperative treatment of potentially-resectable subjects with~     pancreatic cancer.~   "
229153|NCT00557466|"~     This study will evaluate the dose response relationship among four doses of indacaterol as~     well as placebo delivered via the TWISTHALER® device.~   "
229154|NCT00557453|"~     The treatment of acute cholecystitis includes limited oral intake, antibiotics and early or~     delayed surgery. To date there are no randomized trials proving the benefit of antibiotic~     treatment.~      The aim of this study is to prospectively and randomly compare between patients that are~     admitted for acute cholecystitis and treated with or without antibiotics.~   "
229155|NCT00557440|"~     This study is designed to provide data about the 24 hours FEV1 profile, safety and~     tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using~     fluticasone/salmeterol as an active control.~   "
229156|NCT00557427|"~     The study is a pilot study where adolescents 12 - 18 years of age with mild to moderate~     depression will be randomized to receive either hypericum 250mg twice daily or fluoxetine~     10mg daily increased to 20mg daily after 1 week and the option to increase to 40mg daily~     after 4 weeks. Patients will be treated for a total of 8 weeks. Efficacy will be measured~     using the CDRS-R, BDI-II and the CGI scales. Safety parameters include blood tests,~     urinalysis and ECG.~   "
229157|NCT00557414|"~     The purpose of this study is to determine the impact of the serum soluble triggering receptor~     expressed on myeloid cells-1 (sTREM-1) on etiology and prognosis of acute respiratory~     distress syndrome (ARDS)~   "
246413|NCT00327808|"~     The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic~     smoker subjects.~   "
229159|NCT00557388|"~     Aging is associated with the loss of lean muscle mass, termed sarcopenia. Food intake and in~     particular the ingestion of protein or amino acids has been shown to be a powerful stimulus~     to promote net muscle protein anabolism. However this anabolic response following a meal-like~     protein bolus seems to be blunted in the elderly as compared to young adults.~      The first aim of this proposal is to investigate the post-prandial muscle protein synthesis~     rates in young and elderly men in response to a meal-like protein bolus after a period of~     rest or physical activity (study A). The rest trial (REST) will act as a proof-of-principle~     study to examine the blunted protein synthetic response in the elderly, and as a control~     trial in comparison with the exercise trial (EXC) to establish the surplus value of physical~     activity prior to protein intake on muscle protein synthesis.~      The second aim of this proposal is to determine the surplus value of an increased quantity of~     the ingested protein bolus (study B). Large amounts of protein (40 and 60 g) will be compared~     to a meal-like amount of protein (20 g) as a means to maximize plasma amino acid availability~     and/or to stimulate muscle protein anabolism.~      The third aim of this proposal is to study the differences in quality of the ingested protein~     bolus (study C). Instead of significantly increasing the quantity of the protein bolus, we~     will also apply a more practical approach to augment skeletal muscle protein synthesis rates;~     modifying the digestibility or amino acid composition of a meal-like protein bolus.~   "
229160|NCT00557375|"~     Patients with recent diagnosis and treatment of a brain tumor will complete a short~     questionnaire concerning the patient's quality of life and emotional state since receiving~     treatment. Caregivers will complete a one-page questionnaire concerning the patient's quality~     of life and emotional state since receiving treatment.~   "
229161|NCT00557362|"~     We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal~     keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study~     to investigate the safety and feasibility of conducting a larger study and to generate~     preliminary data.~   "
229162|NCT00557349|"~     This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or~     Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer~     after gastric bypass surgery.~   "
229163|NCT00557336|"~     This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height~     gain during 12 months of growth hormone treatment in children born small for gestational age~     due to intrauterine growth retardation.~   "
229164|NCT00557323|"~     Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate~     (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia,~     including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being~     observed for any bone adverse events or other serious adverse events, as well as the~     collection of mortality data.~   "
229165|NCT00557310|"~     The purpose of this study is to use imaging technologies to demonstrate the effects of~     teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women~     with osteoporosis.~   "
229166|NCT00557297|"~     The aim of this non-interventional study is to ensure that patients in routine clinical~     practice follow given treatment instructions and to evaluate the number of reliever~     inhalations as well as the number of patient/days with more than 8/12 total inhalations at~     any day. If the number of reliever inhalations and thus the received inhaled~     glucocorticosteroid dose is not excessive, the safety conclusions from the clinical studies~     can be extrapolated to real life for better acceptance of SMART (Symbicort Maintenance and~     Reliever Therapy).~   "
229167|NCT00557284|"~     AD is a disease found in children; the focus of the study is the mechanisms associated in~     children with AD induced by food allergies.~      This study will be a randomized, double-blind, placebo-controlled, parallel group trial~     conducted in participants diagnosed with atopic dermatitis and food allergies. The study~     duration for participants will be approximately 9 weeks. A total of 20 participants will be~     recruited for the entire study. Each arm will consist of 10 participants.The study will~     enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated~     with food allergens, previously documented by skin or RAST test, before enrollment. Atopic~     dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the~     study.~   "
229168|NCT00557258|"~     The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care~     practices in Germany. The study will be conducted on a fixed day in November 2007.~      Primary care surgeries throughout Germany will be asked to take part. The study material will~     be delivered to the surgery by a member of sales-force who will also explain the study~     conduct to the physician/staff. Physicians who want to take part in the study will send a~     signed contract to BI. Physicians will be trained to diagnose RLS.~      All patients attending the participating surgeries on a fixed day will be invited to~     participate in the study. The patients will be handed a questionnaire to fill out while~     waiting for their appointment. No patient-related data apart from gender and year of birth~     will be recorded on the questionnaire and it will be ensured that no re-identification of~     patients is possible. Therefore, no written informed consent will be obtained from the~     participants.~      The patient questionnaire will consist of the following items:~      A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file)~     Additional questions concerning the impact of the patients leg problems on daily life.~      The practice staff will then collect the questionnaire. All patients who have answered~     question 1 (asking for unpleasant sensations of the legs) with ¿Yes¿ will subsequently be~     assessed for the diagnosis by the physician.~      The physician fills out a second questionnaire, covering the following items:~      Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of RLS~     was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed~     questionnaires will be sent to data management by the surgery within 2 working days.~   "
229169|NCT00557245|"~     Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis~     decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant~     couples.~   "
229170|NCT00557232|"~     Bevacizumab (Avastin®, Roche, Rio de Janeiro, Brazil) is an anti-VEGF recombinant humanized~     monoclonal IgG1 antibody used to treat colorectal cancers. Bevacizumab may have a role in~     treating ocular disorders involving fibrovascular proliferation. To determine whether~     intraocular bevacizumab decreases rubeosis iridis in patients with neovascular glaucoma.~   "
229171|NCT00557219|"~     The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney~     function preservation in patients at high risk for renal failure after cardiac surgery.~     Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery.~     Some of them require renal replacement therapy and despite that mortality in this group~     exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may~     decrease the rate of severe renal failure.~   "
229172|NCT00557206|"~     Patient receiving oxaliplatin and docetaxel will have longer progression free survival than~     those patients receiving standard care.~   "
229173|NCT00557193|"~     This phase III trial studies combination chemotherapy with or without lestaurtinib with to~     see how well they work in treating younger patients with newly diagnosed acute lymphoblastic~     leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether combination chemotherapy is more~     effective with or without lestaurtinib in treating acute lymphoblastic leukemia.~   "
229174|NCT00557180|"~     Asthma is a common, long-term disease that is caused by inflammation of the airways.~     Inflammation also plays a role in obesity and may affect the way a person responds to asthma~     medication. This study will examine the relationship between obesity and inflammation and the~     effect they have on response to corticosteroid asthma medications.~   "
229175|NCT00557154|"~     The purpose of this study is to learn how the use of ultrasound helps with the placement of~     an intravenous (i.v.) catheter in young children.~   "
229176|NCT00557141|"~     In a private practice setting typical for ambulatory medicine in Germany, asthma staging~     according to the GINA guidelines will be correlated with real life treatment and self~     management of adult outpatients suffering from asthma. Attitudes concerning adherence,~     awareness, interest in shared decision making and knowledge about the disease are assessed.~   "
229177|NCT00557128|"~     This is a randomized, open-label, single-dose, period-balanced, three-period crossover study~     conducted in healthy subjects designed to evaluate whether the absorption of the FDC~     formulation is affected by the ingestion of a high fat meal or is altered when taken in a~     fasted state.~   "
229178|NCT00557115|"~     The principal aim of the study is to evaluate whether attendance at an exercise training and~     education programme (known as pulmonary rehabilitation) shortly following hospital discharge~     can lead to a reduction in exacerbations and improvement in exercise capacity and quality of~     life in patients with chronic obstructive pulmonary disease.~   "
229179|NCT00557102|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving cetuximab~     together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination~     chemotherapy works as first-line therapy in treating patients with colorectal cancer that has~     spread to the liver and/or lung.~   "
229180|NCT00557089|"~     This study will assess whether rhDNase treatment improves ventilation inhomogeneity as~     assessed by lung clearance index (LCI) in patients with cystic fibrosis (CF).~   "
229181|NCT00557076|"~     The purpose of the study is to determine whether familiar vocal stimulation, provided during~     coma recovery, improves outcomes for persons who are unconscious after severe TBI. The~     primary hypothesis is that unconscious persons who receive standard rehabilitation (SR) plus~     a high-dose of Familiar Voice stimulation (FVs) compared to unconscious persons who receive~     SR plus a sham stimulation (Sham Group) will demonstrate:~        1. Significantly more neurobehavioral functioning post-intervention compared to~          pre-intervention.~        2. Using Functional Magnetic Resonance Imaging (fMRI), significantly higher average~          measures of volumetric activity in the whole brain, middle temporal gyrus bilaterally,~          primary auditory area, bilateral pre-frontal cortex, hippocampus and/or the cerebellum~          post-intervention compared to pre-intervention.~   "
229182|NCT00557050|"~     A common soft tissue injury in sports involving sprinting and jumping is the hamstring~     strain.~      Not much evidence-based research has been carried out on prevention of hamstring strains.~      Most studies suggest that hamstring strains occur during the later part of the swing phase~     when the player is sprinting. In this phase the hamstring muscles are working to decelerate~     knee extension - that is, the muscle develops tension while lengthening. This means that the~     muscles change from functioning eccentrically to concentrically. We hypothesize that it is~     during this rapid change from eccentric to concentric function that the muscles are most~     vulnerable to injuries, and that the injuries can be prevented by increasing the eccentric~     muscle strength in the hamstring.~      This randomized clinical trial will examine the effect of a 10-week preseason~     strength-training program in Danish elite soccer. The strength-training program focuses on~     eccentric hamstring training.~      60 elite teams (1200 soccer players) will be cluster-randomized to either ordinary training~     or ordinary training combined with eccentric hamstring strength training. The training group~     will start the training program in the pre-season (10 weeks) and continue the training once a~     week during the following season.~      Suspected hamstrings strains during the season will be examined within 3 days using~     ultrasound. Ultrasound verified hamstring strains will be registered, and players will start~     a standardized rehabilitation program.~   "
229183|NCT00557037|"~     Two groups of patients with prostate cancer will be enrolled:~      Group A: patients whose cancer has worsened or spread after being on hormonal therapy and has~     not had any chemotherapy.~      Group B: patients who have a rising PSA after surgery or radiotherapy for the prostate and do~     not have any spread to the bones or other organs.~      Patients will receive Phenoxodiol (PXD) 400 mg every 8 hours daily for 28 consecutive days (1~     cycle). Treatment outcome will be evaluated after three cycles (12 weeks) of PXD treatment~     (immediately prior to cycle 4). Patients with progression of disease will be taken off study.~     Responding and stable disease patients will remain on study for a total of 12~     cycles(approximately 12 months).~   "
229274|NCT00555776|"~     The purpose of this study is to determine wether Gabapentin which is useful for treating~     neuropathic pains, is effective on idiopathic subjective tinnitus.~   "
229189|NCT00556946|"~     This research study was designed to determine the effect on port wine stains (PWS) of~     liposomal benzoporphyrin derivative monoacid (BPD-MA) termed verteporfin by intravenous (IV)~     infusion for photodynamic therapy (PDT) or combined PDT and pulsed dye laser (PDL) therapy~     (PDT + PDL). The standard treatment for PWS is PDL alone. This lightens some PWS but many~     lesions are not completely removed.~      PDT uses a medication and light together to cause injury to a target. The medication is given~     and then light is directed at the desired area of treatment to achieve an effect. PDT has~     been used to treat some skin conditions including pre-cancers and skin cancers. Using PDT or~     PDT immediately followed by PDL therapy may improve PWS lightening. At this time, both PDT~     and PDT + PDL therapy for treatment of PWS is investigational. The type and amount of~     medication and light which may be used to treat PWS is not known, and is likely to be~     different than those used for other PDT treatments.~   "
229190|NCT00556933|"~     This 2 x 2 sequential factorial study evaluates two potential improvements to the standard~     immunosuppression regimen used at the investigators' institution to prevent rejection of~     transplanted kidneys. These two potential improvements are each applied in sequence to half~     of the study patients, creating 4 study arms; the other half receive the standard treatment.~     The two potential improvements are:~        1. Administering the immunosuppression induction agent rATG (rabbit anti-thymocyte~          globulin) in a single dose at the time of transplantation, instead of in the usual~          series of 4 smaller doses over 6 days.~        2. After 6 months, modifying the maintenance immunosuppression used to prevent rejection by~          replacing the drug tacrolimus with mycophenolate mofetil (MMF).~      The two interventions, spaced sequentially six months apart, enable independent analysis of~     the two treatments so long as it can be shown that there is no synergistic interaction~     between them.~   "
229191|NCT00556920|"~     This study will be a randomized study investigating the bioequivalence of COREG CR and~     Lisinopril to COREG CR and ZESTRIL~   "
229192|NCT00556907|"~     We hypothesize that the combination of mammography and CE-MRI will improve the surgeon and~     radiologist's ability to define extent of disease prior to surgical resection, improve the~     odds of obtaining clear surgical margins, and increase the efficacy of IORT delivered~     immediately after initial surgical resection. In this investigation, we will determine~     whether or not patients deemed eligible for 'immediate IORT based on mammography and CE-MRI~     can be successfully treated without the need for re-excision or additional radiotherapy due~     to inadequate surgical margins.~   "
229193|NCT00556894|"~     This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory~     agent, will improve the clinical condition of patients with rheumatoid arthritis who still~     have active joint inflammation despite taking methotrexate for at least 6 months.~   "
229194|NCT00556868|"~     Breakfast is often labelled the most important meal of the day.~      Parents and teachers quite often stress its importance for successful learning during the~     morning hours. With declining numbers of children and especially adolescents eating breakfast~     regularly, the study examines the influence of breakfast consumption on cognition and mood of~     high school students.~   "
229195|NCT00556855|"~     The objective of this study is to evaluate the topical E-DO in patients with Chronic Hand~     Dermatitis (fu kuei shou).~   "
229196|NCT00556842|"~     Each year, hip fracture, an injury that can impair independence and quality of life, occurs~     in about 280,000 Americans and 36,000 Canadians. By the year 2040, the annual healthcare~     costs associated with hip fractures are expected to reach $9.8 billion in the United States~     and $650 million in Canada. It is important to have in place optimal practice guidelines for~     the surgical handling of this injury. One type of hip fracture, called a displaced femoral~     neck fracture, is often treated with a hip replacement surgery. Patients undergoing a hip~     replacement may receive either a total hip replacement, in which the head of the femur and~     the hip joint socket are replaced, or a partial hip replacement, in which only the head of~     the femur is replaced. This study will compare the two different hip replacement procedures~     to determine which one results in better outcomes after surgery in adults aged 50 and older.~   "
229197|NCT00556816|"~     COPD (chronic obstructive pulmonary disease) is a chronic disease which is increasing.~     Patients with COPD are the most important concern of the pulmonologists. At the outpatient~     clinic has been observed that the amount of new and regular COPD patients is of such a size~     that it seems to overwhelm the capacity of the outpatient clinic. Solutions could be~     substitution of medical care, longer intervals between the appointments or discharge from~     secondary medical care to primary care. The first point does not solve the lack of capacity,~     the second point is not allowed because it will decrease quality of care and transition of~     care is a temporary solution. COPD is a complex disease, whereby, and certainly in an~     advanced stadium, multidisciplinary and qualified expertise is needed.~      The optimal control frequency of patients with COPD is unknown. COPD is a disease with~     fluctuating activity and complaints over time. There is a chance that patients are seen at a~     stable state at the regular outpatient clinical visits instead of moments when medical care~     is obligated. The regular management of the outpatient clinic will therefore result in an~     ineffective treatment of COPD patients. In this way general practitioners and even patients~     could suggest that visits to the outpatient pulmonary clinic are confounding less to a good~     treatment of COPD.~      Outpatient clinical care on demand, initiated by patients in other chronic patient groups~     like rheumatoid arthritis and inflammatory bowel diseases, are proven to be safe and~     effective leading to less consumption and costs of medical care in comparison to standard~     outpatient clinical visits 2-5.~      The outpatient clinical care on demand for COPD is not figured out yet. Our aim is to~     investigate whether this special type of outpatient clinical care is effective in the~     management of COPD.~   "
229198|NCT00556803|"~     The purpose of this study is to prospectively evaluate whether transcatheter arterial~     chemoembolization (TACE) will improve the outcome of radiofrequency ablation for~     hepatocellular carcinoma (HCC) or not.~   "
229199|NCT00556790|"~     To investigate the real value of a fast track protocol compared to a standard care protocol~     regarding postoperative complications and hospital stay in a multicentric setting in an~     intention to treat fashion.~   "
229200|NCT00556777|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     intraoperative radiation therapy may reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery~     works in treating older women with stage I breast cancer.~   "
229201|NCT00556764|"~     The main objectives of this protocol are as follows:~        1. To assess the sensitivity and specificity of ANAM-PD in detecting cognitive status in~          patients with Parkinson disease (PD) and healthy controls (HC).~        2. To validate the specific individual domains of the ANAM-PD cognitive battery by~          comparisons to available standardized cognitive evaluation scales administered to the~          patients with Parkinson disease with and healthy control subjects.~        3. To evaluate the reliability of the ANAM-PD battery of tests by comparing repeated~          administrations of the ANAM-PD battery on a sub-set of subjects with Parkinson disease~          and healthy controls.~        4. To characterize cholinergic neurotransmission through imaging the vesicular~          acetylcholine transporter binding with 123Iodobenzovesamicol (IBVM) and SPECT in PD~          patients and healthy controls.~   "
229202|NCT00556751|"~     An electrocardiogram (ECG) is a test that evaluates the electrical activity of the heart and~     can be used to detect heart problems. By analyzing ECGs collected over a 20-year period, this~     study will examine ECG abnormalities and the differences in ECG findings between black and~     white people, from young adulthood through middle age.~   "
229203|NCT00556738|"~     During caesarean section, transient respiratory distress which occurs frequently (3%) with~     possible complications are at present managed by non invasive nasal continuous positive~     airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive~     Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to~     treat some respiratory distress syndrome of the newborn with a good tolerance, but without~     evaluation in prospective studies~   "
229204|NCT00556712|"~     This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva,~     compared with placebo, following platinum-based chemotherapy in patients with advanced,~     recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity~     during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients~     will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The~     anticipated time on study treatment is until disease progression; the target sample size is~     500+ individuals.~   "
229205|NCT00556699|"~     This is an open-label, multicenter Phase Ib study designed to evaluate the safety,~     pharmacokinetics, and preliminary efficacy of SGN-40 when combined with rituximab in patients~     with relapsed CD20-positive, follicular or marginal zone NHL who have received at least one~     prior rituximab-containing regimen.~   "
229206|NCT00556686|"~     The purpose of this study is to examine how compounds produced in patients with canker sores~     affect wound healing.~   "
229207|NCT00556673|"~     This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500~     μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent~     asthma.~   "
229208|NCT00556660|"~     The main objectives of this proposal are as follows:~      To assess the dynamic uptake and washout of 123-I AV51, a potential imaging biomarker for~     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in~     similarly aged healthy controls and Alzheimer's (AD) subjects~      To perform blood metabolite characterization of 123-I AV51 in healthy and AD subjects to~     determine the metabolic fate and nature of metabolites in assessment of 123-I AV51 as a~     single photon computed tomography (SPECT) brain imaging agent~      Evaluate the test/retest reproducibility of 123-I AV51 and SPECT in AD subjects and healthy~     controls~   "
229209|NCT00556647|"~     Patients who are admitted to the outpatient pulmonology department by a general practitioner~     or specialist with a chest X-ray suspicious for lung cancer with an age between 18 and 80~     years are suitable for participation. The X-ray and referral are studied by a chest physician~     (by phone or fax ). Selected patients are invited to enter the study after answering a~     questionnaire by phone (p. 31). The questionnaire screens patients' interest, co-morbidity~     and medication use. Informed consent forms, patient information forms and a time table for~     the diagnostic day are provided by mail or E-mail in cases where time gets short. Waiting~     time to enter the study will be no longer than one week.~      Hundred patients will be recruited by means of informed consent. Patients will be admitted at~     the pulmonary ward for the study day and will be accompanied by nurses. All patients will get~     PET-CT scanning in the morning of the study day. Depending on the location of lesions seen on~     PET-CT, further invasive diagnostic procedures will be planned for the afternoon.~      Mediastinal and adjacent structures will be analysed with EUS-FNA. Mediastinal staging will~     be done with bronchoscopy alone for central located tumors, peripherally located lesions will~     be analysed with EUS-FNA or bronchoscopy.~      The percentage of patients in which this diagnostic track leads to a diagnosis and tumor~     stage in one day will be determined. The number of tests and diagnostic procedures needed to~     obtain a diagnosis, including tumor stage (especially final stage NSCLC) and function tests,~     will be compared with a historical matched study group. This historical study group is chosen~     from an era before the availability of integrated PET-CT and ultrasound guided endoscopic~     tools and meets the same inclusion and exclusion criteria as the patients in this study. The~     timelines from initial chest X-ray to diagnostic day to informing the patient to start of~     treatment will be determined. These figures will be compared with the historical study group.~   "
229210|NCT00556634|"~     Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of~     subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.~      Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV~     given as a stepped dosage over 2 weeks versus the usual dosage.~      Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage~     (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was~     compared with conventional administration (arm B: 600 mg qd from the first day). All patients~     received additional treatment with 2 NRTIs.~      The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type~     scale specifically designed. Efficacy was assessed by percent of virological failures.~   "
229211|NCT00556621|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination~     chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when~     given together with cisplatin and radiation therapy and to see how well they work in treating~     patients with stage II or stage III bladder cancer.~   "
229212|NCT00556608|"~     The purpose of this study is to prove the non-inferiority of the intra-articular injection of~     hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to~     Synvisc®.~   "
229213|NCT00556595|"~     Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in~     paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of~     possible electrical gaps versus primary electrophysiological ablation at the sites of~     atrio-venous electrical breakthroughs with secondary circumferential ablation around the~     pulmonary vein orifice~   "
229216|NCT00556530|"~     22q11.2 deletion syndrome is a genetic disorder that can cause heart defects, facial~     abnormalities, and developmental and learning disabilities. The severity of the disorder can~     vary widely among people. This study will analyze DNA from people with 22q11.2 deletion~     syndrome to identify genetic variations that may affect the severity of the disorder.~   "
229217|NCT00556517|"~     A common soft tissue injury in sports involving sprinting and jumping is the hamstring~     strain. In addition to the frequency of injury, hamstring injuries are also the most~     recurrent soft tissue injury occurring in sport. There is a need for further research~     concerning diagnosis and different prognostic parameters for the rehabilitating process.~      The aims for this study are:~      A longitudinal comparison of sonographic and MRI assessments of acute and healing hamstring~     injuries.~      A study investigating different biomechanical parameters in the process of determining~     whether a former hamstring injured soccer player is fully rehabilitated. We hypothesize that~     it is possible to use electromyography, muscle strength measurements and different tests on a~     force platform to help determine this issue.~   "
229218|NCT00556504|"~     The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on~     treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients~     with genotype 1 chronic hepatitis C infections. This will be demonstrated by a higher~     sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks~     after the termination of combinational drug treatment, compared with the placebo add-on.~   "
229219|NCT00556491|"~     This study proposes to investigate whether treatment with minocycline pre-operatively in~     patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce~     the occurence of kidney injury.~   "
229220|NCT00556478|"~     The purpose of this study is to evaluate the effectiveness, safety and tolerability of the~     investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug,~     PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic~     (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be~     applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an~     attempt to delay ejaculation.~   "
229221|NCT00556465|"~     Diabetic nephropathy has become the single most frequent cause of end-stage renal disease.~      On a molecular level, at least five major pathways have been implicated in glucose-mediated~     vascular and renal damage and all of these could reflect a single hyperglycaemia-induced~     process of overproduction of reactive oxygen species.~      Recent studies have shown that inflammation, and more specifically pro-inflammatory cytokines~     play a determinant role in the development of micro- vascular diabetic complications, most of~     the attention has been focused on the implications of TNF-α in the setting of diabetic~     nephropathy.~      Glutathione is the most abundant low-molecular-weight thiol, and Glutathione/ glutathione~     disulfide is the major redox couple in animal cells.~      N-acetylcysteine is effective precursors of cysteine for tissue Glutathione synthesis.~      Not only does N-acetylcysteine exhibit antioxidant properties, but it may also counteract the~     glycation cascade through the inhibition of oxidation.~      N-acetylcysteine can also reduce the apoptosis elicited by reactive oxygen species .~      Indeed, N-acetylcysteine has been shown to inhibit reactive oxygen species induced mesangial~     apoptosis and to be able to protect cells from glucose-induced inhibition of proliferation.~   "
229222|NCT00556452|"~     The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with~     Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then~     (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for~     stem cell transplant in the treatment of aggressive hematologic malignancies in subjects~     where more conventional approaches are failing.~   "
229223|NCT00556439|"~     Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of~     the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the~     largest blood vessel in the body, and its branches. Therapies are available to improve the~     symptoms of GCA and TAK, but relapse often occurs, and better treatments are needed.~     Abatacept is a drug that interacts with certain cells in the body that are involved with GCA~     and TAK. This study will evaluate the effectiveness of abatacept in treating GCA and TAK and~     preventing disease relapse.~   "
229224|NCT00556426|"~     This study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter~     System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in~     patients with pulmonary thromboembolism.~   "
229225|NCT00556413|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving cetuximab together with combination chemotherapy may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination~     chemotherapy works as first-line therapy in treating patients with metastatic colorectal~     cancer.~   "
229226|NCT00556400|"~     This study will explore the role of oral contraceptive pills in managing uterine bleeding in~     women who have low blood platelet counts as a result of aplastic anemia. Oral contraceptive~     pills have been shown to be effective in managing uterine bleeding in healthy women, but the~     effects have not been thoroughly studied in women who have low platelet counts. The purpose~     of the study is to determine whether oral contraceptive pills are a useful complement to~     platelet transfusions in women with aplastic anemia and uterine bleeding.~      Volunteers for this study must be women between 12 and 55 years of age who have been~     diagnosed with aplastic anemia (with a platelet count of less than 50,000/microliter) and~     currently have active uterine bleeding. Candidates must not be pregnant or breastfeeding,~     must have a uterus and at least one functioning ovary, and must be willing to use nonhormonal~     methods of birth control (such as condoms or a diaphragm) for the duration of the study. On~     the first visit, candidates will be screened with a complete medical history (including~     obstetric and gynecological history) and will undergo a physical examination, a pelvic exam~     and a pelvic ultrasound. Blood and urine samples will also be taken on this first visit.~      The study will last approximately two weeks. Participants will be asked to monitor their~     medication doses and severity of bleeding during the course of the study. After the first~     visit, participants will be separated into two randomized groups and will receive either one~     tablet of oral contraceptive or a placebo twice daily, to be taken 12 hours apart at the same~     times each day. Participants will also receive platelet transfusions as needed to ensure that~     their platelet counts remain over 20,000/microliter. After seven days, researchers will~     assess participants' uterine bleeding and all participants will be given oral contraceptives~     in the second week of the study. Participants whose bleeding has decreased will receive only~     one tablet; participants who still have moderate to severe uterine bleeding will receive two~     tablets. A final assessment will be performed on day 14 of the study.~   "
229227|NCT00556387|"~     The purpose of this study is to determine the possible effects of an anesthetic agent called~     Ketamine on the injured brain in children.~      The researchers think that it will effect the outcomes of children with these injuries.~   "
229228|NCT00556374|"~     The purpose of this study is to determine whether denosumab compared to placebo, will reduce~     the rate of first clinical fracture in women with non-metastatic breast cancer receiving~     (non-steroidal) aromatase inhibitor therapy.~      Subjects who receive open-label denosumab will be followed-up until completion of 36 months~     of treatment. Subject not receiving treatment in the open label phase will be followed for~     approximately 66 months after Primary analysis data cut-off date (PADCD).~   "
229229|NCT00556361|"~     To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury~     to the cells in the brain.~   "
229230|NCT00556348|"~     To report the short term anatomic and visual acuity response after intravitreal injection of~     bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal~     neovascularization secondary to age-related macular degeneration.~   "
229231|NCT00556335|"~     The purpose of this study is to evaluate the efficacy of manual aspiration in comparison to~     conventional chest tube drainage in pneumothorax therapy:~        1. whether manual aspiration will shorten hospital admission.~        2. whether the lung will expand by means of clinical and radiological findings.~   "
229232|NCT00556322|"~     This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that~     of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC~     experiencing disease progression after failure of platinum-based chemotherapy.Eligible~     patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either~     Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on~     study treatment is until disease progression ,and the target sample size is 500+ individuals.~   "
229233|NCT00556309|"~     The purpose of this study is to identify the healing of aneurysms in three month use Optical~     Coherence Tomography image to measure outcomes in post coiled aneurysms. Endovascular~     therapeutic coiling is a widely used procedure in the management of aneurysms, which is an~     angiogram .~   "
229234|NCT00556296|"~     This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose~     of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with~     ADHD.~   "
229235|NCT00556283|"~     This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled~     Transanal Rectal Resection (STARR) compared to biofeedback training in patients with~     obstructed defecation syndrome (ODS).~   "
229236|NCT00556270|"~     The aim of the study is to evaluate the efficacy and safety of matrifen in patients with~     severe and chronic pain who can only be sufficiently treated with opioid analgesics (WHO~     class 3).~   "
229237|NCT00556257|"~     A new immunosuppressive drug based on the inhibition of an important enzyme in the immune~     system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this~     research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant~     patients for 12 months in addition to other standard transplant medications such as~     prednisone.~   "
229238|NCT00556244|"~     Internal limiting membrane peeling in diabetic vitrectomy will help prevent postoperative~     epiretinal membrane formation~   "
229239|NCT00556231|"~     Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and~     improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care~     Unit (PICU) stays. NIRS estimates the amount of oxygen in tissues by comparing the tissue's~     absorption of two wavelengths of light corresponding to hemoglobin carrying oxygen and~     hemoglobin without oxygen.~      During cardiac surgery, multi-site NIRS monitoring is used to determine the heart's output by~     comparing the amount of oxygen available to discrete regions of the body nourished by~     different parts of the circulatory system. NIRS leads placed on the forehead detect oxygen~     available to the brain (cerebral), while leads placed over the kidney reflect oxygen~     available to the internal organs (somatic).~      NIRS monitoring has been used for studying muscle oxygen usage during exercise in normal and~     disease states. Cerebral oxygenation at peak exercise at has been studied with NIRS~     monitoring. The use of multi-site NIRS monitoring during exercise stress testing for studying~     cardiac output through the patterning of somatic and cerebral oxygenation in combination with~     exercise stress test data has not been researched.~      We hypothesize that addition of multi-site NIRS monitoring to the standard data collection~     already achieved during exercise testing, will enable calculation of anaerobic threshold and~     cardiac output prediction. This will assist in determining appropriate timing for surgical~     intervention, predicting the post operative course and testing response to medication.~   "
229240|NCT00556218|"~     The goal of this behavioral research study is to learn if participating in a Tibetan~     meditation program helps to improve quality of life for women after chemotherapy and during~     recovery from breast cancer. Whether the meditation program helps to improve brain function~     and sleep quality will also be studied.~   "
229241|NCT00556205|"~     The purpose of this research study is to further define an effective strategy for people with~     renal cell carcinoma and to learn the safety and effectiveness of two different types of~     sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and~     bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard~     treatments for advanced renal cell carcinoma. However, some people who receive this treatment~     do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA~     approved drug used for the treatment of several cancers however, is not yet approved for use~     in renal cell carcinoma.~   "
229242|NCT00556192|"~     This prospective randomized control trial is undertaken to evaluate the safety and efficacy~     of anti-CD20 monoclonal antibody, rituximab, used as 1. monotherapy, 2. in combination with~     cyclophosphamide, in the treatment of proliferative lupus nephritis, as compared with~     standard immunosuppressive therapy with cyclophosphamide and azathioprine.~   "
229243|NCT00556179|"~     The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence~     of bacterial vaginosis after three months of the standard treatment.~   "
229261|NCT00555945|"~     The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus~     sliding hip screws on rate of revision surgery in individuals with inter-trochanteric~     fractures. Secondary outcomes include fracture healing rates, fracture related complications,~     and health-related quality of life.~   "
230739|NCT00536289|"~     The hypothesis for this study is that use of blunt tipped needles used during the repair of~     an episiotomy (tear in the vagina after childbirth) will result in fewer needlestick injuries~     to the surgeon.~   "
229244|NCT00556166|"~     Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of~     patients with long term, uncontrolled (not helped by medication) nausea and vomiting from~     gastroparesis of diabetic or idiopathic origin.~      In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device~     Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical~     (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy~     System probably helps patients, symptoms, the FDA's HDE approval indicates that the~     helpfulness of this therapy has not been proven. Physicians at Columbia University Medical~     Center hope to prove the helpfulness of this device.~   "
229245|NCT00556153|"~     The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in~     pediatric brain tumors when compared to normal brain tissue.~   "
229246|NCT00556140|"~     The purpose of the study is to assess the safety and effectiveness of the combination of~     aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with~     psychotic major depression.~   "
229247|NCT00556127|"~     The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to~     dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT)~     as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI~     score~   "
229248|NCT00556114|"~     Growing evidence shows that altered blood flow plays a major role in many vision-threatening~     diseases including glaucoma, diabetic retinopathy, age-related macular degeneration, Central~     Retinal Vein Occlusion, and Branch Retinal Vein Occlusion. Optical coherence tomography, an~     established imaging technique use for eye exam in clinical ophthalmology, provides~     high-resolution cross sectional images of the retina and has increased our ability to~     understand many eye diseases.~   "
229249|NCT00556101|"~     Investigation of how the patients experience whole body MRA. After the WB-MRA the patients~     will fill in a questionnaire, that contains questions about the WB-MRA procedure and how the~     patient felt during the examination.~      We expect that the patients will report a high degree of satisfaction with the WB-MRA~     procedure, with little discomfort.~   "
229250|NCT00556088|"~     This phase I protocol will evaluate the safety and tolerability of the combination of LBH589~     and paclitaxel/carboplatin. The combination of LBH589, paclitaxel/carboplatin, and~     bevacizumab will also be evaluated for tolerability and preliminary antitumor activity in a~     subset of patients with advanced non-small cell lung cancer.~   "
229251|NCT00556075|"~     The purpose of this study is to determine whether Proellex is safe and effective for the~     treatment of symptomatic endometriosis.~   "
229252|NCT00556062|"~     To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split~     influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial~     was conducted in 560 subjects in Tianjin City of China.~   "
229253|NCT00556049|"~     The purpose of this research study is to determine if the combination of sunitinib and~     gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The~     safety of this combination will also be studied. Sunitinib is approved by the FDA for the~     treatment of renal cell carcinoma. However, some patients' cancers do not respond to~     treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug~     that is approved by the FDA for the treatment of pancreatic cancer and several other cancers.~     It is not approved for the treatment of renal cell carcinoma. Previous research has suggested~     that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic~     renal cell carcinoma.~   "
229254|NCT00556036|"~     The purpose of this study is to determine whether the hormone dynamics in women with anorexia~     nervosa and hypothalamic amenorrhea is related to bone loss in those populations.~   "
229255|NCT00556023|"~     The purpose of this study is to determine the safety and tolerability of different doses of~     CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206~     that is well tolerated when given in combination with gemcitabine to patients with advanced~     pancreatic cancer.~   "
229256|NCT00556010|"~     Ankle fractures are common injuries that are being operated routinely. In order to restore~     the long term function and prevent arthritis of the ankle the broken fragments should be put~     in place precisely. Inadequate reduction can result in pain and long term disability.~     Recently, based on MRI studies and clinical studies, a significant number of ankle fractures~     are apparently fixed with less than optimal results. We suggest that the use of a new device~     that enables better three dimensional imaging will improve the quality of operations~     performed for ankle fractures.~   "
229257|NCT00555997|"~     This is a study on the effectiveness, tolerability and safety of oral ziprasidone as~     monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD~     will be treated with either ziprasidone or placebo for 12 weeks.~      Hypothesis: There will be a statistically significant difference in the magnitude of~     response, as measured by a decrease in baseline 17-item Hamilton Depression Rating Scale~     (HAM-D-17) scores, between the two treatment groups; the reduction in HAM-D-17 scores will be~     greater in the ziprasidone monotherapy group than in the placebo group.~   "
229258|NCT00555984|"~     If the anesthetic regimen can influence the serum level of inflammatory cytokines and if the~     levels of cytokines are related to the incidence of post operative complications, these~     complications may be a function of the anesthetic method. In an effort to find the best~     anesthetic regimen for patients undergoing craniotomy for intracranial tumors, the~     researchers will compare the effect of volatile anesthetic with that of total intravenous~     anesthesia (TIVA) on cytokine levels. The researchers will also compare the composite~     incidence of some common major post-operative complications after craniotomy for intracranial~     malignancy.~   "
229259|NCT00555971|"~     This is a 24 week double-blind study in which subjects will be randomized 2:1 to receive~     Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo.~     Xolair injections will occur every 2-4 weeks. Aspirin desensitization will occur several~     weeks later. One month after desensitization, the final visit will occur in the GCRC.~      We hypothesize that administration of Xolair, a monoclonal anti-IgE antibody, prior to the~     aspirin desensitization will reduce severity of aspirin-induced reaction.~   "
229260|NCT00555958|"~     To determine the safety, efficacy and treatment algorithm(s) of the Maestro System in causing~     weight loss in obese subjects - This study will provide feasibility data regarding the~     potential of intra-abdominal vagus nerve down-regulation/block in the treatment of obesity.~   "
229263|NCT00555919|"~     Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211~     (100 mg vs. 25 mg) as second-line endocrine therapy for postmenopausal women with hormone~     receptor-positive metastatic breast cancer.Once the cancer has spread beyond the lymph nodes~     to areas such as e.g. the skin, soft tissues, lung, and liver it is called metastatic breast~     cancer. Patients who have been diagnosed with metastatic breast cancer that has progressed~     since their previous cancer treatment and that cannot be removed completely by surgery are~     eligible to be treated within this trial.Treatment with a new drug called Progesterone~     Receptor Antagonist ZK 230211 (ZK PRA) targets the progesterone receptor which may be~     expressed on breast cancer tumour cells. Therefore only patients with this progesterone~     receptor on their tumour cells can be included in this study.Progesterone receptor~     antagonists (including onapristone) have already shown efficacy in postmenopausal women with~     advanced breast cancer (Klijn et al. 2000). This phase II study investigates the efficacy~     (proof of concept), safety and tolerability of ZK PRA at two dose levels (25 mg and 100 mg)~     before initiating pivotal phase III trials.~   "
229264|NCT00555906|"~     This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in~     combination with Velcade® [bortezomib] and dexamethasone in patients who have received at~     least one previous treatment for multiple myeloma.~   "
229265|NCT00555893|"~     This study is a randomized, blinded, placebo-controlled clinical efficacy trial to assess the~     duration and severity of influenza symptoms, and duration of viral shedding, in influenza~     patients receiving oseltamivir early and late relative to placebo.~      There are two main hypotheses in this study:~        1. The duration of influenza symptoms, mean severity score, and duration of viral shedding~          are reduced in patients who initiate oseltamivir treatment late (48 to 119 hours)~          compared to those receiving no antiviral therapy.~        2. Prior influenza vaccination (same season) reduces the duration of influenza symptoms and~          mean symptom severity in patients receiving oseltamivir after adjusting for age and~          timing of antiviral therapy (early versus late).~      There are two secondary hypotheses:~        1. The duration of influenza symptoms, mean severity score, and duration of viral shedding~          are reduced in patients with influenza who initiate oseltamivir treatment early (< 48~          hours) versus late (48 to 119 hours).~        2. The incidence of secondary complications is lower in patients initiating oseltamivir~          therapy late relative to those receiving no antiviral therapy.~   "
229266|NCT00555880|"~     The purpose of this clinical study is to evaluate the clinical effect of midodrine~     hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by~     measuring the time to onset of near syncopal symptoms and assessing several cardiovascular~     measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.~   "
229267|NCT00555867|"~     Approximately 60 specialised clinics and 420 office based gynaecologists or oncologists will~     participate in this in practice evaluation program (NIS). The clinic and approximately 7~     office based physicians will collaborate within their breast centre networks to conduct this~     program. A breast centre network should be able to recruit in this program approximately 80~     patients (approximately 40 patients per year). It is planned to enroll approximately 4674~     patients in this NIS (2337 patients per arm). The patient population will include~     postmenopausal women with hormone-receptor positive primary breast cancer scheduled for~     upfront adjuvant endocrine treatment with anastrozole according to the current standard~     medical procedures.~   "
229268|NCT00555854|"~     Diabetes is a common condition associated with increased morbidity and mortality.~     Non-pharmacological intervention strategies focusing on factors to improve self-management~     skills are considered an important part of the treatment in individuals with diabetes.~     Because of the increasing incidence in diabetes with costs (both physical, psychological and~     financial) for both patients and society it is important to investigate interventions that~     successfully promote self-care behaviour in patient with diabetes. Further research is needed~     to develop interventions effective in maintaining long-term glycemic control.~      The aim of this project is to study the long-term effect of a motivational intervention~     program with an individual approach based on cognitive-behavioural strategies in chronically~     ill patients with diabetes. The effect will be evaluated on both physiological and~     psychosocial parameters including patient's experienced self-care competence.~      The study will also provide an overview of what kind of non-pharmacological interventions~     that have been applied in relation to the treatment of type 2 diabetes and assess the effect~     of the various non-pharmacological interventions in randomised controlled trials.~   "
229269|NCT00555841|"~     The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of~     non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant~     radiotherapy.~   "
229270|NCT00555828|"~     Primary Objective The primary objective of this study is to evaluate the safety and~     feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping~     Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of 25 M, 75 M, and~     150 M allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.~      SecondaryObjective~      The secondary objectives are to explore functional efficacy for subsequent study design, as~     well as late-term dose related tolerance, by:~        -  Evaluating the effect of allogeneic MPCs on exploratory efficacy endpoints related to~          cardiac function on Days 90, 180, and 1 year~        -  Evaluating the change from baseline in the Medical Outcome Study Short Form (SF-36),~          Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and the New York~          Heart Association Classification at 30 days, 3 and 6 months, and 1, 2, and 3 years~        -  Evaluating follow-up safety through Day 360~        -  Providing preliminary data to support dose selection for future studies~   "
229271|NCT00555815|"~     Surgical site infections are associated with high morbidity and cost Hypothesis: Extended~     intraoperative hygiene measures decrease surgical site infections in general surgery compared~     to standard hygiene measures.~   "
229272|NCT00555802|"~     The purpose of this study was to evaluate the efficacy of motor control exercises. For this,~     before and after motor control and general exercises, we determined transverses abdominis and~     multifidus thickness, activity limitation and pain. We hypothesized that the motor control~     exercises would increase transverses abdominis and multifidus muscles thickness. Activity~     limitation and pain would decrease following two protocols that it was more in motor control~     group than general one.~   "
230740|NCT00536276|"~     To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.~   "
229275|NCT00555763|"~     The classic Goldmann applanation tonometer has been further developed. The applanation~     principle has been retained, while the internal force transmission and the pressure gauging~     have been optimized, and the display of results digitized.~      The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with~     the new version of the device, and to test the reliability and reproducibility of~     measurements, as well as its safety.~   "
229276|NCT00555750|"~     The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps~     people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S.~     Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in~     the United States as LUNESTA.~      Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that~     can be reversed by two months of eszopiclone for the primary insomnia~   "
229277|NCT00555737|"~     The purpose of this study is to determine how well capsule endoscopy identifies changes in~     the small bowel mucosa of celiac disease patients.~   "
229278|NCT00555724|"~     Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of~     subjects with relapsed or refractory solid tumors.~   "
229279|NCT00555711|"~     We have developed a safe, non-contact, intra-operative guidance system to optimize tumor~     resection in neurosurgery. The Modulated Imaging is non-contact optical imaging technology~     developed at the Beckman Laser Institute, UCI.~      Compared to other imaging approaches, MI has the unique capability of performing both diffuse~     optical tomography and rapid, wide-field quantitative mapping of tissue optical properties~     within a single measurement platform.~      Preliminary in vivo studies have shown that brain tumors, infiltrating tumor margins and~     normal brain may have intrinsically different optical properties.~   "
229280|NCT00555698|"~     The purpose of this investigation is to obtain a preliminary indication of the feasibility,~     safety and efficacy of capsular deep brain stimulation (DBS) as a treatment for intractable~     depression. Also, to to learn about a new treatment for severe depression that has not~     improved enough despite long-term treatment with medications and behavior therapy. The new~     treatment is called deep brain stimulation, or DBS.~      In DBS, thin wires are used to carry electric current to parts of the brain that are thought~     to be involved in producing depression symptoms. Two wires are implanted surgically, and~     attached to battery packs implanted under the skin of the new chest below your collar bone.~   "
229281|NCT00555685|"~     Patients with decompensated heart failure have high rates of mortality and morbidity despite~     recent improvements in diagnosis and treatment. Some aspects of their presentation such as~     renal failure, hyponatremia and congestive phenomena have received special attention, as they~     are associated with worse prognosis. The infusion of hypertonic saline solution has been~     tested in different conditions of cardiovascular collapse. Current evidence indicates that~     the infusion of hypertonic solution in heart failure patients can provide clinical and~     haemodynamic improvement. The investigators are testing the hypothesis that the infusion of~     hypertonic solution in association with diuretics may prevent the occurrence of renal~     dysfunction in patients with decompensated heart failure.~   "
229282|NCT00555672|"~     The purpose of this study is to determine the safe and tolerable dose of sunitinib when given~     together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have~     not received prior chemotherapy for their advanced cancer.~   "
229283|NCT00555659|"~     Introduction: Degenerative changes of the discs and facet joints in the lumbar spine can~     result in pain and disability from spondylosis, spondylolisthesis and stenosis. Patients who~     are suffering with back and/or leg pain are potential candidates for an ALIF procedure.~      Purpose: To assess and compare clinical outcomes and fusion rates in patients undergoing an~     instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic~     categories. Comparisons between type of interbody spacer, graft type, and type of~     instrumentation will also be made~   "
229284|NCT00555646|"~     This is an open label, single center, controlled study with each subject's two treatment~     plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and~     (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no~     treatment and serve as a control.~      Subjects with at least three distinct, stable study plaque areas will receive the~     experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the~     lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission~     is observed in a treatment plaque area then treatment of that area will be discontinued and~     the area assessed weekly. A third plaque area (control plaque area) will receive no drug or~     light treatment and serve as an internal control.~      Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be~     followed for a total of 16 weeks to allow assessment of Durability of Response of treated~     lesions and comprehensive follow-up of adverse events.~   "
229285|NCT00555633|"~     Study aim: To determine the effect of an intensified daily photoprotection over 24 months~     with an SPF30 sunscreen and an after sun-lotion both containing liposomal DNA repair enzymes~     in a population of patients at high-risk for skin cancer, including xeroderma pigmentosum~     (XP) and basal cell nevus syndrome.~   "
229286|NCT00555620|"~     The purpose of the study is to determine the safe and tolerable doses of sunitinib given~     together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients~     who have advanced gastric cancer who have not received prior chemotherapy for their advanced~     cancer~   "
229287|NCT00555607|"~     The aim of the project is to study pathogenetic mechanisms in severe asthma and compare those~     mechanisms in chronic obstructive pulmonary disease (COPD) in order to test the hypothesis~     that severe asthma and COPD develop into similar chronic degenerative changes.~   "
229288|NCT00555594|"~     To determine the effect of subconjunctival Bevacizumab in corneal neovascularization~   "
229312|NCT00555282|"~     The use of these catheters is associated with infectious complications that are an important~     iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface~     modified in order to reduce colonization by bacteria. This clinical trial is performed to~     compare the safety and efficacy of the coated central venous catheter, Certofix® protect,~     with that of the non-coated standard catheter Certofix®.~   "
229313|NCT00555269|"~     To compare possible toxicities of membrane blue and infracyanine green in vivo by macular~     function and peripheral visual field.~   "
229289|NCT00555581|"~     The purpose of this study is to assess the safety and tolerability of imatinib mesylate~     (Gleevec) in patients with systemic sclerosis (scleroderma). Gleevec is a medication already~     FDA approved for the treatment of chronic myelogenous leukemia (CML), gastrointestinal~     stromal tumors (GIST), dermatofibrosarcoma protuberans tumors, Philadelphia~     chromosome-positive acute lymphoblastic leukemia, hypereosinophilic syndrome, and aggressive~     systemic mastocytosis. In-vitro studies have suggested that imatinib may inhibit collagen~     production by scleroderma fibroblasts, and in mouse models of fibrosis imatinib has been~     shown to decrease skin thickness.~      This is a Phase IIa, single center, prospective open label clinical trial of Gleevec in~     patients with systemic sclerosis. All patients will be treated with active drug for 12~     months. The primary objective of this study will be to determine the safety and tolerability~     of Gleevec in patients with systemic sclerosis, but important secondary outcomes of relevance~     will be improvement in disease status as defined by skin scores and indices of pulmonary~     function.~      Patients who complete the initial phase (described above) of the study will be eligible to~     participate in an extension phase. The purpose of the extension phase of the study is to give~     patients who participated in the phase IIa clinical trial of Gleevec at the Hospital for~     Special Surgery the opportunity to continue Gleevec treatment if both the treating physicians~     and the patient are in agreement that Gleevec had acceptable safety and tolerability, as well~     as possible efficacy during the initial year of therapy.~   "
229290|NCT00555568|"~     The objective of this study is to examine the mechanisms of action and outcome in mental~     health peer support groups. The study design is a randomized trial in which participants are~     assigned to one of three study arms: a recovery oriented mental health group led by peer~     facilitators (Vet-to-Vet), a recovery oriented group led by a clinician, or treatment as~     usual. Qualitative and quantitative methods will be used to assess substantive content and~     process of the recovery groups, as well as mental health and recovery outcomes.~   "
229291|NCT00555555|"~     To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in~     preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD)~     who undergo surgical procedures.~   "
229292|NCT00555542|"~     To study the effects of T cell in peripheral blood of patients with RA undergoing selective B~     cell depletion have not been studied. We analyze the B and T cell subsets in patients with~     active RA treated undergoing this form of treatment with rituximab.~   "
229293|NCT00555529|"~     -  The purpose of this project is to validate the peripheral arterial pressure waveform~          measurements technique of RAAP (radial artery applanation tonometry), in patients with~          moderate and severe COPD (Chronic Obstructive Pulmonary Disease), and to assess the~          degree of systemic endothelial dysfunction in these patients compared to cigarette~          smokers with normal lung function and non-smokers with normal lung function.~        -  Patients with moderate and severe COPD (GOLD stage II and III) will be studied and their~          results will be compared with age-matched healthy non- smokers and smokers.~        -  RAAP will be taken every 5 minutes for 15 minutes before salbutamol and every 5 minutes~          for another 15 minutes after salbutamol.~        -  Several parameters of lipoprotein profiles, anti-oxidant plasma capacity, inflammatory~          cytokines, hormones, growth factors and vascular cell adhesion molecules will be studied~          in blood. In addition, several inflammatory and oxidative markers will be studied in~          exhaled breath condensate. Lung function and impulse oscillometry will be made to~          investigate airway resistance, and exhaled NO (nitric oxide) at different expiratory~          flows will be measured to assess alveolar and bronchial NO. Clinical assessment~          including dyspnoea and depression scores will also be made.~   "
229294|NCT00555516|"~     Study Hypothesis:~      EW02 is a polysaccharide-enriched crude extract from black soybean (BS). BS has been used~     extensively by the Chinese as food or traditional Chinese medicine for hundreds of years. It~     has been used as monotherapy to treat Diabetes, menorrhagia and leukorrhea. In combination~     with others, BS has been used to treat chemotherapy-induced leukopenia on more than 300 pts.~     The daily doses were 15g bid to 50g tid for 21 days. Side effects were generally mild,~     including epigastric discomfort, numbness, insomnia, and dry mouth. Recently BS was found to~     promote myelopoiesis and inhibit tumor growth through immunomodulation. In vitro assays~     showed BS-PS can stimulate production of cytokines and increase blood progenitors. In vivo~     studies also demonstrated that BS-PS can reduce neutropenia in mice received 5-FU by~     stimulating myeloid colony formation. We hypothesize that EW02 can reduce neutropenia in~     cancer patients who receive chemotherapy without side effects.~   "
229295|NCT00555503|"~     This is a registry for patients who have a risk-reduction mastectomy (prophylactic~     mastectomy) due to being at high risk for developing breast cancer, followed by breast~     reconstruction. Eligible patients include those who have a breast cancer-related gene, a~     strong family history of breast cancer, or a personal history of high-risk conditions such as~     cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the~     registry before surgery, and are followed for up to ten years afterwards. In addition to~     studying medical outcomes, we will periodically survey patients for quality-of-life issues~     and psychological well-being. There is no compensation for being enrolled in this registry.~     This registry is conducted through the Department of Plastic Surgery at Georgetown University~     Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi~     Comprehensive Cancer Center at Georgetown University.~   "
229296|NCT00555490|"~     we conducted a longitudinal 4-year clinical trial to determine the long-term effects of soy~     consumption on lipid profiles, renal-function indices and CRP level among type 2 diabetic~     patients with nephropathy.~   "
229314|NCT00555256|"~     To define the optimal dose of sunitinib when given in combination with rapamycin 2mg.~      To determine the maximum tolerated dosage of sunitinib and rapamycin given in this fashion.~      To determine the how many times and how severe other toxicities of this combination therapy.~      To determine how quickly the patient(s) will respond the the drug, overall survival and time~     to progression for this combination therapy.~   "
229315|NCT00555243|"~     The primary goal of this study is to answer whether validated laparoscopic simulators truly~     affect real time performance in the operating room among Gynecology residents.~   "
229805|NCT00548717|"~     This trial will test the hypothesis that the combination of sirolimus, mycophenolate mofetil,~     and bortezomib will be effective in preventing both acute and chronic GVHD after reduced~     intensity allogeneic stem cell transplantation.~   "
229297|NCT00555477|"~     Women with hormone-receptor positive breast cancer are typically treated with hormone therapy~     as part of their treatment after surgery. In the past few years it has been found that~     treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women.~     Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are~     not effective in women who have functioning ovaries. Some women are premenopausal at the time~     they are diagnosed with breast cancer, but then stop having menstrual periods when they are~     treated with chemotherapy. It is unclear if these women can also be treated safely with~     aromatase inhibitors.~      In this clinical trial the researchers will try to answer this question. Women with hormone~     receptor positive breast cancer who become postmenopausal with chemotherapy will be invited~     to participate in this study. Each woman will be treated with one of the aromatase~     inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries~     do not start making estrogen. If her estrogen level remains low, then she will continued to~     be followed for 18 months. If the level increases to the level typically seen in~     premenopausal women, however, then she will stop taking part in this study.~      The study will also evaluate multiple factors that may help doctors predict who will tolerate~     the therapy without having their ovaries start making estrogen again. Some of the factors to~     be evaluated include other hormone levels (blood tests) as well as family history of early~     menopause (mother, sisters). In addition, changes in certain genes that affect how patients'~     bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients~     recover ovarian function. Overall, the purpose of the study is to determine which patients~     who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor~     treatment safely, and how often the patients' ovarian function needs to be tested during~     treatment.~   "
229298|NCT00555464|"~     The goal of this study is to determine the safety and efficacy of Prednisolone and~     Vincristine for treatment of large, complicated infantile hemangiomas. The diagnostic,~     therapeutic and response criteria experimentally determined in this study will be used as a~     framework for future infantile hemangioma studies.~   "
229299|NCT00555451|"~     The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of~     HE3286 when administered daily for 28 days to obese adult subjects and to assess potential~     activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with~     type II diabetes mellitus will be treated at 10 mg (5 mg BID).~   "
229300|NCT00555438|"~     Fondaparinux is an antithrombotic agent having already received a regulatory approval by the~     European Authorities in venous thromboembolic event prevention after major orthopaedic~     surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The~     bleeding risk associated with this prescription is highly related to renal function evaluated~     by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to~     prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of~     2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated~     pharmakinetic data without any support of clinical data.~      prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5~     mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl~     between 20 and 30 ml/min and undergoing a major orthopaedic surgery.~   "
229301|NCT00555425|"~     The aim of the study is to determine whether buprenorphine/naloxone maintenance versus~     detoxification using buprenorphine/naloxone, in prescription opioid dependent patients~     receiving primary care management and drug counseling in an office-based setting, leads to~     decreased illicit opioid use.~   "
229302|NCT00555412|"~     The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of~     multiple inhaled doses of Staccato Loxapine.~   "
229303|NCT00555399|"~     The goal of this clinical research study is to learn if vorinostat when given with~     isotretinoin and temozolomide can help to control glioblastoma or gliosarcoma. The safety of~     these drug combinations will also be studied.~   "
229304|NCT00555386|"~     There is evidence to suggest that some dietary components can reduce the risk of breast~     cancer. In this pilot study two such components, isoflavones (compounds found in soy~     products) and selenium, will be given to women classed as at moderate to high risk of the~     disease. The aim is to determine some novel biomarkers of risk and to see the effect of~     supplementation on them.~   "
229305|NCT00555373|"~     Damage and scarring of a transplanted kidney has become the most common cause of loss of the~     transplanted kidney. This kidney damage is a complex process caused by many factors including~     injury during obtaining and transplanting the kidney, injury from the immune system, injury~     from infections, and injury from drugs used to stop rejection. This injury leads to scars~     that decrease the kidney's ability to function properly, and over time the kidney is lost.~     Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when~     used over time it has been shown to cause chronic damage and scarring in the transplanted~     kidney.~      The purpose of this experimental study is to determine whether children can safely be~     withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent~     research studies in adult transplantation have demonstrated that with the use of Rapamycin®~     (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase~     in rejection, with decreased scarring in the kidney, and with improvements in kidney function~     and survival of the kidney. A total of 50 children will enroll in this study at university~     centers around the country. This study will last about 3 years.~   "
229306|NCT00555360|"~     Informal caregivers, assisted by health information technology may help to fill the gaps in~     VA care management of heart failure patients by enhancing support for patients' treatment~     adherence, behavior changes, and symptom monitoring.~   "
229307|NCT00555347|"~     To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.~   "
229308|NCT00555334|"~     The purpose of the investigators' study is to prospectively evaluate whether nucleoid~     antiviral therapy will improve the outcome of radiofrequency ablation for hepatocellular~     carcinoma (HCC).~   "
229309|NCT00555321|"~     The purpose of this clinical research study is to evaluate the effects of belatacept,~     relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects~     receiving a liver transplant~   "
229310|NCT00555308|"~     An Emergency Department Targeted Ultrasound (EDTU) is an ultrasound examination performed by~     an emergency department physician, instead of a radiologist or ultrasound technician. EDTU is~     intended to be a readily assessable test performed at the bedside, to quickly and safely~     determine the presence of a disease state; it answers a binary question, as compared to~     formal ultrasound imaging which seeks to determine the cause of a patient's symptoms.~      The objective of this study is to determine the accuracy of EDTU in patients suspected of~     renal colic. By demonstrating excellent test characteristics, these investigators hope that~     this research will be used to incorporate EDTU for hydronephrosis into standard emergency~     care in Canada.~   "
229311|NCT00555295|"~     The purpose of this study is to determine the survival after laparoscopic colectomies due to~     carcinoma.~   "
229316|NCT00555230|"~     The purpose of this study is:~        1. To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA~          compared to healthy controls.~        2. To determine those clinical and biological measures that best predict the presence of~          plaque and increased arterial stiffness.~        3. To ascertain the efficacy and safety of rosuvastatin in the prevention of~          atherosclerosis in patients with RA measured by carotid intima-media thickness (IMT) and~          pulse wave velocity (PWV).~   "
229317|NCT00555217|"~     Diabetes is the leading cause of end-stage renal disease (ESRD) in the United States. The~     overall rate of ESRD secondary to diabetes has risen 68% since 1992. Medications that block~     the renin angiotensin system have been shown to decrease the progression of diabetic~     nephropathy. The use of an angiotensin receptor blocker (ARB) has been shown to decrease the~     risk of progression of kidney disease in two studies of individuals with Type 2 diabetes and~     proteinuria. Despite the use of an ARB, the incidence of renal failure remained high in the~     treated group in both studies. The combination of an angiotensin converting enzyme inhibitor~     (ACEI) and ARB can lead to more complete blockade of the renin angiotensin system. In~     diabetic kidney disease, combination therapy has been shown to decrease proteinuria in~     short-term studies. Although there are encouraging results for improvement in proteinuria~     there are no data on progression of kidney disease for the use of combination of ACEI and ARB~     therapy in patients with diabetes. In addition, there could be an increased risk of serious~     hyperkalemia in individuals with diabetes who receive combination ACEI and ARB. The~     investigators therefore propose a randomized double blind multi-center clinical trial to~     assess the effect of combination of ACEI and ARB in patients with diabetes and proteinuria on~     progression of kidney disease.~   "
229318|NCT00555204|"~     The purpose of this study is to test if the investigational medication ABT-089 is a safe and~     effective treatment for Alzheimer's disease.~   "
229319|NCT00555191|"~     Different published studies has shown a possible co-variation between leakage of fructose to~     the great bowel and exacerbation of irritable bowel syndrome (IBS) symptoms.~      The aim of the FINN trial is to study the role of fructose malabsorption in patients with IBS~     in order to evaluate different diagnostic criteria for fructose malabsorption and at the same~     time study the effect of diet treatment in this cohort of patients and estimate the~     prevalence of fructose malabsorption.~   "
229320|NCT00555178|"~     Polymorphic light eruption (PLE) is a photodermatosis with an extremely high prevalence,~     particularly among young women (up to 20%). The disease is characterized through itchy skin~     lesions on sun-exposed body sites occurring after sun exposure mostly in spring and early~     summer. Its etiopathogenesis is unknown but resistance to UV-induced immunosuppression with~     subsequent immune reactions against skin photoneoantigens has been suggested. Regulatory T~     cells (CD4+CD25+FoxP3+) (Tregs), a subset of T helper cells, are crucial for the induction of~     immunosuppression. We will test the hypothesis that PLE patients show pathogenic fluctuating~     Treg levels and function and related parameters over the seasons of the year, possibly being~     responsible for lack of immune modulation and autoimmunity in PLE. Natural or medical~     photohardening may normalize Treg deficiency in PLE and lead to clinical adaption in summer.~     Better insight into the pathogenesis of PLE may give clues to develop new therapeutic~     strategies.~   "
229321|NCT00555165|"~     Evaluation of pre and post−implantation management of patients with end−stage age−related~     macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under~     CE Mark indicated use. This study is designed to evaluate in particular the optimal~     parameters for patient selection for use of this device in routine clinical practice.~   "
229322|NCT00555152|"~     This randomized phase I/II trial studies the side effects and best dose of lapatinib~     ditosylate and to see how well it works in treating patients with ductal breast carcinoma in~     situ. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
229323|NCT00555139|"~     To compare by neuroimaging techniques and public speaking, the way social anxiety patients~     respond after the administration of GW876008, GSK561679, alprazolam and placebo~   "
229324|NCT00555126|"~     Trauma is the leading cause of death in young adults, bleeding and infection are major~     concomitant problems. We test the hypothesis that fast, perioperative warming with an~     endovascular catheter versus forced air warming may improve patient outcome (primary outcome:~     combined perioperative morbidity, secondary outcome: bleeding, infection).~   "
229325|NCT00555113|"~     Pseudoxanthoma elasticum is a disease whom frequency is estimated about 1/50000 to 1/100 000.~     There is a female preponderance with a sex-ratio of 2:1. PXE is transmitted according either~     to an autosomal dominant mode or to an autosomal recessive one. Mutations in the ABCC6 gene~     on chromosome 16p13.1 have recently been identified causing PXE. The elastic fibers slowly~     become mineralized mainly in the skin, the eyes, and the cardiovascular system. PXE is a~     multisystem disease that includes a spectrum of clinical manifestations affecting the skin,~     the eye or the cardiovascular system as well as other tissues. It can be responsible for~     severe and life threatening complications. Skin changes are usually the first manifestations~     and begin in early childhood. The vital prognosis of PXE depends on the severity of the~     cardiovascular lesions that could be responsible for sudden death in children and young~     adults.~      Ocular manifestations are quite constant and include chorioretinal scarring, pigmentary~     changes or angioid streaks. The natural evolution of the angioid streaks leads to their~     enlargement or to the occurrence of subfoveal choroidal neovascularizations and hemorrhages~     leaving macular scares. A self-monitoring is recommended since early treatment of subfoveal~     CNV is the only way to minimize their pejorative consequences. The gold standard treatment of~     the CNV consists in the photocoagulation. New therapeutics has been developed including~     photodynamic therapy or intravitreal injection of anti-angiogenic agents and they seems to be~     effective to reduce the immediate complications of a limited CNV. This evolution explains~     that 50 to 70 % of the patients have a poor vision or legal blindness of one or both eyes.~     However, little is known about the age of occurrence of visual impairment in PXE patients.~     That is the reason why we decided to review the ophthalmologic status and visual history of~     our population of PXE patients according to their age.~   "
229326|NCT00555100|"~     CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD),~     safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without~     dexamethasone in Japanese subjects with previously treated MM. The study will consist of two~     cohorts: 1) Monotherapy Maximum Tolerated Dose (MTD) Determination Cohort; and 2)~     Combination Treatment Cohort.~   "
229358|NCT00554671|"~     This is a multi-site open label randomized controlled study of patients with type 2 diabetes~     undergoing pharmacist-led group medical visits that include education by a multi-disciplinary~     personnel, behavioral modification and pharmacotherapy case management vs. usual care~   "
229327|NCT00555087|"~     The main objective of this study is to evaluate the response of erectile dysfunction in~     hypogonadotrophic males with Testosterone undecanoate i.m. as per IIEF and the question of~     the GAQ (Global Evaluation Questionnaire) after 42 weeks of treatment.~      Secondary Study Objectives~        -  To monitor adverse events and changes in hemoglobin and serum chemistry with: PSA, lipid~          profile, renal-hepatic profile and glycemia, and control by means of a rectal digital~          examination.~        -  To Determinate physiologic reconstitution in patients under treatment by means of total~          and free testosterone dosage.~   "
229328|NCT00555074|"~     The purpose of this study is to compare the efficacy and safety of sodium tungstate versus~     placebo in patients with obesity (grade I and II).~   "
229329|NCT00555061|"~     A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects~     (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses,~     or impetigo (bullous and non-bullous).~   "
229330|NCT00555048|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Giving~     chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell~     transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor~     can make an immune response against the body's normal cells. Giving tacrolimus and~     methotrexate after the transplant may stop this from happening.~      PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together~     with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how~     well it works in treating patients with hematologic cancer.~   "
229331|NCT00555035|"~     To determine safety, tolerability and pharmacokinetics of GSK1349572~   "
229332|NCT00555022|"~     GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic~     obstructive pulmonary disease (COPD)~   "
229333|NCT00555009|"~     To establish the effects of genotropin replacement on cognitive function in patients with~     severe growth hormone deficiency after traumatic brain injury.~   "
229334|NCT00554996|"~     This study is a prospective pilot clinical trial investigating the use of urinary catheters~     coated with benign E. coli in geriatric subjects.~   "
229335|NCT00554983|"~     Efficacy and Safety from a recombinant folding variant of Bet v 1~   "
229336|NCT00554970|"~     The purpose of this study is to examine the blood levels of two doses of MAP0010 (a~     corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with~     twice daily dosing over 7 days.~   "
229337|NCT00554957|"~     The annual frequency of injury among dancers has been reported to range between 23-84% while~     as many as 95% of professional dancers have ongoing pain. The discrepancy between the number~     of reported injuries and the amount of pain reported at any given time could be related to~     the definition of injury, or how dancers' themselves perceive injury with respect to pain and~     activity limitation thresholds. For many reasons, dancers may be dancing through or past what~     health care providers may conceive as injury. This can put them at risk of further or chronic~     injury. The purpose of this study is to understand at which point pain limits a dancer's~     ability to continue to perform and whether this is influenced by available medical services,~     a supportive dance environment, or other factors. In addition, the issue of non-reporting of~     injuries will be studied. This is very important as this will affect all measures of injury~     frequency and risk for dancers.~   "
229338|NCT00554944|"~     The investigators propose to determine esophageal Doppler goal-directed fluid requirements in~     lean, overweight, obese, and morbidly obese patients with the goal of developing a body mass~     index (BMI)-specific fluid replacement strategy. Specifically, th investigators will test the~     hypothesis that perioperative fluid requirements on a per-kg basis varies as a function of~     BMI. Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or~     genital prolapse repair will be eligible to participate~   "
229339|NCT00554918|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Zoledronic acid may help relieve some of the symptoms caused by bone metastases.~     Radioactive substances, such as strontium chloride Sr 89, may help relieve bone pain caused~     by prostate cancer. Giving docetaxel together with prednisolone with or without zoledronic~     acid and/or strontium chloride Sr 89 may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying the side effects and how well giving~     docetaxel together with prednisolone works with or without zoledronic acid and/or strontium~     chloride Sr 89 in treating patients with prostate cancer metastatic to bone that has not~     responded to hormone therapy.~   "
229340|NCT00554905|"~     The purpose of this study is to prospectively evaluate whether combined RFA and TACE~     (RFA-TACE) result in better survival outcomes than RFA alone in patients with HCC.~   "
229341|NCT00554892|"~     The aim of this controlled multicentric study is to assess rectal cancer surgery with~     sphincter preservation without pre operative mechanical bowel preparation~   "
229342|NCT00554879|"~     The purpose of this study is to determine the safety and efficacy of acupuncture in the~     treatment of moderate to severe dry eye by replicating the study design of the previous~     protocol and to see the study through to its completion.~   "
229343|NCT00554866|"~     Plasma L-arginine concentrations are decreased in premature infants with necrotizing~     enterocolitis (NEC). A carbamoyl-phosphate synthetase 1 (CPS1) polymorphism has been~     correlated with low plasma concentrations of L-arginine in neonates (> 35 weeks of~     gestation). Recently Moonen et al (Pediatr Res 2007; 62(2):188-90) described a correlation~     between this CPS1 T1405N single nucleotide polymorphism (SNP) and the presence of NEC in VLBW~     infants. However there is no data about the correlation between the plasma arginine~     concentrations and the T1405N SNP in the CPS-1 gene in VLBW infants. In the present project~     we postulate that T1405N SNP in the CPS-1 gene is associated with lower plasma arginine~     concentrations and is also a risk factor for the development of NEC.~   "
229822|NCT00548496|"~     This is a study designed to test the safety and effectiveness of SB-751689 in the treatment~     of a distal radius fracture in post-menopausal women and men in comparison to placebo to~     determine if healing time of the fracture can be decreased.~   "
229344|NCT00554853|"~     Patients with rheumatoid arthritis have a significantly higher risk to develop heart attacks~     and other complications of their blood vessels. New therapies are needed to prevent this~     complication. The purpose of this study is to establish the role of the medication~     pioglitazone in improving the function of the blood vessels and heart and decreasing the risk~     of future atherosclerosis development in individuals with rheumatoid arthritis. As a~     secondary aim-point, we will evaluate the efficacy of pioglitazone in improving rheumatoid~     arthritis disease activity and markers of inflammation.~   "
229345|NCT00554840|"~     The purpose of this proposed pilot study is to examine the use of varenicline in people with~     schizophrenia to specifically assess tolerability and efficacy for smoking cessation.~     Specifically, The primary objective of this pilot study is to determine if taking of~     varenicline along with an individual smoking cessation supportive program is a safe and~     effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the~     varenicline treated patients will achieve higher rates of smoking cessation than those who~     receive placebo and individual support.~   "
229346|NCT00554827|"~     This study is being conducted to identify how much and how often pralatrexate, given with~     vitamin B12 and folic acid, can be given safely to patients with cutaneous T-cell lymphoma~     (CTCL) that has relapsed (returned after responding to previous treatment) or is refractory~     (has not responded to previous treatment). It is also being conducted to get information on~     whether or not pralatrexate is effective in treating relapsed or refractory CTCL.~   "
229347|NCT00554814|"~     The primary purpose of the study is to demonstrate the superiority of Bledilait milk (Biofer®~     2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants~     (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months~     of consumption of studied milks.~   "
229348|NCT00554801|"~     The incidence of central auditory dysfunction in war fighters who are exposed to~     high-explosive blasts while serving in combat have not been clearly determined. The~     objectives of this study are to determine whether central auditory processing (CAP) disorders~     are associated with exposure to high-explosive blasts. This study will also examine the~     incidence, magnitude and timing of spontaneous recovery of CAP function from blast exposure.~     The information provided by this study will help guide clinicians in both the military and VA~     health care systems regarding the likelihood of central auditory processing disorders in~     soldiers returning from deployment and suggest some clinical rehabilitative strategies for~     the treatment of these patients with CAP deficits.~   "
229349|NCT00554788|"~     This phase III trial is studying the side effects and how well giving combination~     chemotherapy together with autologous stem cell transplant and/or radiation therapy works in~     treating young patients with extraocular retinoblastoma. Giving chemotherapy before an~     autologous stem cell transplant stops the growth of tumor cells by stopping them from~     dividing or killing them. After treatment, stem cells are collected from the patient's blood~     and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the~     stem cell transplant. The stem cells are then returned to the patient to replace the~     blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high~     energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy~     and/or autologous stem cell transplant may kill any remaining tumor cells.~   "
229350|NCT00554775|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib~     may also make tumor cells more sensitive to radiation therapy. It is not yet known whether~     giving whole-brain radiation therapy together with erlotinib is more effective than~     whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and~     brain metastases.~      PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and~     erlotinib to see how well they work compared with whole-brain radiation therapy alone in~     treating patients with advanced non-small cell lung cancer and brain metastases.~   "
229351|NCT00554762|"~     The purpose of this study is to assess the dose response and efficacy of single and repeat~     doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.~   "
229352|NCT00554749|"~     The purpose of this pilot study is to explore the outcome of a manual based treatment for~     children with Selective Mutism~   "
229353|NCT00554736|"~     This is a placebo controlled double-blind single center study initiated and sponsored by~     CALPIS, Inc., Japan, and CALPIS U.S.A., Inc., Torrance, CA.~      The overall objective of this study is to establish the benefit of a bacterial product,~     Lactobacillus acidophilus strain L-92 (CALPIS U.S.A., Inc., Torrance, CA), in patients with~     allergic rhinitis.~   "
229354|NCT00554723|"~     CHIMES is a double blind, placebo controlled, randomized, multicenter study to test the~     hypothesis that NeuroAid is superior to placebo in reducing neurological deficit and~     improving functional outcome in patients with cerebral infarction of an intermediate range of~     severity.~   "
229355|NCT00554710|"~     The study prospectively compares two treatment algorithms for newly diagnosed Crohn's~     disease: one 'aggressive' treatment with early introduction of immunomodulators and~     biologicals and one 'standard treatment' with corticosteroids and only later introduction of~     immunosuppressives and biologicals if disease activity requires that.~   "
229356|NCT00554697|"~     The purpose of this study is to determine whether diabetics have decreased amounts of oxygen~     in the skin compared to non-diabetic individuals, and if the amount of oxygen in the skin~     changes when given more oxygen to breathe around the time of surgery. To do this, the~     investigators will be measuring the amount of oxygen in the skin of diabetic and non-diabetic~     individuals who will be undergoing abdominal surgery lasting 2-4 hours. These measurements~     will be taken at three different times.~   "
229357|NCT00554684|"~     1. Patients greater than 90 years of age will have poorer outcomes in terms of mortality~          than younger patients controlling for disease and acuity~        2. Patients greater than 90 years old will consume more resources than younger patients~          controlling for disease and acuity~        3. Patients greater than 90 years old will show lower levels of function than younger~          patients controlling for disease and acuity~        4. Patients greater than 90 years old will show lower levels of HRQOL at 90-120 days post~          ICU discharge than younger patients controlling for disease and acuity~   "
246435|NCT00327522|"~     The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK~     Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .~   "
229359|NCT00554658|"~     Aim of the study is to assess the effect of quetiapine treatment in neuroleptic naive,~     first-episode schizophrenic patients on aspects of functional and structural neuroplasticity~     assessed by means of transcranial magnetic stimulation and voxel-based morphometry. Main~     outcome measure is a change in gray matter density under quetiapine treatment from baseline~     to steady-state-treatment after 3 weeks.~   "
229360|NCT00554645|"~     The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as~     implied by the standard treatment but from difficulties in following the advice. The~     hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be~     more efficient in obtaining weight reduction. The effect of psychological group treatment of~     severely overweight children and their parents is compared with traditional nutritional~     information. In other words: Which is better: back-up or enlightenment?~   "
229361|NCT00554632|"~     This study was a randomized, investigator-blinded, cross-over, clinic trial using twenty-four~     healthy women aged 18-35. All women received two months of the birth control patch or birth~     control pill, two months without any drug, then two months of the alternative drug. The birth~     control patch contained 0.75 milligrams ethinyl estradiol and 6 milligrams norelgestromin.~     The birth control pill contained 35 micrograms ethinyl estradiol and 250 micrograms~     norgestimate. Blood samples were taken before and after each treatment and were analyzed for~     the following lab values: D-dimer, von Willebrand factor, factor VIII, total and free protein~     S, antithrombin, fibrinogen, C-reactive protein and normalized activated protein C~     sensitivity ratio (nAPCsr). Two thrombin generation-based assays were used: the~     α2macroglobulin-thrombin endpoint method (α2M-IIa) and calibrated automated thrombinography~     (CAT).~   "
229362|NCT00554619|"~     The primary objective of this study is to evaluate the safety of long-term administration of~     GSK1325760A in patients with PAH.~      The secondary objectives of this study are to evaluate long-term administration of~     GSK1325760A on:~        -  Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO~          Functional Classification and time to clinical worsening of PAH~        -  Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk~          test [6MWT])~        -  Change in plasma brain natriuretic peptide (BNP) levels~        -  Cardiopulmonary hemodynamics parameters (as measured by echocardiography)~   "
229363|NCT00554606|"~     This study will assess the long-term safety and tolerability of ACZ885 in patients with~     rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or~     improvement of joint structure and bone mineral density, and long term maintenance of~     health-related quality of life.~   "
229364|NCT00554580|"~     The investigators hypothesise that CPAP + pharmaceutical treatment, compared to~     pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the~     patients before H2 after the inclusion time and decreases the rate of death and tracheal~     intubation during the first 48 hours.~   "
229365|NCT00554567|"~     This community-based clinical trial based in two districts of rural Maharashtra, India~     compares utilization of an intervention model of fully-decentralized, or rural primary~     clinic-based, HIV testing and care services, with a control model of the Indian government's~     partially-decentralized HIV services, offering rural referral clinic testing and urban-based~     HIV care.~   "
229366|NCT00554541|"~     This research project is investigating the relationship between body weight and function of~     the leg veins using a special non-invasive technique known as venous plethysmography.~   "
229367|NCT00554528|"~     The aim of the study is to evaluate the impact of the cervical disk surgery on the~     deterioration of the adjacent levels. The investigators compare the radiological~     deterioration of adjacent levels, at 3 years, in both situation of fusion and arthroplasty.~     220 patients are enrolled and randomized to receive fusion or prosthesis. Radiological and~     clinical follow-up is organized for a period of 3 years.~   "
229368|NCT00554515|"~     High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug~     Administration (FDA) for the treatment of metastatic kidney cancer and is a standard~     treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer~     that can produce a remission of disease that lasts after treatment is completed. However,~     most patients who receive IL-2 do not benefit and all patients experience potentially~     dangerous side effects.~      Recent research has suggested that certain patients may respond better to IL-2 than others.~     The Cytokine Working Group is currently conducting a clinical trial that aims to identify and~     confirm this research and narrow the application of IL-2 to those patients most likely to~     benefit.~   "
229369|NCT00554502|"~     -  Evaluation of the efficacy of an immunosuppressive therapy added to a comprehensive~          supportive therapy to induce a clinical remission in patients at risk for progressive~          IgAN~        -  Investigation of differences between the treatments regarding the number of patients~          loosing more than 15 ml/min of GFR.~   "
229370|NCT00554489|"~     RATIONALE: Physical activity sessions may help improve physical function, quality of life,~     and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia.~      PURPOSE: This clinical trial is studying how well physical activity works in improving~     quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.~   "
229371|NCT00554476|"~     To compare the effectiveness of two combined therapeutic methods including corticosteroid~     injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs~     (NSAIDs).~   "
229372|NCT00554463|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating~     factors, such as G-CSF or pegfilgrastim, may increase the number of immune cells found in~     bone marrow or peripheral blood and may help the immune system recover from the side effects~     of chemotherapy and radiation therapy.~      PURPOSE: This phase II trial is studying G-CSF and pegfilgrastim to see how well they work in~     treating neutropenia in patients undergoing combination chemotherapy and radiation therapy~     for limited stage small cell lung cancer.~   "
229373|NCT00554450|"~     The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance~     in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type~     2 diabetic and healthy subjects with normal renal function~   "
229374|NCT00554437|"~     Intensive falls prevention programs have been shown to be effective in reducing falls;~     however, a number of practical programs, based in community setting have not been successful~     at reducing rate of falls. The purpose of this study was to test, in a randomized, controlled~     trial, the efficacy of this intermediate-intensity, individual, multifactorial model to~     reduce falls. It was hypothesized that more contacts would lead to greater adherence and~     efficacy in reducing falls.~   "
229375|NCT00554424|"~     The purpose of this study is to see whether injecting local anaesthetic into the vaginal~     tissues,just prior to transvaginal egg collection,will decrease the amount of pain~     experienced by women having their eggs collected on an IVF cycle. All women will also receive~     intravenous sedation as required as well as a sleeping tablet thirty minutes prior to the~     procedure which is our routine procedure for egg collection.~   "
229376|NCT00554411|"~     Hypothesis: Changing to Travatan Z therapy increases the tear film break up time of subjects~     on Xalatan therapy presenting with ocular surface disease.~   "
229377|NCT00554398|"~     An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART~     regimen with persistent HIV-1 viral suppression could increase the slope of decay of the~     HIV-1 latent reservoir.~   "
229378|NCT00554385|"~     The objective of this study is to evaluate the long-term safety and tolerability of ABT-089~     in children with ADHD.~   "
229379|NCT00554372|"~     The purpose of this research study is to determine whether JX-594 (Pexa-Vec) has significant~     anti-tumoral activity and tolerability in primary hepatocellular carcinoma and to determine~     the dose to be used in further testing.~   "
229380|NCT00554359|"~     This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic~     study. The study will be conducted in approximately 8-10 centers in the United States and~     Switzerland. Up to 32 patients who have undergone major cardiovascular surgery will~     participate. Patients will receive a single IV injection of I5NP or placebo following~     cardiovascular surgery. I5NP will be administered 4 hours (+/- 30 minutes) following removal~     of the cardiopulmonary bypass machine (CBM).~      The duration of the study is approximately 44 days, inclusive of a 14 day screening period.~     Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient~     visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 and Day 7 or hospital~     discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls will be~     made at 6 and 12 months after date of surgery.~   "
229381|NCT00554346|"~     Post surgical pain associated with ligament reconstruction may persist for few days after the~     surgical procedure. Arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain~     through oral administration. This study will test the safety and efficacy of Arcoxia in the~     management of post-operational pain in patients receive the ligament reconstruction surgery.~   "
229382|NCT00554333|"~     Primary objective:~      * Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route~     at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular~     route at the same dosage in term of HA antibody titres~      Secondary objectives~        -  Immunogenicity~             -  To describe the immune response 21 days after vaccination with the influenza~               vaccine administered by ID route versus the adjuvanted influenza vaccine~               administered by IM route..~             -  To describe the compliance of both vaccines administered with the European Medicine~               Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly~               subjects~        -  Safety~           - To describe the safety profile after vaccination in each group~        -  Acceptability~             -  To describe the pain at the injection site~             -  To describe the comfort of the injection~   "
229383|NCT00554320|"~     We will rigorously test whether modulation of the motor cortex by transcranial direct current~     stimulation (tDCS) is an effective treatment for patients with chronic pelvic pain through~     the following specific aims:~      A) The primary aim of this study is to determine whether transcranial direct current~     stimulation applied to the motor cortex in patients with chronic pelvic pain induces a~     significant decrease in the pain or symptoms as compared with sham tDCS. We will also measure~     changes in the clinical symptom scores of multiple pelvic organs, drug intake (narcotic),~     anxiety, depression, traumatic stress, as well as overall improvement in the quality of life~     to assess the effects of this treatment.~      B) Determine the duration of the clinical effects of tDCS. We will therefore compare the~     amelioration of pain and related symptoms between active and sham tDCS for one year following~     treatment.~      C) Determine whether tDCS changes the threshold for pain detection as compared with sham~     tDCS. Patients with chronic pelvic pain have a lower threshold for pain as compared to~     healthy subjects and we hypothesized that this threshold will increase after stimulation with~     tDCS.~      D) Finally, we will examine whether 5 days of tDCS treatment is safe for use in chronic~     pelvic pain patients. Safety will be assessed through neuropsychological tests and adverse~     event reporting.~   "
229384|NCT00554307|"~     The purpose of this study is to determine how the medications which are used to close the~     patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow~     when compared to infants that are not treated with these medications. The medications being~     used for PDA closure are indomethacin and neoprofen.~   "
229385|NCT00554294|"~     A major goal in public health is to find effective, feasible and simple programs for~     overweight prevention among children. This controlled intervention study evaluates a simple~     environmental and behavioral modification for its efficacy in preventing overweight of~     children in the school setting. The intervention strategy focuses solely on the promotion of~     drinking tap water. The study was conducted in 32 elementary schools including about 3000~     children in two German cities over 1 school year.~   "
229436|NCT00553605|"~     This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled~     trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib~     40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in~     outpatients presenting at emergency room settings. This trial is designed to show~     non-inferiority of parecoxib related to ketoprofen.~   "
229482|NCT00553007|"~     Periodontal disease is associated with the components of Metabolic syndrome, such as obesity,~     diabetes, hypertension and hyperlipidemia. Therefore, strong relation with periodontal~     disease and metabolic syndrome is suggested. the overall goal of this study is to define the~     relation between periodontal disease and metabolic syndrome, including atherosclerosis.~   "
229386|NCT00554281|"~     Hypoglycemia is the most common complication of Type 1 diabetes particularly in those who~     strive for good glycemic control. In some patients there is a loss of awareness of~     hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. Such~     a situation may carry risks that the patient may harm him or her self. Medtronic has recently~     developed a continuous glucose sensor that determines the glucose level every 3 minutes using~     a subcutaneous sensor and transmits the information to a remote device (Paradigm RT) that may~     be worn or left close by eg on a bedside table. The device may be programmed to alarm for a~     rapidly falling glucose or for low glucose levels.~      We propose to use this in 16 patients with severe hypoglycemia as evidenced by a high HYPO~     score and see if we can decrease the number of hypoglycemic reactions and document this~     improvement with a better HYPO score.~   "
229387|NCT00554268|"~     The goal of this clinical research study is to find the highest safe dose of PBI-05204 that~     can be given to patients with advanced solid tumors. The study will also look at how~     PBI-05204 is processed by the body, how it leaves the body, how it affects the body, and if~     it is affecting certain proteins in the cancer cells.~   "
229388|NCT00554255|"~     To investigate the safety and tolerability, PK and PD of SB751689 following single and 5-day~     multiple oral doses of 100, 200, and 400 mg in Japanese postmenopausal subjects.~   "
229389|NCT00554242|"~     A pilot study of 15 subjects will be conducted to confirm an acute effect of grape seed~     extract on endothelial function. We then will perform a a randomized, double blind, placebo~     controlled crossover study designed to investigate the benefit of grape seed extract/vitamin~     C treatment on endothelial function. Participants (n=40) will take a food supplement~     containing 450 mg of grape seed extract and 1500 mg of vitamin C or matching placebo for four~     weeks and then cross over to the alternative treatment (active supplement or placebo) for~     four weeks. We will examine endothelial function before and after each of the two treatment~     periods. The study will provide information about the vascular effects of these compounds.~   "
229390|NCT00554229|"~     Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054~     (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.~        -  This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054~          (Zibotentan) can improve survival compared with placebo.~        -  ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and~          spread by blocking Endothelin A receptor activity. This trial will look at the effects~          of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone~          metastases.~        -  All patients participating in this clinical trial will receive existing standard~          prostate cancer treatments in addition to trial therapy.~        -  Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive~          placebo in addition to standard prostate cancer therapy. By participating in this trial~          there is a 50% chance that patients will receive an agent that may slow the progression~          of the tumour.~        -  No patients will be deprived of standard prostate cancer therapy.~   "
229391|NCT00554216|"~     The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521~     compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.~   "
229392|NCT00554203|"~     Experimental studies suggest that systemic inflammation leads to endothelial dysfunction and~     atherosclerosis. This study will examine the effects of the anti-inflammatory drug~     sulfasalazine on endothelial function in patients with coronary artery disease. Subjects will~     be treated with sulfasalazine or to placebo for six weeks. After a two-week rest period,~     subjects will cross over to the alternative treatment. Endothelium-dependent flow-mediated~     dilation of the brachial artery will be studied before and after each drug. We hypothesize~     that anti-inflammatory therapy will reverse endothelial dysfunction in patients with coronary~     artery disease.~   "
229393|NCT00554190|"~     The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel,~     a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery.~     Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus~     tissues and Merogel applied to the middle meatus tissues on the opposite side.~   "
229394|NCT00554177|"~     he purpose of this study is to test whether a medication, called mifepristone (commonly known~     as the ³Morning-After-Pill²), can help to prevent emotional problems after someone has~     survived a traumatic experience. We are studying this medication for the treatment of~     Post-traumatic Stress disorder (PTSD.~   "
229395|NCT00554164|"~     The main purpose of the PETAL trial is to determine whether patients with aggressive~     non-Hodgkin's lymphomas with a persistently positive PET scan after two cycles of~     chemotherapy benefit from a change of the treatment protocol.~   "
229396|NCT00554151|"~     Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty~     Ring.~   "
229397|NCT00554138|"~     The aim of this study is to show whether rosuvastatin influences adenosine metabolism.~     Therefore we will determine whether rosuvasatin increases dipyridamole-induced vasodilation~     by increased adenosine receptor stimulation.~   "
229398|NCT00554125|"~     The purpose of this study is to evaluate the influence of sirolimus on outcome after OLT for~     HCC exceeding Milan criteria.~   "
229399|NCT00554112|"~     This VA CDA-2 proposal will test in detail if lifestyle intervention with aerobic exercise~     training improves the body's production of insulin in older people at risk to develop~     diabetes.~   "
229400|NCT00554099|"~     The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is~     safe and effective in the treatment of diverticulitis.~   "
229401|NCT00554086|"~     Multi-centre one year trial for patients who have rising PSA while on Casodex 50mg daily~     dose. Casodex dosage escalated to 150 mg tablet daily. Treatment will be continued until~     patient demonstrates clinical benefit at one year, PSA progression, toxicity, or withdrawal.~     Treatment will be continued after one year if patient demonstrates continued clinical~     benefit.~   "
229402|NCT00554073|"~     To investigate the diagnostic performance of whole body magnetic resonance angiography~     (WB-MRA) using two different magnetic resonance scanners at a field strength of 1.5 and 3T.~     The hypothesis is that use of the 3T system gives superior signals from the investigated~     arteries, when compared with 1.5T.~   "
229483|NCT00552994|"~     In stent neointimal hyperplasia may be less in the Cypher select plus stent compared to the~     Xience V stent in diabetic patients.~   "
229403|NCT00554047|"~     In the Netherlands a rapidly increasing number of multidisciplinary memory clinics (MMC)~     currently diagnose 25% of the patients with dementia. Following the diagnostic work-up, MMCs~     are increasingly involved in post-diagnosis treatment and coordination of care, which~     probably is very important for patients and caregivers, but also very time consuming and~     expensive. This study will focus on the important question whether this complex~     post-diagnosis treatment and care coordination, evaluated both on effectiveness and costs,~     should be carried out by MMCs (intervention) or by General Practitioners (GPs) (control) as~     pivot of delivery of health care for these patients.~      Objectives: To determine MMCs' effectiveness and cost-effectiveness in post-diagnosis~     treatment and care-coordination for dementia-patients and their caregivers compared to the~     post-diagnosis treatment and care coordination by GPs.~      Time schedule: 12 months for including patients and their caregivers and 12 months of~     follow-up.~      Annex Study: Specifically for the Health Technology Assessment (HTA) methodology study the~     main study will be extended with some experimental proxy measurements and alternative~     measurement approaches.~      The objective of this Annex-study is to explore the feasibility and validity of Health~     Related Quality of Life (HRQL) value measurement in dementia patients. And to study the~     characteristics of proxy rating in HRQL research in dementia and the suitability and validity~     of yielding HRQL measurements by proxy assessment. Furthermore to explore the validity,~     reliability, and feasibility of the EQ5D and EQ6D in dementia research (in patients and in/by~     proxies); response shift, and alternative (more simple) methods of HRQL measurement and~     validate the Dutch versions of the QOL-AD and the use of the CarerQol-7D in dementia~     research.~   "
229404|NCT00554034|"~     The purpose of this study is to determine the minimal number of patches needed to get an~     effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a~     cycle by the order they enter the study. After the first 20 patients [5 cycles], the effect~     of the number of patches will be tested. If there is no distinct reduction of beta~     glucuronidase in the GCF or of gingival index at the tested sites, more patients will be~     enrolled. Patients will be added one cycle at a time with results being tested and analyzed.~     The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have~     been reached.~   "
229405|NCT00554021|"~     The purpose of this study is to clarify the relationship between SIRS (Systemic inflammatory~     response syndrome) and the infection associated with the use of central venous catheters at~     Critical Care center in National Defense Medical College, Japan.~   "
229406|NCT00554008|"~     The study intends to compare the results of two surgical methods to remove the appendix in~     children with appendicitis. Specifically, up to 500 children over 3 years will be placed in~     two groups where the only difference in treatment is open or laparoscopic (scope) operation.~     Each group will be tracked for their baseline characteristics, events during operation and~     recovery, pain medication requirements, duration of hospital stay, and patient/family~     satisfaction.~      The investigators hypothesize that their will be no difference in the parameters measured~     between the techniques of appendix removal.~   "
229407|NCT00553995|"~     Physical inactivity induces vascular dysfunction and glucose intolerance during five days of~     bed rest. This study will investigate the effects of salsalate on these responses. Subjects~     will be randomized to treatment with salsalate or placebo for four days prior to initiation~     of bed rest. Vascular function in the brachial artery will be determined by ultrasound prior~     to treatment and before and after the 5-day bed rest protocol. We hypothesize that treatment~     with salsalate will be associated with protection again the development of glucose~     intolerance and vascular dysfunction in this setting.~   "
229408|NCT00553982|"~     Background:~      The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The~     implantation of a patellar component adds to the operation time and the costs of the~     operation.There is a huge variation as to whether the patella is resurfaced or not during~     TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing~     reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not~     possible and additional, high quality randomised trials are required.~      Purpose:~      The aim of this study is to determine whether ther is a difference between the two groups in~     knee pain, functions, patient satisfaction and quality of life after TKA.~   "
229409|NCT00553969|"~     This study will examine the individual and combined effects of Coreg CR and lisinopril, on~     cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo~     controlled comparison over a 9-month study period. Patients to be randomized will have~     pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least~     one additional cardiovascular risk factor.~   "
229410|NCT00553956|"~     In the framework of the epidemiological study, local psychologists are trained in Butare in~     carrying out diagnostic interviews with orphans and widows who experienced the Rwandan~     genocide. With the aid of standardized questionnaires they will assess trauma related~     symptoms as well as Prolonged Grief Disorder. Under the supervision of clinical experts from~     the University of Konstanz the local psychologists will carry out a randomized house to house~     survey (Phase 1).~      As a second step, a controlled randomized clinical trial will be carried out. Local~     psychologists will be trained in applying Narrative Exposure Therapy and Interpersonal~     Psychotherapy. Genocide survivors that will be identified with a PTSD diagnosis will randomly~     be assigned to either the treatment condition or a waiting list. The treatment group will~     receive 5 individual sessions of NET in addition to 3 individual IPT sessions. Subsequent~     3-months and 6-months post-tests will serve to evaluate the efficacy of this treatment module~     in alleviating trauma related symptoms and symptoms of prolonged grief. We expect a~     significant symptom reduction in the experimental group and no significant symptom reduction~     in the waiting list. After the 6-months post-test, the trained psychologists will train other~     psychologists in applying this treatment module under the supervision of clinical experts~     from the University of Konstanz. Afterwards, they will apply therapy to the victims from the~     waiting list.~      A 12-months follow-up will serve to evaluate the long-term effect of the NET/IPT combination.~   "
229411|NCT00553943|"~     The purpose of this study is to measure the rate of complete response (CR and UCR) at the end~     of a course of immuno-chemotherapy:~        -  before cerebral radiotherapy for PCL~        -  after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal~          involvement Toxicity of the protocol Overall survival Survival without relapse Long-term~          incidence of neurocognitive toxicity~   "
229437|NCT00553592|"~     To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with~     placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of~     pain intensity) associated with diabetic periperal neuropathy in adult outpatients.~      To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens~     treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral~     neuropathy.~   "
229438|NCT00553579|"~     The benefits of artificial tears to relieve dry eye symptoms include, but are not limited to:~     stabilizing the tear film layer, fluid supplement action, improving visual acuity, and~     comfort. Studies have found a relationship between some of these benefits. For example,~     stabilization of the tear film is important not only to increase the tear break up time~     (TBUT), but is key in improving and maintaining visual acuity. These studies have alluded to~     the fact that there may or may not be a relationship between residence time and visual~     performance. Viscosity is one reason behind the uncertainty. Some solutions contain polymers~     which influence the ocular surface when contacted. This can impact residence time and~     ultimately visual performance. No prior research has explored the direct relationship between~     residence time and visual performance.~      Residence time refers to the duration at which the artificial tear resides on the eye.~     Methods have been developed to assess residence time by admixing fluorescent tracers to the~     solution and then measuring the amount of fluorescence over time. The caveat to methods using~     certain tracers has lead to uncertainty in elimination measurements due to corneal~     penetration or differing molecular weights (MW) from the active vehicle ingredient in the~     solution. For example, low-MW tracers can be eliminated at a different rate than higher-MW~     polymers. In addition, the low-MW tracers may be able to penetrate the corneal epithelium~     giving a false pre-corneal residence time. Meadows, Paugh, Joshi, and Mordaunt addressed this~     issue by developing a technique using a polymer which did not penetrate the cornea and had~     the same MW as the active ingredient in the solution FITC-dextran. Based on the assumption~     that similar weights are eliminated at the same rate, this technique has shown to be more~     economic, manageable, and amendable than previous procedures measuring residence time.~      Any ophthalmic drop has the potential to impact visual acuity upon instillation due to the~     effect it has on the tear layer components. Studies have observed that taking artificial~     tears continuously over time tends to stabilize the tear layer thus minimizing the immediate~     drop in contrast sensitivity upon instillation. Measuring the visual effect of artificial~     tears, using contrast sensitivity as a measure, provides valuable information about the~     therapeutic effect of artificial tears that are meant to stabilize the tear film, thus~     improving visual acuity in dry eye patients.~      But what about the patient? There is a difference between residence time and retention of~     effect- which is often what matters the most for patients. Retention of effect refers to the~     beneficial effect of the drop. Currently there is no real measure of retention of effect.~     Doctors can assess the tear film objectively, but there have been no strong correlations~     between subjective dry symptoms and tear film stability. A possible reason for the lack of~     correlation may be due to the fact that subjectivity is difficult to quantify. However,~     scales like the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) have been~     established in an attempt to quantify subjective experiences such as visual quality. We will~     be using the NRS to gauge the comfort of the drop upon the initial application to get a~     general idea of the comfort the drop provides to the user.~      Although there have been several studies done on residence time and visual effect of~     ophthalmic formulations separately, there is no current research correlating these two~     aspects of therapeutic efficacy. This study will be the first to concurrently investigate~     residence time (using FITC-dextran) and visual effect of an ophthalmic formulation.~   "
229544|NCT00552188|"~     The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on~     vascular inflammation following 24 weeks of dosing.~   "
229412|NCT00553930|"~     Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective~     as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients.~      Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg~     weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an~     undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic~     hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected~     patients in real use conditions.~      Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration~     of 118 weeks in which 71 patients from several hospitals of the Servicio Andaluz de Salud~     will be enrolled. The usual clinical and analytical follow up will be performed but~     additional blood samples will be obtained for determination of interferon and ribavirin~     plasma levels. The primary end point wall be a sustained virologic response (defined as an~     undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid~     virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and~     end of treatment response rates will be evaluated as well as their relationships with the~     plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The~     safety and tolerability of the studied medications will be evaluated by means of clinical~     adverse events, physical examination and laboratory results.~   "
229413|NCT00553917|"~     The purpose of this study is to evaluate if during pregnancy, a common group of~     antidepressant medications (SSRI's) adequately treats the symptoms of depression and to~     evaluate if there are any effects of these medications on the newborn infant.~   "
229414|NCT00553904|"~     A pilot study of 15 subjects will be completed to determine whether acute consumption of~     cranberry juice has an effect on endothelial function. We will then complete a randomized,~     double blind, placebo controlled crossover study designed to investigate the effects of~     cranberry juice consumption on endothelial function. Participants (n=40) will drink 480 ml of~     double strength cranberry juice or a similar appearing and tasting placebo per day for four~     weeks. After a two week rest period, they will cross over to the other beverage. We will~     examine endothelial function before and after each of the two treatment periods. The study~     will provide information about the chronic vascular effects of cranberry juice.~   "
229415|NCT00553891|"~     This is a randomized, double-blind, placebo-controlled study to document the long-term effect~     of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy~     as reflected by the need for removal of the adenoids within one year of the treatment~     regimen. Subjects will be assigned treated with either mometasone furoate nasal spray or~     placebo for 3 months. Subjects will be followed for an addition 12 months. Serious AEs will~     be followed starting first dose-till 30 days after study treatment period completion.~      This study was terminated - Please see P04367 - Lebanon~   "
229416|NCT00553878|"~     Patient on an intermittent androgen deprivation protocol for biochemical recurrence after~     radical local therapy for prostate cancer,the addition of continuous dutasteride treatment,~     significantly prolongs the duration of the off treatment interval and time to androgen~     independence.~   "
229417|NCT00553865|"~     The purpose of this study is to determine the optimal dosage of the clinical trial which is~     evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with~     the uncomplicated essential hypertension.~   "
229418|NCT00553852|"~     Obesity and obesity-related diseases have reached epidemic proportions in Western countries~     (1-3). Laparoscopic-adjustable silicone gastric banding (LASGB) is a purely restrictive~     operation that determine effective weight loss without inducing malabsorption (4-6). However,~     also after LASGB body weight loss is almost invariably associated with Free Fat Mass (FFM)~     loss, and the relevance of the FFM contribution to total energy expenditure is well-known~     (7-8). Different endocrine axes are reported to affect FFM. We previously reported that low~     levels of DHEA-S, an adrenal steroid with controversial anti-adipogenic and anti-atherogenic~     effects, are increased after the massive and sustainable weight loss induced by LASGB in~     severely obese premenopausal women and correlated with the higher post-operative FFM (9-10).~     It is also well known that GH/IGF-I axis exerts relevant effects on FFM and that reduced GH~     levels might increase Fat Mass (FM) and reduce FFM (11,12). Morbidly obese patients have a~     reduced GH secretion, generally reversible after weight loss (13-14). In a recent study~     currently in press, we reported that a persistent deficiency in the GH/IGF-I axis in very~     obese females is associated to lower decrease in FM after LASGB. Low IGF-I plasma levels have~     also been reported to be independent prognostic factors of liver steatosis and non-alcoholic~     steatohepatitis in morbidly obese patients (15) and ultrasound- measured hepatic left lobe~     volume might represent a reliable tool for the evaluation of liver involvement in obesity~     (16). GH deficiency (GHD) in adult patients is associated with an increase in FM and a~     parallel decrease in FFM (17). The severity of GDH is correlated to cardiovascular risk, body~     composition abnormalities and bone loss, and decreased left ventricular ejection fraction~     (18-20). GH therapy has been demonstrated to be effective in normalizing body composition,~     with beneficial effects up to a 2-years follow-up period (21-24). GH therapy has also been~     reported to be effective in sparing FFM during weight loss in obese patients and metabolic~     syndrome (25,26). However, these studies have some limitations due to the duration of the~     treatment and the lack of a preliminary evaluation of the GH/IGF-I axis secretory status in~     obese patients before the GH therapy. At present there are no data on the evaluation of the~     GH/IGF-I status before and after bariatric surgery and the effectiveness of recombinant GH~     treatment in very severe obese patients.~   "
229419|NCT00553839|"~     Dosing of medications is based on the plasma level achieved with a given dose and how long~     the medicine remains in the body. This study is called pharmacokinetics-that is, what the~     body does to the medication. Ketamine is an intravenous medication used for anesthesia and~     sedation in children. However the pharmacokinetics of Ketamine has not been systematically~     studied. We propose to study the pharmacokinetics of ketamine in different age groups of~     children ranging from infants to teenagers.~   "
229420|NCT00553813|"~     The primary objective of the study is to assess the activity of TPI 287 as single agent~     therapy for patients with advanced, unresectable pancreatic cancer after failure of~     gemcitabine-containing therapy. Activity of TPI 287 will be determined by the 6-month~     survival rate.~   "
229421|NCT00553800|"~     This study will evaluate the combination of bevacizumab and erlotinib in elderly patients~     with advanced non-small cell lung cancer.~   "
229422|NCT00553787|"~     The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to~     placebo in treatment of obesity in an adult population with obesity related co-morbid~     conditions.~   "
229439|NCT00553566|"~     RATIONALE: Learning about the long-term effects of dietary, lifestyle, and environmental~     factors on the risk of cancer progression and recurrence may help the study of bladder cancer~     in the future.~      PURPOSE: This clinical trial is studying how dietary, lifestyle, and environmental factors~     affect patients with early-stage bladder cancer.~   "
229545|NCT00552175|"~     The purpose of the study is to determine if duloxetine can help patients with painful~     diabetic neuropathy.~   "
229423|NCT00553774|"~     Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular~     events in patients with coronary artery disease (CAD). CAD patients also show impaired~     function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate~     in adult blood and contribute to endothelial repair. Clinical studies suggest that~     endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa.~     Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an~     additive, positive effect in patients who are already receiving the maximal recommended~     therapies for risk factor modification. Therefore, the researchers propose to perform an~     investigator-initiated, randomized controlled cross-over study administering flavanol-rich~     cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement~     of endothelial function as measured by flow-mediated dilation (FMD) will be the primary~     endpoint of this study. The researchers propose to also measure determinants of FMD such as~     microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the~     number and function of EPCs in the blood. Importantly, detailed food questionnaires and~     plasma flavanols/metabolites will help to further support a causal link between~     flavanol-intake and improved vascular function.~   "
229424|NCT00553761|"~     The study is designed to evaluate the ability of pattern electroretinogram (PERG) and~     multifocal pattern electroretinogram (mfPERG) to measure and identify the pattern of band~     atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is~     that these electrophysiological tests were able to identify this such pattern. The idea is to~     investigate the ability of the these electrophysiological technics in detecting the neural~     loss from chiasmal compression and to evaluate the ability of PERG and mfPERG parameters to~     differentiate between eyes with band atrophy of the optic nerve and healthy eyes.~   "
229425|NCT00553748|"~     This is a ten subject, phase 1 study. The purpose of the Phase 1 study is to demonstrate drug~     safety in a target group of subjects with high grade brain cancer. This population represents~     a potential clinical population that may benefit from this PET imaging tracer. The study will~     also begin collection of baseline imaging data and allow us to gain information to improve~     design and conduct of future trials.~   "
229426|NCT00553735|"~     The purpose of this study is to determine whether Restasis is an effective treatment for~     preventing the occurrence and progression of dry eye syndrome in patients who have recently~     received a bone marrow transplant and are at risk to graft-versus-host disease.~   "
229427|NCT00553722|"~     It is well known that Aldosterone (aldo) can cause hypertension (HBP). Since aldo is known to~     cause the kidney to retain sodium (Na) and Na retention is known to cause HBP, it has been~     thought that the mechanism by which aldo causes HBP is by Na retention. Recent studies have~     suggested that aldo has many effects in addition to its ability to cause the kidney to retain~     Na. To test the hypothesis that aldo can cause HBP in a manner which does not involve Na~     retention, we plan, in this protocol, to give Eplerenone, a specific aldo antagonist, to~     patients on dialysis who have HBP. A positive effect of Eplerenone to lower HBP in these~     patients would support this hypothesis.~   "
229428|NCT00553709|"~     The purpose of this study is to determine whether nicotine is effective in the prevention of~     nausea and vomiting in non-smokers undergoing surgery~   "
229429|NCT00553696|"~     To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered~     in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.~   "
229430|NCT00553683|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Poly ICLC may~     stop the growth of liver cancer by blocking blood flow to the tumor. Giving the drug directly~     into the arteries around the tumor may kill more tumor cells. Giving cyclophosphamide and~     radiation therapy together with poly ICLC may be an effective treatment for liver cancer.~      PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide,~     radiation therapy, and poly ICLC together and to see how well they work in treating patients~     with unresectable, recurrent, primary, or metastatic liver cancer.~   "
229431|NCT00553670|"~     Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the~     field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in~     the main brach, it increases the side branch's stenosis degree. However, its mechanism and~     incidence are not known. This study will be performed to search for the mechanism and~     incidence of that phenomenon.~   "
229432|NCT00553657|"~     The purpose of this study is to determine if standardizing fluid intake in a clinic setting~     will reduce variability of individual voiding parameters and potentially serve as a way to~     limit patient exposure in the initial assessment of efficacy of compounds being developed for~     Overactive Bladder.~   "
229433|NCT00553644|"~     This phase II trial studies how well bortezomib and lenalidomide work in treating patients~     with mantle cell lymphoma that has come back after a period of improvement (refractory) or is~     not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells~     by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune~     system to kill cancer cells and may also block the growth of new blood vessels necessary for~     cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed~     or refractory mantle cell lymphoma.~   "
229434|NCT00553631|"~     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme~     glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside~     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ~     system dysfunction. The purpose of this non-inferiority study is to evaluate the efficacy and~     safety of GA-GCB (velaglucerase alfa) administered every other week in comparison to~     imiglucerase in treatment naive patients with type 1 Gaucher disease.~   "
229435|NCT00553618|"~     The purpose of this study is to see if the combination of the two cancer drugs, Dacarbazine~     (DTIC) and a low-dose of Proleukin (IL2), would provide a less toxic and more effective~     treatment for melanoma than currently available treatments for people with high-risk~     melanoma. Dacarbazine (DTIC) and Proleukin (IL2) are both FDA-approved drugs for the~     treatment of melanoma.~   "
229440|NCT00553553|"~     The patient population requiring hepatic resection can demonstrate an unpredictable risk of~     exhibiting peri-operative coagulopathy resulting either from the pre-operative hepatic~     pathophysiology or volume of parenchymal resection. Choice of analgesia can be severely~     limited.~      Currently, the most commonly described use of combined remifentanil infusion and intrathecal~     morphine has been in fast-track cardiac surgery. To date, there are no published data~     describing its use in the context of major hepatobiliary where the investigators predict it~     may provide adequate analgesia with a lower rate of adverse effects over the first 24 hours~     after surgery.~   "
229441|NCT00553540|"~     The purpose of this study is to determine whether orthopedic spinal supports are effective in~     the treatment of low back pain.~   "
229442|NCT00553527|"~     The purpose of this prospective clinical data collection is to document the performance and~     clinical outcomes of Biomet Humeral Stems.~   "
229443|NCT00553514|"~     This is a Phase 2, interventional, multi-center, randomized, assessor-blind,~     active-comparator, dose-finding study to evaluate a new investigational long-acting follicle~     stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI).~     This study will compare 4 doses of the investigational drug versus a currently marketed drug~     follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.~   "
229444|NCT00553501|"~     RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Giving~     epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin~     lymphoma.~      PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab~     works in treating patients with previously untreated follicular non-Hodgkin lymphoma.~   "
229445|NCT00553488|"~     This study is to determine the effect of intra-dermal (ID) administration of regular and of~     rapid-acting insulin, before eating, on blood glucose levels for several hours after a~     standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously,~     for control or comparison purposes. The hypothesis or expectation is that ID insulin will~     work more quickly and control blood glucose levels better than SC injection.~   "
229446|NCT00553475|"~     To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in~     patients with painful diabetic peripheral neuropathy.~   "
229447|NCT00553462|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized~     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation~     therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation~     together with radiation therapy and erlotinib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel~     albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib~     works in treating patients with stage III non-small cell lung cancer that cannot be removed~     by surgery.~   "
229448|NCT00553449|"~     The purpose of this study is to evaluate the effect of each of the rabeprazole treatment~     regimens on nocturnal heartburn symptoms.~   "
229449|NCT00553436|"~     The purpose of this study is to show that the surgical site in the bowel wall can be sewn~     closed in the colon or intestine, with a new sewing device after removal of a benign polyp~     according to standard of care.~   "
229450|NCT00553423|"~     To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy~     (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients~   "
229451|NCT00553410|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast~     cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen~     of letrozole is more effective in postmenopausal women who have received hormone therapy for~     early-stage breast cancer.~      PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in~     preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for~     hormone receptor-positive, lymph node-positive, early-stage breast cancer.~   "
229452|NCT00553397|"~     The use of live donors for solid organ transplantation has increased the number of available~     organs for those waiting for a transplant. Donation of an organ may have significant effects~     on a donor's health. This study will determine the baseline characteristics, early~     postoperative morbidity, and long-term survival for participants who underwent donor~     lobectomy between 1993 and 2006.~   "
229453|NCT00553384|"~     The reason for doing this research is to understand why different people show different~     responses when they smell an odor called androstadienone. Androstadienone is a chemical found~     in male sweat. Other studies have shown that smelling this chemical can cause people to~     experience sweating, changes in skin temperature, and changes in a stress hormone call~     cortisol. These responses, which are called physiological effects, are stronger in some~     people than in others.~      We are interested in finding out whether these individual differences are genetic, that is~     caused by differences in our genes. Humans have about 1000 genes for odorant receptors. These~     are the molecules that bind and detect odor molecules in our nose and allow us to respond to~     so many different odors. It has been shown that some of these genes exist in two forms: a~     functional one and one that has been mutated and is therefore no longer functional.~      We think that people who do not respond to a specific odor may carry the non-functional form~     of the gene for the receptor that detects the odor molecule. To test this idea we want to~     find people who respond strongly to a specific smell, and compare their odorant receptor~     genes with those of people who respond weakly to the odor.~   "
229454|NCT00553371|"~     RATIONALE: Learning about long-term effects in patients with testicular cancer may help~     doctors plan better treatment and follow-up care.~      PURPOSE: This clinical trial is using CT scans to follow patients who have been treated for~     metastatic testicular cancer.~   "
229479|NCT00553046|"~     To verify with a specific questionnaire, the families' perceived quality of end-of-life care~     and of dying in the last 3 months of life of 168 patients (Chronic Obstructive Pulmonary~     Disease-Amyotrophic Lateral Sclerosis (ALS)-Restrictive disorders-Neuromuscular disease-~     others) with chronic respiratory failure needing domiciliary mechanical ventilation (MV).~   "
229455|NCT00553358|"~     This is a randomised, open label multicenter Phase III study comparing the efficacy of~     neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant~     lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2~     over-expressing and/or amplified primary breast cancer.~      Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg~     intravenous (IV) load followed by 2 mg/kg IV weekly, or lapatinib 1000 mg daily with~     trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for a total of 6 weeks. After this~     biological window, patients on monotherapy arms will continue on the same targeted therapy~     plus weekly paclitaxel 80 mg/m^2 for a further 12 weeks, up to definitive surgery. In the~     combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab~     2 mg/kg IV plus weekly paclitaxel 80mg/m^2 IV for a further 12 weeks, up to definitive~     surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with~     5-Fluorouracil Epirubicin Cyclophosphamide (FEC) followed by the same targeted therapy as in~     the biological window of the neoadjuvant setting for a further 34 weeks (in the combination~     arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total~     duration of the anti-HER2 therapy will be one year.~   "
229456|NCT00553345|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of selenium and vitamin E may stop cancer from growing or coming back.~      PURPOSE: This randomized phase III trial is studying giving selenium together with vitamin E~     to see how well it works compared with a placebo in preventing cancer progression and~     recurrence in patients with early-stage bladder cancer.~   "
229457|NCT00553332|"~     This phase II trial is studying how well selumetinib works in treating patients with biliary~     cancer that cannot be removed by surgery. Selumetinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
229458|NCT00553319|"~     The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the~     safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine~     dependence. Since this medication has independently shown promise in helping with ADHD and~     cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD~     and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives~     of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and~     improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.~   "
229459|NCT00553306|"~     RATIONALE: Laboratory-treated T cells may be able to kill tumor cells when they are put back~     into the body. Aldesleukin and cyclophosphamide may stimulate the immune system in different~     ways and stop tumor cells from growing. Giving laboratory-treated T cells together with~     aldesleukin after cyclophosphamide may be an effective treatment for melanoma.~      PURPOSE: This phase I/II trial is studying the side effects of giving laboratory-treated T~     cells together with aldesleukin after cyclophosphamide and to see how well they work in~     treating patients with stage IV melanoma.~   "
229460|NCT00553293|"~     To study whether addition of human LH hormone (Luveris) during the final days of stimulation~     with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for~     patients undergoing in vitro fertilisation.~   "
229461|NCT00553280|"~     The purpose of this study is to assess the safety and efficacy of the long-term use of~     pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy~     who have completed 13 weeks of dosing in Study A0081163~   "
229462|NCT00553267|"~     The primary objective of this trial is to demonstrate that the fixed dose combination of~     telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan~     80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks~     compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks~     treatment with A10.~   "
229463|NCT00553254|"~     To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.~   "
229464|NCT00553241|"~     The purpose of this study is to determine whether the ABCD2 score can be used in patients~     with transient ischemic attack, admitted to Beijing anzhen hospital, to evaluate the~     prognosis, risk factor of those patients.~   "
229465|NCT00553228|"~     The purpose of this study is to assess whether immunization against pertussis in the mid~     third trimester of pregnancy provides passive protection to the infant by transfer of IgG~     transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk,~     sufficient to protect the infant against pertussis disease in the critical neonatal period,~     without suppressing the infant's immune response to active immunization and disease~   "
229466|NCT00553215|"~     RATIONALE: Studying quality of life in patients with bladder cancer may help determine the~     long-term effects of bladder cancer and may help improve the quality of life for patients in~     the future.~      PURPOSE: This clinical trial is studying quality of life in patients with bladder cancer.~   "
229467|NCT00553202|"~     RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that~     closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops~     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving antithymocyte globulin before~     transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may~     stop this from happening.~      PURPOSE: Natural Killer (NK) cells from the donor's bone marrow may be important in fighting~     leukemia. Bone marrow donors can be selected based on the type of NK cells they have,~     specifically the killer immunoglobulin receptor (KIR) type. This study provides information~     on KIR type from potential donors, which can be used in selecting the bone marrow donor. This~     phase II trial of unrelated donor stem cell transplant in patients with high risk AML~     (monosomy 7, -5/5q-, high FLT3-ITD AR, or refractory or relapsed AML) in which KIR typing of~     the patients and potential donors will be available to the treating transplant physician at~     the time of donor selection.~   "
229480|NCT00553033|"~     The aim of this study is to evaluate the feasibility and safety of laparoscopic liver~     surgery.~   "
229481|NCT00553020|"~     To assess the duration of the metabolic effect of a sc injected single dose of either insulin~     glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type~     2 diabetes~   "
229468|NCT00553189|"~     Background:~        -  PARP is an enzyme that is involved in the repair of damage to DNA. Levels of the enzyme~          are higher in tumor cells than in normal cells, and may play a part in resistance to~          cancer chemotherapy and radiation therapy. ABT-888 is an experimental drug that inhibits~          PARP and may help to increase the effectiveness of cancer treatments designed to damage~          DNA in cancer cells.~        -  Topotecan is a drug approved by the Food and Drug Administration for treating certain~          cancers.~        -  This dose escalation study will test the two drugs at successively higher doses in small~          groups of patients until the highest safe dose is determined.~      Objectives:~        -  To test the safety of the combination of ABT-888 and Topotecan (TPT) and determine the~          highest dose of each drug that can be safely given to humans. This is the maximum~          tolerated dose (MTD).~        -  To learn how the combination of ABT-888 and TPT works in humans and how the body handles~          the drugs.~        -  To determine the side effects of the combination of ABT-888 and TPT at the tested doses.~      Eligibility:~      -Patients with solid tumors, lymphomas and chronic lymphocytic leukemia whose disease has~     progressed following standard therapy or for whom standard treatments are not available.~      Design:~        -  ABT-888 and TPT are given in 21-day treatment cycles. At the start of the study, TPT is~          infused through a vein over 30 minutes about a week before cycle 1 starts. Starting on~          day 1 of cycle 1, ABT-888 is given by mouth twice a day for 7 days. TPT is given through~          a vein daily for 4 days starting on day 2. After the last dose of ABT-888 day 7, no more~          treatment is given for the rest of the 21-day cycle.~        -  For the remaining cycles, ABT-888 is given twice a day by mouth on days 1 to 7 of each~          cycle, and TPT is given through a vein daily on days 1 to 5 of each cycle.~        -  The first three to six patients enrolled in the study take the smallest study dose of~          the drugs. If they do not develop significant adverse side effects, successive small~          groups of patients take the drug at increasingly higher doses until the MTD is reached.~          Additional patients enrolled receive the MTD.~        -  Patients have periodic clinic visits for their TPT infusions and for tests and~          examinations. Evaluations include measurement of vital signs, physical examinations,~          blood and urine tests, electrocardiograms and CT or other imaging tests, such as~          ultrasound or MRI. Tumor biopsies may be requested to study the effects of the drugs on~          the...~   "
229469|NCT00553176|"~     The purpose of this study is to evaluate the long-term clinical, economic and humanistic~     outcomes of various treatment regimens, including infliximab, in Crohn's disease in real~     world medical practice.~   "
229470|NCT00553163|"~     There is increasing evidence that worsening of ulcerative colitis (UC) can be provoked by~     psychological stresses. As yet, there have been no proper scientific studies to find out~     whether stress reduction can improve the course of UC. Hypnotherapy is a technique by which a~     practitioner induces a temporary trance-like state in patients: while they are in this state,~     the practitioner uses suggestion to induce relaxation as well as beneficial modification of~     the way in which the patient experiences the gut working. In previous studies in our lab, we~     have shown that a single 50 minute session of hypnosis can reduce special indicators of~     inflammation both in the blood-stream and in the lining of the lower bowel (rectum). Further~     more, in earlier work by others, hypnosis has been shown to be effective in the treatment of~     patients with irritable bowel syndrome, duodenal ulcer and indigestion unassociated with~     ulcers.~      Many patients with UC need to take the immunosuppressive drug, azathioprine, in addition to a~     5ASA drug, to keep their disease under control. While azathioprine is usually effective in~     maintaining remission of UC, it does require regular drug checks and carries the risk of~     possible side-effects. We now plan to undertake a study of hypnotherapy to see whether it can~     prevent relapse (worsening) of UC in patients who normally need to take azathioprine to keep~     their UC inactive. To do this, we shall ask 66 patients who agree to participate in the trial~     to stop their azathioprine. They will then be allocated to receive either gut-focussed~     hypnotherapy (44 patients) or, as a control, non-emotive educational sessions (22 patients)~     once a month for 3 months, with intervening self-hypnosis daily in the active arm. We shall~     then record the numbers of patients in each group who develop relapse of their UC after 6~     months and after a year. We shall diagnose relapse from patients' own diaries recording~     diarrhoea and bleeding, and by sigmoidoscopy. As part of these studies, we shall also do~     particular blood tests and take specimens from the lining of the rectum during the~     sigmoidoscopy to assess by special laboratory testing how hypnotherapy might be working to~     reduce inflammation in the bowel.~      It is hoped that this clinical trial will identify a new drug-free way of reducing the~     chances of relapse in patients with UC. It should also shed further light on the ways in~     which the brain can affect the function of the inflamed bowel~   "
229471|NCT00553150|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking some of the blood flow to the tumor. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving everolimus together with temozolomide and~     radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when~     given together with temozolomide and radiation therapy in treating patients with newly~     diagnosed glioblastoma.~   "
229472|NCT00553137|"~     A prospective randomized double blinded placebo controlled comparative trial will be~     performed at HIV clinic of the Muhimbili National Hospital/MUCHS where 220 HIV positive~     patients presenting with oropharyngeal candidiasis (OPC) on antiretroviral (ARVs) treatment~     or not will be included.~      The aim of this study is to compare the efficacy and safety of single dose fluconazole~     (750mg) and two weeks course of fluconazole (150mg once daily)in the treatment of OPC in HIV~     positive patients. It is hypothesised that the two regimens are equally effective in the~     treatment of OPC.~   "
229473|NCT00553124|"~     RATIONALE: Studying different factors that effect patients with newly diagnosed bladder~     cancer may help doctors learn more about the disease, improve the ability to plan cancer~     treatment, and help patients live more comfortably.~      PURPOSE: This clinical trial is studying different factors affecting patients with newly~     diagnosed bladder cancer.~   "
229474|NCT00553111|"~     During the winter of 2007, the Syphilis Advisory Group and Bureau of STD Control of the NYC~     Department of Health funded the Emergency Department of Jacobi Medical Center to further~     evaluate the effectiveness of the Syphilis and Men video in additional settings where men~     access STD related information and testing and where high-risk groups, such as MSM, frequent.~     The video was evaluated for promoting knowledge of syphilis, especially as facilitator of HIV~     transmission, and in encouraging concurrent testing (syphilis and HIV) among men recruited~     from a community-based organization, an ambulatory care setting, and a dance club.~   "
229475|NCT00553098|"~     This phase II trial studies fludarabine phosphate and total-body irradiation with or without~     alemtuzumab followed by donor stem cell transplant to see how well it works in treating~     patients with immunodeficiency or other nonmalignant inherited disorders. Giving~     chemotherapy, such as fludarabine phosphate, a monoclonal antibody such as alemtuzumab, and~     radiation therapy before a donor stem cell transplant helps stop the growth of abnormal~     cells. It may also stop the patient's immune system from rejecting the donor's stem cells.~     The donated stem cells may replace the patient's immune cells and help destroy any remaining~     abnormal cells.~   "
229476|NCT00553085|"~     The main objective of the study is to examine the relationship between anxiety disorders and~     neurodevelopmental disorder/delay in children aged 7- 13 years.~   "
229477|NCT00553072|"~     Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that~     magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in~     the immediate neonatal period.~   "
229478|NCT00553059|"~     The goal of this clinical research study is to learn if adding dronabinol in combination with~     the standard of care (dexamethasone and palonosetron) can better help to control nausea and~     vomiting in patients receiving chemotherapy. The safety of the drug combinations will also be~     studied.~   "
229484|NCT00552981|"~     In a randomized controlled trial, the investigators include patients with beginning symptoms~     of a common cold and compare two interventions:~        1. the inhalation of warm air for inducing a warming of the throat and~        2. the inhalation of ambient air as control. As outcome the effect on symptoms and duration~          of the common cold will be assessed. The interventions will consist of visits with a~          duration of 2-3 minutes on three following days in a Finnish sauna. Patients will be~          fully dressed.~   "
229485|NCT00552968|"~     The incidence of pain in the post traumatic population is an area that has little to no~     investigation. This study seeks to determine the incidence and experience of pain in this~     vulnerable population at different time points - while in hospital, 4 weeks post injury, 3~     months post injury.~   "
229486|NCT00552955|"~     This study will examine the effect of fasting on lymphangioleiomyomas abdominal tumors formed~     from enlarged lymph nodes containing lymphatic fluid. Previous studies have determined that~     these tumors increase in size in the evening, but this result could stem from the fact that~     previous study participants were tested after eating lunch. The purpose of the study is to~     help researchers understand the factors that produce changes in size of lymphangioleiomyomas,~     as well as to improve the ability of medical professionals to diagnose lymphangioleiomyomas~     and avoid confusing these tumors with other malignant tumors.~      Volunteers must be women who are at least 18 years of age and who have been diagnosed with~     lymphangioleiomyomas in the abdominal or pelvic areas. Candidates who have had lung or kidney~     transplants or who have type 1 diabetes will be excluded. Candidates will be screened with a~     physical examination and medical history.~      During the study, participants will be admitted to a National Institutes of Health clinical~     center for three days to undergo a number of tests. Tests will include routine blood and~     urine tests, and electrocardiogram, research blood testing, and abdominal and pelvic~     ultrasounds....~   "
229487|NCT00552942|"~     To see if removing the omentum in addition to a gastric bypass improves diabetes is better~     than just a gastric bypass.~   "
229488|NCT00552929|"~     The objective of the trial was to establish the dose-response relation of Org 25969 given as~     a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for~     Caucasian subjects~   "
229489|NCT00552916|"~     The purpose of this study is to determine if a form of exercise,known as electrical~     stimulation can improve walking function and other important health outcomes. The hypothesis~     is that electrical stimulation can enhance the ability to walk for stroke survivors who are~     unable to walk on their on their own.~   "
229490|NCT00552903|"~     A randomised trial with individual patients as units of observation will be carried out.~     Health coaching is used to modify health behaviour and thus improve disease control and~     health status, as well as use of health care services. A personal health coach is assigned to~     each patient and they are in weekly contact through telephone. The intervention lasts for 12~     months. No intervention is offered to the patients in the control arm.~   "
229491|NCT00552890|"~     This randomized control trial compared the influence of an Atkins diet to that of the ADA~     recommended diet on Type 2 diabetic obese patients during a one-year follow-up period~   "
229492|NCT00552877|"~     In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher~     Select+ coronary stents in the treatment of unselected patients with coronary artery disease.~   "
229493|NCT00552864|"~     In High Thoracic Epidural Anesthesia (HTEA) the use of a local anesthetic (LA) with low~     cardiac toxicity is crucial as myocardial contractility is often already seriously impaired.~     The aim of this study is to compare the efficacy, doses and side effects of ropivacaine and~     levobupivacaine in patients submitted to coronary artery bypass graft with HTEA and general~     anesthesia. The primary end point is the amount of LA drug required to maintain a VAS < 4~     when coughing in the first 24 postoperative hours.~   "
229494|NCT00552851|"~     The purpose of this study is to evaluate changes in left ventricular mass and cardiac~     function in patients with active acromegaly before and after treatment with the growth~     hormone receptor antagonist pegvisomant for one year.~   "
229495|NCT00552838|"~     Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as an effective~     mechanism for improving antimicrobial use, but data on their efficacy remain limited. The~     researchers postulated that a multi-disciplinary AUT would improve antimicrobial use in a~     teaching hospital when compared to the standard of care (no AUT intervention).~      Design: Randomized-controlled intervention trial. Setting: A 953-bed urban teaching hospital.~      Patients: Patients admitted to internal medicine ward teams who were prescribed selected~     antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) during the~     10month study period.~      Intervention: Eight internal medicine ward teams were randomized monthly to academic~     detailing by the AUT while 8 internal medicine ward teams were randomized indication-based~     prescription of broad spectrum antimicrobials.~      Measurements: Proportion of appropriate empiric, definitive, and end antimicrobial usage~     (antimicrobial use from the initiation of therapy until definitive therapy is prescribed).~   "
229496|NCT00552825|"~     The aim of this study was to investigate the occurrences of respiratory symptoms risk factors~     and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic~     diseases at presentation (before treatment) and up to 3 years follow-up (study period).~   "
229497|NCT00552812|"~     The purpose of this study is to determine whether Cheatham Platinum bare metal stents are~     safe and effective in the treatment of native and recurrent aortic coarctation in selected~     children, adolescents and adults.~   "
229498|NCT00552799|"~     To assess whether a period of prophylactic penicillin after an episode of cellulitis of the~     leg reduces the risk of repeat episodes. Participants are randomised to receive 12 months of~     prophylaxis (penicillin VK 250mg b.d. or placebo). The PATCH I study will recruit only~     patients with recurrent disease.~   "
229499|NCT00552786|"~     This study will examine whether oral intake of 1200mg N-Acetylcysteine/day will prevent~     temporary threshold shift in hearing among workers exposed to noise~   "
229500|NCT00552773|"~     To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to~     placebo in subjects with acute sinusitis~   "
229501|NCT00552760|"~     The purpose of this study is to determine whether treating sleep difficulties in patients~     with bipolar disorder also improves their mood stability.~   "
229502|NCT00552747|"~     Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and~     decreasing triglyceride levels. The interaction with these receptors has antiatherogenic~     actions by regulating the expression con key proteins that participate in vascular~     inflammation, plaque stability and thrombosis.~      Fenofibrate reduces triglycerides and increases HDL-C in plasma. It also decreases small,~     dense LDL particles. The use of this drug has resulted in improvement of vascular function~     measured by endothelial function. Our hypotheses state that fenofibrate will improve:~     endothelial function, improve HDL antioxidant capacity and size distribution towards a~     predominance of small HDL particles.~   "
229503|NCT00552734|"~     140 subjects will be enrolled into the clinical study and randomized into the Control Group~     or the Experimental Group by block randomization. The subjects must meet all inclusion and~     none of the exclusion criteria. Each subject will have 7 clinic visits and 3 phone visits.~     The Baseline Visit will consist of a complete history, vitals, a physical examination and~     completion of the consent and screening process. All clinic visits, except for the Baseline~     Visit will include meter/PDA download. In addition, meter education will be provided to all~     subjects, and PDA education will be provided to the Experimental group at the Baseline Visit~     and 2-Week Visit as needed to ensure subject understanding. The phone visits will consist of~     a history including any changes in insulin dose, and any hypoglycemic events, hyperglycemic~     events, or other adverse events that have occurred since the last clinic visit.~      The primary endpoint in this study was to show a reduction in A1c of at least 0.4% or higher~     in the insulin guidance software group at 6 months and/or 1 year.~   "
229504|NCT00552721|"~     It is the primary purpose of this pilot study to investigate if physical therapy with~     strength training is better at improving muscle and gait function after anti-spastic~     treatment with Botulinum toxin compared to physical therapy without strength training in~     children with cerebral palsy. The investigators hypothesize that it is.~   "
229505|NCT00552708|"~     This study will be a randomized study investigating the bioequivalence of COREG CR to its~     components, COREG and Lisinopril (ZESTRIL). PK samples will be obtained throughout the study~     to investigate the PK of COREG CR FDC to COREG and Lisinopril~   "
229506|NCT00552695|"~     This study will determine whether application of a patch containing a topical anesthetic~     (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an~     intravenous catheter in Emergency Department patients.~   "
229507|NCT00552682|"~     The purpose of this study is to compare duloxetine with conventional treatment of pain in~     HIV-1 infected patients.~   "
229508|NCT00552669|"~     In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare~     metal stent implantation alone demonstrated at one year of follow up a significant reduction~     of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June~     2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries~     from our group with Drug Eluting Stents showed similar amount of reduction in clinical~     parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention~     2006,2:53-60). Taking in account that 8.3% of patients treated with oral rapamycin plus Bare~     Metal Stents(ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical~     restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare~     differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of~     follow up assuming that safety and efficacy clinical end points would be similar.~   "
229509|NCT00552656|"~     The purpose of this study is to investigate the long term efficacy and safety of firebird~     sirolimus-eluting stent for treatment of complex coronary Lesions.~   "
229510|NCT00552643|"~     The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline~     in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic~     chronic wounds with different etiologies including wounds with exposed bone and/or tendons.~   "
229511|NCT00552630|"~     Childhood Lead Poisoning is a widespread disease that has few effective treatments. The~     specific aims of this proposed clinical trial are threefold:~        -  To determine whether a six-week course of a newly formulated d-penicillamine suspension~          will effectively reduce blood lead level in children aged 6 months to 16 years with~          blood lead levels of 15-25 μg/dL.~        -  To determine whether d-penicillamine chelation produces a sustained reduction in blood~          lead level in comparison with succimer and other lead chelators which always produce a~          significant post-treatment rebound.~        -  To determine whether chelation with d-penicillamine improves the physiologic~          disturbances that can be measured in children with blood lead levels in this range.~   "
229512|NCT00552617|"~     The objective of the trial was to establish the dose-response relation of Org 25969 given as~     a reversal agent of rocuronium or vecuronium at reappearance of T2 during sevoflurane~     anesthesia for Caucasian subjects.~   "
229513|NCT00552604|"~     Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis~     sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness~     and pain in multiple sclerosis for a period of 12 weeks.~      Study Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during~     previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised~     ≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at~     baseline.~      Study treatment:~      Group 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing~     between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous~     antispasticity and analgesic medication.~      Group 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic~     medication.~      Treatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg~     THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on~     tolerability. Treatment duration: 12 weeks.~      Study sites: 20 neurological clinics in the United Kingdom.~   "
229563|NCT00551928|"~     To compare the efficacy of the combination of lenalidomide with low-dose melphalan versus~     high-dose melphalan in newly diagnosed, symptomatic MM patients.~   "
229724|NCT00549809|"~     Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent~     mandatory ventilation associated with pressure support (SIMV/PS) related to duration of~     mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical~     trial. Setting: Pediatric intensive care unit at a university-affiliated hospital.~   "
229514|NCT00552591|"~     Background: Family members (spouses, siblings, offspring) of patients with coronary heart~     disease (CHD) may themselves be at increased risk for developing CHD for genetic, biochemical~     and/or behavioural reasons. Targeted approaches aimed at family members of those with~     established CHD may be a cost-effective way to identify high-risk persons and link them to~     effective risk factor modification. During pilot testing we found 29% of family members of~     patients recently hospitalized at our institution had ≥ 3 CHD risk factors. Encouragingly,~     they indicated high levels of readiness to change underlying risk behaviours such as~     cigarette smoking and physical inactivity. We have developed a 12-week family heart health~     program featuring a personal plan for achieving risk factor goals and weekly contact with a~     heart health educator. This intervention needs to be fully tested.~      Research Aims:~      In this study, we will:~        1. Compare the effects of a targeted family heart health (FHH) screening, counselling and~          follow-up program versus usual care (UC) for reducing participants total~          cholesterol/high density lipoprotein (TC/HDL) ratio 52 weeks after program entry, in~          family members of patients recently hospitalized with CHD;~        2. Compare the effects of the FHH program versus UC on modifiable components comprising the~          Framingham score, including: smoking status; systolic blood pressure; total cholesterol;~          and high density lipoprotein cholesterol;~        3. Compare the effects of the FHH program versus UC on: lifestyle-related factors (dietary~          patterns, leisure time exercise, body composition); medication use (anti-lipemic~          medications, anti-hypertensive medications, pharmacotherapies for smoking cessation);~          and use of healthcare resources (physician visits, hospitalization days, number of~          laboratory and diagnostic tests and procedures).~   "
229515|NCT00552578|"~     This study is designed to determine if different doses of buprenorphine (either tapering~     doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who~     also are addicted to opiate pain medicines.~   "
229516|NCT00552565|"~     The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in~     the treatment of IBS-D.~   "
229517|NCT00552552|"~     The objective of this study is to develop a structured and evidence-based self-management~     program to cope with cancer-related fatigue and to assess the efficacy of the intervention in~     cancer survivors.~   "
229518|NCT00552539|"~     The objective of this study is to determine whether the Syphilis and Men educational video~     can be a useful tool to increase syphilis knowledge and testing among English and~     Spanish-speaking urgent care and emergency department patients, regardless of various~     self-reported characteristics that increase their risk for syphilis infection.~   "
229519|NCT00552526|"~     This is an open randomized controlled study in children with mental retardation and~     refractory epilepsy in which treatment with ketogenic diet (KD) is compared with treatment~     with the antiepileptic drug (AED), not tried by the patient before, which we consider to be~     the most appropriate AED for the patient.~   "
229520|NCT00552513|"~     The timing of intervention study is a prospective, randomized, international, multicentre~     comparison of the relative efficacy, safety, and cost effectiveness of a management strategy~     of coronary angiography and intervention performed within 24 hours of randomization versus~     delayed coronary angiography and intervention in patients after 36 hours with acute coronary~     syndromes (ACS).~   "
229521|NCT00552500|"~     This project aims to a) evaluate the effects of haloperidol, olanzapine, and risperidone in~     combination with valproate on insulin secretion and insulin actions, b) evaluate medication~     effects on abdominal fat, total body fat and total fat-free mass, and c) evaluate treatment~     effects on glucose tolerance, lipid profiles, and plasma levels of leptin, adiponectin,~     ghrelin and C-reactive protein. Hypotheses will be evaluated by measuring 1) insulin action~     and secretion using frequently sampled intravenous glucose tolerance tests, 2) body~     composition using dual energy x-ray absorptiometry, magnetic resonance scans, and~     anthropomorphic measurements, and 3) changes in hormone levels and lipid profiles. The aims~     will be addressed in non-diabetic schizophrenia patients chronically treated with~     haloperidol, olanzapine or risperidone who will have valproate added to their treatment.~     Relevant data is critically needed to target basic research, identify long-term~     cardiovascular risks, and plan therapeutic interventions.~   "
229522|NCT00552487|"~     The purpose of this study is to determine whether patients with Hashimoto thyroiditis and~     impaired well-being may have a partial secondary adrenocortical insufficiency.~   "
229523|NCT00552474|"~     The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of~     the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain~     Stimulation System as an adjunctive treatment for reducing some of the symptoms of~     Parkinson's Disease that are not adequately controlled with medication.~   "
229524|NCT00552461|"~     The purpose of this study is to determine whether the use of rituximab is effective in~     treating pulmonary alveolar proteinosis by leading to an improvement in lung function and~     disease status.~   "
229525|NCT00552448|"~     Asthma is a disease resulting in mucus hypersecretion and airways obstruction. This causes~     difficulty breathing. The High Frequency Chest Compressor (HFCC) is a device that has been~     shown to decrease respiratory complications in individuals with severe disability who are~     unable to clear airway secretions. There is a lack of studies using this device in children~     with asthma. The device has been shown in a study to be safe in children with asthma. The~     investigators propose that using this device in our pediatric patients hospitalized in the~     pediatric ICU with asthma will result in decreased pediatric ICU stay. The investigators will~     also look at asthma severity, total days of hospital stay and chest discomfort while on~     therapy.~   "
229526|NCT00552435|"~     Objective: To compare micropulse 810nm diode laser photocoagulation versus argon laser~     photocoagulation for treatment of diabetic macular edema. Micropulse laser technique will be~     determined by an initial clinical trial comparing single versus double density laser~     photocoagulation techniques for treatment of diabetic macular edema.The single density is~     based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grid photocoagulation~     technique and the double density increases the number of spots.~      Methods: Patients with diabetic macular edema will be assigned to receive either micropulse~     810nm diode laser photocoagulation or argon laser photocoagulation therapy. First, in a~     smaller clinical trial, patients will be assigned to single or double density micropulse~     810nm diode laser to determine best strategy for this therapy. Visual acuity, fundus~     photographs and fluorescein angiography, and optical coherence tomography measurements ,~     autofluorescence and mfERG were obtained at baseline and at 1, 3 and 6 months and 12 months.~   "
229527|NCT00552422|"~     The purpose of this study is to examine the clinical response to domperidone in solid organ~     transplant recipients with gastroparesis.~   "
229769|NCT00549211|"~     A study conducted on healthy volunteers to determine the safety, tolerability and affect on~     the human body by experimental drug GSK557296.~   "
229528|NCT00552409|"~     This study will assess the effects of vitamin D3 supplementation (cholecalciferol; 2000 IU~     daily) on serum calcium levels, circulating vitamin D levels, and markers of kidney disease~     and cardiovascular risk among people with diabetes mellitus and early kidney disease.~     Eligibility criteria include type 2 diabetes and stage 1-2 chronic kidney disease, defined by~     a urine albumin-creatinine ratio 30-300 mg/g and an estimated glomerular filtration rate ≥ 60~     mL/min. Participants will be randomly assigned to treatment with vitamin D3 or placebo, each~     taken by mouth once daily for a study duration of one year. Study medications will be added~     to standard treatment, including an angiotensin converting enzyme inhibitor and/or~     angiotensin II receptor blocker. We hypothesize that vitamin D3, compared with placebo: (1)~     is well-tolerated and safe among people with diabetes and kidney disease; (2) results in~     adequate attained circulating vitamin D levels; and (3) positively affects markers of kidney~     disease and cardiovascular risk.~   "
229529|NCT00552396|"~     Development of new treatments for diseases such as multiple myeloma is a focus for research.~     The research being conducted is on treatment called Anti-KIR (1-7F9), which activates the~     body's own cells to kill tumor cells. This is different from many other treatments where~     chemicals are given to kill tumor cells. The purpose of the study is to determine a safe dose~     of Anti-KIR (1-7F9) to administer in humans and to gain information about its effectiveness~     in the treatment of multiple myeloma.~   "
229530|NCT00552383|"~     NIDCAP based developmental care is a method of looking after preterm infants that is guided~     by the infant's behavioural cues, and that actively involves parents in the care of their~     infant. There is limited evidence that outcomes for infants are improved if they receive~     NIDCAP based care. This study evaluates the effects of introducing NIDCAP based care to a~     level III neonatal intensive care unit, in the post - surfactant era, and also evaluates its~     effects on developmental outcomes at age 18 months.~   "
229531|NCT00552370|"~     To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®,~     each of varying intensity and defined by their end-of -study target for self monitored plasma~     glucose(SMPG), in patients with Type 2 diabetes mellitus, with inadequate glycemic control~     (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).~   "
229532|NCT00552357|"~     Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days~     after lung transplant surgery. This study will analyze blood samples to determine if high~     levels of certain chemicals may increase the risk of developing PGD after a lung transplant.~   "
229533|NCT00552344|"~     The primary objective of the study is to assess the safety of long term therapy with~     Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].~   "
229534|NCT00552331|"~     The purpose of this study is to determine whether the rate of fracture healing and fracture~     union, repaired with the LISS device, will be as good as or better than the usual fracture~     fixation systems.~   "
229535|NCT00552305|"~     The purpose of this trial is to determine whether lacosamide is safe and effective for~     long-term use in patients with partial-seizures from epilepsy.~   "
229536|NCT00552292|"~     The study in aimed to investigate epidemiology of risk factors in Russian Federation its~     prognostic value aimed on acceptance of national specific definition of metabolic syndrome~     and guidelines for its management.~   "
229537|NCT00552279|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and~     safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an~     alternative dosing schedule as compared to the standard dosing schedule in young female~     subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with~     the FDA Amendment Act, Sep 2007.~   "
229538|NCT00552266|"~     This study will evaluate the safety and effectiveness of methylphenidate in treating~     attention deficit hyperactivity disorder (ADHD) in children with both ADHD and~     trichotillomania.~      Trichotillomania is an impulse control disorder. There is growing evidences of the~     involvement of dopaminergic neurotransmission in the pathophysiology of trichotillomania.~     Reported increase in the prevalence of ADHD among patients with impulse control disorders,~     such as pathological gambling as well as trichotillomania, may result from the overlapping~     pathophisiological background. It is hypothesized that in cases of ADHD comorbid with~     trichotillomania methtylphenidate treatment will exhibit beneficial effects in both the ADHD~     and the hair pulling.~   "
229539|NCT00552253|"~     We will study the effect of taking eltroxin at different time, i.e. fasting or postprandial~     periods. We will also study the effect of levothyroxin treatment in Chinese people~   "
229540|NCT00552240|"~     The aim of this clinical trial is to compare the efficacy and safety of ritonavir~     (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir~     disoproxil fumarate (DF).~   "
229541|NCT00552227|"~     The purpose of this study is to determine whether ruboxistaurin can reduce blood vessel~     inflammation associated with diabetes.~   "
229542|NCT00552214|"~     The purpose of this study is to validate the performance characteristics of an assay that~     tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration~     submission.~   "
229543|NCT00552201|"~     Renal transplantation is the treatment of choice of the chronic renal insufficiency arrived~     at its final stage. Tacrolimus is an immunosuppressant treatment used for the prevention of~     episodes of acute rejection. Tacrolimus is characterized by a narrow therapeutic index and~     important interindividual variations of its pharmacokinetic characteristics. Proteins CYP3A4~     and CYP3A5 are responsible of intestinal and hepatic metabolism of Tacrolimus. Various~     polymorphisms for CYP3A5 and CYP3A4 were described and several retrospective studies~     suggested an association between a genetic polymorphism of CYP3A5 and the pharmacokinetic~     parameters of Tacrolimus. In particular, we showed that the presence of an allele CYP3A5*1~     was associated to the use of more important amounts of Tacrolimus to obtain the desired blood~     concentrations.~      This study is a national, multicentric, prospective, opened, randomized on two arms of~     treatment. 280 receivers of a renal transplant in 12 centres will be included. The genotyping~     of gene CYP3A5 will be carried out in the 6 days following transplantation. During the first~     week, the patients will be treated by basiliximab, MMF and corticosteroids. They will be~     randomized (central randomization) in D6 to receive either Tacrolimus at 0.2 mg/kg/d, or at a~     dosage adapted to their genotype. After determination of the first residual blood~     concentration of Tacrolimus realized after six oral intakes, the daily amounts of Tacrolimus~     could be modified if necessary to reach the desired blood concentrations. The total duration~     of the study for a patient is 3 months after transplantation.~      The objective of this study is to evaluate the impact of the adaptation, according to the~     genotype of the CYP3A5 of the patient, of the first amount of Tacrolimus on the first~     residual blood concentration of Tacrolimus, keeping in mind the aim of the individualization~     of dosage schedule by pharmacogenetic approach.~      Principal criterion : Comparison, between the two groups, of the percentage of patients for~     whom the first blood concentration of Tacrolimus evaluated 3 days (D10) after the first~     administration of Tacrolimus ranges between 10 and 15 ng/ml.~      Statistics will be carried out in intention to treat. The principal criterion will be~     analyzed by the test of chi-2.~   "
229546|NCT00552162|"~     Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert~     surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving~     area of preclinical research and several groups worldwide are developing this surgical~     approach together with industry support. In this new surgical technique, abdominal operations~     are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal~     cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of~     minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall~     and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any~     visible scar and could also potentially reduce post operative pain due to the elimination of~     abdominal wall trauma.~      In this trial we intend to operate healthy women who need to undergo cholecystectomy or~     appendectomy. The operations will be performed through the vagina as the access port to the~     peritoneum and it will be monitored with laparoscopic vision for safety reasons.~   "
229547|NCT00552149|"~     A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin~     Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.~   "
229548|NCT00552136|"~     The purpose of this study is to see if the clinical outcome success rate of Total Ankle~     Arthroplasty is similar to that of Ankle Arthrodesis over a period of 10 years. This will~     include looking at whether Total ankle arthroplasty results in a lower rate of hindfoot~     arthrosis and arthritis after surgery compared to ankle joint arthrodesis and if the rate of~     complications and revision surgery is acceptable when compared to Ankle Arthrodesis over a~     period of 10 years.~   "
229549|NCT00552110|"~     The primary objective of this study is to evaluate the efficacy of the combination of~     mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once~     a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms~     including nasal congestion. The secondary objectives of this study are to evaluate the~     potential of the combination to produce tachyphylaxis and/or rebound congestion, and to~     evaluate the safety of the combination.~   "
229550|NCT00552097|"~     The purpose of the study is to determine whether ezetimibe plus simvastatin will be more~     effective than simvastatin alone in preventing progression of atherosclerosis of the inner~     layer of the carotid artery.~   "
229551|NCT00552084|"~     Atrial fibrillation (AF) is a heart rhythm disorder that usually involves a rapid heart rate.~     People who take fish oil supplements may reduce the risk of a recurrence of AF. This study~     will evaluate the effectiveness of fish oil at decreasing the recurrence of AF and will~     examine the reasons why fish oil may reduce this risk.~   "
229552|NCT00552071|"~     The purpose of this study is to determine the difference in drug levels of Sandostatin after~     IM injection of Sandostatin LAR without ultrasound guidance (as is the standard of care)~     compared to drug levels of Sandostatin after IM injection of Sandostatin LAR with ultrasound~     guidance in subjects with Acromegaly.~   "
229553|NCT00552058|"~     The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing~     clinical remission in patients with moderate to severe Crohn's disease as compared with~     placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.~   "
229554|NCT00552045|"~     The purpose of this study is to collect detailed information about the characteristics and~     genetics of a large number of individuals with epilepsy.~   "
229555|NCT00552032|"~     The purpose of this study is to determine whether 8 weeks treatment with mometasone furoate~     nasal spray (MFNS), twice daily, is safe and effective in treating adenoid hypertrophy in~     children.~   "
229556|NCT00552019|"~     The purpose of this study is to evaluate an assessment of the intraocular pressure with the~     dynamic contour tonometry and the Goldmann applanation tonometry in patients with active~     anterior uveitis.~   "
229557|NCT00552006|"~     In the aftermath of traumatic experiences like natural disasters or man-caused traumatic~     events, such as war experiences, a substantial part of the affected individuals develop a~     number of psychological symptoms. The characteristic symptom pattern occurring in the~     aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes~     functional impairment of the affected individuals. The investigators want to test whether~     Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in~     formerly abducted children and youths and former child soldiers, when applied by lay~     personnel.~   "
229558|NCT00551993|"~     The purpose of this study is to conduct a trial of robotic assisted versus traditional~     laparoscopic sacrocolpopexy in the treatment of patients with vaginal prolapse.~   "
229559|NCT00551980|"~     This study is a controlled, cluster randomised, interventional trial to evaluate the~     effectiveness of a workplace cognitive and physical program (Intervention), in reducing the~     frequency of head and neck pain in an extensive working population.~   "
229560|NCT00551967|"~     The specific aim of this proposed study is to conduct a prospective RSA clinical study at~     Massachusetts General Hospital involving 50 patients receiving primary total hip~     replacements. All patients will receive the vitamin E treated polyethylene acetabular~     inserts. Short-term femoral head penetration and long-term steady state wear of the~     polyethylene will be measured using both RSA and Martell analysis techniques. Stability of~     the acetabular and femoral components will be measured in all patients using RSA analysis.~     The stability of the cemented femoral stems will be compared to the stability of the~     cementless femoral components as well as to historic data in the literature. In addition, all~     patients will complete a self-administered questionnaire to assess the clinical outcome of~     the surgery and patient satisfaction.~   "
229561|NCT00551954|"~     Endothelial dysfunction (ED) has been suggested as a possible causal link between~     postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent~     trials demonstrated a reduction of cardiovascular events by treatment with the alpha~     glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions.~     We were interested whether patients with newly diagnosed type 2 diabetes showed postprandial~     ED and if so whether acarbose was able to improve this condition.~   "
229562|NCT00551941|"~     The researchers propose a prospective, randomised partially-blinded study to investigate the~     clinical and radiological outcome, effect on quality of life and socio-economic impact of~     non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen~     allograft, in comparison to treatment with allograft together with DBM (demineralised bone~     matrix).~   "
229564|NCT00551915|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3~     formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant~     hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and~     inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 3~     formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be~     acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all~     antigens.~   "
229565|NCT00551902|"~     In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye~     and allows for the lowering of the pressure inside the eye. The flow through the surgically~     created fistula determines the intraocular pressure. Titrating suture tightness is important~     to achieving the desired post-operative intraocular pressure. This process is not~     straightforward and intraocular pressures are often too high or too low post-operatively.~   "
229566|NCT00551889|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Celecoxib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving cyclophosphamide together with celecoxib may help kill more~     cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when~     given together with cyclophosphamide in treating patients with advanced cancer.~   "
229567|NCT00551876|"~     The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing~     20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the~     dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).~   "
229568|NCT00551863|"~     The purpose of this project is to develop and pilot test a violence prevention intervention~     for men and women in treatment for substance use problems.~   "
229569|NCT00551850|"~     The Epidermal Growth Factor Receptor (EGFR) is a validated target for the treatment of~     cancer, and agents targeting EGFR such as erlotinib (Tarceva®) are approved by the FDA for~     treatment of various solid tumors. AV-412 is a novel inhibitor of the EGFR-tyrosine kinase,~     with added activity against Her2 and other oncogenic kinases. Based on evidence of~     preclinical activity in various solid tumors, AV-412 is being developed as a possible novel~     treatment for cancer in humans.~      PURPOSE: The purpose of this study is to test the safety and tolerability of AV-412, and~     determine the maximum tolerated dose of AV-412 when administered orally three times weekly.~   "
229570|NCT00551837|"~     The purpose of this study is to evaluate the immune response to a routine influenza~     vaccination. Influenza vaccination is given as part of routine standard of care in these~     individuals and is not part of the study protocol. The study will evaluate for a change in~     response to common antigens over time after influenza vaccination to determine if changes are~     related to the development of chronic rejection after solid-organ transplantation. We~     hypothesize that the influenza vaccine contributes to the alloreactivity of T cells verses~     common HLA types in the donor pool.~   "
229571|NCT00551824|"~     This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal~     strictures.~      This is a crossover, controlled, clinical trial in which children with esophageal stricture~     will be randomized in two groups to receive either topical mitomycin or no additional~     treatment during standard esophageal dilation session.~   "
229572|NCT00551811|"~     A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects~     who have been challenged with ozone.~   "
229573|NCT00551798|"~     Predicting response to chemotherapy in patients with Hodgkin's disease or lymphoma high-grade~     malignant de novo or recurrence.~      The non-Hodgkin's lymphoma and high-grade Hodgkin's disease may show resistance to~     chemotherapy, regardless of their initial extension. The failure of treatment is most often~     correlated with an incomplete answer or lack of response to chemotherapy as a result~     chemoresistance. This drug, which may involve the gene MDR1 (multidrug resistance) encoding~     the protein PGP, can be studied in vivo by MIBI scan. The MIBI is behind a tracer~     perfusionnel used routinely to explore myocardial perfusion, but it has other characteristics~     of fixing, which can be used in oncological imaging (fixation by glial tumors of high~     grade).Prospective Study, which includes conducting a tomoscintigraphie 30 minutes after~     injection of 20 mCi of 99mTc-MIBI in initial stock or relapse of high-grade lymphoma and~     Hodgkin's disease any stage (I-IV). Fixing the MIBI is compared with morphological~     abnormalities detected by CT and the setting of lesions by 18FDG. Patients will be treated in~     a traditional way, without changes in treatment protocols used in routine. Patients with a~     negative MIBI scan, will be watched with particular attention in order to detect insufficient~     response to chemotherapy. The only change, the care of patients, only for the achievement of~     an initial consideration of non-invasive imaging, further, which is the tomoscintigraphie the~     MIBI. Of the tumor samples, will be evaluated by immunohistochemistry, the expression of PGP~     and the MRP1 (two proteins associated with the drug). On blood, may be carried out genotyping~     of MDR1, MRP1 and MRP2 to the patient.~   "
229574|NCT00551785|"~     The primary objective of the study is to assess the risks of testosterone transdermal patch~     use in a representative study population. The primary clinical outcome of interest is breast~     cancer.~   "
229575|NCT00551772|"~     SB-742457 is a 5HT6 receptor antagonist that is in development for the symptomatic treatment~     of mild to moderate Alzheimer's disease . To date, all clinical trials have been conducted~     using a capsule formulation of SB-742457. However, it is intended to conduct all futures~     studies with a tablet formulation. The aim of this study is to assess the pharmacokinetic~     profile of SB-742457 and its major metabolites following single doses of both the capsule and~     tablet formulations.~   "
229601|NCT00551434|"~     The study is a double blind 2x2 factorial study. Patients with coronary disease will be~     randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary~     supplement. The function of the endothelium will be tested using ultrasound before and after~     each treatment. These studies will help us understand why the endothelium is abnormal in~     patients with coronary artery disease and how L-arginine is acting on endothelial function.~   "
229823|NCT00548483|"~     The specific objectives were to determine whether high dose dexamethasone are more effective~     than low dose dexamethasone in the reduction or prevention of post-extubation airway~     obstruction among patients with a cuff leak volume (CLV) < 110 mL.~   "
229576|NCT00551759|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and docetaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving these treatments before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~     Giving docetaxel and cetuximab after surgery may kill any tumor cells that remain after~     surgery.~      PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy~     together with cetuximab followed by surgery, docetaxel and cetuximab works in treating~     patients with esophageal cancer or gastroesophageal junction cancer.~   "
229577|NCT00551746|"~     Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the~     Western world and is associated with high-calorie diet, high body mass, and a variety of~     other factors. CHD can lead to myocardial infarction (MI) and other embolic events. In some~     areas such as France, though, a paradox of high-cholesterol diets but low CHD and MI~     incidence have been found. This paradox has been traced to the consumption of red wine.~     Further research suggests that components of the grapes used in red wine may be the source of~     the cardio-protective factors that have resulted in the French paradox. These components are~     also present in purple grape juice (PGJ). PGJ has been shown to have a variety of potential~     cardio-protective effects, including inhibition of platelet aggregation. Since PGJ does not~     contain alcohol it may provide an additional benefit by avoiding the physical and social~     implications of alcohol abuse. Since most of the research of PGJ has been in vitro, though,~     and the few studies in vivo have been in cross-over studies and over very short durations of~     7 to 14 days, additional research is required to determine whether the long-term consumption~     of PGJ is of additional and sustained benefit, similar to long-term use of red wine in~     France. The proposed study is a 2 arm randomized, controlled (double-blind) study of PGJ and~     a calorically-matching placebo drink in 100 healthy individuals.~   "
229578|NCT00551733|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and paclitaxel~     poliglumex, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known whether giving carboplatin~     together with paclitaxel poliglumex is more effective than giving carboplatin together with~     paclitaxel in treating non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel poliglumex to~     see how well they work compared with carboplatin and paclitaxel in treating women with stage~     III, stage IV, or recurrent non-small cell lung cancer.~   "
229579|NCT00551720|"~     The purpose of this study is to develop and evaluate a brief, clinic-based smoking cessation~     treatment for an HIV+ population. We compared two treatments, a brief advice and follow-up~     plus nicotine patch treatment(Standard Care; SC) and brief advice and follow-up, nicotine~     patch, with the addition of a tailored motivational intervention and behavioral skills~     counseling for smoking cessation (Motivationally-Enhanced; ME), in a randomized controlled~     trial. We hypothesized that those HIV+ participants receiving the ME will demonstrate greater~     biochemically verified smoking abstinence rates at 6-month follow-up than those receiving the~     SC control treatment. All study participants were offered use of the nicotine patch.~   "
229580|NCT00551707|"~     CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug~     dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to~     work through a novel mechanism of action in which dipyridamole selectively amplifies the~     anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating~     the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in~     proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis~     (RA).~      In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to~     existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including~     methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in~     combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted~     to reflect the current standard of care practices within rheumatology.~   "
229581|NCT00551694|"~     The purpose of this study is to compare the effects of single and repeat doses of GSK256073~     with placebo in HVT subjects that have been administrated GSK256073 in the HMA107787 study~   "
229582|NCT00551681|"~     To compare a surgical approach of LV lead placement for BIV pacing with the conventional~     transvenous approach by assessment of differences on the effects on cardiac perfusion and~     relate this to the clinical cardiac function.~   "
229583|NCT00551668|"~     The objective of this prospective, randomized cohort study was to evaluate the clinical~     results between operative and nonoperative treatment of primary patellar dislocation.~   "
229584|NCT00551655|"~     Tenofovir (TDF)-containing regimens may be associated with decreasing renal function in~     HIV-infected patients concurrently treated with boosted PI's and/or have co-morbid conditions~     including diabetes mellitus, hypertension, anemia, hepatitis B, and hepatitis C.~   "
229585|NCT00551642|"~     The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to~     reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to~     assess the long-term effects of the therapy on the development of these children over 7 years~     of clinical follow-up.~   "
229586|NCT00551629|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4~     different formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate,~     recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular~     pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at~     least 1 of the 4 formulations of HR5I administered as a primary series at 2, 3, and 4 months~     of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody~     responses to all antigens.~   "
229587|NCT00551616|"~     The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to~     levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.~   "
229839|NCT00548275|"~     The major goal is to determine in patients entering buprenorphine treatment, the prevalence~     of specific sex-related HIV risk behaviors, their physician's screening of these behaviors~     and to evaluate the impact of risk reduction counseling.~   "
229588|NCT00551603|"~     Several recent reports support the efficacy of once every-other-week epoetinum administration~     in the maintenance phase of the anaemia treatment in predialysis, haemodialysis and in~     peritoneal dialysis CKD patients.~      However, there are studies suggesting that in HD patients receiving SC short-acting ESA~     therapy, ESA efficacy decreases when the dosing is extended from thrice-weekly to once-weekly~     administration. When every-2-week administration of long-acting ESAs is extended to every 4~     weeks, efficacy either remains stable or decreases incrementally. The GAIN trial (Gain~     effectiveness in Anemia treatment with NeoRecormon®) was designed to compare anemia~     management with epoetin beta, epoetin alpha or darbepoetin alpha in HD patients. An interim~     analysis of data from 1005 stable HD patients suggested that switching to epoetin beta from~     either epoetin alpha or darbepoetin alpha resulted in improved efficacy and a 20% dose~     reduction in SC epoetin beta.~      The aim of the study is to compare two schedules of anaemia treatment in HD patients using~     two different erythropoietic stimulating agents (epoetinum beta vs darbepoetinum) with~     respect to the efficacy in anaemia correction and to the haemoglobin (Hb) level stability.~      This is a multicenter (2 centers), prospective, open-label, parallel, controlled trial of~     therapy equivalence~   "
229589|NCT00551590|"~     The purpose of this study is to assess the effect of the DPP-4 inhibitor sitagliptin on the~     incretin effect in patients with type 2 diabetes mellitus.~   "
229590|NCT00551577|"~     The purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and~     observation of anatomical and biological indicators (i.e. ascites or continuous measurement~     of tumor marker CA 125). Furthermore the optimal number of preoperative administered cycles~     of combination chemotherapy with carboplatin and docetaxel should be determined.~   "
229591|NCT00551564|"~     Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual~     to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis.~     Non-diabetics with IR are at risk, but can be difficult to diagnose.~      A major problem with the use of IR as a predictor or marker of disease is the lack of a~     simple, robust test that can be used to quantify this parameter in a wide variety of clinical~     situations. The current 'gold standard' methods for measuring insulin sensitivity, such as~     the hyperinsulinemic-euglycemic (H-E) clamp, are complex, time consuming and costly.~     Alternative, simpler methods, such as the Homeostasis Model Assessment (HOMA-IR) score, may~     be less accurate and are not widely accepted.~   "
229592|NCT00551551|"~     Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital~     prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of~     women with prenatal pelvic floor exercises and a control group.~      Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.~   "
229593|NCT00551538|"~     The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will~     result in lower post prandial blood glucose readings versus once-daily glargine plus oral~     diabetic medications.~   "
229594|NCT00551525|"~     RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal~     radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from~     growing in patients with rising prostate-specific antigen (PSA) levels after radical~     prostatectomy for prostate cancer.~      PURPOSE: This phase II trial is studying how well samarium Sm 153 lexidronam pentasodium and~     3-D conformal radiation therapy or intensity-modulated radiation therapy work in treating~     patients with rising PSA levels after radical prostatectomy for prostate cancer.~   "
229595|NCT00551512|"~     The purpose of this research study is to find the answers to the following questions:~        1. What are the highest doses of CBP501 and cisplatin that can be safely administered as~          consecutive 2-hours and 1-hour infusions every 21 days?~        2. What are the side effects of the combination of CBP501 and cisplatin when given as an~          infusion every 21 days?~        3. What amount of CBP501 and cisplatin are found in the blood at certain times after it is~          given?~        4. Are there any substances in your blood or tumor that can tell us about tumor sensitivity~          to CBP501 and cisplatin?~        5. Will CBP501 given with cisplatin help to treat your cancer?~   "
229596|NCT00551499|"~     The primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients~     with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of~     overdrive pacing. Secondary objectives are to evaluate the effects of a single night of~     overdrive pacing applied after 12 weeks of CRT vs. CRT alone on breathing events, sleeping~     events, and neurohormonal markers. An additional secondary objective of the study is to~     compare the efficacy of CRT in HF patients with concomitant CSA to HF patients without~     concomitant CSA.~   "
229597|NCT00551486|"~     To investigate the diagnostic efficiency of pyrosequencing for the mutant BRAF allele in~     ultrasound (US)-guided fine needle aspiration biopsies (FNAB) of thyroid incidentalomas.~   "
229598|NCT00551473|"~     Current treatment for gastroesophageal reflux disease(GERD)confirms an unmet need in~     patients, based on slow onset of action and an inability to provide 24-hour gastric acid~     suppression. Clinical data on lavoltidine demonstrates a rapid onset of action, high potency,~     and prolonged duration of effect after single dose. Since tolerance to the class of compounds~     to which lavoltidine belongs may be dose dependent, the current study is designed to~     determine if 40mg lavoltdine given for 7days develops tolerance.~   "
229599|NCT00551460|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and~     help kill them or carry cancer-killing substances to them. Others interfere with the ability~     of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic~     leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination~     chemotherapy may be more effective in treating promyelocytic leukemia.~      PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination~     chemotherapy works in treating patients with previously untreated promyelocytic leukemia.~   "
229600|NCT00551447|"~     This purpose of this study is to determine if the administration of ezetimibe and simvastatin~     together is more effective than simvastatin alone in lowering LDL-C levels to a goal of <100~     mg/dL in patients at risk for Heart Disease.~   "
229840|NCT00548262|"~     The primary objective is to estimate global response rate. Clinical, microbiological and~     global response rates and its 95% confidence intervals will be computed. No hypotheses will~     be tested.~   "
229602|NCT00551421|"~     Monoclonal antibodies, such as pertuzumab and cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Giving pertuzumab together with~     cetuximab may kill more tumor cells. This phase I/II trial is studying the side effects and~     best dose of pertuzumab when given together with cetuximab and to see how well they work in~     treating patients with previously treated locally advanced or metastatic colorectal cancer~   "
229603|NCT00551408|"~     Endothelial dysfunction ultimately represents an imbalance between the magnitude of injury~     and the capacity for repair.~      Current evidence established that endothelial progenitor cells (EPC) participate in several~     models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery~     disease, etc. However EPC in the setting of PAH is less well established. The target of this~     study is to demonstrate if the number of EPC is increased in a mexican population of patients~     with PAH.~   "
229604|NCT00551395|"~     This study will evaluate the effect of the timing of treatment completion in two-staged~     selective laser trabeculoplasty therapy on intraocular pressure lowering effect.~   "
229605|NCT00551382|"~     Viral upper respiratory tract infection (URI) is one of the most common diseases among~     toddlers and pre-school children.Complete and effective prevention measures for URI are~     currently unavailable.~      Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the~     cysteinyl leukotriene 1 receptor. It is well tolerated and safe even in young children.~     Montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age.~     Infections with viruses causing URI such as Influenza A, Rhinovirus and respiratory syncitial~     virus increases leukotriens levels in nasal secretions. Therefore, one may postulate that~     leukotriens inhibitors may reduce symptoms during URI. However the effect of montelukast as a~     treatment for non-specific cough was not properly studied and there are no studies on the~     effect of montelukast as prevention for URI.~      Hypothesis: Prophylactic treatment with Montelukast will reduce the incidence and severity of~     upper respiratory infection in children.~   "
229606|NCT00551369|"~     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue near the tumor.~      PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works~     in treating patients with stage I or stage II non-small cell lung cancer that can be removed~     by surgery.~   "
229607|NCT00551356|"~     In patients with type 2 diabetes who have not been on insulin therapy before the study will~     achieve better glycemic control by the treatment regiment consisting of two times daily~     insulin lispro mix 25 than by the treatment regiment with consisting of one time daily~     injection of insulin glargine. Improved glycemic control will be compared by the fasting~     plasma glucose and blood glucose excursions 2 hours after breakfast.~   "
229608|NCT00551343|"~     The purpose of this study is to investigate the effects of a GLP-1 agonist on satiety~     hormones in patients with Prader-Willi Syndrome (genetic defect causing obesity).~   "
229609|NCT00551330|"~     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government~     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5~     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells~     that fight infection). Previous smaller studies in HIV treatment-experienced patients, have~     shown that vicriviroc is safe and effective. The purpose of this study is to investigate in~     subjects with detectable dual/mixed CCR5/CXCR4-tropic HIV whether vicriviroc when added to~     other appropriate HIV drugs can decrease the level of HIV (viral load) in the blood and that~     it is well tolerated.~      This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study of~     vicriviroc maleate in HIV subjects infected with dual/mixed CCR5/CXCR4-tropic virus and who~     have documented resistance to at least 2 of the 3 antiretroviral drug classes (NRTI, NNRTI or~     PI) or at least 6 months experience with at least 2 of the following: one NRTI, one NNRTI, or~     one PI (excluding low-dose ritonavir) and failure on their current stable regimen. The study~     will compare the virologic benefit of adding vicriviroc to an optimized background regimen to~     a control group receiving placebo plus the new optimized background therapy. The optimized~     background regimen will be chosen by the investigator based on results of drug susceptibility~     tests performed at Screening, history of prior antiretroviral drug use by the patient, and~     drug toxicity. Primary efficacy analysis will be conducted when all subjects have completed~     48 weeks of treatment. An interim analysis will be performed when all subjects have completed~     24 weeks of treatment. Subjects who complete 48 weeks of treatment, or who discontinue early~     but are deemed eligible upon rescreening, will be offered participation in the open-label~     segment of the study, and will receive vicriviroc 30 mg once daily, if appropriate, until~     commercially available or until the sponsor terminates the clinical development of~     vicriviroc.~   "
229610|NCT00551317|"~     This study is being conducted to provide initial safety, tolerability, PK and PD data that~     will allow further studies with darapladib in Japanese patients~   "
229611|NCT00551304|"~     To investigate the utility of renal denervation in the treatment of patients with End Stage~     Renal Disease (ESRD).~   "
229612|NCT00551291|"~     This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon,~     CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes~     (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily)~     plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon~     (30000 IU/week, s.c.) will be added to the treatment regimen. If there is no response to~     NeoRecormon after 6 weeks, the dose will be increased to 60000 IU/week. The anticipated time~     on study treatment is 3-12 months, and the target sample size is <100 individuals.~   "
229613|NCT00551278|"~     The purpose of this trial is to show adequate assay performance on clinical samples tested in~     real time at the clinical site.~   "
229614|NCT00551265|"~     This randomized clinical trial is studying the side effects of oregovomab and to see how well~     it works with or without cyclophosphamide in treating patients with stage III or stage IV~     ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that responded~     to second-line chemotherapy. Monoclonal antibodies, such as oregovomab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. It is not yet known~     whether oregovomab is more effective when given together with or without cyclophosphamide in~     treating patients with stage III or stage IV ovarian epithelial cancer, fallopian tube~     cancer, or primary peritoneal cancer.~   "
229615|NCT00551252|"~     The purpose of this study is to evaluate the antitumor activity of a combination of Imatinib~     mesylate and Gemcitabine in patients with unresectable malignant mesothelioma expressing~     either PDGFR-beta or C-kit~   "
229616|NCT00551239|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and pixantrone, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. It is not yet known whether giving~     fludarabine together with rituximab is more effective with or without pixantrone in treating~     indolent non-Hodgkin lymphoma.~      PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how~     well they work with or without pixantrone in treating patients with relapsed or refractory~     indolent non-Hodgkin lymphoma.~   "
229617|NCT00551226|"~     We have previoulsy shown that patients with active Tuberculosis develop a wide array of~     autoantibodies including rheumatoid factor, anti-CCP, Antinuclear facyor and anti Sm~     antibodies. The purpose of this study is to evaluate whether the level of autoantibodies~     decrease after treatment aganist tuberculosis.~   "
229618|NCT00551213|"~     The purpose of this study was to determine the activity of two doses of robatumumab (SCH~     717454, MK-7454) in participants with relapsed or recurrent colorectal cancer.~      The primary study hypothesis was that decreases in Positron Emission Tomography~     (PET)-assessed tumor glucose metabolism (i.e., fluorodeoxyglucose [FDG] standardized uptake~     value [SUV]) following administration of 10 mg/kg robatumumab will exceed those following~     administration of 0.3 mg/kg robatumumab in participants with relapsed or recurrent colorectal~     cancer who had progressed after first-line chemotherapy.~      Investigator choices of standard chemotherapy: irinotecan as a single agent +/- cetuximab OR~     capecitabine as a single agent, OR FOLFOX (leucovorin calcium [folinic acid][FOL] +~     fluorouracil [F] + oxaliplatin [OX]) OR CAPEO(capecitabine [CAPE] or Xeloda® [XEL] +~     oxaliplatin [OX]) OR FOLFIRI (leucovorin calcium [folinic acid][FOL] + fluorouracil [F] +~     irinotecan [IRI]) +/- cetuximab OR cetuximab as a single agent.~   "
229619|NCT00551200|"~     The purpose of this study is to determine whether HPN-100 is safe and tolerable in subjects~     with Urea Cycle Disorders.~   "
229620|NCT00551187|"~     The purpose of this study is to evaluate vaccine immunogenicity and how well the body~     tolerates V504 when given with Gardasil.~   "
229621|NCT00551174|"~     This 2-arm study was designed to assess the long-term safety and tolerability of intravenous~     (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had~     previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received~     Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received~     daily supplementation with vitamin D and calcium. The anticipated time on study treatment was~     2+ years, and the target sample size was 500+ individuals.~   "
229622|NCT00551161|"~     We are studying subjects with mild to moderate Alzheimer's disease who have been on a stable~     dose of any cholinesterase inhibitor [donepezil (Aricept), rivastigmine (Exelon), or~     galantamine (Razadyne)] for at least 3 months, and have not previously taken memantine~     (Namenda). This is an open-label study, with magnetic resonance spectroscopy (MRS) as the~     primary outcome measure, along with neuropsychological testing, and optional lumbar puncture,~     evaluating patients on their stable dose of a cholinesterase inhibitor over 24 weeks,~     followed by another 24 weeks on memantine in combination with stable dose of cholinesterase~     inhibitor. The purpose of this study is to characterize the progression of disease using MRS,~     cerebrospinal fluid (CSF) biomarkers, and cognitive outcome measures, and to determine~     whether changes in cognitive function on neuropsychological testing are correlated to changes~     in MR spectroscopic and/or CSF biomarkers.~   "
229623|NCT00551148|"~     The purpose of this study is to further explore an effective dose range of PD0200390 for the~     treatment of patients with insomnia.~   "
229624|NCT00551135|"~     The purpose of this study is to test whether pregabalin added to the standard of care with~     dosing starting preoperatively and continuing for 1 week post surgery will decrease the~     intensity of acute post-operative pain following inguinal hernia repair.~   "
229625|NCT00551122|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, ifosfamide, and~     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when~     given together with paclitaxel, ifosfamide, and cisplatin, and to see how well they work in~     treating patients with progressive or relapsed metastatic germ cell tumors.~   "
229626|NCT00551109|"~     The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the~     treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety~     of SA4503 compared to placebo in subjects with MDD.~   "
229627|NCT00551096|"~     Zactima will be used in this study to determine the highest dose that can be given safely as~     well as the side effects of Zactima when in combination with two FDA approved drugs;~     gemcitabine and capecitabine. This combination will be given to patients with advanced solid~     tumors. Once the highest dose of the combination has been determined, additional patients~     with biliary cancers (cholangiocarcinomas and gallbladder cancer) and locally advanced or~     metastatic pancreatic cancer will be treated at the highest determined dose for further~     studies.~   "
229628|NCT00551083|"~     The purpose of this study was designed to test the feasibility and effectiveness of~     implementing a Computerized Decision Support System for depression (CDSS-D) during acute care~     in a primary care setting.~   "
229629|NCT00551070|"~     This phase II trial studies the side effects and how well selumetinib sulfate works in~     treating patients with low-grade ovarian cancer that has come back. Selumetinib sulfate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
229630|NCT00551057|"~     The purpose of this trial is to investigate the expression of different inflammatory proteins~     in cancer and normal pancreatic tissue.~   "
229631|NCT00551044|"~     The aim of this study is to comprehensively monitor the effects of a nonsteroidal~     antiandrogen in patients requiring hormone manipulation for prostate cancer~   "
229676|NCT00550446|"~     The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5~     doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of~     seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®)~     and one out of seven will only receive inactive substances (placebo.)~   "
229632|NCT00551031|"~     The present formulations are being developed for further study in the elderly population in~     order to generate additional supporting data.~      Primary Objective:~      To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received~     either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV)~     compared to that of the standard Fluzone® in elderly subjects.~      Secondary Objectives:~      Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone~     and standard Fluzone®.~      Safety:~      To evaluate and describe the safety profile of investigational Fluzone in terms of solicited-~     and unsolicited adverse events and serious adverse events post-vaccination.~   "
229633|NCT00551018|"~     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government~     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5~     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells~     that fight infection). Previous smaller studies in HIV treatment-experienced patients, have~     shown that vicriviroc is safe and effective. The purpose of this study is to evaluate the~     virologic efficacy of vicriviroc combined with ritonavir-boosted Reyataz® in HIV-infected~     treatment-naïve subjects.~   "
229634|NCT00551005|"~     RATIONALE: Etoposide and celecoxib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Giving more than 1 drug may be an effective treatment for~     advanced cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when~     given together with etoposide in treating patients with advanced cancer.~   "
229635|NCT00550992|"~     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of~     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. When the healthy stem cells from a donor are infused into the patient they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin~     before and after transplant may stop this from happening. It is not yet known which treatment~     regimen is most effective in treating acute leukemia.~      PURPOSE: This randomized clinical trial is studying how well different therapies work in~     treating infants with newly diagnosed acute leukemia.~   "
229636|NCT00550979|"~     The purpose of this research study is to look at whether there are differences in blood~     vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels,~     and levels of other blood markers in women who have had a pregnancy complicated by diabetes~     as compared with women who have had a normal pregnancy.~   "
229637|NCT00550966|"~     This research project pretends to demonstrate that a psychoeducative program implemented in~     the context of PC can produce a significant increase in the quality of life of patients with~     FM, as well as a decrease in the use of sanitary and social services, compared to usual care.~   "
229638|NCT00550953|"~     The primary purpose of this study is to:~      Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is~     superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately~     controlled with telmisartan 40 mg monotherapy.~   "
229639|NCT00550940|"~     This study aims to Investigate characteristics and prevalence of emotion/behavior problems in~     child and adolescents with epilepsy; to identify the associated factors and their effects on~     these children/adolescents; and to examine their attention by using Conners' Continuous~     Performance Test (CPT).~   "
229640|NCT00550927|"~     RATIONALE: Enzastaurin may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Enzastaurin and~     bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer.~     Giving enzastaurin together with bevacizumab may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin and~     bevacizumab in treating patients with locally advanced or metastatic cancer.~   "
229641|NCT00550914|"~     The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the~     time interval between surgeries and improve voice outcomes in children with severe RRP.~   "
229642|NCT00550901|"~     RATIONALE: Drugs used in chemotherapy, such as dexrazoxane and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may help kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of dexrazoxane when~     given together with cisplatin in treating patients with advanced solid tumors.~   "
229643|NCT00550888|"~     There is no difference between extra-abdominal or in situ suture of the uterus in cesarean~     section.~   "
229644|NCT00550875|"~     As the principal objective of this study is to evaluate the efficacy and safety of the~     treatment measuring the changes in a symptom score, the patient will be asked to fill in a~     patient diary. This diary will evaluate the week before the patient comes back to receive the~     treatment. Nose (sneeze, blockage and running), eye (itching, redness and swelling) and chest~     (breathlessness, wheeze, chest tightness), are scored on a scale from The patient will be~     instructed to daily assess each one of the symptoms, recording them on an individual symptoms~     follow-up diary.~   "
229645|NCT00550862|"~     The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels~     in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to~     placebo.~   "
229646|NCT00550849|"~     This study assesses the safety and tolerability of RTA 402 in patients with liver disease.~   "
229677|NCT00550433|"~     The purpose of this clinical trial is to study the blood levels of a drug (conjugated~     estrogens) in the body from one dosage form compared to another. The four formulations of the~     study drug that eligible participants will receive will contain the same amounts of the same~     medications. In addition, information will also be obtained regarding the safety and~     tolerability of the formulations given to healthy postmenopausal women.~   "
229841|NCT00548249|"~     The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble~     Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during~     chronic hemodialysis.~   "
229647|NCT00550836|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of~     pancreatic cancer by blocking blood flow to the tumor.~      PURPOSE: This randomized phase II trial is studying how well giving panitumumab together with~     gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in~     treating patients with metastatic pancreatic cancer.~   "
229648|NCT00550823|"~     The diagnosis of infective endocarditis is based on the results of blood culture and findings~     on transeosophageal echocardiography. Cardiac computarized tomography is a new modality,~     mainly used for the imaging of coronary arteries. Its use in the diagnosis of infective~     endocarditis is not well known.The purpose of this study is to establish the use of cardiac~     CT in infective endocarditis.~   "
229649|NCT00550810|"~     The major goal is to determine whether the experimental agent has clinically promising~     activity that would merit progression to a formal phase III trial.~      Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited~     treatment options and no systemic treatment has been proven to be effective. Because of its~     action, safety and simple administration SU011248 has potential for effectiveness in this~     disease setting. Promising activity in this study would provide the necessary~     proof-of-principle for a larger confirmatory study in this population, and potentially in~     earlier stages of this common disease.~   "
229650|NCT00550797|"~     The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and~     examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness~     and airway inflammation.~   "
229651|NCT00550784|"~     RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of~     tumor cells by stopping them from dividing or killing them. Giving colony-stimulating~     factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone~     marrow to the blood so they can be collected and stored. More chemotherapy is then given to~     prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the~     patient to replace the blood-forming cells that were destroyed by the chemotherapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when~     given together with cyclophosphamide, paclitaxel, melphalan, and cisplatin, followed by an~     autologous peripheral stem cell transplant in treating patients with stage III, stage IV, or~     recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.~   "
229652|NCT00550771|"~     The purpose of this study is to compare the incidence of cardiac dysfunction in subjects with~     human epidermal growth factor receptor 2 (HER2) positive breast cancer treated with either~     doxorubicin or pegylated liposomal doxorubicin (PLD), both in combination with trastuzumab.~   "
229653|NCT00550758|"~     Rational: The possible contribution of methacholine challenge test via spirometry to the~     clinical diagnosis of young children with various respiratory symptoms, the most appropriate~     spirometry index, and the proper cutoff point concentration that will define airway~     sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry~     in a large group of children aged 3-6years with various respiratory symptoms.~   "
229654|NCT00550745|"~     The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years~     of age or older as required by the FDA.~   "
229655|NCT00550732|"~     The purpose of this study is to evaluate the efficacy and safety of posaconazole in the early~     treatment of fungal infections in participants who are refractory to, intolerant to, or~     medically precluded from first-line monotherapy or first-line combination antifungal therapy.~   "
229656|NCT00550706|"~     One year prospective analysis of drug utilization and prescription point prevalence of~     medications in a pediatric tertiary care university medical center. Off-label use of~     medications in the study population will be also registered.~   "
229657|NCT00550693|"~     There are currently no published data on the efficacy of the chlorhexidine-impregnated foam~     dressing to reduce catheter-related bloodstream infections (BSI) in hemodialysis patients.~      The researchers perfomed a cross-over intervention trial on patients who were dialyzed~     through central venous catheters at two outpatient dialysis centers were enrolled. The use of~     a chlorhexidine-impregnated foam dressing was incorporated into the catheter care protocol~     during the intervention period. A nested cohort study of all patients who received the foam~     dressing was also conducted to determine independent risk factors for development of BSI.~      The primary outcomes were the catheter-related bloodstream infection rates in the~     intervention and control groups. Secondary outcomes include the clinical sepsis rates between~     the two groups and risk factors for development of bloodstream infection despite the use of~     the foam dressing.~   "
229658|NCT00550680|"~     This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when~     administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal~     anemia. Individuals currently receiving maintenance treatment with epoetin alfa or~     darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120,~     200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or~     darbepoetin alfa they were receiving in the week preceding study start.~   "
229659|NCT00550667|"~     This study aims to establish the psychometric properties of the Adult ADHD Quality of Life~     Scale (AAQoL) and to validate the diagnosis of adult ADHD by ADHD symptoms, other clinical~     psychiatric symptoms, neuropsychological functioning, social/family/occupational functioning,~     and intervention effect.~   "
229660|NCT00550654|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase II trial is studying how well conformal radiation therapy works in~     treating patients with metastatic cancer outside the brain.~   "
229774|NCT00549146|"~     Relatively little information is available about the effects of salmeterol/fluticasone~     combination and fluticasone alone in COPD patients with a partial reversible pulmonary~     obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone~     combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with~     COPD on lung function over a 1 year period.~   "
229661|NCT00550641|"~     Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management,~     but different non-pharmacologic measures, especially physical therapies and~     psychologically-based interventions, have also shown to be effective in the treatment of this~     disease. The objective of the present randomized controlled trial is to compare the efficacy~     and tolerability of two different modalities of active low-impact exercise in warm water:~     stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting~     60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12~     weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and~     the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck~     Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12~     Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired~     Student's t test, and effect sizes' estimation (ES).~   "
229662|NCT00550628|"~     RATIONALE: Diagnostic imaging procedures, such as fludeoxyglucose F 18 PET, may be effective~     in detecting cancer or recurrence of cancer, or premalignant polyps.~      PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it~     works in determining protein and gene expression signatures in patients with premalignant~     polyps or colon cancer.~   "
229663|NCT00550615|"~     Primary Objective:~        -  To determine the maximum tolerated dose (MTD) of Dasatinib in relapsed or refractory~          non-hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL.~      Secondary Objectives:~        -  To assess the complete and overall response rates for all Phase I and Phase II patients~          and to determine overall survival and event free survival for all Phase I and Phase II~          patients.~        -  To assay the levels of kinase activity in NHL specimens and correlate this activity to~          patient outcomes.~   "
229664|NCT00550602|"~     The purpose of this study is to evaluate respiratory symptoms and their impact in the quality~     of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).~   "
229665|NCT00550589|"~     RATIONALE: High-grade squamous intraepithelial lesions of the skin near the anus are caused~     by the human papillomavirus (HPV). Antiviral drugs,, such as cidofovir, act against viruses~     and may stop these lesions from becoming cancer.~      PURPOSE: This phase II trial is studying the side effects and how well topical cidofovir~     works in treating HIV-infected patients with high-grade squamous intraepithelial lesions of~     the skin near the anus.~   "
229666|NCT00550576|"~     Subjects suffering from bipolar disorders treated with specific medications will give their~     informed concent and will receive intravenously only one dose of Digoxin antibodies (Fab).~     Their response to this therapy will be measured accordingly.Previous medications will be not~     changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured~     using a specific laboratory technique and these compounds will be measured at 6 and 24 hours~     after Fab therapy.~      Patients also will be followed using clinical and psychological tests~   "
229667|NCT00550563|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This clinical trial is studying changes in DNA that affect vitamin D metabolism in~     patients with colorectal cancer receiving vitamin D supplements.~   "
229668|NCT00550550|"~     The purpose of the study is to investigate the efficacy and safety of a grass sublingual~     tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis~     with or without asthma.~   "
229669|NCT00550537|"~     RATIONALE: Studying samples of tumor tissue, blood, and urine in the laboratory from patients~     receiving erlotinib may help doctors predict how patients will respond to treatment.~      PURPOSE: The phase II trial is studying proteomic profiling to see how well it predicts~     response in patients receiving erlotinib for stage IIIB, stage IV, or recurrent non-small~     cell lung cancer.~   "
229670|NCT00550524|"~     The purpose of this study is to find if autologous stem cell transplantation can improve~     clinical manifestations of knee osteoarthritis.~   "
229671|NCT00550511|"~     The purpose of this study is to evaluate whether surgeon-performed ultrasound as a supplement~     to clinical investigation when a patient presents with abdominal pain in the emergency~     department can improve the management of the patient.~   "
229672|NCT00550498|"~     The purpose of this study is to find if autologous stem cell transplantation can stop the~     progression of intractable eye lesions of Behcet's Disease or even to improve it.~   "
229673|NCT00550485|"~     The ABCB1-gene product P-glycoprotein is an integral membrane protein that actively~     transports substrates out of the intracellular compartment. One of the major sites of its~     action is the blood-brain-barrier. It is highly expressed in brain capillary endothelial~     cells and involved in limiting the access of substrates such as antidepressants to the~     central nervous system. A single nucleotide polymorphism (SNP) of the ABCB1-gene was recently~     identified showing a different treatment response to antidepressant drugs depending on the~     genotype. Therefore, it is assumed that healthy subjects with different genotypes of that SNP~     will be associated with significantly different brain levels of the antidepressant~     escitalopram after 6 days of intake. Sleep recordings are a useful bio-marker for effects of~     antidepressants on the CNS. Selective serotonin reuptake inhibitors (e.g. escitalopram) cause~     a suppression of REM sleep and a stronger fragmentation of sleep compared to untreated~     subjects. Higher plasma levels of antidepressants affected the sleep to a greater extent than~     lower levels. In line with this finding, we suppose that sleep EEG recordings of healthy~     subjects with different genotypes of the above mentioned SNP will be differently affected~     after taking 6 days escitalopram. In addition, effects of drug intake on the gene expression~     in lymphocytes and metabolic changes will be assessed.~   "
229674|NCT00550472|"~     The study was performed to investigate the effects of a probiotic supplementation containing~     Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 and Bifidobacterium animalis~     subsp. lactis DGCC 420 (B. lactis 420) on clinical, immunological and faecal parameters in~     healthy volunteers and in patients with atopic dermatitis (AD).~   "
229675|NCT00550459|"~     Demonstrate an improvement in the composite scores of validated neurocognitive tests in~     elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.~   "
229855|NCT00548067|"~     The purpose of this study is to determine potential pharmacokinetic drug-drug interaction~     when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.~   "
229678|NCT00550420|"~     This is a Phase III, multicenter, open-label extension, single-group study in male and female~     outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All~     subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4~     weeks of the study followed by 8mg RSG XR. Subject participation will last until one of 5~     conditions applies. After a 52-week open-label treatment phase, subjects will attend a final~     Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to~     evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD~     who have completed AVA105640. The secondary objective of this study is to explore further the~     long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as~     a function of apolipoprotein E (APOE) e4 allele status~   "
229679|NCT00550407|"~     This study is planned to objectively assess the efficacy and safety of lamotrigine~     maintenance therapy after symptoms of mood episode had been stabilised by open-label~     treatment with lamotrigine alone or in combination with other psychotropic medication in~     patients with bipolar I disorder.~   "
229680|NCT00550394|"~     The purpose of this research study is to study the effects (both good and bad) of combining~     quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of~     elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor~     judgment, reckless behavior) and to study the effects (both good and bad) of combining~     quetiapine and topiramate for reducing use of alcohol.~   "
229681|NCT00550381|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     single doses of HKI-357 administered to healthy subjects.~   "
229682|NCT00550368|"~     The study proposes to test whether chronic infection with Helicobacter pylori protects~     individuals from symptomatic infection with enteropathogenic E. coli. The study will also~     evaluate the effect of gastric acidity in this relationship.~   "
229683|NCT00550355|"~     This study is designed to evaluate the safety and tolerability of multiple intravenously~     administered doses of PD 0360324 in patients with rheumatoid arthritis receiving~     methotrexate.~   "
229684|NCT00550342|"~     The purpose of this study is to determine whether the approved drug, rituximab, is effective~     in the treatment of focal segmental glomerulosclerosis (FSGS)~   "
229685|NCT00550329|"~     The objective of this study is to determine the bioequivalence of Glipizide GITS (Glucotrol~     XL) 2.5 mg tablets manufactured at the Brooklyn, New York facility versus tablets~     manufactured at the facility in Barceloneta, Puerto Rico.~   "
229686|NCT00550303|"~     The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen~     formulations for future testing purposes.~   "
229687|NCT00550290|"~     This randomized prospective study will specifically investigate the efficacy of a 24 hour~     post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in~     preventing wound infection and wound breakdown following vulvectomy.~   "
229688|NCT00550277|"~     Inhibition of histone deacetylase (HDAC) provides a novel approach for cancer treatment.~     LBH589, an oral HDAC inhibitor, has been well tolerated in phase I trials and has shown~     activity against several types of cancer. In this nonrandomized phase II trial, we are~     investigating the activity of LBH589 in the treatment of patients with refractory clear cell~     renal carcinoma.~   "
229689|NCT00550264|"~     Patients admitted to inpatient medicine services often require early hospital readmission,~     and often they are readmitted to different physician or team, potentially without the~     knowledge of the prior physician or team. Thus, physicians may lose the opportunity to share~     valuable information about readmitted patients, which may be detrimental to continuity of~     care and patient safety. The purpose of this study is to determine baseline awareness and~     communication rates among physicians regarding readmissions, and then measure the effect of~     automatic notification on these rates.~   "
229690|NCT00550251|"~     Pilot study completed - power calculation performed. Now formal double blind randomized study~     comparing active with placebo wristbands for nausea in palliative care patients to be carried~     out.~   "
229691|NCT00550238|"~     To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's~     disease psychosis.~   "
229692|NCT00550225|"~     Salt Bridging study for GSK961081~   "
229693|NCT00550212|"~     The purpose of this study is to evaluate the mass balance and metabolic distribution of~     C14-labeled HKI-272 in healthy male subjects.~   "
229694|NCT00550199|"~     This will be a single center phase I dose escalation trial. LBH589 will be administered~     orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days~     1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will~     be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose~     level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a~     specific dose level, then the previous dose level will be considered the recommended phase II~     dose. Dose escalation will continue until the maximum tolerated dose is determined or until~     all dose levels outlined in the protocol have been completed. A total of 10 patients will be~     treated at the dose that is recommended for further phase II evaluation to further assess the~     safety of the combination regimen. Toxicity assessments will be ongoing and disease~     assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue~     on study until disease progression unless toxicity warrants drug discontinuation.~   "
229695|NCT00550186|"~     The purpose of this study is to assess the influence of different fluid infusions on the~     quantity of bladder retention after spinal anesthesia. This study should determine if this~     increase in bladder retention is significant and relevant.~   "
229696|NCT00550173|"~     The purpose of this study is to compare the combination of erlotinib and pemetrexed versus~     either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time~     until the objective worsening of the disease) in patients who have never smoked and have~     locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a~     first-line chemotherapy treatment.~   "
229775|NCT00549133|"~     To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are~     thought to be the possible mechanisms, inducing a generalized vasculopathy associated with~     microalbuminuria and vascular events in type II diabetic hypertensive patients~   "
229776|NCT00549120|"~     Optimising the propranolol block model~   "
229697|NCT00550160|"~     This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal~     intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home~     management of malaria (HMM) programme using AQ+AS in Ghana. The study will be conducted in~     the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be~     randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone.~      The study will run in three phases; a preparatory phase to set up and obtain baseline~     morbidity data from a cross-sectional survey; an intervention phase and a post intervention~     phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study~     children randomly selected will receive three full treatment courses of AS+AQ intermittently~     during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs)~     will administer all courses of IPTc. The first dose of each course will be directly observed~     by the CDDs who will educate mothers or caregivers to administer subsequent doses~     appropriately at home. Follow up visits to homes will be done by CDDs and field supervisors~     to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria~     and other secondary outcomes will be compared with those of another cohort of 546 study~     children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ~     when necessary during the observation period.~   "
229698|NCT00550147|"~     The primary purpose of this thirteen-week, open-label study is to test the hypothesis that~     quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in~     children and adolescents who have shown inadequate response to OROS methylphenidate alone.~   "
229699|NCT00550134|"~     Patients with cancer often complain that their mind does not seem to be clear. This can be~     due to stress, depression, anxiety, or physical problems caused by cancer or the treatments~     used to control symptoms. There are many purposes for this study; one of them is to learn~     about the effects of cancer treatments on the brain, and another is to identify useful tools~     to detect these effects. The results of this study may stimulate new research comparing~     different treatments to the current treatment so the researchers may learn how to treat~     symptoms more effectively and improve patient quality of life. We would also like to learn~     more about the effects chemotherapy may have on DNA.~   "
229700|NCT00550121|"~     In CHF central sympathetic activity is increased. ROS formation seems to play a role in this~     process. This study analyzes the effect of vitamin C as an antioxidant on central sympathetic~     activity in CHF~   "
229701|NCT00550108|"~     The purpose of this study is to determine the natural history of pancreatic cysts and to~     determine if these cysts can be effectively treated with a less invasive therapy (ethanol~     injection vs periodic imaging) rather than surgical resection~   "
229702|NCT00550095|"~     This study is designed to assess the efficacy of the different dosage forms of Valsartan[80,~     160, and 320 mg] in reducing microalbuminuria/proteinuria in hypertensive patients with type~     2 diabetes.~   "
229703|NCT00550082|"~     Evaluation of physician responses to BICS-Clinical Information 3-screen alerts that informs~     the clinician that his/her patient may be eligible for thromboprophylaxis.~   "
229704|NCT00550069|"~     Late preterm infants are at an increased risk for short and long term morbidity (during the~     1st year of life, their neurodevelopmental status may also be delayed as compared to infants~     born at term). The term near term infants is probably a deceiving one.~   "
229705|NCT00550056|"~     The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy~     for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was~     administered by lay counsellors.~   "
229706|NCT00550043|"~     The purpose of this study is to understand the safety and tolerability of INCB018424 in~     patients with rheumatoid arthritis~   "
229707|NCT00550030|"~     Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity~     has been approved for the treatment of moderate to severe psoriasis. However, in a~     substantial portion of cases etanercept does not induce reduction in psoriasis area and~     severity index (PASI) of 75% or greater, now being considered as gold standard for treatment~     efficacy. In this study the researchers aim to determine in a randomized half-side~     comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the~     therapeutic efficacy of etanercept.~   "
229708|NCT00550017|"~     The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493)~     in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate~     (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian,~     renal or breast cancer (in Phase 2 portion)~   "
229709|NCT00550004|"~     This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of~     six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic~     pancreatic cancer. The study will be conducted at approximately 55 sites in the North~     American, Europe, and South America. Approximately 153 subjects will be enrolled in a~     randomization (ratio 2:1).~   "
229710|NCT00549991|"~     High blood pressure is one of the most common health problems in the United States. Genetic~     variations may cause some people to be more susceptible to developing high blood pressure.~     This study will identify variations in genes known to play a part in the development of high~     blood pressure.~   "
229711|NCT00549978|"~     to investigate the safety and pharmacokinetics, in healthy adult male subjects~   "
229712|NCT00549965|"~     Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing~     of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure~     compliance (50 % drug taken), and persistence.~   "
229713|NCT00549952|"~     to survey oral mucositis after chemotherapy and Concurrent chemoradiotherapy in Korean cancer~     patients~   "
229723|NCT00549822|"~     The purpose of this research study is to study the effects of using aromatase inhibitor (AI)~     therapy intermittently on participants with breast cancer. AIs are a class of drugs used to~     treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen,~     which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses~     despite therapy with an AI is thought to have become resistant to AI therapy. There is~     scientific evidence to suggest that resistant breast cancer cells learn to grow at the very~     low levels of estrogen present on AI therapy, and that increasing estrogen levels even~     slightly by stopping AI therapy may inhibit the breast cancer cells.~   "
229714|NCT00549939|"~     The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to~     Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of~     age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O.~      Secondary objectives were:~        -  To investigate the safety and tolerability of two doses of Alfuzosin in comparison to~          Placebo in children and adolescents,~        -  To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on:~             -  Detrusor compliance,~             -  Urinary tract infection,~        -  To investigate the pharmacokinetics of Alfuzosin (population kinetics),~        -  To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day.~      The study consisted of 2 periods:~        -  a 12-week double blind treatment period where patients were to receive either Alfuzosin~          0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then,~        -  a 40-week open label extension treatment period where patients were to receive either~          Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.~   "
229715|NCT00549926|"~     The purpose of this study is to compare the effects of fluvastatin, pravastatin,~     pitavastatin, and atorvastatin on coronary plaque volume in patients with acute coronary~     syndrome, and to clarify the impact of moderate and intensive lipid lowering therapy on~     coronary plaque volume, serum lipids, and inflammation markers in patients with acute~     coronary syndrome in Japanese.~   "
229716|NCT00549913|"~     This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety,~     and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated,~     allogeneic MPCs (NeoFuse) when combined with MasterGraft Resorbable Ceramic Granules~     (Medtronic Sofamor Danek USA, Inc.) compared to autograft in patients requiring posterior~     lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage (to be used with~     autologous bone graft material) and 1 or 2 level posterolateral lumbar fusion surgery with~     instrumentation. The instrumentation used for this study will be the Monarch® 5.50 mm Spine~     System (DePuy).~   "
229717|NCT00549900|"~     A phase I, open label, single-centre study to evaluate the safety and immunogenicity of~     GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM),~     administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female~     subjects aged 15 - 45 years.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
229718|NCT00549887|"~     The purpose of this study is to estimate the direct costs associated with switching, in~     either direction, between a rapid-acting analog therapy and short-acting human insulin~     therapy within the first year following the switch. The additional goals are: 1)to assess the~     impact of a switch from or to a rapid-acting analog insulin therapy on patient treatment~     satisfaction, 2) to assess the impact of a switch from or to a rapid-acting analog insulin~     therapy on patient quality of life, 3) to assess the impact of switch from or to the~     rapid-acting analog insulin therapy on the quality of metabolic control and, 4) to estimate~     the total costs (direct and indirect) associated with switching, in either direction between~     rapid-acting analog and short-acting human insulin within the first year following the~     switch.~   "
229719|NCT00549874|"~     The overall hypothesis to be tested is that increased insulin resistance contributes to~     abnormal cardiac blood flow regulation in type 2 diabetic patients, which can be reversed by~     6 months treatment with rosiglitazone. The planned experimental approach will be to utilize~     nuclear medicine techniques to evaluate whether the administration of rosiglitazone for 6~     months can reverse regional deficits in myocardial blood flow and glucose utilization in type~     2 diabetes in a randomized double blind controlled study. These studies will help elucidate~     the potential of rosiglitazone to correct deficits of myocardial blood flow complicating~     diabetes with the overall aim being the eventual prevention of sudden cardiac death.~   "
229720|NCT00549861|"~     Different studies have shown that fibrosis of the heart increases the risk for a sudden death~     from e.g. arrhythmias. Magnetic Resonance Imaging (CMR) can easily identify even small areas~     of fibrosis in the heart muscle after contrast agent application (Gadolinium). With the~     development of faster scanners and new contrast agents, the detection of small fibrotic areas~     may even be improved.~      In this study, we will apply dedicated T1- and T2-weighted CMR sequences before and after~     administration of Gadolinium-based contrast (Gadobutrol, Gadovist(r)), the study parameters~     will be full cardiac function, areas of edema, areas of inflammation and areas of fibrosis.~      We hypothesize, that we can detect fibrotic areas in the myocardium using Gadobutrol~     (Gadovist (r)) better than with the commonly used Gadolinium-DTPA contrast agents. We also~     hypothesize, that fibrosis of the myocardium is correlated to prognosis of the patients.~   "
229721|NCT00549848|"~     The primary objective of this study (TOTXVI) is to compare the clinical benefit, the~     pharmacokinetics, and the pharmacodynamics of polyethylene glycol-conjugated (PEG)~     asparaginase given in higher dose (HD PEG) versus those of PEG-asparaginase given in~     conventional dose (CD PEG) during the continuation phase.~      This study has several secondary objectives:~      Therapeutic Objectives:~      To estimate the event-free survival and overall survival of children with ALL who are treated~     with risk-directed therapy.~      To study whether intensifying induction, including fractionated cyclophosphamide and~     thioguanine, in patients with day 15 MRD > 5%, will result in improved leukemia cytoreduction~     in this subgroup compared to TOTXV.~      To assess whether intensification of central nervous system (CNS)-directed intrathecal and~     systemic chemotherapy will improve outcome in patients at high risk of CNS relapse.~      Exploratory Pharmacologic Objectives:~      To identify pharmacogenetic, pharmacokinetic and pharmacodynamic predictors for~     treatment-related outcomes in the context of the systemic therapy used in the protocol.~      To compare the pharmacokinetics and pharmacodynamics of PEG-asparaginase given in higher dose~     (3,500 or 3,000 units/m2) versus those of PEG-asparaginase given in conventional dose (2,500~     units/m2) in the continuation phase.~      Exploratory Biologic Objectives:~      To determine the prognostic value of levels of minimal residual disease in peripheral blood~     at day 8 of remission induction.~      To validate new markers and methods for MRD detection. To genotype natural killer (NK) cell~     receptors and measure their expressions at diagnosis and before reinduction, and to associate~     these features with treatment outcome.~      To identify new prognostic factors by applying new technologies to study patient material~     (e.g., stored plasma, serum, cerebrospinal fluid, and normal and leukemic cells).~      Exploratory Neuroimaging Objectives:~      To use quantitative MR measures (Diffusion Tensor Imaging and high resolution volumetric~     imaging) to assess differences in myelin and cortical thickness development in patients~     treated for ALL relative to healthy controls matched for age and gender.~      To assess the impact of folate pathway genetic polymorphisms on myelin and cortical thickness~     development and neurocognitive performance.~      To assess the impact of frontal-parietal lobe myelin and cortical thickness development on~     neurocognitive performance in attention, working memory, fluency, visual-spatial reasoning~     and processing speed.~   "
229722|NCT00549835|"~     This research is being done to see if acupuncture helps relieve mucositis pain in patients~     with leukemia who are undergoing chemotherapy. Many patients receiving chemotherapy develop~     mucositis (painful sores or blisters in the mouth or throat). Mucositis is not only a~     frequent complication in cancer care and extremely painful, but also increases the risks of~     infection and malnutrition and often leads to discontinuing or delaying the chemotherapy~     treatments.~   "
229725|NCT00549796|"~     Angioplasty is a procedure which opens blocked heart arteries using balloons and/or stents.~     Most U.S. states and all national heart organizations require that angioplasty be done only~     at hospitals that can also perform open heart surgery. The reason for this is that there is a~     risk that angioplasty can cause injury to the heart artery that might require open heart~     surgery to fix. Open heart surgery is a backup in case it is needed. The risk that open heart~     surgery will be needed is very small. Nevertheless, without more research, many state~     Departments of Health and all national heart organizations do not want to change the~     requirement for having on-site open heart surgery wherever angioplasty is performed. Some~     States already allow this; and European heart organizations already allow it, as well.~      This study is designed to determine whether the safety and benefits of angioplasty are the~     same at hospitals that perform angioplasty either with or without open heart surgery backup.~      Patient who enter the study have a heart catheterization at a hospital without a heart~     surgery program. If they need angioplasty, then they are randomized to either stay at the~     hospital without heart surgery for their angioplasty or to be transferred for the procedure~     to a hospital with heart surgery. For every four patients, three stay at the hospital without~     heart surgery and one is transferred.~      The study is designed to show that there is no detectable difference between the safety and~     benefits of the procedure at the two types of hospital (with and without heart surgery). The~     cost of the procedure at the two hospital types is also compared.~   "
229726|NCT00549783|"~     This is a study to investigate if patients who have had a stroke and suffer from spasticity~     might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is~     characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and~     can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is~     a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to~     reduce spasticity significantly. Patients will be enrolled in this study at about 33~     locations in Europe and Canada. Study participation will last for about 1 year.~   "
229727|NCT00549770|"~     This study was a dose-ranging efficiacy study in patients with essential hypertension to~     assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and~     placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to~     placebo.~   "
229728|NCT00549757|"~     The purpose of this study was to determine whether, in patients with type 2 diabetes and~     pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at~     a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment,~     reduces death and disease caused by the heart, the circulatory system and the kidney.~      AMENDMENT 4 RATIONALE (MARCH 2012) :~      Protocol amendment 4 served to address the data monitoring committee recommendation dated 14~     Dec 2011 to discontinue study treatment in all participating patients. It also addressed the~     subsequent Health Authorities request to implement a 12 month safety follow-up period (actual~     duration was 9 months in average) post study drug discontinuation.~   "
229729|NCT00549744|"~     Subjects will attend the unit for out-patient visits on Day 1, Day 7, Day 14 and Day 15 of~     each treatment period. The washout period between each treatment period will be a minimum of~     10 days and maximum of 28 days. Subjects will participate in 3 treatment periods.~   "
229730|NCT00549731|"~     The purpose of this study is to create a subject database to recruit for current and future~     studies in research on autism and other neurodevelopmental disabilities.~   "
229731|NCT00549718|"~     Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This~     clinical study is designed to test the hypothesis that lurasidone is more efficacious than~     placebo. The study will also evaluate the safety and tolerability of lurasidone as compared~     to placebo.~   "
229732|NCT00549705|"~     Registry of Hospitalized patients at Brigham and Women's Hospital treated with Fondaparinux~   "
229733|NCT00549692|"~     The purpose of this study is to compare omega-3 fatty acids with placebo for efficacy in~     retardation of increase of serum creatinine(SCr) in IgA Nephropathy~   "
229734|NCT00549679|"~     This study will evaluate the safety and tolerability of the cfor the first time in mild to~     moderate COPD patients.~   "
229735|NCT00549666|"~     A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen~   "
229736|NCT00549653|"~     This study is being conducted to provide initial safety and tolerability data as well as to~     provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered~     in healthy male adults~   "
229737|NCT00549640|"~     Cigarette smoking continues to be a major public health problem. Tobacco dependence~     interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for~     all smokers. A need exists for new medications to treat various aspects of tobacco~     dependence, such as the reinforcing effects of nicotine, relief of nicotine withdrawal~     symptoms and prevention of early relapse. The neurobiology of the effect of methylphenidate~     is similar to that of the reinforcing effects of nicotine. In a small previous study,~     methylphenidate was reported to improve nicotine withdrawal symptoms and short term quit~     rates. Methylphenidate is well tolerated, has low abuse potential, and is less expensive~     compared to other tobacco dependence interventions. ConcertaTM, a long acting preparation of~     methylphenidate, is administered once a day, has similar bioavailability as the generic drug~     administered 3 times a day and has an overall similar or improved efficacy compared to~     generic methylphenidate. We plan to obtain preliminary efficacy data in a randomized,~     placebo-controlled phase II study assessing the effect of methylphenidate in cigarette~     smokers for increasing 7-day point prevalence smoking abstinence at end of treatment and~     7-day point prevalence and prolonged smoking abstinence at 6-months. Critical and systematic~     evaluations of newer, innovative, and well-tolerated treatments to help treat tobacco use and~     dependence will provide a wider choice of therapeutic agents to smokers wishing to become~     abstinent from tobacco use.~   "
229772|NCT00549172|"~     Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of~     function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat~     meniscal tears. Improvements have been reported both after arthroscopy and with conservative~     treatment, however no direct comparison exist. Accordingly, the aim of this study is to~     assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative~     tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised~     trial.~   "
229738|NCT00549627|"~     The aim of the study is to determine the relative effectiveness of the PediGuardTM , a device~     manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for~     reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the~     spine.~      Hypothesis #1 The PediGuardTM will be more accurate for pedicle screw placement as compared~     to other standard manual techniques of similar size of pedicle screw insertion. At least 90%~     of screws placed with the PediGuardTM will be positioned correctly in the pedicle (defined as~     less than 2 mm breach by CT scan). In contrast, only 80% of screws using manual placement~     will be positioned correctly in the pedicle.~      Hypothesis #2 The PediGuardTM will not be inferior to fluoroscopic techniques for pedicle~     screw insertion. Both techniques will achieve at least 90% accuracy in the placement of~     pedicle screws.~   "
229739|NCT00549614|"~     The primary objective of this study is to evaluate whether metabolic modulation improves left~     ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in~     chronic heart failure~   "
229740|NCT00549601|"~     This study used two doses of rivastigmine transdermal patch (5 cm^2, 10 cm^2) to establish~     the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or~     without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5~     mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability,~     convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.~   "
229741|NCT00549588|"~     Polymorphic light eruption (PLE) is a common photodermatosis characterized by the appearance~     of itching, erythema, papules or vesicles on sun-exposed skin. Though etiology is unclear it~     is hypothesized that it is an abnormal immune response to autologous antigens generated by~     ultraviolet radiation (UVR). This randomized, double blinded left-right body side~     experimental comparison study was designed to assess the preventive effect of a sunscreen and~     topical DNA repair enzyme-containing after-sun lotion in PLE.~   "
229742|NCT00549575|"~     Although there is a strong rationale to supplement gravid patients suffering intrauterine~     growth restriction (IUGR) or preeclampsia with Arginine or other nitric oxide donors,~     evidence in the literature has been inconclusive. The current study was designed to determine~     whether oral treatment with L-Arginine, a nitric oxide (NO) donor, would enhance birth weight~     and/or decrease neonatal morbidity in pregnancies with severe vascular intrauterine growth~     restriction (IUGR).~   "
229743|NCT00549562|"~     This 8-week, prospective open-label study will investigate the effectiveness and tolerability~     of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er~     will be well tolerated and efficacious for reducing aggression, self-injury, and irritability~     in adolescents and young adults.~   "
229744|NCT00549549|"~     This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that~     will include an 8-day treatment period followed by a 1-week follow-up period in patients~     experiencing symptoms of an acute exacerbation of gouty arthritis.~   "
229745|NCT00549536|"~     Increased levels of intracellular calcium are thought to diminish maximal cellular response~     to insulin and induce insulin resistance. Also, both hypertension and diabetes are thought to~     be conditions of altered intracellular ionic state. The aim of the present study is to~     investigate the possible effect of oral calcium supplementation on intracellular ions,~     insulin sensitivity, 24-h blood pressure and sodium/hydrogen exchanger activity in patients~     with type 2 diabetes and essential hypertension.~   "
229746|NCT00549523|"~     The study is a 2-stage, double-blind, randomized, placebo-controlled study in which fifty-six~     HIV-positive subjects will be randomized into the first stage. Interim analysis to determine~     continuation to stage 2 will be performed to determine continuation after 8 subjects per arm~     have completed a 24-week dosing regimen.~      Primary objectives are to determine the safety of Lessertia frutescens when used by HIV-1~     infected adults with early disease, and to document the impact of Lessertia frutescens on~     markers of HIV disease progression. Secondary objective is to determine the effect of~     Lessertia frutescens on quality of life in HIV-infected adults and length of infection.~   "
229747|NCT00549510|"~     This will be an open-label, single-dose, non-randomized, five-period crossover study in~     healthy volunteers. The duration of the study will last up to eleven weeks from screening to~     follow-up. PK samples will be taken.~   "
229748|NCT00549497|"~     GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids~     but is also less potent. This study will look at higher doses to confirm the improved safety~     profile.~   "
229749|NCT00549484|"~     Infants who have low platelets and who require a platelet transfusion are included in this~     study. Platelet transfusions are routinely given to infants when their platelet count falls~     below a certain level. The study will look at the amount of platelets transfused. The purpose~     of the study is to evaluate the effect of platelet transfusions on the level of a protein~     (thrombopoietin) which is known to help control platelet production.~   "
229750|NCT00549471|"~     Hypothesis: (1) Treating upper limb hypertonia/spasticity with Botox®, in addition to~     reducing hypertonia/spasticity, will (a) improve global development, (b) improve function~     (passive & active), (c) reduce carer burden and (d) improve quality of life. (2) Early~     treatment with Botox® will have a greater impact on the rate of global development when~     compared to late treatment.~   "
229770|NCT00549198|"~     Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA~     (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily~     regimens. However data from head-to-head randomized trials comparing these two FDCs as part~     of an initial regimen are not available at present. The long-term toxicity profiles of these~     regimens are of particular importance, as treatment of HIV is currently life-long and~     therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen~     maintenance are critical therapy objectives.~      The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the~     modified diet in renal disease (MDRD) equation, a validated estimate of renal function.~   "
229771|NCT00549185|"~     The primary objective is to determine the maximum tolerated dose of SAR3419 and to~     characterize the dose limiting toxicity(ies). Secondary objectives are to determine the~     anti-lymphoma activity, the global safety and the PK profile.~   "
229773|NCT00549159|"~     The purpose of study is to compare the treatment success in the study groups.~   "
229751|NCT00549458|"~     The objective of this randomized controlled trial is to determine whether a standardized~     Pilates exercise program can effectively strengthen pelvic floor muscles when compared with~     conventional pelvic muscle rehabilitation.~      Urinary incontinence is a widespread problem that affects 10-40% of all ambulatory women and~     pelvic floor muscle training is an effective treatment for this problem. However, its~     efficacy is proportionate to the effort expended. Even among women who are diligent with~     pelvic muscle rehabilitation, long term follow-up reveals that benefits are lost in the~     absence of maintenance exercises.~      While this intervention is effective, recent studies demonstrate that long term adherence to~     treatment is low. As compliance appears to be a prerequisite to achieving sustained benefit,~     finding a method of pelvic muscle strengthening that better lends itself to long term~     commitment could prove beneficial.~      The currently popular exercise program, known as Pilates (named after founder, Joseph~     Pilates) consists of a series of low impact, flexibility and muscle toning exercises. The~     philosophy centers around developing core strength which includes strengthening the pelvic~     floor. Its use has been described in the US since the 1920s.4 Five million Americans~     currently participate, as opposed to five thousand ten years ago.5 Given its mainstream~     popularity, Pilates would be an appealing as a therapeutic modality for women experiencing~     pelvic muscle weakness. Currently, there are no studies that assess the efficacy of Pilates~     in increasing pelvic muscle strength.~   "
229752|NCT00549445|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Azithromycin, an~     antibiotic, may be beneficial at reducing the symptoms and severity of the disease. This~     study will analyze previously collected study data to evaluate the anti-inflammatory~     properties of azithromycin and determine how azithromycin affects the frequency and severity~     of COPD exacerbations.~   "
229753|NCT00549432|"~     The purpose of the study is to evaluate the TALENT endoluminal stent-graft system in patients~     with abdominal aortic aneurysms. The TALENT endoluminal stent-graft system is a flexible,~     implantable endoluminal vascular device preloaded in a placement system that is used to~     exclude abdominal aortic aneurysms.~   "
229754|NCT00549419|"~     The purpose of this study is to determine whether the early identification and more precise~     intervention of goal-directed intraoperative plasma volume expansion and catecholamine~     therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal~     vital signs will improve postoperative organ function, in particular renal function, in~     patients undergoing major abdominal surgery.~   "
229755|NCT00549406|"~     The ability to maintain balance and avoid falling is highly dependent on the ability to~     locate objects and architectural features in the environment. This need to continually~     monitor the environment as one moves about in daily life suggests a critical role for visual~     attention, gaze control, and spatial memory, all of which are known to decline with aging. In~     this study, the investigators will test the efficacy of a computer-based visual-training~     program designed to improve the ability to rapidly extract information from the peripheral~     visual field. It is expected that older adults involved in the visual training intervention~     will improve the speed, accuracy, and effectiveness of reach-to-grasp balance-recovery~     reactions evoked by sudden unpredictable balance perturbation.~   "
229756|NCT00549393|"~     The investigators propose to conduct a large clinical study to determine if daily bathing~     with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated~     infections in the Pediatric Intensive Care Unit (PICU).~   "
229757|NCT00549380|"~     The ultimate purpose is to explore potential techniques to exclude aneurysms and provide~     alternative conduit for arterial flow. The single center sponsorship is intended to provide~     the investigators the potential to incorporate improvements in existing technology during the~     course of the study thereby ultimately enhancing the potential for superior medical care of~     patients suffering from these disease states.~   "
229758|NCT00549367|"~     To evaluate the effectiveness of nutrition education and dietary counselling to improve the~     nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA)~     attending an HIV treatment facility in Bangkok Thailand.~   "
229759|NCT00549354|"~     The Bifurcated PowerLink System is intended to provide a permanent alternative conduit for~     blood flow within a patient's abdominal vascular system, which excludes the aneurysmal sac~     from blood flow and pressure.~   "
229760|NCT00549341|"~     The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified~     Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for~     painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that~     treatment will decrease symptom severity and will not have any significant side effects.~   "
229761|NCT00549328|"~     This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small~     molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects~     with advanced (Stage IIIB or IV) non-small cell lung cancer.~   "
229762|NCT00549315|"~     The Valiant stent-graft system is a flexible, implantable vascular stent-graft endoluminal~     device preloaded in a delivery system that is used to exclude thoracic aortic lesions~     (thoracic aneurysms, thoracic dissections, penetrating ulcers, traumatic transections and~     both traumatic and degenerative pseudoaneurysms.~   "
229763|NCT00549302|"~     Study to determine the long term safety of tadalafil in patients with increased blood~     pressure in the blood vessel that carries blood from the right heart to the lungs and to see~     if it will keep the disease from getting worse.~   "
229764|NCT00549289|"~     The purpose of this phase III, open-label study is to determine the safety and tolerability~     of cyclosporine in the treatment of dry eye syndrome.~   "
229765|NCT00549276|"~     This study aims to compare the safty and technical accessibility of linear stapler and curved~     cutter stapler during mid to low rectal cancer surgery.~   "
229766|NCT00549263|"~     This study will test whether the Drug levels in plasma after combination formulation tablet~     dosing (SB797620) and separate formulation tablets dosing (rosiglitazone and glimepiride) to~     Japanese Healthy volunteer would be the same or not.~   "
229767|NCT00549250|"~     Vertical transmission of human papillomavirus (HPV) 6/11 leads to infection in the lower~     airway of neonates. The presence of HPV 6/11 may later cause juvenile onset recurrent~     respiratory papillomatosis (JORRP).~   "
229768|NCT00549237|"~     The aim of this study is to demonstrate the influence of peri-operative nutrition on the~     preservation of lean body mass after gastric bypass, as well as it's influence on~     postoperative complications.~   "
229777|NCT00549107|"~     Pediatric patients, especially infants undergoing open heart surgery have a predictable fall~     in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome~     (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in~     intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely~     used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves~     cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow~     through calcium sensitization of the myocardial contractile filaments and opening of~     potassium channels without increasing oxygen consumption of the heart muscle cells. As the~     myocardium of infants is more calcium dependent than in later life, levosimendan should be of~     special benefit in this age group. The purpose of this study is to investigate whether~     levosimendan is superior to milrinone in preventing LCOS in infants after corrective open~     heart surgery.~   "
229778|NCT00549081|"~     Approximately 10% of all couples will be diagnosed as infertile. The most efficient~     infertility treatment is In-Vitro Fertilization (IVF). One major determinant for success is~     production of an adequate number of oocytes (eggs) from the female in order to finally have~     good-quality embryos and finally acceptable pregnancy and delivery rates. Some women will not~     respond adequately to hormonal stimulation and will only a small number of oocytes.~     Therefore, the chances of finally having a successful delivery are significantly reduced.~     Although the specific definition of this situation is controversial, these patients are~     diagnosed as having low ovarian response. This condition is more prevalent in older IVF~     patients as part of the reproductive aging process; it is possible at any age. Currently, the~     understanding of low ovarian response is limited, and although many therapeutic approaches~     have been suggested, no treatment has been proven significantly efficient.~      DHEA is a pro-hormone produced by the adrenal gland and the ovary. DHEA serum levels become~     lower with age and in some chronic diseases. Therefore, some believe it may be beneficial as~     an 'anti-aging' factor. DHEA pills are available as a food-supplement, without need for~     prescription in the US.~      DHEA is involved in the regulation of follicular growth in the ovaries. In a 2000 report,~     five IVF patients who had low ovarian response were treated with oral DHEA (Casson et al, Hum~     Reprod 2000;15:2129). A small increase in the ovarian response to hormonal stimulation was~     noticed. Barad and Gleicher reported their relatively extensive experience, summarizing~     treatment outcome in 25 IVF low-responders treated with oral DHEA pills (Barad and Gleicher,~     Hum Reprod 2006; 21, 2845). They observed increased increases in fertilized oocytes, normal~     day 3 embryos, and number of embryos transferred after DHEA treatment compared with a~     previous treatment outcome before DHEA.~      Based on this observation, DHEA may appear useful for improving IVF outcome in some patients.~     However, a prospective randomized study on DHEA supplementation for IVF patients was not yet~     published. Our aim is to conduct such a study, focusing on IVF patient with low ovarian~     response.~   "
229779|NCT00549068|"~     To compare the subject satisfaction rating in women treated for postmenopausal osteoporosis~     with Actonel 35mg Once-a-Week for 24 weeks, and receiving feedback information, after 12~     weeks of treatment, based on bone resorption marker results using the NTx Point-Of-Care (POC)~     device, to similar women treated as per regular clinical practice~   "
229780|NCT00549055|"~     To assess effectiveness of Macugen for treatment of neovascular age-related macular~     degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of~     administration and combination with other treatments will also be evaluated.~   "
229781|NCT00549042|"~     This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl), a~     once daily opioid analgesic that can relieve pain. A large number of clinical studies have~     been conducted to test this drug. NMED-1077 is still being tested and is not approved by the~     Food and Drug Administration (FDA) for sale in the United States. OROS® hydromorphone HCl is~     currently approved in Europe to treat chronic pain.~      The purpose of this study is to compare NMED-1077 to placebo to see if NMED-1077 is safe and~     efficacious.~   "
229782|NCT00549029|"~     To observe not only the distribution of single nucleotide polymorphism in genes related with~     pharmacodynamic and pharmacokinetics alteration of statins but also to analyze the~     correlation between these SNPs and the incidence of statins-induced myopathy.~   "
229783|NCT00549016|"~     The ultimate purpose is to explore the potential techniques to exclude aneurysms and provide~     an alternative conduit for arterial flow. The single center sponsorship is intended to~     provide the investigators the potential to incorporate improvements in existing technology~     during the course of the study thereby ultimately enhancing the potential for superior~     medical care of patients suffering from these disease states. The sponsor/investigator~     recognizes and accepts responsibility to notify and receive approval from the agency when~     device modifications are made that may affect patient safety.~   "
229784|NCT00549003|"~     The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic~     test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all~     ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.~   "
229785|NCT00548990|"~     The purpose of the study is to examine whether cardiovascular exercise training improves~     immune responses to vaccination in previously sedentary older adults.~   "
229786|NCT00548977|"~     The proposed study is designed to test the following hypotheses:~        1. Mouse autosomal or X-linked genes which are exclusively expressed in mouse spermatogonia~          are also spermatogonia-specific in human.~        2. Severe spermatogenic defect, especially hypospermatogenesis or SCOS, is caused by an~          intrinsic defect in germ line stem cell or speramtogenia.~        3. Spermatogonia-specific genes are caudate genes for human spermatogenic defect,~          especially for hypospermatogenesis or SCOS.~        4. For a significant fraction of cases with severe spermatogenic defect, the sterile genes~          are transmitted via multifactorial inheritance mode.~        5. For some cases with severe spermatogenic defect, mutations of spermatogonia- specific~          genes may be transmitted in the X-linked recessive, autosomal recessive, or autosomal~          dominant mode.~   "
229787|NCT00548964|"~     As of May 21st, 2012, the purpose of this study is to test the antidepressant effect of~     ketamine when given repeatedly over a period of 1 week, as well as the use of Lithium as a~     relapse-prevention strategy for patients with treatment-resistant depression (TRD) who~     respond to an initial series of ketamine infusions. Ketamine is a Food and Drug~     Administration approved anesthetic (a drug used to produce loss of consciousness before and~     during surgery). Ketamine is not approved for the treatment of major depressive disorder and~     is considered experimental in this study.~   "
229788|NCT00548951|"~     To determine the connection between Social Withdrawal and Sensory Deprivation in elderly~     clients with Alzheimer's Type Dementia (i.e. how providing sensory stimulation might reduce~     social withdrawal).~   "
229789|NCT00548938|"~     The purpose of this study is to determine the safety and efficacy of the combination of~     Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide~     followed by temozolomide given at an extended dose schedule (metronomic schedule) in patients~     undergoing initial surgery for newly-diagnosed high grade glioma.~   "
229793|NCT00548886|"~     Long QT syndrome (LQTS)is a cardiac disorder that may lead to ventricular arrythmias and~     culminate in syncope and/or possible death.~      Recently, researchers have developed a way of discovering patients with LQTS by using low~     doses of epinephrine by a continuous, intravenous infusion in adults. Epinephrine, or~     adrenaline, is produced by our bodies in times of stress. By producing adrenaline, your body~     allows itself to adapt to its stressful environment and take appropriate actions (i.e. fight~     or flight response). By simulating this response with very small amounts of epinephrine,~     researchers have shown prolongation of the QT interval does not occur in normal healthy~     adults. However, adults with confirmed LQTS Type 1 (LQTS-1) will prolong their QT interval~     when given low dose epinephrine. Therefore, this test can act as a safe means of identifying~     adults with LQTS-1 who do not have prolonged QT intervals on their resting EKGs.~      However, LQTS is not just a disease of adults, it affects children as well. Currently the~     standard of care is to obtain resting EKGs on our pediatric patients which can miss those~     patients with concealed LQTS. Those patients, who are old enough, can undergo exercise~     testing. Yet this leaves young children unable to run on a treadmill without a diagnostic~     test.~      Hypothesis: The low-dose epinephrine infusion stress test does not cause prolongation of the~     QT interval in an electrophysiologically normal healthy pediatric population.~   "
229794|NCT00548860|"~     The Objective of this study is to study the safety of FCM in patients with anemia caused by~     Heavy Uterine Bleeding and the Post Partum state.~   "
229795|NCT00548847|"~     The relapse of acute leukemia, MDS and blast phase CML after allogeneic transplantation~     affects approximately 1/3 to 1/2 of all transplant recipients and is the main cause of~     treatment failure. There is currently no effective standard treatment for this condition.~      This study will test the activity and feasibility of using a regimen to boost the immune~     system in order to treat AML, ALL, blast phase CML, and MDS relapse after allogeneic~     transplantation.~   "
229796|NCT00548834|"~     The purpose of this study was to confirm and extend the data from previous studies and to~     demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with~     CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had~     failed at least one DMARD.~   "
229797|NCT00548821|"~     The primary aim of this research protocol is to compare if there is a difference in~     progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy~     regimen in women with locally advanced cervical cancer. The secondary aims are to compare~     quality of life assessment of patients and their carers as well as toxicity profiles both~     acute and late.~   "
229798|NCT00548808|"~     The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily~     injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections)~     on lowering the blood sugar level~   "
229799|NCT00548795|"~     Acute respiratory distress syndrome (ARDS) is a severe lung condition that can result from a~     bacterial infection in the lungs. Viral infections may impair the body's immune system~     response to bacteria, which may lead to more serious lung injury. This study will evaluate~     the association between the immune response and ARDS severity in people who have ARDS plus a~     viral infection.~   "
229800|NCT00548782|"~     This study proposes to evaluate the physiological effects of eating Paleolithic type diet~     (hunter-gatherer's diet) on Type 2 diabetic patients. The diet essentially consists of~     fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be~     randomized into taking either ADA (American Diabetic Association) recommended diet or~     Paleolithic diet for 21 days. The research kitchen will provide all food items and total~     calories in both groups will be adjusted to maintain baseline weight. Blood and urine test~     will be done in the first 3 days, last 3 days and 1 month after the study period to study and~     compare the effects of the two diets on subjects glucose control, lipid profile and other~     parameters of cardiovascular physiology.~      We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will~     result in improvement in above parameters and lead to improvement in glucose control with~     less need for diabetes medicines (either lower doses or fewer medications) to a greater~     extent than in subjects fed with ADA diet, without any change in weight. We also expect a~     beneficial effect on blood vessel function, lipid profiles and blood pressure.~   "
229801|NCT00548769|"~     Sufficient subjects with a confirmed diagnosis of MS (EDSS score of 6.5 or below), will be~     recruited to ensure that 30 subjects (approx. equal numbers of each gender) complete the~     study. Subjects will undergo a screening visit, then four study days, each separated by a~     washout period of at least 7 days, when the different firategrast batches of drug substance~     will be administered, and a follow-up visit.~   "
229802|NCT00548756|"~     The goal of this clinical research study is to learn if your thinking ability (cognitive~     function) will be better preserved by delivering whole brain radiation therapy immediately~     after radiosurgical treatment of 1-3 brain metastases or to carefully observe patients after~     radiosurgery and hold back whole brain radiation therapy until the disease comes back.~   "
229803|NCT00548743|"~     This is a study to assess the impact of introducing screening and planned follow up for~     postpartum depression. All women ages 18 to 45 who speak English or Spanish who come to the~     enrolled community family medicine offices will either be given usual care or screened using~     the Edinburgh Postnatal Depression Screening tool. If the EDPS score is high the women will~     be given the PHQ-9 to more clearly identify the specific likelihood of being depressed. Women~     who are determined to be depressed will be treated with medication or counseling based on the~     preference of the women and their physicians. Women will be followed through nurse initiated~     phone calls and visits to the physicians office.~      Outcomes include the level of depression symptoms, measure of comfort with parenting, and~     satisfaction with partner relationships comparing baseline levels with those at 6 and 12~     months from the usual care and intervention sites. These data will be collected by~     questionnaire. In addition, with the women's permission, medical records will be reviewed.~   "
229804|NCT00548730|"~     The purpose of the study is to compare the three methods of bronchoscopic imaging to~     determine what combination is optimum to identify neoplastic mucosal abnormalities. The~     ability to decrease the rate of false-positive and false negative findings of bronchoscopy~     also will be studied for each spectroscopic technique separately and for their combination.~   "
229882|NCT00547690|"~     The primary purpose of the study is to examine the effect of acupuncture treatment when~     combined with strength training on the motor functional recovery of stroke survivors~   "
229806|NCT00548704|"~     The purpose of this study is~        -  To prevent progression of a lesion caused by anthracycline extravasation into necrosis,~          which would require surgical intervention~        -  To prevent development of deep tissue necrosis and destruction leading to impaired limb~          function and neurological deficit~        -  To prevent postponement of the scheduled cancer treatment due to the treatment of the~          extravasation~   "
229807|NCT00548691|"~     The Objective of this study is to study the safety of FCM in patients with anemia caused by~     chronic kidney failure~   "
229808|NCT00548678|"~     This study will assess platelet function and safety in healthy male volunteers following~     doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac~     and oral aspirin.~   "
229809|NCT00548665|"~     The purpose of this study is to determine the impact of carotid plaque screening on smoking~     cessation and control of other cardiovascular risk factors.~   "
229810|NCT00548652|"~     The purpose of this study is to determine whether treating apathy with methylphenidate or~     medical Crisis counselling will increase adherence to weight loss programs thereby increasing~     their effectiveness~   "
229811|NCT00548639|"~     Diabetes is a growing epidemic within the United States that disproportionately affects~     economically disadvantaged communities like East Harlem. As diabetic patients are at very~     high risk for heart disease, experts recommend an aggressive approach towards using statins~     in people with diabetes. However, statins and other helpful drugs are only effective if~     patients decide to take them. Adherence to this medication is notoriously poor and is~     aggravated by its required life-long use. This study is designed to test the effectiveness of~     a new decision aid in helping diverse, inner-city patients with diabetes understand the risks~     and benefits in taking statins and whether this enhanced decision making process improves~     their adherence to the medication.~   "
229812|NCT00548626|"~     The aim of this study is to evaluate if the early change of needle during EUS-FNA for~     suspected pancreatic cancer allows an earlier preliminary cytological diagnosis of neoplasia.~   "
229813|NCT00548613|"~     The purpose of this research study is to determine if the transplant of a combination of stem~     cells, obtained from the bone marrow of the same patient, is effective for utilization and~     rescue of infarcted myocardium. End points will be the assessment of development of mature~     and stable new blood vessels as well as improvement in cardiac function.~      This, Phase I, single center, prospective, non-randomized, open-label study will evaluate the~     safety and feasibility of use of the proposed combination of autologous stem cells. Potential~     subjects who fulfill clinical and laboratory entry criteria at screening will undergo a~     process of bone marrow aspiration for preparation of the two types of bone marrow-derived~     stem /progenitor cells to use. The two bone marrow-derived cell types will be mixed and~     implanted to patients approximately 2 weeks after bone marrow aspiration. After transplant,~     patients will be have a 3 month follow-up to evaluate safety as well as functional heart~     improvement by analysis of symptoms, myocardial perfusion SPECT, and echocardiography.~      Study population will include adult male and female subjects, ages 18-70, presenting with~     acute myocardial infarction and subjects who have had a recent (within 12 months) myocardial~     infarction and will undergo coronary artery bypass grafting.~      Patients will be divided in two groups:~        -  the first group will enroll patients with acute myocardial infarction whom percutaneous~          coronary intervention restored myocardial flow after 4 hours or greater of the~          initiation of symptoms,~        -  the second group will enroll patients who are candidates for coronary artery bypass~          surgery and had a myocardial infarction in the past 12 months.~      Patients will receive the cell mixture by intracoronary or intramyocardial infusion,~     respectively.~      The rationale of this clinical study is based on the observation that most attempts using~     adult stem cells for myocardial regeneration have utilized a source of bone marrow derived~     progenitor cells with the potential to generate new blood vessel and thus contribute to the~     revascularization of the ischemic tissue. This therapy seems to be adequate but not~     sufficient, since it lacks a source of stem cells capable of differentiating and maturing~     into cardiac muscle cells, thus contributing to the recovery of local contractility. The~     proposed combination stem/progenitor cell therapy to be used in this protocol is aimed at~     contributing cell types capable of regenerating both blood vessels and muscle tissues damaged~     after MI.~   "
229814|NCT00548600|"~     The specific objective of this study is to compare the relative efficacy of the combination~     of a temporary iridium implant plus external beam irradiation versus standard external beam~     irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be~     assessed in terms of local recurrence, survival, and toxicity.~   "
229815|NCT00548587|"~     This is a multi-center, randomized, double-blind, placebo-controlled study to determine the~     safety and tolerability of E5555 in subjects with Acute coronary syndrome (ACS).~   "
229816|NCT00548574|"~     The primary objective of the study was to compare the percentage of subjects in remission~     after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day~     once daily versus placebo~   "
229817|NCT00548561|"~     The purpose of this study is to avoid surgical intervention following extravasation of~     anthracycline chemotherapy out of a vessel into the surrounding tissues.~   "
229818|NCT00548548|"~     This study will compare treatment with bevacizumab in combination with capecitabine and~     cisplatin versus placebo in combination with capecitabine and cisplatin, as first-line~     therapy in patients with locally advanced or metastatic gastric cancer who had not received~     prior chemotherapy for advanced or metastatic disease.~   "
229819|NCT00548535|"~     Aim of the study is to evaluate the reliability of self-reported surgical outcome by~     residents~        -  prospective assessment of postoperative complications done by residents using a~          validated five-scale complication classification~        -  simultanously, complications will be prospectively assessed in the same manner by an~          external clinical nurse~        -  Trial with surgical intervention~   "
229820|NCT00548522|"~     Type 1 diabetic women have a decrease in insulin requirements during early pregnancy.~     Preliminary evidence suggests this decrease may be secondary to the regeneration of~     pancreatic B-cells during pregnancy During the second and third trimesters, insulin~     requirements in Type 1 diabetic women progressively increase until approximately 36 weeks~     gestation at which time there is a plateau, and frequently, a drop in insulin requirements.~     We hypothesize that there is regeneration of pancreatic islet cell mass in Type 1 diabetic~     women during pregnancy. In a cross-sectional study, we will use the acute insulin c-peptide~     response to arginine to determine if pancreatic islet mass increases at 12 and 36 weeks~     gestation. Type 1 diabetic women who are not pregnant, who are at 12 and 36 weeks gestation,~     and who are 6 weeks post-partum will undergo an intravenous arginine tolerance test following~     an overnight fast. If we find that there is regeneration of beta cells it opens the~     possibility that therapy may be directed to the same end for people with Type 1 diabetes.~   "
229821|NCT00548509|"~     To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with~     osteoporosis. One month of menatetrenone therapy enhanced the secretion and~     gamma-carboxylation of osteocalcin. Moderate increases of bone resorption and formation~     markers were observed after 6 months. These changes may contribute to fracture prevention in~     patients with osteoporosis.~   "
229824|NCT00548470|"~     This is an open label pre-post study of the effects of clinical treatment with varenicline on~     1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in~     schizophrenic patients, and 3)psychopathology.in schizophrenic patients,. Patients are~     assessed on subjective and objective measures of smoking , selected cognitive measures, and~     special chemical measures, during baseline testing and during 8 weeks of treatment with~     varenicline ( 1-2 mg/day).~   "
229825|NCT00548457|"~     The aim of this study is to show the frequency of endothelial dysfunction in patients~     suffering from ectatic coronary arteries as compared to those who have normal coronary~     arteries. Should this frequency be significant we would recommend initiating conventional~     treatment in those patients with ectatic coronary arteries as is the practice in patients~     with endothelial dysfunction without ectatic arteries~   "
229826|NCT00548444|"~     This study examines the early immune response to a new vaccine (MVA85A) being developed to~     combat tuberculosis (TB).~   "
229827|NCT00548431|"~     The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and~     antileukemic response during the initial 3 months of individualised therapy of children and~     young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual~     toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used~     in the two-months post-remission treatment phase of lower risk childhood ALL. This will be~     performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m^2)~     every 3rd week. Thus, the trial will also test the feasibility of this particular drug~     combination.~   "
229828|NCT00548418|"~     The purpose of this study is to determine whether the combination of topotecan, cisplatin and~     bevacizumab is effective in the treatment of recurrent or persistent cervical cancer~   "
229829|NCT00548405|"~     The purpose of this study was to establish the efficacy and safety of two different doses of~     alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in~     comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who~     had received an adequate trial of disease-modifying therapies but experienced at least 1~     relapse during prior treatment, and who met a minimum severity of disease as measured by~     magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive~     testing every 3 months.~   "
229830|NCT00548392|"~     The purpose of this study is to determine how long collagen based marker clips remain visible~     by ultrasound after placement in suspicious breast lesions and if collagen based marker clips~     can be reliably identified in the operating room and serve as effective guidance for surgical~     removal of high risk or malignant breast lesions.~   "
229831|NCT00548379|"~     Background: Pneumonia is the leading cause of childhood mortality, accounting for 19% of the~     10.6 million deaths that occur each year1. Case-control studies from Ethiopia2 and India3~     suggest that sub-clinical vitamin D deficiency may increase ten times the risk of pneumonia~     in children. We postulate that controlling childhood vitamin D deficiency has the potential~     to dramatically reduce the incidence of pneumonia and save >700,000 lives each year since~     vitamin D deficiency is widespread in developing countries.~      Aim: To investigate whether 3-monthly oral supplementation of 100,000iu vitamin D reduces~     pneumonia and its consequences among children aged 1-12 months (followed for 18 months),~     living in a deprived area of Kabul, Afghanistan, where >70% of young children are vitamin D~     deficient (<8ng/dl). The effect of vitamin D on the incidence of other diseases, in~     particular diarrhea and rickets will also be investigated.~      Methods: Randomised double-blind placebo-controlled trial: 3000 children will be randomised~     to receive either 6 doses of vitamin D or placebo. The first dose will be given at the start~     of autumn and the second and subsequent doses every 3 months thereafter; children will be~     followed for 18 months. Incidence of pneumonia will be ascertained though weekly home visits~     (active surveillance) and from attendances and admissions at the trial clinic and wards in~     the hospital serving the study area (passive surveillance).~   "
229832|NCT00548366|"~     To determine the relationship between degree of sodium restriction and dietary compliance~     with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a~     county hospital population.~      Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a~     No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams~     sodium per day) in the management of cirrhotic ascites.~   "
229833|NCT00548353|"~     A study to assess safety and PK of an investigational drug in migraine patients during and~     between migraine attacks.~   "
229834|NCT00548340|"~     The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind~     treatment period of VEC-162 as compared to placebo in male and female patients with primary~     insomnia.~   "
229835|NCT00548327|"~     This study will evaluate whether Atomoxetine improves cognition in healthy volunteers as well~     as patients with schizophrenia. Atomoxetine is a drug that has been Food and Drug~     Administration (FDA) approved for Attention Deficit Disorder and allegedly increase the~     amount of the neurotransmitter dopamine in the frontal cortex of the brain.~   "
229836|NCT00548314|"~     The purpose of this study is to determine whether a treatment of full thickness wounds by the~     dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality,~     demonstrated by a significant increase of skin elasticity parameters after 3 months.~      Additionally, an increase of the take of graft and improvement of scar assessment scale, scar~     colour/pigmentation and time to complete wound closure, is expected.~   "
229837|NCT00548301|"~     The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in~     the treatment of dry eye syndrome.~   "
229838|NCT00548288|"~     The aims of the study are to determine whether pamidronate applied locally causes diminished~     periprosthetic bone loss and decreased rate of bone turnover compared to patients receiving~     placebo after cemented total hip arthroplasty (THA). The study design will be prospective,~     randomized, and blind. Periprosthetic bone mineral density (BMD) will be measured with dual~     energy X-ray absorptiometry (DXA) at the total periprosthetic area as well as at seven Gruen~     zones or regions of interest. DXA scans will be performed at one week (baseline), three~     months, and six months postoperatively. Mean values of biochemical markers of bone turnover,~     BMD, and baseline-normalized BMD values will be compared between the bisphosphonate and~     placebo groups at each time point. For all temporal measurements including bone markers, BMD~     and normalized BMD, mean values will be compared across each time point within a given group.~   "
229842|NCT00548236|"~     This study is being done to determine whether a telephone-based counseling intervention can~     help survivors of breast and colorectal cancer increase their weekly physical activity.~     Observational evidence suggests that physical activity after breast and colorectal cancer~     diagnosis decreases recurrence rates. Unfortunately, many people become less active during~     cancer therapy, and a substantial proportion never return to pre-diagnosis levels of physical~     activity. This study looks to see if people who have recently finished chemotherapy for~     breast, colon or rectal cancer can be motivated to increase their exercise by talking to an~     exercise specialist over the phone. The study also looks at changes in mood, fatigue,~     fitness, fat distribution and weight.~   "
229843|NCT00548223|"~     In order to observe the secondary preventive effect of the Dengzhanshengmai capsule on~     ischemic stroke, the investigators hold the large randomized control trial (RCT). 3143~     subjects are included in 83 clinical research centers all over China. The subjects are~     randomly grouped into two groups. The basic therapy included antiplatelet aggregation, stroke~     health education, management of blood pressure, blood lipid and blood glucose, etc. The~     treating group will take the compound Chinese Medicine Deng Zhan Sheng Mai capsule and the~     contrast group will take the placebo for twelve months. Then all of the subjects are visited~     on the 30th, 90th, 180th, 360th day after inclusion. The recurrence of stroke, cardiovascular~     events, and peripheral arterial events are observed.~   "
229844|NCT00548210|"~     The purpose of this research is to demonstrate effectivity of Dermatix in promoting~     maturation of the scar, versus a control region that will be treated with an indifferent~     cream.~   "
229845|NCT00548197|"~     Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated~     with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from~     fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and~     techniques are used.~      Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular~     neovascularization. Its intraocular injection has been increasingly used for treatment of~     choroidal neovascularization (CNV) associated with age related macular degeneration (AMD)~     with fairly good success.Also it has been shown to be effective for treatment of PDR~     complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if~     anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before~     vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting~     in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and~     shorter and lessen the need for intraocular cautery..~      In this study diabetic patients who are candidated for vitrectomy with similar complexity~     scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In~     the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial,~     Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before~     operation.~      During each operation, the number of endodiathermy applications, backflush needle~     applications and the duration of surgery will be recorded by an independent observer. Also,~     type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual~     acuities wil be recorded. all these parameters will be compared in two groups.~   "
229846|NCT00548184|"~     We think that lapatinib will help to shrink your tumor when given prior to the main or~     primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is~     given before the main or primary therapy, it is called neoadjuvant therapy. We will compare~     lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen~     receptor positive (ER positive), estrogen deprivation will also be given to you. Tumors that~     are ER positive have a lot of estrogen receptors found in them. This is also called over~     expression or amplification of estrogen receptors.~      The most important information we will get from this study is to see the response to~     neoadjuvant (treatment given before the main treatment), lapatinib with trastuzumab~     (herceptin) in your tumor tissue sample.~   "
229847|NCT00548171|"~     The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in~     adults 10 years after previous booster vaccination with dTpa in a previous clinical study.~     Only subjects who received the booster vaccination in a previous clinical study are eligible~     for participation in this study. The Protocol Posting has been updated in order to comply~     with the FDA Amendment Act, Sep 2007.~      No new recruitment will be performed in this booster phase (see inclusion criteria)~   "
229848|NCT00548158|"~     We are studying patients with diabetes who under proper medical care and administer an~     approved drug. Our interest is if this drug has any sideeffect on vision and if this drug may~     cause swelling of the retina.~   "
229849|NCT00548145|"~     Some studies suggest that statin medications may be effective against Alzheimer's disease.~     However, this has not been proven. The purpose of this study is to evaluate the efficacy of~     pitavastatin in patients with mild to moderate Alzheimer's disease and hypercholesterolemia.~   "
229850|NCT00548132|"~     We proposed to perform a prospective randomized controlled trial to study the effect of the~     use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of~     central venous catheter care on catheter-related bloodstream infections among patients in two~     Barnes-Jewish Hospital ICUs.~   "
229851|NCT00548119|"~     The objective of this study is to gather additional information regarding the performance of~     NeoCart to fill articular cartilage defects in the knee.~   "
229852|NCT00548106|"~     The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment~     age 0-14 days) will be assigned randomly to receive one of two products, provided in~     identical packages except for the lid color. Neither the investigators nor the parents will~     know which product the infant is receiving.~      The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.~      There will be two study groups, each receiving one of the following formulas:~        1. The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula~          containing partially hydrolyzed whey protein, produced and packaged by Materna~          Laboratories, Maabarot.~        2. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by~          Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging~          identical to the Materna product, except for the lid color~   "
229853|NCT00548093|"~     To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804~     taken daily, as single agent in patients with advanced NSCLC who failed at least one~     chemotherapy + erlotinib.~   "
229854|NCT00548080|"~     Registration study~   "
229856|NCT00548054|"~     In order to assess whether the bivalent killed oral cholera vaccine may be used safely among~     infants who are most at risk for cholera, the investigators need to determine the safety and~     immunogenicity of the killed oral cholera vaccine among infants less than 1 year of age when~     given with the expanded program on immunization (EPI) vaccines including diptheria, pertussis~     and tetanus (DPT), oral polio vaccine (OPV), Hepatitis B vaccines and measles vaccine.~     Furthermore, the investigators also need to make sure that immune interference does not occur~     among all the other vaccine antigens given at the same time. Findings from this study will~     pave the way for the possible use of the killed whole cell oral cholera vaccine (OCV).~   "
229857|NCT00548041|"~     The purpose of the study is to evaluate the feasibility of a rapid HIV testing program in the~     Temple University Hospital(TUH)Emergency Department. We hypothesize that a rapid HIV testing~     program in the TUH Emergency Department is feasible. Patients presenting to the Adult TUH~     Emergency Department with certain conditions will be offered rapid HIV testing. Testing will~     be performed by oral swab using the OraQuick Advance test. Patients will receive post-test~     counseling.~   "
229858|NCT00548015|"~     Hand hygiene prescriptions are the most important measure in the prevention of hospital~     acquired infections. Yet compliance rates are generally below 50% of all opportunities for~     hand hygiene adherence. This study will test the short- and long term effects of two~     strategies for promoting hand hygiene in hospital nurses~   "
229859|NCT00548002|"~     To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard~     treatment, could reduce the high mortality and complication rates in Staphylococcus aureus~     bacteremia.~   "
229860|NCT00547989|"~     Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable~     technique for extended, one sided, breast surgery.~   "
229861|NCT00547976|"~     Inflammation in the vascular wall is important in atherosclerosis and the blockage of the~     artery. The peripheral benzodiazepine receptor is involved in inflammation and in this~     protocol we will attempt to take pictures, using PET camera, of inflammation in patients with~     atherosclerosis and compare those of healthy people.~   "
229862|NCT00547963|"~     The purpose of this study is to determine the effectiveness of two brief counseling sessions~     delivered to emergency department (ED) patients who report conjoint alcohol and marijuana~     use, in reducing injuries and other negative consequences, in comparison to an assessment~     only group.~   "
229863|NCT00547950|"~     In order to observe the influence of the Dengzhan Shengmai Capsule on the endpoint of~     patients with ischemic stroke, we hold the multi-centered prospective cohort study. From~     November 2007 to December 2009, 12000 subjects are included in 200 clinical research centers~     all over China. The subjects naturally formed two cohorts based on taking Dengzhan Shengmai~     capsule or not. The basic therapy included antiplatelet aggregation , stroke health~     education, management of blood pressure, blood lipid and blood glucose, etc. Then all of the~     subjects are visited on the 360th day after inclusion. The recurrence of stroke,~     cardiovascular events, and peripheral arterial events are observed.~   "
229864|NCT00547937|"~     Background: Previous studies present contradictory data concerning obstructive sleep apnea~     syndrome (OSAS), lipid oxidation and nitric oxide (NO) bioavailability. This study was aimed:~     (1) to compare the concentration of 8-isoprostane and total nitrate and nitrite (NOx) in~     plasma of middle aged males with OSAS and no other known comorbidity and carefully matched~     healthy controls of the same age and gender; and (2) to test the hypothesis that nasal~     continuous positive airway pressure (CPAP) therapy, might attenuate oxidative stress and~     nitrate deficiency.~   "
229865|NCT00547924|"~     Severe hypotension during reperfusion in liver transplantation is a frequent adverse event.~     Rare data exist so far about pathophysiology of this phenomenon. The exact role of left~     ventricular function, which might be impaired causing hypotension, has not been elucidated~     during the period of reperfusion.~      Goal of this study is to:~        -  perform transesophageal echocardiography in order to assess systolic and diastolic left~          ventricular function during reperfusion~        -  determine inflammatory mediators in the plasma which could cause left ventricular~          dysfunction~   "
229866|NCT00547911|"~     An experimental drug called L-DOPS increases production in the body of a messenger chemical~     called norepinephrine. Cells in the brain that make norepinephrine are often gone in~     Parkinson disease. The exact consequences of this loss are unknown, but they may be related~     to symptoms such as fatigue, depression, or decreased attention that occur commonly in~     Parkinson disease. This study will explore effects of L-DOPS in conjunction with carbidopa~     and entacapone, which are drugs used to treat Parkinson disease. We wish to find out what the~     effects are of increasing norepinephrine production in the brain and whether carbidopa and~     entacapone augment those effects.~      Volunteers for this study must be at least 18 years of age and able to give consent to~     participate in the study. To participate in the study, volunteers must discontinue use of~     alcohol, tobacco, and certain herbal medicines or dietary supplements, and must also taper or~     discontinue certain kinds of medications that might interfere with the results of the study.~     Candidates will be screened with a medical history and physical exam.~      Participants will be admitted to the National Institutes of Health Clinical Center for two~     weeks of testing. The study will have three testing phases in a randomly chosen order for~     each participant:~        -  Single dose of L-DOPS~        -  Single dose of L-DOPS in conjunction with carbidopa~        -  Single dose of L-DOPS in conjunction with entacapone~      Each phase will last two days, with a washout day between each phase in which no drugs will~     be given and no testing will be performed. In each phase, participants will undergo a series~     of tests and measurements, including blood pressure and electrocardiogram tests. Participants~     who are healthy volunteers will also have blood drawn and will undergo a lumbar puncture~     (also known as a spinal tap) to obtain spinal fluid for chemical tests.~   "
229867|NCT00547898|"~     This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study.~     This study will compare an investigational new drug (crofelemer) to placebo for the control~     of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of~     study drug based on safety and response to therapy and the second stage will evaluate further~     the effectiveness of the optimal dose.~   "
229868|NCT00547885|"~     We wish to compare the effect of long acting vs short acting opioids in chronic non-malignant~     pain. The study opioid is Dihydrocodeine Continus and Dihydrocodeine 30 mg tablets. We~     measure pain relief, health related quality of life, sleep, breakthrough pain and depression~     with validated questionnaires to compare the two treatment arms.~      Hypothesis: The pain relief will be better and more stable with long acting opioids. Quality~     of sleep, breakthrough pain and quality of life will also be improved with long acting~     dihydrocodeine.~   "
229883|NCT00547677|"~     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic~     radiosurgery in treating patients with liver metastases.~   "
229869|NCT00547872|"~     In the present study a cohort of diabetic patients without any symptoms and without known~     coronary artery disease (CAD) will be screened at the investigators' diabetes outpatients~     services. Those with intermediate or high risk will be asked to participate and enrolled.~     They will be seen and followed by the cardiologists in order to provide the best adherence to~     medical therapy. By mean of a randomization process, a group of patients will undergo an~     exercise electrocardiography (ECG) testing while the other group will continue to be~     regularly seen at the investigators' cardiology service. Those patients with a positive~     exercise ECG test will be study by coronary angiography and treated according to the severity~     of coronary lesions by percutaneous stenting or surgery. Both groups of patients will be seen~     every six-eight months for the next three years.~   "
229870|NCT00547859|"~     The purpose of this study is to correlate microcirculatory flow and rectal anaerobe cellular~     CO2 production in patients after cardiac surgery. The hypothesis is that such a correlation~     exists.~   "
229871|NCT00547846|"~     The pharmacological effects of PDC-748 were tested in numerous in vitro and in vivo studies.~     The existing pharmacologic findings suggest that PDC-748 possesses certain inhibitory~     activity to the citric acid- and capsaicin-induced cough reflex in guinea pigs with a~     dose-dependent manner. Furthermore, a previous Phase I/II uncontrolled, dose-escalating study~     has shown PDC-748 to be well tolerated and may help to alleviate daytime cough with a~     dose-responding manner.Hence, PhytoHealth Corporation intends to carry out a Phase II~     investigation to confirm the preliminary findings using placebo in the comparator group, and~     to further investigate PDC-748 with a dose escalating manner to establish the dose-response~     range for its antitussive effect, and if possible, to determine the maximal tolerable dose of~     PDC-748.~      This is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate the~     safety and efficacy of the escalating dose levels of PDC-748 in patients with acute cough.~   "
229872|NCT00547833|"~     Children with language-learning disabilities (LLD) have language and reading skills that are~     weaker than those of typically developing children. In the school-age years, reading is a~     primary means of exposure to new vocabulary for typically developing children. Although these~     children would not be expected to master a new word through a single exposure to it in text,~     children show evidence of partial word knowledge growth (e.g., Wagovich & Newhoff, 2004). The~     purpose of this project is to characterize the partial word knowledge growth of children with~     LLD, in comparison to children with typical language skills. Five forms of partial word~     knowledge (e.g., orthographic, word discrimination, syntactic, emotional content, and general~     semantic domain knowledge) are being measured. The study's hypotheses are that children with~     LLD, like typically developing peers, will demonstrate partial word knowledge growth from~     exposure to unfamiliar words in text, but that they will show a different pattern of growth~     across the five forms of partial word knowledge being assessed.~   "
229873|NCT00547820|"~     Evaluation of urinary sensor that will be activated by the urine during voiding~     cystourethrography in pediatric patients~   "
229874|NCT00547807|"~     Non pharmacological approaches are important in pain control in neonates, specially in term~     healthy neonates. Non-nutritive sucking and swaddling are considered effective strategies for~     pain control in these population, but the effect in their association are not clear until~     now. The hypothesis of the study is that association between non-nutritive sucking and~     swaddling reduces pain scores resulting from venepuncture compared to non-nutritive sucking~     alone.~   "
229875|NCT00547794|"~     The purpose of the study is to determine if the combination of AVJ ablation followed by BiV~     pacing significantly improves functional status and exercise capacity compared to~     pharmacologic rate control in patients with chronic AF and depressed ejection fraction,~     regardless of rate or QRS duration.~   "
229876|NCT00547781|"~     The aim of this study is to performed a randomized controlled trial to evaluate the~     usefulness of preimplantation genetic diagnosis (PGD) in patients with repetitive~     implantation failure. Patients will be prospectively randomized in two groups: standard IVF~     with blastocyst transfer on day-5 and transfer day-5 after PGD for aneuploidy screening for~     chromosomes 13, 15, 16, 18, 21, 22, X and Y. The end points of the study are: Cancellation~     rate; implantation rate and ongoing implantation rate. Inclusion criteria are: patients with~     ≥2 previous IVF failure without clinical or biochemical pregnancy with transfer of at least 2~     good quality embryos per transfer. Exclusion criteria will be uterine abnormalities ,~     abnormal karyotypes, abnormal result in thrombophilia screening and low responder patients~     (less than 4 expected oocytes).~   "
229877|NCT00547768|"~     Compare the effect of a single dose of fexofenadine HCl 180 mg plus orange juice versus~     placebo plus orange juice on the change from baseline (pre-dose) in histamine skin flares.~   "
229878|NCT00547742|"~     To correlate serum proteomics patterns with PET/CT findings to improve cancer diagnosis,~     staging, prognosis, and therapy monitoring.~   "
229879|NCT00547729|"~     Most people with heart failure take a number of medications that work in different ways.~     Patients and their families need to keep track of prescribed medications and follow~     instructions on how much to take and when to take them. Currently, doctors are guided~     primarily by symptoms. The device being studied in this trial (called the HeartPOD™ System)~     monitors heart function from inside your body and alerts the patient and physician of~     necessary changes to your medication.~   "
229880|NCT00547716|"~     Hepatitis C virus infection is the most common blood-borne infection in the United States and~     is a leading cause of chronic liver disease affecting 130 million people around the world. It~     is estimated that 1.6% of the US population may be affected by Hepatitis C infection. The~     only recommended treatment that has been approved for your condition is the use of interferon~     and ribavirin. In patients with chronic Hepatitis C, there tends to be an accumulation of fat~     in the liver. Fatty liver has been associated with failure of treatment.~      The accumulation of fat in the liver has been blamed on a particular type of fat called~     triglycerides. Fish oil, by reducing a type of fat called VLDL, can lower the triglyceride~     concentration by as much as 50 percent or more. This study seeks to determine if the~     administration of fish oil along with standard treatment to patients with Hepatitis C will~     increase the treatment response rates.~   "
229881|NCT00547703|"~     The purpose of this study is to determine if use of Nortriptyline will improve symptoms and~     quality of life in patients who have nonulcer dyspepsia.~   "
229884|NCT00547664|"~     The overall aim of this study is to find out whether Hylenex recombinant (for short, Hylenex)~     in subcutaneous (SC) injection improves the speed and effectiveness of SC opioids in hospice~     patients. Specifically, this study proposes to compare the level of self-reported pain in~     hospice patients started on SC infusions of morphine and hydromorphone (Dilaudid) over the~     initial 8 hours of opioid infusion with and without the preceded co-injection of Hylenex.~     Hospice patients include both home-bound patients as well as those under intensive care in~     hospice houses.~   "
229885|NCT00547651|"~     This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from~     growing. The purpose of this study is to evaluate the effect of amrubicin compared to~     topotecan in the treatment of small cell lung cancer.~   "
229886|NCT00547638|"~     This is a multicenter, prospective, randomized controlled study for the purpose of comparing~     DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The~     objective of this study is to demonstrate whether the incidence of wound closure for~     DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.~   "
229887|NCT00547625|"~     Study to look at safety and effectiveness of different doses of tadalafil on prostate related~     genital/urinary tract problems.~   "
229888|NCT00547612|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using~     [18F]-labeled substance P antagonist receptor quantifier, may be effective in finding disease~     in patients with pancreatic cancer.~      PURPOSE: This phase I trial is studying how well a PET scan using [18F]-labeled substance P~     antagonist receptor quantifier works in finding disease in patients with pancreatic cancer.~   "
229889|NCT00547599|"~     To determine if patients who are distressed over having problems getting or maintaining an~     erection react differently to the medication than those who are not stressed over the issue.~   "
229890|NCT00547586|"~     The primary purpose of this study is to evaluate the safety and dose-response relationship of~     N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects~     with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel~     dysfunction (OIBD).~   "
229891|NCT00547573|"~     Study to determine if tadalafil works better than placebo for Asian men having trouble~     getting or keeping an erection.~   "
229892|NCT00547560|"~     To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in~     healthy elderly subjects.~   "
229893|NCT00547547|"~     RATIONALE: Brassica juncea that contains high amounts of selenium may slow the growth of~     cancer cells. Drugs used in chemotherapy, such as irinotecan and capecitabine, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving high-selenium Brassica juncea together with combination~     chemotherapy may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of high-selenium~     Brassica juncea and capecitabine when given together with irinotecan in treating patients~     with advanced cancer.~   "
229894|NCT00547534|"~     The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded~     to, or that has returned after standard treatment, responds to bortezomib, rituximab and~     bendamustine, and also to see what effects this drug combination have on this cancer.~   "
229895|NCT00547521|"~     To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in~     the absence of an IV loading dose of abatacept~   "
229896|NCT00547508|"~     Study to see how effective different doses of tadalafil are for getting and keeping an~     erection when sex is attempted after a certain number of hours.~   "
229897|NCT00547495|"~     Study to determine how safe and effective tadalafil is for Japanese men taking it when they~     need to get and keep an erection.~   "
229898|NCT00547482|"~     The main purpose of this research study is to investigate whether the TANTALUS II System is~     effective in improving glycemic (blood sugar) control in subjects who have type 2 diabetes~     (high blood sugar) and are overweight. The research will also evaluate the impact on weight~     loss and will study other health conditions related to obesity.~      This research study involves an experimental system. The experimental system is the TANTALUS~     System, which consists of the implantable portion that includes the implantable pulse~     generator (IPG) and three pairs of implantable leads. There are also three external parts~     (items that are used outside your body): the programmer, the charger, and the Patient Wand.~   "
229899|NCT00547469|"~     This study will evaluate the safety and effectiveness of the investigational drug DDP733 in~     treating female patients with IBS-c. A placebo control will be utilized.~   "
229900|NCT00547456|"~     We will determine whether oxygen therapy lowers the level of substances in the blood which~     cause inflammation, which is one of the adverse effects of COPD and whether oxygen improves~     overall well being and quality of life as well as sleep quality.~   "
229901|NCT00547443|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving sorafenib together with high-dose chemotherapy~     and external-beam radiation therapy may kill more tumor cells.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     sorafenib when given together with high-dose carboplatin, paclitaxel, and external-beam~     radiation therapy in treating patients with stage III non-small cell lung cancer.~   "
229902|NCT00547417|"~     To compare men of different races and those with diabetes or depression to white men that do~     not have diabetes or depression but also suffer from the inability to get or keep an~     erection.~   "
229964|NCT00546572|"~     This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC~     and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5~     years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of~     13vPnC 1 year after the initial dose of study vaccine.~   "
229965|NCT00546559|"~     The investigators hypothesized simvastatin and pravastatin may have differential metabolic~     effects in hypercholesterolemic patients.~   "
231549|NCT00525590|"~     The purpose of this study is to determine the effect of the surgical intervention and~     insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic~     brain cancer.~   "
229903|NCT00547404|"~     This research study is a Phase I/II clinical trial. It is done to determine the best doses~     that the investigational drug (P276-00) can be used safely. Investigational means that the~     drug is still being studied and that research doctors are trying to find out more information~     about it such as; the safest dose to use, the side effects it may cause and if it is~     effective for treating relapsed/refractory multiple myeloma.~      A majority of multiple myeloma patients overexpress a protein that plays a role in regulating~     the body's cell cycle called Cyclin D1. The study drug P276-00 is a Cyclin D1 inhibitor under~     investigation in the treatment of solid tumors. The researchers therefore believe that Cyclin~     D1 should be studied as a therapeutic target in myeloma. In this research study, we are~     looking for the highest dose of P276-00 that can be given safely and to see how well it works~   "
229904|NCT00547391|"~     The purpose of this study is to find out if tonsillectomy reduces the short-term risk of~     having an objectively confirmed (sequential changes in serum crp and procalcitonin levels)~     delayed pharyngitis episode among patients suffering from recurrent pharyngitis episodes.~     Other aims are to find out the effect of tonsillectomy to reduce the number of pharyngitis~     episodes or symptoms. Still, the possible disadvantages of tonsillectomy and changes in the~     quality of life after tonsillectomy among these patients are examined.~   "
229905|NCT00547378|"~     The purposes of this study are:~        1. To provide evidence from a randomized controlled trial that InterStim Therapy provides~          better relief of symptoms of OAB than standard medical treatments in current use.~        2. To fulfill the requirements of the FDA-mandated post-approval study of the safety of the~          tined lead using a minimally invasive approach.~   "
229906|NCT00547365|"~     RATIONALE: Antibodies, such as human immune globulin, can block the growth of abnormal cells~     in different ways. Some block the ability of abnormal cells to grow and spread. Others find~     abnormal cells and help kill them or carry cell-killing substances to them. Giving human~     immune globulin may be effective in treating patients with primary amyloidosis that is~     causing heart dysfunction.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of human immune~     globulin and to see how well it works in treating patients with primary amyloidosis that is~     causing heart dysfunction.~   "
229907|NCT00547352|"~     To determine if men with problems getting and keeping an erection prefer treatment with~     tadalafil or sildenafil.~   "
229908|NCT00547339|"~     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic~     body radiation therapy and to see how well it works in treating patients with prostate~     cancer.~   "
229909|NCT00547326|"~     Children with otitis media with effusion will be treated with osteopatic cranial techniques~     or with a placebo treatment. Before and after the treatment audiometric and tympanometric~     measures will take place. This procedure will be repeated 3 times, once a week and every~     session will last for 30-45 minutes. The fourth week, only audiometry and tympanomtry will be~     done.~   "
229910|NCT00547300|"~     The purpose of this study is to compare the tolerability of nebivolol to metoprolol ER in a~     populatoin of patients with mild to moderate hypertension also receiving hydrochlorothiazide~     (HCTZ)~   "
229911|NCT00547287|"~     Study to determine if men from around the world prefer sildenafil to tadalafil.~   "
229912|NCT00547274|"~     The purpose of the study is to compare the lipid-altering effects of MK0767, glipizide, and~     pioglitazone after 12 weeks of treatment.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
229913|NCT00547261|"~     The purpose of this study is to determine the maximally tolerated dose and the dose limiting~     toxicity of this antimitotic, tubulin binding investigational drug for those patients who~     have failed standard anticancer treatments.~   "
229914|NCT00547248|"~     The purpose of this observer blind study is to assess the safety in terms of fever >39°C~     (rectal temperature) and the immunogenicity in terms of antibody response following a booster~     vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children~     previously primed with the same vaccines including a pneumococcal conjugate vaccine~     co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and~     OPV or IPV vaccines. Subjects participating in this study should have received three doses of~     pneumococcal conjugate vaccine in the primary study.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00344318)~   "
229915|NCT00547235|"~     RATIONALE: Collecting the T cells from a donor and transplanting them into a patient may be~     effective treatment for immunodeficiency syndrome and CMV infection.~      PURPOSE: This clinical trial is studying the emergency use of adoptive immunotherapy with~     CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency~     syndrome and CMV infection.~   "
229916|NCT00547209|"~     The main objective of the study is to analyze the influence of nitrous oxide on propofol and~     remifentanil requirements.~   "
229917|NCT00547196|"~     RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor~     umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It also~     helps stop the patient's immune system from rejecting the donor's stem cells. When the stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted~     cells from a donor can make an immune response against the body's normal cells. Giving~     cyclosporine and mycophenolate mofetil before and after transplant may stop this from~     happening.~      PURPOSE: This clinical trial is studying how well four different chemotherapy regimens given~     with or without total-body irradiation before umbilical cord blood transplant work in~     treating patients with relapsed or refractory hematologic cancer.~   "
229918|NCT00547183|"~     Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men~     with diabetes mellitus who have problems getting and maintaining an erection.~   "
229968|NCT00546520|"~     Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the~     effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and~     induced sputum inflammatory biomarkers will be evaluated.~   "
229919|NCT00547170|"~     This study is a randomized, double-blinded, controlled trial comparing two regimens of~     doxycycline for the prevention of infection after surgical abortion. One thousand women~     undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du~     Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5~     days after the abortion. Subjects will be randomized to the standard regimen or to take 200~     mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will~     receive a 7-day course of doxycycline regardless of study group. Subjects will complete~     questionnaires of symptoms, including nausea and emesis in the recovery room after the~     procedure and at a single follow-up visit two weeks later. The primary outcome will be~     infection after abortion, defined below. Analyses will be performed including and excluding~     Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis,~     and other side-effects.~   "
229920|NCT00547157|"~     The purpose of this study is to estimate, with pre-specified precision, the difference in~     local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or~     panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous~     cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this~     trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.~   "
229921|NCT00547144|"~     To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate~     patients with pancreas cancer~   "
229922|NCT00547131|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Collecting fluid samples through a catheter may help doctors find out how well temozolomide~     spreads throughout the brain.~      PURPOSE: This clinical trial is studying temozolomide in treating patients with primary brain~     tumors or metastatic brain tumors.~   "
229923|NCT00547118|"~     1) To examine the efficacy of rimonabant in decreasing weight and metabolic~     parameters/cardiovascular disease risk in people with schizophrenia receiving second~     generation antipsychotics 2) To examine the safety and tolerability of rimonabant as an~     adjunctive agent for decreasing weight and metabolic risk in people with schizophrenia 3) To~     examine the efficacy of rimonabant for neurocognitive impairments in people with~     schizophrenia treated with second-generation antipsychotics (secondary outcome) 4) To examine~     the efficacy of rimonabant for patient perceived health outcomes and quality of life~     (secondary outcome) 5) To test the effect of rimonabant on cigarette smoking, nicotine~     dependence and nicotine craving in people with schizophrenia 6) To examine the effects of~     rimonabant on food satiety in people with schizophrenia~      There is an increasing awareness of the problem of metabolic issues in people with~     schizophrenia and renewed focus on physical health care for this population. There is~     under-treatment, in general, of medical conditions in people with schizophrenia, and~     increased mortality from natural causes. People with schizophrenia are at risk for developing~     obesity due to many factors including inactive lifestyle, poor dietary choices, and side~     effects of the commonly used atypical antipsychotics. Metabolic syndrome has been discussed~     in the cardiology and endocrinology for over two decades, but its prevalence in the mentally~     ill is only now being fully realized. Diabetes mellitus may be twice as prevalent among~     patients with schizophrenia as in the general population and metabolic syndrome is probably~     even more prevalent than diabetes among people with schizophrenia. There is now an~     opportunity to address this serious problem. A new drug, rimonabant, has recently been~     approved in several European and Latin American countries. This drug represents the first of~     a new class of psychoactive drugs witch may improve metabolic problems through decreasing~     appetite drive. This may also help decrease the drive for cigarette use, which is also a~     great problem for people with schizophrenia. Is this a safe and effective treatment in this~     population? This study proposes to test this question in a rapid study, which will develop~     the basis for future work in this important area.~   "
229924|NCT00547105|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Stereotactic body radiation therapy may be able to send x-rays~     directly to the tumor and cause less damage to normal tissue. Giving erlotinib together with~     stereotactic body radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving erlotinib together with stereotactic~     body radiation therapy works in treating patients with locally advanced or metastatic~     non-small cell lung cancer.~   "
229925|NCT00547092|"~     To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after~     treatment with both drugs.~   "
229926|NCT00547066|"~     This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and~     effective for treating ITP.~   "
229927|NCT00547053|"~     The purpose of this research study is to determine if multiple doses of two inhaled drugs~     will help Cystic Fibrosis patients whose lungs are infected with a bacteria called~     Burkholderia dolosa. The names of these drugs are tobramycin solution for inhalation and~     amiloride solution for inhalation. Currently, treating patients with Burkholderia dolosa~     infections is challenging because the bacteria is resistant to antibiotics. Therefore,~     researchers are looking for drugs which, when taken with an antibiotic, will help the~     antibiotic to work more effectively.~   "
229928|NCT00547040|"~     The purpose of this study is to determine the:~        -  Natural history of calcification posttransplantation~        -  Natural history of BMC following renal transplantation~        -  Reverse correlation between calcification score and aortic calcifications following~          renal transplantation~        -  Correlation of IMT, BMC, PWV and biochemical variables~        -  Correlation of IMT, BMC, PWV, biochemical variables and outcome~        -  Predictors of CV disease after transplantation~        -  Predictors of IMT progression, BMC loss and PWV progression after renal transplantation~   "
229929|NCT00547027|"~     The purpose of this study is to determine the effects of a tailored, print-based physical~     activity intervention for patients diagnosed with type 2 diabetes.~   "
229930|NCT00547014|"~     Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or~     capsule. Another purpose is to determine how the drug enters and leaves the blood stream and~     body tissues over time.~   "
229931|NCT00547001|"~     This study will evaluate whether there is a difference in the proportion of women who report~     a worsening severity of their hot flashes between three tapering schedules for one accepted~     HT/ET regimen. Secondarily, we hope to evaluate whether there is a difference in the~     frequency (number of occurrences per week), severity (defined as a subjective scale mild,~     moderate, or severe), and Severity Index (SI, equaling the product of both) of hot flashes~     between three tapering schedules for one accepted HT/ET regimen.~   "
229932|NCT00546988|"~     The study is evaluating whether risk-stratification by the means of a chromosomal aberration~     provides a tool to discriminate between standard and high risk. Risk-adapted therapy is based~     on allogeneic stem-cell transplantation for high-risk subjects instead of a second autograft~     in patients with deletion of chromosome 13 who have an HLA-identical stem cell donor~     available.~   "
229997|NCT00546117|"~     This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid~     in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole)~     will increase the rate of resolution of chronic middle ear fluid in children.~   "
229933|NCT00546975|"~     Nutritional supplementation in postoperative recovery is still debated. Functional impairment~     is known to develop both secondary to inflammatory processes or secondary to reduced~     nutritional intake (e.g. disease induced anorexia). Since major surgery represents a~     traumatic event, surgical patients are at increased risk of malnutrition due to starvation,~     activation of neuroendocrine stress axis, inflammation and the subsequent increase in~     metabolic rate. Gastrointestinal surgery in particular can create additional problems as it~     often directly affects and limits dietary intake postoperatively and these effects frequently~     continue after discharge. Whereas manifest malnutrition occurs in about 15% of general~     surgical patients and in about 40% of oncology patients, postoperative weight loss of 5 to 9%~     occur in all surgical patients during the first two months. Moreover studies have shown that~     the nutritional status generally declines in hospital and both functional and nutritional~     status deteriorate for two months after discharge in malnourished surgical patients.~      Most studies that have investigated nutritional support in the surgical setting have~     concentrated on perioperative or short term postoperative supplementation and focussed on~     in-hospital infection and complication rate.~      Hypothesis I:~      Nutritional intake is decreased after surgery which results in an impaired nutritional status~     which in turn is associated with a decreased functional status. Protein rich nutritional~     supplementation is able to reverse nutritional depletion and restore functionality.~      Hypothesis II:~      Surgical stress leads to inflammation; inflammation - in addition to reduced nutritional~     intake - impairs functional status and increases morbidity. Anti-inflammatory, protein rich~     nutritional supplementation aims to prevent inflammatory complications and therefore improves~     functional status and reduces morbidity. In patients with high risk for inflammation, a~     higher effect of anti-inflammatory oral nutrition on recovery of functional status is~     expected.~      This study aims to determine whether 4 week oral nutritional supplementation and/ or~     specialized nutrients is effective in restoring functional status and reducing morbidity in~     surgical patients.~   "
229934|NCT00546962|"~     The aim of this research study is to collect and store the specimens that are left over after~     patients undergo tests ordered by their physicians. These specimens will be used at a later~     time by researchers in the Pulmonary Division to develop a better understanding of pulmonary~     diseases or for the development of new treatments. Typical research studies that will be~     conducted on the stored tissue, fluid, or bacteria from the patient sample involve obtaining~     bacterial cultures, measurement of inflammatory markers, and examination of the~     characteristics of the tissue. Other similar tests may be done in the future; however, these~     tests have not all been determined at this time. It is important to note that no genetic~     testing will be performed on any samples that are obtained as part of this protocol.~   "
229935|NCT00546949|"~     The purpose of this study is to compare two surgery methods on lumbar spinal stenosis:~     minimal invasive decompression and X-stop. It is a prospective randomized multicenter study~     including patients with lumbar spinal stenosis on one or two levels, and neurogenic~     intermittent claudication. Effect assessment will include measures of pain and self-evaluated~     health condition, a full economical evaluation, and areal measurements (MR imaging and~     roentgen analyses)~   "
229936|NCT00546936|"~     The purpose of this study is to evaluate the change in visual activity of ranibizumab to~     Photodynamic Therapy (PDT)in patients with choroidal neovascularization (CNV) secondary to~     presumed ocular histoplasmosis~   "
229937|NCT00546923|"~     To examine the efficacy and safety of venlafaxine XR in the treatment of physical and~     emotional symptoms in patients with an operationally-defined diagnosis of multisomatoform~     disorder (MSD).~   "
229938|NCT00546910|"~     This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter~     trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6~     through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an~     inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured~     during once or bi-weekly visits, three times per visit-day, by a computer based Continuous~     Performance Test. Following an initial 3-28-day screening and washout phase, patients will be~     assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week~     atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7~     week period at the target dose of 1.2 mg/kg per day.~   "
229939|NCT00546897|"~     This study is designed to test the safety and efficacy of lenalidomide in older patients (age~     > 60 years) with untreated acute myeloid leukemia without chromosomal abnormalities involving~     5q.~   "
229940|NCT00546884|"~     The purpose of this study is to determine whether homeless individuals will complete a living~     will and whether guidance enhances rates of completion and to see whether filling out a~     living will has any impact on the care given at the end of life.~   "
229941|NCT00546871|"~     The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously~     and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with~     IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.~   "
229942|NCT00546858|"~     This study is important in urologic nursing since many patients have interstitial cystitis~     (IC), a condition of frequency, urgency and pain affecting more than 1 million women in the~     United States. The vulva may actually be the site of some of the reported pain in women with~     IC, not the urethra or bladder. IC and vulvodynia can impact one's sexual functioning and~     diminish one's quality of life.~      The purpose of this two-part study is to identify and clinically confirm the presence of~     vulvodynia in women diagnosed with Interstitial Cystitis (IC).~   "
229943|NCT00546845|"~     This study is an investigator-initiated study. The study will be performed as a prospective,~     randomized, controlled multi-center trial to evaluate the safety and efficiency of Xpert~     stents compared to PTA in patients with chronic distal artery occlusions or stenosis~     undergoing catheter revascularization. Patients will be eligible for randomization if they~     are over 18 years old, if they undergo percutaneous catheter revascularization of an artery~     below the knee stenosis/occlusion that is less than 15 centimeters in length. Up to two~     vessels may be treated in this study. All lesions greater than 50% in the below the knee~     artery region have to be treated either with PTA or stenting according to the randomization.~   "
229944|NCT00546832|"~     The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical~     diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of~     the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than~     celecoxib.~   "
229945|NCT00546819|"~     The purpose of the study was to assess the safety, tolerability, and immunogenicity of~     ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.~   "
229966|NCT00546546|"~     Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's~     disease: early immunosuppressants (prescription within the six first months following~     diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid~     failure, in a selected group of patients being at high risk of disabling course. The~     hypothesis is that immunosuppressants given early may improve the disease course during the 3~     following years in this subset of patients.~   "
229998|NCT00546104|"~     The purpose of this study is to find out if dasatinib will safely reduce the size or spread~     of your tumor.~   "
229946|NCT00546806|"~     Whiplash is the most common traffic injury, affecting 83% of people involved in motor vehicle~     collisions. People with whiplash injuries often experience pain and disability that can last~     for a long period. This may subsequently lead to an increased use of the health care system.~     Preventing chronic symptoms is a priority for clinicians, insurers, and policy makers.~     However, there are very few factors that can be changed by treatment to prevent prolonged~     symptoms. Providing effective care at the appropriate time is one aspect that can be changed~     and needs to be studied. To date, no randomized clinical trials have investigated the~     effectiveness of multidisciplinary rehabilitation programs for the management of patients~     with whiplash-associated disorders. Additionally, there is no evidence to suggest whether~     rehabilitation programs are superior to physician-based care at improving whiplash-associated~     symptoms. Thus, there is a need for a randomized trial to determine what program results in~     the best outcomes for patients.~      The purpose of this study is to compare three programs of care that are currently available~     in Ontario for the management of patients with Whiplash-associated disorders.~      The results of this study will demonstrate which of three programs of care is superior in~     improving the physical and mental health of patients with whiplash-associated disorders. The~     results will help guide the development and implementation of effective and cost-effective~     programs of care by informing clinicians, insurers and government on the best rehabilitation~     options for patients with whiplash injuries.~   "
229947|NCT00546793|"~     The purpose of this study is to determine if a subcutaneous (SC) dosing schedule of~     veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy~     of veltuzumab that was previously established when administered intravenously.~   "
229948|NCT00546780|"~     This is a phase 3, open label trial for patients with multiple myeloma in first relapse.~     Trial will compare tanespimycin (KOS-953), in combination with a fixed dose of bortezomib~     versus bortezomib alone.~   "
229949|NCT00546767|"~     The purpose of this study is to evaluate three methods of performing home-based assessments~     in Alzheimer's Disease (AD) prevention trials. The initial in-person assessment will be done~     in the clinic or at home.~   "
229950|NCT00546754|"~     To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage~     during a 3 months treatment.~   "
229951|NCT00546741|"~     The purpose of the study is to determine the effect of metformin on dapagliflozin exposure~     and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally,~     the safety and tolerability of dapagliflozin will be assessed in the presence and absence of~     metformin in healthy volunteers~   "
229952|NCT00546728|"~     The purpose of this study is to compare the effects of exenatide versus metformin on vascular~     health with chronic (3-month) therapy and during a 2-hour period following a meal in patients~     with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater~     degree compared to metformin.~   "
229953|NCT00546715|"~     The primary purpose of this study is to evaluate the safety profile and tolerability of~     single oral doses of daclatasvir in subjects with chronic hepatitis C infection~   "
229954|NCT00546702|"~     To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in~     terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR~     1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26,~     blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes~     mellitus receiving HMR 1964 and insulin glargine.~   "
229955|NCT00546689|"~     Correlation between intestinal parasites and serum level of eosinophils and IgE in~     individuals with HIV or aids attended at clinical hospital of the Botucatu Medical~     School-UNESP~   "
229956|NCT00546676|"~     To determine the clinical effectiveness of telithromycin in the treatment of either CAP or~     AECB in a large population of ambulatory adult patients in a community-based setting.~   "
229957|NCT00546663|"~     This is an open-label pilot study of the safety and tolerability of 7% hypertonic saline~     inhaled twice daily for 14 days in infants with CF, 12 to 30 months of age.~   "
229958|NCT00546650|"~     The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently~     approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and~     to assess the bioavailability relative to the 6 mg subcutaneous injection.~      The secondary objective is to evaluate the safety of NP101 in healthy volunteers.~   "
229959|NCT00546637|"~     To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement~     when added to ongoing alpha blocker treatment.~   "
229960|NCT00546624|"~     This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment~     of patients with generalized anxiety disorder.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
229961|NCT00546611|"~     Verruca vulgaris, otherwise known as the common wart, is caused by the human papillomavirus~     (HPV). Common warts are generally located on the hands and feet, but can also occur elsewhere~     (e.g., any areas of frequent contact). Common warts have a characteristic cauliflower-like~     surface, are typically slightly raised above the surrounding skin and are generally diagnosed~     by visual inspection.The treatment of warts poses a therapeutic challenge for physicians. No~     single therapy has been proven effective at achieving complete remission in every~     patient.This study will aim to evaluate an up-to a three-day course of therapy with 0.05%~     PEP005 Topical Gel.~   "
229962|NCT00546598|"~     This study is being conducted to gather medium and long-term information regarding the~     performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip~     Prosthesis System.~   "
229963|NCT00546585|"~     The purpose of this study is to evaluate the safety, any adverse events or side effects, and~     the body's immune response to an experimental flu vaccine [Inactivated Influenza A/H7N7~     Vaccine] being given in increasing doses. Researchers will try to find the smallest dose of~     flu vaccine needed to cause antibody responses against the flu virus in both single and~     repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years~     old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will~     include obtaining a medical history, physical exam, blood sample collections, and use of~     patient memory aids. The volunteers will be in the study for about 7 months.~   "
229969|NCT00546507|"~     The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical~     diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of~     the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than~     celecoxib.~   "
229970|NCT00546494|"~     This is a study to determine the utility of Effexor® (venlafaxine) in achieving response,~     including time to response, maintaining remission, and time to remission as measured by the~     17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor®~     (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.~   "
229971|NCT00546481|"~     This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the~     correction of anemia in patients with chronic kidney disease who are on dialysis. Patients~     will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin~     3 times per week i.v. according to approved treatment recommendations. The anticipated time~     on study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
229972|NCT00546468|"~     Rationale: For the treatment of early gastric cancer (EGC) in the distal portion of the~     stomach, subtotal gastrectomy and lymph node dissection has been a standard operation. With~     the increasing tendency toward minimally invasive surgery, there has been an effort to apply~     minimally invasive techniques to the treatment of EGC. Laparoendoluminal mucosectomy and~     lesion-lifting gastric wedge resection have been developed for this purpose. However, these~     methods have the disadvantage of limited indications according to the size, shape and depth~     of invasion. Kitano et al. performed the first laparoscopy-assisted subtotal gastrectomy with~     lymph node dissection and manual anastomosis with anterior wall lifting method for a patient~     with EGC. In 1995, Uyama et al. and Nagai et al. performed laparoscopy-assisted subtotal~     gastrectomy with lymph node dissections using an automatic stapler instead of manual~     anastomosis for the gastroduodenal anastomosis. It has been possible to maintain an adequate~     distance from the lesion to the proximal and distal margins of resection, to perform radical~     lymph node dissection, and to achieve excellent postoperative recovery. However, there is a~     very limited evidence of superiority of laparoscopic gastrectomy over open surgery. There is~     only one interim report of randomized clinical trial of comparing laparoscopic gastrectomy~     and open gastrectomy. A well-designed clinical study to prove the benefit and safety is~     definitely needed Objective: to compare Laparoscopy - assisted Distal Gastrectomy (LADG) with~     Open Distal Gastrectomy (ODG) in terms of survival, recovery, pain, complications, and~     quality of life (QOL) Hypothesis: LADG is beneficial in QOL, pain, recovery, complications~     while maintaining equivalent survival with ODG~   "
229973|NCT00546455|"~     Many metabolic complications of obesity are a consequence of abnormal responses of the liver,~     muscle, and fat to insulin actions. Fenretinide may improve the effects of insulin,~     preventing metabolic complications.~   "
229974|NCT00546442|"~     To evaluate the effect of treatment of insulin resistance in the response of chronic~     hepatitis C treatment, mesure as HCV-RNA negative at week 72.~      4.3.2 Objetivos secundarios To evaluate the efficacy and safety of treatment with metformine~     to erradicate the insulin resistance of patients with chornic hepatitis C genotype 1 measure~     as HOMA-IR < 2.~   "
229975|NCT00546429|"~     The purpose of this study is to monitor trochanteric fracture healing and review the~     performance of the ATN system.~   "
229976|NCT00546403|"~     The purpose of this study is to test the effect of modafinil on the negative symptoms, such~     as blunted affect and social withdrawal, of schizophrenic patients and to determine~     modafinil's effect on excessive daytime sleepiness. A secondary purpose of the study is to~     examine the effect of modafinil on cognitive functioning of schizophrenic patients.~   "
229977|NCT00546390|"~     The purpose of this study is to compare a treatment called remote ischemic preconditioning~     (rIP) to no treatment. rIP is a simple treatment that is believed to help patients recover~     better after heart surgery. This treatment involves applying a large blood pressure cuff to~     one leg. The blood pressure cuffs will be inflated for 5 minutes and then deflated for 5~     minutes. This will be done 4 times in a row.~   "
229978|NCT00546377|"~     RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and~     mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can~     block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Giving pentostatin together with combination chemotherapy and rituximab may kill more~     cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of mitoxantrone~     when given together with pentostatin, cyclophosphamide, and rituximab and to see how well it~     works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell~     cancer.~   "
229979|NCT00546364|"~     The purpose of this study is to assess the effect of ixabepilone plus capecitabine or~     docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in~     women. The safety of this combination therapy will also be evaluated.~   "
229980|NCT00546351|"~     SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial~     is to assess safety and tolerability of long-term exposure of lacosamide (previously referred~     to as SPM 927) in subjects with painful distal diabetic neuropathy.~   "
229981|NCT00546325|"~     Primary:~      To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are~     overweight or obese (Body Mass Index (BMI) > 27 kg/m² and BMI < 40 kg/m²), have uncontrolled~     HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti~     Diabetic medications - Metformin (Met) and Sulfonylurea (SU).~      Secondary:~      To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid~     measures, Other measures and changes in quality of life~   "
229982|NCT00546312|"~     The purpose of this study is to evaluate the safety and efficacy of endovascular repair,~     using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic~     aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months~     and annually following implantation, and to determine the proportion of patients who~     experience adverse events during and after the implantation procedure, including~     disease-specific and overall mortality rates.~   "
229983|NCT00546299|"~     Several studies have described the use of supplemental oxygen during exertion or activities~     of daily living (ambulatory oxygen) in study populations that have different characteristics.~     This report, based on specialized randomized controlled trials, characterizes ambulatory gas~     usage among patients with COPD who experience low oxygen levels during activities.~   "
229984|NCT00546286|"~     Evaluate the effectiveness of dorzolamide-timolol (Cosopt®) as first line therapy in reducing~     intraocular pressure in patients with untreated Open angle glaucoma (OAG) or Ocular~     hypertension (OH).~   "
229985|NCT00546273|"~     The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI)~     when administered to healthy adult volunteers, compared to placebo; and determine its safe~     dosage range. An initial evaluation of immune responses to the vaccine compared to placebo~     will also be undertaken.~      In the present Phase I clinical trial, four increasing doses of RUTI will be tested, the~     groups composed by 6 volunteers each. (Total of 24 volunteers). The escalation to a new dose~     to test will be done after the safety of the previous dose has been ensured.~      For each dose of FCMtb to test, each volunteer will be inoculated twice (at day 0 and day 28)~     with RUTI (4 volunteers) or placebo (2 volunteers) and will be followed-up up to 25 weeks~     from the first inoculation. The global length of the study will be approximately 15 months.~   "
229986|NCT00546260|"~     Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous~     intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)~   "
229987|NCT00546247|"~     The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493)~     in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate~     (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian,~     renal or breast cancer (in Phase 2 portion).~   "
229988|NCT00546234|"~     The study's research questions concern the appropriateness of use of tiotropium for patients~     with asthma who are current smokers. It is suggested that patients with asthma who smoke, may~     in fact share similarities with patients with chronic obstructive pulmonary disease (COPD).~     Because of this, the study will determine whether this sub-group of patients would in fact~     benefit from therapy currently approved and marketed for COPD patients.~   "
229989|NCT00546221|"~     The investigators want to find out if their specially designed exercise programme will be~     more successful at helping women with depression to feel better than a basic programme will,~     by measuring the effect the programme has on mood, physical health, and social wellbeing.~     Their specially designed exercise programme will involve physical exertion at the~     participants' chosen level of intensity (how hard the body has to work during exercise), and~     will include motivational support. By contrast, the basic exercise programme will be at an~     intensity recommended by national guidelines, of the type that may be prescribed by a general~     practitioner (GP), and will include no extra motivational support.~   "
229990|NCT00546208|"~     This observational study is aimed at exploring bladder function following temporary~     unilateral low loop cutaneous ureterostomy carried out in newborns suffering from severe~     congenital hydro-ureteronephrosis~   "
229991|NCT00546195|"~     This study will examine the response of white blood cells to bacterial infection in blood~     taken from the umbilical cords of newly delivered infants. The blood samples will be taken~     from both male infants who were carried to term and male infants who were born prematurely,~     and genetic studies will compare these blood samples to samples drawn from healthy adult male~     volunteers. The study is designed to look at the ways in which the immune systems of newborn~     infants respond to bacterial infection.~      Participants in this study will be pregnant Chinese women admitted to the labor ward of the~     Prince of Wales Hospital (Sha Tin district of New Territories, Hong Kong SAR) for normal~     spontaneous delivery. Those with known blood-borne infectious diseases such as HIV and~     hepatitis B will be excluded from this study.~      Cord blood and placenta samples will be collected after the completion of delivery. The~     samples collected for this study will be restricted to male newborns. A comparison group of~     blood samples will be drawn from healthy male adults between 25 and 35 years of age....~   "
229992|NCT00546182|"~     We hypothesized simvastatin may reduce adiponectin levels and insulin sensitivity in~     overweight hypercholesterolemic patients.~   "
229993|NCT00546169|"~     -  Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute)~        -  Evaluation of TachoSil in laparoscopic cholecystectomy~        -  Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy~        -  Pharmaco-economic evaluation~        -  Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany~          (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it~          seems urgent to record data about usage of TachoSil in such procedures. For the time~          being TachoSil is applied in about 2% of the gall bladder procedures.~      Aim is to evaluate a possible patient and procedure profile where TachoSil is most~     beneficial.~   "
229994|NCT00546156|"~     Dose dense chemotherapy, which is the term for Adriamycin and Cyclophosphamide (AC) followed~     by Taxol chemotherapy given every two weeks, is the standard chemotherapy for the treatment~     of ER+ or PR+ breast cancer. In this trial, the standard chemotherapy is being combined with~     bevacizumab. Bevacizumab is an antibody which works differently from the way other~     chemotherapy drugs work. Bevacizumab slows or stops cell growth in cancerous tumors by~     decreasing the blood supply to the tumors by binding to a substance found on cancer cells~     called VEGF (vascular endothelial growth factor). Bevacizumab is approved by the FDA for the~     treatment of colorectal cancer and lung cancer. However, it is not approved for the treatment~     of breast cancer. Another goal of this research is to determine whether we can develop a way~     to identify tumors that will respond well to this study treatment.~   "
229995|NCT00546143|"~     This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild~     to moderate allergic asthma~   "
229996|NCT00546130|"~     The purpose of this study is to examine whether setting test groups of cisplatin + irinotecan~     + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy +~     chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation~     and comparing with historical control or community control is appropriate as the protocol and~     regimen for the phase III clinical trial on extensive-stage disease (ED) small cell lung~     cancer.~   "
229999|NCT00546091|"~     This study will explore the uses of three noninvasive imaging techniques-thermography, laser~     Doppler imaging, and multispectral imaging-to test the blood flow of healthy volunteers. By~     comparing these three techniques, researchers will be able to train these imaging systems to~     better evaluate skin types and blood flow. The study will also test computer programs that~     have been developed to correct for the effects of curvature and body hair on the images.~      Healthy volunteers must be older than 18 years of age and may not have had a history of~     malignant tumors, skin disease, or vascular disease.~      Participants will undergo the following procedures on an outpatient basis:~      Three different types of images taken of the participant s forearm~        -  Thermography infrared thermal imaging to map skin temperature~        -  Laser Doppler imaging low-powered laser imaging to map blood flow in the skin~        -  Multispectral imaging near-infrared light imaging to measure total blood flow and oxygen~          levels in the skin~      A reactive hyperemia experiment, in which multispectral images will be taken of the~     participant s forearm during and after the use of a blood pressure cuff~      A hair removal experiment, in which images will be collected of the participant s forearm in~     separate scans done before and after the hair is removed with a topical hair removal solution~      The entire series of exams will take approximately one hour to perform.~   "
230000|NCT00546078|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. This study will further evaluate induction of immune memory and~     anamnestic responses in women who previously took part in the primary study (580299/001) and~     follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the~     primary study and participation in the follow-up study lasted approximately 6 years. In the~     primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints~     and had sustained antibody responses to both vaccine types over at least 5.5 years of~     follow-up. All subjects from North American study sites that completed the follow-up study~     will be invited to take part in the current study. The study will evaluate the safety and~     immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been~     immunologically primed in the primary study.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
230001|NCT00546065|"~     This is a prospective, randomized, controlled, double-blinded, multi-center trial in a~     parallel-group design. Aim of the study is the evaluation of tumor-free survival after~     ablation (by APC, argon plasma coagulation) of Barrett's mucosa plus esomeprazole versus~     surveillance without ablation in patients cured from Barrett's cancer combined with~     randomization of esomeprazole vs placebo for symptomatic reflux control after successful~     ablation of Barrett's mucosa .~      There are two hypotheses: (1) Consecutive thermal ablation of metaplastic, non-neoplastic~     long segments of Barrett's esophagus (>2cm)plus esomeprazole after successful endoscopic~     therapy of mucosal cancer by means of ER will decrease the incidence of secondary cancer~     (local recurrence and metachronous cancer) by a minimum of 50% compared to acid suppression~     alone without ablation within a 5-years follow-up (primary endpoint). (2) After successful~     ablation of Barrett's esophagus patients need ongoing acid suppression therapy for medical~     control of their underlying reflux disease (secondary aim of the study).~      Duration of the study:~      Patient recruitment period: 3 years. Follow-up period: 5 years. Total duration: 8 years. The~     study is already in the recruitment period.~   "
230002|NCT00546052|"~     To determine if a one year treatment Losartan with or without HCTZ at different dosages have~     an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.~   "
230003|NCT00546039|"~     The purpose of this study is to evaluate safety and mechanisms of possible chemopreventive~     effects of synthetic genistein (BONISTEIN™) in patients with localized prostate cancer~     undergoing laparoscopic radical prostatectomy.~   "
230004|NCT00546026|"~     Women whose pregnancies are at judged to be at risk of a poor outcome from an early delivery~     due to medical problems such as diabetes or high blood pressure, are often very anxious~     during pregnancy, at least until they know they have passed the risk period of premature~     birth (after 8 months). Anxiety itself can have a significant effect on the developing baby,~     on the newborn child and the mother-infant bonding process. We will use a combination of~     pregnancy blood tests and an ultrasound assessment to check on placental function, since~     placental damage is the greatest cause of poor outcome. Most women tested this way will have~     normal results, and so may feel reassured and do better in pregnancy than untested women. The~     benefits may extend after birth to mother-infant bonding, breastfeeding success and a reduced~     risk of postnatal depression. We will randomly select an equal number of women for testing~     and no testing (like tossing a coin, known as a randomized control trial) to be confident~     that any benefits observed are genuine. The potential benefits of our research would be~     substantial for the mental health of many pregnant women, for their newborn and for their~     children as they grow up. The tests are easy to do and would add very little in terms of a~     woman's and in terms of the total costs of prenatal care.~   "
230005|NCT00546013|"~     Conflicting results have been reported concerning the association of pseudoexfoliation~     syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an~     association between AAA and PXF, with no consideration of grade. However, a later study did~     not confirm the association between AAA and PXF. The present study aimed at comparing the~     relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive~     patients.~   "
230006|NCT00546000|"~     A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate,~     0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic~     dermatitis.~   "
230007|NCT00545987|"~     This study will test the safety of a HIV DNA vaccine after it is injected into your muscle~     using an electroporation device (TriGrid™ Delivery System made by Ichor Medical Systems), and~     will test the ability of the vaccine to help your body make antibodies and T-Cells.~      In this study, we would like to learn about the effects that electroporation of the HIV DNA~     has on you and your immune system.~   "
230078|NCT00545064|"~     To evaluate if preservative free cosopt is well tolerated in patients with Open angle~     glaucoma (OAG) or Ocular hypertension (OH) with dry eyes.~   "
230081|NCT00545012|"~     This long-term open label follow-up trial gave pediatric subjects suffering from typical~     absences in CAE or JAE the opportunity to continue levetiracetam treatment after~     participation in the pilot study (study N162) or the double-blind study (study N163). Safety~     and efficacy data were obtained.~   "
230008|NCT00545974|"~     The primary objective of the study is to determine whether memantine is effective in slowing~     the rate of behavioral decline in frontotemporal dementia.~      The secondary objective of the study is to assess the safety and tolerability of long-term~     treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia~     (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in~     frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of~     parkinsonism in frontotemporal dementia.~      The tertiary objective of the study is to determine whether treatment with memantine affects~     changes in weight~   "
230009|NCT00545961|"~     The purpose of this study is to find out whether the children with respiratory infection and~     the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the~     nasal middle meatus benefit from antimicrobial treatment.~   "
230010|NCT00545948|"~     This study assigned subjects to either cisplatin/vinorelbine or cisplatin/pemetrexed~     chemotherapy using a genomic based expression profile to determine chemotherapy sensitivity~     in completely resected early stage non-squamous non-small-cell lung cancer (NSCLC). The~     vinorelbine-sensitive tumors group received Vinorelbine followed by cisplatin, while the~     pemetrexed-sensitive tumors group received pemetrexed followed by cisplatin. The primary~     objective of this trial was to determine whether genomic-based adjuvant chemotherapy~     treatment increased the 2-year progression-free survival rate in completely resected patients~     with NSCLC compared to historic controls. Secondary objectives included: 1) estimation of the~     percentage of completely resected NSCLC tumors that can be adequately analyzed and used to~     direct specific adjuvant chemotherapy; 2) estimation of the proportion of patients who are~     assigned to treatment with vinorelbine and pemetrexed; 3) evaluation of drug sensitivity~     patterns of cisplatin and pemetrexed in both treatment arms; 4) description of the overall~     median survival experience of treated patients; and 5) assessment of patient understanding~     and perceptions of participating in a clinical trial evaluating cancer genomics for adjuvant~     treatment of early stage lung cancer.~   "
230011|NCT00545935|"~     The purpose of the study is to investigate the safety and efficacy profile of a new~     paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African~     children with uncomplicated falciparum malaria.~   "
230012|NCT00545922|"~     The purpose of this study was to examine the efficacy of manualized, short-term group~     cognitive behavioral therapy for COPD patients suffering from clinically significant symptoms~     of anxiety and/or depression.~   "
230013|NCT00545909|"~     This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling~     and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in~     women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group~     which receives bone marker feedback or 2)a group which does not receive feedback on the~     results. The study will also assess patient satisfaction with treatment with once monthly~     Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size~     is 500+ individuals.~   "
230014|NCT00545896|"~     Chronic soft tissue wounds represent a difficult problem for patients and doctors as well.~     Chronic wounds can be caused by internal and dermatological diseases like venous ulcers as a~     consequence of venous insufficiency, arterial ulcers as a consequence of peripheral occlusive~     vascular disease, the diabetic foot stemming from diabetes and other pathologies. A different~     reason for chronic wounds could be prior traumatic injuries (war wounds, traffic~     accidents)not showing a tendency to heal after surgical repair.~      The primary goal in the treatment of chronic soft tissue wounds is to obtain wound closure.~     Usually necrotic tissue is debrided, i.e. surgically removed, to assess the full extent of~     the damage, to detect underlying abscesses or other pathologies causing the non-healing of~     the wound. Wet - to - wet dressings are primarily applied to induce a healing process. As~     second line attempts to obtain closure special dressings like semipermeable films, gels,~     hydrocolloids and calcium alginates are applied. These expensive dressings are associated~     with extended time periods of conservative treatment until closure can be observed.~      A third line after failure of nonoperative treatment is the application of skin graft. This~     involves the operative and anesthesiological risk for an already health wise compromised~     patient with little to no physiological reserve. One should not forget that the majority of~     patients presenting at outpatient clinics with chronic soft tissue wounds are the elderly~     with/without disabling comorbidities.~      The use of extracorporeal shockwaves (ESW) for clinical applications was introduced in~     central Europe more than two decades ago. Extracorporeal shockwave therapy (ESWT)is used in~     the fields of urology, orthopedic surgery, trauma surgery. ESW are associated with the~     induction of neovascularisation and with mechanical stimuli causing proliferation of a large~     number of cells including osteoblasts (Martini L., J Trauma 2006). The exact effects of ESW~     on human cells are currently studied in several centers worldwide. The application of ESWT in~     the above mentioned fields of medicine proved safe, reliable and almost complication-free.~      Our center's experience with ESWT in trauma surgery (Schaden W., Clin. Orthop 2001)and the~     observation that not only the traumatic condition (fracture non-union, etc.), but also the~     surrounding tissue showed favorable tissue healing after ESWT, leads to our hypothesis that~     ESWT might be beneficial for the much larger number of chronic soft tissue wounds. The~     investigators anticipate to induce complete wound healing in a number of defined~     clinical/pathological conditions by ESWT. At the same time efficacy and safety of ESWT will~     be investigated.~   "
230015|NCT00545883|"~     The aim of this study is to gather epidemiological data in a population of GERD patients in~     primary care with a history of erosive esophagitis (less than or equal to 3 years).~   "
230016|NCT00545870|"~     Treatment of diabetic macular edema with perifoveal focal/grid laser coagulation was found to~     be effective saving the visual acuity only in 50% of patients and only 3-14% of treated~     patients had an improved visual acuity postoperatively. The decent results of~     lasercoagulation are associated with potential side effects, as focal scotomas, change of~     color discrimination and development of epiretinal gliosis. The frequency of perifoveal laser~     treatments is anatomically limited in case of diabetic macular edema: after application of~     about 350 coagulates there is no possibility to repeat the laser treatment perifoveolar~     without creating confluent lasercoagulates and causing significant scotomas. In case of~     persistence of edema in spite of complete perifoveal grid coagulation, no standard therapy~     exists. Some previous studies investigated the effect of steroids in patients with diabetic~     macular edema unresponsive to grid laser photocoagulation, but the benefit on the visual~     acuity was only temporary and the intravitreal application was associated with significant~     side effects as cataract progression (up to 50%) and ocular hypertension (up to 20%).~      In the Diabetic Retinopathy Study the 4-years rate for severe vision loss in patients with~     high-risk retinopathy was 20.4 %. In cases of proliferative retinopathy, panretinal (scatter)~     photocoagulation can reduce the risk for development of high-risk retinopathy by 50% over 6~     years. When panretinal lasercoagulation is initiated, about 2000 laser spots are equally~     distributed in all four quadrants. Since panretinal photocoagulation bares risks like loss of~     field of vision, central vision reduction and loss of colour vision, this treatment can not~     be continued unlimited.~      In cases of persisting neovascularisations in spite of panretinal photocoagulation, no~     evidence based therapy exists. There is a high risk for intravitreal bleeding, rubeosis,~     secondary glaucoma with severe vision loss. When fibrovascular proliferation leads to retinal~     detachment, vitreo-retinal surgery might be indicated.~      Now we know that vascular endothelial growth factor (VEGF) is the major angiogenic stimulus~     responsible for increase of vasopermeability, cellproliferation and angiogenesis in diabetic~     retinopathy (DRP). Several studies, evaluating VEGF levels in vitreous, have indicated a role~     for VEGF in diabetic macular edema: vitreous samples of patients with diabetic macular edema~     contain elevated VEGF concentration and VEGF injected in experimental studies results in~     breakdown of the blood-retina barrier.~      There is increasing evidence for a therapeutic role of anti-VEGF drugs not only in~     age-related macular degeneration but also in other diseases as in diabetic macular edema.~     Intravitreal injections have become the most favored treatment procedure for administering~     anti-VEGF drugs.~      The side effects and the decent results of laser treatment on the visual acuity in diabetic~     macular edema led to studies using anti-VEGF therapy. Unpublished study results on the~     aptamer pegaptanib (Macugen™) are promising. A study using the antibody fragment Ranibizumab~     (Lucentis™) in patiens with diabetic macula edema is in progress. Ranibizumab is now approved~     to be used as an intravitreal injection.~      Currently there is one additional anti-VEGF drug already on the market: Bevacizumab~     (Avastin™), which has approved as intravenous infusion for the treatment of metastatic~     colo-rectal cancer. Previous studies have shown that systemic use of Bevacizumab (Avastin™)~     can obtain very promising results on patients with choroidal neovascularisation (CNV) by~     age-related macular degenetration. This drug, a monoclonal full-length antibody, designed to~     bind all isoforms of VEGF is a large molecule. But case reports in patients with CNV caused~     by age-related macular degeneration and with macular edema from central retinal vein~     occlusion indicate that intravitreally given Bevacizumab (Avastin™) is effective in diseases~     originating from the choroids and the retina, too. These findings imply a sufficient~     penetration of the retina by Bevacizumab (Avastin™).~      Based on these new findings and the important role of VEGF in diabetic retinopathy, we~     propose a pilot study for treatment of persistent diabetic macular edema or persisting active~     neovascularistaions following lasercoagulation with intravitreally administered Bevacizumab~     (Avastin™) or Ranibizumab (Lucentis™).~   "
230017|NCT00545857|"~     A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes~     mellitus.~   "
230018|NCT00545844|"~     Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both~     uncontrolled asthma and allergic rhinitis.~   "
230019|NCT00545831|"~     Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal~     disease leading to chronic malabsorption or obstruction, whatever the aetiology.~     Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent~     complication of patients with HPN and an important cause of morbidity and mortality in these~     patients. Moreover, CRBSI often recur after a first treatment of the catheter with a~     combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In~     more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.~      The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis~     on CRBSI recurrence in HPN patients.~      Study population is separated in 2 groups, the first one receiving the Taurolock and the~     second one receiving a placebo. This is a randomized double-blind six-month study.~   "
230020|NCT00545818|"~     The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for~     rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long.~     The primary hypothesis is that the alteration in bone level is equal in patients randomized~     to 6 mm as to patients randomized to 11 mm implants.~   "
247106|NCT00318578|"~     The aim of the study is to evaluate, prospectively, prognosis factors associated with~     convulsive status epilepticus (CSE) in adults hospitalized in intensive care units.~   "
230021|NCT00545805|"~     The intraabdominal fat is associated with insulin resistance, a condition that is in the~     basis of diabetes, metabolic syndrome and some cardiovascular diseases. It is not clear~     whether it is the origin of it or a surrogate marker only. We intend to compare the effects~     of bariatric surgery with versus without omentectomy in morbidly obese people intended to go~     through bariatric surgery, accessing insulin sensitivity by metabolic tests.~      If the visceral fat is causative of insulin resistance, its surgical removal (omentectomy)~     might lead to improvement of insulin action, as seen in animal studies and in one study with~     morbidly obese human volunteers.~   "
230022|NCT00545792|"~     This research study is evaluating a drug called avastin in combination with standard~     radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological~     cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers).~   "
230023|NCT00545779|"~     This single arm study will assess participant preference for monthly Bonviva, versus daily or~     weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis.~     Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or~     risedronate) will answer a questionnaire to identify participants who may benefit from a~     monthly Bonviva regimen. Eligible participants will then discontinue their present~     bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning~     and end of Bonviva treatment, all participants will complete an Osteoporosis Patient~     Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the~     target sample size is 500+ individuals.~   "
230024|NCT00545766|"~     Currently, there are no established 2nd-line or salvage chemotherapy regimens for patients~     with HRPC, many of whom retain an excellent performance status. The antitumor characteristics~     and toxicity profile of vinflunine make it an ideal agent to be investigated in this setting.~     In this Phase II trial, we plan to evaluate the efficacy, toxicity, and feasibility of~     administering IV vinflunine at a dose of 320 mg/m2 q3w as salvage chemotherapy in patients~     with HRPC. The patients will be evaluated for response, survival, and toxicity. If~     significant antitumor activity is demonstrated, further evaluation of this agent either alone~     or combination regimens and at earlier stages of disease will be indicated.~   "
230025|NCT00545753|"~     A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse,~     under actual use conditions in subjects 6 months of age or greater who are infested with~     Pediculosis capitis (human head lice).~   "
230026|NCT00545740|"~     The purpose of this study is to determine whether SPD476 is effective in reducing recurrence~     of diverticulitis.~   "
230027|NCT00545727|"~     Research to date suggests that the selection of lower glycemic index foods, that is, foods~     provoking a slower, more sustained blood sugar response, may result in improved glycemic~     control in youth with diabetes. However, there is currently insufficient data to support~     practice recommendations. The purpose of this pilot study is to test the blood glucose~     response to low and high glycemic index meals in youth with diabetes using continuous blood~     glucose monitoring, and to determine whether the effect of glycemic index differs by regimen~     or diagnosis. In this pilot study up to 42 youth with type 1 diabetes or impaired glucose~     metabolism (elevated fasting glucose, insulin resistance, or type 2 diabetes) will~     participate in 5 days of continuous blood glucose monitoring during which they will receive~     both low and high glycemic index meals. Children will be provided with 1 full day of low~     glycemic index meals and 1 full day of high glycemic index meals in a supervised setting in~     randomized order. Each of these test days will be preceded by a standard evening meal and~     snack. Continuous blood glucose monitoring will also be conducted during regular food intake~     ad libidum away from the clinic, as well as during one day of instructed low glycemic meals~     at home. All food intake, insulin, and blood glucose self-monitoring will be recorded. While~     in the clinic, measures of satiety and acceptability of the food will also be obtained. Data~     analysis will include indices of blood glucose levels and variability.~   "
230028|NCT00545714|"~     This single arm study will assess the efficacy and safety of rituximab in combination with~     fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line~     treatment of participants with CLL.~   "
230029|NCT00545701|"~     The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support~     the immunogenicity data from previous clinical studies.~      Objectives:~        -  To describe the immune response 21 days after each vaccination.~        -  To describe the safety profiles following each vaccination.~   "
230030|NCT00545688|"~     This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in~     female patients with locally advanced, inflammatory or early stage HER2 positive breast~     cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4~     cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin +~     pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of~     840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg~     3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the~     entire pre- and post-surgery period all patients will receive adequate chemotherapy as per~     standard of care, as well as any surgery and/or radiotherapy as required. The anticipated~     time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
230031|NCT00545675|"~     To demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in~     24-week treatment in patients with remission status after Abilify with Depakote in the 6-week~     study of acute mania in patients with bipolar disorder~   "
230032|NCT00545662|"~     The Citicoline Brain Injury Treatment (COBRIT) is a randomized, double-blind, placebo~     controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome~     in patients with complicated mild, moderate and severe traumatic brain injury.~   "
230033|NCT00545649|"~     The study aims to evaluate the effects of adding supervised exercise in supplement to an~     educational self-management program, and to determine which subgroups would gain effects of~     the treatment.~   "
230079|NCT00545051|"~     This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in~     the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will~     be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and~     calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target~     sample size is 100-500 individuals.~   "
230034|NCT00545636|"~     The purpose of the study is to examine if an education program of the medical teams can help~     implementation of of NPO (nothing-per-os)orders in children before anesthesia for ambulatory~     medical interventions under anesthesia and decrease unnecessary long fasting. We shall ask~     parents of such children to fill in a questionnaire regarding pre-anesthesia fasting and~     regular eating and drinking habits. Thereafter, all medical teams involved with the~     administration of NPO orders will receive an educational program to explain and implement the~     NPO orders as are recommended by the American Society of Anesthesiologists. We will examine~     if the educational program was successful in reducing unnecessary long period of fasting, and~     if such a program is not associated with increased rate of delay of cases.~   "
230035|NCT00545623|"~     The aims of the study are to investigate individual, combined and added effects of~     acupuncture and the relaxation response in reducing gastrointestinal symptoms, improving~     medication adherence and quality of life among people living with HIV/AIDS. The study will~     also explore the mechanism of these therapeutic effects of acupuncture and the relaxation~     response.~   "
230036|NCT00545610|"~     The purpose of this 12-month, observational, follow-up study is to collect additional data~     (by telephone contact) with which to assess the efficacy, safety, and effects of~     intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in~     subjects with chronic refractory myocardial ischemia. No treatments will be administered~     during this study. However, the investigators and other study site personnel and the subjects~     will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so~     as to provide a total of 24 months of blinded data.~   "
230037|NCT00545597|"~     Study of the use of Lorenzo's oil in adults with adrenomyeloneuropathy, the adult form of~     Lorenzo's oil.~   "
230038|NCT00545584|"~     To compare the efficacy of three strategies of lifestyle changes associated with Januvia~     (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately~     controlled by metformin (hemoglobin A1c [HbA1c] 6.5-9%). A difference between the three~     strategies of lifestyle changes was expected.~   "
230039|NCT00545571|"~     This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and~     tolerability of once-monthly intravenous administration of Mircera in hemodialysis~     participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin~     alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting~     dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating~     agent [ESA] dose administered on Week -1). Subsequent doses will be adjusted to maintain~     hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter~     [g/dL] for Switzerland and 10 to 12 g/dL for Austria).~   "
230040|NCT00545558|"~     The purpose of this study is to measure the effects of anti-HIV drugs on hepatitis C virus~     (HCV) viral load in people infected with both HCV and HIV.~   "
230041|NCT00545545|"~     Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of~     Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan~     therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive~     colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.~   "
230042|NCT00545532|"~     This 2-arm study will investigate the safety and tolerability of oseltamivir for the~     treatment of influenza in immunocompromised participants and characterize the effects of~     oseltamivir in immunocompromised participants on the development of resistant influenza~     virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be~     randomized to receive either conventional dose (30 milligrams [mg]-75mg twice daily orally~     [po], depending on age and weight) or double dose (60mg-150mg twice daily po depending on age~     and weight) Tamiflu for 10 days. Nasal and throat swabs will be taken, and safety evaluations~     made, at intervals during the study. The anticipated time on study medication is 10 days and~     the anticipated time on study is 40 days.~   "
230043|NCT00545519|"~     To determine the maximum tolerated dose and dose limiting toxicity of thymoglobulin in~     multiple myeloma patients.~      To determine the overall response rate (CR+PR) of patients with relapsed or refractory~     multiple myeloma treated with Thymoglobulin.~      To determine the time to response, duration of response, and time to progression and overall~     survival of patients treated with Thymoglobulin.~      To determine the safety and tolerability of Thymoglobulin in these patients.~      To assess the changes in lymphocyte apoptosis and apoptotic signaling in treated patients.~   "
230044|NCT00545506|"~     Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound~     infections~   "
230045|NCT00545493|"~     Rasmussen encephalitis (RE) is a rare but severe chronic inflammatory brain disease of~     unknown origin affecting one brain hemisphere. It is usually accompanied by intractable~     epilepsy. In addition, it often leads to severe disability due to functional deficits caused~     by atrophy of one brain hemisphere. Hemispherectomy is an effective means of surgical~     treatment of the epilepsy. It renders the patient, however, hemiplegic, hemianopic and (if~     the language dominant hemisphere is affected) aphasic. To slow down or even stop the~     progressive inflammatory damage to the affected brain hemisphere, immunotherapies may be~     beneficial. According to a literature survey, tacrolimus (twice daily intake of capsules) and~     intravenous immunoglobulins (monthly infusions) are the most promising compounds for this. In~     the investigators' study, these two types of treatment are randomly assigned to patients with~     disease onset within the last year and not too far advanced disability or hemispheric brain~     injury. The patients are followed to assess prospectively the functional and brain MRI course~     of the disease.~   "
230046|NCT00545480|"~     This 2 arm study will assess the impact of bone marker feedback, using blood sampling and~     communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women~     with post-menopausal osteoporosis. The study will also assess safety, quality of life and~     patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be~     randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study~     treatment is 3-12 months, and the target sample size is 500+ individuals.~   "
230047|NCT00545467|"~     The purpose of this study is to determine whether moderately ill Asian schizophrenic patients~     can be switched from their previous antipsychotic medication to aripiprazole with minimal~     adverse clinical consequences, and elucidate both pharmacokinetic and pharmacodynamic factors~     associated with clinical efficacy of aripiprazole.~   "
230048|NCT00545454|"~     The primary objective of this study is to assess the reduction of systemic inflammation as~     measured by serum levels of C-reactive protein (CRP).~      The secondary objectives are:~        -  to assess the reduction of systemic inflammation as measured changes in acute phase~          protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American~          College of Rheumatology response rate, and morning stiffness duration;~        -  to assess the effect on pain relief within first 14 days;~        -  to obtain evidence of the safety and tolerability of SSR150106;~        -  to document trough plasma levels of SSR150106 and its first metabolite.~   "
230049|NCT00545441|"~     The purpose of this study is to determine whether the Surgisis anal fistula plug is just as~     effective in healing anal fistulas as compared to the advancement flap procedure.~   "
230050|NCT00545428|"~     The purpose of this study is to evaluate the safety and efficacy of mastoid bone autograft~     for dorsal nasal augmentation in rhinoplasty.~   "
230051|NCT00545415|"~     The aim of the study is to compare the effect of consumption of a fruit beverage on plasma~     antioxidant capacity with that of the consumption of fruit.~   "
230052|NCT00545402|"~     This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment~     regimens in de novo liver transplant patients. Patients will be randomized into one of two~     groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to~     exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed~     dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day~     0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
230053|NCT00545389|"~     Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for~     three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).~   "
230054|NCT00545376|"~     There is a high prevalence of asthma in southwest Virginia and there are multiple osteopathic~     manipulative techniques (OMT) which are thought to improve lung function. However, there are~     inadequate studies regarding the effectiveness of using osteopathic manipulative treatment~     (OMT) as an office treatment or a home treatment to address obstructive lung disease. In~     addition, there is little information on the level of acceptance, use, and cost effectiveness~     of using OMT in rural southwest Virginia. The purpose of this study is to determine the~     viability of OMT treatment with asthma, the level of acceptance in selected clinics in~     southwest Virginia, and the effectiveness of home OMT education in order to implement a~     program to improve asthma control. The study hypotheses are: 1. Osteopathic manipulation~     delivered to the asthmatic patient will significantly improve spirometry values, thoracic~     excursion, and subjective asthma symptoms. (.05 alpha) 2.Patients who are taught and use a~     home treatment regime for asthma will significantly improve spirometry values, thoracic~     excursion, and subjective asthma symptoms after two weeks, compare with those who do not have~     home treatment.~      3.Physicians educated on the use of OMT for asthma will increase their perceived future use~     of OMT as an adjunct to treat this disorder.~   "
230055|NCT00545363|"~     This 2 arm study will assess the impact of bone marker feedback (BMF), using serum~     carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on~     adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with~     post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants~     will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The~     anticipated time on study treatment is 3-12 months.~   "
230056|NCT00545350|"~     1. Primary objective: to evaluate the effectiveness of a fall prevention exercise program~          in preventing falls resulting in fractures and other physical traumas.~        2. Secondary objectives:~             -  to better understand the mechanisms by which physical exercise prevents falls and~               ensuing injuries (improvement in physical functional abilities, global physical~               activity level, general physical and psychological wellbeing and self-confidence).~             -  to determine the individual factors associated with long-term adherence to the~               exercise program.~   "
230057|NCT00545337|"~     To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in~     terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR~     1964) in subjects with type I diabetes mellitus~   "
230058|NCT00545324|"~     In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective~     as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction~     over a 6 week comparison period.~   "
230059|NCT00545311|"~     This study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses~     of the NVA237 in mild and moderate COPD patients .~   "
230060|NCT00545298|"~     This study will test the safety and efficacy of nitric oxide gas in the treatment of venous~     leg ulcers~   "
230061|NCT00545285|"~     There are two distinct aims of this study:~        1. This prospective study is designed to document the long-term (10-year) radiographic and~          clinical outcomes of a new type of highly cross-linked polyethylene liner which contains~          vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty~          subjects. The clinical outcome of E-Poly will be compared to a group of subjects~          receiving Arcom XL polyethylene.~        2. This study is also designed to document the long-term (10-year) radiographic and~          clinical outcomes of a new cementless acetabular component having a titanium porous~          surface (Regenerex). The clinical outcome of this new FDA cleared device will be~          compared a group of subjects receiving an acetabular component having a plasma sprayed~          surface.~   "
230062|NCT00545272|"~     This study will evaluate the dose response relationship among four doses of indacaterol as~     well as placebo delivered via the TWISTHALER® device.~   "
230063|NCT00545259|"~     The study will evaluate the pharmacokinetic profile of AEB071 in the immediate~     post-transplant period in patients who have undergone their first liver transplant.~   "
230064|NCT00545246|"~     The primary objective of this study is to determine the dose of aflibercept to be further~     studied in combination with docetaxel in Japanese cancer patients.~      The secondary objectives of this study are to assess the safety profile of aflibercept, to~     determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor~     effects.~   "
230065|NCT00545233|"~     This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without~     concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with~     genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to~     receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body~     weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily~     for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day +~     pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years,~     and the target sample size is 100-500 individuals.~   "
230066|NCT00545220|"~     Vision loss can result in feelings of frustration, helplessness, anxiety, depression, and~     anger, which compromise a person's activities of everyday living. While emotional distress~     may resolve in some persons without intervention, unmanaged and persistent distress places~     the person at risk for continued decrements in health status and the potential development of~     more severe conditions (i.e., depression, poor health outcomes). Persons with low vision will~     be recruited and randomly assigned to either an innovative, problem-solving training (PST)~     intervention group designed specifically for persons with low vision or a sham~     intervention/control group. Primary and secondary outcomes will be assessed at baseline prior~     to intervention and at 3 month follow-up, 7 month follow-up, 12 month follow-up, and 24 month~     follow-up by a research interviewer masked to participants' randomization. This project will:~     (1) demonstrate how specified physical and emotional outcomes of persons with low vision~     change across time, (2) evaluate the effectiveness of a PST intervention that will be~     delivered to persons with low vision; and (3) identify persons with low vision who are at~     risk for adverse emotional and health outcomes.~   "
230067|NCT00545207|"~     This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on~     parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral~     density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly,~     and measurements will be taken at baseline, and at intervals over 2 years. The anticipated~     time on study treatment is 2+ years, and the target sample size is 100-500 individuals.~   "
230068|NCT00545194|"~     The aim of this study is to compare two different preparation~   "
230069|NCT00545181|"~     Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations~     in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of~     adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal,~     nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and~     transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the~     membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and~     postpartum endometritis. Several studies have documented increased postpartum complications~     in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite~     common despite treatment. Documented recurrence rate of up to 30% within three months are~     reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic~     regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic~     therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an~     acidifying gel will decrease the chance of recurrence of BV within 3 months.~   "
230070|NCT00545168|"~     A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse,~     under actual use conditions in subjects 6 months of age or greater who are infested with~     Pediculosis capitis (Head lice).~   "
230071|NCT00545155|"~     The purpose of this study is to: 1) evaluate the reliability and validity of EMS screening~     for depression and cognitive impairment and 2) to develop a pilot ED intervention program to~     address the needs of older adults found to be at risk for depression and cognitive~     impairment.~   "
230072|NCT00545142|"~     To demonstrate the efficacy and safety of co-administration of Abilify(aripiprazole) with~     Depakote(divalproate) in the acute phase of 6-week treatment of acute mania in patients with~     bipolar disorder.~   "
230073|NCT00545129|"~     The purpose of this study is to investigate the safety and efficacy of tanezumab in~     combination with opioids in treating pain due to cancer that has spread to bone.~   "
230074|NCT00545116|"~     The primary objective of this clinical trial is to determine the effects of hesperidin on~     biochemical markers of bone in post-menopausal women.~      The secondary objectives are:~        -  To investigate changes in bone formation and bone resorption markers in response to~          hesperidin intake~        -  To compare the efficacy of hesperidin in a milk versus biscuit~        -  To collect safety information of hesperidin consumption in a human trial~   "
230075|NCT00545103|"~     The purpose of this study is to determine whether SPD476 is effective in reducing recurrence~     of diverticulitis.~   "
230076|NCT00545090|"~     This single arm study will continue drug safety surveillance, and assessment of adherence, in~     patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930,~     the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive~     Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study~     treatment is 3-12 months, and the target sample size is 500+ individuals.~   "
230077|NCT00545077|"~     Locally advanced or metastatic breast cancer in postmenopausal women with negative HER2, who~     are candidates for hormone treatment and who have not received previous chemotherapy or~     hormonotherapy for the metastatic disease.~      The main endpoint of the study is PFS. It has been calculated that 378 patients will need to~     be included, according to the following assumptions:~        -  Recruitment period of 21 months.~        -  Minimum follow-up period of 9 months.~        -  PFS of 9 months in the control arm (letrozole in monotherapy). Using a two-sided~          log-rank test, for a 5% α level, 344 patients (172 in each treatment arm) will be~          required for 270 events to occur, which will provide an 80% power for detecting a hazard~          ratio of 0.69 (corresponding to a PFS median of 13 months in the bevacizumab arm). This~          sample size has been adjusted for an intermediate analysis when 2/3 of the total of~          required events have occurred. This intermediate analysis can be avoided if, at the time~          in which it must be carried out, it is estimated that the final analysis will be carried~          out in 4 months.~      Taking into account a 10% percentage of losses, 378 patients are expected to be included in~     the study.~      An intermediate safety evaluation will be carried out when 63 patients have finished their~     treatment in each treatment arm.~   "
230082|NCT00544999|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells~     more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin~     may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with cytarabine and daunorubicin in treating patients with relapsed acute~     myeloid leukemia.~   "
230083|NCT00544986|"~     The overall objective of the clinical study is to assess the tolerability and clinical~     efficacy of anastrozole in post-menopausal women with hormone sensitive advanced breast~     cancer in India.~   "
230084|NCT00544960|"~     This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and~     safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung~     cancer~   "
230085|NCT00544947|"~     Spinal Administration of opioids offers segmental analgesia, but has side effects including~     pruritus, nausea and vomiting, urinary retention, hypotension, and respiratory depression,~     both early and delayed. Many Centres in the UK now routinely use supplementation of spinal~     anaesthesia from bupivacaine with intrathecal fentanyl or diamorphine. If Fentanyl is used,~     this is usually accompanied by connection to a i.v. Morphine patient-controlled analgesia~     (PCA)-device in the postoperative period, whereas the use of intrathecal diamorphine seems to~     result in a reduction in post-operative morphine requirements, which has obviated the need~     for PCA devices in many centres. There has been recent controversy over which opioid is safer~     to use with regards to the risk of respiratory depression.1,2 The investigators want to~     investigate, whether intrathecal diamorphine causes less or more post-operative respiratory~     depression in healthy mothers undergoing elective caesarean section than intrathecal fentanyl~     plus post-operative morphine PCA.~   "
230086|NCT00544934|"~     A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple~     dose levels of GLY-230 in healthy and diabetic subjects~   "
230087|NCT00544921|"~     To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by~     mouth.~   "
230088|NCT00544908|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with~     stage IV pancreatic cancer.~   "
230089|NCT00544895|"~     NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic~     groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal~     brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage~     mainly observed in preterm newborns. (Copy from www.neobrain.eu)~   "
230090|NCT00544882|"~     This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen~     DR-1021.~   "
230091|NCT00544869|"~     To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral~     administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated~     administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient~     (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume~     expansion despite conventional diuretic therapy.~   "
230092|NCT00544856|"~     A recent meta-analysis that included over 29.000 individuals found that the odds ratio (OR)~     of individuals with high brain reserve compared to low was 0.54 (p < 0.0001), a risk decrease~     of 46%. Among the factors that influence cognitive reserve, mentally stimulating activities~     was the most robust factor after controlling for education, age, occupation and other~     potential confounds. The brain reserve effect was sustained over a median longitudinal~     follow-up of 7 years. It would be interesting to detect whether a complex cognitive training~     could show similar effects on the cognitive abilities of patients with mild Alzheimer's~     disease (AD) and mild cognitive impairment (MCI) as it has been reported in previous studies~     based on mentally stimulating activities analysis.~      The hypothesis is that a complex cognitive training alters the neural networks in both~     subject groups and this alteration is associated with improvement or stabilization of~     cognitive and non-cognitive function.~      The investigator will perform a complex cognitive training program. Twenty patients with mild~     AD and twenty four patients with MCI will be recruited in this study. The patients will be~     randomised in control- and treatment groups.Additionally indirect effects on non-cognitive~     functions will be evaluated in caregivers of the patients.~      The investigators expect that the cognitive and non-cognitive abilities will be changed~     during the cognitive training. The investigators also expect differences between treatment~     and control groups.~   "
230093|NCT00544830|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Androgens can cause the growth of~     prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or~     bicalutamide, may lessen the amount of androgens made by the body. Giving intensity-modulated~     radiation therapy together with androgen deprivation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy works~     in treating patients undergoing androgen deprivation therapy for metastatic prostate cancer.~   "
230094|NCT00544817|"~     The mechanism of action of sorafenib makes it an interesting drug to investigate in the~     treatment of patients with glioblastoma multiforme. Efficacy of agents with anti-angiogenic~     activity has already been demonstrated and the PDGF receptor target may also be pertinent in~     glioblastoma. The combination of temozolomide plus sorafenib has been investigated previously~     in the treatment of patients with advanced melanoma. The combination was generally well~     tolerated; in previously untreated patients, a standard dose of sorafenib (400mg PO bid) was~     administered with temozolomide 150mg/m2 PO daily for 5 days, repeated every 28 days (23).~      In this multicenter phase II study, patients with newly diagnosed glioblastoma will receive~     standard treatment, including initial debulking surgical resection (if feasible) followed by~     high-dose radiation therapy with concurrent temozolomide. After completion of radiation~     therapy, patients will continue treatment with temozolomide (150mg/m2 days 1-5) and sorafenib~     (400mg PO bid daily), repeated at 28-day intervals for 6 cycles.~   "
247107|NCT00318565|"~     The primary objective is to provide additional corroborative safety and efficacy data for the~     Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).~   "
230095|NCT00544804|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in~     treating patients with advanced or metastatic breast cancer that overexpresses HER2.~   "
230096|NCT00544791|"~     Recent studies have described the role of melatonin as a sleep regulator and as an anti-~     oxidative neuroprotective agent in improving sleep quality and delaying cognitive decline in~     Alzheimer's disease (AD).~      In accordance with this data, our hypothesis is that melatonin will delay the cognitive~     decline in Mild Cognitive Impairment (MCI) patients and reduce the conversion rate from MCI~     to AD.~   "
230097|NCT00544778|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and irinotecan, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Chemoprotective drugs, such as dexrazoxane, may protect normal~     cells from the side effects of chemotherapy. Giving combination chemotherapy together with~     dexrazoxane before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells~     that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with dexrazoxane followed by surgery and radiation therapy works in treating patients with~     advanced soft tissue sarcoma or recurrent bone sarcoma.~   "
230098|NCT00544765|"~     Primary objective of the study in patients without a sufficient sonographic response (i.e.~     iNC) to 2 cycles of TAC as preoperative treatment of operable (T>/= 2cm, N0-2,M0) primary~     breast cancer: To determine the response rate determined by sonography (iRR = iCR+iPR) of~     further 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of~     vinorelbine and capecitabine (NX) (TAC vs. NX)~      Primary objective of the study in patients with a sufficient sonographic response (i.e. iRR =~     iPR or iCR) to the first 2 cycles of TAC as preoperative treatment of operable (T>/=2cm,~     N0-2,M0) primary breast cancer: To determine the pCR rate of 6 cycles vs. 8 cycles of~     docetaxel, doxorubicin and cyclophosphamide (TAC x 6 vs. TAC x 8)~   "
230099|NCT00544752|"~     The purpose of this study is to test whether different indoor temperature affect the~     frequency of sleep apnea.~   "
230100|NCT00544739|"~     Cardiovascular risk in women is systematically underestimated by both - society and~     physicians. Women younger than 50 years of age with acute coronary syndrome have 2x higher~     mortality compared with age-matched men. A number of common vascular-disease-related~     conditions are more frequent in women than in men. Women develop a more severe or different~     form of vascular disease then men. Variability of onset, relative risk, and the synergy of~     traditional and novel risk factors creates a challenge to physicians possibly resulting in~     suboptimal management and disregard in women presenting with angina symptoms.~      During last 10 years the rise in coronary artery disease (CAD) prevalence in younger women is~     observed. Emerging data suggest a unique risk profile in women (hypoestrogenemia with adverse~     effects of a protracted dysmetabolic state). The risk factors assessment and the risk factors~     profiles in women that are associated with CAD may be different than in men and thus merit~     reassessment.~      Purpose The primary objective of this study is to determine characteristics and prognosis of~     women with premature coronary artery disease and to evaluate the extent of atherosclerosis~   "
230101|NCT00544726|"~     Patients suffering from pulmonary arterial hypertension (PAH) frequently remain symptomatic~     despite medical therapy. Symptoms include breathlessness, poor exercise capacity and reduced~     quality of life.~      In many other serious heart or lung diseases it has been shown that physical rehabilitation~     improves patient's fitness and quality of life. In PAH there are no clear guidelines and in~     general physical activity has traditionally been discouraged, although evidence for this~     advice is lacking. Interesting research project in Germany showed significant benefit for~     in-patient rehabilitation in PAH patients.~      In this study we will perform a controlled clinical study of out-patient rehabilitation of~     patients with PAH. We hypothesize that physical training of patients will result in increased~     exercise capacity and improved quality of life.~   "
230102|NCT00544713|"~     This study will evaluate the safety and efficacy of a new artificial tear for the treatment~     of dry eye that may occur after LASIK surgery~   "
230103|NCT00544700|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving~     bevacizumab as maintenance therapy is more effective than observation in treating patients~     with colorectal cancer.~      PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works in~     treating patients who have undergone first-line therapy for metastatic colorectal cancer.~   "
230104|NCT00544687|"~     CRx-191 is a proprietary synergistic combination drug candidate being evaluated by~     CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening~     assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor-~     alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of~     psoriasis.~   "
230105|NCT00544674|"~     RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with~     previously untreated or relapsed small cell lung cancer (SCLC).~   "
230106|NCT00544648|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Nab-paclitaxel (paclitaxel~     albumin-stabilized nanoparticle formulation) may make tumor cells more sensitive to radiation~     therapy. Giving nab-paclitaxel together with radiation therapy and carboplatin may kill more~     tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving~     nab-paclitaxel together with carboplatin and radiation therapy and to see how well it works~     in treating patients with stage III non-small-cell lung cancer that cannot be removed by~     surgery.~   "
230107|NCT00544635|"~     The goal of this project is to examine the ability of light exposure to improve the~     appearance of cutaneous scars.~   "
230108|NCT00544622|"~     Background/Aim of the study: To further reduce the 6 months stroke morbidity and mortality in~     a high volume stroke hospital and to compare the results with national and international~     data.~      Methods: 204 consecutive stroke patients are analyzed in a prospective study in a single~     center teaching institution. The intervention consists of a structured therapeutic chain of~     290 collaborating GPs, a standardised acute hospital proceeding overlapping with an early~     integrated neurovascular rehabilitation within the same institution. Primary endpoints~     include death and dependence at 6 months, secondary endpoints are the length of hospital stay~     (LOS) and the quantitative analysis of physical and psychosocial impairments. The data are~     directly compared with the same endpoints of the Swiss subgroup of the international stroke~     trial (IST).~   "
230109|NCT00544609|"~     Safety profile and to determine maximum tolerated dose of Sorafenib in combination with~     Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent~   "
230110|NCT00544596|"~     This phase I trial is studying the side effects and best dose of R-(-)-gossypol acetic acid~     when given together with cisplatin and etoposide in treating patients with advanced solid~     tumors or extensive stage small cell lung cancer. R-(-)-gossypol acetic acid may stop the~     growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as~     cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving R-(-)-gossypol acetic acid~     together with combination chemotherapy may help kill more tumor cells.~   "
230111|NCT00544583|"~     Patients undergoing primary midline laparotomy for an emergency surgical intervention with a~     suspected septic focus in the abdominal cavity.~   "
230112|NCT00544570|"~     RATIONALE: Giving high-dose chemotherapy before a peripheral blood stem cell transplant stops~     the growth of cancer cells by stopping them from dividing or by killing them. Giving~     colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the~     blood so they can be collected and stored. The stem cells are then returned to the patient to~     replace the blood-forming cells that were destroyed by high-dose chemotherapy and radiation~     therapy.~      PURPOSE: This clinical trial is studying the side effects and how well high-dose chemotherapy~     works in treating patients undergoing stem cell transplant for recurrent or refractory~     Hodgkin's lymphoma.~   "
230113|NCT00544557|"~     This study aims to provide a holistic assessment of patients receiving etanercept in a~     real-world setting.~   "
230114|NCT00544544|"~     Bipolar disorder is a common and often chronic and debilitating mental illness. The~     depressive phase of bipolar disorder contributes the largest portion of the disorder, and~     treatment resistant bipolar depression represents a significant public health problem. Recent~     research has suggested that bipolar depression is associated with elevated brain glutamate~     activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate~     activity, will lead to clinical improvement in patients with bipolar depression.~   "
230115|NCT00544531|"~     To examine the chromosomal number content in the blastomeres of embryos achieved from~     fertilization of immature oocytes at MI stage recruited following COH for IVF.~      comparison of the genetic number content of embryos and their quality in terms of cleavage~     rate and morphological score reached after fertilization of immature oocytes at MI stage~     whether arrested at the MI stage or extruded the polar body, after in vitro maturation for a~     variable length of time.~   "
230116|NCT00544518|"~     Objective--- Benfluorex may have effects on the glucose control in type 2 diabetes while it~     improves hyperlipidemia. We sought to compare the impacts of benfluorex versus metformin on~     glucose control and insulin secretion in Chinese type 2 diabetic patients.~      Research design and methods—--a 16-week, double-blind, multiple centers, random parallel~     controlled study is designed to compare the impact of benfluorex (150-450mg/day, provided by~     Shandong Xinhua Pharmaceutical Company Limited in China) on glucose control, insulin~     secretion and its safety with metformin in type 2 diabetic patients. 240 type 2 diabetic~     patients are to be recruited to receive benfluorex or metformin(1:1). HbA1c, plasma lipid~     level, insulin and glucose at 0', 30', 120' after a standard meal will be measured before and~     after treatment, while fasting and postprandial glucose measured 4 times regularly. The~     change of HbA1c from baseline to the end of treatment will taken as main efficacy criterion,~     as the changes of fasting and after standard meal glucose and insulin level and plasma lipid~     level will be taken as secondary criteria. All patient will be given safety monitor at prior~     and post treatment. Data management and statistical analysis will adopt DAS for Clinical~     Trial 2.0.~   "
230117|NCT00544505|"~     Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short~     intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery~     (peri-operatively) (POCOB) (EORTC 10902)~   "
230118|NCT00544492|"~     A. Pain and other disadvantages of AV fistula cannulation can be limited by using the~     so-called buttonhole technique.~      B. Till present in our center catheters with cylindrical points are used for cannulation of~     AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel~     point might have some advantages such as a larger entrance area and less traumatic~     cannulation. The latter may influence pain sensation of the patients.~      The above background information gives rise to the following investigational questions:~      A. Buttonhole vs rope ladder technique~        1. Is pain sensation different when using buttonhole cannulation as compared to rope ladder~          cannulation technique?~           Hypothesis:~           AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope~          ladder technique.~        2. Is the level of anxiety different when using buttonhole cannulation as compared to rope~          ladder cannulation technique?~           Hypothesis:~           AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by~          rope ladder technique.~        3. Is bleeding time different when using buttonhole cannulation as compared to rope ladder~          cannulation technique?~           Hypothesis:~           Bleeding time is shorter when using buttonhole technique versus rope ladder technique.~        4. Is the number and severity of complications related to AV fistula cannulation different~          between buttonhole and rope ladder technique?~           Hypothesis:~           When using the buttonhole technique for AV fistula cannulation the number and severity~          of complications is less than when using the rope ladder technique.~           B. Rope ladder technique using catheters with cylindrical vs. bevel point~        5. Is pain sensation different when using rope ladder cannulation catheters with~          cylindrical as compared to bevel point?~      Hypothesis:~      AV fistula cannulation using bevel point catheters causes less pain than cannulation using~     cylindrical point catheters.~   "
230119|NCT00544479|"~     Most pulmonologist request a routine chest-x-ray after bronchoscopy with transbronchial~     biopasie to exclude pneumothorax. We published a study in CHEST showing that routine~     chest-ray might not be necessary. We would like to conduct a propsective study to validate~     the results of the CHEST-study. Before and after the procedure follwing information will be~     collected: Age, Sex, Indication for procedure, number of biopsies and segment of biopsie,~     Saturation, Physical examination, Symptoms suggestive of pneumothorax. If there is no~     aggravation of the symptoms and/or physical examination after the procedure, as compared to~     before, routine chest-x-ray will NOT be done. A phone will be made 24 to 48 hours following~     the procedure to the patient.~   "
230130|NCT00544336|"~     RATIONALE: Developing a questionnaire that can be used to assess the quality of life among~     people who have a family member with cancer may help the study of cancer in the future.~      PURPOSE: This clinical trial is studying quality of life among families with a member who is~     a cancer patient.~   "
230120|NCT00544466|"~     RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT~     before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop~     the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted~     cells from a donor can make an immune response against the body's normal cells. Giving HT~     together with fludarabine phosphate and melphalan before a transplant may stop this from~     happening.~      PURPOSE: This clinical trial studies helical tomotherapy (HT), fludarabine phosphate, and~     melphalan followed by donor stem cell transplant in treating patients with hematologic~     malignancies.~   "
230121|NCT00544453|"~     The main objectives of this proposal are as follows:~      To assess the dynamic uptake and washout of 123-I MNI-308, a potential imaging biomarker for~     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in~     similarly aged Alzheimer's (AD) subjects and healthy controls~      To perform blood metabolite characterization of 123-I MNI-308 in healthy and AD subjects to~     determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-308 as a~     single photon computed tomography (SPECT) brain imaging agent~      Evaluate the test/retest reproducibility of 123-I MNI-308 and SPECT in AD subjects and~     healthy control~   "
230122|NCT00544440|"~     The purpose of this study is to investigate the effect of abiraterone acetate on levels of~     androgens and steroid metabolites in bone marrow plasma of patients with metastatic~     castration-resistant prostate cancer (CRPC).~   "
230123|NCT00544427|"~     The Optical Coherence Tomography is a minimally-invasive diagnostic tool in both the office~     and operating room settings can identify sources of airway obstruction and effective surgical~     interventions. The researcher can use Optical Coherence Tomography to image tissues of the~     aero-digestive tract during surgical endoscopy in to the nose, oral cavity, larynx and ear in~     an outpatient clinic setting.~   "
230124|NCT00544414|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving combination~     chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Drugs such as gemcitabine and cisplatin may make tumor cells more sensitive to radiation~     therapy. Giving combination chemotherapy before surgery or radiation therapy may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving chemotherapy followed by surgery,~     chemotherapy, and radiation therapy works in treating patients with locally advanced head and~     neck cancer.~   "
230125|NCT00544401|"~     Infertility is a common and distressful problem for many couples, with assisted reproductive~     techniques (ART) such as IVF and ICSI, with slightly more than 34% pregnancies per cycle.~     Acupuncture is an ancient Chinese treatment in which thin needles are inserted into various~     points along the skin, harmonizing the body's energy. Acupuncture has been found to~     increase pregnancy rates following IVF/ICSI treatments, and is believed to affect ovulation~     and fertility through elevation of beta-endorphin release and GnRH secretion, as well as~     reduced sympathetic response with increased blood flow to the uterus. The sympatho-inhibitory~     properties and impact on beta-endorphin levels of acupuncture, as well as its efficacy in~     treating depression, may be helpful in reducing stress among women undergoing fertility~     treatments as well. Hypnosis is a mind-body technique which uses suggestions during a relaxed~     state to promote healing. Hypnosis can also significantly reduce the sympathetic response,~     and is believed to produce uterine relaxation and quiescence during embryo transfer (ET),~     which may lead to a reduction in embryo displacement from the uterine cavity. No research has~     been published on the use of hypnosis with acupuncture (hypnopuncture) in ART.~      This is a pilot study to evaluate the effect of a combined regimen of hypnopuncture on~     clinical pregnancy rates in women undergoing IVF/ICSI following two failed cycles. During the~     initial pre-treatment meeting, participants who fulfill all inclusion criteria and none of~     the exclusion criteria will undergo hypnotic induction, followed by suggestions for increased~     uterine blood flow. On the day of embryo transfer, participants will be randomly divided into~     either treatment or no-treatment groups. Treatment will consist of the insertion of~     acupuncture needles into pre-determined points, to be followed by a hypnosis pre-recorded~     hypnosis session, as described above. Patients in the control group will receive standard~     care without hypnopuncture and those participants in this group who do not conceive following~     the 3rd cycle will be treated with hypnopuncture during the 4th cycle, following ET. A total~     of 100 women will be enrolled, 50 in each arm of the study.~   "
230126|NCT00544388|"~     Controlled conditions of the EEU allow a reliable assessment of the efficacy and a~     determination of the action onset, action intensity and duration of effect of levocetirizine~     and cetirizine in order to establish the relative efficacy of these two drugs available for~     the treatment of SAR.~   "
230127|NCT00544375|"~     The study quantified functional measures of red blood cell mass and oxygen in neonatal~     tissues using a non-invasive optical technique: near infrared optical spectroscopy . The~     study will determine the absolute concentrations of deoxygenated and oxygenated hemoglobin~     and calculate the tissue hemoglobin saturation and total hemoglobin concentration in viv.~     Near infrared optical spectroscopy technique use to assessing and defining tissue status in~     the anemic state and the tissue's response to transfusions, as well as in monitoring~     hemoglobin and hematocrit without pain or loss of blood.~   "
230128|NCT00544362|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and~     radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and~     cisplatin when given together with cetuximab and radiation therapy in treating patients with~     esophageal cancer that can be removed by surgery.~   "
230129|NCT00544349|"~     RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Giving more than~     one drug (combination chemotherapy) and giving them together with cetuximab may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving leucovorin together with~     fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal~     cancer and liver metastases that cannot be removed by surgery.~   "
231696|NCT00523640|"~     The purpose of this study is to find out what effects (good and bad) the combination of the~     chemotherapy drugs gemcitabine, capecitabine, and bevacizumab has on a patient and kidney~     cancer.~   "
230131|NCT00544323|"~     comparison of alveolar bone resorbtion/ changes for a period of 12 month post loading of~     different designs and brands of oral implants. in this study, a comparison between straumann~     SLA-active implants to MIS Mistral and Mistral -X implants.~   "
230132|NCT00544310|"~     The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA)~     kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing~     surgery involving the ovaries.~   "
230133|NCT00544297|"~     The purpose of this study is to examine the safety and toleration of PEP005 Topical Gel,~     administered on an actinic keratosis (AK) treatment area on the top of a hand.~   "
230134|NCT00544284|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as temozolomide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving bortezomib together with~     temozolomide may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with temozolomide in treating patients with brain tumors or other solid tumors~     that have not responded to treatment.~   "
230135|NCT00544271|"~     To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK~     Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months~     old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for~     the two DTP vaccines and single blinded for the control arm.~   "
230136|NCT00544258|"~     The purpose of this study is to determine the extent of systemic absorption of PEP005 when~     applied topically for the treatment of actinic keratoses.~   "
230137|NCT00544245|"~     This study is comparing the effectiveness of two techniques for monitoring physical activity~     and energy balance on long-term weight management (two years). The focus is on weight loss,~     prevention of weight gain, and the maintenance of a healthy weight over time. It is expected~     that both techniques will benefit long-term weight management.~   "
230138|NCT00544232|"~     The present clinical trial will investigate the efficacy of a sequential interval-shortened~     and dose-intensified preoperative use of epirubicin, paclitaxel and CMF with preoperative~     sequential administration of epirubicin and cyclophosphamide followed by paclitaxel in breast~     cancer. In addition, the influence of darbepoetin alfa on the response rate and quality of~     life is to be investigated in both treatment arms.~   "
230139|NCT00544219|"~     RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may~     help doctors predict how patients will respond to treatment.~      PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell~     lymphoma who are receiving rituximab together with cyclophosphamide, doxorubicin,~     vincristine, and prednisone.~   "
230140|NCT00544206|"~     To compare the glucose response in tube fed subjects with type 2 diabetes of a standard~     enteral product to that of a diabetes-specific enteral product~   "
230141|NCT00544193|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together~     with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when~     given together with radiation therapy in treating patients with locally advanced upper~     gastrointestinal cancer.~   "
230142|NCT00544180|"~     To determine the satisfaction of subject with Actonel 35 mg Once a Week in the treatment of~     post-menopausal osteoporosis. Open, non-controlled, multi-center study.~   "
230143|NCT00544167|"~     Sorafenib is being looked at in a number of solid tumor settings including breast cancer.~     This trial is designed as a pilot study to assess the safety and tolerability of a novel oral~     agent in combination with standard chemotherapy in the treatment of early stage node positive~     or otherwise high-risk breast cancer. If this should prove to be a tolerable regimen for~     patients, this would provide rationale for further studies in a larger randomized fashion.~   "
230144|NCT00544154|"~     The main purpose of the study was to determine the efficacy of CDP870 in treating RA~     signs/symptoms in patients who were partial responders to MTX. Other purposes were to show~     additional efficacy without increased toxicity and the immunogenic response to CDP870 during~     combined CDP870 and MTX therapy.~   "
230145|NCT00544141|"~     The purpose of this clinical study is to evaluate the performance of the COL thermometer by~     comparing its measurement to equilibrium measurement and to make a final tuning of the~     thermometer algorithm.~   "
230146|NCT00544128|"~     A non-inferiority randomized control trial in treatment naïve HIV patients to compare~     virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada~     (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir~     boosted atazanavir as key drugs.~   "
230147|NCT00544115|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell~     transplant helps stop the growth of cancer or abnormal cells. It also helps stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving tacrolimus,~     methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant~     may stop this from happening.~      PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works~     in treating patients with advanced hematologic cancer or other disorders.~   "
230166|NCT00543868|"~     This study will determine how if MK0782 is safe and tolerable and to determine how often and~     the severity of stomach and small intestine ulcers develop following administration of MK0782~     plus enteric coated aspirin, rofecoxib 25mg plus enteric coated aspirin, naproxen 500 mg puls~     enteric coated asprin vs placebo.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230167|NCT00543855|"~     The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with~     Dementia with Lewy Bodies (DLB).~   "
230148|NCT00544102|"~     This study will test the effects of insulin resistance on atherosclerosis (hardening of the~     arteries) in women who have systemic lupus erythematosus, more commonly known as lupus. Women~     with lupus have a higher chance of developing atherosclerosis than the general population,~     and as a result are more susceptible to heart attack and stroke. Insulin resistance is a~     particular risk factor for atherosclerosis, and recent small studies have shown that insulin~     resistance is more common in lupus patients than in those without lupus. The study will~     consist of a series of tests designed to assess whether there is an association between~     insulin resistance and atherosclerosis in women with lupus. This research may lead to further~     studies on possible treatments to reduce the risk of heart disease in lupus patients.~      Volunteers must be women between 30 and 55 years of age who were diagnosed with lupus within~     five or more years prior to the study. Volunteers who have kidney failure, diabetes, or~     existing atherosclerosis will be excluded from the study, as will volunteers who have had~     pulse steroid therapy within four weeks of the testing or who have been pregnant within one~     year of the testing.~      Participants will undergo the following procedures on an outpatient basis:~        -  Blood and urine tests for research purposes.~        -  Electrocardiogram (EKG) to test the general health of the heart.~        -  Oral glucose tolerance test to measure blood glucose and insulin levels. This test is~          commonly used to diagnose diabetes and pre-diabetic insulin resistance.~        -  Cardiac multidetector computed tomography (MDCT) to determine the amount of calcium~          present in coronary arteries. This test is used to diagnose atherosclerosis.~        -  Carotid artery ultrasound to show the speed of blood flow through the carotid arteries.~          This test will show abnormalities and/or blockages in the carotid arteries.~        -  Abdominal ultrasound to determine if the participant has hepatic steatosis ( fatty liver~          ), which is often found in individuals with insulin resistance and diabetes.~        -  Carotid artery magnetic resonance imaging/angiogram (MRI/MRA) to measure the thickness~          of blood vessels. This test is used to diagnose atherosclerosis.~        -  Abdominal MRI to estimate abdominal fat.~      Volunteers may be asked to participate in an MRI/MRA study to evaluate the arteries of the~     heart. This test is optional and not required by the insulin resistance/atherosclerosis~     study. The entire series of procedures will require one to three visits to complete....~   "
230149|NCT00544089|"~     To develop a biotechnological assay which will be able to recognize germ cells of the~     spermatogenic lineand and to identify the chromosomal and morphological structure of mature~     and immature male germ cells, in cases of of sperm production disorders(azoospermic~     patients).~      To recognize IL-18 in testicular tissue of azoospermic men compared to control group as it~     has been suggested that this cytokine may serve as a paracrine defense factor in the male~     gonad associated to spermatogenesis.~   "
230150|NCT00544076|"~     RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone~     prostatectomy for prostate cancer to recover from erectile dysfunction.~      PURPOSE: This randomized clinical trial is studying giving sildenafil together with~     alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical~     prostatectomy for nonmetastatic prostate cancer.~   "
230151|NCT00544063|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when~     given together with irinotecan and oxaliplatin in treating patients with metastatic cancer.~   "
230152|NCT00544050|"~     The primary purpose of this study was to document the pharmacokinetic parameters of both~     levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam~     in epileptic pediatric subjects, aged 1 month to less than 4 years.~   "
230153|NCT00544037|"~     To assess the long-term effects of early therapeutic intervention, i.e. within two years~     following a first clinical demyelinating event suggestive of MS.~   "
230154|NCT00544024|"~     The objective of this study was to determine the bioequivalence among three commercial tablet~     formulations of MQ, i.e. Lariam, Mephaquin, and Mefloquine-(AC Farma) when given in~     combination with artesunate.~   "
230155|NCT00544011|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving~     bevacizumab together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well bevacizumab given together with combination~     chemotherapy works in treating patients with metastatic colorectal cancer.~   "
230156|NCT00543998|"~     This research project designed to diagnose sinusitis using a simple and low-cost optical~     tool. Healthy sinuses are typically filled with air, and show up as bright spots on the~     camera. Infected sinuses are filled with fluid and show up dark spots on the camera. Images~     of infected sinuses could be used to diagnose sinusitis, or to check if surgical treatments~     on the sinuses have been successful.~   "
230157|NCT00543985|"~     We plan to test the hypothesis that patients with metabolic syndrome will have impaired left~     ventricular diastolic parameters. These parameters will be measured before and after a stress~     test at the end of a 3 month period of exercise training and a 10% weight loss.~   "
230158|NCT00543972|"~     The primary objective is to determine the maximum tolerated dose of AVE9633 and to~     characterize the dose limiting toxicity(ies). Secondary objectives are to determine the~     anti-leukemia activity, the global safety and the PK profile.~   "
230159|NCT00543959|"~     A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients~     with type 2 diabetes mellitus.~   "
230160|NCT00543946|"~     This is a study of GAP-134, an antiarrhythmic di-peptide. This study will provide an initial~     assessment of the safety, tolerability, and pharmacokinetics (PK) of GAP-134 after~     administration of ascending single intravenous (IV) doses to healthy Japanese male subjects.~   "
230161|NCT00543933|"~     Inhaled nitric oxide in patients with pulmonic valve insufficiency.~   "
230162|NCT00543920|"~     The study will look at the effect of MK0777on reducing anxiety in subjects with general~     anxiety disorder.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230163|NCT00543907|"~     The purpose of this study is to analyze an institution's experience with starting a~     subspecialized DIEP flap program.~   "
230164|NCT00543894|"~     Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients. A prospective,~     observational, multicenter study (ANTHICUS).~   "
230165|NCT00543881|"~     Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to~     usual care in terms of:~        -  reduction of mortality rate~        -  reduction of hospitalizations~        -  increasement of patients' quality of life~   "
230203|NCT00543374|"~     Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in~     CDAI of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of~     initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these~     cells to successfully re-induce clinical benefit.~   "
230168|NCT00543842|"~     The goal of this clinical research study is to find the highest tolerable dose of bevacizumab~     (Avastin) and erlotinib hydrochloride (Tarceva) that can be given in combination with~     standard radiation therapy and capecitabine before surgery to patients with rectal cancer.~     The safety and effectiveness of this combination of therapies will also be studied.~      The goal of this Phase I trial was to determine the maximal tolerated dose (MTD) of~     concurrent capecitabine, bevacizumab and erlotinib with preoperative radiation therapy (RT)~     for rectal cancer. The trial completed as Phase I without progressing to the Phase II~     portion.~   "
230169|NCT00543829|"~     The primary objective of this trial is to determine the rate of pathologically complete~     remissions following a preoperative dose-intensified therapy with doxorubicin and docetaxel~     with or without tamoxifen in patients with operable carcinoma of the breast. Secondary aims~     are to assess the rate of clinical complete and partial responses, of breast-conserving~     operations, and the toxicity of chemotherapy with and without tamoxifen.~      Women meeting the following criteria will be eligible for the study: operable breast cancer~     (T³3cm N0-2 M0), histologically confirmed diagnosis by core-cut needle or incisional biopsy,~     and measurable disease by mammography or sonography or breast MRI (best appropriate method~     has to chosen by investigator). After the patients have given written informed consent, they~     will be randomised to the study treatments. All patients are scheduled to receive 4 cycles of~     combination chemotherapy consisting of doxorubicin 50 mg/m² (15-min i.v. infusion) and~     docetaxel 75 mg/m² (1-h i.v. infusion). The patients allocated to group I additionally~     receive oral doses of tamoxifen 30 mg once daily, starting on the first day of chemotherapy,~     while chemotherapy alone is administered to patients of group II. Cycles should be repeated~     every 14 days, followed by surgery 8 weeks after initiation of the trial. Surgery consists of~     removal of the remaining tumour (breastconserving resection or mastectomy) and axillary~     dissection. Patients with no response or even progression of the primary tumour can be~     treated to the discretion of the investigator but should be followed up according to~     protocol. If a partial or complete tumour response has been achieved, radiotherapy is given~     to the remaining breast in patients undergoing breast conserving therapy, and tamoxifen~     treatment is continued for a further 5 years.~      Response will be assessed between the 4th cycle and surgery, using the best appropriate~     method. Clinical evaluation should be performed after each cycle. It is planned to recruite~     200 patients during a period of 1 year.~   "
230170|NCT00543816|"~     This study will look to see if MK0767 works better than placebo in controlling blood sugar in~     patients with Type 2 Diabetes who are taking insulin but do not have adequate control of~     their blood sugar.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230171|NCT00543803|"~     This observational study is supposed to assess (under conditions of clinical practice in~     daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada~     (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection~     or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved~     under previous anti-retroviral combination therapy after switch to combination treatment of~     Viramune (nevirapine) and Truvada (tenofovir and emtricitabine).~   "
230172|NCT00543790|"~     This is the first multiple-dose study in humans with PRA-027. This study will provide an~     assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed,~     metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is~     active in the body) of PRA-027 after administration of 28 days of oral doses in women of~     childbearing potential (cycling) or postmenopausal women.~   "
230173|NCT00543777|"~     The goal of this clinical research study is to test the accuracy of magnetic resonance~     elastogram (MRE) and 2-point dixon magnetic resonance imaging (2PD MRI) using new computer~     software (called phase correction algorithm) in patients who might have liver disease.~   "
230174|NCT00543764|"~     Efficiency in the operating room can be difficult in long cases with multiple surgeons. We~     used a team based approach to develop an intraoperative pathway for microsurgical breast~     reconstruction with a deep inferior epigastric perforator flap.~   "
230175|NCT00543751|"~     The purpose of this study is to compare how MK0767 and metformin and sulfonylurea therapy~     lower blood glucose in patients with inadequate glycemic control This is an early phase trial~     and some specific protocol information is in progress and not publicly available at this~     time. (Full information is available to trial participants).~   "
230176|NCT00543738|"~     A study to test the effects of MK0767 when added to Metformin in patients with inadequately~     controlled Type 2 Diabetes Mellitus.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230177|NCT00543725|"~     The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278~     given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily,~     when combined with a background regimen containing 2 nucleoside/nucleotide reverse~     transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1~     infected patients who have not yet taken any anti-HIV drugs. The following evaluations will~     be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution,~     relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource~     utilization and treatment adherence.~   "
230178|NCT00543712|"~     This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and~     safety of PRO95780 when given as a single agent in patients with advanced chondrosarcoma. Up~     to 90 patients with confirmed chondrosarcoma will be enrolled.~   "
230179|NCT00543686|"~     Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate~     responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in~     correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion~     of leukotrienes, response to RABA and laboratory parameters in patients with pre-school~     asthma i.e. asthma phenotypes.~   "
230180|NCT00543673|"~     To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental~     formula or a control formula~   "
230181|NCT00543660|"~     To evaluate the transplantation of a posterior corneal disc for the management of corneal~     endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet~     Stripping Automated Endothelial Keratoplasty (DSAEK).~   "
230182|NCT00543647|"~     The purpose of this study was to test the effect of fenofibrate treatment on glomerular~     filtration rate (GFR), kidney hemodynamics and tubular function in middle-aged subjects with~     normal kidney function to further investigate the increase in creatinine levels observed in~     fenofibrate-treated subjects.~   "
230183|NCT00543634|"~     The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of~     Premarin®/medroxyprogesterone (MPA).~   "
230184|NCT00543621|"~     Study to evaluate the effectiveness of a structured intervention to improve diabetes control.~   "
230185|NCT00543608|"~     The purpose of this study is to compare the clinical cure rates of two dosing regimens of~     iclaprim with vancomycin (every 12 hours [q12h]) in the treatment of patients with~     hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or~     health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive~     pathogens.~   "
230186|NCT00543595|"~     This study will test the safety and effectiveness of MK0916 in patients with Type 2 Diabetes~     Mellitus and Metabolic Syndrome.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230187|NCT00543582|"~     The first part of the study is to evaluate and determine if three different forms of MGCD0103~     (free base FB-MGCD0103, tartaric acid free base [TA-FB-MGCD0103], and dihydrobromide [2HBr]~     salt formulation MGCD0103) have the same properties when given to patients with cancer. The~     second part of the study is to determine whether MGCD0103 administered in combination with~     azacitidine is effective and safe in treating subjects with relapsed or refractory Hodgkin's~     lymphoma or non-Hodgkin's lymphoma (NHL) (follicular or diffuse large B-cell [DLBCL]).~   "
230188|NCT00543569|"~     A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.~   "
230189|NCT00543556|"~     This is a clinical trial in patients with Type 2 Diabetes to test the safety of MK0767. This~     study will also see how effective MK0767 is in lowering markers of glucose metabolism and~     improving the lipid profile and non-HDL cholesterol when compared with placebo and~     pioglitazone.~   "
230190|NCT00543543|"~     The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in~     comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered~     to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503~     reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease~     compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type~     6/11/16/18 antibodies compared with GARDASIL.~   "
230191|NCT00543530|"~     Monitor the safety and tolerability of efavirenz oral solution in combination with~     Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed~     therapy or who are intolerant to their current therapy.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230192|NCT00543517|"~     The purpose of this study is to test if MK0767 lowers blood glucose after 20 weeks compared~     to placebo.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230193|NCT00543504|"~     The goal of this clinical research study is to find the highest tolerable dose of Avastin™~     that can be given in combination with 4 other study drug/drug combinations. It will be given~     with sunitinib, with sorafenib, with a combination of erlotinib and cetuximab, and with a~     combination of trastuzumab and lapatinib. The safety and effectiveness of these drug~     combinations will also be studied.~   "
230194|NCT00543491|"~     This study will assess MK0767's ability vs. placebo to control blood glucose in patients with~     type 2 diabetes and to gauge whether fasting blood glucose is lowered, blood fats are~     improved, and insulin levels are impacted.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230195|NCT00543478|"~     Probiotics are friendly bacteria normally present in food products like yogurt whereas~     irritable bowel syndrome is a longstanding functional disorder characterized by abdominal~     pain and altered bowel habits either diarrhea or constipation dominant without a definitive~     etiology.~      Study Hypothesis:Does probiotics(Saccharomyces boulardii improves daily bowel symptoms and~     quality of life in patients with diarrhea dominant irritable bowel syndrome?~   "
230196|NCT00543465|"~     This study will look at the incidence of gastric and/or duodenal ulcers in patients with~     osteoarthritis or rheumatoid arthritis in four different treatment groups (a) MK0782 21 mg~     plus enteric-coated aspirin, (b) MK0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200~     mg plus enteric-coated aspirin, and enteric-coated aspiring alone.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230197|NCT00543452|"~     Study of the effect of oxygen on the frequency of central apnea, sleep and body temperature~     in patients with a cardiac disease~   "
230198|NCT00543439|"~     The purpose of this research study is to determine the effectiveness, safety, and~     pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are~     younger than 6 years of age, with severe or moderately severe hemophilia A.~   "
230199|NCT00543426|"~     The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic~     cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese~     medicine (TCM).~      The second purpose is according to the international clinical guideline and the specialty of~     TCM to build a standard clinical trial regulation for traditional Chinese medicine.~   "
230200|NCT00543413|"~     This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood~     pressure in patients who have hypertension (high blood pressure).~   "
230201|NCT00543400|"~     The primary objective is to evaluate the safety and feasibility of using M118 as an~     anticoagulant in the target population of subjects with stable coronary artery disease (CAD)~     undergoing percutaneous coronary intervention (PCI).~      The secondary objectives are to evaluate the effect of M118 on procedural indices including~     procedure success, abrupt closure, post-procedure TIMI flow, and catheter thrombus.~      Substudy Primary Objective The primary objective of the substudy is to characterize the~     pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary~     artery disease undergoing elective PCI.~   "
230202|NCT00543387|"~     This study will investigate the safety, side effects and how well the body tolerates MK-5108~     as well as determine different doses of MK-5108 in participants with advanced and/or~     refractory solid tumors.~   "
230204|NCT00543361|"~     The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering~     blood glucose levels in patients whose Type II diabetes is not controlled by diet and~     exercise.~   "
230205|NCT00543348|"~     The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC)~     compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas.~      2. SPECIFIC AIMS~      Study endpoints will be:~      Primary Endpoint~      1. Primary and assisted patency at 6 months~      Secondary Endpoints:~        1. Procedure effectiveness/residual stenosis~        2. Procedure-related complications~        3. Primary patency and primary assisted patency 12 months~        4. Secondary patency at 6 and 12 months~        5. Number/type of secondary interventions.~   "
230206|NCT00543335|"~     The goal of this clinical research study is to find the highest safe dose of sorafenib that~     can be given in combination with radiation therapy to people with lung cancer. The ability of~     both the study drug and radiation to control the disease will also be studied.~   "
230207|NCT00543322|"~     The purpose of this study is to quantify the brain distribution of the nicotinic receptors in~     human volunteers and their alterations in patients suffering from neurological diseases such~     as Parkinson and Alzheimer diseases and familial epilepsy. This will be done using Postron~     Emission Tomography (PET) and a new radiotracer of the nicotinic receptors.~   "
230208|NCT00543309|"~     The staged surgical pathway to treat children with single ventricle heart defects culminates~     with the Fontan operation. In this procedure, systemic venous return is rerouted directly to~     the pulmonary arteries, which serves to separate the systemic and pulmonary circulations.~     Although mortality following the Fontan operation is now uncommon, early postoperative~     morbidity including prolonged postoperative chest tube drainage and hospitalization remains~     significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory~     therapies in the perioperative period is unknown and practice varies widely between centers.~      The investigators will propose a single-center, randomized, double-blind, phase II clinical~     trial in children undergoing Fontan surgery. The investigators plan to compare the effects of~     perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical~     course and neurohumoral profile. The investigators hypothesize that, when compared to the~     milrinone and placebo groups, the nesiritide group will have more days alive and out of the~     hospital within the first 30 days after surgery.~   "
230209|NCT00543296|"~     The purpose of this study is to collect data on patients with severe uveitis that have~     required re-implantation of the sustained-release fluocinolone drug delivery device due to~     depletion of study drug in their previous implanted device.~   "
230210|NCT00543270|"~     Powerlink Bifurcated Infrarenal long-term follow-up study~   "
230211|NCT00543257|"~     Health literacy is an integral part of the pathway for the successful transfer of information~     between patients and providers. Parents of children with Attention Deficit/ Hyperactivity~     Disorder (ADHD) play an essential role in chronic care as they offer critical information to~     providers that drives appropriate education and disease management. We propose the~     development and evaluation of an electronic data entry tool that enables parents to~     communicate data essential to treatment of their children, regardless of their own literacy~     skills. The research plan addresses a question central to patient-centered information~     management: how does health literacy influence parents' report of data on ADHD and the~     process-level events that result from parent-provider communication? The following specific~     aims organize the clinical study: proposal: 1) To assess the effect of health literacy on~     successful completion of parent-reported ADHD health information in both paper-based and PCHR~     formats, and, 2): To determine the association between health literacy and process-level~     outcomes for ADHD that stem from parent-provider exchange of information. The formal~     evaluation will study a diverse cohort of parents in a randomized trial of data entry (paper~     versus PCHR) for ADHD-specific information. Primary care records for children of this cohort~     will be analyzed for the prior 12 month period. Both a retrospective examination of~     documented ADHD processes of care and a prospective evaluation of the utility of data from~     the PCHR will occur. Literacy level is a primary variable of interest throughout the~     evaluation.~   "
230212|NCT00543244|"~     Hepatitis C virus (HCV) infection is a global health problem, which may lead to chronic~     hepatitis, cirrhosis, hepatic decompensation and hepatocellular carcinoma (HCC). Recently,~     treatment with peginterferon alfa plus ribavirin has become the standard of care for patients~     with chronic hepatitis C. While genotype 2 patients can have higher sustained virologic~     response (SVR) rates to 80-90%, genotype 1 patients generally have low SVR rates of only~     40-50%. In contrast, genotype 1 Taiwanese patients have superior SVR rates than those in~     Western countries. Despite the overall improved response to this combination therapy, more~     than 75% of patients suffer from treatment-related adverse events and the costs remain high,~     which make individualized therapy of paramount importance to maximize treatment response and~     minimize adverse events.~      HCV viral kinetics with interferon-based therapies have been studied recently to evaluate~     patient responses. Early viral kinetics shown to have favorable SVR rates, which make shorter~     treatment duration possible. However, different viral kinetics were found through ethnicity.~     Recently, a pilot study to evaluate the viral kinetics of 6 Taiwanese patients with HCV~     infection who received peginterferon alfa plus ribavirin therapy has shown superior early~     viral kinetics to those in Caucasian patients. Based on the favorable SVR rates in treating~     Taiwanese patients with chronic hepatitis C, the investigators aimed to conduct a large~     confirmatory study to evaluate the viral kinetics and try to define the optimal treatment for~     these patients.~   "
230213|NCT00543231|"~     Genasense® is currently administered to subjects in clinical studies as a multiple-day~     continuous intravenous infusion. Subjects are treated on an outpatient basis and carry a pump~     that delivers the drug through a peripheral or central intravenous line. The route of~     administration limits the convenience of treatment, and catheter-related complications have~     been reported. This study is designed to evaluate the pharmacokinetics and safety of G3139~     administered by subcutaneuous injection.~   "
230214|NCT00543218|"~     Compare in postmenopausal women with established osteoporosis the effect of treatment with~     teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day~     subcutaneous on change in lumbar spine BMD.~   "
230244|NCT00542828|"~     This is a Phase II, single-arm, open-label, multinational, multicenter study of rATG in~     patients with low or intermediate-1 risk MDS who have either failed 1 prior treatment with~     growth factor(s), hypomethylating agents (5-azacitidine or decitabine), or the antiangiogenic~     agents lenalidomide or thalidomide, or who have never been treated for MDS (i.e.,~     treatment-naïve patients).~   "
230215|NCT00543205|"~     This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects~     will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic~     function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh~     classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or~     discontinued prior to completion or the rate of administration of the Genasense infusion is~     changed, the subject will be replaced.~   "
230216|NCT00543192|"~     The purpose of this study is estimate how sexual function in endometrial cancer survivors~     varies with severity of disease.~   "
230217|NCT00543179|"~     Background Somatostatin and octreotide LAR (long-acting analogue) exert a number of~     inhibitory effects: on gut hormones, but also on gastro-intestinal secretion and motility.~      Somatostatin analogues are effective in preventing symptoms and signs of both early and late~     dumping as demonstrated previously. However, octreotide LAR causes gastrointestinal side~     effects and the injection solution is difficult to prepare. Recently, a new somatostatin~     analogue with a prolonged release formulation, Lanreotide autogel (L-autogel), has become~     available. It is a viscous aqueous gel, composed solely of water and lanreotide. Deep~     subcutaneous administration may lead to increased treatment acceptance compared with~     intramuscular depot preparations. It is more easy to prepare and is though to cause less~     local side effects and technical problems than octreotide LAR. Recent studies have been done~     to measure the efficacy and safety of L-autogel in acromegalic treated previously with~     octreotide LAR. These studies showed that L-autogel is effective and well-tolerated in these~     patients, with equivalent or better disease control and less gastrointestinal adverse events.~     Until now, there is no data available on the effectivety of L-autogel in patients with a~     dumping syndrome. Therefore, this study aims to establish the effectiveness and tolerability~     of L-autogel in patients with a dumping syndrome, previously treated with octreotide LAR.~   "
230218|NCT00543166|"~     Our research contributes to the understanding of some of the basic biology of the salivary~     glands. The etiology and many of the pathomechanisms of Sjögren's syndrome are unknown. In~     particular, reasons for the female dominance, late age of onset, fatigue and the prominent~     involvement of exocrine glands are unknown. We hypothesize, due to the disease~     characteristics, that the primary target hit by the disease process is the secretory acinar~     cell and that this cell is particularly damaged in women due to insufficient support,~     normally provided by dehydroepiandrosterone and its intracrine processing.~   "
230219|NCT00543153|"~     The objectives of this study is to conduct a multicenter, dual country (United States and~     Israel), study examining the experience of patients with cancer that were considered by their~     physicians as having exceptional course of survival related to their specific disease state.~      The primary aim of the study is to develop a detailed description of patients' experience of~     an exceptional disease course. The secondary aim is to define the content domain for~     assessment and measurement of exceptional disease course in patients with cancer and identify~     lessons learned from these exceptional patients that can be a base for future studies to~     benefit others.~   "
230220|NCT00543140|"~     The purpose of the study is to evaluate the long term safety of the Swedish Adjustable~     Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to~     determine the re-operation rate (band revision, band replacement and explants resulting from~     serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.~   "
230221|NCT00543127|"~     Postmenopausal women with hormone receptor positive and negative Her2 tumours.~      Estimation of the 5-year disease-free survival in the control arm is 80%. The experimental~     arm is expected to increase the 5-year disease-free survival by 4% (up to 84%). With an alpha~     error of 0.05 and 80% power, 1445 patients per arm are needed. Assuming a 10%~     post-randomization drop-out, 3180 patients in total are needed.~      Before randomization, the patients will be stratified according to the center, positive~     nodes(0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status.~   "
230222|NCT00543114|"~     The purpose of this study is to determine the safety of lenalidomide (revlimid) in~     combination with fludarabine and rituximab and to determine the highest dose of lenalidomide~     that can safely be given in that combination. Lenalidomide is a drug that alters the immune~     system and may also interfere with the the development of tiny blood vessels that help~     support tumor growth. Lenalidomide is approved by the FDA for the treatment of two different~     blood cancers called myelodysplastic syndrome and multiple myeloma. Lenalidomide has also~     been studied in subjects with relapsed CLL. In this research study we are adding lenalidomide~     to a well-established initial therapy for CLL/SLL.~   "
230223|NCT00543101|"~     This study will evaluate patients who have achieved virologic suppression (< 400 copies/mL)~     on any dual protease inhibitor (PI) combination, to determine whether patients can substitute~     both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID)~     and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks.~   "
230224|NCT00543088|"~     Evaluating the effectiveness of atypical antipsychotics in the community - a prospective,~     multicentre, observational study to evaluate the impact on Quality of Life of GP-based~     management of antipsychotic treatment in Belgium~   "
230225|NCT00543075|"~     To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and~     moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous~     intravenous infusion for 2 days (48 hours).~   "
230226|NCT00543062|"~     To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval~     duration) at 2 dose levels compared to placebo in healthy volunteers.~   "
230243|NCT00542841|"~     Congenital adrenal hyperplasia (CAH) is a genetic disorder that affects the amount of~     steroids that the body forms. The most common form of CAH is 21-hydroxylase deficiency~     (21OHD), which leads to cortisol deficiency. This, in turn, causes the development of mature~     masculine characteristics in newborn, prepubescent, and grown females and in prepubescent~     males. 21OHD is known to be caused by the mutation of a specific gene. However, symptom~     severity among people with 21OHD varies, and adults seem to be less affected than children.~     This study will examine participants' DNA to determine what other genes may affect the~     severity of 21OHD and may make the disease milder in adults than in children.~   "
230245|NCT00542815|"~     This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in~     conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will~     allow exposure to MCI-196 for up to 52 weeks~   "
230227|NCT00543049|"~     Ovarian cancer is most often recognized in advanced clinical state, the initial therapeutic~     strategies consist of a platinum containing chemotherapy subsequent to primary surgery.~     Although initially responsive to platinum-paclitaxel containing chemotherapy, a significant~     number of patients will show tumor progression during first line chemotherapy or relapse~     within six months after completion of first line chemotherapy, therefore being characterized~     as chemotherapy resistant. Any second line chemotherapy will result in approximately 10% of~     overall response, underlining the poor prognosis for these patients with an estimated median~     overall survival of 20 weeks.~      In addition to conventional chemotherapeutics, so called small molecules are of high interest~     to establish new strategies in chemotherapy-refractory ovarian cancer (and in the long run~     first line chemotherapy). SU11248 is a polytargeting tyrosine kinase inhibitor.~      SU11248 has demonstrated clinical efficacy in kidney cancer and GIST, further clinical trials~     have been initiated in other tumor entities. Growth pattern and biological targets present in~     ovarian cancer indicate that SU11248 might be a promising compound for the treatment of~     ovarian cancer. Especially, VEGFR, PDGFR and c-kit are specific targets for SU11248, which~     are expressed in ovarian cancer. The different targets of SU11248 provide a potential~     advantage of this compound compared to single-target molecules in chemotherapy-refractory~     ovarian cancer.~   "
230228|NCT00543036|"~     Evaluation of efficacy and safety of H-coil deep transcranial magnetic stimulation 9 week~     treatment trial for cannabis addiction as assessed by measures of drug intake and craving.~   "
230229|NCT00543023|"~     To compare the effect of treatment with teriparatide with that of salmon calcitonin in~     postmenopausal women with osteoporosis.~   "
230230|NCT00543010|"~     A study to evaluate the cardiac and metabolic effects of MK0767 in patients with Type 2~     Diabetes.~      This is an early phase trial and some specific protocol information is in progress and not~     publicly available at this time. (Full information is available to trial participants).~   "
230231|NCT00542997|"~     The objective of this study is to assess the efficacy, tolerability, safety and~     pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).~   "
230232|NCT00542984|"~     To compare in postmenopausal women with established osteoporosis the effect of treatment with~     teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day~     subcutaneous on change in lumbar spine BMD.~   "
230233|NCT00542971|"~     A primary goal of this clinical research study is to find the highest safe dose of sorafenib~     that can be given in combination with idarubicin and Ara-C for the treatment of acute~     myelogenous leukemia (AML) and high-risk, myelodysplastic syndrome (MDS).~      Once the highest safe dose is found, researchers will then try to learn if this combination~     treatment can help control AML and high-risk MDS in newly diagnosed patients. The safety of~     this treatment combination will also be studied.~   "
230234|NCT00542958|"~     The purpose of this study is to determine whether NK012 is safe and effective in the~     treatment of refractory solid tumors~   "
230235|NCT00542945|"~     The primary objective of this study is to determine the efficacy of ICD therapy compared with~     control on the endpoint of death from any cause in patients with heart failure of~     non-ischemic oetiology.~   "
230236|NCT00542932|"~     Patients with COPD, suffer symptoms of breathlessness and leg weakness. Exercise programmes~     in the form of pulmonary rehabilitation (PR) have been shown to improve both of these~     symptoms significantly. PR involves patients attending a hospital or community centre. For~     some patients, leaving the house is an ordeal. This study investigated the effectiveness of~     an exercise video programme delivered in the patients home.~   "
230237|NCT00542919|"~     In this study, all patients will get investigational drug. There will be no comparator drug.~     This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and~     Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes:~        -  T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL)~        -  Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2)~          and marginal zone lymphoma~        -  Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and~          aggressive lymphoma with prior clinical history of indolent lymphoma.~   "
230238|NCT00542906|"~     The implication of the second somatosensory area (SII) and the insular cortex in the~     processing of somatosensory inputs is now well established. However the functional anatomy of~     these areas hidden in the depth of the sylvian scissure remain mostly unknown.~      The aim of this fMRI study is to determine the functional cartography of SII and insula. The~     localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat~     pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.~   "
230239|NCT00542893|"~     This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics~     of dacarbazine(DTIC) when administered in combination with Genasense~   "
230240|NCT00542880|"~     This study is to assess the effects with two different inhaled respiratory medications with~     regards to improvement of lung function, symptoms and morning activities.~   "
230241|NCT00542867|"~     The survey try to establish the proportion of patients on lipid-lowering pharmacological~     treatment reaching the LDL-C goals according to the Third Joint European Task Force~     guidelines, overall and by country.·~   "
230242|NCT00542854|"~     Unlike phones, which are commonly held to the ear, music is now available via portable MP3~     players and they can be held almost anywhere. Thaker et al state that Apple iPods cause~     pacemaker interference in 50% of their patients, with over-sensing in 20% of patients,~     telemetry interference in 29% of patients and pacemaker inhibition in 1.2% of patients. The~     mean age for their sample was 76.1 years +/- 8.6 years. We anticipate that a higher~     proportion of teenagers and children who have pacemakers use portable MP3 players than in the~     elderly adult population.We will include the first 100 patients with pacemakers and ICDs who~     consent for the prospective observational study a single tertiary care center. We intend to~     conduct a descriptive study, tabulating the number of times that a pacemaker or ICD has~     changes in the sensing thresholds, pacing thresholds, telemetry interference or pacemaker~     inhibition when exposed to a series of portable MP3 players at various distances. In~     addition, we will describe the nature and quantitative differences of those changes.~   "
232365|NCT00514774|"~     The purpose of this study is to evaluate the safety of the drug ursodiol (ursodeoxycholic~     acid, UDCA) in people with Huntington's disease (HD) and to explore how the compound is~     processed by the body.~   "
230246|NCT00542802|"~     The principal purpose of the study is to determine the efficacy and safety of Levetiracetam~     versus Carbamazepine, intended as the number of patients free from crisis during the whole~     period of treatment, in patients affected by post stroke late onset crisis.~   "
230247|NCT00542789|"~     The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus~     placebo once daily for up to 24 weeks of treatment involving patients with a history of~     gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID)~     therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the~     treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal~     ulcers~   "
230248|NCT00542776|"~     The purpose of this study is to compare the efficacy and safety of influenza vaccine in~     patients with inflammatory bowel disease (IBD) on immunosuppressive therapy with IBD patients~     on aminosalicylates and healthy historical controls.~   "
230249|NCT00542763|"~     Primary Sjogren's syndrome (pSS) is an autoimmune disorder characterized by~     keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations~     may develop. Several immunomodulating agents have been attempted in the treatment of pSS~     without achieving satisfactory results. Currently, there is no approved systemic treatment~     for pSS.~      Mycophenolic acid (MPA) is a selective inhibitor of inosine-monophosphate-dehydrogenase which~     leads to inhibition of the de novo pathway of nucleotide synthesis. The antiproliferative~     effect of MPA mainly affects activated T- and B-lymphocytes because the proliferation of~     these cells is critically dependent on the de novo purine synthesis compared to other~     eukaryotic cells. Since these lymphocytes have been suggested to play a pivotal role in the~     inflammation and immunopathogenesis of pSS, mycophenolate-sodium might be a promising agent~     in the treatment of pSS.~      We perform a single-centre, open-label pilot trial with Mycophenolate sodium in pSS.~   "
230250|NCT00542750|"~     The purpose of this pilot study is to determine the feasibility of conducting a trial of~     N-Acetylcysteine in cannabis dependent adolescents.~   "
230251|NCT00542737|"~     Acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is a severe lung condition~     that causes respiratory failure. Individuals with ALI/ARDS often require the use of a~     respirator or artificial breathing machine, known as a mechanical ventilator, while in an~     intensive care unit (ICU). Research has shown that lung protective ventilation (LPV), a type~     of mechanical ventilation technique, is an effective way to reduce the number of deaths due~     to ALI/ARDS. This study will evaluate the effectiveness of a Web-based educational program~     that aims to educate ICU clinicians about the use of LPV in patients with ALI/ARDS.~   "
230252|NCT00542724|"~     The purpose of this study is to demonstrate equivalent blood glucose control in patients with~     type 1 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin~     and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human~     insulin.~   "
230253|NCT00542711|"~     Curcumin is a commonly-used spice and food coloring. Evidence suggests that curcumin can~     suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The~     current available curcumin has low bioavailability restricting the effect of curcumin in~     non-colon cancer. In this study we plan to test a new liquid tumeric/curcumin extract,~     Curcumol (patent pending, Israel Patent Application No. 181,121). We predict the~     bioavailability of the liquid tumeric/curcumin extract will be better compared to the~     currently used curcumin powder.~   "
230254|NCT00542698|"~     The purpose of this study was to develop a nurse counseling intervention to increase physical~     activity behavior in people with type 2 diabetes and to improve their health~   "
230255|NCT00542685|"~     This study will evaluate the efficacy and safety of PD 0332334 for the treatment of~     generalized anxiety disorder.~   "
230256|NCT00542672|"~     Latino children in the United States have an increased risk of becoming overweight or obese.~     Previous studies have suggested that parental behaviors are an important influence on~     children's weight, but more research is needed on the types of behaviors that may contribute~     to obesity specifically among Latino children. The purpose of this study is to examine the~     connection between family eating habits and behaviors and obesity among Mexican-American~     children.~   "
230257|NCT00542659|"~     The role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b,~     MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after~     surgical Maze procedure.~      The association of expression of CTGF, TGF-b, BNP, ANP, collagen-1, and collagen-3 in LA with~     the recurrence of AF after surgical Maze procedure.~   "
230258|NCT00542646|"~     The occurrence of Peripheral Vascular Disease has been increasing which includes the large~     artery in the upper leg called Superficial Femoral Artery (SFA). The Peritoneal Lined Stent~     has been developed as a new method for treating narrowed area in the SFA. This research study~     will determine the safety and effectiveness of the Peritoneal Lined Stent in keeping th~     Superficial Femoral Artery open and allowing blood to flow in the leg.~   "
230259|NCT00542633|"~     The purpose of this study is to demonstrate equivalent blood glucose control in patients with~     type 2 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin~     and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human~     insulin.~   "
230260|NCT00542620|"~     This trial is conducted in Europe. The aim of the trial is to compare two methods of~     injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin~     detemir associated with insulin aspart given twice daily in either separate or mixed~     injections and to investigate if there is any clinical impact in choosing one regimen over~     another.~   "
230261|NCT00542607|"~     No information was yet available over the effect of levocetirizine in children under 12~     years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and~     safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis~     due to house dust mites.~   "
230262|NCT00542594|"~     The purpose of this survey is to describe long-term tolerance as seen under current~     conditions of use for anastrozole.~   "
230299|NCT00542100|"~     The aim of the clinical study is to evaluate the convenience and efficacy of the PCMRI in the~     assessment of the prostate in humans.~      The study cohort will include 50 patients and is designed to be non-comparative to other~     diagnostic methods.~   "
230300|NCT00542087|"~     To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment~     of osteoarthritis of the knee or hip during a six week period.~   "
230263|NCT00542581|"~     The purpose of this study is to evaluate the visual outcomes and patient satisfaction after~     implantation of a toric IOL in patients with predicted residual corneal astigmatism between~     0.75 and 1.00 D.~      Cataract is prevalent throughout the world and IOLs are routinely implanted after the~     extraction of the cataractous lens. It is the most frequently performed surgery in the United~     States with an estimated 2-3 million procedures performed annually. With the aging population~     on the rise, as well as the increasing popularity of refractive intraocular lenses, the~     number of intraocular surgeries continues to rise. Over the years, the surgical technique has~     evolved from intracapsular extraction to modern phacoemulsification. This development has~     helped with the evolution of IOLs as well. The IOLs have advanced extensively: different~     materials and designs are available, permitting implantation through smaller, sutureless~     incisions. Traditional IOLs are of monofocal design providing vision at one distance,~     typically far; and correct mainly the spherical component of the refractive error. However,~     there are patients with corneal astigmatism that require additional surgical treatment such~     as laser correction (laser in situ leratomileusis, LASIK; photorefractive keratectomy, PRK)~     or limbal relaxing incisions, RLI). Another alternative is the use of a toric IOL, which has~     been especially designed to correct both the sphere and the astigmatism. The ACRYSOF Toric~     IOL is intended for primary implantation in the capsular bag of the eye for visual correction~     of aphakia and preexisting comeal astigmatism in adult patients with or without presbyopia,~     who desire improved uncorrected distance vision, reduction of residual refractive cylinder~     and increased spectacle independence for distance vision.~      The treatment selection of the corneal astigmatism depends on the amount of cylinder as~     follows, between 0.25 and 0.75 D creating the surgical incision on the steep axis; between~     0.75 and 1.75 D, RLI; between 1 and 2.25 D, toric IOLs; and between 1 and 3.00 D, LASIK/PRK.~   "
230264|NCT00542568|"~     The purposes of this study are to assess safety, efficacy, and subject satisfaction of~     EPODURE Biopump (an autologous dermal biopump capable of sustained secretion of therapeutic~     EPO in the body, using a small tissue explant from the patient's own skin) treatment in~     Chronic Kidney Disease (CKD) patients over a period of up to six (6) months.~   "
230265|NCT00542555|"~     To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of~     signs and symptoms of Osteoarthritis.~   "
230266|NCT00542542|"~     Primary Objective:~      To determine whether the use of a paravertebral block in patients undergoing reconstructive~     surgery for breast cancer results in decreased immediate post-operative pain compared with~     patients having only general anesthesia.~      Secondary Objectives:~        1. To determine whether the use of a paravertebral block in patients undergoing~          reconstructive surgery for breast cancer results in decreased post-operative pain in the~          first 24 hours after surgery compared with patients having only general anesthesia.~        2. To determine whether the use of a paravertebral block in patients undergoing~          reconstructive surgery for breast cancer results in decreased post-operative nausea and~          vomiting in the first 24 hours as compared with patients having only general anesthesia.~        3. To determine whether the use of a paravertebral block in patients undergoing~          reconstructive surgery for breast cancer results in a decreased length of hospital stay~          compared with patients having only general anesthesia.~   "
230267|NCT00542529|"~     This study is a randomized, placebo-controlled, dose-escalation, single-center study~     evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of~     66 subjects will be enrolled into 2 cohorts and, within each cohort, randomized to 1 of 7~     treatment groups receiving Imprime PGG or placebo in varied dosing regimens with~     granulocyte-colony stimulating factor (G-CSF).~   "
230268|NCT00542516|"~     Currently the most use solution to volemic reposition in hip replacement arthroplasty is the~     crystalloid solution. This trial intends to compare two different volemic replacements: HES~     and Ringer's lactate. This research has been analyzing hemodynamic parameters and the~     coagulation status before and after the pre-expansion with the solutions above mentioned.~   "
230269|NCT00542503|"~     Flash pulmonary edema is a sudden, abnormal build-up of fluid in the lungs. It is usually~     caused by heart failure and can be life threatening. The purpose of this study is to~     determine if a new form of magnetic resonance imaging (MRI) can identify abnormal blood flow~     to the lungs and predict increased risk of developing flash pulmonary edema among older~     adults.~   "
230270|NCT00542490|"~     The purpose of this study is to determine the progression-free survival of patients with~     surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with~     high-intermediate risk factors treated by vaginal cuff brachytherapy followed by~     chemotherapy.~   "
230271|NCT00542464|"~     The study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple-dose (7 day),~     dose-escalation study assessing the safety, pharmacodynamics, and pharmacokinetics of~     intravenous Imprime PGG™ Injection in healthy adult subjects.~   "
230272|NCT00542451|"~     The purpose of this study is to find out what effect the postoperative combination of~     therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer~     recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node~     positive and high risk node negative disease. This tests utilizes a well tolerated regimen of~     weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2~     positive. We would like to determine how effective this drug combination is when used in~     women with early stage breast cancer, as well as to better define the side effects of this~     treatment.~   "
230273|NCT00542438|"~     The specific aim of this study is to collect preliminary data on the feasibility and validity~     of home-based data collection methods to measure four constructs:~        -  Physical Activity: Real-time assessment using Ecological Momentary Assessment (EMA) and~          pedometers~        -  Cardiorespiratory Fitness: Step test~        -  Anthropometry: Waist and hip circumference measurements~        -  Environmental Variables: Examples include density of neighborhood physical activity~          facilities (including gyms, parks, walking trails), crime, land use mix, and~          transportation variables, collected by participants using EMA.~   "
230274|NCT00542425|"~     The purpose of this study is to determine whether BA058 is effective in building bone in~     postmenopausal women with osteoporosis.~   "
230275|NCT00542412|"~     Evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of~     riluzole-treated subjects who experienced death, permanently assisted ventilation (PAV) or~     tracheostomy, to a group of recent historical controls for the treatment of amyotrophic~     lateral sclerosis (ALS).~   "
230301|NCT00542074|"~     Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62%~     ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for~     preventing BV recurrence after treatment.~   "
230302|NCT00542061|"~     The purpose of this study is to determine the clinical effectiveness and cost-effectiveness~     of a written expert advice for GPs on additional diagnostic, treatment, and referral of~     patients based on half-yearly monitoring routines for patients with COPD or ashtma with a~     persistent obstruction in primary care based on a multicentre randomised nested clinical~     trial~   "
230276|NCT00542399|"~     An open-label, treat to target, intervention study in order to compare the metabolic control~     of once to twice-daily insulin Detemir injections in children and adolescence with type 1~     diabetes mellitus.~      All eligible patients will be assigned to receive insulin Detemir once daily before~     breakfast. Short acting insulin analog, Novorapid, will be used for mealtime insulin. The~     starting dose of insulin Detemir will be individually determined.Based on self-measured~     fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at~     pre-breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and~     80-130 mg/dl for subjects aged 13-18 years.Patients that after 4 weeks titration phase will~     not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due~     to hypoglycemic episodes would be switched to treatment consist of twice daily insulin~     Detemir. If the target blood glucose are not achieved at the end of the 4 weeks titration~     phase, but further up titration is possible and patient does not suffer from hypoglycemic~     episodes, the titration period would be extended and patient would not be switched to~     treatment with 2 injections of insulin Detemir.When achieving blood glucose targets patient~     will continue until study end on the maintenance phase.~   "
230277|NCT00542386|"~     This is a phase III multi-centre study in two periods: the first period is a phosphate binder~     and lipid lowering drugs washout for 8 weeks, the second period is a double-blind,~     randomised, parallel group, fixed dose, for 12 weeks.~   "
230278|NCT00542373|"~     The goal of this clinical research study is to evaluate fluorescence imaging, widefield~     fluorescence imaging, point spectroscopy imaging methods, and or/ oral brush cytology that~     may help doctors monitor patients at an increased risk of developing an oral cancer,~     including those with pre-cancerous lesions in the mouth.~   "
230279|NCT00542360|"~     This cluster randomized trial will test whether a social marketing program implemented in~     churches can motivate older adults to join exercise classes, in order to improve their~     strength and balance and thus prevent falls.~   "
230280|NCT00542347|"~     Proton pump inhibitors (PPI) are used to decrease stomach acid secretion. A generic form of~     omeprazole, one of the PPIs, is on the market. With cheaper than brand name PPIs, it is~     unclear whether generic omeprazole is as effective clinically. This study compares generic~     omeprazole with half-dose esomeprazole, the strongest brand name PPI. The half-dose~     esomeprazole is in fact cheaper than generic omeprazole. Healthy volunteers will take each~     medication in turn for 7 days and their stomach acid will be measured while taking each~     medication. We hypothesize that half-dose esomeprazole is better at suppressing stomach acid~     than generic omeprazole.~   "
230281|NCT00542334|"~     This study will help determine the frequency and magnitude of nocturnal hypoglycemia (low~     blood sugar at night during sleep), in children with type 1 diabetes who are on a standard~     insulin regimen, by using a Continuous Glucose Monitoring System (CGMS). Secondary objectives~     include the establishment of a definition of nocturnal hypoglycemia for the CGMS and for the~     calculation of sample size needed for future studies using CGMS. Nocturnal hypoglycemia (NH)~     can be associated with significant morbidity including seizure and coma. The investigators~     intend to use the CGMS in a future study investigating the use of a new insulin combination~     aimed to decrease the frequency of NH in the pediatric population.~      Thirty pediatric subjects with established type 1 diabetes mellitus will be asked to wear a~     CGMS for 3 days. During this time the participants will be required to test and record~     self-monitored blood glucose readings at designated time periods and if they have symptoms of~     hypoglycemia. The comparison of these values with each other and with different previously~     defined values of NH will allow for a clear definition of NH to be made. A survey has also~     been designed to assess participant satisfaction with the CGMS.~   "
230282|NCT00542321|"~     Intensive care unit (ICU) patients on respirators are at high risk for preventable pulmonary~     complications (PPC). Turning these patients from side to side may reduce PPC, but carries the~     burden of decreases in blood pressure and oxygenation. The investigators hypothesize that~     there will be no difference in PPC or adverse events when ICU patients on respirators are~     turned by nurses or by an automated turning bed.~   "
230283|NCT00542308|"~     Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.~   "
230284|NCT00542295|"~     To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to~     the latest recommended design~   "
230285|NCT00542282|"~     Obstructive lung disease is usually a differential diagnostic consideration when a patient~     presents with breathlessness or cough. Spirometry is the key diagnostic test used to confirm~     airflow obstruction particularly in the primary care setting. Airflow obstruction that~     completely resolves after administration of a bronchodilator, by definition, excludes a~     diagnosis of COPD. Evaluation of obstructive lung disease must include pulmonary function~     testing; bronchoreversibility testing is an adjunct in differentiating between asthma and~     COPD. Bronchoreversibility cannot serve as an absolute diagnostic criterion for separating~     asthma from COPD.~      Vibration response imaging (VRI) technology provides a simple, radiation-free method to image~     the lungs, by visualizing vibration energy (lung sounds) emitted during respiration cycle. In~     this study, regional quantitative and qualitative information on vibration response is~     compared with spirometry in assessing lungs function of COPD and Asthma patients.~   "
230286|NCT00542269|"~     This proof of concept study is designed to evaluate the efficacy and safety of the~     combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of~     patients with essential hypertension and metabolic syndrome who do not respond adequately to~     amlodipine monotherapy.~   "
230296|NCT00542139|"~     This study is performed to assess the influence of intraarticular injection of 2ml Diprospan~     (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate) into~     osteoarthritic knee in patients who undergo a total knee replacement of their contralateral~     knee.~      The study population will include 50 patients with bilateral knee osteoarthritis, admitted~     for their first knee replacement surgery. Only patients with older than 50 years with primary~     osteoarthritis will be included. The patients will be randomized into 2 groups. Intervention~     group will receive an injection of 2ml Diprospan diluted in 10 ml Bupivocaine. The control~     group will receive an injection of 10ml of Bupivocaine. All patients will be followed after 6~     weeks and three functional rehabilitation and pain scores will be assessed (VAS pain score,~     Timed Up and Go Score and Functional Ambulatory Category Scale).~   "
230287|NCT00542256|"~     The purpose of this study is to determine whether a painless and noninvasive procedure called~     transcranial direct current stimulation (tDCS) combined with a method of physical therapy~     called constraint-induced movement therapy improves motor function in patients with chronic~     stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning~     tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS~     procedure sessions will be compared to sham (fake) procedure sessions, which is also called~     placebo stimulation. This study is double blind, which means neither the subjects nor~     researchers analyzing motor function will know if participants are receiving real tDCS~     stimulation or placebo. Only the person performing the procedure will know which one~     participants are receiving. Only by comparing the tDCS procedure to a sham (placebo)~     procedure can we understand if the tDCS actually improves motor function.~      We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on~     motor recovery in chronic stroke patients.~   "
230288|NCT00542243|"~     The purpose of this study is to assess whether six months of daily finasteride (PROSCAR),~     following an initial negative prostate biopsy, will improve the detection of prostate cancer~     on repeat biopsy.~      144 subjects with an initial negative prostate biopsy will be randomized to receive either~     finasteride or placebo for 6 months. The subjects will undergo a second prostate biopsy~     following drug intervention. PSA (prostate specific antigen) measurements, testosterone~     levels, and quality of life questionnaires will also be assessed during the study. The two~     groups will then be compared.~   "
230289|NCT00542230|"~     This study will collect representative blood samples from healthy children and adults and~     from children and adults who have unique red blood cell features that are related to sickle~     cell disease. Sickle cell disease is a blood disease that limits the ability of red blood~     cells to carry oxygen throughout the body. The purpose of the study is to collect a variety~     of blood samples that may then be used to investigate advances and potential new drug~     treatments for sickle cell disease.~      Volunteers must be at least 8 years of old. Samples will be taken both from healthy~     volunteers and from volunteers who have unique red blood cell features that are related to~     sickle cell disease. Candidates will be screened with a medical history.~      During the study, participants will undergo a one- to two-hour outpatient procedure at the~     National Institutes of Health Clinical Center. Once researchers have explained the study and~     obtained the participant s consent, participants will donate 8 cc (approximately 2 teaspoons)~     of blood.~      Because repeat testing helps researchers validate study findings, participants who have the~     unique red blood cell features mentioned above may also be asked if they are willing to~     return and donate another 2 cc to 8 cc of blood for additional studies. The amount of blood~     drawn will not exceed 50 ml with any eight-week period for adults or 7 cc within any six-week~     period for children.~   "
230290|NCT00542217|"~     The purpose of this trial is to the assess the safety, pharmacodynamics, and pharmacokinetics~     of escalating doses of Imprime PGG™ Injection in healthy volunteers.~   "
230291|NCT00542204|"~     Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of~     recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable~     proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in~     diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management~     (CCCM) program that actively supports a partnership between the patient and his/her~     multidisciplinary care management (CM) team using an online disease management (ODM) system,~     which is integrated with a comprehensive electronic health record (EHR) system that includes~     a personal health record and secure patient-clinician messaging capabilities. The CCCM~     program builds upon CM strategies proven effective in past studies and creates an ODM system~     that is built upon and fully integrated with a leading, commercially available EHR product -~     providing a blueprint for instituting customized, continuous care management for many~     different chronic conditions in a range of ambulatory care settings.~   "
230292|NCT00542191|"~     This neoadjuvant chemotherapy protocol focusing on triple-negative breast cancers alone~     will gather a foundation of primary tumor and axillary lymph nodal response to primary~     chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome~     data. This comparative data can then be used in building subsequent trials.~   "
230293|NCT00542178|"~     Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can~     cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes~     (ACCORD) study is examining the effect of various treatments on cardiovascular disease in~     people with diabetes. This current study will examine the effects of the ACCORD treatments on~     the progression of DR in people participating in the ACCORD study.~   "
230294|NCT00542165|"~     To collect under daily practice conditions, clinical data on the changes of sexual function~     when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with~     lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy~   "
230295|NCT00542152|"~     PHASE: IV~      TYPE OF STUDY: With direct benefit.~      DESCRIPTIVE: Multicenter, randomized, open label study.~      INCLUSION CRITERIA: Steroid-refractory ulcerative colitis.~      OBJECTIVES: To compare the efficacy of cyclosporine with infliximab in steroid- refractory~     attacks of ulcerative colitis.~      STUDY TREATMENTS:Cyclosporine 2mg/kg/day intravenous(IV)for 7days then Neoral 4mg/kg/day~     orally for 3 months. Infliximab 5mg/kg at Weeks 0, 2 and 6.~      NUMBER OF PATIENTS: 50 patients in each group i.e. a total of 100 patients.~      INCLUSION PERIOD: 24 months.~      STUDY DURATION: 27 months.~      MAIN EVALUATION CRITERIA:~      Clinical response at D7 according to the Lichtiger Index score AND Clinical Remission at D98~     according to the Mayo Disease Activity Index score~      SECONDARY EVALUATION CRITERIA:~      Clinical remission at D98 (according to the Mayo Disease Activity Index score) Endoscopic~     response Colectomy rate Tolerance~   "
230297|NCT00542126|"~     Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro~     Fertilization treatment, but may have a negative effect on uterine function and contribute~     the fact that the majority of preembryos placed in the uterus fail to implant.~      Several medical agents were shown to be beneficial when given in the luteal phase of an IVF~     cycle, but the optimal regimen has not been yet determined. In 2006, a European group~     reported that addition of GnRH analog (Decapeptyl) as luteal support in IVF cycle~     significantly improved pregnancy and delivery rates. It is not known whether this positive~     effect influences the corpus luteum, embryo or the uterus. The researchers sought to evaluate~     the effect of GnRH administration as luteal support in frozen-thaws IVF cycle.~   "
230303|NCT00542048|"~     The primary objective of study CT 4003 is to assess the behavior of EndoTAG®-1 in the body~     (making a so-called pharmacokinetic profile). Therefore, the course of the drug in the body~     is examined, i.e. the amount and speed of the drug uptake as well as the distribution and the~     elimination of the drug is being investigated. Further objectives of the study are to assess~     the effect of EndoTAG®-1 on liver metastases concerning size and blood supply measured by~     imaging techniques (contrast-enhanced ultrasound and magnetic resonance imaging as well as~     duplex sonography) and to assess the effect on blood markers which are indicators for the~     destruction and neoplasm of blood vessels (so-called markers of angiogenesis).~   "
230304|NCT00542035|"~     This is a Phase 2 study designed to test the ability of investigational study drug~     ARRY-371797 to reduce pain either perioperatively or postoperatively in a third molar~     extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects~     from the US will be enrolled in this study.~   "
230305|NCT00542022|"~     To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.~   "
230306|NCT00542009|"~     Study of whether the investigational drug CE-326,597 improves glucose control and results in~     body weight loss in patients with type 2 diabetes~   "
230307|NCT00541996|"~     The purpose of this study is to determine the absorption rate of four oral formulations of~     vabicaserin.~   "
230308|NCT00541983|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary~     efficacy of XOMA 052 in subjects with active Type 2 Diabetes Mellitus (T2D).~      IV administration of XOMA 052 is likely to improve glycemic control in subjects with T2D by~     blocking certain receptors.~   "
230309|NCT00541970|"~     Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical~     cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets~     the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all~     cervical cancers. In previous trials this vaccine has been found to be efficacious in the~     prevention of incident and persistent HPV-16/18 infections and associated cytological~     abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will~     evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and~     an alternative dosing when administered in healthy young females aged 9 to 25 years, as~     compared to the standard HPV vaccine. The Protocol Posting has been updated in order to~     comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following~     a protocol amendment.~   "
230310|NCT00541957|"~     This is a pilot study. The purpose of this study is to determine whether adding 4 months of~     behavioral therapy to primary care physician medication treatment(relative to medication~     treatment alone) improves outcomes for persistently depressed primary care patients.~   "
230311|NCT00541944|"~     The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement~     for an appropriate and riskless treatment of hyponatremia. This study try to establish an~     algorithm handling a prospective clinical categorization of hyponatremia and approving~     together the start of an appropriate symptomatic therapy.~   "
230312|NCT00541931|"~     We are seeking healthy female volunteers to determine if multinutrient supplementation~     affects visible signs of skin aging as well as blood measurements of aging. We are seeking~     smokers and non-smokers.~   "
230313|NCT00541918|"~     The aim of the study is to prove whether general anesthesia with inhaled sevoflurane reduces~     the frequency of neurological and cognitive impairment after open-heart operations with use~     of cardiopulmonary by-pass (CPB) in comparison with intravenous anesthesia with propofol.~   "
230314|NCT00541905|"~     The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as~     IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety~     profile and the duration of treatment effect of NT 201 in long-term treatment with repeated~     injection sessions.~   "
230315|NCT00541892|"~     The purpose of this study is to determine if a new medium with no human serum albumine added~     is as good as the media conventionally used for IVF/ICSI.~   "
230316|NCT00541879|"~     Type 2 diabetes and obesity in children continue to increase at alarming rates with~     devastating results. However, both these metabolic diseases are largely preventable through~     adoption of a healthy lifestyle, an understanding of what happens to food in the body, energy~     balance and some simple aspects of glucose regulation. Can elementary school children be~     taught the knowledge and skills necessary to prevent type 2 diabetes and obesity? Children~     need to learn this essential knowledge and practice these important health behavior skills.~     Elementary school may be an ideal place to master this subject that is a direct and logical~     extension of current health curricula including nutrition and physical activity blended with~     science and math.~   "
230317|NCT00541866|"~     This study will evaluate the safety and tolerability of voreloxin (vosaroxin) injection in~     combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.~   "
230318|NCT00541853|"~     This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment~     of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin~     receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal~     diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood~     pressure is not normalized by ARB alone, CCB is selected additionally. Recent research~     suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is~     not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This~     study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is~     not controlled under 130/85 mmHg by Candesartan (ARB) alone.~   "
230334|NCT00541645|"~     Transient osteoporosis of pregnancy (TOoP) is uncommonly encountered in orthopedic and~     obstetric practice, with most reports consisting of single cases.~      This rare condition consists of significant osteoporosis affecting the hips and spine,~     causing significant morbidity, and putting young female patients at risk for vertebral and~     femoral neck fractures.~      The pathogenesis of transient osteoporosis of pregnancy is unknown, with various theories as~     to its etiology.~      Recently, a number of reports have described elevated levels of PTHrP in patients with~     transient osteoporosis in pregnancy and of the postpartum period Our goal in this study is to~     assess the role of PTHrP in transient osteoporosis of pregnancy~   "
230319|NCT00541840|"~     Soft tissue sarcomas (STS) are an uncommon group of malignant tumors of mesenchymal origin.~     For most advanced STS types, chemotherapy is currently the only available treatment.~     Unfortunately, a very limited number of useful drugs are active against this disease.~     Doxorubicin is widely considered the standard first-line treatment. Ifosfamide has also a~     well-established activity (1,2) and is often administered either associated with Doxorubicin~     or alone as a second-line chemotherapy treatment. Other drugs such as DTIC, Gemcitabine and~     Temozolomide showed modest activity as a second-line agents (3,4). Thus, there is a necessity~     to identify new agents with activity to improve therapy for patients with advanced STS. In~     some studies, most STS showed VEGF expression, and elevated serum VEGF levels were found to~     correlate with higher histologic tumor grade (5,6). Additionally, inhibition of VEGFR was~     associated with tumor activity in preclinical models of sarcoma (7,8). For these reasons,~     inhibition of VEGFR seems to be a reasonable approach to explore in the treatment of STS.~     Sorafenib (BAY 43-9006) is an orally available, small molecule multi-kinase inhibitor of~     VEGFR, PDGFR and RAF with demonstrated activity in the treatment of renal cell cancer (9).~     Preclinical studies suggest that the combination of Sorafenib with cytotoxic agents results~     in additive anti-tumor activity (10), initiating justification for combination studies. A~     recent trial, however, reported an unexpected incidence of cardiac toxicity in patients with~     STS treated with Bevacizumab, a monoclonal antibody that binds VEGF, in combination with~     Doxorubicin (11). This finding suggest that the possibility of potentiation of the~     cardiotoxicity of Doxorubicin when inhibiting the VEGF pathway cannot be ruled out. The~     association of Sorafenib with Ifosfamide, the other established active agent against STS,~     could improve the efficacy of single-agent Ifosfamide minimizing the risk of cardiac toxicity~     .~   "
230320|NCT00541827|"~     The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both~     skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted~     patients. Secondary aims are to clarify the pathogenesis and the clinical relevance of~     mitochondrial damage during sepsis.~   "
230321|NCT00541814|"~     The purpose of this trial is to ascertain whether the withdrawal of calcineurin inhibitors~     (CNI) will lead to less kidney transplant damage when compared with minimisation. The~     investigators will assess this by comparing the degree of damage on kidney biopsies taken~     before and after minimisation/withdrawal of CNI.~   "
230322|NCT00541801|"~     In this study, the investigators sought to determine whether an acoustic cardiographic~     assessment of heart function is equivalent to Doppler-echocardiography in patients who are~     treated with cardio-toxic cytostatic agents.~   "
230323|NCT00541788|"~     The purpose of this clinical phase I study is to measure the efficacy and side effects of~     Common Sage in the treatment of hot flashes in 10 patients with prostate cancer who receive~     androgen deprivation (AD) (exclusively or as part of a multimodality treatment) for a period~     of minimum 6 months. Concomitant use of a non-steroidal anti-androgen during the first month~     of the AD is permitted to prevent the flair-up phenomenon. However, the inclusion of patients~     in the study will only start at least 2 weeks after the cessation of the anti-androgen. This~     is done to exclude a possible influence of the anti-androgen on the severity and frequency of~     hot flashes.~      Once the informed consent is signed, the patient receives the study diary to note the daily~     frequency and severity of hot flashes and their effect on daily quality of life. The severity~     of the hot flashes is measured by the Moyad scoring scale. The effect on daily quality of~     life is measured using the Hot Flash Related Daily Interference Scale (HFRDIS). The patient~     will be instructed in detail how to use the diary.~      After week 1, the patient returns the diary to the responsible physician. In return the~     patient receives the study medication (Common Sage, product) and a diary for the next week~     (=week 2). This procedure will be repeated until the end of the observation period (2 months~     after enrollment in the study). The common Sage will be provided in tablets. The suggested~     dose of Common Sage is 3 tablets a day (morning - noon - evening).~      To be sure that the effect of Common Sage is NOT due to an inhibition of the effect of the~     LHRH analogue, the related hormones (testosterone, FSH, LH, free testosterone and SHBG) will~     be tested at three fixed moments: day of study enrollment, 1 month after study enrollment and~     at the end of the study. In order to check the level of hemoglobin and cholesterol, every 2~     weeks a blood count will be performed. It has been shown that LHRH analogues can induce~     anemia and hypercholesterolemia. The investigators want to measure a possible effect of~     Common Sage on both.~      There are no known side-effects of the use of Common Sage. All symptoms that could be related~     to the use of Common Sage will be recorded in detail. Therefore, a clinical examination~     including blood pressure registration will be performed by the responsible physician on a~     weekly base.~   "
230324|NCT00541775|"~     The purpose of this study is to test the safety and effectiveness of sitagliptin in patients~     with type 2 diabetes.~   "
230325|NCT00541762|"~     Context: Cholecystokinin (CCK) and neurotensin are stimulated during meal intake by the~     presence of fat in the small intestine. The sequence of events suggests that fat hydrolysis~     is crucial for triggering the release.~      Objectives: The aim of this study was therefore to investigate whether CCK mediated the~     effect of intraduodenal (ID) fat on neurotensin secretion via CCK-1 receptors.~   "
230326|NCT00541749|"~     This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of~     single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in~     adults with Systemic Lupus Erythematosus.~   "
230327|NCT00541736|"~     The aim of the present study is to explore the importance of migraine genes on the~     headache/migraine responses after GTN in FHM-patients and healthy volunteers.~   "
230328|NCT00541723|"~     To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to~     placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile~     and to compare two different application schemes of Xeomin. Each subject will be treated on~     the right and left eye area, using the same dose but different application schemes (i.e. 3 or~     4 injection sites).~   "
230329|NCT00541710|"~     The purpose of this study is to determine whether the phytoestrogen genistein is effective in~     improving bone condition in pre-menopausal and post-menopausal women suffering for~     osteopenia. Since, during the study the investigators realized that at least 70% of~     post-menopausal recruited women suffered for metabolic syndrome (MS), we have added only in~     these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk.~   "
230330|NCT00541697|"~     A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus~     Atorvastatin in lowering LDL-C levels.~   "
230331|NCT00541684|"~     The study will look at the effects of losartan or atenolol on frequency of sexual intercourse~     in subjects with newly diagnosed mild to moderate hypertension.~   "
230332|NCT00541671|"~     We are doing this study to find out if extra medicine is needed to avoid the chance of nausea~     sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some~     doctors always give medicine to prevent the possible side effect of nausea, while others do~     not. We are looking to see if this extra medicine is helpful in preventing nausea. The goal~     is to screen all patients with pain and enroll enough subjects to reach our goal of 164~     evaluable study participants.~   "
230333|NCT00541658|"~     The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing~     regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.~   "
230335|NCT00541632|"~     The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA~     test system to traditional culture methods in detecting the presence of Methicillin Resistant~     Staphylococcus aureus (MRSA) directly from nasal samples.~   "
230337|NCT00541606|"~     The purpose of this study is to demonstrate that pharmacists working collaboratively with~     physicians and other providers in an ambulatory care setting can improve glucose, blood~     pressure, and lipid control, as well as improve quality of life, adherence to screening and~     general preventative measures.~   "
230338|NCT00541593|"~     Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of~     investigational surgery which uses the endoscope as the primary operative tool. The insertion~     sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra.~     Multidisciplinary teams consist of surgeons and gastroenterologists who are collaborating to~     develop safe and effective surgical techniques via the natural orifice route in order to~     avoid surgical incisions. Pancreatic pseudocysts are cavities that form typically in the~     lesser sac following an episode of acute pancreatitis, that may be able to be drained by a~     variety of techniques, including endoscopically. Chronic pseudocysts often require surgical~     drainage into the stomach. The medical device company known as Power Medical Interventions~     has a computer-powered surgical stapler which rests on a flexible shaft. Following the~     insertion of the endoscope, the powered stapler will be passed alongside the endoscope to~     help the surgeon and gastroenterologist (working as a team) to see where to properly place~     the stapler. Once the stapler is in position, one jaw of the stapler will be placed into the~     pseudocyst, and the other jaw will be left in the stomach. The stapler will then be closed~     and fired, creating a permanent connection between the two hollow spaces and allow the~     contents of the pseudocyst to drain naturally out into the stomach and intestines. Utilizing~     this technique, a surgical incision is avoided.~      Hypothesis: Patients who undergo the Natural Orifice Translumenal Endoscopic Surgery for~     treatment of their pancreatic pseudocyst will experience effective treatment with less~     discomfort and with quicker recovery than standard surgical techniques.~   "
230339|NCT00541580|"~     Triplane and Juvenile Tillaux fractures of the ankle are well known in adolescent pediatric~     population. It is widely accepted, that optimal treatment for displaced fractures is close or~     open reduction and fixation with screws under general anesthesia and under intraoperative~     fluoroscopy control. Usually a small degree of displacement (up to 2mm) is expected to be~     healed without any sequences. Until now, no evidence of ankle function and pain after~     skeletal maturity or long follow-up was published. More than that, no comparative study~     between operative and no operative treatment of mild and borderline displaced fractures were~     published.~      The purpose of this study is to evaluate functional and radiographic results of operatively~     and conservatively treated patients after they reach skeletal maturity.~   "
230340|NCT00541567|"~     This is a placebo-controlled, randomized, double-blind, parallel arm, multicenter,~     dose-ranging phase IIb trial to assess glycemic and weight loss efficacy and safety of~     BMS-646256 in overweight and obese patients with type 2 diabetes who have been treated with~     diet and exercise only or with half-maximal or greater metformin (≥1500mg/day) or~     sulfonylurea monotherapy (stable dose for at least three months), but who remained~     inadequately controlled (HbA1c >7% and HbA1c<10%).~   "
230341|NCT00541554|"~     This is a prospective, open-label study to evaluate the efficacy and safety in reducing~     antipsychotic-induced hyperprolactinemia, weight gain, and dyslipidemia by aripiprazole.~     Approximate 60 patients will be recruited to achieve at least 40 evaluable patients.~   "
230342|NCT00541541|"~     In this study, the investigators sought to determine whether a stimulation of the phrenic~     nerve affects heart function. Heart function is assessed by acoustic cardiography.~   "
230343|NCT00541515|"~     An open interventional data collection study in order to build a database to close the loop~     between glucose sensor and insulin pump.~      background: The ultimate goal in diabetes treatment is to develop an autonomous insulin~     delivery system (artificial pancreas) capable of continuous glucose sensing, thereby~     mimicking the physiologic function of the islet beta cells and freeing the patient from the~     need for constant calculations of daily insulin and carbohydrates. Several prototypes of~     closed-loop system have been developed in recent years, based on different types of control~     algorithms, to establish the connection between the sensor and the insulin pump. Current~     research in the formulation of this type of subcutaneous closed-loop system still faces major~     challenges, therefore, there is a need for further study and evaluation.~      Objectives:~        1. To evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose~          levels by using continuous glucose sensor~        2. To measure the insulin sensitivity as expressed by changes in blood glucose levels after~          s.c insulin infusion .~        3. To evaluate real time sensor calibration algorithms based on the measured lag times~        4. Collecting clinical data in order to develop and evaluate mathematical models which will~          serve a base to simulators.~        5. Developing and accessing advanced learning and control algorithms as a step towards~          developing an artificial pancreas~   "
230344|NCT00541502|"~     This is a 24-week, observational, prospective study to evaluate the effectiveness of~     improving cognitive function of aripiprazole in treating adolescents and young adults with~     psychotic disorder in Taiwan. Approximately 120 qualified patients who have clinical~     diagnosis of DSM-IV of psychotic symptom (e.g. schizophrenia or other psychotic disorders~     such as schizophreniform disorder, schizoaffective disorder, delusional disorder, shared~     psychotic disorder, bipolar disorder with psychotic feature or psychotic disorder not~     otherwise specified.) will be recruited to achieve at least 100 evaluable subjects. After~     signing the informed consent form, the demographics, medical history and concomitant~     medication will be recorded. Besides, physical examination, vital sign, BMI, DSM-IV~     multiaxial examination, CGI-S and menstrual history will be conducted. Laboratory tests and~     pregnancy test will be optionally conducted. After evaluating all variables obtained, the~     eligible patients will be enrolled into study. Patients who fulfill the inclusion / exclusion~     criteria will be performed the CPT, WCST, BPRS and WHOQOL. Afterwards, patients will be given~     their first medication at this visit (5 mg ~ 30 mg daily by subject). Besides, the switching~     period is maximum 8 weeks and is depended upon the clinical judgment of investigator.~     Efficacy will be evaluated by the change from baseline in Continuous Performance Test (CPT),~     Wisconsin Card Sorting Test (WCST), Clinical Global Impression Scale (CGI), Brief Psychiatric~     Rating Scale (BPRS) and The World Health Organization Quality of Life questionnaire (WHOQOL).~     Safety will be evaluated by the frequency of adverse events, abnormal laboratory results,~     physical examination, vital sign, BMI and menstrual history for female subgroup analysis.~   "
230347|NCT00541463|"~     A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two~     nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients~     who have not responded to or are intolerant to a non-nucleoside reverse transcriptase~     inhibitor (NNRTI) containing treatment.~   "
230348|NCT00541450|"~     The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A~     in comparison to a commonly used medication in patients with type 2 diabetes.~   "
230349|NCT00541437|"~     To evaluate the efficacy and safety of type 2 diabetes patients switched from sulfonylurea~     co-administered with metformin to glyburide/metformin combination tablet. It is expected that~     safety and efficacy of GlucoMet® is not inferior to co-administration of sulfonylurea and~     metformin.~   "
230350|NCT00541424|"~     The goal of this clinical research study is to learn if positron emission tomography~     (PET)/computed tomography (CT) scanning can be used to detect mantle cell lymphoma in the~     colon. Researchers want to learn if PET/CT scanning can produce good-quality images and/or~     find the exact locations of lymphoma in the body.~      Primary Objective is to determine if combined CT colonography and full body PET scan is~     technically feasible and can produce diagnostic scans as well as accurate anatomic~     coordination for detection of mantle cell lymphoma involvement of the colon.~   "
230351|NCT00541411|"~     Phase II Pilot Study of Vincristine, Adriamycin, Actinomycin D, Ifosfamide combination~     chemotherapy in Ewing's Sarcoma~   "
230352|NCT00541398|"~     The primary purpose of the study is to investigate whether an intensive educational~     intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the~     use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related~     factors.~   "
230353|NCT00541385|"~     -  The primary objective of this clinical study is to demonstrate the efficacy of the fixed~          combination of pyronaridine artesunate granule formulation (60:20 mg; paediatric~          PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate of~          more than 90%.~        -  Treatment success or failures will be classified according to WHO Guidelines 2005~   "
230354|NCT00541372|"~     For the administration of insulin, different needles are available with a length from 5 to~     12.7mm. Insulin injections with a needle of 8 mm is injected in a lifted skinfold, a 5 mm~     needle can by used without lifting a skinfold (1). In the Netherlands obese people (BMI ≥ 30)~     are usually advised to use an 8mm or even longer needle (1). Increased BMI and the thickness~     of the subcutaneous tissue slow insulin absorption (2, 3, 4), possibly related to reduced~     subcutaneous blood flow. Furthermore, the capillaries are located just under the skin and~     between the fat and muscle layer. This could possibly determine the absorbing speed (2). It~     is not know if the administration of insulin with a 5mm needle by obese people has a~     different influence on the HbA1c compared to longer needles. The hypothesis of this study is~     that for the purpose of insulin injections, a 5 mm needle can be used without negative~     effects on metabolic parameters in patients with Diabetes Mellitus (DM) and a Body Mass Index~     (BMI) ≥ 30.~   "
230355|NCT00541359|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving bortezomib together~     with topotecan hydrochloride may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan~     hydrochloride when given together with bortezomib in treating patients with advanced solid~     tumors.~   "
230356|NCT00541346|"~     This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system)~     for the treatment of attention and behavioral symptoms in children with Autism Spectrum~     Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total~     of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism~     spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal~     route of administration in this population will also be assessed.~      The researchers hypothesize that Daytrana is a safe and effective medication for children~     with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and~     impulsivity.~   "
230357|NCT00541333|"~     The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as~     preventive therapy of the immunomodulatory substance named copaxone which had been proven as~     safe and effective agent for a neurodegenerative disease, in arresting the progression as~     well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent~     copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may~     open a new avenue of preventive treatment for the disease which is the major cause of legal~     blindness in the industrial world~   "
230358|NCT00541320|"~     This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of~     VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s)~     and dose regimen of GW813893 for future investigation.~   "
230359|NCT00541307|"~     The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin~     Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device~     patency at 12 months is the primary endpoint.~   "
230360|NCT00541294|"~     Background: The TB and HIV epidemics are closely linked in developing countries, where~     450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children~     and is reversing gains made in child survival.~      The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB~     infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker,~     more accurate way to diagnose TB infection. Such diagnostic testing may directly guide~     clinical management and preventive strategies in immune-suppressed HIV-infected children, who~     are at high risk of becoming TB diseased following infection. Data regarding the usefulness~     of these tests in children is currently limited.~      Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic~     testing can accurately identify children with TB infection. In a community with high rates of~     TB and HIV infection, the following specific aims will be investigated in HIV-infected and~     uninfected children:~        1. assess the agreement between the TST and blood-based diagnostic testing,~        2. compare the performance of the TST and blood-based diagnostic testing to a standardized~          history of TB exposure,~        3. measure the impact of age, nutritional and immune status on children's response to~          blood-based testing,~        4. describe factors that might modify children's response to testing over time, and 5)~          examine the effect of environmental exposures and previous vaccination on the TST,~          blood-based testing and other measures of immune responses to TB.~      Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in~     children include 1) timely institution of treatment for TB infection to prevent severe~     disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of~     childhood TB infection also prevents future contagious adult disease, thus decreasing~     community transmission. Blood-based diagnostic testing may also be able to identify children~     that are more likely to become ill following TB infection. Therefore, blood-based diagnostic~     testing has great potential to improve TB control and the health of HIV-infected and~     uninfected children, their households and communities.~   "
230361|NCT00541281|"~     we propose to randomize patients with hormone resistant prostate cancer between~     docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal~     endpoint will be the efficacy in term of PSA response.~   "
230362|NCT00541268|"~     Primary objective: The primary objective of this study is to determine the efficacy of ICD~     therapy compared with control on the endpoint of death from any cause.~      Secondary objective: The secondary objectives of the study are to determine if ICD therapy~     reduces sudden death.~      Study design: Randomized, unblinded, controlled, parallel two group trial.~      Primary endpoint: Time to death from any cause.~      Sample size: In total, 1000 patients with 500 receiving ICD and 500 patients constituting the~     control group.~      Summary of Subject Eligibility Criteria: Patients with clinical heart failure, left~     ventricular ejection fraction (LVEF) ≤ 35%, non-ischemic etiology and NT-proBNP above 200~     pg/ml. Patients in NYHA class IV will only be randomised if also fulfilling criteria for a~     biventricular pacemaker.~      Control group: Patients receiving standard therapy for heart failure including~     ACE-inhibitor/Angiotensin-Receptor-Blocker and Betablocker unless not tolerated. Aldosterone~     antagonism is optional.~      Study Duration: The study comprises a screening period of up to 2 years, followed by a~     treatment phase of a minimum of 36 months.~      Randomisation: After fulfilling all eligibility criteria, subjects will be randomized 1:1 to~     receive ICD implantation or continue usual control. Randomisation will be stratified~     according to treatment with a biventricular pacemaker.~      Treatment: After randomisation patients allocated to ICD treatment should receive this as~     fast as possible and preferably within 2 weeks (latest 4 weeks). The ICD will be programmed~     with anti-tachycardia pacing and shock therapy.~      Assessments: Deaths and hospitalisations for heart failure, stroke or arrhythmias will be~     recorded throughout the study duration.~      Statistical Considerations: Median lifetime in the control group is expected to be 5 years. A~     p-value of 5% (2-sided) is required for significance together with a power of at least 80%.~     With a relative risk reduction of 25% a sample size of 812 patients in total is required. In~     order to allow for cross-over a sample size of 1000 is planned.~      Primary Endpoint Analysis: The principal analysis for the primary endpoint (time to death~     from any cause) will employ the intent-to-treat principle and use a survival analysis.~      Secondary Endpoint Analysis: All time-to-event secondary endpoints will be analyzed similarly~     to the primary endpoint.~   "
230363|NCT00541255|"~     Asthma is a common disease that is often diagnosed in childhood. In some teenagers, asthma~     symptoms disappear and treatment can be stopped; however, for some of these people, asthma~     symptoms return in adulthood. This study will examine data collected over the lifetime of~     18-year olds to identify factors that may increase a person's chance of having recurrent~     asthma as an adult.~   "
230364|NCT00541242|"~     The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients~     with glaucoma or ocular hypertension~   "
230365|NCT00541229|"~     A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg~     in patients with type 2 diabetes.~   "
230366|NCT00541216|"~     Previous research has demonstrated possible efficacy of Ephedrine in the treatment of~     congenital myasthenia caused by end-plate acetylcholinesterase deficiency.~      The aim of the current study is to test the hypothesis that Ephedrine may be beneficial to~     these patients.~      To test this hypothesis we will perform a double blind, placebo-controlled, crossover study~     clinical efficacy and safety study.~      Drug naïve patients who agree to participate will be randomized to two groups. Each group~     will be treated in a blinded manner for 5 weeks with either placebo or Ephedrine HCl in an~     escalating dose up to 100 mg per day divided in two doses. After five weeks the groups will~     cross over and continue treatment or placebo for a further five weeks.~      Evaluations of strength and fatiguability will be done at baseline, at the end of each five~     week period and after a further two weeks.~      Safety will be assessed weekly by the investigators using interview and physical examination.~      Outcome measures will include Barthel index, Quality of life questionnaire, Timed up and go,~     spirometry, timed elevation of limbs, and force measurements.~      All patients will report to the clinic as per study schedule (See Appendix A). Specifically,~     the 12 clinic visits will include: baseline (1), safety and efficacy assessments(10) and~     closeout (1).~   "
230367|NCT00541203|"~     Coronary CT angiography (CCTA) offers great promise as a risk stratification tool in patients~     with suspected CAD. It has been demonstrated in a multitude of accuracy studies to have a~     negative predictive value averaging over 95%. This leads to the hypothesis that a negative~     CCTA may preclude the need for invasive testing. The purpose of this randomized controlled~     study is to prospectively evaluate the role of CCTA on the management of patients with~     inconclusive or indeterminate stress test results.CCTA is able to provide not only~     information on presence and extent of coronary artery calcification, but detailed coronary~     anatomy as well.~      SPECIFIC AIM # 1: To evaluate the diagnostic and prognostic performance of CCTA in patients~     with equivocal / intermediate stress test results as compared to conventional invasive~     coronary angiography.~      SPECIFIC AIM # 2: To evaluate the utility of CCTA in prediction of major adverse cardiac~     events (MACE) compared to invasive coronary angiography at 30 days, 1 year, 3 years and 5~     years.~   "
230368|NCT00541190|"~     The objective of this overall project is to develop a new aerosol-based technique for~     quantifying liquid absorption in the airways of subjects with cystic fibrosis(CF) that can be~     used to help develop new therapies. In CF, mutations in the CF gene result in dysfunction of~     the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) ion channel on the cells that~     line the airway epithelium, causing improper fluxes of ions such as sodium, chloride, and~     bicarbonate. The so called low volume hypothesis of CF pathogenesis contends that abnormal~     absorption of ions from the airways causes excessive absorption of liquid, resulting in an~     airway surface liquid layer that is dehydrated and difficult to clear. Here we are measuring~     the absorption rate of a radiolabeled small molecule (DTPA) from the lungs of cystic fibrosis~     patients and healthy controls. We hypothesize that the molecule will absorb more quickly in~     cystic fibrosis patients. Further studies will be performed to determine if DTPA absorption~     is related to liquid absorption in the airways.~   "
230369|NCT00541177|"~     The purpose of this study is to test the hypothesis that myopia can be prevented by using a~     low concentration of atropine eyedrops once a week.~   "
230370|NCT00541164|"~     The object of this research is to test the effectiveness of Coenzyme Q10 (CoQ10) on symptoms~     of weakness, fatigue, and pain in persons with Charcot-Marie-Tooth disease (CMT).In this~     study we also intend to examine the impact of daily supplementation on overall quality of~     life.We are also interested in identifying any differences in serum ratios of CoQ10 in the~     oxidized and reduced forms.~   "
230371|NCT00541151|"~     Multi-center, prospective, single arm study. Qualify patients will receive treatment for~     stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term~     evaluation of effectiveness and safety associated with AMS sling systems.~   "
230413|NCT00540605|"~     A new approach to HIV prevention currently being studied includes the use of topical~     microbicides, substances that kill microbes. The purpose of this study is to determine the~     levels of tenofovir, a microbicide in gel form, in HIV uninfected pregnant women who are~     expecting to deliver by cesarean.~   "
230372|NCT00541138|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Tamoxifen may help carboplatin work better by making tumor cells more sensitive to~     the drug.~      PURPOSE: This phase II trial is studying the side effects of giving carboplatin and topotecan~     together with tamoxifen and to see how well it works in treating patients with central~     nervous system metastases or recurrent brain or spinal cord tumors.~   "
230373|NCT00541125|"~     RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients~     with metastatic colorectal cancer.~      PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia~     during first-line treatment with chemotherapy and bevacizumab in patients with metastatic~     colorectal cancer.~   "
230374|NCT00541112|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy~     together with combination chemotherapy and cetuximab before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy~     and cetuximab after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II clinical trial is studying how well giving radiation therapy together~     with chemotherapy and cetuximab followed by surgery, chemotherapy, and cetuximab works in~     treating patients with locally advanced or metastatic rectal cancer that can be removed by~     surgery.~   "
230375|NCT00541099|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such~     as docetaxel, also work in different ways to kill tumor cells or stop them from growing.~     Giving bevacizumab together with docetaxel may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel~     works in treating older patients with stage III or stage IV non-small cell lung cancer.~   "
230376|NCT00541086|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking use of estrogen by the tumor cells.~     Anastrozole, letrozole, and exemestane may fight breast cancer by lowering the amount of~     estrogen the body makes. It is not yet known whether giving tamoxifen followed by~     anastrozole, letrozole, or exemestane is more effective than giving anastrozole, letrozole,~     or exemestane alone in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying giving tamoxifen followed by either~     anastrozole, letrozole, or exemestane to see how well it works compared to anastrozole,~     letrozole, or exemestane alone in treating postmenopausal women with hormone-responsive~     invasive breast cancer that has been completely removed by surgery.~   "
230377|NCT00541073|"~     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving pemetrexed together with cisplatin and vitamin B12 may kill more tumor~     cells.~      PURPOSE: This phase II clinical trial is studying how well giving pemetrexed together with~     cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that~     cannot be removed by surgery.~   "
230378|NCT00541060|"~     Alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for~     a matrix protein could increase the susceptibility of the enamel to caries after tooth~     eruption. To identify in young patients with severe caries incidence, the occurrence of~     mutations in several candidate genes which result in an alteration of the enamel~     microstructure that could explain the high caries susceptibility of the patient.~   "
230379|NCT00541047|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause~     the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin,~     leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving~     radiation therapy together with androgen deprivation therapy may kill more prostate cancer~     cells.~      PURPOSE: This randomized phase III trial is studying how well giving radiation therapy~     together with androgen deprivation therapy works in treating patients who have undergone~     surgery for prostate cancer.~   "
230380|NCT00541034|"~     RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Giving pentostatin~     together with cyclophosphamide and rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving pentostatin~     together with cyclophosphamide and rituximab works in treating patients with previously~     untreated chronic lymphocytic leukemia.~   "
230381|NCT00541021|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. It is not yet known whether giving~     gemcitabine together with sorafenib is more effective than giving gemcitabine alone in~     treating pancreatic cancer.~      PURPOSE: This randomized phase III trial is studying giving gemcitabine together with~     sorafenib to see how well it works compared with giving gemcitabine alone in treating~     patients with locally advanced or metastatic pancreatic cancer.~   "
230382|NCT00541008|"~     RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in~     treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.~   "
230383|NCT00540995|"~     RATIONALE: Giving chemotherapy drugs, such as busulfan and etoposide, and intensity-modulated~     radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells.~     It also helps stop the patient's immune system from rejecting the donor's stem cells. When~     the healthy stem cells from a donor are infused into the patient they may help the patient's~     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving intensity-modulated radiation therapy together with busulfan and etoposide before a~     transplant may stop this from happening.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of~     intensity-modulated radiation therapy when given together with busulfan and etoposide~     followed by a donor stem cell transplant and to see how well it works in treating patients~     with advanced myeloid cancer.~   "
230384|NCT00540982|"~     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This pilot trial is studying the side effects and best dose of vinorelbine in~     treating patients with advanced solid tumors that have not responded to treatment and liver~     dysfunction.~   "
230385|NCT00540969|"~     RATIONALE: Cryoablation kills cancer cells by freezing them. Radiation therapy uses~     high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known~     whether cryoablation is more effective than external-beam radiation therapy in treating~     painful bone metastases.~      PURPOSE: This randomized phase III clinical trial is studying cryoablation to see how well it~     works compared with external-beam radiation therapy in treating patients with painful bone~     metastases.~   "
230386|NCT00540956|"~     RATIONALE: Studying natural killer cells in samples of blood from patients with cancer may~     help doctors find out how these cells are effected by chemotherapy.~      PURPOSE: This clinical trial is studying natural killer cells in older patients with acute~     myeloid leukemia.~   "
230387|NCT00540943|"~     Subjects will be entered into cohorts of 3 for the dose escalation phase so that the maximum~     tolerated dose can be determined. 18 additional patients will be recruited once the maximum~     tolerated dose (MTD) is determined for disease assessment.~   "
230388|NCT00540930|"~     Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving~     treatments can deliver equivalent life prognosis in the management of small and medium sized~     uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most~     common eye-preserving treatment in the current management of uveal melanoma, but is~     complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies~     for the prevention and early treatment of radiation retinopathy/maculopathy need to be~     developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is~     the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits~     the activity of vascular endothelial growth factor A, a mediator in the development of~     choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as~     age related macular degeneration. This study will investigate the possible benefit of~     Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following~     plaque radiation for uveal melanoma.~   "
230389|NCT00540917|"~     Lasers are the treatment modality of choice for Port Wine Stain birthmarks.The epidermis is~     not totally spared due to partial absorption of energy therein by melanin that presents an~     optical barrier through which the light must pass to reach the underlying blood vessels.~     Absorption of laser energy by melanin causes localized heating in the epidermis, which may,~     if not controlled, produce permanent complications such as hypertrophic scarring or~     dyspigmentation.~   "
230390|NCT00540904|"~     Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A~     study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in~     comparison with the same volume hydratation with sodium bicarbonate. The investigators will~     try following the original protocol making 2 randomized groups of patients, with cancer~     diagnosis, >18 years old, with a GFR <60 and >30 ml/min/1,73m2 by MDRD formula and/or~     diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a~     sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during~     and 6 hours before the injection. The primary end point will be the rise of 25% or more in~     creatinine or dialysis needed.~   "
230391|NCT00540891|"~     Primary: Evaluate the safety and onset of symptom relief using an acute I-PSS form (7 day~     form).~      Determine onset of urinary peak flow improvement after 7 days Secondary: Determine~     improvement in Bother Score after 7 & 28 days; improvement in sexual function after 28 days;~     assess one-month efficacy and safety~   "
230392|NCT00540878|"~     This study will examine the effects of formulation on the relative bioavailability of~     SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a~     single oral dose of each formulation, with five formulations of SB-751689 tested in total.~     Blood samples will be taken up to 24 hours postdose after each dose administration. This~     study will provide information for future possible formulation development of SB-751689 for~     Phase III.~   "
230393|NCT00540865|"~     This study will compare the effectiveness of case management combined with problem-solving~     therapy (CM-PST) versus case management (CM) alone for assisting elderly people with~     depression.~   "
230394|NCT00540852|"~     Optimal management of patients with locally advanced breast cancer remains a complex~     therapeutic problem. Newly diagnosed breast cancers in the United States with a higher~     incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant~     chemotherapy still remains controversial due to the difficulty of evaluating response to~     therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant~     chemotherapy.~   "
230395|NCT00540839|"~     A study to determine the effects of montelukast (MK-0476) on pediatric participants with~     chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of~     treatment, montelukast will provide at least the same level of asthma control as inhaled~     fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of~     treatment, daily administration of montelukast will be safe and well tolerated in children~     aged 6 months to 5 years with chronic asthma.~      This trial was stopped at a time before any participants had actually entered the trial.~     Based on input from regulatory agencies, it is not necessary to conduct this study; a~     separate ongoing study was sufficient for regulatory purposes.~   "
230396|NCT00540826|"~     The primary research objective of this observational study is to evaluate treatment~     compliance over one year in children and adolescents who are newly initiated on medication~     approved for the treatment of ADHD in a routine clinical setting. Compliance will be assessed~     using the Pediatric Compliance Self-Rating (PCSR) Instrument. A patient will be considered as~     compliant at a given visit, if the PCSR score is at least 5, corresponding to taking the~     medication at least often.~   "
230397|NCT00540813|"~     The aim of the study is to investigate the feasibility of Paclitaxel-eluting PTCA-balloon~     dilation (SeQuent Please) followed by bare metal stent (Coroflex ) deployment in the main~     branch (reference diameter: ≥ 2.5 mm and ≤ 3.8 mm, reference diameter of side branch: ≥ 2.0~     mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 20 mm) in the treatment of significant~     (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native left~     coronary artery as reflected by procedural success and to evaluate the preservation of vessel~     patency.~   "
230398|NCT00540800|"~     Some chemotherapies, including docetaxel, are better tolerated and just as effective when~     giving the dose weekly rather than on an every three week basis. The purpose of this study is~     to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality~     of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for~     metastatic or locally advanced breast cancer.~   "
230399|NCT00540787|"~     The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic~     drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation~     patients.~   "
230400|NCT00540774|"~     Overall objective of this work is to identify optical properties of healthy, diseased,~     dysplastic and malignant oral tissues, to compare these with conventional diagnostic~     approaches such as standard of care clinical techniques as well as semi-quantitative~     histo-pathological assessment and potential biomarkers in oral tissues and fluids to (1) gain~     a better understanding of processes involved in oral pathology and (2) develop a combined~     patient specific, non-invasive method for the detection, diagnosis and screening of oral~     pathology. Thus our goal is to identify and evaluate microstructural, metabolic, vascular,~     protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict~     and map oral pathology, especially neoplasia.~      We are recruiting patients with a wide range of oral conditions including plaque, dry mouth,~     toothache, root canal treatments, gum disease, oral sores, dysplasia and cancer, autoimmune~     conditions and others as well as healthy control subjects. We will use a range of~     non-invasive imaging modalities to obtain information on the ways in which the oral health~     status affects optical properties, and determine means of detecting and quantifying these~     factors.. Imaging modalities to be utilized include:~        1. Coherence and Doppler Tomography~        2. Laser Speckle Imaging~        3. Various forms of Spectroscopy~        4. Fluorescence~   "
230401|NCT00540761|"~     Atherosclerosis, a condition in which fatty deposits of plaque build up along the inner walls~     of arteries, is a condition that may increase the risk of having a heart attack. Previous~     studies have shown that the presence of a specific kind of plaque, known as vulnerable~     plaque, is often found in people who have had a heart attack. This study will use a new~     imaging technique called optical frequency domain imaging (OFDI) to examine the presence of~     vulnerable plaques in people with coronary artery disease.~   "
230402|NCT00540748|"~     This is a randomized, single-blind study using oxytocin 5U i.v. during surgical abortion in~     one arm of the study, and no medication in the other arm of the study. Comparison is done~     between the two groups measuring the following outcomes: pain, nausea and blood loss. The~     investigators' hypothesis is that there will be no significant differences between the two~     groups.~   "
230403|NCT00540735|"~     Unresectable type III or IV cholangiocarcinoma has a very bad prognosis; survival median~     ranges between 6 and 9 months.~      Survival depends on biliary drainage quality, obtained by plastic or metallic prothesis~     setting up in one or several hepatic segments.~      Radiotherapy and/or chemotherapy didn't prove yet their efficiency on survival. In France,~     gemcitabin is recommended by the French Digestive Oncology Federation in metastatic tumours,~     in monotherapy or associated with cisplatin or oxaliplatin (Gemox) for patients in good~     general condition.~      Photodynamic therapy has shown in 3 prospective studies - one randomized - with small patient~     series, a significative efficiency on survival and quality of life of treated patients, in~     comparison with historical series, or patients' groups whose biliary drainage was in most~     cases unefficient.~      A new randomized study, including patients whose biliary drainage is efficient and comparing~     their becoming when they are treated by PDT in addition to current practice, or only by~     current practice, seems to be justified.~      The principal objective of this study is to evaluate the efficiency of PDT with Photofrin® on~     patients with unresectable type III or IV cholangiocarcinoma.~   "
230404|NCT00540722|"~     This phase II trial is studying how well gossypol works in treating patients with progressive~     or recurrent glioblastoma multiforme. Gossypol may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
230405|NCT00540709|"~     Whether a once-daily basal injection of insulin glargine with mealtime injections of insulin~     lispro achieves equivalent glycaemic control (HbA1c) to administration of insulin lispro by~     continuous subcutaneous insulin infusion in Type 1 diabetic patients.~   "
230406|NCT00540696|"~     The purpose of this study is to develop a functional capacity screening tool (FCST) that~     estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies~     receiving multicycle chemotherapy.~      Sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional~     capacity questionnaires. The questionnaires will be used to develop the FCST. Subjects will~     participate in the Modified Harvard Step Test (MHST) at required timepoints and receive~     darbepoetin alfa once every 2 weeks for 15 weeks. All subjects will return for a follow-up~     visit 2 weeks after the last dose of darbepoetin alfa.~   "
230407|NCT00540683|"~     The researcher can use Diffuse Optical spectroscopy technique that uses harmless levels of~     near-infrared light to probe the concentrations and states of important physiological~     molecules such as hemoglobin water and lipids in human muscle,.~   "
230408|NCT00540670|"~     The purpose of this study is to assess the safety and tolerability of E5555 in Japanese~     subjects with coronary artery disease.~   "
230409|NCT00540657|"~     The purpose of this study is to determine whether CCX282-B is effective in mitigating the~     effects of gluten ingestion in patients with celiac disease~   "
230414|NCT00540592|"~     In order to find the formulation leading to a maximal increase of the immune response while~     maintaining an acceptable safety profile, this study is designed to evaluate the~     immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals'~     influenza vaccine administered in adults aged 65 years and older compared to Fluarix.~   "
230415|NCT00540579|"~     Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition~     - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development~     as part of induction chemotherapy regimens for solid tumors. This study in pancreatic cancer~     is designed to determine the appropriate CC-4047 dose and regimen in combination with~     gemcitabine.~   "
230416|NCT00540566|"~     This study is to compare the ability of optical biopsy. Research can use light enters the~     skin, collected, analyzed by the computer, and a picture created for the pathologist to~     conventional histologic examination compare with the pathologist looking at the piece of~     tissue through a microscope makes the diagnosis.~   "
230417|NCT00540553|"~     This research study is the first administration of GSK971086 in humans. The purpose of this~     study is to assess the safety and tolerability of GSK971086, as well as, how much GSK971086~     is in your blood after different doses~   "
230418|NCT00540540|"~     Approximately twelve percent of the women in the United States will develop breast cancer,~     the most common form of cancer affecting women, with 183,000 new cases projected for 1995.~     Despite the increasing incidence, the age-adjusted death rate from carcinoma has remained~     relatively stable. Although the reason for this has not yet been demonstrated, this stability~     may be a direct consequence of early detection and improved therapy. Screening mammography as~     an early detection technique has been shown to reduce mortality by 23%. Mammographic~     abnormalities that go on to biopsy show 24% being positive for malignancy with great~     variability (6-75%). Breast biopsy is an expensive procedure with the risks of anesthesia and~     surgery which may be obviated by more specific non-invasive testing.~   "
230419|NCT00540527|"~     The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an~     ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours,~     increases the proportion of independent survivors at 3 months.~   "
230420|NCT00540514|"~     The purpose of this study is to compare disease response of Albumin-bound paclitaxel~     (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients~     with advanced non-small cell lung cancer (NSCLC).~   "
230421|NCT00540501|"~     This study is a 4 period study to see if there is any interaction between Orally-Administered~     Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects~   "
230422|NCT00540488|"~     To measure and compare the glycemic and insulinemic responses of subjects consuming a~     standard and two diabetes-specific products.~   "
230423|NCT00540475|"~     The Pennsylvania Idiopathic Pulmonary Fibrosis State-wide Research Registry (PA-IPF) is a~     cooperative project between five medical centers to coordinate a team of investigators. The~     aim of this registry will be: 1) To assess the extent of lung fibrosis in the commonwealth of~     Pennsylvania 2) To provide better access of patients with pulmonary fibrosis in all regions~     of Pennsylvania to standard of care and diagnosis 3) To facilitate the translation of new~     therapeutic interventions from the bench to the bedside.~   "
230424|NCT00540462|"~     Although intensive medical treatment of diabetes has clearly been demonstrated to be~     worthwhile, it has not been a total success in diabetes treatment for a variety of reasons~     including lack of response to medication. Diabetes has been well demonstrated as a~     co-morbidity illness of obesity patients. In observation, with exclusion stomach and duodenum~     of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes~     had a significant improved of sugar control. Base of this observation, we will try to find~     out the role surgical intervention (gastric bypass & sleeve gastrectomy) in obese-related~     diabetes.~   "
230425|NCT00540449|"~     The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278~     given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily,~     when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir~     disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV~     drugs. The following evaluations will be done: antiviral activity, immunologic changes, and~     viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and~     PK/Pharmacodynamics, medical resource utilization and treatment adherence.~   "
230426|NCT00540436|"~     The primary objective of this study is to evaluate the effect of GSK1325760A on improvement~     in exercise capacity in subjects with pulmonary arterial hypertension (PAH).~      The secondary objectives of this study are to evaluate administration of GSK1325760A on:~        -  The safety and tolerability~        -  Improvement of PAH~        -  The steady-state plasma pharmacokinetics of GSK1325760A~   "
230427|NCT00540423|"~     This is a Phase II/III multicenter study comprising of the double-blind, followed by~     open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag~     (SB-497115-GR) in chronic ITP patients~   "
230428|NCT00540410|"~     Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and~     parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine,~     based on the first malaria attack of each subject.~      Secondary objectives:~      For the first attack: To compare the two groups of treatment in terms of:~        -  D14 efficacy~        -  Parasitological and fever clearance~        -  Clinical and biological tolerability~        -  Evolution of gametocyte carriage~        -  Cardiac tolerability (QTc)~      For the repeated attacks: To compare the two groups of treatment in terms of:~        -  D14 and D28 clinical and parasitological effectiveness (PCR adjusted)~        -  Clinical and biological tolerability~        -  Proportion of patients without fever at D3~        -  Proportion of patients without parasite at D3~        -  Compliance~        -  Impact on anaemia~      During the total follow-up of the cohort: To compare the two groups of treatment in term of:~        -  Treatment incidence density~        -  Impact of repeated treatment on clinical and biological safety~        -  Impact of repeated treatment on hearing capacity~   "
230429|NCT00540397|"~     To Elucidate and Confirm the Theory of XuSunShengJi in the Traditional Chinese Medicine~     Etiological Pathogenesis of Liver Cirrhosis.~   "
230470|NCT00539864|"~     The purpose of this study was to evaluate and compare the safety, reactogenicity,~     immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent~     influenza vaccine (TIV)in healthy adults age 50-64 years.~   "
230430|NCT00540384|"~     The purpose of this study is to assess the safety of NESP administered by SC injection in~     subjects with solid tumours and anaemia receiving multicycle chemotherapy.~      Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Schedule 1 is a~     sequential dose escalation study which consists of Parts A and B. Part A is the initial~     treatment phase, where the clinically effective dose (CED) of NESP administered every 3 weeks~     will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label,~     dose-maintenance phase that follows Part A.~      Schedule 2 is a parallel dose-finding study and also consists of Parts A and B. Part A is the~     initial treatment phase, where the CED of NESP administered every 4 weeks will be determined~     after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance~     phase that follows Part A.~   "
230431|NCT00540371|"~     The purpose of the study is to improve the efficacy of pulsed dye laser treatment of port~     wine stain birthmarks. Involvement in the protocol will involve formal documentation of the~     level of treatment pain, duration of post-treatment purpura and incidence of side effects. In~     addition, measurements will be taken of blood substances that promote blood vessel~     formation/regrowth and non-invasive reflectance measurements and photographs will be taken~     before and after treatment.~      The objective of this study is to document the degree of port wine stain lightening, the~     incidence of side effects and the presence of angiogenic factors induced during treatment~     with the pulsed dye laser in association with cooling agent. This information ultimately lead~     to improved treatment.~   "
230432|NCT00540358|"~     The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with~     standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor~     (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast~     cancer patients improve clinical benefit compared to treatment with standard chemotherapy~     alone.~      Based on data generated by BiPar/Sanofi, it was concluded that iniparib does not possess~     characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact~     mechanism has not yet been fully elucidated, however based on experiments on tumor cells~     performed in the laboratory, iniparib is a novel investigational anti-cancer agent that~     induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in~     the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging~     modalities in tumor cell lines. Investigations into potential targets of iniparib and its~     metabolites are ongoing.~   "
230433|NCT00540345|"~     The purposes of this study are:~        1. To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in~          combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV)~          genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a~          rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of~          treatment).~        2. To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon~          alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve~          chronic hepatitis C patients who have no RVR.~   "
230434|NCT00540332|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin~     on the incidence of oral mucositis in subjects with locally advanced head and neck cancer~     receiving postoperative radiotherapy.~   "
230435|NCT00540319|"~     Pregnancy is a critical time to address preventable behavioral risks that pose serious~     threats to the health of both the mother and the developing fetus. We propose to conduct a~     randomized, controlled trial to determine the extent to which the Health in Pregnancy (HIP)~     program, a brief motivational intervention featuring a Video Doctor, provider cueing~     sheets, and patient educational worksheets, can reduce pregnant women's cigarette smoking,~     alcohol drinking, illicit drug use, and domestic violence risks compared with usual care.~   "
230436|NCT00540306|"~     The purpose of this study is to do determine the changes in physiological and optical~     properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse~     Optical Spectroscopy. The Researcher can determine 1) how large variations in breast tissue~     components are 2) how predictable and repeatable these variations are 3) the effects of~     endogenous hormones on breast tissue physiology.~   "
230437|NCT00540293|"~     To evaluate the percentage of Korean dyslipidemic subjects in the total group and each~     cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at~     starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.~   "
230438|NCT00540280|"~     Randomized Phase III trial of surgery alone or surgery plus preoperative~     Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer~   "
230439|NCT00540267|"~     People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk~     groups for developing osteoporosis.~      To evaluate the prevalence of bone mineral density in men patients with schizophrenia with~     alcohol abuse, the investigators will compare bone mineral density between patient with~     schizophrenia with and without alcohol abuse.~   "
230440|NCT00540254|"~     The purpose of this study is to determine how best to manage the sleep problems of people~     with Chronic Fatigue Syndrome. This study is being conducted to determine how improvements in~     sleep affect other Chronic Fatigue symptoms including pain, fatigue, and mood as well as a~     person's sense of general well-being.~   "
230441|NCT00540241|"~     The primary research objective of this observational study in pretreated patients with NSCLC~     of Stage IIIa/b or Stage IV is to evaluate patients' Karnofsky Index (KI) after the second~     cycle of second-line treatment with single agent pemetrexed in a real life setting, and to~     evaluate factors potentially influencing performance status in terms of KI, i.e. frequency of~     use of concomitant medications, in particular analgesics, folic acid, Vitamin B12,~     antiemetics, and medications against diarrhea; as documented in patient diary (days of use~     per week) and by the physicians.~   "
230442|NCT00540228|"~     In order to find the formulation leading to a maximal increase of the immune response while~     maintaining an acceptable safety profile, this study is designed to evaluate the~     immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals'~     influenza vaccine administered in adults aged 18-64 years.~   "
230471|NCT00539851|"~     This study is proposed to investigate the incidence of Post Transplant Diabetes Mellitus~     (PTDM) as well as associated risk factors for the development of PTDM in patients undergoing~     allogenic stem cell transplantation.~   "
230443|NCT00540215|"~     It is the study aim to investigate the effect of glp-2 on blood flow in humans. we wish to~     study eventual changes in renal blood flow, carotic blood flow and cardiac out put.~      GLP-2 will be administered subcutaneously, and the effect monitored by doppler ultra sound~     scannings and cotinuesly measuring of cardiac out put and blood pressure.~      The study will include 15 healhty volunteers, 10 wil receive 450 nmol GLP-2 and 5 will~     receive 1 ml of isotonic saline (as baseline reference).~   "
230444|NCT00540202|"~     We will test the hypothesis that there is a difference in effectiveness of oral quinine in~     comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.~   "
230445|NCT00540189|"~     To determine the most cost effective way to treat children with perforated appendicitis we~     will randomize all children presenting with perforated appendicitis to initial operation,~     with in 24 hours of admission, or to initial antibiotics, with or without percutaneous~     drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost,~     complications, length of stay, and quality of life measures.~   "
230446|NCT00540176|"~     Malignant gliomas, which include Glioblastoma multiforme (GBM), are the most common and most~     aggressive types of brain cancer, accounting for approximately 60% of primary brain tumors.~     These tumors are characterized by diverse molecular abnormalities (within the same tumor),~     which, along with the difficulties of many standard chemotherapies crossing the blood~     barrier, contribute to the very poor response to therapy and poor survival.~      We recently showed that Dichloroacetate (DCA, an inhibitor of the mitochondrial pyruvate~     dehydrogenase kinase) was able to depolarize cancer (but not normal) mitochondria and induce~     apoptosis in cancer but not normal tissues. We believe that altering the metabolism of~     cancers like glioblastoma (DCA switches metabolism from the cytoplasmic glycolysis to the~     mitochondrial glucose oxidation) we inhibit the resistance to apoptosis that characterizes~     cancer. Because metabolism (i.e. glycolysis) is the end result of many and diverse molecular~     pathways, the effects of DCA might be positive in cancers with diverse molecular backgrounds.~     DCA is also a very small molecule that readily crosses the blood brain barrier. Therefore we~     hypothesize that DCA will be an effective and relative non-toxic potential therapy for~     malignant gliomas.~      We are conducting a phase II trial with 2 parallel arms: a) patients with newly diagnosed~     malignant gliomas and b) patients with recurrent gliomas or gliomas that have failed standard~     therapy (which includes surgery, radiotherapy and chemotherapy). All patients need to have a~     histological diagnosis. DCA will be given orally and patients will be followed for a minimum~     of 6 months. The tumor size will be followed by standard MRI or CT criteria and glucose~     uptake (a direct effect of DCA on the tumor) will be measured by FDG-PET imaging. Several~     clinical parameters and quality of life will be followed. Potential toxicity (particularly~     peripheral neuropathy) will be closely followed and dose-de-escalation protocols are in place~     in case of toxicity. In addition, escape protocols for the application of standard therapy~     (when appropriate) are in place in patients with no evidence of response to DCA. In vitro~     studies will be performed in the tissues obtained at the time of surgery (where appropriate)~     and correlated prospectively with clinical data.~      There is limited ability to accept patients outside of Alberta; this is in part because the~     visit and testing schedule is intense, requiring residence in Edmonton for at least 6 months.~   "
230447|NCT00540163|"~     This observational non-interventional study is designed to demonstrate the improvement of~     physical function in COPD patients with exercise-induced dyspnoea on treatment with Spiriva~     (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.~   "
230448|NCT00540150|"~     We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in~     contrast to the standard specific immunotherapy.~      Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22~     patients for 6 weeks with the shortened scheme.~   "
230449|NCT00540137|"~     The purpose of this study is to investigate the possibility of an association between changes~     in neurocognitive function, as measured by a computerised test battery, and the use of two~     different highly active antiretroviral therapy (HAART) regimens in treatment naïve HIV-1~     infected subjects commencing antiretroviral therapy.~   "
230450|NCT00540124|"~     The primary purpose of this clinical trial is to evaluate the change in the International~     Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the~     study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day~     dosing for 12 weeks of treatment.~   "
230451|NCT00540111|"~     The purpose of this study was to assess the effect of soluble fiber® (partially hydrolyzed~     guar gum) supplementation on hypertriglyceridemia and immune profile in HIV-positive~     individuals on HAART.~   "
230452|NCT00540098|"~     Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination~     with regular aerobic exercise (running) or regular relaxation training in the treatment of~     panic disorder.~   "
230453|NCT00540085|"~     Aim: To optimize the use of rocuronium (a neuromuscular blocking agent) in obese patients~     undergoing gastric bypass or gastric banding.~      Background: During general anaesthesia, a neuromuscular blocking agent is needed to allow~     surgery and airway management. Optimal dosing is important in order to avoid inadequately~     muscle relaxation, but also to avoid overdosage, which can result in prolonged anaesthesia~     and respiratory complications.~      Main hypothesis: Rocuronium dosed according to ideal body weight results in shorter duration~     of action compared to rocuronium dosed according to corrected body weight without prolonged~     onset time or compromised airway management or surgical demands for muscle relaxation.~   "
230454|NCT00540072|"~     A COMPARASON OF CIDECIN™ (DAPTOMYCIN) TO ROCEPHIN® (CEFTRIAXONE) IN THE TREATMENT OF MODERATE~     TO SEVERE COMMUNITY-ACQUIRED ACUTE BACTERIAL PNEUMONIA DUE TO S. PNEUMONIAE~   "
230455|NCT00540059|"~     Purpose of this study is the evaluation of QoL, tolerability and use of Zoladex 10,8~     SafeSystem for advanced PCa under naturalistic conditions~   "
230456|NCT00540046|"~     The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380~     IUD after termination of pregnancy after 12 weeks.~   "
230457|NCT00540033|"~     We investigate the efficacy of probiotics in reducing the incidence and severity of~     necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective,~     masked, multi-center randomized control trial will be conducted level III neonatal center to~     evaluate the beneficial effects of probiotics for NEC among VLBW (<1500 g) infants. VLBW~     infants who start to feed enterally are eligible and are randomized into 2 groups after~     parental informed consents were obtained. Infants in the study group are fed with Infloran~     (Lactobacillus acidophilus and Bifidobacterium bifidus) with breast or formula milk twice~     daily for 6 weeks. Infants in the control group are fed with breast or formula milk alone.~     The clinicians caring for the infants are blinded to the group assignment. The primary~     outcome measurement is death or NEC (≧stage 2).~   "
230484|NCT00539669|"~     Evaluate response rate of Docetaxel in combination with Carboplatin or Cisplatin as first~     line chemotherapy in epithelial ovarian cancer. Assess the progression free survival,~     tolerance, duration of response and survival in the same patient population.~   "
230458|NCT00540020|"~     Context: Traumatic brain injury (TBI) is a common condition associated with significant~     long-term cognitive, behavioral, and functional morbidities. There are minimal controlled~     efficacy data of various acute rehabilitation intervention approaches.~      Objective: To determine the relative efficacy of two different acute TBI rehabilitation~     approaches - cognitive-didactic versus functional-experiential. Secondarily to determine~     relative efficacy for different patient subpopulations based on baseline cognitive~     functioning.~   "
230459|NCT00540007|"~     The purpose of this study is to determine the efficacy of lenalidomide in the treatment of~     relapsed or refractory classic Hodgkin lymphoma(cHL).~   "
230460|NCT00539994|"~     This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the~     safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3~     or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S.~     aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be~     enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19~     intermittent carriers complete the study. Each eligible subject will participate in three~     screening visits, a treatment period, and two follow-up visits. Each subject's participation~     in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit.~     Subjects will participate in up to three screening visits to determine S. aureus culture~     positivity and colonization status.~   "
230461|NCT00539981|"~     The purpose of this study was to evaluate a single dose of FluBlok in terms of safety,~     efficacy and effectiveness in prevention of influenza and influenza-like illness and assess~     clinical lot-to-lot consistency in manufacturing by evaluating and comparing the~     immunogenicity of three different lots of FluBlok in a subset of subjects.~   "
230462|NCT00539968|"~     This study will determine the best doses of docetaxel and lonafarnib when the two anti-cancer~     agents are used in combination. Patients with tumors for which treatment with docetaxel would~     be appropriate are eligible. A second part of the study will further examine the~     effectiveness of the combination treatment in men with prostate cancer.~   "
230463|NCT00539955|"~     The goal of this project is to examine whether, relative to standard care, violence and~     alcohol use outcomes can be improved by a brief, motivationally based adjunct alcohol~     treatment for men enrolled in batterer intervention programs. We hypothesize that men~     randomized to also receive the brief alcohol intervention will have better partner violence~     and alcohol use outcomes than men who are randomized to the batterer intervention program~     alone.~   "
230464|NCT00539942|"~     This is a randomized trial to compare intermittent compression devices with or without~     post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for~     known or presumed gynecologic malignancies. This trial seeks to determine if there is a~     difference in the rate of deep venous thrombosis between these two groups.~   "
230465|NCT00539929|"~     This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical~     administration to pre-identified marker lesions in adult subjects with chronic plaque type~     psoriasis. Treatment duration is 8 weeks, followed by a 4-week period without treatment.~     Pharmacokinetic samples will be obtained pre-and post treatment.~   "
230466|NCT00539916|"~     Epidemiological studies definitively show that fruit and vegetable consumption is positive~     for health and more specifically for cardiovascular diseases (CVD) prevention. In France,~     among fruits, those which are the most frequently consumed are citrus fruits essentially as~     juices and more specifically as orange juices. However, their health effects have been poorly~     studied so far. Citrus fruits contain vitamin C associated with various phytomicronutrients~     i.e. carotenoids (essentially -cryptoxanthin) and polyphenols. Each fruit contains specific~     compounds: hesperetin in orange, naringenin in grapefruit, eriodyctiol in lemon. Some~     scientific studies performed either in vitro or in animal models demonstrated properties of~     these micronutrients which could contribute to a positive health effect of citrus fruits on~     vascular protection. However data are still missing.~      The main goal of this project is to characterize the effect of orange juice consumption on~     vascular disease risk factors and to evaluate the specific role of their micronutrient~     compounds (polyphenols and carotenoids) in this protection. To reach this goal, a randomized~     cross-over clinical study will be performed on volunteers presenting a mild~     hypercholesterolemia. They will consume for 4 weeks an orange juice or a reconstituted drink~     similar to the orange juice for its composition in carbohydrates, minerals, vitamin C and~     folates but without phytomicronutrients. The effect of the juice consumption on the vascular~     function will be monitored exploring lipid abnormalities in plasma, measuring endothelial~     vasoreactivity (FMD) (Flow Mediated Dilatation), as well as endothelial dysfunction,~     thrombosis, inflammation and oxidative stress biomarkers in plasma. Comparison of urinary~     metabolomes after orange juice consumption or that of the reconstituted drink will lead to~     the identification of the metabolic pathways modulated by the orange juice micronutrients.~      Moreover ELISA tests for the two major flavanones from citrus fruits (hesperetin and~     naringenin) will be developed. They will be used to determine the plasma levels of these~     molecules in order to analyze the relation ingested quantity - bioavailable quantity -~     physiological effect.~      The results obtained in this project will allow clarifying citrus fruit effects, and~     particularly orange juice, in vascular protection.~   "
230467|NCT00539903|"~     There is today a growing need for culturally adapted initiatives among immigrants to prevent~     and treat T2D. Others have failed to increase the level of physical activity in this sedate~     group. The investigators believe this is due to missing assistance and lack of influence from~     the Pakistani milieu. To improve this, a culturally adapted physical activity will be~     established in this project in close cooperation with the Pakistanis themselves.~      Through this program it is the investigators' goal to increase their physical activity level~     and prevent lifestyle diseases among Pakistanis in Oslo with a high risk of developing these~     diseases.~   "
230468|NCT00539890|"~     To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting,~     subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c~     >7.0% and <11.5%.~   "
230469|NCT00539877|"~     Stomach cancer is the most common cancer, and is still leading cause of death in Korea.~     Peritoneal seeding is the most common metastases of gastric cancer, and is the most frequent~     cause of death from this disease. In addition, there is no standard treatment for peritoneal~     dissemination. Even though systemic intravenous chemotherapy is the standard treatment for~     metastatic stomach cancer at present, it does not improve the survival of patients with~     peritoneal dissemination. Because intraperitoneal(IP) administration results in high~     concentration locally with low systemic toxicity, clinical investigators have confirmed the~     safety and pharmacokinetic advantage associated with IP delivery of a number of~     antineoplastic agents with known activity in cancer. In ovarian cancer, a large randomized~     trial demonstrated a small but statistically and clinically significant survival advantage~     for women receiving a portion of their therapy intraperitoneally. Drugs such as~     5-fluorouracil, cisplatin, mitomycin-C, paclitaxel and docetaxel are used for IP chemotherapy~     in patients with gastric cancer. Even the small number of phase III trials reported, some~     studies showed improvement in survival for patients randomized to IP therapy compared to~     those receiving no postoperative treatment.~     Irinotecan(7-ethyl-10-[4-(1-pipperidino)-1-piperidino] carbonyloxy camptothecin; CPT-11),~     clinically effective in the treatment of colorectal, lung and gastric cancer, is a carbamate~     prodrug metabolized to its active metabolite, 7-ethyl-10-hydroxycamptothecin (SN-38). In~     mouse model, IP administration of CPT-11 was significantly more effective than intravenous~     administration for control of both peritoneal seeding and liver metastasis. However,~     phamacokinetics of CPT-11 with peritoneal administration in human beings is not well studied.~     Although Japanese investigators reported pharmacokinetic data of CPT-11 with few patients,~     there is no data about maximum tolerated dose of CPT-11 intraperitoneally.~   "
230472|NCT00539838|"~     This is a Phase III, randomized, double blind, placebo-controlled, multicenter,~     parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo~     when combined with a single stable background immunosuppressive medication and a~     corticosteroid regimen in patients with moderately to severely active systemic lupus~     erythematosus, who do not have moderate to severe glomerulonephritis.~   "
230473|NCT00539825|"~     GSK704838C is a potent, pan-active mAChR antagonist, which is being developed for once-daily~     treatment of chronic obstructive pulmonary disease (COPD).~   "
230474|NCT00539812|"~     The purpose of this study is to examine whether adding a brief alcohol treatment to standard~     violence intervention programs for women will result in reduced drinking, reduced partner~     violence perpetration, and reduced partner violence victimization. We hypothesize that,~     relative to standard care, women receiving the additional brief alcohol intervention will~     have better alcohol use and partner violence outcomes.~   "
230475|NCT00539799|"~     There is debate as to whether long-term low-dose steroids such as prednisolone help to~     suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from~     their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects~     may be counter-balanced by the long-term side-effects associated with prednisolone. This~     pilot study will determine the feasibility of conducting a larger randomized control trial~     that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5~     mg/day) reduces the flares of SLE in patients with previous lupus nephritis.~   "
230476|NCT00539786|"~     PPI test;empirical trial with high-dose proton-pump inhibitors (PPIs) has been shown to be a~     sensitive tool for diagnosing patients with GERD. However, this diagnostic strategy has not~     been well established in patients with extraesophageal manifestation of GERD. In this study,~     we aim to see the relevance of PPI test in diagnosing GERD in patients with extraesophageal~     symptoms.~   "
230477|NCT00539773|"~     Phase II Trial of concurrent administration of intravesical BCG & Interferon in the treatment~     and prevention of recurrence of superficial transitional carcinoma of the urinary bladder.~   "
230478|NCT00539760|"~     GSK182771 is a domain antibody targeting the interleukin (IL)-1 receptor which is being~     developed for the treatment of rheumatoid arthritis. This study is being done in healthy~     volunteers to verify the safety and tolerability of GSK182771~   "
230479|NCT00539747|"~     This exploratory study will examine ways in which individuals approach a positive genetic~     test for Huntington Disease (HD). HD is a neurodegenerative disorder that causes emotional,~     cognitive, and movement problems, and currently there is no way to prevent, stop or reverse~     the progression of the disease. It is passed down through a mutation in a normal gene, and~     each child of an HD parent has a 50-50 chance of inheriting the HD gene. The study is~     designed to explore how individuals adjust to their new genetic status and evaluate any~     perceived mental or emotional barriers to that adjustment. Currently, little is known about~     how individuals come to terms with a positive genetic test result for a condition that has no~     known cure or effective treatment. The results of this study may give health care providers~     and counselors more information about how to help patients who are at risk for developing HD~     make sense of their new genetic status.~      Candidates will be prescreened and referred to the study by clinics that specialize in~     genetic testing and counseling. Candidates must be 18 years old or older and must have~     received a positive genetic test result for HD at least one month prior to the study. They~     must also perceive themselves to be asymptomatic-that is, without existing HD symptoms.~      During the study, participants will be interviewed and asked a series of questions about~     their decision to pursue testing, their life since the testing, and the things that they have~     found helpful or unhelpful since receiving the test results. The interviews will be recorded~     and will last approximately 60 minutes. Participants also will receive a follow-up phone call~     within two to three days to ensure their general psychological well-being after the~     interview.~   "
230480|NCT00539734|"~     Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal~     growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits~     the growth of new vessels and has recently been approved by FDA for treating this condition.~     This study is carried out to evaluate the changes in retinal function after an injection of~     ranibizumab.~   "
230481|NCT00539721|"~     This is a multicenter, randomized, controlled study in women who are having elective open~     abdominal surgery with general anesthesia and who are expected to need patient-controlled~     analgesia (PCA) after surgery. The primary objective is to assess the effect of rolapitant in~     the prevention of postoperative nausea and vomiting as measured by the prevention of vomiting~     in the first 24 hours after surgery. Participation in the study may last up to 3 months. The~     total duration of the study will be approximately 36 weeks.~   "
230482|NCT00539708|"~     The purpose of this study is to assess the efficacy of noninvasive ventilation in the~     prevention of extubation failure and mortality in patients with chronic respiratory disorders~     and hypercapnic respiratory failure during spontaneous breathing.~   "
230483|NCT00539695|"~     Patients are being asked to participate in this study because treatment for their disease~     requires a stem cell transplant (SCT). Stem cells are the source of normal blood cells found~     in the bone marrow and lead to recovery of blood counts after bone marrow transplantation.~     With stem cell transplants, regardless of whether the donor is a full match to the patient or~     not, there is a risk of developing graft-versus-host disease (GVHD).~      GVHD is a serious and sometimes fatal side effect of SCT. GVHD occurs when the new donor stem~     cells (graft) recognizes that the body tissues of the patient (host) are different from those~     of the donor. When this happens, cells in the graft may attack the host organs. How much this~     happens and how severe the GVHD is depends on many things, including how different the donors~     cells are, the strength of the drugs given in preparation for the transplant, the quality of~     transplanted cells and the age of the person receiving the transplant.~      Typically, acute GVHD occurs in the first 100 days following transplant, while chronic GVHD~     occurs after day 100. Acute GVHD most often involves the skin, where it can cause anywhere~     from a mild rash to complete removal of skin; liver, where it can anywhere from a rise in~     liver function tests to liver failure; and the gut, where it can cause anywhere from mild~     diarrhea to profuse, life-threatening diarrhea. Most patients who develop GVHD experience a~     mild to moderate form, but some patients develop the severe, life-threatening form.~      Previous studies have shown that patients who receive SCT's can have a lower number of~     special T cells in their blood, called regulatory T cells, than people who have not received~     stem cell transplants. When regulatory T cells are low, there appears to be an increased rate~     of severe, acute GVHD. A drug known as IL-2 (Proleukin) has been shown to increase the number~     of regulatory T cells in patients following stem cell transplant, and in this study~     investigators plan to give low dose IL-2 after transplant.~      This study is called a phase II study because its major purpose is to find out whether using~     a low-dose of IL-2 will be effective in preventing acute GVHD. Other important purposes are~     to find out if this treatment helps the patient's immune system recover regulatory T cells~     faster after the transplant. This study will assess the safety and toxicity of low-dose IL-2~     given to patients after transplantation and determine whether this drug is helpful in~     preventing GVHD.~   "
230485|NCT00539656|"~     This study is to evaluate the safety of transplantation of two cord blood products, including~     toxicities in patients following high-dose, myeloablative chemotherapy for blood~     malignancies. It is also to determine if the use of two cord products results in an~     improvement in neutrophil engraftment.~   "
230486|NCT00539643|"~     The purpose of this study is to evaluate the effect of blocking the blood vessels to the~     tumor in your liver with small beads alone (Bead Block) versus blocking them with the same~     bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study~     is to see if adding doxorubicin kills more tumor than would be killed by just blocking the~     blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to~     treat patients with cancer. This procedure to block the blood vessels is called embolization.~     Embolization is a common treatment for patients with liver cancer who cannot have surgery.~     The investigators are comparing the standard treatment (using the small beads alone) with~     another that should be at least as good, but possibly better (with the addition of the drug,~     doxorubicin). There is no guarantee that the new treatment is better and it is possible that~     there might be more side effects (related to the doxorubicin) than what is seen with the~     standard treatment.~   "
230487|NCT00539630|"~     To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU,~     versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.~   "
230488|NCT00539617|"~     The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in~     patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.~   "
230489|NCT00539604|"~     To determine if 16-64 slice multidetector CT (MDCT) can replace the invasive procedure in~     patients scheduled for coronary angiography in order to exclude the presence of CAD~   "
230490|NCT00539591|"~     The main goal of this study is to estimate the tumor response rate of temozolomide~     administered in combination with peginterferon alfa-2b to pediatric patients with~     unresectable Stage III, metastatic, or recurrent cutaneous melanoma.~   "
230491|NCT00539578|"~     The purpose of the study is to examine the safety and efficacy of MK0777 during treatment for~     Generalized Anxiety Disorder.~   "
230492|NCT00539565|"~     Biliary atresia is a congenital disorder of bile duct development or destruction of~     established but immature bile ducts. The study tests the hypothesis that post-operative~     steroids improve outcome following the Kasai procedure - the commonest surgical treatment.~   "
230493|NCT00539539|"~     The purpose of this study is to evaluate whether or not real-time feedback on CPR process~     variables will increase rates of restoration of spontaneous circulation during prehospital~     resuscitation and upon arrival at the receiving emergency room as well as increase rates of~     survival to hospital discharge.~   "
230494|NCT00539526|"~     This study will evaluate hyperemia and ocular surface tolerability in patients on~     prostaglandin analogues~   "
230495|NCT00539513|"~     Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal~     of suffering. Many patients benefit from established treatments, the mainstay of which are~     cognitive behavioral therapy and a group of antidepressant medications known as serotonin~     reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established~     therapeutic strategies. New avenues of treatment are urgently needed.~      Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin~     or dopamine; but increasing evidence suggests that functional disruptions of a different~     neurotransmitter, glutamate, may contribute to some cases of OCD. The researchers are~     therefore interested in using medications that target glutamate as novel treatment options~     for those OCD patients who do not benefit from established treatments.~      One such medication is the drug N-Acetylcysteine, whose glutamatergic antagonistic properties~     may be effective in reducing the glutamatergic hyperactivity that is thought to contribute to~     the pathophysiology of OCD and major depressive disorder (MDD).~      Riluzole, which is FDA approved for amyotrophic lateral sclerosis (ALS, or Lou Gehrig's~     disease) is also a glutamatergic agent. There is evidence that riluzole possesses~     anti-depressant, anti-obsessional, and anti-anxiety properties.~      The modulation of glutamatergic activity is a promising new approach to the treatment of mood~     disorders. The researchers are therefore now recruiting patients to participate in a~     double-blind, placebo-controlled trial of N-Acetylcysteine, added to whatever other OCD~     medications they are taking.~   "
230496|NCT00539500|"~     The goal of this clinical research study is to learn how long it takes for certain types of~     transplanted stem cells to produce new blood cells. The safety of this treatment will also be~     studied. Finally, researchers want to learn if collecting the cells with the CliniMACS device~     can decrease the possibility of tumor cells contaminating (appearing in) the stem cells that~     are reinfused into participants.~   "
230497|NCT00539487|"~     This observational non-interventional study will assess (under conditions of clinical~     practice in daily routine) the antihypertensive efficacy of telmisartan treatment with or~     without active promotion of lifestyle changes in hypertensive patients at high cardiovascular~     risk~   "
230498|NCT00539474|"~     Rationale:~      Approximately 25% of breast cancers detected are non palpable. Accordingly, a localization~     technique is required to help the surgeon to find and remove the cancer. The current~     technique (wire guided localization [WGL]) is difficult to perform and has a high rate of~     tumour positive margins in the resected specimen, requiring a second operation. A new~     approach in the localization and resection of non-palpable malignant breast lesions is 'radio~     guided occult lesion localization' (ROLL). ROLL was introduced as a possible replacement for~     WGL at the `European Institute of Oncology' in Milan in 1996. This technique utilizes the~     intratumourally injected radiotracer, that is generally used for the lymphatic mapping and~     SNB, to localize the primary tumour guided by the gamma probe. Five studies so far have~     proven the applicability of this method.~      Objective:~      To evaluate the efficacy of Radio Occult Lesion Localisation (ROLL) versus Wire guided~     Localisation (WGL) in breast conserving surgery for non-palpable breast cancer~      Study design:~      A multicenter, prospective randomized clinical trial. Patients with proven non-palpable~     breast cancer will be randomized for either ROLL or WGL.~      Study population:~      316 women with a core biopsy proven non palpable cT1 breast carcinoma that are eligible for a~     breast conserving treatment and sentinel node biopsy (SNB).~      Intervention (if applicable):~      Patients in the WGL group will undergo intra tumoural injection of a nuclear radiotracer~     under stereotactic or ultrasonographic guidance. After scintigraphic imaging, to monitor the~     migration of the radiotracer, a guide wire will be inserted under stereotactic or~     ultrasonographic guidance. The excision of the primary tumour is guided by the inserted wire~     and the sentinel node procedure is performed using a gamma probe and intratumoural injection~     of patent blue.~      Patients in the ROLL group will undergo the same procedure except for the guide wire~     insertion. The excision of the primary tumour is guided by the gamma probe.~      Main study parameters/endpoints:~      Primary study endpoints; ROLL vs WGL:~        1. The percentage of tumour-free margins (invasive and in situ)~        2. The volume and maximum diameter of the lumpectomy~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      There is no pre-, per- or post operative extra burden. The radiofarmacon is already used in~     the standard care of breast cancer patients for the sentinel node biopsy. The used~     radio-active substance does not damage the patient.~      A specific burden questionnaire, aimed at evaluating the burden of the cosmetic result, will~     be administered. To further assess the net impact in terms of Health Related Quality of Life~     (HRQoL) also the EQ5D will be obtained at T = 0, 6, 12 and 26 weeks after the initial~     diagnostic work-up.~      Should the results indicate that overall the WGL procedure lead to better clinical outcome a~     cost-effectiveness analysis is foreseen using bootstrapping to assess the uncertainty with~     regard to the balance between costs and effects. All analyses will be limited to a half year~     time horizon. Accordingly, discounting of costs or effects is not applicable.~   "
230499|NCT00539461|"~     In this German non-interventional observational study 1980 patients diagnosed with Restless~     Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal~     states in Germany. Both moderate to severe RLS patients, with or without previous RLS~     treatment, suffering from RLS symptoms like a desire to move the extremities usually~     associated with some discomfort, motor restlessness and worsening of symptoms at rest with at~     least temporary relief by activity, worsening of symptoms later in the day or at night, are~     eligible for this study, if it is planned to initiate therapy with pramipexole or to add~     pramipexole to a previously given, insufficient therapy. Three visits are planned to be~     documented in this PMS study, one baseline visit, visit two after the end of pramipexole~     titration and visit three after 12 weeks of treatment. Evaluations and visits are to be~     carried out and documented only if part of routine medical practice. The main goal of~     observational studies is to determine how pramipexole treatment works when applied in actual~     practice and thus maximise external validity. In actual practice patients who have been~     excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e.~     those with certain disease histories, co-morbidities and/or demographic characteristics) will~     be treated with PPX. Thus in addition during this observational study information on the~     efficacy and safety of PPX in those patients will be obtained. The objectives of this PMS~     study are:~        -  To evaluate the treatment effect of pramipexole on RLS severity and general improvement~          as measured by IRLS and CGI-I.~        -  To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome~          Quality of Life questionnaire (RLS-QoL).~        -  To evaluate the safety profile of PPX in a natural study population.~   "
230512|NCT00539292|"~     This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS)~     to treat infants with gastroschisis will result in improved outcomes, faster recovery times~     and fewer post-surgical complications than the standard selective use of the silo.~   "
230500|NCT00539448|"~     Primary objective :~      To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then~     after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type~     I diabetes mellitus.~      Secondary objective :~        -  Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I~          DM.~        -  Recording adverse events.~   "
230501|NCT00539435|"~     The purpose of this study is to determine if restoring normal metabolic function in patients~     with either type I or type II diabetes can improve the impact of the consequences of diabetic~     complications on heart disease in diabetic patients. Patients are treated once a week with~     pulsatile intravenous insulin therapy mimicking normal insulin secretion. A diabetic cardiac~     disease quality of life questionnaire is completed prior to the start of the treatment and~     monthly thereafter with detailed analysis performed to measure progress and outcomes. A~     carotid ultrasound and echocardiogram are performed at baseline and every six months to~     monitor progress.~   "
230502|NCT00539422|"~     The aim of our study is to investigate the potential role of the CYP2D6*4 polymorphism in~     breast cancer and furthermore to assess the role of oxidative stress, antioxidant capacity~     and ferretin in pathogenesis of breast cancer in different CYP2D6*4 genotypes~   "
230503|NCT00539409|"~     The purpose of this study is to determine if restoring normal metabolic function in patients~     with either type I or type II diabetes can improve the impact of the consequences of diabetic~     complications on the overall quality of life of diabetic patients. Patients are treated once~     a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A~     diabetic quality of life questionnaire is completed prior to the start of the treatment and~     quarterly thereafter with detailed analysis performed to measure progress and outcomes~   "
230504|NCT00539396|"~     A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to~     insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine~   "
230505|NCT00539383|"~     This is a phase 1, multi-centre, sequential cohort, open-label, dose-escalation study of the~     safety, tolerability, and PK of ANG1005 in patients with solid tumors (with or without brain~     metastases). ANG1005 will be given by IV infusion once every 21 days (1 treatment cycle).~     Each patient will participate in only 1 dose group and will receive up to 6 cycles of~     treatment provided there is no evidence of tumor progression, there is recovery to ≤Grade 1~     or baseline nonhematologic, ANG1005-related toxicity (except alopecia), the absolute~     neutrophil count is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L.~   "
230506|NCT00539370|"~     This protocol will enable IRB (institutional review board) review of proposed research using~     human samples and data collected under the terminated NIH studies 04-EI-0065 and 96-EI-0096.~     Data and samples may include demographic and personal health information, psychological or~     psychiatric testing, blood, urine, CSF or other body fluids or tissues and results of medical~     and physiological evaluation and medical imaging.~      Data and sample analyses are limited to those approved under the original protocols unless~     additional specific institutional review board approval is obtained.~   "
230507|NCT00539357|"~     Cranial electrotherapy stimulation(CES) is a noninvasive procedure that has been used for~     decades in the United States to treat anxiety, depression, and insomnia in the general~     population. Whether CES is an effective treatment for patients with a DSM-IV diagnosis of~     generalized anxiety disorder (GAD) has not previously been explored. The goal of this study~     was is to evaluate the efficacy of CES in alleviating anxiety in patients with~     DSMIV-diagnosed GAD. Specifically our hypothesis was that CES would demonstrate possible~     efficacy in reducing symptoms associated with GAD from baseline to end of trial, as~     determined by: (1) change from baseline in the Hamilton Anxiety Scale (HAM-A) total score.~     a.) the proportion of responders (much or very much improved) as assessed by the CGI~     Improvement ratings by visit b.) the proportion of responders (50% reduction from total HAM A~     baseline score) according to the HAM A scores by visit c.) the proportion of patients in~     remission (HAM A score ≤7) by visit~   "
230508|NCT00539344|"~     This is a phase 1, multi-centre, sequential cohort, open-label, dose-escalation study of the~     safety, tolerability, and PK of ANG1005 in patients with recurrent or progressive malignant~     glioma. ANG1005 will be given by IV infusion once every 21 days (1 treatment cycle). Each~     patient will participate in only 1 dose group and will receive up to 6 cycles of treatment~     provided there is no evidence of tumor progression, there is recovery to ≤Grade 1 or baseline~     nonhematologic, ANG1005-related toxicity (except alopecia), the absolute neutrophil count is~     ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L.~   "
230509|NCT00539331|"~     The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed~     AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small~     cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase~     II efficacy and tolerability analysis by the study's Data Safety Monitoring Committee.~     Although evidence of clinical activity was seen, there appeared to be an imbalance in~     toxicity and therefore the study was considered not to have met the pre-defined criteria for~     automatic continuation into Phase III. As the design of Study 040 is similar to that of Study~     BR24, AstraZeneca has suspended recruitment into Study 040.~   "
230510|NCT00539318|"~     The proposal seeks to establish:~        -  A comprehensive compilation (database) of clinical information comprising clinical,~          histopathological, treatment and follow-up characteristics of past and future~          gastrointestinal cancer (GIC) cases in Singapore that can be shared by investigators.~          The characteristics will include clinical (eg age, sex, stage), histopathological (eg.~          grade, type), treatment (eg. treatment status, regimens) and outcome data (eg. survival,~          toxicity) from medical records.~        -  A collection (bank) of corresponding frozen and fixed tissue, blood and processed~          samples (enriched blood mononuclear cells, protein, RNA, DNA, tissue arrays) in~          Singapore that can be shared by the investigators.~        -  A gastrointestinal cancer co-operative group (GCCG) of clinicians and scientists~          researching prognostic and predictive markers in GIC, which will benefit from the~          multidisciplinary knowledge, information and samples of its members.~   "
230511|NCT00539305|"~     The purpose of this study is to examine the effects of testosterone (T) replacement on~     changes in thinking and memory, as well as mood in older men with mild cognitive impairment~     (MCI) and low T levels. The study will also examine whether taking testosterone has effects~     on biological markers related to Alzheimer's disease.~   "
230513|NCT00539279|"~     This project represents the first randomized clinical trial of psychotherapy for older~     veterans with posttraumatic stress disorder (PTSD). It will compare relaxation training (RT)~     to prolonged exposure therapy (PE). The project will also examine whether cognitive~     impairment influences psychotherapy outcome.~      Primary hypotheses: (1) Subjects in the PE condition will have significantly less severe PTSD~     symptoms, depressive symptoms, and functional impairment than subjects in the RT condition at~     posttest; (2) Executive functioning will modify the response to both treatments, such that~     those with impaired executive functioning will demonstrate a smaller reduction in PTSD~     symptoms (representing less clinically significant change).~   "
230514|NCT00539266|"~     The investigators propose confirm and extend the findings of open studies on the apparent~     efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in~     patients with severe claudication or critical leg ischemia and pay special attention to the~     influence of diabetic disease on the outcome of the study and to the possible~     pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.~   "
230515|NCT00539253|"~     This research is being done to find out if using the contrast agent MultiHance can be used to~     show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial~     Chemoembolization (TACE).~   "
230516|NCT00539240|"~     The purpose of this project is to compare the efficacy (how successful) 1) standard-dose~     proton pump inhibitor (PPI) (rabeprazole 20 mg once daily) (a medication that completely~     blocks the stomach from producing acid) plus low dose tricyclic antidepressant (nortriptyline~     50mg) (TCA); 2) double-dose PPI (rabeprazole 20 mg twice a day); to 3) standard-dose PPI~     (rabeprazole 20mg once daily) and placebo (an inactive substance, like a sugar pill) to~     determine the relative symptom resolution and health-related quality of life in~     gastroesophageal reflux disease (a disease characterized by a burning sensation (heartburn)~     behind the breast bone caused by a backflow of stomach contents into the esophagus) (GERD)~     patients who fail standard-dose PPI and you will be randomly assigned (similar to flipping a~     coin) to one of the three groups.~   "
230517|NCT00539227|"~     The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an~     alternative procedure to the standard skin-sparing mastectomy for women who have breast~     cancer or are at high-risk for developing breast cancer. You have been asked to take part in~     this study because your treating surgeon feels you are a candidate for skin-sparing~     mastectomy and because you want breast reconstruction after surgery. Outcomes that will be~     measured include how much nipple sensation can be kept after surgery; how satisfied you are~     with how the breast looks after surgery; complication rates; and your quality-of-life.~   "
230518|NCT00539214|"~     -  To compare the effect of pramipexole on depressive symptoms in early and advanced PD~          patients~        -  To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation,~          behavior and mood) and with HADS-D under pramipexole treatment~        -  To investigate whether improvement of depressive symptoms is linked to improvement in~          motor function (UPDRS Part III)~   "
230519|NCT00539201|"~     To determine safety, tolerability and pharmacokinetics of GSK706769~   "
230520|NCT00539188|"~     Self-Injurious Behavior (SIB) is a dangerous and common symptom in Borderline Personality~     Disorder (BPD) patients. Approximately 70% of patients with BPD engage in SIB at some point,~     compared to 17.5% of patients with other personality disorders. While SIB may prompt~     unnecessary psychiatric hospitalizations, it may also cause potential underestimation of the~     lethality of suicidal behavior, thus creating a major and confusing challenge in the practice~     of clinical psychiatry.~      Dialectical Behavioral Therapy (DBT) is a collection of therapeutic techniques focused on~     emotional regulation, impulse control, and improving safety in patients with BPD and others~     with marked self-destructive behavioral tendencies. Though DBT has marked ability to reduce~     BPD symptomatology, including SIB, improvement in SIB is limited and dependent on extensive~     therapy and time.~      Furthermore, the literature on the pharmacological treatment of SIB associated with BPD is~     scarce. Animal studies suggest that SIB may be associated with an imbalance between dopamine~     and glutamate in the brain. Anti-seizure medications that modulate glutamate transmission,~     such as lamotrigine and topiramate, have been suggested to be effective in the treatment of~     SIB in humans.~      Preliminary evidence suggests that antiglutamatergic medications may decrease SIB in patients~     with BPD. Early studies have focused on the antiglutamatergic drug riluzole. More recently,~     we have become interested in the amino acid N-acetylcysteine (NAC), which is used clinically~     for its antioxidant properties and is widely available as a nutritional supplement. Recent~     animal studies have suggested that NAC can modulate glutamate in the central nervous system~     in a way very similar to that proposed for riluzole, and indeed we have observed NAC to have~     an effect similar to riluzole in a case of treatment-refractory obsessive-compulsive~     disorder.~      This study will be a double-blind, randomized, and placebo-controlled evaluation of~     N-Acetylcysteine as an adjunct to DBT in the treatment of SIB associated with BPD. Subjects~     participating in this study will be recruited exclusively from the Dialectical Behavioral~     Therapy program of the Yale-New Haven Hospital, in order to maximize homogeneity of the~     psychotherapeutic care received during their participation.~   "
230521|NCT00539175|"~     1. Objectives:~        1. To assess the efficacy of Photon Stimulation compared with placebo, in treating the pain~          of diabetic neuropathy.~        2. To show that Photonic Stimulation for the treatment of painful diabetic neuropathy is~          cost effective compared to traditional medical interventions. The latter will be~          explored by an extensive search of the literature and from an equal number of patients~          being treated in traditional medical practices using traditional medical interventions.~          At the conclusion of the study the data will be analyzed for cost-benefits and the~          possibility of crafting a best-practices approach to treat these syndromes that cost~          billions of dollars a year in health care expenses and lost productivity.~      2. Research Design~      This is a double blinded, randomized, placebo-controlled study of 120 patients with painful~     diabetic neuropathy. These 120 will be randomly assigned treatments utilizing Photon Therapy,~     using a defined treatment protocol. We expect that some patients will drop out, and our goal~     is 100 treated patients, for statistical purposes. The Photon Therapy group will be split~     into two groups, one group that receives Active Photon Therapy and one group that will be~     treated with the same type of equipment that has been modified to emit no infrared photons~     (Non Active Photon Therapy Group (Placebo)). The patients in the Non Active Photon Therapy~     Group will be offered an Active Photon Treatment Session after completion of the study. The~     patients in the Photon Therapy Groups will be randomized. There will also be an Historical~     Control Group of patients, fifty, will have received traditional medical interventions (e.g.,~     narcotics, seizure medications) in traditional medical practices. Data from these individuals~     will be used to calculate potential cost savings.~      3. Methodology:~      Subjects who meet the inclusion and exclusion criteria and have signed a valid informed~     consent will be eligible to participate in the study. After screening, subjects in the Photon~     Therapy groups (both active and nonactive) will undergo four treatment sessions. The first~     treatment session will vary from the second, third and fourth. During all treatment session,~     each patient will be imaged with the TIP Infrared Camera before, and after treatment.~     Infrared imaging can visualize skin temperature changes in a noninvasive manner (2). The~     first treatment will utilize slightly different protocol than subsequent visits, reduced~     Photon dosage, 120 instead of 240 joules. Proprioception and protective sensation,~     characterized by the Semmes-Weinstein monofilament test, and visual and analog pain scoring~     will also be evaluated before and after each Photon Therapy treatment.~      4. Finding:~      To date, we have just completed 120 patients, using a block randomization scheme not~     previously reported in this field. We have collected data on nerve function, pain, quality of~     life, and skin circulation. The data will remain stored until the study is complete to~     preserve the blinded nature of the project. Data analysis is still incomplete.~      4. Clinical Significance~      Diabetic neuropathy is a chronic and progressive condition that potentially leads to~     disabling pain, and worse, amputation, for many individuals in the United States each year.~     Present treatments utilize antiseizure medications, opiate analgesics, and antidepressants,~     and are inconsistently effective. Development of a new treatment strategy potentially could~     have significant benefit for a great many patients.~   "
230522|NCT00539162|"~     The goal of this clinical research study is to evaluate a method involving a blood test,~     called CA-125, that may be helpful in the early detection of ovarian cancer in women who are~     at low risk.~   "
230523|NCT00539149|"~     This clinical trial was conducted in a population where tympanic membrane perforation occurs~     in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination)~     with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear~     infection throughout childhood. The trial aimed to assess whether twice daily antibiotics~     commencing at first detection of middle ear effusion would cure the infection and/or prevent~     disease progression, compared to placebo.~      The study was conducted in three remote Aboriginal communities in the Northern Territory of~     Australia. The annual birth cohort was 45.~      Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until~     middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent,~     infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to~     24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled~     examinations. At monthly examinations the infant also had a general health check, parents~     were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were~     collected.~   "
230524|NCT00539136|"~     This study will be conducted in healthy volunteers to investigate the absorption of GSK561679~     using Gamma Scintigraphy, PillCam™ SB capsule and the acoustic vest.~   "
230525|NCT00539123|"~     A randomized clinical trial evaluating whether Behavioral Drug and HIV Risk Reduction~     Counseling (BDRC), abstinence-contingent take-home buprenorphine (ACB), or the combination of~     the two improve efficacy and cost-effectiveness of standard buprenorphine treatment for~     opiate-dependent individuals in Malaysia.~   "
230526|NCT00539110|"~     To examine sleep changes following therapeutic drug interventions designed to promote sleep.~   "
230527|NCT00539097|"~     The investigators hope to learn if taking a nutrition drink for a short time after surgery~     for an elective reconstructive burn injury improves donor site healing, muscle mass and scar~     maturation time (the point at which the redness, height and firmness of the wound has faded,~     flattened and softened, and no longer changes in appearance).~   "
230528|NCT00539084|"~     The purpose of this study is to determine whether the MicronJet microneedle device is~     effective for inducing rapid and painless local anesthesia prior to insertions of intravenous~     catheters.~   "
230529|NCT00539071|"~     The purpose of this study is to look at two doses of long-acting injectable risperidone~     (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every~     two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better~     at improving symptoms of schizophrenia or schizoaffective disorder.~   "
230530|NCT00539045|"~     This is a cross-sectional study of post myocardial infarction patients which is designed to~     determine the prevalence of left ventricular thrombi (blood clots) using non-contrast~     echocardiography and to compare this with the prevalence of left ventricular thrombi using~     contrast echocardiography. Secondary aims of this study are (1) to identify clinical and~     imaging correlates of left ventricular thrombi, and (2) to compare quantitative measurements~     of left ventricular chamber size, function, and myocardial mass using contrast and~     non-contrast echocardiography.~   "
230531|NCT00539032|"~     This study will be conducted among children in Saudi Arabia who previously received two doses~     of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal~     vaccine-naïve children (Control Group). This study will evaluate the administration of~     Menactra® in terms of the serum bactericidal antibody it induces in the two study groups.~     Safety of Menactra® vaccine will be described.~   "
230532|NCT00539019|"~     The investigators are collecting information on the calorie needs of patients in the first~     year postburn. The investigators hypothesize that increased energy needs continue for up to a~     year following wound closure from burn injury.~   "
230533|NCT00539006|"~     The purpose of this replicate study to FFU105927 is to provide data on subject preference of~     FFNS as compared with FPNS.~   "
230534|NCT00538993|"~     Hypothesis: HIV clinicians trained to deliver brief counseling messages and receiving cues~     from a brief computer survey on risk behaviors of their patients can counsel have an impact~     on patient's risk behaviors.~   "
230535|NCT00538980|"~     The purpose for conducting this research study is to determine the feasibility of using~     dasatinib as a treatment for polycythemia vera and to determine the optimum treatment~     regimen.~   "
230536|NCT00538967|"~     The matrix metalloproteinase-9 (MMP-9) is considered to play a central role in abdominal~     aortic aneurysm (AAA) initiation. Doxycycline has direct MMP-9 inhibiting properties in~     vitro, and it effectively suppresses AAA development in rodents. Observed inhibition of AAA~     progression, and contradictory findings in human studies evaluating the effect of doxycycline~     therapy on aortic wall MMP-9 suggest that the effects of doxycycline extend beyond MMP-9~     inhibition, and that the effect may be dose dependent.~   "
230537|NCT00538954|"~     Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled~     pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS)~     programmes are perioperative care pathways that address systematically these issues (i.e.~     improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to~     promote a faster recovery and a shorter stay. The key treatments that improve outcome within~     an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to~     assess key outcome variables such as return of GI function. This randomised trial will assess~     the potential synergy between early recovery of GI function (laxation) and early~     postoperative oral nutritional support(with associated preoperative preconditioning using~     carbohydrate/fluid loading). The main overall outcome targets being improved recovery of~     gastrointestinal function, postoperative nutritional status and physical function. It will~     validate the use of a novel, objective technique to measure gastric motility (surrogate for~     GI function). Such refinement of ERAS should result in shorter hospital stay and better use~     of limited health care resource.~   "
230538|NCT00538941|"~     The aim of the present study is to investigate whether in patients with chronic heart failure~     endothelial dysfunction and baroreceptor function is altered by ingestion of a flavonoid-rich~     dark chocolate in comparison to placebo chocolate (Nestlé Placebo Chocolate) on top of~     standard medication.~      Moreover, we will evaluate the effect of chocolate on oxidative stress, platelet adhesion as~     well as systemic inflammatory response such as C-reactive protein and pro-inflammatory~     cytokines in patients with chronic heart failure.~   "
230539|NCT00538928|"~     A prospective, randomized study will be performed investigating the effects of a pumpless~     extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective~     ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a~     PaO2/FiO2 ratio < 200. The duration of ventilation, intensive care and hospital stay and~     in-hospital mortality will be investigated.~   "
230540|NCT00538915|"~     The purpose of this study is to determine if NABI-IGIV (10%) [Immune Globulin Intravenous~     (Human), 10%] is safe and effective in preventing serious bacterial infections (SBIs) in the~     treatment of patients with primary immune deficiency disorders (PIDD) when compared to~     historical control data.~   "
230541|NCT00538902|"~     A study to assess the safety and efficacy of adalimumab administered as a subcutaneous~     injection in adult Chinese subjects with rheumatoid arthritis and treated with methotrexate~   "
230542|NCT00538889|"~     To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to~     healthy subjects.~   "
230557|NCT00538681|"~     This study is intended for patients with advanced, not amenable to surgery, or metastatic~     lung cancer who have not received any prior chemotherapy. The study will be conducted in 2~     parts:~        -  Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin~          combination chemotherapy~        -  Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin +~          enzastaurin versus pemetrexed + cisplatin + placebo. Patients to be included in Part 2~          are those with Nonsquamous NSCLC.~   "
230558|NCT00538668|"~     The purpose of this study is to test the safety of the experimental drug, 177Lu-J591 and see~     what effects (good and bad) it has on your prostate cancer. Another purpose is to find the~     highest dose of the drug that can be given without causing severe side effects.~   "
230543|NCT00538876|"~     This is an open label phase I study designed to explore the feasibility, safety and biologic~     activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin~     induction chemotherapy in younger patients with less-than-favorable risk AML.~      Primary Objective: To find an appropriate dose level for decitabine when used as priming for~     cytarabine and daunorubicin 7+3 induction chemotherapy in AML.~      Secondary Objectives:~        1. To establish the safety and expected toxicities of decitabine when used as priming for~          cytarabine and daunorubicin 7+3 induction chemotherapy in AML.~        2. To establish the optimal dose schedule of decitabine required to broadly demethylate~          cytosine residues in genomic regulatory regions.~        3. To investigate, in selected cases, the molecular and cellular consequences of~          decitabine-induced hypomethylation by a) establishing the extent and degree of~          hypomethylation at specific genomic loci required to reactivate the expression of~          repressed genes and by b) determining the effect of hypomethylation on the~          differentiation and/or apoptosis of leukemic blasts.~   "
230544|NCT00538863|"~     The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for~     the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their~     persistent cancer pain.~   "
230545|NCT00538850|"~     This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the~     clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.~     The study medication is administered under the tongue as a simple spray and can be~     self-administered by patients or assisted by their caregivers. Patients are titrated to an~     effective-dose of fentanyl sublingual spray in the open-label titration period and then~     proceed to the double-blind randomized period where they randomly receive 7 treatments with~     fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a~     total of 6-7 weeks (including both the open-label titration and the double-blind randomized~     periods).~   "
230546|NCT00538824|"~     Study Objectives~        1. To evaluate the efficacy of the combination of dexamethasone (Decadron®), thalidomide~          (Thalomid®), and lenalidomide (Revlimid®) as therapy for patients with relapsed or~          refractory multiple myeloma (MM) who have failed prior treatment with both lenalidomide~          and thalidomide when used as monotherapies.~        2. To evaluate the safety of the combination of lenalidomide, dexamethasone, and~          thalidomide as a therapy for patients with relapsed or refractory multiple myeloma.~   "
230547|NCT00538811|"~     When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic~     antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with~     chronic hepatitis C treated with interferon-alpha. Enhancement of immune responses,~     especially those related to type-1 T helper cell activity, may contribute to better efficacy~     in combining ribavirin with IFN-alpha for treatment of chronic hepatitis C. The aim of the~     present study is to evaluate the efficacy and safety of a triple regimen, a combination~     treatment with Interferon gamma, Interferon alfa-2b plus Ribavirin in patients who have not~     previously responded to interferon alpha in combination of ribavirin.~   "
230548|NCT00538798|"~     The metabotropic glutamate subtype five (mGluR5) receptor is a protein found in the brain and~     is the target for the excitatory chemical messenger glutimate. The purpose of this protocol~     is to measure mGluR5 receptors in the brain using positron emission tomography (PET) and a~     research drug called [18F]SP203.~   "
230549|NCT00538785|"~     The primary goal was to describe the safety of the investigational product when given monthly~     to prevent serious respiratory infection among children with significant heart disease.~   "
230550|NCT00538772|"~     Purpose:~      The purpose of the correlative studies is to evaluate levels of serum factors of circulating~     VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at~     baseline and over the course of initial treatment in order to explore relationships with~     baseline patient factors, measurable disease response and clinical progression.~      Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating~     endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or~     sorafenib.~   "
230551|NCT00538759|"~     The objective of the RADAR trial is to determine the impact of External Beam Radiation~     Therapy (EBRT) on aortic valve restenosis following successful percutaneous balloon aortic~     valvuloplasty (BAV) in elderly patients with severe calcific aortic stenosis.~   "
230552|NCT00538746|"~     Most patients admitted to intensive care units require mechanical ventilation. Weaning from~     assisted/controlled ventilation begins when we recognize that the patient has recovered~     adeguately from acute respiratory failure.~      If weaning is delayed, costs are increased, as are the risks of nosocomial pneumonia,~     cardiac-associated morbility, and death. On the other hand, weaning too soon often results in~     reintubation, which is associated with complications similar to those of prolonged~     ventilation.~      The aim of this trial is to establish an evidence-based approach to weaning and to determine~     when a patient is ready to be weaned from mechanical ventilation, and what is the best~     weaning technique.~   "
230553|NCT00538733|"~     Study Objectives~        1. Evaluate the efficacy of the combination of thalidomide (Thalomid®), clarithromycin~          (Biaxin®), lenalidomide (Revlimid®), and dexamethasone (Decadron®) as an induction~          therapy for patients with newly diagnosed multiple myeloma (MM).~        2. Evaluate the efficacy of the addition of thalidomide (Thalomid®) to BiRD combination~          therapy as a therapy to increase the complete response rate for patients with newly~          diagnosed multiple myeloma.~        3. Evaluate the safety of the combination of clarithromycin, lenalidomide, dexamethasone,~          and thalidomide as a therapy for patients with newly diagnosed MM~   "
230554|NCT00538720|"~     The goal of this clinical research study is to learn how the standard practice of giving~     Vitamin D supplements to patients with a Vitamin D deficiency may affect the size of the~     parathyroid glands in patients with PHPT and a Vitamin D deficiency.~   "
230555|NCT00538707|"~     The aim of the project is to study the acute and chronic effect of mental stress on platelet~     adhesion and aggregation in two population composed of normal subjects at different ages~   "
230556|NCT00538694|"~     To evaluate the safety and efficacy of daptomycin in adults who have pneumonia due to~     Streptococcus pneumoniae.~   "
230635|NCT00537667|"~     The purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI~     with respect to their ability to reduce inflammation and bone and cartilage destruction in~     the synovium of subjects with rheumatoid arthritis.~   "
230559|NCT00538655|"~     Patients treated for methamphetamine dependence have high rates of relapse, and no~     pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d,~     l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent~     that is chemically and pharmacologically dissimilar to CNS stimulants such as the~     amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability~     compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may~     relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to~     reduce cocaine use in dependent users, and is safe when co-administered with intravenous~     methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish~     its safety and efficacy as a pharmacotherapy for methamphetamine dependence.~      Specific Aims:~        1. Determine the safety of modafinil in the treatment of methamphetamine dependence.~        2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence.~        3. Assess the effect of modafinil on cognitive function in methamphetamine users.~        4. Assess the effect of modafinil on methamphetamine withdrawal symptoms.~        5. Compare the validity of a cellular telephone-based reporting system for assessing~          medication regimen adherence to conventional electronic medication monitoring.~      Hypotheses:~        1. Modafinil will be as safe and well tolerated as placebo in a comparison group from~          another study.~        2. Subjects given modafinil will use less methamphetamine than subjects given placebo.~        3. Subjects given modafinil with demonstrate improvements in cognitive function when~          compared to subjects given placebo.~        4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects~          given placebo.~        5. Adherence will be recorded more accurately by cellular telephone than by conventional~          electronic medication monitoring.~   "
230560|NCT00538642|"~     Having a diagnosis of schizophrenia or bipolar disorder and being treated with certain of the~     newer antipsychotics are risk factors for development of diabetes. Subjects with these risk~     factors plus obesity and/or family history of diabetes who agree to study participation will~     undergo an oral glucose tolerance test. If the oral glucose tolerance test demonstrates that~     the subject is pre-diabetic (elevated glucose levels, but below the diabetic range), he/she~     will have his/her insulin resistance level measured, prior to random assignment to either~     stay on current antipsychotic medication or switch to ziprasidone. Insulin resistance will be~     measured again after four months. The primary hypothesis is that insulin resistance will~     decrease in those switched to ziprasidone relative to those continuing on their same~     antipsychotic medication.~   "
230561|NCT00538629|"~     Investigation of the impact of Zeldox on metabolic parameters in patients with bipolar~     disorder or with schizophrenia and the impact of the treatment with quality of life.~   "
230562|NCT00538616|"~     The purpose of this study is to evaluate brain injury when two different drugs (propofol and~     precedex) are used to sedate patients who need a neurologic exam.~   "
230563|NCT00538603|"~     Multi-national, randomized, phase III, GCIG Intergroup study comparing pegylated liposomal~     Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in patients with~     epithelial ovarian cancer in late relapse. (CALYPSO)~   "
230564|NCT00538590|"~     To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation~     and Mitomycin-C(MMC) in glaucoma surgery.~   "
230565|NCT00538577|"~     Soft tissue necrotizing fasciitis of limbs are lethal infections and associated with high~     morbidity and mortality rates. The purpose of this study is to determine the clinical~     manifestations and factors affected the treatment outcome to predict the prognosis and make~     timely decision for appropriate management and prevent limb loss.~   "
230566|NCT00538564|"~     This research is being done to compare the effect of tadalafil with placebo (an inactive~     substance that looks like the study drug, but should have no effect) on the frequency of~     recurrent priapism (prolonged erection, unassociated with sexual interest or desire) and the~     nature of sexual experiences in male patients with sickle cell disease.~   "
230567|NCT00538551|"~     Prospective Data Collection of Newly Diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma~     Cases~   "
230568|NCT00538538|"~     Visual outcomes of the eye with large subretinal hemorrhages (bleeding under the retina) due~     to Age-Related Macular Degeneration (AMD) are poor. The Submacular Surgery Trial (SST) showed~     that no statistically significant improvement in vision resulted from surgical removal of the~     layer of abnormal blood vessels causing the bleeding. However, placement of a gas bubble into~     the gel of the eye along with removal of the blood has shown some success. However, this does~     not treat the underlying condition of the AMD.~      Intravitreal injections (into the gel of the eye) of a drug called Lucentis has been shown to~     be highly effective in the treatment of AMD, yet its penetration through areas of thick blood~     caused by subretinal hemorrhage is not known.~      This study is proposing to treat the AMD causing the subretinal hemorrhage with a vitrectomy~     (surgery involving removing the gel inside the eye, and membrane layers of the eye) followed~     by Lucentis placed between the layers of the retina and then with or without a gas bubble.~      In order to determine if the the subretinal Lucentis alone is beneficial, 5 of the 10~     patients enrolled will get a gas bubble and the other 5 will not.~   "
230569|NCT00538525|"~     Phase II study of neoadjuvant chemotherapy with Doxorubicin followed by Docetaxel-Cisplatin~     in locally advanced breast cancer~   "
230570|NCT00538512|"~     The purpose of this study is to evaluate the absolute (versus placebo) and relative (one~     vaccine compared to the other) efficacies of the live attenuated and inactivated influenza~     vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating~     strains whether similar or dissimilar to strains included in the vaccines.~   "
230571|NCT00538499|"~     RATIONALE: Patient-controlled analgesia using fentanyl and bupivacaine may lessen pain caused~     by video-assisted chest surgery. Giving bupivacaine in different ways may give better pain~     relief.~      PURPOSE: Thisrandomized clinical trial is comparing three different ways to give bupivacaine~     together with fentanyl to see how well they work in reducing pain after video-assisted chest~     surgery.~   "
230572|NCT00538486|"~     The epidemic of obesity is associated with a considerable rise in the incidence of the~     metabolic syndrome, type 2 diabetes mellitus, and hypertension. Insulin resistance plays an~     important role in the pathogenesis of obesity related hypertension. These patients are at~     high risk to suffer from cardiovascular events. However, current guidelines for treatment of~     hypertension do not provide specific recommendation for the pharmacotherapy of obese~     hypertensive patients due to lack of prospective randomized intervention studies in~     non-diabetic obese hypertensive patients.~      Aside from their antihypertensive effects, angiotensin II receptor blockers (ARB) were shown~     to improve insulin sensitivity. Furthermore, metformin is commonly used to treat the obese~     type 2 diabetes mellitus. Metformin can also lower body weight and increase insulin~     sensitivity. In a prospective, double-blind, double-dummy, randomized, parallel-group study,~     we will evaluate the effects of ARB (telmisartan and candesartan) or amlodipine combination~     with metformin on weight gain, visceral fat, and metabolic parameters in obese hypertensive~     patients without diabetes mellitus compared with obese hypertensives on ARB or amlodipine~     treatment alone. This study will help to develop future comprehensive treatment strategies~     and guidelines for obesity related hypertension.~   "
230573|NCT00538473|"~     Since influenza vaccines are administered every year because of the frequent change in their~     antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza~     vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study,~     the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008~     season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in~     study 107973 (NCT00386113) are eligible for participation in this study.~   "
230574|NCT00538460|"~     This study is designed to evaluate the effectiveness and measurable cost impact of stress~     cardiac MRI for non-invasive evaluation of intermediate lesions discovered on CCTA in~     low-to-intermediate risk patients admitted to the ED with suspected ACS. Our primary~     objective is to determine if the strategy of CTA + stress CMR will reduce the length of time~     in the ED required to establish a definitive diagnosis, compared to CTA + stress MPI.~   "
230575|NCT00538447|"~     Prospective Database for Chronic Myelogenous Leukemia~   "
230576|NCT00538434|"~     This trial will study three doses of reslizumab versus placebo in children with eosinophilic~     esophagitis (EE). The objectives of the trial will be to study the effectiveness of~     reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils~     as well as assessing the safety profile compared to placebo.~   "
230577|NCT00538421|"~     Comparing 2 different anaesthetic methods during abdominal aortic aneurysm surgery. The~     patients will be followed up 30 days postoperative. Number of patients included will be 200.~     Perioperative details will be analyzed.~   "
230578|NCT00538408|"~     To investigate the diagnostic performance of whole body magnetic resonance angiography~     (WB-MRA) using two different magnetic resonance contrast agents.~   "
230579|NCT00538395|"~     Intensive sequential chemotherapy with Adriamycin Taxol and Cytoxan in the treatment of~     locally advanced breast cancer~   "
230580|NCT00538382|"~     The objective of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD)~     of a standard dose of orally administered artesunate, in order to determine if the current~     adult dose (200 mg) is appropriate in parasitemic pregnant women when compared to the same~     women at three months postpartum and to parasitemic non-pregnant women. Preliminary evidence~     on safety, tolerability and efficacy will be gathered.~   "
230581|NCT00538369|"~     When a physiologic tool to measure the patient's hypnotic state is added to current practice~     tools is there a decrease in the amount of drug the patient receives.~   "
230582|NCT00538356|"~     Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct~     trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate~     variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK~     active implants has the potential to detect some of these trends early and thus to offer the~     possibility to intervene in time for prevention of fatal worsening of heart failure.~      To investigate the predictive value of Home Monitoring parameters, patients with symptomatic~     heart failure and reduced ejection fraction receiving an implantable~     cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization~     therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring~     analysis or standard care. The influence of Home Monitoring on the clinical status of heart~     failure patients will be assessed.~   "
230583|NCT00538343|"~     The purpose of this study is to determine whether RTA 744 is effective in the treatment of~     breast cancer that has metastasized to the brain.~   "
230584|NCT00538330|"~     Post operative adjuvant chemotherapy followed by adjuvant Tamoxifen vs nil for patients with~     operable breast cancer~   "
230585|NCT00538317|"~     In patients with acute myocardial infarction who are managed in the prehospital setting, and~     who will treated with primary angioplasty, we evaluate the benefit of an early administration~     of tirofiban, a powerful GPIIbIIIa inhibitors. Patients are randomised to early~     administration in the ambulance or administration in the cathlab. The primary endpoint is~     TIMI 2-3 flow in the first coronary opacification of the culprit artery.~   "
230586|NCT00538304|"~     A one month study which will determine the safety and efficacy of bimatoprost eye drops in~     patients with glaucoma or ocular hypertension~   "
230587|NCT00538291|"~     RATIONALE: Monoclonal antibodies such as cetuximab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of~     colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as~     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving cetuximab together with capecitabine may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine~     work in treating patients with metastatic colorectal cancer.~   "
230588|NCT00538278|"~     Prospective Database for Acute Myeloblastic Leukemia~   "
230589|NCT00538265|"~     An open-label randomized multicenter clinical study comparing three regimes of~     immunosuppression : (A) tacrolimus and steroids, (B) antithymocyte induction therapy and full~     dose of tacrolimus, (C) antithymocyte induction therapy with mycophenolate mofetil and a~     reduced dose of tacrolimus.~   "
230590|NCT00538252|"~     Parental involvement has been shown to be a robust predictor of child conduct problems (CP)~     and drug use risk in childhood and adolescence, but relatively little attention has been paid~     to the role of parental involvement in relation to child problem behavior during the~     transition to school-age, when children are spending more time in school, after-care~     settings, and in the neighborhood. Concomitantly, as children transition from preschool to~     school-age, there is evidence to suggest that the quality and organization of schools,~     after-school care, and neighborhoods play an increasingly important role in the emergence of~     children's CP and drug use risk. Specifically, we will address: 1) the extent to which the~     quality of school environments, after-school care, and neighborhoods are associated with the~     emergence of CP during the early school-age period; 2) how parental involvement in the~     toddler and preschool period may be associated with parental involvement and monitoring in~     extra-familial contexts in the early school-age years; 3) how parental involvement in~     schools, after-care, and the neighborhood, may moderate relationships between extra-familial~     factors and children's CP; and 4) whether a parenting intervention can increase parental~     involvement in school, after-care, and neighborhood contexts and decrease risk of children's~     subsequent CP. These issues will be tested with an existing sample of 731 ethnically-diverse~     children from urban, suburban, and rural sites. As all families in the study were recruited~     based on the presence of sociodemographic, family, and child risk factors, the cohort of~     children are at high risk for displaying a persistent trajectory of clinically-meaningful CP~     and drug use risk. Thus, the study has the potential to fill a much-needed void on~     associations between extra-familial contexts and risk for early-starting CP and later problem~     behavior during the early school-age years. Equally critical, the study can provide data on~     the potential moderating influence of involved parenting, its malleability for families~     facing multiple adversities, and whether family-based interventions can make a difference for~     children facing multiple adversities.~   "
230591|NCT00538239|"~     The purpose of this study is to determine whether maintenance therapy with oral AP23573~     (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in~     patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result~     in clinically significant improvement in progression-free survival as compared to oral~     placebo.~   "
230592|NCT00538226|"~     This is an open label pilot study to evaluate the efficacy and the safety of the Flowaid~     device in increasing local circulation in the legs.~      15 patients with a diagnosis of Peripheral Vascular Disease will be enrolled in this study.~     They will recieve tratment with the Flowaid device and monitored continuously by means of~     Laser Doppler Flowmetry as well as by tcPO2 and Digital Thermography. Subjective data will~     also be collected.~   "
230593|NCT00538213|"~     Since influenza vaccines are administered every year because of the frequent change in their~     antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza~     vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study,~     the subjects previously enrolled in study 104887 will receive a dose with the 2007-2008~     season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in~     study 104887 are eligible for participation in this study.~   "
230594|NCT00538200|"~     The purpose of this study is to determine the best form of dietary intervention to~     undernourished individuals with COPD.~      The research aims to test the null hypothesis that there is no difference between oral~     nutritional supplements and dietary advice.~   "
230595|NCT00538187|"~     Obatoclax may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer.~     Bortezomib and obatoclax may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells.~     This phase I/II trial is studying the side effects and best dose of obatoclax when given~     together with bortezomib and to see how well they work in treating patients with aggressive~     relapsed or recurrent non-Hodgkin lymphoma.~   "
230596|NCT00538174|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin~     in diabetic Japanese subjects administered for 14 days~   "
230597|NCT00538161|"~     We propose that as low tidal volume ventilation has proven to be beneficial in patients with~     established ARDS it may have a role in preventing the onset of acute lung injury in the~     cardiac surgical population. Institution of low tidal volume ventilation in the operating~     room may reduce the release of the cytokines and interleukins that have been known to~     contribute to the development of acute lung injury. In this study, we propose that the~     institution of low tidal volume ventilation in the operating room will reduce the incidence~     of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours~     post operatively will help determine if there is a difference in oxygenation between the two~     groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine~     if there is a role for low tidal volume ventilation in the operating room. We will also~     attempt to establish a causative mechanism by measuring plasma levels of cytokines known to~     be associated with the development of ARDS.~   "
230598|NCT00538148|"~     Non-inferiority efficacy of telithromycin versus azithromycin~   "
230599|NCT00538135|"~     The aim of the study was to investigate if the addition of cognitive behavioural therapy to~     treatment as usual (CBT plus TAU) in participants with borderline personality disorder would~     decrease the number of participants with emergency (i.e. unplanned) psychiatric or accident~     and emergency room contact or episode of deliberate self-harm over twelve months treatment~     and twelve months follow-up, compared with treatment as usual (TAU). The study also examined~     whether CBT plus TAU would lead to superior improvement in quality of life, social, cognitive~     and mental health functioning than TAU alone.~   "
230600|NCT00538122|"~     This study is being done to look at the electrical activity of the heart. This study will~     help decide whether taking recordings for a 24-hour period gives more useful information than~     recording it for a few seconds in a doctor's office. The study will compare 24 hour~     electrocardiogram (ECG) results of patients taking thioridazine (Mellaril) to those of other~     patients taking different medications that took part in another study.~   "
230601|NCT00538109|"~     An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients with~     Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast~     Crisis, Accelerated Phase or Chronic Phase~   "
230602|NCT00538096|"~     -  Evaluate the safety and tolerability of multiple doses of MEDI-538 by continuous IV~          infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative~          therapy.~        -  Determine the maximum tolerated dose of MEDI-538 administered by continuous IV infusion.~   "
230603|NCT00538083|"~     Cardiovascular disease is the leading cause of death in the United States. Studies have shown~     that obesity is an important risk factor for development of cardiovascular disease.~     Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of~     cardiovascular disease. Recent research findings indicate that consumption of cocoa exerts~     cardioprotective effects, which include increasing HDL levels, reduction in systolic BP,~     inhibition of platelet aggregation/activity and activation of endothelial nitric oxide~     synthase.~      Proposed is a randomized controlled trial consisting of 4 phases designed to examine the~     dose-response, and the acute and sustained effects of cocoa consumption on endothelial~     function as a marker of cardiovascular disease risk in 45 otherwise healthy adults with a BMI~     25-35kg/m2.~   "
230615|NCT00537927|"~     Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might~     influence the degree of postoperative pain.~      The study hypothesis is that there is no difference in postoperative pain between different~     methods to fix the mesh in laparoscopic incisional / ventral hernia repair.~   "
230616|NCT00537914|"~     This study is performed to investigate the long-term safety, in particular the diabetogenic~     potential and immunogenicity of rhGH therapy in short children born small for gestational age~     (SGA).~   "
230617|NCT00537901|"~     First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum~   "
230633|NCT00537693|"~     This pilot study will compare the effect of diffusive versus convective Continuous Renal~     Replacement Therapy (CRRT) in children with sepsis who require CRRT.~      The hypothesis for the study is that convective forms of CRRT provide enhanced clearance of~     cytokines and improved clinical responses as compared to a diffusive CRRT modality.~   "
230604|NCT00538070|"~     The NMDA receptor has been identified as having a role in substance use disorders as well as~     in schizophrenia. One example of the former is nicotine's effect on dopaminergic activity not~     only by increasing the release of dopamine in the Midbrain reward centers, but also through~     less direct mechanisms affecting alpha-7 nicotinic receptors, NMDA receptors, and Glycine, a~     co-agonist for the NMDA receptors. In terms of schizophrenia, it has been hypothesized that~     NMDA receptor hypofunction plays a role in the mechanism for negative symptoms and cognitive~     dysfunction in these patients. The NMDA hypofunction may be reversed with increased synaptic~     glycine availability.~      Sarcosine, or n-methyl-glycine, is a GlyT-1 and System A transport inhibitor actions which~     could be expected to increase the availability of glycine, in the synaptic space. Sarcosine~     is a dietary supplement which could be found in several food items such as egg yolks and~     turkey.~      Our collaborative team has developed a novel, non-invasive magnetic resonance spectroscopy~     (MRS) technique for measuring brain glycine changes that allows us to study glycine~     homeostasis. The purpose of this study is to explore the effect of sarcosine~     (n-methyl-glycine) on brain glycine concentrations. It is our hypothesis that oral sarcosine,~     at a dose of 2 grams per day, will be well tolerated and associated with increased brain~     glycine concentrations. It is our secondary exploratory hypothesis that increases in brain~     glycine will be associated with behavioral signs of increased NMDA and dopamine activity.~     This modulation could have future therapeutic potential for disorders of hedonic and~     cognitive function.~   "
230605|NCT00538057|"~     A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is~     being developed for once daily administration for the maintenance treatment of asthma and~     COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and~     compared with GW642444M and GW685698X administered separately in order to determine whether~     co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics~     of either compound.~   "
230606|NCT00538044|"~     we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to~     congenital heart disease or chronic pulmonary embolism before and after the operation.~   "
230607|NCT00538031|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving cyclophosphamide together with celecoxib may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide together~     with celecoxib works compared to cyclophosphamide alone in treating patients with recurrent~     or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer.~   "
230608|NCT00538018|"~     Demonstrate efficacy of telithromycin over single-agent oral antibiotics usually prescribed~     by local guidelines (usual care) for treating adult outpatients with mild to moderate~     community-acquired pneumonia (CAP) in high bacterial resistance areas.~   "
230609|NCT00538005|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of malignant melanoma by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving sorafenib together with~     bevacizumab and oxaliplatin may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side-effects and best dose of sorafenib when~     given together with bevacizumab and oxaliplatin and to see how well it works in treating~     patients with metastatic malignant melanoma.~   "
230610|NCT00537992|"~     Although commonly used in cataract surgery, the use of the blue light-filter IOLs in~     vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled~     clinical trial was designed to evaluate the effect of the blue light-filter IOL on the~     surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.~   "
230611|NCT00537979|"~     Prospective, non-randomized, multi-center study to assess the efficacy and safety of~     paricalcitol injection or oral administered over 6 months to patients with secondary~     hyperparathyroidism on dialysis.~   "
230612|NCT00537966|"~     Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of~     early antiretroviral treatment and investigate early events of virus-host interactions in~     patients with documented acute or recent HIV-1 infection in Zurich.~      Study design: This is an open label, non-randomized, observational, single center study at~     the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We~     aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill~     the inclusion criteria of a documented acute or recent HIV infection can participate in the~     study. Patients are offered early combination antiretroviral treatment (cART), if treatment~     start falls within 90 days after diagnosis of acute HIV-infection. After one year of~     suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who~     have not chosen to undergo early-cART, respectively will stop cART after one year will be~     followed for a total of 5 years. Viral setpoints reached after treatment interruptions will~     be compared to historic controls and to the control group not having received cART during~     acute infection. A battery of virological and immunological assays will be performed on blood~     samples obtained to better understand early virus-host interactions, which are thought to~     play a key role in HIV-pathogenesis research.~      Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection~     with regard to epidemiology, impact of early-cART on the course of disease and forms the base~     for a variety of translational research projects addressing early key pathogenesis events~     between virus and host, relevant for the course of disease, for transmission, for development~     of vaccines and new treatment strategies.~        -  Trial with medicinal product~   "
230613|NCT00537953|"~     The combination of a half-course of miltefosine and a half-course of antimony will be~     evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen~     because these are now the two standard agents in Bolivia, and in vitro the combination was~     additive to mildly synergistic against a standard leishmania strain.~   "
230614|NCT00537940|"~     To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with~     partial seizures.~   "
230618|NCT00537888|"~     The definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp.~     form sputum twice or three times a week has been regarded as the microbiological evidence of~     pulmonary candidiasis. The investigators hypothesize that patients who present respiratory~     symptoms and lung infiltrates together with smear of culture positive for candida spp. from~     sputum three times a week can not be diagnosed as pulmonary candidiasis.~   "
230619|NCT00537875|"~     The purpose of this study is to determine whether powdered ginger root (encapsulated ginger)~     is effective for reducing the frequency, duration and severity of both acute and delayed~     nausea and vomiting.~   "
230620|NCT00537862|"~     This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium~     (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney~     transplant recipients~   "
230621|NCT00537849|"~     An investigational study on the use of HIFU in the management of localized prostate cancer as~     a primary non-comparative study~      High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that~     uses intersecting, precision focused ultrasound waves to raise the temperature of the target~     to )80-90 degrees C in 2-3 seconds, destroying the targeted tissues (prostate cancer). The~     tissue targeting is highly precise, minimizing collateral damage.~      The overall hypothesis is that HIFU with Sonablate can safely, effectively and selectively~     ablate prostate cancer tissue, resulting in complete tissue necrosis, in patients diagnosed~     with localized T1c/T2a prostate cancer, with minimal morbidity.~      The specific hypothesis is that the Sonablate has the ability to:~        -  COmpletely destroy prostate cancer tissue, without causing damage to the intervening~          tissue, with a drop in PSA levels to <0.5ng/ml.~        -  Result in negative biopsies for evidence of viable malignant cells after the~          treatment(12 months if Nadir is not reached or PSA rises from Nadir)~        -  Safely treat localized prostate cancer pts., with minimal and acceptable adverse~          effects.~   "
230622|NCT00537836|"~     The primary goal of the planned study is to investigate the efficacy and safety of ZK 283197~     in the dosage of 2 and 3 mg ingested once daily during a period of 8 weeks for the treatment~     of hot flushes. In order to be able to assess the efficacy of the test substance, this is~     compared with the efficacy of 1 mg Estradiol and placebo. The comparator Estradiol is a~     certified hormone preparation, which is already used for the treatment of hot flushes as~     standard treatment. After passing the screening, volunteers will start with a run-in phase~     followed by a 8 weeks treatment and a follow-up phase. 112 postmenopausal women with hot~     flushes and without relevant prior diseases will participate in three European countries (2~     study sites in Germany, 1 study site in Great Britain and 1 study site in The Netherlands) in~     this study.~   "
230623|NCT00537823|"~     The purpose of this study is to determine the effect of short-duration pre-operative FOLFOX~     based therapy on postoperative problems after liver surgery for patients with metastatic~     colorectal cancer.~   "
230624|NCT00537810|"~     This study will test the effectiveness of two empirically-supported but distinct treatments~     for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure~     self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy~     for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered~     alone and in combination in a primary care setting.~   "
230625|NCT00537797|"~     The main purpose of this study is to see how well FDG-PET scans can determine the malignancy~     of thyroid nodules that have already been tested (and come back positive) by fine needle~     aspiration.~   "
230626|NCT00537784|"~     People operated for a rupture of the Achilles tendon receive a concentrate of their own~     platelets injected into the operated area. The study is randomized and single-blinded, with~     20 treated patients and 20 controls, who get no injection. The primary endpoint is a~     mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a~     special type of radiography. This radiography uses 0.8 mm metal markers, which are injected~     into the tendon. The tendon is mechanically loaded during radiography and its strain can be~     measured as increased distance between the markers. Other mechanical variables at 6, 12 and~     52 weeks are secondary variables, as well as a validated patient-administrated questionaire~     at 1 year.~   "
230627|NCT00537771|"~     The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20~     mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.~      The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20~     mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test,~     and time to treatment failure.~   "
230628|NCT00537758|"~     This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL)~     treatments for obese patients with binge eating disorder (BED). The study involves a~     comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part)~     treatment consisting of CBT followed by BWL.~   "
230629|NCT00537745|"~     The purpose of this study is to determine whether Vivitrol is effective at reducing attempts~     to drive after drinking among repeat driving while intoxicated (DWI) offenders with Ignition~     Interlock devices.~   "
230630|NCT00537732|"~     Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a~     standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing~     (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The~     individual elimination capacity is genetically controlled and therefore all patients will be~     genotyped prior to therapy.~   "
230631|NCT00537719|"~     This study will use scintigraphy techniques to measure gastric emptying rate of liquid and~     solid food at baseline and after administration of GSK716155 or placebo.~   "
230632|NCT00537706|"~     This study will identify what programs, along with traditional healthcare, low-income urban~     residents would choose to improve their health. The information is intended as a step toward~     designing public policies aimed at improving the health of low-income populations in the~     United States.~      Residents of Washington, D.C., who are between 18 and 64 years of age and are in a specified~     income bracket may be eligible for this study.~      Participants take part in audio-taped group discussions led by a trained facilitator. During~     a 3 hour session, participants engage in 4 cycles of choosing benefits. Participants select~     benefits as follows:~        -  For themselves individually.~        -  For their neighborhood.~        -  For an entire city.~        -  Once again individually.~   "
230636|NCT00537654|"~     This study will be an open-label, randomized, single dose, three way partial crossover study~     in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose~     combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram~     [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin~     hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy~     adult male subjects will be enrolled into the study. Subjects will receive single oral doses~     in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC,~     ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available~     tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose~     combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4~     mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin~     hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination~     formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg~     tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a~     minimum 28 day washout period. The total duration of a subject's involvement in this study is~     approximately 15-18 weeks.~   "
230637|NCT00537641|"~     This study will test the hypothesis that noninvasive ventilation (NIV) as prescribed in~     current medical practice for use in amyotrophic Lateral Sclerosis (ALS) patients fails to~     deliver adequate breathing support over a night of use in the patient's home. ALS patients~     who come to the ALS Center for their routine 3 month follow up exam and are currently using~     NIV will be asked to complete questionnaires regarding their quality of sleep, quality of~     life and general level of function, and to undergo a home sleep study, using a safe,~     comfortable and reliable breathing monitoring system during a night of sleep. If the~     questionnaires or the sleep study show failure of the breathing device, the investigators~     will work with the patient to fix the problem and then offer a second study to make sure that~     the changes were helpful. The results of this study may help to develop subsequent studies~     and to improve the guidelines used for care of ALS patients.~   "
230638|NCT00537628|"~     Primary Objectives~        1. Mid Region pro Adrenomedullin (MR-proADM) is superior to BNP for the prognosis of heart~          failure (HF) patients and adds incremental value in predicting outcomes for patients~          presenting to the Emergency Department (ED) with shortness of breath.~        2. Mid Region pro A-Type Natriuretic Peptide (MR-proANP) is non-inferior to BNP for the~          diagnosis of HF in patients presenting to the ED with shortness of breath.~   "
230639|NCT00537615|"~     The purpose of this study is to investigate the absorption, metabolism and excretion of [14C]~     PD 0332334 to characterize plasma, fecal and urinary radioactivity and identify any~     metabolites of [14C] PD 0332334.~   "
230640|NCT00537602|"~     Cystic fibrosis is a genetic disease caused by mutation of the cystic fibrosis transmembrane~     conductance regulator (CFTR). The purpose of the study is to investigate the effects of~     miglustat on CFTR function in cystic fibrosis patients.~   "
230641|NCT00537589|"~     Does ultrasound guidance improve success rate and decrease aspiration attempts for peripheral~     arthrocentesis?~   "
230642|NCT00537576|"~     The purpose of this study is to evaluate the safety, tolerability and acceptability of a new~     formulation of Lactobacillus crispatus, strain CTV-05 (LACTIN-V) in healthy pre-menopausal~     women. Osel, Inc. proposes that this new formulation will be safe and well-tolerated in~     healthy pre-menopausal women.~   "
230643|NCT00537563|"~     Clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure~     visit, and to assess the safety of telithromycin given once daily for 5 days vs moxifloxacin~     given once daily for 10 days in the treatment of subjects with AMS.~   "
230644|NCT00537550|"~     The present study has been designed to give participating centers the possibility of better~     understanding the diagnostic and prognostic factors of ALL patients.~   "
230645|NCT00537537|"~     This study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in~     non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Antiviral efficacy~     is assessed by hepatitis B virus (HBV) DNA non-detectability (PCR <300 copies/ml) by week 104~     with CHB.~   "
230646|NCT00537524|"~     Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months~     to 17 years compared to seasonal flu vaccination~   "
230647|NCT00537511|"~     The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047~     (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive~     disease small cell lung cancer.~   "
230648|NCT00537498|"~     The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000~     000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in~     patients with diabetic foot syndrome.~   "
230649|NCT00537485|"~     To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a~     multi-center, placebo-controlled, double-blind study following once-daily multiple~     transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose~     titration/maintenance period)~   "
230650|NCT00537472|"~     This study plans to investigate whether a reduced dose of bupivacaine (a local anesthetic~     numbing drug) injected into the spinal space for a total knee replacement will result in a~     shorter time to discharge from the recovery room while maintaining adequate surgical~     anesthesia.~   "
230651|NCT00537459|"~     16448 is being investigated for the treatment of primary premature ejaculation (PE) using a~     novel mode of action. There are no approved therapies for premature ejaculation, and novel~     therapies are needed for this syndrome.~      16448 has been shown to increase ejaculatory latency in the PCA rat model of premature~     ejaculation.~      A novel instrument, the Sexual Assessment Monitor (SAM), will be used to measure ejaculatory~     latency time in this study. This device, which measures ELT under standard conditions, has~     been shown to provide a more reliable measure of ejaculatory latency compared to the use of a~     stopwatch during sexual intercourse~   "
230664|NCT00537290|"~     RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a~     medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody~     (aPL) -related certain clinical problems.~   "
230665|NCT00537277|"~     This trial is conducted in Europe.~      This is a clinical trial investigating the effectiveness and the safety of using biphasic~     insulin aspart 30 both for initiation and intensification of insulin treatment in type 2~     diabetes.~   "
230652|NCT00537446|"~     Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig's Disease, is a fatal disorder that~     causes progressive degeneration and weakening of the muscles of breathing, leading to~     breathing insufficiency and eventually breathing failure. This breathing insufficiency is~     commonly treated with a breathing assistance device, known as noninvasive positive pressure~     ventilation (NIPPV). While generally well tolerated and accepted, it is not clear whether or~     to what extent NIPPV in fact helps breathing function: some data suggest that NIPPV preserves~     breathing function over time, whereas other data suggest that it actually causes breathing~     function to decline more quickly. No studies have shown what the acute effect of NIPPV is on~     breathing muscle function in ALS patients.~      This study will test the hypothesis that the acute use of NIPPV, at pressure levels that are~     in common clinical use, will cause measurable changes in tests of breathing function,~     compared to baseline and to lower levels of NIPPV. We expect that the results of this study~     will help to clarify whether and to what extent NIPPV assists respiratory muscle function in~     patients with ALS.~   "
230653|NCT00537433|"~     Liquid medication administration errors are common, and place children at risk for adverse~     events. Caregivers with low socioeconomic status (SES), low education and poor health~     literacy skills are at increased risk for errors. In this study, we seek to assess whether~     at-risk parents who received a plain language, pictogram-based intervention would have~     reduced medication dosing errors and improved medication adherence.~   "
230654|NCT00537420|"~     The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24~     weeks of treatment.~   "
230655|NCT00537407|"~     Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action~     demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and~     patients.~      The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha~     and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated. Only~     40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study~     assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin~     can improve the outcome of treatment in this group of patients.~   "
230656|NCT00537394|"~     The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV~     requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a~     problem for many treatment-experienced, HIV-infected people. The purpose of this study was to~     determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new~     anti-HIV drug regimen for the suppression of HIV.~   "
230657|NCT00537381|"~     The purpose of this study is to assess the effects of intetumumab when given in combination~     with docetaxel and prednisone to participants with metastatic (spread of cancer cells from~     one part of the body to another) hormone-refractory (not responding to treatment) prostate~     cancer (abnormal tissue that grows and spreads in the body until it kills).~   "
230658|NCT00537368|"~     The purpose of this study is to determine if CNTO 888 is safe and to determine how long CNTO~     888 stays in the body and what effects it might have on cancer tumors.~   "
230659|NCT00537355|"~     This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter~     study. After passing the initial Screening Visit, subjects will be in the environmental~     exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each~     day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total~     Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo~     treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the~     study drug. About three weeks after the last injection, subjects will be asked to be in the~     EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after~     Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits~     13-16, Days 82-85).~      During all EEC visits, the subjects will be exposed to ragweed pollen at an average~     concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours.~     During each EEC visit, patients will be asked to record symptom scores for nasal and~     non-nasal symptoms at scheduled time points.~      The total duration of a subject's participation in this study is expected to be a minimum of~     85 days.~   "
230660|NCT00537342|"~     The objective of this trial is to evaluate the clinical effectiveness of the administration~     of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or~     allergic rhinoconjunctivitis~   "
230661|NCT00537329|"~     The purpose of this study is to determine whether or not the Investigational Study Drug~     anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in~     Asian subjects.~   "
230662|NCT00537316|"~     Part 1 of this study is a 3-arm, randomized, active-controlled, parallel-group, multicenter,~     double-blind, double-dummy, 16-week study to compare the efficacy and safety of infliximab~     (IFX), as monotherapy or in combination with azathioprine (AZA) versus AZA monotherapy in~     adults with moderate to severe active ulcerative colitis (UC). Participants who qualify at~     the Baseline Visit will be eligible to be randomized to one of the three active treatment~     groups.~      Participants in the IFX/AZA combination therapy and IFX monotherapy cohorts will receive IFX~     infusions at Weeks 0, 2, and 6 and daily oral AZA/placebo, respectively; participants in the~     AZA cohort will receive daily oral AZA and placebo infusions at Weeks 0, 2, and 6. At Week 8,~     all participants will be evaluated for response.~      Participants responding to IFX treatment at Week 8, either as monotherapy or in combination~     with AZA, will receive one more IFX infusion at Week 14; non-responders to IFX therapy will~     receive placebo infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14.~      Participants responding to AZA monotherapy at Week 8 will continue on AZA therapy and receive~     one placebo infusion at Week 14; nonresponders to AZA will be eligible to receive IFX at~     Weeks 8, 10, and 14.~      Part 2: Participants in remission on IFX monotherapy or IFX/AZA treatment at Week 16 will be~     randomized to either maintenance or intermittent open-label IFX treatment; randomization will~     be stratified based on oral AZA/placebo treatment in Part 1. Oral AZA/placebo treatment will~     continue to be double-blinded. All participants will continue to receive oral AZA/ placebo~     for the duration of the study.~      Participants randomized to maintenance IFX treatment will receive scheduled IFX infusions~     every 8 weeks beginning at Week 22 (Week 6 for direct entry). If participants lose response,~     or if treatment has to be discontinued because of an adverse event, these participants are~     considered treatment failures, and should be followed up for safety at the scheduled 6-month~     visits (Weeks 38, 62, and 94 [Weeks 22, 46, and 78 for direct entry]). These participants~     will receive standard of care per their personal physician.~      Participants randomized to intermittent IFX treatment will be evaluated every 8 weeks.~     Participants will receive IFX only upon relapse of disease. Treatment with IFX will be~     initiated at Weeks 0, 2, and 6 of the individual treatment cycle and will continue every 8~     weeks until remission is regained. Throughout the study, individual treatment cycles will be~     repeated whenever a subject relapses.~      In addition, to facilitate enrollment into Part 2, participants who received treatment~     outside of Part 1 and who are in remission on IFX with or without AZA/6-mercaptopurine (6-MP)~     will be allowed to enter directly into Part 2. In the Czech Republic, direct entry into Part~     2 of the study is not allowed.~      A higher than expected incidence of serious infusion reactions observed in the intermittent~     treatment arm of another study (Protocol P04563, NCT0358670) conducted in participants with~     moderate to severe psoriasis resulted in the termination of that study. Based on the~     similarities in study design between the intermittent treatment arm of P04563 and the~     intermittent treatment arm of Part 2 of this study, enrollment to Part 2 of this study was~     put on hold, for precautionary reasons. At the same time, all participants already enrolled~     in the intermittent treatment arm of Part 2 were asked to discontinue from the trial. In~     October 2009, a decision was made by the sponsor to terminate the whole study (Part 1 and 2).~     At that time, participants enrolled in Part 1 of the study were allowed to complete their~     treatment up to Week 16.~   "
230663|NCT00537303|"~     This trial is conducted in Europe, Africa and the United States of America (USA).~      The aim of this trial is to compare the safety and efficacy of two different insulin~     treatments, the basic and the advanced treatment in type 2 diabetes.~   "
230667|NCT00537251|"~     To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of~     treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as~     mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as~     mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety~     of both treatments, evaluated through hypoglycemic rates.~   "
230668|NCT00537238|"~     This study will compare pregabalin and levetiracetam in patients with partial seizures. It~     will also evaluate the safety and tolerability of pregabalin and levetiracetam in these~     patients.~   "
230669|NCT00537225|"~     Patients with peripheral arterial disease (PAD) experience significant functional limitations~     due to ischemic symptoms (claudication) and are at high risk for CVD morbidity and mortality~     resulting from untreated cardiovascular disease (CVD) risk factors and aggressive~     atherosclerosis. The overall Goal of this randomized controlled clinical trial is to examine~     the synergistic effect of a multifactor risk reduction on walking distance, blood flow and~     quality of life in 300 patients with PAD.~      Specifically, we will compare the effects of 24 months of a novel, yet well-tested multiple~     risk factor reduction program, the Health Education and Risk Reduction Training (HEAR2T)~     Program for PAD versus enhanced standard care on: 1) symptom limited walking distance as~     assessed by treadmill exercise testing and walking impairment questionnaire; 2) endothelial~     function as measured by flow mediated vasodilation (FMVD) via brachial artery ultrasound. We~     will also explore the association between FMVD and decreased oxidative stress (as measured by~     oxygen radical absorbance capacity and urinary isoprostanes) and reduced degradation of~     nitric oxide (NO) and/or increased NO biosynthesis (as measured by urine nitrogen oxide,~     plasma nitrogen oxide, plasma asymmetric dimethylarginine, plasma, urine and platelet cyclic~     GMP).~      Secondary hypotheses examine the association between reducing CVD risk factors, improved~     endothelial function, increased walking distance, improved quality of life and number of~     metabolic syndrome abnormalities in PAD patients.~      Significance. This study will contribute to evidence on the efficacy of multiple risk factor~     reduction on improving physical function and quality of life in the understudied, elderly PAD~     patient. This study will also provide preliminary evidence for the biological basis for the~     efficacy of multifactor risk reduction in restoring vascular homeostasis, critical because of~     its role in antiatherogenesis and maintaining vasoreactivity, both necessary for slowing the~     progression of atherosclerosis.~   "
230670|NCT00537212|"~     The association between psoriasis and obesity has been questioned by physicians for many~     years. Studies have shown that the risk of having psoriasis is increased in people with a~     high body mass index, which is a measurement of obesity. There have been case reports of~     remission of psoriasis after gastric bypass surgery. Furthermore, other studies have shown~     that certain inflammatory diseases (such as rheumatoid arthritis) can be improved by dietary~     changes. The purpose of this study is to assess whether a low carbohydrate or low fat diet~     can be helpful in the treatment of psoriasis.~   "
230671|NCT00537199|"~     Primary Objectives:~        1. To assess the ratio in sensitivities of OraTest® in combination with visual examination~          versus visual examination alone in the detection of serious pathology defined as severe~          dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for~          squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the~          oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.~        2. To estimate the adjusted specificity of OraTest® in combination with visual examination~          in the detection of severe dysplasia, CIS, or cancer of the O/OP cavity.~      Secondary Objectives:~        1. To assess the ratio of sensitivity of OraTest® in combination with visual examination~          versus visual examination alone in the detection of certain chromosomal abnormalities~          (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia,~          CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell~          carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP)~          cavity due to their age and lifestyle risk factors.~        2. To obtain the adjusted specificity of OraTest® in combination with visual examination in~          the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both~          3p and 9p chromosomal deletions), severe dysplasia, CIS or cancer of the O/OP cavity.~        3. To evaluate the chromosomal status of the positively staining lesions with respect to~          3p, 9p, or 17p deletions.~        4. To carry out gene expression studies on biopsies and map these onto an analysis of the~          widespread chromosomal imbalances in stain-positive and stain-negative lesions.~        5. To evaluate the quantitative and qualitative toxicities, as well as other safety~          parameters, of tolonium chloride 5 mg/mL (OraTest®).~   "
230672|NCT00537186|"~     The purpose of this study is to determine the safety profile of iron oligosaccharide in~     patients with congestive heart failure with a need for parenteral iron.~   "
230673|NCT00537173|"~     This trial provides a unique opportunity in that it combines genomic, proteomic and~     pharmacogenomic assessments in patients receiving chemotherapy for advanced breast cancer. To~     date no other trials have analyzed gene and protein expression at the same time points in the~     same patient, combined with clinical outcome. Similar to previous attempts to predict~     response based on expression of a single gene or protein, we expect that neither genomic or~     proteomic profiling alone will be sufficient to optimize therapy. Rather, we expect an~     iterative process that combines information gleaned from both platforms, modified to avoid~     toxicity based on pharmacogenomics.~   "
230674|NCT00537160|"~     Examine clinical results of an interdisciplinary weight management program that includes~     medical evaluation, nutrition counseling, exercise, and behavioral interventions.~   "
230675|NCT00537147|"~     West Nile (WN) virus infection is an emerging disease. Infection with WN virus may lead to~     paralysis, coma, and death. The purpose of this study is to determine the safety of and~     immune response to a two-dose regimen of a WN vaccine in healthy adults. The vaccine is based~     on a live attenuated vaccine developed against dengue virus.~   "
230676|NCT00537134|"~     The management of patients with unruptured aneurysms is controversial. Patients with~     unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is~     still debated. Endovascular treatment can prevent rupture, but involves immediate risks;~     furthermore, successful treatment does not eliminate all risks. A randomized trial may be the~     best way to demonstrate the potential benefits of endovascular over conservative management~     of unruptured aneurysms.~   "
230677|NCT00537121|"~     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and~     leucovorin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving vorinostat together with combination~     chemotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when~     given together with irinotecan, fluorouracil, and leucovorin in treating patients with~     advanced upper gastrointestinal cancer.~   "
230678|NCT00537108|"~     Teenagers who become parents often struggle with new challenges as they try to take care of~     their children and themselves. Programs that provide teens with support, education, and~     counseling may help teens to become the best parents they can be and reach their own goals.~     Health care providers who take care of pregnant and parenting teenagers are trying to find~     out what types of programs are most helpful for the physical, emotional, and social health of~     pregnant and parenting teenagers. The purpose of this study is to find out what kinds of~     activities help teens be successful as parents and achieve success in their lives.~   "
230712|NCT00536640|"~     This study wants to determine the activity of a non chemotherapy first line biological~     treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with~     the diagnosis of non-squamous advanced Non Small Lung Cancer.~   "
247254|NCT00316628|"~     The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular~     (IM) injection of an adjuvanted influenza vaccine in elderly subjects.~   "
230679|NCT00537095|"~     This is a parallel group, randomized, double blind, placebo controlled, multicentre study~     designed to assess whether vandetanib (ZD6474) confers an improvement in PFS as compared to~     placebo in subject with locally advanced or metastatic papillary or follicular thyroid~     carcinoma failing or unsuitable for radioiodine therapy. The trial should be of a sufficient~     size so that if vandetanib (ZD6474) is truly active there is a high probability that it will~     demonstrate an effect sufficiently promising to warrant a follow-up assessment.~        -  Subjects will be seen weekly for the first 2 weeks, then again at Week 4, Week 8, and~          Week 12 after randomization, and every 12 weeks thereafter. Upon disease progression,~          all subjects (both active and placebo) will be unblinded and given the option to~          discontinue blinded study treatment and enter follow up and survival, or begin open~          label vandetanib (ZD6474) 300 mg treatment. All subjects will be followed to collect~          survival data until ≥50% of subjects have died. Subjects who are taking vandetanib~          (ZD6474) at the time of study closure and wish to remain on therapy will be allowed to~          continue for as long as the Investigator feels that they are obtaining clinical benefit,~          or until they are given another anti-cancer therapy. The safety data from all subjects~          will be assessed on an ongoing basis, including discontinuation and follow up.~        -  Radiologic evaluation using RECIST criteria will be performed every 12 weeks (± 2~          weeks). All medical images will be centralized assessed at the site and centrally~          reviewed. Subjects will be evaluated until progression, and will then be followed up for~          survival, regardless of whether they continue randomized treatment, unless they withdraw~          consent. Post progression open-label vandetanib (ZD6474) will be offered at the~          investigators discretion.~        -  All subjects must submit a suitable archived tumor sample prior to randomization. In the~          event that a suitable archived sample is not available within 2 weeks prior to~          randomization, a fresh tumor sample must be obtained in its place prior to~          randomization. If a subject undergoes the fresh tumor biopsy procedure, this specimen~          will satisfy the first optional tumor biopsy submission should they consent to the~          exploratory part of the study.~   "
230680|NCT00537082|"~     To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese~     patients with relapsing multiple sclerosis (MS)~   "
230681|NCT00537056|"~     To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed~     tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE~     MRI) are better predictors of response to therapy than the current standard of care (CT or~     MRI).~   "
230682|NCT00537043|"~     Carvedilol controlled release is a marketed drug to treat high blood pressure. This study is~     to compare carvedilol controlled release to carvedilol controlled release plus lisinopril~     (fixed-dose combination) after repeat dosing in patients with high blood pressure. This is to~     make sure that when carvedilol controlled release is given with lisinopril it acts the same~     in the body as when given alone. The study will also assess the safety and tolerability of~     the fixed-dose combination.~   "
230683|NCT00537030|"~     This clinical trial is studying the side effects of Erwinia asparaginase and what happens to~     the drug in the body in treating young patients with acute lymphoblastic leukemia who are~     allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing.~   "
230684|NCT00537017|"~     The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in~     participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa~     decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in~     the main study (P04501; NCT00406029) entitled A Phase 2, 12 Week, Double Blind, Dose~     Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814~     Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations~     and Dyskinesias.~   "
230685|NCT00537004|"~     The purpose of this study is to further define the neurological and linguistic deterioration~     in primary progressive aphasia.~   "
230686|NCT00536991|"~     This phase I/II trial studies the side effects and best dose of calcitriol when given in~     combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in~     treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more~     like normal cells and grow and spread more slowly. Ketoconazole and therapeutic~     hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the~     drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a~     better treatment for prostate cancer.~   "
230687|NCT00536978|"~     Primary objective:~        -  To determine the safety of adback T- or Natural Killer (NK) cells in patients with~          lymphoid malignancies receiving allogeneic stem cell transplantation with Campath-IH~          containing conditioning regimen.~      Secondary objective:~        -  To determine the efficacy (disease-free-survival) of this strategy.~   "
230688|NCT00536965|"~     A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia~     (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and~     rate of patients who are treated to target (which is <100mg/dl for patients with high risk~     and <70mg/dl for patients at very high risk) are screened (office-based specialists). The~     doctors therapy decisions after the screening and possible reasons for these decisions will~     be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are~     treated to their LDL-C target and to underline the importance of treating patients to their~     cholesterol targets.~   "
230689|NCT00536952|"~     RATIONALE: Nebulized dornase alfa inhalation solution may decrease the thickness of saliva in~     the mouth and improve quality of life in patients undergoing radiation therapy and~     chemotherapy for head and neck cancer. It is not yet known whether dornase alfa inhalation~     solution is more effective than a placebo in lessening the discomfort of treatment in these~     patients.~      PURPOSE: This randomized clinical trial is studying how well dornase alfa inhalation solution~     works compared with a placebo in treating patients with stage III or stage IV head and neck~     cancer undergoing radiation therapy and chemotherapy.~   "
230690|NCT00536939|"~     The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and~     enzastaurin versus paclitaxel, bevacizumab, and placebo in patients who are diagnosed with~     locally recurrent or metastatic breast cancer.~   "
230691|NCT00536926|"~     In an investigation should be evaluated in contrast to a control group with standard~     post-treatment therapy (using home spirometry) after lung transplantation if transfer of home~     spirometry recordings to the transplant center via cell phones will lead to less~     complications, cost savings and bigger constancy of therapy.~   "
230692|NCT00536913|"~     The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of~     steroid potency, improvement of lung function and asthma symptoms in children with asthma~     (6-11 years).~   "
230693|NCT00536900|"~     This is a randomized controlled trial to test whether a money-management based intervention~     reduces substance abuse.~   "
230713|NCT00536627|"~     The purpose of this study is to determine if DNA vaccination of chronic HBV patients under~     treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after~     treatment discontinuation.~   "
230694|NCT00536887|"~     Many data indicate that statins increase mobilization of bone marrow-derived stem cells, and~     circulating bone marrow-derived stem cells are capable of homing to sites of myocardial~     infarction and endothelial disruption, thereby restoring myocardial function and~     microvascular integrity after acute myocardial infarction. Atorvastatin is widely used in the~     treatment of hyperlipidemia, especially after acute myocardial infarction. High-dose~     atorvastatin has been known to stop the progression of atherosclerosis and to decrease the~     levels of inflammatory markers.~      The purpose of this prospective, randomized, single-blinded trial is to compare the effect of~     atorvastatin 10 mg versus 40 mg in restoring coronary flow reserve (CFR) and in serial bone~     marrow stem cell mobilization during the 8 months follow-up in patients with acute myocardial~     infarction.~   "
230695|NCT00536874|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount~     of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any~     tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     oxaliplatin works in treating patients with pancreatic cancer that can be removed by surgery.~   "
230696|NCT00536861|"~     Lung cancer is a leading cause of death worldwide. Brain metastases manifest as the first~     site of disease failure in between 15-30% of patients with non-small cell lung cancer~     (NSCLC). The standard treatment for patients with multiple brain metastases is whole brain~     radiotherapy but this results in only a modest survival of 3-6 months. Drugs that can enhance~     the effect of cranial irradiation (radiosensitizers) may improve the the response rates.~     Erlotinib (Tarceva) is an oral agent that has been registered for treatment in patients with~     metastatic NSCLC. Erlotinib has shown tumor activity in patients presenting with brain~     metastases, and preclinical studies show that it may be a radiosensitizer. As a prelude to~     studies investigating the combination of Erlotinib and cranial radiotherapy, the present~     study will be performed to evaluate the safety of combining both these treatments.~   "
230697|NCT00536848|"~     The purpose of this study is to asses whether probiotics Lactobacillus rhamnosus (GR-1) and~     reuteri (RC-14) are able to prevent diarrhea, delay the decline of the immune system and~     prevent and/or cure bacterial vaginosis among HIV patients.~   "
230698|NCT00536835|"~     This is a first time in human study that is being done to determine the maximum tolerated~     dose and initial pharmacokinetic parameters of GSK461364, given by IV, in adult subjects with~     solid tumors and Non-Hodgkins lymphoma.~   "
230699|NCT00536822|"~     It is believed that children with a prior history of significant burn injury continue to~     manifest low levels of antioxidants well into their convalescence.The purpose of this study~     is to examine malondialdehyde (an oxidative lipid marker) and vitamins E, C and beta carotene~     status in reconstructive burn patients.~   "
230700|NCT00536809|"~     The purpose of this study is to determine the highest, tolerated dose level and safety of~     lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the~     clinical activity of the combination of drugs in subjects with previously untreated advanced~     or metastatic colorectal cancer.~   "
230701|NCT00536796|"~     A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia~     (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and~     rate of patients who are treated to target (which is <100mg/dl for patients with high risk~     and <70mg/dl for patients at very high risk) are screened (hospital-based specialists). The~     doctors therapy decisions after the screening and possible reasons for these decisions will~     be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are~     treated to their LDL-C target and to underline the importance of treating patients to their~     cholesterol targets.~   "
230702|NCT00536783|"~     The purpose of this study is the use of magnetoencephalography or MEG (a machine that~     measures magnetic activity in your brain) and electroencephalography or EEG (a technique that~     measures electrical activity in your brain) to study how sounds are processed in individuals~     with schizophrenia after three months of taking the antipsychotic medication quetiapine.~   "
230703|NCT00536770|"~     The purpose of this study is to determine the safety and efficacy of an investigational study~     drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the~     treatment of pancreatic cancer.~   "
230704|NCT00536744|"~     The purpose of this study is to compare the safety and effectiveness of the dermaPACE Device~     to sham application, when administered in conjunction with standard treatments used in the~     treatment of DFUs.~   "
230705|NCT00536731|"~     The purpose of the this study is to evaluate the efficacy and safety of 2 actuations~     Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5~     μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.~   "
230706|NCT00536718|"~     RATIONALE: Gathering information about genetic changes in patients with lobular carcinoma in~     situ of the breast may help doctors learn more about the disease and find better methods of~     treatment.~      PURPOSE: This clinical trial is studying the genetics of women with lobular carcinoma in situ~     of the breast.~   "
230707|NCT00536705|"~     The Objective of our research is to observe the effect of cysteinyl leukotriene receptor~     antagonist on the expression and variation of TGF-β1 levels and mRNA expression in children~     with mild persistent asthma in their plasma and T lymphocyte, to discuss the role of TGF-β1~     in the pathogenesis of bronchial asthma in children and to evaluate the function of~     regulation of leukotriene receptor antagonist on asthma in children.~   "
230708|NCT00536692|"~     This is an open-label study evaluating the safety and tolerability of topical ocular~     mecamylamine given twice a day in patients with diabetic macular edema (DME). Patients will~     be treated for 12 weeks.~   "
230709|NCT00536679|"~     The study will consist of a screening period, 3 treatment periods and a post-treatment~     follow-up. In each of the 3 treatment periods, subjects will receive a single oral dose of~     GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose~   "
230710|NCT00536666|"~     The purpose of this study is to determine the safety profile of iron oligosaccharide in~     patients with chronic kidney disease with a need for parenteral iron.~   "
230714|NCT00536614|"~     This is multicenter, open-label, randomized, phase II trial in patients with locally advanced~     or metastatic pancreatic cancer. Primary objective: objective response rate. Secondary~     objectives: safety, time to disease progression, median duration of response, time to~     treatment failure, overall survival time, correlation between bio-pathological~     characterization (EGFR, akt, MAPks) objective response and survival~   "
230715|NCT00536601|"~     This pilot trial studies different high-dose chemotherapy regimens with or without total-body~     irradiation (TBI) to compare how well they work when given before autologous stem cell~     transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving~     high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by~     stopping them from dividing or killing them. After treatment, stem cells are collected from~     the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for~     the stem cell transplant. The stem cells are then returned to the patient to replace the~     blood forming cells that were destroyed by the chemotherapy.~   "
230716|NCT00536588|"~     The purpose of this first-in-human study is to determine the safety and tolerability of SCH~     721015 in subjects with transitional cell carcinoma of the bladder.~   "
230717|NCT00536575|"~     This is a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in~     initial patients. The initial patients on the dose-finding portion of this study will be~     enrolled through a single institution. Following establishment of the Phase II dose the study~     will open enrollment throughout the Sarah Cannon Research Institute (SCRI) Oncology Research~     Consortium.~      The purpose of this study is to develop the combination of bortezomib (which is proven to be~     clinically active in patients with multiple myeloma) with sorafenib (a potent inhibitor of~     angiogenesis). This regimen will be developed in a schedule that is convenient for patients,~     and that is as minimally toxic to patients as possible.~   "
230718|NCT00536562|"~     The purpose of this study is to determine, in patients following a TIA, whether a 6-month~     case-managed exercise based multi-factorial cardiac rehabilitation program (CR), similar to~     those used in patients following a heart attack, can significantly improve exercise capacity,~     reduce cholesterol, reduce depression, and improve thinking ability.~   "
230719|NCT00536549|"~     The purpose of this study is to determine whether the Guardian Continuous Glucose Monitoring~     System in the home setting is more useful than frequent self blood glucose monitoring with a~     view to modifying patient's diet and exercise habits or improvement self disease control~     efforts and at last glycemic control in patients with type 2 diabetes~   "
230720|NCT00536536|"~     Obesity affects one in five children in the UK and undoubtedly causes increased ill health~     with rising levels of childhood and adolescent diabetes, obesity induced liver disease and~     increased risk of early heart disease. There are few clinics offering effective treatment for~     childhood obesity. However, the clinic for childhood obesity at Bristol Royal Hospital for~     Children (BCH) has been successful in around 83% of cases. This pilot study aims to examine~     the feasibility of transferring the success of the hospital clinic to primary care in~     preparation for a full RCT. The study will entail training a practice nurse, community~     dietician and exercise specialist to deliver the same clinical service in primary care as~     that offered in BCH. Initial work will gather the views of staff delivering the hospital~     service and those of patients and parents to identify the crucial components of the~     intervention that are likely to be needed in primary care and to then to refine the~     intervention.A pilot trial will examine how feasible it is to recruit patients into the~     service and get some initial idea as to whether weight management is equally good, patient~     satisfaction and retention improves and what data needs to be collected for a full economic~     assessment. If found to be effective, the next step will be to use knowledge gained in this~     study to design and undertake a more extensive, formal study across Bristol in various~     primary care settings.This larger study will address how such a service can be delivered~     across a complete spectrum of primary care populations, so that similar services could be~     developed across the country.~   "
230721|NCT00536523|"~     RATIONALE: Gathering information about changes in serotonin levels in patients undergoing~     chemotherapy for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer may help~     doctors learn more about constipation caused by chemotherapy.~      PURPOSE: This clinical trial is studying how blood levels of serotonin effect constipation~     caused by chemotherapy in patients with newly diagnosed ovarian cancer, fallopian tube~     cancer, or primary peritoneal cancer.~   "
230722|NCT00536510|"~     The primary objective of the study is to assess the effects of MK0524A in reducing~     cholesterol levels in an Asian population.~   "
230723|NCT00536497|"~     GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical~     development as a novel oral treatment for inflammatory pain. The purpose of the study is to~     compare the effects of formulation, food and particle size on the pharmacokinetic profiles of~     a single 175mg dose of GW842166X in healthy male and female volunteers.~   "
230724|NCT00536484|"~     This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more~     effective than placebo in reducing micturition frequency and other overactive bladder (OAB)~     symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder~     and if the fesoterodine regimen is safe and well tolerated.~   "
230725|NCT00536471|"~     Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized,~     placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to~     compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on~     depression in patients aged 18-65. Data from the two trials will be reported in both~     individual and pooled analyses. Pooling the two studies will allow for increased power to~     detect differences between duloxetine and placebo on secondary and exploratory objectives.~     Only one data lock is planned for this study, when all patients have completed all study~     procedures.~   "
230726|NCT00536458|"~     To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of~     chemotherapy in the treatment of localiezd low grade lymphoma~   "
230738|NCT00536302|"~     This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects.~     Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the~     other half of the subjects will take a placebo dose, that looks like and tastes like the~     collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and~     48.~   "
230727|NCT00536445|"~     The present protocol will demonstrate the feasibility and efficacy of a newly developed mode~     of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA.~     During NAVA, the timing and magnitude of pressure delivered are controlled by the infants'~     diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive.~     Recent clinical trials in adults and term infants have shown that NAVA is more synchronous~     than conventional pressure support ventilation, and that NAVA delivers lower mean airway~     pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently~     been approved for use in neonates by Health Canada and the FDA in the United States, and is~     commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The~     present protocol is designed as a case study where the researchers responsible would like~     to evaluate the feasibility and efficacy of ventilating a premature baby on NAVA with the~     Servoi for 12 hours.~   "
230728|NCT00536432|"~     Tetralogy of Fallot is one of the most frequent congenital heart malformations. In many cases~     re-interventions, surgical or catheter-based, are necessary after the repair of tetralogy of~     Fallot in infancy. At present, informations in the literature about the myocardial benefit~     and the timing of re-interventions are missing in this age group. On the other hand, Fallot~     patients are dependent on solid criteria for re-interventions, because further interventions~     like replacement of the pulmonary valve or balloon dilatations of peripheral pulmonary~     stenoses are common.~      The objective of this study is to assess the benefit of such interventions for the right~     ventricular function. By performing extensive standardised examinations (including MRI,~     echocardiography, tissue Doppler,,3D-echocardiography, holter monitoring and quality of life~     assessments) before and 6 to 9 months after the re-intervention data of the right ventricular~     function are collected. Based on these quantitative data predictive parameters concerning the~     right ventricular recovery and information about the time of re-intervention should be~     determined.~   "
230729|NCT00536419|"~     The purpose of this study is to determine whether motorcycle drivers with ADHD are at a~     greater risk for motorcycle accidents, and whether this risk can be mitigated by treatment~     with methylphenidate. We will evaluate the effectiveness of Methylphenidate on driving~     performance, among motorcycle drivers, and investigate the correlation between improvement of~     ADHD symptoms (inattention and impulsivity) and driving performance.~   "
230730|NCT00536406|"~     This study will evaluate whether a behavioral activities treatment program improves symptoms~     of depression in nursing home residents.~   "
230731|NCT00536393|"~     Interest of the use of pegylated liposomal doxorubicin (caélyx)~   "
230732|NCT00536380|"~     This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20~     mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria.~     Subjects with chronic urticaria who are currently taking a second generation antihistamine~     will be treated with desloratadine (5, 10, or 20 mg) for 28 days.~   "
230733|NCT00536367|"~     The purpose of this protocol is to determine if the 3 variable mortality prediction model~     established using data from a retrospective, multi-center patient registry (The ADHERE Acute~     Decompensated HEart FailuRE National Registry) will hold for a prospective, observational~     outcome study of OSU patients diagnosed in the Emergency Department (ED)with Acute~     Decompensated Heart Failure (ADHF). In the retrospective registry, three parameters were~     found to be highly predictive of inpatient mortality for patients admitted with ADHF - on~     admission, BUN > 43 mg/dL, systolic BP < 115 mmHg, and Cr > 2.75 mg/dL. However, the very~     nature of the ADHERE database limited the analytic potential of this model, as the data~     captured by ADHERE is retrospective and limited to the inpatient stay, and the only outcome~     evaluated was inpatient mortality. Due to its inherent limitations, the model did not and~     could not address longer term outcomes, such as repeat visits to the emergency department~     after discharge, or need for readmission to an acute care setting, which frequently occurs~     soon after discharge in patients who survive to discharge after being admitted with ADHF.~      This observational study will create a registry of patient information obtained from an~     interview with the patient and a review of the patient's medical record. Follow up~     information at 30 days post discharge will be obtained by phone interview with the patient~     and a review of the patient's OSUMC visit history.~      Most ED patients diagnosed with ADHF are admitted, as emergency physicians are aware that~     heart failure in general carries a very high mortality rate. However, as risk stratification~     for ADHF is a severely under researched area, it is not at all clear which patients with~     acutely decompensated heart failure will have a poor outcome in the short and intermediate~     term. With an improved understanding of the risk profile of our ADHF patients, more~     appropriate decision making and disposition assignment can be made.~   "
230734|NCT00536354|"~     This study will examine the effects of postural orientation in the use of school backpacks~     among elementary school students.~   "
230735|NCT00536341|"~     This phase I/II trial will combine fludarabine, rituximab, and lenalidomide in untreated or~     minimally treated (Phase I only) CLL patients, employing fixed doses of fludarabine and~     rituximab, using a schedule similar to that examined by investigators at MD Anderson (J Clin~     Oncol 23(18):4079-88, 2005). Given that the optimal dose and schedule is not currently known,~     this trial will perform a phase I component followed by a phase II examination to further~     explore this regimen's activity.~   "
230736|NCT00536328|"~     Gastric distress is a common phenomenon in our society. Heartburn and regurgitation occur~     daily in about 7% of the adult population,weekly 14-20% pf the adults and monthly in 34-44%~     of adults. The yearly prevalence of recurrent stomach complaints are frequent reason for~     consulting a primary care physician and are an important reason for using OTC medication. A~     good diagnosis is important as functional GERD with possible complications such as strictures~     and Barrett's esophagus or ulcer disease with life threatening complications such as bleeding~     & perforations. The clinical diagnosis of reflux disease is mainly based on symptom~     evaluation. This, however, is hindered by the variety of complaints with different etiology.~     Treatment with a proton pump inhibitor can be used to confirm the diagnosis reflux disease. A~     major part of the patients with acid related stomach complaints indeed will experience~     symptom relief after starting PPI therapy. In this view, it is important to identify these~     patients who will react on treatment with PPI in quick, accurate, non-invasive and cheap~     manner. The Reflux Impact Scale (RIS) is validated, short, self explanatory questionnaire~     which asks for the presence & impact of reflux symptoms. The RIS is developed for PCP to aid~     in the evaluation & selection of these patient who will profit from treatment with PPI. The~     aim of this present study is to determine which questions of the RIS can be predictive for~     reaching treatment success with PPI. Treatment success is determined by asking for patients'~     satisfaction & completion of the McMaster Overall Treatment Evaluation Heartburn~     questionnaire.~   "
230737|NCT00536315|"~     The main purpose of this study is use a new type of measurement to help decide what kind of~     therapy would help people with a collapsing windpipe or tracheomalacia.~   "
230741|NCT00536263|"~     The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron~     for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the~     approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks.~     This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg~     once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks~     after their treatment ends.~   "
230742|NCT00536250|"~     The purpose of the study is to determine the role of beta-cell function and insulin~     resistance in the development of impaired glucose tolerance (IGT) and type 2 diabetes in~     children and adolescents who have an increased risk of developing type 2 diabetes due to~     overweight/obesity or a family history of overweight/obesity, diabetes and/or impaired~     fasting glucose. It is hypothesized that: 1)Obese adolescents with IGT will be more insulin~     resistant than obese adolescents with NGT. Insulin resistance will be the best predictor of~     changes in glucose tolerance status., 2)Beta cell function will be impaired in obese~     adolescents with IGT compared to obese adolescents with NGT., 3)Obese adolescents with IGT~     will present with greater intramyocellular, intrahepatic and visceral fat than obese~     adolescents with NGT. Furthermore, obese adolescents with IGT will have larger adipocytes,~     while having significantly fewer adipocytes compared to obese adolescents with NGT. Obese~     adolescents with IGT will also have altered expression of key genes related to insulin~     resistance., and 4)Abnormalities in endothelial function as manifested by low FMD and PAT are~     already present in obese adolescents with IGT and are linked to insulin resistance.~   "
230743|NCT00536237|"~     Part A: This study will determine that MK0524 is well tolerated and does not effect lipids~     and blood glucose when given alone.~      Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids~     and blood glucose.~   "
230744|NCT00536224|"~     The purpose of this study is to determine whether a brief counseling intervention initiated~     in the chest pain observation unit has a significant impact upon the health attitudes~     (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking)~     of emergency department patients.~   "
230745|NCT00536211|"~     The purpose of this study is to determine how a decline in physical activity acutely leads to~     a decrease in insulin sensitivity in skeletal muscle. The hypothesis is that the loss of~     insulin sensitivity following physical inactivity is caused by a rapid reduction in skeletal~     muscle mitochondrial oxidative capacity.~   "
230746|NCT00536198|"~     This study will evaluate the effectiveness of sertraline in reducing symptoms in women~     diagnosed with premenstrual dysphoric disorder.~   "
230747|NCT00536185|"~     We hope to learn more about why certain people have higher levels of the 5-LO protein and~     whether taking fish oil supplements gives such individuals greater protection than others~     against cardiovascular disease. The 5-LO protein is important in the development of heart~     disease because it converts a type of oil from meat into a compound that can cause~     inflammation in blood vessels. This inflammation is a major cause of heart disease.~      Researchers think that people with higher levels of a protein called 5-LO in their white~     blood cells may have a healthier response to using fish oil supplements than do people with~     lower levels of this protein.~   "
230748|NCT00536172|"~     This study will evaluate the effectiveness of escitalopram to prevent depression in head and~     neck cancer patients receiving treatment.~   "
230749|NCT00536159|"~     Our objective was to test whether there were advantages to Nurse-CHW team home visiting~     designed to combine the strengths of both visitors, with a focus on maternal stress and~     mental health, when compared with standard of Community Care (CC) that included professional~     home visitors in a state-sponsored Medicaid program. We conducted the study under usual~     community conditions in a population of women eligible for state-sponsored Medicaid programs.~     We predicted that during pregnancy and infancy, women in the Nurse-CHW team intervention~     would report 1) less perceived stress; 2) fewer depressive symptoms; and 3) increased levels~     of psychosocial resources (self-esteem, mastery, and social support) than women in CC.~     Benefits were expected to be most pronounced for women with low psychosocial resources and~     high stress at enrollment.~   "
230750|NCT00536146|"~     This study, conducted at the University of Texas Southwestern Medical Center and the Parkland~     Hospital in Dallas, will examine the stress hormone system of alcohol-dependent people. This~     system is weakened in alcohol-addicted people. This study will determine how long it is~     weakened, whether other hormone systems are also weakened and whether changes in the hormone~     system are associated with previous trauma or stress.~      Healthy normal men and men who are alcohol-dependent may be eligible for this study.~     Candidates must be between 21 and 60 years of age and have at least a 5-year history of~     active alcohol dependence. They are screened with a medical history, blood and urine tests~     and questions about alcohol and drug use, psychiatric problems, history of trauma and recent~     stress.~      Participants undergo the following procedures:~      Day 1 - Public Speaking Task~      At 6:00 PM subjects have an I.V. line (needle attached to a small plastic tube) inserted into~     a vein in each arm to draw blood samples and give medication. They are then given a light~     dinner and then lie down and rest. They rinse their mouth out with water and a drop of lemon~     juice is placed on their tongue. In 30 to 40 seconds they spit into a funnel attached to a~     collecting tube. A blood sample is collected to measure levels of cortisol (a stress hormone)~     ACTH (a hormone responsible for the release of cortisol) and neurosteroids (hormones that~     affect the brain). Subjects then give a 5-minute speech (telling an ending to a story) and~     solve a math problem in front of a small group of people. They are then asked how they are~     feeling. Saliva and blood samples are then collected every 10 minutes for the next 60~     minutes.~      Day 2 - Cosyntropin Study~      At 6:30 p.m. subjects have an I.V. line inserted into a vein in each arm. At 7:45 PM and 8:30~     PM saliva is collected as described above. Starting at 7:30 PM, blood samples are collected~     every 10 minutes until 9:00 PM and then every 20 minutes until 10:00 PM. At 8:00 PM~     cosyntropin (a medicine that stimulates production of cortisol) is given through the I.V.~     over 1 minute.~      Day 3 - oCRH Study~      At 6:30 p.m. subjects have an I.V. line inserted into a vein in each arm. At 7:45 PM and 8:30~     PM saliva is collected as described above. Starting at 7:30 PM, blood samples are collected~     every 10 minutes until 9:00 PM and then every 20 minutes until 10:00 PM. At 8:00 PM ovine CRH~     (a medicine that stimulates production of cortisol) is given through the I.V. over 1 minute.~      Participants may be asked to repeat these studies 3 months later.~   "
230772|NCT00535860|"~     The purpose of this study is to assess the clinical efficacy, safety, and tolerability of~     ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of~     rhPTH[1-34] following 3-month treatment in postmenopausal women with Osteoporosis~   "
230773|NCT00535847|"~     To provide access to a telaprevir-based treatment to subjects of the Control Group of Study~     VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who~     stopped treatment due to inadequate response to treatment. Safety, tolerability, and~     Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.~   "
230774|NCT00535834|"~     RATIONALE: Studying samples of blood in the laboratory from patients before and after~     treatment may help doctors learn more about the effects of the treatment on cells.~      PURPOSE: This clinical trial is studying samples collected from patients with localized~     prostate cancer who received treatment on clinical trial NCI-00-C-0154.~   "
230751|NCT00536133|"~     Acute respiratory infections (ARIs) are the most frequent illnesses globally. Despite~     advances in the recognition and management ARIs, these account for over 20% of all child~     deaths globally.Trace mineral deficiencies have long been implicated in causation and~     consequences of many diseases. The importance of adequate zinc intake in human health is well~     documented and zinc deficiency is a large public health problem, especially among children in~     developing countries.Various studies suggest that zinc-deficient populations are at increased~     risk of developing diarrhoeal diseases, respiratory tract infections and growth~     retardation.Among the individual interventions zinc supplementation with universal coverage~     ranks 5th in preventing under five mortality in India, preceded only in order by breast~     feeding; complementary feeding; clean delivery; Hib vaccination; and clean water, sanitation~     and hygiene.Numerous studies have examined the association between child mortality and zinc~     deficiency. A number of randomized controlled trials evaluating effect of zinc~     supplementation have found the intervention to be beneficial in reducing ARI and diarrhoeal~     mortality and morbidity but few studies have found beneficial effect in diarrhea and no or~     even contrasting effects on morbidity pattern of acute respiratory infections. Whereas role~     of zinc in diarrhea is now a well established and specific guidelines and recommendations~     have been given for zinc supplementation in diarrhea, role of zinc in acute respiratory~     infections is controversial. The contrasting effect of zinc on diarrhoea and acute lower~     respiratory infection as reported in several studies is a public health concern, because zinc~     supplementation is carried out in many nutrition rehabilitation units. Further in many of~     randomized control trials supplement syrups also contained other vitamins, including vitamin~     A, known to have effect on respiratory morbidity. Most of the trials evaluating effect of~     zinc on respiratory morbidity and mortality are community based and children with well known~     causes of recurrent acute lower respiratory infections have not been excluded from the study~     pool.~      Hence the current study was planned to bridge this gap of information and attempts to detect~     the role of zinc using zinc only preparations in reducing respiratory morbidity in children~     aged 6 to 59 months with recurrent acute lower respiratory infections.~   "
230752|NCT00536120|"~     The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab)~     on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin [KLH])~     and a recall antigen (tetanus toxoid [Td]), and to evaluate the effect of Tysabri on~     circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) over time in participants~     with relapsing forms of multiple sclerosis (MS). The secondary objective was to assess~     alpha4-integrin saturation and alpha4-integrin expression levels over time.~   "
230753|NCT00536107|"~     This is a randomized, open- label, parallel group, phase IV, multicentre study. The total~     number of patients expected to be recruited is 40. These randomized patients will have a~     histologically or cytologically confirmed adenocarcinoma histology of locally advanced or~     metastatic NSCLC. Patients will be recruited by investigational sites that have expertise in~     treating patients with non-small cell lung cancer. The study will compare gefitinib~     monotherapy 250 mg/day orally with docetaxel 60 mg/m2 intravenously over 1 hour every 3 weeks~     with a primary endpoint of safety and tolerability. The target population will be patients~     who have received one prior platinum-based chemotherapy and are now considered suitable~     candidates for further chemotherapy with docetaxel. At study entry, patients will be~     randomized on a 1:1 basis stratified with respect to performance status (0-1 vs. 2). Patients~     may continue to receive treatment with either gefitinib or docetaxel until disease~     progression, unacceptable toxicity or the occurrence of any of the other specific criteria.~     An independent committee will be appointed to perform a blinded review of all patient scans.~     Any assessments/visits after screening should be performed within a window of plus or minus 3~     working days of the scheduled visit date. If selected screening evaluations are done within 7~     days of Day 1, Cycle 1 of treatment, and are acceptable for study entry, they do not have to~     be repeated on Day 1 unless the investigator believes that they are likely to have~     significantly changed. Any patient who discontinues from study treatment without radiological~     evidence of disease progression (except for withdrawal of consent by patient) should continue~     to have objective tumor assessments every 6 weeks in order to collect information on~     progression of disease~   "
230754|NCT00536094|"~     This study will determine the effectiveness of a school-based cognitive behavior therapy in~     urban, predominantly low-income, African-American children diagnosed with an anxiety~     disorder.~   "
230755|NCT00536081|"~     The purpose of this study is to prevent chemotherapy-related febrile neutropenia, prophylaxis~     with antibiotics and granulocyte colony-stimulating factor (G-CSF) have proven efficacious~     [1-3]. G-CSF has only few side effects, but is expensive. In 2006, updated G-CSF guidelines~     conclude that primary G-CSF prophylaxis has clinical benefits for and should be offered to~     patients at a more than 20% risk of febrile neutropenia.~      Based on many positive and few negative trials, one can consider the use of taxanes as~     standard of care in the adjuvant setting in node-positive breast cancer. Taxanes (with or~     without anthracyclines) have an increased risk for febrile neutropenia.~      The updated guidelines and changes in daily clinical practice will have a significant impact~     on the investigators health care resources. There is a higher risk of febrile neutropenia for~     the first chemotherapy cycle compared to subsequent cycles in small cell lung cancer~     patients. Also in advanced breast cancer the majority of first observed episodes of febrile~     neutropenia occur in the initial chemotherapy cycles Irrespective of tumour type or~     chemotherapy regimen, the risk of febrile neutropenia is highest during the first two cycles~     of chemotherapy. Thereafter, the risk rapidly declines, and the benefit of G-CSF largely~     seems to disappear.~      So, in order to improve the cost-effective administration of primary G-CSF prophylaxis, it is~     justified to assess whether G-CSF prophylaxis can be limited to the first two chemotherapy~     cycles as compared to the current practice of continuous G-CSF prophylaxis.~   "
230756|NCT00536068|"~     Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the~     inhibition of platelet aggregation by aspirin, because they all interact with the platelet~     cyclooxygenase.This may be of great clinical importance because of an increased~     cardiovascular event rate (myocardial infarction, stroke). The present randomized, controlled~     study analyses in vitro platelet aggregation under a combined treatment of healthy volunteers~     with aspirin and either acetaminophen, diclofenac, naproxen, or placebo.~   "
230775|NCT00535821|"~     Early intervention in the treatment of septic shock, including early goal-directed therapy~     (EGDT) in the first 6 hours of disease presentation, has been shown to significantly decrease~     mortality. However, this approach requires invasive hemodynamic monitoring, thus limiting its~     widespread application in the emergency department setting. A minimally invasive protocol~     utilizing esophageal Doppler monitoring (EDM) may be of benefit and practical if it is shown~     to result in similar outcome as EGDT.~   "
230837|NCT00535002|"~     Stress and cues reminiscent of cocaine use promote craving and relapse in cocaine dependent~     individuals. In addition, there appears to be gender differences in determinants of relapse~     to drug use following abstinence in cocaine-dependent individuals. Therefore the purpose of~     the present study is to study the role of hormonal status on the response to cocaine-related~     cues with or without stress in cocaine-dependent women and men.~   "
230757|NCT00536055|"~     The purpose of this study is to focus on dyadic coping as one of the main factors that~     enhance resilience in adjustment to cancer, while also assessing other protective factors for~     coping with traumatic events.~      Specifically, the study aims are:~        1. To assess the level of post traumatic distress, functional impairment and depression~          among breast and prostate cancer patients and their spouses.~        2. To assess resiliency factors such as flexibility, self efficacy and ego resilience among~          breast and prostate cancer patients and their spouses.~        3. To examine the pattern of dyadic coping at 3 time points: at the beginning and end of~          radiation therapy, and at six-week follow-up.~        4. To examine the relationships between dyadic coping and level of posttraumatic distress~          and the resilience factors over time (in 3 repeated measures) Different aspects of~          coping with the trauma of cancer and its treatment may be assessed. Measures of strength~          and distress amongst patients and their spouses may enable a fuller picture of what~          types of responses exist, which interventions may be most beneficial, and what other~          factors may relate to positive coping, increased resilience and quality of life, such as~          flexibility, and the nature of the couples' dyadic coping.~   "
230758|NCT00536042|"~     The tetracycline minocycline has, in addition to its anti-infective properties,~     anti-inflammatory properties which may be of use in the treatment of asthma. This study~     evaluates the benefit of minocycline as add-on therapy for adults with asthma.~   "
230759|NCT00536029|"~     Spectrophotometric intracutaneous analysis (SIAscopy) is a new technique for imaging~     pigmented skin lesions and for diagnosing melanoma and non-melanoma skin cancer. The SIAscope~     is a portable system comprising of a laptop computer connected to a small handheld skin probe~     equipped with a light source. The skin lesion is interrogated with light of different~     wavelengths and the reflection spectra analysed by proprietary algorithms showing~     distribution, position and quantity of melanin, blood and collagen within the papillary~     dermis (the SIAgraphs). Earlier studies generated promising results and documented >80%~     specificity and sensitivity of SIAscopy for melanoma diagnosis. It has been suggested that~     this technique could be used for the initial screening and selection of pigmented lesion for~     excision. In this work we addressed the usefulness of SIAscopy for the clinical diagnosis of~     pigmented malignant melanoma in a prospective, blinded design.~   "
230760|NCT00536016|"~     The purpose of this study is to determine the way and rate that the study medication, JSM6427~     a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated~     from the body when it is given as a single dosage strength by injection into the eye.~     Repeated dosages will also be given to determine the highest safe dose.~   "
230761|NCT00536003|"~     The administration of vaginal progesterone, in addition to standard tocolysis, will decrease~     the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that~     the reduction in preterm delivery will be associated with a decrease in infant mortality and~     morbidity.~   "
230762|NCT00535990|"~     The Minimally Invasive Surgery Team (MIST) are establishing a separate research database to~     find out more about patient's undergoing minimally invasive surgery (laparoscopic , open and~     robot assisted) procedures at UCSD. The hope is that collection of this information will give~     physicians a better knowledge and understanding of the benefits of minimally invasive surgery~     and possibly assist physicians to better manage future patients.~   "
230763|NCT00535977|"~     This is a parallel human intervention trial to determine to what extent a dietary~     intervention of broccoli or peas can change the expression (switching on or off) of genes in~     prostate tissue in men diagnosed with high-grade Prostate Intraepithelial Neoplasia (PIN).~   "
230764|NCT00535964|"~     This study will determine whether there is a relationship between tobacco use and a~     heightened response to panic-producing events among adolescents. This study is fundamental~     research. It was not a Clinical Trial.~   "
230765|NCT00535951|"~     This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6~     substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication~     in advanced stage NSCLC or malignant pleural mesothelioma patients~   "
230766|NCT00535938|"~     The MOBILITY Project is a prospective, non-randomized, observational, multi-centre evaluation~     of Health Utility via the SF-12® Health Survey Scores and the SF-6D in patients receiving~     BOTOX® for therapeutic use.~   "
230767|NCT00535925|"~     The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases:~      Phase 1(observational study, completed at 2007): after the identification of a type-2~     diabetic population with typical DN, to study of the rate of renal and cardiovascular events~     during a middle term follow-up.~      Phase 2(interventional study, started at 2007): after randomization in two groups, a group~     (intervention group) is treated with an intensive multifactorial intervention whose aim is to~     reduce morbidity and mortality due to diabetic complications. The other group (control group)~     continues the conventional therapy . To avoid bias in the treatment in each center, the~     randomization was performed for centre.~   "
230768|NCT00535912|"~     GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C~     Binet stages B-CLL and on an intent to treat basis two strategies. Conventional chemotherapy~     consisted of six monthly courses of CHOP, followed by 6 CHOP courses every other 3 months in~     case of response. Experimental arm consisted of high dose therapy with autologous CD34+~     purified progenitor cell support, used as consolidation of Complete Remission or Very Good~     Partial Response obtained after 3 monthly courses of CHOP, followed by 3 to 6 monthly-courses~     of fludarabine in case of insufficient response.~   "
230769|NCT00535899|"~     In patients with aortic stenosis and low ejection fraction, how can we predict who will~     recover their ejection fraction after aortic valve replacement? We plan to observe 50~     patients with Low EF aortic stenosis and perform serial echocardiograms pre and post-aortic~     valve replacement and analyze regional wall motion contractility with a new software~     application called speckle tracking imaging.~   "
230770|NCT00535886|"~     The purpose of this study is to test the effects of natural vs. man-made trans fatty acids~     (trans fats) on blood cholesterol.~   "
230771|NCT00535873|"~     Primary Objective:~        -  To assess the activity of lenalidomide in patients with previously untreated chronic~          lymphocytic leukemia (CLL) age 65 and older.~      Secondary Objective:~        -  To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and~          older~   "
230776|NCT00535808|"~     In a prospective and randomized study protocol, three different blood pressure regulating~     agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect~     on the cerebral oxygen balance between both hemispheres during aortic coarctation repair.~     Cerebral and somatic saturation will be monitored non-invasively and continuously via optical~     sensors applied to the right and left forehead and the somatic regions. Arterial blood~     pressure, central venous pressure, heart rate and systemic saturation will be recorded~     continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6~     definite time intervals. The study ends at the end of the operation.~   "
230777|NCT00535795|"~     Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment~     of nasopharyngeal CA~   "
230778|NCT00535782|"~     This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness,~     and markers of atherogenic risk in patients with moderate to severe active rheumatoid~     arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab~     8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg~     weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus~     methotrexate.~   "
230779|NCT00535769|"~     The purpose of this study is to determine if using an electronic reminder improves adherence~     to sunscreen use. The specific study aims are as follows:~        1. To determine whether the use of electronic reminder system increases adherence to~          topical agents.~        2. To assess technological feasibility of measuring adherence to topical agents using~          electronic monitors specially designed for tubes.~        3. To assess technological feasibility of providing electronic reminders using cellular~          phone text-messaging system.~        4. To obtain subjects' feedback on the adherence monitoring and reminder system.~   "
230780|NCT00535756|"~     This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term~     safety data. During the long-term treatment with Creon 25000 nutritional parameters will be~     assessed and correlated with CFA~   "
230781|NCT00535743|"~     The objective of the trial was to explore the dose-response relation of Org 25969 given as a~     reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron®~     (rocuronium) in subjects of ASA 1 to 3, and to evaluate the safety of single doses of Org~     25969 administered to subjects of ASA 1 to 3.~   "
230782|NCT00535730|"~     The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal~     Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given~     together (in different body sites), as when they are given alone, in adults 60 years of age~     and older.~   "
230783|NCT00535717|"~     Uttarbasti is per urethral administration of medicated oil which has been recommended by~     Sushrut for urinary track disorders.~      As far as conventional surgery is concerned urethral stricture still remains a challenge due~     to post procedural high recurrences and complications~      Uttarbasti being almost non invasive, with minimum recurrences and most economical, easy to~     practice OPD procedure, can be the treatment of choice in the management of urethral~     stricture.~   "
230784|NCT00535704|"~     The Rural African American Families Health (RAAFH) Project is a federally funded research~     study designed to evaluate the effectiveness two prevention programs designed for rural~     African American families. One program, FUEL, helps teens develop lifestyles that prevent~     health problems such as heart disease, diabetes, and being overweight. This program deals~     with diet and exercise, the influence of TV and magazines on eating habits, and handling~     stress. The second program, the Strong African American Families Teen Program (SAAF-T), helps~     teens learn how to develop plans for the future and to avoid drug use and unsafe sex. The~     sessions deal with goal setting, peer pressure, and staying in school.~   "
230785|NCT00535691|"~     The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with~     atopic dermatitis after repeated application of tacrolimus ointment. Efficacy of tacrolimus~     ointment, evaluated by examination of treated areas, will also be measured.~   "
230786|NCT00535678|"~     To compare DBT and FFDM for screening effectiveness in women who present for screening~     mammography with respect to screening recall rate.~   "
230787|NCT00535665|"~     A single center, randomized and double-blind phase II clinical trial is to be conducted in~     adults to evaluate the safety and immunogenicity of an inactivated pandemic influenza vaccine~     (whole-virion, aluminium-adjuvanted).~   "
230788|NCT00535652|"~     The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue~     from three hours up to six hours (25% of dosing interval) after administration of ertapenem.~   "
230789|NCT00535639|"~     This trial is performed to assess the tolerability of the ALK Tree Tablet in patients with~     birch pollen induced allergy~   "
230790|NCT00535626|"~     The purpose of this study is to evaluate a hip implant system used when a previous hip~     replacement surgery has failed.~   "
230791|NCT00535613|"~     The purpose of the study is to see if a small dose of propofol given intravenously (through a~     needle into a vein) at the end of anesthesia can make it less likely that children will be~     agitated as the come out of the anesthetic.~   "
230801|NCT00535483|"~     The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients)~     aims to develop a low-risk monitoring and control device which allows maintaining metabolic~     control in intensive care units. A system will be developed comprising three subsystems: a~     body interface for the delivery of biofluids, biosensors for the determination of glucose~     concentration in these biofluids and an adaptive control algorithm that generates advice and~     thus represents a decision support system with respect to insulin infusion rate to establish~     glycaemic control in critically ill patients. Within a closed loop system, intensified~     insulin treatment will make use of the calculations leading to external regulation of~     glucose.~      It is the aim of this study to evaluate the feasibility to establish glycaemic control in~     type 1 diabetic subjects over a period of 30 hours by manually combining these three -~     previously tested - subsystems (ABS System, extracorporeal online glucose sensor and a~     laptop-based computer algorithm).~   "
230802|NCT00535470|"~     To evaluate the efficacy and safety of topical application of MCH 0.04% in a propylene glycol~     ointment (PG)in patients with stage I or IIA MF previously treated with MCH 0.02% in a PG or~     AP ointment who did not achieve a complete response.~   "
230792|NCT00535600|"~     This study, conducted at the NIH Clinical Research Unit (CRU) at the Phoenix Indian Medical~     Center, will compare the effects of two methods of bariatric surgery, the adjustable BAND and~     Roux-en-Y gastric bypass, on insulin. Bariatric surgery is a treatment for achieving and~     maintaining weight loss. The study will look at how this surgery might improve how insulin (a~     hormone important for regulating blood sugar levels) is made and works in the body and the~     possible role of changes in other hormones produced by the gut (stomach and intestines).~      People between 18 and 50 years of age who are scheduled to have either laparoscopic~     adjustable BAND or Roux-en-Y gastric bypass surgery may be eligible for this study.~     Candidates are screened about 4 to 6 weeks before their surgery with a medical history, blood~     tests and an oral glucose tolerance test for diabetes.~      Participants spend 4 days at the CRU or 2 days overnight and an out-patient visit~     approximately 4 to 6 weeks before their surgery and again 3 to 6 weeks after their surgery.~     They return for a 4-6 hour visit at the CRU at 6 months, 1 and 2 years after surgery and for~     half-day outpatient visits at 3, 4 and 5 years after surgery for the following procedures:~        -  Blood and urine tests, including a pregnancy test for women. (4-day and 2-day admissions~          and years, 3, 4 and 5)~        -  DEXA, an x-ray scan to determine body fat content. (4-day and 2-day admissions and~          years, 3, 4 and 5)~        -  MRI scan to measure fat tissue in the abdomen. (4-day and 2-day admissions and years, 3,~          4 and 5)~        -  Intravenous (I.V.) glucose tolerance test for risk of obesity and diabetes. A sugar~          solution is given through a needle in a vein of one arm and blood samples are drawn~          through another needle in a vein in the other arm. (4-day admissions)~        -  Meal test to measure blood sugar and insulin and gut hormone levels after a meal. After~          an I.V. line is placed in an arm vein, the subject eats breakfast over 20 minutes. Blood~          samples are collected halfway through the meal, at the end of the meal, and at 15, 30,~          60, 90, 120 and 180 minutes after completing the meal. Subjects fill out questionnaires~          on feelings of hunger and fullness before, during and after the meal test. (4-day and~          2-day admissions)~        -  Glucose clamp test to measure the effect on the body of insulin given through a vein. An~          I.V line is placed in a vein in the arm and in a vein of the hand on the other side of~          the body. While insulin is infused through one I.V., blood sugar levels are checked~          every 5 minutes and a sugar solution is given into a vein as needed. A radioactive sugar~          is also infused very slowly over 4 hours to determine how much sugar the body produces~          by itself. (4-day admissions)~   "
230793|NCT00535587|"~     The purpose of this trial was to test the combined and independent effects of 6 months of~     exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if~     Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms~     improved by the end of the trial.~   "
230794|NCT00535574|"~     Background: Bexarotene (Targretin) is a synthetic retinoid mainly used for treatment of~     patients suffer from oncological or dermatological diseases. The present study is based on:~     evidence that retinoids are involved in neurodevelopment (the retinoid dysregulation~     hypothesis); an assumption that the combined effect of antipsychotic agents and bexarotene~     will have a beneficial effect on schizophrenia patients; and the positive findings from our~     pilot open-label clinical trial (ClinicalTrials.gov Identifier: NCT00141947). However,~     clinical efficacy of bexarotene should be investigated in a placebo-controlled trial.~      Methods: In a 6-week, randomized, double-blind placebo-controlled trial Targretin (75 mg/day)~     or placebo capsules will be added to the stable ongoing antipsychotic treatment of 90~     schizophrenia patients. Participants will be assessed at baseline and after 2, 4 and 6 weeks~     of treatment. A battery of research instruments will be used for assessment of~     psychopathology, side effects, general functioning and quality of life. In addition,~     cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count~     will be monitored at baseline and during the study~   "
230795|NCT00535561|"~     To determine whether iron deficiency anemia can be an indication for the treatment of~     subclinical hypothyroidism.~   "
230796|NCT00535548|"~     Aim of the study:~      Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using~     a pressure sore model.~      Clinical relevance:~        -  Accelerated healing of uncomplicated wounds~        -  Enhanced healing of complicated (chronic, non-healing) wounds~      Study design:~        -  Prospective controlled phase I/II study~        -  Cohort of 5 patients in pilot study, then reevaluation~      Patients:~      - Para- and tetraplegic patients with sacral pressure sores grade III-IVA according to the~     classification of Daniel and Seiler~      Methods:~      1. First surgical intervention:~        -  Radical debridement of pressure sore~        -  Bone marrow harvest from the iliac crest~        -  Isolation of hematopoietic stem cells, aiming to gain > 1 mio. CD 34+ cells per patient~          under GMP conditions~           3. Stem cell therapy (after 2 days)~        -  Injection of stem cells in suspension (50'000 CD 34+ cells in 100 microliter saline per~          cm2 of wound surface) on one half of the total wound surface and cell-free saline on the~          other half as a control~           4. Second surgical intervention (after 3-4 weeks):~        -  Complete excision of the wound~        -  Closure of the defect by fasciocutaneous flap~           5. Evaluation of wound healing:~        -  Clinical~        -  3D laser imaging~        -  Histology~        -  Growth factor assay~   "
230797|NCT00535535|"~     Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin~     resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15~     overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride~     palmitate made by the liver from each single oral dose of fructose (0.5 g/kg),~     fructose:glucose 1:1 (1 g/kg) or fructose:glucose 1:1 (2 g/kg). Our hypotheses are that the~     synthesis of palmitate from dietary fructose will be 1) greater when consumed with glucose~     and 2) show a dose-response. The lipogenic responses will be compared and correlated with~     markers of carbohydrate and lipid flux measured after fasting and post-fructose. The results~     will serve as a guide to the development of a new outpatient probe of the de novo lipogenic~     pathway in subjects who vary in their lipogenic response to oral fructose. These studies~     should ultimately yield valuable new information about the mechanisms linking dietary~     carbohydrate to elevated triglycerides, diabetes and cardiovascular disease.~   "
230798|NCT00535522|"~     The purpose of this study is to determine the safety and pharmacokinetics of TAK-285 in~     patients with advanced cancer.~   "
230799|NCT00535509|"~     Phase II trial of Neoadjuvant [FEC100]/Cisplatin-Docetaxel ± Trastuzumab in women with over~     expressed or amplified Her2/Neu with Locally advanced Breast Cancer~   "
230800|NCT00535496|"~     The objective of the trial is to determine the relationship within a participant between the~     time to manual detection of the reappearance of the fourth twitch (T4) measured using a~     peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch~     (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex~     administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last~     maintenance dose of 0.15 mg/kg rocuronium.~   "
230820|NCT00535223|"~     The purpose of this randomized controlled trial is to determine if Group Based Exposure~     Therapy (GBET) is more effective than treatment as usual in reducing the symptoms of~     war-related Posttraumatic Stress Disorder (PTSD).~   "
230838|NCT00534989|"~     Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous~     Stem Cell Transplantation in Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease~   "
230803|NCT00535457|"~     It is not uncommon for children to undergo surgery. Surgery is a threatening event that is~     composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional~     response among operated children and their parents. In the current study we are going to~     examine if tricks done by the anesthesiologist before anesthetic induction are equally as~     effective as oral midazolam premedication in the reduction of pre-operative anxiety in~     children before and after surgery. A successful anxiety reduction may be advantageous over~     pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay~     and by reducing postoperative maladaptive behavior rate.~      Study hypothesis: 1. similar anxiety scores will be observed in children that will watch~     their anesthesiologist performing tricks and in those who will receive oral midazolam~     premedication but no tricks.~      2. Similar rates of postoperative maladaptive behavior will be found in children that that~     will see tricks and in those that will receive midazolam premedication.~   "
230804|NCT00535444|"~     Faith community nursing programs have grown out of churches as a response to the inequity of~     healthcare delivery to uninsured and underinsured communities. These programs provide~     outreach to community members and extend their services beyond just the parishioners of the~     churches, reaching more uninsured people than traditional medical services. Although faith~     community nursing programs have been established throughout the United States, no evaluation~     of these programs has been done. QueensCare is taking the lead in measuring the effect of~     parish nurses on health outcomes. In this project we have one specific aim: to measure the~     effect of parish nurse visits on blood pressure control on community-dwelling hypertensive~     patients. Our study will involve recruiting hypertensive patients from parish nurse led~     health fairs and interviewing subjects at the time of recruitment. Patients will either be~     randomized to parish nurse visits or primary care physician appointments. We will have a~     4-month follow-up period with a re-check of blood pressures and an exit interview of the~     patient. From this study, we hope to better understand if parish nurse visits improve blood~     pressure and medication compliance among hypertensive patients.~   "
230805|NCT00535431|"~     This is a single centre, double-blind, randomised, parallel group, repeated dose asthmatic~     subjects. Subjects will receive AER 001 (60 mgs) or placebo twice daily for 28 days. Before~     and after treatment subjects will be experimentally challenged with inhaled allergen to~     induce decreases in lung function. The primary outcome is late phase response to allergen as~     measured by the average percent change in FEV1 from 4-10 hours following allergen. Because~     AER 001 is a Th2 anti-inflammatory, it is hypothesized that AER 001 treatment will inhibit~     the late phase response to allergen challenge.~   "
230806|NCT00535418|"~     This study will assess optimal duration of pre-operative treatment with letrozole and to~     correlate clinical efficacy with appropriate surrogate markers.~   "
230807|NCT00535405|"~     A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus~     atorvastatin in elderly patients with high cholesterol at high or moderately high risk for~     coronary heart disease.~   "
230808|NCT00535392|"~     Keppra injection is approved in the US as adjunctive therapy in the treatment of partial~     onset seizures in adults with epilepsy. The objective of the current study is to assess the~     safety, tolerability, and pharmacokinetics, of this formulation in children aged 4 to 16~     years.~   "
230809|NCT00535379|"~     Clinical Part:~      The objective of this study is to determine the efficacy and safety of SUTENT in patients~     with recurrent or progressive glioblastoma multiforme.Patients with tissue based diagnosis of~     intracranial glioblastoma multiforme, above 18 years of age and of both genders, who have a~     first tumor recurrence or progress after surgery, radiation- and chemotherapy will be~     included. The hypothesis is that SUTENT will significantly increase the progression free~     survival rate at 6 months in the study population.~   "
230810|NCT00535366|"~     This efficacy and safety study compares four different combinations of blinded inhaled~     steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic~     obstructive pulmonary disease (COPD). The primary objective is the effect on lung function~     parameters.~   "
230811|NCT00535353|"~     RATIONALE: AZD2281 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as irinotecan, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving AZD2281 together with irinotecan may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of AZD2281 and~     irinotecan in treating patients with locally advanced or metastatic colorectal cancer.~   "
230812|NCT00535340|"~     The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a~     day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as~     assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A).~      Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly~     patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility~     and quality of life in elderly patients with GAD and to evaluate the tolerability and safety~     of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.~   "
230813|NCT00535327|"~     Comparison of the ability of DBT and FFDM to detect breast cancer.~   "
230814|NCT00535314|"~     The primary purpose of the study is to determine the proportion of patients without~     progression at 6-months in patients with unresectable Stage III or Stage IV melanoma who are~     taking RTA 402.~   "
230815|NCT00535301|"~     The purpose of this study is determine whether grafted anterior vaginal prolapse repair is~     more effective and associated with less complications than prolapse repair with suture.~   "
230816|NCT00535288|"~     To investigate efficacy and safety of 4 doses of esmirtazapine, compared to placebo, in the~     treatment of moderate to severe hot flushes (vasomotor symptoms) associated with the~     menopause. Co-primary efficacy endpoints are the frequency and severity of hot flushes after~     4 and 12 weeks as compared to Baseline.~   "
230817|NCT00535275|"~     Relapses after perioperative chemotherapy and surgery~   "
230818|NCT00535262|"~     This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a~     selegiline transdermal system (STS), in bipolar depression.~   "
230819|NCT00535236|"~     The proposed indication for the investigational heat-treated varicella-zoster virus (VZV)~     vaccine is the prevention of herpes zoster (HZ) and HZ-related complications in~     immunocompromised individuals.~   "
230821|NCT00535210|"~     This study would focus on adding a group exercise program to the usual therapy delivered in~     the hospital. We propose to design an exercise program that would be 30 minutes in length, 3~     times per week. A medical doctor and physiotherapist would oversee the design and monitoring~     of the program.~      We believe that this program will: 1) Increase the potential for better health, thus~     improving independence and quality of life; 2) Help people make the move from therapist run~     exercise to self management of exercise; 3) Engage the patient in the therapy process and~     place an expectation of active participation on the client; and 4) Promote physical activity~     as part of a healthy lifestyle.~   "
230822|NCT00535197|"~     The aim of the study is to determine the safety and tolerability of an autologous CD34+~     subset bone marrow stem cell infusion into the middle cerebral artery in patients who have~     suffered acute total or partial anterior circulation syndrome (TACS/PACS).~   "
230823|NCT00535184|"~     Comparison of the ability of DBT and FFDM to detect breast cancer.~   "
230824|NCT00535171|"~     To determine the effect of an interventional campaign run by a dedicated VTE Nurse Educator~     over a 6-month period and the effect on prophylaxis rates.~      To determine the proportion of medically admitted patients with risk factors for VTE.~      To assess and compare the use of venous thromboembolism (VTE) prophylaxis in hospitalized~     medical patients versus recommendations and current guidelines.~      To determine the patient characteristics of those deemed to be at risk of VTE. To determine~     the proportion of patients receiving appropriate thromboprophylaxis for their risk.~      To determine the type and duration (where possible) of prophylaxis used.~   "
230825|NCT00535158|"~     Vitamin D is necessary for healthy bones. Vitamin D is made in our skin when we are exposed~     to sunlight, but it is also found in foods that we eat and in vitamin pills. Low levels of~     vitamin D are common in many groups of people, because we do not get enough sun during the~     winter and because we eat few foods that have vitamin D in them. Some foods with vitamin D~     are salmon, mackerel, tuna, and fortified milk, which has had vitamin D added to it.~      We know that nearly all kidney disease patients on dialysis do not have enough vitamin D in~     their bodies. We believe this condition can cause muscle weakness, leading to falls and~     broken bones. These are common problems for patients who are receiving dialysis. For example,~     dialysis patients have a much higher risk of hip fractures (broken hips). However, no formal~     research has been done on patients with low vitamin D levels receiving dialysis, to see if~     they actually have muscle weakness and related problems.~      There are two goals of this study. First, we want to see if patients on dialysis who have low~     vitamin D levels are actually at risk for muscle weakness, muscle pain, and broken bones. We~     also want to find out if giving vitamin D pills to these patients will result in better~     muscle strength, less muscle pain, and fewer falls.~      In this study, we will compare vitamin D to placebo. Placebo capsules look exactly like~     vitamin D capsules but contain no active ingredients. We use placebos in research studies to~     be sure that the study results are due to the study drug and not to other reasons.~   "
230826|NCT00535145|"~     The purpose of this study is to evaluate the tolerability and safety of paliperidone ER~     (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the~     treatment of patients with schizophrenia or schizoaffective disorder and liver disease.~   "
230827|NCT00535132|"~     The purpose of this study is to evaluate medication satisfaction after at least 4 weeks of~     paliperidone ER (extended-release), an antipsychotic, treatment in patients with~     schizophrenia who were previously taking either 4 or 6 mg of risperidone daily by mouth, but~     who are not satisfied with their treatment.~   "
230828|NCT00535119|"~     This phase I trial is studying the side effects and best dose of veliparib when given~     together with carboplatin and paclitaxel in treating patients with advanced solid cancer.~     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving veliparib together with carboplatin and paclitaxel may help kill more tumor~     cells.~   "
230829|NCT00535106|"~     This study is designed to examine the impact of an available technology within an automated~     external defibrillator (AEDs) to improve survival following out-of-hospital cardiac arrest~     for patients presenting in ventricular fibrillation.~   "
230830|NCT00535093|"~     There is a large over-use of antibiotics in family medicine, especially in upper respiratory~     tract infections.~      This study is designed to determine if the use of rapid Streptococcal tests in primary care~     clinics can lower the rate of antibiotic use while not missing bacterial infections.~   "
230831|NCT00535080|"~     The aim of this study is to provide this investigational drug to patients who cannot be~     optimally treated with conventional therapies and to collect efficacy and safety data on the~     use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal~     cell carcinomas (BCCs) or Bowen's disease.~   "
230832|NCT00535067|"~     The objectives of this study are to: 1) describe the prevalence of neuropathic pain (NP) in~     breast cancer survivors and 2) to develop preliminary statistical risk models for predicting~     the risk for NP incorporating disease-related variables (e.g., stage of disease, location of~     tumor), treatment variables (chemotherapy, dose, duration; and other cancer therapy),~     clinical health status (e.g., comorbid conditions), and sociodemographic characteristics~     (e.g., age, sex, race).~      Researchers will also gather data to answer the following secondary aims:~        1. To assess the impact of NP on quality of life.~        2. To assess the current management of NP in cancer (current medication, duration of such~          treatment, reasons for discontinuation) and the outcomes of this management.~   "
230833|NCT00535054|"~     The purpose of this study is to determine safety and patients' satisfaction when using Tears~     Again to treat Dry Eye Symptoms.~   "
230834|NCT00535041|"~     Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite~     surgery in patients with localized rectal CA~   "
230835|NCT00535028|"~     This is a single center, double-blind, randomised parallel group design study to investigate~     the effects of AER 001 on the late phase asthmatic resonse in asthmatic subjects. AER 001 is~     to be administered subcutaneously (25 mg, once daily) for 28 days. The asthmatic subjects~     will be challenged with allergen both before and after AER 001 treatment (at screen and at~     Day 28). The primary outcome will be late phase sthmatic response (the max drop in FEV1 from~     4-10 hours after an allergen challenge).~   "
230839|NCT00534976|"~     This study will see if there is a change in breathing after exercising when the child~     receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer~     before exercising and measured again several times after exercising.~   "
230840|NCT00534963|"~     The primary objective of this investigation was to evaluate if the location of placement of~     the SIS balloon into either the uterine cavity or the cervical canal affected discomfort~     perceived during the examination.~   "
230841|NCT00534950|"~     Randomized multicenter study of 5 vs 6 weekly fraction of RT in the treatment of SCC of the~     head and neck~   "
230842|NCT00534937|"~     The researchers hypothesize that utilization of the Flexitouch system will improve the~     healing rates of (venous stasis ulcers) VSU compared to traditional compression wrapping~     therapy alone.~      Primary Objective: The primary study objective is to determine whether the complete healing~     rate of venous stasis ulcers at 12 weeks is improved by the addition of Flexitouch® System~     compression therapy to a standard regimen of compression wrapping.~      Secondary Objectives:~        -  To determine whether the addition of Flexitouch System compression therapy to a standard~          regimen of compression wrapping increases the percentage reduction in wound surface~          area.~        -  To determine whether the addition of Flexitouch compression therapy to a standard~          regimen of compression wrapping increases the percentage reduction in volume of the~          affected limb.~        -  To determine whether the addition of Flexitouch compression therapy to a standard~          regimen of compression wrapping decreases the time to healing of the venous stasis~          ulcer.~   "
230843|NCT00534924|"~     Ischemic injury to muscular tissue is common in cardiovascular medicine. The most effective~     treatment to avoid ischemic damage is the rapid re-establishment of reperfusion. However,~     reperfusion itself can result in additional damage to ischemic tissue. This phenomenon is~     called ischemia - reperfusion (IR) injury and is caused by different pathologic mechanisms.~      Therapies are required which can be administered after the onset of an ischemic event to~     protect the tissue against IR injury. Therefore, a promising strategy to reduce IR injury is~     post-conditioning.~      Likewise, pharmacological therapies administered after the onset of reperfusion might prevent~     tissue injury. We have recently shown that high concentrations of exogenous vitamin C~     abrogate experimental IR injury of the forearm vasculature in patients with peripheral artery~     disease and in healthy subjects.~      Study hypothesis~      We hypothesize that the administration of mechanical post-conditioning or of high-dose~     vitamin C may protect skeletal muscle against IR injury. This shall be studied employing MR~     spectroscopy of the leg, which is an established model to assess muscle aerobic energy~     metabolism.~      Design~      Three periods, three way cross over study in 10 volunteers. One screening visit, three~     one-day study days with two washout periods of >3 days in between are scheduled for each~     participant. The order of experimental days will be randomized. After the last treatment a~     final follow-up examination will be performed within one week.~   "
230844|NCT00534911|"~     Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive~     symptoms and more trouble with daily functioning than those without physical illness. The~     proposed study will investigate if cognitive behavioral therapy (CBT) is better than~     supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth~     ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also~     assess the effect of CBT on IBD-related factors such as disease severity, medication~     adherence, and physical-health related quality of life.~      Hypothesis~      - Individuals who receive CBT will show more improvement than individuals who receive SNDT.~   "
230845|NCT00534898|"~     Background: In this proposed study, we aim to investigate safety and efficacy of two~     synthetic retinoids - bexarotene (Targretin; LGD1069;~     4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) and~     fenretinide (Dihydroceramide N-(4-Hydroxyphenyl retinamide) on severity of psychopathology~     and cognitive impairment in schizophrenia patients in an double-blind, placebo-controlled~     study. The rationale behind add-on these medications to ongoing antipsychotic treatment in~     schizophrenia patients is based on both the retinoid dysregulation hypothesis: the growth~     factors deficiency and synaptic destabilization hypothesis of schizophrenia. Furthermore, in~     our preliminary open clinical trial, we found that a low dose of bexarotene (Targretin, 75~     mg/day) was safe and led to significant improvement on total PANSS scores, general~     psychopathology, on the positive and the dysphoric mood factor scores. The aim of the present~     study was to provide further insight into the safety and efficacy of bexarotene in comparison~     to fenretinide (a medication with smaller potential of adverse effects) and placebo in~     patients suffered from schizophrenia.~   "
230846|NCT00534885|"~     A double-blind, randomized and controlled clinical trial was conducted in healthy children~     aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of~     a preservative-free inactivated hepatitis A vaccine (Healive®).~      Participants who completed their primary vaccination were invited to participate in the~     follow-up phase. Written informed consents were obtained from them. The follow-up study was~     open-label. These subjects were visited annually in the next 5 years for blood sampling and~     assessment of immune persistence induced by vaccination.~   "
230847|NCT00534872|"~     The purpose of this study is to determine the blood levels and the tolerability of SB-649868~     in Elderly and Female population~   "
230848|NCT00534859|"~     The objective of this feasibility study is to demonstrate that the device is safe and~     potentially efficacious for use in patients undergoing high risk Percutaneous Coronary~     Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.~   "
230849|NCT00534846|"~     The purpose of this study is to determine the effect of toremifene treatment to the MRI~     findings of the breast in women suffering from premenstrual mastalgia.~   "
230850|NCT00534833|"~     The present trial is a follow-up of AL203 study (NCT00343889).~      Primary Objectives:~      To describe the antibody persistence at 15 to 18 months of age and the booster effect of a~     dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine~     [OPV]).~      Secondary Objective:~      To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ when~     administered concomitantly with OPV in each vaccine group.~   "
230851|NCT00534820|"~     Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous~     Stem Cell Transplantation in Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease~   "
230854|NCT00534781|"~     This is a research study to evaluate the outcomes after the study procedure for pain and~     discomfort in the heel caused from an injury in the Achilles tendon which is located on the~     back of the foot (commonly called Achilles tendinitis-Achilles tendinosis) that has not~     gotten better with medicine and/or other therapy.~      Researchers want to see if using the study device changes outcomes for 1 year after the study~     procedure.~   "
230855|NCT00534768|"~     Objective: Even though postoperative debridement is commonly considered as an essential part~     of endoscopic sinus surgery (ESS), the scientific data on the efficacy or the optimal timing~     of debridement is limited. In the present study, the effect of repeated debridement during~     the first week after ESS on the endoscopic and subjective outcome was evaluated.~      Study Design: Open, prospective, randomized, controlled clinical trial with two parallel~     groups.~      Methods: A total of 90 patients suffering from either recurrent or chronic maxillary~     sinusitis were randomized into two groups after ESS. In the active group, the nasal cavities~     were debrided three times on the first postoperative week, while in the control group the~     patients were debrided only once on the 7th postoperative day. The primary outcome measure~     was the presence of scarring in the middle meatus at four weeks after ESS.~   "
230856|NCT00534755|"~     Prospective & Retrospective data collection of breast cancer cases from 2000 to present~   "
230857|NCT00534742|"~     The exact etiology of ischemic stroke remains unclear, because multiple genetic~     predispositions and environmental risk factors may be involved, and their interactions~     dictate the complexity. Family-based studies provide unique features in design because of~     their robustness to population admixture and stratification. The Fangshan / Family-based~     Ischemic Stroke Study In China (FISSIC) program aims to conduct a genetic pedigree study of~     ischemic stroke in rural communities of China.~   "
230858|NCT00534729|"~     Organ Preservation: Weekly Carboplatin & Taxol w/concurrent RT for locally advanced laryngeal~     & Hypopharyngeal CA~   "
230859|NCT00534716|"~     The purpose of this study on volunteers is whether THC and short-living metabolites are~     suited to detect recent Cannabis smoking within urine doping control.~   "
230860|NCT00534703|"~     The aim of the study is to determine the safety and feasibility of giving an adeno-associated~     viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the~     CMV promoter (AAV1-CMV-SERCA2a), to heart failure patients that have received a left~     ventricular assist device (LVAD) for an accepted clinical indication. It is a randomised,~     double-blind study of 24 patients that will be randomised to receive either the study drug~     (AAV1.SERCA2a) or placebo.~      The purpose of gene transfer of SERCA2a is to improve systolic and diastolic function of the~     failing ventricle. Studies show that reduction of SERCA2a in failing ventricle is a key~     factor in depression of contraction, and that restoration of SERCA2a levels can improve~     function to near normal levels. The vector will be delivered during a cardiac catheterisation~     procedure by a 10-minute infusion into the coronary arteries.~      Myocardial tissue is obtained at the time of LVAD placement, as a routine part of device~     implantation. Further samples will be obtained when the heart is transplanted or the LVAD~     removed. Measures of tissue inflammation as well as efficacy of gene transfer will be made by~     comparing these two samples. Recovery of contractile function of the heart will be assessed~     during attempts to wean patients from the LVAD using standard protocols.~      The results will be assessed in conjunction with two companion studies which will start~     earlier in the US, one performing SERCA2a gene transfer with the same vector, but delivered~     by direct injection into the myocardium during LVAD insertion, and one using AAV1-CMV-SERCA2a~     delivered percutaneously in heart failure patients. The latter has both a dose-ranging and~     placebo-controlled arm.~   "
230861|NCT00534690|"~     During general anesthesia, airway closure and the formation of atelectasis impair~     oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis~     with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The~     reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar~     derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the~     impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar~     recruitment when TV is reduced.~   "
230862|NCT00534677|"~     Terlipressin and Octreotide are two common agents used as adjuvants in the management of~     variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in~     randomized studies. There are no head to head clinical trials of these two agents available~     in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide~     in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with~     Esophageal Variceal Bleed (EVB).~   "
230863|NCT00534664|"~     The goal of this study is to investigate the safety and feasibility of treating patients with~     advanced hepatocellular carcinoma with a noninvasive device administering low level of~     amplitude-modulated electromagnetic fields.~   "
230864|NCT00534651|"~     The purpose of this study is to determine the effect of orally given paracetamol on the~     vascular function and on 24-hour blood pressure in patients with coronary artery disease~   "
230865|NCT00534638|"~     Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and~     women. The most important disease associated with oncogenic HPV infection is cervical cancer,~     currently the second leading cause of cancer-related death among women globally. The current~     study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15~     years of age.~      This protocol posting has been updated following protocol amendment 09, 24 March 2014. The~     sections impacted are secondary objectives, endpoints, final analyses.~   "
230866|NCT00534625|"~     A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients~     with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid~     increase in FEV1/PEFR and when this effect can be seen. The safety of this route of~     administration of zileuton will also be studied. PK will be obtained in a population based~     method.~   "
230867|NCT00534612|"~     Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All~     information regarding this procedure has been retrospective. Our objective is to evaluate~     prospectively the diagnostic accuracy of the test, alone and when associated to clinical~     and/or radiologic data.~   "
230921|NCT00533897|"~     The purpose of the study is to determine whether subcutaneous abatacept administered to~     patients with rheumatoid arthritis is associated with increased immunogenicity or increased~     safety events upon withdrawal and reintroduction.~   "
230868|NCT00534599|"~     This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL)~     when added to standard selective serotonin reuptake inhibitor (SSRI) /~     serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the~     treatment of Generalized Anxiety Disorder in patients with partial or no response to~     SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with~     placebo~   "
230869|NCT00534586|"~     The aim of the present study is to investigate and quantify the influence of commonly used~     anesthetics on auditory and pain evoked potentials.~   "
230870|NCT00534573|"~     Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable~     adverse effect of clozapine therapy, and until now there is not enough effective treatment~     for this side effect leading to noncompliance.~      In previous studies it was found that substitute benzamide derivatives with higher selective~     binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in~     treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in~     Israel, there are four medications which belong to substitute benzamide derivatives group:~     amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect~     is universal for the whole group of benzamide.~      The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible~     monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an~     additional possibility for management of CIH.~   "
230871|NCT00534560|"~     Primary objective:~      To investigate the efficacy and tolerability of two doses of tonabersat compared to placebo~     in the prophylaxis of migraine headache and to evaluate the longer term tolerability of~     tonabersat in an open label extension.~      Secondary objective(s):~      To obtain further data on the efficacy and dose response of tonabersat; To extend the safety~     and tolerability database of tonabersat; To obtain data on the pharmacokinetics of~     tonabersat.~   "
230872|NCT00534547|"~     The purpose of this study is to investigate the role of an experimental surgery that may~     offer better short and long-term control of T2DM in select patients who have not achieved~     adequate blood sugar control with regular means.~   "
230873|NCT00534534|"~     Retrospective studies have shown, that about half of the patients will have a recurrent~     episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than~     half annually are treated for recurrent acute pancreatitis. Because alcohol has been shown an~     important factor in the development of recurrent pancreatitis, it was hypothesized, that by~     attempting intensively to diminish the individual alcohol consumption the number of recurrent~     pancreatitis could be decreased. Two protocols will be compared: A) initial intervention~     against alcohol abuse and B) repeated interventions at 6 month intervals.~   "
230874|NCT00534521|"~     The overall goal of this research is to determine the efficacy of a sham for posterior tibial~     nerve stimulation (PTNS). This novel design is needed in order to have a sham treatment that~     is similar to the actual treatment. The PTNS is used to treat urgency and frequency in people~     with overactive bladder (OAB). Until research is done using a sham component, we are unable~     to ascertain if the current use of PTNS is due to a placebo effect.~   "
230875|NCT00534508|"~     This study was designed to further increase the understanding of the pharmacokinetics of~     tacrolimus in the affected skin of atopic dermatitis patients following repeated topical~     application of tacrolimus ointment 0.1%.~   "
230876|NCT00534495|"~     Systemic juvenile idiopathic arthritis (SJIA) is a type of arthritis that typically occurs~     before 16 years of age. SJIA usually involves heat, pain, swelling, and stiffness in the~     body's joints. It can also involve fever, rash, anemia, and inflammation in various parts of~     the body. Rilonacept is a drug that can reduce inflammation. The purpose of this study is to~     determine whether a rilonacept drug regimen initiated early is more effective than a similar~     rilonacept drug regimen initiated 4 weeks later when treating children and young adults with~     SJIA.~   "
230877|NCT00534482|"~     This research project brings together the American Academy of Family Physicians (AAFP)~     National Research Network (AAFP-NRN) and the AAFP's public health initiative, Americans In~     Motion (AIM). This project will develop and evaluate a practice improvement program to~     improve family physicians' delivery of effective patient-centered behavior change~     interventions for fitness (physical activity, nutrition and emotional well-being). The~     investigators seek to develop a unique program that positions fitness in a central role as~     the treatment of choice when dealing with issues of prevention and treatment of chronic~     conditions. In addition, this newly developed program is intended to help shift the paradigm~     of family physicians' use of common advice-giving methods to more effective patient-centered~     lifestyle counseling. Ultimately, this program will seek to improve care for all patients~     through fitness-related physician interventions.~      Outcomes: This study design will allow the investigators to evaluate whether (and how)~     dissemination of educational materials impacts patient intervention by first engaging~     clinicians and staff in their personal use of these materials. This project will also~     evaluate the effects of the behavioral change tools, as well as, the added impact of new~     physiologic feedback measures (HOMA-IR and NMR Lipoprotein profiles) on physical activity and~     diet in study participants.~      Conclusion: Primary care offices can become more effective settings to help patients improve~     physical activity, diet and emotional well-being. Demonstrating the value and impact of~     creating healthy offices that endorse and support clinicians, office staff and patients in~     the use of effective educational materials fits well with the new model of care as part of~     the AAFP's Future of Family Medicine initiatives, which emphasize the importance of~     lifestyle decisions and supporting successful changes in behaviors within primary care. This~     project will help define how to accomplish this.~   "
230878|NCT00534469|"~     RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of~     cancer cells by stopping them from dividing or killing them. After treatment, stem cells are~     collected from the patient's blood and/or bone marrow and stored. More chemotherapy and~     radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem~     cells are then returned to the patient to replace the blood-forming cells that were destroyed~     by the chemotherapy and radiation therapy. Giving aldesleukin after transplant may help keep~     cancer cells from coming back after transplant.~      PURPOSE: This phase II trial is studying the side effects and how well giving busulfan and~     etoposide together with total-body irradiation followed by autologous stem cell transplant~     and aldesleukin works in treating patients with acute myeloid leukemia in first remission.~   "
230879|NCT00534456|"~     The purpose of Study 20060172 was to measure echocardiographic parameters and biomarkers in a~     subgroup of study subjects enrolled in Study 20050222 (the RED-HF Trial). This substudy~     20060172 was terminated early due to feasibility constraints. All subjects enrolled in~     20060172 were also enrolled in Study 20050222, which is ongoing. Study data will be analyzed~     when Study 20050222 ends, since unblinding before then would adversely affect Study 20050222.~   "
230956|NCT00533442|"~     This study was designed to determine which maintenance immunosuppressive agent, rapamycin or~     mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal~     failure, who presented for a kidney-pancreas transplant.~   "
230880|NCT00534443|"~     Although all PPIs are effective, there are some differences in their clinical performance,~     particularly in terms of the degree and speed of gastric acid suppression. Few data are also~     available about their effect of the pathophysiological mechanisms of gastritis and peptic~     ulcer disease. Aim of the present study is to investigate the effect of therapy with~     esomeprazole or rabeprazole on the mechanism of pathogenesis of gastritis and particularly on~     the pattern of release of pro- and anti- inflammatory cytokines associated to peptic~     ulcerative process by the gastric mucosa.~   "
230881|NCT00534430|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant~     or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and~     helps stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from~     happening.~      PURPOSE: This phase II trial is studying the side effects and best way to give busulfan~     together with etoposide and total-body irradiation and to see how well they work in treating~     patients who are undergoing a donor stem cell or bone marrow transplant for advanced~     hematologic cancer.~   "
230882|NCT00534417|"~     The purpose of this study is to determine if the combination of continuous daily capecitabine~     with fulvestrant on a loading dose schedule will delay disease progression in metastatic~     breast cancer (MBC) patients.~   "
230883|NCT00534404|"~     People who smoke cigarettes have an increased risk of developing emphysema, heart disease,~     and certain types of cancer. This study will evaluate the effectiveness of providing free~     nicotine patches from an online smoking cessation program, with and without telephone~     counseling, at improving quit rates in cigarette smokers.~   "
230884|NCT00534391|"~     To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate,~     polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of~     hordeolum after incision and curettage~   "
230885|NCT00534378|"~     Purpose of the study is to determine midazolam's safety and dose-linearity when delivered~     intramuscularly via an autoinjector. The proposed initial treatment dosage for seizures~     induced by exposure to nerve agents.~   "
230886|NCT00534365|"~     The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal~     tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary~     incontinence.~   "
230887|NCT00534352|"~     The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with~     tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with~     and without darunavir/ritonavir 800/100 mg once daily in HIV-1 infected, antiretroviral (ARV)~     naÃ-ve patients (patients who have never received ARV treatment).~   "
230888|NCT00534339|"~     Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable~     gastric banding device for the treatment of morbidly obese patients.~   "
230889|NCT00534326|"~     Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of~     intramedullary nails for the fixation of long bone fractures. This study is designed to~     compare the union rates between fractures reamed by standard reaming versus reaming with a~     Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based~     outcomes on these patients. Little information exists on the patient based outcomes following~     femur fractures. We hope that the patient based outcomes of this study will also be able to~     aid physicians in advising patients with femur fractures of their possible outcomes.~   "
230890|NCT00534313|"~     The purpose of this study is to determine an optimal abatacept dosing regimen for the~     treatment of active arthritis due to psoriatic arthritis in patients who have had a prior~     inadequate response to disease-modifying antirheumatic drugs, including methotrexate and~     tumor necrosis factor alpha-blockade compounds.~   "
230891|NCT00534300|"~     The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and~     docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and~     ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into~     cellular membranes after regular ingestion of fatty fish or fish oil.~      This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on~     inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker.~      The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase~     the electric stability of the myocardial cells, so that VT is more difficult to induce.~      In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a~     high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously~     before a non-invasive electrophysiologic examination performed via the ICD and following a~     predefined protocol.~      The main outcome is inducibility of VT. If sustained VT is induced in a patient after both~     n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo~     is compared.~   "
230892|NCT00534287|"~     Severe sepsis and septic shock are diseases of infectious origin with a high risk of death.~     Antibiotic therapy is mandatory but it is unknown whether one antibiotic alone is sufficient~     for initial therapy. The purpose of this study is to compare a therapy with meropenem alone~     or the combination of meropenem plus moxifloxacin in the treatment of severe sepsis/ septic~     shock. Patients randomly receive one of the two treatments for at least 7 days but not longer~     than 14 days.~   "
230893|NCT00534274|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using~     3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy~     before surgery in treating locally advanced breast cancer.~      PURPOSE: This clinical trial is studying how well positron emission tomography using~     3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one~     breast who are receiving chemotherapy.~   "
230894|NCT00534261|"~     This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated~     with Interferon beta-1a had an improved quality of life after treatment with Interferon~     beta-1a~   "
230895|NCT00534248|"~     This study will look at how well Zostavax™ works in preventing shingles in participants ages~     50-59 years old.~   "
230896|NCT00534235|"~     Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs.~     Fusion to Treat Lumbar Spinal Stenosis~   "
230897|NCT00534222|"~     With this observational study we want to examine if the intensity of agitation, the intensity~     of psychotic symptoms and the presence of sleeping disorder predict the success of the~     treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a~     psychotic and/or manic episode. In this study it will be examined what the percentage of~     patients with a 2-point improvement at the CGI-scale is. Of these group, the responders,~     retrospective the profile of the responders will be analysed (key-factors and confounders).~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
230898|NCT00534209|"~     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune~     response to kill tumor cells.~      PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and~     to see how well it works in treating patients with stage IIIB or stage IV non-small cell lung~     cancer who have finished first-line chemotherapy.~   "
230899|NCT00534196|"~     RATIONALE: Implant radiation therapy delivers a high dose of radiation directly to the tumor~     may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This clinical trial is studying the side effects and how well implant radiation~     therapy using radioactive iodine works in treating patients with localized prostate cancer.~   "
230900|NCT00534183|"~     No clinical differences will be found between the three antipsychotics under study -~     olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. ~   "
230901|NCT00534170|"~     A therapeutic as well as preventive role of probiotics has been suggested from results of~     different studies using different probiotics that have been tested, usually lactic acid~     producing bacteria such as lactobacillus, bifidobacterium and streptococcus species. The~     supplementation of probiotics to infants may also have a prophylactic effect against acute~     diarrhoeal diseases.~      In the present proposal, we plan to examine if daily intake of a probiotic beverage, which~     includes 15 billion probiotic Lactobacilli, has a beneficial role in protecting children from~     infectious diarrhea in Kolkata.~      OBJECTIVES~      Primary objectives:~        1. To assess the impact of probiotics in the prevention of acute diarrhoeal diseases in~          children~        2. To assess the impact of probiotics on nutrition and growth of the children~      Secondary Objectives:~        1. Reduction in duration, frequency of diarrhoea~        2. Identification of pathogens causing diarrhoea~        3. Examination of faecal microflora~      STUDY DESIGN~      It will be a double blind randomized controlled field trial involving 4000 children aged~     between 1 and 5 years in an urban slum of Kolkata, India. The 4000 children will be~     identified through demographic survey. The study will be double blinded where the study arm~     will receive Probiotic drink, which includes 15 billion probiotic Lactobacilli, one bottle~     (65ml) daily (under supervision of a Health Worker) for 12 weeks and the control arm will~     receive a similar drink without the lactobacilli (Nutrient drink) daily for 12 weeks.~     Randomization will be done in a ratio of 1:1, i.e., the study arm and control arm will~     include 2000 children each. All the children under the study will be visited daily by a~     health worker who will supervise intake of Probiotic drink or Nutrient drink by the children.~     All the children will be followed up daily for 24weeks for identification of acute diarrhoea~     cases.~   "
230902|NCT00534157|"~     The purpose of this study is to determine if the pressure in the eye of a severely~     head-injured person correlates with the pressure in the person's skull. This is a prospective~     study of patients aged 18 and older who have experienced a traumatic closed head injury and~     are intubated either before or during the time they are in the Emergency Department (ED).~     Identified patients have an eye pressure measurement performed in the trauma bay by an OSU ED~     physician not involved in their care. Information about their hospital stay, including the~     first brain pressure measurement if a such a measuring device is used, will be collected. In~     addition, the outcome of their hospital stay will be recorded.~   "
230903|NCT00534144|"~     This study will compare the effects of sodium ferric gluconate complex and iron sucrose on~     urine concentrations of various chemicals including protein~   "
230904|NCT00534131|"~     Anal sphincter preserving operations are now commonplace for both cancer and non-cancerous~     rectal diseases. However, this has not always been the case and this development has been~     facilitated by the invention of circular stapling instruments, which allow the bowel to be~     reconnected to the anal sphincters, where it would almost be impossible to do so manually.~     Nevertheless, some patients still require a permanent ostomy, as even with stapling devices~     ultra low joins of the bowel and sphincter muscles cannot always be performed by a~     conventional surgery. Therefore, a variety of alternative techniques have been proposed to~     avoid a permanent ostomy, but these have not become widespread due to the technical~     difficulty in performing them, their failure to completely eradicate rectal disease, and the~     damage they inflict upon the anal sphincters resulting in poor bowel function after surgery.~      The ideal ultra low sphincter preserving operation should remove the rectal disease entirely,~     allow the small or large bowel to be safely joined to the anal sphincters under direct~     vision, and retain the sphincter mechanism in its entirety. We propose such a technique that~     we term the APPEAR procedure, which approaches the lower third of the rectum via an incision~     between the scrotum or vagina, and the anal sphincters. This procedure preserves sphincter~     integrity, and allows either a stapled or manual join of the bowel to the sphincter~     mechanism, under direct vision. This trial is being conducted as a pilot study, with the~     procedure only offered to patients for whom a conventional sphincter saving procedure was~     technically impossible, or contraindicated.~   "
230905|NCT00534118|"~     RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in~     patients with hematologic cancer that has come back after a donor stem cell transplant.~      PURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating~     patients with recurrent or persistent hematologic cancer after donor stem cell transplant.~   "
230922|NCT00533884|"~     RATIONALE: Gathering information about how often problems with neurocognitive functioning~     occur in patients with newly diagnosed upper aerodigestive tract cancers may help doctors~     learn more about the disease.~      PURPOSE: This clinical trial is studying neurocognitive functioning in patients with newly~     diagnosed upper aerodigestive tract cancers receiving treatment at Henry-Joyce Cancer Clinic.~   "
230923|NCT00533871|"~     Preeclampsia is a common disease state occurring in the third trimester of pregnancy, with an~     incidence of approximately 5-10% in the US. Hypertension (high blood pressure), a primary~     symptom of pre-eclampsia, may be present in women who were hypertensive prior to becoming~     pregnant.B-type (also known as brain) natriuretic peptide (BNP) is known to be made and~     released from the heart ventricles when the heart is strained. There is also evidence that~     BNP is secreted in the placenta, and may increase in preeclampsia and chronic hypertension in~     pregnancy.The purpose of the study is to determine if a maternal blood sample analyzed for~     the quantity of BNP is helpful in differentiating between pre-eclampsia and chronic high~     blood pressure.~   "
231011|NCT00532714|"~     To evaluate the response rate of capecitabine and irinotecan combination therapy in patients~     with metastatic breast cancer~   "
230906|NCT00534105|"~     The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an~     exaggerated lipid response compared to non-gestational diabetics. If a difference is noted,~     further studies will explore the possibility of screening gestational diabetics during their~     pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk~     for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction~     and placental disease will be explored.~      This will be a prospective cohort study. As part of routine prenatal care, women receive a~     one hour glucose challenge test to screen for gestational diabetes. Those women with elevated~     values then require a three hour glucose tolerance test, which is a diagnostic test for~     gestational diabetes. All women that are scheduled to receive a three hour GTT will be~     identified and ask to enroll in this study. 46 women whose three hour GTT is normal and thus~     do not have GDM, will be compared to 46 women with an abnormal three hour GTT and thus would~     have the diagnosis of GDM. Enrolled women will have a lipid panel consisting of; total~     cholesterol, triglycerides, HDL and LDL cholesterol at the time of their fasting glucose~     blood sample. In addition, a repeat lipid panel will be sent at the time of the third hour~     sample, to assess changes, if any due to the glucose challenge. Umbilical cord blood samples~     will be sent in order to obtain newborn lipid profiles. Women in both the GDM and normal~     groups will be asked to return 6-8 weeks~   "
230907|NCT00534092|"~     The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all~     patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol~     (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and~     effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of~     patients with moderately impaired physical function who elect to undergo X-STOP surgery.~   "
230908|NCT00534079|"~     Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality~     of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a~     dysfunction of chloride channels in exocrine glands, leading to retention of secretions and~     consecutive chronic inflammation with bacterial superinfections.~      The prospective placebo controlled cross-over study aims at the evaluation of a nasally~     inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.~   "
230909|NCT00534066|"~     The purpose of the study is to determine if a series of BNP blood tests performed on patients~     who present to the Emergency Department with congestive heart failure (CHF) can predict which~     patients may have adverse outcomes. If the BNP is shown to be predictive of bad outcomes in~     certain patients, those patients might receive more intensive therapy early to prevent such~     outcomes. This was a prospective trial enrolling patients who presented to the ED and were~     diagnosed with heart failure. Subjects had a blood test for BNP, which is elevated in the~     presence of heart failure, collected twelve hours after their initial clinical BNP was~     obtained in the ED. Demographics, history, length of hospital stay, and other approved data~     were collected. At 30 days and 6 months after discharge, a follow up call was made to~     determine if the subject had required additional emergency care, had been admitted to a~     hospital, or had died during that period of time.~   "
230910|NCT00534053|"~     The purpose of our randomized controlled trial is to determine whether mailed educational~     reminders would increase fecal occult blood test (FOBT) card return rates and, therefore,~     improve patient compliance with colonrectal cancer (CRC) screening.~      We will conduct a randomized, controlled trial to evaluate the hypothesis that compliance to~     FOBT referrals is at least 10% greater among patients who receive mailed educational~     reminders on the importance of CRC screening. The study will be conducted in Veteran Affairs~     Medical Center and surrounding VA clinics in San Diego.~   "
230911|NCT00534027|"~     Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled,~     phase 2 segment that will commence upon identification of the maximum tolerated dose in part~     1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with~     carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment~     arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin~     (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum~     tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W.~     Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).~   "
230912|NCT00534014|"~     Study Goal #1: Determine the optimal oral dose of vitamin C to reduce surrogate markers of~     atherosclerosis (blockages in blood vessels) following the consumption of an atherogenic high~     fat lunch in type 2 diabetic individuals.~      Study Goal #2: After conducting the original study, we found that vitamin E was not effective~     in reducing the markers of oxidative stress, hypercoagulation, inflammation, and metabolic~     parameters in patients with type 2 diabetes.~      To date, data from randomized trials have largely demonstrated no significant benefit of~     vitamin E supplementation on the prevention of primary and/or secondary cardiovascular~     disease as once thought. Therefore, we decided to amend our current protocol to add a Part B~     to study only the effects of vitamin C at the following doses: 500 mg, 1000 mg, and 2000 mg~     daily (and include a placebo arm, as well.~   "
230913|NCT00534001|"~     RATIONALE: Bupropion may help people stop smoking by decreasing the symptoms of nicotine~     withdrawal. Giving bupropion over a longer period of time may be effective in helping people~     stop smoking.~      PURPOSE: This randomized phase II trial is studying how well bupropion works in helping~     adults stop smoking.~   "
230924|NCT00533858|"~     The aim of this study is to evaluate the effect of lacidipine and losartan in elderly~     hypertensive patients on reducing the 24 hour systolic BP variability, which is one of the~     potential parameter to consider in treating elderly hypertensive patients.~   "
230937|NCT00533689|"~     THis study aims to determine whether frequent dosing of intravitreal injections of~     Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a~     deleterious effect on the retina, studied by electrophysiologic testing.~      This prospective, non-randomized clinical study will include patients assigned to~     intravitreal injection of Ranibizumab or Bevacizumab due to neovascular AMD. The patients~     will undergo repeat ophthalmic evaluation and intravitreal injections every 4-6 weeks, as~     long as will be deemed necessary. Periodic electrophysiologic evaluation including~     Electroretinogram (ERG), electro-oculogram (EOG) and Visual Evoked Potentials (VEP) tests~     will be performed every 3 months.~   "
230914|NCT00533988|"~     Intravascular devices are an integral component of modern-day medical practice. Infection is~     one of the leading complications of intravascular catheters and is associated with an~     increased mortality, prolonged hospitalization and increased medical costs. Central venous~     catheters (CVCs) account for an estimated 90% of all catheter-related bloodstream infections~     (CRBSI). A host of risk factors for CVC-related infections have been documented. This~     includes most importantly, duration of catheterization. The duration of use of CVCs remains~     controversial and the length of time such devices can safely be left in situ has not been~     fully and objectively addressed in the critically ill patient. As a consequence, scheduled~     replacement remains widely practiced in many Intensive Care Units(ICUs). Over the past few~     years, antimicrobial impregnated catheters have been introduced in an attempt to limit~     catheter-related infection (CRI) and increase the time that CVCs can safely be left in place.~     Recent meta-analyses concluded that antimicrobial impregnated CVCs appear to be effective in~     reducing CRI. The topic however, remains extremely controversial with different viewpoints~     appearing in the literature recently.~      This was a prospective randomized double-blind study performed in the multidisciplinary ICU~     at Johannesburg Hospital over a four year period.The study entailed a comparison of standard~     triple-lumen versus antimicrobial impregnated CVCs on the rate of CRI. The aim was to~     determine whether the researchers could safely increase the duration of catheter insertion~     time from the standard practice of seven days to 14 days, to assess the influence of the~     antimicrobial impregnated catheter on the incidence of CRI, evaluate risk factors and~     elucidate the epidemiology of CRI.~   "
230915|NCT00533975|"~     The purpose of our study is to evaluate the diagnostic validity of a new immunofecal occult~     blood test (IFOBT) (Teco Diagnostics) in U.S. veterans and to compare it with the guaiac~     based FOBT.~   "
230916|NCT00533962|"~     Introduction: Ocular administration of glucocorticoids is a common and effective treatment~     for several ocular diseases. However it is often complicated with the elevation of~     intraocular pressure (IOP). Anecortave acetate (AA) is an analog of cortisol acetate and~     lacks the typical anti-inflammatory and immunosuppressive properties of glucocorticoids. The~     effect of its anterior juxtascleral depot (AJD) injection has been evaluated in cases of~     glaucoma caused by intravitreal triamcinolone acetonide, presenting impressive results. The~     purpose of this study is to evaluate the efficacy and safety of the AA injection as a~     possible antiglaucoma treatment alternative. Methods: A prospective clinical study will be~     carried out including 30 glaucoma patients (30 eyes). After inclusion each patient will~     receive a single AJD injection of 30 mg of AA in the selected eye. Main outcome measure~     include: intraocular pressure at 1st day, 7th day, 1st, 2nd and 3rd months.~   "
230917|NCT00533949|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as cetuximab can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. It is not yet known whether high-dose radiation~     therapy is more effective than standard-dose radiation therapy when given together with~     combination chemotherapy with or without cetuximab in treating patients with non-small cell~     lung cancer.~      PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation~     therapy given together with chemotherapy with or without cetuximab to see how well they work~     in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be~     removed by surgery.~   "
230918|NCT00533936|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as trastuzumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Giving combination chemotherapy together with trastuzumab~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after~     surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses.~     In this case, observation may be sufficient. It is not yet known whether trastuzumab is more~     effective than observation when given after combination chemotherapy and trastuzumab in~     treating patients with breast cancer.~      PURPOSE: This randomized phase II trial is studying trastuzumab to see how well it works~     compared with observation when given after combination chemotherapy and trastuzumab in~     treating patients undergoing surgery for stage II or stage III breast cancer.~   "
230919|NCT00533923|"~     Allogeneic stem cell transplantation may provide long-term remissions for some patients with~     hematological malignancies. However, allogeneic transplantation is associated with a~     significant risk of potentially life threatening complications due to the effects of~     chemotherapy and radiation on the body and the risks of serious infection. In addition,~     patients may develop a condition called Graft versus host disease that arises from an~     inflammatory reaction of the donor cells against the recipient's normal tissues. The risk of~     graft versus host disease is somewhat increased in patients who are receiving a transplant~     from an unrelated donor.~      One approach to reduce the toxicity of allogeneic transplantation is a strategy call~     nonmyeloablative or mini transplants. In this approach, patients receive a lower dose of~     chemotherapy in an effort to limit treatment related side effects. Patients undergoing this~     kind of transplant remain at risk for graft versus host disease particularly if they receive~     a transplant from an unrelated donor. The purpose of this research study is to examine the~     ability of a drug called CAMPATH-1H to reduce the risk of graft versus host disease and make~     transplantation safer. CAMPATH-1H binds to and eliminates cells in the system such as T cells~     that can cause graft versus host disease (GvHD). As a result, earlier studies have shown that~     patients who receive CAMPATH-1H with an allogeneic transplant have a lower risk of GvHD. In~     the present study, we will examine the impact of treatment with CAMPATH-1H as part of an~     allogeneic transplant on the development of GvHD and infection. In addition, we will study~     the effects of CAMPATH-1H on the immune system by testing blood samples in the laboratory.~   "
230920|NCT00533910|"~     The purpose of this study is to determine whether alteration of gut flora with rifaximin can~     lead to improvement in driving performance, psychometric test performance, and quality of~     life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized,~     blinded, placebo-controlled trial.~   "
230925|NCT00533845|"~     After Laparoscopic surgery most patients experience some form of mild to moderate pain. The~     current standard of care is to treat this pain with local anesthetics (numbing medication,~     that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic~     analgesics (medication injected into your vein to control pain such as morphine).~      Although this treatment improves pain symptoms it is not perfect. Firstly, complete pain~     control is rarely achieved and secondly, narcotics (such as morphine) often have many side~     effects including nausea, vomiting, sedation (sleepiness), constipation and abdominal upset.~     All of these issues make recovery less comfortable and delays return to full function (work,~     school and other activities of daily life).~      A new FDA approved device is now available that offers the benefits of long term anesthesia~     without the side effects of narcotics. It consists of a pump that continuously infuses local~     anesthesia into and around the surgical site. This pump is placed during your operation. You~     then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing~     medicine around your wounds for 2 days continuously.~      The purpose of this study is to see if this pump improves postoperative pain, decreases the~     need for narcotic pain medicine and allows people to return to their activities earlier.~   "
230926|NCT00533832|"~     To confirm the safety and efficacy of the NCP System in treating patients in a nmajor~     depressive episode.~   "
230927|NCT00533819|"~     Healthy physical activity decreases blood pressure in young female school children. It also~     has effects on BMI and maths scores.~   "
230928|NCT00533806|"~     This study will compare the effectiveness of family-based cognitive behavioral therapy to~     family-based relaxation therapy in treating young children with obsessive-compulsive~     disorder.~   "
230929|NCT00533793|"~     A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group,~     international multi-center study. The study will consist of four treatment groups - one~     control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or~     1.0 mg/mL I-040202.~   "
230930|NCT00533780|"~     To learn what effect, if any, Healing Touch (a gentle, non-invasive form of energy work that~     promotes relaxation and can help manage the side effects of chemotherapy and radiation), has~     on physical symptoms, mood, and qualify of life for women undergoing treatment for breast~     cancer.~   "
230931|NCT00533767|"~     This study is designed to evaluate the transmission of hantavirus in Chile. It is an~     observational study that will look at close household contacts of people who have been~     diagnosed with hantavirus infections that result in a serious illness to see how frequently~     they become infected. Subjects who enroll in the study will donate samples of body fluids~     (e.g., blood, saliva, stool, urine, respiratory and vaginal secretions) to allow the~     researchers to see if hantavirus is present in those fluids and if so, how much. Subjects~     will also be interviewed to identify household conditions that may be associated with~     transmission. Up to 76 index cases (people who are first diagnosed with hantavirus~     cadiopulmonary illness) and up to 140 of their close contacts will be enrolled. Subjects will~     be followed for about 6 weeks.~   "
230932|NCT00533754|"~     The aim of the study is to show a higher expression of the Y402H polymorphism in the~     complement factor H in patients with AMD compared to healthy individuals.~      Additionaly a correlation between a subsided infection with chlamydia and patients with AMD~     and a factor H polymorphism will be investigated. An interrelationship with the VEGF-plasma~     level shall give more hints into the pathomechanism of AMD.~   "
230933|NCT00533741|"~     Severe acute respiratory syndrome (SARS) is a viral illness that affects the respiratory~     (breathing) system. The purpose of this study is to evaluate the safety and protective~     (immune) responses to different doses of a SARS vaccine given with or without an adjuvant. An~     adjuvant is a substance that may be added to a vaccine to improve the immune response so that~     less of the vaccine may need to be given. Study participants will include 72 volunteers, ages~     18-40, living in the Houston, Texas area. The study will take place at Baylor College of~     Medicine. Participants will receive 2 injections of vaccine or placebo (substance made to~     look like the study vaccine but contains no medication) given 1 month apart. Participants~     will fill out a memory aid (diary) to document daily temperature and illness signs and~     symptoms for 7-9 days after each injection. During the 9 study visits, several blood samples~     will be collected. Participants will be in the study for up to 211 days, including screening.~   "
230934|NCT00533728|"~     The purpose of this study is to assess the safety of soluble beta-glucan (SBG) in combination~     with antibody and chemotherapy treatment in patients with non-Hodgkin-s lymphoma.~   "
230935|NCT00533715|"~     Spirometry testing should include both expiratory and inspiratory measurements as it may~     influence the expiratory flow volume curve indices. The ability to inhale medication may by~     judged by inspiratory flows. However, the inspiratory portion of the forced flow/volume~     maneuver in young healthy children has not yet been described.Objectives: To document and~     analyze the forced inspiratory flow volume curve indices in healthy young children.~      Settings: Community kindergartens around Israel. participants; Healthy preschool children~     (age 2.5-6.5 years).~      Methods: The teaching method included multi-target, interactive spirometry games (SpiroGame®)~     and accessory games for inspiration (e.g. inspiratory whistle).~      Results: One hundred and fourteen of 157 children performed duplicate full adequate~     inspiratory maneuvers. Repeatability between two maneuvers was 5.6%, 4.0%, 5.1%, 7.3% for~     inspiratory capacity (IVC), forced inspiratory capacity (FIVC), peak inspiratory capacity~     (PIF), and mid inspiratory flow (MIF50), respectively. Inspiratory flow indices were~     significantly lower than the parallel expiratory flow indices and the time to reach PIF was~     significantly slower than the time to reach peak expiratory flow (meanSD; 22921ms vs. 92~     8ms; p<0.0001). The shape of the inspiratory curve was parabolic and did not change with~     age. Predicted equations that were formed were in agreement with the extrapolated prediction~     equation values of older children.~      We found that the majority of healthy young children can produce reliable inspiratory curves.~     Our results provide a framework for reference equations for inspiratory flow volume curve in~     the young ages. The clinical applications of these equations are yet to be explored.~   "
230936|NCT00533702|"~     The primary objective of this study is to determine the progression-free survival (PFS) of~     participants with previously untreated metastatic malignant melanoma when treated with~     IMC-1121B (ramucirumab) alone or in combination with dacarbazine.~   "
230938|NCT00533676|"~     To determine the most effective daily dose of MK0524A when compared with placebo after the~     8-week treatment period for Niacin Induce Flushing (NIF).~   "
230939|NCT00533663|"~     To study the effectiveness of Healing Touch provided during chemotherapy infusions on the~     experience of women undergoing treatment for breast cancer. Healing Touch (HT) is a gentle,~     non-invasive form of energy-balancing work that promotes relaxation and can help manage the~     side effects of chemotherapy.~   "
230940|NCT00533650|"~     A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.~   "
230941|NCT00533637|"~     Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance~   "
230942|NCT00533624|"~     The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150~     sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first~     and second living or deceased donor renal transplant recipients.~   "
230943|NCT00533611|"~     The primary objective of the study is to assess the effects of MK0524A in reducing flushing~     associated with niacin.~   "
230944|NCT00533598|"~     The purpose of this study is to assess the effects of MK0557 on body weight in obese~     subjects.~   "
230945|NCT00533585|"~     The goal of this study is to find the highest tolerable dose of BAY 43-9006 (sorafenib) and~     bevacizumab that can be given with paclitaxel and carboplatin in patients with non-small cell~     lung cancer (NSCLC). The safety and effectiveness of this drug combination will also be~     studied.~   "
230946|NCT00533572|"~     Recessive Dystrophic Epidermolysis Bullosa (RDEB) is a severe inherited blistering skin~     disease caused by absence of type VII collagen. Patients with RDEB develop large, severly~     painful blisters and open wounds from minor trauma to their skin. In the future, we hope to~     start a gene transfer study on a specific group of RDEB subjects and we are screening~     subjects for that potential trial now.~   "
230947|NCT00533559|"~     An increase of plasma free fatty acids impairs insulin secretion and insulin sensitivity,~     thereby playing an important role in causing type 2 diabetes. Lipotoxicity plays an important~     role in the progression from normal glucose tolerance to fasting hyperglycemia and coversion~     to frank type 2 diabetes. A recent publication in the journal Science showed that buphenyl,~     when given to obese diabetic mice, resulted in normalization of hyperglycemia, restoration of~     systemic insulin sensitivity, resolution of fatty liver disease and inhancement of insulin~     action in liver, muscle and adipose tissue. the mechanism of action is believed to be due to~     reduction of endoplasmic reticulum (ER) stress. Buphenyl is currently approved for the~     treatment of rare inherited disorders of the urea cycle. We plan to administer Buphenyl~     orally to humans at a dose far lower than that used for the treatment of urea cycle disorders~     for 2 weeks prior to the testing of pancreatic function. One potential mechanism whereby~     chromically elevated plasma FFAs and glucose impairment beta cell function and insuln~     sensitivity is by ER stress and this can be prevented by administeration of buphenyl.~   "
230948|NCT00533546|"~     The purpose of this research study is to determine the safety and learn more about the dose~     of Activated Protein C (APC) in reducing the damage from stroke.~   "
230949|NCT00533533|"~     Gastric cancer is the most common malignancy in Korea. The prognosis of unresectable gastric~     cancer has been improved by cytotoxic chemotherapy, but median survival rarely exceeds 1~     year. New agents such as taxane, irinotecan and oxaliplatin combined with old agents such as~     5-FU with or without leucovorin, doxorubicin, cisplatin showed higher response rates in phase~     II studies. Docetaxel as a single agents showed response rates of 17-24%, and the combination~     of docetaxel and cisplatin has shown a response rate of 37-56% and overall survival of 9-10.4~     months. Oxaliplatin in combination with 5-FU and leucovorin(FOLFOX-6) showed an objective~     response rate of 50%, which included a 4% complete response. The preclinical studies,~     oxaliplatin has shown additive or synergistic cytotoxic properties with fluoropyrimidines,~     thymidylate synthase inhibitors, topoisomerase I inhibitors, microtubule inhibitors and DNA~     modifying/alkylating agents. The combination of docetaxel and oxaliplatin has been studied~     previously in the phase I setting in patients with metastatic breast and non-small cell lung~     cancer. The combination of docetaxel and oxaliplatin is a feasible and well tolerated~     regimen. Recommended doses were 75mg/m2 for docetaxel on day 1 and 70mg/m2 for oxaliplatin on~     day 2 without G-CSF support. The aim of this trial is to determine the dose limiting~     toxicities, maximum tolerated dose(MTD) and efficacy of oxaliplatin and docetaxel as~     combination chemotherapy in patients with advanced gastric cancer.~   "
230950|NCT00533520|"~     Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet~     age-related macular degeneration (AMD).~   "
230951|NCT00533507|"~     The purpose of this study is to assess the immunogenicity in terms of antibody response and~     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse~     events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine~     GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined~     vaccine and rotavirus vaccine in children during the first 6 months of life.~   "
230952|NCT00533494|"~     Despite the advent of efficacious medicines, there is a gap between ideal and actual care in~     the achievement of recommended outcomes among diabetic patients. The study enrolled 429~     diabetic patients attending four HMO clinics in Israel, two in the northern region and two in~     the southern region. All clinics were randomly selected from all clinics affiliated with the~     Faculty of Health Sciences of the Ben Gurion University. The objective of the study was to~     compare the effects of a multi-component physician-patient intervention to physician feedback~     alone on a combined outcome of diabetes, blood pressure and serum lipids control. We~     hypothesized that in medical practices where physicians have received feedback on quality of~     care indicators, patients who received a letter encouraging them to discuss a list of~     important diabetes-related issues with their doctors, would experience better outcomes~     compared to patients who did no received such a letter.~   "
230953|NCT00533481|"~     Study medicine will be given alone, or in combination with either sibutramine or orlistat, to~     obese subjects to compare the effect on body weight over a six month period.~   "
230954|NCT00533468|"~     The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of~     infants undergoing Lumbar Puncture (spinal tap).~   "
230955|NCT00533455|"~     We will attempt to establish whether gabapentin as compared with placebo will reduce the~     severity of tremors caused by the use of antipsychotic medications. Baseline severity of~     tremor will be measured using both clinical ratings and ratings obtained with an instrument~     designed to measure tremor, giving more objective evidence of tremor frequency and severity.~   "
230957|NCT00533429|"~     The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab~     plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival~     time without disease progression in the first-line treatment of patients with advanced stage~     non-small cell lung cancer.~   "
230958|NCT00533416|"~     This study will determine the highest dose of the experimental drug ON 01910.Na that can~     safely be given to patients with the bone marrow disorder myelodysplasia (MDS) and patients~     with refractory AML with trisomy 8. In this disease, the bone marrow can make some blood~     cells, but very few of these cells are released into the blood for use in the body. ON~     01910.Na is an experimental drug that inhibits a protein called cyclinD1that is important for~     keeping MDS cells alive. In laboratory experiments, ON 01910.Na has acted against cyclinD1,~     causing MDS cells to die. The study will also evaluate how the body handles ON 01910.Na, the~     effect of the drug on MDS and AML and its side effects.~      Patients 18 to 85 years old with MDS or AML who do not have a suitable sibling donor for a~     marrow transplant or who are not willing to have a transplant may be eligible for this study.~      Participants receive ON 01910.Na in 2-week treatment cycles, with 3 to 5 days of drug~     infusion through a vein followed by 9 to 11 days of observation. To find the highest safe~     dose of ON 01910.Na, the first person enrolled in the study is given the smallest study dose~     of the drug for 3 days, followed 2 weeks later with a second dose for 3 days. If these doses~     are found safe, the next two people receive the same dose. If these subjects do well, the~     next group of patients receives the next higher dose level. The dose continues to be~     increased in groups of 3 to 6 subjects until the fourth and highest dose level is reached.~     Patients who do well on the treatment may receive an additional six cycles of ON 01910.Na (3~     to 5 days of infusion once every other week for 12 weeks).~      Before, during and after the treatment period, patients are periodically evaluated and~     monitored with the following tests and procedures:~        -  Physical examination and review of medical and medication history.~        -  Blood and urine tests.~        -  Pregnancy test for women of childbearing age.~        -  Electrocardiogram (EKG) and chest X-ray.~        -  Bone marrow biopsy.~   "
230959|NCT00533403|"~     To compare the pain relieving effect of MK0686 to placebo or ibuprofen after dental surgery.~   "
230960|NCT00533390|"~     Rifampicin is a potent inducer of the CYP450 and decrease the plasmatic concentration of~     NNRTI and Protease Inhibitors. In our study we are going to compare the 600 an 800mg doses of~     efavirenz concomitant of rifampicin use to treat tuberculosis. The hypothesis is that the 800~     mg dose would be more adequate than the 600mg~   "
230961|NCT00533377|"~     The purpose of this study is to find out the good and bad effects of an investigational drug~     called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal~     fixation using reamed inter-locked IM nailing procedure~   "
230962|NCT00533364|"~     This study is set up to determine whether soluble beta-glucan (SBG) has~        -  unfavourable side effects~        -  beneficial treatment effects when given in combination with standard antibody and~          chemotherapy to patients with breast cancer.~   "
230963|NCT00533351|"~     This study will explore the safety and efficacy of AGN201781 in patients with postherpetic~     neuralgia or post-traumatic peripheral neuralgia~   "
230964|NCT00533338|"~     The specific aims of this study are:~        1. To test the feasibility of a randomized controlled trial of a weight gain prevention~          program for breast cancer survivors that combines exercise and dietary changes during~          treatment. Feasibility will be evaluated by examining data on recruitment rate,~          attendance at intervention sessions, drop-out rates in both study conditions, assessment~          completion rates, and participant feedback.~        2. To test the effect of a weight gain prevention program, compared to usual care, on~          weight, body composition, and biomarkers related to breast cancer prognosis.~        3. To explore whether changes in physical activity, energy intake, and resting energy~          expenditure predict weight gain among breast cancer survivors.~        4. To test the effect of a weight gain prevention program on quality of life variables.~   "
230965|NCT00533312|"~     A study to determine lipid changing effects of MK0524A when compared to niacin extended~     release (NIASPAN) and placebo.~   "
230966|NCT00533299|"~     The current standard for recurrent, persistent or metastatic cisplatin-resistant ovarian~     cancer is palliative chemotherapy with either topotecan, liposomal doxorubicin or~     gemcitabine, however, the results need to be improved. Epigenetic aberrations play an~     important role in cancer progression by silencing growth regulatory genes and there is now~     evidence that inhibitors of DNA methylation and HDAC inhibition synergize the cytotoxicity of~     chemotherapy.~      Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate~     plus topotecan over placebo plus topotecan upon progression-free survival.~      Hypothesis. Hydralazine and magnesium valproate associated to topotecan will increase~     progression-free survival from 6 to 9 months as compared with the same regimen of~     chemotherapy plus placebo.~   "
230967|NCT00533286|"~     Sixty patients were randomized to receive either placebo or diazepam in addition to~     mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of~     clinically and radiologically confirmed lumbar disk prolapse~   "
230968|NCT00533273|"~     This 12-month study had two phases: a 90-day double-blind, randomized, placebo-controlled~     phase and a nine-month open-label extension phase. Before treatment, eligible subjects were~     stratified by the primary joint type (30 metacarpophalangeal [MP] joints and 30 proximal~     interphalangeal [PIP] joints) and by severity of the primary joint contracture (ie, up to 50°~     or >50° for MP joints and up to 40° or >40° for PIP joints) and then randomized in a 2:1~     ratio to either AA4500 0.58 mg or placebo. Upon completion of the double-blind phase (ie,~     90-day evaluation after the first injection), all subjects were eligible to enter the~     open-label extension phase of the study in which they were followed for an additional nine~     months. Subjects who required further treatment because they either did not achieve reduction~     in contracture to 5° or less, the cord affecting the primary joint received placebo, another~     cord received less than three injections of AA4500, or they had untreated cords that were~     affecting other joints had the option to receive up to five additional injections of AA4500~     0.58 mg in the open-label extension phase, with individual cords receiving up to three~     injections of AA4500.~      This study was designed to be part of the larger clinical program, for adult patients with~     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal~     Placebo-Controlled studies (AUX-CC-857 [NCT00528606] and AUX-CC-859 [NCT00533273]) and 7~     non-pivotal studies were evaluated.~   "
230969|NCT00533260|"~     The basic hypothesis of this trial is that forgetfulness and failure to establish a routine~     that facilitates medication adherence are prominent reasons for non-adherence. Daily use of~     the SMS text messages is designed to enhance patient adherence with medication by promoting~     daily routine and demonstrate the feasibility of using SMS technology within normal clinical~     practice in The Netherlands.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
230970|NCT00533247|"~     This double blinded, placebo controlled, study seeks to determine the efficacy of~     preoperative anti-inflammatory therapy on the reduction of postoperative pain in knee~     arthroplasty surgery. Pre-emptive use of NSAIDS has demonstrated only modest reduction in~     post-operative pain in previous studies. However, the short duration of dosing in those~     studies did not capitalized on the anti-inflammatory properties of NSAIDS. Short-term use of~     NSAIDS only provides pain relief and does not address inflammation. Traditional NSAIDS cannot~     be used preoperatively due to platelet effects. Celecoxib, however, is both an analgesic and~     anti-inflammatory, but does not interfere with bleeding. It can therefore be safely used~     before surgery. This study hypothesizes that the use of celecoxib for seven days~     preoperatively reduces postoperative inflammation and consequently pain. A detailed Medline~     search has not identified any studies into the preoperative use of an NSAID at a dosing level~     that achieves anti-inflammatory effects.If effective in reducing postoperative pain, this~     research could lead to a new understanding of the role inflammation plays in orthopedic~     procedures and other elective procedures and thus improve patient outcomes in the future.~   "
230971|NCT00533234|"~     The purpose of this prospective clinical data collection is to document the performance and~     clinical outcomes of the ExploR® Modular Radial Head. This data collection effort will~     document the clinical outcomes of the radial head.~   "
230972|NCT00533221|"~     The purpose of this study is to determine whether Growth hormon can increase strength in~     spinal muscular atrophy type II and III.~   "
230973|NCT00533208|"~     To assess the efficacy of MK0524 on seasonal allergies.~   "
230974|NCT00533195|"~     The purpose of this study is to compare the efficacy, tolerability and remission duration of~     UVA 1 therapy versus 5-MOP UVA photochemotherapy for patients with severe generalized atopic~     dermatitis.~   "
230975|NCT00533182|"~     This study will evaluate how the immune system responds to influenza infection and compare~     how the infection differs in patients with a weakened immune system versus those with a~     healthy immune system.~      Patients at the NIH Clinical Center who are older than 2 years of age and who are diagnosed~     with influenza A or B may be eligible for this study. Patients with healthy immune systems~     and weakened immune systems are included.~      Participants answer questions about how they are feeling and have a physical examination to~     evaluate their symptoms. Blood and nasal fluid are collected on the first day and then every~     other day for a total of 8 days. Nasal fluid is collected by either inserting a small tube in~     the nose and washing the nose with salt water and collecting the fluid obtained, or by~     rubbing the inside of the nose with a swab. Physical examinations are repeated on the days~     that blood and nasal fluid are collected.~   "
230976|NCT00533169|"~     The goal of this clinical research study is to find the highest safe dose of the drug~     ZactimaTM (ZD6474) in patients with neuroblastoma or medulloblastoma that has gotten worse,~     has come back, or has not responded to the treatment.~      Primary Objective:~      -To determine the pharmacokinetics, safety, dose-limiting toxicities, and maximum tolerated~     dose of ZD6474, alone in children with medulloblastoma, and alone in combination with~     retinoic acid, in patients with relapsed or refractory neuroblastoma.~      Secondary Objective:~      -To assess progression-free survival (PFS) and objective tumor response rates in children~     with relapsed and refractory neuroblastoma and medulloblastoma treated with ZD6474 +/-~     retinoic acid in the context of a Phase I trial.~   "
230977|NCT00533156|"~     The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical~     Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or~     interventional coronary procedures using a standard 7F introducer sheath.~   "
230978|NCT00533143|"~     The occurrence of acute respiratory failure (ARF) is often seen by oncologists as a terminal~     phase of the disease, this view being based on studies reporting limited survival at~     considerable costs in such patients. A large proportion of cancer patients with severe~     respiratory failure are denied admission to an ICU because intensive care specialists are~     aware that intubation and mechanical ventilation are both strong predictors of mortality in~     critically ill cancer patients. This holds particularly true in the subset of patients who~     are not receiving chemotherapy or radiotherapy because of the advanced stage of their~     disease, and who are also not affected by an episode of ARF, related to a reversible cause.~      These patients often receive oxygen therapy and morphine in an attempt to improve oxygenation~     and/or relieve the ensuing dyspnea.~      Non-invasive mechanical ventilation (NIV) is now the first line treatment of ARF in selected~     populations (e.g., those with COPD) and has been used sporadically as a potential treatment~     of acute respiratory failure in patients with a do-not-intubate order. The International~     Consensus Conference on Intensive Care Medicine stated that the use of NIV may be justified~     in selected patients who are not to be intubated and may provide patient comfort and~     facilitate physician-patient interaction. Early NIV has been successfully used so far in~     cancer patients only to prevent intubation among those with hematologic malignancies, while a~     pilot study has assessed the feasibility of NIV also as a palliative treatment of end-stage~     solid cancer patients. So far we are lacking data about the pure palliative effects of~     NIV,in patients with end-stage solid cancer.~      The aim of this multicenter randomised study will be to evaluate on a large scale the~     feasibility, clinical efficacy and impact on quality of life and dyspnea of NIV versus~     standard medical in patients with respiratory failure, not related to a reversible cause, and~     solid cancer needing palliative care treatment.~   "
230979|NCT00533130|"~     1. Is the AO Pediatric classification for long bones fractures reproductible?~        2. Is the AO Pediatric Classification for long bones fractures a treatment guide?~        3. The AO pediatric Classification for long bones fractures could be a prognosis factor?~   "
230980|NCT00533117|"~     This study will determine whether dialectical behavior therapy and fluoxetine are more~     effective combined or alone in treating people with borderline personality disorder.~   "
230981|NCT00533104|"~     The primary focus of the trial is safety and efficacy of the intra-muscular implantation of~     either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as~     judged by the proportion of patients which are alive without major amputation 6 months after~     inclusion.~   "
230982|NCT00533091|"~     The primary objective of the study is to evaluate the safety and tolerability of multiple IV~     doses of MEDI-545 in adult patients with myositis.~   "
230983|NCT00533078|"~     In patients with acute myelogenous leukemia (AML), a high proportion will suffer from~     inflammation of the large bowel (colitis) during their intensive treatment. As there is no~     standard treatment available for this potentially lifethreatening condition, the~     investigators focus on the role of parenteral nutrition which these patients inevitably~     require. Preclinical and clinical data have shown strong anti-inflammatory properties of fish~     oil preparations containing poly-unsaturated omega3 fatty acids (PUFA) as opposed to other~     lipid fractions. There may be a therapeutic benefit of adding omega3 PUFA to standard~     nutrition in patients with chemotherapy-induced colitis. In this small phase II study, the~     investigators address the effectiveness of this approach to reduce the incidence and severity~     of colitis in AML patients.~   "
230984|NCT00533065|"~     The planned study has two purposes:~        1. It is to provide evidence that the administration of a cholinesterase inhibitor will~          result in an increase of IGF-I (primary variable) and in an increase of the secretion~          growth hormone (secondary variable) that can be maintained throughout the~          treatment-period of one year.~        2. The study also tests the hypothesis that maintenance of increased blood levels of growth~          hormone and IGF-I can stop or delay the age-related changes of body composition~          (secondary variables) .~   "
230985|NCT00533052|"~     Behavioral weight loss, the current treatment of choice for moderate obesity, achieves~     impressive short term results, however, weight regain following treatment is a major problem.~     Over 50% of participants in behavioral weight loss programs report difficulty with internal~     antecedents to unhealthy weight control behaviors and this difficulty is associated with~     weight regain following treatment. Current treatment approaches do not adequately address~     these antecedents. The aim of this series of studies is to develop, implement, and evaluate a~     behavioral weight loss program modified to provide participants with skills to deal~     effectively with affective and cognitive difficulties. The study targets men and women with~     BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to~     unhealthy weight control behaviors. The study is an uncontrolled pilot study in 20~     participants to initially assess acceptability and efficacy of the innovative treatment. The~     long-term goal of this research is to improve the weight loss maintenance outcomes of~     behavioral weight loss programs by addressing affective and cognitive antecedents to~     unhealthy weight control behaviors.~   "
230986|NCT00533039|"~     As evidence accumulates that atherogenesis or Coronary Artery Disease (CAD) may not be simply~     a disorder of lipid metabolism, but an inflammatory disease, the focus of treatment has~     shifted. A-002 or Varespladib is an anti-inflammatory drug for treatment of chronic and acute~     diseases. It acts by inhibiting secretory phospholipase A2 (sPLA2 ) - one of a family of~     enzymes leading to inflammation - which may be important in: 1) the development of~     atherosclerosis and 2) the increase in occurence of cardiovascular events after angioplasty.~     Previous studies have demonstrated that sPLA2: 1) facilitates the pro-atherogenic effects of~     low-density (LDL or bad cholesterol) and 2) increased levels post-angioplasty correlate with~     an increased risk of events at followup contact. Therefore this study proposes to investigate~     the ability of A-002 to prevent or reduce myocardial damage after angioplasty by inhibiting~     the cascade of inflammatory mediators.~      Substudy - Subjects who agree will also have a vascular ultrasound 24h post-PCI to assess~     endothelial function.~   "
230987|NCT00533026|"~     To evaluate the blood clotting effects of multiple doses of warfarin at steady state when~     taken at the same time as multiple doses of duloxetine as measured by changes in the~     International Normalised Ratio. All subjects will begin dosing with warfarin, then after~     approximately 12 days, duloxetine 60 mg is added and subjects with stabilized INR will either~     continue dosing at 60 mg or have a dose increase to 120 mg.~   "
230988|NCT00533013|"~     The purpose of this study is to determine whether a nurse-led, comprehensive disease~     management program is effective in reducing recurrent hospital admissions and deaths in~     community dwelling patients with moderate to severe heart failure.~   "
230989|NCT00533000|"~     The primary aim of this study is to evaluate the effect of preoperative smoking cessation on~     postoperative complications among patients undergoing surgery. Secondary aims are to evaluate~     effect on wound complications, short and long term effects including abstinence rate, pain,~     quality of life and effects on the immune system.~   "
230990|NCT00532987|"~     Treatment of rectal cancer often consists of surgical resection of the tumor. Chemotherapy~     and/or radiotherapy are frequently given before or after surgery. In this study, we wish to~     learn if there are differences in the treatment effectiveness or in the quality of life of~     patients based on their type of treatment (e.g. Radiotherapy and chemotherapy before or after~     surgery). Information from this questionnaire collected from you and other patients may help~     improve the quality of life of rectal cancer patients in the future. Medical information on~     your tumor, treatment received, and side effects will be compiled and maintained in a~     database to learn more about outcomes of treatment for rectal cancer.~   "
230991|NCT00532974|"~     The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization~     schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL~     epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination~     antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.~   "
230992|NCT00532961|"~     Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular~     tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of~     TobraDex in healthy volunteers, when either product was administered QID (at approximately~     4-hour intervals) for 28 days.~   "
230993|NCT00532948|"~     This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities,~     of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed~     diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered~     twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of~     radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard~     dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week~     break. The anticipated time on study treatment is 3-12 months, and the target sample size~     will not exceed 30 evaluable patients.~   "
230994|NCT00532935|"~     A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used~     medication in patients with type 2 diabetes~   "
230995|NCT00532922|"~     The purpose of this study is to investigate real practices of treatment with Symbicort~     Turbuhaler for 3 months in asthma and patient compliance.~   "
230996|NCT00532909|"~     To determine the maximum tolerated dose of Vandetanib with a current standard first-line~     chemotherapy regimen, capecitabine and oxaliplatin without and then with bevacizumab for the~     first line treatment of metastatic colorectal cancer (CRC) and to define the dose limiting~     toxicities associated with the combination.~   "
231151|NCT00530842|"~     The primary objective of this study is to demonstrate that treatment with a free combination~     of tiotropium and salmeterol provides superior improvement in static lung volumes and~     exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients~     with COPD.~      The secondary objective includes assessment of safety.~   "
230997|NCT00532896|"~     Increase in body mass index (BMI)is associated with a decrease in expiratory flows.Obesity is~     also associated with an increased prevalence of asthma.Consequences of obesity on respiratory~     function and on bronchial responsiveness are still to be documented.~      This study aims to evaluate, before and after surgery, the impact of a bariatric surgery~     (biliopancreatic diversion with duodenal switch)on respiratory function in patients with~     morbid obesity .~      Our hypothesis is that weight loss following bariatric surgery will induce significant~     improvements in pulmonary function and airway responsiveness, and, as a consequence, a~     reduction in respiratory symptoms,these changes being correlated with a reduction in systemic~     markers of inflammation. Maintenance of weight loss after one year will permit the~     persistence of these improvements~   "
230998|NCT00532883|"~     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease~     that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is~     characterized by dense red blood cells. The purpose of this study is to evaluate the safety~     and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red~     blood cell density and the frequency of pain episodes in people with HbSC.~   "
230999|NCT00532870|"~     The laparoscopic repair of ventral hernias is still a controversial therapeutic option. To~     evaluate the efficacy and safety of laparoscopic repair we compare the results of the open~     and laparoscopic repair of ventral hernia,. 53 patients were undergo laparoscopic or open~     repair of ventral hernia . All defects were estimated to be larger than 5 cm in diameter.~     Twenty six patients underwent attempted laparoscopic ventral hernia repair (LVHR) with mesh~     and twenty seven patients underwent open ventral hernia repair (OVHR) with mesh~   "
231000|NCT00532857|"~     To evaluate the pathologic complete response rate to preoperative administration of~     Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)~   "
231001|NCT00532844|"~     This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover,~     pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with~     endothelial dysfunction following 14 days of treatment by each of 2 regimens: 6R-BH4 with~     vitamin C and 6R-BH4 alone.~   "
231002|NCT00532831|"~     Our hypothesis:~      Obese subjects with a physician's made diagnosis of asthma have a poorer asthma control than~     asthmatics with normal weight, less variability of peak expiratory flows (PEF) and~     bronchodilator response,increased induced sputum and systemic markers of inflammation and an~     increased prevalence of atopy.~      Obese subjects have an increased incidence of co-morbidities such as rhinosinusitis,~     gastroesophageal reflux and sleep apnea syndrome.~      This study aims to determine if, in comparison with asthmatics with a normal weight, paired~     for age and sex, obese subjects with asthma (all not using anti-inflammatory agents) show:~        -  A more uncontrolled asthma, increased health care use and poorer quality of life~        -  A reduced response to bronchodilators and diurnal variability of expiratory flows~        -  More marked airway inflammation and evidences of a systemic inflammatory response~        -  An increased prevalence of co-morbidities which can influence the report of respiratory~          symptoms or the severity of the disease, such as esophageal reflux symptoms, upper~          airway disease (rhinitis) and sleep apnea syndrome or other sleep disorder.~   "
231003|NCT00532818|"~     The current standard for recurrent, persistent or metastatic cervical cancer is palliative~     chemotherapy with cisplatin topotecan, however, the results need to be improved. Epigenetic~     aberrations play an important role in cancer progression by silencing growth regulatory genes~     and there is now evidence that inhibitors of DNA methylation and HDAC inhibition synergize~     the cytotoxicity of chemotherapy.~      Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate~     plus standard cisplatin topotecan against placebo plus cisplatin topotecan upon~     progression-free survival.~      Hypothesis. Hydralazine and magnesium valproate associated to cisplatin topotecan will~     increase progression-free survival from 4.6 to 7.6 months as compared with the same regimen~     of chemotherapy plus placebo.~   "
231004|NCT00532805|"~     Individuals with a deficiency of alpha-1 antitrypsin (AAT) often develop emphysema.~     Traditional lung function tests may not be the most accurate way to measure the progression~     of emphysema. This study will compare high resolution computed tomography (CT) scans to~     spirometry to measure the progression of emphysema.~   "
231005|NCT00532792|"~     This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum~     of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this~     study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low,~     medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will~     be performed in two parts.~      In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A~     Safety Review Committee (SRC)will review all safety data, including laboratory values,~     through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments~     are considered safe, Part 2 of the study will be initiated and a second vaccination will be~     administered to subjects in Part 1 on Day 21.~      In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same~     visit structure and protocol-defined requirements as subjects in Part 1, without the~     additional laboratory safety measurements. An SRC review will also be performed of all safety~     data through the Day 28 visit for subjects participating in Part 1.~   "
231006|NCT00532779|"~     The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR~     and bupropion SR are safe and effective in the treatment of obesity.~   "
231007|NCT00532766|"~     To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)~     after subcutaneous administration, and to compare this profile with Humulin insulin.~   "
231008|NCT00532753|"~     The Hunger Project/Epicenter strategy is a community based development strategy that will~     positively affect health, education, empowerment, and consumption.~   "
231009|NCT00532740|"~     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near~     a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be~     effective treatment for liver cancer that cannot be removed by surgery.~      PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating~     patients with metastatic liver cancer that cannot be removed by surgery.~   "
231010|NCT00532727|"~     The purpose of this study is to determine whether there is greater activity for carboplatin~     than a taxane standard of care (docetaxel) in women with ER-, PR- and HER2- breast cancer.~     The trial aims to recruit between 370 and 450 patients.~   "
231012|NCT00532701|"~     Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400~     mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in~     patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study~     has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who~     received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or~     standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for~     these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high~     response rates, several studies have shown that when these patients had rapid virologic~     response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA)~     levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment~     could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin~     for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in~     these patients who achieved RVR. While studies showed concordant results in SVR rates for~     patients with genotype 3 CHC who received peginterferon plus low dose or weight-based~     ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in~     patients with genotype 2 CHC who received such treatment. Currently, there are no studies on~     the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of~     treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to~     conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of~     peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.~   "
231013|NCT00532688|"~     Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure~     leads to improvements in vascular function and in renal function.~   "
231014|NCT00532675|"~     This study will evaluate the safety of LBH589 given in combination with lenalidomide and~     dexamethasone in adult patients with multiple myeloma~   "
231015|NCT00532662|"~     Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central~     sensitization during surgery and result in preemptive analgesia. The purpose of this study is~     to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have~     shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.~   "
231016|NCT00532636|"~     Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and~     maintaining an upper airway patent. Designing a ventilating device that could indicate how to~     open an upper airway correctly may be beneficial. The head of children is randomly placed in~     different head positions by one investigator. A ventilating mask is then pressed gently on~     the child's face followed by measurement of the head position angles and pulmonary function.~     This information could be utilised to optimise assisted ventilation of an unprotected upper~     airway in children.~   "
231017|NCT00532623|"~     To evaluate the overall response rate of gemcitabine and vinorelbine combination (GV) and~     gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with~     stage IV and recurrent breast cancer.~   "
231018|NCT00532610|"~     This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3~     days at a normal dose and a higher than normal dose compared to placebo or to a single dose~     of moxifloxacin. Treatments are GSK189075 500mg daily for three days plus moxifloxacin~     placebo on Day 3; GSK189075 4000mg daily for three days plus moxifloxacin placebo on Day 3;~     placebo tablets daily for three days plus moxifloxacin placebo on Day 3; placebo tablets~     daily for three days plus Moxifloxacin 400mg on Day 3. Volunteers are blindfolded during~     dosing. Each volunteer participates in all four treatment periods and will have received each~     dose combination at study end. Volunteers will stay at the research unit from the day before~     the first dose of study drug until the day after the last dose of study drug of each period.~     Safety measures include vital signs, laboratory tests on blood and urine, physical exams and~     ECGs. Volunteers wear a Holter monitor (a device that records heart rate and rhythm~     continuously) on days 1 and 3. Study drug levels are assessed by multiple blood draws, most~     of which occur on day 3.~   "
231019|NCT00532597|"~     The purpose of this study is to determine whether on-line hemodiafiltration ameliorate the~     endothelial dysfunction compared with the low flux hemodialysis in end stage renal disease~     patients on maintenance hemodialysis.~   "
231020|NCT00532584|"~     Cigarette smoking is the main risk factor for chronic obstructive pulmonary disease (COPD).~     The cells lining the lung airways (epithelium) and the cells on the surface of the epithelium~     (alveolar macrophages) of healthy smokers develop characteristic gene expression changes that~     are different from that of nonsmokers. These gene expression changes include up- and~     down-regulation of genes in functional categories known to be relevant to the development of~     COPD. Administration of anti-inflammatory medications (inhaled steroids) in combination with~     long acting medications that open the airways (bronchodilators), are known to decrease the~     rate of acute exacerbations and improve the quality of life of individuals with COPD;~     however, the mechanisms underlying these beneficial effects of are poorly understood. This~     study will assess the effect of traditional therapy for COPD (inhaled corticosteroids, an~     anti-inflammatory medication, plus a bronchodilator, a medication that helps open the~     airways) on smoking-induced gene changes in airway epithelium and alveolar macrophages.~     Volunteer subjects will be evaluated by bronchoscopy to sample lung cells at 0, 7 and 14~     days, with the therapy given at day 1 through day 7. The bronchoscopy aspects of this study~     will be covered by approved Weill-Cornell IRB protocol # 0005004439 (see below.)~      To participate in this protocol, the research subject will first be enrolled in Weill-IRB~     protocol #0005004439 entitled Evaluation of the Lungs of Normal (Smokers, Ex-smokers,~     Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and~     Bronchial Wall Biopsy, fulfilling the inclusion/exclusion criteria of that protocol. They~     will be invited to participate in this protocol only if they meet the additional~     inclusion/exclusion criteria of this protocol.~   "
231021|NCT00532571|"~     To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients~     with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive~     supranuclear palsy (PSP) ).~   "
231022|NCT00532558|"~     The purpose of the study is to determine the reduction of LDL-cholesterol level after~     treatment with 50 mg per day of lapaquistat acetate once daily (QD).~   "
231023|NCT00532545|"~     To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously,~     for one month, are able to produce reliable changes in the bone marker in a severe~     osteoporotic population~   "
231024|NCT00532532|"~     A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity~     associated with multiple sclerosis. This study has three purposes:~        1. To determine whether AV650 is safe for patients with multiple sclerosis;~        2. To gather some early evidence as to whether AV650 is effective in treating spasticity in~          patients with multiple sclerosis; and,~        3. To assess what the body does with AV650 once it is ingested (Germany and Czech Republic~          sites only).~   "
231025|NCT00532519|"~     Prurigo nodularis (PN) is a common dermatological disorder, manifested as scaly nodules which~     appear mainly on the extensor surfaces of the limbs. PN may appear secondarily to skin~     scratching in chronic hepatitis, liver cirrhosis, uremia, hypothyroidism etc. Nevertheless,~     in many cases no underlying physical disease is present. According to the literature, in~     fifty percent of the patients there is co-morbidity with depression, anxiety or somatoform~     disorders.~      We hypothesize that a group of these patients may benefit from antidepressant therapy.~   "
231026|NCT00532506|"~     The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in~     patients with Type2 Diabetes Mellitus~   "
231027|NCT00532493|"~     Background: Posttraumatic stress disorder (PTSD) is a debilitating and disabling mental~     disorder that afflicts at least 25% of Veterans who have suffered life-threatening war zone~     trauma. Trauma-related nightmares and sleep disturbance are among the most~     treatment-resistant PTSD symptoms in Veterans. Increased responsiveness to central nervous~     system (CNS) norepinephrine (NE) contributes to the pathophysiology of overall PTSD and~     treatment-resistant nighttime symptoms. Placebo-controlled pilot studies demonstrate that the~     generically available CNS-active alpha-1 adrenoreceptor antagonist prazosin substantially~     reduces PTSD trauma nightmares and sleep disturbance and improves global clinical status~     (sense of well being and ability to function) in Veterans.~      Objective: The primary objective is to demonstrate in a large multi-site placebo-controlled~     trial in Veterans with war zone trauma-induced PTSD that prazosin is efficacious for PTSD~     trauma nightmares, sleep disturbance, and global clinical status. A secondary objective is to~     demonstrate prazosin effectiveness for these outcome measures during clinically meaningful~     long-term (26 week) maintenance treatment of PTSD. The investigators will also address~     prazosin efficacy and long-term effectiveness for improving total PTSD symptoms, comorbid~     depression, quality of life, and physical functioning.~      Methods: This 26 week randomized double-blind placebo-controlled study is designed to~     demonstrate both short term efficacy and long term effectiveness of prazosin for PTSD. The~     research design encompasses a shorter-term, more tightly controlled efficacy component and a~     longer-term, more .real world. effectiveness component. Three hundred twenty-six Veterans~     with war zone -related PTSD and persistent trauma nightmares will be randomized 1:1 to~     prazosin or placebo. Study drug will be increased using a flexible dose titration schedule~     based on clinical response and adverse effects to an optimum maintenance dose (1-20 mg/day).~     During the first 10 weeks of the study, participants will be randomized to prazosin or~     placebo. Previous psychotropic medications and/or psychotherapy will be maintained constant.~     Short term efficacy will be determined during the first 10 weeks. During the remaining 16~     weeks of the 26 week trial, subjects will continue to receive stable-dose double-blind~     prazosin or placebo, but will have the option to receive additional psychotropic medications~     and/or psychotherapeutic interventions, as needed, per the judgment of the study Clinician~     Prescriber. It is hypothesized that prazosin will remain more clinically effective than~     placebo at the end of the 26-week trial, demonstrating that prazosin adds benefit~     over-and-above other treatments that are naturalistically administered by providers in a~     .real world. clinical setting.~      Prazosin will be judged efficacious at 10 weeks if superior to placebo on all three primary~     outcome measures assessing trauma nightmares, sleep disturbance, and global clinical status:~     the Recurrent Distressing Dreams item of the Clinician Administered PTSD Scale (CAPS), the~     Pittsburgh Sleep Quality Index (PSQI), and the Clinical Global Impression of Change (CGIC).~     Secondary outcome measures will assess prazosin effects on total PTSD symptoms, depression,~     physical functioning, and quality of life. Adverse effects and cardiovascular measures,~     including supine and standing blood pressure (BP) and heart rate (HR) will be assessed.~   "
231028|NCT00532480|"~     The purpose of this study is to find out what parts of the brain have increased or decreased~     activity when people are depressed and how antidepressant medicine changes this activity in~     depressed patients. The genetic samples collected are to look at variation in a gene~     (serotonin transporter gene), which affects the functioning of the chemical serotonin in the~     brain~   "
231029|NCT00532467|"~     This study is the second study to evaluate SRX251 in healthy volunteers and it represents the~     first multiple dose study. The primary objective of this study is to evaluate the safety and~     tolerability of escalating multiple oral doses of SRX251 capsules for 5 days in healthy adult~     volunteers. Levels of the drug in blood plasma will also be determined.~   "
231030|NCT00532454|"~     Primary objectives of this study is to evaluate the effects of CYP2D6 genotypes on time to~     progression after tamoxifen treatment in pre- or postmenopausal women with metastatic breast~     cancer. Furthermore, we will evaluate the effects of CYP2D6 genotypes on clinical benefit and~     response duration to tamoxifen administration in pre- or postmenopausal women with metastatic~     breast cancer and also evaluate the effects of CYP2D6 genotypes on the steady state plasma~     concentration of tamoxifen and its metabolites~   "
231031|NCT00532441|"~     An unmet medical need exists for the successful therapy of patients with advanced~     hepatocellular and biliary tract malignances, with few and short lived disease responses to~     chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows~     cooperative antitumor activity between an epidermal growth factor receptor (EGFR) tyrosine~     kinase inhibitor and taxanes. The efficacy of erlotinib in combination with docetaxel will be~     assessed in this trial.~   "
231032|NCT00532428|"~     This is a cross-sectional study to determine, via iliac crest bone biopsies, the effect of~     long-term treatment with raloxifene on histomorphometry and bone quality in patients who~     participated in the Continuing Outcomes Relevant to Evista Study.~   "
231033|NCT00532415|"~     The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide~     suspension when used for visualization of structures in the back of the eye during eye~     surgery.~   "
231034|NCT00532402|"~     This study should compare the propofol concentration in breathing gas and in plasma (before~     and) after lung passage. Propofol concentrations in breathing gas are continuously measured~     by a sensor. For comparison a discontinuous method is used. Neurophysiologic parameters for~     determination of depth of anesthesia are compared to the continuous measured propofol~     concentration in breathing gas.~      Study hypothesis: continuous measured propofol concentration in breathing gas correlates to~     propofol concentration in plasma and depth of anaesthesia.~   "
231035|NCT00532389|"~     This study comprises of a dose-escalation and dose expansion phase and will determine the~     maximum tolerated dose of oral Panobinostat on a continuous schedule in adult in combination~     with bortezomib. Safety, tolerability, PK and PD profile of the combined treatments will be~     assessed as secondary objectives. Dose expansion phase will explore in a non continuous~     Panobinostat schedule with bortezomib and dexamethasone, safety and tolerability and PK~     profile of Panobinostat and Bortezomib with and without Dexamethasone~   "
231036|NCT00532376|"~     Depression is very common in epilepsy. Depression is the strongest predictor of poor quality~     of life in patients with epilepsy. The biological basis for depression in epilepsy remains~     poorly understood. This study uses functional MRI (fMRI) to examine brain response to~     emotional and non-emotional stimuli in healthy control subjects and in patients with epilepsy~     who are either depressed or not depressed. Results from this study will contribute to a~     better understanding of depression in epilepsy, which may eventually inform development of~     better treatment modalities..~   "
231037|NCT00532363|"~     Clinicians frequently observed that obese women referred for severe asthma do not respond to~     treatment. These patients, despite the presence of wheezing, often have normal expiratory~     flows and normal or borderline airway responsiveness.~      It is therefore possible that this mode of presentation reflect a pseudo-asthmatic state for~     which clinical definition and characteristics and optimal management remain to be determined.~      The aim of this study was to study the pulmonary physiological and airway inflammatory~     characteristics and response to treatment of obese women considered to have clinically severe~     asthma in order to demonstrate that some of these patients have a phenotype that is not that~     of asthma.~   "
231038|NCT00532350|"~     This study will assess the safety and tolerability of QAT370 compared to tiotropium in~     patients with COPD.~   "
231039|NCT00532337|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in~     postmenopausal women with osteopenia or osteoporosis.~   "
231052|NCT00532168|"~     There are few randomized clinical trials in advanced HIV patients. This is a multicenter,~     randomized, open clinical trial, comparing three parallel groups, to compare the~     immunological reconstitution and the virological efficacy and safety of three different~     combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine~     plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in~     advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3.~     Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting~     HAART.~   "
231040|NCT00532324|"~     Background:~      Community acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) is an emerging~     pathogen of the 21st century whose incidence as a cause of local and invasive infections has~     significantly increased, especially in previously healthy term and near term newborns. The~     etiology of the increasing incidence of infection in previously healthy term and near-term~     newborns remains unclear.~      Hypothesis:~        1. The incidence of previously healthy newborns infected with CA-MRSA skin & soft tissue~          (SSTI) and invasive infections is higher in those born to mothers colonized with~          CA-MRSA.~        2. Pregnant women colonized with CA-MRSA are at higher risk for post-partum infection with~          this organism.~      Specific Aims:~        1. To determine the incidence of nasal and vaginal colonization with CA-MRSA in pregnant~          women and determine the genetic similarities of these strains.~        2. To study CA-MRSA transmission dynamics and evaluate the incidence of SSTI and invasive~          infections in newborns born to S. aureus colonized mothers.~        3. To study the efficacy of attempted decolonization in CA-MRSA colonized mothers in~          decreasing the incidence of transmission and development of SSTI and invasive infections~          in their infants during the first month of life.~      Potential Impact:~      Understanding the epidemiology of the transmission dynamics of CA-MRSA in previously healthy~     newborns will provide important information to support the development of strategies aimed at~     the interruption of transmission and prevention of infection caused by CA-MRSA in newborns,~     as well as in pregnant women. This will also allow for the development of infection control~     strategies to prevent the spread of this organism among post-partum units and nurseries.~   "
231041|NCT00532311|"~     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily~     (QD), taken with statins on cholesterol levels in subjects with hypercholesterolemia~   "
231042|NCT00532298|"~     This observer blind study is designed to compare the immune response of GSK Biologicals'~     influenza vaccine GSK576389A when administered using various presentations in adults aged 65~     years and older. The Protocol Posting has been updated in order to comply with the FDA~     Amendment Act, Sep 2007.~   "
231043|NCT00532285|"~     This is an open labeled phase II single arm trial. The patients with clinical stage II and~     III will undergo core-needle biopsy of breast tumor for histologic diagnosis,~     immunohistochemical studies for estrogen receptor (ER), progesterone receptor(PR), HER-2/neu~     and others. PET or ultrasound results will determine the positivity of lymph node metastasis.~   "
231044|NCT00532272|"~     Primary objective is to evaluate the response rates and clinical benefits of letrozole +~     goserelin in premenopausal patients versus letrozole alone in postmenopausal patients with~     metastatic breast cancer as first line hormonal therapy~   "
231045|NCT00532259|"~     Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is~     the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL)~     following relapse of the disease. Although many people are cured of their lymphoma with this~     therapy, the disease comes back in a certain proportion of patients. The purpose of this~     study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients~     with DLBCL who have received autologous peripheral blood stem cell transplantation. All final~     eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post~     autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with~     treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be~     conducted throughout the study till 18 months post autologous PBSCT. Approximately 70~     patients will participate in this study.~   "
231046|NCT00532246|"~     The purpose of this study is to measure carotid artery IMT at a single visit in a subset of~     women previously enrolled in the CORE (H3S-MC-GGJY) trial~   "
231047|NCT00532233|"~     The purpose of this study is to investigate how QAX576 affects levels of interleukin 13~     (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).~   "
231048|NCT00532220|"~     BACKGROUND: Bone marrow edema (BME) in the knee occurs as a localized inflammatory disease in~     relation to spontaneous or non-traumatic osteonecrosis (ON). Prognosis of BME/ON in the~     course after knee arthroscopy appears to be poor and in most cases results in knee~     arthroplasty. Treatment options of ON depend in general on the size of the lesion. Smaller~     lesions are managed by mechanical unloading and use of non-steroidal anti-inflammatory drugs,~     larger lesion in general requires osteotomy or arthroplasty. In animal studies it has been~     shown that bisphosphonates prevent resorption of necrotic bone during ischemic necrosis and~     revascularization. In humans, bisphosphonate treatment has been used successfully in bone~     marrow oedema and avascular necrosis of the femoral head.~      In an observational study using bisphosphonates (ibandronate, pamidronate) in patients with~     either spontaneous or (believed to be) arthroscopy-induced BME of the knee a significant~     rapid and sustained pain relief was observed with a mean decrease on the pain scale on the~     visual analogue scale of over 60% after 3 months and of 80% after 6 months. Our experience~     suggests an apparent beneficial effect of amino-bisphosphonates in the treatment of BME of~     the knee.~      AIM: This randomized, double-blind, placebo-controlled study aims to provide data on~     clinical, biochemical and radiological outcome of patients with bone marrow edema in relation~     to spontaneous or arthroscopy-induced ON of the knee treated with ibandronate or placebo.~      ENDPOINTS: The primary objective is to demonstrate the superiority of treatment with~     ibandronate compared to placebo regarding clinical outcome (pain [VAS score]) in spontaneous~     or arthroscopy-induced BME/ON of the knee after 12 weeks. Secondary objectives include a)~     clinical outcome (pain [VAS score]) after 24 weeks, b) the evaluation of the radiological~     outcome (MRI scan) at 12 and 48 weeks, c) the changes in biochemical markers of bone~     turnover, and d) the number of salvage therapies needed in case persistence is observed~     during placebo therapy.~      METHODS: The study is designed as a single-center, randomized double-blind,~     placebo-controlled trial. A total number of 30 patients with BME/ON will be recruited. Each~     patient will be randomized in a 1:1 ratio to receive ibandronate IV or placebo IV.~     Additionally, all patients will receive 500 mg calcium and 400 IU vitamin D per day~     throughout the study, and diclofenac/esomeprazole for initial 3 months (blinded treatment~     duration 24 weeks). Baseline and follow-up data collection will contain all variables needed~     for evaluation of clinical, biochemical and radiological evaluation of treatment efficacy.~      EXPECTED RESULTS: We hypothesize that treating patients with BME/ON of the knee, therapy with~     ibandronate will be superior in reducing pain, and radiological findings as compared to~     placebo.~   "
231049|NCT00532207|"~     To see if using teriparatide for 12 months will increase Bone Mineral Density at the lumbar~     spine in postmenopausal women with osteoporosis~   "
231050|NCT00532194|"~     The purpose of this study is to assess the safety and efficacy of cediranib in combination~     with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or~     epithelial cancer, after first line platinum based treatment.~   "
231051|NCT00532181|"~     People who buy insurance are sicker and/or more risk averse than those who don't. Also,~     Micro-health insurance increases utilization of public health care facilities and protects~     against asset sales.~   "
231065|NCT00531999|"~     The purpose of the study is to look at the effects of two different HIV medications on the~     body's response to insulin (a hormone that regulates blood sugar levels). This will be done~     using a method called the 'euglycaemic clamp'~      The study will also investigate the effects of these drugs on blood fats and on circulating~     markers in the blood stream related to blood vessels (vascular inflammation markers).~   "
231053|NCT00532155|"~     The primary objective of the study was to demonstrate overall survival improvement for~     aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for~     participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).~      The secondary objectives were to compare other efficacy parameters, to assess the overall~     safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV)~     aflibercept in this participant population and to determine immunogenicity of IV aflibercept~     in all participants.~   "
231054|NCT00532142|"~     The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate~     the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone~     acetonide. 240 patients with a visual acuity < 0.5 Snellen will be randomised. Patients are~     treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide,~     or a placebo treatment - a sham injection of intravitreal triamcinolone. Patients will be~     examined regularly over a period of one year.~      Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein-~     and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed~     pre- and postoperatively.~   "
231055|NCT00532129|"~     This single arm study will assess the safety and effect on response rate of a combination of~     rituximab and chlorambucil in previously untreated participants with B-cell chronic~     lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment,~     followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of~     each cycle, at a dose of 375 milligrams per square meter (mg/m^2) intravenously (IV) in Cycle~     1, and 500 mg/m^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of~     each cycle at a dose of 10 mg/m^2/day per oral (PO).~   "
231056|NCT00532116|"~     Evaluate the effect of age on the PK of two different doses of EMSAM.~   "
231057|NCT00532103|"~     This study will develop a new methodology to evaluate any treatment-emergent suicidal~     ideation that might occur when an antidepressant treatment has been started and/or during~     times when doses are increased in patients with major depressive disorder.~   "
231058|NCT00532090|"~     This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of~     R4733 (RO4929097), administered orally to patients with refractory metastatic or locally~     advanced solid tumors. The study will assess three different dosing schedules; in one~     schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21~     day cycle, and in a third schedule continuously daily. The starting dose for each dosing~     regimen will be escalated in subsequent groups of patients after a satisfactory assessment of~     the safety and tolerability of the previous dose. The anticipated time on study treatment is~     until disease progression or dose-limiting toxicity, and the target sample size is 100-200~     individuals.~   "
231059|NCT00532077|"~     SB-751689 may alter calcium and phosphate handling at the kidney level. This study will~     examine what happens to calcium and phosphate, and other electrolytes, at the kidney after~     treatment with SB-751689 for 1 month. Another group of subjects will get another drug called~     Forteo for 1 month to compare the response of the kidney for calcium and phosphate.~   "
231060|NCT00532064|"~     Primary Objective:~      -To determine if specific biomarkers (Troponin I and B-type natriuretic peptide [BNP]) detect~     cardiotoxicity earlier than standard clinical means in patients receiving Sunitinib Malate~     (SU11248) or Sorafenib chemotherapy.~      Secondary Objective:~      -To prospectively evaluate the incidence and severity of cardiac toxicity related to~     sunitinib or sorafenib during chemotherapy.~   "
231061|NCT00532051|"~     The long-term goal of this project is to utilize very high-speed optical coherence tomography~     (OCT) technology to guide surgical treatments of corneal diseases. OCT is well known for its~     exquisite resolution, but until recently it has not had sufficient speed to capture the shape~     of the cornea because of eye motion during OCT scanning. The development of Fourier-domain~     (FD) OCT technology has made the requisite speed possible.~      The objective of this project is to develop methods for imaging the cornea with an FD-OCT~     system that will precisely measure corneal shape and use this information to guide surgery.~     Cataract surgery in patients with previous laser vision correction often leads to significant~     near- or far-sightedness, a problem that could be resolved by using a more accurate~     intraocular lens power selection formula based on the measurement of corneal refractive power~     with OCT.~   "
231062|NCT00532038|"~     ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD~     (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated~     with osteoarthritis. This study will evaluate the safety of long-term administration of~     ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study~     will be conducted in patients with pain associated with osteoarthritis and who have completed~     a previous efficacy study of ThermoProfen.~   "
231063|NCT00532025|"~     This is an open-label, single-armed, multicentric, phase II study of Sorafenib treatment~     following surgery for NSCLC.~      The primary hypothesis is to increase the progression-free survival (PFS) of the experimental~     group in comparison to a historical control group. For sample size calculation a 2 year PFS~     of 50% was calculated for the historical control group, and a 2 year PFS of 67% was estimated~     for the intervention group. These estimates are based on the actual PFS and overall survival~     (OS) of a defined population of 120 NSCLC patients treated at a single institution with~     surgery alone or surgery followed by adjuvant radiotherapy, which compares favorably to~     published international results, and the improvement of PFS achieved by 4 cycles of~     cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.~   "
231064|NCT00532012|"~     The drug that is under investigation during this study is RhuDex® and is expected to be used~     as an oral treatment for rheumatoid arthritis. Normal stomach juices contain acid and~     previous studies have shown that this acidity reduces the solubility and therefore the~     absorption of RhuDex®. Administering the alkaline buffer meglumine with RhuDex® has shown to~     increase the solubility of RhuDex® by decreasing the stomach acidity.~      The purposes of this study are to determine:~        -  the optimum level of meglumine which is required to achieve the best uptake of RhuDex®~          from the stomach into the blood~        -  to determine the concentration of RhuDex® in the blood in the presence of the optimum~          level of meglumine~        -  to investigate further the safety and tolerability of RhuDex®. The study will be~          conducted in healthy male volunteers.~   "
231066|NCT00531986|"~     The investigators plan to conduct a two arm study, to compare failure rates in the central~     nervous system (CNS) and genital compartment in virologically fully suppressed patients~     continuing a highly active antiretroviral therapy (HAART) versus patients switching to~     ritonavir boosted lopinavir (Kaletra®) HIV-monotherapy. The study is composed of two phases~     of 48 weeks duration.~      In addition, neuropsychological tests (Color trial test A 1 and 2; Grooved pegboard; EWIA~     Digit Symbol form) and evaluation of side effects will be performed.~   "
231067|NCT00531973|"~     The randomized LITE study will compare liposomal doxorubin versus standard epirubicin in the~     treatment of female breast cancer. In order to detect as early as possible post-chemotherapy~     cardiotoxicity, tissue Doppler imaging parameters elicited at transthoracic echocardiography~     will be used and will constitute the primary and co-primary end-points.~   "
231068|NCT00531960|"~     This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and~     chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small~     cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus~     Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus~     Avastin. The anticipated time on study treatment is until disease progression, and the target~     sample size is 100-500 individuals.~   "
231069|NCT00531947|"~     The primary purpose of your participation in this study is to help answer the following~     research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is~     safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major~     Depressive Disorder (MDD).~   "
231070|NCT00531934|"~     This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with~     non-small cell lung cancer who have failed first-line chemotherapy for advanced disease.~     Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no~     preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated~     time on study treatment is until disease progression or intolerable toxicity, and the target~     sample size is 100-500 individuals.~   "
231071|NCT00531921|"~     Activity of genes in donor tissues that are involved in inflammation are thought to be~     involved with early organ dysfunction, increased immune responses in transplant recipients,~     and organ rejection. The purpose of this study is to determine the relationship between~     genetic expression in donor and recipient tissue with transplant survival. Participants in~     this study will have received heart, lung, liver, or kidney transplants.~   "
231072|NCT00531908|"~     Acromegaly is a disease due to an excess of growth hormone that abnormally occurs in~     adulthood. It is due to a benign (non cancerous) tumor located in a particular part of the~     brain that secretes several hormones, the hypophysis. The excess of growth hormones in adults~     induces an increase in bone (resulting in large enlargement of extremities), and organs. The~     disease is complicated by the apparition of cardiovascular events including retention of~     water, salt in the tissues and increase in blood pressure, that altogether might major the~     mortality of the patients. The investigators recently got experimental data suggesting that~     the retention of water and salt is mainly due to the activation by the growth hormone of a~     renal transporter of sodium. Because this transporter is highly sensitive to amiloride, a~     well know diuretic, the investigators hypothesize that this drug will be very efficient in~     treating the hypertension in patients, as compared to another diuretic, furosemide.~   "
231073|NCT00531895|"~     Background: Although major depression and chronic headache are strongly associated, there is~     insufficient evidence on the use of antidepressants for this specific comorbidity. This trial~     aimed to investigate the efficiency and tolerability of duloxetine for this indication.~      Methods: Thirty outpatients of our clinic, with DSM-IV major depression and concurrent~     primary chronic headache (chronic migraine, chronic tension-type headache or both), 18-55~     years, were recruited from April 2006 to March 2007, if they scored >21 on the~     Montgomery-Äsberg Depression Scale (MADRS) and had no other significant clinical condition.~     Subjects received duloxetine 60 mg/day for 8 weeks. MADRS scores and a visual analog pain~     scale (VAS) were the co-primary outcome measures. WHO quality of life scale (WHOQoL BREF)~     scores and headache days/week were secondary outcome measures.Conclusion: In this preliminary~     open trial, duloxetine 60 mg/day was effective, fast acting and well tolerated for the~     treatment of comorbid major depression and chronic headache.~   "
231074|NCT00531882|"~     Inflammation clearly contributes to the progression of the cystic fibrosis (CF) lung disease,~     and administration of the anti-inflammatory agent high-dose ibuprofen retards the rate of~     decline of pulmonary function. However, utilization of this valuable drug has been suboptimal~     because of its rare, but dramatic, adverse effects. Therefore, alternative anti-inflammatory~     agents are urgently needed. One strategy for identifying new anti-inflammatory agents is to~     determine the mechanism by which the only proven anti-inflammatory agent for the CF lung~     disease, high-dose ibuprofen, exerts its effect. If this were known, then other drugs that~     act by a similar mechanism become candidates for treating the CF inflammatory disease. The~     investigators have shown, in our preliminary studies, that high dose ibuprofen limits the~     delivery of neutrophils to an inflamed mucosal surface, the gingival crevices. The~     investigators plan to test pioglitazone and simvastatin, (ibuprofen (positive control)) to~     determine their anti inflammatory affects on neutrophil migration to the oral mucosa.~      The hypothesis to be tested is that pioglitazone, and/or simvastatin will reduce neutrophils~     in the oral mucosa after 10 days of therapy in mouthwashes of healthy volunteers. Ibuprofen~     will be used as a positive control.~      This study will provide pilot data from healthy volunteers to support an FDA Grant to be~     submitted at a future date.~   "
231075|NCT00531869|"~     Consumer preferences for POU technologies vary across consumers and products, and largely~     determine their adoption and subsequent usage. This is a marketing study that asks which~     products consumers prefer and why, and what is their willingness to pay, as understanding~     this is crucial to attain their widespread adoption and usage.~   "
231076|NCT00531856|"~     The purpose of this study is to evaluate the safety and tolerability of two carbon monoxide~     doses when administered as an inhaled gas for 1 hour in patients receiving kidney~     transplants.~   "
231168|NCT00530608|"~     The pulmonary veins are the predominant sources of AF induction and maintenance. This study~     aims to assess the electrophysiological properties of the pulmonary veins and their relation~     to AF in humans.~   "
231077|NCT00531843|"~     Trauma patients are at high risk of developing deep vein thrombosis (DVT) and pulmonary~     embolism (PE). The incidence of DVT varies greatly from 5-63% among studies depending on~     patient's individual risk factors, modality of prophylaxis, and methods of detection. The~     incidence of PE may be as low (0.3-4.3%) but carries a mortality of 20-50% which makes~     prevention of DVT of the utmost importance. The current standard of care for DVT prophylaxis~     in the trauma patient with high risk of DVT is enoxaparin, a low molecular weight heparin,~     administered twice a day as long as anticoagulation in not contraindicated. Many studies have~     demonstrated its efficacy when compared to mechanical compression and to unfractionated~     heparin, however one of the most robust of these studies still reported an DVT incidence of~     35% in patients treated with enoxaparin. Another drug, fondaparinux, is a selective factor Xa~     inhibitor that could offer added benefits over enoxaparin such as once daily dosing and a~     drastically reduced risk of heparin induced thrombocytopenia (HIT). Fondaparinux has been~     already be widely used in post-operative hip surgery and major knee surgery patients with~     good results. It has also been shown to be effective in DVT prophylaxis in patients who have~     had major abdominal surgery and also in acute medical patients. Fondaparinux has yet to be~     used in trauma patients. Trauma patients are a diverse and distinct population given the~     acuity of their injuries and their increased risk of bleeding who at this time still do not~     have a perfect method for DVT prophylaxis. We hypothesize that fondaparinux will be effective~     in decreasing the risk of DVT when used in the trauma patient population. This is a non~     randomized prospective cohort study designed to test the efficacy of fondaparinux in the~     prophylaxis of DVT and PE in trauma patients.~   "
231078|NCT00531830|"~     The aim of the current research is to assess the efficiency of the Integrative Therapy among~     children with PDD after a year of treatment in kindergartens in Ashdod, Israel.~      An additional aim is to pinpoint specific changes in communication quality and functioning in~     different areas and recognize the prognostic factors, such as social interaction, affect and~     level of play. This analysis will contribute to developing more efficient treatment program,~     adapted to the needs of the treated children.~   "
231079|NCT00531817|"~     This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in~     combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in~     signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an~     inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either~     tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also~     received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on~     study treatment was 3-12 months and the target sample size was 500+ individuals.~   "
231080|NCT00531804|"~     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to~     receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting~     dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a~     satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose.~     The anticipated time on study treatment is 3-12 months, and the target sample size is <100~     individuals.~   "
231081|NCT00531791|"~     Short course of steroids in COPD exacerbation improves FEV1 and decreases the relapse rate.~     However, some concerns remain about using systemic steroids for all patients with acute~     exacerbation. Their short-term advantages may be outweighed by the occurrence of adverse side~     effects such as hyperglycemia, which is difficult to manage on an outpatient basis. In this~     context, the possibility of treating patients with COPD exacerbation with inhaled steroids~     having less systemic adverse effects is interesting. The objectives are to compare relapse~     rate, lung function, the severity of dyspnea and, systemic and sputum inflammatory markers in~     outpatients with acute COPD exacerbations treated with fluticasone/salmeterol (Advair®) or~     oral prednisone for 10 days. The hypothesis is that Advair® is as effective as prednisone in~     treatment of outpatients with COPD exacerbation. The primary endpoint is to determine if the~     relapse rate at one month is equivalent for both treatments. The secondary endpoints are to~     compare lung function and dyspnea score and, systemic and sputum inflammatory markers~     modulation after 10 days of both treatments. We will recruit 30 outpatients in each group~     from our COPD clinic. Patients will receive prednisone (40mg/day) with placebo diskus or~     Advair® 50/500ug 2 inhalations bid (twice the regular dose) with placebo pills for 10 days.~     All patients will receive antibiotics and short-acting bronchodilators as needed. We expect~     to demonstrate that the improvement of lung function, dyspnea, inflammatory markers and~     relapse rate are equivalent in both treatments suggesting that Advair® could be a good~     alternative to prednisone for patients with steroid-induced hyperglycemia.~   "
231082|NCT00531778|"~     Improving current strategies for detection of early stage disease can impact favorably on~     long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of~     ovarian cancer, screening for this disease must detect early stage disease rather than~     advanced stage disease. Thus the challenge for the future is to identify and develop highly~     sensitive and specific tumor markers that can be applied to population-based screening for~     the early detection of ovarian cancer.~   "
231083|NCT00531765|"~     We plan to conduct an open-label, randomized, stratified, parallel-group study to compare~     normal saline infusion to sodium bicarbonate infusion.~   "
231084|NCT00531752|"~     The purpose of this study is to determine whether PF-03654746 is effective in the treatment~     of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized,~     double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment~     with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg),~     and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants~     will be required to washout of prior ADHD medication before entering the study. Participants~     will be required to come to the site for 10 visits over approximately a 10-week period.~   "
231085|NCT00531739|"~     The purpose of this study is to determine if the use of SurgiWrapTM: (1) prevents/lowers the~     incidence of Grade 2 or higher soft tissue attachments under the incision made during~     abdominal surgery, (2) reduces post-operative bowel obstruction.~   "
231086|NCT00531726|"~     In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20~     patients with treatment resistant major depression will be investigated. In addition, the~     stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will~     be assessed.~   "
231087|NCT00531713|"~     To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with~     autoimmune hypothyroidism, on stable T4-substitution therapy~   "
231185|NCT00530374|"~     The purpose of this study is to determine the safety profile of oral iron supplementation~     (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID)~     and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated.~   "
231088|NCT00531700|"~     The purpose of this project is to evaluate the effects on influenza related knowledge,~     attitudes and behaviors of exposure to tailored/targeted health messages and contextualized~     information about influenza like illness delivered to subjects through a personally~     controlled health record system. The main study hypothesis is that exposure to more intensive~     levels of personalized and contextualized information about risk will result in increased~     knowledge about influenza, greater attributions of immunization safety and efficacy, improved~     health protecting behaviors including higher levels of appropriate immunization.~   "
231089|NCT00531687|"~     Study Objectives:~      Primary objective~        -  The primary objective of this study is to investigate the combination of~          cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with~          germ cell tumours previously treated with BEP.~      Secondary Objectives~        -  Overall survival~        -  Progression free survival~        -  Response rates (RECIST)~        -  Duration of response~        -  To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients~          previously treated with BEP~   "
231090|NCT00531674|"~     The Mexican poverty alleviation program, Oportunidades provides a fortified food supplement~     to all beneficiary children under 2 years of age, and all pregnant and lactating women.~     Consumption of the supplements is well below recommended levels and the impact of the program~     on child growth and anemia is less than anticipated. This is likely due to a high degree of~     dilution by sharing of the supplements with other family members. We have also found evidence~     of a very high prevalence of overweight and obesity among beneficiaries of Oportunidades in~     both women and children.~      Given the micronutrient content of the fortified food, it is likely that the impact of the~     program on child growth and the micronutrient status of women and children would improve~     considerable if the supplements were consumed daily in the recommended dose. This may be~     difficult, given the wide-spread sharing within households - something that has been~     identified by many beneficiary families as a desirable behavior. At the same time, we do not~     know whether daily consumption of the food, which contains approximately 20% of daily energy~     requirements, may contribute to undesirable weight gain in this population.~      In this context, we have designed a cluster randomized controlled efficacy trail to compare~     the nutritional impact, acceptability and use of three nutritional supplements. Supplements~     were randomly assigned at the community level (n=54), and pregnant women (n=750) and children~     6 to 12 mo of age (n=900) invited to participate. The principal objective of the study is to~     compare the impact of Sprinkles and Nutrisano/Nutrivida using syrup/pills as a positive~     control group, on child growth, weight gain and retention in pregnant women, and~     micronutrient status of women and children. We hypothesize that weight gain will be greater~     in the food group compared to the other two supplementation groups, but impacts on~     micronutrient status and length growth in children will be similar.~   "
231091|NCT00531661|"~     This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the~     United States (US). The objective of the study is to evaluate the safety and efficacy of the~     HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a~     subset of subjects suffering from HF.~   "
231092|NCT00531648|"~     The researched attends to observe the relationships between toddlers that were diagnosed as~     SPD and as having feeding disorder (by DSM-R-IV)and their parents.~   "
231093|NCT00531635|"~     Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC~     Infusion and post transplant in immunosuppression w/CSA & Mycophenolate Mofetil~   "
231094|NCT00531622|"~     The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in~     combination with escitalopram 10mg once daily compared to saredutant placebo in combination~     with escitalopram 10mg once daily in patients with major depressive disorder. This study also~     includes a double-placebo group (saredutant placebo in combination with escitalopram~     placebo).~   "
231095|NCT00531596|"~     Examine adhesive and dermal tolerability of EMSAm 6mg/24hr and 12mg/24hr in healthy elderly~     and non-elderly subjects.~   "
231096|NCT00531583|"~     Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem~     cell transplantation program for pts w/AML in 1st & 2nd complete remission w/no HLA matched~     related donor~   "
231097|NCT00531570|"~     In the United States, ovarian cancer is the fifth most common cancer to develop in women and~     causes more deaths than all other gynecologic malignancies combined. Because of the~     difficulties in detecting early stage ovarian cancer, 75% of women continue to be diagnosed~     with advanced stage disease (stage III or IV).~      The National Ovarian Cancer Early Detection Program (NOCEDP) as part of the National Cancer~     Institute's Early Detection Research Network (EDRN) is committed to the development of~     effective means for the accurate detection of early stage ovarian cancer.~      The last decade has seen rapid technological advances in diagnostic ultrasonography with the~     recent development of three-dimensional imaging.~      Initial studies suggest that these new technologies improve upon the diagnostic accuracy of~     two-dimensional transvaginal imaging in the differentiation between benign and malignant~     pathology.~      This improved diagnostic accuracy may promote improved patient care by separating complex~     benign masses from ovarian cancer therefore facilitating appropriate treatment.~   "
231098|NCT00531557|"~     The purpose of the study is to study the effects of switching from an antiretroviral~     combination that includes two ritonavir boosted protease inhibitors to replacement of these~     two protease inhibitors with a new protease inhibitor called Darunavir (also boosted with~     ritonavir).~      The study will investigate the effect of the switch on viral load (the levels of the HIV~     virus in the blood), on immunological parameters (CD4 count) and on other safety parameters~     and also on quality of life.~      In a subgroup of patients the impact of the switch on the body's response to the hormone~     insulin will also be measured (Euglycaemic clamp sub group)~   "
231099|NCT00531544|"~     A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal~     Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may~     derive benefit from treatment with SU011248~   "
231120|NCT00531258|"~     Depression is very common in people who have experienced a traumatic brain injury. Few~     treatments have been found to be effective in treating depression in this situation. We~     intend to investigate the effectiveness of a form of brain stimulation, transcranial magnetic~     stimulation, which has been found to be effective in treating depression in people who have~     not undergone a brain injury. By evaluating new methods of treating depression in this~     population, we hope to increase the options available for treating people in this difficult~     situation. Furthermore, problems with aspects of thinking are also commonly present post~     brain injury, as in some individuals with depression. Various brain stimulation techniques,~     including transcranial magnetic stimulation (TMS) have been shown to have a positive effect~     on cognition. We also intend to investigate whether a therapeutic effect on cognitive~     deficits is present following TMS, in addition to any effects on depression. New treatment~     protocols will be developed, and understanding of the pathology and treatment of post~     traumatic brain injury depression will be enhanced.~   "
231100|NCT00531531|"~     It is well known that an association exists between the acquisition of some respiratory~     pathogens and prognosis of CF people. About 57 % of patients has a lung infection due to~     P.aeruginosa (PA). Transmission of PA between CF patients is possible and several prevention~     measures are recommended. Among these measures, all international guidelines recommend that~     CF people maintain a minimum distance of 1 meter between them. However, this recommendation~     is not supported by specific studies and scientific evidence. In other words, the~     investigators don't know if this measure is sufficient or excessive, as it is based only on a~     theoretical rationale.~      This study aims at measuring experimentally the distance that can be reached by PA emitted~     from airways of colonized CF patients during cough and during conversation.~      To this purpose, the investigators will evacuate the presence of PA on surfaces placed at 4~     different distances from patients, through the collection of 8 swabs, 4 of which following~     cough and 4 following conversation. Swabs will be collected on sterile surfaces comprised~     between tra 0 - 0,5 mt; 0,5 -1,00 mt.; 1,00 - 1,5 mt and 1.5-2 mt.~      All the PA-positive CF patients of the CF Centre of Tuscany aged 14 or more will be~     recruited.~   "
231101|NCT00531518|"~     EDIPP is a multisite trial of early identification and intervention to prevent the onset of~     psychosis in adolescents and young adults, carried out at six sites across the United States.~     The hypothesis is that very early identification and intervention will be effective in~     delaying or preventing onset of psychosis and improving social and occupational functioning.~   "
231102|NCT00531505|"~     1. Briefly describe the purpose of this protocol. First purpose of the study is to~          understand the inheritance of morbid obesity.~        2. Briefly summarize how participants are recruited. Volunteers will first learn of LABS-2a~          research opportunity at the Bariatric Surgery Informational meetings.~        3. Briefly describe the procedures subjects will undergo.~           Participants will be asked to complete a set of memory tests. Fat and Liver samples will~          be removed during their weight loss surgery, specifically for this research study.~        4. If applicable, briefly describe survey/interview instruments used. Memory tests will be~          performed to assess cognition.~        5. Briefly describe how the data will be analyzed to address the purpose of the protocol.~      The memory test data collected and compared against well established norms. Tissue samples~     will stored in a repository to be genetically studied for an indefinite amount of time.~     Genetic studies will be related to the disease of obesity and associated comorbidities~     brought on by the disease.~   "
231103|NCT00531492|"~     The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low~     birth weight (LBW) infants and their mothers started as soon as possible within 24 hours~     after birth in developing country.~      For the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours)~     contact between LBW infants and their mothers or any other people who substitute mothers.~   "
231104|NCT00531479|"~     This study compares the effectiveness and safety of the combination of anidulafungin and~     voriconazole compared to that of voriconazole alone (which is generally considered the~     standard of care) for the treatment of Invasive Aspergillosis.~   "
231105|NCT00531466|"~     A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following~     a spinal cord injury. This study has three purposes:~        1. To determine whether AV650 is safe for patients with spinal cord injury;~        2. To assess what the body does with AV650 once it is ingested; and,~        3. To gather some early evidence as to whether AV650 is effective in treating spasticity in~          patients with spinal cord injury.~   "
231106|NCT00531453|"~     The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of~     treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE,~     dexamethasone, thalidomide, and cyclophosphamide (VDTC) in subjects with newly diagnosed~     symptomatic multiple myeloma who have received no prior treatment and are candidates to~     receive high-dose therapy and autologous bone marrow/stem cell transplantation.~   "
231107|NCT00531440|"~     This extension study is designed to provide long-term safety and efficacy data beyond 12~     months up to Month 36.~   "
231108|NCT00531427|"~     The objective of this study is to determine the analgesic efficacy and safety of~     Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve~     subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The~     double-blind treatment intervention duration is 12 weeks, during which time supplemental~     analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and~     acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to~     all subjects in addition to study drug.~   "
231109|NCT00531414|"~     The OsmohalerTM is a registered device in Australia. It is used to deliver a dry powder a~     commercial preparation of mannitol registered as AridolTM to test if a person has irritable~     airways such as active asthma.~      The overseas regulatory authorities need to know that people of all ages can achieve an~     adequate inspiratory flow through this device during a controlled deep inspiration. Adequate~     flow is generally regarded as greater than 30 litres per minute in children and 60 litres per~     minute in adults. The OsmohalerTM is a device with low resistance and is already in use in~     Australia to deliver mannitol. However there is a need to document inspiratory flows through~     the device during a controlled deep inspiration. The protocol requires subjects to perform a~     controlled deep inspiration from the device on three or five occasions. No substance will be~     inhaled.~   "
231110|NCT00531401|"~     The purpose of this study is to determine whether Salirasib is effective to shrink or prevent~     the growth of the tumors associated with non-small cell lung cancer in both patients who are~     newly diagnosed or have recurrent disease.~   "
231111|NCT00531375|"~     The primary purpose of this study is to investigate the effect of silicone hydrogel contact~     lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to~     compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.~   "
231141|NCT00530985|"~     To test the hypothesis that veterans counseled around managing their benefits will work more~     and have a better quality of life than those receiving non-specific counseling.~   "
231142|NCT00530972|"~     To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in~     patients who have relapsed or not responded to a previous suboptimal therapy based in~     Interferon.~   "
231143|NCT00530946|"~     To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in~     Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period~   "
231112|NCT00531362|"~     Aspirin is an essential drug for the treatment of cardiovascular disease. The standard dose~     is 75mg per day (much lower than that for inflammation or fever). One of the side-effects of~     aspirin is a gastric ulcer which can be fatal. To prevent this it is common to use~     enteric-coated aspirin. This passes through the stomach intact and dissolves in the~     intestines. This prevents high levels of drug forming in the stomach reducing ulcer~     formation. Recently there is evidence of high levels of aspirin resistance, ie, patients who~     appear not to achieve the maximum benefit from aspirin. Clinical studies have shown a~     significant increase in mortality among these patients.~      A recent study that we performed showed that enteric-coated aspirin is not as effective as~     plain aspirin. This was especially noticeable in heavier volunteers. In fact it appeared that~     enteric-coated aspirin only delivers 50mg aspirin instead of the full 75 mg. For volunteers~     resistant to enteric-coated aspirin simply switching them to plain aspirin solved the~     problem.~      We propose to recruit patients on 75 mg enteric aspirin and test them for evidence of poor~     response to aspirin. Poor responders will then be given 75mg plain aspirin and tested for~     their response. Those that fail to respond will then receive 150 mg aspirin. If the results~     of the healthy volunteer study are replicated this would provide a very cheap and effective~     solution to a serious problem.~   "
231113|NCT00531349|"~     The purpose of this study is to determine whether recurrence of local and metastatic cancer~     after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive~     epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane~     anesthesia and opioid analgesia.~   "
231114|NCT00531336|"~     The first results of Anti-Vascular Endothelial Growth Factor (VEGF) therapy were very~     promising and superior to established therapies. Three different substances (all of them~     applied intravitreally) are available, but comparative studies have not yet been conducted.~     In this pilot study, the safety (number of adverse events) and efficacy (distance acuity~     testing retinal thickness measurement) of Avastin and Macugen applied as monotherapy will be~     compared to a combined treatment of Avastin followed by Macugen used for retreatment.~      At least equal results of the combined therapy are expected.~   "
231115|NCT00531323|"~     The purpose of the study is to look at whether changing directly from one medication for HIV~     (efavirenz) to a new medication for HIV (TMC125) has any effect on the levels of TMC125 in~     the blood, compared to when TMC125 is taken without efavirenz having been taken immediately~     beforehand.~      The study aims to help the investigators understand whether it is safe to change directly~     from efavirenz to TMC125 (with no gap between the treatments) in patients who need these~     treatments.~      The study will investigate the blood levels of TMC125 when it is taken both once and twice a~     day.~   "
231116|NCT00531310|"~     CML, a malignant disorder of stem cells, is characterized by increases in both immature and~     mature myeloid, erythroid, and lymphoid cells, as well as platelets in the peripheral blood.~     The cytogenetic hallmark of CML is the Philadelphia(Ph)chromosome found in the malignant~     cells of 95% of patients. CML comprises 7-20% of all leukemias with an overall incidence in~     the general population estimated at 1 to 2 per 100,000. The peak incidence occurs in the~     fifth decade, however, all age groups, including children, are affected. The only reported~     environmental risk factor is exposure to excessive ionizing radiation that is documented in~     only a very small percentage of patients. Clinically, CML is characterized by an initial~     chronic phase in which patients may report mild constitutional symptoms; however, 40-50% are~     asymptomatic and are diagnosed based upon abnormal blood counts discovered during a routine~     examination. The chronic phase typically lasts three to five years, and is followed by an~     accelerated phase distinguished by progressive systemic symptoms, an increasing resistance to~     conventional chemotherapy, and a rise in the peripheral blood and bone marrow blast count.~     This evolves rapidly into a blastic crisis characterized by immature cells resembling the~     blasts characteristic of acute leukemia. The presence of 30% or more blastic cells in the~     blood or marrow is diagnostic of this final blastic phase which is typically fatal within 3~     to 6 months.~      The primary treatment options for CML have traditionally been monotherapy with either~     busulfan or hydroxyurea. Both agents are able to control the clinical symptoms associated~     with CML, as well as induce hematological remissions in 80% of chronic phase patients.~     However, complete cytogenetic remissions with either agent are rare, and neither is able to~     prevent eventual progression to the terminal blastic phase; therefore, these therapies can~     only be considered palliative.~      The primary purpose of this clinical research trial is to study the feasibility of a reduced~     intensity allogenic transplant for CML. This study will also determine the side effects as~     well as the response rate.~   "
231117|NCT00531297|"~     Any efforts to spare patients with T1 carcinomas of the rectum from low anterior resection or~     even abdominoperineal resection are linked to the risk of locoregional recurrence of about~     10% (range, 0-24). This is tolerated in the view of the morbidity and mortality risk related~     to transabdominal resection, which is as high as 7-68% and 0-6.5%, respectively. Accordingly,~     in addition to transanal local excision various adjuvant therapy schemes with chemo- and/or~     radiotherapy were developed, given the uncertainty about the lymph node stage. Another~     approach was to identify histological risk criteria in the primary tumor in terms of defining~     the limits of rectum-sparing therapy.~      In earlier experimental and clinical studies the investigators researched and applied~     dorsoposterior extraperitoneal pelviscopy, i.e. perineal access to the soft-tissue areas of~     the minor pelvis using minimally invasive surgery. in T1 carcinoma of the rectum this~     technique becomes all the more significant, as the perineal approach makes it possible to~     perform an endoscopic posterior mesorectal resection (EPMR) in combination with~     rectum-sparing surgery Thereby the relevant lymphatic field of the lower rectum can be~     removed and histologically examined. As a consequence EPMR should lower the loco-regional~     recurrence rate, since the most common causes of such are pre-existent but so far not~     detectable lymph node metastases besides the incomplete resection of the primary tumor.~   "
231118|NCT00531284|"~     The primary objectives of this Phase 1b/2 study were as follows:~        -  Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in~          patients with relapsed solid tumors and in patients with relapsed and/or refractory~          multiple myeloma and in patients with refractory lymphoma.~        -  Phase 2 (Bolus): To evaluate the overall response rate (ORR) after 4 cycles of~          carfilzomib in patients with relapsed solid tumors.~   "
231119|NCT00531271|"~     To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008~     giver every 3 weeks; to characterize the toxicities of ABI-008; and to determine the~     pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule to patients~     with metastatic breast cancer.~   "
231144|NCT00530933|"~     The purpose of this study is to determine whether tibial nerve stimulation is an effective~     treatment for faecal incontinence.~   "
231145|NCT00530920|"~     The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV)~     and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be~     used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy~     and safety~   "
231121|NCT00531245|"~     Capecitabine and oxaliplatin(XELOX) is active first-line therapy for patients with metastatic~     colorectal cancer. Phase II study of TS-1, a novel oral fluoropyrimidine derivative, showed~     activity in patients with metastatic colorectal carcinoma. Preclinical data of TS-1 with~     oxaliplatin showed synergistic activity in vivo human colorectal cancer xenograft. There is~     no data about the optimal dose of TS-1 with 2 weeks schedule combined with oxaliplatin.~     Therefore in a phase I study, we would like to determine the maximum tolerated dose(MTD) of~     TS-1 and oxaliplatin and define the recommended dose for subsequent phase II study. And then,~     in a phase II study we would like to evaluate the efficacy(response rates) and toxicities of~     the new combination regimen in advanced colorectal cancer.~   "
231122|NCT00531232|"~     There is no well accepted standard care for patients who fail or are intolerant to any of the~     currently approved therapies for Myelodysplastic Syndromes (MDS). In this study, patients~     will be assigned to receive 25mg of oral clofarabine daily for 5 days. Patients may receive~     up to 8 cycles of treatment with clofarabine as long as the patient continues to benefit and~     in the absence of progressive disease.~   "
231123|NCT00531219|"~     This is an observational study of pain and outcomes from patients undergoing transgastric~     NOTES removal of their appendix or gallbladder. Subjects who elect to have a transgastric~     NOTES removal of their appendix or gallbladder and agree to be in this study (through~     signature on the informed consent form) will be followed per standard of care, with~     additional follow-up for data collection including the following:~        -  Subjects will complete a 7 day pain/temperature log after surgery~        -  Subjects will receive a phone call at 6 months and at 1 year after surgery to capture~          data related to safety, adverse events, hospitalizations and patient satisfaction~      Additional data related to pain and outcomes will be collected at baseline/screening and at~     follow-up as necessary.~   "
231124|NCT00531206|"~     This observational study is supposed to assess (under conditions of clinical practice in~     daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose~     Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load~     below the limit of detection.~   "
231125|NCT00531193|"~     To establish the extent to which BIIB014, following 8 to 12 consecutive days of dosing at~     selected dose levels, occupies the brain's A2A receptors. Receptor occupancy will be assessed~     by PET scanning using a radiolabelled tracer.~   "
231126|NCT00531180|"~     Objectives:~      Primary Objective:~      1. To determine the correlation between 4-dimensional computed tomography (4D CT) derived~     ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined~     ventilation.~      Secondary Objective:~        1. To evaluate the reproducibility of the 4D CT derived ventilation and to obtain an~          estimate of the variance in a single setting.~        2. To assess the correlation between hypoperfused and hypoventilated pulmonary regions in~          patients with thoracic malignancies.~        3. To investigate the effect of continuous positive airway pressure (CPAP) on ventilation~          and tumor motion.~   "
231127|NCT00531167|"~     Antiviral resistance mutations limit the efficacy of therapy for chronic hepatitis B. At year~     2, resistance to adefovir may occur as high as 25% in patients with history of lamivudine~     resistance. Resistance to entecavir is reported to be 10% in lamivudine refractory patients~     during the same period. However, combination of lamivudine and adefovir decreased the~     adefovir resistance rate as low as 0% in the recent studies. By overcoming the antiviral~     resistance, the efficacy of therapy will be maximized. This study is intended to compare the~     efficacy of two strategies, combination of lamivudine and adefovir vs. entecavir monotherapy~     in patients with lamivudine resistance.~   "
231128|NCT00531154|"~     The aim of this study is to investigate whether there was an association between obesity and~     periodontitis, tendency to caries and periapical lesions.~      People who have a higher body mass index produce cytokines (hormone-like proteins), that lead~     to systemic/chronic inflammation (like periodontitis and periapical lesions), and obesity~     related dietary habits could result in an increment of dental caries because both the amount~     and the frequency of sucrose ingestion are important factors associated with the aetiology of~     the oral disease.~   "
231129|NCT00531141|"~     The Optical Coherence Tomography (OCT) is a non-contact, non invasive method to examine the~     retina by providing cross-sectional scans through the retina. Measurements of the retinal~     thickness based on automatically set border lines created by threshold algorithm provide~     information concerning the amount of intraretinal fluid and activity of the lesion. In this~     study the reproducibility of retinal thickness measurements in patients suffering from~     age-related macular degeneration performed by two independent examiners of two examinations~     of the same day but performed in a time interval of at least two hours should be evaluated.~     Using the macular thickness program of stratus OCT, 6 radial lines through the center of the~     foveal avascular zone are performed, Differences between the first and second measurement~     will be investigated by a 95% confidence interval, a Bland-Altman plot (with corresponding~     regression analysis) and a random effect model with time, examiner and diagnosis as fixed~     factors. Although threshold algorithm failures and fixation problems are common in~     age-related macular degeneration evidence of reproducibility and repeatability of maximum~     retinal thickness is expected.~   "
231146|NCT00530907|"~     The goal of this clinical research study is to find the highest tolerable dose of bevacizumab~     in combination with valproic acid that can be given to patients with advanced cancer that has~     not responded to standard treatment or where there is no standard treatment for the disease.~     The safety of this drug combination will also be studied.~   "
231147|NCT00530894|"~     The purpose of this study is to determine the safety and effectiveness of the device and~     delivery systems (transfemoral and transapical) in high risk, symptomatic patients with~     severe aortic stenosis.~   "
231148|NCT00530881|"~     This will be a 4-week, multicenter, randomized, double-blind, parallel group,~     placebo-controlled, safety, tolerability, and efficacy study. Patients will be screened and~     be on one of three doses of PHX1149 (a new drug candidate for the treatment of Type 2~     diabetes ) or placebo. The drug is a DPP4 inhibitor~   "
231149|NCT00530868|"~     This purpose of this trial is to show that the combination of Avastin and hormone therapy~     should be more effective than hormone therapy alone for the treatment of breast cancer.~   "
231150|NCT00530855|"~     This open-label extension trial will assess the long-term use of Lacosamide monotherapy and~     safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset~     seizures who were previously enrolled in the conversion to monotherapy trial (SP902).~   "
231130|NCT00531128|"~     This study will determine if dietary supplements of sitosterol (a plant cholesterol commonly~     found in vegetables) can modify blood sugar and cholesterol levels and reduce the stiffness~     of the blood vessels in people with an abnormal copy of a gene that causes sitosterolemia.~     People who carry only one copy of the abnormal gene are healthy but have increased blood~     levels of sitosterol. People with two abnormal copies of the gene have increased levels of~     sitosterol and have an increased risk of heart attack. This condition is called~     sitosterolemia. Although extremely rare in the general population, up to 4% of the Amish~     carry an abnormal copy of this gene.~      People of Amish background who are 18 years of age or older and in whom one person carries~     one copy of the abnormal gene that causes sitosterolemia and the other does not have an~     abnormal gene may be eligible for this study. Subjects must be of the same sex and within 5~     years of age of each other.~      During two periods of one month each participants receive pills containing sitosterol and~     then a special diet and meal supplements to change the levels of sitosterol in the diet.~     During only one of the two study periods, subjects receive sitosterol supplements in the~     pills for one month and then for 10 days in the diet. At the end of each study period,~     subjects come to the NIH Clinical Center for one day for the following tests:~        -  Measurements of height, weight, blood pressure and heart rate.~        -  Adipose (fat) tissue biopsy. A small piece of fat from under the skin of the abdomen is~          removed to examine how sitosterol affects fat tissue and its ability to process sugar~          and fat.~        -  Indirect calorimetry. A plastic transparent hood is placed over the subject s head to~          collect the air that is breathed for about one-half hour to study how the body uses~          sugar to generate energy.~        -  Endothelial vascular function. An ultrasound picture of a blood vessel in the forearm is~          taken and a blood pressure cuff is inflated around the arm to measure the vessel s~          ability to stretch.~        -  Intravenous glucose tolerance test: A small plastic tube is placed in a vein in each~          arm. Then over one minute the subject receives glucose through one of the tubes. Twenty~          minutes later the subject is given a small amount of insulin through the same tube.~          Blood samples are drawn through the tube in the other arm at frequent intervals for 3~          hours. This test measures how sitosterol affects how the body processes sugar.~        -  DEXA scan. The subject lies on an x-ray table for 20 minutes during the scan, which~          measures total body fat.~   "
231131|NCT00531115|"~     The purpose of this study is to determine confirmed objective response rate to combination~     therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with~     cetuximab plus capecitabine as first line treatment in elderly patients with metastatic~     colorectal cancer~   "
231132|NCT00531102|"~     Currently, newborns receive 100% supplemental oxygen by free flow when they remain cyanotic~     despite demonstrating regular respiratory effort. Resuscitating infants with continuous~     positive airway pressure (CPAP) in room air may improve oxygen saturations more quickly than~     providing FFO2 because of its ability to establish functional residual capacity in the lungs.~     Our primary hypothesis is that in this blinded, randomized control trial, more infants (≥35~     weeks gestation) resuscitated with CPAP in room air will have an oxygen saturation ≥80% at~     five minutes of age compared to infants resuscitated with the 50% FFO2.~   "
231133|NCT00531089|"~     The general objective of this study is to assess the efficacy and safety of Rituximab in the~     management of patients with refractory or relapsed thrombotic thrombocytopenic~     purpura-hemolytic uremic syndrome (TTP-HUS). There have been several case reports and case~     series describing the use of Rituximab in patients with TTP-HUS; however its use has not been~     studied in a large trial. It is hypothesized that Rituximab may ameliorate the severity of~     certain cases of TTP-HUS by decreasing the number of activity of B-cells which may result in~     decreased production of the ADAMTS13 protease inhibitor. Patients with TTP-HUS not responding~     to standard therapy or patients with relapsed disease may have particular benefit. Treatments~     that decrease the frequency of relapse or shorten the time to remission of TTP-HUS will be of~     benefit by decreasing the need for blood product support.~   "
231134|NCT00531076|"~     In spite of the use of radiation combined with conventional chemotherapy, the long-term~     survival prognosis for most patients with locally advanced non-small cell lung cancer is~     disappointing. Much effort is currently focussed on exploring new molecular targeted agents~     that may improve upon survival. The addition of an agent that targets blood vessel formation~     in tumors, bevacizumab or Avastin, to conventional chemotherapy has been shown to improve~     survival in metastatic non-small cell lung cancer. Data from animal studies have shown that~     bevacizumab and related agents also increase tumor cure rates when administered both during~     and after radiotherapy. This suggests that combined bevacizumab and chemo-radiation may~     improve survival in local-advanced disease as well. Before such clinical studies can~     commence, the safety and normal tissue toxicity profile of bevacizumab with thoracic~     radiotherapy must first be established. In this study, escalating doses of bevacizumab will~     be administered during radiotherapy, followed by maintenance bevacizumab.~   "
231135|NCT00531063|"~     This extension study is designed to provide long-term safety and efficacy data beyond 12~     months up to Month 36.~   "
231136|NCT00531050|"~     This study investigated the effect of exercise and high-dose salbutamol on the maximum heart~     rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic~     doses of indacaterol, salmeterol and placebo.~   "
231137|NCT00531037|"~     Observational study to assess AV block incidence and their evolution according to paroxysmal~     atrial arrhythmia.~   "
231138|NCT00531024|"~     Choroidal neovascularisation (CNV) in age-related macular degeneration is one of the major~     causes of blindness in the western world. It is already known that the vascular endothelial~     growth factor (VEGF) plays a major role in the development of CNV. Photodynamic therapy~     (PDT), subretinal surgery, and intravitreal injection of VEGF- inhibitors are the common~     treatments. These methods are either very invasive or need to be repeated several times over~     long periods of time in order show some effect. Furthermore PDT can only be performed in eyes~     with pigment epithelium detachments (PED) of maximum 50% of the avascular zone, while~     intravitreal injections can lead to endophthalmitis and acute glaucoma. A systemic treatment,~     which would only need to be administered 3 times within 6 weeks would be a major effort in~     macular degeneration therapy.~   "
231139|NCT00531011|"~     The purpose of this two part study is the assessment of the performance of the XIENCE V®~     Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific~     setting of patients with Multi-Vessel Coronary Artery Disease (MVD).~   "
231140|NCT00530998|"~     This is an observational study of pain and outcomes from females undergoing transvaginal~     NOTES removal of their appendix or gallbladder. Female subjects who elect to have a~     transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study~     (through signature on the informed consent form) will be followed per standard of care, with~     additional follow-up for data collection including the following:~        -  Subjects will complete a 7 day pain/temperature log after surgery~        -  Subjects will complete a standardized sexual function questionnaire (Female Sexual~          Function Index) prior to surgery and 6 months after surgery~        -  Subjects will receive a phone call at 6 months and at 1 year after surgery to capture~          data related to safety, adverse events, hospitalizations and patient satisfaction~      Additional data related to pain and outcomes will be collected at baseline/screening and at~     follow-up as necessary.~   "
231152|NCT00530829|"~     Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as~     treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent~     future episodes. The use of zinc at home to treat diarrhea in an African setting, where~     malaria, HIV and malnutrition are common, has not been well-studied.~      Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will~     decrease the community prevalence of diarrhea more than zinc given only in the clinic Work~     planned. We propose to do a community-randomized intervention study of 10 days of dispersible~     zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5~     years of age living in a rural part of Bondo District. The comparison group will be children~     who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the~     prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be~     the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the~     prevalence of acute respiratory infection, and the effect of malaria infection on treatment~     with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children~     will be followed for 1 year.~      Significance of results. If this study shows zinc given at home to be effective, this might~     be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in~     children at the community level.~   "
231153|NCT00530816|"~     To evaluate the best overall response rate, safety and tolerability of carfilzomib in~     patients with relapsed or refractory multiple myeloma.~   "
231154|NCT00530803|"~     The objective of this study is to compare the efficacy of the Synera patch applied for 20~     minutes with the efficacy of EMLA Cream applied for 60 minutes in reducing pain associated~     with venipunctures in children.~   "
231155|NCT00530790|"~     This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in~     Restless Legs Syndrome patients.~   "
231156|NCT00530777|"~     In this study, we will determine whether treating pregnant and breastfeeding women~     co-infected with human immunodeficiency virus type 1 (HIV-1) and herpes simplex virus type 2~     (HSV-2) with daily valacyclovir will reduce HIV-1 levels in plasma, genital, and breast milk~     and will decrease the risk of mother-to-child HIV-1 transmission.~   "
231157|NCT00530764|"~     The purpose of this study is to determine the effective dose range and to demonstrate a~     non-effective dose range of Sativex in patients with advanced cancer, who experience~     inadequate pain relief even though they are on optimized chronic opioid therapy.~   "
231158|NCT00530751|"~     RATIONALE: Learning about the concerns that individuals may have about providing family~     medical history online for genetic risk assessment or research may help doctors plan future~     research.~      PURPOSE: This clinical trial is studying views on sharing family medical history in healthy~     women undergoing mammograms or breast evaluation.~   "
231159|NCT00530738|"~     It is the purpose of this trial to provide evidence for safety and efficacy of long term home~     parenteral nutrition with either Lipofundin MCT or Lipoplus in patients with proven~     insufficient enteral resorption.~   "
231160|NCT00530725|"~     Collapsed lungs are common injuries after traumatic injury that regularly cause needless~     deaths despite being treatable with chest tubes. Properly used these tubes can be~     life-saving. Unfortunately, improperly used they can cause pain, bleeding, and other fatal~     complications themselves. Over the last few decades with increased use of CT scanning it is~     apparent that many small collapsed lungs are not seen on chest X-rays, and there is little~     guidance for the treating Doctors as to how to treat these patients. There is almost no good~     data that tells us whether these smaller pneumothoraces require treatment with chest tubes or~     whether they can simply be closely watched. This proposal is to carry out a simple trial of~     randomly assigning patients who do not appear to have any symptoms or problems from their~     occult pneumothorax to either having a standard chest tube or to being watched. Our careful~     review of the medical literature indicates that the investigators cannot honestly tell~     patients and their families which treatment is best or required. Our audit of current~     practice also indicates that Doctors in Calgary and across Canada, regularly prescribe both~     treatments regularly but in a hap-hazard. The patients in this study will be very closely~     watched in the intensive care unit and if they develop any breathing problems and do not have~     a chest tube in, then one will be inserted. The main results that the investigators are~     trying to determine with this pilot study, though, is whether the investigators are able to~     detect appropriate patients, to recruit them into such a study, and whether the guidelines~     the investigators have created to manage these patients in this study will be acceptable to~     all the patient's care givers. This data will help us to design a future large multi-centre~     trial that will hopefully provide information as how best to manage this type of injured~     patient.~   "
231161|NCT00530712|"~     This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting~     using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of~     atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.~   "
231162|NCT00530699|"~     The purpose of this study is to assess safety and tolerability of multiple ascending doses of~     AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with~     relapsed acute myeloid leukaemia who are not considered to be suitable for standard~     chemotherapy.~   "
231163|NCT00530686|"~     The purpose of this study is to assess a novel approach to immunosuppression in allogenic~     pancreatic islet cell transplant recipients. In addition, the study aims to assess remote~     site islet processing with culture for pancreatic islet cell transplantation in human~     subjects.~   "
231164|NCT00530660|"~     The purpose of this Phase II follow-up study (to study 810501) is to assess the~     immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza~     vaccine administered 12 to 17 months after a two-dose regimen of different doses of an~     adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A~     data safety monitoring board will review the safety data after the booster vaccination. The~     H5N1 influenza antibody persistence 180 days after the booster vaccination will also be~     assessed.~   "
231165|NCT00530647|"~     The purposes of this study are to investigate the functional connectivity of motor network in~     patients of stroke and investigate the mechanism of brain plasticity for recovery after~     stroke.~   "
231166|NCT00530634|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) together with radiation~     therapy after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well surgery followed by gemcitabine, cisplatin,~     and radiation therapy works in treating patients with stage II or stage III non-small cell~     lung cancer.~   "
231167|NCT00530621|"~     The purpose of this study is to determine if the combination of enzastaurin and pemetrexed~     can extend survival time without progression of disease for patients who have advanced or~     metastatic non-small cell lung cancer.~   "
231169|NCT00530595|"~     Cardiovascular disease is a leading cause of mortality in patients on hemodialysis therapy~     (HD), accounting for 30 to 50% of all death. Although angiotensin receptor blockers (ARBs)~     are effective for patients with diabetes and chronic kidney disease in reducing or preventing~     cardiovascular diseases, there has been no decisive study that demonstrated treatment with~     ARBs is effective in patients on HD.~   "
231170|NCT00530582|"~     Sleep is impaired in postmenopausal women (difficulty falling asleep, frequent awakenings).~     Progesterone prompted benzodiazepine-like effects on sleep EEG in young normal male subjects.~      Aim of this study was to test if replacement therapy with progesterone improves sleep after~     menopause.~      Design, Setting, and Participants: A double blind cross-over design study with 2 treatment~     intervals of 21 days duration separated by a 2 weeks washout was performed. A oral dose of~     300mg micronized progesterone was given each for 21 days. At the beginning and the end of the~     two intervals a sleep EEG was recorded and cognitive performance was assessed in 10 healthy~     postmenopausal women (age: 54-70 yrs).~   "
231171|NCT00530569|"~     About 30% of breast cancers have higher than normal levels of a cellular marker called HER2.~     The amount of HER2 is often measured in breast tissue. A higher level of this marker usually~     indicates a more aggressive type of breast cancer. Cytokeratin is a second cellular marker~     found in breast cancer cells. Detection of Circulating cytokeratin in the blood could~     indicate the presence of cancer. The Pathology Department of the Tom Baker Cancer Center is~     doing this study to see if measuring the levels of circulating HER2 and cytokeratin, through~     blood testing has clinical significance for patients with breast cancer.~   "
231172|NCT00530556|"~     To assess the efficacy and safety of zolpidem at doses up to 10 mg compared to placebo in~     patients with insomnia associated with osteoarthritis~   "
231173|NCT00530543|"~     The purpose of this study is to investigate the effects of robot-assisted gait training on~     active walking in the patients with stroke.~   "
231174|NCT00530530|"~     To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with~     restless legs syndrome~   "
231175|NCT00530517|"~     Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled~     with 6mg Sumatriptan to be used by patients to treat acute migraine treatment. Study~     participation will last one month and include 2 doctor visits and 2-4 phone calls.~   "
231176|NCT00530504|"~     The purposes of this study are:~        1. To provide additional safety and effectiveness information on the commercial use of~          Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection~          Device.~        2. To evaluate rare and unanticipated adverse events.~        3. To evaluate the physician level of experience with carotid artery stenting procedures~          with adverse event rates.~   "
231177|NCT00530491|"~     A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative,~     early removal of chest tubes) is evaluated compared to conventional perioperative treatment~     (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 <~     70% of expected value or < 1.5L who undergo resections of the lung.~   "
231178|NCT00530478|"~     The purpose of this study is to demonstrate the efficacy and safety of donepezil on the~     recovery of cognitive function in patients with stroke and to delineate the neurophysiologic~     mechanisms of the therapeutic effect of donepezil on the recovery of cognitive network using~     functional neuroimaging technique.~   "
231179|NCT00530452|"~     The primary objective of this study is to evaluate the safety and efficacy of 3 loading and~     maintenance dose levels of CG100649 administered for 21 days in the treatment of~     osteoarthritis pain.~   "
231180|NCT00530439|"~     Obesity is a serious and increasing health problem in the Western World with about one third~     of all pregnant women in Denmark being overweight. Among these are more than 11% severe~     obese.~      Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and~     mortality. Observational studies indicate that the rate of pregnancy complications among~     obese pregnant women can be limited if weight gain during pregnancy is restricted.~      Aims of the trial is to study the effects of diet and physical training during pregnancy~     among Danish obese women. Also to describe the metabolic effects of lifestyle intervention~     during pregnancy.~      360 obese pregnant women with Body Mass Index (BMI) > 30 are randomized to lifestyle~     intervention group or control group. The intervention is composed of individual dietician~     counselling and physical training. The physical training includes weekly aerobic exercises in~     a fitness center and lifestyle coaching in small groups.~      Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus,~     blood pressure, and metabolic markers. All women receive vitamin supplementation to assure~     sufficient intake.~   "
231181|NCT00530426|"~     The purpose of this registry is to compile a large clinical database on the medical~     management of patients hospitalized with acute heart failure, using information collected~     from acute care hospitals across the United States.~   "
231182|NCT00530413|"~     The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the~     treatment of catamenial epilepsy.~      We propose that since the catamenial seizures are associated with the reduction in levels of~     GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent~     Phenobarbital will reduce the incidence of catamenial seizures.~   "
231183|NCT00530400|"~     The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime~     is effective in preventing surgical site infection in patients undergoing surgery for~     herniated disk~   "
231184|NCT00530387|"~     It is known that people can develop an allergic skin reaction to a substance which is placed~     on the skin and then subjected to sunlight. This process is called Photocontact allergic~     dermatitis. It is known that people can develop Photocontact allergic dermatitis to sunscreen~     chemicals (filters) and also cream forms of pain-killing drugs called nonsteroidal~     anti-inflammatory drugs (NSAIDs).~      The purpose of this study is to determine the frequency of Photocontact allergic dermatitis~     to 19 sunscreen filters and 5 topical NSAIDs in 1,000 European patients who present to a~     dermatologist with a sun-exposed site dermatitis.~      Each participant will have the 24 test agents plus one control of petrolatum applied to the~     skin of the back for 24 or 48 hours. After removal of the substances, the area of skin will~     be exposed to a precise amount of ultraviolet-A light. The area is then assessed 24, 48 and~     72 hours later to see if a photocontact allergic reaction has occured. This method is known~     as photopatch testing.~      The study will run for one year, during which time it is planned to recruit 1,000 patients.~   "
231186|NCT00530361|"~     The purpose of this study is to assess whether nesiritide compared to placebo when given with~     standard of care therapies, helps preserve kidney function in heart failure (HF) patients~     undergoing heart bypass graft surgery that requires the use of a cardiopulmonary bypass~     machine (CPB pump or heart-lung machine).~   "
231187|NCT00530348|"~     The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™)~     as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with~     subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had~     not previously received MS disease-modifying therapies. Participants had monthly laboratory~     tests and comprehensive testing every 3 months.~   "
231188|NCT00530335|"~     The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120~     mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental~     Disorders, Fourth Edition (DSM-IV) criteria for ADHD~   "
231189|NCT00530322|"~     To ascertain whether there are fewer adhesions (internal scars) formed following laparoscopic~     (key-hole) surgery for colorectal diseases than traditional open surgery.~   "
231190|NCT00530309|"~     A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of~     GSK716155 in Japanese subjects with type 2 diabetes mellitus~   "
231191|NCT00530296|"~     The purpose of this study is to determine whether Cognitive Behavioral Therapy is effective~     in the treatment of depression in patients with end-stage renal disease in hemodialysis~     therapy~   "
231192|NCT00530283|"~     Patients with squamous cell cancer of neck nodes but unknown primary will have a PET-CT scan~     prior to biopsies. The utility of PET-CT will be determined in this subset of patients.~   "
231193|NCT00530270|"~     People with sickle cell disease (SCD) may develop acute chest syndrome (ACS), which is a~     common and serious lung condition that usually requires hospitalization. Dexamethasone is a~     medication that may decrease hospitalization time for people with ACS, but it may also bring~     about new sickle cell pain. This study will evaluate the effectiveness of a dexamethasone~     regimen that includes a gradual dose reduction at decreasing hospitalization and recovery~     time in people with SCD and ACS.~   "
231194|NCT00530257|"~     This study investigates whether OROS-methylphenidate improves performance on different~     aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder~     (ADHD).~   "
231195|NCT00530244|"~     The hypothesis of this study is that feeding infants diagnosed with CF via newborn screening~     a formula enhanced with a specific fish-oil fatty acid known as DHA will improve growth and~     decrease pancreatic dysfunction (as measured by human fecal elastase-1 in stool) over the~     first year of life.~      Briefly, infants diagnosed with CF in the first month of life whose parents chose not to~     breast feed their babies will be invited to enroll in a study comparing a standard commercial~     infant formula (Enfamil) with a formula enriched with arachidonic acid (AA) and~     docosahexaenoic acid (DHA). The study formula has 3 times the amount of DHA available in~     commercially available formulas. Infants will have monthly tests of stool elastase and blood~     work at entry, 3, 6, 9 and 12 months of age.~   "
231196|NCT00530231|"~     The purpose of this study is to determine the missing rate of capsule endoscopy using~     back-to-back capsule endoscopy.~   "
231197|NCT00530218|"~     RATIONALE: Antiviral drugs, such as ganciclovir, act against viruses. Giving ganciclovir by~     infusion and then by mouth may be effective treatment for cytomegalovirus that has become~     active after donor bone marrow transplant.~      PURPOSE: This phase II trial is studying how well giving ganciclovir by infusion and by mouth~     works in treating patients with cytomegalovirus after donor bone marrow transplant.~   "
231198|NCT00530205|"~     RATIONALE: Learning about the effects of radiation therapy on the body's muscles, organs, and~     bones in patients with stage III non-small cell lung cancer may help doctors plan the best~     treatment.~      PURPOSE: This clinical trial is studying the effects of radiation therapy on the body in~     patients with stage III non-small cell lung cancer.~   "
231199|NCT00530192|"~     This is an open-label, multicenter pilot study in patients with advanced solid tumors.~      The primary objective of this study is to compare progression-free survival using a treatment~     regimen selected by molecular profiling with progression-free survival for the most recent~     regimen the patient has progressed on.~      To be eligible, patients must have received at least two lines of prior chemotherapeutic,~     hormonal or biological regimens for advanced disease, have measurable or evaluable,~     refractory disease and have clear documentation of the time between treatment start and~     documented progression on the last treatment prior to study entry. Eligible patients must~     undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH~     and/or DNA microarray analysis.~   "
231200|NCT00530179|"~     The purpose of this study is to evaluate:~        1. whether an imaging test called a PET (Positron emission tomography) scan performed after~          two cycles of standard chemotherapy is able to identify patients who have a high cure~          rate after completing standard chemotherapy alone; and~        2. whether high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT)~          when used in combination with an antibody called Rituximab results in high cure rates~          for those patients predicted to do poorly with standard chemotherapy by the PET scan.~   "
231201|NCT00530166|"~     The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the~     percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks~     of therapy in patients with persistent asthma.~   "
231202|NCT00530153|"~     The purpose of this study is to evaluate the effects of an intervention programme on dietary~     intake and dental health of 8th grade students.~   "
231203|NCT00530140|"~     Poor prognosis follicular lymphoma patients have an estimated median overall survival of 5-6~     years. The proposed trial offers life-time idiotypic vaccination to all such patients in~     first relapse/progression who will achieve second (first, in the case of patients who have~     never achieved complete response following standard first-line treatment) complete response~     through autologous stem cell transplant prior to vaccination start. The ultimate goal is a~     cure, defined as a vaccine-maintained complete response lasting both at least 10 years and at~     least twice as long as each patient's first complete response.~   "
231268|NCT00529282|"~     The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a~     comparator in patients with fever and neutropenia~   "
231204|NCT00530127|"~     The primary objective of this study is to demonstrate the safety and tolerability of~     deferiprone in subjects with Friedreich's ataxia (FRDA).~      The secondary objective is to evaluate the efficacy of deferiprone for the treatment of FRDA,~     as assessed by a 9-Hole Peg Test (9HPT), Timed 25-Foot Walk (T25FW), Low-Contrast Letter~     Acuity test (LCLA), International Cooperative Ataxia Rating Scale (ICARS), and Friedreich's~     Ataxia Rating Scale (FARS).~      The tertiary objectives are to evaluate the effect of deferiprone on:~        1. cardiac function as measured by changes in Left Ventricular Shortening Fraction (LVSF),~          Left Ventricular Ejection Fraction (LVEF) and Left Ventricular (LV) mass using~          echocardiogram (ECHO),~        2. quality of life using quality-of-life surveys, and~        3. functional status using Activities of Daily Living (ADL).~   "
231205|NCT00530114|"~     The primary objectives of this study are the following:~        1. To demonstrate that AMG 223 will produce a statistically significant reduction in serum~          phosphorus compared with placebo over a 3 week treatment period in subjects with CKD~          receiving dialysis~        2. To describe a dose response for AMG 223~        3. To evaluate the safety and tolerability of AMG 223~   "
231206|NCT00530101|"~     The purpose of this research study is to evaluate MR imaging in subjects receiving~     doxorubicin chemotherapy to see if MR can detect heart damage as well as or better than MUGA~     scans.~      This research study is expected to enroll approximately 10 subjects over 12 months at the~     University of Miami / Miller School of Medicine.~   "
231207|NCT00530088|"~     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a~     certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy~     using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the~     mouth and throat.~      PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium~     works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer~     of the mouth or throat, or stage I cancer of the mouth or throat.~   "
231208|NCT00530075|"~     Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and~     necrotizing inflammation predominantly affecting the respiratory tract and the kidneys.~     Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is~     limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible~     damage due to the disease and the consequences of prolonged drug exposure. The efficacy and~     safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with~     refractory disease. A prospective, international, nulti-centre, single limb, open label~     study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity~     Score (BVAS) >=4 and previous therapy with cyclophosphamide or methotrexate.~     Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to~     clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in~     six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped~     early for white blood count < 4,000/mm3. The primary endpoint was complete remission (BVAS=0~     for at least 2 months) or partial remission (BVAS<50% of entry score). After the sixth cycle~     azathioprine was commenced and follow-up continued for a further six months.~   "
231209|NCT00530062|"~     This is a research study designed to compare the single-dose effectiveness of~     albuterol-HFA-BAI (breath activated inhaler) and albuterol-HFA-MDI (metered dose inhaler) in~     asthmatics with poor inhaler coordinating abilities. Patients must be 7 to 70 years of age to~     participate in this study.~   "
231210|NCT00530049|"~     RATIONALE: Developing a questionnaire that patients can use to assess their quality of life~     related to the appearance of their face after surgery may help doctors plan the best~     treatment for patients undergoing surgery and reconstruction for head and neck cancer in the~     future.~      PURPOSE: This clinical trial is developing a questionnaire for assessing quality of life~     related to facial appearance in patients who have undergone or are planning to undergo~     surgery and reconstruction for head and neck cancer; and after dermatologic surgery for~     patients with cutaneous skin cancers.~   "
231211|NCT00530036|"~     Urinary incontinence (UI) is a frequent problem in community-dwelling older adults and has a~     huge burden on health complications and healthcare costs. Although effective treatments~     exist, UI is frequently neglected resulting in unmet needs for continence treatment and~     potential negative health outcomes. The impact of UI in older patients receiving home care~     services has not been extensively explored. In a recent study we observed that UI was~     identified in 46% of 699 patients followed by the Fondation des Services d'Aide et de Soins~     à Domicile in Geneva but the impact of UI on outcome such as institutionalization,~     hospitalization or death is unknown.~   "
231212|NCT00530023|"~     Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus~     subjects continuing to administer insulin in multiple dose injections. Evaluate the~     educational materials and time required for training subjects naïve to continuous~     subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation~     for a large multi-center clinical trial~   "
231213|NCT00530010|"~     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near~     a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be~     effective treatment for liver cancer that cannot be removed by surgery.~      PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating~     patients with liver cancer that cannot be removed by surgery.~   "
231214|NCT00529997|"~     The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and~     effective as the control therapy of fusion in patients receiving decompression surgery for~     the treatment of clinically symptomatic spinal stenosis at one contiguous vertebral levels~     from L1-S1. Safety and effectiveness will be assessed by means of primary study endpoints~     which address improvements in pain and function in the absence of major device related~     complications.~      The study hypothesis criteria for demonstrating safety and efficacy requires scientific~     evidence that patients classified as satisfying the primary study endpoint post device~     implantation is at least as good for Stabilimax NZ® recipients as that for patients~     undergoing fusion with posterior pedicle screw instrumentation at the 24 month followup~     assessment.~   "
231215|NCT00529984|"~     STUDY OBJECTIVES~        1. The primary objective of this protocol is to determine the safety of immunization with~          CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies.~        2. The secondary objectives are to evaluate CEA-specific immune response to the~          immunizations and obtain preliminary data on response rate.~   "
231216|NCT00529971|"~     This study will examine the effectiveness of Mindfulness-Based Stress Reduction (MBSR) in~     helping men living with HIV cope with negative emotions and stresses in their life. MBSR is~     an approach to reducing stress for patients with chronic medical conditions. It involves~     systematic training in mindfulness meditation practices to increase quality of life and to~     reduce general stress, anxiety, depression or pain. The effectiveness of MBSR will be~     evaluated by looking at changes in participants' experience of stress, anxiety associated~     with pain management and psychosocial functioning before and after they receive the MBSR~     compared with participants who do not receive the MBSR treatment.~      In order to participate, individuals must be: male, living with HIV, age 18-70 years, live~     within one hour of participating centre, and have a good understanding of the English~     language. Questionnaires will be completed before individuals begin the program, at the end~     of the intensive phase (8 weeks) and at 6 months after the start of the group program. The~     primary program evaluation outcome will be a reduction in stress; secondary evaluation~     outcomes will include the improvements in the physical and emotional experience of pain as~     well as general psychosocial functioning and self-esteem.~   "
231217|NCT00529958|"~     The purpose of this randomized clinical trial is to determine the difference in quality of~     life outcome at two years, in patients undergoing an Anterior Cruciate Ligament (ACL)~     reconstruction procedure with either a patellar tendon, quadruple hamstring tendon or a~     double-bundle hamstring tendon autograft.~   "
231218|NCT00529945|"~     The primary object of this study is to demonstrate the continued safety and performance of~     the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic~     stroke, transient ischemic attack, migraine or decompression illness.~   "
231219|NCT00529932|"~     An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial~     with central core lab analyses to determine the safety of intra-coronary infusion of enriched~     CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute~     percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial~     infarction (STEMI).~   "
231220|NCT00529919|"~     The primary aim of this research project is to determine whether the incorporation of food~     products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a~     different degree of weight-loss and total and regional fat mass loss than the incorporation~     of extra light olive oil. The secondary goals are to test whether there are differences in in~     metabolic risk profile changes between the 2 diets. We hypothesize that men and women who~     consumed MCT oil as part of their weight loss program will lose more weight and body fat than~     those who consume olive oil in their weight loss diet.~   "
231221|NCT00529906|"~     The ultimate goals of this study are to identify patterns of familial aggregation with~     regards to categorical and dimensional approaches of ADHD and neuropsychological measures, to~     validate the phenotypes and endophenotypes that are close to biological expression of genders~     underlying ADHD, and to identify the genetic variants close to the etiological genes of ADHD~     in Taiwanese sample. We propose to replicate the analysis of the candidate genes identified~     by previous genetic studies on ADHD using the candidate gene association study design~     (family-based case control study using parental controls) to validate the findings from other~     research groups. With the accomplishment of these goals, this study will resolve~     controversies over inconsistent findings in previous genetic studies and contribute to the~     literature on the validity of ASD using clinical and genetic data.~   "
231222|NCT00529893|"~     The purpose of this study is examine the efficacy of atomoxetine on executive functioning~     measures including the Continuous Performance Test (CPT) and the executive function measures~     of the Cambridge Automated Neuropsychological Test Automated Battery (CANTAB).~   "
231223|NCT00529880|"~     -  To determine the feasibility of fludarabine and cytarabine as continuous infusion plus~          granulocyte-colony stimulating factor priming for elderly patients with resistant acute~          myeloid leukemia other than acute promyelocytic leukemia~        -  The feasibility will be evaluated in terms of toxicities, complete remission rate,~          duration of complete remission, disease-free survival, and overall survival.~   "
231224|NCT00529867|"~     The purpose of this study is to compare the safety and efficacy in children aged 6 - 59~     months with uncomplicated malaria, treated with either conventional artemether/lumefantrine~     tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya~   "
231225|NCT00529854|"~     Accurate documentation in the patient medical record is critical to ensure proper diagnosis~     coding and subsequent hospital reimbursement. Multiple studies have demonstrated that~     clinicians often omit diagnoses which may result in insurance company denials and significant~     delays in payment. In addition, omitting diagnoses decreases the severity of patient illness~     which is often used as a risk adjustment tool to compare institution and physician outcomes.~     Medical informatics has been used to help improve accurate diagnosis documentation as well as~     improve billing efficiency. We plan to utilize a medical informatics program called SIC-IR~     (Surgical Intensive Care - Infection Registry) to improve documentation and attending billing~     efficiency within the surgical and trauma intensive care unit (STICU). We propose a six month~     study: a three month observational evaluation of current billing procedures followed by a~     three month prospective evaluation using a newly created SIC-IR billing module. The outcome~     measures will include the number of ICD-9 and CPT codes at discharge per patient, severity of~     patient illness based on documentation, STICU charges, number of insurance company denials,~     DRG relative weights, as well as a qualitative assessment of attending physician use of the~     electronic billing module. The observational and prospective patient populations will be~     compared for total patient-days in the STICU, ventilator-days, antibiotic-days, infectious~     complications per patient, and injury severity score (trauma patients only) to ensure the~     populations are similar and only the documentation and billing changes can account for our~     measured outcomes. We hypothesize that the SIC-IR billing module will increase the number of~     patient ICD-9 and CPT codes at discharge, increase severity of STICU patient illness via~     accurate documentation, increase total STICU charges, decrease insurance company denials, and~     be an efficient and well accepted electronic medical application.~   "
231226|NCT00529841|"~     The purpose of this study is to develop a more physiological approach to the management of~     children and adolescents with salt wasting Congenital Adrenal Hyperplasia.~      We will administer the glucocorticosteroid via insulin infusion pump to see whether this~     treatment will improve the serum hormone concentrations.~   "
231227|NCT00529828|"~     The knowledge of the health effects of CLA on the human body is limited. However, CLA~     supplements are sold over the counter in several countries and various techniques are used to~     increase the content of CLA in food.~      The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins,~     inflammatory markers, blood pressure and insulin status in human volunteers relative to~     industrial trans fatty acids and to oleic acid.~   "
231269|NCT00529269|"~     This study will evaluate the impact that GI complaints have on patient-reported outcomes and~     to determine if there is improvement in patient-reported outcomes when converted from~     mycophenolate mofetil (MMF) to Enteric-coated mycophenolate sodium (EC-MPS)~   "
231228|NCT00529815|"~     The purpose of this pilot study is to determine if a Real-Time Continuous Glucose Monitoring~     System (CGMS) is a more effective method of improving glycemic control in patients with type~     2 diabetes than is episodic self blood glucose monitoring(SBGM) in the both the short- and~     long-term. CGMS, which includes a sensor that can be self- inserted under the skin and a~     discrete monitor that records and displays blood sugar levels nearly continuously, allows for~     real time blood glucose monitoring. This will be a prospective, randomized control trial~     comparing participants with type II diabetes use of CGMS versus SBGM. The primary endpoint~     will be improvement of glycemic control as measured by glycosylated hemoglobin (A1C). The~     secondary endpoints will compare mean daily glucose levels, the number of both hypoglycemic~     and hyperglycemic events, the amount of time spent in target blood glucose, and the perceived~     level of diabetes-related stress between the two groups. Participants will be randomized to~     either the control (SBGM) or intervention (CGMS) group. Subjects in the intervention group~     will alternate the use of the CGMS with episodic self blood glucose monitoring for four~     cycles of two weeks during the 12 week study. The control group will perform episodic SBGM~     throughout the study. The intensified monitoring schedules for both groups will end at the~     end of week 12, but glycemic control measurement by A1C will continue through 52 weeks. A1C~     levels will be drawn at 0, 12, 24, 38, and 52 weeks. Mean daily blood glucose levels, number~     of hypo and hyperglycemic events, and duration of time spent in target blood glucose range~     will be downloaded from patients' meters periodically throughout the study. The SF-8, a~     general quality of life questionnaire for people with chronic disease, and Problem Areas in~     Diabetes (PAID), a diabetes-related quality of life questionnaire, will be completed at the~     beginning and end of the study. The results of this study may help highlight which blood~     glucose monitoring methods are most likely to improve patients' ability to achieve and~     maintain target levels of glycemic control.~   "
231229|NCT00529802|"~     The purpose of this study is to learn if PET scanning can predict the degree of tumor~     shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.~   "
231230|NCT00529789|"~     The primary purpose of your participation in this study is to help answer the following~     research question, and not to provide you treatment for your condition. Whether duloxetine~     once daily orally is tolerated and safe, in children (aged 7 through 11 years) and~     adolescents (aged 12 through 17 years) with Major Depressive Disorder.~   "
231231|NCT00529776|"~     Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented~     by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds.~      Patients are randomized to CLRT or supine position if mechanically ventilated and not~     suffering from pneumonia or ARDS within 48 hours after intubation. Prophylaxis of VAP is~     standardized in both groups. Primary endpoint is incidence of VAP, secondary endpoints are~     length of ventilation, length of stay and mortality.~   "
231232|NCT00529763|"~     The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate~     to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR)~     rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib,~     or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP~     CML and Ph+ALL).~   "
231233|NCT00529750|"~     Primary:~        -  To evaluate the impact of irbesartan on endothelial function in hypertensive patients~          with metabolic syndrome.~      Secondary:~        -  To evaluate the oxidative stress status in patients with hypertension with metabolic~          syndrome.~        -  To correlate the oxidative stress status with endothelial function in these patients.~        -  To evaluate the effect of irbesartan on the oxidative stress stage in patients with~          metabolic syndrome and to correlate it with the effect on endothelial function .~        -  To correlate the change in endothelial function and oxidative stress stage with the~          change of arterial pressure levels.~   "
231234|NCT00529737|"~     Primary Objective:~      - To perform a prospective study to determine if there is a different in the marker clip~     migration if the first post-biopsy mammogram was performed in the same projection as the core~     biopsy versus in the orthogonal projection.~   "
231235|NCT00529724|"~     Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in~     patients with motor complications. However, the post-operative body weight gain involved may~     limit the benefits of surgery and induce critical metabolic disorder. The aim of this study~     to determine the energy expenditure in usual conditions of life.~   "
231236|NCT00529711|"~     Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG~     subjects have shown an increase in several cardiac performance parameters, with lesser volume~     of resuscitation fluid required to reach circulation volume, as compared to Sodium~     Chloride.It also does not cause hyperchloremic acidosis, which is of value in treating shock~     patients.~      The primary objectives of this prospective, randomized, open-label trial are to evaluate the~     clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain~     hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and~     body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence~     of adverse events.The secondary objectives are to evaluate comparative clinical efficacy of~     the two fluids in relation to reduction in concomitant drug utilization, duration of~     ventilator usage, length of stay in ICU as well as total duration of hospitalization and~     neurocognitive status upto a period of 1 year post-CABG.~   "
231237|NCT00529698|"~     This Phase I study is directed at evaluating the safety profile (as a primary end-point) and~     the immunogenicity (as a secondary end-point) of the recombinant HIV-1 Tat vaccine in~     healthy, immunologically competent adult subjects without identifiable risk of HIV-1~     infection.~   "
231238|NCT00529672|"~     For more than 100 years, surgery has been the standard of care of varicose veins of the legs.~     The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively~     high recurrence rate in the long term (up to 40%). In the last decade, several new techniques~     have become available but they have not yet been compared to surgery. This trail will~     evaluate the effectiveness, patients` perspective and cost effectiveness of surgery and~     non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous~     laser therapy.~   "
231239|NCT00529659|"~     A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with~     sarcopenia (loss of muscle mass).~   "
231240|NCT00529646|"~     The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791~     when administered as a single oral dose to healthy adult subjects.~   "
231270|NCT00529256|"~     The Department of Family Practice at Michigan State University partnered with BCBSM with a~     grant from the Robert Wood Johnson Foundation to recruit primary care practices for a 3 year~     study designed to assess smoking cessation referral rates by primary care physicians in~     Michigan.~   "
231290|NCT00528996|"~     The primary objective of this study is to compare the bronchodilator efficacy of three doses~     (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and~     tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives~     include comparing the effects on dyspnea and health status.~   "
231241|NCT00529633|"~     Both malnutrition and inflammation are associated with death in dialysis patients and also~     with cardiovascular disease. The researchers are testing the idea that inflammation causes~     malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out~     whether that will increase blood tests that are associated with malnutrition. The researchers~     will give hemodialysis patients who have both inflammation and malnutrition either~     thalidomide or a placebo and compare the effects of treatment on the levels of two proteins~     in the blood, albumin and prealbumin, that are normally reduced in malnourished patients.~     Patients who have a serum albumin concentration < 3.8 g/dl will be asked to sign consent to~     have blood drawn prior to dialysis for measurement of CRP (C-reactive protein). Those with~     CRP values ≥ 0.8 mg/dl will have a second measurement of CRP performed within 2 weeks. Those~     with two consecutive values of CRP ≥ 0.8 mg/dl will be eligible for enrollment~   "
231242|NCT00529620|"~     The purpose of this trial is to compare the acceptability, efficacy and safety of three~     alternative drug regimens for use for seasonal Intermittent Preventive Treatment to prevent~     malaria in children. Children aged 2 months to 5 years will be randomized to receive IPT with~     one of three regimens during the transmission season: sulfadoxine-pyrimethamine (SP) plus~     amodiaquine, show to be highly effective for IPT in a recent trial; SP plus piperaquine, used~     for malaria prophylaxis in China for many years; or Duocotexcin (a combination of piperaquine~     with an artemisinin).~   "
231243|NCT00529607|"~     The primary purpose of this study is to correlate new cardiac imaging modalities (2D, 3D~     echocardiography, contrast echocardiography, strain analysis and cardiac MRI) to biochemical~     parameters as the L-arginine-nitric oxide pathway and inflammatory cascades to characterize~     the reperfusion injury following myocardial infarction and thus providing a basis for further~     diagnostic and therapeutic approaches.~   "
231244|NCT00529594|"~     The study wants to show if the medication etoricoxib 120 mg have reduces the patients pain~     during the laser photocoagulation, for diabetic retinopathy.~   "
231245|NCT00529581|"~     The purpose of this study is to determine the safety and efficacy of C105 in treating the~     cognitive deficits that can occur due to multiple sclerosis.~   "
231246|NCT00529568|"~     The purpose of this study is to assess the ability of eltrombopag to maintain a platelet~     count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy~     dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical~     benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve~     a Sustained Virological Response (SVR).~   "
231247|NCT00529555|"~     Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of~     the root surfaces of the teeth. This is also called scaling and root planing. Placing a~     topical antibiotic into the periodontal pocket at the time of scaling and root planing may~     help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl)~     2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now~     being tested in the US.~   "
231248|NCT00529542|"~     The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the~     treatment of PCOS with elevated LDL cholesterol.~   "
231249|NCT00529529|"~     This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg~     capsules) once daily [od]), compared with salmeterol (50 μg twice a day [b.i.d.]), over 26~     weeks, in patients with moderate to severe persistent asthma.~   "
231250|NCT00529516|"~     Since influenza vaccines are administered every year because of the frequent change in their~     antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza~     vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this~     observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will~     receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only~     subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for~     participation in this study.~   "
231251|NCT00529503|"~     This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus~     placebo in patients with DLBCL. The study will assess safety and tolerability and will~     measure any additional clinical benefit observed in patients receiving SGN-40.~   "
231252|NCT00529490|"~     Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic~     lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic~     stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible~     received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when~     fluid resuscitation was needed.~   "
231253|NCT00529477|"~     The objective of this study is to examine the functional effects of methacholine challenge on~     small airways using three different nebulizers to generate particles with HMAD suitable for~     distribution in small, intermediate and large airways.Pulmonary function will be assessed~     using plethysmography and impulse oscillation techniques. Eight asthmatic subjects (>18~     years, both sexes) who are stable clinically and require only intermittent ß2-agonist~     treatment will be recruited to undergo methacholine challenges for an in vivo, dose-finding~     observational study. Three separate methacholine challenges will be carried out using each of~     the three different nebulizers. After each challenge, pulmonary function tests will be~     performed on subjects to assess functional changes in large and small airways. Results of the~     tests will be compared between the three nebulizers. These experiments will demonstrate~     whether or not functional changes occur in small airways in response to methacholine, as~     measured by pulmonary function tests after selectively targeting small airways using the~     nebulizer which generates small particles. The results from these experiments will give us a~     better understanding of the role of small airways in methacholine-induced bronchoconstriction~     in asthmatics, and will compare sensitivity of plethysmography compared to forced oscillation~     for detecting changes in small airways.~   "
231288|NCT00529022|"~     The goal of this clinical research study is to find out if giving azacitidine with valproic~     acid plus carboplatin can help control advanced cancer. The safety of this treatment will be~     studied as well. Researchers will also collect some extra blood samples for molecular marker~     studies (studies that may help researchers predict how participants respond to the combined~     therapy).~      There were to be two phases of this study: a Phase 1 portion to find acceptable doses of the~     study drug combination, and a Phase 2 portion to study the response rates to the treatment~     schedule. The study did not proceed to the Phase 2 portion.~   "
231254|NCT00529464|"~     Primary objectives~        1. To conduct a randomized clinical trial of the emerging technology fluorescence and~          reflectance spectroscopy, comparing colposcopy to colposcopy + spectroscopy in the~          diagnostic setting, stratifying patients by outside Papanicolaou (Pap) smear of low~          grade and high grade squamous intraepithelial lesions, and to use multispectral digital~          colposcopy retrospectively.~           The number of clinically read referral Paps, clinically read UT MD Anderson Cancer~          Center (MDACC) Paps, quantitatively read Paps, quantitatively read biopsies, point probe~          fluorescence/reflectance spectroscopy, and the multi-spectral digital colposcopy image,~          that shows a possible cancer, High-grade Squamous Intraepithelial Lesion (HGSIL),~          Low-grade Squamous Intraepithelial Lesion (LGSIL), or changes less than LGSIL to~          colposcopically directed biopsies at the first visit, Loop Electrical Excision Procedure~          (LEEP) at the second visit if needed, repeat evaluations at 6, 12, and 18 months that~          have Paps, or Paps + Endocervical Curettage or sample of the cervical canal + possible~          biopsy, and at the 24 month visit when all patients will at minimum have a Pap and an~          Endocervical Curettage for certain, and a cervical biopsy if any colposcopic abnormality~          is present.~        2. To see if optical spectroscopy using both the point probe and the multi-spectral device~          improves diagnosis by improving specificity over colposcopy alone.~             1. To study the number of colposcopically directed biopsies that show High-grade~               Squamous Intraepithelial or cancer.~             2. To study the number of LEEP specimens that show HGSIL or cancer.~   "
231255|NCT00529451|"~     This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300~     mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.~   "
231256|NCT00529438|"~     This study assesses the tolerability, safety, efficacy and pharmacokinetics of Bardoxolone~     methyl (RTA 402) in advanced solid tumors and lymphoid malignancies.~   "
231257|NCT00529425|"~     Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral~     neck fractures. Systemic opioids have side effects that might obstruct mobilization and~     induce delirium and nausea. The investigators hypothesized that wound infiltration results in~     reduction in systemic opioid usage and pain relief without side effects.~   "
231258|NCT00529412|"~     To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in~     patients who underwent surgery for gastric cancer.~   "
231259|NCT00529399|"~     The purpose of this study is to determine whether treatment with multiple injections of~     GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have~     been recently diagnosed with type 1 diabetes mellitus (T1DM).~   "
231260|NCT00529386|"~     The objective of this study is to evaluate the safety and efficacy of intraprostatic~     injection of Botox for the treatment of men diagnosed with chronic nonbacterial~     prostatitis/chronic pelvic pain syndrome (CP/CPPS).~   "
231261|NCT00529373|"~     The purpose of the event-driven base study is to determine the safety and efficacy,~     especially fracture-risk reduction, of odanacatib in postmenopausal women diagnosed with~     osteoporosis. In a placebo-controlled extension of the base study, participants continue to~     receive the same blinded study medication for a total of up to 5 years of blinded study~     medication combined between the base study and the extension. After all participants receive~     at least 5 years of blinded study medication, they will be invited to enroll into a second~     extension study in which they will receive open-label odanacatib for an additional 5 years.~   "
231262|NCT00529360|"~     Hypothesis: Myeloablative conditioning using a dose escalation of clofarabine in combination~     with cytarabine (ARA-C) and total body irradiation (TBI) will lead to improved survival for~     previously untransplanted children and adolescents with acute lymphoblastic leukemia (ALL)~     and acute non-lymphoblastic leukemia (ANLL)followed by allogeneic stem cell transplantation~     (AlloSCT).~   "
231263|NCT00529347|"~     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA~     delivers assist to spontaneous breathing based on the detection of the electrical activity of~     the diaphragm. We study the effect of changing ventilatory parameters on the patient's~     breathing pattern during NAVA.~   "
231264|NCT00529334|"~     This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast~     Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase~     II study. It will evaluate quality of life (QOL) issues as they relate to treatment related~     side effects, cosmetic result, and patient convenience.~      Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or~     less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this~     protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and~     sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK).~     Subjects will receive CK before chemotherapy, if applicable.~   "
231265|NCT00529321|"~     The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040~     in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1).~      Patients will be sequentially treated at an escalting dose of TG4040. All patients will be~     followed up to at least 6 months after his/her first injection. In addition, all patients~     treated at the highest dose will receive a TG4040 boost injection 6 months after the first~     injection, and will be followed up during an additional 6-month period.~   "
231266|NCT00529308|"~     This study will evaluate the clinical efficacy of 1 Hz repetitive transcranial magnetic~     stimulation (rTMS) applied to the supplementary motor area (SMA) in Tourette's Syndrome (TS)~     patients who have not fully responded to conventional therapies. The investigators will~     collect TMS measures of motor cortex excitability to test whether rTMS restores normal levels~     of intracortical inhibition found to be deficient in TS. The investigators will administer~     neuropsychological tests to demonstrate that SMA targeted rTMS can be administered safely~     without significant impairments of cognitive or motor functioning. The investigators~     hypothesize that:~        1. Compared to sham (placebo), active rTMS will improve symptoms of TS as assessed with the~          Yale Global Tic Severity Scale (Y-GTSS) and Clinical Global Impression (CGI).~        2. Active (but not sham) rTMS will normalize levels of motor cortex excitability, as~          reflected by increased intracortical inhibition, motor threshold, and cortical silent~          period, and by decreased intracortical facilitation, relative to pre-treatment baseline.~   "
231267|NCT00529295|"~     The purpose of this study was to estimate the safety and efficacy of titrated oral~     misoprostol compared with vaginal route for labor induction at term.~   "
231271|NCT00529243|"~     The primary objective of this study is:~      To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human~     immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of~     serum human immunodeficiency virus(HIV) (< 75 copies/ml by branch deoxyribonucleic acid~     (bDNA) assay, < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their~     current HIV medication regimen.~      Hypothesis:~      HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA~     levels below limits of quantification can safely have the investigational integrase~     inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.~   "
231272|NCT00529230|"~     Primary Objective:~      1. To determine the prevalence of secondary hypogonadism in male patients on chronic opioid~     therapy for cancer-related pain syndromes.~      Secondary Objective:~      1. To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male~     patients on chronic opioid therapy for cancer-related pain syndromes.~   "
231273|NCT00529217|"~     The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic~     stimulation in the treatment of Depersonalization Disorder (DPD).~   "
231274|NCT00529204|"~     Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are common~     complications of type 2 diabetes and leading causes of liver disease in the US and Europe.~     The prevalence of NAFLD and NASH are expected to become a major cause of liver disease~     related deaths and liver transplantation. Currently, there are no specific therapies that~     alter the natural history of NAFLD.Preliminary evidence suggests that exenatide (Byetta®) may~     have several beneficial direct and indirect effects on NAFLD and liver lipid metabolism.~   "
231275|NCT00529191|"~     The goal of this application is to evaluate the safety and efficacy of atorvastatin as a~     potential treatment to preserve beta cell function in children and young adults with newly~     diagnosed type 1 diabetes (T1DM).~   "
231276|NCT00529178|"~     To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease,~     the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to~     placebo.~   "
231277|NCT00529165|"~     The purpose of the study is to demonstrate, that there is no difference in metabolic control~     in patients with type 2 diabetes mellitus and therapy with human insulin with or without~     injection-meal-interval.~   "
231278|NCT00529152|"~     -  The primary objective is to assess the safety of Ferriprox oral solution for the~          treatment of iron overload in pediatric patients with transfusion-dependent anemia.~        -  The secondary objective is to assess the efficacy of Ferriprox oral solution in reducing~          iron overload in pediatric patients with transfusion-dependent anemia.~   "
231279|NCT00529139|"~     Mortality rates of patients with acute kidney injury in the intensive care unit have changed~     little over the past few decades despite significant advances in supportive care. Few~     interventions have been shown to result in an improvement of in-hospital mortality of these~     patients, with dose of renal replacement therapy (RRT) being one of the most important.~     Patients undergoing continuous veno-venous hemofiltration had better outcomes with~     ultrafiltration rates of 35 mL/kg/h or 45 mL/kg/h than those treated at a rate of 20 mL/kg/h.~     In a different trial, intermittent hemodialysis on a daily basis resulted in better control~     of uremia, fewer hypotensive episodes during dialysis, and more rapid resolution of acute~     renal failure than thrice weekly hemodialysis. In the present study we examine survival and~     renal recovery in critically ill patients with acute kidney injury that are treated with a~     currently recommended (standard) dose of RRT, and patients that receive intensified RRT.~   "
231280|NCT00529126|"~     Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine~     HCl.~   "
231281|NCT00529113|"~     This study assesses the safety and efficacy of RTA 402 in combination with gemcitabine in~     patients with unresectable pancreatic cancer.~   "
231282|NCT00529100|"~     Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being~     treated with pemetrexed in combination with cisplatin and radiation.~   "
231283|NCT00529087|"~     The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of~     subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have~     Opioid-Induced Constipation (OIC).~   "
231284|NCT00529074|"~     We plan to demonstrate the superiority of epidural anaesthesia/analgesia in repairs of large~     ventral hernias as compared with a conventional narcotic analgesia regimen.~      We hypothesize that:~        1. Primary outcome measures will improve. Patients will have a shorter length of stay (1~          day less) with pre and post-operative epidural analgesia.~        2. Secondary outcome measures will also improve. Among them will be VAS pain scores, time~          to first flatus and bowel movement as well as major and minor complications.~   "
231285|NCT00529061|"~     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease~     that can cause intense pain episodes. The purpose of this study is to gather medical~     information from children and adults with SCD and establish a database so that researchers~     can contact people to participate in future SCD research studies.~   "
231286|NCT00529048|"~     Patients with T2DM lac a sufficient incretin response after oral glucose intake. It has only~     been tested using 50g of glucose. We don't know if patients with T2DM are capable of~     regulating the incretin effect like healthy people in responds to different amounts of~     glucose intake.~      The aim of the present study is to quantify the incretin effect in healthy subjects and in~     patients with T2DM during increasing amounts of oral glucose challenges. The proposed studies~     will answer important questions on the mechanisms underlying T2DM and be of importance in~     relation to future preventive- and treatment strategies.~   "
231287|NCT00529035|"~     The purpose of this research study is to determine the safety of IL-2 and the highest dose of~     this drug that can be given safely to people with chronic graft versus host disease (GVHD).~     Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem~     cell or cord blood transplant. The donor's immune system may recognize their body (the host)~     as foreign and attempt to reject it. Traditional standard therapy to treat chronic GVHD is~     prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to~     control chronic GVHD.~   "
231289|NCT00529009|"~     To assess the bile acid composition of cystic bile and serum pharmaco¬kinetics after a 3-week~     treatment with UDCA and to correlate pharmacokinetic parameters of UDCA in bile and serum~     during steady state.~   "
231291|NCT00528983|"~     The purpose of this study is to determine whether a tablet form of azacitidine that taken by~     mouth is safe. This Phase I study will also look at different doses and different treatment~     schedules in order to better understand the effects (positive and negative) of oral~     azacitidine on the body and on the disease MDS, AML and CMML.~   "
231292|NCT00528970|"~     To assess, in subjects who have ventral wall hernia repair, the time between the end of~     surgery and first bowel movement with the investigational MOA-728 regimen as compared with a~     placebo regimen.~   "
231293|NCT00528957|"~     The primary objective of this study is to assess the efficacy of switching to tenofovir~     disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining~     virologic suppression in HIV-1 infected children.~   "
231294|NCT00528944|"~     Although single breath helium (He) dilution measurement (VASB) is currently used in pulmonary~     function laboratories to assess functional alveolar volume and diffusing capacity for carbon~     monoxide, the extent to which VASB reflects ventilatory and thoracic volume has not been~     prospectively determined in emphysema. We hypothesized that VASB underestimates rebreathe~     helium dilution volume (VARB), and plethysmographic volume (VApleth) as clinical and~     physiologic severity of emphysema increases.~   "
231295|NCT00528931|"~     A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's~     contracture conducted at one site in the United States. All subjects received a single dose~     of AA4500 0.58 mg, which was injected directly into the cord affecting either the~     metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood~     samples were collected before dosing, at predetermined time points through the 24 hours after~     dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after~     the AA4500 0.58 injection.~      This study was designed to be part of the larger clinical program, for adult patients with~     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal~     Placebo-Controlled studies (AUX-CC-857 [NCT00528606]and AUX-CC-859 [NCT00533273]) and 7~     non-pivotal studies were evaluated.~   "
231296|NCT00528918|"~     The purpose of this study is to compare Apidra (a rapid acting insulin analogue) with Regular~     insulin (fast acting) in addition to the use of long acting insulin Glargine in hospitalized~     patients in terms of efficacy and safety in blood glucose control and frequency of low blood~     glucose. Blood glucose control along with incidence and rate of low blood glucose during the~     hospitalization shall be of primary interest; length of hospital stay comparing the short~     acting insulin used shall be the secondary interest.~   "
231297|NCT00528905|"~     The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with~     stable schizophrenia who are being treated with an atypical antipsychotic and who are active~     cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal~     dose(s) to be used in future trials.~   "
231298|NCT00528892|"~     The investigators hypothesis is that switching from a ritonavir-boosted PI to raltegravir may~     be associated with an at least non-inferior effectiveness, virological response and safety,~     and even a better tolerability profile with regard to lipid metabolism, insulin resistance,~     body fat distribution as compared with continuation of the baseline regimen in HIV-1~     seropositive males or females at least 18 years of age and older on ritonavir-boosted PI plus~     at least 2 other drugs and plasma viral RNA below 50 copies/mL.~   "
231299|NCT00528879|"~     The purpose of this clinical research study is to learn whether dapagliflozin can help reduce~     blood sugar levels in participants with Type 2 diabetes that is not well controlled on~     metformin alone. The safety of this treatment will also be studied.~   "
231300|NCT00528866|"~     RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can~     cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide,~     goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body.~     Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation~     therapy together with androgen suppression and docetaxel after surgery may kill any tumor~     cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving radiation therapy together with~     androgen suppression and docetaxel works in treating patients with high risk prostate cancer~     who have undergone radical prostatectomy.~   "
231301|NCT00528853|"~     A major source of graft failure and dysfunction in lung transplantation is known to be~     bronchiolitis obliterans (BO)and its clinical correlate called bronchiolitis obliterans~     syndrome(BOS). In fact, BOS is the leading cause of death in lung recipients beyond one year~     post transplant. Currently, our ability to assess lung injury after transplant is less than~     ideal.~      The purpose of this study is to use new computerized tomography(CT) technology, specifically~     , 64 bit acquisition, to detect and predict the onset of lung injuries, with the hope of~     finding better therapies that currently exist.~   "
231302|NCT00528840|"~     This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a~     diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal~     interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one~     finger, other than the thumb, that was at least 20° as measured by finger goniometry and was~     suitable for evaluation and injection were enrolled.~      This study was designed to be part of the larger clinical program, for adult patients with~     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal~     Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7~     non-pivotal studies were evaluated.~   "
231303|NCT00528827|"~     To define the relationship between Cardene I.V. dose, serum concentrations, and blood~     pressure reduction in pediatric subjects with hypertension.~   "
231304|NCT00528814|"~     Asthma is a common, serious illness among children in the United States. Improving hand~     cleanliness and hygiene may prevent the spread of viruses that can cause asthma~     exacerbations. This study will evaluate the effectiveness of a school-based hand sanitizer~     program at reducing the frequency of exacerbations in children with asthma.~   "
231317|NCT00528645|"~     AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. This phase II study is studying how well giving AZD0530 works in treating patients~     with extensive-stage small cell lung cancer.~   "
231305|NCT00528801|"~     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease~     that can cause intense pain episodes and may lead to organ failure. Preliminary studies have~     shown that adults with SCD may have brain abnormalities that contribute to problems with~     cognitive functioning, including attention and memory difficulties. This study will use brain~     magnetic resonance imaging (MRI) and neuropsychological testing to examine the differences in~     cognitive functioning in adults with SCD and adults without SCD.~      212 subjects participated in this cross-sectional study consisting of screening~     questionnaires, a neuropsychological testing battery, and MRI testing. Enrollment into this~     study ended in May 2008.~   "
231306|NCT00528788|"~     Patients with chronic kidney disease and end stage renal disease have greater cardiovascular~     risk than the general population. Vitamin D analogues have been shown in observational~     studies to have mortality benefit for these patients. This study is designed to investigate~     doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible~     mechanism to explain the mortality benefit.~   "
231307|NCT00528775|"~     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is~     exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may~     be an effective treatment for advanced non-small cell lung cancer that blocks the air~     passages.~      PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in~     treating patients with advanced non-small cell lung cancer that blocks the air passages.~   "
231308|NCT00528762|"~     Primary Objective:~      For focus groups of Mexican American and African-American girls and focus groups of their~     parents to explore factors that could enhance the conduct of a future study of puberty and~     body mass.~      Specifically these focus groups will address:~        -  Whether clinical assessment of pubertal staging is acceptable.~        -  How to enhance cooperation by parents and their daughters of different socioeconomic~          groups, among families with different levels of acculturation, and girls of different~          body mass indices.~        -  Explore whether established questionnaire items about puberty, that have been used in~          traditional surveys, require culture-specific changes to improve exposure assessment.~        -  Explore the acceptability of self-reported pictograms for body image and for~          developmental assessment by girls.~   "
231309|NCT00528749|"~     This study is intended to compare intrathoracic pressure and respiratory effort data obtained~     by forehead venous pressure and respiratory movement (FVP/RM) with data obtained by the~     current gold standard, esophageal manometry. If this feasibility study validates the ability~     of FVP/RM data to quantitatively measure respiratory effort non-invasively, further studies~     will be performed to validate the utility of the ARES device in diagnosis of the UARS.~   "
231310|NCT00528736|"~     The aim of the study was to evaluate BNP in preterm infants < 28 weeks on the second day of~     life, when it is still unknown, if a patent ductus arteriosus is hemodynamic significant or~     not. We hypothesized that high plasma BNP concentrations on day 2 are associated with the~     need of PDA intervention in the further course.~   "
231311|NCT00528723|"~     The purpose of this trial is to verify if the test treatment BDP 250 mcg/salbutamol 100 mcg~     HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed~     combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi~     Farmaceutici) in terms of Pulmonary Function (morning PEF).~   "
231312|NCT00528710|"~     Fundamentally, the trial aims to conduct a gold-standard test of the clinical impact of SAM-e~     in the treatment of depressed mood and general symptoms of fibromyalgia (FMS).~      As such, salient clinical and pathological parameters will be assessed over an 8-week period~     in 60 patients who will be provided with either SAM-e or a placebo preparation . On the basis~     of previous literature, it is hypothesised that patients in the active treatment group will~     experience moderate but significant improvements across the clinical measures, and that these~     gains will be significantly greater than any reported in the placebo group. All patients will~     provide informed consent. All procedures will be conducted under medical supervision and the~     preparation itself is very safe when used in the manner proposed for the trial~   "
231313|NCT00528697|"~     The purpose of this study is to test if the investigational medication ABT-089 is a safe and~     effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.~   "
231314|NCT00528684|"~     RATIONALE: Oncolytic viruses such as reovirus (REOLYSIN®) can specifically kill tumor cells~     while leaving healthy cells unharmed.~      PURPOSE: This phase I/II study investigates the maximum tolerated dose (MTD), dose limiting~     toxicity (DLT) and anti-tumor effect of intralesional administration of REOLYSIN® therapeutic~     reovirus in patients with malignant glioma with evaluable disease which is~     progressive/recurrent despite surgery and/or radiotherapy with or without chemotherapy. (The~     phase I portion of the study is currently enrolling patients.)~   "
231315|NCT00528671|"~     We aim to investiagte whether very low dose self management of oral anticoagulation is~     superior to low dose oral anticoagulation in order to prevent bleeding events in patients~     undergoing mechanuical heart valve replacement.~   "
231316|NCT00528658|"~     Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen~     are commonly used oral analgesics in emergency departments (ED) not only in Hong Kong but~     throughout the world. There are no large-scale (n>100), prospective, randomised studies~     comparing paracetamol with ibuprofen in the management of acute soft tissue injury.~      As paracetamol is cheaper than most NSAIDs, may be as effective in the management of acute~     pain and possibly with fewer adverse effects, a large-scale, randomised, controlled trial is~     needed to answer questions of relative analgesic efficacy, safety and cost-effectiveness.~     Previous comparative studies on NSAIDS have been done in this unit and have suggested~     equivalence between two NSAIDs and paracetamol, but numbers were small and drug doses were~     modest.~      Objective: To compare the efficacy, safety and cost between oral ibuprofen and paracetamol in~     pain control for acute soft tissue injuries in an ED setting~      Design: Prospective, double-blind, randomised controlled trial with three arms: oral~     paracetamol with placebo; oral ibuprofen with placebo; paracetamol and ibuprofen in~     combination~      Participants: 783 subjects having sustained isolated soft tissue limb injury without~     significant fracture presenting to the ED of Prince of Wales Hospital~      Main outcome measures: Pain relief profiles of paracetamol, ibuprofen and the combination of~     both; adverse effect profiles of paracetamol, ibuprofen and the combination of both; overall~     cost effectiveness of paracetamol, ibuprofen and the combination of both from the perspective~     of the healthcare provider~   "
231318|NCT00528632|"~     Cholesterolosis is a common finding in biopsy specimens of gallbladders surgically removed~     for cholelithiasis.~      To the best of the investigators knowledge no study has analyzed the relationships of Body~     Mass Index, serum Cholesterol and Triglycerides and gallbladder cholesterolosis.~      The purpose of this study is to analyze and find relations between gallbladder~     cholesterolosis, Body Mass Index, serum cholesterol and triglycerides.~   "
231319|NCT00528619|"~     This study will assess the maximum tolerated dose, overall safety and antitumor activity of~     SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and~     carboplatin in patients with advanced solid tumors.~   "
231320|NCT00528606|"~     This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the~     United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal~     (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at~     least one finger, other than the thumb, that was at least 20° as measured by finger~     goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or~     placebo.~      This study was designed to be part of the larger clinical program, for adult patients with~     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal~     Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7~     non-pivotal studies were evaluated.~   "
231321|NCT00528593|"~     The purpose of this study is to evaluate the effect of epoetin alfa on HIV-associated~     neuropathy by measuring changes in nerve fiber density and pain ratings.~   "
231322|NCT00528580|"~     We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis~     that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and~     clinical outcomes in adults hospitalized with sepsis. As our animal models suggest~     pretreatment with statins are required for their beneficial effects, we propose a study~     design intended to identify patients and initiate treatment early in their hospital stay.~     This Phase II study is intended to assess the feasibility of conducting a large-scale~     investigator-initiated translational research protocol that involves multiple clinical~     services within the Department of Medicine.~   "
231323|NCT00528567|"~     The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of~     patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy~     with 1 year of bevacizumab.~      The secondary objectives of this trial are to:~        -  compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free~          Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to~          treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination~          with 1 year of bevacizumab~        -  evaluate the safety and tolerability of bevacizumab~      An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or~     serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab~     to standard adjuvant systemic treatment.~   "
231324|NCT00528554|"~     To investigate whether nonthermal low level laser acupuncture has beneficial effects on~     nausea and vomiting in children receiving highly emetogenic chemotherapy for a malignant~     solid tumor. In a previous crossover study comparing needle acupuncture to no intervention in~     an otherwise similar setting we found beneficial effects, but this trial was not even~     single-blinded and therefore the results are questionable. The hypothesis is that active~     laser acupuncture is more effective than placebo laser acupuncture concerning episodes of~     retching/vomiting (primary outcome measure) and rescue antiemetic medication (secondary~     outcome measure) with a fix standard antiemetic medication~   "
231325|NCT00528541|"~     The purpose of this study is to compare two types of botulinum toxin type A to treat the~     involuntary muscle contractions in the neck~   "
231326|NCT00528528|"~     The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics~     (the study of the way a drug enters and leaves the blood and tissues over time), and~     pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different~     doses in combination with two standard therapies commercially available for chronic (lasting~     a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.~   "
231327|NCT00528515|"~     The purpose of this study is to prove if anesthesia maintained with the inhaled volatile~     anesthetic desflurane is superior to the intravenously applied propofol anesthesia in~     off-pump coronary artery bypass grafting (OP-CABG) surgery as measured by following~     parameters:~        1. hemodynamic parameters during and after the operation,~        2. pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital~          stay,~        3. release of heart muscle injury markers in response to surgery and intraoperative~          ischaemia,~        4. inflammatory response to the operation.~      We suspect that insufflation anesthesia with desflurane may be superior to intravenous~     anesthesia with propofol.~   "
231328|NCT00528502|"~     Primary Objective:~      1. To determine if the application of lidocaine to the airway will obtund or abolish the~     laryngeal reflexes. This in turn will lead to a quiescent controlled surgical field.~   "
231329|NCT00528489|"~     The purpose of this study is to determine the safety, tolerability, and immune response to~     the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of~     IL-15.~   "
231330|NCT00528476|"~     The purpose of this study is to determine clinical and urodynamic risk factors for recurrent~     urinary tract infection in 5-18 years old children.~   "
231331|NCT00528463|"~     Phantom limb pain is a complication of amputation. Although pre-empitve epidural analgesia~     was once thought to prevent such a com plication, recent studies did not demonstrate this.~     Peripheral blocks are more powerful then epidurals, and can even influence somatotropic~     representation in the brain. This a prospective case series in which the investigators hope~     to show a decrease, against historical control, of the incidence of post-operative amputation~     lower limb phantom pain. The investigators established the block at least 24 hours~     pre-operative and continue it for at least 2 days. Patient are followed daily for the 1st 3~     days and then up to 3 month for the incidence of phantom limb pain. The investigators hope to~     recruit 30 patients.~   "
231363|NCT00528047|"~     The purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it~     has on patients and their cancer. This study will also determine the highest dose of PRLX~     93936 that can be given without causing adverse side effects and the dose of PRLX 93936 that~     should be used in future studies.~   "
231332|NCT00528450|"~     RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and~     spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving tretinoin together with arsenic trioxide with or without~     idarubicin may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving tretinoin together with arsenic~     trioxide with or without idarubicin works in treating patients with acute promyelocytic~     leukemia.~   "
231333|NCT00528437|"~     The purpose of this study is to:~      Find out how safe and effective (by monitoring the good and/or bad effects) treatment with~     high dose temozolomide, thiotepa and carboplatin with stem cell rescue followed by~     13-cis-retinoic acid has on children and adolescents with recurrent/refractory brain tumors~      Find out how the body uses 13-cis-retinoic acid by studying the your blood levels and~     proteins in the blood that break down the 13-cis-retinoic acid~      Determine how well 13-cis-retinoic acid penetrates into the spinal fluid.~   "
231334|NCT00528424|"~     Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857~     (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study~     AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further~     treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or~     proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less,~     the cord affecting that joint received less than three injections of AA4500, or they had~     other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option~     to receive up to five injections of AA4500 in this extension study. Subjects requiring~     further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each~     injection, with injections separated by four weeks. Follow-up visits for the determination of~     efficacy and safety were conducted on Day 90, Month 6, and Month 9.~      This study was designed to be part of the larger clinical program, for adult patients with~     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal~     Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7~     non-pivotal studies were evaluated.~   "
231335|NCT00528411|"~     The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet~     medication, affects platelets. Anti-platelet agents are medications that block the formation~     of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding,~     but when they form inside the arteries their formation is linked to a risk of medical~     problems such as heart attack and stroke. This study investigated how long it takes for~     Ticagrelor to begin working and how long it takes for it to stop working after the last dose~     of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment~     for preventing blood clots, and placebo plus Aspirin.~   "
231336|NCT00528398|"~     RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose~     cytarabine works in treating patients with acute myeloid leukemia.~   "
231337|NCT00528385|"~     The main purpose of the study is find whether the addition of aldosterone antagonist,~     spironolactone to dual renin-angiotensin-aldosterone system blockade involving angiotensin~     converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction~     of proteinuria, main prognostic marker of chronic kidney disease progression.~   "
231338|NCT00528372|"~     The purpose of this clinical research study is to determine whether dapagliflozin can improve~     (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated~     with medication or have been taking medication for less than 24 weeks since their original~     diabetes diagnosis. The safety of this treatment will also be studied.~   "
231339|NCT00528359|"~     The purpose of this study is to determine whether atypical antipsychotic drugs (commonly~     prescribed for treating schizophrenia) induce changes in anthropometry and metabolism,~     including alteration in insulin sensitivity and/or insulin secretion by the pancreas, when~     given to lean, non-diabetic, individuals who are antipsychotic drug(s)-naïve, and free of~     metabolic syndrome at enrollment.~   "
231340|NCT00528346|"~     The purpose of this study is to test a new investigational method for treatment of chronic~     pain using cognitive training guided by functional magnetic resonance imaging (fMRI).~   "
231341|NCT00528333|"~     The purpose of this study is to assess whether there is a survival benefit with lintuzumab~     given in combination with low dose cytarabine versus low dose cytarabine and placebo in~     patients with AML.~   "
231342|NCT00528320|"~     This study provides a continued access registry for cardiac resynchronization therapy with~     defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by~     helping the left ventricle contract (pump blood) more uniformly, in patients with severe~     heart failure (New York Heart Association [NYHA] Class III or IV).~      Quality of life, adverse events and device success will be analyzed and reported.~   "
231343|NCT00528307|"~     To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for~     atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr~     ejection fraction.~   "
231344|NCT00528294|"~     This trials examines the feasibility of GRID-therapy combined with biologically imaging based~     IMRT (BG-IMRT). Within this trial, the strict toxicity parameters of primary treatment of~     head and neck tumors are used. The GRID and BG-IMRT technique might be possible to reduce the~     total radiation dose 2 to 3 times.~   "
231361|NCT00528073|"~     This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is~     most effective in treating active moderate Crohn's disease. Rifaximin tablets are already~     marketed in some European countries and the USA to treat traveller's diarrhoea. A new~     gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be~     used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules~     which pass into the intestines and deliver Rifaximin directly to the site of the disease.~     Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of~     side effects.~   "
231481|NCT00526487|"~     The purpose of this study is to evaluate the safety and effectiveness performance of the~     Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the~     descending thoracic aorta.~   "
231345|NCT00528281|"~     This phase II study is a single-arm, two-stage, multicentre study to determine the clinical~     activity of lapatinib in combination with pemetrexed in patients with Non-Small Cell Lung~     Cancer (NSCLC) who have received one prior cytotoxic chemotherapy regimen. There will be a~     short safety run in portion of the study to determine the optimal treatment regimen (OTR) for~     the combination, since these two drugs have not previously been used together.~      Approximately 27 patients will be enrolled into the first stage of the study and if~     sufficient responses are seen an additional 27 patients will be enrolled into the second~     stage giving an overall evaluable patient number of 54. Patients will be treated with~     pemetrexed plus lapatinib at the determined OTR to disease progression, death or withdrawal~     from the study treatment for any reason.~      Safety and efficacy assessments will be performed on all patients at 6-week intervals, as~     well as at the end of treatment. Patients withdrawn from study treatment with stable disease~     will be assessed every 6 weeks until progression. Thereafter, patients will be followed for~     survival at approximately 12-week intervals until death or to a maximum of 5 years after last~     patient is enrolled, whichever comes first.~   "
231346|NCT00528268|"~     In this single-center trial, we will evaluate the effects of NaPB on presymptomatic Spinal~     Muscular Atrophy (SMA) type I (cohort 1)and presymptomatic SMA type II (cohort 2) infants. A~     variety of outcome measures will be performed at each study visit to follow the course of the~     disease. Total duration of the study for type I infants will be 18 months, for type II~     infants, 24 months.~   "
231347|NCT00528255|"~     This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal~     insert when administered to nulliparous women at term gestation requiring cervical ripening~     and induction of labor.~   "
231348|NCT00528242|"~     To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days~     2101 dosing period.~   "
231349|NCT00528229|"~     The purpose of the study is to compare Multi-Slice Computer Tomography findings with~     histological and physiological changes observed in transplanted lungs with Progressive Graft~     Disfunction.~   "
231350|NCT00528216|"~     The purpose of this study is to evaluate potential changes in epidermal nerve fiber~     immunostaining (ENFI) and sensory nerve function in healthy normal volunteers following~     single applications of three different investigational topical Capsaicin Dermal Liquids (10%~     w/v trans capsaicin), and a comparable control (propylene glycol). In addition, the pain and~     tolerability of the application of each formulation will also be assessed. Data from this~     clinical study may be used to select a formulation for further clinical evaluation.~   "
231351|NCT00528203|"~     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease~     that can cause intense pain episodes. The purpose of this study is to collect, test, and~     archive blood and DNA samples from children and adults with SCD to study the role that genes~     play in SCD. Blood and DNA samples will be stored for use in future SCD studies.~   "
231352|NCT00528190|"~     This clinical trial will attempt to determine whether we can improve clinical outcomes for~     patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.~   "
231353|NCT00528177|"~     The purpose of this study is to determine whether oxycodone provides better analgesia~     compared to morphine after laparoscopic hysterectomy or myomectomy.~   "
231354|NCT00528164|"~     The purpose of this study is to determine whether an intense family-centered program to help~     children, 4 to 7 years old, control their weight is more effective than the advise and~     referrals their health provider gives in the primary care office.~   "
231355|NCT00528151|"~     Background Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular~     disorder associated with a mutation in mtDNA . The common manifestation is visual loss which~     caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative~     stress enzymes production.~      Purpose To determine whether curcumin which is an antioxidant agent is beneficial to the~     patients with 11778 LHON mutation.~      Material and Method Seventy patients with 11778 LHON mutation were randomly treated with oral~     curcumin (500 mg/day) and placebo for 1 year. The visual acuity, computerized visual field,~     electrophysiologic parameters and oxidative stress enzymes in plasma were compared before and~     after treatment at 3, 6, and 12 months interval.~   "
231356|NCT00528138|"~     It has recently been published that hyperbilirubinemia is a reliable marker for the~     preoperative diagnosis of perforated acute appendicitis.~      The investigators believe, based on their own previous publications, that C-reactive protein~     (CRP) with or without a white blood cell count and some other clinical parameters, are more~     specific markers for the preoperative diagnosis of perforated acute appendicitis.~      The purpose of this study is to prospectively compare the specificity and sensitivity of~     hyperbilirubinemia CRP, white blood cell count and other clinical parameters for the~     preoperative diagnosis of acute appendicitis.~   "
231357|NCT00528125|"~     Pain prevention and/or therapy in neonates is still a challenge. It is widely accepted that~     early pain experience can have a tremendous impact on the pain memory. We want to investigate~     if a simple, fast method, that is nearly devoid of side effects can lead to a significant~     alleviation of pain sensation in neonates. Acupuncture has been shown to be effective in~     various painful conditions. Trials on acupuncture in children are rare. Trials on acupuncture~     in neonates are lacking so far. Our hypothesis is that neonates in the active laser group~     experience less pain than those in the placebo group.~   "
231358|NCT00528112|"~     This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS).~     The purpose of the study is to investigate which of the 2 administered doses is the lowest~     effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for~     contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5~     years~   "
231359|NCT00528099|"~     To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending,~     single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects~   "
231360|NCT00528086|"~     To determine patient satisfaction with group visits versus standard of care delivery for~     patients with Parkinson's disease.~   "
231362|NCT00528060|"~     the trial assessed the pharmacokinetics and long term plasma exposure of the following~     antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine~     fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor~     dosing history.~   "
231364|NCT00528034|"~     Primary Objectives:~        1. Determine the feasibility of using pretreatment lymphoscintigraphy to identify the~          sentinel lymph node(s) in patients with vaginal cancer dispositioned to receive~          radiation therapy.~        2. Determine the feasibility of using preoperative lymphoscintigraphy and intraoperative~          lymphatic mapping to identify the sentinel lymph node(s) in patients with vaginal cancer~          dispositioned to undergo surgery and bilateral lymph node dissection.~   "
231365|NCT00528021|"~     The main purpose of this study is to investigate the safety and efficacy of an~     investigational treatment for head lice infestation against a placebo.~   "
231366|NCT00528008|"~     The purpose of this study is to find out if chlorhexidine gluconate solution is better at~     reducing the rate of wound infection after cesarean section compared to povidone-iodine.~   "
231367|NCT00527995|"~     This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg~     sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects~     on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular~     autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.~   "
231368|NCT00527982|"~     Primary Objectives:~        1. To examine the effect of celecoxib treatment on histological response, markers of~          proliferation (Ki-67), and apoptosis. Secondary endpoints include time to second primary~          or recurrence and survival.~        2. To examine the toxicity associated with celecoxib administration in patients with~          previously treated Head and Neck Head and neck squamous cell carcinomas (HNSCC)or~          Non-small-cell lung carcinoma (NSCLC).~   "
231369|NCT00527969|"~     The purpose of this study is to determine the efficacy and safety of REMEMBER-fX (HT1001, an~     extract of Panax quinquefolius) in a human sample using standard clinical neuropsychological~     instruments and side effects rating scales.~   "
231370|NCT00527956|"~     To date, there is a paucity of research focusing on maternal breastfeeding goals, how these~     goals may change after an unexpected event such as a preterm birth, and how mothers of ill~     and preterm infants define breastfeeding success. No studies were identified that focused~     exclusively on the breastfeeding goals of mothers of hospitalized preterm infants~      The purpose of this study is to answer the following research questions: 1) What are the~     breastfeeding goals of mothers with preterm infants in the NICU? and 2) What are mothers'~     perceptions of facilitators and barriers to meeting their breastfeeding goals in the NICU?~   "
231371|NCT00527943|"~     The study is designed to determine whether vorapaxar, when added to the existing standard of~     care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute~     coronary syndrome, will yield additional benefit over the existing standard of care in~     preventing heart attack and stroke.~      The study is also designed to assess risk of bleeding with vorapaxar added to the standard of~     care versus the standard of care alone.~   "
231372|NCT00527930|"~     Phase II trial of oxaliplatin in combination with S-1(SOX) in patients with recurrent or~     metastatic breast cancer (MBC) previously treated with or resistant to an anthracycline and~     taxane~   "
231373|NCT00527917|"~     This is a pilot clinical investigation. Patients who meet the eligibility criteria and~     provide signed informed consent will be randomized to receive either an active product~     (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6~     weeks of follow-up period.~   "
231374|NCT00527904|"~     This study uses an open-label design and will be conducted in approximately 60 sites aiming~     to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12~     months exposure to PN400 (VIMOVO).~   "
231375|NCT00527891|"~     Primary Objective:~      1. To compare the efficacy of 1.5T vs. 3T T1 and T2-weighted MR images sequences for the~     detection and evaluation of liver lesions.~   "
231376|NCT00527878|"~     This study will examine the safety and effectiveness of ranitidine (Zantac) in patients with~     Hyper-IgE recurrent infection syndrome, a disease characterized by recurrent infections of~     the ears, sinuses, lungs and skin, and abnormal levels of the antibody immunoglobulin E~     (IgE).~      Patients age 2 and older who have Hyper-IgE recurrent infection syndrome and who have had~     chronic or frequent infections in the last 12 months may be eligible for this study.~      Participants are randomly assigned to take ranitidine or placebo in pill or liquid form twice~     a day for 12 months. In addition to treatment, patients undergo the following procedures~     during visits scheduled on day 0 of the study (baseline) and at 3, 12, 15 and 24 months.~     Evaluations at 6, 9, 18 and 21 months are by telephone.~        -  Medical history and physical examination - baseline and 3 and 24 months.~        -  Clinical severity score - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months.~        -  Dermatology exam - baseline and 3, 12, 15 and 24 months.~        -  Pulmonary function test - baseline and 12 and 24 months.~        -  Chest CT - baseline and 12 and 24 months.~        -  Quality of life assessment - baseline and 3, 12, 15 and 24 months.~        -  Pregnancy testing - baseline and 3, 12, 15 and 24 months.~        -  HIV test - baseline and 12 and 24 months.~        -  Contraception evaluation - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months.~        -  Missed school/work days assessment - baseline and 3, 12, 15 and 24 months.~        -  Medication adherence - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months.~      In addition to the above procedures, participants who are not enrolled in study 00-I-0159~     have a baseline scoliosis series and genetic consult.~   "
231377|NCT00527865|"~     This study will evaluate the safety, tolerability, and systemic exposure of an experimental~     influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is~     administered via oral inhalation using a special device. Study participants will include up~     to 60 healthy, non-smoking males and females, ages 18-65. They will be given either DAS181 or~     placebo. Participants will remain in the clinic overnight to be watched for health changes~     for 24 hours after receiving the medication. Study procedures include: physical exams, chest~     x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs.~     Follow-up visits will occur on study days 2, 7, 14 +/- 1 day, and 30 +/- 2 days. Participants~     will be involved in the study for up to 61 days, which includes the screening period.~   "
231378|NCT00527852|"~     This is a study to to compare traditional fibre wound swabs to more recently developed~     flocked swabs for the identification of Group A streptococcal pharyngitis in children~     presenting to a children's emergency department.~   "
247272|NCT00316394|"~     To determine the effectiveness of a single checklist reminder form to improve the delivery of~     preventive health services at adult health check-ups in a family practice setting.~   "
231379|NCT00527839|"~     Total joint replacements are some of the most successful medical devices developed over the~     last fifty years. They enable millions of people to remain ambulatory and pain free, with~     minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements,~     and 25,000 total or partial shoulder replacements were performed in the United States (HCUP~     data). Future use will likely be even higher: it is estimated that by the year 2020, the~     population 65 and over in developed countries will increase by 71%. Existing studies do not~     provide adequate prospective data to evaluate long-term outcomes.~      HSS is a world leader in total joint replacement including total shoulder arthroplasty.~     However, there is no systematic follow-up or evaluation of patients who have their shoulders~     replaced here.~      The purpose of this study is to establish a prospective cohort of HSS total shoulder~     arthroplasty to evaluate predictors of outcome, causes of failure and to allow ongoing~     evaluation of the results of our patients over time.~   "
231380|NCT00527826|"~     This is a 12 month randomized, open-label, parallel-group study to obtain data on the~     frequency and variability of exacerbations in severe and very severe Chronic Obstructive~     Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease~     (GOLD) Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in~     fixed combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200~     subjects will be enrolled in approximately 30 study centres in Germany. Data on health care~     utilisation will be collected to compare direct costs associated with COPD in these two~     groups.~      Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be~     randomized to receive either SFC 50/500 µg bid (twice daily) as fixed combination or Sal 50~     µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects~     will return for study visits every two to three months until week 52. Additional telephone~     calls will be made between scheduled visits every 4 weeks. Assessments will include~     monitoring of frequency of exacerbations, health care utilisation (including emergency visits~     and hospitalizations) and rescue medication, lung function, drug compliance, health-related~     quality of life (SGRQ = St George's Respiratory Questionnaire) and safety.~   "
231381|NCT00527813|"~     We project to test the effect of prone position on mortality in severe ARDS patients~     (PaO2/FiO2<150 with FiO2 > or = 0.6 and positive end-expiratory pressure > or = 5 cmH2O).~     Ventilator will be set in accordance with current standards aiming at protecting the lungs~     from VALI. Patients will be randomized into two arms: prone group in which proning will be~     realized for at least 16 hours a day and supine group in which patients will stay in a~     semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary~     end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia.~     Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45%~     percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each~     arm.~   "
231382|NCT00527800|"~     This is a prospective cohort study where HIV-infected and uninfected children will be~     enrolled between 6 weeks and 9 months of age and followed to the age of 21 months. All~     HIV-infected children will be given trimethoprim-sulfamethoxazole (TMP-SMX) prophylaxis as of~     6 weeks of age. HIV-uninfected children born to HIV-infected mothers will be given TMP/SMX~     prophylaxis for the duration of breastfeeding and then randomized to the continuation of~     TMP/SMX or discontinuation of TMP/SMX prophylaxis. HIV-uninfected children born to~     HIV-uninfected mothers will not be given TMP/SMX prophylaxis. Study participants will be~     followed for all of their health care needs in a designated study clinic. All mother-child~     pairs will receive a basic care package including insecticide-treated bednets (ITNs) at~     enrollment. All HIV-infected mothers and children will receive antiretroviral therapy if~     eligible according to standardized World Health Organization (WHO) criteria. Study~     participants 4 months of age or older and at least 5 kg will be randomized to treatment with~     artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) at the time of their~     first diagnosis of uncomplicated malaria. Study participants will receive the same~     antimalarial treatment regimen for all future episodes of uncomplicated malaria. Study~     participants less than 4 months of age or less than 5 kg diagnosed with malaria and all~     episodes of complicated malaria will be treated with quinine in accordance with local~     guidelines.~      The investigators will test the hypotheses that:~        1. TMP/SMX prophylaxis is highly effective in preventing malaria in both HIV-infected and~          HIV-uninfected children~        2. The use of TMP/SMX prophylaxis is associated with an increased risk of infection with~          malaria parasites containing antifolate resistance-conferring mutations.~        3. The use of antiretroviral (ARV) drugs is associated with a decreased incidence of~          malaria.~        4. The efficacy, safety, and tolerability of AL and DP for the treatment of uncomplicated~          malaria differ.~           In 2008, we received approval and funding to extend the trial until 2012. We are now~          following all children through 5 years of age. First randomization to continue or~          discontinue TMP/SMX prophylaxis in our HIV-exposed population occurs 6-8 weeks after~          cessation of breastfeeding when HIV status can be confirmed as negative by DNA PCR. A~          second randomization occurs at 2 years of age in our HIV-exposed participants. At that~          point all HIV-exposed children who were originally randomized to continue TMP/SMX~          prophylaxis are again randomized to either immediately discontinue TMP/SMX prophylaxis~          or continue prophylaxis until age 4 years. All children will be off TMP/SMX between 4~          and 5 years of age.~           We have also added an additional hypothesis to test during the study extension:~        5. Prolonged TMP/SMX prophylaxis will result in an increased incidence of malaria in~          children in the year immediately following cessation of prophylaxis compared to children~          who have not used prophylaxis for over a year and those who have never been on~          prophylaxis.~   "
231383|NCT00527787|"~     This study uses a randomized, double-blind, controlled design to demonstrate that PN400~     (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal~     ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric~     ulcers compared to naproxen alone.~   "
231384|NCT00527774|"~     The purpose of this study is to study whether hepatitis C virus (HCV)infected maintenance~     hemodialysis (MHD)patients have distinct metabolic, inflammatory and adipokine~     characteristics that can be linked to poor clinical outcome and to examine the hypothesis~     that HCV infected MHD patients with metabolic syndrome have higher risks for hospitalization,~     cardiovascular and all-cause mortality.~   "
231385|NCT00527761|"~     Primary Objective:~      1. To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin~     (TTC) in patients with metastatic melanoma.~      Secondary Objectives:~        1. To determine the toxicity of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in~          patients with metastatic melanoma~        2. To determine the response rate of induction chemotherapy using Taxotere, Temodar,~          Cisplatin (TTC) in patients with metastatic melanoma.~   "
231386|NCT00527748|"~     Range of motion at ankle joint and subtalar joint will be assessed before and after~     utilization of ARM device. The changes in range of motion will be recorded and compared to~     literature.~   "
231387|NCT00527735|"~     The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin~     has clinical benefit when compared with paclitaxel/carboplatin alone in patients with~     previously untreated lung cancer.~   "
231388|NCT00527722|"~     The purpose of this study is to demonstrate safety and effectiveness of the Bio-Seal Biopsy~     Track Plug in a clinical setting for use in lung biopsy procedures to reduce the rate of air~     leaks, commonly associated with the procedure. The Bio-Seal System is cleared in the U.S.~     with an indication for use as a lung biopsy site marker.~   "
232254|NCT00516243|"~     This randomized phase I trial studies the side effects and best dose of defined green tea~     catechin extract in treating women with hormone receptor-negative stage I-III breast cancer.~     Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.~   "
231389|NCT00527709|"~     This pilot study is being pursued to observe whether certain medications are given to~     patients within a timeframe where their being given could play a part in a critical event in~     the management of the patient.~      There are general rules about when it would be appropriate for these types of medications not~     to be given. However, it is not current standard practice for the criteria to be put in place~     without the expressed wishes of the ordering physician or their agent.~      Research Question:~      Can the administration of cardio-depressant medications be documented as a significant risk~     factor for hypotensive or bradycardic events?~   "
231390|NCT00527696|"~     To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal~     obturator tape (TVT-O) procedures for the surgical management of female stress urinary~     incontinence.~   "
231391|NCT00527683|"~     The primary objective of this study is to assess the efficacy of vigabatrin for the treatment~     of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine.~     Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject~     double- blind, randomized study is designed to show if with vigabatrin treatment but not~     placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine~     will become cocaine abstinent if they are self motivated to stop their cocaine habit. To~     accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or~     vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that~     as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase~     in the number of subjects who are abstinent for the final 3 weeks of the study.~   "
231392|NCT00527670|"~     The aim of this study is to compare collagen composition in the skin and fascia of patients~     with recurrent or incisional hernias versus normal controls. We will identify potential genes~     responsible for genetic alterations in collagen deposition by using gene chip analysis of the~     tissue obtained and comparing the hernia group versus controls. The ultimate goal of this~     study is to identify target genes which may help us eventually predict which patients are at~     risk for developing post-operative hernias.~   "
231393|NCT00527657|"~     The goal of this clinical research study is to find the highest safe dose of lomustine (CCNU,~     CeeNUTM) that can be given with temozolomide (TemodarTM) and thalidomide (ThalomidTM) in the~     treatment of metastatic melanoma that has spread to the brain. The safety and effectiveness~     of this combination therapy will also be studied.~   "
231394|NCT00527644|"~     The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic~     cholecystectomy. A hepato-iminodiacetic acid (HIDA) scan will be completed on post operative~     day one to check for biliary leaks.~   "
231395|NCT00527631|"~     The prognosis for patients with advanced epithelial ovarian cancer remains poor despite~     aggressive surgical resection and platinum-based chemotherapy. More than 60% of patients will~     develop recurrent disease, principally intraperitoneal, and die within 5 years. The use of~     whole abdominal irradiation (WAI) as consolidation therapy would appear to be a logical~     strategy, but despite whole abdominal irradiation has clinically proven efficacy the use of~     radiotherapy in ovarian cancer has profoundly decreased mainly due to high treatment-related~     toxicity. Modern intensity-modulated radiation therapy (IMRT) could allow to spare kidneys,~     liver, and bone marrow while still adequately covering the peritoneal cavity with a~     homogenous dose.~      This study will evaluate feasibility and toxicity of adjuvant consolidation whole abdominal~     intensity modulated radiotherapy (IMRT) for high risk stage FIGO III patients with ovarian~     cancer.~   "
231396|NCT00527618|"~     To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus~     standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV~     reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The~     investigators hypothesize that high-dose valacyclovir will result in greater reduction in~     plasma HIV-1 and genital HSV reactivation.~   "
231397|NCT00527605|"~     This randomized, double-blind, placebo-controlled, six-month parallel-group study assess~     efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic~     Hyperplasia (BPH) , followed by a 12-month open-label treatment phase~   "
231398|NCT00527592|"~     The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in~     the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.~   "
231399|NCT00527579|"~     The purpose of this protocol is to measure peripheral benzodiazepine receptors in the brain~     using positron emission tomography (PET) and compare the imaging results between patients and~     healthy people.~   "
231400|NCT00527566|"~     The purpose of this study is to determine whether Mepolizumab (a monoclonal antibody against~     interleukin-5) is a safe and well-tolerated therapy that will allow for steroid tapering in~     patients with steroid-dependent Churg-Strauss Syndrome (CSS).~   "
231401|NCT00527553|"~     Age-related macula degeneration (AMD, encompassing both dry and wet form), the late stage of~     Age-related maculopathy (ARM), is the leading cause of blindness in many developed countries~     in older persons (usually over 60 years of age). Visual compromise rises exponentially after~     the age of 70 with a 5-year incidence of around 1%. Studies have shown a possible protective~     effect of lutein on progression of AMD, where visual acuity improves after increased lutein~     intake. The incidence of bilateral AMD in persons with unilateral late ARM observed over a~     period of 10 years is over 50% with a 2.1-2.8% overall incidence in the study population.~      Blue light hazard (excitation peak 440 nm) was shown to have a major impact on photoreceptor~     and RPE function inducing photochemical damage and cellular apoptosis, leading to retinal~     degeneration in an animal study. The current belief is that lutein accumulated in the macular~     region helps in the prevention of blindness by absorbing blue light and protecting the retina~     from oxidative stress. With the lipid matrix of the egg yolk being a proven vehicle for the~     efficient absorption of dietary lutein, it might be possible to increase plasma levels of~     lutein to therapeutic levels and control or prevent AMD. This, the investigators hope, will~     be accomplished by means of filtering out harmful blue light and the scavenging of free~     radicals by lutein and zeaxanthin.~   "
231402|NCT00527540|"~     Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated~     Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current~     this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a~     (Pegaferon®) in the patients with chronic hepatitis C.~   "
231403|NCT00527527|"~     This randomized clinical trial pilot study will investigate the efficacy of different amounts~     of total treatment dosage over six weeks in 60 volunteer subjects with lumbar spinal~     stenosis. Subjects will be evenly randomized into four groups of either flexion distraction~     (FD) care or a control: Group 1 with 8 total FD treatment visits, Group 2 with 12 total FD~     treatment visits, Group 3 with 18 total FD treatment visits, or Group 4 with 8 total placebo~     control visits. The study is designed: (1) To determine the feasibility of a larger scale~     study in terms of logistics, recruitment efforts, and sample size estimations and (2) To~     determine among the three treatment groups the change in perceived pain levels and general~     functional health status at the end of six weeks of treatment and at three months post care~     as follow-up.~   "
231404|NCT00527514|"~     This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan~     treatment regimen in stage 1 and stage 2 hypertensive subjects.~   "
231405|NCT00527501|"~     The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed~     combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN~     dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.~   "
231406|NCT00527488|"~     This exploratory study will be conducted open label in a single investigational clinical~     unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned~     to receive 4 different treatments with degarelix.~   "
231407|NCT00527475|"~     Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set~     the standard for visual outcomes in treating wet macular degeneration. However, they need to~     be administered frequently by intraocular injections with the attendant risk of~     endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of~     this trial is to see if using photodynamic therapy in combination with ranibizumab will~     decrease the number of treatments with ranibizumab.~   "
231408|NCT00527462|"~     The aim of the study is to test the hypothesis that the allergic airway inflammation in~     asthmatic patients will be enhanced after exposure to ultrafine particles (UFP). In order to~     test this in a controlled study, the researchers combine controlled exposure to carbon black~     model UFP with the well-established model of a segmental allergen challenge, which allows the~     researchers to safely induce circumscript allergic inflammation in the lung in mild~     asthmatics. The effect of the UFP on allergic inflammation will be controlled by an~     inhalation of clean air in a randomized, double-blind, crossover design.~   "
231409|NCT00527449|"~     The purpose of this study is to optimize results in neoadjuvant chemotherapy of local~     advanced primary breast cancer. Therefore patients become first 3 cycles of~     Epirubicin/Docetaxel followed by 3x Carboplatin/Docetaxel.~   "
231410|NCT00527436|"~     Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty~     acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic~     acid (DHA), and risk of developing cardiovascular disease in healthy adults. Mechanisms~     underlying this cardioprotective effect are unknown but may involve favorable influences on~     various biomarkers of cardiovascular risk. In this project we will determine if these~     favorable effects of omega-3's occur in older healthy adults, as aging is a primary risk~     factor for cardiovascular disease development.~      Key Objectives To determine the effect of chronic (12 week) oral omega-3 fatty acid~     supplementation on biomarkers of cardiovascular risk in young and older adults. We~     hypothesize that omega-3 fatty acid supplementation will exert positive effects on biomarkers~     of cardiovascular risk.~      Study Population Healthy young (18-40 years of age) and older (50-79) men and women.~      Major Inclusion & Exclusion Criteria Subjects must be healthy (as assessed by history and~     physical examination: non obese BMI<30: normotensive BP <140/90 mmHg) men and women not~     currently taking medications that could influence the results. Women must be non-pregnant.~     Normal liver enzymes (ALT and AST). Individuals with allergies to corn will be excluded.~      Allocation to Groups Randomized, double-blinded, and placebo-controlled.~      Summary of Procedures Measurements will be made at baseline and repeated ~12 weeks after~     beginning daily oral ingestion of either low dose or high dose fish oil capsules or placebo~   "
231411|NCT00527423|"~     Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective~     is to assess long-term safety and tolerability of continuing intravitreal treatment in~     subjects with wet age-related macular degeneration.~   "
231412|NCT00527410|"~     This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in~     recurrent neoplastic meningitis.~   "
231413|NCT00527397|"~     Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week)~     administration to Type 1 and Type 2 diabetes patients (non-smokers)~   "
231414|NCT00527384|"~     Physiological changes can occur from different types of stress as induced by an infection, an~     environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can~     modify health by lessening defense mechanisms as maintained by the immune system. The ability~     of different forms of stress to alter physiological processes (body functions) will be~     assessed by monitoring the blood profile of cell numbers and functions as well as the plasma~     protein content. It is anticipated that the pattern of blood changes will reflect the types~     of stress and the degree to which body functions could be altered by the stress.~   "
231415|NCT00527371|"~     In patients with an enlarged prostate (benign prostatic hyperplasia), is treatment using~     photoselective vaporization of the prostate (PVP 120 Watt) as effective and cost-effective as~     the standard treatment of transurethral resection of the prostate (TURP)? A higher-power~     (120W) laser system has recently been approved by Health Canada for the treatment of an~     enlarged prostate. This system, which uses laser energy to vaporize the prostate tissue, will~     be compared with the current standard treatment of transurethral resection of the prostate.~     This newer generation laser may offer more efficient removal of prostate tissue with fewer~     complications and may result in clinical and economic benefits compared to the standard~     treatment. However, there have been no studies comparing the 120W laser with the standard~     transurethral resection of the prostate. This study will provide currently unavailable~     information for clinicians and decision makers.~   "
231416|NCT00527358|"~     This is an evaluation of a primary prevention program to prevent youth violence by improving~     family cohesion, networking among families, school bonding, and access to services for~     Latinos in Langley Park, MD.~   "
231417|NCT00527345|"~     The contribution of diesel exhaust (DE) to health, especially children's health, is of~     tremendous public health interest. DE has been associated with worsening asthma and~     allergies, among other important health effects. Reducing DE exposures has become a major~     regulatory initiative, and federal, state, and local jurisdictions are investing hundreds of~     millions of dollars in retrofitting diesel engines in school buses and other changes to reach~     this goal.~      The U.S. Environmental Protection Agency's recent regulations require all on-road diesel~     vehicles to change to low emission engines and ultra-low-sulfur fuels by 2007 (US EPA '00).~     In spring 2003, the U.S. EPA announced a nationwide voluntary school bus retrofit initiative.~     In July 2003, the Washington Legislature enacted a statewide Diesel Solutions program that~     provides 25 million dollars by 2008 to retrofit school diesel buses with cleaner burning~     engines and fuels, making it one of the largest and most active voluntary school bus retrofit~     program in the country. If risk assessment estimates are accurate, these changes will have a~     large public health impact, especially on children who ride school buses daily. However, no~     studies to-date have rigorously examined school children's exposure to diesel exhaust (DE)~     and its health effects, nor such a significant change in vehicular pollution control. We~     propose to seize this opportunity of a large natural experiment taking place in the Puget~     Sound area and conduct a study to assess health effects from diesel bus exhaust before and~     after the retrofit of diesel bus fleets between 2005 and 2007. The specific aims of the study~     are to:~        1. Determine whether asthmatic children changing to retrofitted buses with cleaner fuels~          and engines have a reduction in sub-clinical and clinical asthma severity.~        2. Determine if increased levels of DE exposure lead to an increase in acute clinical and~          sub-clinical features of asthma in children.~        3. Quantify the levels and changes in particle and toxic gas exposures to DE in 3 groups of~          children commuting to school by retrofitted buses or private cars, old diesel buses to~          be retrofitted later, and old diesel buses through the study.~      Sub-aim 3: Use the time-activity information, personal exposure measurements, and on-bus~     monitoring data to construct an exposure model to predict individual exposures to DE for all~     subjects.~   "
231418|NCT00527332|"~     The purpose of this study is to determine whether spinal anesthesia combined with intrathecal~     morphine in abdominal hysterectomy on benign gynecological indications gives better outcome~     concerning duration of hospital stay and postoperative patient comfort than general~     anesthesia.~   "
231419|NCT00527319|"~     Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a~     hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are~     not functioning and increased nutrition is not utilized.~      To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy~     must block multi-factorial stress signaling a threshold of activation. Consistent with the~     synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with~     advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of~     VT-122 in subjects with NSCLC who have hypercatabolic cachexia.~   "
231420|NCT00527306|"~     The purpose of this research study is to find out if taking a multivitamin daily can affect~     the number of canker sores that people get and how long they last. Previous studies have~     shown that people who get canker sores are more likely to be deficient in one or more~     vitamins. It has also been found that correction of such vitamin deficiencies reduces the~     number and duration of canker sores. However, it is not known if taking a multivitamin daily~     will reduce the number and duration of canker sores.~   "
231421|NCT00527293|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. Giving radiation therapy in different ways may kill more tumor cells.~      PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in~     treating women undergoing breast-conserving therapy for early stage breast cancer.~   "
231422|NCT00527280|"~     To show the feasibility of face transplantation in patients~   "
231423|NCT00527267|"~     Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a~     maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed~     throughout the study along with PRO assessments.~   "
231424|NCT00527254|"~     The purpose of this study is to evaluate the impact of a a real time teleassistance system in~     the clinical evolution of type 2 diabetic patients on self monitoring blood glucose in the~     Public National Primary Care System.~   "
231425|NCT00527241|"~     This trial will test the impact of a culturally tailored and theory driven primary intimate~     partner violence prevention intervention with Spanish speaking Latino men.~   "
231426|NCT00527228|"~     The present study is designed to assess the natural history in a one year pre-phase of the~     trial and evaluate therapeutic efficacy and side effects of deflazacort in LGMD2B/MM patients~     in a placebo-controlled trial. Furthermore, long-term development of the disease under~     naturalistic conditions will be documented in a 2-year follow-up after the end of the~     double-blind treatment phase.~   "
231427|NCT00527215|"~     Multicenter, open label single arm study in which 140 subjects with CRI who are currently~     receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every~     4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa~     once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total~     dose in the month preceding enrollment. Doses may be titrated to maintain the Hb~     concentration in the target range.~   "
231428|NCT00527202|"~     Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A~     injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve~     trauma)~   "
231429|NCT00527189|"~     Arthritis has been reported as a risk factor for falls. Few studies have investigated the~     effect of balance training on balance performance in women with lower limb arthritis. The aim~     of this study was to evaluate the effectiveness of a four-month individualised home exercise~     programme in improving gait stability and balance for women with arthritis.~   "
231430|NCT00527176|"~     In daily clinical use, pulse high dosis corticosteroids are used to treat cerebral edema in~     different pathological situations ( surgery, trauma, tumors...). Dehydration can theorically~     concern extra-cellular or intracellular water, or both.~      The relative proportion of those two components are not known, as well their kinetics.~      Diffusion Weighted Imaging ( DWI) is a none invasive and none toxic technique to study those~     phenomena.We can also study the diffusivity anisotropy not using a Gaussian distribution but~     rather a non- gaussian one, more close to the reality ( q Space Imaging ).~      Finally, we can study the compartment redistribution between slow and rapid water molecules~     diffusion by bi-exponential decomposition of the diffusion signal, corresponding,~     theorically, respectively to the intra- and extra-cellular component.~      Hypothesis : The high dosis steroid pulse therapy modifies or not the water free diffusion in~     DWI and qSI ? Is there a modification in the diffusivity of both rapid and slow component ?~   "
231550|NCT00525577|"~     This double-blind, placebo-controlled, dose-finding study is designed to identify the lowest~     AGI-1067 dose that improves glycemic control as measured by HbA1c and fasting glucose in~     subjects with Type 2 diabetes mellitus. Glycemic control will be measured during a 6-month~     treatment period in subjects who are on 1 or no antidiabetic drugs~   "
231431|NCT00527163|"~     This study, conducted by NIH, the University of Bamako in Mali, Africa, and Tulane University~     will examine the relationships between hemolysis (breakdown of red blood cells), nitric oxide~     (a gas important in regulating blood vessel dilation and blood flow) and pulmonary~     hypertension in patients with malaria. Malaria is among the leading causes of death in many~     of the world s poorest countries. It is caused by a parasite that is transmitted to humans by~     mosquitoes.~      Malian children ages 1-5 years are eligible for participation in this study. They include~     children with asymptomatic infection, uncomplicated disease, and severe disease. Uninfected~     controls are also included.~      Upon enrollment, participants have a medical history and physical examination, echocardiogram~     (ultrasound test of heart function) and blood tests. In addition, all participants (infected~     children and controls) have repeat evaluations when healthy, approximately 7 to10 days~     following successful therapy....~   "
231432|NCT00527150|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     escalating multiple oral doses of varenicline AMT 8 controlled release formulation for 14~     days in adult smokers.~   "
231433|NCT00527137|"~     Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger.~     Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and~     baseline period. During the study, procedures include bloodwork for laboratory assessments~     and vital signs. Dose titration determined by hemoglobin values taken weekly during the~     study. Antibody samples taken at baseline and during the end of study assessments. A physical~     examination and laboratory tests will conclude the study.~   "
231434|NCT00527124|"~     This randomized phase II trial is studying how well giving docetaxel and prednisone together~     with or without cediranib works in treating patients with metastatic prostate cancer that did~     not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and prednisone,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Cediranib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel~     together with prednisone, with or without cediranib, may kill more tumor cells.~   "
231435|NCT00527111|"~     The purpose of this research study is to find out what effects (good and bad) cetuximab has~     on rectal cancer.~   "
231436|NCT00527098|"~     The purpose of this study is to determine if the overall fluid requirements for the first 24~     hours after admission will be reduced with Hextend versus a standard of care crystalloid~     resuscitation fluid.~   "
231437|NCT00527085|"~     4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the~     study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In~     addition, a bone biopsy will be performed at screening and at the end of study.~   "
231438|NCT00527072|"~     The purpose of this study is to test the safety and effectiveness of infliximab in patients~     with plaque psoriasis who have been receiving the drug etanercept for treatment of their~     plaque psoriasis for at least four months, without enough improvement in their psoriasis~     symptoms.~   "
231439|NCT00527059|"~     The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to~     standard therapy,on renal function in patients with Acute Heart Failure,compared with~     standard therapy alone.~   "
231440|NCT00527046|"~     A 24-month, placebo controlled, double dummy, parallel-design outpatient trial in generally~     healthy elderly men and women who are at risk of becoming frail.~   "
231441|NCT00527033|"~     Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability~     compared to placebo~   "
231442|NCT00527020|"~     GSK1018921 is a new drug under development for the treatment of schizophrenia. GSK1018921~     differs from other available drugs in its mode of action and it is assumed that it may have~     an effect in the treatment of so-called positive symptoms such as hallucinations and negative~     symptoms such as lack of drive. No clinical studies have been conducted with GSK1018921 in~     humans until now. This is the first study where this compound is administered to humans; the~     study has 2 parts: Part A is a dose escalation study, Part B is a pharmacodynamic portion in~     a separate group of healthy smoker volunteers.~   "
231443|NCT00527007|"~     The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock~     patients' outcome. The aim of this multicenter randomized controlled trial is to determine~     whether external cooling might accelerate improvement in cardiovascular function.~   "
231444|NCT00526994|"~     This is a randomized controlled trial with three arms to establish the impact of screening~     and referral to services for women disclosing exposure to IPV.~   "
231445|NCT00526981|"~     The study will test the hypothesis that the prone position can be used to reduce the need for~     intubation and mechanical ventilation in patients with acute respiratory failure.~   "
231446|NCT00526968|"~     The purpose of this study is to investigate the neurophysiological changes following single~     doses of EVT 101 using fMRI during rest and during cognitive tasks in young healthy male~     subjects.~   "
231447|NCT00526955|"~     To investigate the effect of duration of Applied Kinesiology manual muscle testing on~     strong versus weak result of the test.~   "
231448|NCT00526942|"~     The primary objective of this study is to evaluate the learnability of a 3 week, 40 minutes~     per day, 5 day per week, computer-based visual training exercise by healthy mature~     individuals undergoing normal aging.~   "
231449|NCT00526929|"~     Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with~     Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time~     blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC~     darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be~     titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study,~     laboratory assessments will be completed and vital signs will be taken. Subjects will enter a~     1-week post-treatment observation and evaluation period after the last dose of study drug.~   "
231450|NCT00526916|"~     The purpose of this protocol is to measure peripheral benzodiazepine receptors in the brain~     using positron emission tomography (PET) and compare the imaging results between patients and~     healthy people.~   "
231551|NCT00525564|"~     This study was designed to test the following hypothesis:~      The acute changes in exercise tolerance during the endurance shuttle walk will be greater~     with salmeterol compared to placebo in patients with chronic obstructive pulmonary disease.~   "
231451|NCT00526903|"~     The purpose of this study is to:~        1. To determine if fiber versus placebo improves symptoms in children with recurrent~          abdominal pain/irritable bowel syndrome.~        2. To determine possible ways fiber or placebo improve(s) symptoms in children with~          recurrent abdominal pain/irritable bowel syndrome by carrying out gastrointestinal tests~          and questionnaires.~      Understanding how diet and fiber affect GI function potentially will benefit the large~     numbers of children with irritable bowel syndrome (IBS) and provide insight into prevention~     of IBS in at risk children. We expect that the results from these studies can be used to~     lessen significantly the huge financial burden to society caused by these chronic conditions.~      Consent will be obtained from the parent/guardian and assent from the child.~   "
231452|NCT00526890|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with~     selenomethionine and radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works~     when given together with carboplatin, paclitaxel, and radiation therapy in treating patients~     with stage III non-small cell lung cancer that cannot be removed by surgery.~   "
231453|NCT00526877|"~     The purpose of this study is to evaluate the efficacy and safety of long-acting risperidone~     microspheres (small uniformly-sized spherical particles, of micrometer dimensions, frequently~     labeled with radioisotopes or various reagents acting as tags or markers) in participants~     with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment~     from reality, often with delusions and hallucinations, and withdrawal into the self) and~     schizoaffective disorders (a mixed psychiatric disorder relating to a complex psychotic state~     that has features of both schizophrenia and a mood disorder such as bipolar disorder), who~     are receiving psychiatric home-care treatment .~   "
231454|NCT00526864|"~     Total 7 institutions will be recruited i.e. Clinical Infectious Disease Research Unit~     Department of Clinical Tropical Medicine, Faculty of Tropical Medicine Mahidol~     University,Bamrasnaradura Infectious Disease Institute~      ,Pramonkutklao Hospital,Rajavithi Hospital,NationalCancerInstitute,Institute of~     Dermatology,Raj Pracha Samasai Institute~      OBJECTIVES~        -  Measure the burden of illness due to herpes zoster (Zoster) and post-herpetic neuralgia~          (PHN) (severity and duration);~        -  Assess the quality of life (QoL) and quality adjusted life years (QALY) lost due to~          Zoster and PHN;~        -  Describe health care resource utilization associated with Zoster and PHN;~        -  Describe the direct and indirect costs per case of Zoster and PHN~   "
231455|NCT00526851|"~     RATIONALE: Learning about oral cancer screening practices, knowledge, and opinions of Ohio~     nursing home dentists may help the study of oral cancer in the future.~      PURPOSE: This clinical trial is studying oral cancer screening among nursing home dentists in~     Ohio.~   "
231456|NCT00526838|"~     The purpose of this study is to assess the safety and tolerability of the multi-targeted~     protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as~     a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.~   "
231457|NCT00526812|"~     This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in~     recurrent high-grade gliomas.~   "
231458|NCT00526799|"~     This multi-institutional phase I/II clinical trial will test the tolerability and efficacy of~     the combination sorafenib and topotecan in patients with recurrent ovarian cancer, which is~     platinum-resistant (recurrence within 6 months from completing platinum based therapy) or~     refractory (progressive disease during platinum based therapy).~   "
231459|NCT00526786|"~     The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray~     Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD)~     within Barrett's Esophagus (BE).~   "
231460|NCT00526773|"~     To test the effectiveness of a motivational intervention compared with standard patient~     education in improving economic and clinical outcomes in patients enrolled in an existing~     heart failure (HF) disease management program.~   "
231461|NCT00526760|"~     Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who~     require more than 24 hours sedation.~   "
231462|NCT00526747|"~     Our goal of this pilot project is to identify inflammatory biomarkers that correlate with~     epo-resistance among CKD patients.~   "
231463|NCT00526734|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, use different ways to stop cancer~     cells from dividing so they stop growing or die. Stem cell transplant using stem cells from~     the patient may be able to replace immune cells that were destroyed by chemotherapy used to~     kill cancer cells. Giving colony-stimulating factors, such as G-CSF or pegfilgrastim, helps~     stem cells move from the bone marrow to the blood so they can be collected. It is not yet~     known which regimen is more effective in treating multiple myeloma.~      PURPOSE: This randomized phase II trial is studying how well high-dose chemotherapy followed~     by stem cell transplant works in treating patients with newly diagnosed stage I, stage II, or~     stage III multiple myeloma.~   "
231464|NCT00526721|"~     To evaluate achievement ratio of treatment target goal in hypercholesterolemia patients with~     high risk after high dose rosuvastatin(20mg/day) titration~   "
231465|NCT00526708|"~     To evaluate the efficacy of rosuvastatin in Korean dyslipidemia patients with hypertension.~   "
231466|NCT00526695|"~     Sevoflurane preconditioning and cardiovascular protection against ischemia/reperfusion~     injury.~      Study hypothesis: The volatile anesthetic sevoflurane at subanesthetic concentrations~     achieves endothelial protection against ischemia/reperfusion injury and reduces inflammatory~     markers in the circulation~   "
231467|NCT00526682|"~     Hypothesis: Cissus quadrangularis as well as Irvingia gabonensis are used in weight~     management and related conditions. This study set out to investigate if a combination of the~     two could have additional benefits to overweight and obese people.~   "
231468|NCT00526669|"~     The study will determine if changes in expression of markers involved in the 5-FU pathways~     are associated with response to treatment with the combination of lapatinib and capecitabine~     independent of tumor erbB2 status.~   "
231593|NCT00525005|"~     The purpose of this study is to determine the efficacy of combination of docetaxel,~     oxaliplatin, and S-1 (DOS) in the treatment of advanced gastric cancer.~   "
231469|NCT00526656|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in~     treating patients with locally advanced bladder cancer.~   "
231470|NCT00526643|"~     The primary objective of this study is to evaluate the impact on overall survival (OS) of the~     addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in~     poor clinical condition (PS 2), not previously treated.~   "
231471|NCT00526630|"~     The purpose of this research study is to examine whether Methylphenidate (MPD) can result in~     improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main~     disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate~     certain systems of the body that control motor function. This drug is FDA approved for the~     treatment of attention hyperactivity disorder, a condition unrelated to PD.~      The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will~     improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from~     treatment initiation in patients with moderately advanced PD, whose gait impairment is an~     important source of disability despite optimized antiparkinsonian treatment.~   "
231472|NCT00526617|"~     This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given~     together with Temozolomide (chemotherapy) in treating patients with solid tumors, including~     metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian~     tube cancer, and hepatocellular carcinoma (HCC).~   "
231473|NCT00526604|"~     Low back pain is a usual conditions in the western countries and several treatments available~     for patients with non-specific low back pain. According to the European guidelines are~     exercise and cognitive intervention effective on pain and function(www.backpaineurope.org),~     but it have no documented effect on return to work. In addition, there is no documentation~     that treatments which focus on a single treatment, is effective with regard to return to work~     for sick-listed patients.~      The challenges for health personnel is not cure of the patients back pain, but to build up~     rehabilitation programs which focus on disability and work incapacity, in patients which are~     at risk of loosing their work. Dr. P. Loisel, Montreal, Canada, has since 1995 treated~     patients with back pain according to the The PREVICAP model - (PREVention of work~     handICAP), where the main purpose with work-related program is to prevent prolonged~     disability and to help patients back to work. Loisel demonstrated that the PREVICAP models~     accelerated the return to work factor by a factor 2.4 (p=0.01). The PREVICAP model have~     also been evaluated in Amsterdam, by Dr. Anema with the same results.~      At the Back Clinic, Ullevål University Hospital we have evaluated several exercise programs~     with good effect on pain and function, but not on the return to work rate. We are planning to~     do a randomized controlled trial after the PREVICAP model. All included patients in both~     groups, will have an clinical examination by specialist in Physical Medicine and~     Rehabilitation and an exercise program. Patients will be randomized to a work-related~     rehabilitations program or to usual care by the general practitioner.~      Hypothesis Main hypothesis: Sick-listed patients with back pain, who will be randomized to~     the work-related rehabilitation programs, will return to work faster than patients randomized~     to usual care by the general practitioner.~      Second hypothesis: A cost-benefit analysis will favor the exercise program and work place~     intervention~   "
231474|NCT00526591|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving everolimus before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This randomized phase II trial is studying the side effects and how well everolimus~     works in treating patients with newly diagnosed localized prostate cancer.~   "
231475|NCT00526578|"~     The goal of this research study is to investigate the role of genes that may point to a~     higher risk of developing pancreatic cancer.~   "
231476|NCT00526565|"~     This randomized clinical trial evaluates the efficacy of TAT(Tapas Acupressure Technique)~     compared to a Social Support (SS) group for the primary outcome of weight loss maintenance.~     We recruit obese adults from the Kaiser Permanente Northwest managed care setting. Those who~     meet eligibility criteria are entered into an intensive six-month weekly group-based~     behavioral weight loss program. Those who meet threshold weight loss criteria (n=~288) are~     randomly assigned to either TAT instruction or social support group. Participants in both~     groups attend the same schedule of group meetings with parallel contact hours. Participants~     in the TAT group are advised to practice the technique at home. Participants are weighed and~     questionnaires administered at entry, randomization, and at 12 and 18 months post entry. The~     main outcome measure is weight at 18 months.~   "
231477|NCT00526552|"~     To evaluate the efficacy of rosuvastatin in Korean dyslipidemia patients with diabetes~   "
231478|NCT00526539|"~     Total hip replacement is a very cost effective procedure to enhance life quality in a group~     of patients. In the period 2000-2004 7-8000 procedures were preformed, 13% were revisions~     (1). Historically, many different principles have been used from the first resurfacings to~     cemented and uncemented total hip replacements as we know them today. In 2000, 28 different~     femoral stems and 26 different acetabular components were in regular use in Norway. There are~     several well-documented cemented acetabular components, but no such uncemented cup. On the~     femoral side there are several well-documented stems both cemented and uncemented. (2).~      From the late 1990`s a reverse hybrid (uncemented stem and cemented cup) is being more~     frequently used. In 2004 a total of 276 reverse hybrid hips were done and the trend is~     increasing. (1). This technique is solely based on experience and the fact that one combines~     the better of two principles (cemented and uncemented). There is no scientific evidence that~     this technique is as good or better than a cemented THR.~      One of the potential problems with hydroxyapatite coated components is that it is suspected~     that it may increase wear due to the particle theory. (3,4). There are no prospective~     randomised controlled RSA and DXA studies that conclude on this matter. This is such a study~     and our hypothesis is that there is no difference in wear or osteolysis between the methods.~   "
231479|NCT00526513|"~     Primary Objectives:~      To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG & PPBG) from~     baseline to the end of the study.~      Secondary Objectives:~      To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the~     incidence of hypoglycemia and other adverse events.~   "
231480|NCT00526500|"~     The aim of this study is to determine effect of proprioceptive stimulation with passive gait~     training on the cortical activity in patients with severe brain injury, demonstrated as~     changes in EEG (electroencephalogram)and ERP (Event Related Potentials).~      Hypotheses: 1) Proprioceptive stimulation increases EEG-frequency in patients with impaired~     consciousness due to severe brain injury.~      2) Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of~     ERP in patients with impaired consciousness due to severe brain injury.~   "
231482|NCT00526474|"~     The study is designed to determine whether vorapaxar, when added to the existing standard of~     care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants~     with a known history of atherosclerosis, will yield additional benefit over the existing~     standard of care without vorapaxar in preventing heart attack and stroke.~      The study is also designed to assess risk of bleeding with vorapaxar added to the standard of~     care versus the standard of care alone.~   "
231483|NCT00526461|"~     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells.~     The drug becomes active when it is exposed to a certain kind of light. When the drug is~     active, tumor cells are killed.~      PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic~     therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.~   "
231484|NCT00526448|"~     To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C~     virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients~     genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week~     and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body~     weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day,~     according to body weight).~      To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to~     week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR~     = RNA - HCV undetectable at 4 week).~   "
231485|NCT00526435|"~     The overall goal of this study is to determine the whether the Walk with Ease (WWE) program~     in its 2 version (group-assisted and self-directed) can increase physical activity and~     fitness levels among individuals (18 years and older) with arthritis over the long-term.~     Participants will be approximately 657 subjects from 20-24 rural and urban communities across~     North Carolina. It is expected that participants in the WWE program will have reduced pain,~     improved function and increased activity levels after participation in this 6-week program.~   "
231486|NCT00526422|"~     The purpose of this study was to determine what methods Dental PBRN dentists use for~     diagnosis, prevention, and treatment of dental decay.~   "
231487|NCT00526409|"~     The study objective is to improve the global results obtained with LAL-AR-93 study, reaching~     an event free survival between 60-70%.~      Identify patients with bad prognosis, with minimal residual disease,who can benefit of~     allogenic bone marrow transplantation~   "
231488|NCT00526396|"~     The purpose of this study is to compare the activity of fixed doses of cisplatin and~     etoposide with toxicity adjusted dosing of the same drugs in the first-line treatment of~     small cell lung cancer.~   "
231489|NCT00526383|"~     Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1~     antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes~     is a matter of concern.~      The main objective of this study is to assess the differential impact of antidepressants in~     terms of weight gain and metabolic syndromes.~   "
231490|NCT00526370|"~     The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare~     with the cytological and histological diagnoses.~      Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable~     alternative to the routine cervical smear.~   "
231491|NCT00526357|"~     We wish to investigate the effects of 3 weeks of orally administered fish oil supplements on~     the airway sensitivity (provoking dose to cause a 15% fall in FEV1, PD15) to inhaled mannitol~     (AridolTM). Mannitol, an osmotic stimulus has been demonstrated as a useful model for~     exercise-induced asthma. We also wish to investigate if there is any associated improvement~     associated with selected markers of airway inflammation that can be measured in the sputum,~     blood, urine and exhaled breath condensate. Oral fish oil supplements have recently been~     demonstrated to be effective inhibitors of exercise-induced asthma, in association with an~     inhibition of markers of inflammation, over a 3 week treatment period. This finding has~     important implications in the treatment of asthma as this is a faster and more effective~     improvement than what is seen with inhaled corticosteroids on exercise-induced asthma. This~     observation requires validation and further investigation. We wish to study this in two~     patient groups; (a) steroid naïve asthmatics taking beta2 agonist when required and (b)~     asthmatics taking regular inhaled corticosteroids < 1000 mcg/day.~   "
231492|NCT00526344|"~     This study aims at determining the patterns of asthma remission, the prevalence of these~     different patterns and the various factors associated with such remissions and possible~     recurrences of asthma, in order to determine the mechanisms involved in these processes.~      We therefore want to document these specificities in studying biopsies of subjects in~     complete remission of their asthma and those in only symptomatic remission of their asthma,~     in comparison with mildly symptomatic asthmatic subjects and healthy controls.~   "
231493|NCT00526331|"~     The purpose of this study is to determine whether the early identification and more precise~     intervention of operating room (OR) patient fluid administration optimization using arterial~     pressure-based cardiac output (APCO) yields comparable patient outcome as fluid~     administration optimization using a global standard care method.~   "
231494|NCT00526318|"~     RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of~     tumor cells by stopping them from dividing or by killing them. It also prepares the patient's~     bone marrow for the stem cell transplant. The stem cells are given to the patient to replace~     the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after~     transplant may kill any remaining tumor cells. It is not yet known which combination~     chemotherapy regimen is more effective when given before a stem cell transplant and~     isotretinoin in treating neuroblastoma.~      PURPOSE: This randomized clinical trial is studying two different combination chemotherapy~     regimens to compare how well they work when given before a stem cell transplant and~     isotretinoin in treating young patients with high-risk neuroblastoma.~   "
231495|NCT00526305|"~     Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical~     protocol with: intensification treatment of induction to increment the CR rate, allogenic~     transplantation in first CR, autologous transplantation follow by alfa interferon in patients~     cannot done allogenic transplantation.~   "
231651|NCT00524238|"~     Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with~     fatigue one of the main symptoms is weight gain as a result to significantly decreased energy~     expenditure.~      This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in~     these patients.~   "
231496|NCT00526292|"~     The goal of this study is to see if there is a benefit to giving chemotherapy and then~     natural killer (NK) cells. The NK cells must come from a family member who shares half of the~     patients HLA proteins. NK cells are a type of white blood cell. They can recognize and kill~     abnormal cells in the body.~      Patients whose blood cancer is not cured with a stem cell transplant do not have standard~     treatment options. Studies have shown that NK cells from a donor can be given safely and can~     be helpful in treating some blood diseases. These NK cells are collected from the patients~     donor and purified using a separation system called CliniMACS that has been used safely in~     previous studies and is used in this study with the approval of the Federal Food and Drug~     Administration. The researchers want to find out what effects the NK cells will have on blood~     cancer and bone marrow function and how to maximize its benefits in treating blood cancers.~     The researchers hope that giving chemotherapy and then NK cells will be a better treatment~     for the disease than the current available treatment options.~      Funding Source - Food and Drug Administration/Office of Orphan Products Development~   "
231497|NCT00526279|"~     To evaluate compliance and patients' satisfaction in mono and combination treatment of~     Candesartan cilexetil (Atacand)/ Candesartan cilexetil 16mg, hydrochlorothiazide 12.5mg~     (Atacand plus) in hypertension.~   "
231498|NCT00526266|"~     The purpose of the study is to determine if a physiological marker, joint rotation of the~     upper body, can be affected by the release of emotional trauma during a brief~     psychotherapeutic encounter, and whether acupressure is an active ingredient in EFT.~   "
231499|NCT00526253|"~     This study injects a person's own stem cells into heart muscle tissue after a person has one~     or more heart attacks. The purpose of the study is whether the stem cells will improve a~     patient's heart performance.~   "
231500|NCT00526227|"~     The purpose of the Secura clinical study is to evaluate the overall system safety and~     clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)~   "
231501|NCT00526214|"~     Primary:~      Change of volume of perihematomal edema as assessed by brain CT.~      Secondary:~      The change of ICH volume between the initial and the follow-up CT scans The neurological~     status at 90 day using E-GOS and mRS. The cumulative incidence of major and minor adverse~     events that occurred during and after hospitalization until the end of the study~   "
231502|NCT00526201|"~     The purpose of this project is to determine if an evidence-based, community-delivered~     physical activity program, EnhanceFitness, yields benefits for participants with arthritis.~     The 3-year project will: 1) conduct a meta-analysis of community-based exercise programs for~     adults, 2) implement and evaluate the EnhanceFitness program in West Virginia using a~     randomized, controlled (wait list) design, and 3) disseminate the results to community and~     public health partners. It is anticipated that participation in the EnhanceFitness program~     will result in reduced pain, improved physical function and physical activity levels for~     adults with arthritis.~   "
231503|NCT00526188|"~     Participants who had been diagnosed or suspected by doctors to have focal liver lesions that~     need further evaluation in order to make an accurate diagnosis. Participants would need to~     have an enhanced magnetic resonance imaging (MRI) scan so that doctors could have further~     information about the number and characteristics of the focal liver lesions.~      Participants were invited to take part in this clinical study. The purpose of this study was~     to evaluate Primovist, which is a liver-specific MRI contrast medium, on the efficacy of~     lesion detection and characterization, and tolerability in Chinese patients with known or~     suspected focal liver lesions.~      Primovist, the investigational drug in this study, is a liver-specific MRI contrast medium~     developed by Bayer Schering Pharma AG. Its active substance is Gd-EOB-DTPA. Primovist was~     first approved in 2004 in Sweden followed by an approval in the European community, in~     Switzerland and Australia in the same year.~      Procedures:~      Before entry into the study and after entry of the study a physical examination was~     conducted, blood pressure and heart rate were measured, blood and urine samples were taken.~     Current medications and medical conditions (including suspected pregnancy) and medical and~     surgical history were elicited by doctors.~      After entry into the study, participants were scheduled to have an MRI examination, which~     lasted about 25-35 minutes.~      During the MRI examination, an initial MRI scan without contrast was acquired which followed~     by another MRI series after the intravenous administration of Primovist.~      The following day participants were asked to return to the hospital for a follow-up safety~     evaluation.~      Possible Benefit Participants were scheduled to receive an enhanced magnetic resonance~     imaging scan. Clinical studies indicated that Primovist increased the efficacy of detection~     and characterization of focal liver lesions by providing better contrast between the focal~     liver lesions and surrounding normal tissue. Primovist were shown to provide additional~     information regarding existence, number and characterization (lesion or non-lesion, malignant~     or benign) of these abnormalities.~      Based on the experience with patients given Primovist, some adverse reactions were observed.~      Most of undesirable effects were transient and of mild to moderate intensity. The most~     commonly noted adverse events (AEs) in subjects receiving Primovist for MRI were nausea and~     headache with an incidence of 1.1%. Other AEs that occurred in 0.5% of the subject population~     were feeling hot (0.8%), back pain (0.6%) and dizziness (0.5%).~      All other AEs occurred in less than 0.5% of the patients, e.g. anxiety; coughing; eye~     disorder; fever; flatulence; generalized spasm; hypertension; injection site symptoms~     including edema, inflammation, and reaction; lightheadedness; parosmia; postural hypotension;~     taste perversion, motoric unrest; acute respiratory distress; fatigue; malaise; vomiting;~     palpitations, erythema, chest pain and back pain.~      Coldness, warmth or pain at the injection site, injection site reaction, and injection site~     accumulation of fluid were rare. In very rare cases strong allergy-like reactions ranging to~     shock may occur.~      Post-marketing tachycardia and restlessness have been reported. As in the case of other~     investigational drugs, there may also be unforeseen side effects.~      Additional information concerning all Gadolinium- based contrast agents Primovist contains~     the rare earth metal gadolinium as active ingredient. There have been reports of nephrogenic~     systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents~     (especially Omniscan) in patients with severe renal impairment. NSF is a systemic disease~     characterised by formation of connective tissue in the skin, which becomes thickened and~     hard, sometimes leading to contractures and joint immobility. The clinical course is usually~     progressive and currently no treatment is available. To date NSF has only been reported in~     association with some Gd-containing contrast agents, but the role of these contrast agents in~     the overall pathogenesis of the disease is still not completely understood.~      No reports of patients with NSF after administration of Primovist® are known. The risk to~     trigger NSF in risk patients with severe renal impairment is considered to be low for~     Primovist® due to the low dose given and the additional excretion via feces. Furthermore the~     participation of patients with severe renal impairment are excluded from this study.~      In case the participants were suffering from renal insufficiency, they were told to tell~     their doctors prior to application of the contrast agent. In case the participants~     experienced any new alterations of the skin following the administration of the contrast~     agent, they were told to contact their doctors as soon as possible after they had recognized~     these symptoms.~   "
231504|NCT00526175|"~     The purpose of this study is increase the efficacy of consolidation (C1) after an~     intensification phase with high dose of methotrexate, applying analysis of minimal residual~     disease~   "
231505|NCT00526162|"~     The purpose of the Consulta clinical study is to evaluate the overall system safety and~     clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac~     Resynchronization Therapy (CRT-D).~   "
231506|NCT00526149|"~     RATIONALE: BI 2536 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase II trial is studying the side effects and how well BI 2536 works in~     treating patients with recurrent or metastatic solid tumors.~   "
231507|NCT00526136|"~     To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg,~     300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained~     symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).~   "
231508|NCT00526123|"~     The purpose of this clinical trial is to compare the longevity of two dialysis catheters.~   "
231509|NCT00526110|"~     Phase I Objectives~      Primary:~      1. The primary objective of this study is to determine the maximum tolerated dose (MTD) of~     Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated,~     locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction~     (GEJ).~      Secondary:~      1. To determine the qualitative and quantitative toxicity and reversibility of toxicity of~     this combination.~      Phase II Objectives~      Primary:~      1. To assess time to cancer progression to D-FOX treatment regimen.~      Secondary:~        1. To assess response rate to D-FOX treatment regimen.~        2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of~          this combination treatment regimen.~        3. Determine overall survival.~        4. Perform an exploratory investigation into the effect of D-FOX on phenotypic~          abnormalities in blood.~   "
231510|NCT00526097|"~     The objective of the study was to compare the efficacy and safety of 4 weeks treatment with~     bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In~     addition, the effect of treatment on quality of life and general health status was evaluated.~   "
231522|NCT00525941|"~     NBI-34060 is an investigational (research) medication being studied in people with insomnia.~     The current study is designed to evaluate how people, who experience a nighttime awakening~     with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The~     study will also examine the pattern and extent of nighttime awakenings as reported by the~     patients, as well as and the patient's sleep experience during treatment.~   "
231523|NCT00525928|"~     This study of psychiatric inpatients will assess mood effects of varenicline, as well as~     assess if varenicline decreased nicotine cravings acutely.~      This study will also measure side effects of varenicline when given in addition to other~     psychiatric and non-psychiatric medications.~   "
231536|NCT00525759|"~     There is clear preclinical in vitro and in vivo evidence of sequence dependent synergy~     between chemotherapy agents and zoledronic acid. The aim of the study is to investigate if~     the synergistic increase in tumour cell apoptosis observed in preclinical studies occurs in~     patients. The hypothesis for this study is that there may be anti-tumour benefits of the~     sequential application of chemotherapy agents followed by zoledronic acid in patients with~     invasive breast cancer.~   "
231511|NCT00526084|"~     Emerging results suggest that a cure rate of nearly 90 percent will be attained in the near~     future. The advance was attributed to stringent application of prognostic factors for risk~     factor-directed therapy. Early response to treatment has greater prognostic strength than~     does any other biologic or clinical feature tested to dates. The measurement of minimal~     residual disease(MRD) affords a level of sensitivity and specificity that cannot be attained~     through traditional microscopic morphologic assessments. In Taiwan, detection for the most~     recurrent fusion genes and the MRD were not commonly available, the TPOG(Taiwan Pediatric~     Oncology Group) used clinical features, immunophenotypes, and cytogenetics to do risk group~     classifications and protocol assignment. A successful rate of 60-70% has been reached. In~     order to improve the cure rate of ALL in Taiwan, this project aims at establishing the~     methods for better risk classifications and establishing MRD detection for risk-directed~     therapy for childhood ALL in Taiwan.Intrinsic and acquired resistances to multiple anticancer~     agents represent major obstacles and accounts for 10-20% of treatment failure in the~     developed countries nowadays. Recent progress using DNA microarray identified differential~     expression level of the genes known to implicate in cell cycle control, DNA repair and~     apoptosis in different subsets of ALL patients, which were found to be related to drug~     response. Genetic polymorphisms in the genes of drug-metabolizing enzymes, drug transporters~     or drug targets, can influence the efficacy or toxicity of antileukemic agents. Specific~     genotype might be important in determining the pharmacokinetic effects of one population or~     disease subtype from that in others. Recently, the expression profiles of relatively few~     microRNAs (miRNAs) (~200 genes), was noted to accurately classify human cancers. These~     informations hinted that expression of the genes in the leukemic cells might serve as~     additional risk factors for treatment stratification.~      Specific aims and goals:~        1. to establish better risk factors classification and use MRD to monitor early response to~          treatment.~        2. to establish the expression profiles of 12 genes associated with drug resistance~        3. to unravel the pharmacogenetic background of pediatric ALL in Taiwan, so that will help~          refine the therapy dose, achieve a better drug effect and avoid acute or chronic~          toxicity.~        4. microRNA expression profiles in childhood ALL in Taiwan~   "
231512|NCT00526071|"~     This is a long term open label study of AT1001 in patients with Fabry disease previously~     enrolled in a Phase 2 AT1001 trial.~   "
231513|NCT00526058|"~     The primary objective of the study is to demonstrate that the performance of the modified~     Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved~     Plasmat® Secura H.E.L.P Apheresis System for use under the approved indication of the acute~     reduction of LDL-cholesterol from the plasma in populations for whom diet has been~     ineffective and maximum drug therapy has either been ineffective or not tolerated.~   "
231514|NCT00526045|"~     This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in~     patients with advanced solid malignancies to determine the maximum tolerated dose. Phase II~     expansion arms will investigate efficacy in patients with either HER2 positive or ER positive~     locally advanced or metastatic breast cancer. Additional patients with advanced solid~     malignancies will also be investigated in a separate expansion arm. Safety, pharmacokinetics~     and pharmacodynamics will be assessed.~   "
231515|NCT00526032|"~     Primary Objectives:~        -  To establish a statistically significant database: With Spectroscopic Oblique-Incidence~          Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of~          1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical~          diagnosis, are routinely biopsied and submitted for histopathologic diagnosis and of the~          adjacent normal skin for self-referencing. The experimental database will contain~          demographic information, clinical diagnoses, clinical images, OIR images,~          histopathologic diagnoses, and morphometric data on the lesions.~        -  To develop and validate a diagnostic algorithm:~             1. Classification: A subset (~50%) of OIR images collected will be used to complete~               the development of state-of-the-art image processing algorithms to extract robustly~               effective diagnostic features.~             2. Blind Testing and Evaluation: The algorithms established will be evaluated and~               validated in a prospective blind-test fashion using the complementary subset of the~               database that was not involved in designing the classifier. The sensitivity and~               specificity of the classification system will be evaluated based on the~               receiver-operating-characteristic (ROC) curve.~        -  To identify the pathophysiologic parameters responsible for the diagnostic optical~          features: The anatomic and physiologic sources of the diagnostic optical signatures will~          be identified by comparative analyses using the OIR images, microscopic~          histomorphometric techniques and theoretical modeling to test the following hypotheses:~             1. The calculated differences in hemoglobin oxygen saturation.~             2. Comparisons of the calculated size distributions of skin scattering centers with~               histologic and morphometric analyses of various cellular and tissue components of~               the skin lesions.~             3. The relative densities and distributions of the different anatomic and physiologic~               diagnostic features within the interrogation volumes are important diagnostic~               factors in OIR.~   "
231516|NCT00526019|"~     This study aims at determining the patterns of asthma remission, the prevalence of these~     different patterns, the various factors associated with such remissions and possible~     recurrences of asthma, in order to determine the mechanisms involved in these processes.~      The investigators therefore want to document these specificities in subjects in complete~     remission of their asthma, and those in only symptomatic remission of their asthma, in~     comparison with mildly symptomatic asthmatic subjects and healthy controls.~   "
231517|NCT00526006|"~     The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of~     treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is~     of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers~     are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are~     scored once a week and.~   "
231518|NCT00525993|"~     The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be~     non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in~     sports. The investigators objective is to discuss the point that the investigators will~     follow the minimal dose that is effective for the treatment of this acute condition in~     orthopedic.~   "
231519|NCT00525980|"~     This project will build upon prior, successful research on the effectiveness of an~     interactive computer disk with readable only memory (CD-ROM) for educating women about breast~     cancer and genetic risk. Prior studies found that an interactive CD-ROM for educating women~     about breast cancer risk and genetic testing was effective. The program was well received by~     lay persons and professionals. In a randomized controlled trial conducted at multiple sites,~     the CD-ROM intervention was highly effective in increasing knowledge, especially among women~     at low risk of carrying a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation.~      Researchers now propose to expand the use of the interactive CD-ROM in two innovative ways.~     The overall goal of this proposal is to evaluate the program as a first-line educational~     approach for Hispanic women on the Texas-Mexico border, where educational resources about~     cancer genetics are limited. First, researchers will modify and adapt the program for a~     primarily Hispanic population, in order to make it culturally and linguistically appropriate~     to the needs of that audience.~      Second, researchers will evaluate the program as a first-line educational method among women~     with a personal or family history of breast cancer. Researchers will compare the~     effectiveness of the CD-ROM when implemented with and without the guidance of a trained~     promotora, and in comparison with standard educational materials (usual care condition).~      The specific aims of this study include:~      Aim 1: To modify the interactive CD-ROM to: a) make it culturally and linguistically~     appropriate for Hispanic women residing along the Texas-Mexico border; b) reflect current~     knowledge about breast cancer genetics; c) add a module to help women prepare to discuss~     their family history and cancer risk with a health care provider (n=50 participants).~      Aim 2: To conduct a randomized, controlled evaluation that compares the efficacy of the~     modified CD-ROM when used alone vs. when used with a promotora-assisted approach vs. standard~     written materials (n=414 participants).~   "
231520|NCT00525967|"~     The purpose of this study is to determine whether oral methadone plus acetaminophen can~     substitute morphine in the treatment of cancer pain.~   "
231521|NCT00525954|"~     The study will be conducted at up to 25 U.S. centers and will be a double-blind randomized~     parallel group placebo controlled study among subjects with stable coronary artery disease~     (CAD). Subjects will be randomized to receive either placebo tablets or one of 2 orally~     active doses of A-002. The duration of study drug therapy will be 8 weeks.~   "
231524|NCT00525915|"~     The goal of this clinical research study is to learn if a combination of the investigational~     drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is~     as effective as a combination of these two drugs given before and during radiation therapy in~     the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of~     therapy will also be compared.~      Objectives:~      Primary objective:~      Compare the Pathologic Complete Response rate and % of patients with <50% residual cancer in~     the resected surgical specimen between Arms A and B.~      Secondary objectives:~        1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates,~          safety, and local plus systemic relapse rates between Arms A and B~        2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to~          assess predictive markers of response and outcome.~        3. Evaluate the joint effects, including possible interactive effects, of~          proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates,~          safety, and local plus systemic relapse rates.~   "
231525|NCT00525902|"~     The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.~   "
231526|NCT00525889|"~     This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within~     the previous 3-48 months. The study is testing whether two immune system modifying drugs are~     safe when used in combination and if they have immune altering effects that indicate they can~     halt the progression of type 1 diabetes progression.~   "
231527|NCT00525876|"~     1. To determine the safety and efficacy of non-myeloablative allogeneic stem cell~          transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen~          for patients with advanced or recurrent mantle cell lymphoma.~        2. To determine factors associated with response and durable remission in patients~          receiving rituximab, cyclophosphamide, and fludarabine in preparation for allogeneic~          stem cell transplantation.~   "
231528|NCT00525863|"~     Due to intense ATP-consuming processes in the brain, a high level of brain energy supply is~     required. A popular hypothesis regarding the pathogenesis and pathophysiology of~     schizophrenia postulates hypofunction of neuronal circuits in the prefrontal and~     limbic-temporal areas. An emerging body of data suggests that impaired energy metabolism due~     to mitochondrial dysfunction plays a role in the pathophysiology of schizophrenia.~      Under normal conditions cellular metabolic rate, i.e. oxygen and glucose consumption,~     increases proportionally with any increase in neuronal activity. The impaired energy~     metabolism due to mitochondrial dysfunction and frontal lobe hypofunction might be improved~     by increasing O2 supply to the brain. Oxygen-enriched air inhalation has been shown to~     increase brain oxygen supply. Hyperoxia therapy is a useful tool in the treatment of~     neurological and neurotrauma deficits.~      We therefore suggest a randomized double blind cross-over study of enriched inspired O2~     partial pressure in schizophrenia.~      It is surprising given the numerous findings on reduced energy metabolism in schizophrenia~     that simple treatment with inspired enriched oxygen has not been studied.~   "
231529|NCT00525850|"~     To evaluate two different diets and their effects on weight loss and measurements of several~     risk factors for cardiovascular disease. One diet will be a high saturated fat diet (HSFD)~     and the other is a low saturated fat diet (LSFD) that limits fat but especially saturated fat~     as red meat. All participants in this study must eat both diets as this is a randomized~     cross-over design.~   "
231530|NCT00525837|"~     This study will assess whether varenicline (chantix) has antidepressant properties when used~     in addition to other psychiatric medication. It will also assess whether varenicline improves~     the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with~     psychiatric medications.~      Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of~     health, side effects as well as tobacco use for 6-8 weeks.~      Medication will be provided free of charge.~   "
231531|NCT00525824|"~     The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or~     Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low~     Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary~     Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20%~   "
231532|NCT00525811|"~     Shared decision making (SDM) has been advocated as an appropriate approach for physician~     patient communication. Positive effects of SDM are e.g higher patient satisfaction, greater~     treatment adherence, lower decisional conflict and better clinical outcomes. The Section of~     Clinical Epidemiology and Health Services Research at the University Medical Center in~     Freiburg (Germany) is developing and evaluating a web-based interactive decision aid~     (patient dialogue) to support shared decision making in cooperation with the Techniker~     Krankenkasse, a large German health insurance company. Both development and evaluation are~     conducted along the International Patient Decision Aid Standards (IPDAS).~      The decision aid contains information on acute low back pain and depression and addresses~     insurance members who are facing a treatment decision in one of the indications. It aims at~     the development of patient competencies for participating in decision making, the support of~     constructive health behavior and patients' acceptance of evidence based treatment options.~      In an RCT the decision aid will be compared to a regular patient information on a sample of~     N=500 patients in each group. Data collection will take place at three points of time: before~     and after use of the decision aid as well as 3 months later.~   "
231533|NCT00525798|"~     The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon~     calcitonin in the treatment of patients with osteoporosis~   "
231534|NCT00525785|"~     The goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid~     and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or~     gastroesophageal cancers that will be removed by surgery if possible. The safety of this~     combination therapy will also be studied.~   "
231535|NCT00525772|"~     The purpose of this study is to study the effects of once daily inhaled ciclesonide at~     varying doses on exercise provoked asthma symptoms, fall in lung function after exercise and~     sputum characteristics.~   "
231537|NCT00525746|"~     The goal of this research study is to identify biologic and lifestyle factors that may~     increase a person's risk of developing acute myeloid leukemia or myelodysplastic syndrome~     after treatment for a previous cancer (treatment-related AML/MDS).~   "
231538|NCT00525733|"~     The researchers are involved in a phase II, randomized, two-arm study, comparing the~     efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with~     Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and~     raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women.~     Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the~     investigator and patient that continued therapy is in the patient's best interest.~      Hypotheses:~        -  Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination~          with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral~          replication.~        -  Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect~          to immune reconstitution in peripheral blood and in the gastrointestinal mucosa.~        -  Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with~          respect to tolerability.~   "
231539|NCT00525720|"~     The goal of this clinical research study is to learn if a prostate implant (brachytherapy)~     can help to control intermediate risk prostate cancer. The safety of this procedure will also~     be studied.~      Prostate brachytherapy is performed by inserting permanent seeds (which are radioactive~     pellets) into your prostate in order to treat the prostate cancer with radiation therapy.~   "
231540|NCT00525707|"~     The randomized patients with acute heart failure will be stratified based on the presence or~     absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the~     first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of~     the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days~     after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up~     period of 5 months for vital status.~   "
231541|NCT00525694|"~     This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor~     added to a zero calorie product might be important to consider in the management of obesity,~     metabolic syndrome and diabetes mellitus. This research trial will evaluate the effect of~     three different solutions on blood glucose level. One solution is plain water, the second a~     standard high glucose (sugar) solution used typically in diabetes testing, and the third a~     low calorie drink (Zero Coke). Based on a prior study evaluating a diet for effective weight~     loss, we observed that patients who drank large volumes of diet soda did not lose weight as~     readily as those who did not drink diet soda. Therefore, we propose to examine the actual~     effect of one diet soda (Zero Coke) on the body's glucose level and compare it to water and a~     high glucose solution. All participants in this study must have 3 Glucose tolerance~     evaluations - one with each solution: water, high glucose, and Zero Coke.~   "
231542|NCT00525681|"~     The major cause of premature death in renal transplant recipients is cardio-vascular disease.~     In addition, obesity is becoming a major problem in this patient population. Rimonabant does~     not only seem to have weight reducing properties but also weight reduction independent~     effects on insulin sensitivity and endothelial function, two important cardio-vascular risk~     factors. Rimonabant therefore is an interesting drug for the treatment of transplanted~     patients. Present data also indicate that rimonabant does not interact with essential~     immunosuppressive drugs (CsA and Tac) indicating that it most probably is safe to administer~     to this patient population. However this needs to be investigated in a proper manner.~   "
231543|NCT00525668|"~     Hypothesis:~      Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a~     period of 18 months has anti-inflammatory and neuroprotective properties in patients with~     relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical~     examination (EDSS and MSFC).~   "
231544|NCT00525655|"~     The goal of this research study is to test the first version of a website that will offer~     information and support for adolescents and young adults with FAP. Researchers want to see if~     the website will be helpful, easy to understand, and easy to use for young patients with FAP.~   "
231545|NCT00525642|"~     Anthracycline based regimens followed by a taxane (CALGB-9344 trial and NSABP-B28) or~     reversed (MD Anderson Adjuvant Trial) has already accepted as adjuvant therapy for node~     positive breast cancer. Also in this group of patients, data from BCIRG-001 trial had shown~     that six cycles of adjuvant TAC (docetaxel, doxorubicin and cyclophosphamide) is superior to~     standard FAC (5-FU, doxorubicin and cyclophosphamide ) combination in terms of both disease~     free and overall survival, while associated with a higher rate of febrile neutropenia. Then~     question arose whether it is better to use docetaxel and anthracycline in combination or~     sequence.~   "
231546|NCT00525629|"~     Walnuts include many potentially beneficial micronutrients and phytochemicals, in this study~     we propose to examine the effects of walnuts independent of macronutrient content. The~     purpose of this proposal is to study in depth the short-term effects of walnut consumption in~     men and women with the metabolic syndrome.~      Study Aim 1: To investigate the effects of walnuts (48gms per day over 3 days) on insulin~     resistance in subjects with the metabolic syndrome.~      Study Aim 2: To investigate the effects of 48gms per day of walnuts over 3 days on lipids and~     inflammatory markers.~      Study Aim 3: To assess the possible mechanisms of the biological effects of short-term walnut~     consumption through assessment of adipokines, resting metabolic rate, gene expression in~     white blood cells and the effect of walnuts when consumed as part of a mixed meal, on glucose~     excursions, insulin secretion and the excretion of gut peptides and free fatty acids.~   "
231547|NCT00525616|"~     The aim of the study is to assess that it will be possible to control with a single cycle of~     rituximab patient with bullous pemphigoid.~   "
231548|NCT00525603|"~     Primary Objective:~      1. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR)~     to increase the proportion of patients with <5% CD5/CD19+ cells in bone marrow to 66%~     following 3 courses of treatment without significantly increasing the incidence of pneumonia~     or sepsis compared to a historic group of patients treated with the combination fludarabine,~     cyclophosphamide, and rituximab (FCR).~      Second Objectives:~        1. Assess complete remission (CR), nodular partial remission (nPR), and partial remission~          (PR) rates (overall response) in high-risk, previously untreated patients with CLL~          treated with CFAR.~        2. Evaluate molecular remission in bone marrow by polymerase chain reaction (PCR) for the~          clonal immunoglobulin heavy chain variable gene in responders treated with CFAR.~        3. Assess immune parameters including blood T cell counts and subset distribution and serum~          immunoglobulin levels pretreatment, during treatment, and post-treatment in patients~          treated with CFAR.~   "
231552|NCT00525551|"~     In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds~     cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is~     usually treated by an operation where the bone is replaced by a prosthesis. This restores~     hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller~     effect at high frequencies is probably caused by surgically induced inner ear damage.~      Animal studies have shown that the drug acetylcysteine can protect the inner ear against~     damage. It is not known whether the drug has similar effects in humans. This study will~     assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.~   "
231553|NCT00525538|"~     The purpose of this study is comparision conformal radiotherapy for gynecologic cancer~   "
231554|NCT00525525|"~     This is a phase II study of Bevacizumab plus Temodar and Tarceva in patients with~     non-progressive glioblastoma or gliosarcoma. Patients must have stable disease immediately~     following a standard course of up-front radiotherapy and Temodar. All patients will receive~     Bevacizumab, Temodar and Tarceva. A total of 60 patients will be enrolled. Our hypothesis is~     that the combination of Bevacizumab plus Temodar and Tarceva will increase survival over that~     seen in historical controls who have newly diagnosed, non-progressive glioblastoma or~     gliosarcoma following radiotherapy plus Temodar and use Temodar alone.~   "
231555|NCT00525512|"~     The objective of this study is to evaluate the effects on exercise duration of 96 weeks~     treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in~     patients with COPD.~   "
231556|NCT00525499|"~     The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating~     acne.~   "
231557|NCT00525486|"~     To evaluate the treatment efficacy and safety usig extended release nifedipine, as~     maintenance therapy to pregnant women who were hospitalized and treated for preterm labor~     until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the~     treatment group and the control (no treatment) group.~      The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome~     will be the side effects of the medication and the newborn/mother health variables.~   "
231558|NCT00525473|"~     Azathioprine (AZA) has long been used in dermatology in treating autoimmune bullous~     dermatoses and generalized eczematous disorders as well as some photodermatoses. Its~     metabolic process inside human body and its side effects relies on genetic polymorphism of~     some enzymes such as thiopurine s-methyltransferase (TPMT) and inosine triphosphate~     pyrophosphatase gene (ITPA). This study aims to analyze the relative contribution of TMPT and~     ITPA mutations to the development of toxicity induced by AZA treatment and to detect the~     correlation of the genetic polymorphism.~   "
231559|NCT00525460|"~     The purpose of this study is to ask youn women diagnosed with ovarian cancer who have~     undergone surgery that will allow them to have children in the future, on issues such as:~     education about their options to keep their ability to have children, after-chemotherapy~     treatment decision making, and reproductive history. The second purpose is to determine the~     effect of an early diagnosis of ovarian cancer on the sexual functioning of women.~   "
231560|NCT00525447|"~     This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a~     regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with~     relapsed multiple myeloma.~   "
231561|NCT00525434|"~     The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB~     system for excisional biopsy wounds closure~   "
231562|NCT00525421|"~     A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of~     curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with~     OLP presenting to the oral medicine clinic at the University of California, San Francisco,~     will be enrolled. Study subjects will be randomized to receive either placebo or curcuminoids~     6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. Measurement of~     signs, symptoms, periodontal status and blood tests including complete blood count, liver~     enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and~     at the end of 2 weeks. A side-effects questionnaire will be administered at the 2-week~     follow-up.~      The Numeric Rating Scale (NRS) will be used to measure symptoms and the Modified Oral~     Mucositis Index (MOMI) to measure clinical signs of OLP. Primary outcome is change in~     symptoms from baseline. Secondary outcomes are change in clinical signs, occurrence of~     side-effects, change in serum C-reactive protein and serum interleukin-6 levels.~   "
231563|NCT00525408|"~     This study proposed the comparison the overall survival, hematological toxicity, pain~     reduction score,PSA levels, tumor response, quality of life in two arms of HRPC patients from~     different parts of India.~   "
231564|NCT00525395|"~     Background~      Phototherapy UVB TL01 currently represents the first choice in treatment to induce the~     repigmentation of vitiligo spots. The problem though is that there are no systems or scales~     which enable an objective evaluation of the therapy, commonly known as percentage of~     repigmentation.~      Recently, a European Task Force (VETF, Vitiligo European Task Force) of experts on vitiligo,~     within the European Society of Pigmentation, has proposed a gravity classification on the~     basis of three parameters/standards - extension, progression and the level of depigmentation~     - and used to classify patients in ten European centres. The aim of the trial is to validate~     the VETF scoring system set up in relation with the therapeutic answer to the standard~     treatment for vitiligo and phototherapy.~      Leaving aside short term side effects, such as sunrush/erythema and sunburn, which are~     reversible and infrequent, the main problem with phototherapy is represented by the~     cumulative long term effects of ultraviolet rays. These can cause premature ageing of the~     skin (photoaging) and the appearance of skin cancer/neoplasia. Therefore the aim is to get~     the best results from phototherapy whilst limiting its length.~      Aims of the trial:~        1. To validate the VETF scoring system. As phototherapy is currently the only universally~          accepted treatment for vitiligo, it seems logical to test the VETF scoring system first~          to evaluate the effectiveness of phototherapy.~        2. Secondly, the target of this multicentric trial is to compare the effectiveness of two~          different phototherapy protocols; a first protocol foresees non-stop treatment for 6~          months; a second protocol foresees periods of interruption during the treatment. This~          will help to verify whether interrupting a cycle of phototherapy is useful or not.~      This interruption might make the ultraviolet rays more effective 'stimulus on the~     melanocytes', and may also reduce long term damage caused by phototherapy.~   "
231565|NCT00525382|"~     Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic~     Idiopathic Urticaria.~   "
231566|NCT00525369|"~     In a equivalence analysis, we determined whether IL-6 can be assessed using a new~     densitometric point-of-care (POC) assay (turn-around -time: 20 minutes).IL-6 measurements~     were compared to test results obtained with conventional ELISA analysis~   "
231567|NCT00525356|"~     The objective of this study is to compare treatment with an endograft prothesis versus~     antihypertensive treatment in patients with a dissection of the thoracic aorta.~   "
231568|NCT00525343|"~     The Avonex Fifteen-year Long-term Follow-up of Patients with Relapsing Multiple Sclerosis:~     ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs (ASSURANCE), was a~     single-time-point evaluation of patients conducted 15 years after the pivotal MSCRG study,~     evaluated the impact of IM IFNβ-1a treatment on long-term disability and Quality of Life~     outcomes in patients who completed 2 years in a previous Multiple Sclerosis Collaborative~     Research Group (MSCRG) study.~   "
231569|NCT00525330|"~     To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor,~     in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how~     much of the HbA1c response is attributable to nocturnal coverage will be explored.~   "
231570|NCT00525317|"~     This is a trial of treatment with tablets containing magnesium for leg cramps in pregnancy.~   "
231571|NCT00525304|"~     This study will develop and evaluate the effectiveness of a self-management program for~     adults living with both schizophrenia and a co-occurring medical condition.~   "
231572|NCT00525291|"~     The efficacy of biofeedback and/or low frequency electrical stimulation for the treatment of~     anal incontinence has not been proven. First, large well-designed clinical trials are~     missing. Second, only few patients reach therapeutically relevant intensities with low~     frequency stimulation. In this study, a novel therapeutic concept, termed triple target~     treatment (3T) was evaluated. 3T combines stimulation with amplitude modulated middle~     frequency (AM-MF), electromyography (EMG)-triggered stimulation and EMG-biofeedback. 3T was~     compared with EMG-biofeedback alone after a nine month treatment period.~      Methods In this parallel-group randomised multicenter study with blinded observer we enrolled~     158 patients with anal incontinence. Primary endpoints were changes from baseline to nine~     months in the Cleveland Clinic Score (CCS) and the St. Mark's score (Vaizey score).~   "
231573|NCT00525278|"~     To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of~     Seasonal Allergic Rhinitis~   "
231574|NCT00525265|"~     To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake),~     efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic~     ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in~     congestive heart failure (cardiac edema) patients with extracellular volume expansion despite~     the use of a diuretic.~   "
231575|NCT00525252|"~     Intervention to achieve alcohol abstinence represents the most effective treatment for~     alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of~     anti-craving drugs in these patients because of the concern that these medications might~     worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in~     alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have~     been reported in treated patients. The present study investigates the efficacy and safety of~     baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients.~   "
231576|NCT00525239|"~     Hypothesis 1: Ritonavir-based regimens increase triglycerides and VLDL by both increasing~     VLDL production and decreasing VLDL clearance.~      Specific Aim 1A: To quantify the effect of ritonavir on VLDL production and clearance using~     stable isotope turnover and other clearance methods.~      Specific Aim 1B: To determine the composition of the triglyceride rich particles.~      Protocol 1: The effects of ritonavir-based regimens on VLDL production, VLDL clearance and~     triglyceride-rich lipoprotein composition in healthy normal volunteers. HIV-seronegative~     volunteers will be studied before and at the end of four weeks of taking ritonavir,~     lopinavir/ritonavir or atazanavir/ritonavir.~      Hypothesis 2: NNRTI drugs do not increase HDL by increasing apo AI production, but rather by~     decreasing apo AI clearance, prolonging time in circulation.~      Specific Aim 2A: To determine the composition of HDL before and after NNRTI and assess its~     function.~      Specific Aim 2B: To quantify the effect of NNRTI on apo AI production and clearance using~     stable isotopes.~      Specific Aim 2C: To determine if the NNRTI induced increase in HDL is accompanied by~     improvement in flow mediated vasodilation and circulating markers of endothelial function~     Protocol 2A: The effects of efavirenz on HDL composition, HDL function, apo AI production,~     apo AI clearance, flow mediated vasodilation and circulating markers of endothelial~     dysfunction in healthy normal volunteers. HIV-seronegative volunteers will be studied before~     and at the end of six weeks of taking efavirenz.~      Protocol 2B: The effects of starting an efavirenz-based regimen on HDL composition, HDL~     function, apo AI production, apo AI clearance, flow mediated vasodilation and circulating~     markers of endothelial dysfunction in patients with HIV infection. HIV-infected patients~     whose care providers have prescribed an efavirenz-based regimen will be studied before and~     after six weeks of starting efavirenz.~      Hypothesis 3: Ritonavir-based PI regimens impair insulin secretion. Specific Aim 3: To~     determine which ritonavir-based PI regimens alter insulin secretion.~      Protocol 3: The effects of ritonavir-based regimens on insulin secretion in healthy normal~     volunteers. HIV-seronegative volunteers will be studied before and at the end of four weeks~     of taking ritonavir, lopinavir/ritonavir or atazanavir/ritonavir.~   "
231577|NCT00525226|"~     This study will evaluate pregnant women with a past or current diagnosis of depression or~     anxiety to gain a better understanding of how these disorders can affect an infant's~     development, both during and after pregnancy.~   "
231578|NCT00525213|"~     The primary objective of this study is to evaluate the efficacy (ACR20) of Rob 803~     administered orally once daily for 12 weeks in combination with a stable dose of methotrexate~     in subjects with moderate or severe active RA.~   "
231579|NCT00525200|"~     Study Hypothesis:~      PANCHO is a prospective randomized, predictive marker study, evaluating the interaction~     between the potential predictive marker 'p53 genotype' and response to induction chemotherapy~     in patients with esophageal cancer considered resectable.~      170 patients with measurable disease will be enrolled in this study. After testing the marker~     genotype (two genotypes: p53 normal or p53 mutant) patients will be stratified according to~     histological subtype only (adeno- or squamous cell carcinoma) and will be randomly assigned~     to receive 3 cycles of either 5-fluorouracil (5FU)/cisplatin or docetaxel monotherapy as~     neoadjuvant therapy. All patients will be rendered to subsequent surgery in order to assess~     both clinical and pathohistological response.~   "
231580|NCT00525187|"~     The prevalence of onychomycosis among diabetic patients is still a debated question as well~     as the best way to diagnose the disease. We conducted a prospective study to assess the~     prevalence of onychomycosis in diabetic neuropathic (DN) patients clinically suspected of~     this disease and to assess the reliability of the diagnosis of onychomycosis.~   "
231604|NCT00524862|"~     Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with~     coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary~     prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse~     data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will~     randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy.~     The primary outcome is mortality and the study is powered as a non-inferiority trial to test~     the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute~     yearly increase) than patients receiving an ICD.~   "
231605|NCT00524849|"~     The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1~     mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth~     factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be~     randomized into two groups.~   "
231606|NCT00524836|"~     Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial~     Allergic Rhinitis.~   "
231581|NCT00525174|"~     This study is a randomized clinical trial designed to evaluate the non-inferiority of~     Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate~     amblyopia (20/40 to 20/80) in children ages 3 to < 10 years.~      Secondary objectives of this study are (1) to determine the time course of visual improvement~     with Bangerter filter treatment, (2) to compare patient quality of life, measured by a~     modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter~     filters, (3) to determine whether blurring the sound eye to a visual acuity worse than the~     amblyopic eye predicts improvement in acuity, and (4) to determine whether a change in~     fixation to the amblyopic eye is predictive of improvement in visual acuity.~      The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound~     eyes.~      The primary analytic approach for the amblyopic eye acuity will involve construction of a~     one-sided 95% confidence interval to assess non-inferiority based on a treatment group~     comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an~     analysis of covariance (ANCOVA) model.~      Sound eye acuity data will be reported for each treatment regimen at the 24-week visit as~     mean change (logMAR lines) from baseline and as the distribution of the number of lines of~     change from baseline.~   "
231582|NCT00525161|"~     The purpose of this study is to determine the clinical response rate to sorafenib when added~     to existing endocrine therapy in patients with advanced breast cancer.~   "
231583|NCT00525148|"~     The primary objective of this open-label, single arm Phase II trial is to explore the~     efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by RECIST~     criteria in patients with advanced NSCLC Stage IIIB or IV whose tumors harbor activating~     mutations within exon 18 to exon 21 of the EGFR receptor. Patients progressing or relapsing~     after one prior cytotoxic chemotherapy regimen as well as chemotherapy naïve patients (only~     in stage 2) will be allowed to enter into the trial.~   "
231584|NCT00525135|"~     RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive,~     which will allow for detection of tumor and make further ablation treatment effective.~   "
231585|NCT00525122|"~     Hypothesis: What is the natural course after treatment with radioactive iodine in patients~     with hyperthyroidism?~      What are the determinants for the development of acute hypo- or hyperthyroidism after~     treatment with radioactive iodine without antithyroid drugs?~   "
231586|NCT00525109|"~     The purpose of this study is to determine the genetic basis of one family's hereditary~     hyper-HDL-emia using multiple modalities such as linkage analysis and gene array.~   "
231587|NCT00525096|"~     To discover if the adding of a coxib increases the efficacy of the Aromasine.~   "
231588|NCT00525083|"~     Coronary heart disease (CHD) is the single leading cause of death in the United States .~     Serum Cholesterol is known to have a direct impact on a number of human diseases through a~     variety of mechanisms. This is particularly true of cardiovascular disease. Measurement and~     manipulation of serum cholesterol has become a primary focus of primary care physicians and~     cardiologists when attempting to reduce risk of heart disease.~   "
231589|NCT00525057|"~     The primary endpoint of the study would be to determine the safety of dalteparin as~     prophylaxis against deep venous thrombosis (DVT) in orthopaedic oncology patients.~     Specifically, the goal of the study is to determine whether there are significantly increased~     bleeding complications at the surgical site after major oncologic operations in the lower~     extremity. The study would help establish specific parameters for use of dalteparin in~     complex orthopaedic oncology patients. Not all patients would be appropriate for this~     medication, particularly those with massive hemorrhage during surgery and those with~     underlying coagulopathies. It is likely that patients requiring limited tumor excision,~     particularly those with metastatic carcinoma, would be ideal candidates for dalteparin~     therapy. Patients who require radical resections of tumor may need stricter guidelines for~     the safe use of the medication, since the potential for post-operative bleeding may be~     greater.~   "
231590|NCT00525044|"~     The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg~     in the treatment of sore throat in patients with acute viral pharyngitis.~   "
231591|NCT00525031|"~     The goal of this clinical research study is to learn if temozolomide alone or given with~     pegylated interferon alpha-2b can help to control metastatic melanoma. Researchers also want~     to study the safety of these 2 treatments.~      Objectives:~        1. To determine the anti-tumor activity (pathological response CR+PR) and toxicity of~          temozolomide (TMZ) alone or in combination with pegylated interferon alpha-2b (PGI) in~          patients with resectable stage IIIC or stage IV (M1a) metastatic melanoma prior to~          definitive surgical resection.~        2. To determine the relapse-free survival, overall survival and the impact of tumor~          response to chemotherapy in these patients.~        3. To differentiate the in vivo treatment effects of TMZ alone vs.TMZ plus PGI and~          correlate with clinical outcome by analysis the pre- and post-treatment tumors and~          peripheral blood mononuclear cells with respect to:~      1) Known cellular and molecular markers of apoptosis and cell proliferation, 2) Promotor~     methylation status of the DNA repair enzyme O6-methylguanine-DNA methyltransferase (MGMT), 3)~     DNA sequence variability of tumor suppressor genes and DNA repair enzymes, 4) Tumor genomic~     expression profiles analysis by complementary DNA (cDNA) microarray and protein array~   "
231592|NCT00525018|"~     Patients with peripheral neuropathy frequently exhibit treatment-refractory neuropathic pain.~     Although both peripheral and central determinants are recognized for the pathophysiological~     basis of neuropathic pain following peripheral injury, the modulating effect on pain~     processing in brain by peripheral mechanisms remains elusive. Here, we will systematically~     compare the sensory symptoms and brain activation to painful heat stimulation applied to the~     foot dorsum between patients with peripheral neuropathy and healthy controls. Functional~     magnetic resonance imaging will be used to define brain activation to thermal stimulation~     with noxious heat and innocuous warm thermal stimuli applied by contact heat stimulator.~     Brain activation during thermal stimulation in patients with neuropathic pain will be~     clarified, and we will also analyze the potential relationships between the topography,~     quality and intensity of the different painful symptoms and the magnitude and pattern of~     brain activation during thermal stimulation. This will add in our understanding in the~     pathophysiology of brain modulation in pain and provide clinically useful message toward the~     potential therapeutics in the management of neuropathic pain.~   "
231594|NCT00524992|"~     This study will examine the following: 1) how common albuminuria and proteinuria are among~     HIV-positive patients, 2) what causes albuminuria or proteinuria in these patients and 3)~     whether the condition becomes more severe over time. HIV-infected people are more likely than~     others to develop kidney disease. The earliest indicator of the possible presence of kidney~     disease is albuminuria (increased amounts of the protein albumin in the urine). A later~     indicator is the appearance of other proteins, a condition called proteinuria.~      HIV-infected patients 8 years of age and older who do not have diabetes, chronic kidney~     disease or cancer may be eligible for this study.~      Participants provide a urine sample during three visits as follows: the first upon enrollment~     in the study, a second 3 months later, and a third about 6 months after that. Blood samples~     are drawn at the first and last visits. At the first visit a medical history is taken and~     blood pressure, height, weight, waist circumference, hip circumference and upper arm skin~     thickness are measured.~      Participants who are found to have albuminuria or proteinuria are asked to undergo a kidney~     biopsy for research purposes. The procedure is optional. Participants who develop heavy~     proteinuria may be recommended to undergo a kidney biopsy in order to determine the nature of~     the kidney disease and begin treatment. The biopsy requires a 2-day hospital stay. For the~     procedure, an anesthetic is given to numb the skin and a needle is inserted and guided into~     the kidney to withdraw a small tissue sample. The needle is passed twice, and possibly three~     times. Following the procedure, the subject remains in bed rest for at least 10 hours to~     minimize the risk of excessive bleeding.~   "
231595|NCT00524979|"~     There is a differences in voice frequency of schizophrenic patients compared to patients with~     other mental diseases and compared to mentally healthy people.~   "
231596|NCT00524966|"~     RATIONALE: The use of bipolar energy sealing system or ultrasonic coagulation for hemostasis~     during thyroidectomy may reduce blood loss and hypocalcemia and may be more cost-effective.~   "
231597|NCT00524953|"~     The primary goal of thos study is to assess safety of Ultraviolet (UV) Phototherapy for the~     Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (Phase I -~     Clinical trial). Following allogeneic BMT, patients will be placed on standard GVHD~     preventive therapy (cyclosporine).~      Secondary goals -~        -  monitoring immune system recovery~        -  the influence of stem cells origin on therapy and/orGVHD prevention~        -  the influence of UV-c treatment on survival~      clinical data and samples will be collected, during UV-c therapy, 100 days after discharge &~     6 months after discharge - to examine the long-term effect of UV-c treatment on the patient's~     GVHD status.~   "
231598|NCT00524940|"~     Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine,~     Northern Hemisphere (NH) 2007-2008 formulation.~      Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza~     vaccine NH 2007-2008 formulation.~      Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics~     Evaluation and research (CBER) for further analysis by the Food and Drug Administration~     (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization~     (WHO) to support selection and recommendation of antigen strains for subsequent influenza~     vaccines.~   "
231599|NCT00524927|"~     This study aims to provide further supportive evidence that Methoxyflurane, a potent~     analgesic, administered using the Penthrox Inhaler is safe and efficacious in adult~     participants, specifically those who experience incident pain associated with a planned bone~     marrow biopsy.~   "
231600|NCT00524914|"~     Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations.~     We suppose that painful symptoms could be related to the neurotransmitter deficit of PD. So,~     we would like to evaluate the involvement of dopaminergic system in nociceptive processing in~     PD patients. The objectives of this study is to assess and to compare the effect of a~     dopamine agonist administration on the nociceptive threshold and on the cerebral activity~     using positrons emission tomography (PET scan) in two groups of PD patients (in 16 painful PD~     patients and in 16 pain free PD patients). We hypothesise that dopamine agonist could~     normalise nociceptive threshold and cerebral activity which were both abnormal in PD~     patients. Moreover, we think that painful PD patients could be more improved by dopamine~     agonist than pain free PD patients.~   "
231601|NCT00524901|"~     This is a phase 2 study that evaluates the effect of intravenous administration of a bolus~     EPO on the activation of EPOR-signal transduction cascades and myocardial apoptosis during~     cardiopulmonary bypass surgery. Human atrial and ventricular tissue will be collected during~     CABG surgery for 3-vessel disease for the assay of EPOR signaling and apoptosis. Two atrial~     specimens will be collected before and at the end of cardiopulmonary bypass (CPB).~     Concomitantly, two transmural ventricular biopsies will be obtained, at the start and at the~     end of CPB. Immediately after obtaining the first atrial biopsy, one bolus of EPO will be~     administered intravenously. The atrial tissue will be split and appropriate sections will be~     frozen for determination of baseline expression or activity of a number of molecules~     including Erk1/2, STAT5, Akt and caspase-3 or embedded in paraffin for immunohistochemistry.~     Ventricular tissue will only be processed for immunohistochemistry. Additionally, plasma will~     be collected before the procedure and for up to 30 days post-procedure to examine release of~     markers of both myocardial ischemia and stress (CK-MB, Troponin T and NT-proBNP) and renal~     dysfunction (cystatin C, creatinine for eGFR). Before initializing the randomised study, a~     pilot study will be performed with 5 subjects that will not be treated to evaluate the~     feasibility of myocardial sample collection. Initiation of the randomised study will only~     commence if baseline activity of EPOR-STC can be determined in the atrial tissue and~     caspase-3 positive cells can be identified in the second ventricular biopsy.~   "
231602|NCT00524888|"~     To assess the difference in clinical outcome between lacerations in the hand treated by~     sutures versus treated by tissue adhesive.~   "
231603|NCT00524875|"~     The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is~     effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic~     patients.~   "
231607|NCT00524823|"~     Early detection of prostrate cancer and development of metastases. The research will attempt~     to match the SCM test (structuredness of the cytoplasmic matrix) in lymphocytes as an early~     cancer detection test using Florescent Activated Cell Sorting (FACS) as a replacement for the~     CellScan instrument. The test is based on measurement of cellular changes in response to the~     specific prostate antigen, PSA.~   "
231609|NCT00524797|"~     Myelosuppression (bone marrow suppression) is the most important toxic side effect of the~     majority of chemotherapeutic agents and typically is the dose limiting factor. Death~     occurring after chemotherapy usually results either from infection related to drug induced~     leucopenia or from bleeding related to thrombocytopenia. Colony stimulating factors (CSFs)~     are widely used in the treatment of chemotherapy induced neutropenia. The same~     Erythropoetines are used in the treatment of chemotherapy induced anemia. Both treatments are~     expensive and have several side effects.~      In our previous stud (1) we found a special kind of honey: Life-Mel Honey to reduce the~     incidence of chemotherapy induced pancytopenia and improving quality of life.~      The aim of the recent planed study is to provide prophylactic and protective treatment~     against neutropenia reducing the need for secondary CSF administration in patients receiving~     chemotherapy along with a natural and non expensive honey: Profonycia.~      This honey which is expressed in Kibutz Shamir in Upper Galliee seems promising and easy for~     administration: given 5 gr/day per os for 7 days from the administration of chemotherapy.~   "
231610|NCT00524784|"~     Bone marrow transplantation (BMT) has revolutionized the treatment of hematopoietic~     malignancies.Unfortunately, graft versus host disease (GvHD) remains a major toxicity that~     greatly limits the application and efficacy of BMT.Current standard prophylaxis and therapy~     for acute GvHD include mainly the use of immunosuppressive drugs that help less than 50% of~     the patients and are associated with increased infection risk. ApoCell treatment is~     anticipated to be a prophylactic measure for acute GvHD by inducing tolerance in the donor~     effector cells, leading to a potentially significant decrease in GVHD.~   "
231611|NCT00524771|"~     The objective of this study is to characterize and compare the risks of short- and long-term~     use of NuvaRing® with marketed combined oral contraceptives.~   "
231612|NCT00524758|"~     To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC)~     in glaucoma surgery.~      The ologen collagen matrix implantation procedure is same as traditional trabeculectomy~     except implant the ologen collagen matrix on the top of sclera flap after one loose stich the~     sclera flap. The MMC application is as the standard.~   "
231613|NCT00524745|"~     To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1~     of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months),~     results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are~     similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2,~     6 months.~   "
231614|NCT00524732|"~     To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the~     reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last~     previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as~     TD/Td).~   "
231615|NCT00524719|"~     Distal radius fractures are the most common fracture to occur in the adult population, and~     those which are displaced but maintain joint congruity are the most common subtype.~     Locking-plate technology represents a true advance in the fixation of these fractures,~     especially in view of the ever increasing incidence of these injuries in an ageing and~     osteoporotic population throughout Europe and North America. These plates permit rigid~     fixation, even in osteopenic bone, while avoiding any tethering of soft tissues, as seen with~     external fixation and percutaneous pinning. For these reasons, this mode of fracture fixation~     has rapidly gained popularity. Unfortunately, there is presently little evidence to support~     their use over the more traditional methods of fixation (percutaneous pinning, external~     fixation). In addition, the technique for their application is more invasive and their cost~     is considerably greater than these latter two techniques. As such, it is pertinent to~     evaluate, in a scientifically sound fashion, the outcome of fixation with the three types of~     implant included in this study. The results of this clinical trial will allow the orthopaedic~     community to confidently recommend the fixation method which provides the optimal functional,~     clinical, and radiographic outcome for a patient suffering a displaced distal radius with~     preserved joint congruity.~      Null hypothesis: There is no difference in the functional, clinical, and radiographic~     outcomes of the three treatment methods.~      Hypothesis: Given the locking nature of modern screw-plate constructs, which produce~     excellent fixation even in osteopenic bone and permit early range of motion exercises; and~     given that plate fixation, in contrast to external fixation and percutaneous pinning, does~     not tether muscle, tendon, or capsule; plate fixation with a volar fixed-angle device should~     permit earlier and more aggressive rehabilitation and more rapid and complete regain of hand~     and wrist function when compared to stabilization with external fixation or percutaneous~     pinning.~   "
231616|NCT00524706|"~     Introduction:~      S-1 is promising drug which could replace 5-fluorouracil plus l-leucovorin (5-FU/l-LV) in~     treatment of advanced colorectal cancer.~      Phase I/II study of S-1 plus Oxaliplatin (SOX) demonstrated its promising activity with~     acceptable toxicity as first-line chemotherapy in patients with untreated metastatic~     colorectal cancer and S-1 showed equivalent possibility to 5-FU/l-LV. On the other hand,~     phase I/II study of S-1 plus oral Leucovorin (S-1/LV) demonstrated that this regimen had~     enhanced efficacy in comparison with S-1 alone. From these results, it was expected that~     S-1/LV plus Oxaliplatin (SOL) would be more effective than SOX.~      Therefore, phase I/II study of SOL combination therapy was planned.~      Purpose A dose-finding study of S-1/LV plus Oxaliplatin (SOL) was planned to determine the~     recommended dose (RD), and to assess the response rate (RR) in patients with untreated~     metastatic colorectal cancer. The primary endpoints of the phase I portion are determination~     of the RD of SOL, and safety.~      The phase II portion of this study was aimed to assess the RR of SOL.~   "
231617|NCT00524693|"~     There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased~     cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast~     (Singulair©) approved for use in infants as granule sachets, have become available. We~     evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute~     phase of RSV bronchiolitis.~   "
231618|NCT00524680|"~     RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.~      PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D~     works in treating patients with prostate cancer.~   "
231619|NCT00524667|"~     OBJECTIVES~      To investigate:~        -  the mechanism of Valproic Acid (VPA)-induced apoptosis in B-CLL~        -  the ability of VPA in combination with standard chemotherapy or new antitumor agents to~          induce a synergistic antitumor effect in chronic lymphocytic leukemia (CLL) cells~        -  the clinical efficacy of VPA in previously treated CLL patients.~      This will be an example of a translational research study where the results of our laboratory~     studies will be applied to a clinical trial in the CLL clinic at CancerCare Manitoba.~   "
231620|NCT00524654|"~     The purpose of this study is to test the effect of high velocity low amplitude (HVLA)~     chiropractic cervical manipulation on the patient's postural control as measured by a force~     plate.~   "
231621|NCT00524641|"~     To investigate the change in patient's asthma symptom control using ACQ scores after 4 to 6~     weeks of Symbicort Turbuhaler (budesonide/ formoterol) in SMART approach.~   "
231623|NCT00524602|"~     Patients with several heart arrythmia can potentially be cured by catheterablation. For some~     arrythmias 95% of the patients are cured. Also patients with atrial fibrillation are cured by~     catherablation even though the effect is not as impressive as for other cardiac arrythmias.~     About 70% of patients with paroxystic and persistant atrial fibrillation are cured. Most of~     the remaining obtain a reduction of their symptoms.~      At conventional ablation of atrial fibrillation the catheters are manually navigated to the~     ideal anatomic position where to isolate the pulmonary veins from the left atrium.~      Lately it has been possible to navigate the ablationcatheters using 'remote magnetic~     navigation' using a magnetic based navigation equipment, Stereotaxis.~      The Heartcentre of Rigshospitalet had this Stereotaxis equipment installed in the autumn of~     2006.~      We will investigate the utility and safety of using this remote magnetic~     navigation/Stereotaxis.~   "
231624|NCT00524589|"~     RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to~     grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor~     cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an~     effective treatment for prostate cancer that did not respond to hormone therapy .~      PURPOSE: This phase II trial is studying how well giving calcitriol together with~     dexamethasone works in treating patients with prostate cancer that did not respond to hormone~     therapy.~   "
231625|NCT00524576|"~     To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when~     given to subjects who had received primary vaccination of Engerix™-B vaccine approximately~     72-78 months ago.~      This protocol posting deals with objectives & outcome measures of the challenge phase. The~     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
231626|NCT00524563|"~     The primary objective is to assess for independent predictors of in-hospital mortality (up to~     28 days) in patients with Acinetobacter bloodstream infection. Secondary Objectives include~     the following: To determine the impact of inactive empiric antimicrobial therapy, defined as~     receipt of empiric antimicrobial therapy with no in vitro activity against the offending~     isolate for at least 24hrs, on the outcome (end points defined below) of patients with~     Acinetobacter bloodstream infection. To determine the impact of carbapenem resistance and~     pan-drug resistance (defined as resistance to all antimicrobials except colistin and/or~     tigecycline if these agents were tested) on the outcome of patients with Acinetobacter~     bloodstream infection. To assess the efficacy of varying definitive therapies on the outcome~     of patients with Acinetobacter bloodstream infection. To characterize the molecular~     epidemiology of Acinetobacter on a global level, as determined by pulsed-field gel~     electrophoresis (PFGE) and other techniques, and to assess whether patient outcomes are~     clonally related and to characterize the mechanisms of resistance in Acinetobacter on a~     global scale.~   "
231627|NCT00524550|"~     A body of epidemiologic studies show that moderate alcohol consumption is associated with a~     protective effect against type 2 diabetes. The importance of both insulin sensitivity and~     insulin secretion in the pathogenesis of glucose intolerance and diabetes type 2 is widely~     recognized. Clinical studies show improved insulin sensitivity after a period of alcohol~     consumption compared to abstention. However, postprandial insulin secretion and beta-cell~     function after a period of moderate alcohol consumption have scarcely been addressed in~     published literature.~      When consumed as an aperitif or with a meal, alcohol is generally expected to stimulate~     appetite and food intake and thus might be a risk factor for over consumption and obesity.~     However the physiological mechanisms for this observed effect are not well understood.~     Furthermore, previous studies lacked a link between physiological parameters and subjective~     parameters of satiety.~   "
231628|NCT00524537|"~     The purpose of this Registry study is to evaluate the long-term safety and effectiveness of~     adalimumab in CD subjects who are treated as recommended in the product label.~   "
231629|NCT00524524|"~     This study is designed to evaluate the response of several biomarkers in patients treated~     with ARQ 501. The results of the study may help the sponsor understand the effect of the~     study drug on these biomarkers and their respective role in cancer growth control.~   "
231630|NCT00524511|"~     Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The~     usual way to close this opening is with metal surgical staples. In many other types of~     surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at~     the University of Massachusetts believe Dermabond may be a safe alternative to using staples~     at the time of a cesarean delivery, but this has not been studied. Women who choose to~     participate will be randomly assigned to have the cesarean delivery skin incision closed with~     staples or Dermabond. The researchers will survey the patients to see how they felt about the~     experience and the appearance of their scar. The researchers will survey physicians~     performing the surgery to see how easy Dermabond was to use. The researchers will ask~     physicians to evaluate the appearance of the incision after a 6-week recovery period and will~     analyze complications (such as bruising, infection, or separation of the wound) in the two~     groups.~   "
231631|NCT00524498|"~     The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic~     arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly~     advanced hepatocellular carcinoma for which resection therapy or local therapy is~     inapplicable due to advanced vascular invasion.~   "
231632|NCT00524485|"~     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a~     certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic~     therapy using topical aminolevulinic acid may be effective against actinic keratosis.~      PURPOSE: This randomized clinical trial is studying how well different photodynamic therapy~     regimens using topical aminolevulinic acid work in treating patients with actinic keratosis.~   "
231633|NCT00524472|"~     Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will~     be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood~     glucose levels intra-operatively. Group B will be administered insulin at the standard of~     care levels established by the participating institution. Patients will be followed at 10~     days, 15 days and one year post-operatively.~   "
231650|NCT00524251|"~     The purpose of this study is to determine whether the improvement in the quality of life~     after an initial treatment with esomeprazole 40mg for reflux disease is the same in patients~     who have already made lifestyle-adjustments as in patients who have not implemented~     lifestyle-adjustments prior to the start of treatment (baseline)~   "
231634|NCT00524459|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) and giving them~     before surgery may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin~     together with docetaxel before surgery and to see how well it works in treating women with~     locally advanced breast cancer that can be removed by surgery.~   "
231635|NCT00524446|"~     This study tests the hypothesis that infants receiving milk-powder containing fortified~     spread (lipid-based nutrient supplement) as a complementary food for one year have lower~     incidence of severe stunting (poor length gain) than infants who are provided with no extra~     food supplements or maize-soy flour for complementary porridge.~   "
231636|NCT00524433|"~     The randomized patients with acute heart failure will be stratified based on the presence or~     absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the~     first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of~     the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days~     after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up~     period of 5 months for vital status.~   "
231637|NCT00524420|"~     While acute pain after surgery or trauma comes on suddenly and lasts for a limited amount of~     time, chronic pain persists and can continue for months and even years. Repetitive~     transcranial magnetic stimulation (rTMS) uses a magnetic field to deliver a current to the~     brain and can affect brain activity. The purpose of this study is to determine the~     effectiveness of rTMS treatment in reducing chronic widespread pain in women.~   "
231638|NCT00524407|"~     The purpose of this study was to compare the effectiveness of epoetin alfa treatment on~     hemoglobin (Hb) response, quality of life (QoL), health care resource utilization and patient~     productivity when epoetin alfa was administered during chemotherapy to patients with mild~     anemia or after waiting until patients became moderately anemic. Patients with lymphoma,~     chronic lymphocytic leukemia (CLL) or Multiple Myeloma (MM) were studied.~   "
231639|NCT00524394|"~     Infants in the NICU are at high risk for morbidity and mortality from infections of any~     onset. Diagnosis of these infections is imperfect at best. Patterns of inflammatory and~     regulatory proteins (cytokines & chemokines, in addition to antigen detection on antibody~     secreting cells (ASC's)may provide a more accurate and rapid approach to diagnosis of~     infections in these high-risk patients.~   "
231640|NCT00524381|"~     The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF)~     antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR).~      PMR is a common inflammatory disease with an unknown etiology that is characterized by~     aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central~     role in the pathophysiology of PMR.~      The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a~     subset of patients have a more prolonged, relapsing disease course. These patients require~     treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.~   "
231641|NCT00524368|"~     The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv)~     800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in~     early antiretroviral (ARV)-experienced patients when given along with selected optimized~     background regimen (OBR).~   "
231642|NCT00524355|"~     To describe the frequency, type and severity of the symptoms in patients visiting the GI or~     internal physicians, with symptoms consistent with gastroesophageal reflux disease (GERD)~   "
231643|NCT00524342|"~     The purpose of this study is to determine the efficacy and safety of rhIL-11, when given~     subcutaneously for six consecutive months, in reducing menstrual blood loss in women with~     type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by~     subjective bleeding severity scale and pictorial bleeding chart. Safety will be measured by~     the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias,~     fluid retention, or edema.~   "
231644|NCT00524329|"~     The purpose of this study is to compare the treatment effect in patients with upper~     gastro-intestinal complaints with an elevated risk for NSAID-associated GI-damage to those~     without an elevated risk for NSAID-associated damage (as determined by the treating~     physician).~   "
231645|NCT00524316|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Chemoembolization kills tumor~     cells by blocking the blood flow to the tumor and keeping chemotherapy drugs, such as~     doxorubicin, near the tumor. Giving sunitinib together with chemoembolization may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving sunitinib together with~     chemoembolization works in treating patients with liver cancer that cannot be removed by~     surgery.~   "
231646|NCT00524303|"~     This study will examine safety and efficacy of Lapatinib in combination with a standard~     neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor~     tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to~     treatment.~   "
231647|NCT00524290|"~     The objectives of this multinational study are to assess the clinical outcomes of patients~     with Acinetobacter bloodstream infection and to further assess the predictors of mortality in~     this patient population. We also aim to characterize the molecular epidemiology of this~     remarkable organism in an attempt to further understand its transmission dynamics on a global~     level and to determine whether increased pathogenicity is geographically dependent.~   "
231648|NCT00524277|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may~     stimulate the immune system in different ways and stop tumor cells from growing. It is not~     yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer.~      PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works~     compared with GM-CSF in treating patients with breast cancer.~   "
231649|NCT00524264|"~     This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the~     treatment of inflammation and pain associated with cataract surgery.~   "
232255|NCT00516230|"~     Correct identification of Lynch syndrome at the time of colorectal cancer presentation is~     important. We aim to find best ways to screen patients with colorectal cancer in Korea.~   "
231652|NCT00524225|"~     The purpose of this study is to determine the efficacy and safety of rhIL-11 when given~     subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or~     major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and~     severity of bleeding and transfusion requirement during and after surgery. Safety will be~     measured by the frequency of adverse events, including fever, headache, fatigue, myalgias,~     arthralgias, fluid retention, or edema.~   "
231653|NCT00524212|"~     The purpose is to exam prospective if simple clinical information in combination with a~     normal s-procalcitonin are sufficient for exclusion of infective endocarditis (IE).~   "
231654|NCT00524199|"~     The purpose of this research study is to examine the effect of a drug called mesna on the~     removal of homocysteine from blood during dialysis. Homocysteine is an amino acid (protein~     building block) found in the blood of all people, however it is considerably elevated in~     dialysis patients. People with increased levels of homocysteine in their blood are at~     increased risk of developing plaque buildup in their arteries and other related problems such~     as heart attack and stroke. This study will determine if mesna can improve the rate of~     homocysteine removal from blood during dialysis.~   "
231655|NCT00524186|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     sunitinib together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib when~     given together with irinotecan, fluorouracil, and leucovorin in treating patients with~     advanced stomach cancer or gastroesophageal cancer.~   "
231656|NCT00524173|"~     This study will test whether the combination of two medications, tenofovir and emtricitabine,~     are safer and more effective for treating chronic hepatitis B than tenofovir alone. Chronic~     hepatitis B is a liver disease caused by infection with the hepatitis B virus. Several~     medications, including standard and pegylated interferon and the anti-viral drugs lamivudine,~     adefovir, entecavir and telbivudine, are currently used to treat the disease. Problems are~     associated with all of these agents, however, including development of viral resistance with~     long-term therapy of the anti-virals. Since many patients require long-term therapy to~     prevent their disease from worsening, a major goal of new approaches to treatment is to~     prevent the development of viral resistance. Combination treatment has been shown to be an~     effective strategy in preventing this resistance.~      Tenofovir is an anti-viral drug approved for use in patients with HIV infection. In small~     studies in patients infected with both HIV and hepatitis B, tenofovir lowered the level of~     hepatitis B virus in the blood, with no viral resistance reported when used for up to 5~     years. Emtricitabine is an anti-viral drug similar to lamivudine and is effective at lowering~     viral load and improving liver damage.~      Patients 18 years of age and older with chronic hepatitis B may be eligible for this study.~     Participants are admitted to the NIH Clinical Center for a complete medical history and~     examination, including blood and urine tests, chest X-ray, electrocardiogram, abdominal~     ultrasound, Fibroscan (ultrasound exam of the liver that measures the amount of scarring),~     bone mineral density scan and liver biopsy. They are then randomly assigned to take~     combination treatment with tenofovir plus emtricitabine or tenofovir alone for at least 48~     weeks. During the treatment period, patients visit the Clinical Center for blood tests and a~     physical examination every 2 weeks for the first month and then every 4 to 12 weeks. After 48~     weeks, patients are readmitted to the Clinical Center for a complete evaluation that includes~     all the tests done at the start of therapy, including a liver biopsy. Patients who seem to~     have improved with treatment may continue therapy for up to 192 weeks, when they are again~     admitted to the Clinical Center for a complete medical evaluation and liver biopsy. Patients~     whose condition has not improved after 48 weeks of treatment have their treatment changed or~     stopped and continue to have regular outpatient clinic visits for 24 more weeks.~   "
231657|NCT00524160|"~     The purpose of this study is to assess the degree of pain control achieved by treatment with~     fentanyl, administered via adhesive patches applied to the skin ('transdermal system) in~     patients with rheumatoid arthritis or osteoarthritis of the knee or hip. Treatment will be~     administered fo r4 weeks, added on to existing therapy with other medications.~   "
231658|NCT00524147|"~     Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant~     residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in~     addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and~     to decrease the occurrence of RPT. However, contradictory results are reported without clear~     reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early~     effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten~     resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term~     functional outcome in patients with TB pleurisy.~   "
231659|NCT00524134|"~     In up to 1 out of 3 patients with epilepsy, seizures continue to occur despite the use of one~     or more antiepileptic medications. Patients also have significant problems with side-effects~     of these medications as doses are increased.~      Our body naturally generates miniature pumps located on the surfaces of many organs to get~     rid of toxic substances, and antiepileptic medications can be considered by the cells of the~     body to be a toxin. Research with epileptic brain regions have shown an increase in the~     amount of drug pumps, therefore getting rid of antiepileptic drugs. One of these pumps is~     called p-glycoprotein (P-gp for short). Medications may be unable to penetrate and stay~     within the parts of the brain that need them them most. This may mean that the amount of drug~     is actually lower in the parts of the brain that cause seizures, and higher in the rest of~     the brain, which may be why patients may still feel side-effects when seizures are still~     occurring.~      Research in animals has shown that blocking the P-gp pumps can improve how bad, and how many~     seizures occur as well as the length of seizures. Blockage of the pumps can be done using a~     different type of medication. Some medications that are used for common problems have been~     discovered to also block P-gp pumps. One of these, carvedilol, is used to treat heart failure~     and high blood pressure. It has been found to be very safe in these patients, and does not~     have a lot of side-effects. We plan to add this medication in addition to patient's~     anti-seizure medications to see if it will improve epileptic seizures.~      The reason why some patients have high amounts of P-gp pumps and others do not may be related~     to their genetics. A simple blood test can be used to determine a person's potential to~     produce high quantities of the pumps. This study will also attempt to show that the genetics~     will affect how well the P-gp blocking will work.~   "
231660|NCT00524121|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     erlotinib together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation~     therapy works in treating older patients with stage I, stage II, stage III, or stage IV~     esophageal cancer.~   "
231661|NCT00524108|"~     The objectives of this study are:~        -  To describe the incidence of clinical features in adults with internal~          ventriculoperitoneal (VP) shunt infections,~        -  To determine the validity of laboratory parameters in adults with internal~          ventriculoperitoneal shunt infections and~        -  To evaluate the relationship between the timing of shunt re-implantation with the rates~          of relapse and secondary infection.~   "
231710|NCT00523458|"~     Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the~     sites where the virus is located, this study is designed to see whether it is necessary to~     use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with~     rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of~     4 arms (see below) and will be followed during the time when they are receiving both~     treatments.~   "
231662|NCT00524095|"~     Bronchiectasis is a chronic pulmonary disease characterized by an irreversible dilatation of~     the bronchi. The current view of the pathogenesis of bronchiectasis considers initial~     colonization of the lower respiratory tract by different microorganisms as the first step~     leading to an inflammatory response characterized by neutrophil migration within the airways~     and secondary secretion of a variety of tissue-damaging oxidants and enzymes such as~     neutrophil elastase and myeloperoxidase. Persistence of microorganisms in the airways because~     of impairment in mucus clearance may lead to a vicious circle of events characterized by~     chronic bacterial colonization, persistent inflammatory reaction, and progressive tissue~     damage. The exact prevalence of bronchiectasis in COPD patients is not known. It would be~     important to assess the prevalence, the kind of bronchiectasis and the bacterial~     colonisation. These are all important features that can be related to the natural history of~     COPD and to the therapeutic management of patient with COPD and bronchiectasis. Recent data~     indicate that macrolide long-term treatment and inhaled steroids therapy are both associated~     with a reduced rate of exacerbation, bronchial colonization and inflammation The present~     study will address, on a relatively large number of patients, the prevalence of~     bronchiectasis in COPD subjects using a multislice CT scan technique applied in all the units~     and centrally analysed by Unit 2 and 4. This analysis will determine the presence and the~     morphology of bronchiectasis. Bacterial colonization and inflammatory parameters will be~     evaluated on blood and exhalate bronchial condensate. Concerning bacterial colonization~     molecular biology techniques (Qualitative PCR and quantitative real time PCR) will be~     applied. ELISPOT technique for the evaluation of specific immune response will be~     used.Electron and optical microscopy techniques will be applied on bronchial biopsy samples~     obtained in a subgroup of patients enrolled. During the second study year, a randomized trial~     on patients with bronchiectasis will be performed. Patients will be randomized to receive a~     macrolide or inhaled steroids or standard of care for 6 months with a follow-up of 6 months.~     All the inflammatory, microbiologic and functional parameters described above will be~     recorded. A clinical and functional evaluation will be applied looking to number of~     exacerbations, quality of life, respiratory function parameters.~   "
231663|NCT00524069|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and~     capecitabine together with bevacizumab may kill more tumor cells.~      PURPOSE: This clinical trial is studying the side effects and how well giving gemcitabine and~     capecitabine together with bevacizumab works in treating patients with pancreatic cancer that~     can be removed by surgery.~   "
231664|NCT00524056|"~     The purpose of this study is to evaluate the effectiveness, safety and tolerability of~     carisbamate treatment for the signs, symptoms, and impairment associated with Essential~     Tremor (ET) compared to placebo treatment. The secondary objective is to evaluate the effect~     of carisbamate treatment on indicators of affect and mood in patients who have ET compared to~     placebo treatment.~   "
231665|NCT00524043|"~     The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of~     paliperidone Extended Release (ER) as compared with placebo when used to treat patients with~     schizophrenia.~   "
231666|NCT00524030|"~     This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by~     itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment~     of partial seizures. The duration of the trial is about 6 months.~   "
231667|NCT00524017|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block abnormal cell growth in~     different ways. Some block the ability of abnormal cells to grow and spread. Others find~     abnormal cells and help kill them or carry cell-killing substances to them.~      PURPOSE: This randomized phase II trial is studying how well cetuximab works in treating~     patients with precancerous lesions of the upper aerodigestive tract.~   "
231668|NCT00524004|"~     This is a Phase II, randomized, double-blind, placebo-controlled study designed to~     investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect~     subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study~     will also evaluate safety and tolerability of these bovine milk IgG products and describe the~     immune responses following challenge.~      The primary study objectives are: 1) Assess safety of the anti-CsbD and anti-CS17 bovine milk~     IgG among healthy adult volunteers when orally administered three times a day over 7 days. 2)~     Determine efficacy of the anti-CsbD bovine milk IgG preparation against ETEC diarrhea upon~     challenge with CS17-ETEC, and 3)Determine efficacy of the anti-CS17 bovine milk IgG~     preparation against ETEC diarrhea upon challenge with CS17-ETEC. A secondary objective is to~     determine efficacy of the anti-CsbD and anti-CS17 bovine milk IgG preparations against~     moderate to severe ETEC diarrhea upon challenge with CS17-ETEC.~   "
231669|NCT00523991|"~     A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the~     efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler~     once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol~     (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.~   "
231670|NCT00523978|"~     This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical~     investigation conducted at 26 investigational sites in the United States and Canada. Subjects~     with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy~     failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or~     sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a~     Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and~     symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic~     electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated~     trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90~     days after study therapy was initiated was considered a blanked period for all subjects.~   "
231687|NCT00523757|"~     Heart failure causes significant morbidity and mortality and is the most rapidly increasing~     cardiovascular diagnosis in North America overall prevalence is estimated at 0.4% to 2.4%.~     Recently, heart failure with a preserved ejection fraction (HFNEF) was found in up to 50% of~     patients with symptomatic heart failure. Many studies have demonstrated that HFNEF has a poor~     prognosis with a mortality rate of up to 8% per year and a 50% chance of needing to be~     admitted to hospital in the next year. There are no proven therapies for this type of heart~     failure.~      Aldosterone blockers (these drugs block a hormone that is elevated in patients with heart~     failure) are used in other types of heart failure. Our goal is to see if this type of drug~     improves the function of the heart by looking at the thickness of the heart muscle using MRI.~     Also we will measure the amount of tissue formation and breakdown in the heart. The trial~     will be done using both the drug and a placebo so that we can see what effects are due to the~     drug.~   "
232304|NCT00515580|"~     This is a pilot study to determine the usefulness of a newly developed, minimally invasive~     tongue suture procedure for people with obstructive sleep apnea.~   "
231671|NCT00523965|"~     Rationale~      The overall objective of this trial is to identify a safe and effective combination,~     (co-administration) short course treatment for the treatment of VL which could be easily~     deployed in a control programme. The hypothesis is that the combination treatment is as~     effective or better than the 5 mg/kg single dose of AmBisome and will reduce the risk of~     parasite resistance occurring. Safety and tolerability should be such that the combination~     can be easily deployed.~      Objective~      The specific primary and secondary objectives are as follows:~      Primary objective:~      To identify a short course combination treatment regimen which is at least as effective as a~     single dose of AmBisome 5mg/kg~      Secondary objective:~      To compare safety and tolerability of the various treatments measured by vital signs, blood~     biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse~     event reporting~      Primary Endpoint:~      The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of~     treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6~     months post treatment.~      Parasitology is only carried out at any time during follow-up or at six months post treatment~     if there are signs or symptoms of VL infection.~   "
231672|NCT00523952|"~     Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with~     moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice~     daily for 3 weeks and then once daily until all lesions were cleared~   "
231673|NCT00523939|"~     The purpose of this study is to determine the response rate of lymphomatous meningitis or~     leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well~     to the study drug, and the response of symptoms to the study drug will also be determined.~   "
231674|NCT00523926|"~     The purpose of this study is to assess the effects of 3 different oral doses of TMC207~     administered over a 7 day period on the organism that causes tuberculosis~   "
231675|NCT00523913|"~     This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks~   "
231676|NCT00523900|"~     Intervention study in malnourished adults to assess whether a nutritional supplement given~     for 8 weeks in addition to the subject's usual diet improves body weight, body composition,~     biochemical and immune parameters.~   "
231677|NCT00523887|"~     The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain~     treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a~     selective activity on µ receptors.~   "
231678|NCT00523874|"~     Previously our retrospective study showed that almost half of the patients with acute~     alcoholic pancreatitis had a recurrent attack in the long-term, mild pancreatitis and young~     age being risk factors for recurrence. The aim of this prospective follow-up study was aimed~     to find out the risk factors in detail.~   "
231679|NCT00523861|"~     Moderate alcohol consumption is associated with a decreased risk of type II diabetes~     mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol~     consumption significantly improved postprandial glucose concentrations. Similar observations~     were made in our previous study. One of the mechanisms by which this may occur is delayed~     gastric emptying after alcohol consumption.~   "
231680|NCT00523848|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride~     liposome, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma~     by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin~     hydrochloride liposome and thalidomide may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin~     hydrochloride liposome and thalidomide works as first-line therapy in treating patients with~     previously untreated multiple myeloma.~   "
231681|NCT00523835|"~     Klinefelter syndrome (KS) is the most common sex-chromosome disorder with a prevalence of one~     in 660 men and is a frequent cause of hypogonadism and infertility. It is caused by the~     presence of extra X-chromosomes, the most common karyotype being 47,XXY. The phenotype is~     variable, but the most constant finding is small hyalinized testes, hypergonadotrophic~     hypogonadism, infertility, eunuchoid body proportion, increased height and learning~     disabilities. Klinefelter syndrome has been associated with increased prevalence of diabetes,~     osteoporosis and cardiovascular diseases but the pathogenesis is unknown. Accordingly the aim~     of the study was to investigate measures of body composition, insulin sensitivity, bone~     mineral density, echocardiography, as well as biochemical markers of endocrine, metabolic and~     bone function in KS and an age-matched control group.~   "
231682|NCT00523822|"~     This study seeks to determine if the correction of a sacroiliac lesion can produce a~     functional change in cervical spine. Reduction of a sacroiliac joint lesion may alter~     cervical spine function.~   "
231683|NCT00523809|"~     The goal of this clinical research study is to learn if giving Avastin (bevacizumab) with~     standard chemotherapy and a blood stem cell transplant, in patients with an advanced solid~     tumor, can help to shrink the tumor or slow its growth. The safety of this treatment will~     also be studied.~   "
231684|NCT00523796|"~     This is a multi-centre survey of patients who are currently on lipid-lowering pharmacological~     treatment. Data collection for each patient will take place at one visit.~   "
231685|NCT00523783|"~     To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or~     schizoaffective disorder~   "
231686|NCT00523770|"~     GSK Biologicals is working on the development of a vaccine to protect elderly people from~     pneumococcal infection. For the future studies in that project, it would be useful to have~     some easy non invasive tests to detect infection by the bacteria. Some tests on urine are~     already on the market but need to be improved in the laboratory. For that purpose, some urine~     samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia~     nor have been administered pneumococcal vaccination in the past 3 months are needed.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007~   "
231688|NCT00523744|"~     This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose~     combination in adults with moderate, inadequately controlled hypertension. There was an~     optional study extension for eligible patients who wanted to participate that contains the~     triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).~   "
231689|NCT00523731|"~     Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients~     with Critical Limb Ischemia ( ACPs-CLI )~      Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D. Head of Division of Vascular~     Surgery , Department of Surgery, Faculty of Medicine Siriraj Hospital , Mahidol University,~     BKK,Thailand~      Study objective : To determine the safety and efficacy of intramuscular injection of~     blood-borne autologous ACPs in relieving symptoms of critical limb ischemia of patients~     treated with maximal medical therapy and don't have intravascular or operative~     revascularization option.~      Study Design : A pilot study , a single center, a non-randomized, open-label trial.~      Total expected no. of patients : 6 main selection criteria : A. Subjects will have one or~     more clinical indications diagnostic of CLI such as: distal extremity pain at rest that~     requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or~     areas of gangrene ; or non-healing ischemic ulcers AND~      B. Subjects will have one or more of the following hemodynamic indicators of severe~     peripheral arterial occlusive disease:~      I. Ankle brachial index < 0.45 II. Toe brachial index < 0.35 III. TcPO2 / TcO2 of < 40 mmHg.~     C. The subject is a poor candidate for standard revascularization treatment for peripheral~     arterial disease, based on inadequate bypass conduit, or unfavorable anatomy D. Age 18 to 80~     years~      Investigational Product : At D-8 250 ml of blood drawn from the patients for production of~     autologous EPCs or ACPs (VescellTM). On D0 ,at least 1.5 million ACPs with viability >75 %~     suspended in 30 ml sterile cell culture medium will be injected 1.5 cm deep and 1.5 apart by~     a 23 -gauge needle into the gastrocnemius muscle of the leg chosen (ischemic leg) for~     treatment. For injection planning a grid of 10X10 cm will be prepared and in each point 1 ml~     of ACPs suspension will be injected.~      The study consists of 4 periods: Screening ( D-14 to-9& D-8,Treatment(D0),Acute Safety~     follow-up (D1&D2),Chronic follow-up (D30 & D90)period ,total follow-up of each case is 3~     months.~      Evaluation criteria :~      Safety : no.& duration of adverse event & serious adverse event Efficacy :Attenuate CLI~     patients symptoms (Rest pain,Pain-free walking distance,Ulcer size &Gangrene dimension and~     intensity)~   "
231690|NCT00523718|"~     Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal~     of suffering. Many patients benefit from established treatments, the mainstay of which are~     cognitive behavioral therapy and a group of antidepressant medications known as serotonin~     reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established~     therapeutic strategies. New avenues of treatment are urgently needed.~      Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin~     or dopamine; but increasing evidence suggests that functional disruptions of a different~     neurotransmitter, glutamate, may contribute to some cases of OCD. The investigators are~     therefore interested in using medications that target glutamate as novel treatment options~     for those OCD patients who do not benefit from established treatments.~      One such medication is the drug riluzole, which is FDA approved for amyotrophic lateral~     sclerosis (ALS), or Lou Gehrig's disease, but may be of benefit to patients with psychiatric~     disorders due to its ability to moderate excessive glutamate. In preliminary studies, in~     which the investigators treated patients with riluzole (in addition to their established~     pharmacological regimen) in an open-label fashion (that is, without a placebo-treated control~     group), the investigators have found about 40-50% of patients to substantially improve over~     2-3 months.~      While immensely promising, these preliminary studies do not prove riluzole is truly a new~     beneficial medication for the treatment of OCD; a more rigorous placebo-controlled trial is~     needed for that purpose. The investigators are therefore now recruiting patients to~     participate in a double-blind, placebo-controlled trial of riluzole, added to whatever other~     OCD medications they are taking.~   "
231691|NCT00523705|"~     The purpose of this pilot study is to determine the efficacy and safety of escitalopram~     administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in~     young women ages 15-19 years.~   "
231692|NCT00523692|"~     Rheumatoid arthritis (RA) is a debilitating chronic immune mediated inflammatory disease~     which affects 1% of the European population. RA is associated with significant joint damage,~     disability and an enhanced mortality. Current treatment strategies target patients once~     synovitis has been present for several months and it is clear that the patient has developed~     persistent disease. After the first 3 months of symptoms, we and others have shown that the~     persistence of chronic inflammation in the rheumatoid synovium is driven by hyperplastic~     stromal tissue which inhibits leukocyte apoptosis leading to the accumulation of inflammatory~     cells in the joint. Therapies at this stage of disease, with conventional disease modifying~     anti-rheumatic drugs (DMARDs) as well as drugs targeting TNF-alpha reduce disease activity~     but are unable to cure RA. We have now identified that the very early phase of synovitis in~     patients destined to develop RA (within the first 12 weeks of symptoms) represents a~     pathologically distinct phase of disease. This suggests that late disease is not just more of~     early disease and gives, for the first time, a clear rationale for very early intervention.~     Building on these recent observations, we propose to test the hypothesis that the disease~     processes in the very early stages of RA are fundamentally different to those in established~     chronic disease. This will be done by assessing whether treatment during this phase with the~     well-established gold standard modality of anti-TNF-alpha therapy and methotrexate can~     permanently switch off inflammation, preventing the development of RA and thereby effecting a~     cure of the disease.~   "
231693|NCT00523679|"~     The purpose of this study is to investigate the extent of Symbicort use in patients~     prescribed Symbicort as maintenance and reliever therapy.~   "
231694|NCT00523666|"~     Alzheimer's disease (AD) is characterized by progressive subcortical and cortical neuronal~     degeneration. AD patients differ in the time course of neuronal degeneration and accompanying~     cognitive decline.~      With recent advances in MR imaging, including optimized data acquisition and processing~     techniques, tools that are especially well suited for tracking long-term pathological changes~     as well as drug treatment effects have become available. In addition to structural imaging,~     new acquisition and analysis techniques have been developed to determine integrity of~     subcortical fiber tracts in vivo.~      In the present project we propose to determine predictors of disease progression and~     treatment response and investigate potential treatment effects on structural disease~     progression, covering the continuum from axonal degeneration to cortical neuronal loss taking~     advantage of recent advances in MRI acquisition and analysis techniques.~   "
231695|NCT00523653|"~     Dilated cardiomyopathy (DCM) affects about 200,000 Canadians. Eighty percent of these cases~     are of unclear cause, often occuring in families. We believe that mutations in specific~     already-identified genes contribute to DCM in Quebec and that certain mutations may account~     for a significant proportion of cases due to the well-documented founder effect. Two~     hundred patients with DCM followed in our Heart Function Clinic will be approached for one~     blood sample at their routine clinic visit to test this hypothesis. The samples will be~     tested in the Laboratory of Cardiovascular Genetics at the Royal Victoria Hospital.~   "
231697|NCT00523627|"~     This study, conducted at the NIH Clinical Research Unit at the Phoenix Indian Medical Center,~     will examine how the body s metabolism (energy expenditure) changes when people overeat and~     when they fast and how different diets (e.g., high-protein or high-fat) affect metabolism.~     The results may provide information about whether there are mechanisms that make some people~     more resistant than others to gaining weight when they eat more.~      Non-smoking healthy subjects between 18 and 55 years of age who weigh no more than 350 pounds~     may be eligible for this study. Participants undergo the following procedures:~        -  Pregnancy test for women of childbearing age.~        -  Oral glucose tolerance test. For this test, an I.V. line (needle attached to a plastic~          tube) is inserted into a vein to allow several blood draws without repeated needle~          sticks. After the first blood sample is drawn, the subject drinks a cola-flavored sugar~          solution. Five additional blood samples are then drawn over 3 hours.~        -  Blood test for DNA (genetic) studies related to obesity, diabetes and related medical~          problems.~        -  DEXA scan. This test measures body fat. The subject lies on a table while a very small~          dose of X-rays is passed through the body.~        -  Respiratory chamber. This test measures how many calories the body burns a day and~          assesses energy balance between intake and expenditure. Subjects stay in a room with two~          windows, equipped with a sink, toilet, television and DVD player, desk, chair, telephone~          and bed for 24 hours. The test is repeated five times during the first 18-day admission~          and 3 times during the second 13-day admission. For the first two sessions, subjects are~          fed a diet equal to the amount of energy their body uses. For the next 6 stays they are~          fed double the amount of calories their body usually uses for 5 of the stays and fast~          (consume nothing but water and soda without caffeine or calories) during 1 stay. The~          overfeeding diets may be high or low in protein, normal in protein, or high in fat.~          Blood tests are done on the day of each respiratory chamber session and a 24-hour urine~          sample is collected for one day while in the chamber.~        -  Eating behavior questionnaires.~        -  Psychological performance tests.~      Some participants are asked to volunteer to repeat two of the chamber studies to validate the~     measurements. The repeat session includes only the fasting and the overfeeding with normal~     protein content.~      All participants are followed at 6 months with blood tests, a DEXA scan, and urine tests~     (including pregnancy test for women). At annual visits for years 1 through 7, participants~     have the 6-month tests plus an oral glucose tolerance test.~   "
231698|NCT00523614|"~     The objective of this study is to compare the risk of venous thromboembolism (VTE) of oral~     contraceptives with non-use, focusing specifically on Valette® compared to other users of low~     estrogen dose combined oral contraceptives.~   "
231699|NCT00523601|"~     To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are~     diagnosed as bipolar depression~   "
231700|NCT00523588|"~     The purpose of using the 595 nm Vbeam Perfecta™ flashlamp-excited, pulsed dye laser in this~     study is to help improve study patients' skin disease. Cutaneous lupus erythematosus (CLE)~     often presents with disfiguring vascular lesions which are frequently difficult to treat with~     the available therapeutic measures, such as photoprotection, topical steroids, and~     antimalarials. Laser therapy provides an alternative treatment option for CLE patients.~     Although there has been documented experience with laser treatment in CLE patients, no study~     comparing treated lesions to the natural course of the disease has been conducted.~   "
231701|NCT00523575|"~     Hip fractures are highly prevalent and are expected to increase due to the ageing population.~     Malnutrition is often present in these patients and is associated with prolonged~     convalescence, lower mobility, lower mental function, lower quality of life and higher~     complication rate. Nutritional intervention starting soon after hospital admission might~     reduce complication rate and total length-of-stay by improving nutritional and functional~     status. Research questions are:~        1. Does nutritional intervention reduce total length-of-stay?~        2. Is nutritional intervention cost-effective?~        3. Can nutritional screening contribute to targeting of nutritional intervention, and~          thereby reduce costs without loss of effectiveness?~      Patients randomized to the intervention group will receive oral nutritional supplements~     (protein and energy enriched) and regular dietetic counselling during hospitalisation and~     after discharge at patients' homes for 3 months. Patients in the control group will receive~     usual nurse and dietetic care. Outcome measurements will be taken at baseline, 3 months and 6~     months after inclusion.~   "
231702|NCT00523562|"~     The purpose of this study is to assess how the macronutrient composition of the diet effects~        -  lipid and glucose metabolism~        -  intrahepatic lipids~        -  insulin sensitivity~      in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and~     offsprings of patients with type 2 diabetes mellitus).~   "
231703|NCT00523549|"~     The purpose of this study is to determine the effects of treatment with valsartan +~     amlodipine to a target systolic blood pressure (SBP)<130 mmHg compared to the Joint National~     Commission on the Treatment of Hypertension 7 recommended target SBP of <140 mmHg on the~     intrinsic diastolic properties of the myocardium in patients with hypertension and~     echocardiographic evidence of diastolic dysfunction.~   "
231704|NCT00523536|"~     The purpose of this trial is to study the effect of a patient navigator-nurse team in~     improving the management of hypertension and other cardiovascular disease risk factors in a~     health care system taking care of a vulnerable, mostly Latino population.~   "
231705|NCT00523523|"~     The purpose of this study is to determine whether or not having people with stroke practice~     performing tasks to auditory rhythm cues with their weaker arm and hand is any better at~     promoting improved motor control than practicing the tasks in a typical way without the~     rhythm cues~   "
231706|NCT00523510|"~     This study will investigate the feasibility of HIV positive mothers in Tanzania to correctly~     use the Flash-heat method to pasteurize their breast milk and for how long they are able to~     do so. The patients will be followed in this study for up to 3 months of Flash-heating their~     milk. Flash-heated breast milk could be a potential method to reduce mother-to-child~     transmission of HIV. The investigators will also collect infant health data to pilot a future~     efficacy trial. The investigators hypothesize that with enhanced home-based infant feeding~     counseling, mothers will be capable of Flash-heating their breast milk.~   "
231707|NCT00523497|"~     The purpose of this study is to determine whether the noninvasive ventilation is more~     effective in the treatment of severe comunity acquired pneumonia in comparison with the~     conventional mechanical ventilation with orotracheal intubation.~   "
231708|NCT00523484|"~     This study is an observational study to see whether anxiety level can be correlated with PSA~     level under the current practice in the patients of prostate cancer taking hormonal therapy.~     For assessment of anxiety level BAI(Beck Anxiety Inventory) will be used. The target~     population for this study is the patients of prostate cancer diagnosed previously and who are~     taking hormonal therapy with regular follow-up and PSA test. The follow-up duration will be~     total 6 months with interim visit at 3 month and final visit at 6 month.~   "
231709|NCT00523471|"~     To check the radiosensitivity level in individual patients based on their DNA damage level.~   "
232305|NCT00515567|"~     The goal of this study is to use the tissues from the explanted lungs in order to better~     study the cause of pulmonary fibrosis at a cellular level.~   "
231711|NCT00523445|"~     The primary objective of this project is to examine the effects of varenicline treatment used~     concomitantly with antipsychotic medications, on cognitive dysfunction in people with~     schizophrenia. The secondary objective is to evaluate the effect of this combination therapy~     on smoking in people with schizophrenia. This study will be a randomized, double blind,~     parallel group, placebo controlled 8 weeks trial.~   "
231712|NCT00523432|"~     The aim of the trial is to determine the recommended phase II dose of weekly intravenous~     topotecan in combination with a fixed dose (25 mg or 15 mg) of weekly intravenous~     temsirolimus in patients with and without prior pelvic radiation.~   "
231713|NCT00523419|"~     The primary purpose of your participation in this study is to help answer the following~     research questions, and not to provide you treatment for your condition.~        -  To assess how well treatment with pemetrexed works for patients with your type of cancer~        -  To assess for any side effects that might be associated with pemetrexed.~        -  To look at the characteristics and levels of certain of your genes and proteins to learn~          more about osteosarcoma and how pemetrexed works in your body.~   "
231714|NCT00523406|"~     To assess the CNV treatment effect of PDT with verteporfin in combination with IVTA using~     reduced fluence compared to the standard fluence.~   "
231715|NCT00523393|"~     In this trial, it will be studied whether early addition of the long acting insulin analogue~     Glargine is capable of increasing the number and differentiation of endothelial progenitor~     cells (EPC) in patients with type 2 diabetes, which can be seen as a marker of vascular~     regenerative potential and cardiovascular risk. In addition, the effect of Glargine on~     microvascular function will be studied. This will be done using laser Doppler measurements of~     the skin; in addition, MRI of the heart will be performed which is capable of quantifying the~     perfusion reserve of the myocardium and additional functional aspects of ventricular~     function. A beneficial effect of early addition of bedtime Glargine on EPC and vascular as~     well as myocardial function in this study might argue for a change in the therapeutic~     approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients~     affected.~   "
231716|NCT00523380|"~     This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of~     rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease~     after, first line therapy. Patients will be treated for 6 months.~   "
231717|NCT00523367|"~     The purpose of this study is to determine which COPD patients have GERD and if COPD patients~     with GERD treated with high dose lansoprazole for 1 year decreases the frequency of COPD~     exacerbations compared to the previous year without treatment.~   "
231718|NCT00523354|"~     Eosinophilic Esophagitis (EE) is a chronic inflammatory disorder of the esophagus with a~     constantly increasing prevalence. It has been demonstrated that the expression of the~     cytokine TNF-α is up regulated in EE and that this pro-inflammatory cytokine is highly~     expressed by the keratinocytes of the esophageal epithelium in patients with active EE.~     Furthermore, it has been shown that TNF-α is capable to induce eotaxin-3 production in~     keratinocytes. These results suggest that TNF-α plays a crucial role in the pathogenesis of~     EE. Based on these findings, the investigators plan a prospective T1 translational study with~     the purpose to evaluate the efficacy of an Infliximab monotherapy in adult patients with~     severe, corticosteroid-dependent EE.~   "
231719|NCT00523341|"~     The primary objective was to describe the safety and tolerability of up to 10 years or 7~     years denosumab administration as measured by adverse event monitoring, immunogenicity and~     safety laboratory parameters in participants who previously received denosumab or placebo,~     respectively.~   "
231720|NCT00523328|"~     This study is to observe the long-term treatment of BG9924~   "
231721|NCT00523315|"~     To describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in~     the postmenopausal, early breast cancer as seen under current practice~   "
231722|NCT00523302|"~     In this pilot study, the PI proposes to include 20 African American participants with~     Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms. The focus on~     African Americans is due to the mandate from the funding source (internal), as well as~     possible higher prevalence of FM in AA women. If recruitment is slow, the PI proposes to open~     up the study to other groups. Twenty subjects will be randomized to either sham or active TMS~     condition. Inclusion/exclusion criteria are well thought out and seem appropriate.~     mTreatments will be administered at IOP 5 times/wk with each session lasting 20 minutes. Pain~     intensity and unpleasantness will be measured pre and post each TMS session using three~     different pain evaluation paradigms. GCRC resource is mainly requested for two blood draws~     pre and post first TMS session. The blood samples will be used to measure inflammatory~     cytokines IL-1, IL-6, AND IL-8. The main aim is to ascertain feasibility of the study and~     secondary aim is to gather information on variability in response for power analysis for~     future larger study. The introduction and rationale (including pain evaluation, and methods~     relating to TMS) are clearly presented. Use of GCRC resources seem appropriate.~   "
231723|NCT00523289|"~     The purpose of this study is to determine if bupivacaine (75% levobupivacaine plus 25%~     racemic bupivacaine) with vasoconstrictor is effective and safety as ropivacaine in brachial~     plexus block for orthopedic surgery.~   "
231724|NCT00523276|"~     The purpose of this study is to understand how severe acute respiratory syndrome (SARS)~     spreads within families, if significant disease resulted, and how the body responds to SARS.~     The study will also explore the affects of SARS on genetics and the immune system (the body~     system that fights disease). Up to 1000 people residing in Beijing, China may be involved in~     this study. Adult survivors of SARS (numbering 200) and their family members including~     children age 4 and up will be asked to participate in the study. The study will recruit an~     additional 200 persons, who will be matched with SARs survivors of similar age, gender,~     health status, and housing/work location, and recruited as comparators. Blood will be taken~     from all volunteers and tested for the presence of SARS antibodies (proteins made by the~     body's immune system in response to something that can cause infection). Health and~     clinic/hospital visit records may be reviewed.~   "
231725|NCT00523263|"~     Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human~     umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.~   "
232348|NCT00514995|"~     The purpose of this research study is to study the effectiveness, tolerability and safety of~     sodium oxybate in outpatients with binge eating disorder.~   "
231726|NCT00523250|"~     A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and~     ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The~     Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic~     Solution will not be different from that of its vehicle.~   "
231727|NCT00523237|"~     The purpose of this study is to:~        -  Provide raltegravir to subjects with HIV and an undetectable viral load who are~          experiencing injection site reactions (ISR) to Enfuvirtide,~        -  Monitor the safety and efficacy of raltegravir, and~        -  Assess the change in quality of life in patients who have switched from Enfuvirtide to~          raltegravir~   "
231728|NCT00523224|"~     Study title: A Study of Combined Coronary Artery Bypass Grafting (CABG) and Blood-Borne~     Autologous Angiogenic Cell Precursors Therapy in Patients with Congestive Heart Failure due~     to Ischemic Heart Disease (ACPs-CHF) Principle Investigator: Kit V. Arom ,M.D.,Ph.D. Deputy~     Director, Chief Cardio-Thoracic Surgeon, Bangkok Heart Hospital Study objective : To~     determine the safety and efficacy of injection of blood-borne autologous ACPs into the~     non-graftable area of the heart of patients with congestive heart failure due to ischemic~     heart disease Its main goal is evaluation of feasibility and safety of the combined~     technique. The efficacy of the treatment will be tested in the following trial.~      Study Design : Phase I , a single center, a non-randomized, open-label trial to test the~     safety, of intramyocardium transepicardium administration of ex vivo expanded autologous ACPs~     administered in combination with CABG operation in patients with congestive heart failure due~     to ischemic heart disease.~      The study is a preliminary training study, under the supervision of the experienced Dr. Patel~     the U.S. principal investigator.~      Study population :~      Total expected no. of patients : 5 main selection criteria :~        1. Patients with or without signs of congestive heart failure due to ischemic heart disease~          who had maximal medical treatments. Not suitable to percutaneous intervention~        2. All patients must have a recent coronary angiogram. Patients must be able to have OPCAB~          and then have Angiogenic Cell Precursors(ACPs) in non-graftable and/or infraction~          regions~        3. Age 18 to 80 years~        4. MRI demonstrating areas of viable and non-viable myocardium Investigational Product :~          The patients will be blood drawn 250 ml at D-8 for producting autologous ACPs~          (VescellTM), On D0 ,at least 1.5 million ACPs with viability >75 % supended in 15 ml~          sterile cell culture medium will be injected 1 cm apart using a 23 gauge angled needle~          in 30 spots (0.5 ml /point) to the same patients by direct intramuscular approach at LV~          during CABG.~      The study consists of 4 periods: Screening ( D-14 to-9& D-8,Treatment(D0),Acute Safety~     follow-up (D1-2& D5-discharge),Chronic follow-up (D30 & D90)period ,total follow-up of each~     case is 3 months.~      Evaluation criteria :~      Safety : no.& duration of adverse event & serious adverse event Efficacy :NYHA, 6-minute~     walking test ,% LVEF by Echocardiography & C-MRI, % infracted scar area on C-MRI , Pro-BNP &~     3 months of QoL(SF-36)~   "
231729|NCT00523211|"~     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government~     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5~     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells~     that fight infection). Previous smaller studies in HIV treatment-experienced patients, have~     shown that vicriviroc is safe and effective. The purpose of this study is to confirm the~     previous findings in a larger phase 3 study over a 48-week period, and show that when taken~     in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV~     (viral load) in the blood and that it is well tolerated.~   "
231730|NCT00523198|"~     The purpose of the study is:~        -  to correlate salivary cortisol to free serum cortisol (as salivary cortisol is~          considered to be almost complete free cortisol) and,~        -  to correlate free serum cortisol to total serum cortisol levels~      Both in patients with septic shock (severe sepsis requiring vasopressors).~      We believe that:~        -  total serum cortisol does not correlate with free serum cortisol in patient with septic~          shock and,~        -  that salivary cortisol correlates with free serum cortisol and can be used to determine~          the level of free serum cortisol.~   "
231731|NCT00523185|"~     The purpose of this study is to compare the efficacy of two commonly used medications in the~     treatment of alcohol withdrawal, diazepam and lorazepam.~   "
231732|NCT00523172|"~     Purpose of this study is to examine the effect of chiropractic adjusting (manipulative~     therapy) and rehabilitation on hip osteoarthritis (hip OA) in older adults.~   "
231733|NCT00523159|"~     This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine~     IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma.~      Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9~     months. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide prior~     to the first vaccination.~   "
231734|NCT00523146|"~     The objectives of this clinical trial are:~        -  To further study the safety of Kanion Capsule (GF) in primary dysmenorrhea subjects;~        -  To further evaluate the efficacy of GF in treatment of primary dysmenorrhea.~   "
231735|NCT00523133|"~     The purpose of this study was to compare the effects of two psychosocial treatments that~     differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement~     Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking~     behaviors in alcohol dependent patients.~   "
231736|NCT00523120|"~     Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single~     drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption~     of oral analgesia.~   "
231737|NCT00523107|"~     The objective of this study is to conduct a trial in the spirit of providing as much as~     possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and~     safety of PG2 for relieving fatigue among advanced cancer patients who are under standard~     palliative care (SPC) at hospice setting and have no further curative options available.~     Patient's fatigue status, to be measured by the Brief Fatigue Inventory-Taiwanese Form~     (BFI-T), will be the primary endpoint. The fatigue improvement response rate among patients~     between two study arms will then be compared as the basis for efficacy evaluation at the end~     of the first treatment cycle, and will be the primary endpoint. Other endpoints, the fatigue~     improvement response rate and the mean fatigue scores change from baseline among patients~     within and between cycles will be included in the secondary efficacy endpoints, and will be~     compared between two study arms. Patients' quality of sleep, appetite, pain, fatigue, nausea,~     vomiting and global quality of life (QoL) will be also measured by 11 questions (SS11) from~     EORTC QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints include~     Karnofsky performance scores, and weight change and its related c-reactive protein level of~     the patients.~      * BFI-T (Brief Fatigue Inventory - Taiwan) : The BFI is a 9-item self-administered~     questionnaire which was developed by MD Anderson Cancer Center offers assessing levels of~     fatigue. Subjects rate each item based on how they felt for the preceding week using a 1-10~     numeric rating scale (10 being the most unfavorable response). The single construct of the~     BFI allows for the mean of the nine items to be the overall score. The score is categorized~     as mild (1-3), moderate (4-6), and severe (7-10). The scale is a reliable instrument that~     correlates highly with similar fatigue and performance status measures.~   "
231738|NCT00523094|"~     The primary objective of this study is to estimate the accuracy of the pre-operative VRI~     quantitative results versus the gold standard pre-operative perfusion scan.~      The secondary objective is to assess the correlation of the predicted post-operative lung~     function with the observed post-operative lung function (forced expiratory volume in 1 second~     [FEV1] and diffusing capacity of the lung for carbon monoxide [DLCO]) in patients who~     underwent surgical resection.~   "
231739|NCT00523081|"~     STAND is a research study testing a way to help teens between 12-18 years of age who have~     symptoms of sadness or depression. The study hopes to learn if teens do better if they get~     five to nine counseling sessions of cognitive behavioral therapy coordinated with the support~     of their doctor. All teens who join the study will keep seeing their doctor as usual.~      Teens and a parent are interviewed briefly over the phone to see if they are appropriate for~     the study. If they qualify for the study, there is an hour-long interview with teen over the~     telephone and a 30 minute interview with the parent. The interview will include questions~     about the teen's mood, feelings, behavior, and how they get along with friends and family~     members. The parent is also asked about his or her own feelings and mood. If the teen and~     parent join the study, they will be interviewed six more times in the next two years.~      Half the teens in the study will also meet with a research counselor for five to nine~     individual, weekly sessions that last about 50 minutes each. Whether a teen attends the~     weekly counseling sessions is decided by chance, like flipping a coin. If teens are assigned~     to these sessions, they will learn ways to deal with stress and feel better. If teens take~     part in the counseling sessions, the study counselor will also talk to the teen's doctor from~     time to time to help plan for the best possible care.~   "
231740|NCT00523068|"~     In patients with symptoms of mixed incontinence (loss of urine associated with~     coughing/sneezing/laughing, and loss of urine associated with the strong urge to void), is~     surgical treatment with tension free vaginal tape or pharmacological treatment with~     tolterodine more effective? What are the parameters predictive of success or failure with~     either forms of treatment? What are the parameters predictive of the necessity for further~     treatment after primary treatment?~      Patients will be randomised to having surgical or pharmacological treatment for their mixed~     incontinence symptoms. They will be assessed subjectively and objectively pre-treatment and~     after treatment at intervals up to 3 months.~   "
231741|NCT00523055|"~     Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing~     performed. The quality of physiotherapy is felt to be superior with good pain control. The~     quality of the freezing is felt to be better when it is done with ultrasound guidance. We are~     able to use less drug to achieve the same result. For this reason, we are doing a study to~     look at the level of freezing drug that accumulates in the body. We feel that the drug levels~     will be significantly different. We also feel that the time-to-peak drug level will be~     different than with traditional arm freezing procedures.~   "
231742|NCT00523042|"~     This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).~      This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin~     to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.~   "
231743|NCT00523029|"~     This study seeks to adapt an existing chronic disease self-management program for people with~     both chronic medical illness and depression.~   "
231744|NCT00523016|"~     Acupuncture has been used with good results for many years at Toronto Rehabilitation~     Institute Lyndhurst Centre (Toronto, ON, Canada), Parkwood Hospital (London, ON, Canada) and~     GF Strong Rehabilitation Institute (Vancouver, BC, Canada) to reduce burning pain in~     individuals with spinal cord injuries (SCI). This multi-centre RCT will test an acupuncture~     protocol for treatment of burning pain in 40 people with burning pain in SCI, using a sham~     acupuncture protocol as the control.~      Objectives of Study:~        1. To determine the feasibility of conducting a real acupuncture vs. sham acupuncture trial~          in a multi-centre study using the Lyndhurst Central Neuropathic Pain Acupuncture~          Protocol (LCCNPAP). This will inform a larger study which will directly evaluate the~          effect of the LCCNPAP on pain and Quality of Life (QOL) in individuals with SCI.~        2. To determine which outcome measures are most responsive and the amount of change that~          could be expected, with respect to pain and QOL, for the larger study.~        3. To obtain preliminary data to determine subject numbers for future studies evaluating~          the effect of the acupuncture protocol.~   "
231745|NCT00523003|"~     Study hypothesis: High protein diets have been shown to make people full and and help to~     retent of muscle mass. This study was designed to determine effects of a protein- enriched~     meal replacement (MR) on weight loss and muscle mass retention by comparison to an equal~     calorie carbohydrate-enriched MR.~      Methods: Single blind, placebo-controlled, randomized outpatient weight loss trial in 100~     obese men and women comparing two equal calorie meal plans.,1) 2.2 g protein/kg of LBM per~     day [high protein diet (HP)] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). Body~     weight, body composition, and lipid profiles were measured at baseline and 12 weeks.~   "
231746|NCT00522990|"~     The goal of this clinical research study is to find the highest tolerable dose of AT9283 that~     can be given to patients who have ALL, AML, CML, high-risk myelodysplastic syndromes, or~     myelofibrosis with myeloid metaplasia. Researchers want to perform pharmacokinetic (PK)~     testing on blood to find out how quickly the study drug leaves the body and how the body~     breaks down the drug. The safety and effectiveness of this drug will also be studied.~   "
231747|NCT00522977|"~     The purpose of this echocardiographic study is to restudy the longitudinal changes in cardiac~     size and function during and after pregnancy in healthy women using relatively new parameters~     of systolic and diastolic function as well as classical measures of left ventricle (LV)~     function using contemporary echocardiographic machines.~      We, the researchers at Hillel Yaffe Medical Center, will assess diastolic function and its~     possible relation to shortness of breath.~   "
231748|NCT00522964|"~     A randomized study is proposed to determine effects of 8 weeks of an interactive multimedia~     educational program compared to waiting list control group on improving health and weight~     status in Chinese-American children, ages 8 and 10, over a 6 months period. A total of 60~     Chinese-American children and their families will be randomized to either the intervention~     group or waiting list control group. The intervention is based on Social Cognitive Theory and~     principles of Chinese culture and practices. The intervention program includes a one-hour~     small-group session for eight weeks for children and two 2-hour small-group sessions for~     parents. Baseline data will be collected before assigning the children to the intervention or~     control group. Follow-up data will be collected immediately after the intervention and 3~     months and 6-months post intervention. A repeated measures (longitudinal) design employing a~     linear mixed models approach will be used for analysis.~   "
231749|NCT00522951|"~     This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance,~     which has already been approved as a pharmaceutical product of similar indication.~   "
231750|NCT00522938|"~     This is an open-label, multicenter, multiple-dose, Phase I-II study of CHR-2797~     co-administered with erlotinib in patients with histologically or pathologically confirmed~     Stage IIIB (with pleural effusion), Stage IV, or recurrent metastatic NSCLC. Throughout this~     protocol, study medication includes both CHR-2797 and erlotinib.~      This study will involve 2 distinct study phases. Study Phase A will assess safety and~     determine the MTD of the combination of CHR-2797 and erlotinib. In addition, PK profiles for~     the combination of CHR-2797 and erlotinib will be evaluated. In Study Phase B, the dose~     chosen based on the maximum tolerated dose established in Study Phase A will be administered~     in a single-arm treatment design in order to evaluate the efficacy of co-administration of~     CHR-2797 and erlotinib.~   "
231751|NCT00522925|"~     The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and~     to see how safe PS433540 is compared to placebo.~   "
231752|NCT00522912|"~     Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by~     Chlamydia trachomatis causes a gradual scarring process of the inner surface of the eyelid~     (conjunctiva) leading to in-turning of the eyelids (entropion) and lashes touching the eye~     (trichiasis). The rate of progression and the severity of disease are variable. Some people~     develop severe disease with extensive entropion and trichiasis, whilst others have a mild~     problem with only a few lashes touching the eye, which does not progress.~      In more advanced cases there is a broad consensus that the entropion / trichiasis should be~     corrected by surgery. In mild cases (minor trichiasis: 1-5 lashes touching the eye) the~     optimal treatment is uncertain. Some advocate early surgery to turn the eyelid out for any~     individual with one or more lashes touching any part of the eye. Others consider this to be~     too early for surgical intervention, as surgery can have a high recurrence rate and~     complications can arise. Instead, they recommend that minor trichiasis can be managed by~     epilation (pulling out lashes with forceps). In many endemic regions the uptake of surgery is~     low, with many patients preferring to epilate for mild disease.~      The primary purpose of this study is to compare the outcome of immediate surgery to regular~     epilation for the management of minor trichiasis. The epilation would be done by a person~     with good eyesight using proper epilation forceps.~   "
231753|NCT00522899|"~     The primary objective of this study is to conduct a randomized, controlled trial to determine~     whether engaging in mental activity or exercise, either alone or in combination, improves~     cognitive function in non-demented, inactive older adults who self-report a recent decline in~     memory or thinking. In addition, we, the researchers at the University of California, San~     Francisco, plan to seek funding to follow subjects over time to determine whether these~     interventions are associated with changes in rate of cognitive decline or risk of dementia~     after the intervention period has ended.~   "
231754|NCT00522886|"~     To determine the MTD toxicity of standard dose cetuximab together with concurrent~     individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine~   "
231755|NCT00522873|"~     The study is designed to investigate the safety of the investigational product for the lining~     of the uterus (endometrium).~   "
231756|NCT00522860|"~     Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by~     Chlamydia trachomatis causes in-turning of the eyelids / lashes (trichiasis), leading to~     corneal damage and blindness. The WHO recommends corrective eyelid surgery for trichiasis.~     Unfortunately, trichiasis frequently returns following surgery. The purpose of this study is~     to compare the outcome of surgery (at one and two years) for trichiasis using two currently~     used alternative suture types: non-absorbable (silk) and absorbable (vicryl). We, the~     researchers, hypothesise that the supportive presence of the absorbable suture for a longer~     period produces more stable wound healing, leading to a better outcome.~   "
231757|NCT00522847|"~     The purpose of this study is to compare various symptoms and signs of dry-eye as well as~     stratify characteristics of the tear film in a group of dry-eyed individuals in comparison to~     a group of non-dry-eyed people. Dry-eye is a condition that significantly impacts the quality~     of life of the sufferer. These are people who are predominantly female and in the older age~     groups. Determining what characterises a person with dry-eyes is of importance to~     understanding the disease process.~   "
231758|NCT00522834|"~     Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical~     entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This~     response is characterized by increased production of gene families that protect against~     different cellular stresses, including excessive heat, the presence of reactive oxygen~     species such as oxygen radicals, or the presence of heavy metals.~      Subjects will participate in up to 2 weeks of screening during which time they will complete~     all screening procedures. Eligible subjects who have not received any prior cytotoxic~     chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either~     STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.~      One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest~     period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments~     will be performed every 8 weeks from the date of randomization or sooner if the Investigator~     suspects progression has occurred based on clinical signs and symptoms. ~   "
231759|NCT00522821|"~     There is no consensus on the treatment of patients with recurrent infections and isolated~     immunoglobulin G (IgG)-subclass deficiency and/or selective antipolysaccharide antibody~     deficiency. Therefore, the Dutch Inter University Working Party will start a study in which~     the treatment with antibiotics is compared with intravenous immunoglobulin therapy with~     respect to clinical outcome measures in both children and adults with this disorder.~   "
231760|NCT00522808|"~     The purposes of this study are:~        -  to determine the safety and tolerability of multiple doses of A-831 at various doses~        -  to determine how multiple doses of A-831 are distributed through the bloodstream~        -  to determine if A-831 reduces the amount of Hepatitis C virus in the blood~   "
231761|NCT00522795|"~     Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal~     Cancer: A Phase II Trial. (CTI#X64001~   "
231762|NCT00522782|"~     To study the improvement in airway inflammation in children with asthma non-invasively with~     exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg~     daily.~   "
232368|NCT00514735|"~     The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac~     Ablation System compared to medical therapy in the persistent and long-standing persistent~     atrial fibrillation population.~   "
231763|NCT00522769|"~     The claire project is a research study testing the use of Cognitive Behavioral Therapy (CBT)~     to help teenage girls develop healthier eating habits and better ways to manage weight and~     shape concerns. The study is enrolling girls who are members of the Kaiser Permanente Health~     plan in the Northwest region. They must be between the ages of 12 and 18 and report binge~     eating and/or purging (vomiting, laxative or diuretic use) at a research established~     threshold to be eligible for the study. Girls enrolled in the study will either receive the~     6-20 session CBT intervention at the time of enrollment or 6 months after they enroll.~     Assessments including questions about eating behaviors, mood, and general functioning are~     given on enrollment in the study, and 3- and 6-months following enrollment (also at 9- and~     12-months for those in the delayed treatment condition).~   "
231764|NCT00522756|"~     The purpose of this study is to determine whether sodium bicarbonate is effective in reducing~     kidney injury that may occur during cardiac surgery.~   "
231765|NCT00522743|"~     A 2-arms randomized open prospective intervention study to determine the Growth and metabolic~     response to growth hormone and gonadotropin-releasing hormone agonist treatment versus growth~     hormone alone in boys born SGA.~      All subjects will be treated with NorditropinSimplex at a dosage of 100mcg/kg/d.~      At onset of puberty, subjects will be randomized into either combined treatment with GH and~     GnRHa or GH alone.~   "
231766|NCT00522730|"~     The purpose of the study is to determine the tolerance on lipid metabolism and the safety of~     short-term parenteral nutrition as compared to enteral nutrition in critically ill patients~     with liver failure.~   "
231767|NCT00522717|"~     Patients recovering from coronary artery bypass graft (CABG) surgery have high rates of~     depression, and depression is associated with higher risk of complications and death. Recent~     discoveries show that depression involves changes in certain molecules in the blood, which~     are also involved in progressive coronary artery disease (CAD) and its complications. This~     study will evaluate the effects of cognitive behavioral therapy (CBT) as a treatment for~     depression on these biological markers among CABG patients.~   "
231768|NCT00522704|"~     The purpose of this study is to determine if Effective Extracorporeal Blood Flow(eEBF) has~     correlation with Access Blood Flow (Qa), when eEBF adjusts with Dynamic Arterial Line~     Pressure (DALP) in patients with Arteriovenous fistulae in hemodialysis treatment.~   "
231769|NCT00522691|"~     Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe fecal~     incontinence. The test stimulation is minimally invasive, associated to low morbidity and~     relatively cheap. On the contrary, implantation of the definite stimulator is related to~     higher morbidity and considerable costs. A careful patent selection for definite implantation~     is therefore crucial. However, indication for implantation is actually based only on the~     subjective criteria reported in the patients´ diary only. Patients and care providers are~     likely to overestimate the real effect of SNS leading to an unjustified overuse of this~     expensive device. It is therefore necessary to evaluate real efficacy of SNS during the~     testing phase in a unbiased setting in order to avoid unnecessary morbidity and costs.~   "
231770|NCT00522678|"~     GW685698X is a novel glucocorticoid receptor agonist that is being developed as an orally~     inhaled treatment for asthma. In previous studies inhaled GW685698X was administered as a dry~     powder containing either lactose alone or lactose and cellobiose octaacetate. However, future~     dry powder GW685698X formulations will contain lactose and magnesium stearate. This study~     will be the first administration of this new GW685698X dry powder formulation in man and will~     provide safety and tolerability data to support the further development of this formulation.~   "
231771|NCT00522665|"~     The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may~     increase efficacy for patients with metastatic colorectal cancer who progressed on prior~     chemotherapy. This approach is biologically directed to overall target the cancer cell at~     multiple levels, and potentially preventing chemotherapy and EGFR-therapy resistance.~   "
231772|NCT00522652|"~     This study is being conducted to determine the safety and biologic activity of PX-478, and to~     allow for observation of any preliminary evidence of antitumor activity in patients with~     advanced metastatic cancer.~   "
231773|NCT00522639|"~     The objective of the study is to investigate the evolution ofn 18F-deoxyglucose (FDG) uptake~     and the tumour characteristics determined in the plasma of patients with lung cancer of~     during and after concurrent radiotherapy and chemotherapy~   "
231774|NCT00522626|"~     This study seeks to elucidate fetal neurobehavioral development in fetuses of opioid~     dependent women who have either undergone and completed methadone detoxification,or who never~     received methadone maintenance, and are not methadone maintained at 36 weeks gestation. This~     research will determine how fetal neurobehavioral functioning in fetuses of opioid dependent,~     non-methadone maintained women differs from that of fetuses whose opioid dependent mothers~     are methadone maintained. The project will utilize a state-of-the-art computerized fetal~     actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart~     rate, the interaction between the two and maternal physiologic parameters.~   "
231775|NCT00522613|"~     The purpose of this study is to develop and evaluate a low-cost, joint~     consumer/counselor-led, health education and support intervention that will foster self-care~     and recovery among adults with serious mental illness. Results from the study will indicate~     how well the workbook and the overall program were received by individuals with serious~     mental illness, and whether participating in the program appeared to improve recovery and~     functioning.~   "
231776|NCT00522600|"~     This study will be used to evaluate how patients put eye drops in their eyes and any problems~     that may arise from this activity. The information gathered will help identify common~     problems patients are having with putting in their eye medications. Then doctors can be~     better informed about the issues and provide better advice to their patients to overcome~     these problems.~   "
231777|NCT00522587|"~     During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will~     be studied.~   "
231819|NCT00522015|"~     to show that~        1. patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory~          function~        2. use of rivastigmine has a positive effect on apathy in PSP patients~        3. therapy with rivastigmine has a no positive benefit on speech and overall results of the~          MMST~        4. changes in motor activity are associated with changes in language and overall results of~          the in MMST~   "
231778|NCT00522574|"~     The purpose of this study is to evaluate the safety and tolerability of XL019 in adults with~     myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2. JAK2~     is activated by cytokine and growth factor receptors and phosphorylates members of the STAT~     family of inducible transcription factors. Activation of the JAK/STAT pathway promotes cell~     growth and survival, and is a common feature of human tumors. JAK2 is activated by mutation~     in the majority of patients with myelofibrosis, polycythemia vera and essential~     thrombocytosis and appears to drive the inappropriate growth of blood cells in these~     conditions.~   "
231779|NCT00522561|"~     Inter-individual variability in energetic cost of running may be partly explained by lower~     limbs mechanical characteristics. The transposition of muscle mechanical model with two~     components (contractile and elastic) to the whole lower limb mechanical behavior analysis~     during running. The main aim of present investigation is to study the effects of lower limb~     mechanical characteristic (force, velocity, stiffness) on the energetic cost of running using~     a lower limb mechanical approach including both contractile and elastic components.Twenty~     healthy men will run on a treadmill at 12km.h-1 in 8 different 5 min-conditions. Through~     conditions, stride frequency, sole stiffness and subject's body weight will be changed to~     allow artificial variations in lower limb mechanical characteristics. Energetic and~     non-invasive mechanical measurements analysis will be performed to obtain energetic cost of~     running and to compute force, velocity and stiffness of lower limbs for each condition.~   "
231780|NCT00522548|"~     Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness~     to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients.~     However, enteric coated mycophenolate sodium has been thought to possibly be associated with~     fewer gastrointestinal side effects. Mycophenolate mofetil and enteric coated mycophenolate~     sodium pharmacokinetics (how the drug is absorbed and broken down) have not been well-studied~     in African American kidney transplant recipients. The investigators are interested in~     studying enteric coated mycophenolate sodium and mycophenolate mofetil pharmacokinetics and~     gastrointestinal side effects in African American kidney transplant recipients.~   "
231781|NCT00522535|"~     Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness~     of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of~     abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled~     aorta, angled aneurysmal body, or both, between 0° and 90°.~      Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free~     from endoleak, migration, and fracture at 12 months.~      Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to~     the 12 month, all cause mortality rate in the Open Control group.~      Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the~     Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30~     days post-operative in the Open Control group.~   "
231782|NCT00522522|"~     Naturalistic, multicentre, epidemiological study to evaluate the care services used during~     the process of diagnosis of any kind of epilepsy. Data about services since first seizure~     until confirmed diagnosis will be examined.~   "
231783|NCT00522509|"~     To assess the feasibility and results of liver resection after preoperative hepatic artery~     infusion (HAI) chemotherapy with FUDR.~   "
231784|NCT00522496|"~     The purpose of this study is to:~        1. Determine the temporal course of matrix metalloproteinase (MMP) expression in patients~          wiht severe traumatic brain injury~        2. Determine the temporal course of the expression of MMP-related inflammatory mediators of~          secondary injury in patients with severe traumatic brain injury~        3. Describe the association of physiological changes and standard microdialysis analyte~          measures (lactate, pyruvate, lactate/pyruvate ratio, and glucose) to MMP and~          neuroinflammatory marker concentrations.~   "
231785|NCT00522470|"~     We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in~     diabetic women.~   "
231786|NCT00522457|"~     This study has the purpose to demonstrate clinical efficacy of the investigational new drug~     ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu)~     overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (FISH) test~     result) metastatic breast cancer progressing after trastuzumab treatment.~      Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3~     on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy.~     This new antibody class has the capability to redirect T cells and accessory immune effector~     cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor~     site. According to preclinical data, trifunctional antibodies activate these immune cells,~     which can trigger a complex anti-tumor immune response.~   "
231787|NCT00522444|"~     Nebulized Magnesium Sulfate has been shown to be of benefit in adults with acute asthma~     exacerbations, though limited work has been done in the pediatric population. Current~     therapeutic questions include the effect of more than one dose of nebulized magnesium, the~     possibility of a sustained effect (greater than 20 minutes) after a treatment, the potential~     benefit in children younger than 5 years of age, and the use of an asthma score to re-assess~     patients after treatment with this medication. The purpose of this double-blind randomized~     placebo-controlled clinical trial is the evaluate the effect of multiple doses of nebulized~     magnesium sulfate versus saline in addition to standard asthma therapy on clinical asthma~     score and FEV1 in children 7 to 18 years of age with a moderate to severe acute asthma~     exacerbation. Our hypothesis is that nebulized magnesium sulfate, when added to traditional~     bronchodilator therapy, will improve acute asthma exacerbations more rapidly than standard~     therapy alone. The primary outcomes are asthma score and FEV1 values obtained after two~     nebulized magnesium sulfate compared to placebo treatments. This therapy will be supplemental~     to standard therapy of albuterol and ipratropium nebulized treatments and systemic~     corticosteroids. The secondary outcome is patient disposition (discharge home or~     hospitalization). Patients with known asthma will be approached for enrollment and informed~     consent obtained if the asthma score after the first albuterol treatment is 2 or greater.~     One hundred-seventy patients will be enrolled and randomized to either the treatment group or~     the placebo group. The change from baseline in asthma scores and FEV1 values will be compared~     among the control and treatment groups to assess for any benefit of the addition of nebulized~     magnesium sulfate to the treatment regimen.~   "
231788|NCT00522431|"~     Low testosterone is a condition that occurs when the body is unable to produce sufficient~     quantities of testosterone. The medical name for low testosterone is hypogonadism.~     Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of~     energy and mood swings. The goal of testosterone replacement therapy is to return~     testosterone levels to the normal range and relieve symptoms.~      The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to~     maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18~     to 75 years. This will be determined by blood sampling at specified times during the study.~     The study is also intended to evaluate the tolerability of Fortigel, which will be applied to~     the skin each day throughout the study period.~   "
231789|NCT00522418|"~     This is a post-market medical device study. This study will compare best medical practice~     with or without adjunctive VNS Therapy in patients who are 16 years and older with~     pharmacoresistant partial epilepsy.~   "
231790|NCT00522405|"~     Background Hepatocellular carcinoma, a malignant tumor of liver is one of the most common~     cancers worldwide. All India Institute Of Medical Sciences (AIIMS) being a tertiary care~     hospital receives about two to three cases of Hepatocellular carcinoma (HCC) each day in our~     Gastroenterology out patient department. Most of these patients present late when the disease~     is already advanced and no curative therapies can be offered. At this stage, palliative~     therapy forms the mainstay of treatment. This includes TACE or Oral chemotherapy. Whether~     oral chemotherapy administered along with TACE potentiates the effect and further prolongs~     survival, needs to be ascertained. No studies of this kind are available.~      This prospective study is therefore designed to address this issue.~   "
231791|NCT00522392|"~     This randomized phase III trial compares bortezomib, dexamethasone, and lenalidomide with~     bortezomib and dexamethasone to see how well they work in treating patients with multiple~     myeloma previously treated with dexamethasone. Bortezomib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in~     different ways and stop cancer cells from growing. It is not yet known whether giving~     bortezomib and dexamethasone is more effective with or without lenalidomide in treating~     multiple myeloma.~   "
231792|NCT00522379|"~     The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine~     used with L-dopa in treating advanced stage Parkinson's disease.~   "
231793|NCT00522353|"~     The purpose of this study is to determine if oligofructose supplementation promotes weight~     loss in overweight and obese adults.~   "
231794|NCT00522340|"~     An implantable cardioverter-defibrillator (ICD) is a small device that is surgically~     implanted in the chest or abdomen and uses electrical pulses or shocks to help control~     life-threatening, irregular heartbeats. Increasing aerobic exercise may provide health~     benefits to people with ICDs. This study will examine the effects of an exercise program on~     heart and lung function in people who have an ICD.~   "
231795|NCT00522327|"~     All new patients to the general medicine clinic who were not primarily English speaking were~     randomized, after consenting, to receieve either remote simultaneous medical interpreting or~     usual and customary interpreting services. Patient charts were followed for one year after~     enrollment to assess medical outcomes, including patient satisfaction, diabetes management,~     lipid management, depression screening and management, vaccine administration.~      All Spanish-speaking ER patients were similarly enrolled. They were followed for one ER visit~     and their knowledge of exit instructions was assessed, as well as their satisfaction with~     care.~   "
231796|NCT00522314|"~     This clinical trial is investigating the efficacy of Non Invasive Ventilation (NIV) as a~     method of airway clearance in patients with an acute exacerbation and moderate to severe~     bronchiectasis disease. Current treatment focuses on the use of Active Cycle of Breathing~     Techniques (ACBT) but this modality alone may not be sufficient when patients have more~     severe disease and an acute infection. The use of NIV may result in better patient care and~     more appropriate physiotherapy treatment in the more unwell population.The aim of this study~     is to compare the efficacy of two physiotherapy airways clearance interventions in~     bronchiectasis.~   "
231797|NCT00522301|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with~     ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in at least the second~     remission.~   "
231798|NCT00522288|"~     The purpose of the study is to determine whether contact lens wear will improve children's~     self-perceptions more than spectacle wear.~   "
231799|NCT00522275|"~     The purpose of this trial is to determine whether lacosamide is safe and effective for~     long-term use in patients with partial-seizures from epilepsy~   "
231800|NCT00522262|"~     The purpose of the ALPHA Trial is to examine the physiologic changes that occur in a woman's~     body when she begins exercising that may be related to a change in her risk of getting breast~     cancer.~   "
231801|NCT00522249|"~     The purpose of this study is to evaluate the combination of Pegylated Alfa Interferon~     (PEG-Intron), Sunitinib and Tarceva to see if this drug combination delays the disease~     progression of patients with metastatic Renal Cell Carcinoma. The first phase of this study~     will determine the best dose of Peg-Intron, Sunitinib and Tarceva when given in combination.~     The safety of giving these drugs in combination and response to treatment will also be~     examined.~   "
231802|NCT00522236|"~     To evaluate the antibody response to each influenza vaccine antigen when administering a~     single dose to subjects aged 65 years and over~   "
231820|NCT00522002|"~     To explore the hypothesis that leg ulcers are associated with hypercoagulable states, the~     CLUE study will evaluate patients with connective tissue disease associated leg ulcers, to~     identify risk factors (especially hypercoagulability and immunologic characteristics),~     characterize pathogenesis, predict response to therapy, and assess the impact of lower~     extremity ulcers on quality of life.~   "
232118|NCT00518102|"~     The purpose of this study is to compare the risk of cancers in patients who have used~     REGRANEX (becaplermin) to that of patients with similar characteristics and health issues who~     have not used REGRANEX (becaplermin). REGRANEX (becaplermin) is topical medication used to~     treat non-healing neuropathic foot ulcers in patients with diabetes.~   "
231803|NCT00522223|"~     Objectives:~      Primary Objectives:~      To assess the entire range of sexual functioning (desire, arousal, orgasmic capacity,~     dyspareunia, and sexual satisfaction) over the course of treatment and early follow-up in~     patients with local and locally advanced cervical cancer; To assess general cancer-related~     QOL over the course of treatment and early follow-up in patients with local and locally~     advanced cervical cancer; To characterize the relationship between sexual dysfunction and~     overall cancer-related QOL over time; and To identify factors that may predict better sexual~     function outcomes in patients treated for cervical cancer.~      Secondary Objectives:~      Describe vaginal changes objectively via measurement of vaginal length. Demonstrate~     reliability of the vaginal length instrument and its applicability to future studies.~   "
231804|NCT00522210|"~     The purpose of this study is to determine whether there is a difference in blood sugar~     control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin~     injections incorporating a new long acting insulin analogue (detemir) compared to children~     using their current three times a day insulin injections (with intermediate and rapid acting~     insulin).~   "
231805|NCT00522197|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of ACAPHA, a combination of six herbs, may prevent lung cancer from forming in former smokers~     with bronchial intraepithelial neoplasia.~      PURPOSE: This randomized phase II trial is studying the side effects and how well ACAPHA~     works in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia.~   "
231806|NCT00522184|"~     Intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a~     double-blind randomized study for evaluation of efficacy and safety of etanercept versus~     intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow)~   "
231807|NCT00522171|"~     The objective of this study is to determine if the use of The Harmonic™ (an ultrasonic~     surgical instrument) in Lower Body Lift procedures reduces volume and duration of wound~     drainage after surgery when compared to Electro Surgery.~   "
231808|NCT00522158|"~     We aimed to compare the effect of achieving an LDL-cholesterol <70 vs an LDL-cholesterol <100~     mg/dL with simvastatin or atorvastatin on adrenal and testicular steroidogenesis, and~     cognition in diabetic patients.~   "
231809|NCT00522145|"~     The purpose of this study is to determine the best confirmed response rate of daily~     administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and~     VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with~     either erlotinib or gefitinib.~   "
231810|NCT00522132|"~     The primary objective of the study is to evaluate the effectiveness of 2 intravenous~     artesunate dosing regimens (2.4 mg/kg initially and at 12, 24, 48, and 72 hours or 4.0 mg/kg~     initially and at 24 and 48 hours) in clearing P. falciparum parasites in children with severe~     malaria.~      Secondary objectives include:~        -  To compare the tolerability and safety of the 2 intravenous artesunate dosing regimens.~        -  To evaluate differences in the pharmacokinetic profile of intravenous artesunate by~          patient age and clinical presentation.~   "
231811|NCT00522119|"~     High blood pressure affects nearly one third of all individuals in the United States. It is~     believed that genetic factors may predispose some people to develop this disease. This study~     will identify and characterize variations in three genes known to play a part in the~     development of high blood pressure.~   "
231812|NCT00522106|"~     We performed a randomized controlled trial to study the effectiveness of Behavioral graded~     activity (BGA) in patients with OA of the hip or knee. It was hypothesised that in the long~     term BGA results in less pain, less limitations in activities, and better patient global~     assessment (i.e. the effect of treatment perceived by patients themselves), compared to usual~     care of physiotherapists (UC). UC was operationalized as physiotherapeutic care according to~     the Dutch physiotherapy guideline for patients with hip and/or knee OA. It was also~     investigated whether specific subgroups of patients benefited more from BGA and which factors~     influenced the success of BGA-treatment. Also, it will be investigated whether differences~     exist in exercise adherence and whether there is a relationship between exercise adherence~     and long-term effectiveness.~   "
231813|NCT00522093|"~     TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may~     activate bowel movement. This study will test the efficacy and safety of TJ-100 in the~     treatment of patients with chronic constipation.~   "
231814|NCT00522080|"~     Objective: To study the feasibility and validity of a two-step telephone screening procedure~     for symptomatic knee and hip osteoarthritis (OA) in the general population.~      Method: The screening questionnaire was based on signs and symptoms, previous diagnosis of~     OA, and validated OA criteria. A random sample of telephone numbers was obtained and, at each~     number, one individual aged 40 to 75 years was included. A physical examination and knee or~     hip radiographs were offered when the screen was positive. A sample of individuals with~     negative screens was also examined. The diagnosis of hip/knee OA was based on either American~     College of Rheumatology criteria for signs and symptoms and Kellgren-Lawrence radiographic~     stage 2 or greater. Prevalence rates were estimated with correction for the performance of~     the screening procedure.~   "
231815|NCT00522067|"~     This phase II, open label, is designed as a seasonal study to support annual strain update~     evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation~     of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic~     diseases~   "
231816|NCT00522054|"~     The purpose of this study was to study the impact of Tai Chi group exercise on physical~     function, health and disease activity of patients with RA, and to examine the patients'~     experience and perception of Tai Chi.~   "
231817|NCT00522041|"~     Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal~     pain especially during defecation and for 1 or 2 hours afterwards. There are no approved~     drugs in the United States (US) for this condition and surgery is often the treatment choice.~     Strakan is conducting this confirmatory study so the product can be submitted for regulatory~     approval in the US. Strakan currently markets this product throughout Europe.~      The objective of this study is to determine the effect of nitroglycerin ointment 0.4%~     (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21~     days of treatment in 250 patients.~   "
231818|NCT00522028|"~     The present study is a randomized, controlled trial that investigates the effects of~     parathyroidectomy or medical observation in mild asymptomatic pHPT on morbidity and quality~     of life (QoL).~   "
231821|NCT00521989|"~     CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug~     dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to~     work through a novel mechanism of action in which dipyridamole selectively amplifies the~     anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating~     the dose-dependent adverse effects.~      CRx-102 has been associated with clinical benefit in proof of concept studies in subjects~     with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA.~     It is considered a dose-finding study and will also compare the potential benefits of CRx-102~     treatment to both prednisolone administered alone and to placebo in this indication.~   "
231822|NCT00521976|"~     The main aim of this trial is to assess the long-term prognostic value of different types of~     Factor XIIa in an unselected, single center series of 871 chest pain patients admitted to the~     emergency unit, employing blood samples collected at admission.~      The second purpose of this study is to assess the incremental prognostic value of B-type~     natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP).~      A third purpose of this study is to evaluate the prognostic impact of the Omega-3 Index which~     is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to other~     fatty acids in the erythrocyte membrane.~   "
231823|NCT00521963|"~     Intra-articular (IA) injection of medication is a common procedure in the management of joint~     disorders. In particular, the procedure is effective in the treatment of inflammatory~     conditions, with long acting corticosteroids most commonly used. These agents have been shown~     to reduce the signs and symptoms of inflammation, expressed primarily in the synovium of the~     joint, and are probably capable of slowing the progression of damage to joint cartilage and~     bone in some of these inflammatory conditions. Arthritis that is refractory to IA~     corticosteroid injections may respond to surgical, chemical, or, radioisotope synovectomy,~     procedures in which the inflamed synovial tissue is eradicated. It has been noted that~     infliximab, a monoclonal antibody directed to Tumor Necrosis Factor (TNF) - α, has high~     affinity for the TNF-α rich inflamed synovium. Recently, clinical benefit from IA injections~     of infliximab has been reported in some cases that were refractory to IA injections of~     corticosteroids. Similarly, the effectiveness of IA infliximab in suppression of joint~     inflammation has also been demonstrated in patients who could not receive systemic therapy~     with infliximab. These reports examined the effect of a single injection of infliximab100 mg~     injected into a large inflamed joint or 2 IA injections 24 hours apart.~      We propose to further evaluate the use of IA infliximab in patients with intractable knee~     monoarthritis, explore the optimal mode of its employment, and assess the degree of~     infliximab systemic absorption from the IA injection. In a pilot study 40 knees will be~     evaluated, 20 injected with infliximab and 20 injected with a corticosteroid comparator~     reflecting the current standard of care.~   "
231824|NCT00521950|"~     The purpose of this study is to determine whether thiopurine S-methyltransferase (TPMT)~     genotyping prior to thiopurine use is cost-effective in patients with inflammatory bowel~     disease (IBD) in need of immune suppression.~      The study is designed to test the hypothesis that optimization of initial thiopurine dose~     based on pre-treatment TPMT genotyping will maximize treatment efficacy and minimize adverse~     drug reactions (ADRs) resulting in reduced costs.~   "
231825|NCT00521937|"~     It is estimated that 300 million people worldwide will have diabetes by the year 2025. About~     12 percent of those with diabetes will have had a foot ulcer, which is a major source of~     morbidity, concern, and cost.~      The foot ulcers are the leading cause of hospitalization among people with diabetes and often~     lead to amputation. The costs of treatment and the high morbidity and mortality associated~     with diabetic foot problems necessitate the need for a systemic approach to a foot ulcer~     management.~      Current local treatments of this type of ulcer are: dressings (hydrocolloids, alginate…), and~     growth factors. However modern dressings may not avoid infection and the results of the~     clinical studies are not significant in terms of complete healing rate or in terms of time to~     healing. Concerning growth factors, the only one whose therapeutic application made proof is~     the rhPDGF (Regranex®) with an increase in the number of ulcers completely healed at the~     twentieth week compared to placebo (50% and 35%, respectively).~      The advancement of tissue-engineering has made possible dermal replacement on human wounds to~     facilitate healing.~      A new sponge composed of collagen and glycosaminoglycans (chondroitins 4 and 6 sulphate),~     reticulated by ionic bonds with chitosan before freeze-drying, was developed in France. This~     sponge is a non-toxic product due to its non-chemical reticulation (ionic bonds),~     biocompatible and biodegradable processes, handling and storable easily.~      The objective of this study is to demonstrate that such a substitute, cellularized by~     functional allogenic fibroblasts, and complying with all safety conditions, enables to lead~     to healing of diabetic foot ulcers.~   "
231826|NCT00521924|"~     This Phase 3, randomized, open-label, multicenter study in rheumatoid arthritis (RA) patients~     with low disease activity (Disease Activity Score 28 [DAS28] >2.8 and <3.5) is being~     conducted to evaluate induction of remission by adding infliximab to pre-existing treatment~     versus no additional treatment. All subjects eligible for this study, aged >35 to <=65 years,~     will have a diagnosis of RA according to American College of Rheumatology (ACR) criteria, and~     will be offered additional treatment with infliximab. Prior to the start of treatment,~     subjects must be on a stable regimen of disease modifying antirheumatic drugs (DMARDs) for at~     least 3 months. Subjects will be randomized (1:1) to basic therapy with or without infliximab~     for a total duration of 38 weeks followed by a follow-up period of up to 6 months. Subjects~     randomized to basic therapy + infliximab will receive infliximab 3 mg/kg at Weeks 0, 2, 6,~     14, 22, 30, and 38. The primary objective of the study is to assess the rate of remission~     according to DAS 28 (<2.6) at the end of treatment (after 38 weeks). Safety assessments~     include the incidence of adverse events, serious adverse events, and clinically notable~     abnormal vital signs and laboratory values.~   "
231846|NCT00521664|"~     The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e.~     platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions~     compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without~     any sign of bleeding when the platelet count is below 10.000/µL). With the experimental~     transfusion strategy transfusions could be safely reduced when the study hypothesis can be~     proven. This is the first prospective randomized study on this topic.~   "
232119|NCT00518089|"~     The study will determine the safety and efficacy of gatifloxacin eye drops in patients with~     bacterial conjunctivitis~   "
231827|NCT00521911|"~     Depression is a common disorder among patients with a somatic illness admitted to the general~     hospital. Patients with depression do worse in terms of their somatic symptoms or functioning~     that those without depression. They also stay in the hospital for longer.~      That is the reason that we are interested to know whether patients with depression do better~     if their depression is recognised earlier and treated appropriately. We would like to find~     out which questionnaires are most suitable in clinical practice to help pick up patients with~     a depression. In addition, we would like to know whether a short-term psychological treatment~     of depression would be of any help. We hope to be able to show that this treatment would not~     only result in a reduction of depressive symptoms, but also in a better and quicker recovery~     of the somatic illness.~      The treatment will consist of 6 to 9 weekly sessions of one hour, conducted by a cognitive~     behavioural assistant. Initially, the treatment will take place in the hospital. When~     patients are discharged, treatment sessions will continue at home. The treatment will focus~     on things like recognising and challenging unhelpful thoughts, planning of activities, and~     testing out of predictions by setting up behavioural experiments. Three monthly booster~     sessions will be offered to help patients to maintain their gains and prevent relapse. We~     will reassess the symptoms of the patients at three and six months after the end of~     treatment.~   "
231828|NCT00521898|"~     To evaluate isolated Descemet membrane transplantation as a refinement of previous advanced~     techniques for corneal transplantation, like Descemet Stripping Endothelial Keratoplasty~     (DSEK)~   "
231829|NCT00521885|"~     A total of 50 patients >40 yrs of age with an expected hospital stay in the Medical Intensive~     Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The~     patient and study team will be blinded to which drug they are receiving (either Arixtra or~     Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive~     drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed~     by the study team approximately 30 days after discharge from the hospital.~   "
231830|NCT00521872|"~     This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology~     of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction.~        -  Trial with surgical intervention~   "
231831|NCT00521859|"~     Primary:~      Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell~     transplantation (HCT)~      Secondary:~        -  Describe the change in pharmacokinetic (PK) parameters with increasing doses of drug.~        -  Describe and estimate the frequency of > Grade 3 non-hematologic/non-infectious~          toxicities at the MTD.~        -  Report the efficacy of the regimen.~        -  Evaluate the rate of engraftment for the regimen.~   "
231832|NCT00521846|"~     The purpose of this prospective clinical data collection is to document the performance and~     clinical outcomes of the ExploR Modular Radial Head.~   "
231833|NCT00521833|"~     To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and~     intraocular lens implantation using temporal versus nasal clear corneal incisions.~   "
231834|NCT00521820|"~     The purpose of this study is to compare the safety of Pioglitazone, once daily (QD), to~     Glyburide in Type 2 Diabetes Subjects with Mild to Moderate Congestive Heart Failure~   "
231835|NCT00521807|"~     Objective: The study was performed to evaluate the effect of a standardized hypnosis~     treatment used in general practice for patients with chronic widespread pain (CWP).~      Design: A randomized control group-controlled study. Setting and subjects: 16 patients were~     randomized into a treatment group or a control group, each constituting eight patients. Seven~     patients in the treatment group completed the schedule. After the control period, five of the~     patients in the control group also received treatment, making a total of 12 patients having~     completed the treatment sessions.~      Intervention: The intervention group went through a standardized hypnosis treatment with ten~     consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on~     ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy.~      Main outcome measures: A questionnaire was developed in order to calibrate the symptoms~     before and after the 10 weeks period, and the results were interpolated into a scale from 0~     to 100, increasing numbers representing increasing suffering.~   "
231836|NCT00521794|"~     Andersen-Tawil Syndrome (ATS) is a rare, genetic disorder that causes episodes of muscle~     weakness, potentially life-threatening changes in heart rhythm, and developmental~     abnormalities. Disease symptoms can vary, the cause of some ATS cases remains unknown, and no~     specific treatment has been identified. The purpose of this multi-site study is to better~     characterize ATS, establish whether symptoms change over time, and determine if symptoms are~     related to a mutation in the KCNJ2 gene.~   "
231837|NCT00521781|"~     The purpose of the clinical trial is to assess the clinical benefit as measured by time to~     tumor progression of Abraxane plus hormonal therapy when applied to previously untreated~     patients with unresectable or metastatic adenocarcinoma of the prostate, as well as to assess~     safety and tolerability of the study drug regimen and to evaluate secondary efficacy~     endpoints such as overall survival and duration of response.~   "
231847|NCT00521651|"~     This protocol is a sub-study of the ongoing Protect Health and Reduce Cancer Risk study~     conducted in Shanghai, China, and sponsored by the Shanghai Cancer Institute, Vanderbilt~     University, and the National Cancer Institute. The parent study is designed to examine the~     relationship of diet, lifestyle, occupational, and environmental risk factors, as well as~     genetic variation, to cancer incidence in a large cohort of men in women between 40 and 70~     years of age. The current sub-study will assess the validity and reliability of a new~     physical activity questionnaire for use in the parent study and to evaluate whether different~     types of activity and the frequency, intensity, and duration of activity are associated with~     markers that have been linked to cancer risk, such as C-reactive protein, interleukin 6 and~     soluble tumor necrosis factor alpha.~      Participants in the current 12-month study are selected from among men and women~     participating in the Protect Health and Reduce Cancer Risk study. Participants keep a diary~     of their physical activity and complete two 30-minute interviews about their physical~     activity, one at the beginning and one at the end of the study period. Every 3 months for 7~     consecutive days, they wear a pager-sized activity monitor on their waist that records their~     physical activity patterns during that period of time. They provide blood and urine samples~     four times during the study and, at the end of the study, undergo a health examination that~     includes an electrocardiogram, body composition measurement, and physical fitness test. The~     fitness test is a step-test consisting of 3-minute stages in which the subject successively~     increases the stepping speed until reaching 85 percent of his or her predicted maximal heart~     rate.~      Blood and urine samples are analyzed for levels of nutrients and certain proteins, and are~     stored for future studies related to nutrition and physical activity and possibly for genetic~     studies related to health, nutrition, exercise, or disease.~   "
232131|NCT00517920|"~     Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)~   "
231838|NCT00521768|"~     Introduction: Efforts to bridge the gap between research based treatment modalities~     advancements and clinical practice have received the highest priority in the research~     community. In the child psychiatry field there is an urging need to promote bridging this~     gap.~      Parents and child health providers hesitate to refer children to child psychiatrist due to~     stigma but also due to lack of awareness of available and efficient treatment options. In the~     field of trauma treatment another reason for lack of treatment is lack of recognition of~     trauma related symptoms in children.~      After the second Lebanon war scarce referrals to psychiatric clinics have been registered and~     access to treatment is low as indicated by 20 referrals in the past year to Emek Hospital.~      We propose to explore the effectiveness of well-established adult treatment for PTSD, the~     Prolonged Exposure (PE), in community-based general pediatric clinics, serving an~     underprivileged diverse population.~      Methods:~      Twenty children age 6 to 18 attending general pediatric clinic and in Afula region will~     included.~      children will be diagnosed using the Hebrew translation of the Childhood version of the~     Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989 Children will receive~     the Children's Depression Inventory (CDI) and the. CPSS All subjects will be treated with a~     manualized 12-week Prolonged Exposure protocol Ratings will be made at baseline, 6weeks, and~     12 weeks using CDI and CPSS~      Hypothesis:~      1. PE adapted for pediatric population will be effective in treating single-event traumas in~     a community setting.~   "
231839|NCT00521755|"~     The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB~     system for soft tissue bonding.~   "
231840|NCT00521742|"~     The purpose of this study is to evaluate the cardiovascular effects of pioglitazone, once~     daily (QD), versus glyburide when administered to patients with type 2 diabetes mellitus and~     mild cardiac disease.~   "
231841|NCT00521729|"~     This study will examine how body metabolism adjusts to small changes in environmental~     temperature and how it may be related to weight loss.~      Healthy, non-obese individuals between 18 and 60 years of age may be eligible for this study.~     The study consists of one screening visit and one 5-day admission to the NIH Clinical Center~     for the following procedures:~      Diet: Participants follow a proscribed diet consisting of 50% carbohydrates, 20% protein and~     30% fat.~      DEXA scan to measure body fat. Subjects lie on a table above a source of X-rays while a very~     small dose of X-rays is passed through the body.~      Air displacement plethysmography (Bod-Pod) to study fat composition: Subjects sit in a small~     booth for 10 minutes wearing a swim suit and breathing normally through a tube. This test~     measures the person s weight and volume precisely.~      Metabolic room: Subjects stay 12 hours in a specialized room designed to measure the amount~     of oxygen breathed in and the amount of carbon dioxide breathed out. The room contains a~     private toilet and sink, treadmill, bed, desk, window, telephone and computer with television~     and internet access. While in this room, subjects undergo the following:~        -  Continuous heart rate monitor: Subjects wear an EKG monitor to analyze heart rate~          variability.~        -  Spontaneous movements: Subjects wear portable accelerometers at the hip and wrist to~          measure spontaneous physical movements.~        -  Continuous temperature monitor: Subjects swallow a small capsule that transmits internal~          body temperature via miniature, wireless sensors. Adhesive patches placed on the skin~          monitor external body temperature.~        -  Blood and urine collections: Subjects collect all of their urine during the 12 hours~          they are in the metabolic room. Blood samples are taken at specified intervals through a~          catheter that has been placed in a vein.~        -  Microdialysis: A small needle is placed into fat tissue just under the skin on the~          abdomen. A solution containing a minimal amount of ethanol is infused and samples of~          fluid are collected every 20 minutes as it leaves the fat pad. This helps determine the~          metabolism level. This procedure starts 30 minutes before entering the metabolic room~          and continues until the subject leaves the room.~      Fat tissue biopsy: A small piece of fat tissue is withdrawn through a needle from under the~     skin on the abdomen. The sample is used to study fat tissue size and ability to store sugar.~   "
231842|NCT00521716|"~     The purpose of this study is to determine the safety and efficacy of using WaisFix100i device~     for Intracapsular Femoral Fracture Fixation.~   "
231843|NCT00521703|"~     There is some controversy in the medical literature regarding the effectiveness of topical~     lidocaine in children as an adjuvant drug to upper gastrointestinal endoscopy. In children,~     deep sedation and general anesthesia are often used to sedate children submitting to this~     procedure. Propofol is an anesthetic drug increasingly popular in this situation, but this~     drug can only be used with an anesthesiologist in Brazil. Its main side effects include~     hypotension, respiratory depression and local pain. Lidocaine is frequently used as~     premedication, and the rationale is that lowering patient discomfort could lower the required~     dose to achieve the endoscopy and reduce potential side effects. Nevertheless, some patients~     perceive this medication as uncomfortable. This study aims to compare sedative drug doses~     between patients who were given either placebo or topical lidocaine.~   "
231844|NCT00521690|"~     The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin~     detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD~     with/without once-daily NPH Insulin treatment.~   "
231845|NCT00521677|"~     Patients on ventilator are in high risk to develop ventilator associated pneumonia (VAP).~     This acquired infection significantly increases morbidity and mortality of these patients.~      Studies that investigated the factors influencing the incidence of VAP proved that infectious~     agents located in the throat and oral cavity are important factors.~      The assimilation of oral cavity treatment, including teeth brushing, cleaning and removal of~     secretions may significantly decrease the incidence of VAP. Choosing the method of oral~     cavity cleaning is based on few studies that demonstrated the optimal influence of combining~     mechanical cleansing, the use of a non alcoholic antiseptic material and lubrication of the~     lips and the oral cavity. Most of these studies are retrospective. The study will compare the~     traditional method of oral cavity treatment with the use of protocol that use special suction~     connected toothbrush to clean the teeth and the oral cavity, use of non alcoholic antiseptic~     solution and lubrication of the lips and the oral cavity.~      The current study is a prospective, open label, statistically balanced study that will~     investigate the connection between the method of oral cavity treatment and the incidence of~     VAP. 100 patients will be included.~      All ventilated patients in the ICU will be eligible and will be included after an informed~     consent will be signed by the patient, or by his legal guardian. Exclusion criteria include~     age less than 18 y/o, pregnancy, expected survival of less than 48 hours, immunosupression~     (excluding patients on steroids), severe burns, existing pneumonia and patient already~     included in another study.~      The main outcome will be 30 days all cause mortality. Secondary outcomes include the~     development of VAP, days on ventilator, LOS in the ICU and LOS in the hospital.~   "
231863|NCT00521443|"~     Various morphological abnormalities of human oocytes were reported to detrimentally affect~     embryo development. We observed development of frozen thawed embryos derived from oocytes~     with normal or abnormal morphological features to the blastocyst stage. Cytoplasmic~     abnormalities of the oocytes were found to negatively affect cryosurvival potential of the~     embryos.~   "
231848|NCT00521638|"~     This is a study to evaluate the safety and efficacy of TRU-015 in treatment of B-cell~     Non-Hodgkin's Lymphoma (NHL).~      TRU-015 is also currently being evaluated in multiple clinical studies for the treatment of~     autoimmune disorders. Over 300 patients have received TRU-015 in these studies, and the data~     observed to date support its safety in patients with autoimmune disorders.~      Safety of an escalating dose of 4 weekly infusions of TRU-015 will be evaluated in subjects~     with relapsed NHL (see inclusion criteria for subtypes).~      Once a maximum tolerated dose (MTD) is confirmed or maximum dose to be studied is determined~     to be safe and well tolerated, an expanded cohort of subjects with relapsed follicular NHL~     will be evaluated for efficacy.~   "
231849|NCT00521625|"~     PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in~     children with an acute lung injury (ALI). The objective of the study is to describe~     mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily~     clinical practice is heterogenous among pediatric intensivists as few pediatric data exists~     on optimal mechanical ventilation strategies in this group of patients. Furthermore,~     different strategies may affect patient outcome.~   "
231850|NCT00521612|"~     Two groups of patients are going to have abdominal surgery with low-flow general anaesthesia.~     Group A (sevoflurane group, experimental group) will use volatile anaesthetic sevoflurane.~     Group B (isoflurane group, control group) will use volatile anaesthetic isoflurane. It will~     be observed differences between volatile anaesthetic sevoflurane and volatile anaesthetic~     isoflurane for providing low-flow general anaesthesia for abdominal surgery. Duration of this~     randomised controled trial will be approximately 2 months. Estimated sample size will be 82~     persons (41 in sevoflurane group and 41 in isoflurane group).~   "
231851|NCT00521599|"~     This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone~     furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers,~     preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation~     of MF DPI 200 mcg twice daily in corticosteroid-dependent asthmatic subjects. The objective~     of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs~     when providing the same total daily dose (400 mcg/day).~   "
231852|NCT00521586|"~     This study is to evaluate the safety, tolerability and immune response when 13-valent~     pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are~     given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal~     polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also~     evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of~     13vPnC given 5 years after the first dose.~   "
231853|NCT00521573|"~     The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark~     chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in~     heart transplanted patients.~   "
231854|NCT00521560|"~     Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous~     application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation~     in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma~   "
231855|NCT00521547|"~     Acupuncture may affect nerve functions. This study assesses the effect of acupuncture on both~     the peripheral and the central nerve systems~   "
231856|NCT00521534|"~     Background and Introduction:~      SDB is increasingly recognized as a co-morbidity with significant impact on overall health.~     The disorder has been implicated in the development of hypertension, atherosclerotic~     cardiovascular disease as well as arrhythmia, stroke and the progression of congestive heart~     failure. The disorder is prevalent among males, estimated to affect upto 24% of the general~     population. Its prevalence increases with age, and it is particularly prevalent among~     patients with congestive heart failure with the prevalence rising to 51% in that group.~     Interestingly, recent evidence points to a potential impact for treating sleep disordered~     breathing, on heart failure patients. At the same time, recent reports of a beneficial impact~     of atrial overdrive pacing on SDB, have stirred interest in a potentially effective and well~     tolerated non-pharmacologic means of therapy for this disorder. Particularly at a time when~     cardiac resynchronization therapy utilizing biventricular pacing has demonstrated significant~     impact on heart failure, the interplay between CHF and SDB pacemaker based therapy begs~     further exploration. The interdependence of potential positive impact on each entity needs to~     be elucidated for further research and refinement of therapeutic tools. Furthermore, this~     study aims to explore potential neurohormonal influence on and affection by each of these~     disorders.~      Specific Aims and Hypotheses:~      Specific Aim #1: To assess the effect of cardiac resynchronization therapy (CRT) with or~     without atrial pacing on SDB in patients with advanced CHF at 8 and 16 weeks after~     implementation of therapy.~      Hypothesis #1: Resynchronization therapy improves SDB, the effect may anticipate or lag~     improvement in heart failure. Atrial pacing has a beneficial effect in addition to CRT.~      Specific Aim #2: To explore the effect of CRT on cardiac neuro-hormonal activity in relation~     to its effects on CHF and SDB.~      Hypothesis #2: CRT neuro-hormonal modulation is a common path in its effects on SDB and CHF.~      Specific Aim #3: To assess prevalence of sleep disordered breathing (SDB) in patients with~     advanced congestive heart failure (CHF).~      Hypothesis #3: SDB is prevalent yet under recognized in this patient population.~      Research Design:~      This is an observational study with a built in double blinded prospective randomized~     interventional substudy of a potential confounder i.e. atrial pacing. All patients will~     receive CRT with defibrillator for clinical indications (CRT-D). Investigators other than the~     EP physicians as well as patients will be blinded to the pacing mode. After screening and a~     run in period of back up pacing a baseline polysomnogram (PSG) will be performed. Patients~     will be randomized between atrial overdrive or atrial tracking pacing modes for six months,~     all patients receiving CRT. Sleep studies will be performed at baseline and at three month~     intervals. Subjects: Patients referred for implantation of CRT -D will be recruited for this~     trial. Patients are included only if they are indicated for such a device on clinical~     grounds. Outcome Measures: 1.Sleep quality related Parameters:The following will be collected~     at times of each PSG: MAP-PSQI, PSG parameters of sleep quality and architecture, apnea~     hypopnea index, and oxygen saturation as well as biochemical markers of sleep efficiency.~     2.Heart Failure Parameters: The following will be obtained at times of each PSG: Minnesota~     Living with Heart Failure Questionnaire, Clinical and echocardiographic measures of heart~     failure progression and biochemical markers of heart failure severity.~      Power Analysis: An improvement in SDB in both initial randomization arms is assumed, however~     we further assume the atrial overdrive arm will offer improvement over the atrial tracking~     arm of equal magnitude. An arbitrary estimate would be twenty percent improvement in atrial~     overdrive arm. The corresponding estimate is 40% improvement due to CRT. To achieve 0.80~     power thirty four data sets need to be collected.~   "
231857|NCT00521521|"~     To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or~     without cisplatin in terms of objective response rates (WHO criteria).~   "
231858|NCT00521508|"~     Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the~     pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental~     in suppressing adaptative immune responses, including B cells production of immunoglobulins.~     We, the researchers at Centre Hospitalier Universitaire de Saine Etienne, will test the~     hypothesis that IgA production in patients with IgA nephropathy is dysregulated because of a~     quantitative and/or qualitative defect of CD4+CD25+FoxP3+ regulatory T cells.~   "
231859|NCT00521495|"~     The purpose of this Phase II study is to assess the feasibility of conducting a large scale~     trial which will evaluate the effectiveness of static magnetic field therapy as a treatment~     for Carpal Tunnel Syndrome. This preliminary study will determine which of three strength~     magnets to use in the future.~      Participants will be recruited from three primary sources. 1) Patients with a possible~     diagnosis of Carpal Tunnel Syndrome who have been referred to the Orthopaedic and~     Rehabilitation Clinics of OHSU for Nerve conduction studies. If after conducting these~     studies a potential participant shows evidence of mild to moderate Carpal Tunnel Syndrome~     s/he will be informed about the study and invited to participate in additional screening. B)~     Patients seen at the National College of Natural Medicine (NCNM) Clinics who have a clinical~     diagnosis of Carpal Tunnel Syndrome will be informed about the study and invited to enter the~     screening process for further eligibility. C) Participants will also be recruited from the~     general public including staff and students at OHSU and NCNM).~      Eligibility will be determined through a stepwise process including telephone screening for~     general eligibility, Nerve Conduction screening for electrodiagnostic eligibility, and Boston~     Carpal Tunnel Questionnaire screening for symptom severity eligibility. Those potential~     participants who meet all eligibility requirements will be randomized to one of three~     magnetic field dosages. They will be provided with a ¾ diameter x 1/8 thick magnet which~     they will be required to apply for six weeks during the hours of sleep. Over the course of~     the study participants will have four visits to the General Clinical Research Center of OHSU~     and three visits to the Orthopaedic and Rehabilitation Clinics of OHSU for Nerve Conduction~     studies to be performed by either Dr. Nels Carlson or Dr. Hans Carlson.~      Questionnaires to be completed during the course of the study include a general health~     information and demographics questionnaire, the Boston Carpal Tunnel Questionnaire, which~     will be completed on six occasions, a general symptoms checklist and a Post Treatment~     Participant satisfaction questionnaire.~      Recruitment, retention, compliance and safety will be analyzed using descriptive statistics.~     Effectiveness of the three different strength magnets will be assessed by comparing~     participants' baseline scores on the Boston Carpal Tunnel Questionnaire with their scores~     after six weeks of magnet use.~   "
231860|NCT00521482|"~     The aim of this study is to evaluate the efficacy and safety of intensive dose temozolomide~     treatment alone in parallel to a combination with thalidomide in patients with recurrent~     glioblastoma after standard therapy.~      In the treatment arm A of the study it will be investigated whether or not continuous dosing~     of temozolomide may overcome alkylator resistance in patients with glioblastoma who progress~     on the 5/28 day dosing regimen.~      For treatment arm B it is postulated that the combination of thalidomide and temozolomide is~     effective with respect to time to progression and progression-free survival due to the fact~     that temozolomide and thalidomide have different mechanisms of action.~   "
231861|NCT00521469|"~     To determine the effects of instrument-applied chiropractic manipulative therapy (CMT) on~     postural control.~   "
231862|NCT00521456|"~     This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the~     treatment of inflammation and pain associated with cataract surgery~   "
232173|NCT00517374|"~     To establish a solid foundation, e.g. a network and a coordinating centre for testing new SCI~     therapies in forthcoming randomised controlled multi-centre clinical trials following~     international standards and guidelines.~   "
231864|NCT00521430|"~     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of~     cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the~     donor's stem cells. When the healthy stem cells from a donor are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets. Sometimes the transplanted cells from a donor can make an immune response~     against the body's normal cells. Giving cyclosporine and methotrexate before and after~     transplant may stop this from happening.~      PURPOSE: This clinical trial is studying the side effects and how well donor stem cell~     transplant works when given after conditioning therapy in treating patients with hematologic~     cancer, recurrent or metastatic solid tumor, or other disease.~   "
231865|NCT00521417|"~     A primary goal of this study is to investigate the significance of treatment duration, by~     comparing change after group psychotherapy of varying lengths. A secondary goal is to~     investigate the predictive value of selected patient variables on outcome: personality~     pathology, quality of object relations, presence of personality disorder, degree of initial~     disturbance, and education. One hundred and twenty patients from 5-6 different study sites~     (consisting of one coordinator and 3 therapists) will be included. Exclusion criteria are~     psychosis, substance abuse, and organically based symptoms. Patients are interviewed before~     treatment and one year after termination, and self-rated outcome measures are filled in at~     3-month intervals during treatment and at termination. After an initial evaluation, patients~     are randomized to one of two manualized psychodynamic group psychotherapies with different~     treatment lengths (20 and 80 sessions). Each therapist will conduct both a short- and a~     long-term group, and sessions are taped in order to check treatment integrity.~   "
231866|NCT00521404|"~     Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to~     subjects with previously untreated and unresectable (unable to be surgically removed) or~     metastatic (spread to other areas beyond the pancreas) pancreatic cancer.~   "
231867|NCT00521391|"~     Including a tailored moderate-intensity physical activity intervention in a standard smoking~     cessation treatment program (pharmaceutical treatment and counseling) increases the chances~     of quitting and reduces nicotine withdrawal symptoms, negative moods, stress, and weight~     gain.~   "
231868|NCT00521378|"~     A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.~   "
231869|NCT00521365|"~     The primary purpose of the study is to assess the efficacy of Quetiapine extended release~     600mg per day either as monotherapy or combined therapy in the treatment of patients with~     mania associated to Bipolar disorder. This trial will also assess the life quality and~     productivity loss improvement for patients from baseline to day 21.~   "
231870|NCT00521352|"~     This study will evaluate the efficacy of 1-Hz rTMS applied to the right Dorsolateral~     Prefrontal Cortex (DLPFC) in patients with Panic Disorder (PD) and comorbid Major Depressive~     Disorder (MDD) who have not fully responded to conventional therapies.~      The investigators hypothesize that:~        1. compared to sham (placebo), active rTMS will improve symptoms of PD and MDD as assessed~          with the Panic Disorder Severity Scale (PDSS), Hamilton Depression Rating Scale (HDRS),~          and Clinical Global Impression (CGI);~        2. active (but not sham) rTMS will normalize levels of motor cortex excitability relative~          to pre-treatment baseline.~   "
231871|NCT00521339|"~     The study will test the safety and tolerability of Apremilast twice a day in participants~     with recalcitrant plaque type psoriasis.~   "
231872|NCT00521326|"~     The purpose of this study is to evaluate the feasibility of acquisition of coronary blood~     flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and~     to evaluate the diagnostic power of the transthoracic Doppler analysis package for detecting~     and estimating the degree of coronary artery stenosis. Finally we hope to optimize the~     currently available analysis package on the basis of the comparison of the Doppler with the~     angiographic stenosis results and evaluation.~   "
231873|NCT00521300|"~     The purpose of this study is to investigate whether 6 months preoperative treatment with the~     somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.~   "
231874|NCT00521287|"~     According to a survey from Department of Health in 2004, cancer has been the leading cause of~     death in the Taiwan area. In 2004, people died of cancer, accounting for 27.2 percent of all~     deaths. The major reason of the superior grade is that cancer has the ability to escape the~     surveillance of immune system. It is also a main issue to address in medical research.~      Dendritic cells (DCs), the most potent APC, are located at sites of pathogen entry, acquire~     antigens from pathogens or pathogen-infected cells, and process these antigens for both class~     I and class II presentation. Upon antigen encounter, they termed immature DCs, undergo a~     maturation process, they are capable to present captured antigens to T cells. This maturation~     step allows DC migration to trigger adaptive immune responses. These features make DCs very~     good candidates for therapy against various pathological conditions including malignancies.~      Therefore, two concepts in this project will be concerned: one is enhancement of T cell~     immunity and the other is improvement of the efficiency of DC-tumor fusion. The strategy of~     enhance T cell is using well-known cytokines, such as IL2, and IL7 to expand the~     tumor-specific CD4 and CD8 T cells before DC-vaccine treatment. In the past, scientists~     utilized polyethyleneglycol to fuse cancer cells and dendritic cells. However, the results~     were devastating. Two new approaches of the DC vaccine will be applied to this study:~     DC-tumor fusion and DC phagocytosed apoptosed tumor cells. Whole tumor cells will be fused~     with DCs by combining hypotonic buffer and electrical-based fusion protocols. The safety of~     hybrid cell vaccination has been shown in clinical trials with some encouraging anti-tumour~     effects. However, data are as yet insufficient to assess a clear therapeutic benefit.~     Hopefully, the combination of two strategies will improve the efficiency of DC vaccine and~     boost survival of cancer patients.~      As we have gained a clearer understanding of the cellular and molecular events that modulate~     antigen presentation and T cell activation in vivo, new strategies have emerged, allowing the~     development of more potent second generation DC vaccines.~   "
231875|NCT00521274|"~     The purpose of this study is to evaluate the role of combination therapy with Trovax plus~     Docetaxel or Docetaxel alone in patients with prostate cancer with a rising prostate specific~     antigen (PSA).~   "
231885|NCT00521144|"~     This phase I/II trial is studying the side effects and best dose of obatoclax mesylate when~     given together with topotecan hydrochloride and to see how well they work in treating~     patients with relapsed or refractory small cell lung cancer or advanced solid tumors.~     Obatoclax mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving obatoclax mesylate together with topotecan hydrochloride may help~     kill more tumor cells~   "
231886|NCT00521131|"~     Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic~     Rhinitis to House Dust Mites~   "
231876|NCT00521261|"~     RATIONALE: Giving high doses of chemotherapy before a donor stem cell transplant helps stop~     the growth of cancer cells. It also stops the patient's immune system from rejecting the~     donor's stem cells. Colony stimulating factors, such as aldesleukin and GM-CSF, may increase~     the number of immune cells found in bone marrow or peripheral blood and may help the immune~     system recover from the side effects of chemotherapy. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Giving an infusion of the donor's T cells that have been treated with antibodies~     after the transplant may help increase this effect. Sometimes the transplanted cells from a~     donor can also make an immune response against the body's normal cells. Giving tacrolimus and~     mycophenolate mofetil after transplant may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects and best dose of donor T cells given~     together with low-dose aldesleukin and low-dose GM-CSF after donor stem cell transplant in~     treating patients with relapsed or refractory non-Hodgkin's lymphoma.~   "
231877|NCT00521248|"~     Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid~     drugs prior to birth. Commonly used treatments at present include morphine or tincture of~     opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been~     used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual~     (under the tongue) buprenorphine is able to be used safely and easily in newborns with the~     neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine~     is associated shorter stays in the hospital and fewer days of treatment than the use of~     standard therapy. Another secondary goal will be to understand buprenorphine concentration in~     the blood of babies treated with the drug (this is called pharmacokinetics).~   "
231878|NCT00521235|"~     The aim of the study is to validate the sanitary consequences of dental studies respectively~     the longtime executed profession. In comparison to this cohort we will also check a~     collective of subjects with an optimum of physical activity.~   "
231879|NCT00521222|"~     The investigators are conducting a study of asthma patients who use fluticasone with~     salmeterol (Advair) or any other combination of an inhaled corticosteroid (ICS) and a long~     acting beta agonist (LABA) to manage their asthma symptoms.~      Participants begin the study by continuing to use fluticasone with salmeterol or substituting~     fluticasone with salmeterol for their current ICS/LABA medication at their regular dose or~     the comparable dose(all study medications are provided) for a six-week period. Patients are~     then separated into 2 groups: one group is asked to use fluticasone (Flovent), the other to~     use fluticasone with salmeterol , twice daily over a 16-week period (patients will need to be~     seen monthly during this time). Neither study personnel nor patients will know which drug is~     being used.~      Patients are also asked to use a peak flow meter and record their daily results on a form,~     along with the number of puffs they use of their rescue inhaler each day. They also record~     any changes in asthma medications and information on any asthma episodes.~      The investigators hypothesize that there are certain patients with asthma who will do better~     when a long acting beta agonist is removed from their maintenance asthma medications.~   "
231880|NCT00521209|"~     RATIONALE: Clinic-based health programs may be effective in improving the diets and physical~     activity levels of low-income, uninsured participants in Los Angeles County, California.~      PURPOSE: This randomized clinical trial is studying a patient-directed lifestyle change and~     health promotion program to see how well it works compared with usual care in low-income,~     uninsured participants in Los Angeles County, California.~   "
231881|NCT00521196|"~     The purpose of this study is to determine whether a painless and noninvasive procedure called~     Transcranial Direct Current Stimulation (tDCS) can be an effective therapy for the treatment~     of migraine and migraine-associated pain.~      Stimulation of the motor cortex with tDCS has already been shown to relieve pain in patients~     with other chronic pain syndromes, including traumatic spinal cord injury and fibromyalgia.~     Patients with migraine are usually extremely sensitive to pain. A treatment that targets the~     areas of the brain that are related to the experience of pain may also help decrease pain in~     patients with migraine. Pain control with this localized approach may help avoid the problems~     due to pain medications that affect all organs in the body.~      We hypothesize that 10 sessions of Transcranial Direct Current Stimulation (tDCS) applied~     over the area of the brain that controls pain and motor function will decrease pain and~     headache frequency in patients with migraine.~   "
231882|NCT00521183|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as~     cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when~     given together with tetrahydrouridine and external-beam radiation therapy in treating~     patients with cancer that has spread to the brain.~   "
231883|NCT00521170|"~     Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal~     and flare reaction.~   "
231884|NCT00521157|"~     The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants~     as relapse prevention for patients that are completing treatment for opiate addiction in~     inpatient (or similarly controlled) settings. Participants volunteer for the study before~     being released from inpatient treatment, and are randomized to a naltrexone implant group or~     a waiting-list control for the duration of the first six months following completion of~     inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the~     Norwegian healthcare system. After six months, both groups will be offered to have naltrexone~     implanted for the remaining six months of the study.~      The hypotheses are that quality of life, depression, opioid use, will be significantly better~     in the naltrexone group compared to the non at 6-month follow-up. For the last six months of~     the trial, the investigators hypothesise that choice of naltrexone implant will mainly~     strengthen positive tendencies or reverse negative trends on the aforementioned variables.~      The investigators also hypothesize that the implants can prevent death from opioid overdose~     up to 6 months after commenced treatment.~   "
231899|NCT00520962|"~     The study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at~     high risk to develop alterations of glucose metabolism and definition of new pathogenic~     mechanisms of insulin resistance and atherosclerosis.~      The following classes of subjects at high risk will be considered:First degree relatives of~     patients with type 2 diabetes mellitus, patients with cardiovascular disease and stroke,~     patients with heart valve disease. age will be > 30 years, both gender.~   "
231887|NCT00521118|"~     This phase II trial studies how well a second curettage (removal of the abnormal cancer cells~     in the uterus using a method of surgically removing the lining of the uterus) works in~     treating patients with gestational trophoblastic tumors that did not go away after a first~     curettage (persistent) and has not yet spread to other places in the body (non-metastatic). A~     second curettage may be effective in treating persistent gestational trophoblastic tumors and~     may decrease the likelihood that patients will need chemotherapy in the near future.~   "
231888|NCT00521105|"~     The purpose of the study is to look at the effect of replacing the physician only visit by a~     transmission of information on the participant's current diabetes management and blood~     glucose monitoring results followed by a phone contact by the diabetes nurse educator. The~     study will also measure the effect on diabetes control (HbA1c), satisfaction with care,~     resource utilisation, and costs to the health care system and to the participant.~      We hypothesize that replacement of the physician-only visit by a virtual visit will not~     result in worsening of the medical outcomes and that it will result in a reduction in medical~     resources utilization and costs for families while increasing the satisfaction with care.~   "
231889|NCT00521092|"~     Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. This phase II trial is studying the~     side effects and how well sunitinib malate works in treating patients with Kaposi sarcoma.~   "
231890|NCT00521079|"~     This is a randomized multi-center study being done to measure the ability of a new medical~     device, Maestro System, to safely reduce body weight over five years in people who are~     considered obese.~   "
231891|NCT00521066|"~     The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in~     women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.~      (*TRADEMARK)~   "
231892|NCT00521053|"~     The primary objective of this study is to investigate the effectiveness of intralesional (IL)~     PV-10 for locoregional treatment of metastatic melanoma. This study will also include~     assessment of response in untreated bystander lesions following intralesional injection of~     PV-10 into targeted lesions. Additional objectives are to determine the safety profile of~     PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in~     the bloodstream following intralesional injection.~   "
231893|NCT00521040|"~     Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen~     Season in Subjects With SAR~   "
231894|NCT00521027|"~     The purpose of this study is to compare the VERSAJET™ device with conventional surgical~     procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of~     lower limb ulcers.~      It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the~     VERSAJET™ device than with conventional surgical procedures.~   "
231895|NCT00521014|"~     RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant helps stop~     the growth of cancer cells by stopping them from dividing or by killing them. An autologous~     stem cell transplant may be able to replace the blood-forming cells that were destroyed by~     chemotherapy. GM-CSF may increase the number of immune cells found in bone marrow or~     peripheral blood. Giving a monoclonal antibody, such as rituximab, after the transplant may~     find any remaining cancer cells and either kill them or deliver cancer-killing substances to~     them without harming normal cells. Giving GM-CSF together with rituximab after autologous~     stem cell transplant may be an effective treatment for follicular non-Hodgkin lymphoma.~      PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab after~     autologous stem cell transplant works in treating patients with relapsed or primary~     refractory follicular non-Hodgkin lymphoma.~   "
231896|NCT00521001|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by~     blocking some of the enzymes needed for cell growth. Giving everolimus together with~     temozolomide may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving everolimus together with~     temozolomide works in treating patients with stage IV melanoma that cannot be removed by~     surgery~   "
231897|NCT00520988|"~     We will improve hypertension control in Colorado by implementing a population-based~     intervention using interactive voice response (IVR) technology that will be delivered to~     patients in three healthcare systems across Colorado (Denver Health and Hospitals [DH], VA~     Colorado Healthcare System [VA], and Kaiser Permanente of Colorado [KPCO]). Together, these~     organizations serve over 1 million Coloradans. The IVR-based hypertension program will: 1)~     reach out to more patients using fewer resources than a traditional patient visit approach,~     2) implement evidence based guidelines for therapy, 3) facilitate patients' acquisition of~     medications by allowing them to order and receive medications at home, and 4) enhance~     medication adherence using tailored educational and motivational messages.~      HYPOTHESES:~        1. A sizable population of patients is at high risk for further cardiovascular morbidity~          and mortality, based on uncontrolled hypertension.~        2. An IVR-centered intervention among patients with diagnosed but uncontrolled hypertension~          is feasible.~        3. An IVR-centered intervention plus usual care for these patients improves BP control,~          compared to usual care alone.~   "
231898|NCT00520975|"~     This randomized phase III trial studies first-line chemotherapy and trastuzumab to compare~     how well they work when given with or without bevacizumab in treating patients with breast~     cancer that overexpresses human epidermal growth factor receptor 2 (HER-2/NEU) and has spread~     to other areas of the body. Drugs used in chemotherapy, such as paclitaxel and carboplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such~     as trastuzumab and bevacizumab, may interfere with the ability of tumor cells to grow and~     spread. Bevacizumab may also stop the growth of breast cancer by blocking the growth of new~     blood vessels necessary for tumor growth. It is not yet known whether giving first-line~     chemotherapy together with trastuzumab is more effective with or without bevacizumab in~     treating patients with metastatic breast cancer that overexpresses HER-2/NEU.~   "
231912|NCT00520780|"~     This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in~     patients with iron deficiency. Analyses will focus both on subjective and objective measures.~     Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.~   "
231900|NCT00520949|"~     Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold~     standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and~     either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an~     increasing evidence of H. pylori resistance to classical triple therapy. Another reason for~     this failure being low patient compliance with treatment. A regimen useful in one~     geographical area may not be effective or practical in another area. The aim of this study~     was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and~     safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed~     with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14~     days.~   "
231901|NCT00520936|"~     To determine the response rate of pemetrexed given every 21 days for the treatment of~     children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive~     neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma,~     medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.~   "
231902|NCT00520923|"~     The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023~     given orally to patients with schizophrenia twice daily for 4 weeks will have significantly~     greater effect than placebo.~   "
231903|NCT00520910|"~     With this study we will like to determine if taking a dose of the study medication, called~     Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse~     effects of UVA, a type of ultraviolet light. Ultraviolet light is a form of radiation which~     is not visible to the human eye. The sun produces different types of ultraviolet radiation,~     and UVA is one of them. More than 95% of the solar UV energy that reaches our skin is from~     the UVA type. UVA penetrates cloud cover and glass windows.~      PL extract comes from a tropical fern plant grown in Central and South America, and it is a~     dietary supplement available in the US. No side effects have been reported with Polypodium~     leucotomos extract since becoming commercially available in 1982. Also, PL extract was~     approved for oral use by the Institutional Review Board of The Massachusetts General~     Hospital, Boston, for studies by Harvard Medical School faculty in human volunteers that were~     carried out for a period of two years, using artificial light and sunlight as ultraviolet~     sources.~      This is an investigator-blinded study, which means that the doctor evaluating you will not~     know if you are receiving the study medication or not. Another doctor will be supplying you~     with the medication and discussing any problems that you may have with the medication.~      You will be assigned to one of the two treatment groups. The group will be assigned by chance~     and you will have a one in two chances of receiving either the study medication or no~     treatment.~   "
231904|NCT00520897|"~     The eradication of HIV by antiretroviral therapy has thus far been elusive. It has been~     consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in~     the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma~     viremia has been successfully suppressed for prolonged periods of time; this pool has emerged~     as the major obstacle in achieving the eradication of HIV. We believe that MK-0518 can~     further the decay and suppression of HIV-1 in patients who have been virologically suppressed~     for a prolonged period of time on effective cART (≥ 4 years).~   "
231905|NCT00520884|"~     The purpose of this research study is to see if giving women a hormone called ghrelin will~     increase levels of growth hormone in the blood and increase appetite. Ghrelin is a naturally~     occurring hormone that is produced mostly by the stomach and causes secretion of another~     hormone called growth hormone. It also increases short-term appetite and may lower the amount~     of inflammation in the body.~      Some people lose their appetite as they age and have unintentional weight loss. This may be~     caused by a break in the communication between the stomach and the brain. We are particularly~     interested in seeing if there is a difference in the effects of ghrelin in older women who~     have lost weight recently without wanting to and those who have not.~   "
231906|NCT00520871|"~     We will study the effect of supplementation of 1 L blueberry juice to participants with at~     least one elevated cardiovasculat risk factor.~   "
231907|NCT00520858|"~     The prevalence of abdominal obesity in the elderly is increasing at alarming rates and thus,~     requires immediate attention. By comparison to younger adults, obesity reduction in the~     elderly presents a unique challenge and requires an innovative approach. We propose a novel~     approach to investigate the effects of different exercise types as independent treatment~     strategies for the reduction of obesity and related health risk factors in older men and~     women. We propose that exercise without caloric restriction will be associated with modest~     weight loss (3-5%), that in turn will be associated with significant reduction in abdominal~     obesity, insulin resistance, and a corresponding increase in skeletal muscle mass and~     function. We will determine the separate effects of resistance and aerobic exercise on these~     primary outcome variables, and, whether a treatment strategy that combines the two is~     optimal.~   "
231908|NCT00520845|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes need~     for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving celecoxib together with docetaxel or pemetrexed may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well celecoxib given together with docetaxel or~     pemetrexed works in treating patients with advanced or recurrent non-small cell lung cancer.~   "
231909|NCT00520832|"~     Participants identified as having primary insomnia will be randomly assigned to groups~     receiving microcurrent stimulation or sham in a double-blind randomized controlled trial. The~     microcurrent device used is FDA approved for the treatment of insomnia.~      The hypothesis is that the experimental group will have significantly improved scores on~     three sleep surveys after treatment while the sham group will not.~   "
231910|NCT00520819|"~     The primary objective of this study is to test whether increasing the total intake of~     antioxidants to middle-aged smoking men increases the antioxidant defence, reduces oxidative~     damage, and improves biomarkers for oxidative stress.~      The secondary objectives is to test whether this strategy improves other cardiovascular risk~     markers including platelet function, lipid levels, inflammation, and markers of endothelial~     damage.~   "
231911|NCT00520806|"~     Different doses of relaxin will be compared to placebo to determine efficacy and safety for~     the treatment of patients hospitalized with acute heart failure~   "
231913|NCT00520767|"~     RATIONALE: Giving bortezomib together with melphalan and dexamethasone may be an effective~     treatment for primary amyloidosis and light chain deposition disease.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with melphalan~     and dexamethasone works in treating patients with primary amyloidosis or light chain~     deposition disease.~   "
231914|NCT00520754|"~     Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other~     Allergic Symptoms in Children~   "
231915|NCT00520741|"~     The objective of this historical-controlled trial is to demonstrate the efficacy and safety~     of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are~     withdrawn from 1 to 2 marketed antiepileptic drugs.~   "
231916|NCT00520728|"~     The purpose of this study is to test the efficacy of a new Occupational Time Use Intervention~     designed to increase activity participation and improve meaning in the lives of people with~     serious mental illness living in the community.~   "
231917|NCT00520715|"~     Emergence of bacterial resistance to antibiotics, which is a major public health issue,~     appears to involve predominantly commensal flora. No data exists concerning risk factors for~     the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. We~     will conduct a prospective open study including all unselected patients hospitalised in~     medical wards of one hospital. Nasal, pharyngeal and rectal swabs will be performed upon~     admission as well as a review of potential risk factors, after patient's information and~     acceptance. Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli)~     will be performed on all specimens, and a case control study will compare risk factors from~     the resistant and non-resistant groups, for each pathogen. A thousand patients should be~     included in a year's time. This work could help understand risk factors involved in the~     carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive~     infections and inter-patient transmission of resistance. Limiting bacterial resistance and~     transmission is a goal that can be successfully undertaken only if resistance mechanisms, but~     also risk factors of acquiring resistant bacteria are better understood.~   "
231918|NCT00520702|"~     Primary Objective:~        -  Developing Common Toxicity Criteria (CTC) 3.0 grade > 3 treatment related pneumonitis~          (TRP) or~        -  Developing local-regional recurrence among patients treated with 3D conformal radiation~          therapy (CRT) (Arm 1) or intensity modulated radiation therapy (IMRT) (Arm 2).~      Secondary Objectives:~        -  To assess and compare the time to develop CTC 3.0 grade > 3 radiation esophagitis in~          patients with non-small cell lung cancer (NSCLC) treated in arm 1 and arm 2.~        -  To investigate the association of inflammatory cytokines with the time to the~          development of radiation pneumonitis and outcomes to concurrent chemoradiation between~          arm 1 and arm 2.~        -  To investigate the association of relevant pharmacogenetics, biomarkers, and gene~          polymorphisms with the time to the development of radiation pneumonitis and treatment~          outcomes to concurrent chemoradiation between arm 1 and arm 2.~        -  To evaluate image guided adaptive radiation therapy (IGART) using weekly computed~          tomography (CT) on rail or cone beam CT in the assessment of tumor response and impact~          on treatment planning and delivery.~        -  To compare overall survival, progression-free survival, median survival time, in arm 1~          and arm 2.~        -  To evaluate the role of functional image of fluorodeoxyglucose-positron emission~          tomography (FDG-PET) in assessing and predicting the time to the development of TRP and~          tumor response.~        -  To measure and compare symptom burden over time of the treatment using MD Anderson~          Symptom Inventory (MDASI)-Lung in the 2 arms.~        -  To determine the impact of comorbid conditions on survival.~   "
231919|NCT00520689|"~     The purpose of this study is to verify the compatibility of a silicone hydrogel lens when~     used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®,~     Solo-Care Aqua™ and MeniCareTM Soft).~   "
231920|NCT00520676|"~     The purpose of this study is to compare the combination of pemetrexed and carboplatin with~     the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4~     toxicity in previously untreated patients with locally advanced or metastatic non-small cell~     lung cancer (NSCLC).~   "
231921|NCT00520663|"~     The purpose of this study is to define the absorption, breakdown and excretion of a single~     dose of radiolabelled SB-649868 and its breakdown products by measuring their concentration~     in blood, urine and faeces over a 7-10 day period. Radiolabelled means that the test drug~     has a radioactive component to help us track the drug. The safety and tolerability of the~     test drug will also be assessed.~   "
231922|NCT00520650|"~     This is a post-market surveillance, and the treatment to patients will be depended upon the~     decision based on physician's clinical judgment. The health profiles during the switching~     period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will~     be recorded and evaluated.~   "
231923|NCT00520637|"~     The goal of this clinical research study is to find the highest tolerable dose of EZN-2208~     that can be given to patients with advanced cancer or lymphoma. The safety of the study drug~     and its effect on the disease will also be studied.~      Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the~     amount of a drug in the body at different time points.~   "
231924|NCT00520624|"~     Treatment of exercise-induced laryngomalacia (an obstruction of larynx during physical~     activity) in elite athletes using two different treatments. The study is randomized with~     control groups.~   "
231939|NCT00520429|"~     The primary objective of this research is to pilot test a brief mental heath treatment~     specifically tailored to meet the needs of chronically ill patients with anxiety and/or~     depression. Using an open-trial format, the proposed study will examine the feasibility of a~     brief psychosocial intervention. Primary outcomes will assess intervention effects on patient~     and clinician rated symptoms of anxiety and depression. If proven feasible and effective~     among this group of participants, the intervention (due to its brief format and focus on~     medically ill patient needs) will possess unique characteristics that will increase the~     ability of medical care settings to implement mental health treatments, and will provide~     valuable pilot data for the development of a larger research project to determine the~     efficacy of this intervention among a larger group of chronically ill patients relative to~     usual care.~   "
232174|NCT00517361|"~     The purpose of this study is to determine the progression free survival (PFS) of metastatic~     ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab~     (Avastin®) therapy.~   "
231925|NCT00520611|"~     Obesity is a major cause of premature aging and the second leading cause of preventable~     mortality in the United States, accounting for approximately 110,000 deaths per year.~     Financial incentives have been effective in modifying a number of health behaviors but they~     have rarely been applied to weight loss, and to the best of our knowledge never to weight~     loss by low-SES obese veterans.~      We propose testing two different approaches to using financial incentives to encourage weight~     loss. In the first, we build on previous work showing the effectiveness of 'deposit~     contracts', in which subjects are given the opportunity to put their own money at risk if~     they do not lose weight. In this incentive condition, subjects receive a direct payment~     conditional on daily weight loss, and an optional additional payment based on their own~     contributions to the deposit contract. We will match their contribution 1:1 to make the~     option of depositing their own money attractive to this predominantly low SES population. In~     the second approach we build on our own prior work using lotteries to promote drug adherence.~     In this incentive condition, participants are entered into a daily lottery, and receive any~     payoffs they earn from the lottery only if they stay on track with their weight-loss goal.~     Given their popularity in the general population, lotteries hold the promise of providing a~     cost-effective means of motivating weight loss and making efforts to lose weight more salient~     to obese patients.~   "
231926|NCT00520598|"~     The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison~     to GARDASIL (TM)~   "
231927|NCT00520585|"~     The aim of this study is to evaluate influence of atorvastin on the repolarisation phase of~     cardiomyocytes. If there is any, it could be a part of positive non-lipid effect of statins~     in therapy of ischaemic heart disease.~      Study hypothesis: atorvastin will decrease heterogeneity of repolarisation of cardiomyocytes~     in comparison with placebo~   "
231928|NCT00520572|"~     The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid~     arthritis with regard to signs and symptoms and to determine what dose is favourable over a~     6-month treatment period. Patients will receive background treatment with either Methotrexate~     or Sulphasalazine~   "
231929|NCT00520559|"~     The purpose of this study is to provide accurate prognostic data linking cardiac~     complications to myocardial T2* values (A measure of iron levels in the heart using MRI)in~     patients predisposed to heart iron overload.~   "
231930|NCT00520546|"~     To investigate the sensitivity of the [18F]fluoroethylcholine (FEC)~     Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) method in tumour detection~     and location (side assignment, encapsulation, invasion of the seminal vesicle) and detection~     of affected lymph nodes, and to compare these with presently used detection procedures~     (needle biopsy, digital rectal examination, transrectal ultrasound, and pre-therapeutic~     assessment), with a view to finding out whether the [18F]fluoroethylcholine PET/MRI method is~     comparable to, or superior to, the established method. Postoperative histology served as the~     standard of reference.~   "
231931|NCT00520533|"~     This clinical trial explores the safety, efficacy, and effects on functional imaging of the~     combination of cG250 monoclonal antibody administered intravenously weekly in combination~     with daily oral sunitinib, in patients with advanced renal cell carcinoma.~   "
231932|NCT00520520|"~     Mild therapeutic hypothermia is indicated in patients surviving out-of-hospital cardiac~     arrest due to ventricular fibrillation. Potential immunologic responses are unknown.~   "
231933|NCT00520507|"~     OBJECTIVES:~      Primary Objective:~      To assess the objective (polysomnographic) changes in sleep quality before and after~     introduction of olanzapine in treatment of patients with depression.~      Secondary Objectives:~      To assess the subjective changes in sleep quality parameters before and at different stages~     after introduction of olanzapine in treatment, longitudinally, and to correlate these changes~     with measures of illness severity and changes in cognition.~      STUDY DESIGN:~      Prospective, double blind, randomized polysomnographic (PSG) study of patients before and~     after treatment with olanzapine.~      PSG recordings will be done three times throughout the study: before starting olanzapine~     augmentation (baseline), at day 3 to 5 (acute) and day 28 to 31 (chronic). PSG will be~     completed at patients' homes with a portable PSG. Psychiatric scales, subjective sleep~     quality scales, and cognition measurements will be completed at each visit.~   "
231934|NCT00520494|"~     The objective of this study is to assess the efficacy and safety of Vivaglobin in previously~     untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation~     period. The purpose is to investigate whether PUPs will respond to subcutaneous~     immunoglobulin (SCIG) treatment with adequate trough levels without first receiving~     immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg~     body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of~     500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG~     therapy.~   "
231935|NCT00520481|"~     This single arm, multicenter, open-label, phase II study will enroll chemotherapy-naive~     patients with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1~     D2). Treatment will continue until there evidence of disease progression, intolerable~     toxicity, or other withdrawal criteria are met. Non-surgically castrated patients must~     continue the use of LHRH agonists during protocol treatment.~   "
231936|NCT00520468|"~     Objectives:~      Primary: To evaluate the response rate of total cytokine-immunotherapy for low-risk~     myelodysplastic syndromes (MDS).~      Secondary: To evaluate response duration, survival and side effects of the treatment.~   "
231937|NCT00520455|"~     The purpose of this trial is to determine whether providing non-contracepting women with~     gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and~     condoms decreases their risk of becoming pregnant.~   "
231938|NCT00520442|"~     A clinical trial comparing ibuprofen and acetaminophen with codeine for children after~     discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more~     effective analgesia compared to acetaminophen with codeine in children with uncomplicated~     forearm fractures.~   "
232057|NCT00518895|"~     This study is being performed to prospectively determine whether dacarbazine plus Genasense~     is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with~     advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit~     of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial~     of dacarbazine plus Genasense.~   "
231940|NCT00520416|"~     Endovascular repair of infrarenal abdominal aortic aneurysms (AAA) requires a contrast agent~     to identify the vascular anatomy and placement of the stent graft. Iodine contrast has~     traditionally been used, but has the potential to harm the kidneys. Another contrast agent is~     carbon dioxide gas. It has been proven safe to use, but the quality of the images it creates~     needs to be compared to iodine contrast. Patients in this study undergo the endovascular AAA~     repair as they normally, with the iodine contrast. At the end of surgery carbon dioxide gas~     contrast is given as an extra step. The images will be later evaluated.~   "
231941|NCT00520403|"~     This single arm study will assess the efficacy and safety of Avastin in combination with~     interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal~     cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3~     times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3~     weeks. The anticipated time on study treatment is until tumor progression, and the target~     sample size is 100-500 individuals.~   "
231942|NCT00520390|"~     The goal of this clinical research study is to find the highest tolerable dose of EZN-2208~     that can be given to patients with advanced cancer or lymphoma. The safety of the study drug~     and its effect on the disease will also be studied.~      Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the~     amount of a drug in the body at different time points.~   "
231943|NCT00520377|"~     The primary objective is the area of newly formed bone (%) as assessed by histomorphometry~     with either MD05 or beta-TCP.~   "
231944|NCT00520364|"~     Objective: Chemotherapy regimens containing alkylating agents result in primordial follicle~     death and premature ovarian failure. Depending on the age and the type/dose of chemotherapy,~     some women may continue to menstruate. Our aim was to ascertain the impact of chemotherapy on~     ovarian reserve in patients who previously received chemotherapy by response to controlled~     ovarian hyper stimulation (COH) and anti-mullerian hormone (AMH) levels. Design: Prospective~     study with retrospective controls Materials and Methods: 45 cancer patients underwent~     controlled ovarian stimulation for IVF before (30 patients, 30 IVF cycles) or after (15~     patients, 30 IVF cycles) chemotherapy. Patients with basal serum FSH >13mIU/mL or E2>70pg/ml~     were excluded. AMH was measured on previously stored serum samples from the day of initiation~     of the ovarian stimulation. Results: Mean ages and baseline FSH levels of pre- and~     postchemotherapy IVF patients were similar (36.8±0.91 vs. 36.3±1). The mean interval from~     completion of chemotherapy to IVF was 8.03±1.32 years (range 1-23). Of the 30 IVF cycles in~     post-chemotherapy patients, 22 received alkylating agents and 8 did not.~      There were no significant differences between the study and control cycles regarding day-2~     estradiol (E2), length of stimulation, total gonadotropin dose, and E2 on hCG day (table 2).~     Cycle cancellation rate was 20% and 26.67% for pre and post-chemotherapy patients,~     respectively. The number of oocytes retrieved and fertilized were significantly higher in~     pre-chemotherapy group (p<0.0001). Two clinical pregnancies were achieved in the~     postchemotherapy group, one ending in spontaneous abortion and the other in the delivery of a~     healthy baby (6.67% clinical pregnancy rate and 3.33% delivery rate per attempted cycle). All~     fertilized oocytes in the control group were cryopreserved at 2-pronuclei stage.~      Baseline AMH levels were significantly lower in post chemotherapy IVF patients compared to~     those who underwent IVF prior to chemotherapy (0.270 ±0.077 vs. 0.84±0.27 ng/ml, p=0.03). In~     the pre-chemotherapy group there was a positive correlation between the AMH levels and the~     number of oocytes retrieved (r=0.663, p=0.004 ). This correlation was not detected in the~     post chemotherapy group (r=0.205).~   "
231945|NCT00520351|"~     The purpose of the study is to evaluate and compare, on a daily wear basis, the performance~     of two contact lens care solutions when used with silicone hydrogel soft contact lenses with~     regards to comfort and dryness symptoms.~   "
231946|NCT00520338|"~     The purpose of this study is to determine whether celecoxib is effective in the treatment~     postoperative pain after thyroidectomy.~      The research hypothesis:~      There is a difference in postoperative morphine consumption in the first 24 hours after~     thyroidectomy between patients who received celecoxib or placebo.~   "
231947|NCT00520325|"~     The goal of this clinical research study is to find the dose of EZN-2232 that can be given to~     MBL deficient pediatric cancer patients undergoing chemotherapy. The pharmacokinetics,~     pharmacodynamics, and safety of the study drug will also be studied.~   "
231948|NCT00520312|"~     Peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque,~     accumulates in the peripheral arteries. People with PAD often experience leg pain while~     walking due to reduced blood flow to the legs. This study will use magnetic resonance imaging~     (MRI) techniques to examine how specific features of plaque build-up in the leg arteries~     affect walking ability, leg strength, and balance in people with PAD.~   "
231949|NCT00520299|"~     This was a phase 1/2, open-label, dose-escalation study of arginine deiminase linked via~     succinimidyl succinate to polyethylene glycol of 20,000 molecular weight (ADI-PEG 20) in~     subjects with advanced melanoma. ADI-PEG 20 was administered intramuscularly (IM) at~     escalating doses weekly for 9 weeks (cycle 1) or 8 weeks (subsequent cycles). The primary~     objectives were to the establish the safety, tolerability, and clinical efficacy of ADI-PEG~     20. Secondary objectives included evaluation of the metabolic activity by~     [18F]-fluorodeoxyglucose positron emission tomography (FDG PET), pharmacodynamics,~     correlation of immunogenicity with clinical response, and correlation of argininosuccinate~     synthetase (ASS) tumor expression with clinical response.~   "
231950|NCT00520286|"~     The purpose of this study will be to examine the safety and efficacy of modafinil in~     increasing number of methamphetamine non-use weeks in subjects with methamphetamine~     dependence.~   "
231951|NCT00520273|"~     This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous~     detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor~     samples in 96-unit pools.~   "
231952|NCT00520260|"~     To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine~     ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of~     treatment for chronic dry eye disease~   "
231953|NCT00520247|"~     Combinded therapy with folic acid and enalapril may significantly decrease plasma total~     homocysteine level and had beneficial effect on blood pressure reduction and glycometabolism.~   "
231954|NCT00520234|"~     Adults admitted to intensive care units are at risk for a variety of complications.~     Infections due to the fungus called candida are of particular concern. The study will test~     the possibility that caspofungin, a new therapy for fungal infections, can successfully~     reduce the rate of candida infections in subjects at risk. It will also test if caspofungin~     is useful in treating subjects for this disease when diagnosed using a new blood test that is~     performed twice weekly, permitting earlier diagnosis than current practice standards.~   "
231955|NCT00520221|"~     The optimal initial management of primary spontaneous pneumothorax (PSP) remains~     controversial. This study was conducted to evaluate the safety and efficacy of additional~     minocycline pleurodesis after successful aspiration of the first episode of PSP.~   "
231956|NCT00520208|"~     This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, and~     pharmacokinetics of tamibarotene in adult patients with relapsed or refractory acute~     promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and~     arsenic trioxide (ATO). Patients must have received and failed therapy with ATRA and ATO.~     Treatment may have been administered either as combination therapy or sequentially as single~     agents. Patients who are intolerant to either drug are eligible for this study.~   "
231957|NCT00520195|"~     This is an intervention study which evaluates the cardiovascular primary preventive effects~     of using stairs instead of elevators at the worksite during a 12-weeks period. We hypothesize~     that stair-climbing during working hours can meet the daily amount of physical activity~     recommended by current public health guidelines.~   "
231958|NCT00520182|"~     Obese patients with type 2 diabetes often fail to loose weight and thus do not succeed in~     improving their sugar and lipid profiles and remain at high risk for diabetes complications~      The study enrolled 259 obese diabetic patients attending HMO clinics in central Israel. Over~     a 6 month period the participants met with a dietitian every fortnight and attended group~     lectures every 2 months.~      The objective of this intervention was to compare three dietary intervention along with close~     monitoring of the patients by dietitians, regarding blood lipid and sugar balance as well as~     weight loss. The three diets are the American Diabetes Association (ADA) diet from 2003; a~     diet containing low glycemic index carbohydrate otherwise similar to the ADA diet; and a low~     glycemic index diet with more fat than the other 2 diets with high proportion of~     mono-unsaturated fatty acids.~      Patients were individually randomized to receive one of the three diets. Among the measures~     obtained every 3 months for the first year and every 6 months thereafter are weight, fasting~     insulin and glucose, glycosylated hemoglobin, blood and urine chemistry profiles and lipid~     profile.~   "
231959|NCT00520169|"~     This is an open label, single-center study to determine the absolute bioavailability and~     nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.~   "
231960|NCT00520156|"~     There is a well-documented but poorly understood relationship between headache disorders~     (e.g. migraine, cluster headaches, awakening headaches, etc.) and sleep disorders. One~     hypothesis includes an underlying disorder known as obstructive sleep apnea (OSA) with low~     overnight oxygen saturations and possibly elevated carbon dioxide levels which result in~     awakening headache. Bruxism, or grinding of the teeth, has also been anecdotally associated~     with headache. The converse of these arguments is that the patient may have a primary~     headache disorder, for example migraine, leading to disordered sleep patterns or insomnia.~     The true relationship between the two, as alluded above, is unknown. The actual prevalence of~     the two disorders occurring simultaneously is not known.~      There have been several small, retrospective studies which have attempted to evaluate this~     relationship. One of these studies evaluated those patients diagnosed with OSA who were given~     the standard of care therapy - continuous positive airway pressure (CPAP) - and found that~     headaches among these patients were improved after using CPAP. Again, this was a small,~     retrospective study.~      We propose a study whereby patients who are referred for polysomnography (PSG, or sleep~     study) are consented, then surveyed on the presence or absence of headache. A brief~     questionnaire is followed up with a more detailed questionnaire to characterize whether this~     headache that the patient has is truly a headache disorder. Following the survey and PSG, the~     patient's sleep study parameters are evaluated to see whether there are certain correlations~     between what has been recorded and the particular headache disorder present.~      Lastly, if the patient was diagnosed with OSA and fitted with a CPAP device, the patient will~     be queried several weeks later to evaluate whether there was improvement or cessation of the~     headache disorder.~   "
231961|NCT00520143|"~     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The objective of this expanded access study is to provide patients with~     Pompe disease in the United States (US), access to alglucosidase alfa produced from a scaled~     up manufacturing process for a limited time until production at this scale is approved for~     commercial use by the Food and Drug Administration.~   "
231962|NCT00520130|"~     Background:~      Major problems with stem cell transplantation (SCT) for cancer treatment are a lack of~     suitable donors for patients without a human leukocyte-antigen (HLA) tissue-matched sibling~     and graft-versus-host disease (GVHD), a serious side effects of immune-suppressing~     chemotherapy that is given to bring the cancer under control before SCT. In GVHD, the~     patients immune system attacks the transplanted donor cells.~      This study will try to improve the results of SCT from unrelated HLA-matched donors using~     targeted immune-depleting chemotherapy to bring the cancer under control before~     transplantation and to lower the chance of graft rejection, followed by reduced-intensity~     transplant chemotherapy to make the procedure less toxic.~      Objectives:~      To evaluate the safety and effectiveness of targeted immune-depleting chemotherapy followed~     by reduced-intensity transplant chemotherapy in patients with advanced cancers of the blood~     and immune system.~      To evaluate the safety and effectiveness of two different drug combinations to prevent GVHD.~     Both regimens have been successful in preventing GVHD, but they work by different mechanisms~     and affect the rebuilding of the immune system after the transplant.~      Eligibility:~      People 18 to 74 years of age with advanced or high-risk cancers of the blood and immune~     system who do not have a suitable HLA-matched sibling.~      Design:~      All patients receive chemotherapy before transplant to treat the cancer and suppress immune~     function.~      All patients receive a conditioning regimen of cyclophosphamide for 4 days and fludarabine~     for 4 days before SCT to prepare for the transplant.~      Patients are randomly assigned to one of two combination drug treatments to prevent GHVD as~     follows:~        -  Group 1: Tacrolimus starting 3 days before SCT and continuing for 6 months, plus~          methotrexate on days 1, 3, 6, and 11 post-SCT, plus sirolimus starting 3 days before the~          SCT and continues for 6 months following SCT.~        -  Group 2: Alemtuzumab for 4 days starting 8 days before SCT, plus cyclosporine starting 1~          day before SCT and continuing for 6 months.~      Patients receive the donors stem cells and immune cells 2 days after completing the~     conditioning regimen.~      Patients are followed at the clinic regularly for the first 6 months after SCT, and then less~     often for at least 5 years. Some visits may include bone marrow aspirates and biopsies, blood~     draws, and other tests to monitor disease status.~      A skin biopsy, oral mucosa biopsy, and saliva collection are done to study chronic GVHD.~   "
231963|NCT00520117|"~     The primary purpose of this study is to assess the psychosocial burden in women who have~     experienced an abnormal pap results after screening interventions.~   "
231964|NCT00520104|"~     This is an open label, single-center study to determine whether certain nasal medication~     interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients~     with allergic rhinitis.~   "
231965|NCT00520091|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     chemotherapy and radiation therapy together with celecoxib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan and cisplatin together~     with radiation therapy with or without celecoxib works in treating patients with stage II,~     stage III, or stage IV esophageal cancer.~   "
232085|NCT00518531|"~     The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg~     denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW)~     treatment at the end of treatment period 1 (12 months).~   "
231966|NCT00520078|"~     Acrochordon, or soft fibroma, is a common benign skin tumor which is generally regarded as a~     sign of cutaneous aging or as a reaction to friction since it occurs in the intertriginous~     areas. Recent studies have shown the presence of human papillomaviruses, especially the~     mucosal types, on some of the intertriginous lesions. This study is to analyze the different~     clinical presentations of acrochordon and correlate them with pathologic and molecular human~     papillomavirus findings. Further goal is to improve the ability to differentiate acrochordon~     and its possible prevention and treatment. Also, it may have an implication on the~     transmission and prevention of cervical carcinoma.~   "
231967|NCT00520065|"~     Part A: To compare the glucose and insulin responses of a standard tube feeding product to~     that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.~      Part B: To compare the glucose response of a standard tube feeding product to that of a~     diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a~     sole source of nutrition.~   "
231968|NCT00520052|"~     The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over~     one year, improves the bone mineral density in osteoporotic patients undergoing androgen~     deprivation therapy for prostate cancer~   "
231969|NCT00520039|"~     The purpose of this study is to determine if the application of osteopathic manipulative~     medicine speeds the rate of resolution of middle ear effusion (fluid) in children following~     an episode of acute otitis media.~   "
231970|NCT00520026|"~     The purpose of this study is to examine the proposed suicide preventive effects of lithium in~     a randomized controlled trial within a group of individuals with depressive disorders. The~     hypothesis being tested is that lithium treatment will significantly reduce the risk for~     another suicide attempt.~   "
231971|NCT00520013|"~     The purpose of this research study is to evaluate how patients with newly diagnosed advanced~     ovarian, fallopian tube, primary peritoneal cancer and papillary serous or clear cell~     mullerian tumors respond to consolidation therapy with Avastin and erlotinib or Avastin alone~     over 1 year. These drugs have been used in the treatment of other types of cancers and~     information from those studies suggests that these agents may help to treat the cancers~     studied here.~   "
231972|NCT00520000|"~     RATIONALE: Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle~     formulation and carboplatin work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized~     nanoparticle formulation together with carboplatin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects, the best way to give, and the best~     dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with~     carboplatin in treating patients with advanced or metastatic solid tumors.~   "
231973|NCT00519987|"~     This is an open label, single-center study of the pharmacokinetic and safety profile of~     repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.~   "
231974|NCT00519974|"~     RATIONALE: Learning about the reasons for choosing to have, or not to have, breast~     reconstruction after mastectomy for breast cancer may help doctors understand why black or~     Latina women may or may not undergo breast reconstruction.~      PURPOSE: This clinical trial is studying factors affecting decisions about breast~     reconstruction after mastectomy in black and Latina women.~   "
231975|NCT00519961|"~     The purpose of this study is to validate the screening potential of NT-proBNP for the~     identification of patients scheduled for vascular surgery who would benefit from additional~     pre-operative cardiac testing. All patients will have NT-proBNP concentrations measured~     pre-operatively. For low-intermediate risk patients only those with abnormal values will~     receive further cardiac testing; all high risk patients will be referred for additional~     testing.~   "
231976|NCT00519948|"~     To compare patient comfort and overall lens cleanliness with consecutive use of two~     multipurpose lens solutions.~   "
231977|NCT00519935|"~     The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an~     intensive home-based family psychotherapy intervention, to a group of urban adolescents with~     poorly controlled Type 1 diabetes and their families.~   "
231978|NCT00519922|"~     This pilot study will test the testing and exercise training protocols for a larger study~     that is in the desing phase and may be modified based on the findings of this study. Two~     exercise groups will be compared; one is a stadard treatment group using leg strength~     exercises that are commonly employed in therapy clinics. The other group will do balance and~     agility type exercises, but no specific strength exercises. These KBA exercises are~     increasingly common in therapy clinics, but very little research has been conducted on their~     effectiveness in treating knee osteoarthritis symptoms. Participants in this study will~     complete three short paper and pencil tests at the beginning and end of the study (8 weeks of~     exercise) as well as a leg strength test, a leg endurance test, two short walking tests, and~     a stair climb/descend test. One of the paper and pencil tests will be taken every two weeks~     in an effort to see how quickly changes to symptoms might occur. The exercise programs will~     be conducted 3 afternoons per week (Mon-Wed-Fri) and will be lead by an ACSM certified~     instructor.~   "
231979|NCT00519909|"~     The overall purpose of this study is to examine the effect of calcium on fecal fat and energy~     excretion.~   "
231980|NCT00519896|"~     This phase II trial studies how well giving sunitinib malate works in treating patients with~     iodine-refractory recurrent or metastatic thyroid cancer. Sunitinib malate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking~     blood flow to the tumor~   "
231981|NCT00519883|"~     This is a randomized, phase III trial of a 12 week exercise program, followed by a 36 week~     voluntary, self-directed exercise program (total 48 weeks) compared to standard supportive~     care. The purpose of the trial is to determine whether the exercise program is better than~     standard supportive care to decrease the muscle and joint aches (musculoskeletal symptoms)~     that result from aromatase inhibitors.~      Hypothesis An exercise program that includes stretching, strengthening and aerobic components~     may improve physical quality of life among women with musculoskeletal symptoms who are taking~     aromatase inhibitors.~   "
232175|NCT00517348|"~     To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMA-026~     administered subcutaneously (SC) or intravenously (IV) in healthy adults.~   "
231982|NCT00519870|"~     In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs)~     and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the~     inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration~     of endothelial dysfunction. These beneficial effects, render those agents appropriate for use~     in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs~     in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was compared~     with those of the calcium channel blocker, nifedipine in the treatment of pulmonary~     hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise~     test, and endothelin-1 levels.Losartan is as effective as nifedipine for reducing Doppler~     echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET. However~     the short-term use of losartan or nifedipine had no statistically significant effect on~     endothelin-1 levels in patients with PHT.~   "
231983|NCT00519857|"~     Tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected~     to be effective in preventing fractures in osteoporotic women. Tibolone could be more~     acceptable for long-term use, in particular since it does not induce a regular withdrawal~     bleed.~      The objective of this trial is to compare placebo and tibolone, a steroid with tissue~     specific activity, in the prevention of spinal fractures in women meeting the WHO criteria~     for osteoporosis or who have asymptomatic vertebral fractures.~   "
231984|NCT00519844|"~     This trial is conducted in Europe. The aim of this trial is to assess satisfaction with~     growth hormone treatment in children of both sexes born small for gestational age and who are~     receiving growth hormone treatment.~   "
231985|NCT00519831|"~     RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find~     tumor cells and help kill them or carry tumor-killing substances to them. Others interfere~     with the ability of tumor cells to grow and spread. Giving vinflunine together with cetuximab~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving vinflunine together with cetuximab~     works as second-line therapy in treating patients with stage IIIB or stage IV non-small cell~     lung cancer.~   "
231986|NCT00519818|"~     This study will test a new, extended release form of hydrocortisone called Chronocort in~     patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of the~     adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the sex~     hormone androgen. Medicines called glucocorticoids (hydrocortisone, dexamethasone and~     prednisone) are currently used to treat CAH, but finding the best dose of these drugs that~     effectively lowers androgens without causing undesirable side effects, such as weight gain~     and slow growth rate in children, is often difficult to achieve.~      Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this~     study. Children 16 years of age and older are eligible with confirmation by bone age that~     they are no longer growing.~      Participants undergo the following tests and procedures during two inpatient visits one month~     apart at the NIH Clinical Center:~        -  Medical history and physical examination.~        -  Medications: Following 7 days of Cortef (standard drug treatment for CAH), patients~          begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day~          for 1 month.~        -  Blood tests: A catheter (plastic tube) is inserted in a vein and left in place for~          frequent blood draws in order to avoid repeated needlesticks. Blood is drawn for~          chemistries, blood count, pregnancy test in women, and for serial tests (up to 26~          samples in a 24-hour period) to measure hormone levels.~        -  24-hour urine test.~        -  Height and weight measurements.~      Between the two hospitalizations, patients are contacted by NIH weekly to check for possible~     side effects from Chronocort. Two weeks after the first visit, patients also will have blood~     drawn by their regular doctor or a local clinic. A few days before the second~     hospitalization, patients undergo a 20-minute telephone questionnaire about energy level and~     well being.~      About 30 days after discharge from the second hospitalization, patients are followed up with~     a telephone call to see how they are doing.~   "
231987|NCT00519805|"~     RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in~     patients with lung cancer. It is not yet known whether dalteparin is effective in preventing~     blood clots in patients with lung cancer.~      PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing~     blood clots in patients with lung cancer.~   "
231988|NCT00519792|"~     Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon~     subcutaneously at a constant rate for 90 days.~      This study is being performed to evaluate the safety and antiviral effects of omega~     interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects~     with chronic Hepatitis C genotype 1.~   "
231989|NCT00519779|"~     This study is designed to examine the effects of fish oil on immune function and mood in~     medical students.~   "
231990|NCT00519766|"~     Smoking during pregnancy is the single most preventable cause of illness and death among~     mothers and infants. Because of the stigma associated with tobacco use during pregnancy,~     pregnant women are less likely to disclose their smoking status to doctors or study~     researchers. This study will evaluate the use of a new biomarker of nicotine metabolism to~     estimate tobacco use in a group of pregnant women who participated in the New England Smoking~     Cessation and Reduction in Pregnancy Trial (SCRIPT).~   "
231991|NCT00519753|"~     The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled~     glaucoma patients to DuoTrav from other mono or adjunctive therapies.~   "
231992|NCT00519740|"~     The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in~     patients with allergy on grass pollen after specific bronchial provocation. Therefore, the~     investigators will record the patients' nutrition habits and measure the blood level of long~     chained polyunsaturated fatty-acids.~   "
231993|NCT00519727|"~     The primary purpose of this trial is to assess the safety of ISIS 325568 when given at~     increasing single doses and to assess the safety of the same doses when given multiple times.~   "
232011|NCT00519493|"~     This investigator initiated study, single-blinded, parallel, randomized study will be~     conducted in subjects with 2 or more keloids similar in size and duration on a similar area~     of the body. The response of the closure techniques will be evaluated by clinical and~     instrumental assessments. Each qualified subject will be assessed and the keloids will be~     randomly assigned to the Clozex or suture closure. One keloid will be surgically excised and~     the surgical wound generated will be randomized to be closed with Clozex. A second keloid~     will be surgically excised and the surgical wound generated will be randomized to be closed~     with sutures. The inflammation index and the keloid recurrence rate at each surgical wound~     closure site will be compared.~   "
232176|NCT00517335|"~     This study will compare the brain's ability to distinguish between natural and artificial~     sweeteners in women with and without a history of eating disorders.~   "
231994|NCT00519714|"~     A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study. Following a~     6-8 week placebo and dietary-controlled baseline period, approximately 195 men and women with~     either hypertriglyceridemia or mixed hyperlipidemia with serum triglycerides (TG) > 200 mg/dl~     (2.26 mmol/l) will be randomized to receive either placebo, 30 mg 1-MNA or 90 mg 1-MNA three~     times daily for twelve weeks. Lipid and ancillary exploratory parameters will be evaluated at~     screening, during the baseline period, upon randomisation and throughout the 12-week active~     treatment period. Additionally, blood samples will be drawn at randomisation and at clinic~     visits during the active treatment period for sparse sampling population pharmacokinetic~     assessments. All blood samples for lipid assessments and glucose measurements will be~     collected following a 12-hour fast. Safety and tolerability will be assessed throughout the~     trial through the evaluation of physical exams, ECGs, routine hematology and blood chemistry~     testing, and adverse events.~   "
231995|NCT00519701|"~     The purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea~     therapy in children with Sickle cell Anemia between ages 18 months and 5 years, with special~     emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.~   "
231996|NCT00519688|"~     We hypothesize that combination of tegafur/uracil(UFUR) and thalidomide, both of which have~     been shown to be active in some HCC patients,may be a highly useful regimen for the treatment~     of advanced HCC. There are several rationales underlying this combination. First,~     anti-angiogenesis therapy may improve the efficacy of chemotherapy by normalizing the~     abnormal vasculature in tumors, and thus improving the delivery of chemotherapeutic agents to~     the tumor cells. Second, chemotherapeutic drugs given in a low-dose, un interrupted, and~     protracted way can induce anti-tumor effect through the anti-angiogenesis activity~     (so-calledmetronomic chemotherapy). The efficacy of metronomic chemotherapy can be~     suppressed by VEGF/VEGFR signaling pathways and thus can bo further potentiated by agents~     blocking those survival signals of endothelial cell. In this regard, tegafur/uracil appears~     to be a good candidate for metronomic chemotherapy because tegafur/uracil and its metabolites~     bave already been shown to inhibit angiogenesis in several pre-clinical models.~   "
231997|NCT00519675|"~     The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic~     hand eczema that is refractory to topical corticosteroids.~   "
231998|NCT00519662|"~     This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in~     humans.~   "
231999|NCT00519649|"~     The purpose of this study is to assess the persistence of immunity to hepatitis B in children~     who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol~     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
232000|NCT00519636|"~     The purpose of this replicate study to FFU105924 is to provide data on subject preference of~     FFNS as compared with FPNS.~   "
232001|NCT00519623|"~     This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an~     investigational basal insulin patch in type 1 diabetes patients.~   "
232002|NCT00519610|"~     The objective of this study is to evaluate the pre-operative symptoms and medical history of~     patients with portal hypertension who have undergone placement of H-graft portacaval shunts~     and correlate this with patient outcomes.~   "
232003|NCT00519597|"~     Obstructive sleep apnea (OSA) worsens the prognosis in patients with coronary artery disease~     (CAD). Many of these subjects do not report daytime sleepiness, and therefore, are not~     considered for OSA treatment with continuous positive airway pressure (CPAP). There is lack~     of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA.~     The Randomized Intervention with CPAP in CAD and OSA (RICCADSA) trial is designed to address~     if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction,~     stroke and cardiovascular mortality over mean follow-up period of 3-years in CAD patients~     with OSA without daytime sleepiness.Secondary outcomes include cardiovascular biomarkers,~     cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and~     1-year follow-up as well as polysomnographic findings and adherence to CPAP therapy.~   "
232004|NCT00519584|"~     This study will test the hypothesis that ropivacaine in combination with either systemic or~     local steroid provides comparably longer-lasting analgesia tha ropivacaine alone.~   "
232005|NCT00519571|"~     To investigate the safety and effectiveness of the ImplantLock device and its contribution to~     8.0 mm long root-form endosseous implants stability under immediately applied continuous~     functional loading.~   "
232006|NCT00519558|"~     This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the~     effect of NN-220 compared with that of placebo as assessed by the change in percent in~     truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with~     Growth Hormone Deficiency in Adults (GHDA).~   "
232007|NCT00519545|"~     The goal of this study is to help determine the biochemical mechanisms underlying previously~     demonstrated health benefits of prayer, and to track humoral changes in various prayer~     activities.~   "
232008|NCT00519532|"~     The objective of this open-label extension is to assess the long-term effect of the 24-hour~     transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and~     non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the~     rotigotine transdermal patch will also be evaluated.~   "
232009|NCT00519519|"~     Bleeding peptic ulcers are one of the major causes of morbidity and mortality for hospital~     emergency admissions.The initial treatment is endoscopic therapy followed by intravenous~     omeprazole. However the optimal dosage of omeprazole is not known. We conducted this study to~     find out the optimal dosage in such clinical scenario.~   "
232010|NCT00519506|"~     The aim of the study is to determine the diagnostic accuracy of 99mTc ThromboView® SPECT~     imaging for the detection of acute pulmonary embolism (PE) in patients for whom there is a~     moderate to high clinical suspicion for PE.~   "
232052|NCT00518960|"~     The purpose of this study is to determine the effectiveness of ProAlgaZyme in increasing~     levels of HDL 'good' cholesterol and decreasing total cholesterol and C-reactive protein in~     patients with Metabolic Syndrome.~   "
232177|NCT00517322|"~     Aim of the study is to compare in hypertensive patients the effect of one year therapy with~     ACE-inhibitor (RAMIPRIL) or angiotensin II receptor blocker (IRBESARTAN) on left atrial~     remodelling and diastolic function.~   "
232178|NCT00517309|"~     The primary purpose of the study is to test the safety of HPV Vaccine in Women~   "
232012|NCT00519480|"~     This study will assess safety and tolerability of metformin plus GSK189075 in people with~     Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if~     they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a~     run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a~     13-day treatment period, and a follow-up visit about 1 week after the treatment period.~     Volunteers will remain in the research clinic beginning 2 days before they receive the first~     dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of~     the 12th day of dosing until the morning after the last dose. They will have clinic visits on~     dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring~     their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart~     rate, laboratory tests on blood and urine, physical examinations, reports of drug side~     effects and ECGs will be obtained during the clinic visits to assess safety.~   "
232013|NCT00519467|"~     Drug resistance to a range of antimalarial treatments has become widespread in Africa, South~     East Asia and South America. Because the rapid spread of drug resistance threatens a public~     health disaster in these areas of the world and to comply with the WHO-Roll Back Malaria~     policy of using Artemisinin-based combination therapies (ACT), there is a need to develop~     new, safe, effective and affordable ACT.~      Chlorproguanil-dapsone-artesunate (CDA)is a new ACT that is being developed for the treatment~     of uncomplicated falciparum malaria in Africa.~   "
232014|NCT00519454|"~     This study involves research to investigate how estrogen affects women of childbearing age~     and its correlation to Systemic Lupus Erythematosus. The findings from this study might help~     determine how body cells, called T Cells, react to estrogen. The study will seek to determine~     if cells from women with Lupus, react differently from cells in persons without Lupus. We~     will attempt to identify genetic factors that determine the effects of estrogen on Lupus~     cells.~   "
232015|NCT00519441|"~     Patients who have had laparoscopic surgery for the treatment of achalasia will be asked to~     have pH studies done in order to determine is these patients suffer from reflux after~     surgery.~   "
232016|NCT00519428|"~     This study will utilize a randomized double-blind design to evaluate whether initial~     treatment with two anti-depressant medications (escitalopram and bupropion) results in more~     rapid remission and greater over-all remission rates than either monotherapy in 240 depressed~     subjects.~   "
232017|NCT00519415|"~     A new appliance will be used to transfer the tongue force during its physiological activity~     to advance the nasomaxillary complex; this method will be compared with the traditional~     method which uses a Facemask appliance.~   "
232018|NCT00519402|"~     Introduction: There is currently no long-term study, which compares the outcomes of partial~     tonsillectomy to conventional tonsillectomy. We hypothesize that there will be little~     significant tonsillar regrowth with partial tonsillectomy.~      Background and Significance: Tonsillectomy is the most common major surgical procedure~     performed on children in the United States with nearly 300,000 procedures performed each~     year, primarily for the indication of obstructive sleep disordered breathing (OSDB).~     Conventional (total) tonsillectomy removes the tonsillar capsule, and partial tonsillectomy~     preserves the capsule by shaving away the tonsils using an endoscopic microdebrider. Partial~     tonsillectomy results in less pain, fewer days to normal activity and diet, and fewer days of~     analgesics than total tonsillectomy. There are no significant differences between the~     techniques in blood loss or postoperative life improved Historical evidence suggests that~     eventually there will be tonsillar regrowth with partial tonsillectomy. However, in a 2003~     follow-up report of 243 children undergoing partial tonsillectomy and 107 undergoing complete~     tonsillectomy from 1998 through 2002 for OSDB there was no evidence of significant tonsillar~     regrowth. (1) We will follow-up children undergoing partial or complete tonsillectomies at~     the Cleveland Clinic from 1998 through 2002. There will be standardized tonsillar~     examinations by two observers, with a third observer in cases of significant disagreement,~     and questionnaires evaluating sleep apnea and daytime sleepiness, and number of tonsillar~     infections.~      If there are a large number of children with recurrent tonsillar symptoms post partial~     tonsillectomy, the procedure should be abandoned. However, if follow-up reveals comparable~     tonsillar symptoms for partial and the total tonsillectomy, perhaps the partial procedure~     should replace the total tonsillectomy as the standard operation to relieve tonsillar OSDB.~     This could eventually result in millions of less lost days of work and school in the United~     States.~   "
232019|NCT00519389|"~     This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the~     safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or~     placebo in healthy adults 18 to 40 years of age.~   "
232020|NCT00519376|"~     This study will involve the use of a new compound, GW642444 that is being developed for the~     treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on~     cells in the lungs, causing some of the muscles around the lungs to relax and open up better~     (bronchodilation), making breathing easier. When a medicine is made into a form ready to be~     given to patients, the active ingredient is often prepared in the form of a salt, and~     inactive ingredients (excipients) are often added. Inactive ingredients might be used to help~     a medicine work better, to make it easier to produce the medicine, or to make it easier to~     get an accurate dose of medicine. In previous studies the study drug has been given as a dry~     powder in the form of either the 'H' salt (with the excipient lactose), or in the form of the~     'M' salt (with the excipients lactose and cellobiose octaacetate). In this study the 'M' salt~     form of the study drug has been prepared with lactose and a new excipient called magnesium~     stearate (instead of cellobiose octaacetate). Participants in this study will receive both~     the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate. This~     study will be the first time the new 'M' salt form of the study drug will be given to COPD~     patients.~   "
232021|NCT00519363|"~     This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center~     for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if~     eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Statins~     have been shown to induce clinical improvement in rheumatoid arthritis patients, as well as~     lupus patients. The effectiveness has been noted within 8 to 14 days, we will do our study~     for 3 months. Clinical and laboratory tests will be checked at the 1 and 3 month interval. We~     hypothesize that statin drugs (atorvastatin) slow the progression of SLE(Systemic Lupus~     Erythematosus) disease activity and down regulates TLR(Toll-like receptors) 2,4,and 9~     pathways in addition to lowering lipid levels.~   "
232053|NCT00518947|"~     Verapamil has been found in some but not all studies to have antimanic activity. Therefore,~     we investigated the use of verapamil, alone or as an adjunctive treatment, in manic patients~     who did not respond to an initial adequate trial of lithium. Each study phase lasted three~     weeks. Subjects were treated openly with lithium in Phase 1 (n=45). Those who failed to~     respond were randomly assigned to double-blind treatment in Phase 2 with either verapamil~     (n=10) or continued lithium (n=8). Phase 2 responders were continued on the same medication~     in Phase 3. Phase 2 nonresponders (n=10) were assigned to combined verapamil/lithium in Phase~     3.~   "
232022|NCT00519350|"~     Patients undergoing major surgery, trauma or burns are prone to develop an exacerbated~     inflammatory response, which is potentially lethal to the individual. Recently, the~     researchers' group showed in a rodent model of hemorrhagic shock that high-fat feeding~     administered before shock attenuates inflammation and reduces intestinal and hepatic damage.~     In the mechanism that underlies this protective effect, the release of cholecystokinin in gut~     wall and activation of efferent vagus bundles are crucial events. Before investigating the~     effect of high-fat nutrition in clinical setting, suitable markers of inflammation and organ~     damage need to be selected. In this study, blood will be collected in patients undergoing~     different types of operations. Consequently several markers for inflammation and organ damage~     will be determined. Hence, suitable parameters for a future high-fat intervention study will~     be selected.~   "
232023|NCT00519337|"~     The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce~     inflammation following heart surgery.~   "
232024|NCT00519324|"~     The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in~     patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer)~     whose cancer has progressed despite prior treatment.~   "
232025|NCT00519311|"~     People with intellectual disability die five to twenty years earlier than the general~     population. They also experience high levels of unrecognised disease and receive inadequate~     levels of health promotion or screening. Although they comprise 2.7% of our population (502~     000 Australians) they receive scant, if any, attention in the health literature.~      The barriers to good health for this population include: communication difficulties, impaired~     recall of significant health information, and inadequate training of health service~     providers. This project attempts to minimise some of these barriers through the use of a~     Health Intervention Package. Use of this package has been evaluated in adults, but not in~     adolescents, with intellectual disability.~      The Health Intervention Package includes a comprehensive health review, called the~     Comprehensive Health Assessment Program (CHAP), which is performed by the adolescent's~     general practitioner, and a diary, the Ask diary, used to collect and store health~     information and to enhance health advocacy skills. We specifically aim to test if adolescents~     with intellectual disability using this package will receive better health screening and~     prevention (our primary outcomes). We also aim to test if using the package results in~     improved health advocacy by adolescents with intellectual disability and their parents (our~     secondary outcomes). The tool should also be acceptable to those involved (another secondary~     outcome). To investigate these aims we propose a clustered randomised controlled trial, a~     methodology we have used successfully in two previous trials. We will recruit 1000~     adolescents (and their carers and teachers) in Special Education Schools and Special~     Education Units in Queensland.~      The CHAP health review aims to produce shorter-term benefits of improved health~     screening/promotion and disease detection, such as increased sensory testing, identification~     of vision or hearing impairment, and improved immunisation rates. The Ask diary is intended~     to produce longer-term benefits such as improved communication about health matters, improved~     health advocacy skills, improved health record keeping, and increased health maintenance.~   "
232026|NCT00519298|"~     Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in~     healthy subjects.~   "
232027|NCT00519285|"~     Primary objective was to demonstrate overall survival improvement with aflibercept compared~     to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent~     prostate cancer (MAIPC).~      The secondary objectives were:~        -  To assess the efficacy of aflibercept compared to placebo on other parameters such~          prostate-specific antigen (PSA) level, cancer related pain, progression free survival~          (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);~        -  To assess the overall safety in both treatment arms;~        -  To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;~        -  to determine immunogenicity of IV aflibercept.~   "
232028|NCT00519272|"~     The goal of this behavioral research study is to look at the reasons that may prevent women~     from getting early treatment for their cervical cancer.~   "
232029|NCT00519259|"~     The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in~     healthy normal volunteers.~   "
232030|NCT00519246|"~     With the incremental trend of benign breast tumor, the surgical process of mastectomy was~     proceeded too much every day, especially in the Maternal Health Care Hospital, but whether~     the investigators can find another way to relieve the postoperative pain after such an~     operation is still unknown. The investigators hypothesized that the pain from the relatively~     small surgery may not be significant compared to different treatments, even if no drug was~     delivered to them. The investigators are enrolling patients who underwent mastectomy from~     benign breast tumor, and are observing the analgesic effects of different drugs.~   "
232031|NCT00519233|"~     The present study will investigate the safety, tolerability and spectrum of side effects of~     AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and~     potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.~   "
232032|NCT00519220|"~     The objective of this study is to review studies and patient symptoms before and after~     laparoscopic Heller myotomy to assess outcomes following laparoscopic surgery for achalasia.~   "
232033|NCT00519207|"~     The objective of this study is to determine the relative efficacy of sucrose, liposomal~     lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in~     newborn infants.~   "
232034|NCT00519194|"~     The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac~     Ablation System for treating permanent atrial fibrillation during concomitant open chest~     and/or open heart surgery for one of more of the following procedures: mitral valve repair or~     replacement, aortic valve repair or replacement, tricuspid valve repair or replacement,~     coronary artery bypass surgery or patent foramen ovale (PFO closure).~   "
232035|NCT00519181|"~     Reversible acetylation of the histone tails plays an important role in the control of~     specific gene expression. Mounting evidence has established that histone deacetylase~     inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and~     apoptosis in variety of cancer cells. In a single-center, one year open-label trial, 19~     HAM/TSP patients were treated with oral doses of VPA (20mg/Kg/day). Primary end-points were~     the therapeutic safety and the effect on HTLV-1 proviral load (a significant and sustained~     decrease was expected). Secondary end-point was the neurological status before and after~     one-year treatment.~   "
232054|NCT00518934|"~     The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis~     for patients with limb ischemia by transplantation of human cord blood mononuclear cells.~   "
232055|NCT00518921|"~     This is a multi-center and multi-national,randomized, double blind, placebo-controlled,~     28-day treatment study with BAY 68-4986 taken orally or a matching placebo.~   "
232056|NCT00518908|"~     Organ protection, volatile anesthetics, postconditioning, hepatic surgery~   "
232399|NCT00514306|"~     Multicenter, open-label, phase 1, cohort dose escalation study to determine the maximum~     tolerated dose (MTD) of 3 intermittent OSI-906 dosing schedules.~   "
232036|NCT00519168|"~     Recent research provides evidence that disrupted circadian rhythms, including hormonal~     patterns and sleep, are associated with increased risk of breast cancer incidence and faster~     progression to mortality. We have observed that a loss of normal diurnal cortisol rhythm~     associated with more awakenings during the night predicts early mortality with metastatic~     breast cancer. Other recent studies have shown that nighttime shift work is associated with~     higher breast cancer incidence, and in a murine model disrupting circadian cortisol cycles~     produced a doubling of implanted tumor growth. There is also recent evidence that abnormal~     clock genes are associated with cancer. However, it is not clear whether sleep disruption per~     se affects breast cancer progression, or whether such an effect is mediated by hormonal and~     immune dysregulation of this prevalent and hormone-mediated cancer. We propose to study sleep~     disruption as a prognostic factor in the progression of metastatic breast cancer. We will~     also examine sleep patterns in association with disrupted circadian rhythms of cortisol,~     ACTH, and melatonin as well as measures of immune function known to be salient to breast~     cancer progression. These are natural killer cell cytoxicity and specific cytokine, IL-6. We~     plan to recruit 105 women 45 years through 75 years with metastatic or recurrent breast~     cancer and 20 age and SES-matched controls for a two-week at home sleep study with Actiwatch~     and two nights of in-home EEG monitoring, followed by 28 hours of continuous blood sampling~     and one night of EEG sleep monitoring in our lab at Stanford. This will provide a full~     examination of circadian hormones associated with sleep patterns. We will relate these~     assessments to the subsequent course of breast cancer progression. Results of this study will~     provide specific evidence regarding how improved sleep management may affect the course of~     breast cancer. Aim 1: To study 24-hr diurnal rhythms of HPA axis hormones and melatonin in~     women with metastatic or recurrent breast cancer. Hypothesis 1: Women with metastatic or~     recurrent breast cancer will have reduced amplitude and disrupted phase of 24-hr diurnal~     rhythms of cortisol, ACTH, and melatonin. Aim 2: To describe sleep disruption in women with~     metastatic breast cancer and examine psychosocial, endocrine, and immune factors that may be~     associated with sleep disruption. Hypothesis 2: Women with metastatic or recurrent breast~     cancer will have a higher incidence of both at home and laboratory-examined sleep disruption~     than control women without breast cancer. Hypothesis 3: Poorer sleep quality will be~     associated with more pain, more emotional suppression in response to stressors, less~     emotional support, greater depression and anxiety, and greater perceived and traumatic~     stress. Hypothesis 4: Poorer sleep quality and quantity of sleep and daytime sleepiness and~     fatigue will be associated with abnormal circadian neuroendocrine (i.e., cortisol, ACTH, and~     melatonin) and immune patterns (i.e., suppressed day and night time NK activity and loss of~     NK rhythms; increased day time IL-6 levels and /or loss of IL-6 rhythm). Aim 3: To study the~     relationship between sleep disruption and survival time among metastatic and recurrent breast~     cancer patients. Hypothesis 5: Poorer sleep quality and quantity of sleep will predict~     shorter survival. Hypothesis 6: Reduced diurnal amplitude and an abnormal phase of cortisol~     will predict shorter survival. Explanatory Aim 4: To investigate whether sleep disruption~     mediates the relation of psychosocial factors to health outcomes.~   "
232037|NCT00519155|"~     The purpose of the study is to gain experience of safety and efficacy with MD05 in man in~     alveolar bone regeneration.~   "
232038|NCT00519142|"~     The primary objective of this study is to demonstrate whether mitiglinide administered in~     combination with metformin is more effective than metformin alone in patients with Type 2~     diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone.~     This is a 24 week study which measures improvement in blood sugar after of treatment.~   "
232039|NCT00519129|"~     Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the~     coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope~     while a traditional fluoroscopy device will only show instant pictures. We want to~     investigate whether the 3D-imager causes the patient less pain and is more time consuming~     than ordinary fluoroscopy~   "
232040|NCT00519116|"~     The study evaluated renal graft function (based on the calculated creatinine clearance) 6~     months after kidney transplantation in patients receiving either a regimen of 'reduced-dose'~     tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus +~     sirolimus + corticosteroids.~   "
232041|NCT00519103|"~     The aim of this study was to investigate the effects of physical exercise on gene expression~     in muscle biopsies from patients with chronic polymyositis or dermatomyositis~   "
232042|NCT00519090|"~     In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with~     imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their~     Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase~     (CML-CP).~   "
232043|NCT00519077|"~     The purpose of this study is to demonstrate the activity (response rate and rate of stable~     disease) of Iressa administered as a single agent escalated to a dose that produces grade 2~     skin toxicity in patients with recurrent and/or metastatic squamous cell carcinoma of the~     head and neck (SCCHN).~   "
232044|NCT00519064|"~     This phase III is designed to confirm the previous trial results evaluating the safety,~     clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines'~     adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic~     diseases.~   "
232045|NCT00519051|"~     A randomized clinical trial was carried out at primary care level in Santiago, Chile to~     compare a pharmacological intervention for depressed mothers controlled by phone from a~     central level (TM) and the usual treatment (TH) and its impact on children's mental health.~      Hypothesis: pharmacological intervention for depression controlled by phone from a central~     level will be more effective than usual care in depressed mothers.~   "
232046|NCT00519038|"~     The purpose of this study is to determine whether the use of clinical pathways improves the~     quality of the hospital care of decompensated heart failure patients.~   "
232047|NCT00519025|"~     This is a retrospective chart review study. The proposed study aims to document the risk~     factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally,~     the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be~     assessed.~   "
232048|NCT00519012|"~     Introduction and Purpose:~      Most of the guidelines for the treatment of major depression recommend the use of~     antidepressants for 4 to 8 weeks. On the other hand, it has been recently reported that they~     start to show their antidepressant efficacy within a couple of weeks (1,2), contrary to the~     conventional theory. In addition, a good response (i.e. a 20% reduction in the~     Montgomery-Åsberg Depression Rating Scale [MADRS]) at week 2 is proposed to be a predictor of~     subsequent remission at week 6 (3,4), while nonresponse at week 2 could predict unfavourable~     outcome at week 8 (5). Furthermore, early worsening is suggested to be related to a low rate~     of remission at weeks 8 and 12(6).~   "
232049|NCT00518999|"~     Longitudinal investigation of cognitive, emotional and illness awareness of schizophrenia~     outpatients (Shalvata Mental Health Center). The study uses computerized assessment of~     cognitive functioning and questionnaire to assess performance of patients assessed in the~     past as part of a routine clinical assessment.~   "
232050|NCT00518986|"~     The primary objective of the study is to evaluate whether armodafinil at a target dosage of~     200 mg/day is more effective than placebo treatment in improving excessive sleepiness in~     patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major~     depressive disorder or dysthymic disorder.~   "
232051|NCT00518973|"~     This research study is being held at UCSD to determine whether the medication Quetiapine~     helps people suffering from anorexia nervosa by reducing core eating disorders symptoms. This~     study will see if the medication Quetiapine helps symptoms of anxiety, depression, and~     obsessionality, in addition to increasing BMI. Men and women between the ages of 18-65 and~     are currently suffering from anorexia nervosa are needed.~   "
232058|NCT00518882|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to~     subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea~     or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week~     randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received~     liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both~     combined with OAD treatment.~   "
232059|NCT00518869|"~     The objective of this study is to evaluate the efficacy and safety of PG2 as a complementary~     treatment to conventional chemotherapy among NSCLC patients. In reference to previous~     studies, Clinical Benefit Response and Incidence of Grade III plus VI Neutropenia will be~     used as the primary endpoints in this study. Clinical Benefit Response is a metric~     measurement including change in cancer or cancer treatment related fatigue which is related~     to chronic fatigue syndrome (CFS), change in karnofsky performance status and change in~     weight. The secondary endpoints include patient's global quality of life, and the blood~     c-reactive protein level which is related to weight change, tumor response, survival time,~     incidences of myelosuppression (including neutropenia, anemia and thrombocytopenia) and the~     related G-CSF and antibiotics consumption.~   "
232060|NCT00518856|"~     We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training~     traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP)~     and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.~   "
232061|NCT00518843|"~     The primary hypotheses are:~        -  A procedurally distinct family therapy is an effective and essential way to reduce~          bingeing and purging in adolescents with BN, and leads to the long-term amelioration of~          bulimic symptoms.~        -  Family therapy is an effective way to bring about meaningful improvements in family~          interaction.~        -  Family therapy will produce significantly larger reductions in bulimic symptoms and~          improved family interaction in adolescents with BN compared to a control supportive~          psychotherapy.~   "
232062|NCT00518830|"~     A randomized clinical trial was carried out at primary care level in Santiago, Chile to~     investigate a combined treatment for women suffering post-natal depression and preventing the~     adverse consequences of this illness on infant's growth and development.~   "
232063|NCT00518817|"~     This study will have significant impact on muscular dystrophy patients as it promotes early~     screening for heart disease. With early identification, beneficial medical therapy can be~     started sooner, resulting in restoring and maintaining normal heart function. This is~     critical to the survival of these patients. We have reported previously that heart failure in~     all patients may have common mechanisms, the final common pathway. Heart failure is a~     significant health problem with 5 million people in the US carrying the diagnosis and~     accounting for 12-15 million office visits and 6.5 million hospital days per year. The number~     of deaths from heart failure continues to increase. The data from this study could impact~     patients worldwide with heart failure by offering new insight into an ever-growing disease~     population and lead to significant changes in how they are currently treated.~   "
232064|NCT00518804|"~     LAY SUMMARY:~      IBI is costly and there are currently long waitlists of children who are in need of~     treatment. The investigators have clinical and ethical obligations to determine more~     appropriate alternatives to IBI for children making few gains because all children with~     autism deserve treatment based on their needs. This study is designed to determine the~     effectiveness of a functional skills group intervention, based on the principles of applied~     behaviour analysis, for children responding slowly to IBI. Specifically, it will investigate~     the effectiveness of functional behavioural skills training in addition to IBI at increasing~     a child's independence in day to day communication and self-help skills and reducing~     behaviour problems, as well as increasing parental competence and decreasing caregiver strain~     compared with IBI alone. Having an effective alternative to IBI for children making few gains~     is relevant from the standpoint of i) preventing exposure to potentially intrusive~     interventions for those children making few gains in IBI, ii) allowing children making few~     gains in IBI to access effective treatment, iii) opening limited IBI spots for children who~     would benefit from IBI, and iv) making better use of limited health resources. Overall, the~     results will be of interest to parent, clinicians, researchers and funding bodies.~      HYPOTHESES~      Four main hypotheses are presented to examine the effectiveness of involvement in the ABA~     functional skills group in improving parent training and functional skills and behaviour in~     young children with ASD who do not master the ELM. We focus our hypotheses on child measures~     of functional self help skills, behaviour and cognition as well as parental measures of~     caregiver strain and sense of competence.~      Participants (i.e. children predicted to have poor response to IBI alone) who attend the~     functional skills group for 8 months will have:~        1. greater decreases in interfering behaviour as measured on the Developmental Behaviour~          Checklist and ratings of behaviour during observations compared to children receiving~          IBI alone.~        2. greater increases in self-help as measured on the Vineland Adaptive Behaviour Scales II,~          and greater independence in eating, toileting, requesting, hand washing, and responding~          to name as measured by independent ratings of these skills compared with those children~          receiving IBI alone.~        3. parents of these children will have greater improvements in their sense of competence as~          a parent and greater reductions in caregiver strain, compared with parents of children~          receiving IBI alone.~        4. a similar pattern of little or no change in cognitive function compared with children~          who receive only IBI based on the Stanford Binet. In other words, there will be no~          difference between the experimental and control group on the measure of cognitive~          functioning~   "
232065|NCT00518791|"~     The aim of the present study is to evaluate the (cost) effectiveness of a new health care~     system in which an individualised multidisciplinary assessment is given to patients with~     Parkinson's Disease(PD)in combination with treatment by a dedicated team of specifically~     trained health professionals, compared to usual care. Overall, we anticipate to gain more~     insight in the clinical effectiveness and health care costs of multidisciplinary treatment in~     PD.~   "
232066|NCT00518778|"~     This exempt chart review study will try to determine the clinical presentation, prognostic~     factors, response to different treatment modalities and mortality among patients diagnosed~     with fusariosis after solid-organ transplantation.~   "
232067|NCT00518765|"~     This study will measure the effects of different doses of aliskiren on kidney blood flow and~     function in healthy adults and determine how salt intake affects the response to aliskiren.~   "
232068|NCT00518752|"~     The purpose of this study is to compare how effective different ways of mouth cleaning are~     for patients in a neuroscience intensive care unit with a breathing tube in their mouth.~   "
232069|NCT00518739|"~     This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II~     Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.~   "
232070|NCT00518726|"~     To evaluate the antibody response to each influenza vaccine antigen when administering a~     single dose to subjects aged > 18 years~   "
232086|NCT00518518|"~     The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied~     preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to~     grass pollen. The investigators will assess clinical symptoms, reliever drugs usage, lung~     function, chosen markers of allergic inflammation, bronchial hyperreactivity with~     methacholine, and presence and type of allergy after two years of sublingual immunotherapy~     (SLIT) in children with asthma.~   "
232071|NCT00518713|"~     The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive~     therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2~     to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at~     approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly~     assigned to either a low, medium or high dose, or placebo. The study will include a baseline~     period, a titration period and a maintenance period. After the maintenance period, patients~     will either continue into an open-label extension study or enter the taper period with a~     final visit 1 week after the last dose.~   "
232072|NCT00518700|"~     To compare corneal staining after contact lens instillation with a new MPS vs. RepleniSH~   "
232073|NCT00518687|"~     This study will assess the efficacy of a single dose of V710 vaccine to prevent serious~     Staphylococcus aureus infections following elective cardiothoracic surgery. The study will~     also evaluate the immune response and general safety of the V710 vaccine.~   "
232074|NCT00518674|"~     The aim of this randomized, double-blind and placebo-controlled study is to evaluate the~     specific role of injection of local anesthetic into the intra- vs. extraarticular tissues~     after toal knee arthroplasty.~   "
232075|NCT00518661|"~     This is a retrospective chart review. This proposed study aims to document the risk factors~     for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the~     adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be~     assessed.~   "
232076|NCT00518648|"~     The REFINE-PD study is a controlled trial embedded within a larger cluster controlled study~     (the IMPACT study). The study aims to investigate the efficacy of a multifactorial falls~     prevention program for patients with Parkinson's Disease (PD). This program contains~     PD-specific elements (e.g., optimizing dopaminergic therapy), plus a generic falls prevention~     program. The intervention will be tailored to each individual's specific risk profile for~     falls, as identified during detailed baseline examination.~   "
232077|NCT00518635|"~     Study hypothesis:~      Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor~     (IGF)-I, can improve insulin sensitivity and the metabolic profile of women with polycystic~     ovary syndrome.~      Study aims:~      To determine the mechanism of how low dose GH treatment affects the body's sensitivity to~     insulin actions and whether this low GH dose can affect the body's handling of steroid~     hormone levels (cortisol clearance) and testosterone (male hormones) in obese women with~     polycystic ovary syndrome.~      Study design:~      Obese women with polycystic ovary syndrome, but not recently been on GH treatment, and~     presently attending Outpatients Clinic will be invited to participate in this study. The~     subjects will be assessed at the initial visit to ascertain their suitability before further~     participating in the study. If suitable, an equal number of women will be randomized to~     receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging~     over for another 12 weeks of treatment after a 4-week washout period. Before, during and~     after treatment, the subjects will be assessed at frequently with blood tests, scans and fat~     biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and~     Translational Research Institute (OCTRI). At the first, second and final visit, testing will~     include scans to measure the amount of whole body fat and fat in the stomach area, muscle,~     and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy)~     analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by~     growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in~     the body (insulin sensitivity) will be collected at all visits of the study.~   "
232078|NCT00518622|"~     The purpose of this study is to investigate the effectiveness, safety, and tolerability of~     MK7009 in patients infected with Hepatitis C~   "
232079|NCT00518609|"~     India, with one of the world's largest populations, continues to struggle with extremely high~     infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent~     of deaths among community-born (and 20 percent of mortality among hospital-born) infants.~     This study is the first phase of a multi-phase project investigating interventions to prevent~     neonatal infection in India.~   "
232080|NCT00518596|"~     India, with one of the world's largest populations, continues to struggle with extremely high~     infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent~     of deaths among community-born (and 20 percent of mortality among hospital-born) infants.~     This study is the first phase of a multi-phase project investigating interventions to prevent~     neonatal infection in India.~   "
232081|NCT00518583|"~     The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and~     trastuzumab in patients with operable breast cancer. Patients will be treated with the~     combination for 18 weeks, followed by surgery.~   "
232082|NCT00518570|"~     The purpose of this study is to investigate the clinical efficacy of Levetiracetam in the~     treatment of symptoms of premenstrual dysphoric disorder (PMDD) in an open label study.~   "
232083|NCT00518557|"~     The purpose of this study is to investigate safety and potential therapeutic benefits for~     patients with hepatocellular carcinoma by transcatheter chemoembolization with the~     recombinant endostatin (commercially available in China)which is also administrated via the~     hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment~     may inhibit the proangiogenic effects induced by the hypoxia of TACE.~   "
232084|NCT00518544|"~     Background: Individuals with type O blood have reduced factor VIII and von Willebrand factor~     levels compared to the non-O counterpart. Infusion of hydroxyethyl starch (HES) impairs~     coagulation and, in O blood type, apparent coagulopathy can develop after HES infusion. A~     newly market-released balanced HES (670/0.75) has physiologic pH and balanced electrolytes~     including calcium, which are beneficial to coagulation. Studies comparing balanced HES~     (670/0.75) with saline-based HES (130/0.4), previously known the least coagulopathic are~     rare. Therefore, we try to reveal the difference of coagulation, pH/electrolyte balance, and~     bleeding amount between the non-O and O blood types after infusion of these two newest HES.~      Methods: Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery~     involving 2 or 3 spinal levels were enrolled. 20 ml/kg of saline-based HES (130/0.4) or~     balanced HES (670/0.75) was administered during operation. Blood loss, coagulation and~     metabolic profiles were checked at pre-infusion (T0), 5 min after infusion (T1), 4 hrs after~     infusion (T2) and 24 hrs after infusion (T4).~   "
232087|NCT00518505|"~     The purpose of this study is to review pre-operative studies and patient evaluation reports~     and compare those with the results of the post-operative studies, patient evaluation reports~     and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux~     disorder. This will allow us to evaluate how patients have benefited from the procedure.~   "
232088|NCT00518492|"~     Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent~     for this duration of immunity study to provide up to two additional blood samples. SBA & IgG~     testing will be done on these samples taken at 6 & 12 months. The sites participating in this~     duration of immunity study are the same sites participating in the 6108A1-500 study.~   "
232089|NCT00518479|"~     Uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the~     likelihood of complications and death. The high blood pressure explains some but not all of~     this increase in heart size. This study will investigate the other causes, and will measure~     the heart muscle 'thickness' very accurately using the latest and most accurate technique~     called cardiac magnetic resonance imaging (MRI). The best way to treat this heart thickening~     remains to be determined. We hope to be able to show that by specifically targeting the cause~     of heart muscle thickening we can reduce its occurrence more effectively than by other~     standard means of blood pressure treatment~   "
232090|NCT00518466|"~     The primary objective of this study is to describe the single- and multiple-dose~     pharmacokinetic profiles of two novel formulations of topiramate and commercially available~     immediate release topiramate, all dosed with immediate release phentermine.~   "
232091|NCT00518453|"~     Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines~     are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and~     tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical~     trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).~   "
232092|NCT00518440|"~     The purpose of this study is to collect clinical and epidemiological data as well as serum,~     plasma, urine, tissue and DNA samples on individuals who have acute liver failure and on~     individuals who have acute liver injury, a less severe group of patients who have~     coagulopathy but do not reach the threshold of encephalopathy.~   "
232093|NCT00518427|"~     Primary objective:~      To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation~     in patients with Type 2 diabetes inadequately controlled on a combination of oral~     antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are~     switched to insulin glargine.~      Secondary objective:~      To determine:~      change in HbA1c, comparision of the incidence of symptomatic hypoglycemia and severe~     hypoglycemia before and after introduction of insulin glargine, change in weight, change in~     insulin dose.~   "
232094|NCT00518414|"~     Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.~   "
232095|NCT00518401|"~     The purpose of this research study is to determine if the transplant of a combination of stem~     cells obtained from the bone marrow of the same patient will contribute to the formation of~     new blood vessels in the severely diseased ischemic limb (leg). In this study the safe use of~     this combination of stem cells and its effects on making new blood vessels will be evaluated.~      Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decreases blood~     flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain~     and even skin ulcers or sores.~      LI needs comprehensive treatment since the condition will not improve on its own. The overall~     goal of treatment is to reduce the pain and increase blood flow to improve symptoms or save~     the leg or feet. In many cases, current options for treatment including medications, surgery~     or endovascular procedures have not been successful.~      In the last few years, investigators have explored therapies aimed to increase blood flow to~     the ischemic vessels by transplanting cells that will promote the development of new vessels~     in the diseased leg.~      The study hypothesis is based on the concept that the process of formation of new blood~     vessels is complex and requires the participation of several types of stem cells and growth~     factors. The lack of any of these components will produce vessels which are immature and~     unable to provide appropriate blood supply to the leg.~      Patients eligible to participate in this study are those suffering from poor circulation or~     severe leg blockages, which are not candidates for surgical procedures.~      Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will~     be transplanted into the calf muscle of the diseased leg. Clinical studies to evaluate if the~     transplant works and is safe will be performed up to 1 year after cell transplant.~   "
232096|NCT00518388|"~     The goal of this research study is to learn about the beliefs, practices, and knowledge about~     cervical cancer among Asian American young adults. Researchers want to develop materials that~     will educate Asian Americans about cervical cancer and encourage them to get screened for~     this disease.~   "
232097|NCT00518375|"~     This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months~     after transplantation in patients receiving either a regimen of reduced dose or standard dose~     cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft~     rejection at 6 and 12 months following transplantation and patient and graft survival at 12~     months were evaluated also.~   "
232098|NCT00518362|"~     The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus~     Valsartan (ARB) in the Diabetic Nephropathy (DN).~   "
232099|NCT00518349|"~     A prototype colonoscope with an extra passively bending distal section has been developed by~     Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of~     this function.~   "
232100|NCT00518336|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy,~     safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of~     women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having~     participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in~     the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects~     were aged 15-25 years at the time of entry into the primary study.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
232117|NCT00518115|"~     This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are~     either taking no diabetes medication or who are taking metformin only. This study will~     investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will~     measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16~     weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide~     (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up~     visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring~     of any side effects.~   "
232101|NCT00518323|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of 3~     weight-based, fixed-dose groups of paliperidone extended release (ER) compared with placebo~     in adolescent patients between 12 to 17 years of age, who are diagnosed with schizophrenia.~     Paliperidone ER is an atypical antipsychotic agent approved by the U.S. Food and Drug~     Administration for the treatment of schizophrenia in adults. Patients may be voluntary~     inpatients or outpatients at the time of the screening visit, but should have returned to~     their usual living situation by Day 21 of the double-blind treatment phase. The study~     duration is approximately 10 weeks. Patients who have completed this study or who were~     discontinued from this study due to lack of efficacy but have completed at least 21 days of~     double-blind treatment and are expected to benefit from paliperidone treatment, may enter an~     optional open-label safety study.~   "
232102|NCT00518310|"~     Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease, associated with the~     histological appearance of usual interstitial pneumonia (UIP), with an inexorably~     deteriorating clinical course. Prognosis is poor, reported median survival is less than 3~     years. The prevalence is estimated as being 3 to 10 per 100.000 in different Western~     populations. To date, no pharmacological therapy has been proven to alter or reverse the~     pathogenic process of IPF. Most treatments trials have been observational case series of~     small patient populations and very few have been randomized, prospective and~     placebo-controlled.~      Two recent Cochrane reviews investigated the role of corticosteroids and other~     immunomodulatory agents and concluded that there is no evidence for their use in IPF. Most~     current therapies are targeted to suppress the inflammatory component of the disease, based~     on the theory that it would be chronic alveolar inflammation which leads to parenchymal~     remodeling and fibrosis. Recently, a hypothesis that has gained acceptance suggests that~     fibrosis may result directly from alveolar injury, promoting an abnormal fibrogenic repair~     mediated by fibroblasts and myofibroblasts.~      One of the cytotoxic agents most widely used and better tolerated in the management of IPF is~     azathioprine. Based upon limited data available and from a single small high quality~     randomized controlled trial (RCT), this drug appears to confer, given in conjunction with~     prednisone, a marginal long term survival advantage. Since this combination therapy is~     associated serious adverse effect, we planned to design a trial of low dose corticosteroid~     and azathioprine versus placebo in management of IPF, evaluating progression-free survival.~      Our study hypothesis is: Combined therapy with azathioprine and corticosteroids improves~     progression-free survival in patients with the diagnosis of IPF.~   "
232103|NCT00518297|"~     The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of~     raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300~     mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without~     raltegravir 400 mg BID.~   "
232104|NCT00518284|"~     The purpose of this study is to investigate the prevention of Restenosis following~     Revascularization of the superficial Femoral Artery (SFA)~   "
232105|NCT00518271|"~     This study evaluated renal graft function based on calculated creatinine clearance at 6~     months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose~     tacrolimus plus sirolimus and corticosteroids.~   "
232106|NCT00518258|"~     The purpose of this study is to investigate similarities and differences in the neural~     pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy~     controls using magnetic resonance imaging (MRI) of the brain and neuropsychological~     assessment.~   "
232107|NCT00518245|"~     The purpose of this study is to determine whether enoxaparin (an anticoagulant) is effective~     in the treatment of patients presenting to the emergency room with chest pain and no~     electrocardiogram or bloodwork evidence of a heart attack, but with other high risk clinical~     features~   "
232108|NCT00518232|"~     The purpose of the study is to investigate the clinical benefit of switching children with~     ADHD from immediate-release methylphenidate (IR-MPH) to OROS-methylphenidate under the~     correct dosage conversion scheme.~   "
232109|NCT00518219|"~     The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment~     of heavy proteinuria of membranous nephropathy.~   "
232110|NCT00518206|"~     This was a Phase 2, open-label study of the NY-ESO-1 ISCOMATRIX® (ISCOM) vaccine administered~     as an intramuscular injection given every 4 weeks to subjects with measurable advanced~     malignant melanoma. Study objectives included determination of the anticancer activity,~     cellular and humoral immunogenicity, and safety and tolerability of the NY-ESO-1 ISCOM~     vaccine administered alone or preceded by a single administration of low-dose~     cyclophosphamide.~   "
232111|NCT00518193|"~     The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association~     cisplatine - topotecan .~      News thérapeutics are needed in the goal of increase the survival and quality of life in~     patients with cervix cancer.~      Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.~      Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate.~     Many clinical trials shown the faisability of the association of cetuximab and cisplatine in~     cancer.~      Many clinical trials have shown the faisability of association of cetuximab and irinotecan in~     colorectals metastatiques cancers .~   "
232112|NCT00518180|"~     This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY~     conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents~   "
232113|NCT00518167|"~     The aim of this study is to clarify whether lifestyle intervention provided to people with~     high type 2 diabetes risk will lower the cumulative incidence of diabetes. Furthermore, the~     aim is to study the effect of lifestyle intervention on cardiovascular risk.~   "
232114|NCT00518154|"~     The purpose of this study is to determine whether the addition of Pyridostigmine to Highly~     Active Antiretroviral Therapy (HAART) increases the number of CD4+ T-cells in discordant~     patients in which viral load diminishes, but T-cell levels remain low after the initiation of~     treatment.~   "
232115|NCT00518141|"~     This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and~     Terbutalin on ART treatment.~   "
232116|NCT00518128|"~     The goal of this research is to improve our understanding of the effectiveness of surgical~     OSA treatment by evaluating its impact on these health-related and functional outcomes and~     comparing these effects to the changes in respiratory physiology achieved after surgery. To~     achieve this goal, we will examine key health-related (C-reactive protein, homocysteine,~     leptin, the homeostasis model of insulin resistance, and heart rate variability) and~     functional (sleep-related quality of life and vigilance) measures among a surgical group of~     OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a~     comparison group of matched OSA patients who tolerate PAP.~   "
247293|NCT00316121|"~     The purpose of this study is to determine the safety and effectiveness of HEALOS compared~     with autograft using the transforaminal lumbar interbody fusion (TLIF) method.~   "
232120|NCT00518076|"~     The Staphylococcus aureus is an important pathogen bacteria actuating as an agent of a wide~     variety of infections, such as the superficials to the disseminates ones, its commonly find~     into hospitals ambient, assailing mainly immunosupress patients. Around 30% to 50% of people~     carries this agent in their nasal bone as part of their normal flora, occuring larger in~     hospitals workers. The S. aureus is also known for its high capacity of developing resistance~     to various antibiotic. Facing these considerations, the importance of nursing precaution and~     the infections control inside hospitals ambient, the purpose of this present study aimed to~     verify the rates of carriers of S. aureus in nursing students and the connection with the~     hospitals time involvement during graduation in the Faculty de Medicine de Botucatu - UNESP,~     embracing the 4 years of graduation college.~   "
232121|NCT00518050|"~     The purpose of this study is to examine the health behaviors of melanoma survivors. We want~     to know about their thoughts and concerns. Melanoma is a type of skin cancer. The number of~     people being diagnosed with melanoma is growing. Many people who are diagnosed with melanoma~     are young. Little research has been done to find out how melanoma survivors feel years after~     they have been treated.~   "
232122|NCT00518037|"~     The goal of this study is to learn more about the physical discomfort, sensory impairment,~     depression, anxiety, and interference with relationships, family, and work associated with~     NMSC via survey questions.~   "
232123|NCT00518024|"~     Tinnitus, i.e., the perception of sounds or noise in the absence of auditory stimuli, is a~     frequent and often severely disabling symptom of different disorders of the auditory system.~     There are currently no causal treatments. Using repetitive transcranial magnetic stimulation~     (rTMS), we have previously demonstrated that the temporoparietal cortex is critically~     involved in tinnitus perception and that tinnitus can be reduced by rTMS applied to these~     cortical regions. Therefore, it is reasonable to test rTMS as a potential new treatment~     strategy against tinnitus. At this stage, small pilot studies indicate some effect on~     tinnitus impairment but the reduction is predominantly reported to be transient, with high~     interindividual variability, and questionable clinical relevance. Moreover, the optimal~     stimulation area is unclear.~      Here, we use theta burst stimulation (TBS), a new rTMS paradigm for the prolonged modulation~     of cortical activity. The aim of this study is to test safety and effectivity of 4 weeks of~     daily bilateral TBS to two cortical areas on chronic tinnitus compared to sham-stimulation.~   "
232124|NCT00518011|"~     This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared~     with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced~     non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po~     daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine~     monotherapy. The anticipated time on study treatment is until disease progression, and the~     target sample size is 100-500 individuals.~   "
232125|NCT00517998|"~     The purpose of this study is to evaluate the safety and efficacy of the Biologic Lung Volume~     Reduction System (BLVR) for patients with advanced emphysema refractory to medical therapy.~   "
232126|NCT00517985|"~     Recently, antidepressants have been explored as a class of medications to treat major~     depression in the context of perimenopause, as well as the somatic symptoms of perimenopause~     (such as hot flashes). Duloxetine (Cymbalta) is one of the newer antidepressants approved for~     the treatment of Major Depressive Disorder (MDD). Therefore, the current study is designed to~     assess the efficacy of duloxetine in a sample of women who are perimenopausal and meet~     criteria for MDD. We will assess impact on MDD and perimenopausal symptoms.~   "
232127|NCT00517972|"~     Recently, antidepressants and other similar acting agents have been explored as a class of~     medications to treat major depressive disorder (MDD) in the context of perimenopause, as well~     as the somatic symptoms of perimenopause (such as hot flashes). Omega-3 fatty acids, which~     include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are nutritional compounds~     with widely established health benefits and which occur naturally in fish and marine sources.~     Results of previous mood disorder studies have indicated that omega-3 fatty acids may be of~     help in the treatment of depression. Therefore, the current study is designed to examine the~     effectiveness and tolerability of the study drug, Omacor, (omega-3 fatty acid ethyl esters),~     in the treatment of major depressive disorder in perimenopausal women.~   "
232128|NCT00517959|"~     Brain tumours are the commonest solid tumours in children and the second most common~     neoplasms overall in this patient population. Radiotherapy plays an important part in the~     management in a majority of these tumours. While the cure rates of these tumours, especially~     the benign and low grade ones are quite encouraging, the treatment itself may lead to some~     late sequelae, which could have significant implications in the quality of life in these~     long-term survivors.~      Stereotactic conformal radiotherapy (SCRT) is a modern high-precision radiotherapy technique,~     which reduces the volume of normal brain irradiated and has the capability to minimise the~     doses to critical structures. The present study is designed to prospectively estimate the~     incidence and severity of neuropsychological, cognitive and neuroendocrine dysfunction~     following radiotherapy delivered with conventional and stereotactic techniques and would be~     one of the most comprehensive studies providing very important longitudinal and reliable data~     regarding these sequelae. The study involving 200 patients would be to the best of our~     knowledge not only the largest ever study conducted so far but also the only randomised trial~     assessing these sequelae in patients receiving focal brain irradiation.~      The study also examines whether the physical advantages of modern technological progress~     translate in clinical benefit. This could have significant implications in the~     radiotherapeutic management of children and young adults with brain tumours. The study is~     unique in design in terms of evaluating the efficacy of SCRT with respect to conventional~     radiotherapy in terms of long term tumour control and treatment related complications.~   "
232129|NCT00517946|"~     The purpose of this study is to establish whether MRI scanning is a sensitive measure of the~     effects of existing drug treatments on nasal dimensions following challenge with intranasal~     allergen in subjects with hayfever. If successful this technique could be applied to increase~     confidence for internal decision making and ultimately may be used to assess how effective a~     new drug treatment is.~   "
232130|NCT00517933|"~     Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's~     ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication~     that increases blood flow to the lungs, at improving breathing function, exercise capacity,~     and quality of life in people with advanced IPF.~   "
232132|NCT00517907|"~     The primary goal of this study is to determine the safety and tolerability of a novel peptide~     - preimplantation factor (PIF-1) - in patients who develop acute steroid-resistant~     graft-versus-host disease (GVHD) after matched bone marrow transplant (BMT).~      Following matched BMT, patients will be placed on standard GVHD preventive therapy~     (cyclosporine); those who do not respond to cyclosporine are placed on a high-dose steroid~     regimen for 3 days. Patients that do not respond to this standard treatment will be given~     PIF-1 subcutaneously for 14 days.~      Clinical data and samples will be collected, during PIF-1 administration and for an~     additional three months thereafter, to examine the long-term effect of PIF-1 treatment on the~     patients' GVHD status.~   "
232133|NCT00517894|"~     To investigate if a dose-dense chemotherapy with weekly chemotherapy compared to standard~     treatment every 3 weeks results in better survival in aggressive non-Hodgkin's lymphoma.~   "
232134|NCT00517881|"~     This single arm study will assess the efficacy, safety and tolerability of subcutaneous~     methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in~     pre-dialysis participants with chronic renal anemia. Participants currently receiving~     maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous~     injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived~     from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.~   "
232135|NCT00517868|"~     A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary~     frequency following administration of URG101 compared to placebo.~   "
232136|NCT00517855|"~     This study is the second human clinical study with PRTX-100. It is designed to assess the~     safety of a single intravenous (IV) dose of PRTX-100, as well as, how the drug is eliminated~     from the blood after dosing. Additionally, this study provides an opportunity to monitor~     immune system response to PRTX-100.~   "
232137|NCT00517842|"~     The investigational product is a specially formulated TCM and administered in the form of a~     capsule.~      Basic pre-clinical studies have suggested that it may have good immunomodulating functions,~     increases the activities of T-cells, B-cells and NK cells, enhances mitochondrial antioxidant~     status on various tissues including brain tissues. Therefore, this formulation may have~     special values in improving symptoms in Parkinson's disease patients.~      The purpose of the study is to determine the efficacy and safety of ViNeuro in patients with~     Parkinson's disease.~   "
232138|NCT00517829|"~     The purpose of this research study is to find out what effects (good and bad) docetaxel,~     oxaliplatin, and cetuximab have on gastric or GEJ cancer.~   "
232139|NCT00517816|"~     This 8 arm study will evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single ascending doses of R1671 or placebo in patients with mild,~     intermittent, asymptomatic asthma. Patients will be randomized to receive placebo or R1671,~     at a starting dose of 0.0015mg, by intravenous infusion; this dose will be escalated in~     subsequent groups of patients after a satisfactory assessment of the data from the previous~     dose. The anticipated time on study treatment is <3 months, and the target sample size is~     <100 individuals.~   "
232140|NCT00517803|"~     We hypothesize that micronutrient fortified probiotic yogurt can improve nutritional status~     and enhance immunity parameters in subjects HIV/AIDS and other immunodeficiencies.~      We have developed a micronutrient-fortified probiotic yogurt that has safe and beneficial~     levels of micronutrients for human consumption. This has been undertaken with the guidance of~     Edward Farnworth, a senior research scientist at Agri-Food Canada-Food Research and~     Development Centre, St. Hyacinthe, Quebec~      We will now measure nutritional parameters (height, weight, serum albumin, serum nutrient~     levels, blood urea, liver function tests (AST, ALT)) to determine if there is a statistically~     significant difference between the various levels of fortified probiotic yogurt and the~     placebo on the nutritional parameters of the subjects consuming the yogurt.~      We will measure immunological parameters (CD4 lymphocyte count, CBC, levels of TNFα, IL-12,~     IL-10, and G-CSF [Kim, et.al. 2006]) in order to determine if there is a statistically~     significant difference using fortified probiotic yogurt compared to a placebo.~      In addition, we will determine if the micronutrient-fortified probiotic yogurt has a~     significant impact on the overall quality of life for the subjects using the linear analogue~     self assessment tool [Kaiser, et.al 2006].~   "
232141|NCT00517790|"~     The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.~   "
232142|NCT00517777|"~     To assess in moderate to severe Obstructive Sleep Apnea the effects of one year therapy with~     nighttime continuous positive airway pressure ventilation on the prevalence of metabolic~     syndrome and cardiovascular damage.~   "
232143|NCT00517764|"~     The Blue Sky Project, a 5-year study funded by the Canadian Institutes of Health Research,~     seeks to examine how genetics and early life experiences work together to cause a person's~     very first onset of depression by increasing sensitivity to stress.~   "
232144|NCT00517751|"~     This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS~     patients is designed to supplement pre-market safety and effectiveness data with information~     on longer-term device performance in a population of patients with moderately impaired~     physical function at preoperative baseline (i.e., an indicated population) who elect to~     undergo X STOP PEEK surgery.~   "
232145|NCT00517738|"~     Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that~     the same effect happens in patients with cirrhosis and portal hypertension. Hepatic~     encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The~     intention of this study is to assess if patients can improve their QOL and hepatic~     encephalopathy during a physical training program, and to address its safety.~   "
232146|NCT00517725|"~     The investigators test the hypothesis that different beta-blockers had a different influence~     on chemoreceptor response and lung diffusion capacity.~      Both could influence exercise capacity in normoxic as well as hypoxic conditions.~   "
232179|NCT00517296|"~     This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can~     improve durable fistula healing in patients with Crohn's perianal fistulas and to get~     preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal~     fistulas.~   "
232220|NCT00516711|"~     This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after~     sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury~     is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory~     mediators).~   "
232147|NCT00517712|"~     There is very limited data on the use of arsenic trioxide in newly diagnosed patients with~     acute promyelocytic leukemia. The use of arsenic trioxide was limited to relapsed patients~     mainly because of the superior efficacy of ATRA as primary therapy for newly diagnosed APML.~     Though the early study by Niu et al showed 72% remission rates in 11 newly diagnosed~     patients, the role of arsenic trioxide as primary therapy was limited by the hepatic toxicity~     seen in this study. Studies from our centre have shown remission rates of 70-75% in newly~     diagnosed patients with acute promyelocytic leukemia. There was no major toxicity seen~     related to the administration of arsenic trioxide. Follow up data on these patients continue~     to show long term remission rates above 70%. These remission rates are similar to the data~     available in patients with acute promyelocytic leukemia treated with ATRA. Lu et al studied~     19 patients treated with oral arsenic (Tetra-arsenic tetra-sulfide) wherein 84% achieved~     hematological remission with disease free survival of 76% at 3 years. Studies from other~     groups using arsenic trioxide alone or in combination with ATRA have shown similar remission~     rates. Arsenic trioxide as primary therapy for patients with newly diagnosed acute~     promyelocytic leukemia is a very attractive treatment option for developing countries mainly~     because of the low cost involved along with the favorable toxicity profile. However long term~     remission data is still not available and the ideal course and duration of treatment still~     needs to be defined. This multi-center study aims to further clarify the efficacy of this~     agent in the treatment of newly diagnosed cases of acute promyelocytic leukemia and to study~     the optimal maintenance regimen.~   "
232148|NCT00517699|"~     This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus~     high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible~     patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus~     methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week~     11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample~     size is <100 individuals.~   "
232149|NCT00517686|"~     The primary research question of this study is to determine whether measuring, reporting and~     feeding back information to primary care teams on the need for treatment intensification in~     patients at high risk for cardiovascular disease (CVD) can improve rates of treatment~     intensification and reduce levels of poorly controlled systolic blood pressure, LDL-c, and~     A1c.~   "
232150|NCT00517673|"~     GSK945237 is the first molecule of a new chemical class that is being developed for treatment~     of respiratory tract and other infections such as skin and soft tissue. This study drug has~     been tested in animals but has never been given to humans. This is a two part study. The~     purpose of the first part is to study the side effects of this drug in humans, and to study~     how much of the drug gets absorbed in the blood stream The second part of this study will~     compare absorption of the study drug in the blood stream when given with food and when given~     under fasting conditions~   "
232151|NCT00517660|"~     To characterise the physical parameters (number concentration, size distribution and their~     trajectories) of aerosols (droplets) generated in high risk procedures.~   "
232152|NCT00517647|"~     The purpose of this study is to determine if atomoxetine (a common brand name is Strattera),~     a medicine that is used for treating older children with Attention Deficit and Hyperactivity~     Disorder (ADHD), is also safe and helpful for ADHD problems in young children. While~     atomoxetine is not approved by the FDA for use in children younger than 6 years, the FDA has~     given permission to study this drug in this age group.~   "
232153|NCT00517634|"~     The aim of the present study is to investigate whether the effects of salmeterol in~     combination with fluticasone propionate on blood markers of airway inflammation are~     maintained after chronic dosing and whether the effect is influenced by the time of allergen~     challenge relative to the time of dosing.~   "
232154|NCT00517621|"~     validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the~     incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with~     paclitaxel associated or not with EPO.~   "
232155|NCT00517608|"~     Monopolar electro surgery scissors (MES), electro thermal bipolar vessel sealer (BVS) and~     ultrasonically coagulating shears (UCS) are all applied in laparoscopic colorectal surgery.~     We aimed to compare the different devices with regard to dissection time, blood loss,~     technical aspects and costs.~        -  Trial with surgical intervention~   "
232156|NCT00517595|"~     The primary objective is to determine the progression free survival with pemetrexed, and~     gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage~     IIIB/IV non-small cell lung cancer (NSCLC).~      The secondary objectives are to determine the overall response rate; overall survival;~     chemotherapy induced toxicity profile of this combination; time to progression; and patient~     reported symptom burden.~   "
232157|NCT00517582|"~     Individuals with heart disease or high blood pressure are often prescribed angiotensin~     converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors~     can be associated with angioedema, a rare but life-threatening condition that causes swelling~     of the face and other body parts. This study will evaluate the effectiveness of the drug~     HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the~     condition.~   "
232158|NCT00517569|"~     The purpose of this study is to assess the safety of GX-12 gene therapy combined with HAART~     in the HIV-1 infected patients and to investigate the efficacy with the value of plasma viral~     load and with CD4 counts and HIV-1 specific IFN-gamma expressed T-lymphocytes~   "
232159|NCT00517556|"~     The primary hypothesis is that continuous administration of an OCP (CCOCP regimen) will~     result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea~     (PD) patients.~   "
232160|NCT00517543|"~     This study is being conducted to measure the amount of study drug that is in your blood after~     you receive a different type of tablet in each of four study visits.~   "
232180|NCT00517283|"~     As exenatide slows the rate at which materials leave the stomach, it is likely to alter the~     rate of intestinal absorption of oral drugs when administered within a certain timeframe~     relative to exenatide. In addition, the residence time within the stomach of other medication~     may be prolonged and data from this study will help assess the change in residence time in~     the presence of therapeutic doses of exenatide. This study will also evaluate the~     relationship between blood levels of exenatide and parameters measuring rate of stomach~     emptying.~   "
232161|NCT00517530|"~     The primary objective for the phase I part of the study is to investigate the safety and~     tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in~     participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell~     chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective~     for the phase II part of the study is to investigate the efficacy and safety of one dose of~     obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either~     indolent (iNHL) or aggressive (aNHL).~      It is an open label dose escalating study in phase I and open label in phase II, but the two~     doses in iNHL & aNHL are randomized (to high or low dose of the same open label treatment).~     CLL was not randomized as only one dose level was used.~      Participants with a response who might gain additional benefit from being treated again in~     the opinion of the investigator may be enrolled in a Retreatment Period.~   "
232162|NCT00517517|"~     The objectives of this Phase I/II study are to assess the safety and immunogenicity of two~     different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult~     population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days~     apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in~     a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response~     to the vaccine. A data safety monitoring board will review the safety data after the first~     and second vaccination.~   "
232163|NCT00517504|"~     The purpose of this study is to determine if methylphenidate (a common brand name is~     Ritalin), a medicine used for treating older children with Attention Deficit and~     Hyperactivity Disorder (ADHD), is also safe and helpful for problems related to symptoms of~     ADHD in young children with Developmental Disorders (DD)~   "
232164|NCT00517491|"~     The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels~     and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical~     improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)~   "
232165|NCT00517478|"~     Determine usefulness of thromboelastography (TEG) as a valuable tool in ex-vivo assessing~     platelet response to aspirin and clopidogrel (dual) treatment and on-treatment platelet~     reactivity during acute ST segment elevation myocardial infarction (STEMI) in an acute phase~     during primary PCI (PPCI) and also during recovery been on maintenance medical therapy and to~     determine the correlation between platelet response to clopidogrel treatment and the outcome~     of patients.~   "
232166|NCT00517465|"~     This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and~     tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2~     diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose~     will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid~     for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability,~     pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study~     treatment is <3 months, and the target sample size is <100 individuals.~   "
232167|NCT00517452|"~     The use of platelet rich plasma will decrease wound infection postop.~   "
232168|NCT00517439|"~     This 7 arm study will determine the optimal treatment combination, based on efficacy and~     safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7~     treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV~     polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or~     180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24~     weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus~     1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus~     PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks,~     those achieving a rapid virological response (RVR) will stop all medication, and non-RVR~     patients will remain on triple combination for an additional 24 weeks. Group 7 will receive~     standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free~     follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months,~     and the target sample size is 100-500 individuals.~   "
232169|NCT00517426|"~     To evaluate the effects of CO2 inhalation and acetazolamide treatment on exercise-induced~     periodic breathing in patients with chronic stable heart failure.~      Patients will be given CO2 (2%) during a constant workload exercise. Patients will be also~     evaluated by maximal cardiopulmonary exercise test without and with acetazolamide acute and~     chronic treatment.~   "
232170|NCT00517413|"~     This single arm study will assess the efficacy and safety of Mircera when administered once~     monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in~     dialysis patients with chronic renal anemia. Patients currently receiving maintenance~     treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose~     (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the~     week preceding study start. The anticipated time on study treatment is 3-12 months, and the~     target sample size is 100-500 individuals.~   "
232171|NCT00517400|"~     Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic~     stress disorder (PTSD).~      Comparing real to sham treatment.~   "
232172|NCT00517387|"~     Recently published work has examined the effects of atypical antipsychotics in~     SSRI-treatment resistant patients. In these studies, patients with unipolar depression who~     were treated with SSRI's, but not responsive to treatment after 4 or more weeks, were~     supplemented with an atypical. The atypical antipsychotics were found to diminish depression~     symptoms, as well as benefit sleep quality.~      We propose a similar study with Quetiapine XR, focusing on thinking processes, mood and~     anxiety. Patients with depression who are SSRI treatment resistant will be treated with~     Quetiapine. Cognition will be evaluated in the UBC Mood Disorders Clinic two times: first~     before Quetiapine addition, then after 8 weeks. Depression symptoms and other measurements~     will be done at the 9 time points: before Quetiapine, and each week after treatment has~     begun.~      The primary purpose of this study is to evaluate the superiority of Quetiapine XR compared to~     placebo as augmentation therapy in treatment of anxiety and depressive symptoms in~     SSRI-nonresponsive unipolar patients. Secondarily, we would like to evaluate the safety and~     tolerability of quetiapine as augmentation therapy in SSRI-nonresponsive unipolar patients.~   "
247385|NCT00314951|"~     This is a comparative study to investigate the safety and efficacy of fidaxomicin versus~     vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).~   "
232181|NCT00517270|"~     Non-cardiac chest pain accounts for 2-5% of all emergency presentations. In the United~     States, it has been estimated approximately that US$8 billion was spent annually for the~     initial care of patients suspected to have an acute coronary syndrome, but who were~     subsequently found not to have coronary artery disease (1). The most common cause of~     non-cardiac chest pain is gastro-oesophageal reflux disease (2). Two randomized,~     double-blind, placebo-controlled trials on the use of omeprazole versus placebo for the~     treatment of NCCP have been published in the western population and reported an efficacy of~     62% to 80% (3,4). High-dose omeprazole was used in the previous trials (3,4). Recently, it~     has been shown that rabeprazole, which is a newly developed benzimidazole proton pump~     inhibitor, is a more potent and rapid inhibitor of H+,K+-ATPase and acid secretion than~     omeprazole, lansoprazole and pantoprazole (5,6). Whether the above findings applied to~     Chinese population is unknown. Thus we would like to propose a randomized double-blind~     placebo-controlled trial to study the effects of high-dose proton pump inhibitor for the~     treatment of non-cardiac chest pain in Chinese population. The aim of this study is to~     evaluate the efficacy of high-dose proton pump inhibitor for the treatment of~     gastro-oesophageal reflux related non-cardiac chest pain.~   "
232182|NCT00517257|"~     The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision,~     when compared to placebo~   "
232183|NCT00517244|"~     This study will look at similarities and differences in family processes and child~     temperament among children with and without symptoms of anxiety disorders.~   "
232184|NCT00517231|"~     Tuberculosis is a highly prevalent chronic infectious disease caused by Mycobacterium~     tuberculosis. Cytokines are important biological mediators that regulate immune and~     inflammatory responses against the bacilli, witch include the acute phase response. Besides~     this, it becomes essential to determine markers of healing lesions, once this is currently~     carried out based on the clinical, radiological, and negative bacterioscopy.~   "
232185|NCT00517218|"~     To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and~     rituximab versus combination treatment with fludarabine and rituximab in previously untreated~     subjects with CLL.~   "
232186|NCT00517205|"~     The purpose of this research is to assess the role of non-contrast helical computerized~     tomogram in predicting the treatment outcome of upper ureteric stone by extracorporeal shock~     wave lithotripsy (ESWL).~   "
232187|NCT00517192|"~     The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir~     (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600~     mg /100 mg twice daily) in combination with investigator selected optimised background~     regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI),~     Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI))~     treatment-experienced (a minimum of 3-months duration for each class) with resistance to more~     than one PI on the screening virtual phenotype resistance testing.~   "
232188|NCT00517179|"~     The purpose of this study is to investigate the interaction between doxazosin GITS and~     vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with~     both ED and BPH.~   "
232189|NCT00517166|"~     Data will be collected on the type of tourniquet and circumstances of its use. Patients with~     penetrating extremity injury will have clinical and pre-clinical hospital data collected.~   "
232190|NCT00517153|"~     This is a phase II randomized controlled study of miglustat in adult and juvenile patients~     with Niemann-Pick Type C disease. Up to 42 patients will be randomised in a 2:1 ratio to~     either treatment with miglustat or to a non-treatment group. Both groups will follow an~     identical visit schedule.~   "
232191|NCT00517140|"~     The incidence of caesarean section has reached 15-20% in most developed countries.~     Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component~     of a strategy to reduce the caesarean section rate. Most medical literature has focused on~     the efficacy of VBAC in reducing the caesarean section rate and the physical safety of~     successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little~     is known about how the uncertainty of labour outcome and a failed VBAC impact on the~     psychosocial function of these women. We propose to study a cohort of women with a prior~     caesarean section and presenting with a subsequent pregnancy for care. After consent and~     recruitment, these subjects will be randomly assigned to have a repeat caesarean section or~     VBAC. The medical outcomes, overall satisfaction of the subjects with the care they received,~     and the short-term psychosocial function of these subjects will be studied. The result of~     this study will provide important information that would be useful in assisting women to~     decide the mode of delivery after a prior caesarean section.~   "
232192|NCT00517127|"~     The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid~     management leads to less perioperative morbidity compared to crystalloid-based goal-directed~     intraoperative fluid management. Goal-directed therapy is based on measurements by an~     Esophageal Doppler Device.~   "
232193|NCT00517114|"~     The purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo~     in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of~     Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. A~     questionnaire will be administered by the research assistant of the Department of Medicine~     and ENT, Queen Mary hospital. A 12-week course of PPI versus placebo trial will be commenced~     and patients' symptoms and signs will be documented at 6-week and 12-week time. The study~     will finish after a 12-week course of rabeprazole.~   "
232194|NCT00517101|"~     A relationship between IBD and spondyloarthropathy is well recognized. ASCA ( anti~     saccharomyces cerevisiae antibodies)are considered to be a serological marker for Crohn's~     disease and have been studied in patients with spondyloarthropathy with conflicting results.~     More recently, new serological markers for IBD have been described. These markers are~     antibodies to certain defined glycans , and their use may permit an improved diagnosis of~     IBD.~      The aim of our study is to investigate wether these new serological markers are present in~     the sera of patients with spondyloarthropathy.~   "
232195|NCT00517088|"~     Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had~     already been treated at the Ambulatory of Botucatu School of Medicine were selected. The~     measuring tool used for the level of physical activities was the International Physical~     Activities Questionnaire (IPAQ-short version), validated by the World Health Organization -~     Physical Activities and Health International Committee (1998).~   "
232196|NCT00517075|"~     This study will test whether repetitive transcranial magnetic stimulation (rTMS) is helpful~     in treating negative symptoms and social deficits of schizophrenia. This will be the first~     rTMS study to assess social function and social cognition.~        1. Hypoactivity in the dorsolateral prefrontal cortex (DLPFC) has been implicated in~          generating the negative symptoms of schizophrenia. Abnormalities in the left inferior~          parietal lobe (IPL) have also been associated with negative symptoms. We hypothesize~          that high frequency rTMS applied to the hypoactive left DLPFC or to the left IPL in~          individuals with schizophrenia will reduce negative symptom severity more than sham~          (placebo) rTMS as assessed by the Positive and Negative Syndrome Scale (PANSS) negative~          symptoms subscale.~        2. We hypothesize that high frequency rTMS applied to the left DLPFC or to the left IPL in~          schizophrenia patients will improve social dysfunction more than sham (placebo) rTMS as~          assessed by the Social Adjustment Scale, the Social Adaptation Self-Evaluation Scale and~          the Social Functioning Scale.~   "
232197|NCT00517062|"~     Study hypothesis:~      Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor~     (IGF)-I, can improve insulin sensitivity in adults with GH deficiency.~      Study aims:~      The purpose of this study is to determine the mechanism of how low dose GH treatment affects~     the body's sensitivity to insulin actions and whether this low GH dose can affect the body's~     handling of steroid hormone levels (cortisol clearance) in adults with GH deficiency.~      Study design:~      Men and women with confirmed GH deficiency, but not recently been on GH treatment will be~     invited to participate in this study. The subjects will be assessed at the initial visit to~     ascertain their suitability before further participating in the study. If suitable, an equal~     number of men and women will be randomized to receive either low dose GH or placebo injection~     for 3 months. Before, during and after treatment, the subjects will be assessed at regularly~     with blood tests, scans and fat biopsies. At the first and final visit, testing will include~     scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver;~     blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to~     measure the density of IGF-I in the muscle; whereas blood tests to examine insulin~     sensitivity will also be collected. This study will use Genotropin and Genotropin pen~     devices, and the the data will be analyzed using a computer statistical program where the~     identity of the subjects will be coded to maintain confidentiality.~   "
232198|NCT00517049|"~     This Phase II, single-arm, open-label, multicenter trial is designed to evaluate the safety,~     efficacy, and pharmacokinetics of PRO95780 when combined with rituximab in patients with~     follicular, CD20-positive B-cell NHL that has progressed following previous rituximab~     therapy.~   "
232199|NCT00517036|"~     This study will test the effectiveness of two different kinds of omega-3 fatty acid dietary~     supplements in treating the symptoms of major depression.~   "
232200|NCT00517023|"~     Syncope (commonly called collapses or blackouts) is defined as loss of consciousness which is~     transient, self limiting and usually leads to falling.~      While the causes of syncope encompass a wide variety of factors, those due to heart rhythm~     abnormalities are acknowledged to be significantly more serious compared with other causes.~      The main aim of the study is to see if it is possible to find the cause of a patient's~     syncope faster using a device called an implantable loop recorder (ILR), which is implanted~     under the skin, versus conventional management. The device is slightly larger than a 50 pence~     coin and records the rhythm of the heart continuously.~      Although ILRs are being used widely today, we want to use a new model that is able to relay~     information to the doctor via wireless technology and internet.~      We also want to use ILRs earlier in diagnosing syncope, thereby avoiding unnecessary and~     lengthy hospital admissions and lowering cost.~      Primary aim: To see how soon the ILR detects abnormal heart rhythms or normal ones (in study~     subjects who faint/ suffer syncope).~      Secondary aims are:~        1. To see how soon treatment is started once the abnormal rhythm is detected by the ILR.~        2. To see which group (patients with ILRs or those receiving conventional tests) receives~          treatment sooner.~        3. To see which group has less subsequent collapses i.e has benefited from appropriate~          treatment sooner.~        4. To assess the cost effectiveness of using the implantable loop recorder more as a~          diagnostic tool for syncope versus conventional management (it should save many hospital~          admissions).~   "
232201|NCT00517010|"~     Because a possible synergism of radiation and inhibitors of vascular endothelial growth~     factor has been shown in cancer patients and patients with wet macular degeneration, this~     pilot study is being conducted to determine whether treating wet macular degeneration with a~     combination of Lucentis and proton beam irradiation is safe. Lucentis is an inhibitor of~     vascular endothelial growth factor which was recently FDA approved for treatment of wet~     macular degeneration. It appears to be the most effective therapy thus far for wet macular~     degeneration among all drugs FDA approved for this condition. If no major safety issues are~     associated with this combination therapy, a larger study will be conducted to determine~     whether this combination therapy is more effective than Lucentis monotherapy.~   "
232202|NCT00516984|"~     The relationship between Osteopathic Manipulative Therapy (OMT) and the autonomic nervous~     system is poorly understood. This study quantifies that relationship and demonstrates a cause~     and effect. It is hypothesized that cervical myofascial release increases vagal tone.~   "
232203|NCT00516971|"~     The purpose of this study is to evaluate the efficacy of proton pump inhibitor for the~     treatment of non-erosive reflux disease (NERD) in Chinese population. Studies from the~     western population have estimated a worldwide prevalence of gastro-oesophageal reflux disease~     from 10 to 20 %. Monthly symptoms of heartburn or acid regurgitation were found in 9.3% of~     subjects according to a population survey in Hong Kong. Most of these patients did not show~     evidence of erosive change during upper endoscopy. However, patients with NERD suffer from~     similar impairment of quality of life as patients with erosive oesophagitis and their~     symptoms are as severe as patients with erosive disease. Data on the use of proton pump~     inhibitor for the treatment of NERD in Chinese patients are scanty. Thus we want to perform a~     double-blind randomised placebo-controlled study to evaluate the efficacy of proton pump~     inhibitor for the treatment of NERD in Chinese population.~   "
232204|NCT00516958|"~     To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs.~     Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.~   "
232205|NCT00516945|"~     Patients with non-lymphoma and non-leukaemia cancer who are also hepatitis B carriers will~     have a risk of hepatitis B reactivation during chemotherapy. Lamivudine can be used~     effectively to control hepatitis upon reactivation during chemotherapy and the chemotherapy~     may not need to be interrupted. The study aims to investigate whether adding the anti-viral~     drug Lamivudine at the start of chemotherapy for all patients, rather than at the time of~     hepatitis reactivation for those with reactivation, will help to improve the delivery of~     chemotherapy in these patients.~   "
232206|NCT00516932|"~     This study will identify variations in genes that may be involved in the development of~     suicidal events or certain behaviors in youth who are exposed to antidepressant medications.~   "
232207|NCT00516919|"~     This is a research study designed to examine the effectiveness of an obesity medication~     (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese~     monolingual (Spanish-speaking only) men and women.~   "
232208|NCT00516906|"~     Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV~     Dressing~   "
232209|NCT00516893|"~     The primary objective of the study was to evaluate the immunogenicity of natalizumab~     (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E)~     administered intravenously (IV) to participants with relapsing forms of multiple sclerosis~     (MS). The secondary objective of this study was to evaluate the safety of natalizumab high~     titer.~   "
232210|NCT00516880|"~     Peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality~     and are related to the presence of accelerated atherosclerosis. Our recent data showed that~     inflammation predicts mortality and cardiovascular death, independent of other cardiovascular~     risk factors in peritoneal dialysis patients. As a considerable proportion of peritoneal~     dialysis patients showed evidence of inflammation, it raises an important question as to~     whether anti-inflammatory treatment has any cardiovascular and survival benefit in these~     patients. The peroxisome proliferator-activated receptor-gamma (PPAR-g) agonist is a class of~     drug with insulin sensitizing property. Recent experimental and clinical studies demonstrated~     that this class of drug has anti-inflammatory and anti-atherosclerotic properties other than~     insulin sensitizing effect in type 2 diabetics. We therefore hypothesize that modulation of~     the PPAR-g activity may be a novel therapeutic strategy for reducing inflammation and~     retarding the progression of atherosclerosis and possibly lowering mortality in our~     peritoneal dialysis patients.~   "
232211|NCT00516867|"~     We would investigate in a controlled, randomized open study in the winter season: 1) If serum~     levels of vitamin D (25(OH)D) increase in subjects treated with sunbed with sunlamps emitting~     mainly UVA and only 0·5% or 1·4% UVB compared to non-sunbed treated controls 2) If yes, are~     the 25(OH)D serum levels then dependent on the UVB dose?~   "
232212|NCT00516854|"~     Non-cardiac chest pain is a common clinical problem encountered in our practice but at~     present, the results of treatments are unsatisfactory. The pathogenesis remains unknown but~     altered motility of the esophagus and psychological factors including anxiety have been~     implicated as important factors. Reports of the single use of anticholinergic drugs and~     anxiolytics have yielded conflicting results, has been demonstrated to yield marginal or of~     no value. However the use of the combination therapy, especially with a double blind fashion~     have not been reported. On that basis, we propose to use a combination of anti-cholinergic~     and tranquilliser for the symptomatic treatment of non-cardiac chest pain. The aim of this~     study is to evaluate the efficacy of combination therapy of anti-cholinergic and anxiolytic~     drugs in the treatment of non-cardiac chest pain.~   "
232213|NCT00516841|"~     To evaluate the efficacy of voloxicimab when administered at 15 mg/kg qwk in subjects with~     platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.~   "
232214|NCT00516828|"~     RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth or by blocking blood flow to the cancer. Drugs used in chemotherapy,~     such as cytarabine, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving sorafenib together with~     cytarabine may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib~     together with cytarabine and to see how well it works in treating older patients with acute~     myeloid leukemia or high-risk myelodysplastic syndrome.~   "
232215|NCT00516802|"~     This is a Phase I, open-label, dose-escalating, study of the safety and tolerability of~     KU-0059436 in combination with DTIC in the treatment of patients with advanced melanoma who~     have not previously received systemic cytotoxic chemotherapy.~   "
232216|NCT00516776|"~     The study includes individuals with ulcerative colitis, Crohn's disease and healthy controls.~     The purpose of this study is to examine the innate immune system (IIS) by exposing peripheral~     blood monocytes to various ligands relevant for stimulation of the IIS and study the immune~     response. Colonic mucosal samples are examined to find gene expression patterns which may~     distinguish the two forms of disease from each other and from healthy controls.~      The hypothesis is that the innate immune system has responses unique for the disease states,~     and that the diseases may be differentiated by examination of gene expression patterns in~     mucosal biopsies.~   "
232217|NCT00516750|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin, and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells. Evaluating blood or tissue samples from patients with cancer may~     help doctors learn more about changes that occur in DNA, identify biomarkers related to~     cancer, and predict how well patients will respond to combination chemotherapy.~      PURPOSE: This phase II trial is studying gene expression profiling to see how well it works~     in predicting response to treatment in patients with invasive bladder cancer receiving~     methotrexate, vinblastine, doxorubicin, and cisplatin.~   "
232218|NCT00516737|"~     The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early~     treatment of an acute migraine attack.~   "
232219|NCT00516724|"~     The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436~     that can be given in combination with carboplatin and/or Paclitaxel chemotherapy~   "
232239|NCT00516438|"~     The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436~     that can be given in combination with topotecan chemotherapy in patients with advanced solid~     tumours~   "
232221|NCT00516698|"~     RATIONALE: Studying changes in breast density and blood hormone levels in women receiving~     anastrozole or exemestane for breast cancer may help doctors learn more about the long-term~     effects of treatment and may help the study of breast cancer in the future.~      PURPOSE: This clinical trial is studying changes in breast density and blood hormone levels~     in postmenopausal women receiving anastrozole or exemestane for breast cancer.~   "
232222|NCT00516685|"~     The purpose of this study is to determine whether the recombinant human EGF-rP64K/Montanide~     ISA 51 vaccine is safe, immunogenic and effective in the treatment of stage IIIb/IV~     non-small-cell lung cancer (NSCLC).~   "
232223|NCT00516672|"~     This is a two part phase I study in Japanese patients that will determine the safety,~     tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination~     with lapatinib.~   "
232224|NCT00516659|"~     This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate~     the epidemiology of natural infection with ETEC occurring after transcutaneous immunization~     in a field setting.~   "
232225|NCT00516646|"~     Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a~     role in the development and progression of heart failure. The AGE-crosslink breaker~     Alagebrium (ALT-711) improved cardiac function and symptoms in experimental and small human~     heart failure studies. These results have not yet been confirmed in a randomized controlled~     clinical trial.~   "
232226|NCT00516633|"~     We wanted to investigate if it was possible to improve adherence to prescriptions and advice~     in pre-school children with newly diagnosed asthma. The intervention was intense information~     and support in the form of four group discussions with the parents of four children in close~     connection to diagnosing the child. The control children received the usual care with~     individual polyclinic visits to the physi-cian/nurse. We evaluated the effect with the help~     of questionnaires, physical examinations, blood tests, lung function tests and control of~     treatment adherence after 18 months and 6 years.~   "
232227|NCT00516620|"~     The aim of this study is to see if the investigators can encourage people to eat more fruits,~     vegetables and whole grains and drink less pop by giving them advice about their diet, or by~     providing them with samples of different kinds of foods. The investigators are interested in~     the effect this has on reducing the risk of chronic disease. The investigators will also be~     investigating how certain genes affect the choices people make about the foods they eat.~   "
232228|NCT00516607|"~     RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as temozolomide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving enzastaurin together with~     temozolomide may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin when~     given together with temozolomide in treating patients with primary gliomas.~   "
232229|NCT00516594|"~     Our antibiotic studies indicated that cholesterol lowering was seen when fecal~     bifidobacterial counts were increased. Due to the dangers associated with prolonged~     antibiotic use we have been funded by the Heart and Stroke Foundation to see if gut bacteria~     can be modified by non-antibiotic means. Inulin a dietary fiber found in artichokes, chicory,~     leaks, onion, etc., (which also produces flatulence) has been shown to increase~     bifidobacteria and also appears to lower serum cholesterol. We will therefore test the fiber~     to determine its effectiveness in lowering serum cholesterol and whether it can be used to~     maximize the cholesterol-lowering effects of soy protein foods and viscous fiber foods (e.g.~     oats and psyllium).~   "
232230|NCT00516581|"~     From the beginning of the AIDS epidemic, pulmonary pneumocystosis (PCP) has been~     distinguished as one of the most frequent opportunistic diseases with high morbid-mortality.~     As from 1996, the advent of the highly active antiretroviral therapy (HAART) has changed the~     characteristics of such epidemic by reducing its related diseases and, as a result,~     AIDS-related mortality. With the purpose to estimate PCP occurrence and HAART interference,~     376 HIV-infected or AIDS patients were studied from January 1992 to December 2002.~   "
232231|NCT00516555|"~     The purpose of this study is to evaluate whether successful external cephalic version is~     associated with maternal thyroid function and mood state in pregnant women with breech~     presentation at term.~      The relationship between successful external cephalic version and neonatal thyroid function~     will also be investigated.~      A possible beneficial effect of successful external cephalic version on the development of~     congenital hip dysplasia will be evaluated.~   "
232232|NCT00516542|"~     RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using~     dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the~     tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA~     together with letrozole may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given~     together with letrozole in treating patients with metastatic breast cancer.~   "
232233|NCT00516516|"~     Muscle cramps occur frequently among pregnant women, and few therapeutic options exist. This~     is a study of oral L-carnitine, a dietary supplement, for the treatment of muscle cramps in~     pregnancy. Our hypothesis is that carnitine will alleviate or eliminate muscle cramps~     experienced by pregnant women.~   "
232234|NCT00516503|"~     RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused~     by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in~     treating peripheral neuropathy caused by chemotherapy .~      PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works~     compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients~     with cancer.~   "
232235|NCT00516490|"~     A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles~     was reported to increase pregnancy and birth rates. This study was done to evaluate the~     reproducibility of previous findings.~   "
232236|NCT00516477|"~     The purpose of this study is to determine whether gene transfer will be safe and effective in~     the treatment of Leber Congenital Amaurosis (LCA).~   "
232237|NCT00516464|"~     Evaluation of ranibizumab on the ease and procedure and complication in proliferative~     diabetic retinopathy (PDR) requiring vitrectomy.~   "
232238|NCT00516451|"~     The purpose of this clinical study is to identify the maximum tolerated dose (MTD) of~     BMS-690514 once daily orally in Japanese subjects with advanced or metastatic solid tumors.~   "
232240|NCT00516425|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, epirubicin, and cyclophosphamide,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor~     cells that remain after surgery. Sometimes, after surgery, the tumor may not need more~     treatment until it progresses. In this case, observation may be sufficient. It is not yet~     known whether giving doxorubicin or epirubicin together with cyclophosphamide is more~     effective than observation in treating older women with invasive breast cancer.~      PURPOSE: This randomized phase III trial is studying doxorubicin or epirubicin and~     cyclophosphamide to see how well they work compared with observation in treating older women~     with invasive breast cancer.~   "
232241|NCT00516412|"~     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with~     relapsed or refractory mantle cell lymphoma.~   "
232242|NCT00516399|"~     The purpose of this study is to determine the effectiveness of 1.25% povidone-iodine~     ophthalmic solution for the treatment of small to medium sized fungal corneal ulcers compared~     with an antifungal antibiotic.~   "
232243|NCT00516386|"~     The purpose of this study was to determine whether giving insulin like growth factor-I~     (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone~     formation markers.~   "
232244|NCT00516373|"~     To determine the safety, tolerability, dose-limiting toxicity (DLT),~     pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when~     administered orally to patients with advanced solid tumours. To further evaluate the safety~     and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily~     ovarian cancer patients.~   "
232245|NCT00516360|"~     The purpose of this study is to prevent catheter-related infections in newborn infants~     admitted to the Neonatal Intensive Care Unit (NICU). This study will compare the~     effectiveness of daily chlorhexidine versus isopropyl alcohol in preventing the growth of~     microbes in catheters.~   "
232246|NCT00516347|"~     RATIONALE: Learning about how often heartburn and other risk factors occur in brothers and~     sisters and other family members of patients with Barrett's esophagus may help identify other~     individuals at risk and identify genes for Barrett's esophagus.~      PURPOSE: This clinical trial is studying genes for Barrett's esophagus in brothers and~     sisters.~   "
232247|NCT00516334|"~     This study is evaluating whether a bedside brainwave monitor can be used to detect early~     brain injury in premature infants.~   "
232248|NCT00516321|"~     The purpose of this study is to assess the ability of eltrombopag to maintain a platelet~     count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy~     dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical~     benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve~     a Sustained Virological Response (SVR).~   "
232249|NCT00516308|"~     To assess the proximity of the catheter to the vessel wall and to correlate excised tissue~     with images collected by the integrated Optical coherence Tomography (OCT) imaging system.~     The primary endpoints are correlation between OCT images and histological characterization of~     excised tissue.~   "
232250|NCT00516295|"~     This phase II trial study has a 6-patient feasibility portion studying the tolerability of~     chemotherapy with vincristine sulfate together with topotecan hydrochloride,~     cyclophosphamide, and bevacizumab in treating young patients with refractory or first~     recurrent extracranial Ewing's sarcoma. If the therapy is considered tolerable, this~     feasibility run-in will be followed by a randomized phase II portion studying giving~     vincristine sulfate together with topotecan hydrochloride, and cyclophosphamide to see how~     well it works compared with giving vincristine sulfate together with topotecan hydrochloride,~     cyclophosphamide, and bevacizumab in treating young patients with refractory or first~     recurrent extracranial Ewing's sarcoma. Drugs used in chemotherapy, such as vincristine~     sulfate, topotecan hydrochloride, and cyclophosphamide, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop tumor growth by~     blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab~     may kill more tumor cells.~   "
232251|NCT00516282|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Temozolomide may also stop the growth of tumor cells by blocking blood flow to the~     tumor.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M when~     given together with temozolomide and to see how well it works in treating patients with~     progressive or relapsed malignant glioma.~   "
232252|NCT00516269|"~     The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl~     (Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma,~     myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have~     completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug~     will also be studied. Another goal of the study is to see how certain cytokines change while~     patients undergo chemotherapy or hormonal treatment.~   "
232253|NCT00516256|"~     The aims include:~        1. To measure the effect of the three study conditions on Quality of Life (QOL).~             -  CHESS and Cancer Information Mentor will not differ initially (6 weeks) or late in~               treatment (6 months) in QOL~             -  CHESS +Cancer Information Mentor will have the largest impact on QOL (initially and~               late in treatment) and will be significantly better than either CHESS or Cancer~               Information Mentor alone.~        2. To measure potential intervening or mediating processes, so that we can determine how~          CHESS and the Cancer Information Mentor produce associated QOL benefits.~        3. To conduct exploratory use analyses examining which types of CHESS content, sequential~          patterns of content use, or other characteristics of use behavior are associated with~          greater pretest-posttest improvements in QOL.~        4. To conduct a secondary analysis exploring whether men whose partners have actively used~          CHESS do better than those whose partners did not use CHESS.~   "
232256|NCT00516217|"~     RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them.~      PURPOSE: This phase II trial is studying how well galiximab works in treating patients with~     relapsed or refractory Hodgkin's lymphoma.~   "
232257|NCT00516204|"~     A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus~     coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and~     rate of patients who are treated to target (which is <70mg/dl for such patients with very~     high risk) are screened. The doctors therapy decisions after the screening will be documented~     and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to~     evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and~     to underline the importance of treating patients to their cholesterol targets.~   "
232258|NCT00516191|"~     The primary objective of this study is to evaluate the safety and tolerability of four dose~     levels of liposomal doxorubicin, melphalan, and bortezomib in patients with~     relapsed/refractory MM and to identify a maximum tolerated dose (MTD) of this combination.~   "
232259|NCT00516178|"~     A large body of evidence has accumulated showing that n-3 PUFAs exert extensive cardiac~     effects. The development of commercial solutions of FO opens perspectives for therapeutic~     applications in patients with acute cardiac conditions.the 3 following hypotheses will be~     addressed in patients requiring cardiac surgery under cardiopulmonary bypass or after~     myocardial infarction:perioperative /post-PTCA intravenous fish oil modifies the composition~     of membrane phospholipids in platelets and cardiac cells, blunts the physiological response~     to cardiac surgery/myocardial infarction, and reduces the incidence of arrhythmias, and~     reduces the occurrence of systolic dysfunction.~   "
232260|NCT00516165|"~     Laboratory studies have shown that RAD001 can prevent cells from multiplying. Consequently,~     the study drug is being tested in medical conditions in which excessive cell multiplication~     (as in cancer) needs to be stopped. The main purpose of this research study is to find the~     highest dose of RAD001 that can be given safely (without causing severe side effects) and to~     learn the effects (good or bad) RAD001 has on participants with liver cancer.~   "
232261|NCT00516152|"~     The primary objective of this study is to assess the safety and efficacy of performing~     unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative~     therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to~     demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40%~     at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to~     demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.~   "
232262|NCT00516139|"~     This study is being conducted to determine the safety and tolerability of lamotrigine (LTG)~     in elderly patients with epilepsy. This study will be carried out using an extended-release~     formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.~   "
232263|NCT00516126|"~     Aim of this study is to investigate whether patients preoperatively treated with~     acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts~     of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE~     (thrombocyte function analyzer).~   "
232264|NCT00516113|"~     The objective of this study is to explore the onset of action when serotonin reuptake~     inhibitors are used to treat premenstrual dysphoric disorder~   "
232265|NCT00516100|"~     Pemetrexed is an FDA-approved treatment for advanced lung cancer but the response rate is~     still very low. Bortezomib is currently approved to treat myeloma in patients who have~     already been treated. Currently, multiple studies are actively investigating how well~     bortezomib works with other drugs. This study is testing how much bortezomib can be given to~     advanced lung cancer patients who have already received one treatment. This study will also~     see how well bortezomib and pemetrexed work together to treat lung cancer patients.~   "
232266|NCT00516087|"~     Patients have a type of cancer called nasopharyngeal carcinoma (NPC) which has either come~     back, not gone away or is at high risk for coming back after the best treatment we know for~     this disease. We are inviting patients to participate in a research study using a new~     experimental therapy consisting of special immune system cells called LMP1- and LMP2-specific~     cytotoxic T lymphocytes (LMP1- and LMP2-CTLs).~      Some patients with nasopharyngeal carcinoma show evidence of infection with the virus that~     causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their~     diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage NPC,~     suggesting that it may play a role in causing the disease. The cancer cells infected by EBV~     are able to hide from the body's immune system and escape destruction. We want to see if~     special white blood cells, called T cells, that have been trained to recognize and kill~     special parts of EBV infected cells can survive in blood and affect the tumor.~      We have used this sort of therapy to treat a different type of cancer that occurs after bone~     marrow and solid organ transplant called post-transplant lymphoma. In this type of cancer the~     tumor cells have 9 proteins made by EBV on their surface. We grew T cells in the laboratory~     that recognized all 9 proteins and were able to prevent and treat post-transplant lymphoma.~     However nasopharyngeal carcinoma tumor cells only express 2 EBV proteins (LMP1 and LMP2) on~     their surfaces. In a previous study we made T cells that recognized all 9 proteins and gave~     them to patients with NPC. While some patients had a response, only a few patients had their~     cancer completely go away. We are now trying to find out if we can improve this treatment by~     growing and giving T cells where more of the cells will recognize two of the proteins~     expressed on NPC cells called LMP1 and LMP2. These special T cells are called LMP1- and~     LMP2-CTLs. These LMP1- and LMP2-CTLs are an investigational product not approved by the Food~     and Drug Administration.~   "
232267|NCT00516074|"~     This study will explore the effect of exenatide (given twice a day) versus placebo (given~     twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug~     exposure in patients with type 2 diabetes.~   "
232268|NCT00516061|"~     Vascular endothelial growth factor(VEGF) appears to play a central role in the process~     leading to peritoneal angiogenesis and increased level of VEGF may contribute to high~     peritoneal small-solute transport rate (PSTR) in continuous ambulatory peritoneal dialysis~     (CAPD) patients in adult. In children, lymphatic absorption of solute is greater than adult.~     VEGF-C is related to lymphogenesis, but its role in peritoneal solute transport rate is not~     known. In this study, we evaluated possible relationship between dialysate VEGF and VEGF-C~     levels and PSTR in children.~   "
232269|NCT00516048|"~     The primary purpose of this study is to assess the anti-exenatide-antibody response to~     exenatide re-exposure as measured by anti-exenatide antibodies and incidence of~     treatment-emergent allergy and hypersensitivity reactions following a period of treatment~     interruption, in patients previously exposed to exenatide.~   "
232366|NCT00514761|"~     The purpose of the study is to assess if there is benefit when using AZD6244 in the treatment~     if metastatic colorectal cancer in comparison with another treatment called capecitabine.~     This study will also assess how safe and well tolerated AZD6244 is.~   "
232270|NCT00516035|"~     Over the past decade, avian influenza (AI) has become a major health concern. The development~     of safe and effective vaccines against avian strains infecting people is important. The~     purpose of this study is to determine the safety of and immune response to a new AI vaccine~     in healthy adults against the H7N3 strain of avian influenza.~   "
232271|NCT00516022|"~     Mistletoe extract is one of the most common complementary treatments used in Europe. Recent~     basic studies reported tumor response and survival prolongation in number of treatments with~     Mistletoe preparations. There are evidence based data for using this drug as side effect~     reducer when use in combination with chemotherapy regimen treatment. Other clinical data,~     although not well based is that complementary treatment when used in combination with the~     common oncology treatment has tumor response effect. Combinations with platinum compound and~     a third generation cytotoxic agent have been accepted as 'standard of care' for patients with~     advanced NSCLC. The combination of platinum compound and one of the new agents are associated~     with response rates of 30-40% and a median survival of 8-11 months for advanced NSCLC~     patients with good performance status.~      Study objective: Improvement in QOL, Improvement in the toxicity profile of the chemotherapy~     treatment.~   "
232272|NCT00516009|"~     Acute low back pain is one of the most common reasons for all physician visits(1).~     Phospholipase A2 (PLA2), a potent inflammatory mediator, has demonstrated to be released by~     discs following injury(4). Clinical practice and animal research suggest that lumbar~     radicular pain is the result of inflammation of the nerve root in the epidural space(5). The~     study will evaluate the efficacy of intravenous Dexamethasone for acute disc~     herniation-induced sciatica. 40 patients aged 18 years or older, who will be transferred to~     the emergency room due to sciatic pain will be blindly randomized to receive Dexamethasone 30~     mg IV for 3 days an tapering off, 10 mg daily, or normal saline. 20 patients will be in each~     group. The patients will continue their standard care during the study period. Follow up will~     last for 3 months. Mann-Whitney test will be used for parametric correlation, Wilcoxon for~     numeral and x² for categorial variables. Dexamethasone IV can help physicians in treating~     patients with acute sciatic pain.~   "
232273|NCT00515996|"~     We plan to examine genetic polymorphism of catechol-O-methyltransferase in panic disorder and~     neurobiological changes of panic disorder patients after 12 weeks of pharmacotherapy with~     paroxetine. We plan to include 40 panic disorder patients and 40 normal control subjects in~     this study for 3 years.~   "
232274|NCT00515983|"~     Background: Sixteen melanoma patients (1 stage IIC, 8 stage III, and 7 stage IV) were treated~     in a Phase I study to evaluate safety and immune responses, with a vaccine (DC/Apo-Nec)~     composed of autologous dendritic cells (DCs) loaded with a mixture of apoptotic/necrotic~     melanoma cell lines (Apo-Nec).~      Methods: PBMC were obtained from leukapheresis and DCs were generated from monocytes cultured~     in the presence of GM-CSF and IL-4 in serum-free medium. Immature DCs (iDCs) were loaded with~     gamma-irradiated Apo-Nec cells and injected id without adjuvant. Cohorts of four patients~     were given four vaccines with 5, 10, 15, or 20 x106 DC/Apo-Nec per vaccine, two weeks apart.~      Results: The vaccine was well tolerated in all patients. Toxicity to vaccine was mild, and~     the toxicity-limiting dose has not been reached. We found that 42.3 ±13.7 % melanoma~     patients´ iDCs were able to phagocyte Apo-Nec cells wich induced DCs maturation, as evidenced~     by increased expression of CD83, CD80, CD86, HLA class I and II compared to iDCs. Also, after~     phagocytosis, a 75.2 ±16 % reduction in Dextran-FITC endocytosis was observed compared to~     iDCs. CCR7 was upregulated upon Apo-Nec phagocytosis in DCs from all patients and accordingly~     in vitro DC/Apo-Nec cells were able to migrate towards MIP-3 beta. The DTH score increased~     significatively in the patients after the first vaccination and slightly decreased by the~     fourth vaccine (Mann-Whitney Test, p<0.05). For patient #1 a positive DTH reaction was~     detected to her own tumor irradiated cells. The presence of CD8+ T lymphocytes specific to~     gp100 and Melan A/MART-1 Ags were studied by tetramers binding in HLA-A*0201 patients (7 /15~     patients) before and after vaccination. Two patients who remain NED increased Ags their~     specific T lymphocytes after vaccination. No humoral responses to Apo-Nec cells were~     detected. With a mean follow-up of 44.5 months post-surgery, the stage IIC pt is NED, 7/8~     stage III pts are NED and 7/7 stage IV patients have progressed.~      Conclussions: We conclude that DC/Apo-Nec vaccine is well tolerated, it induces specific~     immunity against melanoma Ags and in stage III patients it may prolong disease-free survival,~     affording protection from relapse in an adjuvant setting.~   "
232275|NCT00515970|"~     Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys~     local anatomic structures. There are various treatment alternatives with different recurrence~     rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and~     the procedure is relatively expensive. Photodynamic therapy as well as imiquimod 5% are~     expensive therapies with high recurrence rates, that lack histologic evidence of BCC.~     Cryosurgery and curettage are inexpensive, although the recurrence rates are higher than~     after surgical excision.~      This prospective, randomized trial compares recurrence rates, cosmetic outcome, and~     surgery-related complications after curettage versus surgical excision in nodular and~     superficial BCC. About 600 tumors will be included. One half is treated by curettage, the~     other half by surgical excision. The follow-up period is four years. If the difference~     between recurrence rates is ≤7% and the cosmetic outcome as well as the surgery-related~     complications are not worse after curettage, surgical excision must be considered an~     overtreatment.~   "
232276|NCT00515957|"~     In this study NPC patient will receive 4 days of treatment with CD45 antibody followed by one~     dose of LMP1- and LMP2-CTL. From this, we can learn if treating the patient first with the~     CD45 antibody will also let LMP1- and LMP2-CTL we give grow better. In addition, we will find~     out, if LMP1- and LMP2-CTL are safe and have enhanced anti-tumor activity in comparison to~     standard EBV-CTL.~      This study aims to determine the safety of autologous LMP1- and LMP2- specific cytotoxic~     T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb) in patients with~     EBV-positive nasopharyngeal carcinoma (NPC).~      And to obtain information on the expansion, persistence and anti-tumor effects of autologous~     LMP1- and LMP-2 specific CTL given after lymphodepletion with CD45 MAb in patients with~     EBV-positive NPC.~   "
232277|NCT00515944|"~     Xeomin® is a Botulinum neurotoxin type A preparation free of complexing proteins, i.e. free~     of bacterial proteins other than the active toxin. Injected into the muscle, Xeomin® causes~     local weakening. Botulinum toxin type A is used for certain neurological and aesthetic~     treatments. This study will investigate the migration potential of Xeomin®.~   "
232278|NCT00515931|"~     Gastrointestinal stromal tumors (GISTs) are generally considered resistant to radiation, but~     no prospective trials addressing efficacy and tolerability of radiation therapy have been~     carried out. Limited clinical experience suggests that selected GIST patients may benefit~     from palliative radiation therapy. The purpose of this prospective, non-randomized,~     multicenter study is to evaluate efficacy and safety of palliative radiation therapy in GIST~     patients who have progressive GIST during or after tyrosine kinase inhibitor therapy.~   "
232279|NCT00515918|"~     The purpose of this project to examine brain functions and behavior related to ID including~     sensory ,motor, cognitive and social /emotional functioning, and address unanswered questions~     about brain and behavior impacts of different timing of ID(pre- and /or postnatal ID) in~     infants.~   "
232280|NCT00515905|"~     One-lung ventilation; organ protection; volatile anesthetics~      One-lung ventilation has become a common procedure for thoracoscopic surgery. Two hypothesis~     will be tested in this study:~        1. Are inflammatory mediators increased in the re-ventilated lung after short-period~          pulmonary collapse?~        2. Does Sevoflurane influence the production of inflammatory mediators in the re-inflated~          lung? Therefore, this study will elucidate the potential protective effect of a volatile~          anaesthetic (sevoflurane) on the production of inflammatory mediators by the respiratory~          compartment of the lung, i.e. the alveolar epithelium.~             -  Trial with immunomodulatory product / biological~   "
232281|NCT00515892|"~     RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal~     cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not~     responded to chemotherapy, surgery or radiation therapy.~      PURPOSE: Phase 1 dose escalation study to determine the maximum tolerated dose of CAT-8015~     immunotoxin in treating patients who have Non-Hodgkin's lymphoma and do not respond to~     treatment.~   "
232282|NCT00515879|"~     This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior~     therapy in treating people with social anxiety disorder.~   "
232283|NCT00515866|"~     The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436~     that can be given in combination with gemcitabine chemotherapy for the treatment of~     pancreatic cancer.~   "
232284|NCT00515853|"~     The purpose of this study is to determine whether biofeedback exercises improve anal~     continence after anterior resection for rectal cancer.~   "
232285|NCT00515840|"~     Breathing retraining supervised by a physiotherapist will result in improvements in the~     quality of life and asthma control of patients treated for asthma in the community with~     symptoms suggestive of dysfunctional breathing.~      To investigate the effects of breathing retraining on clinical and physiological parameters~     of asthma control, to identify the characteristics of patients who benefit, to perform a~     health economic evaluation.~   "
232286|NCT00515827|"~     Raltegravir (MK-0518) is an HIV-1 integrase inhibitor with potent in vitro activity against~     HIV-1 strains including those resistant to currently available antiretroviral drugs. The~     purpose of this study is to assess the effectiveness of raltegravir in further reducing viral~     load in HIV infected patients that have already achieved viral suppression below the level of~     detection of standard viral load assays when added to antiretroviral therapy (ART).~   "
232287|NCT00515814|"~     The outcome of this trial will reveal the possibilities of the retinal implant to improve the~     situation of patients with hereditary retinal blindness caused by degenerations of the outer~     retina. This pilot study will give important information on safety and efficacy of~     sub-retinal implants.~   "
232288|NCT00515801|"~     We aim to demonstrate that oral administration of glibenclamide stimulates pancreatic~     glucagon secretion during hypoglycemia in insulin-deficient (C-peptide negative) patients~     with type 1 diabetes when compared to type 1 diabetic patients with residual insulin~     secretion (C-peptide positive).~   "
232289|NCT00515788|"~     Objectives:~      - To determine the safety, tolerability and maximum tolerated dose (MTD) of oral temozolomide~     using a 7 days on and 7 days off regimen combined with intrathecal liposomal cytarabine~     (DepoCyt) in patients with neoplastic meningitis from solid tumors and systemic lymphoma.~   "
232290|NCT00515775|"~     The purpose of the study is to investigate, whether the FeNO concentration of asthmatic~     children is influenced differently by inhaled corticosteroid compared to inhaled~     corticosteroid + long acting beta agonist. The study hypothesis is that the FeNO~     concentration is more decreased in patients with a combination therapy compared to those with~     a corticosteroid mono therapy.~   "
232291|NCT00515762|"~     Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has~     been recently described. This pilot trial explores the capacity of a cooling cap (Elasto-gel)~     to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel~     regimens.~   "
232292|NCT00515736|"~     Critically ill patients are generally exposed to an increased oxidative stress, which is~     proportional to the severity of their condition. Endogenous antioxidant (AOX) defenses are~     depleted particularly in those patients with intense inflammatory response. The hypothesis~     tested is that early I:V: administration of a combination of AOX micronutrient supplements~     (Se, Zn, Vit C, Vit E, Vit B1) would improve clinical outcome in selected critically ill~     patients, by reinforcing the endogenous AOX defenses and reducing organ failure.~   "
232293|NCT00515723|"~     Hyperglycemia and type 2 diabetes mellitus are more common in schizophrenia than in the~     general population. Type 2 diabetes mellitus is characterized by disturbances in insulin~     action on skeletal muscle, liver and adipose tissue. Diabetes causes increased morbidity and~     mortality due to acute (e.g., diabetic ketoacidosis) and long-term (e.g., cardiovascular~     disease) complications. The combination of hyperglycemia, dyslipidemia and abdominal~     adiposity is even more strongly associated with increased cardiovascular morbidity and~     mortality. The association of type 2 diabetes and hyperglycemia with schizophrenia was first~     noted prior to the introduction of antipsychotic medications, suggesting that these patients~     may be at increased risk. Since then, however, additional glucoregulatory abnormalities~     (e.g., new onset diabetes), dyslipidemia, and increased weight and adiposity have all been~     associated with antipsychotic medications. Concern about antipsychotic effects on glucose,~     lipids and adiposity has increased recently, focusing on the widely-used newer medications,~     clozapine and olanzapine. Increased abdominal adiposity can secondarily decrease insulin~     sensitivity and antipsychotics can increase adiposity. However, medication effects on glucose~     control and insulin action may also occur independent of differences in adiposity. This~     project aims to a) evaluate the effects of selected antipsychotic medications on insulin~     action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue~     (whole-body lipolysis), b) evaluate the effects of selected antipsychotic medications on~     abdominal adipose tissue mass, total body fat and total fat-free mass, and c) explore the~     longitudinal effects of treatment with selected antipsychotics on glucose tolerance, lipid~     profiles, abdominal adipose tissue mass, total body fat and total fat-free mass. These~     hypotheses will be evaluated by measuring 1) whole-body glucose and lipid kinetics with the~     use of gold-standard stable isotope tracer methodology, 2) body composition using dual~     energy x-ray absorptiometry and magnetic resonance imaging, and 3) longitudinal changes in~     glucose tolerance and lipid profiles. The aims will be addressed in non-diabetic~     schizophrenia patients chronically treated with risperidone, olanzapine, clozapine,~     quetiapine, ziprasidone, or haloperidol, and untreated healthy controls. Re-evaluations will~     also be performed in patients who are randomized to switch from their current antipsychotic~     (from the above groups) to risperidone, olanzapine, quetiapine, or ziprasidone for 6 months.~     Relevant data is critically needed to target basic research, identify long-term~     cardiovascular consequences, and plan therapeutic interventions.~   "
232431|NCT00513864|"~     To develop and validate a non-invasive, in vivo, phenotyping method for CYP2D6 using the~     non-injurious neuroselective electrical stimulation technique: pain perception threshold/pain~     tolerance threshold (PPT/PTT) in children and adolescents with sickle cell disease.~   "
232294|NCT00515710|"~     Several subjects enrolled in a multi-site, gene transfer clinical study to evaluate the~     intrahepatic administration of AAV2-hFIX16 vector for the treatment of severe hemophilia B~     between 2001 and 2009. As the US FDA has established guidelines for the long-term follow-up~     (LTFU) of subjects receiving investigational gene therapy products, this protocol seeks to~     characterize the clinical outcome and the type and seriousness of adverse events following~     the AAV gene transfer. The primary study tools will consist of annual history/physical~     examination and blood tests, as well as periodic liver ultrasound, to characterize clinical~     outcomes. Where possible, data will be obtained for up to 15 years following hepatic~     AAV2-hFIX16 gene transfer.~   "
232295|NCT00515697|"~     The purpose of this study is to determine whether ramucirumab is effective treatment in~     participants with metastatic renal cell carcinoma who have developed progressive disease or~     become intolerant to tyrosine kinase inhibitor therapy.~   "
232296|NCT00515684|"~     The purpose of this study is to determine whether topical bevacizumab is safe or not when~     used in corneal neovascularization for long term period.~   "
232297|NCT00515671|"~     The President's New Freedom Commission on Mental Health has called for a transformation of~     the mental health system to partner with consumers of those services in delivering effective~     interventions focused on recovery, and the Department of Veterans Affairs (VA) has developed~     a Mental Health Strategic Plan to address these recommendations. One promising approach is to~     implement Illness Management and Recovery (IMR), a structured curriculum to help mental~     health consumers manage their illnesses and pursue goals related to recovery from mental~     illness.~      IMR was developed from a review of effective approaches for illness self-management training~     in persons with severe mental illness. The 9-month curriculum is taught using motivational,~     educational, and cognitive-behavioral techniques, and incorporates five evidence-based~     practices: education about mental illness, strategies for increasing medication adherence,~     skills training to enhance social support, relapse prevention planning, and coping skills~     training. The program was developed for widespread dissemination and includes a manual,~     worksheets, an introductory video, a clinical training video, a fidelity scale, and~     informational brochures for consumers, family members, clinicians, and administrators.~   "
232298|NCT00515658|"~     The aim of this study is to evaluate the safety and efficacy of theta-burst rTMS in patients~     with major depression. Patients will be randomized to receive ether left-sided intermittent~     theta-burst rTMS or rigt-sided continuous theta-burst rTMS or sham theta-burst rTMS over two~     weeks period with an option for an additional two weeks period, depending on treatment~     response. Clinical assessments will be performed weekly by the Hamilton depression rating~     scale. In addition, standard neurophysiological assessment of cortical excitability will be~     done.~   "
232299|NCT00515645|"~     Head down tilt (HDT) was widely used to simulate microgravity effects on cardiovascular~     system. HDT could be a suitable model of water immersion (WI) which is also used to simulate~     the cardiovascular effects of microgravity and which is not easy to study in laboratory. To~     define the possibility to simulate immersion by HDT, a comparison between these models is~     required. A comparison between WI and few angles during HDT seems necessary to understand~     which angle is more adapt.~      The immersion induces an increase of the central blood volume. This increase is caused by a~     redistribution of blood from peripheral portions of the body to the intrathoracic~     circulation. It seems to load cardiopulmonary and arterial baroreceptors. These baroreceptors~     bring into play autonomic nervous system (ANS) activation and induce a bradycardia.~      HDT induces an increase in central blood volume as supported by the central venous pressure~     and cardiac volume increase and in return, MSNA and heart rate decrease. These cardiovascular~     effects seem to be the same as the thermoneutral immersion and suggest that the ANS~     activation is the same during HDT and WI.~      Nevertheless, a few previous studies about ANS in HDT indicate some discordant results: a~     sympathetic decrease was reported but several results show an increase of parasympathetic~     activity linked with a trend of increase of arterial baroreflex. The aim of this study is to~     assess ANS activity in HDT on different angles (-6° and -15°) and WI. The investigators~     suppose an increase of parasympathetic activity during WI corresponding to parasympathetic~     activation during HDT especially at -6°.~   "
232300|NCT00515632|"~     Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin~     resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are~     at high risk of many serious diabetic complications, including cardiovascular disease,~     blindness, nerve damage and kidney damage. Balaglitazone is a thiazolidinedione derivative~     that is being developed as an oral anti-diabetic drug to improve blood glucose control in~     patients with type 2 diabetes. The purpose of this study is to assess if additional treatment~     with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve~     blood glucose control and decrease the daily insulin dose compared to placebo, but with less~     impact on weight gain and oedema than pioglitazone (Actos®) 45 mg.~   "
232301|NCT00515619|"~     The main purpose of this trial is to determine safety and efficacy of Lacosamide under long~     term therapy.~   "
232302|NCT00515606|"~     to assess the effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in~     sulfur mustard exposed patients with acute decompensation~   "
232303|NCT00515593|"~     The objectives of the study are~        -  to describe the quality of life at the beginning of the Preotact® treatment and at the~          end of the observational period (Qualeffo-41 questionnaire)~        -  pain assessment at the beginning of the Preotact® treatment and at the end of the~          observational period (VAS score)~        -  to describe bone mineral density at the beginning of the Preotact® treatment and at the~          end of the observational period (T-Score)~        -  to describe incidence of bone fractures caused by osteoporosis as well as of other~          pathological findings of the skeleton after the beginning of the Preotact® treatment~        -  to describe serum level of calcium and the bone resorption marker desoxypyridinoline~          (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the~          beginning of the Preotact® treatment and at the end of the observational period (only in~          subgroup of patients, where the physician sees a need to measure these parameters)~        -  to document all adverse drug reactions after the beginning of the Preotact® treatment~        -  the analysis of subgroups with different risk for bone fractures caused by osteoporosis~          at the beginning of the Preotact® treatment~        -  to assess the manageability and functioning of the Pen system for injection of Preotact®~          (self administered questionnaire)~   "
232306|NCT00515554|"~     This study is designed to test:~        1. in patients with negative positron-emission tomography (PET) after 2 cycles of~          BEACOPPesc chemotherapy: whether the number of cycles can be reduced without~          compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)~        2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc~          chemotherapy by adding Rituximab improves PFS.~   "
232307|NCT00515541|"~     This study is to determine the effects of Lovaza in platelet function studies~   "
232308|NCT00515528|"~     The purpose of this study is to determine if an experimental melanoma vaccine can produce an~     immune response in patients with metastatic melanoma, and if combining this vaccine with the~     drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor~     shrinkage.~   "
232309|NCT00515502|"~     GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being~     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long~     duration of action of GSK573719 when administered via inhalation in animal models supports~     the potential for use as a once-daily bronchodilator for COPD.~   "
232310|NCT00515489|"~     The purpose of this study was to evaluate the safety of risperidone treatment in acute~     psychotic patients that require an admission into emergency department. The effectiveness of~     risperidone in controlling acute psychotic symptomatology and incidence, severity and risk of~     psychomotor agitation in acute psychotic patients was also studied.~   "
232311|NCT00515476|"~     The purpose of the present study is to characterize the quality of HDL-Cholesterol in~     patients with metabolic syndrome and reduced blood HDL-Cholesterol levels and to examine the~     effect of exercise training on the vasculoprotective effects of HDL-Cholesterol in these~     patients. Additionally the investigators aim to investigate the endothelial function,~     oxidative stress and the regenerative capacity of the endothelial progenitor cells in~     patients with metabolic syndrome and the changes dependent on physical activity of patients.~   "
232312|NCT00515463|"~     The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled~     syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density~     (BMD).~   "
232313|NCT00515450|"~     This randomized controlled, multi-center study will carry out to assess the efficacy of~     GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis~     based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint,~     and in addition, to assess the safety of GB-0998~   "
232314|NCT00515437|"~     To determine safety, tolerability and preliminary efficacy of intraglandular injections of~     MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients~   "
232315|NCT00515424|"~     This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and~     explore the effect of the compound on intraocular pressure in subjects with ocular~     hypertension.~   "
232316|NCT00515411|"~     Chemotherapy given together is a standard way to treat your cancer. One standard treatment~     includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original~     combination of these three drugs can cause many side effects. This study is being done to~     find out if these three drugs can be given at lower doses more often, with fewer side effects~     and still maintain the same benefit as the standard way of giving this three drug~     combination. If your tumor overexpresses a protein called Her2, you are also eligible to~     receive trastuzumab with chemotherapy. Trastuzumab is a medicine that has been approved by~     the US Food and Drug Administration for the treatment of Her2 positive breast cancer.~     Trastuzumab is now also a standard treatment in combination with chemotherapy for the~     treatment of Her2 positive stomach cancer. If your tumor is Her2 positive, you would receive~     the modified administration schedule of docetaxel, cisplatin, and fluorouracil with~     trastuzumab.~   "
232317|NCT00515398|"~     The purpose of this study is to see how molecules called pharmacological chaperones affect~     the cells of patients with Pompe disease. The study will last 1 or 2 visits which will~     include a blood collection, urine collection, and two skin biopsies. Information will also be~     collected from the medical records about disease history and diagnosis. Patients will not~     receive any study medication.~   "
232318|NCT00515385|"~     The primary purpose of this phase 1, double-blind, cohort study is to evaluate the safety,~     tolerability, and pharmacokinetics of escalating doses of MGAWN1 administered as a single~     intravenous (IV) infusion to healthy adults. Subjects will be enrolled sequentially into one~     of 5 dose-level cohorts, with 8 subjects in each cohort. Six subjects in each cohort will~     receive MGAWN1 (a Neutralizing, Humanized, Monoclonal Antibody (IgG1k) to West Nile Virus)~     and 2 will receive a saline control.~   "
232319|NCT00515372|"~     The goal of this behavioral research study is to find a quick and effective way to identify~     depression in patients with ovarian, peritoneal, or fallopian tube cancer. Another goal of~     this study is to compare an intervention program with enhanced standard care to see which~     may be more effective in improving quality of life for these patients.~   "
232320|NCT00515359|"~     RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI~     Studies~   "
232321|NCT00515346|"~     The purpose of this study is to evaluate the safety and performance of the Xpert(TM)~     self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in~     patients undergoing percutaneous intervention for the treatment of documented chronic~     critical limb ischemia (CLI).~   "
232322|NCT00515333|"~     The primary objective of the study is to investigate the effects of oral TRx0014 at three~     doses (30, 60 and 100 mg tid) compared with placebo on cognitive ability in patients with~     mild or moderate dementia of the Alzheimer type. Cognitive ability will be measured by the~     Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog). The primary evaluation~     will be made at 24 weeks.~   "
232323|NCT00515320|"~     The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets~     (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic~     Disorder. The study will also investigate the effect of fluoxetine on the improvement of~     symptoms and the effects on daily living of the patient's family.~   "
232367|NCT00514748|"~     Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP~     flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA. This~     study is aimed to build a interconnected vessel system of bilateral DIEP flap based on one~     vessel pedicle and observe its survival in breast reconstruction.~   "
232324|NCT00515307|"~     Patients with homozygous familial hypercholesterolemia has very high serum cholesterol levels~     despite receiving lipid lowering drugs (e.g. statins, etc). Most of such patients die before~     the age of 20 due to myocardial infarction, etc. Orthotopic liver transplantation (OLT) is an~     effective treatment for that. Hepatocyte transplantation is an alternative to OLT that may~     help to overcome the shortage of donor organs. There have been reports of successful~     treatment of different kinds of metabolic liver disorders by hepatocyte transplantation. The~     major problem with hepatocyte transplantation is that the source of hepatocytes is very~     limited. Bone marrow stem cells are the potential source of hepatocytes. In the in-vitro~     culture system successful and efficient transdifferentiation of mesenchymal stem cells into~     hepatocytes has been documented. We have already shown that infusion of mesenchymal stem~     cells is safe and feasible in cirrhosis (Mohamadnejad M, et al. Arch Iran Med 2007; In~     Press). In this study, 2 patients with homozygous familial hypercholesterolemia will be~     included. The bone marrow of healthy volunteers with a normal lipid profile will be taken,~     then bone marrow mesenchymal stem cells (MSCs) will be cultured, and then MSCs will be~     trans-differentiate into hepatocytes, and the cells will be infused through the portal vein~     into the patients. The duration of follow up will be 6 months post-transplantation.~   "
232325|NCT00515294|"~     The aim of this study is to develop information about the acute and residual effects of a new~     product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial~     model study design, we will compare the acute and residual effects on driving impairment of~     caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated~     placebo. Under the alcohol conditions, participants will receive sufficient alcoholic~     beverage to attain a blood alcohol concentration (BAC) of .12 g%. Participants will be 144~     undergraduate and graduate students, and recent college graduates.~   "
232326|NCT00515281|"~     The purpose of this study is to determine whether inhaled nitric oxide improves the~     neurological outcome for premature infants.~   "
232327|NCT00515268|"~     The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a~     lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin~     (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support~     GSK256066 dose selection for future studies in COPD patients.~   "
232328|NCT00515255|"~     The purpose of this study is to investigate the effect of NPL-2003 on the symptoms of~     Obsessive Compulsive Disorder (OCD) in an adolescent population.~   "
232329|NCT00515242|"~     The purpose of this study is to compare the relative effectiveness of three relaxation~     treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in~     reducing anxiety in persons with Generalized Anxiety Disorder.~   "
232330|NCT00515229|"~     Our data indicate that the CFTR-molecule functions as a transporter for~     sphingosine-1-phosphate and sphingosine or regulates the uptake of these sphingolipids by~     epithelial cells. The disturbed uptake of sphingosine and sphingosine-1-phosphate over the~     cell membrane results in an accumulation of ceramide in the cell membrane, which finally~     triggers a pro-inflammatory and pro-apoptotic status in the respiratory tract of cystic~     fibrosis patients. Amitriptyline reduces the cera-mide levels in the lung tissue, normalises~     the activity of cytokines and prevents constitutive cell death of epithelial cells observed~     in CFTR-deficient mice. Most important, amitriptyline prevents pulmonary infections of~     CFTR-deficient mice with P. aeruginosa. These effects of amitriptyline may result in an~     improved lung function of cystic fibrosis patients.~   "
232331|NCT00515216|"~     This study is for patients who have stomach cancer or cancer of the lower part of the~     esophagus that has spread to other organs. There are many different chemotherapy treatments~     for this type of cancer. At the present time, there is no general agreement on the way to~     choose the most beneficial therapy for an individual patient. Patients with different genetic~     backgrounds may respond differently to the same chemotherapy treatments. In this study the~     investigators will use a certain genetic difference in an important gene (thymidylate~     synthase or TS gene) to see whether treating patients who have a particular type of that gene~     will respond better to a standard chemotherapy regimen. The investigators are hoping that by~     treating patients according to their genes, that they may respond to treatment of their~     cancer better and it will help the investigators choose cancer treatments better in the~     future.~   "
232332|NCT00515203|"~     The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531)~     in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also~     evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of~     romiplostim (AMG 531). It is anticipated that romiplostim (AMG 531), when given at an~     effective dose and schedule, will be well tolerated treatment for thrombocytopenia among~     pediatric subjects with chronic ITP.~   "
232333|NCT00515190|"~     Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus~     oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with~     recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction~     chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression~     will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus~     oxaliplatin arm in a 1:1 ratio.~   "
232349|NCT00514982|"~     This study will determine if medical treatment of colitis (inflammation of the colon~     resulting in loose bowel movements, rectal bleeding, and belly pain) that is used for other~     colitis conditions, such as Crohn's disease and ulcerative colitis, is safe and effective for~     treating colitis in patients with Hermansky-Pudlak syndrome (HPS). HPS is a hereditary~     disorder that causes albinism, visual impairment, and abnormal bleeding. Some patients also~     develop colitis, pulmonary fibrosis, and kidney disease.~      Patients with HPS and colitis who are 18 years of age or older may be eligible for this~     study. Participants receive treatment for their colitis symptoms with one or more of several~     study drugs, which include mesalamine (5-ASA), corticosteroids, infliximab and~     6-mercaptopurine, adalimumab and tacrolimus. The drugs are added to the treatment plan one at~     a time to find the combination that works best for the individual patient. Patients who~     respond to one or more of the medications may continue treatment with that same combination~     for up to 6 months.~      Regular clinic visits are scheduled for blood tests, symptoms ratings questionnaires and~     periodic physical examinations and colonoscopies to measure the response to treatment and~     evaluate any side effects.~   "
232432|NCT00513851|"~     Open label, phase 1, dose escalation~   "
232334|NCT00515177|"~     Chronic insomnia is a major public health problem that affects about 10% of adults and is~     associated with serious and distressful health consequences such as depression, anxiety and~     reduced quality of life. Sleep medications are effective, but side effects, costs and~     uncertain long term efficacy call for non-pharmacologic alternatives. Mindfulness-Based~     Stress Reduction (MBSR), a standardized program of training in mindfulness meditation and~     yoga, is a promising new approach for treating chronic insomnia. MBSR was developed to~     facilitate adaptation to the stressors of medical illness. It is hypothesized that~     mindfulness training reduces arousal and unhelpful cognitions that promote and sustain~     chronic insomnia. The Mindfulness Versus Pharmacotherapy trial (MVP#1) is a pilot study~     designed to establish the feasibility and determine the optimal design for a full-scale trial~     comparing MBSR to prescribed sleep medication for treatment of chronic insomnia. For this~     pilot, we will randomize persons with primary chronic insomnia (actual sample of 30 persons)~     to 2 groups : 1) MBSR (8-weeks of group instruction followed by 3-months of home practice);~     and 2) PCT (3 mg of LUNESTA(eszopiclone) nightly for 8-weeks followed by 3-months of as~     needed use). Both groups will have telephone monitoring for side effects, adherence~     tracking, and objective sleep assessment by actigraphy. The primary outcomes are sleep~     quality, sleep quantity and insomnia severity assessed by well-validated self-report scales,~     objective sleep parameters measured by wrist actigraphy, depression and anxiety symptoms,~     health-related quality of life and workplace productivity. We hypothesize that those in the~     MBSR group will have improved sleep outcomes. Outcomes will be assessed at 8-weeks (the end~     of the active intervention phase) and 5 months follow-up. Outcomes will be compared to~     baseline values and measures reflecting proposed mechanisms of action to determine if~     clinically important impacts are likely to be obtainable in a full-scale trial. After~     follow-up data have been collected, participants will be invited to participate in focus~     groups to share their impressions of the study interventions to identify issues that could be~     addressed in a full-scale trial. Our long-range goal is to provide evidence-based~     recommendations for safe, practical and cost-effective non-pharmacologic treatment options~     for chronic insomnia.~   "
232335|NCT00515164|"~     The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System in~     patients with advanced upper lobe predominant emphysema.~   "
232336|NCT00515151|"~     Health-care-acquired infections are of tremendous importance for patients, especially~     catheter-associated infections. More than 40% of all bloodstream infections are associated~     with central venous catheters (CVC; catheters which are inserted into a large vein near the~     heart). Of all patients that acquire such an infection 1% to 5% die as a result from it. The~     insertion site is the main source of contamination and infection. In general, bacteria of the~     skin are the cause of infection, especially in short-term CVCs (10-14 days). Therefore it is~     necessary to efficiently disinfect the skin for the preparation and care of CVC insertion~     sites. Several substances are used for disinfection. Alcohol-based disinfectants are mainly~     used in Central Europe, other preparations contain povidine-iodine or chlorhexidine.~     Alcoholic disinfectants have a rapid initial effect, chlorhexidine shows an additional~     remanent (longer lasting) effect. A further substance, octenidine dihydrochloride, also~     demonstrated a remanent effect in a pilot study with neurosurgical patients. The purpose of~     our study is to compare an alcohol-based disinfectant containing octenidine dihydrochloride~     with a pure alcoholic disinfectant regarding efficacy and tolerability in patients receiving~     a CVC for a minimum of 5 days.~   "
232337|NCT00515138|"~     This study seeks to determine the maximum tolerated dose of bortezomib in combination with~     rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary~     refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell,~     follicular grade III, transformed lymphoma). Subjects will be enrolled in cohorts of 3 at~     each bortezomib dose level, starting at 1 mg/m(2), and escalating to 1.3, 1.5, and 1.7~     mg/m(2). Bortezomib will be given on days 1 (prior to rituximab) and 4, rituximab 375~     mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days~     6-13 or pegfilgrastim on day 6.~   "
232338|NCT00515125|"~     The purpose of this study is to determine the best form of dietary intervention to~     undernourished elderly individuals in care homes.~      The research aims to test the null hypothesis that there is no difference between oral~     nutritional supplements and dietary advice as the first line treatment for malnutrition.~   "
232339|NCT00515112|"~     The purpose of this study is to determine whether prostate cancer growth can be slowed in~     patients who receive Androgel® 1% at 10 gram dose.~   "
232340|NCT00515099|"~     Antithymocyte globulin (e.g., Thymoglobulin®) is an antibody preparation that is commonly~     used to treat and prevent organ transplant rejection. The START trial aims to determine~     whether antithymocyte globulin (ATG) treatment can halt the progression of newly diagnosed~     type 1 diabetes when given within 12 weeks of disease diagnosis.~   "
232341|NCT00515086|"~     This study will define the safety and efficacy of Everolimus (RAD001) administered daily in~     patients with glioblastoma multiforme (GBM)~   "
232342|NCT00515073|"~     Primary Objectives:~        -  To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary~          serous carcinoma of the endometrium for both local control and overall survival.~        -  To evaluate the toxicity of Paclitaxel and pelvic radiation.~        -  To collect and evaluate patients' quality of life/symptom assessment data.~   "
232343|NCT00515060|"~     The Aim of this Study is to examine the feasibility of using quantitative sensory testing~     procedures, widely applied to the experimental study of sensory processing in humans both~     with and without various pain syndromes, to now characterize the psychophysical properties of~     neuropathic pain that has developed as a consequence of cancer therapy. Skin punch biopsies~     will be performed in patients with chemotherapy-induced pain to determine whether the~     impairment of nerve function is due to actual retraction or loss of innervation to the skin~     in areas affected by sensory disturbance.~   "
232344|NCT00515047|"~     People with atopic dermatitis (AD), or eczema, are susceptible to skin infections and~     inflammations. Some individuals with AD develop a condition known as eczema herpeticum (EH)~     following exposure to the herpes simplex virus (HSV). The purpose of this study is to~     identify the genetic determinants that lead people with AD to develop EH and similar~     conditions caused by other viruses.~   "
232345|NCT00515034|"~     The purpose of this study is to assess the safety and tolerability of doripenem compared to~     imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The~     study population will include hospitalized patients (or patients resident in a chronic health~     care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated~     Intra-abdominal Infection.~   "
232346|NCT00515021|"~     To determine if nighttime administration of an aldosterone antagonist would effectively lower~     peak plasma PAI-1 levels more effectively than morning administration.~   "
232347|NCT00515008|"~     The purpose of this study is to obtain preliminary data on the effects of Tai Chi on~     musculoskeletal pain, fatigue, sleep quality, psychological distress, physical~     performance,and health status in 60 patients with fibromyalgia.~   "
232350|NCT00514969|"~     This is a phase II, multi-center, open-label, non-randomized trial. During Part 1 of the~     trial, patients will receive once daily oral administration of STI571 at a dose of 600 mg for~     24 weeks. After completing 24 weeks of therapy, patients may be eligible to receive~     additional therapy during Part 2 of the trial provided that, in the opinion of the~     investigator, the patient has benefited from treatment with STI571 and in the absence of~     safety concerns. During Part 2 (which is of indefinite duration), patients will continue to~     receive STI571 on a daily basis until either death, the development of intolerable toxicity~     or the investigator feels it is no longer in the patient's best interest to continue therapy,~     whichever comes first.~   "
232351|NCT00514956|"~     A great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic~     Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of~     the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. The study proposes~     to determine whether a very brief course of treatment (3 sessions) with a common form of~     Energy Psychology called Emotional Freedom Techniques (EFT) has an effect on the stress~     biochemistry of subjects, by measuring their levels of stress hormones (cortisol, DHEA)~     before and after treatment.~   "
232352|NCT00514943|"~     The primary objective of this study is to explore the efficacy of BIBW 2992 compared with~     cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after~     failure of platinum-containing therapy. In addition, the trial aims to clarify the influence~     of EGFR genotype on tumor response to the treatment regimens.~   "
232353|NCT00514930|"~     The primary aim for this trial is to assess whether the RFA aspirator device is safe and of~     clinical benefit in patients with primary or secondary malignant liver tumours~   "
232354|NCT00514917|"~     The primary objective was to evaluate and compare the efficacy of androgen deprivation with~     or without docetaxel as determined by the median progression free survival (PFS) over the~     period of 18-month therapy and at least 18-month follow-up.~      The secondary objectives were:~        -  To assess cancer specific survival;~        -  To compare overall survival between the 2 treatment groups;~        -  To evaluate patient-reported outcomes including quality of life, fatigue, and sexual~          functioning as measured by 3 different assessments.~   "
232355|NCT00514904|"~     The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority~     of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
232356|NCT00514891|"~     High-dose vitamin A to children above 6 months of age reduces all-cause mortality by 23-30%.~     The WHO recommends vitamin A supplementation (VAS) with the first vaccine after 6 months of~     age. However, the effect of providing VAS with vaccines has never been investigated. We have~     hypothesised that the effect of VAS depends on the immune stimulus at the time of~     supplementation. Hence, the effect might vary depending on which type of vaccine it is given~     with. In particular, we hypothesised that VAS might be beneficial when given with measles~     vaccine but not when given with DTP vaccine. Normally the first vaccine after 6 months of age~     would be a measles vaccine, but many children come late for their DTP vaccinations and~     receive DTP alone or together with measles vaccine. Hence, it is important to study whether~     the effect of VAS is the same irrespective of the vaccine(s) administered at the same time.~      Guinea-Bissau has not yet implemented the WHO vitamin A policy of providing VAS with~     vaccines, but plans to do so within the next years. Together with the Ministry of Health in~     Guinea-Bissau, the Bandim Health Project (BHP) in Guinea-Bissau will investigate the effect~     on mortality and morbidity of implementing the WHO vitamin A policy in Guinea-Bissau. This~     will be done in a large randomised trial.~      BHP has a demographic surveillance system (DSS) which has followed a population of now more~     than 150,000 individuals for almost 30 years. Children will be randomised to receive VAS or~     placebo with their first vaccine after 6 months of age, and will be followed through the DSS~     to assess mortality and morbidity. Based on previous observations, the effects of VAS might~     differ according to sex and season. The interaction between VAS, sex, and season will also be~     studied in the present trial. By identifying situations where VAS may be beneficial,~     ineffective, or even harmful the study may contribute importantly to optimising the VAS~     policy for low-income countries.~   "
232357|NCT00514878|"~     The primary purpose of this prospective cohort study is to develop a simplified risk model~     for post-discharge nausea and vomiting (PDNV) in adult same-day surgery patients in the US~     that will allow clinicians to identify those patients who would benefit from prophylactic~     antiemetic strategies.~   "
232358|NCT00514865|"~     The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients~     with Recurrent Major Depressive Disorder~   "
232359|NCT00514852|"~     The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will~     be compared to a currently-available artificial tear~   "
232360|NCT00514839|"~     In a randomized controlled trial, patients recruited in a general hospital and fulfilling~     criteria for regular consumption (more than 60 days within the last three months), dependence~     or abuse of prescription drugs will be randomly allocated to two conditions:(1) Intervention~     group consisting of two counselling sessions based on Motivational Interviewing plus a~     personalized feedback, (2) Control group receiving a booklet on health behavior.~      Outcome assessment will be conducted after 12 months. The hypothesis is that counseling leads~     to greater reduction in consumption of prescription drugs (including discontinuation) and~     elevated readiness to change at follow-up.~   "
232361|NCT00514826|"~     The purpose of the study is to investigate the effect of an altitude sojourn on patients with~     the obstructive sleep apnea syndrome~   "
232362|NCT00514813|"~     To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in~     patients treated with Dynepo.~   "
232363|NCT00514800|"~     Design: Community based randomised trial with follow up after 12 months Participants: 360~     patients admitted with stroke or TIA within the past 9 months will be recruited from the~     wards or outpatients and randomly allocated into two groups. All patients will be visited by~     the specialist nurse at home at baseline when she will measure their BP and administer a~     questionnaire. The questionnaire and BP will be repeated at 12 months follow-up by another~     researcher blind as to whether the patient is in intervention or control group.~      Intervention: Intervention patients will be given a validated home BP monitor and support~     from the specialist nurse. Control patients will continue with usual care (BP monitoring by~     their practice).~      Main outcome measures in both groups after 12months: 1.Change in systolic BP 2.Cost~     effectiveness: Incremental cost of the intervention to the NHS and incremental cost per~     quality adjusted life year gained.~      Study hypothesis. Home blood pressure monitoring with nurse support wil lead to lower blood~     pressure after 12 months compared with usual GP care~   "
232364|NCT00514787|"~     Screen for moderate to severe asthma patients with suboptimal asthma control (as defined by~     GINA-Guidelines). Document current asthma control status. Re-evaluate asthma therapy and~     document new therapy if applicable.~   "
232369|NCT00514722|"~     This is a pilot study designed to evaluate the safety and feasibility of performing umbilical~     cord blood transplants in adults with high-risk hematopoietic malignancies. A novel~     myeloablative preparative regimen will be used. One, up to a maximum of three cord blood~     units will be administered to facilitate engraftment.~   "
232370|NCT00514709|"~     DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs~     for immunization in infancy, while offering the benefit of a reduced number of injections,~     and potentially of an increased acceptance.~      Primary Objectives:~        -  To describe the antibody persistence at 12 to 18 months following a three-dose primary~          series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14~          weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.~        -  To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18~          months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or~          Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine~          given at birth.~      Secondary Objective:~        -  To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when~          administered concomitantly with Oral Polio Vaccine (OPV).~   "
232371|NCT00514696|"~     The purpose of this study is to evaluate the safety of GCS-100 and the biologic activity of~     GCS-100 in subjects with chronic lymphocytic leukemia.~   "
232372|NCT00514683|"~     The general purpose of this trial is to investigate the efficacy and safety of 4 dose~     strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with~     idiopathic pulmonary fibrosis.~      The primary objective of this study is to demonstrate whether at least one dose strategy is~     superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital~     Capacity (FVC).~      As a secondary objective, additional parameters will be assessed in order to differentiate~     between dose strategies on the basis of safety and efficacy~   "
232373|NCT00514670|"~     The objective of the trial is to assess the impact of a disinfection and hand hygiene program~     on absenteeism in elementary school classrooms. Students in intervention classrooms will use~     alcohol-based hand sanitizers at school, and their classrooms will be disinfected using~     quaternary ammonium wipes. We hypothesize that the use of disinfectants and hand hygiene~     products in elementary school classrooms will reduce absenteeism.~   "
232374|NCT00514657|"~     The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce~     regeneration of periodontal tissue lost by progression of periodontitis and evaluated the~     safety of such induction.~   "
232375|NCT00514644|"~     The odontological radiology method Panorama is known to be able to spot calcifications in the~     area of the carotid arteries. The calcifications could be carotid stenoses which is~     affiliated with an increased risk of stroke. The study aims to investigate if panorama~     examinations can be used as a starting point for further investigation of the carotid~     arteries.~   "
232376|NCT00514618|"~     A. Null Hypothesis:~      In term pregnancies complicated by diabetes, there is no difference in the time interval from~     start of induction to delivery when outpatient cervical ripening and labor induction is~     initiated with orally administered misoprostol, a prostaglandin El analogue, compared to~     placebo.~      B. Specific aims:~        1. Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo~          when given in an outpatient basis to women with pregnancies complicated by diabetes~          mellitus.~        2. Demonstrate that oral misoprostol can be administered safely in an outpatient setting.~          The patients will be observed for a period of four hours in an outpatient antepartum~          testing unit after the medication is administered to demonstrate fetal well being and~          verify that there is no evidence of uterine hyperstimulation. (We acknowledge that~          markers of serious adverse maternal and neonatal outcomes are rare, and can only be~          adequately addressed in large multicenter trials.)~        3. Assess the cost differential in inpatient and outpatient utilization of misoprostol for~          cervical ripening and labor induction. In order to estimate the impact that outpatient~          cervical ripening may have on total hospitalization costs, we will use daily hospital~          charges and published data regarding pharmaceutical costs.~   "
232377|NCT00514605|"~     Each year up to 22 million persons in the US are tested for HIV. Currently available rapid~     tests do not provide test results for at least 30 minutes from the collection of serum and~     plasma from the subject. Providing accurate test results in less than a minute would make it~     easier to make timely decisions about treatment and counselling.~      This study will compare results of an experimental rapid test to existing standards to~     determine if the test can reliably and accurately diagnose HIV in less than one minute.~   "
232378|NCT00514592|"~     A single center observational study. Observing the time between cerebrovascular symptoms and~     Carotid Endarterectomy (CEA) and patient outcome. An intervention at 17 of the 29 study~     months aimed at reducing the delay and increasing the patient safety. Main outcome is to~     measure the reduction in recurrent stroke with decreased delay to CEA.~   "
232379|NCT00514579|"~     The hypothesis of the study is double unit umbilical cord blood transplantation in adults~     will be associated with a one year survival rate of at least 40%.~   "
232380|NCT00514566|"~     Within the last decade the customary trend of using non absorbable sutures has changed, with~     numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming~     comparable wound strength with significantly lower incidence of wound complications. It was~     the objective of this randomized clinical trial to compare two universally accepted suture~     materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline~     abdominal closure in the Indian context.~   "
232400|NCT00514293|"~     RATIONALE: Bexarotene and tretinoin may cause tumor cells to look more like normal cells, and~     to grow and spread more slowly. Drugs used in chemotherapy, such as cisplatin, carboplatin,~     docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving bexarotene and tretinoin~     together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving bexarotene~     together with tretinoin and combination chemotherapy works in treating patients with stage~     III or stage IV non-small cell lung cancer.~   "
232461|NCT00513448|"~     The purpose of this study was to determine whether a group wellness intervention or~     individualized physical rehabilitation was more effective in improving health and physical~     activity in persons with multiple sclerosis.~   "
232381|NCT00514553|"~     This study will compare the effectiveness of two interventions to help women make informed~     choices about whether or not to undergo an invasive procedure (amniocentesis or chorionic~     villus sampling) for prenatal testing. The interventions are: 1) conscious deliberation~     (getting women to focus on and engage in the decision) and 2) unconscious deliberation~     (getting women not to focus on the decision). Studies suggest that some women are ambivalent~     about their decisions regarding invasive prenatal testing and those with the most ambivalence~     experience greater conflict about the decision. Techniques to reduce ambivalence through~     conscious or unconscious deliberation might lead to better informed choices. The two methods~     will also be compared with standard counseling for prenatal testing decisions.~      Women 18 years of age or older who are referred for prenatal genetic counseling to consider~     invasive prenatal testing and who have not previously undergone prenatal testing may be~     eligible for this study.~      Participants complete a questionnaire before and after receiving standard genetic counseling.~     They are then randomly assigned to one of three study groups:~        -  Standard genetic counseling (control group): Receives no further intervention beyond~          standard counseling.~        -  Conscious deliberation: Participants complete a form that focuses their attention on the~          pros and cons of invasive prenatal testing. This is followed by a brief questionnaire to~          evaluate time spent thinking about the session and the ease of completing the session.~        -  Unconscious deliberation: Participants are provided a distraction task to complete~          during the session, such as a word or number puzzle and are told they will be asked~          about their decision regarding invasive prenatal testing at the end of the session. This~          is followed by a brief questionnaire to evaluate time spent thinking about the session~          and the ease of completing the session.~      Participants are contacted by telephone 1 month after the counseling session to find out what~     they decided regarding invasive prenatal testing and to assess any conflict they experienced~     about the decision.~   "
232382|NCT00514540|"~     The goal of this clinical research study is to learn about how effective 2 different~     schedules of chemotherapy drugs (Paraplatin [carboplatin] plus Taxotere [docetaxel] and~     VePesid [etoposide] plus Platinol-AQ [cisplatin]) are in the treatment of patients with~     anaplastic prostate cancer. The safety of both therapy combinations will also be studied.~   "
232383|NCT00514527|"~     Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment~     of complicated skin and skin structure infections (cSSSI) have been completed.~      The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the~     potential to be used safely and effectively when given either as a single dose or as an~     infrequent dose for cSSSI. Data from animals support this theory.~      SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of~     oritavancin or an infrequent dose of oritavancin (First dose on Day one with an option for a~     second dose on Day five) compared to the previously studied dosing regimen of 200mg~     oritavancin given once daily for 3 to 7 days.~   "
232384|NCT00514514|"~     The purpose of this study is to compare renal function of immunosuppressive regimens with~     different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low~     dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.~   "
232385|NCT00514501|"~     This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS~     patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123~     for the detection of myocardial ischemia. Readers independent of the clinical study centers~     will review results of imaging studies in a blinded fashion at an imaging core lab. The~     resulting independent reading of the images will be compared against the truth standard for~     ACS.~   "
232386|NCT00514488|"~     This is a phase III multicenter, open-label study designed to investigate the efficacy~     (hematological response, cytogenetic response and molecular response) and feasibility~     (tolerance, compliance and safety) of the tyrosine kinase inhibitor imatinib mesylate~     (formerly STI 571, GLIVEC, Novartis Pharma) at conventional dose (400 mg/daily) if compared~     with high dose (800 mg/daily) (serial number protocol ICSG/CML/022) in patients with Ph+~     chronic myeloid leukemia (CML) in chronic phase (CP) previously untreated, at high Sokal~     risk.~   "
232387|NCT00514475|"~     The purpose of the study is to determine if outcome for patients with mantle cell lymphoma is~     improved by adding radioimmunotherapy to high-dose regimen before auto-transplant in patients~     who are not in CR after induction therapy.~   "
232388|NCT00514462|"~     The purpose of this study is to determine that 830nm diode laser directly above the~     transverse carpal ligament (between the pisiform and navicular bone) on subjects' wrists, and~     test this therapeutic effect.~   "
232389|NCT00514449|"~     The purpose of this study is to examine whether antiviral medication will help improve~     psychotic symptoms and cognition in individuals early in the course of schizophrenia or~     schizoaffective disorder who are exposed to herpes simplex virus, type 1 (HSV 1), a virus~     that causes commonly occurring and recurrent cold sores.~   "
232390|NCT00514436|"~     Asthma among low-income, minority children remains a prime example of health disparities that~     are resistant to change. Controlled demonstrations of reductions in disproportionate hospital~     or emergency care are limited. We performed a controlled clinical trial of an Asthma Coach~     to reduce hospitalizations among low-income, African American children.~   "
232391|NCT00514423|"~     Participation in one of the three interventions psychoeducation by professionals,~     psychoeducation by peer-moderators, or video-education can reduce the rehospitalisation rate~     of patients with schizophrenia compared to a control group.~   "
232392|NCT00514410|"~     To determine whether giving folic acid to people with depression will help their~     antidepressants work better. If folate does help antidepressants to work better, then it will~     provide a safe, simple and cheap way of improving the treatment of depression.~   "
232393|NCT00514397|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together~     with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation~     therapy works in treating young patients with pontine glioma.~   "
232394|NCT00514384|"~     Evaluation of serial measurement of novel biomarker for diagnosis, prognosis or therapy~     monitoring in patients presenting with acute decompensated heart failure.~   "
232395|NCT00514371|"~     This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma.~     Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a~     fixed dose of bortezomib.~   "
232396|NCT00514358|"~     The purpose of this study is to determine the pharmacokinetics of fluconazole in infants and~     evaluate the dose exposure relationship of current fluconazole dosing in infants who are~     receiving fluconazole for the prevention or treatment of systemic fungal infections.~   "
232397|NCT00514345|"~     RATIONALE: Studying the genes expressed in samples of blood from young patients with cancer~     treated with ifosfamide may help doctors identify risk factors for kidney damage.~      PURPOSE: This clinical trial is looking at the CYP3A5 gene to see if having the gene may be a~     risk factor for kidney damage in young patients with cancer treated with ifosfamide.~   "
232398|NCT00514332|"~     To evaluate wether colorectal stenting carry a significant clinical advantage~   "
232401|NCT00514280|"~     This study will test whether a short interview session about lead and secondhand tobacco~     smoke can help pregnant women reduce their exposure to lead and secondhand smoke. Both lead~     and secondhand tobacco smoke can cause problems with a pregnancy. The best way to prevent~     exposure to lead and secondhand tobacco smoke is to recognize the sources and avoid them.~      Non-smoking African-American and Hispanic pregnant women between 18 and 49 years of age who~     live in Washington, D.C. may be eligible for this study.~      Participants are randomly assigned to one of two study groups. Both groups have a 30-minute~     one-on-one session with a member of the study staff. The content of the session differs~     between groups. In addition, all women undergo the following tests and procedures:~        -  Answer questions about themselves, their pregnancies, diet, home and smokers in the~          home.~        -  Requested to provide permission to obtain medical records of children older than 12~          months of age who have ever been seen at Children's National Medical Center.~        -  Blood draws at least four times during the study: at the time of enrollment, during the~          second trimester of the pregnancy, during the third trimester, and at the time of~          delivery. Up to three optional blood samples may also be requested, one during each~          trimester of the pregnancy. Blood samples are used to measure lead, cotinine (a chemical~          the body makes out of nicotine) and hematocrit (a test for anemia).~        -  Collection of umbilical cord blood at the time of delivery.~        -  Answer questions after the delivery about the patient's health, the delivery and the~          baby.~   "
232402|NCT00514267|"~     To determine the feasibility and safety of administering YM155 in combination with docetaxel~   "
232403|NCT00514254|"~     RATIONALE: Learning about the risk factors for endometrial cancer in black women may help the~     study of endometrial cancer in the future.~      PURPOSE: This clinical trial is studying risk factors for endometrial cancer in black women.~   "
232404|NCT00514241|"~     The aim of platelet rich plasma (PRP) application is to accelerate the healing cascade via~     application of elevated cytokine concentrations released during platelet degranulation.~      This is a prospective randomized study of the effect of autologous platelet concentrate~     application during surgical closure following a vein harvest during coronary bypass surgery.~     This prophylactic measure will be compared to standard surgical closure techniques with the~     primary outcome being the incidence of leg wound infection.~   "
232405|NCT00514228|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     liver cancer that cannot be removed by surgery.~   "
232406|NCT00514215|"~     RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving an injection of GM-CSF~     before cryotherapy and inhaling GM-CSF after cryotherapy may interfere with the growth of~     tumor cells and shrink the tumor. Giving cryotherapy together with GM-CSF may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving cryotherapy together with GM-CSF~     works in treating patients with lung metastases or primary lung cancer.~   "
232407|NCT00514202|"~     Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this~     medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot~     study will determine the ability of dextroamphetamine to treat individuals with both cocaine~     dependence and ADHD.~   "
232408|NCT00514189|"~     Primary Objectives:~        1. To determine the feasibility of delivering autologous dendritic cells (DCs) loaded with~          acute myelogenous leukemia (AML) lysate plus messenger RNA (mRNA) to AML patients~          following consolidation therapy.~        2. To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA.~        3. To quantitate immune responses in patients who receive autologous DCs loaded with AML~          lysate plus mRNA.~      Secondary Objectives:~        1. To evaluate minimal residual disease following DC therapy using the polymerase chain~          reaction assay for the Wilm's Tumor-1 gene.~        2. To asses the disease-free and overall survival of AML patients who receive the~          autologous DCs loaded with AML lysate plus mRNA.~   "
232409|NCT00514163|"~     The primary objective of this study is to compare tumor response rate of the test~     arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable~     pancreatic cancer~   "
232410|NCT00514150|"~     Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients~     undergoing diagnostic or interventional procedures requiring radiographic contrast agents.~     Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline( the~     uniformly accepted prophylaxy) in preventing RCIN.Therefore the aim of the study is to~     evaluate the efficacy of sodium bicarbonate solved in normal saline compared with infusion of~     normal saline in prevention of RCIN.~   "
232411|NCT00514137|"~     This phase II trial is studying how well sunitinib works in treating patients with relapsed~     multiple myeloma. Sunitinib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the cancer~   "
232412|NCT00514111|"~     The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients~     treated with pegylated-interferon or conventional-interferon and ribavirin, and to~     investigate the associated factors with RVS, by means of retrospective analysis.~   "
232413|NCT00514098|"~     A new approach to HIV prevention currently being studied includes the use of topical~     microbicides and orally administered anti-HIV drugs. The purpose of this study is to better~     understand the impact of microbicides in women who are diagnosed with HIV-1 during~     participation in previous microbicide trials.~   "
232414|NCT00514085|"~     RATIONALE: Interleukin-21 may stimulate white blood cells, including natural killer cells, to~     kill melanoma cells.~      PURPOSE: This phase II trial is studying the side effects and how well interleukin-21 works~     in treating patients with metastatic or recurrent malignant melanoma.~   "
232415|NCT00514072|"~     RATIONALE: Vaccines made from tumor cells may help the body build an effective immune~     response to kill tumor cells.~      PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works~     compared with a placebo in treating patients with stage D0 prostate cancer.~   "
232430|NCT00513877|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works~     in treating patients with malignant pleural mesothelioma.~   "
232416|NCT00514059|"~     An open clinical trial to study the immune response and safety after giving a booster dose~     (5th Dose) of a combination vaccine against Diphteria-Tetanus-Pertussis-Polio to healthy~     adolescents 15-16 Years of age. The first three doses were given during the first year of~     life, according to the Norwegian child immunization program. The fourth dose was given in a~     previous clinical trial performed in 1998 when the children were 6-7 years old.~      In 2006 there was a change in the child immunization program in Norway: a fourth dose of a~     Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio is given to children 6-7 years~     old.~      This study will give us information if there is need for an additional dose (5th dose) of a~     combination vaccine, containing the pertussis components, before the adolescents are leaving~     secondary school.~   "
232417|NCT00514046|"~     Background:~        -  Medullary thyroid carcinoma (MTC) is common in people with a genetic disorder called~          multiple endocrine neoplasia (MEN).~        -  Vandetanib is an experimental drug that blocks a defective protein receptor (RET~          receptor) found on the surface of cancer cells in people with MEN. It is thought that~          this protein is a primary cause of MTC in people with MEN.~      Objectives:~        -  To study the activity of Vandetanib in children and adolescents with MEN-related MTC by~          measuring the change in tumor size, in blood levels of proteins produced the tumor~          (calcitonin and CEA) and in tumor-related diarrhea.~        -  To determine the safety and tolerability of Vandetanib in children and adolescents.~        -  To study how the body handles Vandetanib in children and adolescents.~        -  To determine the effect of Vandetanib on the survival of children and adolescents with~          MTC.~      Eligibility:~      -Children and adolescents 5 to 18 years of age with MTC whose tumor cannot be surgically~     removed or has grown back after treatment or has metastasized (spread beyond the thyroid~     gland).~      Design:~        -  Patients take Vandetanib once a day in 28-day cycles. The first patients enrolled in the~          study are started on a low dose of Vandetanib to determine tolerability.~        -  Patients have periodic blood tests, electrocardiograms, and blood pressure measurements~          to look for side effects of Vandetanib.~        -  Blood tests and imaging scans (MRI, CT, bone and octreoscan) are done every 8 weeks for~          the first 32 weeks of treatment and then every 16 weeks for the duration of the~          treatment period.~        -  Patients who have tumor-related diarrhea keep a daily record of the number and~          consistency of bowel movements.~   "
232418|NCT00514033|"~     Following licensing of PoliorixTM in Korea, this study will collect safety data about the~     routine use of this vaccine in 600 children according to the regulations of Korean Food and~     Drugs Administration (KFDA).~   "
232419|NCT00514020|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving fluorouracil together with~     oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or~     gastroesophageal junction cancer.~   "
232420|NCT00514007|"~     Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum~     Tolerated Dose (MTD) on both Once Daily (QD) and Twice Daily (BID) schedules.~   "
232421|NCT00513994|"~     The purpose of the study is to measure how much nitroglycerin or its metabolites may be found~     in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied~     to the skin of healthy subjects.~   "
232422|NCT00513981|"~     RATIONALE: Drugs used in chemotherapy, such as high-dose methotrexate work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Chemoprotective drugs, such as leucovorin calcium, may protect normal cells from~     the side effects of chemotherapy.~      PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of~     high-dose methotrexate in treating patients with solid tumors.~   "
232423|NCT00513968|"~     This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110)~     combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B~     infection.~   "
232424|NCT00513955|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,~     and prednisolone, work in different ways to stop the growth of cancer cells, either by~     killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy~     together with bortezomib may kill more cancer cells. It is not yet known whether combination~     chemotherapy is more effective with or without bortezomib in treating mantle cell lymphoma.~      PURPOSE: This randomized phase II trial is studying combination chemotherapy and bortezomib~     to see how well they work compared with combination chemotherapy alone in treating patients~     with relapsed or refractory mantle cell lymphoma. Combination chemotherapy alone (Arm I) has~     been discontinued April 2012 on recommendation of the DMC.~   "
232425|NCT00513942|"~     The aim is to test effects of using formal kick counting chart in the third trimester of~     pregnancy in an unselected population. The research questions are:~      Does Fetal Movement Counting (FMC):~        1. Improve the identification of risk pregnancies/pathology?~        2. Affect the women's well-being?~        3. Stimulate maternal-fetal attachment antepartum?~   "
232426|NCT00513929|"~     The propose of this study is to evaluate if zinc given as an adjunct to standard treatment of~     severe pneumonia in young children shortens the duration and reduces treatment failure, and~     if these effects are pathogen-dependant.~   "
232427|NCT00513916|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Eating a~     diet high in isoflavones, compounds found in soy foods, may keep cancer from forming.~      PURPOSE: This randomized phase III trial is studying the effects of dietary soy on estrogens~     in breast fluid, blood, and urine samples from healthy women.~   "
232428|NCT00513903|"~     This study will test whether enhanced continuity of pharmacy care that includes increased~     communication between inpatient and outpatient settings will improve the appropriateness of~     medication therapy and reduce the number of serious adverse drug events, hospitalizations and~     unscheduled office visits in vulnerable patients with cardiovascular disease, pulmonary~     disease or diabetes.~   "
232429|NCT00513890|"~     The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric~     an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton,~     England]) during bronchiolitis of the infant compared to a conventional managment.~   "
232433|NCT00513825|"~     Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients~     undergoing diagnostic or interventional procedures requiring radiographic contrast agents.~     Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline( the~     uniformly accepted prophylaxy) in preventing RCIN.But most studies have excluded patients~     with history of pulmonary edema, severe heart failure(NYHA 3-4), uncontrolled hypertension or~     ejection fraction less than 30%. Therefore the aim of this study is to evaluate the efficacy~     of sodium bicarbonate solved in half saline compared with infusion of half saline in~     prevention of RCIN in these groups of patients.~   "
232434|NCT00513799|"~     The purpose of this study is to determine the natural history of community-associated~     Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate~     of recurrent infections in those colonized with S. aureus.~      In addition, this study will evaluate the efficiency of commonly prescribed decolonization~     measures in patients presenting with S. aureus skin and soft tissue infections.~   "
232435|NCT00513786|"~     Purpose of this study is to determine the effectiveness of the drug combination carboplatin,~     paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.~   "
232436|NCT00513773|"~     The purpose of this study is to better understand the role of inflammation in the~     pathophysiology of abdominal aortic aneurysm. In this study we hope to show better ways of~     predicting risk in this condition by using a combination of FDG-PET with CT.~   "
232437|NCT00513760|"~     Leukotriene receptor antagonists (LTRAs) are frequently prescribed to reduce the symptoms~     associated with asthma. Singulair, manufactured by Merck, is a popular LTRA, however its~     effectiveness varies greatly between individuals. We are interested in understanding why the~     effectiveness of Singulair varies so greatly.~      For an oral drug such as Singulair to be effective, the body must efficiently absorb it. We~     have found that blood levels of Singulair vary greatly between individuals, and we think that~     this variability is responsible for variability in response.~      Drug absorption occurs primarily in the intestine. Due to differences in the chemical~     properties of drugs, some drugs can be absorbed easily while other drugs require help from~     special proteins produced by the cells that line the intestine. These proteins, or~     transporters act like turnstiles to allow drugs to move from the intestine to the bloodstream~     and are known to be inhibited by components of citrus juice. The activity of a transporter~     can be influenced by individual genetic variability.~      We think that Singulair requires help from a transport protein to be absorbed and that~     genetic variability in this transporter leads to variability in the blood level of Singulair.~     In this proposal we will use citrus juice (grapefruit and orange) to inhibit intestinal~     membrane transport proteins and show that Singulair requires these transporters to be~     efficiently absorbed. Eventually, what we learn from this work will allow doctors to quickly~     test individuals with asthma to determine how well they will absorb Singulair and possibly~     other LTRAs. Knowing this will allow the doctor to adjust the drug treatment on an individual~     basis to maximize benefit in the treatment of asthma.~   "
232438|NCT00513747|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Giving fludarabine together with rituximab~     may kill more cancer cells. Sometimes the cancer may not need treatment until it progresses.~     In this case, observation may be sufficient. It is not yet known whether giving fludarabine~     together with rituximab early is more effective than giving fludarabine and rituximab after~     observation in treating chronic lymphocytic leukemia.~      PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how~     well they work when given early or after observation in treating patients with previously~     untreated chronic lymphocytic leukemia.~   "
232439|NCT00513734|"~     Corneal damage in critically ill patients is common. There are currently two popular methods~     of treatment in the UK; hydrogel dressings and lubricating ointment. We propose to randomise~     patients to have a different treatment for each eye and see which one is more effective.~   "
232440|NCT00513721|"~     This is a review of prostate biopsy specimens which show capsular penetration or positive~     surgical margins. Patients had surgery performed at William Beaumont Hospital-Royal Oak,~     Michigan.~   "
232441|NCT00513708|"~     The purpose of this study is to determine whether peer visits (known as 12th Step Calls)~     and professional counselors (using Motivational Enhancement Therapy) are effective helping~     alcoholics link to substance abuse treatment programs after being in the hospital for detox.~   "
232442|NCT00513695|"~     This phase II trial studies how well giving sunitinib malate together with paclitaxel,~     doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients~     with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.~     Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving sunitinib malate together with~     combination chemotherapy before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed~   "
232443|NCT00513682|"~     This is a Phase III, multicenter, open-label study, that will evaluate the improvement of~     nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by~     Aptalis (formerly Axcan). This study is performed in children from 7 to 11 years old.~   "
232444|NCT00513669|"~     This is a phase Ib double-blind randomized placebo controlled age-deescalating trial to~     assess sagety and immunogenicity of two virosome formulated anti-malaria vaccine components~     (PEV 301 and PEV 302) administered in combination to healthy semi-immune Tanzanian adult and~     children.~   "
232445|NCT00513656|"~     The purpose of this study is to test the oxycodone/naloxone combination compared to oxycodone~     alone in patient's specific type of chronic cancer pain.~   "
232446|NCT00513643|"~     The metabolic effect of three different doses of insulin aspart and human insulin are~     investigated with the euglycaemic glucose clamp technique.~   "
247508|NCT00313313|"~     The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe~     and works better than increasing the amount of sulfonylurea a patient takes~   "
232447|NCT00513630|"~     The purpose of this study is to explore the recurrence risk of cardiovascular events in~     patients with type 2 diabetes mellitus and coronary heart disease after different~     antidiabetic drug therapy (glipizide or metformin) by using an double-blind, randomized,~     parallel control and prospective study~      The end point of this study is:~        1. follow up 3yr~        2. recurrence of cardiovascular event~        3. death caused by other reasons such as stroke, uremia, blindness and amputation~   "
232448|NCT00513617|"~     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited genetic disease~     that can cause intense pain episodes. This study will evaluate the effectiveness of the~     nutritional supplement arginine at improving blood cell function and disease symptoms in~     people with SCD.~   "
232449|NCT00513604|"~     Background:~        -  Most therapeutic therapies for metastatic melanoma have focused on the ability of T-cell~          lymphocytes to kill cells of tumors.~        -  An adaptive cell transfer therapy has been pioneered, in which cells are grown for a~          short time in the laboratory. The way they are grown may have a better effect in a~          patient's body than do other cells that are cultured for a longer time.~      Objectives:~        -  To determine whether tumor-infiltrating lymphocytes (TIL) can be put in cells removed~          from patients' tumors or blood and then reinfused, with the purpose of shrinking tumors.~        -  To evaluate safety and effectiveness of the treatment.~      Eligibility:~        -  Patients 18 years of age or older with metastatic cancer melanoma (cancer that has~          spread beyond the original site).~        -  Patient's leukocyte antigen type is human leukocyte antigens (HLA-A) 0201.~      Design:~      -Patients undergo the following procedures:~        -  Leukapheresis (on two occasions). This is a method of collecting large numbers of white~          blood cells. The cells obtained in the first leukapheresis procedure are grown in the~          laboratory, and the TIL cells (called young TIL cells) are inserted into the cells using~          an inactivated (harmless) virus in a process called retroviral transduction. Cells~          collected in the second leukapheresis procedure are used to evaluate the effectiveness~          of the study treatment.~        -  Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1~          hour for 2 days to suppress the immune system so that the patient's immune cells do not~          interfere with the treatment.~        -  Treatment with young TIL cells. Patients receive an IV infusion of the treated cells,~          followed by infusions the drug aldesleukin-2 (IL-2), which helps boost the effectiveness~          of the treated white cells.~        -  Patients are given support medications to prevent complications such as infections.~        -  Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue).~        -  Patients are evaluated with laboratory tests and imaging tests, such as computed~          tomography (CT) scans, 4 to 6 weeks after treatment and then once a month for 3 to 4~          months to determine the response to treatment.~        -  Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.~   "
232450|NCT00513591|"~     It is difficult to predict how a women with an autoimmune disease will do during pregnancy.~     Some women will improve, others will worsen. Some pregnancies progress normally and others~     become very complicated.~      The Duke Autoimmunity in Pregnancy (DAP) Registry will enroll women with autoimmune diseases,~     such as lupus, rheumatoid arthritis, scleroderma, and Sjogren's syndrome who wish to become,~     or already are, pregnant. We will follow these women throughout pregnancy to better~     understand how their autoimmune disease affects their pregnancy, and vice versa.~   "
232451|NCT00513578|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of~     white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine~     therapy together with GM-CSF may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF~     works in treating patients with low-risk or intermediate-risk myelodysplastic syndrome.~   "
232452|NCT00513565|"~     This study will be conducted in healthy volunteers to investigate the effect of single dose~     GSK561679 on the changes of brain activation, as it compares to an active comparator,~     lorazepam.~   "
232453|NCT00513552|"~     Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract. The origin~     of Crohn's disease remains unknown and there is no curative therapy, either medical or~     surgical, for this gut disorder.~      It is believed that an infectious agent is important in the development of Crohn's disease.~     The similarity of Crohn's disease to the animal form of ileitis, termed Johne's disease,~     supports the possibility that both disorders are caused by exposure to Mycobacterium avium~     paratuberculosis or MAP. Multiple investigators have demonstrated good clinical responses of~     patients with Crohn's disease to treatment with triple antibiotic therapy directed against~     mycobacterial infection.~      The hypothesis of this protocol is that triple antibiotic therapy is useful as a medical~     therapy for patients with Crohn's disease. The aim of this study is to examine the response~     of patients with Crohn's disease who are not receiving therapy with biological agents to~     triple antibiotic therapy.~   "
232454|NCT00513539|"~     RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked~     area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by~     tumor cells. The drug becomes active when it is exposed to light. When the drug is active,~     tumor cells are killed. It is not yet known whether biliary stenting is more effective with~     or without photodynamic therapy in treating patients with biliary tract tumors.~      PURPOSE: This randomized phase III trial is studying biliary stenting to see how well it~     works compared with biliary stenting and photodynamic therapy using porfimer sodium in~     treating patients with locally advanced, recurrent, or metastatic cholangiocarcinoma or other~     biliary tract tumors that cannot be removed by surgery.~   "
232455|NCT00513526|"~     RATIONALE: Vaccines made from human papillomavirus may help the body build an effective~     immune response to kill HIV cells.~      PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus~     vaccine therapy works in treating men with HIV-1 infection.~   "
232456|NCT00513513|"~     This is an open label study (no placebos are used; all patients will receive the true~     medication) to evaluate the effectiveness of TMC114/rtv in treatment naÃ-ve (never previously~     received anti-HIV drugs), HIV 1 infected patients.~   "
232457|NCT00513500|"~     The purpose of the study is to demonstrate the effectiveness and feasibility of~     community-based management of pneumonia and malaria by community health workers (CHWs) in a~     rural district of Zambia.~   "
232458|NCT00513487|"~     This study will evaluate whether multiple nasal antigen challenges with dust mite allergen~     produces increases in nasal symptoms and local allergic inflammatory cells in the nose and~     the blood.~   "
232459|NCT00513474|"~     RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by~     a donor stem cell transplant.~      PURPOSE: This clinical trial is studying how well rasburicase works in preventing~     graft-versus-host disease in patients with hematologic cancer or other disease undergoing~     donor stem cell transplant.~   "
232460|NCT00513461|"~     This randomized phase II trial studies how well S-Adenosyl-L-Methionine Disulphate~     P-Toluene-Sulfonate (SAMe) works compared to a placebo in preventing liver cancer in patients~     with chronic hepatitis C infection. Chemoprevention is the use of certain drugs to keep~     cancer from forming. The use of SAMe may keep cancer from forming in patients with advanced~     liver disease~   "
232462|NCT00513435|"~     This phase II trial is studying the how well saracatinib works in treating patients with~     metastatic or recurrent head and neck cancer. Saracatinib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth~   "
232463|NCT00513422|"~     The primary aim of this study is to determine if the dietary supplements, glucosamine~     sulphate and/or chondroitin can limit or reduce structural disease progression whilst~     providing symptomatic benefit in people with osteoarthritis (OA) of the knee.~      The specific hypotheses to be tested in the proposed double blind, placebo-controlled,~     randomised clinical trial are that, compared to participants allocated to placebo,~     participants allocated to either or both of these dietary supplements will demonstrate:~        -  reduced medial tibio-femoral joint space narrowing at 2 years AND;~        -  reduced knee pain over 1 year~      These benefits will be achieved by participants allocated to glucosamine sulphate and/or~     chondroitin (the study treatments) without concomitant:~        -  increased use of analgesics~        -  reduced health-related quality of life~        -  reduced participation in leisure-time physical activity~   "
232464|NCT00513409|"~     This is a booster study in 2 groups of healthy children less than 3 years old to measure the~     reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine,~     when given as a booster or as a two-dose catch-up vaccination.~      This protocol posting deals with objectives and outcome measures of the booster phase. The~     objectives and outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00338351).~   "
232465|NCT00513396|"~     The need for a standardized treatment protocol for multidrug resistant tuberculosis (MDR-TB)~     in resource-limited countries is being increasingly recognized. This single center, double~     blind, randomized controlled trial was designed to compare the time required for sputum~     culture conversion and extent of radiological improvement in cases of MDR pulmonary~     tuberculosis when isoniazid was included (both at a regular dose and at a high dose) as an~     adjuvant to the standardized second line of treatment. The study was designed to test the~     hypothesis that inclusion of high-dose isoniazid will enhance the effectiveness of the second~     line of treatment in cases of MDR-TB without significantly increasing the toxicity.~   "
232466|NCT00513383|"~     This study is being done to test whether panitumumab, in combination with chemotherapy and~     radiation is safe in people with head and neck cancer. Another goal of this study is to find~     the highest dose of the study drugs that can be given safely without causing serious sife~     effects. Panitumumab is a type of drug called a monoclonal antibody that has been studied in~     other types of cancers, such as kidney and colon. This monoclonal antibody is directed~     against the epidermal growth factor receptor (EGFR). EGFR has been found on the majority of~     head and neck cancer cells. By blocking EGFR, this monoclonal antibody may inhibit the growth~     of head and neck cancer cells.~   "
232467|NCT00513370|"~     To evaluate the safety profile, the effectiveness and the economic impact of adalimumab when~     used for the treatment of subjects with active plaque psoriasis who have not adequately~     responded to prior psoriasis therapy.~   "
232468|NCT00513357|"~     The goal of this clinical research study is to evaluate the effectiveness of melatonin for~     the management of poor appetite and weight loss in advanced cancer patients. The~     effectiveness of melatonin on weight gain, keeping/gaining of lean muscle mass, improved~     appetite, and side effects will also be evaluated.~   "
232469|NCT00513344|"~     Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised~     that the bioavailability and therefore probably the bioefficacy of epicatechin from milk~     chocolate was reduced compared to dark. This study is designed to compare milk and dark~     chocolate as a source of polyphenols with a control chocolate for improving a risk~     biomarker for vascular disease.~   "
232470|NCT00513331|"~     This is a study of Barrett's Esophagus (BE) and Gastroesophageal Reflux Disease (GERD). It~     aims to look at the long term efficacy of evidence-based cutting edge diagnostic and~     therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal~     resection and surveillance endoscopy with biopsy. Additionally, biological analyses will be~     performed in hopes of identifying biomarkers associated with the progression of BE to~     esophageal cancer.~   "
232471|NCT00513318|"~     This is a pilot study designed to evaluate the safety and feasibility of performing umbilical~     cord blood transplants in older adults or younger infirm patients with high-risk~     hematopoeitic malignancies. A novel reduced-intensity preparative regimen for umbilical cord~     blood transplantation will be used. One to a maximum of three cord blood units, depending on~     cell count, will be administered to facilitate engraftment. Ten patients will be enrolled~     with an expected accrual rate of 3-4 patients per year and with a goal of completing accrual~     within 2-3 years.~   "
232472|NCT00513305|"~     The primary objective of this study is to determine whether low-dose cytarabine in~     combination with arsenic trioxide is more effective than low-dose cytarabine alone in~     achieving complete remission in elderly patients (≥60 years of age) with acute myeloid~     leukemia.~   "
232473|NCT00513292|"~     This randomized phase III trial is studying giving fluorouracil together with epirubicin and~     cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared~     with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin,~     cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be~     removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. It is not yet known whether it is more effective to~     give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.~   "
232474|NCT00513279|"~     GSK618334 is being developed as an innovative treatment for substance dependence and~     potentially other compulsive behavioral disorders. This study will evaluate the safety,~     tolerability and pharmacokinetics of single doses of GSK618334 in healthy volunteers.~   "
232528|NCT00512551|"~     The goal of this clinical research study is to find out if the expression of certain genes is~     linked with the response of cervical cancer to radiation. Researchers will study a large~     number of genes located in tumor material to learn this information.~   "
247509|NCT00313300|"~     The purpose of this clinical research study is to determine whether apixaban will be safe in~     people who have recently had unstable angina or a heart attack.~   "
232475|NCT00513266|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, fluorouracil and~     leucovorin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. Giving combination chemotherapy together with monoclonal antibody therapy may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with monoclonal antibody therapy works in treating patients with advanced colorectal cancer~     with liver metastases or lung metastases that are potentially removable by surgery.~   "
232476|NCT00513253|"~     This study is designed to estimate the relative bioavailability of alternative lapatinib oral~     formulations compared to the current tablet formulation.~   "
232477|NCT00513240|"~     Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on~     neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long~     term development problems such as learning disorders and hyperactivity syndromes. This study~     aims to determine if erythropoetin, a natural hormone made in the body, protects the brain~     from damage when given in high doses before and during neonatal open heart surgery. We will~     use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental~     outcome testing to see if erythropoetin is better than salt water injection (placebo) in~     protecting the brain.~   "
232478|NCT00513214|"~     The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of XOMA 052 in~     subjects with stable Type 2 Diabetes Mellitus (T2D).~      The study is a dose-escalation study designed to evaluate route of administration~     (intravenous or subcutaneous), doses, and dosing regimens for future studies.~   "
232479|NCT00513201|"~     OBJECTIVE: To compare lispro insulin and regular insulin in the glycemic control of patients~     with liver cirrhosis and type 2 diabetes subjects. METHODS: 108 patients with liver cirrhosis~     and type 2 diabetes were randomly treated with regular insulin or lispro. After 122 weeks a~     cross-over was carried out and patients followed-up for 122 weeks. Then, all patients~     received a standard breakfast of 145 kcal following 12 U.I. of regular insulin or lispro, and~     C-peptide and insulin serum levels were determined over 300 minutes.~   "
232480|NCT00513188|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Combinations of~     biological substances in denileukin diftitox may be able to carry cancer-killing substances~     directly to non-Hodgkin lymphoma cells. Giving combination chemotherapy together with~     denileukin diftitox may kill more cancer cells.~      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together~     with denileukin diftitox works in treating patients with newly diagnosed T-cell non-Hodgkin~     lymphoma.~   "
232481|NCT00513175|"~     The primary objective of this study is to examine transplant related mortality (TRM) at 100~     days <30%. A TRM of >50% is considered unacceptable. This study also seeks a TRM at 12 months~     that is <50%, engraftment >90% (defined as donor cells >80% at 6 months), and 1 year overall~     survival >50%.~   "
232482|NCT00513162|"~     Primary Objective:~        -  Determine the interindividual range and median of individual maximum tolerated doses of~          valproic acid administered as one time evening dose in conjunction with a dose oral~          etoposide (50 mg/m2/day for children, but only 25mg/m2/day for adults to start) for four~          different age groups.~      Secondary Objectives:~        -  Determine the qualitative and quantitative toxicity and reversibility of toxicity of~          valproic acid in conjunction with oral etoposide,~        -  To investigate the clinical pharmacokinetics of valproic acid when given in conjunction~          with oral etoposide,~        -  To describe quality of life of patients with relapsed, or progressive central and~          peripheral nervous system tumors when treated with oral valproic acid and etoposide,~        -  To observe and describe the response pattern of progressive central nervous system~          tumors treated with oral valproic acid and etoposide,~        -  To observe and describe event free survival time and overall survival time of patients~          with relapsed, or progressive central nervous system tumors when treated with oral~          valproic acid and etoposide,~        -  To determine if histone deacetylase activity and topoisomerase expression in lymphocytes~          of patients is related to valproic acid levels, and~        -  To determine, if the individual maximal tolerated dose (iMTD) depends on the initial~          performance status of the patient in the beginning of the treatment.~   "
232483|NCT00513149|"~     Background—Despite the pivotal pathogenic role of platelets in atherothrombosis has been~     widely recognized, there is a striking lack of consensus regarding how to measure platelet~     function and how to monitor the effects of various antiplatelet drugs. In view of the fact~     that recurrent ischemic events occurred in 8.5% to 8.8% of patients treated with dual~     antiplatelet drugs and there is significant inter-individual variability in platelet~     reactivity, we believe that the importance of platelet function assessment and its clinical~     implication should not be overlooked.~   "
232484|NCT00513136|"~     Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering~     months to years after adjuvant therapy is completed. Although researchers have developed some~     effective interventions (exercise or group-based holistic program) to treat fatigue, none~     have addressed the role of the family in the patient's long-term recovery.~      The investigators hypothesize that a family-focused intervention in combination with a~     mind-body group intervention will be more effective in reducing fatigue, improving quality of~     life, and enhancing family relationships for breast cancer survivors than a group~     intervention with an individual focus.~   "
232485|NCT00513123|"~     The overall objective of this study is to identify potential improvements for a noninvasive~     method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for~     colposcopy for fluorescence spectroscopy.~      Other Objectives:~        -  To measure digital fluorescence and reflectance images in vivo of sites in the human~          cervix.~        -  To evaluate the effect of acetic acid in the image contrast obtained.~        -  Compare the device performance to colposcopy and pathologic analysis of tissue removed~          at colposcopy.~   "
232529|NCT00512538|"~     The purpose of this study is to determine the ability of Apligraf to improve the time to and~     incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot~     ulcers treated with standard therapy.~   "
232486|NCT00513110|"~     The adenosine receptor is known for its anti-inflammatory actions and could therefore be a~     potential target in the treatment of sepsis and septic shock. Stimulation of the adenosine~     receptor could potentially lead to a decrease in inflammation and tissue damage.~      Under normal conditions adenosine is formed either by an intracellular 5`nucleotidase, which~     dephosphorylates AMP, or by the hydrolysis of S-adenosylhomcysteine by hydrolase. An~     alternative pathway of AMP degradations is provided by the cytosolic enzyme AMP deaminase~     (AMPD), which catalyses the irreversible deamination of AMP to inosine monophosphate and~     ammonia.~      In humans four AMPD isoforms have been described, named after the source from which they were~     initially purified; M (muscle), L (liver), E1 and E2 (erythrocyte), encoded by AMPD1, AMPD2~     and AMPD3. Approximately 15-20% of Caucasian and African American individuals are~     heterozygous or homozygous for the 34C>T variant of AMPD1.~      We hypothesize that healthy volunteers who have the polymorphism for AMPD1 have a less severe~     inflammatory response to LPS and show less (severe) organ failure. This hypothesis is based~     on the expected higher levels of adenosine in patients with the AMPD1 polymorphism. This~     hypothesis is strengthened by the fact that patients with coronary artery disease and the~     AMPD1 polymorphism show improved cardiovascular survival (Anderson JL et al. J Am Coll~     Cardiol 2000; 36: 1248-52) possibly based on higher adenosine levels by reduced AMPD~     activity. Furthermore the polymorphism predicts improved clinical outcome in patients with~     heart failure (Loh E et al. Circulation 1999) also based on a hypothetical elevation of~     adenosine.~      We hypothesize that:~      The C34T-polymorphism of the enzyme AMP-deaminase leads to a decreased inflammatory respons~     and thereby a decrease of LPS-induced tissue damage.~      A second hypothesis is based on the antagonism of the adenosine receptor, by caffeine;~      Antagonism of the adenosine receptor by caffeine leads to an increased LPS-induced~     inflammatory reaction and an increase in (subclinical) tissue damage?~   "
232487|NCT00513097|"~     Primary, secondary, and tertiary specific aims are to answer the following questions about~     interactive, Internet-based tobacco control intervention directed towards 10th-graders:~        1. Smoking Prevention (primary): Does the intervention result in a lower incidence of~          smoking initiation compared to standard care?~        2. Smoking Cessation (primary): Does the intervention result in higher rates of smoking~          cessation compared to standard care?~        3. Reduction of Spit Tobacco Use (secondary): Does the intervention have an impact on spit~          tobacco use compared to standard care?~        4. Stages of Change (tertiary): Does the intervention have an impact on progression through~          the stages of smoking and spit tobacco acquisition and cessation compared to standard~          care?~        5. Mediating Variables (tertiary): How are mediating variables associated with tobacco-use~          onset and cessation?~        6. Testing Predictors: Investigate established and recently elucidated predictors of~          susceptibility to smoking at baseline and 12-month follow-up.~        7. Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit~          tobacco use at baseline and 12-month follow-up~        8. Testing Measures Across Race/Ethnicity: Explore predictors of susceptibility to smoking~          at baseline and 12-month follow-up to determine whether predictors differ among White,~          African-American, and Hispanic students.~   "
232488|NCT00513084|"~     The primary objectives of this randomized clinical trial are a) to implement and test the~     impact of a 1-year lifestyle obesity treatment program based on Self-Determination Theory on~     3-year change in physical activity and motivation for exercise/physical activity, body weight~     and fat, and selected eating variables, b) to identify behavioral and psychosocial~     theory-based moderators or mediators of primary outcomes, especially physical activity and~     body weight.~   "
232489|NCT00513071|"~     This phase II trial is studying how well AZD0530 works in treating patients with prostate~     cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth~   "
232490|NCT00513058|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and~     vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast~     cancer.~   "
232491|NCT00513045|"~     The objective of this study is to validate a newly designed self-help treatment for~     nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment~     will be validated in comparison to an exposure treatment a diary condition and a waiting list~     condition.~   "
232492|NCT00513032|"~     We hypothesized that pre-treatment with methylene blue could potentiate the effects of~     general anaesthetic agents in patients undergoing parathyroidectomy~   "
232493|NCT00513019|"~     The goal of the proposed study is to evaluate the comparative efficacy of Lamictal~     (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation~     will receive 12 weeks of double-blind treatment with Lamictal (lamotrigine) or matching~     placebo. The hypothesis to be tested is that Lamictal (lamotrigine) will be more effective~     than placebo in patients with neurotic excoriation. The proposed study will provide needed~     data on the treatment of a disabling disorder that currently lacks a clearly effective~     treatment.~   "
232494|NCT00512993|"~     The purpose of this study is to determine the event-free survival (EFS) after zoledronic acid~     for 5 years versus no postoperative treatment in patients with chemo-insensitive breast~     cancer (ypT1-4 and/or ypN1-3) after preoperative anthracycline/taxane containing chemotherapy~   "
232495|NCT00512980|"~     A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in~     patients with intermediate stage Hodgkin's lymphoma~   "
232496|NCT00512967|"~     Reactive oxygen species (ROS) are suggested to play a pivotal role in ILD. Little is known,~     however, about the endogenous antioxidant levels in ILD that can offer protection against~     ROS. It is expected that the high amount of ROS present in ILD will reduce the antioxidant~     levels. Therefore, antioxidant therapy to strengthen this reduced antioxidant defense might~     be efficacious in ILD treatment. Since ROS are capable of initiating and mediating~     inflammation, antioxidant therapy might also mitigate elevated inflammation. A candidate for~     antioxidant therapy is the flavonoid quercetin that is known for its anti-oxidative and~     anti-inflammatory capacities.~      The aim of the present study is to determine the antioxidant and inflammatory status in ILD,~     i.e. sarcoidosis and idiopathic pulmonary fibrosis (IPF). Furthermore, to evaluate the~     possible anti-inflammatory effects of antioxidants, the effect of quercetin will be examined~     on the ex vivo LPS-induced cytokine production in ILD~   "
232530|NCT00512525|"~     Ghrelin administration increases appetite and, in rodents, induces weight gain. The aim of~     this study is to investigate the effect of short term ghrelin administration to humans on~     metabolism.~   "
232531|NCT00512512|"~     This research is being done to evaluate the ability to obtain a liver sample using upper~     endoscopy rather than through a laparoscopic procedure. The investigators hypothesize that~     the endoscopic transoral route is as effective as the laparoscopic route.~   "
232497|NCT00512954|"~     Diseases of the airways (bronchi) of the lungs include asthma and chronic obstructive~     pulmonary disease (COPD), which are leading causes of reduced quality of life, loss of work,~     hospital admissions and deaths and result in a major economic burden to the patient and~     society. Worsening (exacerbation) of these conditions is common and is frequently due to~     viral or bacterial infection, which causes inflammation in the bronchi, i.e. bronchitis. Ways~     to objectively measure the inflammation are needed to improve diagnosis, cause and severity~     and to guide treatment. The investigators also need to understand changes in the body's~     defense (immune) mechanisms that make some patients have more frequent infective bronchitis.~      At present, sputum cell counts are able to identify different types of bronchitis, their~     severity and may be able to differentiate viral from bacterial infection. Other measurements~     in sputum, exhaled breath, blood and urine are also available to measure this inflammation.~     Measurement of immune cells in the blood gives us an idea about the working capacity of the~     immune system of the body.~      The investigators plan to study patients with asthma or COPD at the time of worsening of~     their condition to identify,~        1. To what extent viral or bacterial bronchitis can be diagnosed from tests of~          inflammation?~        2. How clearing of infection relates to clearing of inflammation?~        3. What are the changes in the body's defense mechanisms that make a patient more prone to~          frequent infective bronchitis?~        4. How do the measurements in sputum, exhaled breath, blood and urine relate to viral and~          bacterial bronchitis?~        5. What are the differences in the measurements in sputum, exhaled breath, blood and urine~          in asthma and COPD?~   "
232498|NCT00512941|"~     Chronic hepatitis by the B virus (HBV) and/or by the C virus (HCV) is a major public-health~     problem since it presents a long phase of clinical latency which makes its early diagnosis~     difficult and results in the development of a large number of cases to complications such as~     cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated that the~     number of HBV is two million, of which 72 thousand have been reported. As regards HCV, the~     ratio is one of three million estimated cases to 52 thousand reports. Learning about the~     serological profile of the users of a viral hepatitis reference service is fundamental for~     the planning of diagnostic and caregiving actions; therefore, it is the objective of this~     study.~   "
232499|NCT00512928|"~     Oral anticoagulants that are widely used for the treatment of thrombo-embolic disease exert~     their effect by blocking the recycling of vitamin K. Vitamin K acts as a co-factor in the~     posttranslational carboxylation of vitamin K-dependent proteins such as osteocalcin and~     matrix-gla protein. It is important to quantify the dose-response relationship of the~     interaction between vitamin K and oral anticoagulants and to investigate at what dosage~     vitamin K will interfere with oral anticoagulants in a clinically relevant way.~   "
232500|NCT00512915|"~     The purpose of this study is to evaluate the possibility to program the shortest possible~     Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting~     inappropriate Mode Switch due to Far Field R-Wave sensing when using the new Tendril 1699T~     lead. Comparison with Tendril 1688T or 1388T with optimized Post Ventricular Atrial Blanking~     (PVAB).~   "
232501|NCT00512902|"~     The purpose of this study is to assess the safety and tolerability of imatinib (gleevec) in~     subjects who have systemic sclerosis. Imatinib has been approved by the FDA for the treatment~     of newly diagnosed adult patients with CML (newly diagnosed adult patients and for the~     treatment of patients with an accelerated phase. Imatinib is also approved for the treatment~     of patients with a certain type of gastrointestinal cancer (called stromal tumors) but it has~     not been approved to treat systemic sclerosis. Imatinib works by interfering with an enzyme~     called tyrosine phosphatase resulting in suppression of the immune system. It als interferes~     with a protein called platelet derived growth factor receptor (PDGFr) that has been linked to~     increased fibrosis.~   "
232502|NCT00512889|"~     RATIONALE: Cytotoxic T lymphocytes (CTL) are cells of the immune system that can fight~     infections and cancer. These CTL can be manipulated in the laboratory so that they can target~     an individual's cancer.~      PURPOSE: This early phase trial is studying the feasibility and side effects of intravenous~     infusions of CTL generated in the laboratory. To produce the CTL, the study participant's own~     immune cells are collected by a procedure called a leukapheresis. The cells then undergo~     laboratory processing for three weeks. Part of this processing includes mixing the patients~     immune cells with a new kind of cell that has some extra genes added to it. These extra genes~     are to teach the participant's own immune cells to become anti-tumor CTL that can attack~     the melanoma.~   "
232503|NCT00512876|"~     Purpose: To determine the efficacy and safety of one commonly used VEGF inhibitor,~     bevacizumab (Avastin, Genentech), as a topical agent for the treatment of corneal~     neovascularization.~   "
232504|NCT00512863|"~     To evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the~     change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of~     refractory asthma.~   "
232505|NCT00512850|"~     RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The~     use of folic acid may prevent colorectal cancer.~      PURPOSE: This randomized clinical trial is studying how well folic acid works compared with a~     placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.~   "
232532|NCT00512499|"~     Osteoporosis is a very frequent and easily treatable disease. Rates of treatment of affected~     patients is very low, as few high risk patients initiate treatment and only a minority of~     those pursue treatment for long enough time to prevent fractures. Patients presenting a~     fragility fracture after 50 years of age are at high risk of osteoporosis and may represent~     the ideal group of patients in which intervention aimed at improving initiation and~     persistence on treatment will be most effective.~      Our first hypothesis is that the availability of a dedicated nurse practitioner to identify~     patients with fragility fractures among patients presenting at fracture clinics of orthopedic~     surgeons will increase markedly the rate of identification of osteoporosis.~      Our second hypothesis is that giving to both the patient and its primary health practitioner~     (PHP) the patient's clinical, biological and radiological data along with individualized care~     suggestions will yield significantly better results than giving to the patient and its PHP~     generic information on osteoporosis risk, investigation and treatment.~   "
232533|NCT00512486|"~     The primary objective of this study is to investigate the safety of administration of this~     drug by increasing doses to male and female adult subjects with mild asthma.~   "
232506|NCT00512837|"~     Although asthma outcomes can be improved with structured care, less than half of people with~     asthma achieve good control. Part of the problem is poor adherence with self-monitoring and~     preventive drug regimes. This trial will test whether using mobile phone-based monitoring, as~     part of a structured care plan, improves clinical outcomes and confidence in people with~     poorly controlled asthma.~      Adults and teenagers with poorly controlled asthma will be recruited and randomly assigned to~     one of two groups. Those in the mobile phone group will monitor their asthma daily using~     their mobile phone to record symptoms, medication and lung function. Instantaneous feedback~     to their phone will provide a visual indication of asthma control and prompts about therapy.~     The patient and their clinician will have web-based access to all readings. People in the~     control group will use traditional paper-based monitoring. Under the care of their asthma~     nurse, both groups will be treated according to the step-wise approach of the BTS/SIGN asthma~     guideline in order to gain control.~      We will use the validated Asthma Control Questionnaire to measure control at baseline, three~     and six months, and compare improvement in the two groups. We will also assess how confident~     people feel in controlling their asthma, using a validated measure of self-efficacy,~     attitudes and knowledge.~      Technological solutions to long-term healthcare problems are increasingly being sought by~     patients, clinicians and policy makers. If successful, our trial could provide timely~     evidence for the use of information technology to address the long-recognised problem of poor~     asthma control.~   "
232507|NCT00512824|"~     This is a long term study on the efficacy of dietary calcium with or without probiotic~     strains in reducing the mean number of episodes and duration of diarrheal disease.~   "
232508|NCT00512811|"~     to assess the efficacy of inhaled furosemide in mustard gas exposed patients with acute~     respiratory failure~   "
232509|NCT00512798|"~     RATIONALE: Drugs used in chemotherapy, temozolomide, work in different ways to stop the~     growth of tumor cells, either by killing the cells or stopping them from dividing. Bortezomib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving temozolomide together with bortezomib may kill more tumor cells.~      PURPOSE: To determine the best dose of bortezomib and temozolomide and to see how well they~     work in treating patients with advanced refractory solid tumors or melanoma.~   "
232510|NCT00512785|"~     The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.~   "
232511|NCT00512772|"~     The purpose of this study is to determine if the use of antibiotic guidelines and thus~     antibiotics can be improved through a description of possible barriers leading to tailored~     interventions.~   "
232512|NCT00512759|"~     The purpose of this study is to determine whether an early goal-directed decrement of preload~     and afterload with a target systolic blood pressure of 90-110 mmHg by aggressive~     vasodilatation in patients with acute HF in the non-ICU setting is safe, and leads to a~     better clinical and economical outcome~   "
232513|NCT00512746|"~     RATIONALE: Screening tests or exams may help doctors find lung cancer sooner, when it may be~     easier to treat.~      PURPOSE: This randomized clinical trial is studying screening tests or exams to see how well~     they work compared to usual care in finding early stage lung cancer in current or past~     smokers with chronic obstructive pulmonary disease.~   "
232514|NCT00512733|"~     Dairy products continue to be an important source of calcium, providing over half the calcium~     intake for most individuals. Educational interventions promoting adequate calcium intake with~     tools estimating dietary calcium that can be easily utilized by consumers would be a valuable~     asset to promoting skeletal health. Validation of these tools against standard dietary~     assessment methods enhances their utility. The Dairy Council of California has developed two~     dietary calcium questionnaires, one electronic and one in print, using known dietary sources~     of calcium including frequency of consumption and portion size. For these questionnaires to~     be effective in clinical and research settings they must be a valid measurement of dietary~     calcium intake. To measure the validity of the dietary calcium questionnaires one hundred~     seventy three women will complete the two dietary calcium questionnaires and one 3-day food~     record. The dietary calcium questionnaires will be validated against this established method~     of dietary intake measurement. The objective of this study is to validate two dietary calcium~     questionnaires that can be used in clinical and research settings against an established~     method of dietary intake measurement. It is hypothesized that both dietary calcium~     questionnaires will be a valid measurement of dietary calcium intake in women.~   "
232515|NCT00512720|"~     To determine the effect of three different percutaneous revascularization strategies (Balloon~     Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower~     extremity claudication~   "
232516|NCT00512707|"~     The purpose of this placebo-controlled study is to determine if testosterone replacement~     therapy, administered by transdermal gel, can improve the response to sildenafil (Viagra R)~     treatment in men who have erectile dysfunction (ED) and low testosterone levels.~   "
232517|NCT00512694|"~     Lupus is a systemic autoimmune disease that can present with many varied symptoms, including~     joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most~     common in younger women.~      The Duke Lupus Registry will collect information and blood samples from patients with lupus~     (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The~     goal of this Registry is to understand how lupus changes over time so that we can improve the~     treatment of patients with lupus.~   "
232518|NCT00512681|"~     Patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1~     and S-1(80mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned~     treatment of maximum 12 cycles of chemotherapy. Response assessement will be performed every~     2 cycles of chemotherapy.~   "
232519|NCT00512668|"~     This phase I trial is studying the side effects and best dose of temsirolimus when given~     together with hormone therapy in treating patients with relapsed prostate cancer. Androgens~     can cause the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by~     lowering the amount of androgens the body makes. Temsirolimus may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving hormone therapy together~     with temsirolimus may kill more tumor cells~   "
232571|NCT00511992|"~     The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with~     intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete~     6 cycles of treatment.~   "
232520|NCT00512655|"~     Background: Approximately 750,000 elderly Dutch people fall at least once a year, which often~     results in physical injuries and a fear of falling, with high costs and far-reaching~     consequences on functionality, physical activity, quality of life and mental well-being.~     Falling is not only a burden for patients, it is also a burden for their caregivers.~     Recurrent falling is a complex problem. However, the pathophysiological background of falls,~     gait problems and dementia is largely unknown. The general pathophysiological hallmark of~     aging is a liability in homeostatic mechanisms of organs. This liability results in an~     impaired ability to adapt to stress and in increased biological variation in outcome measures~     within individuals. In this study the investigators aim at developing an intervention to~     reduce recurrent falling in frail elderly fallers.~      Hypotheses: The investigators hypothesize that the intervention program will decrease the~     number of falls and fear of falling and increase mental well-being, physical activity and~     functional performance in frail elderly people with a history of recurrent falling. In~     addition, the burden on the caregivers will be reduced due to the intervention and will be~     cost-effective. Furthermore, the investigators hypothesize that patients with a high~     short-term intra-individual biological variability in gait and cognition variables have a~     higher risk of falling, worse gait performance and cognitive decline after long term~     follow-up.~      Study Design: Randomized, controlled, single-blind trial.~      Study Population: 160 patients referred to a geriatric outpatient clinic, who fell at least~     once in the last 6 months and their primary caregivers (N=160).~      Intervention: A multifaceted fall prevention program for frail elders to reduce falls~     incidence rate, consisting of physical and cognitive components. Moreover, it includes a~     training program for caregivers in which they learn to support and give advice to the~     patients, aiming to decrease the burden on the caregivers.~      Primary Outcome Measures: The fall incidence rate is the primary outcome measure. Total~     observation time of falls will be 6 months after the start of the intervention.~      Secondary Outcome Measures: In the patients, the secondary outcome measures are fear of~     falling (FES), quality of life (MOS-20), depression and general anxiety, functional~     performance in activities of daily living, physical activity, mobility, gait parameters, body~     sway and biomarkers of endothelial function and frailty. For the caregiver, the secondary~     outcome measures are caregiver's burden, mood and quality of life. In addition,~     intraindividual variability of cognition, balance and gait in both patients and caregivers,~     will be assessed and cost-effectiveness of the intervention will also be determined.~   "
232521|NCT00512642|"~     Despite intensive research efforts, there are still no simple and effective screening tools~     to detect early lung cancer. The majority of newly diagnosed patients have higher stage,~     often disseminated, non-resectable disease. A better understanding of the natural biology and~     molecular abnormalities in early lung lesions may aid in the development of more effective~     screening tools. This study will investigate the effectiveness of bronchoscopy by white light~     (WL) alone and in combination with Lung Imaging Fluorescence Endoscopy (LIFE) for the~     detection of early lung lesions in patients with a high risk for developing lung cancer. LIFE~     is a FDA approved adjunct to WL bronchoscopy for the screening of lung cancer and this study~     will provide a standardized setting in which a direct comparison between a combination of WL~     and LIFE versus traditional WL bronchoscopy can be made.~      In addition, the study will set the stage for the collection of a unique set of biopsy~     specimens that will be used to learn more about the natural biology and the molecular changes~     in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and by~     molecular analyses. The p53 results will be compared with histological grade and with genomic~     instability. Measures for genomic instability will be the loss of chromosomal information and~     cellular aneuploidy. Recent advances in molecular pathology, such as the development of Laser~     Capture Microdissection (LCM), have made the molecular profiling of these extremely small~     lesions feasible. The information obtained by these techniques will be used for comparison~     with clinical and exposure information. Future plans include the culturing of bronchial~     epithelial cells to study genomic instability in the multistep process of cancer progression.~     It is our hope that the application of these new technologies will improve the early~     detection of human lung cancer and provide insight into the natural biology and molecular~     changes of early lung lesions which may progress towards overt cancers.~   "
232522|NCT00512629|"~     Parenteral nutrition (PN) solutions are life saving in patients with surgical~     gastrointestinal diseases. However, the use of PN in pediatric populations, especially~     premature infants, is frequently associated with liver injury that may ultimately result in~     hepatic failure. In studies conducted in a murine model, we observed that intravenous fat~     emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of~     cholestasis, a common precursor of PN-associated liver disease, as well as reverse~     preexisting PNALD through a combination of factors, including improved triglyceride clearance~     coupled with anti-inflammatory properties. In a case series treating patients with hepatic~     cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of~     an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no~     adverse reactions attributed to its use were observed. Based on results of these previous~     studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of~     efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal~     failure~   "
232523|NCT00512616|"~     This study examines if Ceftriaxone, an antibiotic, will improve symptoms of depression in~     Bipolar Disorder.~      Purpose: This study will examine whether the drug ceftriaxone can help patients with bipolar~     depression during short-term treatment of symptoms such as depressed mood, psychomotor~     retardation (slowed down thinking and movements), and problems with sleep. Recent studies~     suggest that abnormalities in the brain levels of the chemical glutamate may be involved in~     causing depression. Ceftriaxone increases a protein in the brain called GLT1, which is~     responsible for regulating brain levels of glutamate.~      People between 18 and 65 years of age with bipolar disorder who are currently in a depressive~     episode of at least 4 weeks but no longer than 12 months duration may be eligible for this~     study.~      Participants are admitted to the NIH Clinical Center for about 10 weeks. During the first 1~     to 2 weeks, they are evaluated and tapered off any antidepressant or mood stabilizers they~     have been taking. They remain free of all medication for 2 weeks and are then randomly~     assigned to take either ceftriaxone or placebo for 6 weeks. The study drugs are given~     intravenously (through a vein) every day. To minimize discomfort, patients are given a PICC~     line - a tube that is inserted in a vein in the arm and remains there for the duration of~     drug treatment. This prevents the need for repeated intravenous injections.~      Patients have a physical examination at the beginning and at the end of the study and two~     electrocardiograms (ECG) during the study. They are evaluated periodically with a series of~     psychiatric rating scales to determine the effects of the study drug on mood and thinking and~     they have periodic blood tests to assess their health status.~      In addition, patients are asked to undergo a lumbar puncture (spinal tap) twice during the~     study to collect a sample of cerebrospinal fluid (CSF, the fluid that bathes the brain and~     spinal cord). The CSF is examined to try to understand how brain chemicals are related to~     depression and to the effects of ceftriaxone. A local anesthetic is given and a needle is~     inserted in the space between the bones in the lower back where the CSF circulates below the~     spinal cord. A small amount of fluid is collected through the needle. This test is optional.~      At the end of the study patients are offered free treatment for up to 3 months with standard~     medications for bipolar depression and a referral to a community physician for long-term~     treatment will be made.~   "
232524|NCT00512603|"~     The association between the levels of d-dimer, fibrinogen and PAI-1 in plasma of elderly~     patients admitted to internal medicine departments because of infection and the occurrence of~     cardio- and cerebro-vascular disease after discharge~   "
232525|NCT00512590|"~     The purpose of this pilot study was to test the effects of a 10-week relaxation and guided~     imagery intervention on pain perception, functional status, self-efficacy and levels of~     distress in Hispanic adults diagnosed with fibromyalgia.~   "
232526|NCT00512577|"~     TAPS is a sequential trial which aims to investigate whether the administration of a blood~     transfusion pre-operatively to patients with sickle cell disease (HB SS or Hb SB0 thal)having~     low or medium risk elective surgery increases or decreases the overall rate of peri-operative~     complications. The proportion of patients with peri-operative complications in two randomised~     groups of transfused and untransfused patients will be compared.~   "
232527|NCT00512564|"~     Iron overload is well study in Thalassemia patients and it's not only related to blood~     transfusions, since intestinal iron absorption is also increased in those patients. Sickle~     cell patients didn't developed significant clinical symptoms and signs of iron overload in~     spite frequent transfusions. The purpose of this study is to assess the iron overload in~     Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and~     laboratory studies including Non Transferrin Binding Iron, Labile Iron and Hepcidin, in order~     to determine the cardiac and liver iron.~   "
232534|NCT00512473|"~     Objective: GH induces insulin resistance in muscle and fat and in vitro data indicate that~     this may involve crosstalk between the signaling pathways of the two hormones.~      Aim: To investigate GH and insulin signaling in vivo in human muscle and fat tissue in~     response to GH, GH receptor blockade and insulin stimulation..~   "
232535|NCT00512460|"~     1. The primary objectives of this study are:~             1. To determine the tolerability of RTA 744 Injection in patients with leptomeningeal~               disease (LMD) secondary to any type of primary tumor.~             2. In a selected group of 6-10 patients who will receive RTA 744 at or near the~               maximum tolerated dose (MTD), to characterize the multiple-dose pharmacokinetics of~               RTA 744 in plasma and CSF.~        2. The secondary objectives of this study are:~             1. To document any potential antitumor activity of RTA 744 in this patient population.~             2. To correlate pharmacokinetic information with clinical (efficacy and safety)~               responses, as a possible help in selecting appropriate doses for later studies.~   "
232536|NCT00512447|"~     New technology allows non-invasive monitoring of brain oxygenation~     (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various~     adult age groups. We hypothesised that baseline values in patients breathing room air are~     lower in old patients than in younger subjects and that younger patients respond increase~     their brain oxygenation more in response to supplemental oxygen.~   "
232537|NCT00512434|"~     The treatment of open tibial shaft fracture is often complicated by delayed union or~     non-union. The objective of this study is to evaluate the efficacy of autologous concentrated~     bone-marrow to accelerate healing of open tibial shaft fractures and to reduce the need for~     secondary intervention.~      In a prospective, randomized, controlled, single-blind study, 186 patients with an open~     tibial will be randomized to receive either the standard of care (fixation by nail or~     external fixator and routine soft-tissue management), or the standard of care with~     percutaneous injection, one month after fracture, of autologous concentrated bone-marrow.~     Randomization will be stratified by severity of the open wound. The primary outcome measure~     will be the proportion of patients requiring secondary intervention because of delayed union~     or nonunion within twelve months post-fracture.~   "
232538|NCT00512421|"~     The use of computer-assisted surgery by orthopedic surgeons experienced in the performance of~     total knee arthroplasty may result in better overall limb and implant alignment and fewer~     outliers as compared with the findings after manual total knee arthroplasty.~      The alignment results in previous studies were based on radiographic measurements. The~     sensitivity of radiographic assessment of limb and implant alignment may not be significant~     enough to distinguish small differences between computer-assisted surgery and manual~     techniques.~      It is possible that alignment differences that were too minor to be exposed on standard~     radiographs might result in long-term differences in the durability of arthroplasties~     performed with use of computer-assisted surgery or manual techniques.~      Moreover it is possible to measure additional implant positioning parameters with computed~     tomography (CT) technology.~      In this study, the investigators would like to add new method, for accurate measurement of~     implant alignment and to correlate its results with clinical data.~   "
232539|NCT00512408|"~     Background: Patients with congestive heart failure (CHF) show muscle mass wasting and~     decreased testosterone levels. Long-term testosterone supplementation improves walking~     distance and glucose metabolism of patients CHF. No studies have investigated the integrated~     effects of testosterone on exercise oxygen uptake muscle strength and glucose metabolism in~     patients with CHF regardless of the presence of hypogonadism.~      Aim: To assess the effect of a 12 week testosterone administration on maximal exercise~     capacity, muscle strength and insulin resistance in elderly CHF patients.~      Methods: Seventy elderly patients with stable CHF, mean age 71 ± 8 years, ejection fraction~     34 ± 1%, NYHA class II/III 38/32, were enrolled. Of these, 35 were randomized to receive~     testosterone therapy (through intramuscular injection every 6 week) and 35 to receive placebo~     both on top of maximal medical therapy. At baseline and after 12 weeks all patients underwent~     echocardiogram, cardiopulmonary test, 6-minute walking test (6MWT), quadriceps maximal~     isometric and isokinetic strength.~   "
232540|NCT00512395|"~     Epidural anaesthesia in open surgery is a effective method for analgesia and has a positive~     effect on postoperative resolution of ileus. In laparoscopic surgery, the role of epidural~     surgery is not established. This prospective observational trial evaluates the effect of~     epidural analgesia in patients undergoing elective, laparoscopic colorectal surgery.~   "
232541|NCT00512382|"~     GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the~     same patient by chance alone. Research reveals increased incidence for both to coexist~     leading to suspect a temporal association and possible causality. Therefore we conducted an~     observational study To determine the primary cause (RS or GER)using for the first time both~     PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously~     wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes~     cough/wheeze recordings it points to GER being the possible precipitating factor and vice~     versa.~   "
232542|NCT00512369|"~     Researching genetic differences in people with no prior medical conditions for better~     understanding of cardiac diseases through genetic research.~   "
232543|NCT00512356|"~     The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP)~     in preventing or reducing post-operative adhesion formation and re-formation in a subject~     population having abdominal surgery and being left with a rectal stump and a temporary stoma~     from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in~     the normal treatment of the subjects' disease. In both study groups, surgical measures to~     prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using~     powder-free gloves. In the investigational product group, AAP was applied to the rectal stump~     and the incision line while no specific additional treatment was applied in the control~     group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed~     and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant~     who did not know the result of randomization. The safety of the study drug was also~     monitored.~   "
232544|NCT00512343|"~     The objectives of this group project is to collect synovial fluid (SF) and paired sera and~     carry out preclinical studies to evaluate, alone or by combination testings, the potential of~     novel biomarkers for their prevalence and diagnostic/prognostic values in patients with~     arthritis, and to determine how therapeutic intervention regulate their levels.~   "
232545|NCT00512330|"~     In children, it remains quite difficult even in developed countries, to prove a diagnosis of~     Tuberculosis (TB). New means for diagnosis of this disease are currently being researched.~     One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of~     up to 80% in adults.~      Our study aims to evaluate this test in the diagnosis of children with TB.~   "
232546|NCT00512317|"~     To allow open-label extension to patients who have completed Protocol 1042-0600.~   "
232547|NCT00512304|"~     Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med~     2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and~     suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate~     chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the~     radiotherapy we will use 5 FU continue infusion as previously reported. The global design of~     adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue~     then four FOLFIRI.~   "
232548|NCT00512291|"~     The objective of this study is to determine the tolerability and safety of olanzapine~     administered as a subcutaneous injection to hospitalized patients with hyperactive or mixed~     delirium.~   "
232549|NCT00512278|"~     The aim of the study is to investigate in subjects receiving their first course of~     peg-interferon α-2b plus ribavirin therapy for chronic HCV infection~   "
232550|NCT00512265|"~     The purpose of this study is to evaluate the effect of high-dose n-acetylcysteine on~     inflammatory reaction, pulmonary morbidity, oxygenation and quality of life in patients~     undergoing transthoracic, partial or total resection of the esophagus for cancer.~   "
232551|NCT00512252|"~     This study is a phase I/II study to determine the safety and efficacy of AMD3100 when~     combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory~     AML.~      We hypothesize that disrupting the interaction between AML blasts and the marrow~     microenvironment with AMD3100 may enhance the cytotoxic effect of chemotherapy.~   "
232552|NCT00512239|"~     Inflammatory joint diseases are major causes of invalidity and morbidity. Rheumatoid~     arthritis (RA), the most frequent of chronic arthritides, affects close to 1% of the Canadian~     population. Direct and indirect costs of RA represent close to 1% of the gross national~     product. Recent evidence suggest that initiation of early (e.g., during the first 3-12 months~     of disease) aggressive treatment decreases both mortality and long term invalidity in RA and~     other chronic arthritides. However, a significant proportion of patients with early~     polyarthritis (EPA) have a benign evolution, even if they fulfill criteria for RA. On the~     contrary, most patients whose arthritis persist for more than 12 months have a progressive~     and destructive disease. Currently available clinical, serological and genetic markers of~     severity in arthritic patients perform poorly in EPA patients to identify those patients~     whose arthritis is likely to persist and thus who deserve an aggressive treatment.~      The Investigators propose a prospective and longitudinal study to define the contribution of~     detection of rheumatoid arthritis-specific autoantibodies (RASA), either alone or in~     combination with other markers of severity, in the prognostic evaluation of patients~     presenting with EPA. Availability of such an effective serological tool to establish~     prognosis in individual patients would improve therapeutic decisions in clinical practice.~     The same prognostic tools would represent very powerful instruments to subset patients into~     more homogeneous groups in clinical trials, increasing their power.~   "
232553|NCT00512226|"~     Iron overload is well study in Thalassemia patients and it's not only related to blood~     transfusions, since intestinal iron absorption is also increased in those patients. Sickle~     cell patients didn't develope significant clinical symptoms and signs of iron overload in~     spite frequent transfusions. The purpouse of this study is to assess the iron overload in~     Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and cardiac~     T2*MRI in order to determine the cardiac and liver iron.~   "
232554|NCT00512213|"~     The aim of this trial is to compare preoperative Imunnonutrition with standard enteral~     nutrition regarding morbidity after major abdominal surgery in patients with NRS greater 3.~      The primary end point is the complication rate until 30 days after surgery.~   "
232555|NCT00512200|"~     Geriatric patients have a high risk of developing postoperative cognitive deficits.~     Hypothetical causes are insufficient intraoperative cerebral perfusion or drugs that are~     administered in the perioperative setting. This study will investigate the role of these two~     factors in patients aged 65 or older undergoing elective surgical procedures under general~     aesthesia. Non-invasive techniques will be used to monitor intraoperative cerebral perfusion~     and anticholinergic activity in the patient's blood is determined. Data will be compared to~     those of a young (20-40 year old) group of patients undergoing elective surgical procedures~     using an identical anesthetic technique. A second control group of healthy volunteers older~     than 65 will be investigated to quantify practice effects with repeated testing of cognitive~     functions.~   "
232556|NCT00512187|"~     The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight~     reduction of at least 5%) could improve the response rate to a suboptimal dose of~     cyclosporine in patients with severe psoriasis.~   "
232557|NCT00512174|"~     Thirty patients who underwent radical cystectomy and bladder substitution and thirty people~     with native bladders will be enrolled in the study. After meticulous explanations each person~     will undergo sterile catheterization of the bladder/neobladder with a 14 Fr Foley catheter.~     After catheterization the bladder will be fully emptied. Randomly assigned volume of sterile~     saline will be injected to the bladder via the catheter by one sub investigator and the~     bladder capacity will be measured via a portable ultrasound scanner for non-invasive bladder~     volume measurement (BladderScan BVI3000) by another sub investigator. The volume injected and~     the measured results will remain in a closed envelope till the completion of the trial. After~     each measurement the first sub investigator will completely empty the bladder/neobladder and~     the process will repeat itself for a total of six measurements for each patient or first~     mention of discomfort (whichever comes first), after which the bladder will be drained once~     more and the catheter removed.~   "
232572|NCT00511979|"~     A prospective, single center, open randomized, six way crossover study comparing the dose~     response effect of four different doses of Technosphere Insulin after pulmonary function~     delivery in comparison to s.c. injection of two different doses of regular human insulin.~   "
247510|NCT00313287|"~     The purpose of this study is to determine safety and efficacy of 30 mg daily dose of~     clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.~   "
232558|NCT00512161|"~     The purpose of this study is to determine the predictors for placement of permanent~     pacemakers soon after cardiac surgery. We will measure the following to see what influence,~     if any, they have on predicting the need for permanent pacemaker implantation.~        1. Type of cardiac surgery~        2. Gender of patient~        3. Patient's age~        4. Preoperative heart rhythm and rate~        5. Duration on cardiopulmonary bypass~        6. Immediate post cardiopulmonary bypass heart rhythm and rate.~        7. All heart rhythms and rates identified in the postoperative period prior to permanent~          pacemaker implantation.~        8. Underlying heart rhythm and rates when permanent pacemaker is placed.~        9. Ejection fraction before surgery~       10. Ejection fraction immediately post-cardiopulmonary bypass~   "
232559|NCT00512148|"~     Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to~     medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is~     that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum~     detrusor pressure.~   "
232560|NCT00512135|"~     The study objective was to investigate the safety and efficacy of incobotulinumtoxinA~     (Xeomin) during repeat dose treatment of glabellar frown lines. 801 subjects with moderate to~     severe glabellar frown lines at maximum frown who completed participation in one of the~     studies in this program, i.e., MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ~     60201-0741/1 were eligible to participate in this repeat-dose study.~   "
232561|NCT00512122|"~     In critically ill patients, a strategy aimed at an early delivery of full caloric support,~     with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions~     preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less~     morbidity as compared to a strategy using only EN.~   "
232562|NCT00512109|"~     The investigators' study has 4 primary objectives. Among patients undergoing noncardiac~     surgery the investigators will determine: (1) the incidence of major perioperative vascular~     events; (2) the optimal clinical model to predict major perioperative vascular events; (3)~     the proportion of patients with perioperative myocardial infarctions that may go undetected~     without perioperative troponin monitoring; and (4) the relationship between postoperative~     troponin measurements and the 1 year risk of vascular death.~   "
232563|NCT00512096|"~     Primary Objective:~      -To evaluate the feasibility and efficacy of multimodality treatment (neoadjuvant~     chemotherapy prior to extirpative surgery) for clinical stage TXN2-3M0 squamous cell~     carcinoma of the penis.~   "
232564|NCT00512083|"~     The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of~     doses, when combined with cytarabine, in the treatment of patients with primary refractory or~     relapsed acute myeloid leukemia (AML).~   "
232565|NCT00512070|"~     Atypical antipsychotic medications, such as olanzapine, cause metabolic side effects,~     including weight gain, extra fat around the middle of the body, high blood sugar, and high~     cholesterol. One of the mechanisms by which these medications may cause these effects is by~     reducing plasma melatonin. This study is a pilot project to evaluate 1) the effect of~     olanzapine on melatonin secretion levels and 2) the effect of melatonin on olanzapine-induced~     changes in melatonin secretion in patients with schizophrenia, schizoaffective, or bipolar~     disorder.~   "
232566|NCT00512057|"~     Morbidity of patients with cardiac syndrome X (typical anginal-like chest pain and normal~     coronary arteriograms) is high with continuing episodes of chest pain and frequent hospital~     readmissions. Management of this syndrome represents a major challenge to the treating~     physician. Evidence for the important role of endothelial dysfunction and oxidative stress in~     the pathogenesis of cardiac syndrome X has been recently strengthened by the finding that~     basal superoxide production predicts future cardiovascular events in this patient group. The~     investigators have recently shown that high-dose allopurinol abolishes vascular oxidative~     stress and improves endothelial function in patients with chronic heart failure, which makes~     allopurinol a prime candidate to reduce oxidative stress in syndrome X. The hypothesis to be~     tested in this study is whether allopurinol offers dual benefits of improving vascular~     function and reducing myocardial ischaemia in patients with cardiac syndrome X. This study~     may discover a novel way to improve endothelial function and anginal symptoms which are often~     debilitating in these patients.~   "
232567|NCT00512044|"~     The purpose of this study is to determine whether local or general anaesthesia in stapled~     hemorrhoidectomy leads to a shorter operation time with a better patient comfort.~   "
232568|NCT00512031|"~     To determine how altering the expression of a gene known as PAI-1 may affect the adhesive~     capacity of cells that play a critical role in the developement of human atherosclerosis.~   "
232569|NCT00512018|"~     The purpose of this study was to assess the effects of Neuromuscular Electrical Stimulation~     (NMES) associated to an isokinetic training program in both young healthy men and women.~     Twenty subjects (10 men, 10 women; 21±1.5 years) submitted both quadriceps femoris muscles to~     a strengthening program (3 sets of 10 isokinetic concentric repetitions at 30°/s) two days~     per week for 4 weeks. One limb was submitted only to the strength training (EX) while the~     other underwent the same training program but with NMES added to each contraction (Ex+NMES).~     The current used for NMES was Russian Current (frequency of 2500 Hz, 50 bursts/s and pulse~     duration of 200 µs). The evaluation protocol included isometric and isokinetic concentric~     extensor torques at 30°/s. Men increased their torque in both tested modalities in both~     limbs, with no difference between them. The angle of peak torque increased for the EX limb,~     showing an altered tension-length relationship, which did not occur for the Ex+NMES limb or~     for women. Women increased their torque for EX limb in both modalities, which only occured~     for isometric mode in the Ex+NMES limb. However, they showed a decrease in their acceleration~     time in Ex+NMES limbs, showing they could produce a muscular contraction more readily than~     they did before training. The results of this study found that the association between NMES~     and isokinetic concentric voluntary strength training does not improve strength gains of~     voluntary training itself for young healthy subjects of both genders. However, it could~     improve neuromuscular readiness to produce torque in women.~   "
232570|NCT00512005|"~     The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate~     safety and feasibility of the iCoapsys System in patients with functional mitral valve~     insufficiency caused by annular dilation and/or papillary muscle displacement.~   "
232578|NCT00511901|"~     Patients who are admitted to subacute rehabilitation facilities following hospitalization are~     frequently anemic. The purpose of this study is to see if anemic patients treated with~     epoetin alfa will have higher hemoglobin levels and better functional recovery at 3, 8, and~     12 weeks after study entry compared to patients who do not receive epoetin alfa.~   "
232579|NCT00511888|"~     BACKGROUND Beta-blockers improve left ventricular (LV) systolic function and prognosis in~     patients with chronic heart failure. Both carvedilol and nebivolol have hemodynamic and~     clinical benefits in chronic heart failure (CHF), but it is unknown whether their pleiotropic~     properties may play a role in different subgroups of patients with CHF.~      OBJECTIVE: To compare the effects of nebivolol and carvedilol on LV function and clinical~     outcome in patients with chronic heart failure and reduced LV systolic function.~      METHODS: 160 hypertensive CHF patients, LV ejection fraction (EF) 40% and in New York Heart~     Association (NYHA) functional class II or III were randomly assigned to receive carvedilol or~     nebivolol therapy for 24 months. At baseline and after 24 months of treatment, all patients~     underwent clinical evaluation: echocardiogram and 6-minute walking test.~   "
232580|NCT00511875|"~     This 24 month randomized research study will evaluate whether doxycycline can 1) slow the~     deterioration or improve retinal function and/or 2) induce regression, or slow progression,~     of diabetic retinopathy in participants over 18 years of age with type 1 or type 2 diabetes~     with severe non-proliferative or early proliferative diabetic retinopathy.~   "
232581|NCT00511862|"~     This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere~     treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with~     metastatic disease to the liver that cannot be treated or is progressing following treatment~     with systemic or other liver-directed therapies.~   "
232582|NCT00511849|"~     The purpose of this study is to test SU011248 (sunitinib) in combination with~     paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor~     activity.~   "
232583|NCT00511836|"~     This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the~     associated brain activation patterns in alcohol-dependent adults who had recently completed~     alcohol detoxification and were seeking further treatment for their alcohol dependence. The~     study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal~     increases in response to alcohol-related cues.~      In the double-blind portion, subjects received a single administration of study drug~     (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to~     continue to the open-label portion and receive 2 additional months of treatment with VIVITROL~     380 mg.~   "
232584|NCT00511823|"~     This A Three-Part Drug-Drug Interaction Study To Evaluate Effects of Casopitant On~     Dolasetron, Granisetron or Rosiglitazone When Co-Administered in Healthy Adults~   "
232585|NCT00511810|"~     The primary objective of the study was to determine the effects of 10-week adjunctive~     supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity~     and biochemistry in adolescents with MDD.~      The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently~     increase prefrontal cortical functional activation during sustained attention and increase~     regional biochemical indices of cortical metabolism and integrity concentrations in~     association with reductions in depressive symptoms.~   "
232586|NCT00511797|"~     The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.~   "
232587|NCT00511784|"~     This study uses the PharMetrics and MarketScan US health care insurance claims database to~     estimate relative risks for non-fatal venous thromboembolism (including cerebral venous sinus~     thrombosis), ischemic stroke, and acute myocardial infarction (heart attack), in current~     users of ORTHO EVRA (norelgestromin and ethinyl estradiol contraceptive patch) compared to~     current users of oral levonorgestrel-containing oral contraceptives with 30 micrograms~     ethinyl estradiol, with special attention to duration of use.~   "
232588|NCT00511771|"~     To provide tegaserod to eligible women adult patients who did not have satisfactory~     improvement of their irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic~     constipation (CIC) symptoms with other available treatment(s) and / or patients who had~     satisfactory improvement of their symptoms with prior tegaserod treatment for IBS-C or CIC.~   "
232589|NCT00511758|"~     The overall objective of this study is to evaluate whether polarized or green filtered~     digital imaging can assist clinicians to screen for premalignant lesions in the cervix.~      The specific aims of the study are:~        -  To compare polarized and green filtered digital images of the cervix, to standard white~          light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.~        -  To develop algorithms to discriminate between normal and abnormal tissue based on~          digital images of the cervix.~        -  To analyze digital images to determine which types of optical information yield the most~          diagnostically useful data.~   "
232590|NCT00511745|"~     The purpose of this study is to evaluate the safety of rabeprazole 20mg/day in polymedicated~     patients and to examine the necessity of adjusted dosage in both therapies (rabeprazole and~     concomitant drug). Proton pump inhibitors (PPI) act in the final step of the gastric~     secretion. PPI's block ATP-ase H+/K+ in gastric parietals cells. It has been described that~     inhibition of acid secretion has produced the recovery of the gastroesophageal pathology in a~     high percentage of the patients resistant to conventional drugs. In this context, the~     objective of the study is to evaluate the safety of rabeprazole as a concomitant treatment~     and examine the clinical practice the interaction with drugs whose absorption has gastric pH~     dependence.~   "
232591|NCT00511732|"~     Designed to evaluate dose response of force-titrated prandial administration of TI as~     compared to placebo (TP) in subjects with Type 2 diabetes who were suboptimally controlled~   "
232592|NCT00511719|"~     The purpose of this study is to compare the kinetics and biodynamics of inhaled Technosphere~     Insulin with those of subcutaneous (SC) regular human insulin.~   "
232593|NCT00511706|"~     The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone~     with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients~     with subfoveal choroidal neovascularization secondary to age-related macular degeneration.~   "
232657|NCT00510874|"~     The purpose of this study is to evaluate the safety and immune response of two-doses of GSK~     Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The~     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
232594|NCT00511693|"~     A Regional Osteoporosis Coordinator located at Women's College Hospital will follow-up with~     low trauma fracture patients from 30 smaller community hospitals across Ontario. To evaluate~     whether this quality improvement program can increase post-fracture osteoporosis care in~     these individuals, hospitals will be randomized to receive osteoporosis specific~     recommendations or falls prevention advice. Patients will be asked to complete two short~     telephone surveys about their recent fracture, risk factors, osteoporosis knowledge and~     diagnostic and treatment history. All patients in the falls prevention advice group will~     receive the osteoporosis specific recommendations 6 months after their fracture.~   "
232595|NCT00511680|"~     The specific primary aims of the study are to:~        1. Test the immediate effect of the intervention at 4-months on depression in urban African~          American older adults (primary trial outcome; between group comparison). Hypothesis:~          Participants in the intervention group will report fewer depressive symptoms in~          comparison to control group participants receiving usual care.~        2. Test the maintenance effect of the intervention at 8-months on depression (within group~          comparison). Hypothesis: Participants in the intervention group will maintain reduced~          symptom presentation from 4 to 8 months.~        3. Evaluate acceptability (social validity) of the intervention and extent of engagement in~          activities by study participants (both intervention and wait-list control subjects).~      A secondary aim of this study is to assess the feasibility of conducting a clinical trial~     embedded in a community service setting and its dissemination using a community-academic~     partnership. We also propose three exploratory aims. First, we seek to evaluate the~     mechanisms of action, or pathways, by which treatment gains are obtained (Gitlin et al.,~     2000). Given that behavioral activation represents conceptually the key active ingredient of~     the proposed intervention, we plan to evaluate its mediational effect. Second, we seek to~     evaluate whether the intervention has a differential treatment effect based on a study~     participant's gender, age, and living arrangement (alone or with others). Given that previous~     research suggests that participant characteristics may moderate depressive symptoms and~     treatment outcomes, these exploratory analyses will provide insight as to whether this~     particular treatment benefits some groups more than others. Third, we seek to evaluate~     whether the intervention has short and long-term effects on quality of life, functional~     difficulty, and self-efficacy to manage day-to-day tasks. Previous research has shown that~     depressive symptoms exacerbate functional decline such that minimizing distress may have the~     added value of enhancing function and perceived efficacy for this group over time.~   "
232596|NCT00511667|"~     A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in~     patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily~     MK-0941 in subjects with T2DM with or without adequate control on metformin will be~     sufficiently safe and well tolerated to permit continued clinical investigation.~   "
232597|NCT00511654|"~     This study is being conducted to obtain information on the safety and tolerability of~     repeated doses of GW823296 for 28 days in healthy male and female subjects. In addition, the~     pharmacokinetics of GW823296 will be evaluated to confirm the doses to be used in Phase II~     efficacy studies. The effect of repeat dose (RD) of GW823296 on CYP3A4 enzyme activity will~     be investigated evaluating the pharmacokinetics of midazolam and urine~     6-?-hydroxycortisol/cortisol ratio.~   "
232598|NCT00511641|"~     The goal of this research study is to learn more about how women feel about an ovarian cancer~     screening program that involves getting a blood test to measure CA 125 levels. This includes~     finding out about women's quality of life and whether they are concerned or worried about~     their risk of developing cancer. This study also seeks to find out whether elevated CA 125~     levels affect participants in terms of cancer worries or concerns.~   "
232599|NCT00511628|"~     The purpose of this study is to evaluate the safety of risperidone treatment in patients who~     are overweight and/or obese.~   "
232600|NCT00511615|"~     The hypothesis of this research project is that topical application of the anti-EGFR or~     anti-E6/E7 contrast agents followed by optical imaging will yield images that reflect spatial~     variations in expression that correlate with the presence of cervical precancer. To gather~     feasibility data the investigators will:~        1. Obtain cervical specimens from women with high grade squamous intraepithelial lesions~          (HGSILs) being treated with the loop electrosurgical excision procedure (LEEP).~        2. After Loop Electrosurgical Excision Procedure (LEEP) is performed, obtain low and high~          resolution optical images before and after applying contrast agents topically to the~          epithelial surface of the tissue for 30 minutes before rinsing.~        3. Submit the specimen for histology, and have it sectioned and stained using both H&E and~          immunohistochemical staining for EGFR or E6/E7. The images will be reconstructed into a~          two dimensional map delineating areas of Cervical Intraepithelial Neoplasia (CIN) and of~          EGFR or E6/E7 overexpression. Maps of the pathology will be compared to those obtained~          from the intact cervix exposed to the contrast agent.~   "
232601|NCT00511602|"~     Primary objective to evaluate the effect of a 12-week treatment period with prandial~     administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary~     objective is to Evaluate the safety and tolerability of a 12-week treatment period of~     Technosphere Insulin and Technosphere Placebo.~   "
232602|NCT00511589|"~     T. cruzi infection affects approximately five million people in Brazil. The diagnosis of the~     chronic phase of infection is performed by indirect serological methods which, nevertheless,~     leave inconclusive results. One of the direct methods used for T. cruzi identification, blood~     culture in LIT (liver infusion tryptose) medium, presents low sensitivity in that phase of~     the disease. A negative result does not eliminate the possibility of infection, but a~     positive test has high absolute diagnostic value, which enables the indication of~     antiparasitic treatment. Molecular diagnosis (PCR) in this phase is promising and can be used~     as a confirmatory test, particularly when individuals present inconclusive results in~     conventional serological tests, such as ELISA, HAI and IFI. This study aimed at improving~     blood culture sensitivity in LIT medium by performing PCR in individuals with positive and~     inconclusive serology for chagasic infection.~   "
232603|NCT00511576|"~     The purpose of this study is to test the combination of an experimental drug known as~     MGCD0103 given along with an FDA-approved drug called docetaxel. This is a Phase 1 study that~     will look at different doses of MGCD0103 given along with docetaxel in order to better~     understand the effects (positive and negative) of this combination on the subject's body and~     disease.~      The study would like to find the following information:~        -  How long MGCD0103 and docetaxel stay in the subject's body;~        -  What effects, good and/or bad, MGCD0103 and docetaxel have on the subject and on his/her~          cancer; and~        -  If the genetic and chemical make-up of the subject's blood cells and tumor cells play a~          role in how you respond or do not respond to MGCD0103 and docetaxel.~   "
232604|NCT00511563|"~     To better understand the way that GW876008 and GSK561679 work on hormone responses in~     patients with Irritable Bowel Syndrome.~   "
232718|NCT00510081|"~     The objective of this study is to determine the effectiveness of a filler in improving~     wrinkles.~   "
232605|NCT00511550|"~     Peripheral blood stem cells (PBSCs) collected following stimulation with filgrastim are~     commonly used for autologous hematopoietic transplants. PBSCs are also now being used for~     some syngeneic and allogeneic hematopoietic transplants involving HLA-matched sibling donors.~     However, many issues remain unanswered about the use of PBSCs for allogeneic transplants and~     the effects of filgrastim on healthy individuals. The purpose of this study is to determine~     the effectiveness of filgrastim stimulated PBSCs in hematopoietic cell transplants involving~     unrelated donors and to determine the effects of this donation process on unrelated stem cell~     donors.~   "
232606|NCT00511537|"~     This study performs HLA matched stem cell transplantation from unrelated donors in adults who~     require stem cell transplantation but do not have a matched related donor available. The~     incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded.~     This study also monitors the activity and toxicity of total body irradiation and~     cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.~   "
232607|NCT00511524|"~     GW842166X is being developed for the treatment and management of inflammatory pain. GW842166X~     is a CB2 receptor agonist and the mechanism is not fully understood, although it is thought~     that for the anti-inflammatory action the drug is required to cross inot the brain from the~     blood. This study aims to look at if the drug crosses into the brain once given orally using~     an imaging technique called positron emission tomography.~   "
232608|NCT00511511|"~     The aim of the study is to find simple clinical and laboratory parameters to predict the~     development of hypertension and to elucidate the mechanism of hypertension during treatment~     with the tyrosine kinase inhibitor Sunitinib.~   "
232609|NCT00511498|"~     The ability of sildenafil to aid in the return of erections after nerve-sparing radical~     prostatectomy has been established. Patients who had either one or both neurovascular bundles~     spared demonstrated dramatically better responses to as needed sildenafil than those that~     did not, and a positive erectile response to sildenafil was only seen in patients in whom at~     least one NVB was spared. This study has been designed to determine if sildenafil taken~     nightly works better than sildenafil on as as needed basis for the return of erectile~     function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid~     return of erectile function after nerve-sparing laparoscopic radical prostatectomy.~   "
232610|NCT00511485|"~     This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in~     participants with progressive adenocarcinoma of the lung.~   "
232611|NCT00511472|"~     A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type~     2 diabetics being treated with basal insulin.~   "
232612|NCT00511459|"~     This is a phase 2, randomized, placebo controlled, multi-center study to estimate the~     treatment effect and evaluate the safety and tolerability of AMG 386 in combination with~     paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative~     metastatic or locally recurrent breast cancer.~      AMG 386 is a man-made medication that is designed to stop the development of blood vessels in~     cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called~     angiogenesis, to obtain a supply of oxygen and nutrients to grow.~   "
232613|NCT00511446|"~     Combination regimens of 3 active drugs have shown promising activity in treatment of~     metastatic gastric cancer. Docetaxel combined with cisplatin and 5-fluorouracil (FU) yielded~     superior overall survival and response rates when compared to standard cisplatin and 5-FU.~     However, a toxicity profile showed the need for development of less toxic modifications. In a~     prior phase I trial, the maximum tolerated dose was defined. In this phase II trial, a first~     evaluation of activity will be performed.~   "
232614|NCT00511433|"~     The primary purpose of this study is to evaluate the effects of the nomegestrol~     acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.~   "
232615|NCT00511420|"~     The purpose of this study is to evaluate the effects of optimized composition chocolates that~     include natural ingredients with demonstrated biological activity are observed~     cardioprotectores effects in the human.~   "
232616|NCT00511407|"~     Although conventional hemodialysis removes waste products and corrects fluid imbalance, it~     does not replace critical absorptive, metabolic, endocrine, and immunologic functions~     performed by healthy renal tubule cells. This trial involving patients with acute renal~     failure evaluates the efficacy and safety of an extracorporeal renal assist device (RAD)~     containing human renal tubule cells connected to a conventional hemodialysis circuit. It is~     hypothesized that short-term (72-h) use of this cell therapeutic device will improve survival~     of ARF patients compared to patients receiving only conventional continuous renal replacement~     therapy.~   "
232617|NCT00511394|"~     Cirrhosis is frequently complicated by derangement of body fluid homeostasis resulting in~     accumulation of large amounts of extracellular fluid in the peritoneal cavity (ascites) and~     interstitial tissue (edema). Studies showed that patients with cirrhosis and ascites have~     marked circulatory dysfunction. Albumin infusions have been used for many years in the~     management of patients with cirrhosis and ascites in an attempt to reduce the formation of~     ascites and/or improve circulatory and renal function. While some of these indications for~     albumin infusions are supported by the results of randomised studies, others are based on~     clinical experience and have not been proved in prospective investigations. Therefore, the~     use of albumin infusions in patients with cirrhosis is controversial. Recently, this debate~     has been fostered by the high cost and limited availability of albumin and the results of a~     meta-analysis showing that albumin administration may increase mortality in critically ill~     patients. In cirrhotics, there is a significant improvement in the low effective arterial~     blood volume, which may be important in the prevention of circulatory dysfunction and in~     preventing renal impairment. However, in an already fluid overload state such as that of~     cirrhosis, albumin infusion predisposes the individual to develop pulmonary edema. There is~     no study demonstrating acute effect of albumin infusion on hemodynamic parameters, in~     cirrhotic patients. Neither is there is data concerning comparison between albumin and normal~     saline. It is postulated that it may increase portal pressure thereby increasing the risk of~     variceal bleed. This study hypothesizes that albumin infusion might lead to alteration in~     portal and pulmonary hemodynamics in decompensated cirrhotic patients. Included patients of~     cirrhosis with ascites (based on inclusion and exclusion criteria) will undergo baseline~     investigations (systemic hemodynamics, pulmonary hemodynamics, portal hemodynamics). They~     will be randomized into two groups, each of 8. One group will receive infusion of 100 ml 20%~     albumin over 3 hours, and the other will receive infusion of 100 ml normal saline over 3~     hours. Repeat hemodynamic studies will be performed after the infusion finishes. All results~     will be expressed as mean ± SD or frequency (%). Comparisons will be performed by the~     Student's t test or with the Wilcoxon's test~   "
232618|NCT00511381|"~     Two major limitations of existing audiometric newborn hearing screening programs are their~     inability to detect forms of deafness that are not expressed at birth and the low compliance~     with obtaining recommended audiologic confirmation and/or follow-up. Molecular genetic tests~     on blood spots from all newborns will identify those at risk for the most frequent causes of~     late-onset hearing loss and to add these infants to the group who should receive continued~     audiologic monitoring.~   "
232619|NCT00511368|"~     The purpose of this study is to evaluate antiretroviral activity of up to five different oral~     doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced~     patients, who have documented genotypic resistance to at least one major mutation from the~     IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs. Patients will also be~     monitored for side effects, and the pharmacokinetics of bevirimat will be determined.~   "
232620|NCT00511355|"~     The primary purpose of this study is to evaluate the effects of the combined oral~     contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal~     function, and thyroid function.~   "
232621|NCT00511342|"~     The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral~     contraceptive (COC) on bone mineral density (BMD).~   "
232622|NCT00511329|"~     The investigators hypothesize that the anabolic effects of Genotropin (somatropin) will~     improve the height and weight of children with inflammatory based chronic illness who have~     failed to grow despite receiving adequate nutrition. The investigators will test the~     hypothesis by treating 32 chronically ill children (16 JRA and 16 Crohn's) with growth~     hormone (GH) for 12 months and comparing them to baseline.~   "
232623|NCT00511316|"~     Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of~     dysphagia and food impaction in patients with EE.~      Also evaluate tolerance and safety of oral montelukast in treatment of EE.~   "
232624|NCT00511303|"~     This is a Phase II, open-label, multi-center trial designed primarily to evaluate the rate of~     complete or major cytogenetic response of STI571 as demonstrated by a decrease in the~     percentage of Ph chromosome positive cells in the bone marrow, in patients with CML who are~     refractory to or intolerant of interferon-alpha.~      During the core phase of the study, patients will receive once daily oral administration of~     STI571 at a dose of 400 mg, for up to 12 months. After completing 12 months of therapy~     patients may be eligible to receive additional therapy provided that, in the opinion of the~     investigator, the patient has benefited from treatment with STI571 and in the absence of~     safety concerns. Patients will receive STI571 on an outpatient basis.~      During the extended phase (which is of indefinite duration), patients may continue STI571~     until either progression to accelerated phase, blast phase, death, the development of~     intolerable toxicity, or the investigator feels it is no longer in the patient's best~     interest to continue therapy, whichever comes first. The number of visits will be at a~     reduced frequency. Patients who discontinue study drug will be followed for survival for up~     to 5 years.~      STI571 will be considered active if the interferon-refractory patient population satisfies~     the target of achieving a complete or major response at a rate of at least 30%, within the~     preset error limits. Cytogenetic responses will be evaluated every three months and~     categorized as either complete (0% Ph+ chromosome cells), or major (1 to 35% Ph+ chromosome~     cells) responses. STI571 will be discontinued for any patient whose disease progresses to~     either the accelerated phase or blast crisis.~      A minimum of 100 patients who are interferon refractory will receive STI571 administered at a~     dose of 400 mg once a day. In addition, the protocol is also open for patients who are~     intolerant to interferon-alpha in order to get a preliminary evaluation of their response to~     STI571 therapy. Up to 100 intolerant patients will be enrolled. Enrollment of intolerant~     patients will cease at 100, or whenever the 100 refractory patients are accrued, whichever~     comes first.~   "
232625|NCT00511290|"~     In the present study inflammatory mediators will be isolated in induced sputum and exhaled~     breath condensate and will be correlated with particulate matter measured in these~     samples.Particulate matter will be assessed by partcle size distribution method and shape~     analysis.~      The aim of the study is to perform biological monitoring in environmental and occupational~     diseases in a non invassive fashion.~   "
232626|NCT00511277|"~     The purpose of this study is:~      To investigate whether a treatment with quetiapine for six months in patients with~     first-episode psychosis may be effective in treating depressive symptoms.~      To investigate whether a treatment with quetiapine for six months in patients with~     first-episode psychosis may be effective in mania-like symptoms and to evaluate the general~     efficacy in psychopathology as well as the safety and tolerability of quetiapine.~   "
232627|NCT00511264|"~     Laparoscopic Ultrasound (LUS) is an important part of the pre-treatment evaluation of~     patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver~     cancer). When a suspect lesion is visualized during LUS a biopsy should be provided in order~     to differentiate between benign and malignant lesions. A new system for LUS guided biopsy has~     been developed, but how often these biopsies are clinically relevant (i.e. changing patient~     management)and how reliable are these biopsies are unknown.~      The study hypothesis is that LUS guided biopsies are accurate and clinically relevant in the~     pre-treatment evaluation of patients with upper gastrointestinal tract cancer.~   "
232628|NCT00511251|"~     Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung~     samples first in induced sputum in correlation to disease second by comparing hazardous~     particles in induced sputum to the analysis in lung tissue and finally by assessing if the~     particles present in transplanted patients correlated with occupational history.~   "
232629|NCT00511238|"~     To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects~     with relapsed and refractory multiple myeloma.~      Patients must have received prior treatment with bortezomib and either thalidomide or~     lenalidomide and be refractory to their last treatment.~   "
232630|NCT00511225|"~     Will oral vitamin improve strength, bone quality, pain and quality of life. This is a double~     blind, randomized placebo controlled study using 10,000 IU of cholecalciferol vs placebo.~   "
232631|NCT00511212|"~     The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy~     with antibacterial agents for severe peritonitis after lower digestive tract surgery.~   "
232632|NCT00511199|"~     The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding~     patterns (cycle control), general safety and acceptability of the nomegestrol~     acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged~     18-50 years.~   "
232633|NCT00511186|"~     The purpose of this study is to investigate the safety and tolerability of AP in sepsis~     patients with renal failure and to investigate the effect of AP on inflammatory and clinical~     parameters in sepsis patients with renal failure.~   "
232634|NCT00511173|"~     This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in~     diagnosed patients requiring warfarin therapy.~   "
232643|NCT00511056|"~     Study Hypothesis: Do certain risk behaviours impact/predict levels of HIV antiretroviral~     adherence?~      Objectives:~        -  To assess risk behavior in HIV-positive individuals receiving highly active~          antiretroviral therapy.(HAART)~        -  To assess levels of adherence in the same subjects at the same time point~        -  To determine if there is a correlation between HAART adherence and risk behaviour~   "
232719|NCT00510068|"~     The purpose of this study was to evaluate progression free survival in those participants~     assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus~     Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.~   "
232635|NCT00511160|"~     Myocarditis is mainly caused by cardiotropic viruses. In recent time viruses found in~     endomyocardial biopsies mainly consist of parvovirus B19 (PVB19) and human herpesvirus 6~     (HHV6). A definite causal link between virus-genome detection of PVB19 and/or HHV6 (via pcr~     techniques)and cardiac inflammation and dysfunction is however still missing.~      Primary objective:~      To determine the prevalence of PVB19 and HHV6 virus genome in heart muscle biopsies of~     cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae~      Secondary objectives:~        1. Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance,~          ecg, history, inflammatory markers) with biopsy results~        2. Prognostic value of virus prevalence for the postoperative course~      Primary hypothesis:~      Patients without clinical evidence of myocarditis or myocarditic sequelae demonstrate to a~     significant lesser extent inflammatory activity and virus genome in their myocardium as~     compared to patients being clinical suspicious for myocarditis.~   "
232636|NCT00511147|"~     Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by~     platelet destruction and thrombocytopenia (peripheral blood platelet count < 150 x 10^9/L).~     IVIG therapy is useful in patients in whom the platelet count has to be raised either due to~     bleeding signs, or where bleeding is predicted (e.g., surgery or parturition). The primary~     goal of treatment is to maintain the platelet count at a hemostatic level. This study will~     test the safety and efficacy of IGIV3I Grifols 10% in the treatment of patients with chronic~     ITP.~   "
232637|NCT00511134|"~     Objectives:~      The primary objective of this study is to determine the efficacy of eszopiclone at treating~     sleep problems related to withdrawal from nicotine in healthy smokers attempting smoking~     cessation.~      Sleep disturbances are a significant problem for smokers who are trying to quit smoking.~     Smokers may be more likely to have sleep problems and both nicotine withdrawal and agents~     used to aid smoking cessation (e.g., pharmacotherapies) may disrupt sleep. Lunesta~     (eszopiclone) is a medication that has been approved by the FDA to treat insomnia.~     Eszopiclone's efficacy for treating insomnia makes it a promising agent for treating nicotine~     withdrawal-related symptoms of sleep disturbance.~      This study will be 7 weeks duration. All participants will begin taking Zyban at the~     beginning of week 1 and will be asked to try to quit smoking at the beginning of week 2.~     Participants will also begin to take Lunesta or matched placebo (3 mg qd x 6 weeks) on the~     target quit date at the beginning of week 2. All subjects will receive eight (8) weekly~     sessions of brief individual supportive smoking cessation counseling.~      Hypothesis:~      It is hypothesized that significantly fewer sleep problems will be reported by participants~     taking Lunesta as compared to placebo. Specifically, it is expected that participants taking~     Lunesta will report less difficulty falling and staying asleep, higher sleep quality, and~     less insomnia-related fatigue and distress than participants taking placebo.~   "
232638|NCT00511121|"~     This is a phase II multicenter, open-label study designed to investigate the feasibility~     (tolerance, compliance and safety) of a combination of the tyrosine kinase inhibitor STI 571~     (GLIVEC, Novartis Pharma) with a pegylated *-Interferon 2b (PEG INTRON). The rationale for~     testing this combination is that 1) aIFN is curently the first line agent for the treatment~     of CML, 2) the pegylated formulation of aIFN is more convenient and is better tolerated than~     the conventional formulation, 3) STI571 is currently the most promising investigational agent~     for the treatment of CML because it is targeted to the molecular bases of the disease, is~     effective also in the advanced phases of the disease, and is effective also in the cases who~     are resistant to aIFN, 4) the mechanisms of action of the two agents are different. Therefore~     the combination of STI571 and PEGINTRON is likely to provide the best treatment of CML and to~     be tested very soon in randomized phase III studies of efficacy. So far STI571 and PEGINTRON~     have been investigated separately. The present study is an exploratory study that has been~     planned with the aim of evaluating the adverse events and the safety of the combination, so~     as to identify a safe and tolerable regime that can be tested prospectively for efficacy in a~     subsequent, randomized phase III study. Based on available knowledge and data, STI571 is more~     specific and can be more effective than PEGINTRON. Therefore in this exploratory study STI571~     is given a priority over PEGINTRON as to dose and dose adaptation. Sixty subjects with~     chronic phase CML, previously untreated with any one of study drugs, will be enrolled over a~     3 months period and will be treated and studied for 12 months. The patients can be pretreated~     with hydroxyurea , whenever required, hence are treated with STI 571 at a fixed dose (400mg)~     and with PEG-Intron at doses ranging from 50 to 150 *g weekly (the first cohort of 20~     patients at 50 *g/w, the second cohort of 20 patients at 100 *g/w and the third cohort of 20~     patients at 150 *g/w). The response (hematologic, cytogenetic and molecular) to the~     combination treatment will be evaluated every 3 months, and the pharmacokinetics of study~     drugs will be studied in a sample of study patients. The duration of the study is 12 months,~     for a total trial time of 15 months.~   "
232639|NCT00511108|"~     A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin~     alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who~     have inadequate glycemic (blood sugar) control.~   "
232640|NCT00511095|"~     The purpose of this study is to further evaluate the safety and seroprotective immune~     response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects~     11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.~   "
232641|NCT00511082|"~     -  To investigate the safety and tolerability of OPB-31121 following repeated oral~          administration of OPB-31121 in patients Non-Hodgkin's Lymphoma(NHL) or Multiple~          Myeloma(MM)~        -  To determine the potential dose-limiting toxicities and maximum-tolerated dose in~          patients treated with OPB-31121~        -  To determine the pharmacokinetics and anti-tumor efficacy of OPB-31121 in patients~   "
232642|NCT00511069|"~     Ph+ leukemias (i.e.Chronic Myelogenous Leukemia (CML) and (Ph+) Acute Lymphoblastic Leukemia~     are malignant clonal disorder of the hemopoietic stem cell due to reciprocal translocation of~     genetic material between chromosome 9 and 22 giving rise to the translocation t(9;22) (q2.2;~     q2.1). The translocation causes the formation of a new hybrid gene (bcr-abl) that codes for a~     185 kb or 210 kb cytoplasmic protein (P185 and P210 respectively) that by autophosphorylation~     activates a number of signaling pathways involved in cell proliferation, maturation,~     apoptosis and adhesion, leading to the malignant cell transformation1-3. The course of the~     disease goes on through a chronic phase (CP), usually lasting some years, that is~     characterized by a massive myeloid hyperplasia with hyperleukocytosis and splenomegaly. The~     CP is almost always followed by an accelerated or blastic phase (ABP) where the leukemic~     process acquires the characteristics of acute leukemia. The ABP usually lasts some months and~     terminates with the death of the patient3.~      The frequency of CML in western countries ranges between 10 and 15 per million persons (age -~     standardized). It is rare in children. The median age is 55 years.~      Current treatment of CML includes conventional chemotherapy, allogeneic bone marrow~     transplantation (allo BMT), alpha-interferon (alpha-IFN)and imatinib.~   "
232656|NCT00510887|"~     The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib~     (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients~     with follicular cell lymphoma.~   "
232644|NCT00511043|"~     This is a phase II open label study to assess the efficacy and safety of PTK787/ZK222584 in~     adults with relapsed or refractory diffuse large cell lymphoma (DLCL). All subjects will~     receive PTK787/ZK222584. Subjects who tolerate the study target dose of 1250mg will remain on~     that dose until study completion at 12 months or until disease progression, unacceptable~     toxicity, withdrawal of consent or non-compliance with the protocol requirement.~   "
232645|NCT00511030|"~     The purpose of this study is to determine the stability of capillary HBA1c blood samples~     collected by the participant with this kit and mailed to the laboratory at Children's Mercy~     Hospital.~   "
232646|NCT00511017|"~     The goal of this clinical research study is to find the highest tolerable dose of~     doxercalciferol that can be given to pediatric patients with relapsed solid tumors. The~     safety of this drug will also be studied. Another goal is to measure the effect of the study~     drug on the blood levels of calcium and vitamin D.~   "
232647|NCT00511004|"~     This study is conducted in Kerala, India. It will determine whether a new treatment regimen~     of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the~     disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection~     with very small parasitic worms that are spread by mosquitoes. The disease can cause swelling~     of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or~     arms called elephantiasis. The study will see if a higher and more frequent dose of~     albendazole is better at clearing filarial worms from the blood than the current treatment.~      Healthy people between 18 and 55 years of age who are in good health and who are infected~     with filarial worms may be eligible for this study.~      Participants undergo the following procedures:~      3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital~     in Kerala, India~        -  Random assignment to receive either: 400 mg albendazole and DEC 300 mg given once a year~          for 2 years (standard treatment); or 800 mg albendazole and DEC 300 mg given once a year~          for 2 years; or 800 mg albendazole and DEC 300 mg given twice a year for 2 years.~        -  Urine pregnancy test for women of childbearing age .~        -  Ultrasound test to look for filarial worms.~        -  Treatment dose.~        -  Monitoring for symptoms~           6-month 3-day hospital stay~        -  Medical history, physical examination and blood test.~        -  Repeat ultrasound in subjects whose first ultrasound detected adult worms.~        -  Treatment dose for subjects receiving medicine every 6 months.~        -  Urine pregnancy test for women of childbearing age.~           1-year 3-day hospital stay~        -  Medical history, physical examination and blood test.~        -  Treatment dose.~        -  Repeat ultrasound in subjects whose first ultrasound detected adult worms.~        -  Urine pregnancy test for women of childbearing age.~           18-month 3-day hospital stay~        -  Medical history, physical examination and blood test.~        -  Treatment dose for subjects receiving medicine every 6 months.~        -  Urine pregnancy test for women of childbearing age.~           24-month 3-day hospital stay~        -  Medical history, physical examination and blood test.~        -  Treatment dose.~        -  Repeat ultrasound in subjects whose first ultrasound detected adult worms.~        -  Urine pregnancy test for women of childbearing age.~   "
232648|NCT00510991|"~     The aim of this study is to compare the efficacy of noninvasive positive pressure ventilation~     versus best medical therapy in patients with acute severe asthma~   "
232649|NCT00510978|"~     All of us have millions of bacteria living in our gut. These bacteria are very important to~     our health providing us with protection against infections of the gut, allowing us to gain~     extra nutritional value from food we eat and helping our immune system. Changes in the~     balance of these many bacteria can make us vulnerable to infections both from within and from~     outside the gut. Certain bacteria may also be directly associated with some diseases of the~     gut. Research by doctors and scientists into relationships between the bacteria normally~     found in our gut and certain diseases of the gut is helping to develop food supplements and~     other therapies to treat these diseases.~      This study involves research into the usefulness and safety of two probiotic products in~     maintaining remission in Crohn's disease and ulcerative colitis. Approximately 360 patients~     with Crohn's disease and ulcerative colitis from Ireland, Finland and Spain will be involved~     in the study. The yoghurts used in this study contain either Lactobacillus salivarius subsp.~     salivarius or Bifidobacterium infantis.~   "
232650|NCT00510965|"~     The purpose of the study is to investigate the efficacy of a new drug called ranibizumab in~     the treatment of choroidal neovascularization in underlying angioid streaks due to~     Pseudoxanthoma elasticum. 10 patients will receive monthly injections of the drug in one eye~     over a period of one year.~   "
232651|NCT00510952|"~     The purpose of this study is to examine the effectiveness and safety of insulin lispro~     protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in~     adults with type 2 diabetes.~   "
232652|NCT00510939|"~     This is one of the first studies of combination of Zarnestra plus Velcade in man. A primary~     objective of the study is therefore to assess the safety and tolerability of multiple doses~     of Zarnestra plus Velcade in patients with AML.~      New treatments for patients that are untreatable with intensive chemotherapy aged de novo AML~     patients or post-relapse AML are urgently required since, at present, many of the drugs used~     for second line therapy are the same as those used for first induction and response rates are~     much lower.~        -  The following evidence suggests that Velcade plus Zarnestra can be an attractive~          therapeutic combination for: AML patients.~        -  Affymetrix gene profiling data showed expression of NFkB1 in all of 5 myeloid cell lines~          cell lines tested and 35% of over 250 patient samples ( data generated in collaboration~          with Sergio Ferrari and Pier Paolo Piccaluga unpublished results, our Institute and~          University of Modena,Italy)~        -  Preclinical evidence showed that AML cells in suspension culture were prevented to~          develop de novo drug resistance and mediated drug resistance.~      In Part B additional patients with AML will be treated to further characterize the~     tolerability,biological effects, and clinical efficacy of the combination Velcade plus~     Zarnestra. Patients on treatment for AML will undergo regular bone marrow aspirates and~     biopsies to assess responses to treatment. This will facilitate frequent assessment of~     biological endpoints (reduction in expression and phosphorylation of IKKb kinase, and~     downstream markers of signalling along with apoptosis, survival, proliferation and cellular~     size and ploidy) will be made in an attempt to confirm that the desired biological activity~     has been achieved at the maximum tolerated dose.~   "
232653|NCT00510926|"~     Results in CP are better in patients treated early after the onset of the disease with~     respect to late CP . To date, the early McR rate to imatinib is clearly higher in low and~     intermediate risk versus high risk (88 and 84% versus 65%). High dose of imatinib, as shown~     in phase I-III trials may offer the possibility to increase the response rate of patients~     belonging to this risk category.~   "
232654|NCT00510913|"~     A study to compare the conversion to Prograf® (tacrolimus) to the continuation of~     cyclosporine in patients at risk for chronic renal allograft failure~   "
232655|NCT00510900|"~     The proposed work seeks to further understand the effects of LAA occlusion on cardiac~     structure and function, and in homeostasis.~      Numerous studies have implicated the left atrial appendage (LAA) as the source of the vast~     majority of left atrial thrombi in the setting of AF3.~      The University of Pittsburgh Medical Center will be implanting a Left Atrial Appendage filter~     system (the WATCHMAN® Left Atrial Appendage Filter System, manufactured by Atritech, Inc.).~     We aim to follow these patients for six months post implant in order to assess their heart~     rhythm, function, and to do blood tests to evaluate for neurohormonal changes.~   "
232720|NCT00510055|"~     The primary objective of this study is to look at the efficacy of subdermal manipulation and~     filler injection in the improvement of acne scar appearance.~   "
232658|NCT00510861|"~     In the recent years, there is an increasing tendency to the parenthood delay in developed~     countries, and there is not enough information available regarding the influence of the~     male's age on fertility. If any, the negative impact should be acting at advanced ages.~      Our aim with this work was to determine the role of paternal age on IUI results embryo~     quality and IVF outcome. Evenmore, in order to standardize the female factor, good quality~     oocytes (from fertile oocyte donors) and only first IVF cycles in young women were~     considered.~   "
232659|NCT00510848|"~     Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of~     the knee joint are treated with an operative ACL-reconstruction: one group of patients with a~     reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction~     with an allograft tendon (tibialis posterior). The same surgical technique, the same fixation~     technique and the same rehabilitation protocol will be used in both groups. Follow-up will be~     done during 2 years.~   "
232660|NCT00510835|"~     The ProCESS study is large, 5-year, multicenter study of alternative resuscitation strategies~     for septic shock. The study hypothesizes that there are golden hours in the initial~     management of septic shock where prompt, rigorous, standardized care can improve clinical~     outcomes.~   "
232661|NCT00510822|"~     This multicenter study aims to investigate the safety and efficacy of cimicoxib, a selective~     COX-2 inhibitor, in combination with sertraline compared to sertraline combined with placebo~     in patients with major depression. This clinical study is based on the assumption that~     adjunctive treatment of major depression with a COX-2 inhibitor may be beneficial.~   "
232662|NCT00510809|"~     To determine the effects of policosanol on the cholesterol profile.~   "
232663|NCT00510796|"~     Primary Objectives:~      To test the feasibility of combined colon and endometrial cancer screening in women with~     increased risk for colon and endometrial cancer.~      To measure patient satisfaction for the combined procedure.~   "
232664|NCT00510783|"~     This study is looking at three seizure medicines. Patients with seizures are usually treated~     with phenytoin (Dilantin) or Fosphenytoin. These medicines can be given intravenously (IV)or~     by mouth. Another seizure medicine, levetiracetam (Keppra) can now be given this way also.~     This study will compare IV phenytoin (Dilantin) and IV fosphenytoin to levetiracetam (Keppra)~     in patients who have had a recent seizure. Only patients with a history of seizures can be~     involved. The patient must present to the emergency department within 4 hours of a seizure.~     The purpose of this study is to compare these three drugs, phenytoin (Dilantin),~     fosphenytoin, and levetiracetam (Keppra). The investigators are looking to see if these drugs~     can prevent another seizure in the next 24 hours. We are also looking for any possible side~     effects.~   "
232665|NCT00510770|"~     The purpose of this study is to determine the effectiveness of continuous positive airway~     pressure compared to standard treatment in preventing the need for intubation and mechanical~     ventilation in patients who develop acute hypoxemia after liver transplant.~      Hypoxemia complicates the recovery of 30-50 % of patients after abdominal surgery;~     endotracheal intubation and mechanical ventilation may be required in 8-10 % of cases~     increasing morbidity and mortality and prolonging intensive care unit and hospital stay.~   "
232666|NCT00510757|"~     This study is designed to collect normative data on cervical isometric strength and range of~     motion to supplement an existing normative data base.~   "
232667|NCT00510744|"~     Hypothesis: Bypass of the upper GI tract with bariatric surgery results in suppression of~     pancreatic function resulting in maldigestion and further malabsorption. In this study we~     will measure pancreatic secretion in previously obese gastric bypass patients with excessive~     weight loss. If malabsorption is associated with diminished pancreatic secretion, we will~     test over a 3 month period whether supplementation with enzyme supplements prevent further~     weight loss.~   "
232668|NCT00510731|"~     This is a prospective study to evaluating the ability of the PD2i Cardiac Analyzer to predict~     the risk of serious heart rhythm abnormalities in high-risk patients that do not already have~     an Implantable Cardioverter Defibrillator.~   "
232669|NCT00510718|"~     This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to~     treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional~     patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients~     who tolerate the drug and do not progress will be allowed to continue to look for PSA~     response.~   "
232670|NCT00510705|"~     Chronic inflammatory activation in fat tissue can be the link between adiposity and an~     increased risk for atherosclerosis. The aim of this study is to investigate how molecular~     alterations in fat tissue can be influenced by regular physical exercise training alone or in~     combination with a medical therapy (glitazone or metformin) in obese patients with severe~     coronary artery disease (CAD) and impaired glucose tolerance.~   "
232671|NCT00510692|"~     This purpose of this study is to investigate whether the number and size of rectal polyps can~     be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified~     form of a naturally occurring substance, the omega-3 fatty acid, eicosapentaenoic acid (EPA).~   "
232672|NCT00510679|"~     The objective of this study was to determine the effectiveness and cost-effectiveness of a~     package of interventions to support health workers in Benin (in West Africa) who had been~     trained to use Integrated Management of Childhood Illness guidelines (i.e., guidelines~     intended to improve the treatment of childhood illnesses).~   "
232673|NCT00510666|"~     Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain~     management. Although several drugs are recognized as effective therapeutic options, optimal~     selection of drugs in hysterectomy patients underwent different anesthesia treatments remains~     unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce~     different analgesic effects with intravenous PCA after abdominal hysterectomy.~   "
232674|NCT00510653|"~     Primary Objectives:~        1. To determine the efficacy of Gleevec in patients with recurrent platinum-resistant,~          taxane-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube~          cancer whose tumor expresses either c-KIT, platelet-derived growth factor receptor~          (PDGRF), or ABL.~        2. To determine the nature and degree of toxicity of Gleevec in this cohort of patients.~   "
232723|NCT00510016|"~     To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will~     be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal)~     than tincture of opium (DTO) alone.~   "
232675|NCT00510640|"~     Due to arguments showing that angiogenesis could be involved in progression of metastatic~     thyroid carcinoma and to objective response during previous studies with sunitinib (an~     angiogenic oncology drug also known as Sutent), this study, THYSU, is justified to evaluate~     the efficacy of sunitinib in metastatic thyroid carcinoma. Furthermore, the standard~     treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is~     limited to radioiodine. When radioiodine becomes ineffective, there is no standard treatment~     despite some use of chemotherapy.~      The objective of the trial is to determine the objective tumor response rate (efficacy) in~     patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid~     carcinoma treated with sunitinib; a secondary objective is to evaluate the safety of~     sunitinib in these patients.~      The THYSU trial is a phase II, French multi-center study. This trial's plan is to enroll 75~     patients with locally advanced or metastatic anaplastic, differentiated or medullar thyroid~     carcinoma.~   "
232676|NCT00510627|"~     The purpose of this study is to determine whether patients treated with Radiofrequency~     Ablation (RFA) in conjunction with chemotherapy have a better overall survival rate than~     patients treated with chemotherapy alone.~   "
232677|NCT00510614|"~     This research study is being done to evaluate the use of an oral (by mouth) medication called~     tinidazole to initially treat BV and then to see if additional treatment with tinidazole~     keeps women from getting this infection back within 3 months. Tinidazole is currently~     approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis~     (BV).~      This study will evaluate the use of tinidazole to treat a woman's current BV infection and~     then will look at using tinidazole as a suppressive treatment (taking medication regularly to~     attempt to decrease the bad bacteria from growing back). The suppressive treatment phase~     will include using tinidazole twice a week compared to using placebo twice a week and then~     following women for recurrence of BV. The purpose of this study is to determine if tinidazole~     suppression will prevent BV from coming back within 3 months of treatment.~      The investigators hypothesize that women with a history of recurrent bacterial vaginosis who~     are randomized to a suppressive regimen (a dose of medication given on a regular basis to~     attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have~     lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared~     to those women randomized to placebo.~   "
232678|NCT00510601|"~     A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive~     Heart Failure.~      Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will decrease~     workload on the heart and improve symptoms associated with the progression of Congestive~     Heart Failure~   "
232679|NCT00510588|"~     Chronic inflammatory activation in fat tissue can be the link between adiposity and an~     increased risk for atherosclerosis. Aim of the study is to investigate how molecular~     alterations in fat tissue can be influenced by regular physical exercise training alone or in~     combination with a medical therapy (Glitazon or Metformin) in obese patients with stable CAD~     and impaired glucose tolerance.~   "
232680|NCT00510575|"~     There are two rod sizes routinely used for the correction of juvenile and adolescent~     idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no~     scientific evidence supporting the superiority of one size rod relative to the other. This~     study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the~     6.35mm spinal instrumentation rods.~   "
232681|NCT00510562|"~     It is the purpose of this study to attempt to determine if there is an immediate, measurable~     change in visual function as a direct result following a session of cranial osteopathic~     manipulation.~   "
232682|NCT00510549|"~     As the influence of type of dialysis on survival of end stage renal disease (ESRD) patients~     remains unanswered, the present study is designed (randomized, prospective, multicenter,~     interventional) to assess clinical outcomes, and compare mortality, morbidity, Quality of~     Life (QOL) and cost effectiveness between maintenance In-center Hemodialysis (ICHD) and~     Continuous Ambulatory Peritoneal dialysis (CAPD). These data will ultimately bring clarity on~     whether or not any difference in patient survival exists between the two modalities.~      In order to test the feasibility of patients' willingness to be randomized to two different~     modality groups and retained in the randomized group, a pilot study is planned before the~     conduct of a main study.~      This pilot study comprises of a 6 months study, plus a 6 months observation if there is~     possibility to switch the patients into the main study.~      All ESRD patients requiring dialysis treatment within 8 weeks after a pre-study visit will be~     recorded in each site. Patients who provide written inform consent for collecting relevant~     information will be screened using certain inclusion/exclusion criteria. Eligible patients~     will undergo a standardized education regarding ESRD and treatment options. Thereafter the~     patient will be required to provide a second inform consent allowing for randomization and~     entrance into the study. Eligible patient will be randomized to either PD or HD treatment.~      The patients will be followed for a period of 6 months, during which patients will be treated~     with PD or HD as prescribed at each site, while meeting the dialysis adequacy and other~     indicators. For the first 3 months monthly visits are required, after which an every 3 months~     visit is planned.~      In this pilot study, the main objective is to assess the willingness of ESRD patients to be~     randomized to either PD or HD treatment; thereby determining if an adequate number of~     eligible patients can be recruited for a future large-scale study.~   "
232683|NCT00510536|"~     The purpose of this study is to evaluate tolerability and effectiveness of conventional~     treatment for mild to moderate arthritic or arthralgic symptoms while subjects are being~     treated with efalizumab for psoriasis.~   "
232684|NCT00510523|"~     The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy~     (WBV) on balance in participants with multiple sclerosis (MS) related balance deficits as~     measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke~     Expanded Disability Status Scale (EDSS) and the Berg Balance Score.~   "
232685|NCT00510510|"~     This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and~     200 µg once a day, compared to placebo in patients with moderate or severe Chronic~     Obstructive Pulmonary Disease (COPD).~   "
232686|NCT00510497|"~     This study aims to look at the safety and tolerability of immunization with dendritic cell~     vaccine prepared using the patient's own cells and virus. It also aims to explore the~     virologic efficacy of the vaccine as determined by a decrease in the viral load 12 weeks~     after analytic treatment interruption.~   "
232687|NCT00510484|"~     This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat~     and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.~   "
232721|NCT00510042|"~     The objective of this study is to assess the clinical presentation, the treatment and the~     complications of the disease and treatment in moderate and severe von Willebrand disease.~     Another goal is to investigate the influence of von Willebrand disease on quality of life.~   "
232688|NCT00510471|"~     The treatment being investigated is a patient- and tumor-specific therapy known as a~     personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a~     person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together~     with the personalized active immunotherapy because it may increase the immune system's~     response and, therefore, aid in the effect of the personalized active immunotherapy.~      This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma~     and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile~     have been seen to date in these studies.~   "
232689|NCT00510458|"~     Total hip replacement surgery is considered to be a very successful surgical procedure for~     the treatment of degenerative joint disease. The purpose of the study is to evaluate a large~     size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low~     Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3®~     polyethylene (plastic) inserts and will be compared with a historical control. Study~     Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head~     is no worse than 0.08 mm wear per year at 5 years post-surgery.~   "
232690|NCT00510445|"~     The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of~     GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to~     patients with advanced or metastatic non-small cell lung cancer.~   "
232691|NCT00510432|"~     An increased number of patients with heparin-induced skin lesions is reported in the~     literature. Heparin-induced skin lesions may result from either occlusion of cutaneous~     vessels in patients suffering from autoimmune HIT or from a type IV allergic reaction~     (delayed type hypersensitivity (DTH) response). However, the incidence and nature of~     heparin-induced skin lesions has not been determined in a prospective investigation.~      To address this open issue is the goal of this ongoing, so far monocenter, clinical~     investigation.~   "
232692|NCT00510419|"~     The purpose of this research study is to evaluate an investigational auto-injector system for~     delivering sumatriptan under the skin for a single migraine attack.~      The study could take approximately 5 weeks and will include about 3 office visits to the~     study doctor, the patient will be contacted every 2 weeks until the patient experiences a~     migraine and uses the auto-injector. The last visit will be done by a telephone follow-up~     call.~   "
232693|NCT00510406|"~     The study will examine the efficacy,safety and tolerability of combination therapy of~     tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin~     in the treatment of males with LUTS associated with BPH.~   "
232694|NCT00510393|"~     The Destiny trial compares the use of bare metal stent systems with drug eluting stent~     systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia.~     It will be investigated whether there is a difference in 12 month angiographic patency of the~     stented area using the 2 different stent systems.~   "
232695|NCT00510380|"~     This study is carried out to discover if a baby with restricted growth in the womb is subject~     to specific fetal programming which predisposes to the metabolic~     syndrome(diabetes,hypertension,heart disease) in adulthood.We have elected to first study~     this condition in Chinese population in Singapore with the eventual plan of studying all~     ethnic groups. This is important for understanding the molecular basis of adult-onset disease~     such as diabetes, identifying children at risk of developing this disease in future and~     targeting specific strategies for intervention and disease prevention.~      Intrauterine fetal programming is effected through epigenetic changes similar to those~     previously identified in animal studies. The epigenetic markers can be found in growth~     restricted Chinese pregnancies in the local population.~   "
232696|NCT00510367|"~     The goal of this clinical research study is to learn the results of multimodality~     (chemotherapy, surgery and radiation therapy) treatment of primary breast cancer that occurs~     at the same time as pregnancy. Researchers want to evaluate the outcome of labor and delivery~     as well as evaluate the long-term health outcomes of children exposed to chemotherapy while~     in their mother's womb.~   "
232697|NCT00510354|"~     The purpose of this multicenter, single-arm, Simon two-stage, phase II trial is to determine~     the efficacy and safety of everolimus in combination with Imatinib mesylate in patients with~     previously treated, histologically proven GIST whose disease has recurred or progressed while~     receiving 400 mg/day of Imatinib mesylate at any time during at least a 2 months' treatment~     period.~   "
232698|NCT00510341|"~     Self-care behaviors are decisions and actions that people can take to improve their health or~     cope with a health problem. It is important for people with long-term illnesses to develop~     and maintain effective self-care behaviors. This study will evaluate the usefulness and~     practicality of the Collaborative Management in Pediatrics (CMP) program, which is a training~     program developed to encourage pediatric resident doctors to promote self-management of~     illness and behavior change among children with asthma or obesity and their families.~   "
232699|NCT00510328|"~     The purpose of this study is to determine the effects of whole body vibration therapy on~     muscle firing patterns as measured by EMG analysis.~   "
232700|NCT00510315|"~     The purpose of this study is to better understand why some women who survived cancer or a~     related illness later develop diabetes, problems with their cholesterol, or other problems~     that may lead to heart disease. Because these problems may be related to treatment with total~     body irradiation and a stem cell transplant, the investigators will compare the rates of~     obesity, cholesterol problems, and diabetes between women who were treated with total body~     irradiation and a stem cell transplant and women who were not.~      The amount and location of fat stores in the abdomen is more important than overall weight or~     total body fat in the development of diabetes and cholesterol problems. In general, fat can~     be stored in several areas in the abdomen: around the organs (visceral fat), under the skin~     (subcutaneous fat), and in the liver (liver fat). People with higher amounts of fat around~     the organs (visceral fat), even those with a normal weight, are more likely to become~     diabetic or have high cholesterol. The amount of fat in each of these areas can be measured~     with an abdominal magnetic resonance imaging (MRI).~      In this study, the investigators will use blood tests, height, weight, waist circumference,~     blood pressure measurements, and an abdominal MRI to evaluate for several risk factors of~     heart disease, including cholesterol problems, diabetes and pre-diabetes, elevated blood~     pressure, and increased abdominal fat.~   "
232701|NCT00510302|"~     Primary Objectives:~        -  To conduct semi-structured interviews with melanoma patients and family members to~          collect descriptive information on their UVR exposure, UVR exposure-reduction practices,~          melanoma early detection practices, knowledge, psychosocial variables related to~          melanoma risk-reduction (e.g., self-efficacy, norms, and expectations), and experiences~          surrounding the diagnosis of melanoma in the family. Melanoma patients and family~          members with children will be asked about the UVR exposure and UVR exposure-reduction~          practices of their children, and parental practices to reduce UVR exposure among~          children.~        -  To develop behavioral and attitudinal questionnaires based on data collected during~          semi-structured interviews, and evaluate the appropriateness of these questionnaires~          using cognitive interviewing techniques.~        -  To develop tailored messages aimed at promoting strategies to reduce UVR exposure (e.g.,~          wearing protective clothing, minimizing midday UVR exposure, minimizing duration of UVR~          exposure, using shade and sunscreen, avoiding sun lamps, and avoiding intentional~          tanning) and improving adherence to surveillance and screening guidelines. Messages will~          be developed to correspond to responses to questionnaire items.~        -  To assess tailored messages for their relevance, appropriateness, attractiveness and~          appeal, credibility, and perceived behavioral impact among melanoma patients and their~          family members.~   "
232702|NCT00510289|"~     The purpose of this study is to evaluate the efficacy of sorafenib in patients with~     Myelodysplastic Syndrome (MDS). Eligible subjects will receive Sorafenib administered at~     400mg orally twice a day, given on days 1-28 of a 28-day cycle. Patients will be evaluated~     for hematological response after 2 cycles and then every 3 cycles thereafter for a maximum of~     5 years from study entry. If a patient achieves a complete response they may receive an~     additional 6 cycles of therapy beyond documentation of complete response unless unacceptable~     toxicity occurs. For patients with partial response, hematological improvement or stable~     disease they will continue treatment until relapse, progression of disease, or unacceptable~     toxicity occurs.~   "
232703|NCT00510276|"~     This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity~     disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults.~      A gatekeeper strategy will be employed for sequentially testing the secondary objectives.~      This study also has an observational community sample arm in which patients will complete all~     the efficacy measurements via web-based self reporting.~   "
232704|NCT00510263|"~     The main objective of this study is to study the effects of prednisolone and valaciclovir,~     with equal importance, compared to placebo for the treatment of Bell´s palsy. The combination~     of prednisolone and valaciclovir will also be studied.~   "
232705|NCT00510250|"~     This will be a multi-institution, single-arm, open-label, phase I/II trial. Eligible patients~     will have pathologically-proven T1b-3b, N0/1, M0 epithelial carcinoma of the cervix. We~     hypothesize that sorafenib in combination with chemotherapy and radiotherapy may have~     anti-tumor activity in patients with cervical cancer. Sorafenib has not previously been~     combined with conventional RT-CT to treat cervix cancer.~   "
232706|NCT00510237|"~     This study will pilot test an HIV intervention for newly diagnosed youth (diagnosed for less~     than 15 months) to assess its acceptability and feasibility preliminary to and leading up to~     a full-scale, randomized trial. The general focus of the intervention is to aid in the~     psychosocial adjustment of adolescents who have recently been diagnosed with HIV.~   "
232707|NCT00510224|"~     This is an open label, single center Phase II trial of Sandostatin LAR in patients with~     hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg~     intramuscularly every 28 days. Patients will be treated until the time of disease~     progression, unacceptable toxicity or withdrawal of consent. The study will require 27~     evaluable patients.~   "
232708|NCT00510211|"~     The primary objective of this study is to assess the proportion of schizophrenic patients and~     the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment~     in outpatient, ambulatory or community settings~   "
232709|NCT00510198|"~     The purpose of the PRECEDE-HF study is to collect data to compare patients whose heart~     failure is managed using Cardiac Compass with OptiVol (which is a tool in the device that~     records information about the heart that doctors can use to help treat their heart disease)~     combined with standard treatment methods (Access Group) to patients whose heart failure is~     managed by standard treatment methods only (Control Group). This comparison will show if the~     additional monitoring provided by Cardiac Compass with OptiVol delays the time patients are~     first admitted to hospital for heart failure or delays the time to death.~   "
232710|NCT00510185|"~     A randomized study comparing an early aggressive with an initially conservative strategy in~     patients >74 y.o. with non-ST-elevation acute coronary syndrome.~      This study had generated a secondary one:~      Causes of death in elderly patients with Non-ST-Elevation Acute Coronary Syndrome;~     predictors of in-hospital and follow-up death~   "
232711|NCT00510172|"~     We hypothesised that intravenous infusion of PGI2 induced headache or migraine and cranial~     vasodilatation in migraineurs.~   "
232712|NCT00510159|"~     The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP~     (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian~     children. The nul-hypothesis in this study is that the combination of As+SMP is more~     effective than praziquantel in the treatment of S. haematobium infected children.~   "
232713|NCT00510146|"~     The purpose of this study is to assess whether olanzapine is superior to placebo in patients~     with bipolar depression.~   "
232714|NCT00510133|"~     This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy~     with GRNVAC1 in patients with AML.~   "
232715|NCT00510120|"~     This study will evaluate the effectiveness of two different psychosocial therapies, parent~     management training and collaborative problem solving, in treating children with~     oppositional-defiant disorder.~   "
232716|NCT00510107|"~     To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin~     and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The~     primary endpoint will be the response rate.~   "
232717|NCT00510094|"~     This study will evaluate the effectiveness of a school-based social cognitive group treatment~     in reducing aggression (bullying) among relationally aggressive urban African American girls.~   "
232724|NCT00510003|"~     The purpose of this study is to assess the efficacy and safety of pimecrolimus cream 1% in~     relation to the improvement of pruritus in pediatric patients (2- to 11- year-old) with mild~     to moderate atopic dermatitis.~   "
232725|NCT00509990|"~     An open-label, multicenter study, of long term management to evaluate effectiveness,~     tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate~     atopic dermatitis in a daily practice~   "
232726|NCT00509977|"~     The purpose of this study is to determine the efficacy of light treatment and laser treatment~     for melasma. These treatment options have not been thoroughly explored in the treatment of~     melasma. By studying the effect of different treatments, a better treatment plan may be~     developed for people with melasma.~   "
232727|NCT00509964|"~     Patients with recurrent or metastatic gastric cancer can benefit from palliative~     chemotherapy. However, over half of patients with metastatic gastric cancer who received~     chemotherapy failed to achieve response and even in these responders, the duration of~     responses was as short as a few months. Patients with metastatic gastric cancer who fail to~     respond or have relapse after first line chemotherapy have a grim prognosis and a standard~     salvage treatment is not available.~      We designed this phase II trial to determine the efficacy and safety of irinotecan~     monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.~   "
232728|NCT00509951|"~     This study will compare the effectiveness of two types of cognitive behavioral therapy,~     one-session exposure treatment and family-enhanced one-session exposure treatment, in~     treating children with specific phobias.~   "
232729|NCT00509938|"~     The safety and tolerability of hLF 1-11 has to be established first in HSCT recipients who~     are at risk of developing, but have not yet developed, infectious complications due to~     invasive fungal disease. These patients are different from healthy volunteers because they~     have received myeloablative treatment which not only arrests haematopoiesis resulting in~     neutropenia but also induces mucosal barrier injury both of which predispose to infections~     which typically occur during the week after transplant. It is therefore essential to know~     that hLF 1-11 is when given during neutropenia and mucosal barrier injury before infections~     ensue~   "
232730|NCT00509925|"~     This trial is conducted in Europe. The purpose of this trial is to investigate if there is~     any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in~     patients with type 1 diabetes, whilst taking two different, commercially available insulins~     for the treatment of their diabetes.~   "
232731|NCT00509899|"~     To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424),~     administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera~     Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).~   "
232732|NCT00509886|"~     The purpose of this study is to assess the effectiveness of the prescription treatment~     compared to the non-prescription treatment. It is hypothesized that the prescription~     treatment will have a significantly greater effect than the non-prescription treatment on~     decreasing excess sweating.~   "
232733|NCT00509873|"~     The study will determine the safety and efficacy of gatifloxacin eye drops in patients with~     bacterial conjunctivitis~   "
232734|NCT00509860|"~     Primary Objectives:~        1. To determine the efficacy of the topoisomerase I (topo I) inhibitor irinotecan,~          delivered via a low-dose protracted schedule to patients with advanced sarcoma.~        2. To determine the toxicity profile of irinotecan, using a protracted schedule, in this~          pretreated patient population.~   "
232735|NCT00509847|"~     The purpose of this study is to establish the tolerability of treatment with human~     lactoferrin 1-11 peptide (hLF1-11) administered intravenously as a single dose given for 10~     consecutive days, to patients with bacteremia due to staphylococcus epidermidis.~   "
232736|NCT00509834|"~     This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and~     early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients~     with invasive Candida infection.~   "
232737|NCT00509821|"~     The purpose of the protocol is to induce a novel radiochemotherapy with enzastaurin as~     first-line treatment regimen in glioblastoma: Patients with active, unmethylated MGMT~     promoter will be treated with enzastaurin before, concomitant, and after radiotherapy to~     determine safety and PFS at 6 months (PFS-6) in phase II.~   "
232738|NCT00509808|"~     This is a multinational trial, aimed at testing the safety and performance of a~     electrostimulating device (GenNarino) to treat dry mouth, over one year. The design is as~     follows:~        -  Multi-center, double blind, sham (placebo) controlled, about 10 xerostomia patients per~          center~        -  Patients receive a GenNarino (and its remote control) that is programmed for one month~          sham and one month active mode (the order of which is randomly assigned), and thereafter~          9 months at the active mode (divided in period of 3 months, the order of each is~          randomly assigned at wearing GenNarino for 1, 5 or 10 minutes at a time).~      Study hypothesis: Gennarino will lead to significant symptomatic improvement~      - At the clinic: monthly examinations at the first 2 months, and then every 3 months,~     including whole saliva collection and questionnaire; at the first visit impression taking for~     GenNarino preparation~   "
232739|NCT00509795|"~     This study is a phase 3, double-masked, randomized, study of the efficacy and safety of VEGF~     Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200~     patients will be randomized in the US and Canada.~   "
232740|NCT00509782|"~     Primary Objectives:~        1. To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when~          administered intravenously once a day for 5 consecutive days every 4 weeks in subjects~          with advanced solid tumors.~        2. To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once~          a day for 5 consecutive days every 4 weeks.~      Secondary Objective:~      1. To determine the anti-tumor effects of ZIO-101.~   "
232741|NCT00509769|"~     This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab~     emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal~     growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).~   "
232742|NCT00509756|"~     The primary purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of a single dose of FXR-450 in healthy Japanese men.~   "
232743|NCT00509743|"~     The purpose of this study is to assess the effects of age, weight, and body composition on~     the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium~     (DIC075V) in adult volunteers.~   "
232744|NCT00509730|"~     To test the value of preoperatively performed urodynamics with regard to outcome of surgery~     for stress urinary incontinence (SUI) and to examine whether not performing urodynamics~     preoperatively is more cost effective than performing urodynamics preoperatively using the~     non-inferiority assumption.~   "
232745|NCT00509717|"~     The purpose of this study is to determine the effectiveness of maximal support of community~     pharmacies to implement a pharmaceutical care model for improving underprescription and~     treatment persistence regarding lipid-lowering medication in patients with cardiovascular~     disease.~   "
232746|NCT00509704|"~     The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and~     necrosis in patients with metastatic renal cell cancer.~   "
232747|NCT00509691|"~     RATIONALE: Vaccines may help the body build an effective immune response to kill~     cytomegalovirus infections.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients who have undergone a donor stem cell transplant and have cytomegalovirus~     infection that has not responded to therapy.~   "
232748|NCT00509678|"~     The purpose of this study is to help determine the effectiveness of rituxan (with or without~     methotrexate) in the treatment of psoriatic arthritis.~   "
232749|NCT00509665|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     doxorubicin works in treating patients with recurrent or progressive head and neck cancer.~   "
232750|NCT00509652|"~     Primary hemochromatosis is the most frequent hereditary condition in Scandinavia. The~     condition may result in serious organ damage which can be prevented by therapy, but only few~     patients develop such organ damage. The optimal treatment, therefore, is still a matter of~     discussion Prevention of organ damage has traditionally been accomplished by drawing of full~     blood (phlebotomy), which has to be frequently repeated during the initial phase and then~     continued indefinitely as a maintenance treatment. The removed amount of iron may be~     increased two- or threefold for each procedure by using modern equipment for selective~     removal of red blood cells (red cell apheresis). Possible drawbacks of this technique may be~     higher costs, prolonged time for each therapeutic procedure, and certain requirements to the~     patients. The possible advantages are the reduced number of therapeutic procedures and less~     strain for the patient. No larger, randomized study has been published in order to determine~     which method should be preferred.~      This study is a controlled trial in which participating patients are asked to be randomized~     to red cell apheresis or traditional phlebotomy. Each group will be followed by means of~     well-defined assessments in order to explore possible advantages and disadvantages of each~     method in order to establish what type of treatment should be recommended.~   "
232751|NCT00509639|"~     The purpose of this study is to compare changes in Perianal Crohn's Disease following use of~     locally applied 10% metronidazole ointment and a placebo.~   "
232752|NCT00509626|"~     RATIONALE: Physical activity may prevent or reduce weight gain in women receiving~     chemotherapy for early stage breast cancer.~      PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it~     works compared with usual care to prevent or reduce weight gain in women with stage I or~     stage II breast cancer undergoing chemotherapy.~   "
232753|NCT00509613|"~     The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for~     combination therapy in subsequent phase 2 trials.~   "
232754|NCT00509600|"~     Primary Objectives:~      1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front~     phase II window in newly diagnosed or relapsed JMML.~      1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic~     basis of Juvenile Myelomonocytic Leukemia (JMML) [mutations in NF1, Ras, SHP2] or levels of~     TNFa.~      1.3 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and~     other cytokines by ELISA and bioassay and improves blood counts.~      1.4 Estimate the two year event free survival and overall survival in JMML patients following~     etanercept and allogeneic hematopoietic stem cell transplantation.~   "
232755|NCT00509587|"~     This phase II trial is studying how well giving pazopanib works in treating patients with~     recurrent or metastatic invasive breast cancer. Pazopanib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the~     tumor.~   "
232756|NCT00509574|"~     The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played~     an important role in lipid-lowering therapy and reduction of cardiovascular risks. However,~     it has been observed that the response to statin therapy varies from patient to patient, and~     gene polymorphism could have contributed to the variation.~   "
232757|NCT00509561|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and capecitabine, work in different~     ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays~     to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not~     yet known whether giving cisplatin together with capecitabine and radiation therapy is more~     effective with or without cetuximab in treating esophageal cancer.~      PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving~     cisplatin together with capecitabine, radiation therapy, and cetuximab works compared with~     giving cisplatin, capecitabine, and radiation therapy without cetuximab in treating patients~     with esophageal cancer.~   "
232832|NCT00508573|"~     The goal of this study is to create a registry of information about women who have or are at~     risk for Lynch syndrome, in order to study gynecologic cancer risks.~      This is an investigational study. Up to 1000 patients will take part in this study. All~     patients will be enrolled at MD Anderson.~   "
247511|NCT00313274|"~     The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine~     (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative~   "
232758|NCT00509548|"~     Wet age-related macular degeneration (AMD) is caused by the formation and growth of abnormal~     blood vessels (angiogenesis) in the retina. The new blood vessels have fragile walls and can~     leak fluid into the retina. The build-up of fluid (edema) under the macula can distort vision~     or cause vision loss. TG100801 is a topical (eye drop) therapy that has been shown to inhibit~     ocular angiogenesis, vascular leak, and inflammation in laboratory studies. The primary~     purpose of this pilot study is to evaluate the ability of topical administration of TG100801~     to reduce the amount of fluid in the retina in patients with AMD following 30 days of~     treatment. An additional objective is to evaluate the safety of TG100801 in patients with~     AMD.~   "
232759|NCT00509535|"~     Atopic dermatitis (AD), a chronic and relapsing inflammatory skin disease, is associated with~     elevated IgE levels and Th2 responses. It is currently believed that non-pathogenic bacteria~     modulate intestinal immune responses avoiding the development of allergic diseases. However,~     effects of oral probiotics on AD could not be reproduced in all studies and direct~     immuno-modulation of the skin associated immune response by non-pathogenic bacteria has not~     been investigated so far. We therefore performed a double blind placebo controlled clinical~     study on the effects of an ointment containing 5% extracts of the non-pathogenic bacteria~     Vitreoscilla filiformis on AD. Seventy-five AD patients (6-70 years of age) were randomized~     to receive either Vitreoscilla filiformis ointment 5% or vehicle ointment daily for 30 days.~     Efficacy evaluations, including the Score of Atopic Dermatitis (SCORAD), transepidermal~     water loss, assessement of microflora, and the patient assessment of itch and loss of sleep~     occurred at baseline, day 15, and day 29.~   "
232760|NCT00509509|"~     Objectives:~        -  To screen population with high risk for breast cancer~        -  To promote the concept and importance of surveillance mammography~        -  To find out the incidence of breast cancer in population who are in high risk for breast~          cancer~        -  To collect blood samples for molecular analysis~   "
232761|NCT00509496|"~     Background:~        -  Human peripheral blood lymphocytes have been engineered to express a T-cell receptor~          (TCR) that recognizes a blood type, human leukocyte antigen (HLA-A*0201) derived from~          the gp100 protein. A retroviral vector was constructed that can deliver the TCR to~          cells.~        -  This gene-engineered cell is over 10 times more reactive with melanoma cells than is the~          melanoma antigen recognized by T-cells (MART-1) TCR that resulted in tumor shrinkage for~          two patients with metastatic melanoma.~      Objectives:~        -  To determine whether an anti-melanoma protein receptor can be put in cells removed from~          patients' tumors or blood and then reinfused, with the purpose of shrinking tumors.~        -  To evaluate safety and effectiveness of the treatment.~      Eligibility:~        -  Patients 18 years of age or older with metastatic cancer melanoma (cancer that has~          spread beyond the original site).~        -  Patient's leukocyte antigen type is HLA-A*0201.~      Design:~      -Patients undergo the following procedures:~        -  Leukapheresis (on two occasions). This is a method of collecting large numbers of white~          blood cells. The cells obtained in the first leukapheresis procedure are grown in the~          laboratory, and the anti-gp100 protein is inserted into the cells using an inactivated~          (harmless) virus in a process called retroviral transduction. Cells collected in the~          second leukapheresis procedure are used to evaluate the effectiveness of the study~          treatment.~        -  Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1~          hour for 2 days to suppress the immune system so that the patient's immune cells do not~          interfere with the treatment.~        -  Treatment with anti-gp100. Patients receive an IV infusion of the treated cells~          containing anti-gp100 protein, followed by infusions of a drug called IL-2~          (aldesleukin), which helps boost the effectiveness of the treated white cells.~        -  Patients are given support medications to prevent complications such as infections.~        -  Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue).~        -  Patients are evaluated with laboratory tests and imaging tests, such as CT scans, 4 to 6~          weeks after treatment and then once a month for 3 to 4 months to determine the response~          to treatment.~        -  Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.~   "
232762|NCT00509483|"~     Background: Preadministration of recombinant human thyrotropin (rhTSH) increases the amount~     and homogeneity of thyroid radioiodine uptake, and when used as an adjuvant can augment the~     efficiency of 131I therapy by allowing multinodular goitre (MNG) volume reduction.~      Objective: The investigators aimed to assess low-dose rhTSH-aided fixed-activity radioiodine~     therapy outcome in MNG patients.~      Design: This was a long-term (36 months) observational study. Methods: The investigators~     measured 24 h thyroid radioiodine uptake (RAIU) of 1.4 µCi (0.5 MBq) of 131-iodine at~     baseline and 24 h after intramuscular injection of 0.1 mg rhTSH in 42 patients (aged 42-80~     years) who subsequently received 30 mCi 131-iodine 24 h after an identical rhTSH injection.~     Urinary iodine was measured at baseline and at 3 months after following a low iodine diet.~     TSH, free thyroxine (FT4), T3 (T3) and thyroglobulin (TG) were measured at baseline, 24 h, 48~     h, 72 h, 168 h, one month, 3, 6, 9, 12, 18, 24 and 36 months after therapy. Thyroid volume~     was assessed by computer tomography at baseline and every 6 months thereafter.~   "
232763|NCT00509470|"~     The purpose of this study is to compare depressor effect and safety between combination~     therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive~     patients.~   "
232764|NCT00509457|"~     To examine the safety and efficacy of telomerase peptide vaccination ( stimulation of the~     immune system) in patients with NSCLC after having been treated with conventional therapy~     with radiotherapy and docetaxel as a radiosensitizer.~   "
232765|NCT00509444|"~     The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6~     sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ,~     Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration (September~     15, 2006 to September 30, 2010). One goal of the demonstration is to reduce disparities in~     cancer treatment among seniors from U.S. racial and ethnic minority populations. Each site~     will focus on a specific racial/ethnic minority group, and collaborate with CMS in project~     implementation. A Core questionnaire, the Cancer Screening Assessment (CSA) will be~     administered at baseline to all participants in the demonstration. Participant~     identification, randomization, and intervention implementation will be standardized across~     sites.~      Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in~     collaboration with the Baltimore City Community Health Coalition is designed to address~     persistent disparities in breast, cervix, colon/rectum, prostate and lung cancer treatment.~      Primary Objective: Conduct A CONTROL RANDOMIZED TRIAL within a randomized control~     demonstration project (N = 200) to compare the efficacy of 2 interventions that differ in~     intensity to improve continuity and outcomes of care among African Americans seniors. Among~     African American seniors, compared to a less intensive intervention (general information and~     educational materials), does the addition of facilitation services delivered by a health~     coordinator result in a greater improvement in adherence to recommended treatment among those~     diagnosed with breast, cervix, colon/rectum, prostate, or lung cancer?~      Study Population: We will recruit African Americans, age 65 years or older, and currently~     enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors represent 13% of its~     population, and account for 68% of the City's cancer deaths. Among these seniors, 96% have~     Medicare Parts A and B, 54.5% have income levels at less than 250% of the federal poverty~     guideline, and 55.6% are African American.)~      The trial consists of individuals diagnosed with breast, cervical, colorectal, prostate, or~     lung cancer. Eligible participants will respond to a baseline questionnaire, the Cancer~     Screening Assessment (CSA). They will then be randomized to receive a less intensive or more~     intensive intervention. The less intensive group will receive general information about~     cancer and Medicare covered services and instructions to discuss the information with their~     primary care doctor. The more intensive group will receive the same information as the less~     intensive group receives, plus tailored facilitation services delivered by a nurse-supervised~     community health worker. The primary outcome variable for the trial will be the difference~     between randomized groups in adherence to treatment for breast, cervix, colon/rectum,~     prostate and lung cancer.~      A community advisory committee will guide all aspects of the study and will include important~     stake holders (both public and private sectors), representatives from the Baltimore City~     Community Health Coalition, the Baltimore City Department of Health, the Maryland Department~     of Health and Mental Hygiene, community leaders, consumers, health care providers~     (physicians, oncologists, nurse practitioners, physician assistants, nurses, social workers,~     pathologists) and academicians.~   "
232766|NCT00509431|"~     RATIONALE: Erlotinib and sirolimus may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when~     given together with sirolimus and to see how well they work in treating patients with~     recurrent malignant glioma.~   "
232767|NCT00509418|"~     The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in~     combination with diet and exercise improve the histological results (steatosis,~     necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24~     weeks of treatment.~   "
232768|NCT00509405|"~     Hypothesis: Neutralization of acid production induced by the Western diet with oral~     administration of potassium citrate increases bone mineral density and bone mass as well as~     skeletal muscle mass and strength in elderly people (> 65y).~   "
232769|NCT00509392|"~     The objective of this post-market study is to compare the post-procedure recovery between two~     types of minimally invasive catheter treatments for venous disease in the Great Saphenous~     Vein.~   "
232770|NCT00509379|"~     The promising activity of Bortezomib as single agent in low grade lymphoma patients in small~     studies has led to a number of larger multicenter trials with Bortezomib in combination with~     Rituximab in mantle-cell lymphoma, follicular lymphoma and marginal zone lymphoma.~   "
232833|NCT00508560|"~     This study examines the use of contingent incentives to increase attendance at smoking~     cessation treatment sessions by smokers with schizophrenia and other psychoses who want to~     quit smoking. We hypothesize that participants randomized to receive contingent rewards for~     group attendance will attend more treatment sessions than those in the control group.~   "
232771|NCT00509366|"~     In this trial, subjects with chemo-naive advanced non-small cell lung cancer (NSCLC) were~     assigned to chemotherapy using a genomic-based predictor for platinum sensitivity. After an~     amendment dated 1/25/2010, subjects with squamous cell NSCLC sensitive to cisplatin received~     cisplatin/gemcitabine and if resistant to cisplatin received docetaxel/gemcitabine. Subjects~     with non-squamous cell NSCLC sensitive to cisplatin received cisplatin/pemetrexed and if~     resistant to cisplatin received pemetrexed/gemcitabine. The primary objective of this trial~     was to prospectively validate the genomic-based prediction model through separate evaluation~     of the one-year progression-free survival (PFS) of the cisplatin-sensitive and~     cisplatin-resistant cohorts. Secondary objectives included: assessment of overall time to~     progressive disease, quality of life and evaluation of drug sensitivity patterns of cisplatin~     and pemetrexed.~   "
232772|NCT00509353|"~     RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIGB), may carry~     radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such~     as irinotecan and vincristine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving iodine I 131 MIGB~     together with irinotecan and vincristine may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 MIGB~     when given together with irinotecan and vincristine in treating young patients with resistant~     or relapsed high-risk neuroblastoma.~   "
232773|NCT00509340|"~     This study will compare the effectiveness of a cognitive behavioral intervention versus usual~     clinic care in helping HIV infected adults with depression to take their HIV medications on~     schedule.~   "
232774|NCT00509327|"~     Postoperative bowel dysmotility is a frequent condition after colorectal surgery. The~     influence of colon stimulating laxatives have not been studied. This prospective, randomized,~     double blind, placebo controlled study assesses the influence of bisacodyl on postoperative~     bowel motility in patients undergoing elective colorectal surgery. The hypothesis of this~     trial was that bisacodyl has a beneficial effect on the duration of postoperative ileus.~   "
232775|NCT00509314|"~     The aim of this study is to survey melanocytes in the ability of self-assembly on~     biomaterials and functional analysis in vitro. Also, this study may provide a better way for~     treatment of vitiligo after understanding the functional aspects of melanocytes.~   "
232776|NCT00509301|"~     RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine~     131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor~     cells and deliver radiation directly to the center of the tumor mass while minimizing effects~     on normal tissues. Cotara® thus literally destroys the tumor from the inside out. This may~     be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.~      PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients~     with recurrent glioblastoma multiforme.~   "
232777|NCT00509288|"~     Background:~        -  Human peripheral blood lymphocytes have been engineered to express a T-cell receptor~          (TCR) that recognizes a blood type,HLA-A 0201 (human leukocyte antigen) derived from the~          gp100 protein. A retroviral vector was constructed that can deliver the T-cell receptor~          (TCR) to cells.~        -  Patients' cells will be converted into cells able to recognize and fight melanoma~          tumors.~      Objectives:~        -  To determine whether TCR-engineered lymphocytes can be put in cells removed from~          patients' tumors or blood and then reinfused, with the purpose of shrinking tumors.~        -  To evaluate safety and effectiveness of the treatment.~      Eligibility:~        -  Patients 18 years of age or older with metastatic cancer melanoma (cancer that has~          spread beyond the original site).~        -  Patient's leukocyte antigen type is HLA-A 0201.~      Design:~      -Patients undergo the following procedures:~        -  Leukapheresis (on two occasions). This is a method of collecting large numbers of white~          blood cells. The cells obtained in the first leukapheresis procedure are grown in the~          laboratory, and the anti-MART-1 protein is inserted into the cells using an inactivated~          (harmless) virus in a process called retroviral transduction. Cells collected in the~          second leukapheresis procedure are used to evaluate the effectiveness of the study~          treatment.~        -  Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1~          hour for 2 days to suppress the immune system so that the patient's immune cells do not~          interfere with the treatment.~        -  Treatment with anti-melanoma antigen recognized by T-cells (MART)-1. Patients receive an~          intravenous (IV) infusion of the treated cells containing anti-MART-1 protein, followed~          by infusions of a drug called IL-2 (aldesleukin), which helps boost the effectiveness of~          the treated white cells.~        -  Patients are given support medications to prevent complications such as infections.~        -  Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue).~        -  Patients are evaluated with laboratory tests and imaging tests, such as CT (computed~          tomography) scans, 4 to 6 weeks after treatment and then once a month for 3 to 4 months~          to determine the response to treatment.~        -  Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.~   "
232778|NCT00509275|"~     In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group~     study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately~     11 centres in the USA, Canada and Australia.~      The primary objective of the study is to assess the patient response to three W0027 regimens~     in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability~     and skin and nail pharmacokinetics to the three Albaconazole regimens.~   "
232779|NCT00509262|"~     The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose~     levels in participants with moderate or severe renal insufficiency.~   "
232780|NCT00509249|"~     This phase II trial is studying how well aflibercept works in treating patients with~     myelodysplastic syndromes. Aflibercept may be able to carry cancer-killing substances~     directly to myelodysplastic syndrome cells. It may also stop the growth of cancer cells by~     blocking blood flow to the cancer~   "
232781|NCT00509236|"~     The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in~     participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who~     do not have adequate glycemic control.~   "
232797|NCT00509028|"~     This study will include the patients who are Japanese children with bronchial asthma aged 5~     years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at~     about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of~     100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study~     D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with~     bronchial asthma in need of inhaled glucocorticosteroid treatment.~   "
232834|NCT00508547|"~     The purpose of this study is to further evaluate the safety of infliximab and ustekinumab in~     patients with plaque psoriasis, and other all forms of psoriasis (such as plaque psoriasis~     and psoriatic arthritis occurring together). The registry study will track the behavior of~     the disease in response to other therapies, such as other biologic drugs. The registry will~     also evaluate clinical outcomes; disease characteristics, including physician reported~     assessment of psoriatic arthritis (PsA); quality of life, and potential risks for patients~     who may receive standard therapies for psoriasis.~   "
232782|NCT00509223|"~     Obstructive Sleep Apnea (OSA) and type 2 diabetes mellitus are two prevalent medical~     conditions with significant associated cardiovascular and cerebrovascular morbidity and~     mortality. Research indicates that the prevalence of OSA is increased in diabetic patients~     when compared with normoglycemic patients and that OSA is independently associated with type~     2 diabetes. Further research suggests that effective treatment of the OSA with continuous~     positive airway pressure (CPAP) improves insulin responsiveness in both non-diabetic OSA~     patients and diabetic-OSA patients. We are proposing a clinical trial to evaluate the impact~     of 6 months of CPAP therapy on glycemic control in type 2 diabetic patients with OSA.~      The primary objective of this study is to assess the effectiveness of CPAP in improving~     glycemic control (HbA1c) in type 2 diabetic patients with newly diagnosed OSA. Secondary~     objectives of this study include: assessment of fasting and post prandial glucose,~     determination as to whether there are any biochemical markers for OSA in the type 2 diabetic~     population; assessment of any improvements in cardiovascular outcomes; evaluation of any~     improvement in quality of life. Patients with OSA will be randomized into one of two groups:~     either a CPAP treatment group or a non-treatment group. Patients will be followed at 3 months~     and 6 months with collection of various lab tests to assess glycemic control.~   "
232783|NCT00509210|"~     The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir~     following administration of multiple oral doses to subjects with moderate and severe hepatic~     impairment.~   "
232784|NCT00509197|"~     The efficacy of inhaled corticosteroids (ICS) in asthmatic subjects showing no sputum~     eosinophils is controversial. The broad aim of this study is to assess whether ICS alone or~     in combination with long-acting beta-2 agonists are an effective treatment in~     non-eosinophilic asthmatic subjects. Methods: The investigators will perform a randomized~     double-blind, placebo-controlled, multicenter study comparing the efficacy of ICS and placebo~     for 4 weeks followed by a 4-week open treatment period with ICS/salmeterol in steroid-naïve~     asthmatic subjects without sputum eosinophilia. The primary outcome will be the the Asthma~     Control Questionnaire (ACQ) score after four weeks of treatment by ICS or placebo.~      This study will determine whether or not non-eosinophilic asthmatic subjects respond to ICS~     and if they further benefit from the addition of a long-acting beta-2 agonists. This study~     will also determine whether or not the assessment of airway inflammation should be performed~     in every asthmatic patient in order to give the most appropriate treatment.~   "
232785|NCT00509184|"~     Combination of involved field radiotherapy for the control of macroscopic disease and CD20~     antibody Rituximab for the control of microscopic remainders in other regions in patients~     with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.~   "
232786|NCT00509171|"~     The purpose of this study is to determine the effect on the incidence of fat emboli when~     using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures~   "
232787|NCT00509158|"~     Malaria is responsible for over 2 million deaths each year. The development of an efficient~     vaccine would present by far the best solution for solving this disastrous situation.~     Liver-Stage-Antigen-3 (LSA-3) is an antigen that is mainly exhibited by Plasmodium falciparum~     sporozoites and liver-stage parasites. It is characterized by its remarkable antigenicity in~     humans with a wide range and a variety of B and T-lymphocyte epitopes, by its extremely high~     immunogenicity and by an excellent protective efficacy against sporozoite challenge in animal~     models. Therefore, PfLSA-3-rec is a promising candidate vaccine against P. falciparum in~     humans The aim is to screen two different formulations of the recombinant malaria vaccine~     PfLSA-3-rec, one adjuvated with aluminium hydroxide and one with Montanide Isa 720, by~     assessing the safety and immunogenicity (phase I) profile of each formulation in humans, as~     well as its protective efficacy following a sporozoite challenge (phase IIa).~   "
232788|NCT00509145|"~     Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as~     compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).~   "
232789|NCT00509132|"~     The purpose of this study is to evaluate the safety and tolerance of single intravenous~     (through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to~     each volunteer group throughout the study. Another purpose is to evaluate the~     pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues~     over time) of trodusquemine. Finally, this study will also determine whether trodusquemine~     has any effect on appetite, mood or behavior, and selective biomarkers (substances in your~     blood that may change in response to the study drug).~   "
232790|NCT00509119|"~     This is a study on how acute clinical state and final clinical outcome in patients with~     stroke (exclusive subarachnoid hemorrhage) relate to ICP/ABP-derived pressure waveform~     parameters recorded during intensive care management.~   "
232791|NCT00509106|"~     The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective~     in the treatment of community-acquired pneumonia in adults.~   "
232792|NCT00509093|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating~     patients with newly diagnosed acute myeloid leukemia who have received chemotherapy.~   "
232793|NCT00509080|"~     The purpose of this study is to determine if the use of BNP/NT-proBNP levels in the detection~     of early left ventricular dysfunction and damage may improve the timing of cardiac surgery~     and therefore the long-term management of asymptomatic patients with severe mitral~     regurgitation.~   "
232794|NCT00509067|"~     This study will evaluate the effectiveness of galantamine and CDP-choline in improving~     symptoms associated with schizophrenia.~   "
232795|NCT00509054|"~     Parastomal hernias are randomised to either a conventional stoma formed through the rectus~     anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay~     position.~   "
232796|NCT00509041|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with~     previously treated malignant mesothelioma.~   "
232819|NCT00508742|"~     This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine~     (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.~   "
232798|NCT00509015|"~     In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a~     tool for malaria control in 'exceptional conditions when conventional control strategies have~     failed'. Subsequently, MDA has received little attention until the introduction of~     artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria~     transmission by clearing the population of sexual stage parasites, gametocytes, prior to the~     transmission season. Gametocytes are essential for propagation of the disease and elimination~     of gametocytes will result in a reduction in malaria transmission. As a consequence, a~     successful MDA will reduce the burden of disease in a population and is expected to have~     little influence on the development of protective immunity in areas of low transmission~     intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That~     study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of~     artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible~     reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on~     malaria transmission, the incomplete coverage, the relatively high transmission intensity in~     the area and the migration of individuals between villages. Here, we propose to conduct an~     MDA study in an area of very low malaria transmission intensity in Tanzania. We use the~     highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..~   "
232799|NCT00509002|"~     The goal of this clinical research study is to learn if ZD1839 (Iressa®, gefitinib can help~     to shrink or slow the growth of advanced, recurrent, or metastatic salivary gland cancer. The~     safety of this drug will also be studied.~   "
232800|NCT00508989|"~     This study will determine whether niacin can improve blood flow in people with sickle cell~     disease, in which abnormal red blood cells interfere with blood flow to cause the disease~     symptoms. Niacin, a drug that has been used to increase HDL (good cholesterol) levels,~     improves blood flow in people without sickle cell disease. This study will see if it can do~     the same in people with the disease.~      Patients with sickle cell disease between 18 and 65 years of age may be eligible for this~     study.~      Candidates are screened with a medical history, physical examination, blood tests,~     echocardiogram and 6-minute walk test of exercise capacity.~      Participants have the following baseline blood flow studies:~        -  Flow-mediated dilation (FMD): An ultrasound picture of the artery in the forearm is~          obtained. A blood pressure cuff is then placed on the upper arm and inflated for 5~          minutes. After the pressure cuff is released, the ultrasound is repeated.~        -  Peripheral artery tonometry (PAT): A sensor is placed on the subject s finger. The~          sensor puts pressure on the finger and measures blood flow.~        -  Standard forearm blood flow test: Small tubes are placed in the artery of the forearm at~          the inside of the elbow. Saline is infused into one tube. Pressure cuffs are applied to~          the wrist and upper arm. A strain gauge (rubber band device) is placed around the~          forearm. When the cuffs are inflated, blood flows into the arm, stretching the strain~          gauge, and the flow measurement is recorded. Blood samples are collected from the tube~          in the artery to measure blood counts, proteins and other chemicals. At various times,~          small doses of the following drugs are administered through the tube in the vein:~             -  Sodium nitroprusside causes blood vessels to dilate and increases blood flow to the~               heart.~             -  Acetylcholine causes blood vessels to dilate and slows heart rate.~             -  LNMMA decreases blood flow by blocking the production of nitric oxide.~      Blood flow is measured after each dose of the different drugs. There are rest periods between~     injections of the different drugs. Pictures of the forearm are taken during the studies using~     an infrared camera and computer.~      -Drug Treatment. Participants are assigned to take three 4-week courses of niacin or placebo.~     They return to the Clinical Center at the following intervals from the time they start the~     test drug for followup:~        -  Weeks 2, 6 and 10: Brief medical history, review of medication side effects and blood~          tests.~        -  Weeks 4 and 8: Physical examination, brief medical history, review of medication side~          effects and blood tests, repeat FMD and PAT blood flow studies and 6-minute walk test.~        -  Week 12: Same as weeks 4 and 8 plus standard blood flow studies and echocardiogram.~   "
232801|NCT00508976|"~     The purpose of this study is to determine if pre-incisional lidocaine injection, instilled~     liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine~     injection is superior in post-operative pain control in laparoscopic bariatric surgical~     patients.~   "
232802|NCT00508963|"~     Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be~     treated with sodium stibogluconate (Pentostam).~   "
232803|NCT00508950|"~     The study will identify healthy adults who have been vaccinated against pneumococcus, and~     collect blood for the purpose of developing laboratory assays.~   "
232804|NCT00508937|"~     The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the~     hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can~     ameliorate insulin resistance in the absence of weight loss, and that this effect is~     independent of saturated fat content. Moreover, we will test whether such diets result in~     beneficial changes in total LDL cholesterol, small, dense LDL, and HDL cholesterol that are~     also independent of saturated fat intake.~   "
232805|NCT00508924|"~     This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the~     information on dose-response of argatroban in pharmacodynamic markers and to assess the~     anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in~     combination with dual antiplatelet therapy.~   "
232806|NCT00508911|"~     This study will be conducted in healthy female volunteers to investigate the effect of~     GW876008 on the pharmacokinetics of oral contraceptive pills.~   "
232807|NCT00508898|"~     Glomerulonephritis and renal failure represent one of the most life-threatening~     manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is~     often effective for the treatment of acute lupus nephritis, a significant proportion of~     patients show persistent proteinuria after resolution of the acute nephritic process, and~     develop progressive renal failure. There is preliminary evidence that calcitriol and other~     vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The~     investigators plan to conduct a randomized control study to evaluate the safety and efficacy~     of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients~     with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be~     recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function,~     lupus disease activity, serum and urinary inflammatory markers will be monitored. This study~     will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the~     treatment of SLE, which is a common and life threatening disease in young adults.~   "
232808|NCT00508885|"~     Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are~     insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of~     vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the~     use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma~     phosphorus levels in peritoneal dialysis patients versus placebo.~   "
232820|NCT00508729|"~     With multicenter randomized control clinical evaluation investigations, the effect of~     traditional Chinese medicine on gastrointestinal function recovery and nutrition support in~     early stage of severe acute pancreatitis (SAP) was evaluated, and the therapeutic effects,~     safety and indications assured. Drawing in latest research fruits at home and abroad, a~     clinical practical guideline would be formed, to be popularized all over China.~   "
232809|NCT00508872|"~     Objective:~        -  To evaluate the efficacy of the use of the combination of oxaliplatin, 5-fluorouracil,~          leucovorin and bevacizumab (FOLFOX-B) in patients with unresectable colorectal liver~          metastases, with the objective to downstage hepatic disease and enable complete~          resection of residual disease.~      Primary Objective:~        -  To evaluate the resection rate in patients with initially unresectable hepatic~          colorectal metastases downstaged with FOLFOX-B. Complete resection of all liver lesions~          is the goal.~      Secondary Objectives:~        -  To evaluate the probability of complete response, partial response or stable disease.~        -  To evaluate the proportion of patients who are resected, and the proportion of patients~          achieving an R0 resection (among those receiving surgery).~        -  To correlate survival with downstaging and resection based on metastatic colorectal~          prognostic score.~        -  To evaluate the disease-free survival and overall survival.~        -  To evaluate the positron emission tomography response rate.~        -  To explore correlations of clinical response with telomerase and hTERT expression.~   "
232810|NCT00508859|"~     This study examined the benefit of continued treatment with an antidepressant medication,~     sertraline, in adolescents with depression who improved on sertraline acutely. We hypothesize~     that adolescents who remained on sertraline long term were less likely to have a recurrence~     of depression compared to those on placebo.~   "
232811|NCT00508846|"~     Among women with HNPCC, this study will assess:~        1. Knowledge of screening recommendations for endometrial and ovarian cancers.~        2. Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers.~        3. Adherence to screening recommendations for endometrial, ovarian and colon cancers.~        4. Perceived benefits,supports and barriers to endometrial and ovarian cancer screening.~        5. Patterns of communication about endometrial and ovarian cancer risk within families with~          HNPCC and with health care providers.~        6. Patient preferences for potential cancer screening and cancer prevention strategies~          related to HNPCC-associated cancers.~   "
232812|NCT00508833|"~     This study was done to evaluate the effect of various adjuvants in combination with HBsAg as~     a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in~     healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the~     various adjuvanted vaccines.~   "
232813|NCT00508820|"~     This protocol will provide open label romiplostim to adult thrombocytopenic subjects.~     Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment~     will be based on platelet counts, and will be allowed throughout the duration of the study.~     Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP~     therapies may occur at any time when platelet counts are > 50,000.~   "
232814|NCT00508807|"~     Primary:~        -  To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase~          II dose of RTA 402 capsules in patients with advanced solid tumors or lymphoid~          malignancies who have failed standard-of-care curative or survival-prolonging therapy,~          or for whom no such therapies exist.~        -  To characterize the pharmacokinetics of RTA 402 capsules administered orally for 21 days~          in this patient population.~      Secondary:~        -  To document any preliminary antitumor activity of RTA 402 in this patient population.~        -  To determine the in vivo molecular and biological effects of RTA 402 by measuring~          changes in markers of differentiation, apoptosis, and anti-inflammatory effects in WBCs,~          blood plasma, and, in consenting patients, tumor biopsies.~        -  To correlate the biological activity of RTA 402 with drug concentration in plasma and~          blood cellular elements~        -  To evaluate the series of inflammation related symptoms over the course of the study,~          and to determine the correlation of symptom intensity with plasma cytokines.~   "
232815|NCT00508794|"~     In this study researchers will examine the initial efficacy of implementing a yoga program~     for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast~     cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG),~     or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and~     ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule.~     The sessions will be coordinated with the treatment schedule and conducted adjacent to the~     treatment facility. Measures will be obtained prior to randomization, a brief assessment~     during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3~     and 6 months after the last radiation session. With the inclusion of two control groups in~     this randomized trial researchers will attempt to validate the benefits of yoga as an~     adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for~     specific components of the yoga program and also examine some of the mechanisms that are~     necessary for the program to be effective.~      Our specific aims in the proposed study are to:~        -  Conduct an initial evaluation of whether participation in the yoga program improves~          patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with~          self-report measures and the use of actigraphy for a more objective measure of sleep~          quality.~        -  Secondary end points will include examining QOL, mental health and objective~          physiological outcomes (blood samples for immune measures, saliva samples for cortisol~          levels, and heart rate variability).~        -  Exploratory analyses will examine some plausible mediators of the yoga program including~          cognitive processing, spirituality, and finding meaning in the cancer experience.~   "
232816|NCT00508781|"~     We use multiphoton laser scanning microscopy to observe cutaneous anatomy and pathology. The~     study aims to compare surgical specimen by conventional pathology slice with the image by~     non-invasive multiphoton laser scanning microscopy.~   "
232817|NCT00508768|"~     The purpose of this study is to assess the pharmacokinetics of two oral dosing regimens of~     SCIO-469, with and without methotrexate, in patients with active rheumatoid arthritis.~   "
232818|NCT00508755|"~     Conventional therapies do not restore normal gait for many stroke survivors. The long-term~     goal of this work is to restore volitional lower limb motor control and gait following~     stroke. In our prior work, we demonstrated that it was feasible to provide a clinically~     operated, combined treatment of body weight supported treadmill training alone (BWSTT) +~     functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM).~      Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the~     feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke~     survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we~     propose to test the feasibility of the combination of Lokomat + FNS-IM.~      Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat +~     functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM).~      Treatment Procedures. The subjects will be treated for three months, four sessions/week (for~     a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into~     thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr~     Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the~     subject is capable of volitionally executing a given movement or gait component. Population.~     The subjects will be chronic stroke survivors (>6 months after the stroke).~   "
232821|NCT00508716|"~     The primary aim of this project is to test the efficacy of an inpatient congestive heart~     failure (CHF) educational intervention compared with usual care among inpatients at Griffin~     Hospital, who are largely drawn from the population of the Naugatuck Valley in Connecticut.~      The educational intervention will utilize:~        -  written educational materials suitable for patients with low health literacy -~          alternatives to written materials (e.g., video- and audiotapes) that may more~          effectively communicate health information to elderly patients and those with low health~          literacy~        -  a one-on-one educational session with a nurse patient educator. The educational session~          will use as its framework guidelines provided by the America Medical Association (AMA)~          to improve communication between healthcare providers and low health literacy patients.~          The investigators hypothesize that CHF patients who receive this educational~          intervention will have fewer hospital readmissions or deaths than the usual care group.~          The investigators further hypothesize that patients with low health literacy will derive~          more benefit from the intervention than patients with higher literacy.~      The secondary aims of the project are to:~        -  assess whether patients in the education and usual care groups differ on post-discharge~          CHF knowledge and on satisfaction with hospital care. Compared with usual care, the~          investigators hypothesize that CHF patients who receive the educational intervention~          will have better knowledge of CHF and will be more satisfied with the care they received~          in the hospital.~      The potential impact of the proposed project may be to increase disease knowledge and health~     literacy, and improve adherence to CHF treatments. This, in turn, may contribute to improved~     medical outcomes and reduced hospital readmissions for CHF patients. In addition, if this~     preliminary study provides evidence of a promising educational intervention suitable for~     patients with low health literacy, th investigators will endeavor to test the intervention in~     ethnically diverse populations throughout Connecticut.~   "
232822|NCT00508703|"~     The goal of this clinical research study is to use CT scans to find any changes in position~     of the vagina and pelvic lymph node areas during the course of IMRT radiation therapy.~     Treatment can then be adjusted in order to spare as much normal tissue as possible during~     radiation therapy. Another goal is to study the side effects of IMRT radiation therapy.~   "
232823|NCT00508690|"~     The purpose of this study is to determine optimal prophylactic antibiotics administration~     method in elective laparoscopic colorectal surgery.~   "
232824|NCT00508677|"~     This prospective pilot trial will evaluate the efficacy, safety, tolerability and~     pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.~   "
232825|NCT00508664|"~     The DeLOS II trial is a multicenter randomised phase II trial investigating a~     TP/5-Fluorouracil (TPF)-chemotherapy with or without cetuximab for Patients with only by~     laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in responder~     or non-responder after 4 weeks. Since August 2009 Responder receive TP with or without~     Cetuximab + radiation. (Until february 2009 Responder received TPF with or without Cetuximab~     + radiation.) Planned accrual is 85 patients per treatment arm. The primary study endpoint is~     a confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2~     years after randomisation.~   "
232826|NCT00508651|"~     The primary objective of this study is to describe the safety and tolerability of 3 doses of~     MEDI-560 at 10^5 TCID50 when administered to children 6 to < 12 months of age who are HPIV3~     (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to < 3 months of~     age regardless of baseline serostatus.~   "
232827|NCT00508638|"~     People with heart failure (HF) symptoms who are seen in the emergency department (ED) are~     often admitted to the hospital even though it may not be necessary. This study will gather~     information from HF patients seen in the ED to develop a decision-making tool that will help~     doctors predict the risk of HF-related death or serious complications. Improving the ability~     of ED doctors to effectively and safely manage low-risk HF patients should lead to fewer~     unnecessary hospitalizations.~   "
232828|NCT00508625|"~     This is a phase 2 multicenter, open label, randomized study of AMG 951 (rhApo2L/TRAIL) in~     subjects with previously untreated stage IIIb/IV NSCLC treated with chemotherapy with or~     without bevacizumab.~      Subjects will be assigned to a set of treatment groups depending on their eligibility to~     receive bevacizumab. Subjects with squamous NSCLC and/or CNS metastases will not be eligible~     to receive bevacizumab and will be assigned to either cohort A or B (provided all other~     eligibility criteria are met). Subjects who are eligible to receive bevacizumab will be~     assigned to cohort C, D or E. Cohorts are defined as follows:~      Subjects with squamous NSCLC or CNS mets:~      Cohort A: Chemotherapy alone Cohort B: Chemotherapy plus 8 mg/kg AMG 951 for 5 days~      Subjects without squamous NSCLC and without CNS mets:~      Cohort C: Chemotherapy and bevacizumab Cohort D: Chemotherapy, bevacizumab plus 8 mg/kg AMG~     951 for 5 days Cohort E: Chemotherapy, bevacizumab plus up to 20 mg/kg AMG 951 for 2 days~     Approximately forty subjects will be recruited to each cohort.~   "
232829|NCT00508612|"~     High blood pressure can often be caused by stress or anxiety. This study will evaluate a~     school-based stress and anger management program that aims to lower blood pressure and anger~     levels among high school students.~   "
232830|NCT00508599|"~     The hypothesis of this study is that bed rest in diabetic patients will result in a~     deterioration of metabolic control (primarily glucose).~      Specific aims:~        1. To determine the change in metabolic control in type 2 diabetic individuals when three~          days of bed rest is compared to three days of activity;~        2. To determine the rate of progression of the deterioration in metabolic control and the~          magnitude of the decrease;~        3. To assess whether the anticipated deterioration of metabolic control has effects on~          several parameters of glucose metabolism, including hyperglycemia and hypoglycemia;~        4. To determine the effects of bed rest on surrogate markers of atherosclerosis, such as~          plasminogen activator inhibitor 1 (PAI1), C-reactive protein (CRP), and homocysteine.~        5. To compare the effects of 48 hours of bed rest on orthostatic responses in type 2~          diabetic patients, and healthy non-diabetics.~        6. To make recommendations to the diabetic community to prevent metabolic deterioration~          during a 3 day hospitalization.~   "
232831|NCT00508586|"~     Formation of new blood vessels (angiogenesis) is important for tumor growth in metastatic~     breast cancer. It is known that tumors make a protein called vascular endothelial growth~     factor (VEGF) and there are higher levels of VEGF in the tumors and blood of many women with~     metastatic breast cancer. VEGF stimulates the formation of blood vessels that supply the~     tumor with nutrients and oxygen. PTC299 is an oral drug that has been shown to decrease~     production of VEGF in animal models of human cancer. In these animal models, oral PTC299~     administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood~     vessel numbers in the tumor, and significantly slows or halts tumor growth. Safety studies in~     research animals indicate good tolerability at doses and drug levels that are higher than~     those planned for the clinical studies. Results from Phase 1a studies in healthy volunteers~     indicate that PTC299 achieves levels of PTC299 in the bloodstream that are known to be active~     in animal models of human cancer. This Phase 1b study is designed to test the hypothesis that~     PTC299 will be tolerable and will show evidence of VEGF reduction and antitumor activity when~     administered orally in combination with anastrozole (Arimidex®), letrozole (Femara®), or~     exemestane (Aromasin®) to women with metastatic breast cancer.~   "
232837|NCT00508508|"~     Heart failure (HF) patients living in low-income or isolated areas may have limited access to~     necessary clinic services and more difficulty in self-managing their illness. This study will~     evaluate a program that combines group health care visits and a peer-to-peer telephone buddy~     system at improving health outcomes among low-income and racial minority HF patients.~   "
232838|NCT00508495|"~     The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability~     of two different paracetamol-containing solutions in postoperative total hip replacement.~     They will be compared to placebo (a dummy treatment which contains no active ingredient).~   "
232839|NCT00508482|"~     The purpose of this study is to re-evaluate the therapeutic superiority and safety of~     acupuncture treatment using high quality and large sampled clinical research. The~     investigators want to provide a preferred treatment protocol, which is effective, safe, and~     easy to use in clinical practice. This research also clarifies that the insertion depth is a~     key factor in the therapeutic effect of acupuncture. The results of the study will help~     promote the development of the standardization of acupuncture.~   "
232840|NCT00508469|"~     The purpose of the study is to compare adherence in patients on a fixed combination of~     travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004%~     and timolol 0.5% using the Travalert® device.~   "
232841|NCT00508456|"~     Objectives:~        1. To determine the safety, tolerability and efficacy of dietary methionine restriction for~          7 days alternating with Temodar® (Temozolomide) given once a day for seven days and this~          repeated for up to one year in the treatment of patients with recurrent and/or~          progressive glioblastoma.~        2. To determine the short- and long-term toxicity of dietary methionine restriction~          combined with Temodar® in glioblastoma patients.~        3. To measure and correlate patients' tumor responses and progression-free survival with:~          serum methionine and peripheral blood lymphocyte methylation levels. In any patient~          undergoing surgery, to measure tumor alkylguanyl transferase (AGT) and methionine levels~          and compare to control specimens.~   "
232842|NCT00508443|"~     The goal of this clinical research study is to find out if stereotactic spine radiotherapy is~     safe and effective in the treatment of metastatic spine tumors. The feasibility of this type~     of treatment will be studied as will any side effects related to the treatment. The precision~     and accuracy of the CT-on-rails will also be studied.~   "
232843|NCT00508430|"~     To demonstrate the superiority of ASP8825 over placebo and dose response in patients with~     painful diabetic polyneuropathy.~   "
232844|NCT00508417|"~     This study, conducted by the Malaria Research and Training Center at the Faculty of Medicine~     in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in~     Bancoumana, Mali. Information from the study will help in planning trials of malaria~     vaccines.~      Healthy children from 6 weeks to 6 months of age who live in the Bancoumana health area may~     be eligible for this study. Candidates are screened with a physical examination and blood~     tests.~      Participating children are visited at home for a total of about 17 visits to see if they are~     well. They come to the clinic every month during the 7-month study for a clinical evaluation,~     including a blood sample obtained by finger prick to test for malaria. Some of the blood~     collected may be stored and used for research. Children who become sick with malaria are~     treated for the disease.~   "
232845|NCT00508404|"~     To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective~     response rate and other measures of efficacy for patients treated with panitumumab in~     combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin~     (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).~   "
232846|NCT00508391|"~     The purpose of this study is to demonstrate that the safety and efficacy of the Lumax HF-T~     with optimized interventricular delay biventricular pacing (OPT) is non-inferior to the Lumax~     HF-T with simultaneous biventricular pacing (SIM) in patients with heart failure requiring~     cardiac resynchronization therapy.~   "
232847|NCT00508378|"~     Primary Objectives:~        1. To assess the preferences of women with ovarian cancer, their clinical caregivers,~          familial caregivers, and a control group for toxicities associated with chemotherapy.~             -  To compare preferences of women with ovarian cancer to preferences of their~               clinical caregivers.~             -  To compare preferences of women with ovarian cancer to preferences of their~               familial caregivers.~             -  To compare preferences of women with ovarian cancer to preferences of a women in~               the control group.~        2. To prospectively collect quality of life data from women with ovarian cancer.~        3. To prospectively collect symptom assessment data from women with ovarian cancer.~   "
232848|NCT00508365|"~     This is a multi-center, double-blind, randomized, placebo-controlled, 2-session crossover~     study to evaluate the incidence of orthostatic hypotension in elderly hypertensive subjects~     following co-administration of carvedilol CR and lisinopril.~   "
232849|NCT00508352|"~     Research has shown that treatment with conventional radiation techniques and chemotherapy~     following mastectomy or breast conserving surgery has resulted in better rates of~     locoregional control and overall survival in stage IIB-III breast cancer. The current~     feasibility trial using the most recent advance in radiation therapy, namely helical~     tomotherapy intensity modulated radiation therapy (HT-IMRT), hopes to improve on the results~     of conventional radiation by decreasing the amount of radiation-induced toxicity in patients~     with stage IIb-III breast cancer.~   "
232850|NCT00508339|"~     Primary Objectives:~        1. To classify the types of wound healing complications that occur after pre-operative~          radiation therapy and limb sparing resection for the treatment of soft tissue sarcomas~          of the extremity.~        2. To evaluate the impact of each complication type on patient function and quality of life~          using the Toronto Extremity Salvage Score (TESS).~   "
232851|NCT00508326|"~     The goal of this clinical research study is find the highest tolerated dose of paclitaxel~     that can be given directly into the liver of patients with advanced cancer involving the~     liver. Researchers also want to collect descriptive information on any effects the drug may~     have on tumor tissue.~   "
232927|NCT00507325|"~     The goal of this laboratory research study is to collect blood and tumor samples from~     patients with malignant melanoma. Researchers want to store these samples in a secure and~     confidential laboratory at M. D. Anderson. Researchers will use the information that is~     learned in this study to help find ways to improve treatment for melanoma and other cancers.~   "
232852|NCT00508313|"~     The goal of this clinical research study is to evaluate whether thermal imaging (recording~     body temperature) can be used to check the body's response to cancer therapy.~      Primary Objective:~        -  The primary objective of this study is to establish techniques and methodologies of~          quantifying thermal signatures and their changes for cancer patients undergoing~          chemoradiation therapy.~      Secondary Objective:~        -  The secondary objective is to evaluate correspondence between changes of thermal~          signature of a normal organ, e.g. lung or esophagus, versus the toxicity of that organ~          from chemoradiation therapy.~   "
232853|NCT00508300|"~     The purpose of this study is to determine whether a epidural analgesia versus patient~     controlled analgesia reduces the medical recovery in patients undergoing elective~     laparoscopic colon surgery.~   "
232854|NCT00508287|"~     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of~     single doses of BMS-686117~   "
232855|NCT00508274|"~     Local study in China and Hong Kong to evaluate safety and efficacy in lapatinib +~     capecitabine in women with HER positive advanced or metastatic breast cancer. Primary~     objective is response rate.~   "
232856|NCT00508261|"~     The purpose of this study is to demonstrate, in 12-23 months old subjects, the~     non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™,~     compared to each vaccine administered individually and to licensed meningococcal vaccine~     Meningitec™.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
232857|NCT00508248|"~     Unlike for ventricular arrhythmias, the role of n-3 PUFAs in atrial arrhythmias has not been~     fully investigated. A recently published epidemiological study reported that in elderly~     patients, consumption of fish was associated with a lower incidence of atrial fibrillation~     over the 12 years of follow-up. This observation may be an indirect effect due to the overall~     beneficial effort of fish consumption on reducing ischaemic heart disease, however this~     association persisted after adjustment for confounding characteristics. Clinical data~     regarding the direct impact of n-3 PUFAs on atrial arrhythmias such as atrial~     fibrillation/flutter (AF) is lacking. However, as both INa and ICa-L are also in atrial~     myocytes, similar anti-fibrillatory actions by n-3PUFAs would be expected in atrial~     fibrillation and we would like to investigate this further. The primary aim of this study is~     to investigate whether dietary supplements of n-3 PUFA concentrates (1g fish oil/day~     comprising eicosapentaenoic acid, EPA 46% and docosahexaenoic, DHA 38%)) helps maintain sinus~     rhythm after cardioversion to normal sinus rhythm in patients with persistent atrial~     fibrillation.~   "
232858|NCT00508235|"~     The aim of this study is to determine if children with a higher disease severity have lower~     quality friendships than children who are less severely affected and children who are~     unaffected. Researchers will test the hypothesis that the quality of friendships is inversely~     related to their disease severity.~      Specific Aims:~        1. To use the FQQ to determine if the quality of friendships in children with NF1 is lower~          than the quality of friendships in unaffected children.~        2. To use a disease severity scale and the FQQ to determine if children who are less~          severely affected have higher friendship qualities than children who are more severely~          affected.~   "
232859|NCT00508222|"~     The study has been designed to test the hypothesis that in patients co-infected with HIV and~     HCV who exhibit maximal virologic suppression on a double class antiretroviral (ARV) regimen,~     including two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and a Non-nucleoside~     Reverse Transcriptase Inhibitors (NNRTI) or a Protease Inhibitor (PI) (boosted or not with~     ritonavir), simplification of highly active antiretroviral therapy (HAART) to Kaletra®~     monotherapy will represent a viable strategy without any negative impact on the virologic~     control of HIV infection.~   "
232860|NCT00508209|"~     The prognosis after retreating with high-dose melphalan with stem cell support after first~     relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can~     increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of~     adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the~     time to a second relapse can be prolonged.~   "
232861|NCT00508196|"~     Pacing from the right ventricle (as is current practice in patients implanted with permanent~     pacemakers for bradycardia), has been associated with worse outcomes particularly in heart~     failure patients. Recent clinical trials suggest that chronic right ventricular pacing (VP)~     is associated with worsening heart failure, increased strokes and atrial fibrillation.~     Hemodynamically, right VP results in delayed activation and contraction of the LV which can~     give rise to functional mitral regurgitation, shortened diastolic filling time and thus~     reduced coronary filling, as well as abnormal arterial pulsatile flow. The mechanisms for the~     deleterious effects of right VP in heart failure patients have not been previously~     investigated. Our aim of this study is therefore to investigate the hemodynamic effects of~     right VP in stable heart failure patients in terms of exercise cardiac output (CO, an~     important measure of myocardial function and prognosis), as well as endothelial function~     which may be deranged as a result of abnormal arterial pulsatile flow.~   "
232862|NCT00508183|"~     The study will identify if there is a difference of quality of life after surgery between two~     techniques used in surgery. The two different techniques are either the Single Row Fixation~     or the Double Row Fixation.~   "
232863|NCT00508170|"~     Primary Objectives:~        1. To determine whether high-risk sexual behaviors are more common in patients with~          oropharyngeal cancer than in patients with head and neck cancers of other sub-sites.~        2. To determine if high-risk sexual behaviors are more common in patients with HPV (human~          papillomavirus) associated head and neck cancer than those without evidence of HPV-16~          infection.~   "
232864|NCT00508157|"~     258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or~     quetiapine in the treatment of schizophrenia and currently presenting with metabolic~     syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a~     range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical~     antipsychotic treatment prior to the study enrollment.~   "
232957|NCT00506935|"~     The purpose of this study is to find out if GVG can reduce drug use and determine safety and~     effects of GVG when used together with methamphetamine. This study involves staying in the~     hospital for 21 days. Participants will receive either placebo or GVG, and a limited amount~     if methamphetamine will be injected on some study days. This study will enroll people that~     use methamphetamine. Participants will be compensated.~   "
232865|NCT00508144|"~     The goal of this clinical research study is to learn how effective the drug pemetrexed~     (ALIMTA®) is in treating advanced NSCLC in patients with poor performance status (PS)~     (inability to perform every day activities without difficulty).~      Objectives:~      Primary Objectives:~        -  PS = 2 cohort: Response~        -  PS = 3 cohort: Descriptive~      Secondary Objectives:~        -  Tolerability of single agent pemetrexed (Alimta®) in PS = 3 NSCLC patients~        -  Improved symptoms (both cohorts)~        -  Molecular Correlative studies (both cohorts)~        -  Overall survival~        -  Time to progression~   "
232866|NCT00508131|"~     Iron deficiency and anemia in infants and young children impair neurodevelopment. Efficacious~     interventions for reducing the prevalences of iron deficiency and anemia, under controlled~     conditions, are available. However, little information is published about the effectiveness~     of large-scale programs.~      Objective. Assess the effectiveness on iron deficiency and anemia in young children of a~     large-scale program that provides iron fortified milk at a subsidized price to low income~     households. Design, Setting, and Sampling. A randomized effectiveness study in 12 milk~     distribution clusters randomly selected from 542 clusters in 4 States in Mexico. Selected~     clusters were randomly assigned to receive iron-fortified milk FM, N=7) or non-fortified milk~     (NFM, N=5). Over 95% program beneficiaries with children 12-30 mo of age in the 12 clusters~     (490 in FM and 275 in NFM) were enrolled in the FM and NFM interventions and participated in~     a baseline survey. 635 children (405 in FM and 230 in NFM) and 584 children (371 in FM and~     213 in NFM) completed the 6 and 12-mo follow-up surveys, respectively. Intervention: A daily~     portion of FM contained 5.28 mg of iron, 48 mg of sodium ascorbate and other added~     micronutrients. The FM and NFM were distributed to beneficiaries at a subsidized price in~     Milk Distribution Centers in the 12 clusters.~      Main outcome measures: Mild-to-moderate anemia (Hb: 90-109 g/L), mild anemia (Hb: 100-109~     g/L), moderate anemia (Hb: 90-99 g/L),iron deficiency: Serum Ferritin (SF) <12 ug/L and~     soluble transferring receptors (sTfR) >6 mg/L.Serum Zinc deficiency (< 65ug/dL), and stunting~     (<2SD Height/Age.~      Intervention effects at 6 and 12 moths were assessed using General Linear Mixed Models with~     three repeated measures.~   "
232867|NCT00508118|"~     Objective~      The objective of this study is to discover whether an infusion of nicardipine is able to~     reduce the time taken to achieve electrocerebral silence (ECS) during cardiopulmonary bypass~     (CPB) for aortic surgery.~      Hypothesis~      By inhibiting cold-induced cerebral vasoconstriction, nicardipine will maintain cerebral~     blood flow and allow more rapid cooling of the brain during CPB. This will manifest as a~     reduction in the time taken to achieve ECS and also as a reduction in overall CPB time.~   "
232868|NCT00508105|"~     This pilot study is being conducted to compare 2 methods of access to the shoulder for~     arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.~   "
232869|NCT00508092|"~     The purpose of this study is to assess whether the use of local anesthetic to numb the nerves~     that run deeper in the abdominal wall gives better post operative pain control than just~     infiltrating local anesthetic to the wound edges.~   "
232870|NCT00508079|"~     Peripheral venous disease occurs when a vein becomes damaged or blocked. It can occur almost~     anywhere in the body, but is most common in the arms and legs. This study will examine people~     who participated in a previous venous disease study to evaluate changes in leg veins and~     venous disease status over a period of 11 years.~   "
232871|NCT00508066|"~     The purpose of this study is to evaluate the effects of continuous local anesthetic delivery~     on the immediate post-op recovery of patients undergoing spinal fusion surgery for congenital~     or idiopathic scoliosis.~   "
232872|NCT00508053|"~     The purpose of this study is to determine whether a technique using very small stitches when~     closing a midline incision can reduce the risk for wound complications such as incisional~     hernia, infection or dehiscence.~   "
232873|NCT00508040|"~     Birdshot Retine choroidopathy (BRC) is a sight threatening posterior uveitis. The long term~     visual outcome has recently be studied showing a legal blindness to 14% at 5 years. Visual~     acuity is threatened by macular edema (80%), macular atrophy, and choroidal~     neovascularization.~   "
232874|NCT00508027|"~     Recent clinical and experimental data indicate that statins have effects beyond cholesterol~     lowering that may be beneficial in sickle cell disease by protecting the vascular~     endothelium. Statins have been shown to attenuate endothelial dysfunction through their~     anti-inflammatory, anti-oxidant and anti-thrombotic properties. This phase I/II~     dose-escalating trial is designed to assess the safety and potential clinical efficacy of~     oral simvastatin (Zocor)in adolescents and adults with sickle cell disease (SCD).~   "
232875|NCT00508014|"~     We will assess the impact of concurrent peer review vists on blood pressure, cholesterol and~     diabetes control. Concurrent peer review (CPR) visits refer to special offic visits by~     patients to a clinician (physician, nurse practitioner, or physician assistant) other than~     than their primary care provider that are specifically designed to improve care for diabetes~     and cardiovascular disease.~   "
232876|NCT00508001|"~     This is a multi-centre, phase II study to assess the efficacy and safety of ZD6474 in~     patients with Child-Pugh class A, inoperable HCC. This study comprises 2 phases, the primary~     treatment phase and the secondary treatment phase. The primary treatment phase is a~     randomised, double-blind, parallel-group phase II study to assess the efficacy and safety of~     ZD6474 300 mg plus best support care (BSC), ZD6474 100 mg plus BSC, and placebo plus BSC. The~     secondary treatment phase is an open-label expanded access program of ZD6474. In the primary~     treatment phase, patients will be randomised in a 1:1:1 ratio to receive ZD6474 300 mg plus~     BSC, ZD6474 100 mg plus BSC, or placebo plus BSC, respectively. Randomisation will be~     stratified on the basis of Cancer of the Liver Italian Programme (CLIP) tumour staging (CLIP~     score 0-2 versus 3-4). The primary treatment will continue until objective disease~     progression, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or~     until patients meet any other withdrawal or discontinuation criteria.The primary endpoint is~     tumour stabilisation rate, and the secondary endpoints are objective response rate,~     progression-free survival, and overall survival. The purpose of the secondary treatment phase~     is to expand the access of ZD6474 so that every patient who is enrolled into this study can~     have the chance to receive the active medicine.Once an individual patient has progressive~     disease in the primary treatment phase, the blind will be broken for this patient. If this~     patient is in the ZD6474 100 mg arm or placebo arm, the patient will be offered the secondary~     treatment with ZD6474 300 mg per day. If this patient is randomised to the ZD6474 300 mg arm,~     the study medication will be discontinued unless the patient wishes to remain the treatment,~     and the patient is to be followed up for survival.~   "
232877|NCT00507988|"~     The primary purpose of the study is to assess whether a planning and problem-solving training~     is more effective in improving work therapy performance in patients with schizophrenia than~     traditional training programs addressing basic cognitive functions.~   "
232972|NCT00506740|"~     the objective of this study is to determine if the use of The Harmonic™ (an ultrasonic~     surgical instrument) in abdominolipectomy (tummy tuck)reduces volume and duration of wound~     drainage after surgery when compared to electrocautery.~   "
232878|NCT00507975|"~     There are no established evidences as to the effectiveness in smoking pregnant women of~     nicotine patches in increasing birth weight, smoking abstinence during pregnancy and~     concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that~     the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation~     may be necessary in this population. The main aim of this study is to assess the~     effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth~     weight and maternal smoking abstinence. The main secondary objective is the assessment of~     safety of these treatments for the fetus/newborn and for the mother.~   "
232879|NCT00507962|"~     The goal of this clinical research study is find the highest safe dose of cisplatin that can~     be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver.~      PRIMARY Objectives:~      To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial~     hepatic (HAI) cisplatin with systemic intravenous liposomal doxorubicin in patients with~     cancer metastatic to the liver.~      SECONDARY Objectives:~      To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial~     cisplatin in combination with systemic liposomal doxorubicin.~   "
232880|NCT00507949|"~     The purpose of this trial is to study the effect of megestrol acetate in the gain of body~     weight in patients with severe Chronic obstructive pulmonary disease in order to improve the~     survival of the patients.~   "
232881|NCT00507936|"~     This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules)~     administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine~     60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study~     at approximately 50 sites in both the United States and Europe. The study will be divided~     into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an~     8-week Treatment Period and a 1-week Follow-up Visit.~   "
232882|NCT00507923|"~     The goal of this behavioral research study is to learn if participating in a Tibetan yoga~     program helps to improve quality of life for women during treatment for or recovery from~     breast cancer. Researchers are also interested in whether the yoga program helps to improve~     sleep, lung function, and physical therapy, based on outcomes.~   "
232883|NCT00507910|"~     In this study we are trying to determine the incidence of flat foot (also called pes planus)~     among patients who have had an ankle fracture. As compared to the general population, it is~     predicted that the incidence of pes planus will be higher among people who have fractured~     their ankle.~   "
232884|NCT00507897|"~     The purpose of this study is to determine the relationship of hemodynamic parameters with the~     level of thyroid hormones and the histological structure of thyroid nodules in euthyroid~     patients.~   "
232885|NCT00507884|"~     The goal of this clinical research study is to find out if 3 Tesla MRI is as good as CT~     scan in the evaluation of kidney tumor(s).~      Objectives:~      To provide preliminary data to enable subsequent development of an MRI protocol at 3 Tesla~     for evaluation of renal tumors and their vascular supply, which can be adopted in patients~     who are unable to undergo CT evaluation.~   "
232886|NCT00507871|"~     Cryptosporidium is an intestinal parasite that causes diarrhea in children and adults. In~     addition to infection of the stomach, this parasite can infect the respiratory system causing~     a cough and/or problems breathing. This study will enroll 480 children between the ages of 9~     and 36 months who come to Mulago Hospital for treatment of diarrhea. Researchers believe a~     large number of children with diarrhea and cough will have the parasite present in their~     sputum (mucus coughed up). Researchers also believe that children who have respiratory tract~     cryptosporidiosis may have a cough, increased number of breaths per minute, and/or a lower~     oxygen level. Blood, stool, saliva, and sputum samples will be collected from all children in~     the study and tested for Cryptosporidium. Children too young to provide a sputum sample will~     have a tube placed to collect a mucus sample from the lungs. Study participation may be as~     short as 4 hours or as long as 2 days depending on each child's health.~   "
232887|NCT00507858|"~     Primary Objective:~        -  To determine the maximum tolerated doses (MTDs) of pemetrexed when given with~          dexamethasone. (Please note: One of the three treatment groups will not receive~          dexamethasone)~      Secondary Objectives:~        -  To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia > 7 days~          duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4~          non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase~          toxicity.~        -  To determine objective response rate, as defined as complete response (CR) or partial~          response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with~          pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck.~   "
232888|NCT00507845|"~     Primary:~        -  To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients~      Secondary:~        -  To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.~   "
232889|NCT00507832|"~     The development of the topical calcineurin inhibitor pimecrolimus resulted in a significant~     improvement in the treatment of atopic dermatitis. In addition, an excellent amelioration of~     pruritus could be regularly observed. Up to now, several itchy dermatoses such as chronic~     irritative hand dermatitis, rosacea, graft-versus-host-disease, lichen sclerosus, prurigo~     simplex, scrotal eczema, and inverse psoriasis were reported as single cases also to respond~     to a pimecrolimus treatment.~      In prurigo nodularis, pruritus is the main symptom and it is of immediate importance to find~     an effective antipruritic therapy. Pruritus is regularly severe and therapy refractory to~     topical steroids or systemic antihistamines. Capsaicin cream is one effective possibility to~     reduce the itch in these diseases. However, it has to be applied 3 to 6 times daily, rubs off~     on the clothing and induces burning in erosions. In addition, since no commercial preparation~     is available, it has to be prescribed in several concentrations. The application of~     pimecrolimus seems to be promising since it has to be applied twice daily only. Especially in~     prurigo nodularis we expect a good response as we could demonstrate in single patients.~     Furthermore it has been published recently that Tacrolimus, another calcineurin inhibitor has~     been successfully used in the treatment of six patients with prurigo nodularis.~      This study is designed to compare the efficacy and safety of pimecrolimus 1% cream and~     hydrocortisone 1% cream in prurigo nodularis and to investigate the mode of action of the~     antipruritic effect of the drugs.~   "
232890|NCT00507819|"~     In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance~     in patients with a single cardiac ventricle who have undergone the Fontan operation. The~     investigators will also evaluate echocardiographic measures of ventricular function and~     measure quality of life changes using two validated quality of life measures. The hypothesis~     is that sildenafil will result in increased exercise tolerance in patients who have had the~     Fontan operation as compared to placebo.~   "
232891|NCT00507806|"~     The study is designed to examine the safety, tolerability, and activity of a combination of~     microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz~     transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen~     activator (tPA) treatment in subjects with acute ischemic stroke.~   "
232892|NCT00507793|"~     To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly~     with a fixed dose of sirolimus in kidney transplant recipients.~   "
232893|NCT00507780|"~     This study will examine whether the drug cetrorelex acetate (Cetrotide[Registed Trademark])~     can protect ovarian function in women undergoing chemotherapy. Some cancer treatments are~     known to cause a change in women's periods or to cause menstruation to stop completely, so~     that they cannot become pregnant. Cetrorelex acetate has been used for many years to lower~     hormone levels and stop periods in patients undergoing in vitro fertilization treatments.~     This study will see if making the ovaries inactive may protect them from being affected by~     certain cancer drugs, and thus preserve fertility.~      Women up to age 21who have begun menstruating, who have their uterus and at least one~     functioning ovary, and who are undergoing chemotherapy with cyclophosphamide, busulfan,~     nitrogen mustard or L-phenalanin mustard may be eligible for this study.~      Participants undergo the following procedures during this 24-month study:~      Baseline evaluation~        -  Medical history, physical examination and blood and urine tests~        -  Questionnaire about quality of life, menstrual periods, vaginal bleeding and desire for~          future fertility~        -  3D ultrasound of abdomen~        -  DEXA scan to evaluate bone density~      Assignment to treatment with:~        -  Lo ovral (contraceptive pill to prevent pregnancy and control menstrual periods) alone,~          or~        -  Lo ovral and the study drug cetrorelex acetate, given as an injection under the skin~          once a day for six menstrual cycles~      Evaluations~        -  Transvaginal 3D ultrasound to monitor changes in the ovary - after 6 months of~          cetrorelex acetate injections~        -  DEXA scan - after 6 months of cetrorelex acetate injections~        -  Blood tests for safety monitoring, pregnancy testing, endocrine tests and research uses~          - every 3 months during first year, every 6 months during second year~        -  Questionnaire to monitor changes and quality of life - every 3 months during first year,~          every 6 months during second year.~   "
232894|NCT00507767|"~     This phase II trial studies how well dasatinib works in treating patients with head and neck~     cancer that has come back or spread to other areas of the body. Dasatinib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
232895|NCT00507754|"~     Primary Objective:~      1. To evaluate the performance of the new T-SPOT.TB test and the conventional TST for~     screening of Latent Tuberculosis infections in patients with cancer and those undergoing~     Hematopoietic Stem Cell Transplant.~      Secondary Objectives:~        1. To examine the factors associated with positive response to T-SPOT.TB and the TST~          (tuberculin skin test) in patients with anergy.~        2. To determine the impact of immunosuppressive and antineoplastic therapy on the screening~          performance of T-SPOT.TB and the TST in cancer patients.~   "
232896|NCT00507741|"~     This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in~     participants with advanced ovarian and endometrial cancers.~   "
232897|NCT00507728|"~     The goal of this behavioral research study is to learn more about how the drugs Bupropion and~     Varenicline affect mood and physiological responses in different groups of people as they~     attempt to quit smoking. Researchers want to learn how these drugs affect responses related~     to changes in emotion and whether or not a person's genetic make-up makes a difference in how~     they respond to the medication.~   "
232898|NCT00507715|"~     The purpose of this trial is to study the effect of the association levodopa/carbidopa with~     plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being~     treated with levodopa/carbidopa.~   "
232899|NCT00507702|"~     To identify unique blood markers in cancer patients so that we can identify patients with~     evidence of pre-existing immunity who may be a responder to immunotherapy.~   "
232900|NCT00507689|"~     The objective of this 96-week study was to evaluate the safety and antiviral efficacy of~     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without~     hepatitis B immunoglobulin (HBIg) in preventing the recurrence of chronic hepatitis B~     following liver transplantation, in participants who were chronically infected with hepatitis~     B prior to transplantation.~      Prior to enrollment, participants were required to have received at least 12 weeks of HBIg~     therapy following liver transplantation. Enrolled participants then received FTC/TDF plus~     HBIg for an initial 24-week pre-randomization treatment period. Participants who completed~     the pre-randomization period and who achieved sustained viral suppression were randomized to~     continue treatment with FTC/TDF with or without HBIg for an additional 72 weeks (randomized~     period). The antiviral efficacy of treatment was assessed by measuring hepatitis B virus~     levels in the blood (HBV DNA). Safety and tolerability was monitored by assessing adverse~     events and various laboratory parameters.~   "
232901|NCT00507676|"~     Infants will be enrolled into this study in one of three groups. First, there will be a group~     of full term infants with no history of wheezing. Second, there will be a group of infants~     receiving a ct scan that is non-respiratory related. Third, there will be a group of infants~     that are born full term but have a history of wheezing of at least 3 episodes. The three~     groups will be compared to see if there is a difference in lung function, lung structure and~     lung size. Besides comparing the testing results we will be evaluating environmental and~     inherited characteristics. There are 2 purposes of this study. The first purpose is: To~     determine whether asymptomatic groups of infants at high risk for wheezing (Environmental~     tobacco smoke (ETS) exposure, Fm Asthma, male Gender) have fixed or reversible airway~     narrowing. The second purpose of this study is: To determine the relative contributions of~     fixed and reversible airway narrowing in infants with recurrent symptomatic wheezing, and to~     determine whether fixed and reversible airway narrowing is related to ETS exposure, Fm~     Asthma, and male Gender.~   "
232937|NCT00507195|"~     The study proposes to analyze the difference in the rapidity of the recovery of post~     operative cognition immediately after extubation and 20, 40 and 60 minutes post extubation~     and neuropsychological complications (delirium) after 48 hours following general anesthesia~     using a prospective, randomized approach. Patients undergoing any type of surgery with the~     exception of cranial, cardiac or thoracic surgery can be enrolled in the study.~   "
232938|NCT00507182|"~     The goal of this clinical research study is to test a new way to look for cancer and~     pre-cancerous tissue changes inside the mouth.~   "
232902|NCT00507663|"~     This study proposes a prospective randomized study of elders undergoing elective major~     abdominal surgery to assess recovery following a unique anesthetic regimen incorporating a~     adrenergic receptor antagonist. The purposes of this study are to:~        1. to determine if using atenolol, a beta-blocker drug commonly used to treat high blood~          pressure and heart disease, as part of your anesthetic regimen will decrease~          complications that sometimes occur in elderly patients who are undergoing surgery and~          being given anesthesia.~        2. to see if it improves or quickens your recovery from anesthesia and surgery.~        3. to help investigators design better ways to administer anesthesia during surgery,~          especially in elderly patients, so that the complications and the time to recover from~          surgery and anesthesia can be decreased.~   "
232903|NCT00507650|"~     The purpose of this study is to determine whether providing extra fluid to nursing home~     residents will help prevent or heal pressure ulcers. We hypothesize that providing extra~     fluid to nursing home residents will increase their skin blood flow and oxygen to support~     healing and maintaining healthy skin. Participants are enrolled who have a pressure ulcer or~     who are at-risk for an ulcer (determined by looking at risk factors). The study is divided~     into two 10 day phases. In Phase 1, we examine participant's usual status, including fluid~     intake and baseline healing potential. In Phase 2, participants are randomly placed in groups~     to receive either their usually prescribed fluid intake or additional fluid. A study nurse~     provides the fluid to the residents. We measure their actual intake, their body water, how~     well their kidneys are working, their potential to heal, and also monitor them for the~     development of fluid overload. This study is important because it helps us understand the~     role of a basic nursing intervention in the prevention and treatment of pressure ulcers.~   "
232904|NCT00507637|"~     The objective of this Phase II study is to show that pre-treated patients with BEB with the~     need of shortened injection intervals achieve an improved and stable quality of life level if~     they receive repeated NT 201 injections at short injection intervals. In addition, the~     tolerability of repeated shortened NT 201 administrations in patients with BEB including the~     development of neutralizing antibodies will be investigated.~   "
232905|NCT00507611|"~     The purpose of the present proposed clinical trial will be to assess the utility of SLN~     mapping and biopsy for predicting the final axillary status after completion of preoperative~     neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph~     nodes at initial presentation~   "
232906|NCT00507598|"~     The purpose of this study is to collect specimens to perform metabolic profiling of serum and~     urine from patients with colorectal cancer, colon polyps and healthy patients.~   "
232907|NCT00507585|"~     PRIMARY:~        -  To determine the toxicity and tolerability of intra-arterial hepatic oxaliplatin every~          three weeks administered in combination with systemic intravenous Fluorouracil,~          Leucovorin and bevacizumab to patients with advanced solid tumors metastatic to the~          liver.~      SECONDARY:~        -  To document in a descriptive fashion the antitumor efficacy of this combination regimen.~        -  To evaluate the feasibility and accuracy of an alternate radiographic assessment tool~          and compare with available tumor markers and RECIST guidelines.~        -  To estimate in a descriptive fashion the development of extrahepatic tumor recurrences.~   "
232908|NCT00507572|"~     You are being asked to take part in this study because you are pregnant or have been pregnant~     while diagnosed with cancer.~      The goal of this research study is to collect information on patients who are or were~     pregnant while diagnosed with cancer and to store this information in a research database.~      This is an investigational study. About 500 patients will take part in this study. All will~     be enrolled at MD Anderson.~   "
232909|NCT00507559|"~     A prospective, non-randomized, multi-center clinical study to evaluate the safety and~     effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair~     historical control group in the treatment of abdominal aortic aneurysms (AAA).~   "
232910|NCT00507546|"~     The purpose of this study is to determine if replacing melatonin function with a melatonin~     agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia)~     helps to alleviate self-reported sleep disruption.~   "
232911|NCT00507533|"~     The purpose of this study is to evaluate the use of CPAP in the prevention of acute~     respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied~     preventively in hematological patients with high risk of ARF may reduce:need for intubations~     and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of ICU and~     hospital stay~   "
232912|NCT00507520|"~     To assess the effects of almonds on coronary heart disease (CHD) risk factors (serum lipids,~     measurements of oxidative stress and nitric oxide production) when added to the diets of~     subjects with high cholesterol. Also, to assess whether the amount of almonds consumed (i.e.~     almond dose) decreases CHD risk factors in a dose dependent manner. We hypothesize that since~     almonds have been shown to reduce serum lipids, we believe they will also increase nitric~     oxide levels related to their high levels of arginine and reduce markers of oxidative stress~     related to their content of bioactive phenolics. We anticipate that a dose-dependent~     relationship will be observed resulting in greater reductions in risk factors for coronary~     heart disease when greater doses of almonds are consumed.~   "
232925|NCT00507351|"~     The primary purpose of this study is to examine the feasibility of collecting pain and other~     symptom data in outpatient treatment centers across multiple institutions in the Texas~     Medical Center (TMC). We will also examine the prevalence and severity of cancer-related pain~     and begin to identify other commonly reported symptoms in outpatient settings. Factors that~     interfere with management of pain will also be examined. Additionally, the study will explore~     patient satisfaction with pain management and pain education in outpatient settings. The~     specific aims of this study include:~      Primary Objective:~      -Explore the feasibility of a collaborative effort by oncology nurses to collect pain and~     symptom data across multiple institutions that care for ambulatory cancer patients in the~     TMC.~      Secondary Objectives:~        -  Describe the prevalence and severity of pain and other symptoms in persons with breast,~          colorectal, lung, or prostate cancer who are receiving chemotherapy in the outpatient~          setting.~        -  Describe factors that interfere with adequate pain management in these patients.~        -  Examine patient satisfaction with pain management and patient education about pain~          management.~   "
232926|NCT00507338|"~     ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their~     primary treatment for heart attack.~   "
232913|NCT00507507|"~     The main objective of the study was to evaluate the antiviral activity of tenofovir~     disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF~     combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the~     immune tolerant phase of HBV infection.~      The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was~     evaluated for suppression of the virus (decrease in HBV DNA), serological response~     (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and~     the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF~     monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events~     and changes in laboratory parameters.~      Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus~     tenofovir DF. All subjects were to continue on blinded study medication until the last~     subject reached Week 192. Participants who permanently discontinued study drug (on or before~     Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of~     alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or~     after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to~     antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their~     regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject~     reached Week 192.~   "
232914|NCT00507494|"~     The purpose of this study is to test whether pioglitazone is able to prevent the progression~     of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.~   "
232915|NCT00507481|"~     The aim of this study was to investigate the relationship between sleep disturbances and~     delirium in surgical ICU patients. The study set up to test the hypothesis that the~     occurrence of delirium is associated to the alteration of sleep quality and quantity observed~     in the critically ill patients.~   "
232916|NCT00507468|"~     The object of this open-labeled, uncontrolled pilot study was to investigate the safety and~     feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the~     myocardium using the helical needle transendocardial (TE) delivery system in stable coronary~     patients with ventricular dysfunction due to chronic myocardial infarction (MI).~      A secondary goal was to assess the possibility that such cell injections could improve~     ejection fraction (EF).~   "
232917|NCT00507455|"~     A study to evaluate the safety of the co-administration of solifenacin succinate with~     tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet~     obstruction (BOO).~   "
232918|NCT00507442|"~     The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with~     VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone,~     cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no~     prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and~     Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR)~     rate.~   "
232919|NCT00507429|"~     The purpose of the study is to determine the safety and efficacy of combretastatin combined~     with paclitaxel and carboplatin in the treatment of anaplastic thyroid cancer (ATC).~   "
232920|NCT00507416|"~     This is a randomized, open label, multicenter clinical trial to compare the efficacy and~     safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and~     dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated~     multiple myeloma not considered candidates for high-dose chemotherapy and autologous stem~     cell transplantation.~   "
232921|NCT00507403|"~     There is a great individual variability of pharmacokinetic of infliximab in patients treated~     for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate~     (MTX), others have not.~      Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties~     of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.~   "
232922|NCT00507390|"~     This is a hypothesis testing study, the hypothesis being that dietary supplements of n-PUFAs~     concentrates are anti-arrhythmic in ventricular arrhythmic substrates.~      Study Aims: To investigate whether dietary supplements of n-3 polyunsaturated fatty acid~     concentrates (2g PUFAs/day, Omacor) reduces MTWA (a surrogate endpoint for ventricular~     arrhythmia substrate) in patients with ICDs for malignant ventricular arrhythmias.~   "
232923|NCT00507377|"~     Background The existence, diagnosis and treatment of short esophagus is one of the~     controversies of the past which has recently re-emerged The missed diagnosis of short~     esophagus and the consequent inadequacy of treatment is one of the major causes of failure of~     antireflux surgery.~      The daily clinical practice of surgeons dedicated to therapy of esophageal diseases could~     take advantage of the definition of frequency, preoperative predictors, intraoperative~     management and post operative outcomes of cases of foreshortened esophagus, in order to offer~     the patient affected by GERD the elements necessary for a conscious choice of therapy and to~     plan the best performance of the surgical procedure.~      Aims of the Study To define the percentage of cases among the total of antireflux procedures~     performed, in which, after standard isolation of the ge junction and eventual dissection of~     the mediastinal esophagus at least two centimetres of esophagus can not be replaced without~     any applied tension below the apex of the diaphragmatic hiatus.~      To define the percentage of surgical procedures aimed to treat electively a condition of non~     reducible G-E junction and foreshortened esophagus, among a multicentric formed case series~     of patients submitted to antireflux surgery.~      To define the preoperative clinical and instrumental predictors for a surgical procedure~     aimed to treat foreshortened esophagus.~      To record the intra-operative, postoperative, 6 month and 12 month outcome of procedures~     adopted for the surgical treatment of GERD.~      Materials and Methods The study will comprise patients in which surgical therapy for GERD is~     indicated according to the international guidelines and the Centres policy .~      Patients will be submitted to the antireflux procedure chosen by the surgeon according to the~     internationally recognized scientific surgical principles and the personal judgement.~      The preoperative study and the postoperative follow up adopted in the present study are~     accepted by the Centres as they correspond to the international guidelines and the Centres'~     current practice criteria for the surgical treatment of GERD.~   "
232924|NCT00507364|"~     Chronic anal fissure is a linear tear in the distal anal canal. Most chronic fissures require~     intervention to heal. Surgical sphincterotomy is currently performed. However, the procedure~     permanently weakens the internal sphincter and may be associated with permanent complications~     such as incontinence. Current topical treatment or  chemical sphincterotomy is effective in~     the short term for about 70% of the patient more than 50% of them will suffer from~     recurrence. Number of studies support the hypothesis that local ischemia is the reason for~     failure to heal in anal fissure. Treatment of refractory wounds by macrophage suspension is~     an innovative method since 1995, macrophage suspensions have been used successfully in more~     than 1400 patients in several hospitals in Israel without any side effect.Macrophages have~     key function in almost every stage of wound healing. They help in the digestion of bacteria,~     in a later stage, they secret IL-6, which influences endothelial cell proliferation and the~     initiation of angiogenesis.~      The study hypothesis is that local injection of activated human macrophages into chronic anal~     fissure may induce fissure healing.~   "
232928|NCT00507312|"~     This study will be testing two devices which are designed to detect cardiovascular disease in~     patients as early as possible. As there are now many therapies to prevent and treat this~     condition it is believed that detecting it early will help reduce the burden of the disease~     and permit more effective treatment.~      The two devices the investigators are testing are the ViScope developed by HD Medical and a~     device developed by CSIRO. Both of these devices are simple, non-invasive and may provide~     useful information on how well the heart contracts and relaxes as well as valve function of~     the heart.~      The investigators are planning to enroll 100 healthy subjects, 100 participants with risk~     factors for heart failure and 300 patients with varying types of heart failure.~      The data collected from the experimental devices will be compared to the results from~     standard tests.~      Patients will not have any of their therapies altered as part of this study.~   "
232929|NCT00507299|"~     This study aims to enhance pediatric primary care to make it more responsive to psychosocial~     needs facing many families. We hypothesized that by identifying and addressing certain~     problems, such as depressed mothers, parental drug use, and domestic violence, we would help~     decrease child abuse and neglect.~   "
232930|NCT00507286|"~     Erectile dysfunction (ED or impotence) is a common medical condition affecting many men world~     wide. The most commonly used treatment for ED are oral medications like Viagra (sildenafil),~     Levitra (vardenafil) and Cialis (tadalafil). If these are not effective the use of an~     injection into the penis (intracavernosal injection or ICI) is necessary. However in some men~     neither of these therapies is successful.~      Hypothesis: An adequate erection may be achieved in men with difficult-to-treat erectile~     dysfunction, when they are treated with a therapy of combination of tablet and penile~     injection, when a single treatment therapy has failed for these men.~      Aim of the study is to test the safety and efficacy of a combination of Viagra and Caverjet~     Impulse in a group of men who had failed to achieve an adequate response to the maximum~     recommended dose of either Viagra, Cialis or Levitra and Caverjet Impulse, when these~     treatments were used alone.~      20 men with difficult to treat ED will be given oral medication, intracavernosal therapy or~     the combination in a single-blind randomised study.~      Informed consent will be signed prior to any study procedures being carried out. All~     participants are 'blinded' to their study treatments. Participants who have satisfactory~     response to any of the tablets or penile injections, will be excluded from the study.~   "
232931|NCT00507273|"~     The goal of this observational research study is to establish a registry of information~     regarding how different physicians treat and manage patients with gastrointestinal stromal~     tumors (GISTs).~      Objectives:~        1. To describe variation in management of patients with GIST, overall and by patient and~          provider characteristics.~        2. To provide participating physicians with information regarding management of their~          patients with GIST compared to the aggregate experience of all physicians participating~          in the Registry.~   "
232932|NCT00507260|"~     Primary Objective:~      1. To use the results from this pilot study to estimate the effect size of the nutritional~     intervention on fatigue and caloric intake.~      Secondary Objectives:~        1. To apply nutritional assessment tools for early detection of patients at risk for~          malnutrition.~        2. To examine the feasibility of conducting this intervention study.~        3. To describe cancer-related fatigue patterns among BMT patients at multiple time points~          during ambulatory visits.~        4. To evaluate the effects of a nutritional intervention for post-allogeneic BMT recipients~          on adequacy of caloric intake in order to improve cancer-related fatigue scores.~   "
232933|NCT00507247|"~     Primary Objective:~      Evaluate the efficacy and safety of daptomycin given for treatment of catheter-related~     bloodstream infections due to S. aureus bacteria with or without exchange of the central~     venous catheter (CVC) over guide wire in comparison with a historical control group of~     catheter-related S. aureus bacteremia treated with standard therapy (Vancomycin) or other~     active agents against staph aureus (such as beta-lactam antibiotics).~   "
232934|NCT00507234|"~     This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled,~     parallel-group, comparative study.~      The objectives of this study are:~        1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate~          Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.~        2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice~          daily compared to tiotropium 18 mcg once daily.~   "
232935|NCT00507221|"~     Abstract:~      Over 25 million HIV-1 infected individuals are currently living in Africa and as many as~     50-90% may be co-infected with soil transmitted helminths such as roundworms, hookworms or~     whipworms. Helminth infection in HIV-1-infected individuals may increase HIV-1 RNA levels and~     increase the rate of progression of HIV-1 to AIDS. Studies have also shown that successful~     treatment of helminth co-infection (as documented by clearance of helminth eggs in stool) led~     to a significant decrease in HIV-1 plasma viral load (-0.36 log10). This change in viral load~     was significantly greater than that seen in those individuals without documented clearance of~     their helminth co-infection (+0.67 log10) (p=0.04). Studies conducted in Africa have shown an~     estimated 2.5-fold increased risk for sexual transmission of the HIV-1 for each log increase~     in plasma HIV-1 viral load. In addition to direct effects on plasma viral load, the rate of~     CD4 cell decline in helminth infected individuals may be directly impacted by the significant~     immune activation seen with such co-infection.~      The investigators propose a randomized controlled trial examining the potential benefits of~     routine empiric helminth eradication in HIV-1 infected adults who do not yet qualify for~     antiretroviral (ARV) therapy in Kenya. The current standard of care of symptomatic diagnosis~     and treatment will be compared to a systematic empiric scheduled de-worming program for HIV~     infected adults. The investigators will compare markers of disease progression including rate~     of CD4 decline and changes in HIV-1 RNA levels between the two treatment arms.~   "
232936|NCT00507208|"~     The purpose of this study is to compare the use of the Dynasplint Trismus System to routine~     trismus treatment in improving the ability of opening the mouth in a randomized trial. This~     study will also determine what effects, good and/or bad, this procedure has on the~     participant. Participants will be randomly assigned to the Dynasplint Trismus System or to~     routine treatment with tongue depressors.~   "
232939|NCT00507169|"~     The study will examine which dose of SVT-40776 is best in terms of efficacy, safety and~     tolerability compared to placebo and tolterodine~   "
232940|NCT00507156|"~     Standard treatment of patients with acute ST-segment elevation myocardial infarction consist~     of acute re-opening of the occluded coronary artery (primary PCI). Despite successful~     treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final~     infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies~     have indicated that graded re-opening of the artery may limit tissue damage. Generally this~     is referred to as mechanical postconditioning.~      The study investigates the effect on final infarct size evaluated by magnetic resonance scan~     of postconditioning of ST-segment elevation myocardial infarctions. Mechanical~     postconditioning is performed by means of several balloon inflations in the injured vessel~     following its acute re-opening.~   "
232941|NCT00507143|"~     From 100 colorectal cancer patients being treated with FOLFIRI regimen or any kind of~     irinotecan containing regimen, blood samples for irinotecan and its metabolites levels and~     genotypes related with its metabolism will be collected. The association of their levels and~     genotypes and treatment effects will be evaluated.~   "
232942|NCT00507130|"~     The primary objective of this study is to evaluate the safety and tolerability of escalating~     multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.~   "
232943|NCT00507117|"~     Patients often have difficulty sleeping during overnight sleep testing in a lab environment.~     The purpose of this study is to determine if taking a sleep aid will improve sleep and~     therefore the quality of the sleep study.~   "
232944|NCT00507104|"~     This study performs assessments of pituitary functions by basal hormone levels in the acute~     phase after TBI and/or SAH followed by detailed endocrine tests (insulin-induced hypoglycemia~     or growth hormone releasing hormone-arginine-corticotropin releasing hormone-leuteinizing~     hormone releasing hormone [GHRH-arginine-CRH-LHRH] test) after 4 and 12 months.~   "
232945|NCT00507091|"~     A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with~     Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in~     patients with metastatic colorectal adenocarcinoma.~   "
232946|NCT00507078|"~     Recent years have witnessed major advances in the understanding of the hormonal, metabolic,~     and biochemical changes that occur in obstructive sleep apnea (OSA). This project evaluates~     the biomarkers that measure the most significant health impacts of this disorder and creates~     a specimen bank that will facilitate evaluations of additional biomarkers in the future.~   "
232947|NCT00507065|"~     Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of~     adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on~     weight (<= 75 kg or > 75 kg).~   "
232948|NCT00507052|"~     In our opinion, it is worth to check an ability of antioxidant therapy to produce a favorable~     effect on Residual Renal Function.~      The aim of our study is to investigate the effect of N-acetylsysteine on RRF in prevalent HD~     patients.~   "
232949|NCT00507039|"~     The study is meant to establish a one-step challenge with grass-pollen in patients sensitized~     for grass-pollen. Therefore the investigators compare a multi-step challenge with~     grass-pollen with an one-step challenge in order to survey the repeatability and safety.~   "
232950|NCT00507026|"~     This study will compare repeated intermittent IV dosing of diclofenac in patient with~     moderate to severe post-surgical pain from elective orthopedic surgery.~   "
232951|NCT00507013|"~     The QuickClose study is a prospective, non-randomized study, to evaluate the safety and~     efficacy of the QuickClose device using two different dose types of heat exposure.~      Patients undergoing a diagnostic angiogram procedure will be treated with the QuickClose~     device. Two groups of 20 patients each, will be enrolled consecutively, Group A will complete~     enrollment before enrollment into Group B begins. Patients will be monitored until 30 days~     after the procedure~   "
232952|NCT00507000|"~     Tuberculosis and vitamin D deficiency are important public health problems in India. Before~     the advent of effective antitubercular therapy, patients with tuberculosis were advised~     treatment and rest at sanatorium where sunshine was available in plenty. There have been~     reports associating vitamin D deficiency with tuberculosis in terms of incidence and~     beneficial response following addition of vitamin D to antitubercular therapy. Sputum AFB~     conversion rate is higher in patients with tuberculosis supplemented with vitamin D. The~     present study would systematically assess role of adjunct vitamin D therapy (cholecalciferol)~     in patients with pulmonary tuberculosis.~   "
232953|NCT00506987|"~     This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH~     486757 in subjects with chronic cough. Subjects will be randomized to receive SCH 486757 or~     placebo for 14 days. After a 2-week washout period, subjects will be crossed over to the~     other treatment. The primary objective is to evaluate the effectiveness of SCH 486757 in~     reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that~     induces cough.~   "
232954|NCT00506974|"~     The purpose of this study is to determine if there the impact of sleep deprivation upon~     sleepiness, attention, memory, and mood is reduced by pharmacologically enhancing slow wave~     sleep (SWS) with sodium oxybate.~   "
232955|NCT00506961|"~     This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration~     study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with~     type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with~     simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is~     superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and~     non-HDL-C (<130 mg/dL).~   "
232956|NCT00506948|"~     The goal of this clinical research study is to learn if the combination of rabbit~     anti-thymocyte globulin (Thymoglobulin®), sirolimus (Rapamune®), and mycophenolate mofetil~     (Cellcept®) can help to prevent graft versus host disease (GVHD). The safety of this drug~     combination will also be studied.~      Primary Objective: To determine efficacy and toxicity of a regimen of thymoglobulin,~     sirolimus and mycophenolate mofetil for prevention of acute GVHD after allogeneic stem cell~     transplantation from human leukocyte antigen (HLA) identical related or unrelated donors.~      Secondary Objective: To assess engraftment, chronic GVHD, relapse and survival.~   "
232973|NCT00506727|"~     Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions~     utilizing the SKAMP deportment scale.~   "
232974|NCT00506714|"~     The purpose of this study is to determine whether or not the use of a nonpharmacologic~     intervention (single point cane) is effective in the treatment of knee osteoarthritis.~   "
232958|NCT00506922|"~     Primary Objective:~      1. To determine efficacy of escalating doses of pentostatin in combination with tacrolimus~     and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in the context~     of unrelated donor and one antigen mismatched related donor transplantation.~      Secondary Objectives:~        1. To determine safety of escalating doses of pentostatin in combination with tacrolimus~          and methotrexate.~        2. To reduce the incidence of acute GVHD following transplants with unrelated donor to 40%.~        3. To document blood levels of tacrolimus when combined with pentostatin.~   "
232959|NCT00506909|"~     The objective of the study is to compare the efficacy of intranasal oxytocin versus~     intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms~     despite being on adequate treatment with antipsychotic medication.~   "
232960|NCT00506896|"~     The purpose of this study is to compare the efficacy and safety of intra-articular~     glucocorticoid injection to its systemic use for treatment of knee synovitis in patients with~     Rheumatoid Arthritis~   "
232961|NCT00506883|"~     This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group,~     dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8~     mg) versus low-dose colchicine (1.8 mg) or placebo for acute gout flares.~   "
232962|NCT00506870|"~     To evaluate the benefit economic and medical of self-monitoring of coagulation compared with~     conventional follow-up of anticoagulation in a population recently fitted with mechanical~     heart valves.~   "
232963|NCT00506857|"~     Objectives:~        1. To determine the relative toxicities, engraftment potential, kinetics of engraftment,~          degree of chimerism and disease control achieved with the combination of fludarabine and~          busulfan at different dose levels and different dose schedules in patients undergoing~          allogeneic stem cell transplant (SCT).~        2. Determine pharmacokinetics, and toxicity of intravenous busulfan given at equal total~          dose levels given four times daily, or once daily.~        3. In vivo determination of fludarabine inhibitory effects on DNA repair.~   "
232964|NCT00506844|"~     This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and~     capecitabine concurrent with radiotherapy given preoperatively in patients with resectable~     rectal cancer.~   "
232965|NCT00506831|"~     Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis of the skin and~     internal organs and widespread vasculopathy. Patients with SSc are classified according to~     the extent of cutaneous sclerosis: patients with limited SSc have skin thickening of the~     face, neck, and distal extremities, while those with diffuse SSc have involvement of the~     trunk, abdomen, and proximal extremities as well. The disease course varies depending on the~     subtype of SSc. However, common features that result in significant morbidity and mortality,~     in addition to cutaneous fibrosis, include Raynaud's phenomenon and digital ulcerations,~     interstitial lung disease (ILD), and pulmonary arterial hypertension (PAH). Current~     therapeutic options for patients with SSc and these clinical manifestations have shown~     limited efficacy.~      Imatinib antagonizes specific tyrosine kinases that mediate fibrotic pathways involved in the~     pathogenesis of SSc, including c-Abl, a downstream mediator of transforming growth factor~     (TGF)-beta, and platelet derived growth factor (PDGF) receptors. The efficacy of imatinib has~     also been reported in the treatment of patients with refractory idiopathic PAH through its~     effects on vascular remodeling. Based on the mechanism of action and preliminary patient~     data, we hypothesize that imatinib may be effective in the treatment of the fibrotic and~     vasculopathic features of patients with SSc. This is an open label pilot study to evaluate~     the safety and efficacy of imatinib in patients with progressive SSc refractory to other~     treatment(s). Validated measures of skin thickness and disease activity will be determined~     over 6-months of therapy and compared with baseline measures.~   "
232966|NCT00506818|"~     Cognitive and emotional symptoms are often seen in the acute phase of a stroke. The~     prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully~     known. The causes of poststroke dementia are likely to be multifactorial (Cerebrovascular~     Diseases 2006). The investigators want to include all patients with first ever stroke without~     significant cognitive decline prior to the stroke (IQCODE cut-off 3,7) and follow them up for~     one year. At baseline we will make stroke classifications, measure neurological deficits~     according to NIHSS, evaluate cognitive and emotional function and make registrations of~     vascular risk factors, including precerebral color duplex scan with measurement of IMT in~     CCA. The investigators will then randomize the patients into multifactorial~     vascular-risk-factor-intervention in the hospital or care as usual in the primary health~     care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate~     neurological, cognitive and emotional functions, as well as MRI and SPECT.~   "
232967|NCT00506805|"~     Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an~     experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in~     patients with cancer.~   "
232968|NCT00506792|"~     This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic~     response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.~   "
232969|NCT00506779|"~     Objectives:~        -  To determine the maximum tolerated dose (MTD) of imatinib mesylate in combination with~          fixed dose paclitaxel in patients with stage IIIC, IV or recurrent uterine papillary~          serous carcinoma.~        -  To determine the nature and degree of toxicity of imatinib mesylate and paclitaxel in~          this cohort of patients.~        -  To determine the efficacy of imatinib mesylate and paclitaxel in patients with stage~          IIIC, IV or recurrent uterine papillary serous carcinoma whose tumor expresses either~          c-Kit, PDGFR or abl.~   "
232970|NCT00506766|"~     This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training~     (PFMT) and Bladder Training (BT) in women aged 55 and older.~   "
232971|NCT00506753|"~     This study will focus on treating substance abusing incarcerated teens using individually~     administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy~     (CBT). The control group receives individualized Relaxation Training (RT) followed by group~     Treatment as Usual (TU). Currently, there is little research regarding effective group~     treatments for incarcerated teens and this study will address this gap in our knowledge base.~     We seek to reduce substance use and associated risky behaviors post-release (including~     driving under the influence, risky sexual behaviors, etc.)~   "
232976|NCT00506688|"~     The majority of cystic fibrosis (CF) patients die from a progressive pulmonary disease.Airway~     inflammation plays a major role for the pathogenesis of CF lung disease, and ultimately leads~     to lung destruction. The release of oxidants during the inflammation process leads to a~     chronic imbalance of oxidants and antioxidants and may be a central component leading to~     irreversible lung damage in CF patients. The antioxidant glutathione, which is a naturally~     occurring tripeptide, is depleted in the extracellular epithelial lining fluid of the CF~     lung. The elevation of reduced level to normal and also the augmentation of glutathione~     concentrations above the normal level, as observed in smokers and during defence of~     Pseudomonas infection, may be desirable to avoid lung damage. Data from pilot studies in~     humans and animals have indicated that the glutathione concentrations in epithelial lining~     fluid can be elevated by aerosol application.~      The main objective of this trial is to evaluate the effect of a 24-week treatment with~     inhaled glutathione compared with control inhalations (normal saline) on pulmonary function~     in adult and pediatric CF patients. Secondary objectives are to determine the effects of~     inhaled glutathione on inflammatory variables, glutathione levels and free elastase in~     induced sputum and to evaluate the safety and tolerability of the 24-week treatment with~     inhaled GSH.~      There is considerable hope within the CF community that the addition of anti-oxidative~     therapy to an already comprehensive program for treating the lungs will decrease morbidity~     and improve the quality of life for patients with CF.~   "
232977|NCT00506675|"~     This study is designed to evaluate the effectiveness of treatment of residual amblyopia in~     children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The~     study is a randomized clinical trial comparing intensive treatment (42 hours per week of~     patching plus daily atropine) with a control group that will have rapid weaning of existing~     treatment followed by spectacle correction only (if needed). The primary objective is to~     determine if this intensive treatment will improve visual acuity in patients with residual~     amblyopia.~      The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.~      The primary analytic approach for the amblyopic eye acuity will be a treatment group~     comparison of the proportion of patients with at least two lines of visual acuity~     improvement.~   "
232978|NCT00506662|"~     This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once~     daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with~     type 2 diabetes naive to previous insulin therapy.~   "
232979|NCT00506649|"~     To assess pain, agitation, and delirium experienced by critically ill patients daily and~     evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of~     stay, mortality and costs of care between pre- and post-protocol groups.~   "
232980|NCT00506636|"~     This study is to try to maintain cultured dermal papilla cells in spherical structure in~     vitro before transplanting into dermis in vivo. Also, this study is aimed in clarifying~     actual mechanism of inducing hair follicle by dermal papilla cells.~   "
232981|NCT00506623|"~     This study is to evaluate the pathologic complete response rate to pre-operative concurrent~     chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer~   "
232982|NCT00506610|"~     The purpose of this study is to determine whether T-62 is effective in providing relief of~     pain that can occur after an individual experiences a shingles outbreak, which is an~     infection in adults caused by the same virus that causes chicken pox.~   "
232983|NCT00506597|"~     The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase~     (Erwinase®) as a replacement for patients who are allergic to E.coli L-asparaginase or~     Pegylated E.coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia~     (ALL) or T or B cell lymphoma.~      This trial was part of a multi institutional effort by the drug company to make Erwinase~     available for use.~   "
232984|NCT00506584|"~     The purpose of this study is to determine whether very low birth weight infants (less than or~     equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and~     human milk-derived nutrition have better health outcomes than babies fed at least some~     formula (made from cow's milk)or formula-derived nutrition.~   "
232985|NCT00506571|"~     Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on~     day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a~     planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed~     every 2 cycles of chemotherapy.~   "
232986|NCT00506558|"~     The purpose of the study is to determine the optimal surgical approach (ventral versus~     dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no~     established guidelines for the management of patients with CSM, which slowly causes spinal~     cord injury in afflicted patients.~      This study aims to test the hypothesis that ventral surgery (decompressing the spinal cord~     from the front of the neck) and dorsal surgery (decompressing the spinal cord from the back~     of the neck) might differ in their overall outcome or major complication rate.~   "
232987|NCT00506545|"~     This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH~     619734 in subjects with chronic cough from an unknown cause. Subjects will be randomized to~     receive SCH 619734 or placebo for 7 days with 7 days' follow-up. After a 6 week washout~     period, subjects will be crossed over to the other treatment. The primary objective is to~     evaluate the effectiveness of SCH 619734 in reducing cough reflex sensitivity as determined~     by a challenge with capsaicin, an agent that induces cough.~   "
232988|NCT00506532|"~     1. Working Hypothesis:~           The purpose of the trial is to study the effect of exogenous calf surfactant~          (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung~          injury in lung transplant patients.~        2. Aims of the Study:~      The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on~     the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung~     transplant patients.~   "
232989|NCT00506519|"~     The primary objective of the study is to explore the efficacy and safety of ATryn®~     (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC)~     associated with severe sepsis, when administered by continuous intravenous (IV) infusion over~     five days.~   "
233454|NCT00500344|"~     CNV from AMD is the leading cause of blindness in people over 50 in North America. The~     hypothesis is to determine if there is an improvement in retinal function determined by ERG~     following treatment with ranibizumab for AMD~   "
232990|NCT00506506|"~     N-acetylcysteine is used to reduce the risk of injury to the kidney after the administration~     of contrast dye. The mechanism and effectiveness of this intervention is not substantiated in~     the literature. The investigators hypothesize that serum creatinine will be lower in patients~     who receive NAC compared to those who receive the placebo but serum cystatin C will not~     change in patients who receive NAC compared to those who receive the placebo. Also urine~     creatinine will increase after the administration of NAC compared to before the~     administration of NAC.~   "
232991|NCT00506493|"~     This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the~     outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery~     plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The~     trial population includes patients requiring valve replacements or repairs, atrial septal~     defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft~     (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate~     Surgical Ablation System can safely and effectively treat persistent AF patients.~   "
232992|NCT00506480|"~     The purpose of this study is to determine whether endometrial receptivity markers obtained by~     endometrial sampling are effective in prediction of in vivo human embryo implantation.~   "
232993|NCT00506467|"~     Primary Objective:~        -  To estimate the accuracy of the pre-operative VRI QRF (Quantitative Regional Function)~          results versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung~          Ventilation and Perfusion) pre-operative scan.~      Secondary Objective:~        -  To assess the correlation of the predicted post-operative lung function with the~          observed post-operative lung function (FEV1 and DLCO) in patients who underwent surgical~          resection. (FEV1 = Forced expiratory volume in 1-second. DLCO = Diffusion capacity for~          carbon monoxide. ppo = predicted postoperative.)~   "
232994|NCT00506454|"~     The purpose of this study is to determine whether a phospholipid emulsion is effective in the~     treatment of chronic endotoxemia in hemodialysis patients.~   "
232995|NCT00506441|"~     This is a phase III multi-centre study in three periods: the first period is a phosphate~     binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the~     third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.~   "
232996|NCT00506428|"~     The purpose of this study is to examine the consequences of chronic sleep restriction on~     nighttime sleep, daytime alertness, performance and memory functions, and metabolic and~     cardiovascular function, and to determine if the consequences of chronic sleep restriction~     differ between healthy young and older adults.~   "
232997|NCT00506415|"~     The purpose of this study was to support the optimal use of rivastigmine patch in long-term~     treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline~     at the target maintenance dose of rivastigmine patch 10 cm^2.~   "
232998|NCT00506402|"~     The main objectives of this study are to evaluate the side effects of MKC-1 and to determine~     a safe dose of MKC-1 for future studies in patients with hematological malignancies~   "
232999|NCT00506389|"~     The purpose of this trial is to investigate the efficacy, safety and tolerability of~     esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.~   "
233000|NCT00506376|"~     The primary objective of this study is to assess the preferences (values and utilities) of~     women for complications and recurrences associated with the surgical treatment of cervical~     cancer. A secondary objective of this study is to compare the preferences of women at~     high-risk for developing cervix cancer with the preferences of women who have already been~     diagnosed with cervix cancer.~   "
233001|NCT00506363|"~     The appearance of skin after surgery plays an important role in patient's self confidence and~     life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in~     predisposed individuals after surgery. Among different kind of lasers, used to improve the~     appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully~     in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture,~     and elasticity of scars. Also, treatment with this technique is noninvasive, minimally~     uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of~     different onset times of treatment with pulsed dye laser on improvement of surgical scars.~   "
233002|NCT00506350|"~     The present study is designed to evaluate the reactogenicity and immunogenicity of one or two~     booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults~     aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate~     vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634)~     will be recruited. This protocol posting deals with objectives & outcome measures of the~     booster phase. The objectives & outcome measures of the primary phase are presented in a~     separate protocol posting (NCT00309634)~   "
233003|NCT00506337|"~     With multicenter randomized control clinical evaluation investigations, the scheme of~     integrated medicine treatment of severe acute pancreatitis (SAP) was further improved, and~     the therapeutic effects, safety and indications assured. Drawing in latest research fruits at~     home and abroad, a clinical practical guideline for integrated medicine of diagnosis and~     treatment of SAP would be formed, to be popularized all over China.~   "
233040|NCT00505843|"~     In this clinical trial, the safety of MK0657 when given with levodopa will be assessed in~     patients with Parkinson's Disease. This study will also measure the effectiveness of MK0657,~     when given in combination with levodopa, to improve motor symptoms and ameliorate dyskinesias~     (uncontrolled movements of a part of the body) as compared to placebo.~   "
233051|NCT00505700|"~     The primary objective of this study is to establish the maximally tolerated dose of VELCADE~     that can be administered with idarubicin and cytarabine in patients with AML. The secondary~     objectives of this study are assessment of efficacy, safety, and pharmacokinetics of Velcade~     when combined with Cytarabine and idarubicin. Various molecular markers associated with~     response to Velcade, cytarabine, and idarubicin will be explored by utilizing microarray~     analyses. The study endpoints are maximum tolerated dose and response to treatment.~   "
233052|NCT00505687|"~     The objective of this open-label extension is to assess the safety and tolerability of~     long-term treatment of rotigotine in subjects with idiopathic PD.~   "
233004|NCT00506324|"~     This project defines the effect on swallowing of intensity modulation during radiotherapy in~     an organ preservation treatment involving chemoradiation for 125 oral, laryngeal, and~     pharyngeal cancer patients with previously untreated Stage III or IV disease and to identify~     optimum treatment strategies. The specific aims are: 1) define the physiologic effects of~     chemoradiotherapy with IMRT to various sites in the upper aerodigestive/vocal tract including~     the cervical esophagus and the rate at which patients return to oral intake; 2) document the~     acute toxicities, late complications, locoregional failure and survival, and the relationship~     between fibrosis rating and the measure of laryngeal elevation; 3) determine whether the~     patient's swallowing mechanism can compensate for physiologic deficits in swallowing by~     introduction of interventions (postural changes, voluntary swallow maneuvers, several bolus~     volumes); 4) determine whether time to return to oral intake, effects of swallow maneuvers~     and/or volume, presence of an esophageal stricture and the duration of success of dilatation~     depends on radiation dose volume to specific structures in the head and neck; 5) define the~     relationship of tongue base pressure to development of esophageal stricture. Patients will be~     accrued from Northwestern University and University of Chicago. Effects are defined in terms~     of swallowing function, morbidity, toxicity and survival. Other outcome measures are the~     maintenance of voluntary control (flexibility) of the oropharyngeal region as indicated by~     the ability to correctly produce swallow maneuvers; and positive changes in cricopharyngeal~     opening duration with normal bolus volume shifts. Patients will be studied pretreatment, and~     at 1 month, 3 months, 6 months, 12 months, and 24 months post completion of chemoradiation.~     At each assessment, patients will receive a videofluoroscopic assessment of swallowing~     utilizing a standard protocol, assessment of xerostomia, mucositis, and fibrosis as well as~     assessment of disease status and quality of life scales. Head and neck cancer is a severe~     problem that affects public health. Most current treatments are a combination of radiotherapy~     with chemotherapy, which can result in severe swallowing problems which may make patients~     unwilling to accept this type of treatment. This project attempts to quantify the swallow~     problems associated with this specific treatment and the effects of interventions for these~     swallow problems.~   "
233005|NCT00506311|"~     Primary Objective:~      1. To determine whether the use of a fibrin sealant applied to superficial groin soft tissues~     following node dissection can result in decreased cumulative postoperative drainage, earlier~     drain removal, and lower incidence of seroma.~      Secondary Objectives:~        1. To determine the postoperative morbidity rate using fibrin sealant following superficial~          groin dissection.~        2. To assess patient-valuation of outcome by performing a cost-benefit analysis using a~          willingness-to-pay model.~        3. To determine if serum levels, lymphatic fluids level, or cutaneous expression of~          vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C~          (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3)~          correlates with nodal tumor burden or development of lymphedema in patients with~          melanoma.~   "
233006|NCT00506298|"~     This trial will assess the efficacy of CRx-401 in lowering FPG levels in patients taking~     metformin to treat their diabetes. In addition, this initial trial will evaluate insulin~     resistance (HOMA-IR index), HgbA1c levels, glycated protein, LDL, HDL, triglycerides, and~     total cholesterol, as well as the safety of CRx-401.~   "
233007|NCT00506285|"~     This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in~     treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first~     trial for adult ADHD. Subjects will experience two screening visits and one baseline visit.~     Those who meet admission criteria will enter the double-blind phase. This will involve two~     4-week treatment periods one of which will involve the use of MTS and the other a placebo~     patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day,~     open-label MTS phase designed to assess long-term effects.~   "
233008|NCT00506272|"~     ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes~     mellitus by selected patients admitted for elective surgery is more efficacious than standard~     care with respect to overall glycemic control, attaining finger-stick blood sugars, and~     administering insulin.~   "
233009|NCT00506259|"~     This study will examine the effect of bright light or melatonin treatment on sleep in~     children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain~     physical, behavioral and developmental features. Patients have a disrupted sleep cycle~     involving early waking, frequent daytime napping and frequent nighttime awakenings. Melatonin~     is a hormone normally produced at night in healthy people. People with SMS produce high~     levels of melatonin during the daytime and very low levels at night. This may affect their~     behavior, mood, attention span and sleep patterns.~      Healthy volunteers between 18 and 45 years of age and children with SMS who are between 3 and~     16 years of age may be eligible for this study.~      Healthy subjects are admitted to the NIH Clinical Center overnight. In the morning they take~     one dose of time-release melatonin and have blood and saliva samples collected hourly from~     7:00 AM to 6:00 PM.~      Children with SMS participate in a 2-part study, as follows:~      Part 1 Inpatient Trial~      Pre-trial at-home phase: During the month before NIH inpatient admission, participants do the~     following:~        -  Wear an actiwatch device or keep a daily sleep diary to monitor daytime alertness, mood~          shifts and sleep patterns.~        -  Complete a behavior assessment survey related to the child s behaviors and sleep~          patterns.~        -  Obtain frequent body temperature measurements.~        -  Collect several saliva samples over a 24-hour period.~      NIH admission phase:~        -  Children are admitted to the NIH Clinical Center for 2-3 nights for bright light~          treatment. They remain in their rooms for alternating periods of exposure to standard~          dim room light and bright light, using a light box placed within 3 to 5 feet of the~          child. An electroencephalogram (EEG) with additional electrodes to track eye movements~          is used to monitor the child s attention. Between 8AM and 6PM serial blood samples are~          collected to measure melatonin levels. A parent rates the child s mood and behavior~          during the 2-day test period.~        -  Children are admitted to the NIH Clinical Center for 2-3 nights for melatonin treatment.~          They take a single dose of melatonin or placebo tablet at bedtime. During the daytime,~          EEG electrodes are placed to track eye movements. Between 7 PM and 7 AM serial blood~          samples are collected to measure melatonin levels. A parent rates the child s behavior~          and mood as described for the bright light study.~        -  Children may receive either or both of the bright light and melatonin treatments.~      Part 2 Outpatient Trial~      Children participate in a combined bright light with melatonin trial at home. They undergo~     the same procedures outlined in the pre-trial at-home phase of Part 1 (actiwatch, behavior~     assessments, body temperature measurements, saliva samples) over an 11-week period. If saliva~     samples cannot be collected for melatonin testing, 24-hour urine samples may be collected~     instead.~   "
233010|NCT00506246|"~     The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and~     safety during total intravenous anaesthesia~   "
233011|NCT00506233|"~     Primary Objective:~      1. To determine the feasibility of conducting a multi-site longitudinal observational study~     of patients with chronic graft-versus-host disease (GVHD).~   "
233012|NCT00506207|"~     This study is an open-label, single center, and a dose-escalating phase I study to determine~     the maximal tolerated dose and the recommended dose of S-1 combined with~     irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric~     carcinoma.~   "
233013|NCT00506194|"~     We designed this prospective, randomized control study to compare the benefits between the~     insulin therapy and OADs after correction of the glucose toxicity with a short period of~     intensive insulin therapy.~   "
233014|NCT00506181|"~     Medical literature has dealt with various perspectives of probiotic therapy - prevention of~     antibiotic associated diarrhoea, Clostridium difficile, etc.~      However, there have been no published results which can provide a basis for a generalized~     recommendation or discouragement of probiotic use among various groups of hospitalized~     patients.~      The hypothesis is that the benefit in probiotic therapy in the admitted patient is by far~     larger than the actual cost of therapy. This assumption is probably true for all admitted~     patients and for patients on antibiotic therapy in particular.~   "
233015|NCT00506168|"~     This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan~     and capecitabine in previously untreated metastatic colorectal cancer.~   "
233016|NCT00506155|"~     The goal of this clinical research study is to learn how well bladder cancer responds to a~     combination treatment with Avastin and M-VAC (methotrexate, doxorubicin, vinblastine, and~     cisplatin) before surgery to remove the tumor.~      Primary Objective:~      To estimate the response of patients with locally advanced urothelial cancer treated with~     neoadjuvant chemotherapy with a combination of Dose Dense Methotrexate, Vinblastine,~     Adriamycin, and Cisplatin (DD-M-VAC) plus Avastin followed by radical surgery with curative~     intent. In this context, response will be defined as the absence of residual muscle invasive~     cancer in the resected specimen (<= pT1, N0.)~      Secondary Objective:~      To estimate the 4-year disease-free survival of patients with locally advanced urothelial~     cancer treated with neoadjuvant chemotherapy with DD-M-VAC plus Avastin followed by radical~     surgery with curative intent.~      Document perioperative morbidity and mortality in this cohort, with reference to~     well-established historical standards.~      Determine the effects of VEGF inhibition on angiogenesis and angiogenesis-related gene~     expression utilizing fluorescent tissue staining techniques that we have developed in the~     laboratory (such as two-color TUNEL, phospho-receptor, and microvessel density).~      Interrogate downstream receptor signaling pathways to provide insight into the development of~     chemotherapy resistance, and hence hypothesis for its prevention.~   "
233017|NCT00506142|"~     Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed~     to interfere with the multiplication of cancer cells, which may slow or stop their growing~     and spreading throughout the body. This may cause the cancer cells to die. Liposomal~     vincristine is formed when vincristine is placed inside of oil droplets called liposomes,~     which may help to improve the delivery of drug to the tumor site. The liposomal formulation~     results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer~     cells to vincristine continuously.~      The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can~     help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be~     studied.~      Approximately 50 patients will take part in this study.~   "
233018|NCT00506129|"~     The goal of this clinical research study is to see if receiving a transplant of blood stem~     cells (cells that can produce blood) or bone marrow from either a related donor (brother,~     sister or other relative) or an unrelated voluntary donor will help patients with advanced~     cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain~     free of disease will also be studied.~   "
233019|NCT00506116|"~     The purpose of this study is to determine whether pushing during labor that is controlled by~     the woman results in less birth-related injury and less postpartum urinary incontinence (UI).~   "
233020|NCT00506103|"~     To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel~     (HS) in terms of the operating time and complications in total thyroidectomy with central~     neck dissection (CND). Recently, the HS has been used as an alternative to conventional~     hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure.~     Very limited data have been published on evidence of its safety in total thyroidectomy~     accompanied by CND without supplementary hand-tied ligation.~   "
233021|NCT00506090|"~     The appearance of skin after surgery plays an important role in patient's self confidence and~     life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in~     predisposed individuals after surgery. Among different kind of lasers, used to improve the~     appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully~     in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture,~     and elasticity of scars. Also, treatment with this technique is noninvasive, minimally~     uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of~     different intervals of pulsed dye laser sessions on improvement of surgical scars.~   "
233022|NCT00506077|"~     The purpose of this study is to determine the safety and effectiveness of an investigational~     drug MK0249 for the treatment of the cognitive impairment in patients with schizophrenia.~   "
233023|NCT00506064|"~     Primary Objective:~      To evaluate the impact of postoperative exogenous nocturnal melatonin supplementation on the~     early regulation of the sleep-wake cycle and its clinical impact (subjective improvement of~     the quality of sleep and reduction of cardiopulmonary events) during the first postoperative~     week following anesthesia and surgery in older breast cancer patients receiving a unilateral~     segmental mastectomy with or without intraoperative lymph node mapping, sentinel node biopsy~     and axillary node dissection.~      Secondary Objective:~      To collect data and validate the Postoperative Srejic Sleep SAT Survey Questionnaire (SAT~     implies relative subjective satisfaction of the patient's sleep in a scaled score out of 100~     with 100 being the highest degree of satisfaction).~   "
233024|NCT00506051|"~     The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets)~     to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help~     control their symptoms and disease better than the chemotherapy alone.~   "
233025|NCT00506038|"~     Background: Calcific tendinitis of the rotator cuff may cause chronic pain at the shoulder.~     Sometimes the pain can lead to a serious impairment in the daily life.~      One of the most efficient treatments is percutaneous needle aspiration using ultrasound~     guidance.~      This treatment includes identification the tendonitis with US or screening , local anesthesia~     and then puncturing the calcium in the rotator cuff many times. The treatment is short 5-10~     minutes, relatively cheap ,safe and usually with good outcomes. However in the literature~     there is a lack of controlled prospective trials.~      Our goal is to set a study that will evaluate this treatment between two groups:~        1. Puncturing the calcium in the rotator cuff 15 times (the experiment group)~        2. Puncturing the calcium in the rotator cuff twice (the controlled group)~   "
233026|NCT00506025|"~     This study is to help determine if drinking cranberry juice can decrease risk for~     asymptomatic bacteriuria (ASB). ASB occurs when there are bacteria in the urine without any~     symptoms. It will also see if there is a difference in this effect between pregnant and~     non-pregnant women.This research project is also designed to see what happens to bacterial~     binding to the lining of the bladder after drinking cranberry juice when special problems~     occur with pregnancy such as diabetes (a sugar metabolism problem) or ASB is already~     occurring.~   "
233027|NCT00506012|"~     This pilot study will evaluate the safety and efficacy of once daily T2000 when used to treat~     patients with Myoclonus Dystonia over a 12 week period.~   "
233028|NCT00505999|"~     Objectives:~      The overall objective of this project is to identify risk factors associated with the~     development of multiple myeloma (MM) by integrating epidemiologic, clinical and molecular~     information. We plan to invite MDACC patients with MM, as well as controls, to participate in~     this investigative case-control study. Controls will be selected from friends and spouses who~     accompany patients to the various MDACC clinics and will be matched to the cases on age (±5~     years), gender, and ethnicity. We will obtain demographic, risk factor and clinical~     information along with a blood and buccal sample from all cases and controls. This study~     could have implications for prevention and subsequent reduction in the incidence of multiple~     myeloma. Collecting blood and buccal samples will allow us to study the role genetic~     susceptibility plays in MM risk. The specific aims are:~        1. To enroll and obtain, through self-administered questionnaires, risk factor information~          on all study participants to develop detailed demographic, epidemiologic, and behavioral~          profiles. This study will accrue 250 MM patients from MDACC and 250 healthy controls~          selected from friends and spouses who accompany patients to the MDACC clinics. Blood (25~          ml) and buccal samples will be collected from all participants.~        2. To identify risk factors associated with MM by integrating epidemiological, clinical and~          molecular information using a case-control approach.~        3. To evaluate constitutional markers of genetic susceptibility as predictors of MM risk.~          Gene-environment interactions will be explored.~   "
233029|NCT00505986|"~     Determine if different genomic endometrial expression exists during embryo implantation in~     obese women in comparison with non obese women.~   "
233030|NCT00505973|"~     This study is being conducted to assess the safety and tolerability of ascending multiple~     oral doses of SCA-136 administered to healthy Japanese male subjects.~   "
233031|NCT00505960|"~     The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored,~     comprehensive behavioral intervention program specially designed for linguistically~     challenged ethnic minority immigrant populations (Korean Americans) with type 2 DM.~   "
233032|NCT00505947|"~     The purpose of this study is to determine if treatment with infliximab improves macular edema~     which is refractory to laser photocoagulation in patients with diabetes.~   "
233033|NCT00505934|"~     Keppra injection is approved in the US as adjunctive therapy in the treatment of partial~     onset seizures in adults with epilepsy. The objective of the current study is to assess the~     safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4~     years.~   "
233034|NCT00505921|"~     Primary Objectives:~        1. To evaluate the role of autologous and allogenic stem cell transplantation with~          Campath-1H for patients with peripheral T-cell lymphoma (PTCL).~        2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem~          transplantation for patients with PTCL.~        3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.~        4. To evaluate the role of Campath -1H in the treatment minimal residual disease after~          autologous transplantation for PTCL.~   "
233035|NCT00505908|"~     Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain~     injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical~     interventions, intensive care monitoring and overall supportive management, many of those who~     do survive do not fully recover and are left with a varying degree of permanent disability.~     It is therefore imperative that new methods of early interventions be explored.~      One possible road to effective therapy is to examine the timing of secondary injury via a~     biological marker, to help guide the timing of treatment directed specifically at early~     oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow~     us to direct appropriate therapies targeted directly at oxidant injury within what is~     currently thought to be a very narrow window of opportunity for intervention, possibly~     peaking within the first two hours after the initial injury.~      Potential participants include patients between the ages of 18 and 50 years who are admitted~     to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood,~     urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected~     over the first 5 days post-injury. Clinically-relevant patient progress, clinically required~     interventions, neuro-imaging results, and demographics will be tracked while the patient is~     hospitalized, with final neurological outcome measured at 3 months.~   "
233036|NCT00505895|"~     The goal of this clinical research study is to learn if there is a difference in transplant~     outcomes between two different doses of melphalan given in combination with fludarabine~     followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone~     marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma.~     This study will also look at whether treatment with a antibody called rituximab against a~     specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host~     disease after transplant. The safety of these treatments will also be compared.~   "
233037|NCT00505882|"~     In this pilot study we are evaluating the efficacy of pramlintide on preventing weight gain~     among early onset type 1 diabetes. We are also evaluating the safety and the effects of~     treatment with pramlintide on early diagnosed type 1 diabetic subjects, especially among~     pediatric subjects.~   "
233038|NCT00505869|"~     This proposal is aimed at testing the following hypotheses:~        1. Cessation rates will be significantly greater for smokers in a mood management condition~          versus a health & wellness condition during pregnancy and at 3 and 6 months postpartum.~        2. Pregnant smokers who have a higher level of depressive symptomatology will quit~          significantly less often in the health & wellness condition vs. mood management~          condition; those with a lower level of depressive symptomatology will not demonstrate~          this treatment difference.~        3. Pregnant smokers who show higher levels of current depression at the start of the~          intervention will quit significantly less often than those smokers with lower levels.~      The mood management intervention will result in higher levels of adaptive coping behavior,~     self-efficacy, social support, and perceived support from the counselor, and lower levels of~     negative affect, rumination, and perceived stress, than the health & wellness intervention~     and these variables will be related to abstinence. Thus, we will evaluate the effects of the~     intervention (health & wellness and mood management) on hypothesized treatment mechanisms,~     and assess the impact of those mechanisms on abstinence.~   "
233039|NCT00505856|"~     The use of dermabond skin adhesive vs. skin staples for the closure of repeat c-section~     incisions.~   "
233041|NCT00505830|"~     Autism is considered as an invading disorder of the development. Asperger Syndrome (AS) is a~     particular form of autism and is difficult to diagnose. The Autism Spectrum Quotient (AQ) has~     been developed in order to measure the degree of autistic traits in autistic adolescent with~     normal intelligence (Baron-Cohen et al. 2001, 2006). AQ comprises 50 questions, with 5 groups~     of 10 questions assessing imagination, social skills, attention switching, attention to~     detail and communication skills. Each of these items scores 1 point if the respondent records~     abnormal or autistic like behaviour. The minimum score on the AQ is 0 and the maximum 50.~      The principal objective of this study is to evaluate the accuracy of the French version of~     Autism Spectrum Quotient questionnaire.~      Secondary objectives are to:~      Evaluate if EQ and SQ can distinguish adolescents without psychiatric syndromes from those~     with classical autism or AS.~      Evaluate if AQ, EQ and SQ can distinguish adolescents with psychiatric disorders from~     autistic adolescents.~      Define the threshold of positivity for the 3 questionnaires.~   "
233042|NCT00505817|"~     The primary purpose of this study is to evaluate the effect of the two different protocols~     (long protocol vs antagonist protocol) on oocyte / embryo quality.~   "
233043|NCT00505804|"~     The purpose of the study is to determine whether dexmedetomidine is a more effective~     medication than haloperidol in the treatment of agitation and delirium in patients receiving~     mechanical ventilation in an intensive care unit. Haloperidol is a medication conventionally~     used for this purpose.~      The investigators will study only patients who have recovered from their illness to the point~     that, were it not for agitation and delirium, they would no longer require mechanical~     ventilation.~      The investigators hypothesize that patients receiving dexmedetomidine will be able to~     discontinue mechanical ventilation earlier than those receiving haloperidol.~   "
233044|NCT00505791|"~     Heart failure (HF) is a disease that is caused by a reduced heart muscle function. Reduced~     heart muscle function can occur as a consequence of reduced pumping activity from a weak~     heart muscle or because of a stiff heart muscle. This study is looking at the effectiveness~     of Natrecor (nesiritide) in patients that require hospitalization due to worsening heart~     failure as a result of a stiff or thickened heart muscle. Natrecor is a man-made version of a~     protein that my body makes on its own and has been approved for the treatment of patients~     requiring hospital admission for heart failure and have shortness of breath at rest or with~     minimal activity.~      Natrecor has shown to lower the pressures in the heart and decreases the congestion in the~     lungs. This study is being done to see if the addition of a Natrecor to standard medical~     therapy for HF will improve symptoms faster or more completely than giving only the standard~     treatment for CHF.~   "
233045|NCT00505778|"~     The purpose of this study is to compare the efficacy in maintaining remission of ulcerative~     colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol~     dosing regimen.~   "
233046|NCT00505765|"~     The TURNS is a NIMH-funded contract for the evaluation of new compounds for the treatment of~     cognitive impairments in schizophrenia (HHSN 27820044 1003C; P.I.: Steve Marder, M.D.).~     Despite advances in the safety, tolerability, and effectiveness of antipsychotic medications~     for the treatment of schizophrenia, many patients continue to be plagued by impairments in~     social and work functioning. Persons with schizophrenia commonly show deficits in a number of~     areas of cognition that include impairments in attention, memory, and executive functioning~     (the ability and organize one's behavior). Importantly, a large body of literature now shows~     a link between cognition and community functioning in schizophrenia. It is believed that~     treatments that improve cognitive deficits may lead to improvements in work and social~     functioning.~      One approach to improve the community functioning of patients with schizophrenia is to~     develop new agents that treat the cognitive deficits of the illness. A promising agent is~     called AL-108. This drug is administered as a nasal spray. Studies in animals suggest that~     this drug may protect neurons and may improve cognition in schizophrenia. The current study~     is a twelve-week multicenter, double-blind, randomized clinical trial of two doses of AL-108~     (5 and 30 mg/day intranasally) versus placebo in the treatment of persistent cognitive~     dysfunction in schizophrenia. The study medication will be added to patients' current~     atypical antipsychotic medication or to their current injectable first-generation~     antipsychotic medication. The primary outcome measure will consist of the composite score of~     the MATRICS neuropsychological battery. Secondary outcome measures will include scores on~     symptoms, functional outcome, and safety measures. Sixty clinically stable patients with~     schizophrenia, drawn from eight sites, will participate in the study. Twenty-five patients~     will be enrolled at UCLA.~   "
233047|NCT00505752|"~     This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind,~     active-comparator, dose-finding study to evaluate a new investigational long-acting follicle~     stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive~     technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection~     [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently~     marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to~     the number of fertilized oocytes.~   "
233048|NCT00505739|"~     Primary Objectives:~        1. To determine the antitumor activity of Mifepristone (RU-486) in patients with advanced~          or recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma~          (LGESS).~        2. To evaluate the quantitative and qualitative toxicities of Mifepristone in this patient~          population.~        3. To evaluate at a tissue level the effect of Mifepristone on estrogen and progesterone~          receptors post treatment and to evaluate other markers that may reflect effects of~          Mifepristone on cancer cell growth.~        4. To evaluate the effect of the agent and dosing schedule on the patient's quality of~          life.~   "
233049|NCT00505726|"~     The goal of this clinical research study is to see if reflectance confocal microscopy works~     as well as standard methods to detect cancer of the cervix or precancerous lesions.~      Primary Objectives:~        1. To identify potential clinical advantages for a noninvasive method of diagnosing~          dysplasia and neoplasia in the cervix using reflectance confocal microscopy.~        2. To obtain real time reflected light images in vivo of sites in the human cervix.~        3. To access the effects of acetic acid as a contrast agent for in vivo reflectance~          confocal imaging.~        4. Evaluate the depth of penetration for the fiber optic confocal device and analyze the~          diagnostic value of images taken from different depths.~        5. Determine the sensitivity and specificity of this device for the diagnosis of CIN.~   "
233050|NCT00505713|"~     Rexin-G is a tumor-targeted (pathotropic or disease-seeking) nanoparticle that when injected~     intravenously, seeks out and accumulates in cancerous lesions, thus enhancing local drug~     concentration within tumors. The goal of the adaptive trial design is to confirm the over-all~     safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document~     the significant clinical benefits required to support a Phase II registration protocol.~   "
233943|NCT00493818|"~     This study is a first time in human, Phase I, open-label study to determine recommended doses~     and schedules, based on maximum tolerated doses and biologically active doses, for the AKT~     inhibitor GSK690693.~   "
233053|NCT00505661|"~     Primary Objectives:~        -  To determine the objective response rate of Letrozole when administered to patients with~          advanced or recurrent borderline tumors or low-grade epithelial cancers from the ovary ,~          fallopian tube or peritoneum.~        -  To determine the time to tumor progression of patients with advanced or recurrent~          borderline tumors or low-grade epithelial cancers from the ovary, fallopian tube or~          peritoneum.~        -  To identify the biological markers to predict response to Letrozole and study the~          aspects of the hormones in these types of tumors.~   "
233054|NCT00505648|"~     Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological~     study of the T cell index phenotype and functionality in hypersensitivity syndrome.~   "
233055|NCT00505635|"~     The goal of this clinical research study is to learn if treatment with Temodar~     (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A~     (interferon alpha), and thalidomide can help to control melanoma that has spread to other~     parts of the body. The safety of this treatment will also be studied.~   "
233056|NCT00505622|"~     This is a multicentre, open-label extension study to evaluate the long-term safety,~     tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated~     PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or~     E2007-G000-309 will be candidates for entering this extension trial, provided that they meet~     the inclusion/exclusion criteria and have completed the core study, up to and including the~     final efficacy visit.~   "
233057|NCT00505609|"~     The Standard Days Method® is a fertility awareness-based method of family planning in which~     users avoid unprotected intercourse during cycle day 8 through 19. The method is most~     appropriate for women with cycles that usually range 26-32 days. The clinical trial tested~     the contraceptive efficacy of the Standard Days Method. A total of 478 women, age 18-39~     years, in Bolivia, Peru, and the Philippines, with self-reported cycles of 26-32 days,~     desiring to delay pregnancy at least one year were admitted to the study and followed for up~     to 13 cycles of method use.~   "
233058|NCT00505596|"~     The proposed study will determine the impact of providing complete information about all~     prenatal tests for chromosomal disorders to racially/ethnically and sociodemographically~     diverse women of all ages and allowing them to make informed choices regarding which tests -~     if any - to undergo. Specifically, we propose to update a validated prenatal testing~     decision-assisting tool (PT Tool) to incorporate new screening options and make it more~     accessible to lower literacy and culturally diverse populations. We then will conduct a~     randomized controlled trial comparing the effect of an informed free choice approach~     consisting of providing complete information regarding and access to all prenatal testing~     options to that of usual care among a diverse population of pregnant women.~   "
233059|NCT00505583|"~     To evaluate the effects of single oral doses of MOA-728 compared to a positive control in~     subjects on methadone therapy.~   "
233060|NCT00505570|"~     The purpose of this study is to evaluate migraine headache frequency in subjects who have~     migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and~     left upper chambers (atria) of the heart which normally closes at or soon after birth) who~     are randomized to either undergo closure of the patent foramen ovale or continue with~     standard medical management.~   "
233061|NCT00505557|"~     The purpose of this study is to evaluate the feasibility and outcome of performing dual plane~     breast augmentation with assistant of endoscope by axillary approach.~   "
233062|NCT00505544|"~     Objectives:~      Primary Objectives:~        1. To establish concurrent criterion-related validity of the Brief Sleep Disturbance Scale~          (BSDS) by correlating the scale with the Pittsburgh Sleep Quality Index.~        2. To evaluate the construct validity of the BSDS through exploratory factor analysis.~        3. To examine possible predictors of sleep disturbance.~        4. To evaluate the reliability of the BSDS using Cronbach's coefficient alpha and~          test-retest reliability.~        5. To evaluate the sensitivity of the BSDS by administering it to the same group of~          patients (n = 60) prior to treatment with a regimen associated with sleep disturbance,~          during 4 weeks of treatment, and upon completion of treatment.~        6. To evaluate the psychometric properties of the BSDS in a sample of community dwelling~          adults.~      Secondary Objective:~      1. To obtain pilot data from a small sample of patients who will wear an actigraph for one~     week.~   "
233063|NCT00505531|"~     The Massachusetts General Hospital Center for Translational Pain Research is conducting a~     research study to see if Ultram ER, an FDA-approved pain medication, would be helpful in~     providing pain relief in subjects whose chronic pain is not well controlled on narcotic pain~     medicine.~   "
233064|NCT00505518|"~     The current use of telepsychiatry, or psychiatric care using videoconferencing, is very~     limited. The present study investigates the use of this method with a depressed Chinese~     American population in a nursing home. It is believed that this population can benefit from~     telepsychiatric treatment when used in collaboration with the primary care they receive in~     the nursing home.~   "
233065|NCT00505505|"~     Strict glycemic control improves mortality and morbidity of patients admitted to the~     postoperative intensive care unit (ICU). The investigators would like to know if this therapy~     could improve the long term neurologic and cognitive outcomes of patients treated for acute~     subarachnoid hemorrhage with either a surgical or intravascular approach.~   "
233066|NCT00505492|"~     Primary Objectives:~        1. To test whether the addition of chemotherapy to radiotherapy improves the~          progression-free survival for patients with stage I, II and IIIa malignant mixed~          mesodermal tumor (MMMT) of the uterus.~        2. To determine the acute and late toxicity profiles associated with this treatment~          regimen.~        3. To describe the effect of this treatment regimen on the patient's quality of life.~   "
233067|NCT00505479|"~     Iodine is an essential component of thyroid hormone, which is necessary for many metabolic~     processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious~     effects on both pregnant women and infants. The iodine status of the population after~     implementation of the universal salt iodization program in Zhejiang province has not been~     known. This study was to determine whether pregnant women show evidence of iodine deficiency,~     and to examine the correlation between maternal urine iodine concentration and newborn~     thyroid function.~   "
247512|NCT00313261|"~     The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg~     QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.~   "
233068|NCT00505466|"~     The goal of this study is to design a means of providing research families, from diverse~     geographical locations, the chance to receive genetic testing after having been educated by~     video, and meetings or telephone conversations with a genetic counselor/study professional.~      This is an investigational study. About 800 people will be offered genetic testing. This~     study is being performed only at MD Anderson.~   "
233069|NCT00505453|"~     Vaccination is currently the most effective means of controlling influenza and preventing its~     complications and mortality in persons at risk.~      Once a year, a meeting of WHO experts takes place, leading to a recommendation on the~     influenza A and B strains that should be used for the production of vaccine for the coming~     influenza season.~      This study is designed to test the safety/reactogenicity and the immunogenicity of the~     Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains~     recommended for the 2007-2008 season.~   "
233070|NCT00505440|"~     This is a study to find out which type of computer screening and nursing support can improve~     screening for high risk behaviors in doctor's offices. Recommendations call for doctors to~     screen young people for many different behaviors and feelings such as depression, not wearing~     seat belts, alcohol and drug use. Doctors rarely have time to complete these screenings. New~     computers can help ask some of these questions and protect patient information. In addition,~     nurse telephone calls can often help young persons with some of the behaviors receive~     treatment. This study will examine which type of computer screening and follow-up will help~     patients the most.~   "
233071|NCT00505427|"~     The study will recruit 40 subjects with Polycystic Ovary Syndrome (PCOS) as defined by the~     NIH criteria. The subjects will be pre-screened for insulin sensitivity using fasting insulin~     and glucose levels and oral glucose tolerance test. The 20 most insulin resistant subjects~     will undergo measurements of in vivo insulin action by hyperinsulinemic, euglycemic clamp.~     Body composition will be measured by dual-energy X-ray absorptiometry (DEXA). Plasma lipids~     and markers of oxidative stress will be measured. They will then receive open label~     controlled release alpha lipoic acid (CRLA) at 800 mg twice daily for 16 weeks. After~     treatment hyperinsulinemic euglycemic clamps, DEXA, plasma lipids and markers of oxidative~     stress will be repeated.~      Hypotheses: LA will improve insulin sensitivity in PCOS subjects; LA will reduce oxidative~     stress, testosterone levels and improve cardiovascular risk factors.~   "
233072|NCT00505414|"~     The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe~     in the treatment of chronic tumor related pain compared to placebo.~   "
233073|NCT00505401|"~     The development of a vaccine against HIV/AIDS has been primary focused on the structural~     proteins (Env, Gag) of HIV-1 with the aim of inducing sterilizing immunity by blocking virus~     entry. Alternative approaches are focused on new vaccine strategies aimed at modifying the~     virus-host dynamic favouring the establishment of a long-term non-progressing disease status.~     Such strategies target regulatory proteins that are the first to be expressed after infection~     and are essential for viral replication, infectivity and pathogenesis. Thus, this approach~     may be effective for both preventive and therapeutic vaccination strategies.~   "
233074|NCT00505388|"~     This patient follow-up programme was designed to describe the extent of Symbicort use in~     patients prescribed Symbicort as maintenance and reliever therapy in routine clinical~     practice in comparison with the already documented use of Symbicort as maintenance and~     reliever therapy in clinical therapies~   "
233075|NCT00505375|"~     The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in~     individuals with new onset T1DM will improve insulin secretion (C-peptide production)~     compared to placebo.~   "
233076|NCT00505362|"~     Suture reapproximation of the rectus muscles at primary cesarean delivery is a common~     practice about which there are no data. Some Obstetricians believe that suture~     reapproximation of the rectus muscles increases post-operative pain, and it may decrease~     adhesions, yet there are no published data to support or refute these claims. The purpose of~     this study is to assess the effect of rectus muscle reapproximation at cesarean delivery and~     post-operative pain. We also plan to assess the impact of rectus muscle closure on adhesions~     as seen at repeat cesarean delivery.~   "
233077|NCT00505349|"~     The overall goal of this study is to evaluate the impact of cognitive training on blood~     levels of neurotrophic factors in adults.~   "
233078|NCT00505336|"~     To investigate whether the medicines eplerenone or atorvastatin have a favourable effect on~     diastolic heart failure.~      Eplerenone is a drug that has been shown to be beneficial in Chronic Heart Failure due to~     pump failure. It can increase life expectancy and improve symptoms in these patients. It is~     not known whether or not eplerenone might be beneficial in heart failure with normal pump~     function (diastolic heart failure).~      Atorvastatin is one of a group of cholesterol lowering medicines called statins, which have~     been shown to reduce cardiovascular disease in patients irrespective of whether cholesterol~     levels are high or normal. It is not known whether atorvastatin also reduces fibrosis of the~     heart which is one of the causes of diastolic heart failure.~      Study hypothesis~        1. To investigate the impact of aldosterone antagonism or statin therapy on markers of~          collagen turnover in patients with diastolic heart failure.~        2. To assess the impact of aldosterone antagonism or statin therapy on markers of diastolic~          dysfunction and indices of clinical well being in patients with diastolic heart failure.~   "
233079|NCT00505323|"~     Dystonia is a neurological movement disorder in which sustained muscle contractions cause~     twisting and repetitive movements or abnormal postures. This disease is very heterogeneous~     and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary~     generalized dystonias; however they are ineffective for focal dystonias following brain~     damage.~      Cortex stimulation is a present and effective technique used in the treatment of chronic pain~     and could represent an interesting strategy to treat focal dystonias. This is the aim of the~     present study.~   "
233159|NCT00504231|"~     This randomized trial compared the immunogenicity of 60% dose intradermal (ID) influenza~     vaccination to standard intramuscular (IM) vaccination of full-dose or 60% dose vaccine. Pre-~     and postvaccination measurements in the hemagglutination inhibition antibody (HAI) titer were~     compared. Participants who received reduced-dose vaccine were revaccinated with full-dose IM~     vaccine.~   "
233455|NCT00500331|"~     This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a~     range of doses of investigational product and pioglitazone, compared to placebo, administered~     as monotherapy over 12 weeks in treatment naive patients with T2DM~   "
233080|NCT00505310|"~     The proposed study will assess the psychological and physiological benefits of an emotional~     expression intervention in patients with renal cancer. Patients will be randomly assigned to~     an emotional expression writing group or to a neutral writing group. This study will also~     evaluate the extent to which psychosocial factors mediate the intervention program and~     predict patients' recovery and adjustment to treatment. Potential mediators include level of~     cognitive processing, social networks/interactions, and sense of coherence and ability to~     find meaning in the illness experience.~      Specific objectives of the proposed research are:~        -  To evaluate an emotional expression intervention in patients with renal cancer.~          Researchers will determine the extent to which an emotional expression writing-based~          intervention enhances adjustment during the first 12 months following diagnosis and~          treatment. Dimensions of adjustment will be assessed by examining indices of QOL, mental~          health, and stress (subjective symptoms of distress, perceived stress, and mood).~        -  To determine the effects of an emotional expression writing-based intervention on immune~          function. The immune measures assessed in this study will include both general and~          autologous tumor-specific immune responses including cytotoxicity to K562 target cells;~          cytotoxicity to autologous tumor target cells; and functional assessment of type-1 and~          type-2 cytokines using autologous tumor and polyclonal stimulants.~        -  To identify the psychosocial processes underlying the efficacy of the intervention.~   "
233081|NCT00505297|"~     In order to design future disease modifying osteoarthritis drug (DMOAD) proof of concept~     studies, this study is being conducted to assess magnetic resonance imaging (MRI)~     measurements of cartilage morphology and glycosaminoglycan (GAG) content as it relates to the~     progression of disease in subjects with potentially rapidly progressing OA. The subject~     population is selected to have higher likelihood of having rapidly progressing OA (i.e., a~     more rapid joint space narrowing (JSN) compared to general knee OA population and thus, may~     be more likely to have changes in GAG content and/or cartilage volume. The results of this~     study may provide a reasonable means to assess DMOAD activity of drugs in development. The~     non-OA controls are included to determine the rate of change for subjects of similar age.~     Ideally, results of this study will identify reliable methods for delayed Gadolinium Enhanced~     MRI of cartilage (dGEMRIC) and MRI cartilage assessment that correlate with OA disease~     progression as compared to x-ray changes.~   "
233082|NCT00505284|"~     The purpose of this study is to determine the efficacy and safety of Perampanel in patients~     with painful diabetic neuropathy.~   "
233083|NCT00505271|"~     The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to~     determine the optimal dosing regimen for Rexin-G that would document the significant clinical~     benefits required to support a Phase II registration protocol for recurrent or metastatic~     breast cancer.~   "
233084|NCT00505258|"~     The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a~     comparator in hospitalized patients with bacteremia.~   "
233085|NCT00505245|"~     The purpose of this study is to try to learn more about common symptoms that may occur in~     patients due to cancer and its treatment. We also want to learn more about the impact of~     symptoms on your quality of life. Another goal is to learn how to better measure symptoms~     systematically when caring for patients.~      This is an investigational study. Up to 5,500 participants will participate in this~     multicenter study. Up to 5,000 will be enrolled at MD Anderson.~   "
233086|NCT00505232|"~     Mantle Cell Lymphoma (MCL) is a malignancy with a poor response to treatment and with a~     median survival of 2- 4 years since diagnosis. Although histology is similar to that of an~     indolent lymphoma, MCL is currently considered an aggressive tumour. Few prospective~     therapeutic trials have been reported in MCL, and results are difficult to interpret due to~     treatment heterogeneity. It is known that standard chemotherapy for other clinically~     aggressive lymphomas yields poor results. Recently, better results have been communicated~     with intense induction chemotherapy treatments or consolidating the response with high dose~     chemotherapy with stem cell support. Keeping in mind these considerations, we will use and~     intensive induction treatment with Hyper-CVAD/MTX-AraC associated with anti-CD20 in order to~     increase the overall response rate followed by consolidation treatment with Ibritumomab~     -tiuxetan (Zevalin) with the aim of eradicate the minimal residual disease, responsible of~     relapse.~   "
233087|NCT00505219|"~     The purpose of this study is to determine if Ixmyelocel-T grafting with demineralized bone~     matrix bound in autologous plasma after core decompression surgery is superior to core~     decompression with demineralized bone matrix bound in autologous plasma in preventing~     progression of osteonecrosis to a more severe disease stage (Stage II to III or higher) from~     the time of surgery until 24 months later, in patients with University of Pennsylvania~     (UPenn) Stage IIB or C disease at diagnosis.~   "
233088|NCT00505180|"~     The purpose of this study is to prospectively identify blood markers that identify chronic~     hemodialysis patients at risk for early (<90 days) and late (>= 1 year) mortality~   "
233089|NCT00505167|"~     It is well known that in the brain of the patients with Alzheimer's disease there is a~     glutamatergic hyperstimulation leading to neuronal death. Memantine is a low affinity~     antagonist of NMDA glutamate receptors. The use of this drug in the early phases of the~     disease could provide neuroprotective effects and delay of progression. The effects of~     memantine should be compared to those of donepezil, which is the most prescribed~     anticholinesterase drug.~   "
233090|NCT00505154|"~     The purpose of this study is to examine the the effect of the HMG-CoA reductase inhibitor~     Rosuvastatin on left ventricular remodeling in patients with dilated cardiomyopathy.~   "
233103|NCT00504985|"~     1. To describe fatigue severity and its related symptom clusters in cancer patients who are~          seeking emergency care for fever, pain, shortness of breath, or cancer therapy-related~          gastrointestinal toxicities.~        2. To describe inflammatory cytokine profiles in cancer patients who are seeking emergency~          care for fever, pain, shortness of breath, or cancer therapy-related gastrointestinal~          toxicities.~        3. To determine the type of cytokines that are associated with fatigue severity in cancer~          patients, with or without cancer treatment, in the early phase of infection, as well as~          in patients with pain, shortness of breath, or cancer therapy-related gastrointestinal~          toxicities.~   "
233484|NCT00499941|"~     The Alpha-1 Foundation Research Registry is a confidential database made up of individuals~     diagnosed with severe alpha-1 antitrypsin deficiency (Alpha-1) or the carrier state.~   "
233091|NCT00505141|"~     The Environmental Protection Agency has recognized that organophosphorus pesticides require~     close regulation and continued monitoring for human health effects and some (e.g~     chlorpyrifos) have been phased-out from the consumer market due to the special risk that it~     posed for children. There is growing evidence in support of the association between pesticide~     exposure and childhood leukemia. Studies of pesticides and their association with childhood~     cancer have been limited by study designs, self-reporting and lack of biological~     measurements. While several large studies in California found little evidence of an~     association between agricultural pesticide use and childhood leukemia, these results are in~     contrast with the associations observed with household exposures to pesticides. The real~     association may depend on timing of exposure, type of pesticide, dose and pathway of~     exposure. Furthermore, some persons may be more susceptible to the effects of specific~     pesticides due to inherited mutations in their detoxification pathways.~      We are conducting a pilot study to test the hypothesis that environmental exposure to~     pesticides in pregnancy or during the neonatal period, together with genetic susceptibility~     may lead to childhood ALL or brain cancer. The study is a multicenter, case-control study,~     based on collaboration between clinical researchers and basic science research to evaluate~     the risk for childhood cancer in relation to measured levels of pesticides (and their~     metabolites) and genetic polymorphisms. Biomarkers will be used to examine the risks of~     chronic low-dose exposures, and to characterize relationships between specific pesticides,~     childhood cancer and genetic susceptibility.~      Hypothesis: Interaction between environmental factors (pesticides) and maternal or child~     genetic polymorphisms may lead to childhood cancer.~   "
233092|NCT00505128|"~     Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis:~     a prospective multicenter randomized controlled study.~   "
233093|NCT00505115|"~     The aim of this study is to identify the protein secretion and consumption profile of the~     human blastocyst (secretome) and the implanted blastocyst (implantome) using the protein~     array technology.~   "
233094|NCT00505102|"~     The purpose of this study is to verify whether the reduction of cyclosporine dosages~     associated with Everolimus administration may improve renal function as compared to patients~     maintained on standard immunosuppressive therapy~   "
233095|NCT00505089|"~     This study will investigate the pharmacokinetic (PK) / total IL-1beta pharmacodynamic (PD)~     relationship in joint fluids of patients with rheumatoid arthritis (RA) treated with~     different doses of ACZ885 and to evaluate the impact of the subcutaneous (s.c.) versus~     intravenous (i.v.) route of administration.~   "
233096|NCT00505076|"~     Patients with schizophrenia are characterized by a broad range of neurocognitive~     abnormalities. These include impairments in attention, including abnormalities in sensory~     gating; executive function; visual and verbal learning and memory; working memory; processing~     speed; and social cognition (Nuechterlein et al, 2004). These impairments are major~     determinants of poor functional outcome in patients with schizophrenia (Green, 1996; Green et~     al, 2004). Conventional antipsychotics have limited effects on these impairments. Second~     generation antipsychotics may have modest benefits for cognitive function, but whether this~     represents a direct cognitive enhancing effect has not been established. Regardless, patients~     continue to exhibit pronounced cognitive impairments despite adequate second generation~     antipsychotic treatment. Adjunctive pharmacotherapy may offer a viable approach for the~     treatment of cognitive impairments. Adjunctive agents can be used to modulate specific~     neurotransmitter systems that are hypothesized to be involved in the pharmacology of~     cognitive functions.~      The standard of care for schizophrenia is antipsychotic medications to treat psychotic~     symptoms. However, cognitive impairments remain and these impairments have been found to be~     significantly associated with the poor psychosocial function observed in patients with~     schizophrenia. There is a considerable preclinical rationale for the use of drugs that act at~     the Gamma-amino-buyric acid (GABA) α2 subunit as adjunctive treatments to target cognitive~     impairments. MK-0777 GEM (Merck-0777 Gel Extrusion Module) formulation provides an~     opportunity to directly test this mechanism.~      The purpose of the proposed study is to examine the efficacy and safety of two doses of MK~     (Merck) -0777 GEM, 3 mg BID (twice daily) and 8 mg BID (twice daily), in the treatment of~     cognitive impairments in patients with schizophrenia. Secondary goals are to determine~     whether MK-0777 has beneficial effects on measures of functional capacity and patient~     self-report of cognitive function.~   "
233097|NCT00505063|"~     This study will look at your body's response to the new immunizations. We want to see how~     well they will protect you. Immunization is the same as vaccination. Our goal is to protect~     you as much as we can. We do not want you to have the measles, mumps, or whooping cough. We~     are doing the study because there is no standard way to re-immunize people after cancer~     treatments.~   "
233098|NCT00505050|"~     Recent meta-analysis reported reduction in mortality and hospitalization of HF~     patients.However, important issues in DMP for HF remain to be resolved. DMP are not~     homogeneous concerning methodology and in general included only elderly patients; most were~     tested in high-risk HF patients discharged from hospital; quality of life results are~     controversial; few reports included long-term results; some protocols had limited enrollment~     of screened patients, and it was suggested that could be less effective when patients are~     already followed by HF specialist.Improved survival was associated with cardiologist care as~     well with multidisciplinary teams providing specialized follow-up.Whether both together could~     benefits HF is not well defined. Also, no studies reported the long-term effects of a cyclic~     repetitive reeducation program.We tested whether a DMP that consisted of a long-term~     repetitive education program associated with a telephone monitoring could benefit HF~     outpatients in usual ambulatory care already under care of cardiologist with experience in HF~   "
233099|NCT00505037|"~     To evaluate the superiority to placebo, dose-responsibility and safety.~   "
233100|NCT00505024|"~     To test the effectiveness of the interactive voice response telephone system with a~     triage/feedback component that incorporates timely symptom assessment, feedback to~     physicians, critical treatment guidelines for managing selected symptoms (distress, sleep~     disturbance, shortness of breath, constipation, and pain) in a cohort of cancer patients~     during the first month post-thoracic surgery.~      This interactive voice response system (IVR) will be evaluated in a randomized clinical trial~     with an intervention group (IVR symptom assessment with triage) and a control group (IVR~     symptom assessment only).~      We hypotheses that:~        1. Patients in the MDASI-IVR plus triage group will have less symptom burden (less symptom~          severity, less symptom related interference, and better satisfaction of symptom control,~          better physical and emotional well-being) over the month of the trial compared to the~          control group.~        2. Patients in the MDASI-IVR plus triage group will have more frequent documentation of~          symptom management in line with treatment guidelines compared to the control group.~   "
233101|NCT00505011|"~     Cigarette smoking is a well-recognized risk factor of Graves’ disease and, particularly,~     Graves’ ophthalmopathy. Hence, germline polymorphisms of detoxification genes and genes~     belonging to the major DNA repair/apoptosis pathways might have an important role in disease~     susceptibility. In addition, as some of these genes are regulated by thyroid hormones, they~     could affect the outcome of these patients. Our objective was to assess the influence of the~     GST, CYP and TP53 gene polymorphisms in the risk of Graves' disease and its outcome.~   "
233102|NCT00504998|"~     The goal of the adaptive trial design is to determine the over-all safety of escalating doses~     of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the~     significant clinical benefits required to support a Phase II registration protocol.~   "
233104|NCT00504972|"~     Previous experience with antibody therapy in both NHL and CLL warrants further exploration of~     new antibody treatments for these diseases.~      Immunomedics has developed hLL1 (previously designated EPB-1), which is a CDR-grafted, fully~     humanized monoclonal antibody specifically targeting CD74.38 The human IgG1 backbone for hLL1~     is the same as hLL2 (epratuzumab), a monoclonal antibody whose safety has been demonstrated~     in clinical trials of patients with B-cell malignancies and autoimmune disorders.~      This is a Phase I, open-label, study conducted in patients with recurrent non-Hodgkin's~     lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who have progressed after at least one~     prior standard treatment. All patients will receive hLL1 administered intravenously once~     daily Monday through Friday of each of 2 consecutive weeks (10 total doses.) Patients will be~     assigned to a cohort for hLL1 treatment dose assignment (escalating doses of hLL1 per~     statistical plan) in order to determine the maximum tolerated dose (MTD) for this~     administration schedule.~   "
233105|NCT00504959|"~     This extension study will investigate the long-term safety and tolerability of multiple~     intravitreal injections of ranibizumab administered to patients with subfoveal choroidal~     neovascularization secondary to age-related macular degeneration who have been previously~     treated in either of the two ongoing ranibizumab studies CRFB002A2302 (EXCITE) or~     CRFB002A2303 (SUSTAIN~   "
233106|NCT00504946|"~     There is mounting evidence that successful allergen immunotherapy (SIT) functions through the~     induction of different subset of Treg including Foxp3 positive cells, therefore additional~     strategies to enhance this property are highly attractive. Based on previous findings we~     assumed that combine allergen immunotherapy with non-specific treatments such as~     glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced~     allergen tolerance induction and improved clinical effectiveness of allergen-specific~     immunotherapy~   "
233107|NCT00504933|"~     The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg,~     compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.~   "
233108|NCT00504920|"~     Primary Objective:~      1. To assess the self-reported symptoms and the plasma cytokine levels of AML/MDS patients~     pretransplantation and posttransplantation with allogeneic blood and marrow in order to~     identify changes in symptoms (or symptom clusters) and changes in cytokines that may be~     related to the conditioning regimen and/or to the development of GVHD during the 100 days~     posttransplant.~      Based on the current literature, both animal and human research, in this study we hypothesize~     that increases in TNF alpha to be associated with poor appetite, sleep disturbance and~     fatigue, but not with increases in pain, depression and numbness.~   "
233109|NCT00504907|"~     This is a placebo-controlled, double-blind, randomised, single dose escalation Phase I~     clinical trial to determine the safety and tolerability of BTA9881 administered orally to~     healthy subjects~   "
233110|NCT00504894|"~     This study involves 90 healthy volunteers aged between 18 and 50 recruited from the general~     community. It involves doing a set of simple memory tests while inside a fMRI machine. The~     subject is given a very low dose of an anesthetic drug intravenously while in the scanner.~     The subject then sees a sequence of pictures on a screen, and presses a button if they~     remember seeing the picture before. While this is happening, the scanner will be capturing~     images that tell us what parts of the brain are active. Hypothesis: patterns of hippocampal~     and amygdala activation during the encoding and retrieval of memory,as measured by fMRI, will~     be altered by intravenous anesthetics such that suppression of hippocampal and amygdala~     activities will be dissociable. This dissociation pattern will be different between the drugs~     propofol and thiopental.~   "
233111|NCT00504881|"~     This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo~     in subjects suffering from Epilepsy.~   "
233112|NCT00504855|"~     The purpose of this study is to compare waterproof cast padding material to standard~     cotton/poly-cotton cast padding material to the presence or absence of cast sores of the~     heel.~   "
233113|NCT00504842|"~     This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate~     the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and~     ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in~     subjects with acute ischemic stroke.~   "
233114|NCT00504829|"~     The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a~     combination of atorvastatin and fenofibrate.~   "
233115|NCT00504816|"~     The purpose of this research study is to demonstrate a lack of effect of multiple doses of~     GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the~     effects of GSK189075 on hormonal levels and on birth control.~   "
233116|NCT00504803|"~     Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host~     Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative~     Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study~   "
233117|NCT00504790|"~     This is a Phase I, open-label, first time in human study of GSK923295, in adult subjects with~     cancers that do not respond to standard therapy. This study will be conducted in two stages;~     a dose-escalation stage (Stage 1) and an expansion cohort stage (Stage 2).~   "
233118|NCT00504777|"~     This single arm study will assess the safety and efficacy of MabThera in combination with~     methotrexate in patients with rheumatoid arthritis who have had an inadequate response or~     intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on~     days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with~     methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study~     treatment is 3-12 months, and the target sample size is <100 individuals.~   "
233157|NCT00504257|"~     The purpose of this study is to evaluate the effectiveness of the combination of Avastin and~     Docetaxel in the treatment of women with platinum sensitive recurrent epithelial ovarian~     cancer within 12 months of platinum chemotherapy.~   "
233158|NCT00504244|"~     This study is designed to explore the use of myfortic ® in patients with active lupus~     erythematosus. Similar drugs in this class are increasingly used in organ transplantation and~     in autoimmune diseases. With the established safety profile of myfortic ® in~     allo-transplantation and the already existing data of mycophenolate mofetil in autoimmune~     diseases, this study should help to demonstrate the beneficial effect of myfortic ® on lupus~     activity. The aim of the study will be to show a decreased disease activity with myfortic ®~     compared to standard maintenance therapy with azathioprine.~   "
233119|NCT00504764|"~     Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB~     M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and~     RARa/PML). Thereby it can be separated from all other forms of acute leukemia.~      By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be~     reached. On average, about 10% of patients still die in the early phase of the treatment and~     about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by~     qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the~     individual kinetics of MRD and to identify patients with an imminent hematological relapse.~      A standardized treatment for patients with relapsed APL has not yet been established. With~     arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting~     molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose~     dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower~     concentrations. ATO was also successfully administered before allogeneic and autologous~     transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe~     and in the USA.~      After remission induction, there are several options for postremission therapy Previous~     studies shows that risk of relapse is higher in patients treated with ATO postremission in~     monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH).~     Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in~     posterior response to transplantation. It is due to a low toxicity or a best quality of~     remission to TPH. It seems better, for these reasons, the intensification with TPH~     (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand,~     patients no candidates to TPH can be treated with ATO combined with other active agents in~     APL, as ATRA, anthracyclines o Mylotarg~   "
233120|NCT00504751|"~     Objectives~      The primary objective of this study is to:~      • determine the complete and partial response rates and the toxicity profile of bortezomib~     (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus~     rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell~     non-Hodgkin's lymphoma~      The secondary objectives of this study are to:~        -  assess event free survival and overall survival~        -  assess conversion of chemo-resistant to chemo-sensitive disease~        -  assess the ability to collect stem cells from patients treated with salvage VIPER who~          then undergo autologous stem cell transplantation~        -  perform correlative studies on pre-treatment tumor biopsy specimens; analyses will~          include the assessment of immunohistochemical expression patterns (germinal center B~          cell vs. activated B cell) and NF-κB activity~   "
233121|NCT00504738|"~     The purpose of this protocol is to obtain biologic samples from the blood and lungs from~     patients with lung diseases in order to study the causes and indications of these disorders,~     learn how these lung disease manifest and progress, and how the lung disease can be treated.~   "
233122|NCT00504725|"~     The primary aim of the study is to demonstrate a reduction in circulating interleukin 6~     levels at 4 and 24 hours after completion of lobectomy (either VATS or open). The null~     hypothesis (H0) is thus that there is no difference in circulating interleukin 6 levels when~     patients are given either ketamine or placebo (0.9% saline in equivalent volume). The~     alternative (two tailed) hypothesis (HA) if the null is disproved is that ketamine leads to~     significantly different levels of interleukin 6 at 4 and 24 hours after completion of~     surgery. We plan to randomize 40 patients to receive either ketamine or placebo, in a block~     of 4 randomization design stratified by whether surgery is performed by VATS or open~     lobectomy.~   "
233123|NCT00504712|"~     There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels~     in men. Testosterone treatment has shown beneficial effects on blood sugar control and~     obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen~     on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels).~     Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that~     testosterone will have beneficial effects on peripheral vascualr disease in men with low~     serum testosterone and type 2 diabetes.~   "
233124|NCT00504699|"~     Breast cancer patients are commonly treated with drugs that eggs present in the ovary and may~     reduce their chance for getting pregnant. Their fertility can be preserved by stimulating~     their ovaries, collecting multiple eggs, fertilize them in the lab and freeze them. Ovarian~     stimulation increase their estrogen levels in blood.this may stimulate their cancer and~     increase chance for recurrence. If a medicine that prevent estrogen rise is used (letrozole),~     this may increase the safety of stimulation. In this study we compared ovarian stimulation in~     breast cancer patients using letrozole with those who did not undergo stimulation and showed~     that there is no increase risk for recurrence after a median follow up of 2 years~   "
233125|NCT00504686|"~     Recently a clinical prediction rule (CPR) has been developed that identifies patients with~     neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust~     manipulation and an active range of motion exercise. Although the initial predictor variables~     identified during the development of a thoracic spine manipulation CPR seem to have adequate~     face validity, there is no guarantee that these factors will persist in a different group of~     patients, even ones with similar characteristics as those used in the initial exploratory~     study. The purpose of this follow-up study in which patients will be randomly assigned to~     receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic~     exercise alone will be to investigate the validity of the previously developed CPR. If the~     CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine~     thrust manipulation should experience improved outcomes compared to patients who are negative~     on the CPR and receive thoracic spine manipulation, and compared to patients who are positive~     on the CPR but receive the intervention believed to be effective for another subgroup of~     patients with neck pain.~   "
233126|NCT00504673|"~     This trial is conducted in Europe. The purpose of the trial is to investigate the effect of~     insulin detemir on weight change in overweight and obese patients with type 2 diabetes.~   "
233127|NCT00504660|"~     The goal of this clinical research study is to learn if the combination of 6-Thioguanine,~     Xeloda (capecitabine), and Celebrex (celecoxib) with Temodar (temozolomide) or Lomustine~     (CCNU) is effective in the treatment of recurrent or progressive anaplastic glioma or~     glioblastoma multiforme in patients who have failed previous treatments. The safety of these~     combination treatment will also be studied.~      Objectives:~      1.1 To determine the efficacy, as measured by 12 month progression-free survival, of~     TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in the~     treatment of patients with recurrent and/or progressive anaplastic gliomas or glioblastoma~     multiforme.~      1.2 To determine the long-term toxicity of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed~     by CAPECITABINE and CELECOXIB in recurrent anaplastic glioma or glioblastoma multiforme~     patients treated in this manner.~      1.3 To determine the clinical relevance of genetic subtyping tumors as a predictor of~     response to this chemotherapy and long term survival~   "
233128|NCT00504647|"~     Hypertrophic Cardiomyopathy is an inherited condition characterized by thickening~     (hypertrophy) of the heart muscle. Many patients who have this condition have a reduced~     ability to exercise because of breatlessness, which can in some cases be severe. This appears~     in most cases to be due to an impairment of the filling of the heart, especially on exercise~     this limits the amount of blood the heart is able to pump. Several factors may contribute to~     this slow filling of the heart, including (1) The heart contracts and relaxes in an~     incoordinate way (called 'dyssynchrony') which is inefficient, and (2) The filling of the~     main pumping chamber (the left ventricle) may be impeded by high pressure in the other~     ventricle(the right ventricle)- in other words the left ventricle is 'squashed' by the right~     ventricle. This is known as diastolic ventricular interaction.~      Although drugs can improve the filling of the heart and relieve symptoms, some patients~     remain very symptomatic despite these drugs.~      The mechanisms responsible for the filling abnormality in patients with Hypertrophic~     Cardiomyopathy are similar to those seen in the much more common condition known as Heart~     Failure. A special type of pacemaker technique called 'Biventricular Pacing' has been shown~     to markedly improve symtoms in patients with heart failure. This form of pacing has been~     shown to improve both 'dyssynchrony' ( incoordination) and 'ventricular interaction'~     (squashed left heart) in patients with Heart Failure.~      We propose that Biventricular pacing may similarly improve these abnormalities in patients~     with Hypertrophic Cardiomyopathy, resulting in an improvement of symptoms. The study will~     focus on patients with the condition who have severe symtoms despite being on optimal~     currently available drug therapy.~   "
233129|NCT00504634|"~     Primary Objective:~      1. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for~     patients with multiple myeloma.~      Secondary Objective~      1. To determine the toxicity profile of bortezomib in patients with multiple myeloma~     undergoing allogeneic progenitor cell transplantation.~   "
233130|NCT00504621|"~     A number of studies have shown that the quality of life of two common interstitial lung~     diseases (ild), sarcoidosis and pulmonary fibrosis patients, is impaired and that fatigue is~     a substantial problem for those patients. Furthermore, breathlessness is an additional major~     problem in pulmonary fibrosis. In the field of cardiovascular disease and breast cancer,~     personality factors have shown to play a role in patient's morbidity, mortality, quality of~     life, fatigue, depressive symptoms, and one study showed a predictive role of personality~     factors in health care consumption. No studies examining personality factors have been~     performed in sarcoidosis or pulmonary fibrosis. Therefore, the aim of the present study is to~     examine the role of personality factors as predictors of fatigue, quality of life, prognosis,~     and health care consumption in sarcoidosis and pulmonary fibrosis. In this study a number of~     possible moderators, such as social support, will also be examined, aiming to get a full~     picture of the relationship between the various factors examined. Known and new sarcoidosis~     and pulmonary fibrosis patients (inclusion period 1 year) of ild care team of the outpatient~     clinic of the department of Respiratory Medicine of the University Hospital Maastricht will~     be asked to participate through completing questionnaires at baseline and every six months~     for 18 months, and allowing the researchers access to their medical records for the purpose~     of this study.~   "
233131|NCT00504608|"~     The primary objective of the study was to provide further clinical and statistical evidence~     of the efficacy of r-hLIF, in comparison with placebo, administered during the luteal phase~     after IVF and ET for improving embryo implantation in infertile women with a history of at~     least 2 implantation failures following transfer of fresh embryos. The secondary objective of~     the study was to assess the safety profile of r-hLIF in the proposed indication.~   "
233132|NCT00504595|"~     This study was intended to assess the safety, efficacy, and response to treatment using the~     American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to~     investigate a potential biomarker profile in adult patients with established rheumatoid~     arthritis~   "
233133|NCT00504582|"~     Primary Objective:~        -  To determine whether the use of a fibrin sealant applied to axillary soft tissues~          following node dissection can result in earlier drain removal.~      Secondary Objectives:~        -  To determine the postoperative morbidity rate using fibrin sealant following axillary~          node dissection.~        -  To assess patient-valuation of outcome by performing a cost-benefit analysis using a~          willingness-to-pay model.~        -  To determine if serum levels, lymphatic fluids level, or cutaneous expression of~          vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C~          (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3)~          correlates with nodal tumor burden or development of lymphedema in patients with~          melanoma.~   "
233134|NCT00504556|"~     This study is to assess the safety of a potential new drug DU-176b for the prevention of~     stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation~     (AF). The duration is 3 months of treatment and a 30 day follow-up visit.~   "
233135|NCT00504543|"~     This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free~     (calcineurin inhibitor) regimen in renal transplant recipients.~   "
233136|NCT00504530|"~     This study was designed to obtain pilot clinical evidence of the efficacy, safety and~     acceptability of r-hLIF administered during the luteal phase after IVF/intra-cytoplasmic~     sperm injection (ICSI) and ET for improving embryo implantation in infertile women with a~     history of at least three implantation failures following ART. Based on LIF expression~     patterns and experimental data from animal research a role of LIF in embryo implantation is~     anticipated.~   "
233137|NCT00504517|"~     We would like to better understand how different educational strategies may influence the~     practice of family medicine. More specifically, we are interested in participant satisfaction~     with the educational program, participant retainment in this career, and to see if the~     curricular change better prepares participants for contemporary clinical practice.~   "
233138|NCT00504504|"~     Primary Objective:~      - To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD~     combination chemotherapy.~      ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.~   "
233202|NCT00503672|"~     We would like to quantify the amount and type of activity a typical pregnant woman engages in~     and then compare the pregnancy outcomes of women with varying activity levels. To do this, we~     will have women wear a device known as an accelerometer (that records activity by measuring~     changes in voltage levels) at certain times in their pregnancies.~   "
233139|NCT00504491|"~     Since there is no standard rescue therapy for refractory CLL or relapsed to the purine~     analogous, our target is to carry out a rescue therapy combining several chemotherapy agents~     (CHOP) adding the synergistic effect of Rituximab in order to act against tumour-like CLL~     forms, with assessable size lymph nodes. Afterwards, based in other studies, we shall study~     the role of Alemtuzumab as drug for consolidation or improvement of responses obtained with~     the initial therapy (CHOP-R), acting by cleaning from peripheral blood and bone marrow the~     CLL lymphocytes that may have had remain as residual after chemotherapy induction therapy.~     More precisely, the addition of Alemtuzumab as maintenance treatment would increase the~     complete responses with negative residual disease number and may prolong the duration of the~     response. For this, it is necessary to have not only an adequate and rigorous clinical~     follow-up but also biological, i.e. being able to analyze minimal residual disease by~     molecular biology techniques. This is the reason of writing this phase II clinical trial~     protocol.~   "
233140|NCT00504478|"~     The purpose of this study is to examine the anti inflammatory effect of high complex~     carbohydrate diet, supplemented by omega-3 fatty acids.~   "
233141|NCT00504465|"~     To compare sequential dinoprostone and oxytocin for induction of labor at term with intact~     membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings~     from smaller trials and add to data on fetal safety.~   "
233142|NCT00504452|"~     The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given~     every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral~     regimens.~   "
233143|NCT00504439|"~     To assess safety of SB-656933 following repeat dosing for 14 days.~   "
233144|NCT00504426|"~     The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily~     inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to~     osteoporosis.~   "
233145|NCT00504413|"~     The purpose of this study is to determine to what extent CYP2B6, CYP3A4, and MDR1~     polymorphisms affect the metabolism of methadone.~   "
233146|NCT00504400|"~     The purpose of this study is to investigate if a new drug called ranibizumab is effective to~     treat a rare bilateral disease of the macula: type 2 idiopathic macular telangiectasia (type~     2 IMT). 10 patients will receive monthly injections of the drug into one eye over a period of~     one year.~   "
233147|NCT00504387|"~     Oral burning can have a multitude of reasons. Recent neurophysiologic study results suggest~     that a primary burning mouth disorder (BMD) may be a peripheral and/or a central neuropathic~     disorder. The aim of this study is to first identify patients with a primary burning mouth~     disorder by excluding other possible causes for oral burning. By means of qualitative and~     quantitative sensory testing and a gustatory examination in the individual patient the~     investigators want to find out whether neurosensory differences exist between patients with a~     primary BMD and controls and whether gustatory and neurosensory deficits always coexist in~     BMD-patients.~   "
233148|NCT00504374|"~     Primary Objectives:~        -  Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned~          for treatment and collect information on symptoms and symptom treatments at baseline and~          on follow-up.~        -  Develop preliminary statistical models incorporating genetic data (which will be~          obtained from an existing protocol, CPN 91-001, Margaret Spitz), disease-related~          variables (e.g., stage of disease, location of tumor), clinical health status (e.g.,~          performance status, comorbid conditions), and sociodemographic characteristics (e.g.,~          age, sex, race) for predicting the risk of severe and persistent symptoms.~      Analytical aim: To determine if symptoms (e.g., fatigue, depression, lack of appetite) will~     differ in severity by IL-6 gene polymorphisms (-174G/C, -597G/A, -572G/C, -373An/Tn).~      This study (NIH-CA109043, Reyes-Gibby, 2004-2009) builds upon an NIH-funded (NIH-CA55769,~     Spitz, 2003-2008) study of the molecular epidemiology of lung cancer.~   "
233149|NCT00504361|"~     This is a research study where researchers are collecting blood to evaluate the genetic~     characteristics of individuals with chronic lung diseases, including asthma, COPD (chronic~     obstructive pulmonary disease), interstitial lung disease, cystic fibrosis, and lung cancer.~     The investigators hope to be able to identify an association between a genetic make-up in the~     blood samples and the risks of developing a particular lung disease, or severity of a lung~     disease. The findings of this study might be important to develop future preventative methods~     and potential treatments for the management of lung disease.~   "
233150|NCT00504348|"~     The purpose of the study is to evaluate the efficacy and safety of the combination treatment~     of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial~     pneumonitis with comparison against corticosteroid-treated historical controls.~   "
233151|NCT00504335|"~     This trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when~     administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for~     use starting at 500 mg.~   "
233152|NCT00504322|"~     This study is a randomized, double-blinded assessment of biologic efficacy of AdcuCD40L. The~     individuals enrolled in this study will be individuals with biopsy proven resectable~     esophageal carcinoma. The dose of the AdcuCD40L vector (administered endoscopically directly~     to the tumor) will be the highest tolerable dose (most likely 10^11 particle units)~     determined from Weill-IRB protocol #0011004683 dose escalation study.~   "
233153|NCT00504309|"~     The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of~     an omega-3 fatty acid concentrate in a group of people who normally are not treated for high~     lipids.~   "
233154|NCT00504296|"~     RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of SB939 in treating~     patients with locally advanced or metastatic solid tumors.~   "
233155|NCT00504283|"~     An analgesia protocol for acute renal colic will lead to faster significant reductions in~     pain than prior practice.~   "
233156|NCT00504270|"~     This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients~     with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3~     treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or~     c)placebo. The anticipated time on study treatment is <3 months, and the target sample size~     is <100 individuals.~   "
233160|NCT00504218|"~     This study will determine the prevalence of endocrine-related side effects in children who~     have been treated for cancer and establish a database and registry organized according to~     cancer diagnosis, treatments and endocrine side effects. In children, the endocrine system,~     which includes glands and hormones that help to control metabolism, growth, development and~     reproduction, is particularly vulnerable to long-term side effects associated with cancer and~     its treatments. The study will also serve to help train medical fellows, residents and~     students in identifying and managing endocrine abnormalities in children who have been~     diagnosed with and treated for cancer.~      Children between 2 and 24 years of age who have been treated for a childhood cancer and have~     been disease-free for at least 1 year may be eligible for this study.~      All participants undergo the following procedures:~        -  Review of cancer treatment record~        -  Review of medical and family history~        -  Blood draw for DNA studies~        -  Physical examination and body measurements (height, weight, waist, body proportions)~        -  Completion of child health questionnaires~        -  Individualized screening and counseling program~        -  Review of the following endocrine systems: growth, pituitary and hypothalamic function,~          thyroid function, ovary and testicular function, bone health, risk of obesity and~          diabetes~      The following additional studies may be done, as clinically indicated:~        -  Magnetic resonance imaging (MRI) of the brain~        -  Thyroid, testicular or ovarian ultrasound~        -  DEXA scan to measure bone density~        -  Wrist x-ray to measure bone age~        -  Blood tests~        -  Urine pregnancy test for girls who are old enough to have menstrual periods~        -  Stimulation testing (tests that involve giving medicine by mouth or in the vein and then~          measuring blood levels of substances afterwards, such as oral glucose tolerance test,~          arginine-clonidine growth hormone stimulation test, ACTH stimulation test, and~          gonadotropin-releasing hormone stimulation test)~      Children with endocrine abnormalities are offered standard treatments.~   "
233161|NCT00504205|"~     RATIONALE: MP470 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This clinical trial is studying the side effects and best dose of MP470 in treating~     patients with unresectable or metastatic refractory solid tumor, Hodgkin's lymphoma, or~     non-Hodgkin's lymphoma.~   "
233162|NCT00504192|"~     The role of systemic chemotherapy in advanced biliary tract cancer (BTC) is known to be very~     limited although various single-agent or combination therapies had been tested. However,~     there is a possibility that palliative chemotherapy induce prolong survival and improve~     quality of life in advanced BTC based on several studies. A GERCOR study showed the promising~     result of gemcitabine in combination with oxaliplatin as first line chemotherapy in advanced~     BTC. Therefore, this phase II trial was planned to investigate efficacy and toxicity of~     combination chemotherapy with gemcitabine and dose adjusted oxaliplatin in patients with~     inoperable BTC in Korea.~   "
233163|NCT00504179|"~     The purpose of the study was to determine the effect on recovery after surgery of patients~     who received a standardized daily protocol of osteopathic manipulative treatment.Patients~     undergoing elective coronary artery bypass surgery were voluntarily enrolled in the study and~     assigned to one of three groups.One group received a standardized daily treatment protocol~     along with conventional care, another received daily similar placebo treatment with~     conventional care, and a final group received only conventional post surgical care.The~     research hypothesis was that daily treatment with osteopathic manipulative treatment would~     reduce hospital stay and hasten recovery from surgery.Persons in the treatment group had~     earlier discharge, and faster recovery of bowel function and basic mobility.~   "
233164|NCT00504166|"~     The purpose of this study is to evaluate the changes in bone structure as determined by~     magnetic resonance imaging measurements among early postmenopausal women after 24 months of~     treatment with alendronate, 70 mg once a week as compared to placebo~   "
233165|NCT00504153|"~     This phase II trial is studying dasatinib to see how well it works in treating patients with~     previously treated metastatic colorectal cancer. Dasatinib may stop the growth of tumor cells~     by blocking some of the enzymes needed for their growth.~   "
233166|NCT00504140|"~     Primary Objectives:~        1. To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the~          treatment of relapsed osteosarcoma.~        2. To determine if IFN alters the plasma pharmacokinetics of etoposide.~        3. To determine the toxicities of IFN and etoposide when administered together.~        4. To determine IFN blood levels following combination therapy.~   "
233167|NCT00504127|"~     To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of~     signs and symptoms of osteoarthritis~   "
233168|NCT00504114|"~     The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to~     examine the knee and the bony and soft tissue changes so as to better predict the progression~     of osteoarthritis and acute knee injuries.~   "
233169|NCT00504101|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as arsenic trioxide and melphalan,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving high-dose combination chemotherapy together with~     bortezomib may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with arsenic trioxide and melphalan in treating patients undergoing an~     autologous stem cell transplant for multiple myeloma.~   "
233170|NCT00504088|"~     To compare the outcome of bypass surgery and plaque excision for treatment of critical limb~     ischemia in the lower limbs~   "
233171|NCT00504075|"~     To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a~     threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the~     safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects~     with chronic ITP for.~   "
233172|NCT00504062|"~     To investigate the effect and safety of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose~     twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years~     old in need for inhaled glucocorticosteroid treatment. To compare the efficacy of budesonide~     Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks to that of fluticasone~     Diskus® 50 μg/dose and 100 μg/dose twice daily for 6 week.~   "
233185|NCT00503893|"~     The goal of this clinical research study is to collect information and blood samples to try~     to learn why some people develop cancers and tumors, why some families have more cancers than~     others, and whether certain genes or regions of DNA (the genetic material of cells) affect a~     person's risk of getting cancer.~      This is an investigational study.~      Up to 1500 patients and family members will take part in this study. All will be enrolled at~     MD Anderson.~   "
233203|NCT00503659|"~     This study is meant to compare two routine diagnostic approaches in patients with bronchial~     asthma. Patients are challenged with methacholine in order to measure their bronchial~     response. We compare the evaluation of the effects of incremental concentrations versus~     incremental dosages.~   "
247513|NCT00313248|"~     The purpose of this study is to evaluate whether treatment with a new drug called~     ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop~     tumor growth.~   "
233173|NCT00504049|"~     Several methods exist to evaluate motor function in the child with cerebral palsy and are~     used to assess the outcome of a clinical intervention. However, these scales are not directed~     towards measuring the changes in muscle activity patterns that can result from the~     intervention. For example, there are classification scales aimed at measuring motor function~     and functional abilities, and indices of gait function. These scores, while providing a way~     to quantify function and mechanics, do not directly measure muscle activation~     characteristics. Therefore, these tests may be insensitive to how the intervention has~     directly affected muscle function, which is usually the focus of the intervention (i.e.~     botulinum toxin, functional electrical stimulation, dorsal rhizotomy). Muscle biopsies and~     motor evoked potentials can provide information about the muscle activation characteristics,~     however, they are invasive and there are concerns about using these techniques on the~     pediatric population and/or the practicality of clinical implementation, especially since~     they do not provide insight into how the muscle behaves during a functional task. One method~     that can be used to provide insight into muscle activity in a non-invasive and clinically~     meaningful manner is the use of surface electromyography (sEMG). Surface EMG is typically a~     routine part of clinical assessment and the evaluation of motor impairment in CP. However,~     the analysis of the data has been limited in most cases to examination of signal amplitude or~     differences in muscle onset and offset timing.~      The long-term goal of this research is to develop an analysis method for sEMG that can be~     used during functional tasks for treatment planning, diagnostic, assessment purposes in CP.~     This is to be accomplished through the use of the continuous wavelet transform (CWT). By~     developing an assessment method based on muscle activity, it is believed that a clinically~     viable measurement tool can be devised that will provide a level of insight into the effects~     of an intervention on muscle pathophysiology that is not currently available. The first step~     in progressing towards this long-term goal is to determine the variability and range of~     expected time-frequency patterns that can be expressed in a given population (i.e., cerebral~     palsy) during the execution of a meaningful task (gait), and relate the time-frequency~     information back to more standard assessments~   "
233174|NCT00504036|"~     To demonstrate, during a prospective randomized medico-economic study, in morbidly obese~     patients (BMI > 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to~     usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and~     peri-operative morbidity.~   "
233175|NCT00504023|"~     RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in~     different ways and stop tumor cells from growing. Applying topical imiquimod to the vulva may~     be an effective treatment for recurrent Paget's disease.~      PURPOSE: This clinical trial is studying how well topical imiquimod works in treating~     patients with recurrent Paget's disease of the vulva.~   "
233176|NCT00504010|"~     Arnica in a topical gel formulation will be compared to a placebo to determine whether it~     decreases muscle soreness following leg exercise when applied to the legs.~   "
233177|NCT00503997|"~     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving pemetrexed together with oxaliplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving pemetrexed together with oxaliplatin~     works in treating patients with locally advanced head and neck cancer.~   "
233178|NCT00503984|"~     Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth~     Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.~   "
233179|NCT00503971|"~     This is an open label, non-randomized, sequential, phase I/II trial in patients with stage~     IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations after progression to~     Erlotinib. The study will have two parts. The first part (phase I) will be a dose finding~     (MTD) study to be implemented at three hospitals. The second part of the study (phase II)~     will asses the safety and efficacy of the combination. In this second part (phase II)~     patients will be treated with oral Erlotinib 150 mg P.O daily plus oral Vorinostat~     administered according to the results of the phase I. The study endpoints to be evaluated~     will include safety and response rate (RR) as primary endpoints and clinical benefit rate~     (CBR), time to progression, time to response, response duration and progression free survival~     as secondary endpoints. All the patients (phase I and II) will be treated until progression~     disease, unacceptable toxicity or withdrawal of the consent, and will be treated at the~     discretion of the principal investigator.~   "
233180|NCT00503958|"~     RATIONALE: Environmental exposure and genetic predisposition may affect the risk of~     developing cancer later in life. Learning about genetic markers and the long-term effects of~     environmental exposure may help the study of lung cancer in the future.~      PURPOSE: This research study is looking at risk factors and genetic markers in healthy~     participants and in patients with lung cancer.~   "
233181|NCT00503945|"~     The aim of this study is to clarify the influence of obstructive sleep apnea syndrome on left~     ventricular function using echocardiographic parameters including the myocardial performance~     index (Tei-index), and to determine the short-term effects of nCPAP on them.~   "
233182|NCT00503932|"~     The primary objective of the Phase I portion of this study is to evaluate the safety of a~     combination of capecitabine and proton therapy for patients with locally advanced or~     recurrent rectal cancer. The maximum tolerated dose (MTD) will be determined in the Phase I~     portion of this trial.~      The primary objective of the Phase II portion of this study is to evaluate the local control~     rate in patients treated with the above regimen at the MTD.~      Secondary Objectives:~        1. To evaluate local tumor response in patients treated with the above regimen.~        2. To evaluate the relapse-free and overall survival in patients treated with the above~          regimen.~        3. To evaluate proton dosimetry in patients receiving this treatment.~        4. To evaluate quality of life in patients receiving this therapy.~   "
233183|NCT00503919|"~     The overall objective of this study is to identify potential improvements for a noninvasive~     method of diagnosing dysplasia and neoplasia in the cervix using Multi-spectral Digital~     Colposcopy (MDC), a device that uses fluorescence and reflectance spectroscopy to compare~     images to histopathologic mapping of the cervical epithelium.~      Primary Objective:~      -To measure Multi-spectral Digital Colposcopy images in vivo of the cervix both before and~     after acetic acid in a screening population.This is a second generation research device with~     low significant risk for which we are studying MDC.~      Secondary Objectives:~        1. To evaluate the effect of the fading of acetic acid in the image contrast obtained over~          time to see if this fading can predict the presence of any neoplasia.~        2. To evaluate mapping the cervix so that software can reconstruct the cervical epithelial~          map as evaluated by a Papanicolaou Smear to compare to routine colposcopic images as~          well as those from the Multi-spectral Digital Colposcopy (MDC).~   "
233184|NCT00503906|"~     The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will~     increase the progression-free survival (PFS) in patients with first line metastatic breast~     cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with~     definable metastatic disease, 6 or more months after primary treatment.~   "
233186|NCT00503880|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells~     found in bone marrow or in peripheral blood and may help the immune system recover from the~     side effects of chemotherapy. Giving clofarabine and cytarabine together with G-CSF may kill~     more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and~     to see how well it works when given together with cytarabine and G-CSF in treating patients~     with myelodysplastic syndromes.~   "
233187|NCT00503867|"~     The main purpose of this study is to determine the safety and toxicity of treatment with~     SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma~     (HCC). Other purposes of this study include assessment of the effect of treatment on overall~     survival, the length of time it takes for the disease to worsen, if and how the treatment~     affects the patient's quality of life, and if and how the cancer responds to the treatment.~   "
233188|NCT00503854|"~     Primary Objectives:~        -  To determine whether fatigue improves as patients are treated for febrile neutropenia~          (Day #1, Day #2 and Day #6).~      Secondary Objectives:~        -  To identify clinical factors associated in cancer patients with low risk for outpatient~          treatment of febrile neutropenia on either outpatient febrile neutropenia treatment~          pathway presenting with moderate to severe fatigue. Moderate fatigue is defined as a~          score of 4 through 6 on the Brief Fatigue Inventory and severe fatigue is defined as a~          score of 7 through 10 on the Brief Fatigue Inventory.~        -  To describe demographic information in cancer patients with low risk for outpatient~          treatment of febrile neutropenia and fatigue while enrolled in either of two outpatient~          febrile neutropenia treatment pathways.~   "
233189|NCT00503841|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This clinical trial is studying how well erlotinib works in treating women~     undergoing surgery for stage I, stage II, or stage III breast cancer.~   "
233190|NCT00503828|"~     Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast~     Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional~     medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the~     anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of~     osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate~     the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of~     patients with knee osteoarthritis.~   "
233191|NCT00503815|"~     This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA~     approved bowel preparation in adult subjects undergoing colonoscopy.~   "
233192|NCT00503802|"~     Obstructive sleep apnea occurs in 2-4% of middle age adults and results in significant~     morbidity and mortality. The first line therapy is provision of continuous positive airway~     pressure (CPAP) via a nasal mask chronically. Nasal resistance related to nasal turbinate~     enlargement may compromise CPAP treatment. This randomized double-blind~     sham-placebo-controlled trial tests the hypothesis that nasal turbinate reduction improves~     the nasal passage, CPAP use, and sleep apnea quality of life in newly diagnosed sleep apnea~     patients who are recommended CPAP therapy.~   "
233193|NCT00503789|"~     Infants will be fed infant formula and stool characteristics assessed.~   "
233194|NCT00503776|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by~     chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation~     therapy are more effective with or without amifostine in treating head and neck cancer.~      PURPOSE: This randomized phase II trial is studying amifostine to see how well it works~     compared with standard care in reducing side effects in patients undergoing chemotherapy and~     radiation therapy for stage III or stage IV head and neck cancer.~   "
233195|NCT00503763|"~     The aim of the study is to evaluate the effect of statin administration on the course of~     progressive Smoldering Multiple Myeloma.~   "
233196|NCT00503750|"~     This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor~     2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with~     trastuzumab before having breast surgery.~   "
233197|NCT00503737|"~     The American Cancer Society and The Centers for Disease Control and Prevention in~     collaboration with The National Colorectal Cancer Roundtable published How to Increase~     Colorectal Cancer Screening rates in Practice: A Primary Care Clinician's Evidence-Based~     Toolbox and Guide in 2005. This toolbox outlines evidence-based interventions aimed at~     increasing colorectal cancer screening by primary care providers and their office staff. The~     Toolbox contains the tools to design a multifaceted intervention to increase primary care~     physician rates of colorectal cancer screening (CRCS). This is a pilot study to look at~     implementing the toolbox and its affects.~   "
233198|NCT00503724|"~     RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin in~     treating young patients with refractory primary brain tumors.~   "
233199|NCT00503711|"~     An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in~     Chinese patients with advanced solid malignant tumors.~   "
233200|NCT00503698|"~     This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.~      The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on~     survival (primary end-point; time to death and health related quality of life in adult~     patients on chronic haemodialysis.~   "
233201|NCT00503685|"~     Patients with mCRC who have progressed on a prior Anti-EGFr regimen randomized to receive~     IMC-A12 monotherapy or combination therapy with cetuximab to assess response, survival,~     durations of response, safety and tolerability as well as pharmacodynamics of IMC-A12 and~     cetuximab~   "
233204|NCT00503646|"~     RATIONALE: Participating in a therapy program may enhance communication and intimacy between~     men with prostate cancer and their partners.~      PURPOSE: This randomized clinical trial is studying how well therapy enhances communication~     and intimacy for men with early stage prostate cancer and for their partners.~   "
233206|NCT00503620|"~     Botulinum toxin injections are a common form of treatment for children with cerebral palsy to~     help reduce muscle tightness and help them walk without resorting to surgery. While the~     treatment is beneficial, it requires that the therapy be repeated every six months, which can~     be costly and may eventually result in the therapy not being effective over time. The study~     being conducted at Shriners Hospitals for Children, Philadelphia, will examine the effects of~     botulinum toxin injections, not only on walking, but on the changes it causes in the muscle,~     brain and spinal cord. The changes in the muscle, brain and spinal cord, called neuromuscular~     plasticity, have not been extensively examined in response to botulinum toxin, and could~     provide insight into how botulinum toxin works and how to make it more effective. This study~     will focus on children with cerebral palsy between the ages of 4 and 12 years, with only one~     leg involved and who would normally be receiving botulinum toxin injections of the lower leg~     to help improve walking. The children will be asked to come into the hospital for a full day~     before they receive the injection, and then again after four and twelve weeks to look at the~     changes in the muscle, brain and spinal cord. This will involve recording them while they~     walk, measurements of the muscle reflexes, and recording their brain activity while the move~     their ankle (also known as functional magnetic resonance imaging or fMRI). A group of~     children with typical development will also be asked to participate in the study to act as a~     comparison group. The researchers believe that examining the changes in the muscles, brain~     and spinal cord in response to the injection will aid in the understanding how better to use~     botulinum toxin to achieve better or longer lasting changes.~   "
233207|NCT00503607|"~     This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA~     approved bowel preparation in adult subjects undergoing colonoscopy.~   "
233208|NCT00503594|"~     The purpose of this study is to evaluate two types of chemotherapy for primary central~     nervous system lymphoma in the elderly (age older than 60) :~        -  Methotrexate, procarbazine, vincristine and cytarabine~        -  Methotrexate and temozolomide~   "
233209|NCT00503581|"~     This randomized phase II trial is studying how well megestrol works in treating patients with~     endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of~     endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by~     blocking the use of estrogen by the abnormal cells.~   "
233210|NCT00503568|"~     RATIONALE: Vaccines made from a person's tumor cells may help the body build an effective~     immune response to kill non-small cell lung cancer cells.~      PURPOSE: This phase I trial is studying the effects of gp96-Ig vaccine therapy in treating~     patients with stage III, stage IV, or relapsed non-small cell lung cancer treated with~     first-line chemotherapy.~   "
233211|NCT00503555|"~     The purpose of this study is the creation of a PBRN that will comprise primary care~     providers, community health organizations, community advocates and a research core of two~     academic institutions in order to study the healthcare needs of a rapidly growing immigrant~     population.~   "
233212|NCT00503542|"~     Many women present in primary care with vaginal complaints. The best way of managing these~     complaints is unclear. This trial will test two different methods of managing patients with~     vaginal complaints. This is a pilot trial.~   "
233213|NCT00503529|"~     The purpose of this study is to assess:~        -  TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first~          booster TBE vaccination with FSME-IMMUN 0.5ml given in Study 223, by means of ELISA~          (IMMUNOZYM FSME IgG) and Neutralization test (NT),~        -  TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the~          present study, by means of ELISA and NT,~        -  Safety of FSME-IMMUN 0.5ml after the second booster vaccination.~   "
233214|NCT00503516|"~     The purpose of this study is to demonstrate the efficacy of megestrol acetate in the gain of~     body weight in patients with primary or mixed Dementia with a weight loss.~   "
233215|NCT00503503|"~     The objective of this surveillance is to determine the following items in all patients~     receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset~     (frequency, severity and other details) of adverse events, 3) factors considered to affect~     the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other~     details) of the followings will be key issues of this surveillance:Infection (tuberculosis,~     opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor,~     interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and~     application site reactions.~   "
233216|NCT00503490|"~     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory~     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which~     has been particularly problematic to eradicate and been implicated as the major cause of~     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung~     increases the local concentrations of antibiotic at the site of infection resulting in~     improved antimicrobial effects compared to systemic administration. Bacterial resistance to~     current aerosol antibiotic treatments indicate a need for improved therapies to treat CF~     patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and~     other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to~     have antimicrobial effects on even the most resistant organisms and reduce the emergence of~     resistant bacteria.~   "
233217|NCT00503477|"~     A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171~     following single and multiple oral doses in patients in Japan with advanced solid~     malignancies. In addition there will be an expanded cohort multi-centre study phase with~     NSCLC patient and CRC patients~   "
233218|NCT00503464|"~     This project involves a comprehensive assessment of barriers to diabetes guidelines adherence~     across 25 practices in the Crozer-Keystone primary care PBRN. A Barrier Assessment Tool (BAT)~     will be validated to correlate with provider and practice adherence to diabetes care~     guidelines. The network is part of the Crozer-Keystone Health System located in Delaware~     County, Pennsylvania, in the southeast quadrant of the Philadelphia metropolitan region.~   "
233219|NCT00503451|"~     The primary purpose of this open-label study is to investigate the interaction of~     ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid~     tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in~     patients with advanced solid tumors.~   "
233220|NCT00503438|"~     This post market outcome study will look at the therapeutic results of the Salto Talaris~     Anatomic ankle prosthesis. The study population will consist of patients who will undergo an~     ankle arthroplasty procedure with a Salto Talaris ankle implant. An analysis will be~     conducted of the results, complications and revisions of this prosthesis based on the~     etiology for which the ankle arthroplasty was performed.~   "
233221|NCT00503425|"~     This single arm study will evaluate the safety and efficacy of MabThera in participants with~     active rheumatoid arthritis who have had an inadequate response to prior treatment with~     DMARDs and/or anti-TNF alpha agent. Participants will be treated with MabThera 1000~     milligrams (mg) intravenously (IV) on days 1 and 15. Participants were followed every 8 weeks~     to complete 24 weeks of follow-up. After completion of the Week 24 visit, the participants~     were followed every 3 months for up to 18 months for an overall study duration of 24 months~     (104 weeks). After week 36, eligible participants who achieve moderate or good response~     according to the European League Against Rheumatism (EULAR) response criteria will receive~     re-treatment with MabThera. Participants will receive concomitant treatment with DMARDs,~     corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics throughout the~     study period. The anticipated time on study treatment is 2 years, and the target sample size~     is 200 participants.~   "
233222|NCT00503412|"~     Open, non-randomised, radiolabelled, single centre study with a total of six patients with~     solid metastatic tumors to determine the rates and routes of elimination of 14C-AZD2171 and~     its metabolites.~   "
233223|NCT00503399|"~     The objective of this study is to test the hypothesis that teriparatide is superior to the~     active comparator in the change from baseline to 18 months of lumbar spine volumetric~     trabecular bone mineral density (BMD) in males with glucocorticoid-induced osteoporosis.~   "
233224|NCT00503386|"~     The purpose of this study is to determine whether palonosetron is tolerate and effective in~     preventing chemotherapy-induced nausea and vomiting in oriental population. The study is~     comparing the safety and efficacy of palonosetron with granisetron, a frequently used~     antiemetic in China.~   "
233225|NCT00503360|"~     This study will evaluate the tolerability and safety of SAD448 and explore the compound's~     effect on intraocular pressure in subjects with ocular hypertension.~   "
233226|NCT00503347|"~     This trial is designed to assess the safety, tolerability, pharmacokinetics and viral~     kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV.~   "
233227|NCT00503334|"~     The purpose of this pilot study is to investigate the effect of an oral nutritional~     supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing~     elective pancreaticoduodenectomy.~   "
233228|NCT00503321|"~     A randomized controlled study is conducted on unresectable advanced gastric carcinoma and~     recurrent gastric carcinoma to compare TS-1 therapy with TS-1 + PSK therapy. The primary~     endpoint of this study is progression-free survival (PFS), with secondary endpoints of~     anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug~     reactions and immunological factors.~   "
233229|NCT00503308|"~     The purpose of the study is to determine whether an abbreviated pretest/post-test CDC~     recommended counseling is as equally acceptable to prenatal patients as the standard strategy~     using prenatal care nurses and medical providers at San Francisco General Hospital [SFGH]).~   "
233230|NCT00503295|"~     The purpose of this Phase 2 study is to investigate whether intravenous administration of~     REOLYSIN® therapeutic reovirus is safe and effective in the treatment of patients with bone~     and soft tissue sarcomas metastatic to the lung.~   "
233231|NCT00503282|"~     In the era of emerging antibiotics resistant microbiology, we look for better outcome in the~     treatment of infections in the elderly.~      We look for guidelines to manage an elderly who has a permanent urinary catheter, admitting~     to E.R. with Fever/Sepsis.~      We assume that exchanging the permanent urinary catheter prior to the Urine Culture sample as~     well as for initiating antibiotic treatment will improve the outcome of the patients.It could~     help the day-to-day fight for the proper antibiotics treatment to avoid resistance.~   "
233232|NCT00503269|"~     Background: Local anaesthetic day-care open haemorrhoidectomy (LH) is feasible, cheap and may~     be the cost-effective surgical approach to third degree haemorrhoids. This prospective~     randomised controlled trial compares patient's evaluation of LH with general anaesthetic~     day-care Park's modified Milligan-Morgan haemorrhoidectomy (GH).~      Methods: 41 patients with third degree haemorrhoids were randomised to LH (19 cases) and GH~     (22 cases). Demographics were comparable. Independent assessment (by a research nurse) and~     clinical evaluation ran parallel for 6 months. Outcome measures were average and expected~     pain scores for 10 days; satisfaction scores at 10 days, 6 weeks and 6 months. Secondary~     outcomes were journey time and cost in day surgery.~   "
233233|NCT00503256|"~     The goal of this research is to identify genes that may be related to the risk of developing~     CLL.~      Objectives:~      The objective of this study to investigate possible candidate susceptibility genes for~     familial chronic lymphocytic leukemia (CLL) by identifying and recruiting high-risk families.~     Through our ongoing study of familial aggregation in CLL kindreds (protocol 2003-0498~     'Genetic Study of Chronic Lymphocytic Leukemia'), we have identified CLL patients who have~     one or more living or dead relative(s) affected with CLL or other leukemias or lymphomas. We~     will also identify patients in high-risk families from referrals from leukemia clinicians and~     from self-referrals from patients who learn about our study from the ClinicalTrials.gov~     website. We plan to invite probands (patients diagnosed with CLL) and their family members~     with other leukemias and lymphomas and a sample of unaffected relatives to participate in a~     genetic/linkage study. We will obtain demographic and clinical information along with~     specimens (blood or buccal samples) from all participants. These families will be part of the~     Genetic Epidemiology of CLL Consortium, a multicenter, multidisciplinary consortium, based at~     the Mayo Clinic Cancer Center under the direction of Susan Slager, PhD. This is funded from~     NCI through a subcontract with Mayo Clinic.~      Genotypic data will be analyzed at Mayo Clinic, and coded, de-identified data will be shared~     with the NIH Genome-Wide Association Studies (GWAS) data repository.~   "
233234|NCT00503243|"~     The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given~     twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in~     subjects with acute, mild to moderate ulcerative colitis.~   "
233235|NCT00503230|"~     The purpose of this study is to develop and evaluate a brief clinic-based culturally tailored~     smoking cessation treatment for a largely low-income, Latino, HIV+ population. We will~     compare this Culturally-Tailored Intervention (CTI) that incorporates a strong social support~     component and is targeted to the special needs and concerns of a Latino population to a~     Standard Care Intervention (SCI) control condition, in a randomized controlled trial. We~     hypothesize that those Latinos receiving the CTI will demonstrate greater biochemically~     verified smoking abstinence rates at 12-months post-baseline than those receiving the SCI~     control treatment. All study participants and their participating social supports will be~     offered use of the nicotine patch.~   "
233236|NCT00503217|"~     The aim of this study is to assess whether GnRH agonist administration in the luteal phase~     improves pregnancy outcome in intrauterine insemination (IUI) cycles.~   "
233237|NCT00503204|"~     This is a Phase I, open-label, multi-centre study designed to assess the safety and~     tolerability of Cediranib in combination with lomustine in patients with primary recurrent~     malignant brain tumour.~   "
233238|NCT00503191|"~     The purpose of this study is to determine whether NeuroModulation Technique (NMT) is~     effective in reducing maladaptive behaviors and increasing adaptive behaviors in children~     diagnosed with autism.~      Hypothesis: Children in the Experimental group will show significant improvement over the~     Wait-List control group as measured by the Pervasive Developmental Disorder Behavioral~     Inventory (PDDBI), the Aberrant Behavior Checklist, Community Version (ABC-C), and the Autism~     Treatment Evaluation Checklist (ATEC). Children in the Wait-List control group will show~     significant improvement over their baseline measures after receiving NMT treatment.~   "
233239|NCT00503178|"~     Highly selective irradiation requires accurate target definition by high-resolution~     three-dimensional imaging. Co-registration of FDG-PET and high-resolution CT might be the~     imaging modality of choice. This choice might target radiation therapy precisely to the~     intra-osseous volume that is responsible for pain and to spare selectively healthy bone in~     the vicinity of the metastasis. This strategy could result in equal anti-pain efficacy as~     conventional large volume radiotherapy, but could allow bone remodeling and preservation of~     bone structural strength in the vicinity and could lead to reduced toxicity to neighboring~     organs.~   "
233240|NCT00503165|"~     Menitorix is a combined Hib conjugate and meningococcal C conjugate vaccine made by~     GlaxoSmithKline. It is currently licensed and recommended as a booster vaccination for UK~     children in the second year of life.~      It is important that staff who have a potential occupational exposure to infectious disease~     are afforded protection where possible. The licensure and availability of Menitorix provides~     the opportunity to vaccinate such staff.~      Immune responses that are indicative of protection have been established for both Hib and~     meningococcal C disease. It is therefore proposed that the immune responses of those~     laboratory staff taking part be measured as data currently available following Menitorix~     vaccination is in naïve children and adults. This study will also allow us to provide~     occupational healthcare to laboratory workers.~      Participation in the study would be offered to all those staff considered to be at~     occupational health risk of Hib or meningococcal C disease at the Manchester HPA site. This~     will be a single group study in that everyone enrolled will receive a single dose of~     Menitorix and will have blood collected prior to and 4-6 weeks following vaccination.~      Assessment of whether protective levels of antibody have been achieved will be made using the~     blood sample taken 4-6 weeks after vaccination. Extra dose(s) will be offered to any subjects~     whose levels are not considered to confer protection as described later in this protocol.~     Subjects receiving and extra vaccination will be offered and a further blood test 4-6 weeks~     later to allow antibody levels to be checked again.~   "
233241|NCT00503152|"~     In people with type 2 diabetes, microalbuminuria is a strong, independent risk factor for~     diabetic nephropathy and cardiovascular morbidity and mortality. ACE inhibitor therapy~     decreased the risk of microalbuminuria in hypertensive subjects with type 2 diabetes and~     normoalbuminuria by about 40%. Available data suggest that angiotensin II receptor blockers~     (ARBs) might have a similar renoprotective effect and that this effect might be increased by~     combined ACE inhibitor therapy.~      The study will evaluate the effects, at similar blood pressure control (systolic/diastolic~     <130/80 mmHg), for a period of three years, of dual renin-angiotensin-system (RAS) blockade~     by benazepril and valsartan combination therapy as compared to single RAS blockade by~     benazepril or valsartan alone on microalbuminuria and cardiovascular events in high-risk~     patients with type 2 diabetes, creatinine <1.5 mg/dl, no evidence of microalbuminuria but at~     high risk of renal disease, with hypertension and a urinary albumin excretion between 7 and~     19 microgram/min. The relationship between albuminuria and cardiovascular outcomes will also~     be evaluated.~      The study is expected to show a more effective prevention of microalbuminuria and~     cardiovascular events with combined than with single drug ACE inhibitor or ARB therapy. As~     compared to ACE inhibitor, ARB therapy is expected to have a similar effect on~     microalbuminuria, but an inferior cardioprotective effect. Applied to clinical practice, the~     findings should help preventing renal and cardiovascular complications, and related treatment~     costs, of type 2 diabetes.~   "
233242|NCT00503139|"~     The special use-results surveillance is conducted in patients who have never been treated~     with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use~     after marketing with the following objectives: 1. To examine the safety of long-term use of~     Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in~     the long-term use.~   "
233243|NCT00503126|"~     Pharmacokinetics and safety of weight based bivalirudin in children~   "
233244|NCT00503113|"~     This 3 arm study will evaluate renal safety after administration of an intravenous (iv)~     injection or infusion of Bonviva, compared to oral alendronate, in patients with~     postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized~     to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months,~     or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12~     months, and the target sample size is 500+ individuals.~   "
233269|NCT00502788|"~     Hepatitis C is one of the most common causes of long-term liver disease in the United States.~     Ribavirin and peginterferon alfa-2a are two medications that are used to treat hepatitis C~     infection. The purpose of this study is to evaluate the safety of these two medications in~     adults with hepatitis C and thalassemia, a type of blood disorder.~   "
233245|NCT00503100|"~     Background: Several studies have indicated that infants who had undergone postnatal painful~     procedures appear to be hypersensitive to pain, with a lower threshold to tactile~     stimulations later on life.~      Objective: To study the effect of early exposure to pain on cerebral somatosensory evoked~     potential (SEP) response to thermal stimulation (550C), in preterm and full term born~     adolescents (15-18 years old), who have undergone painful procedures during their neonatal~     period. As well as to study the effect of early exposure to thermal and tactile sensory~     thresholds and pain thresholds to thermal and tactile stimuli, by using the TSA and von Frey~     hairs.~      Design: Case-control study.~      Participants: Four groups of 20 adolescents (aged 15-18 years), two of which are full term~     and preterm-born who were exposed to painful procedures during the neonatal period. The other~     two groups are term and preterm-born adolescents who were not exposed to such procedures.~      Main Outcome Measures: Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal~     stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation~     threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer~     (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by~     using Von-Frey hairs.~   "
233246|NCT00503087|"~     Each participant will be administered 2 injections of saline - the first in the right gluteal~     area and the second in the left gluteal area. Both injections will be administered~     intra-muscularly by the same clinician. One injection will be given with vacuum (Pneumatic~     Skin Flattening or PSF Machine) and the other without vacuum. The order of the injections~     will be randomly assigned. Each subject will serve as a control for himself. Between~     injections a 30 min pause will be given to minimize pain sensation bias of the previous~     injection. Immediately after each injection the pain level will be assessed by the VAS scale.~     The researcher assessing the pain will be blinded for the type of injection given. The~     evaluation of the pain reduction will be made by comparison of the pain level with and~     without the application of the PSF.~      Hypothesis: PSF Technique will reduce the pain associated with saline injections.~   "
233247|NCT00503074|"~     The purpose of this study is to determine whether a reduction in toddlers' and preschoolers'~     exposure to television advertising leads to a change in their diet.~   "
233248|NCT00503061|"~     To investigate how common it is that patients using Symibort SMART take high average daily~     doses that are not considered appropriate by their physician (overuse) or are hospitalised~     due to their asthma at least partly due to underuse.~   "
233249|NCT00503048|"~     There are many studies regarding possible causes of increasing trend in frequency of allergic~     diseases in the last three decades. Main causes of this trend are: decrease of infectious~     diseases frequency, improvement in life level, changes in diet and lactic acid bacterias~     elimination from digestive tract. Primary Purpose of this study is to compare the prevalence~     of atopy and atopic diseases in two child populations: foster care and reference children and~     - to define risk and protective factors for the development of atopy.~   "
233250|NCT00503035|"~     Primary Objective:~        -  To determine whether celecoxib downregulates GATA-6 expression to upregulate 15-LOX-1~          expression and induce apoptosis in human rectal tumors, researchers will measure GATA-6~          and 15-LOX-1 expression, 13-S-HODE levels, and apoptosis rates in normal and colorectal~          polyp epithelial tissues before and after 6 months of celecoxib treatment of patients~          with familial adenomatous polyposis (FAP).~   "
233251|NCT00503022|"~     This study evaluates the tolerability and safety of a single intravenous infusion of ACZ885.~     It also explores the efficacy of the compound in central macular edema and visual acuity in~     patients with wet age-related macular edema.~   "
233252|NCT00503009|"~     This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain~     clinic visits will include a physical examination, lung function tests, inflammatory cell~     analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA~     approved virus through their nose which is known to cause the common cold. All study related~     medications and medical examinations will be provided at no cost to the subject. The drugs~     used in this study are approved for the age group under study.~   "
233253|NCT00502996|"~     This single arm study will assess the safety of MabThera plus methotrexate in patients with~     rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents.~     Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate~     >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target~     sample size is 100-500 individuals.~   "
233254|NCT00502983|"~     Little is known about the epidemiologic risk factors associated with the development of acute~     myelogenous leukemia (AML), and less is known about the role that genetic susceptibility~     plays in the development of AML. We propose to conduct a population-based study to~     investigate genetic susceptibility in adult AML patients, both de novo and treatment-related~     in a well-defined geographical area. Using a case-control design, we will prospectively~     enroll 400 patients from Texas and 800 healthy controls. Controls will be recruited using~     random digit dialing, and will be matched to the cases by age, gender, and ethnicity.~     Epidemiological and demographic information will be obtained through personal interviews, and~     will be integrated with clinical information, cytogenetic data, and genotypic markers. Blood~     specimens will be collected on all participants, who will be genotyped for markers associated~     with activation and detoxification of chemical carcinogens, including chemotherapy drugs.~     Polymorphisms in genes such as cytochrome p450 (CYP2E1), glutathione S-transferases (GSTT1,~     GSTM1, GSTP1), epoxide hydrolase (HYL1), NADPH-quinone oxidoreductase (NQO1), and~     myeloperoxidase (MPO) will be analyzed.~      This study will provide insight into the role that these susceptibility markers, along with~     clinical epidemiological, and cytogenetic factors, play in the identification of people at~     risk of developing AML. Understanding how genetic predisposition and exogenous exposures~     interact to determine AML susceptibility will allow the development of prevention strategies~     in the future.~   "
233255|NCT00502970|"~     To determine if a shorter course of interferon and ribavirin therapy will be sufficient in~     carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared~     to the standard length of treatment of 6 months.~   "
233270|NCT00502775|"~     The primary objective of the study is to compare nighttime symptom relief of fluticasone~     furoate nasal spray versus oral fexofenadine~   "
247514|NCT00313235|"~     The purpose of this study is to test a combined treatment using cyclophosphamide and a novel~     dendritic cell vaccine in patients with Stage IV melanoma.~   "
233256|NCT00502957|"~     The purpose of this randomized, controlled trial is to examine how well biofeedback treatment~     works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1)~     anorectal-specific biofeedback therapy and 2) generalized biofeedback therapy using~     relaxation techniques.~      The study will also examine which medical and psychological factors determine biofeedback~     success for treating constipation, such as bowel habits, emotional reactions to constipation,~     and levels of stress and psychological distress.~   "
233257|NCT00502944|"~     This study will compare the effectiveness of two different approaches to providing routine~     HIV counseling, testing, and referral services in an urban hospital emergency department~     setting.~   "
233258|NCT00502931|"~     With the number of individuals becoming overweight or obese, healthcare professionals are in~     need of accurate, reliable, and convenient tools to help personalize weight loss programs.~     Recently, a new indirect calorimeter (i.e. MedGem / BodyGem; aka “Gem”) was introduced as a~     convenient solution to determine resting metabolic rate (RMR) for assessment of daily energy~     needs. Several validation and comparison studies were conducted to determine if the Gem~     device is accurate and reliable. The purpose of this study was to conduct a systematic review~     of previous studies that evaluated the accuracy and reliability of the Gem devices.~   "
233259|NCT00502918|"~     The study is a feasibility study to check the possibility of tracking the heart rate of the~     fetus and to translate the outcome to the progress of the labor~   "
233260|NCT00502905|"~     Primary Objectives:~        1. To administer multiple doses of an intravenous formulation of busulfan (Bu) at a dose~          adjusted to yield a blood drug level with a median daily area under the plasma~          concentration curve (AUC) of approximately 6,500 µMol-min. This dose will be given~          intravenously over three hours once daily for four (4) days, in combination with~          Fludarabine at a dose of 40 mg/m2 as preparation for bone marrow or peripheral stern~          cell transplantation in patients with acute myeloid leukemia or myelodysplastic~          syndromes.~        2. To determine the outcome of Acute Myeloid Leukemia (AML)/myelodysplastic syndromes (MDS)~          patients undergoing treatment with this regimen. Data regarding engraftment, toxicity,~          relapse rate, long-term (disease-free) outcome, and overall survival will be collected.~        3. To determine the safety profile of this regimen when utilized as preparation for~          allogeneic transplantation.~        4. To describe the plasma pharmacokinetics of busulfan when administered intravenously in~          this regimen.~   "
233261|NCT00502892|"~     Primary Objectives:~        -  To determine the maximum tolerated dose (MTD) of Topotecan when added to a fixed dose~          regimen of Ifosfamide and Carboplatin in children and young adults with solid tumors.~        -  To evaluate the toxicity associated with the administration of Topotecan with Ifosfamide~          and Carboplatin (TIC) in children and young adults with solid tumors.~      Secondary Objectives:~        -  To evaluate the duration of neutropenia (ANC<500/micro L) and thrombocytopenia (PLT~          50,000/ micro L and 20,000/ micro L) and the number of days of platelet transfusion~          during each course of TIC chemotherapy when used in conjunction with G-CSF and NEUMEGA~          in children and young adults with solid tumors.~        -  To determine the median number of apheresis collections as well as the CD34/kg, CD41/kg,~          CD61/kg and CD34:41/kg and CD34:61/kg per collection in patients electively undergoing~          concurrent apheresis for peripheral blood stem cell collection in courses 2 or 3.~        -  To determine the median number of peripheral blood mononuclear cells (PBMC) and ex-vivo~          expanded myeloid dendritic cells (DC) in patients electively undergoing concurrent~          apheresis for PBMC collection in courses 2 or 3.~   "
233262|NCT00502879|"~     The primary purpose of this study is to assess the pharmacokinetics of etanercept in healthy~     Chinese male subjects. Safety and tolerability data will also be obtained.~   "
233263|NCT00502866|"~     Some experts recommend that all breastfed babies receive supplemental vitamin D. The purpose~     of this study is to determine the rate of vitamin D use in breastfed babies, the~     recommendations of pediatricians regarding vitamin D, and the impact on these recommendations~     on parental choice of vitamin D. In addition, in preparation for a large study to see how~     many breastfed children who don't receive supplemental vitamin D have rickets, in this study~     we will determine if a simple blood test, an alkaline phosphatase level, could be used to~     screen for rickets. Parents of children 6-23 months old are eligible to complete feeding~     surveys and children 6-15 months old who were breastfed for at least the first six months of~     life and didn't routinely receive vitamin D are eligible for alkaline phosphatase levels. We~     postulate that most breastfed babies don't receive supplemental vitamin D, and that alkaline~     phosphatase levels will only be abnormal in a few babies who will have evidence on x-ray of~     rickets.~   "
233264|NCT00502853|"~     This single arm study will measure the effect of MabThera in combination with methotrexate on~     the progression of synovitis, the extent of bone marrow edema, and the number of erosions in~     the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients~     will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of~     10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera~     will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment~     initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated~     time on study treatment is 1-2 years, and the target sample size is <100 individuals.~   "
233265|NCT00502840|"~     This single arm study will evaluate the efficacy and safety of repeated courses of MabThera~     in patients with active rheumatoid arthritis who have participated in ML19070, and have~     completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2~     infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to~     3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2~     years, and the target sample size is 100-500 individuals.~   "
233266|NCT00502827|"~     The goal of this research study is to look at treatments that may help individuals who have~     HIV/AIDS to stop smoking.~   "
233267|NCT00502814|"~     The goal of this clinical research study is to characterize the 3-dimensional form and~     mechanical properties of the breast. Researchers want to do this in order to develop new high~     technology tools for improving the diagnosis and treatment of breast cancer in women.~   "
233268|NCT00502801|"~     The purpose of this study is to evaluate the effectiveness and safety of doripenem~     monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.~   "
233271|NCT00502762|"~     Although the efficacy of topotecan as second-line chemotherapy for SCLC has been consistently~     demonstrated in phase II/III clinical trials, the choice of irinotecan as first-line therapy~     prevented use of the evidence-based option.~      This pilot study will be conducted to determine the activity and safety of topotecan in SCLC~     patients refractory to first-line therapy with irinotecan and platinum.~   "
233272|NCT00502749|"~     This pilot study will examine the safety, feasibility, and effect on quality of life of~     moderate physical activity on adolescent and young adult patients who are admitted to the~     hospital periodically for routine chemotherapy. Patients will be asked to participate in~     daily physical exercise during hospital admissions over a three-month period. Exercise~     sessions will be monitored and guided by M.D. Anderson physical therapists, a personal~     trainer, and Dr. Michael Rytting, pediatric oncologist. The personal trainer will meet with~     each participant for reinforcement and to provide an opportunity for exercise between~     hospitalizations. If results are positive, the study will be extended to a larger cohort of~     patients.~   "
233273|NCT00502736|"~     This single arm study will assess the efficacy and safety of loading doses of intravenous~     Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to~     severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2~     and 3. The anticipated time on study treatment is 3 months, and the target sample size is~     <100 individuals.~   "
233274|NCT00502723|"~     National multicentric prospective open study, comparing two current surgical methods:~     laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy~     for a localised prostate cancer.~   "
233275|NCT00502710|"~     This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a~     DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be~     randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o.~     Patients receiving metformin before the study will continue on the same dose of metformin.~     The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
233276|NCT00502697|"~     Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent~     preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable~     to intervention. Home visitation is a promising method to deliver evidence based~     interventions. We evaluated a system of care designed to reduce preterm births and hospital~     length of stay in a sample of pregnant women with a history of a PTB. All participants (N =~     211) received standard prenatal care. Intervention participants (N = 109) also received home~     visits by certified nurse-midwives guided by protocols for specific risk factors (e.g.,~     depressive symptoms, abuse, smoking). Data was collected via multiple methods and sources~     including intervention fidelity assessments. Average age was 27.6 years. Racial breakdown~     mirrored local demographics. Most women had a partner, a high school education, and Medicaid.~     Enhanced prenatal care by nurse-midwife home visits may limit some risk factors and shorten~     intrapartum length of stay for women with a prior PTB. This study contributes to knowledge~     about evidence-based home visit interventions directed at risk factors associated with PTB.~   "
233277|NCT00502684|"~     Surgery for breast cancer has a major role in enhancing long term survival and cure, but~     several physiological aspects associated with surgery are implicated as enhancing tumor~     spread and formation of distant metastases. These include: an increase in pro-angiogenic~     factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and~     direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these~     pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely~     by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery.~      Studies have shown that surgery increases levels of catecholamines and prostaglandins, which~     in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance~     vascularization of micro metastases.~      Opiates given for pain relief during and after surgery have been reported to enhance tumor~     cell division and cause immune suppression.~      The immune system is significantly suppressed during surgery. This suppression has been shown~     to affect the systemic resistance to infection as well as neoplastic metastatic processes.~      Several studies have shown that increased levels of catecholamines and prostaglandins add to~     the immune suppression.~      Studies in rats found that peri-operative administration of the beta beta-blocker propranolol~     together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell~     activity as well as the risk for distant metastases.~      A recent retrospective clinical study found that among breast cancer patients treated with a~     combination of regional anesthesia and a COX inhibitor the recurrence rated were~     significantly less than among patients undergoing surgery without these two interventions.~      The purpose of the proposed prospective trial is to examine if peri-operative administration~     of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression~     of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates.~      In the proposed study breast cancer patients will be treated with a combination of a~     beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control~     group of healthy women will serve as untreated controls). The variables which will be~     examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress~     hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2~     cytokines as a result of in vitro stimulation.~      In addition to these immediate parameters, long term follow up will be conducted in order to~     determine the effect of the intervention on long term cancer recurrence over five years.~      Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with~     regard to the known risk factors for recurrence such as tumor grade, lymph node involvement~     etc. Sample size for immunological parameters will be 40 patients in each group and 20~     healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil~     be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50%~     reduction in cancer recurrence at an α of 0.05.~   "
233278|NCT00502671|"~     This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant~     treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as~     intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week~     without treatment). The anticipated time on study treatment is 3-12 months, and the target~     sample size is 500+ individuals.~   "
233279|NCT00502658|"~     Excessive body weight is becoming a concern around the world, for example over half of the~     American adult population is overweight or obese. The purpose of this study is to determine~     whether dietary supplements and shakes containing a combination of nutrients/ingredients~     individually shown in research studies to reduce hunger, enhance metabolism, reduce the~     body's ability to 'store' fat, and enhance energy, promote healthy body weight and~     composition over 12 weeks. A further study objective is to determine whether the inclusion of~     a personal, easy to use, energy tracking device for the measurement of daily energy intake~     and expenditure also helps with the promotion of healthy body weight and body composition.~      In this prospective, blinded study 120 volunteers who meet the entrance criteria including a~     BMI 25-35 kg/m2 and sign the informed consent form to participate in a 12 week long study~     will be recruited. All subjects will consume a multi-vitamin, mineral and fish oil~     supplement. Subjects will be randomly assigned to a control or experimental group and~     stratified by BMI 25-30 and >30-35 kg/m2, age, and gender with an equal number of subjects in~     each strata across groups. A subset of subjects will also wear a personal energy tracking~     device. Subjects will be instructed how to incorporate the shakes and supplements into their~     current diet and encouraged to incorporate fruits, vegetables, whole grains, and other~     healthy foods into their current meals and to exercise at least 30 minutes five days per~     week.~   "
233280|NCT00502645|"~     This is a single-center, open, non-controlled clinical investigation in 10 patients at the~     Medical University Graz including a treatment visit (V1)and a follow up visit(V2). In the~     treatment visit (V1) after admittance to the ICU arterial blood glucose values will be~     monitored and either the software-algorithm eMPC will be used to adjust the infusion rate of~     intravenously administered human soluble insulin to normalise arterial blood glucose. The~     purpose of the present study is to investigate the performance of the already developed and~     tested algorithm in combination with a newly developed bed-side, touch screen user interface~     (CS-1 decision support system) in patients at the medical ICU for a period of 72 hours.~     Follow up information(V2) will be acquired at hospital discharge or at the latest one week~     after visit 1.~   "
233281|NCT00502632|"~     The purpose of this study is to determine whether intrapleural treatment with Dornase alfa~     plus Urokinase improves clinical outcome compared to Urokinase alone in children with~     complicated parapneumonic effusions~   "
233282|NCT00502619|"~     The purpose of this research proposal is to conduct a feasibility study to determine the~     viability a larger efficacy study of combined acupuncture treatments plus treadmill exercise~     to decrease pain, facilitate exercise, and improve function in Veterans with chronic low back~     pain (CLBP). To test this novel approach, subjects enrolled from a Veteran population at the~     Veteran Affairs Maryland Health Care System (VAMHCS) will undergo acupuncture plus low~     intensity treadmill walking exercise. Preliminary data regarding subject compliance,~     self-report of function, pain control, ambulatory activity, and exercise capacity will be~     collected to assess the response to this combined acupuncture/treadmill exercise protocol.~     Additionally, this study will determine the viability of this combined treatment paradigm for~     a larger study that will examine efficacy.~   "
233283|NCT00502606|"~     The effect of Antibacterial Nanoparticles, Incorporated in cement, on S.mutans in the margins~     of provisional restorations is going to be examined clinically by using two kinds of~     provisional cement 1. cement with out antibacterial nanoparticles.~      2.cement with small addition of IABN. after one week in the mouth the crowns are to be~     removed and examined for the presence and quantity of s. mutans. in vitro tests of the same~     has shown significant reduction in bacterial population around the provisional cement as~     compared to the regular cement.~   "
233284|NCT00502593|"~     The present study is designed to evaluate in children (aged between 3 and 9 years) the~     immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A)~     administered following a two-administration schedule (21 days apart). Subjects in the control~     group will receive Fluarix. The Protocol Posting has been updated in order to comply with the~     FDA Amendment Act, Sep 2007.~   "
233285|NCT00502580|"~     To obtain data to evaluate whether multispectral digital imaging can assist clinicians to~     screen for premalignant lesions in the oral cavity. Our system will illuminate tissue with~     monochromatic light to excite fluorescence, and polarized white light to generate~     reflectance, exposing abnormalities for real time, clinical diagnosis.~      Primary Objectives:~        1. To compare fluorescence images of oral mucosa lesions, obtained at 350 nm, 380 nm, 400~          nm, and 450 nm excitation, to standard white light images and pathologic analysis of~          biopsied tissue.~        2. To compare reflectance images of oral mucosa lesion, obtained using broadband polarized~          light, to standard white light images and pathologic analysis of biopsied tissue.~        3. To develop algorithms to discriminate between normal and abnormal tissue~        4. To analyze images to determine which type of optical information (or combination~          thereof) yields the most diagnostically useful data~   "
233286|NCT00502567|"~     A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of~     AZD2171 when administered with various anticancer regimens (part A) and to confirm the~     tolerability of its combination with FOLFOX (part B).~   "
233287|NCT00502554|"~     Investigation of photopheresis as new therapy regimen in patients with bronchiolitis~     obliterans syndrome after lung transplantation in a controlled, randomized study~   "
233288|NCT00502541|"~     This was a multi-center, randomized, masked, parallel-group, controlled study in patients~     with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of~     care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the~     safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of~     patients with diabetic macular edema.~   "
233289|NCT00502528|"~     Background and Objective: Acute coronary syndrome is characterized by compromised blood flow~     at the epicardial and microvascular levels. The aim of the present study is to investigate~     the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an~     adjunct to PCI-reperfusion therapy in patients with STEMI.~      Patients are randomized to receive periinterventional intravenous BQ-123 or placebo.~   "
233290|NCT00502515|"~     The primary objective of this sudy is to assess the effect of two doses of SSR180575 on the~     rate of regeneration of epidermal nerve fibers following denervation of the epidermal layer~     with capsaicin in patients with diabetes mellitus and mild peripheral neuropathy. Secondary~     objectives are to explore the efficacy of SSR180575 on clinical assessment, nerve function~     measures and to assess the tolerability and safety of SSR180575. The treatment period is 6~     months.~   "
233291|NCT00502502|"~     Primary Objectives:~        -  To determine the feasibility of a study that would describe changes of certain~          circulating inflammatory cytokines (interleukin-1, 6, 8, 10, 12, and tumor necrosis~          factor-alpha [TNF] and symptoms related to chemoradiation therapy (pre-therapy, during~          therapy and up to 3 months post-therapy) among patients with lung, esophageal, gastric,~          colorectal and anal cancer.~        -  To determine the feasibility of studying neurocognitive function in patients with~          non-small cell lung cancer (NSCLC) at presentation and during chemoradiation therapy to~          determine the prevalence, severity, and pattern of cognitive symptoms.~   "
233306|NCT00502307|"~     This phase 2 trial is evaluating the antineoplastic activity of tivozanib (AV-951) in~     treating patients with recurrent or metastatic renal cell cancer. Tivozanib (AV-951) is a~     VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking~     blood flow to the tumor.~   "
233307|NCT00502294|"~     To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on~     Days 1 and 2 to placebo in subjects with IVSR-UC.~   "
247571|NCT00312494|"~     3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex~     in acutely manic subjects~   "
233292|NCT00502489|"~     After an episode of acute respiratory failure requiring mechanical ventilation, weaning the~     patient from the ventilator may be difficult. Discontinuation of ventilation is estimated to~     take up to 40% of the total duration of ventilatory support. Approximately two- thirds of~     patients can be disconnected from the ventilator after a spontaneous breathing trial.~     Prolongation of mechanical ventilation may increase the risk of adverse events such as~     infections and can increase morbidity and mortality.~      Identifying weaning readiness early and reliably is therefore crucial. Weaning protocols~     developed to assist in identifying weaning readiness have been shown to shorten duration of~     mechanical ventilation, most notably the weaning period.~      Closed loop knowledge-based systems serve as a continuously applied weaning process that~     automatically reduce ventilatory assistance according to patient ability and indicate when~     the patient is ready for disconnection. No data on the use of such a computer driven system~     (CDS) in elderly patients requiring prolonged ventilation in weaning centers (non ICU) have~     been reported.~      The Objective of the present study is to evaluate the ability of a computer driven system to~     predict weaning readiness and to compare this to a physician-directed protocol. The CDS~     continuously adapts pressure support, gradually decreasing ventilator assistance according to~     patient ability, and thus indicates weaning readiness. Patients who maintain spontaneous~     breathing for 7 days following weaning will be considered to be successfully weaned from~     mechanical ventilation.~   "
233293|NCT00502476|"~     To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the~     incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.~   "
233294|NCT00502463|"~     The purpose of the trial is to determine the feasibility of an induction chemotherapy with~     radio-immunotherapy in patients with head and neck cancer stage III/IV~   "
233295|NCT00502450|"~     Following acute mastoiditis there is a possible risk to develop hearing loss. The cause could~     be either possible involvement of the inner ear, or in cases that underwent surgery,~     secondary to the effect of the drill's noise. Extended hearing test will be performed for 25~     children that suffered acute mastoiditis that resolved with conservative treatment and~     compared with 25 children that needed surgical intervention.~   "
233296|NCT00502437|"~     Antigagging effect of kytril (granisetron) an antiemetic drug in dental situations~      Gagging in dental situations can be a problem to the patient and the operating dentist. There~     are not proven methods of eliminating this reflex which sometimes will not allow routine~     quality dental care.~      Pharmacological and behavioral approaches to eliminate this reflex have been tried with~     limited success.~      This suggested study will test a potent antiemetic drug used in other clinical situations~     such as antineoplastic treatment. Granisetron is a potential antagonist for the~     5-hydroxytryptamine3-receptor - 5HT(3), The drug binds to the receptor and blocks the effect~     of nausea and vomiting. Kytril mechanism of action was successfully proven for various~     medical situations as a potential antiemetic agent. Our Center for dental sedation and~     anesthesia in the oral medicine department have received approval to use Granisetron as an~     antigagging drug in dental situations based on several pilot studies conducted in other~     medical centers in different clinical situations such as strabismus corrections, post~     hysterectomy and others. Our preliminary clinical impression is that pre-emptive IV~     administration of this drug to patients with increased gag reflex is beneficial.~      In our research we try to investigate the possibility of using kytril in dental situations.~      In the first stage of this research we will study the INTRAVENOUS use of this drug and its~     effects On normal subjects compare them to themselves with placebo. According to the results~     of this study we will go on to the second stage of the research and try the same drug under~     oral administration.~      The purpose of this study is to test the antigagging effect of this drug in a controlled~     manner in dental situations.~      Our working hypothesis is that administration of this drug in dental situations with success,~     will allow many patients to receive good dental care~   "
233297|NCT00502424|"~     The purpose of the present study was to evaluate the effectiveness of a nighttime positioning~     hand splint in patients with RA in terms of pain, grip and pinch strength, upper limb~     function, quality of life, and patient satisfaction. The hypothesis is that the stabilization~     of hand during nighttime could decrease pain and consequently improve quality of life.~   "
233298|NCT00502411|"~     The goal of this clinical research study is to learn if the combination of radiation therapy~     plus low dose doxorubicin chemotherapy given after surgery is effective in the treatment of~     sarcoma. The safety of this treatment will also be studied.~   "
233299|NCT00502398|"~     Patients with hemolytic disorders (e.g. sickle cell anemia or thalassemia) are known to~     develop pulmonary hypertension. Hemolysis is where red blood cells are destroyed and their~     contents released into the circulation. It is thought that these red-cell contents cause~     constriction and thrombosis of the blood vessels in the lungs. Conversely, it is possible~     that patients with pulmonary hypertension have hemolysis.~      In this study we will be drawing blood from a range of patients and normal controls for a~     panel of blood tests related to hemolysis.~   "
233300|NCT00502385|"~     The study will be conducted across multiple European centres to assess the safety and~     tolerability of multiple doses of AZD2171 in patients with AML.~   "
233301|NCT00502372|"~     The focus of this study is to look at the role of nutrition in the healing of pressure~     ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers~     is increased in those patients receiving a nutritional supplement of amino acids and the~     leucine metabolite, B-hydroxy-B-methylbutyrate is enhanced when compared to control patients~     receiving a supplement containing only one of the proteins in the experimental supplement~   "
233302|NCT00502359|"~     Present practice: Measurement of fasting glucose values in 2nd trimester of pregnancy, if~     above 4.8 mmol/l, a Glucose Tolerance Test is performed. (Two-step procedure: 1. Appointment~     for the fasting glucose measurement, 2. Appointment for the Glucose Tolerance Test)~   "
233303|NCT00502346|"~     The primary objective of the study is to compare the effect of PM101 I.V. administered as an~     immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives~     include evaluation of change from baseline in heart rate and change from baseline to the~     lowest value in mean arterial pressure and diastolic pressure.~   "
233304|NCT00502333|"~     The purpose of this study is to evaluate the influence of coping strategies and~     catastrophizing thoughts on disability and the prognosis of back and neck pain in patients~     treated within the Spanish National Health Service. Patients will be given a visual analog~     scale (VAS) to rate intensity of pain, the Roland Morris Questionnaire (RMQ) or the Neck~     Disability Index (NDI) to rate the degree of disability, and the Coping Strategies~     Questionnaire (CSQ) to rate coping strategies and catastrophizing. Questionnaires will be~     given at baseline and three months later.~   "
233305|NCT00502320|"~     The purpose of this study is to determine whether treating sleep difficulties in patients~     with seasonal affective disorder also improves their depressive symptoms.~   "
233319|NCT00502125|"~     The objective of this study is to evaluate the feasibility of using reflectance confocal~     imaging to noninvasively detect and diagnose oral dysplasia and early carcinoma.~   "
233308|NCT00502281|"~     At the present the first options to induce ovulation in polycystic ovary syndrome with~     anovulatory infertility are clomiphene citrate (CC) and metformin. Notwithstanding the~     effectiveness of CC and metformin alone or in a sequential or combined regimen, a percentage~     of patients ranging from 5% to 30% remain anovulatory. For these patients, the use of~     gonadotropins for controlled ovarian stimulation (COS) is indicated.~      Moreover, to date it isn't clear if COS should be followed by timed intercourse (TI) or~     intrauterine insemination (IUI).~      The aim of the present study will be to compare TI and IUI in infertile PCOS patients~     undergoing COS in terms of cost-benefit.~   "
233309|NCT00502268|"~     Arterial calcification within the coronaries and other vessels is greatly accelerated among~     patients with chronic or end-stage kidney disease. The mechanisms leading to increased~     calcification are unknown, but include hyperphosphatemia, hyperparathyroidism and altered~     vitamin D metabolism. Moreover, recent data demonstrates that circulating carboxy fragments~     of PTH (7-84) are physiologic antagonists of intact PTH (1-84) and may directly contribute to~     vascular calcification. Current PTH assays no not distinguish between intact and carboxy PTH~     fragments leading to an overestimation of intact PTH levels. Because second generation PTH~     assays detect both 1-84 and 7-84 PTH fragments, the use of vitamin D analogues to treat~     secondary hyperparathyroidism could lead to excessive suppression of 1-84 and a preponderance~     of carboxy PTH fragments. Moreover, increased administration of vitamin D analogues amy~     contribute to vascular calcifications. To investigate these questions, we plan to investigate~     the effect of managing new ESRD patients using conventional and third generation PTH assays~     on vitamin D administration and the development of coronary calcification. Hypothesis #1:~     Clinical management of secondary hyperparathyroidism in new hemodialysis patients using the~     Scantibodies 1-84/7-84 PTH ratio for one year will reduce the amount of Vitamin D~     administration resulting in reduced coronary calcification compared to patients in which PTH~     management is accomplished by conventional, second generation PTH assay.~   "
233310|NCT00502255|"~     The purpose of this study is to investigate if telemonitoring results in a decrease in~     hospital admissions, with equal quality of care defined as mortality, quality of life and~     unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than~     usual care in patients with heart failure.~   "
233311|NCT00502242|"~     The primary objective of the study is to determine the efficacy of ramipril in preventing a~     urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to~     sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.~   "
233312|NCT00502229|"~     Several data demonstrated that both clomiphene citrate (CC) and metformin are two safe and~     valid first-step options to induce ovulation in infertile anovulatory PCOS patients.~     Notwithstanding a high percentage of patients ovulate under treatment, only ~40% and 60% of~     subjects obtain a pregnancy after CC and metformin, respectively.~      For these patients, controlled ovarian stimulation (COS) followed by intrauterine~     insemination (IUI) could be the next therapeutic step before assisted reproductive techniques~     since IUI improves significantly the fertility in couples with unexplained infertility.~     Furthermore, to date it is not defined if COS should be obtained using the same ovulatory~     agent (CC or metformin) or switching the treatment to gonadotropins.~      In this view, the aim of the present study will be to evaluate the best management of~     infertile PCOS patients ovulating after CC or metformin.~   "
233313|NCT00502216|"~     The purpose of this study is to determine whether the combination of naltrexone (Depade) and~     varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the~     combination is tolerated.~   "
233314|NCT00502203|"~     The goal of this clinical research study is to find out if the combination of paclitaxel and~     carboplatin chemotherapy can shrink or slow the growth of mixed mullerian tumors (MMMT) of~     the uterus.~   "
233315|NCT00502190|"~     Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients~     with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea~   "
233316|NCT00502177|"~     Objectives:~      The overall objective of this prospective study is to provide a descriptive analysis of the~     quality of life of cancer patients enrolled on M. D. Anderson Cancer Center Protocol~     2009-0528, A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and~     Young Adults with Desmoplastic Small Round Cell Tumor (DSRCT) and Other Non-carcinomas.~      Specific Aim 1: To examine the quality of life of patients who undergo HIPEC longitudinally.~     It is hypothesized that physical health and functioning concerns, as reported by parent/child~     dyads on the Pediatric Quality of Life Cancer Module Version 3.0 (PedsQL) and the PedsQL 4.0~     Generic Core Scales, will will remain stable or improve, following the surgical procedures~     and peritoneal perfusion described in Protocol 2009-0528.~      Specific Aim 2: To assess parent and patient perception of the relative benefit of HIPEC~     longitudinally. It is hypothesized that parents and patients will perceive HIPEC to be~     beneficial across time, despite the temporary postoperative pain and discomfort that is~     associated with the procedure. This will be done by means of a non-validated question that is~     specific to the surgery.~      Exploratory Aim: To determine whether quality of life following HIPEC varies by demographic~     factors (e.g., age, culture), intraoperative cisplatin dose level, or subsequent treatment~     modalities. Some patients who undergo HIPEC might subsequently be treated with other Phase II~     chemotherapy agents and/or palliative radiation, and comparing quality of life in these~     subgroups will be of value. Also the quality of life for groups of patients enrolled in~     Protocol 2009-0528 at each intraoperative cisplatin dose level will be compared.~   "
233317|NCT00502164|"~     A study to assess safety and tolerability of AZD2171 after multiple doses in patients with~     advanced prostate cancer.~   "
233318|NCT00502138|"~     This research project will investigate the effects of pramlintide (Symlin) given by~     continuous subcutaneous (under the skin) infusion throughout the day and night, along with~     meal doses similar to those injected during conventional pramlintide (Symlin) treatment,~     delivered using a second insulin pump, in subjects with inadequately controlled type I~     diabetes mellitus who are already using insulin pump therapy. Study participants will wear~     two pumps for a four month period, taking insulin in their usual manner and pramlintide~     (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three~     occasions during the study to assess blood glucose responses to continuous pramlintide~     (Symlin) treatment.~   "
233320|NCT00502112|"~     This study is a phase I, open-label, single-arm, dose escalation trial to determine the~     safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small~     groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and~     lintuzumab and will receive 3-week cycles of combination therapy.~   "
233321|NCT00502099|"~     Genotype 4 hepatitis C virus is the cause of approximately 20% of the 170 million cases of~     chronic hepatitis C in the world. Although rare in western nations, genotype 4 is the most~     common variant of the hepatitis C virus in Egypt and is also found throughout Africa and the~     Middle East. Early reports on the treatment of patients with genotype 4 chronic hepatitis C~     with interferon-alfa (IFN)-alfa monotherapy indicate poor rates of sustained viral response~     (SVR). With the introduction of ribavirin combination therapy and with pegylation of the IFN~     alfa molecule, however, response rates have improved dramatically, and current clinical trial~     data indicate that SVR rates between 43 and 79% are attainable in genotype 4 patients who are~     receiving pegylated IFN alfa plus ribavirin for 48 weeks. Clinical advances to optimize~     treatment for each patient have also been made, and tailored treatment options are now being~     developed that are comparable to the treatment approaches for genotype 1, 2, and 3 patients.~     A treatment duration of between 36 and 48 weeks appears to be optimal for most patients with~     chronic hepatitis C genotype 4.The aim of this study is to assess the efficacy and safety of~     pegylated interferon alpha 2a in patients with chronic hepatitis C genotype 4 in comparison~     to a historical cohort of patients treated with pegylated interferon alpha 2b~   "
233322|NCT00502086|"~     The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the~     mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal~     syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular~     carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison~     with placebo, during 96 weeks of treatment.~   "
233323|NCT00502073|"~     The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in~     the treatment of dry eye syndrome.~   "
233324|NCT00502060|"~     Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer~   "
233325|NCT00502047|"~     The hypothesis of this study is that soluble fibre may contribute to a reduction of the low~     density lipoprotein cholesterol (LDL-c), and the combined effect with a statin may achieve an~     optimisation of the cholesterol-lowering effects in adults with several cardiovascular risk~     factors.~   "
233326|NCT00502034|"~     The aim of this study is to compare the efficacy (in terms of event-free survival and overall~     survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see~     program in patient with radically operated renal cell carcinoma.~   "
233327|NCT00502021|"~     Preliminary studies have shown that flaxseed powder, rich in the omega-3 alpha-linolenic~     acid,is beneficial for the general inflammation present in morbidly obese subjects by~     decreasing elevated serum markers.As omega-3 fatty acids display additional properties~     including possible amelioration of atherosclerosis,a 3-month supplementation protocol was~     devised.Arterial stiffness and intima thickness will be measured in severely obese subjects,~     in order to document possible reduction of these variables as well.~   "
233328|NCT00502008|"~     The purpose of the study was to evaluate the effectiveness of Coccinia Cordifolia (synonym~     Coccinia indica) on the blood glucose levels of newly detected type 2 diabetic patients~     requiring only behavioral or lifestyle intervention. The hypothesis of the study is that~     there will be significant decrease in the blood glucose levels after a period of 90 days in~     the diabetic patients who consumed the coccinia extract.~   "
233329|NCT00501995|"~     Systemic Sclerosis (Scleroderma) varies greatly in clinical manifestations, mode of~     presentation, and course. The natural history of this chronic autoimmune disease ranges from~     benign to fatal. Patients are classified into limited and diffuse scleroderma defined by the~     degree of skin involvement. Patients with limited disease (e.g. the C.R.E.S.T. syndrome)~     generally have mild disease and normal survival. However, patients with diffuse cutaneous~     scleroderma often have severe multi-system disease that is not only devastating emotionally~     and physically but is associated with a 60-70% five year survival and a 40-50% 10 year~     survival. No therapies have proven effective in the treatment of scleroderma. Strategy to~     treat scleroderma have included attempts to prevent fibrosis with drugs that interfere with~     collagen metabolism, attempts to modify the disease process by immunosuppression and attempts~     to alter the disease by vasoactive drugs. High dose of corticosteroids and other~     immunosuppressive drugs (e.g. chlorambucil, 5-fluorouracil, methotrexate, cyclophosphamide,~     cyclosporine) used at conventional doses have not proven curative, but have shown some~     benefit for inflammatory features of the disease (e.g. arthritis, myositis, fibrosing~     alveolitis).~      Both allogeneic and autologous bone marrow transplantation (BMT) have shown to modify and in~     some instances reverse a variety of animal models of autoimmune disease. This has prompted~     many investigators to propose the use of peripheral blood stem cell transplantation (PBSCT)~     for the treatment of autoimmune disease including scleroderma. Unfortunately, this approach~     risks infusing untreated autoreactive lymphocyte clones after the immunoablative preparative~     regimen. We have previously demonstrated that high-dose cyclophosphamide without BMT can~     induce durable and complete remissions in another autoimmune disease, severe aplastic anemia.~     Recent data with high dose cyclophosphamide show that it can induce complete remissions in~     other autoimmune hematologic disorders. The objective of this study is to determine whether~     high dose cyclophosphamide can induce a durable remission in scleroderma patients with~     life-threatening disease, and to determine toxicity of high dose cyclophosphamide in high~     risk scleroderma patients.~   "
233330|NCT00501982|"~     The primary objective of this study is to compare two methods of post-delivery stabilization~     and subsequent early respiratory care for reducing the need for MV and related secondary~     complications, such as BPD, in premature babies at high risk of RDS:~        1. Early stabilization on nCPAP~        2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery,~          and rapid extubation to nCPAP.~      The data obtained from this comparison will be applied to test the hypothesis that preterm~     neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need~     for MV when compared to infants who receive nCPAP alone.~   "
233331|NCT00501969|"~     The objective of this open-label extension is to assess the safety and tolerability of~     long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic~     Parkinson's disease~   "
233332|NCT00501956|"~     Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of~     malnutrition in these patients is dietetic counseling, additional enteral nutrition and~     occasionally drug therapy.~      In cases where primary treatment of malnutrition is not effective, intradialytic parenteral~     nutrition (IDPN)during dialysis therapy may be administered. Using IDPN aminoacids,~     carbohydrates and fatty acids as well as vitamins and trace elements can be given to the~     patients.~      Effectiveness of IDPN has to be verified.~   "
234223|NCT00490113|"~     To determine whether pyridoxamine can decrease oxalate excretion in subjects who have normal~     oxalate excretion (but who have had kidney stones), and in subjects who have primary~     hyperoxaluria.~   "
233333|NCT00501943|"~     This is a double blind, randomized, parallel group design placebo-controlled mono-center~     study. Patients will be evaluated within twelve months of CIS onset. Patients with at least 2~     silent ovoid T2 bright areas in the deep white matter on their clinic brain MRI scan will be~     offered participation in the study. Patients will be randomized to oral riluzole or placebo~     (1:1). Patient will take 50 mg of riluzole or placebo once a day for one month. If 50 mg once~     a day is well tolerated, patients will then go on 50 mg twice daily for the rest of the~     study. They will start Avonex (Interferon beta 1a) therapy 30 mcg IM once weekly 3 months~     after study drug (riluzole or placebo) is initiated if their liver function has remained~     normal.~      Forty patients within twelve months of onset CIS onset will be enrolled at UCSF MS Center.~     Patients will be evaluated every month for the first 12 months and every three months~     thereafter for a total study duration of 24-month. Enrollment period will last six months.~   "
233334|NCT00501930|"~     This study will assess safety and tolerability when taking GSK189075 at doses that are likely~     to be higher than the expected prescribed doses. The study will also measure the level of~     GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests~     performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and~     will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo).~     Volunteers will not know which of the three doses they are receiving. In each period,~     volunteers will dose every morning for three straight days. Before and after dosing, blood~     pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs~     will be taken to assess safety. Volunteers will also be asked to provide information should~     they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in~     the blood will be assessed by multiple blood draws, most of these will follow the third dose~     in each period. Depending on the results from the preceding periods, a fourth period may be~     added to the study to assess another dose level. The fourth period, if this is to occur, will~     be the same design as the other three periods, and the dose received will be less than~     4000mg.~   "
233335|NCT00501917|"~     Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in~     patients with acute myocardial infarction who receive intracoronary infusion of mobilized~     peripheral blood stem cell in comparison with patient who treated with conventional measures~     and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF~     alone.~   "
233336|NCT00501904|"~     Metformin, an oral biguanide administrated for treating type-2 diabetes mellitus, is a safe~     and effective drug recently experimented also in patients with polycystic ovary syndrome~     (PCOS). The administration of metformin induces ovulatory cycles in CC-resistant or~     -nonresistant patients with PCOS, and improves the ovulation rate as an additional treatment~     in women who received CC.~      To date, it is unknown the best protocol for metformin administration. In particular, it is~     not known how long patients who ovulate under metformin should continue treatment before~     switching to second-line ovulation induction therapy. In this regard, in a recent study by~     the Kaplan-Meier survival analysis we demonstrated that the first pregnancy occurred late~     after metformin with an estimated median of seven months.~      Based on these considerations, the aim of the present study will be to evaluate the clinical~     efficacy of metformin according to its duration of administration in infertile PCOS patients~     ovulating under treatment.~   "
233337|NCT00501891|"~     This is a phase II study of the combination of Avastin and metronomic temozolomide in~     recurrent malignant glioma patients. The primary objective will be to determine the efficacy~     of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The~     secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in~     combination with metronomic temozolomide in terms of progression-free survival.~   "
233338|NCT00501878|"~     To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine~     for mydriasis in diabetic patient with darkly pigmented irides.~   "
233339|NCT00501865|"~     The rationale of this study is to assess whether or not food affects the absorption of~     GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or~     not this drug should be given at a certain time relative to the consumption of food.~   "
233340|NCT00501852|"~     This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients~     with stable COPD, in comparison to an active comparator.~   "
233341|NCT00501839|"~     Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS).~     Clomiphene citrate (CC) represents the first therapeutic option for treating the anovulatory~     infertility in PCOS patients because it is characterized by low costs, limited dose-dependent~     side effects, and simplicity of administration and management due to no need for ongoing~     monitoring.~      Excellent results in terms of ovulations have been obtained using CC. However, only 50% of~     patients who ovulates under CC will conceive. The exact explanation for the discrepancy~     between the ovulation and pregnancy rates is unknown, but several hypotheses on the~     anti-estrogenic effects that CC exerts on the ovary and uterus have been suggested.~      To date, few data are available on the optimal schedule for CC administration, and it is~     unknown how long patients who ovulate under CC should continue treatment before switching to~     second-line ovulation induction therapy. The aim of the study was to define the clinical~     benefits of CC administration according to its duration of administration.~   "
233342|NCT00501826|"~     The goal of this clinical research study is to learn the effectiveness of intensive~     chemotherapy given in combination with nelarabine (followed by maintenance therapy) in the~     treatment of patients with T cel ALL and T cell lymphoblastic lymphoma. The safety of this~     treatment will also be studied.~      This is an investigational study. All of the drugs used in this study are FDA approved and~     commercially available. Their use together in this study is investigational and for use in~     research only. Up to 100 patients will take part in this study. All will be enrolled at MD~     Anderson.~   "
233343|NCT00501813|"~     The purpose of this study is to compare the effects of different multimodality therapy~     strategies (initial hepatectomy followed by transcatheter hepatic arterial chemoembolization~     and/or local regional treatments compare with transcatheter hepatic arterial~     chemoembolization combined local regional treatments without hepatectomy)in the treatment of~     palliative resectable hepatocellular carcinoma with intrahepatic vessels invasion.~   "
248635|NCT00298311|"~     The objective of this study is to examine the impact of a home-based peer support~     intervention for mothers affected by postpartum depression (PPD) and for their infants.~   "
233344|NCT00501800|"~     The purpose of this study is to identify clinical and genetic markers of ovarian aging. In~     this process, we will evaluate environmental factors that may affect fertility and the age at~     which fertility declines, and may influence the age at which women enter menopause. Wide~     variability exists between women both in the age at which menopause occurs and the rate of~     decline in oocyte number and reproductive capability. As the loss of ovarian function has~     profound impact on women's hormonal milieu and their subsequent risk for the development of~     disease, improving our understanding of the factors that determine the timing and rate of~     reproductive aging is critical to improving quality of life for all women. In addition,~     improving our understanding of reproductive aging has profound economic, and social,~     implications given the complex choices women face regarding the timing of childbearing and~     the growing burden of infertility. While the inter-individual variability in age at menopause~     has a large genetic component and possible environmental influences, to date no studies have~     addressed the relationship between oocyte number as reflected by antral follicle count (AFC)~     and genetic inheritance.~      We hypothesize that ovarian aging, as reflected by antral follicle count, is largely~     determined by common genetic polymorphisms that impact the initial oocyte endowment and/or~     the rate of oocyte loss over time thus lowering antral follicle count for any given age. We~     further hypothesize that antral follicle count will be an improved marker of ovarian aging.~     Thus, we propose a study of the genetic and environmental factors that influence age-specific~     variability in antral follicle count.~   "
233345|NCT00501787|"~     In a recent prospective study evaluating the efficacy of 1700 mg/day metformin as first-line~     approach for infertile anovulatory patients with PCOS, we identified predictors for metformin~     efficacy. Our analysis demonstrated that body mass index (BMI) and insulin resistance were~     the strongest predictors for both ovulation and pregnancy. In particular, adjusting the data~     for insulin resistance, a trend in reduced effectiveness was observed with increasing BMI. On~     the other hand, adjusting the data for BMI, a trend in improved efficacy was detected for~     higher insulin resistance degrees.~      To date, no dose-finding study is currently available in literature evaluating the best dose~     of metformin to administer. In addition, very few data regarding the best protocol for~     metformin treatment also are available. However, in order to reduce drug-related side effects~     incidence due to start-up syndrome, metformin is generally administrated with meals at~     incremental weekly doses until the maximum dosage ranging from 500 to 2550 mg daily; the~     doses are reduced if side effects appear. This commonly accepted protocol has not been~     supported by scientific evidences.~      The aim of the present study will be to evaluate in a clinical setting the compliance, the~     safety and the effectiveness of two schedules for metformin administration in infertile~     anovulatory PCOS patients.~   "
233346|NCT00501774|"~     Hypothesis: to examine a possible association between localized vulvodynia and H. pylori~     infection.~   "
233347|NCT00501761|"~     Researchers propose to apply Social Cognitive Theory to improve understanding of the~     mechanisms of physical activity adherence for endometrial cancer survivors participating in a~     physical activity intervention.~      The specific aims of the study are:~        1. To test a Social Cognitive Theory-based model of physical activity adoption among~          sedentary endometrial cancer survivors receiving an intervention to increase physical~          activity. The model includes hypotheses about the effect of self-efficacy and outcome~          expectations on physical activity adherence, the effects of four sources of efficacy~          information (mastery experience, verbal persuasion, modeling, and physiological~          feedback) on self-efficacy and subsequent exercise adherence, and the influence of~          physical activity outcomes on subsequent self-efficacy, outcome expectations, and~          physical activity.~        2. To elucidate the influence on self-efficacy of cardiorespiratory fitness and somatic~          sensations while engaging in physical activity.~        3. To determine whether the received dose of an intervention based on Social Cognitive~          Theory is related to physical activity adherence.~        4. To test the effects of adherence to physical activity on endometrial cancer survivors'~          quality of life and stress as assessed by self-report and salivary cortisol.~        5. To test the feasibility of a web-based maintenance intervention for women who have~          completed the phone counseling portion of the study.~   "
233348|NCT00501748|"~     The goal of this research study is to investigate whether Rituximab is safe to use in~     patients suffering from NMO, or who are at high risk for developing NMO. It is thought that~     NMO is caused by the immune system reacting against the optic nerves and spinal cord. B cells~     are a part of the immune system that may contribute to the illness. Rituximab is an antibody~     that depletes B cells. Depletion of these B cells with Rituximab may induce remission of the~     disease. Because pathological and serological studies suggest that NMO appears to be, at~     least in part, a B-cell mediated disease Rituximab, is an attractive treatment candidate for~     this disease.~   "
233349|NCT00501735|"~     This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up~     to 50 sites in North America, Europe and Australia. This study is designed to assess~     objective response (OR) [complete response (CR) or partial response (PR)] in subjects with~     cutaneous manifestations of CTCL with a requirement for maintenance of such objective~     response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally,~     this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB,~     III, or IVA treated with oral forodesine.~   "
233350|NCT00501722|"~     The primary objective is to determine the optimal dose or range of doses of SR121463B for the~     treatment of ascites and the correction of hyponatraemia when used concomitantly with a~     standard dose regimen of spironolactone.~      The secondary objective is to determine the tolerability of different fixed doses of~     SR121463B over a 14 day treatment period in cirrhotic ascites.~      This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term~     safety extension (Expo~CAT). The first extension is followed by another long-term study~     (PASCCAL-1).~   "
233351|NCT00501709|"~     Pancreatic islets are the part of the pancreas that produce insulin and help control the~     blood sugar. This study aims to improve islet transplantation as a treatment for Type 1~     Diabetes by using a new combination of immunosuppressive drugs that have been successful in~     treating other autoimmune diseases and in preventing kidney transplant rejection.~   "
233501|NCT00499720|"~     The primary objective of this program is to provide expanded access to aztreonam lysine for~     inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis~     (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at~     risk for disease progression.~   "
233352|NCT00501696|"~     This is a randomized placebo-controlled, parallel-group study, crossover-design of the~     effects of low dose naltrexone on the multiple sclerosis quality of life inventory (MSQLI54)~      This study will assess the impact of LDN compared to placebo on quality of life as measured~     by the composite score of the MSQOL54 in adult subjects with MS.~      Also we plan:~        1. To compare the 10 scales of the MSQOL54 during the active treatment and placebo cycles~          between active treatment and placebo groups~        2. To compare each individual's composite response to LDN versus placebo during the active~          treatment and placebo cycles~        3. To compare each individual on the 10 scales of the MSQOL54 during the active treatment~          and placebo cycles~   "
233353|NCT00501683|"~     This study will look at the relative amounts of GSK189075 that are found in samples of blood,~     urine, and feces of healthy male volunteers. Results of the study will be used to understand~     how the drug is converted in the body and how it is eliminated.~   "
233354|NCT00501670|"~     This study will evaluate and compare various methods for collecting lesion samples from~     subjects with clinically diagnosed herpes zoster for the laboratory confirmation of herpes~     zoster. The samples will be tested by polymerase chain reaction (PCR) to detect VZV DNA.~     Multiple samples from each type of herpes zoster lesion will be collected in order to~     determine whether the analysis of duplicate samples enhances the sensitivity of VZV DNA~     detection for the diagnosis of herpes zoster. In addition, blood will be collected for the~     evaluation of VZV immunity at the time of the initial herpes zoster sample collection (after~     herpes zoster has been clinically diagnosed) and one month later in order to establish the~     range of cellular and humoral immune responses during natural herpes zoster in adults ≥50~     years old.~   "
233355|NCT00501657|"~     The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate~     at which the stomach empties, and the release of gut hormones and blood glucose~     concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to~     reduce the blood glucose (sugar) response to a meal and this may potentially be due to~     slowing of stomach emptying. This is particularly relevant to people who have diabetes, in~     whom normalization of elevated blood glucose levels is important to maintain health.~   "
233356|NCT00501644|"~     Primary Objectives:~        1. Determine response rate, time to progression, and toxicity of a schedule of carboplatin~          by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in~          patients with potentially platinum-sensitive recurrent Müllerian carcinomas.~        2. Determine whether this treatment schedule is associated with:~             1. increased levels of monocytes (>2-fold and absolute numbers 1000 cells/ml,) and of~               LN-DR+ DC (CD11c+ and CD123+ subsets)~             2. induction of priming and activation of MO/MA (monocytes/ macrophages), and~               maturation of DC (dendritic cells).~        3. Determine the toxicity profile of consolidation treatment with IP (intraperitoneal)~          injections of rIFN-g added to carboplatin (IV) and GM-CSF (SC) for 4 doses/course.~        4. Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in~          patients with platinum-sensitive Müllerian carcinomas.~        5. To begin an exploration of cell surface proteins on purified activated peripheral blood~          and ascites monocyte/macrophages both before and after treatment with GM-CSFand rIFN-g.~   "
233357|NCT00501631|"~     VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to~     abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.~     This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus~     placebo. Injections were administered to patients in whom abstinence was enforced by a period~     of inpatient hospitalization of 7 to 21 days.~   "
233358|NCT00501618|"~     The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo~     (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and~     such data is important for clinicians to have.~   "
233359|NCT00501605|"~     Single centre recruiting approximately 80 patients who are given a rising single, followed by~     multiple, ascending oral dose of AZD2171, assessing the safety and tolerability of AZD2171 in~     patients with solid tumors and metastatic liver disease.~   "
233360|NCT00501592|"~     The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus~     (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:~        -  The safety and tolerability of multiple doses of INT 747;~        -  The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and~          glucose homeostasis;~        -  Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes~          and biochemical markers of hepatic and metabolic function and inflammation, and;~        -  Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic~          acid (6-EDCA) and tauro 6-ECDCA.~   "
233361|NCT00501579|"~     The purpose of this study is to determine the safety and efficacy of difluprednate compared~     with prednisolone acetate in the treatment of endogenous anterior uveitis.~   "
233362|NCT00501566|"~     The primary objective is to determine the optimal dose or range of doses of SR121463B for the~     treatment of ascites when used concomitantly with a standard dose regimen of spironolactone~     and furosemide.~      The secondary objective is to determine the tolerability of different fixed doses of~     SR121463B over a 14 day treatment period in cirrhotic ascites.~   "
233363|NCT00501553|"~     To investigate the prevalence of vitamin D deficiency in patients with Heart Failure.~      To investigate if vitamin D levels are correlated to the degree of Heart Failure.~   "
233364|NCT00501540|"~     The purpose of this study is to learn more about the effectiveness and side effects of~     lithium treatment for subjects with low-grade neuroendocrine tumors.~   "
233365|NCT00501527|"~     The objective of this trial is to evaluate the clinical effectiveness of the administration~     of a depigmented and polymerized allergen extract of Phleum pratense in the~     rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass~     pollen.~   "
233366|NCT00501514|"~     The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity~     and cardiopulmonary performance in patients with chronic heart failure.~   "
233367|NCT00501501|"~     Hypothesis: The rates of rehospitalization after cesarean section are significantly higher~     than those following spontaneous vaginal delivery and are due mainly to late bleeding and~     less to infection.~   "
233368|NCT00501488|"~     The aims of the present study were to investigate the association between adiponectin gene~     polymorphisms and the response to rosiglitazone monotherapy in T2D patients.~      A total of 255 T2D patients and 120 health volunteers were enrolled in this study. 42 T2D~     patients with -11377(C/G) or +45(T/G) genotypes were selected to administrate orally 4mg~     rosiglitazone daily for 12 consecutive weeks.~   "
233369|NCT00501475|"~     The purpose of this study is to evaluate the effect of NAC or sodium bicarbonate in~     preventing the aggravation of renal function in chronic renal failure when enhanced computed~     tomography scan is checked in emergency room.~   "
233370|NCT00501462|"~     This is an open-label study that will measure blood levels of different parts of a drug~     called GKS189075. People participating in this study will receive a single dose of 250mg~     GSK189075 by mouth. About 20 people with mild to moderate decrease in renal (kidney) function~     will be asked to participate in this study. They will be compared to about 20 healthy~     participants who are close to the same age and body size. People participating in this study~     will stay at a clinical research unit beginning 2 days before they receive their single dose~     of GSK189075 and will remain there until approximately one day after receiving the study~     drug. During this study urine will be collected beginning the day before receiving study drug~     until the day after, just prior to leaving the clinical research unit. Blood samples will~     also be collected at various times beginning immediately before until 24 hours after~     receiving the study drug.~   "
233371|NCT00501449|"~     The specific aims of the study include:~        1. Profile the demographic, health-related, psychosocial and behavioral characteristics of~          adults with MEN1 or MEN2.~        2. Evaluate MEN-specific distress as well as adherence to surveillance regimens among~          adults with MEN1 or MEN2, and identify associated with those outcomes.~   "
233372|NCT00501423|"~     The ADRIE study is an observational study on the clinical relevance of platelet reactivity in~     aspirin and clopidogrel treated cardiovascular patients.~   "
233373|NCT00501410|"~     The goal of the Phase I part of this clinical research study is to find the highest tolerable~     dose of a combination of dasatinib, cetuximab, and FOLFOX (5-fluorouracil [5-FU], leucovorin~     [LV], and Eloxatin [oxaliplatin]) that can be given to patients with metastatic colorectal~     cancer. The safety of these drugs in combination will also be studied.~      The goal of the Phase II part of this clinical research study is to learn if dasatinib given~     in combination with FOLFOX with or without cetuximab can help to control metastatic~     colorectal cancer.~   "
233374|NCT00501397|"~     The purpose of this research study is to evaluate the effect of several daily doses of~     ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single~     dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and~     tolerability of GSK189075 in healthy volunteers. The study will see whether ketoconazole~     causes GSK189075 to stay in your bloodstream for a longer period of time. It will also~     examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.~   "
233375|NCT00501384|"~     The primary objective is to determine the optimal dose or range of doses of SR121463B for the~     reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of~     spironolactone.~      The secondary objective was to determine the tolerability of different fixed doses of~     SR121463B in cirrhotic ascites, over a 12-week treatment period.~      This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety~     extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).~   "
233376|NCT00501371|"~     Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS~     (30mg/day) vs. placebo.~      Subproject MCS-2: alpha-blocker naïve subjects~      Subproject MCS-3: subjects responding poorly to alpha-blocker~   "
233377|NCT00501358|"~     There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS),~     which could play a role in the increased cardiovascular morbility and mortality. Respiratory~     alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients~     suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be~     a risk factor for venous thromboembolism (VTE).~      OBJECTIVES:To calculate and compare the prevalence of sleep apnea-hipopnea syndrome in~     patients with venous thromboembolism with a gender, aged and BMI matched control group.~     Assessment of the association between SAHS and other risk factors for VTE. To compare~     clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial~     obstruction index in patients with SAHS and VTE and those ones without SAHS.~   "
233378|NCT00501345|"~     Primary Objective:~      To determine the risk of bleeding from ASA therapy in thrombocytopenic patients who develop~     Acute Coronary Syndrome (ACS), and assess its effect on the overall morbidity and mortality~     in these patients as well as platelet functions.~   "
233379|NCT00501332|"~     This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients~     treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle~     of chemotherapy, for a planned total of six chemotherapy cycles.~   "
233380|NCT00501319|"~     Primary Objectives:~        -  To longitudinally assess the natural history of symptoms (prevalence, severity, patterns~          of symptoms, and the relationship of physical and psychological distress) among~          post-thoracic surgery for non-small cell lung cancer patients with early stage (stage~          I-IIIA) disease.~        -  To determine crisis events (when symptoms are most severe), their relationship with~          cancer therapy, surgical techniques and disease, and their relationship with function~          and quality of life; and to determine current practice patterns of symptom control~          throughout the six months of the post-surgical phase.~        -  To determine the utility of a weekly, telephone-administered interactive voice response~          symptom assessment (IVR-MDASI) for identifying emergent clinically significant symptoms~          in this population.~        -  To develop symptom severity critical values and critical treatment algorithms for~          post-operative symptom control for NSCLC patients.~   "
233416|NCT00500851|"~     The purpose of this study is the evaluation of the success rate of jejunal tube placement~     comparing the endoscopic versus the electromagnetic method in a comparative ICU patient~     population. The investigators hypothesized that success rate of the electromagnetic jejunal~     tube placement will be lower than the success rate of the endoscopic method.~   "
233417|NCT00500838|"~     The intent of this feasibility study is to collect and analyze intra-thoracic impedance~     measurements from a CRT-D device in a heart failure population.~   "
233381|NCT00501306|"~     This study is designed to identify barriers that prevent men who have sex with men from~     receiving doctor-recommended annual follow-up screenings for anal cancer. Men who are at the~     highest risk for developing anal cancer will be asked to complete a brief questionnaire~     (either via telephone or in writing). The questionnaire is designed to identify potential~     barriers to care-seeking behavior including, relationship status, financial constraints,~     highest level of education and knowledge about anal cancer and its precursors. The men who~     agree to participate in the study will then be organized into groups based on their history~     of coming in for follow-up screening visits after learning that they are at higher risk for~     developing anal cancer. These groups include 1) men that have come in for regular screening~     visits (at least once per year), 2) men who came in once and were then lost to follow-up, 3)~     men who came in for more than one screening visit and were then lost to follow-up, and 4) men~     who were previously lost to follow-up and then began coming in for screening again. By~     comparing the men's responses across the different groups, we hope to uncover key barriers~     and drivers to follow-up screenings for anal cancer.~      The goal of this study is to evaluate the differences in questionnaire responses across~     cohorts that may impact care-seeking behavior.~      We hypothesize that:~        -  Patients who regularly comply with annual follow-up screening visits score higher on~          questions assessing knowledge of HPV and anal cancer.~        -  Men in stable relationships are more likely to comply with annual screening visit~          recommendations.~        -  Men who are educated by their primary care physicians about the importance of anal~          cancer screenings have higher screening rates.~   "
233382|NCT00501293|"~     To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17~     years diagnosed withADHD~   "
233383|NCT00501280|"~     Primary Objectives:~        1. To test the hypothesis that children whose mothers are Migrant/Seasonal Farmworkers~          (MSFs) (occupationally-exposed to pesticides) may be at a higher risk for exhibiting~          mutagen-induced DNA damage than children whose mothers and fathers are not MSFs.~        2. To test the hypothesis that MSF mothers (occupationally-exposed to pesticides) may be at~          a higher risk for exhibiting mutagen-induced DNA damage than mothers who are not MSFs.~      Secondary Objectives:~        1. To test the hypothesis that both the extent of pesticide exposure and the type of~          polymorphisms in chemical detoxification genes and DNA repair genes contribute to the~          extent of cytogenetic damage found in children of MSF women.~        2. To test the hypothesis that both the extent of pesticide exposure and the type of~          polymorphisms in chemical detoxification genes and DNA repair genes contribute to the~          extent of cytogenetic damage found in MSF mothers.~        3. To test the hypothesis that the total concentration levels of organochlorine (OCP) and~          organophosphate (OP) pesticides will correlate with the mutagenic potency of the serum~          and urine of the children.~        4. To test the hypothesis that the total concentration levels of OCP and OP pesticides will~          correlate with the mutagenic potency of the serum and urine of the mothers.~        5. To test the hypothesis that inherited polymorphisms in the PON1 gene and its expression~          modulate the risk for OP genotoxicity measured by the inhibition of the~          acetylcholinesterase enzyme in MSF children.~        6. To test the hypothesis that inherited polymorphisms in the PON1 gene and its expression~          modulate the risk for OP genotoxicity measured by the inhibition of the~          acetylcholinesterase enzyme in MSF mothers.~   "
233384|NCT00501267|"~     The purpose of this study is to determine the effect of repeat doses of solabegron and~     oxybutynin when taken alone or together~   "
233385|NCT00501254|"~     Evaluation of the pharmacodynamic profile (antiaggregant profile, balance of prostanoids and~     nitric oxid) of a ASA-SR (slow-release)formulation in comparison with a ASA NR (normal~     release), 150 mg, during 12 months of treatment.~   "
233386|NCT00501241|"~     The purpose of this study is to determine whether ATI-7505 is effective in the treatment of~     chronic idiopathic constipation.~   "
233387|NCT00501228|"~     Primary Objective:~      1. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells~     contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue~     caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell~     transplantation.~      Secondary Objective:~      1. To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to~     epithelial/endothelial or solid organ-specific tissue.~   "
233388|NCT00501215|"~     Primary hyperparathyroidism (PHPT) is an endocrine disorder that disrupts calcium metabolism~     and has a broad range of clinical manifestations. With respect to the nonclassic, subjective~     symptoms that have been reported to be associated with PHPT, such as sleep disturbance,~     neurocognitive dysfunction, mood disturbance, fatigue, and decreased quality of life, there~     is a lack of objective data on the extent to which these symptoms are affected by~     parathyroidectomy.~      There have been reports of improvements in sleep in patients following parathyroidectomy, but~     these have been based solely on subjective sleep surveys. To date, there are no published~     studies on objective sleep evaluations of patients with PHPT. The overall goals of this~     protocol are to ascertain the feasibility of performing sleep studies on patients with PHPT,~     and to obtain pilot data on the effects of parathyroidectomy on those sleep studies.~      It is hypothesized that it will be feasible to evaluate sleep parameters in patients with~     PHPT in the M. D. Anderson Sleep Center. Towards testing this hypothesis, the specific aims~     are:~      Specific Aim 1: To assess the feasibility of using nocturnal polysomnography (PSG) to~     evaluate the primary outcome measure of total sleep time.~      Specific Aim 2: To assess the feasibility of using nocturnal polysomnography (PSG) to~     evaluate the secondary outcome measures of sleep architecture, arousal index, sleep~     efficiency, wake after sleep onset, and sleep onset latency in patients with PHPT.~      Specific Aim 3: To assess the feasibility of evaluating the secondary outcome measures of~     subjective sleepiness as tested with the Epworth Sleepiness Scale (ESS), and of sleep quality~     as tested with the Brief Sleep Disturbance Scale (BSDS) in patients with PHPT.~      Specific Aim 4: To assess the feasibility using a randomized wait-list-control design to~     assess the effects of parathyroidectomy on sleep measures obtained with nocturnal PSG.~   "
233389|NCT00501202|"~     The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200~     mg of RWJ-333369 given twice daily by mouth compared with placebo in the treatment of~     Diabetic Peripheral Neuropathy (DPN).~   "
233390|NCT00501189|"~     This project will compare the rate of regression of minimally abnormal Pap smears to normal~     in women who receive Gardasil to a historical control group.~      Research hypothesis: Women with low grade cervical dysplasia on Papanicolaou (Pap) smear that~     receive Gardasil vaccination will revert to a normal within one year at a rate 33% higher~     than historical controls that did not receive Gardasil vaccination.~   "
233391|NCT00501176|"~     Randomized study comparing the effect of plastic stents to that of expandable metal stents as~     pre-operative drainage of the bile ducts prior to Whipple operation.~   "
233418|NCT00500825|"~     The purpose of this study is the evaluation of the influence of therapeutic hypothermia on~     resting energy expenditure (REE) in patients after cardiopulmonary resuscitation (CPR). We~     hypothesized that hypothermia would reduce resting energy expenditure in these patients.~   "
233392|NCT00501163|"~     Participants will be asked to do the following:~        1. A screening session in which you will take part in a diagnostic interview that will take~          about 2-3 hours to complete and will address your medical history. If you've recently~          participated in one of Dr. Haupt's or Dr. Newcomer's studies (HRPO #03-1281, 01-0134, or~          04-0191) you may not have to complete this screening interview.~        2. An ultrasound test of your heart and blood vessels where an ultrasound machine will use~          sound waves to create images that allow the main blood vessels in your neck to be~          examined. You will be lying down for the procedure, and a colorless gel will be applied~          to the side of your neck where the handheld probe (called a transducer) will be placed.~          The transducer will then be gently moved over each side of your neck. This procedure~          will take approximately 30 minutes.~        3. A magnetic resonance image (MRI) study where the amount of fat in your liver will be~          measured. The MRI involves having your body painlessly scanned inside a tubular machine,~          while lying on a table for about 45 minutes.~        4. Some routine blood tests to assess glucose (sugar) and lipid (fat) control and liver~          function, as well as an additional hepatitis screen if you have a history of hepatitis.~          You will go to the Intensive Research Unit (IRU) or Clinical Trials Unit (CTU) after an~          8 to 10-hour overnight fast (except water). Approximately 42 ml (3 tablespoons) of blood~          will be obtained from you, and you will also have your height, weight, blood pressure,~          and waist and hip measurements taken. This will take approximately one hour.~        5. A dual energy x-ray absorptiometry (DEXA) scan to measure your body fat and body muscle~          content. The DEXA scan involves lying on a table in a private room wearing a hospital~          gown for about 15 minutes while a machine silently measures the amount of fat in your~          body. The DEXA scan is part of the research study and gives the researcher a picture of~          how much fat is in your body.~   "
233393|NCT00501150|"~     The main purpose of this study is to find out whether changing the hospital policy to allow~     switch from glycopeptide antibiotics (given by intravenous drip), to an equally effective~     oral antibiotic (linezolid) will enable patients who are otherwise well enough to be~     discharged from hospital sooner.~      The secondary objectives are~        1. To identify those patients who could potentially be discharged on an oral agent from~          those being treated with a glycopeptide, thus helping target this approach most~          effectively~        2. To evaluate the cost involved and compare this with the costs that would have taken~          place if use of an oral agent and discharge had not occurred.~   "
233394|NCT00501137|"~     Primary objective is to determine if antibody responses to HPV types 16 & 18 are non-inferior~     after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination,~     with responses measured at Month 7.~   "
233395|NCT00501124|"~     A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period.~     Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks~     followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this~     study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine~     alone in patients with chronic hepatitis B infection.~   "
233396|NCT00501111|"~     The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with~     mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to~     define the optimal dose(s) to be used in future trials.~   "
233397|NCT00501098|"~     -  To assess the overall clinical yield - in terms of efficacy and safety endpoints of~          adding caspofungin as prophylaxis of Invasive Pulmonary Aspergillosis in patients~          undergoing induction treatment for newly diagnosed acute leukemia~        -  To investigate the prognostic significance of Ptx3 at diagnosis and during the first~          chemotherapy cycle with respect to the development of IPA~   "
233398|NCT00501085|"~     The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.~   "
233399|NCT00501072|"~     To investigate the effectiveness and safety of a Real Time Continuous Glucose Monitoring~     System (RT-CGMS in a population of patients with type 1 diabetes mellitus treated with~     insulin through an implanted pump.~   "
233400|NCT00501059|"~     The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been~     extensively studied but to a lesser extent in patients with moderate levels of cardiovascular~     risk. The current study is designed to prove the efficacy and tolerability of 100 mg~     enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD)~     events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and~     CV death, in a population with no history of known CVD who are at moderate risk of major CHD~     events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean~     10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and~     may receive treatment for the underlying risk factors as defined by the treating physician.~     Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will~     be monitored by an independent Data Safety Monitoring Board.~   "
233401|NCT00501046|"~     1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to~     standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first~     occurrence of any event of the triple composite outcome of initiation of dialysis, kidney~     transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate~     the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate~     the effects of AST-120 versus placebo, on other measures of renal function and quality of~     life.~   "
233402|NCT00501033|"~     Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging~     obstetrical process, and may be influenced or complicated by the cervical ripening method~     used. We will conduct a comparative study of the foley catheter vs the cervical ripening~     double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean~     section rate, infections and postpartum complications, especially endometritis.~   "
233403|NCT00501020|"~     This was a randomized, double-blind, double dummy, multicenter study to assess the safety,~     efficacy and tolerability of the addition of RSG (rosiglitazone) to sub-maximal MET~     (metformin) combination relative to maximal MET monotherapy in subjects with type 2 DM~     (diabetes mellitus). The total duration of the study was approximately 20 months. The study~     consisted of a two-week washout period, a four to seven-week MET titration period, and a~     24-week randomized treatment phase in which subjects, stratified by prior therapy, received~     either RSG + MET combination therapy or MET monotherapy.~   "
233404|NCT00501007|"~     The primary purpose of this investigation is to determine the predictive value of task~     persistence as measured by a mirror tracing task. A secondary purpose is to evaluate~     differences in task persistence in smokers with or without schizophrenia. It is hypothesized~     that task persistence in smokers in both diagnostic categories (schizophrenia and no~     schizophrenia) will predict tobacco dependence treatment outcome at one and six months. It is~     also hypothesized that smokers with schizophrenia will show lower levels of task persistence~     after controlling for other motor skills than smokers without schizophrenia.~   "
233405|NCT00500994|"~     This study is part of a series of studies that will explore how the mind and the brain work~     to cause episodes of uncontrollable shaking in people who have no known underlying brain or~     medical disorder. The study is conducted at NIH and at the Brown University Rhode Island~     Hospital.~      Healthy volunteers and people with psychogenic movement disorders (PMD) or non-epileptic~     seizures (NES) who are 18 years of age or older may be eligible for this study.~      Patients with NES have 3 teaspoons of blood drawn. The blood is tested for two genes that are~     normally found in healthy individuals to see if they are found more frequently in patients~     with uncontrolled shaking.~      Patients with PMD have blood drawn for testing and also undergo functional magnetic resonance~     imaging (fMRI) to look at how the brain functions while the subject performs a specific task.~     MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues.~     During the scan, the subject lies on a table that can slide in and out of the scanner, a~     metal cylinder. The scan lasts about 60 to 90 minutes, during which the subject may be asked~     to lie still for up to 10 minutes at a time and to perform tasks, such as identifying the~     gender of faces shown on a screen.~      Healthy volunteers may have blood drawn for genetic testing or fMRI or both.~   "
233406|NCT00500981|"~     The goal of this study is to evaluate whether measures of the size of the internal jugular~     vein have clinical utility in predicting whether patients may benefit from treatment with~     intravenous fluid.~   "
233407|NCT00500968|"~     Randomized study assessing the effect of transpapillary pancreas duct stent in resection of~     the pancreatic tail.~   "
233408|NCT00500955|"~     Following a 4-week single-blind placebo run-in period, eligible subjects were randomized in a~     1:1 ratio to receive 32 weeks of double-blind study medication: Rosiglitazone (starting dose~     4mg od) or Glyburide (starting dose 5mg od), both in combination with open-label Metformin >~     or = (1g/day). Subjects were stratified for use of ACEI, nondihydropyridine calcium channel~     blockers (NDP CCB), or angiotensin II receptor blockers (ARB) to provide equal representation~     of these subjects in each treatment group.~   "
233409|NCT00500942|"~     Primary Objectives:~        -  To measure and record patients' pain levels before, during, and after standard~          procedures performed in IR.~        -  To compare different procedures to respective pain levels and patient satisfaction (as~          determined by questionnaire).~   "
233410|NCT00500929|"~     To provide information on parameters needed to design a subsequent Phase III confirmatory~     trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk~     geriatric patients undergoing open-heart surgical procedures (OHSP) requiring~     cardio-pulmonary bypass.~   "
233411|NCT00500916|"~     The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff~     to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The~     manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA,~     or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of~     insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100)~     respectively, with the main causes of insertion difficulty being impaction at the back of the~     mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an~     insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB)~     placed in the esophagus to guide the PLMA around the back of the mouth and into its correct~     position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive~     insertions. In the following study, we test the hypothesis that GEB-guided insertion is more~     frequently successful than the digital and IT techniques in patients with difficult airway.~   "
233412|NCT00500903|"~     To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of MLN8237~     when given by mouth (PO) for a minimum of 7 and a maximum of 21 consecutive days, followed by~     a 14-day recovery period.~   "
233413|NCT00500890|"~     The goal of this clinical research study is to compare carboplatin to cyclophosphamide when~     given with etoposide, vincristine, and radiation therapy in the treatment of choroid plexus~     tumors. The safety of these 2 combination therapies will also be compared.~      Objectives:~      OVERALL AIM:~      To improve choroid plexus tumor treatment through better understanding of the tumor biology~     and through increased knowledge about the benefit of specific treatment elements.~      Specific Objectives:~      The study will have a prephase to evaluate the feasibility of the following randomized study~     (main phase).~      Pre-Phase (completed 2005) Primary Specific Objective:~      To determine the number of patients accountable per year for randomization in a worldwide~     study.~      Secondary Specific Objective:~      To measure the number of drop outs and to describe the toxicity of the chemotherapy.~      Main Phase (started in 2006) Primary Specific Objective:~      To compare the survival times after cyclophosphamide based treatment with the survival times~     after carboplatin based treatment in choroid plexus tumor patients.~      Main Phase Secondary Specific Objectives:~        1. To compare the resectability of choroid plexus tumors after two blocks of~          cyclophosphamide based treatment with the resectability after two blocks of carboplatin~          based treatment.~        2. To compare response rates of incompletely resected choroid plexus tumors to two blocks~          of cyclophosphamide based treatment with the response rates after two blocks of~          carboplatin based treatment.~        3. To determine the prognostic relevance of histological atypia and SV40 in choroid plexus~          tumors.~   "
233414|NCT00500877|"~     Information obtained from this study will help us to have a better idea of how phone~     counseling may facilitate the process of quitting smoking for individuals with a history of~     recurrent depression.~   "
233415|NCT00500864|"~     Dietary magnesium (Mg) intake has been shown to be independently related to lung function,~     airway reactivity, and respiratory symptoms in the general population. Inhaled Mg and IV Mg~     administration have been shown to promote bronchodilation and to improve lung function in~     asthmatic patients. Some studies have suggested that COPD patients exhibit decreased body~     levels of Mg. The purpose of the present study was to investigate the effects of acute IV Mg~     loading on parameters of respiratory function and maximal exercise capacity of stable COPD~     patients.The study hypothesis is that Mg administration will be associated to improvements on~     airflow and vasodilation leading to improvements of pulmonary function and exercise~     performance.~   "
233452|NCT00500370|"~     This is a multicenter study designed to compare the effect of exenatide plus a lifestyle~     modification plan versus placebo plus a lifestyle modification plan on weight loss in~     non-diabetic, obese subjects.~   "
233419|NCT00500812|"~     This trial is a multi-center, open-label, dose-escalation study designed to evaluate the~     safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury~     patients: those with a complete cervical injury or a complete thoracic injury. Dose levels~     from 0.3 mg - 9 mg of Cethrin will be administered.~   "
233420|NCT00500799|"~     This study will examine the role of certain areas of the brain in blepharospasm, a type of~     dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable~     blinking or closing of the eyelids. The study will compare brain activity in healthy~     volunteers and in people with blepharospasm to find differences in the brain that may lead to~     better treatments for dystonia.~      Healthy volunteers and people with blepharospasm who are 18 years of age and older may be~     eligible for this study. All candidates are screened with a medical history. People with~     blepharospasm also have a physical examination and blepharospasm rating.~      Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in~     two 4-hour sessions, separated by 1 to 7 days.~      TMS~      A wire coil is held on the subject's scalp. A brief electrical current is passed through the~     coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may~     feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the~     face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles~     slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses~     delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes.~      EMG~      Surface EMG is done during TMS to measure the electrical activity of muscles. For this test,~     electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the~     face....~   "
233421|NCT00500786|"~     This is a multi-center, randomized, placebo-controlled, time-lagged, parallel-group study in~     healthy and hypertensive subjects to evaluate safety and tolerability of the vaccine~     CYT006-AngQb. The trial is double-blind for active vs. placebo within each treatment arm, but~     open with respect to AngQb dose escalation.~      In the first arm, 16 healthy normotensive volunteers are treated with a one dose regimen~     consisting of a single s.c. injection of 100µg of AngQb or placebo. Upon satisfying safety~     and tolerability profile, as judged by the independent safety monitoring board, arm two is~     enrolled.~      In arm two 36 patients with mild to moderate hypertension receive three s.c. injections of~     100µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections~     are given 4 and 12 weeks after the first injection, respectively. Upon satisfying safety and~     tolerability profile, as judged by the independent safety monitoring board, arm three is~     enrolled.~      In arm three 36 patients with mild to moderate hypertension receive three s.c. injections of~     300µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections~     are given 4 and 12 weeks after the first injection, respectively.~      The primary objective of the trial is to evaluate safety / tolerability of 3 dose regimens of~     CYT006-AngQb in healthy volunteers and patients with mild to moderate essential hypertension.~     Secondary objectives include the assessment of pharmacodynamic effects and their~     dose-response (immunogenicity and biomarkers of the renin-angiotensin system), and the~     exploration of clinical efficacy (effects on systolic and diastolic blood pressure)~   "
233422|NCT00500773|"~     The purpose of this study is to determine the cardiovascular risk involved in the exertional~     exercise of marathon running. The researchers aim to investigate the beneficial effects of~     regular well-dosed exercise on health and compare these findings with the effects of the~     extreme strains of marathon running. Subclinical injuries to heart and arteries are being~     investigated in different groups of runners, including obese participants.~   "
233423|NCT00500760|"~     The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for~     patients with locally advanced squamous cell carcinoma of the head and neck but additional~     improvements to treatment regimens are needed. The study is investigating if the addition of~     a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding~     unmanageable toxicity.~   "
233424|NCT00500747|"~     The purposes of this study are to evaluate the safety, tolerability, and effectiveness of a~     vaccine (the HCV E1/E2/MF59 vaccine) against hepatitis C (HCV). The vaccine will be given to~     60 healthy adult volunteers (aged 18-45 years) and the study will compare the immune system~     (the body's protective response) response to the HCV E1/E2 vaccine given at different dosage~     levels: 4 micrograms, 20 micrograms, or 100 micrograms in MF59 adjuvant (substance that can~     improve vaccine effectiveness). The volunteers will be assigned randomly (by chance) to 1 of~     4 different groups. Volunteers in each group will receive a shot of the vaccine or a placebo~     (shot with no medication). Participants will be involved in study related procedures for up~     to 71 weeks, which includes blood samples, recording symptoms on a diary card, and 4 vaccine~     or placebo injections.~   "
233425|NCT00500734|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this laboratory research study is to collect and store blood and tissue from~     patients who have a diagnosis of heart disease and may be at a high risk for the development~     of heart failure. This blood may be used in the future to identify genes that may play a role~     in developing congestive heart failure (CHF) from chemotherapy or other sources.~      This is an investigational study. All will be enrolled at MD Anderson.~   "
233426|NCT00500721|"~     To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of HCV-796~     and a single dose of desipramine when coadministered to healthy subjects.~   "
233427|NCT00500708|"~     The overall objective of the DISCERN study is to develop and validate a genomic diagnostic~     assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden~     cardiac death (SCD).~   "
233428|NCT00500695|"~     This project will assess the utility of a brief motivational intervention to engage smokers~     with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a~     brief motivational intervention will be more effective in engaging smokers with schizophrenia~     to tobacco dependence treatment than an educational intervention. The educational~     intervention will increase the likelihood to reducing cigarette intake and/or attending~     tobacco dependence treatment by teaching subjects about the negative effects of smoking and~     the success of tobacco dependence treatment. The motivational intervention will increase the~     likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by~     increasing subjects' motivation to change by presenting objective and personalized~     information regarding their smoking behaviors in a non-judgmental and supportive manner.~   "
233429|NCT00500682|"~     1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to~     standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first~     occurrence of any event of the triple composite outcome of initiation of dialysis, kidney~     transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate~     the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate~     the effects of AST-120 versus placebo, on other measures of renal function.~   "
233430|NCT00500669|"~     To investigate whether Betadine can reduce infection rates and recurrence rates following~     varicose veins surgery in a randomized double blind placebo controlled study.~   "
233431|NCT00500656|"~     Primary Outcome Measures:~      The primary endpoint was the time to onset of symptom relief of the first attack in the~     double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic~     acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid~     refers to the hazard rate under tranexamic acid.~      Secondary Outcome Measures:~        -  Additional efficacy assessments (Time to Almost Complete Symptom Relief)~        -  Safety and tolerability~        -  Pharmacoeconomics~   "
233432|NCT00500630|"~     The goal of this study was to clinically validate a new device for the objective outcome~     evaluation of adult patients undergoing shoulder surgery for glenohumeral osteoarthritis and~     rotator cuff disease, using the activities of daily living described in the Simple Shoulder~     Test (SST) as a reference.~      The study was set up as a clinical trial including patients over an observation period of one~     year and a control group of subjects. Clinical evaluations will be made at baseline, 3~     months, 6 months and 1 year after surgery by two independent observers. Miniature sensors~     each containing three 3D gyroscopes and three 3D accelerometers will allow computing new~     kinematic scores. They will be compared to the regular SST, DASH, ASES and Constant scores.~   "
233433|NCT00500617|"~     The PREDICT study is to develop and validate a diagnostic blood ASGES (age, sex, gene~     expression score) or Corus CAD for atherosclerotic coronary artery disease (CAD). The Corus~     CAD (Age/Sex/Gene Expression score - ASGES) will use quantitative real-time PCR (RT-PCR) to~     quantify the expression of multiple genes from circulating peripheral blood cells to assess~     the presence of clinically significant CAD in a patient.~   "
233434|NCT00500604|"~     The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg~     against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP)~     as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.~      The secondary objectives are:~        -  To compare the percentage of patients with normal blood pressure as measured by HBPM and~          at the doctor's office at weeks 16 and 24~        -  To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and~          evening SBP and DBP evaluated by HBPM at weeks 16 and 24~        -  To compare the difference in mean SBP evaluated by HBPM at week 16~        -  To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks~          16 and 24~        -  To determine the incidence and severity of adverse events~   "
233435|NCT00500591|"~     It is known that women who are obese are at higher risk of endometrial cancer (cancer of the~     lining of the uterus or womb). The goal of this clinical research study is to find out how~     common abnormalities of the endometrium are in women who are considered obese and to find out~     if those same abnormalities are less common in women who are considered to be thin.~     Researchers would like to learn if obese patients have symptoms (like irregular menstrual~     cycles) that may mean there could be an abnormality present. Researchers would also like to~     know if obese women have access to regular female exams and whether they routinely go to~     their primary care doctors.~   "
233436|NCT00500578|"~     Primary Objectives:~        1. To determine whether aerosolized ribavirin is effective when given at an intermittent~          dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection~          (URI) and whether it can prevent progression to pneumonia.~        2. To determine the effect of this regimen on persistence of viral shedding.~   "
233437|NCT00500565|"~     The objective of this pilot study is to examine the efficacy of the ON~Q Pain Relief System~     plus Intravenous Patient Controlled Analgesia (IVPCA) with Morphine vs IV PCA alone in~     patients undergoing free transverse rectus abdominis musculocutaneous (TRAM) flap surgery.~     The primary outcome measure will be postoperative opioid analgesia requirements. Other~     outcomes will also be assessed, including pain scores, quality of recovery, and resource~     utilization.~   "
233438|NCT00500552|"~     Hypertrophic Cardiomyopathy (HCM) is a relatively common inherited heart muscle disease. Many~     patients experience symptoms of breathlessness, fatigue and chest pain. These symptoms are~     not always controlled with current therapies.~      Recently the investigators showed that a drug called Perhexiline markedly improved exercise~     capacity and symptoms in patients with heart failure. In this proposal the investigators wish~     to test whether Perhexiline improves exercise capacity and relieves symptoms in patients with~     HCM~   "
233439|NCT00500539|"~     The primary objective of this study is to assess the immunogenic potential of the liquid~     formulation of omalizumab administered over a period of 6 months in moderate to severe~     persistent allergic asthma patients 12 years of age or older, with no previous exposure to~     the drug (omalizumab naïve patients). The secondary objective of this study is to assess the~     safety of the liquid formulation of omalizumab in the same patients.~   "
233440|NCT00500526|"~     The purpose of this study is to investigate the effects of the practice of singing for a long~     period of time on pulmonary function data, quality of life, and dyspnea sensation of patients~     with COPD in stable clinical conditions. As singing is a type of respiratory training, the~     study hypothesis is that singing would improve maximal respiratory pressures, dyspnea~     sensation, and overall quality of life of these patients.~   "
233453|NCT00500357|"~     This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further~     evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate~     vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC,~     and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This~     study will determine if a subsequent dose of 13vPnC one year later results in similar or~     greater immune response (body's ability to protect against disease) than that measured after~     the initial dose of 13vPnC.~   "
248636|NCT00298298|"~     To determine if a vaccine made from patient's own tumor tissue can stimulate an immune~     response against the patient's tumor cells. To determine the safety of the vaccine~   "
233441|NCT00500513|"~     Objectives:~        -  To determine the safety of fiducial implantation.~        -  To determine the extent/rate of migration of radio-opaque fiducials placed in lung~          tumors and adjacent normal tissue.~        -  To compare real-time portal imaging-based fiducial tracking with measurement of~          three-dimensional motion by four-dimensional CT scanning to determine how many fiducials~          are needed to track a tumor.~        -  To determine if intra-fractional lung tumor motion changes during a course of treatment,~          and when during the treatment this occurs.~        -  To correlate the position of internal fiducials with the position of the external~          patient surface during respiration.~        -  To quantify the residual motion of the clinical target volume during radiotherapy gated~          using external fiducials.~        -  To verify the adequacy of the treatment portal margins in encompassing the residual~          motion of the clinical target volume.~        -  To determine if radio-opaque fiducial placement adjacent to the trachea (which does not~          move) can reduce daily setup inaccuracies, and so spare normal tissue.~        -  To determine the motion of hilar adenopathy (if any), and whether it correlates with~          motion of the primary tumor.~   "
233442|NCT00500500|"~     The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the~     isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate~     Alzheimer's disease.~   "
233443|NCT00500487|"~     Adolescents are at risk for HIV because of sexual and drug behavior intiated during this~     developmental period. Those with psychological distress are less likely than their peers to~     benefit from frequently used skills-based interventions. It appears that emotional lability~     during sexual situations disrupts skills learned. This project will implement and evaluate~     interventions for adolescents with psychiatric disorders who are in therapeutic school~     settings. Affect management and skills-based interventions will be compared to a didactic~     standard of care condition to determine which intervention best reduces risk behavior among~     adolescents with psychiatric disorders in therapeutic school settings.~   "
233444|NCT00500474|"~     Meniere's disease is a common inner ear disease with an incidence of 15-50 per 100,000~     population. Since Meniere’s disease is thought to be triggered by an immune insult to inner~     ear, we examined intra-endolymphatic sac application of large doses of steroids as de novo~     treatment for intractable Meniere’s disease.~   "
233445|NCT00500461|"~     GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This~     will be an open-label, dose-ascending study in 7 healthy male subjects to establish well~     tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is~     to confirm an IV and oral dose for a definitive human radiolabel metabolic study.~   "
233446|NCT00500448|"~     Patients with knee osteoarthritis (OA) often have decreased thigh muscle strength. This~     muscle weakness is thought to originate from centers in the brain and spinal cord that~     restrict recruitment of fibers responsible for muscle contraction. An inability to fully~     contract muscles surrounding the knee joint impairs patients' abilities to perform activities~     of daily living (i.e. walking, climbing stairs) and may even contribute to further joint~     degeneration.~      Establishing therapies aimed at increasing muscle strength, restoring normal function, and~     possibly slowing the processes involved in the development of knee OA is essential in order~     to enhance the quality of life in the adult population plagued with this degenerative joint~     condition.~      Electrical muscle stimulation applied to the thigh is a promising therapy that has been shown~     to successfully restore muscle strength, however how long the treatment lasts and its~     influence on functional outcomes remains unknown. In order for electrical muscle stimulation~     to be of value it must result in sustained improvements in muscle strength and functional~     outcomes. Therefore, the purpose of the proposed investigation is to determine if electrical~     muscle stimulation can restore thigh muscle strength and improve functional outcomes in~     patients with knee osteoarthritis.~   "
233447|NCT00500435|"~     Primary Objectives:~        -  To determine the feasibility of performing an extraperitoneal laparoscopic~          lymphadenectomy in patients with stage IB2-IVA cervical carcinoma who are dispositioned~          to undergo radiotherapy and concurrent chemotherapy.~        -  To document intraoperative and postoperative complications in patients undergoing~          extraperitoneal laparoscopic lymphadenectomy.~        -  To determine the rate of lymph node metastases in the para-aortic region in patients~          with stage IB2-IVA cervical cancer.~        -  To correlate histopathological findings in the para-aortic lymph nodes with preoperative~          imaging studies (Positron emission tomography (PET) and magnetic resonance imaging (MRI)~          and computed tomography (CT)).~   "
233448|NCT00500422|"~     The goal of this clinical research study is to find the highest safe dose of the drug Velcade~     (bortezomib) that can be given together with gemcitabine and pegylated liposomal doxorubicin~     (Doxil) in the treatment of advanced cancer. The effect of this combination treatment on~     tumor growth will also be studied.~   "
233449|NCT00500409|"~     OSTEOFORM, containing recombinant (rhPTH [1-34]), enhances bone mineral density and reduces~     risk for vertebral fracture. This study evaluates the safety and efficacy of OSTEOFORM in the~     treatment of osteoporosis in post-menopausal women.~   "
233450|NCT00500396|"~     Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in~     epithelial and tumor cells (1). Normal Retinal vascularization has two phases: In the first~     fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of~     gestation). In the second phase, denominated angiogenesis phase, the superficial and deep~     capillary plexus are formed (15,20). The Retinopathy of Prematurity (ROP) was described for~     the first time in 1942 (4), at the present moment it is a public health problem in the~     developing countries. The International Classification of ROP classifies it in 5 stages,~     dividing it in 3 anatomical zones. It is a public health problem that continuous without~     having an effective prophylaxis. The early diagnosis and treatment in thresholds stages have~     changed the prognosis of this disease (11,12).~   "
233451|NCT00500383|"~     This study aims to evaluate if a light based technique, called Optical Breast Spectroscopy~     (OBS) formerly known as Transillumination Breast Spectroscopy (TiBS), can be used to detect~     differences in breast tissue between high- and low-risk populations and within the high-risk~     population between BrCa1 or 2 carriers and non-carriers. These differences may include~     differences in breast tissue composition and metabolism at time of enrollment into the study~     (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue~     change over time (possibly reflecting rate of tissue transformation from normal to ultimately~     malignant state).~   "
233456|NCT00500318|"~     This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in~     reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It~     was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind~     treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria~     were randomized to one of two treatment groups: aclidinium bromide or placebo.~   "
233457|NCT00500305|"~     A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants.~     Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type~     natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP~     guided therapy could reduce doses of indomethacin.~   "
233458|NCT00500292|"~     The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in~     combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients~     who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.~   "
233459|NCT00500279|"~     To evaluate the effect of celecoxib use for 3 month after drug-eluting stent implantation~        -  on restenosis~        -  on clinical outcome such as target lesion revascularization, thrombotic event,~          myocardial infarction, death~        -  on inflammatory biomarkers~   "
233460|NCT00500253|"~     The aim of this study is to assess the utility of exhaled nitric oxide measurement (FeNO) in~     treatment monitoring in children with asthma.~      According to the aim of the study following assumptions are formulated:~        1. Comparison of annual cumulative steroid dose, number of bronchodilator doses taken,~          number of asthma exacerbation, number of hospitalisation due to asthma, between group of~          children with asthma with FeNO monitored treatment (study group), and group of children~          with treatment monitored by GINA's grade of disease clinical control (control group)~        2. Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function~          (FEV1)~        3. Comparison of values of non-specific bronchial hyperresponsiveness with methacholine~          (PC20M)between both study groups after 12. months of treatment.~   "
233461|NCT00500240|"~     The goal of this clinical research study is to learn if intense management and control of~     blood sugar levels during treatment for acute lymphocytic leukemia, Burkitts lymphoma, or~     lymphoblastic lymphoma will result in decreased risk of relapse, fewer complications, and/or~     longer survival.~   "
233462|NCT00500227|"~     The objective of this study is to evaluate, in acromegalic patients with disease persistence~     after surgery who are treated with somatostatin analogues, the histopathological, clinical,~     morphological and biochemical factors which are predictive of hormonal control.~   "
233463|NCT00500214|"~     this study was designed to evaluate the effect of routine excision of the ilioinguinal nerve~     in an attempt to decrease the incidence of chronic inguinodynia in patients who undergo open~     anterior hernia mesh repair.~   "
233464|NCT00500201|"~     Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we~     plan to have only single tablets administered in the later phase clinical trials but we have~     not had a 120mg strength before. As this is a new previously untested strength we need to~     ensure that the PK is similar to that achieved using 2x60mg before we start a large~     manufacturing campaign and before we administer to a large number of patients. The study is~     planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of~     18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be~     given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812~     is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If~     the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be~     stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final~     dose.It is expected that the total duration of the study should be approximately 11 weeks.~   "
233465|NCT00500188|"~     Primary objectives~        1. To determine whether induction of apoptosis or inhibition of angiogenesis are involved~          in the antitumor activity of (Gleevec, Formerly STI-571) in patients with~          gastrointestinal stromal tumors (GIST) as assessed by Positron Emission Tomography (PET)~          scanning.~        2. To determine whether dynamic computed tomography (CT), PET scan, molecular and~          histopathologic responses in GIST tumors from patients treated with Gleevec predict~          Disease-Free Survival (DFS) time.~      Secondary objectives~        1. To determine the disease free survival of patients with resectable or partially~          resectable gastrointestinal stromal tumors treated with Gleevec preoperatively and~          continued for 2 years after resection of disease.~        2. To assess the safety and tolerability of Gleevec given to patients with GI stromal~          tumors 3, 5, or 7 days preoperatively and continued postoperatively.~   "
233466|NCT00500175|"~     More than half of all lower extremity amputations are in persons with diabetes. These~     patients suffer from severe, diabetes-induced, peripheral, sensory neuropathy and, thus they~     frequently do not protect their feet from repetitive shear stress or traumatic episodes and~     ulceration often ensues. We have previously shown that the temperature profile of the plantar~     aspects of the foot provides a reliable warning of tissue injury and can be effectively used~     as a preventive modality. In this study we propose to further develop and clinically test a~     novel infrared-based temperature instrument (TempTouchRM®) that is intended for home use by~     high-risk diabetic patients. This step-on remote monitoring device will serve as an early~     warning system for impending ulcers and Charcot fractures. The study’s central hypothesis is~     that the TempTouchRM device will reduce the incidence of ulcers by providing an accurate,~     simple, and effective approach to monitor changes in foot temperatures.~   "
233485|NCT00499928|"~     This study will examine the biological fate of radioactive SB-751689 administered to healthy~     males and healthy postmenopausal women. Subjects will receive a single oral dose of~     radioactive SB-751689. Excreta and blood samples will be taken over the course of 7 days.~     This study will help determine the major route of elimination of SB-751689 in humans. It will~     also provide samples (blood, plasma, urine, and stools) for analysis of metabolites, if any.~   "
233502|NCT00499707|"~     The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment~     with rosiglitazone/metformin will safely and effectively control glycemia as first line oral~     therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate~     superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.~   "
233467|NCT00500162|"~     Melasma is an acquired, symmetric, irregular hypermelanosis on sun-exposed areas of the face,~     commonly seen in Latin American women. It is a very frequent disease, although its true~     incidence is unknown.~      Melasma has historically been difficult to treat and therapy remains a challenge for this~     chronic condition.~      Melasma being a relapsing disease, there is a real need to address how to maintain efficacy~     achieved after acute treatment. A previous 12-month trial has shown that Tri-Luma® applied~     once daily over a long-term period is safe and tolerable. However, there are no robust data~     available either on the efficacy of Tri-Luma® in long-term treatment or guidance for a~     maintenance dosage regimen with this product.~      Investigations have been made through a feasibility work among Dermatologists from USA and~     Latin America to assess their current practice in terms of Maintenance Therapy. Two regimens~     appear to be prescribed frequently and will be compared in this study.~      The expectation is that Tri-Luma® will be effective, in one of the two regimens explored, in~     maintaining the Melasma improvement achieved with a previous treatment of Tri-Luma®.~   "
233468|NCT00500149|"~     The primary objective of this study is to assess the time of onset of Vyvanse compared to~     placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and~     Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with~     Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
233469|NCT00500136|"~     This study was designed to examine if provoking thoughts of mortality among medical students~     can influence cardiac risk assessments depending on the religion of the target patient.~   "
233470|NCT00500123|"~     The Alpha-1 Coded Testing (ACT) Study was established to study genetic testing and outcomes~     of individuals at risk for alpha-1 antitrypsin deficiency.~   "
233471|NCT00500110|"~     Primary Objective:~      1. To evaluate the pathological complete response rate to neoadjuvant hormonal ablation,~     Imatinib and Docetaxel (HID) in high-risk localized prostate cancer.~      Secondary Objectives:~        1. To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant~          HID and radical prostatectomy in high-risk localized prostate cancer.~        2. To correlate pathological response with modulation of the Platelet-Derived Growth Factor~          Receptor (PDGFR) pathway.~   "
233472|NCT00500097|"~     The purpose is to assess accuracy of digital retinal image interpretation by technicians and~     direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and~     the presence of diabetic macular edema for the identification of referrals to~     ophthalmologists. The results of both screening methods were compared with comprehensive eye~     examination by ophthalmologists.~   "
233473|NCT00500084|"~     This is an open-label, single-arm clinical study investigating the long-term safety of~     ALTU-135 treatment in Chronic Pancreatitis (CP) patients with exocrine Pancreatic~     Insufficiency (PI).~   "
233474|NCT00500071|"~     Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with~     ADHD are dosed to optimal effect.~   "
233475|NCT00500058|"~     The purpose is to identify a dose of SB-485232 which is safe, tolerable and effective when~     used in combination with Rituximab in patients with non-Hodgkin's lymphoma (NHL). This study~     will use a standard treatment regimen of Rituximab in combination with rising doses of~     SB-485232. The dose selected from this study will be used in a future studies.~   "
233476|NCT00500045|"~     The aim of this study is to develop a less risky, yet effective and more sustainable~     treatment for retinal vein occlusions than the current commonly used approach of repeated~     intravitreal triamcinolone acetonide (Kenalog) injections. The types of retinal vien~     occlusion that are being studied include central (CVRO), hemi-retinal (HRVO),and branch~     (BRVO) retinal vein occlusion. Niacin, (Nicotinic Acid, not Nicotinamide) a B-vitamin, has~     lipid lowering and vasodilating properties. The combination of Niacin and Prednisolone~     Acetate steroid eye drops as a non-invasive treatment approach was developed by the Principal~     Investigator. The Niacin dilates the retinal vessels, hopefully encouraging earlier~     collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous~     outflow. The Prednisolone Acetate steroid eye drops are aimed at reducing vascular leakage~     and therefore the macular edema in the eye while the Niacin is taking effect.~   "
233477|NCT00500032|"~     Subjects who have completed study 6108A1-500, in which our experimental meningoccal B vaccine~     or placebo was administered, will be approached for inclusion into this study which is purely~     for blood draw. The sera will be used for assay development.~   "
233478|NCT00500019|"~     Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from~     the uterine flora during non-elective Cesarean sections. We want to study whether the uterine~     flora can predict post-cesarean febrile morbidity and endometritis.~   "
233479|NCT00500006|"~     This study will evaluate MK0457 in combination with Dasatinib in patients with Chronic~     Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.~     Efficacy and Safety will be evaluated.~   "
233480|NCT00499993|"~     The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the~     control of Growth Hormone (GH) secretion in patients with active acromegaly.~   "
233481|NCT00499980|"~     The purpose of this study is to evaluate a dynamic near infrared imaging device for~     characterizing suspicious breast lesions~   "
233482|NCT00499967|"~     The purpose of this study is to assess the safety, tolerability and activity of GS-9191~     ointment in the treatment of genital warts. GS-9191 ointment is intended for topical~     application directly to genital warts on the skin.~   "
233483|NCT00499954|"~     This is a mono-centre trial performed at the Center for Clinical Research at the Medical~     University Graz. There will be a screening information and a study visit.In the study visit~     arterialized venous blood glucose values will be monitored and subcutaneous sampling of~     interstitial fluid (ISF) with microdialysis for glucose determination will be performed.~     Additionally to the laboratory analysis of the subcutaneous glucose samples, the glucose will~     be measured with extracorporeal on-line sensors and two marketed devices (Guardian RT and~     Glucoday S).The study visit will last 30 hours starting with the insertion of microdialysis~     catheters in the abdominal subcutaneous tissue and the insertion of the catheters for the~     Glucoday S system and Guardian RT system. The primary hypothesis of the study is:~     Interstitial fluid glucose concentration profiles correlate to the arterialized venous blood~     glucose concentration profile in type 1 diabetic subjects.~   "
233486|NCT00499915|"~     Premature infants have a significantly increased risk for developing respiratory illnesses~     and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing~     problems in children, thus exposure to smoke makes it substantially more likely for a~     premature infant to develop wheezing. The overall goal of this study is to test whether~     comprehensive asthma education combined with a home-based secondhand smoke reduction program~     can reduce exposure to smoke and prevent respiratory illness among premature infants. Our~     hypotheses are:~        -  More premature infants whose families receive asthma education combined with a SHS~          reduction intervention will live in smoke-free environments compared to infants~          receiving only asthma education (control group).~        -  Caregivers receiving the SHS reduction program will have higher rates of quit attempts~          and less relapse into smoking compared to caregivers in the control group.~        -  Infants whose families receive the combined intervention will experience less~          respiratory illness compared to infants in the control group.~   "
233487|NCT00499902|"~     The purpose of this study is to identify a safe and effective bolus dose of~     intra-arterial/intra-thrombus alfimeprase in acute ischemic stroke (AIS) 3 to 9 hours from~     symptom onset.~   "
233488|NCT00499889|"~     Primary Objective:~      To estimate the probability of molecular complete remission at one year for the described~     sequential treatment approach, with nonablative hematopoietic transplantation, post~     transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive~     Chronic Myelogenous Leukemia (CML) not in blastic transformation.~      Secondary Objective:~      Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual~     disease, response to donor lymphocyte infusion (DLI) for residual disease following imatinib~     mesylate therapy, as well as engraftment, toxicity, disease free survival and survival,~     effect of busulfan pharmacokinetics on study outcome.~   "
233489|NCT00499876|"~     The purpose of this study is to find out whether malaria affects how HIV/AIDS disease~     progresses in an infected patient, and to determine the effect of reducing malaria infection~     on HIV disease progression in Kumasi~   "
233490|NCT00499863|"~     To assess the efficacy and safety of efficacy of MTS compared to placebo~   "
233491|NCT00499850|"~     A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination~     with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy~     in patients with advanced colorectal adenocarcinoma.~   "
233492|NCT00499837|"~     Cystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs~     produce considerable quantity of thick, sticky secretions that clog the airways, promote~     bacterial growth and lead to chronic obstruction, inflammation and destruction of the~     airways.~      The purpose of this study is to collect data about the resolution of the chronic inflammatory~     state in addition to assure the safety of the therapy in CF patients.~   "
233493|NCT00500266|"~     To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly~     subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide~     vaccine (23vPS) at least 3 years before study enrollment.~   "
233494|NCT00499824|"~     To test whether the International Diabetes Federation - Western Pacific Region (IDF-WPR)~     Guidelines are more effective than standard practices in primary care (general practitioner)~     clinics for the management of type 2 diabetes mellitus (T2DM) in Asia. A 12-month~     multinational multicentre prospective cluster randomisation clinical trial within a primary~     care setting, with 2 parallel treatment arms: diabetes management using IDF-WPR guidelines~     versus standard clinic practices. 400 subjects will be recruited from 100 sites (4 subjects~     per site) in ten Asian countries (China, Hong Kong, Indonesia, Korea, Malaysia, Philippines,~     Singapore, Taiwan, Thailand and Vietnam).~   "
233495|NCT00499811|"~     This phase I trial is studying the side effects and best dose of vorinostat in treating~     patients with metastatic or unresectable solid tumors or lymphoma and liver dysfunction.~     (closed for accrual as of 04/05/2010) Vorinostat may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Vorinostat may have different effects in~     patients who have changes in their liver function.~   "
233496|NCT00499798|"~     RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors~     may help doctors learn about the long-term effects of treatment and plan the best treatment.~      PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in~     patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.~   "
233497|NCT00499785|"~     RATIONALE: Learning about physical ability and mental function over time in older patients~     with acute myeloid leukemia may help doctors learn about the long-term effects of treatment~     and plan the best treatment.~      PURPOSE: This clinical trial is assessing physical and mental status in older patients with~     newly diagnosed acute myeloid leukemia.~   "
233498|NCT00499759|"~     RATIONALE: An individualized exercise program may be effective in lessening fatigue and~     depression and improving quality of life in patients undergoing chemotherapy for leukemia.~      PURPOSE: This clinical trial is studying how well individualized exercise programs work in~     patients receiving chemotherapy for newly diagnosed acute or relapsed myeloid leukemia or~     lymphoblastic leukemia.~   "
233499|NCT00499746|"~     This research is part of a set of studies whose purpose is to test whether tramadol can be~     used for the treatment of opioid addiction. Tramadol is already available in the United~     States as a pain medicine marketed as Ultram. It has effects similar to morphine, and it may~     also have effects similar to other drugs like stimulants. The doses of tramadol used in this~     study are higher than those generally used for the treatment of pain. To be in this study a~     participant must be a user of opioids (drugs like heroin) and stimulants (drugs like~     cocaine), but cannot be addicted to either. The person must be between 21-55 years old, and~     generally healthy. Up to 12 people will take part in this study.~   "
233500|NCT00499733|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with~     cryoablation may kill more cancer cells.~      PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with~     cryoablation works in treating patients with advanced or metastatic epithelial cancer.~   "
248661|NCT00297960|"~     Healthy volunteers will undergo euglycaemic hyperinsulinaemic clamp and microdialysis before~     and after administration of 10mg olanzapine or 80mg ziprasidone during 10 days.~   "
233503|NCT00499694|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such~     as satraplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may~     kill more tumor cells.~      PURPOSE: This clinical trial is studying how well giving satraplatin together with~     bevacizumab works in treating patients with metastatic prostate cancer previously treated~     with docetaxel.~   "
233504|NCT00499681|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by lowering the amount of estrogen the body makes.~     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving letrozole together with lapatinib before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This randomized phase II trial is studying how well giving letrozole together with~     lapatinib works in treating postmenopausal women with stage I, stage II, or stage III breast~     cancer that can be removed by surgery.~   "
233505|NCT00499668|"~     RATIONALE: Antiemetic drugs, such as aprepitant and ondansetron, may help lessen nausea and~     vomiting caused by opioids. It is not yet known whether aprepitant is more effective than~     ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.~      PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works~     compared to ondansetron in treating nausea and vomiting caused by opioids in patients with~     cancer.~   "
233506|NCT00499655|"~     RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of~     lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with~     celecoxib may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride~     together with celecoxib works compared with erlotinib hydrochloride alone in treating~     patients with stage IIIB-IV non-small cell lung cancer.~   "
233507|NCT00499642|"~     This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled,~     4-period crossover study.~   "
233508|NCT00499629|"~     The primary purpose of the study is to evaluate the safety of FXR-450 in healthy subjects.~     This study will also evaluate pharmacokinetics (PK) of FXR-450 in healthy subjects.~   "
233509|NCT00499616|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and~     doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma~     cells become more like normal cells, and grow and spread more slowly. Giving combination~     chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor~     can be surgically removed. It is not yet known what is the minimal amount of chemotherapy~     needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and~     prevent tumor recurrence or metastases.~      PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable~     biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles~     administered and by allowing for up to 50% residual tumor volume for patients with localized~     disease.~   "
233510|NCT00499603|"~     The goal of this clinical research is to learn if RAD001 given in combination with~     chemotherapy will turn off the signaling pathway (a chain of information that tells cancer~     cells to grow quickly) and make the chemotherapies given on this study more effective.~      Primary Objective~      · To determine if the addition of an mTOR inhibitor to standard neoadjuvant chemotherapy in~     patients with triple receptor-negative breast cancer causes molecular changes~     (inhibition/activation) of the PI3K/PTEN/AKT pathway.~      Secondary Objectives~        -  To evaluate pathologic complete response (pCR) rates for each treatment group.~        -  To evaluate the relationship between pCR and the molecular changes~          (inhibition/activation) of the PI13K/PTEN/AKT pathway in each treatment group.~        -  To evaluate overall response rates (ORR) for each treatment group.~        -  To assess the toxicity of both regimens and to evaluate the relationship of toxicities~          with PI3K/PTEN/AKT pathway status.~   "
233511|NCT00499590|"~     The purpose of this study is to compare the safety and effectiveness of bevasiranib given~     either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of~     Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with~     wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three~     treatments options for 104 weeks.~   "
233512|NCT00499577|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Drugs used in chemotherapy use different ways to stop cancer cells from~     dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by~     stopping blood flow to the cancer. A stem cell transplant using stem cells from the patient~     may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer~     cells. Giving an infusion of the donor's T cells after the transplant may help destroy any~     remaining cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects of stem cell transplant given~     together with chemotherapy and biological therapy and to see how well it works in treating~     patients with high-risk or refractory multiple myeloma.~   "
233513|NCT00499551|"~     The multiple properties of the corticosteroids over the inflammatory response, make them~     first line drugs for the treatment of several ocular inflammatory disorders of different~     etiologies. In order to diminish the corticosteroids severe systemic adverse effects, the~     local administration is preferred. Iontophoresis already has been used in a successful way~     for the administration of corticosteroids. Clinical or histopathological injuries due to the~     use of transcleral CCI have not been observed. being successful the administration of~     methylprednisolone by means of this system in previous studies. The objective is to evaluate~     the tolerance, security and effectiveness of this treatment, using a new generation device.~   "
233514|NCT00499538|"~     To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a~     reference capsule and an oral solution in healthy subjects.~   "
248840|NCT00295594|"~     To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids~     together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.~   "
233515|NCT00499525|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. Giving paclitaxel together with sorafenib may~     kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well paclitaxel works when given~     together with or without sorafenib in treating patients with locally recurrent or metastatic~     breast cancer.~   "
233516|NCT00499512|"~     The goal of this psychosocial research study is to examine and explain the influence of~     spirituality on patients with ovarian, primary peritoneal or fallopian tube cancer.~   "
233517|NCT00499499|"~     The purpose of this study is to investigate E7107 in patients with solid tumors. This is an~     open label, dose-escalation study of E7107. The maximum tolerated dose (MTD) of the single~     agent will be established by determining the occurrence of dose limiting toxicities during~     the first three weeks of therapy (Cycle 1). Patients in this study will be treated at~     multiple dose levels, starting at 0.6 mg/m^2. Patients will receive E7107 as a 30-minute~     intravenous infusion on Days 1 and 8 every 21 Days.~   "
233518|NCT00499486|"~     RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with~     advanced pancreatic cancer.~   "
233519|NCT00499473|"~     This phase II trial is studying how well sunitinib works in treating patients with recurrent~     malignant gliomas. Sunitinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
233520|NCT00499460|"~     RATIONALE: Garlic supplements may alter the pharmacokinetics of oxycodone, thereby affecting~     its effectiveness as an opioid analgesic for the relief of moderate or severe pain.~      PURPOSE: This randomized phase 4 trial is studying how garlic supplements may change the~     pharmacokinetics of oxycodone and its analgesic and side effects in healthy volunteers.~   "
233521|NCT00499447|"~     RATIONALE: Radiofrequency ablation uses a high-frequency electric current to kill tumor~     cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     radiofrequency ablation together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving radiofrequency ablation together~     with external-beam radiation therapy works in treating patients with stage I non-small cell~     lung cancer that cannot be removed by surgery.~   "
233522|NCT00499434|"~     This study aims at correlating TNF-α, INF-γ, IL-2, IL-4, IL-10 and TGF-β values as dosed by~     ELISA and mRNA expression by real-time PCR with histopathological hepatic biopsy findings in~     individuals with HIV/HCV coinfection. This population will be divided into three groups (G1:~     with no HAART; G2: with detected HIV viral load (HIV VL); G3: with undetected HIV VL), which~     will be then compared to two control groups with monoinfection by HIV or by HCV, in addition~     to a third control group comprising normal blood donors.~   "
233523|NCT00499421|"~     The goal of this clinical research study is to evaluate a system for localizing (targeting~     for treatment) the prostate for external beam radiation therapy. The system will be used to~     locate the prostate before treatment and to measure movement of the prostate during~     treatment. The data collected with the system will be compared to CT images taken during the~     course of your radiation therapy treatment. Researchers will try to use this information to~     verify the performance of the system, which could lead to improved positioning and tracking~     of the prostate during treatment.~   "
233524|NCT00499408|"~     RATIONALE: Vitamin D and soy extract may be effective in lowering prostate-specific antigen~     (PSA) levels in patients with recurrent prostate cancer that has not responded to previous~     treatment.~      PURPOSE: This phase II trial is studying how well giving vitamin D together with soy~     supplements works in treating patients with recurrent prostate cancer.~   "
233525|NCT00499395|"~     RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET imaging, may be effective~     in detecting residual disease after radiofrequency ablation of liver metastases in patients~     with colorectal cancer.~      PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it~     works for early detection of residual disease in patients undergoing radiofrequency ablation~     of liver metastases from colorectal cancer.~   "
233526|NCT00499382|"~     Primary Objective:~        -  Evaluate the agreement between radionuclide ventriculography (RNV) and gated F-18~          fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) in~          calculating left ventricular ejection fraction (LVEF), end diastolic volume (EDV) and~          end systolic volume (ESV).~   "
233527|NCT00499369|"~     This randomized phase III trial is studying giving irinotecan and cetuximab together with~     bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in~     treating patients with metastatic colorectal cancer that progressed during first-line~     therapy. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether~     irinotecan and cetuximab are more effective with or without bevacizumab in treating~     metastatic colorectal cancer.~   "
233539|NCT00499200|"~     The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation~     in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy~     elderly subjects and in Alzheimer's Disease (AD) subjects.~   "
233540|NCT00499187|"~     Cross-sectional cohort study of participants with HIV with or without protocol-defined~     Fanconi syndrome (confirmed creatinine clearance [CLcr] decline and evidence of proximal~     tubulopathy).~   "
233552|NCT00499031|"~     This phase II trial is studying cetuximab to see how well it works in treating patients with~     persistent or recurrent cervical cancer. Monoclonal antibodies, such as cetuximab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them.~   "
233528|NCT00499356|"~     We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear~     forces on the foot. No commercially available insoles are designed to reduce shear. Although~     insurance providers spend millions on diabetics’ therapeutic insoles, there is no scientific~     data about shear or pressure reduction. We will evaluate the optimal bonded materials from~     Phase I compared to the Glidesoft™ design using the same combination of viscoelastic~     materials. We evaluate 2 patient groups of 150 patients per arm (300 total) in an 18 month~     trial. The control group patient arm wore a traditional bonded insole whereas another the~     second arm receive the GlideSoft™. At baseline, and at the end of the 18 month trial, in-shoe~     gait lab and in vitro biomechanical parameters measured pressure, shear, and material~     properties as these changed with wear. This Phase II eighteen (18) month clinical trial~     evaluated the effectiveness of ShearSole™ reducing the incidence of diabetic ulcers. The~     overall study hypothesis was that GlideSoft™ provides significant shear reduction as compared~     to traditional insoles without sacrificing pressure reduction characteristics or durability.~   "
233529|NCT00499343|"~     Primary Objectives:~        1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups.~        2. To determine the number of apheresis procedures, total stem cell yield/kg patient body~          weight and the toxicity profile in the two groups.~      Secondary Objectives:~        1. To determine the degree of expression of various adhesion molecules in the 2 groups and~          correlate with time to engraftment of neutrophils, platelets, and red blood cells,~          efficacy of stem cell mobilization and purging.~        2. To determine the incidence of disease progression/relapse at 12 months in the two~          groups.~   "
233530|NCT00499330|"~     RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than~     lobectomy for non-small cell lung cancer and may have fewer side effects and improve~     recovery. It is not yet known whether wedge resection or segmentectomy are more effective~     than lobectomy in treating stage IA non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying different types of surgery to compare~     how well they work in treating patients with stage IA non-small cell lung cancer.~   "
233531|NCT00499317|"~     Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a condition with several causes~     of which some remain unknown. It is believed that some types of CP may be genetic or passed~     down (inherited) from one generation to the next.~      In this study, we are collecting genetic material and medical information to try to determine~     if there are genetic factors may play a role in CP/CPPS. We will be collecting DNA (from~     Saliva) and urine from each participant. Individuals and families with CP/CPPS will be~     enrolled. Family members of an individual with CP/CPPS are eligible whether or not they also~     experience CP/CPPS symptoms.~   "
233532|NCT00499304|"~     The aim of this study is to distinguish COPD patients with expiratory flow limitation in body~     plethysmography (open loop) from the patients without expiratory flow limitation in body~     plethysmography (closed loop) with the obtained FOT parameters.~   "
233533|NCT00499291|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~      PURPOSE: This clinical trial is studying how well paclitaxel albumin-stabilized nanoparticle~     formulation works in treating patients with advanced or refractory solid tumors.~   "
233534|NCT00499278|"~     1. What are the characteristics of joint replacement patients (DRGs 209 & 210) served in~          IRFs and SNFs? How are they similar or different?~        2. How are the interventions and processes of care for joint replacement patients different~          in IRFs and SNFs?~        3. What specific interventions or combinations of interventions in IRFs and SNFs make the~          biggest difference in outcomes for joint replacement patients taking into account~          patient differences?~        4. Which joint replacement patients do better in an IRF and which do better in a SNF?~        5. What is the relative cost-effectiveness of IRF and SNF care for joint replacement~          patients?~        6. Are comorbidities among joint replacement patients an adequate indicator of additional~          medical need during the rehabilitation process? Can a severity-of-illness measure serve~          as a better indicator of medical need? Are patients with greater medical needs served~          better in an IRF or a SNF?~        7. Can we design a more efficient course of rehabilitation interventions for joint~          replacement patients in IRFs and SNFs to reduce the length of stay and costs?~   "
233535|NCT00499265|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     WX-671 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving gemcitabine together with WX-671 may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well gemcitabine works when given~     together with WX-671 or when given alone in treating patients with locally advanced~     pancreatic cancer that cannot be removed by surgery.~   "
233536|NCT00499252|"~     This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized~     nanoparticle formulation works in treating patients with recurrent or persistent ovarian~     epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in~     chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing.~   "
233537|NCT00499239|"~     Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult~     patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study~     in sequential dose cohorts.~      Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and~     may receive a total of six treatment cycles based on toxicities and response. Patients who~     demonstrate disease progression will be discontinued from the study. Patients who, at the~     completion of six treatment cycles, tolerate treatment and show evidence of disease control~     (response or stabilization) will be eligible to continue receiving treatment at the same~     dose.~   "
233538|NCT00499213|"~     We have developed and implemented a program that offers home care assistance to patients~     wishing to perform home peritoneal dialysis, but are unable to do it for themselves. This~     study is being conducted to ensure the safety of this dialysis program and specifically, to~     see if the risk of being hospitalized is increased when this therapy is provided to patients.~   "
233541|NCT00499174|"~     RATIONALE: Sometimes prostate tumours may not need treatment until they progress. In this~     case, observation may be sufficient. Radical treatments, such as radical prostatectomy or~     radiation therapy, may be effective in treating prostate cancer when it is first diagnosed.~     It is not yet known whether active surveillance is more effective than radical treatment as~     an initial intervention in favorable prognosis prostate cancer.~      PURPOSE: This randomized phase III trial is studying active surveillance to see how well it~     works compared with radical treatment as an initial intervention in patients with favorable~     prognosis prostate cancer.~   "
233542|NCT00499161|"~     The purpose of this randomized clinical trial is to examine the effect of Patient-Centered~     Care (PCC) on a patient's level of satisfaction on discharge from an acute healthcare~     setting. Findings from this study will assist in determining if PCC, administered by nurses,~     should be instituted hospital wide.~      SPECIFIC AIMS:~        1. To examine the effect of Patient-Centered Care on patient satisfaction.~        2. To examine the effect of Patient-Centered Care on the quality of patient care.~        3. To examine the effect of patient's perception of nursing care on patient satisfaction.~   "
233543|NCT00499148|"~     The purpose of the study was to evaluate the effect of an herbal extract on postprandial~     glycemia following a meal.~   "
233544|NCT00499135|"~     This phase I trial is studying the side effects and best way to give sunitinib malate in~     treating patients with unresectable or metastatic kidney cancer or other advanced solid~     tumors. Sunitinib malate may stop the growth of tumor cells by blocking blood flow to the~     tumor and by blocking some of the enzymes needed for cell growth.~   "
233545|NCT00499122|"~     RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways~     and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin,~     cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells. Giving NOV-002 together with~     chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving oxidized glutathione (NOV-002)~     together with doxorubicin and cyclophosphamide followed by docetaxel works in treating women~     with newly diagnosed stage II or stage III breast cancer.~   "
233546|NCT00499109|"~     This is a clinical research study to evaluate if chemotherapy in the experimental arm (E)~     results in a better outcome compared to patients in the standard of care arm (C).~      2:1 randomization to experimental arm (E) or standard arm (C). In arm E, treatment of~     dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein~     level. In arm C, treatment of dual-agent chemotherapy will be gemcitabine/carboplatin, i.e.,~     standard of care.~   "
233547|NCT00499096|"~     The purpose of this research study is to learn whether or not people with bipolar disorder~     can reduce their risk of heart disease and related conditions by having a Care Manager~     provide self management and care management.~   "
233548|NCT00499083|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, and doxorubicin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Injecting the patient's dendritic cells directly into the tumor~     may stimulate the immune system and stop tumor cells from growing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Estrogen can cause the growth of breast cancer cells.~     Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by~     the tumor cells. Giving combination chemotherapy together with autologous dendritic cells~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed. Giving radiation therapy and hormone therapy after surgery may kill any tumor~     cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel~     together with cyclophosphamide and doxorubicin followed by autologous dendritic cells and~     surgery with or without radiation therapy and/or hormone therapy works in treating women with~     stage II or stage III breast cancer.~   "
233549|NCT00499070|"~     RATIONALE: Studying biopsy, bone marrow, and blood samples from patients with cytopenia that~     did not respond to treatment may help doctors learn more about the disease and plan the best~     treatment.~      PURPOSE: This laboratory study is assessing immune function in young patients with cytopenia~     that did not respond to treatment.~   "
233550|NCT00499057|"~     Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast~     cancer in patients at low risk of relapse as pathological and clinical findings have~     demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In~     our phase II prospective study PBI is administered with high-dose-rate brachytherapy in~     patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4~     days (total dose 32 Gy).~   "
233551|NCT00499044|"~     The investigators will compare the test-retest reliabilities of two cognitive batteries in~     people with schizophrenia: Cognitive Drug Research Computerized Cognitive Assessment System~     (CDR) and MATRICS Consensus Cognitive Battery (MCCB). The investigators hypothesize that~     there will be a statistically significant difference in the test-retest reliabilities between~     MCCB and CDR. In addition, the investigators hypothesize that each of the two batteries will~     better measure certain areas of cognition. The investigators also hypothesize that scores~     from both batteries will correlate with quality of life scores, and that there will be a~     significant difference between the correlations of MCCB and CDR. The investigators~     hypothesize there will be a significant difference in patients' self-reported tolerability~     and satisfaction of the MATRICS versus CDR assessments. Lastly, the investigators hypothesize~     that there will be a significant difference in the MATRICS versus CDR batteries with respect~     to an administrator-rated score of practicality.~      Approximately 32 subjects will enroll in the study. Following consent and eligibility~     screening (visit 1) and baseline clinical assessment and training in the use of the CDR~     battery (visit 2), subjects will be randomized into one of two groups for visits 3 and 4. One~     group will complete the CDR and then MCCB in visit 3, as well as the Tolerability Scale for~     each battery. The other group will complete the batteries in reverse order during visit 3.~     Each group will complete both batteries again in reverse order for visit 4. Randomization~     will be done in blocks of 2. After completion of every 4 subjects, study administrators will~     complete the Practicality Scale for each battery.~   "
233553|NCT00499018|"~     The purpose of this study is to define an improvement in patients randomized in four~     different arms:~      Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM~     + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are~     different in dose dense chemotherapy + Rituximab with or without intensified high dose~     chemoimmunotherapy and support of peripheral autologous stem cells.~   "
233554|NCT00499005|"~     Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of~     postpartum haemorrhage~   "
233555|NCT00498992|"~     RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an~     acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor~     receptor inhibitor for cancer.~      PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating~     rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor~     therapy for cancer.~   "
233556|NCT00498979|"~     RATIONALE: Sodium stibogluconate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor~     cells and slow the growth of melanoma and other cancers. Drugs used in chemotherapy, such as~     cisplatin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving sodium~     stibogluconate and interferon alfa-2b together with combination chemotherapy may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of sodium~     stibogluconate when given together with interferon alfa-2b, cisplatin, vinblastine, and~     dacarbazine in treating patients with advanced melanoma or other cancer.~   "
233557|NCT00498966|"~     This is a Phase II study. Patients with kidney carcinoma will be considered in two groups.~     The goals of this study are:~        -  To measure clinical benefit defined as tumor response or progression-free survival for~          more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed~          or have progressed on a VEGF receptor inhibitor~        -  To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney~          who have failed or have progressed on a VEGF receptor inhibitor~   "
233558|NCT00498953|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving combination chemotherapy together with radiation therapy, with~     or without lapatinib, before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed or eliminate the need for surgery.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of combination~     chemotherapy given together with radiation therapy with or without lapatinib and to see how~     well it works in treating patients with locally advanced cancer of the larynx or hypopharynx.~   "
233559|NCT00498940|"~     The purpose of this study is to investigate the efficacy of optimized temporary biventricular~     pacing (BiVP) in patients undergoing open-heart surgery with preoperative LV dysfunction and~     an intraventricular conduction delay. This study will compare extended temporary~     biventricular pacing versus standard of care by assessing patients randomized to the two~     groups, from the conclusion of cardiopulmonary bypass, until the conclusion of pharmacologic~     circulatory support in the intensive care unit. In addition, effects of biventricular pacing~     will be tested in all patients, at three time points, using different measures of blood flow.~     Results from this research will demonstrate whether temporary BiVP improves cardiac output~     after open-heart surgery and whether ventricular pacing optimization increases cardiac output~     in this setting. Success would lead to the development of recommendations for use of BiVP~     postoperatively and would stimulate the development of pacemakers with appropriate features.~      The primary hypothesis is that the optimum pacing protocol (POPT) will increase cardiac index~     (CI) by 15% (from approximately 2.30 to 2.64 L/min/m2) compared to standard of care as~     measured by thermodilution 12-24 hours postoperatively. Secondary objectives include defining~     POPT at three time points within 24 hours of surgery. The investigator will examine which~     forms of cardiac dysfunction benefit from temporary pacing using direct and indirect measures~     of perfusion and cardiac function. The investigator will also analyze survival, length of~     stay, incidence of arrhythmias, and cost of postoperative care.~   "
233560|NCT00498927|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients~     with recurrent glioblastoma multiforme or other malignant glioma.~   "
233561|NCT00498914|"~     A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate,~     efficacy, safety and tolerability of YM155~   "
233562|NCT00498901|"~     RATIONALE: Aromatase inhibitors, such as letrozole, prevent the formation of estradiol, a~     female hormone. Giving letrozole together with goserelin, leuprolide, or surgery may be an~     effective treatment in women with hormone-dependent breast cancer.~      PURPOSE: This phase II trial is studying how well giving letrozole together with goserelin or~     leuprolide works in treating premenopausal estrogen receptor-positive patients with stage IV~     breast cancer.~   "
233589|NCT00498537|"~     Introduction: Aldosterone seems to have deleterious effects on the kidneys. Many animal~     studies and few clinical trials now have shown that suppression of aldosterone by aldosterone~     receptor blockers ameliorated these effects.~      Method: In a double-blind, cross over study, 24 patients with diabetic nephropathy who were~     already receiving either ACE inhibitor(lisinopril 20-40 mg/day ) or ARB( losartan 25-100~     mg/day )were given spironolactone( 25 mg during the first month and 50 mg during the second~     and third month if serum K remained ok) or matching placebo with 1 month of washout in~     between. All patients were from a single center and exclusively male veterans. Blood~     pressure, serum creatinine, serum K and spot urine protein/creatinine were measured at the~     beginning and end of each study period. The study was started in May of 2003 and completed in~     May 2006.~   "
233590|NCT00498524|"~     The purpose of this study is to determine if heredity influences the risk of life-threatening~     heart rhythms (ventricular tachycardia and ventricular fibrillation) after heart attack~     (myocardial infarction).~   "
233563|NCT00498888|"~     -  Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong~          sensation to void.~        -  UUI usually associated with reduced bladder capacity.~        -  The pathophysiology is unclear.~        -  Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible~          mechanisms.~        -  Standard treatment includes anticholinergic medication and behavior modification.~        -  The study aims to compare the long term effectiveness of 4 different approaches to the~          treatment of women with Urge Urinary Incontinence (UUI):~             1. Pelvic Floor Rehabilitation (includes muscle training+behavioral~               intervention+bladder training)~             2. Pelvic Floor muscle training alone~             3. Bladder Training alone~             4. Drug treatment with Tolterodine.~        -  Study variables will include: impairment ratings, quality of life, and~          cost-effectiveness.~        -  This study addresses three issues:~             1. The long term efficacy and cost-effectiveness of the various treatment options.~             2. To identify the factors involved in determining the effectiveness of drug or~               behavioral therapy.~             3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we~               hope to shed light on the mechanism of dysfunction. A better response in one group~               will help localize the problem to pelvic floor muscles or to detrusor instability.~   "
233564|NCT00498875|"~     Primary Objectives:~        -  Develop and pilot test an innovative intervention to determine its feasibility and~          acceptability to patients. Recruitment rate, patient satisfaction, attendance,~          questionnaire completion rates and the reliability and validity of the questionnaires~          will be assessed.~        -  Conduct preliminary analyses on the efficacy of the intervention in improving patients'~          depression. Evaluate whether depression levels in patients receiving the intervention~          decreases, and whether the decrease is greater among those who complete more sessions.~        -  Test the relationship between patients' depression levels and adherence to swallowing~          rehabilitation and to dental preventive maintenance regimens.~   "
233565|NCT00498862|"~     Specific aim To examine the effect of catecholamines on the modulation of intermittent~     hypoxia induced TNF- in human monocytes from both healthy subjects and OSA patients (2). To~     map the signaling pathway of catecholamines regulating the intermittent hypoxia induced TNF-~     expression.~      (3). To explore the potential therapeutic effects of  or  agonists/antagonists on~     intermittent hypoxia induced TNF- expression~   "
233566|NCT00498849|"~     The aim of this study are (1) To genome-wide profile the gene expression patterns of~     peripheral blood mononuclear cell (PBMC) in patients with obstructive sleep apnea (OSA) (2)~     To profile the gene expression patterns change before and after treatment with continuous~     positive airway pressure (CPAP) (3) To correlate the altered gene expression with the~     severity of the disease and outcome of OSA patients~   "
233567|NCT00498836|"~     Patients with metastatic malignant melanoma will receive CP-4055 200 mg/m2/day intravenously~     (IV) on Day 1-5 every four weeks and sorafenib 400 mg b.i.d. (twice daily) every day until~     complete response or disease worsening/progressing.~   "
233568|NCT00498810|"~     To compare the complete repair of the abdominal wall at the level of the former incision with~     only a partial repair at the level of the hernia in patients with an incisional hernia after~     median laparotomy in a prospective randomized trial.~   "
233569|NCT00498797|"~     The purpose of this study is to determine whether treatment with Zactima (vandetanib) in~     combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and~     Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer~     who have not previously received chemotherapy.~   "
233570|NCT00498784|"~     The purpose of this study is to evaluate the changes in the quality of life, as well as in~     the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine~     system, over the first 12 months of use. Patients switching from oral contraception to an~     intrauterine contraceptive device (here: MIRENA) will be observed in the first year post~     MIRENA insertion.~   "
233571|NCT00498771|"~     The purpose of this study is to determine what effects aquatic exercise has on participants~     with Lymphedema.~   "
233572|NCT00498758|"~     The purpose of this study is to evaluate the benefits of a biomechanical wedge system - The~     APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's~     disease patients.~   "
233573|NCT00498745|"~     To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a~     reference capsule and an oral solution in healthy subjects.~   "
233574|NCT00498732|"~     Specific Aim~        1. To verify the differentially expressed genes and pathways between normal and OSA~          patients, and OSA patients before and after CPAP treatment.~           Genes with changes in expression of more than two-fold between normal and OSA patients~          as well as OSA patients before and after CPAP treatment were thought as confirmed and~          were selected for further validation study.~        2. To correlate the confirmed genes with the clinical presentations and CPAP effects in~          another 50 OSAS subjects to validate the altered gene expressions and pathways involved.~           To investigate the correlation of genes confirmed from RT-PCR (identified gene), another~          50 OSAS subjects are included in the study. We analyze the correlation between~          identified gene and the clinical manifestations and CPAP effect in these 50 OSAS~          patients.~        3. To establish a cell model to investigate the differentially expressed genes and the~          putative biological pathways involved in OSA syndrome.~      To investigate the functions of genes identified in the first and second year (gene of~     interest), we establish a cell model with human monocyte cell line U937. We investigate the~     function of gene of interest through overexpress or knockdown.~      Objectives The objectives of this project are to confirm the gene profiled from comparing~     normal and OSA patients as well as OSA patients before and after CPAP treatment, to~     investigate the correlation between altered gene expression and clinical presentations and~     CPAP effects of the OSAS and to identify and confirm corresponding pathway. This study will~     enhance our understanding of the individual constitution on widely different clinical~     characteristics and therapeutic variations. All these efforts will also help us to interpret~     its molecular mechanisms and develop prediction and diagnosis strategies of OSAS. The~     long-term objectives are to develop therapeutic strategy other than CPAP of OSAS.~   "
233591|NCT00498511|"~     Both upper gastrointestinal endoscopy and colonoscopy are recommended in men and~     post-menopausal women with iron deficiency anemia. Due to lack of data on the yield of these~     endoscopies in young men, they are currently investigated as older men. The aim of this study~     is to evaluate prospectively the prevalence of various gastrointestinal lesions in young men~     with iron deficiency anemia. Our hypothesis is that the diagnostic yield of colonoscopy in~     young anemic men without gastrointestinal symptoms is very low, especially if a potential~     lesion is detected during upper gastrointestinal endoscopy. Therefore, this study will try to~     identify predicting factors regarding the yield of both endoscopies. Another purpose is to~     evaluate the outcome of patients with negative endoscopic results, during a follow-up of two~     years.~   "
233671|NCT00497471|"~     The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the~     efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area~     of intense and perennial malaria transmission~   "
233575|NCT00498719|"~     Primary Objectives:~        1. To evaluate the feasibility of enrolling children and adolescents with newly diagnosed~          brain tumors, leukemia, or lymphoma in a program designed to prevent the academic and~          cognitive declines that commonly result following central nervous system (CNS) disease~          and treatment.~           Hypothesis 1: Despite the rigors of disease and treatment, children and adolescents will~          be able to participate in the CTP while they are receiving treatment for cancer. The~          high participation of our patients in routine school activities during treatment~          suggests that they will have the energy and interest required to participate in~          cognitive training.~        2. To evaluate whether a Cognitive Training Program (CTP) might be helpful to patients in~          preventing attention deficits that commonly result following CNS disease and therapy.~           Hypothesis 2: Patients in the CTP arm of the study will show fewer declines in~          neurocognitive performance at the end of training and again six months later, as~          compared with the control group who will receive the usual services provided by the~          Education Program in Pediatrics.~        3. To explore the relationship between CTP treatment compliance and stability/decline in~          cognitive and academic performance in children and adolescents who are being treated for~          brain tumors, leukemia, and lymphoma.~      Hypothesis 3: Level of compliance with CTP treatment will be predictive of a patient's~     performance on neurocognitive measures.~   "
233576|NCT00498706|"~     This study will compare the effectiveness of telephone versus face-to-face administration of~     cognitive behavioral therapy in treating people with depression.~   "
233577|NCT00498693|"~     Specific Aim~        1. To identify specific SNPs of HIF-1 gene related to cardiovascular disease in OSA~          patients (CVD-OSA)~        2. To assay the functional activity of high risk SNPs of HIF-1 on the transcription of VEGF~          gene~        3. To confirm that the serum level of VEGF in CVD-OSA patients with high risk SNPs of HIF-1~          are higher than CVD-OSA patients without~   "
233578|NCT00498680|"~     A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed~     to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive~     three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in~     different sequences of administration in such a manner that eventually each patient will~     receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by~     measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking~     half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude~     the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of~     erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for~     each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3~     groups will be performed.~   "
233579|NCT00498667|"~     A retrospective analysis will be performed regarding the usefulness of PET/CT performed~     following 2 cycle of chemotherapy in evaluation of progression, free survival and overall~     survival of patients with aggressive non Hodgkin Lymphoma.~   "
233580|NCT00498654|"~     The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine~     in healthy adult subjects.~   "
233581|NCT00498641|"~     To compare the effects of perceptual learning with patching on improving visual acuity and~     contrast sensitivity in payient with anisometropic amblyopia.~   "
233582|NCT00498628|"~     The purpose of this study is to determine whether quetiapine fumarate extended release is~     effective in the treatment of alcohol dependence in very heavy drinkers.~   "
233583|NCT00498615|"~     Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there~     is closure of the digital arteries and cutaneous arterioles leading to the clinical finding~     of sharp demarcated digital pallor and cyanosis of the distal skin of the fingers and/or~     toes. Patients often continue to experience problems despite current available treatment. The~     investigators' study will investigate the use of a new vasodilator called Fasudil, a~     Rho-kinase inhibitor. The investigators' hypothesis is that Fasudil will prevent~     vasoconstriction of digital and cutaneous arteries during a standard laboratory based cold~     exposure and will therefore improve digital blood flow and skin temperature recovery time~     following cold challenge. These data will provide the rationale for a more elaborate clinical~     trials in real life situations.~   "
233584|NCT00498602|"~     To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active~     immunization, in subjects with mild to moderate Alzheimer's disease.~   "
233585|NCT00498589|"~     -  PHASE: II~        -  TYPE OF STUDY : With direct benefit~        -  DESCRIPTIVE: Multicenter, randomized, double-blind study~        -  INCLUSION CRITERIA: Steroid-dependent ulcerative colitis~        -  OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free~          remission in steroid-dependent ulcerative colitis~        -  STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1~          intramuscular injection per week~        -  NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients~        -  INCLUSION PERIOD: 24 months~        -  STUDY DURATION: 36 months~        -  EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without~          colectomy at 16 weeks of treatment.~   "
233586|NCT00498576|"~     Recently we have shown that melatonin secretion is impaired in rats with metabolic syndrome.~     We have also demonstrated that exogenic melatonin supplementation can improve blood pressure~     profile in nondipper patients.~      The aim of this study is to find whether there is a difference between melatonin secretion in~     hypertensive kidney recipients versus normal hypertensive patients. Secondly, to ask if~     there is any correlation between melatonin secretion and adiponectin levels.~   "
233587|NCT00498563|"~     Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure)~     caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with~     degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep~     and/or post-sleep performance are affected is not known. The study hypothesis is that sleep~     and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at~     altitudes of 8,000 or less.~   "
233588|NCT00498550|"~     Many individuals with schizophrenia also suffer from marijuana addiction. Clozapine, an~     atypical antipsychotic medication, may prove useful at preventing drug relapse in~     schizophrenic individuals who are seeking treatment for marijuana addiction. The purpose of~     this study is to compare the effectiveness of clozapine, vs. treatment-as-usual with other~     oral antipsychotics at reducing marijuana use in schizophrenic individuals.~   "
233592|NCT00498498|"~     The goal of this study is to answer the following questions:~        -  What is the time course of the expected changes in endothelin levels during the first~          two weeks after injury and how does this relate to outcome?~        -  What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and~          cerebrospinal fluid and type of injury, from CT scans and GCS?~        -  What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and~          cerebrospinal fluid and outcome measurements like GOSE, ICP and CT scans?~        -  What is the relation between neurohormones related to the neutral endopeptidase (NEP)~          (ANP, BNP and cGMP) in plasma and cerebrospinal fluid and type of injury, from CT scans~          and GCS?~        -  What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and~          cerebrospinal fluid and markers for apoptosis?~   "
233593|NCT00498485|"~     Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As~     a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having~     slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce~     the sleep disturbances of CFS leading to better sleep with less fatigue. Its ability to~     produce the rapid onset of deep sleep is a reason it became a street drug, but its~     availability is currently limited via distribution through a single centralized pharmacy.~     Xyrem has been successfully used based on results from a study on patients with fibromyalgia~     (FM), an ailment closely resembling CFS. However, in that study, the researchers provided no~     information as to whether patients had FM alone or FM plus CFS. Thus, it is not clear from~     this study just which patient may be helped. I have prescribed Xyrem for patients who have~     both FM and CFS with good results. In this study, funded by the company that makes Xyrem, I~     propose testing the drug's efficacy on patients with CFS alone - that is, they do not have~     fibromyalgia.~      Volunteers for this study will complete paper and pencil questionnaires about their symptoms~     as well as a computerized test to assess their degree of brain fog. They will then be~     randomly assigned to one of two groups, placebo or drug. Volunteers will not know what group~     they are in until the end of the study. Only the drug group will receive the medication. The~     placebo group will receive a substance that looks identical to the real medicine but with no~     active ingredients. The medication comes as a liquid and patients will start taking an~     initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5~     hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will be told~     to skip taking the second dose. We will call patients weekly to see how they are doing on the~     drug. If they have tolerable side effects or report significant improvement, we will~     maintain the dose. But if patients report no effect of treatment, the dosage will be~     incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is~     reached.~   "
233594|NCT00498472|"~     Hospitalizations for acute heart failure syndromes (AHFS) are associated with a high~     rehospitalisation and mortality rate. The aim of this study is to assess if the measurement~     of NT-proBNP levels before discharge may improve the prognosis of the patients recently~     admitted to hospital for AHFS~   "
233595|NCT00498459|"~     Physical activity is thought to be a key element in preventing the obesity epidemic and the~     associated cardiovascular and metabolic diseases. However population-based studies directed~     at promoting physical activity in youth have shown limited success in obesity prevention. The~     aim of this study is to assess whether an intervention integrating socioecological changes,~     which has the potential to induce sustained changes in physical activity, prevents overweight~     and cardiovascular risk in adolescents.~   "
233596|NCT00498446|"~     An atrial septal defect (ASD) is a hole in the heart that can lead to heart failure.~     Depending on the size and severity of the ASD, They can be treated during a heart~     catheterization with a special device that can permanently seal the ASD, but knowing the~     exact size and severity of the ASD is crucial. Newer MRI techniques may provide a better way~     at diagnosing the size and severity of an ASD. We compared MRI to other standard clinical~     ways for evaluating an ASD.~   "
233597|NCT00498433|"~     Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial~     fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin~     activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren,~     amlodipine and angiotensin II concentrations, and renin activity and concentration in plasma.~      Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone~     system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle~     tissue in obese patients with hypertension in comparison to amlodipine.~   "
233598|NCT00498420|"~     The natural history study of the rare lysosomal disease alpha-mannosidosis will answer the~     question; why the rare disease develops as it does?~   "
233599|NCT00498407|"~     Patients with histologically or cytologically confirmed metastatic colorectal cancer (CRC)~     who have failed a first-line chemotherapeutic regimen containing oxaliplatin and~     5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational~     Medicinal Products (IMPs), will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5~     every four weeks until complete response or disease worsening/progressing.~   "
233600|NCT00498394|"~     This pilot study is a randomized, controlled clinical trial to compare anthropometric and~     metabolic changes associated with six months of weight management by means of a very low~     carbohydrate diet or a calorically-restricted low fat diet. We hypothesized that the low fat~     diet would be associated with more weight loss and improvement of cardiovascular risk factors~     than the low carbohydrate diet.~   "
233601|NCT00498381|"~     Aim of study:~        1. To compare the level of IL-6 mRNA expression in peripheral blood monocytes between~          normal subjects and patients with OSAS~        2. To compare the activation of NF-B in peripheral blood monocytes between control~          subjects and patients with OSAS; Check the correlation between level of L-6 mRNA~          expression and activation of NF-kB~        3. To determine the effect of CPAP on the activation of NF-kB and IL-6 in peripheral blood~          monocytes in patients with moderate –severe OSAS~   "
233602|NCT00498368|"~     This study was about IgA nephropathy, a form of kidney disease characterized by the presence~     of blood and protein in the urine. This study was done to determine if the medication~     rituximab could reduce protein in the patient's urine.~      Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg~     of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in~     reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.~   "
233631|NCT00497991|"~     The purpose of this study is to assess safety and tolerability of multiple ascending doses of~     AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with~     relapsed acute myeloid leukaemia.~   "
233632|NCT00497978|"~     The purpose of this study is to reduce the postoperative morbidity and mortality in the~     elderly hip fracture patient, by giving them taurine peri-operatively.~   "
233633|NCT00497965|"~     The purpose is to study the effect of chiropractic care on balance in older adults.~   "
233603|NCT00498355|"~     Uveitis is an inflammation (swelling and irritation) inside the eye, affecting the uvea. The~     uvea is the layer of the eye between the sclera and the retina and provides most of the blood~     supply to the retina.~      Uveitis is an important cause of visual loss. There are 30,000 new cases of legal blindness~     each year due to uveitis in the U.S. Sight-threatening complications associated with uveitis~     include macular edema, which may persist even when inflammation is controlled. The only~     current treatment for cystoid macular edema (CME) in uveitis patients is oral or regional~     steroid injections. For patients who don't respond to steroids or who are unable to tolerate~     steroid therapy, there are no other medical treatments.~      The aim of this study is to determine if ranibizumab, an FDA-approved treatment for~     neovascular age-related macular degeneration, is an effective treatment for those patients~     with uveitis-induced CME who are unable to be treated with or non-responsive to steroids.~   "
233604|NCT00498342|"~     Primary outcome: Serum creatinine change at 4 hours and 48 hours following 4 doses of~     N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine.~      Secondary outcome: Serum Cystatin C change at 4 hours and 48 hours post 4 doses of~     N-acetylcysteine compared to baseline serum Cystatin C.~   "
233605|NCT00498329|"~     This study will examine how the areas in the brain are connected when they are controlling~     two finger movements at the same time. It will look at how people use what they see to help~     guide two different movements. This ability, which is important in everyday life, can be a~     problem for patients with neurological problems.~      Healthy right-handed volunteers 18 years of age and older may be eligible for this study.~     Candidates are screened with a medical history, physical examination and magnetic resonance~     imaging (MRI) of the brain. MRI uses a strong magnetic field and radio waves to obtain images~     of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong~     magnetic field. The subject lies on a table that can slide in and out of the scanner, wearing~     earplugs to muffle loud noises that occur during the scanning.~      Participants undergo functional MRI (fMRI). This is a standard MRI that is done while the~     subject performs skilled finger tasks in response to instructions they see on a screen.~     Researchers localize brain areas which show activity changes while the tasks are performed.~     Before the test session begins, subjects complete a questionnaire and have an opportunity to~     practice the task.~      Subjects control the position of one or two cursors on a screen using one or two fingers.~     They perform tracking or pointing tasks according to what they see on the screen. During the~     single-task experiment only one task is presented on the screen. During the dual-task~     experiment, two tasks are presented on the screen. Subjects perform either the single-task or~     dual-task experiment, but not both. The fMRI lasts about 90 minutes, with subjects asked to~     lie still during the scan for up to 9 minutes at a time.~      After completing the fMRI, subjects are scheduled for a research electroencephalogram (EEG)~     and magnetoencephalogram (MEG). The test is done while the subject performs tasks so that~     researchers can learn about the timing of changes in activity in certain brain regions during~     performance of the same tasks done for the fMRI.~   "
233606|NCT00498316|"~     The goal of this clinical research study is to learn if combining cord blood units will be~     safe and result in the cells taking faster in recipients. The cord blood units will have~     their cell number increased in the lab using cells from a family member or they will be~     collected from an unrelated healthy donor.~   "
233607|NCT00498303|"~     Annual trial for registration of trivalent split influenza vaccine with the strain~     composition of the season 2007/2008 in healthy adult and elderly subjects~   "
233608|NCT00498290|"~     The purpose of this study is to determine whether ERAS is safe and can decrease surgical~     stress, increase functional recovery and reduce complication rate in colorectal surgery.~   "
233609|NCT00498277|"~     Primary Objective:~      The purpose of this study is to determine whether or not combined quantitative diffusion and~     fat MR imaging techniques can differentiate between benign and malignant vertebral fractures.~   "
233610|NCT00498264|"~     Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to~     reduced physical function and frequent use of health care services. Exercise training is~     commonly recommended as a treatment.~      The purpose of this study is to determine whether a supervised resistance muscular exercise~     (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.~      The practical of the RME reduces the pain of participants with FMS.~   "
233611|NCT00498251|"~     Background :~      Acute lung injury (ALI) occasionally occurs after pulmonary resection and carries a bad~     prognosis with a high mortality rate ranging from 20 to 100%.~      Objectives :~        1. to evaluate pre-, intra- and postoperative changes in hemodynamics, oxygenation indices~          as well as intra- and extravascular lung water using simple thermodilution technique and~          continuous arterial pressure analysis~        2. to test the efficacy of inhaled beta2 -adrenergic agonist versus anticholinergic agents~          to reduce lung edema in patients undergoing thoracic surgery and in pigs subjected to~          lipolysacharide-induced ALI.~      Design of the research protocol:~        -  Prospective controlled trial including surgical patients with high risk factors for ALI~          (n=60) allocated to receive inhaled drugs (randomised, double-blind, cross-over mode).~        -  Main measurements:~      Intra-thoracic blood volume, intra- and extra-vascular lung water, hemodynamic parameters~     (CO, systolic arterial pressure/flow variations, dPmax, MAP, CVP), oxygenation indices~     (PaO2/FIO2), ventilatory parameters, clinical outcome data, histochemical and pathological~     data.~      Glossary CO = cardiac output; dPmax = maximal arterial pressure slope; SAP-V = systolic~     arterial pressure variations; Flow–V = Flow variations; MAP = mean arterial pressure; CVP =~     central venous pressure; PaO2=arterial oxygen pressure; FIO2= oxygen inspiratory fraction~   "
233612|NCT00498238|"~     We evaluated the effect of levothyroxine in subclinical hypothyroidism (SCH) on arterial~     stiffness, lipid profile and inflammation. Thirty-four patients with SCH were included.~     Patients were treated with levothyroxine for 7 months. Arterial stiffness was evaluated by~     Augmentation index (AIx). After accomplishing euthyroidism, the AIx decreased from 8.3±17.2~     to 6.5±14.3(P<0.01) and AIx percentage decreased from36.2 11.5 ± to 9.1±33.2 (P =0.03).~     Systolic blood pressure decreased from 20±134.7 to mmHg 13.7±127.6 (P<0.01). No significant~     improvement was found in other parameters. In patients whose AIx's decreased, LDL-cholesterol~     levels decreased by 37.1±-15.5 mg/dl compared to the patients whose AIx's didn't decrease and~     LDL-cholesterol increased by 57.4±24.1 mg/dl (P=0.057). We concluded that in patients~     suffering from SCH, treatment with levothyroxine had a significant beneficial effect on~     arterial stiffness and systolic blood pressure and no effect on lipid profile or~     inflammation.~   "
233613|NCT00498225|"~     In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy~     and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using~     survival time.~   "
233614|NCT00498212|"~     The purpose of this study is to find out if a new investigational hepatitis B virus (HBV)~     vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients. Two~     dose levels will be studied: a single dose and a double dose. We expect both dose levels to~     safely immunize patients against HBV. The study will determine which dose does this best.~   "
233615|NCT00498199|"~     This study consists of two parts. The first part is a survey to examine vision-specific~     health-related quality of life in a cohort of patients with multiple sclerosis. We test~     visual impairment like visual acuity, visual field, colour discrimination, contrast~     sensitivity, eye movement. The aim of this part is to examine the association between~     responses to the quality of life scale and objective measures of visual impairment.~      The second part is an open controlled study, in which we measure motion detection threshold~     in MS patients with oscillopsia due to pendular nystagmus and in a group of control subjects.~     The objective of this part is to determine whether patients with pendular nystagmus develop~     adaptation to oscillopsia using increased threshold of motion detection. We plan to test the~     effect of visuo-motor rehabilitation on this threshold in patients with oscillopsia due to~     pendular nystagmus.~   "
233616|NCT00498186|"~     This is a multi-center, open-label extension trial conducted at the same European sites that~     participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety~     and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic~     Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will~     be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses~     and patch sizes).~   "
233617|NCT00498173|"~     This study will evaluate the effectiveness of atomoxetine in treating children with attention~     deficit hyperactivity disorder symptoms associated with autistic disorder, Asperger's~     syndrome, and pervasive developmental disorder, not otherwise specified.~   "
233618|NCT00498160|"~     The goal of this research study is to establish chimerism and avoid graft-versus-host disease~     in patients with kidney failure allowing a reduction or cessation of immune-suppressive~     therapy.~   "
233619|NCT00498147|"~     The primary objective of this study is to identify whether cardiovascular complication rates~     are lower in patients who participate in managed diabetes care, in comparison to provincial~     and national rates. This study will involve an electronic medical record (EMR) chart audit,~     augmented by a manual review of hospital and other pertinent medical records, as necessary.~   "
233620|NCT00498134|"~     Gastric cancer is the second leading cause of cancer deaths in the World. In China, gastric~     cancer exceeds all other cancer mortality except lung cancer. Helicobacter pylori infection~     is an important cause of gastric cancer. We have previously started a randomized~     placebo-controlled chemoprevention trial in Changle in 1994 to address the issue of whether~     eradication of H. pylori alone is able to prevent or reduce the risk of gastric cancer. The~     project involved 1600 subjects and is still ongoing. On the other hand, our laboratory~     research indicated that an abnormally high expression of an enzyme cyclooxygenase-2 was found~     in gastric cancer and inhibition of this enzyme by a new drug (specific cyclooxygenase-2~     inhibitor) could kill the cancer cells. The same drug is approved now for use in treatment of~     hereditary colon cancer syndrome (Familial Adenomatous Polyposis, FAP), in the same rationale~     of tumour suppressive property of this drug. We are now initiating a second chemoprevention~     study to assess the addition of this specific cyclooxygenase-2 inhibitor together with~     eradication of H. pylori on prevention or reduction of the risk of gastric cancer and to~     assess whether the combination can reverse pre-cancerous lesions in the stomach in the~     high-risk population. The proposed site is Shangdong, China with very high prevalence of~     pre-cancerous lesions in asymptomatic H. pylori carriers. We plan to recruit 1500 H. pylori~     positive subjects for this randomized placebo-controlled study. H. pylori carriers will be~     randomized to receive treatment for the infection or placebo, followed by specific COX-2~     inhibitor or placebo for 3 years. The results will have significant impact on prevention of~     gastric cancer on a national scale and worldwide.~   "
233621|NCT00498121|"~     Our aim in this study is to investigate the potential role of serum ProCT as an early~     diagnostic marker and later prognostic indicator for VAP.~   "
233622|NCT00498108|"~     This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in~     subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up~     to 1 year in subjects who previously participated in SP790 (6-month pivotal trial) or SP794~     (sleep lab trial). Subjects who successfully completed the Maintenance Period and the Taper~     Period of SP790 or SP794 are allowed to enroll in this trial.~   "
233623|NCT00498095|"~     Patients who had received kidney transplantation may suffer from rejection. Recently,~     positive staining for C4d in kidney biopsies of malfunctioning transplant kidney is~     increasingly recognized as an important prognostic indicator of poorer long-term kidney~     outcome. Data is, however, lacking in Hong Kong.~   "
233624|NCT00498082|"~     EsophyX is a promising endoscopic treatment for gastro-esophageal reflux disease. It is not~     known whether there are some pre- or per-operative anatomic or pathophysiological findings~     which may influence outcome.~      The aim of this trial is to study a series of parameters acquired during the pre-therapeutic~     work-up or during the procedure and their influence on the outcome of the procedure.~   "
233625|NCT00498069|"~     Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in~     vasculogenesis~   "
233626|NCT00498056|"~     The development of a safe and effective vaccine is the best strategy for preventing the~     spread of HIV-1. The purpose of this study is to determine the safety and effectiveness of~     and immune responses to an HIV vaccine regimen in healthy adults at risk for HIV infection.~   "
233627|NCT00498043|"~     This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18~     to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted~     IPI. The consolidation treatment is allocated according to the response to induction~     treatment assessed by PET after the 2nd and 4th induction cycles.~   "
233628|NCT00498030|"~     The purpose of this study is to identify risks that may contribute to increased insulin~     resistance which may help explain some of the increased incidence of type 2 diabetes in~     American Indian Youth, at the Rosebud reservation ages 5 to 18 years old. If specific~     positive indicators of insulin resistance are present, individuals are recruited back in one~     year for repeat of all measures.~   "
233629|NCT00498017|"~     Infections are the most feared complications developing in patient who had had kidney~     transplantation. The aim of this study is to document the local disease pattern among this~     group of patients.~   "
233630|NCT00498004|"~     The primary objective of this study is to demonstrate clinical and statistical superiority of~     quetiapine compared to risperidone in Korean version of Heinrich's Quality of Life Scale~     after 8 weeks trial of drugs.~   "
233636|NCT00497926|"~     Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell~     Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood~     elements, help fight infection and assist in clotting) and kidney transplantation from the~     same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired~     result of this study is to allow your body to develop tolerance to the transplanted kidney.~     Tolerance means that your body would see the transplanted kidney as part of you and not try~     to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must~     be taken on a daily basis. The purpose of this study is to determine if this procedure is~     safe and to try to substantially reduce or even eliminate the need for anti-rejection~     medications.~   "
233637|NCT00497913|"~     The purpose of this study is to determine whether a single injection of Dysport with a new~     protocol at forearm is effective in the management of chronic lateral epicondylitis.~   "
233638|NCT00497900|"~     Previous studies have shown high proportions of vitamin D deficiency among elderly in~     Denmark. Vitamin D is important for muscular function. The investigators intend to examine if~     it is possible to improve cardiovascular function in patients with heart failure and vitamin~     D deficiency by supplementation with vitamin D.~   "
233639|NCT00497887|"~     Atherosclerotic cardiovascular disease is the major cause of morbidity and mortality in~     Western societies. It is a complex genetic disorder with many genes involved and significant~     gene-environment interactions. The aim of the study is to identify novel genetic- and~     biological-markers of atherosclerosis. Atherosclerosis is assessed in the coronary arteries~     using coronary angiography as well as in the carotid artery (intima-media-thickness) and~     peripheral vessels (ankle brachial index). Association analysis of genetic and metabolic~     markers with atherosclerotic burden will be performed to identify novel factors of~     disposition to atherosclerotic vascular disease.~   "
233640|NCT00497874|"~     The purpose of this study is to determine whether a home-based intervention matched to stage~     of change (readiness) for using effective methods to prevent or reduce depression can improve~     depression outcomes in primary care.~   "
233641|NCT00497861|"~     This study compared the treatment effect of Activator Methods Chiropractic Technique (AMCT)~     and manual Diversified type spinal manipulative therapy in a sample of patients with acute~     and sub-acute low back pain.~   "
233642|NCT00497848|"~     The purpose of this study is to determine whether individual and/ or system orientated~     interventions can help the problem of people with schizophrenia dropping out of their drug~     treatment~   "
233643|NCT00497835|"~     An accelerometer with transmitting ability is worn on the wrist. Data of movements during~     seizures will be analyzed to upgrade algorithm that will identify seizures.~   "
233644|NCT00497822|"~     Studies have shown conflicting results of the effect of exercise on dementia patients.~      The aim of this study is to examine the role of physical activity on the risk of cognitive~     impairment and dementia in older persons.~      To promote the benefits of aerobic exercise on dementia patients and encourage exercise~     prescription in the management of dementia subjects.~   "
233645|NCT00497809|"~     The overall purpose of this study is to assess the dose response, efficacy, and safety of~     three different dose levels of AVI 014 (granulocyte colony-stimulating factor [G-CSF]) in~     breast cancer patients at high (>20%) risk for chemotherapy-induced severe neutropenia.~   "
233646|NCT00497796|"~     The purpose of this research study is to investigate whether or not oral maribavir is safe~     and effective compared to oral ganciclovir for preventing CMV disease when administered for~     up to 14 weeks in patients who have had a liver transplant.~   "
233647|NCT00497783|"~     The purpose of this study is to demonstrate the safety of the gynecological formulation in~     normal and usual usage condition of Dermacyd Femina Delicata.~   "
233648|NCT00497770|"~     This large, non-randomized observational study is being conducted to provide data about the~     impact of ethnic origin on outcomes and resource utilization during the 2nd line treatment of~     non-small cell lung cancer (NSCLC) in a routine medical care setting.~   "
233649|NCT00497757|"~     The goal of this research study is to establish chimerism and avoid graft-versus-host disease~     in patients who need a heart transplant.~   "
233650|NCT00497744|"~     Cefepime is a broad-spectrum antibiotic used in treating CAPD peritonitis. However, medical~     knowledge has been lacking with regard to its pharmacokinetic profile after it has been~     administered intraperitoneally. The current study aims at determining the drug level at~     different time after the drug has been added into the peritoneal fluid in patients with CAPD~     peritonitis. The results of this study will finally leads to rational prescription of this~     drug at correct dosages.~   "
233651|NCT00497731|"~     The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152~     when given as a continuous 2-hour infusion every week and every 2 weeks in patients with~     advanced solid malignancies.~   "
233652|NCT00497718|"~     The effect of chiropractic manipulation on spine-related pain and balance in older adults.~   "
233653|NCT00497705|"~     This study will investigate Ebstein's anomaly, a congenital abnormality of the tricuspid~     valve of the heart and try to identify the genetic origins of the disease.~      Adults and children 2 years of age and older with Ebstein's anomaly and healthy volunteers~     may be eligible for this study. Participants undergo the following procedures:~        -  Blood tests: Three tube of blood will be collected, with the total amount limited to~          about half a teaspon for each two pounds of body weight.~        -  Saliva sample collection: A small amount of saliva is collected by spitting into a~          sterile container.~        -  Oral (cheek) swab: Cells are collected from the mouth using a soft brush to swab the~          inside lining of the cheek.~        -  Electrocardiogram: The electrical activity of the heart is recorded using electrodes~          placed on the chest.~        -  Echocardiogram: Heart function is assessed using ultrasound.~   "
233654|NCT00497692|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the~     product Dermacyd Femina Delicata.~   "
233655|NCT00497679|"~     The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152~     when given as a continuous 7-day infusion every week and every 2 weeks in patients with~     advanced solid malignancies.~   "
233672|NCT00497458|"~     The purpose of this study is to evaluate whether increasing blood levels of androgen can~     reduce some of the side-effects of anti-estrogen therapy (Arimidex)~   "
233656|NCT00497666|"~     Recent data show that Rosiglitazone treatment can reduce proteinuria in diabetic patients.~     However, currently there are no trials that examine the effects of Rosiglitazone on kidney~     disease progression, that is, doubling of serum creatinine or time to onset of end-stage~     renal disease, in patients with diabetic nephropathy.~      We decided to study retrospectively the possible association between rosiglitazone use and~     clinical course of diabetic nephropathy, including rate of deterioration of renal function,~     appearance and progression of microalbuminuria/proteinuria, survival and acceptance to renal~     replacement therapy.~   "
233657|NCT00497653|"~     To determine if oral DCI administration to women with PCOS increases the total DCI content in~     urine and blood, and, if so, if that change is accompanied by i) an increase in DCI-IPG~     release in blood (as determined by bioactivity) during an oral glucose challenge and ii) an~     increase in whole-body insulin sensitivity.~   "
233658|NCT00497640|"~     The purpose of the study is to determine the validity of the prediction model in reducing the~     rate of CPAP titration failure and in achieving a shorter time to optimal pressure~   "
233659|NCT00497627|"~     Follow up of debanding patients~   "
233660|NCT00497614|"~     Biologics are routinely used for the treatment of rheumatoid arthritis (RA). Adalimumab is a~     human monoclonal antibody that inhibit the Tumor Necrosis Factor alpha (TNF-alpha).~     Identification of RA patients who respond to biologics is a challenging goal to avoid~     unnecessarily, costly and potentially harmful treatment.~      The aim of the study is to address if 18 F FDG is a valuable biomarker for the assessment of~     the clinical response in RA with TNF-alpha blocking agent. Eight patients fulfilling the ACR~     (American College of Rheumatology) criteria will by enrolled. Patient will receive adalimumab~     according to the current guidelines i.e. 40mg /14 days sub cutaneously. The decision will~     stand on a high activity of the disease defined by the DAS 28 (Disease Activity Score) above~     5.1. Positron emission tomography will be performed before, 2 and 12 weeks after the begin of~     the treatment. The response to adalimumab will by assessed by the SUV (standard Unit value)~     measured on the inflammatory joints of hands, wrist, ankle, feet and knees and compared to~     measurement of clinical (total swollen and tender joints count) echographic (synovium~     thickness and power doppler) and chemical biomarkers (erythrocyte sedimentation rate, C~     reactive protein).~   "
233661|NCT00497601|"~     The purpose of this study is:~        1. To evaluate the Safety and Efficacy of four different short-course regimens of~          Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who~          are either treatment naive or treatment resistant to other antileishmanial drugs except~          amphotericin B containing preparations.~        2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in~          treatment of Kala-azar.~   "
233662|NCT00497588|"~     early laryngeal cancer is a well known field with great controversy in treatment. two options~     are available in treatment of patients the first one is partial laryngectomy and the second~     one is radiotherapy.one of major concern of patients have been the quality of voice ,so we~     design this trial to answer the priority of each options.~   "
233663|NCT00497575|"~     Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism~     has been seldom reported. The purpose of this study was to explore the diagnostic criteria~     for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow~     up for infants with subclinical hypothyroidism ，and evaluate the curative effect.~   "
233664|NCT00497562|"~     There are evidences of functional growth hormone (GH) deficiency, expressed by means of low~     serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients.~     The efficacy of low GH doses versus placebo has been demonstrated in this population. We~     assessed the efficacy and safety of GH added to standard therapy compared to standard therapy~     alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low~     IGF-1 levels.~   "
233665|NCT00497549|"~     Carcinoma esophagus is a common cause of dysphagia. Once dysphagia occurs, a majority of the~     tumours are advanced. Most of them would require some form of treatments for control of~     dysphagia and to improve the quality of life. Surgery is the only hope for cure. It requires~     complete removal of the esophagus. After removal of the esophagus, the stomach can be used as~     a substitute for the esophagus. Anastomosis can be done in the neck either by a hand-sewn or~     by a stapled anastomosis. The anastomotic leak rates reported in studies comparing hand-sewn~     with stapled anastomosis are variable. Many non-randomized studies have reported leak rate as~     low as 5% with stapled technique. However, the stricture rate is higher in the stapled group.~     There is no randomized study comparing hand-sewn anastomosis with side-to-side stapled~     anastomosis. Hence, the investigators planned a randomized trial comparing the anastomotic~     sequelae after hand-sewn anastomosis with stapled anastomosis in the neck.~   "
233666|NCT00497536|"~     The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per~     hour compared with multiple boluses per hour.~      The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion~     (CSII) versus continuous intravenous insulin infusion (CIII).~   "
233667|NCT00497523|"~     To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation,~     compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young~     children with persistent symptoms of asthma.~   "
233668|NCT00497510|"~     To study the effect of chiropractic care and a specific exercise program on balance in older~     adults.~   "
233669|NCT00497497|"~     This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if~     PRO95780 in combination with two different irinotecan-containing regimens is safe and~     tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following,~     or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and~     bevacizumab-containing regimens. This study will also make a preliminary assessment of the~     anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI~     regimen plus bevacizumab.~   "
233670|NCT00497484|"~     We have recently demonstrated resistance to GHRH leading to GH deficiency in patients with~     Pseudohypoparathyroidism type Ia (Mantovani et al., J Clin Endocrinol Metab, 2003. 88:~     4070-4074). The purpose of this study is to evaluate the effect of at least 1-year GH~     replacement in these patients. In particular, we will focus our attention on growth velocity~     in children affected with this disease.~   "
233673|NCT00497445|"~     The objective of this study is to investigate what the value is of SET after a radiological~     or surgical intervention for peripheral arterial disease in the aorto-iliacal,~     femoro-popliteal and crural segments in comparison with a control group.~   "
233674|NCT00497432|"~     The primary purpose of this study is to assess whether hyperbaric oxygen treatment improves~     neurological function in patients who exhibit white matter hyperintensities on MRI~     examination.~      The secondary goal of this study is to determine if it is possible using MRI to discern a~     difference in perfusion of central nervous system tissue in regions of white matter~     hyperintensities after hyperbaric oxygen administration as compared to hyperbaric air.~   "
233675|NCT00497419|"~     Reperfusion delay in STEMI has been shown to be excessive in our community. In order to~     improve delay a fast track (direct transfer in catheterization laboratory) has been~     implemented. The present study aims at evaluating the benefits of this procedure.~   "
233676|NCT00497406|"~     A study for head and neck cancer patients to evaluate the feasibility of combining salivary~     gland transfer surgical procedure and IMRT helical tomotherapy to reduce dryness of mouth.~   "
233677|NCT00497393|"~     This randomized controlled trial will introduce a Clinical Decision Unit (CDU) into the~     University of Alberta Hospital Emergency Department(ED)and assess the influence on ED length~     of stay, patients who leave without being seen, and other ED Overcrowding outcomes.~   "
233678|NCT00497380|"~     Muscle catabolism is a major problem in cancer patients undergoing surgery as it negatively~     affects post-operative recovery. Recent evidence exists that protein metabolic changes are~     already apparent in cancer before muscle wasting is being present. In line, patients with~     breast cancer, generally characterized by a normal nutritional status, were recently found to~     be arginine deficient. Arginine deficiency in cancer can be explained by: 1) Reduced arginine~     availability, due to exhaustion of endogenous (muscle) sources of arginine 2) Enhanced~     arginine catabolism, due to conversion of arginine by arginase, which is abundant in tumors.~     Protein is the most important endogenous source of arginine. Arginine deficiency will lead to~     a negative feedback loop in cachexia by promoting protein breakdown in an attempt to restore~     plasma arginine levels. We hypothesize that pre-operative arginine supplementation in breast~     cancer patients diminishes the occurrence of muscle wasting after surgery by 1) normalizing~     arginine availability pre-operatively, resulting in conservation of protein, 2) diminishing~     the catabolic effects of surgery by supplying exogenous arginine for the post-operative~     response, 3) enhancing the anabolic capacity to feeding through supplying substrate for~     protein synthesis.~   "
233679|NCT00497367|"~     The purpose of this study is to determine the safety and feasibility of use in humans of the~     TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System in the treatment of de novo~     lesions in native coronary arteries involving a major side branch. The TAXUS® Petal™ is an~     investigational device with an indication of improving coronary artery luminal diameter while~     maintaining side branch access in subjects with symptomatic ischemic disease due to discrete~     atherosclerotic bifurcation lesions~   "
233680|NCT00497354|"~     Peripheral nerve blocks provide many advantages for patients (excellent pain control and~     reduction in nausea) undergoing upper and lower limb surgery however several commonly~     occurring complications can produce annoying but sometimes serious adverse effects. The~     interscalene brachial plexus block (ISBPB) is one such technique, commonly performed for~     shoulder surgery, but also produces paralysis of the diaphragm, Horner's syndrome and~     sometimes vocal cord paralysis with standard volumes of local anesthetic. This threat of~     these side effects limits the use of ISBPB in many patients who would particularly benefit~     e.g. patients with lung disease. Recently the use of ultrasound guidance is allowing~     practitioners to place smaller volumes of local anesthetic with much greater accuracy. This~     can potentially avoid anesthetizing important adjacent nerves to the target structure. If~     ultrasound-guided techniques with smaller volumes of local anesthetic could be demonstrated~     to reduce the incidence of complications without reducing effectiveness this would be very~     beneficial for patients.This will be the first randomized, double blind study to evaluate if~     an ultrasound-guided ISBPB with low volumes of local anesthetic can reduce complications for~     patients whilst maintaining quality of anesthesia and pain relief in the intra-operative and~     postoperative period.~   "
233681|NCT00497341|"~     Knee prosthesis infection is a severe complication. The use of a tourniquet during surgery~     impairs the efficacy of the antibiotic prophylaxis. We hypothesize that the antibiotic~     administration before tourniquet release decrease the infection rate. Methods: patients who~     undergo a total knee arthroplasty will be randomized to receive one of the following regimens~     of antibiotic prophylaxis:Standard: cefuroxime 1.5 g i.v. 10 min before tourniquet + placebo~     10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical~     wound.Experimental: cefuroxime 1.5 g i.v. 10 min before tourniquet + cefuroxime 1.5 g i.v. 10~     min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.~   "
233682|NCT00497328|"~     This is a randomised controlled trial to investigate the efficacy of preventive regimen of~     hydration with high dose oral N-acetylcysteine and intravenous sodium bicarbonate~     pretreatment in patients with stable advanced renal insufficiency (CKD stage 3 and 4:GFR~     15-60ml/min/1.73m2 calculated by Modification of Diet in Renal Disease Study equation (MDRD~     formula)) undergoing elective percutaneous coronary intervention (PCI).~   "
233683|NCT00497315|"~     The aim of this study is to evaluate if the multi modality treatment pemetrexed combined with~     cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect~     profile in patients with locally advanced NSCLC. Patients will be randomized between 3 cycles~     of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent~     chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy.~   "
233696|NCT00497146|"~     To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48~     weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular~     hypertrophy (LVH).~   "
233710|NCT00496964|"~     The purpose of this study is to determine whether the use of botulinum toxin A injected into~     the lateral thigh muscle improves knee function and reduces knee pain secondary to~     patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises~     will be superior to specific exercises alone in improving knee function and reducing knee~     pain in individuals with patellofemoral syndrome.~   "
233684|NCT00497302|"~     For the past several years our research program has developed and tested an intensive~     outpatient intervention that is based in social learning theory and employs abstinence~     contingent access to recovery housing as a routine aspect of an intensive day treatment~     counseling program. The present project proposes to extend this treatment intervention to the~     special population of pregnant drug using women enrolled at the Center for Addiction and~     Pregnancy (CAP). We will compare an enhanced treatment that includes abstinence contingent~     recovery house living plus intensive individual therapy, to standard care at the CAP program.~     Specific aims of the project are derived from testing a two-group design are described below:~        1. To determine whether financially supported abstinence-contingent recovery house~          placement plus individual counseling in pregnant drug-dependent women improves prenatal~          outpatient treatment retention.~        2. To determine whether financially supported abstinence-contingent recovery house~          placement plus individual counseling in pregnant drug-dependent women reduces prenatal~          drug use.~        3. To determine whether financially supported abstinence-contingent recovery house~          placement plus individual counseling results in better maternal and infant clinical~          birth outcomes (e.g., birth weight, estimated gestational age (EGA) at delivery, medical~          complications).~   "
233685|NCT00497289|"~     The study shall provide evidence for the save and efficient use of a fish oil containing~     lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by~     monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed~     by monitoring of inflammatory parameters.~   "
233686|NCT00497276|"~     The most useful method to manage pain after major foot and ankle surgery is infusion of local~     anesthetic with a catheter close to the sciatic nerve in the popliteal space above the knee~     joint.~      Inaccurate catheter placement and spread of local anesthetic account for most failures.~      The most prevalent method to place the catheter is the traditional nerve stimulation~     technique relying on surface anatomic landmarks and electrical stimulation to localize the~     sciatic nerve. In recent years ultrasound technique has been applied to provide real-time,~     visual guidance of catheter placement.~      The purpose of this randomized, controlled trial is to compare the success rate, patient~     acceptance and cost-effectiveness of the ultrasound and nerve stimulation techniques.~   "
233687|NCT00497263|"~     the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device~     in the creation of colorectal anastomosis~   "
233688|NCT00497250|"~     The primary objective of this study is to evaluate the tolerability and the maximum tolerated~     dose of Conformal or Intensity-Modulated Radiotherapy when given in combination with~     gefitinib 250mg in Chinese patients with IIIB or IV NSCLC after failure of platinum-based~     chemotherapy.~      Secondary objectives of the study are to obtain the preliminary information on efficacy after~     concomitant treatment of gefitinib 250mg and radiotherapy in Chinese patients with IIIB or IV~     NSCLC after failure of platinum-based chemotherapy, as measured by RECIST criteria.~      To determine the pattern of failure (e.g., local, regional, or distant metastasis) in~     patients treated with this regimen.~   "
233689|NCT00497237|"~     Asthma is a serious global health problem. People of all ages in countries throughout the~     world are affected by this chronic airway disorder that can be severe and sometimes fatal.~     The prevalence of asthma is increasing everywhere, especially among children.According to~     international guidelines, once control of asthma is achieved and maintained for at least 3~     months, a gradual reduction of the maintenance therapy should be tried in order to identify~     the minimum therapy required to maintain control. This will help reduce the risk of side~     effects and enhance patient adherence to the treatment plan.~      Reduction of therapy in patients on combination therapy should begin with a reduction in the~     dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients~     with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped~     down. Stepping-down will be attempted with two medications: a new combination of extrafine~     beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and,~     alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference~     medication) without losing asthma control.If this hypothesis will be confirmed, the present~     study will demonstrate that asthma control can be maintained with less than half the dose of~     inhaled corticosteroid and with less medical costs.~      Given the aims of this study, the population to be monitored includes adult patients with~     moderate persistent asthma, which can be defined controlled according to the current~     guidelines under standard stabilised treatment. The intended treatment duration is therefore~     designed to ensure that good control of asthma is firmly achieved before stepping down the~     treatment (8 weeks run-in period), but also that the condition of the patients are followed~     long enough (24 weeks comparative treatment period) to ensure that a new stable condition is~     also obtained and properly monitored.~   "
233690|NCT00497224|"~     This is an open-label, multi-center phase II study of erlotinib in patients with metastatic~     or locally advanced, unresectable pancreatic cancer who have received up to one line of~     gemcitabine based chemotherapy.~   "
233691|NCT00497211|"~     Large acute myocardial infarctions are the most frequent cause of subsequent systolic heart~     failure. Some evidence exists on the improvement after intracoronary administration of bone~     marrow cells in patients with a recente acute myocardial infarction. Although subgroup~     analyses suggest that patients with the largest myocardial infarctions have the largest~     increase in ejection fraction after intracoronary bone marrow administration, there is no~     published trial including only large myocardial infarctions. Therefor we sought to confirm~     the subgroup analyses by conducting a trial in only large first acute myocardial infarction~     patients.~   "
233692|NCT00497198|"~     The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2~     Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks~     administration in double-blind, placebo-controlled manner. And in addition, the changes in~     lipid-related parameters are examined.~   "
233693|NCT00497185|"~     The aim of the study is to examine the efficacy of Mindfulness-Based Cognitive Therapy (MBCT)~     in patients with functional disorders defined as severe Bodily Distress Disorder.~      Hypothesis: MBCT can ameliorate the symptoms of FD defined as severe Bodily Distress Disorder~     and decrease health care utilization beyond the effect of shared care. Patients treated with~     MBCT will function better physically and socially than patients treated with shared care at~     12 months' follow-up.~   "
233694|NCT00497172|"~     The main objective of this study is to assess the safety and effectiveness of the~     Sirolimus-eluting stent CYPHERTM and/or updated version in reducing angiographic in-stent~     late loss in de novo native coronary lesions of diabetic patients as compared to the bare~     metal Bx SONIC balloon-expandable stent.~      The secondary objective is to assess cost-effectiveness expressed in incremental cost/life~     year gained or cost/quality adjusted life year gained at different time points (8 months, 1~     year).~   "
233695|NCT00497159|"~     This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon~     in improving cognitive, motor, and overall function in subjects with Huntington's Disease.~   "
233697|NCT00497133|"~     Glucagon-like peptide 1 is known to improve sensitivity of the pancreatic beta-cell. Further~     it inhibit secretion from the pancreatic alpha-cell by mechanisms not fully understand. With~     this study we wish to elucidate the potential of GLP-1 to increase the sensitivity of the~     alpha-cell.~      Type 2 diabetic patients and control subjects receive infusions of GLP-1 in increasing doses~     or saline, alpha- and beta-cell responses are measured in blood-samples. During the study~     plasma-glucose levels are clamped at fasting levels.~      With this study we hope to elucidate the pathophysiology behind defect glucose tolerance in~     type 2 diabetes mellitus and further more the potential of GLP-1 in treatment of type 2~     diabetes mellitus.~   "
233698|NCT00497120|"~     The aim of the study is to investigate wether the adjuvant (postoperative) administration of~     acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients~     with mild sleep apnea.~   "
233699|NCT00497107|"~     The purpose of this study is to conduct a randomised controlled trial (RCT) comparing UFT/LV~     and UFT/LV + PSK in patients with histological stage IIIa/IIIb colorectal cancer who have~     undergone curative surgery without residual cancer using 3-year disease free survival (DFS)~     as the primary endpoint, and also to analyze the 3-year overall survival (OS), compliance,~     adverse events, quality of life (QOL) and relationship with tumor factors.~   "
233700|NCT00497094|"~     Background. Carotid artery stenting (CAS) recently has become an accepted method for~     treatment of patients with high-grade carotid artery stenosis, who are at an increased risk~     for surgical carotid endarterectomy (CEA). The reported rates of neurological complications~     of CAS substantially decreased during the past years, and the routine use of cerebral~     protection devices and low profile catheter systems have further increased the procedure´s~     safety. In the early 90's large surgical trials in North America and Europe (NASCET, ECST and~     ACAS) demonstrated superiority of CEA compared to best medical treatment for symptomatic and~     asymptomatic patients. Provided that the ongoing randomized controlled trials comparing CAS~     and CEA confirm equivalence between the these methods, CAS similar to CEA is applicable to~     symptomatic and asymptomatic patients with high grade carotid stenosis. However, particularly~     in asymptomatic patients, the indication for revascularisation remains debatable. Protected~     CAS is associated with a very low rate of neurological complications, which are below the AHA~     recommendation for treating asymptomatic patients (3%). However, the introduction of new~     vascular protective medications like statins and clopidogrel during the recent years~     substantially improved the spectrum of best medical treatment, and the findings of NASCET,~     ECST and ACAS with respect to best medical treatment may therefore not be applicable any~     more.~      Study hypothesis and aims. Given the low frequency of spontaneous neurological complications,~     the preferable therapeutic approach to patients with asymptomatic high grade ( > 80%) carotid~     artery stenoses is currently unknown. Modern best medical treatment may manage to stabilize~     the atherosclerotic plaque, while CAS has the potential of resolving the carotid stenosis.~     Comparative data, however, are not available as yet. We hypothesized that protected CAS has a~     beneficial effect on occurrence of ipsilateral neurological complications and major adverse~     cardiac events in high-risk patients with asymptomatic > 80% internal carotid artery~     stenosis. Therefore, the aim of the present randomized controlled trial was to analyze~     neurological and cardiovascular outcome of patients treated with elective CAS plus best~     medical treatment compared to best medical treatment only.~   "
233701|NCT00497081|"~     Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual~     behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or~     acquiring HIV. This study of intermediate size (60 participants) and length (3 months of~     follow-up) will assess the efficacy of mirtazapine in reducing methamphetamine use among~     high-risk MSM.~   "
233702|NCT00497068|"~     The primary objective of the proposed study is to evaluate the efficacy of tobacco~     abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives~     for reducing or eliminating tobacco use during pregnancy in methadone treated women. In~     addition, the impact that this intervention has in reducing the incidence and severity of~     methadone associated neonatal abstinence syndrome will also be examined.~   "
233703|NCT00497055|"~     Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual~     behavior among men who have sex with men (MSM), putting meth-using MSM at extraordinarily~     high risk for transmitting or acquiring HIV. This study is a randomized, double-blind,~     placebo-controlled trial of the medication aripiprazole for methamphetamine-using~     individuals, including MSM, and will assess efficacy, acceptability, tolerability, safety,~     and adherence to study medication.~   "
233704|NCT00497042|"~     The study’s primary goal is to assess the safety of the SAF (Self Adjusting File) device for~     root canal treatments.~      The study’s secondary goal is to evaluate the effectiveness of the SAF device for root canal~     treatments~   "
233705|NCT00497029|"~     This purpose of this study was to evaluate effectiveness of a risk-based dental caries~     prevention program conducted by dental personnel at an urban pediatric primary care clinic~     serving largely low-income residents of Baltimore, Maryland, and to appraise this program as~     a model for similar urban pediatric settings.~   "
233706|NCT00497016|"~     A number of patients with hypertension have increased central sympathetic activity. Statins~     seem to inhibit central sympathetic output. This study assesses the effect of statins on~     central sympathetic activity in hypertension patients.~   "
233707|NCT00497003|"~     The aim of this study is to evaluate the effect of the two different beta blockers metoprolol~     and carvedilol on endothelial function in patients with either type two diabetes or chronic~     heart failure.~      Hypothesis: 1* Carvedilol compared to metoprolol has a favourable effect on endothelial~     function.~      2* Carvedilol compared to metoprolol has a favourable effect on insulin stimulated~     endothelial function.~      The study is conducted as an open parallel group study. Endothelial function and insulin~     stimulated endothelial function was evaluated before and after a two months treatment period~     with either of the two beta blockers.~   "
233708|NCT00496990|"~     This is a two group randomized design that will compare a novel therapy package (i.e.,~     Research supported treatment intervention, Contingency-based voucher incentives for the male~     partner's drug abstinence, Specialized MI couples counseling) to standard care for helping~     drug using partners of drug dependent pregnant women obtain and maintain drug abstinence.~     Participants will be followed for 22 weeks and have scheduled twice weekly urine sample~     collection and all participants will have follow-up interviews post-study entry.~   "
233709|NCT00496977|"~     The trial is a randomised trial comparing annual CT screening for lung cancer with no~     screening in 4104 smokers and former smokers between the age of 50 and 70 years. The goals~     are: 1) to evaluate if annual CT screening can reduce lung cancer mortality by more than 20 %~     (in collaboration with the NELSON trial in the Netherlands, 2) to evaluate psychological~     effects of screening including the effects of false positive diagnoses, and 3) to evaluate~     possible effects on smoking behaviour. The trial is funded in full by the Danish Ministry of~     Interior and Health.~   "
233764|NCT00496236|"~     This study is looking at the safety and tolerability of TNFeradeä Biologic combined with~     conventional once daily radiation therapy in elderly or frail patients with new onset locally~     advanced head and neck tumors.~   "
233711|NCT00496951|"~     Symptoms of Neonatal Abstinence Syndrome (NAS) can be attributed largely to dysfunction of~     the autonomic nervous system in opiate exposed neonates. Vagal tone is a readily available~     measure of autonomic nervous system functioning. NAS is a widely variable disorder with~     poorly understood pathophysiology; while all opiate exposed infants will exhibit some signs~     and symptoms of NAS, only approximately ½ have severe enough symptoms to require~     pharmacologic therapy. This research seeks to determine the relationship between infant vagal~     tone and NAS severity. The determination of a link between newborn vagal tone and NAS~     severity could result in the prediction of infants at risk for severe NAS and provide these~     infants and mothers with intensified services and early treatment, thereby shortening the~     course of NAS in the infant.~   "
233712|NCT00496938|"~     The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus~     Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on~     clinical outcomes in the treatment of female patients with de novo coronary artery lesions,~     and the characterization of the female population undergoing stent implantation with a XIENCE~     stent.~   "
233713|NCT00496925|"~     We examine the usage of Dopamine blockers in OCD patients. We want to examine their frequency~     of usage, compare the course of the disease between those who receive and those who do not~     receive Dopamine blockers, and efficacy of the treatment.~      The study will be done in two stages: 1. Collecting information the usage of Dopamine~     blockers from 150 OCD patients' files. 2. interviewing 60-70 patients to see the difference~     those who receive and those who do not receive Dopamine blockers in their current severity of~     disease.~   "
233714|NCT00496899|"~     The study is an open label feasibility study. The purpose of the study is to evaluate the~     ease of use of the Cervical ITR in terms of duration of attachment and number of detachments.~   "
233715|NCT00496886|"~     Fibromyalgia (FM) is a disabling chronic disorder characterized by widespread muscle pain,~     fatigue, and multiple tender points, specific places on the body that become painful with~     only slight pressure. Pain associated with FM cannot be explained medically, often leading to~     a delayed diagnosis and delayed treatment. The purpose of this study is to evaluate how the~     nervous system, specifically the brain, processes pain in women with FM.~   "
233716|NCT00496873|"~     The goal of the clinical research study is to learn if treatment with a combination of three~     drugs, Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin), will help to~     control the disease in patients with previously untreated non-Hodgkin's lymphoma, CLL, or~     bulky lymphoma. The safety of this treatment will also be studied.~   "
233717|NCT00496860|"~     This is a Phase 1, open-labeled, non-randomized, multi-center, competitive enrollment and~     dose-escalation study of ALT-801, the study drug. The purpose of this study is to evaluate~     the safety, determine the maximum-tolerated dose (MTD) and characterize the pharmacokinetic~     profile of ALT-801 in previously treated patients with progressive metastatic malignancies.~     ALT-801, a recombinant fusion protein with a interleukin-2 (IL-2) component, has a targeting~     mechanism that recognizes tumor cells with a specific tumor marker.~   "
233718|NCT00496847|"~     PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal~     defects. This study will test the safety and efficacy of PERIOGEN in the treatment of~     periodontal disease~   "
233719|NCT00496834|"~     The primary objective of this study is to evaluate efficacy, arterial stiffness measured by~     Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24~     weeks of treatment in patients with the essential hypertension.~   "
233720|NCT00496821|"~     The purpose of this study is to determine the safety, tolerability and efficacy of intranasal~     ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers~     experimentally inoculated with RSV~   "
233721|NCT00496808|"~     Primary Objectives:~        -  To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation~          rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS)~        -  To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu~          over-expressing DCIS~   "
233722|NCT00496795|"~     Molecular markers predicting response to dose dense chemotherapy with epirubicin and~     docetaxel in sequence for locally advanced breast cancer~      Protocol summary.~      Principal Investigator Per E Lonning, Professor, Section of Oncology, Department of Medicine~      Collaborators. Dept of Surgery - Responsible: Turid Aas, Consultant Surgeon Dept of Molecular~     Biology - Responsible: Professor Johan Lillehaug Dept of Anatomy and Cellular Biology -~     Responsible: Professor Rolf Bjerkvig~      Participants. Dept of Oncology Gun Anker, Consultant Oncologist Stephanie Geisler, Consultant~     Oncologist Jurgen Geisler, Consultant Oncologist~      Type of Study Phase II, Translational research~      Scientific aims: Addressing factors predicting response to dose intensive epirubicin followed~     by docetaxel sequential therapy~      Treatment regimen: epirubicin 60 mg/m2 on a 2 weekly basis x 4 followed by docetaxel 100~     mg/m2 2-weekly x 4.~      Patients: Breast cancer patients below 65 years of age suffering from large (>4 cm largest~     diameter, non-inflammatory and / or N2-N3) primary breast cancer.~      Clinical aim: Assessing responsiveness to this dose intensive regimen.~      Number of patients to be enrolled: 60 - 100~   "
233723|NCT00496782|"~     The purpose of this pilot study is to determine whether there is a correlation between viral~     load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a~     failing regimen, and the R5 result of the TrofileTM assay at screening.~   "
233724|NCT00496769|"~     The purpose of this clinical research study is to determine whether apixaban is more~     effective than acetylsalicylic acid in the prevention of strokes associated with patients~     with atrial fibrillation. The safety of this treatment will also be studied.~   "
233725|NCT00496756|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in~     treating patients with metastatic or unresectable kidney cancer.~   "
233726|NCT00496743|"~     The purpise of this study was to determine the effect of low-dose (4 Gy) total skin electron~     beam therapy as a second-line treatment of stage IB-II mycosis fungoides.~   "
233727|NCT00496730|"~     Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting~     on such increasing populations like metabolic syndrome patients with Vytorin® in korea.~     Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian~     population with metabolic syndrome.~   "
233728|NCT00496717|"~     Calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. The aim~     of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal~     fast scan and to correlate this measurement with classical cardiovascular risk factors and~     newer parameters reflecting vascular rigidity, like pulse velocity measurement.~   "
233729|NCT00496704|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, capecitabine, and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when~     given together with capecitabine and oxaliplatin as second-line therapy and to see how well~     it works in treating patients with advanced colorectal cancer previously treated with~     irinotecan.~   "
233730|NCT00496691|"~     This 4-year competing continuation will extend the follow-up for 750 subjects enrolled in a~     randomized interventions trial, Project STYLE: HIV Prevention for Youth with Severe Mental~     Illness (R01, MH 63008). Extending the follow-up from one year to 36 months will 1) discern~     the long-term impact of the Project STYLE interventions and 2) permit complex modeling of the~     predictors and trajectories of sexual health (delay of sex) and risk (incident STIs).~     Adolescents, particularly those in mental health treatment, are at risk for HIV because of~     sexual and substance behaviors. Parent-child communication about sexual topics and parental~     supervision are associated with delays in the onset of sexual activity and more responsible~     sexual behavior; thus, the parent project, Project STYLE, is a randomized trial that is~     evaluating the comparative efficacy of three interventions: a) family-based HIV prevention~     intervention, b) adolescent-only HIV prevention intervention, and c) general health promotion~     intervention. This multi-site project (Rhode Island Hospital, Emory University, and the~     University of Illinois at Chicago) is enrolling an ethnically/racially/geographically diverse~     group of 750 adolescents in outpatient mental health treatment and their parents. Subjects~     receive a full day group intervention on the day of randomization, return in two weeks for an~     individual session, participate in a half day booster session three months later, and are~     assessed six and 12 months after the intervention. This application offers a unique~     opportunity to assess this already ascertained sample at three additional points (24,30, and~     36 months). This is important because few studies have examined the longer-term predictors of~     the delay of sex and incident STIs over 36 months using a comprehensive array of family~     functioning, family monitoring/communication, and trauma history. Additionally, this~     continuation will provide important data concerning the long-term impact of Project STYLE's~     theoretically based HIV prevention programs which are designed to maintain safe sexual~     behaviors. The Family-Based program has increased parent/adolescent sexual communication and~     reduced adolescent unprotected sex after six months and extended assessment will determine~     whether these benefits are maintained over time.~   "
233731|NCT00496678|"~     The University of Rochester, Department of Family Medicine, funded by the National Cancer~     Institute will train community health workers to guide patients through the cancer care~     system. The project will help to teach patients how to communicate more effectively with~     their health care team in order to understand the treatment options available to them.~     Although not widely available, it is believed patient navigation programs are beneficial.~      This research study will evaluate how well this tool works, especially among those who~     experience disparities in health care. The goal is to determine if having a trained navigator~     shortens the time between an abnormal test result and a definitive diagnosis and between a~     definitive diagnosis and completion of treatment for breast and colorectal cancer patients.~     The project also will evaluate whether navigation improves the ability to communicate with~     the doctor, patient satisfaction with care and quality of life.~   "
233732|NCT00496665|"~     The purpose of this research study is to determine the safety and tolerability of the~     combination of Zactima with metronomic chemotherapy. Zactima is an oral anti-angiogenesis~     drug, which means it fights cancer by cutting off a tumor's blood supply. Thus, the drug~     starves the tumor by preventing the delivery of nutrients and oxygen. Metronomic chemotherapy~     is low dose oral chemotherapy pills which are taken daily. Unlike traditional chemotherapy,~     metronomic chemotherapy is thought to fight cancer like Zactima, by cutting off the blood~     supply to tumors. Because the dose is very low, the side effects are generally mild and very~     different from those with higher dose chemotherapy given by vein.~   "
233733|NCT00496652|"~     The purpose of this study is to determine whether the addition of the fully human EGFr~     antibody zalutumumab to primary curative radiotherapy increases locoregional control in~     Squamous Cell Carcinomas of the Head and Neck.~   "
233734|NCT00496639|"~     Arteriovenous grafts are used as the vascular access in 40-50% of hemodialysis patients.~     Grafts are prone to recurrent stenosis (narrowing) and thrombosis (clotting). Graft clotting~     is usually due to a narrowing at the site where the graft joins the vein. The standard~     treatment is to remove the clot and angioplasty the narrowed area. The long-term outcome is~     not good, lasting only about 1 month. Placing a stent (a small metallic, PTFE covered,~     spring) at the narrowed site may keep the graft open longer. Principal investigator's~     preliminary research data suggest that placing a stent at the stenotic site prolongs graft~     patency following thrombectomy, as compared to conventional angioplasty.~      This is a single-center, randomized clinical trial, in which patients with a clotted graft~     with underlying stenosis at the venous anastomosis of the graft will be allocated to~     thrombectomy + angioplasty (control group) or to thrombectomy + stent placement (study~     group). The primary endpoint will be primary (unassisted) graft patency. The secondary~     endpoints will be secondary (assisted) graft patency and overall access-related costs.~   "
233735|NCT00496626|"~     This is a China registration study. A randomized, double-blind, placebo-controlled~     immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male~     participants aged 9 to 15 years. Approximately 600 participants will be randomized in a 1:1~     ratio to receive either vaccine or aluminum-containing placebo. Each participant received one~     injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a~     0.5-mL intramuscular injection. Serum will be collected from all participants to evaluate~     immune response against anti-Human Papillomavirus (HPV) 6/11/16/18 with Luminex Assay. At~     Month 2, Month 6, Month 7, subjects will be evaluated for any new medical condition or health~     concerns and Serious Adverse Experiences throughout the study. The primary objective is to~     evaluate the vaccine-induced serum anti-HPV 6, 11, 16 and 18 antibody titers following 3-dose~     regimen of Gardasil® compared with placebo.~   "
233736|NCT00496613|"~     The purpose of this study is to learn more about how chemotherapy affects an individual's~     thinking abilities (cognition). Some research has shown that chemotherapy can cause changes~     in cognition in breast cancer survivors. However, it is not clear why this change occurs. In~     this study, the investigators will look to see if damage to DNA is related to these changes~     in cognition. Specifically, the investigators want to see 1) if women who have been treated~     with chemotherapy have more DNA damage than healthy women; and 2) if DNA damage is related to~     cognitive problems in breast cancer survivors and healthy women.~   "
233737|NCT00496600|"~     This is an unblinded, dose escalation study of patupilone in combination with RAD001 in~     subjects with advanced cancer to find the maximum tolerated dose of each drug. The purpose of~     this study is to see what doses of RAD001 and patupilone are safe to use when the two drugs~     are used at the same time. Other goals in this study are to learn about the effect of RAD 001~     and patupilone on tumor growth; to find out what amount of RAD001 is present in the blood~     when it is combined with patupilone; to learn about proteins in the blood that may predict or~     show an effect of RAD001 or patupilone and to learn if any changes are seen in the tumor with~     the type of test called a PET scan.Subjects will be assigned to a dosing group. The dose of~     patupilone and RAD001 a subject gets depends on when they enter onto this study. The initial~     subjects in the study will take the lowest doses of RAD001 and patupilone. At least 3~     subjects will be treated in each dosing group starting with the smallest dose. If there are~     few or easy to handle side effects, the next group of at least 3 people to enter in the study~     will get the next higher dose. This continues until the highest dose of the study drug is~     found that does not cause serious or hard to treat side effects. Both the subjects and the~     study doctor will know which dose is assigned. In this study, RAD001 will be given as tablets~     to take with water. RAD001 will be taken for either 7, 14, or 21 days of each 21 day cycle~     depending on which dosing group is assigned. If taking RAD 001 and patupilone on the same~     day, then RAD 001 will be taken with water however prior to receiving patupilone.Patupilone~     will be given by an intravenous injection (through a vein) for 20 minutes on Days 1 or day 6~     of the 21-day cycle. The patupilone dose will be based on height and weight. Blood tests~     (approximately 1-3 teaspoons) will be done every week. Every six weeks a CT scan or MRI will~     be done to assess the tumor size. Subjects will continue to receive RAD001 and patupilone as~     long as the tumor is stable or shrinking, and not having too many side effects from~     treatment.~   "
233738|NCT00496587|"~     The goal of this clinical research study is to learn if the combination of 3 drugs~     (gemcitabine, capecitabine, and bevacizumab) can help to control metastatic or unresectable~     renal cell carcinoma. The safety of this drug combination will also be tested.~   "
233739|NCT00496574|"~     The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on~     clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life,~     lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy~     after three years of SIT in children with asthma.~   "
233740|NCT00496561|"~     The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on~     clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life,~     lung function, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial~     hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in~     children with asthma.~   "
233741|NCT00496548|"~     The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's~     disease activity and to compare how well urinary PGE-M correlates with other non-invasive~     biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.~   "
233742|NCT00496535|"~     The primary objective of the first phase is to determine the safety, the maximum tolerated~     dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied~     combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in~     patients with recurrent head and neck cancer (RHNC). All chemoradiotherapy is administered on~     a week-on/week-off schedule. The primary objective of the second phase II is to determine~     the locoregional control rate at 24 months.~   "
233743|NCT00496522|"~     The goal of this clinical research study is to learn if proton beam therapy, with or without~     photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma.~     The safety of this treatment will also be studied.~   "
233744|NCT00496509|"~     A Phase I, Open-Label Study To Assess The Effect of ZD6474 (ZACTIMA) On Vascular Permeability~     In Patients with Advanced Colorectal Cancer and Liver Metastases.~   "
233745|NCT00496483|"~     A three sequence, open-label, multi-center, prospective, study in stable kidney transplant~     patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of~     LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.~   "
233746|NCT00496470|"~     The purpose of this study is to investigate the effect of combined treatment with Symbicort~     and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in~     patients with severe COPD.~   "
233747|NCT00496457|"~     The purpose of this study is to assess the efficacy and safety of TRO19622 administered PO~     daily for 6 weeks compared to placebo administered PO daily in patients with painful~     peripheral diabetic neuropathy.~   "
233748|NCT00496444|"~     Primary Objective:~      1. To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in~     patients with advanced cancer.~      Secondary Objectives:~        1. To perform a preliminary assessment of the histone acetylation and DNA methylation~          effects of this combination on peripheral blood mononuclear cells (PBMC).~        2. To assess the clinical anti-tumor activity (objective response including complete and~          partial responses) of this combination in patients with advanced cancer, in a~          descriptive fashion.~   "
233749|NCT00496431|"~     This is a multi-center, open label, phase II study testing ITF2357 in a population of very~     high-risk relapsed/refractory Hodgkin's lymphoma patients.~      The patients will receive 50 mg ITF2357 four times a day at 6-hour intervals in fed~     conditions for 28 consecutive days unless evidence of progressive disease, presence of~     unacceptable adverse events or patient's request to discontinue treatment occurs.~      Decision regarding the continuation of ITF2357 will be made on:~        -  the basis of tumor reassessment upon completion of cycle defined as above and not later~          than 7 days and~        -  the occurred toxicity (if any). If complete response or partial response or~          stabilization of disease after first cycle, without concomitant relevant toxicities is~          observed, the treatment may continue as long as there is no evidence of progressive~          disease or appearance of unacceptable adverse events. In any case the treatment shall~          not exceed 84 days of drug intake overall (i.e. 12 weeks).~      Treatment will be administered on an outpatient basis and patients will be followed regularly~     with physical and laboratory tests, as specified in the protocol; in case of hospitalization,~     the treatment will be continued or interrupted according to the Investigators' decision.~      The study will accrue 23 patients evaluable for efficacy and the anticipated duration of the~     study is about 18 months.~   "
233750|NCT00496418|"~     The study aims to prove differences or equalities in outcome for patients operated with or~     without a peristomal mesh in the sublay position when establishing a permanent colostomy.~   "
233765|NCT00496223|"~     This is a combination Phase I/II design that explores the toxicity and activity of Sunitinib~     and Dacarbazine (DTIC) for metastatic melanoma. The initial Phase I part of this trial will~     consist of a dose escalation of sunitinib while keeping the DTIC dose constant. If no DLT is~     seen, this dose will be the suggested Phase II trial dose. If less than 2 disease responses~     are seen, patients will not be enrolled any further, and the study will be considered~     negative for activity. If a clinical response is seen, patients will continue to be enrolled.~   "
233751|NCT00496405|"~     The endothelial growth factor (VEGF), has been implied in the genesis of diverse Neovascular~     disease. In the industrialized and developing countries, the main cause of blindness is the~     diabetic retinopathy. Bevacizumab (Avastin, genentech, Inc., San Francisco, California, the~     USA) is a drug.In the last years its use off-label, in ophthalmology field, has become~     popular. This is due to its proven safeness and effectiveness for the treatment of diverse~     ocular diseases. A lot has been speculated about the systemic absorption of Bevacizumab. It~     is for that reason that the objective of this study is the systematic and random revision of~     the fellows eyes, of the patients programmed for the intravitreal administration of~     Bevacizumab, with bilateral macular edema. In such a way that the therapeutic value in the~     fellow eye of bevacizumab can be determined~   "
233752|NCT00496392|"~     Primary:~      • To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®)~     (hereafter Actiq) in the management of breakthrough pain in cancer patients.~      Secondary:~        -  To compare patients' general impression and preference of NF and Actiq~        -  To explore the relationship between NF doses and dose of current opioid for breakthrough~          pain (BTP) and the relationship between dose of NF and of background opioid~        -  To assess safety and tolerability of NF~   "
233753|NCT00496379|"~     The purpose of this research study is to determine the effects (good and bad) of~     ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that~     is thought to work by interfering with the ability of cancer cells to grow and divide. It is~     a part of a group of drugs called epothilones which appear to cause shrinkage of cancer in~     some patients with breast cancer. It is generally difficult for chemotherapy to enter the~     brain. However, it is believed that ZK219477 crosses into the brain. We are also studying~     whether an investigational MRI scan procedure may eventually help to predict which patients~     will benefit from ZK219477.~   "
233754|NCT00496366|"~     Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that~     is HER2/neu-positive will take part in this study. This type of breast cancer has a high~     amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer~     and normal cells. This family of receptors is important for cell growth and is found in many~     tumor types. The purpose of this research study is to compare an approved treatment for~     breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an~     experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic~     breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used~     to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering~     with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered~     investigational, which means the drug has not been approved by the US Food and Drug~     Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may~     slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However,~     this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine~     may help stop cancer cells as well as or better than capecitabine alone. Other studies have~     demonstrated activity and tolerability of lapatinib either alone or in combination with~     capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and~     lapatinib. A treatment period will be 21 days long. This period is known as a cycle. All~     medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day~     1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken~     daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take~     lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue~     to receive these medications unless they experience severe, serious and/or excessive side~     effects, the cancer becomes worse, the subjects wishes to no longer participate or the study~     doctor feels it is not in the best interest to continue treatment.Tests and procedures such~     as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at~     one or more of the following time points: before the study starts, before each cycle, every 6~     and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.~   "
233755|NCT00496353|"~     The purposes of this phase I portion are; 1) to evaluate the safety and tolerability of~     MK2461 and 2) to determine the recommended phase 2 dose or doses of MK2461.~      The purpose of the phase II portion is to evaluate the anti-tumor efficacy of MK2461.~   "
233756|NCT00496340|"~     The objective of this trial is to determine whether a regimen of pentostatin and busulfan~     (IV) can facilitate engraftment of human leukocyte antigen (HLA) partially compatible~     siblings and unrelated donor transplants by using CD4+ laboratory-guided immunosuppression~     among 41 transplant patients meeting the inclusion criteria.~   "
233757|NCT00496327|"~     To observe the safety and tolerability of the administration of VARIVAX in varicella history~     negative Indian children 12 months to 12 years of age.~   "
233758|NCT00496314|"~     A study which assesses the physician's comfort level and satisfaction when using the e2TM~     Collector compared to the Spatula/SytoBrush technique.~   "
233759|NCT00496301|"~     Main Objective:~      To evaluate progression-free survival in patients with unresectable renal cell carcinoma~     (RCC) treated with a combination of gemcitabine, capecitabine, and sorafenib.~   "
233760|NCT00496288|"~     Women with BRCA germline mutations face a very high risk of developing breast cancer during~     their lives. It was shown that for carrier patients, breast conservation, comprising of~     lumpectomy followed by whole breast radiation, was not associated with increased risk of~     ipsilateral breast cancer recurrence as compared with non carriers (10-15% over 10 years),~     especially if they also underwent prophylactic oophorectomy. Yet their risk of subsequent~     contralateral breast cancer was significantly increased, reported as high as 25-30% over 10~     years and 40% over 15 years, as compared to 3% and 7% respectively in non carriers. The~     reduction in ipsilateral disease was attributed to radiation of the affected breast. We~     propose that for breast cancer patients with BRCA germline mutation that choose to have~     breast-conserving therapy and refuse prophylactic contralateral mastectomy, prophylactic~     radiation to the contralateral breast may reduce the rate of subsequent contralateral breast~     cancer and offer an option for risk reduction.~   "
233761|NCT00496275|"~     To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or~     Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced~     or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.~   "
233762|NCT00496262|"~     This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and~     clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen~     deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen~     when a fixed dose of human fibrinogen concentrate was administered.~   "
233763|NCT00496249|"~     Many younger men are diagnosed with prostate cancer. These patients are often choosing~     radiation therapy as their primary treatment. The effect of this therapy on fertility will~     have a direct impact on their decision about therapeutic options and fertility preservation.~     The researchers hypothesize that when patients are treated with radiation for localized~     prostate cancer, infertility can occur due to direct damage to seminiferous tubules affecting~     sperm quality.~   "
233783|NCT00495989|"~     This is an evaluation of potential differences in saliva composition and dental calculus~     composition between orally fed and tube fed individuals in an institutional environment.~   "
233766|NCT00496210|"~     This study will explore predictors of how caregivers might adapt to children diagnosed with a~     pervasive developmental disorder (PDD), including autism, Asperger s syndrome, childhood~     disintegrative disorder, Rett s disorder or other not specified PDD. PDD presents particular~     challenges for caregivers because of the communication and socialization challenges of~     affected children and because of the uncertainty surrounding the cause, prognosis and~     recurrence risks.~      People 18 years of age or older who are the primary caregiver for a child diagnosed with a~     PDD may be eligible for this study. Participants fill out a survey, either online or in hard~     copy, that includes information in the following categories:~        -  How being a caregiver for a child with a PDD has impacted the caregiver.~        -  How much control the caregiver feels that he or she or others have over certain aspects~          of their child s PDD.~        -  What the caregiver thinks caused the child s PDD.~        -  What coping techniques the caregiver uses in caring for a child with a PDD.~        -  How uncertain the caregiver feels about his or her child s PDD.~        -  What the caregiver feels about him- or herself as a caregiver of a child with a PDD.~        -  General questions about the caregiver, his or her family and the child with a PDD.~   "
233767|NCT00496197|"~     The purpose of this study is to further evaluate the safety and effectiveness of intravenous~     anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis,~     which is a fungus infection of the blood or tissue. Currently the drug is approved for~     treatment using a daily dose of IV medication until 14 days after the fungus disappears from~     the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is~     administered for 5-28 days followed by oral antifungal medication. Study patients will be~     assessed for response to treatment throughout the study drug treatment period.~   "
233768|NCT00496184|"~     To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked~     localized Vulvodynia (vestibulitis, vestibulodynia).~   "
233769|NCT00496171|"~     The purpose of the study is to determine the most effective formulation of HAL for release of~     hexaminolevulinate to the cervical epithelium at different doses.~   "
233770|NCT00496158|"~     The objectives of this study are to compare in nucleoside treatment-naïve subjects, the~     efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as~     monotherapy, for 48 weeks, 72 weeks, and 96 weeks.~   "
233771|NCT00496145|"~     Type II diabetes is a growing health concern for Latinos who not only have a higher incidence~     of the disease but also suffer great morbidity. At the same time due to poverty, language,~     low literacy and lack of continuity of care, this population is largely excluded from current~     diabetes education programs. To assist with this problem we propose to evaluate 1) a~     community-based, peer-led Spanish Diabetes Self-Management Program that is culturally~     appropriate and acceptable based on self-efficacy theory, and 2) the effects of long-term,~     self-tailored educational reinforcement offered by means of automated telephone disease~     management messages. Should this research be successful it will provide an evidenced based~     public health diabetes education model for use with Latino populations throughout the United~     States.~   "
233772|NCT00496132|"~     This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of~     single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed~     after or were refractory to treatment with a purine nucleoside analogue-containing regimen.~     The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II~     expanded treatment cohort, with enrollment of additional patients in order to expand safety~     experience and collect preliminary anti-leukemia activity data.~   "
233773|NCT00496119|"~     The goal of this clinical research study is to learn if proton beam therapy, with or without~     photon beam radiation therapy, is effective in the treatment of skull base chordoma. The~     safety of this treatment will also be studied.~   "
233774|NCT00496106|"~     The purpose of the study is to:~        1. Test the efficacy of psychosocial telephone counseling (PTC) for cervical cancer~          survivors, compared to usual care.~        2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer~          patients who have received PTC, compared to usual care.~        3. Examine the longitudinal relationship between PTC associated modulations of quality of~          life (QOL) measures and biologic parameters (immune and neuroendocrine).~   "
233775|NCT00496093|"~     To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy~     adults in India.~   "
233776|NCT00496080|"~     The objective of this study is to evaluate the safety and effectiveness of Doppler guided~     uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.~   "
233777|NCT00496067|"~     The primary objective of this study is to evaluate the safety and effectiveness of Doppler~     guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated~     symptoms.~   "
233778|NCT00496054|"~     To observe the safety, tolerability and immunogenicity of the administration of 3 doses of~     rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.~   "
233779|NCT00496041|"~     This is a Belgian prospective multicentre registry on the performance of the Smart stent in~     the superficial femoral artery according to the new tasc II-classification.~   "
233780|NCT00496028|"~     This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2~     phases are part of a single study and described by this single protocol. Patients entered~     into the dose escalation phase will not be entered into the expansion phase. All subjects~     must be suitable for treatment with either carboplatin and/or paclitaxel.~   "
233781|NCT00496015|"~     The purpose of this trial is to assess if the rate of febrile reactions following the~     co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant~     vaccines is lowered when paracetamol is given prophylactically and to assess the impact of~     pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage~     compared to control group receiving meningococcal conjugate vaccine (GSK134612).~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00370318).~   "
233782|NCT00496002|"~     The objectives of this study are to compare in nucleoside treatment-naïve subjects, the~     efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as~     monotherapy, for 48 weeks and 96 weeks.~   "
233785|NCT00495963|"~     Background and Objectives: There is a need to validate and suggest easy and less costly~     diagnostic method for diagnosis of ventilator-associated pneumonia in developing country. The~     study was performed to compare available methods for the diagnosis and to characterize the~     organisms causing VAP.~      Design and Methods: All patients on mechanical ventilation for more than 48 hours and~     simplified CPIS ≥ 6 were enrolled prospectively. Four diagnostic procedures, endotracheal~     aspiration (ETA), blind bronchial sampling (BBS), blind bronchoalveolar lavage (blind BAL)~     and bronchoscopic BAL (BAL) were performed in same sequence within 12 hours. The bacterial~     density ≥ 104 cfu/ mL BAL samples were taken as reference standard.~   "
233786|NCT00495950|"~     The goal of this study is to measure the amount of limb swelling (lymphedema) that sometimes~     occurs after melanoma treatment, and to find out how people feel and react to the diagnosis~     and treatment of melanoma.~   "
233787|NCT00495924|"~     The purpose of this study is to determine whether early recurrence after curative resection~     of ductal pancreatic adenocarcinoma can be explained by either dissemination of cancer cells~     during intraoperative tumour manipulation, post-operative systemic immune suppression,~     alteration of biological properties of circulating cancer cells or a combination of these.~   "
233788|NCT00495898|"~     The main objective of this study is to assess the safety and effectiveness of the CYPHER~     sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary~     artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients~     with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent~     Delivery System.~   "
233789|NCT00495885|"~     The purpose of this study is to assess efficacy and safety of volinanserin in the population~     of patients complaining of sleep maintenance insomnia. The objective of the substudy is to~     assess glycemic control in the subgroup of patients with type II diabetes mellitus.~   "
233790|NCT00495872|"~     The goal of this clinical research study is to find the highest tolerable dose of valproic~     acid in combination with either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide,~     sorafenib, or SU011248 (sunitinib malate) that can be given to patients with advanced cancer.~     The safety of each combination of the study drugs will be studied as well.~   "
233791|NCT00495859|"~     Patients with endstage liver disease characteristically are malnourished which is associated~     with poor outcome. Formulas enriched with arginine,ω3 fatty acids, and nucleotides~     potentially improve their nutritional status. This randomized placebo-controlled double blind~     multicenter clinical trial with longterm preoperative supplementation with such an enriched~     formula will evaluate evaluate effects of such formulas on patients' quality of life,~     survival, and posttransplant morbidities.~   "
233792|NCT00495846|"~     The hepatocellular carcinoma (HCC) represents more than 5% of all human malignancies, with~     more than 500,000 deaths per year (1). In Campania region, mortality for HCC is 2 times~     higher than in the rest of Italy because of a higher locally prevalence of hepatitis-C virus~     infection.~      Development of HCC in liver cirrhosis is associated with increased DNA synthesis and~     regeneration of hepatocytes (2). Hepatocyte growth factor, the transforming growth factor-α,~     the fibroblast growth factor are well studied (3,4) while the insulin-like growth factor~     system (IGF-I, IGF-II and their binding proteins) has been less investigated. IGF-I and~     IGF-II modulate growth, metabolism and cell differentiation and have specific receptors in~     the liver (5). IGF-I levels in the upper normal range have been associated with an increased~     risk to develop prostate cancer (6), breast cancer (7) and colon cancer (8). Some data report~     increased expression of IGF-II in HCC (9,10) and others suggest a role of increased IGF-I~     bioavailability in HCC (11). We reported increased IGF-I/IGFBP-3 ratio in patients with HCC~     compared with those with cirrhosis with a similar liver function, so suggesting increased~     IGF-I bioavailability in HCC (12).~      There is no currently medical treatment for patients with advanced HCC which has a very poor~     prognosis (survival <6 months). Because of limited liver function, classical chemotherapy~     cannot be applied (13). In patients with HCC without cirrhosis, surgery is possible only in~     5% while in those with cirrhosis first-line treatment is still questioned as survival is <50%~     three years after operation. Patients suitable for local resection of HCC are only those with~     Child-Pugh's hyper A liver function class, who are a minority (14-16). Percutaneous~     resection treatments may treat approximately 70%-90% of tumors with maximal diameters of <3~     cm (15,17-19).~      Somatostatin analogues are indicated in patients with neuroendocrine tumors expressing~     somatostatin receptors type 2 and 5 and has excellent safety profile. In advanced HCC, some~     studies demonstrated beneficial effects (20,21) while some others did not (22,23).~      Only a few data are available on somatostatin receptor expression in HCC (24,25).~     Somatostatin analogues have also a clear-cut inhibitory effect on circulating IGF-I levels~     with a potential additional effect in delaying HCC progression.~   "
233793|NCT00495833|"~     Overview: This study uses communications strategies delivered through the traditional~     emergency medical response system to increase the proportion of low-income adults who obtain~     blood pressure screening and follow-up information for hypertension treatment options. The~     project will test the effectiveness of source personalization and tailored messaging in~     motivating potentially high-risk people, identified by 911 responders, to come to a local~     fire station for hypertension screening.~      Specific Aims: The specific aims are:~        1. Test the effectiveness of three health marketing approaches to motivate high-risk~          people, identified via 911 responders, to come to a local fire station for hypertension~          screening. The mailed marketing approaches vary personalized risk information and~          personalization of source.~        2. Test the effectiveness of two mailing interventions (blood pressure kits with and~          without promotional gifts) to increase blood pressure monitoring among patients who have~          come to a fire station for a second blood pressure check.~   "
233794|NCT00495820|"~     The purpose of the study is to determine the efficacy of methylphenidate over placebo in~     treating apathy in patients with Alzheimer's dementia. Apathy is one of the earliest and most~     profound disturbances that occur in Alzheimer's dementia (AD).~      Hypotheses: 1. Methylphenidate (MPH) will improve apathy significantly more than placebo in~     AD.~      2. Successful treatment of apathy will improve Instrumental Activities of Daily Living~     (IADLs), and caregiver burden.~   "
233795|NCT00495807|"~     Psychological implications expressed pivotal effects on daily activities. Postoperative pain~     management is always encountered varying influence from the ambience of surgical wards,~     especially the nurses. We hypothesized that nurses' negative or positive words would produce~     unexpected role in pain management, which might be a strong factor resulting in the failure~     of postoperative analgesia.~   "
233806|NCT00495651|"~     The Temprano trial is based on the following assumptions:~        -  ART initiation at CD4 counts <800/mm3 could significantly reduce the probability of~          severe HIV-related morbidity or death in the medium term.~        -  Tuberculosis and tuberculosis-related deaths are likely to represent a considerable~          proportion of morbidity and mortality among HIV-infected patients with high CD4 counts~          in sub-Saharan Africa. Therefore, 6-month Isoniazide Prophylaxis for Tuberculosis (IPT)~          and early ART could enhance each others efficacy.~   "
233796|NCT00495794|"~     Background: Good blood pressure (BP) control among patients with diabetes is essential in~     preventing diabetes complications and has been found to be not only cost-effective but~     cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP~     control. Among these poorly controlled patients, over 65% have problems with medication~     adherence or inadequate intensification of medications. We therefore propose a partnership~     with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored~     clinical pharmacist-based intervention to improve medication management, adherence and BP~     control.~      Objectives: The specific objectives of this implementation study are: 1) To evaluate the~     effects of the intervention on blood pressure (primary outcome) and glycemic and lipid~     control (secondary outcomes); 2) To assess the impact of the intervention on patients'~     adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity~     of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to~     usual care; 4) To evaluate the level of attainment of intervention implementation, examine~     the process of intervention implementation, and determine the potential for sustainability.~   "
233797|NCT00495781|"~     The purpose of the study is to define laboratory parameters which are best suited to diagnose~     functional iron deficiency. Functional iron deficiency is a condition where - due to the lack~     of iron bioavailability - the patient suffers from symptoms such as fatigue and weakness, or~     his/her capacity to produce red blood cells is reduced.~   "
233798|NCT00495768|"~     The purpose of this study is to conduct a randomized controlled trial of an 8-visit~     non-pharmacologic group intervention in reducing the severity of depressive symptoms in~     veterans who receive IFN and ribavirin for the treatment of Hepatitis C. We hypothesize that~     over the first 6 months of treatment with IFN and ribavirin for the 45 patients who receive~     the 8-visit intervention early in the course of treatment in addition to usual care~     (experimental group) will have lower scores on the CES-D, a standard depression rating scale,~     than the 45 patients who receive only usual care (control group).~   "
233799|NCT00495755|"~     The CD52 antigen, which is targeted by alemtuzumab, is highly expressed on mature T~     lymphocytes, monocytes and monocyte-derived dendritic cells as well as on mature B cells. Due~     to its more promiscuous effect on immune cells, alemtuzumab not only targets antibody~     producing B lymphocytes as does rituximab, but also targets alloreactive T lymphocytes and~     dendritic cells that also contribute to the complex pathogenesis of chronic GVHD.~      Our hypothesis is that alemtuzumab will be effective in the treatment of chronic GVHD through~     its promiscuous depletion of alloreactive T lymphocytes, dendritic cells as well as antibody~     producing mature B-lymphocytes.~   "
233800|NCT00495729|"~     Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7~     days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and~     cognition function tests.~   "
233801|NCT00495716|"~     The purpose of this study is to determine what effect suppressive therapy has on sexual~     behavior and quality of life among persons with genital herpes (HSV) who have multiple sex~     partners.~   "
233802|NCT00495703|"~     Cognitive dysfunction following chemotherapy is an adverse treatment effect that impacts the~     quality of life for many cancer survivors receiving this adjuvant therapy. A strong body of~     evidence now indicates that that the initiation of a regular exercise program, at levels that~     are readily achievable by most adults (3-5 d/wk, 30-45 min/session), can improve cognitive~     function. Importantly, the domains of cognitive function that are enhanced by exercise~     participation are the same domains that are negatively affected by chemotherapy. Accordingly,~     we propose a 2 year research program that seeks to develop and test a safe, simple, and~     effective exercise intervention to optimize cognitive function following chemotherapy. To~     begin this research, we will: 1) conduct a randomized exercise intervention trial among~     cancer survivors that report persistent cognitive problems following chemotherapy (n=60), 2)~     explore possible mediators and moderators of the intervention on cognition in order to begin~     to understand how the intervention may work and for whom it may be most effective, and 3),~     conduct a cross-sectional study comparing cancer survivors enrolled in the trial (n=60) and~     matched controls (n=40) to evaluate the cognitive status among survivors in the intervention.~     We hypothesize that six-months of regular exercise will enhance cognitive function among~     cancer survivors, and that cancer survivors reporting cognitive dysfunction will have lower~     objectively measured cognitive performance than adults who have not received chemotherapy. To~     our knowledge this study would be the first to examine the influence of regular exercise~     participation on cognitive function among cancer survivors that experienced cognitive~     difficulties following chemotherapy.~   "
233803|NCT00495690|"~     Title: Impact of daily zinc supplementation to infants born with low birth weight on~     mortality and severe disease requiring hospitalization Background: Zinc supplementation was~     shown to prevent diarrhea and pneumonia in 6 month to 3 year old children. Little is known~     about the impact of zinc supplementation of low birth weight (LBW) babies during first 6~     months of life.~      Objective: The objectives were to determine the impact of daily zinc administration at 1RDA~     (5 mg) of elemental zinc to LBW infants on severe morbidity requiring hospitalization and on~     all cause mortality.~      Design: In a double blind randomized placebo controlled trial 2012 hospital-born infants with~     a birth weight <2500 g were randomly assigned to receive zinc or placebo for 6 months. Zinc~     group received 5 mg elemental zinc as acetate daily from 4 weeks age. Cause specific~     hospitalization deaths, episodes of diarrhea, acute respiratory infections, other illness,~     visits to health care providers and hospital OPDs were ascertained by in-depth interview and~     from documents like prescriptions, hospital tickets, medicine cartons at 3 and 6 months of~     age.~      Results: Number of infants with one or more diarrhea episodes was less by 17% (95% CI: 1% to~     35%) in the zinc group but the numbers for ARI were similar in the two groups. The~     hospitalization rates due to all causes or diarrhea or ARI were similar in the two groups.~     Twelve in the zinc group and 9 in the placebo group died during 4 weeks to 6 months (p=0.36).~     We observed no significant difference for gain in weight and length at 3 months and 6 months~     between the groups. In a subgroup of infants the mean serum zinc concentration in the zinc~     group was 27% higher (p=0.004) than the placebo group.~      Conclusion: Hospital born, low birth weight infants do not seem to derive worthwhile benefit~     from daily zinc supplementation of recommended dietary allowance for zinc in terms of~     morbidity and growth during first six months of life.~   "
233804|NCT00495677|"~     To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral~     doses of PF 00232798 in HIV-positive patient volunteers.~   "
233805|NCT00495664|"~     Coronary-stent implantation is commonly performed for treatment of acute myocardial~     infarction (MI). Drug eluting stents (DES) among selected patients have been shown to reduce~     target lesion revascularization (TLR) after percutaneous coronary intervention (PCI).~     However, there is no studies comparing titanium-nitride-oxide (TITANOX) coated stent with~     paclitaxel-eluting stent (PES) in acute MI.~   "
233831|NCT00495313|"~     To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole~     gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%~   "
233807|NCT00495638|"~     The study will look at the risk factors for pulmonary hypertension (high blood pressure in~     the lungs) in children and adolescents with sickle cell anemia (SCA) and examine the role of~     hypoxia (oxygen shortage) in the disease. In patients with SCA, red blood cells become~     sickle-shaped and tend to form clumps that get stuck in blood vessels, blocking blood flow to~     the limbs and organs. Blocked blood vessels can cause pain, serious infections, and organ~     damage. Many patients with SCA also develop pulmonary hypertension.~      Children and adolescents with SCA or Chuvash polycythemia (another blood disorder that~     carries an increased risk for pulmonary hypertension) may be eligible for this study.~      Participants undergo the following procedures at the beginning (baseline) and end of the~     study:~        -  History, physical examination and blood tests .~        -  Echocardiography (ultrasound study of heart function).~        -  Transcranial doppler (brain ultrasound study to measure brain blood flow).~        -  Lung function tests.~        -  6-minute walk (measure of the distance covered in 6 minutes of walking).~      In addition, patients are followed by telephone or by clinic visits every 6 months for a~     review of their medical history and medications. A physical examination is also done at 12~     months.~   "
233808|NCT00495625|"~     An open label multi-site phase II clinical trial of dose escalated sunitinib malate given~     orally once daily on days 1-28 of each 42-day cycle. Treatment will be continued until there~     is either disease progression or cumulative or acute toxicity which in the opinion of the~     treating physician compromises the ability of the patient to receive treatment or patient~     desire to stop treatment.~   "
233809|NCT00495612|"~     This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with~     a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with~     placebo, reduces the degree of bronchoconstriction induced by environmental cat dander~     exposure in patients 18-65 years old with stable, moderate asthma and a history of cat~     dander-induced asthma symptoms.~   "
233810|NCT00495599|"~     The central hypothesis of our study is that metabolic and hemodynamic improvements following~     gastric bypass surgery are mediated by downregulation of inflammation-related adipokines~     produced by the intra-abdominal adipose tissue such as Visfatin.~   "
233811|NCT00495586|"~     The purpose of this study is to determine the effectiveness of antibiotic therapy for~     patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.~   "
233812|NCT00495573|"~     The purpose of the study is to evaluate the pattern of viral shedding after beginning~     treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with~     the pattern of viral shedding during an untreated clinical recurrence of genital herpes.~   "
233813|NCT00495560|"~     Induction termination of pregnancy (second trimester abortion) has a median time of 14 hours~     from the start of medication (misoprostol) to expulsion of the fetus. The objective of this~     study is to evaluate a method of 'priming' on the length of induction termination of~     pregnancy. Priming refers to the use of medication to ready the cervix and uterus so that~     the uterus is more sensitive to medication and contracts more effectively, and also refers to~     softening of the cervix so that there is less resistance to dilation. Priming is used~     extensively before induction of labor for term pregnancy and is also used extensively before~     surgical abortion in second trimester. We would like to add priming the evening before~     induction to the usual treatment and evaluate whether the length of the induction process is~     shortened. Women are admitted to the hospital in the morning to start misoprostol medication,~     and unless expulsion occurs within 8-10 hours, need to stay overnight.~      The study design is to give the priming dose 12 hours before admission. The outcome of~     interest is the induction time from the first dose on misoprostol in the hospital to~     expulsion of the fetus.~      This study aims to assess whether the use of misoprostol as a priming agent would be~     beneficial with women who undergo induction termination of pregnancy.~   "
233814|NCT00495547|"~     The primary objective is to evaluate the efficacy of the treatment in response rate terms.~     Otherwise this study wants to evaluate the safety of the treatment.~   "
233815|NCT00495521|"~     The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release~     oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times~     daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will~     resolve an acute flare of ileocecal Crohn's disease.~   "
233816|NCT00495508|"~     A) for the treatment of uncomplicated malaria during second and third trimester pregnancy to~     oral Quinine hydrochloride. The PCR-corrected adequate clinical and parasitological response~     (ACPR) on day 42 is considered as the primary efficacy criterion. Newborns will be followed~     for growth and development indicators.~   "
233817|NCT00495495|"~     Caries means demineralization with the formation of cavities and pulp symptoms and necrosis~     as an end result. The acids in the mouth are mainly produced by oral bacteria like~     Streptococcus mutans from bacterial biofilms adhering to the tooth. Ozone has been shown to~     have a very strong bactericidal effect on bacteria causing dental caries. Baysan et al~     reported that there was a statistically significant reduction of streptococci in root caries~     lesions and saliva samples after ozone application. The positive clinical effect of ozone~     with respect to arresting caries progression and the remineralization of caries has been~     shown in vitro and in vivo. In an in vivo study, Baysan and Lynch found that the application~     of ozone resulted in a significant reduction of bacterial contamination as well as a~     reduction in size and severity of root caries lesions. In a subsequent study, Baysan and~     Lynch reported that the severity of root caries lesions was significantly reduced after ozone~     application as measured by electrical conductance and laser fluorescence. In several studies,~     the caries reducing effect of ozone was measured with biochemical methods in root surface~     caries lesions, the biofilm and saliva after ozone application. See Citation section for~     references.~      The objectives of this multi-center clinical study were to determine: (1) the effectiveness~     of the HealOzone in stopping the progression of fissure caries; and (2) the oral soft tissue~     safety of the ozone system.~   "
233818|NCT00495482|"~     Euthanasia and assisted dying are of growing interest for patients with incurable diseases.~     The possible methods are widely discussed by patient-societies, physicians, lawyers,~     theologians and philosophers. During the last years several opinion-polls were conducted with~     healthy people or medical stuff, but no surveys were conducted to get the attitude of~     incurable ill patients.~      The hypothesis of the investigators' study is: Palliative Care Medicine is a better option~     for incurable ill patients than an assisted suicide.~   "
233819|NCT00495469|"~     This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of~     doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in~     treatment-naive subjects with type 2 diabetes mellitus~   "
233820|NCT00495456|"~     The burden of cardiovascular disease (CVD) is considerable, despite many advances in~     diagnosis, clinical management and drug therapy. The World Health Organization estimates 30%~     of global deaths are attributable to CVD and whilst mortality rates in developed countries~     are falling, it remains the largest single cause of death (WHO, 2007). Nineteen out of every~     100 deaths in Australia are attributed to CVD, with an annual cost of $1.47 billion (AIHW,~     2006).~      Assessing the risk of future cardiovascular events is traditionally based on a number of~     'risk-factors' determined by observational clinical studies such as the Framingham cohort.~     Recent evidence however invalidates their use in both the highest and lowest risk groups and~     raises questions about applying such methods in changing risk-behaviour. A considerable~     number of new risk markers have surfaced in recent years (including various biomarkers, pulse~     wave velocity and measures of arterial function). Unfortunately their long-term predictive~     capacity is largely unknown, particularly when compared with existing risk factors.~      The aims of this study are to provide objective longitudinal data for a wide variety of risk~     markers both in current use and in development. Participants of current on-going clinical~     studies at will be approached to lengthen their observation period for the purposes of~     determining long-term clinical outcomes.~      Standard clinical observations and data obtained within the participant's enrolled studies~     will be collated into an electronic database. All existing and future studies must have~     individual approval from an appropriate ethics committee with signed consent. The baseline~     studies and follow-up assessments of this cohort will be correlated with cardiovascular~     events, hospitalizations and mortality. In addition, volunteers can be directed to~     appropriate clinical studies in CVD, thereby enhancing recruitment, encouraging good quality~     clinical studies and advancing knowledge of cardiovascular disease prevention.~   "
233821|NCT00495443|"~     The purpose of this study is to determine whether a new laser system provides better safety~     and efficacy than existing lasers in popular cosmetic procedures such as hair removal,~     treatment of cosmetically disturbing vascular lesions and rhytides.~   "
233822|NCT00495430|"~     The primary purpose is to test intersubject variability and establish the qualitative~     features of normal VRI images and the range of normality of the VRI quantitative lung data~     values that may be used to differentiate normal from abnormal breath sound distribution. Our~     hypothesis was that VRI breath sound images of healthy subjects are similar in a qualitative~     and quantitative manner.~   "
233823|NCT00495417|"~     The purpose of this study is to assess the tolerability and safety of repeated subcutaneous~     injection of a single dose of Affitope AD01 in patients with mild to moderate Alzheimer's~     Disease.~   "
233824|NCT00495404|"~     Although the use of opioid medications has gained increasing acceptance as a treatment option~     for chronic pain, there is little empirical research concerning long-term outcomes with this~     patient population. Several important questions concerning the use of opioids have yet to be~     examined in controlled studies. These include: determination of the most effective dosing~     regime, specification of the risk factors for medication abuse, and identification of~     patients most likely to achieve long-term benefits. Despite the lack of empirical data, the~     clinical literature to date yields two general approaches to the use of opioid treatment with~     chronic, nonmalignant pain. The first approach dictates that due to risk of addiction,~     tolerance, and insensitivity to large doses, opioid medications should be carefully~     controlled, with minimal and stable dosing as the eventual goal of treatment. The second~     approach, fostered by the beneficial use of opioids in the treatment of cancer pain,~     maintains that risk of addiction and abuse has been exaggerated. Proponents of this approach~     suggest that under-medication is a significant cause of treatment failure and non-compliance~     in chronic pain patients, and that prescription guidelines should emphasize patients� reports~     of adequate relief, regardless of dosage.~   "
233825|NCT00495391|"~     The purpose of this study is to determine if nitazoxanide in combination with peginterferon~     alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in patients that~     have previously failed to respond to treatment with peginterferon and ribavirin.~   "
233826|NCT00495378|"~     The purpose of this study was to determine if alternate dosing of Epoetin alfa was effective~     in maintaining hemoglobin levels in patients with chemotherapy related anemia.~   "
233827|NCT00495365|"~     The purpose of this study was to evaluate hemoglobin stability in subjects who had received~     darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to~     epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus~     1 g/dL (range 11-13- g/dL).~   "
233828|NCT00495352|"~     Cigarette smoking represents a major health problem for patients suffering from~     schizophrenia. Compared to the general population, schizophrenic patients are significantly~     more likely to be addicted to nicotine. They also are more likely to be heavy smokers, and~     tend to be exposed disproportionately to nicotine and other harmful ingredients in the~     cigarette because of the observed tendency to smoke down to the very end. Further, smoking in~     these patients may be associated with a higher risk for developing tardive dyskinesia All of~     these factors render schizophrenic patients a particularly vulnerable group for the~     detrimental effects of tobacco-related medical problems. Currently, there is little~     information available regarding the efficacy and utility of smoking cessation treatment~     methods, as well as factors that may predict patients' response to such treatments.~      An important related issue is the influence of smoking, and its cessation, on the effects of~     the medications most of these patients rely upon for the control of their psychiatric~     symptoms. Although smoking has long been known to significantly alter the metabolism, and~     thus the effects, of most antipsychotics, the extent and clinical significance of these~     influences have rarely been assessed. It is unclear to what extent smoke cessation (as well~     as initiation) changes the side effect profiles of these medications, and whether such~     changes contribute towards the difficulties in patients' ability and/or willingness to stop~     smoking.~      In addition, except pharmacological intervention, readiness to change may be an important~     factor affecting the outcomes of smoking reduction. Prochaska et al proposed the concept of~     stages of change to predict the response of quitting behavior for substance use. A lot of~     evidence support the stronger of readiness of change, the higher successful rate of quitting~     can be reached. Yet these results are largely found in many non-pharmacological intervention~     and smoking cessation programs for general population. Till now, no available study solely~     focus readiness of change quitting smoking behavior in NRT treatment for chronic~     schizophrenic patients. Thus, we have an a great interest in examining the association~     between the stages of change and the outcomes of smoking-cessation along with reduction among~     schizophrenic patients receiving transdermal nicotine patches.~      In order to begin addressing these important issues, this application proposes to utilize~     state-of-the-art methodologies derived from the field of pharmacogenetics, molecular biology~     and clinical trials, to (1) examine short-term and long-term efficacy of standard treatment~     methods, such as the use of nicotine patches, in this population; (2) identify factors that~     might predict treatment responses; and, (3) examine the interactions between smoking and the~     effect of antipsychotics, as well as how such interactions might affect smoking cessation.~     (4) to examine the predictive value of the stages of change on smoking cessation and~     reduction outcomes in schizophrenic patients receiving different doses of nicotine~     replacement therapy (NRT) and bupropion as implemented in a randomized trial.~   "
233829|NCT00495339|"~     Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine~     therapy of MDR TB.~      Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.~   "
233830|NCT00495326|"~     The purpose of this study is to determine whether the use of Nevirapine in HIV patients~     already treated against tuberculosis by Rifampicin is as efficient and as well tolerated as~     Efavirenz.~   "
233832|NCT00495300|"~     This protocol will collect blood samples and medical information from patients who have had a~     bone marrow transplant using cells from an unrelated donor identified through the National~     Marrow Donor Program (NMDP). The NMDP has two programs in which patients can participate: the~     Research Database Program and the Research Sample Repository.~      Patients who have received a bone marrow transplant at the NIH or other institution from an~     unrelated donor affiliated with the NMDP may be eligible for this study.~      Participants in the NMDP Research Database program will have medical information about their~     disease and their transplant sent to the NMDP before and after the transplant and once a year~     for the rest of their life. The information will be used to help determine how well~     transplant recipients recover from their transplant, how recovery after a transplant can be~     improved, how access to transplant for different groups of patients can be improved and how~     well donors recover from collection procedures.~      Participants in the NMDP Research Sample Repository program will have a small blood sample~     drawn from a vein in the arm just before they start taking medicines for the conditioning~     regimen to prepare them for the transplant. The blood samples will be used to look at ways to~     improve how patients are matched with their donors, to determine and evaluate the factors~     that affect transplant outcome, and to help develop methods to improve tissue matching~     between donors and recipients....~   "
233833|NCT00495287|"~     The study was set up to assess:~        1. Standard-dose versus high-dose remission induction therapy. A standard ICE chemotherapy~          vs sequential high-dose cytarabine, with appropriate supportive/prophylactic measures,~          followed by morphological, cytogenetic and molecular monitoring of remission.~        2. A risk-oriented postremission therapy: HR patients will be electively submitted to~          allogeneic stem cell transplantation (allo-SCT), whenever possible (related/unrelated~          donor/cord blood; ablative/non-ablative conditioning according to national and local~          protocols and guidelines). Provided sufficient blood stem cells were previously~          collected (>2x10e6/kg Cluster of Differentiation 34 cells), SR patients and HR patients~          excluded from allo-SCT and aged 65 years or less will be randomized to: myeloablative~          autologous blood stem cell transplantation vs non-myeloablative, multicycle, autologous~          blood stem cell-supported high-dose cytarabine-based therapy.~             -  HR/SR patients unable to be randomized because of inadequate blood stem cell yield~               will receive intermediate-dose consolidation; patients aged >65 years will be~               treated with age-adapted therapy.~   "
233834|NCT00495274|"~     The purpose of this study is to select the formulation with the optimal pharmacokinetic~     profile for an hypnotic drug to further develop in the market.~   "
233835|NCT00495261|"~     In recent years, mindfulness meditation has been shown to be a promising approach for~     alleviating emotional distress associated with chronic medical and psychiatric conditions and~     in reducing relapse following treatment for depression. The applicability of mindfulness~     meditation to problem gambling has not yet been explored. Mindfulness meditation may be~     particularly suitable for this clinical disorder as it stresses a process-oriented,~     metacognitive, approach to cognitive pathology in contrast to a content-focused approach,~     characteristic of traditional approaches to treating cognitive psychopathology.~     Gambling-related cognitive psychopathology is a well-known characteristic of problem gambling~     and frequently the target of therapy. Although there is growing evidence that~     cognitive-behavioral treatments are effective for gambling, outcomes may be improved by~     teaching gamblers additional ways to cope with cognitive distortions that emphasize~     metacognitive processes.~   "
233836|NCT00495248|"~     The aim of the study is to evaluate the effect of a group intervention programme for~     community dwelling elders with stroke or TIA.The intervention is inspired by a Lifestyle~     Redesign method developed in the USA. The study is conducted as a multi centre randomized~     controlled trial. Participants are recruited from five hospitals and the intervention is~     implemented at six to seven senior centres. The control group is offered physical activity at~     the senior centre once a week. The intervention group is offered the same with addition of~     the programme inspired by Lifestyle Redesign. The study will contribute to knowledge whether~     the intervention will promote social participation and thriving in daily life and prevent~     social isolation and depressive symptoms among community dwelling elders with stroke or TIA.~   "
233837|NCT00495235|"~     The goal of this clinical research study is to find out if there is a link between insulin~     resistance (or pre-diabetes) and endometrial cancer.~      Primary Objective:~      1. To determine the association between insulin resistance and endometrial cancer in women in~     Harris County, Texas. 2. To assess the effect of body mass index (BMI) on the association~     between insulin resistance and endometrial cancer.~      Secondary Objectives:~        1. To explore the association between polycystic ovarian syndrome (PCOS) and endometrial~          cancer.~        2. To assess the relationship between known reproductive risk factors, menstrual risk~          factors, family history and endometrial cancer.~        3. To explore the molecular changes associated with insulin resistance and PCOS on normal~          endometrium and tumor tissue.~   "
233838|NCT00495222|"~     The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic~     Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ~     anastomosis in subjects who are regaining weight after successful weight loss following~     gastric bypass. Post-procedure weight will be followed to assess whether weight loss is~     resumed.~      The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated~     for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to~     facilitate endoscopic gastrointestinal procedures.~   "
233851|NCT00495053|"~     The purpose of this study is to evaluate the safety of a new product that uses human gene~     transfer (called hMaxi-K) when it is given to patients with overactive bladder. Human gene~     transfer is a new type of therapy that is the process of placing genetic material (DNA or~     RNA) into a person. The primary objective of this study is to evaluate safety parameters~     occurring subsequent to administration of a single intravesical instillation of study drug.~      Three different dose groups of hMaxi-K will be tested in this study consisting of 5000,~     10,000 and 15,000 micrograms. hMaxi-K will be given as a single administration into the~     bladder through a catheter. Each women's participation in the study will last for up to 24~     weeks (followed by an additional 18 month follow-up period).~   "
234031|NCT00492661|"~     The purpose of this trial is to investigate whether a combined dietary and exercise~     intervention, added to standard care, reduces the expected frequency of insulin resistance in~     renal (kidney) transplant recipients on tacrolimus.~   "
233839|NCT00495209|"~     The use of complementary and alternative medicine (CAM) in the United States has increased~     dramatically in the past 10 years. Nowhere is this trend more apparent than when one examines~     CAM use by patients diagnosed with cancer. As with the general population, patients with~     cancer typically use CAM-based modalities alongside their conventional cancer treatments.~     Patients are often seeking a holistic approach to managing and preventing disease. Although~     most patients will combine alternative approaches with conventional medicine, some patients~     do in fact decline curative conventional treatments in favor of more non-toxic alternative~     approaches. One such approach that patients combine with conventional medicine or use in~     place of conventional medicine is qigong.~      Qigong is a bioenergy therapy with a long history of therapeutic use for many diseases,~     including cancer. Preliminary experiments and a review of the literature show that qigong~     might improve the outcome for cancer patients. However, none of this research has been~     confirmed in the peer-reviewed Western scientific literature. Although it is unlikely that~     EQT will result in significant decreases in tumor size, patients are using qigong either as a~     complementary approach, and sometimes even in place of conventional medicine, it is,~     therefore, important for us to determine whether there is any merit to this treatment~     modality. The goal of this pilot trial is to examine one form of medical qigong (external qi~     therapy (EQT)) to determine feasibility. In an exploratory nature we will also examine any~     changes in tumor size in women with breast cancer who are awaiting surgery.~   "
233840|NCT00495196|"~     The purpose of the trial is to investigate the cardiovascular response to peripheral~     chemoreceptor stimulation in Congestive Heart Failure with Cheyne- Stokes Respiration~   "
233841|NCT00495183|"~     The aim of this study is to assess the efficacy of caffeine compared to placebo as a~     maintenance treatment for cocaine dependence. Caffeine potentiation with biperiden will be~     also studied.~      Ninety patients with snorted/sniffed cocaine dependence will be randomized to receive~     caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) caffeine (300 - 1200 mg t.i.d.)~     with placebo or placebo during 10 days in an in-hospital setting.~   "
233842|NCT00495170|"~     The goal of this clinical research study is to learn if proton radiotherapy given with~     standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally~     advanced NSCLC. The safety of this treatment will also be studied.~   "
233843|NCT00495157|"~     Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with~     inhaled corticosteroids often requires periodic adjustments to medication dosing and~     frequency levels. This study examines whether it is more beneficial to adjust corticosteroid~     treatment based on asthma symptoms and/or biomarkers of lung function versus standard medical~     guidelines.~   "
233844|NCT00495144|"~     This is a phase I, multi-center, open-label, dose-escalation study of TH-302 in patients with~     advanced solid tumors. TH-302 is a hypoxia activated product designed to exploit the hypoxic~     nature of tumors. The study is designed to establish the safety including the maximum~     tolerated dose, the pharmacokinetics, and the anti-tumor activity of TH-302.~   "
233845|NCT00495131|"~     Chronic hepatitis C virus (HCV) infection is prevalent in the world, affecting 3% of the~     world's population. The current standard of therapy is pegylated interferon and ribavirin,~     reaching 54-63% of successful rates. In patients with HCV genotype 1 infection, a 48 week~     course of combination therapy has achieved a higher successful rate that a 24 weeks course of~     therapy. However, several studies in Taiwan have shown that a 24 week course of therapy has~     comparable or even better response to a 48 week course of therapy in Western countries.~     Therefore, whether a 48 week course of therapy can achieve a higher response to a 24 week~     course of therapy in Taiwanese patients with genotype 1 HCV infection remains unclear.~   "
233846|NCT00495118|"~     The purpose of this study is to document the long-term safety of 25, 37.5, or 50 mg~     long-acting injectable risperidone given via injection to the gluteal muscle every 2 weeks to~     subjects with schizophrenia or schizoaffective disorder.~   "
233847|NCT00495105|"~     To prevent excess increases in blood pressure in children by providing two servings of dairy~     foods as snacks daily at school. We hypothesize that children who receive the two dairy~     snacks will exhibit significantly less of an increase in blood pressure over six months as~     compared to control children.~   "
233848|NCT00495092|"~     The aim of this study is to assess the efficacy of caffeine compared to placebo in~     detoxifying cocaine dependent patients. Caffeine potentiation with biperiden will be also~     studied.~      108 with cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.)~     plus biperidene (8 mg b.i.d.) or caffeine (300 - 1200 mg t.i.d.) with placebo or placebo~     during 6 months.~      Primary efficacy outcomes will be 1) patient comfort assessed with abstinence symptomatology,~     craving for cocaine and mental status during detoxifying period, 2) study retention and 3)~     cocaine use.~      Brain dopamine system will be assessed thru IBZM-SPECT and the apomorphine test.~   "
233849|NCT00495079|"~     This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating~     Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or~     greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment~     lines of anti-leukemia chemotherapy. The original enrollment target for this study was~     approximately 56 subjects. Per a protocol amendment, enrollment was increased from 56 to 65.~      The primary objective of this study was to evaluate:~      - The efficacy of the study treatment as determined by the rate of CR plus CR with incomplete~     blood count recovery (CRi) in adult subjects with Philadelphia chromosome-negative (Ph-) ALL~     in second relapse or adult subjects with (Ph-) ALL who failed 2 treatment lines of~     anti-leukemia chemotherapy. Subjects must have achieved a CR to at least 1 prior~     anti-leukemia therapy as defined by a leukemia-free interval of ≥ 90 days.~   "
233850|NCT00495066|"~     The primary objective of the study is to provide treatment with Ipilimumab to subjects who~     have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who~     have no alternative treatment options, and whose physicians believe, based upon available~     data on benefit and risk, that it is appropriate to administer Ipilimumab at a dose of 3~     mg/kg induction (with re-induction, if eligible), or for eligible subjects previously~     enrolled in Ipilimumab studies CA184-042, CA184-078, CA184-087, MDX010-16, or MDX010-20.~   "
233886|NCT00494585|"~     The goal of this clinical research study is to find out if CEP-701 can help control~     myelofibrosis (MF). The safety of CEP-701 will also be studied.~   "
233852|NCT00495040|"~     The goal of this clinical research study is to learn if escalated/accelerated proton~     radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side~     effects. The safety of this treatment will also be studied.~      Objectives:~      To assess the therapeutic efficacy and toxicities of proton radiotherapy with~     escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0)~     NSCLC.~      Primary goals:~        1. Improve 2 years progression free survival at the primary site, and~        2. reduce acute and chronic toxicity~      Secondary goals:~        1. Improve disease specific survival at 2 years.~        2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.~        3. Study the role of biomarkers in predicting therapeutic response and toxicities.~   "
233853|NCT00495027|"~     The objective of this randomized control trial is to compare the effectiveness of Stress~     Inoculation Training (SIT), a well researched psychological treatment for Post Traumatic~     Stress Disorder (PTSD), to that of the non-specific standard care provided in primary care~     settings, called Supportive Counseling (SC), on individuals who were exposed to the September~     11, 2001 terrorist attack on the Pentagon, or the immediate aftermath of this attack. Both~     SIT and SC interventions will each be provided in one 2-hour session with eight weeks of~     daily systematic web-based follow up to promote self-help. The primary hypothesis of this~     study is that SIT will reduce the level of PTSD in participants relative to SCand to the~     pre-treatment levels.~   "
233854|NCT00495014|"~     This study represents the second Phase 1 study with GSK376501 and the goal is to further~     evaluate its safety and tolerability. The way the human body processes GSK376501 will also be~     determined.~   "
233855|NCT00494988|"~     This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in~     newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with~     insulin aspart and insulin NPH.~   "
233856|NCT00494975|"~     The purpose of this study was to confirm the efficacy of NB UVB phototherapy in alleviating~     uremic pruritus and investigate the association between improvement of pruritus and change of~     serum parameters, including routine biochemical data, immune profile and dialysis adequacy.~   "
233857|NCT00494962|"~     To determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg~     tablet of lecozotan.~   "
233858|NCT00494949|"~     The purpose of this study is to evaluate the safety and possible effectiveness of Hemospan~     solution in patients undergoing elective orthopedic surgery who receive spinal anesthesia.~   "
233859|NCT00494936|"~     This study will determine the effects that HIV and hepatitis C virus have on thinking~     abilities and whether the viruses affect brain chemistry.~   "
233860|NCT00494923|"~     The Erlangen Glaucoma Registry is a clinical registry for cross sectional and longitudinal~     observation of patients with open angle glaucoma (OAG) or glaucoma suspect, founded in 1991.~     The primary aim is the evaluation of diagnostic and prognostic validity of morphometrical,~     sensory and hemodynamical diagnostic procedures. No therapeutic studies are performed.~   "
233861|NCT00494910|"~     The purpose of this study is to compare two types of group counseling for cancer patients:~     Meaning-Centered counseling and Supportive counseling. Many cancer patients seek counseling~     to help with the emotional burden of their illnesses. Counseling often helps them cope with~     cancer by giving them a place to express their feelings. Meaning-Centered group counseling~     is intended to teach cancer patients how to maintain or even increase a sense of meaning and~     purpose in their lives, despite cancer. Supportive group counseling is intended to help you~     cope with cancer by giving you a place to express your feelings and get support from other~     cancer patients. The purpose of this study is to compare the benefits of these two types of~     counseling approaches for cancer patients.~   "
233862|NCT00494897|"~     The objective of current protocol is try improve the results of chemotherapy treatment in~     patients with ALL wich is not indicated the peripheral stem cell transplant in first~     remission, with an intensive consolidation follow by re-inductions.~   "
233863|NCT00494884|"~     This study will investigate efficacy and safety of vildagliptin in patients with low baseline~     levels starting at an HbA1C level of 6.5% to support convenient early intervention with~     combination therapies. In parallel, morning and evening dosing will be evaluated in this~     patient population for the first time.~   "
233864|NCT00494871|"~     This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke~     prevention in patients with atrial fibrillation (originally described in Japanese).~   "
233865|NCT00494858|"~     This study will compare the effectiveness of two types of cognitive behavioral therapy in~     treating adult women with the dysregulated subtype of bulimia nervosa.~   "
233866|NCT00494845|"~     Among mind-body therapies, there is evidence for an association between pain reduction and~     mindfulness meditation. Mindfulness meditation provides a potentially safe, effective,~     nonpharmacologic, noninvasive, simple method for pain relief and increased function that~     could be used for the frailest older adult. Additionally, mindfulness meditation addresses~     the multiple dimensions that are affected by chronic pain. The primary objective of this~     study is to determine the impact of an 8-week mindfulness-based stress reduction program on~     physical function and pain severity in community dwelling older adults with chronic low back~     pain. Using a randomized controlled experimental design, 80 community dwelling older adults ≥~     age 65 with chronic low back pain will receive either (1) the MBSR program, or (2) an 8-week~     education program. Prior to initiating the program, immediately after the last program~     session, and 6 months later, the following parameters will be assessed: (1) pain severity,~     (2) disability/physical function, (3) objectively measured physical performance, (4)~     psychosocial function (including mood, self-efficacy, self-rated health, coping, stress,~     quality of life (QOL), mindfulness and pain-related fear), (5) sleep, (6) pain-related~     appetite reduction and, (7) time and frequency of meditation. All measures are self-report~     except for the physical performance measure.~   "
233867|NCT00494832|"~     The purposes of this study are:~        1. To evaluate the safety and efficacy of Dexmedetomidine as an adjunct for anesthesia~          during spine surgery and~        2. To investigate the influence of Dexmedetomidine on the evoked potentials.~   "
233887|NCT00494572|"~     The purpose of this study is to determine if montelukast, in addition to standard treatment~     is helpful in treating patients ages 6-18 who are in the hospital because of status~     asthmaticus.~   "
233868|NCT00494819|"~     Background: Attention-Deficit/Hyperactivity Disorder (ADHD), characterized by inattention,~     hyperactivity, and impulsivity, is among the most common neuropsychiatric disorders worldwide~     (5-10% at school age) and in Taiwan (7.5%). The DSM-IV ADHD consists of three subtypes:~     predominantly Inattentive (ADHD-I), predominantly Hyperactivity/Impulsivity (ADHD-H), and~     Combined subtypes (ADHD-C). Although the DSM-IV field trials indicate that the current~     subtypes differ significantly on variables such as age of onset, gender ratio, and level of~     social and academic impairment, little has been addressed whether the DSM-IV subtypes differ~     neuropsychologically. Numerous researches have proved that stimulants (methylphenidate is the~     only stimulant in Taiwan) are the most effective medication in treating ADHD. Although the~     efficacy of methylphenidate on behavioral measures has been established in Taiwan, there is~     no information about neuropsychological measures.~      Specific Aims:~        1. to validate ADHD subtype by neuropsychological measures; and~        2. to investigate the efficacy of methylphenidate on the improvement of executive~          functioning among children with ADHD.~      Subjects and Methods: Participants will consist of 20 children with ADHD-C, 20 with ADHD-I,~     10 with ADHD-H and 50 controls without ADHD in the age range of 7 to 10. The measures include~     the psychiatric interviews (Chinese K-SADS-E), neuropsychological tests (WISC-III,~     Cancellation Test, Digit Span, Trail Making Test, CPT, Circle Tracing Test),~     self-administered rating scale (SNAP-IV), and investigator administered assessment (CGI and~     Behavior Observation Ratings).~      Anticipated Results: We anticipated that children in the ADHD and non-ADHD group will perform~     differently on the neuropsychological tests with more deficits in neuropsychological~     functions in the ADHD group. Also, we expected that methylphenidate will improve the~     performance on the neuropsychological tests and reduce the behavioral symptoms of ADHD~     children. Subtypes difference in the neuropsychological functions is also expected.~   "
233869|NCT00494806|"~     Primary Objective:~      1. Compare the duration of postoperative ileus (POI) duration (time to first flatus),~     subjective reports of surgical and gas pain, postoperative pain medication (total milligrams~     per 24 hours) and postoperative recovery time(length of stay) between two groups of abdominal~     surgery cancer patients receiving either standard postoperative care or standard care plus~     the rocking intervention.~   "
233870|NCT00494793|"~     The purpose of this multicenter trial is to prospectively evaluate a novel combination of~     vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open~     abdomens.~   "
233871|NCT00494780|"~     To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP~     (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients~     with Follicular Lymphoma (FL)~   "
233872|NCT00494767|"~     The drugs GSK189075 and GW869682 result in increased caloric losses. This study is~     investigating how if taken over 8 weeks that affects weight loss, food intake and the~     composition of the body. The body composition (fat,water, lean mass) is determined using a~     new investigational MR technology.~   "
233873|NCT00494754|"~     The purpose of this study is to prepare instruments for Autism Spectrum Disorder (ASD), to~     collect clinical, neuropsychological, and genetic data of ASD probands and their family, and~     to identify the genetic variants close to etiological genes of ASD in a Taiwanese sample~   "
233874|NCT00494741|"~     The Mycophenolate Steroid Sparing (MYSS) study demonstrated that, in the setting of a~     maintenance immunosuppressive regimen without steroids, mycophenolate mofetil (MMF) and~     azathioprine (AZA) provided the same efficacy in preventing acute rejection episodes and~     allograft dysfunction in kidney transplant recipients. Induction therapy with basiliximab~     combined with low-dose thymoglobulin (RATG), through a transient depletion/inhibition of T~     lymphocytes, allows further reducing the need for maintenance immunosuppression.~      Aim of the present study is to assess whether under this induction strategy MMF and AZA are~     equally effective in preventing acute rejection and chronic allograft nephropathy (CAN), even~     after cyclosporine (CsA) withdrawal.~      Two-hundred-twenty-four kidney transplant recipients from deceased donors given induction~     therapy with two 20 mg basiliximab injections 4 days apart and a seven-day course of RATG~     (0.5 mg/kg/day), will be randomly allocated on a 1:1 basis to 3-year treatment with low-dose~     MMF or AZA, added-on CsA maintenance therapy. At 1 year, rejection-free patients with no~     evidence of tubulitis at kidney biopsy will withdraw CsA and will have a kidney biopsy 3 year~     post-transplant for evaluating the presence and severity of CAN. Should the cumulative~     incidence of acute rejection exceed 15% during CsA withdrawal the study will be stopped.~     Should the incidence differ by >30% between the two treatment arms, all patients will be~     given the most effective treatment and the follow up will be continued. A final biopsy will~     be repeated 4 years post-transplant.~      Most patients are expected to be effectively maintained on single drug immunosuppression,~     which implies less steroid- and CsA- related complications and treatment costs. MMF is~     expected to prevent CAN more effectively than AZA. However, should AZA be more or as~     effective compared to MMF, at study end all patients could be shifted to AZA, that is 15-fold~     less expensive than MMF. Extended to clinical practice, these findings should translate in~     improved patient care and major cost-savings for the Health Care System.~   "
233875|NCT00494728|"~     Objectives:~      Primary Aim:~      To conduct a preliminary randomized trial in smokers with current recurrent major depressive~     disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia~     comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard~     smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment~     (HE/ST) to:~      1. Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence~      Secondary Aims:~        1. To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience~          greater decreases in depressive symptoms from baseline to each of our follow-up~          assessment points, compared to depressed smokers in the HE/ST treatment, and;~        2. That depressed smokers in the CBASP/ST treatment will experience greater improvements in~          psychosocial functioning from baseline to follow-up assessment points, compared to~          depressed smokers in the ST treatment.~        3. To evaluate between subject neurophysiological predictors of abstinence at 3 and 6~          months, and:~        4. To evaluate within-subject changes in neurophysiological responses to emotional and~          smoking-related stimuli across treatment sessions, and the relation of these changes to~          abstinence and depressive symptoms at end of treatment, and 3- and 6-months.~   "
233876|NCT00494715|"~     Nephropathy of type 2 diabetes is the leading cause of end stage renal disease (ESRD)~     world-wide and is associated with a dramatic excess cardiovascular morbidity and mortality.~     Two randomized trials found that angiotensin II receptor blockers (ARBs) reduce the incidence~     of ESRD by about 30%, but have no appreciable effects on cardiovascular mortality. Available~     data suggest that ACE inhibitors might be similarly renoprotective and even more~     cardioprotective, but large scale trials on ACE inhibitors, alone or combined with ARBs, in~     overt nephropathy of type 2 diabetes are missing.~      This study will compare the effects, at comparable blood pressure control (systolic/diastolic~     <130/80 mmHg), of dual renin-angiotensin-system (RAS) blockade by half dose of benazepril and~     valsartan combination therapy as compared to single RAS blockade by benazepril or valsartan~     alone at full dose, 20 mg and 160 mg respectively, on ESRD and cardiovascular events in~     high-risk patients with type 2 diabetes and overt nephropathy, defined as serum creatinine~     >1.8 mg/dl and < 3.2 mg/dl and spot morning urine albumin to creatinine ratio >1000mg/g for~     the patients without previous ACE inhibitor and ARB therapy and >500mg/g for the patients~     with previous ACE inhibitor or ARB therapy and no specific contraindications to the study~     drugs. The relationships between renal and cardiovascular outcomes will also be evaluated.~      102 patients will be treated for at least 3 years. At comparable blood pressure control, the~     study is expected to show a more effective reduction in ESRD and cardiovascular events with~     combined than with single drug ACE inhibitor or ARB therapy. As compared to ARB, ACE~     inhibitor therapy is expected to have a similar effect on ESRD, but a superior~     cardioprotective effect. Applied to clinical practice, the findings should help reducing~     renal and cardiovascular complications, and related treatment costs, of type 2 diabetes.~   "
233877|NCT00494702|"~     The investigators hypothesize that using low oxygen concentrations during resuscitation of~     extremely premature infants will avoid oxidative stress derived damage and improve outcome.~   "
233878|NCT00494689|"~     The investigator(neurologist) has published a study in International Congress Series, in the~     15th International Conference of Biomagnetism Vancouver Proceedings 2006,and Science Direct~     website, of 15 patients with brain ischemia and dilated ventricles who improve when treated~     with transcranial monitoring or low ultrasound wave intensity (milliwatts) and with rapid~     magnetic stimulation which is also a diagnostic tool routinely used by many~     neurophysiologists. Before, these patients will progress and may need a brain shunt called~     Ventriculo-peritoneal shunt. He and collaborators now would like to do a double study as this~     appears to be a cheap and effective alternative treatment and help patients to walk again.~   "
233879|NCT00494676|"~     The purpose of this study is to evaluate the functional utility for general mobility~     (walking) of new high power permanent peripheral prism glasses, which provide visual field~     expansion device for patients with homonymous hemianopia (the complete loss of half the field~     of vision on the same side in both eyes). The efficacy of real peripheral prism glasses will~     be assessed relative to sham peripheral prism glasses.~   "
233880|NCT00494663|"~     DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the~     ketoconazole molecule for the treatment of elevated blood glucose associated with type 2~     diabetes mellitus. Ketoconazole (Nizoral®) is a drug available by prescription for the~     treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower~     blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated~     cortisol may contribute to the development of type 2 diabetes.~      The purpose of this research study is to test the safety of DIO-902 when taken by mouth with~     metformin and the cholesterol-lowering drug atorvastatin to determine the type and severity~     of any side effects from this treatment.~      Other purposes of the study are to see how the treatment affects your blood glucose levels,~     cholesterol levels, blood pressure, and waist circumference.~   "
233881|NCT00494650|"~     This study will evaluate the effectiveness of tailored cognitive behavioral therapy in~     treating post-traumatic stress disorder in people with additional mental illnesses.~   "
233882|NCT00494637|"~     Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the~     risk of contrast induced nephropathy with coronary angiography. The investigators plan to~     randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary~     angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate~     beginning one hour before the procedure and for four hours after. The primary endpoint is the~     development of contrast nephropathy within 48-72 hours after the procedure. Patients with an~     ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.~   "
233883|NCT00494624|"~     We can not predict which wheezing child younger than 3 years of age benefits from systemic~     glucocorticoid and which one does not. It is not known whether the differences in the~     efficacy are related to the differences in viral etiology, atopy, immunogical maturity or age~     of the patient. The study aims to answer the following questions: 1. What is the viral~     etiology of acute childhood expiratory wheezing? 2. What is the efficacy of prednisolone in~     relation to age, atopy and viral etiology in acute childhood wheezing? 3. Does prednisolone~     treatment increase risk for secundary bacterial infection in acute childhood expiratory~     wheezing? 4. What is the significance of inflammatory markers in predicting the efficacy of~     systemic steroid or patient outcome in acute childhood expiratory wheezing? Study will follow~     randomized, double blind, placebo-controlled parallel design. Study will start in Septemper~     2000 and will be performed at the Department of Pediatrics, Turku University Hospital, Turku~     Finland. The study population will be 300 hospitalized wheezing children aged 3 months – 15~     years. Investigational drug will be prednisolone, first dose 2 mg/kg, then 2 mg/kg/d/3 (max.~     60 mg/vrk) p.o. for 3 d and comparative drug will be placebo tablet similar to~     investigational drug with the equal dosage. The primary outcome will be the time until ready~     for discharge. The study will provide new and important information for the diagnostics,~     treatment, disease outcome and prevention of acute childhood expiratory wheezing.~   "
233884|NCT00494611|"~     There are more than 140,000 new cases of colon cancer diagnosed each year, and over 60,000~     Americans die from colon cancer annually. To date, surgical resection remains the mainstay of~     treatment for colon cancer. However, between 35% and 45% of patients, despite colon surgery,~     retain unseen tumor cells in the bloodstream or in small clumps in the liver or other~     tissues. It is for this reason that postoperative chemotherapy (anti-tumor drugs) is~     recommended and given to some patients after surgery. Conventional chemotherapy is usually~     started no earlier than 4 to 6 weeks after the colon cancer has been resected.~      Despite surgery and conventional chemotherapy, a significant number of patients develop~     cancer recurrences and many go on to die from the cancer. For this reason, investigators~     continue to look for new cancer treatments and approaches. The study under consideration~     proposes to give colon cancer patients an anti-cancer therapy for 3 weeks before and for 3~     weeks after undergoing operation to remove the colon cancer. This time period is referred to~     as the perioperative period. Presently, around the world, doctors do not administer any~     type of anti-cancer therapy during the perioperative period. It is the belief of the~     investigators carrying out this study that this period may be an ideal time to fight the~     tumor and that treatment given during this time may improve survival and reduce cancer~     recurrence rates. Patients who choose to receive this biologic anti-cancer treatment~     immediately before and after surgery can also receive conventional chemotherapy at the usual~     time (4-6 weeks after surgery). Thus, this perioperative anti-cancer treatment would not~     interfere with the standard chemotherapy regimens used today.~      The drug that is to be given in this study is called Cetuximab (also known as Erbitux).~     This is an anti-cancer drug which has already been approved by the FDA for use in patients~     who have colon cancer. This drug, like all of the other anti-cancer drugs used for treating~     colon cancer, has been given either well after surgery or to patients with very advanced~     disease who have not undergo surgery. What is unique about the St. Luke's Roosevelt study is~     that the drug will be given during the 3 weeks before surgery and for the first 3 weeks after~     the colon resection surgery.~      To summarize, Cetuximab is a humanized antibody to EGFR which has been shown to be effective~     in killing tumor cells in patients with colon cancer.~      In this study the Cetuximab is to be given 1) after the surgery, 2) immediately before the~     operation, or 3) both before and after surgery. Entry into the study means that the operation~     may be delayed for at least 3 weeks in order for the drug to be given. Since many patients~     who do not participate in any research studies wait at least that long for surgery this does~     not constitute a delay. The drug has a safety profile and has been well tolerated, in~     general. However, since thus far it has not been given in the weeks immediately prior to or~     immediately after major surgery there is no safety profile for this drug during the~     perioperative period. The primary goals of this preliminary study are to establish the safety~     of Cetuximab in the perioperative period and to demonstrate that the preoperative doses have~     an actual impact on the tumor cells themselves.~   "
233885|NCT00494598|"~     There is a need to understand how long anesthetic drugs last in the brain during surgery on~     the ascending aorta or aortic arch. Drugs can have a prolonged effect when blood temperature~     is made cold therefore the influence of temperature needs to be studied. This type of surgery~     allows us to answer questions about how anesthetic drugs behave when they are given during a~     routine portion of surgery. Patients will be provided with anesthetic drugs during surgery~     while on a heart lung machine. After the drug is injected into the heart lung machine it will~     be delivered to the brain to provide more sleep and pain relief. Immediately after the~     injection of anesthetic drugs, blood samples will be taken from an existing intravenous line~     in the neck and plasma drug concentrations measured. This will help us to understand how long~     drugs last in the brain during this type of surgery.~   "
233888|NCT00494559|"~     People with diabetes mellitus are more prone to coronary heart disease, stroke, and~     peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk~     factor for the progression of coronary artery disease. Several studies have been reported~     that diabetes increased the risk of cardiovascular mortality in both men and women. With the~     introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later~     months have reduced dramatically in several studies. However, even with DESs, diabetic~     patients showed increased rates of restenosis and late loss index compared with nondiabetic~     patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous~     coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes~     after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been~     demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era~     of DESs, no study has demonstrated the clinical and angiographic outcomes in diabetic~     patients after zotarolimus-eluting stent implantation by using intravascular ultrasound~     (IVUS).~      Pioglitazone is used in the treatment of diabetic patients. Thiazolidinediones increase~     insulin sensitivity and show favorable effect on blood glucose levels and lipid profiles. The~     effect of pioglitazone on neointima volume and inflammatory markers has not been compared in~     prospective manner after zotarolimus-eluting stent implantation. The purpose of this~     prospective, randomized, single blinded trial is to compare the effect of pioglitazone on~     inflammatory markers and neointima volume by using IVUS in diabetic patients.~   "
233889|NCT00494546|"~     Objective: The objective of this study is test the hypothesis that delivering a higher~     percentage of the radiation dose as external radiation versus implant will lead to higher~     tumor control rates.~      Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma~     (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy~     versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy,~     respectively).~   "
233890|NCT00494533|"~     Multi-center, double-blind, placebo-controlled, randomized, parallel study comparing~     continuous intravenous (IV) Remodulin® to placebo in patients with pulmonary arterial~     hypertension either primary (PPH) or associated with human immunodeficiency virus (HIV)~     infection or collagen vascular disease).~   "
233891|NCT00494520|"~     Adults who sustain brain damage due to stroke, traumatic injury or surgery may develop~     difficulty finding words. This study compares the effectiveness of two behavior-based~     programs to improve picture naming ability in these individuals.~   "
233892|NCT00494507|"~     The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance)~     for prevention of episodes and for improvement of strength in hyperkalemic (HYP) and~     hypokalemic (HOP) periodic paralysis. This study will also look at the long-term effects of~     Dichlorphenamide in periodic paralysis.~   "
233893|NCT00494494|"~     Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative~     cystoid macular edema following uncomplicated cataract surgery~      Participants: Patients having cataract surgery at UNC who meet eligibility criteria~      Procedures (methods): Patients will have pre and post-operative vision measured and optical~     coherence tomography (OCT) testing, also cataract density and intraoperative~     phacoemulsification parameters including ultrasound power and ultrasound time will be~     measured. Patients will be randomized into two groups. Group 1 will be treated with standard~     post-operative cataract management. Group 2 will be treated with standard post-operative~     cataract management plus topical nepafenac for one month. Post-operative macular thickness~     will be studied by analyzing the visual acuity and OCT measurements at two months post~     surgery.~   "
233894|NCT00494481|"~     To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using~     the progression event count methodology~   "
233895|NCT00494468|"~     This is a multicenter trial to evaluate the single-dose safety, tolerability and~     pharmacokinetics-pharmacodynamics of Zolpidem in a group of children with sleep disturbances~     stratified by age and dose.~   "
233896|NCT00494455|"~     The purpose of this study is to determine whether subcutaneous continuous glucose monitoring~     in critically ill patients is clinically feasible accurate and reliable.~   "
233897|NCT00494442|"~     The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in~     treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for~     whom no curative therapeutic option exists.~   "
233898|NCT00494429|"~     The purpose of this study is to improve the dosing of morphine in critically ill premature~     neonates.~   "
233899|NCT00494416|"~     IPT/SP was adopted in 2005 by The Ministry of Health (MoH) of Burkina Faso to replace~     chemoprophylaxis with CQ in pregnancy. The new strategy is being implemented but no delivery~     approach was defined and presumably IPT/SP will only be delivered to pregnant women~     presenting at ANC visits. It would be of extreme importance to ensure a better coverage and~     higher compliance to make the new strategy effective. In order to obtain a more efficient~     IPT/SP programme with a good level of compliance and coverage, several delivery approaches~     beside ANC should be explored.~      The study site will be in Pissy health district covering both peri-urban Ouagadougou city and~     rural areas. Participants include pregnant women irrespective of gravidity residing in the~     study area.~      The study is a prospective comparative study of 3 different approaches of delivering IPT/SP~     in the catchment areas of rural health facilities. The approaches will be the following:~        1. Passive health centre based delivery approach (PHC). IPT/SP will be delivered to~          pregnant women presenting to the health centre for ANC visits.~        2. Joint, with an advanced strategies delivery approach (JAS). In addition to passive~          delivery at health centres, the pregnant women will be reached during preventive~          activities the health staff carry out regularly in villages, such as immunization,~          health promotion, and even ANC visits.~        3. Community based distribution delivery approach (CBD). In addition to passive delivery at~          health centres, the pregnant women will be reached by traditional birth attendants~          (TBAs) or representatives of village women's associations (RWAs). Each approach will be~          implemented in a zone constituted by the catchment area of a number of health centres to~          achieve the required sample size. The zones will be randomly assigned to a delivery~          approach. The main outcomes to be measured are: a) the coverage of IPT, b) compliance,~          c) infection prevalence, d) Hb level, e) difficulties and constraints of each approach,~          f) the acceptability to population and health staff and g) the performance of each~          approach to deliver IPT /SP. to be able to identify a significant increase in coverage~          of 10%, each group should be composed of n = 3841 pregnant women.~      Cross sectional surveys will be carried out at the beginning, during and at the end of the~     study period. The study will be carried out over 24 months from June 2007.~   "
233900|NCT00494403|"~     The purpose of this investigation is to determine the effects of chronic ankle instability on~     cervical spine and knee proprioception as measured using joint position sense to investigate~     whether correlation can be drawn between the two.~   "
233901|NCT00494390|"~     The purpose of this study is to determine whether a new non-contact biometer, is as accurate~     as the the available gold-standard.~   "
233902|NCT00494377|"~     The primary purpose of this study is to determine if duloxetine plus non-drug intervention is~     more effective than duloxetine alone in patients with depression.~   "
233903|NCT00494364|"~     The middle ear is an airspace located behind the eardrum that consists of two connecting~     compartments. The compartment directly behind the eardrum is called the tympanum and contains~     the three small bones of the middle ear, the hammer, anvil and stapes, that function to~     transfer eardrum movements to the inner ear so that you can hear. Behind the tympanum is the~     mastoid cavity which is a larger airspace subdivided into small air cells of unknown~     function. For normal hearing, it is important that the air pressure in the middle ear is~     similar to that of the environment so that the eardrum can move freely in response to sounds.~     The air pressure of the environment is not constant and is affected by changes in weather~     conditions (high and low pressure systems that move through the area) and by changes in~     elevation above sea level (the fullness in your ears that can be noticed when you ride in an~     elevator or in an airplane). The air pressure in the middle ear also changes because middle~     ear gas is constantly leaking from that airspace to the blood that flows through the walls of~     the middle ear. These effects (changing environmental air pressures and changing middle ear~     air pressure) are independent and cause the middle ear and environmental pressures to be~     different from each other. Periodically and during swallowing or yawning, any existing~     difference between middle ear and environmental air pressure is reset to zero by the opening~     of a biological tube (the Eustachian tube) that connects the middle ear to the back of the~     nose. This allows gas flow between the middle ear and the environment which increases or~     decreases middle ear pressure to the level in the environment at that time. Most people~     cannot open their Eustachian tubes at will and the number of automatic openings varies from~     infrequent to often in a population. Whether or not a person's usual frequency of Eustachian~     openings is good enough to keep the middle ear pressure the same as environmental levels~     depends on how fast gas is lost from the middle ear by gas leakage (diffusion) to blood. For~     example, in ears with very slow rates of gas loss, the Eustachian tube does not need to open~     very frequently to keep the middle ear at environmental pressure. Some researchers believe~     that the mastoid compartment functions to control the rate of gas loss to blood, with larger~     mastoid volumes associated with lesser rates of middle ear gas loss. In this experiment, the~     investigators plan to test this by measuring mastoid and tympanum volumes using Computer~     tomography (CT) and the rate of blood to middle ear gas transfer using a technique that~     involves breathing air that contains laughing gas (Nitrous Oxide=N2O) and measuring middle~     ear pressure change using tympanometry (a technique that involves putting an ear plug into~     the ear canal and measuring the pressure). From past studies in patients undergoing short~     surgical or dental procedures, the investigators know that breathing gas mixtures that~     contain N2O will increase the blood levels of that gas, cause gas to go from blood to the~     middle ear and increase middle ear pressure. The investigators predict that the rate of~     change in middle ear pressure while breathing a gas mixture containing 25% N2O and the normal~     oxygen level (20%) of air will be less for those ears with larger mastoid volumes. If the~     investigators prediction is correct, they will be able to explain why ears with larger~     mastoid volumes are better able to keep their pressure like that of the environment even if~     the Eustachian tube does not open often.~   "
233904|NCT00494351|"~     -  Determination of the short and long term efficacy of NdYag laser for treatment of~          Hidradenitis suppurativa, which is an inflamed, deeper follicular disorders.~        -  Determination of patient tolerance of discomfort associated with NdYag laser treatment~          for Hidradenitis suppurativa.~        -  Determination of the impact of this condition on quality of life and if there is any~          impact of therapy in the dermatology quality of life index.~        -  Evaluate the histopathologic changes of YAG therapy on affected skin~      Second phase of study:~        -  Prospective, controlled clinical and histologic study of patients with Hurley Stage II~          HS disease.~        -  19 patients of skin types II to VI with Hurley Stage II hidradenitis suppurativa lesions~          of the axilla and groin. This is a different set of patients than those treated in the~          first phase of the study above. This study primarily focuses on and further~          characterizes the histologic changes after laser treatment.~   "
233905|NCT00494338|"~     A multi-center controlled, non-comparative open Phase II trial of docetaxel and celecoxib in~     patients with metastatic androgen independent prostate cancer where efficacy is measured by~     PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at~     least 4 weeks apart.~   "
233906|NCT00494325|"~     In the industrialised world age-related macular degeneration (ARMD) is the leading cause for~     legal blindness beyond the age of 50 years. Recent studies indicate that the amount and~     status of the macular pigment (MP) may play a central role in the development and progression~     of the disease. It has been demonstrated that the MP density can be increased by dietary~     supplementation. First results of MP density measurements with a modified confocal laser~     scanning ophthalmoscope show that this method allows to quantify the MP in a clinical~     setting. The aim of this study is to assess the peak MP density as well as the MP~     distribution in relation to the risk for ARMD. We will establish reference values for MP~     density distribution in a normal population and compare these to values obtained from~     patients with age related maculopathy in a cross-sectional study. For all MP density~     measurements we will use a modified scanning laser ophthalmoscope and dietary intake of~     macular pigment will be assessed using a Food Frequency Questionnaire. Clinical examinations~     will include ETDRS visual acuity, binocular ophthalmoscopy, colour fundus photography and~     autofluorescence imaging. The results of our study will help assess the relationship of~     macular pigment density and distribution with ARMD. Additionally, we will be able to identify~     patients with low MP density, and probably improve the early diagnosis of patients at high~     risk for developing ARMD. This will be the basis for dietary supplementation of lutein and/or~     zeaxanthin in patients with high risk for ARMD due to low macular pigment values.~   "
233907|NCT00494312|"~     The purpose of this study is to determine the liver safety of pioglitazone, once daily (QD),~     versus glyburide taken with metformin and insulin.~   "
233908|NCT00494299|"~     Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.~   "
233909|NCT00494286|"~     This study will determine the effectiveness of abuse-focused cognitive behavioral therapy~     that is provided by a community health clinic in addressing the behavioral and emotional~     health needs of children and adolescents whose parents have used physical disciplinary~     action.~   "
233910|NCT00494273|"~     There has not been a great deal of research involving Haitian American adolescents and HIV~     risk reduction. The purpose of the study is to learn better ways to teach teenagers about~     living healthy by educating these children about how to make good choices about things like~     eating healthy, exercise, and sexual behavior. The primary focus of the proposed study is to~     understand the mechanisms of adopting safer sex practices among Haitian American (H-A)~     adolescents. We will enroll 160 male and 160 female participants to achieve the target sample~     of 272 participants at the 12-month follow-up time point.~   "
233911|NCT00494260|"~     The purpose of this study is to evaluate the efficacy of a social learning and cognitive~     behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).~   "
233912|NCT00494247|"~     Randomized prospective study to compare the efficiency and safety of EPC-capture stents~     (Genous, OrbusNeich) and bare metal stents with concommitant high dose atorvastatin in~     reduction of neointimal formation assessed by quantitative coronary angiography and IVUS.~     Also the association between the function (transcriptional activity, migration) and number of~     circulating EPCs and angiographic outcomes will be investigated.~   "
233913|NCT00494234|"~     The purpose of the study is to see if the drug KU 0059436 (olaparib) is effective and well~     tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced breast~     cancer and for whom no curative therapeutic option exists.~   "
233914|NCT00494221|"~     This Study is in two parts, the first part is to make sure that combining a potential new~     treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal~     cancer is safe. Once this part is complete and it is decided that it is safe to continue the~     Study will the go on to look at the efficacy of the two drugs together. This will be done by~     studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy~     cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real~     cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that~     non-one can tell the difference between the two treatment groups. This kind of study design~     is done to try to avoid the chance that the results might be biased in some way. The overall~     aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard~     treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results.~     That is, it's better than giving standard treatment alone in helping to prevent progression~     of mCRC.~   "
233928|NCT00494026|"~     This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed +~     carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell~     lung cancer~   "
233929|NCT00494013|"~     The purpose of this study is to examine the effectiveness and safety of insulin lispro~     protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults~     with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the~     secondary objectives.~   "
233942|NCT00493831|"~     The purpose of this prospective, open-label, clinical trial is to establish the feasibility~     and validity of exhaled breath condensate (EBC) biomarkers for use in studies designed to~     evaluate harm reduction strategies of smoking. This will be accomplished by measuring~     selected markers in EBC believed related to the pathogenesis of lung disease before and after~     a smoking cessation intervention.~   "
233915|NCT00494208|"~     TDSM will study the physiology of testosterone in women ages 21-60 who have had surgical~     menopause (uterus and both ovaries removed). Testosterone is commonly thought of as a male~     hormone thus being that it is the male's primary hormone. Women produce testosterone in much~     smaller amounts and despite this, testosterone still plays a significant role. Fifty percent~     of a women's testosterone is made in her adrenal glands (glands that sit on top of the~     kidneys) and fifty percent is made in her ovaries. When a woman has her ovaries removed it is~     thought that her testosterone levels decrease rapidly and significantly. This study will be~     examining testosterone's role in sexual function, general well being, muscle performance,~     cognitive function, carbohydrate metabolism and muscle and fat distribution.~      The study is 14 months long with weekly to monthly visits. The subjects will be placed on the~     estrogen patch for the duration of the study. They will also be given weekly injections of~     testosterone or placebo for 6 months. During the testosterone treatment phase the women will~     be separated into 5 groups. The groups include a dose of testosterone that is very low, low,~     medium, high and placebo. A placebo looks and feels similar to testosterone; however it does~     not have testosterone in it. We use this to test if the subject is having a response to the~     testosterone itself or the thought of receiving testosterone. Neither the subject nor the~     investigators will know the dose until the end of the study.~   "
233916|NCT00494195|"~     Limb girdle muscular dystrophy type 2D (LGMD2D) is a genetic disease that affects skeletal~     muscle. Insufficient levels of the protein alpha-sarcoglycan result in muscle weakness that~     worsens over time. The purpose of this study is to evaluate the safety and effectiveness of~     gene therapy in treating children and adults with LGMD2D.~   "
233917|NCT00494182|"~     The goal of this clinical research study is to learn if the combination of carboplatin,~     paclitaxel, and sorafenib can help to control the disease in patients with head and neck~     cancer. The safety of this drug will also be studied.~   "
233918|NCT00494169|"~     The aims of this study are: 1) to identify genes that play a role in human pubertal~     development and reproduction, 2) to characterize the phenotypic spectrum of patients with~     these gene defects, and 3) to discern the mode of inheritance for disorders caused by these~     gene defects. We are specifically interested in genes that cause Kallmann syndrome,~     idiopathic hypogonadotropic hypogonadism (IHH), precocious (early) puberty, and delayed~     puberty. Individuals do not have to travel to Boston to participate in this study.~   "
233919|NCT00494156|"~     Originally thought to be a rare occurrence, BCVI are now diagnosed in approximately 1% of~     blunt trauma patients. Initially BCVI were thought to have unavoidable devastating neurologic~     outcomes. But early reports suggested anticoagulation might decrease these events. If~     untreated, carotid artery injuries (CAI) have a stoke rate up to 50% depending on injury~     grade, with increasing stroke rates correlating with increasing grades of injury. Current~     studies report early treatment with antithrombotics - either heparin or anti-platelet agents~     - in patients with BCVI markedly reduces stroke rates and resultant neurologic morbidity. As~     reports of bleeding complications have altered heparin protocols in these patients, the use~     of antiplatelet agents is attractive. Although heparin has been has been proposed as the gold~     standard treatment due to its initial empiric use, no comparative studies of antithrombotic~     agents has been performed.~      In sum, Grade I-III blunt carotid and vertebral arterial injuries (BCVI) have the potential~     for stroke, and should be treated. Heparin has not been shown to clearly improve healing~     rates compared with antiplatelet therapy. The purpose of this study is to determine whether~     systemic anticoagulation alters the course of Grade I-III BCVI compared with antiplatelet~     therapy. The investigators study hypothesis is that Grade I-III BCVI will heal or progress to~     pseudoaneurysm formation, independent of systemic antithrombotic regimen, and that the~     combination of aspirin and clopidogrel is equally efficacious in preventing neurologic~     symptoms compared to systemic heparin associated with Grade I-III BCVI.~   "
233920|NCT00494143|"~     To determine if below-knee amputees will walk with better efficiency wearing a CESR foot~     which stores energy at heel strike and releases energy releases energy during push-off.~   "
233921|NCT00494117|"~     The purpose of the study is to investigate respiratory indicators for clinically important~     changes in Heart Failure status over time.~   "
233922|NCT00494104|"~     Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D~     deficiency during winter. This trial is designed to determine how much supplemental vitamin D~     breastfed infants need to receive in order to remain free of vitamin D deficiency~   "
233923|NCT00494091|"~     This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in~     Asian patients with advanced renal cell carcinoma. The trial is only being conducted in~     Japan, Korea, and China.~   "
233924|NCT00494078|"~     The purpose of this study is to determine whether, real-time continuous glucose monitoring in~     critically ill patients with intensive insulin therapy would increase the percentage of time~     of normoglycemia, defined as glucose levels below 110 mg/dl.~   "
233925|NCT00494065|"~     The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal~     Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192~     patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term~     (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and~     secondary outcome variables include low back pain, disability, bothersomeness and frequency~     of symptoms, general health status, and fear avoidance behavior.~      Secondary aims are to describe and estimate between group differences in patient~     satisfaction, improvement, medication use, straight leg raise, torso endurance, and three~     biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response~     to sudden load. Patient perceptions of treatment will also be assessed.~   "
233926|NCT00494052|"~     Coronary heart disease (CHD) is the leading cause of death in the United States, but fewer~     than half of all individuals at risk for CHD take advantage of proven strategies to lower~     their chances of developing this disease. This study will assess the effectiveness of Heart~     to Heart, a Web-based program, at educating people on ways to incorporate CHD risk-reduction~     strategies into their lives.~   "
233927|NCT00494039|"~     Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will~     increase the rate of tumor eradication.~      Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma~     (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160~     Gy) versus Pd-103 (115 Gy).~   "
233930|NCT00493987|"~     In normal men, the male hormone testosterone affects a number of things in the body including~     muscle function and sexual function. An enzyme in the body called 5-alpha reductase converts~     testosterone into another form called dihydrotestosterone (DHT) which has slightly different~     effects. The purpose of this study is to find out how different amounts of the two different~     forms of testosterone affect muscle function and sexual function in healthy young men like~     you. This will be done by giving the men participating in the study different combinations of~     hormone-related medication for 20 weeks and making measurements before, during and after the~     medications to look for changes in lean body tissue, muscle size, muscle strength and leg~     power, as well as sexual function and sexual activity in all participants.~   "
233931|NCT00493974|"~     Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by~     cigarette smoking or by breathing in other lung irritants, including pollution, dust, or~     chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a~     medication that is used to control asthma symptoms, at reducing the length of a hospital stay~     for adults who are hospitalized for a COPD exacerbation, or worsening of COPD symptoms.~   "
233932|NCT00493961|"~     Men with Idiopathic Hypogonadotropic Hypogonadism (IHH) lack a hormone called gonadotropin~     releasing hormone (GnRH). This hormone is important for starting puberty, maintaining~     testosterone levels, and fertility. The purpose of this study is to research the effects of~     treating IHH men with GnRH for 7 days.~   "
233933|NCT00493948|"~     The purpose of this study is to evaluate an approved, portable device for assessing Sleep~     Disordered Breathing in Congestive Heart Failure.~   "
233934|NCT00493935|"~     Low blood sugar at night (called nocturnal hypoglycemia), can often happen without symptoms~     and can last for a long time. Doctors often suggest that patients take a bedtime snack to try~     to prevent low blood sugar at night from happening, but it is not known what type of snack is~     best to take. We are conducting a study to evaluate how two different types of snacks affect~     how often the blood sugar is too low overnight. One snack will be a primarily carbohydrate~     snack and the other will be a carbohydrate snack with fat. The snacks will be provided by the~     study.~      As part of the study, a continuous glucose sensor (the Freestyle Navigator) will be worn~     overnight. The Freestyle Navigator was developed by Abbott Diabetes Care. This sensor uses a~     glucose oxidase based electrochemical sensor, and is designed to measure blood glucose levels~     in a range of 20-500 mg/dl. The sensor is inserted subcutaneously and measures interstitial~     glucose. In human studies the interstitial glucose levels generally lag behind the blood~     glucose by 3 to13 minutes.(27, 28)~      The Freestyle Navigator, provides a glucose reading every 60 seconds (or 1440 readings a~     day). Each sensor is designed to provide readings for up to 120 hours. It has alarms for~     hypoglycemia and hyperglycemia and for projected high and low glucose values. The alarm set~     points can be adjusted by the user. The Navigator also has a trend arrow indicating the~     glucose rate of change (>-2 mg/dL/min, -2 to -1 mg/dL/min, -1 to 1 mg/dL/min, 1 to 2~     mg/dl/min, and >2 mg/dl/min). Subjects can enter events, such as when they took insulin, ate,~     or exercised. The sensor requires calibration values to be entered 3 times during the first~     day of wear, and then 2 additional times during the 5-day wear period. The values are entered~     directly into the Navigator which has a Freestyle home glucose meter built into the unit. The~     Navigator has not yet been approved by the FDA. The Navigator currently under review by the~     FDA will limit sensor wear to 3 days.~      This study is being done to see if there is a difference in low blood sugar overnight after~     having a bedtime snack made up of carbohydrate compared to a carbohydrate snack with more~     fat.~   "
233935|NCT00493922|"~     1) To compare in a setting where microscopy for malaria is available whether introducing~     rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT~     v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not~     available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial~     drugs and antibiotics (RDT v clinical diagnosis).~   "
233936|NCT00493909|"~     The purpose of this study is to compare whether epidural analgesia would provide equal~     analgesia than combining intrathecal opioids with thoracic paravertebral local anesthetics.~   "
233937|NCT00493896|"~     This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding~     and development of thrombocytopenia in the medical ICU population.~   "
233938|NCT00493883|"~     The purpose of this study is to provide supervised access to treatment with TheraSphere® to~     eligible patients with primary and metastatic cancer and evaluate response to treatment,~     survival and toxicity.~      The study has the following objectives:~        -  Provide supervised access to treatment with TheraSphere to eligible patients with~          primary and metastatic cancer to the liver.~        -  Evaluate patient experience and toxicities associated with TheraSphere treatment~        -  Evaluate predisposing factors that may influence results and toxicity~   "
233939|NCT00493870|"~     The purpose of this research study is to find out what effects (good and bad) TC or TAC has~     on early stage HER2- breast cancer.~   "
233940|NCT00493857|"~     This study will determine if nimotuzumab provides a benefit in this type of cancer when given~     in combination with irinotecan.~      The study will test:~        -  How long any good effects last.~        -  How bad any side effects are.~      Objectives:~      Primary:~      The primary goal is to assess the Objective Response Rate (ORR) that the combination of~     irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic~     colorectal cancer~      Secondary:~        -  To assess the incidence of Grade 2 or greater acneiform rash or infusion reaction,~          allergic reaction or anaphylactoid reaction AEs in patients with irinotecan-refractory~          metastatic colorectal cancer following weekly or 2-weekly nimotuzumab schedules;~        -  To assess Progression-Free Survival (PFS), defined as time from date of randomization~          until date of disease progression (clinical or radiological) or death due to any cause,~          for the two nimotuzumab schedules;~        -  To assess the rates and durations of Stable Disease (SD) following weekly or 2-weekly~          nimotuzumab schedules;~        -  To assess the Time to Disease Progression (TTP) following weekly or 2-weekly nimotuzumab~          schedules;~        -  To evaluate ORR in patients who are identified as having primary irinotecan resistance~          following weekly or 2-weekly nimotuzumab schedules;~        -  To evaluate Overall Survival (OS) following weekly or 2-weekly nimotuzumab schedules;~        -  To compare the two dosing schedules of nimotuzumab with respect to objective response~          rates and safety;~        -  To evaluate the overall safety and toxicity profiles of these two dose regimens of~          nimotuzumab;~        -  To evaluate trough levels and accumulation of nimotuzumab in serum of patients receiving~          the drug on weekly or 2-weekly regimens.~   "
233941|NCT00493844|"~     The investigators' objective is to compare a new strategy combining clinical history and~     NT-proBNP levels versus the usual care, consisting of early exercise testing, for decision~     making in patients presenting to the emergency department with acute chest pain,~     non-diagnostic electrocardiogram and normal troponin. The investigators hypothesised that the~     new strategy combining clinical risk score and NT-proBNP will reduce the number of~     hospitalisations without increasing the number of events during the follow-up.~   "
233944|NCT00493805|"~     This is a Phase 3b/4, prospective, open-label, randomized, multicenter study of peginterferon~     alfa-2b plus ribavirin in participants with chronic hepatitis C, genotype 1. The study~     consists of two parts: (1) a noninterventional arm (HOMA IR <= 2) and (2) an interventional~     arm (HOMA IR > 2), where HOMA IR is the insulin resistance index for the participants~     calculated by fasting insulin (uU/mL) x [fasting glucose (mmol/L)/22.5]. Participants in the~     noninterventional arm are treated according to the European labeling and response rates are~     evaluated at Month 1 (optional), 3, 6, 12, and follow up. Participants in the interventional~     arm are treated with PEG-Intron 1.5 ug/kg (subcutaneous) once weekly plus weight-based~     REBETOL 800-1400 mg (oral capsules) daily for a variable period depending on their response~     at Week 12: (1) HCV-RNA positive with < 2-log drop in viral load, treatment will be~     discontinued; (2) HCV-RNA positive with >= 2-log drop in viral load; participants will be~     randomized (1:1) to Group A (stop treatment at Week 48) or Group B (stop treatment at Week~     72); and (3) HCV-RNA negative, treatment will be changed to be according to the European~     labeling and response rates will be evaluated at Month 6, 12, and follow up. All participants~     will go on with their treatment after Week 12 until the results of the HCV polymerase chain~     reaction (PCR) are available (maximum of 4 weeks).~   "
233945|NCT00493792|"~     A prospective, randomized, blinded clinical trial is proposed to compare Stryker Orthopaedics~     N2Vac Polyethylene to their X3 Polyethylene when used with the Triathlon Posterior Stabilized~     (PS) total knee system.~   "
233946|NCT00493779|"~     The purpose of the study is to look at the biomarkers of inflammation and platelet activation~     in patients with drug eluting stents implanted approximately 12 months ago on aspirin and~     statin, for a 4-week period after the routine discontinuation of clopidogrel~   "
233947|NCT00493766|"~     This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral~     formulation) alone and in combination with docetaxel in patients with progressing hormone~     refractory prostate cancer. This study is designed to determine the maximum tolerated dose of~     LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a~     day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic~     profile~   "
233948|NCT00493753|"~     The aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to~     people with systemic lupus erythematosus (SLE). Twenty-four SLE patients were assigned~     randomly to receive either 10 sessions of acupuncture, 10 sessions of a minimal-needling~     control intervention, or their usual medical care alone. It was hypothesized that acupuncture~     would be safe for people with SLE, and that participants would be able to complete their~     assigned treatment within 5 to 6 weeks.~   "
233949|NCT00493740|"~     The objective of this trial is to examine the cephalic phase insulin response (CPIR) and~     pancreatic polypeptide (PP) release as indicators of the cephalic phase occurrence and~     magnitude to palatable food stimulus (chocolate cake) in oncology patients before and after~     chemotherapy treatment as compared to healthy controls . This may enlighten our understanding~     of the etiology of taste dysfunction and anorexia during chemotherapy treatments.~   "
233950|NCT00493727|"~     The study will look at the effect of 30 days of treatment of 15 diabetics with proteinuria~     with N-acetylcysteine ( Mucomyst ) at a dose of 1 gm twice a day by mouth. The primary~     outcome that will be measured is change in the oxidant stress as measurable by changes in the~     serum level of isoprostane, Glutathione peroxidase, aconitase and Total oxidant stress.~     Secondary outcomes measured will be changes in proteinuria and kidney function as measured by~     spot urine pr/cr and estimated GFR by MDRD formula.~   "
233951|NCT00493714|"~     Primary Objectives:~        1. To determine the proportion of patients who experience partial or complete recollection~          of symptoms of delirium and the level of distress associated with this recall.~        2. To determine caregiver's level of distress associated with the patient's episode of~          delirium.~   "
233952|NCT00493701|"~     This study is designed to predict weight gain overtime after a high fat diet.~   "
233953|NCT00493688|"~     To validate a new method for assessing perioperative risk in the cancer patient undergoing~     major cancer surgery.~      In this proposed study researchers will:~        1. Measure preoperative energy reserve capacity (fitness)~        2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas~          exchange metabolism~   "
233954|NCT00493675|"~     Endoscopic sphincterotomy and temporary stenting is a routine treatment for post~     cholecystectomy cystic duct leakage. The draw back is that the plastic stent need to be~     removed later in a second intervention. Our studies with animal models have demonstrated that~     biodegradable biliary stent is at least as good as conventional plastic stent to heal that~     kind of leakage. In this pilot study the biodegradable biliary stent is inserted~     endoscopically to patients with confirmed cystic duct leakage to demonstrate the efficacy in~     human setting.~   "
233955|NCT00493662|"~     To evaluate the efficacy of two lubricating eye drops for the treatment of dry eye signs and~     symptoms.~   "
233956|NCT00493649|"~     The purpose of this research study is to find out what effects (good and bad)~     docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand~     name: Herceptin, or H) has HER2+ breast cancer.~   "
233957|NCT00493636|"~     The study is being conducted to compare progression-free survival in patients treated with~     sorafenib and gemcitabine/capecitabine versus patients treated with placebo and~     gemcitabine/capecitabine for locally advanced or metastatic breast cancer that has progressed~     during or following treatment with a bevacizumab-containing regimen.~   "
233958|NCT00493623|"~     This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with~     osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be~     randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated~     time on study treatment is <3 months, and the target sample size is 100-500 individuals.~   "
233959|NCT00493610|"~     The study will examine the effects of treatment with N-acetylcysteine ( Mucomyst ) 1 gm twice~     a day for 30 dyas in 15 patients with hepatitis C. The primary outcome of interest wil be the~     changes in oxidant stress as measured by different oxidant stress markers level in sera.~     Secondary outcomes of interest will be changes in viral load of hep C and changes in liver~     function~   "
234494|NCT00486551|"~     This is a clinical study of a cognitive-behavioral therapy known as anger control training in~     adolescents with Tourette Syndrome and explosive, disruptive behavior. ACT is compared to~     treatment as usual (TAU) in a randomized clinical trial.~   "
233960|NCT00493597|"~     clinically relevant in stent restenosis occurs in 5-10% of the non-diabetic patients treated~     with a coronary bare metal stent. Recent research has identified endothelial progenitor cells~     as well as dendritic cells as components of neointima. Numerical and functional evaluation of~     endothelial progenitor and dendritic cells at the time of coronary stent implantation is~     assessed and the relation with clinical and/or angiographic restenosis at 6 months post-stent~     implantation is evaluated.~   "
233961|NCT00493584|"~     The purpose of this study is:~      A) To determine whether patients with a certain type of heart attack (NSTEMI) can be reliably~     diagnosed in an ambulance using telemedicine. This is mandatory if NSTEMI patients in the~     future are to be treated with acute balloon angioplasty (primary PCI).~      B) To evaluate whether primary PCI compared with the current regimen of initial medical~     stabilization and sub-acute PCI results in reduction of infarct-size in NSTEMI-patients.~   "
233962|NCT00493571|"~     The goal of this clinical research study is to find the highest tolerable dose of gimatecan~     that can be given to treat myelodysplastic syndrome (MDS).~   "
233963|NCT00493558|"~     The purpose of this study is to gather information on the effectiveness of a new spine~     implant for patients who require spinal fusion surgery. Based on this information, we hope to~     create a standard of good performance, or benchmark, against which future studies on this~     spine implant can be compared. By creating this benchmark we hope to improve care for~     patients who require spinal fusion surgery.~   "
233964|NCT00493545|"~     The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC~     when given together~   "
233965|NCT00493532|"~     This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in~     women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3~     months. The anticipated time on study treatment is 3-12 months, and the target sample size is~     100 individuals.~   "
233966|NCT00493519|"~     The objective of this trial is to examine the cephalic phase insulin response (CPIR) and~     pancreatic polypeptide (PP) release as indicators of the cephalic phase occurrence and~     magnitude to palatable food stimulus in anorectic and bulimic subgroups as compared to~     healthy controls~   "
233967|NCT00493506|"~     The purpose of this study is to determine the safety and effects in HIV patients of~     supplementation (4-20 fl. oz. daily) with ProAlgaZyme, a novel fermentation product of a~     freshwater algae ecosystem, on markers of immune status, dyslipidemia, inflammation and~     oxidative stress alone or in combination with HAART (highly-active antiretroviral therapy).~   "
233968|NCT00493493|"~     Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective~     study that will evaluate the results of surgical pore excision, curettage, and injection of a~     regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease.~   "
233969|NCT00493480|"~     Patients with large esophageal varices who have not yet experienced bleeding, are normally~     treated with propranolol, a beta blocking agent that reduces the portal pressure and thereby~     diminish the risk of bleeding. 20-40% of the patients do not respond to this treatment or~     have to discontinue the treatment because of side effects. The aim of this study is to~     evaluate if carvedilol (a combined alfa -beta blocker) has better efficacy and safety than~     propranolol in lowering the portal pressure in patients with cirrhosis.~   "
233970|NCT00493467|"~     The goal of this clinical research study is to find out if giving (Rituxan) rituximab with~     90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma.~     The safety of this combination treatment will also be studied.~   "
233971|NCT00493454|"~     Primary Objective:~        -  Overall Response Rate (ORR).~      Secondary Objectives:~        -  The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients~          and in the responders.~        -  Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses~          (PR).~        -  Time to next anticancer therapy (TTNT).~   "
233972|NCT00493441|"~     The study was designed to find the optimum AVN944 dose to use in combination with gemcitabine~     in patients with pancreatic cancer and see if the combination of the 2 drugs was more~     effective for treating pancreatic cancer than using gemcitabine alone.~   "
233973|NCT00493428|"~     Recent studies indicate that liver cancer cells possess a receptor called the GABA-B receptor~     that when activated, inhibits the spread of cancer cells in test tubes. One of the drugs that~     activate these receptors is Baclofen, an agent that was originally developed to treat~     patients with various neurologic disorders. In this study, patients with recently identified~     liver cancer will be treated with Baclofen in an attempt to prevent or delay spread of the~     cancer beyond the liver. The time it takes for liver cancer to spread in the patients will be~     compared to the results obtained from patients enrolled in previous studies where Baclofen~     was not used.~   "
233974|NCT00493415|"~     The purpose of this study is to evaluate the effect of nitro-glycerine on the~     microcirculation (smallest vessel type) in patients with severe sepsis and septic shock.~      Nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. In~     this ICU the investigators use nitro-glycerine to improve the organ perfusion; but it's no~     common therapy in the rest of the world. The investigators now compare nitro-glycerine and~     placebo by looking to the sublingual microcirculation by a small camera (SDF imaging).~   "
233975|NCT00493402|"~     The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes~     (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with~     hepatocellular carcinoma (HCC).~   "
233976|NCT00493389|"~     Cortisol deficiency is diagnosed by the adrenocorticotrophin (ACTH) stimulation test. This~     test measures cortisol levels in the blood before and after giving an injection of ACTH.~     Currently, the results of this test can only be reliably interpreted when it is carried out~     on people in non-stressful situations. Frequently the test is carried out in hospitalized~     patients in stressful situations, giving results that are hard to interpret.~      Our study is to first do this test in a non-stressful situation, followed by a repeat test in~     a stressful situation, to compare the results and create a set of guidelines for interpreting~     the test when it is carried out in stressful situations.~   "
233977|NCT00493376|"~     The purpose of this study is as follows:~        -  to determine whether tirapazamine damages cervical tumour DNA immediately after its~          administration~        -  to determine the blood flow and oxygen level of cervical tumour before and after~          treatment with tirapazamine~   "
233978|NCT00493363|"~     There are worrying signs that parasitological responses to the artemisinin drugs for~     uncomplicated falciparum malaria are slower than elsewhere in the world.If responses to~     artesunate are poor it is essential to have characterised the blood concentration profile as~     well as the parasitological response to differentiate resistance from abnormal~     pharmacokinetics.~      The primary objective of the study is to assess the level of resistance to artemisinin~     derivatives in Western Cambodia.~      A detailed evaluation of 2 different artesunate containing regimens in patients with~     uncomplicated malaria will be performed. Patients will be randomised to receive either a)~     Artesunate 2mg/kg/day for 7 days or b) Artesunate 4mg/kg/day for 3 days plus mefloquine~     15mg/kg on day 3 and 10mg/kg on day 4 The effect on parasite clearance and cure will be~     assessed in relation to blood concentrations of the antimalarial drugs ('PK-PD').~   "
233979|NCT00493350|"~     Primary Objectives:~        1. To validate the prognostic significance of circulating tumor cells (CTCs) in patients~          with newly diagnosed metastatic breast cancer (MBC).~        2. To prospectively determine if assessment of CTCs can be used to stratify patients with~          MBC into two prognostic groups independent of existing methods i.e. hormone-receptor~          status, site of metastasis (e.g. visceral vs. non visceral) and treatment administered~          (e.g. chemotherapy vs. hormonal therapy).~        3. To incorporate this information into the current TNM staging system by sub-classifying~          stage IV disease into two prognostic groups, Stage IVA and Stage IVB.~      Secondary Objective:~      1. To perform global gene profiling on selected specimens and correlate the profiles with~     clinical outcomes.~   "
233980|NCT00493337|"~     The objective of the study is to test the effectiveness of a community pharmacist-led~     intervention to increase adherence to lipid lowering treatment.~   "
233981|NCT00493324|"~     A vaccine causes the immune system to produce antibodies (immune response) to specific germs~     to protect the patient. This study evaluates the immune response to the pneumococcal vaccine~     in adults with Alefacept-treated chronic plaque psoriasis.~   "
233982|NCT00493311|"~     A research study to determine if acetaminophen (APAP) given intravenously (IV-a liquid given~     through a needle into a vein in your arm) is safe and effective in controlling fever when~     compared to placebo. Acetaminophen given this way is the investigational part of this study.~   "
233983|NCT00493298|"~     The primary objective of this study is to assess the long-term safety and impact on disease~     activity and progression of natalizumab in participants with relapsing remitting multiple~     sclerosis (RRMS) in a clinical practice setting.~   "
233984|NCT00493285|"~     The overall objective of the MEDI-534 clinical development program is to evaluate the safety,~     efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in~     young infants.~   "
233985|NCT00493272|"~     The purpose of the present study is to perform a comprehensive description of haemostasis~     parameters before and after haemodilution with Hydroxyethyl starch (HES) following acute~     bleeding during elective surgery. Moreover the study aims to test the in vivo haemostatic~     potential of fibrinogen concentrate in dilutional coagulopathy caused by HES in a clinical,~     prospective, placebo-controlled randomised setup.~      We hypothesise; a) A coagulopathy is induced following in vivo haemodilution; b) the~     coagulopathy is improved or partially improved by fibrinogen.~   "
233986|NCT00493259|"~     The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for~     quality of life and altered health related issues.~   "
233987|NCT00493246|"~     We are doing this study to find out what happens to acetaminophen in the body after it is~     given to children through the vein. Children's bodies may handle drugs differently than~     adults. Understanding how long the drug stays in the body and how the drug is changed or~     metabolized by the body (called pharmacokinetics) is an important step in learning what the~     best dose of acetaminophen for children should be. We are also interested in learning about~     the safety of this medication when given to children.~   "
233988|NCT00493233|"~     The literature suggests that when a patient is prescribed more than one antipsychotic for at~     least 30 days, he or she is likely to continue on that combination. In this 12 week study 100~     adult patients being treated on more than one antipsychotic medication for at least 30 days~     will be recruited. In order to control for the natural course of the illness, patients will~     be randomly assigned to one of two groups: the first group will continue the second~     medication hidden in a capsule at the same dose, while the second group will be given an~     inactive capsule (placebo) - the capsules in both group will be identical such that neither~     the patient nor the treating doctor will be able to identify the group assignment.~   "
233989|NCT00493220|"~     The objectives of this study are:~        -  to establish the safety of subcutaneous administration of ceftriaxone at different~          concentrations, with and without HYLENEX recombinant, and to determine the maximum~          tolerated concentration;~        -  and to establish the pharmacokinetic comparability of subcutaneous administration of~          ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX~          recombinant and to IV administration.~   "
233990|NCT00493194|"~     This prospective, randomized study, comparing sirolimus to cyclosporine in renal transplant~     recipients, has two major objectives:~        1. -To determine the incidence and the degree of interstitialfibrosis and arteriosclerosis,~          as wel as the glomerular volume in protocol biopsies at 6 months in sirolimus-and in~          cyclosporine-treated renal allograft recipients, by means of quantitative computerized~          image analysis.~             -  To determine the prognostic implication of these morphologic changes.~        2. To study the expression of genes, involved in inflammation and fibrosis, in protocol~          biopsies at 6 months in sirolimus-and cyclosporine-treated renal allograft recipients.~   "
233991|NCT00493181|"~     The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the~     platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet~     counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine~     kinase inhibitors such as AMN107, dasatinib, or SK1606.~      Primary Objective:~      1. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in~     improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor~     therapy in patients with CML.~      Secondary Objective:~      1. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia~     associated with imatinib or other tyrosine kinase inhibitors~   "
233992|NCT00493168|"~     The first aim of this study is to determine how often unrecognized myocardial infarction~     occur in patients using a magnetic resonance imaging (MRI) technique (known as delayed~     enhancement MRI), as compared to the electrocardiogram. The second aim of this study is to~     determine the severity of coronary heart disease of the patients with unrecognized myocardial~     infarction. The final aim is to determine how the presence of unrecognized myocardial~     infarction detected by the MRI affects lifespan.~   "
233993|NCT00493155|"~     This study will determine the maximum tolerated dose, and assess the safety, tolerability and~     pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid~     tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be~     escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and~     tolerability of the previous dose, until the maximum tolerated dose is reached. The~     anticipated time on study treatment is until disease progression, and the target sample size~     is <100 individuals.~   "
233994|NCT00493142|"~     The purpose of this study is to determine whether a pre-operative home rehabilitation~     exercise program designed for knee replacements is more effective than pre-operative usual~     care.~   "
233995|NCT00493129|"~     Primary Objective:~      1. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients.~      Secondary Objectives:~        1. To assess the safety of ONTAK in SM patients.~        2. To evaluate the time to progression and duration of response following treatment with~          ONTAK.~   "
233996|NCT00493116|"~     This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a~     washout period in patients with Multiple Sclerosis who have previously developed neutralizing~     antibodies to Interferon-Beta~   "
233997|NCT00493103|"~     The aim of this study was to identify mutations in the thyroglobulin gene that might be~     present in patients with fetal goiter and congenital goiter hypothyroidism.~   "
233998|NCT00493090|"~     This study will address the key question of developing shared understanding and negotiating~     mutually acceptable outcomes between people with asthma and healthcare professionals by~     applying theoretical knowledge of self regulation and communication skills learning and~     practice to asthma consultations. This study will facilitate integration of best practice~     into normal care using the BTS/SIGN asthma guidelines as the basis for structured care. This~     intervention has been show to be effective in the US. We aim to show that it can be effective~     in the UK setting in a cluster randomised control trial. We aim to modify and evaluate the~     intervention in such a way that it can be easily offered across UK primary care settings,~     with the possibility of significant benefits for patients. The intervention is based on the~     principle of empowering patients to manage their condition themselves, is consistent with the~     aims of Asthma UK, and, for this reason, we believe that Asthma UK may wish to be associated~     with this project.~   "
233999|NCT00493077|"~     This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy~     in patients who have developed neutralizing antibodies during previous interferon-beta~     treatment~   "
234000|NCT00493064|"~     The purpose of this study is to determine whether Niacin, a B vitamin, may act as a~     vasodilator to encourage earlier formation of collateral blood vessels that may serve to~     bypass the obstructed vein in the eye. The topical steroid eye drops are aimed at reducing~     swelling in the retina, until the collateral vessels have a chance to develop.~   "
234001|NCT00493051|"~     This is a Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the safety~     and efficacy of one or two applications of topically applied GAM501 (Ad5PDGF-B/Bovine Type I~     Collagen Gel) in subjects ≥ 18 years old with non-healing diabetic foot ulcers. Approximately~     210 adult subjects with Type I or Type II diabetes mellitus will be enrolled at approximately~     30 investigational sites in the United States.~   "
234002|NCT00493038|"~     This is a clinical study organized to collect clinical data to better define the activity of~     some antimicrobials already marketed in Italy and in the rest of the world for the treatment~     of acute bacterial rhinosinusitis~   "
234003|NCT00493025|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these~     treatments before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed. Giving gefitinib after surgery may kill any tumor cells that remain~     after surgery.~      PURPOSE: This phase II trial is studying how well giving paclitaxel, cisplatin, gefitinib,~     and radiation therapy followed by surgery and gefitinib works in treating patients with~     locally advanced cancer of the esophagus or gastroesophageal junction that can be removed by~     surgery.~   "
234004|NCT00493012|"~     The purpose of the study is to investigate in overweight patients who are on a telemedically~     guided weight loss program the influence of a daily vitamin D supplement on~        -  weight loss and body composition,~        -  selected inflammation markers and biochemical parameters of lipid and glucose metabolism~          .~        -  selected clinical parameters such as blood pressure, heart rate~   "
234005|NCT00492999|"~     RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances~     directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     floxuridine and dexamethasone directly into the arteries around the tumor together with~     combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine~     and dexamethasone works when given together with combination chemotherapy in treating~     patients with colorectal cancer that has spread to the liver.~   "
234032|NCT00492648|"~     The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12~     post-vaccination in the primary study. In the extension studies presented here, the~     persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months~     after the first vaccination in young and elderly adults who received the GSK324332A vaccine.~     This protocol posting deals only with objectives & outcome measures of the extension phase at~     Months 30 and 42. No new recruitment will be done in these extension phases of the primary~     study. No vaccines are administered in this phase of the study.~   "
234006|NCT00492986|"~     Purpose of the study:~      The purpose of this study is to make sorafenib available for patients with advanced Renal~     Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring~     second line treatment), and who do not have access to or are not eligible for other clinical~     trials with sorafenib and who may benefit from treatment with sorafenib.~      Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a~     single agent. Patients may continue treatment until Disease Progression, intolerable~     toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any~     further from treatment.~      Overall, participation in the study will help determine the following:~        -  Find out if patients receiving Sorafenib will live longer~        -  Find out if Sorafenib helps to slow the worsening of kidney cancer~        -  Find out if Sorafenib has an effect on the tumours~   "
234007|NCT00492973|"~     Prior to surgery, a pharmacist will randomly assign participating patients to one of two~     groups. One group will get an injection in the knee during surgery that contains medications~     to limit pain and an antibiotic. A second group will get an injection in the knee during~     surgery that contains the same pain medications and antibiotic along with a corticosteroid to~     control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused~     with muscle-building anabolic steroids you may have heard about in the news. Each patient~     will have an equal chance of being in either of the two groups. This study will test the~     safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation~     following total knee replacement.~   "
234008|NCT00492960|"~     This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in~     preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects~     with celiac disease.~   "
234009|NCT00492947|"~     This research study is testing a new treatment of cancer of the head and neck.~      Purpose~      This research study is being done to:~        1. Test the safety of the experimental cancer vaccine made of dendritic cells. An~          experimental vaccine is one that is not approved by the Food and Drug Administration~          (FDA).~        2. To learn what effects (good and bad) the vaccine will have on you and your head and neck~          cancer.~        3. To learn if the vaccine will stimulate your body's white blood cells, which are part of~          your immune system (your body's natural defense system).~   "
234010|NCT00492934|"~     The study investigates if, among women with a regular cycle (between 25 and 45 days), the~     endometrium is better prepared for the transfer of an embryo that was cryopreserved and if~     the subsequent embryo implantation rate is higher when the cycle is started with daily,~     small-dose hormonal injections than in cycles without these daily injections.~   "
234011|NCT00492921|"~     RATIONALE: High-dose cyclophosphamide may be an effective treatment for acute~     graft-versus-host disease that did not respond to steroid therapy.~      PURPOSE: This phase II trial is studying the side effects, best dose, and how well high-dose~     cyclophosphamide works in treating patients with acute graft-versus-host disease that did not~     respond to steroid therapy.~   "
234012|NCT00492908|"~     A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath)~     With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary~     Intervention~   "
234013|NCT00492895|"~     Photosensitivity of the skin to UVA and UVB will be determined~   "
234014|NCT00492882|"~     We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of~     ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary~     Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this~     study, we plan to investigate whether a drop in the serum AMH level would be concomitant to~     the appearance of a dominant follicle induced by administration of mild amounts of exogenous~     FSH in women with PCOS.~   "
234015|NCT00492869|"~     Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and~     steroids in preventing acute rejection after kidney transplantation.~   "
234016|NCT00492856|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as gemtuzumab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Sometimes the cancer may not need more treatment until it~     progresses. In this case, observation may be sufficient. It is not yet known whether~     combination chemotherapy is more effective than observation when given as maintenance therapy~     in treating acute promyelocytic leukemia.~      PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and~     methotrexate to see how well they work when given as maintenance therapy compared with~     observation after combination chemotherapy in treating patients with acute promyelocytic~     leukemia. (Randomization and observation group closed as of 8/15/10)~   "
234017|NCT00492843|"~     The objective of this trial is to assess the efficacy and safety of loading doses versus~     standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone~     metastatic disease.~   "
234018|NCT00492830|"~     This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.~   "
234019|NCT00492817|"~     The goal of this clinical research study is to find out if stereotactic body radiotherapy to~     the spine using computerized tomography (CT)-on-Rails is safe and effective in the treatment~     of metastatic spine tumors.~      Objectives:~        -  Establish the safety and efficacy of using stereotactic body radiotherapy (SBRT) to~          treat spine and para-spinal tumors in a single session.~        -  Document frequency and severity of pain, symptoms and symptom interference, as well as~          quality of life before and after treatment.~        -  Document changes in neurological function at defined intervals compared to pre-treatment~          neurological function.~   "
234020|NCT00492804|"~     Chronic inguinal neuralgia is one of the most important complications following inguinal~     hernia repair.~      It may even outweigh the benefit of the operation. Intraoperative neurectomy has been~     investigated to reduce the incidence of chronic pain.~      This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric~     and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms~     after Lichtenstein hernia repair.~   "
234045|NCT00492479|"~     The purpose of this study is to compare the efficacy of the Kinerase Pro+Therapy regimen~     versus a single Kinerase product vs. control for the treatment of the signs of skin aging.~   "
234021|NCT00492791|"~     The endoscopic capsule is a new tool for exploration of the small intestine. The superiority~     of this technique on the radiological conventional examinations was shown in Crohn's disease.~     However no standardization of the lesions exists and no score of severity was proposed. The~     objective of this exploratory and multicentric study is to develop and validate an endoscopic~     score of severity especially dedicated to the examination by endoscopic capsule of the small~     intestine. Hundred twenty patients reached of disease of Crohn corresponding to various~     groups of severity will be included and will have an examination by video-capsule. The~     recorded examinations will be the standardized collection of all the lesions observed by~     independent readers, which will make it possible to evaluate the level of reproducibility of~     the detection of each lesion. Moreover, each reader will provide his total, qualitative and~     quantitative evaluations, of the severity of the attack of the small intestine. By using the~     data of only one reader, a score of severity will be built by simple linear function of the~     reproducible lesions observed. This score will be validated from the data corresponding to~     other readers of the same examinations, and those corresponding to another sample. Lastly,~     the aptitude of this score to detect the changes of the severity of the attack of the small~     intestine and to define the endoscopic cicatrization will be evaluated from data obtained~     among patients before and after treatment by infliximab or corticoids~   "
234022|NCT00492778|"~     This randomized phase II trial studies radiation therapy and cisplatin to see how well they~     work compared with radiation therapy alone in treating patients with endometrial cancer that~     has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. It is not yet known whether giving radiation therapy together~     with cisplatin is more effective than radiation therapy alone in treating patients with~     endometrial cancer.~   "
234023|NCT00492765|"~     This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a~     in patients with Multiple Sclerosis.~   "
234024|NCT00492752|"~     The purpose of the study is~        -  Find out if patients receiving Sorafenib will live longer~        -  Find out if Sorafenib has any effect on patient reported outcomes~        -  Find out if Sorafenib prevents the growth or shrinks liver tumors and / or their~          metastases~        -  Determine the pharmacokinetics (PK) in patients with liver cancer~   "
234025|NCT00492739|"~     Varicella is a vaccine-preventable disease, which can be severe in immunosuppressed children.~     Currently, the (live) vaccine is not recommended in pediatric orthotopic liver transplant~     recipients. Furthermore, protection due to naturally acquired immunity to VZV or~     post-immunization isn't well described in this population.The questions asked are:~        -  What is the influence of the immunosuppression required after orthotopic liver~          transplantation (OLT) on the maintenance of VZV-specific immunity elicited by wild-type~          varicella infection before OLT transplantation?~        -  What is the influence of the immunosuppression required after OLT on VZV-specific~          immunity elicited by varicella immunization before OLT transplantation?~        -  What is the influence of the residual immunosuppression at ≥ 12 months after OLT~          transplantation on the induction of VZV-specific B and T cell responses elicited by VZV~          vaccination after OLT transplantation?~        -  What is the influence of the residual immunosuppression at ≥ 12 months after OLT~          transplantation on the persistence / waning of B and T cell responses elicited by VZV~          vaccination?~   "
234026|NCT00492726|"~     A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with~     intra-abdominal infections.~   "
234027|NCT00492713|"~     Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised~     that the bioavailability of epicatechin from milk chocolate was reduced compared to dark. The~     primary outcome measure is to compare plasma polyphenol levels after consumption of 3~     chocolates (2 milk, 1 dark) while the secondary outcome measures are to characterise the time~     course of polyphenols in the blood and to investigate individual variation in Tmax and Cmax~     for use in future studies.~   "
234028|NCT00492700|"~     This study is intended to find out whether treatment with rosiglitazone improves the state of~     the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).~   "
234029|NCT00492687|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Tamoxifen may~     make tumor cells more sensitive to radiation therapy and chemotherapy. Giving radiation~     therapy together with temozolomide, tamoxifen, and carboplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving radiation~     therapy together with temozolomide, tamoxifen, and carboplatin works in treating patients~     with malignant gliomas.~   "
234030|NCT00492674|"~     Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee~     osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such~     procedure. Previous studies have shown that there is correlation between both pre-operative~     functional status and the intensiveness of the post-operative rehabilitation to the post~     operative function of the patient.~      An important part of the peri-operative rehabilitation in TKA is the neuromuscular control~     re-education.~      A novel biomechanical device comprising of four individually calibrated elements attached~     onto foot-worn platforms was recently developed. This device is capable of bringing the~     patient to a functional bio-mechanical alignment during standing and walking, while~     simultaneously strengthening dynamic stabilizers and training neuromuscular control by means~     of controlled biomechanical perturbations.~      Objectives: The aim of this study is to evaluate the influence of pre and post operative~     training with the biomechanical device mentioned above on the functional outcome and quality~     of life of patients undergoing TKA.~      Design and Setting: Randomized, controlled and double blind prospective trial~      Patients: 120 patients who are candidates to TKA~      Interventions: Patients will randomly assigned into five groups (active, sham and control)~     and will followed for fourteen months (two moths pre-operative and twelve months~     post-operative). All groups will undergo post-operative physical therapy (PT) according to~     the standard guidelines. In addition, the active groups will be treated with the device and~     its four biomechanical elements that had been individually calibrated for each patient. The~     sham group will be treated with the same device; however, the biomechanical elements will~     have zero perturbation and will be positioned along the central longitudinal line of the~     shoe-platform. The control group will be treated only according to the standard~     post-operative protocol.~      The five groups:~        1. Pre- operative BD training and post-operative PT and BD training~        2. Pre- operative sham training and post-operative PT and BD training~        3. Pre- operative sham training and post-operative PT and sham training~        4. No pre-operative training (according to the guidelines in Israel) and post-operative PT~          and BD training.~        5. No pre-operative training (according to the guidelines in Israel) and post-operative PT~          and sham training.~      Primary Outcome Measures: Spatio-temporal measures (recorded by Gait-Rite™) and the~     Aggregated Locomotor Function (ALF) assessment.~      Secondary Outcome Measures: Pain and function questionnaire measured by the Western Ontario~     and McMaster Osteoarthritis Index (WOMAC) and Quality of life will be evaluated by the SF-36~     quality of life questionnaire.~      Measurements will be taken at day-1 (two months before the TKA) and at four more stations: 1~     Week prior to the TKA, Three months post the TKA, six months post the TKA and twelve months~     post the TKA~   "
234033|NCT00492635|"~     A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed'~     (immediately before intended sexual activity) compared to placebo, to evaluate its~     tolerability and if it can help in recovery of erections after a nerve sparing radical~     prostatectomy.~   "
234034|NCT00492622|"~     The purpose of this study is to compare the blood drug levels of two prescribed medications,~     immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to~     determine which drug is better absorbed in patients with a slow stomach emptying~     (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug~     omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium~     bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a~     protective coating. Immediate-release omeprazole suspension may have a more rapid~     pharmacokinetic profile and greater overall drug absorption in gastroparesis.~   "
234035|NCT00492609|"~     A poor outcome in anterior cruciate ligament (ACL) reconstruction is often related to tunnel~     position. The researchers believe that improving the accuracy of tunnel position will lead to~     an improved outcome in ACL surgery. The researchers' purpose is to perform a controlled study~     on a series of 500 patients in two groups: group I (250 cases) using conventional~     instrumentation and group II (250 cases) using navigation (Surgetics ACL Julliard protocol).~   "
234036|NCT00492596|"~     Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the~     involuntary leakage of urine during routine physical activities such as laughing, coughing,~     exercising, or sneezing. SUI affects women of all ages and can result in significant~     emotional distress. The purpose of this study is to evaluate a non-surgical, investigational~     treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.~   "
234037|NCT00492583|"~     The purpose of this study is to determine if the consumption of a yogurt drink containing a~     high dose of probiotics decreases absences, due to illnesses, in daycare centers for children~     between the ages of 1 and 3.~   "
234038|NCT00492570|"~     This study is being done to increase awareness for early therapy with Avonex for Multiple~     Sclerosis (MS) and the cognitive dysfunction that accompanies MS, and to record safety data~     for Avonex.~   "
234039|NCT00492557|"~     The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to~     prevent pneumococcal diseases such as meningitis (inflammation of the brain lining),~     septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent~     influenza vaccine (TIV) is frequently given to adults, it is important to show that both~     vaccines can safely be given together without affecting the immune response (body's ability~     to protect against disease).~   "
234040|NCT00492544|"~     Human papillomavirus (HPV) infection has been established as a necessary cause of cervical~     cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common~     oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers.~     In previous trials, the vaccine has been found to be efficacious in the prevention of~     incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV~     vaccination should ideally be performed before onset of sexual activity. Previous studies~     showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to~     European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim~     to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy~     Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting~     has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
234041|NCT00492531|"~     This study will examine whether the drug sildenafil can lower blood pressure in the pulmonary~     artery (the blood vessel that leads from the heart to the lungs) in patients with sickle cell~     disease and pulmonary hypertension (high blood pressure in the lungs). It will see if this~     treatment can reduce disease complications, such as shortness of breath, pain crisis,~     pneumonia, and increase survival.~      Patients 12 years of age and older with sickle cell disease and pulmonary hypertension may be~     eligible for this study. Participants are randomly assigned to receive sildenafil or placebo~     (sugar pill) for 16 weeks. Before starting treatment, patients have baseline studies,~     including a pregnancy test for females of childbearing age; a chest x-ray; pulmonary function~     tests to measure how much air the patient can breathe in and out; an echocardiogram (heart~     ultrasound); a 6-minute walk test to measure exercise capacity; a quality-of-life assessment~     and a pain inventory. Patients with moderate to severe pulmonary hypertension undergo heart~     catheterization to evaluate the severity of hypertension before beginning sildenafil therapy.~      During treatment, patients are monitored with the following:~        -  Blood tests: weeks 6, 10 and 16.~        -  Echocardiogram: weeks 6 and 16.~        -  6-minute walk test: weeks 6, 10 and 16.~        -  Measurements of weight, blood pressure and heart rate: weeks 6, 10 and 16.~        -  Pregnancy test for women of childbearing age: weeks 6, 10 and 16.~        -  Pain questionnaire once a day for a week: weeks 6 and 1.0~        -  Quality-of-life questionnaire: week 16.~        -  Heart catheterization: week 16 for patients with moderate to severe hypertension.~      At the end of the 16-week period, patients may opt to continue to receive sildenafil and~     monitoring in an open-label phase of the study for up to 1 year.~   "
234042|NCT00492518|"~     Several studies demonstrated a significant reduction of contrast-induced nephropathy (CIN;~     definition: increase in serum creatinine of >=0.5mg/dl and/or >=25% increase within 48h after~     contrast-medium) by acetylcysteine (A) or theophylline (T). However, the results are~     contradictory. Therefore, it was the aim of our double-blind study to compare the effects of~     A, T, a combination of A and T (A+T), and placebo (P).~   "
234043|NCT00492505|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving sorafenib together with~     tamoxifen and cisplatin after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib~     together with tamoxifen and cisplatin works in treating patients with high-risk stage III~     melanoma.~   "
234044|NCT00492492|"~     Treatment of extension fractures of the distal radius : prospective randomized postoperative~     comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle~     plating on the other side.~   "
234048|NCT00492440|"~     RATIONALE: Interleukin-7 may stimulate the white blood cells to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in~     treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer.~   "
234049|NCT00492427|"~     This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of~     subcutaneous R744 in renal anemia patients on Predialysis.~   "
234050|NCT00492414|"~     Panic disorder(PD)is a disabling psychiatric condition associated with significant impairment~     in psychosocial, occupational functioning and quality of life, as mentioned by mogotsi et al.~     So, most patients with panic disorder suffers from the consequences of the impairment in~     occupational function. This impairment is not only individual problem, but also social one.~     Since productivity is very important item required to employees, lost productive time among~     workers with psychiatric illness should be reduced by the proper management. But few data~     were reported in this field by now.~   "
234051|NCT00492401|"~     This phase II trial is studying how well decitabine works in treating patients with~     previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing~   "
234052|NCT00492388|"~     To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the~     treatment of breakthrough pain in cancer patients.~   "
234053|NCT00492362|"~     Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to~     effects of pedometer use outside of hemodialysis on exercise capacity, functional status,~     quality of life and adequacy of hemodialysis.~   "
234054|NCT00492349|"~     The principal aim of the project is to conduct an off-label adjunctive clinical trial~     evaluating varenicline as a treatment for core neurobiological and clinical deficits in~     schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.~   "
234055|NCT00492336|"~     This is a study of a new medication for the treatment of cognitive impairments (thinking~     difficulties) and negative symptoms in people with schizophrenia. The new medication is~     rasagiline. Rasagiline is a drug which has been approved by the Food and Drug Administration~     for the treatment of Parkinson's disease. It is used to treat cognitive problems.~   "
234056|NCT00492323|"~     The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200~     mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic~     neuralgia.~   "
234057|NCT00492310|"~     The purpose of this study is to examine the feasibility, acceptability and initial~     effectiveness of adding yoga to a traditional, group-based treatment for smoking cessation~     for women smokers.~   "
234058|NCT00492297|"~     The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY~     43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC).~     DTIC is the current standard chemotherapy drug given for melanoma that has spread through the~     body. Although this drug can be effective on its own and is generally well tolerated, not all~     patients will benefit, so there is a need to test new drugs and drug combinations for~     treating melanoma.~   "
234059|NCT00492284|"~     The objective of this study is to determine if combination therapy (reduced-fluence Visudyne~     followed by Lucentis [within 2 hours] or either of two regimens of reduced-fluence Visudyne~     followed by Lucentis-Dexamethasone triple therapy [within 2 hours]) reduces retreatment rates~     compared with Lucentis monotherapy while maintaining similar vision outcomes and an~     acceptable safety profile.~   "
234060|NCT00492271|"~     The purpose of this study is to study the safety of single doses and multiple doses of~     Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the~     subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of~     subjects has activity against bacteria.~   "
234061|NCT00492258|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after~     surgery may kill any tumor cells that remain after surgery. It is not yet known whether~     sorafenib is more effective than a placebo in treating kidney cancer.~      PURPOSE: This randomized phase III trial is studying sorafenib to see how well it works~     compared with a placebo in treating patients at risk of relapse after undergoing surgery to~     remove kidney cancer.~   "
234062|NCT00492245|"~     The present study was designed to evaluate the treatment of adenoviral corneal opacities with~     PTK and mitomycin C.~   "
234063|NCT00492232|"~     The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the~     discontinuation of zolpidem in subjects with chronic insomnia.~   "
234064|NCT00492219|"~     The purpose of this study is to determine if patients with a fixed-bearing or mobile-bearing~     partial knee replacement perform functional activities differently than patients that have~     had total knee replacement or healthy volunteers that have not had knee surgery. The~     activities we are interested in include getting up out of a chair, stepping up and over a~     small wooden box, and standing still with the knees straight and also bent to 45 degrees.~   "
234065|NCT00492206|"~     This is an open label, phase II study in which cetuximab with concurrent thoracic~     radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab~     will be administered to subjects with locally advanced NSCLC.~   "
234066|NCT00492193|"~     The purpose of this trial is to gather information on the postoperative recovery time and~     hospital length of stay experienced by patients having laparoscopic surgeries. This trial~     will also collect data on daily surgical pain and pain medication and how it relates to~     recovery after surgery. In addition, the investigators will collect data on the use of pain~     medication and laxatives in patients following laparoscopic large bowel resection.~   "
234067|NCT00492167|"~     RATIONALE: Beta-glucan may stimulate the immune system and stop tumor cells from growing.~     Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Giving beta-glucan together with monoclonal antibody~     3F8 may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when~     given together with monoclonal antibody 3F8 in treating patients with metastatic~     neuroblastoma.~   "
234068|NCT00492154|"~     The fractures of distal forearm are the most common trauma in children. Sometimes one of the~     bones becomes shortened as a result of fracture fragments overlap. When some amount of~     shortening exists, concern regarding relationship of distal radio-ulnar joint (DRUJ) arises.~     The common opinion is expressed in one of the textbooks and is represented by one sentence,~     which usually one bone shortening is well tolerated, probably does not cause a problem, and~     does not have clinical significance. However, pathology of ulna plus or minus variants is~     well described and may cause ulno-carpal abutting syndrome or radiocarpal pain. This concern~     may lead to more aggressive approach in treatment of a fracture, with attempts to make an~     equal bone length. We did not find in the literature study that investigates this problem. We~     postulate that obvious shortening of one bone may cause an inequality of DRUJ and can be~     clinically significant.~   "
234069|NCT00492141|"~     Primary Objectives:~        1. To determine the feasibility and toxicity profile of administering liposomal~          9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with~          temozolomide.~        2. To determine the effectiveness of L9-NC given by aerosol in combination with~          temozolomide in patients with solid tumors involving the lungs.~   "
234070|NCT00492128|"~     The purpose of this study is to compare the effect and safety of the antihypertensive~     combination therapies between losartan/amlodipine and fixed dose drug of~     losartan/hydrochlorothiazide.~   "
234071|NCT00492115|"~     Patients with sleep disordered breathing (SDB), also called sleep apnea, experience nighttime~     disrupted sleep and, because they stop breathing for short periods during the night, do not~     get sufficient oxygen to their brains. This can frequently result in daytime impairments~     including difficulties with memory. The state-of-the-art treatment for SDB is Continuous~     Positive Airway Pressure (CPAP). Many non-demented SDB patients who are successfully treated~     with CPAP show improvement in memory and other cognitive functions. Data have shown that~     patients with Parkinson's disease have a high rate of SDB. Patients with Parkinson's disease~     also often have problems with memory. This study will test the effects of treating SDB among~     patients with Parkinson's disease and SDB. Specifically, the study will test the effect of~     CPAP treatment on SDB and sleep; the effect of CPAP treatment on daytime sleepiness,~     cognition, overall quality of life and mood; the effect of CPAP treatment on the frequency of~     symptoms of REM behavior disorder and restless legs syndrome; the effect of continued CPAP~     use (beyond the six weeks of the study) on SDB, sleep, cognition, mood and quality of life;~     whether the study-partner feels that CPAP improves the patient's sleep, mood and overall~     functioning; whether study-partners feel that their own sleep, mood and overall functioning~     improve as the patient's sleep improves both during the 6-week protocol and at follow-up for~     those opting to continue using CPAP.~   "
234072|NCT00492102|"~     The purpose of this study is to determine the pharmacokinetics (PK) of montelukast~     (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary~     dysplasia (the need for supplemental oxygen). The investigators' long-term hypothesis is that~     inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation,~     remodeling and the incidence of bronchopulmonary dysplasia (BPD).~   "
234073|NCT00492089|"~     Bevacizumab may reduce CNS side effects caused by radiation therapy. This randomized phase II~     trial is studying how well bevacizumab works in reducing CNS side effects in patients who~     have undergone radiation therapy to the brain for primary brain tumor, meningioma, or head~     and neck cancer.~   "
234074|NCT00492076|"~     The purpose of this study is to determine whether a short course of subcutaneous~     immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in~     control medication.~   "
234075|NCT00492063|"~     The present study aims to evaluate the safety and immunogenicity of the new influenza subunit~     vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly~     subjects.~   "
234076|NCT00492050|"~     The main goal of this clinical research study is to learn if Velcade ® (bortezomib) given~     with rituximab can help to control WM. This drug combination will allow researchers to~     collect your stem cells in case it is possible to transplant the stem cells as treatment if~     your WM gets worse. Researchers will also look at the safety and tolerability of this drug~     combination followed by treatment with other drug combinations.~   "
234077|NCT00492037|"~     Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic~     hyponatremia~   "
234078|NCT00492024|"~     The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day~     treatment of adult patients with acute bacterial sinusitis and to measure the amount of time~     it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of~     acute bacterial sinusitis, therefore in this study Avelox is considered an investigational~     drug. In this study Avelox will be compared to placebo.~   "
234079|NCT00492011|"~     The purpose of this study to determine the degree to which ramelteon, once daily (QD), can~     reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.~   "
234080|NCT00491998|"~     The purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar~     or better than existing medications for the treatment of Parkinson's Disease~   "
234081|NCT00491985|"~     This is an open, randomized, multicenter clinical trial.~      Objectives:~        -  To describe the safety profiles during the 21 days following each primary and booster~          injection.~        -  To describe the immune response 21 days after each primary and booster injection of each~          formulation.~        -  To describe the antibody persistence after the first vaccination~   "
234104|NCT00491673|"~     There is increasing evidence that primary hemiarthroplasty is the treatment of choice for~     displaced femoral neck fractures in the elderly~      No definite conclusions have been made in regards to what kind of arthroplasty is favourable~      Cemented implants are associated with increased risk of perioperative cardiovascular~     incidents and increased mortality.~      Cementless implants are associated with increased postoperative pain and decreased walking~     ability.~      This study investigates the differences between one well-documented cemented femoral stem and~     one well-documented uncemented femoral stem. Previous studies have mostly used uncemented~     stems with different designs.~      Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5~     years~   "
234495|NCT00486538|"~     This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the~     treatment of subjects with advanced renal cell carcinoma who have previously received~     treatment with sunitinib.~   "
234082|NCT00491959|"~     Since cultivated autologous oral mucosal epithelial sheets on amniotic membrane have been~     reported to have good clinical results in treating patients with ocular surface disorders in~     both human or animal studies, and such technique has not been used in our hospital, the main~     purpose of this study is to use these cell sheets to treat patients with severe surface~     disorders, which include limbal insufficiency induced corneal surface problem, and~     symblepharon caused by severe conjunctival epithelial insufficiency. We will first choose~     patients who meet the surgical criteria, and these patients need to receive dental~     examination three months before surgery. Two weeks before transplantation, the oral mucosa~     tissue will be obtained by a dentist and the oral mucosal epithelial cell sheets will be~     cultivated on amniotic membrane until reaching confluency and stratification. During the~     transplantation surgery, the abnormal fibrovascular tissues on the ocular surface will be~     removed. The areas of symblepharon will also be released. The cultivated oral mucosal cell~     sheets will be transplanted on the denuded corneal surface or the scleral surface of the~     symblepharon area. Therapeutic contact lenses will be applied after surgery. After operation,~     the patients will be admitted for about two weeks. After discharge, the patients need to~     receive regular follow up weekly during the first two months, followed by biweekly follow up~     until postoperative 6 months. Afterward, the patients need to receive monthly follow up until~     postoperative 2 years. During the follow up, the data of the patients' visual acuity,~     intraocular pressure, slit lamp biomicroscopic findings, and in vivo confocal microscopic~     data will be obtained. The project plans to start from July 1st 2007 until June 30th 2010. We~     plan to enroll totally 20 patients.~   "
234083|NCT00491946|"~     To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in~     children with cancer.~   "
234084|NCT00491933|"~     The purpose of this study is to evaluate the value of Quantiferon-TB Gold (QFT-G) assay in~     the screening for latent tuberculosis infection (LTBI) in rheumatologic patients due to start~     or on treatment with TNFα antagonists. The results of QFT-G will be compared to tuberculin~     skin testing (TST) and correlated to clinical and demographic data. The study hypothesis is~     that the inclusion of QTF-G in the screening strategy will allow a more accurate assessment~     of LTBI infection.~   "
234085|NCT00491920|"~     Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What~     dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis~     that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a~     randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women~     with T-score <= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and~     vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week,~     while the other half will have placebo. The study period is one year.~   "
234086|NCT00491907|"~     The randomized, double-blind, placebo-controlled study aim to evaluate the effect of 1-month~     therapy with folic acid (5 mg/day) on endothelial function and baroreceptor function in~     patients with heart failure.~      Endothelial function will be studied non-invasively with flow-mediated dilation while for~     eveluating baroreceptor function sympathetic nervous system activity will be measured~     directly with microneurography in baseline condition and during infusion of~     sodium-nitroprusside.~   "
234087|NCT00491894|"~     This is an open-label clinical research study of an oral glycopyrrolate liquid for the~     treatment of chronic moderate to severe drooling in patients with cerebral palsy or other~     neurological conditions. Patients participating in the study will receive oral glycopyrrolate~     liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout,~     screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration~     period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration~     Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02~     mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal~     individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is~     reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is~     lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum~     benefit from the study drug (greatest improvement in drooling) while experiencing minimum~     side effects. All patients will receive close attention by study staff throughout the study.~   "
234088|NCT00491881|"~     There is much evidence that a reduction in dietary salt intake lowers blood pressure in~     hypertensive individuals, however few have looked at effect of 'no added salt diet' and~     modest salt intake on total restriction of sodium intake with especial attention to very~     exact surrogate of urinary sodium excretion. Our study demonstrates that a modest reduction~     in salt intake from regular level of 10 - 12 g per day to the recommended level of 5 - 6 g~     per day lowers blood pressure by 12.1/ 6.8 mmHg at day time and 11.1/5.9 mmhg at night~     time.However only 35% of patients reach to the goal of sodium restriction of diet(below 100~     meq/dl in 24 hours urine.It means even modest salt restriction can dramatically decrease~     blood pressure with no added salt diet.~   "
234089|NCT00491868|"~     This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of~     intravenous injections of R744 in renal anemia patients on Hemodialysis patients.~   "
234090|NCT00491855|"~     The goal of this clinical research is to learn acceptable dosages of paclitaxel, oxaliplatin,~     and Avastin (bevacizumab) that can be given in combination to patients with advanced~     peritoneal carcinomatosis. The safety of this drug combination will also be studied.~   "
234112|NCT00491569|"~     Both GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial~     for chronic schizophrenia patients.~      The purpose of this study is to compare efficacy and safety of add-on treatment of sarcosine,~     a GlyT-1 inhibitor, and D-serine, an NMDA-glycine site agonist, in chronically stable~     schizophrenia patients who have been stabilized with antipsychotics.~   "
234113|NCT00491556|"~     This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then~     de-intensification management strategy in adolescents with mild immunosuppression and compare~     changes in CD4% from baseline to week 48 and then during de-intensification.~   "
234277|NCT00489411|"~     RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet~     known whether duloxetine is more effective than a placebo in treating peripheral neuropathy~     caused by chemotherapy.~      PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works~     compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients~     with cancer.~   "
234091|NCT00491842|"~     This study will examine the ways in which people reveal their status as a carrier of~     Huntington s disease (HD) or of being at risk for the disease. It will explore factors that~     influence decisions about disclosure and how disclosure is made to family members, partners,~     and close friends.~      HD is an inherited, progressive disease. It causes nerve degeneration, motor disturbance,~     loss of awareness, and psychiatric symptoms. Currently, no effective treatment is available~     to prevent or delay HD progression. The mean age of onset is 35 to 44 years, and the median~     survival rate after onset is 15 to 18 years. HD affects about 1 in 10,000 people in the~     United States, so about 30,000 have HD and more than 200,000 are at risk. Predictive testing~     for HD has been available since 1993. It can be a life-changing event to learn of being at~     risk for HD. Disclosure has been studied among people with HD and other diseases, but~     knowledge about the extent of nondisclosure and disclosure is limited. There is evidence that~     a person s psychological adaptation to AD may be a factor. Adaptation involves processes that~     help a person search for meaning in what has happened, attempt to gain control of his or her~     life, and improve self-esteem in light of the threatening situation.~      Participants ages 18 and older who have had a positive genetic test result more than 6 months~     earlier regarding HD or who have a family history of HD but no predictive testing and who do~     not have symptoms of HD may be eligible for this study. Recruitment is done through HD~     clinics, support groups, and online websites and mailing listservs. About 260 people will be~     in the study. Participants will complete a survey taking 30 to 40 minutes to do. Two survey~     versions are available: for those who are gene carriers and for those at risk. Participants~     are asked to complete the version applying to them. The survey can be done online or through~     a hard copy to complete at home and send to NIH. This survey is anonymous.~      Participants will list the adults with whom they have a relationship and up to 10 people they~     interact with. They will indicate those who know about the HD gene or risk status. They will~     also list those to whom they have personally made disclosure. The goal is to distinguish if~     knowing the status or the act of disclosure is more important. Questions also involve~     discussing the inheritance and features of HD, and participants feelings or concerns about HD~     gene or risk status. Participants will be asked about their first disclosure experience, most~     recent experience of it, and timing of disclosure the time between learning of HD status and~     telling another person about it. There are also questions on decisions of nondisclosure,~     negative and positive aspects of disclosure for participants, and what health care~     professionals can do to help participants disclosure decisions.~   "
234092|NCT00491829|"~     To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month~     treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.~      To evaluate safety and tolerability of flibanserin in such patients.~   "
234093|NCT00491816|"~     Primary Study Objective:~      To assess the pathological complete response rate (pCR) with 4-6 cycles of neoadjuvant~     chemotherapy plus erlotinib in patients with triple negative breast cancer.~   "
234094|NCT00491803|"~     Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of~     pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric~     oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries~     of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary~     disease (COPD), we hypothesized that sildenafil might improve pulmonary hemodynamics and~     increase exercise tolerance in this condition. However, in COPD sildenafil may also impair~     gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research~     project is aimed to evaluate these effects.~      It is a prospective, randomized, double-blind study to evaluate the acute effects of a single~     dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20~     patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and~     ventilation-perfusion distributions; at rest and during sub-maximal exercise.~   "
234095|NCT00491790|"~     The purpose of this study is to determine if montelukast, in addition to standard treatment~     is helpful in treating patients ages 2-5 who are in the hospital because of status~     asthmaticus.~   "
234096|NCT00491777|"~     The new NcIQ thoracic impedance monitor is based on the predicate device, the IQ101. The new~     model uses the same 3-dimensional signal averaging as the original device, but also include~     second radio frequency signal to permit the device to work “wirelessly”, i.e., without~     electrode lead attachments to the patient. This study seeks to 1) validate the use of the new~     device and confirm the correlation of the IQ101 and NcIQ. 2) Evaluate the ease of the new~     device.~      The new IQ2 thoracic impedance monitor is based on the predicate device, the IQ101. The new~     model uses the same 3-dimensional signal averaging as the original device, but with smaller~     housing and updated operating software. This study seeks to 1) Validate the use of the new~     device and confirm the correlation of the IQ101 and IQ2. 2) Compare the ease of the devices.~   "
234097|NCT00491764|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral~     administration of four dosing regimens of posaconazole relative to placebo and terbinafine,~     in the treatment of toenail onychomycosis.~   "
234098|NCT00491751|"~     This study will seek to determine whether non-invasive measures of endothelial function have~     utility as surrogate markers of cardiovascular risk in patients with peripheral arterial~     disease undergoing vascular surgery. Measurements of endothelial function will be made before~     and after initiation of atorvastatin, ascorbic acid, or placebo therapy during the~     pre-operative period. We will then examine cardiovascular events following surgery. We~     hypothesize that patients who have no improvement in endothelial function will have increased~     cardiovascular risk compared to patients with improvement in endothelial function.~   "
234099|NCT00491738|"~     This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to~     evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo~     with sunitinib in patients with metastatic RCC who have not received prior systemic therapy~     for metastatic disease. The study will enroll approximately 100 patients at approximately 20~     centers in the United States.~   "
234100|NCT00491725|"~     This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety~     of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes~     inadequately controlled with OAD (oral anti-diabetic drugs).~   "
234101|NCT00491712|"~     The management of neovascular glaucoma (NVG) is a challenge for the ophthalmologist and~     surgery is frequently needed to control IOP. The success rates of a drainage device is~     usually lower in NVG than in other forms of glaucoma. Triamcinolone intra-vitreous injections~     acetate has been used to treat macular edema secondary to diabetic retinopathy and central~     retinal vein occlusion and also to control inflammation in ophthalmologic surgeries.~      In the present study we will compare the outcome and complications of Silicone Ahmed Valve in~     GNV eyes with and without intra-vitreous triamcinolone injection.~   "
234102|NCT00491699|"~     The purpose of this study is to determine the safest dose of XL999 and how well subjects with~     Non-Small-Cell Lung Cancer tolerate XL999. XL999 is a small molecule inhibitor of multiple~     kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell~     growth, formation of new blood vessels (angiogenesis), and metastasis.~   "
234103|NCT00491686|"~     The purpose of this study is to determine whether treatment with AZD6765 will have an~     antidepressant effect with patients who have treatment resistant depression.~   "
234105|NCT00491660|"~     Ventilator-associated pneumonia (VAP) is the leading cause of death among all nosocomial~     infections in ventilated patients. Once intubated, the risk of pneumonia in hospitalized~     patients is increased 3-10 fold; almost 90% of hospital-acquired pneumonia occurs in~     intubated patients. Each episode of VAP is associated with 7-9 days of additional hospital~     stay with an estimated increase in cost of care that exceeds $40,000. In an effort to control~     VAP, several studies were conducted including oral and gastric decontamination with~     antibiotics, rotation of the bed, and local instillation of antibiotics via endotracheal~     tube. Despite such efforts, VAP is still a major complication for intubated patients.~      The effect of gravity on bacterial colonization of the endotracheal tube was recently~     explored in an animal study that was conducted at the United States National Institutes of~     Health. The study demonstrated a significantly lower tracheal colonization and decreased~     alveolar contamination in ventilated sheep when positioned on their side allowing for~     tracheal drainage by gravity. Such findings have not been validated in clinical practice and~     the need for clinical trials studying the effect of lateral positioning have been demanded.~     Therefore, we aimed our randomized controlled trial to test the hypothesis that intubated~     infants who are positioned on their side are at lower risk for contracting microbes in their~     trachea when compared to those in a supine position.~   "
234106|NCT00491647|"~     Background: Literature has documented that children with attention-deficit/ hyperactivity~     disorder (ADHD) have difficulties in time management by manifesting with difficulties making~     plans, organizing tasks and activities, and awaiting their turns. However, the studies~     regarding time perception have been few as compared to those of neuropsychological measures~     and there is no information about this topic in Chinese population. In view of this, we will~     conduct a study to investigate the clinical and treatment aspects of time perception among~     children and adolescent with ADHD.~      Specific Aims:~        1. to examine the developmental and gender effect on the performance in time perception;~        2. to explore the deficit in time estimation, time discrimination, and time reproduction in~          children and adolescents with ADHD as compared to normal controls;~        3. to identify the association between ADHD symptoms and performance in time perception~          tasks; and~        4. to investigate the efficacy of MPH on the time perception measures among children and~          adolescents with ADHD; Subjects and Methods: This protocol consists of two studies.~          First, we will recruit 100 patients with DSM-IV ADHD, aged 9 to 16 years, and 100 school~          controls. They and their parents will receive K-SADS-E interviews. All of them will have~          complete assessments of time estimation, time discrimination, and time reproduction.~          Their parents also report on SNAP-IV and CPRS-R:S. The 2nd assessments will be performed~          3 months later after the subjects received treatment at outpatients.~      Anticipated Results: We anticipated that the ADHD group will have poorer time perception,~     particularly in difficult tasks, and the impairment will be reduced after treatment with~     medication~   "
234107|NCT00491634|"~     The study hypotheses is that the introduction of dose escalated treosulfan, in substitution~     to busulfan, will reduce toxicity after allogeneic transplantation while improving~     myeloablation and and disease control in patients with AML and MDS not eligible for standard~     transplantation.~   "
234108|NCT00491621|"~     Renal cancer is frequent and its diagnosis mainly dependant on imaging. More than 50% of~     renal tumors are currently diagnosed without symptoms. However, 20% of small solid tumors are~     benign and this percentage is much higher in atypical cystic tumors Bosniak II and III, where~     76% and 59% are benign respectively. Determining the malignancy by imaging in these cases is~     difficult and sometimes impossible. The fine needle aspiration (FNA) cytology or biopsy is~     necessary. The diagnostic sensitivity and specificity with biopsy are high, but the potential~     tumor contamination is a major risk. The FNA cytology is simple and safe, but its sensitivity~     is about 50%. We are conducting a multicentric prospective study to add the molecular markers~     in FNA cytology as a new diagnostic method in imaging-indeterminate renal tumors.~      Four molecular markers including MN/CA9, vimentin, KIT, and S100A1 will be studied. These~     four markers have been reported to have a differential diagnostic value in renal tumors.~     MN/CA9 and vimentin are often found in conventional renal cancers. KIT is frequently~     expressed in renal oncocytomas and chromophobe renal cancers. S100A1 may further distinguish~     renal oncocytoma from chromophobe renal cancer. These markers will be analyzed by real time~     polymerase chain reaction (RT-PCR).~      The aim of this study is to evaluate the diagnostic performance of the association~     cytology-molecular markers in imaging-indeterminate renal tumors (small solid tumors and~     cystic tumors ≥ Bosniak III). About 156 patients will be included in five French clinical~     centers including Saint-Etienne, Marseille, Grenoble, Toulouse, and Nancy.~      The expected results will improve the preoperative diagnostic accuracy in renal tumors.~   "
234109|NCT00491608|"~     The purpose of this study is to evaluate the safety and immune system response to recombinant~     thrombin when used to control bleeding in spinal and vascular surgery.~   "
234110|NCT00491595|"~     The purpose of this research study is to examine the safety of specific soy components, known~     as isoflavones, and to find out what effects (good and bad) these components have on tissues~     that are sensitive to the hormone estrogen in healthy, post-menopausal women. Isoflavones are~     compounds that occur naturally in soybeans and can be extracted to put in to capsule form or~     add to foods. The capsule formulation being used in this study is considered an~     investigational drug. This research is being done because many scientists believe that~     isoflavones may play a role in the prevention of some kinds of cancer. While isoflavones have~     been safely consumed in foods for centuries, we need to know if these soy components are safe~     to take in higher doses when they are extracted from foods and provided in a supplement form.~     We plan to test the safety and effects of the soy isoflavones known as genistein, daidzein~     and glycitein.~   "
234111|NCT00491582|"~     This study aims at investigating the effect of growth hormone on lipid-content of muscle and~     liver as well as visceral fat mass in relation to insulin sensitivity.~      In addition, hormonal regulation and free fatty availability is assessed during a physical~     exercise at 50-60% VO2max.~      Finally, the value of physical exercise in diagnosing growth hormone deficiency is~     investigated.~      Hypothesis: 1) Lipid content of muscle and liver change with physical exercise and exercise~     capacity and free fatty availability will influence these changes. 2)Growth hormone~     replacement therapy will predominantly reduce visceral fat mass and increase free fatty~     availability.~      3)Free fatty availability during exercise will be reduced in growth hormone deficient~     patients 4)Physical exercise may be an alternative way to diagnose growth hormone deficiency~   "
234114|NCT00491543|"~     ALT-2074 (BXT-51072) belongs to a class of drugs called glutathione peroxidase mimics.~     ALT-2074 works by imitating a substance produced in various tissues in the body, which~     prevents damage of the heart and blood vessels. Diabetic patients with a haptoglobin 2-2~     genotype have poor cardiovascular clinical outcomes.~      The purpose of this study is to assess the safety, the pharmacokinetic profile and~     characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of~     ALT 2074. Subjects must be diabetic, with evidence of coronary artery disease and a~     haptoglobin 2-2 genotype~   "
234115|NCT00491530|"~     The objective of the study is to assess the continued safety of the daily coadministration of~     ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.~   "
234116|NCT00491517|"~     Autosomal-Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal~     disease, characterized by the progressive development of fluid-filled cysts in the kidney~     leading to progressive loss of renal function and eventually to renal failure. It is~     responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western~     countries. ADPKD progression is largely dependent on the development and growth of the cysts~     and secondary disruption of the normal tissue. Renoprotective interventions in ADPKD - in~     addition to achieve maximal reduction of arterial blood pressure and proteinuria and to limit~     the effects of additional potential promoters of disease progression such as dyslipidemia,~     chronic hyperglycemia or smoking - should also be specifically aimed to correct the~     dysregulation of epithelial cell growth, secretion, and matrix interactions characteristic of~     the disease. Genetically in the ADPKD three different genes are implicated (PKD1 85% of the~     cases, PKD2 15% and probably PDK3 not yet identified). PKD1 gene encodes a protein named~     polycystin-1 (PC1). Defect in PC1 lead to aberrant activation of the enzyme mTOR in the~     epithelial cells of the renal tubules which eventually leads to abnormal proliferation of~     these cells and cysts generation.~      Sirolimus (Rapamycin) is an immunosuppressant mostly used for the management of kidney~     transplant recipients. This drug by very specifically and effectively inhibiting mTOR, exerts~     antiproliferative and growth inhibiting effects and could be extremely important for the~     inhibition of cyst progression in ADPKD. Animal models of ADPKD have shown that short-term~     treatment with sirolimus resulted in dramatic reduction of kidney size, prevented the loss of~     kidney function, and lowered cyst volume density. Similarly, retrospective observations from~     kidney transplant recipients have documented that sirolimus treatment reduced kidney volumes~     by 25%, whereas there was no effect in patients not given the drug.~      Overall, these findings provide the basis for designing a prospective study in ADPKD patients~     aimed to document the efficacy of sirolimus treatment in preventing further increase or even~     reducing the total kidney volume and the renal volume taken up by small cysts, eventually~     halting kidney disease progression. It is a 6 month treatment with sirolimus compared to~     conventional therapy in adult patients with ADPKD and normal renal function or mild to~     moderate renal insufficiency.~   "
234117|NCT00491504|"~     The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works~     to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting.~     Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will~     evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how~     long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses,~     3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's~     opinion of the study drugs by asking different questions. This study is could last up to 53~     days for some subjects.~   "
234118|NCT00491491|"~     The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning~     regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation~     in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall~     and disease-free survival.~   "
234119|NCT00491478|"~     Repetitive behavior disorders are prevalent among people with severe mental retardation.~     These disorders can interfere significantly with an individual’s daily functions. This trial~     is part of a long-term project that has studied the biologic basis of and possible treatments~     for repetitive behavior disorders. The trial will evaluate the effectiveness of two~     medications, a selective serotonin reuptake inhibitor (SSRI) and an atypical antipsychotic,~     in treating repetitive behavior disorders in people with mental retardation.~   "
234120|NCT00491465|"~     Randomized, controlled, open, comparative intervention study in two groups, each consisting~     of 25 children with type 1 diabetes that will undergo twelve weeks of exercise program~     (intensive arm) and twelve weeks of regular activity (non intensive arm) separated by four~     week of washout period. The study will be conducted in a crossover manner: one group starting~     with the intensive arm followed by the non intensive arm and vice versa. Blood glucose,~     HbA1C, Fructosamine, 3 days continuous glucose monitoring system (CGMS), total daily insulin~     dose, fasting lipid profile, body impedance and BMR will be measured. Self esteem and quality~     of life questionnaires will be filled.~   "
234121|NCT00491452|"~     Mitral valve repair for ischemic mitral regurgitation is performed primarily by annuloplasty.~     There is some degree of late failure, which may be due in part to the type of ring employed.~     We want to compare late results with mitral valve annuloplasty using flexible vs rigid~     annuloplasty rings.~   "
234122|NCT00491439|"~     Although epi-keratome laser-assisted in situ keratomileusis (Epi-LASIK), penetrating~     keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic~     retinopathy are surgeries commonly performed, the time-sequential, in vivo microscopic wound~     healing process is not fully understood. The purpose of this study is to study the healing of~     corneal wounds after Epi-LASIK, penetrating keratoplasty and pars plana vitrectomy with~     corneal epithelial debridement for diabetic retinopathy by in vivo confocal microscopy, an~     easily performed and non-invasive procedure. We plan to enroll 40 eyes of 40 patients in each~     of these three surgeries. In Epi-LASIK, slit-lamp biomicroscopy, in vivo confocal microscopy,~     and visual acuity are recorded before and 1, 3, and 7 days after surgery. The eyes are~     examined weekly in the first month and at 3 and 6 months. For penetrating keratoplasty and~     pars plana vitrectomy with corneal epithelial debridement, slit-lamp biomicroscopy, in vivo~     confocal microscopy, and visual acuity are recorded before and weekly in the first month~     after surgeries and at 3 and 6 months. Selected images of the corneal basal/apical surface~     epithelia, stromal reactions and corneal endothelial conditions by in vivo confocal~     microscopy are evaluated qualitatively for the cellular morphology and density.~   "
234123|NCT00491426|"~     The purpose of this protocol is to provide a mechanism for the ongoing collection of blood~     and urine samples in newborns that will be used to measure levels of antimicrobial products~     used in the newborn population where there are limited pharmacokinetic data in either~     premature or term infants.~   "
234124|NCT00491413|"~     Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells~     from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in~     infants who did not get enough oxygen during birth.~   "
234125|NCT00491400|"~     The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial~     function in patients with diabetes mellitus or the metabolic syndrome.~   "
234126|NCT00491387|"~     This is a study of patients with high blood pressure who are already treated with an~     angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair~     blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor~     blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic~     nervous system, thereby further improving left ventricular filling and blood pressure~     control.~   "
234127|NCT00491374|"~     This study will hope to show that the treatment of the patient's perennial allergic rhinitis~     (PAR) using Nasonex® (mometasone furoate nasal spray) will result in improvement of the nasal~     symptoms of PAR and of nighttime sleep-disordered breathing, thereby resulting in improved~     sleep quality, less daytime sleepiness, improved daytime functioning, and improved quality of~     life.~   "
234128|NCT00491361|"~     Background: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common childhood-onset~     neuropsychiatric disorder (7.5% in Taiwan) with great impact on individual, family, and~     society. The diagnosis of ADHD is mainly based on clinical interview of parents and children~     with assistance of teachers' reports. Self-administered rating scales are useful for~     screening, assistance of diagnosis, and measurement of symptom changes over time or due to~     treatment effect. The goals of this study are to establish the norms and psychometric~     properties of the Chinese version of teacher and parent forms of the Swanson, Nolan, and~     Pelham, version IV (SNAP-IV) and the teacher, parent, and student forms of the Strengths and~     Difficulties Questionnaire (SDQ) for future studies on ADHD in Taiwanese populations.~      Subjects and Methods: This is a cross-sectional, school-based survey with a multi-stage~     sampling method. The participants include a school-based sample of 3534 first to eighth~     graders was recruited from four areas: Taipei City, Taoyuan County, Tainan City and Chiayi~     County. Among them, 200students will be reassessed at 2-week interval for the test-retest~     reliability study. The instruments comprise the Chinese version of Child Behavioral Checklist~     (CBCL), SDQ, SNAP-IV, and Adult ADHD Rating Scale. The informants include student~     participants older than 10 years old, their parents, and teachers. The main statistical~     methods include Pearson correlation, intraclass correlation, Chronbach's α for internal~     consistency, and mixed model to address lack of independence within the same classes and~     schools.~      Anticipated Goals: We expect that this study will reach the following objectives:~        1. to obtain the primitive information about the prevalence of ADHD symptoms and~          emotional/behavioral problems among children and adolescents in Taipei and Yun-Ling;~        2. to enhance the awareness of school teachers and counselors about ADHD and other~          behavioral/emotional problems among students;~        3. to establish psychometric properties of the Chinese versions of SNAP-IV and SDQ for~          future use in clinical, school, and research settings.~   "
234129|NCT00491348|"~     (1) to compare the differences of neural activation of pathological worry between~     pre-treatment GAD patients and normal subjects; (2) to measure the differences of brain~     activation on worry in GAD patients before and after duloxetine treatment~   "
234130|NCT00491335|"~     Background:~      The incidence of lung cancer is quite high among people with the human immunodeficiency (HIV)~     virus. Frequent smoking may explain that cancer increase, given that 50% to 70% of~     HIV-infected people are current smokers.~      Recent research suggests that other factors may be involved as well. Smoking habits, such as~     smoking earlier in life or smoking more cigarettes a day than others do, may have a role.~     Also, HIV-infected smokers seem to have a greater risk of chronic obstructive pulmonary~     disease (COPD). The association of HIV and COPD is important, because COPD itself is linked~     to an increased risk of lung cancer.~      About 1,600 subjects from the study known as ALIVE (AIDS Linked to the Intra-Venous~     Experience), which began in 1988 in Baltimore, Maryland, will be given a detailed~     questionnaire on smoking behaviors and lung cancer risk factors. They will also have~     spirometry testing, to evaluate lung function.~      Objectives:~      To better characterize smoking habits and compare tobacco use among HIV-infected and~     uninfected drug users.~      To compare serum cotinine levels and spirometry results, as a marker of tobacco use and a~     marker of damage to lung function, respectively.~      Eligibility:~      Patients 18 years of age and older who are in the ALIVE cohort.~      Design:~      Patients undergo the following procedures:~        -  Completing a questionnaire on smoking history. Questions include age when smoking began,~          periods of quitting smoking, average number of cigarettes per day for specific periods,~          amount of each cigarette smoked, depth of inhalation, type of cigarette, nicotine~          dependence, use of other smoked [Note: I would not mention that these drugs are illegal]~          drugs, exposure to environmental tobacco smoke, past medical history, and recent~          respiratory symptoms.~        -  Spirometry testing. Patients are asked to breathe as deeply as possible and then rapidly~          exhale into a tube. The forced expiration volume in 1 second reflects the average flow~          rate during the first second, and it can be used to determine the degree of pulmonary~          obstruction.~        -  Blood samples. Tests measure levels of cotinine, a chemical made by the body from~          nicotine. African American males, who constitute the majority of the ALIVE cohort,~          participate in this test. Results would show how much tobacco smoke has recently entered~          the body. For this test, researchers plan to evaluate 240 current tobacco smokers and~          100 participants who report no recent cigarette use.~   "
234131|NCT00491322|"~     The purpose of this project is to determine if treating vitamin D deficiency decreases~     insulin resistance and improves insulin secretion in healthy volunteers. Additionally, this~     project will investigate if treating vitamin D deficiency affects a new phosphate-regulating~     hormone called FGF-23.~   "
234132|NCT00491309|"~     In Patients with rheumatic disease exercise training is a well established element of~     therapy. In contrast patients with severe pulmonary hypertension are advised to avoid~     physical exertion and must not perform exercise training. This study aims to evaluate the~     effectivity and safety of a low-dose training program in patients with pulmonary hypertension~     and rheumatic disease.~   "
234133|NCT00491296|"~     PURPOSE: We determined whether Synergo therapy- intravesical chemotherapy instillation~     combined with hyperthermia instillation is associated with elevated prostate specific antigen~     (PSA). MATERIALS AND METHODS: We will treat 25 consecutive patients with bladder cancer with~     a 6-week course of Synergo therapy, followed by cystoscopy at 6 weeks. Blood samples for PSA~     determination will obtain before each synergo therapy application and at cystoscopy with each~     patient also serving as a control.~      Evaluating changes in PSA level in patients undergoing treatment with Synergo delivered local~     hyperthermia combined with intravesical instillation of Mitomycin C for adjuvant treatment or~     pt. with recurrent tu of bladder post TURT with BCGtreatment.~   "
234134|NCT00491283|"~     A comparative study of different swab types used for collection of specimens for rapid~     inluenza testing~   "
234135|NCT00491270|"~     To determine whether screening of pregnant women with history of previous preterm delivery or~     with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive~     women will reduce the risk of spontaneous preterm birth.~   "
234136|NCT00491257|"~     This study is designed to generate clinical data as outlined in the Note for Guidance on~     harmonization requirements for influenza vaccine marketing authorization by the European~     Medicines Agency.~      The objectives of the trial are:~        -  To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern~          Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for~          Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.~        -  To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008~          formulation.~   "
234207|NCT00490321|"~     The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing~     long-term circulatory support for patients who have chronic stage D heart failure and are~     ineligible for a heart transplant.~      This is a multi-center, prospective, randomized, controlled clinical trial, which is~     comprised of two independent modules.~   "
234137|NCT00491244|"~     Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon~     (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in~     immunocompetent patients. In dialysis patients, treatment with conventional or pegylated~     interferon has also received much attention recently. Two meta-analyses evaluating the~     efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic~     response (SVR) rates were 37% and 33%, respectively; and the corresponding dropout rates were~     17% and 29.6%, respectively.The efficacy and safety of pegylated IFN alfa-2a and 2b in~     treating dialysis patients showed conflicting results, with a more favorable outcome of~     patients treated with pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated)~     than those treated with pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated.~     Currently, IFN-based therapy to treatment HCV infection should be initiated in dialysis~     stages, because the use of IFN in RT patients harbors high risks of acute graft rejection,and~     have low response rates under the concomitant use of immunosuppressive agents.~      Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the~     general patients and achieve a higher SVR rate than IFN monotherapy, is considered~     contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe~     hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus~     low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of~     treatment. In addition, a recent study including 6 patients with combination of pegylated IFN~     alfa plus low dose ribavirin also showed a SVR rate of 50%. In this study, treatment with~     pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with~     pegylated IFN alfa-2b plus low dose ribavirin (100% vs. 25%).~      Based on the long-term favorable outcome in dialysis patients who eradicate HCV, and the~     superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b~     plus low dose ribavirin in treating dialysis patients with chronic hepatitis C, the aim of~     the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose~     ribavirin versus pegylated interferon alfa-2a alone in treatment naïve dialysis patients with~     chronic hepatitis C.~   "
234138|NCT00491231|"~     The aim of the study is to evaluate whether orthostatic hypotension is associated with~     nondipping hypertension.~      Methods and patients: 400 subjects who are referred for 24hABPM will be filled questioner~     regarding their medical background and medications. All patients will be subjected to~     orthostatic test before connection to the 24 ABPM. The orthostatic changes in blood pressure~     and heart rate will be correlated to the changes in blood pressure and heart rate from day to~     night as recorded by the 24H ABPM.~   "
234139|NCT00491218|"~     The current outpatient evaluation for angina in low and intermediate risk patients typically~     starts with a functional assessment for coronary ischemia. Exercise treadmill testing is~     often selected as the initial diagnostic modality for coronary artery function. However,~     exercise treadmill testing is limited by its moderate sensitivity and specificity, often~     resulting in further cardiac resource utilization for patient risk stratification and~     reassurance. With the advent of coronary multislice computed tomography (MSCT) angiography,~     coronary artery anatomy can now be evaluated noninvasively. Despite its impressive~     performance characteristics, the role of coronary MSCT angiography in the outpatient~     evaluation of angina remains undefined.~      CT-EXTRA compares the impact on patient safety and downstream resource utilization of a novel~     initial diagnostic strategy employing the addition of coronary MSCT angiography to exercise~     treadmill testing with a standard diagnostic strategy of exercise treadmill testing for the~     ambulatory evaluation of low-intermediate risk patients with possible angina. The study is a~     single center, prospective, non-blinded, randomized clinical trial. Men and women, age 18-70,~     with a low to intermediate pretest probability of coronary artery disease who are referred~     for an exercise treadmill test for angina are eligible. Subjects are randomized either to an~     initial diagnostic strategy of exercise treadmill testing or exercise treadmill testing with~     coronary MSCT angiography. Subsequent diagnostic testing and treatment are the discretion of~     the referring physician. Subjects will be clinically followed for 24 months.~      The clinical impact on patient safety and downstream clinical resource utilization of this~     novel diagnostic strategy in which both coronary artery anatomy and function are initially~     evaluated will be determined. The primary outcome is a composite endpoint consisting of~     freedom from adverse cardiac events, further cardiac diagnostic testing, and future cardiac~     clinical encounters. Secondary outcomes include the impact on the indiscriminate use of~     coronary angiography, subject anxiety, depression, motivation for healthy behavioral change,~     and satisfaction with diagnostic evaluation and use of antiplatelet and antilipid therapy.~     Lastly, the cost effectiveness of the routine addition of coronary MSCT angiography in the~     outpatient evaluation of possible angina will be determined.~   "
234140|NCT00491192|"~     The purpose of our study is to verify wherever normothermia (achieved with diclofenac~     administration) may improve intracranial pressure control and may limit secondary cerebral~     damage thus positively influencing outcome in patients with acute cerebral damage admitted to~     ICU.~   "
234141|NCT00491179|"~     Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon~     (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in~     immunocompetent patients. Two meta-analyses evaluating the efficacy and safety of~     conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates~     were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29.6%,~     respectively. The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis~     patients showed conflicting results, with a more favorable outcome of patients treated with~     pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with~     pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated), Currently, IFN-based~     therapy to treatment HCV infection should be initiated in dialysis stages, because the use of~     IFN in RT patients harbors high risks of acute graft rejection,and have low response rates~     under the concomitant use of immunosuppressive agents.~      Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the~     general patients and achieve a higher SVR rate than IFN monotherapy, is considered~     contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe~     hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus~     low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of~     treatment.In addition, a recent study including 6 patients with combination of pegylated IFN~     alfa plus low dose ribavirin also showed a SVR rate of 50%.~      Although dialysis patients have a higher SVR rate to conventional IFN or pegylated IFN~     monotherapy than patients with normal renal function for HCV therapy. More than half of these~     patients are relapsers or non-responders to IFN monotherapy. Retreatment of HCV-patients with~     normal renal function by combined pegylated IFN alfa plus ribavirin who fail to response to~     IFN monotherapy has achieved a SVR rate of 28%. Based on the long-term favorable outcome in~     dialysis patients who eradicate HCV, the aim of the study is to evaluate the efficacy and~     safety of retreatment by pegylated IFN alfa-2a plus low dose ribavirin in dialysis patients~     who fail to achieve HCV eradication by conventional or pegylated IFN alfa.~   "
234142|NCT00491166|"~     This is an investigator-sponsored trial (IST), an open-label pilot study, assessing the~     safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser.~   "
234143|NCT00491153|"~     The purpose of this study is to estimate the sensitivity, specificity and positive and~     negative predictive values of a positive Aridol challenge with respect to a specialist~     pulmonologist diagnosis of asthma in corticosteroid naive subjects with asthma-like symptoms~     and no previous diagnosis of asthma. The comparator is methacholine provocation~   "
234144|NCT00491140|"~     The primary objective is to identify molecular features predicting response or resistance to~     cetuximab~   "
234145|NCT00491127|"~     The purpose of this study it to evaluate efficacy of gemcitabine with cisplatin and~     dexamethasone in patients with aggressive non-Hodgkin's lymphoma who have previously~     progressed on first line of chemotherapy with anthracyclines.~   "
234146|NCT00491114|"~     This is a phase II study where chemotherapy (gemcitabine) is given into the urinary bladder.~   "
234147|NCT00491101|"~     The aim of the study is valuation of quality of life (QL) in children with asthma and~     analysis of the factors that can have influence on it. The clinical problems included into~     the aim are to evaluate:~        -  the correlation between the QL and asthma control~        -  the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding~          of each question and it's answers The results of this study can be very helpful in the~          future in developing a questionnaires to use in Polish Primary Care, according to which~          the investigators would be able to see whether the asthma in our patients is being well~          controlled.~   "
234148|NCT00491088|"~     Specific Aim:~        1. To prove our hypothesis that in severe OSA patients without daytime sleepiness, CPAP~          worked as effectively as in severe OSA patients with daytime sleepiness.~           Using sham CPAP as the optimal placebo, we conduct a randomized double-blind placebo~          controlled trial to assess the CPAP effect in severe OSA patients without daytime~          sleepiness.~        2. To establish a model to predict the CPAP effect We use the parameters of five aspects,~          including changes of polysomnographic parameters, improvement of sleepiness, fatigue and~          QOL, sympathetic activity, inflammatory mediators and metabolism, to establish a model~          to predict CPAP effect.~   "
234149|NCT00491075|"~     Primary Objective:~        -  To determine the clinical activity of Pemetrexed + Gemcitabine in non-clear cell renal~          cell cancer (RCC). Clinical activity will take into account response rate and~          progression free survival (PFS).~      Secondary Objectives:~        -  To determine the toxicity of Pemetrexed + Gemcitabine in non-clear cell RCC.~        -  To estimate the survival rate of patients with non-clear cell RCC treated with this~          combination.~   "
234150|NCT00491062|"~     The core of the neuronal lesions in Parkinson's disease (PD) is the progressive~     degeneration of dopamine neurons in the substantia nigra. A significant loss of dopamine~     neurons and the presence of Lewy bodies (a pathological hallmark in PD) in enteric neurons~     have also been reported in that disease. These lesions may explain the frequent~     gastro-intestinal dysfunction observed in PD patients. Alterations of other neuronal~     populations within the enteric nervous system (ENS) as well as the mechanisms responsible for~     these lesions (type of cell death, alteration of neuromediators gene expression) remain to be~     identified. The aim of the study is to demonstrate that alterations of the human ENS in PD~     can be evidenced by bowel biopsies and to determine whether they are correlated to the~     severity of motor disability and to gastrointestinal dysfunction.~   "
234151|NCT00491049|"~     The purpose of this study is to determine whether additional topical application of 0.5%~     levofloxacin is more effective in reducing the load of the conjunctival bacterial flora in~     patients scheduled for intraocular surgery than preoperative irrigation of the conjunctiva~     with povidone iodine alone.~   "
234152|NCT00491036|"~     Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to~     a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related~     artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion~     criteria computerized randomization is performed to either PCI plus intraaortic balloon pump~     (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care~     treatment is performed according to standard care including hemodynamic monitoring using a~     pulmonary artery catheter for optimal volume status adaptation and inotropic drug~     administration.~      The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be~     30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and~     clinical parameters will serve as surrogate for prognosis of the patients.~   "
234153|NCT00491023|"~     Our aim in this study is to find out if we can locate the similar reduction in the~     recruitment of macrophages, remodeling of vasculature and do they correlate in the number and~     area of the islets in pancreas as in the mouse model.~   "
234154|NCT00491010|"~     Patients undergoing atrial flutter ablation will be randomized to either the standard~     ablation approach or voltage targeted approach. Patients will be followed for one year to~     assess outcome of the ablation technique~   "
234155|NCT00490997|"~     The objective of this study is to compare Ketamine-Propofol with Ketamine-only in a~     double-blind, randomised, controlled trial in a paediatric emergency department. We believe~     that the combination of these two agents will provide a new and more effective option for~     procedural sedation in paediatric emergency department patients. The hypothesis of the study~     is that paediatric emergency department patients requiring procedural sedation for an~     isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time,~     time to recovery, complications and improved satisfaction scores compared to patients~     receiving Ketamine alone.~   "
234156|NCT00490984|"~     The objective of this study is to assess the feasibility, safety and effectiveness of tongue~     stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep~     apnea (OSA). Success is defined as a statistically significant reduction in AHI measured by~     polysomnography (PSG) from baseline to 6 months.~   "
234157|NCT00490971|"~     The purpose of this study is to evaluate the effectiveness and safety of oral~     extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence~     of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an~     acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active~     control arm, although the study is not designed to allow for a direct comparison of~     olanzapine with paliperidone.~   "
234158|NCT00490958|"~     Background: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high~     mortality rate but, presently, very little data is available regarding this population.~      Aim of the study: Aim of this study was to determine whether telmisartan decreases all-cause~     and cardiovascular mortality and morbidity in haemodialysis patients with CHF and impaired~     left ventricular ejection fraction (LVEF) when added to standard therapies with ACE~     inhibitors.~      Methods: A 3-year randomized, double-blind, placebo-controlled, multicentre trial was~     performed involving 30 Italian clinics. Haemodialysis patients with CHF (NYHA class II and~     III; LVEF 40%) were randomized to telmisartan or placebo in addition to ACE inhibitor~     therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was~     titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35±5~     months. Primary outcomes were all-cause mortality, cardiovascular mortality and CHF~     hospitalization.~   "
234159|NCT00490945|"~     The purpose of this study is to assess the safety and efficacy of VEC-162 compared to~     matching placebo on circadian phase shift and sleep parameters.~   "
234160|NCT00490932|"~     For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based~     Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of~     the cause or age group affected. This product has proven effective and contributed~     substantially to the dramatic global reduction in mortality from diarrhoeal disease during~     the period.~      Based on more than two decades of research and recommendations by an expert group, WHO and~     UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose~     and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF~     recommended that countries use and manufacture this new formulation in place of the old one.~     While recommending this new ORS the experts also recommended that further monitoring is~     desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of~     sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the~     new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including~     cholera. If the new ORS is found safe, it will provide added confidence in its global use.~   "
234278|NCT00489398|"~     Comparison of two allergy drops for enhancing comfort and performance of contact lens wear~   "
234161|NCT00490919|"~     The objective of this study is to determine the analgesic efficacy and safety of~     Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve~     subjects with moderate to severe chronic low back pain. The double-blind treatment~     intervention duration is 12 weeks, during which time supplemental analgesic medication~     (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or~     ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in~     addition to study drug.~   "
234162|NCT00490906|"~     The purpose of this study is to determine if certain drugs commonly used to treat multiple~     sclerosis have an effect on bone health.~   "
234163|NCT00490893|"~     Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in~     patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and~     physicochemical properties which differ from human insulin. The aim of the present study is~     to test whether this leads to altered hormone and symptom response during hypoglycemia.~   "
234164|NCT00490880|"~     The purpose of this study is to evaluate efficacy of gemcitabine and cisplatin combined with~     either radical cystectomy or radiotherapy in the treatment of bladder cancer.~   "
234165|NCT00490867|"~     In the present study, endothelium dependent vasodilation will be induced by administration of~     acetylcholine (ACh). To ascertain whether the vascular effects, if any, of α-lipoic acid are~     limited to the endothelium, endothelium independent vasodilation will also be assessed by~     administration of glyceroltrinitrate (GTN).~      Study objectives To investigate the effect of α-lipoic acid therapy on endothelium dependent~     and independent vasodilation, assessed by forearm blood flow (FBF), in patients with type 2~     diabetes mellitus~      Study design~      Randomized, double-blinded, parallel group study for 23 days:~      Day 1: FBF responses to acetylcholine and glyceroltrinitrate Day 2-22: intravenous infusion~     of 600 mg α-lipoic acid or placebo Day 23: FBF responses to acetylcholine and~     glyceroltrinitrate~      Study population 30 subjects with type 2 diabetes~      Study medication Acetylcholine (ACh) - intraarterial infusion, 25, 50, 100 nmol/min, infusion~     period 3 minutes/dose level Glyceroltrinitrate (GTN) - intraarterial infusion, 4, 8, 16~     nmol/min, infusion period 3 minutes/dose level α-lipoic acid - intravenous infusion of 600 mg~     in 250 ml saline solution over 30 minutes~      Main outcome variables Forearm blood flow (Ratio between intervention and control arm)~     Additional outcome variables Arterial blood pressure, pulse rate, markers of inflammation and~     oxidative stress, Insulin plasma levels, Glucose plasma levels~      Risk/benefit assessment The insertion of intravenous cannula may cause mild and transient~     pain. A minor hematoma may occur at the site of cannula insertion. The insertion of the~     intraarterial cannula is performed under local anaesthesia and causes mild pain. The~     meassurement of forearm bloodflow, espacialy the wrist cuff (>200 mmHG) may be uncomfortably.~     Local administration of drugs through a needle in the brachial artery allows the study of~     direct vascular effects of the drugs. Drug doses are 100 to 1000 times lower than a systemic~     effective dose, therefore no systemic adverse events are expected. There is experience in~     brachial artery infusions at our institution, and it is considered a safe technique. α-lipoic~     acid was well tolerated in healthy volunteers and subjects with diabetes at doses up to 600~     mg intravenously and 1800 mg orally with side effects comparable with placebo. Altogether 50~     ml blood will be collected throughout the study.~   "
234166|NCT00490854|"~     The purpose of the study is to compare the human insulin inhalation powder plus oral~     anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus~     oral anti-hyperglycemic medication on lowering the blood sugar level.~   "
234167|NCT00490841|"~     The purpose of this study is to determine whether the Herculink Elite Renal Stent System is~     safe and effective in the treatment of renal artery stenosis in patients with less than~     optimal angioplasty results and uncontrolled hypertension.~      CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by~     Federal (U.S.) Law to Investigational Use Only.~   "
234168|NCT00490828|"~     Hydrocortisone has been shown to improve the early outcome of high risk patients after~     cardiac surgery. A potential mechanism resulting in this effect may be its immunomodulatory~     action. In this prospective interventional study this hypothesis is to be proven.~   "
234169|NCT00490815|"~     This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert~     of fluocinolone acetonide for the treatment of diabetic macular edema~   "
234170|NCT00490802|"~     The purpose of this study is to learn whether or not the drug called oxytocin is helpful in~     improving mood and social functioning in adults with autism.~   "
234171|NCT00490789|"~     The purpose of this study is to determine the safety and efficacy of the mTOR inhibitor~     sirolimus as a treatment for renal angiomyolipomas in patients with tyberous sclerosis~     complex or sporadic lymphangioleiomyomatosis.~   "
234172|NCT00490776|"~     This study will evaluate the safety and efficacy of LBH589B in adult patients with~     refractory/resistant Cutaneous T-Cell Lymphoma and prior HDAC inhibitor therapy.~   "
234173|NCT00490763|"~     The goal of this clinical research study is to find out if men who have a type of prostate~     cancer that has been classified as low risk can safely not be treated for the disease.~     Doctors want to know if patients with low risk cancer can avoid or postpone therapy and the~     related side effects and still live as long as patients who immediately receive therapy.~      This is an investigational study. There are no medications used in this trial.~      About 1,000 patients will take part in this study. All will be enrolled at MD Anderson.~   "
234174|NCT00490750|"~     The primary aim of this study is to test the hypothesis that Heller myotomy and Toupet~     fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when~     compared to Heller myotomy and Dor fundoplication.~   "
234175|NCT00490737|"~     This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.~   "
234176|NCT00490724|"~     The purpose of this exploratory study is to assess the efficacy and safety of nesiritide in~     participants with acute (a quick and severe form of illness in its early stage) heart failure~     (when the heart inadequately pumps blood through the body) including acute exacerbation of~     chronic (lasting a long time) heart failure, administered intravenous (into a vein) bolus (a~     large amount) followed by intravenous infusion (a fluid or a medicine delivered into a vein~     by way of a needle).~   "
234177|NCT00490711|"~     The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed~     by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.~   "
234178|NCT00490698|"~     Objectives:~      Primary:~      Evaluate clinical outcome based on the time to skeletal events after bone-targeted therapy~      Secondary:~        1. Evaluate clinical outcome based on the presence of calcification at the site of~          osteolytic metastases~        2. Measure bone-formation and resorption markers at baseline and during bone-targeted~          therapy.~        3. Assess effect of the bone-targeted regimen on serum cholesterol levels~   "
234179|NCT00490685|"~     The aim of the study is to evaluate, after radiological progression, efficacy in patients~     treated with Sorafenib at a dose of 600 mg bid compared to that in patients treated with best~     supportive care.~      Primary efficacy objective is progression free survival from randomization.~   "
234180|NCT00490672|"~     Randomized controlled trial of CORFIS Programme.~      The study objectives are as follows:~        1. To determine the efficacy of a community based multiple risk factors interventional~          strategy (CORFIS) for a treatment period of 6 months in patients on treatment for HT, DM~          or HL.~        2. The intervention shall consist of a purpose design and systematically organized disease~          management program that employ multi-faceted interventions incorporating various~          specific measures to maximize both clinician (as investigator) adherence with treatment~          guideline and patient adherence with treatment.~   "
234181|NCT00490659|"~     The purpose of this study is to test feasibility, toxicity and efficacy of two different~     adjuvant treatment schedules in Stage II-IIIa Non-small cell lung cancer patients with~     positive lymph nodes.~   "
234182|NCT00490646|"~     The purpose of this randomized, Phase 2 open-label study was to assess the response rate of~     participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or~     metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to~     treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.~   "
234183|NCT00490633|"~     Pharmaceutical interventions, particularly vaccination, have been the principal public health~     method of preventing and controlling seasonal influenza. Other less invasive~     non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia,~     masks are used extensively, especially in Japan, but with only circumstantial evidence of~     efficacy. Although there are numerous studies that support hand hygiene as an effective~     measure for decreasing transmission of enteric infections, there are fewer data assessing the~     effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be~     conducted on the use of face masks with and without the use of hand hygiene in comparison to~     no intervention in residence housing units of the University of Michigan. The interventions~     will be carried out during a period of influenza transmission that is defined by surveillance~     conducted at the University Health Service. Data will be collected on use of the~     interventions and the occurrence of influenza and other illnesses. When illness occurs~     meeting a case definition, specimens for viral isolation will be collected in all~     intervention settings. Face masks could theoretically lead to a large reduction in~     transmission frequency of influenza, especially if most transmission occurs by the airborne~     (large or small droplet) route. Even a modest reduction could have a major effect during an~     influenza pandemic.~   "
234184|NCT00490620|"~     This is a proof of principal study to determine whether combination anti-viral therapy with~     Combivir impacts on hepatic biochemistry in patients with primary biliary cirrhosis~   "
234185|NCT00490607|"~     The purpose of this study is to investigate the pathogenesis of hemangiomas of infancy as~     they relate to normal pregnancies and those pregnancies complicated by placenta~     abnormalities. Women of all gestational ages will be enrolled in the study. Maternal serum,~     placental, and cord blood samples will be obtained for each subject. A medical history will~     be obtained for each subject. Post-delivery a member of the study team will perform a~     cutaneous exam of the infant to establish what birthmarks are present at birth. Mother will~     receive four phone call follow ups to determine if the infant has had any skin changes. If~     yes, mother will be asked to bring the child in for evaluation. If a hemangioma is diagnosed,~     a blood draw will be performed.~   "
234186|NCT00490594|"~     The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is~     taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver)~     for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with~     SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is~     designed to be a temporary support structure to replace the torn ACL and to stabilize the~     knee joint following surgical repair. It is designed to use the body's own healing process to~     regenerate the patient's own new ligament tissue. As the new tissue grows and the support~     structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by~     the patient's body. The SeriACL device is designed to be installed with standard surgical~     techniques for ACL repair.~      This study is designed to test the safety of the SeriACL device in primary total ACL repair~     in patients with a torn ACL. The study will evaluate whether repair of the ACL with the~     SeriACL device will return the knee to normal function and what, if any, side effects will~     occur.~   "
234187|NCT00490581|"~     The study hypothesizes that early housing after hospitalization with case management~     integrated into the health and housing systems, will results in decreased use of costly~     health services (i.e., hospitalizations and Emergency Room visits) with no negative affect on~     health. To address this hypothesis the investigators implemented a Randomized controlled~     trial of 407 homeless adults with chronic medical illness in Chicago. Eligible homeless~     adults were enrolled during a hospitalization to intervention - Early housing with case~     management - or usual care - usual case management and housing options. The investigators~     followed the sample for 18 months with assessments at baseline, 1,3,6,9,12 and 18 months are~     enrollment. Study measures include Quality of Life, Health service use, Alcohol and Substance~     Use, housing and social and demographic characteristics.~   "
234188|NCT00490568|"~     This is a Phase III, multicenter, open-label extension, single-group study in male and female~     outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either~     AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg~     once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to~     their existing dose of acetylcholinesterase inhibitor. Subject participation will last until~     one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend~     a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this~     study is to evaluate the long-term safety and tolerability of RSG XR in subjects with~     mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective~     of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive~     function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele~     status.~   "
234208|NCT00490308|"~     To evaluate whether treatment with Estradiol supplementation during the luteal phase improves~     IVF outcomes~      Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a GnRH~     analog will receive 4 mg estradiol valerate in the luteal phase.Patient's followup will~     include E2 progesterone and BHCG 14 days after embryo transfer and vaginal ultrasound on day~     21 and 28 after embryo transfer~   "
234189|NCT00490555|"~     The investigators propose to examine the in vivo responses to hormonal manipulation at the~     molecular level directly in the tissue of interest (prostate). As in the investigators'~     previous, pilot study, the investigators will use the novel approach of procuring tissue~     specimens from normal, healthy men who might be chose to use a male hormonal contraceptive~     regimen were it available. The investigators will employ state of the art techniques such as~     laser capture microdissection (LCM) and cDNA microarrays to determine the tissue-specific~     consequences of male hormonal contraceptive regimens on the prostate. The results will help~     guide the design, safety monitoring, and selection of male hormonal contraceptive agents and~     provide valuable insights into prostate human prostate biology.~      The investigators will test the hypothesis that exogenous T administration that results in~     increased circulating T and dihydrotestosterone (DHT) levels will increase intraprostatic~     concentrations of T and its metabolite DHT.~      The investigators will test the hypothesis that the addition of a potent 5α-reductase~     inhibitor, dutasteride, or the progestin, Depomedoxyprogesterone (IM DMPA), to T~     administration in young and middle aged men will decrease intraprostatic DHT and increase~     intraprostatic T concentrations compared to T alone.~      The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor~     dutasteride or the progestin IM DMPA to exogenous T, by reducing intraprostatic DHT, will~     decrease prostate epithelial proliferation, assessed by Ki-67 labeling index (Ki-67LI), and~     increase apoptosis, assessed by caspase-3 expression, and decrease androgen-regulated protein~     expression such as prostate specific antigen (PSA).~      The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor or~     the progestin IM DMPA to exogenous T, by modifying the intraprostatic hormonal milieu, will~     alter prostate epithelial gene expression. Specifically, the investigators expect that the~     addition of the 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T,~     will result in decreased expression of androgen-regulated genes such as PSA.~   "
234190|NCT00490542|"~     Mixed states in bipolar disorder have long been recognized. Over a century ago, it was argued~     that mixed states were the most common episodes in manic-depressive illness. A mixed state is~     defined as a person who is experiencing symptoms of both depression and mania.~      Currently, a person must have depression plus 3 or more manic symptoms for the episode to be~     diagnosed mixed. Using this narrow view, less than 10% of episodes in patients with bipolar~     disorder would meet criteria for a mixed episode. A broader view requires that the person~     have at least 2 manic symptoms. Using this broader view, data suggest that about 50% of~     episodes in bipolar disorder would be diagnosable as mixed states.~      Studies suggest that the majority of persons with a depressive mixed state have bipolar~     disorder type II. Many people who have a mixed state will also have major depression. Even~     with such high potential rates of mixed episodes in both bipolar disorder and major~     depression, there have been few studies addressing the issue.~      The purpose of this study is to look at how effective Geodon is in treating the depressive~     mixed state in people with bipolar or major depression. This will be the first clinical trial~     that is both double-blind and randomized.~   "
234191|NCT00490529|"~     Mantle Cell Lymphoma is a sub-type of Non-Hodgkin's Lymphoma which is generally considered~     incurable with current therapy. Our goal is to accrue 59 patients who receive an autologous~     vaccine against their individual lymphoma after undergoing stem cell transplantation. Our~     hope is that vaccination will prolong the time which patients will stay in remission from~     their disease.~   "
234192|NCT00490516|"~     This is a randomized, double-blind, placebo-controlled parallel-group, 6-week study,~     evaluating two dose levels of ACP-104 or Placebo twice a day in patients with schizophrenia~     who are experiencing an acute psychotic episode.~   "
234193|NCT00490503|"~     The goal of this clinical research study is to learn if magnetic resonance imaging (MRI) with~     magnetic resonance spectroscopy (MRS) can show the effects of pre-surgical chemotherapy in~     breast cancer patients who are eligible to receive preoperative chemotherapy.~   "
234194|NCT00490490|"~     The purpose of the study is to assess the response rate of patients with relapsed or~     refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma~     to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy~     (XRT).~   "
234195|NCT00490477|"~     Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal~     dysfunction in patients with severe sepsis from gram negative infection.~   "
234196|NCT00490464|"~     The purpose of this research is to explore ways to improve and simplify control of blood~     pressure in patients with SAH or ICH. This research will be done by comparing tow different~     medications that are routinely used to help control blood pressure. None of the medications~     used in this study nor any procedures performed are experimental.~   "
234197|NCT00490451|"~     The primary purpose of the study is to estimate the time from the first dose of~     LY573636-sodium (hereafter referred to as LY573636) to the date your physician determines~     that your disease has progressed or worsened.~   "
234198|NCT00490438|"~     The patients will be submited to a vaginal squeeze pressure measurements before and after~     surgeries for urinary incontinence.~   "
234199|NCT00490425|"~     Given that asthma results from a complex interaction between genetic susceptibility and~     environmental factors and rates of childhood asthma are increasing, primary prevention has to~     focus on modifiable aspects such as nutrition. There a implications from epidemiology that~     food supplementation with probiotics given to atopic mothers in pregnancy and during~     lactation can prevent the development allergies in the offspring. Children with atopic~     dermatitis are at increased risk (up to 80%) of developing persistent respiratory tract~     disease. Our trial examined whether probiotics are able to prevent allergic sensitization and~     allergic asthma when given to 6-24 month old infants at an increased risk of allergies.~   "
234200|NCT00490412|"~     The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone~     loss, which are common in HIV infected adolescents and young adults being treated with~     tenofovir.~   "
234201|NCT00490399|"~     The purpose of this study is to evaluate the efficacy of gemcitabine and cisplatin in Korean~     patients with biliary tract (bile tracts of the gallbladder or liver) cancer.~   "
234202|NCT00490386|"~     This study is performed to measure wether Helicobacter Pylori has an effect on the incidence~     and course of acute alcohol induced pancreatitis~   "
234203|NCT00490373|"~     This study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer~     who progressed after first line chemotherapy with gemcitabine.~   "
234204|NCT00490360|"~     Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable~     cancer of pancreatic head.~   "
234205|NCT00490347|"~     The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD~     in providing circulatory support for patients who require an LVAD as a bridge to cardiac~     transplantation.~   "
234206|NCT00490334|"~     This research involves assessment of cognitive outcome in childhood cancer as well as~     evaluation of a cognitive rehabilitation program for improving learning and problem solving~     difficulties in children with cancer.~   "
234222|NCT00490126|"~     The goal of this clinical research study is to collect information on patients who had or are~     going to have laparoscopy performed at M. D. Anderson. Researchers want to use this~     information to learn the effects of laparoscopic surgery on patients over time.~   "
234209|NCT00490295|"~     Brain injury occurs in one-quarter to one-half of congenital heart defect infants during the~     perioperative period. A blood test using a biomarker to diagnose brain injury would be~     important.~      Postoperative cerebral ischemia may be decreased by inotropic support, ventilation, medical~     management aimed at increasing oxygen delivery to the brain. Currently there are no FDA~     approved blood tests to assess brain ischemia in infants undergoing cardiac surgery.~      Specific Aim 1: We will prospectively study 10 neonates (< 30 days of age) undergoing cardiac~     surgery utilizing cardiopulmonary bypass for arterial switch operation or Norwood operation~     to determine the specificity and sensitivity of a blood test for brain injury. This aim will~     be accomplished by analyzing blood samples for S-100 and NSE drawn prior to surgery, once~     each day following cardiac surgery as long as the patient remains in the intensive care unit~     (maximum 5 days)and at the time of postoperative brain magnetic resonance imaging. The S-100B~     and NSE values will then be correlated with brain magnetic resonance imaging studies before~     cardiac surgery and at following cardiac surgery.~      Hypothesis: We expect the concentration of S-100B and NSE will be significantly higher in the~     blood of neonates with congenital heart disease who have documented brain injury on brain~     magnetic resonance imaging (MRI). Furthermore, we predict that the blood levels of S-100B and~     NSE may correlate to clinical outcome (time to extubation, hospital discharge,~     neurodevelopmental outcome at 6 months of age).~      Specific Aim 2: We will prospectively study these neonates at 6 months following cardiac~     surgery to determine a correlation between neurodevelopment and concentration of S-100B and~     NSE. To achieve this specific aim, a blood sample for S-100B and NSE and neurodevelopmental~     testing will be done at 6 months following cardiac surgery.~      Hypothesis: We expect neonates with elevated S-100B and NSE and abnormal brain magnetic~     resonance imaging documented in specific aim 1 to have a significant decline in~     neurodevelopment at 6 months after cardiac surgery.~      Long-term: The long-term goal of this research is to diagnose brain ischemia in infants using~     a biomarker blood test.~   "
234210|NCT00490282|"~     The goal of this clinical research study is to use computed tomography (CT) scans to measure~     and guide your radiation therapy. Researchers want to learn if the CT scans can be used to~     adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor~     that may occur as a reaction to radiation therapy. Researchers also want to see if magnetic~     resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than~     with standard tests.~   "
234211|NCT00490269|"~     This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on~     withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety,~     pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and~     smoked marijuana to determine if there are potential significant drug interactions before~     conducting outpatient studies.~   "
234212|NCT00490256|"~     Even though the lower part of the body does receive some blood supply during Cardiopulmonary~     Bypass(CPB) surgery, it may not be enough. As a result of this lowered blood supply, there~     are complications associated with CPB and clamping of the aorta. These include complications~     with the stomach, intestines and kidneys.~      The hypotheses of this study are that increased lower body perfusion during aortic arch~     reconstruction will decrease intestinal ischemia and the incidence of necrotizing~     enterocolitis, improve renal function in the postoperative period, and shorten both intensive~     care unit and hospital length of stay.~      The purpose of this research study is to provide the lower part of the body and its organs~     with possibly more blood supply with a modified form of cardiopulmonary bypass and see if~     this additional blood supply helps to decrease complications of the kidney, stomach and~     intestines.~   "
234213|NCT00490243|"~     The present study was conducted to determine the effects of four week treatment with~     budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in~     children with atopic asthma on lung function: forced expiratory volume in one second,~     mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique,~     plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and~     clinical symptoms.~   "
234214|NCT00490230|"~     Primary Objectives:~      Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the~     cosmetic outcome compared with no treatment (natural healing)~   "
234215|NCT00490217|"~     Spontaneous bacterial peritonitis (SBP) is a severe complication of ascites in cirrhotic~     patients. Under clinical experience, this condition seems to be more uncommon in Finland. The~     aim of this study was to measure the incidence of SBP in consecutive patients with ascites~     requiring hospitalization in a Finnish University Hospital.~   "
234216|NCT00490204|"~     Study objective is to verify the superiority of CTZ DS to the placebo groups in the change of~     total nasal symptom score (TNSS) over the total treatment period from the score of the~     baseline assessment period.~   "
234217|NCT00490191|"~     This study tested whether a dose regimen of growth hormone based on body weight is equivalent~     or better than starting with a low dose and gradually increasing the dose according to~     individual patient needs. Efficacy of the two regimens were assessed from changes in body fat~     measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of~     the study and at the completion of the study eight months later.~   "
234218|NCT00490178|"~     The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose~     combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia~   "
234219|NCT00490165|"~     This is a retrospective chart review of patient records at the University of Mississippi~     Medical Center. We are not actively recruiting patients for this study. Recent animal studies~     we conducted showed that periapical abscesses during pregnancy cause a systemic inflammatory~     response in the mother. Also due to the increase in TNF-alpha (an inflammatory cytokine) the~     mother also become insulin resistant and thus developed gestational diabetes. Periodontal~     inflammation has been shown in the research to lead to low-birth weight and pre-term birth.~     We are looking retrospectively to see if an association exists in charted data between~     periapical and periodontal inflammation and adverse pregnancy outcomes.~   "
234220|NCT00490152|"~     ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability,~     and attitudes among sexually active young women~   "
234221|NCT00490139|"~     This is a randomised, open label multi-centre phase III study comparing the activity of~     lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus~     lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2~     overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of~     two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will~     be randomised to one of four treatment regimens within each design schema.~      The primary objective of this study is to compare disease-free survival (DFS) in patients~     with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one~     year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned~     design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks,~     according to assigned design) versus trastuzumab in combination with lapatinib for one year~     (52 weeks). Secondary objectives include treatment comparisons with respect to overall~     survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence~     of brain metastasis, and analyses conducted separately for cohorts of patients defined by~     presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or~     absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring~     Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the~     comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary,~     indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to~     demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS).~     The IDMC also stated that the other three arms (trastuzumab alone, sequential~     trastuzumab/lapatinib arm and the combination arm) should continue as planned with no~     changes.~   "
234224|NCT00490100|"~     This study will evaluate the safety and effectiveness of insulin-like growth factor-1 (IGF-1)~     to treat patients with X-linked severe combined immunodeficiency (XSCID). Those who have~     XSCID lack white blood cells that protect their bodies from invasion by all types of germs.~     IGF-1 is the main hormone responsible for the body's growth and metabolism. As a medication,~     IGF-1 is Increlex[(Trademark)] (mecasermin),~      Patients ages 2 to 20 who have not yet begun puberty, have a diagnosis of XSCID, and are~     shorter than the 3rd percentile for their age may be eligible for this study. This study will~     last about 3 years, and patients' visits will be scheduled at 3-month intervals. Patients~     will have a physical history and exam, X-rays, electrocardiogram, blood tests, and body~     measurements.~      Patients will take estradiol orally for 2 days, to help avoid false results of growth hormone~     (GH) levels in blood samples. Then provocation testing is done, with two tests back to back.~     It determines blood levels of GH and the body's response to testing with drugs called~     arginine and clonidine. Patients are admitted to the pediatric inpatient unit and will have~     an intravenous (IV) line placed in the arm. Arginine is given by IV over 30 minutes, and~     blood samples are taken. Right after arginine testing, the clonidine tablet is given. The~     IGF-1 generation test is then done to see if the body makes IGF-1 as a product in response to~     injections of GH for 5 consecutive days. This test does not require that patients are~     inpatients, but after Day 8, patients must be admitted to the pediatric unit to have blood~     sampling, start Increlex injections, and start close monitoring of blood sugar levels. They~     will learn how to do a self-injection and follow other advice. They will complete records~     about the injection site, symptoms, and side effects-keeping records for at least the first 2~     days after going home, with each dose change, and as needed. Patients stick their fingertip~     and place a small drop of blood on a blood sugar monitoring strip. The strip is put into a~     glucometer-a small hand-held device to measure the blood sugar level. Patients will be~     instructed to always have a source of sugar available in case blood sugar is too low.~   "
234225|NCT00490087|"~     The study aims to evaluate the long-term efficacy and prognosis of hysteroscopic resection~     and coagulation of the base of endometrial polyps with focal atypia in fertile women.~   "
234226|NCT00490074|"~     The purpose of the trial is to evaluate the effect upon immune system of two regimens of~     preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by~     DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the~     vaccines. Volunteers will be followed during 72 weeks.~   "
234227|NCT00490061|"~     We propose to combine lapatinib with RT alone in patients with locally advanced head and neck~     cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the~     efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression~     (TTP) in this group of patients. In addition, we will determine the 2-year locoregional~     control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these~     patients. We will also evaluate the profile and frequency of late toxicity, specifically~     mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with~     locally advanced head and neck squamous cell carcinoma (HNSCC).~   "
234228|NCT00490048|"~     Ulcerative colitis is a systemic disease we assume that extra intestinal involvement as we~     describein our study( Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A Fireman E:~     Assessment of pulmonary involvement in Crohn’s disease by induced sputum. Am J Gastroenterol~     2000;95(30):730-734. )~   "
234229|NCT00490035|"~     This study will evaluate the efficacy and safety of Brivaracetam to support the submission~     file in the indication of adjunctive treatment in adolescents and adults with partial onset~     seizures.~   "
234230|NCT00490022|"~     The purpose of this research study is to understand the effects of a male hormone normally~     made in the body called Dihydrotestosterone (DHT) on the prostate gland that is located under~     the bladder. The knowledge gained from this study may be used to help in the future to~     develop a safe male hormonal contraceptive to prevent pregnancy, in the safe treatment of low~     male hormone levels in men, and in the treatment and prevention of diseases of the prostate.~      The investigators will be giving DHT in a gel form, to be applied to the skin, or a placebo~     gel (with no active drug in it). The investigators want to see the effects of DHT on levels~     of hormones in the blood and in the prostate gland itself. In addition, the investigators~     will be studying the effects of DHT on the cells and genes expressed within the prostate.~      The effect of DHT on the prostate is not known. Some studies suggest blocking production of~     DHT in the prostate helps growth of the gland with aging (a condition known as benign~     prostatic hyperplasia, or BPH for short) and may prevent prostate cancer. On the other hand,~     DHT administration may shrink the prostate, suggesting it may be beneficial for some men.~     Therefore, further studies looking at the effect of DHT on the prostate are needed.~   "
234231|NCT00490009|"~     The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with~     relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).~   "
234232|NCT00489996|"~     The purpose of this study is to evaluate response rate of the 3 week versus 4 week treatment~     of gemcitabine with cisplatin as the first line treatment for non-small cell lung cancer~     patients in China.~   "
234233|NCT00489983|"~     This study is for elderly patients who haven't been given prior chemotherapy or for patients~     who cannot be treated with platinum based chemotherapy. The patients who are eligible for~     this study will have been diagnosed with advanced or metastatic non-small cell lung cancer.~     The patients will be randomly assigned to one of two treatment options: single agent~     pemetrexed or single agent pemetrexed with single agent gemcitabine following right after the~     pemetrexed treatment.~   "
234234|NCT00489970|"~     The purpose of this study is to evaluate the persistence of antibodies against all the~     vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to~     assess immunogenicity and safety of another dose of Boostrix, administered in this study.~      This protocol posting deals with objectives and outcome measures of the extension phase. The~     objectives and outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00346073).~   "
234235|NCT00489957|"~     An echocardiogram, also called a cardiac ultrasound or echo, is a medical test that takes~     pictures of the heart using sound waves. It shows images of the structures of the heart~     without using radiation. During the last year, the FDA has approved a new technology called~     Speckle Tracking that can look at the heart wall motion and contraction (pumping or~     squeezing) abnormalities. The study will also employ tissue Doppler and 3-Dimensional echo~     and uses the same echocardiographic machines which are used right now. The machines are~     upgraded with the new software application. This new technology is currently being used in~     adults, but unfortunately, there is almost no published data about normal heart function in~     infants and children using this technology. It is known from other technologies that the~     developing child's heart is not the same as an adult.~      The investigators wish to study this new technology and compare it to other technologies~     currently being used.~   "
234236|NCT00489944|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking blood flow to the tumor~     and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such~     as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving sunitinib together with~     tamoxifen and cisplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving sunitinib~     together with tamoxifen and cisplatin works in treating patients with high-risk ocular~     melanoma.~   "
234237|NCT00489931|"~     This study will evaluate the safety and effectiveness of a vaccine to prevent avian influenza~     (bird flu). About 25 to 50 million cases of influenza occur a year in the U.S., leading to~     150,000 hospitalizations and 30,000 to 40,000 deaths. Globally, a pandemic influenza may be 1~     billion flu cases, with 3 to 5 million cases of severe illness and up to half a million~     deaths annually. There is potential threat of a pandemic from emerging virus strains for~     which the population has little or no preexisting immunity. Avian influenza A (H5N1) viruses~     causing serious disease have emerged recently, affecting domestic and wild bird populations.~      Patients ages 18 to 60 who are in good health and not pregnant or breast feeding may be~     eligible for this study. The study will be done at the NIH Clinical Center by staff of the~     Vaccine Research Center. It will last about 32 weeks for each person. A traditional needle or~     a needle-free device called Biojector 2000 will be used. Intramuscular (in the muscle) and~     subcutaneous (in fat below the skin) delivery of vaccine via Biojector is cleared for use by~     the Food and Drug Administration and is not considered investigational. Intradermal (in the~     skin) delivery of vaccine by Biojector in this study is deemed investigational but has been~     evaluated in humans before, and found safe and well tolerated in other trials.~      There will be about 10 clinic visits in this study, and it is important to stay on schedule.~     Visits are about 2 hours, though on injection days, visits are about 4 hours. Injections are~     given on day 0 and at weeks 4 and 8. The vaccine is given by injections in the skin on the~     upper arms. Clinic staff will observe patients for 30 minutes after each vaccination. One to~     2 days after the first injection, there will be a clinic visit. One to 3 days after the~     second and third injections, patients need to telephone clinic staff to report on how they~     are doing. Patients will complete a diary card at home, recording temperature and symptoms,~     and looking at the injection site daily for 5 days. Patients should report any side effects~     to one of the study physicians or nurses as soon as possible. They will return to the clinic~     2 weeks after each injection. A needle-free system uses the pressure of carbon dioxide,~     instead of a needle, to inject the vaccine into the skin. Discomfort can result from either~     the needle-free device or the needle. There may be stinging, pain, soreness, swelling,~     bruising, or a small cut in the skin.~   "
234238|NCT00489918|"~     A Multi-center study to determine effects of various doses of Macroflux PTH in women with~     osteoporosis~   "
234239|NCT00489905|"~     The purpose of this study is to assess the effect of zoledronic acid on bone mineral density~     in prostatic cancer patients currently receiving androgen deprivation therapy.~   "
234240|NCT00489892|"~     This study is designed to examine the effects of a wake-promoting agent (Modafinil) on~     working memory (WM) in persons with moderate to severe TBI utilizing a double blinded placebo~     controlled methodology. Our approach is to evaluate participants with BOLD fMRI and a limited~     neuropsychological battery to examine WM performance before and after pharmacological~     intervention.~      Hypotheses~        1. Because increased cognitive effort (as a function of decreased efficiency after TBI) is~          presumed to underlie fMRI activation dispersion that is seen during central executive WM~          tasks, we anticipate an attenuation of cerebral activation in prefrontal cortex during~          pharmacological intervention with Modafinil when compared to placebo administration on~          the mPASAT and vigilance testing.~        2. There will be a correlation between the decreased dispersion of the fMRI signal on scans~          and improvement in neuropsychological measures when individuals are on Modafinil that is~          not seen when they are taking placebo.~   "
234241|NCT00489879|"~     The purpose of this study is to determine whether cellular phone based health care system is~     effective in the treatment of diabetes and hypertension.~   "
234242|NCT00489866|"~     The proposed investigation will determine the therapeutic potential of aripiprazole~     augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder~     (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans~     with PTSD.~   "
234243|NCT00489853|"~     The purpose of this study is to investigate the effect on exercise tolerance, lung function~     and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic~     obstructive pulmonary disease.~   "
234244|NCT00489840|"~     Investigation to evaluate Anecortave Acetate in the treatment of chronic central serous~     chorioretinopathy~   "
234245|NCT00489827|"~     The main purpose of this study is to determine whether intravenous glutamate infusion given~     in association with surgery for unstable coronary artery disease can protect the heart from~     myocardial injury, postoperative heart failure and death.~   "
234246|NCT00489814|"~     The goal of this research study is to collect information on the side effects of proton~     radiation therapy given for the treatment of prostate cancer as well as the effect of proton~     therapy on quality of life. Information on your treatment and how you react to the treatment~     will be collected. Researchers will use this information to try to understand how people~     tolerate proton radiation therapy for prostate cancer.~   "
234247|NCT00489801|"~     Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based~     cardiac rehabilitation in patients older than 65 years.~   "
234248|NCT00489788|"~     Magnetic Resonance Imaging (MRI) is a non-invasive test that can look at the heart without~     using radiation. An MRI will allow the doctors to look at the heart in order to assess how~     well the ventricle is pumping, the amount of blood that it is pumping in addition to how much~     it is stretching. An engineer at Georgia Tech has developed a new way of looking at an MRI.~     It is believed that this new way of looking at an MRI may be better able to tell us when to~     replace the valve in these children. If this new process works, not only can we apply it now~     but we will be able to look at previously performed MRIs and gather more information about~     these children and their heart function in order to help these and other children in the~     future.~      We are planning on enrolling 30 subjects in this study. Some of the subjects will be enrolled~     and have their MRI strictly for the purpose of this study. Some of the subjects will be~     already scheduled for a routine MRI of their heart and we will ask them if we can do extra~     images for the study while they are already here.~   "
234249|NCT00489775|"~     To determine if duloxetine works just as well as paroxetine in the treatment of major~     depressive disorder.~   "
234263|NCT00489593|"~     The goal of this clinical research study is to find the highest tolerable dose of the drug~     Olanzapine that can be given to patients with advanced cancer who are experiencing weight~     loss. Researchers want to find out if Olanzapine can help decrease weight loss in patients~     who are experiencing it because of cancer. How this drug affects performance status,~     cancer-related symptoms, and nutritional status in patients with advanced cancer will also be~     studied.~   "
234250|NCT00489762|"~     The Housing, Heating and Health Study has enrolled 409 households with ineffective heaters,~     who have a child with asthma between 6 and 12 years.~      In the winter of 2005, houses were insulated and baseline measures taken of indoor~     temperatures, nitrogen dioxide, with more intensive indoor air quality monitoring in a~     sub-sample of 33 homes.~      Objective data are being collected on the household’s health and energy usage. The households~     randomly assigned to the intervention group will have new heaters installed over the summer.~      Results will be available after the follow-up data collection in 2006.~   "
234251|NCT00489749|"~     The purpose of this study was to determine the effect of protected early weightbearing (PEWB)~     compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on~     health related quality of life (HRQL) in the initial six week period after surgery,~     functional recovery over time, return to work and activity and complications. We hypothesized~     that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative~     period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work~     and sport, and iv) no increase in complications, such as re-rupture compared to NWB.~   "
234252|NCT00489736|"~     The objective of this study is to compare the efficacy and safety of dronedarone to that of~     amiodarone for the treatment of patients with atrial fibrillation.~   "
234253|NCT00489723|"~     The purpose of this study is to determine if there is a role of prophylactic therapy with~     tamsulosin prior extracorporeal shock wave lithotripsy to avoid development of steinstrasse.~     150 persons that will go to Extracorporeal shock wave lithotripsy will randomize to 2 groups.~      Group 1 -of 75 persons will recieve tamsulosin 0.4 mg x 1/d 2 days before the lithotripsy .~      Group 2 - of 75 persons will not recieve tamsulosin. 48 hour after the ESWL all 2 group will~     take abdominal radiograph to evaluate the presence of steinstrasse.~   "
234254|NCT00489710|"~     RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well talabostat works in treating patients with~     metastatic kidney cancer.~   "
234255|NCT00489697|"~     Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a~     new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound~     with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly~     hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies.~     The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness~     of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy~     in patient with metastatic colorectal cancer. The primary objective of this study is to~     compare the functional vascular changes related to bevacizumab based chemotherapy and~     evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary~     objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the~     pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases~     evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships~     between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the~     bevacizumab.~   "
234256|NCT00489684|"~     The study is a multi-modal multi-tissue human experimental pain study in 24 healthy~     volunteers. The study is a randomized cross-over study. The effect of 2 opioids will be~     compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin~     and oesophagus, to sensitize these tissues. The pain thresholds before and after opioid~     administration will be compared. The hypothesis is that the difference in effect of the~     opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common~     phenomenon the clinic, the findings in this study may lead to a better understanding of the~     treatment of pain. The study will include an explorative study of the effect of Morphine of~     pain processing in the brain, this will provide us with new insight in the effect of the~     opioids of pain processing in the brain.~   "
234257|NCT00489671|"~     RATIONALE: Measuring cadmium levels in urine samples from patients with chronic pancreatitis~     may help doctors predict which patients may develop pancreatic cancer. It may also help the~     study of cancer in the future.~      PURPOSE: This clinical trial is studying urine cadmium levels in predicting pancreatic cancer~     risk in patients with chronic pancreatitis.~   "
234258|NCT00489658|"~     This case series study follows on a terminated randomised clinical trial in a nearby location~     of Uganda, in which the combination of eflornithine + nifurtimox showed very promising~     efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this~     combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness)~     patients.~   "
234259|NCT00489645|"~     • To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric~     emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated~     with subcutaneous (SC) injections of pramlintide.~   "
234260|NCT00489632|"~     Overall Objective:~      The overall objective of this cross-sectional psychosocial study is to examine~     illness-related factors, family context factors, and child resiliency as predictors or~     correlates of child adjustment to leukemia treatment.~      Primary Objective 1:~      1(a): To examine illness-related factors (i.e., child's health and physical functioning and~     severity of the child's illness) as predictors of child psychological adjustment to leukemia.~      1(b): To examine relapse status as a grouping variable affecting child psychological~     adjustment to leukemia.~      1(c): To examine stage of treatment as a grouping variable affecting child psychological~     adjustment to leukemia.~      Primary Objective 2:~      -To examine family context factors (i.e., family psychosocial risk and parental emotional~     distress) as correlates of child psychosocial adjustment to leukemia treatment.~      Primary Objective 3:~      -To examine child resiliency as a predictor of child psychological adjustment to leukemia~     treatment.~      Secondary Objectives:~        -  One secondary objective of the study is to examine parental distress as a moderator~          affecting parental report of child adjustment to leukemia as compared to the child's~          self-report of adjustment.~        -  Another secondary objective of the study is to develop a model by which the relative~          contribution of each predictor variable (as determined by analyses of primary~          objectives) as well as their interrelatedness can be understood in relation to child~          psychosocial adjustment.~        -  A third secondary objective of the study is to examine demographic variables as~          covariates in the main analyses. These variables include: age, grade, site, gender,~          ethnicity, type of leukemia, staging, time spent in treatment, age at diagnosis, and~          whether the child is undergoing standard or experimental treatment.~   "
234261|NCT00489619|"~     Malaria and sexually transmitted infections (STIs) are common in pregnant women in Africa and~     are important preventable causes of poor birth outcomes and maternal and infant mortality.~     This study investigated baseline characteristics of the population including: rates of STIs~     including HIV, prevalence of malaria and tuberculosis (TB) and resistance to common~     antimalarial drugs.~   "
234262|NCT00489606|"~     To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and~     tamsulosin, phase I study in healthy volunteers was designed.~   "
234417|NCT00487552|"~     The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used~     to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring~     treatment of gastric outlet obstruction caused by malignancy.~   "
234264|NCT00489580|"~     Study Objectives:~        1. To document the safe and effective application of the F.T.M. Arm Training Program using~          the SaeboFlex to an inpatient post stroke rehabilitation population.~        2. To compare functional improvements in hand and UE use achieved with the F.T.M. program~          as compared to generally applied therapeutic treatment approaches.~        3. To develop recommendations for an inpatient retraining protocol that could then be~          evaluated in a multi-center trial.~        4. To document the retention of UE and hand improvements after SaeboFlex training is~          discontinued as well as the carry over of these gains into daily function after therapy~          has been discontinued.~   "
234265|NCT00489567|"~     This study aims to estimate the burden of RV GE. The study will focus on children~     hospitalized for severe RV GE, Children acquiring RV GE in the hospital and the household~     contacts of children hospitalized with RV GE. It is expected to enrol 500-600 subjects in the~     study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,~     Sep 2007.~   "
234266|NCT00489554|"~     The purpose of this study is to assess the immunogenicity in terms of antibody response and~     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse~     events following primary vaccination of Mexican infants with pneumococcal conjugate vaccine~     GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined~     vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months~     of age.~   "
234267|NCT00489541|"~     The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the safety and efficacy of~     the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS®~     ElementTM) for the treatment of de novo atherosclerotic lesions of up to 20 mm in length in~     native coronary arteries of ≥ 2.25 mm to < 2.75 mm diameter.~   "
234268|NCT00489528|"~     The purpose of this study is to compare physical function and lean body mass in patients~     getting different doses of somatropin compared to patients not getting the drug.~   "
234269|NCT00489515|"~     RATIONALE: Diagnostic procedures, such as visceral lymphatic mapping using isosulfan blue,~     may help find cancer of the pancreas, colon, stomach, small intestine, or gallbladder and~     find out how far the disease has spread.~      PURPOSE: This clinical trial is studying the side effects and how well visceral lymphatic~     mapping using isosulfan blue works in patients with cancer of the pancreas, colon, stomach,~     small intestine, or gallbladder.~   "
234270|NCT00489502|"~     Due to common CVD diseases associated from obesity, medical providers are in a position to~     provide assistance. However, less than 10% of all patients receive any weight loss advice~     from physicians. Perceived barriers to weight loss counseling include lack of self-control of~     their patients and belief that recommendation is futile, lack of medical training in~     nutrition, exercise, and obesity management, and lack of insurance reimbursement. Though many~     barriers are prevalent, research has demonstrated a positive effect with medical advice on~     the number of obese individuals attempting to lose weight. Analyzing data from the 1996~     Behavioral Risk Factor Surveillance System, researchers found, when advised to lose weight by~     a physician, 78% of overweight patients reported attempting to lose weight. However, if their~     physician did not discuss weight loss, only 33% of patients within the same BMI category~     attempted to do so 7. From this information, physicians or allied health staff that provide~     brief counseling (5-10 minute) along with medical technology that provides basic nutrition~     assessment might have a positive impact on the number CVD patients that are obese attempting~     to lose weight.~      HYPOTHESIS: Will a medical specialty clinic focused on cardiovascular medicine successfully~     be able to implement the MedGem device for assessment of basic nutritional needs along with~     providing “brief” patient education into the medical practice without a house dietitian.~      PRIMARY AIMS~        1. Can medical staff and/or support staff provide REE assessments (15-minutes) and brief~          patient education (5-15 minutes) as part of the clinic’s operations?~        2. Will a third-party payer compensate the Medical Specialty Clinic for the diagnostic~          procedure CPT Code 94690 for obese patients diagnosed with hypertension (401.1-9,~          402.10-11, & 402.90-91), hypercholesterolemia (272.1), and/or hyperlipdemia (272.2)?~      SECONDARY AIMS~        1. Does self-efficacy increase from REE assessments?~        2. Do patients adopt healthy eating (Calorie Reduction and Fat Reduction)following REE~          assessments?~   "
234271|NCT00489489|"~     The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide~     administered once daily for 24 weeks, compared with placebo, in patients with multiple~     sclerosis [MS] with relapses who were on a stable dose of interferon-β [IFN-β].~      Secondary objectives were:~        -  to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in~          combination with a stable dose of IFN-β on Magnetic Resonance Imaging [MRI] parameters,~          relapse rate and patient-reported fatigue;~        -  to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with~          a stable dose of IFN-β.~   "
234272|NCT00489476|"~     The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in~     patients with migraine headache with or without aura in a clinical setting.~   "
234273|NCT00489463|"~     The aim of this study was to evaluate the effect of the LNG-IUS and TCU 380A users on the~     sub-endometrial vascularization and the uterine artery blood flow using power Doppler~     analysis and ultrasonography pulsed color Doppler during the precise mid-luteal phase.~   "
234274|NCT00489450|"~     This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics~     (PKs) and safety.~   "
234275|NCT00489437|"~     Main Research Question:~      Can two new types of test, one called the 4T's score and the other called a rapid assay, help~     doctors correctly identify which patients are unlikely to have heparin-induced~     thrombocytopenia (HIT)?~      HIT is a severe allergic reaction to the blood thinner heparin. This allergic reaction can~     lead to heart attacks, strokes, limb amputations, and death. Because heparin is one of the~     most commonly used drugs in the hospital setting, it is very important that the investigators~     are able to correctly identify who can safely continue to take heparin and who cannot.~      It can be very difficult to diagnose HIT because it can look like many other medical~     conditions and the best laboratory tests for HIT are difficult to run and only available at~     specialized centres.~      It would be very helpful if doctors had tests they could use that would tell them quickly and~     accurately which patients with symptoms that look like HIT really do have HIT (and require~     urgent treatment with another type of blood thinner) and which patients are very unlikely to~     have HIT (and could continue to take heparin safely). In this study, the investigators will~     compare the 4T's score (a scoring system that assigns points to the presence or absence of~     specific clinical features) and a rapid laboratory test with the old laboratory test to find~     out if one or both of these types of tests are useful for telling doctors which patients have~     HIT and which patients don't have HIT.~   "
234276|NCT00489424|"~     This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of~     occurrence and the severity of post dose symptoms that may occur during the 3 day period~     following a zoledronic acid infusion in post menopausal women with low bone mass.~   "
234279|NCT00489385|"~     This study will determine if Albumin-linked interferon (Albinterferon alfa-2b) every 2 weeks~     is safe and tolerated by patients infected by both hepatitis C virus (HCV) and human~     immunodeficiency virus (HIV). This is a new medication developed for HCV. It may help the~     immune system fight infections, especially those caused by viruses. Albinterferon alfa-2b~     appears quite similar to other interferons, in side effects and action in controlling HCV.~      Patients ages 18 and older who are infected with HCV genotype 1, are HIV positive, are~     infected with HCV, and have evidence of HCV-induced liver disease; and who are not pregnant~     or breast feeding may be eligible for this study. Many visits to NIH over a 76-week period~     are required. There will be collection of blood and urine, pregnancy test, and tests of HCV~     in the blood. A liver biopsy is required before start of the study if patients have not had~     one within 1 year. Another is done at the end of 72 weeks. An eye exam is done before start~     of the study and repeated later. An optional procedure called automated pheresis is done at~     the study beginning. Researchers can study patients' immunity to control HCV. Blood is drawn~     through a needle in an arm vein and spun in a machine to separate the desired blood~     component. Remaining blood is returned to the patient.~      Patients will receive Albinterferon alfa-2b at a dose of 900 mcg every 2 weeks for 48 weeks,~     by injection under the skin. Ribavirin is given at 1,000 mg or 1,200 mg by mouth twice daily,~     depending on a patient's weight. Side effects of Albinterferon alfa-2b are fatigue, headache,~     joint and muscle pain, and sleeplessness. The major side effect of ribavirin is anemia.~     Visits ranging from week 3 to 44 will determine the safety of Albinterferon alfa-2b and~     ribavirin and to see effects on reducing the HCV viral load. For weeks 48, 52, 56, 64, 72,~     and 76, patients will return for a clinic visit and blood tests. At week 72, an abdominal~     ultrasound and liver biopsy are done. Week 76 includes discussion of biopsy results.~   "
234280|NCT00489372|"~     This randomized phase I trial is studying the side effects and best dose of~     Se-methyl-seleno-L-cysteine in healthy adult men. Studying samples of blood, urine, and~     toenail clippings in the laboratory from healthy men receiving Se-methyl-seleno-L-cysteine~     may help doctors learn more about how Se-methyl-seleno-L-cysteine works in the body.~   "
234281|NCT00489359|"~     The purpose of this study is to determine efficacy of the combination therapy of pemetrexed~     and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study~     also includes patients with primary peritoneal cancer.~   "
234282|NCT00489346|"~     A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent~     asthma.~   "
234283|NCT00489333|"~     The purpose of this study is to compare the effects of supplementation with ProAlgaZyme (a~     novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome~     and indicators of cardiovascular health including: body weight and fat, blood lipids,~     inflammatory markers such as hsCRP, blood pressure and fasting blood glucose.~   "
234284|NCT00489320|"~     The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES)~     in patients in a real-world setting. The stents being observed are not investigational, that~     is, they have been approved for use in the general population.~   "
234285|NCT00489307|"~     The goal of this clinical research study is to learn if dexamethasone can help to control~     symptoms such as fatigue, pain, nausea, weight loss, loss of appetite, sleep problems, and/or~     depression in patients with advanced cancer.~   "
234286|NCT00489294|"~     The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth~     hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.~   "
234287|NCT00489281|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and~     total-body irradiation before a donor bone marrow transplant helps stop the growth of~     abnormal cells. It also helps stop the patient's immune system from rejecting the donor's~     stem cells. When the healthy stem cells from a donor are infused into the patient they may~     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells. Giving sirolimus and mycophenolate mofetil after transplant may stop~     this from happening.~      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide~     together with total-body irradiation followed by a donor bone marrow transplant works in~     treating patients with sickle cell anemia and other blood disorders.~   "
234288|NCT00489268|"~     This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to~     evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy~     density (J/cm2) to barrett's tissue. The dosimetry phase evaluated the dose-response and the~     safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 delivered twice for~     all patients, followed by Esophagogastroduodenoscopy (EGD) with biopsies at 1, 3, 6, and 12~     months. A second ablation procedure was performed if Barretts esophagus (BE) was present at 1~     or 3 months. A complete response (CR) was defined as all biopsy specimens negative for~     Barrett's Esophagus at 12 months. The effectiveness phase of the present study was extended~     to a 2.5-year follow-up. This trial incorporated an opportunity for persistent BE to be~     treated with a focal ablation device (HALO90), achieving a CR in 98.4% of patients by the~     2.5-year follow-up,the results of which were published . There is ample evidence that~     RadioFrequency Ablation (RFA) for Barrett's esophagus is effective and safe. Having~     additional follow-up (5 years) would add valuable information to the literature, thus aiding~     the physician in making patient management decisions about the appropriate follow-up interval~     after RFA.~   "
234289|NCT00489255|"~     The purposes of the study are to determine:~      i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting~     when initiating therapy with Apokyn® (apomorphine)~      ii. To determine the optimal duration for continuation of Tigan® following initiation of~     Apokyn® therapy~      iii. To assess the safety of Tigan® in combination with Apokyn®~      iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated~     concomitantly with and without Tigan®~   "
234290|NCT00489242|"~     Aims of this study will be to assess the difference in CFV/CFR (Coronary flow~     velocity/reserve) in diabetic vs. non-diabetic patients and to correlate CK-MB, TnI and HsCRP~     release after otherwise successful coronary stenting.~   "
234291|NCT00489229|"~     The aim is to examine whether pharmacological interventions with thiazolidinedione and~     angiotensin converting enzyme (ACE) inhibitors can reverse pre-clinical vasculopathy in newly~     diagnosed diabetic and IGT individuals.~   "
234292|NCT00489216|"~     RATIONALE: Efalizumab may be an effective treatment for graft-versus-host disease of the skin~     caused by a donor stem cell transplant.~      PURPOSE: This clinical trial is studying the side effects and how well efalizumab works in~     treating patients with graft-versus-host disease of the skin that did not respond to previous~     steroids.~   "
234418|NCT00487539|"~     The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148)~     therapy in participants with ulcerative colitis (UC).~   "
234419|NCT00487526|"~     Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes.~   "
234293|NCT00489203|"~     RATIONALE: Beclomethasone dipropionate may be effective in preventing acute graft-versus-host~     disease in patients undergoing a stem cell transplant for hematologic cancer.~      PURPOSE: This randomized phase II trial is studying how well beclomethasone dipropionate~     works in preventing acute graft-versus-host disease in patients undergoing a donor stem cell~     transplant for hematologic cancer.~   "
234294|NCT00489190|"~     To collect effectiveness and safety data during the treatment with Apidra glulisine (HMR1964)~     by means of subcutaneous injections to patients with Diabetes Mellitus 1st type during 12~     weeks-active phase.~   "
234295|NCT00489177|"~     This international study is assessing if repeat adjustment of the timing between the three~     leads in a cardiac resynchronization therapy (CRT) defibrillator will increase the likelihood~     of benefit (symptoms and heart function) compared to usual device programming. The hypothesis~     is that QuickOpt facilitated serial optimization of sensed atrioventricular (sAV), paced~     atrioventricular (pAV), and inter-ventricular (VV) timing in the initial 9 months following~     successful CRT will increase the rate of clinical response and structural remodeling at 12~     months compared to usual care.~   "
234296|NCT00489164|"~     The main objective of this study is to assess in-stent late lumen loss in diabetic patients~     with de novo native coronary lesions using the sirolimus-eluting Bx VELOCITYä stent as~     compared to the Bx VELOCITY balloon-expandable stent.~   "
234297|NCT00489151|"~     Liver diseases due to hepatitis B reactivation are serious causes of morbidity and mortality~     in hepatitis B infected patients treated with chemotherapy. We have previously shown that~     with pre-emptive use of lamivudine, one can drastically reduce liver-related morbidity and~     mortality in such patients. However, due to the development of hepatitis B virus resistance~     to lamivudine, some of these hepatitis B infected patients still develop hepatitis. This is a~     research study aiming to compare the use of adefovir dipivoxil to lamivudine in hepatitis B~     infected patients treated with chemotherapy. Both of these drugs have been approved for the~     treatment of the hepatitis B infection in the United States, European Union and Hong Kong.~      All patients who were recruited in this study will receive study medication, either~     lamivudine 100 mg daily or adefovir dipivoxil 10 mg daily to cover the entire period of~     chemotherapy for 72 weeks. All patients will be follow-up for an additional 24 weeks~     thereafter. Altogether, 70 subjects will be recruited from Queen Mary Hospital, Hong Kong~     SAR.~      This is an open-label study, which means that the patients and the study doctor will know~     which treatment the subjects are assigned into. If a subject decides to take part in the~     study and is found eligible, he/she will be randomly (like flipping of coin) assigned to one~     of the following dose groups:~      Lamivudine (100 mg) tablet Adefovir dipivoxil (10 mg) tablet~   "
234298|NCT00489138|"~     Goal of study:~      To assess the tissular and plasma kinetics of ertapenem;~      To determine the optimal dosages in the patients according to norepinephrine administration:~        -  to assess muscular diffusion of free form of ertapenem after administration to~          mechanically ventilated patients requiring such a treatment. The patients are included~          in the groups with norepinephrine or without norepinephrine according to their~          hemodynamic status.~        -  to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients~          treated or not by norepinephrine.~      Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700~     beds).~   "
234299|NCT00489125|"~     RATIONALE: Gathering information about strength and range of motion over time from women~     undergoing surgery for breast cancer may help doctors learn more about recovery from surgery~     and on-going care.~      PURPOSE: This clinical trial is collecting information about strength and range of motion~     over time from women undergoing surgery for breast cancer.~   "
234300|NCT00489112|"~     We will performe a prospective randomized study to evaluate the effects of the addition of~     alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A~     total of 60 patients with distal ureteral calculi will randomly divide into two treatment~     groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m.~     75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for~     a maximum of 2 weeks.No significant differences will be between the groups for age, gender~     distribution and mean stone size measured in the single largest dimension at~     presentation.Randomization will be done only with the patients permission after they had read~     a summary describing the goals of conservative management and a description of the drugs they~     would be taking. Potential side effects and complications of the drugs were discussed. The~     expulsion rate will the primary end-point of this study.~   "
234301|NCT00489099|"~     A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B~     vaccine manufactured using an upgrade to the production process. The primary hypotheses~     tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the~     process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen~     (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection~     to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to~     HBsAg that are non-inferior or superior to those induced by the current process vaccine.~   "
234302|NCT00489086|"~     RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in~     treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.~   "
234303|NCT00489073|"~     The primary purpose of this study is to determine if duloxetine reduces pain severity in~     patients with fibromyalgia.~   "
234304|NCT00489060|"~     A trial to determine if cryoablation is as effective as radiation in the treatment of men~     with localized prostate cancer.~   "
234305|NCT00489034|"~     The proposed multi-site, longitudinal study will examine the correlation of substance use,~     mental health disorders, and social networks to engagement in care for HIV-infected~     adolescent females, aged 13 years, 0 months - 23 years, 11 months, and suggest ways to~     promote adherence and retention in treatment, care, and prevention programs. Qualitative and~     quantitative data collection methods will be used with index participants and network~     members.~   "
234420|NCT00487513|"~     In order to learn more about follicular lymphoma and anti-cancer vaccines, we are collecting~     samples from people with this diagnosis. We then hope to make a vaccine from this tissue to~     help the immune system destroy cancer cells. We plan on keeping samples in the tissue bank~     indefinitely.~   "
234306|NCT00489021|"~     Hospitalization is a traumatic event for the patient and his family at any age nevertheless~     in the older age. One of its consequences is the difficulty to resume previous activity of~     daily living especially in older (over 75 years) patients. Sub acute completes the acute~     phase of the hospitalization and its main purpose is to improve the patient's functional~     status and quality of life. There are not enough clinical trails to proof this assumption.~     The purpose of our study is to compare the outcome of acute and sub-acute hospitalization~     programs by a randomized controlled prospective intervention study. Outcome measures will~     comprise activity of daily living, functional status, re-hospitalization and utilization of~     medical services following the hospitalization.Study hypothesis is that sub-acute~     hospitalization will improve outcomes and will cost less.~   "
234307|NCT00489008|"~     The goal of this clinical research study is to learn if stereotactic body radiotherapy (SBRT)~     can help to control NSCLC. The safety of SBRT will also be studied.~      Objectives:~      To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy (SBRT) for~     patients with medically inoperable stage I (T1-2, N0,M0), selective stage II (chest wall T3,~     N0M0) or isolated peripheral lung recurrent non-small cell lung cancer (NSCLC).~      Primary goal: Improve 2 years progression free survival at the treated primary tumor site.~      Secondary goals:~        1. Improve disease free survival, disease specific survival and overall survival at 2~          years.~        2. Decrease grade 3 and above acute and/or chronic toxicities.~        3. Collect blood for future biomarkers study~   "
234308|NCT00488995|"~     The purpose of this study is to determine if CP-675,206, a monoclonal antibody to CTLA4, is~     safe and well-tolerated, reduces viral load, and improves immune function in patients~     infected with HIV.~   "
234309|NCT00488982|"~     This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without~     GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each~     cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy,~     eligible subjects will be randomized to no maintenance therapy or to maintenance GM-CSF~     therapy. The GM-CSF group dose schedule will be 250 mcg/m2 SQ daily Days 15-28 every 28 days.~     Patients in both groups will continue until disease progression at which time GM-CSF will be~     discontinued and chemotherapy will again be administered.~   "
234310|NCT00488969|"~     We would like to learn if a medicine called modified-release morphine sulfate (Avinza)~     helps reduce Spinal Cord Injury (SCI)-related pain that has lasted a long time.~     Modified-release means that the medicine in the capsules is slowly released to the body,~     instead of being released all at once. Avinza is approved by the Food and Drug Administration~     for the treatment of pain, but we do not know how effective Avinza is in reducing SCI-related~     pain.~   "
234311|NCT00488956|"~     Some women develop swollen feet and ankles after a cesarean delivery. These women will often~     complain that their shoes are too tight and their feet may become numb or they may have some~     tingling in their feet.~      Currently we do not know for sure that foot swelling occurs after a cesarean delivery and if~     it does what the cause is.~      If we find that feet do swell after a cesarean delivery we may be able to suggest a cause.~     This may in the future prevent women developing excessive foot swelling.~      We aim to investigate whether the size and shape of women's ankles do change following an~     elective cesarean delivery. We plan to investigate, if possible, the cause of any foot~     swelling after a cesarean whether it be the volume of intra venous fluids or oxytocin use.~   "
234312|NCT00488943|"~     To collect and analyze clinical follow-up data which can be used to assess the safety,~     efficacy, and durability of endovascular AAA repair with Zenith and Chuter-Gianturco~     stent-grafts.~   "
234313|NCT00488930|"~     A research study to find out more about a specific white blood cell called a dendritic cell.~     These cells are found in a layer of fat in the body called the omentum. The omentum is a~     layer of fat that covers the bowels (intestines) and protects them.~      The purpose of this study is to allow us to compare dendritic cells in normal weight~     individuals to the dendritic cells of people who are extremely overweight. These cells will~     be collected from the omentum, the layer of fat that covers and protects the bowels~     (intestines), from the mesentery, which is another layer of fat that surrounds the intestines~     directly, and from the subcutaneous tissue, which is the layer of fat just under the skin.~   "
234314|NCT00488917|"~     The purpose of the study is to determine the role of new biomarkers in the diagnosis of~     sepsis in critically-ill patients with liver failure and to correlate the prognosis of these~     patients with parameters of endothelial function and lipid metabolism.~   "
234315|NCT00488904|"~     To discover whether an Omega-3 fatty acid (eicosapentaenoic acid/EPA and~     docosahexaensyre/DHA) enriched nutritional supplement given 7 days preoperatively and 7 days~     postoperatively may reduce the frequency of postoperative infectious complications defined~     as: pneumonia, wound infection, urinary tract infection, peritonitis (including anastomotic~     leakage) and septic conditions of any cause in patients who undergo elective operations for~     colorectal cancer compared with a nutritional preparation that is identical apart from the~     EPA content.~   "
234316|NCT00488891|"~     The purpose of this study is to examine the long-term economic, functional and clinical~     outcomes in schizophrenia patients who require a change in antipsychotic treatment, and are~     changed to either paliperidone extended release (ER) or another oral atypical antipsychotic~     agent (AAP) including aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone.~   "
234317|NCT00488878|"~     The goal of this psychosocial research study is to collect information on patients with one~     of the above-mentioned low-grade tumors. Researchers want to maintain these patients'~     information in a research database to help learn and better understand these tumor types and~     to help develop better treatments for them.~      This is an investigational study. There will be no cost for participating in this research~     study. Up to 2000 patients from MD Anderson will take part in this study.~   "
234318|NCT00488865|"~     This study is designed to evaluate the safety and efficacy of the RexMedical Option* Vena~     Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and~     require caval interruption.~   "
234319|NCT00488839|"~     The purpose of this study is to determine the effects, both good and bad, of IPX056 on~     subjects and their spasticity. This study will also determine the relationship between the~     amount of IPX056 in blood and the effects on spasticity. Lastly, this study will determine~     how long IPX056 affects spasticity.~   "
234320|NCT00488826|"~     This study is a combination of a Phase I and Phase III study design. The Phase I portion is~     an open-label, controlled study to evaluate the safety of 7vPnC in healthy Chinese infants.~     The Phase III portion is an open-label, controlled, randomized study to evaluate the safety~     and immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)in healthy Chinese~     infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and~     /or Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) at about 3, 4, and 5~     months of age; and a Booster Dose which includes the 4th dose of 7vPnC at 12-15 months of~     age.~   "
234321|NCT00488813|"~     A single-center, prospective, comparative, antibiotic intervention study for patients~     admitted to MICU1 and MICU2~   "
234322|NCT00488800|"~     This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian~     children.~      Prevenar is indicated for active immunization of infants and children from 6 weeks of age~     through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia,~     bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and~     23F.~      Prevenar has been marketed in India since June 2006. The Board of Health in India has given~     restricted permission to import and market Prevenar. The present study is a post-approval~     regulatory commitment to the Board of Health in India.~      This is an observational study and the protocol for the study has been approved by the Board~     of Health.~   "
234323|NCT00488787|"~     Once patients' postoperative pain intensity reaches a moderate-to-severe level, they are~     randomized to receive intranasal ketamine or placebo. Patients remain in the study unit for 3~     hours post administration and assess pain intensity and pain relief throughout the 3 hour~     postoperative period.~   "
234324|NCT00488774|"~     The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148)~     therapy in participants with active ulcerative colitis (UC) (sores in the colon).~   "
234325|NCT00488761|"~     Tigecycline's activity against resistant organisms, as well as significant coverage of both~     gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in~     treating patients with complicated skin and/or skin structure infections.~   "
234326|NCT00488748|"~     This study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy~     (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major~     depressive episode in the context of either unipolar or bipolar depression. The investigators~     will conduct a number of clinical and neuropsychological tests to assess clinical and~     cognitive response to treatment. The investigators hypothesize that:~        1. MST and ECT will have similar antidepressant efficacy.~        2. MST will have less post-treatment amnesia than ECT as reflected in primary measures of~          anterograde and retrograde amnesia following the acute treatment phase.~        3. At follow up, MST will show a lesser degree of persisting deficit in measures of~          retrograde amnesia than ECT.~   "
234327|NCT00488735|"~     BACKGROUND~      Non-specific back and neck pain (BNP) dominates sick-listing. A program of~     cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month~     follow-up, with traditional primary care concerning sick-listing and health-care visits.~      METHODS~      After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (=~     full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were~     randomized to a rehabilitation center or continued health-center care. Outcome measures were~     Return-to-work (=the proportion who regained work ability for at least 30 consecutive days),~     the proportion with Work ability at different time points, Total sick-listing (expressed in~     whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months~     and corresponding six-month periods. For the analyses were used t-test, z-test, generalized~     estimating equations and a mixed, linear model.~   "
234328|NCT00488722|"~     It has been found that many breast cancers are hormone dependent and that hormonal therapy by~     estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has proven~     beneficial in both adjuvant and neoadjuvant settings. Zoladex, a kind of luitinizing hormone~     releasing hormone analogue, can offer efficient estrogen suppression as well. It can induce~     reversible amenorrhea and the clinical effect is similar to ovarian ablation. Some studies~     have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone~     dependent breast cancer in both adjuvant and metastatic settings. Few data is available on~     Zoladex in neoadjuvant treatment for breast cancer In our departments, neoadjuvant CEF~     regimen is of general practice, and a preliminary study is designed to investigate whether~     adding Zoladex into neoadjuvant CEF could further improve results in hormone responsive~     breast cancer.~   "
234329|NCT00488709|"~     The study is designed with drugs used frequently in the treatment of AML, but with a new~     combination less toxic,and effective in AML multidrug resistant.~      Justification:~        -  The AML patients with primary resistance or relapsed in the first 12 months after CR,~          have second line chemotherapy low response rate .~        -  These patients with AML with primary resistance or relapse, that reach remission after a~          rescue treatment, have an interval free survival and a global survival very short~        -  Probably the resistance to the treatments is in relation to different forms expression~          of the MDR.~        -  Complete remission is considered valid evaluation, because every patient who should~          obtain a CR can be considered to be eligible for a possible curative treatment: Ara-C~          administration to high doses or the TPH treatment~   "
234330|NCT00488696|"~     This is a study to assess the safety and effectiveness of endovascular treatment of aortic~     aneurysms involving the proximal aortic arch. The investigational operation involves placing~     a stent-graft over the aortic aneurysm.~   "
234331|NCT00488683|"~     This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135~     and Y specific memory B Cells, measured 1 month after a primary vaccination series of~     Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human~     complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age~   "
234332|NCT00488670|"~     To investigate the effect of Escitalopram in a large and diverse of dementia patients~     suffering from depression.~   "
234421|NCT00487500|"~     This study will compare four types of electroconvulsive therapy to determine if they differ~     in their effects on mood, thinking, brain activity, and biochemistry in people with major~     depressive disorder.~   "
234333|NCT00488657|"~     This project will systematically examine the therapeutic effect of altered auditory feedback~     provided by the in-the-ear device on the speech impairments in patients with Parkinson's~     disease.~      Many patients with PD have difficulty starting their speech even though they know the words~     they want to say. They experience 'freezing' of the jaw, tongue and lips. When they~     eventually get their speech started, they have a hard time moving it forward. They keep on~     saying the same words or phrases over and over again while their voice gets softer and~     softer. Many words also run together. These symptoms make patients' speech very hard to~     understand and directly affect their care and quality of life. Currently, there is no~     effective medical or surgical treatment for these speech symptoms.~      We have tested an in-the-ear therapeutic device that provides altered auditory feedback in~     eight patients with PD and moderate to severe speech impairment and the results are~     encouraging. We will recruit 100 patients with PD and moderate to severe speech impairment~     for Phase A and 20 for Phase B of the study. They will use the device routinely to provide~     the altered auditory feedback as they speak to improve their speech intelligibility.~   "
234334|NCT00488644|"~     Primary Objectives:~        1. Assess whether combined treatment with Levothyroxine and Liothyronine improves learning~          and memory.~        2. Explore the relationship between T3 treatment and other domains of cognitive function,~          quality of life, and mood.~   "
234335|NCT00488631|"~     The purpose of this study is to assess the safety and efficacy of golimumab administered~     subcutaneously (under the skin) injections in maintenance therapy.~   "
234336|NCT00488618|"~     This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188~     monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks~     double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility~     criteria will be randomized to one of two treatment groups: RGH-188 or placebo~   "
234337|NCT00488605|"~     LCH III is an international, multicentric, prospective clinical study comprised of:~        -  a randomized clinical trial for multisystem RISK patients and~        -  a randomized clinical trial for multisystem LOW RISK patients and~        -  a pilot study for patients with single system MFB and localized SPECIAL SITES~   "
234338|NCT00488592|"~     This study will test the safety and effectiveness of two vaccines on slowing disease~     progression, improving blood counts, reducing the need for transfusions of blood and~     platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known~     as myelodysplasia), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). The~     vaccines consist of peptides (parts of proteins) found in MDS, AML and CML stem cells,~     combined with a substance called MontanideTM. They are administered with granulocyte-~     macrophage colony- stimulating factor (GM-CSF). The Montanide and the GM-CSF help the immune~     system respond to the vaccines.~      People 18 years of age or older with MDS, AML or CML may be eligible for this study.~      Participants receive six injections of the vaccines, one dose every other week for a total of~     10 weeks. The injections are given in the upper arm, upper leg, or abdomen. A separate~     injection of GM-CSF is given in the same area as the vaccine injections. Subjects are~     observed for 2 hours after the first vaccination and at least 30 minutes after each~     subsequent vaccination for allergic reactions. In addition to the vaccination, subjects~     undergo the following:~        -  History and physical exam, chest x-ray, blood tests and bone marrow aspirate and biopsy~          before starting the vaccinations.~        -  Safety monitoring during vaccine administration (every other week for 10 weeks) with~          blood tests and check of vital signs.~        -  Follow-up safety monitoring (weeks 12 and 16) with blood tests every visit, chest x-ray~          at week 12 and bone marrow biopsy visit 16.~   "
234339|NCT00488579|"~     Comparison of two policies of iron administration during pregnancy in regard to health and~     program feasibility in an area with endemic malaria and high prevalence of HIV infection. The~     policies are: 1) routine iron prophylaxis, 2) screening and therapy with iron.~   "
234340|NCT00488566|"~     This is a First Time in Human Study to assess the safety, tolerability, pharmacokinetics and~     resting motor threshold (rMT) of single doses of GSK drug in healthy volunteers.This will be~     a 2 part and 2 centre study.Part 1 will be a double-blind, randomized, placebo-controlled,~     single oral dose, dose-rising, cross-over study in healthy male and female (of non-child~     bearing potential) volunteers.Subjects will be randomized into cohorts of 10 subjects and~     cohorts will be recruited until the pre-defined safety or PK stopping limits are reached.Each~     subject will receive placebo and no more than 4 ascending doses of GSK drug in a randomized~     sequence on 5 separate study occasions.Each dosing session will take place over 2 days and~     there will be at least one subject on placebo on each day. There will be only one subject on~     any new active dose during the first day.Part 2 will be a randomised, double-blind,~     double-dummy, placebo-controlled, cross-over study to investigate the effect of single doses~     of GSK drug and lamotrigine on resting motor threshold in healthy male subjects. Subjects~     will attend the unit a maximum of 4 separate occasions.During each session subjects will~     receive up to 4 TMS measurements and single doses of either GSK drug, lamotrigine or placebo,~     in a randomised manner.Up to two doses of GSK drug will be investigated.~   "
234341|NCT00488553|"~     Primary Objectives:~        1. To enroll and obtain, through questionnaires, risk factor information on all study~          participants to develop detailed demographic, epidemiologic and behavioral profiles.~        2. To assess the influence of relevant epidemiologic covariates such as age, gender,~          smoking and family history of cancer on the panel of susceptibility biomarkers.~        3. To evaluate the role of genomic instability in development of lymphomas.~   "
234342|NCT00488540|"~     There are many reasons for using a vacuum apparatus or forceps to assist in delivering a~     baby. The traction and pressure on the baby`s head due to the vacuum apparatus or forceps may~     cause pain and discomfort for some time after the delivery. To date, the pain experienced by~     the newborn and the potential beneficial effects of pain medications after vacuum or forceps~     deliveries have not been systematically studied. It is possible that administration of~     paracetamol suppositories to the newborn may be helpful in these situations, since this~     medication is known to ameliorate pain in older children and adults.~   "
234496|NCT00486525|"~     RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer~     survivors.~      PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving~     physical activity, inflammation, fatigue, and distress in female breast cancer survivors.~   "
234343|NCT00488527|"~     To evaluate the efficiency of Lantus plus combined oral hypoglycaemic agents in terms of~     respondents percentage. The respondent is defined as the person achieving a value in the~     final determination of HbA1c < 7% as its absolute value and/or a decreasing in the final~     value of HbA1c of more than 12% compared with the initial value (final HbA1c vs. initial~     HbA1c).~      Describe the glycemia levels and body weight change in the two response groups, (respondents~     and non-respondents).~      Describe the adverse events Evaluate the safety of using the medication according to the~     incidence and relevance of the hypoglycemia events, (symptomatic, diurnal, nocturnal,~     severe).~      Estimate the intra-patient variability of the fasting glycemia~   "
234344|NCT00488514|"~     This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen~     sodium) in adolescents for the acute treatment of migraine.~   "
234345|NCT00488501|"~     In this study we investigate the clinical value and efficacy of OptiVol (TM) impedance~     measurements by Medtronic (R) ICD's. We aim to determine sensitivity and positive predictive~     value for detecting heart failure. We also investigate if left ventricular filling pattern~     measured by echocardiography and/or brain natriuretic peptide (BNP) level can be used to~     improve the positive predictive value of the Optivol alert~   "
234346|NCT00488488|"~     To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main~     goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to~     assess the main side effects observed in daily medical practice (Safety of Tygacil); to~     determine whether patients are optimally dosed with Tygacil (according to the label) and the~     proportion of patients receiving a monotherapy versus combination therapy; to observe the~     potential resistance development against Tygacil in Germany; to determine which antibiotic~     agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic~     substance non-responders to Tygacil are switched; to assess the duration of the intravenous~     therapy with Tygacil and to determine whether and which patients receive an oral antibiotic~     substance after the therapy with Tygacil; to collect information on profile, comorbidities~     and characteristics of patients treated with Tygacil.~   "
234347|NCT00488475|"~     The diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo~     rapid change. Randomized controlled trials such as the TEMPO study have demonstrated the~     efficacy and safety of the combination of etanercept and methotrexate. Importantly, the TEMPO~     study showed that patients treated with etanercept and methotrexate could reach the newer~     therapeutic goals of low disease activity and remission, and that the physicians, patients,~     and payers are no longer prepared to accept the goal of Reduction of symptoms. RCT are~     important and powerful tools in assessing efficacy and safety but have their limitations in~     terms of generalisability. In order to assess health economics, clinical effectiveness and~     safety of etanercept, they need to be measured by performing observational studies of~     unselected patients. This study aims to provide a holistic assessment of patients receiving~     etanercept in a real world setting. This will include centers that would not normally take~     part in RCT. The study will assess treatment with etanercept with descriptive statistics of~     the following parameters: Health economic, Safety, Effectiveness. In addition, there was a~     previous study of similar design, but of only 3 months duration (101354), which will allow~     comparison with historical data. Since previous study, there have been a number of~     significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once~     weekly), Definition of early RA has been modified to short disease duration (from 3 months to~     1 year).~   "
234348|NCT00488462|"~     This trial will address the question of whether early application of the Non-pneumatic~     Anti-Shock Garment (NASG) at the Satellite Health Facility (SHF) level before transport to a~     Referral Hospital (RH) will decrease maternal mortality and morbidity. The available evidence~     indicates that the NASG substantially decreases blood loss, but there is no evidence that its~     application will reduce extreme adverse outcomes. It is also not known if possible side~     effects associated with NASG use might outweigh potential benefits. This study would~     rigorously test the effectiveness of the NASG using an experimental design with adequate~     power to detect statistically significant decreases in morbidity and mortality.~   "
234349|NCT00488449|"~     The purpose of this study is to compare the effects of single and repeat doses of GSK256073~     with placebo in HVT subjects.~   "
234350|NCT00488436|"~     The different mechanisms of action between Antithymocyte globulin and cyclosporine can~     improve the effectivity when both are used in combination in patients with myelodysplastic~     syndrome.~   "
234351|NCT00488423|"~     MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery.~     There are two different procedural tests involved; an oral glucose tolerance test (mixed~     meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more~     are performed postoperatively for a one year period. The associated labwork drawn with the~     mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone~     levels.~   "
234352|NCT00488410|"~     Patients showing a normal value of SDI (< or + 8%) will randomly be assigned to CRT in ON~     or OFFmode at one month after implantation. In any case of emergency, an automated rescue~     mode is included in the device for the patients in OFF mode.~   "
234353|NCT00488397|"~     In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.~   "
234354|NCT00488384|"~     Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous~     cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.~   "
234355|NCT00488371|"~     Primary Objective:~      To evaluate the impact of PCV7 vaccination on NP carriage rate of vaccine serotypes and~     serotype distribution~      Secondary Objective:~      To evaluate the impact of PCV7 vaccination on NP carriage of antibiotic resistant pneumococci~     and serotype distribution.~   "
234356|NCT00488358|"~     To compare the aortic pulse profile before and after stent-graft implantation to prove that~     endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.~   "
234357|NCT00488345|"~     To determine the pharmacokinetic profile and to evaluate the safety and tolerability of~     ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious~     infections; complicated intra-abdominal infections (cIAI), complicated skin and skin~     structure infections (cSSSI), or community-acquired pneumonia (CAP).~   "
249459|NCT00287261|"~     In this trial, the question is addressed if zoledronic acid (Zometa, Novartis Pharma)could be~     of clinical benefit for patients with myelofibrosis and myeloid metaplasia (MMM).~   "
234358|NCT00488332|"~     Objectives:~        1. To assess the tolerability of performing optical coherence tomography and/or optical~          spectroscopy in patients with acute oral mucositis.~        2. To determine the feasibility of obtaining optical coherence tomography images and/or~          fluorescence excitation emission matrices from normal and affected sites in patients~          with acute oral mucositis.~        3. To compare optical data obtained with optical coherence tomography and/or spectroscopy~          with the clinical appearance and scoring of oral mucositis lesions.~   "
234359|NCT00488319|"~     The purpose of this open-label study is to evaluate the long-term (6-month) safety and~     tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible~     dosages to adolescents with schizophrenia.~   "
234360|NCT00488306|"~     In light of tigecycline's activity against these resistant bacteria, tigecycline may~     represent a viable new therapy for complicated intra-abdominal infections.~   "
234361|NCT00488293|"~     This study compares store and forward teledermatology with the conventional clinic-based~     consult process. Our primary objective is to determine whether the mean change in quality of~     life, as rated by the subscale scores and composite score on the Skindex-16 differs between~     the store and forward and conventional care modalities.~   "
234362|NCT00488280|"~     The Kids STEP Study aims to~        1. Determine if walking can be restored in children with incomplete SCI and little to no~          leg movement~        2. Identify the neural pathways that permit recovery of walking~   "
234363|NCT00488267|"~     ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD~     (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated~     with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to~     moderate pain associated with osteoarthritis of the knee in adults.~   "
234364|NCT00488254|"~     Long QT Syndrome (LQTS) is a disease of young adults and can affect women of child bearing~     age. Suffers of LQTS are at risk of ventricular dysrhythmias including torsades de pointes~     and ventricular fibrillation.~      Pregnancy increases the chance that any mother may have an abnormal heart rhythm or~     arrhythmia. This chance is higher with the LQTS. There are only a few reported cases of women~     with the LQTS having a baby in the medical literature. This can make it difficult for the~     doctor caring for a pregnant woman with the long QT syndrome - especially should they need an~     anesthetic.~      We would like to study as many women who have had a baby who have the long QT syndrome to~     give us a better idea of whether there are any arrhythmias occurring at the time of delivery.~   "
234365|NCT00488241|"~     To show efficacy of Zarzenda in the treatment of hand eczema~   "
234366|NCT00488228|"~     The purpose of this pilot study is to determine whether incorporating self-regulation~     training using daily weighing is efficacious within a behavioral weight loss program~     specifically targeting young adults.~   "
234367|NCT00488215|"~     An escalating dose of prucalopride up to a maximum of 20 mg was given once daily to 32~     healthy volunteers to determine safety at the maximum tolerable dose or at 20 mg.~   "
234368|NCT00488202|"~     Women with Advanced Ovarian Cancer (AOC) suffer from severe sexual side effects from~     treatment. The prevalence of the sexual issues is not known.~      The degree to which these sexual side effects is affected by treatment is also not known, as~     the literature in this area focuses on post-treatment analysis.~      Specific Aim #1 (Quantitative Phase): To determine the prevalence and types of sexual~     difficulties using self-report questionnaires in women about to receive treatment for Stage~     III or IV Ovarian Cancer at the BCCA and over time, and to correlate these symptoms with~     degree of cancer symptoms, well-being, depressive symptoms, and relationship satisfaction~   "
234369|NCT00488189|"~     This is an antibiotic intervention study to determine the value of using~     piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae~     colonization and infection.~   "
234370|NCT00488176|"~     The aim of this study is to compare the effect of montelukast and cetirizine on allergic~     inflammation measured by exhaled nitric oxide concentration in children with seasonal~     allergic rhinitis.~   "
234371|NCT00488163|"~     Relationships between altered prefrontal cortical dopamine, norepinephrine and some cognitive~     impairments of schizophrenia supports and approach for pharmacological remediation of~     cognitive symptoms through manipulations of prefrontal cortical dopamine and norepinephrine.~     Atomoxetine, a selective norepinephrine re-uptake inhibitor, produces a widespread increase~     in brain norepinephrine and a secondary and selective increase in prefrontal dopamine. Given~     this, we are evaluating atomoxetine's cognitive effects in a pilot placebo controlled trial~     in patients with schizophrenia. Moreover, an fMRI investigation was undertaken to assess the~     neural mechanisms underlying the cognitive effects of atomoxetine.~   "
234372|NCT00488137|"~     The purpose of this study is to determine whether prucalopride is safe and effective in the~     treatment of chronic constipation.~      Hypothesis:~      Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the~     treatment of patients with chronic constipation and is well tolerated in those patients~   "
234373|NCT00488124|"~     Growth hormone therapy will improve the height of short statured children with pathological~     conditions that lead to growth retardation. Growth hormone therapy will show an increase in~     height velocity >1 SD compared to pretreatment height velocity. and the therapy will be safe.~   "
234374|NCT00488111|"~     Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar~     Score of children and related with the stable hemostasis during the whole process of labor.~     How to keep circulation in a consistent stability is yet to be known. The investigators~     hypothesized that different fluids, crystalloids or colloids, can produced varying effects in~     keeping the physiological environment of labor from significant fluctuating.~   "
234375|NCT00488098|"~     The study is to show the new salt formulation of GSK372475 is equivalent to the old salt~     formulation of GSK372475.~   "
234376|NCT00488085|"~     The aim of our study is to suggest possible underlying mechanisms for the observed clinical~     differences in disease severity and behavior of overweight and obese patients with crohn's~     disease(BMI > 25 kg/m²)as compare to non-obese crohn's patients with a normal or low weight (~     BMI ≤ 25) by measuring metabolic\nutritional variables and cytokine levels.~   "
234497|NCT00486512|"~     The purpose of the study is to investigate if long-term treatment with three known drugs~     (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents~     recurrence of colorectal adenomas.~   "
234377|NCT00488072|"~     Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to~     placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An~     improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on~     the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days).~      Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve~     insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29~     ( +/- 3 days)~      Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve~     other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and~     anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as~     measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients~     with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days)~      Other Objectives:~      To provide exploratory data on the effects of Mirtazapine on weight gain, and~     preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance),~     on days 15 (+/-3 days), and 29 (+/-3 days).~      To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on~     decreased side effects of drug and increased appetite on day 29 (+/-3 days).~   "
234378|NCT00488059|"~     This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in~     an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1~     infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of~     the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily~     until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator~     phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day~     or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were~     terminated from the study. The anticipated time on study treatment was 3-9 months, and the~     target sample size was 210 individuals.~   "
234379|NCT00488046|"~     Over the past decade, avian influenza (AI) has become a major health concern. The development~     of a safe and effective vaccine against H5N1 infection is important. The purpose of this~     study is to determine the safety of a new AI vaccine in healthy adults.~   "
234380|NCT00488033|"~     Patients with a known history of diabetes mellitus and no prior documented evidence of~     cardiovascular disease will be evaluated for inclusion in the study. Once qualified, patients~     will be enrolled and be randomized to either the Control Arm or to the Asymptomatic Screening~     Arm. Patients in the Control Arm will be followed by their primary care physicians with the~     recommendation that they follow standard guidelines for management of diabetic patients.~      Patients in the Asymptomatic Screening Arm will undergo CT screening for either coronary~     calcium scoring or multi-slice CT angiography as well as be placed on one of two medical~     regimens. Patients will be followed by telephone at six-month intervals for a minimum of one~     year for both primary and secondary outcomes.~   "
234381|NCT00488020|"~     Collection of bone marrow blood Selection of mononuclear cells dilution with albumin~     injection into the calf muscles through 40 shots~   "
234382|NCT00488007|"~     This is a 12-months' randomized clinical trial that aims at studying the benefit of bilateral~     hearing aids in hearing impaired patients suffering from a slight to moderate stage Alzheimer~     disease.~      The benefit of this intervention will be studied in the cognitive, behavioural, quality of~     life and economic fields.~      2groups are involved in this trial: Intervention group: 12 months' treatment with active~     hearing aids, fitted hearing impairment Control group: 6 months' treatment with placebo~     hearing aids, followed with 6 months' active hearing aids, fitted hearing impairment~   "
234383|NCT00487994|"~     The purpose of this study is to evaluate the overall safety of Lapaquistat Acetate, once~     daily (QD), by itself or in combination with atorvastatin in subjects with primary~     dyslipidemia.~   "
234384|NCT00487981|"~     The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals~     who suffer from painful diabetic peripheral neuropathy. Patients invited to participate in~     this study will be eligible for SCS therapy, and will have already selected therapy with the~     Advanced Bionics Precision system independent of possible inclusion in this study. The~     device, accessories, and procedures associated with device placement and the indications for~     use are all consistent with the current and approved product labeling.~   "
234385|NCT00487968|"~     Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric~     thrombocytopenia, this study will help determine the best tasting pediatric formulation of~     eltrombopag. Healthy adult volunteers who are able to taste bitterness and who do not have a~     high sensitivity to bitterness will be enrolled. The subjects will evaluate different~     formulations and rate them based on the bitterness and effectiveness of sweetners. The~     outcome of this study will help support a decision for a new pediatric formulation of~     eltrombopag.~   "
234386|NCT00487955|"~     The purpose of our study is to evaluate the metabolic contribution of the human microbiota to~     resting energy expenditure~   "
234387|NCT00487942|"~     The primary objective of this study is to evaluate if adjunctive armodafinil treatment can~     improve the cognitive deficits in patients with schizophrenia~   "
234388|NCT00487929|"~     The purpose of this study is to compare the levels of 8-isoprostane and other oxidative~     stress biomarkers in plasma and condensed exhaled air between patients with SAHS and~     cardiovascular complications, patients with SAHS without cardiovascular complications and~     control subjects. To evaluate the effect of three months of treatment with CPAP on the~     oxidative stress biomarkers.~   "
234433|NCT00487344|"~     The purpose of this study is to compare the use of personalized low-fat meal plans vs.~     non-personalized low-fat meal plans and the results in body fat reduction in overweight and~     obese subjects 25 to 45 years of age.~      Compensation to Eligible Participants:~        1. FREE Nutritional Services will be provided to eligible participants, which normally have~          a business value of between $165.00 and $195.00.~        2. Each eligible participant will receive compensation for mileage directly related to this~          study up to 35 miles at the 2007 IRS Business Mileage Reimbursement Rate for medical~          purposes of $0.20 per mile. This compensation will be provided to each eligible~          participant in the form of a complimentary Wal-mart Gift Card in the amount of $7.00,~          contingent upon his or her completion in the study.~   "
234434|NCT00487331|"~     The goal of this clinical research study is to learn if using acupuncture with or without~     electrical stimulation in cancer patients with high levels of pain can help to relieve the~     pain.~   "
234389|NCT00487916|"~     This study will evaluate the safety and effectiveness of a vaccine called AMA1-C1/ISA.~     Malaria is a serious infection of red blood cells caused by a parasite. There are 300 to 500~     million malaria cases worldwide each year. About 2 to 3 million deaths annually are from~     malaria alone or along with other diseases. Researchers hope to find a vaccine to fight~     malaria.~      Patients ages 18 to 45 who are in good health, are not pregnant or breast feeding, have no~     history of malaria, and have not lived for more than 1 month in an area where malaria is~     prevalent may be eligible for this study. There will be 28 participants, each assigned to one~     of three dose groups: 12 get 5 microg, 12 get 20 microg, and 4 get 80 microg of AMA 1-C1~     formulated in ISA 720. The vaccine might block the parasite from entering red blood cells and~     causing disease. This study is the first time the vaccine will be given to human beings for~     testing.~      Patients will have a medical history, physical exam, laboratory tests, and pregnancy tests.~     The study will last 48 weeks. One or two vaccinations are given by injection, at least 12~     weeks apart. After each vaccination, patients will be asked to stay in the clinic for at~     least 30 minutes for observation. They will return to the clinic on Days 1, 3, 7, 14, 28, and~     56 after each vaccination. There will be a check of vital signs, brief physical exam, history~     of symptoms and medications taken since the last visit, and blood tests to check for vaccine~     safety and effectiveness. Photographs of the injection site on the arm may be taken. Patients~     will receive a thermometer, diary card, and plastic measuring device. Each day they will~     record their temperatures and any symptoms, and measure the size of any reactions at the~     vaccination site. They will be asked to do this for 27 days after vaccinations.~      After injections, there may be pain, swelling, and redness at the vaccination site, and~     limitation of arm movement. General side effects from the vaccine may be fever, chills,~     headache, fatigue, and muscle and joint pain. Patients will be asked if they agree to have~     researchers keep any unused serum samples, for use only in research into malaria and other~     diseases. Genetic testing would not be done on those samples. Stored samples will be labeled~     with a code, and information is kept private.~   "
234390|NCT00487903|"~     The purpose of this clinical trial is to evaluate various commercially available ultrasound~     systems and to identify imaging parameters to be used with these systems (along with the~     contrast agent PB127) as well as to further evaluate the safety of PB127.~   "
234391|NCT00487890|"~     The purpose is to identify modifiable factors in older adults associated with functional~     decline following major non-emergent surgery. The hypothesis of this proposal is that poor~     preoperative exercise tolerance and physical performance, potentially modifiable factors, are~     crucial in predicting functional decline and disability following surgery. When completed,~     this study will reveal detailed information on the incidence and risk factors for functional~     decline in older adults following surgery. It will direct future research targeting~     interventions in older adults at highest risk for functional decline following surgery,~     thereby decreasing the incidence of premature disability.~   "
234392|NCT00487877|"~     To investigate the relationship between hungry-satiation situation including meal time and~     metabolism, skin temerature changing, simpathetic & para-simpathetic response To investigate~     the relashionship between hungry-satiation situation including meal time and heart rate~   "
234393|NCT00487864|"~     In vivo confocal laser scanning microscopy (CLSM) offers the possibility to non-invasively~     investigate skin lesions at nearly histologic resolution. A recent study showed a high~     sensitivity (97.6%) and specificity (88.15%) for the discrimination of clinical clear cut~     melanocytic lesions. CSLM provides horizontal images and can be seen as missing link between~     dermoscopy and histopathology. For a more accurate diagnosis of dermoscopically difficult to~     diagnose melanocytic skin lesions in the grey zone between nevus and melanoma, the knowledge~     of CLSM features of benign nevi seems to be essential. We investigated 30 flat benign nevi~     with different dermoscopic patterns (10 reticular, 10 globular, 10 homogeneous) nevi. CLSM~     images were assessed in terms of cytomorphologic and architectural criteria. Different~     dermoscopic patterns of benign nevi are reflected in different architectural features in~     CLSM.~   "
234394|NCT00487851|"~     Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery~     in non-resectable periampullary cancer~   "
234395|NCT00487838|"~     This study will test a new method for preventing worsening of age-related macular~     degeneration (AMD) and for developing imaging methods to follow the very earliest microscopic~     changes in the disease. The macula is the part of the retina in the back of the eye that~     determines central vision. AMD can impair central vision, affecting a person's ability to~     read, drive, and carry out daily activities. Some studies suggest that cumulative exposure to~     sunlight increases the risk for progression of AMD to the late stage that is often~     characterized by poor central vision. This study will determine if wearing glasses with a~     yellow filter over one eye and a red-violet filter over the other eye when outdoors will~     decrease the rate of change of early-stage AMD in one or both eyes.~      Patients early-stage AMD who have had cataract surgery in both eyes with implanted lenses may~     be eligible for this study.~      Participants undergo the following procedures:~        -  Wear the filter glasses when outdoors between 10:00 a.m. and 4:00 p.m.~        -  Record the time of day and light environment when they use the glasses.~        -  Have an eye examination, pictures of the retina, and a medical history taken at the~          beginning of the study and at set intervals during the study.~      The study lasts at least 12 months and may be extended for a longer period of time....~   "
234396|NCT00487825|"~     This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and~     oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)~   "
234397|NCT00487812|"~     Left myocardial infarction (MI), has a negative impact of long term morbidity and mortality.~     Even in patients treated successfully by angioplasty in the acute phase of infarct, the~     remodelling is observed in approximately 30% of cases. It is important to predict the~     occurrence of this phenomenon in the early phase after MI for the selection of patients who~     could eventually benefit from new therapeutic approach as for example cell replacement~     therapy. It has been advocated that stem cells coronary injections should be performed~     between the 5th and 10th day after an acute event. We hypothesise that a low dose dobutamine~     gated Tc-99m-mibi SPECT performed on 5th-6th day after reperfused acute MI can predict left~     ventricular remodelling and serve as a method to screen patients who could benefit from cell~     replacement therapy.~   "
234398|NCT00487799|"~     To determine the maximum tolerated dose (MTD) of ularitide in the treatment of subjects~     hospitalized with symptomatic acute decompensated heart failure (ADHF).~   "
234399|NCT00487786|"~     This study is for patients with cancer who have failed potentially curative treatments or for~     whose disease a curative treatment does not exist.~      OGX-427 is an antisense product that inhibits expression of one of the heat shock proteins.~     Decreasing this heat shock protein (Hsp27) should result in down regulation of pathways~     implicated in cancer progression and development of resistance to treatment.~   "
234400|NCT00487773|"~     The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on~     bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with~     asthma.~   "
234401|NCT00487760|"~     This study will learn more about the beliefs of family members of African American patients~     with lung cancer and whether these beliefs are associated with their interest in genetic~     testing for disease risk and willingness to participate in genetics research. Lung cancer is~     the second most common form of cancer and the leading cause of cancer deaths for men and~     women in the United States. Like most cancers, there are racial and ethnic disparities (gaps)~     in lung cancer cases and deaths. The age-adjusted rates for blacks and whites (years 2000 to~     2003) was 76.9 per 100,000 and 66.0 per 100,000, respectively. Mortality rates were 62.5 per~     100,000 for blacks and 55.3 per 100,000 for whites. Cigarette smoking is the most preventable~     cause of lung cancer. Findings are that African Americans begin smoking at older ages and~     smoke fewer cigarettes per day than Caucasian Americans do. Yet the severity of lung cancer~     is greater for African Americans. Behavioral, social, environmental, and genetic factors may~     explain the differences.~      Participants (subjects) ages 18 to 55 who are family of patients with lung cancer who~     self-identify as African Americans may be eligible for this study. Washington, D.C.,~     researchers plan to recruit 115 lung cancer patients and 200 family members-100 current~     smokers and 100 who never smoked. Lung cancer patients, who must have been born in the United~     States, will be recruited from those who are receiving care at the Washington Cancer~     Institute at the Washington Hospital Center. They will be asked to list relatives and friends~     they consider to be as close as family. Patients will be asked permission for researchers to~     contact those people. Family members will receive a letter telling them that unless they~     decline to participate, they will be contacted by a telephone interviewer.~      The survey will feature questions to evaluate family members' explanations for the causes of~     lung cancer, as well as their reactions to possible reasons for the disparity in lung cancer~     between African Americans and Caucasian Americans. Subjects will be asked about perceived~     personal risk, worry about developing lung cancer, smoking history, motivation to quit~     smoking, feelings about the lung cancer patient's diagnosis, racial identify, experience with~     racial discrimination, pros and cons of genetic testing, and interest in genetic testing. The~     survey will take up to 20 minutes to complete.~      This study may or may not have a direct benefit for those who participate. However, lung~     cancer patients and their families will be offered a free self-help guide to stop smoking.~     They will be referred to local smoking cessation programs. Knowledge gained from the study~     may be used to design smoking cessation methods and research studies related to genetics for~     minority populations.~   "
234402|NCT00487747|"~     This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic~     hepatitis B who are either treatment-naive, or who have failed lamivudine- or~     interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c.~     weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time~     on study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
234403|NCT00487734|"~     This study aims to determine whether testosterone replacement improves insulin sensitivity in~     non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome~     includes three of the following five conditions, 1) an elevated blood pressure (greater than~     130/85), 2) a triglyceride level greater than 150 mg/dl, 3) an HDL-cholesterol less than 40~     mg/dl, 4) glucose levels greater than 100 mg/dl, and 5) a waist measurement greater than 40~     inches.~   "
234404|NCT00487721|"~     Silibinin has demonstrated anti-cancer activity in the laboratory for several different~     cancer types, including prostate cancer. Silibinin was originally obtained from milk thistle.~     Silybin-Phytosome, an oral form of silibinin, has been tested previously in prostate cancer~     patients to determine the safety of high-dose treatment. This study is for men with prostate~     cancer who are planning to have their prostate surgically removed. Participants will be given~     Silybin-Phytosome three times a day from enrollment in the study until the time of their~     surgery. Participation in this study will not affect the timing of surgery. We obtain blood~     and urine samples at the start and completion of the trial in addition to prostate tissue~     from the surgery. These samples will be analyzed for the effect of Silybin-Phytosome at the~     end of the study.~   "
234405|NCT00487708|"~     This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and~     pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients~     with NALP3 mutations whose clinical symptoms are either untreated or insufficiently treated~     and require medical intervention.~   "
234406|NCT00487695|"~     The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve~     detection of Barrett's esophagus, dysplasia, and early esophageal cancer.~   "
234407|NCT00487682|"~     To investigate the efficacy and safety of three different doses of ASP2151, as compared to~     valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended~     clinical dose.~   "
234408|NCT00487669|"~     This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and~     dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in~     combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC.~   "
234409|NCT00487656|"~     The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin)~     decreases the number of people who die as a result of Disseminated Intravascular Coagulation~     (DIC) complication of sepsis.~   "
234410|NCT00487643|"~     Purpose: to build a library of normal tear lacritin values by collecting tears from normal~     adult human subjects and to develop a non-invasive clinical assay for lacritin. Such an assay~     will provide more sensitive indicators of eye disease for clinicians and determine if a~     particular therapy, such as recombinant lacritin drops, is of benefit.~   "
234411|NCT00487630|"~     Fabry disease (OMIM 301500) is an X-linked inborn error of sphingolipid metabolism resulting~     from the deficiency of the lysosomal enzyme alpha-galactosidase A. Heterozygous females for~     Fabry disease may be symptomatic with cardiac, renal or cerebrovascular involvement.~     Clearance of Gb3 and stabilization of renal function has been demonstrated in male patients~     treated with agalsidase beta (FABRAZYME). In contrast, no randomized, controlled study of the~     efficacy of recombinant alpha-galactosidase A has been reported in heterozygotes for Fabry~     disease.~   "
234412|NCT00487617|"~     To determine whether fruit juice might reverse endothelial dysfunction and whether this~     reversibility has a prognosis value~   "
234413|NCT00487604|"~     The purpose of this study is to determine whether the use of drug eluting stents is~     associated with higher rates of death, myocardial infarction, and major bleeding. In~     addition, the overall economic costs of implanting drug eluting stents compared to bare metal~     stents will be assessed.~   "
234414|NCT00487591|"~     The primary objective of this study is to compare the effect of simvastatin plus Omacor to~     simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects~     with mixed dyslipidemia.~   "
234415|NCT00487578|"~     The purpose of this study is to determine whether naratriptan, a medication approved for~     treatment of migraine, is effective in the treatment of post traumatic headache associated~     with cognitive dysfunction.~   "
234416|NCT00487565|"~     Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior~     stabilized design of the LCS® Complete Mobile-bearing Total Knee System~   "
234578|NCT00485459|"~     The purpose of this protocol is to investigate the acute treatment efficacy, safety, and~     tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and~     adolescents with ADHD.~   "
234422|NCT00487487|"~     Post-Poliomyelitis Syndrome (PPS) is the term describing the new problems affecting polio~     survivors many years after recovery from paralytic polio. Among the symptoms, fatigue is one~     of the most frequent and debilitating. In addition to physical incapacitation, the fatigue of~     PPS also affects mental function. The term “brain fatigue” is usually used by patients to~     express problems on the areas of attention, concentration, memory and clear thinking.~     Unfortunately, little is known about cognitive fatigue of PPS patients. This study is meant~     to examine if mental impairment is present in PPS patients and, if so, how it interferes on~     the self-function of patients. Patients will undergo an interview, clinical and neurological~     evaluation, and a battery of screening laboratory tests to make sure they are eligible for~     the study. Patients who qualify will undergo neuropsychometric tests in order to assay~     performance in the main areas of cognitive functioning. Through this organized approach we~     expect to be able to determine if mental fatigue is a significant problem affecting polio~     survivors, what areas are most affected, and how it may interfere with daily living.~   "
234423|NCT00487474|"~     -  Measure the mid-facial volumetric correction from SCULPTRA treatment, using~          three-dimensional digital surface imaging~        -  Determine the mean change from baseline in facial contour deficiency as measured by the~          Dermik Nasolabial Photo-numeric Scale~        -  Correlate volumetric correction with clinical improvement as measured by the Dermik~          Nasolabial Photo-numeric Scale~        -  Correlate the mean volumetric change in mid-facial treatment area with the amount of~          product used~        -  Evaluate subject and investigator global assessment of improvement and subject treatment~          satisfaction at the end of treatment~        -  Obtain photographs pre- and post-treatment for the purpose of providing a subject visual~          aid during the course of treatment~        -  Collect safety data~   "
234424|NCT00487461|"~     The purpose of this study is to test whether treatment with a drug called Simvastatin~     prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is~     currently approved for the treatment of high cholesterol levels.~   "
234425|NCT00487448|"~     Association group of therapeutic specialities authorized in a remission induction~     treatment(FLAG-IDA: fludarabine, cytarabine, G-CSF (lenograstim) and idarubicin) and an~     intensive postremission treatment with authorized therapeutic association specialities and~     with/without Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation~     in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic~     Leukemia.~   "
234426|NCT00487435|"~     The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503)~     extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients~     with moderate to severe chronic pain over a period of 1 year. The study will also assess~     dosage requirements over the long term; characterize adverse events and tolerability, sleep~     quality, and potential symptoms of withdrawal; characterize pain intensity scores and overall~     impression of change; and characterize patient-related health outcomes.~   "
234427|NCT00487422|"~     The purpose of this study is to determine whether prucalopride is safe and effective in the~     treatment of chronic constipation in elderly patients.~      Hypothesis:~      Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the~     treatment of patients with chronic constipation and is well tolerated in those patients~   "
234428|NCT00487409|"~     The purpose of this research is to compare two different standard of care surgical methods~     for the following large bowel (colon) procedures: laparoscopic right colectomy, total~     colectomy, and left colectomy. The study will compare electrocautery, used with surgical~     clips and/or surgical staplers, and the Ligasure vessel sealer. The investigators will be~     looking at which procedure is faster and more cost efficient and the investigators will~     calculate hospital expenses for the two groups to make comparisons.~   "
234429|NCT00487396|"~     The aim of this study is to validate the ability of Capsule Endoscopy (CE) to accurately~     diagnose small bowel (SB) Crohns disease in patients with symptoms of abdominal pain and~     diarrhea.~      The primary objective of the study is to evaluate whether Capsule Endoscopy prior to~     colonoscopy will improve diagnosis in patients with suspected Crohns disease when compared to~     standard diagnostic testing.~   "
234430|NCT00487383|"~     This study will examine the role of certain areas of the brain in blepharospasm, a type of~     dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable~     blinking or closing of the eyelids. The study will compare brain activity in healthy~     volunteers and in people with blepharospasm to find differences in the brain that may lead to~     better treatments for dystonia.~      Healthy volunteers and people with blepharospasm who are 18 years of age and older may be~     eligible for this study. All candidates are screened with a medical history. People with~     blepharospasm also have a physical examination and blepharospasm rating.~      Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in~     two 4-hour sessions, separated by 1 to 7 days.~      TMS~      A wire coil is held on the subject s scalp. A brief electrical current is passed through the~     coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may~     feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the~     face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles~     slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses~     delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes.~      EMG~      Surface EMG is done during TMS to measure the electrical activity of muscles. For this test,~     electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the~     face.~   "
234431|NCT00487370|"~     The purpose of this study is to determine whether implanting gold beads extraarticularly in~     five acupuncture-points around a knee improves pain, stiffness and function in patients with~     knee osteoarthritis.~   "
234432|NCT00487357|"~     Primary Objectives:~        1. To collect data on health behaviors in the parents of MATCh study participants~        2. To collect and/or update risk factor data from the parents of the MATCh study~          participants.~   "
234446|NCT00487175|"~     Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for~     example in neuropathic pain is not very well known. This protocol aims therefore at studying~     the effect of tramadol in a human pain model with sensitization induced by a cold stimulus,~     using evoked potentials to elucidate how pain is modified when tramadol is administered.~   "
234435|NCT00487318|"~     Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy.~     Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans~     Administration. It is a randomized control format including genotypes 1 and 3. There will~     also be pilot arms for HCV carriers who present for screening already on a statin, who will~     be allowed to stay on their current statin or switched to another statin. In all ways,~     standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package~     insert.~   "
234436|NCT00487305|"~     The purpose of this study is to compare the safety and immune activity of three doses of~     tumor vaccine. In recent years, researchers at the Dana-Farber Cancer Institute have~     discovered that vaccines made from patient's own cancer cell, that have been engineered in~     the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful~     immune response specific to that cancer. GM-CSF is a naturally occuring hormone in the body~     that helps our immune system fight infections and diseases. One of the goals of this study is~     to determine whether these vaccinations will improve the immune system's ability to recognize~     and destroy the participant's lymphoma cells.~   "
234437|NCT00487292|"~     Design: paired trials without and with naps and bright light. Setting: Real driving on a~     private road circuit. Environmental controlled car. Participants: 9 shift workers on tree~     shifts (morning-afternoon-night) Measurements: Sleepiness at the wheel was measured by~     ambulatory polysomnography and assessed using 30 seconds segments of recordings when the~     percentage of theta EEG was at least 50% (15 seconds) of the period recorded. Subjects were~     also called to rate their sleepiness on the 7-point Stanford Sleepiness Scale (SSS).~      Intervention: Participants drove the same car on two similar 24 hours periods of work, with~     three pilots in each shift (morning, afternoon, night), separated by three weeks. During the~     baseline period, the subjects were told to manage their rest as they usually do in the real~     life. During the second experimental period, they had to rest lied in a dark room during two~     naps of 20 minutes and then exposed to bright light pulse (5000 lux) during 10 minutes.~   "
234438|NCT00487279|"~     This trial is a prospective, multi-center, randomized study of patients with coronary artery~     disease (CAD) and mild to moderate left ventricular (LV) dysfunction. The primary objective~     of this study is to test the hypothesis that Implantable Cardioverter Defibrillator (ICD)~     therapy in combination with medical therapy in patients with an infarct size greater than or~     equal to 10% of the left ventricular mass improves long term survival compared to medical~     therapy alone. In addition to the 2-arm randomized trial, the study will also include a~     non-investigational registry of non-randomized patients.~   "
234439|NCT00487266|"~     The goal of this proposal is to test the overall hypothesis that subjects with chronic or~     recurrent low back pain have an abnormal soft tissue response to acupuncture needling, and~     that this altered response is associated with abnormal perimuscular connective tissue~     structure and biomechanics. We will also test whether or not altered needling responses in~     low back pain are generalized, or localized to specific locations as predicted by traditional~     acupuncture theory. This proposal is part of a series of projects investigating the role of~     connective tissue in the mechanism of acupuncture and, in addition, constitutes a first step~     in examining the role of connective tissue in low back pain. Acupuncturists describe~     qualitatively different needling responses at locations believed to be involved in the~     patient's disease process. Although assessing abnormalities in the needling response is a~     fundamental aspect of acupuncture therapy, what constitutes a normal vs. abnormal needling~     response has never been studied quantitatively. Thus the nature of tissue changes underlying~     these phenomena remains unknown. We have recently developed a new in vivo technique based on~     ultrasound elastography that allows visualization and quantification of tissue displacement~     and strain patterns developed in tissues during needle manipulation in humans [1] (Appendix~     A). In this proposal, we will use ultrasound elastography, ultrasound image analysis and~     biomechanical modeling to perform 1) quantitative measurement of soft tissue behavior during~     needling and 2) detailed analysis of perimuscular connective tissue structure and~     biomechanics in human subjects with and without low back pain.~   "
234440|NCT00487253|"~     The purpose of this randomized, open label clinical trial is to determine if oral miltefosine~     is a safe and effective alternative, compared with parenteral meglumine antimoniate for the~     treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.~   "
234441|NCT00487240|"~     The purpose of this study is to examine the efficacy and safety of insulin lispro protamine~     suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime~     insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for~     sequentially testing the secondary objectives.~   "
234442|NCT00487227|"~     It is often assumed that levels of caffeine found in 'decaffeinated' beverages are below any~     psychopharmacological threshold. However, recent findings indicate that caffeine doses as low~     as 9 mg may be psychoactive. The effects of caffeine have also been shown up to 6 hours~     post-administration. The study aimed to establish the lowest active dose of caffeine, and to~     ascertain the duration of any effects.~   "
234443|NCT00487214|"~     The purpose of this study is to evaluate the range of target IOPs set for glaucoma patients~     starting monotherapy with bimatoprost and to evaluate patient and physician satisfaction with~     bimatoprost in real-world settings~   "
234444|NCT00487201|"~     Background and Study Aims: Biliary strictures are a major cause of morbidity following liver~     transplantation with an overall incidence between 10 and 30 %. Up to now biliary strictures~     were dilated subsequently one to three plastic stents with a diameter of eight to ten F were~     inserted. In general, stents were exchanged in two to three months intervals over one year.~     In the present prospective controlled study, efficacy and complication rates of balloon~     dilation have been compared with dilation plus stenting.~      Patients and Methods: XY patients with high-grade biliary strictures (anastomotic and~     non-anastomotic) were enrolled in this prospective study in random order. X patients were~     treated by endoscopic balloon dilatation and Y by balloon dilatation plus plastic stent~     placement in six to eight weeks intervals. The primary end point was permanent opening of the~     biliary obstruction of 12 months. Number of endoscopic interventions and complications of the~     procedures were monitored.~   "
234445|NCT00487188|"~     To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with~     HAART alone in achieving and maintaining viral load suppression.~   "
234447|NCT00487162|"~     Surgery induces a stress effect on the body partially through a catabolic energy state. In~     turn, glucose levels may rise to levels which have been associated with major morbidity~     (Golden, 1999) and mortality (Ouattara, 2005). An increasing body of evidence suggests that~     intensive insulin therapy for tight control of blood glucose levels in certain surgical and~     critical care patient populations may improve mortality and selected morbidity outcomes when~     compared to those patients receiving conventional insulin therapy and blood glucose~     management. More specifically, poor intra-operative blood glucose control is associated with~     worse outcome after cardiac surgery. Intensive insulin therapy with tight blood glucose~     control in surgical patients while in the ICU may reduce morbidity and mortality. Such~     outcome improvements would clearly provide benefits to patients, providers and payers. To~     date, there is scant research examining whether intensive insulin therapy for tight control~     of blood glucose in the perioperative period can alter outcomes for the non cardiac surgery~     population. The purpose of this study is to determine whether intensive insulin therapy for~     tight control of blood glucose in the perioperative period in non cardiac major surgery~     patients is associated with altered morbidity and mortality rates.~   "
234448|NCT00487149|"~     Respiratory muscle strength is used as an outcome measure in intervention studies. There are~     reference values for respiratory muscle strength in 'healthy' people but not in those with~     bronchiectasis disease. The aim of this study is to investigate the reliability of~     respiratory muscle strength measurements and identify reference values for those with stable~     moderate to severe bronchiectasis disease.~   "
234449|NCT00487136|"~     This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in~     adult male subjects in general good health.~   "
234450|NCT00487123|"~     This study will evaluate the efficacy of the reminder device Remind Cap® in improving~     patients' compliance in the consumption of Valsartan +/- Hydrochlorothiazide (HCTZ) in the~     treatment of hypertension~   "
234451|NCT00487110|"~     A previous study has shown that tropisetron inhibits the analgesic effect of paracetamol in~     healthy volunteers. This study aims at confirming this pharmacodynamic interaction in~     patients with post-surgery pain.~   "
234452|NCT00487097|"~     The purpose of this study is to investigate whether the addition of omega-3 and antioxidants~     to nutritional support in critically ill patients in the intensive care unit influences the~     immune and anti-inflammatory systems and so improves wound healing.~   "
234453|NCT00487084|"~     Epidural chloroprocaine is often used in obstetrical anesthesia because of its fast onset and~     short duration. These properties make it an ideal drug to use for epidural anesthesia in~     patients undergoing postpartum tubal ligation. When epidural morphine is given after~     chloroprocaine, there is a decreased efficacy of analgesia as compared to lidocaine (1).~     Several studies have hypothesized a specific opioid receptor mediated antagonism of~     chloroprocaine (2,3). Karambelkar raised the question whether this decreased efficacy is due~     to a disparity between the time the chloroprocaine anesthesia resolves and the onset of~     epidural morphine analgesia, resulting in a time window of pain (2). The duration of action~     of epidural 2-CP anesthesia is 30-45 minutes and the onset of epidural morphine analgesia is~     60-70 minutes, therefore the regression of sensory blockade before the onset of the morphine~     analgesia could result in a window of pain (2). Hess and colleagues studied epidural morphine~     analgesia and women who had a Cesarean delivery under spinal bupivacaine anesthesia (3).~     Subjects were randomized to receive epidural 2-CP and morphine or epidural saline and~     morphine. There was no difference in postoperative analgesia between the two groups (3 and~     personal communication, Dr. Philip Hess). A literature search cross referencing epidural~     chloroprocaine, using Pub Med, did not produce any articles comparing epidural morphine given~     before the procedure (in an attempt to time the onset of analgesia with the resolution of~     chloroprocaine anesthesia) to the standard administration time after the procedure.~   "
234454|NCT00487071|"~     The aim of this pilot study is to evaluate the efficacy and safety of anal fistula plug in~     the management of high-type anal fistulae among Hong Kong Chinese patients.~   "
234455|NCT00487058|"~     This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in~     Japanese patients. Gimatecan is administered orally twice per week, every 28 days, to adult~     patients with advanced solid tumors who have progressed despite standard therapy or for whom~     standard systemic therapy dose not exist.~   "
234456|NCT00487045|"~     This study is being conducted to evaluate an investigational instrument called the HEM-AVERT~     Perianal Stabilizer and its efficacy in reducing the occurrence or severity of hemorrhoids~     and thrombosed external hemorrhoids (TEH) which commonly occur during vaginal delivery.~   "
234457|NCT00487032|"~     The investigators wish to evaluate the onset of tolerance to nasal decongestants like~     oxymetazoline (available over the counter) and the mechanism of tolerance particularly with~     differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. The investigators~     will 'tease' out by using an alpha 1 blocker called Prazosin. The investigators hypothesize~     that alpha 1 receptors mediate arterial constriction and this will be captured by measuring~     nasal blood flow. The investigators also hypothesize that alpha 2 receptors mediate venous~     sinusoid constriction and this the investigators will capture by airflow parameters like Peak~     Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.~   "
234458|NCT00487019|"~     A prospective two-center antibiotic regimen switch study will be conducted to compare the~     clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus~     ampicillin/gentamicin - in the empirical treatment of early onset neonatal sepsis. The~     influence of either regimen on bowel colonization pattern and on the development of~     antibiotic resistance of gut microflora will also be assessed. The primary endpoint is the~     need for a change in antibacterial treatment within 72 hours of therapy, based on pre-defined~     criteria. Secondary endpoints will be the incidence rate and etiology of early and late onset~     neonatal sepsis and susceptibility pattern of causative microorganisms; mortality rate within~     60 days; duration of hospitalization in NICU; duration of artificial ventilation;~     colonization pattern and susceptibility of colonizing bacteria (including resistance to~     empiric antibiotic regimen).~   "
234481|NCT00486720|"~     This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients~     with lower risk Myelodysplastic Syndrome (MDS).~   "
234482|NCT00486707|"~     The objective of this study is to evaluate the willingness of patients with ovarian cancer to~     undergo genetic testing, given the cost, their understanding and acceptance of genetic~     testing and the possibility of targeted therapy.~   "
234459|NCT00487006|"~     BACKGROUND AND PURPOSE~      Critical illness hyperglycemia (CIH) - elevated blood glucose in the critically ill patient~     population - has gained much interest among health care providers over the past several~     years. Clinical studies in adults have documented a high rate of hyperglycemia in some~     post-surgical and medical intensive care units (ICUs). However, the primary reasons for~     interest in this topic are not due just to its high rate, but also to the fact that by~     returning the high glucose levels found in this population to normal with insulin therapy can~     dramatically improve clinical outcomes by decreasing both morbidity and long-term mortality.~     Because of this, aggressive glucose control has become common practice in adult ICU critical~     care management.~      Although there is substantial data describing the high incidence of CIH in adult patients,~     there is little information regarding this condition in children. A single retrospective~     study recently published also suggested a high incidence of CIH in children with critical~     illness secondary to both medical and surgical causes. It is yet to be determined if, like in~     adults, normalizing blood glucose levels with insulin improves outcomes in this pediatric~     population. Because evidence appears compelling that hyperglycemia is both common and~     detrimental in adults, many pediatric ICUs have likewise begun to focus on aggressively~     treating hyperglycemia in critically ill children.~      The proposed study is a prospective observational pilot study to occur in the Pediatric~     Intensive Care Unit (PICU) at Children's Healthcare of Atlanta at Egleston. This prospective~     pilot study is being done to evaluate the endocrine factors associated with, if not~     responsible for, CIH, and the changes that take place with the restoration of normal blood~     glucose levels by insulin therapy.~      To address these profound issues this study will pursue two interrelated Aims:~      Aim #1: To determine if critical illness hyperglycemia is associated with absolute insulin~     deficiency, peripheral insulin resistance, or both.~      Aim #2: To characterize the requirement of insulin required to initially restore and maintain~     normal blood glucose levels, and compare the changes in insulin that take place with this~     normalization in patients with CIH.~      We hypothesize that the hyperglycemic response to critical illness will be associated with~     abnormally low levels of insulin as compared to patients without critical illness~     hyperglycemia.~   "
234460|NCT00486993|"~     According to WHO estimations, cardiovascular diseases (CVDs) are the number one cause of~     death globally. More people die annually from CVDs than from any other cause. An estimated~     17.5 million people died from CVDs in 2005, representing 30% of all global deaths. Of these~     deaths, an estimated 7.6 million were due to coronary heart disease and 5.7 million were due~     to stroke.~      Over 80% of CVD deaths take place in low- and middle-income countries and occur almost~     equally in men and women. In Paraguay, prevalence of classic risk factors, as well as new~     ones, like the metabolic syndrome are not completely known.~      Government health policies in industrialized countries are focusing on programs to modify~     cardiovascular risk factors. In developing countries, prevention of coronary heart disease~     and stroke through modification of cardiovascular risk factors are not playing a large role~     at the moment.~      The aim of this study is to define the effects of changes in lifestyle on cardiovascular risk~     factors, when added to optimized standard pharmacological therapy for arterial hypertension,~     diabetes mellitus and hyperlipidemia, in an ambulatory urban patient population.~   "
234461|NCT00486980|"~     This is a multinational, randomized, double-blind study comparing the efficacy and safety of~     two single dose regimens of peramivir administered intramuscularly versus placebo in adults~     with uncomplicated acute influenza.~   "
234462|NCT00486967|"~     Whether insulin resistance common among Chronic Heart Failure (CHF) patients in Tayside and~     identify factors associated with insulin resistance in CHF.~      We also want to identify mechanism for the impaired exercise capacity and reduced peak VO2 in~     CHF~   "
234463|NCT00486954|"~     EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the~     optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is~     designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel~     compared to patients receiving only paclitaxel.~   "
234464|NCT00486941|"~     The purpose of this study is to determine whether a short group intervention programe aiming~     at lifestyle changes at a local health centre can improve risk factors for cardiovascular~     disease~   "
234465|NCT00486928|"~     Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in~     Oslo in 1977. A total of 1,104 patients received this valve at~     Rikshospitalet-Radiumhospitalet HF in the period 1977-87. In the present study we followed~     all 816 patients undergoing aortic valve replacement (AVR) over a 25-year period.~   "
234466|NCT00486915|"~     Stroke is a major cause of morbidity in western society, and an infrequent complication of~     cardiac surgery. The majority of thromboembolic strokes arise from the left atrium, in~     particular the left atrial appendage. This study aims to assess the short-term effects of~     left atrial appendage ligation in terms of postoperative clinical and biochemical parameters;~     and the long-term effects of left atrial appendage ligation in terms of stroke incidence.~   "
234467|NCT00486902|"~     Pain control after cesarean delivery is associated with improved breastfeeding and infant~     rooming-in times. In addition, inadequate analgesia leads to elevated plasma catecholamine~     concentrations, which negatively affect every organ system. There is growing evidence that~     ketamine, N-methyl-D-aspartate receptor antagonist, is efficacious when used as an adjuvant~     in postoperative pain control. A 2006 Cochrane Collaboration systemic review and~     meta-analysis concluded, Ketamine in subanesthetic doses….is effective in reducing morphine~     requirements in the first 24 hours after surgery.~      Ketamine's prolonged analgesic effect, despite its short half-life and its use in low doses,~     is theorized to be due to blockade of spinal cord central sensitization. Central~     sensitization is a phenomenon whereby repeated painful stimulus leads to more severe pain~     perception over time despite no change in the intensity of the painful stimulus.Ketamine may~     also prevent the development of acute opioid tolerance. Ketamine's analgesic effects have~     also demonstrated in the obstetric population. Post-cesarean delivery morphine requirements~     in women who received ketamine as part of a general anesthesia technique were decreased.~     Similary, low-dose ketamine in conjunction with bupivacaine-only spinal anesthesia reduced~     postoperative analgesic requirements compared to bupivacaine-only spinal anesthesia and~     bupivacaine-fentanyl spinal anesthesia.~      In the United States, healthy women scheduled for elective cesarean delivery commonly receive~     spinal anesthesia with bupivacaine-fentanyl-morphine. To our knowledge, IV ketamine has not~     been studied as an adjuvant to this regimen in the analgesic management in post-cesarean~     delivery patients. Multimodal therapy for postoperative pain control is widely practiced due~     to the advantage it provides in blocking multiple pain pathways while minimizing side effects~     of each individual pain medication. We hypothesize that low dose intravenous ketamine will~     improve multi-modal post-cesarean analgesia compared to placebo. The purpose of this study is~     to evaluate this hypothesis and study the possible side effects of this regimen in~     combination with bupivacaine-fentanyl-morphine spinal anesthesia.~   "
234468|NCT00486889|"~     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The overall objective of this study is to evaluate the long-term growth and~     development of patients with infantile-onset Pompe disease with alglucosidase alfa before 1~     year of age. Patients will be followed for 10-year period.~   "
234469|NCT00486876|"~     The primary objectives of this study are to evaluate the clinical safety and tolerability and~     to assess the efficacy of 100 mg, 200 mg, and 300 mg BID dextofisopam compared with placebo~     in female outpatients with diarrhea-predominant or alternating irritable bowel syndrome~     (IBS).~   "
234470|NCT00486863|"~     The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the~     mother and developing baby when the mother has schistosomiasis (a type of worm) infection,~     and whether the drug may improve the mother's and baby's health. The usual practice is to~     wait until after a mother has finished breast feeding before giving the medicine.~     Approximately 375 infected pregnant women, ages 18 and over, in endemic villages in Leyte,~     The Philippines will participate. Study volunteers 12-16 weeks pregnant will be given PZQ or~     an inactive pill (placebo) and stay in the hospital overnight. Small blood samples will be~     collected before and after the medication is taken. Three stool and urine samples will be~     taken during a total of 7 study visits. An ultrasound image (picture or outline of the unborn~     baby) will be performed. When the baby is born, a small blood sample will be taken. Mother~     and baby will be followed for up to 8 months before the baby is born and 1 month after.~   "
234471|NCT00486850|"~     Title of Study: A Prospective, Randomized, Multicenter Trial Comparing Synchronized~     Intermittent Mandatory Ventilation (SIMV) vs. Early Extubation to Nasal Intermittent Positive~     Pressure Ventilation (NIPPV) after Surfactant Treatment in Preterm Infants with Respiratory~     Distress Treatment Period (Planned): 7 days Objectives: To compare the impact of early~     extubation [within 120 minutes of birth to Nasal Intermittent Positive Pressure Ventilation~     (NIPPV group) vs. Synchronized Intermittent Mandatory Ventilation (SIMV group) on the~     incidence of mechanical ventilation via endotracheal tube at 7 days of age in 26 to 29 + 6~     weeks gestation premature infants with respiratory distress treated with intratracheal~     Curosurf (poractant alpha) within 60 minutes of birth.~      Secondary objectives include evaluation of overall clinical outcomes at 7 days, 28 days, and~     36 weeks postmenstrual age (PMA) and/or at discharge, complications, safety, and adverse~     events.~      Number of Subjects: 110~   "
234472|NCT00486837|"~     The objective of this trial is to determine the optimal region of the lung for depositing~     Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF).~     The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either~     the deep lung or to the upper airways in a one to one randomization. The study will measure~     how much of the activity of the enzyme elastase is inhibited by AAT.~   "
234473|NCT00486824|"~     Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor.~     This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral~     indomethacin for preterm labor tocolysis in an effort to identify which drug is most~     effective.~      Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to~     receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider~     will be blinded to the identity of the study drug. An abdominal ultrasound will be performed~     in the labor and delivery unit prior to the administration of the tocolytic in order to~     assess fetal position and fluid level, and to document fetal cardiac activity and movement,~     and will be repeated at 48 hours post-randomization. Following randomization, the patient~     will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each~     containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either~     25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6~     hours for 48 hours. Tocolysis beyond 48 hours will not be used.~   "
234474|NCT00486811|"~     The purpose of this study is to evaluate whether tapentadol (CG5503) prolonged-release (PR)~     tablets at doses of 100-250 mg twice daily provide a better pain relief in patients with~     moderate to severe chronic pain due to osteoarthritis of the knee than a placebo (a~     medication without active substance). In addition the tolerability of CG5503 PR will be~     assessed. One third of the patients will receive CG5503 and one third will receive placebo.~     For further comparison one third of the patients will receive oxycodone controlled release~     (CR) at doses of 20-50 mg twice daily which is an active approved pain medication. Please~     note that tapentadol ER (Extended Release) and tapentadol PR (Prolonged Release) are~     identical and used interchangeably. This is due to United States of America and European~     naming conventions.~   "
234475|NCT00486798|"~     The purpose of this study is to compare the efficacy of quetiapine IR, following rapid~     titration versus conventional titration in patients with acute psychosis~   "
234476|NCT00486785|"~     Primary Objective:~        -  To assess the sexual function improvement from baseline to the end of treatment (Week 24~          or premature withdrawal (PW)) with XATRAL 10mg OD.~      Secondary Objective:~        -  To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and~          sexual disorders,~        -  To compare the improvement in sexual function, urinary symptoms and Quality of Life~          among the different regions,~        -  To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of~          the International Index of Erectile Function),~        -  To assess the onset of action of XATRAL 10mg OD,~        -  To assess the peak flow rate improvement (Qmax),~        -  To assess the safety and the tolerability of XATRAL 10mg OD.~   "
234477|NCT00486772|"~     Vascular calcification and endothelial dysfunction (ED) contribute to the development of~     cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a~     non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification~     in CKD patients while the exact mechanism has not been clarified.~      This study was designed to investigate the effect of short-term sevelamer treatment on both~     serum fetuin-A concentrations and ED seen in CKD patients.~   "
234478|NCT00486759|"~     This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in~     combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin~     [doxorubicin], Oncovin [vincristine], prednisone) chemotherapy (R-CHOP) versus rituximab plus~     CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large~     B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with~     R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP~     was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average~     dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles).~   "
234479|NCT00486746|"~     The main objective of the study is to determine whether a supervised lifestyle intervention~     including individualized dietary counseling could be a curative treatment for patients with~     mild OSA.~   "
234480|NCT00486733|"~     The purpose of this study is to determine if adding shock wave therapy to standard-of-care~     wound treatment for traumatic extremity wounds helps them heal faster.~   "
234483|NCT00486694|"~     The purpose of this study was to determine whether the proposed first line treatment for~     falciparum malaria in this region (sulfadoxine-pyrimethamine + artesunate) would be no worse~     a treatment for vivax malaria that the standard vivax treatment of chloroquine. In areas~     where vivax and falciparum malaria co-exist misdiagnosis of vivax malaria as falciparum is~     not unlikely; it is important to know whether adequate treatment will be received in these~     cases.~   "
234484|NCT00486681|"~     The principal objective of this single-center 2-period study is to evaluate the glycemic~     control of in-patients in 3 hospital departments (Diabetology, Cardiology and Pulmonary Care)~     as the rate of capillary blood glucose measurements within a pre-define target range, and to~     compare results during the period I (warning of the Accu-Check Inform glucose meter on~     glucose levels not activated) and period II (warning activated).~   "
234485|NCT00486668|"~     The primary purpose of this study is to determine whether breast cancer tumors respond (as~     measured by pathologic complete response: the absence of microscopic evidence of invasive~     tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide)~     followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients~     with HER2-positive breast cancer. Trastuzumab will also be given to all patients after~     surgery. The study will also evaluate the toxic effects of the chemotherapy combination,~     including effects on the heart, and will determine survival and progression-free survival 5~     years after treatment. Also, the study will look at whether there are gene expression~     profiles in the tumor tissue that can predict pathologic complete response.~   "
234486|NCT00486655|"~     This study proposes to evaluate the ability to reduce the size and number of laparoscopic~     incisions required to perform gall bladder removal by using flexible endoscopic instruments~     introduced through the mouth, into the stomach and through the stomach wall.~   "
234487|NCT00486642|"~     This randomized phase II trial is studying how well giving pazopanib with or without~     bicalutamide works in treating patients with prostate cancer that did not respond to hormone~     therapy. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of~     prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of~     androgens made by the body. Giving pazopanib hydrochloride together with bicalutamide may be~     an effective treatment for prostate cancer.~   "
234488|NCT00486629|"~     The general goal of the present study is to assess the impact of a community-based exercise~     and dietary intervention in pregnant women living in urban areas during and after their~     pregnancy on the reduction of the risks of both diabetes and obesity in mothers and their~     offspring.~      We hypothesize that a community-based lifestyle intervention program during and after~     gestation may improve pregnancy outcomes in terms of reducing the risk of developing obesity~     or type 2 DM in mothers and their children.~   "
234489|NCT00486616|"~     The purpose of this study is to determine whether functional electrical impedance tomography~     is suitable for examination of double-lumen tube placement compared with fibreoptic~     evaluation.~   "
234490|NCT00486603|"~     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     hydroxychloroquine together with temozolomide and radiation therapy may kill more tumor~     cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of~     hydroxychloroquine when given together with radiation therapy and temozolomide and to see how~     well they work in treating patients with newly diagnosed glioblastoma multiforme.~   "
234491|NCT00486590|"~     Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can~     provide a source of many of the required nutrients for premature, newborn infants,~     particularly protein and calories. This product is made from donor human milk from which the~     skim (non-lipid portion) has been separated and then concentrated. A certain amount of the~     lipid content has been added back to achieve higher caloric content within a small delivery~     volume. The product is then pasteurized and filled in small quantities in order to allow for~     the addition of mother's own milk (or, possibly, milk from another donor). The goal of the~     preparation is to achieve an increase of approximately 4 cal/oz of mother's milk and to~     provide a protein level (when mixed with average pre-term milk) of about 3.5-3.8 g/100 Kcal~     of feed.~      The data on Prolact-Plus will be obtained prospectively from infants who will receive human~     milk fortified in this fashion. The data on standard,bovine (cow)-fortified milk will be~     obtained retrospectively from medical records at the participating institutions. While this~     design is not necessarily optimal in this setting, it is an efficient and quick approach to~     evaluating the acute clinical effect of Prolact-Plus. It is anticipated that further studies~     will be conducted that will examine longer-term accounts and possibly do this in a~     controlled, randomized environment.~      The goal of this study is to evaluate the short-term effect of Prolact-Plus fortified human~     milk when compared with bovine-based fortification of human milk on parameters such as growth~     and short-term development, infectious complications and incidence of feeding intolerance in~     a cohort design. Statistically, the study will attempt to evaluate a null hypothesis of~     equivalent results with respect to these parameters between the two types of fortifiers as~     compared with a two-sided alternative (difference between the groups).~      In addition, data will be collected on overall survival and length of stay in the NICU. These~     data will be collected for descriptive purposes, although an attempt will be made to compare~     the findings with those obtained from the bovine-based fortifier.~   "
234492|NCT00486577|"~     The purpose of this study is to determine whether chronic electrical stimulation of the~     primary auditory cortex is effective in the treatment of chronic, severe and intractable~     tinnitus~   "
234493|NCT00486564|"~     There is currently no curative treatment for children with relapsed/refractory neuroblastoma,~     and for these children the 5 year survival rate is <10%. As such, new therapeutic approaches~     are needed to treat these children. This Phase 1 clinical trial is specifically designed to~     test the safety and toxicity of nifurtimox when given in combination with cyclophosphamide~     and topotecan for the treatment of relapsed and/or refractory neuroblastoma . Prior to study~     opening, 3 pediatric patients with neuroblastoma have received nifurtimox in combination with~     this chemotherapy regimen, and all have had significant measurable responses without undue~     toxicity. These case reports, as well as our in vitro and in vivo investigations into the~     biologic effect of nifurtimox on neuroblastoma cells has prompted the development of this~     Phase I study. This Phase I study will involve a dose escalation trial of daily oral~     nifurtimox alone for one 21 day cycle of therapy, followed by continuation of nifurtimox with~     the addition of standard doses of cyclophosphamide (5 days) and topotecan (5 days) for 3~     additional 21 day cycles. Our primary aim is to evaluate the safety of nifurtimox alone and~     in combination with these chemotherapy agents in multiply relapsed/refractory patients. Our~     secondary aim will be to evaluate the pharmacokinetics of nifurtimox as well as treatment~     response.~   "
234498|NCT00486499|"~     hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor~     eradication.~      A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7~     to 9 and/or PSA 10–20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus~     Pd-103 (124 Gy).~   "
234499|NCT00486486|"~     The objective of this crossover, randomized, placebo controlled, double-masked study is to~     compare the short-term (12 weeks) mean 24-hour IOP control and safety of the new fixed~     combination (bimatoprost/timolol, BTFC) given PM with placebo once in the morning, versus~     BTFC given AM with placebo once in the evening versus bimatoprost given in the evening in~     patients with exfoliative glaucoma (XFG).~   "
234500|NCT00486473|"~     To show if one MRI contrast agent is better than another one in the diagnosis of malignant~     breast lesions compared to histopathology~   "
234501|NCT00486460|"~     Pancreatic cancer is an aggressive disease with an extremely poor prognosis. It is the forth~     leading cause of cancer-related fatalities, with an estimated one-year and five-year survival~     rate of 21% and 5%, respectively. Despite recent progress, the median survival time is 6-10~     months for patients with locally advanced disease and 3-6 months for metastatic disease (1).~     The anti-metabolite gemcitabine has become the standard chemotherapy for locally advanced and~     metastatic pancreatic cancer, after demonstrating an improved rate of clinical benefit~     response and an overall survival advantage over 5-FU (2). In addition to its clinical~     effectiveness gemcitabine has a manageable toxicity profile, making it an attractive agent to~     investigate in combination with newer agents. Series of phase III trials were conducted~     examining the efficacy of the combination of gemcitabine and a second cytotoxic agent,~     including 5-FU, cisplatin, oxaliplatin and irinotecan. These gemcitabine doublets~     demonstrated no survival advantage over single-agent gemcitabine (3-6). However, the~     rationale for continuing to study gemcitabine-based combinations remains compelling.~      Curcumin (diferuloylmethane) is a natural compound derived from the rhizome of Curcuma Longa,~     an East Indian plant, commonly called turmeric. It has been shown to possess potent~     anti-inflammatory and anti-oxidative properties, for which it has a long history of dietary~     use as a food additive. Curcumin has also a potent anti-proliferative effects against a~     variety of cancer cell lines in vitro, which stem from its ability to modulate many~     intracellular signal transduction pathways (7). Human phase I-II studies found curcumin to be~     safe, and indicated no dose-limiting toxicity when taken by mouth at doses up to 10 g/day (8,~     9). This data, together with the dismal therapeutic options available for pancreatic cancer~     patients, suggest that curcumin warrants investigation in this setting. Investigators from MD~     Anderson Cancer Center and Rambam Medical Center in Haifa, have recently initiated,~     separately, a phase II study of single agent Curcumin in patients with pancreatic cancer~     (10).~      One of the lessons learned from cancer research in recent decades is that combination~     strategies can provide dramatic improvement in a therapy’s safety and efficacy over~     mono-therapeutic regiments, especially if the combined drugs differ in their mode of action.~     In a recent paper that was accepted for publication we demonstrated, in vitro, the mechanism,~     clinical importance and implications of a novel combinatorial therapy, of celecoxib and~     curcumin, that was discovered in our lab, in inhibiting the growth of several pancreatic cell~     lines. P-34 (expressing high levels of COX -2), MiaPaca (Expressing low levels of COX-2) and~     Panc-1 (no expression of COX -2) cell lines were exposed to different concentrations of~     celecoxib (0-40µM), curcumin (0-20µM) and their combination. In P-34 cells, curcumin~     synergistically potentiated the inhibitory effect of celecoxib on cell growth. The growth~     inhibition was associated with inhibition of proliferation and induction of apoptosis.~      These experiments further demonstrate, for the first time, that the combination effect is~     correlated with synergistic augmentation of apoptosis and involves down-regulation of COX-2~     protein.~      The present study evaluates gemcitabine in combination with curcumin and celecoxib for~     patients with pancreatic cancer.~   "
234502|NCT00486447|"~     To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and~     Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of~     CAD.~   "
234503|NCT00486434|"~     The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon~     calcitonin in the treatment of patients with osteoarthritis of the knee.~   "
234504|NCT00486421|"~     RATIONALE: Rituximab and prednisone may increase the number of platelets in patients with~     immune thrombocytopenic purpura.~      PURPOSE: This phase II trial is studying the side effects and how well giving rituximab~     together with prednisone works as first-line therapy in treating patients with immune~     thrombocytopenic purpura.~   "
234505|NCT00486408|"~     The purpose of this study is to intensively characterize the immune response, particularly~     the T-cell response, to a three-dose regimen of an adenovirus-based HIV-1 vaccine in~     HIV-uninfected adults.~   "
234506|NCT00486395|"~     In Canada each year, there are approximately 800 infants born between 28 and 32 weeks~     gestation. Up to 60% of these infants will require breathing tube placement for Respiratory~     Distress Syndrome or RDS. RDS is a lung disease of prematurity due to a lack of a compound~     called surfactant. The breathing tube is placed as a conduit for placing surfactant into the~     babies' lungs to improve the lung disease. Most babies are then placed on a breathing machine~     or ventilator. Ventilation is not without harm and can be associated with lung damage, delays~     in feeding, increased hospital stay and interruption of bonding. An alternative that does not~     require the presence of a breathing tube is Continuous Positive Airway Pressure (CPAP). We~     will randomize babies to either ventilation or CPAP to try to minimize the length of time the~     baby is kept on respiratory support.~   "
234507|NCT00486382|"~     The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe~     and whether it can or cannot produce a protective response against visceral leishmaniasis~     when injected to healthy subjects.~   "
234508|NCT00486369|"~     The purpose of this study is to expose patients with OA to calcitonin and to determine plasma~     calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin. Also the purpose~     is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral)~     compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of~     different doses/formulations of oral calcitonin compared to placebo.~   "
234509|NCT00486356|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, epirubicin, and carboplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when~     given together with epirubicin and carboplatin in treating patients with progressive,~     unresectable, or metastatic cancer.~   "
234510|NCT00486343|"~     Asthma is a chronic inflammatory disorder of the airways with a variety of inflammatory~     processes contributing to the pathogenesis. The inflammation leads to a state of increased~     airway responsiveness and reversible airway obstruction that causes the recurrent symptoms of~     asthma. Despite the variety of treatments available for asthma, none are curative, and the~     disease continues to place a burden on society in terms of morbidity, reduced quality of life~     (QOL), and ever increasing healthcare costs. The prevalence of asthma continues to increase~     with current data suggesting that since 1980, adult asthma cases have increased by 75% and in~     children under 5 years of age the prevalence has increased by 160%.1 Additionally, studies~     have suggested that the disease severity has been underestimated and that more patients may~     be classified as having moderate to severe persistent disease.2 Inhaled corticosteroids (ICS)~     have been the cornerstone of anti-inflammatory treatment for decades and have been shown to~     improve lung function, decrease symptoms, and reduce asthma exacerbations.3 However, many~     patients are still inadequately controlled despite treatment according to current asthma~     management guidelines and have a significant unmet medical need. Such patients are at high~     risk of serious exacerbations and asthma-related mortality.4 Combining long-acting~     β2-agonists (LABAs) with low dose ICS has been shown to improve asthma control over using~     higher doses of ICS alone. However, LABAs act mainly at the bottom of the inflammatory~     cascade and there are concerns that they may mask underlying inflammation.5 Recently,~     leukotriene receptor antagonists have been added to ICS as second-line therapy in the~     management of asthma. Zileuton has been extensively studied in inflammatory diseases such as~     asthma, in which leukotrienes mediate inflammation.~      The aim of this study is to assess the effect of zileuton controlled-release (CR; 1200 mg~     2-times daily [BID]) on pulmonary function, asthma control, and symptomatic response in adult~     patients with asthma poorly controlled on moderate dose ICS.~   "
234511|NCT00486330|"~     The main purpose of this study is to examine the effect of tipranavir combined with~     ritonavir, medications for the treatment of HIV-infection, on buprenorphine/naloxone (BUP) in~     people who have been receiving the same dose of buprenorphine/naloxone for at least 3 weeks~     before study entry.~   "
234512|NCT00486317|"~     The purpose of this study is to expose patients with OA to calcitonin and to determine plasma~     calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin and 200 IU nasal~     calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin~     (0.6 mg and 0.8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and~     CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral~     calcitonin compared to placebo.~   "
234513|NCT00486304|"~     RATIONALE: Eating a diet that is low in antioxidants may control cachexia in patients with~     oropharyngeal cancer.~      PURPOSE: This randomized phase I trial is studying the side effects of a low antioxidant diet~     in controlling cachexia in patients with oropharyngeal cancer receiving chemotherapy and~     radiation therapy.~   "
234514|NCT00486291|"~     The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to~     placebo in the glycemic management of obese diabetic adults.~   "
234515|NCT00486278|"~     This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.~      The aim of this trial is to evaluate the safety and efficacy of activated recombinant human~     factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.~   "
234516|NCT00486265|"~     The primary purpose of this study is to find out what the maximum tolerated dose is for an~     experimental drug called AZD4877 based on the side effects experienced by patients that~     receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML).~      For enrollment information see the Central Contact information below~   "
234517|NCT00486252|"~     The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over~     3 months. The secondary objective is to study the other efficacy parameters during treatment~     for 3 months~   "
234518|NCT00486239|"~     The purpose of the study is to assess the effects of temporal lobe epilepsy (TLE) on memory~     and emotional functioning. The study will evaluate the known lateralized neurological~     dysfunction(Right TLE versus Left TLE) on emotional verbal and visual memory function. Study~     data will assess the ability of participants with known lateralized neurological dysfunction~     (Right TLE versus Left TLE) to differentially perceive emotional stimuli. Another component~     of the study will evaluate possible changes in memory function for emotionally charged~     material following right or left temporal lobectomy for the treatment of medically~     intractable epilepsy. It is expected participants with known lateralized dysfunction will~     exhibit differential ability to discriminate emotional charged visual and verbal material.~   "
234519|NCT00486226|"~     The objective of the registry is to evaluate the real world safety and performance of the~     CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate~     endovascular coil embolization of intracranial aneurysms.~   "
234520|NCT00486213|"~     RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients~     with cancer. It is not yet known whether pyridoxine is more effective than a placebo in~     preventing hand-foot syndrome in patients with cancer.~      PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works~     compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients~     with cancer.~   "
234521|NCT00486200|"~     A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.~   "
234522|NCT00486187|"~     The purpose of the ROSITEL study is to assess the effects of rosiglitazone, as compared to~     standard oral therapies for diabetes (metformin/sulfonylurea), on inflammatory markers and~     adipokine levels in diabetic patients using an angiotensin receptor blocker (ARB).~      We hypothesize that ARB-treated diabetic patients receiving rosiglitazone will experience~     greater reductions in vascular inflammation and levels of leptin and resistin, associated~     with increased adiponectin levels, compared to a metformin/sulfonylurea regimen, and that~     these benefits will result in part, from greater improvements in insulin sensitivity in the~     rosiglitazone group.~   "
234523|NCT00486174|"~     The purpose of this study is to investigate whether the addition of Methylene Blue to the~     standard treatment of septic shock will reduce vasopressor requirements~   "
234524|NCT00486161|"~     Ghrelin is a GH-secretagogue gastrointestinal hormone that regulates feeding behavior by~     interacting directly with hypothalamic centers in concert with other negative and permissive~     neuromodulators. Ghrelin is involved in controlling energy balance in the short-term and~     long-term, and its levels are inversely related to the degree of obesity, insulin-resistance~     and energy accumulation. Consequently, obesity bears decreased ghrelin levels which increase~     upon weight loss, energy depletion and long-term exercise programs. Nevertheless, the role of~     acute exercise on the secretion of the bioactive component of ghrelin is yet unknown in~     conditions of normal and excessive body weight.~      Our study examines acylated and total ghrelin secretion following a cycloergometric exercise~     test in obese and age- and sex-matched lean subjects to document if ghrelin components change~     as a function of fat accumulation, insulin homeostasis, growth hormone secretion,~     non-esterified fatty acid availability and exercise performance. Our study aims at testing~     the hypothesis that ghrelin components may be regulated by acute exercise, with~     concentrations at the exercise peak being related to acute metabolic homeostasis. Targetting~     this purpose may help to clarify ghrelin involvement in acute conditions unrelated to~     gastrointestinal activities.~   "
234525|NCT00486148|"~     The purpose of this study is to determine the safety and efficacy of an infant formula~     supplemented with a prebiotic component (GOS) in improving the gut microflora balance,~     mimicking that of breast-fed infants.~   "
234526|NCT00486135|"~     The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects~     with solid tumors or lymphoma. Both a capsule and a tablet formulation will be evaluated.~     XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown~     to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.~   "
234527|NCT00486122|"~     The purpose of this study is to test the hypothesis that atomoxetine administered orally,~     once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is~     superior to placebo in children with ADHD.~   "
234528|NCT00486109|"~     This study investigated wearability and usability of the I-PORT™ Injection Port (I-PORT™), a~     new disposable injection port through which prescribed medication is injected subcutaneously~     from a standard syringe or pen. Additional investigation compared subject opinion towards~     using the I-PORT™ device compared to standard injection therapy.~   "
234529|NCT00486096|"~     Many children undergoing surgery for congenital heart disease have had prior operations.~     Re-operative sternotomy carries with it the risk of cardiac injury and the need for emergent~     peripheral cannulation.~      Our first aim is to demonstrate that peripheral arterial cannulation may be lifesaving in~     cases of complicated sternal re-entry in children and that angio-catheters can be utilized~     when vessels are too small for standard cannulas.~      Our secondary aim is to present a case report of successful femoral cannulation in a 5 kg~     child.~   "
234530|NCT00486083|"~     The purpose of the study is to compare atomoxetine hydrochloride and methylphenidate~     hydrochloride in pediatric patients with ADHD.~   "
234531|NCT00486070|"~     This is a retrospective review of charts and echocardiograms of our patients with Total~     Anomalous Pulmonary Venous Connection (TAPVC). The Children's Surgical and non-invasive Echo~     databases will be used to determine all TAPVC patients. Children's Healthcare of Atlanta and~     Sibley Heart Center Cardiology charts and echocardiograms of the TAPVC patients between~     January 1, 2002 and November 26, 2006 will be reviewed. We anticipate approximately 40~     patients.~      We hypothesize that the presence of descending aortic flow reversal correlates with a higher~     morbidity and mortality in TAPVC.~   "
234532|NCT00486057|"~     The purpose of this study is to examine the outcomes of those who have received Daclizumab as~     part of their immuno-suppression protocol following heart transplantation. Literature~     suggests that the time to first rejection episode can be avoided or delayed by using~     induction therapy.~   "
234533|NCT00486044|"~     The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects~     processes related to the development of Alzheimer's disease, including: 1) levels of a~     substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood~     flow in the brain, 3) inflammation in the brain, and 4) cognitive function.~   "
234534|NCT00486031|"~     The objective of the study is to evaluate the long-term safety and tolerability of treatment~     with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or~     who have mildly to moderately active UC.~   "
234535|NCT00486018|"~     This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study~     of the efficacy and safety of intravitreal ranibizumab compared with sham injections in~     patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients~     with BRVO were enrolled at 93 investigational sites in the United States. The study included~     a treatment period (6 months) and an observation period (6 months).~   "
234536|NCT00486005|"~     Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with~     schizophrenia who have been under treatment with olanzapine for at least two months and~     evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent~     adverse events, changes in vital signs, laboratory results and extrapyramidal effects.~   "
234537|NCT00485992|"~     Children's Healthcare of Atlanta (Children's) is collaborating with Child Health Corporation~     of America (CHCA) in the nationwide effort to reduce catheter related blood stream infections~     (BSIs). As well as the human cost, central venous catheter related bloodstream infections~     significantly inflate hospital costs, mainly through increased length of stay in hospital,~     particularly in intensive care (Jones, 2006).~      The Cardiac Intensive Care Unit (CICU) is participating in this initiative by implementing~     the BSI Bundles per the CHCA guidelines. BSI bundles are a group of patient care~     practices designed to reduce BSI infection rates with implementation in patient care areas.~     The bundles include recommendations for central line maintenance including line insertion,~     dressing changes, line accesses, and monitoring for medical necessity. These bundles were~     implemented on January 16, 2006, when the BSI rate in the CICU had peaked at 18.2 (rate of~     infections per 1000 catheter days). The BSI rates historically for the past two years have~     been highly variable (see attached graph for data from Jan. 04 through Oct. 06). The target~     goal is to maintain a rate below 3.7 which has only been realized twice since the January BSI~     bundle implementation.~      Current practice for the care of central lines outlined in the BSI Bundles is based on the~     Centers for Disease Control and Prevention (CDC) guidelines published in 2002. These~     guidelines included important changes to practice involving the use of chlorhexidine (CHG)~     containing products for improved infection prevention. CHG solutions are currently available~     as either 2% or 3.15% chlorhexidine gluconate in a 70% isopropyl alcohol solution.~      The Primary Aim is to determine if CHG is effective as an antiseptic wipe for accessing lines~     to draw blood and administer medications. Compare the effectiveness of CHG containing alcohol~     wipes (3.15% CHG/70% isopropyl alcohol) to plain alcohol in order to determine best practice~     for the CICU.~   "
234538|NCT00485979|"~     The primary objective of this study is to assess the pathological Complete Response (pCR)~     rate by treatment arm (according to Chevallier criteria).~      The secondary objectives are:~        -  to assess in each treatment arm the clinical Response Rate (RR), the rate of breast~          conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety~          and tolerability profile, the pathological Complete Response rate (pCR) according to~          NSABP and Sataloff criteria,~        -  to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab~          in Her2 +ve patients, according to the pCR rate.~   "
234539|NCT00485966|"~     This is a Phase 2, open-label, multicenter, efficacy, safety, and pharmacodynamic study of~     CX-3543 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL).~   "
234540|NCT00485953|"~     Elderly, postmenopausal women with breast cancer on aromatase inhibitors are at increased~     risk of developing bone loss and osteoporosis. We postulate that in elderly, osteopenic~     postmenopausal women who are on aromatase inhibitor therapy, bisphosphonate therapy will (1)~     prevent bone loss at clinically relevant sites, such as the spine and hip and (2) decrease~     bone turnover.~   "
234541|NCT00485940|"~     The purpose of this study is to determine whether prucalopride is safe and effective in the~     treatment of chronic constipation~      Hypothesis:~      Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the~     treatment of patients with chronic constipation and is well tolerated in those patients~   "
234542|NCT00485927|"~     Medical practice & training are inherently stressful situations. However, the effects of~     stress on educational & clinical performance are not well defined. The purpose of the current~     study is to examine the effects of stress on performance of residents in simulated trauma~     scenarios. The hypothesis is: 1) acutely stressful scenarios will be appraised as threat by~     residents and result in elevations of heart rate and salivary cortisol; 2) increased~     subjective & physiological stress will result in impairments in performance; and 3) greater~     stress responses will result in greater clinical impairments.~   "
234543|NCT00485914|"~     To determine if worksite based functional evaluation/intervention provided by occupational~     therapists improves employment outcomes for persons with arthritis.~   "
234544|NCT00485901|"~     The purpose of this study is to compare intramuscular Olanzapine and intramuscular~     Haloperidol in changing of agitation in patients with schizophrenia~   "
234558|NCT00485719|"~     The purpose of this study is to determine the safety and tolerability of XL765. XL765 is a~     new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies,~     inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell~     death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of~     tumor cells.~   "
234559|NCT00485706|"~     Renal patients have an increased risk for cardiovascular complications. There is also~     increased vascular calcification and bone metabolism is similarly abnormal in patients with~     chronic kidney disease.~      In dialysis patients frequent episodes of hypercalcaemia occur. In a healthy bone structure~     those episodes of hypercalcemia are buffered by the bone. The absence of bone buffering~     capacity in dialysis patients can be a mechanism for vascular calcifications.~   "
234560|NCT00485693|"~     Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee~     arthroplasty~   "
234561|NCT00485680|"~     The purpose of this trial is compare the efficacy of olanzapine and Lithium Carbonate in the~     treatment of bipolar disorder, manic or mixed episodes, in Chinese patients.~   "
234562|NCT00485667|"~     A reduction in the postoperative need for opioids to enhance the recovery process and~     increase patient postoperative satisfaction.~   "
234545|NCT00485888|"~     To add to our understanding of the relationship between blushing, symptom severity and~     potential mechanisms that underlie blushing in patients with SP, we propose comparing SP~     patients' vascular responses to topical m-N pre and post treatment with S-citalopram or~     placebo.~      S-citalopram (an SSRI) has been widely used in the treatment of mood and anxiety disorders as~     it has shown efficacy in these patients (Lepola et al., 2003; Stahl et al., 2003; Burke et~     al., 2002; Davidson et al., 2002; Wade et al., 2002). In comparison to placebo, S-citalopram~     has been shown to be effective and well tolerated in those with short and long term SP (Lader~     et al 2004; Montgomery et al., 2003; Kasper et al., 2002). As indicated, responses to the~     blushing exposure will be assessed prior to and following treatment with S-citalopram or~     placebo and at one month following the intervention.~      Levels of prostaglandin will be compared between groups and will also be correlated with~     symptom severity in the clinical groups. Effective psychological interventions that reduced~     the fear of blushing in individuals with social phobia did not lead to a reduction in actual~     blushing during a social test (Mulkens et al., 2001). As such, it is expected that the~     patients' perception of amount of blushing will change following treatment. In addition, we~     are undertaking an investigation as to whether nican topical administration will change~     following treatment to match the pattern seen in healthy controls.~      The objectives are to evaluate the efficacy of S-citalopram 10 to 20 mg once daily (QD) in~     the treatment of social phobia and to determine if treatment outcome is related changes in~     intensity of the vasodilatory response to 10 mM topical m-N. This is a randomized,~     double-blind flexible-dose study evaluating the efficacy, safety and tolerability of~     S-citalopram 10 to 20 mg and placebo in outpatient subjects diagnosed with SP. At the~     screening visit those who are eligible will enter a randomized trial with S-citalopram 10 to~     20 mg and placebo. The study will begin with a single week of S-citalopram 10 mg.~     Subsequently, capsules will be administered in a flexible dose fashion and patients will be~     followed up weekly (biweekly after week 6) and at the clinician's discretion. After the first~     week the patients' dosage will be increased up to a maximum of 20 mg daily. This dose will~     remain fixed after 8 weeks of treatment until week 16.~   "
234546|NCT00485875|"~     The purpose of this study is to assess changes in ADHD symptoms and tolerability of~     medication in children and adolescents switching from a stimulant to atomoxetine.~   "
234547|NCT00485862|"~     The purpose of the study is to compare sertraline and atomoxetine/sertraline combination~     therapy in patients with persistent depressive symptoms.~   "
234548|NCT00485849|"~     The primary purpose of this study is to evaluate the tolerability and effectiveness of~     atomoxetine in the treatment of attention problems, hyperactivity, and impulsivity in~     children with ASD, and secondarily, to evaluate the possible response to atomoxetine on the~     core symptoms of ASD~   "
234549|NCT00485836|"~     This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study~     of the efficacy and safety of intravitreal ranibizumab compared with sham injections in~     patients with macular edema secondary to central retinal vein occlusion (CRVO); 392 patients~     with CRVO were enrolled at 95 investigational sites in the United States. The study included~     a treatment period (6 months) and an observation period (6 months).~   "
234550|NCT00485823|"~     The purpose of this study is to develop the weight management program, which is combined with~     healthy diet, proper physical exercise, and behavior modification, related to patient's~     quality of life. The patients groups are in routine practice with 5-20 mg olanzapine. The~     study results may be utilized for patients who have gained weight on olanzapine and also~     other antipsychotic drugs.~   "
234551|NCT00485810|"~     The purpose of this study is to examine the clinical therapeutic dose in Japanese agitated~     patients with schizophrenia.~   "
234552|NCT00485797|"~     Experimental design overview The proposed project is a prospective experimental study design.~     Children (age <15) suffer from attention deficit hyperactivity disorder (ADHD) that their~     Parents willing to participate in the study will be tested with well-established measuring~     techniques of Balance control before and 1 hour after taking of Methylphenidate (Ritalin) in~     the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to~     extract standardized stabilogram-diffusion parameters from each of the COP data sets~     collected during quiet standing. These parameters include diffusion coefficients, critical~     displacement, critical time and scaling exponents for both lateral and anterior-posterior~     sway directions (Collins & De Luca, 1993). For each of the conditions (before and 1 hour~     after the use of Ritalin) in three task conditions single task; dual task (concentrating and~     identifying specific music); and just Listening to a relaxing music. Participants will be~     required to stand on the platform 10 times for 30 s. For each trial, they will be instructed~     to sway as little as possible.~   "
234553|NCT00485784|"~     This is a prospective multicentric study including four clinical units of Gynecology and~     Obstetrics (3 public health hospitals and one private team), one research team in Hematology~     and one Center of Clinical investigation (CIC).~      The objective is to identify, beside the pregnancy, in a population of patients with a~     preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise~     (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.~      We want to understand better the physiopathology of preeclampsia and propose to patients with~     an endothelial dysfunction a early prevention of preeclampsia.~      Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after~     the birth.~      Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.~      Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to~     medical pregnancy follow up will be invited to participate.~      The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the~     event.~      The study will last 3 years. The number of patient to include is 280.~   "
234554|NCT00485771|"~     The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine~     comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar~     depression.~   "
234555|NCT00485758|"~     A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant~     versus placebo in Type 2 Diabetes Mellitus patients.~   "
234556|NCT00485745|"~     Given the relative lack of information regarding the risks associated with repeat sternotomy~     in the pediatric patient population, a preliminary screen of the Children's Cardiothoracic~     Surgery Database was performed to determine how many repeat sternotomies have been performed~     at this institution within the last 4 years. A total of 1281 repeat sternotomies were~     identified during this time period.~      We propose a retrospective review of the indications, potential risk factors, and short-term~     outcomes for these procedures. These data would allow a multivariable regression analysis to~     identify risk factors associated with adverse events during repeat sternotomy.~   "
234557|NCT00485732|"~     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.~     The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to~     cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK~     Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
234563|NCT00485654|"~     Heterotaxy syndrome is a heterogeneous disease that is the result of a failure of normal~     right-left lateralization of the abdominal and thoracic organs during development. The major~     clinical manifestations include intestinal malrotation, functional asplenia and complex~     cyanotic heart disease.~      Hypothesis: There exists a yet, un-recognized, racial distribution in heterotaxy syndrome.~   "
234564|NCT00485641|"~     The purpose of this study is to determine what the potential utility of the Functional Tone~     Management (F.T.M) Arm Training Program using the SaeboFlex in an inpatient stroke~     rehabiliation hospital~   "
234565|NCT00485628|"~     Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.~   "
234566|NCT00485615|"~     The primary objective is to evaluate the efficacy of an enteric-coated, eicosapentaenoic~     acid-concentrated fish oil in the treatment of social phobia. A secondary objective is to~     determine if treatment outcome is related to plasma phospholipid essential fatty acid status,~     niacin skin flush and measures of lipid/protein peroxidation.~   "
234567|NCT00485602|"~     The trial is aimed to investigate an orthodontic treatment with a new~     removable-part-time-wearing appliance, based on High-Tech technology.~      The appliance should be wear only 12-14 hours a day, and is made of a single silicone~     aligner, made specifically for the patient, using 3-D screening technology of the patient's~     malocclusion. The aligner has a designed pathway built-in for the tooth to move, from the~     original position of the malocclusion to the end point - the correct position.~      The force system, that is needed in order to generate tooth movement, is produced by tiny~     air-balloons which are incorporated in the aligner.~      The study hypothesis is, that an orthodontic treatment can be done successfully with this~     part-time wearing appliance.~   "
234568|NCT00485589|"~     This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in~     combination with methotrexate in patients with active rheumatoid arthritis who are naive to~     methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or~     ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be~     administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5~     mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and~     the target sample size is 500+ individuals.~   "
234569|NCT00485576|"~     This study is to designed to test the role of complement in the late asthmatic response to~     allergen challenge in mild asthma, as an indicator of the possible role of complement in the~     broader asthmatic population.~   "
234570|NCT00485563|"~     This is a Phase 2 clinical trial to collect data on tumor responses produced by folate-hapten~     conjugate therapy (vaccination with EC90 [KLH-FITC] and GPI-0100 adjuvant followed by~     treatment with EC17 (folate-FITC) in combination with low-dose cytokines in patients with~     progressive metastatic renal cell carcinoma. All patients will undergo imaging with the~     investigational imaging agent 99mTc-EC20 (FolateScan) during the screening period to confirm~     eligibility for the treatment portion of the clinical trial.~   "
234571|NCT00485550|"~     The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone~     versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant~     ADHD.~   "
234572|NCT00485537|"~     Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the~     number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical~     pregnancy and miscarriage rates, were analized.~   "
234573|NCT00485524|"~     Mortality after neonatal cardiac repair remains significant, and neonates who have undergone~     operative repair of congenital heart disease may experience sudden and unexpected demise.~     Most of these deaths occur within the first 72 hours and have been attributed to poor~     systemic cardiac output. The literature currently does not define an early and reliable~     predictor of poor post-operative outcome in children with congenital heart disease who have~     recently undergone surgery.~      The investigator wishes to perform a retrospective chart review to independently define the~     predictive values of both NIRS score and serial serum lactate levels in the setting of early~     post-operative morbidity.~   "
234574|NCT00485511|"~     Spinal muscular atrophy (SMA) is an autosomal recessive disorder in humans which results in~     the loss of motor neurons. It is caused by reduced levels of the survival motor neuron (SMN)~     protein as a result of loss or mutation of the SMN1 gene. SMN protein is encoded by two~     genes, SMN1 and SMN2, which essentially differ by an single nucleotide in exon 7. As a~     result, the majority of the transcript from SMN2 lacks exon 7. According to clinical~     severity, SMA was classified to three types, including type I, type II, and type III.~      Drugs capable of modifying the transcription pattern of SMN2 to increase the full-length of~     SMN mRNA expression and the amount of SMN protein may have therapeutic effects for SMA~     patients. In order to test this hypothesis, we used EBV-transformed lymphoblastoid cell lines~     derived from the different types of SMA patients to screen the effect of various drugs on~     SMN2 gene expression. Hydroxyurea (HU) was found to be effective among the drugs we tested.~     HU is an effective therapeutic agent for patients with thalassemia and sickle cell disease~     which the toxicity is minimal and is well-tolerated and safely used in children. We had~     undergone a small-scaled 33 SMA patients randomized pilot trial (HU treatment for 8 weeks and~     then follow up drug-free 8 weeks) to evaluate the effect of HU in SMA patients and we got a~     promising preliminary data. We found that HU could significantly increase in the manual~     muscle testing scores at 4 weeks, and full-length SMN mRNA level in the 30mg/kg/day subgroup~     at 8 weeks relative to baseline, and it is safe under the dose 30mg/kg/day.~      In this study, we plan to enroll 60 type II and III SMA patients and conduct a single-center,~     randomized, double-blind, placebo-controlled, prospective trial of two-year duration to~     evaluate the efficacy and safety of HU.The primary end points are the changes in full-length~     SMN expression, SMN protein, motor function and lung function in SMA patients. We also design~     a safety monitoring system to investigate the adverse effects and to assure the patients'~     safety. We hope we can find and prove the efficacy and safety of HU in SMA patients and set~     up a evaluating model for multi-center trials in the future.~   "
234575|NCT00485498|"~     The purpose of this study is to examine whether olanzapine, compared to risperidone, can~     provide more adequate and timely control of behavioral agitation in acutely ill subjects with~     schizophrenia.~   "
234576|NCT00485485|"~     Primary Objective:~        -  To determine the efficacy of the combination of imatinib mesylate and docetaxel in~          recurrent or metastatic head and neck squamous cell cancer by serial measurements of~          tumor response (extent, frequency, duration).~      Secondary Objectives:~        -  To assess the safety and tolerability of imatinib mesylate and docetaxel in patients~          with recurrent or metastatic head and neck squamous cell cancer.~        -  To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by~          immunohistochemical analysis of microvessel density and phosphorylation of~          Platelet-derived growth factor receptors (PDGF-R).~        -  To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum.~        -  To assess the rate of survival.~   "
234579|NCT00485446|"~     This study was designed to evaluate the incidence of both, inherited and adquired~     thrombophilia, and thyroid autoinmunity in unknown infertility (UI), implantation failure~     (IF) and recurrent miscarriage (RM). To focus on these particular disorders and to rule out~     another potential confounding variables, 4 particular groups of women were created. Only~     young women (< 38 years old), patients whose previous preimplantation genetic screening (PGS)~     cycles displayed an acceptable rate of aneploidies, and women without organic uterine~     abnormality, autoimmune disease or endocrine disorder were included in the study.~   "
234580|NCT00485433|"~     The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of~     bupivacaine HCl.~   "
234581|NCT00485420|"~     The study aim is to explore the effect of a comprehensive Internet-based disease management~     program for bipolar disorder and recurrent or chronic major depression on clinical outcomes~     and satisfaction with care.~   "
234582|NCT00485407|"~     The purpose of this trial is to test the value of dose increases in patients with residual~     ADHD symptoms after treatment with the usual target dose of atomoxetine~   "
234583|NCT00485394|"~     The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic~     solution and drug-free solution to safely and effectively treat geographic atrophy associated~     with age-related macular degeneration.~   "
234584|NCT00485368|"~     The purpose of this research is to assess the effects of a drug called perindopril on the~     aorta in people known to have Marfan Syndrome. The aorta is the major artery of the body that~     comes out of the heart and supplies blood to the body. We know that in people with Marfan~     Syndrome, the aorta is stiff and this stiffness results in its enlargement over many years.~     This enlargement of the aorta can be very serious. We know from treatment of other heart~     conditions that drugs of the same type as perindopril reduce stiffness of the arteries. This~     type of drug has never been tried in people with Marfan Syndrome.~   "
234585|NCT00485355|"~     The purpose of this study is to compare two ways of performing laparoscopic hysterectomy -~     robotic-assisted vs. conventional laparoscopy.~   "
234586|NCT00485342|"~     The aim of this study is to compare two therapeutical strategies concerning the combination~     therapy (peginterferon alfa-2a and ribavirin) in naïve patients with chronic hepatitis C of~     genotype 1. Reference strategy corresponding to standards of care recommended by the French~     consensus conference versus Test strategy corresponding to adaptation strategy of ribavirin~     dose during the first week according to AUC (area under the curve) of ribavirin plasmatic~     concentration after the first intake (Day 0) of 600 mg~   "
234587|NCT00485329|"~     The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability~     and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous~     ulcers patients.~   "
234588|NCT00485316|"~     The aim of the investigators' randomized trial is to compare the short-term clinical outcome~     and survival between laparoscopic-assisted and open resection of colorectal carcinoma.~   "
234589|NCT00485303|"~     The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in~     participants with advanced prostate cancer (a disease in which cells in the prostate gland~     become abnormal and start to grow uncontrollably, forming tumors).~   "
234590|NCT00485290|"~     The reason why esophagus varices suddenly rupture and start to bleed is unclear. Food intake~     increase the hepatic blood flow and the portal pressure, but it is yet unknown if there is~     also an increase in variceal pressure. The aim of this study is to evaluate the efficacy of a~     meal on variceal pressure with a non invasive endoscopic measurement device, and compare it~     with portal pressure.~   "
234591|NCT00485277|"~     The current trial, BNIT-BR-002, will evaluate the safety and biological activity of a fixed~     dose of MVA-BN®-HER2, with and without Herceptin, following 1st- or 2nd-line chemotherapy in~     patients with Her-2-positive metastatic breast cancer.~      The intent of vaccination is to induce anti-Her-2 immune responses, both antibody and T cell,~     that will then attack the Her-2 expressing tumors, and may induce tumor regression or slow~     progression of disease.~   "
234592|NCT00485264|"~     Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral~     replication. Raltegravir is a drug that prevents integrase from working properly. This drug~     has been tested for safety and efficacy in adults, but this is the first study to examine~     raltegravir in children and adolescents. The purpose of this study was to determine the~     appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of~     age, by acquiring short and long term safety data, intensive and population pharmacokinetic~     (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.~   "
234593|NCT00485251|"~     The operation used for treating cancer in this location of the colon is called right~     hemicolectomy. Currently the investigators have two methods of minimal access approach to the~     abdominal cavity in order to complete this operation:~        1. Total Laparoscopic right hemicolectomy The operation is completed by laparoscopic~          instruments using video laparoscopy. At the end of the procedure, a small wound was~          created for the delivery of bowel and extracorporeal anastomosis.~        2. Hand-assisted laparoscopic right Hemicolectomy A 6.5cm incision is used to allow~          insertion of one of the surgeon's hands into the abdomen. The operation is completed by~          the surgeon's hand and laparoscopic instruments, using video laparoscopy.~      These two operations are essentially identical except for the surgical access. Both total~     laparoscopic and Hand-assisted laparoscopic surgery has been practiced in the United States~     and Europe for over 10 years. Studies from the United State and Europe have demonstrated the~     safety and the benefits of both techniques in terms of pain and recovery. In order to find~     out which one is a better procedure, the investigators are carrying out a clinical trial to~     compare the two surgical options in their short-term and long term outcomes.~      The results of this study may have an impact on the care of similar patients in the future.~   "
234594|NCT00485238|"~     The aim is to determine which approach, immediate argon laser peripheral iridoplasty or~     conventional systemic medical treatment efficiently breaks acute angle closure attack without~     consequent visual morbidities. The specific objectives are to see whether sudden intraocular~     pressure(IOP) lowering brought about by laser iridoplasty or medical treatment affects optic~     nerve head structure and function and identify if immediate decompression is associated with~     greater incidence of ocular problems like corneal endothelial compromise, optic disc edema,~     macular edema, decompression retinopathy, cataract formation, progression to chronic angle~     closure.~   "
234595|NCT00485225|"~     Two stage study looking at different titration schedules in patients with moderate to severe~     non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be~     enrolled. Study participation is approximately 3 months.~   "
234596|NCT00485212|"~     purpose: to determine wether a compression bandage prolongs analgesia of local infiltration~     analgesia after total knee arthroplasty~   "
234597|NCT00485199|"~     To undertake a prospective randomized clinical study for treating retinal detachment due to~     myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas~     tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of~     retinal detachment due to myopic macular hole.~   "
234598|NCT00485186|"~     The extend of steroid biosynthesis and action is mainly dependent on underlying genetic~     polymorphisms and gene mutations. These sequence variations in multiple genes involved in~     steroid biosynthesis and action cause different diseases (for example congenital adrenal~     hyperplasia or disorders of sex development). In addition, sequence variations in several~     other genes may influence the severity of a genetically caused disease of steroid~     biosynthesis or action. By this, the differences in an observed phenotype may be explained.~     Within the study all genes necessary for adrenal and gonadal steroid biosynthesis and several~     genes which are known to influence the action of steroid hormones will be analysed in~     patients with congenital disorders of adrenal and gonadal steroid biosynthesis, disorders of~     steroid action and disorders of sex development. The primary aim is to set up a correlation~     of the disease phenotype with the different genotypes detected.~   "
234599|NCT00485173|"~     The purpose of this study is to evaluate the safety and effectiveness of the investigational~     implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of~     facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical~     degenerative disc disease.~   "
234600|NCT00485160|"~     The purpose of this study is to determine whether closure of the PDA in premature neonates~     using IV ibuprofen vs continuous IV indomethacin has different side effects, eg. effects on~     renal function, on blood flow velocity in the superior mesenteric artery, the anterior~     cerebral artery, and the renal artery.~   "
234601|NCT00485147|"~     The maximal walking distance (MWD) performed on treadmill (TT) remains the gold standard in~     estimating the walking capacity of patients suffering from peripheral arterial disease (PAD)~     with intermittent claudication, although treadmills are not accessible to most physicians. We~     hypothesized that global positioning system (GPS) recordings could monitor community-based~     outdoor walking and provide valid information on walking capacity in PAD patients.~   "
234602|NCT00485134|"~     The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal~     vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea,~     dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.~   "
234603|NCT00485121|"~     The purpose of this study is to investigate the effects of adding ezetimibe to statin therapy~     on levels of inflammatory markers and adipokines in patients with atherosclerosis disease and~     features of the metabolic syndrome,whose LDL-c remains above target (> 2.0 mmol/L) despite~     statin monotherapy.~      We hypothesize that the addition of Ezetimibe (10mg per day for 12 weeks) to ongoing statin~     therapy in patients with atherosclerosis and features of the metabolic syndrome will~     favourably modify levels of inflammatory biomarkers and adipokines.~   "
234604|NCT00485108|"~     The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may~     have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will~     evaluate the IOP lowering effect of SLT following the topical administration of one of the~     following: prednisolone 1%, ketorolac 0.5% or artificial tears.~   "
234605|NCT00485095|"~     The purpose of this study is to determine whether supplement of plant sterol could lower~     blood cholesterol.~   "
234606|NCT00485082|"~     This study will examine the experience of disclosing a cystic fibrosis (CF) diagnosis to a~     dating partner. CF has implications for potential life partners (issues of fertility,~     decreased life span and an increasing need for medical management with age) that may make~     disclosure particularly sensitive. An understanding of the disclosure process may provide~     insight into ways health care practitioners can support their patients during this process.~      People between 21 and 35 years of age with CF who have been in at least one dating~     relationship may be eligible for this study.~      Participants are interviewed by telephone about their experiences living with cystic fibrosis~     and telling dating partners about their diagnosis. The interview includes questions about:~        -  Past experiences disclosing their CF diagnosis to a dating partner~        -  What information was disclosed versus what was not disclosed~        -  Why certain information was disclosed or not disclosed~        -  Positive and negative implications of the disclosure or non-disclosure~      The interview lasts about 60 minutes and is tape-recorded for later review and analysis.~   "
234607|NCT00485069|"~     Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease~     (PD) on 20 October 2006.~      ROP is expected to be used for a long term in clinical practice. However, no long-term~     clinical data with ROP administered three times daily are currently available from Japanese~     patients, and the clinical experience with ROP at >10mg/day is limited.~      For this reason, this study was designed as a multicenter open-label uncontrolled study.~      This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating~     Scale (UPDRS), Awake time spent Off/On, Modified Hoehn & Yahr stage, Schwab-England~     scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI))~     and the long-term safety of ROP administered three times daily for in PD patients.~   "
234608|NCT00485056|"~     This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the~     effects of insulin-sensitizing agent pioglitazone, on heart and artery function.~   "
234609|NCT00485043|"~     The purpose of this study was to evaluate the effects of TC for Arthritis on physical~     function, pain, and stiffness in older adults with knee/hip OA. Two hypotheses were tested:~        1. Individuals in the TC group will demonstrate greater improvements in physical function~          compared to control group participants.~        2. Individuals in the TC group will demonstrate greater decreases in pain and stiffness~          compared to control group participants.~   "
234610|NCT00485030|"~     To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting~     stent restenosis.~   "
234613|NCT00484991|"~     The Purpose of this study is to provide patients with hyperphenylalaninemia (HPA) due to~     Phenylketonuria (PKU) access to sapropterin dihydrochloride and to collect more information~     about the safety of the drug in an expanded access program (EAP) until commercial product is~     available.~   "
234614|NCT00484978|"~     Brain metastases (BM) are the most common intracranial tumors in adults and source of the~     most common neurological complications of systemic cancer. Surgery and radiation therapy are~     the most important components in the management of BM with the goal to prolong survival and~     improve the quality of life. Whole brain radiotherapy (WBRT) has shown to increase local and~     distant control both with and without surgical resection. However, patients who develop a new~     or recurrent BM after WBRT and undergo resection are left without adjuvant therapy options.~     Local recurrence particular in patients with single metastasis does effect both survival and~     quality of life. In individual cases the option of additional radiotherapy has been suggested~     and applied. We seek to evaluate the addition of a stereotactic radiosurgery (SRS) boost to~     the resection cavity both as adjuvant and salvage procedure among patients, who undergo~     resection of a BM and previously received WBRT or decline WBRT. Goal is to show superior~     local brain control.~   "
234615|NCT00484965|"~     The purpose of this study is to determine whether erythrocyte mediated dexamethasone delivery~     reduces circulating inflammatory markers after coronary stent implantation and improves~     clinical and angiographic outcomes.~   "
234616|NCT00484952|"~     Objectives~        1. To determine the burden and characteristics of rotavirus-associated hospitalizations~          among children under five years of age of northern Israel~        2. To identify potential risk factors of rotavirus infections associated with~          hospitalizations among Jewish and Arab children younger than five years of age.~      Methods:~      Study design: A two-year prospective study and a nested case control study will be carried~     out Collection of data: Questionnaires will be filled in with demographic characteristics of~     patients and data on the clinical manifestation of the diarrheal episode leading to~     hospitalization. Stool specimens will be systematically collected from all children~     hospitalized because of diarrheal diseases and examined for rotavirus and for bacterial and~     protozoan enteropathogens. Positive samples for rotavirus will be tested for G and P~     genotypes.~      For the nested case control study additional data will be obtained from parents' interviews~     on variables such as: parents' education, parents' age, parents' occupation, no. of siblings,~     age of siblings, breastfeeding etc. to identify potential risk factors for rotavirus diarrhea~     necessitating hospitalization.~      Data analysis: Methods of descriptive statistics / epidemiology will be applied to determine~     the characteristics of the burden of rotavirus-associated hospitalizations (the distribution~     of diarrhea associated hospitalizations by etiology, rates of rotavirus diarrheal diseases in~     Jewish and Arab children, age specific rates of rotavirus infections, the percentage of~     hospitalizations due to rotavirus diarrhea by month, etc.~      For the nested case control study, univariate analysis will be first performed using Student~     t test for continuous variables and chi square test for categorical variables to study the~     statistical significance of predictive factors of rotavirus diarrheal diseases necessitating~     hospitalization. Multivariate analysis using logistic regression models will be performed to~     study the independent effect of each variable. Odds ratios (OR) and 95% CI will be computed~     for each variable. Two tailed p < 0.05 will be considered significant.~   "
234617|NCT00484939|"~     This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination~     with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with~     metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5~     mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000~     mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2~     orally twice a day on Days 1-14 of each 3-week cycle) alone.~      No notable trends or interactions in laboratory values, electrocardiogram, or vital signs~     suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or~     capecitabine monotherapy were observed during the study.~   "
234618|NCT00484926|"~     The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world~     Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic~     Events) trial is to assess the relationship between clopidogrel use and long-term rates of~     cardiac death or MI after DES implantation in real-world practice and to estimate the~     duration of dual antiplatelet therapy for preventing the late thrombotic events.~   "
234619|NCT00484913|"~     We investigated, whether abdominal hot compresses effect hepatic blood flow. Our hypothesis~     was, that the hot compresses might either by local vasomotor-reflex or by decreasing the tone~     of the sympathetic nerve system increase hepatic blood flow.~   "
234620|NCT00484900|"~     The purpose of this open randomised multi-centre clinical trial is to test the hypothesis~     that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine,~     administered over 24 hours is not inferior in efficacy to the same drug administered over 48~     hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine~     As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy~     to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60~     hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum~     malaria.~   "
234621|NCT00484887|"~     This study will collect a large amount of hernia mesh explants and study the changes that~     occur in the materials in vivo to use the information to help design new mesh made from novel~     materials. We will have evidence that our current options are not only inadequate but can~     lead to complications. One of our main goals is to convince our colleagues to change their~     surgical practice by publishing and educating them with this data.~   "
234622|NCT00484874|"~     The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab~     (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what~     side effects these patients get when they take Bexxar® and if Bexxar® is effective in~     treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of~     radiation to cancer cells.~   "
234635|NCT00484705|"~     Hypothesis:~      The overall hypothesis is that women with PCOS, both obese and non-obese, have larger~     adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these~     changes are associated with high sympathetic nerve activity, hyperandrogenism~     hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular~     disease (CVD) as well as psychological distress and reduced quality of life. Physical~     exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare~     menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced~     disturbances.~   "
234646|NCT00484562|"~     Objectives:~      The objective of this study is to determine if any differences exist between the varying~     modes of portable oxygen delivery systems including liquid oxygen, a portable concentrator,~     portable devices filled at home from a concentrator, and medical grade compressed oxygen~     (either an M6 size or D size cylinder).~      Hypothesis:~      Patients who are prescribed LTOT will show similar physiologic responses to exercise when~     using differing modalities of portable oxygen delivery systems.~   "
234623|NCT00484861|"~     African Americans have a higher prevalence of vascular disease than Caucasians. Vascular~     disease can lead to heart attacks, strokes and even amputations. Insulin, a hormone which is~     secreted by the pancreas, affects not only glucose and fat metabolism but also vascular~     disease. Impairment of insulin s ability to remove glucose from the circulation is known as~     insulin resistance. To overcome insulin resistance the pancreas secretes extra insulin. These~     high levels of insulin affect circulating triglyceride levels by both promoting production of~     triglyceride by the liver and interfering with clearance of triglyceride from the~     circulation. Triglyceride in turn contributes to the development of vascular disease by~     causing both inflammation and hypercoagulability.~      Surprisingly African Americans are more insulin resistant and have a higher rate of vascular~     disease than Caucasians but have lower triglyceride levels. Because of the high rate of~     vascular diseases in African Americans, our aim is to determine if the adverse effects of~     triglyceride occur at a lower level in African Americans than Caucasians. To achieve this~     goal we will determine if there are differences in the effect of a meal on triglyceride~     levels and vascular function in a representative cohort of African American and Caucasian~     women.~      For this study we will enroll 96 women (48 African American and 48 Caucasian women). We are~     recruiting women because ethnic differences in triglyceride are even greater in women than~     men. We are enrolling women between the ages of 18 and 65 years. The study will involve~     several outpatient visits to the NIH Clinical Center. The first visit will be a screening to~     determine eligibility. At the second visit a test to measure insulin resistance will be~     performed. This test is called a frequently sampled intravenous glucose tolerance test. The~     third visit will be for the test meal. Before and at 2, 4 and 6 hours after the meal, blood~     will be drawn and vascular function measured. Vascular function is determined by taking blood~     pressure and then measuring blood flow in the arm with ultrasound. It is possible that~     individual differences in diet could affect the results of the vascular study on the day of~     the test meal. Therefore for 7 days prior to the test meal, the NIH Clinical Center will~     provide to each participant all their meals in the form of either trays or meals in a box.~     These meals will be consistent with the typical American diet and be 33% fat, 15% protein and~     52% carbohydrate. In designing these meals, the dietician will take into account individual~     food preferences.~      This study is being performed in collaboration with the Harvard School of Public Health, the~     University of Texas Southwestern Medical Center and Indiana University. Therefore some blood~     drawn during Visits 2 and 3 will be sent coded, without personal identifiers, to each~     institution for analyses.~   "
234624|NCT00484848|"~     Totally implanted venous access ports allow a safe delivery of medication, mainly~     chemotherapy, but are also used for blood sampling. This last procedure is not always~     successful, as it appeared from a nurse's survey in different hospitals in Flanders,~     including the University Hospitals in Leuven, Belgium. In 3 to 29 percent of the attempts,~     blood withdrawal is impaired or not possible, as an intermittent or permanent fact. This is~     in line with international literature data where difficulty in blood draw was noted in 6 to~     26% of port accessions. Partial or total occlusion leads to discomfort for the patient, delay~     in therapy, higher costs and extra nursing time.~      A new port system with a tangential outlet (Vortex port) was designed and according to the~     manufacturer, this shape will allow to cleanse the entire reservoir of the port more~     efficiently and avoid the formation of precipitates of medication or blood that could lead to~     an obstruction of the device. These precipitates are also regarded as a potential risk factor~     for infection.~      However, only one previously published small randomised study addressed the value of the~     Vortex port when compared to conventional access devices: Stevens et al. were able to show a~     reduction in obstruction incidence from 26% to 7% with the use of the Vortex port. The~     incidence of blood withdrawal problems in our experience with conventional ports in~     University hospitals Leuven was 8% thus lower than that reported by Stevens, but this remains~     the most frequent problem faced by care providers and patients.~      With this study, the investigators aim to compare the performance of the tangential outlet~     ports and that of a conventional port in order to assess an eventual functional difference.~   "
234625|NCT00484835|"~     The Hypothesis of this study is that performing total abdominal hysterectomy using the newer~     electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to~     the traditional clamp & suture technique will result in reduction of operating time,~     intra-operative blood loss, post-operative pain.~   "
234626|NCT00484822|"~     Often it is necessary to temporarily discontinue OAT when surgical or other invasive~     procedures are required. However, there is no consensus on the optimal management in these~     situations, and heparin bridging therapy is the current usual practice in these situations.~     No large randomized, controlled clinical trials have been yet performed to evaluate the~     efficacy and safety of a low molecular weight heparins (LMWH) as bridging therapy.~   "
234627|NCT00484809|"~     This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept)~     in an Indian population. It will provide surveillance on a currently approved indication for~     Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients~     with moderately to severely active rheumatoid arthritis.~   "
234628|NCT00484796|"~     Hypothesis: Trigeminus-evoked somatosensory potentials (TRI-SEP) may be used as an~     alternative technique to medianus-evoked somatosensory potentials (MED-SEP) in patients~     undergoing elective carotid surgery.~   "
234629|NCT00484783|"~     NOTES access is safe and feasible in the controlled human setting and comparable to~     standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate~     visualization comparable to laparoscopy.~   "
234630|NCT00484770|"~     The primary hypothesis is that, in patients with advanced heart failure, an outpatient fluid~     management strategy guided by BNP levels and clinical targets will lead to fewer days~     hospitalized or dead over a 3-month period compared to an outpatient fluid management~     strategy using clinical targets alone.~   "
234631|NCT00484757|"~     15 patients with narcolepsy and 15 healthy controls will be included in the study. According~     to a randomized, double-blind protocol they will receive intranasally at night first Orexine~     A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded,~     the cytokine-system and neurocognition characterized.~   "
234632|NCT00484744|"~     The purpose of this research study is to compare pain control effectiveness of two medicines~     and a placebo (a dummy pill that does not contain any pain relieving medication) to see which~     one works better at preventing pain when taken both 1 hour before and 6 hours after~     orthodontic separators are placed. The research hypothesis is that there will be a~     significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that~     this effect will differ for acetaminophen versus ibuprofen.~   "
234633|NCT00484731|"~     The effect of intraoperative infiltration of the operation site with bupivacain on the~     development of chronic pain is the object of our trial. We hypothesize that the occurrence of~     chronic pain in the goup of patients receiving the infiltration will be 50% less than in the~     placebo group receiving normal saline. The study is a randomized controlled triple blinded~     trial with a sequential study design.~   "
234634|NCT00484718|"~     The Purpose of this trial is to evaluate the use of a cross-over trial design in an~     osteoarthritis population. We will determine the inter- and intra-subject variability in~     osteoarthritis (OA) endpoints and evaluate if efficacy can be detected by measuring OA~     endpoints following treatment with 2 different types of analgesics in a crossover study of~     this design.~   "
234636|NCT00484692|"~     Background~      Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are~     notoriously under-evaluated.~      Methods~      We conducted a randomized clinical trial in which we compared a medication, i.e.,~     sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most~     efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic~     intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically~     oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported~     continuous abstinence confirmed by urine cotinine levels below the level of detection (13~     ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all~     interviews conducted at 3, 6, and 12 months.~   "
234637|NCT00484679|"~     The purpose of the study is to see whether treating alopecia areata with injections of the~     corticosteroid, Triamcinolone acetonide 10mg/cc (Kenalog-10), has an impact on the adrenal~     glands.~   "
234638|NCT00484666|"~     Primary objective:~      To estimate the overall clinical response rate (CR, PR, SD) of weekly docetaxel and weekly~     topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer.~      Secondary objectives:~      To access the safety and tolerability of this novel combination chemotherapy regimen of~     weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or~     primary peritoneal cancer~      To estimate the progression free survival (PFS) and overall survival (OS) for women with~     recurrent platinum resistant ovarian or primary peritoneal cancer treated with this weekly~     docetaxel and weekly topotecan.~   "
234639|NCT00484653|"~     This is a prospective multicentric study including six clinical units of Gynecology and~     Obstetrics (5 public health hospital and one private team), one research team in clinical~     microbiology and one Center of Clinical investigation (CIC).~      There is a correlation between premature delivery and bacterial vaginosis. So, the anomalies~     of vaginal flora are a potential target for the campaign against prematurity.~      The main objective of this study is to achieve an objective and reproducible technique of~     identification and quantification by molecular biology of lactobacilla and all the other~     micro-organisms involved in vaginal flora anomalies.~      The secondary objectives are the exhaustive culture of bacteria, the characterisation of~     intermediate vaginal flora and bacterial vaginosis among pregnant woman by PCR targeting the~     ribosomic ADN 16S coupled with clonage techniques.~      The number of patient to include is 1000 (time of inclusions: 24 months). The vaginal smears~     will be realized until 32 weeks of gestation (Max: 3 taking of vaginal smears by patient).~   "
234640|NCT00484640|"~     The study goal is to conduct a randomized controlled trial to compare safety and accuracy of~     dosing based on clinical information including the clinical reason for your taking coumadin,~     your age, gender, your body surface area, and other medical conditions you may have with~     dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing~     variability including genotypes for genes important in Coumadin metabolism and response. The~     hypothesis to be tested by this trial states that:when compared to patients managed with a~     best practices standard-of-care coumadin dosing regimen, patients randomized to coumadin~     dosing based on genetically programmed metabolic capacity and other known clinical and~     environmental factors affecting dose will: 1)show reduced risk of adverse events (using~     surrogate measures of such events); and 2)more rapidly achieve Coumadin dosing.~   "
234641|NCT00484627|"~     This study was designed determine whether use of creatine monohydrate, a dietary supplement,~     can increase skeletal muscle mass and strength and improve the response to progressive~     resistance exercise training in people with HIV infection.~   "
234642|NCT00484614|"~     Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled~     into the study and will undergo both high-resolution positron emission mammographic (PEM)~     imaging and contrast-enhanced magnetic resonance imaging (MRI) of the breast(s). The purpose~     of this study is to determine changes in surgical management resulting from PEM or MRI~     imaging as compared to conventional imaging and to determine if the changes were appropriate~     with histopathology as gold standard.~   "
234643|NCT00484601|"~     This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin.~     It also aims to explore the relationship between EBV DNA and clinical response in patients~     with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.~   "
234644|NCT00484588|"~     Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by~     the bronchoalveolar lavage (BAL) method.~   "
234645|NCT00484575|"~     Inhaled sevoflurane during coronary artery bypass grafting (CABG) reduces postoperative~     Troponin levels and may be associated with improved outcome. A dose-response effect has been~     demonstrated by de Hert et al, with greatest reductions of Troponin when Sevoflurane was used~     during the entire operation, as compared to Sevoflurane during parts of the operation.~      Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. Postoperative~     sedation after CABG is currently achieved with intravenous propofol.~      A new simplified method of administration of isoflurane or sevoflurane has been developed and~     tested by members of the research group. The Anesthetic Conserving Device is a modified~     heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway,~     where it is vaporized in an evaporator rod in the device.~      The primary aim (and primary hypothesis)of the current trial is to examine if postoperative~     sedation with sevoflurane after CABG is associated with improved cardiac outcome, measured as~     reduced levels of Troponin, BNP and reduced incidence of cardiac events, such as atrial~     fibrillation, need for inotropic drugs and myocardial infarction, compared with conventional~     propofol sedation.~      Other end-points of the trial are potential renal (protective) effects measured with cystatin~     C levels, need for dialysis but also measurements of inorganic fluorides in serum, as well as~     environmental aspects of sevoflurane sedation in a Cardiothoracic Intensive Care Unit.~     Furthermore, potential differences in ICU memories and well-being during stay in the~     intensive Care Unit will be investigated via patient questionnaires.~      Besides routine blood sampling, plasma will be saved for later analysis of inflammatory~     mediators (biobank).~   "
234680|NCT00484120|"~     This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion~     Cream versus Placebo in subjects with osteoarthritis of the knee.~   "
234681|NCT00484107|"~     This post-marketing study will provide local safety and tolerance data on the use of~     Premarin® vaginal cream.~   "
234647|NCT00484549|"~     Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease~     allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of~     life threatening manifestations such as an ischemic stroke.~      The purpose of the study is to determinate the prevalence of Fabry disease in a population of~     male patients hospitalized for an ischemic stroke.~      This study, with a screening of Fabry disease, allows the patients to make a precise~     diagnosis of their ischemic stroke and to facilitate the screening of the other members at~     the facility.~   "
234648|NCT00484536|"~     The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in~     patients with relapsing forms of multiple sclerosis~   "
234649|NCT00484523|"~     MRI is a powerful imaging tool used for the precise study of brain morphology (morphometric~     study, tissue study, study of connectivity).~      Isotopic examinations by Single Photon Emission Tomography (SPET) and Positron Emission~     Tomography (PET) are used to explore cerebral perfusion metabolism (99mTc- ECD SPET and 18FDG~     PET), as well as dopaminergic neurotransmission (123I FP-CIT SPET, DATSCAN®).~      These examinations routinely contribute to the clinical diagnosis and surveillance of many~     neurological pathologies (dementias, Parkinson syndromes, epilepsies, concussions, vascular~     pathology, brain tumors, etc.).~      As a result of the original morphological and functional information they provide, these~     examinations are being increasingly included in clinical research protocols involving the~     brain.~      The absolute or relative quantification of anomalies observed, however, can be obtained only~     after comparison to a database of normal subjects.~      The creation of these databases is currently limited by their cost and strictly single center~     nature (physical characteristics of each center's MRI, gamma cameras and PET scanner).~      The aim of this multidisciplinary study is to constitute a standardized database of multimode~     neural imaging (SPET, PET and MRI) to be able to objectively quantify anomalies observed in~     patients, at the scale of a group or an individual, for the diagnosis and surveillance of~     neurological diseases.~      Participants will be paid €350. 60 healthy subjects between 20 and 80 years of age (30 men~     and 30 women) will be recruited over 3 years. 4 examinations will be programmed over 2 days~     (one cerebral MRI, on 18FDG PET, one 99mTc-ECD SPET and one DATSCAN®).~      The strictly single center character of this study is explained by the variability of the~     physical characteristics of the imaging equipment used (MRI, SPET and PET scan) inherent to~     each center.~   "
234650|NCT00484510|"~     This study will look at the impact of ascorbic acid (Vitamin C) on the progression of disease~     in people with CMT1A as compared to volunteers receiving a placebo. This study will assess~     whether is it futile to proceed with a larger, longer-term, placebo-controlled study.~   "
234651|NCT00484497|"~     The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.~   "
234652|NCT00484484|"~     Long-term opioid therapy is commonly administered for the management of severe cancer pain.~     Increasing doses of opioids are titrated against effects until analgesia is achieved or~     intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor~     antagonist, has been reported to improve analgesia in patients with uncontrolled pain~     receiving high doses of opioids. This study aims at determining the effectiveness of ketamine~     as an adjuvant to opioids in relieving cancer pain.~   "
234653|NCT00484471|"~     To compare combination treatment of aripiprazole plus valproate versus valproate alone in the~     prevention of relapse in bipolar I disorder patients with symptomatic remission after 5-6~     weeks open-label acute treatment with aripiprazole plus valproate for manic or mixed episode,~     with or without psychotic features.~   "
234654|NCT00484458|"~     The purpose of this study is to demonstrate that the Wallis System (interspinous process~     implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate~     degenerative disc disease (DDD) of the lumbar spine at the L4-L5 level.~      This study will assess the safety and efficacy of the Wallis® System compared to commercially~     available lumbar TDR with respect to individual subject success rates at 24 months~     postoperative follow-up.~      Study participants will receive all study related test articles and surgical procedures at no~     charge. Please scroll down to the Locations section to find a doctor in your area that is~     participating in this study. If you are interested in participating in this study and do not~     see a doctor in your area, please contact Jose Naveira at jose.naveira@abbottspine.com~   "
234655|NCT00484445|"~     The purpose of this study is to identify acute and chronic medical conditions that are~     identifiable early in the course of critical illness that are associated with transfer to~     another health care facility (versus to home) upon hospital discharge.~   "
234656|NCT00484432|"~     The main objective of the trial is to document the response rate in patients affected by~     metastatic ovarian cancer, treated with NGR-hTNF plus doxorubicin. Safety will be established~     by clinical and laboratory assessment according to NCI-CTC criteria.~   "
234657|NCT00484419|"~     A 16 week open-label study with subjects receiving background metformin monotherapy. 150~     subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open~     label rosiglitazone, or open-label sitagliptin.~   "
234658|NCT00484406|"~     Some Matrix Metalloproteases, proteases degrading the extracellular matrix, play a relevant~     role in structure and stability of atherosclerotic plaques. Atherosclerotic plaques~     triggering acute coronary syndromes show increased expression of MMP-1, MMP-3 and MMP-9.~     Regulation of these MMPs is plaid by genetic polymorphisms, G+/G- at –1563 for MMP-1, 4A/5A-~     at –1612 for MMP-3, and a microsatellite (13-27 CA repeats around –90) for MMP-9.~      It is conceivable that these polymorphisms correlate with the clinical outcome of acute~     coronary syndromes, particularly with those without ST segment Elevation (NSTEACS).~   "
234659|NCT00484393|"~     This is a small study known as a pilot study. This pilot study is being done to see if a~     difference in pain from intramuscular palivizumab injection can be detected if tetracaine a~     topical numbing gel is used compared to no medication (placebo). If a difference is found in~     this pilot study, then a larger study may be done to confirm that there is a difference in~     pain experience.~   "
234660|NCT00484380|"~     Conventional coronary angiography is the recommended procedure in detection of coronary~     stenosis in patients with heart valve disease referred for surgery.The aim of this~     prospective study is to assess diagnostic accuracy of multislice spiral computed tomography~     coronary angiography in patients with heart valve disease referred for surgery.~   "
234661|NCT00484367|"~     The purpose of this study is to compare the effectiveness of two psychosocially-based,~     manual-driven, behavioral modalities. One of these is a standardized version of the~     established modality of Adolescent Group Therapy (AGT), which includes both psychoeducational~     and therapeutic components. The other is a state-of-the-art family therapy approach,~     Transitional Family Therapy (TFT), which integrates management of the current problem with~     exploration of multigenerational issues. Both approaches have been developed to expressly~     target adolescent alcohol problems.~   "
234662|NCT00484354|"~     The purpose of this study is to determine if the incidence of acute renal failure (ARF) in~     high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating~     patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will~     be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal~     saline. The volume of fluid given in each arm of the study is equal. All other interventions~     in those patients will be according to standard cardiothoracic anesthesia protocol at our~     institution.~   "
234663|NCT00484341|"~     The main objective of the trial is to document the preliminary antitumor activity of two~     doses of NGR-hTNF administered either alone or in combination with doxorubicin in locally~     advanced or metastatic soft-tissue sarcoma (STS) patients untreated or previously treated~     with one or more prior systemic regimen.~   "
234664|NCT00484328|"~     The purpose of this study is to determine if the medicines for chronic hepatitis C can be~     taken once daily, instead of twice daily.~   "
234665|NCT00484315|"~     The purpose of the TAXUS PERSEUS Workhorse trial is to evaluate the safety and efficacy of~     the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS®~     ElementTM) for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in~     native coronary arteries of 2.75 mm to 4.0 mm diameter.~   "
234666|NCT00484302|"~     The purpose of the trial is to investigate the effect of specialized treatment of cannabis~     abuse among young people with psychosis. The specialized treatment consists of manualized~     individual treatment and group therapy. It will be compared with the standard treatment,~     which consists of non-specialized, non-manualized treatment. 140 patients will be randomised~     to one of the two treatments, and the investigator(s) will be blinded to the treatment~     received.~   "
234667|NCT00484289|"~     The purpose of this study is to demonstrate the safety of chronic use of abatacept in~     Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071,~     IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX~     intolerance.~   "
234668|NCT00484276|"~     The main objective of the trial is to document the progression free survival (PFS) in~     advanced or metastatic malignant pleural mesothelioma patients treated with NGR-hTNF as~     single agent.~      Safety will be established by clinical and laboratory assessment according to NCI-CTC~     criteria.~   "
234669|NCT00484263|"~     The purpose of this study is to determine whether the daily inhalation of nebulised~     hypertonic saline (6%) will decrease the incidence of pulmonary exacerbations and increase~     the quality of life for people with non cystic fibrosis bronchiectasis.~   "
234670|NCT00484250|"~     Oral lichen planus (OLP) is a chronic inflammatory disorder which causes local~     irritation,discomfort and subsequent poor dentition and discomfort in eating . Various~     treatments have been suggested for OLP but their results are unsatisfactory .Despite the fact~     that steroids have been the main therapeutic choice for many years,some researches have been~     done regarding the efficacy of other medication such as metronidazole and doxycycline.The~     purpose of this study is to determine whether metronidazole and doxycycline are effective in~     the treatment of oral lichen planus and to compare their efficacy with each other.~   "
234671|NCT00484237|"~     This study will compare the safety and efficacy for two regimens of etanercept in patients~     with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly~     regimen and a 50mg once weekly regimen.~   "
234672|NCT00484224|"~     The purpose of this study is to determine wether vitiligo patients have more audiological~     abmnormalities, than the healthy population.~   "
234673|NCT00484211|"~     The main objective of the trial is to document the progression free survival (PFS) in~     advanced or metastatic hepatocellular carcinoma patients treated with NGR-hTNF as single~     agent.~      Safety will be established by clinical and laboratory assessment according to NCI-CTC~     criteria~   "
234674|NCT00484198|"~     This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator~     (Pioglitazone)-controlled, parallel-group study in subjects with type 2 diabetes currently~     sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic~     monotherapy. The total duration of a subject's participation will be approximately 30 weeks,~     including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a~     2-week post-treatment follow-up period.~   "
234675|NCT00484185|"~     To provide safety and effectiveness information of BeneFIX during the post-marketing period~     as required by Korea FDA regulations, to identify any potential drug related treatment~     factors in Korean population including:~      1) Unknown adverse reactions, especially serious adverse reactions; 2) Changes in the~     incidences of adverse reactions under the routine drug uses.~      3) Factors that may affect the safety of the drug 4) Factors that may affect the~     effectiveness of the drug~   "
234676|NCT00484172|"~     The purpose of this study is to screen a pediatric population (ages 2-8) for genes associated~     with childhood obesity.~   "
234677|NCT00484159|"~     Lumbar zygapophysial (facet) joint pain is a common cause of low back pain. Radiofrequency~     (RF) denervation is an effective and low risk treatment of chronic low back pain of suspected~     facet joint etiology. Blocks of the medial branches innervating the joints are commonly used~     to localize the pain and make the diagnosis of facet joint pain.~      There is currently no standard number of diagnostic blocks: zero, one, and two blocks have~     all been utilized. Considering the high false positive and false negative rates of these~     blocks, the cost: benefit ratio has been questioned. No study to date has examined the~     practice of diagnostic medial branch blocks before RF denervation.~      The purpose of this study is to determine the optimal number of blocks before radiofrequency~     denervation. Three groups of patients will be studied. In group I, patients will undergo RF~     denervation based on history and physical exam alone. In group II, patients will undergo RF~     denervation based on a positive response to a single diagnostic block with local anesthetic.~     In group III, patients will undergo RF treatment only after a positive screening block and a~     positive confirmatory block.~   "
234678|NCT00484146|"~     Severe sepsis induces significant changes in expression of insulin- and toll-like receptors,~     cytokines, markers of apoptosis, and activation of t- and b-lymphocytes.~   "
234679|NCT00484133|"~     The purpose of this study is to asses the recovery of organ failure between two resuscitation~     protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation~     guided therapy~   "
234682|NCT00484094|"~     To provide safety and effectiveness information for Rapamune during the post-marketing period~     as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any~     potential drug related treatment factors in the Korean population, such as:~        1. Unknown adverse reactions, especially serious adverse reactions~        2. To assess the incidence of adverse reactions under the routine drug uses~        3. Factors that may affect the safety of the drug (e.g., proteinuria)~        4. Factors that may affect the effectiveness of the drug~   "
234683|NCT00484081|"~     We evaluated the application of surgical testicular exploration with the aid of a microscope~     (MictoTESE) to increase the chances of obtaining sperm in men with impaired sperm production,~     a condition known as non-obstructive azoospermia.~      We also evaluated the outcomes of these couples when the sperm obtained were used in ICSI~     (Intracytoplasmic Sperm Injection) during assisted reproductive technology treatment.~      We believe that excellent results may be obtained with the use of the following techniques in~     the treatment of couples where non-obstructive azoospermia is a significant cause.~   "
234684|NCT00484068|"~     Diabetic nephropathy (DN) is a chronic diabetic complication and affects up to 40% of~     patients. The first line treatment for DN is angiotensin blockers drugs that are used to~     reduce the protein concentration in urine.Previous data showed that this protein, namely~     albuminuria, could also be reduced in a short term-period by the replacement of red meat in~     the diet with chicken. The aim of this study is to compare the effects of this chicken diet~     with enalapril on albuminuria in a long-term period( 12 months)in type 2 diabetic patients.~   "
234685|NCT00484055|"~     The aim of the present study is to evaluate a new technique for prevention of sternal wound~     infection consisting of local application of collagen-gentamicin in addition to routine i.v.~     antibiotic prophylaxis.~      The technique has been evaluated in a previous randomised study. The aim of the present study~     is to evaluate the technique after it has been introduced in clinical practise to monitor the~     bacterial antibiotic susceptibility and to verify that the suggested reduction in sternal~     wound infection still exits.~   "
234686|NCT00484042|"~     Background: Polyamines are essential compounds in all mammalian tissues. If tissue~     spermidine/spermine levels, however, dramatically decrease, the cellular survival is severely~     endangered. Transgenic animals, where the homeostasis of cellular polyamines can be disturbed~     and tissue spermidine/spermine levels are decreased, acute pancreatitis evolves, indicating~     pancreas to be one of the most vulnerable organs for tissue polyamine catabolism. On the~     other hand, our own data suggests that also in other models of acute experimental~     pancreatitis pancreatic polyamines are changed depending on the severity of pancreatitis in~     such a way that the more severe pancreatitis the lower are the pancreatic polyamine levels.~     Minor changes were observed also in rats undergoing sham operation only. In addition of~     pancreatic enzymes, inflammatory mediators are also involved in the pathophysiology of the~     disease. CRP, IL-6, IL-8, IL-10 and Procalcitonin are useful in predicting the severity of~     the disease, combination of IL-6 and IL-10 at admission can predict organ failure with~     sensitivity of 95 %, specificity of 88 %.~      Hypothesis: Similar to experimental pancreatitis, blood polyamine changes are associated with~     acute pancreatitis also in the man. These changes are dependent on the severity of~     pancreatitis, but not on the etiology of pancreatitis. The changes are specific to acute~     pancreatitis compared with other intra-abdominal emergencies. The changes observed return to~     baseline during recovery. Furthermore, we assume that blood polyamine negatively correlates~     with IL-6, IL-8, and procalcitonin, and positively with IL-10.~   "
234687|NCT00484029|"~     This purpose of this study is to evaluate the safety and efficacy of treatment with nasal CO2~     in the treatment of pain and other symptoms related to temporomandibular disorder (TMD).~   "
234688|NCT00484016|"~     There are limited numbers of retrospective studies showing the effectiveness of adjuvant~     chemotherapy over observation in resected lung cancers.~   "
234689|NCT00484003|"~     The study will evaluate the safety and effect of pimecrolimus cream 1% on quality of life of~     caregivers of South African children with mild to moderate atopic dermatitis (AD).~   "
234690|NCT00483990|"~     The main objective of the study is to determine the safety and tolerability of repeated~     application of PSD502 to the glans penis in healthy male volunteers~   "
234691|NCT00483977|"~     The primary aim is to assess if PF-00592379 is able to reduce pain in patients with~     osteoarthritis of the knee.~   "
234692|NCT00483964|"~     The purpose of this study is to determine whether a herbal combination of water based~     extracts of Bacopa monnieri(BM) and Nardostachys jatamansi(NJ) is effective in the treatment~     of Schizophrenia.~      The working hypothesis for this study is that a herbal combination of BM and NJ will be as~     effective as modern anti-psychotic drugs, in the treatment of Schizophrenia, and will be safe~     for long term use.~   "
234693|NCT00483951|"~     This study will evaluate volunteers 18 years of age and older to see if they qualify for one~     of NHLBI s research studies. Tests include the following:~        -  General medical evaluation, which may include blood tests, chest x-ray,~          electrocardiogram (ECG) and echocardiogram (heart ultrasound).~        -  Other tests as appropriate, such as magnetic resonance imaging (MRI), cardiac computed~          tomography (CT scan of the heart), nuclear stress test and echocardiography stress test.~        -  X-ray contrast studies of the heart and blood vessels. (These may be excluded in~          patients with kidney risk factors.)~   "
234694|NCT00483938|"~     This study will compare the efficacy and safety of treatment with pegylated-interferon~     alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study~     treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than~     or equal to (>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive~     pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400~     milligram [mg]) orally daily for the specified duration, followed by 24 weeks of~     treatment-free follow-up. Participants with detectable HCV-RNA and less than (<) 2 log10 drop~     in HCV-RNA at week 12 will discontinue therapy.~   "
234756|NCT00483119|"~     The purpose of this study is to compare two standard treatments for pemphigus to determine~     which more effectively improves the clinical manifestations of the disease and decreases~     serum level of the autoantibodies which cause the disease.~   "
235549|NCT00472472|"~     The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the~     efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis~     after femoropopliteal angioplasty.~   "
234695|NCT00483925|"~     Langerhans-cell histiocytosis (LCH) is a rare disease with features of chronic inflammation~     and hypopituitarism, conditions associated with increased risk of cardiovascular diseases.~      Objective: To investigate glucose and lipid metabolism, insulin resistance, structural~     arterial and functional endothelial properties in patients with multisystem LCH in a~     prospective, observational study.~      Interventions:Cardiovascular risk factors: arterial blood pressure, lipid profile,~     mathematical indices of insulin resistance (IR), intima media thickness, brachial artery flow~     mediated dilatation, dynamic indices of IR, pituitary function and C-reactive protein will be~     estimated in patients with LCH and in a control group matched for gender, age, BMI and~     smoking habits.~   "
234696|NCT00483912|"~     The incidence of acute pancreatitis has been doubled during last three decades in Finland.~     Alcohol is the main cause of acute pancreatitis in Finland accounting for 70 % of cases.~     Although the mortality of acute pancreatitis has been decreased it still appears and~     especially early multiple organ failure is the main cause of all deaths. Multiple organ~     failure in the early course of the disease is thought to be caused by the release of~     cytokines. Molecular adsorbent recirculating system (MARS) has shown to decrease mortality in~     acute alcohol hepatitis and paracetamol intoxication. Also it has been shown to improve~     kidney function due to hypoperfusion and tubulus necrosis and overrule decrease mortality in~     patients with multiple organ failure due to different reasons. A part of patients with acute~     alcoholic pancreatitis may have so-called fat liver already on admission. It has been shown~     that the highest mortality is especially associated those with early liver and kidney~     failure. MARS treatment has never earlier been used in the patients with acute alcoholic~     pancreatitis and early organ failure. In this study we randomize patients with acute~     alcoholic pancreatitis and early multiple organ failure (Sofa score>2) to two groups: 1)~     Standard pancreatitis treatment in intensive care unit and 2) Standard pancreatitis treatment~     in intensive care unit with 5 MARS sessions.~   "
234697|NCT00483899|"~     This study was designed to look at safety aspects and effects of repeat inhaled doses of~     GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic~     obstructive pulmonary disease (COPD)~   "
234698|NCT00483886|"~     The purpose of this study is to determine whether prucalopride is safe and effective in the~     treatment of chronic constipation.~      Hypothesis:~      Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the~     treatment of patients with chronic constipation and is well tolerated in those patients.~   "
234699|NCT00483873|"~     The purpose of the study is to collect EEG's as close to the cardiac arrest as possible using~     a standard hospital EEG machine and an investigational EEG device to help determine the~     neurological status of the cardiac arrest patient and to help decide on possible treatment~     and chance of recovery. The investigational EEG machine will be simple to operate as well as~     easy to interpret for the clinician and the nurses. It is not to replace the~     electrophysiologist interpretation but to determine ealy on if further evaluation and~     treatment can help the patient.~   "
234700|NCT00483860|"~     To determine the effect of renal impairment and prior platinum-based chemotherapy on the~     safety and blood levels of topotecan administered orally~   "
234701|NCT00483847|"~     The primary objective of this study is to determine the incidence and pattern of serious~     infections, malignancies, and other serious adverse events (SAEs) in participants with~     multiple sclerosis (MS) treated with TYSABRI (natalizumab).~   "
234702|NCT00483834|"~     Bevacizumab has recently been shown to improve survival when combined with chemotherapy in~     patients with previously untreated metastatic colorectal cancer. Bevacizumab is usually given~     together with infusional 5-FU, which requires a central line. A central line is inconvenient~     for patients, and may increase risk of infection, and thrombosis. Furthermore, a central line~     increases resource demands for interventional radiology, chemo daycare. Capecitabine is~     administered orally, and converted to 5-FU intracellularly. Chronic administration of~     capecitabine mimics infusional 5-FU. This study is designed to evaluate whether the~     combination of irinotecan, capecitabine and bevacizumab is effective as a first-line therapy~     for patients with metastatic colorectal cancer.~   "
234703|NCT00483821|"~     RATIONALE: Gathering disease-related information from medical charts of patients with primary~     head and neck cancer who have undergone neck dissection after complete response to~     chemotherapy and radiation therapy may help doctors learn more about the disease and find~     better methods of treatment.~      PURPOSE: This clinical trial is evaluating the medical charts of patients with primary head~     and neck cancer who have undergone neck dissection after complete response to chemotherapy~     and radiation therapy.~   "
234704|NCT00483808|"~     To investigate the clinical utility of renal denervation in the treatment of refractory~     hypertension.~   "
234705|NCT00483795|"~     To evaluate corneal staining after contact lens instillation with two different multi purpose~     solutions.~   "
234706|NCT00483782|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving~     carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and~     paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer,~     or primary peritoneal cavity cancer.~      PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab~     to see how well they work compared with carboplatin and paclitaxel alone in treating patients~     with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal~     cavity cancer.~   "
234707|NCT00483769|"~     Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by~     glucose derangements~   "
234757|NCT00483106|"~     Attention deficit with hyperactivity disorder (ADHD) is a very common behavioral problem~     during childhood. It is estimated that up to 80% of this disorder could be related to genetic~     factors. The most common treatment for ADHD is psychostimulants. In this study, the~     researchers investigate the effect of genetic variants in increasing the risk for behaviours~     pertinent to ADHD or in modulating the response of these behaviours to methylphenidate.~     Response to methylphenidate is evaluated through a double blind placebo controlled one week~     study.~   "
234708|NCT00483756|"~     A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune~     system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this~     research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant~     patients for 12 months. Patients will be assigned to one of three treatment groups after~     receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing~     regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be~     a standard-of-care control arm. Patients will continue to take the assigned study medication~     for 12 months as well as other standard transplant medications such as prednisone.~   "
234709|NCT00483743|"~     This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated~     nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x~     6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood~     cells and cytokines will also be studied.~   "
234710|NCT00483730|"~     To assess clinical efficacy and safety of Actovegin in type 2 diabetic patients with~     symptomatic diabetic peripheral polyneuropathy after 250 ml i.v. infusions once daily for 20~     days followed by oral treatment 600 mg × 3 daily for 140 days.~   "
234711|NCT00483717|"~     The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute~     treatment of migraine.~   "
234712|NCT00483704|"~     The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in~     acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this~     study are that telcagepant is superior to placebo, as measured by the proportion of~     participants who have pain freedom, pain relief, pain freedom consistency, pain relief~     consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.~   "
234713|NCT00483691|"~     1. Children in the home intervention group will have better growth (increase in weight and~          height) than children in the control group.~        2. Children in the home intervention group will have better behavior than children in the~          control group.~        3. Children in the home intervention group will have better academic performance than~          children in the control group.~   "
234714|NCT00483678|"~     RATIONALE: A couples therapy program may enhance intimacy and reduce psychological distress~     in patients with prostate cancer and in their partners.~      PURPOSE: This randomized clinical trial is studying how well couples therapy enhances~     intimacy and reduces psychological distress in patients with advanced or recurrent prostate~     cancer and in their partners.~   "
234715|NCT00483665|"~     After endovascular treatment of an abdominal aortic aneurysm, lifelong imaging follow-up is~     needed to monitor the effectiveness of the treatment. One parameter in this follow-up is~     endoleak, which is leakage of blood into the aneurysm sac. The aim of this study is to~     investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for~     the detection of endoleaks.~   "
234716|NCT00483652|"~     The purpose of the study is to show that individuals treated with Fampridine-SR tablets are~     significantly more likely to have consistent improvements in their walking than those treated~     with placebo tablets.~   "
234717|NCT00483639|"~     RATIONALE: Patients who undergo treatment for head and neck cancer may become anxious and~     avoid contact with other people. Learning how cancer treatment may cause anxiety in patients~     with head and neck cancer may help improve the quality of life in these patients.~      PURPOSE: This clinical trial is studying anxiety and avoidance of others in patients~     previously treated for head and neck cancer.~   "
234718|NCT00483626|"~     The purpose of this study is to determine the clinical, functional and hemodynamic response~     after six months of sildenafil 50 mg TID in patients with pulmonary arterial hypertension.~   "
234719|NCT00483613|"~     -  Daily stress can worsens the clinical course of lupus.~        -  Objective: to determine the efficacy of the stress management therapy in a group of~          patients with lupus.~        -  45 patients with lupus and high daily stress participated in this clinical trial.~        -  Two groups resulted: a control group (CG) that received the usual care and a therapy~          group (TG) that received a cognitive behavioral therapy.~        -  The therapy consisted of ten consecutive weekly sessions.~        -  The measured variables were psychological, clinical, immunological and quality of life.~          At the basal moment and after 3, 9 and 15 months.~        -  Statistical analysis showed a significant reduction in the levels of depression, anxiety~          and daily stress in the therapy group, compared to the usual care group, a significant~          improvement in quality of life, improvements in the reported symptoms (cardiovascular,~          respiratory, cutaneous and musculoskeletal.~   "
234720|NCT00483600|"~     To determine the appropriate dose and safety of a preventative dose of fondaparinux, an~     anticoagulant medication (blood thinner) in patients with kidney disease.~   "
234721|NCT00483587|"~     Rationale: A safety and dose defining study in which the investigators hypothesize that in~     patients with acute coronary syndrome without ST-elevation (NSTEMI) treatment with heme~     arginate results in better clinical outcome by inducing the heme oxygenase-1 (HO-1) pathway.~      Objective: 1) Is induction of HO-1 and its degradation products, especially bilirubin, safe~     in patients with an acute coronary syndrome without ST-elevation; 2) What is the optimal~     effective dose to administer in patients with NSTEMI; 3) Are HO-1 and its degradation~     products endogenously activated in patients with acute coronary syndrome; 4) Does treatment~     with heme arginate result in a less cardiac damage; 5) Which other cardioprotecting pathways~     are activated by administration of heme arginate?~      Study population: Male and female patients with confirmed acute coronary syndrome without~     ST-elevation, between 18 - 80 yr old.~      Intervention: 10 patients receive a single administration of heme arginate (3 mg/kg),~     administered intravenously in 15 minutes directly after admission; 10 patients receive two~     administrations of heme arginate (3 mg/kg) on day 0 and 1; 10 patients receive three~     administrations of heme arginate (3 mg/kg) on day 0, 1 and 2 after admission, administered~     intravenously in 15 minutes. To determine endogenous levels of HO-1 and time course of HO-1~     activation after NSTEMI, blood is drawn and the same assays are performed in 15 patients with~     NSTEMI. As controls for the blood tests, blood is drawn and the same assays are performed in~     15 patients with non-typical angina pectoris in whom no cardiac disease could be detected~     from the investigators out-patient clinic.~      Main study parameters/endpoints: The primary endpoint is the incidence rate of adverse events~     between the three treated groups. This includes hemodynamic monitoring, rhythm monitoring and~     biochemical and hematological difference between the three treated groups. Secondary~     endpoints are the differences from baseline between heme arginate treated groups in activity~     of the HO-1 pathway, including, but not limited to, HO-1 activity, free heme, bilirubin~     (direct and indirect) levels, serum ferritin, and carbon monoxide (CO). Furthermore,~     differences between heme arginate treated groups on NTproBNP, CK-MB and Troponin T and~     difference between heme arginate treated subjects in LVEF measured by echocardiography, 3 and~     7 days and 6 months after NSTEMI.~   "
234722|NCT00483574|"~     This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in~     subjects at 9 months and at 12 months of age when the second dose is given concomitantly with~     other pediatric vaccines routinely administered in the US.~      Safety Objective:~      To describe the safety profile of two doses of Menactra® Vaccine.~   "
249519|NCT00286468|"~     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily~     (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.~   "
234723|NCT00483561|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as etoposide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving gefitinib together with etoposide~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gefitinib together with etoposide~     works in treating patients with advanced prostate cancer that did not respond to hormone~     therapy.~   "
234724|NCT00483548|"~     The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood~     stabilizer is safe and effective in the short term treatment of Bipolar I Depression.~     Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on~     a therapeutic dose of one of these mood stabilizers for at least 4 weeks.~   "
234725|NCT00483535|"~     GW273225 is in development for epilepsy and bipolar disorder and can affect women of child~     bearing potential. A clear understanding of the potential interaction between oral~     contraceptives and GW273225 is therefore important for clinical investigation of GW273225 in~     a large number of patients. This study will investigate whether there is any effect of~     GW273225 upon the components of combined oral contraceptive, and also whether taking oral~     contraceptives affects the pharmacokinetics (PK) of GW273225.~      26 healthy female subjects, aged 18-45 years will take an oral contraceptive (150ug~     levonorgestrel and 30ug ethinylestrdiol; The study will include a screening period, two~     cycles on oral contraceptive with GW273225 at 25 mg once per day administered from the start~     of the second COC cycle for 47 days. There will be a follow-up visit 14-21 days later.~   "
234726|NCT00483522|"~     This study seeks to determine if telephone counseling improves the outcome for persons with~     moderate to severe traumatic brain injury (TBI).~   "
234727|NCT00483509|"~     The main objective of the trial is to document the progression free survival (PFS) in~     advanced or metastatic SCLC patients affected by advanced or metastatic small cell lung~     carcinoma (SCLC) previously treated with at least one therapeutic regimen~   "
234728|NCT00483496|"~     Commercially available external photoprotectors (EP) do not provide adequate protection~     against ultraviolet A (UVA) and visible wavelengths. The proposed medicinal product V0096 CR~     (formula RV3131A-MV1166) is a broad spectrum EP (bsEP). The rationale for the use of V0096 CR~     (formula RV3131A-MV1166) in the proposed condition is based on its ability to broadly block~     the UVA radiations and visible light that are known to trigger solar urticaria (SU).~   "
234729|NCT00483483|"~     The objective of this study is to test in a randomized controlled trial the effectiveness of~     a US secondary HIV prevention program to reduce HIV risk behaviors, STD acquisition, and~     alcohol consumption among HIV-infected Russians with risky drinking.~   "
234730|NCT00483470|"~     As per request by the Heath Authorities, the present clinical study will assess the~     immunogenicity and safety~   "
234731|NCT00483457|"~     RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer~     receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the~     effects of EGFR inhibitor therapy in the skin.~      PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of~     cancer patients.~   "
234732|NCT00483444|"~     The purpose of this study is to see whether providing education and counseling after a mild~     traumatic brain injury will help in preventing symptoms from becoming chronic over the first~     six months after injury.~   "
234733|NCT00483431|"~     Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular~     health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins,~     Menaquinone-7 (MK7) has been identified as the most effective cofactor for the carboxylation~     reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains~     which dosage of MK7 leads to optimal carboxylation levels of these proteins.~      The primary objective of this double-blind randomized intervention study is to establish the~     optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone~     and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at~     which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.~   "
234734|NCT00483418|"~     The purpose of this study is to survey the total serum testosterone levels in male patients~     with hormone-independent malignancies. The prevalence of hypogonadism is not known, but is~     thought to be significant. Results will be adjusted for age and stratified for type of~     cancer, stage, study site,and presence of opiate use for pain management, which is known to~     reduce testosterone levels.~   "
234735|NCT00483405|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy~     together with a monoclonal antibody may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine~     together with cetuximab works in treating patients with advanced liver cancer.~   "
234736|NCT00483392|"~     The purpose of this study is to evaluate and compare the effects of treatment with~     rosiglitazone and metformin on insulin resistance in patients infected with Human~     Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease~     Inhibitor after the period of 48 weeks.~   "
234737|NCT00483379|"~     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The objective of this exploratory study is to evaluate the safety and~     efficacy of alternative dosing regimens of alglucosidase alfa in patients with Pompe disease~     who have not demonstrated an optimal response to the standard dosing regimen of 20 mg/kg~     every other week after a minimum of 6 months treatment immediately prior to study entry.~   "
235658|NCT00471029|"~     The purpose of this study is to compare the gastric acid suppression profile among different~     regimen (Oral Vs Intravenous)of administration of proton pump inhibitor - Esomeprazole by~     24hours intragastric pH monitoring.~   "
234738|NCT00483366|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and~     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving imatinib mesylate together with gemcitabine~     and capecitabine may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine and~     capecitabine when given together with imatinib mesylate in treating patients with advanced~     solid tumors.~   "
234739|NCT00483353|"~     The current study will investigate nasal inflammatory markers obtained by filter paper~     collection techniques, in subjects with allergic rhinitis, determining the most appropriate~     time points and handling conditions, prior to running a larger study with subjects with~     allergic rhinitis.~   "
234740|NCT00483327|"~     The purpose of this trial is to study the efficacy, toxicity, and tolerability of a standard~     hormonal regimen of Megestrol Acetate (Megace) in the treatment of Atypical Endometrial~     Hyperplasia or well to moderately differentiated endometrial carcinoma.~   "
234741|NCT00483314|"~     The purpose of this study is determine if oral N-acetylcysteine is effective in lowering~     homocysteine in individuals with homocystinuria.~   "
234742|NCT00483301|"~     The purpose of this study is to compare the effects, good and/or bad, of Carboplatin and~     ABI-007 (Abraxane) in combination with Sorafenib (BAY 43-9006) on Melanoma.~   "
234743|NCT00483288|"~     RATIONALE: Written educational materials and counseling by phone may help promote follow-up~     care in women with abnormal Pap smears.~      PURPOSE: This clinical trial is studying how well written educational information and phone~     calls work in increasing follow-up care in Hispanic women with abnormal Pap smears.~   "
234744|NCT00483275|"~     Objective of the study is to evaluate the effect of a multimodal therapy on the basis of~     current guidelines on fall prevention consisting of a 12-months intervention with~     Alfacalcidol and calcium, patient education and a mobility program in a group of patients 65~     years of age or older with an impaired renal function in comparison to a group receiving~     usual care.~   "
234745|NCT00483262|"~     The purpose of this research study is to determine the safety of CCI-779 (Temsirolimus) and~     bortezomib (Velcade), and the highest dose of this drug that can be given to people safely.~     We will also be looking at how the combination of the two drugs may work against multiple~     myeloma. CCI-779 (Temsirolimus) is a drug that appears to stop myeloma cells from growing.~   "
234746|NCT00483249|"~     This is a study to assess the safety and effectiveness of endovascular treatment of~     thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The~     investigational operation involves placing a stent-graft over the aortic aneurysm.~   "
234747|NCT00483236|"~     -  Chronic severe mitral regurgitation can lead to symptoms and left ventricular~          dysfunction.~        -  The purpose of this study is to prospectively follow patients with non-ischaemic~          cardiomyopathy who are eligible for mitral valve repair surgery and primarily measure~          the quality of life through the Minnesota Living with Heart Failure Questionnaire & the~          Kansas City Cardiomyopathy Questionnaire.~   "
234748|NCT00483223|"~     The purpose of this research study is to :~        -  Determine how effective cisplatin or carboplatin is in slowing the time it takes for ER~          negative (estrogen-receptor-negative), PR negative (progesterone receptor-negative),~          HER2 negative (human epidermal growth factor receptor 2) breast cancer to progress.~          Cisplatin and carboplatin are anti-cancer chemotherapy drugs that stop cancer cells from~          growing abnormally and is used to treat other cancers.~        -  Evaluate a new biomarker to help determine which breast cancers are most likely to~          respond to cisplatin chemotherapy~      The hypothesis is that Triple Negative metastatic breast cancer may be particularly sensitive~     to platinum, and that a subgroup of those patients may have a marker in their tumors that~     predicts response.~   "
234749|NCT00483210|"~     Resistance to the hypoglycemic action of insulin develops within 7 days of bedrest in young,~     healthy volunteers. We propose that the same event occurs in elderly individuals confined to~     bed, that alterations in lipid metabolism are, at least in part, responsible for the insulin~     resistance associated with bedrest, and that the accumulation of intracellular triglyceride~     (TG) in liver and muscle will play a role in impairing insulin action. Further, we propose~     that the PPARα (Peroxisome Proliferator-Activated Receptor Alpha) agonist fenofibrate will~     increase tissue fatty acid disposal by activating mitochondrial oxidative capacity, thereby~     improving insulin sensitivity.~      We will investigate a series of specific hypotheses designed to examine the role of altered~     lipid metabolism in the development of insulin-resistance associated with bedrest. Further,~     since inactivity is likely a principal factor in the development of insulin resistance in the~     elderly, the response to the inactivity imposed by bedrest represents an acceleration of the~     normal development of insulin resistance in elderly individuals. Therefore, the results of~     this study will also be pertinent to the understanding of the mechanisms responsible for the~     natural development of insulin resistance in free-living elderly.~   "
234750|NCT00483197|"~     The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD~     in individuals who are awaiting heart transplants.~   "
234751|NCT00483184|"~     The purpose of this study is to determine the safety and efficacy of natural human interferon~     alpha (IFN alpha) on size, number, incidence and pain of oral ulcers associated with Behçet's~     Disease (BD).~   "
234752|NCT00483171|"~     The purpose of this study is to determine if CP-945,598 is effective in the prevention of~     weight regain in obese subjects.~   "
234753|NCT00483158|"~     The purpose of this study is to study the safety of single doses and multiple doses of~     Finafloxacin hydrochloride in healthy volunteers. The level of Finafloxacin hydrochloride~     will be measured in the subjects blood and urine. One part of the study will assess if~     Finafloxacin hydrochloride eradicates Helicobacter pylori, a stomach bacteria. Another part~     of the study will assess the activity of the drug in urine.~   "
234754|NCT00483145|"~     To evaluate efficacy and adverse effect from long-pulsed dye laser versus long-pulsed dye~     laser-mediated photodynamic therapy for acne vulgaris and rosacea.~   "
234755|NCT00483132|"~     Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy.~      High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma~     (LBL).~   "
234758|NCT00483093|"~     The main objective of the trial is to document the safety of the combination (escalation~     doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80~     mg/sqm). Safety will be established by clinical and laboratory assessment according to~     National Cancer Institute Common Toxicity Criteria (NCI-CTC ).~   "
234759|NCT00483080|"~     The main objective of the trial is to document the progression free survival (PFS) in~     advanced or metastatic colorectal cancer patients treated with NGR-hTNF as single agent.~     Safety will be established by clinical and laboratory assessment according to NCI-CTC~     criteria.~   "
234760|NCT00483067|"~     Primary Objectives:~        1. To determine the response rate, progression-free survival (PFS) and overall survival of~          patients who receive 2-CdA + Ara-C.~        2. To examine if there is any clonality in the cytokine expression of helper T cells or~          cytokine receptor expression of eosinophils.~        3. To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.~   "
234761|NCT00483054|"~     The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and~     tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4~     weeks butt not exceed 16 weeks before enrolment. All patients receive the same backbone~     regimen of stavudine (30 mg/40 mg twice daily)+ lamivudie 150 mg twice daily. They are~     randomized to receive nevirapine 400 mg/day twice daily vs efavirenz 600 mg/day at bed time.~     All patients are followed through 144 weeks after initiation of antiviral therapy. The~     primary objective are to compare the proportion of patient who achieve undetectable plasma~     HIV-1RNA<50 copies/ml at week 48. The previous reports demonstrated that the standard doses~     of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis~     patients who receiving rifampicin even though plasma levels are somewhat reduced by~     rifampicin. However, there have been not been a randomized control trial to compare these two~     regimens. Thus, this trial will provide the efficacy data between these two regimens.~   "
234762|NCT00483041|"~     To evaluate the effect of MEDI-528 in adults with atopic asthma.~   "
234763|NCT00483028|"~     To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing~     (NPT) and brain Proton Magnetic Resonance Spectroscopy.~   "
234764|NCT00483015|"~     We wish to discover if there is a difference in the presentation, response to treatment and~     survival of never- smokers with lung cancer as compared to ever- smokers.~      We also plan to obtain tumor specimens to compare the genetic and proteomic expression~     between smokers and never smokers~   "
234765|NCT00483002|"~     To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg~     medication for 12 weeks in smokers~   "
234766|NCT00482989|"~     To evaluate the safety and tolerability of multiple IV doses of the MEDIMUNNE antibody in~     adult patients with SLE.~   "
234767|NCT00482976|"~     To determine if protein kinase C beta plays a significant role in vascular endothelial~     dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes~     mellitus.~   "
234768|NCT00482963|"~     The purpose of this study is to determine if blood levels of the hormonal emergency~     contraceptive agent, Plan B, are altered by concomitant use with the HIV medication,~     efavirenz.~   "
234769|NCT00482950|"~     This study is to test the efficacy and safety of PHX1149T in combination with metformin, a~     glitazone, or metformin and a glitazone in subjects with Type 2 diabetes for 12 weeks. After~     completing the 12 week double blind part of the study, subjects can enter an open label~     extension study~   "
234770|NCT00482937|"~     The primary objective of this study is to establish the safety of CD-NP in normal human~     volunteers.~   "
234771|NCT00482924|"~     To work against the increasing burden of obesity, the STYJOBS / EDECTA (STYrian Juvenile~     OBesity Study / Early DetECtion of Atherosclerosis) project was started at the Medical~     University of Graz in 2003. STYJOBS / EDECTA is a prospective, observational study to improve~     the understanding of atherosclerosis, cardiovascular risk, immune mediated low grade~     Inflammation, metabolic changes, and general disease propensity in obesity. The investigation~     of the non-biased early phase is strongly focused.~      Based on this information, new and effective strategies for preclinical diagnostics and early~     intervention are of main interest. We seek a better understanding of critical lipid profiles,~     chronic immune-mediated inflammation, disturbed adipokine balance, critical adipose tissue~     topography, addiction like behaviour, genetics/epigenetics, early vascular pathology, and~     fatty liver disease. Interventional branches of study tested a holistic strategy~     comprehending sports, and lifestyle modification for efficiency. The investigative spectrum~     of STYJOBS / EDECTA comprehends also non-obese body weight extremes i.e.~     underweight/anorectic people.~   "
234772|NCT00482911|"~     RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the~     tumor. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving lenalidomide together with sunitinib and low doses of cyclophosphamide once~     a day may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving lenalidomide together with sunitinib~     and cyclophosphamide works in treating patients with stage IV eye melanoma.~   "
234773|NCT00482898|"~     A study to test the effect of MK0359 in lessening the symptoms of asthma as compared to~     placebo.~   "
234774|NCT00482885|"~     High Resolution Manometry (HRM) is a new advance in oesophageal measurement that permits the~     acquisition of pressure data through the entire length of the oesophagus over time via~     closely spaced sensors that continuously record the motor activity of the oesophagus. This~     allows not only contractile pressure to be measured, but also the coordination~     (proximal-distal) of contractions and the development of effective intra-bolus pressure (the~     force that drives bolus movement).~      The study hypothesis is that (1) there will be a progressive increase in peristaltic pressure~     and decrease in velocity as the subjects move from the upright, through the supine to the~     upside down position and (2) the increase in pressure will be most evident in the~     mid-oesophagus at the transition zone between the striated and the smooth muscle~     contractions.~   "
234821|NCT00482248|"~     This study will assess further the safety and tolerability of long-term treatment with~     omalizumab by extending omalizumab treatment by 1 year for those patients with allergic~     asthma who successfully completed study CIGE25011E2.~   "
234775|NCT00482872|"~     RATIONALE: Studying gene mutations in samples of DNA from patients with head and neck cancer~     and a family history of cancer may help doctors learn more about the development of cancer in~     families.~      PURPOSE: This clinical trial is studying germline mutations in patients with head and neck~     cancer and a family history of cancer.~   "
234776|NCT00482859|"~     The purpose of this week long study is to describe sleep and problems with sleep in women~     diagnosed with Fibromyalgia syndrome.~   "
234777|NCT00482846|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Keratinocyte growth factors, such as palifermin, may help prevent symptoms of mucositis, or~     mouth sores, in patients receiving melphalan before a peripheral stem cell transplant for~     multiple myeloma.~      PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when~     given together with palifermin in treating patients undergoing an autologous peripheral stem~     cell transplant for stage II or stage III multiple myeloma.~   "
234778|NCT00482833|"~     Open label, randomised, phase III multicenter trial.~   "
234779|NCT00482820|"~     Studies show that children with high levels of anxiety tend to pay more attention to~     threatening stimulus in the environment. They tend to attend to these stimuli and have~     difficulty to disengage from them. These attention biases enhance and maintain the level of~     anxiety. The aim of this study is to test a method of therapeutically intervention which~     focuses on shifting these attentional biases, with the use of a computer game which was~     designed to train the child to focus his/her attention away from the threatening stimuli and~     to focus on natural or positive stimuli. We will recruit 160 children with ongoing anxiety~     disorders who seek treatment. We will first assess threat-related attention bias and anxiety~     symptoms using structured psychiatric interviews and questionnaires. We will then randomly~     assign these children to one of four conditions: training to avoid threatening stimuli and~     attend to neutral stimuli; control placebo-training for threat-neutral stimuli; training to~     attend to positive stimuli and avoid neutral stimuli; and, control placebo-training for~     positive-neutral stimuli. Upon completion of training we will again assess attention bias and~     anxiety.~      Two sets of predictions will be tested, one set concerns the effects of training on~     attention, and the other concerns the effects of training on anxiety. In terms of training~     effects on attention, we hypothesize that children with anxiety disorders can be trained to~     either avoid threat or attend to positive stimuli. In terms of training effects on anxiety~     symptoms, we hypothesize that the experimental training sessions will produce greater~     reduction in symptoms of anxiety than the placebo-control training sessions.~   "
234780|NCT00482807|"~     RATIONALE: Specialized radiation therapy that delivers a high- dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Androgens can cause the growth~     of prostate cancer cells. Antihormone therapy, such as goserelin and bicalutamide, may lessen~     the amount of androgens made by the body. Giving radiation therapy together with chemotherapy~     and hormone therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when~     given together with intensity-modulated radiation therapy and hormone therapy in treating~     patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.~   "
234781|NCT00482794|"~     Antiphospholipid antibody syndrome (APS) is characterized by the presence of antiphospholipid~     antibodies, which are proteins in the blood that interfere with the body's ability to perform~     normal blood clotting. Clinical problems associated with antiphospholipid antibodies include~     an increased risk for the formation of blood clots in the lungs or deep veins of the legs,~     stroke, heart attack, and recurrent miscarriages. It is possible that some people with APS~     have a genetic predisposition for developing the syndrome. This study will use a genetic~     strategy to identify potential inherited risk factors for the development of APS by~     recruiting people with APS who have family members also affected by the syndrome or by~     another autoimmune disorder, such as lupus or rheumatoid arthritis.~   "
234782|NCT00482781|"~     The purpose of this study is to examine the relationship between receipt of DTaP and the~     occurrence of prolonged episodes of apnea and bradycardia in preterm infants, while employing~     a random control study design and an objective assessment of cardiorespiratory events.~   "
234783|NCT00482768|"~     The purpose of this study is to test an intervention in primary care clinics to improve three~     risk factors for diabetes complications: glucose control, blood pressure and cholesterol.~     Subjects in the study will be clinic staff and clinicians, not patients. The intervention is~     Practice Facilitation. Practice facilitation occurs when a trained facilitator meets with a~     team of staff and clinicians in each practice over a period of several months. Facilitation~     meetings create time for learning and reflection by members of the team and improves their~     communication so that they can adopt and implement a strategy to improve patient care~   "
234784|NCT00482755|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     newly diagnosed stage II or stage IIIA breast cancer that can be removed by surgery.~   "
234785|NCT00482742|"~     The main objectives of the study are:~      To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru~     total occlusions of various dimensions and morphology.~      To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms~     of impact on the treated artery. Following operation of the CiTop device, angiography~     demonstrated successful crossing of the occlusion with no visible evidence of arterial wall~     injury, dissection, or distal embolization.~      To assess ease of operation and the level of integration of the CiTop with standard~     interventional angiography procedure: Balloon angioplasty, placement of stent.~   "
234786|NCT00482729|"~     The purpose of this study is to investigate the efficacy and safety of an investigational~     treatment for type 2 diabetes mellitus.~   "
234822|NCT00482235|"~     A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to~     salmeterol and placebo.~   "
234787|NCT00482716|"~     RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells. Red~     blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known~     whether epoetin alfa or epoetin beta are more effective when given with or without iron~     infusion in treating anemia in patients with cancer.~      PURPOSE: This randomized phase III trial is studying epoetin alfa or epoetin beta to compare~     how well they work with or without iron infusion in treating anemia in patients with cancer.~   "
234788|NCT00482703|"~     The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered~     for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid~     leukemia (CML) once daily (QD) or twice daily. (BID)~   "
234789|NCT00482690|"~     Analysis of aldeyde biomarkers of exposure and host response The purpose of this prospective,~     open-label, clinical trial is to establish the feasibility and validity of exhaled breath~     condensate (EBC) biomarkers for use in studies designed to evaluate harm reduction strategies~     of smoking. This will be accomplished by measuring selected markers in EBC believed related~     to the pathogenesis of lung disease before and after a smoking cessation intervention.~   "
234790|NCT00482677|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving radiation therapy~     together with temozolomide may kill more tumor cells. It is not yet known whether radiation~     therapy and temozolomide are more effective than radiation therapy alone in treating~     glioblastoma multiforme.~      PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to~     see how well they work compared with radiation therapy alone in treating patients with newly~     diagnosed glioblastoma multiforme.~   "
234791|NCT00482664|"~     CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been~     shown in animal models to restore sexual function.~   "
234792|NCT00482651|"~     Atherosclerosis is a chronic and multifocal immunoinflammatory, fibroproliferative disease of~     medium-sized and large arteries driven by lipid. Atherosclerosis is rarely fatal unless~     thrombosis supervene, causing an acute coronary syndrome. Therefore, for event-free survival,~     the vital question is not why atherosclerosis develops but rather why atherosclerosis, after~     years after indolent growth, suddenly becomes complicated with luminal thrombosis.~      The great majority of coronary plaques will remain quiescent, at least from a clinical point~     of view.~      Acute coronary syndrome is primarily precipitated by a ruptured plaque. The precipitating~     factor or condition may be found outside rather than inside the plaque.~      The challenge is to find the plaque(s) destined for the next thrombus-mediated heart~     attack(s), treat, and thus avoid the heart attack(s). Identification of vulnerable plaques~     has become a key issue. The natural history of individual plaques (risk of thrombosis) is~     unknown and needs to be established.~      Multidetector computed tomography (MDCT) can provide angiography and imaging of the vessel~     wall (detection, quantification and characterization of plaques).~      The intention of this project is to evaluate the accuracy of coronary MDCT in identifying and~     differentiating the morphology of coronary atherosclerotic plaques.~   "
234793|NCT00482638|"~     To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.~   "
234794|NCT00482625|"~     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial~     is studying how well erlotinib hydrochloride works in treating patients with pancreatic~     cancer that can be removed by surgery~   "
234795|NCT00482612|"~     The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and~     effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean~     Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.~   "
234796|NCT00482599|"~     The purpose of this study is to compare the efficacy and pharmacokinetics of Org 25969 in~     subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in~     subjects with impaired renal function.~   "
234797|NCT00482586|"~     RATIONALE: Gathering information about quality of life over time from patients with liver~     cancer treated with image-guided therapy may help the study of cancer in the future.~      PURPOSE: This clinical trial is gathering information about quality of life over time from~     patients with liver cancer treated with image-guided therapy.~   "
234798|NCT00482573|"~     The hemodynamic parameters of 31 pregnant women with rheumatic valve disease, undergoing~     restorative dentistry under local anesthesia with 2% solution of lidocaine, divided in two~     groups, with (Group LE) and without 1:100,000 epinephrine solution (Group LNE), were studied~     by 24-hour ambulatory electrocardiographic monitoring, intermittent blood pressure monitoring~     and continuous cardiotocography, during three standard time periods. A significant decrease~     in the values of maternal heart rate was seen during the procedure, in comparison with the~     other two time periods in the two groups, as well as, the occurrence of cardiac arrhythmia in~     9 (29.1%) patients, being 7 (41.8%) of them in the group receiving epinephrine anesthesia. We~     conclude the use of 2% lidocaine in association with epinephrine proved safe during dental~     procedure in pregnant women with rheumatic valve disease.~   "
234799|NCT00482560|"~     The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose~     solution vs breastfeeding on neonatal screening heel lance~   "
234800|NCT00482547|"~     Urinary catheters are often needed in hospital patients, but their use can increase the~     chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This~     study will try to determine if patients who get a new silver coated catheter will have slower~     to time to development of a CAUTI compared to patients who get an uncoated catheter.~   "
234801|NCT00482521|"~     RATIONALE: CC-4047 may stop the growth of tumor cells by blocking blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of CC-4047 in treating~     patients with advanced solid tumors that did not respond to treatment.~   "
234802|NCT00482508|"~     This study will assess the safety and tolerability of long-term treatment with omalizumab~     plus current asthma therapy in patients who participated in and successfully completed the~     treatment period of study CIGE025IA04E1. Patients who participated in CIGE025IA04E1 were~     perceived by both the patient and the investigator to have benefited from receiving treatment~     with omalizumab plus current asthma therapy according to best medical practice~   "
234803|NCT00482495|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the~     growth of multiple myeloma by blocking blood flow to the cancer.~      PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with~     relapsed or refractory multiple myeloma.~   "
234804|NCT00482482|"~     Major depression, chronic depression and bipolar depression are complex and difficult~     disorders to treat. They are often associated with residual symptoms with significant~     functional impairment. Yoga has been shown to be beneficial in treating depressive symptoms~     but without the added risks associated with medication use and has the advantage of high~     consumer appeal (with likelihood of good compliance). However, it has only been tested in~     unipolar depression, thus far. Yoga if shown to be effective (as an adjunctive to~     pharmacotherapy) in improving residual symptoms and decreasing risk of relapse, would be of~     significant long-term benefit to patients not only with major and chronic depression, but~     also for those with bipolar disorder.~      The aim of the study is to determine the safety and effectiveness of Yoga as an augmentation~     treatment to pharmacotherapy and in comparison to psychoeducation, in improving residual~     symptoms of depression over 16 weeks and in prevention of relapse/recurrence of mood episodes~     over 1 year, in subjects with unipolar and bipolar disorders.~   "
234805|NCT00482469|"~     It is our goal to study the mechanism of ischemia-reperfusion injury. Our DIEP-operation is~     actually a clinical model of ischemia-reperfusion. Ischemia-reperfusion injury has never been~     directly studied in a human, clinical model of autologous transplant.~   "
234806|NCT00482456|"~     Our study looks at the interaction of a common mutation in the MTHFR gene and the risk of~     developing higher homocysteine levels after nitrous oxide (N2O) anesthesia.~      Specifically, we want to test the hypothesis that healthy patients carrying the MTHFR 677C>T~     haplotype develop abnormal homocysteine levels after nitrous oxide anesthesia.~   "
234807|NCT00482443|"~     For people with Type 1 Diabetes, blood glucose control is achieved by matching insulin doses~     directly to the amount of carbohydrate consumed. We are looking at new ways to help our~     patients with type 1 diabetes manage their diabetes control more effectively. We are testing~     if Diabetes Interactive Diary (DID), a novel programme designed to be used on a mobile~     phone, can represent an important tool in carbohydrate counting while avoiding the use of~     complex calculations and in depth knowledge about the carbohydrate content of their food.~   "
234808|NCT00482430|"~     The purpose of this study is to determine the safety and effectiveness of an investigational~     drug for the treatment of cognitive impairment in patients with schizophrenia.~   "
234809|NCT00482417|"~     Efficacy and Safety Study of MK0359 in Patients with Arthritis~   "
234810|NCT00482404|"~     This trial tests the hypothesis that increasing nonverbal affection in romantic relationships~     will improve blood lipid parameters (total cholesterol, high and low density lipoproteins,~     triglycerides), blood glucose, and immune parameters (C-reactive protein and antibodies to~     latent Epstein-Barr virus). 52 healthy cohabiting romantic couples took part. In half of the~     couples, one partner increased the frequency of romantic kissing with the other partner~     during the six-week trial. The other couples received no such instruction. Blood tests~     performed before and after the trial were used to assess the health outcomes.~   "
234811|NCT00482391|"~     The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.~   "
234812|NCT00482378|"~     RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry~     radiation directly to cancer cells and not harm normal cells. Zoledronic acid and pamidronate~     may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam~     pentasodium together with zoledronic acid or pamidronate may be an effective treatment for~     multiple myeloma.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153~     lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how~     well it works in treating patients with relapsed or refractory multiple myeloma and bone~     pain.~   "
234813|NCT00482365|"~     RATIONALE: Gathering health information about patients with liver cancer over time may help~     doctors learn more about the disease and may help the study of cancer in the future.~      PURPOSE: This clinical trial is developing a national registry and blood bank of patients~     with liver cancer.~   "
234814|NCT00482352|"~     This clinical trial is studying risk-group classification of patients with newly diagnosed~     acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors~     assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical~     trials.~   "
234815|NCT00482339|"~     Using methods of molecular biology bacteria can be detected in blood. In comparison to~     conventional blood cultures bacterial DNA is isolated using a new sample preparation system~     in platelet apheresis concentrates and in the predonation whole blood of donors.~   "
234816|NCT00482313|"~     The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in~     treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.~   "
234817|NCT00482300|"~     The purpose of this trial is to determine whether the addition of systematic pelvic~     lymphadenectomy to hysterectomy with bilateral adnexectomy improves disease-free survival~     (DFS) and overall survival (OS) in patients with preoperatively supposed Stage I-II~     endometrial cancer~   "
234818|NCT00482287|"~     The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic~     effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population~     of cardiac surgery patients.~   "
234819|NCT00482274|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with~     relapsed prostate cancer.~   "
234820|NCT00482261|"~     The purpose of this study is to see whether combination of low dose lenalidomide(10mg)+~     dexamethasone is equally effective in treating relapsed/refractory myeloma in the group of~     elderly patients and other patients at risk of myelosuppression, whilst producing less side~     effects, especially myelosuppression compared to the higher dose of lenalidomide of 25mg used~     in the MM-009 and MM-010 trials.~   "
234823|NCT00482222|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and~     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     combination chemotherapy together with monoclonal antibodies before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these~     treatments after surgery may kill any tumor cells that remain after surgery. It is not yet~     known whether combination chemotherapy is more effective with or without cetuximab in~     treating liver metastases caused by colorectal cancer.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how~     well it works when given with or without cetuximab before and after surgery in treating~     patients with resectable liver metastases caused by colorectal cancer.~   "
234824|NCT00482209|"~     This double-blind, randomized study will compare the efficacy and acceptability of~     mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e.,~     in the cheeks) for termination of pregnancy in women up to 63 days LMP.~   "
234825|NCT00482196|"~     To study different doses of MK0493 for safety, efficacy and tolerability in obese patients.~   "
234826|NCT00482183|"~     Drug-eluting stents have been shown to decrease restenosis, but were associated with an~     increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones~     effectively reduced restenosis and the risk of repeat target vessel revascularization. We~     conducted a study to compare the performance of a drug-eluting stent with that of a~     bare-metal stent with pioglitazone in patients with type 2 diabetic mellitus.~   "
234827|NCT00482170|"~     Primary objective of this study is to compare patient satisfaction with the prefilled syringe~     (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12~     weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary~     evaluation focus on the identification of patient and device attributes associated with~     patient satisfaction.~   "
234828|NCT00482157|"~     After the diagnosis of prostate cancer, many men alter their lifestyle or diet or use various~     supplements in an attempt to retard the growth of their cancer. While there is limited data~     on the use of diet and supplements to alter the risk of prostate cancer, even less is known~     regarding the ability of diet or supplements to alter progression. For men who have elected~     active surveillance, the investigators propose to investigate the ability of vitamin D to~     retard the growth of prostate cancer.~   "
234829|NCT00482144|"~     The purpose of this study is to compare the effects of the pulsed-dye laser (PDL) at two~     different wavelengths, 585nm and 595nm, in the treatment of post-surgical scars starting on~     suture-removal day.~   "
234830|NCT00482118|"~     Background:~        -  Women in Xuan Wei County, China, are almost all non-smokers, yet they have the highest~          lung cancer rate in that country.~        -  Non-smoking women in Xuan Wei who use smoky coal for cooking and heating homes can~          inhale 10 times higher levels of polycyclic aromatic hydrocarbons (PAH, compounds formed~          in many burning organic substances, including smoky coal) than someone who smokes 20~          cigarettes a day.~      Objectives:~        -  Determine the health effects of smoky coal in Xuan Wei and Fu Yuan counties in China's~          Yun Nan Province~        -  Determine how different levels of exposure to smoky coal and other types of fuel affect~          the amount of smoky coal emissions that are absorbed into the body~        -  Determine genetic risk factors for lung cancer in the study population and determine how~          they interact with smoky coal and PAH exposure.~      Eligibility:~        -  Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who have lung~          cancer and do or do not use smoky coal~        -  Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who do not have~          lung cancer and do or do not use smoky coal~      Design:~      -Exposure assessment study for users of smoky coal - 150 households~      Use of air badges, monitors, and dermal badges to determine subjects' exposure to smoky coal~      Collection of blood, urine, cheek cell and sputum samples to measure the amount of smoky coal~     emissions absorbed into the body and evaluate the types of biologic changes they cause~      Interview subjects about their health and family history, occupational exposures, lifestyle~     factors (e.g., tobacco smoking and diet), and inherited differences in genes~      -Case-control study - 1,000 women~      Collection of blood, urine, cheek cell and sputum samples to measure how amount of smoky coal~     emissions absorbed into the body and evaluate types of biologic changes they cause~      Interview subjects about their health and family history, occupational exposures, lifestyle~     factors (e.g., tobacco smoking and diet), and inherited differences in genes~      Gene analysis to determine if a genetic variation is associated with an increased or~     decreased risk of health effects from smoky coal exposure~   "
234831|NCT00482105|"~     This study is divided into distinct sample collection and analysis phases. In the sample~     collection phase investigators will tape strip lesions that are designated for biopsy because~     they are suspected for melanoma. No biopsies will be taken solely in support of this study;~     rather patients that present lesions that are to be biopsied—in the context of the standard~     of care—will be enrolled in the study and will have that lesion(s) tape stripped before the~     biopsy procedure.~      In the second phase of the study, tape strip samples will be extracted and RNA purified and~     expression profiled by DNA microarray. The gene expression data will be correlated with~     histopathology with the expectation that an expression classifier that distinguishes suspect~     lesions from melanoma can be defined. That classifier will be validated in future studies.~   "
234832|NCT00482092|"~     Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant~     to, or have previously failed therapy with, at least one steroid and at least one~     immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The~     protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to~     induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks,~     for approximately an hour each time.~   "
234833|NCT00482079|"~     A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control~     of their blood sugar.~   "
234834|NCT00482066|"~     The purpose of this study is to investigate whether abatacept can prevent relapse in patients~     with ANCA associated vasculitis(AAV). This is a randomised double blinded placebo controlled~     trial.~   "
234835|NCT00482053|"~     The purpose of this study is to determine if double autologous then allogeneic hematopoietic~     cell transplant may offer an improved treatment option for patients with relapsed diffuse~     large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional~     transplantation regimen.~   "
234836|NCT00482040|"~     The purpose of this study is to evaluate four different nasal continuous pressure systems,~     which are usually applied on our neonatal intensive care unit, with regard of their effect on~     bradycardia and desaturations in preterm infants.~   "
234837|NCT00482027|"~     The purpose of this study is to determine safety and immunogenicity (ability to induce an~     immune response) of a novel HIV vaccine based on adeno-associated virus (AAV)~   "
234838|NCT00482014|"~     The primary purpose of this study is to determine the 2-year survival rate of both of the~     chemotherapy regimens in patients with inoperable non-small-cell lung cancer.~   "
234839|NCT00482001|"~     The goal of the study is to assess the role of cholinesterase inhibitors in affecting the~     driving ability of cognitively intact seniors using driving simulators. We hypothesize that~     the use of a cholinesterase inhibitor for two weeks will be associated with improvement in~     safe driving behavior on a simulated driving task.~   "
234840|NCT00481988|"~     The purpose of this study is to see if transcranial direct current stimulation may improve~     the symptoms of depression.~   "
234841|NCT00481975|"~     The primary objective is to assess the effect of rimonabant compared to placebo on weight~     loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients~     with binge eating disorder.~      The secondary objectives are:~        -  to assess the effect of rimonabant on the number of binge episodes per week, to assess~          the effect of rimonabant on eating behavior using the Binge Eating Scale (BES) and Three~          Factor Eating Questionnaire (TFEQ),~        -  to evaluate the safety and tolerability of rimonabant over a period of 6 months.~   "
234842|NCT00481962|"~     The main goals of the study are: Assessment of Tygacil's cost-effectiveness; Process cost~     analysis from a hospital perspective (including length of stay, treatment costs, side effect~     management costs, costs of monitoring, costs of diagnostic procedures, cost of care (TISS 10~     score etc.); Efficacy of Tygacil under usual care conditions (cure rate).~   "
234843|NCT00481949|"~     Monitoring oesophageal pH provides a definitive diagnosis of patients with gastro-oesophageal~     reflux disease (GORD), especially those in whom the association between reflux and symptoms~     is uncertain and those under consideration for anti-reflux surgery. Standard ambulatory~     investigation is normally performed by naso-oesophageal catheter however this is associated~     with considerable discomfort and in turn altered behaviour which reduces reflux provoking~     activities. Furthermore results of catheter based ambulatory pH studies are compromised by~     the high variability of acid exposure in patients with suspected GORD.~      Prolonging pH measurements by the catheter-free Bravo™ system from 24 to 48 and 96hrs~     significantly improves the consistency (reliability) and reproducibility of diagnoses based~     on oesophageal acid exposure, as well as the ability to associate acid reflux to symptom~     episodes. This improves diagnosis especially in those with intermittent symptoms.~      However pH monitoring does not provide a direct assessment of the underlying pathophysiology.~     Incompetence of the oesophago-gastric junction (OGJ) related to disruption of its structure~     and function is considered to be the most important cause of GORD. A more relevant assessment~     of the reflux barrier may be its distensibility (i.e. the ease with which the OGJ is opened~     to allow retrograde passage of gastric contents); however this is not assessed by current~     clinical investigations.~      Endo-FLIP (Crospon Medical Devices) is a new tool which assesses OGJ structure and function,~     and appears to provide relevant information regarding its distensibility and competence.~      This study applies to using Endo-Flip to record OGJ distensibility and Bravo to record acid~     exposure and symptom association in patients with reflux symptoms. The variability of pH~     measurements and symptoms and diagnostic accuracy will be assessed over 96hrs. Endo-FLIP~     results will then be compared against Bravo. The outcome of post investigation therapy will~     then be compared with Endo-Flip and Bravo results to assess if baseline testing can predict~     the outcome of acid suppression therapy.~      Study Hypothesis~        1. There is a positive, continuous association between OGJ distensibility measured by~          Endo-FLIP on % acid exposure assessed by prolonged Bravo pH monitoring~        2. The results of Endo-FLIP and prolonged Bravo predict treatment outcome of a trial of~          proton pump inhibitor therapy~   "
234844|NCT00481936|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of VB6-845 and to~     evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV~     infusion to patients with advanced solid tumour of epithelial origin.~   "
234845|NCT00481923|"~     The primary objective of this study is to assess the effect of rimonabant on the energy~     intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and~     post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice,~     cravings and feelings of control.~      The secondary objectives are to determine the effect of rimonabant on body weight with or~     without hypocaloric diet and its clinical and laboratory safety.~   "
234846|NCT00481897|"~     The Worksite Nutrition Study is 22-week translational study aimed at determining how well a~     worksite-based nutrition program, as compared to a control group, is able to 1) produce~     clinically significant weight-loss, 2) improve cardiovascular factors, 3) decrease work~     absenteeism, 4) improve overall quality of life, 5) improve diabetes control in participants~     with diabetes, and 6) promote dietary adherence and acceptability. The nutrition program for~     the intervention group consists of once-weekly group meetings where participants will receive~     group support and nutrition education on a low-fat, vegan diet.~   "
234847|NCT00481884|"~     Primary Objective:~      To determine if RadiaPlexRx Hydrogel can reduce the development of grade 2 or higher~     radiation dermatitis in breast cancer from adjuvant radiation when compared to a~     petroleum-based gel (Aquaphor) commonly used as best supportive care.~   "
234848|NCT00481871|"~     This study is for patients with lymphoproliferative malignancies that have progressed after~     receiving a previous treatment (relapsed) or are no longer responding to treatment~     (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma~     (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's~     macroglobulinemia.~      This study is being done to find doses of the combination of pralatrexate and gemcitabine~     with vitamin B12 and folic acid that can be safely given to patients with these types of~     lymphoma and explore the effectiveness of the treatment.~   "
234849|NCT00481858|"~     This project will attempt to validate the utilization of a stable isotope kinetic biomarker~     (KineMarkerTM) as a predictive test for disease progression in early stage chronic~     lymphocytic leukemia (CLL).~   "
234850|NCT00481845|"~     In this study we plan to study the combination of ZD6474, a dual inhibitor of EGFR and~     VEGFR-2 with anastrozole in the neoadjuvant setting for patients with Stage I-III breast~     cancer. The aim is to overcome mechanisms of resistance and simultaneously block multiple~     critical signaling pathways known to stimulate breast cancer.~   "
234851|NCT00481832|"~     The purpose of this trial is to develop an alternative treatment for patients with poor risk~     non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem~     cell transplant using the patient's own cells. This is followed with non-myeloablative~     transplant using stem cells from a related or unrelated donor to try and generate an~     anti-lymphoma response from the new immune system.~   "
234852|NCT00481819|"~     The patients about to undergo kidney transplantation will be randomized to one of the~     following two group:~      Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment~     period is 3 months( 12 weeks)~   "
234853|NCT00481806|"~     Heart bypass surgery, also known as coronary artery bypass graft (CABG) surgery, creates a~     detour around the blocked part of a heart artery to restore blood supply to the heart muscle.~     The saphenous vein, located along the inside of the leg, is commonly used to create the~     bypass in a CABG surgery. An abnormal increase in the blood clotting protein thrombin may~     cause the saphenous vein graft to close up and eventually fail. This study will evaluate the~     relationship between thrombin levels and saphenous vein graft failures in people undergoing a~     CABG procedure.~   "
234854|NCT00481793|"~     This is a collaborative study by the National Cancer Institute, Columbia University, and the~     Southern Urals Biophysics Institute in Russia. It will examine the relationship of~     differences in certain genes to the development of chromosomal abnormalities in workers at~     the Mayak nuclear production plant in Ozyorsk, Russia. This population was exposed to higher~     radiation doses from external and internal sources than those received by their counterparts~     in other countries or considered permissible today. If a risk relationship is found between~     genetic differences and chromosome abnormalities, the information might be useful in studies~     designed to examine how high radiation exposures cause cancer.~      Radiation-exposed Mayak workers employed from 1948 to 1972 in the three Ozyorsk plants~     directly related to nuclear weapons production may be eligible for this study. They must have~     remained local residents in the area and estimates of their external and internal radiation~     exposures must be available.~      Participants provide a blood sample for genetic studies and answer a questionnaire that~     includes demographic information and information about their family health history, history~     of benign tumors, if any, and history of smoking and alcohol consumption. Additional~     information is collected from patients' medical records.~   "
234855|NCT00481780|"~     Percutaneous transluminal angioplasty (PTA) is a minimally invasive technique for treatment~     of superficial femoropopliteal artery (SFA) obstructions or occlusions in patients with~     intermittent claudication as well as critical limb ischemia. Initial technical success rates~     of above 95% can be achieved and acceptably low rates of complications are consistently~     reported in the literature. There is a direct relation between treated vessel length and~     patency rates. One year patency of lesions longer than 10cm has only been 22% at one-year~     follow up. This major drawback limits a widespread applicability of PTA, and the indication~     of PTA particularly in patients with intermittent claudication is discussed~     controversially.With the introduction of endovascular stents, the problems of elastic recoil~     and residual stenoses due to arterial dissection could be resolved and initial reports of~     stenting for the treatment of occlusive atherosclerotic disease of the SFA showed promising~     results with primary and secondary patency rates of 87% to 90% after 18 months. However,~     subsequent studies demonstrated that exaggerated neo-intimal hyperplasia in the stented~     segment frequently leads to instent restenosis. This condition will be of greater importance~     with increasing number of stent implantation procedures during the last years. The concept of~     cutting balloon seems appealing for this indication, as the balloon-mounted microtomes~     guarantee smooth lumen gain within the stent, without the risk of vessel wall perforation.~     Initial reports of the use of the cutting balloon for the treatment of occlusive~     atherosclerotic disease of the SFA show promising results, indicating that the problems of~     elastic recoil and residual stenoses due to arterial dissection might be resolved. The~     cutting balloon has four tiny microtomes (< 0.1mm height) on the outside, which cut the~     fibrous plaque during expansion of the balloon. Consequently the problem of elastic recoil is~     ideally addressed, additionally less trauma is exercised on the vessel wall during dilatation~     of the balloon. This might be achieved by a reduction of vessel wall trauma, vessel wall~     inflammation and consequently reduced neointimal formation. Although the indications for~     CB-PTA in the SFA includes significant residual stenosis or in-stent restenosis, there are~     currently no published randomized controlled trials (RCT) comparing PTA vs. cutting balloon~     angioplasty (CB-PTA) for any specific condition. This lack of data led us to initiate a RCT~     comparing primary PTA vs. CB-PTA for treatment of in-stent restenoses in patients with~     intermittent claudication or critical limb ischemia with TASC category A-B in the~     femoropopliteal artery .~   "
234856|NCT00481767|"~     Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000~     new cases are reported each year worldwide, from which 83% occur in developing countries. The~     incidence of cervical cancer varies depending on the region of the world. Africa has some of~     the highest age-standardized incidence and mortality rates in the world (Eastern Africa 42.7~     and 34.6 per 100 000; Southern Africa 38.2 and 22.6 per 100 000; Western Africa 29.3 and 23.8~     per 100 000; Middle Africa 28.0 and 23.0 per 100 000).~      As in the majority of developing countries, organization of cervical cancer screening~     programs in Africa is difficult to manage, especially in rural areas. HPV prophylactic~     vaccination could therefore clearly and efficiently decrease the incidence of cervical~     cancer. The current study is designed to assess the immunogenicity and safety of GSK~     Biologicals' HPV-16/18 L1 AS04 vaccine in female subjects enrolled from multiple countries in~     Africa.~      Ideally, HPV vaccination should be performed before onset of sexual activity, since studies~     have shown that acquisition of high-risk HPV occurs soon after sexual debut. This study will~     therefore be performed in subjects aged 10 to 25 years of age.~   "
234857|NCT00481754|"~     Background:~        -  Endometrial cancer (cancer of the lining of the uterus) is the most common gynecologic~          cancer in the United States.~        -  Currently, there are no markers (components of blood and tissue that determine who might~          be at risk for developing cancer) for endometrial cancer.~      Objectives:~      -To see if women who are undergoing hysterectomy are willing to provide blood and tissue~     samples to help doctors identify markers that would indicate increased risk for developing~     endometrial cancer.~      Eligibility:~      -Women between 35 and 54 years of age who will undergo hysterectomy for a non-cancerous~     condition, such as uterine fibroids, uterine prolapse, abnormal uterine bleeding, and others~     at Magee-Women's Hospital in Pittsburgh, Penn.~      Design:~        -  Patients' medical records are reviewed and patients complete a questionnaire including~          information on race and ethnic background, education, marital status, family history,~          height, weight, pregnancy history, smoking history, medication history, history about~          menstrual periods and menopausal symptoms.~        -  Patients provide blood and urine samples before surgery.~        -  A sample of fat tissue is removed during surgery in patients undergoing abdominal~          surgery.~        -  Tissue samples from the removed uterus (and ovaries if the ovaries are also removed) are~          collected and analyzed for markers for endometrial cancer.~   "
234858|NCT00481741|"~     We seek to determine if the use of the SafeSeal(TM) topical hemostasis patch is associated~     with reductions in time to hemostasis and time to ambulation compared to standard manual~     compression after arterial sheath removal following percutaneous coronary and peripheral~     intervention. We further seek to assess the safety of the SafeSeal patch compared to manual~     compression.~   "
234859|NCT00481728|"~     Measuring sympathetic skin response or heart rate variability can provide an objective~     biomarker of bladder sensation and its modulation by drug with potential to treat overactive~     bladder.~   "
234860|NCT00481715|"~     Obesity has reached epidemic proportions in the United States with nearly 64% of American~     adults considered overweight or obese. Weight loss programs that take place at work have~     proven to be effective at promoting healthy lifestyles. The purpose of this study is to~     compare the effectiveness of a Web-based weight loss program versus a cash incentive weight~     loss program among employees at North Carolina universities and colleges.~   "
234861|NCT00481702|"~     A multicenter study to evaluate the effectiveness of ertapenem compared to~     ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in~     adult patients.~   "
235140|NCT00477958|"~     RATIONALE: A study that assesses the ability of older patients to think, learn, remember,~     make judgments, and carry out daily activities may help doctors plan treatment for older~     patients with cancer.~      PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.~   "
234862|NCT00481689|"~     Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can~     help people with a complicated urinary tract infection caused by a kind of bacteria called~     Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is~     safe and works to treat complicated urinary tract infections caused by Pseudomonas~     aeruginosa. The study doctor will also gather information about using Cipro XR to treat~     complicated urinary tract infections caused by other bacteria. About 500 people with~     complicated urinary tract infections who are 18 years old and older will join this study.~     Cipro XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of~     complicated urinary tract infections and acute uncomplicated pyelonephritis (inflammation of~     the kidney). The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has~     been shown to be safe and effective. This study is being done to gather more information on~     using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas~     aeruginosa, as well as by other bacteria.~   "
234863|NCT00481676|"~     This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to~     severe chronic urticaria who exhibit IgE against thyroperoxidase.~   "
234864|NCT00481663|"~     A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There~     have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week~     106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In~     participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of~     treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering~     hemoglobin A1C (HbA1c).~   "
234865|NCT00481650|"~     A prospective, observational study (Anwendungsbeobachtung [AWB]) of the prescribing and~     administration practices of German gynecologists with Leios® Dragées.~   "
234866|NCT00481637|"~     The purpose of this study is to study whether immune cells capable of killing tumors that~     express proteins associated with paraneoplastic neurologic syndrome (PNS) can be found in~     small cell lung cancer and ovarian cancer patients. The presence of these cells may play a~     role in tumor immunity in these patients. The protocol involves neurological examinations and~     collection of blood.~   "
234867|NCT00481624|"~     The purpose of this study is to find a better, more convenient way to improve anemia results~     by increasing the amount of medication given at 3 week intervals. Researchers want to know if~     giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give~     better results in treating anemia without the need for more office visits.~   "
234868|NCT00481611|"~     Background:~        -  Trichloroethylene (TCE) is a solvent used in many medical and industrial processes.~        -  TCE is a carcinogen (causes cancer) in rats, but its carcinogenicity in humans is~          unclear. There is some evidence of increased liver and kidney cancers and of an~          association with non-Hodgkin lymphoma in studies of workers exposed to TCE.~        -  The carcinogenicity and regulation of TCE is a matter of continuing debate.~      Objectives:~        -  To determine if TCE exposure is associated with higher levels of genetic aberrations in~          certain white blood cells called lymphocytes.~        -  To determine if TCE exposure affects lymphocyte subsets and levels of certain hormones~          called cytokines.~      Eligibility: Workers exposed to two different levels of exposure to TCE and unexposed workers~     in Guangdong Province, China.~      Design:~        -  45 workers exposed to more than 25 parts per million (ppm) TCE, 30 workers exposed to~          from 10 to less than 25 ppm TCE and 45 unexposed workers will be enrolled.~        -  Subjects wear small instruments at work that measure chemicals in the air for 1 or 2~          days during the 2-week study period. Exposed workers also wear several small skin~          patches on one of the two days.~        -  Subjects provide blood and urine samples.~        -  Subjects answer a questionnaire about work, smoking and drinking, use of medicines,~          medical history, general health, hobbies, and exposure to radiation and exposure to~          various substances at home.~   "
234869|NCT00481598|"~     Patients with Type 1 diabetes (T1DM) suffer from impaired postprandial hepatic glycogen~     storage and breakdown, if they are under poor glycaemic control. Poor glycogen storage in the~     liver puts these patients at risk of fasting hypoglycaemia. Amelioration of glycaemic control~     could improve these abnormalities and thereby reduce the risk of hypoglycaemia in these~     patients. The gold standard technique for the assessment of hepatic glycogen metabolism in~     humans, 13 C magnetic resonance spectroscopy (13C-MRS), is expensive and limited to a few~     centers worldwide. Furthermore, treated type 1 diabetic patients exhibit skeletal muscle~     insulin resistance when treated insufficiently. This condition can also be reversed by~     improvement of glycaemic control. Recent studies link skeletal muscle insulin resistance to~     impaired mitochondrial function. Up to date, the impact of glycaemic control on skeletal~     muscle mitochondrial function has not yet been assessed.~      Aim 1 of our project is to establish a new assessment method for glycogen metabolism. This~     new method is based on oral administration of 2H2O and acetaminophen.~      Our second aim is to examine the impact of improvements of glycaemic control on skeletal~     muscle mitochondrial function in type 1 diabetic patients.~      Our third aim is to assess the ATP-synthesis in T1DM.~      We will conduct a prospective study on 14 patients with type 1 diabetes and 14 healthy~     controls.~      On the respective study day, participants will be served three standardized meals, blood~     sugar will be controlled hourly and blood samples will be drawn at timed intervals to~     determine glucoregulatory hormones, metabolites and enrichments of [6,6-2H2]glucose.~      During the night, four 13C-MRS-measurements will be performed in combination with~     [6,6-2H2]glucose infusion to assess glucose production, glycogen breakdown and~     gluconeogenesis.~      In addition, patients will drink 3g/kg bodyweight 2H2O and acetaminophen will be~     administered. Thus the new 2H2O-acetaminophen method will be applied simultaneously with the~     gold standard method.~      The following morning, mitochondrial function will be assessed in skeletal muscle from~     unidirectional flux through ATP synthase by 31P MRS.~      TIDM patients will be studied twice. First, under conditions of insufficient glycaemic~     control and the second time after three months of intensified insulin treatment using CSII~     pumps aiming at optimized metabolic control. Healthy controls will be studied only once.~      To assess muscular mitochondrial function in T1DM we will measure ATP synthesis in a calf~     muscle with magnetic resonance spectroscopy. First, we will conduct a basal measurement.~     Thereafter, we will start a hyperinsulinaemic euglycemic calmp to stimulate the ATP synthesis~     and measure again.~      This study will provide information on rates of post absorptive glycogen breakdown,~     gluconeogenesis, and postprandial glycogen storage in the liver and on the skeletal muscle~     mitochondrial function under conditions of optimized glycaemic control for 3 months.~      Finally, this study will demonstrate whether or not poorly controlled type 1 diabetic~     patients exhibit abnormalities in muscle mitochondrial function and to what extent those~     alterations can be reversed by optimized glycaemic control. We expect to validate the~     2H2O-acetaminophen method, which will provide justification for a broad scale in clinical~     studies.~   "
234870|NCT00481585|"~     The objective of the present study is to determine whether or not primary human mammary~     epithelial cells are competent for use in molecular studies of transepithelial~     electrophysiology focusing on the function of the tight junction protein claudin 3.~      Human breast Tissue will be removed from mastectomy specimens and used as a source to~     generate epithelial cells for study.~   "
234871|NCT00481572|"~     The purpose of this study is to determine whether: A)the continuous infusion ultra-low dose~     of terlipressin (1.3 micrograms/kg/h) is able to stabilize hemodynamic in patients with~     septic shock, reducing the risk of adverse effects related to the bolus dose.B)the continuous~     infusion ultra-low dose of terlipressin may be use in lieu of vasopressin.~   "
234872|NCT00481559|"~     This protocol is for the treatment of toxic plasma methotrexate concentrations (>1 micromole~     per liter) in patients with delayed methotrexate clearance due to impaired renal function~   "
234873|NCT00481546|"~     A recombinant adeno-associated virus serotype 2 (rAAV2) vector has been altered to carry the~     human RPE65 (hRPE65) gene. This vector has been shown to restore vision in animal models that~     resemble human RPE65-associated Leber congenital amaurosis (LCA), an incurable retinal~     degeneration that causes severe vision loss. The proposed study is an open label, Phase I~     clinical trial of subretinal rAAV2-CBSB-hRPE65 administration to individuals with~     RPE65-associated retinal disease. Five cohorts will be included in this trial. Cohorts 1, 2~     and 4 will consist of individuals 18 years of age and older. Cohorts 3 and 5 will consist of~     individuals between the ages of 8 and 17, inclusive. Enrollment in Cohorts 3 and 5 will begin~     only after confirming the safety of rAAV2-CBSB-hRPE65 administration in the older groups of~     participants. This trial will lead to a greater understanding of the safety and thereby~     potential value of gene transfer in RPE65-associated retinal disease and will have~     implications for other forms of retinal degenerative disease amenable to this type of~     intervention.~      The goal of this clinical trial is to determine the safety of uniocular subretinal~     administration of rAAV2-CBSB-hRPE65 in individuals with RPE65-associated retinal disease.~     Ocular and systemic toxicity will be assessed prior to and following vector administration to~     determine if there are adverse changes that may be associated with vector administration.~   "
234874|NCT00481533|"~     Despite of marked improvements in clinical management, early postpartum~     hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in~     developing countries and in hospitals equipped with all that modern medicine has to offer.~     This complication is amongst the most challenging that a clinician will face in the obstetric~     patient. Prevention, early recognition and prompt appropriate intervention are the keys to~     minimizing the impact of PPH on women’s health.~      Patients undergoing Cesarean sections following failure to progress in labor are at great~     risk for PPH and should theoretically benefit from an additional uterotonic agent. This study~     will be conducted to define whether the addition of ergonovine maleate to oxytocin,~     administered in a prophylactic way, reduces blood loss during Cesarean section for failure to~     progress in labor.~   "
234875|NCT00481520|"~     The primary purpose of the study is to assess whether SAM-531, an investigational drug, is~     safe and well tolerated, compared with placebo (a medically inactive substance), in subjects~     with mild to moderate Alzheimer's disease.~   "
234876|NCT00481507|"~     The purpose of this study is to determine the effectiveness of commercially available kefir~     on preventing antibiotic-associated diarrhea compared to placebo in children ages 1-5.~   "
234877|NCT00481494|"~     Personality traits may influence to the drug compliance in glaucoma patients.~   "
234878|NCT00481481|"~     Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based~     immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin~     based immunosuppressive regimen.~   "
234879|NCT00481468|"~     We are evaluating a new computer software package to help us acquire and interpret heart CT~     studies, which is the purpose of this research project. We plan to compare the acquiring and~     analysis of heart artery calcium scores and CT angiograms (scans of the heart arteries) with~     the new SYNGO Somaris/7 Cardiac software to our previous experience with the the existing~     Siemens software and the TeraRecon software (current software used in the Cardiovascular~     MR/CT lab). The main objective of this study is to provide information to Siemens regarding~     the ease of use and capability of the scanner's software. The goal of this study is to~     determine whether the acquisition and interpretation information with the new software~     functionally meets the guidelines specified by Siemens, and also to determine whether the~     software is equivalent or superior to previous versions we used from April 2004 to April~     2006.~   "
234880|NCT00481455|"~     The purpose of this study is to evaluate the anti-tumor activity and safety of Panzem NCD~     given in combination with daily oral fixed-dose temozolomide in patients with recurrent~     glioblastoma multiforme.~   "
234881|NCT00481442|"~     Clinical studies evaluating the clinical use of phenylephrine in septic shock are lacking.~     The present study was designed to compare the effects of norepinephrine and phenylephrine on~     systemic and regional hemodynamics in patients with catecholamine-dependent septic shock.~   "
234882|NCT00481429|"~     Hypothesis:~      A cluster of biochemical measurements (biomarkers) predict which diabetic patients will~     respond to treatment with a therapeutic dose of rosiglitazone over a 12 week treatment~     period.~      Brief Summary:~      The purpose of this study is to assess the predictive value of the biomarkers in diabetic~     patients treated with a full dose of a thiazolidinedione (eg 4mg bid rosiglitazone) for 12~     weeks.~      Specifically - the questions asked are:~        1. Do baseline measurements of a selected panel of biomarkers predict the patients'~          response to rosiglitazone over 12 weeks?~        2. How does the panel of biomarkers change over that 12 week treatment period?~   "
234883|NCT00481416|"~     The purpose of the study is to access the accuracy of the PillCam Eso capsule in identifying~     the presence of suspected esophageal disease in patients undergoing surveillance or screening~     for esophageal disease by standard endoscopy~   "
234884|NCT00481403|"~     Sperm analysis following World Health Organization guidelines is unable to explain the~     molecular causes of male infertility when basic sperm parameters are within a normal range~     and women do not present gynaecological pathology.~      Subsequently, there is a need for accurate diagnostic tools in this sense and microarray~     technology applied to sperm analysis emerges as a promising field~   "
234885|NCT00481390|"~     This study is a cross-sectional observational study to evaluate the prevalence of HLA-B*5701~     in the European area and in major European ethnotypes.~      Any HIV-1 infected patient will be eligible for this study including treatment naïve and~     experienced patients, as well as patients previously tested for HLA-B*5701. Patients will be~     approached during a standard clinic visit, and will be consented prior to any study specific~     procedure. They will be asked to provide a tissue sample (cheek cells and blood sample) which~     will be used to assess HLA-B*5701 status by local and central laboratories.~      In selected sites patients may be asked to provide an additional blood sample. This sample~     will be used to develop and validate different methodologies for assessing HLA-B*5701 status.~   "
234991|NCT00479986|"~     The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone~     (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well~     as the degree of activation of the immune system, when given on top of an anti-diabetic~     treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic~     control.~   "
234886|NCT00481377|"~     The aim of this study is to assess the role of ablation in appropriate ICD interventions~     reduction in patients with coronary artery disease. The group will consist of 200 patients~     with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The~     patients will be randomized into ablation arm and conventional treatment. Number of~     appropriate ICD interventions is the primary endpoint of this study. All patients will have~     control follow-up visits every 3 months. The follow-up will be based on ICD memory.~   "
234887|NCT00481364|"~     This prospective, randomized, controlled study aims to investigate the effects of~     atorvastatin treatment in hemodialysis patients concerning progression of coronary artery~     calcification, progression of carotid artery intima-media thickness, endothelial function,~     and inflammation.~   "
234888|NCT00481351|"~     Effects of statin and ezetimibe association on kinetics of artificial chylomicrons in men~     with stable coronary heart disease (CHD).~      Background:~      The rate (kinetics) of chylomicrons removal from circulation have been correlated with the~     incidence and severity of atherosclerotic lesions; a number of studies demonstrated lower~     plasmatic clearance of chylomicrons in patients with CHD compared to patients without this~     condition. It was also demonstrated a correlation among LDL-C levels and removal of~     chylomicrons remnants by a technique employing artificial chylomicrons.~      The investigators also know that higher doses of more potent statins are more effective in~     chylomicrons removal than lower doses or less potent statins; nevertheless, the effect of the~     isolated use of statin has not been completely studied up to now.~      Study design:~      The investigators propose to study 26 outpatients volunteers with chronic CHD, followed at~     the Heart Institute - INCOR - of the School of Medicine, University of São Paulo.~      Following a period of six weeks of washout from any cholesterol reducer, the kinetics of~     chylomicrons removal by a technique of emulsion of radiolabeled artificial chylomicrons will~     be evaluated. Lipid fractions, hepatic enzymes and CK will be measured. Initially patients~     will be randomly allocated to receive simvastatin 20 mg /day (n= 13) or ezetimibe 10 mg/day~     (n=13) for six weeks. At the end of this period, kinetics of chylomicrons removal and~     laboratorial measurements will be repeated (Period 1).~      In the next period (Period 2) patients will receive simvastatin 20 mg/ ezetimibe 10 mg (n=13)~     or simvastatin 80 mg (n=13) for additional six weeks; at the end of this period, the~     evaluations will be repeated (third and last evaluation).~      The aim of this study is to further understand chylomicrons metabolism in patients with~     chronic coronary disease receiving cholesterol reducers at different dosage regimes.~   "
234889|NCT00481338|"~     The aim of the project is to assemble and to follow on a 10-year period a nationwide~     representative sample of lower limb OA patients.~      General objectives: To document the natural history and to identify predictive factors of the~     evolution and consequences of hip and knee OA in terms of pain, functional disability,~     structural damage, quality of life, autonomy, medical and health care use and cost of~     disease.~   "
234890|NCT00481325|"~     The purpose of this study is to learn about the safety and efficacy of pexacerfont in~     outpatients diagnosed with Generalized Anxiety Disorder~   "
234891|NCT00481312|"~     Patients in ICU who need help with their breathing are put onto a machine called a ventilator~     and are also given a medicine, called a sedative, which helps them to sleep and makes them~     more comfortable. Midazolam is a sedative that is routinely used for these purposes.~      For most patients the aim of sedation is to make them sleepy but still able to respond to~     nursing staff (light sedation)~      Dexmedetomidine is a new sedative for use in intensive care and in this clinical study,~     dexmedetomidine is compared to midazolam. It is thought that dexmedetomidine might be~     slightly better at allowing patients to be sleepy but still respond to people around them. It~     also does not appear to affect patient's breathing. the purpose of this study is to test~     whether dexmedetomidine really does have these advantages compared to midazolam.~      in this study we hope to show that: dexmedetomidine is at least as good as midazolam in~     helping patients to sleep better and making them more comfortable, and that they are able to~     co-operate better with the staff treating them, and that patients treated with~     dexmedetomidine require a shorter time on the ventilator than those treated with midazolam.~   "
234892|NCT00481299|"~     Prolactin is suggested to influence insulin resistance, but scarce data is available on the~     metabolic profile of patients with prolactinoma.~      The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with~     prolactinoma treated with dopamine agonists and to study the influence of disease control and~     anthropometry on their metabolic profile.~   "
234893|NCT00481286|"~     The purpose of this study is to determine if group clinics help older veterans change~     behaviors with the goal of improving diabetes outcomes.~   "
234894|NCT00481273|"~     This registry is a prospective, multi-center, observational study compiling data on the~     natural history and management of patients receiving Vidaza, and will provide unique insights~     into the management of myelodysplastic syndromes (MDS) and other hematological disorders and~     the impact of these disorders on patients.~   "
234895|NCT00481260|"~     Hgb C is an hemoglobinopathy quite rare in Israel. The clinical status of patients that are~     diagnosed as homozygous to this disease is quite benign but not study in large groups.~      Also the characteristics of carriers and the incidence in northern Israel were a large arab~     population lives, was not study. The results of this study can be useful for screening~     purpose in a area were another hemoglobinopathies are frequent.~   "
234896|NCT00481247|"~     The purpose of this clinical research study is to compare the confirmed complete cytogenetic~     response of dasatinib with that of imatinib within 12 months after randomization in patients~     with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety~     of this treatment will also be studied.~   "
234897|NCT00481234|"~     Patients with underlying cardiovascular disease are at high risk of perioperative~     cardiovascular events and death. Hemodynamic variables are controlled by the autonomic~     nervous system reflected by Heart Rate Variability. To investigate whether differences of HRV~     parameters predict perioperative cardiovascular events.~   "
234911|NCT00481052|"~     Treating Ph pos CML with Imatinib is very effective since the majority of the patients~     achieve a complete cytogenetic response and a major molecular response and are alive and~     progression-free after 5 years. However, the great majority of responding patients are not~     leukemia-free and may be at risk of progression, molecular, cytogenetic and clinical, at any~     time. In case of disease progression due to Imatinib failure, nilotinib has been found to be~     very effective, as expected from the preclinical profile of the drug, that is much more~     potent against BCR-ABL and inhibits nearly all the imatinib-resistant BCR-ABL mutants. For~     these reasons, nilotinib is going to be registered for the treatment of imatinib-resistant~     CMl patients. For the same reasons, nilotinib is expected to be more efficient than imatinib~     also front-line, based on the principle that we should aim at preventing the emergence of~     resistance better that at treating resistance once it has emerged. This expectation can be~     tested safely, because the toxicity profile of Nilotinib may be even more convenient than~     that of Imatinib, due to the lower frequency of edema and fluid retention.~   "
234898|NCT00481221|"~     β thalassemia is an autosomal recessive hemoglobinopathy and considered as the most~     widespread genetic mutation. According to the World Health Organization (WHO) between 1.5-7%~     of the world population are carriers for this disease, and every year 60,000-400,000 birth of~     new patients are reported. In Israel, the incidence of carriers for β thalassemia is around~     20% among the Jewish from Kurdish origin and around 5-10% among the Arab population.~      β thalassemia is a severe disease which requires many resources, both medical and financial.~     The disease is expressed by chronic hemolytic anemia which requires regular blood~     transfusions every 3 weeks. As a result of the blood transfusions and the iron absorption by~     the digestive tract, those patients suffer from severe hemosiderosis which is the main~     mortality cause in the disease, mainly in the second decade for life. Daily treatment with~     iron chelator is required. Moreover, despite the actual treatment, the quality of life of~     those patients is still low.~      Therefore the implementation of a prevention program which includes finding an effective and~     inexpensive way for identifying the β thalassemia carriers is a humanitary and publicly~     important goal.~      In β thalassemia carriers, laboratory tests will show hypochromic microcytic anemia. Those~     findings are similar in iron deficiency anemia, but the RBC number and the RDW are normal in~     thalassemia carriers.~      Few researchers tried in the past to determine cutoff point for diagnosis of β thalassemia~     carriers by different formulas.~      We used the algorithm SVM (support vector machine) to find a reliable formula that can~     separate patients with Iron deficiency anemia/ healthy from patients with β thalassemia minor~     (carriers). This formula can be inserted to any automatic blood counter and search for~     suspected carriers without deliberately intention and without any further blood test.~   "
234899|NCT00481208|"~     Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow may~     have distinctive patterns in medically well-controlled open-angle glaucoma patients. In the~     results, we found a unique pattern, 'Latent asymmetric IOP', defined as the IOP which differs~     between the eyes only when placed in the supine position. Unique effects of this latent~     asymmetric IOP on Visual field and diurnal IOP fluctuations were studied.~   "
234900|NCT00481195|"~     The primary objective of the study is to determine if armodafinil treatment, at a dosage of~     150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are~     experiencing a major depressive episode associated with Bipolar I Disorder and who are~     inadequately responsive to their current treatment for a current major depressive episode.~   "
234901|NCT00481182|"~     To assess the combined effects of fosamprenavir 700mg BID + ritonavir 100mg BID +~     standardized dose of methadone, on plasma total and unbound methadone enantiomer~     pharmacokinetics (PK), opiate pharmacodynamic (PD) measures, and safety. The effect of~     methadone on plasma amprenavir PK will also be assessed by comparison to historical control~     data.~   "
234902|NCT00481169|"~     The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an~     investigational drug, is safe and effective in the prevention of osteoporosis in~     postmenopausal women.~   "
234903|NCT00481156|"~     The purpose of this study is to examine behavioral and functional brain changes occuring as a~     result of cognitive remediation training in patients with schizophrenia. Extension and~     specificity of related changes will also be examined.~   "
234904|NCT00481143|"~     The purpose of this study is to investigate the effects of iron chelation using deferasirox~     in low and INT-1 risk (referring to the international prognostic scoring system, IPSS) MDS~     patients who show signs of iron overload due to repeated blood transfusions.~      This trial is not recruiting patients in the United States.~   "
234905|NCT00481130|"~     Over the past 30 years much has been learned about the molecular genetics and natural history~     of familial forms of hematuria. However, the enhanced understanding of these conditions has~     yet to generate effective therapies for Alport syndrome, the form of familial hematuria~     associated with end-stage renal disease. Males with Alport syndrome inevitably develop~     end-stage kidney failure, with a 50% likelihood of dialysis or kidney transplantation by age~     25 years. There is no proven treatment for Alport syndrome, although studies in animals have~     suggested several promising potential therapies. Potential drug treatments that might delay~     or prevent the development of kidney failure exist, but need to be evaluated through clinical~     trails. Conducting clinical trails for proposed treatments for Alport syndrome present many~     challenges. Because Alport syndrome is not a common disease, informative clinical trials will~     require the collaboration of investigators at multiple centers.~      The University of Minnesota, Department of Pediatrics, proposes to create the Alport Syndrome~     Treatments and Outcomes Registry (ASTOR) in order to facilitate clinical trials for the~     treatment of Alport Syndrome. This registry will be the first of its kind in North America.~     Because Alport syndrome is a rare disorder, recruitment of sufficient participants for~     meaningful therapeutic trials will require a multicenter effort. The primary objective of~     establishing and sustaining this registry is to enable clinical natural history studies and~     therapeutic trials to be conducted in children and adolescents with Alport syndrome.~   "
234906|NCT00481117|"~     This study intends to evaluate how safe and well tolerated the LY2405319 compound is when~     given to people for 7 days (in Part 1) and 28 days (in Part 2). This study intends to also~     determine if there is a positive effect on lowering the level of glucose in people with type~     2 diabetes.~   "
234907|NCT00481104|"~     Purpose of the study is to evaluate the long term safety of tesofensine in obese patients~   "
234908|NCT00481091|"~     The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of~     ABT-263 under two different dosing schedules with the objective of defining the dose limiting~     toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263~     at the defined recommended Phase 2 dose to obtain additional safety information and a~     preliminary assessment of efficacy. The Extension Study portion will allow active subjects to~     continue to receive ABT-263 for up to 7 years after the last subject transitions with less~     frequent study evaluations.~   "
234909|NCT00481078|"~     This randomized phase II trial is studying carboplatin, paclitaxel, and vorinostat to see how~     well they work compared with carboplatin, paclitaxel, and a placebo in treating patients with~     stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as~     carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether giving carboplatin and paclitaxel together with vorinostat is more effective than~     giving carboplatin and paclitaxel together with a placebo in treating non-small cell lung~     cancer~   "
234910|NCT00481065|"~     This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a~     seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007~     influenza season in the Southern Hemisphere.~   "
249520|NCT00286455|"~     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily~     (QD), in adults with type 2 diabetes.~   "
234912|NCT00481039|"~     Sickle cell anemia and sickle cell thalassemia are frequent diseases among the israeli arab~     population. The purpose of this study is to assess the clinical characteristics of the~     patients in one arab village and the laboratory characteristics in the carriers of this gene~     based in the screening for pregnant women that is carried out in the population of northern~     Israel.~      The results can be useful in order to institute universal screening for sickle cell anemia in~     northern Israel.~   "
234913|NCT00481026|"~     The project will investigate the use of a novel technique, transcranial direct current~     stimulation (tDCS) in the treatment of patients with schizophrenia and patients with~     depression. tDCS involves the application of an extremely weak continuous electrical current~     to the brain through the placement of anode and a cathode on the scalp. The electrical~     current is generally completely imperceptible after initial period of tingling which takes~     about 30 seconds. Stimulation under the anode appears to increase brain activity where as~     stimulation under the cathode has the opposite effect. This research plan involves two~     clinical trials:~        1. A study using tDCS to treat both the positive and negative symptoms of schizophrenia.~          The negative symptoms of schizophrenia such as lack of motivation and energy appear to~          arise due to a lack of activity in frontal brain areas. Positive symptoms such as~          hallucinations and confused thoughts may arise through over activity of brain areas more~          on the side and towards the back of the brain called the temporal cortex. We plan to~          apply tDCS such that it can simultaneously increased activity in these frontal brain~          areas and reduce activity over temporal cortex. We will compare active stimulation to a~          placebo condition which involves turning the stimulator off after 30 seconds. The~          capacity to target multiple symptom clusters is unique with this type of brain~          stimulation.~        2. The study using tDCS in treatment resistant depression builds on a work with~          transcranial magnetic stimulation (TMS). TMS techniques in depression seem to work which~          increased left frontal brain activity or decrease right frontal brain activity. tDCS~          will be used to do the same thing with the anode used to increase left-sided brain~          activity and the cathode used to simultaneously decreased right-sided brain activity.~      tDCS is potentially a better tolerated procedure than TMS and does not appear to have the~     same risk of seizure induction. Importantly, the equipment is quite inexpensive and this may~     prove to be an extremely safe and effective low-cost treatment for psychiatric disorders in~     Third World countries.~   "
234914|NCT00481013|"~     The primary objective of this proposal is to determine whether oral VPA is effective in~     treating SMA in adult patients.~   "
234915|NCT00481000|"~     The purpose of this study is to determine whether Dialectical Cognitive Traumatherapy is~     effective in the treatment of severe and chronic Posttraumatic Stress Disorder (PTSD)~     following childhood sexual abuse.~   "
234916|NCT00480987|"~     The goal of this clinical research study is to find the highest tolerable dose of oxaliplatin~     combined with fludarabine plus cytarabine that can be given to patients with Acute Myeloid~     Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS). Once the highest tolerable dose~     of oxaliplatin in this drug combination is found, the next goal of the study will be to learn~     the safety and the ability of the drug combination to control the disease.~   "
234917|NCT00480974|"~     Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with~     significant decrease in the frequency of vaso-occlusive crises and other crises related to~     SCA. Several studies were published with relative short term follow up in pediatric and young~     adult age. The purpose of this study is to assess the long term follow up in a group of~     patients that initiated Hydroxyurea treatment in childhood.~   "
234918|NCT00480961|"~     This research study was designed to test the safety and effectiveness of autologous stem cell~     graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with~     ischemic etiology. Cellular implantation will take place during off-pump revascularization~     surgery or during an ad hoc procedure using a mini-thoracotomy access.~   "
234919|NCT00480948|"~     The purpose of this study is to demonstrate the efficacy of infant formula having proportion~     of palmitate in the sn-2 position comparable to human milk in Chinese term infants.~   "
234920|NCT00480935|"~     Study Hypothesis: Patients with local renal cell carcinoma who are treated neoadjuvantly with~     Sutent may show a radiologic response to the study drug (Sutent).~      The study is looking at the neoadjuvant (pre-surgery) administration of Sutent in patients~     with localized kidney cancer. The purpose of this research is also to evaluate both the~     safety and effectiveness of Sutent in this patient population.~   "
234921|NCT00480922|"~     There has been a recent increase in incidence of obesity and its associated morbidities,~     including T2 DM, hypertension and hepatic steatosis. Hepatic steatosis is a precursor to~     non-alcoholic steatohepatitis, cirrhosis and end-stage liver disease. The 1st reported case~     of pediatric hepatic steatosis was in 1980 and it is now affects 30-77% of overweight~     children. In addition to its association with obesity, hepatic steatosis has been associated~     with the metabolic syndrome, insulin resistance, and post-prandial hyperglycemia. Current~     treatment of hepatic steatosis includes weight loss with a hypocaloric low fat diet. Given~     the association with insulin resistance and post-prandial hyperglycemia, adult patients with~     hepatic steatosis that does not respond to weight loss are placed on insulin sensitizing~     drugs. We hypothesize that weight loss with a diet designed to decrease insulin resistance~     and post-prandial hyperglycemia, a low glycemic load diet, will provide a safe and effective~     way to decrease hepatic fat content in the pediatric population. This hypothesis will be~     tested with a randomized control trial comparing the effect of a low fat diet with a low~     glycemic load diet.~   "
234922|NCT00480896|"~     A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial~     twice daily treatment and subsequent twice weekly prophylactic application can effectively~     treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.~   "
234936|NCT00480714|"~     To assess the immunogenicity of M. bovis BCG (SSI strain), given intrademally in the standard~     dose used in clinical practice and to measure the development of the immune response in the~     first six months after administration. M. bovis BCG is a fully licensed vaccine that has been~     in routine clinical use for the last 50 years. It is the most widely administered vaccine in~     the world today and has an excellent safety record.~   "
234937|NCT00480701|"~     The underlying goal of this study is to assess 123-I IBVM SPECT imaging as a tool to assess~     cholinergic transporter binding in the brain of AD and PD research participants and age- and~     gender-matched healthy subjects.~   "
234938|NCT00480688|"~     To assess the immunogenicity of M. bovis BCG, given intrademally in the standard dose used in~     clinical practice and to measure the development of the immune response in the first six~     months after administration. M. bovis BCG is a fully licensed vaccine that has been in~     routine clinical use for the last 50 years. It is the most widely administered vaccine in the~     world today and has an excellent safety record.~   "
235036|NCT00479349|"~     To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an~     investigational drug, in healthy Japanese young male and elderly subjects.To provide the~     pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in~     healthy Japanese young male and elderly subjects.~   "
234923|NCT00480883|"~     Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries,~     that has shown an increasing incidence over the last many decades. For the last 60 years~     antimony compounds are considered the treatment of choice. Though their use is expensive,~     cumbersome, has many adverse effects and not effective in all patients, the search for a~     better alternative is still going on. Low dose antimony compounds in combination with several~     agents have shown promise of reducing adverse effects of antimony compounds without~     compromising efficacy. Allopurinol is one such agent which though promising lacks randomized,~     controlled trials to prove efficacy. The main objective of this study is to evaluate low dose~     sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium~     stibogluconate in terms of efficacy and adverse effects.~      Methods and design: A multi-center randomized, controlled trial including 620 patients from~     endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research~     question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study.~     After evaluating the inclusion/exclusion criteria patients will be randomized to receive~     either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a~     maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and~     allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During~     treatment patients will be admitted to hospital and monitored daily for the presence of~     adverse effects. Follow up period will last six months during which patients will visits the~     research centers for assessment of healing process at monthly intervals.~   "
234924|NCT00480870|"~     The purpose of this study is to determine the effects of the anticholinesterase drug~     donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters~     will be analyzed by polysomnography.~   "
234925|NCT00480857|"~     The main purpose of this study is to try to find out whether adding chemotherapy to the~     standard treatment for your stage of prostate cancer is more effective than the standard~     treatment by itself. The kind of treatment that most physicians would consider standard for~     this stage of prostate cancer is radiation therapy alone, possibly in combination with~     hormonal therapy. In this study, all patients will receive chemotherapy and radiation~     therapy. It is hoped that chemotherapy will be found to provide additional benefit, but~     chemotherapy has significant side effects. The use of chemotherapy is experimental in~     prostate cancer; it needs to be tested to determine if it is beneficial and to find out more~     about the side effects of the two different treatments. This study is to determine the~     effects, good and/or bad, of adding chemotherapy to radiation therapy as salvage treatment~     for recurrent prostate cancer after surgery.~   "
234926|NCT00480844|"~     In this study we intend to compare the effect of Sertindole to that of Risperidone on~     cognitive impairment in schizophrenia.~      Hypothesis: Sertindole will be as effective as Risperidone for treating cognitive impairment~     in schizophrenia and with fewer side effects.~   "
234927|NCT00480831|"~     This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a~     background of effective treatment designed to evaluate the efficacy, safety, and~     pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in~     patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung~     cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.~   "
234928|NCT00480818|"~     To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an~     investigational drug, in healthy young adult and elderly subjects.To assess the~     pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in~     healthy young adult and elderly subjects.~   "
234929|NCT00480805|"~     A study to test the safety and efficacy of HYZAAR as compared to Ramipril in patients with~     type 2 diabetes mellitus (high blood sugar) and hypertension (high blood pressure).~   "
234930|NCT00480792|"~     In HIV infected patients, individuals exposed to the virus of Hepatitis B are more~     susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and~     liver cancer.~      However, the existing protocol of vaccination against Hepatitis B is less efficient in~     HIV-infected patients than in non HIV-infected-patients, and, in case of response, its~     longevity has to be followed up carefully. This study compares the efficacy of the standard~     protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a~     set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4~     level above 200 permm3.~   "
234931|NCT00480779|"~     The purpose of this study is to examine different methods of delivering the Group Lifestyle~     Balance (GLB) intervention (1). The GLB is a 12-week lifestyle change program based on the~     highly successful lifestyle program that was used in the Diabetes Prevention Program~     (DPP)(2). A DVD of the Group Lifestyle Program has been developed. Conditions called~     metabolic syndrome and pre-diabetes increase the risk of diabetes and heart disease. Recent~     research has shown that type 2 diabetes and metabolic syndrome may be prevented or delayed by~     making lifestyle changes. A primary care practice will enroll participants who will choose~     either the GLB-DVD intervention or face-to-face group delivery. Approximately 25 patients~     will be recruited in each group. It is not known if the GLB intervention delivered via DVD is~     similarly effective to face-to-face group delivery for people with metabolic syndrome or~     pre-diabetes. It is hoped that this research study will provide information to help answer~     that question.~   "
234932|NCT00480766|"~     A research study to see how safe and effective MK0217 is when taken weekly for the prevention~     and treatment of steroid induced bone loss.~   "
234933|NCT00480753|"~     The purpose of this clinical study is to determine the response to two different dosage~     strengths of a topical nitroglycerin gel in patients with Raynaud's Phenomenon. Patient~     fingers will be monitored for changes in blood flow and skin temperature. Symptoms of pain,~     tingling and numbness will also be monitored.~   "
234934|NCT00480740|"~     The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and~     pharmacogenomics of dexmedetomidine in the following three pediatric patient populations:~     patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who~     have had a cardiac transplant, and patients with otherwise normal physiology who are~     undergoing closure of a patent ductus arteriosis or atrial septal defect.~   "
234935|NCT00480727|"~     The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain,~     pin loosening and pin replacement.~   "
234939|NCT00480675|"~     The goals of our research project are to study the relationship, if any, between the success~     of a TB injection (measured by pain relief and general patient satisfaction) and the method~     in which it was placed. Because fluoroscopy places patients requires a slight risk from~     radiation exposure and increased cost versus blind injection, it is important to know if~     there is an advantage to using this technique. The investigators will randomize 64 patients~     to receive either trochanteric bursa injections with corticosteroid and local anesthetic~     guided by fluoroscopy, or trochanteric bursa patients to receive trochanteric bursa~     injections based on landmarks on palpation. The investigators will then determine which~     method is superior, and whether injecting steroid and local anesthetic into the bursa itself~     is superior or inferior to injecting it into a tender area outside the bursa.~   "
234940|NCT00480662|"~     To test the safety, effectiveness of MK0217 when taken once a week for six months in treating~     patients with Paget's bone disease.~   "
234941|NCT00480649|"~     The primary study objective is to demonstrate the clinical effectiveness of SERETIDE therapy~     compared to the current care in management of moderate to severe persistent asthma patients~     in Korea.~   "
234942|NCT00480636|"~     To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein~     thrombosis with or without pulmonary embolism in cancer patients.~   "
234943|NCT00480623|"~     This study is designed to measure the impact of Satraplatin plus radiation therapy to the bed~     of the prostate in patients who have developed biochemical failure of their prostate cancer.~     The main objective of this study is to determine the maximum tolerated dose and dose limiting~     toxicity for the combination of satraplatin and radiation therapy and to determine the~     recommended dose for subsequent Phase II trials.~   "
234944|NCT00480610|"~     Long-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice~     daily treatment and subsequent twice weekly prophylactic application can effectively treat~     active lesions of atopic dermatitis and prevent delay & reduce flares~   "
234945|NCT00480597|"~     Development of an active second-line treatment option for metastatic breast cancer patients~     previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative~     settings.~      For each randomisation arm, 47 patients will be included. The trial was performed as a~     2-stage phase II study according to the optimal design by Simon with overall response rate as~     the primary objective.~      Study Design:~      Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks~      Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks~      Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks~   "
234946|NCT00480584|"~     This is a phase I clinical trial examining the safety, feasibility, and toxicity of~     gemcitabine and erlotinib when given in combination with capecitabine in adult patients with~     locally advanced unresectable or metastatic pancreatic adenocarcinoma.~      Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine~     once per week for 3 weeks, followed by a week off treatment. Erlotinib (tablet) taken by~     mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on~     days 1-14 of each cycle followed by a 2 week off treatment rest period. An accelerated~     dose-escalation scheme will be employed with 4 planned dose levels. Whenever patients have~     been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose~     will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended~     phase II dose (RPTD) to confirm tolerability at that dose.~      In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles~     or until disease progression and patients may continue on the study regimen unless they~     experience an adverse event that meets the criteria for a dose limiting toxicity.~   "
234947|NCT00480571|"~     An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety~     and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic~     schizophrenia or schizo-affective disorder~   "
234948|NCT00480558|"~     This study is designed to evaluate the safety of MVA85A in asymptomatic volunteers in South~     Africa who are infected with M.tb, HIV or both. A single vaccination with MVA85A, when~     administered at a dose of 5 x 107pfu intradermally, is safe and highly immunogenic in~     mycobacterially naïve individuals, BCG vaccinated individuals and M.tb latently infected~     individuals. We will use the same vaccination regime in this study. Participants will be~     defined as being infected with M.tb.if they have a positive Elispot response to ESAT6 or~     CFP10. Participants will be defined as being infected with HIV.if they have a positive HIV~     rapid test (Determine®, Abbott Laboratories) followed by a positive HIV ELISA result.~     Participants will be identified from the general population living in Worcester, Western~     Cape, South Africa~   "
234949|NCT00480545|"~     Indirect evidence suggests that hormonal fluctuations during the menstrual cycle also affect~     the bleeding and clotting system. This study looks at two sensitive laboratory tests at four~     time points during the menstrual cycle to determine if there is a natural variation in~     coagulation and platelet function. Laboratory tests in healthy subjects will be compared to~     women with von Willebrand's disorder type 1, a bleeding disorder. In the future, these~     laboratory tests may help in the diagnosis of bleeding and clotting disorders and to design~     treatments for women with abnormal menstrual bleeding.~   "
234950|NCT00480532|"~     The purpose of this study is to learn if the study drug, doxycycline, can decrease the amount~     of unplanned vaginal bleeding that women commonly experience when taking combined oral~     contraception (COC)- pills with estrogen and progestin - in a continuous fashion - no~     hormone-free week. The study drug, doxycycline, is an antibiotic used commonly for many~     conditions (i.e. acne, Chlamydia infections, pneumonia) and can be safely used on a daily~     basis. Doxycycline has been shown to decrease unplanned vaginal bleeding in progestin-only~     contraception but has not been studied in combined hormonal contraception.~   "
234951|NCT00480519|"~     The aim of the study is to prospectively investigate the feasibility, pain control, and~     outcome of meatotomy performed under sedation and local anaesthesia compared with general~     anaesthesia with and without patient block~   "
234952|NCT00480506|"~     The purpose of this study is to collect peripheral blood and bone marrow aspirate samples~     from thalassemia patients in Tehran, in a collaborative effort to develop an erythroid~     lineage specific chimerism assay applicable to patients with thalassemia. Development of such~     an assay would be useful both for identification of the exact mutation causing the disease,~     as well as for providing a direct method to measure and monitor the kinetics of donor~     erythropoiesis in this patient population following transplant.~   "
234953|NCT00480493|"~     This RCT intervention provides parental social support (informational, affirmational, and~     emotional) using parent mentors (experienced in the management of the chronic illness) for~     mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent~     mentors provide both home visits and phone call support over the course of the first year~     after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention~     will perceive less parental concern and worry, less negative impact on the family, more~     perceived confidence and social support compared to those mothers and fathers not receiving~     the intervention.~   "
234954|NCT00480480|"~     Context: This is the first multi-site randomized controlled study of the effectiveness of a~     group treatment for war-exposed adolescents delivered in-country within a public school~     system.~      Objective: To evaluate the effectiveness of a trauma/grief-focused group treatment program in~     reducing symptoms of posttraumatic stress disorder (PTSD), depression, and traumatic grief in~     war-exposed Bosnian youths attending 10 secondary schools located in Central Bosnia.~   "
234955|NCT00480467|"~     To assess the safety and tolerability of ascending single oral doses of SAM-315, an~     investigational drug, in healthy Japanese male subjects.To obtain preliminary pharmacokinetic~     (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy Japanese male subjects.~   "
234956|NCT00480454|"~     This study is preliminary to proving that this vaccine could protect against tuberculosis in~     humans. Although there is no proven data to show that infants will benefit directly from~     participation in this study by being protected against TB, MVA85A protection of mice, guinea~     pigs and monkeys against tuberculosis is encouraging. It is hoped that the information gained~     from this study will contribute to the development of a safe and effective TB vaccine for HIV~     negative and positive individuals. Participants in this study will benefit by having~     information about their general health status, and the rigorous follow up visit that could~     enhance early detection and management of medical conditions that might arise in the course~     of the study.~   "
234957|NCT00480441|"~     This treatment study is targeted specifically for those who want to stop using marijuana. We~     want to find out if patients who are dependent on marijuana and want to stop using are helped~     by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA).~     Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol~     is approved for the treatment of nausea in people receiving cancer chemotherapy and as an~     appetite stimulant in people with AIDS.~      In some studies, dronabinol reduced the amount of psychological and physical discomfort~     experienced when people stopped using marijuana. One purpose of our study is to see if people~     who are on dronabinol have fewer problems with psychological and physical discomfort than~     those who are on a placebo.~      In addition to treatment, this research trial will also be measuring the reactions of~     subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We~     may examine whether the response to these cues/tasks either predicts treatment outcome, or is~     affected by your treatment. This information may also help us to understand the ways in which~     chronic drug use causes changes in our subjects' mental functioning and how those changes~     respond to treatment.~      In addition to participation in the treatment research trial, some subjects may be asked to~     undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure~     brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI~     (functional magnetic resonance imaging) in marijuana subjects before and after treatment with~     the medication dronabinol or with an inactive substance (placebo).~   "
234958|NCT00480428|"~     Residents of certain villages in Kazakhstan were exposed during childhood to radioactive~     fallout from nuclear tests conducted at the Semipalatinsk Nuclear Test Site (SNTS) between~     1949 and 1962.~      Radiation doses to the thyroid from external and internal (i.e., ingested) radiation sources~     deposited as fallout are of interest because they may be jointly and differentially~     associated with increased risk of thyroid disease in this population.~      Objectives:~      To collect information about factors influencing radiation dose to the thyroid gland in~     children of two ethnic groups who were exposed to radioactive fallout from nuclear tests at~     the SNTS between 1949 and 1962. The two groups are Kazakhs (historically nomadic herders) and~     Europeans (typically descendants of Russian and German farmers).~      Eligibility:~      Women 70 years of age and older who had children or provided care to children during the~     1950s.~      Men age 70 and older who were engaged in farming and care of dairy animals at the time of the~     nuclear tests.~      Design:~      In focus group format, participants are interviewed to collect information on the following~     at the time of nuclear tests:~        -  Dairy consumption;~        -  Source, storage and availability of milk and milk products;~        -  Time that children of different ages and ethnic groups spent indoors;~        -  Building material of houses and schools;~        -  Herding, grazing and supplemental feed of dairy animals.~   "
234959|NCT00480402|"~     To assess the effectiveness of natural progesterone supplementation in preventing preterm~     births in twins.~   "
234960|NCT00480389|"~     The purpose of this study is to see if preoperative administration of Sorafenib reduces the~     size of the primary kidney tumour in patients with metastatic disease undergoing~     cytoreductive surgery.~      The study will also assess the safety of preoperative Sorafenib.~      The study drug, Sorafenib, will be given to patients preoperatively for 12 weeks. After a 1~     week washout period the patient will then have their nephrectomy (kidney removed).~     Approximately 6 weeks following their nephrectomy, patients will resume on study drug until~     disease progression.~   "
234961|NCT00480376|"~     Prostate biopsy is usually conducted transrectal, ultrasonography guided. Since the area is~     not sterile, infection can be induced during the procedure.~      Prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of~     infections. Quinolones are considered preferred treatment but there is already an increase in~     resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant~     uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very~     low resistance rate in the community, high concentration is urinary tract, slow clearance, no~     resistance developed under treatment, chip and with very few side effects.~   "
234962|NCT00480363|"~     The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the~     time to progression to symptomatic MM in patients with smoldering MM. The second one is to~     evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to~     evaluate the safety and tolerability of the treatment~   "
234963|NCT00480350|"~     HIV infection is a growing problem in Israel with over 4000 known patients who are either~     infected with the virus or have developed AIDS. Patients are usually followed for years until~     they develop an increase in their viral load (HIV-1 RNA) or their CD4 + cells decline. At~     this point, patients are usually treated with Highly Active, Anti-Retroviral Therapy (HAART).~     The mainstay of response to such treatment is the lowering of viral load and increase in CD4+~     cells. Food supplements for HIV patients have been given in several studies, with~     controversial results. A meta-analysis published recently [1] assessed whether micronutrient~     supplements are effective in reducing morbidity and mortality in adults and children with HIV~     infection. They recommended supporting the current WHO recommendations to promote and support~     adequate dietary intake of micronutrients wherever possible. We expect to enroll 140 subjects~     in this randomized, double blind, placebo controlled study. Seventy subjects will be enrolled~     in the rice-supplement arm and 70 subjects in the control group, which will receive~     supplemental, flavored dextrose to their current medical treatment. The treatment duration is~     24 weeks with follow-up at 36 weeks from enrollment. The target population is HIV-1 infected~     individuals who may be either on anti-retroviral therapy or not on therapy. Subjects must be~     with either CD4+ cells are <500 cells/mm3, or HIV plasma RNA level is > 5000 copies/ml. The~     primary objective is to demonstrate the efficacy of food supplementation versus a~     flavored-dextrose supplement with respect to increment of patient CD4+ cell count from~     baseline at 24 weeks, or virological response defined as lowering of plasma HIV-1 RNA and~     immunologic response.~   "
234964|NCT00480337|"~     The aim of this study is to aspirate immature oocytes from antral follicles and mature the~     oocytes in vitro. These mature oocytes will serve for fertilization and the creation of~     embryos which will be replace in the uterus as performed during normal IVF.We will record the~     efficacy and safety of this procedure.~   "
234965|NCT00480324|"~     This study is undertaken to provide the regulatory authorities in Japan with immunogenicity,~     efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine,~     given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2~     months at the time of the first dose and previously uninfected with HRV. The Protocol Posting~     has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
234966|NCT00480311|"~     The main purpose of this study is to determine the measurement characteristics of WHODAS-II~     (World Health Organization Disability Assessment Schedule II), as well as to analyze its~     correlation with symptomatic lumbar spinal stenosis (Visual Analog Scale, VAS), disability~     (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and~     attitudes (Spanish version of the FAB Questionnaire, FABQ), and quality of life (SF-12).~     Measurements will be taken at baseline and 6 days later (day 7).~   "
234967|NCT00480298|"~     This study is a double-blinded, randomized, placebo controlled, multi-center trial in which~     120 subjects with nasal polyposis (NP) will be treated during 20 days with oral~     corticosteroids (OCS) in decreasing doses or oral doxycyclin (ODOX) or placebo. At each visit~     the clinical and the biological activity will be assessed by nasal peak inspiratory flow~     (nPIF), symptoms, olfactory test, endoscopic evaluation of nasal polyps, peripheral~     eosinophil levels and markers of inflammation IL-5, IL-5 receptor alpha, ECP, TGFβ1, IgE and~     specific IgE in serum and nasal secretion.~   "
234968|NCT00480285|"~     The aim of this study is to compare the effectiveness of laparoscopic Nissen against anterior~     partial fundoplication in the control of gastroesophageal reflux disease among Chinese~     patients~      Study hypothesis Laparoscopic Nissen is comparable to anterior partial fundoplication in the~     control of gastroesophageal reflux disease~   "
234969|NCT00480272|"~     Hypothesis: Early intensive treatment with anti-TNF agent plus methotrexate plus high dose~     prednisone may increase remission rate and may induce stable remission in Rheumatoid~     Arthritis Objective: to evaluate induction of remission using adalimumab, prednisone and~     methotrexate and maintenance of remission after discontinuation of adalimumab and prednisone~   "
234970|NCT00480259|"~     This study is designed to determine if the following are true. When protein requirements~     exceed metabolic requirements, blood urea nitrogen(BUN) levels will rise. Elevated BUN levels~     in the absence of renal failure, hepatic failure, or GI bleeding, will be correlated with~     improved nitrogen balance and inversely correlated with infection rates, days of mechanical~     ventilation, ICU days, and total hospital days.~   "
234971|NCT00480246|"~     This is a single dose, open-label, 2-panel (Parts A and B) PET study investigating the degree~     of occupancy of dopamine 2 receptors (D2_RO) in the human brain after single oral doses of~     BL-1020 or Perphenazine (Trilafon®, hereafter called Perphenazine) in healthy male subjects.~     In Part A the D2_RO is investigated for the study compound BL-1020 and in Part B the D2_RO of~     BL-1020 is compared to the D2_RO of Perphenazine, a reference compound.~   "
234972|NCT00480233|"~     Depression is common in primary care and general medical settings, but is often unrecognized~     and untreated by physicians working in those settings.~      The Patient Health Questionnaire for depression (PHQ-9) is well validated and widely used~     screening instrument.~   "
234973|NCT00480220|"~     The main objective of this work is to assess the feasibility and efficacy of a specific Care~     and Assistance Plan for Alzheimer's disease (PLASA). The main outcome measure selected is~     incapacity in carrying out the basic activities of daily living, evaluated by the ADCS-ADL~     scale .~      The PLASA was developed by a working group appointed by the Direction Générale de la Santé as~     part of the government programme of action on Alzheimer's disease (October 2001, Ministère de~     l'Emploi et de la Solidarité).~   "
234974|NCT00480207|"~     Our specific aim is to determine the impact of folic acid and omega-3 supplementation on the~     severity of depressive symptoms among depressed adults aged 65 and above.~   "
234975|NCT00480194|"~     The objectives of the study are to obtain knowledge about the safety in use, the patients'~     general impression of the treatment and the pattern of use of ZyComb® in an over-the-counter~     (OTC) setting.~   "
234976|NCT00480181|"~     The purpose of this study is to determine whether nabilone (Cesamet) when used as an~     adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief over~     gabapentin alone for the management of neuropathic pain in MS.~   "
234977|NCT00480168|"~     The purpose of this study is to observe patients aged 6-18 with various psychiatric diagnosis~     being treated with drugs called atypical antipsychotics to determine the effects of the drugs~     on growth, weight gain, and laboratory tests.~   "
234979|NCT00480142|"~     A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule~     Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia~     Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).~      CRO is indicated for the management of moderate to severe pain when a continuous,around the~     clock analgesic is needed for an extended period of time.Its safety and efficacy in the first~     12-24 hours post operative has not been established.~   "
234980|NCT00480129|"~     We hypothesize that specifically selected probiotics can alleviate symptoms of allergy in~     lactose tolerant individuals. Two strains of probiotics, Lactobacillus rhamnosus GR-1, and~     Bifidobacterium adolescentis 7007-05 will be used to create a yogurt product. Additionally a~     non-probiotic yogurt product will also be made as a placebo. Allergy sufferers will be asked~     to consume one of the two types of yogurts (blinded) for two months. During the two months~     there will be 3 sampling days, for blood samples and nasal lavage samples. Additionally Mini~     Rhinoconjunctivitis Quality of Life Questionnaires will be filled out weekly over the two~     months. After the two months of perceived responses as well sample analysis we should have a~     better idea of how these specific probiotic effect the immune system and allergies.~   "
234981|NCT00480116|"~     The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and~     immuno-compromised individuals who could have or had a sub-optimal response following~     vaccination for hepatitis B with currently available commercial vaccines (target population).~     This study will aim to confirm in a clinical setting the consistency of production of three~     lots of the vaccine.~   "
234982|NCT00480103|"~     We aim to compare the morphological and chromosomal features of human embryos cultured In~     Vitro versus those developed in a new In Vivo culture system with encapsulation in utero as~     well as implantation and pregnancy rate.~   "
234983|NCT00480090|"~     This is a single-arm, open label phase II trial of the investigational agent, Ara-C~     (cytarabine), in patients diagnosed with hormone refractory prostate cancer whose disease has~     progressed on or deemed not suitable for standard chemotherapy with docetaxel. Ara-C appears~     to inhibit DNA synthesis and is cytotoxic to a wide variety of mammalian cells. Recent~     discoveries have suggested the role of gene fusions in the ETS family of transcription~     factors as important for the development of prostate cancer. Ara-C appears to block ETS~     genes, suggesting that it is worthwhile to explore Ara-C as a potential new treatment for~     patients with hormone refractory prostate cancer given that there is no standard of care for~     the proposed patient population. In this study, Ara-C will be administered intravenously for~     2 days every 3 weeks (1 cycle). Treatment will be for 6 cycles if tolerated and may be~     continued in patients who are responding and do not have severe toxicity.~   "
234984|NCT00480077|"~     The DOT-HF trial is an international, prospective, multi-center, randomized, controlled~     trial.~   "
234985|NCT00480064|"~     A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and~     Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1).~     Patients in complete remission (CR) were then randomized to receive either maintenance~     therapy or intensification with intermediate-dose cytarabine and idarubicin followed by~     maintenance therapy.~   "
234986|NCT00480051|"~     Patients who have heart failure and have electrical evidence of delay in the contraction of~     the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing.~     Recent work has suggested that patients with heart failure who do not have electrical~     evidence of conduction delay (normal QRS) may benefit from biventricular pacing. The reliance~     on ECGs to determine the presence of dyssynchrony is widespread, although the ECG alone is~     not 100% sensitive and specific. ECG criteria for de-synchrony in heart failure patients are~     estimated to pick up only 30% of patients with dyssynchrony, and results in patients missing~     out on a potentially important treatment advance.~      We would like to study patients with heart failure who have normal ventricular activation on~     their ECGs to see whether we can predict those patients who will respond to biventricular~     pacing.~   "
234987|NCT00480038|"~     The main purpose of this study is to determine the measurement characteristics of WHODAS II~     (World Health Organization Disability Assessment Schedule), as well as to analyze its~     correlation with symptomatic lumbar disc herniation (Visual Analog Scale, VAS), disability~     (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and~     attitudes (Spanish version of the FAB Questionnaire, FABQ) and quality of life (SF-12).~     Measurements will be taken at baseline and 6 days later (day 7).~   "
234988|NCT00480025|"~     The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic~     product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of~     their tumor. A course of 13 injections will be administered over 27 months. The Protocol~     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
234989|NCT00480012|"~     Rapid Transcranial Magnetic Stimulation will be used in order to examine whether the human~     primary visual cortex is essential to visual memory consolidation.~   "
234990|NCT00479999|"~     This study will test whether two experimental HIV vaccines are safe and whether they cause~     any side effects in healthy adults. It will examine the body s immune response to the~     vaccines and monitor the social impact, if any, of being in an HIV vaccine study. The~     experimental vaccines in this study are the VRC-HIVADV027-00-VP (also called the rAd35-EnvA~     vaccine) and VRC-HIVADV038-00-VP (also called the rAd5-EnvA vaccine). The vaccines are made~     using an adenovirus (virus that normally causes respiratory infections and colds) that has~     been modified to contain DNA that codes for HIV proteins. The vaccines cannot cause HIV or~     adenoviral infections.~      Healthy normal volunteers between 18 and 50 years of age may be eligible for this 2-part~     study. Part 1 includes 15 people. Part 2 includes 20 people.~      Part 1 participants receive only the rAd35-EnvA vaccine. The first five people enrolled~     receive the lowest study dose of the vaccine. If this dose is safe, then the next five people~     enrolled receive a higher dose. If this dose is safe, then the last 5 people enrolled receive~     the highest study dose. Subjects in Part I have about five clinic visits over 24 weeks.~      Part II of the study starts after all injections in Part 1 are given. Subjects in Part 2 are~     randomly assigned to one of two vaccination schedules. One group receives the rAd35-EnvA~     vaccine first, followed 12 weeks later with the rAd5-EnvA vaccine. The other group receives~     the vaccines in reverse order; that is, first the rAd5-EnvA vaccine, followed 12 weeks later~     with the rAd35-EnvA vaccine. In this schedule, the first vaccination primes the immune system~     and then the immune response is boosted 12 weeks later with a different vaccine. Everyone in~     study Part 2 receives the rAd35-EnvA vaccine at the middle dose tested in Part 1. Subjects in~     Part 2 have about eight clinic visits over 36 weeks.~      All vaccinations are given as injections in the upper arm. At each clinic visit, participants~     are checked for health changes or problems. They are asked how they are feeling and if they~     have taken any medications. Urine samples are collected and blood is drawn at some visits.~     They are tested for HIV several times and asked questions about their sexual behavior and~     drug use. Throughout the study, participants are counseled on HIV risk reduction. Subjects~     are asked about any social effects they may have experienced from their participation in this~     study.~   "
235210|NCT00477022|"~     the objective of this study is to evaluate the impact of vacuum-compression effects of~     Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri’s~     principle in diabetic patients.~   "
234992|NCT00479973|"~     Introduction: According to the World Health Organization (WHO), approximately 150 million~     people worldwide have type 2 diabetes. Common and cassia cinnamon have been reported to have~     anti-diabetic and lipid-lowering effects.~      Objective: To determine if the combination common and cassia cinnamon product Cinnamonforce™~     (Cinnamomum verum and C. aromaticum) reduces fasting blood glucose, insulin, glycosylated~     hemoglobin (HA1C), triglyceride, total cholesterol, HDL cholesterol and LDL cholesterol~     levels in people with type 2 diabetes.~      Methodology: Seventy (70) type 2 diabetic participants will be randomized to receive either~     140 mg of Cinnamonforce twice daily or placebo over 12 weeks. Physical and laboratory~     measurements will be taken at baseline, 2 weeks, 4 weeks, 8 weeks and at the end of the~     trial, 13 weeks.~      Results: The differences in the measurements obtained from the group receiving Cinnamonforce~     and the placebo group will be analyzed and discussed.~   "
234993|NCT00479960|"~     The phospholipids of mammalian spermatozoa possess a distinctive fatty acid composition with~     high proportion of long chain polyunsaturated fatty acids. The lipid composition is a major~     determinant of the membrane flexibility and sperm motility required for proper fertilization.~     It also influences the sperm plasma membrane's fluidity, chilling sensitivity and~     thermotropic lipid phase transition (LPT) and these parameters determine our ability to~     cryopreserve these cells. Our hypotheses is that by providing dietary supplementation of~     omega-3 polyunsaturated fatty acids an improvement of sperm parameters (number, motility,~     viability) can be achieved. We also expect alteration spermatozoal plasma membrane fatty acid~     composition, making it more chilling resistant.~      Experimental methodology: 1) Characterize fatty acid composition of the spermatozoa of normal~     and abnormal spermatozoa by gas chromatography. 2) Characterize sperm plasma membrane LPT by~     FTIR spectrometer. 3) Run a randomized double-blind, placebo controlled, crossed-over dietary~     fatty acid supplementation pilot trial in human sub-fertile patients. Large scale trial will~     follow, if justified. In both trials sperm characterization of each participant will be~     conducted before, during and following the trial.~      Subfertile males will benefit greatly if their sperm parameters can be improved and~     cryopreserved while ensuring enhanced post-thawing survival. We believe that changing the~     fatty acid composition of sperm plasma membrane by simple dietary means will open the way to~     improve the fertility of those that needs it the most.~   "
234994|NCT00479947|"~     Yeast vaginitis is a very common ailment affecting premenopausal women in Nigeria. This~     condition is more prevalent in the age group between 21-30 years. More than 75% of~     premenopausal women and university students are diagnosed with yeast infections annually. In~     most of these women, recurrent rate of vaginal candidiasis with empiric therapy, stands~     between 70 and 80%. In addition, resistance to anti-fungal agents is increasing at an~     alarming speed, particularly with species other than Candida albicans such as C tropicalis~     and C glabrata. The healthy vaginal environment is composed mainly of lactobacilli and when~     these organisms are suppressed overgrowth of a large number of pathogens occur including~     yeasts. In this pilot study,we hypothesize that oral administration of two well documented~     strains of lactobacilli (L.rhamnosis GR-1 and L.reuteri RC-14 ) given to women with recurrent~     yeast vaginitis, following standard therapy with fluconazole will result in a significant~     reduction in recurrence rate of the disease.~   "
234995|NCT00479934|"~     In vitro studies have shown that imatinib 1mM inhibits strongly the growth of cutaneous~     fibroblasts. The hypothesis is that imatinib inhibits PDGFR which is known to be a potential~     target for the molecule, as recently also proposed after the discovery of autoantibodies~     activating the PDGF receptors. Recent data indicate that TGFb is also a potential target of~     imatinib. Cutaneous scleroderma is characterized by progressive cutaneous fibrosis caused by~     hyperactive dermal fibroblasts. Since no established treatment for skin sclerosis in~     scleroderma is currently available. This study will test the safety and efficacy of imatinib~     in the treatment of patients with scleroderma and severe cutaneous involvement.~   "
234996|NCT00479921|"~     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in~     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of~     these vaccines are required to be involved in ongoing clinical trials and to present the~     results to the competent authorities each year. The current study is a phase IIIa clinical~     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It~     is part of the ongoing clinical trial program for Influvac® and will be done to assess the~     immunogenicity and safety and tolerability of next season's trivalent influenza subunit~     vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects~     >= 61 years of age (elderly).~   "
234997|NCT00479908|"~     The purpose of the study is to determine for how long sildenafil potentiates the blood~     pressure reduction that occurs with glyceryl trinitrate in men with angina.~   "
234998|NCT00479895|"~     The test compound and subject of this clinical trial is the haemoglobin-based oxygen carrier,~     HBOC-201 (Hemopure). HBOC-201, initially developed as an alternative to red blood cells for~     surgical patients, has the ability to restore tissue oxygenation in persistently ischemic~     tissue. The development of this new class of compounds, referred to as oxygen therapeutics,~     provides an opportunity to test the safety and efficacy of a new approach to management of~     myocardial ischemia.~   "
234999|NCT00479882|"~     This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed~     dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on~     lipid values.~   "
235000|NCT00479856|"~     This study will evaluate the safety and efficacy of lapatinib in combination with~     chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing~     breast cancer whose disease has progressed during or within 12 months after completion of~     trastuzumab-containing therapy in the neoadjuvant or adjuvant setting.~   "
235001|NCT00479843|"~     The main objective of this study is the improvement of the quality of life and state of~     health of elderly people with cognitive deterioration and their families through a weight~     loss prevention programme.~      The secondary objectives are the improvement of the state of nutrition, a reduction in the~     use of resources and a reduction in the burden on the main carer.~   "
235002|NCT00479830|"~     The goal of this research study is to learn about the health practices, health knowledge, and~     attitudes of South Asian Americans who live in Houston or the surrounding area.~   "
249521|NCT00286442|"~     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily~     (QD), combined with metformin in adults with type 2 diabetes mellitus.~   "
235003|NCT00479817|"~     This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to~     estimate the improvement in PFS (compared to control subjects) and evaluate the safety and~     tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with~     advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.~      Primary Outcome Measure:~      • Progression free survival (PFS)~      Secondary Outcome Measures:~        -  Object Response Rate (ORR), duration of response (DOR). CA-125 response rate~        -  Safety and Tolerability~        -  Change and duration of change on blood levels of CA-125~   "
235004|NCT00479804|"~     The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac~     diseases. The current standard methods for the determination of the CO, however, are either~     invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic~     resonance tomography, MRT). The traditional non-invasive methods of determining the CO by~     rebreathing of carbon dioxide are easily carried out but suffer from methodical inaccuracies.~     Therefore the aim of the study at hand was to evaluate a new method for determining the CO by~     means of the inert gas rebreathing method.~   "
235005|NCT00479791|"~     A meal rich in very-long chain omega-3 fatty acids or oleic acid may lower postprandial~     insulin levels in comparison to a meal rich in linoleic acid or palmitic acid. A meal rich in~     very long-chain omega-3 fatty acids may lower postprandial triglyceride levels compared to~     other fatty acids.~   "
235006|NCT00479778|"~     The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is~     given in combination with 2 different formulations of conjugated estrogens. It is an open~     label study with no placebo control or comparator drugs. Subjects will take one dose of the~     investigation formulation daily for 14 days.~   "
235007|NCT00479765|"~     OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release~     of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long~     period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.~      The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed~     into the tumor resection cavity in the brain following surgical removal of the tumor. Dose~     escalation is conducted by gradually increasing the amount of OncoGel placed in the resection~     cavity in small groups of patients, and watching the patients closely for side effects before~     moving to the next dose level. The study will also test whether OncoGel helps to prevent or~     delay the tumor from regrowing.~   "
235008|NCT00479752|"~     To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in~     combination with cetuximab, biweekly.~   "
235009|NCT00479739|"~     To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of~     formoterol/budesonide where the dose is adjusted according to a physician-guided~     self-management plan~   "
235010|NCT00479726|"~     To assess the effectiveness of duloxetine administered once daily in patients with Major~     Depressive Disorder in a practice based setting~   "
235011|NCT00479713|"~     This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin~     versus rosuvastatin in participants with high cholesterol.~   "
235012|NCT00479700|"~     To assess the safety and tolerability of ascending single oral doses of SAM-531 in healthy~     subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of~     SAM-531, an investigational drug, in healthy subjects and to evaluate the effect of a~     high-fat meal on the PK of SAM-531 administered to healthy subjects.~   "
235013|NCT00479687|"~     This clinical trial is to determine the safety and effectiveness of three injections of~     SUPARTZ (sodium hyaluronate) compared with saline (placebo) for the treatment of glenohumeral~     osteoarthritis of the shoulder. The trial contains two phases. In the first phase subjects~     are randomized to either SUPARTZ or placebo treatment. The second phase of the trial is~     open-label so all subjects will receive SUPARTZ injections only.~   "
235014|NCT00479674|"~     Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane®~     (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and~     tolerability. When combined with a taxane, platinum agents improve response in metastatic~     breast cancer, with carboplatin conferring less toxicity than cisplatin. Monoclonal~     antibodies including bevacizumab target vascular endothelial growth factor (VEGF) to reduce~     angiogenesis. We hypothesize that the previously-untested combination of weekly Abraxane® and~     carboplatin plus biweekly bevacizumab will lengthen time to progression without producing~     intolerable toxicity.~   "
235015|NCT00479661|"~     Patients in the ICU who need help with their breathing are put onto a machine called a~     ventilator and are also given a medicine, called a sedative, which helps them to sleep and~     makes them more comfortable. Propofol is a sedative that is routinely used for these~     purposes.~      For most patients the aim of sedation is to make them sleepy but still able to respond to~     nursing staff (light sedation).~      Dexmedetomidine is a new sedative for use in intensive care and in this clinical~     study,dexmedetomidine is compared to propofol. It is thought that dexmedetomidine might be~     slightly better at allowing patients to be sleepy but still respond to people around them. It~     also does not appear to affect patient's breathing. The purpose of this study is to test~     whether dexmedetomidine really does have these advantages compared to propofol.~      In this study, we hope to show that: dexmedetomidine is at least as good as propofol in~     helping patients to sleep better and making them more comfortable, and that they are able to~     communicate and cooperate better with the staff treating them, and that patients treated with~     dexmedetomidine require a shorter time on the ventilator than those treated with propofol.~   "
235016|NCT00479648|"~     Current influenza vaccines have a reduced efficacy in the elderly. This study will~     investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in~     elderly participants.~   "
235017|NCT00479635|"~     The primary objective of the study is to determine the response rate to TPI 287 in patients~     with metastatic, hormone-refractory prostate cancer who have had one prior taxane regimen.~   "
235018|NCT00479622|"~     The purpose of this study is to determine how the body absorbs and chemically changes a~     single infusion of TRU-015 in subjects with kidney disease caused by lupus.~   "
235760|NCT00469664|"~     Our overall aim is to determine if the administration of guanfacine in combination with~     aripiprazole, olanzapine, quetiapine, and/or risperidone is significantly more effective than~     any of those medications alone in treating some of the cognitive impairment in schizophrenia.~   "
235019|NCT00479609|"~     Men with metabolic syndrome often have lower than normal testosterone levels and low~     testosterone levels have been suggested to predispose for development of type2 diabetes. The~     aim of the study is to evaluate if normalisation of serum testosterone levels in men with~     metabolic syndrome (Abdominal obesity, hypertension, dyslipidemia, insulin resistance and~     pre-diabetes or overt type diabetes)improves sensitivity to insulin and improves the signs of~     the metabolic syndrome~   "
235020|NCT00479596|"~     The current study will investigate the comparative efficacy, safety and patient satisfaction~     of intradetrusor injections BOTOX® injections (200U) versus placebo (saline) injections in~     the treatment of OAB secondary to benign prostatic obstruction (BPO).~   "
235021|NCT00479583|"~     The purpose of this research study is to determine the highest dose of BMS-690514 that can be~     safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to~     patients with advanced cancer~   "
235022|NCT00479570|"~     The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on~     acute sexual arousal and sexual interest in post menopausal females, as well as examining the~     safety and toleration of the drug.~   "
235023|NCT00479557|"~     To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active~     immunization, in patients with mild to moderate Alzheimer's disease.~   "
235024|NCT00479531|"~     The purpose of this study is to determine if sequential compression devices (SCD) when worn~     for an hour per day by patients suffering from Restless Legs Syndrome (RLS) are helpful for~     the improvement of the RLS symptoms and sleep.~   "
235025|NCT00479518|"~     Patients with stroke or transient ischemic attack (TIA) are at high risk of poor outcome,~     recurrence of cardiovascular events or vascular death.Until now, no reliable predictive~     biological marker could be identified in the acute phase of stroke.We hypothese that, in the~     acute phase of ischemic stroke or TIA, the increase of cardiac ( brain natriuretic peptide,~     BNP) or renal markers (albuminuria, cystatin C)might predict recurrence of cardiovascular~     events or vascular death. We want to assess which one of these markers has the best prognosis~     value , in a prospective study of 300 stroke patients followed during 3 years.~   "
235026|NCT00479505|"~     This is a 12 week study in which different doses of UK-369,003 will be administered to~     patients with a diagnosis of overactive bladder. Patients will complete a series of~     questionnaires before treatment, during treatment and after treatment, to assess whether~     UK-369,003 has improved their symptoms of overactive bladder and erectile function.~   "
235027|NCT00479492|"~     The purpose of this study is to determine whether CP-866,087 is effective in the weight loss~     of overweight patients.~   "
235028|NCT00479479|"~     Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in~     infants. We have earlier investigated cobalamin status in healthy children and we observed~     metabolic evidence of impaired cobalamin status during the first 6 months, but not later in~     life.~      The purpose of this study is to determine if cobalamin supplementation may influence the~     metabolic profile related to cobalamin status in infants.~   "
235029|NCT00479466|"~     A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes~     Mellitus).~   "
235030|NCT00479440|"~     To assess the safety and tolerability of ascending single oral doses of SAM-315, an~     investigational drug, in healthy adult subjects. To obtain a preliminary pharmacokinetic (PK)~     and pharmacodynamic (PD) profiles of SAM-315 in healthy subjects and to evaluate the effect~     of a high-fat meal on the PK of SAM-315, an investigation drug, administered to healthy adult~     subjects.~   "
235031|NCT00479427|"~     This is a double-blind, two-period, placebo controlled cross-over Phase IIa study. This study~     is to use CB2 compound of GW842166 in patients with osteoarthritis. The pain assessments and~     WOMAC questionnaires will be used in the study after the repeated dose to evaluate the~     efficacy of CB2 compound of GW842166.~   "
235032|NCT00479401|"~     The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to~     determine the efficacy (as measured by the change from baseline to the end of the maintenance~     phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II~     and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily~     doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority~     between the two formulations (ER and IR) of pramipexole.~      In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo,~     for assay sensitivity~   "
235033|NCT00479388|"~     This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed~     dyslipidemia to study the effects of ER niacin/laropiprant on lipids.~   "
235034|NCT00479375|"~     Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for~     detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of~     longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a~     protective effect.~      Methods: A total of 12527 women, aged 32-38, attending population-based invitational~     screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or~     cytology only (control arm). HPV-positive women were invited for a second HPV test at least~     one year later and women with type-specific persistent infections were then invited to~     colposcopy. A similar number of random double-blinded procedures are performed in the control~     arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the~     relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary~     outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes~     stratified by grade of CIN (CIN 2 or CIN3+).~   "
235035|NCT00479362|"~     There are no established guidelines regarding interruption of warfarin anticoagulant therapy~     prior to surgical implantation of cardiac pacemakers. Continuing the anticoagulant could~     potentially result in increased bleeding complications from the implantation surgery, whereas~     discontinuing the anticoagulant could predispose the patient to blood clots and strokes. In~     this study we intend to randomly assign warfarin-treated patients either into interrupted or~     continued warfarin therapy prior to pacemaker implantation with the purpose of establishing~     the rate of complication in these groups. Our hypothesis is that a cardiac pacing device can~     be safely implanted without discontinuation of the anticoagulant therapy.~   "
235873|NCT00468182|"~     The purpose of this study is to determine whether interferon-beta impairs the ability of~     plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple~     sclerosis.~   "
235037|NCT00479336|"~     To investigate the dose response for changes from baseline in body weight as a primary~     endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb~     edema, and pleural effusion as secondary endpoints in seven-day repeated oral administration~     of OPC-41061 at 7.5, 15, and 30 mg/day or placebo in cirrhosis patients with ascites despite~     taking conventional diuretics.~   "
235038|NCT00479323|"~     Serum 89 SF is a supply of serum that was collected from people who were vaccinated with the~     pneumococcal vaccine in the late 1980s. The supply of this serum is running low. The purpose~     of this study is to give the pneumococcal vaccine to healthy volunteers and take serum blood~     samples in order to increase the reference serum supply. Study participants will include 250~     healthy men and women, ages 18-45. Study procedures will include a physical exam, interviews,~     blood samples and blood testing. All volunteers will receive the pneumococcal vaccine in the~     deltoid muscle of the arm. Participants will be involved in the study for approximately 17~     weeks.~   "
235039|NCT00479310|"~     A Multi-center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the~     Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the treatment of~     Head Lice.~   "
235040|NCT00479297|"~     To assess the safety and tolerability of ascending single oral doses of SAM-531, an~     investigational drug, in healthy Japanese male subjects. Secondary: To obtain preliminary~     pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531 in healthy Japanese male~     subjects.~   "
235041|NCT00479284|"~     Patients with chronic hypercapnic respiratory failure can be successfully treated with home~     nocturnal non-invasive ventilation. Bi-level pressure support ventilators are at present the~     most frequently used ventilators for long term home ventilation. A recently commercialized~     bi-level ventilator offers the feature of automatically adjusting pressure support on the~     basis of a pre-determined ideal effective ventilation. Because this option may induce~     important swings in pressure support, and thus patient discomfort, and maybe increase leaks,~     we chose to analyse the impact of average volume assured pressure support (AVAPS) on patient~     comfort, subjective and objective quality of sleep and efficacy of ventilatory support.~   "
235042|NCT00479271|"~     The aim of this trial was to apply a home based, flexible, stepped-care intervention designed~     to improve the awareness and knowledge of family caregivers regarding dementia, to maximise~     their caregiving resources and to improve their caregiving skills. A Randomized Controlled~     Trial (RCT) will be used to evaluate the same wherein the intervention group will get the~     services immediately and the control arm would receive the same after a period of 6 months.~   "
235043|NCT00479258|"~     To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in~     subjects ages 6-17 over a 1 year period.~   "
235044|NCT00479245|"~     The main purpose of this study is to determine the measurement characteristics of WHODAS-II~     (World Health Organization Disability Assessment Schedule), as well as to analyze its~     correlation with low back pain (Visual Analog Scale, VAS), disability (Spanish version of the~     Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of~     the FAB Questionnaire, FABQ) and quality of life (SF-12). Measurements will be taken at~     baseline and 6 days later (day 7).~   "
235045|NCT00479232|"~     This study is to evaluate the safety and tolerability of vorinostat in combination with~     decitabine as well as the in vivo molecular and biological effects of vorinostat in patients~     with refractory or relapsed Acute Myelogenous Leukemia (AML) and intermediate or high risk as~     defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS).~     Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome are eligible.~   "
235046|NCT00479219|"~     To assess the pharmacodynamics (PD) of biomarkers amyloid beta peptide 40 and 42 (Ab40 and~     Ab42) in CSF, following single oral doses of GSI-953, an investigational drug, in healthy~     young subjects and patients with Alzheimer Disease (AD).~   "
235047|NCT00479206|"~     The principal aim of this project is to investigate reports of developing artemisinin~     resistance in Cambodia using an integrated in vivo - in vitro approach to examine recent~     alarming reports of treatment failures with advanced combination therapies along the~     Thai-Cambodian border, which could have major impact on the malaria situation in the affected~     areas as well as the rest of the malaria-endemic world.~   "
235048|NCT00479193|"~     Patients will be screened at the initial visit to the burn center. If the patients are~     eligible according to the inclusion/exclusion criteria, consent for the study will be~     obtained. One of the investigators will identify two sites that appear to be the same depth~     on each patient [1 site Polymen and 1 site bacitracin/xeroform )]. The depth of injury will~     be verified as partial thickness using laser doppler. Each site will be at least 4cm x 4cm in~     size. One site will be identified for bacitracin/xeroform and one site for Polymen. All burns~     will be initially debrided and cleaned according to burn unit protocol. The dressing will~     then be applied. All dressings will be covered with cotton gauze and ace wraps. Laser Doppler~     will be utilized to determine burn depth at both the trial and control sites. On each~     subsequent visit, patients will rate the pain of the dressing change on a 1-10 pain intensity~     scale. It will be noted if the wound appears infected or if antibiotics are prescribed.~      The study will end for each patient when the investigator determines that 95% of their burn~     has re-epithelized.~   "
235049|NCT00479180|"~     Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation~     of an AV graft or fistula for hemodialysis access.~   "
235050|NCT00479167|"~     The purpose of this study is to determine what dose of bortezomib in combination with~     tositumomab I-131 is tolerable whether bortezomib and Tositumomab I-131 are effective in the~     treatment of relapsed or refractory non-hodgkin's lymphoma (NHL). Both agents are effective~     in treating relapsed and refractory NHL. Administer of the agents together may sensitize the~     cells to the radiation from Tositumomab I-131.~   "
235103|NCT00478465|"~     The purpose of this study determine whether the drug valganciclovir has a significant and~     real benefit on the central core of symptoms experienced by patients who have high titers to~     EBV and HHV-6 and are experiencing long-standing fatigue and cognitive impairment (CFS).~      In addition, to characterize a quantifiable biological marker in these patients that will~     facilitate the identification of those likely to respond to valganciclovir and will make it~     possible to assess response to treatment.~   "
235051|NCT00479154|"~     This study will test whether botulinum toxin (Botox) may relieve the uncomfortable sensations~     patients with restless legs syndrome (RLS) experience. RLS is a common movement disorder that~     causes sensory discomfort and restlessness, most often in the legs, which improves with~     movement. Although medications are available to treat the disorder, many people experience~     side effects that prevent them from continuing on the medication. The Food and Drug~     Administration has approved Botox for other movement disorders and for some cosmetic uses.~      People 18 years of age or older with moderate to severe RLS who have been taking RLS~     medications for more than 6 weeks before entering the study may be eligible to participate.~     Candidates are screened with a medical history, physical and neurological examinations, blood~     tests and, for women who can become pregnant, a urine pregnancy test.~      Participants are randomly assigned to receive injections of either Botox or placebo (salt~     water) into up to nine areas of the legs. The correct location of the muscles to be injected~     is determined by electromyography (EMG), a test that measures the electrical activity of~     muscles. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and~     taped to the skin. Needle EMG involves inserting a needle into a muscle. Both methods are~     used in this study.~      At 2 and 4 weeks after the injections, subjects are interviewed by telephone and asked to~     describe their symptoms, side effects and any improvement they may have noticed. After 12~     weeks they return to NIH for injections with the alternate compound; that is, those who~     received Botox previously are given placebo for the second set of injections, and vice-versa.~     Subjects are again contacted by telephone 2 and 4 weeks after the injections to report their~     symptoms, side effects and benefits.~   "
235052|NCT00479141|"~     The HIV epidemic in China has reached a phase of exponential growth; the number of new~     infections has been steadily increasing over the past decade. The purpose of this study is to~     evaluate the effectiveness of a Combined Individual- and Community-Based Behavioral~     Intervention to Improve Quality of Life for HIV-Positive Villagers and decrease HIV related~     stigma in Rural China.~   "
235053|NCT00479128|"~     The goal of this clinical research study is to find the highest tolerable dose of Gemzar®~     (gemcitabine) and Adriamycin® (doxorubicin) that can be given together with Velcade®~     (bortezomib) in patients with urothelial cancer or other solid tumors.~   "
235054|NCT00479115|"~     The purpose of this research study is to determine whether an experimental drug called~     AMD3100 used in combination with another medication called G-CSF is safe and can help to~     increase the amount of blood stem cells (called CD34+ stem cells) found in the peripheral~     blood of patients with Fanconi anemia. While AMD3100 has been used successfully in adult~     volunteers and cancer patients, it has not been used in children or patients with Fanconi~     anemia and in only a few children with cancer.~      Fanconi anemia is a rare genetic disease. Most Fanconi anemia patients eventually develop~     bone marrow failure, a condition in which the bone marrow no longer produces red blood cells~     (to carry oxygen), white blood cells (to fight infection), and platelets (to help blood~     clot). The only successful treatment for patients with Fanconi anemia with bone marrow~     failure is bone marrow transplantation. However, this treatment has many risks and is not~     available to all patients with Fanconi anemia.~      CD34+ cells include stem cells found in the bone marrow or peripheral blood which are capable~     of making the red blood cells, white blood cells, and platelets. CD34+ stem cells can be~     collected from bone marrow or peripheral blood and purified using an experimental device~     called the CliniMACS. However, most Fanconi anemia patients do not have enough CD34+ stem~     cells in their bone marrow or peripheral blood to be collected using standard methods that~     work well in children and adults who don't have Fanconi anemia.~   "
235055|NCT00479102|"~     Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron~     deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive~     dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be~     followed up as a control group. Following a nutritional questionnair, parents of all babies~     will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up~     blood count will be taken from all participating babies 3 months after recruitment. The study~     aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The~     hypothesis is that babies who receive iron supplementation in the 2nd year of life are less~     likely to develop iron deficiency or anemia.~   "
235056|NCT00479089|"~     Primary Objective:~      1. To compare the proportion of patients free from progression 9 months from the start of~     consolidation therapy with the combination of docetaxel and ZD1839 (Iressa) versus docetaxel~     alone. For the purposes of this protocol, consolidation therapy refers to treatment given~     at the time of maximal benefit from conventional front-line multi-agent chemotherapy.~      Secondary Objective:~      1. To compare time to progression (TTP), overall survival (OS) and cause-specific survival~     (CSS) in the two arms. For completeness, these will be reported both from the initiation of~     consolidation chemotherapy, and from the completion of induction chemotherapy.~   "
235057|NCT00479076|"~     The primary objective of this study is to determine the recommended phase II dose of AVE0005~     in combination with S-1 in Japanese cancer patients.~      The secondary objectives of this study are to assess the safety profile of AVE0005, to~     determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor~     effects.~   "
235058|NCT00479063|"~     In this case-control study, cases were chronic LBP patients aged 30-50 in whom a lumbar MRI~     had been prescribed. Controls were subjects aged 30-50 in whom a cranial MRI had been~     prescribed for headache, who did not suffer from LBP and had no history of clinically~     relevant LBP. Two hundred and forty cases and 64 controls were recruited consecutively in~     Radiology services across six cities in Spain. Imaging findings and subjects' characteristics~     were gathered through previously validated instruments. Radiologists who interpreted MRIs~     were blinded to subjects' characteristics. A multivariate logistic regression model was~     developed to assess the association of Modic changes with LBP, adjusting for sex, age,~     body-mass index, lifetime exposure to smoking, physical activity, and disk degeneration.~   "
235059|NCT00479050|"~     Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma~     greater than 3 cm,the ablation volume of coagulation necrosis can be significantly~     increased,which may be enable effective treatment of patients with HCC greater than 3 cm.~   "
235060|NCT00479037|"~     The primary objective of this trial is to show that PTH(1-84) is superior to strontium~     ranelate in bone formation measured as changes in bone formation markers over a treatment~     period of 24 weeks in postmenopausal women with primary osteoporosis.~   "
235061|NCT00479024|"~     To determine comparative 1-year outcomes in renally impaired patients who previously~     underwent cardiac angiography with Isovue®-370 or Visipaque™ 320 as part of the IOP-104 trial~     protocol and were evaluable for determination of post-contrast significant renal injury~     (defined as >25% increase in SCr or >25% increase in cystatin C).~   "
235062|NCT00479011|"~     Hypovolaemia and tissue hypoperfusion can pass undetected during and after major surgery. The~     resulting systemic inflammatory response and organ dysfunction, often not clinically apparent~     for several days, may lead to increased morbidity and mortality and prolonged hospital stay.~      In this regard, intraoperative optimization of circulatory status by volume loading has been~     shown to improve the outcome of patients undergoing high-risk surgery.~      Indeed, several reports (1-7) have shown that monitoring and maximizing stroke volume by~     volume loading (until stroke volume reaches a plateau, actually the plateau of the~     Frank-Starling curve) during high-risk surgery decreases the incidence of post-operative~     complications and the length of hospital stay.~      Unfortunately, this strategy has required so far the measurement of stroke volume by a~     cardiac output monitor, as well as a specific training period for the operators (8), and~     hence is not applicable in many institutions as well as in many countries.~      The arterial pulse pressure variation (∆PP) induced by mechanical ventilation is known to be~     a very accurate predictor of fluid responsiveness, i.e. of the position on the preload/stroke~     volume relationship (Frank-Starling curve) (9).~      By increasing cardiac preload, volume loading induces a rightward shift on the preload/stroke~     volume relationship and hence a decrease in ∆PP. Patients who have reached the plateau of the~     Frank-Starling relationship can be identified as patients in whom ∆PP is low (9).~      Therefore, the clinical and intraoperative goal of “maximizing stroke volume by volume~     loading” can be achieved simply by minimizing ∆PP.~      We designed the present study to investigate whether monitoring and minimizing ∆PP by volume~     loading during high-risk surgery may improve post-operative outcome and decrease the duration~     of post-operative hospital stay.~   "
235063|NCT00478998|"~     The purpose of this study is to see whether patients undergoing ESWL, for upper tract urinary~     stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of~     inserting ureteral stents .~   "
235064|NCT00478985|"~     The first purpose of this study is to evaluate the persistence of the complete molecular~     remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment~     (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for~     bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors~     associated with the persistent complete molecular remission.~   "
235065|NCT00478972|"~     The primary objective of this study is to assess the efficacy of Rimonabant (SR141716)~     compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in~     obese type 2 diabetic patients inadequately controlled with diet and exercise alone.~      The secondary objectives are:~        -  To evaluate the effect of Rimonabant compared to placebo on other parameters related to~          the glucose control, waist circumference, Body Mass Index and metabolic parameters;~        -  To evaluate the safety and tolerability of Rimonabant compared to placebo;~        -  To evaluate the pharmacokinetics of Rimonabant.~   "
235066|NCT00478959|"~     This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in~     patients with relapsed or refractory Hodgkin's lymphoma.~   "
235067|NCT00478946|"~     Colorectal cancer is a type of cancer that begins in the large intestine (colon) or the~     rectum (end of the colon). Several drugs are often given in combination to treat colorectal~     cancer. One of the most active treatment combinations is known as FOLFOX, which is a~     combination of 5-fluorouracil (5-FU), leucovorin, and oxaliplatin. Oxaliplatin is a type of~     platinum drug and was approved by the FDA in 2004. While generally well-tolerated,~     oxaliplatin may cause toxicity to the nerves, such as sensory loss or cold sensitivity.~      Picoplatin is a new type of platinum drug that has shown activity with 5-FU in pre-clinical~     studies and has undergone extensive Phase 1 and Phase 2 testing in a variety of cancers. No~     significant nerve toxicity has been seen in previous studies of picoplatin.~      This study will review the safety and effectiveness of FOLPI, which is the combination of~     5-FU and leucovorin with picoplatin in participants with colorectal cancer.~   "
235068|NCT00478933|"~     To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify~     patients at risk of ventricular tachycardia.~      To evaluate the influence of ICD-based diagnostic information on the long term treatment and~     management of primary prevention ICD-patients.~   "
235069|NCT00478907|"~     This study was designed to investigate pre-operatively measured parameters of various~     anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil~     (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under~     tension as predictors of significant OCR in pediatric strabismus surgery.~   "
235070|NCT00478894|"~     In this study we will examine patients who have undergone unilateral ACL reconstruction~     surgery to determine which structural and functional characteristics of the knee two and ten~     years post reconstruction surgery, aspects of the original injury and repair, and patient~     characteristics are risk factors for osteoarthritis after ACL reconstruction surgery.~   "
235071|NCT00478881|"~     The purpose of this study is to assess if the study drug, Vardenafil (approved by Health~     Authorities is available on the market for treatment of erectile dysfunction) has an effect~     on bladder function and micturition frequency. The study drug is to be taken in the form of~     tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active~     treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug~     works better than no drug. The timing of visits for the study is as follows: the 1st visit~     (screening visit) at beginning of run-in-assessment with qualifying tests for patients:~     electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a~     non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit~     (randomization visit). During visit this should be performed: urodynamic measurements~     (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit~     (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final~     visit)-following test should be done: urodynamic measurements (filling cystometry and~     pressure flow investigations), ECG, safety laboratory and residual urine (by~     ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.~   "
235072|NCT00478868|"~     To assess: a) The prevalence of Modic changes and other findings on lumbar magnetic resonance~     imaging (MRI), among Spanish adult chronic LBP patients, b) Patient characteristics and~     radiological findings associated with Modic changes.~   "
235073|NCT00478855|"~     1. To determine the value of using piperacillin/tazobactam in reducing the cases of~          extended spectrum beta lactamases (ESBL) producing E. coli or K. pneumoniae colonization~          and infection.~        2. To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both~          pre-and post-intervention in the selected medical centers.~   "
235074|NCT00478842|"~     The aim of this study is to evaluate the efficacy and safety of bilateral pallidal~     stimulation in patients with a severe form of Gilles de la Tourette syndrome.~   "
235787|NCT00469313|"~     Hypothesis:benefits of inspiratory muscle strenght training with Respifit S decreases~     symptoms, disability or handicap of patients affected by COPD. The inspiratory fraction~     (inspiratory capacity IC/ total lung capacity TLC)may be functionally more representative~     than other traditional indices.~   "
235075|NCT00478829|"~     Objectives: Primary: To estimate the prevalence of depression and/or anxiety disorder in~     outpatients attending the general health care settings in China.~      Secondary:~        -  To estimate gender- and age-specific prevalence of depression and/or anxiety disorder in~          outpatients attending the general health care settings in China.~        -  To estimate the prevalence of depression and/or anxiety disorder in outpatients~          attending the general health care settings such as departments of neurology,~          gastroenterology, cardiology, and gynecology.~        -  To describe the recognition and treatment rate by treating physicians as depression~          and/or anxiety for outpatients in the general health care settings in China.~   "
235076|NCT00478816|"~     Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population~     (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects~   "
235077|NCT00478803|"~     The primary objective of the CAVIAAR study is to prove that aortic valve sparing for patients~     with aortic root aneurysms and/or dystrophic aortic insufficiency is associated with a 45%~     increase of 3 years-survival rate without increased mortality or serious increased morbidity~     events when compared to mechanical valve replacement.~      The main hypothesis of this study is that a standardized procedure of valve sparing based on~     external aortic annuloplasty in patients with dystrophic aortic insufficiency and/or aortic~     root aneurysm increases survival rate without increased mortality or serious increased~     morbidity events when compared with patients undergoing mechanical aortic valve replacement.~   "
235078|NCT00478790|"~     The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix are~     effective and safe to implant as an aid of glaucoma surgery and pterygium excision surgery.~   "
235079|NCT00478777|"~     This was a multicenter, open-label, single-arm phase 3B study of the combination lenalidomide~     plus pulse high-dose dexamethasone.~      This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program~     in Germany.~      Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (baseline) with~     the exception of hematology assessments that were to be performed within 14 days prior to~     Cycle 1 Day 1. Randomization, blinding, and stratification were not applied in this~     open-label single-arm study.~      Eligible subjects given open-label treatment and received treatment with lenalidomide plus~     high-dose dexamethasone in 28-day cycles.~      Lenalidomide (hard capsules) was to be administered orally (PO) at a dose of 25 mg daily (QD)~     for the first 21 days of each 28-day cycle. According to the protocol, accrual of subjects to~     the study was to be terminated within 2 months of commercial availability of lenalidomide for~     this indication in Germany.~      Upon discontinuation from study, minimal information was collected in order to identify when~     disease progressed.~   "
235080|NCT00478764|"~     The use of one dose of an antibiotic and steroid injected into the eye at the end of cataract~     surgery is as safe and effective as the post operative use of eyedrops after cataract~     surgery.~   "
235081|NCT00478751|"~     -  Determine the impact and the threshold of long wavelength UVA and visible light on~          immediate and delayed pigment production of melanocompetent individuals.~        -  The study basically wants to understand what types of light make us tan.~   "
235082|NCT00478738|"~     GSK961081 has previously been administered to healthy subjects in a nebulised formulation and~     the first part of this study which will be conducted in healthy subjects proposes to bridge~     the change from nebulised to DPI formulation of GSK961081 before administration to patients.~     The second part of the study will be conducted in COPD patients and aims to assess the safety~     and bronchodilator profile of GSK961081 over 24 hours, during 14 days dosing.~   "
235083|NCT00478725|"~     To study the absorption, distribution, metabolism and excretion of GW786034, and the~     absorption of a single IV dose of GW786034~   "
235084|NCT00478712|"~     Hirschsprung disease is a genetic condition caused by lack of nerve cells in varying lengths~     of the intestines. This study will investigate the complex genetic basis of the disease,~     which involves multiple interacting genetic factors.~   "
235085|NCT00478699|"~     Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely~     Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.~   "
235086|NCT00478686|"~     The goal of this laboratory research study is to identify possible differences in a gene~     among patients with breast cancer that cannot be treated by surgery. Researchers want to find~     out if differences in this gene may increase the risk of side effects from capecitabine.~   "
235087|NCT00478673|"~     The primary objective of the SONOMA Registry is to confirm the safety of the NexStent®~     Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical~     practice and to identify rare or unanticipated device-related events that might occur.~   "
235088|NCT00478660|"~     Due to the rigor of the clinical development program of adalimumab for the indication of AS,~     the population of subjects with active AS that could enroll in previous phase 3 studies was~     limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting~     that mimics day-to-day clinical practice to obtain further safety and efficacy data by~     allowing subjects meeting the characteristics noted below to enter this study:~        -  Subjects who failed another TNF inhibitor (etanercept, infliximab)~        -  Subjects with advanced spinal ankylosis~        -  Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)~   "
235089|NCT00478647|"~     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme~     glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside~     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ~     system dysfunction. The purpose of this study is to evaluate the safety and efficacy of every~     other week dosing of GA-GCB (velaglucerase alfa) in participants with type 1 Gaucher disease~     who were previously treated with imiglucerase.~   "
235090|NCT00478634|"~     This study will assess the safety of RAD001 when given together with cetuximab and irinotecan~   "
235104|NCT00478452|"~     This is a randomized Phase I/II study designed to assess the induction of an anti-tumor~     immune response; the effect of cyclophosphamide on the vaccine; and to assess safety in~     subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent~     DC vaccine, with or without a single dose of cyclophosphamide.~      Potential benefit may range from no direct benefit to the study participants to stimulation~     of the subject's own immune system to attack ovarian cancer to prevent relapse.~   "
235091|NCT00478621|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the~     uterus or womb). This infection may go away by itself, but if it does not go away (this is~     called persistent infection), it can lead in women over a long period of time to cancer of~     the cervix. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic~     types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also~     evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals'~     HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control~     vaccine. There will be different levels of blinding in the study.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
235092|NCT00478608|"~     Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed~     acute rejection episode at 6 months after transplantation in Korean renal transplantation~     recipients.~      Secondary :~        1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal~          transplantation recipients.~        2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after~          transplantation, and to investigate the incidence of biopsy-confirmed acute rejection~          episode at 12 months after transplantation.~   "
235093|NCT00478595|"~     The primary objective of this study is to assess the efficacy of Rimonabant (SR141716)~     compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in~     obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic~     drug (sulfonylurea or α-glucosidase inhibitor).~      The secondary objectives are:~        -  To evaluate the effect of Rimonabant compared to placebo on other parameters related to~          the glucose control, waist circumference, Body Mass Index and metabolic parameters;~        -  To evaluate the safety and tolerability of Rimonabant compared to placebo;~        -  To evaluate the pharmacokinetics of Rimonabant.~   "
235094|NCT00478582|"~     The clinical evaluation of anemia is usually done by examination of the palpebral conjontivae~     coloration. This appreciation remains crude and largely observer dependent, as no reference~     scale was successfully proposed,. A Hb visual scale allowing the assessment of the degree of~     clinical anemia has been developed. Its use has been validated so far in small patient groups~     in the following settings: blood donation, cardiac surgery, oncology and consultation of~     general practitioners.~      The objective of the present investigation is to validate the use of a Hb visual scale for~     the clinical evaluation of anemia in patients with kidney disease patients~   "
235095|NCT00478569|"~     The primary objective is:~      1) to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment~     when prescribed in a normal clinical setting.~      The secondary objectives are:~        1. to describe the demographics and clinical characteristics of the patients that in a~          normal clinical setting are started on a treatment regimen with PTH(1-84)~        2. to describe (using available data) the long term treatment effectiveness during the 24~          months following initiation of PTH(1-84) treatment in a normal clinical setting~        3. to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient~          in a normal clinical setting.~   "
235096|NCT00478556|"~     Patients who are scheduled by their health care provider for routine computed tomography (CT)~     scan will be asked to participate in this study. The primary purpose is to determine if there~     is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for~     abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference~     in bowel opacification for the two agents.~   "
235097|NCT00478543|"~     The purpose of this study is to verify the efficacy of diuretic therapy on blood pressure~     control and left ventricular mass in patients affected by chronic kidney disease~   "
235098|NCT00478530|"~     To evaluate the scotopic and photopic ERG responses before and after one month of~     intravitreal avastin injection in patients with choroidal neovascularization.~      A positive finding that will reveal a toxic effect of intravitreal avastin injection on any~     component of the retina will have a significant important clinical impact regarding the~     decision whether the benefit of avastin treatment for CNV will prevail over toxic effect.~   "
235099|NCT00478517|"~     The social, psychological, economic burden of Spinal trauma with deficit is great, and there~     is no curative treatment.~      Erythropoetin (EPO) is promising, due to its neuroprotective effects demonstrated in vitro,~     in vivo in animal models and in a preliminary study including patients with stroke.~      The study primary end point is to find out the maximum tolerated dose of EPO. This is based~     on the occurrence of pulmonary embolism during a 14 day delay following EPO injection.~     Secondary end points include comparisons of EPO kinetics in blood and cerebrospinal fluid~     (CSF), study of EPO effects on several inflammatory and apoptotic bio markers and blood cell~     counts.~      The experimental design is a dose scale study (600 to 2400 UI/Kg), using a single dose of~     rHuEPO, (EPREX®). The EPO dose is defined using a Bayesian continuous reassessment Method~     (CRM). The sample size is expected for less than 20 patients.~      Eligible patients are patients aged 15 to 65 years, able to receive the EPO injection within~     12 hours of a spinal trauma, without vital blood loss or associated diseases. The follow-up~     lasts 6 months.~   "
235100|NCT00478504|"~     The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction~     agent and to test the hypothesis that letrozole will generate better pregnancy rates with~     fewer multiple pregnancies and higher live birth rate than the current standard agent,~     clomifene citrate in anovular infertile women with polycystic ovarian syndrome.~   "
235101|NCT00478491|"~     The purpose of this study is to investigate the organization of memory and develop future~     methods for early detection of AD. Using functional magnetic resonance imaging (fMRI), we~     examine the responsiveness of the brain to memory tasks, specifically focusing on regions of~     the brain (the mesial temporal lobe and posterior cingulate) that are known to be involved in~     early stages of Alzheimer's disease (AD). Of interest are differences in brain activation~     between people with and without a family history of AD and other risk factors.~   "
235102|NCT00478478|"~     Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will~     include:~        -  Post-procedure revascularization success~        -  90-day mRS 0-2~        -  90-day mortality~   "
235123|NCT00478192|"~     The study is designed to assess the efficacy and safety of multiple infusions of conivaptan~     in subjects with euvolemic or hypervolemic hyponatremia~   "
235105|NCT00478439|"~     The study will evaluate whether taking a nutritional supplement designed to increase macular~     pigment in the eye can improve a person's ability to adjust to darkness. Patients will be~     assigned to take either a placebo or nutritional supplement for 8 months. Vision will be~     assessed at baseline, 4 months, and 8 months.~   "
235106|NCT00478426|"~     This phase II trial studies how well sunitinib malate works in treating patients with~     endometrial cancer that has come back after a period of improvement (recurrent) or has spread~     to other places in the body (metastatic). Sunitinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
235107|NCT00478400|"~     This study will use MRI imaging, cognitive testing and outcome questionnaires to determine~     how the brain recovers and reorganizes after an injury.~   "
235108|NCT00478387|"~     The purpose of this study is to determine what the immune response is of ovarian cancer~     patients in remission, when they are given the flu vaccine. After receiving the flu vaccine,~     patients will have blood drawn 5 times in 12 months to study antibody response to the flu~     vaccine.~   "
235109|NCT00478374|"~     The purpose of this study is to determine the feasibility to combine sorafenib with~     transarterial chemoembolisation in patients suffering from hepatocellular carcinoma.The~     hypothesis is that sorafenib may prevent the development and growth of tumoral lesions not~     treated by chemoembolisation.~   "
235110|NCT00478361|"~     This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin~     together with pegfilgrastim works in treating patients with metastatic or unresectable~     bladder cancer or urinary tract cancer and kidney dysfunction. Drugs used in chemotherapy,~     such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Colony~     stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in~     bone marrow or peripheral blood and may help the immune system recover from the side effects~     of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more~     tumor cells. Chemotherapy drugs may have different effects in patients who have changes in~     their kidney function.~   "
235111|NCT00478348|"~     The purpose of this study is to determine whether drainage after prosthetic repair of~     incisional abdominal hernias increases or decreases complications such as infection, seromas~     and hematomas.~   "
235112|NCT00478335|"~     The purpose of this research study is to determine if two investigational medications will be~     more effective in decreasing urine output than the currently available and routinely used~     medications in patients with congenital nephrogenic diabetes insipidus (NDI).~   "
235113|NCT00478322|"~     Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and~     tolerability as well as the effects of treatment with an investigational drug.~   "
235114|NCT00478309|"~     RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than~     usual care in increasing the number of healthy participants who regularly receive screening~     for colorectal cancer.~      PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk~     Assessment program to see how well it works compared with usual care to increase colorectal~     cancer screening in healthy participants.~   "
235115|NCT00478296|"~     Evidence has shown poor outcome for adult patients with pre-operative pulmonary hypertension~     following closure of an atrial septal defect. Life-threatening pulmonary hypertensive crises~     may occur in these patients when they no longer have an atrial communication to decompress~     high right heart pressures. This concern has led some to advocate fenestrated patch closure~     of ASDs in patients with pulmonary hypertension with the prospect of a repeated procedure in~     order to close the fenestrations at a later date.~   "
235116|NCT00478283|"~     RATIONALE: A patient's age, health, and ability to perform daily activities may affect which~     treatment options are offered by doctors to older and/or frail women with breast cancer.~      PURPOSE: This clinical trial is studying the views and attitudes of oncologists and~     geriatricians on the use of chemotherapy and hormone therapy in treating older and/or frail~     women with breast cancer.~   "
235117|NCT00478270|"~     This single arm study will assess the efficacy of loading doses of intravenous Bondronat in~     reducing pain in patients with breast cancer and metastatic bone disease experiencing~     moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat~     on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target~     sample size is <100 individuals.~   "
235118|NCT00478257|"~     Patients treated with chemotherapy complain of poor sleep, fatigue and depression. In~     addition, chemotherapy disrupts the body's internal biological clock, which may make sleep,~     fatigue and depression all worse. Women with breast cancer undergoing chemotherapy are not~     exposed to much bright light and this may also contribute to the disruption of their body~     clock, because bright light is necessary for a strong biological clock. One of the easiest~     ways to strengthen the biological clock is by increasing bright light exposure. The correct~     timing of the light exposure will help the women feel more alert during the day.~   "
235119|NCT00478244|"~     RATIONALE: In animal models, stem cells have been shown to home to the skin and repair the~     biochemical and structural abnormalities associated with recessive dystrophic epidermolysis~     bullosa (RDEB) (collagen 7 deficiency).~      PURPOSE: To determine the safety and effectiveness of stem cell infusion in the treatment of~     RDEB.~   "
235120|NCT00478231|"~     To collect safety and tolerability data in a more diverse patient population of patients with~     HIV/Aids, who have limited therapeutic options.~   "
235121|NCT00478218|"~     RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the~     cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may~     kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving~     lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with~     newly diagnosed multiple myeloma.~   "
235122|NCT00478205|"~     The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the~     currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with~     moderate to severe Alzheimer's disease.~   "
235124|NCT00478179|"~     Neuropathic pain is caused by a virus commonly associated with chicken pox. This virus may~     become dormant in the nervous system and later reactivate causing herpes zoster, also known~     as shingles. Post-herpetic neuralgia (PHN) is a persistent pain in the area of healed skin~     lesions. This study will test the safety and efficacy of treating PHN patients with the~     analgesic patch, Bupivacaine TTS (Eladur™).~   "
235125|NCT00478166|"~     The purpose of this study is to use fMRI techniques to explore a certain part of the brain~     associated with Alzheimer's disease known as the posterior cingulate. Determining the~     functionality of this brain region may help us diagnose AD more accurately, thus allowing~     earlier treatment.~   "
235126|NCT00478140|"~     This phase II trial is studying how well trastuzumab works in treating patients with locally~     advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by~     surgery. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them~   "
235127|NCT00478127|"~     In this study, we tested the hypothesis that elevated HGF is associated with insulin~     resistance and cardiovascular autonomic dysfunction in type 2 diabetic patients not receiving~     insulin treatment.~   "
235128|NCT00478114|"~     This is the early access programme (EAP) of sorafenib in the indication of advanced renal~     cell carcinoma (RCC). The study is to evaluate the efficacy and safety of sorafenib in~     patients with advanced RCC.~   "
235129|NCT00478101|"~     For cancer patients with inadequate pain relief, a switch to an alternative opioid is the~     preferred option for symptomatic improvement. However, multiple opioids are often~     simultaneously administered for anecdotal reasons.~      The present study isdesigned to assess the analgesic profiles of two different strategies in~     chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the~     combination of oral oxycodone and transdermal fentanyl.~   "
235130|NCT00478088|"~     The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared~     to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical~     disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up~     period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2)~     revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement~     in neurologic status.~   "
235131|NCT00478075|"~     RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry~     radiation directly to cancer cells and not harm normal cells. Bortezomib may stop the growth~     of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the cancer. Bortezomib may also make cancer cells more sensitive to radiation~     therapy. Giving samarium Sm 153 lexidronam pentasodium together with bortezomib may kill more~     cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when~     given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in~     treating patients with relapsed or refractory multiple myeloma.~   "
235132|NCT00478062|"~     RATIONALE: Vaccines made from a tumor antigen may help the body build an effective immune~     response to kill tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and how well vaccine therapy~     works in treating patients who have received first-line therapy for Hodgkin's lymphoma.~   "
235133|NCT00478049|"~     This is a randomized, open-label, parallel group, phase III, multicenter, regional study. The~     total number of patients expected to be exposed to study procedures is approximately 150~     patients will be recruited by investigational sites throughout the Asia Pacific region that~     have expertise in treating patients with NSCLC.~   "
235134|NCT00478036|"~     The Investigators will compare, in a randomized, prospective, masked and controlled fashion~     the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred~     Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure~     (IOP) lowering and degree of ocular inflammation following selective laser trabeculoplasty~     treatment for open angle glaucoma.~   "
235135|NCT00478023|"~     The main objective of this study is to demonstrate the efficacy and safety of multiple-dose~     application of three different oral doses of CG5503 IR (tapentadol immediate release)~     compared to placebo in women undergoing abdominal hysterectomy.~   "
235136|NCT00478010|"~     RATIONALE: Determining how patients makes decisions about participating in a clinical trial~     may help doctors plan clinical trials in which more patients are willing to participate and~     are satisfied with their decision to participate.~      PURPOSE: This clinical trial is studying how patients with stage II, stage III, or stage IV~     pancreatic cancer or stage III or stage IV colon cancer or rectal cancer make decisions about~     participating in a clinical trial.~   "
235137|NCT00477997|"~     The purpose of this study is to examine the effects of a physiological bolus of growth~     hormone on insulin signaling pathways in muscle tissue in healthy lean men.~   "
235138|NCT00477984|"~     Previous studies have shown that alcohol significantly impairs driving performance. Acute~     alcohol administration also has a detrimental effect on secondary task performance during~     dual-tasks. The present study will investigate the effects of five different dosages of~     ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering~     performance and brain activity will be recorded in both single- and dual-task conditions.~   "
235139|NCT00477971|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different~     ways to stop the growth of plasma cells, either by killing the cells or by stopping them from~     dividing. Having an autologous stem cell transplant to replace the blood-forming cells~     destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more~     plasma cells are killed. By reducing the number of plasma cells, the disease may progress~     more slowly. It is not yet known whether combination chemotherapy is more effective than~     chemotherapy followed by an autologous stem cell transplant in treating primary systemic~     amyloidosis.~      PURPOSE: This randomized phase III trial is studying the side effects and how well giving~     low-dose melphalan together with dexamethasone works compared with high-dose melphalan~     followed by an autologous stem cell transplant in treating patients with primary systemic~     amyloidosis.~   "
235874|NCT00468169|"~     The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®)~     added to two concurrent chemoradiotherapy platforms of different intensity in locally~     advanced head and neck cancer.~   "
235141|NCT00477945|"~     This is a phase I trial to determine the maximum tolerated dose (MTD) of clofarabine in a~     combination with high-dose etoposide and cyclophosphamide. This is an initial step in~     developing a novel myeloablative preparative regimen for autologous hematopoietic stem cell~     transplantation (ASCT). While this phase I trial will initially develop the regimen in~     patients with refractory disease, it is expected that it will find its best application in~     patients with less advanced disease.~   "
235142|NCT00477932|"~     This study will collect blood, urine, and other tissue samples from 50 patients study-wide~     with Pentalogy of Cantrell and other inherited diseases that involve mutations in non-muscle~     genes. Mutations in non-muscle genes have been shown to result in human defects involving~     blood platelets, kidney, hearing and sight. The major objective of this protocol is to study~     a variety of blood, tissue and urine samples by looking at protein, DNA, and RNA in those~     collected samples.~   "
235143|NCT00477919|"~     RATIONALE: A hand held electronic tool used to monitor symptoms and assess quality of life~     may improve communication between patients and their doctors and improve the ability to plan~     treatment for patients with advanced cancer receiving palliative care. It is not yet known~     whether symptoms are better controlled with or without use of this electronic tool.~      PURPOSE: This randomized phase III trial is studying an electronic tool to see how well it~     records cancer symptoms in patients with advanced cancer receiving palliative care.~   "
235144|NCT00477906|"~     Previous studies suggests that M-Vax, a melanoma vaccine prepared from patients own cancer~     cells, can stimulated patients' immune system to react against their cancer. AVAX has~     identified a dose and schedule of administration of M-Vax that work optimally. In this study,~     AVAX will determine whether M-Vax is effective in shrinkage of melanomas that have spread~     (stage IV). To increase it effectiveness, M-Vax administration will be followed by~     administration of low doses of interleukin-2 (IL2), a marketed drug that is known to~     stimulate immunity and cause some shrinkage of melanomas. Two-thirds of patients will receive~     M-Vax + IL2, and one-third will receive a placebo vaccine + IL2. The study is blinded so that~     neither the patients nor their physicians know which material they are receiving.~      To be eligible for this study, patients must have at least one melanoma tumor that can be~     surgically removed and made into a vaccine. In addition, they must have melanoma that has~     spread to to the lungs or to soft tissue sites (under the skin, on the surface of the skin,~     lymph nodes). Eligible patients may have previously received one treatment (for example,~     chemotherapy) for their melanoma.~      Side effects of M-Vax are expected to be mild; the most common is the development of sore~     pimples at the site of vaccine injections. The low dose IL2 may cause some fatigue and other~     mild symptoms.~      It is expected that 387 patients will be treated in this study.~   "
235145|NCT00477893|"~     Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years~     from symptom onset), because the available clinical, biochemical and radiological methods are~     not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of~     SpA, and current data indicate a higher efficacy than previously available therapies. The~     improved treatment options have increased the need for improved methods for diagnosis,~     monitoring and prognostication of these diseases, so that the efficient therapies can be~     initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI)~     and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.~   "
235146|NCT00477880|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them.~      PURPOSE: This clinical trial is studying how well cetuximab works in treating patients with~     Ménétrier disease at high risk of developing stomach cancer.~   "
235147|NCT00477867|"~     RATIONALE: Gathering information about patients with ovarian cancer over time may help~     doctors learn more about a patient's use of medical services and the cost of these services.~      PURPOSE: This clinical trial is collecting information about the patient's health and use of~     medical resources over time in patients with stage III ovarian cancer receiving paclitaxel~     and cisplatin on clinical trial GOG-172.~   "
235148|NCT00477854|"~     The purpose of this study is to test the effects of chromium picolinate on food intake, food~     cravings, eating attitudes, and appetite. If chromium picolinate is found to have a~     beneficial impact on satiety and food intake, then this supplement may be an alternative or~     adjunctive treatment for overweight people desiring to modify their food intake. The primary~     hypothesis of this study is that among individuals who report being carbohydrate cravers,~     chromium picolinate supplementation will reduce food intake during a test lunch meal and~     produce greater satiety in comparison to a placebo.~   "
235149|NCT00477841|"~     To determine the response to treatment with a novel esophageal stent loaded with 125I seeds~     for intraluminal brachytherapy versus a conventional covered stent in patients with advanced~     esophageal cancer.~   "
235150|NCT00477828|"~     The purpose of this study is to determine whether treating sleep apnea with continuous~     positive airway pressure would result in improvements in cognition in patients with~     Alzheimer's disease.~   "
235151|NCT00477815|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal~     antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry~     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy,~     such as melphalan, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. A peripheral stem cell transplant using~     stem cells from the patient may be able to replace blood-forming cells that were destroyed by~     chemotherapy. Giving monoclonal antibody therapy together with chemotherapy and autologous~     peripheral stem cell transplant may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90~     ibritumomab tiuxetan when given together with rituximab, melphalan, and autologous peripheral~     stem cell transplant in treating patients with previously treated multiple myeloma.~   "
235211|NCT00477009|"~     The purpose of this study is to evaluate effects from a mandibular repositioning appliance on~     obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and~     cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea~     syndrome and in patients with symptomatic snoring.~   "
235152|NCT00477802|"~     The primary objective of this study is to determine whether intramuscular injections of~     botulinum toxin type A (Botox®) in selected cervical muscles at antidystonic dosages can~     reduce levodopa-induced peak-dose dyskinesias (LID) in the cervical region in adult patients~     with idiopathic Parkinson's disease. It is hypothesized that the intramuscular injection of~     antidystonic doses of botulinum toxin into cervical muscles will decrease the duration and~     severity of LID in the cervical region in patients with Parkinson's disease (PD).~   "
235153|NCT00477789|"~     In patients with chronic heart failure (CHF)due to dilated cardiomyopathy diastolic~     dysfunction occurs frequently and is related to a poor outcome. We have previously shown that~     parameters of diastolic function significantly correlate with uric acid levels, a marker of~     impaired oxidative metabolism. We aimed to determine whether inhibition of xanthine oxidase~     with allopurinol might affect diastolic function in patients with CHF.~   "
235154|NCT00477776|"~     Early use of oral maxalon can hasten and improve the establishment of breastfeeding in~     diabetic mothers after preterm and term deliveries.~      Maxolon promotes breastfeeding by working on the central nervous system which increases the~     milk producing hormone, prolactin which in turn helps to increase the milk supply for~     breastfeeding. Successful early breastfeeding establishment is important for continued~     breastfeeding.~   "
235155|NCT00477763|"~     To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who~     receive Restasis in 1 eye and vehicle (Endura) in the other eye.~   "
235156|NCT00477750|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and~     lenalidomide when given together with prednisone and to see how well they work in treating~     patients with newly diagnosed multiple myeloma.~   "
235157|NCT00477737|"~     In vitro studies and in vivo animal experiments have shown that halogenated volatile~     anesthetics have a protective effect on the ischemic myocardium. In clinical settings~     however, anesthetic preconditioning may be of more interest. The aim of our study was to~     evaluate the cardioprotective effect of sevoflurane in patients undergoing off-pump coronary~     artery bypass surgery. We proposed that a cardioprotective effect of sevoflurane would save~     myocardial function, which we measured acceleration by esophageal Doppler and cardiac index~     with bolus thermodilution methods, both during brief ischemia and reperfusion.~   "
235158|NCT00477724|"~     Severe CTEPH leads to an impaired physical capacity and a restricted quality of life and poor~     prognosis.~      Pulmonary endarterectomy represents the best choice as therapy, when the thrombi are located~     in the central pulmonary vessels and therefore can be operated. By this operation the~     pulmonary artery pressure can be normalised and the patients' survival improved. Up to now,~     after successful endarterectomy patients only receive anticoagulation.~      Despite operation many patients remain symptomatic and are restricted in their physical~     capacity. Therefore a hypothesis of this project is that most of the patients, even after~     successful operation, show peripheral vascular remodelling with a ventilation-perfusion~     mismatch and elevated pulmonary pressure during exercise.~      In this study we aim to analyse how many patients with CTEPH after endarterectomy show~     elevated pulmonary artery pressures at rest or during exercise and are limited in their~     physical capacity, hemodynamics, oxygen uptake and quality of life and need further therapy.~      Another aim is to examine whether exercise and respiratory therapy may improve the patients~     postoperatively.~      Therefore 30 patients with CTEPH > six months after endarterectomy, with ongoing restricted~     exercise capacity shall be included. After baseline examination in the University hospital~     Heidelberg the patients receive exercise and respiratory therapy for three weeks. The~     patients will receive further examinations at the end of rehabilitation after 3 weeks and~     after 15 weeks. All examinations include medical history, family history, physical~     examination, ECG and echocardiography at rest and during exercise, cardiopulmonary exercise~     testing, assessment of the respiratory muscle strength, the SF-36 questionnaire for quality~     of life, laboratory testing and MRI.~      Rehabilitation will be conducted in the clinic for rehabilitation Koenigstuhl, Heidelberg.~     Participants will be randomised into two groups, a control group receiving a conventional~     therapy for three weeks, in which physical exertion is to be avoided and a training group~     with additional exercise and respiratory therapy.~   "
235159|NCT00477711|"~     The purpose of this study is to investigate whether cetuximab (Erbitux®) with cisplatin and~     capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective.~   "
235160|NCT00477685|"~     1. . Study Objective: The objective of this study is to determine the safety and~          effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in~          phacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the~          reduction of Intraocular Pressure, and the secondary endpoint is to prove the safety via~          the incidence of complications and adverse events.~        2. . Study Design: The study is designed as a historical controlled study. Patient who meet~          the inclusion/exclusion criteria and sign the informed consent form will be included for~          this study. The allocation of subjects is non-randomized, and there is a single group~          for assignment.~        3. . Follow-Up: This investigation is including 7 post-operative visits and follow-up~          within 6 months from the date of surgery. Patients should be seen at postoperative days~          1, 7, 14, 30, 60, 90 and 180. The visit window of ± 7 days is allowed for the 30, 60, 90~          and 180 day visits. The further follow-up of subject after trial is continually tracked~          by the investigator.~   "
235161|NCT00477672|"~     This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103)~     compared to placebo in patients with Parkinson's disease psychosis.~   "
235162|NCT00477659|"~     The objective of this study is to identify neural correlates of cognitive improvement after~     three months of donepezil HCl in subjects with mild Alzheimer's Disease (AD), measuring the~     Functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion in~     the Medial Temporal Lobe network. The hypothesis is that donepezil HCl will improve MTL~     connectivity and CBF Perfusion in the MTL-projected target regions, which will significantly~     correlate with cognitive improvement in mild AD subjects.~   "
235163|NCT00477646|"~     RATIONALE: Women may stay up-to-date with cancer screening if a health professional helps~     them overcome barriers to screening, including helping them to schedule cancer screening~     appointments.~      PURPOSE: This randomized clinical trial is studying the use of health professional-tailored~     telephone support compared with usual care from their personal doctor to help women overcome~     barriers to screening for colorectal, cervical, and breast cancer.~   "
235164|NCT00477633|"~     This is a non-comparative study. the primary objective of the study is to assess the efficacy~     of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are~     to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of~     the product.~   "
235875|NCT00468156|"~     The main aim of this study is to determine if persons can increase fruit and vegetable~     intakes if they make a specific plan to do so.~   "
235165|NCT00477620|"~     Purpose:~      To determine whether the use of reading glasses blocks the near work mediated increased~     incidence of myopia in healthy school children.~      Methods:~      SMART enrolled 115 emmetropic children (ages 7-9 years). The children were recruited in the~     Principality of Liechtenstein. They were randomly assigned to either the control group (n=52)~     or to receive reading glasses with a lens power of +2.0 dioptres (n=63). The primary outcome~     measure was progression towards myopia as determined by autorefraction after cycloplegia. The~     secondary outcome measure was change in biometry measurements of corneal curvature, axial~     length, anterior chamber depth, crystalline lens thickness, and vitreous chamber depth using~     partial coherence interferometry.~   "
235166|NCT00477607|"~     RATIONALE: Alpha-lipoic acid may prevent or lessen hearing loss caused by cisplatin.~      PURPOSE: This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in~     preventing hearing loss in cancer patients undergoing treatment with cisplatin.~   "
235167|NCT00477594|"~     The purpose of this study is to evaluate the safety and efficacy of extended dosing of~     mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have~     completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) clinical drug~     trials.~   "
235168|NCT00477581|"~     This purpose of this study is to compare the effect of exenatide to that of sitagliptin on~     2-hour postprandial glucose in subjects with type 2 diabetes mellitus.~   "
235169|NCT00477568|"~     The primary purpose of this study is to determine the prevalence of back pain in permanent~     wheelchair users (excludes transitory users) in different regions of Spain. Another study~     objective is the identification of risk factors for back pain in this population. Data~     collection will be by means of a structured questionnaire which will be validated in a~     previous pilot study.~   "
235170|NCT00477555|"~     The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows~     valves to maintain their natural leaflet structure and root geometry which prevents leaflet~     calcification and improves hemodynamic performance and a potential for increased durability.~     This study will document the hemodynamic performance, as assessed by echocardiographic~     recordings, at six months post implantation.~   "
235171|NCT00477542|"~     This is a phase trial to determine the maximum tolerated dose (MTD) of clofarabine in a~     combination with a myeloablative dose of busulfan. This is an initial step in developing a~     novel myeloablative preparative regimen for allogeneic hematopoietic stem cell~     transplantation (HSCT). While this phase I trial will initially develop the regimen in~     patients with refractory disease, it is expected that it will find its best application in~     patients with less advanced disease~   "
235172|NCT00477529|"~     To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-008~     given every 3 weeks; to characterize the toxicities of ABI-008; and to determine the~     pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule.~   "
235173|NCT00477516|"~     The purpose of this study is to determine how levels of this newly-discovered hormone, called~     FGF-23, changes in the blood in response to a high calcium dialysis bath during a~     hemodialysis (HD) treatment, and how this relates to changes in the calcium and PTH levels.~     We are also studying the effects of dialysis and inflammation on the levels of Fetuin A.~      We intend to prospectively study a cohort of end stage renal disease (ESRD) patients on~     hemodialysis in order to determine whether FDF-23 levels independently affect~     non-suppressible PTH levels. The relationship between Fetuin A and inflammatory markers will~     also be determined. By dialyzing patients on 3.5 mEq/L calcium dialysate bath, we seek any~     relationship between ionized calcium, FGF-23 and PTH.~   "
235174|NCT00477503|"~     -  Primary Objective will be to evaluate the use of Ga-67 citrate as an alternative~          radiopharmaceutical for CSF imaging.~        -  Secondary Objective will be to evaluate the biodistribution, pharmacokinetics and~          radiation dosimetry of In 111 DTPA and gallium-67 after intrathecal injection during~          remission of leptomeningeal metastasis (LM) and during LM occurrence, remission and~          recurrence.~   "
235175|NCT00477490|"~     The purpose of this study is to investigate the efficacy and safety of several doses of the~     melt formulation of desmopressin in a broad population of adult patients with nocturia.~   "
235176|NCT00477477|"~     This study is designed to evaluate the efficacy of two diets, a low glycemic load diet and a~     low saturated fat diet, in the treatment of adolescents with some heart disease risk factors~     associated with being overweight, such as high blood pressure, pre-diabetes, and cholesterol~     problems. The objective of the study is to determine which diet improves these risk factors~     more. The design of the study is a modified feeding study, which requests that the~     participants eat all and only the food provided by the study for 8 weeks, most days per week.~     Dietary counseling by phone will continue between 2 and 6 months of the study and the effects~     of this maintenance period will be assessed at 6 months time.~   "
235177|NCT00477464|"~     This study is to evaluate the safety and efficacy of lapatinib taken together with~     capecitabine in Japanese patients. The study will proceed in two phases; the first~     phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters.~     If there are no major safety concerns in Part 1, the study will move into the second phase~     (Part 2) to further evaluate the safety and clinical activity.~   "
235178|NCT00477451|"~     We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with~     panic disorder. This study will provide an initial assessment of efficacy, and to continue to~     describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato~     Alprazolam on a doxapram-induced panic attack in patients with panic disorder.~   "
235179|NCT00477425|"~     This is a supplemental study designed to evaluate the effect of bevacizumab on QTc interval~     in cancer patients. Patients who have consented to participate in selected randomized~     controlled bevacizumab clinical trials will be invited to participate in this study.~   "
235180|NCT00477412|"~     The goal of this clinical research study is to learn if bortezomib (in combination with~     rituximab plus 2 different intensive chemotherapy regimens) can help to control the disease~     in patients with mantle cell lymphoma. The safety of these drug combinations will also be~     studied.~   "
235279|NCT00476086|"~     The purpose of this research study is to determine the feasibility and safety of giving the~     combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether~     or not this drug combined with radiation therapy works in treating women with Mullerian~     tumors of the uterus.~   "
235181|NCT00477399|"~     The effect of non-surgical methods for obesity treatment are not fully documented. This study~     focus on the long term effect of an intensiv follow up (the Evje Model) compared to a~     regular follow up.~      The Evje Model is a combined model, consisting of repeated stays at a specialist centre,~     telephone follow up at home, home groups, self monitoring and close contact with the~     patients' local physician.~   "
235182|NCT00477386|"~     Based on these pre-clinical data, which were generated by our group, the investigators~     propose to test in a phase I/II clinical trial the following hypothesis: demethylation~     induced by decitabine results in re-sensitization to platinum in recurrent ovarian cancer.~      To test this hypothesis, the investigators will treat patients with recurrent ovarian cancer~     platinum resistant (recurrence within 6 months from platinum therapy) or platinum-refractory~     (no response to platinum) with a combination consisting of decitabine and carboplatin.~      This will be an institutional open label phase I/II trial to determine the safety and the~     biologic activity of the Decitabine/Carboplatin combination.~      The investigators will determine whether Carboplatin can be safely combined with Decitabine,~     the optimal dose schedule and the investigators will define whether at this dosage, the~     regimen is biologically active (i.e. induces demethylation of target genes).~      In the second part of the trial, the investigators will determine the clinical activity of~     the combination in a population of patients with platinum-resistant ovarian cancer.~   "
235183|NCT00477373|"~     To assess the efficacy of Di-valproate in Bipolar I patients suffering from a manic episode~     according to DSM IV (APA 1994) over a 12 weeks period of treatment.~      To evaluate the clinical safety of Di-valproate.~   "
235184|NCT00477360|"~     The primary objective of this study is to examine quality of life outcomes in patients who~     have undergone a humeral surface replacement hemiarthroplasty.~   "
235185|NCT00477347|"~     To compare closed-loop anesthesia to manual administration of propofol and remifentanil~     during liver transplantation~   "
235186|NCT00477334|"~     This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment~     in Black patients with recurrent genital herpes~   "
235187|NCT00477321|"~     This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV~     infection. Animal studies have shown that IL-7 can improve the function and number of~     infection-fighting cells called T lymphocytes, or T cells. If this study shows that IL-7 is~     safe, additional studies will be done to see if it can improve the function or numbers of~     T-cells in HIV-infected persons.~      HIV-infected persons who have been receiving HAART therapy for at least 12 months before~     enrolling in the study and have been stable on this treatment for at least 3 months before~     enrollment may be eligible for this study.~      Participants have about 10 clinic visits over 3 months. They receive three injections of~     IL-7, one injection a week for 3 consecutive weeks. The injections are given as a shot under~     the skin in the arm or leg. On the day of each injection, the participant stays in the clinic~     for up to 8 hours or longer for observation and collection of blood samples. Three additional~     visits (one every 3 months) may be scheduled.~      During the study visits the following may be done:~        -  Medical history, physical examination, blood tests every visit.~        -  Electrocardiogram (EKG) at study days 0 (day of first dose), 1, 7 (day of second dose),~          14 (day of third dose) and 21.~        -  Chest x-ray study on day 21.~        -  Blood sample collections at frequent intervals during the first 96 hours after the first~          dose administration. A catheter (thin plastic tube) may be put into a vein in the arm~          and left in place to allow several blood samples to be drawn without repeated needle~          sticks.~        -  Urine tests several times during the study.~   "
235188|NCT00477308|"~     In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which~     showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow~     up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.~   "
235189|NCT00477295|"~     This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing~     regime to allow optimal zonisamide or carbamazepine therapy for individual subjects.~     Assessment of eligibility will take place at the Screening Visit. The subjects will be~     randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1~     must occur as soon as possible (and at least within 14 days) of the Screening Visit in order~     to optimize subject care.~   "
235190|NCT00477282|"~     The objective of this study is to assess the safety and efficacy of karenitecin versus~     topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer.~     Additionally, this study will assess the ability of karenitecin to extend the time to disease~     progression, extend the overall survival time, and reduce the incidence and severity of~     treatment related hematological toxicities in patients with advanced epithelial ovarian~     cancer.~   "
235191|NCT00477269|"~     This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in~     patients with pulmonary arterial hypertension~   "
235192|NCT00477256|"~     Primary Objectives:~        1. To examine illness-related factors (i.e., severity of illness, quality of life rating)~          as predictors or correlates of child adjustment to pediatric cancer.~        2. To examine illness-related factors (i.e., severity of illness, quality of life rating)~          as predictors of school reintegration (i.e., school attendance) in children with~          pediatric cancer.~        3. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of~          child adjustment to pediatric cancer.~        4. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of~          school reintegration (i.e., school attendance).~      Secondary Objectives:~        1. To examine a second within-parent factor (i.e., parental perception of child~          vulnerability) as a predictor or correlate of child adjustment to pediatric cancer.~        2. To examine a second within-parent factor (i.e., parental perception of child~          vulnerability) as a predictor or correlate of school reintegration (i.e., school~          attendance) in children with pediatric cancer.~        3. To develop a statistical model by which relative contributions of each predictor~          variable (i.e., severity of illness, quality of life, parental stress, parental~          perception of child vulnerability), as well as their interrelatedness, can be understood~          in relation to child adjustment. Exploration of each variable's contribution will affect~          the schematic organization of the model.~        4. To examine demographic variables as covariates in the primary analyses. The variables~          include: child's age, gender, grade, ethnicity, diagnosis, time since diagnosis, type~          and duration of treatment, and time since school reintegration.~   "
235193|NCT00477243|"~     Primary Objectives:~        1. To determine whether the degree of spirituality/religiosity as determined by the Duke~          University Religion Index and Functional Assessment of Chronic Illness Therapy-Spiritual~          Well Being Scale (FACIT-Sp) correlates with internal locus of control as determined by~          the Locus of Control Scale.~        2. To determine the relationships among spiritual-well being, religiosity, hope,~          depression, and culture, socioeconomic status, and gender in a palliative care setting.~        3. To determine if hope and depression in palliative care patients are affected by the~          degree of intrinsic and extrinsic spirituality/religiosity.~        4. To determine if patients who believe in predestination correlate with decreased locus of~          control, but improved quality of life and degree of religiosity.~   "
235194|NCT00477230|"~     The purpose of the study is to compare two types of treatment for atrial fibrillation (AF)~     that are designed to treat the symptoms of atrial fibrillation. The treatments being compared~     are:~        -  A single catheter ablation procedure with the investigational EAS, a visually-guided,~          light-energy catheter~        -  Standard drug therapy (antiarrhythmic drugs)~      To learn more about the CardioFocus ENABLE investigational clinical study, please contact the~     study site closest to you.~      Eligibility Criteria~      Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study~     eligibility criteria include:~        -  18 to 80 years of age~        -  Frequent episodes of AF~        -  Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)~        -  Other criteria~   "
235195|NCT00477217|"~     This study will assess the safety and efficacy of zoledronic acid in patients presenting with~     spontaneous osteonecrosis of the knee.~   "
235196|NCT00477204|"~     The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin~     in adolescents with Type 1 Diabetes and to determine the amount of decrease in~     LDL-cholesterol.The study hypothesizes that simvastatin and ezetimibe/simvastatin will be~     safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.~   "
235197|NCT00477191|"~     People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and~     high blood pressure than the general public. The purpose of this study is to determine how~     substances produced in the fat (inflammatory markers) relate to the risk of heart disease in~     people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin~     resistance, increased waist size, high blood pressure, or high cholesterol.~   "
235198|NCT00477178|"~     20 chronic pain patients using codeine are compared with 20 chronic patients not using~     opioids and 20 healthy volunteers with respect to driving ability measured by~     neurophysiological tests and driving in a car simulator.~   "
235199|NCT00477165|"~     Hypotheses:~        1. Primary null hypothesis: The rate of clinical response, assessed as patient-reported~          global symptom rating and adequate relief of IBS symptoms, does not differ between~          non-depressed IBS patients treated with the SSRI citalopram and patients treated with~          placebo.~        2. Secondary null hypotheses:~             1. Changes in disease-related quality of life, assessed with the IBS-QOL instrument,~               do not differ between patients treated with the SSRI citalopram and patients~               treated with placebo.~             2. Changes in rectosigmoid visceral sensitivity, assessed by barostat balloon~               distention, do not differ between patients treated with the SSRI citalopram and~               patients treated with placebo.~   "
235200|NCT00477152|"~     The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous~     (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the~     rehydration of pediatric patients with mild to moderate dehydration.~   "
235201|NCT00477139|"~     This is a pilot study to gather preliminary data on the baseline immunologic status of~     patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for~     future clinical trial.~   "
235202|NCT00477126|"~     To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.~   "
235203|NCT00477113|"~     The Primary objective of this study is to determine the incidence and pattern of serious~     infections, malignancies, and other serious adverse events (SAE) in participants with~     multiple sclerosis (MS) treated with Tysabri (natalizumab).~   "
235204|NCT00477100|"~     The goal of this research study is to collect blood and tissue samples and clinical data from~     patients with inflammatory breast cancer (IBC) or highly suspicious for IBC. The blood and~     tissue samples and clinical data will be stored in a research tissue bank and used to help~     researchers try to better understand IBC.~      This is an investigational study. Up to 1200 patients will take part in this study. Up to~     1000 will be enrolled at MD Anderson.~   "
235205|NCT00477087|"~     The purpose of this study is to evaluate the effect of the combination of mitoxantrone and~     granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS)~     and overall survival (OS), in patients with hormone-refractory prostate cancer.~   "
235206|NCT00477074|"~     The role of HGF and KGF in COPD is poorly known. Plantier et al found that cultured~     fibroblasts harvested from patients with emphysema produced less HGF (but similar amounts of~     KGF) than controls, and Bonay et al found a direct relationship between the severity of~     airflow obstruction and HGF mRNA content in lung samples of smokers. These two studies~     suggest, therefore, that the pulmonary regulation of HGF may be abnormal in patients with~     COPD. However, both HGF and KGF can also be released by extra-pulmonary organs, thus having~     the potential to act systemically. Given the current clinical relevance attributed to the~     systemic effects of COPD, in this study we compared the levels of HGF and KGF in the~     pulmonary (bronchoalveolar lavage (BAL) fluid) and systemic compartment (circulating blood)~     of smokers with and without COPD and never smokers.~   "
235207|NCT00477061|"~     The purpose of the study is to evaluate morphine effect on pain reduction and diagnostic~     accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis.~   "
235208|NCT00477048|"~     Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who~     have chronic indinavir (IDV) associated nephrotoxicity.~   "
235209|NCT00477035|"~     The purpose of the study is to conduct a phase I study of adoptive immunotherapy with~     autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate~     in autologous stem cell transplant patients with high-risk hematologic malignancies.~   "
235280|NCT00476073|"~     Open, parallel group design. The study has a screening phase and a 12 week treatment phase.~     Subjects will be randomised to treatment in a 1:1 ration.~   "
235212|NCT00476996|"~     This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in~     patients with active rheumatoid arthritis who have an inadequate response to at least one~     anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous~     ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment~     will be administered at weeks 24 and 26. All patients will receive stable doses of either~     concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive~     additional DMARDs. The anticipated time on study treatment is 1-2 years. Target sample size~     is 1000.~   "
235213|NCT00476983|"~     Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500/100mg once daily~     plus TDF/FTC300/200mg once daily.~   "
235214|NCT00476970|"~     The goal of this study is to implement and in a controlled randomised trial test a program to~     identify and overcome barriers to CRC screening and thus improve CRC screening rates at MGH~     Chelsea HC.~      Our hypothesis is that a bilingual navigator program, enhanced by using trained interpreting~     staff will improve CRC screening rates at MGH Chelsea HC overall, and decrease disparities~     between patients with limited English proficiency and English speakers~   "
235215|NCT00476957|"~     The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200~     hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late~     stent thrombosis resulting in less deaths and myocardial infarctions.~      Study Stents:~      Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis~     Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary~     Stent or next generation model~      Primary Objective: To compare overall stent thrombosis rate of the Endeavor® Zotarolimus~     Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a~     patient population requiring stent implantation~      Secondary Objective: To compare the composite endpoint of total death or cardiac death~     combined with the number of patients with all non-fatal myocardial infarctions as well as the~     number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus~     Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a~     patient population requiring stent implantation.~      To assess the safety and efficacy in patient subgroups with specific demographics, clinical~     indications and/or vessel- or lesion characteristics.~   "
235216|NCT00476944|"~     The purpose of this study is to compare the rates of vascular related complications in~     patients undergoing percutaneous coronary intervention assigned to one of two arms: 1)~     bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide~     (Integrilin®)) use.~   "
235217|NCT00476931|"~     The purpose of the study is to study the clinical effects of the investigational drug, SB-509~     versus placebo in patients with diabetic neuropathy.~   "
235218|NCT00476918|"~     Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular~     edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage~     versus a low dosage.~   "
235219|NCT00476905|"~     The goal of this clinical research study is to evaluate the use of an imaging technology~     called spectral diagnosis. Researchers want to find out if a special spectral-diagnosis probe~     can be used to detect skin cancers.~   "
235220|NCT00476892|"~     The aim of this study is to determine the effectiveness and cost-effectiveness of pelvic~     floor muscle training in the management of pelvic organ prolapse in women.~   "
235221|NCT00476879|"~     The purpose of this study is to examine the effects of growth hormone during fasting in~     healthy lean men.~   "
235222|NCT00476866|"~     Background: To determine whether intermittent positive-pressure breathing (IPPB) improved~     lung compliance, work of breathing, and respiratory function in patients with recent high~     spinal cord injury (SCI).~      Methods: Two months of IPPB and two months of conventional treatment have to evaluated~     prospectively in random order in 14 patients with SCI. Noninvasive lung function tests and~     arterial blood gas measurements have to be obtained repeatedly. Repeated measurements of~     dynamic compliance and work of breathing have to be performed in 7 of the 14 patients.~   "
235223|NCT00476853|"~     A 48 week, randomized, open-label, two arm study to compare the efficacy, safety and~     tolerability of HAART containing nevirapine 400 mg/day versus nevirapine 600 mg/day in HIV-1~     infected patients started at 2-6 weeks after initiating rifampicin containing~     antituberculosis therapy.~   "
235224|NCT00476827|"~     Our hypothesis is that this study design, in which bevacizumab is added to one of six single~     agent chemotherapies with proven activity in metastatic breast cancer, will result in~     regression or stabilization of this disease in a safe and tolerable manner.~   "
235225|NCT00476814|"~     Primary Sclerosing Cholangitis (PSC) is a chronic disorder of the liver causing jaundice and~     liver damage. When Cystic Fibrosis affects the liver, the damaged liver looks like the liver~     in PSC. This study is designed to answer the question whether isolated PSC may be a form of~     CF only in the liver~   "
235226|NCT00476801|"~     The purpose of this investigation is to evaluate the effectiveness of an investigational~     device which is similar in appearance to a tanning bed but which emits ultraviolet~     irradiation of a specific wavelength known as UVA1. This device has not been approved by the~     FDA for general use in this country, as yet, but it has been used quite successfully in~     Europe for several years in treating such conditions as scleroderma, keloids, and other~     fibrosing conditions of the skin. Your participation in this study may yield important~     information regarding the safety and effectiveness of this form of light therapy for the~     treatment of these skin conditions which, at present, are difficult to treat.~   "
235227|NCT00476788|"~     This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII)~     therapy in young children using a novel delivery method in the form of a self-contained,~     lightweight, and disposable insulin pump unit controlled with a wireless handheld device. The~     outcomes of interest are the feasibility and potential metabolic benefits of this approach.~     We anticipate that the initiation of this CSII device in the immediate post-diagnosis period~     in this population will result in good glycemic control and greater parental satisfaction~     when compared to intensive insulin injection therapy.~   "
235228|NCT00476775|"~     A randomized controlled trial to test the efficacy of an after school ethnic dance program~     plus a culturally-tailored, home-based screen time reduction intervention to reduce weight~     gain (body mass index) among lower socioeconomic status, pre-adolescent Latina girls.~   "
235229|NCT00476736|"~     Treatment of COPD patients depends on the stage of the disease. First of all it is strongly~     recommended quit smoking, then bronchodilators drugs are added. In more advanced stages~     inhaled corticosteroids and pulmonary rehabilitation are added. In hypoxemic patients a long~     term supplemental oxygen is advised.~      The addition of sputum modifiers drugs is equivocal, since no objective improvement was~     documented.~      N-Acetylcystein (NAC) is a drug known for its anti-oxidant and mucolytic activity. In animal~     models of disease it showed its beneficial activity , whereas in human such changes weren’t~     demonstrated. In all the studies FEV1 was used to demonstrate the beneficial effect of the~     drug, although the disease changes are at the level of small airways which is almost not~     expressed by the measurement FEV1.~      Purpose of the study~        1. To estimate the damage severity at the small airways.~        2. To estimate the change in quality of life.~        3. To assess the pulmonary function changes at rest and following exercise, including~          parameters of air trapping (hyperinflation)~      Methods & Materials Patients – Inclusion - 30 Moderate COPD (GOLD classification) , AGE~     45-70, both sexes. Treated with inhaled steroids and long acting beta agonists.~      Exclusion – Active ischemic heart disease, heart failure, orthopedic problems that preclude~     ergometric bicycle activity.~      Questionnaire – The St. George questionnaire for quality of life will be used . Pulmonary~     function testing- Lung volumes and spirometry un including inspiratory capacity will be~     measured before and after exercise.~      Study protocol – 2 weeks run in, for observation disease stability and drug adherence.~      Patient will randomly separated in 2 groups . Group A – will receive 600-1200 mg N-acetyl~     cystein twice daily. Group B – will receive as control placebo . Following 4 weeks of~     treatment patient will clinically re-examined and PFT's performed as described. After 2 weeks~     of washout group A. will serve as control and group B. will be treated with NAC as described.~   "
235230|NCT00476723|"~     The trial will randomise HIV/HBV co-infected individuals to different HBV-active~     antiretroviral therapy treatment regimens.~   "
235231|NCT00476710|"~     This project will compare the amount of bile acids and their kinetics in overweight and obese~     people with normal glucose metabolism, impaired glucose tolerance and frank type 2 diabetes.~     We hypothesize that bile acids will behave differently in these groups. We will also explore~     the effects of Colesevelam HCl, a medicine that lowers LDL cholesterol by binding bile acids,~     on bile acids in those groups. We hypothesize the drug may have different actions on bile~     acids in subjects with different degrees of abnormal glucose metabolism.~   "
235232|NCT00476697|"~     The purpose of this investigation is to evaluate the effectiveness of high-dose UVA1~     irradiation in the treatment of fibrosing conditions of the skin, e.g., keloid (a thick scar~     from growth of fibrous tissue), scleroderma (deposits of fibrous tissue in the skin) and acne~     keloidalis nuchae (keloids on the back of the neck or hairline) old burn scars, granuloma~     annulare or other similar skin conditions. This UVA1 dosing schedule has been used~     successfully in Germany for various skin diseases, such as the above mentioned scleroderma.~   "
235233|NCT00476684|"~     There is conflicting evidence on whether radio-frequency neurotomy of the medial branch has a~     significant effect on pain in patients with chronic unilateral facet joint neck and back~     pain.~      We will evaluate radiofrequency treatment on medial-branch of the ramus dorsalis as an~     effective pain treatment for patients with chronic pain originated from facet-joints in~     cervical and lumbar columna.~   "
235234|NCT00476671|"~     To assess the prevalence and risk factors of neurocognitive impairment and psychiatric~     comorbidities in HIV infected patients who have undetectable viral load, have been on HAART~     for at least 1 year and have no history of CNS infection.~   "
235235|NCT00476658|"~     Quantification of macrophage infiltration and characterization of macrophage phenotype in~     adipose tissue of 60 obese subjects and 20 non obese subjects~   "
235236|NCT00476645|"~     The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of~     tumor progression in patients who have developed androgen-independent (AIPC) or~     hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific~     antigen (PSA).~   "
235237|NCT00476632|"~     The goal of this research study is to identify biologic and lifestyle factors that may~     increase a person's risk of developing certain types of cancer.~   "
235238|NCT00476619|"~     Full Title: A Randomized Controlled Trial of Procrit for the Prevention of Acute Renal~     Failure in Patients Receiving Intravenous Contrast~      Primary Objective: To evaluate the efficacy of a one-time dose of intravenous erythropoietin~     administration in the prevention or attenuation of contrast-induced acute renal failure.~      Secondary Objectives: To evaluate serum and urinary markers of renal injury, including KIM-1,~     BMP-7, and TGF-b, along with other biomarkers, in subjects receiving intravenous contrast and~     correlate their expression with clinical outcomes~      Study Design: Prospective, multi-centered, randomized, double blind, placebo controlled trial~     of a one-time dose of EPO. Subjects will be followed for seven days or until hospital~     discharge, whichever is longer. Total estimated study duration 3 years.~   "
235239|NCT00476606|"~     To evaluate clinical and immunological outcome of children treated with HAART.~   "
235240|NCT00476593|"~     Retinal optical coherence tomography (OCT) is an established technology which enables a~     detailed cross-sectional visualization of the retinal micro-anatomy, and an objective~     measurement of its thickness in-vivo. Multifocal electroretinogram (MfERG) measures function~     of the central retina. Both technologies are relatively new and they provide complimentary to~     each other information on retinal anatomy and function.~      The aims of this study is to establish normal ranges for OCT and mfERG measurements related~     to age, gender and reproductive factors such as parity and the use of contraception in~     Norwegians; to assess the presumably healthy central retina with the use of anti-inflammatory~     medication with relation to age and sex ; to study the frequency and extent of retinal~     thickening and change in retinal function in patients with anterior uveitis not complicated~     with macular edema; to assess whether the presence of the HLA-B27 haplotype or uveitis~     recidive affects macular thickening/function in uveitis.~   "
235241|NCT00476580|"~     Objectives:~      General objective:~      To determine how acculturation to United States has influenced the health and cancer risk~     among a US migrant Sri Lankan population.~      Specific objectives:~        1. To determine the prevalence of cancer and cancer related non-communicable diseases among~          Sri Lankan Sinhalese living in the greater Houston area.~        2. To study the distribution of risk factors for cancer in this population.~        3. To study the pattern of utilization of methods available for early detection of cancer~          in this population.~        4. To study and compare the findings of this survey with that of the siblings of this~          population living in Sri Lanka.~   "
235443|NCT00473915|"~     Eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis~     or hayfever. The purpose of this study is to learn whether placing allergen (the substance~     that causes allergies) in the nose several days in a row will cause an increase in eye~     symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.~   "
235242|NCT00476567|"~     There is a great lack of results from randomized clinical trials with high methodological~     quality, assessing the effects of exercise during pregnancy. The main aims of this trial is~     to study the effects of exercise during pregnancy in the prevention and treatment of disease~     and complications which may arise during pregnancy:~        -  Does regular exercise during pregnancy aid in preventing gestational diabetes?~        -  Does regular exercise during pregnancy prevent low back and/or pelvic girdle pain?~        -  Does regular exercise during pregnancy prevent urine and/or fecal incontinence?~        -  Does regular exercise during pregnancy have an effect on labour and delivery?~        -  Does regular exercise during pregnancy prevent maternal excessive weight gain and fetal~          macrosomatia?~   "
235243|NCT00476554|"~     This is an open label, randomized phase II study designed to evaluate the tolerability and~     response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell~     lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2~     systemic therapies.~   "
235244|NCT00476541|"~     The overall objective is to improve the cure rate of children with newly diagnosed acute~     myeloid leukemia (AML) who undergo risk-adapted therapy.~      Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics and~     response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg)~     will be evaluated.~   "
235245|NCT00476528|"~     The purpose of this study is to investigate if a systematic intervention with early~     identifying of patients with posttraumatic amnesia using a reality orientation therapy can~     reduce the period with posttraumatic amnesia in order to get a better outcome for patients~     with traumatic brain injury~   "
235246|NCT00476515|"~     Primary Objectives:~        -  Conversion of a positive donor specific cross-match to a living donor to a negative~          cross-match thereby allowing successful renal transplantation.~        -  Transplant success or failure following the desensitization protocol.~        -  Determination of the effect of rituximab on the kinetics of donor specific antibodies~          (DSA).~        -  Determination of the effect of rituximab on the kinetics of B-cell subpopulations in~          peripheral blood and/or secondary lymphoid organs (lymph node biopsies at time of~          transplant, if available) in both responders and non-responders using flow cytometry~          and/or immunohistochemistry.~      Secondary Objectives:~      -Decrease in incidence of humoral rejection to less than 50 % at 1 year.~   "
235247|NCT00476502|"~     Study of genetic polymorphisms of CYP #A and MDR-1 genes in Thai HIV-1 infected patients on~     saquinavir/ritonavir.~   "
235248|NCT00476489|"~     The purpose of this study is to determine if topical steroids treatment for different skin~     diseases suppress the adrenal cortisol production.~   "
235249|NCT00476476|"~     In this research study we are looking to see how vulvar cancer responds to erlotinib therapy.~     Two distinct patient populations are targeted: women with locally advanced measurable~     squamous cell carcinoma of the vulva, primary or recurrent, who are candidates for definitive~     treatment with surgery or chemoradiation (Cohort 1) and women with radiographically~     measurable distant metastatic cancer either at time of presentation or with recurrence~     (Cohort 2). Another goal of this study is to learn more about the proteins and genes present~     in vulvar cancer and how they may affect response to erlotinib. Erlotinib treats cancer by~     preventing cancer cells from growing and multiplying. It does this by blocking certain~     proteins that are on the surface of some types of cancer cells. Laboratory tests show that~     vulvar cancer cells have high levels of these proteins.~   "
235250|NCT00476463|"~     Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce~     emergence of resistant strains. Several new therapeutic agents are currently in development,~     however combination therapy trials in the HBV-infected population have only recently~     commenced. No such trials have been undertaken in the HIV/HBV co-infected population.~   "
235251|NCT00476450|"~     This study will examine bacteria in patients mouths at different times during stem cell~     transplantation and recovery. Drugs patients receive as part of the conditioning process for~     a stem cell transplant increase their risk of infection. There might be a link between the~     bacteria in the mouth and the bacteria that can cause infections. Knowing the changes in~     bacteria might help researchers determine the best method to prevent infections.~      Patients 18 years of age and older who are scheduled to receive a stem cell transplant may be~     eligible for this study.~      Participants undergo the following procedures:~      Review of medical records~      Interview about their oral care~      Oral examination~      Collection of oral specimens just before the stem cell transplant, immediately after the~     transplant, and 3 weeks after the transplant. The specimens are obtained as follows:~        -  <TAB>-About one-fourth teaspoon of saliva is collected with a suction device similar to~          that used in a dental office.~        -  <TAB>-Plaque from the surface of a tooth is collected with a plastic toothpick.~        -  <TAB>-Skin cells from the inside of the cheek and the surface of the tongue are~          collected with a small soft brush.~        -  <TAB>-If a tube is inserted into the patient s lungs to assist breathing and the patient~          is admitted to the intensive care unit, a specimen from the lungs is collected.~      Patients are followed for 100 days after their transplant. Additional oral specimens are~     obtained from those who develop signs and symptoms of respiratory infection.~   "
235252|NCT00476437|"~     This trial is conducted in Japan. The purpose of this trial is to investigate the safety and~     the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients~     with type 2 diabetes mellitus.~   "
235253|NCT00476424|"~     A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected~     subjects.~   "
235254|NCT00476411|"~     The prevalence of Hepatitis B core antigen in the Thai population is about 70 %, no data of~     isolated Hepatitis B core antigen is reported. Hepatitis B core antigen is observed in~     10%-20% of individuals from low endemic areas of HBV infection. However, this prevalence of~     isolated antiHBc would be higher in endemic area of HBV infection. There is conflicting data~     of occult HBV infection in HIV infected patients. In Thailand, perinatal transmission is the~     main route of transmission which is different from developed countries. Therefore, isolated~     antiHBc in Thai people has longer duration than low prevalence regions. Moreover, HBV~     genotype C and B is common in this region. If the HBV vaccination could eliminate an occult~     HBV infection in these individuals, the liver related mortality might be reduced. The~     prevalence and clinical importance of isolated antiHBc in Thai have not been investigated~     yet. There is also limited data of HBV vaccine response in this setting.~   "
235255|NCT00476398|"~     The purpose of this study is to find out how common diseases of the esophagus can cause chest~     pain. Gastroesophageal reflux disease (GERD), commonly known as heartburn, is a common cause~     of chest pain in patients that do not have heart problems. The study test is called PillCam~     Eso, it is a small, pill sized capsule that has a small camera inside it. The camera will~     take pictures of the esophagus and the stomach as it goes down. Findings of the PillCam Eso~     will be compared to findings during conventional upper endoscopy.~   "
235256|NCT00476385|"~     Primary objective:~      to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for~     MAXOMAT®, in children, for 1 year.~   "
235257|NCT00476372|"~     Background: Approximately 40% of patients with Parkinson's disease (PD) have cognitive~     impairments. There is a lack of consensus as to the extent to which psychiatric symptoms,~     depression, age at disease onset, disease duration, and medication is related to the type and~     severity of cognitive impairment. This discrepancy can in part be caused by the lack of~     distinction between patients with different motor symptoms and disease severity.~      Objective: To identify the extent to which psychiatric symptoms, depression, age at disease~     onset, disease duration, and medication is related to the severity and type of cognitive~     dysfunction in patients with idiopathic PD categorized according to motor symptoms and~     disease severity.~      Methods: the population of patients with PD in the old county of Aarhus is described on the~     background of medical records, and stratified in accordance to age, sex and cardinal~     symptoms. Through proportional allocation a sample of a minimum of 50 patients with PD is~     drawn from the population. The patients and 30 healthy matched controls will undergo~     comprehensive neuropsychological assessment including tests of language, memory, executive~     function, and visuospatial function. Furthermore, all participants will be screened for~     depression (Geriatric Depression Scale) and psychiatric symptoms (Neuropsychiatric Inventory~     and Symptom Checklist). The patients will be categorized in accordance with their motor~     symptoms via cluster analysis for the purpose of analyzing the effect of psychiatric~     symptoms, depression, and age of disease onset, disease duration, and medication on~     cognition.~   "
235258|NCT00476359|"~     To evaluate the pharmacokinetics (PK) of LPV/r with saquinavir in HIV-1 infected children. To~     evaluate treatment response (clinical, immunological and virological) to LPV/r, SQV in Thai~     children.~   "
235259|NCT00476346|"~     We conducted a double-blind, placebo-controlled randomized clinical trial of calcium and~     vitamin D supplementation in 5201 female Naval recruits. During 8 weeks of basic training,~     supplementation with 2000 mg calcium and 800 IU vitamin D/day decreased incidence of stress~     fracture by 25%. The hypothesis was:~      Supplementation with calcium 2000 mg/d and vitamin D 800 IU/d will significantly reduce the~     incidence of stress fractures in female Navy recruits during 8 weeks of basic training.~   "
235260|NCT00476333|"~     Introduction: Kinetic, kinematic and electromyographic activity of the lower limb have been~     shown to be influenced by various footwear-generated biomechanical manipulations (e.g. soles.~     Insoles, orthoses). A novel biomechanical device comprising four modular elements attached~     onto foot-worn platforms was recently developed. Each element can be individually calibrated~     (Position, convexity, height and resilience) to induce a specific biomechanical challenge.~      Objectives: The aim of this study is to evaluate the influence of specific biomechanical~     challenges on Kinetics, kinematics and electromyographic activity of the lower limb.~      Design: Prospective, case control Setting: Motion analyses will be conducted during level~     walking with (1) a three-dimensional motion analysis system and (2) ground reaction force~     analysis using force platforms (3) Electro-Myography system. Each subject will be examined in~     16 different settings of the biomechanical system~   "
235261|NCT00476320|"~     Myocardial deformation imaging allows analysis of myocardial viability in ischemic left~     ventricular dysfunction. This study will evaluate the predictive value of myocardial~     deformation imaging for improvement in cardiac function after revascularization therapy in~     comparison to contrast-enhanced cardiac magnetic resonance imaging (ceMRI).~      In 55 patients with ischemic left ventricular dysfunction, myocardial viability was assessed~     using pixel-tracking-derived myocardial deformation imaging and ceMRI to predict recovery of~     function at 9±2 months follow-up. For each left ventricular segment in a 16-segment model~     peak systolic radial strain will be determined from parasternal 2D echocardiographic views~     and the amount of late hyperenhancement (LE) and maximal thickness of myocardial tissue~     without LE using ceMRI. The hypothesis is that compared with segments showing functional~     improvement, those that failed to recover had lower radial strain and lower thickness without~     LE and higher LE.~   "
235262|NCT00476307|"~     This study is designed to test the immunogenicity and reactogenicity of the~     Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008~     season.~   "
235263|NCT00476294|"~     Objectives:~      The objective of this long-term observational study is to assess progression-free survival~     and overall survival for a period of five years following the first dose of study treatment~     (placebo or plerixafor [AMD3100]) in protocol AMD3100-3102. Patients that received at least 1~     dose of study treatment (placebo or plerixafor) in the multicenter, randomized, double-blind,~     placebo-controlled AMD3100-3102 study, which was designed to evaluate plerixafor plus~     granulocyte colony stimulating factor (G-CSF) versus placebo plus G-CSF to mobilize~     hematopoietic stem cells for autologous transplantation of Multiple Myeloma (MM) patients are~     eligible.~   "
235281|NCT00476060|"~     The standard treatment for decompensated cirrhosis is liver transplantation, however, it has~     several limitations. Recent animal studies suggest that bone marrow stem cell transplantation~     can lead to regression of liver fibrosis. The investigators have already completed the phase~     1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with~     cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results~     (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find~     efficacy of this new treatment strategy in the setting of a multicenter, randomized~     placebo-controlled trial in 50 patients with decompensated cirrhosis.~   "
235282|NCT00476047|"~     This phase II trial studies how well tositumomab and iodine I 131 tositumomab works in~     treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)~     that have had their first decrease in or disappearance of signs and symptoms of cancer (first~     remission). Monoclonal antibodies, such as tositumomab and iodine I 131 tositumomab, may~     block cancer growth in different ways by targeting certain cells.~   "
235264|NCT00476281|"~     Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of~     patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an~     increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with~     accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years~     before the diagnosis of CFRD implying that impaired glucose tolerance may be very early~     detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms~     and reduce complications. However, at the state of impaired glucose tolerance or fasting~     hyperglycaemia, current screening methods are not suitable for the early management of~     hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS),~     which provides a continuous glucose profile, has revealed to be clinically relevant in the~     investigation of glucose excursions over a long period. This device, widely use in diabetic~     non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects.~     Previous studies of continuous glucose monitoring have been realized in CF patients with~     normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is~     to evaluate the glucose profile with continuous glucose monitoring the nutritional and~     respiratory status in cystic fibrosis subjects, according to their glucose tolerance.~   "
235265|NCT00476268|"~     Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with~     moderate to severe persistent asthma.~   "
235266|NCT00476255|"~     This study examines the Pediatric Emergency Department as a location for increasing safe car~     seat practices by parents who are not restraining their children appropriately in motor~     vehicles. Three different intervention will be tested to determine their effectiveness in~     increasing safe car seat practices: usual emergency department care; provision of printed~     materials; and a brief motivational intervention in the emergency department.~   "
235267|NCT00476242|"~     Prospective participants will undergo a screening process at the clinic to determine~     eligibility. After screening, eligible patients will complete an 8-day inpatient~     detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to~     one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid.~     Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month~     (the total of three injections) while memantine or placebo will be taken daily. In addition,~     patients will receive twice weekly psychosocial intervention that will include motivational~     interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also~     consist of 3 weekly visits to the clinic in which patients will receive counseling to help~     maintain abstinence and improve compliance with study medication.~   "
235268|NCT00476229|"~     Primary Objective:~      1. To determine whether the primary endpoint: the composite success rate, defined as the~     proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host~     Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have~     engrafted, is likely to be at least 40%.~      Secondary Objectives:~        1. To determine the cumulative incidence of chronic graft versus host disease.~        2. To determine the overall and disease free survival.~   "
235269|NCT00476216|"~     There is a direct association between cancer and thrombosis (blood clots). The purpose of~     this study is to determine the best dose of an antithrombotic (prevents blood clots) agent~     called fondaparinux in non-small cell lung cancer(NSCLC). Patients will also receive~     chemotherapy.~   "
235270|NCT00476203|"~     This purpose of this study is to test whether a 6-month yoga program improves quality of life~     and reduces fatigue and weight gain in breast cancer survivors.~   "
235271|NCT00476190|"~     The purpose of this study is to determine the safety and effectiveness of a multi-drug~     chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a~     regimen that is often used in pediatric patients and we will add drugs called~     PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in~     the past and has been used in treatment with both children and adults with ALL. Information~     from those other research studies suggests that intravenous PEG-asparaginase has been~     administered safely in both children and adults. We hope to gain more information about the~     participants disease and how it responds to standard chemotherapy drugs used to treat ALL>~   "
235272|NCT00476177|"~     The purpose of this study is to test the safety of adding donor dendritic cells to donor~     lymphocyte infusions, and to determine the type and severity of any side effects associated~     with this addition. Previously patients with hematologic malignancies who relapsed after~     transplant have been given infusions of donor white blood cells (donor lymphocyte infusion,~     DLI) as a way to boost their immune function and fight disease. Although DLI has led to~     cancer regression in some patients, the overall response rate using DLI alone is low, and~     unfortunately, rarely lasting. Researchers have discovered a new subset of blood cells,~     called dendritic cells (DC), which are crucial partners to lymphocytes in generating an~     immune response. We believe that the infusion of DC together with DLI may improve the ability~     of the donor lymphocytes to recognize and kill cancer cells.~   "
235273|NCT00476164|"~     Purpose of clinical trial; Evaluate the effectiveness of rituximab in C4d+ CAN~      Primary objective; To determine whether anti-CD20 therapy can stabilize or improve renal~     function and/or proteinuria in patients with C4d+, chronic (humoral) rejection in whom~     standard therapeutic approaches have failed.~      Secondary objective (s);~        -  To compare patient and graft survival between control and rituximab-treated groups~        -  To evaluate the adverse effect profile of rituximab in this group~        -  To correlate changes in circulating B cell numbers, anti-HLA and non-HLA Ab profiles and~          titre with responses to standard therapy and / or rituximab~        -  To correlate changes in T cell responsiveness to alloantigens with responses to standard~          therapy and / or rituximab~      Study Design; Prospective, randomised, two arm, open-labeled~      Study Endpoints; Primary~        -  Rate of deterioration in renal function, defined by slope of reciprocal creatinine plot,~          on samples taken 3-5 months post-randomisation.~        -  Change in degree of proteinuria, where present, at 3-5 months post-randomisation 2˚~          endpoints, determined at 3-5 months post-randomisation and at 1, 2 and 3 years~          post-recruitment are;~        -  Rate of deterioration in renal function, defined by slope of reciprocal creatinine plot,~          determined by analysis of samples taken since previous assessment.~        -  Patient survival~        -  Graft survival~        -  Incidence of culture positive infection~        -  Incidence of malignancy~        -  Degree of proteinuria~        -  Changes in circulating CD20+ cells in peripheral blood~        -  Changes in anti-graft Ab titres, (measured every 3 months)~        -  Changes in T cell responsiveness to alloantigens (measured every 3 months).~      Sample Size; 15 patients to be randomised to each arm (i.e. 30 patients randomised). Up to~     120 patients will need to be enrolled into the study. In addition, in those participants that~     received a living donor kidney, these donors will be approached to provide up to 5 samples of~     blood to help with the in vitro analyses.~      Summary of eligibility criteria;~        -  Male or female renal allograft recipients 18-70 years of age~        -  more than 6/12 post-transplantation~        -  Either deteriorating allograft function on reciprocal creatinine plot or significant~          proteinuria or both.~        -  C4d+/- CAN on renal allograft biopsy~      Investigational medicinal product and dosage; Rituximab, 1g on day 0 and 1g on day 14~      Active comparator product(s); None~      Route(s) of administration; Intravenous infusion~      Maximum duration of treatment of a subject; 14 days with rituximab. The treatment arms of the~     study, including optimisation period, formal run-in and post-randomisation phase lasts for 10~     months post-recruitment.~      Procedures; Screening & enrollment. Potentially eligible patients will be identified by~     screening renal allograft biopsies performed for 'creeping creatinine' and/or proteinuria.~     Recruitment by informed consent prior to enrollment.~      Procedures; Baseline. In addition to routine tests, blood for anti-HLA and non-HLA antibody~     analysis and for peripheral blood mononuclear cell (PBMC) purification.~      Procedures; Treatment period. 3 month run-in period on optimal conventional immunosuppressive~     therapy, preceded by up to 2 months to allow tailored-optimization. Patients will be reviewed~     at least six times in their normal transplant clinic appointments for routine blood~     biochemistry, full blood count and urine analysis. At the end of the run-in period, further~     blood will be taken for anti-graft antibody analysis and PBMC purification. Those patients in~     whom allograft function stabilises and/or proteinuria improves will have normal transplant~     clinic follow-up appointments and have blood taken for further anti-graft antibody and PBMC~     purification up to every 3 months for 3 years. Those with continued deterioration in either~     allograft function or persisting or worsening proteinuria will be randomised. These patients~     will be reviewed during their normal transplant clinic appointments until the primary~     end-point and will need to have at least 6 routine blood biochemistry, full blood count and~     urine analysis during the final 3 months of this period, post-randomisation. At the primary~     end-point, further blood will be taken for anti-graft antibody analysis and PBMC.~      Procedures; End of Study. •Follow up will continue for 3 years, with blood taken for~     anti-graft antibody analysis and PBMC purification every three months~      Procedures for safety monitoring during trial; Regular patient interviews and examination,~     routine haematological and biochemical analyses. Serious adverse events will be reported and~     forwarded to the sponsor, MHRA, LREC and Roche as appropriate The WLRATC transplant research~     committee will discuss the trial and any safety concerns at their regular three monthly~     meetings. Data will be reviewed after 30 and also after 60 people have been enrolled.~      Criteria for withdrawal of patients on safety grounds; Serious adverse effects related to~     rituximab infusion~   "
235274|NCT00476151|"~     This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1~     Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the~     lower extremities due to diabetic nerve pain.~   "
235275|NCT00476138|"~     The present study attempts to evaluate the potential beneficial effects of a flavonoid, the~     epigallocatechingallate, on retinal ganglion cell function, evaluated by pattern~     electroretinogram, in subjects with ocular hypertension or early glaucoma.~   "
235276|NCT00476125|"~     This study will examine the potential changes in the blood levels of a recently discovered~     metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that~     in healthy adults key regulatory factors involved in lipid oxidation will respond to changes~     in diet, particularly fasting and diet-induced ketosis.~   "
235277|NCT00476112|"~     This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of~     atrial flutter (AFL) to sinus rhythm.~   "
235278|NCT00476099|"~     To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol~     pMDI in a twice daily regimen in patients with stable severe COPD.~   "
235283|NCT00476034|"~     This 39-week, active controlled, study is designed to assess long-term efficacy, safety and~     tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who~     participated in the 13-week core CCOX189A2361 study.~   "
235284|NCT00476021|"~     This study is a randomized controlled trial comparing 6 month usage rates of the~     levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after~     vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of~     unintended pregnancy in the United States, particularly in postpartum women, there is a need~     for reliable, effective, long-term contraception such as the IUD in postpartum women.~     Postplacental insertion of intrauterine contraception would help to address this need. The~     primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal~     delivery will be higher in women who have immediate postplacental insertion as compared to~     delayed insertion 6-8 weeks following delivery.~   "
235285|NCT00476008|"~     The purpose of the study is to determine whether memantine delays the progression of driving~     impairment in patients with mild Alzheimer's Disease (AD).~   "
235286|NCT00475982|"~     The purpose of this study is to determine if weight loss prior to radical prostatectomy~     effects chemical substances in the blood stream and prostate tissue that may affect prostate~     cancer development and progression.~   "
235287|NCT00475969|"~     To see if duloxetine 60 to 120 mg once daily (QD) is better than placebo in the treatment of~     generalized anxiety disorder (GAD).~   "
235288|NCT00475956|"~     The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in~     combination with AZD0530, in treating patients with advanced solid tumours are safe,~     tolerable and efficacious.~   "
235289|NCT00475943|"~     This study will examine how the airway closes during swallowing to prevent food or liquid~     from entering the voice box or lungs while eating or drinking. It will also test whether~     electrical stimulation of muscles in the neck can close the airway as it would close during~     swallowing. The long-term goal of this research is to determine the feasibility of a new~     approach for helping patients with a severe and life threatening swallowing disorder.~      Healthy normal volunteers between 18 and 65 years of age who can swallow normally may be~     eligible for this study. Candidates are screened with a medical history, physical~     examination, electrocardiogram and nasolaryngoscopy. For the nasolaryngoscopy, the subject's~     voice box and epiglottis (flap of tissue that covers the windpipe during swallowing) are~     examined using a thin flexible tube with a camera attached that is passed through the nose to~     the back of the throat. During the test, speech and other tasks such as singing and whistling~     are observed. The camera records the movement of the vocal cords on videotape. This procedure~     may be repeated another time during the study.~      Participants undergo the following procedures:~        -  Electrical stimulation of muscles in the neck: The muscles in the neck are stimulated~          with brief low-level electrical currents to see if the stimulation can cause the~          epiglottis to fold down over the windpipe. Stimulation may be increased to a level where~          it feels like a small shock The subject is asked to try to do the muscle stimulation~          while swallowing.~        -  Videofluoroscopy (recording swallowing and muscle stimulation during x-ray imaging of~          the head): The head and neck are x-rayed while the subject swallows. After the wires~          have been inserted for EMG (see below), markers are glued to the tongue and a tube is~          inserted through the nose into the esophagus. The movements during swallowing with and~          without muscle stimulation are x-rayed and analyzed later to determine how the~          stimulation affects the movement of the epiglottis.~        -  Electromyography (EMG): Measurement of the electrical activity of muscles in the neck~          using fine wires placed through the skin into muscles in the chin.~        -  Manometry: During the videofluoroscopy, a manometer (tube that measures pressures) is~          placed through the nose and into the back of the throat at the entry point to the~          esophagus. This test shows whether muscle stimulation can fold down the epiglottis.~        -  Surface electromyography (sEMG): The tube used during the videofluoroscopy has small~          rings embedded in it that measure muscle activity on the surface of the inside of the~          throat.~   "
235290|NCT00475930|"~     Outbreaks of skin and soft tissue infections (SSTI) related to community associated~     Methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common in~     military training units. Risk factors for MRSA related SSTI such as crowding, poor hygiene~     and shared equipment are often hard to avoid in a military training environment, often~     designed to simulate battlefield conditions.~      It has recently been demonstrated that military recruits colonized with MRSA may be at~     increased risk of developing SSTI. Studies in the hospital environment have shown that~     decolonizing inpatients known to carry MRSA decreases the rates of MRSA related infections in~     the treated individuals and also in their inpatient unit as a whole.~      The investigators propose a randomized, double blind, placebo controlled trial to:~        1. Evaluate the effectiveness, feasibility, and safety of chlorhexidine body cloths,~          self-administered three times weekly, in preventing SSTI among recruits in military~          training facilities; and~        2. Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of~          Staphylococcus aureus colonization among military recruits.~   "
235291|NCT00475917|"~     The purpose of this study is to determine a safe dose of XL844 in combination with~     gemcitabine, how often it should be taken, and how well people with cancer tolerate the~     combination of gemcitabine and XL844.~   "
235292|NCT00475904|"~     The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4%~     amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)~   "
235293|NCT00475891|"~     The study will help in identifying the best empiric antibiotic option for Linezolid resistant~     Vancomycin-resistant Enterococci (VRE) infections. This research is important because it~     allows the determination of resistance rates to antibiotics that may not be frequently tested~     to by the clinical microbiology laboratory at UPMC-Presbyterian. It also will provide~     antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in~     identifying the best empiric antibiotic option for Linezolid-resistant VRE infections.~   "
235294|NCT00475878|"~     This study is designed to test whether treatment of depressive symptoms using escitalopram~     improves adherence to Buprenorphine and reduces symptoms of depression for individuals~     receiving Buprenorphine through their medical provider.~   "
235295|NCT00475865|"~     The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide~     administered once daily for 24 weeks, compared to placebo, in patients with multiple~     sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].~      The secondary objectives were:~        -  to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in~          combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters,~          relapse rate and patient-reported fatigue;~        -  to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with~          a stable dose of GA.~   "
235296|NCT00475852|"~     The purpose of this study is to find out if nesiritide (a human B-type natriuretic~     peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart~     failure, helps to improve breathing difficulties, reduce heart failure readmissions to~     hospitals, and helps patients live longer.~   "
235308|NCT00475696|"~     Examine the efficacy and safety of duloxetine in subjects with symptoms of bladder~     overactivity due to pure detrusor instability or sensory urgency. Subjects in study will be~     permitted to escalate or de-escalate between 80 mg/day and 120 mg/day in consultation with~     the investigator and based on their adverse events.~   "
235876|NCT00468143|"~     The purpose of this pilot study is to compare Adderall ® and Adderall XR ® in terms of their~     effectiveness and side effects for the treatment of ADHD in adults.~   "
235297|NCT00475839|"~     Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of~     older women. Stress urinary incontinence, the most common form of this disease, is treated~     primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of~     surgery being performed for recurrences. Many different surgical procedures have been~     described for the treatment of SUI and there is no general agreement as to the most~     effective. This study compares the safety and efficacy of the tension-free vaginal tape~     procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary~     incontinence.~   "
235298|NCT00475826|"~     Study Title: Evaluation of chylomicrons metabolism in sub-clinical atherosclerosis in~     patients whit Heterozigous Familial Hypercholesterolemia (FH) treated with statin plus~     ezetimibe.~      Background:~      Coronary artery calcification (CAC) is a marker of sub-clinical coronary atherosclerosis~     which correlates with higher risk of clinical events. It was already demonstrated that CAC is~     more prevalent in patients with FH compared with normal individuals. A number of studies~     demonstrated that plasmatic removal of chylomicrons is defective in patients with~     atherosclerosis. Despite the fact that is still controversial whether this impairment occurs~     in patients with HF when compared to normal controls, the kinetics of chylomicrons has not~     been studied in HF patients with and without atherosclerosis and more important, it is not~     clear if those changes may be observed in the sub-clinical disease, as reported for CAC in~     asymptomatic individuals.~      Previous studies have demonstrated the inverse correlation among LDL-C levels and the removal~     of remnants chylomicrons using artificial chylomicrons technique. It is also well known that~     high doses of more potent statins are more effective to remove chylomicrons from the plasma~     due to better expression of LDL-C receptors through plasma LDL-C reduction. It was not~     evaluated yet if the association of ezetimibe and statin, enhancing LDL-C receptors~     expression in the liver would enhance the efficacy of the monotherapy with statins to remove~     artificial chylomicrons in patients with HF.~      Study design:~      Open, randomized, single-blinded study in which twenty six outpatients from the Lipids~     Clinical Unit at the Heart Institute (INCOR), University of São Paulo, previously diagnosed~     with FH according to US MED PED criteria, without history of CD and a CAC evaluation by MSCT~     (Multiple Sensors Computed Tomography) in the previous year will be compared to 26 control~     individuals matched by age and sex collected from the database of the Lipids Metabolism~     Laboratory.~      Patients will be randomized to receive simvastatin 40 mg as monotherapy or in combination~     with ezetimibe 10 mg and will undergoing three kinetics studies to demonstrate the effects of~     simvastatin 40 mg on the kinetics of the chylomicrons along with other laboratorial dosages (~     lipid fractions, hepatic enzymes and CK).~      The primary endpoint of this study is to evaluate if there is any correlation among the~     reduction of the plasma clearance of chylomicrons by the artificial chylomicrons technique~     and the presence of sub-clinical atherosclerosis; the secondary endpoint is to evaluate if~     ezetimibe/simvastatin enhances the effects of simvastatin alone in the removal of~     chylomicrons in patients with HF.~   "
235299|NCT00475813|"~     Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild~     to moderate persistent asthma in pediatric subjects.~   "
235300|NCT00475800|"~     This 39-week, open label study is designed to assess long-term efficacy, safety and~     tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who~     participated in the 13-week core CCOX189A2360 study.~   "
235301|NCT00475787|"~     The purpose of this study is to determine the effectiveness of Chiropractic management for~     treatment of chronic lower back pain in older adults.~   "
235302|NCT00475774|"~     The primary purpose of the study is to examine the effect of body fat distribution on the~     physiological response to a dietary fat intervention. Physiological response will be~     evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance).~      Secondary objectives are targeted protein production (apoB and adiponectin). Examination of~     the effect of chain length of the dietary fatty acids on fat tissue characteristics and the~     effect of chain length on satiety, will be studied as well.~   "
235303|NCT00475761|"~     Background:~      Women whose mammograms show a lot of dense areas are more likely to develop breast cancer and~     to have cancers that are missed by mammograms.~      It is unclear why some factors lead to having dense breasts and why having dense breasts~     increases the risk of developing breast cancer.~      Objectives:~      To determine why some women s breasts look dense on mammograms.~      To determine what types of cells and tissues make up dense areas of breasts and why these~     tissues may be more likely to become cancerous.~      Eligibility:~      Women between 40 and 65 years of age who have not had breast cancer or received medicines or~     radiation for any type of cancer and who are scheduled to undergo a breast biopsy.~      Design:~      This study is conducted at the University of Vermont, in collaboration with the NCI.~      Participants undergo the following:~        -  Review of their medical records collected over the last 2 years by the Vermont~          Mammography Registry.~        -  Participation in a short telephone interview.~        -  Height and weight measurement.~        -  Testing of biopsy tissue collected for diagnosis or treatment.~        -  Future contacts regarding health status for up to 10 years, including review of~          additional mammograms, removed tissues, questionnaires and medical records collected by~          the Vermont Mammography Registry during the 10-year study.~      Participants may also undergo the following optional procedures:~        -  Provide a mouthwash sample for genetic testing.~        -  Provide a blood sample to test for markers of dense mammograms or breast cancer.~   "
235304|NCT00475748|"~     ABSTRACT/EXECUTIVE SUMMARY BACKGROUND, SIGNIFICANCE & RATIONALE: Between 10-20% of the more~     than 6000 cases of spinal cord injury seen annually in the North America have the clinical~     pattern of traumatic central cord syndrome (TCCS). These patients are usually older, most~     likely have sustained a fall, and have incomplete spinal cord injury characterized by~     dysesthetic and weak upper extremities. CT scan of the cervical spine in patients with TCCS~     often shows disc/osteophytes complex superimposed on degenerative or congenital spinal~     stenosis and MRI reveals signal changes at one or multiple skeletal segments. A minority of~     these patients suffer from fracture/subluxations, however, this group of patients are younger~     and have been involved in a more dynamic trauma. Since 1951, when Schneider et al reported~     this syndrome, controversy has dominated its surgical management. The current Guidelines for~     the Management of Acute Cervical Spine and Spinal Cord Injuries recommendations are only at~     the level of options, since prospective outcome data are unavailable.~      HYPOTHESIS: in acute traumatic central cord syndrome, surgical decompression of the spinal~     cord within five days will result in more rapid motor recovery, than decompression 6 weeks~     following injury. To test this hypothesis, we will pursue the following specific aims:~      SPECIFIC AIM I: To compare American Spinal Injury Association (ASIA) Motor Scores after three~     months post injury in patients with central cord syndrome operated on within five days of~     injury to a similar group of patients operated on 6 weeks following injury.~      SPECIFIC AIM II: To compare functional outcome, health related quality of life and~     posttraumatic syrinx size in patients with traumatic central cord syndrome operated on within~     five days to a similar group of patients operated on 6 weeks following injury.~      DESIGN: Single center prospective randomized study. PROCEDURE: In a two-year period thirty~     patients with traumatic central cord syndrome and cord compression (15 patients in each~     group) will be randomized to undergo surgical decompression either within the first five days~     or at 6 weeks following spinal cord injury. ASIA motor, functional recovery and health~     related quality of life between the two groups will be compared at admission, discharge from~     rehab facility 3 months and 12 months after surgery.~   "
235305|NCT00475735|"~     The purpose of this study is to investigate the safety and efficacy of an investigational~     treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.~   "
235306|NCT00475722|"~     The purpose of this study is to help develop diets for colon cancer prevention. This study~     will compare the Mediterranean diet to the Healthy People 2010 diet in 120 subjects with~     increased risk for colorectal cancer.~   "
235307|NCT00475709|"~     To confirm the clinical safety and effectiveness of the Trifecta valve.~   "
235380|NCT00474760|"~     This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently~     enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET~     and Askin's).~   "
235309|NCT00475683|"~     Mucositis consists of inflammation of the mucosal membrane and is a prominent cause of~     patient discomfort during cancer therapy. In children receiving chemotherapy, the incidence~     of oral mucositis is reported to be between 40%-70%. Curcumin, a commonly-used spice in India~     and Southeast Asia, was shown in animal models to prevent chemotherapy and radiotherapy~     induced mucositis. We hypothesize that curcumin may prevent oral mucosal injury and reduce~     the severity of oral mucositis in children receiving chemotherapy. Thus, the aim of this~     study is to determine whether in children undergoing doxorubicin-containing chemotherapy,~     does supplementation of curcumin, when compared to placebo, decrease oral mucositis both by~     objective (mucositis scales) and subjective (pain scale) measurements. Effective prevention~     and reduction of mucosal injury may significantly improve the care we provide to children~     undergoing therapy for cancer.~   "
235310|NCT00475670|"~     This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without~     a taxane for the first line treatment of metastatic breast cancer in women who have relapsed~     at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for~     HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading~     dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by~     3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or~     paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study~     treatment is until disease progression, and the target sample size is <100 individuals.~   "
235311|NCT00475657|"~     The purpose of this study is to determine if cisplatin and pemetrexed are effective in the~     treatment of patients with Small Cell Lung Cancer, extended disease.~   "
235312|NCT00475644|"~     To evaluate the antitumor activity, as measured by tumor response rate, of enzastaurin in~     patients with Follicular Lymphoma (FL).~   "
235313|NCT00475631|"~     Purpose:~      The purpose of the study is to complete a cost analysis of the different methods used for~     clubfoot treatment.~      Objectives:~      Short-term objective: To explore the experience of British Columbia Children's Hospital~     (BCCH) with costs and outcomes related to the various forms of clubfoot management since 1984~     to present.~      Long-term objective: To use the information gathered in this project and apply it to future~     studies in the clubfoot research program and to do a complete cost-benefit analysis.~      Hypothesis: The hypothesis of the study is that the BCCH clubfoot treatment program has~     better outcomes in terms of reduced financial costs than the traditional surgical management.~   "
235314|NCT00475618|"~     The propouse of this study is to evaluate some combined preventive measures, of easy~     application in children under 6 years old as education, brush teeth, fluoride free tooth~     paste,fluoridated tooth paste, professional cleaning and fluoride varnish application, to~     determine between three groups of differents combined preventive measures, wich one is better~     in reduting dental caries appearance.~      Hypothesis:~        1. Ho: Dental caries reduction percentage is larger or equal in the group with only~          prevention education and Professional cleaning, than in the groups intercepted with~          fluoride varnish or fluoride toothpaste.~        2. Ha: Dental caries reduction percentage is less in the group with only prevention~          education and Professional cleaning, than in the groups intercepted with fluoride~          varnish or fluoride toothpaste.~   "
235315|NCT00475605|"~     This is an observational study to assess the long-term safety of Protopic® Ointment for the~     treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first~     tacrolimus ointment exposure are eligible to participate. No drug is distributed during this~     observational trial.~   "
235316|NCT00475592|"~     The purpose of this study is to develop a grading system for esophageal varices using capsule~     endoscopy in patients with portal hypertension and cirrhosis.~   "
235317|NCT00475579|"~     Patients mechanically ventilated using an endotracheal tube with a subglottic secretion~     drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than~     using a conventional endotracheal tube~   "
235318|NCT00475566|"~     The purpose of this first-in-man study is to evaluate the safety and performance of the~     Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with~     atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal~     lesions.~      Abbott Vascular is ceasing data analysis of the STRIDES Clinical Trial after 2 years. The~     decision to discontinue the study is not related to any safety concern. The rationale for~     this proposal is based on the following considerations:~      The performance of DYNALINK-E from STRIDES shows no device- or procedure-related deaths and~     no stent fractures, and the rate of additional revascularizations has been stable since~     approximately 14 months after the procedure.~      Evaluations of the bare metal nitinol DYNALINK and ABSOLUTE stents in the clinical literature~     show low rates of death, reintervention and stent fracture, which are consistent with STRIDES~     and demonstrate the safety of the nitinol stent platform of the DYNALINK-E.~      Long-term animal studies show no concerns with the drug or polymer coating of DYNALINK-E -~     everolimus tissue concentration drops below the quantifiable limit by approximately 17 months~     after implant, and vascular response to the coating is normal with widely patent lumens and~     struts incorporated into vessel tissue.~      The safety and performance of the DYNALINK-E has been substantiated by its clinical and~     pre-clinical data, and by the clinical data of similar products. Given the demonstrated~     mechanical integrity of the stent along with the evidence of a healthy long-term vascular~     response, there is a reasonable expectation of continued low event rates.~   "
235319|NCT00475553|"~     The purpose of this research study is to evaluate the best way to manage breakthrough~     spotting and bleeding during an extended use regimen of NuvaRing®. Ease of use and~     acceptability of a flexible regimen of NuvaRing® will also be evaluated. A comparison of~     cyclic mood symptoms, pelvic pain, and headaches will be made between a standard 21/7 regimen~     and an extended regimen.~   "
235320|NCT00475540|"~     The primary aim of this double-blind, randomized clinical trial (RCT) is to test the~     hypothesis that the addition of a standardized technique of interpositional synthetic~     polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery~     for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without~     mesh.~   "
235537|NCT00472628|"~     The purpose of the study is to procure blood samples from patients ≥18 years of age who~     present to the Emergency Department (ED) with at least two of the diagnostic criteria for~     sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis~     Panel and other biomarkers.~   "
235321|NCT00475527|"~     Iron deficiency anemia (IDA) is a major health problem in children, effecting up to 20% of~     young children. Helicobacter pylori (HP) infection is also reported to be prevalent in~     children. Several large epidemiologic studies support an association between HP infection and~     lower iron stores. Other small studies suggest improvement in anemia following HP treatment.~      We assume that the prevalence of HP infection in Israeli children diagnosed with IDA is high~     and that that adding therapy for HP in those children will improve the response to iron~     deficiency.~   "
235322|NCT00475514|"~     Although the predictability of an MRM headache attack lends itself to preventative treatment,~     there are currently no drugs specifically indicated for the prevention of MM. Such~     preventative therapies might be administered either short term (during the time around the~     period otherwise known as the peri-menstrual period or PMP) or continuously throughout the~     menstrual cycle.~      Frovatriptan has been developed for the management of migraine and is already licensed for~     use as an acute treatment for this condition. Previous well controlled clinical trials have~     highlighted the potential of frovatriptan as a short-term preventative medication for MM.~     This clinical trial was meant to further explore this indication for frovatriptan in an~     expanded population.~   "
235323|NCT00475501|"~     The purpose of this study is to determine whether a higher-than-replacement dose of~     testosterone and finasteride can be combined to safely increase muscle strength in older men~     who have a low blood concentration of testosterone.~   "
235324|NCT00475488|"~     Coronary Artery Bypass Graft (CABG)Surgery is commonly used to treat patients with coronary~     artery disease (atherosclerosis) for the relief of angina (chest pain) and improve heart~     muscle function.~      Healthy veins or arteries, referred to as 'conduits' from elsewhere in the patient's body,~     are grafted (attached) from the aorta to the coronary arteries, bypassing (via new routes)~     coronary artery narrowings caused by atherosclerosis (hardening of the arteries) and thereby~     improving the blood supply to the myocardium (heart muscle).~      Over the years, a range of different veins and arteries from around the body have been used~     to bypass diseased coronary arteries. Typically, internal thoracic arteries from behind the~     breastbone and the saphenous veins from the legs are used for bypass. More recently, radial~     arteries from the forearm have also been used to bypass coronary arteries that are diseased~     (atherosclerotic). There is strong evidence to indicate that the left internal thoracic~     artery stays open the longest (i.e. has the highest patency) and achieves the best health~     outcomes. As a result, most cardiac surgeons use the left internal thoracic artery as their~     first choice of conduit (vessel used to bypass the blocked artery). However, many patients~     require multiple grafts and there is little evidence as to which grafts are the best conduits~     to use.~      It has been suggested that the radial arteries might function better than saphenous veins as~     conduits. The Radial Artery Patency and Clinical Outcomes Trial(RAPCO) aims to compare~     patency of the radial arteries with the right internal thoracic artery and also with the~     saphenous vein.~   "
235325|NCT00475475|"~     The purpose of this study is to investigate whether beverages sweetened with fructose promote~     overconsumption of calories as compared to beverages sweetened with glucose or a non-caloric~     sweetener.~   "
235326|NCT00475462|"~     The purpose of this study to evaluate the effectiveness of metoprolol versus conventional~     treatment in the prevention of syncope recurrence in children and adolescents.~   "
235327|NCT00475449|"~     This study compared two different methods of restoring blood flow to the heart when there has~     been a narrowing or blockage in the blood vessels that supply the heart. Currently there are~     two different ways of restoring blood flow. One is heart surgery where a surgeon operates~     directly on the heart, through an incision in the breast bone (sternum) and takes segments of~     the patient’s (non-essential) veins or arteries and then uses these to bypass blocked or~     narrowed segments in the coronary arteries. This way additional blood can be “piped” into the~     heart muscle wall. The second method is coronary angioplasty with stent implantation.~     Coronary angioplasty is a non-surgical method performed under a local anaesthetic. During~     angioplasty a special balloon is advanced to the site of a coronary narrowing, then inflated~     to make it expand and this action removes the narrowing. This is a more simple and less~     invasive than surgery but its value has been limited by a tendency for narrowings to~     reoccur(restenosis) in the six months following the treatment. When this happens a repeat~     procedure is often performed. To reduce the incidence of restenosis coronary stents are~     implanted. These are tubular metal scaffold devices that are placed inside a coronary artery~     at the site of a previous narrowing to help keep the artery open. These devices are usually~     delivered on an angioplasty balloon and expanded into place.~      Both treatments are equally effective at preventing death and subsequent myocardial~     infarction and most doctors are happy to recommend either option. Angioplasty offers a more~     simple initial procedure but with a chance of needing a repeat performance. Bypass surgery~     represents a more significant initial undertaking with a longer recovery and convalescent~     period but in most cases, provides good relief of symptoms. Patient preference plays an~     important part in the decision process.~      Bypass grafting is currently the therapy most frequently performed world-wide. Angioplasty~     has a number of important advantages but the need for repeat procedures currently limits its~     appeal.~      Since these trials were performed there have been important advances in angioplasty~     techniques. Prominent amongst these has been the development and use of Coronary Stents which~     has been shown (in clinical trials) to reduce the need for repeat procedures after an initial~     angioplasty. Consequently stent implantation is now in routine use world wide.~      If angioplasty is performed with coronary stent implantation then this may reduce the need~     for repeat procedures and address the principal factor currently limiting the value of this~     approach. If the results were found to be as good as with bypass grafting then patients could~     benefit from a shorter hospital stay, a less traumatic operation and a shorter recovery~     period. We therefore wish to compare the outcomes in patients treated with a) bypass grafting~     or b) angioplasty with coronary stent implantation.~   "
235328|NCT00475436|"~     GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being~     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long~     duration of action of GSK573719 when administered via inhalation in animal models supports~     the potential for use as a once-daily bronchodilator for COPD~   "
235329|NCT00475423|"~     This single arm study will evaluate the efficacy and safety of MabThera monotherapy in~     patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP).~     Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated~     time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
235330|NCT00475410|"~     Anal fistula is defined as an abnormal communication between the anal canal and the perianal~     skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This~     study will test the safety and efficacy of ASCs (adipose stem cells) in the treatment of~     patients without Crohn´s disease.~   "
235331|NCT00475397|"~     Study F1J-MC-SBBU will examine the effect of duloxetine treatment in women with SUI. The~     inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a~     clinical diagnosis of SUI.~   "
235381|NCT00474747|"~     The goal of this clinical research study is to find out the best dose of cyclophosphamide~     that can be given with fludarabine, antithymocyte globulin (ATG), and low-dose total body~     irradiation (TBI) to patients before a bone marrow transplant to decrease the risks related~     to the transplant while not decreasing the effectiveness of the transplant from an unrelated~     donor.~   "
235332|NCT00475384|"~     Objectives:~      Primary:~        1. To establish the feasibility of delayed infusion of ex vivo anergized donor peripheral~          blood mononuclear cells (PBMC) after CD34 selected megadose haploidentical hematopoietic~          stem cell transplant (HSCT) Determine the feasibility of collecting parental allogeneic~          stimulator cells to induce anergy to the non-shared donor:recipient haplotype Determine~          the feasibility of collecting donor PBMC as a source of T cells for ex vivo anergization~          Determine the number of transplanted individuals who meet the criteria for proceeding to~          delayed infusion of ex vivo anergized donor PBMC~        2. To establish the safety of delayed infusion of ex vivo anergized donor PBMC by~          establishing the maximal number of donor T cells that can be infused without~          unacceptable graft-versus-host disease (GVHD)~      Secondary:~        1. To evaluate in vitro the induction and specificity of alloantigen hyporesponsiveness in~          donor PBMC after ex vivo anergization~        2. To assess in vitro the function of immune cells engrafted in the recipient To assess in~          vitro whether alloantigen hyporesponsive donor T cells are present in the recipient~          after HSCT To develop preliminary in vitro data on the extent of pathogen-specific~          immunity and its rate of recovery To describe the patterns of opportunistic infections~          in patients so treated~   "
235333|NCT00475371|"~     26 subjects will be enrolled into 5 different dose groups. The trial will consist of a~     screening, a dosing and a follow-up visit.~      Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given~     at 5 dose levels.~   "
235334|NCT00475358|"~     Study F1J-MC-SBBT will examine the effect of duloxetine treatment in women with SUI. The~     inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a~     clinical diagnosis of SUI.~   "
235335|NCT00475345|"~     The purpose of this study is to determine whether or not bedtime snacks are necessary to~     prevent overnight low blood glucose reactions (nocturnal hypoglycemia) in adults with type 1~     diabetes who are using intensive insulin therapies, either multiple injections of insulin or~     insulin pump.~      We hypothesize that a bedtime snack is not necessary if the bedtime insulin is very well~     adjusted and delivered, especially by use of insulin pump which is considered the gold~     standard for overnight blood glucose control.~   "
235336|NCT00475332|"~     The purpose of this study is to determine the feasibility of treating relapsed follicular~     lymphoma with a combination of Bexxar and External Beam Radiotherapy (EBRT). Patients will~     receive EBRT (20 Gy in 10 fractions) followed by Bexxar.~   "
235337|NCT00475319|"~     The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye~     patients~   "
235338|NCT00475306|"~     Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea,~     vomiting, and migraine headaches in Emergency Departments. However, little research has~     focused on the optimal dose of metoclopramide for treatment of nausea in the emergency~     department. We propose a randomized, double-blind, placebo controlled trial to investigate~     the optimal dose of metoclopramide for treatment of nausea.~   "
235339|NCT00475293|"~     The purpose of this study is to assess the objective response rate (ORR) when panitumumab is~     administered in combination with irinotecan as 2nd-line therapy in subjects with previously~     treated metastatic colorectal cancer (mCRC).~   "
235340|NCT00475280|"~     This study aims at considering clinical heterogeneity of patients based on a geriatric~     assessment without taking into account the real age of the subject. This will allow~     physicians to adapt therapy according to three different groups of patients: frail, fit and~     intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the~     different categories of patients.~   "
235341|NCT00475267|"~     The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta~     valve.~   "
235342|NCT00475254|"~     Retinitis pigmentosa (RP) patients experience a slowly progressive, unpredictable loss of~     vision which eventually leads to bare or no light perception, posing a continuous threat to~     patients' independence. Negative psychological states such as distress, sleepiness, anxiety~     and depression are common in RP patients due to the nature of this chronic, disabling~     disease. Psychophysical vision measures are more variable in legally blind RP subjects than~     in normally sighted individuals, and RP patients indicate that variations in vision are often~     related to stress. The primary goal of this research is to examine the vision fluctuations~     within and between days among RP patients using vision tests self-administered by patients~     through their home computers, and determine associations with factors such as perceived~     stress, mood states, sleepiness, or light exposure. The administration of questionnaires will~     allow us to gain some insight into which underlying psychological factors impact certain~     vision measures, allowing the design of future interventional research to attempt to reduce~     such factors. The aims of many future treatment clinical trials for RP will be to improve~     vision and/or reduce the rate of vision loss; thus the sources that lead to increased~     variability of vision need to be identified and alleviated to enable precise evaluation of~     interventions and improve patients' quality of life.~   "
235343|NCT00475241|"~     The goals of the proposed research are to produce preliminary evidence of PE with OEF/OIF~     veterans with PTSD and to examine cognitive, psychophysiological, and neuroendocrine~     mechanisms of change in PTSD treatment. In brief, 36 OEF/OIF veterans with chronic PTSD or~     PTSS of at least 3 months duration will be randomly assigned to 15 sessions of either PE or~     TAU (see below for descriptions of the interventions). All veterans will receive~     psychobiological assessments at pre treatment, mid treatment, post treatment, 3 months, and 6~     months follow-up. Each of these assessments will cover in 2 sessions on separate days and~     will include interview and self-report of symptoms (i.e., PTSD, depression, and general~     anxiety severity), self-report of PTSD-related cognitions, psychophysiological (i.e., heart~     rate, skin conductance, respiration, and end-tidal CO2) assessment during neutral and trauma~     scripts, and assessment of salivary cortisol during neutral and trauma scripts. Also, on the~     morning prior to each laboratory assessment, patients will collect salivary cortisol at the~     moment of waking and 30 and 45 minutes post-walking. In addition to these assessments,~     patients assigned to PE will collect salivary cortisol during three imaginal exposure~     sessions (sessions 3, 9, and 15).~   "
235414|NCT00474305|"~     This study will examine whether the use of a Virtual World will be effective in helping treat~     Posttraumatic Stress Disorder (PTSD). This is a pilot study, with five victims of bus~     bombings who have developed PTSD. The study will examine pre- and post-treatment levels of~     PTSD, anxiety, depression and day-to-day functioning.~   "
235344|NCT00475228|"~     This study is a randomized controlled trial of insertion of the levonorgestrel-releasing~     intrauterine device (LNG-IUD) immediately following dilation & evacuation (D&E) compared to~     delayed insertion 3-6 weeks post-D&E. Eighty-eight women undergoing D&E between 15 0/7 and 23~     6/7 weeks gestation will be enrolled at Magee-Womens Hospital, Pittsburgh, PA. The primary~     outcome is LNG-IUD usage six months following enrollment. We hypothesize that more women~     receiving immediate insertion will be using the LNG-IUD 6 months after the D&E procedure than~     women receiving delayed insertion. Secondary outcomes include the proportion receiving an~     IUD, continuation rate, complication rates, subject satisfaction, and quality of life. The~     utility of ultrasonography in predicting expulsion will also be examined. Anticipated~     problems include poor subject follow-up and coordinating the intra-operative study~     procedures.~   "
235345|NCT00475215|"~     The purpose of the trial is to research the safety and to show faster recovery after~     administration of 2.0 mg/kg or 4.0 mg/kg Org 25969 (sugammadex) given as a reversal agent for~     Zemuron® in subjects diagnosed with or having a history of pulmonary disease.~   "
235346|NCT00475202|"~     Diabetic foot ulcers are a major cause of morbidity and mortality, accounting for~     approximately two-thirds of all non-traumatic amputations performed in the United States. The~     cost of foot ulcers in diabetic patients averages almost $28,000 for the two years after~     diagnosis of the ulcer. Hyperbaric oxygen (HBO) serves as primary or adjunctive therapy for a~     diverse range of medical conditions. HBO also has been used as an adjunct to antibiotics,~     debridement, and revascularization in the therapy of chronic, nonhealing wounds associated~     with diabetes or non-diabetic vascular insufficiency.~      The aim of the study is to assess whether hyperoxia induced angiogenesis in diabetic patients~     with foot ulcers.~   "
235347|NCT00475189|"~     The purpose of this research study is to assess hormone withdrawal symptoms in women while~     taking an oral contraceptive in the novel 24/4 (24 days of real pills) manner in comparison~     to taking pills in the standard 21/7 (21 real pills) manner.~      It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms~     compared to the standard 21/7 regimen.~      It is further hypothesized that women using the 24/4 regimen will report greater satisfaction~     scores.~   "
235348|NCT00475176|"~     This study will examine the effectiveness of S-adenosyl methionine (SAMe) in combination with~     peginterferon and ribavirin for treating hepatitis C virus. One out of three patients with~     hepatitis C develops cirrhosis of the liver, which can lead to liver failure or liver cancer.~     SAMe is a nutritional supplement that is made naturally in all cells of the body and acts to~     improve how the body handles stress. In laboratory experiments with liver cells, SAMe~     decreases the injury caused by liver toxins and improves the ability of interferon to block~     hepatitis C virus.~      Patients 18 years of age and older with hepatitis C infection who did not respond~     successfully to prior treatment with interferon and ribavirin or peginterferon and ribavirin~     may be eligible for this study.~      Participants receive the following treatment:~        -  Peginterferon (given by injection) and ribavirin (taken by mouth) for 2 weeks~        -  Washout period (no medications) for 4 weeks~        -  SAMe (taken by mouth) for 2 weeks~        -  Peginterferon, ribavirin and SAMe for 12-48 weeks, depending on patient response to~          treatment.~      Participants have a thorough physical evaluation before beginning treatment and again at the~     study's end. After starting treatment, patients return for clinic visits and blood tests~     weekly for the first several weeks, then less frequently (at 2-week, then 4-week and 8-week~     intervals until up to 72 weeks) to monitor symptoms, drug side effects, hepatitis C virus~     levels, liver enzyme levels and immune responses to hepatitis C.~   "
235349|NCT00475163|"~     Assesing the impact of mentoring on the lifestyle choices of adolescents who are overweight~   "
235350|NCT00475150|"~     This phase II trial is studying how well cediranib maleate works in treating patients with~     relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic~     syndrome. Cediranib maleate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the cancer.~   "
235351|NCT00475137|"~     Depression is a medical condition characterized by feeling sad even when good things happen,~     having low energy and motivation, and sometimes even experiencing suicidal thoughts. Bipolar~     II Disorder is an illness in which periods of depression alternate with periods of abnormally~     elevated mood, energy and activity, referred to as hypomania. After Major Depressive~     Disorder, Bipolar II Disorder is the most common cause of depression. Unfortunately,~     antidepressant medications, used alone, do not work as well in treating Bipolar depression as~     they do in treating other kinds of depression. Lamotrigine is a medication which studies show~     is effective in treating Bipolar depression. The investigators will determine if lamotrigine~     works best to treat Bipolar II depression if it is used alone, or if it is taken with an~     antidepressant. In the first part of our investigation, people with Bipolar II depression who~     have not responded to an antidepressant will either add lamotrigine to their antidepressant,~     or will stop the antidepressant and take lamotrigine alone. They will see the study doctor~     for 6 visits over 8 weeks, and will answer questions about their depressive symptoms and~     their overall health. The purpose of this study phase is to determine which treatment works~     best to treat active Bipolar depression. In the second part of the study, people who have~     responded to their assigned treatment may continue to receive it for another 44 weeks. They~     will see the study doctor monthly, and will answer similar questions about their health.~     Participants will also receive a physical examination and get a blood test three times during~     the study. The purpose of the second phase is to ascertain which treatment is best at~     preventing relapses of depression. The investigators hypothesize that people who take~     Lamotrigine plus an antidepressant will recover from their depression more completely, have a~     longer period of wellness, and have better quality of life compared to those taking~     Lamotrigine alone.~   "
235352|NCT00475124|"~     Patients with implanted pacemakers are currently seen by their cardiologists every 6-12~     months. Shorter follow-up intervals are generally seen as excessive workload for the~     physician, with little benefit for the patient. Longer intervals are seen as too dangerous~     concerning device integrity and safety. This scheme still results in a large number of~     follow-up visits with little or no important changes in pacemaker therapy.~      Our clinical trial investigates efficacy and safety of the Home Monitoring technology for~     increasing the flexibility in pacemaker follow-up. Home Monitoring technology allows~     automatic transmission via mobile phone links of relevant data from the implanted pacemaker~     to a service center. The patient's physician can access the data via a password-protected~     internet site. The regular Home Monitoring data analyses entirely replace clinical routine~     visits (virtual clinic). Follow-up visits are scheduled according to the results of the~     Home Monitoring data analyses.~      The primary endpoint of the study is to compare the total workload for pacemaker patient care~     in the virtual clinic with that of standard follow-up scheme with regularly scheduled~     clinical visits.~   "
235353|NCT00475111|"~     Rheumatoid arthritis (RA) is an autoimmune disease that causes long-term inflammation of the~     joints and occasionally, other body tissues. The purpose of this study is to evaluate two~     different types of cognitive behavioral therapy (CBT) in reducing RA disease activity and~     improving mental health of adults with RA.~   "
235354|NCT00475098|"~     Experiments suggest that low molecular weight heparin (LMWH) inhibits tumor growth and~     metastasis. Studies in humans suggest that LMWH is associated with a higher survival in~     patients with cancer related thrombosis. Two recent studies suggest that LMWH may increase~     the survival of patients with cancer who do not have an associated thrombosis. The purpose of~     the study is to assess the effect of LMWH on the overall survival of patients with localized~     non-small cell lung cancer after complete surgical resection.~   "
235355|NCT00475085|"~     RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine,~     aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which~     combination of antiemetic drugs is more effective in preventing nausea caused by~     chemotherapy.~      PURPOSE: This randomized phase III trial is comparing different combinations of granisetron,~     dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in~     preventing nausea in patients undergoing chemotherapy for breast cancer.~   "
235356|NCT00475072|"~     This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients~     with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms~     s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks.~     Following treatment there will be a 24 week period of treatment-free follow-up. The~     anticipated time on study treatment is 3-12 months, and the target sample size is <100~     individuals.~   "
235357|NCT00475059|"~     Among the different creatinine-based GFR predicting equations, the MDRD equation gives the~     best prediction in renal transplantation but does not provide the level of accuracy usually~     seen in renal patients with native kidneys.~      Blocking the tubular secretion of creatinine with an oral administration of cimetidine is~     likely to make creatinine a more accurate marker of GFR.~      We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal~     transplant patients by incorporating into the equation a cimetidine-corrected serum~     creatinine value.~   "
235358|NCT00475046|"~     Background: Pregnancy was found to be a significant triggering factor for smoking cessation~     and the reduction of nicotine consumption, but 50 - 70 % of mothers who stopped smoking~     during pregnancy resume tobacco smoking after delivery. One main reason for the high relapse~     rates is that many women are solely motivated to quit smoking for the baby’s sake. After~     birth, the external reason for having quit has vanished and no other internal or external~     motives exist for many women to maintain being smoke-free. Therefore, under consideration of~     the Transtheoretical Model approach, relapse prevention and smoking cessation interventions~     have to focus on two aspects: (1) on a specific reformulation of the stages of change for~     women who show a temporarily and externally motivated change in smoking behavior during~     pregnancy, (2) on intervention strategies taking advantage of the behavioral change already~     done and evoking the cognitive and behavioral processes necessary for maintenance. In Germany~     pediatricians are in a unique position to address this issue because nearly every mother~     attends a pediatric practice for preventive examination of the newborn. Objectives: To adapt~     and implement motivational enhancement interventions in pediatric practices. The aim is to~     examine the effectiveness of a modified stage-matched motivational enhancement intervention~     added to the common pediatricians´ advice. A second aim is the reformulation and reassessment~     of the stages of change for women who have recently given birth. Methods: The study design is~     a randomized controlled trial. Mothers smoking at the beginning of the pregnancy and~     attending pediatric practices in West Pomerania will be assigned to an intervention group (n~     = 330) and referred to a liaisonal service providing a face-to-face motivational enhancement~     intervention followed by telephone brush-up sessions. A control group (n = 330) receives~     treatment from the pediatrician as usual at the preventive examination. The core outcome~     measures comprise abstinence, and progress in the stages of change 6, 12, 18 and 24 months~     after baseline. Expected impact: Data will evaluate the usefulness of intervening in~     pediatric offices and will provide information about a tailored intervention program. The~     processes of change favorable for intervention in this population will be identified. This is~     of great relevance with regard to the prevention of health damage for mother and child.~     Furthermore, results will serve as a basis for guidelines for pediatricians to deal with~     women smoking postpartum. Relationship to the objective of the collaboration: As in the other~     studies, this study provides empirical data of a new proactive approach to reach underserved~     populations in the addiction field. This project will add knowledge on how to intervene~     (motivational enhancement vs. usual advice), on setting-specific advantages of pediatric~     offices and on the impact of the chosen intervention strategy.~   "
235359|NCT00475033|"~     The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of~     13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric~     vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and~     Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with~     13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune~     responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and~     immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.~   "
235360|NCT00475020|"~     The goal of this clinical research study is to learn if using a combination of fludarabine,~     busulfan, and antithymocyte globulin (ATG) can help to control myelofibrosis or~     myelodysplastic syndrome in patients receiving a bone marrow or blood stem cell transplant.~     The safety of these drugs will also be studied.~   "
235361|NCT00475007|"~     This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis~     of emphysema. The objective of the trial is to determine the safety and effectiveness of the~     IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to~     achieve improvement in disease-related health status.~   "
235362|NCT00474994|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     metastatic, locally advanced, or locally recurrent sarcomas.~   "
235363|NCT00474981|"~     This study is a cluster-randomized trial being conducted in the state of Haryana in North~     India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been~     randomized to intervention or comparison areas. In the intervention areas, all physicians,~     health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an~     approximate population of 30,000.~      The IMNCI intervention includes three main components:~        1. improvement in the case management skills of health staff~        2. improvement in the overall health system to support its performance, and~        3. improvement in family and community health care practices which include:~             -  prevention and management of hypothermia~             -  early initiation of breastfeeding and exclusive breastfeeding~             -  community-based care of low birth weight infants~             -  improved care-seeking for neonatal infections~      The primary outcome measures of the study are neonatal and infant mortality. The study will~     also collect information on cause-specific neonatal mortality, ascertained using a~     standardized previously validated verbal autopsy instrument administered by trained, skilled~     health workers. All the other outcomes (including initiation of breastfeeding within 1 hour~     of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be~     sick by caregivers who sought care) are secondary outcomes.~      The effectiveness of this comprehensive intervention will be measured by comparing the~     primary and secondary outcome measures in the intervention and comparison clusters,~     controlling for any baseline differences such as the predefined outcomes and/or socioeconomic~     status and demography.~      The project will serve as a guide to the Government of India of how to best implement the~     IMNCI strategy and measure its impact.~   "
235364|NCT00474968|"~     A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared~     to the FDA-approved spatula/cytobrush when used as the cell collection device in screening~     for cervical cancer.~      The InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector~   "
235365|NCT00474955|"~     This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic~     hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will~     receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular~     filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following~     48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
235366|NCT00474942|"~     Apparent mineralocorticoid excess (AME) is a rare inherited disease that can cause severe~     high blood pressure and low blood potassium in children and adults. It is caused by abnormal~     hormone metabolism and can be fatal. This study will focus on the genetic basis, natural~     history, disease progression, and survival of people with AME.~   "
235367|NCT00474929|"~     RATIONALE: Sorafenib and everolimus may stop the growth of cancer cells by blocking blood~     flow to the cancer and by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib and~     everolimus and to see how well they work in treating patients with relapsed or refractory~     non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.~   "
235368|NCT00474916|"~     The purpose of this study is to collect beginning information on whether intravenous (IV)~     administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients~     with cancer.~   "
235369|NCT00474903|"~     This randomized phase II trial is studying the effect of esomeprazole magnesium and aspirin~     on tissue PGE2 levels compared with esomeprazole and placebo. This type of chemoprevention~     treatment investigates the use of certain drugs to assess whether they assist in the~     prevention of cancer. The use of esomeprazole magnesium with or without aspirin may help~     prevent esophageal cancer in patients with Barrett esophagus.~   "
235370|NCT00474890|"~     A previous study has shown very clearly that the treatment with the combination of cetirizine~     and pseudoephedrine is superior to the treatment with the single agents regarding the~     reduction of symptoms in patients with allergic rhinitis. These data, obtained after~     controlled pollen exposure out of the pollen season, showed highly reproducible individual~     responses prior to dosing. It is not clear, however, whether the same results can be obtained~     during the pollen season, when additional natural pollen exposure may influence the~     variability of the individual reactions.~   "
235371|NCT00474877|"~     This study tested the hypothesis that there would be a difference in the 12 month progression~     of structural hand impairment and hand function between a group of patients with early RA who~     received static resting splints and those that did not.~   "
235372|NCT00474864|"~     The rationale for this study is to determine whether GW856553 (7.5mg BD for 28 days) has an~     effect on endothelial function in dyslipidaemic subjects as assessed by venous occlusion~     plethysmography using brachial artery acetylcholine infusion. This will establish consistency~     with preclinical findings, as well as confirm a physiologic human response at the current~     safe maximal dose. Safety (specifically serum liver function testing) and tolerability will~     also be evaluated in this trial.~   "
235373|NCT00474851|"~     The purpose of this study is to determine whether a regimen of norethindrone acetate +~     placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal~     health and quality of life in adolescents treated with a GnRH agonist for endometriosis.~   "
235374|NCT00474838|"~     This randomized controlled prospective study aims to evaluate the efficacy of intensive~     insulin therapy for long term glycemic control and improvement or preservation of beta cell~     function in newly diagnosed type 2 diabetes patients.~   "
235375|NCT00474825|"~     This research is being done because we do not know the best treatment for advanced Squamous~     Cell Carcinoma of the Head and Neck. These cancers have been treated with a combination of~     surgery, radiation and chemotherapy in varying combination. When the tumor is inoperable,~     radiation therapy is used with or without chemotherapy in the hope of curing the tumor.~      Recently, it has become recognized as generalized knowledge that cancer cells are hypoxic~     (low oxygen concentration). Because of the low oxygen concentrations, many cancer treatments~     have not been successful. The theory behind this study is to give oxygen to patients prior to~     chemotherapy and radiation in hopes of generating greater results in killing cancer cells.~     The purpose of this study has two main objectives. The primary objective is to determine~     patient tolerance to each arm of the trial.~      The second objective is to determine the feasibility of treatment delivery and acute~     toxicities associated with each regimen.~      It is our intention to undertake a randomized and controlled trial should this Phase I trial~     prove successful in terms of patient tolerance.~   "
235376|NCT00474812|"~     Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. This phase II trial is studying how well dasatinib works in treating patients with~     metastatic pancreatic cancer.~   "
235377|NCT00474799|"~     The purpose of this study is to characterize the repeat dosing plasma profile, extent of~     accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and~     morphine-6-glucuronide during administration of MNS075 in two different, clinically-relevant~     dosing schedules.~   "
235378|NCT00474786|"~     This is an international, randomized, open-label, outpatient, multicenter study. Subjects~     will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by~     intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These~     investigational drugs will be administered in 6-week cycles for the duration of the study, up~     to 24 months. Subjects will be stratified by nephrectomy status, duration of response to~     sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC~     tumor histology.~   "
235379|NCT00474773|"~     This study will evaluate the benefits of continuing celecoxib through six weeks of total knee~     arthroplasty recovery. This is a randomized, double blind study with a group of approximately~     130 primary total knee patients. All patients will receive celecoxib throughout their~     hospitalization as per current minimally invasive total knee arthroplasty protocol. At the~     time of hospital discharge, participating patients will be randomly placed on either~     celecoxib 200mg twice a day or a placebo twice a day.~      This study will determine if the continued use of celecoxib for six weeks after total knee~     arthroplasty hospitalization will further decrease narcotic consumption, improve knee range~     of motion, improve ambulatory ability, and improve patient satisfaction over patients~     receiving celecoxib only during the acute hospitalization.~   "
235382|NCT00474734|"~     To diagnose hepatocellular carcinoma (HCC) and to determine the extent of the disease, a~     triphasic CT scan or a magnetic resonance imaging are required. The characterization of~     hepatic nodules is more difficult when the HCC lesions have a diameter of less than 2 cm.~      Since accuracy in the assessment of the number and the size of HCC nodules, as well as of the~     invasion of blood vessels is crucial to determine outcome after liver transplantation due to~     tumour recurrence, there is a need for techniques with a higher definition potential.~      As a consequence, to improve outcome and to optimize organ allocation, patients on the liver~     transplantation waiting list might benefit from intravascular ultrasound as an additional~     examination to complete the pre-transplant tumour staging process.~   "
235383|NCT00474721|"~     We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages~     5-18 years who came to the Pediatric Emergency Department with injuries to their arms or~     legs.~   "
235384|NCT00474708|"~     This study is an open-label, randomized, multi-center study conducted in a typical~     psychiatric outpatient practice in China. This study is intended to collect data on the~     efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional~     antidepressants in depressed patients that previously failed antidepressant treatment. This~     data will be used to guide psychiatrists on recommendations for clinic use.~   "
235385|NCT00474695|"~     The purpose of the study is to investigate whether the efficacy of Lucentis treatment for~     exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA~     polymorphisms~   "
235386|NCT00474682|"~     The aim of this study is to find out how well iron is absorbed when a newly developed form of~     ferric pyrophosphate is added to a commercial apple juice drink.~   "
235387|NCT00474669|"~     The primary objective is to assess the maximum tolerated dose of docetaxel administered~     intraperitoneally with heat at the time of second-look surgery in patients with stage II/III~     ovarian carcinoma.~   "
235388|NCT00474656|"~     Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of~     critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS~     kills 40-70% of affected patients. Patients with ARDS require life support in the form of a~     ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause~     further damage to the lungs. We are conducting a study comparing 2 methods to protect the~     lungs from further damage. One method uses standard mechanical ventilators and the other uses~     a new type of ventilator, called a high frequency oscillator. We propose to test whether this~     high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from~     12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study~     to test the feasibility of our study methods. If feasible, we plan to move on and conduct a~     large multinational study to definitively answer this question.~   "
235389|NCT00474643|"~     Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity~     and endocrine dysfunction that leads to cardiovascular disability and early death within the~     first 3 decades of life.To assess the significance of risk factors for future disabilities,~     carotid artery intima-media thickness (IMT) was measured and correlated with known~     atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index~     (BMI)-adjusted controls.~   "
235390|NCT00474630|"~     The purpose of this study is determine whether the combination of naltrexone SR and bupropion~     SR is safe and effective in treating obesity in subjects with type 2 diabetes.~   "
235391|NCT00474617|"~     The purpose of the trial is to compare the effectiveness, safety and pharmacokinetics of Org~     25969 in subjects 65 and over with subjects under 65.~   "
235392|NCT00474604|"~     RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also~     help doctors predict a patient's response to treatment.~      PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast~     cancer and in healthy participants.~   "
235393|NCT00474591|"~     (i) Main Research Question(s): What is the effect of fondaparinux on coronary graft patency,~     heart attack, stroke, and death in patients who have undergone coronary artery bypass~     grafting (CABG)? To reliably answer this question requires a large randomised trial. We~     propose a pilot study to demonstrate the feasibility of recruiting patients into this study~     and of performing CT angiograms to measure graft patency at 30 days.~      (ii) Why is this research important? Coronary artery bypass surgery has made a very important~     contribution to improving the health and survival of patients with advanced coronary artery~     disease but still has many problems. One in 10 patients experiences a heart attack at the~     time of surgery, 1 in 20 experiences a heart attack, stroke, or death during hospitalization,~     and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery. Fondaparinux, a~     relatively new anticoagulant drug, has been shown to significantly reduce cardiovascular~     events and death in patients who have suffered a recent heart attack. Compared to established~     anticoagulant therapies for acute myocardial infarction, fondaparinux has been shown to be~     more effective with similar or lower risks of bleeding.~      Fondaparinux, unlike the most commonly used anticoagulants, does not cause Heparin Induced~     Thrombocytopenia (HIT), a rare condition with extremely high morbidity and mortality.~      This drug has never been studied in CABG patients. Our pilot study will provide key~     information about feasibility that will help us to design and perform a large definitive~     study in the future.~      (iii) What is being studied? We will be looking at blood flow in bypass grafts, heart attack,~     stroke, venous thromboembolism and death. For safety we will be looking at bleeding,~     transfusion, and need for further surgery because of bleeding. We will also perform~     laboratory tests for HIT antibodies as their levels are prognostic for the development of HIT~     and are also related to morbidity and mortality. The incidence of actual HIT cases will also~     be recorded.~   "
235394|NCT00474565|"~     The present study relates to a new approach to coronary artery and coronary artery by-pass~     graft imaging, and more particularly to computed tomographic angiography following an aortic~     root injection of a low amount of contrast (up to 30 cc) via a percutaneously placed catheter~     (Vanguard DX, Medrad Inc.) positioned in the aortic root.~      The objective of the study is to show the feasibility of Coronary artery CTA using aortic~     root injection of contrast compared to the standard invasive cardiac catheterization.~   "
235395|NCT00474552|"~     Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315,~     an investigational drug, in healthy young adult and elderly subjects.~      Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses~     of SAM-315 in healthy young adult and elderly subjects.~   "
235396|NCT00474539|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given~     concomitantly with routine paediatric vaccinations in Spain.~   "
235397|NCT00474526|"~     This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY~     conjugate vaccine when administered with routine infant vaccinations to healthy infants.~   "
235398|NCT00474513|"~     GSK239512 is being developed for the treatment of symptoms of cognitive impairment in many~     diseases. GSK239512 is a drug that binds to the Histamine 3 receptor (a protein) in the brain~     (receptor occupancy). This study will use the technique of positron emission tomography (PET)~     as an imaging tool to highlight areas of the brain that GSK239512 has penetrated, and~     subsequently bound to receptors, after receiving an oral dose of the drug. It will also look~     at the rate the drug dissociates from the receptors in the brain. Results from the study will~     provide information on doses of the drug to be given in further studies.~   "
235399|NCT00474500|"~     The aim of this project is to measure the effect of Coca-Cola and Diet Coke, relative to~     mineral water, on non-haem iron absorption. The results from this study will quantify any~     enhancing effect of Coca-Cola or Diet Coke on non-haem iron absorption and will be of use to~     the Coca-Cola Company and the scientific and nutrition community in evaluating the~     nutritional value of these products.~   "
235400|NCT00474487|"~     This study will evaluate the safety and immune response of Novartis Meningococcal ACWY~     conjugate vaccine in healthy adolescents and adults.~   "
235401|NCT00474474|"~     There is a lack of evidence of the impact of the information provided in the introduction~     screen on the students diagnostic and therapeutic decisions. The reasoning pattern may also~     be altered if positive findings are provided to the student without an active request for it.~      The results will be of importance when virtual patients are used for assessing students.~   "
235402|NCT00474461|"~     The purpose of this study is to investigate the safety of intracoronary cardiac stem cells~     (CSCs) therapy in humans. Currently, there is no effective intervention to regenerate~     (regrow) dead heart muscle after a heart attack.~      The central hypothesis is that CSCs infused into nonviable myocardial segments will~     regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types.~     According to our hypothesis, CSC infusion regenerates myocardium with consequent improvement~     in contractile function of the heart and general clinical status.~   "
235403|NCT00474448|"~     The purpose of this study is to assess the health-related quality of life of subjects who~     have Hereditary Multiple Exostoses and to develop a disease specific quality of life survey.~     The investigators hypothesize that there are a wide range of quality of life experiences for~     patients with this syndrome.~   "
235404|NCT00474435|"~     In this pilot study the pharmacokinetics and safety of the antiretroviral combination of~     co-formulated emtricitabine/tenofovir/efavirenz will be studied in HIV-positive patients with~     pulmonary tuberculosis (TB) who are concomitantly treated with a standard rifampin-containing~     tuberculostatic regimen. It is expected that this antiretroviral combination causes minimal~     drug interactions with the rifampin-containing anti-tuberculosis medication.~   "
235405|NCT00474422|"~     Hypothesis: We hypothesized that providing in-hospital, supervised paraprofessional~     breastfeeding consultation during the hiatus between hospital discharge and the first~     postpartum WIC or pediatric visit would increase the rate of exclusive breastfeeding among~     low income Hispanic women at 1 month postpartum.~   "
235406|NCT00474409|"~     The purpose of this study is to determine the efficacy and safety of Betahistine Mesilate in~     the treatment of patients with vertigo caused by Cerebral Infarction in posterior~     circulation.~   "
235407|NCT00474396|"~     The purpose of the study is to determine whether low fat dairy diet reduces serum uric acid~     levels.~   "
235408|NCT00474383|"~     The purpose of this study is to assess the anti-tumor activities and safety of abiraterone~     acetate in participants with prostate cancer (a disease in which cells in the prostate gland~     [a gland in the male reproductive system found below the bladder and in front of the rectum]~     become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane~     (docetaxel)-based chemotherapy.~   "
235409|NCT00474370|"~     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government~     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5~     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells~     that fight infection). Previous smaller studies in HIV treatment-experienced patients, have~     shown that vicriviroc is safe and effective. The purpose of this study is to confirm the~     previous findings in a larger phase 3 study over a 48-week period, and show that when taken~     in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV~     (viral load) in the blood and that it is well tolerated.~   "
235410|NCT00474357|"~     This study will examine:~      1) The impact of psycho education group therapy sessions relating to beliefs/myths associated~     with bipolar affective disorder (BAD) on the emotional wellbeing, clinical course and~     cognition of individuals diagnosed with BAD 2) Will examine the existence of those same~     beliefs among the various caregivers - psychiatrists, general practitioners, social workers,~     and psychiatric nurses.~      The investigators hypothesize that psychoeducation group therapy will be effective in~     refuting the myths and will lead to better treatment adherence, longer remissions, fewer~     hospitalizations, improved self esteem, increased optimism, and better control over the~     disease process. The investigators also believe that they will identify some beliefs/myths or~     preconceived notions that are common to both caregivers and individuals with BAD.~   "
235411|NCT00474344|"~     The goal of this study is to identify and characterize the genetic loci causing idiopathic~     talipes equinovarus (clubfoot).~      The hypothesis is that a few genes account for a substantial fraction of ITEV and that these~     genes can be identified in defined populations. Towards this goal, in preliminary studies,~     Dr. Hecht's group has identified two genes, NAT2 and CASP10, which demonstrate evidence for~     linkage and association to ITEV.~   "
235412|NCT00474331|"~     The investigator's goal for this project is to examine the causes of the wide variability of~     the expression of Hereditary Multiple Exostoses (HME). Previous work completed by our group~     shows that there exists a correlation between genotype and phenotype such that certain~     mutations or affected genes cause certain patterns of presentation, symptoms, and signs. The~     investigators intend to achieve this goal by increasing our study sample size to build upon~     the results generated from the pilot project of this study, in order to obtain statistical~     significance. This will be achieved by performing genotype-phenotype analysis on new families~     presenting with HME in British Columbia.~   "
235413|NCT00474318|"~     The five Teen-LABS clinical centers use standardized techniques to assess the short and~     longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.~   "
235415|NCT00474292|"~     This study will examine how the brain rewires itself to make up for the lack of movement many~     people with stroke experience. It will try to determine if the rewiring differs depending on~     the location of the stroke and the amount of time since the stroke occurred. For some stoke~     patients, weakness may persist, while others recover completely after time. It is not known~     which parts of the brain are involved in the recovery of different types of stroke and if the~     type of stroke affects recovery.~      People 18 years of age and older who have had subacute thromboembolic or hemorrhagic stroke~     more than 3 months before enrolling may participate in this study.~      Participants come to the NIH Clinical Center three times every 2 years for up to 10 years. At~     the first visit, patients have a neurological examination and perform tests of motor~     abilities such as lifting small objects, turning cards, using a spoon, stacking checkers and~     lifting cans during a short period of time as rapidly as possible.~      At the second visit, subjects have structural magnetic resonance imaging (MRI) scans of the~     brain. MRI uses a strong magnetic field and radio waves to obtain images of body organs and~     tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During~     the scan, the subject lies on a table that can slide in and out of the cylinder, wearing~     earplugs to muffle loud knocking noises associated with the scanning process. Total scan time~     is about 30 minutes~      At the third visit, subjects perform some simple movement tasks during functional MRI (fMRI)~     scans. The procedure is the same as with structural MRI, except that subjects are asked to~     perform simple movement tasks in the scanner. Before the fMRI scans, electrodes are attached~     to the subject's arms and legs to monitor muscle activity (surface electromyography). Total~     scan time is about 1.5 hours. Movement tasks might include pinching a force-measuring~     instrument with the fingers, pressing different keys on a keyboard as fast as possible,~     inserting pegs into small holes on a board, lifting weights, flipping cards or similar~     activities.~   "
235416|NCT00474279|"~     The purpose of this study is to determine whether treatment of healthy older men and women~     with oral MK-677 for 12 months will enhance pulsatile GH release and increase mean GH and~     IGF-I concentrations into the range of young adults and will have favorable effects on body~     composition and functional ability on older adults.~   "
235417|NCT00474266|"~     The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority~     of the meningococcal vaccine 134612 given with Priorix-Tetra™.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
235418|NCT00474253|"~     The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced~     by 1.2 mg/kg Zemuron® after reversal at 3 minutes by 16.0 mg/kg of Org 25969 compared with~     recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.~   "
235419|NCT00474240|"~     The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and~     in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with~     moderately high cholesterol.~   "
235420|NCT00474227|"~     Based on previous findings that mentally ill inpatients are interested in losing treatment~     associate weight gain and are capable of adhering to a weight reduction program, this study~     will investigate the effects of participation in nutrition intervention, physical exercise~     and will monitor measurement of metabolic profiles (cholesterol, triglycerides and glucose).~     Hypothesis: participants will reduce weight, maintain weight loss and experience reduction in~     metabolic values and will experience improved quality of life.~   "
235421|NCT00474214|"~     The purpose of this study is to determine if early hospital discharge (at 48-72 hours), is~     feasible, safe, cost-effective, and/or improves compliance with medications, positive~     lifestyle changes and quality-of-life, in low-risk patients with ST-elevation myocardial~     infarction treated with primary percutaneous coronary intervention (primary PCI).~   "
235422|NCT00474201|"~     This study will determine whether the protease inhibitor lopinavir/ ritonavir (Kaletra~     (Trademark)), which is used to treat HIV disease, lowers blood levels of the lipid-regulating~     drug gemfibrozil (Lopid (Trademark)) in HIV-negative healthy volunteers. Many patients with~     HIV infection who take protease inhibitors have abnormally high lipids (cholesterol and~     triglycerides). Gemfibrozil, commonly used to treat high triglycerides, often is not~     effective in HIV-infected patients taking protease inhibitors, possibly because of an~     interaction between the two medicines that causes a lowering of gemfibrozil's levels in the~     blood. Results from this study will give researchers information on whether lopinavir/~     ritonavir affects the blood levels of gemfibrozil.~      Healthy, normal volunteers between 18 and 65 years old who test negative for HIV may be~     eligible for this study.~      On study day 1, subjects have a blood sample drawn from a catheter inserted into a vein in~     the arm to determine pre-dosing blood levels of gemfibrozil. They then take a gemfibrozil~     tablet and are given breakfast 30 minutes after taking the drug. Blood samples are obtained~     through the catheter at 0, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after dosing to determine~     gemfibrozil levels at those intervals. At the end of 12 hours, the catheter is removed and~     the subject is discharged from the clinic. The next morning subjects return to the clinic for~     another blood sample, collected through a vein in the arm.~      Subjects begin taking lopinavir/ ritonavir between 7 and 35 days after their first dose,~     depending on their schedule and the clinic schedule. On the fourteenth day of dosing subjects~     come to the clinic and are given a single dose of gemfibrozil, as on study day 1, and have~     breakfast 30 minutes later. Blood samples are collected to determine gemfibrozil levels just~     like on study days 1 and 2. An additional sample is collected for routine lab tests.~   "
235423|NCT00474188|"~     To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with~     dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.~   "
235424|NCT00474175|"~     To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache~     and to assess the subject's compliance with proposed label directions.~   "
235425|NCT00474162|"~     Pregnant women are more likely to form clots than non-pregnant women as pregnancy increases~     the clotting factors present in the blood. This helps to prevent excess bleeding (hemorrhage)~     at the time of delivery. Hemorrhage occurs in 5-15% of pregnancies throughout the world, even~     when delivery is by cesarean section. When hemorrhage occurs the anesthesiologist will~     normally administer fluids into the woman's vein (intravenously) rapidly to replace the blood~     that the woman has lost. Two types of fluids are commonly used. One is a salt water solution~     (saline) and the other is a starch water solution (pentastarch). Use of either or both of~     these solutions is common during hemorrhage.~      These same solutions (salt water solution and starch solution) are used at BC Women's~     Hospital during spinal anesthesia to prevent and treat low blood pressure (a common side~     effect of spinal anesthesia). This is standard practice whether you are in this study or not.~     You may also be given, depending on the anesthesiologist's preference, a drug (vasopressor)~     that causes the blood vessels to become narrow (constrict) to prevent or treat the low blood~     pressure. Whether you agree to be part of the study or not, your anesthesiologist will be~     watching your blood pressure closely throughout your operation and if your blood pressure~     becomes low he/she will treat it as is normally done.~      Low blood pressure will also occur during hemorrhage. It is therefore important that we~     determine whether the starch solution, which is more effective than the salt solution in~     preventing low blood pressure during spinal anesthesia, does or does not affect clotting.~      Research in non-pregnant adults (male and female) has found that laboratory tests of blood~     clotting change with these solutions. For saline the evidence in some studies suggests that~     the blood may clot better than normal while other studies suggest the opposite (does not clot~     as well). In pregnant and non-pregnant adults the blood does not clot as well with certain~     starch solutions. The starch solution used at BC Women's Hospital is called pentastarch and~     no research has looked at its effect on clotting in pregnant women. In non-pregnant adults~     pentastarch has less effect on clotting than other starch solutions.~      The purpose of the study is to see how pentastarch (starch solution) and normal saline (water~     with salt in it) given at the time of spinal anesthesia for elective cesarean section affect~     the ability of pregnant woman's blood to clot.~   "
235426|NCT00474136|"~     The purpose of this study is to assess the pharmacokinetic parameters of intravenous~     diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose~     administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved~     reference product.~   "
235427|NCT00474123|"~     Among patients with stable coronary artery disease (CAD), it is not clear if the pleiotropic~     effects of cholesterol reduction differ between high-dose simvastatin alone and combined~     ezetimibe/simvastatin.~      The investigators sought to compare the anti-inflammatory and anti-platelet effects of~     ezetimibe 10 mg / simvastatin 20 mg (E10/S20) to simvastatin 80 mg (S80).~   "
235428|NCT00474110|"~     The treatment of cancer in children may result in an extremely painful condition called oral~     mucositis when the cells lining the mouth are injured due to the cancer medication. Patients~     with this condition are often unable to take anything by mouth or to swallow their own~     saliva. This severe pain may last for as long as 2 weeks. A survey of our previous 22~     patients showed high daily pain scores despite the use of intravenous (given through a small~     tube in a vein) opioid medications (family of pain relieving drugs, e.g. morphine and~     hydromorphone).~      The purpose of this pilot study is to determine which of 3 concentrations of ketamine to~     combine with hydromorphone to provide the best pain relief with minimum side effects. The~     results from this study will allow us to do a larger study to compare the best concentration~     found from this study to standard treatment. If successful, this combination of ketamine and~     hydromorphone will also be used to treat other pain problems in children.~   "
235429|NCT00474097|"~     The purpose of this study is to assess if follow-up telephone calls after colorectal surgery~     affects a patient's satisfaction, the outcome of their surgery, and their quality of life. In~     addition, readmissions, complications and emergency room visits can be tracked via these~     telephone calls, ensuring optimal communication between patients and the surgical office.~   "
235430|NCT00474084|"~     The purpose of this first feasibility study is to evaluate the performance of Vesta™ &~     VestaCOR™ (Hydroxy-Apetite coated GenX) stent in de novo native coronary artery lesions. This~     study will provide the longest follow-up experience available.~      This is a randomized, double blind study conducted at three sites, two sites in India and one~     in The Netherlands. To be eligible, a patient will be required to have a de novo stenotic~     lesion of a length that could be covered by a single stent in a native coronary artery of~     diameter 3.0mm and 3.5mm. A total of at least 60 patients and a maximum of 70 patients will~     be treated with Vesta™ & VestaCOR™ stent. These patients will be randomized to either a~     smooth surface nanofilm coated stent (= VestaCOR™) (approx. 35 patients) or to a porous~     coated stent (= Vesta™) (approx. 35 patients).~      All patients will be followed clinically at 30 days, 4 months, 9 months, 1, 2, 3, 4 and 5~     years.~   "
235431|NCT00474071|"~     The routine medications to relax the muscles of the throat are an anesthetic drug, propofol,~     in combination with an ultra short acting pain medicine, remifentanil. Remifentanil is used~     to reduce the amount of propofol required but also to decrease the natural cough reflex to~     the breathing tube being inserted.The purpose of this study is to find the dose of~     remifentanil when combined with propofol which provides the best conditions for intubation~     without cough in infants and small children.Younger children may need higher doses of~     Remifentanil to facilitate intubation as they are more tolerant to the respiratory depressant~     effect of Remifentanil.~   "
235432|NCT00474058|"~     The objective of this trial is to assess the effects of transdermal rotigotine on the control~     of early morning motor function and sleep disorders compared to placebo in subjects with~     idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and~     non-motor symptoms of Parkinson´s disease will be evaluated.~   "
235433|NCT00474045|"~     This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of~     this trial is to compare the effect and safety on blood glucose control in pregnant women~     with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH~     insulin) given as long-acting insulin in combination with a short-acting insulin (insulin~     aspart).~   "
235434|NCT00474032|"~     The purpose of this study is to determine the effectiveness of treatment of idiopathic~     clubfoot utilizing Botulinum Toxin Type A (Botox). This is not a hypothesis-generating study~     as we are reporting on outcomes of patients who have been treated by this method of clubfoot~     treatment.~   "
235435|NCT00474019|"~     The purpose of this research study is to evaluate how much of repeated once daily intravenous~     (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized~     children aged 0-17 years old that require acid suppression therapy.~   "
235436|NCT00474006|"~     Determine the effects of escalated dose of daunorubicin in induction treatment of adult~     patients with acute myelogenous leukemia who are younger than 60 years of age.~   "
235437|NCT00473993|"~     Hepatitis C viral infection is common among opioid addicts in Zurich, Switzerland. The~     majority undergoes a maintenance treatment with methadone, heroin or buprenorphine. While~     stabilized by an opioid maintenance treatment (OMT)chronic hepatitis C can be treated with~     pegylated interferon plus ribavirin. As not sufficiently known, the results are comparable to~     the results of the treatment of nonaddicts.~      Our crossectional study investigates how many patients undergoing OMT are adequately~     investigated concerning hepatitis C. If not, why are they not adequately investigated and~     treated? Representative data are collected in the local clinics and medical practices~     involved in OMT in the Kanton of Zurich. The patients files are revised and the involved~     doctors are asked through a structured interview.~   "
235438|NCT00473980|"~     The study is designed to evaluate effects of NSAIDs on immune activity inside and close to~     tumor tissue in patients with colorectal cancer.~   "
235439|NCT00473967|"~     Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life~     cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in~     challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2~     Hookworm Vaccine was safe and immunogenic. This study will evaluate its safety and~     immunogenicity in individuals living in an area of endemic hookworm infection.~   "
235440|NCT00473954|"~     Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the~     body's cells. When genes are damaged, the body may be unable to produce a group of proteins,~     called cytokines, used by the immune system to fight cancer and some infections. The~     investigational gene transfer agent EGEN-001 contains the human gene for the cytokine~     interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the~     body to produce cytokines. Therefore, the purpose of the EGEN-001 therapy is to attempt to~     enhance the body's natural ability to recognize and fight cancer cells. Funding Source - FDA~     OOPD~   "
235441|NCT00473941|"~     The purpose of the study is to find new ways to improve the quality of life of people who~     have been treated for colon or rectal cancer.~   "
235442|NCT00473928|"~     The objective of this study is to provide initial safety and tolerability information of~     intravitreal POT-4 for treatment of patients with AMD~   "
235444|NCT00473902|"~     We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could~     enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM);~     decrease body fat) following resistance exercise training in older adults (> 65 y). Our study~     hypothesized that administering CrM and CLA would yield greater strength and body composition~     benefits than the placebo group over the six months of resistance exercise~   "
235445|NCT00473889|"~     This Phase III clinical trial which incorporates an initial Phase II component will determine~     the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and~     paclitaxel plus carboplatin~   "
235446|NCT00473876|"~     Will metformin improve exercise capacity in chronic heart failure patients who has insulin~     resistance (pre-diabetic- means before they become diabetic)?~   "
235447|NCT00473863|"~     The purpose of this study is to determine whether Coronary Computed Tomographic Angiography~     (CCTA) will increase patient safety by decreasing the rate of missed ACS and adverse events~     in patients who receive standard care plus CCTA versus standard care alone. Additional goals~     of the study are to determine whether CCTA can safely reduce the duration of ED visits and~     the number and duration of hospital admissions.~   "
235448|NCT00473850|"~     The purpose of this study is to establish the genetic profile of families in British Columbia~     with HME.~   "
235449|NCT00473837|"~     The pathogenesis of post-malaria anaemia is multifactorial. Iron supplementation remains the~     mainstay of management of moderate and severe anaemia; however the management of mild anaemia~     (Hb 80-110g/l) is problematic as population supplementation studies of children in malaria~     endemic areas demonstrate adverse effects in children with mild anaemia. We hypothesize that~     the anti-inflammatory, anti-malarial and anti-macrophageal iron loading effects of~     chloroquine could make it a useful drug in the management of mild post malaria anaemia. To~     test this hypothesis, we plan to randomize children (aged 12 months to 6 years) with post~     malaria anaemia (Hb 70-110g/l) to receive a standard anti-malarial treatment, co-artemether .~     All children with parasitologic cure after three days on treatment will be randomised to~     receive either weekly chloroquine or weekly placebo starting from day 10 till day 90. By~     comparing the curve of haemoglobin change between day 3 and day 30 in the placebo arms of the~     two groups, we will test the effect of chloroquine vs. ACT treatment on macrophageal iron~     loading and release in acute clinical malaria. By comparing the haemoglobin change between~     day 3 and day 90 between the weekly chloroquine arms and the weekly placebo arms we will test~     the longer-term anti-inflammatory and anti- malarial effects of weekly chloroquine~     prophylaxis. In addition to the primary endpoint, we plan to assess potential mechanisms of~     action by determining parasite clearance, peripheral cytokine production and iron flux~   "
235450|NCT00473824|"~     A Phase 2 study to evaluate safety, pharmacokinetics and efficacy of Hepatitis C Immune~     Globulin Intravenous (human) [Civacir(TM)] for preventing or reducing the impact of recurrent~     HCV infection following liver transplantation.~   "
235451|NCT00473811|"~     By improving glycemic control, many of the devastating complications of diabetes are to a~     large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic~     control is relatively new and untested. However, a low GI diet may be a cost-effective~     approach to preventing diabetes-related complications. The aim of this proposed 2-year study~     is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI~     intervention, to reduce dietary GI in patients with type 2 diabetes, and to compare it with a~     nutritionist-delivered standard American Diabetes Association (ADA) diet intervention. Our~     outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood~     lipids, blood pressure, and body mass index), dietary GI scores and acceptability of the~     intervention.~      Primary hypotheses:~      1. Recruitment and retention rates for the low GI intervention will be satisfactory.~      Secondary hypotheses:~        1. Participants in the low GI intervention group will show more favorable changes in~          physiological measures than participants in the ADA diet group.~        2. Participants in the low GI group will be successful in lowering the GI of their diet.~        3. Participants will find the intervention acceptable.~   "
235452|NCT00473798|"~     Primary Objectives:~        1. To compare levels of patient anxiety, pain, and satisfaction associated with optical~          spectroscopy procedures and MDC with the levels associated with colposcopically-directed~          biopsy in the cervical cancer diagnostic setting and with Papanicolaou smear in the~          screening setting. This aim will be addressed in Studies A and A' -- Procedure-Related~          Distress and Patient Satisfaction.~        2. To evaluate differences in psychological distress, satisfaction, and adherence to~          treatment in the two arms of a randomized trial; one group will be diagnosed with usual~          care procedures (Papanicolaou smear and colposcopically-directed biopsy) plus optical~          spectroscopy and the second will receive usual care. Aim 2 will be accomplished in Study~          B -- Psychological Distress, Satisfaction, and Adherence Outcomes in a Randomized Trial~          of Optical Spectroscopy.~        3. To assess the psychosocial and behavioral impact of a false positive screening result.~          This will be done in Study C -- Impact of False Positive Screening Test on Psychological~          Distress and Future Screening Intentions.~        4. To assess provider receptivity to optical spectroscopy. Aim 4 will be accomplished in~          Study D -- Survey of Health Care Providers.~   "
235453|NCT00473785|"~     The purpose of this study is to provide lifestyle counselling for protective health behavior~     (exercise, diet, smoking cessation) to small groups (6-8 subjects) via teleconference. The~     sample includes individuals at elevated risk for cardiovascular disease (CVD) as well as~     individuals with established CVD. Our hypothesis is that telephone-based lifestyle~     counselling will (1) significantly increase protective lifestyle behavior (diet, exercise,~     smoke-free living) and (2) significantly reduce CVD risk factors at 6-month follow-up.~   "
235454|NCT00473772|"~     The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent~     Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with~     nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length for procedural~     success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM~     stent.~   "
235455|NCT00473746|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and~     anti‑tumor activities of abiraterone acetate (also referred to as CB7630) in patients with~     hormone refractory prostate cancer (HRPC).~   "
235456|NCT00473733|"~     Glucagon like peptides receptors expression in the stomach of diabetes type 2 Glucagon like~     peptides (GLP-1, GLP-2), are hormones secreted by L cells located along the gastrointestinal~     tract. These hormones are secreted after meals and have some roles in regulating the~     digestion process, absorption, and sending signals to the brain that regulate food~     consumption. GLP peptides affect peripheral targets and have an important homeostatic role.~     GLP-1 decreases the circulatory glucose level and GLP-2 has trophic effects which enable~     adequate intestine growth.~      We aimed in our study to investigate the GLP-1 and GLP-2 receptor expression in different~     zones of the stomach in diabetes type 2 patients. If there are differences, it might explain~     the pathological gastric emptying in these patients.~      Understanding the function of these peptides may lead to new therapeutic options for diabetic~     patients with delayed gastric emptying.~      Methods: 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included~     in the study and 20 controls aged 18-70 years. Patients with neurological disease will be~     excluded. During esophagogastroduodenoscopy 3 biopsies will be taken from the antrum, corpus~     and cardia. The biopsies will be stored in -70. After RNA extraction the GLP receptors~     expression will established by real time PCR method. Patients with different expression~     compared to control will undergo isotopic scan for gastric emptying.~   "
235457|NCT00473720|"~     This is a phase I dose escalating study of oral satraplatin in combination with Abraxane~     administered weekly for three out of every four weeks in patients with advanced solid~     cancers.~   "
235458|NCT00473707|"~     The purpose of this study is to determine if giving oxytocin immediately after delivery~     causes less bleeding, transfusion needs and hastens delivery of placenta.~   "
235459|NCT00473694|"~     The purpose of the trial is to demonstrate a faster recovery from neuromuscular block with~     rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by~     70 μg/kg of neostigmine~   "
235460|NCT00473681|"~     The primary objective of the proposed clinical trials is to compare the differential~     reduction in blood pressure in underserved hypertensive adult Korean American. The study is~     designed to test the effectiveness of a comprehensive self-help intervention program.~   "
235461|NCT00473668|"~     The purpose of this observer-blind study is to generate immunogenicity data with one~     formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and~     to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK~     Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response.~     Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib~     vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,~     Sep 2007.~   "
235462|NCT00473655|"~     The primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and~     20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride~     levels.~   "
235463|NCT00473642|"~     In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced~     fluence PDT combination therapy with ranibizumab. The researchers hope to gain information~     regarding the use of reduced fluence PDT combination therapy. The information gained from~     this pilot study may prompt further definitive studies comparing the safety and efficacy of~     both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and~     ranibizumab monotherapy.~      The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to~     ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All~     patients will receive three consecutive monthly treatments with ranibizumab. Patients will be~     randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab.~     Patients randomized to group 2 will also receive one treatment with reduced fluence (50%~     fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one~     treatment with standard fluence verteporfin PDT. All patients will also be evaluated for~     possible retreatment with ranibizumab and verteporfin PDT according to established criteria.~     Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time~     of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.~   "
235464|NCT00473616|"~     This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to~     evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes~     of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The~     study is sponsored by AstraZeneca.~   "
235465|NCT00473603|"~     The purpose of this study is to determine whether free fatty acids modify the androgen levels~     in healthy young women.~   "
235466|NCT00473590|"~     This is a randomized, blinded, placebo-controlled, multicenter, Phase II study designed to~     provide a preliminary assessment of the safety and efficacy of combining bevacizumab with~     bortezomib in patients with relapsed or refractory multiple myeloma.~   "
235467|NCT00473577|"~     To determine the maximum tolerated dose (MTD) of CRA-024781 IV given by 2-hour intravenous~     infusions in patients with refractory solid or hematologic malignancies. To evaluate safety~     and tolerability, pharmacokinetics and pharmacodynamics, and to evaluate bioavailability of~     CRA-024781 IV when administered in a single oral dose.~   "
235468|NCT00473564|"~     To evaluate the use of the daVinci Robotic System for better visibility and access of head~     and neck lesions and decreased amount of surgery time.~   "
235469|NCT00473551|"~     Primary Objective:~      1. To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes,~     defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at~     90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells.~      Secondary Objective:~      1. Toxicity, response rate, time to progression and overall survival.~   "
235470|NCT00473538|"~     Lifestyle modifications are successfully employed in polycystic ovarian syndrome (PCOS)~     improving menstrual cycles and fertility. Unfortunately, the compliance over the time is very~     low. Recently, we have showed a high adherence to structured exercise training (SET) program~     in women with PCOS. The current study will be aimed to compare the efficacy of the SET~     program with a diet program on the reproductive function in obese anovulatory infertile PCOS~     patients.~   "
235471|NCT00473525|"~     The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of~     multiple parallel doses of PF-00734200 following oral administration to adult human subjects~     with T2DM who currently are on a stable dose of metformin.~   "
235472|NCT00473512|"~     The purpose of this study is to determine the maximum tolerated dose and evaluate the safety,~     tolerability, and activity at the recommended dose (maximum tolerated dose [MTD]) of~     abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate~     (gland that makes fluid that aids movement of sperm) cancer (HRPC).~   "
235473|NCT00473499|"~     The aim of the PEPCAD III substudy is to assess the efficacy of the Paclitaxel-eluting DEBlue~     stent system in the treatment of stenoses in native coronary arteries compared to the~     Sirolimus-eluting Cypher stent by intravascular ultrasound (IVUS) and to study the influence~     of both devices on endothelial function, coronary flow reserve, and stem cell mobilization.~   "
235474|NCT00473486|"~     The majority of patients with advanced NSCLC treated with standard platinum based~     chemotherapy regimens ultimately develop disease progression. Active therapies with improved~     toxicity profiles are clearly needed in this setting. The primary objective of this trial is~     to assess the toxicity profile and to determine the effect on progression free survival and~     time to progression in patients with advanced NSCLC treated with sorafenib in addition to~     carboplatin and pemetrexed.~   "
235475|NCT00473473|"~     ICU-Protocol.Summary Profuse and tenacious tracheal secretions are a significant factor~     impeding the weaning process in mechanically ventilated patients in the intensive care unit~     (ICU). In homeopathy, high dilutions of plant extracts, minerals, and other biological~     substances are used as remedies for the treatment of illness, which is based on the Law of~     Similars (the higher the dilution, the stronger the effect). Kali Bichromicum (potassium~     dichromate) is a drug that is commonly used in homeopathy, mostly for conditions involving~     profuse, stringy, tenacious mucous and tracheal secretions. A recent randomized,~     double-blind, placebo-controlled study found a statistically significant effect of this~     remedy on improving the amount of tracheal secretion, timing to extubation and discharge from~     the ICU among critically ill patients, with no side effects observed.~      The proposed study will compare the efficacy of Kali bichromicum 10-60 (C30) versus placebo~     in reducing the amount of tracheal secretions in patients intubated with a conventional~     endotracheal tube or tracheostomy and receiving controlled mechanical ventilation in the ICU~     setting. The quantity of the secretions will be studied, as well as sputum neutrophil count~     (using direct microscopy). Time to extubation and the need for re-intubation will also be~     evaluated. 56 patients over the age of 18 years treated with mechanical ventilation for at~     least 3 days will be recruited from the ICU departments of 4 medical centers in Israel. The~     preparations will be administered in the form of small pellet-like globules, which will be~     placed on the mucosa of the mouth, to the side of the endotracheal tube. Patients will be~     randomly allocated to either verum (n=28) or placebo (n=28) treatment, with the remedies~     administered twice daily with an interval of 12 hours, for a period of up to 14 days or until~     the patient is extubated. Any adverse event will be recorded.~   "
235476|NCT00473460|"~     Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine~     if this drug, when taken periodically in addition to the patients normal treatment, is~     effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately~     1132 subjects will participate, and it is expected that the study will run for 2 years in~     order to reach that goal. The patients individual involvement in the study will be 17 months.~     Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication~     (moxifloxacin or placebo) will be taken in addition to the patients normal medication for~     chronic bronchitis. In addition to the first clinic visit, called a screening visit, the~     patient will be required to come back to the clinic for ten more study visits, every 8 weeks.~     At the first visit the study co-ordinator will provide him with the dates for all the visits.~     Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will~     receive the study medication which he will take for five days, in addition to his normal~     treatment for chronic bronchitis. After this time the patient will enter a follow up period~     for 24 weeks, where he will come to the clinic for assessments and continue to take his~     normal medication but not receive the study drug. A complete medical history will be taken at~     the first visit, including the patients past and current smoking habit. A breath test will be~     performed to assess how well his lungs are functioning. In addition, he will also be asked to~     provide a sputum sample for a microbiological examination to identify any bacteria present in~     the sample. The patient must be able to provide a sputum sample at the screening visit. If~     the patient meets all the inclusion / exclusion criteria for the study, he will be allocated~     randomly to one of the following treatment groups at the second visit.- Treatment group 1:~     Receives moxifloxacin orally once daily for five days.- Treatment group 2: Receives a~     matching placebo once daily for five days.In between each visit (four weeks after your clinic~     visit), the study site co-ordinator will contact the patient to check on his well being. If~     the patient or the doctor decides to stop the patients participation in the trial for any~     reason, the patient will be required to return to the clinic for a physical examination, take~     a breath test, provide a sputum sample (if possible) and have a blood sample taken.~   "
235477|NCT00473447|"~     The purpose of this study is to determine if a modified protocol of constraint-induced~     movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children~     with cerebral palsy. In these children one main problem the non-use of the affected arm. Many~     studies showed that the non-use phenomenon can by reversed by the CIT, a rehabilitation~     program consisting of 15 days of restraining the unaffected arm plus a daily intensive (6~     hours/day) physiotherapy training of the paretic arm. The present study aims at evaluating if~     a shortened CIT protocol (restraining device plus only 2 weekly hours of physiotherapy) is~     effective in improving use and function of children paretic arm~   "
235478|NCT00473434|"~     The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in~     patients with schizophrenia who are switched from an oral atypical antipsychotic to~     Paliperidone ER. In this study patients and physicians know the name and the dose of the~     study drug. Newly diagnosed patients will also be included in the study. In general, the~     recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a~     higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can~     be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was~     chosen to best mimic actual clinical practice.The safety assessments to be conducted~     throughout this study including the regular monitoring and recording of all Adverse Events~     and Serious Adverse Events.~   "
235479|NCT00473421|"~     Joint replacement is a well-documented and cost effective treatment of degenerative diseases~     in the hip (1,2). There are two different principles of fixation of prosthesis components;~     cemented and uncemented. The most common mode of fixation in Scandinavia has historically~     been with bone cement. In the recent years a reverse hybrid combination (uncemented stem and~     cemented cup) is gaining popularity, especially in Norway.~      Beside luxation, infection and venous thromboembolism, the problem with aseptic loosening is~     a known complication. A marker for aseptic loosening is local bone loss around the~     components. This is measured with a densiometer and the method is Dual Energy X-ray~     Absorbtiometry (DXA). Periprosthetic bone loss is evaluated by series of DXA scans around the~     components over time. This enables us to follow changes in bone mineral density (BMD) close~     to the prosthesis.~      We want to compare cemented and uncemented prostheses with this technique. This is a problem~     since we don’t know how much different contrast medias in bone cement affect DXA scans. This~     area is poorly investigated. Attempts have been made to exclude the cement-mantle from the~     measurements both digitally and manually, but these have showed poor precision. A kind of~     consensus of assuming that contrast medias in bone cement give an increase in measured BMD of~     20% (4). This is used when comparing cemented and uncemented components.~      We have preformed laboratory tests of different cements. Zirconium oxide (ZrO2) and Barium~     sulphate (BaSO4) are used as radiopacifiers. These contrast medias have different properties.~     Our test showed that Zirconium give 63% higher BMD when we scanned cement alone.~      This is supported by a cadaver study showing significant differences between contrast free~     cement and ZrO2 /BaSO4 containing cements.~      It is our opinion that it is necessary to perform a prospective study to investigate this~     more thoroughly.~      The hypothesis of this study is that it is not accurate enough to add 20% in BMD for cemented~     implants when comparing them with uncemented implants. It is probably necessary to take into~     account the amount of cement used and kind of contrast medium.~   "
235480|NCT00473408|"~     The purpose of the current trial is to explore whether the standard treatment with~     radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade~     astrocytomas. If vascular effects are identified, future clinical trials can be proposed~     wherein anti-angiogenic agents are added to increase patient survival.~   "
235481|NCT00473382|"~     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled~     study of the efficacy and safety of ranibizumab injection in patients with clinically~     significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus~     (Type 1 or 2). This study is identical in design to study NCT00473330 (Protocol ID FVF4170g).~      The open-label extension phase of the study was stopped after receiving FDA approval of the~     study drug (ranibizumab) for diabetic macular edema.~   "
235482|NCT00473369|"~     Context: Pituitary adenoma is generally indolent, but an aggressive subtype called atypical~     adenoma has uncertain prognosis, and an unclear relationship between prognosis and~     morphology.~      Objective: This study investigated the prognostic factors of this tumor. Design:~     Retrospective analysis. Setting: University and associated hospitals.~   "
235483|NCT00473356|"~     The Focus of this study is to look at the role of nutrition in maintaining lean body mass~     post-gastric bypass surgery. The purpose of this study is to test whether LBM is increased in~     those patients receiving a nutritional supplement of amino acids is enhanced when compared to~     control patients not receiving the supplement.~   "
235484|NCT00473343|"~     Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light~     activation of a photosensitiser in the presence of oxygen. These cells accumulate more~     photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon~     illumination.~      For skin diseases, there has been an increasing interest in using precursors of the~     endogenous photoactive porphyrins. The most commonly used precursors have been~     5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the~     methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .~      BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all~     non-melanoma skin cancers . It is the most common cancer in humans . Several~     non-pharmacological treatment modalities are used for BCC, including excision surgery,~     curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation~     therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on~     the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good~     response rates in the majority of patients but are inadequate in a small group of patients~     defined as high-risk BCC.~      In this particular patient group, even a moderate complete response rate with good cosmetic~     results may be considered beneficial, since the number of patients who have to receive more~     advanced therapy with the possibility of high morbidity and poor cosmetic outcome will be~     reduced. Even a partial response is of clinical interest since the remaining tumour will~     require less extensive surgery. In the case of treatment failure, Metvix PDT does not~     interfere with the use of other treatment modalities.~      The variable complete response after one or two Metvix treatment cycles will be used as the~     basis for the justification of sample size. The following hypothesis will be tested:~      H0: Complete response rate of Metvix is less or equal to 65 % versus the alternative~     hypothesis HA: Complete response rate of Metvix is greater than 65 %~   "
235485|NCT00473330|"~     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled~     study of the efficacy and safety of ranibizumab injection in patients with clinically~     significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus~     (Type 1 or 2). This study is identical in design to study NCT00473382 (Protocol ID FVF4168g).~      The open-label extension phase of the study was stopped after receiving FDA approval of the~     study drug (ranibizumab) for diabetic macular edema.~   "
235486|NCT00473317|"~     When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is,~     moved into the bloodstream. When the skin is exposed to sunlight during summer months,~     Vitamin D is made there and then modified into more active forms by the liver and kidneys.~     These more active forms of Vitamin D improve calcium absorption. Many adults living in the~     U.S. have little or no sun exposure and are low in Vitamin D. We know that specific~     wavelengths of sunlight called Ultraviolet-B cause Vitamin D to be made in the skin.~   "
235487|NCT00473304|"~     To evaluate the safety, efficacy and physiological performance of daily disposable spherical~     and toric soft contact lenses in a vision-corrected population of children ages 8-11 years of~     age. To evaluate the ability of the practitioner to fit these lenses and for the children to~     wear and manage these lenses.~   "
235488|NCT00473291|"~     The primary purpose of this study is evaluate the VRI device's accuracy in diagnosis of~     pleural effusion (in comparison to chest x-ray and ultrasonography), and to assess the~     pleural effusion location and size. The VRI system uses pressure sensors (electronic~     stethoscopes) to record the energy created by the airflow in the lungs during breathing.~   "
235489|NCT00473278|"~     The significance of our study is in the importance of understanding the quality and quantity~     of proteins in the human tear film, and any unique aspects of tears in children. This pilot~     study will provide data to plan prospective research to better delineate the utility of tear~     proteins in diagnosing and following disease status in a non-invasive fashion.~   "
235490|NCT00473265|"~     Whereas much information is known about the properties of bone in primary~     hyperparathyroidism, a disorder of parathyroid hormone (PTH) excess, virtually nothing is~     known about the skeleton in hypoparathyroidism, a disorder in which PTH is absent. The~     purpose of this research project is to test the hypothesis that the skeleton in~     hypoparathyroidism is abnormal in its metabolic, densitometric, geometric, biomechanical and~     microarchitectural features. We will also test the hypothesis that the skeleton is dependent~     upon PTH for normal structure and function. Using non-invasive approaches as well as direct~     analysis of bone itself, the human hypoparathyroid skeleton will be thoroughly characterized.~     With each patient serving as his/her own control, we will determine how, to what extent, and~     in what ways the administration of PTH restores skeletal dynamics and structure to the~     hypoparathyroid skeleton. In this way, we will identify those structural and dynamic elements~     of the skeleton that are influenced by or dependent upon PTH. Methods to be utilized include~     dual energy X-ray absorptiometry, quantitative central and peripheral computed tomography,~     geometry and size quantification, histomorphometry by standard and microCT methods, finite~     element analysis, biochemical bone markers, quantitative back scattered electron imaging, and~     Fourier Transform Infrared Spectroscopy. This research project will extend our knowledge of~     the skeletal effects of PTH to its deficient range and thus complete our understanding of PTH~     action on bone gained by our many years of studying PTH overexpression in primary~     hyperparathyroidism. This investigation may also provide insight into the means by which PTH~     helps to restore the skeleton when it is used to treat osteoporosis.~   "
235491|NCT00473252|"~     Fungal infections in immunocompromised patients occuring during construction activities in~     hospitals have repeatedly been reported.~      However, the question of a causal relation between construction activities and infections has~     never been addressed systematically and prospectively.~      To answer this question, we will monitor our immunosuppressed patients' health status, as~     well as fine dust and aspergillus spore contents in the air during a three year construction~     activity period in our hospital.~   "
235492|NCT00473239|"~     When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is,~     moved into the bloodstream. When the skin is exposed to sunlight during summer months,~     Vitamin D is made there and then modified into more active forms by the liver and kidneys.~     These more active forms of Vitamin D improve calcium absorption. Many adults living in the~     U.S. have little or no sun exposure and are low in Vitamin D. A single dose of 100,000 IU of~     Vitamin D3 has been used both as empiric treatment for Vitamin D deficiency as well as in~     controlled trials without risk of raising blood calcium to dangerous levels.This study is to~     determine the serum levels of Vitamin D and 25-hydroxyvitamin D (vitamin D after it has been~     modified by the liver) that can be expected when Vitamin D3 is given as a single oral dose of~     100,000 IU.~   "
235493|NCT00473213|"~     BetaferonR is effective in reducing relapse rate and MRI T2-weighted lesion frequency in MS~     patients at the dose of 8 MIU on alternate days (THE IFNB MS Study Group, 1993). Relapse rate~     is reduced by 30-35% (The IFNB MS Study Group, 1993), MRI activity is decreased up to 100% in~     most cases (Stone et al 1995). In some patients, however, MRI activity still occurs or~     reappears during treatment (Stone et al 1995). MRI activity has been demonstrated to~     correlate with relapse occurrence (McFarland et al, 1992; Miller et al, 1996), and in some~     patients relapses still occur during IFN beta treatment. In other patients relapses may occur~     in association with the appearance, after 9-18 months of treatment, of anti-IFN beta NAB (The~     IFNB M S Study Group, 1995).~      This protocol hypothesizes that the dose of 12 MIU BetaferonR on alternate days has more~     pronounced MRI and clinical effects in MS patients than that of 8 MIU. MS patients who do not~     respond to 8 MIU may take advantage of a higher dose. We, therefore decided to assess MRI~     effects after increasing the Betaferon dose (12 MIU) in RRMS patients showing a residual MRI~     activity (at least one new Gd enhancing lesion) during six months of standard Betaferon dose~     treatment (8 MIU).~   "
235494|NCT00473200|"~     The purpose of this study is to investigate whether S-adenosylmethionine (SAMe), a natural~     substance available as a nutritional supplement, can influence blood levels of homocysteine~     (Hcy). More specifically, we will determine if chronic oral SAMe administration affects~     homocysteine metabolism in patients with vascular disease who have mild to moderate~     hyperhomocysteinemia.~   "
235495|NCT00473187|"~     X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short~     stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral~     phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height.~     The main objective of the study is to determine the beneficial effects of recombinant human~     growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary~     objective is to monitor side effects of the therapy.~   "
235496|NCT00473174|"~     This prospective chronotherapy trial will investigate the potential differing efficacy of~     ramipril in doses from 5 to 10 mg/day when administered, as a monotherapy either upon~     awakening from nighttime sleep or at bedtime, to diurnally active patients with grade 1 or 2~     essential hypertension, who will be evaluated by 48-hour ABPM before and after pharmacologic~     intervention. The benefits from this trial may be extremely important, taking into account~        1. the high prevalence of non-dipping among patients with essential hypertension~        2. the need for a proper 24-hour BP control with particular emphasis on the regulation of~          nighttime resting BP mean~        3. the lacking information on the administration-time dependent effects on BP of ramipril,~          a widely used ACEI in doses of 5-10 mg/day.~   "
235497|NCT00473161|"~     A newly-developed device for biofeedback of surface EMG will be used to either increase or~     decrease activity in the muscles of children with poor reaching due to cerebral palsy.~   "
235498|NCT00473148|"~     Several clinical findings and clinical trials have suggested that the prognosis of intensive~     care unit (ICU) patients may be improved by minimizing the positive fluid balance. In~     particular, a global vascular overload could lead to weaning failure. The purpose of this~     international, multicenter, controlled, randomized trial is to test if the incorporation of a~     B-type natriuretic peptide (BNP) assay in a mechanical ventilation weaning protocol helps~     optimize the weaning process and reduce the duration of the ventilatory weaning period.~   "
235499|NCT00473135|"~     Dengue fever, caused by dengue viruses, is a major health problem in tropical and subtropical~     regions of the world. The purpose of this study is to evaluate the safety of and immune~     response to a 2-dose regimen of a new monovalent dengue virus vaccine. This study will test~     the dengue virus vaccine DEN1delta30 in healthy adults.~   "
235500|NCT00473122|"~     The goal of this clinical research study is to evaluate a new two-stage approach~     (delayed-immediate reconstruction) to breast reconstruction in women who may require~     post-mastectomy radiation therapy. Researchers will compare the cosmetic outcomes and any~     complications that occur in women who receive delayed-immediate reconstruction to those who~     receive the standard approaches (either immediate reconstruction or delayed breast~     reconstruction).~   "
235501|NCT00473109|"~     Conventional hemodialysis requires transient systemic anticoagulation to prevent blot~     clotting after contact with the extracorporeal circuit. However, low molecular weight heparin~     (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for~     hemorrhagic complications. In this setting, several procedures theoretically allow dialysis~     without systemic heparinization, but randomized studies to compare them are lacking. The gold~     standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (~     rises ). Two emerging procedures are increasingly used : continuous pre-dilution of the~     arterial line ( pre-dilution ) and the use of a specific dialysis membrane (NEPHRAL 400 ST)~     coated with heparin immediately before use ( heparin adsorption ).~   "
235502|NCT00473096|"~     The purpose of this study is to develop and test an informative computer-based program to~     help women in making good choices among options for treating early stage breast cancer. Women~     who are exposed to the computerized program will, when compared to women who receive standard~     of care offered at the hospital: (a) be more knowledgeable about treatment options,(b) be~     more satisfied with their treatment decision, and (c) be more assured about their treatment~     choice.~   "
235547|NCT00472498|"~     The central purpose of this study is to compare the clinical outcomes of patients who~     suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic~     defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac~     arrest before 2001.~   "
235503|NCT00473083|"~     The purpose of this trial is to determine if rash caused by erlotinib can be successfully~     treated and if so to determine the optimal treatment approach.~      Hypothesis:~      Hypothesis 1: If the incidence of rash is 50% while on erlotinib, prophylactic monotherapy~     with minocycline can prevent occurrence in 50% of these patients.~      Hypothesis 2: Treatment of rash is successful in improving rash by at least one Grade in 80%~     of patients.~      Hypothesis 3: In patients with untreated rash, the rash will be self-limiting in 25% of~     patients, and 65% will be grade 1, 2A, and 2b. Ten percent will be grade 3 requiring~     treatment with monotherapy intervention.~   "
235504|NCT00473070|"~     The purpose of this study is to determine the amount of study medication that moves from the~     front of the eye into the fluid at the front of the inside of the eye.~   "
235505|NCT00473057|"~     This is a open label study to assess the safety of autologous bone marrow transplantation in~     patients with a ischemic stroke in the middle cerebral artery territory within 90 days from~     symptoms onset.~   "
235506|NCT00473044|"~     The purpose of this study is to investigate whether a faith-based curriculum delivered in~     small groups, and emphasizing goal setting along with mutual responsibility, increases~     physical activity.~   "
235507|NCT00473031|"~     The purpose of this study is to learn how the amount of protein during moderate weight loss~     influences bone health.~   "
235508|NCT00473018|"~     This is a randomized trial to compare the effect of standard versus enhanced risk reduction~     counseling on risk behavior incidence in individuals receiving PEP medications. The study~     seeks to 1) determine if there are equivalent changes in the incidence of self-reported risk~     behaviors, STD incidence, and adherence to medications in individuals who receive enhanced~     risk reduction and adherence counseling and those who received standard risk reduction and~     adherence counseling; 2) evaluate viral and host biological factors involved in sexual~     transmission that may either influence PEP efficacy, or themselves be negatively or~     positively affected by the administration of PEP medications; and 3) contribute to the CDC~     registry in an attempt to provide crucial data for a case control analysis to establish the~     efficacy of PEP for sexual and injection drug use exposures. The principal outcome will be~     the change in participants' number of unprotected sexual acts following administration of~     PEP. This is defined as the number of prior 3-month acts of high risk unprotected sex,~     assessed at 12 months following a course of PEP, minus the number of unprotected acts the~     participant reported in the 3 and 6 months prior to beginning PEP (assessed at baseline).~     Methods to be used consist of interview data collection, questionnaires, risk reduction and~     adherence counseling and source recruitment counseling (index subject).~   "
235509|NCT00473005|"~     In order to improve the survival of metastatic breast patients, it is important to~     investigate the use of novel therapeutic agents combined with known active agents in the~     treatment of breast cancer. This is a phase I study evaluating the maximum tolerated doses~     and toxicities of RAD001 in combination with capecitabine for the treatment of metastatic~     breast cancer. RAD001 (INN: everolimus) is a novel macrolide, which is being developed as an~     antiproliferative drug with applications as an immunosuppressant and anticancer agent. Phase~     I trials in patients with solid tumors have shown that treatment with RAD001 is~     well-tolerated with a minimal side effect profile. Capecitabine (Xeloda, Roche) is an oral~     fluoropyrimidine that was approved in 1998 for the treatment of patients with metastatic~     breast cancer. The all-oral regimen of RAD001 with capecitabine is an attractive approach as~     the treatment of metastatic breast cancer has not yet proven to be curative. We also want to~     find out what possible benefit this combination of drugs might have on treating your cancer.~   "
235510|NCT00472992|"~     The primary objective of the Registry was to evaluate the outcomes of pregnancy in women with~     Multiple Sclerosis (MS) or Crohn's Disease (CD) who were exposed to TYSABRI® at any time~     within 90 days prior to first day of Last Menstrual Period (LMP) or during pregnancy.~   "
235511|NCT00472966|"~     To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a~     series of Glycolic Acid peels in treatment of moderate to severe melasma.~   "
235512|NCT00472953|"~     This trial is conducted in Europe, Asia and South America. A one-year clinical trial to~     compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with~     type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).~   "
235513|NCT00472940|"~     Cancer and its complications are common problems. In most cases, this condition has a~     profound impact on survival and quality of life (QoL). Fatigue, sexual dysfunction, decreased~     sexual drive, depression and poor appetite are commonly seen in these patients. However,~     these symptoms also are seen in men with other conditions including those with low~     testosterone levels.~      The objective of this study is to determine the number of male patients with cancer that have~     low testosterone levels and to establish the relationship between testosterone levels and the~     symptoms that these patients experience.~   "
235514|NCT00472927|"~     To evaluate three new investigational tablet formulations of the Food and Drug Administration~     (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).~   "
235515|NCT00472914|"~     A handheld surface electromyography device will be tested by clinicians on children with limb~     hypertonia, and inter-rater reliability will be assessed with and without the device.~   "
235516|NCT00472901|"~     The purpose of this study is to determine whether the afamelanotide (CUV1647) formulation is~     effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients~     with a well documented history of the disease. The study also aims to determine whether~     treatment with afamelanotide (CUV1647) can reduce the use of rescue medication in this group.~   "
235517|NCT00472888|"~     This study is planned to investigate the incidence of intraoperative floppy iris and its~     relationship with pseudoexfoliation, diabetes, hypertension as well as systemic alpha-1~     adrenergic blocker use.~   "
235518|NCT00472875|"~     To see if using medication called sulphonylureas can help improve symptoms which patients~     rely on to recognise low blood glucose levels ( hypoglycaemia) and also to see if they can~     reduce the slowing down in brain function which occurs at hypoglycaemia.~   "
235548|NCT00472485|"~     The purpose of this study is to determine the ability of several eye movement monitors, used~     in clinical practice, to identify children with poor reading eye movements. A second purpose~     of the study is to evaluate the effectiveness of eye movement therapy.~   "
235519|NCT00472862|"~     The study examines the effect of cognitive training on cognitive functioning and everyday~     competencies of patients with schizophrenia.~      120 patients are expected to be included in this randomized controlled trial running at two~     sites in Denmark starting January 2007 The effect of a 16-week, manualized program of~     cognitive training integrated in a comprehensive psychosocial treatment (OPUS) for~     first-episode schizophrenia patients is compared with the effect of standard treatment~     (OPUS). A six month follow-up assessment is conducted to investigate a possible long-term~     learning effect of cognitive training.~      Blinded assessments include the MATRICS Consensus Cognitive Battery and a co-primary outcome~     measure of cognitive improvement: A translated version of the UCSD Performance-based Skills~     Assessment (UPSA) adjusted to a Danish context.~      The cognitive training consists of four modules focusing on the domain of attention,~     executive functioning, learning and memory. Module 1 and 2 are based on computer-assisted~     training tasks, and the following modules focus on more practical everyday tasks and calendar~     training. Cognitive training takes place twice a week and every other week the patient and~     trainer engage in a dialogue on the patient's cognitive difficulties, motivational goals and~     his/her progress in competence level.~      The use of errorless learning principles, scaffolding and attentional externalisation aims at~     improving the patients' performance on cognitive and everyday tasks by learning to apply~     compensation techniques as well as limiting dysfunctional uses of available cognitive~     ressources (i.e. excessive self-focus, rumination).~      The study will provide MATRICS Consensus Cognitive Battery results from a relatively large~     Danish sample of first-episode schizophrenia and contribute with valuable normative data on~     the UPSA.~      It is hypothesized that cognitive training integrated in OPUS treatment enhances both~     cognitive and everyday competence of patients more than OPUS treatment alone. Expectations~     are that cognitive training will demonstrate a small to moderate effect on cognitive~     functioning and a moderate effect on everyday functioning as measured with the UPSA.~     Moreover, patients allocated to cognitive training are expected to show an improvement in~     self-esteem.~   "
235520|NCT00472849|"~     The goal of this clinical research study is to find the highest tolerable dose of fludarabine~     and cytarabine that can be given in combination with oxaliplatin and rituximab in the~     treatment of chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, or Richter's~     transformation. Once the highest tolerable dose for this drug combination is found, the next~     goal of the study will be to find out if this combination therapy is effective in shrinking~     or slowing the growth of these diseases.~   "
235521|NCT00472836|"~     CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal~     (kidney) function can affect their elimination from the body via metabolism. This study will~     therefore compare the pharmacokinetics (time course of drug concentrations in the body),~     safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy~     control subjects.~   "
235522|NCT00472823|"~     The purpose of this study is to examine the effects of several doses of vitamin D on hormones~     related to bone, calcium absorption, bone density and muscle strength.~   "
235523|NCT00472810|"~     The purpose of this study is to compare the safety and effectiveness of the ologen~     (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.~   "
235524|NCT00472797|"~     To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and~     injection site redness Rebif treated subjects with relapsing forms of MS who transition to a~     new formulation of Rebif (RNF).~   "
235525|NCT00472784|"~     OBJECTIVE: 1. To study tissues from spinal cord injured patients with noncompliant bladders~     as well as neurologically intact patients with normal bladder compliance, analyzing both~     quantitative and qualitative neural efferent receptors, collagen, and smooth muscle contents,~     using RT-PCR and electron microscopy. 2. To explore the possible shift in bladder neural~     architecture after SCI from beta to alpha-adrenergic receptors.~      RESEARCH DESIGN: 25 spinal cord injury patients who underwent cystoscopic procedures will be~     included in this study. 25 control patients without spinal cord injury and already scheduled~     for urologic procedures will also be included in this study.~      METHODOLOGY: Study patients will undergo flexible or rigid cystoscopy as well as selective~     cold cup biopsies of the posterior and lateral walls, and trigonal area of the bladder.~     Control patents will undergo cystoscopy and selected bladder biopsies preceding their~     scheduled urologic procedures. Tissue samples will be frozen for later EM and RT-PCR analysis~     of collagen, smooth muscle, and efferent adrenergic receptor content and subtype. Hemostasis~     will be achieved with a cautery electrode. Criteria of exclusion include active urinary tract~     infection identified by preoperative urinalysis, or the presence of suspicious lesions seen~     during cystoscopy. Suspicious areas will be biopsied and the patient will be excluded from~     the study.~      Subjects will be given a preoperative dose of Rocephin 1g IM as well as a postoperative 3-day~     course of Cipro 500 mg BID. Control patients will be given standard perioperative~     prophylactic/empiric therapy as indicated for their urologic procedure. Patients will be~     followed in 1-2 weeks to evaluate their postoperative course.~      FINDINGS: Total number of subjects enrolled: 43. 12-03: To date we have not encountered any~     problems with the study and health wise the subjects have done fine. No adverse events have~     been reported. Preliminary Results: The tissue is currently being analyzed - mRNA by~     microchip analysis and the data is still being worked on to look for correlations in genes up~     or down regulation versus the morphological EM findings previously reported.~   "
235526|NCT00472771|"~     The purpose of this study is to determine whether INNO-206 is effective in the treatment of~     small cell lung cancer.~   "
235527|NCT00472758|"~     -To evaluate the safety and tolerability of a multiple doses of this drug in adult patients.~   "
235528|NCT00472745|"~     The purpose of this study is to determine the effect of weight loss on bone health in men.~   "
235529|NCT00472732|"~     Urea cycle disorders (UCDs) are a group of rare inherited metabolism disorders. The purpose~     of this study is to evaluate how UCD-related neurologic injuries affect adults with one of~     the most common types of UCD.~   "
235530|NCT00472719|"~     The purpose of this study is to determine the safety of and immune response to an~     experimental DNA HIV vaccine followed by boosting with either an experimental adenoviral~     vector HIV vaccine of serotype 5 or 35 in HIV uninfected adults. This study will also~     determine the safety of and immune response to an adenoviral vector HIV vaccine of serotype 5~     followed by a booster of an adenoviral vector of serotype 35, or vice versa, in HIV~     uninfected adults.~   "
235531|NCT00472706|"~     The purpose of this study is to identify the most optimal therapy for Bowen's disease:~     excision versus Photodynamic therapy.~   "
235532|NCT00472693|"~     The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as~     second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer.~   "
235533|NCT00472680|"~     The purpose of this study is to learn whether the amount of dietary protein can influence~     bone health during the weight loss after weight loss surgery.~   "
235534|NCT00472667|"~     The study is a prospective, randomized, controlled intervention trial conducted in 9 centers,~     comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue~     antibiotics, in patients with suspected community or hospital- acquired infection.~   "
235535|NCT00472654|"~     The purpose of this study is to learn how the amount of vitamin D supplementation influences~     intestinal fractional calcium absorption (a measure of the amount of calcium absorbed).~   "
235536|NCT00472641|"~     This research study is designed to determine if replacing your current antipsychotic and/or~     mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being~     conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to~     be an effective medication for overweight or obese patients with bipolar disorder. There will~     be approximately 25 patients enrolled in this study.~   "
235538|NCT00472615|"~     Background and Rationale for Study: Estrogen and progesterone are female hormones that~     regulate the menstrual cycle and likely serve an important role in the regulation of mood.~     Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild~     dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days~     post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual~     mood changes that range from mild symptoms to severe worsening that require hospitalization.~     Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but~     confirmatory research is lacking.~      Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms~     throughout the menstrual cycle and to determine if women with BD have: 1) a) increased~     severity and persistence of depression and mania symptoms in the late luteal (premenstrual)~     vs early follicular phase, b) larger change in mood symptoms from the late luteal~     (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in~     the late luteal compared to the early follicular phase. The secondary aims are to determine:~     1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar~     women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory~     vs anovulatory cycles, c) antimanic drug treatment.~   "
235539|NCT00472602|"~     Opisthorchis viverrini (OV) is a parasite that individuals get from eating raw fish.~     Infections with this parasite have been associated with liver abnormalities that sometimes~     lead to bile duct cancer. The purpose of this study is to find out how many people in several~     areas of the Khon Kaen province are infected with OV, what affect this parasite has on the~     liver, how the immune system reacts to infection with this parasite, and how the liver is 12~     months after being treated for this parasite. Study participants will include 6,000~     volunteers, ages 20-60, living in villages surrounding Khon Kaen that have large numbers of~     people infected with OV. Study procedures will include a stool sample, an ultrasound (sound~     waves bounced off internal organs to create a picture), and a blood sample. Individuals found~     to test positive for the parasite will be treated at their local primary health care unit.~     Participants will be involved in study procedures for up to 12 months.~   "
235540|NCT00472589|"~     The purpose of this trial is to collect plasma, serum, whole blood and tissue samples from~     women with breast cancer and plasma, serum, whole blood from healthy women, which will be~     made available to researchers for biomarker analysis.~   "
235541|NCT00472576|"~     Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly~     improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced~     enjoyment of things in patients with major depression.~      MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate~     binds to, possibly inducing a rapid antidepressant response. People between 18 and 55 years~     of age who have major depression of at least 4 weeks' duration and have not been helped by~     two antidepressants approved for major depression may be eligible for this study. Women who~     are able to have children are excluded. Participants are admitted to the NIH Clinical Center~     for two study phases, as follows. Phase I (1 to 2 weeks): Patients are tapered off their~     current medications. Phase II (7 weeks): Patients are randomly assigned to take either~     MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At~     some point during the second part this phase, patients who had been taking MK-0657 are~     switched over to placebo and those who had been taking placebo are switched to MK-0657.~     Participants undergo the following procedures during the study:Physical examination twice (at~     the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests~     about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and~     thinking Blood pressure measurements three times a day.~      Study examines the effectiveness of a new medication, targeting a system called glutamate,~     will improve depression when compared with placebo.~   "
235542|NCT00472563|"~     Deterioration of kidney renal function occurs in a minority of people due to~     contrast-required procedures. The purpose of this study is to compare two different~     interventions to reduce the risk of kidney injury after contrast medium exposition.~      We will perform a randomized clinical trial following a modification of a previously~     published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly~     assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline~     infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will~     receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip~     rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.~   "
235543|NCT00472550|"~     To investigate the effect of 20 mg esomeprazole daily for one week on gastric emptying of 500~     ml beer, the consecutive blood alcohol levels, the gastroesophageal reflux and plasma levels~     of gastrin and CCK in a randomized, placebo-controlled, double-blinded manner in 16 healthy~     male volunteers.~      Hypothesis:~      The combined taking of esomeprazole and beer will inhibit gastric emptying as compared to the~     intake of beer alone. This will induce a delay of the ethanol absorption and of the~     consecutive blood ethanol concentrations. Gastric acid secretion after beer will be reduced~     after esomeprazole treatment. Therefore, gastroesophageal acid reflux will be reduced after~     the combined taking. We speculate that gastrin, but not CCK plasma levels, will be increased~     after the combined taking as compared to beer alone. Both, beer and PPIs, have stimulatory~     effects on gastrin release. However, the secretion of CCK from duodenal CCK-cells is~     inhibited when gastric emptying is prolonged.~   "
235544|NCT00472537|"~     This purpose of this study is to compare the recovery after an operation of an incisional~     hernia within the limits of the rectus muscles of the abdominal wall. The use of a mesh in~     the repair of a postoperative hernia is considered obligatory. Placement of a retromuscular~     mesh is done by open or laparoscopic surgery. Focus is on the recovery phase assuming a less~     painful recovery after a laparoscopic procedure.~   "
235545|NCT00472524|"~     The goal of this study is to compare the effectiveness of the administration of sequential~     drops, a combination drop and a combination spray for producing mydriasis and cycloplegia.~   "
235546|NCT00472511|"~     Attention-Deficit Hyperactivity Disorder (ADHD) is considered to be one of the most prevalent~     chronic health conditions in children. It affects between 4% and 12% of young children. A~     relationship between convergence insufficiency (eye teaming) and ADHD has been shown.~     However, the effect of ADHD medications on focusing and eye teaming has not been previously~     investigated. Therefore, the purpose of this study is to determine the effect of ADHD~     medication on focusing and eye teaming skills.~   "
235550|NCT00472459|"~     Patients on immunosuppressive therapy, e.g. organ recipients, have a higher occurrence of AK~     than the untreated population. Keratotic lesions (i.e. AK lesions and warts) in this~     population is highly associated with development of SCC also with 10 times higher mortality~     rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and~     BCC, increases with graft survival time and the length of immunosuppressive treatment period.~      The higher risk of developing skin malignancy and more aggressive skin malignancies in this~     population, indicate the need for early removal of these pre-malignant lesions.~      In this study, two contralateral areas (5x10 cm2) with skin lesions within the patient will~     be compared. One area will receive Metvix PDT at defined intervals and the other will receive~     lesion specific treatment at the discretion of the investigator. The primary end-point will~     be the accumulated number of new lesions during the study and number of AK lesions that show~     complete response 3 months after baseline. Secondary endpoints will be number of BCC lesions~     that show complete response, number of recurrent lesions, assessment of cosmetic outcome and~     safety.~   "
235551|NCT00472446|"~     The study investigates the impact on post-operative pain of the superficial cervical block~     with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid~     surgery under general anesthesia. In addition, cost savings using the cervical block are~     evaluated (due to reduced length of hospital stay).~      The study is prospective, randomized, double blind, and placebo-controlled. The study is~     performed at the Department of Surgery, Cantonal Hospital of St. Gallen.~   "
235552|NCT00472433|"~     The majority of cases of autoimmune cytopenias, which includes immune thrombocytopenia (ITP),~     autoimmune hemolytic anemia, autoimmune neutropenia (AIN) and pure red cell aplasia, will~     respond to conventional immunosuppressive therapy with or without splenectomy. There is,~     however, a group of patients with refractory or chronically relapsing autoimmune cytopenias~     causing life-threatening hemorrhages, infections or anemia. Further problems include the~     short- and long-term side-effects of corticosteroids, and the potential toxicity of~     immunosuppressive and cytotoxic agents. An alternative and less toxic approach in these~     patients may be the treatment with Campath-1H, a humanized IgG monoclonal antibody specific~     for the CD52 antigen and present on human lymphocytes and monocytes. The main effect of~     Campath-1H is on T cell and it results in a prolonged and profound depletion of the CD4 and~     CD8 subpopulations, particularly the CD4 population, and this might reset the immune system~     without the need for total immune ablation.Therefore, this study is designed to investigate~     safety and efficacy of repeated Campath treatment cycles in autoimmune cytopenia.In order to~     minimize possible side effects of accumulating Campath, the 3 treatment cycles will be~     administered in consecutively reduced doses.~   "
235553|NCT00472420|"~     This single arm study will evaluate the benefit of adding MabThera to standard induction~     chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and~     tolerability of a MabThera-containing first line regimen will also be assessed. All patients~     will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard~     chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample~     size is <100 individuals.~   "
235554|NCT00472407|"~     Measurement of near point of convergence (NPC) is often critical to the diagnosis of CI. This~     study will evaluate NPC measurements with commonly used target types.~   "
235555|NCT00472394|"~     New medical abortion regimens are being tested with increasing frequency. However women's~     preferences for certain attributes of the regimes are not being investigated to any great~     degree. Consideration of women's preferences in designing new regimens may help to optimize~     the medical abortion process. The proposed prospective survey research will attempt to~     determine women's preferences for individual aspects of medical abortion treatment and~     various regimens, and to determine what attributes of medical abortion treatment may be~     driving these preferences. The information collected in this study may be used in developing~     future treatment regimens or as the groundwork for future research into preferences,~     acceptability, and satisfaction with treatment.~   "
235556|NCT00472381|"~     Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor~     outcome. But the modalities of glucose lowering are still debated. This study will test the~     efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous~     insulin in acute ischemic stroke.~   "
235557|NCT00472368|"~     This single center study will help determine the absorption, metabolism, and excretion of~     LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom~     no standard therapy exists.~   "
235558|NCT00472355|"~     The purpose of this study is to determine if low doses of apomorphine worsen the motor~     symptoms of Parkinson's disease.~   "
235559|NCT00472342|"~     Many adipokines are thought that related with metabolic disturbance such as glucose~     intolerance, dyslipidemia, and insulin resistance. It is reported that regular physical~     training could prevent the progression of diabetes from prediabetes and improve the insulin~     resistance. After physical training, many adipokine levels were changed due to improving~     insulin resistance.~      In this study, we will examine the various adipokine levels such as adiponectin, RBP-4, and~     adrenomedullin after exercise training through exercise prescription in IFG and IGT patients.~   "
235560|NCT00472329|"~     Major Objectives A. To determine whether stable allogeneic hematopoietic engraftment can be~     safely established in patients who have rejected (<5% T Cell Chimerism) a previous allogeneic~     hematopoietic stem cell graft by using an allogeneic SCT from an HLA-Identical or~     non-identical family donor or unrelated donors, with fludarabine (150mg/m2) and TBI (400cGy),~     with post-transplantation immunosuppression utilizing tacrolimus and MMF.~      B. To evaluate the incidence of transplant related mortality.~      Minor Objectives A. To evaluate the incidence of acute and chronic GVHD after second~     allogeneic HCT utilizing Tac/MMF with peripheral blood stem cells from matched or mis-matched~     allogeneic donors.~      B. To evaluate disease responses and survival after second allogeneic SCT. C. To evaluate the~     need for DLI after second transplant for either disease control or persistent mixed~     chimerism.~   "
235572|NCT00472160|"~     Critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. For~     the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (NIV) is~     more effective at reducing arterial oxyhaemoglobin desaturation than standard method.~      Objectives: To find out whether NIV, as a preoxygenation method, is more effective at~     reducing the degree of organ dysfunction/failure than standard preoxygenation during the week~     following endotracheal intubation.~   "
235561|NCT00472316|"~     This study is designed as a cluster-randomized trial. The cluster unit is at the community~     level. Communities will be randomized to 1 of 2 study arms: DOTS+ACF or DOTS. Communities in~     the DOTS+ACF arm will receive door-to-door symptom screening of the entire population by~     health care workers between 2 and 4 times over a 9-month period. Those communities in the~     DOTS-arm will receive the current standard of care in those communities (PCF). All study~     communities will be receiving between 4 and 6 visits by community health workers annually as~     part of a program to assess and follow-up illnesses in each household. Households with ill~     residents will be visited more often. The intervention for this study is simply adding 3 to 5~     simple questions to the current protocol. For subjects responding positively to these~     questions, results will be returned to the subject at their home and routine, standard of~     care follow-up diagnostic and treatment algorithms will be followed.~   "
235562|NCT00472303|"~     The purpose of this study will be to determine whether tapentadol (CG5503) is effective and~     safe in the treatment of chronic tumor related pain compared to placebo. In addition~     tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as~     slow release (SR).~      *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to~     as extended release (ER) in the United States.~   "
235563|NCT00472290|"~     This is an open label extension study of romiplostim for treatment of thrombocytopenia~     (platelet count ≤ 50 x 10^9/L) in MDS subjects. The study is designed to assess the long-term~     safety of treatment with romiplostim, as measured by incidence of overall adverse events, the~     incidence of bleeding events, the utilization of platelet transfusions, and the duration of~     platelet response. The study will further describe the time to disease progression to acute~     myeloid leukemia (AML) and survival.~   "
235564|NCT00472264|"~     It is hypothesised that there is a difference between the uptake of a radioactive substance~     ([18F]fluorodeoxyglucose (FDG)) in the lungs of patients with Chronic Obstructive Pulmonary~     Disease (COPD) and healthy volunteers.~   "
235565|NCT00472251|"~     It is widely-accepted that serum testosterone level and BMI (body mass index) representative~     of the degree of obesity has negative correlation. Considering the fact that obesity is being~     mentioned as a risk factor for development of prostate cancer as well as other various~     life-threatening diseases (example: cardiovascular problems), the effect of BPH treatment~     agents on BMI is a subject that should certainly be elucidated. Meanwhile, to our knowledge,~     no prospective study has so far been performed on such issue in Asian population. Prior to~     generating hypothesis of the effect of 5 alpha reductase inhibitor on BMI, the real effect of~     5 alpha reductase inhibitor on BMI change in Korean BPH patients has to be observed in real~     clinical practice. This study will test the effects of one-year medication of 5 alpha~     reductase inhibitor on BMI among Korean men with BPH.~   "
235566|NCT00472238|"~     A severely reduced left ventricular ejection fraction is associated with increased mortality~     due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that~     targeted training may lead to improved survival and to increased parameters of risk~     stratification for malignant arrhythmia. Additionally, the training may lead to an improved~     psychological and mental condition of the patients~   "
235567|NCT00472225|"~     Chronic GVHD is the most common late complication following allogeneic stem cell~     transplantation. It has features resembling autoimmune disorders such as scleroderma, primary~     biliary cirrhosis, bronchiolitis obliterans, chronic immunodeficiency etc. Thus, chronic GVHD~     can lead to debilitating complications such as joint contractures, blindness, end-stage lung~     disease, etc so that chronic GVHD has a major impact both on survival as well as quality of~     life. Although its pathogenesis is still poorly unclear, it has been reported since 2000 that~     B cell-mediated immunity may also contribute to development of chronic GVHD other than T~     cells. Thus, targeting against B cell may be a useful treatment strategy in the treatment of~     chronic GVHD.~      The purpose of this study is to determine whether rituximab, an anti-CD20 monoclonal kimeric~     antibody is effective in the treatment of chronic graft-versus-host disease (chronic GVHD)~     refractory to steroid.~   "
235568|NCT00472212|"~     Hyperopia (farsightedness) has been reported to be associated with reduced visual perceptual~     and reading abilities. However, there is controversy regarding whether or not to prescribe~     for low to moderate amounts of hyperopia. The Correction of Hyperopia In Children Study~     (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle~     correction for moderate amounts of hyperopia on visual function, symptoms, attention, and~     reading skills in children.~   "
235569|NCT00472199|"~     The primary objective of the current study will be the evaluation of long-term efficacy of a~     26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless~     Legs Syndrome (RLS) in comparison to placebo.~      The key secondary objectives are to assess the effects on clinical global impressions -~     global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS~     responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary~     objectives are to investigate the incidence and severity of augmentation and rebound and to~     assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS~     symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the~     IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS~     (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on~     safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.~   "
235570|NCT00472186|"~     This study was designed to determine whether post-operative pain following a tonsillectomy~     can be reduced by adding an antacid-like medication to the medications taken after surgery.~     It is hypothesized that even a small amount of stomach acid backing up and entering the mouth~     can increase post-tonsillectomy pain. Therefore, the use of an antacid-like medication should~     help to decrease pain and reduce the amount of narcotic medication required for pain control.~   "
235571|NCT00472173|"~     Pulp necrosis is one of the main complication of dental trauma. When it happens on an~     immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy~     called apexification is required to induce the formation of a calcified apical barrier~     allowing a permanent and hermetic root filling.The aim of this study is to compare the~     efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the~     reference treatment based on calcium hydroxide repeated stimulations.~   "
235573|NCT00472147|"~     Sudden cardiac death is the most frequent cause of death in industrialized countries. The~     most efficient interventiont in ventricular fibrillation is defibrillation in an appropriate~     timely manner. But since the intervention of defibrillation the optimal shock energy is~     unknown. As a too low energy is not able to terminate ventricular fibrillation a too high~     energy may cause asystole wich jeopardizes survival itself. We study the efficacy of~     different shock energies on the termination of ventricular fibrillatiion and survival.~   "
235574|NCT00472134|"~     The purpose of this study is to determine the effects of a local anesthetic dispensed via a~     tiny catheter device, called the ON-Q PainBuster pump, placed during surgery on top of the~     mesh used in the laparoscopic repair of ventral hernias. The goals are:~        -  reducing postoperative pain from this procedure~        -  decreasing length of hospital stay~        -  reducing or eliminating amount of post-operative narcotics used~   "
235575|NCT00472121|"~     The purpose of the study is the examine the precision of acceleromyography and~     mechanomyography during recovery from a neuromuscular blocking agent and to examine whether~     there is any difference in monitoring block at the dominant or non-dominant arm. Our~     hypothesis is that there is no significant difference in neither the precision nor the level~     of block in the contralateral arms.~   "
235576|NCT00472108|"~     Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light~     activation of a photosensitiser in the presence of oxygen. These cells accumulate more~     photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon~     illumination.~      For skin diseases, there has been an increasing interest in using precursors of the~     endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have~     been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix, contains~     the methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity.~      In vitro studies of animal and human tissues have shown significant intracellular formation~     of photoactive porphyrins after addition of Metvix. The increased photoactive porphyrins~     levels induced cytotoxic effects in tumour cells after photoactivation.~      The primary objective is to compare PDT with Metvix cream to PDT with placebo cream in terms~     of patient complete response rates based on histologically verified disappearance of the~     lesions at 6 months after last treatment cycle. Secondary objectives are to compare the two~     treatments in terms of histological and clinical mean patient response weighted by the number~     of lesions within a patient, lesion response rates across patients, clinical complete patient~     response, cosmetic outcome and adverse events.~   "
235577|NCT00472095|"~     Diabetes with poor sugar control can lead to blindness, heart attacks, and amputations.~     Latinos are more at risk for diabetes. A fotonovela is a type of comic book commonly read by~     Latinos that might be a way to teach them about the risk of high sugars. The researchers will~     give patients either a fotonovela about diabetes or one with nothing to do with diabetes.~     Then they will compare how well sugars were controlled afterward in each group. This way they~     can see if these fotonovelas were useful.~   "
235578|NCT00472082|"~     The toxicity of calcineurin inhibitors(CNI)is a major factor limiting the success of renal~     transplantation. This protocol aims to replace the calcineurin inhibitor, tacrolimus, with~     efalizumab early after transplantation in patients with mild impairment of renal function in~     order to minimize the toxicities of CNI.~   "
235579|NCT00472069|"~     Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter~     insufficiency and results in a dramatic deterioration of the quality of life. We developed a~     new therapeutic strategy for stress urinary incontinence based on the implantation myofibers~     with their satellite cells in the urethra. The aim of this procedure is to generate~     functional tissue acting like a new sphincter in the urethra~   "
235580|NCT00472056|"~     Cohort 1: Patients who are less than or equal to 65 years of age.~      1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose~     rituximab)~      Cohort 2: Patients who are older than 65 years of age~        1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high~          dose rituximab)~        2. To determine the treatment related mortality (TRM)~   "
235581|NCT00472043|"~     Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light~     activation of a photosensitiser in the presence of oxygen. These cells accumulate more~     photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon~     illumination.~      For skin diseases, there has been an increasing interest in using precursors of the~     endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have~     been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®,~     contains the methyl ester of ALA, which penetrates the lesions well and shows high lesion~     selectivity .~      In vitro studies of animal and human tissues have shown significant intracellular formation~     of photoactive porphyrins after addition of Metvix®. The increased levels of photoactive~     porphyrins induced cytotoxic effects in tumour cells after photoactivation.~      The primary objective is to compare PDT with Metvix® cream to PDT with placebo cream in terms~     of patient complete response rates based on histologically verified disappearance of the~     lesions at 6 months after last treatment cycle.~      Secondary objectives are to compare the two treatments in terms of histological and clinical~     mean patient response weighted by the number of lesions within a patient, lesion response~     rates across patients, clinical complete patient response, cosmetic outcome and adverse~     events.~   "
235582|NCT00472030|"~     The primary objective is to test the safety and efficacy of Xolair in the treatment of the~     autoimmune blistering disease, bullous pemphigoid (BP).~      This is a pilot, open label case-control study. Patients treated with Xolair will be compared~     to patients receiving standard treatment with prednisone.~      The enrollment period for the study is 24 weeks: 16 weeks active treatment and 8 additional~     weeks of observation.~   "
235583|NCT00472017|"~     This phase I trial is studying the side effects and best dose of vandetanib when given~     together with radiation therapy in treating young patients with newly diagnosed diffuse brain~     stem glioma.~   "
235584|NCT00472004|"~     This is a Phase IV prospective, randomized, open label, comparative, multicenter study in~     generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and~     Livial (Tibolone).~   "
235585|NCT00471991|"~     The aim of this monocenter, open-label, randomized study is to determine the ovulation~     inhibitory effect of the combined oral contraceptive (COC) SH T04769G and to collect~     supplementary data regarding the ovulation inhibitory effect of the COC Valette® SH D00659AF~     (0.03 mg EE and 2.0 mg DNG), each applied for two treatment cycles in 60 healthy female~     volunteers, aged 18-35 years.Combined oral contraceptives consist of two components: an~     estrogen and a progestin. The estrogen is required for a regular cycle; the progestin ensures~     the protection against unwanted pregnancy. In a sufficient dosage, progestins prevent~     ovulation. The investigational product is an oral contraceptive that contains the estrogen~     ethinylestradiol and the progestin dienogest as active ingredients. 21 tablets are taken each~     cycle followed by a 7-day tablet-free interval. Thus, the whole cycle lasts for 28 days.The~     marketed oral contraceptive Valette® contains both ingredients (ethinylestradiol and~     dienogest) in a higher dose. One half of the volunteers (30 volunteers) will receive this~     product. Efficacy and safety were already confirmed by numerous clinical studies.Another 30~     volunteers will receive the investigational product. The dose reduction is not assumed to~     have a negative impact on tolerance.The study is aimed to show whether the reduced dosage is~     sufficient for contraception.Course of the study:The study consists of 4 cycles (one cycle~     before treatment, followed by two treatment cycles and one post-treatment cycle) resulting in~     approx. 16 weeks of study participation. The post-treatment cycle is aimed to observe the~     return to the normal function of the ovaries. Volunteers will have to come for a visit every~     2 to 4 days over the whole study period.Visit 1The investigator will explain the study in~     detail and the volunteer will be given ample time and opportunity to ask questions. If all~     questions were answered the volunteer will decide on participation in the study. If she~     decides to take part, she will give her written consent on the Informed Consent~     Form.Afterwards, a pregnancy test will be performed, a complete medical, surgical and~     medication history will be recorded and physical and gynaecological examinations will be~     performed. Transvaginal ultrasonography will be done and smear from the mouth of the uterus~     is taken for precaution of cancer.Blood (10 ml) will be drawn to determine routine safety~     lab, heart rate and blood pressure will be measured and height and weight will be~     recorded.Volunteers will be provided with a diary that has to be filled in on a daily basis~     during the whole study period (bleeding records, intake of study medication, performance of~     pregnancy tests).During the whole study non-hormonal methods of contraception have to be used~     (condom plus spermicide; diaphragm with spermicide). During the cycle before study treatment,~     the function of the ovaries is studied by transvaginal ultrasonography and determination of~     hormonal parameters from blood samples. The mouth of the uterus is inspected during each~     visit and the cervical smear will be investigated. Visits will be performed every 4 days.If~     ovulation can be confirmed, volunteers will be randomized to one of the treatment~     groups.Volunteers who will receive the investigational product will undergo a blood sampling~     on a given day of this cycle to determine the baseline hormonal status (fasting condition).A~     home pregnancy test has to be done by the volunteer before intake of the study medication.~     Only in case a pregnancy is excluded, intake of study medication will start.Treatment~     cycles:During these cycles, visits are performed every 3 days to determine ovarian activity~     (transvaginal ultrasonography, blood sampling, inspection of the mouth of the uterus and~     cervical smear investigation). Adverse events will be recorded and diary entries will be~     controlled by the investigator.Volunteers who receive the investigational product have to~     undergo a series of blood sampling during the 2nd treatment cycle to evaluate the~     pharmacokinetic (liberation, absorption, distribution, metabolization and excretion) of the~     new oral contraceptive.Post-treatment cycle:Non-hormonal contraceptive methods have also to~     be used during the post-treatment cycle. It starts immediately after the 2nd treatment cycle,~     i.e., on the 8th day after the last tablet intake and ends with the start of the next~     menstrual bleeding. Visits will be performed every 4 days to determine the return of ovarian~     activity by transvaginal ultrasound measures and blood sampling for hormone determination.~     After end of the next menstrual bleeding, a final Visit including physical and gynaecological~     examinations will be performed. Options for further contraceptive methods will be discussed~     with the investigator.~   "
249522|NCT00286429|"~     The purpose of this study is to determine the efficacy and safety of alogliptin, once daily~     (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.~   "
235586|NCT00471978|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help the study of cancer in the future.~      PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients~     with lung cancer.~   "
235587|NCT00471965|"~     Primary:~        -  Overall Survival (OS)~      Secondary:~        -  Time to Tumor Progression (TTP)~        -  Response Rate (RR)~        -  Improvement of Quality of Life (QoL)~        -  Safety~        -  Secondary resection rate~   "
235588|NCT00471952|"~     The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with~     caffeine for treating acute attacks of migraine.~      Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will~     be dispensed one box containing 3 packets of study medication labeled for Headache #1,~     Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt~     placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing~     placebo (sugar).~      One headache will be treated with a combination of Maxalt 10mg MLT and caffeine.~      Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule~     containing placebo.~      A third headache will be treated with just placebo.~      Neither the subject, the study coordinator, or your study doctor will know in which order you~     will receive the three different treatments. This information is available in case of~     emergency.~   "
235589|NCT00471939|"~     This is a phase II, multi-centre, controlled study comparing the safety and tolerability on~     wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB~     versus staples applied in the same patient to burn areas requiring autologous meshed skin~     grafting.~   "
235590|NCT00471926|"~     In order to assess more completely the levels of diabetes care delivered in Taiwan, we now~     have nationally standardized performance measures that can evaluate quality of diabetes care~     accurately and reliably. These performance measures were seriously reviewed and discussed in~     the aspects of their practicability, feasibility and compliancy, through a series of~     nation-wide consensus meetings by a number of multidisciplinary professionals of Taiwan~     Diabetes Care Teams ( TDCTs ), before delivering into the clinical settings ( 10 ).~      Conceptually, these measures will enhance uptake of research into practice and may ultimately~     improve diabetes care and clinical outcomes. Along with the serial developments mentioned~     above, the BNHI ( the sole healthcare insurance organization in Taiwan ) has been fully~     involved, from the very beginning, in the formation and development of these performance~     measures which have totally been included in the development of the Diabetes Case Management~     Program ( DCMP ) 2001 later on. The DCMP 2001 is a unique program that has been delivered~     into the nation-wide clinical practices since Dec. 2001 in Taiwan. It has linked the quality~     of diabetes care to the monthly income ( reimbursed from BNHI ) of the registered clinical~     diabetes educators ( i.e., physicians, nurses and dietitians ) for enhancing and assuring the~     complete implementation of these performance measures in diabetes care. It has been~     recognized that a consensus on measures at national level could provide a method for~     assessing care within and across healthcare settings while providing a meaningful mechanism~     for quality improvement. In this proposal, we are going to develop the Diabetes Quality~     Improvement Program ( DQIP ) based on the DCMP 2001 in Taiwan.~      Initially, we are going to establish the continuous diabetes quality monitoring system and~     then to evaluate the (1) the lifestyles and eating habits and dietary compositions in type 2~     diabetes mellitus (2)The relationships between lifestyles and eating habits and dietary~     compositions in diabesity.~   "
235591|NCT00471913|"~     Study focus is femoral shaft (thigh bone) fractures (break) that require surgical treatment~     under anaesthetic to stabilize the femur fracture. This is usually done by placing a metal~     nail and screws inside the femur (thigh) bone.~      This study has been designed to allow us to learn more about the effect of using a different~     starting point to insert the nail into the body in order to access the fracture and fix it.~     This question is important because to date, all entry points currently used do result in some~     muscle damage. In order to minimize this damage a lateral (side) entry nail has been~     developed and is currently in use at many centres. This nail is new but, the lateral entry~     technique for these types of fractures has been used extensively in the past, and this nail~     has been developed in order to better accommodate the technique.~      It is believed that entering laterally instead of going deeper into the tissue to access the~     bone to fix it is going to result in less muscle damage which in turn will improve functional~     outcome.~   "
235592|NCT00471900|"~     DHEA is an adrenal deriven androgen precourser. The impact of DHEA substitution therapy in~     adrenal failure is unknown as well as the physiologically effects of DHEA is unknown. Effects~     of physiologically DHEA substitution is investigated in the model of female adrenal failure.~   "
235593|NCT00471887|"~     RATIONALE: Monoclonal antibodies, such as ticilimumab (CP-675,206), can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying how well ticilimumab (CP-675,206) works in treating~     patients with stage IIIC or stage IV melanoma.~   "
235594|NCT00471874|"~     The purpose of this study is to determine in Australia what effect rheumatoid arthritis has~     on quality of life, and also to determine the costs that are associated with having~     rheumatoid arthritis.~   "
235595|NCT00471861|"~     The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in~     patients with active migraine headaches. Secondary goal is to determine whether other~     inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal~     Polypeptide (VIP) or Substance P (SP) are elevated in patients having a migraine headache.~   "
235596|NCT00471848|"~     To assess the tolerability and effectiveness of rabbit antithymocyte globulin (ATG,~     Thymoglobuline) with ciclosporin in the first line treatment of patients with acquired severe~     aplastic anaemia, and patients with non-severe aplastic anaemia and who are transfusion~     dependent.~   "
235597|NCT00471835|"~     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic~     body radiation therapy and to see how well it works in treating patients with stage I or~     stage II non-small cell lung cancer.~   "
235598|NCT00471822|"~     Primary Objective: Evaluation of the~      - Carriage rate of Streptococcus pneumoniae in the nasopharynx of children~      Secondary Objective:~        -  Carriage rate and distribution of Streptococcus pneumoniae serotypes~        -  Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains~        -  Distribution of Staphylococcus aureus strain~        -  The influence of risk factors in the Streptococcus pneumoniae carriage rate in children~   "
235659|NCT00471016|"~     This project is a prospective, randomized controlled trial to improve the end of life~     experience for homeless persons by facilitating the expression of their wishes and~     enhancement of their dignity when facing serious illness, death, or the prospect of dying.~     Our main hypothesis is that homeless persons will engage in this intervention and increase~     rates of advance directive completion.~   "
235599|NCT00471809|"~     The MARS trial is a randomized, double-blind, parallel group study that compares the capacity~     of azithromycin or montelukast to placebo as effective adjunctive therapy that allows~     reduction of inhaled corticosteroids in children ages 6 to 17 years with moderate to severe~     persistent asthma. The primary null hypothesis is that in children with moderate-to-severe~     persistent asthma, a macrolide antibiotic (azithromycin) or a leukotriene receptor antagonist~     (montelukast) will provide a steroid-sparing effect when compared to placebo as the dose of~     inhaled corticosteroid is reduced. This will be tested following achievement of control of~     symptoms with moderate to high-dose inhaled corticosteroid in combination with a long-acting~     bronchodilator agonist. Use of these doses for the inhaled corticosteroid will be based on~     NHLBI step-up guidelines to achieve asthma control.~   "
235600|NCT00471796|"~     There is supposed that patients with functional esophageal disorders such as functional~     heartburns and functional chest pain have common underlying mechanisms of symptom generation.~     These include esophageal dysmotility, non-acidic gastro-esophageal reflux,~     duodeno-gastro-esophageal reflux, esophageal hypersensitivity, and psychological comorbidity.~      The treatment of these patients is the growing challenge in the primary care medicine and in~     the gastroenterological practice. It was postulated that functional disorders of the~     esophagus are the main reason for PPI failure in patients with heartburn.~      The aim of the study is to evaluate the role of biofeedback in the treatment of patients with~     functional chest pain and functional heartburns.~   "
235601|NCT00471783|"~     To determine if flossing with a dental floss presoaked in chlorhexidine, an anti-microbial~     mouth wash, would improve the clinical signs of gingivitis, an inflammation of the gums~     characterized by red, swollen, bleeding gums. And to determine if applying chlorhexidine via~     dental floss would result in tooth staining, which is common with chlorhexidine mouthwashes.~   "
235602|NCT00471770|"~     To determine the proportion of hospitalized pneumonia cases in children aged 60 months or~     less associated with vaccine-preventable Streptococcus pneumoniae serotypes (4, 6B, 9V, 14,~     18C, 19F, 23F).~   "
235603|NCT00471757|"~     The proposed study aims to provide current information, etiology and outcome of~     community-acquired pneumonia (CAP), risk factors for for CAP in isolates of Streptococcus~     pneumoniae and Haemophilus influencae, Mycoplasma pneumoniae, chlamydia pneumoniae and~     Legionella. Risk factors, including patient demographics, comorbid illnesses, setting of~     presentation, causative organisms, antibiotic history, and resistance profiles will be~     assessed and outcome will be recorded.~   "
235604|NCT00471744|"~     The investigators hypothesize that Levetiracetam is as effective as Sulthiame in the~     treatment of children with BECTS. Patients entering the HEAD-Studie are either treated with~     Leveitracetam or Sulthiame over a 6 months period. Patients are equally randomised to one of~     the two treatment regimens. Administration of medication as blinded capsules.~   "
235605|NCT00471731|"~     Premature ovarian failure (POF) is known to be associated with an increased risk of ocular~     surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen~     in this condition. From preliminary data, we suspect that women with Turners syndrome (45,~     XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of~     ocular surface disease. Comparing POF and TS women may allow us to distinguish different~     mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen~     and androgen) alterations posed by POF and TS.~   "
235606|NCT00471718|"~     RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-751 and to~     see how well it works in treating patients with metastatic prostate cancer that did not~     respond to hormone therapy.~   "
235607|NCT00471705|"~     Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown~     an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000~     new cases of CL were diagnosed in Colombia.~      So far, pentavalent antimony compounds have been considered the treatment of choice with a~     percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by~     their adverse events and disadvantages. Previous studies have shown that miltefosine could be~     a potential alternative of treatment for CL.~      The main objective of this study is to evaluate the efficacy and safety of miltefosine or~     thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of~     miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50~     celsius degrees during 30 seconds will be compared with the standard treatment of~     intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days~     in CL parasitologically proven patients.~      This trial will be conducted according to the International approved GCP (Good Clinical~     Practice) guidelines.~   "
235608|NCT00471692|"~     Inguinal hernia repair is a common surgical procedure. The major current debates revolve~     around laparoscopic hernia repair. The most recent Cochrane review concluded that~     laparoscopic inguinal hernia repair was associated with less post operative and chronic pain,~     shorter convalescence and earlier return to work when compared to open repair (McCormack K,~     Scott NW, Go PM, Ross S, Grant AM. EU hernia trialist collaboration. Laparoscopic techniques~     versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev 2003;~     1(CD001785.). However, laparoscopic repair has not gained wide acceptance. It is more~     expensive, technically difficult for the inexperienced surgeon, is associated with rare but~     potentially more hazardous procedure related complications (Lo CH, Trotter D, Grossberg P.~     Unusual complications of laparoscopic totally extraperitoneal inguinal hernia repair. ANZ~     journal of Surgery 2005 Oct, 75(10): 917 - 919.) and unlike open repair, requires a general~     anaesthetic. Critics state that laparoscopic repair is not suitable for all general surgeons~     and should be restricted to experts. Two prospective studies have shown that a longer~     laparoscopic learning curve exists when compared to open surgery. Up to 200 laparoscopic~     procedures are required to achieve a recurrence rate comparable to open mesh repair. (Bittner~     R, Schmedt CG, Schwarz J, Kraft K, Leigl BJ. Laparoscopic transperitoneal procedure for~     routine repair of groin hernia British journal of Surgery 2002 89; 1062 - 1066.) A~     meta-analysis and large multicentre randomised study have added to these concerns by~     demonstrating a higher recurrence rate with laparoscopic repair. (Memon MA, Cooper NJ, Memon~     B, Memon MI, Abrams KR. Meta-analysis of randomised controlled trials comparing open and~     laparoscopic inguinal hernia repair. British journal of Surgery 2003; 90: 1479 - 1492.~     Neumayer L, Giobbie-Hurder, Jonasson O, Fitzgibbons R, Dunlop D, Gibbs J et al. Open mesh~     versus laparoscopic mesh repair of inguinal hernias. New England Journal of Medicine 2004;~     350: 1819 - 1827.). Over the period 1998 to 2003, in Denmark, the frequency of laparoscopic~     repair remained constant at 4.5 - 8.0%, the laparoscopic approach being used more frequently~     for bilateral hernia repairs and recurrent hernia repairs. There was a higher re-operation~     rate following laparoscopic repair of bilateral inguinal hernias compared to bilateral open~     hernia repair. (Wara P, Bay-Nielsen M, Juul P, bendix J, Kehlet H. Prospective nationwide~     analysis of laparoscopic versus Lichenstein repair of inguinal hernia. British Journal of~     Surgery 2005 92(10); 1277 - 1281.)~      Given these issues, a considerable number of adult inguinal hernia repairs will continue to~     be performed using the open technique. There is the opportunity to improve the results of~     open repair by potentially improving post operative pain and chronic pain. One method may be~     to perform an ilio inguinal nerve block. However, this procedure can be complicated by~     femoral nerve palsy, colonic or small bowel puncture and pelvic haematomas (Johr M, Sossai R.~     Colonic puncture during ilioinguinal nerve block in a child. Anesth Analg 1999 88 1051 -~     1052, Amory C, mariscal A, Guyot E et al. Is ilioinguinal/iliohypogastric nerve block always~     totally safe in children? Paediatr Anaesth 2003; 13: 164 - 166. Vaisman J. Pelvic hematoma~     after an ilioinguinal nerve block for orchialgia Anesth Analg 2001 92 1048 - 1049. Notaras~     MJ. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve blockade for~     inguinal herniorrhaphy. British Journal of Surgery 1995 82: 854. Rosario DJ, Skinner PP,~     Raftery AT. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve~     blockade for inguinal herniorrhaphy. British journal of Surgery 1994 81: 897. Ghani KR,~     McMillan R, Paterson-Brown S. Transient femoral nerve palsy following ilio-inguinal nerve~     blockade for day case inguinal hernia repair. J R Coll Surg Edinb 2002; 47: 626 - 629. Erez~     I, Buchumensky V, Shenhman Z, et al. Quadriceps paresis in pediatric groin surgery. Pediatr~     Surg Int 2002; 18: 157 - 158, Vironen J, Neiminen J, Eklund A, Paavolainen P. Randomised~     clinical trial of Lichtenstein patch or prolene hernia system for inguinal hernia repair.~     British Journal of Surgery 2006; 93: 33 - 39)), resulting in delayed discharge of patients.~     It also has a failure rate of 20 - 30% (Lim SL, Ng SB, Tan GM. Ilioinguinal and~     iliohypogastric nerve block revisited; single shot versus double shot technique for hernia~     repair in children. Paediatr Anaesth 2002; 12; 255 - 260.) The aim of our study is therefore~     to assess the role of ilio inguinal nerve block in adult patients undergoing primary inguinal~     hernia repair.~   "
235609|NCT00471679|"~     RATIONALE: Ethanol-lock treatment may help prevent central venous catheter infections in~     patients with high-risk neuroblastoma.~      PURPOSE: This phase I trial is studying the side effects of ethanol-lock treatment in~     preventing central venous catheter infections in patients with high-risk neuroblastoma.~   "
235610|NCT00471666|"~     This study will examine the clinical, immunological and epidemiological effects of concurrent~     infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause~     malaria and filariasis) on the frequency and severity of malaria infection in children and~     young adults in Mali, Africa.~      Residents of Tien gu bougou and Bougoudiana, Mali, who are between 1 and 20 years of age may~     be eligible for this study. Participants with and without filarial infection will be~     enrolled.~      Participants undergo the following tests and procedures:~        -  Baseline evaluation with medical history and physical examination, blood tests and stool~          culture~        -  Brief physical examinations weekly~        -  Blood tests monthly for malaria~        -  Standard treatment offered for anyone with malaria~        -  Blood tests for filarial infection at the beginning, midpoint and end of the~          transmission season~        -  Treatment for lymphatic filariasis is available through the National Program for the~          Elimination of Lymphatic Filariasis. There is no effective standard therapy for M.~          perstans.~        -  Treatment for other parasitic worm infections, if needed.~   "
235660|NCT00471003|"~     The main purpose of this study is to asses the efficacy and safety of telmisartan, with the~     special attention on the influence of telmisartan on selected metabolic parameters of~     patients.~   "
235611|NCT00471653|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving temozolomide~     may help doctors learn how temozolomide works in the body. It may also help doctors learn~     more about how a patient's genes may affect the risk of developing thrombocytopenia.~      PURPOSE: This clinical trial is studying the pharmacokinetics in patients with newly~     diagnosed high-grade glioma receiving temozolomide and radiation therapy.~   "
235612|NCT00471640|"~     The purpose of this study is to determine whether dexamethasone reduces the length of~     hospital stay in patient with a community-acquired pneumonia.~   "
235613|NCT00471627|"~     Previously we have demonstrated in animal experiments,that pancreas is extremely vulnerable~     to handling, reacting with the development of pancreatitis. In human pancreatic surgery,~     post-operative pancreatitis mediates many other post-operative complications. A new~     anastomosis was developed to diminish the injury, as being without any stitches going through~     the pancreas. The aims were to study up to 30 patients as phase one study, with an interim~     analysis in this open uncontrolled trial after the first few patients.~   "
235614|NCT00471614|"~     The purpose of this study is to determine whether uridine supplementation will improve~     insulin sensitivity and overall carbohydrate metabolism in HIV-positive subjects who are~     currently undergoing treatment with antiretroviral regimens containing stavudine or~     zidovudine and who have evidence of impaired mitochondrial function and insulin resistance.~   "
235615|NCT00471601|"~     RATIONALE: A questionnaire that evaluates a patient's expectations about breast~     reconstruction surgery may help doctors improve patient education before surgery and increase~     patient satisfaction after surgery.~      PURPOSE: This clinical trial is developing a questionnaire to evaluate patient expectations~     for breast reconstruction in women with breast cancer or other conditions.~   "
235616|NCT00471588|"~     3 groups of subjects (healthy controls, OCD subjects and stimulant-dependent subjects) will~     receive pramipexole (1.5 mg, single dose), amisulpride (400 mg, single dose) or placebo in a~     cross-over, double-blind, placebo-controlled design.~      Effects of compulsive behaviour will be assessed using fMRI and cognitive testing.~      Assess biomarkers including cardiovascular responses and plasma levels. All groups studied on~     3 separate occasions following screening, with at least a week intervening between~     consecutive assessments. The procedures to be adopted for study assessment will be identical~     on each occasion.~   "
235617|NCT00471575|"~     Non alcoholic fatty liver disease (NAFLD) is one of the main causes of development of chronic~     liver disease and cirrhosis. There are no published studies which have investigated the~     incidence of NAFLD in pregnant women or the correlation between the metabolic changes in~     pregnancy and this phenomenon.~      We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography (US)~     during the end of the pregnancy or immediately after birth (after 36 weeks) and to look for a~     correlation between fatty liver and demographic, clinical, nutritional and laboratory data~     during pregnancy.~   "
235618|NCT00471562|"~     RATIONALE: Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to~     the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of angiotensin-(1-7)~     in treating patients with metastatic or unresectable solid tumors.~   "
235619|NCT00471549|"~     Diabetes is associated with dyslipidaemia leading to generalized atherosclerosis,~     cardiovascular disease (CVD) and nephropathy. Osteoprotegerin (OPG), a glycoprotein involved~     in bone homeostasis, has been implicated in the pathogenesis leading up vessel calcification.~     Furthermore, CVD in diabetics is associated with increased levels of OPG.~      Aim: To investigate whether low dose simvastatin treatment (10-20 mg/day) reduces circulating~     levels of OPG as well as adhesion molecules (VCAM-1; vascular cell adhesion molecule-1, ICAM;~     intercellular cell adhesion molecule).~   "
235620|NCT00471536|"~     This phase II trial is studying the side effects and how well pazopanib works in treating~     patients with metastatic urothelial cancer. Pazopanib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
235621|NCT00471523|"~     Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in~     patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound~     between them should be initially administered. The aim of the study will be to compare in a~     clinical setting the efficacy of CC and metformin as first-line approaches for treating~     anovulation in infertile PCOS patients.~   "
235622|NCT00471510|"~     The purpose of this study is to evaluate the safety and efficacy of three doses of topical~     NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center~     of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized~     treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101~     2.0% or placebo. A 12-week observation period will follow the treatment period.~   "
235623|NCT00471497|"~     In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg~     twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients~     with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase~     (CML-CP).~   "
235624|NCT00471484|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, doxorubicin, and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells.~     Giving combination chemotherapy together with interferon alfa may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with interferon alfa-2b works in treating patients with nonmetastatic liver cancer that~     cannot be removed by surgery.~   "
235625|NCT00471471|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete~     Freund's adjuvant may make a stronger immune response and kill more tumor cells.~      PURPOSE: This clinical trial is studying the side effects and how well vaccine therapy works~     in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by~     surgery.~   "
235626|NCT00471458|"~     Previous studies of hyperthyroid patients suggest that they remain at increased risk of~     cardiovascular morbidity after restoring euthyroidism.~      The study objective is to compare the rate and causes of hospitalization of hyperthyroid~     patients treated with radioactive iodine (RAI) with those of an age- and gender-matched~     reference population in a long-term follow-up study.~   "
235627|NCT00471445|"~     RATIONALE: Topical cream containing amitriptyline and ketamine may help relieve pain,~     numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether~     topical amitriptyline and ketamine cream is more effective than a placebo in treating~     peripheral neuropathy caused by chemotherapy.~      PURPOSE: This randomized phase III trial is studying the side effects and how well topical~     amitriptyline and ketamine cream work compared with a placebo in treating peripheral~     neuropathy caused by chemotherapy in patients with cancer.~   "
235628|NCT00471432|"~     RATIONALE: OGX-011 may kill tumor cells by blocking some of the proteins that may cause tumor~     cells to grow. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving OGX-011 together with docetaxel may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of OGX-011 when given~     together with docetaxel in treating patients with metastatic or locally recurrent solid~     tumors.~   "
235629|NCT00471419|"~     The purpose of this study is to see if Rimexolone (FID 109980) is a safe and effective~     treatment of dry eye.~   "
235630|NCT00471406|"~     Purpose: To investigate the efficacy of photodynamic therapy with verteporfin for the~     treatment of patients with corneal neovascularization.~      Design: Prospective, non-comparative case series. Participants: Eighteen eyes of 18 patients~     with stable corneal neovascularization who were refractory to conventional treatment.~      Methods: The patients were treated with photodynamic therapy with verteporfin (6 mg/m2). Five~     patients were treated following penetrating keratoplasty, and 2 patients were treated before~     penetrating keratoplasty. Best corrected visual acuity and anterior segment photography were~     performed before and after treatment. The length of cumulative blood vessels and area of~     corneal neovascularization were measured.~      Main outcome measures: Vascular occlusion, best corrected visual acuity, cumulative blood~     vessel length, and corneal neovascularization area.~   "
235631|NCT00471393|"~     The use of a topical medication was compared to placebo to be applied over the symptomatic~     temporomandibular joint in women with the diagnosis of osteoarthritis of the~     temporomandibular joint(s).~      The hypothesis is to investigate whether the use of a topical anti-inflammatory medication~     when compared to the placebo would decrease the pain of the affected joint and/or increased~     mouth opening.~   "
235632|NCT00471380|"~     Double blind, crossover randomized, multicentric study to compare efficacy and tolerability~     of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed~     combination in patients with glaucoma or ocular hypertension~   "
235633|NCT00471367|"~     This study has two parts (A and B). The primary purpose of Part A is to find the maximum~     tolerated dose is for an experimental drug called AZD4877 based on the side effects~     experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an~     additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is~     an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading~     to tumor growth~   "
235634|NCT00471354|"~     The purpose of the study is to investigate the relationship of changes in measures of~     academic performance and problem behaviors, to changes in core~     Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with~     atomoxetine.~   "
235635|NCT00471341|"~     This study involves a drug called celecoxib, which is commonly prescribed for people with~     arthritis. Arthritis is caused by inflammation of the joints or tissues. Inflammation also~     occurs in the blood vessels that lead to your heart, and the purpose of this study is to see~     if celecoxib can reduce the blood vessel inflammation associated with high cholesterol and~     heart disease.~   "
235636|NCT00471328|"~     The study evaluated the safety and efficacy of nilotinib versus current treatment in adults~     with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant~     to the first and second line treatments.~   "
235637|NCT00471315|"~     Open-label single center study of duloxetine in patients with SOD who have failed to respond~     to the standard treatments.~      This protocol is designed to explore the tolerability and efficacy of Duloxetine in the~     management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).~   "
235638|NCT00471302|"~     This study will determine the immune response to malaria infection in healthy volunteers~     compared with malaria patients. Malaria affects millions of people in Mali and Africa. It can~     cause fever, headaches, body aches, and weakness. Without treatment, the disease can be very~     serious in children. Developing an effective vaccine against the parasite that causes malaria~     is a crucial step toward controlling the disease; however, vaccines tested so far have~     provided very short-lived protection. A better understanding of the natural immunity to~     malaria may provide insight that can be applied to developing a more effective vaccine.~      People 18 years of age or older who live in Kambila, Tieneguebougou or Kalifabougou, Mali,~     and are in good health may be eligible for this study.~      Participants undergo a complete physical examination at the start of the study and then once~     a year for the 4-year duration of the study. They have a maximum of nine clinic visits a year~     to collect blood samples for research. The visits last about one hour, including a 30-minute~     observation time after the blood draw.~   "
235639|NCT00471289|"~     The purpose of this study is to investigate the performance of paclitaxel-coated balloon~     expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and~     occlusions in patients with critical limb ischemia compared to percutaneous transluminal~     balloon angioplasty (PTA).~   "
235640|NCT00471276|"~     Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease~     progression.~   "
235641|NCT00471263|"~     The primary purpose of the study is to demonstrate a blood pressure lowering effect of~     CasiGold and CasiMax in subjects with high-normal blood pressure or mild hypertension. The~     secondary purpose is to collect human safety data after treatment with CasiGold and CasiMax,~     to gain insight into potential mechanisms by measurement of renin and angiotensin I and II,~     and to evaluate the genetic determinants of the individual BP lowering response by~     measurement of specific genetic polymorphisms.~   "
235657|NCT00471042|"~     The purpose of this treatment research study is to assess the effectiveness of buprenorphine~     maintenance treatment for opioid dependence delivered in a primary care clinic setting. This~     study will determine whether buprenorphine treatment in primary care is effective in reducing~     cravings, reducing illicit opioid use, reducing addiction severity, and retaining patients in~     primary care treatment for opioid dependence.~   "
235642|NCT00471250|"~     This study will collect fluid and tissue specimens from the lungs and nose of healthy people~     and people with a history of lung infections. The specimens will be examined for differences~     between the two groups that may be associated with susceptibility to certain infections.~      Healthy normal volunteers and people with a history of lung infections between 18 and 75~     years of age who are followed at NIH may be eligible for this study.~      Participants undergo the following procedures:~      Medical history and physical examination.~      Blood and urine tests.~      Electrocardiogram (ECG) and chest x-ray.~      Treadmill exercise stress test (for people over 45 years old with a history of chest pain or~     ECG abnormalities).~      Bronchoscopy: The subject s nose and throat are numbed with lidocaine and a sedative is given~     for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth~     into the lung airways to examine the airways carefully.~      Fluid collection during the bronchoscopy using one of the following methods:~        -  Bronchoalveolar lavage: Salt water is injected through the bronchoscope into the lung~          and immediately suctioned out, washing off cells lining the airways.~        -  Bronchial brushings: A brush-tipped wire enclosed in a sheath is passed through the~          bronchoscope and a small area of the airway tissue is gently brushed. The brush is~          withdrawn with some tissue adhering to it.~        -  Endobronchial biopsies: Small pinchers on a wire are passed through the bronchoscope and~          about 1 to 2 millimeters of tissue is removed.~        -  Nasal scrape: A small device is used to scrape along the inside of the nose to collect~          some cells.~   "
235643|NCT00471237|"~     This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in~     the treatment of osteoporosis in post-menopausal women, in comparison with 2 active~     comparators and placebo.~   "
235644|NCT00471224|"~     This protocol intends to detail investigations necessary to evaluate the ocular safety of~     subjects enrolled in study A4321001 and who have received formulated Drug Product (Lot~     8716-098).~   "
235645|NCT00471211|"~     The purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of~     PBT2 administered for 12 weeks compared to placebo in patients with early Alzheimer's disease~     treated with an acetylcholinesterase inhibitor.~   "
235646|NCT00471185|"~     In this study, we propose oral dosing of GIPET enhanced oral acyline (MER-104) to determine~     if this potentially useful compound is safe and effective at suppression of gonadotropins~     after oral dosing in man.~      Hypothesis: A single dose of Acyline will suppress gonadotropins, and testosterone, estradiol~     and dihydrotestosterone (DHT) for 24 hours in man, and the magnitude and duration of the~     suppression will increase with increasing doses of Acyline.~   "
235647|NCT00471172|"~     The aim of the study was to compare 5 methods of delivering a weight loss lifestyle~     modification program to obese patients on a background of sibutramine. The methods differed~     in the type and frequency of counseling utilized to deliver dietary, physical activity and~     behavioral recommendations for weight loss.~   "
235648|NCT00471159|"~     To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel~     for the treatment of patients with advanced breast cancer.~   "
235649|NCT00471146|"~     The purpose of this study is to determine whether investigational study drug, AG-013736, and~     gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.~   "
235650|NCT00471133|"~     The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine~     encoding a melanosomal antigen in melanoma patients at risk for disease progression or~     recurrence. In this study, the vaccine will be administered intramuscularly using a device~     that applies brief electrical fields to the tissue at the site of injection (a technique~     known as electroporation). It is expected that this device will improve the delivery of the~     vaccine. This study is being performed to determine if this procedure can be administered~     safely and if it is capable of inducing immune responses to the vaccine.~   "
235651|NCT00471120|"~     This study aims at developing an accurate, simple, and cost-effective method for screening~     and early detection of uterine cancers~   "
235652|NCT00471107|"~     This study will test the effect of direct current (DC) brain polarization (the application of~     a very weak electrical current to the brain) on learning and memory. Earlier studies have~     shown that DC polarization can temporarily improve the ability of healthy people to think of~     certain words. This study will explore whether it can also temporarily improve learning and~     memory.~      Healthy people 18 years of age and older may be eligible for this study. Subjects participate~     in two experimental sessions at the NIH Clinical Center. The first session lasts about 1~     hour; the second session, on the next day, takes about 10 minutes.~      At the beginning of the first session, electrodes are placed on the subject's head and arm~     for brain stimulation. The current may be turned on for 25 minutes, or only very briefly~     (sham stimulation). Subjects are not told which type of stimulation they are receiving. No~     stimulation is applied in the second session.~      During the sessions subjects are asked to complete the following tasks that will help~     elucidate the effects of polarization:~        -  Read a list of words and remember them. Later they will try to repeat the words from~          memory.~        -  Look at a series of designs and remember them. Later they will try to draw the designs~          from memory.~        -  Push a button on a keyboard when they see a specific item (for example, when the number~          7 appears).~        -  Generate as many words as they can think of that begin with a particular letter of the~          alphabet.~      Subjects may be videotaped for some or all of the time during the sessions.~   "
235653|NCT00471094|"~     The purpose of this study is to assess the efficacy and safety of 8 weeks of daily treatment~     with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing~     subjects with endoscopically proven erosive esophagitis.~   "
235654|NCT00471081|"~     The purpose of the study is to characterize the safety and immunogenicity of 1 dose of~     GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9~     and 12 months of age.~   "
235655|NCT00471068|"~     To compare the efficacy and safety in patients treated with travoprost versus~     dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular~     hypertension~   "
235656|NCT00471055|"~     The purpose of this study is to determine whether capsaicin gel is effective in treating mild~     to moderate degrees of osteoarthritis of the knee in the elderly patient compared with~     placebo gel.~   "
249550|NCT00286065|"~     The purpose of this study is to determine the effect of pain relief with AeroLEF in adult~     patients, following orthopedic surgery.~   "
235661|NCT00470990|"~     Type 2 diabetes is one of the most common metabolic disorders in the U.S, estimated to affect~     16 million Americans. Established risk factors for this disease include obesity, increased~     waist/hip ratio, high insulin levels in the blood, and insulin resistance. Testosterone may~     play a role in developing or preventing diabetes, but we do not yet know for sure. The~     purpose of this research study is to determine if changing testosterone levels in men will~     result in changes in insulin sensitivity. Information learned form this research study may~     have important public health implications and may point to new strategies for treating or~     preventing diabetes.~   "
235662|NCT00470977|"~     The purpose of this study is to evaluate the safety and tolerability of intravitreal~     injections of ranibizumab in the treatment of AMD variants and other choroidal~     neovascularization (CNV) related conditions (Coats' disease, idiopathic perifoveal~     telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma~     elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis) using the incidence~     and severity of adverse events.~      Limited forms of treatment are available that limit the loss of visual acuity. However, the~     patients may not have any substantial improvement in acuity or function. Therefore there~     remains a significant unmet need for therapeutic options managing the neovascularization and~     its consequences.~      Lucentis (ranibizumab) injection will be considered as an attempt to control the growth of~     the abnormal vessels because of evidence suggesting that angiogenic factors, such as vascular~     endothelial growth factor (VEGF), play a role in the pathogenesis of neovascular non-AMD~     conditions.~      The rationale for the study design is as follows:~      A 0.5 mg dose of Lucentis (ranibizumab), a commercially available preparation that is Food~     and Drug Administration (FDA) approved and labeled for intravitreal injection use for~     neovascular (wet) age-related macular degeneration will be used.~      In AMD variants and other CNV related conditions, vascular endothelial growth factor (VEGF)~     plays a role in the pathogenesis as in neovascular AMD.~      Intravitreal injection of ranibizumab delivers maximal concentration of the antibody fragment~     to the vitreous cavity with minimal systemic exposure. The dosing schedule, based on~     considerations of the half-life and the clinical response in patients with neovascularization~     suggests that a 1-month interval is optimal.~   "
235663|NCT00470964|"~     Titanium Sapphire laser trabeculoplasty is effective in lowering intraocular pressure in~     glaucoma patients, and is comparable to argon laser trabeculoplasty~   "
235664|NCT00470951|"~     The investigators designed the randomized prospective trial of comparing open and~     laparoscopic resection in locally advanced rectal cancer after preoperative chemoradiation in~     order to determine the oncologic and functional efficacy of laparoscopic rectal resection.~   "
235665|NCT00470938|"~     Falls are a major concern for the geriatric population and represent a significant public~     health problem. Various interventions are being explored to improve balance and decrease~     falls in the elderly. Success has been shown in some programs; various exercise interventions~     place emphasis on strength, balance, or endurance exercises. Results reported in the~     literature are still equivocal. Controversy exists as to optimal types of exercise, and the~     optimum frequency, duration, and intensity of exercise. It is believed that the SpineForce~     device, which places a unique combination of strength and balance demands upon the user, can~     result in rapid increases in balance as compared to other rehabilitation programs. Gains in~     balance have implications for geriatric populations as well as those seeking enhanced sports~     performance and injury prevention. The Purpose of this study is to assess the SpineForce~     device as a novel intervention in the treatment of balance disorders.~   "
235666|NCT00470925|"~     The overall purpose of this project is to evaluate the effect of sertraline administration on~     the binding of 123-I mZINT in 10 healthy subjects. All study procedures will be conducted at~     the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New~     Haven, CT.~   "
235667|NCT00470912|"~     Lupus erythematosus (LE) is characterized by a large clinical spectrum, and sunligt is a well~     established factor in the induction and exacerbation of this disease. In all subsets of LE,~     skin lesions occur preferentially in sun-exposed areas.~      Previous studies have demonstrated that the lesions in LE patients reproduced in controlled~     experimental conditions. The initial reports suggested that the action spectrum for the LE~     was in the UVB range (290 to 320 nm), but more recent studies have demonstrated that UVA (320~     to 400 nm) can contribute to the induction of LE skin lesions.~      Antimalarial agents and topical steroids are the main treatments of chronic LE. The second~     line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid~     and thalidomide. Moreover, patients are advised to avoid sun, to wear sunprotective clothing~     and to apply sunscreen.~      The aim of this study was to assess the efficacy of a sunscreen milk with high protection~     factor against UV-B and UV-A, used exclusively, in the photoinduced LE.~   "
235668|NCT00470899|"~     Study hypothesis: umbilical cord drainage of fetal blood after delivery of the infant would~     reduce the incidence of feto-maternal transfusion. Patients were randomized to placental~     drainage or no drainage at the time of cesarean section. The incidence of fetal to maternal~     transfusion was noted postoperatively.~   "
235669|NCT00470886|"~     The purpose of this study is to asses the efficacy and safety of Telmisartan depending on the~     use of an electronic therapy monitoring device (HelpingHand) in a real life setting and to~     asses patients compliance to the therapy with Telmisartan in relation to use of electronic~     therapy monitoring device.~   "
235670|NCT00470873|"~     The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing~     surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment~     of erectile dysfunction. The secondary aim of this study is to assess the influence of the~     treatment with Levitra on self-esteem (depressive symptomology) in men with ED.~   "
235671|NCT00470860|"~     This study mapped the time course of forgetting among resident physicians after they use an~     online learning exercise covering principles of diabetes care. Participants took a pre-test~     followed by an online tutorial covering aspects of diabetes care. They then completed a~     post-test on the same topics after a randomly-assigned time delay from 0 to 55 days. We~     hypothesized that post-test scores after these different time delays would decline following~     a curvilinear relationship with increasing time. This understanding of forgetting will inform~     our selection of a time for delivering reinforcement exercises in future educational studies~     among physicians.~   "
235672|NCT00470847|"~     The purpose of this research study is to determine the safety of combining lapatinib plus~     radiation in patients with breast cancer that has spread to the brain. Depending upon the~     participants cancer, they may also have stereotactic radiosurgery (SRS). Lapatinib s a~     compound that may stop cancer cells from growing abnormally. It is thought that lapatinib~     might also make cancer cells more sensitive to radiation. This drug has been used in other~     research studies in women with breast cancer, and information from those other research~     studies suggests that lapatinib may help to shrink or stabilize breast tumors both inside the~     brain and outside the brain.~   "
235673|NCT00470834|"~     Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male~     hormone that leads to benign prostate growth. By blocking the conversion of testosterone to~     DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus~     prolonging bicalutamide's efficacy.~   "
235674|NCT00470821|"~     Sleep disruptions are extremely common in high-risk critically ill patients. The~     investigators want to analyse oral melatonin potentialities as a sedative and a free-radicals~     scavenger for critically ill patients, and secondarily for preventing Delirium during their~     ICU stay and post-traumatic stress disorders after ICU discharge.~   "
235675|NCT00470808|"~     Diabetes is a highly atherogenic disease. Pomegranate juice has impressive antioxidant~     properties. It has been proven to decrease oxidant stress and to cause the regression of~     atherosclerotic plaques in hypercholestrolemic and diabetic patients.Furthermore it has been~     proven to potentiate the biologic activity of the enzyme paraoxonase 1 which is very~     important in preventing atherosclerosis. The study will try to prove that a polyphenolic~     extract from pomegranate (POMx) has the same desired effects.~   "
235676|NCT00470795|"~     Gastroparesis is a common complication of prolonged diabetes mellitus, both with Type 1 and~     Type 2 forms. Treatment of diabetic gastroparesis ranges from changing dietary habits to~     medications and invasive procedures, all of which offer only partial and transient relief,~     with some options having potentially harmful effects. Acupuncture is an ancient treatment~     which has been found to be beneficial for many ailments, including those involving the~     gastrointestinal tract. We propose to evaluate whether acupuncture is an effective and safe~     treatment for diabetic gastroparesis using a randomized, double-blind,~     placebo/sham-controlled crossover trial. Because symptoms of gastroparesis do not correlate~     well with objective tests of gastric emptying (i.e., scintigraphy or 13C breath tests), our~     primary outcome value will be the Gastroparesis Cardinal Symptom Index (GCSI), a reliable and~     validated instrument for quantifying symptoms in these patients. As a secondary outcome we~     will measure gastric emptying using a C13-acetate breath test, as well as the SF-12 Short~     Form Health Survey. Blinding of the participants will be evaluated using a Validation of~     Blinding Questionnaire at the end of the treatment period.~      Diabetic patients suffering from moderate gastroparesis (total GCSI score > 2.50) who fulfill~     the inclusion criteria (and none of the exclusion criteria) will be eligible to participate~     in the study. On induction, participants will fill out the GCSI questionnaire and SF-36~     survey, and will undergo a C13-acetate breath test. They will then be randomly assigned to~     either true acupuncture treatment or placebo/sham acupuncture treatment. Each participant~     will undergo 8 treatments twice-weekly, for a period of 4 weeks. At the end of the eighth~     treatment session, each participant will again fill out a GCSI questionnaire and SF-12 form,~     as well as repeating the C13-acetate breath. Following a 4-week washout period, patients will~     be crossed over to either placebo/sham or true acupuncture treatment, again 8 twice-weekly~     treatments, for a period of 4 weeks. At the end of the second treatment regimen all~     participants will again fill out a GCSI questionnaire and SF-12 form, and undergo a~     C13-acetate breath test. At the end of the second treatment regimen participants will again~     fill out a Validation of Blinding Questionnaire.~   "
235677|NCT00470782|"~     Recent studies have shown that survival after a colorectal cancer diagnosis may be affected~     by a person's activity level and body size. This research says that for colorectal cancer~     patients, the less active and more obese they are, the more likely they are to have a cancer~     recurrence or die from their cancer. Chemotherapy has been shown to reduce activity levels,~     fitness, and body size in some cancer patients. However, it is not known how chemotherapy~     specific for colon cancer patients affects their activity levels, fitness, and body size. The~     main goal of our study will be to look at how chemotherapy treatments affect the fitness,~     activity levels, and body size in colon cancer patients. In order to do this, we will measure~     these variables before chemotherapy treatments, and at 1 and 6 months following the end of~     treatment. Our results will show how chemotherapy affects fitness, activity levels, and body~     size in colon cancer patients and provide data to help in designing an exercise intervention~     specifically for colon cancer survivors.~   "
235678|NCT00470769|"~     It is generally assumed that renal blood flow is symmetric in the absence of renal artery~     stenosis. The importance of studying the function of both kidneys separately is because it~     cannot be assumed that they are functionally equal.The aim of the present study is to~     evaluate whether this is really in patients with essential hypertension and/or moderate~     kidneys loss.~   "
235679|NCT00470756|"~     Every week we encounter with 5-8 pairs of worried parents of infants with forefoot adduction.~     Most of them usually need only reassurance and education how to manipulate the deformed foot.~     During the examination we usually use provocative maneuver to trigger peroneal activity. This~     manual stimulation usually reveals active eversion and dorsiflexion of the foot in most of~     the children, but not in all of them. Small part of the children reacts in opposite direction~     - instead of the typical eversion they demonstrate inversion and some plantar flexion of the~     foot. We have the impression that this subgroup of children improves the deformity slower and~     sometime less complete than most of the children. We did not find in the literature any~     description of this phenomenon. We postulate, that atypically reacting patients probably have~     different response due to abnormalities of neuromuscular balance between invertors-flexors~     and evertors-extensors muscle groups. This small subgroup of children may need more close~     follow-up and probably casting to speed up and secure the improvement of their deformity.~      Study goals:~        1. Evaluate ability of children with FFA to respond on mechanical triggering of peroneal~          activity~             1. The majority of the patients with standard reaction - foot dorsiflexion and~               eversion (evertors)~             2. The minority of the patients with nonstandard reaction - foot plantarflexion and~               inversion (invertors)~        2. Evaluate randomly selected children from each group for character of muscular response~          on electrical stimulation (EMG) of calf muscles.~   "
235680|NCT00470743|"~     The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with~     indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature~     babies born under 29 weeks gestation~   "
235708|NCT00470353|"~     RATIONALE: The use of cholecalciferol and calcium carbonate may keep colon cancer from coming~     back in patients with colon cancer that has been removed by surgery.~      PURPOSE: This randomized clinical trial is studying two different doses of cholecalciferol to~     compare how well they work when given together with calcium carbonate in treating patients~     with colon cancer that has been removed by surgery.~   "
236206|NCT00463762|"~     The primary objective is to collect data on treatment outcomes (clinical and microbiological~     cure), safety and tolerability of treatment with cefoperazone/sulbactam in patients with~     serious intra-abdominal and hepatobiliary infections in Slovakia.~   "
235681|NCT00470717|"~     1. The first aim of this proposal is to pilot the feasibility of weekly phone monitoring of~          infant feeding and illness patterns in a socio-economically and racially diverse~          population. Specifically, the investigators aim to estimate the rate of group loss to~          follow up from birth to 13 weeks (3 months) of age with weekly phone interview of~          mothers of late preterm (LPT, gestational age 34 0/7- 36 6/7 weeks gestation) infants.~        2. The second aim is to describe breastfeeding and formula feeding practices, and rates of~          illness and post-discharge hospital care utilization, through age 13 weeks (3 months)~          among late preterm infants born at MacDonald Women's Hospital. The investigators~          estimate that the rate of exclusive breastfeeding among LPT infants at 3 months of age~          is less than the documented rate of 37% for all infants in Cuyahoga County.~   "
235682|NCT00470704|"~     In this research study we are studying the effects of the combination of lapatinib plus~     Herceptin in subjects with breast cancer that has spread outside of the breast. We are also~     studying whether positron emission tomography (PET/CT) scans can predict which participants~     will benefit from the study treatment. Finally, we are studying genes and proteins in the~     tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination~     of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing.~     Other research studies suggest that lapatinib in combination with Herceptin may help to~     shrink or stabilize breast cancer.~   "
235683|NCT00470691|"~     At our hospital, all Colles' fractures deemed suitable for conservative treatment are reduced~     and immobilised with a plaster of Paris dorsal splint which is converted to a complete cast~     after 10 days. According to individual factors such as age, general health and radiological~     results after 10 days, some patients with severe redisplacement are readmitted to hospital~     for surgery.~      The main purpose of this study is to determine whether, during the first 10 days of~     immobilisation, a complete plaster cast or a dorsal plaster splint best retains the alignment~     of a reduced Colles' fracture. In addition, we aim to compare the complication rates of the~     two methods.~   "
235684|NCT00470678|"~     This study will evaluate efficacy and safety for monthly ranibizumab 0.5 mg intravitreal~     injections in Asian patients with subfoveal choroidal neovascularization secondary to~     age-related macular degeneration.~   "
235685|NCT00470665|"~     The purpose of this study is to assess whether in high-risk kidney transplant patients~     (patients whose previous kidney transplant failed, have a high PRA lab test result or are of~     African-American descent) that a combination of Rapamune with Prograf and steroids will~     prevent acute rejection as well as Rapamune and cyclosporine and steroids.~   "
235686|NCT00470652|"~     Oligoanalgesia1 has been widely recognized as an issue in emergency department.The purpose of~     our study is to assess the impact of the implementation of a computer-assisted support~     program to improve pain management in our ED.~   "
235687|NCT00470639|"~     This is a study to assess the effectiveness of repetitive transcranial magnetic stimulation~     (rTMS) as a treatment for depressed adults with bipolar disorder.~      In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of~     the brain depolarising neurons. No anaesthetic is required and the treatment in~     subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive~     illness in adults (Loo and Mitchell et al, 2005) and appears to be quite safe.~      Most of the published studies to date have focused on unipolar depression. There is limited~     data of TMS use in bipolar depression. Eg. Pilot study by Nahas Z, Kozel FA, Li X, Anderson~     B, George MS.in 2003, which was negative.~      The investigators wish to assess this in a sham-controlled study of adults. The investigators~     hypothesise that both left and right sided rTMS will have an antidepressant effect superior~     to sham in this population.~   "
235688|NCT00470626|"~     The clinical study will collect data to verify the safety and performance of the Cook Celect~     Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent~     high risk of thromboembolism.~   "
235689|NCT00470613|"~     This is a Phase Ib study as a continuation of the original Phase I protocol. The purpose of~     this Phase Ib study is to evaluate the safety of a single course of SGT-53 in combination~     with docetaxel and determine the recommended Phase II doses of SGT-53 and docetaxel in~     combination for evaluation in subsequent clinical studies for the treatment of solid tumors.~   "
235690|NCT00470600|"~     The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative~     hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine~     the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of~     post-operative pain by patients self-assessment of pain.~   "
235691|NCT00470587|"~     The triage of patients with suspected acute coronary syndrome in the emergency room is a~     time-consuming diagnostic challenge. Therefore high sensitive early markers for myocardial~     damage are needed for more rapidly rule out of acute myocardial infarction (AMI) - especially~     for the first 3 to 4 hours after onset of chest pain in AMI (troponin-blind period).~      Therefore we test the hypothesis that the use meticulous patient history and novel cardiac~     markers can provide a faster detection or exclusion of AMI in patients presenting with acute~     chest pain to the emergency department.~      The prospective cohort study is designed to enrol patients presenting with acute chest pain~     at rest within the last 12 hours to the emergency department. Several blood samples for~     detection of the new markers will be drawn and compared with the gold standard for the~     diagnosis of AMI (high-sensitivity cardiac troponin T). All patients will be contacted by~     telephone at 3, 12, 24 and 60 months to determine functional status, major adverse cardiac~     events (death, myocardial infarction, coronary artery bypass grafting, percutaneous coronary~     intervention), and the results of cardiac examination (stress test, coronary angiography) if~     performed.~   "
235692|NCT00470574|"~     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.~     Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more~     tumor cells.~      PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy~     together with QS21 works in treating patients with metastatic breast cancer.~   "
235693|NCT00470561|"~     RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal~     women with a moderate or high level of breast density.~      PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram~     density compared with a placebo in healthy postmenopausal women with a moderate or high level~     of breast density.~   "
235694|NCT00470548|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Pemetrexed may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized~     nanoparticle formulation together with pemetrexed may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel~     albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see~     how well they work in treating patients with advanced non-small cell lung cancer, breast~     cancer, or other solid tumors.~   "
235695|NCT00470535|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with~     stage III or stage IV pancreatic cancer.~   "
235696|NCT00470522|"~     The treatment of systemic lupus erythematosus (SLE) has been aimed at decreasing mortality~     and morbidity because the etiology of the disease is unknown. The general aim of this~     multicentre randomized placebo-controlled trial of low dose intermittent methotrexate with~     folic acid is to establish whether methotrexate shows efficacy and safety in controlling~     disease activity in SLE and preventing flares in disease activity or development of end-organ~     damage. A second aim will be to document the steroid sparing effect of methotrexate in SLE. A~     Third aim will be to measure toxicity and utility of methotrexate with folic acid and to~     perform effectiveness and utility analyses.~   "
235697|NCT00470509|"~     The purpose of this study is to determine whether adalimumab (a TNF-alpha inhibitor) is~     effective in the treatment of severe and acute sciatica.~   "
235698|NCT00470496|"~     This phase I trial studies the side effects and best dose of photodynamic therapy using HPPH~     in treating patients who are undergoing surgery for primary or recurrent head and neck~     cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is~     exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving~     photodynamic therapy after surgery may kill any tumor cells that remain after surgery.~   "
235699|NCT00470483|"~     To compare by neuroimaging techniques the way Social Anxiety patients respond to public~     speaking before and after a drug administration~   "
235700|NCT00470470|"~     This phase II trial is studying how well imatinib mesylate works in treating patients with~     stage III or stage IV melanoma that cannot be removed by surgery. Imatinib mesylate may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
235701|NCT00470457|"~     Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated~     allergies. The disadvantages of SIT, however, are the requirement of numerous allergen~     administrations over three to five years, and that the treatment itself causes frequent~     allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting~     the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety~     and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract~     injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54~     injections over 3 years.~        -  Trial with immunodulatory product / biological~   "
235702|NCT00470444|"~     A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the~     investigators do not know whether transfusions are beneficial and they may be associated with~     harm. It is thus important to determine when a transfusion is required. The investigators~     will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients~     having cardiac surgery will be allocated to one of two transfusion strategies with endpoints~     being compliance with the transfusion strategy and clinical outcome. The results of this~     study will be used to design a large definitive multicentered trial of these two transfusion~     strategies.~   "
235703|NCT00470418|"~     The purpose of this study is to evaluate the safety and efficacy of NIC5-15in the treatment~     of Alzheimer's Disease.~   "
235704|NCT00470405|"~     RATIONALE: Pemetrexed may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving pemetrexed together with oxaliplatin may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed given~     together with oxaliplatin in treating patients with metastatic solid tumors or lymphoma.~   "
235705|NCT00470392|"~     The purpose of this study is 1) to determine whether Imiquimod or Steroid pretreatment~     modifies UVB laser light response resulting in increased cell death compared to UVB laser~     light alone; 2) to determine if pretreatment of psoriatic lesions with Imiquimod or Steroid~     prior to UVB laser light exposure selectively effects various T cell functions; 3) to~     determine clinical results from the Imiquimod/Steroid/UVB laser light and correlate those~     changes with immuno-histochemical changes in the skin; and 4) to determine if single high~     dose lesion limited UVB laser light intervention combined with Imiquimod or Steroid~     influences T cell changes~   "
235706|NCT00470379|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Giving vaccine therapy together with resiquimod may make a stronger~     immune response and prevent or delay the recurrence of cancer.~      PURPOSE: This clinical trial is studying the side effects, best dose, and best way to give~     vaccine therapy together with resiquimod in treating patients with stage II, stage III, or~     stage IV melanoma that has been completely removed by surgery.~   "
235707|NCT00470366|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune~     cells found in bone marrow or peripheral blood and may help the immune system recover from~     the side effects of chemotherapy.~      PURPOSE: This phase II trial is studying the side effects and how well giving combination~     chemotherapy together with pegfilgrastim works in treating patients with previously untreated~     germ cell tumors.~   "
235878|NCT00468117|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells~     are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess~     the benefit of islet transplantation in type 1 diabetic (T1D) kidney transplant recipients.~   "
235709|NCT00470340|"~     Besides liver transplantation, the curative treatment of primary hepatic cancer with~     cirrhosis remains the surgical resection. Radiofrequency or cryotherapy currently allow local~     ablation of small cancer, with very good results. However, all these treatments are followed~     by high rates of recurrence (50 - 70% at 5 years). Then, it seems essential to associate to~     the surgical resection or to the local ablation as adjuvant treatment, in order to prevent~     or to decrease the rate of recurrence. However, no evidence supports this attitude.~     Therefore, following curative treatment of primary hepatic cancer with cirrhosis, we propose~     to compare treated to untreated patients. Postoperative treatment means either intra-arterial~     chemotherapy or systemic chemotherapy. The main criterion of the study is time of survival~     without recurrence. The main secondary objective is the safety.~   "
235710|NCT00470327|"~     We propose to acquire data and blood samples on all patients being cared for by the~     Interstitial Lung Disease (ILD) program. Additionally, we will collect data and blood samples~     from a control group for comparator purposes. In doing so, we will be able to describe the~     phenotypic expression of these diseases.~   "
235711|NCT00470314|"~     The purpose of the study is to determine whether L-Ornithine L-Aspartate infusion improves~     the survival of patients with acute liver failure.~   "
235712|NCT00470301|"~     Tipifarnib may stop the growth of breast cancer by blocking some of the enzymes needed for~     cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as~     paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib~     together with combination chemotherapy may kill more tumor cells. This phase I/II trial is~     studying the side effects and best dose of tipifarnib when given together with combination~     chemotherapy and to see how well they work in treating patients with stage II or stage III~     breast cancer.~   "
235713|NCT00470288|"~     Objective: To compare outcomes in cesarean section patients undergoing bladder flap versus~     none. Hypotheses: Operative time will be reduced with the elimination of a bladder flap~     during cesarean delivery and intra-operative and post-operative morbidity will not be~     significantly different.~      Patients >= 35 wks gestation undergoing cesarean delivery will be randomized to bladder flap~     vs. none. Primary outcome is operative time (start to delivery); secondary outcomes include:~     injuries, EBL, intra-operative and post-operative complications,pain medication, hospital~     stay duration.~   "
235714|NCT00470275|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well cytarabine works in treating young patients~     with recurrent or refractory Ewing's sarcoma.~   "
235715|NCT00470262|"~     The relationship between obesity and insulin resistance is known, however the mechanism(s)~     associating obesity with insulin resistance is not well understood. Inflammation and~     accumulation of fat in non fat tissue (like muscle) are conditions found on obesity which~     could be the potential link between obesity and insulin resistance. This study is designed to~     test the effects of two different drugs on numerous features of the obesity and insulin~     resistance in subjects with impaired glucose tolerance. Impaired glucose tolerance is a~     condition where blood sugar is too high after drinking a sugary drink containing 75 grams of~     sugar. Impaired glucose tolerant subjects are insulin resistant and at risk of developing~     diabetes. The drugs to be used are fenofibrate and pioglitazone. Fenofibrate is used to~     reduce the amount of fat (triglycerides) in the blood while pioglitazone is routinely used to~     make the body more sensitive to insulin in patients with diabetes. The purpose of this study~     is to compare the effects of either of these two medications (pioglitazone and fenofibrate)~     alone or the combination of both on fat accumulation in body (muscle) and inflammation. The~     amount of fat accumulation in muscle is thought to affect insulin sensitivity. In addition,~     the changes in the level of proteins produced by fat tissues will be studied in response to~     the two medications in this study. These proteins are thought to be involved in diabetes and~     insulin resistance.~      These studies are designed to examine fundamental clinical mechanisms underlying the~     metabolic syndrome and diabetes.~   "
235716|NCT00470249|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving carboplatin together with~     gemcitabine works in treating patients with locally advanced or metastatic breast cancer.~   "
235717|NCT00470236|"~     Hypotheses:~        1. The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the~          risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast).~        2. The risk of local recurrence in the shorter fractionation arm is not worse than that for~          the standard fractionation arm.~        3. A molecular signature predictive of invasive recurrence of DCIS will be detectable and~          the molecular signature may eventually have clinical utility for therapy~          individualization.~      Overall Objectives:~        1. To improve the outcome of women with non-low risk DCIS treated with breast conserving~          therapy.~        2. To individualize treatment selection for women with DCIS to achieve long term disease~          control with minimal toxicity.~   "
235718|NCT00470223|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the~     growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. Giving these treatments after surgery may kill any tumor cells that remain after~     surgery. It is not yet known whether giving combination chemotherapy together with zoledronic~     acid is more effective than combination chemotherapy alone in treating osteosarcoma.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic~     acid to see how well they work compared with combination chemotherapy alone in treating~     patients with osteosarcoma.~   "
235879|NCT00468104|"~     The purpose of this study is to document the efficacy and safety of intrapleural instillation~     of Activase vs Placebo in the management of complicated pleural effusions and empyemas~   "
235719|NCT00470210|"~     This trial will assess the sustained virologic response to treatment with peginterferon~     alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected~     patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase~     elevations. These patients will have been nonresponders to previous regimens with~     peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.~   "
235720|NCT00470197|"~     Drugs used in chemotherapy, such as flavopiridol, cytarabine, and mitoxantrone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving a new schedule of more than one drug (combination chemotherapy)~     may kill more cancer cells. This phase I trial is studying the side effects, best dose, and~     best schedule for flavopiridol when given together with cytarabine and mitoxantrone in~     treating patients with relapsed or refractory acute leukemia.~   "
235721|NCT00470184|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     chemotherapy together with radiation therapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine~     together with radiation therapy works in treating patients undergoing surgery for stage II,~     stage III, or stage IV esophageal cancer.~   "
235722|NCT00470171|"~     This is a phase II study with direct individual benefit. It is a randomized, double blind~     placebo controlled study whose aim is to evaluate the efficacy and tolerance of~     ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis.~      The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment~     associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in~     transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is~     defined as a significantly larger decrease in average ALAT levels between the time of~     inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as~     compared to the placebo group.~      The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take~     place at the end of the 12th month of treatment.~   "
235723|NCT00470158|"~     With the long-term public health goal of developing an effective micronutrient~     supplementation program to improve child health by improving iron and zinc status and~     decreasing morbidity due to diarrhea in areas with high rates of childhood malnutrition, we~     seek to determine the most efficacious method of decreasing childhood morbidity and mortality~     due to diarrhea in toddlers by re-examining the issue of iron and zinc interaction and~     determining if this interaction can be minimized by separate administration of iron and zinc~     supplementation.~   "
235724|NCT00470145|"~     SB-568859 is a medication that is being developed for the treatment of atherosclerosis~     (hardening of the arteries). The purpose of this study is to see if there is a difference in~     how the human body takes up the study drug depending on how the study drug is made. This~     study will compare SB-568859 tablets that are made in 2 different ways. This is not a~     treatment study.~   "
235725|NCT00470132|"~     The retrospective study will help determine whether or not placement of new devices prior to~     the recommended time was associated with a high risk of relapse or treatment failure.~   "
235726|NCT00470119|"~     RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese~     postmenopausal woman's risk of developing breast cancer. It is not yet known whether a~     low-calorie diet and/or exercise program are more effective than no diet or exercise program~     in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.~      PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or~     exercise program on risk factors for developing breast cancer compared with no diet or~     exercise program in overweight or obese postmenopausal women.~   "
235727|NCT00470106|"~     Veterans with schizophrenia and schizoaffective disorder experience very high levels of~     disability and poor community outcome. Further improvements in community outcome for patients~     with these disorders will not occur simply through better control of clinical symptoms.~     Instead, it will be necessary to find treatments that address the key determinants of poor~     functional outcome. Evidence strongly suggests that basic (non-social) cognitive and social~     cognitive deficits are among the key determinants of functional outcome for these illnesses.~     The primary goal of this 2-year pilot study is to implement and validate a new remediation~     program for social cognition that is appropriate for veterans with schizophrenia and~     schizoaffective disorder.~   "
235728|NCT00470093|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may~     stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with~     interleukin-6 may kill more cancer cells.~      PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa~     together with interleukin-6 works in treating patients with recurrent multiple myeloma.~   "
235729|NCT00470080|"~     This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral~     sucrose solution compared to oral sucrose solution alone before venepuncture in preterm~     infants.~   "
235730|NCT00470067|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome~     together with carboplatin works in treating patients with recurrent, stage III, or stage IV~     primary endometrial cancer.~   "
235731|NCT00470054|"~     This phase II trial is studying how well dasatinib works in treating patients with relapse~     small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
235732|NCT00470041|"~     Description: To investigate bioavailability of two anti-viral drugs (lamivudine and~     zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric~     use.~      Interventions: 12 healthy volunteers will receive in a cross-over design two formulations~     i.e. the commercially available tablet formulation and the trial formulation. Blood samples~     (13 over 24 h) will be taken in order to determine the pharmacokinetic profile of the drugs~     from both formulations and will be compared.~      Duration of intervention: 2 days + 7 days of wash-out between both oral administrations.~   "
235733|NCT00470028|"~     This is a study to assess the effectiveness and safety of repetitive transcranial magnetic~     stimulation (rTMS) as a treatment for depressed 13-18 year olds.~      In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of~     the brain depolarizing neurons. No anesthetic is required and the treatment in subconvulsive.~     Recent studies suggest that rTMS can be an effective treatment for depressive illness in~     adults (Loo and Mitchell, 2005) and appears to be quite safe.~      Minimal data of TMS use in adolescents psychiatric disorders. Data only existed in seven~     patients of the four that were depressed two showed improvement in their depression~     (Quintana, 2005). No sham-controlled studies have been conducted.~      The investigators wish to assess this in a sham-controlled study of 30 adolescents. The~     investigators hypothesize that rTMS will have an antidepressant effect and produce no~     neuropsychological impairment.~   "
235734|NCT00470015|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of~     immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white~     blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in~     incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy~     together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with~     stage II, stage III, or stage IV melanoma.~   "
235735|NCT00470002|"~     The purpose of the study is to determine whether the treatment with growth hormone has an~     influence on the nitric oxide pathway in healthy males.~   "
235736|NCT00469989|"~     There has been considerable debate over the last 30 years about the interaction between~     asthma and parasitic infection. It has been suggested that at least part of the reason for~     the increasing prevalence of asthma in the developed world is a decrease in parasite~     infections resulting from improved living conditions with economic development. Our previous~     studies in Ethiopia suggest that hookworm infection may be particularly important in this~     process.~      To establish definitively whether parasites can protect against allergic disease, and~     specifically asthma, ultimately requires a randomised clinical trial of parasite infection in~     patients with asthma. We, the researchers at the University of Nottingham, have completed a~     study in normal volunteers to establish the dose of hookworms necessary to generate infection~     at the level shown to be protective in population surveys, and shown that infection is well~     tolerated. In addition, we have recently completed a randomized placebo-controlled clinical~     trial of hookworm infection in allergic patients with rhinitis which showed that there was no~     negative effect on bronchial responsiveness during the phase in the lifecycle where the~     hookworm larvae migrate through the lungs. Consequently, are now proceeding with the~     definitive randomized placebo-controlled trial of hookworm infection in people with asthma.~     This study will also provide us with the opportunity to investigate the cellular mechanisms~     of the effect of hookworm infection on the immune system.~   "
235737|NCT00469976|"~     RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as bevacizumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Giving enzastaurin together with carboplatin and~     gemcitabine, with or without bevacizumab, may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving enzastaurin together with~     carboplatin and gemcitabine, with or without bevacizumab, works in treating patients with~     recurrent, stage IIIB, or stage IV non-small cell lung cancer.~   "
235738|NCT00469963|"~     RATIONALE: Specialized internal radiation therapy that delivers a high dose of radiation~     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This clinical trial is studying how well internal radiation therapy works in~     treating patients with primary liver cancer that cannot be removed by surgery.~   "
235739|NCT00469950|"~     The Efector study is an open, randomized and controlled trial assessing the effect of regular~     exercise training on endothelial function, inflammatory markers, progression of disease,~     heart rate variability and mental health in patients who have been successfully treated with~     percutaneous coronary intervention and stent implantation for angina pectoris.~   "
235740|NCT00469937|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as~     lithium, may protect normal cells from the side effects of radiation therapy. Giving lithium~     together with radiation therapy may allow a higher dose of radiation therapy to be given so~     that more tumor cells are killed.~      PURPOSE: This phase I trial is studying the side effects and best dose of lithium when given~     together with whole-brain radiation therapy in treating patients with brain metastases from~     primary cancer outside the brain.~   "
235741|NCT00469924|"~     Patients in hospitals may develop serious problems that are detected by blood tests. It is~     very important for the physicians to be notified of these abnormal blood tests as soon as~     possible. Currently, this is done using phone calls from the lab to the nurse. The nurse then~     pages the doctor and waits for a call back. We are conducting a study using an automated~     paging system that immediately alerts the physician directly. We will test whether the~     automated system affects the time for the physician to respond to the abnormality. If the~     physician's patient has a serious laboratory result, we will automatically send this~     laboratory result to the physician's PDA. We will also provide guidelines for treating the~     patient. These guidelines will come from existing hospital policies where available, or from~     local expert opinion. We will determine whether patients get better and faster care because~     of the automated alerting system.~   "
235757|NCT00469716|"~     Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema~     formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch~     (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal~     model. We hypothesize that a continuous infusion of HSH will reduce fluid load and increase~     hemodynamic and respiratory functions in patients undergoing coronary artery bypass with CPB.~   "
235758|NCT00469703|"~     The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating~     patients with chronic pancreatitis.~   "
235742|NCT00469911|"~     Cardiovascular disease is the leading cause of death in patients with diabetes mellitus (DM),~     with atherosclerosis accounting for approximately 80% of the cases. Although the cause for~     the increased cardiovascular risk is multi-factorial, there is compelling evidence obtained~     from experimental models of DM suggesting that excessive myocardial lipid uptake may be~     contributory. This ectopic deposition of lipid, often stored as triacylglycerol (TAG) may~     directly cause myocardial damage and decreased function through a variety of mechanisms.~     However, accurate translation of these findings to humans with DM, requires an noninvasive~     imaging method that provides both accurate and reproducible measurements of myocardial tissue~     TAG. Currently, no such imaging method exists.~   "
235743|NCT00469898|"~     RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have~     been very encouraging. As the toxicity profile associated with carboplatin is preferable over~     cisplatin it is our expectation that patients and physicians would prefer to use this~     combination if it is equally or more efficacious. To date there has been no agreement~     regarding the optimal combination of these agents. Based on the trials described in the~     protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell~     lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on~     days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin~     works as first-line therapy in treating patients with extensive-stage small cell lung cancer.~   "
235744|NCT00469885|"~     This study evaluates the effect of smoking reduction vs usual care (quitting advice only) for~     individuals with peripheral arterial disease who smoke.~   "
235745|NCT00469872|"~     This study will compare two treatment approaches that are currently being used for children~     with cerebral palsy. Both treatments aim to improve a child's function. The two approaches~     being compared are: 1) improving function by working with the child to improve his/her skills~     and abilities (child-focused approach) and 2) improving function by changing/adapting the~     task and/or environment around the child to improve his/her skills and abilities~     (context-focused approach). It is hypothesized that the context-focused approach will~     significantly improve activity and participation outcomes while leading to no significant~     decreases in body function and structure outcomes.~   "
235746|NCT00469859|"~     RATIONALE: Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving lestaurtinib together with cytarabine and idarubicin may~     kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of lestaurtinib~     when given together with cytarabine and idarubicin and to see how well they work in treating~     younger patients with relapsed or refractory acute myeloid leukemia.~   "
235747|NCT00469846|"~     This study is intended to assess the efficacy of L-arginine supplementation with antioxidant~     vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk~     population.~   "
235748|NCT00469833|"~     The objective of this project is to understand defects in insulin secretion that contribute~     to abnormal glucose metabolism in patients with diabetes. In particular the effects of~     signals released from the intestine to stimulate insulin secretion will be tested. Patients~     with type 2 diabetes will have insulin secretion in response to glucose and intestinal~     factors before and after insulin treatment to lower their blood glucose. It is expected that~     the results of this work will provide valuable information for treating diabetic people.~   "
235749|NCT00469820|"~     RATIONALE: Vaccines made from the patient's cancer cells may help the body build an effective~     immune response to kill cancer cells. Giving vaccine therapy together with donor lymphocyte~     infusion after a stem cell transplant from the patient's brother or sister may kill any~     cancer cells that remain after transplant.~      PURPOSE: This clinical trial is studying the side effects, best dose, and how well vaccine~     therapy with or without donor lymphocyte infusion works in treating patients with acute~     myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma undergoing donor stem~     cell transplant.~   "
235750|NCT00469807|"~     In this study, we have assessed the potential prognostic value for gestational outcome of~     maternal ghrelin levels at very early stages of IVF pregnancies. In addition, ghrelin~     responses to meal intake were explored at early gestation.~   "
235751|NCT00469794|"~     Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The~     aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by~     an exercise test in a retrospectively evaluated athletic population.~   "
235752|NCT00469781|"~     The objective of this study is to determine if twice-daily dosing of prednisolone (Pred~     Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of~     retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly~     with twice-daily bromfenac.~   "
235753|NCT00469768|"~     IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in~     Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from~     matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess~     safety and tolerability compared to placebo~   "
235754|NCT00469755|"~     To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1%~     compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment~     with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream~   "
235755|NCT00469742|"~     This is a retrospective chart review study. The purpose of this study is to review our~     experience at Children's Healthcare of Atlanta in neonates receiving aprotinin. We will~     examine the specific outcomes of renal dysfunction, thrombosis and mortality.~   "
235756|NCT00469729|"~     The purpose of this study is to determine the efficacy and safety of transplanting StemEx® in~     patients with certain hematological malignancies. For these patients, it is suggested that~     StemEx® can improve upon the outcome of transplanting a single, unmanipulated cord blood unit~     by significantly increasing the number of stem/progenitor cells available to the patient.~   "
235759|NCT00469690|"~     The purpose of this study is to compare the ability of two different topical NSAIDs~     (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the~     eye and to stop inflammation. The study will conclude on the day of your cataract surgery.~   "
235761|NCT00469651|"~     This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24~     months in Tanzania in a highland area with low malaria transmission.~      Written informed consent will be sought from all guardians/parents of potentially~     participating children. Eligible children will be randomly allocated to receive either the~     the study vaccine (MSP3 for a total of 30 children)) or the control vaccine (hepatitis B for~     a total of 15 children). The vaccines will be given in 3 immunizations one month apart to all~     the study children and neither the clinical investigators nor the children's parents will be~     aware of which vaccine has been administered during the initial four months of the study. The~     study is designed to begin with a lower dose of the MSP3 vaccine (15µg of MSP3 for 15~     children) and then followed by the higher dose(30µg MSP3 for 15 children). Following each~     immunization, children will be evaluated for a seven day solicited symptoms. Unsolicited~     symptoms will also be collected throughout the study duration.~      The study will be overseen by an international safety monitoring committee who will follow~     safety matters closely as the trial progresses. The study will also be approved by the~     Tanzania National ethics Committee, The Tanzania Food and Drugs Authority, and the London~     school of hygiene and tropical medicine ethics committee. The study is planned to last 13~     months for each participant.~   "
235762|NCT00469638|"~     To prove if the success rate of curative treatment of atrial fibrillation in left atrial~     circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer~     giving access to the left atrium then by using a conventionally introducer with fixed curve.~   "
235763|NCT00469625|"~     Diabetic Nephropathy and other proteinuric renal diseases are the major cause of kidney~     disease in the United States. The degree of proteinuria is associated with risk for renal~     disease progression and cardiovascular outcomes. Deficiency of 1-25 Vitamin D develops early~     in CKD, and is undertreated. Vitamin D may have important effects on factors that drive~     proteinuria and renal disease progression in patients with proteinuric renal diseases.~     Therefore, Paricalcitol treatment may reduce proteinuria and slow renal deterioration.~   "
235764|NCT00469612|"~     The purpose of the present study is to carry out a trial to evaluate the clinical efficacy of~     the NeuroVision Low Myopia Treatment.~      The specific questions to be answered are:~        1. Is there an improvement in vision following the treatment without bringing about a~          change in the subject's prescription for glasses?~        2. Can any treatment effect be seen at 6 months and 12 months after the termination of the~          treatment?~   "
235765|NCT00469599|"~     The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of~     secondary hyperparathyroidism in hemodialysis patients.~   "
235766|NCT00469586|"~     This trial is conducted in Europe, Asia, North America and South America. The aim of this~     research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin~     combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of~     use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).~   "
235767|NCT00469573|"~     The purpose of this study is to determine if Optive®eye drops are safe for people who wear~     contact lenses and have dry eyes. The second goal of the study is to determine if using~     Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).~   "
235768|NCT00469560|"~     Open label, single arm study on Deferasirox treatment in MDS patients with chronic~     transfusional hemosiderosis.~      Patients receive daily oral dosis of Deferasirox in order to eliminate the quantity of iron~     administered during transfusions and, if needed, to reduce the overload of already present~     iron.~      After an screening phase in which patients are evaluated according to eligibility criteria, a~     one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.~   "
235769|NCT00469547|"~     The purpose of this study is to look at the safety and acceptance of using a microbicide~     (product that kills germs) gel to clean the genital area. Microbicide gel is used by hospital~     workers to clean their hands to kill germs. Researchers hope to use information from this~     study to conduct a larger study to determine if the microbicidal gel protects men against~     sexually transmitted infections, including HIV. Thirty healthy uncircumcised Kenyan men, 18~     years and older, working in the fishing industry in Kisumu will be recruited. Participants~     will complete a questionnaire about their background and sexual practices. A researcher will~     conduct a detailed examination of the genital area with a magnifying glass. A blood and urine~     sample will be collected to test for infection. Each participant will use both the~     microbicidal gel and a placebo (contains no active ingredient) gel at different times during~     the study, and the results will be compared. Volunteers will participate up to 8 weeks.~   "
235770|NCT00469534|"~     A Pilot Study Evaluating Minimized Time to Beam Hypofractionated IMRT with PET Assisted~     Target Definition in Patients with High Grade Gliomas~      The aim of this pilot project is to explore the feasibility of combining a simple conformal~     plan (Phase I) with an IMRT treatment approach (Phase II) for high grade glioma patients with~     the aim of starting the RT as soon as possible following the patient's first outpatient visit~     (thus, minimized 'time to beam'). It is hoped that the rapid treatment start with the initial~     3D CRT plan will lessen clinical deterioration due to the growth of these aggressive tumours.~     The use of Linac-based IMRT in Phase II of the patient's treatment plan will maintain the~     benefit of the sophistication of IMRT.~      Using novel PET imaging we also hope to better characterize regions of glioma cells thus~     producing more optimized planning target volumes (PTVs) for each patient and decreasing the~     volume of normal brain irradiated with the aim of minimizing radiation toxicities. Hopefully~     this planning and treatment approach will provide an improvement in the quality of life and~     outcome for high grade glioma patients.~   "
235771|NCT00469521|"~     To determine baseline tear thickness and improvement immediately post installation of two~     artificial tear solutions:(9582X) and Allergan Refresh Tears.~   "
235788|NCT00469300|"~     Currently approved drugs for the treatment of herpes labialis (cold sores) exhibit low levels~     of efficacy due to the limited ability of the drugs to penetrate the skin to the sites where~     the herpes virus is replicating. Iontophoresis uses electric current to enhance delivery of~     drugs through the skin. This trial is testing a new iontophoretic device with a new acyclovir~     gel to treat cold sores.~   "
236257|NCT00463099|"~     The purpose of this study is to determine the effect of modifiable risk factors on knee~     function, osteoarthritis, and re-rupture of the anterior cruciate ligament (ACL) following~     ACL reconstruction.~   "
235772|NCT00469508|"~     Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and~     is approved for managing symptoms of narcolepsy (i.e., daytime somnolence). Its precise~     mechanism of action in promoting wakefulness remains unclear. This trial is a~     placebo-controlled double-blind trial of modafinil, on a platform of contingency management~     (CM) and individual cognitive-behavioral (CBT) counseling, for the treatment of~     methamphetamine dependence. Participants in this study will complete a 2-week baseline~     screening period during which they will provide urine samples and complete physical and~     psychological assessments to establish their eligibility for the study. In addition,~     participants will be asked to provide a blood or saliva specimen for genetic testing in order~     to identify genetic variations that influence response to methamphetamine and to treatment~     with modafinil. Upon successful completion of screening, participants will be randomly~     assigned to receive either modafinil (400mg qd) or placebo during the 12 weeks of the study.~     Neither the participants nor study staff will know who is receiving active medication or~     placebo. Regardless of medication condition, all participants will receive CM and weekly~     individual CBT counseling sessions to help them stop using methamphetamine and prevent~     relapse. They will attend the clinical research site (either at the UCLA Hollywood Clinic, or~     the Rancho Cucamonga site) three times per week, providing urine samples at each visit,~     completing data measures, and receiving individual CBT counseling on one visit each week. At~     the end of the 12-week study, the medication or placebo will be discontinued. Participants~     will return to the research site approximately 30 days following medication discontinuation~     for a brief health check to assess any possible lingering side effects and complete brief~     data measures.~   "
235773|NCT00469495|"~     The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic~     therapy combined with standard pentavalent antimony in the treatment of subjects co-infected~     with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is~     that early intervention with antihelminthic therapy will improve response rates to antimony~     in subjects with cutaneous leishmaniasis.~   "
235774|NCT00469482|"~     A combined strategy of Richmond Agitation and Sedation Scale (RASS) clinical targeting plus~     bispectral index (BIS) guided sedation in mechanically ventilated, critically ill patients~     will decrease time on mechanical ventilation, decrease the duration of intensive care unit~     (ICU) delirium and coma, and will improve subacute neurocognitive function when compared to~     sedation guided by RASS targeting alone.~   "
235775|NCT00469469|"~     This is a Phase II study of intravenous Bevacizumab in patients with pathologically confirmed~     nonresectable primary adrenocortical cancer (ACC). Patients must have received no prior~     therapy. They will receive Bevacizumab as a single agent every 2 weeks intravenously until~     disease progression. This study will be open at multiple sites.~   "
235776|NCT00469456|"~     The objective of this study is to evaluate the effect of memantine versus placebo on~     functional communication in patients with Alzheimer's Disease~   "
235777|NCT00469443|"~     This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with~     the addition of Avastin as 1st line treatment of colorectal cancer.~   "
235778|NCT00469430|"~     The purpose of this study is to determine if antibiotic treatment of appendicitis is an~     option compared to surgery. The investigators' hypothesis is that a majority of patients with~     appendicitis can heal without surgery and that there are several advantages with antibiotic~     treatment related to time to recover, complications and economical aspects.~   "
235779|NCT00469417|"~     The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with~     methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of patients with primary~     superficial basal cell carcinoma.~      Secondary objectives are to compare cosmetic outcome and tolerability (adverse events) in~     these patients, 3 months after treatment. In addition the recurrence rates in the two~     treatment groups will be compared up to five years after treatment.~   "
235780|NCT00469404|"~     The purpose of this study is to determine whether the plasma levels of two different~     analgesic transdermal patch formulations lead to same plasma levels of the active ingredient~     after single dose application.~   "
235781|NCT00469391|"~     The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients~     who require weight loss prior to their Bariatric surgery.~   "
235782|NCT00469378|"~     This is a study to count the number of white blood cells in the cerebrospinal fluid and blood~     at the beginning and end of treatment with firategrast and at 4 and 12 weeks after stopping~     firategrast. Cerebrospinal fluid flows through and protects the brain and spinal cord. It is~     important to understand what happens to the number of white blood cells because they are~     important in preventing infections.~   "
235783|NCT00469365|"~     Compare the effectiveness of 3 strategies by pharmacists to decrease the time to refill of~     prescriptions for common chronic diseases (diabetes, hypertension, hyperlipidemia, heart~     failure, depression, psychoses).~   "
235784|NCT00469352|"~     The purpose of this study is to understand whether genes or certain factors in the~     environment determine how eyes will respond to Lucentis (ranibizumab) treatment. For example,~     whether having variants within specific genes means that a patient is likely to get better~     vision from treatment than another patient with different genes.~   "
235785|NCT00469339|"~     This study will examine what methods work best for encouraging Mexican-American family~     members to talk about their risk for diabetes, heart disease, breast cancer and colon cancer.~     Within the Mexican-American community, the family culture provides an important setting in~     which individuals interpret and share their health information and formulate strategies to~     engage in health-promoting behaviors. The information from the study will be used to design~     risk communication approaches for Mexican-American households.~      Members of households with at least three adults 18 to 70 years of age who are part of the~     existing Mexican-American households recruited by the University of Texas M.D. Anderson~     Cancer Center may be eligible for this study.~      Participants are interviewed about their medical history, family history of disease, health~     behaviors, beliefs about disease and disease risk, experiences living in the United States,~     and relationships with family members and close friends. They are then provided information~     about their family risk for diabetes, heart disease, breast cancer and colon cancer, based on~     the information they provided in the interview. Two additional interviews are conducted over~     the telephone that include questions about how the participants communicate with family~     members about their risk and health behaviors.~   "
235786|NCT00469326|"~     This study investigates potential protective effect of atorvastatin pre-treatment in patient~     with stable coronary artery disease undergoing percutaneous coronary intervention (PCI).~     Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two~     days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is~     myocardial infarction measured by troponin I and creatine kinase myocardial band.~   "
236258|NCT00463086|"~     The purpose of this study is to evaluate whether isoniazid can safely (and further) reduce~     the risk of tuberculosis in HIV infected people receiving HAART.~   "
235789|NCT00469287|"~     Rationale: The global prevalence of diabetes, along with its devastating effects on life~     expectancy and quality of life, continues to increase. Worldwide, the total number of people~     with diabetes is projected to rise from about 171 million in 2000 to 336 million in the year~     2030. Type 2 diabetes accounts for about 85 percent to 95 percent of all diagnosed cases of~     diabetes and is associated with a number of serious long-term complications, which are a~     major cause of morbidity, hospitalization and mortality in diabetic patients. More evidence~     is becoming available that both lifestyle and clinical intervention in the pre-diabetic~     condition are effective in slowing down progression of pre-diabetes to overt diabetes.~      Over many centuries, several forms of traditional medicine have developed which are often~     based on fundamental principles that differ from those of Western medicine. One of the most~     prominent characteristics of Traditional Chinese Medicine (TCM), is a more holistic approach~     to the functioning and disfunctioning of living organisms. Every healthy organism is in a Yin~     Yang balance and is considered to be a complex interplay between body and mind. Western~     medicine relies on detailed classification of diseases, empirical investigations and~     treatments targeting those disorders. However, Western medicine is showing an increased~     interest in traditional forms of medicine.~      Objectives: The primary objective of the present study is to determine consistency in~     classification of DM type 2 in three categories as defined by Traditional Chinese Medicine~     (TCM) in pre-diabetic subjects.~      Secondary objectives are to find relationships between diagnosis according to TCM and risk~     profile according to Western approach (fasting glucose and HbA1c in plasma, age, BMI, waist~     circumference). Another objective is to find relationships between classification of risk for~     DM type 2 according to TCM and objective parameters.~   "
235790|NCT00469274|"~     The purpose of this study is to compare the effectiveness of two strategies of post-exposure~     prophylaxis (PEP) in healthcare workers (HCWs) who have been vaccinated with acellular~     pertussis vaccine and have been exposed to pertussis Secondary Objectives include a~     comparison of the costs of each PEP strategy and an assessment for risk factors associated~     with healthcare-associated acquisition of pertussis.~   "
235791|NCT00469261|"~     The aim of the study is to assess the efficacy of an antibiotic treatment with tetracycline~     (doxycycline) in the early stage of large reperfused acute myocardial infarction (AMI), in~     preventing left ventricular (LV) remodeling.~   "
235792|NCT00469248|"~     The role of intra aortic balloon counterpulsation in patients experiencing acute myocardial~     infarction with shock is not established. We hypothesised that use of such a device would~     lead to improved outcomes in these patients.~   "
235793|NCT00469235|"~     This trial will assess the safety and efficacy of 50 and 200ng Juvista per linear cm of wound~     margin administered by intradermal injection following the excision of keloid scars on the~     ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly~     distressing for patients as they are very difficult to conceal and are usually bilateral. As~     the recurrence rate and growth rate of keloids can vary significantly between individuals,~     trial subjects will have bilateral ear lobe keloids and will act as their own control. One~     ear lobe will be treated with Juvista following keloid excision and one with placebo.~   "
235794|NCT00469222|"~     Current treatments for limited stage small cell lung cancer have poor cure rates. The~     addition of chest radiation to chemotherapy improves cure rates, but these cancers still come~     back in the chest 30-50% of the time. Two factors which can improve control and cure rates~     for this cancer are increasing the chest radiation dose and minimizing the overall time it~     takes to complete radiation treatments. One method to achieve both of these goals is to give~     more radiation each day. This study is meant to study how tolerable and effective it would be~     to increase the intensity of chest radiation for small cell lung cancer patients by~     increasing the daily radiation dose. We aim to find the highest dose of chest radiotherapy~     that can be safely given with chemotherapy using this strategy. Patients in this trial will~     be monitored before, during and after their radiation and chemotherapy treatments for~     treatment side-effects, how effective treatments are at controlling their cancer and quality~     of life changes. Results from this trial will help to define more effective radiotherapy~     doses which are tolerable for this type of lung cancer and the quality of life changes~     patients experience when they undergo these treatments.~   "
235795|NCT00469209|"~     Primary Objectives:~        1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic~          trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma~        2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic~          acid and high-dose melphalan in patients with multiple myeloma~        3. To determine the effects of bortezomib on melphalan pharmacokinetics~   "
235796|NCT00469196|"~     Mesothelioma is an incurable cancer involving the lining of the lung. Patients usually suffer~     progressive symptoms of shortness of breath and chest pain, until they ultimately succumb to~     the disease. While a very small number of patients qualify for aggressive treatment with~     surgery, chemotherapy and radiation, and enjoy long-term survival, the vast majority of~     patients have incurable disease. The treatment options currently available, including~     chemotherapy and radiation treatment, are only modestly effective at alleviating symptoms and~     improving life expectancy. This trial explores the use of new radiation technology~     (tomotherapy), to treat mesothelioma more aggressively than has been possible before.~     Tomotherapy's ability to treat unusual shaped tumours, particularly when they are wrapped~     around sensitive normal tissues (the lung), enable higher doses of radiation to be used and~     this may improve its effectiveness. We will treat 17 patients with tomotherapy and assess the~     breathing, symptoms, and quality of life of the patients before and after treatment~   "
235797|NCT00469183|"~     Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through~     biopsy examination.~   "
235798|NCT00469170|"~     The proposed study is a multi-centre, open-label crossover study to assess the safety and~     acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a~     12 week period in 200 healthy, sexually active women.~   "
235799|NCT00469157|"~     To assess the compatibility of Optive with refractive surgery (PRK and LASIK)~     post-operatively.~   "
235800|NCT00469144|"~     The goal of this clinical research study is to learn if giving busulfan in a dose based on~     blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and~     causes fewer side effects for AML or myelodysplastic syndrome patients than the standard~     method of giving a fixed busulfan dose based on body size, along with a fixed dose of~     fludarabine. The safety of dosing based on blood levels will also be studied.~   "
235801|NCT00469131|"~     The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that~     of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver~     transplantation.~   "
235826|NCT00468806|"~     The purpose of this study is to look at how much of a new drug, GSK598809 binds to specific~     proteins in the brain and how much stays in the blood over a range of different doses.~   "
235802|NCT00469118|"~     This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment of~     low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing a~     standardized clinical research multimodal protocol. During the first two weeks subjects are~     randomized to receive either conservative care or DRX treatment first and then cross over to~     receive either conservative care or DRX treatment the next 6 weeks. This study will test the~     hypothesis that standardized 6-week treatment regimen of spinal decompression using DRX9000™~     will reduce chronic lower back pain more than conservative therapy (current baseline~     therapy).~   "
235803|NCT00469105|"~     The aim of this research will be to perform a small randomized controlled trial (RCT) of a~     new diabetes educational intervention that teaches self-management skills that compensate for~     poor numeracy skills among a sample of primary care patients with type 2 diabetes and low~     literacy and/or numeracy.~   "
235804|NCT00469092|"~     This trial is conducted in Africa, Asia, Europe, Oceania and South America.~      This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin~     glargine once daily all in combination with metformin and glimepiride in insulin naive~     subjects with type 2 diabetes.~   "
235805|NCT00469079|"~     The use of smokeless tobacco (ST) as a substitute for cigarette smoking has been suggested~     since it is considered by some to be a less harmful tobacco product (Russell, Jarvis and~     Feyerabend, 1980; Russell et al, 1981; Rodu, 1994). ST does not have the volatile~     constituents and carbon monoxide (CO) that are found in cigarette smoke. Since ST is not~     smoked there would be less risk of cardiovascular and lung disease. In addition the harm~     associated with second hand smoke would be eliminated. Although the health risks are reduced~     in ST users, they still exist due to the presence of nitrosamines found in ST. A better~     approach would be to use nicotine replacement that did not contain carcinogens, however the~     cost of such NRT could be prohibitive especially in third world countries where the rate of~     smoking is continuing to rise and the per capita income is much lower than in the United~     States.~      Purpose: The goal of this study is to evaluate the health effects of Camel Snus, the new oral~     tobacco product produced by RJ Reynolds and Taboka, produced by Phillip Morris. These~     products are pasteurized rather than fermented and contain less moisture to eliminate~     spitting. They are marketed as an alternative to cigarette smoking.~   "
235806|NCT00469066|"~     To study changes in tumor and normal organ size and/or position which occur during a course~     of radiation treatments.~   "
235807|NCT00469053|"~     The purpose of this study is to determine whether two different analgesic transdermal patch~     formulations lead to same plasma levels of active ingredient after multiple dose application.~   "
235808|NCT00469040|"~     GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic~     obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness~     because the small tubes (bronchioles) that carry air in and out of the lungs become narrow.~     We hope that the study medicine will work by relaxing the muscles in the airways and help to~     keep the airways open, and make breathing easier. The study medicine might improve on~     available treatments by having fewer side-effects, and by working faster and for longer, so~     that patients could take it once daily, instead of twice daily.~      When a medicine is made into a form ready to be given to patients, inactive ingredients are~     often added. Inactive ingredients might be used to help a medicine work better, to make it~     easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In~     this study, the study medicine contains the inactive ingredient magnesium stearate.~      We need to check that the study medicine doesn't cause problems when inhaled along with~     magnesium stearate. So, we're doing this study in healthy people to find out the answers to~     these questions.~      1)Do repeated once-daily doses of the study medicine cause any important side effects when~     inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine~     gets into the bloodstream and how long does the body take to get rid of it?~   "
235809|NCT00469027|"~     The primary objective is to establish the safety of autologous progenitor cell-based gene~     therapy of heNOS in patients with severe Pulmonary Arterial Hypertension(PAH) refractory to~     conventional treatment.~   "
235810|NCT00469014|"~     The goal of this clinical research study is to find the best dose of clofarabine and~     fludarabine that can be given with busulfan followed by an allogeneic blood stem cell~     transplant. Researchers will study whether this combination can help to control the disease,~     and look at the safety of this combination. Researchers also want to find out if combining~     busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine~     will improve the treatment, compared with the previous standard method using busulfan and~     fludarabine alone.~   "
235811|NCT00469001|"~     To use continuous measurement of NT Pro BNP level as guide in therapy patients with CHF.~   "
235812|NCT00468988|"~     Compare the effect of Xalatan with benzalkonium chloride on the ocular surface to those~     effects observed with Travatan Z without benzalkonium chloride after a single dose~   "
235813|NCT00468975|"~     A study to determine the ability of different doses of PF-610,355 to open the airways in~     asthmatic patients by comparison with placebo and a marketed drug that also opens the airways~     in asthmatic patients.~   "
235814|NCT00468962|"~     Functional properties of chitooligosaccharides have been studied for antitumor activity,~     immunostimulating effects, antimicrobial activity, free radical scavening activity, adn~     angiotensin I converting enzyme inhibitory activity. Recent in vitro, and in vivo toxicity~     and absorbability studies have demonstrated that chitooligosaccharides have high~     absorbability and are essentially non-toxic. In the present study, we prepared a~     chitooligosaccharide with high absorbability and evaluated its effects on activation of~     immune function and cardiovascular funciton(lipid, atrial stiffness, etc) in healthy adults.~      This study was a 8-week, randomized, double-blind clinical trial. The 30 volunteers were~     divided into a control group(n=10), half dose chitooligosaccaride(FACOSTM) intake~     group(n=10), and full dose FACOS intake group(n=10). Peripheral blood mononuclear~     cells(PBMCs) were isolated and cultured in 12 well plate for 48 hours. Cytokine production by~     PBMCs pre- and postintervention were measured simultaneously after stimulation with~     lipopolysaccaride.~   "
235880|NCT00468091|"~     The purpose of this study in humans is to define the effects of the endogenous hormone GLP-1~     on gastroduodenal motility and on endocrine pancreatic secretion by using the specific GLP-1~     receptor antagonist exendin(9-39). To elucidate possible cholinergic pathways, we combined~     exendin(9-39) with the muscarinergic antagonist atropine.~   "
235815|NCT00468949|"~     Main Research Questions:~      We want to measure the change in quality of life in Dupuytren's disease patients who do and~     do not undergo surgery. Also, we want to test the validity of health related quality of life~     measurements in patients with Dupuytren's disease.~      Why is this research important? Some patients with Dupuytren's contracture require excision~     surgery or palmar fasciectomy. Other patient's with Dupuytren's contracture do not require~     surgery; however, these patients may need surgery in the future. No studies have reported the~     health-related quality of life of patients with Dupuytren's disease whether related to~     surgical intervention or not.~      What is being studied? We are studying the difference and change in health-related quality of~     life in patients suffering from Dupuytren's disease who require excision surgery and do not~     require surgery.~   "
235816|NCT00468936|"~     Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent~     form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS)~     questionnaire. Those who score three or more on at least two questions are eligible for the~     study. Once they sign a study consent they are randomized to one of two arms. It is thought~     that the severity of GI side effects will be reduced over time in patients who are in the~     Myfortic arm versus the severity of GI side effects over time in patients who remain on MMF~     treatment. Patients are evaluated by GSRS, The Psychological Well-Being Schedule, and the~     IT01/02 Checklist for the evaluation of GI symptoms and followed for one year (visits 1~     month, 3 months, 6 months, 12 months).~   "
235817|NCT00468923|"~     Heart disease and stroke are major causes of death and disability worldwide and are largely~     preventable. Cholesterol and blood pressure are major cardiovascular risk factors. Previous~     studies have shown that certain drugs can effectively and safely lower cholesterol and blood~     pressure and prevent heart attacks and strokes. Such studies have been conducted primarily in~     people who had already sustained a heart attack or a stroke, or in people with high~     cholesterol and blood pressure levels. However, most heart attacks and strokes occur in~     people with average (normal) cholesterol and blood pressure. Therefore, in the HOPE-3 trial~     the investigators will evaluate whether a cholesterol lowering drug, rosuvastatin, and a~     combination blood pressure lowering pill, candesartan/hydrochlorothiazide, used alone or~     together can reduce the risk of heart attacks, stroke and their sequelae in people without~     known heart disease and at average risk.~   "
235818|NCT00468910|"~     This randomized phase II trial is studying how well aspirin works in preventing colorectal~     cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of~     certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.~   "
235819|NCT00468897|"~     The present pharmacokinetic study is designed to compare bioavailability and assess~     bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both~     formulations will be tested in fasting healthy volunteers~   "
235820|NCT00468884|"~     Context: Oral formulations of GLP-1 and PYY3-36, two satiety peptides, were studied. An oral~     delivery system would be preferable in many of the possible therapeutic indications of these~     peptides.~      Objectives: Our objective was to establish the pharmacological profile of increasing oral~     doses of GLP-1 and PYY3-36 in healthy volunteers. In addition, the pharmacological effects of~     GLP-1 were investigated.~      Setting: Single center escalating dose study with oral applications. Subjects and Methods: In~     the first part, GLP-1 was given orally to 6 male subjects; the treatment consisted of one of~     the following oral doses of either GLP-1 (0.5, 1.0, 2.0 and 4.0 mg) or placebo. In the second~     part, PYY3-36 was given orally to another 6 healthy male subjects; the treatment consisted of~     one of the following oral doses of either PYY3-36 (0.25, 0.5, 1.0, 2.0 and 4.0 mg) or~     placebo.~   "
235821|NCT00468871|"~     This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and~     efficacy study. The aim of this study is to evaluate the effect of an intravitreal~     fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with~     unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.~   "
235822|NCT00468858|"~     The purpose of this study is to evaluate the safety and effectiveness of two different~     formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two~     doses are given six months apart to adults and children.~   "
235823|NCT00468845|"~     To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy ,~     measured using subject reported assessments of pain.~   "
235824|NCT00468832|"~     The purpose of this study is to establish the largest long-term assessment of people with~     Duchenne muscular dystrophy (DMD). In this study, the investigators associated with the~     Cooperative International Neuromuscular Research Group CINRG) will take a detailed look (for~     a minimum of eight years) at DMD participant's physical abilities, the medical problems they~     experience, and how they use health care services. Physical abilities will be compared to a~     group of healthy controls.~      The second purpose of this study is to find out whether small, normal differences in the~     genetic makeup of people with DMD (called single nucleotide polymorphisms or SNPs) affect~     how their disease progresses and relates to muscle strength/size and steroid response.~      The third purpose of this study is to study genetic variations associated with DMD.~      The final purpose of this study is to determine whether certain biomarkers are present in~     people with DMD and not in healthy controls.~   "
235825|NCT00468819|"~     In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has~     already been approved for application in adults, will be investigated in children and~     adolescents. MRI is a modern and safe examination method without delivering radiation burden~     using magnetic fields to produce cross-sectional images of the human body. A special computer~     program then puts these images together and creates a two or three-dimensional image of the~     inner organs thus facilitating the detection and evaluation of pathological changes. In~     contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the~     examination which results in a stronger contrast in the examined area. Therefore,~     pathological changes can be more easily detected and evaluated compared to non-enhanced MRI.~     The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called~     Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine.~     Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e.~     in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney~     disease. Gadavist was examined in more than 2,900 adults within the framework of clinical~     studies during development and has been used after its marketing authorization in meanwhile~     more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only~     conducted with adults so far. Diseases requiring MRI examinations, however, often occur in~     children, too. Therefore, many contrast agents are already used on a regular basis in MRI~     examinations of children, some of these contrast agents being authorized already. Within the~     framework of this study the pharmacokinetic characteristics of Gadavist in children or~     adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in~     the body. In addition, safety and tolerability will be evaluated in order to demonstrate that~     Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents.~     Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body~     weight also for this population group.~   "
235827|NCT00468793|"~     Perioperative goal directed fluid therapy by means of an esophageal doppler has been shown to~     reduce morbidity and length of stay. In this study patients undergoing elective bowel surgery~     will be randomised to traditional fluid therapy with crystalloids versus fluid boluses guided~     by central venous oxygen saturation. The primary outcome will be complications after surgery.~   "
235828|NCT00468780|"~     The objective of this study is to evaluate the reliability and validity of acuity estimates~     by paramedics employing the Canadian Triage Acuity Scale (CTAS) in the out of hospital~     setting. The study has the potential to help guide policy decisions pertaining to the safe~     transfer of ambulance patients to alternative destinations reducing ED overcrowding and~     ambulance off load time. Emergency Department triage nurses employ the same acuity scale and~     if this study is successful the emergency departments and the EMS services could communicate~     about capacity to handle patients based on acuity, volumes and waiting times.~   "
235829|NCT00468767|"~     This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion~     of atrial fibrillation to sinus rhythm.~   "
235830|NCT00468754|"~     This trial will compare the metabolic control in type 1 diabetes obtained by continuous~     infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro~     and glargine, a long-acting insulin analogue. Patients will be switched to the alternative~     treatment after 4 months. Glucose variability in the last month of each treatment will be~     analyzed.~   "
235831|NCT00468741|"~     Component and Couple Analysis of Cancer Communication~      CHESS, the Comprehensive Health Enhancement Support System is an innovative technology that~     provides information, social support and skills training to women with breast cancer.~     Previous CHESS clinical trials found improved patient outcomes but little is known about what~     services in CHESS produce those results. This study will examine whether breast cancer~     patient outcomes change when conceptually distinct CHESS services (information, social~     support, and skills training) are systematically added to a patients treatment resources.~      Primary Aims:~        -  Determine the relative efficacies of different types of cancer communication treatments~          when they are presented alone or in combination~        -  Determine routes or processes via which these elements work~        -  Determine for whom the different treatment types work best.~   "
235832|NCT00468728|"~     This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80~     (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea~     (CDAD).~   "
235833|NCT00468715|"~     RATIONALE: Androgens can cause the growth of breast cancer cells. Antihormone therapy, such~     as bicalutamide, may stop the adrenal glands from making androgens.~      PURPOSE: This phase II trial is studying how well bicalutamide works in treating patients~     with metastatic breast cancer.~   "
235834|NCT00468702|"~     This study will measure the efficacy and safety of an early postoperative anticoagulation~     self-management program, using the CoaguChek S device, in patients undergoing mechanical~     valve replacements. Patients will be randomized into a study group (self-management) or a~     control group (physician management).~   "
235835|NCT00468689|"~     This study will evaluate the safety, tolerability and exposure of SB-751689 when administered~     alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a~     PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable~     the planning and conduct of a QTc study for SB-751689.~   "
235836|NCT00468676|"~     This study will evaluate the effectiveness of a nurse-led case management intervention in~     improving disease control and depression symptoms in adults with diabetes and/or heart~     disease who are also depressed.~   "
235837|NCT00468663|"~     An epidemiologic study of pregnant women in western Washington to measure the relationships~     between exposure to air pollutants and risks of preeclampsia and preterm delivery.~   "
235838|NCT00468650|"~     A multicenter open label study to assess the efficacy of sildenafil rapid dose titration to~     100 mg in men with erectile dysfunction, based on the Erectile Function (EF) domain score of~     the International Index of Erectile Function (IIEF) questionnaire.~   "
235839|NCT00468637|"~     The purpose of the study is to evaluate the influence of cardiovascular risk factors, heart~     failure and cardiovascular drug therapy on erectile function in cardiovascular high-risk~     patients.~   "
235840|NCT00468624|"~     Approximately 50% of middle-aged patients with severe AGHD have a normal age-related serum~     IGF-I. It remains unclear if in these individuals serum IGF-I is GH dependent or independent.~     This study compared the relationship between GH and serum IGF-I in two cohorts of male~     patients with severe AGHD; one with normal and the other with subnormal age-related serum~     IGF-I values. The GH receptor antagonist - pegvisomant was be used to specifically inhibit GH~     action and the changes in markers of the GH axis, such as serum IGF-I, IGFBP-3, GH and GHBP~     were measured.~   "
235841|NCT00468611|"~     This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects~     with Secondary Progressive Multiple Sclerosis (SPMS)~   "
235842|NCT00468598|"~     This survey has two aims. First, we would like to be informed about the health condition of~     our patients two years following heart surgery at University Hospital, Basel. Second, we are~     interested in determining whether a patient's long-term outcome can be predicted by the~     analysis of blood samples taken shortly after heart surgery.Troponin T, the blood parameter~     that we are interested in, is routinely assessed in the Intensive Care Unit. The purpose of~     this survey is to determine whether or not it is also possible to infer the long-term outcome~     from this blood parameter.~   "
235859|NCT00468364|"~     Long-acting insulin injected at bedtime may cause hypoglycemia (low blood sugar) in the night~     in patients with diabetes. The aims of the study are 1) to compare the dynamic~     characteristics of long-acting insulin analog glargine with those of NPH insulin and placebo~     during the night and the early morning hours, 2) investigate differences on glucose~     metabolism of bedtime glargine versus NPH insulin at induced hypoglycemia.~   "
235877|NCT00468130|"~     Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and~     irritability in autistic individuals as shown by reductions in the Aberrant Behavior~     Checklist-irritability subscale.~      (2) Aripiprazole treatment will be superior to placebo in the acute treatment of global~     autism severity.~      The purpose of this study is to examine the possible benefit of the medication Aripiprazole~     in autistic individuals.~   "
235843|NCT00468585|"~     The purpose of this study is to find out what effects (both good and bad) that capecitabine~     has on you and your breast cancer when given in a novel schedule in combination with the~     antibody therapy, bevacizumab. Capecitabine (Xeloda®) is an anticancer drug that was approved~     by FDA in 1998 for treating metastatic breast cancer. Capecitabine is a pill that blocks the~     way cancer cells multiply and grow. Usually, this medicine is taken twice a day for fourteen~     days in a row.~      Patients then get a break from the drug for seven days. With this schedule and usual dose,~     some patients on capecitabine have experienced side effects that interfered with their daily~     comfort.Different doses and schedules of capecitabine have been studied in animal studies and~     in people with colon cancer. Mathematic modeling has been used to better understand these~     results.Information from these experiments leads us to ask if 7 days of treatment with~     capecitabine followed by a 7-day break is both safer and more active against breast cancer.~     The study you are considering is a first step in this direction and is designed to~     demonstrate both safety and activity.~      Bevacizumab is a biologic therapy that targets the growth of blood vessels which tumors need~     to grow. Women whose breast cancer spread to other parts of their bodies lived longer without~     their cancers growing when they were treated with bevacizumab and chemotherapy. Bevacizumab~     was tested with the 14-day/7-day schedule of capecitabine. These two medicines are safe when~     given together and seem to work better against breast cancer than capecitabine alone.~      This study is designed to answer the questions:~        1. What are the side effects of bevacizumab and capecitabine when given in this different~          schedule and how often do they occur?~        2. When given in this schedule, does capecitabine with bevacizumab help treat breast cancer~          that has spread or continues to grow despite being treated by other chemotherapy drugs~          before?~   "
235844|NCT00468572|"~     This study will examine the effects of tending to significant social relationships on~     managing and reducing stress.~   "
235845|NCT00468559|"~     The purpose of this study is to look at the improvement of a once a day dose of esomeprazole~     for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD).~     This research study consists of a screening, open-label, and double-blind treatment~     withdrawal phase. The screening phase ensures the patient eligibility. No study medication is~     dispensed during the screening phase. During the open-label phase, patients are administered~     esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase,~     the patients are administered either his/her open-label dose or placebo. Double-blind means~     neither the physician, parent, or patient will know if patient is taking esomeprazole or~     placebo. The patient will have an equal chance of receiving esomeprazole or placebo.~   "
235846|NCT00468546|"~     This study will assess the safety and efficacy of rituximab combined with MTX in participants~     with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor~     Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the~     target sample size is 500 participants. Eligible participants may receive re-treatment with~     rituximab under a separate protocol WA17531.~   "
235847|NCT00468533|"~     A short term post-market monitoring of serum prolactin level change among patients with~     schizophrenia shifting from other antispychotics to different dosages of aripiprazole.~   "
235848|NCT00468520|"~     The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening.~     It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption~     that the combination results in a more successful labor induction. Scientific validation of~     this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves~     induction success.~   "
235849|NCT00468507|"~     Patients undergoing major surgery, trauma and burns are prone to develop an exacerbated~     inflammatory response, which is potentially lethal to the individual. Recently our group~     demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates~     severe inflammation, gut barrier loss and hepatic damage. High fat feeding releases~     cholecystokinin in the gut, which stimulates the autonomous nervous system and subsequently~     activates the efferent vagus nerve. The activated efferent fibers inhibit tissue macrophages~     via binding of acetylcholine to the alpha7-nicotinergic receptor.~      In this study the cholecystokinin release in healthy volunteers is monitored in response to~     low fat and high fat food products.~   "
235850|NCT00468494|"~     Surgery performed during general anesthesia induces a stress effect on the body. Our plan is~     to identify population at risk of hyperglycemia during perioperative period.~   "
235851|NCT00468481|"~     The purpose of this study is to determine whether the study drug is safe and effective~   "
235852|NCT00468468|"~     Mentor Integration Project~      This study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential~     additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for~     women diagnosed with breast cancer. Our goal is to advance interactive cancer communication~     systems, thus improving quality of life for patients and families facing cancer, especially~     underserved populations.~      Primary Aims:~        -  Determine if the Internet, CHESS, a Cancer Mentor, or a combination of CHESS and the~          Cancer Mentor improve quality of life for women with breast cancer~        -  Determine which of the above conditions is most effective~        -  Determine which of the above conditions is most cost efficient~   "
235853|NCT00468455|"~     The purpose of this study is to produce a user-friendly tool- in the form of a questionnaire~     - to accurately assess early quality of life in patients after abdominal colorectal surgery~     from the first day after surgery to 6 months after. The study will also compare this~     questionnaire to the other currently available assessment tools. Patients are invited to~     participate if they are undergoing abdominal colorectal surgery at University Hospitals of~     Cleveland.~   "
235854|NCT00468442|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells~     are destroyed, resulting in poor blood sugar control. The purpose of this study is to~     determine the safety and effectiveness of islet transplantation, combined with the~     immunosuppressive medications and medications to support islet survival for treating type 1~     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic~     episodes.~   "
235855|NCT00468429|"~     This study analyzes the safety and efficacy of off-label Subconjunctival Injection of~     bevacizumab (Avastin) versus 0.02% mitomycin C (MMC) for preventing bleb failure following~     glaucoma filtration surgery.~   "
235856|NCT00468416|"~     The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device~     in the creation of colorectal anastomosis~   "
235857|NCT00468403|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells~     are destroyed, resulting in poor blood sugar control. The purpose of this study is to~     determine the safety and effectiveness of islet transplantation using a steroid-free,~     calcineurin-inhibitor-free belatacept based immunosuppressive medication, for treating type 1~     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic~     episodes.~   "
235858|NCT00468390|"~     To evaluate the effect of capsaicin in patients with Complex Regional Pain Syndrome.~   "
235860|NCT00468351|"~     Intravitreal triamcinolone has been effective for central macular thickness reduction and~     concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is~     a very effective inducer of permeability, being 50.000 times more potent than histamine, and~     may exert its effect on retinal vascular permeability by altering tight-junctions proteins,~     such as occluding and VE-cadherin. Based on these principles, there is a rationale for~     anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as~     diabetic macular edema. Therefore, we conducted a randomized, prospective study to compare~     the efficacy and safety of intravitreal triamcinolone acetonide and intravitreal bevacizumab~     injection for refractory diffuse DME.~   "
235861|NCT00468338|"~     The BIS monitor is a tool which assists anesthesiologists in monitoring the depth of~     anesthesia or level of anesthesia. The study doctors would like to see if it is useful tool~     for patients who are mentally challenged and require anesthesia.~   "
235862|NCT00468325|"~     This is a prospective, randomized multicenter trial comparing MSCT to standard of care (SOC)~     diagnostic treatment in the triage of Emergency Department (ED) low to intermediate risk~     chest pain patients. Our hypotheses are that compared to SOC treatment, MSCT is equally safe~     and diagnostically effective, as well as more time and cost efficient.~   "
235863|NCT00468312|"~     This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS)~     once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in~     reducing the total symptom score.~   "
235864|NCT00468299|"~     The purpose of this study is to compare two combinations of drugs (mifepristone and~     misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy~     failure. We will compare the two combinations of medications to see which combination makes~     miscarriage happen faster. We hypothesize that there will be no difference in time to~     complete miscarriage between the two groups.~   "
235865|NCT00468286|"~     The study will have two treatment groups, evaluating two Degarelix doses. First dose is the~     initial dose followed by a maintenance dose given every three months. The initial dose given~     to suppress the testosterone level and the three month maintenance dose to maintain the~     suppressed testosterone level over one year of treatment.~   "
235866|NCT00468273|"~     The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune~     Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary~     immunodeficiency diseases.~   "
235867|NCT00468260|"~     To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with~     advanced malignancies.~   "
235868|NCT00468247|"~     A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided~     Circulatory Management System versus conventional care in post-operative cardiac surgery~     patients. The purpose of the study is to demonstrate that the real time acquisition and~     subsequent processing and display of data produced by the Navigator guided circulatory~     management system provides the clinician with appropriate data and guidance to achieve and~     maintain a prescribed target haemodynamic stability in the post operative patient when~     compared to conventional care in an Intensive Care Unit setting.~   "
235869|NCT00468234|"~     The proposed study will evaluate biomarkers measured in exhaled breath condensate (EBC) for~     the purpose of assessing clinical strategies of harm reduction. It will take advantage of a~     recently developed device that permits collection of exhaled breath condensate reproducibly,~     with minimal subject effort and with no oral contamination. The major goal of the trial is to~     provide evidence to validate biomarkers in EBC.~      This will be accomplished by collecting samples from asymptomatic smokers before and after~     inducing a change in their smoking habit (cessation or reduction) with the aid of partial~     nicotine replacement.~      Measures to be made in EBC include H2O2, the most widely explored biomarker in this body~     fluid. Methods that reliably can quantify levels in normal non-smokers and in asymptomatic~     smokers will be used. Two fold increases in smokers have been reported by in several reports~     and confirmed in preliminary data by the investigators. In addition, other biomarkers of~     oxidant stress: TBARs, 8-isoprostane and nitrotyrosine will be quantified using standard~     methods.~      Biomarkers quantified in EBC will be assessed for reliability (i.e. reproducibility and for~     sensitivity) to change and for validity (by comparison to clinically defined endpoints and~     previously validated measures of exposure). Reproducibility will be assessed by making~     repeated measurements in the same subjects on different occasions. Sensitivity to change will~     be assessed by comparing values before and after changing smoking habit. Finally, the~     validity of the biomarkers will be assessed by comparing them to previous measures of smoke~     exposure (CO, NNAL and NNAL-glc) and to clinically defined endpoints: symptoms, the St.~     George's Respiratory Questionnaire and post bronchodilator lung function. With regard to the~     latter measures, preliminary data indicate that symptoms can be detected in asymptomatic~     smokers and that these can change with a harm reduction strategy.~   "
235870|NCT00468221|"~     The purpose of this research study is to learn more about the effects of 0.12 ppm ozone~     exposure on humans. We know from other studies that exposure to levels of ozone that are seen~     on bad air pollution days, can cause an increased risk of illness and even death in some~     people with certain health problems like asthma and heart disease. We also know from studies~     we have done in our lab that even healthy people can have an inflammatory (an increase in the~     amount of bacteria fighting cells) response to high levels of ozone. We suspect that exposure~     to low levels of ozone makes the body more susceptible to things like allergens. For~     instance, in persons allergic to pollen, exposure to ozone in the environment may cause them~     to have more allergy symptoms when they are around pollen than they would have if they were~     not exposed to ozone first. In this study we are looking to find the lowest level of ozone to~     which healthy people can be exposed without seeing that increased immune response. We will~     use 0.12 ppm ozone; this is roughly the amount of ozone you would be exposed to on a yellow~     ozone day in the triangle area in the summer if you spent the entire day out of doors and~     exercising moderately.~   "
235871|NCT00468208|"~     Wegener's granulomatosis (WG) is a rare disease that causes inflammation of blood vessels, or~     vasculitis. It may involve many different parts of the body, but typically affects the upper~     and lower respiratory tract and kidneys. The purpose of this study is to determine the safety~     and effectiveness of the medication abatacept in treating adults with mild relapsing WG.~   "
235872|NCT00468195|"~     The purpose of this cardiovascular imaging research is to look at ways to improve the way we~     can look at the pictures of the heart. Patients undergo CT scans of the heart for a variety~     of reasons, including symptoms and/or tests suggestive of coronary artery disease (chest~     pain, shortness of breath, abnormal stress test, follow up exam of known/existing coronary~     disease, abnormal calcium score, etc.) This study involves finding ways to optimize quality~     of the scan in persons of size. This is because in patients with a BMI (body mass index) of~     greater than 40, it is usually difficult to see all the arteries around the heart~     satisfactorily. Body mass index is a number that we can get by putting your height and weight~     in a formula. The purpose of this study is to use a new computer software program to help us~     interpret your heart study.~   "
235882|NCT00468065|"~     The objective of this study is to evaluate the effectiveness of the VeinViewer® near infrared~     device to facilitate the placement of intravenous catheters in children who require~     intravenous cannulation in the pediatric emergency department. This clinical protocol is~     designed to determine whether using the VeinViewer increases the ease and efficiency of IV~     cannulation (as perceived by the operator), decreases the time to effective cannulation,~     decreases the number of sticks and extravasations, and decreases the child's and the parents~     perception of the pain of IV cannulation.~   "
235883|NCT00468052|"~     Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery~     carried out in children who very often also present with obstructive sleep apnea. To provide~     pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl.~     These narcotics are known to depress respiration and to increase the incidence of~     post-operative nausea and vomiting. These side effects are worrisome in this patient cohort.~     An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high~     safety profile in adults as well as in sedation in children. The purpose of this study is to~     determine if intravenous dexmedetomidine given as an infusion during general anesthesia for~     tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence~     agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following~     surgery.~   "
235884|NCT00468039|"~     This study will evaluate the effects of treatment with vildagliptin and metformin as initial~     combination in newly diagnosed patients with type 2 diabetes who have very high levels of~     HbA1c and/or fasting plasma glucose.~   "
235885|NCT00468026|"~     The purpose of this ex-vivo study is to evaluate the insertion procedure for the ProstaPlant~     implant in human prostates and the support that it supplies to the prostate.~   "
235886|NCT00468013|"~     In this study 60 people with medically unexplained physical symptoms (MUPS) will receive~     either a 6-session resilience skill building intervention provided fully online or a weekly~     computerized journaling assignment. Both programs can be completed from home. Participants~     will complete questionnaires both before and after the intervention and changes in symptoms,~     mood and satisfaction with life will be assessed.~   "
235887|NCT00468000|"~     This study is designed to evaluate the safety and efficacy of autologous Vascular Repair~     Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb~     ischemia.~      The double-blind study is expected to enroll 150 patients, randomized into two patient~     groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the~     affected limb; the control group will receive intramuscular injections with an electrolyte~     solution (without cells). Both groups will receive the standard of care appropriate for their~     medical condition.~   "
235888|NCT00467987|"~     The purpose of this study is to examine the effects of testosterone deficiency in men with~     diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .~   "
235889|NCT00467974|"~     The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety~     and efficacy of LEM as compared to TACE for treating patients with unresectable HCC.~   "
235890|NCT00467961|"~     This study will try to improve the safety and effectiveness of stem cell transplant~     procedures in patients with cancers of the blood. It will use a special machine to separate~     immune cells (T cells) from the blood of both the donor and the patient and will use~     photodepletion, a laboratory procedure that selectively kills cancer cells exposed to light.~     These special procedures may reduce the risk of graft-versus-host-disease (GVHD), a serious~     complication of stem cell transplants in which the donor's immune cells destroy the patient's~     healthy tissues, and at the same time may permit a greater graft-versus-leukemia effect, in~     which the donated cells fight any residual tumor cells that might remain in the body.~      Patients between 18 and 75 years of age with a life-threatening disease of the bone marrow~     (acute or chronic leukemia, myelodysplastic syndrome, or myeloproliferative syndrome) may be~     eligible for this study. Candidates must have a family member who is a suitable tissue match.~   "
235891|NCT00467948|"~     Patients who need major head & neck surgery are at risk of post operative wound infection. In~     spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has~     been well documented, controversy exists in the optimal antibiotic regimen~   "
235892|NCT00467935|"~     This is a trial aimed at patients with advanced wet macular degeneration and macular scarring~     treated wiht intravitreal injections of Lucentis.~   "
235893|NCT00467922|"~     The purpose of this study is to find out if guided fluid administration with the esophageal~     monitor is superior to standard fluid administration and whether use of the hetastarch or~     lactated ringers offers different benefits with respect to length of stay in the hospital~     after hand-assisted colorectal surgery.~   "
235894|NCT00467909|"~     Nutritional deficiencies are a major problem in school children in India and have a variety~     of adverse effects on their cognitive development and growth, and increase susceptibility to~     infections. There is strong evidence for beneficial effects of iodine, iron and~     protein-energy on cognitive development in children, while evidence for vitamin B6, vitamin~     B12, folate, zinc and, omega-3 fatty acids and in particular docosahexanoic acid (DHA) is~     limited and inconclusive. A randomised, double-blind, placebo-controlled 2x2 factorial design~     will be conducted to assess the effect of a micronutrient with or without omega-3 fatty acids~     on cognitive development and performance and other selected outcome variables such as growth,~     morbidity and immune response in children of 7-9 years of age in India.~   "
235895|NCT00467896|"~     A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution~     delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 Power 15 Study~   "
235896|NCT00467883|"~     Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy~     will be defined as objective responses; complete and partial response.~   "
235897|NCT00467870|"~     To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of~     serum total testosterone.~   "
235898|NCT00467857|"~     The purpose of this study is to determine if there is a qualitative reduction in microbial~     skin flora post-surgery compared to pre-surgery when a cyanoacrylate based microbial sealant~     is used in combination with a surgical skin preparation solution.~   "
235899|NCT00467844|"~     The purpose of this study is to assess if Gtx-024 is effective in increasing lean body mass~     in subjects with muscle wasting related to cancer.~   "
235900|NCT00467831|"~     This study will examine whether five drugs (pravastatin, Losartan, Zileuton, N-acetylcysteine~     and erythromycin) used together can slow the course of pulmonary fibrosis (scarring of the~     lung tissue) in patients with Hermansky-Pudlak Syndrome (HPS). Patients with this disease~     have decreased skin color (albinism), bleeding problems, and sometimes colon problems. Two of~     the known types of Hermansky Pudlak syndrome, type 1 and type 4, are at high risk of~     pulmonary fibrosis between the ages of 30 and 50.~      Patients 18 to 70 years of age who have Hermansky-Pudlak Syndrome with a serious loss of lung~     function due to pulmonary fibrosis may be eligible for this study.~      Participants begin taking pravastatin on study day 2 and start a new drug every 3 days.~     Patients who experience no problems with the medicines return home and continue on the drugs~     for the next 2 years. They return to the NIH Clinical Center every 3 months for a medical~     history, physical examination, and blood, urine and lung function tests. CT and bone density~     scans are done every year. The study may continue for up to 3 years.~   "
235901|NCT00467818|"~     Published studies on omega 3 fatty acids in the treatment of bipolar disorder and~     schizophrenia have shown reductions in time to recurrence, a decrease in the positive and~     negative symptoms of schizophrenia, and improvements in CGI, YMRS, and HAM-D scores. The~     following are the hypotheses:~        -  Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism.~        -  Omega 3 fatty acids will be superior to placebo in improving aggression and irritability~          associated with autism.~        -  Omega 3 fatty acids will be superior to placebo in improving functional ability.~   "
235902|NCT00467805|"~     The study investigates an acute effect of white-appearing LED light (with a peak in blue~     portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.~   "
235903|NCT00467792|"~     The purpose of this study is to determine how long the skin lesions usually last and what~     kind of symptoms and signs children with urticaria pigmentosa may develop over the years.~     This information will allow physicians to better care for patients who have been diagnosed~     with this disease and to provide their parents with more complete information regarding what~     to expect for the future of their child. This research is being done because many unanswered~     questions remain regarding children with urticaria pigmentosa and its course.~   "
235904|NCT00467779|"~     This non-randomized, open-label, study will determine the highest safe dose of cobimetinib,~     how often it should be taken, how well participants with cancer tolerate cobimetinib and will~     assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.~   "
235905|NCT00467766|"~     A unique multinational study was conducted simultaneously in the USA, England and Australia.~     The goals of the study were to answer two questions: Does psychosocial support for the family~     enhance the effectiveness of drug treatment for Alzheimer's disease? Is the added value of~     psychosocial support the same in all 3 countries?~   "
235906|NCT00467753|"~     The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine~     vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty~     subjects between the ages of five and seventeen with a diagnosis of autism.~   "
235907|NCT00467740|"~     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL~     inhalation solution delivered by the Respimat® inhaler for four weeks in patients with~     asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how~     well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount~     of the medication found in your blood).~   "
235908|NCT00467727|"~     To determine if diagnostic phase contrast mammography (PCM) will provide improved image~     detail in assessing lesion characteristics when compared to diagnostic x-ray mammography~     (XM).~   "
235909|NCT00467714|"~     The role of strut in rhinoplasty has been debated for many years and many research has been~     made over this problem but there is no significant data for descision of surgeon, so this~     study was designed to evaluate the effect of columellar strut in tip projection and rotation.~   "
235910|NCT00467701|"~     The aim of the study is to investigate the bacterial causes in community acquired pneumonia~     in adults admitted to hospital in two counties in Norway and to look at possible factors that~     makes the patients susceptible to pneumonia.~   "
235911|NCT00467688|"~     The objective of this cross over study is to access if continuous glucose monitoring (CGMS)~     with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only~     retrospective analysis of glucose values is able to improve course of glucose with special~     regard to time spent in hypoglycemic glucose ranges in type 1 diabetic patients with impaired~     hypoglycemia awareness or a history of severe hypoglycemia. The second objective is to access~     satisfaction with CGMS during both conditions~   "
235912|NCT00467675|"~     In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM)~     System to obtain 30 days of glucose measurements from 30 people with diabetes treated with~     insulin. The purpose of this study is to characterize glycemia (glucose) control in 30 people~     without diabetes and to compare these data to the 30 people with diabetes from a previous~     study. Through this approach it may be possible to develop a means of establishing a model of~     normal glucose patterns and a basis of comparison with glucose patterns in people with~     diabetes.~   "
235913|NCT00467662|"~     Recurrent cold sores - herpes simplex labialis (HSL) occurs in 20-40% of the US population~     and patient seek treatment because of the discomfort and visibility of the lesion although it~     is a self limiting disease. The purpose of this study is to check the safety, Efficacy and~     convenience of Use of the Natural Agent Superlysin Gel as Treatment for Herpes Labialis in~     Comparison to Acyclovir 5% and Docozanole 10%.~   "
235914|NCT00467649|"~     This will be a randomized, open label, parallel group, multicenter study. There will be two~     phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of~     regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients~     with type 2 diabetes who have either been on a prior regimen of insulin for less than 6~     months and were taking less than 50 U total of insulin per day OR are candidates for the~     initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore~     further intensification of diabetes regimens in patients failing to achieve HbA1c <=6.5% at~     Week 24.~   "
235915|NCT00467636|"~     The purpose of this study is to determine the effect of preventing hyperglycaemia in patients~     admitted to hospital with acute exacerbations of chronic pulmonary disease.~   "
235916|NCT00467623|"~     Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully~     elucidated how this is reflected in the total and cobalamin saturated transport proteins,~     transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin~     into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins~     and cobalamin analogues.~      Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd,~     39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo)~     was measured by in-house ELISA methods.~   "
235917|NCT00467610|"~     This is a Phase II, open-label clinical trial examining the role of Panhematin® in patients~     with MDS. The objective of this study is to evaluate the safety and efficacy of Panhematin®~     (hematin for injection) in the treatment of adult patients (≥ 18 years of age) with low-risk~     MDS.~      The study will be conducted on an outpatient basis and will consist of the following:~        -  A Screening Period (within 28 days of the Day 1)~        -  Screening bone marrow aspiration and biopsy up to 60 days prior to receiving study~          medication~        -  An 8-week Treatment Period (Days 1 through 4 of Week 1, and weekly visits during Weeks 2~          through 8); partial and complete responders in any of the three cell lines may continue~          treatment for an additional 4 weeks~        -  A 6-month Post treatment Follow-up Period (monthly clinic visits during Weeks 12 40)~   "
235918|NCT00467597|"~     The ultimate goal of this proposal is to reduce dyskinesia in Parkinson's Disease (PD)~     patients. Dyskinesias are abnormal movements, often caused by the standard treatment for PD~     symptoms, levodopa. In this study, we will test if biochemical devices are equal to the~     clinical rating system in measuring dyskinesias.~   "
235919|NCT00467584|"~     The purpose of this study is to determine whether aspirin is effective for treatment of~     fatigue caused by multiple sclerosis (MS).~   "
235920|NCT00467571|"~     Previous studies suggest that chronic idiopathic thrombocytopenic purpura is associated with~     Helicobacter pylori infection. The objective is to study the effect of Helicobacter pylori~     eradication on platelet count.~   "
235921|NCT00467558|"~     The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in~     compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will~     receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will~     be effective in reducing the urges to act out sexually in patients with compulsive sexual~     behavior. The proposed study will provide needed data on the treatment of a disabling~     disorder that currently lacks a clearly effective treatment.~   "
235922|NCT00467545|"~     This study is to evaluate the safety of telbivudine for up to 21 months of open-label~     treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial.~     Patients treated with telbivudine during core phase will continue telbivudine and patients~     treated with entecavir during core phase will be switched to telbivudine if the patient is~     willing to enroll this study.~   "
235923|NCT00467532|"~     The purpose of this study is to evaluate the effect of burn injury on the human immune system~     with a focus on cytomegalovirus (CMV) reactivation and the immunologic correlates of latent~     viral reactivation.~      Subjects will be patients admitted to the North Carolina Jaycee Burn Center with burn injury.~      Blood samples will be collected over time and will be evaluated for CMV reactivation and~     immune cell phenotype.~   "
235924|NCT00467519|"~     Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in~     US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection,~     booster response and safety of this formulation as a 5th dose.~      Primary Objective:~      - To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular~     pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all~     antigens) when each is administered as a 5th dose and given concurrently, to children aged 4~     to 6 years.~      Secondary/Observational Objectives:~        -  To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine~          (for pertussis antigens) when each is administered as a 5th dose and given concurrently,~          to children aged 4 to 6 years.~        -  To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after~          each long-term follow-up.~        -  To describe the safety profile following vaccine administration.~   "
235925|NCT00467506|"~     Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy~     using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with~     reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling~     time lower than 5 years)~   "
235926|NCT00467493|"~     Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent~     breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary~     for the production of estradiol. This class of drugs, aromatase inhibitors, are very~     effective in reducing estradiol levels in postmenopausal women and in treating estrogen~     receptor positive breast cancers. This study is examining the effect of a specific inhibitor,~     anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to~     estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial~     thickness. The main hypothesis is that anastrozole can be administered at any time during the~     menstrual cycle and reduce endometrial thickness compared to placebo.~   "
235927|NCT00467467|"~     To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms~     and quality of life.~   "
235928|NCT00467454|"~     The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in~     10 subjects with pyromania.~   "
235929|NCT00467441|"~     The purpose of this study is to determine the safety and efficacy of VSF-173 compared to~     placebo in treatment of induced excessive sleepiness.~   "
235930|NCT00467428|"~     The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in~     adult patients.~   "
235982|NCT00466752|"~     This phase II trial is studying sorafenib tosylate and gene expression in patients undergoing~     surgery for high-risk localized prostate cancer. Sorafenib tosylate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow~     to the tumor. Studying samples of blood and tumor tissues in the laboratory from patients~     with prostate cancer may help doctors learn more about changes that occur in DNA after~     treatment with sorafenib tosylate~   "
235931|NCT00467415|"~     The investigators are studying the effects of a 12-week exercise program, consisting of~     either:~        1. Walking on a treadmill with partial body weight~        2. Functional exercise program~      The investigators would like to know the effects these two exercise programs have on the~     quality of life, muscle strength and control, coordination, walking, and functional movement~     of children with cerebral palsy who are marginal ambulators. This is a randomized control~     trial with subjects randomly assigned to one of the 2 groups.Subjects in both groups will be~     seen twice a day for two weeks at our hospital for intervention and parent training, and then~     participate in a 10 week home-based program. During each subject's two-week clinic-based~     training, a parent or caregiver is trained in all home program exercises and/or equipment~     usage. This person must be able to safely perform the exercise program with the child. Each~     subject will also need to participate in three separate 5-hour long data collection sessions~     scheduled over the 4 month study period.~   "
235932|NCT00467402|"~     This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the~     prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients~     will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment.~     Patients demonstrating stable response at the end of the open-label treatment phase will be~     assigned to receive agomelatine or placebo for 52 weeks.~   "
235933|NCT00467389|"~     The purpose of this study is to determine the safety of intravenous cocaine in subjects~     receiving oral donepezil.~   "
235934|NCT00467376|"~     Primary:~        -  To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects~          with type 1 or type 2 diabetes mellitus.~        -  To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.~      Secondary:~        -  To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks~          12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with~          type 1 or type 2 diabetes mellitus~   "
235935|NCT00467363|"~     The primary objective of the study is to help elucidate the effects of low-dose aspirin in~     combination with folic acid on the incidence of live births and spontaneous abortions among a~     group of women who become pregnant compared to a control group.~   "
235936|NCT00467350|"~     The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better~     for treatment of fecal impaction in children who are constipated.~   "
235937|NCT00467337|"~     -  To assess the efficacy of medial-wedge insole in valgus knee osteoarthritis (OA).~        -  We hypothesized that medial-wedged insoles are biomechanically effective and should~          reduce lateral compartment loading in persons with valgus knee osteoarthritis with a~          consequent symptomatic improvement.~   "
235938|NCT00467324|"~     The objective of the study is to assess the effectiveness of the Aspire Medical Advance~     System in obstructive sleep apnea by demonstrating a statistically significant mean reduction~     in the apnea-hypopnea index (AHI) from baseline to 6 months, measured by polysomnography~     (PSG).~   "
235939|NCT00467311|"~     Hypothesis:~      Cystatin C compared with creatinine is a better and earlier marker of contrast-induced~     nephropathy in high and intermedium risk cardiac catheterization patients.~      Primary Objective:~      Establish if Cystatin C is superior detecting contrast-induced nephropathy than creatinine in~     high and intermedium risk cardiac catheterization patients.~   "
235940|NCT00467298|"~     The study is a randomized trial of a cardiopulmonary self-management intervention to improve~     functional capacity, health-related quality of life, and to reduce health care utilization.~     Two hundred (100 in each group) will be recruited from VA Puget Sound Health Care System over~     four years. Outcomes will be measured at three points: at entry, at the end of the 6 month~     intervention, and 12 months after entry. Change in functional capacity at the end of the~     intervention program is the primary outcome.~   "
235941|NCT00467285|"~     Subjects with diabetes and pre-diabetes are said to have increased bone loss when compared to~     the general population. Pioglitazone a thiazolidinedione, is a Food and Drug Administration~     (FDA) approved oral anti-diabetic agent for the treatment of type 2 diabetes. Though there~     are many benefits for using thiazolidinediones in the treatment of type 2 diabetes, there is~     data that indicates that rosiglitazone therapy results in a significant decrease in total~     body bone mineral density in mice. Whether it is true in humans is not clear. If the animal~     data can be extrapolated to humans, thiazolidinediones may pose a significant risk of adverse~     effects on bone. This study hypothesizes that treatment with the thiazolidinedione~     pioglitazone may result in significant reduction in bone mineral density. The aims of this~     are: 1. to evaluate the effect of pioglitazone on skeletal health; 2. to measure the bone~     mineral density (BMD) of the spine and hip, as well as bone turnover markers, at different~     times of persons taking thiazolidinediones and others not taking them; 3. to determine the~     change in BMD and bone turnover markers within different groups at different times; and 4. to~     compare these changes.~   "
235942|NCT00467272|"~     Primary Objective:~      -Evaluate the clinical efficacy and safety of Daptomycin given for treatment of~     catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the~     context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or~     without initial treatment with beta lactam antibiotics.~   "
235943|NCT00467259|"~     This study is designed to evaluate the endometrial safety of a testosterone patch as~     treatment for low libido in naturally postmenopausal women.~   "
235944|NCT00467246|"~     Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic~     Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity~     and mortality, prompt intervention and coma and close monitoring are essential. The study is~     designed to investigate whether a simple intervention with a long acting insulin can improve~     resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten~     hospital stay.~   "
235945|NCT00467233|"~     The objective of this study is to evaluate laser treatment and acid peel for the treatment of~     melasma.~   "
235946|NCT00467220|"~     The purpose of this study is to examine and compare the effects of alternate-day reductions~     in calorie intake or daily calorie restriction on the risk for cardiovascular disease and~     cancer.~   "
235947|NCT00467207|"~     The objective of this study is to gain more knowledge about the association between muscle~     weakness, spasticity and motor control in children with cerebral palsy, and its relationship~     to hand function.~   "
235948|NCT00467194|"~     RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab and sirolimus~     may also stop the growth of liver cancer by blocking blood flow to the tumor. Giving~     sirolimus together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of sirolimus when~     given together with bevacizumab in treating patients with liver cancer that cannot be removed~     by surgery.~   "
235949|NCT00467181|"~     The Primary objective is to reduce the incidence of postoperative renal dysfunction in a~     high-risk subset of patients undergoing cardiac surgery on cardiopulmonary bypass with~     Fenolopam, a selective dopamine-1 receptor agonist. Perioperative renal function will be~     observed in 3 randomly selected groups of patients-Fenoldopam infusion at 0.03 cg/kg/min,~     Fenoldopam at 0.1 mcg/kg/min or placebo~      Secondary objective: will be to correlate Fenoldopam usage with postoperative clinical~     outcomes such as ICU stay, hospital stay, need for inotropes/vasopressors, need for~     diuretics, requirements for ECF at discharge, and overall perioperative cost reduction~     through decreased ICU and hospital length of stay.~   "
235950|NCT00467168|"~     Cardiovascular complications are the leading cause of death among type 2 diabetic patients.~     Postprandial triglyceride-rich lipoproteins (ppTRLs) are atherogenic. Dietary fatty acid~     quality, that is, dietary fatty acid composition is related to atherogenesis. However, to~     date, the overall influence of dietary fatty acid compositions on lipids in different~     subfractions of ppTRLs still remains unknown among Chinese diabetic patients. This paucity of~     evidence may limit the establishment of optimal recommendation of dietary fatty acid~     composition for type 2 diabetes. We have 2 hypotheses:~        1. Different dietary fatty acid compositions lead to differential overall responses of~          lipids in four subfractions of ppTRLs over postprandial 6 h.~        2. One dietary fatty acid composition will be identified as anti-atherogenesis for future~          study as it can improve atherogenic ppTRLs.~   "
235951|NCT00467155|"~     The purpose of this study is to examine Helicobacter pylori bacteria in the stomach fluids of~     children who are hospitalized and receiving nutritional care via nasogastric feeding (tube~     from the nose to the stomach) to treat malnutrition. The H. pylori strains from Gambian~     children may differ genetically from the strains found in the stomachs of adults from the~     same community. The fluid samples will be examined for H. pylori bacterial infections that~     may make children sick and unable to absorb food. Ninety hospitalized Gambian children, less~     than 2 years of age, requiring a nasogastric feeding tube will have stomach fluid samples~     taken via the gastric tube. Thirty mothers of children who are positive for H. pylori~     bacteria will provide a sample of stomach fluid. This study may help develop treatments to~     heal the stomach and improve child growth. This study will be conducted at the Medical~     Research Council of Great Britain Research Laboratories and Clinical Facility in Fajara.~   "
235952|NCT00467142|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     bevacizumab together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with~     combination chemotherapy works as first-line therapy in treating patients with metastatic~     colorectal cancer that cannot be removed by surgery.~   "
235953|NCT00467129|"~     RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with~     cancer may help doctors learn more about changes that occur in DNA and help doctors~     understand how patients respond to treatment.~      PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with~     metastatic colorectal cancer.~   "
235954|NCT00467116|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find~     tumor cells and help kill them or carry tumor-killing substances to them. Others interfere~     with the ability of tumor cells to grow and spread. Cetuximab may also stop the growth of~     tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to~     kill tumor cells. Gemcitabine and cetuximab may make tumor cells more sensitive to radiation~     therapy. Giving gemcitabine together with cetuximab and radiation therapy may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when~     given together with cetuximab and radiation therapy in treating patients with locally~     advanced pancreatic cancer that cannot be removed by surgery.~   "
235955|NCT00467103|"~     The purpose of this research is to utilize functional magnetic resonance imaging (fMRI) to~     investigate brain reorganization for language behavior in stroke patients with aphasia. A~     primary focus of the study is on recovery of nonfluent propositional speech and naming in~     chronic aphasia patients. The fMRI technique is used to examine activation in the left~     hemisphere (LH) and right hemisphere (RH), during recovery of specific language behaviors in~     chronic nonfluent aphasia patients.~   "
235993|NCT00466609|"~     This will be a controlled, randomized, double-blind and double-dummy study on the treatment~     augmentation strategy for obsessive compulsive disorder patients non-respondent to first line~     pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum~     dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the~     association of fluoxetine with clomipramine.~   "
236008|NCT00466401|"~     The aim of our study is to Estimate the reduction of LDL by ezetimibe in hypercholesterolemic~     patients on simvastatin.Investigate the effect of LDL lowering by ezetimibe on platelet~     activity and LDL tendency to peroxidation in hypercholesterolemic patients on simvastatin~     therapy~      The hypothesis is that:~        1. LDL lowering by ezetimibe on-top of simvastatin in patients on fixed dose of simvastatin~          can reduce platelet aggregation, due to the potential decreasing of cholesterol content~          in the platelet membranes.~        2. LDL lowering by ezetimibe can lower LDL tendency to peroxidation.~   "
235956|NCT00467090|"~     This study will identify symptoms and other characteristics of Parkinson s disease that may~     be associated with changes in a gene called leucine-rich repeat kinase 2 (LRRK2). Changes in~     this gene have been found in patients with and without a family history of Parkinson s~     disease. This study will examine people with Parkinson s disease to try to identify how~     symptoms develop over time. First-degree relatives of patients will also be studied.~      People 18 years of age or older with Parkinson s disease or people who have a first-degree~     relative with Parkinson s disease may be eligible for this study.~      Participants visit the NIH Clinical Center every other year for 10 years for some or all of~     the procedures listed below. Each visit requires 3-4 days of testing, which may be done on an~     inpatient or outpatient basis. Telephone interviews are conducted during the alternate years.~        -  History and physical examination.~        -  Smell testing: Subjects are asked to identify 40 different scents.~        -  Sensory testing: Objects with grooves and ridges are touched to subjects fingertips.~          With their eyes closed, the subjects are asked to say which way the grooves and ridges~          run on the objects.~        -  Neuropsychological evaluation: Subjects are asked about their memory and thinking and~          may be asked to complete some pen and paper tests.~        -  Psychiatric evaluation: Subjects are asked about psychiatric symptoms, including anxiety~          and depression.~        -  Blood drawing: Blood is drawn through a needle in the arm.~        -  Magnetic imaging resonance (MRI) scans of the brain: MRI uses a strong magnetic field~          and radio waves to obtain images of body organs and tissues. During the test, subjects~          lie on a table that can slide in and out of the MRI scanner (a metal cylinder surrounded~          by a strong magnetic field). The procedure lasts about 30 minutes, during which the~          subjects may be asked to lie still for up to 5 minutes at a time.~        -  Transcranial sonography (TCS): TCS uses sound waves to obtain images of the brain.~          Subjects lie on their back and an ultrasound device is moved around the scalp.~        -  Sleep study (1-2 night hospital admission): Subjects brain waves are recorded during~          sleep using electroencephalography (EEG). Their breathing rate, pulse and oxygen level~          are also monitored.~        -  Questionnaire: Subjects complete several questionnaires designed to obtain information~          on symptoms or traits that have been reported to be associated with Parkinson s disease.~   "
235957|NCT00467077|"~     RATIONALE: Gefitinib may stop the growth of kidney cancer by blocking blood flow to the tumor~     and by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2b may~     interfere with the growth of tumor cells and slow the growth of kidney cancer. Giving~     gefitinib together with PEG-interferon alfa-2b may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gefitinib together with~     PEG-interferon alfa-2b works in treating patients with unresectable or metastatic kidney~     cancer.~   "
235958|NCT00467064|"~     We will develop brief versions of the classic 6-week Arthritis Self-Management Program and~     evaluate their effectiveness.~   "
235959|NCT00467051|"~     This phase II trial is studying how well giving combination chemotherapy works in treating~     young patients with recurrent or resistant malignant germ cell tumors. Drugs used in~     chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving more than one drug (combination chemotherapy) may kill more tumor cells.~   "
235960|NCT00467038|"~     This study examines the effects of 12 months of dialectical behavior therapy (DBT) for~     subjects with borderline personality disorder on aggression, anger and emotional~     dysregulation. Treatment effects will be measured by changes in interview, self-report,~     psychophysiology testing and fMRI neuroimaging.~   "
235961|NCT00467025|"~     This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to~     estimate the improvement in progression free survival (PFS) and evaluate the safety and~     tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with~     advanced clear cell carcinoma of the kidney.~   "
235962|NCT00467012|"~     To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are~     administered concomitantly to patients with metastatic breast cancer.~   "
235963|NCT00466999|"~     In this study, we will compare the safety and efficacy of 400 mcg sublingually administered~     misoprostol alone to standard surgical care for the treatment of incomplete abortion. This~     study will provide important data on the role of misoprostol in health services offering an~     array of treatments for incomplete abortion. Women could significantly benefit from a~     non-invasive treatment option for incomplete abortion. While safe surgical services are~     becoming more widespread, there is still a serious risk of complications from these~     procedures. Especially in developing countries, infection, hemorrhage and uterine damage are~     still too common. Medical treatment of incomplete abortion using misoprostol would be a~     tremendous step to reducing morbidity and mortality due to abortion complications.~   "
235964|NCT00466986|"~     The purpose of this study is to determine if the combination of Abraxane and Carboplatin~     together will improve the chances of controlling recurrent ovarian/fallopian tube/peritoneal~     cancer.~   "
235965|NCT00466973|"~     Atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to~     prevent risk of stroke and long term poor outcomes. At the same time one have heart surgery,~     a small additional procedure can be done to treat atrial fibrillation. Surgeons have a choice~     of six different devices that he or she can use to treat your atrial fibrillation. It is not~     known at this point which device is best at treating you, as each device seems to have the~     same success rate at curing atrial fibrillation. One of the six devices will be selected~     randomly by card pulled out at the time of enrollment. It is therefore the purpose of this~     study to compare the devices to each other and to follow up after surgery to determine if any~     one device is best. This information will be valuable to surgeons and to patients as the~     treatment for atrial fibrillation develops in the future.~   "
235966|NCT00466960|"~     RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the~     immune system in different ways and stop tumor cells from growing and may also increase the~     number of immune cells found in bone marrow or peripheral blood and help the immune system~     recover from the side effects of chemotherapy. Drugs used in chemotherapy, such as paclitaxel~     albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving GM-CSF~     together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective~     treatment for ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.~      PURPOSE: This phase II trial is studying how well giving GM-CSF together with paclitaxel~     albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian~     cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to previous~     chemotherapy~   "
235967|NCT00466947|"~     This is a study in a large number of healthy children less than 3 years old to measure the~     efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate~     vaccine (Synflorix vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection)~     likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of~     otitis media (ear infection) in children under 3 years old.~   "
236343|NCT00461903|"~     The purpose of this 7- to 13-month study is to determine the efficacy of 8 mg/day oral~     perindopril to prevent the recurrence of atrial fibrillation (AF) in patients with essential~     hypertension.~   "
235968|NCT00466934|"~     This study will test a method of measuring brain blood flow called near infrared spectroscopy~     (NIRS). It will determine whether NIRS gives the same results as the more commonly used~     technique, functional magnetic resonance imaging (fMRI).~      Healthy normal volunteers between 18 and 60 years of age may be eligible for this study.~     Participants come to the NIH up to six times for experiments using NIRS and fMRI. They do the~     following tasks while they are undergoing NIRS or fMRI:~        -  looking at a computer monitor while a checkerboard pattern changes~        -  wiggling the toes and moving the fingers~        -  Reading words on a computer screen and pushing one button if they are plants and another~          if they are animals.~      For NIRS, a frame is placed on the head and held it in place with a metal band. The frame~     holds sensors that contact the scalp.~      For fMRI, the subject lies on a table that can slide in and out of an MRI scanner, a metal~     cylinder surrounded by a strong magnetic field. fMRI uses a strong magnetic field and radio~     waves to obtain images of the brain while the subject performs tasks. During the procedure,~     The subject wears earplugs to muffle the sound of loud knocking noises that occur during~     scanning.~   "
235969|NCT00466921|"~     RATIONALE: Lenalidomide may stop the growth of mycosis fungoides/Sezary syndrome by blocking~     blood flow to the cancer.~      PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients~     with relapsed mycosis fungoides/Sezary syndrome.~   "
235970|NCT00466908|"~     The purpose of this study is to determine the accuracy of the Pentacam and IOL Master to~     calculate the effective corneal power (keratometry, corneal curvature) in patients who have~     undergone both corneal refractive surgery and lens extraction with intraocular lens~     implantation.~   "
235971|NCT00466895|"~     Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.~   "
235972|NCT00466882|"~     The purpose of this study is to assess the use of this Lap-Band system for the purpose of~     promoting weight loss in renal failure patients who do not qualify as transplant candidates~     because of excessive BMI's~   "
235973|NCT00466869|"~     This is a randomized, double-blind, placebo-controlled, two-to three center study. The study~     will consist of 2 treatment groups (Betahistine 48 mg/day or matching placebo). Approximately~     30 subjects (15 per treatment group) will be randomized into this 6-week study.~      A single blinded placebo treated period of up to 14 days will be used to determine subjects~     suitability for inclusion in the trial.~      In order that a patient will be defined as valid for inclusion in the study, patients should~     be able to present consistent LDL-C values, taken prior to randomization (at screening visit~     1 and screening visit 2), without deviation of more than 12% of each value from their mean.~      Within one week from the second screening visit, subjects who meet all inclusion criteria and~     none of the exclusion criteria will be randomly assigned to 1 of the following treatment~     groups:~        -  Betahistine 24 mg BID (48 mg/day total), or~        -  Matching placebo BID.~      Double-blind treatment will continue for 4 weeks. Study medication (betahistine and/or~     matching placebo) will be administered BID (before lunch and before dinner).~      During the study, subjects will undergo dietary assessment.~      The primary efficacy parameter is change in LDL-C from baseline (randomization) to Week 4 and~     the percentage of patients that reduce their LDL-C by 10% or more.~   "
235974|NCT00466856|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase II trial is studying how well internal radiation therapy works in~     treating patients with liver metastases from neuroendocrine tumors.~   "
235975|NCT00466843|"~     Myelodysplastic syndrome (MDS) is a rare, potentially serious bone marrow disease. Currently~     available treatments for MDS have been only somewhat beneficial. The purpose of this study is~     to determine the effects of the medication antithymocyte globulin (ATG) in adults with MDS~     and to determine which individuals with MDS are most likely to benefit from treatment with~     ATG.~   "
235976|NCT00466830|"~     RATIONALE: Certain psychological and social factors may increase the risk of developing~     chronic pain after surgery. Evaluating these factors over time in patients who have undergone~     surgery for breast cancer may help doctors plan treatment and improve patients' quality of~     life.~      PURPOSE: This clinical trial is studying the psychological and social factors that may~     increase the risk of developing chronic pain after surgery in women with breast cancer .~   "
235977|NCT00466817|"~     Cytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The~     purpose of this study is to compare a 6-week course to a 6-month course of the drug~     valganciclovir in babies born with CMV to assess the safety and efficacy of this treatment.~     Participants will include 104 infants (30 days old or younger) born with CMV disease. All~     infants will take valganciclovir by mouth for 6 weeks. At the end of the 6 week period,~     subjects will be assigned by chance to receive either valganciclovir or placebo (inactive~     substance) to complete the 6 months of antiviral treatment. Patients will be followed for the~     study related evaluations of safety, changes to hearing, and developmental milestones for up~     to 2 years. Patients will be followed by telephone contact for an additional 3 years. Thus,~     participants may be involved in study related procedures for approximately 5 years.~   "
235978|NCT00466804|"~     Injury of transplant tissue by a transplant recipient's immune system continues to be the~     leading cause of graft rejection and recipient death. The purpose of this study is to~     identify a single test or a combination of noninvasive tests currently used for heart~     transplant monitoring that correlate to long-term graft survival.~   "
235979|NCT00466791|"~     Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD~   "
235980|NCT00466778|"~     This is a case-controlled study using an innovative, non-invasive, FDA approved technology to~     measure the autonomic nervous system. Detection of unsuspected DPN or ANS dysfunction may~     allow physicians to re-assess current treatment and develop new dietary or pharmacological~     strategies. This also is an immense public health concern since there are currently 18~     million diabetics in the United States and 220 million worldwide.~   "
235981|NCT00466765|"~     The primary objectives of this study is to determine whether use of a negative pressure~     external soft-tissue expansion system pre-operatively and post-operatively improves and~     secures graft survival in autologous fat micro grafting breast augmentation and~     reconstruction procedures.~   "
237150|NCT00451152|"~     The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering~     efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle~     glaucoma.~   "
235983|NCT00466739|"~     In both symptomatic and asymptomatic disease, only about half of medicines are taken as~     prescribed1. Relatively little is known about how patients with Parkinson's disease take~     their medication. One of the challenges in the management of Parkinson's disease is the~     prevention and treatment of involuntary movements2,3 and wild fluctuations between being~     mobile and able to function against being slow, stiff and unable to move which recurs as a~     delayed (several years) effect of taking antiparkinson medication. One theory of why this~     occurs is that it is due to pulsatile rather than continuous delivery of medication to the~     brain4. If patients take their medicines erratically and irregularly, this causes more~     fluctuations in blood and therefore brain drug levels may prime patients for complications in~     the future. This project will define the extent of irregular medication taking in Parkinson's~     disease, examine associated clinical and demographic characteristics and examine the ease of~     adherence to different drug regimes. Knowledge of therapy adherence will help support~     patients in using their medicines to best effect. In the present document the terms~     compliance and adherence are used with equal meaning.~   "
235984|NCT00466726|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of~     immune cells found in bone marrow or peripheral blood. Giving booster vaccinations may make a~     stronger immune response and prevent or delay the recurrence of cancer.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients~     with Philadelphia chromosome-positive chronic myelogenous leukemia.~   "
235985|NCT00466713|"~     This study will investigate the effects of rosiglitazone, a medicine commonly used to treat~     type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure~     which is not due to heart attacks. The primary purpose of the study is to determine whether~     treatment with an insulin-sensitizing medication will improve the heart's ability to~     metabolize glucose (sugar).~   "
235986|NCT00466700|"~     H. pylori infection causes the stomach to become inflamed. The problem usually begins in~     childhood and leads to stomach problems in adult life. Study participants will be residents~     of The Gambia, West Africa, and will be studied at the Medical Research Council of Great~     Britain facility in Fajara, The Gambia. Up to 75 adults 18 years and older and 20~     malnourished children 6 months to 2 years of age, who are undergoing endoscopy as part of~     their medical care, will be studied. (Endoscopy is when a thin, lighted device is used to~     look inside the body.) During this study procedure, tiny pieces of tissue, called biopsies,~     will be taken from the stomach and checked for H. pylori infection. Participants found to be~     infected will be given antibiotic treatment. Participation in the study will last~     approximately 72 hours.~   "
235987|NCT00466687|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with~     bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab~     works in treating patients with stage IV melanoma.~   "
235988|NCT00466674|"~     Donor mobilization :~      Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days.~      Hematopoïetic Stem Cell Harvest:~      By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ >=~     2 and <= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient~     graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG~        -  D-5 : Fludarabine (30 mg/m²)~        -  D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)~        -  D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)~        -  D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg)~        -  D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at~          3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with~          an anti A/B antibodies titer> 1/32.~      Transplant : HSC at D0~      • 3 months after Transplantation :~      Disease Evaluation :~        -  If CR : Supervision. Then if progression: 4 cycles of Bortezomib.~        -  If no CR : Bortezomib (4 cycles)~           • Evaluation after Bortezomib cycles~        -  If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI~   "
235989|NCT00466661|"~     To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of~     acamprosate in individuals with alcohol dependence and bipolar disorder who are also~     receiving mood stabilizing medication. The study will assess the safety and efficacy of~     acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use~     and mood symptoms relative to placebo.~      The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and~     alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement~     in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary~     hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with~     acamprosate will have greater mood stability as compared to those treated with mood~     stabilizers alone.~   "
235990|NCT00466648|"~     This study wishes to compare patient satisfaction and cosmesis of two different closure~     methods of laparoscopic ports. One method uses tissue adhesive (Dermabond) with a deep~     sub-cutaneous stitch and a Band-Aid dressing. The comparison method uses a 3.o undyed vicryl~     transcutaneous stitch, with a Bacitracin and Tegaderm dressing.~   "
235991|NCT00466635|"~     Approximately 65 patients will be entered into this study taking place in North America. The~     aim of this study is to evaluate the safety, efficacy and absorption of an investigational~     drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is~     provided including doctor visits, physical exams, laboratory tests and study medication.~     Total length of participation is 6 weeks.~   "
235992|NCT00466622|"~     FlowMet study is a sub-study of the PregMet study (registered in 2005).~      The aim of the FlowMet study is to register the possible effect of metformin on the blood~     flow of the uterine artery in pregnant PCOS women. The participants will be examined with~     ultrasound Doppler in gestational week 10-13:~        1. before and 3h after the first tablet intake of metformin/placebo~        2. and 10-14 days after inclusion in the trial~        3. blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.~   "
235994|NCT00466596|"~     Twenty, house dust mite (HDM)-allergic non-smoking subjects with or without mild asthma~     between the ages 18-50 will be recruited. The primary endpoint will be nasal eosinophilia.~     Each volunteer will be screened with skin testing, pulmonary function testing and induced~     sputum. If eligible they will return for baseline nasal allergen challenge and lavage.~     Approximately two weeks later they will return for gamma tocopherol (gT) dosing visit. After~     completing 14 days of daily high dose (1200mg) gT, they will return for a second nasal~     allergen challenge. This visit will also include pulmonary function testing and blood draw.~     The purpose of this study is to determine if high dose gamma tocopherol therapy can reduce~     allergen induced nasal inflammation.~   "
235995|NCT00466583|"~     This is a Phase 1, open-label, non-randomized, dose-escalation study to determine the maximum~     tolerated dose (MTD), safety, tolerance, and pharmacologic profile of EZN-2968, a locked~     nucleic acid antisense oligonucleotide against hypoxia-inducible factor 1α administered as a~     2-hour intravenous (i.v.) infusion weekly for 3 weeks per 6-week cycle. In patients treated~     at a recommended Phase 2 dose of EZN-2968, dose intensification will proceed by maintaining~     the dose, but gradually increasing the number of doses per 6-week cycle. Up to 3~     intensification cohorts will receive the recommended Phase 2 dose of EZN-2968.~   "
235996|NCT00466570|"~     Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the~     risk of infection. Previous studies have suggested that antibiotics containing a preservative~     (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). The purpose~     of this research is to compare how quickly to the two commonly prescribed antibiotics~     eliminate bacteria from the eye surface.~   "
235997|NCT00466557|"~     The purpose of this study is to find new ways to control malaria by looking at mosquitoes~     infected with the disease. Knowledge of the genetics that affect the spread of malaria by~     mosquitoes will help in developing control strategies. A small amount of blood from infected~     humans will be used to infect the mosquitoes. No contact will occur between the human subject~     and the mosquito. Study participants will be divided into 2 groups of 20, for a total of 40~     children, ages 5-10, in Burkina Faso, West Africa. Each subject will be screened by~     finger-prick once per month, from June through October, until they reach a maximum age of 10.~     Two positive subjects of the 40 screened will be asked to donate about 1 teaspoon of blood,~     which will be used to feed and infect the mosquitoes. Study participants will be involved in~     study related procedures for a maximum of 5 years.~   "
235998|NCT00466544|"~     Study objective is to provide prospective randomized controlled data on pediatric pain levels~     found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.~   "
235999|NCT00466531|"~     RATIONALE: Using T cells from the patient that have been treated in the laboratory may help~     the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy,~     such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. Giving laboratory-treated T cells~     together with cyclophosphamide may kill more cancer cells.~      PURPOSE: This is a two-stage protocol, consisting of a single-institution phase I safety~     study and multi-institution phase IIa extension study.~   "
236000|NCT00466518|"~     This study is designed to look at the effect sitagliptin has on tacrolimus and sirolimus drug~     levels in kidney transplant patients. It is also designed to look at the side effects~     experienced in the transplant population.~   "
236001|NCT00466505|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth~     of colorectal cancer by blocking blood flow to the tumor. Celecoxib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Giving cetuximab together~     with celecoxib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with celecoxib~     works in treating patients with metastatic colorectal cancer or colorectal cancer that cannot~     be removed by surgery.~   "
236002|NCT00466492|"~     The purpose of the study is to determine whether sedation of the critical ill patient~     prolongs the time receiving mechanical ventilation.~   "
236003|NCT00466479|"~     This study is evaluating possible non-intraocular pressure (IOP) related effects of the~     alpha-1 agonist brimonidine in human subjects affected by a progressive glaucomatous optic~     neuropathy. Brimonidine was proven as neuroprotective in several pre-clinical animal studies.~   "
236004|NCT00466466|"~     This study aims to establish a tolerable dose level and regimen of RAD001 in combination with~     cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage~     small-cell lung cancer (SCLC) who have not previously been treated with systemic~     chemotherapy.~   "
236005|NCT00466453|"~     The purpose of this study is to compare an adaptive Web-based learning system to a~     non-adaptive system for teaching physicians-in-training about ambulatory medicine.~   "
236006|NCT00466440|"~     The purpose of the study is to compare the response rates for prostate cancer patients taking~     chemotherapy plus enzastaurin versus chemotherapy plus placebo.~   "
236007|NCT00466414|"~     It has been shown through research that alveolar ridges (Part of jaw bone holding teeth) tend~     to lose width and height after extraction of teeth. Lost in height and width of the ridge can~     cause problems in the restoration of missing teeth with bridges and implants. Hence, this~     study is proposed to assess the use of polycaprolactone (PCL) scaffolds for alveolar ridge~     preservation following extraction of teeth in humans.~      20 patients will be divided into 2 groups. In one group, patients will have a PCL scaffold~     placed into the socket after extraction. In other group, no scaffold will be placed. After a~     healing period of 6 months, changes in width and height from baseline is measured for both~     groups. A bone biopsy is also taken at this time from both groups. Hardness of bone,~     histologic (microscopic) features of cells, percentage of living bone, radiographic density~     of alveolar ridge and mechanical properties of the bone biopsy are then assessed.~      This study will attempt to show that a resorbable (can be removed by body) material like a~     PCL scaffold can be used to maintain physical dimensions of the alveolar ridge after~     extraction and will not interfere with osseointegration (fusion with bone). It will avoid the~     necessity for additional corrective surgeries for patients when alveolar ridges presented~     with inadequate width and height for placement of aesthetically pleasing and functionally~     sound restorations. This would improve chances of success for the patient.~      If the study successfully shows that the PCL scaffold can be accepted by the body with good~     bone growth, uses for the PCL scaffold can be extended to other areas of clinical medicine~     and dentistry.~      The PCL scaffold to be used in this study is designed and developed by a local company~     (Osteopore International Pte Ltd). With the success of this product, Singapore's standing as~     a biomedical hub will be further enhanced.~   "
236510|NCT00459706|"~     The purpose of this study is to explore and compare the perceptions and satisfaction for two~     different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept~     Prefilled Syringe) in patients with rheumatoid arthritis (RA).~   "
236009|NCT00466375|"~     The purpose of this study is to determine if there are genes that are common in children with~     infantile hemangioma. This information will allow physicians to improve care for patients who~     have been diagnosed with this disease and to provide their parents with more complete~     information regarding the cause of this disease. This research is being done because many~     unanswered questions remain regarding children with infantile hemangioma. There are very few~     medications to treat infants with hemangiomas.~   "
236010|NCT00466362|"~     There are evidence from numerous studies on effect of lifestyle intervention in morbidly~     obese patients with type 2 diabetes. This study examines the effect of the Evje-model on~     type 2 diabetes.~      The Evje-model is a combined 12 months model, consisting of repeated stays in a specialist~     centre, telephone follow-up at home, home groups, self monitoring and close contact with the~     patients’ local physician.~   "
236011|NCT00466349|"~     This is a registry of individuals affected by Spinal Muscular Atrophy (SMA) and/or family~     members of individuals affected by SMA. The purpose of the registry is to allow researchers~     studying the biological basis of SMA and potential therapies in SMA access to individuals~     interested in participating in research and/or experimental therapies. The International SMA~     Patient Registry is supported by CureSMA.~   "
236012|NCT00466336|"~     The purpose of our prospective study was to evaluate the value of Doppler parameters and~     compare the diagnostic accuracy of Doppler parameters with various biochemical indices in~     predicting significant hepatic fibrosis (≥ F2) and cirrhosis (F4) in chronic hepatitis C~     (CHC) patients.~   "
236013|NCT00466323|"~     The purpose of this study is to learn how to help veterans play a stronger role in shaping~     their mental health care. Specifically we want to see if we can help veterans improve their~     mental health treatment by helping them decide if they want to involve family in their mental~     health treatment, and if so, how. The study will compare a family member provider program~     to an enhanced treatment as usual approach in achieving these goals.~   "
236014|NCT00466310|"~     We plan to use a metabolomics lipid platform to map biochemical signatures in unmedicated~     schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug~     aripiprazole and compare that to lipid perturbations induced by risperidone. These drugs have~     inherently different risk for metabolic adverse effects and patients respond to them~     differently. Metabolic signatures for the drugs capture significant biochemical information~     that could explain part of the basis for varied drug response within individuals and will~     highlight pathways implicated in drug action and in disease pathogenesis possibly enabling~     new drug design strategies. In addition, we will compare patients to healthy controls at~     baseline in regard lipid profiles.~   "
236015|NCT00466297|"~     Collaborative practice may improve patient outcomes in specific disease conditions and health~     care settings. The SCRIPT Programme is an intervention to implement informal, but structured,~     communication etiquette between members of interprofessional ward-based clinical teaching~     units (CTUs) in General Internal Medicine (GIM) hospital divisions.~   "
236016|NCT00466284|"~     A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients~     will be treated.~      STUDY OBJECTIVES~      Primary: Objective response rate~      Secondary: Progression free survival, Overall survival and Safety of Tarceva~   "
236017|NCT00466271|"~     The purpose of the study is to validate the diagnostic accuracy and reproducibility of SAPI~     to predict significant hepatic fibrosis in HCV patients with PNALT who are scheduled to~     receive combination therapy with pegylated interferon plus ribavirin and percutaneous liver~     biopsies.~   "
236018|NCT00466258|"~     Main objective:~        -  To evaluate the applicability of the treatment:~             1. To evaluate the treatment toxicity according to the Common Terminology Criteria~               (CTC) version 3.0 of the National Cancer Institute (NCI).~             2. To evaluate opportunistic and non-opportunistic infections after 6 cycles of~               treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and~               prednisone (R-CHOP) administered every 14 days and highly active antiretroviral~               therapy (HAART) in patients with diffuse large B cell lymphoma (DLBCL) and HIV~               infection.~             3. To evaluate the adherence to the treatment with 6 cycles of R-CHOP considering the~               delays in the administration of the cycles and the reductions in the doses of~               chemotherapy (planned dose administered in predicted term).~      Secondary objectives:~        -  To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection after~          6 cycles of treatment with R-CHOP administered every 14 days (R-CHOP/14):~             1. To determine the global response and complete remission tax.~             2. To evaluate the duration of the response.~             3. To evaluate the probability of event-free survival in 5 years.~             4. To evaluate the probability of global survival in 5 years.~        -  To identify predictive factors of response after 6 cycles of treatment with R-CHOP~          administered every 14 days in patients with DLBCL and HIV infection.~        -  To evaluate the impact of the therapeutic combination of R-CHOP and HAART in the~          parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count).~   "
236019|NCT00466245|"~     A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine-~     naive subjects at three dose levels.~   "
236020|NCT00466232|"~     The primary objective of this study is to determine the maximum tolerated dose of sorafenib~     up to the full active dose when combined with standard weekly dosing of topotecan in patients~     with recurrent small cell lung cancer and to characterize the toxicities associated with the~     combination of topotecan and sorafenib in this patient population~   "
236021|NCT00466219|"~     The aim of the study is to assess whether patients with recurrent hepatitis C after liver~     transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment~     for 48 weeks.~   "
236062|NCT00465673|"~     Primary objective:~      To determine the brain response rate of Lipo-Dox in breast cancer patients with brain~     metastasis~      Secondary objectives:~        1. To determine the overall objective response rate (ORR)~        2. To determine the progression free survival, and duration of objective response~        3. To evaluate the overall survival (OS)~        4. To assess the safety profiles~   "
236282|NCT00462748|"~     To evaluate the percentage of patients with either established cardiovascular disease (CVD),~     at high risk of developing CVD or with diabetes who are on simvastatin 40mg, with fasting~     LDL-C > 2mmol/l, who are able to attain the recommended LDL-C target of < 2mmol/l following 6~     weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin~     10mg.~   "
236022|NCT00466206|"~     This is a medical research study.~      The study investigators have developed a method to gradually repair pectus excavatum (sunken~     chest) deformity by placing a magnet on the sternum (breastbone) and then applying an~     external magnetic force that will pull the sternum outward gradually.~      Potential candidates for this study are children and adolescents with a previously diagnosed~     congenital pectus excavatum (sunken chest) deformity who are otherwise healthy and are~     seeking corrective surgery for their condition. They will be residents of the U.S. and~     between the ages of 8 and 14 years of age. Potential candidates and their families will have~     already been counseled about this condition and about the standard way to repair this~     deformity.~      The purpose of this study is to test what effects, good and/or bad, placing an~     external/internal magnetic device has on correcting pectus excavatum deformity in children,~     and the safety of using such a device for treatment.~   "
236023|NCT00466193|"~     The purpose of the study is to evaluate sleep onset following administration of zolpidem~     tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.~   "
236024|NCT00466180|"~     Taking antiretrovirals once-a-day is considered the simpler way to improve adherence.~     However, it is not know if this assertion apply to patients taking their medication~     twice-a-day who change to once-a-day.~      We hypothesized that once-daily dosing improves adherence.~   "
236025|NCT00466167|"~     The general aim of this trial is to determine the efficacy (as measured by the change from~     baseline to the end of the maintenance phase in the total score for Unified Parkinsons~     Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER,~     in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in~     Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with~     advanced Parkinsons Disease and motor fluctuations.~      In addition, a numerical comparison of the efficacy of pramipexole extended release versus~     pramipexole immediate release will be done.~      The efficacy of pramipexole immediate release will also be compared to placebo, for assay~     sensitivity.~   "
236026|NCT00466154|"~     Aspirin resistance is the persistent platelet activation, demonstrated by platelet function~     tests (1).~      The hypothesis is that:LDL lowering by statin in patients with aspirin resistance can improve~     the effect of aspirin due to the potential decreasing of cholesterol content in the platelet~     membranes.~      Patients and methods:Forty hypercholesterolemic patients with aspirin resistance after 5 days~     of treatment with aspirin and high LDL and triglycerides<300 mg/dL, will be enrolled.~      Ten healthy volunteers will be the control group.~   "
236027|NCT00466141|"~     This study will focus on maintenance of weight loss achieved in the 2007 Shape-Up Rhode~     Island(SURI)program. We plan to recruit 180 individuals who participated in SURI and lost at~     least 10 pounds to take part in a 4-month weight loss maintenance program when the SURI ends.~     Participants will be randomly assigned to one of three groups: Education, Increased Exercise,~     or Daily Self-Weighing.~   "
236028|NCT00466128|"~     The purpose of this study is to determine if the short term use of indomethacin will reduce~     the number of women delivering within 48 hours when given to women with preterm premature~     rupture of membranes (PPROM) between 24- 32 weeks of gestation. We hypothesize that~     indomethacin's anti-inflammatory and tocolytic action will reduce the number of women~     delivering within 48 hours when given to women with PPROM between 24-32 weeks of gestation.~   "
236029|NCT00466102|"~     The purpose of this study is to determine wether RAD001 can inhibit growth of tumour cells~     and/or stop the formation and activity of bone degrading osteoclasts.~   "
236030|NCT00466089|"~     A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and~     erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung~     cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile,~     and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D~     Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.~   "
236031|NCT00466076|"~     The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as~     preventive therapy of the immunomodulatory substance named copaxone which had been proven as~     safe and effective agent for a neurodegenerative disease, in arresting the progression as~     well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent~     copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may~     open a new avenue of preventive treatment for the disease which is the major cause of legal~     blindness in the industrial world~   "
236032|NCT00466063|"~     This registry will evaluate long-term safety and efficacy of deferasirox in children with~     transfusional iron overload.~   "
236033|NCT00466050|"~     Thirty patients scheduled to coronary angiography and IVUS in according to their treating~     physician decision will be enrolled in the study. The coronary angiography and IVUS will be~     done on according to regular clinical standards.~      As the study protocol, 40 cc of blood will be drawn from the patients after written informed~     consent.~      The laboratory tests will be processed for the above mentioned serum markers of unstable~     plaque.~      A multivariate correlation test will be done between the different serum markers and the~     plaque morphology by angiography and composition (virtual histology) by IVUS.~   "
236034|NCT00466037|"~     Rituximab is a genetically engineered chimeric anti-CD20 monoclonal antibody that selectively~     targets CD20+ B cells and induces a transient depletion of the CD20+ mature B cell~     subpopulation.The objective of our study was to assess the effect of rituximab on the~     efficacy and safety of influenza virus vaccine in patients with rheumatoid arthritis (RA).~   "
236035|NCT00466024|"~     The purpose of this study is to conduct a randomized controlled trial of the efficacy of a~     combination of HEPA room air cleaners plus an ETS reduction behavior training as compared to~     either HEPA air cleaners plus standard asthma education or delayed HEPA air cleaners and~     standard asthma education (control group).~   "
236074|NCT00465517|"~     The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone -~     on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic~     medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females~     with catamenial epilepsy.~      Catamenial epilepsy refers to a relationship between seizure frequency and a woman's~     menstrual cycle, where the number of seizures increases around the time of a woman's~     menstrual cycle.~   "
236036|NCT00466011|"~     Introduction: The full night polysomnography (PSG) in sleep lab is the gold standard to~     Obstructive Sleep Apnea (OSA) diagnosis. However, there is a need to evaluate simple and~     accurate home diagnostic equipment that can reliably detect or exclude OSA. The aim of our~     study was to evaluate if an ambulatory portable monitor (SD) is accurate to measure~     apnea-hypopnea index (AHI) in OSA patients referred to a Sleep Lab. Methods: Patients with~     clinical suspicion of OSA were selected. Three-order randomized evaluations had been~     performed within a period of two weeks: the 1) SD (Stardust®, Respironics, Inc, USA) was used~     at patients home (SD home), 2) SD was used simultaneously with PSG in the sleep lab (SD+PSG~     lab) and 3) PSG was performed without the use of SD (PSG lab). Four AHI were generated and~     analyzed: AHI from SD home, AHI from SD of SD+PSG lab, AHI from PSG of PSG+SD lab and AHI~     from PSG lab. The analyses of SDs and PSGs recordings were performed by two blinded~     technicians.~   "
236037|NCT00465998|"~     The aim of the study was to evaluate any possible associations between engagement and~     position of the fetal head and the outcome of labor in women with induced labor, and to~     compare the value of ultrasound measurements in predicting the time from induction to~     delivery and operative deliveries.~   "
236038|NCT00465985|"~     This study is designed to provide efficacy and safety data for ACZ885 (a fully human~     anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection~     subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.~      Part I is an 8-week open-label, active treatment period to identify ACZ885 responders.~      Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of~     ACZ885 compared to placebo.~      Part III is an open-label, active treatment period where patients will receive ACZ885 every 8~     weeks after withdrawal or completion of Part II.~   "
236039|NCT00465972|"~     This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use~     in patients who are HIV positive and suffer from insomnia.~   "
236040|NCT00465959|"~     To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD~   "
236041|NCT00465946|"~     Syncope is a syndrome consisting of a relatively short period of temporary and self-limited~     loss of consciousness caused by transient diminution of blood flow to the brain (most often~     the result of systemic hypotension). The objective of this study was to evaluate the effect~     of salt supplementation in vasovagal syncope prophylaxis.~   "
236042|NCT00465933|"~     The purpose of this study is to evaluate the efficacy of all-trans retinoic acid (ATRA) and~     idarubicin (AIDA) with a dose reduction in patients older than 70 years of age in the~     remission induction of acute promyelocytic leukemia (APL).~      With regard to the induction, the excellent results obtained by the combination of ATRA and~     idarubicin (AIDA), especially in terms of antileukemic efficacy (1% of resistance), do not~     support the introduction of substantial changes in this combination. However, given that most~     of the induction failures were caused by complications, especially of a hemorrhagic nature,~     and that these had a major impact in the hyperleukocytic forms and in patients older than 70~     years of age, the induction was modified as follows:~        1. Reduction of idarubicin dose in patients older than 70 years of age (three days instead~          of four);~        2. Early administration of corticosteroid therapy in all patients as ATRA syndrome~          prophylaxis. A preliminary analysis of the Italian Group for Adult Hematologic Diseases~          (Gruppo Italiano Malattie Ematologiche dell'Adulto, GIMEMA) has shown that low dose~          prednisone use in a prophylactic manner appears to reduce the incidence and severity of~          the ATRA syndrome, which could also have a favorable impact on the hemorrhagic mortality~          (non-published data); and~        3. Treatment of the hyperfibrinolysis with an antifibrinolytic agent (tranexamic acid). It~          has been recently reported that APL cells present abnormally high levels of annexins~          (especially annexin II), and that these levels may provide the fundamental mechanism for~          the hemorrhagic complications in APL by increasing the production of t-PA dependent~          plasmin. These findings provide new reasons for the introduction of tranexamic acid in~          the hemorrhagic prophylaxis of APL.~   "
236043|NCT00465920|"~     In the last decade cognitive behavioural therapy (CBT) approaches for patients with~     schizophrenia have been developed, which where especially designed to reduce severity of~     positive symptoms, readmission rates, treatment non-compliance and disability. Although CBT~     addresses the key problems of early onset psychoses (EOP)treatment and first evaluations of~     CBT in adults with schizophrenia are promising, no experience with CBT in adolescents with~     EOP are available. Therefore the present study is conducted to develop a modified CBT (mCBT)~     for adolescents with EOP, to explore its acceptance and feasibility and to provide data for a~     realistic estimation of achievable effect size. Patients are randomized to receive either~     mCBT+TAU or TAU over a 9 month period. mCBT is an individual outpatient treatment of 20~     session and 5 psychoeducational sessions with parents. Follow-ups for two years every 6~     months are planned.~   "
236044|NCT00465907|"~     Evaluate the efficacy and toxicity of the weekly combination chemotherapy of Paclitaxel,~     Carboplatin and Irinotecan in Stage IIIb and IV NSCLC with maligant pleural effusion~   "
236045|NCT00465894|"~     The purpose of this study is to determine if long acting tolterodine confers more benefit~     than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12~     weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen~     confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms.~     Secondary outcomes were to assess if the addition of the other therapy to the treatment~     regimen conferred benefit at 24 weeks and 52 weeks.~   "
236046|NCT00465881|"~     The purpose of this study is to obtain sufficient continuous glucose monitoring (CGM) data in~     a manner that provides clinical information that is not available using conventional~     self-monitored blood glucose. Currently, a formal method does not exist for evaluating CGM~     data except for looking at each glucose reading across the days a CGM system has been worn~     and evaluating it based on clinical practice experience. The hope is that a mathematical~     model can be developed that will enable health care providers to quickly and easily determine~     what changes in diabetes treatment need to be made after CGM data is obtained.~   "
236047|NCT00465868|"~     KoMPiS is a contrast aided cardiac magnetic resonance study of microvascular obstruction and~     left ventricular remodelling following acute revascularised anterior myocardial infarction.~     The study will monitor the included patients for 12 months following the acute myocardial~     infarct and collect data from MR scans and blood samples. The study is designed to~     demonstrate that obstruction of blood flow in the peripheral (small) vessels of the cardiac~     muscle is an important factor in the post-MI development of left ventricle dysfunction that~     occurs in many patients, despite of a successful re-opening of the occluded coronary artery~     that caused the MI.~   "
236048|NCT00465855|"~     This randomized trial will investigate important clinical outcomes of patients with acute~     carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen~     treatments.~   "
236049|NCT00465842|"~     Hepatocellular carcinoma (HCC) is the fifth commonest cancer in the world with poor~     prognosis, as the annual mortality is almost equivalent to the incidence. This is mainly due~     to late diagnosis and co-morbid liver dysfunction. HCC is prevalent in our region than in the~     West due to prevalent Hepatitis B infection and carriers. At the time of diagnosis, only 10 -~     20% of HCC patients are candidates for liver resection or transplantation. Almost 40-50% of~     patients have such poor liver function and co-morbid conditions that only supportive cares~     are offered. Thus the median survival time is 18-24 months for resectable disease, 6 months~     for unresectabe disease and 3 months for metastatic disease.~      Current screening methods for HCC in high risk patients depend on alpha-fetoprotein (AFP) and~     ultrasound of the liver. Neither test is sensitive or specific enough for early detection.~     Therefore, early diagnosis with novel protein biomarkers is needed urgently and may provides~     hope to improve treatment outcome.~      Our preliminary study in 49 HCC patients have identified several proteins such as truncated~     complement C3a, albumin, B2 microglobulin, may be potentially helpful in early diagnosis. We~     have started a large prospective and longitudinal study in July 2006, with nearly 100~     patients accrued. This application is to extend and expand our current study. We aim to (i)~     identify and validate novel protein biomarkers for early diagnosis of HCC (ii) conduct~     longitudinal proteomics with most up-to-date methods to discover new biomarker for early~     detection and prognostication of HCC (iii) set up gene and plasma depository and clinical~     database for HCC in collaboration with Singapore Tissue Network.~   "
236050|NCT00465829|"~     The primary objective of LABS-2 is to use standardized techniques and measures to assess the~     longer-term safety and efficacy of bariatric surgery by:~        1. comparing post-surgical outcomes to pre-operative status~        2. examining risks and benefits of surgery.~      LABS-2 will determine the associations between clinical/demographic patient characteristics,~     components of the surgical procedure, and peri-operative and post-operative care with~     post-operative risks and changes in patient status.~      Funds are not available to pay for the surgery for patients, only to address research~     questions.~   "
236051|NCT00465816|"~     This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine~     134612 when given in an experimental co-administration versus vaccine 134612 alone and versus~     the experimental co-administration alone in healthy subjects aged 11 through 17 years. There~     will be 3 groups in this study.~   "
236052|NCT00465803|"~     The purpose of this study is to assess patient compliance with DuoTrav versus concomitant~     administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular~     hypertension.~   "
236053|NCT00465790|"~     The main goal of the GENEPARK consortium is to employ innovative haemogenomic approaches to~     determine gene expression profiles specific for genetic and idiopathic Parkinson's disease~     (PD) patients. These gene expression signatures will be utilised clinically as non-invasive~     diagnostic tests for PD. The sensitivity of the newly developed diagnostic test will be~     determined by extensive validations on an independent cohort of PD patients, whereas the~     specificity will be assessed by testing patients with atypical parkinsonisms, including~     multiple system atrophy, progressive supranuclear palsy and diffuse Lewy body disease. In~     order to test the specificity of the diagnostic set in other disorders that affect basal~     ganglia, Huntington's disease and dopa responsive dystonia patients will be analysed. The~     second objective of the proposal is to determine correlations between gene expression~     signatures and different stages of PD and thus provide the basis for early diagnosis and~     monitoring of disease progression. These changes in blood gene expression will be correlated~     with alterations detected by neuroimaging in the brain of PD patients. Such combinations of~     molecular and morphological markers of disease may ultimately facilitate the selection and~     monitoring of neuroprotective therapies for PD. Finally, GENEPARK aims to develop new~     bioinformatic software tools for selection of genomic biomarkers using microarray data. A set~     of established computational tools will be applied and novel methods, some of them based on~     mechanistic modelling of the neurodegenerative diseases, will be developed in order to study~     the advantages and limitations of the different methodologies.~      With special emphasis on the careful clinical selection of patients and sufficient power~     regarding patient numbers, as well as extensive quality control and validation of the data,~     GENEPARK aims to develop a standardised approach to development and validation of~     haemogenomic biomarkers of disease.~   "
236054|NCT00465777|"~     The study intend to evaluate whether the use of standardised malaria case management protocol~     plus financial incentives added to the availability of free drugs reduce the case-fatality at~     the paediatric ward.~   "
236055|NCT00465764|"~     To compare the tolerance and early bone status of healthy, term infants fed formulas during~     the first three months of life.~   "
236056|NCT00465751|"~     The purpose of this study is to determine whether chenodeoxycholic acid decreases de novo~     hepatic lipogenesis, hepatic fat content, hepatic triglyceride production and plasma~     triglyceride concentrations and improves hepatic glucose metabolism in patients with the~     metabolic syndrome, Familial Hypertriglyceridemia and Familial Combined Hyperlipidemia.~   "
236057|NCT00465738|"~     This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the~     treatment of arm tightness (upper limb spasticity) using two different dilutions of~     incobotulinumtoxinA (Xeomin).~   "
236058|NCT00465725|"~     Picoplatin is a new platinum-based chemotherapy drug that has been studied in a variety of~     cancers. Phase 1 and 2 studies have demonstrated that picoplatin may be effective in patients~     whose cancer returns or does not improve after treatment with chemotherapy. In these studies,~     picoplatin was administered intravenously. A capsule containing picoplatin has been~     formulated. This study will investigate the activity of the oral capsule in humans.~     Participants with advanced solid tumors will be enrolled.~   "
236059|NCT00465712|"~     The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second~     external cephalic version after initial failure.Patient with a single foetus, at term, in~     breech presentation and after a first cephalic version are included. The randomisation~     determines whether the patient is included in the group with amnioinfusion before second~     cephalic version or with usual second cephalic version only; The efficacy's evaluation is~     based on rate of cephalic presentation at birth.Success rate of cephalic version with or~     without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal~     and fetal morbidity, time between second cephalic version and birth will be studied.~      Prospective interventional randomized sequential comparative multicentric study. A maximum of~     240 patients will be included (120 in each group). As the study is sequential it will be over~     as soon as a significative difference is shown.~   "
236060|NCT00465699|"~     This study is being done to see in B12 applied to the skin will improve the symptoms of~     eczema in children compared to a placebo creme~   "
236061|NCT00465686|"~     The purpose of this pilot study is to gather the data needed to do a larger research study to~     determine whether children with cerebral palsy print better sitting at an~     ergonomically-designed, custom-fitted school desk or at an oversized, standard school desk.~   "
236063|NCT00465660|"~     Female subjects over the age of 40 will be recruited and randomised into a progressive~     resistance training (PRT) or sham-exercise group. The PRT group will train at 80% of their~     peak strength, using Keiser pneumatic resistance machines, and progress approximately 3% per~     session. Strength will be re-assessed fortnightly. Exercises will target muscles around the~     hip and knee. The sham-exercise group will train on the same equipment as the PRT group~     except hip adduction, but without added resistance or progression. Both groups will train 3~     days per week for roughly 45 minutes for 6 months.~      It is hypothesised that high intensity PRT will decelerate the tibial and femoral cartilage~     degeneration in the knee affected most by OA.~      Primary Outcome:~      Articular cartilage morphology following 6 months high intensity progressive resistance~     training~      Secondary Outcomes:~      Muscle and fat cross-sectional area (CSA) (pre and post) Muscle strength, power, endurance,~     and contraction velocity (pre, 3 months, & post) Medications (pre, 3 months, & post) Body~     composition (pre, 3 months, & post) Balance; Physical function (pre, 3 months, & post)~     Questionnaires (pre, 3 months, & post)~        -  Habitual exercise (PASE) -WOMAC index (pain, stiffness and functional ability)~        -  Depressive symptoms (Depression Scale) -Quality of life (SF36)~        -  Confidence performing physical activity (Ewart) -Demographics~   "
236064|NCT00465647|"~     The primary objective of this study is to characterize the pharmacokinetics and~     pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16~     years inclusive. The secondary objectives are to characterize the safety and efficacy of~     hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.~   "
236065|NCT00465634|"~     To assess the role of uterine artery and maternal serum leptin and lipids and their~     combination in screening for pre-eclampsia and small-for-gestational-age (SGA) fetuses at~     20-24 weeks of gestation~   "
236066|NCT00465621|"~     The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807~     Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle in~     patients with open-angle glaucoma or ocular hypertension~   "
236067|NCT00465608|"~     Problem and Objectives: There is currently no pharmacological treatment for curing post~     traumatic stress disorder (PTSD). The investigators will test whether propranolol when given~     immediately after trauma evocation is able to decrease the strength of the traumatic memory,~     and by extension, the severity of PTSD symptoms associated with that memory.~      Hypotheses:~        1. The subjects will show a significant pre/post decrease in PTSD symptoms.~        2. Those gains will be maintained at follow-up.~      Study Design: Open pharmacological trial.~      Method: On the first visit (V1), the subjects will describe their traumatic experience in~     writing and will receive the propranolol. A script describing this experience will be~     constructed to be used in the subsequent encounters to elicit the trauma memory. A week later~     (V2), before receiving the propranolol, subjects will be asked to read aloud their trauma~     script while imagining it as vividly as possible for 10 minutes. This weekly treatment will~     be repeated 6 times (from V1 to V6). A total of 6 doses of propranolol will be given. A~     self-report measure will be used to monitor improvement in PTSD symptomatology on the~     following visits: V1, V4, V6, V7 and V8 (3 month follow-up).~      Statistical Analyses: A repeated measure ANOVA (pre-test, post-test, and 3-month follow-up)~     using the PTSD symptom score will be conducted.. Three t-tests will be performed to examine~     simple effects. The alpha level will be set at p = .05 (two-tailed). Fisher's exact test will~     be used to examine whether Ss still meet the diagnostic criteria for PTSD at the end of the~     study.~      Clinical Implications: If this treatment is effective, a randomized controlled trial will be~     launched. This treatment has the potential to become the first pharmacological treatment~     designed to cure PTSD.~   "
236068|NCT00465595|"~     This research is being done to study the psychological effects of psilocybin in cancer~     patients. Psilocybin is a naturally occurring substance found in some mushrooms that some~     cultures have used for centuries in religious practices.~   "
236069|NCT00465582|"~     Our main objectives are to evaluate the importance of meningococcal carriage and to determine~     the predisposing factors~   "
236070|NCT00465569|"~     The purpose of this study is to determine if small oral doses of milk protein are safe and~     effective in decreasing sensitivity to cow's milk in allergic children.~   "
236071|NCT00465556|"~     DOVE Home Visit Program is a brochure based intervention delivery by public health nurses~     which aims to prevent and reduce intimate partner violence against pregnant and postpartum~     women and their infants.~      The purpose of the study is to test the effect of home visits on reducing domestic violence~     and improving the lives of pregnant women and their children.~   "
236072|NCT00465543|"~     The purpose of this study is to evaluate the safety and efficacy of a new treatment for nasal~     polyps as compared to placebo (an inactive substance). The treatment involved is mint tea~     high in rosmarinic acid. Rosmarinic acid is a polyphenol, or a chemical substance found in~     certain plants such as oregano, rosemary, and the mints. It is the active ingredient in~     spearmint. The placebo used in this study will be mint tea low in rosmarininc acid. In this~     trial the amount of rosmarinic acid in the high rosmarinic acid tea, or study tea, will be~     150mg. The placebo, or low rosmarinic acid tea, will contain 10mg of rosmarinic acid.~   "
236073|NCT00465530|"~     Healthy children may develop symptoms of chronic sinusitis such as chronic cough, chronic~     runny nose, nasal congestion, even headaches. Such symptoms may persist long after the child~     gets over other symptoms of a cold and commonly result in the prescription of oral~     antibiotics. The purpose of this study is to evaluate whether using saline alone or saline~     plus an antibiotic (gentamycin) to irrigate the nose directly once a day for 6 weeks is~     effective and safe for the treatment of the above named symptoms. Computerized axial~     tomography (CAT) scans and quality of life surveys will be used to compare the health of the~     sinuses before and after treatment, and scored to determine which of the two treatments,~     saline alone or saline with gentamycin, is more effective in the treatment of this condition.~     The study hypothesis is that intranasal saline irrigation will work as well as saline plus~     gentamycin, and that majority of the patients will experience significant improvement after a~     6 week treatment period.~   "
236143|NCT00464607|"~     Purpose of the study is the evaluation of the tolerability (both local and systemic) and the~     clinical efficacy (in terms oocytes recovered) of subcutaneously versus intramuscularly~     administered Merional® (IBSA, Lugano – CH) in patients undergoing controlled ovarian~     hyperstimulation (COH) in an ART programme (IVF).~   "
236075|NCT00465504|"~     Chronic arthritis (inflammation of joints) in children is known as Juvenile Idiopathic~     Arthritis (JIA). Often, to control the swelling and to help reduce the pain in the joint,~     medications (steroids) are injected into the joint. These injections are sometimes painful,~     even if we use local anesthetics (lidocaine) to numb the skin; in fact, lidocaine injection~     is often the most painful part of the procedure. There is an alternate method called~     iontophoresis that uses an electric current to push lidocaine into the skin and deeper~     tissues avoiding the anesthetic injection. Very little work has been done to see if this is~     actually an effective way of numbing the skin in children having painful procedures such as~     joint injections. In this study, we will compare two groups of children with JIA having~     steroid injections into their joints: one group will get lidocaine by iontophoresis and the~     other will get it by the usual injection method. We will assess the child's pain during the~     steroid injection and compare the two groups to see if children who are given local~     anesthetic by iontophoresis experience less pain. The results of this study will provide new~     information about the effectiveness of the iontophoresis method, and whether or not this~     would be a better way to give local anesthetic for children undergoing other kinds of painful~     procedures.~   "
236076|NCT00465491|"~     Picoplatin is a new type of platinum drug that has been investigated in several clinical~     trials, and may provide an improved safety profile over current treatment options. This study~     is designed to compare the efficacy and safety of picoplatin plus Best Supportive Care (BSC)~     with BSC alone. Best Supportive Care includes care and treatment to optimize the comfort of~     patients and their ability to function, as well as to minimize the side-effects of~     anti-cancer treatments.~   "
236077|NCT00465478|"~     The study evaluates the safety and efficiency of autologous bone marrow mononuclear cell~     transplantation in treating patients with type 1 or 2 Diabetes Mellitus. We hypothesize that~     autologous bone marrow stem cell transplantation will promote β-cells regeneration by~     directly differentiated from the transplanted BMMCs or stimulated local stem cells~     regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells~     function.~   "
236078|NCT00465465|"~     The dose of recombinant MVA used in the TB trials to date is relatively low compared with~     other trials using recombinant MVAs which have used up to 2.5 x 108pfu (A Hill, personal~     communication). Having demonstrated safety and immunogenicity of 5 x 107pfu of MVA85A, we now~     need to perform a dose optimization study, prior to commencing larger scale Phase II and III~     studies in South Africa. We will vaccinate 12 volunteers with a dose half a log lower than~     the dose we are currently using, i.e. 107pfu MVA85A, and 12 volunteers with a dose half a log~     higher, i.e. 108pfu.~   "
236079|NCT00465452|"~     The purpose of this proposal is to determine if switching PD patients treated with~     pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by~     these patients. Side effects that we will monitor in particular include somnolence,~     peripheral edema, cognitive decline with and without hallucinations. PD patients followed in~     the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least~     one of the following symptoms: somnolence, cognitive impairment with or without~     hallucinations, or peripheral edema will be offered the opportunity to participate in this~     study.~   "
236080|NCT00465439|"~     This randomized controlled trial will examine the impact of local anesthetic on the frequency~     of vasovagal reactions and the patients perception of pain during femoral arterial sheath~     removal after percutaneous coronary intervention.~   "
236081|NCT00465426|"~     HIV-infected patients treated with combination antiretroviral therapy demonstrate metabolic~     abnormalities that may predispose them to cardiovascular disease. In HIV-infected patients we~     will investigate progression rates of cardiovascular disease and assess whether these~     progression rates are predicted by increased inflammatory indices.~   "
236082|NCT00465413|"~     The purpose of the present study is to determine whether use of a small volume spacer is~     associated with better bronchodilatation in an unselected population of patients with~     documented reversible airflow limitations.~   "
236083|NCT00465400|"~     First, to quantify, by means of comet assay analysis, systemic oxidative stress in patients~     with non-exudative and exudative age-related macular degeneration (AMD) and compare results~     to healthy controls.~      Second, to quantify systemic oxidative stress in patients with exudative AMD prior to and~     after photodynamic (PDT) therapy.~   "
236084|NCT00465387|"~     Falls and osteoporosis-related fractures cause substantial morbidity and mortality in the~     elderly, and are an increasingly important public health concern. A comprehensive~     multidisciplinary and integrated community-based approach is needed to identify and manage~     the population at highest risk of these complications. Unfortunately, current gaps in~     continuity of care and health intervention result in a sub-optimal state of health service~     for these individuals. The Falls, Fracture and Osteoporosis Risk Control and Evaluation~     (FORCE) Study is a two-year randomized controlled trial evaluated on the effect of~     coordinated community-based, multidisciplinary approach for fall and fracture prevention in~     Sault Ste. Marie.~   "
236085|NCT00465374|"~     30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of~     hyperinflation. Functional analysis of pressure-time curve (Stress Index=SI) has been shown~     to identify this condition in experimental settings. We tested the hypothesis that the SI is~     an accurate predictor of mechanical stress due to overdistention in ARDS patients.~   "
236086|NCT00465361|"~     The purpose of this study is to evaluate the efficacy of individualized performance feedback~     coupled with an educational module in improving resident performance of the physical and~     developmental examination component of developmental surveillance of infants at the two month~     preventive care visit.~   "
236087|NCT00465348|"~     To quantify oxidative stress in circulating leukocytes of normal tension glaucoma patients,~     prior to and one month after routine vascular therapy.~   "
236088|NCT00465335|"~     The purpose of this study is to evaluate the usefulness of performing a cat scan of the~     heart arteries in patients (without a known history of heart disease) seen by their physician~     for chest pain. We plan to evaluate this test in patients who have already undergone stress~     testing. On occasion, stress test results are equivocal or suspected to be inaccurate. In~     these cases, depending on the overall clinical suspicion of coronary artery disease,~     physicians may recommend cardiac catheterization to determine whether or not patients have~     blockages in their heart's arteries. We plan to evaluate whether a Cat Scan of the heart~     arteries will provide your physician with important information to assist in this decision.~     If the results of this test are normal, the patient may not require a heart catheterization;~     alternatively, if the test is abnormal, a physician may proceed with catheterization after~     review of the data. There will 200 patients enrolled into the study. All patients will be~     followed by their usual cardiologist, and all decisions will be made by their cardiologist.~      Computed tomography (CT; cat scan) is an x-ray test routinely used for diagnostic purposes.~     Cardiac computed tomography using the newer generation multislice CT (MSCT) scanners is an~     improved way of using CT scanning techniques to look at the heart and blood vessels of the~     body. The images of the coronary arteries obtained by MSCT scanners (during a 5-10 minute~     procedure) are highly accurate, when compared to the conventional invasive cardiac~     catheterization procedure. This procedure will provide a calculation of a coronary artery~     calcium score as well as an accurate depiction of the coronary anatomy. The accuracy of this~     test is similar to that achieved with traditional stress test imaging, but has some inherent~     advantages over this traditional stress testing. Therefore, we believe that in patients with~     intermediate, inconclusive, or suspected inaccurate stress tests, MSCT of the coronary~     arteries may provide helpful information to your physician to help guide their decision~     regarding the need (or lack of) for possible invasive cardiac catheterization. This procedure~     is considered an ideal screening test to exclude the presence of coronary artery disease in~     patients with suspected coronary artery disease.~      On the day of your procedure, the patient will be given intravenous (IV dye) contrast~     during their Cat Scan. We will also draw a blood sample to assess your kidney function and/or~     pregnancy status (if necessary). The contrast is what creates the pictures of one's arteries.~     The intravenous contrast used is the same dye as that used for routine cat scans of other~     parts of the body, as well as for cardiac catheterization. Prior to the Scan patients may be~     prescribed a medicine called a beta blocker The beta blocker typically used is called~     Atenolol. This medication slows your heart rate and is one that is commonly used to treat~     high blood pressure. Dosing will be based upon your current medications and vital signs. If a~     patient's heart rate is greater than 60 beats per minute an intravenous beta-blocker may be~     given to optimize their heart images. Patient's will have to hold your breath twice, for up~     to 30 seconds each time. The imaging part of the test takes about 10 minutes. Patient's will~     be observed after the test for about 20 minutes, followed by discharge home. Physicians will~     called with the patient's results of the study, and they will contact their patient's~     regarding the results, as well as the next step. If a patient is a diabetic (taking~     metformin/glucophage), we will request a follow up (the next day) kidney test. Patient's will~     also will be called at 3 months to asked a few brief questions regarding your health (any~     recent hospitalizations, any new medical illnesses, any follow up heart testing, etc.)~   "
236089|NCT00465322|"~     The purpose of the study was to determine the influence of fluvastatin and atorvastatin on~     platelet aggregation in patients treated with aspirin and plavix after coronary stenting. We~     hypothezied a positive effect of fluvastatin on platelet aggregation levels.~   "
236144|NCT00464594|"~     The purpose of this study is to compare the suppressive effect of two kinds of interventions~     on the worsening/progression to definite diabetes: standard lifestyle guidance and standard~     lifestyle guidance combined with pharmacological intervention (monotherapy with one of~     acarbose, metformin, or gliclazide).~   "
236090|NCT00465309|"~     30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and~     functional (Stress Index>1) conditions of hyperinflation even with Plateau pressure (Pplat) <~     30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more~     protective ventilation.~      In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my~     allow the reduction of Tidal Volume (Vt) and Pplat.~   "
236091|NCT00465296|"~     The primary objective of this clinical trial is to assess the efficacy of rosiglitazone on~     bare metal stent (BMS) in-stent restenosis measured as late lumen loss in patients with~     metabolic syndrome.~      The secondary parameter for evaluation of efficacy is binary restenosis.~      The tertiary objective will be to assess the effect of rosiglitazone on major cardiac events~     (MACE; death, MI, CABG, and target vessel revascularization). The occurrence of in-stent~     restenosis for patients with metabolic syndrome who receive a DES in a non-target lesion will~     be assessed angiographically at 9 months.~   "
236092|NCT00466388|"~     The purpose of this study is to determine the effectiveness of cevimeline (versus placebo) on~     the oral health of patients who have dry mouth which was caused by radiation therapy that was~     given for treatment of head and/or neck cancer.~   "
236093|NCT00465283|"~     This is a double blind randomized investigation of donepezil for patients suffering from~     schizophrenia, undergoing ECT.~      Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether~     donezepil has a protective effect on memory disfunction, while patients are treated with ECT.~     Several parameters will be invistigated at baseline: general psychopathological measures,~     memory function scales, side effects scales. The same measurements will be taken throughout~     the trial and one month after ending the ECT.~   "
236094|NCT00465270|"~     The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO)~     closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical~     treatment in the prevention of recurrent embolic stroke.~   "
236095|NCT00465257|"~     The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years~     after its introduction as first line treatment for uncomplicated childhood malaria in~     Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted~     parasitological cure rate of at least 85% 42 days after treatment.~   "
236096|NCT00465244|"~     The overarching aim of STILL is assessment of IV LEV in the management of seizures in the ED~     setting. The main study endpoints are considered in the two patient groups of interest (SE~     and non-SE):~        -  For non-SE patients, STILL will compare IV LEV vs. the current standard-care of placebo,~          with respect to the following questions:~        -  Does IV LEV administration result in lower seizure duration and/or recurrence rate than~          does administration of placebo? (Ho: No difference in seizure duration or recurrence~          rates between the two groups.)~        -  Is IV LEV associated with a different rate of significant side effects than placebo?~          (Ho: No difference in significant side effect rates between the two groups.)~        -  For SE patients, STILL will compare [IV LEV + lorazepam 2mg] vs. [lorazepam 3 mg], with~          respect to the following questions:~        -  Does addition of IV LEV to a BZD allow for a BZD-sparing effect (i.e. achievement of~          seizure control with lower dose of BZD)? (Ho: No difference in seizure duration and/or~          recurrence rates between the two groups.)~        -  Is IV LEV + lower-dose BZD associated with a different rate of significant side effects~          than the higher-dose BZD administered as monotherapy? (Ho: No difference in significant~          side effect rates between the two groups.)~   "
236097|NCT00465231|"~     Our study is about providing a better birthing experience by placing and initiating epidural~     for labour pain before the contractions start. This concept of prevention of pain before its~     onset is known as preventive - or preemptive -pain management and is well known in surgical~     and anaesthetic practice. We believe that the use of preventive epidural analgesia will~     improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress~     response to labour and delivery.~   "
236098|NCT00465218|"~     The purpose of this study is to determine if there is any difference in the counts of~     cerebral emboli and platelet function between two prophylactic treatments of thrombosis~     currently used at University of Ottawa Heart Institute for the first three months after~     surgery in low-risk patients undergoing aortic valve replacement with a bioprosthetic valve:~     1) daily use of high-dose aspirin [325 mgs], and 2) the combination of oral Warfarin [target~     INR 2.0 to 3.0] and low-dose aspirin [81 mg].~   "
236099|NCT00465205|"~     Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical~     and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The~     evidence suggests that HSV is an important co-factor in HIV transmission.~      The trial's purpose is to assess the reduction in HIV systemic and mucosal replication~     associated with valacyclovir for suppression of HSV-2 reactivation.~      This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected~     women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.~   "
236100|NCT00465192|"~     This trial was conducted in the United States of America (USA). This trial aimed for a~     comparison between the effect of two different doses of estradiol on parameters related to~     efficacy and safety.~   "
236101|NCT00465179|"~     The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib~     malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The~     safety of sunitinib malate will also be studied.~   "
236102|NCT00465166|"~     Accidental dural puncture is a potential complication of epidural analgesia for labour and~     delivery. When it happens, it may cause debilitating headaches and other symptoms that~     prevent mothers from talking care of their newborns. Accidental dural puncture is related to~     the operator performance and to individual anatomical variations of the spine. The purpose of~     this study is to do a lumbar spine ultrasound on the patients who have had accidental dural~     punctures and analyze if there is any abnormal anatomy seen. Then, we will compare the~     position of any spinal abnormality to the position of the dural puncture reported in the~     anaesthesia record.~   "
236156|NCT00464438|"~     This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic~     solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of~     age~   "
236511|NCT00459693|"~     The purpose of this protocol is to measure a receptor in the brain using positron emission~     tomography (PET) that is involved in inflammation.~   "
236103|NCT00465153|"~     Loss of muscle mass and functional ability is a major concern for older individuals. Aging is~     associated with increased inflammation caused by release of hormone-like compounds termed~     cytokines which are involved in muscle protein degradation. Diets rich in ω-3 fatty acids~     decrease the production of pro-inflammatory cytokines, possibly by inhibiting production of~     lipids involved in cytokine synthesis. Our purpose is to assess the effect of dietary~     supplementation with an ω-3 fatty acid, α-linolenic acid (ALA) commonly found in flaxseed,~     combined with resistance training on pro-inflammatory cytokines, strength, and muscle mass in~     older adults. Progressive resistance training is considered to be the standard for increasing~     strength and muscle mass in older adults. We hypothesize that combining the two interventions~     will improve strength and muscle mass more than resistance training alone by modulating the~     inflammatory process associated with aging. Our proposed research will compare older~     individuals supplementing with ALA and placebo during a resistance training program.~   "
236104|NCT00465140|"~     Creatine (CR) supplementation is commonly used by athletes. However, its effects on renal~     function remain controversial. The aim of this study was to evaluate the effects of creatine~     supplementation on renal function and oxidative stress in healthy sedentary males (18-35~     years old) submitted to exercise training. Our hipothesis is that creatine supplementation~     does not affect renal function in this population.~   "
236105|NCT00465114|"~     Severe preeclampsia often presents with uncontrolled hypertension and therefore requires~     close monitoring of blood pressure and cardiac performance.~      The purpose of the study is to compare two methods of measuring the performance of the heart~     in pregnant women: one by ultrasound of the heart, the other by assessing the pulse generated~     in the blood vessel of the wrist. We hope that the method using pulse analysis will be as~     effective as ultrasound, which is labour intensive and operator dependant.~   "
236106|NCT00465101|"~     To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and~     coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary~     tract symptoms.~   "
236107|NCT00465088|"~     To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin~     (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating~     effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are~     currently off lipid-modifying therapy. This was a prospective, randomized, open-label,~     blinded endpoint (PROBE) study.~   "
236108|NCT00465075|"~     The primary objective is to determine the effect of a high-fat meal on the bioavailability~     and PK of a single, oral dose of BZA/CE (PNP) 20mg/0.625 strength tablet, assessing both the~     BZA and CE components.~   "
236109|NCT00465062|"~     Gaucher disease is a lysosomal storage disorder resulting from a deficiency in the key enzyme~     b-glucocerebrosidase (GCase). This enzyme is responsible for breaking down a specialized type~     of fat molecule, known as glucocerebroside, in the lysosome. The enzyme deficiency is caused~     by genetic mutations which result in the production of misfolded GCase protein. The absent or~     defective GCase enzyme activity leads to build-up of glucocerebroside inside certain cells.~     Over time, these Gaucher cells can accumulate and may cause inflammation or damage to~     specific areas within the body, including the liver, spleen, bone marrow, lung, and the~     central nervous system.~      AT2101 is designed to act as a pharmacological chaperone by selectively binding to the~     misfolded GCase. After binding to the enzyme, it is thought that AT2101 promotes the proper~     folding, processing, and trafficking of the enzyme from the endoplasmic reticulum to its~     final destination, the lysosome, the area of the cell where the enzyme does its work. Once it~     reaches the lysosome, the pharmacological chaperone is displaced and the enzyme can perform~     its normal function, which is the breakdown of its natural substrate, glucocerebroside.~      Several in vitro and in vivo preclinical studies have been conducted. In these studies AT2101~     increased GCase enzyme level in cells derived from Gaucher disease patients with different~     genetic mutations, including cells with a genetic mutation associated with the neurologic~     form of Gaucher disease. In normal mice, oral administration of AT2101 resulted in a~     dose-dependent increase in GCase level in the liver, spleen, brain, and lung.~      This study is designed to evaluate the ex vivo response to pharmacological chaperone therapy~     by testing blood samples from previously treated and untreated patients with Gaucher disease.~     The study will include patients with non-neuropathic Gaucher disease (type I) and neuropathic~     Gaucher disease (types II and/or III). Up to 50 patients will be enrolled at the NIH.~      All subjects will participate in one study visit. Clinical information will be collected~     retrospectively from medical records. Information collected will include Gaucher disease~     diagnosis and history, medical history, family history, assessments of clinical severity, and~     genotype. A blood sample will be collected and various cells will be isolated for laboratory~     testing and research.~   "
236110|NCT00465049|"~     The standard treatment for skin abscesses in drainage followed by packing to prevent~     premature closure and reaccumulation of pus. Studies from the 1950s and later conducted~     outside of the US suggest that when drained abscesses are drained and sutured closed they~     actually heal faster without complications. The current study compares the time to healing~     and scar formation when drained abscesses are packed or sutured.~   "
236111|NCT00465036|"~     Randomized trial to test the effect of flaxseed fractions on appetite regulation and~     intestinal lipid absorption.~   "
236112|NCT00465023|"~     The main purpose of this study is to determine if high doses of radiation using proton beam~     can be given safely with low and acceptable side effects. We will also gather information to~     determine the ability of proton beam to destroy cancer cells in the liver. There are two~     types of external radiation treatments (proton beam and photon beam). Proton beam radiation~     is a very accurate kind of treatment that has been shown to affect less normal tissue than a~     regular radiation beam. The accuracy allows us to more safely increase the amount of~     radiation delivered to eliminate cancer and may potentially reduce the side effects normally~     experienced with standard radiation therapy.~   "
236113|NCT00465010|"~     Many adolescents in the U.S., even very young adolescents, are engaging in sexual risk~     behaviors that put them at risk for sexually transmitted diseases (STDs) and unintended~     pregnancy. Studies show that parents can play a significant role in promoting healthy sexual~     development and risk reduction among adolescents. The UCLA/RAND Center for Adolescent Health~     Promotion has developed Talking Parents, Healthy Teens, a worksite-based parenting program~     for parents of adolescents (grades 6-10) to improve parent-adolescent communication and~     reduce adolescent sexual risk behaviors. We are evaluating the effectiveness of the program~     primarily with confidential surveys of the participants before and after the program.~   "
236114|NCT00464997|"~     High dose aspirin have been shown to increase the level of Methotrexat in patients with~     Rheumatoid Arthritis. However, most of RA patients are not currently treated with high dose~     aspirin. On the other hand, they frequently receive treatment with low dose aspirin. The~     effect of low dose aspirin on the levels of Methotrexate is not well known. Therefore,the~     purpose of this study is to assess the effect of low dose aspirin on the levels of~     methotrexate.~   "
236205|NCT00463775|"~     The objective of the present study is to evaluate the efficacy of topiramate (250mg/day)~     versus placebo in decreasing aggression and reducing alcohol consumption in patients with~     borderline personality disorder (BPD) and alcohol dependence (AD).~   "
236115|NCT00464984|"~     The long term effects of organized lifestyle intervention on weight loss, physical fitness~     and quality of life in morbidly obese patients have not been extensively studied. The~     objective of this study is to investigate whether an intensive lifestyle intervention program~     in a tertiary care clinic (Spesialsykehuset for Rehabilitating) is superior to lifestyle~     intervention in a primary care setting with respect to long term (4-years) changes in weight~     loss, physical fitness and quality of life~   "
236116|NCT00464971|"~     This trial was conducted in the United States of America (USA). This trial aimed to evaluate~     safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.~   "
236117|NCT00464958|"~     Open label, one year extension study to evaluate the clinical efficacy and safety of 12 mg~     sublingual tizanidine administered once nightly in MS patients who successfully completed~     Phase I/II protocol C2/5/TZ:MS-05 at the Tel Aviv Sourasky Medical Center, Department of~     Neurology, Dr. Arnon Karni, PI.~   "
236118|NCT00464945|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of~     manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale~     13vPnC in healthy infants when given with routine pediatric vaccines.~   "
236119|NCT00464932|"~     This study, a new immunomodulatory therapy of COPD with vasoactive intestinal peptide (VIP)~     was evaluated. Based on preliminary unpublished clinical and experimental results, the course~     of disease under VIP treatment and the molecular mechanisms involved were assessed.~      34 patients with severe COPD were treated either with VIP inhalation in addition to~     conventional therapy or inhalation of placebo plus conventional therapy for a period of 3~     months. The trial was conducted as a double blind, comparative study with two parallel~     groups.~   "
236120|NCT00464919|"~     The prognosis for patients with metastatic or locally advanced hepatocellular carcinoma (HCC)~     is poor. The role of conventional systemic chemotherapy has been very limited because most~     chemotherapeutic agents are in-effective and relative toxic to HCC patients who tend to have~     poor organ function reserves due to liver cirrhosis. The molecular-targeted therapy, which~     aims at deranged signaling pathways of cancer cells or their microenvironment, holds promise~     for HCC.~      Sorafenib (BAY 43-9006), a novel bi-aryl urea, is a potent inhibitor of VEGFR2 and Raf~     kinase. The clinical activity of sorafenib in HCC has been tested in a phase II study (Bayer~     study 10874), which enrolled a total of 137 advanced HCC patients. There were 4% of~     documented partial response, 5% of minor response, and 55% of stable disease. The 6- month~     progression -free for the cohort was 40%. Currently, there are two on-going large-scale~     randomized trials of sorafenib in advanced HCC patients worldwide.~   "
236121|NCT00464893|"~     Primary evaluation of the safety, tolerability and feasibility regarding specific~     postoperative complications of an adjuvant treatment with catumaxomab administered after~     curative tumor resection subsequent to a neoadjuvant chemotherapy.~   "
236122|NCT00464880|"~     This study will assess the reno-protective effect of renin inhibition with aliskiren as an~     alternative to irbesartan in type 2 diabetes patients with incipient/overt diabetic~     nephropathy.~   "
236123|NCT00464867|"~     Cholera is a major health problem of many developing countries and marked increase in the~     prevalence has been seen on all continents in the last decade (WHO 1998). There is a great~     need for an appropriate vaccine to protect children the principal suffers in endemic~     countries, from the live threatening consequences of cholera. The B subunit-whole cell killed~     vaccine (Dukoral) developed in Sweden and used in field trials all over the world. It is~     licensed in many counties of the world and recommended by WHO. Protective efficacy to the~     killed vaccine has been demonstrated in adults in Bangladesh as well as in other countries,~     but less so in children (Clemens et al. 1986). Thus there is an urgency for developing~     strategies to improve the immunogenicity of vaccines especially for protection of children in~     cholera endemic countries of the world. Different options for improved cholera vaccines are~     being considered including new and improved formulations of killed or live oral candidate~     vaccines (Qadri et al. 2004, Sack et al. 1997, Levine et al. 1993) as well as the use of~     micronutrient supplementation during the course of immunization (Albert et al. 2003, Karlsen~     et al. 2003, Qadri et al. 2004). Another option that appears promising is the use of~     probiotics as adjunct to oral immunization based on the understanding that these agents could~     improve the mucosal immune responses, both innate and adaptive and help reducing inflammation~     (Blum and Schiffrin 2003, Fang et al. 2000). A therapeutic as well as preventive role of~     probiotics has been suggested from results of different studies using different probiotics~     that have been tested, usually lactic acid producing bacteria such as lactobacillus,~     Bifidobacterium and Steptococcus species. The supplemention of probiotics to infants may also~     have a prophylactic effect against acute diarrheal diseases. In pediatric populations, the~     effect of probiotic agents appears to be most significant against rotavirus diarrhea,~     suggesting that an immunological mechanism is responsible for the beneficial effects~     (Saavedra, 2000). In the present proposal we would like to examine if supplementation with~     the probiotic Bifidobacterium breve has a beneficial role in enhancing the immunogenicity of~     Dukoral in children. A two cell study will be conducted in which one group of children will~     be given B. breve every day for four weeks and another group will be given placebo. Two doses~     of the oral cholera vaccine will be administered at two week interval following initiation of~     the probiotic/placebo administration. Pre- and post- vaccination blood sample will be~     collected and assayed for immune response to the vaccine. The frequency and magnitude of the~     immune response to the vaccine will be compared among the two groups of children to assess~     whether the probiotic treatment enhances the immune responses to the vaccine. If probiotic~     supplemenation has a positive effect on the immune response it may be adopted as adjunct to~     enhance the efficacy of the cholera vaccine in immunization programmes and perhaps also of~     other enteric vaccines.~   "
236124|NCT00464854|"~     At least 20% of patients hospitalized in the general medical and surgical wards at any given~     time suffer from diabetes. It has been demonstrated that poor clinical outcome correlates~     with the degree of hyperglycemia in these patients. Strict glucose control in hospitalized~     patients improves clinical outcomes in the setting of acute myocardial infarction, cardiac~     surgical procedures, infection and critical illness in patients hospitalized in intensive~     care units if insulin is applied intravenously. It is, however, complex to obtain strict~     glucose control in the general surgical and medical wards. These wards are usually~     understaffed as compared to intensive care units and therefore are incapable to perform the~     necessary close monitoring essential in patients treated with intravenous insulin. We intend~     to test the feasibility of glucose control by multiple daily subcutaneous injections with~     long acting basal glargine insulin and pre-meal insulin analogues. If good glucose control~     can be achieved, this would be a valid, more convenient and acceptable alternative to~     intravenous insulin infusions to obtain good glucose control in diabetic patients~     hospitalized in general internal medicine wards.~   "
236125|NCT00464841|"~     Combined spinal epidural anesthesia (CSE) is a very effective technique to provide labor~     analgesia. One of the disadvantages of this technique is the delay in recognizing an error in~     the position of the epidural catheter because of the effects of the spinal component.~     Eventually in case of a misplaced catheter, the patient will experience pain or discomfort~     requiring a repeat procedure after the effect of drug given during the spinal wears off. Low~     current electrical stimulation test, or the Tsui test, has been used successfully to confirm~     catheter location in the epidural space. The investigators' objective in this study is to~     test the usefulness of the Tsui test to confirm the correct placement of the epidural~     catheter during CSE in laboring patients.~   "
236126|NCT00464828|"~     There is no data regarding success rates and incidence of carotid punctures during central~     venous cannulation (CVC) in the pregnant patients. We hypothesize that because of the~     anatomical and physiological changes associated with pregnancy, these patients are at higher~     risk of procedure failure and carotid puncture than the general population. The purpose of~     our study is to determine the success rate and incidence of carotid punctures using an~     ultrasound-simulated procedure in pregnant and non-pregnant patients.~   "
236127|NCT00464815|"~     The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority~     of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.~   "
236128|NCT00464802|"~     The primary objective is to determine the safety and tolerability of the new IV formulation~     versus the current formulation of MOA-728 focusing on the theoretical potential for~     infusion-related and formulation-related complications.~   "
236129|NCT00464789|"~     Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed~     for treatment of menopause. The purpose of this trial is to compare a new manufacturing~     process for making BZA/CE to the current process by assessing the way it is absorbed into the~     blood.~   "
236130|NCT00464776|"~     This study will assess the optimal renoprotective dose of Aliskiren in hypertensive type 2~     diabetes patients with incipient or overt nephropathy~   "
236131|NCT00464763|"~     The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the~     prevention of postoperative delirium in subjects undergoing heart valve surgery with or~     without coronary artery bypass surgery (CABG) using cardiopulmonary bypass (CPB).~   "
236132|NCT00464750|"~     This study tests the reliability of thermodilution cardiac output measurements with pulmonary~     artery catheters in immediate connection with heart surgery. In accordance with our clinical~     practice, thermal indicator injections are synchronized with respiration. The impact on~     measurement repeatability of spontaneous vs artificial ventilation and the effect of the~     injectate temperature is tested.~      The study hypothesis is that when injections are synchronized with the respiration, only~     three injections at room temperature are needed to be within 5 % of the true cardiac output~     in mechanically ventilated patients.~   "
236133|NCT00464737|"~     This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in~     reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain,~     sleep, general activity, mood, and quality of life, and the use of rescue medication to treat~     pain will be assessed.~   "
236134|NCT00464724|"~     Objectives:~      The objectives of this study are to: 1) evaluate the feasibility of 3T MRSI of prostate in~     improving the spectral resolution, using a PFC-filled endorectal coil, 2) develop a~     systematic metabolic grading system for tumor detection by identifying the abnormal peak~     areas of Cho, Cr, Po, and Ci for the prostate carcinoma, specifically from PFC-filled~     endorectal 3T MRSI, and 3) evaluate the efficacy of the metabolic grading system in tumor~     detection.~      The long-term goal of the study is to provide an early prognostic indicator and means of~     monitoring the biologic status of the prostate cancer during the course of the disease.~   "
236135|NCT00464711|"~     This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to~     treatment with escitalopram in people with major depressive disorder.~   "
236136|NCT00464698|"~     The purpose of this study is to assess the efficacy of Duloxetine in the treatment of~     obsessive compulsive disorder.~   "
236137|NCT00464685|"~     This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone~     with laser treatment vs. laser treatment alone in patients with diabetic macular edema.~   "
236138|NCT00464672|"~     This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the~     2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in~     the EU and many other worldwide countries, according to the US FDA Draft Guidance for~     Industry Clinical data needed to support the licensure of trivalent inactivated influenza~     vaccine, issued in March 2006, and to evaluate safety, clinical tolerability and~     immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional~     influenza vaccine already licensed in US. The purpose of the control arm is primarily to~     provide a comparative assessment for safety, not immunogenicity or effectiveness.~   "
236139|NCT00464659|"~     The main objective of this study is to evaluate the evolution of memory deficit (verbal~     episodic memory, procedural memory, working memory, short-term memory) in Sleep Apnea~     Obstructive Syndrome (SAOS) patients after treatment by Continuous Positive Airway Pressure~     treatment (CPAP). For thus, we will compare memory tests in two separate groups of SAOS~     patients with effective  versus ineffective ( or sham) CPAP, before and 6 weeks after the~     beginning of the treatment. Thus we will assess the evolution of memory deficit, the~     effectiveness of the treatment on the evolution of memory deficit before and 6 weeks after~     the beginning of the treatment by effective  versus ineffective CPAP.~      We feel the results of the tests of memory will show greater memory disorders in patients~     with SAOS before beginning the treatment rather than six weeks afterwards. Thus we~     hypothesise that, after the treatment by effective CPAP, the patients with SAOS will have~     greater improvement of their memory disorders than those treated by sham CPAP.~   "
236140|NCT00464646|"~     The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab~     to treat HER2-positive breast cancer will affect heart function. This study will evaluate:~        -  How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab~          after surgery, will affect breast tumors~        -  Side effects from adding bevacizumab to chemotherapy and trastuzumab~        -  Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect~          the heart~        -  If receiving bevacizumab will have any effect on how patients recover from surgery~   "
236141|NCT00464633|"~     Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic~     leukemia patients.~      Primary objective is to determine overall response rate.~      The secondary objectives are:~        -  to assess overall safety,~        -  to assess duration of response, progression free survival, and overall survival.~      Clinical benefit and pharmacokinetics parameters are also evaluated.~   "
236142|NCT00464620|"~     This study will examine the response rate and the 6-month progression-free survival rates of~     subjects with advanced sarcoma treated with dasatinib.~   "
236145|NCT00464581|"~     Cystoid macular edema (CME) is the most common cause of suboptimal post-operative visual~     acuity in uncomplicated cataract extractions. Over two million cataract extractions are~     performed each year, with a reported incidence ranging from 1.5 to 6.9%, resulting in an~     estimated 20,000-130,000 new cases of CME annually. Clinical CME historically was associated~     with visual acuity of 20/40 or worse with fluorescein angiographic evidence of macular edema~     in a classic petaloid pattern. Angiographic CME physiologically signals an inflammatory~     process causing distortion of the outer plexiform layer, which if not resolved quickly could~     result in non-repairable visual loss. Topical, periocular, or intravitreal corticosteroids,~     despite their associated side effects, are the mainstay for pharmacologic treatment for~     patients with CME. Their efficacy has never been demonstrated in a randomized, controlled and~     blinded study.~      This is an open-label, Phase II study of intravitreally administered ranibizumab in subjects~     with cystoid macular edema secondary to non-ischemic retinopathy, as seen following cataract~     surgery with intraocular lens implantation.~   "
236146|NCT00464568|"~     This current study is planned as a dedicated pharmacodynamic (effect of drug on the body)~     study to investigate the dose response in rhinitic subjects at doses where GSK256066 has been~     proven to work (200mcg) or expected to (50mcg) work. This study also aims to investigate the~     lower end of the predicted therapeutic range.~   "
236147|NCT00464555|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells~     are destroyed, resulting in poor blood sugar control. The purpose of this study is to~     determine the safety and effectiveness of islet transplantation, combined with~     immunosuppressive medications and medications to support islet survival, for treating type 1~     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic~     episodes.~   "
236148|NCT00464542|"~     This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of~     HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.~   "
236149|NCT00464529|"~     The purpose of this study is to determine the safety and accuracy of the Real-Time Continuous~     Glucose monitoring System (RT-CGMS)in measuring glucose in patients scheduled for surgery;~     before, during and after surgery.~   "
236150|NCT00464516|"~     The study is designed as a single-center, randomized, double-blind, placebo-controlled study~     in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will~     either receive estetrol or placebo during a 2 week treatment period.~      Several biological markers, such as a cellular growth marker and cell death markers, will be~     assessed in the tumor tissue and surrounding normal tissue before and after the treatment~     period. During the 2 week interval between diagnosis of breast cancer and surgical resection,~     no therapy for breast cancer is usually administered.~   "
236151|NCT00464503|"~     This study aims to investigate whether statines (rosuva- and pravastatin) induce tubular~     proteinuria.~   "
236152|NCT00464490|"~     Mechanical ventilation commonly is associated with patient agitation requiring sedation to~     alleviate discomfort and reduce excessive central respiratory drive. Upon recovery from acute~     respiratory failure, sedation is reduced to facilitate the withdrawal of ventilatory support.~     In some patients, abrupt reduction in sedation provokes severe agitation that causes~     catecholamine release resulting in severe hypertension, tachycardia and tachypnea. This~     requires increased sedation to bring hemodynamic and respiratory function under control.~      Dexmedetomidine is an alpha-2 receptor agonist with both sedative and analgesic properties~     that allows for the reduction in the anesthetic and analgesic requirements in the~     perioperative setting. In addition to its sedative effects, alpha-2 receptor stimulation in~     the central nervous system inhibits sympathetic activity and reduces plasma epinephrine and~     norepinephrine levels, thereby lowering both arterial blood pressure and heart rate. Because~     alpha-2 receptor stimulation does not cause respiratory depression, dexmedetomidine may~     facilitate the transition to unassisted breathing in profoundly agitated patients. The~     investigators will prospectively evaluate dexmedetomidine in 30 patients who could not be~     extubated because of agitation with hemodynamic instability and tachypnea.~      The purpose of this study is to test if a larger prospective randomized controlled pilot~     study can show that dexmedetomidine facilitates weaning and extubation in patients who have~     failed previous attempts because of agitation and hyperdynamic cardiopulmonary response.~   "
236153|NCT00464477|"~     The Division of Medical Genetics at the University of Mississippi Medical Center is~     recruiting parents of children with a pervasive developmental disorder (including autism,~     autistic spectrum disorder, PDD-NOS, Asperger syndrome, childhood disintegrative disorder,~     and Rett syndrome) to participate in a study to help determine potential causes of the~     increasing prevalence of these disorders. The study is being conducted using an anonymous~     on-line survey available to parents through a secure link.~      The study consists of approximately 90 questions about the affected child, siblings, parents,~     and grandparents, which will take roughly 10-15 minutes to complete. Several families will~     also be invited to participate in a phone interview. Both the survey and the phone interview~     are conducted using a self-designated code to protect anonymity and patient privacy. No~     identifying information such as name, date of birth, address, or phone number will be asked.~     Only questions regarding the year of birth of family members will be asked.~   "
236154|NCT00464464|"~     The purpose of this study is to evaluate the efficacy of a cognitive-behavioral treatment,~     that includes a caregiver-focused social support intervention, for depression in persons with~     Parkinson's disease.~      Individuals who are unable to travel to the study site, but are interested in participating~     and meet all other eligibility requirements, will be allowed to participate over the phone.~   "
236155|NCT00464451|"~     The purpose of the study is:~        1. To compare the efficacy of dexmedetomidine versus chloral hydrate as pediatric sedation~          agents for EEG studies. Efficacy will be determined by successful EEG study completion~          and by minimum degree of sedation induced patient agitation (SAS score).~        2. To compare the safety and adverse event profile of dexmedetomidine versus chloral~          hydrate during sedation of pediatric patients for EEG studies. Comparison will be based~          on variance of vital signs (HR, MAP, RR, O2SAT, ETCO2) from baseline during sedation as~          well as the frequency of adverse events during and following sedation.~        3. To compare quality of EEG recording obtained with dexmedetomidine or chloral hydrate and~          to those of non-sedated pediatric EEG studies. Quality will be determined by the degree~          of background beta-wave activity.~   "
236157|NCT00464425|"~     Postoperative ileus remains a significant medical problem after colorectal surgery that~     adversely influences patients' recovery and prolongs hospital stay. In fact, a substantial~     portion of the overall hospitalisation period after colorectal surgery is attributed to the~     time it takes for ileus to resolve. Although laparoscopic colorectal surgery has been proven~     to be associated with better short-term clinical outcomes including faster return of~     gastrointestinal function than open surgery, the duration of postoperative ileus in the~     laparoscopic arm is still reported to be as long as 4 days in most of the randomised trials.~     Additional measures are thus necessary to further enhance the gastrointestinal recovery after~     laparoscopic colorectal surgery in order to maximise its benefits, and acupuncture may be one~     of the options. Acupuncture is widely accepted in China as well as throughout the world as an~     effective treatment option for the management of postoperative nausea and vomiting and~     various functional gastrointestinal disorders. Its role in treating postoperative ileus,~     however, is less clear, and data from the Chinese as well as the Western literature are~     scarce. We therefore propose to carry out a prospective randomised sham-controlled pilot~     study to assess the efficacy of electroacupuncture in treating postoperative ileus after~     laparoscopic colorectal surgery. The acupoints relevant to the treatment of abdominal~     distension and constipation, including Zusanli (stomach meridian ST-36), Sanyinjiao (spleen~     meridian SP-6), Hegu (large intestine meridian LI-4), and Zhigou (triple energizer meridian~     TE-6) will be used.~   "
236158|NCT00464412|"~     The purpose of the study is to determine the effect of a short educational program on young~     women's knowledge and beliefs about osteoporosis. They hypothesis is that following the~     intervention women who receive the educational program will have greater knowledge and~     beliefs about osteoporosis.~   "
236159|NCT00464399|"~     To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in~     de novo renal transplant recipients by assessing rejection rate everolimus trough levels,~     other safety laboratory variables and adverse events.~   "
236160|NCT00464386|"~     The purpose of this study is to prospectively evaluate whether the addition of continuous~     glucose monitoring to point-of-care (POC) glucometer monitoring improves glucose control.~   "
236161|NCT00464373|"~     The aim of this randomized placebo-controlled study is to demonstrate the efficiency and~     safety of the injection of Botulinum Toxin Type A (200 Units) into the external urethral~     sphincter for the treatment of chronic prostatitis/chronic pelvic pain.~   "
236162|NCT00464347|"~     VERTACL will investigate whether a triple therapy, Avastin®, half fluence verteporfin~     photodynamic therapy (PDT), and triamcinolone acetonide-preservative free (TAC- PF), results~     in improved 12-month vision outcome compared to Avastin® alone in participants with~     neovascular AMD.~   "
236163|NCT00464334|"~     The purpose of this study is to test the safety, tolerability and the immune response to an~     investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).~   "
236164|NCT00464321|"~     This study will investigate whether GC1008, an antibody which neutralizes TGF-beta, is safe~     in treating patients with the disease called focal segmental glomerulosclerosis (FSGS). The~     highest dose without excessive side effects will be investigated. Tests will determine how~     long GC1008 is in the body and how it is excreted.~   "
236165|NCT00464308|"~     The primary objective of this study is to compare, the number of patients with heartburn and~     regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole~     20 mg or esomeprazole 40 mg.~   "
236166|NCT00464295|"~     In patients with unresectable/advanced Hepatocellular Carcinoma receiving Capecitabin, we~     anticipate that the proposed chemotherapy will have a delay in progression of the disease .~     It is also expected that proposed chemotherapy will have acceptable toxicity and Quality of~     life.~   "
236167|NCT00464282|"~     Objective: L-[3-18F]-α–methyltyrosine (FMT) is an amino-acid tracer for PET. We evaluated the~     diagnostic usefulness of 18F-FMT PET in non-small cell lung cancer (NSCLC) patients. Tumor~     uptake of 18F-FMT PET was compared with 18F-FDG PET and the correlation with L-type amino~     acid transporter 1 (LAT1) expression also investigated.~      Method: Fifty patients with NSCLC were enrolled in this study, and a pair of PET study with~     18F-FMT and 18F-FDG was performed. LAT1 expression and Ki-67 labeling index of the resected~     tumors were analyzed by immunohistochemical study.~   "
236168|NCT00464269|"~     This study will evaluate the efficacy and safety of Brivaracetam to support the submission~     file in the indication of adjunctive treatment in adolescents and adults with partial onset~     seizures.~   "
236169|NCT00464256|"~     The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus~     placebo on abstinence from tobacco use in cigarette smoker.~      The secondary objective is to evaluate the effects of rimonabant on craving and weight and on~     the clinical and biological safety and tolerability of rimonabant in a population of~     cigarette tobacco smokers during a 10-week treatment period.~   "
236170|NCT00464243|"~     The purpose of this study is to assess efficacy and safety of volinanserin in the population~     of patients complaining of sleep maintenance insomnia. The patients suffering from that~     condition frequently wake up during the night, their sleep is non restorative and they suffer~     from a significant distress or impairment in their daily activities consecutive to insomnia.~   "
236171|NCT00464230|"~     An estimated 1.6 million patients sustain a hip fracture every year, about half of these are~     intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for~     any patient, and the risk of disability, increased dependence and death is substantial. The~     main treatment options for displaced femoral neck fractures are internal fixation and~     arthroplasty. It is established that there are more complications and reoperations after~     internal fixation, but there is no consensus about which procedure that gives best functional~     results.~   "
236172|NCT00464217|"~     To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar~     protocol, decreasing the dose of Idarubicin to try to reduce the deaths in induction~   "
236173|NCT00464204|"~     The rapidity and the quality of fluid resuscitation in patients with severe sepsis are~     important factors for the prevention of secondary multi-organ failure. Vascular filling may~     also have an impact on tolerability of enteral nutrition. The earliness and quantity of~     calories provided by enteral nutrition may have an impact on morbidity and mortality. This~     study will asses the effects of volume expansion on hemodynamics and tolerability of enteral~     nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly~     safety data of the study.~   "
236174|NCT00464191|"~     Funding: An investigator-initiated trial funded by H. Lundbeck AS.~      Study design: Prospective, randomised, placebo-controlled parallel-group multicenter study.~      Aim: To investigate efficacy and side effects (especially mood switches) of escitalopram,a~     selective serotonin reuptake inhibitor, in the acute and maintenance treatment of bipolar~     depression.~      Hypotheses:~        1. Escitalopram, given in addition to mood stabilising medications, is significantly more~          efficacious, measured by response and remission rates than placebo in bipolar depression~          (the acute phase study).~        2. Continuation therapy with escitalopram gives significantly longer mean time to~          depressive relapse and fewer depressive relapses compared to placebo (the continuation~          study).~        3. The incidence of mood switching (defined as development of mixed episodes, mania, or~          hypomania according to DSM-IV criteria) do not differ significantly between escitalopram~          and placebo in either the acute or the continuation phases.~      Patients: In- and outpatients receiving care in the specialised psychiatric services of~     Western Norway. The population is intended to be representative of the patients treated for~     bipolar depression in ordinary specialist care. Patients must have a MADRS score of at least~     20 at baseline. Patients with ongoing substance abuse or dependence, organic mental illness,~     and non-affective psychotic symptoms are excluded.~      Medication: Escitalopram 10-20 mg daily or placebo in addition to mood stabilisers. The dose~     of mood stabilisers must have been constant for the last six weeks prior to randomisation.~      Method: Phase 1 is a eight-week acute treatment trial with six clinical assessments. Patients~     treated with escitalopram who have not responded after eight weeks (defined by at least 50%~     reduction of MADRS score compared to baseline) leave the study. Placebo non-responders are~     treated openly with escitalopram and repeat phase 1. Responders are re-randomised to 32 weeks~     of maintenance treatment (phase 2). Phase 2 has nine clinical assessments. Patients who~     develop hypomania, mania or depressive episodes (defined as episodes meeting DSM-IV criteria~     for Major Depressive Episode with MADRS scores of at least 20 points) leave the study in this~     phase. Patients leaving the study prematurely will be offered alternative treatment.~   "
236175|NCT00464178|"~     The purpose of this study is to determine whether the combination of bevacizumab and~     bortezomib have increased efficacy in the treatment of relapsed/ refractory multiple myeloma.~   "
236176|NCT00464165|"~     The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo~     on abstinence from tobacco use in cigarette smokers.~      The secondary objective is to evaluate the effects of rimonabant on craving and weight and on~     the clinical and biological safety and tolerability of rimonabant in a population of~     cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of~     abstinent subjects during a 40-week follow-up post treatment.~   "
236177|NCT00464139|"~     At the Leuven University Fertility Centre (LUFC) of the Department of Obstetrics and~     Gynecology of the University Hospitals Leuven, Belgium, a retrospective epidemiological~     prevalence study based on an electronic search of patient files was performed to determine~     the prevalence of histologically proven endometriosis in a subset of infertile women with a~     regular cycle (variation 21 - 35 days), a partner with normal sperm and no previous surgical~     diagnosis of endometriosis.~   "
236178|NCT00464126|"~     The purpose of the study is to help determine if either crystalloid solution or colloid~     solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac~     patients.~   "
236179|NCT00464113|"~     The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how~     often it should be taken, and how well people with leukemia tolerate XL228.~   "
236180|NCT00464100|"~     We believe that how a baby with Hypoplastic Left Heart Syndrome (HLHS)does after a major open~     heart operation, measured by things like blood pressure, oxygen saturation, heart rate and~     others, may have an impact on development. Studying how post-operative condition impacts~     outcomes may help us to protect babies better when they undergo surgery.~      This study will look at some of the long-term outcomes of children with HLHS, including both~     mental development and quality of life. We will use information from your child's medical~     record to see if early oxygen delivery has an impact on later development.~   "
236181|NCT00464087|"~     The primary objective of this clinical trial is to evaluate safety of switching from~     fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute~     coronary syndrome undergoing percutaneous coronary angioplasty.~   "
236182|NCT00464074|"~     This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in~     patients with relapsing forms of MS.~   "
236183|NCT00464061|"~     The purpose of this study is to assess efficacy and safety of volinanserin in the population~     of patients complaining of sleep maintenance insomnia. The objective of the substudy is to~     assess glycemic control in the subgroup of patients with type II diabetes mellitus.~   "
236184|NCT00464048|"~     We will evaluate the effect of a short-term aerobic exercise program as an adjuvant treatment~     in patients with depression undergoing standard clinical antidepressant medication therapy as~     compared to the effect of stretching exercise. In addition, the effect of exercise on plasma~     biological markers will be examined and observed changes correlated with clinical~     antidepressant effects. We hypothesize that the aerobic exercise group will achieve a~     significantly higher response rates of depressive symptoms, will also have a greater degree~     of change in the plasma markers, than the control stretching group.~   "
236185|NCT00464035|"~     The purpose of this study is to investigate the effect of calcium on postprandial lipid~     profile and appetite.~   "
236186|NCT00464022|"~     Double-balloon enteroscopy (DBE) is a novel endoscopic procedure for visualising the entire~     small bowel. In any GI endoscopy procedure it is mandatory to insufflate gas into the bowel~     to secure good visualisation. All endoscopes used for GI endoscopy provide a gas insufflation~     unit. Currently, air is used for this purpose in more than 90% of centres throughout the~     world. The use of air, however, is far from ideal to use for insufflation in GI endoscopy.~     After GI endoscopy, significant amounts of air are usually retained in the bowel segment~     inspected (5). This air has to pass the GI tract and exit physiologically through the rectum.~     Thus, abdominal pain and discomfort during and after the examination due to the retention of~     air has been shown to be very common during and after endoscopic procedures (5-9).~      Carbon dioxide gas (CO2), unlike air, is rapidly absorbed from the bowel. Within minutes,~     several litres of CO2 can be absorbed from the GI tract. The use of CO2 has been shown to~     result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in~     several randomised trials (6-9). In these studies, CO2 insufflation almost completely reduced~     procedure-related pain and discomfort.~      To our knowledge, no research has been performed investigating the use of CO2 in DBE. DBE is~     a long-lasting procedure (mean examination time 75 minutes (4)). Large volumes of air are~     insufflated during the procedure, leading to significant distension of the small bowel during~     and after the examination.~      One of the main technical difficulties in DBE is the formation of small bowel loops and scarp~     angels during deep intubation of the endoscope. These loops and angels are the major~     restriction to deep intubation of the endoscope. Loops and scarp angels are more pronounced~     in air-distended bowel segments.~      The aim of the present study is to examine whether CO2 insufflation leads to a reduction of~     abdominal pain in DBE patients. Furthermore, we want to investigate if CO2 insufflation~     facilities a deeper intubation of the endoscope and thus a more complete examination of the~     small bowel mucosa.~      The study is designed as a two-centre randomised controlled trial. Randomisation to the two~     treatment groups (CO2 or air insufflation) is performed on basis of the individual~     participant.~   "
236187|NCT00464009|"~     This study aimed to evaluate the effect of three forms of continuing medical education (CME)~     on provision of preventive dental services to Medicaid-enrolled children by medical personnel~     in primary care physician offices.~   "
236188|NCT00463996|"~     Can MRI be used to stage ovarian cancer?~   "
236512|NCT00459680|"~     To determine the effect of acupuncture and laser acupuncture point treatment on hypertensive~     subjects.~   "
236189|NCT00463983|"~     Octreotide is a somatostatin analog with a long half-life in vivo. Octreotide has interesting~     anti-inflammatory and anti-fibrotic properties in vitro and in vivo. Somatostatin receptors~     are increased and Octreotide uptake is increased in the lung in patients with idiopathic~     pulmonary fibrosis. Our hypothesis is that octreotide may slow the degradation of lung~     function in patients with IPF. In this proof of concept study, patients with IPF will receive~     an intramuscular injection of slow release octreotide (Sandostatin LP, 30 mg)every 4 weeks~     for 48 weeks. Lung function (FVC, DLCO), HRCT scores for fibrosis and ground glass, 6 minute~     walking test,quality of life and survival will be monitored.~   "
236190|NCT00463970|"~     CINS is a large multicentre study which aims to test out the effect of 4 different~     interventions, namely a brief cognitive intervention (BI), a more extensive cognitive~     behavioural intervention (CBT), and 2 different nutritional supplementations (seal oil and~     soy oil) in a population of chronic low back pain patients sicklisted for 2-10 months.~   "
236191|NCT00463957|"~     Sildenafil and similar drugs have been used for several years to treat erectile dysfunction.~     It has been noticed that in some people, sildenafil causes a subtle increase in the length of~     time that visual images that we see are retained by the retina. It is thought that this might~     be due to an effect of sildenafil on inhibiting an enzyme called phosphodiesterase type 6~     (PDE6) which is present in the retina. By giving single oral doses of sildenafil and a~     similar drug called tadalafil which has less effect on PDE6, we hypothesise that this is the~     mechanism of the change in vision caused by sildenafil. By performing computerised visual~     test, we plan to compare the effects of sildenafil, tadalafil and placebo tablets on vision~     in healthy volunteers.~   "
236192|NCT00463944|"~     A study of an electronic voting system as a learning aid during tutorials~   "
236193|NCT00463931|"~     Schistosomiasis and soil-transmitted helminhtiasis occur throughout the developing world and~     are most prevalent in the poorest communitites. These worms have been linked to several~     nutritional and intellectual deficiencies in many endemic populations worldwide. Helminth~     control, though crucial has been neglected for varied reasons. Currently, interests towards~     the control of neglected diseases including schistosomiasis and soil-transmitted helminths~     has been revived through many interventions including repeated chemotherapy to help improve~     public health outcomes and prevent long term morbidity. This will contribute to achieving~     several of the Millennium Development Goals at a favourable cost. A community-directed~     treatment of human schistosomiasis and STH in school-aged children in rural notrhern Ghana~     using praziquantel and albendazole is proposed. It is planned to test the hypothesis that~     community-based volunteers are non-inferior and more cost effective than rural school~     teachers at reaching school-aged children.~   "
236194|NCT00463918|"~     This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of~     two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at~     least three cigarettes per day.~   "
236195|NCT00463905|"~     Postmenopausal women with vertebral fractures (VFs) represent an important target for~     secondary fracture prevention, but few of these patients come for clinical attention. Recent~     evidence suggests that screening postmenopausal women for clinical risk factors like height~     loss and fracture risk identifies those at high risk of prevalent VFs who should be referred~     for diagnostic X-rays, a strategy which is likely to prove cost effective. However, before~     being applied at a United Kingdom (UK)-wide level, it needs to be established that use of~     this strategy improves secondary fracture prevention, and that these benefits are achieved in~     a cost-effective manner. To examine these questions, a randomised-controlled-trial will be~     performed in which women aged 65-80 from general practitioner (GP)-practices in the~     intervention group will be invited for risk factor assessment, followed by referral for~     thoracolumbar X-ray where appropriate. The primary outcome will be a change in bisphosphonate~     or other drug prescribing between the intervention and control arms after six months.~   "
236196|NCT00463892|"~     The study is designed to see if a high-resolution MRI scan of lymph node areas near where a~     melanoma has been removed from the skin can pick up the spread of melanoma to those lymph~     nodes with a high degree of accuracy.~   "
236197|NCT00463879|"~     The purpose of this study is to determine the acute effects of the nicotinic receptor~     allosteric modulator galantamine (0, 4 and 8 mg) on neurocognitive function in schizophrenic~     smokers (n=20) versus schizophrenic nonsmokers (n=10) in an outpatient human laboratory~     setting.~   "
236198|NCT00463866|"~     The purpose of this study is to evaluate the effect of two different maintenance doses of~     Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month~     treatment period~   "
236199|NCT00463853|"~     The purpose of this study is to determine whether it is safe to receive an injection of your~     own bone marrow adult stem cells (autologous BM-MNC) to your heart wall during coronary~     artery bypass graft (CABG).~   "
236200|NCT00463840|"~     The intention of this trial is to determine the maximum tolerated of the treatment~     combination and to evaluate its safety and efficacy.~   "
236201|NCT00463827|"~     Asthma is a chronic inflammatory condition of the lungs.~      There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with~     asthma do not respond as well to standard therapies as non-smokers.~      Statins are drugs which are already used to lower cholesterol. They have also been shown to~     have some anti-inflammatory properties.~      In this trial the investigators will give a randomised group of smokers Atorvastatin and the~     remaining group a placebo or blank tablet. The investigators will then monitor patients'~     responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.~   "
236202|NCT00463814|"~     The primary purpose of the study is to assess the safety, tolerability and pharmacokinetics~     of a capsule of AZD6244 in patients with advanced solid malignancies.~   "
236203|NCT00463801|"~     This study will evaluate the safety and efficacy of daptomycin against complicated skin and~     skin-structure infections in adults~   "
236204|NCT00463788|"~     The primary objective of this study is to determine whether overall response to cetuximab~     combined with cisplatin is better than overall response to cisplatin alone together with~     showing that the overall response for cetuximab and cisplatin was above a pre-specified~     threshold of 0.2 in the treatment of triple negative metastatic breast cancer.~      The secondary objective of this study is to compare the differences between the two treatment~     groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival~     (OS), Time to Response (TTR) and Safety.~   "
236207|NCT00463749|"~     Acetylcystein is a potent antioxidans which is able to prevent contrast dye induced~     nephropathy in stable patients undergoing additional hydration.~      In primary percutaneous intervention for infarction hydration is not possible. Therefore~     Acetylcystein might prevent contrast dye induced nephropathy.~      Furthermore, it might reduce infarct size as a result of its antioxidant properties.~      Clinical trials are missing so far examining the effects of Acetylcystein on nephropathy and~     infarct size.~   "
236208|NCT00463736|"~     Study compares the outcomes of women between 26 and 32 wks gestation with rupture of~     membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo~     of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups.~   "
236209|NCT00463723|"~     Background: Patients following allogeneic keratoplasty are treated with topical and~     frequently with systemic steroids to prevent immune reactions. Steroids are known to yield~     good results, but exert a wide range of side effects. The efficacy of topial FK506 in~     preventing immune reactions has already been demonstrated experimentally. FK506, an~     IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent~     than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be~     compared to our standard treatment (i.e. steroids) after penetrating normal-risk~     keratoplasty.~   "
236210|NCT00463710|"~     Phase IV open label, single-blind study, post-marketing, 1-year MRI observational study~     evaluating effect of Avonex® monotherapy (6.0 MIU administered i.m. each week) on the~     year-to-year changes in two annual measures—magnetization transfer imaging and~     diffusion-weighted imaging in patients with either relapsing-remitting (RR) or~     secondary-progressive (SP) multiple sclerosis (MS). One hundred fifty (150) patients with RR~     and SP MS—followed at the Jacobs Neurological Institute, University at Buffalo, Buffalo~     NY—who satisfy both inclusion and exclusion criteria will be included. They will be assessed~     at baseline and at 12 months with MRI and clinical examinations.~   "
236211|NCT00463697|"~     This study will involve the use of a new compound, GW642444 that is being developed for the~     treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on~     cells in the lungs, causing some of the muscles around the lungs to relax and open up better~     (bronchodilation), making breathing easier. When a medicine is made into a form ready to be~     given to patients, the active ingredient is often prepared with another ingredient called a~     salt to help make it stable, and inactive ingredients are often added. Inactive ingredients~     might be used to help a medicine work better, to make it easier to produce the medicine, or~     to make it easier to get an accurate dose of medicine. In previous studies the study drug has~     been given as a dry powder containing either the H salt (with the inactive ingredient~     lactose), or containing the M salt (with the inactive ingredients lactose and cellobiose~     octaacetate). The M salt form of the study drug has been altered to contain lactose and a~     new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).~      Participants in this study will receive both the H salt (GW642444H) and the new M salt~     (GW642444M) containing magnesium stearate. This study will be the first time the new M salt~     form of the study drug will be given to asthmatic patients.~   "
236212|NCT00463684|"~     Japanese encephalitis virus is the leading cause of viral neurological disease and disability~     in Asia. The severity of sequelae, together with the volume of cases, make JE the most~     important cause of viral encephalitis in the world. Approximately 3 billion people—including~     700 million children—live in areas at risk in Asia for JE. JE most commonly infects children~     between the ages of 1 and 15 years, and can also infect adults in areas where the virus is~     newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000~     to 15,000 deaths. This figure is believed to represent only a small proportion of the disease~     burden that actually exists.~      Data from a previous trial, also sponsored by PATH and conducted by investigators in the~     Philippines, indicate that there was no immunologic interference between Japanese~     encephalitis live attenuated SA 14-14-2 vaccine and measles vaccine when administered at the~     same time. Additionally, the safety profile of the coadministered vaccines was the same as~     for the vaccines administered separately. This research study, to be conducted among infants~     in Sri Lanka, is being done to confirm the Philippines trial results.~   "
236213|NCT00463671|"~     Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct~     therapy for diabetic wounds. However, some patients have insufficient increase or even~     paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was~     to investigate the pathophysiology responsible for the different consequences of HBOT and to~     evaluate the effect of N-acetylcysteine (NAC) on these changes.~      Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with~     non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the~     second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and~     plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide~     (NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete~     HBOT protocol.~   "
236214|NCT00463658|"~     With an aging population, an associated increase in the number of falls and fall injuries,~     there is a need to examine how health care services, such as home care, can best prevent~     falls among older people. This project will directly address this area by evaluating the~     effects and expense of an innovative approach to home care service delivery for older people~     at-risk for falls.~   "
236215|NCT00463645|"~     This is a mono-centre trial performed at the medical ICU at the Medical University Graz.~     There will be a study visit (V1) and a follow-up assessment (V2). In the study visit (V1)~     arterial blood glucose values will be monitored and subcutaneous sampling of interstitial~     fluid (ISF) with microdialysis for glucose determination and with microperfusion for~     cytokine-measurement will be performed. The study visit will last for 26 hours starting with~     the insertion of two catheters in the abdominal subcutaneous tissue (one microdialysis- and~     one microperfusion catheter). The primary hypothesis of the study is: Interstitial fluid~     glucose concentration profiles correlates to the arterial blood glucose concentration profile~     in patients with severe sepsis in the medical ICU.~   "
236216|NCT00463632|"~     Cross-sectional study of prevalence and intensity of schistosome infection in pregnant women,~     follow-up into postpartum, and the association of schistosome infection with haemoglobin~     concentration, compared to a group of non-pregnant women.~   "
236217|NCT00463619|"~     Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis~      Objectives:~      The objective of the study is to evaluate the follow up of patients treated with retarded~     release phosphatidylcholine in three controlled, randomized studies.~      Main question is to investigate whether treatment with phosphatidylcholine could spare~     patients the intake of steroids and immunosuppressants without clinical deterioration.~      Study population:~        -  Retarded release phosphatidylcholine in chronic-active ulcerative colitis.~        -  Retarded release phosphatidylcholine in steroid dependent ulcerative colitis.~        -  Dose finding study for retarded release phosphatidylcholine~      Outcome parameters:~      Definition of remission:~        1. SCCAI <2,5~        2. Likert scale: grade 1 or 2~        3. subjective impression of remission: yes/no~        4. no blood in stool~      Definition of relapse:~        1. subjective impression: yes/no~        2. SCCAI ≥ 5~        3. blood in stool~      Definition of low clinical activity: SCCAI < 5~      Primary endpoint:~      sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC.~      Secondary endpoints~        1. maintenance of continuous remission~        2. improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D)~          c.Likert Score~        3. relapse rate: a. time to first relapse b. clinical activity during relapses c. number of~          relapses in relation to length of treatment~   "
236218|NCT00463606|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin~     calcium combination therapy to monotherapy in subjects with dyslipidemia.~   "
236219|NCT00463593|"~     Current efforts to control schistosomiasis and soil-transmitted helminthes infections focus~     on the school-age population, and school-based treatment delivery programs offer a major cost~     advantages because of the use of the existing school infrastructure and the fact that~     schoolchildren are accessible through schools. However, in many developing countries, large~     numbers of school-age children are not in school and this has raised questions about the~     effectiveness of school-based programs in reaching non-enrolled children. Increasingly, the~     non-formal education sector is providing a growing solution to the problem of poor enrolment~     in basic education, especially in sub-Saharan Africa, and has recently been used to deliver~     praziquantel as part of a national schistosomiasis control program in Uganda. However, it is~     unclear how effective this program has been in reaching children who attend non-formal~     schools and whether the program has been reaching children from the poorest households.~   "
236220|NCT00463580|"~     Major depression is increasingly recognized to be a chronic and highly recurrent condition,~     which results in significantly increased health problems. One possible mechanism that may~     contribute to treatment resistance is increased production and release of chemicals called~     proinflammatory cytokines in patients with major depression. These chemicals mediate the~     body's response to infectious agents like bacteria and have been shown to be increased by~     psychological stress. They produce the symptoms that we associate with being sick, including~     fever, malaise and changes in sleep and appetite. Several lines of evidence indicate that~     proinflammatory cytokines may contribute to the development of major depression and may thus~     represent a novel target for the pharmacological treatment of the disorder.~      The TNF-alpha antagonist, Infliximab(Remicade®), is an infusion style drug approved by the~     FDA for the treatment of inflammatory conditions like Crohns disease and rheumatoid~     arthritis. We are conducting a study to see if the infliximab (Remicade®) is more effective~     than placebo in acutely reducing symptoms of depression in patients who have elevated~     proinflammatory markers and have not responded to, or been unable to tolerate, at least two~     previous treatments in the current depressive episode. Proinflammatory markers are measured~     by a simple blood test for C-Reactive Protein(CRP)levels in the body.~      After appropriate screening to determine eligibility, 64 subjects with treatment resistant~     depression will be randomized to receive three infusions of either infliximab(Remicade®)or~     placebo(salt water) in the Emory Infliximab Infusion Center in the Division of Digestive~     Diseases, Emory University School of Medicine. Subjects will be followed for 12 weeks with~     evaluations at weeks 0 (baseline), 1, 2, 3, 4, 6, 8, 10 and 12. The first~     infliximab(Remicade®)infusion will occur at the first (Baseline) visit. The second infusion~     will occur at Study Week 2 (the third visit). The third infusion will occur at Study Week 6~     (Visit 6). The choice of three infusions, and the infusion schedule, is based on current~     recommendations for the use of infliximab(Remicade®)in conditions for which it has received~     FDA approval. Subjects will be evaluated for twelve weeks by trained clinicians for changes~     in depression symptoms and improvements in quality of life. In addition, a physician will~     evaluate subjects each visit to make sure they are remaining healthy. Blood will be withdrawn~     at baseline prior to infusion and all subsequent visits to check labs for safety but also to~     evaluate potential relationships between changes in inflammatory activity and therapeutic~     response. After Study Week 12, participants will be monitored by phone, every 4 weeks during~     the 22-Week Post Study Follow-up Phase to assess physical and psychiatric symptoms in the~     period following the final infusion. At the baseline and Week 8 visits, subjects will be~     admitted to the Atlanta Clinical Translational Science Institute(ACTSI),a research unit in~     the Emory Hospital, for an extended evaluation. The purpose of coming to the ACTSI will be~     for researchers to evaluate whether treatment with infliximab improves endocrine function,~     inflammation, sleep and thinking abilities in people who are depressed. For all other visits~     (Week 1, 2, 4, 6, 10 and 12), participants will come for an office visit in the Winship~     Cancer Institute.~   "
236221|NCT00463567|"~     Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of~     indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into~     study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and~     tolerability of the selected indacaterol doses in patients with COPD~   "
236222|NCT00463554|"~     The primary objective of this study is to obtain clinical performance information on the~     GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) in women with stress~     urinary incontinence (SUI).~   "
236223|NCT00463541|"~     To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive~     bladder symptoms (urgency, with or without urge incontinence, usually with frequency and~     nocturia).~   "
236224|NCT00463528|"~     The purpose of this study is to examine the extent of schistosomasis infections in women and~     children, their daily activites that encumber contact with water and their knowledge and~     attitudes towards the prevention of schistosomiasis.~      The hypothesis that will be explored is that women and children spent more time with~     agricultural and household activities which bring them in contact with water and therefore~     give them an increased risk of being infected by schistosoma. Prevention and control of~     schistosomiasis has to be focusing on women and children.~   "
236225|NCT00463515|"~     The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based~     induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is~     possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3~     cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic~     progression of disease. The induction chemotherapy is then to be followed by~     chemo-radiotherapy.~   "
236226|NCT00463502|"~     Aim: To investigate the effects of metformin treatment on thyroid hormone metabolism in~     euthyroid patients with type 2 diabetes mellitus.~   "
236227|NCT00463489|"~     The primary objective of this trial is to evaluate the effect of the addition of a 2 year,~     centrally delivered individualized, telephone-based lifestyle intervention focusing on weight~     management to a mailed educational intervention on Disease Free Survival in post-menopausal~     women with early stage breast cancer (hormone receptor positive), BMI ≥24-<40 kg/m2, who are~     receiving standard letrozole adjuvant therapy.~   "
236228|NCT00463476|"~     Japanese encephalitis virus is the leading cause of viral neurological disease and disability~     in Asia. The severity of sequelae, together with the volume of cases, make JE the most~     important cause of viral encephalitis in the world. Approximately 3 billion people—including~     700 million children—live in areas at risk in Asia for JE. JE most commonly infects children~     between the ages of 1 and 15 years, and can also infect adults in areas where the virus is~     newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000~     to 15,000 deaths. This figure is believed to represent only a small proportion of the disease~     burden that actually exists.~      An inactivated JE vaccine is currently being used in Sri Lanka. It is given to children in 3~     doses, at 12 months of age, 13 months of age, and 2 years of age. A booster dose must also be~     given to children at 5 years of age. If Sri Lanka decides to replace the inactivated JE~     vaccine with the live attenuated JE vaccine, there will be many children who still need a 3rd~     or booster dose of the inactivated JE vaccine. This research study is being done to see if~     the live attenuated vaccine will work well to replace the inactivated JE vaccine and if it is~     safe in Sri Lankan children.~   "
236229|NCT00463463|"~     High-dose chemotherapy and autologous stem-cell transplantation have an established role in~     the treatment of aggressive Non-Hodgkin's lymphoma (NHL) when refractory to first line~     chemotherapy or after relapse. The PARMA study randomized 109 patients, with chemo-sensitive~     relapse and no marrow involvement to receive, following the initial salvage regimen,~     high-dose chemotherapy versus continuous standard dose chemotherapy. 5-year progression-free~     survival was 46% in the transplant group compared with 12% in the chemotherapy group. Results~     are significantly inferior in patients with multiply relapsed or chemo-refractory disease~     with only 0-20% of patients achieving long-term disease control with autologous~     transplantation. Thus a large proportion of patients with refractory and relapsing disease~     are not cured with currently available transplantation methods and newer approaches are~     required.~      Rituximab is the first monoclonal antibody approved for clinical use. It is an anti CD20~     antibody with high response rate in the treatment of follicular lymphoma and increases~     response rate in aggressive lymphoma when combined with chemotherapy. It is well tolerated~     with minimal side effects. However tumors may escape rituximab sensitivity by loss of~     antigen, poor access of antibody to bulky or poorly vascularized tumors, or failure of host~     effectors to eliminate antibody binding tumor cells. Lymphoma cells are inherently and~     exquisitely sensitive to radiation. Radioimmunotherapy uses monoclonal antibodies conjugated~     with a radioactive isotope to target radiation directly to tumor cells. Ibritumomab is the~     parent murine anti CD20 antibody witch targets the same epitope as rituximab. Tiuxetan is a~     chelator covalently linked to the antibody which chelates the isotope 90Yttrium to form the~     active radioconjugate Zevalin. 90Yttrium is a pure high-energy beta emitter with a relatively~     short half time (64 hours) and a path length of 5 mm. These properties make it an ideal~     isotope for radioimmmunotherapy. The high energy and long beta path are advantageous in~     treating bulky, poorly vascularized tumors, and tumors with heterogeneous antigen expression~     as neighboring tumor cells can be hit by cross fire from tumors binding the radioconjugate.~     Pure beta emission limits radiation to the patient body and is safe for the surrounding~     allowing simple outpatient care, no need for patient isolation or shielding. Biodistribution~     is predictable, eliminating the need for dosimetry. Initial studies showed that Zevalin has a~     favorable toxicity profile and is more effective than rituximab in patients with follicular~     and transformed non-Hodgkin's lymphoma, and studies are currently performed in aggressive~     lymphoma.~      There are initial phase I-II studies combining radioimmunotherapy with high-dose chemotherapy~     and autologous stem-cell transplantation with promising results. We conducted a phase II~     study of fixed-dose Zevalin at 0.4 mCi/kg with BEAM high-dose chemotherapy in patients with~     chemo-refractory disease. So far, 23 patients were included. With a median follow-up of 17~     months the estimated progression-free survival was 52% compared with 0-20% expected in~     patients with multiply relapsed and chemo-refractory disease. Based on these data and data~     from other groups we expect that the addition of Zevalin to standard high-dose chemotherapy~     will improve transplantation outcomes in patients with standard-risk chemosensitive disease,~     as well. This study will randomize patients to Zevalin-BEAM versus BEAM alone to determine~     the potential of Zevalin radioimmunotherapy to improve outcome of autologous stem-cell~     transplantation.~   "
236230|NCT00463450|"~     The typical menopausal symptoms that are associated with a variety of physical and~     psychological changes (e.g. nervousness, anxiety, and depression) and also with impaired~     sexual interest and enjoyment are caused by a lack of estrogen, a female sex hormone produced~     inside the body. To treat these symptoms, women who are postmenopausal can receive a therapy~     called 'hormone replacement therapy' (the dosage of hormones to replace the body's deficient~     hormones), for instance, with estrogen preparations injected into a muscle.In women with a~     uterus estrogen use causes the lining of the womb (endometrium) to grow (thicken) as before~     the menopause. With long-term use this may lead to pathological changes of the endometrium.~     That is why this therapy should be complemented by the estrogens' natural counterbalance,~     progesterone (progestogen), at a certain interval. This causes the lining of the womb to~     shed, with monthly bleeding like a normal period, thus avoiding excessive endometrial~     growth.Estrogen treatment is well known to relieve psychological complaints. The combination~     of an estrogen with a weak androgen (in this case Dehydroepiandrosterone (DHEA)) is presumed~     to clearly increase this effect. The present clinical study is to prove that Gynodian? Depot~     as a combination of estrogen and androgen has a better effect on psychological complaints and~     sexuality in postmenopausal women than has treatment with the estrogen Estradiol valerate~     alone.All patients will receive the same therapy, but differing in sequence. Either they~     receive Gynodian? Depot during the first five cycles and the estrogen-only preparation during~     cycles 6-10 (treatment group 1) or they receive the study medication in reverse order~     (treatment group 2). Patients will be assigned to one of the two groups at random. In either~     case they will be given an injection into the gluteal muscle every four weeks.Women with an~     intact uterus, in addition to the injections (the day of the injection being the 1st day of a~     cycle) have to take a tablet containing 5 mg Medroxyprogesterone acetate (MPA) (progestogen)~     per day for 14 days (cycle days 15-28) to enable the endometrium to shed in a monthly~     period.The study will extend over a total period of about 11 months, during which the patient~     will have 16 appointments for examinations.After patient has signed on the informed consent~     form for participation in this clinical study, the investigator will ask her, which diseases~     she has at the moment or has had during the past 12 months and which medicinal products she~     has been taking. Subsequently, she will have a gynecological examination (including the~     breasts) as well as a general physical examination. Blood pressure, heart rate as well as~     body height and weight will be measured and noted down. In addition, the doctor will question~     her about physical and psychological menopausal complaints by means of two different, short~     questionnaires. Only if the evaluation of these two questionnaires shows that she is eligible~     for the participation in this clinical study, will the following actions be carried~     through.Approx. 40 ml blood will be taken from the patient for a thorough laboratory test~     including her hormone levels, and she will be asked for a urine sample. Additionally, she~     will have a vaginal ultrasound examination of the womb lining, a cervical smear test (unless~     already done during the last three months), and an x-ray examination of the breasts~     (mammography) (unless already done during the last 12 months).These measures will be repeated~     at Final visit.About 3 weeks after visit 1, when the investigator has the results of all~     tests prescribed at visit 1, the patient will be asked to appear for visit 2.If the patient~     is eligible for a participation in this clinical study, she will be given the first injection~     of the study medication.During the following visits, injections will be given, blood pressure~     and pulse rate as well as body weight will be measured and blood will be drawn to measure the~     hormone levels.All procedures will apply also during the second treatment period. When~     switching to the second treatment period a physical and gynecological examination will~     additionally be performed.Questionnaires have to be filled in by the patient at different~     time points during the study.~   "
236324|NCT00462176|"~     This study is executed to evaluate the outcome on quality of life, pain, sexuality, pregnancy~     rate and recurrence rate after a fertility sparing multidisciplinary CO2 laser laparoscopic~     radical excision of deep infiltrating colorectal endometriosis with a bowel resection.~   "
237151|NCT00451139|"~     The purpose of the study is to evaluate the potential side-effects of artemether /~     lumefantrine and other antimalarials on the auditory function.~   "
236231|NCT00463437|"~     The purpose of this study is to assess the safety in terms of fever (rectal temperature)~     higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response~     following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of~     age in children previously primed with the same vaccines including a pneumococcal conjugate~     vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and~     meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus~     influenzae type b (Hib-MenC) vaccine.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00334334).~   "
236232|NCT00463424|"~     The main hypotheses for this study are as follows:~        1. The use of NeuFlex implant results in flexion in the fourth and fifth MP joints that is~          at least 10 degrees greater than with teh use of the Swanson implant.~        2. The use of the NeuFlex implant is associated with a significantly (2.5 kg or more)~          greater grip strength than with the use of the Swanson implant.~   "
236233|NCT00463411|"~     The aim of this study is to identify potential risk factors for fragility fractures in men.~   "
236234|NCT00463398|"~     From September 2006 a prospective cohort study is conducted among all patients operated at~     the Leuven University Fertility Centre to evaluate clinical and economical outcome after CO2~     laser laparoscopic fertility surgery.~   "
236235|NCT00463385|"~     The purpose of this study is to determine the safety of and to select a treatment regimen of~     pomalidomide (CC-4047) either as single-agent or in combination with prednisone to study~     further in patients with myelofibrosis with myeloid metaplasia (MMM).~   "
236236|NCT00463372|"~     To evaluate the safety and tolerability of multiple doses of PF-02545920 subjects with~     schizophrenia or schizo-affective disorder who are currently clinically stable and to~     evaluate the serum and urine pharmacokinetics of PF-02545920 and the N-desmethyl metabolite,~     PF-01001252, after multiple doses of PF-02545920 administered orally.~   "
236237|NCT00463359|"~     The purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas~     on the face removed with curettage and electrodessication (cautery) followed by application~     of Imiquimod cream to the base and further to achieve lower recurrence rates than after~     treatment with curettage and electrodessication alone.~   "
236238|NCT00463346|"~     The aim of this study is to evaluate the safety and efficacy of acamprosate for patients with~     alcohol dependence and comorbid schizophrenia spectrum disorders.~        -  1: Relative to placebo, acamprosate will significantly increase cumulative days of~          abstinence in recently detoxified alcohol dependent schizophrenia patients measured by~          Timeline Follow-Back (TLFB) method.~        -  2: Acamprosate will have no significant effect on the psychotic symptoms in~          schizophrenia patients with alcohol dependence as measured by the Positive and Negative~          Syndrome Scale (PANSS).~   "
236239|NCT00463333|"~     Summary:~      Postoperative delirium is a highly prevalent disease (10–30% prevalence) after surgery in~     intensive care unit, however, it is often misdiagnosed and mistreated. The aim of the present~     project is to investigate risk factors for postoperative delirium in more detail, to evaluate~     respective cognitive test systems and to measure EEG activity parallel to patients’ serum~     anticholinergic activity. The pathophysiology of delirium is unknown up to now: a possible~     dysbalance between cerebral acetylcholine and dopamine concentrations is a likely hypothesis.~     Therefore, the measurement of peripheral serum anticholinergic activity could be a new~     prognostic factor for evaluation of delirium. Because delirium is also associated with higher~     postoperative mortality and morbidity, with delayed functional recovery, and postoperative~     delirium makes patient management much more difficult, increases costs, and, above all,~     causes severe discomfort to the patient new interdisciplinary diagnostic strategies are~     necessary to resolve this problem.~   "
236240|NCT00463320|"~     This is a two-part study to evaluate the safety, tolerability and pharmacokinetics of single~     (Part A) and repeat (Part B) eye drop doses of pazopanib in healthy adult and elderly~     subjects.~   "
236241|NCT00463307|"~     The purpose of this study is to evaluate the use of a urine test strip in diagnose~     schistosoma mansoni in areas of Kenya where the rate of infections are low.~      The hypothesis is that the urine strip test is a superior tool to the conventional~     parasitological tools used to diagnose schistosomiasis mansoni infections in area where there~     is low transmission~   "
236242|NCT00463294|"~     I. Main Research Question:~        -  To compare the risks and benefits of Off-pump Coronary artery bypass surgery (CABG) to~          On-pump CABG and to determine if one is better than the other.~        -  The purpose of this pilot study is also to see the rate of recruitment with~          expertise-based randomization across different hospital settings.~      II. Small RCT studies and meta-analyses done so far have not been able to conclusively say~     which of the procedure is better. A large randomized study is required to establish the risks~     and benefits associated with both the off-pump and on-pump CABG surgical procedures.~      III. The study will look at which of the two techniques reduce major risks associated with~     CABG.~   "
236243|NCT00463281|"~     Aim of this study is to define a CT-based tissue window for stroke thrombolysis. Our~     primary hypothesis is that~        1. patients with a tissue window (favourable non-contrast CT (NCCT) scan and an~          intracranial occlusion on CT angiography (CTA) or perfusion-CT-mismatch (area of~          reduced cerebral blood flow (CBF) > area of reduced cerebral blood volume (CBV))~          represent a significant proportion (> 20%)of acute stroke patients and therefore are an~          important target group for future interventional studies~        2. patients with a tissue window suffer an unfavourable outcome (> 50 % mRS =>4 at 3~          months)if the occluded artery was not recanalized.~   "
236244|NCT00463268|"~     The purpose of this study is to evaluate the efficacy of the intermittent administration of~     alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for~     menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution~     treatment.~   "
236245|NCT00463255|"~     We investigate whether a change in diet could provide positive effects on general brain~     functions in healthy elderly people.~   "
236246|NCT00463242|"~     This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg~     per day and will compare agomelatine and paroxetine tolerability. Eligible patients will~     receive double-blind study medication for 8 weeks. One week after completion of the~     double-blind treatment phase there will be a single follow-up visit.~   "
236247|NCT00463229|"~     As the population ages and the number of stroke survivors increases, information is needed to~     determine the best way of providing home care services for rehabilitation to stroke survivors~     and their caregivers while containing health care costs. This project will address this area~     by developing and testing the effects and costs of a collaborative and specialized team~     approach to stroke rehabilitation by health professionals, in a home care setting, compared~     to usual home care services. The overall goal of this way of providing home care services is~     to improve the quality of life and function of stroke survivors and their caregivers and~     prevent future strokes, which will reduce the overall cost to the health care system.~   "
236248|NCT00463216|"~     The aim of the study is to investigate the possibility that a diagnostic evaluation by a~     multidisciplinary team reduces the length of sick leave.~   "
236249|NCT00463203|"~     Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The~     activity is limited, with an approximately 15 % response rate and a progression-free survival~     of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and~     the high-level expression of vascular endothelial growth factor on malignant gliomas, one~     would expect synergy between bevacizumab and irinotecan against gliomas.~      Recent data form a small study of 32 patients from Duke University have achieved a response~     rate of 62% in patients with malignant gliomas. Most included patients had glioblastomas, but~     this regimen may also have activity in more rare primary malignant brain tumors. The~     investigators therefore plan to include other primary malignant brain tumors in this study,~     and the clinical activity will be correlated with biomarkers and PET results of metabolic~     activity and blood flow. This may result in information that can be used to individualize~     therapy in the future.~   "
236250|NCT00463190|"~     Probiotic bacteria inhabit the gastrointestinal tracts of healthy individuals and may improve~     the health status of patients with digestive disease. The first aim of our study will seek to~     determine if probiotics medication (Bio-Three) inhibit gastrointestinal infection and reduce~     its inflammatory response in the intestine. The second aim will explore the bacterial count~     (microbiology) and subsequent immune response in probiotic inhibition of enterocolitis in~     children. We try to seek to gain an advanced understanding of probiotics versus pathogenic~     microorganism and host interactions, and mucosal immune responses to probiotics in the~     intestine.~   "
236251|NCT00463177|"~     Chronic, unexplained pain symptoms are very common in all layers of the population, but it is~     largely unknown what causes them. This study examines the hypothesis that patients with these~     pain symptoms process pain abnormally in their brain. TO this aim, we compare patients and~     healthy people: they receive mild pain at their painful body region and at another location.~     Concurrently, we measure brain activity with brain scans (functional MRI scans). With our~     study results, we want to increase understanding of what causes chronic, unexplained pain~     symptoms, in order to find better methods of diagnosing and treating them.~   "
236252|NCT00463164|"~     This study aims to investigate the role of fronto-striatal circuits and cognitive control in~     the perseverative and inflexible behavior that is a defining feature of autism. We~     hypothesize that deficits in the development of fronto-striatal circuitry may underlie~     cognitive inflexibility in autism. Specifically, we hypothesize that repetitive, inflexible~     behavior arises as (1) fronto-striatal systems are capable of learning patterns present in~     the environment (as in implicit learning paradigms), but are unable to adapt behavior to~     changing circumstances, related to either (2) decreased ability of basal ganglia to detect~     violations of expectancy, (3) decreased ability of prefrontal cortex to respond to detected~     violations, or (4) decreased connectivity of the circuits. We are conducting three functional~     Magnetic Resonance Imaging (fMRI) studies to address these hypotheses.~   "
236253|NCT00463151|"~     The purpose of this study is to examine the safety and efficacy of rebamipide by once daily~     intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with~     active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).~   "
236254|NCT00463138|"~     Researchers examined perceived satisfaction and perceived increase or decrease in symptoms~     among recipients of treatment at the Jerusalem Center for the Treatment of Psychotrauma,~     using self report methods. Researchers hypothesized that a significant number of recipients~     would report a decrease in their symptoms and general satisfaction with the treatment they~     received.~   "
236255|NCT00463125|"~     -  Systemic sclerosis (scleroderma; SSc) is a connective tissue disease characterized by a~          progressive fibrosis of the skin and visceral organs.~        -  A diffuse cutaneous microvascular damage occurs in 30-50% of patients, often leading to~          digital ulcers development, responsible for pain, functional disability, disfiguring~          scars, digital bony reabsorption, infection and osteomyelitis.~        -  Although the availability of drugs as i.v. prostacyclin analogs, oral vasodilating~          agents, oral phosphodiesterase-5 inhibitors, oral endothelin receptor blockers has~          improved the prognosis, digital ulcers are frequently refractory to the medical~          treatment.~        -  Preliminary data seems to demonstrate a pivotal role played by some growth factors~          (PDGF, TGF beta 1-2, IGF) in the process of ulcers healing: tissue regeneration and~          re-epithelization. Alpha-granules in the platelets store these factors in significant~          amount.~        -  Recently, the application of a gel rich in platelets, prepared from donors’ plasma taken~          by apheresis, seems to be beneficial to enhance pressure and vascular ulcers healing.~        -  On the basis of these considerations we expect that application of a platelet gel,~          combined with advanced dressing and conventional medical therapy, makes a more rapid~          healing of digital ulcers in patients with systemic sclerosis. We decided to conduct a~          double blind RCT to test this hypothesis~   "
236256|NCT00463112|"~     Studies on the effect of sibutramine, an anti-obesity drug, on hormonal and metabolic~     features of women with polycystic ovary syndrome (PCOS) are lacking.~      The objective of this study is to examine the effect of sibutramine plus hypocaloric diet on~     body composition, hormonal and metabolic parameters and insulin resistance in obese patients~     with PCOS.~      Overweight and obese women with PCOS were placed in a hypocaloric diet plus sibutramine (10~     mg/day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg/day) or~     hypocaloric diet only for the subsequent 6 months.~      The main outcome measures are: Body composition, hormonal and metabolic features and insulin~     sensitivity (OGTT) at baseline, at 3 and 6 months of treatment.~   "
236259|NCT00463073|"~     Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The~     activity is limited, with an approximately 15 % response rate and a progression-free survival~     of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and~     the high-level expression of vascular endothelial growth factor on malignant gliomas, one~     would expect synergy between bevacizumab and irinotecan against gliomas. In addition, 40-50 %~     of GBM have EGFR amplification/mutation making the EGFR an additional target. By combing~     cetuximab, with irinotecan and bevacizumab, one would expect further response, than~     irinotecan and bevacizumab alone. In addition, recurrent gliomas have an extremely poor~     prognosis, so innovative therapies are needed.~   "
236260|NCT00463060|"~     Cancer is the second leading cause of death in the United States, with approximately 90% of~     deaths resulting from patients with metastatic spread. Save for notable exceptions such as~     testicular cancer, chemotherapy alone cannot cure patients with metastases. Some patients~     with limited metastatic deposits (most commonly colon cancer spread to the liver) can be~     cured with surgery followed by chemotherapy. Therefore, some patients with metastases should~     be considered for aggressive local therapy (surgery and/or radiation).~      Even though chemotherapy has improved significantly, patients treated with conventional~     chemotherapy and/or biologically targeted therapy are not cured of their disease. For the~     most common types of cancer, chemotherapy alone can shrink or stabilize tumors for an average~     of 6 months before the tumors regrow. Both chemotherapy and biologically targeted therapy~     have major limitations preventing cure of these patients.~      Radiation therapy is an effective modality of treating cancer. Until recently, radiation for~     metastases was used only to relieve symptoms resulting from local tumor growth. Technological~     advances, including stereotactic radiotherapy, allow for radiation to be more precisely~     delivered to the tumor while sparing nearby normal organs. Stereotactic radiotherapy can~     completely eradicate local tumors with minimal side effects. Stereotactic radiotherapy has~     never been combined with drug therapy. Sutent is a new F.D.A. approved cancer therapy that~     targets tumor blood vessels. It is effective against two types of cancer that rarely respond~     to chemotherapy (GI stromal tumors and kidney cancer). We propose combining biologically~     targeted drug therapy with physically targeted stereotactic radiotherapy. Our goal is to~     determine if this is a safe regimen and the best method of combining these treatments.~     Ultimately, our goal is to cure some patients with previously incurable metastatic cancer~     with this combination.~   "
236261|NCT00463047|"~     Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate~     release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic~     pain.~   "
236262|NCT00463034|"~     RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with~     cancer may help doctors learn more about changes that occur in DNA and help doctors~     understand how patients respond to treatment.~      PURPOSE: This clinical trial is assessing how changes in genes affect disease progression in~     women with newly diagnosed or metastatic breast cancer.~   "
236263|NCT00463021|"~     Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol~     (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the~     treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.~   "
236264|NCT00463008|"~     RATIONALE: Collecting fluid from a brain tumor using a small catheter may help doctors learn~     how much methotrexate gets into the tumor to kill the tumor cells. It may also help doctors~     learn how methotrexate works in the brain and in the rest of the body.~      PURPOSE: This clinical trial is studying how much methotrexate gets into the brain tumor by~     collecting fluid directly from the tumor through a small catheter in patients undergoing~     stereotactic biopsy for recurrent high-grade glioma.~   "
236265|NCT00462995|"~     2.5 Rationale for preoperative erlotinib therapy~      Erlotinib is the only EFGR tyrosine kinase inhibitor to demonstrate a survival advantage and~     symptom improvement in a large phase III trial after failure of chemotherapy in advanced~     non-small cell lung cancer (Shepherd, Rodrigues Pereira et al. 2005). Although the potential~     utility of erlotinib in earlier stage NSCLC is unclear, given its activity in advanced~     disease and its minimal toxicity profile, there is likely a subset of patients who may~     benefit and potentially be cured by adjuvant erlotinib therapy. Erlotinib may also have~     greater antitumour activity in earlier stage disease. Therefore, we propose a phase II study~     to assess erlotinib pre-operatively in clinical stage 1 and 2 NSCLC, and downstream effects~     on signal transduction pathways and possible markers of treatment resistance and sensitivity.~      The proposed study involves administering oral erlotinib for four weeks (28 days)~     preoperatively in early stage (1A/B, 2A/B) NSCLC. Current waiting times for surgical~     resection of early stage NSCLC at UHN ranges from 4 to 6 weeks (Hui, Johnston et al. 2004),~     thus patients would not experience significant delay in time to surgery through this trial~     design. This study provides the opportunity to explore the impact of erlotinib on early stage~     NSCLC in humans, with pharmacodynamic assessment expected in 100% of patients post-treatment,~     in addition to correlative imaging. This study will evaluate the feasibility of preoperative~     therapy with erlotinib, and may facilitate the identification of predictive markers for~     response to erlotinib in early stage NSCLC. This may help further define the subset of~     patients who would benefit from adjuvant EGFR tyrosine kinase inhibitors, and those who may~     require other adjuvant approaches including chemotherapy and further clinical trials.~   "
236266|NCT00462982|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     brain metastases caused by kidney cancer or melanoma.~   "
236267|NCT00462969|"~     The purpose of this study is to learn fluid from sonohysterography can be used to diagnose~     endometrial cancer.~   "
236268|NCT00462956|"~     This study is designed to evaluate the efficacy and safety of GW572016 in patients with~     refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must~     have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2~     overexpressing tumors. Patients eligible for this study must have advanced metastatic breast~     cancer who have previously received treatment with anthracycline and taxane.~   "
236269|NCT00462943|"~     A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment~     of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.~   "
236270|NCT00462917|"~     The purpose of this study is to provide healthy adults with genetic testing and information~     about their chances of developing Alzheimer's disease.~   "
236358|NCT00461708|"~     This single arm study will evaluate the relationship between the skin toxicity of Tarceva in~     combination with gemcitabine, and survival, in patients with advanced and/or metastatic~     pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will~     be administered 100mg po per day. The anticipated time on study treatment is until disease~     progression, and the target sample size is 100-500 individuals.~   "
236271|NCT00462904|"~     The purpose of this study is to evaluate the safety of a protein called BPI that is naturally~     made by the body's white blood cells to fight infection. This study will initially evaluate~     an FDA approved investigational dosage and will measure the blood levels over time while BPI~     is being infused through a vein to see if the dose is potentially enough to obtain the~     desired effect. The drug will be started within 8 hours of burn injury and continued for 48~     hours. Patients will be followed on admission and through infusion in the Burn ICU where they~     will be monitored by ICU standards. They will be seen regularly thereafter on post-burn days~     1, 2, 3, 4, 7, 14 and 28 days while in the hospital. If the patient is discharged prior to~     the 28 day evaluation, they will be evaluated on or around the 28th day in the burn clinic. A~     blood sample will be obtained to look for potential genetic markers that may increase a burn~     patients' risk to develop infection in the post burn period.~   "
236272|NCT00462891|"~     RATIONALE: Screening may help doctors find breast cancer cells early and plan better~     treatment for breast cancer. The Mammography FastTrack program may be effective in increasing~     the number of patients who undergo mammography.~      PURPOSE: This randomized clinical trial is studying the use of a Mammography FastTrack~     program to increase the number of women who undergo mammography.~   "
236273|NCT00462878|"~     Observational study to compare the treatment in neutropenic patients after allogenic blood~     stem cell transplantation, with meropenem or meropenem plus glycopeptide.~   "
236274|NCT00462865|"~     Women with breast cancer who are not eligible for breast conserving surgery or who have~     node-involvement are sometimes treated with chemotherapy up front, in hopes of allowing for a~     woman to keep her breast and decreasing the size of the excision for her breast cancer. While~     current research has shown that survival is the same whether women are treated with~     chemotherapy first or surgery first for breast cancer, the investigators do not yet know how~     to treat women with persistent breast cancer after she has received primary chemotherapy.~     This study looks at the use of a combination regimen of two agents (gemcitabine and~     capecitabine), both of which are active in breast cancer, and using Avastin to see if this~     regimen can be given to women treated with primary chemotherapy and then surgery, considered~     to be at high risk of relapse.~   "
236275|NCT00462852|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients~     being treated with gemcitabine for pancreatic cancer.~      PURPOSE: This randomized phase II trial is studying how well gemcitabine works with or~     without dalteparin in treating patients with locally advanced or metastatic pancreatic~     cancer.~   "
236276|NCT00462839|"~     Post-partum hemorrhage (PPH) is defined as blood loss greater than 500 mL after vaginal~     delivery. Delayed diagnosis of PPH is a major cause of maternal morbidity and mortality.~     Obstetricians estimate blood loss at delivery by visual estimation of blood collected in the~     obstetric drapes. Blood is often mixed with urine and surgical sponges. The urine, blood, and~     sponges collect in a cone shaped plastic bag that is suspended from the perineum during~     delivery. Visual estimation of blood loss is insensitive in diagnosing PPH. In one study~     visual assessment of blood loss underestimated postpartum blood loss by 33% to 50% compared~     to an objective measurement of blood loss using photospectrometry. Other studies have shown~     that the magnitude of underestimation increases as the amount of blood loss is increased. A~     limitation of previous studies is that there is no gold standard for blood loss~     determination in the third stage of labor. Care providers (obstetricians, anesthesiologists,~     and labor & delivery nurses) need to be able to accurately estimate blood loss in order to~     better care for mothers and prevent morbidity and mortality. It is unknown whether provider~     type or experience (obstetric and anesthesiology resident, fellow, attending physicians, and~     nurses) influences the accuracy of blood loss estimation, or whether blood loss estimation~     can be improved by providing graduated markings on the vaginal delivery drape.~   "
236277|NCT00462826|"~     This phase II trial is studying the side effects and how well VEGF Trap works in treating~     patients with recurrent or persistent endometrial cancer. VEGF Trap may stop the growth of~     endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing~     substances directly to endometrial cancer cells.~   "
236278|NCT00462813|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of diindolylmethane, a substance found in cruciferous vegetables, may keep cervical~     intraepithelial neoplasia or cervical cancer from forming.~      PURPOSE: This randomized phase III trial is studying diindolylmethane to see how well it~     works compared to a placebo in treating patients with abnormal cervical cells.~   "
236279|NCT00462787|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine, topotecan, vinorelbine, thiotepa,~     and dexamethasone, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when~     given together with topotecan, vinorelbine, thiotepa, and dexamethasone in treating young~     patients with relapsed or refractory acute leukemia.~   "
236280|NCT00462774|"~     Cell transplantation for treatment of heart failure is a novel field of translational~     research that offers the perspective of developing curative approaches by regenerating or~     rejuvenating lost and/or diseased myocardium and inducing growth of new blood vessels.~     Based on the safety and preliminary efficacy testing in previous trials, a stringent efficacy~     testing will be performed in this study. Sixty patients who had myocardial infarction in the~     past and now need bypass surgery for ongoing coronary artery disease will undergo either~     bypass surgery and placebo treatment or bypass surgery and injection of CD133 bone marrow~     cells directly in the heart muscle. The study will be fully blinded, i.e. neither the patient~     nor the surgeon knows what substance is injected (placebo or cell product). Patients will be~     followed for 6 months and various heart function measurements will be performed.~   "
236281|NCT00462761|"~     Patients will receive oral AC220 daily for 14 days to study the side effects, tolerability~     and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3~     status.~   "
236419|NCT00460902|"~     Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of~     medication resistant major depression. Stimulation is administered with and without~     cognitive-emotional provocation.~   "
236283|NCT00462735|"~     For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences~     and for many patients, improves survival. While combined cisplatin and radiation or cetuximab~     and radiation is more effective than radiation alone, approximately 50% of these patients~     will still recur. A more aggressive approach may be needed for these patients to prevent~     recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given~     twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of~     patients are cured with this strategy. While cure rates are higher than standard chemotherapy~     and radiation and the treatment is tolerable, side effects during treatment are common. We~     propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab.~     Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.~   "
236284|NCT00462722|"~     The purpose of this study is to determine if the use of ibuprofen blocks the benefits of~     exercise to build bone and muscle mass.~   "
236285|NCT00462709|"~     The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf~     for the prevention of acute HAE attacks.~   "
236286|NCT00462696|"~     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in~     learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan~     better treatment. Drugs used in chemotherapy, such as epirubicin and docetaxel, may stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~      PURPOSE: This clinical trial is studying MRI in evaluating early response to chemotherapy in~     women receiving chemotherapy for infiltrating breast cancer.~   "
236287|NCT00462683|"~     The purpose of the study is to evaluate the state of bone health of brain injury patients~     being seen within a rehabilitation setting. Osteopenia is a condition of bone in which~     decreased calcification, decreased density, or reduced mass occurs. Osteoporosis is a disease~     in which the bones become extremely porous, are subject to fracture, and heal slowly. More~     specifically, the prevalence of osteopenia and osteoporosis at specific anatomic locations~     (e.g., forearms, hips, spine) will be determined as will specific interventions (e.g., use of~     vitamins, nutritional supplements, specific prescription medications) that people with brain~     injury may be applying, or have applied, to manage their bone health. An attempt will also be~     made to evaluate severity of brain injury, based on loss of muscle strength/function, and to~     compare this data with bone-focused information such as bone mineral density (BMD), falls,~     and history.~   "
236288|NCT00462670|"~     To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg~     or placebo in congestive heart failure (CHF) patients with extracellular volume expansion~     despite the use of a conventional diuretic.~   "
236289|NCT00462657|"~     RATIONALE: Studying ways to diagnose fungal infections early may help doctors plan the best~     treatment.~      PURPOSE: This clinical trial is studying laboratory tests to see how well they find~     aspergillosis early in patients at high risk of fungal infection caused by treatment for~     hematologic cancer or other disease.~   "
236290|NCT00462644|"~     Trauma patients are at increased risk for adrenal function insufficiency. A commonly used~     agent for rapid sequence intubation (RSI) is known to decrease adrenal function. We want to~     determine the incidence of adrenocortical insufficiency and its significance during the first~     24 hours of resuscitation following RSI in trauma patients.~   "
236291|NCT00462631|"~     The aim of the study is to compare the efficacy of Paclitaxel-eluting PTCA-balloon dilation~     (SeQuentTM Please) followed by cobalt-chromium stent (CoroflexTM Blue) deployment versus~     Paclitaxel-eluting stent (TaxusTM LibertéTM) deployment in the treatment of de-novo-stenoses~     in native coronary arteries (reference diameter:more then 2.5 mm and below 3.5 mm, length of~     stenosis ≥ 10 mm ≤ 20 mm) of patients with diabetes mellitus for ≥ 3 years for procedural~     success and preservation of vessel patency.~      This study is a prospective, randomized, multi-center, two-armed phase-II pilot study~     conducted in Malaysia and Thailand.~      128 diabetes mellitus patients shall complete the study per protocol after random assignment~     to either of the treatment groups on the order of 20 to 50 patients per center.~      Diabetes mellitus patients with stable or selected forms of unstable angina or documented~     ischemia due to a de-novo stenosis in a native coronary artery will be enrolled. Vessels may~     not supply an entirely infarcted myocardial area.~      Late lumen loss at 9 months is the primary endpoint.~   "
236292|NCT00462618|"~     The purpose of this pilot study is to assess feasibility and patient accessibility in order~     to design an adequately powered study to compare group cognitive behavioral therapy for~     insomnia (CBT-I) to quetiapine in non-demented patients aged 60 years or older with~     controlled bipolar disorder (I or II) or major depressive disorder who suffer from residual~     insomnia.~   "
236293|NCT00462605|"~     This phase II trial is studying how well giving MS-275 together with GM-CSF works in treating~     patients with myelodysplastic syndrome and/or relapsed or refractory acute myeloid leukemia.~     MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the cancer. Colony-stimulating factors, such as GM-CSF,~     may increase the number of immune cells found in bone marrow or peripheral blood. Giving~     MS-275 together with GM-CSF may be an effective treatment for myelodysplastic syndrome and~     acute myeloid leukemia~   "
236294|NCT00462592|"~     The purpose of this study is to compare the effects of 2 weeks therapy of montelukast,~     budesonide, their combination on exercise induced bronchoconstriction (EIB) and airway~     inflammation in children and young adults, not on regular controller therapy.~      Inhaled corticosteroids (ICS) are potent anti-inflammatory agents, which are effective in~     controlling and improving all aspects of asthma including the attenuation of EIB. However,~     the effect of ICS monotherapy on EIB is comparable if not inferior to the effect of CysLTs~     modifiers alone. This may be due to the lack of effect of ICS on the CysLT pathway. As a~     consequence, the investigators hypothesize that the combination of ICS and CysLT modifiers~     will offer a greater protection against EIB than either therapy alone. The different classes~     of drugs may act on complementary pathways believed to be important in the pathophysiology of~     EIB.~   "
236420|NCT00460889|"~     This study is designed to look at outcomes of patients who have undergone hand assisted~     laparoscopic donor nephrectomy versus totally laparoscopic donor nephrectomy.~   "
236295|NCT00462579|"~     It has been demonstrated that panresistant strains of Acinetobacter species may be selected~     by antibiotic use [4], may be transmitted from person to person [5], and may be passed via~     environmental contamination [6]. Surveillance for panresistant Acinetobacter species should~     be a priority, given the lack of antibiotic options for the treatment of these infections.~     There are currently no data on the antibiotic susceptibility of Acinetobacter species or on~     the rates of panresistant organisms. The elucidation of potential risk factors for resistant~     strains of Acinetobacter is therefore an important task, and the use of alternative~     antibiotics should be considered in ICUs where these strains are endemic.~   "
236296|NCT00462566|"~     The objective is to determine if motor cortex stimulation works for the following conditions:~        1. Deafferentation facial pain,~        2. Upper extremity complex regional pain syndrome (CRPS) and~        3. Brachial plexus avulsion or phantom limb pain.~      Each of these groups of 6 patients (total of 18) will be studied independently and all~     patients will be implanted with a motor cortex stimulation system. They will be randomised to~     either a regular or low stimulation setting in the two arms of the study. Each arm will last~     3 months.~   "
236297|NCT00462553|"~     This phase I trial is studying the side effects and best dose of sunitinib and gemcitabine in~     treating patients with pancreatic cancer or other solid tumors. Sunitinib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the tumor. Drugs used in hemotherapy, such as gemcitabine, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving sunitinib together with gemcitabine may kill more tumor cells.~   "
236298|NCT00462540|"~     The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation~     Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose~     inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare~     the preference/compliance of BID nebulization to QID use of MDI~   "
236299|NCT00462527|"~     Acute renal failure (ARF) is a rare but serious complication of gastroenteritis and~     dehydration, the most common reason for pediatric emergency visits. Renal function is~     determined by the glomerular filtration rate (GFR). Serum creatinine, the current marker of~     GFR, is insensitive and a late marker of ARF. Unfortunately, gold standard methods for~     measurement of GFR are impractical in the emergency setting. Recently, cystatin C (CysC) was~     introduced as superior marker for the measurement of GFR, particularly in children. A single~     random blood sample allows for accurate determination of GFR in the so-called~     creatinine-blind range and independent of the body composition. There is growing evidence~     that the determination of serum CysC concentration can detect ARF in adults earlier than~     serum creatinine or urinary fractional sodium excretion. No studies have examined this marker~     for the early detection of ARF in children at risk. We therefore propose a prospective study~     that compares CysC with other biomarkers of renal dysfunction for the early detection of ARF~     in children with dehydration due to gastroenteritis. Patients with minor trauma and a minimal~     likelihood of ARF will serve as a control. This study may establish CysC as an accurate and~     cost-effective marker for identifying patients at risk.~   "
236300|NCT00462501|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab~     may also stop the growth of rectal cancer by blocking blood flow to the tumor. Radiation~     therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and~     bevacizumab together with radiation therapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This clinical trial is studying how well giving combination chemotherapy and~     bevacizumab with or without radiation therapy works in treating patients with locally~     advanced rectal cancer~   "
236301|NCT00462488|"~     The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when~     administered as a monotherapy intravesical instillation in patients with non-invasive~     urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin~     (BCG).~   "
236302|NCT00462475|"~     Adult patients with hypopituitarism under adequate conventional hormone replacement therapy~     have reduced life expectancy due to excess vascular events (1-4). Deficiency in GH secretion~     (GHD) is likely to play a major role in determining the excess mortality, since it is~     associated with lipid abnormalities, visceral adiposity, glucose intolerance, insulin~     resistance, hypertension, cardiac abnormalities and increased intima-media thickness (IMT) at~     major arteries (5).~      Beneficial effects of growth hormone (GH) replacement on cardiovascular risk factors have~     been demonstrated in several studies of hypopituitary GHD patients (5). GH replacement~     improves body composition and lipid profile (5): it is accepted that management of~     dyslipidaemia is crucial in primary and secondary prevention of cardiovascular disease and~     part of the excess vascular risk associated with hypopituitarism is likely to be due to~     dyslipidaemia (6). A meta-analysis of blinded, randomized, placebo-controlled trials with low~     doses and long-duration GH treatment showed that GH replacement has beneficial effects on~     cardiovascular risk by improving lean and fat body mass, total and LDL cholesterol levels,~     and diastolic blood pressure (7). Besides, GH replacement also induces improvement in~     cardiovascular markers (8), and cardiac performance (9). In small cohorts of GHD adults,~     beneficial effects of GH replacement for 6-24 mos have also been reported on surrogate~     parameters of atherosclerosis, such as intima-media thickness (IMT) at major arteries~     (10-13), while 6 months of GH deprivation is associated with an impairment of the~     cardiovascular risk profile (12). In a consistent series of men and women with~     hypopituitarism we reported, however, that two years of GH replacement is not adequate to~     normalize IMT levels at common carotid arteries (13).~      To give further insights on the likelihood of reversal of early atherosclerosis in severe GHD~     patients after prolonged GH replacement, we designed this 5-yr prospective, controlled study.~     Only men aged ≤50 yrs and with severe GHD were enrolled to avoid gender and aging~     interference (13). Main outcome measure was IMT at common carotid arteries; secondary measure~     was prevalence of insulin-resistance syndrome according with the American College of~     Endocrinology (14).~   "
236303|NCT00462462|"~     Absolute ethanol has been used off-label as an unmodified formulation (solution) in~     Congenital Venous Malformations (CVM). Despite its effectiveness, absolute ethanol appears~     difficult to handle because of its high diffusion capacity outside the CVM and in the blood~     circulation. A less diffusible ethanol-based product (ethanol gel) has been developed in~     order to minimize systemic and local diffusion capacities of ethanol. Therefore, the~     pharmacokinetic parameters and their clinical and paraclinical outcomes between ethanol gel~     96% and absolute ethanol need to be carried out.~      FDA Office of Orphan Products Development (FDA OOPD) : Funding source.~   "
236421|NCT00460876|"~     This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of~     periocular topotecan in patients with relapsed-resistant retinoblastoma.~   "
236304|NCT00462449|"~     FES is a form of treatment with a device to aid movement in people who have had damage to~     their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves~     that supply paralyzed muscles. This activates those muscles, enabling them to produce basic~     but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the~     nerve that supplies the muscle and are connected by wires to a stimulator that produces the~     impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to~     the brain or spinal cord.~      Repetitive task practice is an activity-based therapy program that has been shown to~     enhance the recovery of hand and arm functions after stroke. This therapy consists of a set~     of training activities that are designed by a qualified therapist specific to your functional~     abilities that are to be performed with the impaired hand. These activities are designed to~     stimulate functional improvement with repetitive practice.~      Spasticity is a nervous system disorder where certain muscles are continuously contracted.~     Botox injections are commonly used to help to reduce spasticity in areas of the body with~     increased muscle tone. This research is designed to look at any additional benefit that may~     occur when Botox injections are combined with specific occupational therapy exercises and~     with a device that uses functional electrical stimulation (FES) to help improve muscle~     function after stroke.~   "
236305|NCT00462436|"~     Background: Treatment targets for cardiac risk factor reduction are not being met. Therefore,~     there is a need for new strategies to assist patients in meeting these goals.~      Objective: To determine the amount of any additional benefit on risk factor reduction~     associated with the consumption of the dietary portfolio (a low fat diet with soy, nuts and~     viscous fibres), above that achieved with medical management in diabetic patients following~     cardiac surgery.~      Description: 35 cardiac surgery patients with diabetes will be instructed on how to~     incorporate the dietary portfolio foods into their diet for four weeks. Changes in blood~     cholesterol, markers of inflammation, blood sugar control and modifiable risk factors will be~     assessed after 2 and 4 weeks of therapy.~      Relevance: Maximizing cardiac risk factor reduction through a combined approach (dietary plus~     medication) should improve outcomes, reduce rates of re-hospitalization and improve quality~     of life in diabetic patients after heart surgery.~   "
236306|NCT00462423|"~     The study is an open-label, single arm multicenter Phase II study to evaluate the safety and~     efficacy of the combination of Abraxane and Avastin as first-line therapy for patients with~     unresectable metastatic malignant melanoma. The patient sample will be approximately 50~     individuals, males and females 18 years of age or older with measurable metastatic melanoma.~      Patients will be treated with Abraxane administered weekly for 3 weeks via a 30-minute IV~     infusion at150 mg/m2 followed by 1 week rest (28-day cycle). Avastin will be administered in~     a dose of 10 mg/kg every 2 weeks (without rest period). Patients will be evaluated for~     disease progression every 2 months and those who do not have disease progression or~     unacceptable toxicity will be offered ongoing therapy until they have progressive disease or~     unacceptable toxicity.~   "
236307|NCT00462410|"~     RATIONALE: Measuring how advertising affects treatment compliance in women with breast cancer~     may help doctors plan the best treatment.~      PURPOSE: This clinical trial is studying how advertisements affect treatment compliance in~     women with breast cancer.~   "
236308|NCT00462397|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving combination chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin~     followed by cisplatin and radiation therapy works in treating patients with stage IB, stage~     II, stage III, or stage IVA cervical cancer.~   "
236309|NCT00462384|"~     This single arm study will assess the efficacy and safety of subcutaneous Mircera for~     correction of anemia in participants with chronic kidney disease who are not on dialysis and~     are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will~     receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting~     dose of 1.2 micrograms/kilogram [mcg/kg]). The anticipated time on study treatment is 3-12~     months, and the target sample size is 100-500 individuals.~   "
236310|NCT00462371|"~     Comparison between insulin pump treatment and multiple daily insulin injections in 38~     children with type 1 diabetes4-16 years old. Outcome metabolic control, quality of life,~     impact of disease and cost effectiveness.~      We hypothesised that insulin pump treatment would give a better metabolic control and quality~     of life.~   "
236311|NCT00462358|"~     This is a Phase 1 study during which patients with advanced solid tumors will receive~     investigational study drug ARRY-520.~      This study has two parts. In the first part, patients with advanced solid tumors will receive~     increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF)~     support, in order to achieve the highest dose possible that will not cause unacceptable side~     effects. Approximately 15 patients (per schedule) from the US will be enrolled in Part 1~     (Completed).~      In the second part of the study, patients will receive the best dose of study drug determined~     from the first part of the study and will be followed to evaluate what side effects the study~     drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15~     patients from the US will be enrolled in Part 2 (Completed).~   "
236312|NCT00462345|"~     This single arm study will evaluate the efficacy and safety of MabThera in combination with~     methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one~     or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and~     methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v.~     prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The~     anticipated time on study treatment is 3-12 months, and the target sample size is <100~     individuals.~   "
236325|NCT00462150|"~     The purpose of the study is threefold: 1) to develop a home-based emotional disclosure~     intervention inducing core elements of change (emotional engagement, cognitive restructuring,~     and positive future directedness); 2) to examine in a randomized controlled trial in patients~     with rheumatoid arthritis the induction of the core elements and the feasibility of the~     intervention for home application; and, 3) to examine the psychological, clinical, and~     physiological effects of the adapted emotional disclosure intervention and the modulating~     role of cognitive-emotional change and individual differences in emotion regulation.~   "
236313|NCT00462332|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. A peripheral stem cell~     transplant using stem cells from the patient or a donor may replace the patient's immune~     cells that were destroyed by chemotherapy.~      PURPOSE: This phase II trial is studying how well giving fludarabine together with~     alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or~     alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic~     leukemia.~   "
236314|NCT00462319|"~     International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for~     patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving~     advices for these 2 points still low. This study evaluates the impact of a standardized~     medical intervention (patient education, weight reduction and physical exercise) in knee~     osteoarthritis patients.~   "
236315|NCT00462306|"~     Obstructive sleep apnea is a condition characterized by obstruction of the upper airways and~     episodes of apnea and hypopnea during sleep. It is associated with significant adverse health~     effects. The incidence of obstructive sleep apnea in the general female population is~     approximately 2% but the incidence of obstructive sleep apnea in pregnancy is unknown. There~     is some evidence that pregnancy precipitates or at least exacerbates this condition and that~     there may be a relationship between intrauterine fetal growth retardation and maternal~     preeclampsia. In addition, there are several anesthetic implications that are concern for the~     patient with obstructive sleep apnea. These include: exquisite sensitivity to all central~     nervous system depressant drugs and the potential for upper airway obstruction or apnea with~     even minimal drug doses; difficult mask ventilation; difficult intubation; arterial~     hypoxemia; arterial hypercarbia; polycythemia; hypertension; pulmonary hypertension and~     cardiac failure. All of these conditions pose significant anesthetic risk for the patient,~     and this risk may be increased further by pregnancy.~   "
236316|NCT00462280|"~     The use of lovastatin may slow disease progression in patients at high risk of melanoma. It~     is not yet known whether lovastatin is more effective than a placebo in treating patients at~     high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or~     placebo works in treating patients at high risk of melanoma.~   "
236317|NCT00462267|"~     This project will examine the effectiveness of a primary care based intervention to help~     overweight teen girls adopt healthy lifestyle practices. Participants will be adolescent~     females from Kaiser Permanente Northwest primary care clinics with a body mass index above~     the 90th percentile. Teens will be randomly assigned to (1) a behavioral weight control~     program (enriched intervention), (2) brief primary care counseling (low intensity~     intervention), or (3) usual-care (control). For both of the project's active intervention~     arms, teens' primary care providers will be given customized plans describing the teen's~     eating and physical activity habits and instructions on how to best work with these teens and~     their families. The behavioral weight control program will be specifically tailored for teen~     girls and will include separate group meetings for teens and parents, follow-up telephone~     contacts with their group leader, and coordinated feedback from the teen's primary care~     provider.~   "
236318|NCT00462254|"~     Patients with Parkinson's disease represent a significant proportion of VA elderly patients.~     Sleep disturbances and caregiver burnout association with this condition represent a~     significant problem. In this study, the investigators propose to perform an evaluation of a~     fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinson's disease.~      The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients~     with Parkinson's disease while indirectly improving the quality of life for the patients and~     caregivers. The investigators further hypothesize that these changes will occur through~     restructuring and normalization of the sleep architecture.~   "
236319|NCT00462241|"~     Acute chest pain is a common cause of hospital admission. Active approaches are directed~     towards diagnosis and treatment of potentially life threatening conditions, especially acute~     coronary syndrome and coronary artery disease. However, a considerable number of patients may~     have chest pain caused by biomechanical dysfunction of muscles and joints of the chest wall~     or the cervical and thoracic spine (20%). The diagnostic approaches and treatment options for~     this group of patients are scarce and there is a lack of formal clinical studies and~     validated outcome measures addressing the effect of manual treatment approaches.~      Objective: This single blind randomized clinical trial investigates whether chiropractic~     treatment can reduce pain and improve function in a population of patients with acute,~     musculoskeletal chest pain when compared to advice directed towards promoting~     self-management.~      Methods: Among patients admitted to a chest pain clinic in a university hospital under~     suspicion of acute coronary syndrome, 120 patients with an episode of acute chest pain of~     musculoskeletal origin are included in the study. All patients have completed the chest pain~     clinic diagnostic procedures, and acute coronary syndrome and other obvious reasons for chest~     pain have been excluded. After completion of the study evaluation program, the patients are~     randomized into one of two groups: A) advice promoting self-management and individual~     instructions focusing on posture and muscle stretch; B) a course of chiropractic therapy of~     up to ten treatment sessions focusing on high velocity, low amplitude manipulation of the~     cervical and thoracic spine together with a choice of mobilisation and soft tissue~     techniques. In order to establish suitable outcome measures, two pilot studies were~     conducted. Outcome measures are pain, function, overall health, and patient-rated treatment~     effect measured at 4, 12, and 52 weeks following treatment.~   "
236320|NCT00462228|"~     The purpose of this study is to determine whether memantine (Namenda) improves memory and~     attention in patients with mild to moderate traumatic brain injury.~   "
236321|NCT00462215|"~     The objectives of this study are to assess the immune response as well as the safety and~     tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the~     study will assess the need for a booster vaccination and whether a 6-month booster or a~     12-month booster is more appropriate. An independent data safety monitoring board will review~     and evaluate the safety data obtained in this study on an ongoing basis.~   "
236322|NCT00462202|"~     The purpose of this study is to assess the tolerability and safety of KRX-101 in treating~     persistent microalbuminuria in type 2 diabetic patients who are also being treated with~     stable, maximum tolerated doses of either ACE inhibitors or A2 receptor blockers.~   "
236323|NCT00462189|"~     RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal~     cells. This may be an effective treatment for hairy cell leukemia(HCL) that has not responded~     to chemotherapy, surgery or radiation therapy.~      PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015~     immunotoxin in treating patients who have hairy cell leukemia (HCL) that has not responded to~     treatment.~   "
236326|NCT00462137|"~     This is a continuation of a study that has already been completed in the division of~     gastroenterology (GI) looking at the effects of sleep medication zolpidem (Ambien) on~     subjects with Gastroesophageal reflux disease (GERD). That study looked at 16 subjects, 8 who~     had been diagnosed with GERD and 8 who did not have GERD (IRB Control #04S.41). All subjects~     previously had a PH probe completed in the division of GI at Thomas Jefferson University. An~     additional 8 subjects with GERD will be recruited to obtain more data to add to the previous~     study results. These subjects will undergo 2 sleep studies, one in which they will be given~     Ambien and one in which they will not.~   "
236327|NCT00462124|"~     Primary Goal The study's primary goal is to assess the safety of the BioProtect biodegradable~     balloon implant and implantation procedure, in prostate cancer subjects undergoing routine~     XRT treatment. Safety of the BioProtect device will be assessed by reporting adverse events.~      Secondary Goal The study's secondary goal is to evaluate the effectiveness of the BioProtect~     biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment.~     Effectiveness will be assessed in terms of increased distance between anterior rectal wall~     and prostate and noticeable reduction of isodose to the rectum.~   "
236328|NCT00462111|"~     The purpose of this study is to determine whether indometacin has an effect on reaction time,~     postural stability, and the avoidance of obstacles.~   "
236329|NCT00462098|"~     Osteonecrosis of the jaw (ONJ) has recently been recognized as associated with bisphosphonate~     therapy, however there is little information on the natural history, treatment or prevention~     strategies for this condition. The purpose of this study is to determine the effectiveness of~     hyperbaric oxygen as a treatment. We will randomize 35 out of 70 ONJ patients to receive HBO~     in addition to their routine oral surgery care and follow both groups over a 2-year period.~   "
236330|NCT00462085|"~     The purpose of this study is to investigate the change in muscle activity during gait with~     the use of ankle foot orthoses in children diagnosed with hemiplegic cerebral palsy.~   "
236331|NCT00462072|"~     Specific Aim 1. To determine the transcriptome of peripheral blood mononuclear cells isolated~     monocytes and target tissues in IMIDs.~      Specific Aim 2. To analyze the change in gene expression profiles in patients with Crohn's~     disease, psoriatic and rheumatoid arthritis before and after infliximab therapy.~   "
236332|NCT00462059|"~     The purpose of this study is to assess and compare the effectiveness of the Kaiser Permanente~     Colorado’s (KPCO) Call Center’s Medication Reconciliation Program and standard care in~     regards to their impacts on emergency department (ED) and urgent care visits, inpatient~     rehospitalizations, and adherence to preferred, formulary medications.~   "
236333|NCT00462046|"~     Berberine has showed effective in lowering blood sugar levels in db/db mice and~     anti-dyslipidemia in human. These findings have not been tested in a clinical trial. This~     randomized, double blind, placebo controlled and multi-center study has demonstrated that~     berberine is effective in lowering plasma glucose concentrations, reducing serum HbA1c and~     anti-dyslipidemia in type 2 diabetic patients with dyslipidemia.~   "
236334|NCT00462020|"~     The objective of this study is to scientifically evaluate two different management strategies~     for perforated appendicitis.~      The hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic~     decrease in medical care expenses for the patient.~      The primary outcome variable between the two strategies is abscess rate.~   "
236335|NCT00462007|"~     An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated~     Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The~     study will consist of 2 consecutive periods: screening period and study treatment period.~     Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will~     be determined by the subject's current, separately administered standard levodopa/DDCI~     treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be~     switched to an equivalent dose of Stalevo® without changing the number of doses per day. The~     levodopa daily dose during Stalevo® treatment may be adjusted according to the study~     subject's clinical response.~   "
236336|NCT00461994|"~     A 3-arms randomized prospective intervention study to determine the roles of exercise and/or~     diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with~     BMI> 95th percentile for age and gender. Children were randomly allocated into three groups.~     The first group underwent an exercise program, the second one underwent both an exercise~     program and a diet program and the third underwent a diet program alone.~      The total duration of the intervention is 12 weeks followed by a period of 9 months of~     follow-up. The effects of the different intervention on weight loss and weight~     maintenance,body composition, on hormonal components that regulate the caloric balance, on~     metabolic profile and cardiovascular risk factors and on psychological parameters were also~     determined.~   "
236337|NCT00461981|"~     The primary objective of this study is to describe the level of serum antibody and cellular~     immune responses conferred by FluMist and TIV against influenza virus strains.~   "
236338|NCT00461968|"~     The purpose of this study is to compare the percent change in LDL cholesterol induced by~     ezetimibe or simvastatin monotherapy and by co-administration of both agents in Black, White~     and Hispanic men. Ezetimibe is a drug that blocks sterol absorption and simvastatin blocks~     hepatic cholesterol biosynthesis. The hypothesis to be tested is that Blacks are likely to be~     more responsive to LDL lowering by ezetimibe than statins because Blacks have a low~     production of cholesterol.~   "
236339|NCT00461955|"~     Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after~     injection of ex vivo amplified graft and by a platelets number > 20000/mm3, at day 15 after~     the injection of ex vivo amplified graft, without transfusion.~   "
236340|NCT00461942|"~     The purpose of this study is to determine whether Green Tea Polyphenol, an extraction from~     Green Tea is effective and safe in the treatment of De Novo Parkinson's disease Patients~     without taking any antiparkinsonism drug~   "
236341|NCT00461929|"~     In order to distinguish between clonal instability driven by imatinib in CML and actual~     changes with secondary clones induced by imatinib we would like to investigate the karyotype~     of non-CML patients treated with imatinib such as GIST patients.~   "
236342|NCT00461916|"~     The purpose of this study is to determine whether half-dose depot triptorelin are as~     effective as reduced-dose daily buserelin in the controlled ovarian stimulation for~     intracytoplasmic sperm injection and embryo transfer~   "
236344|NCT00461890|"~     The goal of the proposed project is to improve the primary care treatment of veterans with~     alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans~     treated in VA primary care clinics. However, assessment and treatment of alcohol dependence~     in primary care remains problematic. Assessment of veterans with positive alcohol use screens~     may not always be completed and referrals to specialty care may not always be made. Moreover,~     the use of medications for alcohol dependence among veterans is rare, despite VA treatment~     guidelines that recommend such use. Finally, when medications are prescribed, patients may~     have difficulties with adherence.~      The primary aim of this study is to assess the feasibility of long-acting injectable~     naltrexone provided through primary care (LAN/PC) versus long-acting injectable naltrexone in~     the specialized chemical dependence clinic (LAN/CDC). The secondary aim is to obtain~     preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in~     primary care versus in the chemical dependence clinic.~   "
236345|NCT00461877|"~     The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year~     old women who report having used internet dating websites in the past year.~   "
236346|NCT00461864|"~     occult hip fractures present to the emergency room with a history of trauma,a painful hip and~     normal X-ray. these patients usually undergo other imaging modalities such as CT scans, MRI,~     or bone scans.~      In this study we check the sensitivity and specificity of a directed ultrasound examination~     of the hip joint in diagnosing or excluding a hip fracture. We also compare the results of~     ultrasound examination by the orthopedic surgeon in the emergency room versus the consultant~     radiologist.~      The patients undergo bone scans or CT to make the diagnosis.~   "
236347|NCT00461851|"~     This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression~     and response proportion of patients with advanced or metastatic transitional cell carcinoma~     of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance~     sorafenib.~   "
236348|NCT00461838|"~     Improved pain, sexuality and quality of life, high fertility and low complication and~     recurrence rates after multidisciplinary CO2 laser laparoscopic excision of deep infiltrating~     colorectal endometriosis.~   "
236349|NCT00461825|"~     We have previously defined factors that predict the long term success of maintenance CsA~     monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine~     level at the initiation of CsAm £ 125 µmol/L, no rejection episode before CsAm initiation. We~     have also shown that the 8-year graft survival in 329 selected patients enrolled in~     maintenance CsA-m was 84 % (Hurault de Ligny et al, Transplantation, 2000 ; 69 : 1327-1332).~     These results were obtained with an old formulation of cyclosporin, azathioprine, steroid~     withdrawal over the first year and induction antibody. This prospective randomized~     multicentre study was designed to clarify whether maintenance Neoral + MMF or Neoral + AZA is~     better than a CsAm and wether Neoral + MMF is better than Neoral + AZA in low immunological~     risk cadaveric kidney transplant recipients.~   "
236350|NCT00461812|"~     The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate~     comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in~     control of mild persistent asthma?~      The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy~     with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50,~     when measured by this standard methodology (methacholine bronchoprovocation) in subjects with~     mild persistent asthma.~   "
236351|NCT00461799|"~     The purpose of this study was to determine whether orlistat is effective in decreasing plasma~     unconjugated bilirubin levels in patients with Crigler-Najjar disease.~   "
236352|NCT00461786|"~     The primary purpose of this trial is to estimate the drug effect on tumors in patients with~     ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until~     disease progression or unacceptable toxicity. This medication will be given over 10 minutes~     and may be administered intravenously (IV), through a vein in your arm. Vitamin~     supplementation is a required part of this study.~   "
236353|NCT00461773|"~     The purpose of this study is to evaluate the objective response rate of a combination of~     letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients~     with hormone sensitive breast cancer.~   "
236354|NCT00461760|"~     This is a randomised controlled trial of HPV testing with cytology triage for HPV positive~     women compared to liquid-based cervical cytology (LBC). Although LBC is not widely used for~     cervical cancer screening in Canada at present, the Pan-Canadian Cervical Cancer Forum has~     recommended its use and as it is likely to be the standard of care by the time these data are~     published, the trial has been designed to account for this. Further, LBC will improve the~     cost-effectiveness of HPV testing because the LBC medium is suitable for both HPV testing as~     well as cytology and thereby allows the triage testing to be undertaken from the same sample~     without having to recall the women.~   "
236355|NCT00461747|"~     The primary objective is to compare safety and efficacy of three induction treatments:~     VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide /~     Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the~     treatments in order to do an autologous transplant. Otherwise this study wants to compare the~     safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus~     Thalidomide/Velcade.~   "
236356|NCT00461734|"~     This study will be done in patients who require the implantation of a cardiac pacemaker (an~     electronic device that controls the heartbeat) for complete heart block (a heart rhythm~     abnormality resulting in a slow heart beat). Pacemakers regulate the heart beat by delivering~     pulses of electricity through special wires (pacing leads) which are placed inside the heart.~      This study will compare two groups of pacemaker patients. Each group will have their pacing~     leads placed in a particular location in the heart. The purpose of the study is to show~     whether the position used in one group is better for maintaining effective heart function~     compared to the position used in the other group.~      The leads in one group will be placed in a position called the Right Ventricular Apex. This~     is the traditional and most frequently used position for pacemaker leads.~      The leads in the other group will be placed in a position called the Right Ventricular High~     Septum. This is a less commonly used position, but may result in health benefits for the~     patients compared with the Right Ventricular Apex.~   "
236357|NCT00461721|"~     To find a test to elaborate a parameter for specific immunotherapy in allergic patients~   "
236359|NCT00461695|"~     Recent studies indicate that persistent viral infections particularly with Cytomegalovirus~     (CMV) might have a negative impact on immune senescence (i.e. immunocompetence of elderly~     individuals). We will test this hypothesis by performing a vaccination trial in healthy~     elderly individuals subdivided in two groups of CMV-seropositive and CMV-seronegative~     individuals. All individuals will be vaccinated with the currently licensed vaccine for the~     prevention of TBE (FSME Immun CC) which is recommended for the general population in our~     area. Vaccination efficacy will be monitored longitudinally concerning the TBEV-specific~     antibody (TBEV-neutralization, TBEV-specific ELISA) and T cell response (ELISpot, cytokine~     production).~      Vaccination efficacy will be compared between CMV+ and CMV- individuals and correlated with~     the CMV-specific immune response in CMV+ individuals.~   "
236360|NCT00461682|"~     SB-705498 has demonstrated efficacy in several preclinical and human experimental pain~     models. This study will investigate the efficacy of SB-705498 in patients with rectal pain.~     This will be a double-blind, placebo-controlled, two-way crossover study. 21 patients with~     faecal urgency (Group 1), and 21 patients with IBS (Group 2) will complete this study.~   "
236361|NCT00461669|"~     Hip fractures are usually classified according to their X-ray as subcapital, pertrochanteric.~     We examine hip fractures with ultrasound in order to characterize the fractures with several~     parameters.~   "
236362|NCT00461656|"~     The purpose of this study is to compare the efficacy of 5 % vs. 1.25 % povidone-iodine (PI)~     as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of~     endophthalmitis. Given the low rate of endophthalmitis the conjunctival bacterial flora rate~     is used as surrogate marker to determine the effectiveness of topical PI in reducing or~     eliminating bacteria from the ocular surface at the time of the surgery. Secondary objective~     is a reduction of the incidence of postoperative endophthalmitis after strabismus surgery in~     young children.~   "
236363|NCT00461643|"~     Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if~     several first-step treatments have been proposed for anovulatory infertile PCOS patients,~     very few data are available in literature regarding the best integrated strategy. In fact, a~     single compound could be effective as first-step approach but not or less useful when~     integrated in a more complex strategy.~      The goal of the current protocol will be to compare three different strategies for treating~     anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy~     rate.~   "
236364|NCT00461630|"~     The primary aim is to assess the effects of raising HDL cholesterol (the good type) with~     extended release niacin/laropiprant 2g (previously known as MK−0524A) versus matching placebo~     on the risk of heart attack or coronary death, stroke, or the need for arterial bypass~     procedures (revascularisation) in people with a history of circulatory problems. The~     secondary aim is to assess the effects of extended release niacin/laropiprant 2g daily on~     heart attack, coronary death, stroke, and revascularisation separately and to assess the~     effects on mortality both overall and in various categories of causes of death, and of the~     effects on major cardiovascular events in people with a history of different diseases at the~     beginning of the study.~   "
236365|NCT00461617|"~     The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to~     Nateglinide for the treatment of type 2 diabetes.~   "
236366|NCT00461604|"~     It has been reported that Baclofen is an appropriate tool in the therapeutic management of~     Gastroesophageal Reflux Disease. To objectify gastroesophageal reflux combined~     pH-metry/impedance monitoring was applied to patients with persistent reflux-associated~     symptoms despite PPI-therapy (40mg esomeprazole for 2 weeks). After provement of pathological~     findings in the test PPI-dosage was escalated to double standard-dosage for another for~     weeks. In case of persistent symptoms another ph-metry/impedance monitoring was performed. In~     case of pathological findings additional baclofen was administered to the therapeutic regime.~     After 3 months another ph-metry/impedance monitoring was performed. At the time point of the~     tests a questionnaire was completed.~      Aim of the study was to evaluate the influence of high dosage PPI-therapy and additional~     baclofen in patients with persistent symptoms and objectified gastroesophageal reflux.~   "
236367|NCT00461591|"~     The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in~     randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of~     Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.~   "
236368|NCT00461578|"~     In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of~     the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with~     uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up~     until day 28 after treatment. Adverse events, clinical and parasitological outcomes were~     recorded.~   "
236369|NCT00461565|"~     Vardenafil (Levitra) and Sildenafil (Viagra) are drugs that are marketed for use in patients~     with erectile dysfunction. The purpose of this study is to find out if there are any changes~     in the eye after taking at least 15 doses of Vardenafil and after two doses of Sildenafil.~     This is a double-blind study, which means that neither you nor the study doctor will know~     which treatment you are receiving. If you qualify for the study, you will receive:-~     Vardenafil 20 mg twice per week (Monday and Thursday) for a maximum of 8 weeks. There will be~     two times when this occurs during the study.- Sildenafil 200 mg/day for two days. There will~     be two times when this occurs during the study. - Placebo (a pill that looks like vardenafil~     or sildenafil but has no active ingredient).~   "
236370|NCT00461552|"~     To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced~     lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a~     high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary~     advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These~     interventions are aimed at improving the metabolic complications of HAART therapy such as~     elevated lipids, and insulin resistance or diabetes.~   "
236371|NCT00461539|"~     This study will determine the effectiveness of a health education intervention in reducing~     health risk behavior and improving health in adolescents with depression.~   "
236422|NCT00460863|"~     The purpose of this study is to test a novel application of an existing treatment - using col~     dialysate (often used to treat hypotension) as opposed to warm dialysate (standard treatment)~     during hemodialysis for its ability to stabilize the sleep/wake cycle of patients receiving~     this chronic treatment~   "
236372|NCT00461526|"~     Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS)~      The purpose of this study is to investigate the safety and effectiveness of a new~     investigational drug in women for the treatment of diarrhea-predominant irritable bowel~     syndrome. The investigational drug is a natural product taken from a plant that grows in~     South America. The study medication will be administered orally twice a day. Subjects will be~     not able to remain on certain standard IBS medications (anti-diarrheals) while participating~     in the study. The total duration of the study is 18 weeks.~      The study requires five study visits that include physical exams, ECG, blood draws,~     laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy if~     an appropriate procedure has not been performed in the last 5 years.) Participants will be~     asked to make entries into a touch-tone telephone diary on a daily basis.~      Participants must meet all of the following criteria:~        -  Females at least 18 years of age~        -  Diagnosis of diarrhea predominant Irritable Bowel Syndrome~        -  Willingness to make daily calls on a touch-tone telephone~        -  Willingness to have an endoscopic and/or radiologic bowel evaluation, if you have not~          received one in the past 5 years.~        -  Willingness to take an approved method of birth control (if required)~      Participants CANNOT meet any of the following criteria:~        -  Serious medical or surgical conditions~        -  Colon Cancer, Crohns Disease or Ulcerative Colitis~        -  Pregnant or breast feeding~   "
236373|NCT00461513|"~     The purpose of this study is to evaluate a patient-centered disease management intervention~     for VA patients with heart failure.~   "
236374|NCT00461500|"~     This study will compare during 12 weeks, two treatment strategies for Initial Maintenance~     Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination~     in adults with moderate persistent asthma~   "
236375|NCT00461487|"~     This study will evaluate the effectiveness of a parent-based intervention in reducing sexual~     risk behavior in high-risk Latino and African-American adolescents.~   "
236376|NCT00461474|"~     The purpose of this study is to conduct research to see if we can help people who have a~     spinal cord injury and shoulder pain to decrease the pain in the shoulders. We are~     investigating the effectiveness of a home exercise program for the shoulders and changes in~     how tasks are performed compared to an educational program on shoulder pain. There are no new~     experimental procedures included in this study; instead it is a comparison of two types of~     treatment that have been provided for this problem before. The new part of this study is the~     collecting of information before and after treatment. We hypothesize that those who~     participate in this home exercise program will have decrease shoulder pain and increase~     activity.~   "
236377|NCT00461461|"~     Medical errors that affect patient safety have generated huge concern since the publication~     of To Err Is Human 6 years ago [1]. Given the complexity of management in the intensive~     care unit (ICU) and the nature of human activities, critically ill patients are exposed to~     adverse events (AEs) induced by medical errors. A large number of studies have focused on AEs~     and medical errors in ICUs [2-6], one of their main goals being to identify strategies for~     preventing AEs and thereby improving patient outcomes. Choosing the best AE to serve as an~     indicator for the risk of medical error is challenging. In 2005, our group conducted a~     systematic literature review and presented the results to 30 national experts with clinical~     backgrounds in internal, emergency, and intensive care medicine. Using the Delphi technique,~     these experts selected 14 AEs that had the following characteristics: high frequency, easy~     and reproducible definition, association with morbidity and mortality, and ease of reporting~     without fear of punishment (Iatroref I study) (ref abstract). These AEs were used in a French~     multicenter study (75 ICUs) for a weeklong incidence evaluation (Iatroref II study) (ref~     abstract). Preliminary evaluation of the results allowed us to choose the following AEs for~     the current Iatroref III study: error in insulin administration, error in anticoagulant~     administration, error in anticoagulant prescription, unplanned extubation, and unplanned~     removal of central venous catheter. Evidence suggests that guidelines alone without~     reinforcing strategies may be insufficient to change provider behavior and that the most~     effective interventions may be multifaceted rather than single-component strategies ([7]).~     This study will test a composite intervention program. The objectives of the study are to~     determine whether the introduction of a composite intervention program decreases the~     predefined AEs.~      Study hypothesis: The intervention program will decrease the incidence of the predefined AEs.~   "
236378|NCT00461448|"~     Rheumatoid arthritis is the paradigmatic immune-mediated inflammatory arthropathy. With~     respect to rheumatoid arthritis (RA), patients have been described as having inappropriately~     low spontaneous and stimulated cortisol secretion levels. Serum cortisol levels are decreased~     in RA patients who are taking prednisolone. Also, in patients RA, of longer duration,~     glucocorticoid receptor (GR) down-regulation has been reported without any change in cortisol~     levels. There is a reduced capacity for local reactivation of cortisone to cortisol in RA~     synovial cells. It is noteworthy that since synthetic glucocorticoids also use same~     reactivation shuttle (the cortisol-cortisone shuttle), the results also apply to therapeutic~     glucocorticoids.~      Glucocorticoids are widely used to treat chronic inflammatory conditions including rheumatoid~     arthritis. Prednisolone has a greater effect than non-steroidal, anti-inflammatory drugs on~     joint tenderness and pain, whereas the difference in grip strength was not significant. There~     are no qualitative differences between the effects of endogenous cortisol and exogenously~     applied synthetic glucocorticoids, since all effects are transmitted via the same receptor.~     Cortisol, on the other hand, plays a major role in normal potassium homeostasis.~      Recent studies have highlighted a role for diet, with suggestions that diets high in~     caffeine, low in antioxidants and high in red meat may contribute to an increased risk for~     the development of rheumatoid arthritis. Higher intakes of complex carbohydrates, dietary~     fiber, magnesium, folic acid, vitamin C and E, carotenoids and other phytochemicals have been~     shown to offer distinct advantages compared to diets containing meat and other foods of~     animal origin. The relation of a potassium deficiency to RA is much less well documented. The~     first person to definitively link potassium with arthritis was DeCoti Marsh. LaCelle, Morgan~     & Atwater found that the cells of 50 arthritic patients were 30 to 50% lower than healthy~     people.~      Our current clinical trial (clinical trial no NCT00399282) shows that most of patients with~     RA do not have enough potassium intake. This condition may contribute to a subclinical lower~     serum cortisol, although there is possibility that cortisol serum levels might be unchanged~     due to a sufficient cortisol homeostasis and potassium homeostasis.~   "
236379|NCT00461435|"~     Our aim was to assess the role and usefulness of Hyperbaric oxygen therapy in a long lasting~     period, assessing its efficacy on rescuing retinal photoreceptors and preserving visual~     function in retinitis pigmentosa.~   "
236380|NCT00461422|"~     Our goal was to investigate whether early follicular supplementation of the GnRH antagonist~     to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results~   "
236381|NCT00461409|"~     The purpose of this study is to determine the correct dosing for intravenous levetiracetam in~     term new born babies with seizures. In addition information on safety and efficacy will be~     collected. This new anticonvulsant drug is a promising treatment for seizures in newborns.~   "
236423|NCT00460850|"~     This single arm study will evaluate the efficacy and safety of PEGASYS in patients with~     lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180~     micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of~     treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the~     target sample size is <100 individuals.~   "
236382|NCT00461396|"~     -  The primary aim of this study is to evaluate the impact of titration, analgesics, and 12~          month telephone follow-up period from the B.E.T.A nurse program upon adherence to~          treatment with Betaseron in patients with a first clinical demyelinating event~          suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS within the past 12~          months~        -  Secondary outcomes include analysis of the following parameters: progression of clinical~          severity by the expanded disability status scale (EDSS score), health related quality of~          life (HrQoL), and safety.~        -  Exploratory outcomes include changes over time in cytokine and neurotrophic factor~          production by immune cells and visual function as assessed by visual examination, OCT~          measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire~          (NEI-VFQ-25) with 10-item supplement.~   "
236383|NCT00461370|"~     The purpose of this study is to determine the safety of SRX251 when given orally. The amount~     of SRX251 in the blood will also be measured. Healthy women, ages 18-50 years who have been~     surgically sterilized by tubal ligation, will be enrolled in this study.~   "
236384|NCT00461357|"~     The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from~     deceased donors elder than 65 years to recipients elder than 65 years. The requirements for~     immunosuppression in this group of patients are high due to the large amount of~     comorbidities.~      This prospective randomized trial compared the standard immunosuppressive protocol based on~     cyclosporine A (CyA) used at our center within the ESP, to a calcineurin inhibitor-free~     protocol based on sirolimus (SRL).~      The aim of this study is to investigate the effect of a CNI-free therapy on the function of~     elderly kidneys 6 months post transplantation, measured by GFR.~   "
236385|NCT00461344|"~     Primary: To determine the pathological remission following the chemotherapy combination~     docetaxel and doxorubicin in large breast cancer~      Secondary:~        -  Clinical response rate~        -  To investigate the safety of docetaxel doxorubicin combination in the treatment for~          neoadjuvant chemotherapy of breast cancer~        -  Type of surgery (radical/conservative)~   "
236386|NCT00461331|"~     The purpose of the study is to compare the glycemic control between insulins aspart and~     lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes~     using an insulin pump.~   "
236387|NCT00461318|"~     The primary aim of the study was to determine the effectiveness of a form of supported~     employment, Individual Placement and Support (IPS) compared to existing good quality~     rehabilitation and vocational services for people with psychotic illnesses in terms of ‘open’~     employment outcomes (in the competitive labour market), and to examine its relative~     effectiveness in the context of different European welfare systems and labour markets. The~     primary hypothesis was that IPS patients would be more likely to obtain open employment than~     control service patients. Secondary hypotheses were that they would be in open employment for~     longer than the control patients, and that they would not spend more time in hospital.~   "
236388|NCT00461305|"~     The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic~     bleeding profile in patients with dysmenorrhea and to investigate the long term safety~   "
236389|NCT00461292|"~     The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A~     in treating overactive bladder in spinal cord injury or multiple sclerosis patients~   "
236390|NCT00461279|"~     In this study, the focus is on an individual's attachment security and its relation to~     treatment outcome in Major Depression.Adult attachment reflects how one seeks psychological~     and physical proximity to others for security and protection in times of stress. Researchers~     typically define four types of attachment security: one secure and three insecure~     (preoccupied, dismissing, and fearful). Adults with Major Depressive Disorder (MDD) will be~     randomly assigned to either Interpersonal Psychotherapy (IPT) or to Cognitive Behavior~     Therapy (CBT). The expectation is that adults with avoidant attachment styles will respond~     better to CBT, and adults with preoccupied attachment styles will respond better to IPT.~     Also, in comparison to CBT, outcome in IPT is hypothesized to be more closely related to~     change in attachment.~   "
236391|NCT00461266|"~     This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral~     regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an~     HIV RNA viral load <400 copies/mL. Eligible patients will be randomized to receive Fuzeon~     90mg bid sc in addition to their current antiretroviral therapy, or to continue their current~     antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the~     target sample size is <100 individuals.~   "
236392|NCT00461253|"~     The objective of this study is to determine the breast cancer risk of Mirena® users compared~     to copper intrauterine device (IUD) users in a community-based case-control study.~   "
236393|NCT00461240|"~     Growth hormone (GH) is important for growth in childhood, but also has important effects on a~     number of tissues throughout life. GH deficiency and GH excess (acromegaly, caused by a~     pituitary tumour) are both cause serious abnormalities of metabolism and long−standing~     abnormal GH status causes abnormal heart function. In both cases cardiovascular disease is a~     leading cause of early (premature) death. In the current study we wish to investigate the~     energy status of the heart in patients with GH excess and deficiency and compare that with~     age−matched controls. We will perform a blood test to study metabolic parameters. We will~     perform measurements before treatment, after normalisation of improvement of GH levels and 2~     years after start of treatment.~      Objectives~        1. Determine cardiac and skeletal muscle energy metabolism in patients with GH excess~          (=acromegaly) or GH deficiency and detect changes after normalisation of GH and IGF−1~          levels. (IGF−I is a hormone directly influenced by GH)~        2. To correlate muscle energy metabolism parameters to GH and IGF−1 status in the control~          subjects and in both patient groups~        3. Determine the prevalence of coronary artery calcifications in patients with GH excess~          and GH deficiency and correlate this with their metabolic status~        4. To correlate coronary artery calcifications to abdominal obesity. Patients will be~          identified by Endocrinology physicians involved in the study in outpatients clinics or~          Endocrine wards and they will receive standard care for their disease. Tests related to~          endocrine hormone abnormalities will be performed as usual clinical practice. The study~          will involve three 3−hour visits to the Oxford Research Centre and two 1−hour visits to~          London Scanning Centre.~      The visits at the Oxford research centre will include Cardiac and skeletal investigations~        -  Standard cardiac MRI will be used to measure right and left ventricular morphology and~          global function.~        -  31P Magnetic Resonance Spectroscopy (MRS) to monitor heart muscle energy levels (by~          measuring intracellular PCr and ATP in heart muscle).~        -  Heart failure severity (so called 'NYHA status') will be determined from the 6 min walk~          test.~        -  Peak oxygen uptake will be estimated from a metabolic gas exchange analysis performed~          during maximal treadmill exercise testing.~        -  Skeletal muscle MR imaging and spectroscopy will be performed at rest and during~          exercise.~        -  Fasting blood test will be performed, see details in protocol.~        -  Electrocardiogram (ECG)~        -  Epworth Sleepiness Scale questionnaire and 5 point test for sleep apnoea The visits at~          the London Scanning Centre will include~        -  Electron beam coronary CT (EBCT) to assess coronary disease. The number of coronary~          disease lesions will be measured in several coronary arteries and values will add up to~          an overall score. In addition a single picture will be taken at the level of the~          umbilicus (belly button) to measure fat tissue within the abdomen. Patient selection:~          Patients will be recruited at St. Bartholomew's Hospital (Dr P. Jenkins and Prof. A.~          Grossman), King's Hospital (Dr S. Aylwin) and St Thomas's Hospital (Dr P. Carroll) in~          London, Royal Free Hospital (Prof P. Boloux), the John Radcliffe Hospital Oxford (Prof~          J. Wass), Addenbrooks Hospital Cambridge (Dr H. Simpson), Sheffield (Dr J.~          Newell−Price), and Stroke−on−Trent (Prof R. Clayton) from the Endocrine Wards and~          outpatient clinics. This constitutes a large recruitment base. We estimate that 45 new~          acromegaly patients and 60−80 new GHD patients per year will be screened. Patients will~          be selected on the basis of clinical diagnosis of acromegaly or GH deficiency (see~          details of these in the formal protocol).~      Patients will be managed according to the clinical protocols of the referring centre.~      The patients will have a report of their investigation results with their treating~     physicians.~      Control subjects will be selected from the general population via advertisements. They will~     undergo all tests in the Oxford centre once.~      Expected value of results:~      These studies will increase our knowledge of the metabolic changes associated with GH excess~     and GH deficiency, which can lead to increased cardiac morbidity and mortality in both cases.~     Our studies will help to clarify the mechanism of abnormal cardiac function. The study has~     been powered to have appropriate number of subjects within a two year period, therefore we~     anticipate that it will last from start to finish 4 years.~   "
236394|NCT00461227|"~     Asthma is a major public health problem among Puerto Ricans. Little is known, however, about~     the effect of heredity and environment on the development and severity of asthma in this~     population. This study will examine the relationship between asthma and certain genetic and~     environmental factors in Puerto Rican children.~   "
236395|NCT00461214|"~     The purpose of the General Surgery Training Outcomes Project: Evaluating the Impact of the~     Curriculum on General Surgery Resident Training and Evaluation is to analyze data collected~     as a normal course of the general surgery curriculum. The information collected is data~     readily available and routinely collected on all participants in the general surgery~     curriculum at NewYork Presbyterian Hospital/Columbia Campus. This information may lead to~     improvement in the general surgery curriculum.~   "
236396|NCT00461201|"~     The purpose of this study is to compare the effectiveness of nursing care in relation to~     usual medical care in adult patients who demand to be visited the same day in Primary Care~     Teams in Catalonia, as it is suggested in other countries.~   "
236397|NCT00461188|"~     The research is aimed at identifying new predisposition genes for endocrine tumours. Our~     focus initially is on pituitary adenomas including growth hormone-secreting tumors~     (somatotrophinomas) and prolactin secreting tumours (prolactinomas), but we wish to extend~     work to other pituitary tumour cases/families.~      The recruitment process will be as follows.~        1. We will recruit patients from our own Endocrine outpatient clinics and inpatient wards.~          In addition we will ask colleagues in other Endocrinology Departments (or other~          specialties such as Clinical Genetics,Pathology, General Medicine ) to identify~          potentially suitable patients with endocrine & pituitary tumours from their records. We~          shall focus on patients with good evidence of inheritance of their condition: relatively~          early onset; or multiple lesions; or other affected family members. Conditions where the~          predisposing genes have been identified (principally MEN) will be excluded from study.~          Patients directly contacting us can also enter the study.~        2. The Consultant looking after the patient will contact the patient to initially inform~          him/her of the study.~        3. We will then contact the patient (generally by telephone) to discuss the study and what~          it would entail in terms of information and samples.~        4. Subject to agreement in (3), patient will receive 'Information Sheet for patients with~          pituitary tumour' and 'Consent Form' and will have blood sampling in Consultant's~          clinic.~        5. We will contact additional family members (if appropriate) after an initial approach by~          the family member already recruited to the study. The additional family members may have~          developed tumours similar to those of the proband, or may be unaffected individuals who~          provide useful information for gene identification purposes (for example, spouses may~          greatly aid the power of gene mapping by linkage. They will receive the Information~          Sheet for family members. analysis).~      8. Archival tissue will be obtained from HTA licensed tissue banks. This is an established~     bank whose licence is primarily for diagnosis but can be used for research. 9. We will~     undertake laboratory work, such as genetic linkage analysis, candidate gene mutation~     screening and studies of loss of heterozygosity in tumours, to identify the genes~     predisposing to the condition, such as the AIP gene. In addition we would like to screen~     other genes related to the chaperon AIP molecule, such as AhR, and other genes currently~     identified (PDE4A5, survivin and Tom20 protein) or may not been identified.~      Blood samples for DNA and RNA will coded with unique ID numbers. Pituitary and other~     endocrine tumour samples will be collected at surgery and kept in liquid nitrogen or −80 C.~     They will be coded with unique ID numbers. Candidate gene sequencing will be performed in the~     Barts and the London Medical School Genome Centre.~      RNA expression studies from blood or adenoma tissue samples will be performed by RT−PCR.~     Protein expression studies will be performed by Western blotting or immunohistochemistry. The~     first gene we wish to study causes familial acromegaly, a disease resulting from a pituitary~     adenoma secreting growth hormone.~      To establish if the candidate gene is also causing possibly sporadic (not familial) cases of~     the disease, samples (blood and tissue) will be collected from patients with sporadic disease~     and will be analysed as above.~   "
236398|NCT00461175|"~     The primary objective of the study is to assess the risks of intrauterine device (IUD) use in~     a study population that is representative for the actual users of the individual IUDs. The~     primary clinical outcome of interest is the uterine perforation rate.~   "
236424|NCT00460837|"~     The study will compare patient's experience between those taking a standard bowel cleansing~     regimen with minimal laxative tagging regimen of senna and gastrofin. Additionally comparing~     any possible reduction in diagnostic accuracy that may ensue from an increased quantity of~     retained faecal residue.~   "
236399|NCT00461162|"~     Chronic obstructive pulmonary disease, including emphysema and chronic bronchitis, is the~     fourth most common cause of death and the second leading cause of disability in the United~     States. COPD is estimated to be responsible for more than 13.4 million physician visits and~     13% of hospitalizations nationally. These hospitalizations are usually caused by acute~     exacerbations characterized by an increase in symptoms including dyspnea or shortness of~     breath (SOB), cough, wheezing, and sputum production. The significant disability for people~     with COPD is primarily due to the symptom of dyspnea (shortness of breath) that affects an~     individual's quality of life more than does the physiological impairment. Despite optimal~     medical and pharmacological therapy, most people with COPD continue to suffer from chronic~     and progressive dyspnea and other symptoms of cough and fatigue.~      We have previously shown that an individualized face-to-face dyspnea self-management program~     was effective in improving dyspnea with activities of daily living (ADL), physical~     functioning, and self-efficacy for managing dyspnea. Using an experimental longitudinal~     design, the i-DSMP will be compared to the Face-to-Face Dyspnea Self-Management Program~     (f-DSMP) and to an Attention Control (AC) intervention~   "
236400|NCT00461149|"~     Epidemiological data indicate that patients with active acromegaly have reduced life~     expectancy because of cardiovascular (60%) and respiratory diseases (25%) mainly (1-10). A~     post-treatment GH value <5 mU/liter (equal to <2.5 μg/liter) and IGF-I in the normal range~     for age are recognized as the most predictive survival indices.~      Since their introduction into clinical use approximately two decades ago, somatostatin~     analogs have been considered a cornerstone of medical therapy for acromegaly. After 12 months~     of treatment with octreotide-LAR, control of GH and IGF-I excess, is achieved in 54% and 63%~     of unselected patients (11). The proportion of subjects achieving IGF-I normalization~     increases significantly with time (12). Significant tumor shrinkage has also been reported in~     a number of studies (13,14): an average 50% tumor decrease is achieved when the drug is used~     exclusively, or before surgery or radiotherapy (14). In 99 unselected newly diagnosed~     patients after 12 months of treatment with somatostatin analogues we reported control of GH~     levels in 57.6% and IGF-I levels in 45.5% and a greater than 50% tumor shrinkage in 44.4%~     (15).~      The dose of LAR in different studies ranged from 10-40 mg every 28 days (q28d): high doses~     are generally administered in patients who do not control GH and IGF-I excess with lower~     doses. As reported in the meta-analysis (11) the rate of IGF-I normalization tended to be~     lower as octreotide-LAR dose was raised: 90% in patients treated with 10 mg, 61% with 20 mg~     and 53% with 30 mg. However, some further benefit by increasing the dose of octreotide-LAR~     was reported in some studies (16-18).~      Data on dose escalation of octreotide-LAR given as first-line therapy in newly diagnosed~     patients with acromegaly are lacking.~   "
236401|NCT00461136|"~     This study will evaluate the time-course of the antiproteinuric effect of renin inhibition~     with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established~     nephropathy.~   "
236402|NCT00461123|"~     The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin.~     In the presence of hemoglobin, its application causes vaporization of the tissue and this~     effect depends on the concentration of hemoglobin in the respective tissue. Therefore,~     increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of~     the laser application and consequently shortening of the required duration of laser~     application.~   "
236403|NCT00461110|"~     The purpose of this study is to determine the maximum tolerated dose and assess the safety~     and tolerability of escalating doses of BMS-663513 when given in combination with either~     radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.~   "
236404|NCT00461097|"~     The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a~     child with an allergy to egg and eventually lead to the development of tolerance to egg.~   "
236405|NCT00461084|"~     The purpose of this study is to see if a treatment with Biaxin (clarithromycin) which is an~     antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the~     lymphoma. We would also like to see how Biaxin (clarithromycin) works on lymphoma and blood~     cells.There is some evidence that this medication may change the behavior of lymphocytes, in~     addition to its known anti-infection activity.~   "
236406|NCT00461071|"~     The purpose of this study is to evaluate the effectivity of guided self-help via Internet and~     bibliotherapy in the treatment of bulimia nervosa (BN) in young women.~   "
236407|NCT00461058|"~     This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos~     in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible~     patients will be randomized to receive either aleglitazar, titrated to an individual maximum~     tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated~     dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
236408|NCT00461045|"~     This is a Phase 2, open-label, multicenter study examining the safety, pharmacokinetics and~     pharmacodynamics, and best overall response to escalating doses of the proteasome inhibitor~     NPI-0052 (also known as marizomib) in patients with relapsed or relapsed/refractory multiple~     myeloma. NPI-0052 is a novel, second generation proteasome inhibitor that prevents the~     breakdown of proteins involved in signal transduction which blocks growth and survival in~     cancer cells. The study is a Phase 2 study and is a 2-stage efficacy design in a selected~     subgroup of patients (Arm C) treated with the recommended phase 2 dose of NPI-0052, as~     determined in a previously completed Phase 1 study. The study is to evaluate the safety and~     any preliminary evidence of efficacy of NPI-0052 in multiple myeloma patients who have~     previously received carfilzomib (PR-171, Kyprolis™) and subsequently had disease progression.~   "
236409|NCT00461032|"~     This study, in children with chronic asthma, evaluates the number of days of worsening asthma~     during 8 weeks of treatment with montelukast after treatment is started for the first day of~     school.~   "
236464|NCT00460304|"~     The primary objective is to establish the mean percentage of change in the~     insulin-to-carbohydrate ratio due to pramlintide treatment once a maximum tolerated dose or 6~     mcg before each meal is reached. The secondary objective is to establish which insulin bolus~     wave form is associated with the lowest post-bolus without hypoglycemia in subjects treated~     with maximum pramlintide dosage.~   "
236410|NCT00461019|"~     Congestive Heart Failure is the result of a number of diseases affecting the heart, causing~     the heart's failure to properly meet the body demands for blood circulation. In spite of~     advances in drug therapy, it remains a significant public health problem.~      Pharmacologic antagonism of the beta-adrenergic receptors shifting the autonomic balance in~     the direction of greater vagal influence is a well-proven treatment for heart failure~     patients, although there are patients who cannot tolerate, or only partially benefit from~     such a treatment.~      It has been proven in the past and well established that parasympathetic nerve stimulation~     can slow the rate of the heart and reduce the workload of the heart. Therefore, the potential~     benefit of vagus nerve stimulation, hence parasympathetic activation, for treatment of heart~     failure is substantial.~      In this study, the safety and efficacy of a new vagus nerve stimulating system will be~     evaluated. This study will compare whether the new device improves Heart Failure parameters~     in Class II - III Heart Failure patients.~   "
236411|NCT00461006|"~     This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral~     antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2~     diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized~     to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and~     efficacy parameters will be assessed at intervals during the treatment period. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
236412|NCT00460993|"~     The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone),~     on older adults who reside in a nursing home and have poor sleep as determined by wrist~     actigraphy.~   "
236413|NCT00460980|"~     This study proposes evaluation of an educational tool, a laparoscopic virtual reality~     simulator. The purpose of this study is to determine whether training on the LapSim Simulator~     transfers to improved laparoscopic cholecystectomy operative performance in an animal model.~   "
236414|NCT00460967|"~     SUMMARY~      Age-related macular degeneration (AMD) is the leading cause of late onset visual impairment~     and legal blindness in people 65 years of age or older in the United States. It is a~     heterogeneous clinical entity in which retinal degeneration occurs predominantly in the~     macula in the context of aging and leads to impairment primarily of central visual acuity.~     The degenerative retinal eye disease occurs in two forms - a non-exudative dry form and an~     exudative wet form which in an individual patient may also represent stages of the disease.~     Non-exudative AMD accounts for 80-90% of AMD cases and it involves a constellation of~     clinical features that can include drusen, pigment clumping and/or retinal pigment epithelium~     (RPE) dropout, and geographic atrophy. Because of the overwhelming numbers of dry AMD~     subjects, the cumulative impact of this vision loss is significant.~      There is no effective therapy for maintaining or improving vision associated with dry AMD.~     The only therapy for persons with dry AMD is an oral supplement containing high doses of~     antioxidants and zinc, which was tested by the National Eye Institute in a large,~     multi-center, double-masked, sham-controlled clinical trial1. This antioxidant therapy was~     shown to modestly retard the progression of dry AMD from an intermediate stage to the~     advanced stages and confirmed the benefit of antioxidant therapy in this disease. There is~     currently no FDA-approved therapy for the treatment of subjects with dry AMD.~      Recently, the MIRA-1 modified per protocol population showed the effectiveness of~     Rheopheresis which is an application of selective therapeutic apheresis, namely double~     filtration plasmapheresis (DFPP) using a specifically designed filter for plasma filtration~     in subjects with non-exudative AMD. At one year the study reported with statistical~     significance (1) approximately a one line vision improvement in the Rheopheresis group versus~     no change in the Sham group and (2) 28% of subjects randomized to the active treatment~     gaining at least one line vision versus only 9% of subjects randomized to the sham treatment.~      With a total of 300 subjects with dry AMD and visual acuity of 20/40-20/100 inclusive, the~     current investigation plans to prove the effectiveness of the Rheopheresis treatment on a~     larger scale. Each subject will receive a series of 8 treatments (either active treatment or~     sham treatment in a 2:1 ratio) for a period of approximately 2.5 months. In addition, a~     post-treatment ophthalmic evaluation will be performed 2 weeks after the 8th treatment~     (approximately 3 months after the baseline visit) and at the 6, 9 and 12 month visits.~     Comparing the one-year proportions of at least a 10-letter gain in ETDRS LogMar BCVA from~     baseline, the current investigation will show the effectiveness of Rheopheresis treatment~     (compared to sham treatment) for treating dry AMD subjects. Other secondary effectiveness~     endpoints, including mean changes and proportions of BCVA better than 20/40 at one year, will~     be analyzed to support the main investigation.~   "
236415|NCT00460954|"~     The purpose of this clinical research study is to determine if different dosage regimens of~     Sinemet® CR (Carbidopa/levodopa) are dose proportional~   "
236416|NCT00460941|"~     This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different~     doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose~     of metformin. Patients will be randomized to receive either subcutaneous placebo, or~     subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to~     either 30mg or 40mg), weekly. All patients will continue on their existing metformin~     treatment regimen throughout the study. The anticipated time on study treatment is <3 months,~     and the target sample size is 100-500 individuals.~   "
236417|NCT00460928|"~     Neonatal lupus (NL) is the name given to a group of conditions that can affect the babies of~     mothers who have certain autoantibodies against components of the body's cells that are~     called SSA/Ro and SSB/La. NL can appear as a temporary rash that usually goes away by the~     time the baby is 6 months old, or very rarely an abnormal blood or liver condition that also~     improves with time - or it can cause permanent and often life-threatening damage to the fetal~     heart, known as congenital heart block (CHB). In women with anti-Ro/La antibodies who are~     pregnant for the first time, only about 2% of the babies will develop CHB. But for a woman~     who has already had a child with CHB or NL rash, the risk of CHB in her next pregnancy is~     nearly 20%. Unfortunately, once complete (third degree) heart block has been unequivocally~     identified in a fetus, it has never been reversed with any of the therapies that have been~     tried to date. Our previous studies strongly indicate that scarring of the conduction system~     (the heart's own natural pacemaker), a consequence of inflammation triggered by the~     mother's antibodies, damages or even destroys the cells that allow the heart to beat at a~     normal rhythm. Instead, the damaged heart beats extremely slowly, to an extent that is fatal~     to nearly 20% of affected babies (with most deaths occurring as fetal demises). Nearly all~     surviving children with CHB require permanent implantation of a pacemaker device. Because it~     is so difficult to treat or repair the damaged heart, a high-priority strategy is to try to~     prevent the inflammatory process before irreversible scarring can occur. The aim of this~     clinical-based proposal is to determine whether treating the pregnant mother with intravenous~     immune globulin (IVIG) will prevent the development of CHB.~   "
236418|NCT00460915|"~     Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on~     systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years.~      Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine~     on diastolic blood pressure (DBP) in Korean ISH patients aged 60 to 80 years~      To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through~     measurement of markers of inflammation.~   "
236425|NCT00460824|"~     Transplant rejection following organ transplant occurs because the recipient's immune system~     attacks the transplanted organ. The recipients immune system recognizes the transplanted~     organ as foreign tissue and attempts to destroy it in the similar way that it attempts to~     destroy infectious agents such as bacteria and viruses. The human leukocyte antigen (HLA)~     system is a set of genes that is responsible for controlling an individuals' ability to tell~     the difference between an infectious agent and self tissue.~      Differences in HLA genes between donors and recipients play a major part in influencing the~     rejection or acceptance of foreign tissue (i.e. transplanted organs). Due to time limitations~     in heart transplantation, HLA matching is not considered. It is unclear how individual HLA~     differences affect the recovery and expected lifespan of pediatric heart transplant~     recipients.~      This study is designed to look at the donor-recipient matching and mismatching to determine~     if mismatching leads to more complications, shorter graft survival and, therefore, increased~     risk of death following pediatric heart transplantation.~   "
236426|NCT00460811|"~     The purpose of this study is to determine the safety, efficacy, and dose response of a range~     of oral doses of linaclotide administered to patients meeting criteria for IBS-C.~   "
236427|NCT00460798|"~     This non-interventional study includes patients with advanced and/or metastatic renal cell~     carcinoma who are treated with SUTENT and who did not receive any other systemic therapy~     before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy~     and tolerability under conditions of routine use of Sutent. The individual observation period~     of each patient will be~      1 year.~   "
236428|NCT00460785|"~     The purpose of this study is to demonstrate bioequivalence of a new formulation to a~     reference~   "
236429|NCT00460759|"~     The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed,~     distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with~     rifapentine. Researchers believe that understanding how these tuberculosis drugs interact~     when given together may help to determine the best drug treatment plan for use in future~     studies. Volunteers will take moxifloxacin daily by mouth for the first part of the study and~     then moxifloxacin in combination with rifapentine during the second part of the study.~     Sixteen healthy men and women will be recruited from Johns Hopkins University School of~     Medicine to volunteer for this study. They will be required to stay in the inpatient unit~     twice, each time for 84 hours. Study procedures will include having a tube placed in a vein~     to draw several blood samples over time. Volunteers will participate in the study for a~     maximum of 48 days, including screening and follow-up visits.~   "
236430|NCT00460746|"~     The purpose of this study is to examine the safety, tolerability, and effectiveness of~     darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside~     Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by~     darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate~     enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are~     to remain unchanged.~   "
236431|NCT00460733|"~     The purpose of this study is to evaluate the efficacy and safety of risedronate sodium~     (Actonel®) after a wrist fracture in postmenopausal women.~   "
236432|NCT00460720|"~     The survey is designed to identify non-compliant Attention Deficit Hyperactivity Disorder~     (ADHD) patients who are currently on Immediate- Released Methylphenidate (IR-MPH) and observe~     any change in compliance after treating with other drugs intended to treat ADHD for over 3~     weeks~   "
236433|NCT00460707|"~     Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to~     test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy~     human subjects.~   "
236434|NCT00460694|"~     Cytokine-induced killer ( CIK ) cells have been shown by our lab to be cytolytic against both~     autologous and allogeneic acute myeloid leukemia ( AML ) cells. Large scale expansion of CIK~     cells has also been shown to be feasible in healthy allogeneic stem cell donors as well as in~     patients undergoing mobilization for autologous transplant.~      Donor lymphocyte infusion (DLI) has been shown to be active against some haematological~     malignancies including CML, AML, MDS,NHL and Hodgkin's disease. These donor lymphocytes can~     be further activated in vitro to become CIK cells. At least 2 other centers in the world have~     given allogeneic CIK cells for patients relapsing post allogeneic transplant for a variety of~     haematological malignancies. These early reports have demonstrated feasibility, absence of~     increased GVHD and possible efficacy in some cases.~      We are proposing a Phase I /II study on the feasibility / efficacy of immunotherapy with~     allogeneic CIK cells for patients who relapse after allogeneic marrow transplant for their~     haematological malignancies. These patients have to be either refractory to conventional~     donor lymphocyte infusion, or need a larger number of donor lymphocyte than could be provided~     by unmanipulated donor lymphocytes. Donor lymphocytes will be collected and cultured in GMP~     facilities to maturity, then infused into patients. This will be given in graded doses at 4~     weekly intervals and continued on in the absence of GVHD till remission is achieved or~     disease progression occurs. Patients may receive various forms of chemotherapy appropriate to~     the clinical condition in each case before the allogeneic CIK infusion.~      Efficacy will be assessed by comparing the response to allogeneic CIK infusion vs that to due~     to conventional DLI, ie response to the two different treatment using DLI response as the~     comparator. We expect about 10 such cases to be done over the next 3 years. Significant~     statistics is unlikely to be generated but observation and description of the response can~     generate useful information for presence or not of the efficacy of such a treatment.~      If clinical efficacy and superiority over conventional DLI is demonstrated, then future~     allogeneic CIK may take the place of DLI in this group of poor prognosis patients who relapse~     after allogeneic transplant .~   "
236435|NCT00460681|"~     The purpose of this study is to evaluate the clinical efficacy of thymopentin on the~     prevention of the recurrence and metastasis of small HCC after resection.~   "
236436|NCT00460668|"~     The purpose of this study is to evaluate the effects of an integrated multidisciplinary~     rehabilitation program on health related quality of life in the 12 months postoperative~     period in patients with an elective thoracotomy and to evaluate the effects of the program on~     general quality of life (SF-36), acute/chronic post-thoracotomy pain, impairment (changes in~     pulmonary function), disability (exercise capacity) and start to complete recovery (ECOG~     score of 0 or 1) 12 months postoperatively in patients with an elective thoracotomy.~   "
236437|NCT00460655|"~     This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with~     equinus deformity associated with post-stroke lower limb spasticity using the Modified~     Ashworth Scale (MAS) ankle score.~   "
236503|NCT00459797|"~     Patients presenting for elective surgery requiring orotracheal intubation will be randomized~     to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or~     the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.~   "
236504|NCT00459784|"~     The purpose of this study is to determine whether a specially developed Dementia Training~     Program for duos of general practitioners and primary care nurses is able to increase the~     number dementia diagnoses in elderly people living in the community and increase the~     adherence to clinical dementia guidelines~   "
236438|NCT00460642|"~     26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers~     (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical~     protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap~     Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD~     Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with~     ART treatment, and its usage decreases significantly the number of injections that the~     patient receives with treatment. The working hypothesis for this study is that the GnRH~     antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation~     in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the~     markedly fewer injections required.~   "
236439|NCT00460629|"~     Efforts to decrease the risk of GvHD by depleting T cells from the graft in CML patients have~     been complicated by an increased incidence of leukemia-relapse. Newer protocols using CD34+~     selected hematopoietic cells from matched-sibling donors and subsequent infusion of T cells~     in incremental doses to treat or avoid relapse of disease seem to be more promising. In this~     study, we try to further optimize this approach by the prophylactic infusion of cytotoxic T~     cells activated ex-vivo against leukemia-associated/specific antigens using peptide-pulsed~     dendritic cells.~   "
236440|NCT00460616|"~     Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and~     Parkinson's disease (2). There is evidence supporting a causal relationship between the~     occurrence of drug-induced restrictive valvular heart disease and treatment with pergolide~     (3): in several cases, the valvulopathy improved when pergolide was discontinued (4).~     Valvular heart damage has also been reported with the ergot-derived dopamine agonists~     bromocriptine and cabergoline (5,6).~      Two recent studies (7,8) have further demonstrated that both pergolide and cabergoline are~     associated with an increased risk of new cardiac valve regurgitation in patients treated for~     Parkinson's disease.~      The valvular abnormalities seen with ergot-derived dopamine agonists are similar to those~     observed in patients receiving ergot alkaloid agents (such as ergotamine and methysergide) in~     the treatment of migraine, or fenfluramine and dexfenfluramine in the treatment of obesity.~     These abnormalities also closely resemble carcinoid-related valvulopathies (9).~      Cardiac valve disease has never been reported in patients with prolactinomas who require~     treatment with dopamine-agonists even life-long (1). At variance with patients with~     Parkinson's disease, patients with prolactinomas are younger and are treated with an average~     dose of dopamine-agonists that is significantly lower (median bromocriptine dose 5 mg/day and~     median cabergoline dose 1 mg/week). Because of the young age of treatment beginning (most~     patients with microprolactinomas start dopamine-agonist treatment in early adulthood),~     treatment might be continued for over 3 decades: the cumulative risk of low doses of dopamine~     agonists for such a long period of treatment is currently unknown.~      To assess the prevalence of cardiac valve disease in patients treated with cabergoline, we~     wish to perform an echocardiography screening in a large representative sample of patients~     with prolactinoma who were treated with cabergoline for at least 12 months and in a group of~     control subjects recruited prospectively. We wish to evaluate the severity of regurgitation~     for the mitral, aortic, and tricuspid valves. Changes in cardiac valve apparatus was compared~     with treatment duration and cumulative cabergoline dose.~   "
236441|NCT00460603|"~     To determine the safety and efficacy of AG-013736 in combination with other standard of care~     medication in patients with first line metastatic colorectal cancer.~   "
236442|NCT00460590|"~     This study is designed to evaluate the safety of MVA85A in healthy volunteers in Cape Town.~     We have shown that MVA85A is safe and immunogenic in both a mycobacterially naïve population~     in the UK and in a more mycobacterially exposed population in The Gambia. The studies~     described here will be to assess the safety of MVA85A in 2 groups of adults, those with and~     without prior BCG vaccination. Once safety data has been obtained in these 2 groups, we will~     assess the safety of MVA85A in adolescents who have been previously vaccinated with BCG.~   "
236443|NCT00460577|"~     To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide~     plus Fenoterol in cumulative sequential doses in asthmatic children (5-<12 years) with acute~     bronchial obstruction attending emergency services~   "
236444|NCT00460564|"~     This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over~     placebo in patients with post-stroke upper limb spasticity of both the wrist and finger~     flexors using the Modified Ashworth Scale (MAS) wrist score.~   "
236445|NCT00460551|"~     The purpose of the study is to investigate if treatment with zalutumumab in combination with~     chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients~     with lung cancer compared to patients treated with chemo-radiation alone.~   "
236446|NCT00460538|"~     The purpose of the study is to determine weather Lectranal is effective in treatment of~     seasonal allergic rhinitis symptoms.~   "
236447|NCT00460525|"~     Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by~     mosquito bites. The purpose of this study is to compare the number of children who get~     malaria after receiving an experimental malaria vaccine (FMP2.1/AS02A) to the number of~     children who get malaria after receiving a vaccine for rabies (an approved vaccine that does~     not prevent malaria). The children will be assigned to one of the vaccine groups by chance.~     Participants and doctors will not know which vaccine was given. Study participants will~     include 400 children, ages 1-6 years, living in Bandiagara, Mali. Children will receive 3~     vaccine doses, by injection, to their upper arm. Study procedures will include physical exams~     and several blood samples. Participants will be involved in the study for 26 months.~   "
236448|NCT00460512|"~     The purpose of this study is to explore tolerability, safety and effectiveness of flexibly~     dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric~     disorder with symptoms of emotional instability, detachment from reality, often with~     delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated~     with an oral antipsychotic medication.~   "
236449|NCT00460499|"~     This study seeks to determine whether varying the dose of insulin and glucose in diabetic~     patients during coronary bypass surgery will improve outcomes in these patients.~   "
236450|NCT00460486|"~     The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5~     ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and~     second vaccinations being administered according to a rapid immunization schedule (12 ± 2~     days apart). The third vaccination will be administered approximately 6 months after the~     first dose.~   "
236451|NCT00460473|"~     The purpose of this study is to evaluate the efficacy and safety of perioperative use of~     dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery~     for fractured hip with general anesthesia.~   "
236452|NCT00460460|"~     The primary purpose of this study is to find out what the maximum tolerated dose is for an~     experimental drug called AZD4877 based on the side effects experienced by patients that~     receive AZD4877 on a weekly basis in these diseases.~   "
236505|NCT00459771|"~     Evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan vs placebo in~     prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer~     treated with trastuzumab.~   "
236453|NCT00460447|"~     Study Design:~      prospective phase II trial with 30 patients in 1 site~      Treatment Scheme:~      Option 1: Patient < 60 years of age with relapse after chemotherapy or > 12 months after~     hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day –21 Mylotarg 3 mg/ m² day –14~     Fludarabin 30 mg/ m² day –6 to –3 TBI 2x2 Gy day –3 to –2 (total dose 8 Gy) Tacrolimus (level~     adapted) from day –3 on Mycophenolat 2 x 1000 mg p.o. from day 0 to day 40 PBSC day 0~      Option 2: Patient > 60 years of age or younger patients < 12 Months after hematopoetic stem~     cell transplantation Mylotarg 6 mg/ m² day –21 Mylotarg 3 mg/ m² day –14 Fludarabin 30 mg/ m²~     day –3 to –1 TBI 1x2 Gy day 0 (total dose 2 Gy) Tacrolimus (level adapted) from day –3 on~     Mycophenolat 2 x 1000 mg p.o. from day 0 to 40 PBSC day 0~   "
236454|NCT00460434|"~     Pelvic organ prolapse is common among women with a prevalence that has been estimated to be~     as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal~     incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior~     randomized trial has shown that use of a Burch sling at the time of an abdominal~     sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an~     anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a~     vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse~     repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment~     with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal~     approach is effective in preventing urinary incontinence.~   "
236455|NCT00460421|"~     20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias~     receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body~     irradiation [TBI]) followed by hematopoietic stem cell transplant (HSCT). The study will~     evaluate the safety and pharmacokinetics of palifermin in pediatric patients. Three doses (40~     μg/kg/day, 60 μg/kg/day, and 80 μg/kg/day) are to be evaluated in each age group (1 to 2, 3~     to 11, and 12 to 16 years, respectively) using a conventional dose escalation design.~     Palifermin is administered for 3 consecutive days (Day -10 to Day -8, respectively) before~     the start of the conditioning regimen and for 3 consecutive days (Day 0 to Day +2) following~     HSCT. Patients will be enrolled simultaneously to each age group to identify a safe, well~     tolerated, efficacious dose in each age group. Patients will also be followed for secondary~     malignancies, progression-free survival (PFS) and overall survival (OS)~   "
236456|NCT00460408|"~     The study will provide additional safety data for specific safety events in persons receiving~     intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is~     interested in obtaining additional safety information when Macugen is used in real world~     settings by practitioners in Europe treating patients with neovascular (wet) age-related~     macular degeneration (AMD). The study will provide information about physician practice~     patterns and characteristics of patients treated with Macugen.~   "
236457|NCT00460395|"~     Study Objectives:~        -  To compare the survival (overall, systemic, and neurological) of patients with single~          cerebral metastases treated with either conventional surgical resection or stereotactic~          radiosurgery.~        -  To compare their rates of recurrence, complications, and their cognitive ability,~          functional status, and quality of life.~      Although surgical resection is a proven and effective treatment for brain metastases in~     patients with systemic cancer, stereotactic radiosurgery has been suggested to be equally~     effective and less morbid. Nonrandomized retrospective comparisons have been unable to~     resolve whether stereotactic radiosurgery is as effective as conventional surgery because of~     the complexity and variability of the population of patients with cancer and brain~     metastases. This controversy can only be resolved by a prospective randomized trial comparing~     these treatment modalities. Patients not randomized will be analyzed as a separate group.~   "
236458|NCT00460382|"~     The purpose of this study is to look at the safety and efficacy of a combination of 3 new~     antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have~     multi-resistant viruses and limited treatment options. An optimized background regimen that~     may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added,~     if possible, to this combination. Patients will undergo treatment for 48 weeks and~     virological efficacy will be evaluated at week 24.~   "
236459|NCT00460369|"~     Malaria is a life-threatening disease especially in small children. A high degree of~     Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this~     study is taking place. In the past few years, the recommendation for a first-line treatment~     in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing~     evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the~     study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT):~     artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be~     unsupervised.~      The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary~     outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the~     relationships between ACT PK data (day 3) and outcome.~      Expected total enrollment: 225 patients~      Study start: April 2007; expected completion: December 2007~   "
236460|NCT00460356|"~     This clinical trial studies glycoprotein and glycan in tissue and blood samples of patients~     with stage IB-IVA cervical cancer undergoing surgery to remove pelvic and abdominal lymph~     nodes. Studying samples of tumor tissue and blood from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and~     identify biomarkers related to cancer. It may also help doctors learn how far the disease has~     spread.~   "
236461|NCT00460343|"~     The purpose of this study is to determine the effectiveness of maximal support of community~     pharmacies to implement a pharmaceutical care model for establishing and - if necessary -~     improving adherence to antihypertensive medication in patients with medication-resistant~     hypertension.~   "
236462|NCT00460330|"~     The purpose of this study is to assess the cut-off value of GM/G test in Chinese patients~     after hematopoietic stem cell transplantation, and evaluate GM/G test and real-time PCR for~     diagnosis of IFI in Chinese patients.~   "
236463|NCT00460317|"~     To determine if treatment with AMG 706 (motesanib diphosphate) in combination with paclitaxel~     and carboplatin improves overall survival compared to treatment with placebo in combination~     with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects~     with adenocarcinoma histology (adenocarcinoma subpopulation).~   "
236465|NCT00460291|"~     If patients need to undergo bypass surgery, either an autologous vein can be used as bypass~     or, if there are no suitable veins are available, a prosthetic graft can be implanted.~     Varicose veins normally are judged not to be suitable as bypass. The ProVena vein support,~     made from polyester, is considered to strengthen varicose veins so that they they become~     suitable as bypass. Thereby, the advantages of an autologous bypass and the stability of~     polyester material can be combined.~      Patients that take part in the trial recieve an autologus bypass with a varicose vein, coated~     with ProVena. They are followed up at 3 and 6 months after implantation of a ProVena-coated~     bypass via duplex-sonography to assess the graft patency.~   "
236466|NCT00460278|"~     The purpose of this study is to evaluate the safety and tolerability of XL418 in subjects~     with solid tumors. XL418 is a new chemical entity that inhibits a spectrum of targets,~     including Akt and p70S6K, that mediate PI3 Kinase / PTEN signaling.~   "
236467|NCT00460265|"~     The purpose of this study is to determine the treatment effect of Panitumumab in combination~     with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or~     recurrent squamous cell carcinoma of the head and neck.~   "
236468|NCT00460252|"~     This is an open mono-centre randomised controlled trial performed at the Medical University~     Graz including a treatment visit (V1). In the treatment visit (V1) after admittance to the~     ICU arterial blood glucose values will be monitored and either the software-algorithm eMPC~     will be used to adjust the infusion rate of intravenously administered human soluble insulin~     to normalise arterial blood glucose or routine treatment will be used to establish tight~     glycaemic control. The treatment visit will last for 72 hours.~      The primary hypothesis of the study is that blood glucose control by the eMPC algorithm is~     not inferior compared to the implemented routine protocol.~   "
236469|NCT00460239|"~     This is a residential study that looks at the effects of buprenorphine in persons who abuse~     but are not dependent on opioids. Animal studies show that very high doses of buprenorphine~     produce less effects than mid-range doses. This suggests that buprenorphine can be a very~     safe medication. However, no studies in humans have tested higher doses in a similar way. The~     goal of this study is to show the effects of single doses of buprenorphine, across a range of~     doses, in persons who are not physically dependent on opioids (but do abuse opioids).~   "
236470|NCT00460226|"~     This is multi-center, prospective, observational stud. This study is designed to evaluate the~     rate of non-serious rash in Korean bipolar I patients.~   "
236471|NCT00460213|"~     The purpose of this study is to compare improvement percentage of urinary albumin excretion~     between valsartan 80 mg- and valsartan 160 mg-based therapy in patient with morning~     hypertension.~   "
236472|NCT00460200|"~     RATIONALE: Measuring levels of interleukin-6 and depression may help doctors understand the~     relationship between interleukin-6 and depression. It may also help the study of cancer in~     the future.~      PURPOSE: This clinical trial is studying depression and interleukin-6 production in patients~     with ovarian epithelial cancer.~   "
236473|NCT00460187|"~     Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of~     the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during~     carotid artery percutaneous intervention in high surgical risk patients.~   "
236474|NCT00460174|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop the tumor growth by~     blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor~     cells. Gemcitabine and bevacizumab may make tumor cells more sensitive to radiation therapy.~     Giving gemcitabine together with bevacizumab and radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     bevacizumab and abdominal radiation therapy works in treating patients with localized~     pancreatic cancer.~   "
236475|NCT00460161|"~     Phantom pain is a common complication following limb amputation, and is thought to result~     from a system of pathophysiological mechanisms - peripheral, spinal, central and~     psychological. Treatment is primarily medical, using antidepressant and anticonvulsant~     medications. At present, there is no evidence-based approach for the management of phantom~     limb pain (PLP). Acupuncture is an ancient Chinese treatment during which thin needles~     (diameter 0.20-0.30mm) are inserted into various points on the skin. Studies of this~     treatment have found significant benefit in a number of conditions with chronic pain.~      We propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether~     acupuncture is an effective and safe modality for preventing and reducing PLP in patients~     following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will~     be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups~     will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture~     treatment protocol, using either true or placebo needles at sham acupuncture points, for a~     period of four weeks (eight treatments).~      The primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical~     rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain~     (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck~     Depression Score. Blinding of the participants will be evaluated using a Validation of~     Blinding Questionnaire at the end of the treatment period.~   "
236476|NCT00460148|"~     This study in PD patients is designed to assess the affect food has on the absorption,~     distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted~     state and other patients following a high-fat breakfast), and to assess the difference in~     absorption, distribution, metabolism and excretion of ropinirole if patients are given three~     4mg ropinirole tablets versus one 12mg tablet.~   "
236477|NCT00460135|"~     Impact of resistance training in prepubertal children with obesity focusing mostly in changes~     in body composition and markers of insulin resistance.~      Hypothesis is that this will show positive changes in this randomized controlled trial.~   "
236506|NCT00459758|"~     To determine if electrical stimulation on acupoints has any effect on hypertensive subjects.~   "
249564|NCT00285883|"~     30 patients with poor antiretroviral therapy compliance will be identified from our pool of~     patients at Saint Michael’s Medical Center and be given Directly observed therapy.~   "
236478|NCT00460122|"~     This study will determine if transfusion of platelets containing HLA antibodies (certain~     antibodies to white blood cells) are more likely to cause transfusion reactions than~     transfusion of platelets that do not contain HLA antibodies.~      People 18 years of age or older who donate platelets at the NIH Clinical Center may be~     eligible for this study.~      An extra tube of blood (about one teaspoon) is obtained from participating donors at the time~     of their donation at the NIH Platelet Center. The blood plasma in the extra tube is tested~     for HLA antibodies and antibodies to certain white blood cells called granulocytes. The~     research sample is assigned a code number for identification and sent to the HLA Laboratory~     in the Department of Transfusion Medicine.~   "
236479|NCT00460109|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Combinations of biological~     substances in denileukin diftitox may be able to carry cancer-killing substances directly to~     cancer cells. Giving rituximab together with denileukin diftitox may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with denileukin~     diftitox works in treating patients with previously untreated stage III or stage IV~     follicular B-cell non-Hodgkin's lymphoma.~   "
236480|NCT00460096|"~     The primary purpose of this Phase II/III study is to demonstrate that Kamada-API, a new API~     concentrate manufactured by Kamada Ltd., is comparable to a currently marketed API product.~   "
236481|NCT00460083|"~     Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide~     two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a~     topical barrier repair cream designed to deliver special epidermal lipids to the top layers~     of the skin in order to correct skin barrier abnormalities found in atopic dermatitis.~     Epiceram does not contain corticosteroids or other conventional anti-inflammatory components~     and represents a novel class of skin barrier repair therapy for inflammatory skin disease.~      The objective of this study is to determine whether Epiceram is a safe and effective therapy~     for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel~     therapy.~   "
236482|NCT00460070|"~     Some antiepileptic drugs are found to have hormonal side effects. We want to study possible~     hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it~     to the older drugs; lamotrigine and carbamazepine. The participants are going to fill in a~     questionnaire and we will collect blood samples from them, to analyse hormones.~   "
236483|NCT00460057|"~     High bone turnover with the bone resorption exceeding bone formation is a major mechanism of~     postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach~     for the prevention. The Objective of the current study was to determine the short-term~     efficacy of once-weekly low dose alendronate in the prevention of bone loss in early~     postmenopausal Korean women with moderate bone loss via bone turnover markers.~      This study was a 12-week, randomized, double-blind clinical trial compared the effects of~     placebo with alendronate 20 mg once weekly. All subjects received supplemental calcium 600 mg~     and vitamin D 400 IU daily. Fifty two postmenopausal women (the ages between 50-65 year) with~     lumbar spine BMD at least 2.0 SD below the peak young adult mean were recruited at Eulji~     University Hospital, Daejeon, Korea. BMD was measured by DXA at baseline and serum alkaline~     phosphatase, osteocalcin and C-terminal telopeptide of type I collagen was measured at~     baseline and 12 weeks after treatment.~   "
236484|NCT00460044|"~     The purpose of this study is to study the relation between mechanical ventilation and ADMA~     concentrations at birth.~   "
236485|NCT00460031|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as~     ketoconazole, may stop the adrenal glands from making androgens. Lenalidomide may stop the~     growth of prostate cancer by blocking blood flow to the tumor. Giving ketoconazole and~     hydrocortisone together with lenalidomide may be an effective treatment for prostate cancer.~      PURPOSE: This phase II trial is studying how well giving ketoconazole and hydrocortisone~     together with lenalidomide works in treating patients with prostate cancer that did not~     respond to hormone therapy.~   "
236486|NCT00460018|"~     The primary aim of this study is to evaluate whether a lifestyle intervention of diet,~     exercise, and breastfeeding is associated with decreased postpartum weight retention and~     reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with~     gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma~     insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and~     breastfeeding duration.~   "
236487|NCT00460005|"~     Understanding the speed at which migraine headaches develop is of importance to patients.~     Determining the proportions in which different headache pain build-up occurs, may provide~     health care practitioners with valuable information with which to prescribe the most~     appropriate treatment. Patients who experience a slow pain build-up may gain more benefit~     from medications which have a slow onset of effect, high tolerability and long action.~     Conversely, medications with a rapid onset of effect may be of greater benefit to patients~     who experience rapid onset of migraine pain.~   "
236507|NCT00459745|"~     This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study~     with a 52-week open-label follow-up to evaluate the safety and efficacy of daily~     administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of~     both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia.~     There will be an open-label, 8-week, Selection Phase prior to randomization in which all~     patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if~     the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm,~     double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg~     or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg).~     The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which~     all patients will receive Pravafen.~      After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria~     will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen~     (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the~     completion of the 12-week double-blind phase of the study, all patients that haven't had~     changes in their well being, will be allowed to roll-over into the 52-week, open-label,~     follow-up portion of the study. During the 52 week, open label, Safety Phase of the study,~     all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160~     mg).~      Patients will be evaluated at baseline and every three weeks thereafter throughout the~     initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week,~     open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks.~      Participation in the study can be up to 72 weeks.~   "
236508|NCT00459732|"~     The purpose of this study is to test whether zinc can improve bone health in young patients~     with thalassemia.~   "
236509|NCT00459719|"~     The patients about to undergo liver transplantation will be randomized to one of the~     following two group:~      Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3~     months(12 weeks~   "
236488|NCT00459992|"~     This study will evaluate the effects of a drug called betahistine on appetite and food intake~     in overweight women. Betahistine has been used for many years to treat vertigo (dizziness).~     It was taken off the market in the United States in 1970 because it was thought to be~     ineffective for vertigo, but is still used for this purpose in many other countries. Some~     research suggests that betahistine may reduce appetite and food intake.~      Healthy overweight women between 18 and 50 years of age may be eligible for this study.~     Candidates must have a body mass index (BMI) between 30 and 40 and weigh less than 300~     pounds. They are screened with a medical history and physical examination, blood and urine~     tests, electrocardiogram (EKG), breathing test and eating behavior questionnaires.~      Participants are admitted to the NIH Clinical Center for a 3-day/2-night stay for the~     following procedures:~        -  Medication: Subjects take either betahistine (in one of three possible doses) or placebo~          capsules one time on the days of admission to the Clinical Center (day 1), three times~          on day 2 and two times on day 3.~        -  Blood tests and 24-hour urine collection.~        -  Resting metabolic rate: Subjects rest quietly for 1 hour after awakening and then rest~          again under a clear plastic hood or while wearing a face mask, breathing normally for~          about 25 minutes.~        -  DEXA scan to measure body fat, muscle, and bone mineral content: Subjects lie on a table~          above a source of X-rays while a very small dose of X-rays is passed through the body.~        -  Meal studies: Subjects food intake is measured on days 2 and 3.~        -  Questionnaires: Subjects complete questionnaires about how hungry or full they are~          feeling and rate how much they liked the foods they ate.~   "
236489|NCT00459979|"~     RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor~     and by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in~     treating patients with kidney cancer that cannot be removed by surgery.~   "
236490|NCT00459966|"~     Aim: The aim is to evaluate the outcome after spine surgery when using an integrated program~     that combined preoperative prevention and early postoperative rehabilitation compared to the~     routine procedures.~      Outcome measurements: Postoperative hospital stay, complications, function, pain, and patient~     satisfaction.~      Method: 60 patients scheduled for surgery for degenerative lumbar disease. The control group~     followed the routines in the department. The intervention group followed the integrated~     program consisting of preoperative prevention.~   "
236491|NCT00459953|"~     This study is designed to test the efficacy of an extended smoking cessation program for teen~     smokers. We hypothesize that teen smokers randomized to extended treatment will have a higher~     abstinence rate at 52 week follow-up than teen smokers receiving only open label treatment.~   "
236492|NCT00459940|"~     In the present double blind, placebo-controlled, parallel study we evaluated the impact of 12~     weeks thiazolidinedione (TZD) administration on basal and insulin-stimulated substrate~     metabolism in growth hormone-replaced adults with growth hormone deficiency.~   "
236493|NCT00459927|"~     The purpose of this study is to evaluate a new method of hemostasis, floseal gel, in~     tonsillectomy and adenoidectomy, with the goal of decreasing post operative and~     intraoperative morbidity.~   "
236494|NCT00459914|"~     A small number of uncontrolled studies have shown a high prevalence of sleep apnea in~     patients with refractory hypertension and that CPAP treatment achieves a significant~     reduction of blood pressure in the short term.~      The purpose of this study is to assess the prevalence of sleep apnea in patients with~     refractory hypertension, and the effects of continuous positive pressure treatment on~     systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.~   "
236495|NCT00459901|"~     To document the antitumor activity of capecitabine in combination with erlotinib in patients~     with previously untreated metastatic colorectal cancer. Time to tumor progression, objective~     response rate, time to confirmed response rate, duration of confirmed response rate, time to~     treatment failure, and CEA response will be assessed.~   "
236496|NCT00459888|"~     In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to~     treat their infrapopliteal arterial lesions will be collected. The treatment occurs strictly~     according the Instructions For Use of the CE-approved device (PolarCath Peripheral~     Dilatation System, Boston Scientific) and only data are collected that have been made~     available conform the Standard the Standards of Care for these patients.~   "
236497|NCT00459875|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     locally recurrent or metastatic kidney cancer.~   "
236498|NCT00459862|"~     This phase II trial is studying the side effects and how well pazopanib works in treating~     patients with malignant pleural mesothelioma. Pazopanib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
236499|NCT00459849|"~     Plaque radiotherapy is a common treatment for uveal melanoma. However, local failure has been~     reported in up to 20% of patients. We use intraoperative ultrasonography at plaque insertion~     and removal to evaluate plaque movement as a potential factor in local failure.~   "
236500|NCT00459836|"~     RATIONALE: Drugs used in chemotherapy, such as PR-104, docetaxel, and gemcitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given~     together with docetaxel or gemcitabine in treating patients with solid tumors.~   "
236501|NCT00459823|"~     Two-centre, open-label, non-randomized, dose-finding phase I study to determine the MTD of~     E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every~     28 days in patients with solid tumors, for whom therapy of proven efficacy does not exist or~     is not longer effective.~   "
236502|NCT00459810|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Estradiol may kill prostate cancer cells that no longer respond to hormone therapy.~     Giving paclitaxel poliglumex together with estradiol may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with~     estradiol works in treating patients with stage IV prostate cancer.~   "
236513|NCT00459667|"~     The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study~     the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and~     will further investigate the safety and tolerability profile of interferon beta 1b 500µg~     during longer-term treatment.~   "
236514|NCT00459654|"~     The purpose of this study is to evaluate the effectiveness of the investigational~     radioisotope Radium-223 in treatment of men with prostate cancer and bone metastases that no~     longer respond to hormonal treatment.~   "
236515|NCT00459641|"~     This is a randomised, controlled, open-label study of a single intralesional administration~     of I-040302 or a single bone marrow aspirate or a single steroid injection~     (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance~     imaging (MRI) in the diagnosis of a solitary bone cyst.~   "
236516|NCT00459628|"~     Tomotherapy is a new radiation therapy system that uses an integrated CT scanner during~     delivery of radiation treatment to improve the accuracy of the treatment. Furthermore the~     irradiation is delivered helicoidally allowing highly conformal shaping of dose distribution.~     However the magnitude of the clinical advantage of using the system in breast cancer is~     unknown. The purpose of the present study is to investigate whether or not the Tomotherapy~     can substantially reduce pulmonary and cardiac toxicities, as compared with conventional~     radiotherapy.~   "
236517|NCT00459615|"~     The purpose of this study is to compare four regimens using US FDA GMP intravenous artesunate~     for the treatment of uncomplicated Plasmodium falciparum malaria to identify the most~     effective treatment regimen as determined by rapidity of parasite clearance by microscopy.~   "
236518|NCT00459602|"~     The purpose of this study is to describe the outcomes of laparoscopic incisional hernia~     repair surgery and to record the outcomes of patients after surgery.~   "
236519|NCT00459589|"~     Older patients with cancer are poorly treated or not treated at all. A previous study in the~     south west of France (364 patients) showed that patients receiving chemotherapy had short~     survival times which strongly depended on nutritional status. In this study, the researchers~     would like to evaluate if individual dietician follow-up at each cycle of chemotherapy~     increases survival of patients at risk of undernutrition.~   "
236520|NCT00459576|"~     Infants will be enrolled in this study if they have never been diagnosed with asthma or~     wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of~     skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this~     study is to determine whether we can identify infants who will develop asthma.~   "
236521|NCT00459563|"~     Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after~     exposure to sunlight and is essential for maintaining normal calcium balance. One past study~     has suggested that vitamin D may be helpful for blood pressure. This study will test whether~     pills containing cholecalciferol (a form of vitamin D) or calcitriol (the active form of~     vitamin D) can treat high blood pressure. The investigators plan to enroll up to 80 subjects~     at the Atlanta VA Medical Center. Participation in the study is expected to last up to 4~     weeks. Subjects will be assigned to cholecalciferol, calcitriol or placebo). A 24-hour blood~     pressure monitor will be worn at the beginning and end of the study to determine blood~     pressure changes. Renin, PTH, angiotensin-II, and aldosterone levels will also be measured at~     the beginning and end of the study.~   "
236522|NCT00459550|"~     A study to investigate the safety and tolerability of both single and multiple intravenous~     administration of GSK933776 in patients with Alzheimer's Disease.~   "
236523|NCT00459537|"~     This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine~     hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in~     patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48~     weeks.~   "
236524|NCT00459524|"~     Primary Objectives:~        -  To compare the neuropsychiatric (NP) and neurocognitive (NC) symptoms and assess the~          quality of life (QOL) in older patients (age > 18) with acute myelogenous leukemia (AML)~          or high-risk myelodysplastic syndrome (MDS) receiving different therapies, chemotherapy~          (Clofarabine + ara-C) or targeted therapies (PKC412 + low-dose ara-C, or R115777 +~          low-dose ara-C, or decitabine, or STI + low-dose ara-C).~        -  To determine whether there is a correlation between the number of packed red blood cell~          (PRBC) transfusions and cognitive scores and/or QOL.~   "
236525|NCT00459511|"~     Hyperglycemia is frequent manifestations of the human metabolic response to systemic~     inflammatory response syndrome (SIRS),sepsis and septic shock, and are implicated in the~     clinical outcome.~      Adrenomedullin is elevated in SIRS, sepsis and septic shock and has been demonstrated the~     inhibitory role on insulin and adrenocorticotropic hormone secretion.~      Our hypothesis is that: AM elevation after SIRS could be the responsible to maintain~     hyperglycemia~   "
236526|NCT00459498|"~     The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter~     (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies~     of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was~     overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript~     levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16~     malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and~     immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of~     the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH~     as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100%~     of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS~     protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of~     benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein~     was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT.~     Association between low gene expression and strong cytoplasmatic immunostaining was found in~     50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene~     expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to~     its incapacity to migrate to cellular membrane.~   "
236738|NCT00456638|"~     The purpose of this study is to determine whether epidural Depodur alleviates the pain of~     OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and~     other tissue insults, as well as the induced inflammatory system and effects from prolonged~     ventilation in the ICU setting.~   "
236527|NCT00459485|"~     This is a double-blind, randomized controlled trial conducted in men 19-65 years of age who~     will receive daily zinc supplements (10 or 20 mg zinc/d as zinc sulfate) or placebo for 21~     days. Blood samples for plasma zinc and CRP concentrations will be drawn at baseline and days~     1, 2, 5, 9, 14, and 21 during supplementation and days 1, 2, 5, 9, and 14 after~     discontinuation of supplementation.~   "
236528|NCT00459472|"~     The purpose of this study is to compare outcomes of patients undergoing laparoscopic~     cholecystectomy before and after a laparoscopic training curriculum was implemented.~   "
236529|NCT00459459|"~     The purpose of this study is to investigate the relationship between prognosis and fine~     needle aspiration cytology character of papillary thyroid cancer.~   "
236530|NCT00459446|"~     This study will test how well a new contrast agent (dye) used in magnetic resonance imaging~     (MRI) can help visualize totally blocked arteries that normally supply blood to the neck,~     arms or legs. Currently used agents work well in visualizing normal or partly blocked~     arteries (arteries that have some blood flowing through them), but only poorly in totally~     blocked arteries. This study will see if a contrast agent called gadofosveset can better~     brighten images of completely blocked arteries. Gadofosveset is approved in Europe for use in~     MRI scans, but is still considered experimental in the United States.~      People 18 years of age or older with known or suspected total blockage of an artery to the~     neck, arm or leg may be eligible for this study.~      Participants undergo MRI scanning with gadofosveset contrast dye. MRI uses a magnetic field~     and radio waves to produce images of body tissues and organs. For this procedure, the subject~     lies on a table that can slide in and out of the tubular scanner, wearing earplugs to muffle~     loud noises that occur during the scanning process. The procedure lasts about 1.5 to 2 hours,~     during which the subject may be asked to hold his or her breath several times for as long as~     5 to 20 seconds. During the procedure, gadofosveset is injected and several kinds of MRI~     pictures are taken to understand better how the new agent works. Subjects may be asked to~     undergo a second scan using conventional MRI contrast dye~   "
236531|NCT00459433|"~     Complicated and expensive interventions are used to treat unspecific low back pain and the~     intervention is not always targeted the patients specific problems.It is therefore not~     surprising that a large fraction of unspecific low back pain patients do not respond very~     well to the usual biopsychosocial intervention.~      We would therefore like to identify the patients specific problems regarding the patients~     biomedical, psychological, and social needs.~   "
236532|NCT00459420|"~     Many patients with Parkinson's disease (PD) have sleep problems, including excessive~     sleepiness during the day. This is probably due to degeneration of sleep-regulating areas in~     the brain. At present, the only treatment for sleepiness in PD is modafinil, which is~     expensive and only partially effective. There is another potential treatment for sleepiness~     that is used worldwide, is inexpensive, well tolerated and safe - namely, caffeine. There~     have also been suggestions that caffeine may slow the progression of degeneration in PD,~     since coffee non-drinkers are at higher risk of developing PD. PD patients, even with severe~     sleepiness often do not use caffeine. It is unclear whether this is because their PD makes~     their sleepiness unresponsive to caffeine, because they cannot tolerate it, or whether this~     reflects their lifelong habit of non-use. This proposal outlines a trial in which patients~     with excessive sleepiness will be given caffeine or placebo (no therapy) in a blinded~     fashion. In this way, the effect of caffeine on sleepiness and motor symptoms can be directly~     analyzed. In addition, these findings can be used to test the tolerability of caffeine, to~     help plan a larger-scale study testing whether caffeine can slow the progression of PD~   "
236533|NCT00459407|"~     Green tea extract contains ingredients that may prevent or slow the growth of prostate~     cancer. This phase I trial is studying how well green tea extract works in treating patients~     with prostate cancer undergoing surgery to remove the prostate~   "
236534|NCT00459381|"~     This phase II trial is studying the side effects and how well pazopanib works in treating~     patients with recurrent glioblastoma. Pazopanib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor~   "
236535|NCT00459368|"~     The purpose of this study is to determine whether providing patient medication adherence~     information on inhaled corticosteroid use to clinicians will result in improved patient~     adherence and asthma control.~   "
236536|NCT00459355|"~     The purpose of this study was to test the effectiveness of a new multimodal educational~     intervention to improve home safety for persons with dementia of the Alzheimer's type and~     their home caregivers.~   "
236537|NCT00459342|"~     Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. This phase II trial is studying how well dasatinib works in treating patients with~     stage IIIB, stage IV, or recurrent non-small cell lung cancer.~   "
236538|NCT00459329|"~     The purpose of this study is to test the effectiveness of a home-based depression treatment~     intervention called Program to Encourage Active, Rewarding Lives (PEARL). We hypothesize~     that over a 12-month period, compared to usual care, those receiving the PEARL intervention~     will show more improvement with their depression, have higher quality of life and function,~     and use fewer medical services.~   "
236539|NCT00459316|"~     Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States.~     This disease can be treated by antibiotics, but mortality rates associated with meningitis of~     up to 53% have been estimated. Vaccination against meningitis may be effective in preventing~     this disease, especially for HIV-infected youth who have weakened immune systems. The purpose~     of this study was to determine the safety of and immune response to a preventive meningitis~     vaccine in HIV-infected youth.~   "
236540|NCT00459303|"~     This study is to compare intraindividually the functional vision provided by two different~     posterior chamber intraocular lenses: AMO Tecnis Z9000 and Alcon SA60AT Acrysoft. To see if~     the aspherical intraocular lenses provide better functional vision than traditional spherical~     intraocular lenses.~   "
236541|NCT00459290|"~     RATIONALE: Progesterone can cause the growth of ovarian epithelial cancer , primary~     peritoneal cancer, or fallopian tube cancer. Hormone therapy using mifepristone may fight~     ovarian epithelial cancer and primary peritoneal cancer by lowering the amount of~     progesterone the body makes.~      PURPOSE: This phase II trial is studying the side effects and how well mifepristone works in~     treating patients with recurrent or persistent ovarian epithelial cancer, primary peritoneal~     cancer, or fallopian tube cancer.~   "
236542|NCT00459277|"~     Cancer patients taking regular medication for their pain often still have episodes of severe~     pain that 'break through' despite their background pain treatment. Fentanyl is a strong,~     short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains~     fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal~     spray. This study will test the efficacy and safety of Nasalfent in the treatment of~     breakthrough cancer pain.~   "
236543|NCT00459264|"~     The purpose of this study is to determine whether daily folic acid supplements can prevent~     new episodes of mood disorder in young people (aged 14-24 years) of biological parents with~     current or past history of depression or bipolar disorder.~   "
236544|NCT00459251|"~     This main purpose of this study is to understand the difference and distribution of~     drug-metabolizing enzyme genetic polymorphisms among Taiwan ethnicities. The subjects of~     study include Atayal, Pawlan, Yami, Tsou, Ami, Minnan and Hakka. We anticipate establishing a~     reference for the clinical medication in various ethnic groups according to the difference~     and distribution of the genetic polymorphisms.~   "
236545|NCT00459238|"~     RATIONALE: Telephone-based cancer education and counseling may help participants learn about~     ways of preventing cancer and choose a lifestyle that will help them stay healthy as they~     grow older.~      PURPOSE: This randomized clinical trial is studying telephone-based cancer education and~     telephone-based counseling to see how well they work compared with telephone-based cancer~     education alone in young participants.~   "
236546|NCT00459225|"~     Anemia is a common disorder in infants with one working chamber of the heart that pumps~     blood. Anemia is when the level of healthy blood cells becomes too low. This may cause other~     health problems because red blood cells contain hemoglobin, which carries oxygen (needed for~     survival) to different parts of the body.~      This study will look at the role of iron in preventing anemia in infants with one pumping~     chamber. The importance of iron therapy will be examined.~      Hypothesis: Prophylactic use of iron in infants with single ventricle is effective in~     preventing anemia.~   "
236547|NCT00459212|"~     This phase I trial is studying the side effects and best dose of GTI-2040 in treating~     patients with relapsed, refractory, or high-risk acute leukemia, high-grade myelodysplastic~     syndromes, or refractory or blastic phase chronic myelogenous leukemia. Drugs used in~     chemotherapy, such as GTI-2040, work in different ways to stop the growth of cancer or~     abnormal cells, either by killing the cells or by stopping them from dividing.~   "
236548|NCT00459186|"~     The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel~     plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I).~      Once an appropriate dose is reached, the purpose then will be to determine the response rate~     of docetaxel plus RAD001 (Phase II).~   "
236549|NCT00459173|"~     The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg~     and 20 mg) for the maintenance of abstinence from smoking.~      Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the~     clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month~     treatment period and to evaluate the pharmacokinetics of the drug.~   "
236550|NCT00459160|"~     The goal of this study will be to determine if a lower than normal blood pressure during~     surgery for bleeding in the abdomen or chest will result in decreased bleeding and decreased~     chance of death.~   "
236551|NCT00459134|"~     RATIONALE: L-arginine supplements may improve the quality of life and sexual function in~     women who are cancer survivors.~      PURPOSE: This randomized clinical trial is studying an L-arginine supplement to see how well~     it works compared with a placebo in treating women who are cancer survivors.~   "
236552|NCT00459121|"~     RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving vandetanib together~     with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving vandetanib together with carboplatin~     and paclitaxel works in treating patients with stage I, stage II, or stage III non-small cell~     lung cancer that can be removed by surgery.~   "
236553|NCT00459108|"~     This phase II trial is studying how well dasatinib works in treating patients with advanced~     liver cancer that cannot be removed by surgery. Dasatinib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
236554|NCT00459082|"~     Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous~     infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac~     surgery and require tracheal intubation with mechanical ventilation in the post-operative~     period. Three bolus and infusion dose will be administered to a total of 36 patients.~   "
236555|NCT00459069|"~     The main purpose of this study is to test the safety of dendritic cell tumor fusion study~     vaccine and to determine the type and severity of any side effects associated with this study~     vaccine. Cancer cells have unique markers that distinguish them from normal cells of the~     body. These markers can potentially serve as targets for the immune system. Dendritic cells~     are normally found in small amounts in the body and are responsible for immune responses~     against foreign substances that enter the body. Animal studies have shown that these fused~     cells can stimulate powerful anti-tumor responses.~   "
236556|NCT00459056|"~     The purpose of this study is to compare the effects of two different combination therapies~     for high blood pressure on vascular health.~   "
236594|NCT00458510|"~     Cancer patients taking regular medication for their pain often still have episodes of severe~     pain that 'break through' despite their background pain treatment. Fentanyl is a strong,~     short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains~     fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal~     spray. This study will examine the long-term safety of Nasalfent in the treatment of~     breakthrough cancer pain.~   "
236630|NCT00458042|"~     The purpose of this study is to compare the effects of switching from inhaled Ventavis to~     intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis~     therapy. This study is intended to provide information on the safe transition from Ventavis~     to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life~     and treatment satisfaction compared to Ventavis.~   "
236557|NCT00459043|"~     In this research study, the researchers are comparing the combination of docetaxel and~     Zactima with docetaxel alone to see if the combination of the two drugs will be more~     effective than docetaxel alone. Zactima blocks the actions of three substances in the body:~     1)vascular endothelial growth factor reception (VEGFR); 2)epidermal growth factor receptor~     (EGFR); and 3) rearranged during transfection (RET). VEGFR stimulates the growth of new blood~     vessels. When certain proteins bind to the VEGF receptor, a process begins to occur which~     allows new blood vessels to be made that provide blood to the cancer cells. Zactima is~     thought to block these proteins from binding to the VEGF receptor, which would then block the~     process that creates new blood vessels. EGFR controls how quickly cells grow and multiply.~     RET is thought to have a particularly significant role in the development and growth of~     squamous cell tumors. The actions of Zactima are very different from the way standard~     chemotherapy drugs work. Researchers believe that Zactima might have different side effects~     from other cancer treatments so another one of the purposes of this study is to assess the~     side effects caused by the drug.~   "
236558|NCT00459030|"~     RATIONALE: Finding out which communication method affects a participant's decision to undergo~     colorectal cancer screening may help increase the number of participants who undergo~     screening. It is not yet known which communication method is more effective in increasing how~     often participants undergo colorectal cancer screening.~      PURPOSE: This randomized clinical trial is studying traditional print communication methods~     to see how well they work compared with simple electronic communication methods or usual care~     in increasing how often older women undergo colorectal cancer screening.~   "
236559|NCT00459017|"~     Despite knowledge regarding the importance of controlling patients' blood pressure (BP) only~     30% of treated patients achieve BP goals. Our objective was to determine the effect of~     frequent self measurements of BP in the patients' natural environment as a mean to improve BP~     control. Our hypothesis was that frequent measurements of BP will reduce mean BP levels.~   "
236560|NCT00459004|"~     The primary objective is to verify the dose-response relationship of rimonabant on body~     weight change.~      The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body~     weight loss and on secondary criteria associated with comorbidities, and to evaluate the~     safety and the pharmacokinetics of SR141716.~   "
236561|NCT00458991|"~     The purpose of the study is to understand the effect of rhGH therapy on hepatic drug~     metabolism in children with idiopathic growth hormone deficiency.~   "
236562|NCT00458978|"~     This phase II trial is studying how well cediranib maleate works in treating patients with~     recurrent or newly diagnosed metastatic head and neck cancer. Cediranib maleate may stop the~     growth of head and neck cancer by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the tumor.~   "
236563|NCT00458952|"~     The purpose of this study is to determine whether iobenguane I 131 is safe and effective in~     patients with malignant pheochromocytoma or paraganglioma.~   "
236564|NCT00458926|"~     Non-invasive positive pressure ventilation (NIV) refers to the provision of mechanical~     ventilation without an artificial airway (for example, an endotracheal tube). Over the past~     decade, evidence from randomized control trials has accumulated to demonstrate effectiveness~     of the technique in avoiding intubation, reducing complications associated with intubation,~     shortening ICU and hospital lengths of stay, and reducing mortality rates in selected~     patients with acute respiratory failure. However, NIV is still underutilized at many medical~     centers. The purposes of this project will be to acquire information related to NIV use, to~     identify reasons for underutilization, to implement interventions that encourage more~     appropriate use of NIV, and to evaluate the effectiveness of the interventions. Reliable~     information on NIV use as well as analysis of reasons for underutilization will provide~     insight into ways of enhancing NIV use. We will determine utilization rate, technology used,~     patient diagnoses, duration of ventilator use and hospital stay, and success rates as~     recorded on case report forms (CRFs). After completing the survey, we will provide an~     educational program to randomly selected institutions (one-half of the total) aimed at~     increasing the knowledge and skill of physicians, nurses, and therapists regarding use and~     implementation of NIV. Data will be gathered for a second round with the same data-gathering~     instruments used during~   "
236565|NCT00458913|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving bortezomib together with~     cisplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib~     together with cisplatin works as first-line therapy in treating patients with malignant~     mesothelioma.~   "
236566|NCT00458900|"~     In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous~     administrations. As moxifloxacin is known to have a high oral bioavailability in healthy~     volunteers, patients are switched to oral or enteral therapy as soon as possible. However, no~     data on plasma levels for moxifloxacin during such a switch-therapy in IC-patients are~     available. Therefore, this study aims to evaluate the moxifloxacin-plasma levels and their~     inter-individual variability during IV to enteral switch therapy in IC-patients.~   "
236567|NCT00458887|"~     RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may~     improve the ability to plan cancer treatment and may help patients live more comfortably.~      PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with~     cisplatin.~   "
236568|NCT00458874|"~     The purpose of this study is to determine whether knowledge of abnormal results from a~     noninvasive test for detection of subclinical atherosclerosis (carotid intima media thickness~     [CIMT]), in addition to knowledge of cardiovascular disease (CVD) risk factors, enhances~     adherence to healthy lifestyle behaviors in comparison to only CVD risk factor knowledge. We~     believe that participants with CVD risk factors who have knowledge of their own CIMT test~     results showing significant subclinical atherosclerosis will demonstrate better adherence to~     therapeutic lifestyle change (TLC) than those subjects from whom the CIMT test information is~     withheld.~   "
236569|NCT00458861|"~     This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given~     subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who~     have previously had an inadequate response to treatment with anti-tumor necrosis factor~     (anti-TNF) therapy.~   "
236570|NCT00458848|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A~     peripheral stem cell transplant may be able to replace blood-forming cells that were~     destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may~     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral~     stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.~      Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL~     patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will~     be implemented in patients pertaining to this category.~   "
236571|NCT00458835|"~     The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™~     (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide~     HFA-metered-dose inhaler (MDI). The administration of the study medication will be as~     follows: three single doses, separated by a wash-out period. The study will provide further~     data on the safety and tolerability of ciclesonide.~   "
236572|NCT00458822|"~     The purpose of this study in patients needing treatment for AL amyloidosis is to see how well~     treatment with IV melphalan works and then, if some clonal plasma cells are still present~     about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and~     dexamethasone works to reduce the rest of the clonal plasma cell disease.~   "
236573|NCT00458809|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body~     temperature. Adding chemotherapy to hyperthermia and infusing it directly into the abdomen~     may kill more tumor cells. Giving this treatment after surgery may kill any tumor cells that~     remain after surgery.~      PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal~     hyperthermic perfusion with oxaliplatin in treating patients with stage IV peritoneal cancer~     due to appendix cancer or colorectal cancer.~   "
236574|NCT00458796|"~     RATIONALE: Zoledronic acid may help decrease the risk of broken bones, bone pain, and other~     symptoms caused by bone metastases. It may also help patients live more comfortably.~      PURPOSE: This randomized clinical trial is studying different schedules of zoledronic acid to~     compare how well they work in treating patients with breast cancer that has spread to the~     bone.~   "
236575|NCT00458783|"~     The purpose of this study is to determine whether length of storage of RBC is related to~     postoperative morbid outcomes in patients undergoing cardiac surgery.~   "
236576|NCT00458770|"~     Cluster headache is characterized by unilateral excruciating head pain and autonomic~     dysfunction. Hypothalamic overactivity was observed in nitrate-induced cluster-headache and~     in only one case of spontaneous cluster headache 'Sprenger et al, 2004). This prompted the~     application of hypothalamic deep brain stimulation. The aim of this data is to precise the~     localisation of the hypothalamic activation.~   "
236577|NCT00458757|"~     In this study, we wish to find behavioral evidence for the question whether an amputation of~     the arm can lead to changes in visual perception or motor responses to objects in~     peripersonal space. We hypothesize that changes in the motor and somatosensory hand-related~     cortices following amputation might lead to changes in parietal hand-related areas. The~     consequence of these parietal changes should be reflected behaviorally in reduced~     perception/attention/responses to hand-related objects in the space ipsilateral to the~     amputation. We further hypothesize that the use of prosthetics may provide the necessary~     visual feedback to maintain an intact hand representation and therefore lead to lesser~     cortical reorganization in both visual and somatosensory cortical areas.~   "
236578|NCT00458744|"~     RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of talotrexin in~     treating young patients with recurrent solid tumors or leukemia that is recurrent or does not~     respond to treatment.~   "
236579|NCT00458731|"~     This phase I trial is studying the side effects and best dose of bevacizumab and cediranib~     maleate in treating patients with metastatic or unresectable solid tumor, lymphoma,~     intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma. Monoclonal antibodies, such~     as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer~     cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Cediranib maleate may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Bevacizumab and cediranib maleate may also stop the~     growth of cancer cells by blocking blood flow to the cancer. Giving bevacizumab together with~     cediranib maleate may kill more cancer cells.~   "
236580|NCT00458718|"~     The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus~     nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo~     patch on abstinence from smoking in cigarette smokers motivated to quit.~      Secondary objectives are to evaluate the clinical and biological safety of rimonabant~     associated with nicotine replacement therapy during a 9-week treatment period and to evaluate~     the effect of the combination on weight and craving.~   "
236581|NCT00458705|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride~     liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either~     by killing the cells or stopping them from dividing. Thalidomide may stop the growth of~     cancer cells by blocking blood flow to the cancer. Giving bortezomib together with~     doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide, dexamethasone,~     and bortezomib may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib~     together with doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide~     and dexamethasone with or without bortezomib works in treating patients with multiple~     myeloma.~   "
236797|NCT00455858|"~     This trial is conducted in Asia. This trial aims for evaluating the glycaemic control,~     measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to~     oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.~   "
236582|NCT00458679|"~     We would like patients to be in a research study to determine the safety and effectiveness of~     special cells that may make their own immune system fight their cancer.~      To do this, we will put a special gene into cancer cells that have been taken from the~     patients body. This will be done in the laboratory. This gene will make the cells produce~     interleukin 2 (IL-2), which is a natural substance that may help their immune system kill~     cancer cells. Additionally, we will stimulate the cancer cells with normal embryonic~     fibroblasts (cells that develop into normal connective tissues in the body) so that they will~     make another natural protein called CD40 ligand (CD40L). Studies of cancers in animals~     suggest IL-2 performs better when mixed with CD40L.~      Some of these cells will then be put back into the patients body with the goal that they will~     act like a vaccine and stimulate their immune system to attack the CLL cells. Studies of~     cancers in animals and in cancer cells that are grown in laboratories suggest that combining~     substances like IL-2 and CD40L with cancer cells help the body recognize and kill cancer~     cells. We have already conducted a study similar to this in patients with CLL. In that study,~     the subjects received about three months of injections (shots). In those subjects we saw some~     changes in the subject's immune system that might indicate that the modified cells were~     helping their immune system fight the cancer. However, in most of the subjects this change in~     the immune system went away after the injections were stopped.~      In this study we want to see if we can make the change in the immune system last longer by~     giving more injections over a longer period of time. We hope that this might produce a better~     response directed at the CLL cells. We will also be looking at the effect on cells called~     cancer stem cells which grow into the CLL cells we see in the blood. Specifically, this study~     will allow subjects to receive the injections for up to one year.~   "
236583|NCT00458666|"~     Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused~     by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains~     coagulation activators, their role during pregnancy has not been elucidated. The current~     study aimed to evaluate coagulation parameters in AF during human pregnancy.~   "
236584|NCT00458653|"~     The main purpose of this study is to test the safety and determine the type and severity of~     any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous~     transplant for patients with multiple myeloma. Autologous stem cell transplantation is a~     standard therapy for multiple myeloma that is often successful in significantly decreasing~     the amount of cancer. However, it is not a cure because at some point the multiple myeloma~     generally begins to grow again. Cancer vaccines are investigational agents that try to~     stimulate the immune system to recognize and fight against cancer cells. One type of cancer~     vaccine uses an immune stimulating cell of the body known as a dendritic cell. Research has~     shown that these dendritic cells can stimulate an immune response against the tumor.~   "
236585|NCT00458627|"~     In our previous study of Methacholine Challenge Tests (MCT) in preschool children, we found~     that wheeze detection was associated with significant reduction in flows and vital capacity~     values. We hypothesized that this finding is associated with trapped-air rather than the~     children's loss of cooperation/concentration.~      Objectives: To test this hypothesis by attempting plethysmography measurements during MCT.~   "
236586|NCT00458614|"~     The disposition of a number of drugs has been reported to be altered in patients with Cystic~     Fibrosis (CF). Changes in pharmacokinetic parameters observed included increased volumes of~     distribution and increased clearance of renally eliminated drugs. The purpose of this this~     study is to characterize the pharmacokinetics of IV lansoprazole and its metabolites in~     normal healthy children and children with Cystic Fibrosis (CF) ages 2 to < 10 years. It is~     suspected that children with CF will have a more rapid clearance as compared to healthy~     children.~   "
236587|NCT00458601|"~     This study is designed to evaluate the clinical activity of CDX-110 vaccination when given~     with standard of care treatment (maintenance temozolomide therapy). Study treatment will be~     given until disease progression and patients will be followed for long-term survival~     information. Efficacy will be measured by the progression-free survival status at 5.5 months~     from the date of first dose.~   "
236588|NCT00458588|"~     RATIONALE: The amount and type of fat in the diet may affect hormone levels, bone mineral~     density, and breast density later in life. This may affect the risk of developing breast~     cancer. Learning about the long-term effects of diet on hormone levels, bone mineral density,~     and breast density may help the study of breast cancer in the future.~      PURPOSE: This clinical trial is studying the long-term effect of adolescent diet on hormones~     and breast cancer risk in women previously enrolled in the Dietary Intervention Study in~     Children.~   "
236589|NCT00458575|"~     The main purpose of this study is to evaluate the preliminary safety and immunogenicity~     (ability of an antigen to provoke immune response in the human body) of CNTO 2476,~     administered subretinally, in participants with advanced retinitis pigmentosa (RP; disease of~     the eye that leads to loss of vision and blindness) with either light perception only (LP) or~     hand motion (HM).~   "
236590|NCT00458562|"~     RATIONALE: Finding certain changes in genes may help doctors predict which patients are at~     risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may~     help the study of cancer in the future.~      PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of~     developing cervical intraepithelial neoplasia or invasive cervical cancer.~   "
236591|NCT00458549|"~     RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One~     type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect~     the growth of prostate cancer.~      PURPOSE: This randomized clinical trial is studying polyunsaturated fatty acids in treating~     patients with prostate cancer undergoing prostate biopsy and/or surgery.~   "
236592|NCT00458536|"~     The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study~     vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony~     Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any~     side effects associated with this study vaccine. GM-CSF is similar to a substance in the body~     that stimulates the production of white blood cells. To create the study vaccine, cells will~     be removed from the participants tumor and fused with dendritic cells which are obtained from~     the participants blood. Dendritic cells are responsible for immune responses to foreign~     substances that enter the body. Animal studies have shown that these fused cells can~     stimulate powerful anti-tumor responses.~   "
236593|NCT00458523|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them.~      PURPOSE: This phase II trial is studying the side effects and how well alemtuzumab works in~     treating patients with B-cell chronic lymphocytic leukemia in partial remission or complete~     remission.~   "
236798|NCT00455845|"~     this study is to determine whether the frequency and severity of pelvic pain or dysmenorrhea~     are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after~     operative laparoscopy compare with those treated with laparoscopic surgery only~   "
236595|NCT00458497|"~     This study is designed to assess the effects of socks and bedding materials on foot pain, the~     level of blood oxygen existing in the feet and quality of sleep in subjects who have chronic~     foot pain from either diabetic neuropathy or other conditions, e.g., peripheral arterial~     disease, regenerative joint disease). The three main hypotheses to be tested are: 1)compared~     to placebo socks, subjects wearing Holofiber socks experience reduction in foot pain,~     2)compared to placebo bedding, subjects sleeping in beds lined with a Holofiber mattress pad~     experience improved quality of sleep and 3) compared to placebo socks, subjects who wear~     Holofiber socks will have increased blood oxygenation levels in their feet.~   "
236596|NCT00458484|"~     RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal~     tissue.~      PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic~     radiosurgery and to see how well it works in treating patients with kidney tumors who are~     poor candidates for surgery.~   "
236597|NCT00458471|"~     The overall goal of this project is to develop a new approach for the prevention of urinary~     tract infection (UTI) in persons who rely on indwelling catheters for bladder drainage.~     Veterans with spinal cord injury (SCI) frequently require chronic bladder catheterization.~     Most individuals with SCI have neurogenic bladders, and the resulting urinary stasis and~     bladder catheterization predispose them to recurrent UTI.1 The presence of a urinary catheter~     dramatically increases the risk of UTI, not only through contamination of the urinary tract~     during catheter changes, but also by the presence of a foreign body in the urethra and~     bladder. Implanted urinary catheters rapidly acquire a complex, three-dimensional biofilm~     composed of bacteria, their extracellular products, and components deposited from bodily~     fluids. The pathogenic organisms in a biofilm continually seed the bladder, leading to~     bacteriuria and/or UTI.2 Bacterial interference, or using benign bacteria to prevent~     infection with virulent pathogens,3, 4 may offer a solution to the significant problem of~     recurrent episodes of UTI in persons with indwelling catheters. Since biofilm formation on a~     wet implanted device such as a urinary catheter is nearly impossible to prevent,5, 6 we~     propose instead to manipulate the adherent microbial flora. We propose that inserting urinary~     catheters than have been pre-inoculated with a benign strain of Escherichia coli (83972) will~     be an efficient means to colonize the neurogenic bladder with this harmless organism. If~     successful colonization is achieved in this pilot trial, a larger clinical trial will be~     designed to test the efficacy of this approach to prevent bladder colonization by pathogenic~     organisms and thus to prevent UTI.~   "
236598|NCT00458458|"~     (A) Major 1) to compare the effectiveness of norethindrone acetate (NA) with GnRH agonist~     (Lupron-Depot-3) in relieving symptoms of endometriosis, 2) to compare bone density in the~     two treated groups in order to demonstrate that NA does not affect bone density; (B) Minor:~     1) To compare the lipid profiles of patients in the two groups to confirm the hypothesis that~     the effects of NA and GnRH agonists on lipid profiles are similar, 2) To determine whether~     quality of life, assessed by questionnaire, is better in patients assigned to NA than in~     patients assigned to GnRH, 3) To determine whether NA has fewer adverse effects than GnRH~     agonist.~   "
236599|NCT00458445|"~     The purpose of this study is to determine whether SPD465 is safe and effective in the~     treatment of ADHD in young adult drivers after a duration of 16 hours.~   "
236600|NCT00458432|"~     This study uses magnetic resonance imaging (MRI) to explore the areas of the brain involved~     in different types of mental processes, in particular, the brain regions involved in~     perception, recognition, learning, and memory. MRI uses a magnetic field and radio waves to~     produce images of body tissues and organs. In this study it is also used to measure blood~     flow in different regions of the brain while the subject is presented auditory or visual~     stimuli. The subject lies on a table that can slide in and out of the scanner (a narrow~     cylinder), wearing earplugs to muffle loud noises that occur during the scanning process.~     Subjects are in the scanner no more than 2 hours.~      Healthy, right-handed normal volunteers between 20 and 40 years of age who have at least a~     high school education may be eligible for this study.~      While undergoing MRI, participants are presented visual stimuli (pictures or geometric shapes~     on a projection screen) or auditory stimuli (tones played through a set of headphones).~     Unpleasant stimuli such as loud noise, electric shocks, heat, or tactile stimuli are~     administered occasionally. The intensity of these stimuli is similar to those experienced in~     practice sessions before the scanning. Participants receive between 30 and 60 visual or~     auditory stimuli during the scanning session, and each stimulus lasts about 1 second. In some~     studies participants are asked to move a joystick that controls a rating bar presented on a~     projection screen to indicate when they expect to receive these stimuli and how sure they are~     that they will occur. Heart rate, respiration rate, and sweat gland activity are monitored~     during the MRI sessions, using electrodes placed on the fingers to measure heart rate and~     sweat gland activity and a sensor strapped around the chest to measure respiration. Subjects~     are in the scanner no more than 2 hours.~      Following the experiment, subjects may be asked questions about their experiences during the~     study.~   "
236601|NCT00458419|"~     Endorphins are naturally occurring narcotic substances that are released when individuals~     perform exercise. The hypothesis of the study is that endorphins reduce the severity of~     breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD).~     The initial five visits include familiarization and validation of a computerized system for~     patients to report dyspnea and leg discomfort continuously during exercise testing.~      At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end~     exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5~     minutes prior to exercise in a double-blinded design. The primary outcome is the slope of~     oxygen consumption - dyspnea.~   "
236602|NCT00458406|"~     Context: The obstructive sleep apnea syndrome (OSAS), i.e., snoring with difficulty breathing~     during sleep, is common in children. Continuous positive airway pressure (CPAP) therapy is~     the usual treatment for children who do not improve following surgery. However, CPAP is~     uncomfortable and is often not tolerated. We therefore plan to study a modification of~     bilevel positive airway pressure therapy, BiPAP with Bi-Flex that may be more comfortable.~      Objectives: The primary objective of this study is to determine whether BiPAP with Bi-Flex~     results in improvement in adherence as compared to CPAP. The secondary objective is to~     determine whether Bi-Flex has similar therapeutic efficacy compared to CPAP, as determined by~     sleep study. Additional objectives include comparing CPAP and Bi-Flex effects on comfort and~     determining which parameters predict adherence.~      Study Design/Setting/Participants: A single center, randomized controlled double-blind study~     of Bi-Flex vs CPAP use in children with OSAS over a 3 month period.~      Intervention: Bi-Flex vs CPAP Study Measures: Objective compliance recordings, sleep study~     results, subjective questionnaire results. .~   "
236603|NCT00458393|"~     The purpose of this study is to determine whether daily use of emtricitabine/tenofovir~     disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV~     counseling, condoms, and treatment for other sexually transmitted infections (STIs).~   "
236604|NCT00458380|"~     On February 2004, a law (n. 40/2004) regulating assisted reproduction techniques (ARTs) was~     approved in Italy. This law aimed to regulate the treatment of infertility in Italy, contains~     several restrictions, such as the prohibition to fertilize more than three oocytes and the~     obligation to transfer simultaneously all embryos obtained. Several evidences showed that the~     outcome of the in-vitro fertilization (IVF) techniques is strongly correlated with quality of~     transferred embryos (choosing the right embryos). Furthermore, this prerequisite is actually~     illegal in Italy, and an optimal oocyte selection can be considered as the only one crucial~     factor in the determining the outcome of the IVF cycle (choosing the right oocytes).~     Experimental data have demonstrated that perifollicular blood flow assessment is a good~     marker of oocyte competence, embryo viability, implantation potential, and subsequent~     pregnancy rate.~      The purpose of this study will be to evaluate in a clinical setting whether the assessment of~     the perifollicular vascularity is a feasible and useful procedure for the selection of~     oocytes with the best developmental potential in IVF programs when only a limited number of~     oocytes can be fertilized.~   "
236605|NCT00458367|"~     The purpose of this research study is to gather information on the safety and efficacy of~     risperidone when used in routine clinical practice.~   "
236606|NCT00458354|"~     1. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural~          repair compared with standard of care methods (control) to obtain watertight dural~          closure intraoperatively in patients undergoing spinal surgery.~        2. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural~          repair compared with standard of care methods (control) to obtain watertight dural~          closure in patients undergoing spinal surgery up to 90 days post-procedure.~   "
236607|NCT00458341|"~     In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation~     (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator~     (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF~     due to a nonsense mutation. The main purpose of this study is to understand whether PTC124~     can safely increase functional CFTR protein in the cells of patients with CF due to a~     nonsense mutation.~   "
236608|NCT00458328|"~     Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group~     study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by~     ultrasound~   "
236609|NCT00458315|"~     The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel,~     Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.~   "
236610|NCT00458302|"~     The purpose of the study is to compare the efficacy, safety and tolerability of~     darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination~     therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who~     have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50~     copies/ml for at least 24 weeks.~   "
236611|NCT00458289|"~     Patients with end-stage renal disease (ESRD) commonly have high concentrations of~     phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability~     to excrete phosphorous by the kidneys. This in turn may result in the development of a~     condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease. As~     such, these patients often receive medications known as phosphate binders such as calcium~     carbonate or acetate, sevelamer, aluminum hydroxide and lanthanum carbonate to manage and~     treat hyperphosphatemia.~      Lanthanum carbonate is a newly available phosphate binding agent that is effective in the~     management of hyperphosphatemia and preventing secondary hyperparathyroidism. It works in the~     gastrointestinal tract by binding to the phosphorus in the diet. ESRD patients taking~     lanthanum carbonate are counseled to chew the tablets completely before swallowing, with or~     immediately after meals. However, patients who are intubated or receiving nutrition via~     feeding tubes are unable to chew the tablets. For these patients, medications are commonly~     crushed and administered via the tube. Moreover, some patients prefer to crush the tablets~     and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum~     carbonate tablets prior to administration and taking it with food would be as effective as~     chewing them.~      The purpose of this study is to compare the efficacy of phosphate binding between chewed and~     crushed lanthanum carbonate tablets.~   "
236612|NCT00458276|"~     Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability~     (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan~     is an investigational intravenous drug that blocks the endothelin receptors. This clinical~     trial will assess the potential benefit of tezosentan compared with placebo in the treatment~     of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time~     is from the start of surgery up to 24 hours.~   "
236613|NCT00458263|"~     One arm, open, prospective, intervention study to assess biochemical markers of growth~     response to Growth Hormone treatment in 20 Children, aged 3-9 years old, with idiopathic~     short stature. All participants will be treated with Growth Hormone during the first year of~     the study (and then in accordance with the local ethic requirement, to supply drug which is~     not approved for the indication used in the study, for additional 3 years) and then will be~     followed up for the next 3 years. The impact of Growth Hormone therapy on clinical laboratory~     parameters that are indicative of the growth response will be assessed by collecting blood~     and urine samples during the 4 years study period. The primary endpoints are measurements of~     height and growth velocity during the year of Growth Hormone treatment, the height at the~     beginning of puberty and final height. Secondary endpoints are psychological parameters,~     assessed by questionnaires.~   "
236614|NCT00458250|"~     Many patients suffering various malignant and non-malignant diseases need hematopoietic stem~     cell transplantation from a healthy person. In the majority of cases there is no matched~     related or unrelated donor.~      Some researchers have been performed transplantation from semi-matched (haploidentical)~     related donors with relatively good results.~      Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and~     their reports indicates good results.~      Chinese populations have more homogenous genetic background than Iranians. In this project,~     we are going to study the feasibility of this method of haploidentical transplantation in~     Iranian patients.~   "
236799|NCT00455832|"~     The aim of this study is to study the effect of peginterferon alpha and ribavirin on~     spermatozoa.~   "
236615|NCT00458237|"~     The purpose of this research study is to determine the safety of RAD001 and the highest dose~     of this drug that can be given to people with HER2-positive metastatic breast cancer safely~     in combination with trastuzumab. RAD001 has been used in patients with severe rheumatoid~     arthritis, in recipients of solid-organ transplants, healthy volunteers and experiments with~     animals, and information from those other research studies suggest that this RAD001 may help~     to stop cancer cells from growing abnormally.~   "
236616|NCT00458224|"~     In the county of Oppland, Norway, questionnaires addressing physical and mental health and~     socioeconomic status is issued to all (1960) families who meet for the pre-school assessment~     at the public health clinics in 2007. Particularly growth, physical activity and diet is~     addressed.~      Families who have children with a BMI >18.9, which corresponds to BMI>30, and living in~     selected municipalities in the county are invited to participate in a 5 year intervention~     program in order to avoid future overweight conditions in children. Similarly overweight~     children from the rest of the county serve as controls.~   "
236617|NCT00458211|"~     Because ziprasidone has not been extensively studied and is not widely accepted in the~     severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and~     relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who~     need a change of medication because of ineffectiveness or side effects will be changed to~     ziprasidone and followed with detailed assessments for eight weeks.~      The hypothesis is that they will improve and have fewer side effects.~   "
236618|NCT00458198|"~     This study will determine the effectiveness of integrated behavior therapy in treating~     children with selective mutism.~   "
236619|NCT00458185|"~     This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis~     (AS).~   "
236620|NCT00458172|"~     This study is the second empirical investigation in a series of studies, examining what~     everyday people believe that it means to be healthy. Part of this research also involves~     examining whether these lay theories of health vary according to various demographic~     classifications.~   "
236621|NCT00458159|"~     A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or~     Intermediate-1 Risk Myelodysplastic Syndromes.~   "
236622|NCT00458146|"~     The purpose of this study is to determine whether MM-093 is safe and effective in the~     treatment of RA.~   "
236623|NCT00458133|"~     The goal of the proposed study, Health Benefits of Aerobic and Resistance Training in~     individuals with type 2 diabetes (HART-D), is to compare the effect of resistance training~     alone (RT), resistance in combination with aerobic training (AT+RT), and aerobic training~     alone (AT) to standard care (SC) on hemoglobin A1C (HbA1C), in initially sedentary women and~     men with type 2 diabetes (T2D).~   "
236624|NCT00458120|"~     Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical~     regions of the world. There are four different forms (serotypes) of dengue virus that can~     cause dengue fever. The purpose of this study is to determine the safety and immune response~     to a vaccine containing a particular dengue serotype when an individual has been previously~     vaccinated with a different dengue serotype.~   "
236625|NCT00458107|"~     This study is being conducted to evaluate the safety and tolerability of ascending multiple~     oral doses of SCA-136 adminstered to healthy Japanese and non-Japanese female subjects.~   "
236626|NCT00458094|"~     This study will determine the effectiveness of a peer support system in increasing physical~     activity and effecting health behavior change in people with serious mental illnesses.~   "
236627|NCT00458081|"~     Primary objective:~        -  To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg~          versus a placebo during a 12 month period.~      Secondary objectives:~        -  Percentage of patients in both arms of the study whose levels of microalbuminuria~          decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months~          of treatment with rimonabant or placebo.~        -  To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month~          period on:~             -  Weight and waist circumference.~             -  Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c.~             -  Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C,~               apolipoproteins A1 and B.~             -  Inflammatory markers~             -  Adipocytokines.~             -  Blood pressure.~             -  Glomerular filtration rate.~        -  To assess the quality of life by means of questionnaire filled in.~        -  Safety parameters~   "
236628|NCT00458068|"~     Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at~     birth, the smaller the iron stores at birth and the higher the risk of iron deficiency.~      Hypothesis: Preterm infants with a birth weight of less than 1301g require iron~     supplementation earlier than previously recommended.~      Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron~     supplementation may reduce the incidence of iron deficiency and the need for late blood~     transfusions.~   "
236629|NCT00458055|"~     A low level of plasma high-density lipoprotein (HDL) cholesterol, the good cholesterol, is~     the most common lipid abnormality observed in patients with a premature atherosclerotic~     cardiovascular disease. HDL carry excess cholesterol from peripheral tissues to the liver to~     be metabolized or excreted, a process known as reverse cholesterol transport.~      Epidemiological studies have shown an inverse correlation between plasma levels of HDL~     cholesterol and the risk of cardiovascular disease. An increase in plasma HDL cholesterol~     levels by 1 mg/dL may reduce the risk of cardiovascular disease by 2 to 3%. The standard care~     of treatment for a low level of HDL cholesterol is: 1) lifestyle modifications including~     exercise, smoking cessation, weight control, moderate alcohol intake and decreased dietary~     fat intake - all patients are encouraged to follow these lifestyle modifications; 2)~     medications which can raise HDL cholesterol.~      Currently used medications to treat lipid disorders can increase, in some extent, HDL~     cholesterol. These include niacin (vitamin B3), fibric acid derivatives (fibrates) and~     statins. However there is no data on the effect of these medications on severe cases of HDL~     deficiency. This project aims to determine whether currently available medications, used in~     standard medical practice for the treatment of lipoprotein disorders, can substantially~     increase HDL cholesterol in severe cases of HDL deficiencies.~   "
236957|NCT00453739|"~     The objective of this observational study is to obtain long -term clinical and patient~     reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape)~     systems in women with stress urinary incontinence.~   "
236631|NCT00458029|"~     HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across~     the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at~     start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the~     schools were randomized to receive an intervention that integrated four components: the~     school nutrition environment, physical education class activities, behavior change~     initiatives, and educational and promotional communications activities.~   "
236632|NCT00458016|"~     The purpose of this study is to collect important information regarding the safety,~     tolerability, and efficacy of MB07803 when administered for 28 days in patients with type 2~     diabetes mellitus~   "
236633|NCT00458003|"~     Hypotension remains a common clinical problem after induction of spinal anesthesia for~     cesarean delivery. Maternal hypotension has been associated with considerable morbidity~     (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been~     the vasopressor of choice because of concerns about phenylephrine's potential adverse effect~     on uterine blood flow. This practice was based on animal studies which showed that ephedrine~     maintained cardiac output and uterine blood flow, while direct acting vasoconstrictors, e.g.,~     phenylephrine, decreased uteroplacental perfusion. However, several recent studies have~     demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating~     hypotension and may be associated with a lower incidence of fetal acidosis. All of these~     studies have been performed in healthy patients undergoing elective cesarean delivery.~      Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal~     and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of~     the infant. These patients often have uteroplacental insufficiency. Given the potential for~     significant hypotension after spinal anesthesia and its effect on an already compromised~     fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal~     anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as~     compared to epidural anesthesia when hypotension is treated adequately. Due to problems~     related to management of the difficult airway and coagulopathy, both of which are more common~     in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique.~     Recent studies have demonstrated that preeclamptic patients may experience less hypotension~     after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for~     the treatment of spinal anesthesia-induced hypotension has not been studied in women with~     preeclampsia. The aim of our study is to compare intravenous infusion regimens of~     phenylephrine versus ephedrine for the treatment of spinal anesthesia induced hypotension in~     preeclamptic patients undergoing cesarean delivery. The primary outcome variable is umbilical~     artery pH.~   "
236634|NCT00457990|"~     Background: Iron deficiency in early childhood may impair neurodevelopment.~      Aim: To examine whether early iron supplementation improved neurodevelopment in preterm~     infants.~      Method: Children who participated in a clinical trial of iron supplementation were invited~     for a neurodevelopmental follow-up examination at the time of school entry.~   "
236635|NCT00457977|"~     Pneumococcal disease is a serious bacterial infection that can affect different parts of the~     body, including the lungs. People with chronic illnesses, such as chronic obstructive~     pulmonary disease (COPD), have a greater risk of developing pneumonia and meningitis as a~     result of pneumococcal disease. This study will compare the immune response to two types of~     pneumococcal vaccines in adults with COPD.~   "
236636|NCT00457964|"~     The purpose of this research study is to find out what effects RAD001 has on angiomyolipomas~     of a person with Tuberous Sclerosis Complex and to determine the safe dose of RAD001 without~     toxicity.~      The hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly~     even cause regression.~   "
236637|NCT00457951|"~     The purpose of this study is to determine whether ODSH, when added to conventional treatment,~     is more effective in treating COPD exacerbations than conventional therapy alone.~   "
236638|NCT00457938|"~     Lipodystrophies represent a therapeutic challenge with regards to the management of the~     diabetes, insulin resistance, hypertriglyceridemia and fatty liver which frequently present~     in conjunction with significant adipose tissue loss. The purpose of the study and it's four~     subprojects is to examine the safety and efficacy of various novel interventions designed to~     improve or resolve the fatty liver, hypertriglyceridemia, and insulin resistance or diabetes~     that is seen in these patients.~   "
236639|NCT00457925|"~     This is a phase one study investigating the absorption, distribution, metabolism and~     excretion of GSK221149A in six healthy women of non-child bearing potential.~   "
236640|NCT00457912|"~     The objective of this study is to identify and maintain a registry of well-characterized~     limb-girdle muscular dystrophy (LGMD) patients. Patients seen as part of this study may be~     candidates for future treatment trials based on their defined genetic classification of LGMD.~     In the course of this study, the investigators will perform a muscle biopsy and DNA testing~     in an unlimited number of patients with clinically diagnosed LGMD. The genetic testing will~     be extended to the family of the study subject in order to better understand true genetic~     defect.~   "
236641|NCT00457899|"~     The purpose of this study is to determine whether increasing the amount (dose) of quetiapine~     IR (immediate release formulation) more rapidly than conventional dose increases, improves~     the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a~     psychiatric assessment scale that measures both positive and negative symptoms - in patients~     with acute schizophrenia or schizoaffective disorder.~   "
236642|NCT00457886|"~     The purpose of this study is to measure hormones in the blood known to affect the timing of~     delivery after a single injection of 17-P in order to help understand its mechanism of action~     in preventing preterm delivery.~   "
236643|NCT00457873|"~     Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have~     serious complications. It has recently been suggested that isotonic saline may be a more~     appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare~     isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support~     in order to:~      Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial~     comparing these solutions.~      Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of~     hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous~     fluids at at least 50% of the traditional maintenance rate for an interval of at least 8~     hours.~      Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.~   "
236644|NCT00457860|"~     RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal~     cells. This may be an effective treatment for chronic lymphocytic leukemia (CLL),~     prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL that has not responded to~     chemotherapy, surgery or radiation therapy.~      PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015~     immunotoxin in treating patients who have chronic lymphocytic leukemia, prolymphocytic~     leukemia or small lymphocytic lymphoma that has not responded to treatment~   "
236645|NCT00457847|"~     Primary graft dysfunction (PGD) is a severe lung injury that can occur in the days following~     lung transplant surgery. The purpose of this study is to identify genetic factors that may~     put someone at risk for developing PGD.~   "
236646|NCT00457834|"~     Cardiac resynchronization therapy (CRT) is used to treat dilated heart failure with~     discoordinate contraction. Dyssynchrony typically stems from electrical delay leading to~     mechanical delay between the septal and lateral walls. Right ventricular apical pacing might~     be associated with long-term adverse effects on left ventricular function, and alternative~     pacing sites such as high septal or RVOT has been suggested. Previous studies have however~     been conflicting. The aim of this study is to determine if bi-ventricular pacing from RVOT +~     LV is better than RVapex+LV. To avoid influence from possible atrial delay only patients with~     chronic atrial fibrillation are included. All patients will receive a bi-ventricular~     pacemaker with 3 leads placed in RVapex, RVOT and via coronary sinus to pace the left~     ventricle. After a run in period (to determine if AV-junction ablation is necessary) the~     patients are randomised to one of the following pacing configurations: RVOT+LV or RVapex+LV~     with cross-over after 3 month.~   "
236647|NCT00457821|"~     The purpose of this study was to evaluate the safety and tolerability of ivacaftor in~     patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation~     in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent~     and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR~     protein. Potentiators are pharmacological agents that increase the chloride ion transport~     properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA)~     activation.~   "
236648|NCT00457808|"~     The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in~     patients with tuberous sclerosis complex or lam.~   "
236649|NCT00457795|"~     This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in~     patients with glaucoma or ocular hypertension~   "
236650|NCT00457782|"~     The aim of this study is to determine the safety, tolerability and dose-limiting toxicities~     of KW-2478 and to determine the Maximum Tolerated Dose and recommended Phase II dose for~     patients with relapsed/refractory MM, CLL or B-cell NHL.~   "
236651|NCT00457769|"~     Medications for memory improvement are available but they may not actually improve the~     ability to do real world tasks. The purpose of this research study is to determine if a~     medicine used to treat memory problems donepezil(Aricept) enhances the ability to remember~     steps of functional tasks and the actual ability to perform tasks relevant to real-life~     independence. Aricept is an FDA approved medication for the treatment of Alzheimer's disease.~     Aricept is an investigational drug for the purposes of this study, and is not approved for~     this purpose.~   "
236652|NCT00457756|"~     This is a double-blind, placebo-controlled study to assess the effectiveness of BiosLife in~     lowering serum LDL cholesterol and raising HDL cholesterol. BiosLife is a natural supplement~     (mixed in water and taken twice daily) which contains guar gum and other natural soluble~     fibers, phytosterols, policosanol, and a proprietary chrysanthemum extract. Approximately 100~     subjects with baseline LDL cholesterol of 110-190 mg/dL will be randomized in a 2:1 ratio to~     BiosLife or a look-alike placebo. Changes in lipids from baseline will be assessed at 6 weeks~     and 12 weeks.~   "
236653|NCT00457743|"~     Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248)~     following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by~     reviewing the safety and tolerability.~      Phase II;To determine the objective tumor response and the safety of Sunitinib malate~     (SU011248) at the clinically recommended dose.~   "
236654|NCT00457730|"~     Many patients with Multiple Sclerosis experience pain that is caused by the effects of MS on~     the nervous system.~      The purpose of this study is to see if an investigational drug (Duloxetine) will reduce pain~     in subjects with MS.~      The US Food and Drug administration (FDA) has approved this drug for use with depression or~     pain from diabetes.However, it is considered investigational for this study because it has~     not been approved for patients with MS.~      This study will recruit patients with MS who have central pain which is 4 or greater on a~     scale of 1-10. Patients must have experienced pain for 2 months or longer prior to begining~     the study.The study will last 10 weeks, patients will be randomized either Duloxetine or~     placebo and will be carefully monitored throughout the study. Patients will keep pain/sleep~     diaries during the study period and will be provided Ibuprofen for pain control.~   "
236655|NCT00457717|"~     This study was designed to compare the difference of using atropine eyedrops alone from~     atropine combined with the stimulation of auricular acupoints therapy in reducing myopia~     progression.~   "
236656|NCT00457704|"~     Methicillin resistant Staphylococcus aureus (MRSA) which is one of the principal multidrug~     resistant organisms found in the hospitals all over the world, has recently emerged in the~     community. However, for the moment (2002), the hospital remains the principal reservoir of~     MRSA so far and the patients discharged with a MRSA carriage can be the source of MRSA~     spreading in the community. In particular patients admitted to home care (HC) from acute care~     facilities represent a patient group with a high risk of MRSA carriage and of being the~     source of MRSA spreading in the community. The objective of this study is to determine~     whether HC patients are effectively a MRSA reservoir and a source for MRSA spreading in the~     community.~      For that, from February 2003 to March 2004 any adult patient (except obstetric patient)~     (approximately 3360 patients for 16 HC settings), will be screened [nasal and skin lesion (if~     any) swabs] for MRSA carriage within the 48 h before his/her transfer. The patients found to~     be MRSA carriers will be visited by a physician who will ask patients as well as family~     members to participate in the study. Each patient and each family member who will have given~     agreement to participate, will be sampled (nasal swab for both patient and family members,~     and skin lesion swab for the patients with skin lesions) every month for 12 months by the~     nurse of the HC setting in which the patient will have been admitted. As soon as the patient~     will be discharged from HC setting and if the 12 month survey is not finished, patient and~     family member swab sampling will be performed by the nurse of the research team (NRT) every 3~     months until the end of the survey period. These swabs will be transmitted by the NRT to the~     research center and analyze by the microbial technician of the research center. The~     bacteriological survey will be accompanied with an epidemiological survey in order to~     determine the risk factors for a long term MRSA carriage in the patients admitted in HC and~     also the risk factors for transmitting MRSA to their family.~      This multi-centre and multi-investigator study will be performed over a period of 32 months~     (1 month to prepare the study, 13 months to screen patients with regard to MRSA carriage~     before their transfer from acute care settings into HC settings, 12 months to survey HC~     patients and their family members and 6 months to analyze data and prepare publications).~     Such a study will provide us with descriptive and quantitative data on MRSA strains~     introduced in the community by HC patients. From the analysis of risk factors of MRSA~     transmission from these patients to their family members, suggestions to limit this~     transmission might be drawn.~   "
236657|NCT00457691|"~     The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan,~     Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI~     chemotherapy without adding sunitinib as the first line treatment of patients with metastatic~     colorectal cancer.~   "
236658|NCT00457678|"~     The purpose of this study is to demonstrate that Visudyne-Lucentis-dexamethasone (V-L-D)~     triple therapy will give similar efficacy and safety results as Lucentis monotherapy.~   "
236958|NCT00453726|"~     The purpose of the study is to evaluate variation of BNP in non invasive mechanical~     ventilated patients with severe acute respiratory failure.~   "
236659|NCT00457665|"~     The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not~     known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and~     reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.~      The project therefore has the following aims: 1) to characterize metabolic abnormalities and~     changes in body fat distribution, 2) to develop objective criteria for defining the syndrome~     and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the~     lipodystrophy syndrome in HIV-infected patients.~   "
236660|NCT00457652|"~     Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?~   "
236661|NCT00457639|"~     To evaluate the efficacy and safety of cholic acid therapy in treating lipodystrophy patients~     with hepatic steatosis. This is a randomized, double-blind, placebo-controlled cross-over~     study.~   "
236662|NCT00457626|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term~     use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.~   "
236663|NCT00457613|"~     Septic shock is the most common cause of death in patients requiring intensive care. The~     kidney is one of the first organs to fail, stressing the importance to search for clinical~     interventions that may protect the kidneys during sepsis.~      Alkaline phosphatase functions as a host defence molecule and is present in many cells and~     organs (e.g. intestine, placenta, liver, kidney and bone). Alkaline phosphatase has a dual~     mode of action. First, it binds to and, subsequently, dephosphorylates lipopolysaccharide~     (LPS). Second, the enzymatic reaction product monophosphoryl-LPS is a non-toxic substance for~     mammals which acts as a partial antagonist on the LPS receptor complex. In several animal~     studies, administration of alkaline phosphatase attenuates the inflammatory response and~     reduces mortality.~      It is unknown whether these results can be extrapolated to septic patients . We studied the~     effects of alkaline phosphatse administration on kidney damage and function in patients with~     severe sepsis or septic shock.~   "
236664|NCT00457600|"~     The emergency department (ED) constitutes a high-risk environment for errors and poor quality~     of care. Pediatric patients are at increased risk of medical errors. We postulate that~     implementation of a patient-centered health information technology - ParentLink - can address~     system-level deficiencies and the unique “just-in-time” information needs of ED physicians~     and the parents of ill children. The proposed work delivers an innovative product – an~     electronic interface linked to a pediatric knowledge base that integrates parent-derived data~     with best practices for safe and effective emergency care across common pediatric disease~     conditions: otitis media, urinary tract infections, asthma, and head trauma. The study has~     two aims, the first of which addresses critical gaps in data capture: to evaluate the~     completeness and accuracy of information on symptoms, disease condition, medications and~     allergies generated by parents using ParentLink versus information documented by ED~     physicians and nurses, using structured telephone interviews as a gold standard. The second~     aim measures the ParentLink’s impact on ED patient safety and quality, specifically: a) the~     error rate for ordering and prescribing of medications during ED care, and b) the percent of~     ED visits that adhere to national evidence-based guidelines. Parentlink will be rigorously~     evaluated in a clinical trial at two diverse ED sites and will use a sequential,~     non-randomized observational design with two intervention and two control periods to measure~     the effects of ParentLink on data capture and safety and quality of patient care.~   "
236665|NCT00457587|"~     Adrenocortical carcinoma (ACC) is a rare and heterogeneous malignancy with poor prognosis.~     Surgical resection of the tumor is the treatment of choice. However, even after complete~     resection more than 80 % of patients will experience recurrence of disease. Therefore, new~     treatment options are urgently needed. This pre-clinical study try to lay the foundations for~     a successful immunotherapy in patients with ACC.~   "
236666|NCT00457574|"~     GMX1777 is a water-soluble, intravenously-administered prodrug of GMX1778. GMX1777 is rapidly~     converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of~     cell lines and models from different tumor origins.~   "
236667|NCT00457561|"~     Decreased body fat mass, possibly mediated through the effects of elevated serum adiponectin~     levels, may be associated with requirements for higher recombinant human erythropoietin doses~     and a subsequent worse prognosis in patients beginning hemodialysis.~   "
236668|NCT00457548|"~     The purpose of this study is to determine if a brief counseling intervention, delivered by~     telephone, is more effective than standard ED care, to reduce future alcohol related injuries~     and alcohol related negative consequences, among patients treated in the ED for injuries from~     an MVC and other injury mechanisms.~   "
236669|NCT00457535|"~     Responsiveness of recombinant human erythropoietin (rHuEPO) is known to be related with body~     fatness in hemodialysis (HD) patients. Adiponectin (ADPN) is inversely associated with body~     fat mass, and in healthy subjects, low ADPN is a predictor of mortality. Recently, higher~     rHuEPO dose itself is demonstrated to be associated with poor prognosis. So, in this study,~     we prospectively examined the relationship between rHuEPO dose, serum ADPN, and mortality in~     patients beginning HD.~   "
236670|NCT00457522|"~     Although abuse by an intimate partner is very common and has serious negative effects on~     women's health, few studies have been done to test ways to increase safety for women in~     abusive relationships. This study will test a telephone intervention for women who report~     physical, emotional, and/or sexual abuse within the past 12 months, to see if~        -  women use more safety behaviors and access more community resources~        -  chronic pain, fatigue, depressive, and post-traumatic stress disorder (PTSD) symptoms~          affect a women's ability to use safety behaviors and access community resources.~   "
236671|NCT00457509|"~     The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose~     schedule in immunologically naïve adults against one vaccine formulation without adjuvant in~     terms of tolerance and immunogenicity~      Primary Objective:~      To describe the safety profile and immunogenicity following each injection.~   "
236672|NCT00457496|"~     The primary purpose of this study is to evaluate the effectiveness of a workplace cognitive~     and physical program (Intervention), in reducing the frequency of head and neck pain~   "
236959|NCT00453713|"~     The purpose of this study is to identify factors that contribute to higher mortality rates~     among blacks and Hispanics with diffuse parenchymal lung disease.~   "
236673|NCT00457483|"~     High blood pressure is an important risk factor for diseases of heart and blood vessels like~     myocardial infarction and stroke. Many patients are not treated to target blood pressures,~     even though good blood pressure lowering drugs are available. Not all blood pressure drugs~     are equally effective in individual patients.~      We hypothesize that individual patient characteristics can predict the best response on~     different blood pressure lowering drugs. In this study we will investigate whether a set of~     patient characteristics (anthropometric and laboratory) obtained before treatment may predict~     the blood pressure lowering response to representatives of two groups of drugs: those that~     inhibit renin-angiotensin system activity and those that decrease blood volume.~   "
236674|NCT00457470|"~     This study will evaluate the safety and efficacy of AG-014699 in diabetic patients~   "
236675|NCT00457457|"~     This is a 12 week study in which different doses and formulations of UK-369,003 will be~     administered to patients with a diagnosis of enlarged prostate. Patients will complete a~     series of questionnaires before, during and after treatment to assess if UK-369,003 has~     improved their urinary symptoms and erectile function . There will be several blood samples~     taken during the study to asses the level of drug in the blood and correlate it with the~     responses to the questionnaires.~   "
236676|NCT00457444|"~     Primary Objective Comparison of the inhibition of the allergic response assessed by nasal~     provocation test after epicutanous pollen allergen administration and placebo epicutaneous~     administration.~      Secondary Objectives Comparison of the efficacy of the placebo with that of the epicutanous~     pollen allergen administration evaluated by visual analog symptom scales (nasal itching,~     sneezing, rhinorrhea, conjunctival redness, and lacrimation, lung symptoms ), Comparison of~     the inhibition of the allergic response assessed by skin prick test after epicutanous pollen~     allergen administration and placebo epicutaneous administration.~        -  Trial with medicinal product~   "
236677|NCT00457431|"~     ILCOR Recommendations On the basis of the published evidence to date, the Advanced Life~     Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made~     the following recommendations in October 2002: Unconscious adult patients with spontaneous~     circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to~     24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be~     beneficial for other rhythms or in-hospital cardiac arrest (Circulation. 2003;108:118-121).~     This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and~     neurological outcome in patients after in-hospital cardiac arrest.~   "
236678|NCT00457418|"~     The purpose of this study is to establish the pharmacokinetics of PEG-Intron, administered at~     a dose of 6 μg/kg/week for 8 weeks (induction treatment), followed by a dose of 3 μg/kg/week~     for up to 252 weeks (maintenance treatment), in patients with high risk melanoma.~   "
236679|NCT00457405|"~     This study is performed to determine whether a seven day treatment with dipyridamole (slow~     release, 200mg twice daily) can induce a protective effect against ischemia-reperfusion~     injury, after ischemic exercise of the non-dominant forearm in healthy volunteers.~   "
236680|NCT00457392|"~     This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib~     alone in patients with advanced/metastatic lung cancer who have received previous treatment~     with a platinum-based regimen.~   "
236681|NCT00457379|"~     Patients with coronary artery disease are characterized by an increased cardiovascular risk~     and they often have low blood high density lipoprotein (HDL)-cholesterol levels or~     HDL-cholesterol with modified vasculoprotective properties.~      The purpose of the present study is to characterize the quality of HDL-cholesterol in~     patients with coronary artery disease and normal blood HDL-cholesterol levels and to examine~     the effect of exercise training on the vasculoprotective effects of HDL-cholesterol in these~     patients. Additionally, the researchers aim to investigate the endothelial function,~     oxidative stress and the regenerative capacity of the endothelial progenitor cells in~     patients with coronary artery disease and the changes dependent on physical activity of~     patients.~   "
236682|NCT00457366|"~     In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M.~     Haloperidol cocktail (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to~     be an effective treatment. However, since it is an intramuscular injection, it is more~     complicated and perhaps less acceptable to patients as well as more likely to cause EPS~     (extrapyramidal symptoms). Of late in our emergency room, we started using high dose~     Quetiapine 300 mg PO to replace the cocktail for treating agitation. It has shown promising~     results.~      This study is designed to compare the efficacy and safety of Quetiapine with the routine~     cocktail for treatment of agitation.~      The primary purpose of this study is to determine the efficacy and safety of Quetiapine by~     using high dose Quetiapine (300 mg) PO to treat agitated patients in the psychiatric~     emergency room.~      The secondary purpose is to test the immediate effect on agitation caused by illicit drug~     abuse or the alcohol abuse.~   "
236683|NCT00457353|"~     Primary:~        -  To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea~          in children~      Secondary:~        -  To evaluate the safety of Enterogermina® in acute diarrhea in Indian children~   "
236684|NCT00457340|"~     To assess in patients with CAD [coronary artery disease] and an implantable defibrillator the~     effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular~     arrhythmia (ventricular tachycardia or ventricular fibrillation requiring ICD [implantable~     cardioverter defibrillator] intervention) within one year after randomization.~   "
236685|NCT00457327|"~     The purpose of this study is to determine whether protective ileostomy is required after low~     anterior resection due to rectal cancer~   "
236686|NCT00457314|"~     Mitochondrial myopathies include various inherited diseases that are caused by damage to the~     mitochondria, energy-producing structures that fuel the body's processes. The main symptoms~     are muscle weakness, reduced muscle mass, and difficulty with exercising. The purpose of this~     study is to determine the effects of exercise training versus inactivity on mitochondrial~     function in muscle and muscle performance in people with mitochondrial myopathies.~   "
236701|NCT00457119|"~     This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients~     with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD~     001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in~     combination with carboplatin, paclitaxel and bevacizumab~   "
236687|NCT00457301|"~     The objective of this study is to assess the effects of using HRQL measures in the clinical~     care of pre- and post-lung transplant patients.~      The hypotheses are that the inclusion of HRQL measures, the Health Utilities Index System~     Mark 2(HUI2) and Mark 3 (HUI3), in routine clinical care of pre- and post-lung transplant~     patients, will: 1) improve patient-clinician communication;2) affect patient management; 3)~     improve patients' HRQL.~   "
236688|NCT00457288|"~     The current study will investigate the effects of TF002 on cutaneous mastocytosis or~     cutaneous involvement of systemic mastocytosis as compared to clobetasol proprionate~     (positive control) and a general skin care product without active ingredient targeting~     mastocytosis (negative control) based on clinical effects on Darier´s signs and the~     histological evaluation of mast cell numbers in skin bioptic material.~   "
236689|NCT00457275|"~     To evaluate the LDL-C lowering in south african patients with primary hypercholesterolaemia~     after the addition of ezetimibe 10mg /day to ongoing therapy with a statin.~   "
236690|NCT00457262|"~     paraoxonase 1 is involved to prevent LDL and HDL oxidation,so increase of it's activity leads~     to lower risk of coronary heart disease.In postmenopausal women ,we have decrease of~     paraoxonase1 activity and soy proteins may increase paraoxonase1 activity~   "
236691|NCT00457249|"~     It is well recognized that older adults can contract pertussis, suffer its complications, and~     unwittingly transmit it to close contacts, which may well include infants too young to have~     received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in~     the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for~     administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no~     upper limit on its age indication.~      The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine~     among individuals ≥ 65 years of age.~   "
236692|NCT00457236|"~     This study is a prospective, single-center evaluation of the impact of the variability in~     platelet response after loading with clopidogrel on the peri-interventional risk of patients~     undergoing PCI.~   "
236693|NCT00457223|"~     The purpose of this study is to compared between conventional pterygium excision and AMT~     transplantation with suture and with fibrin glue.~   "
236694|NCT00457210|"~     The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain~     will be assessed at 3 time points before and after the treatment.~   "
236695|NCT00457197|"~     The purpose of this study is to find out whether an investigational drug called quetiapine~     can treat bipolar disorder, improve mood and reduce alcohol use and craving.~   "
236696|NCT00457184|"~     Migraine was described as related to stroke in adults and children as well. Complete~     thrombophilic status was not study in large groups of pediatric patients. The purpose of our~     study is to assess the prethrombotic profile among children and teenagers diagnosed as~     suffering from migraine attacks.~   "
236697|NCT00457171|"~     The aim of this double blind, placebo controlled, study is to evaluate activity consistent~     with efficacy provided by 14 days administration of GI270384X, and to provide preliminary~     pharmacokinetics and safety/tolerability of 14 days administration of GI270384X in patients~     with mild to moderate active ulcerative colitis (UC).~   "
236698|NCT00457158|"~     The purpose of this study is to assess efficacy and safety of optional vena cava filter~     implanted 3 months in prevention of recurrent pulmonary embolism in patients presenting with~     acute pulmonary embolism associated with thrombotic risk factors~   "
236699|NCT00457145|"~     This study will examine whether the drug ranibizumab is an effective treatment for macular~     telangiectasia, a condition in which existing blood vessels near the macula (the back part of~     the eye responsible for sharp central vision) become dilated and twisted, and new abnormal~     blood vessels may form under the retina. Both the existing dilated vessels, as well the new~     subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This~     study will see if ranibizumab can slow or stop the leakage and growth of existing, dilated,~     macular vessels in cases where new vessel formation under the retina is absent.~      Patients 18 years of age and older who have macular telangiectasia without new blood vessel~     formation may be eligible for this study. Visual acuity must be 20/40 or worse.~      Participants receive at least four injections of ranibizumab into the eye over a 12-week~     period. After the fourth injection, additional injections may be given every 4 weeks for up~     to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab~     treatment, patients undergo the following procedures:~        -  Medical history and physical examination.~        -  Eye examination, including dilation of the pupils and measurement of the fluid pressure~          in the eye.~        -  Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the~          blood vessels in the eyes. Photographs of the retina are taken with a special camera~          that flashes a blue light into the eye. The photos show whether any dye has leaked from~          the vessels into the retina.~        -  Indocyanine green angiography: This procedure identifies feeder vessels that may be~          supplying the abnormal blood vessels. The test is similar to fluorescein angiography,~          but uses a green dye and flashes an invisible light.~        -  Autofluorescence imaging: This test examines how well the retina functions. The back of~          the eye is photographed with a bright light.~        -  Optical coherence tomography: This test measures retinal thickness. A light shined into~          the eye produces cross-sectional pictures of the retina. The measurements are repeated~          during the study to determine if retinal thickening is getting better or worse, or~          staying the same.~        -  Stereoscopic color fundus photography: The pupils are dilated and special photographs of~          the inside of the eye are taken to evaluate the retina and measure changes that occur~          over time. The camera flashes a bright light into the eye for each picture.~        -  Follow-up visits: The doctor evaluates the effects of the study treatment before and~          after each injection. Patients are contacted by phone 3 days after each injection to~          check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after~          the last treatment.~   "
236700|NCT00457132|"~     Context: The many treatments and devices developed to unload the diseased articular surface~     in knee osteoarthritis have provided limited solutions. A novel biomechanical device~     comprising of four individually calibrated elements attached onto foot-worn platforms was~     recently developed. This device is capable of such unloading during standing and walking,~     simultaneously strengthening dynamic stabilizers and training neuromuscular control by~     controlled biomechanical perturbations.~      Objective: To asses the effectiveness of this device in reducing pain and improving function~     in patients with knee osteoarthritis.~      Design and Setting: Randomized, controlled and double blind prospective trial, conducted from~     September 2005 to February 2006, in the Department of Orthopedics, Asaf Harofeh Medical~     Center (Zerifin, Israel).~      Patients: Sixty-one patients with diagnosed knee osteoarthritis who self-reported~     moderate-to-severe level pain.~      Interventions: Patients were randomly assigned into active and control groups and underwent 8~     weeks of treatment. The active group was treated with the device and its four biomechanical~     elements that had been individually calibrated to accommodate a pain-free joint alignment.~     The control group was treated with the device’s platforms without the biomechanical elements.~      Primary Outcome Measures: The patients were evaluated three times during the study: at~     baseline, after 4 weeks and at the 8 week endpoint. Primary outcomes were the Western Ontario~     and McMaster Osteoarthritis Index (WOMAC) and the Aggregated Locomotor Function (ALF)~     assessment.~   "
236702|NCT00457106|"~     This study compares the efficacy of risperidone to that of paroxetine in the treatment of~     panic attacks in patients with Panic Disorder and with Major Depressive Disorder with Panic~     attacks and compares the side effect profile of risperidone vs. paroxetine in treatment of~     panic attacks and compares response rates of risperidone vs. paroxetine in treatment of panic~     attacks.~   "
236703|NCT00457093|"~     The purpose of this study that when studies using our method of dosing adjustments driven by~     continuous glucose monitoring and because of the less variable glycemic effect of insulin~     detemir, insulin detemir treated subjects will spend a significantly greater time in the~     glucose target range than insulin glargine.~   "
236704|NCT00457080|"~     The aim of this study is to increase the detection of undiagnosed obstructive sleep apnea~     (OSA) and secondly to increase the sensitivity for detection of respiratory depression (< 6~     breaths per minute) in post operative patients on the general care nursing unit.~   "
236705|NCT00457067|"~     This study will examine whether the drug ranibizumab is an effective treatment for macular~     telangiectasia, a condition in which existing blood vessels near the macula (the back part of~     the eye responsible for sharp central vision) become dilated and twisted, and new abnormal~     blood vessels may form under the retina. Both the existing dilated vessels, as well the new~     subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This~     study will see if ranibizumab can slow or stop the leakage and growth of new vessels forming~     under the retina.~      Patients 18 years of age and older who have macular telangiectasia in both eyes and new blood~     vessel formation under the retina in at least one eye may be eligible for this study. Visual~     acuity must be 20/40 or worse.~      Participants receive at least four injections of ranibizumab into the eye over a 12-week~     period. After the fourth injection, additional injections may be given every 4 weeks for up~     to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab~     treatment, patients undergo the following procedures:~        -  Medical history and physical examination.~        -  Eye examination, including dilation of the pupils and measurement of the fluid pressure~          in the eye.~        -  Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the~          blood vessels in the eyes. Photographs of the retina are taken with a special camera~          that flashes a blue light into the eye. The photos show whether any dye has leaked from~          the vessels into the retina.~        -  Indocyanine green angiography: This procedure identifies feeder vessels that may be~          supplying the abnormal blood vessels. The test is similar to fluorescein angiography,~          but uses a green dye and flashes an invisible light.~        -  Autofluorescence imaging: This test examines how well the retina functions. The back of~          the eye is photographed with a bright light.~        -  Optical coherence tomography: This test measures retinal thickness. A light shined into~          the eye produces cross-sectional pictures of the retina. The measurements are repeated~          during the study to determine if retinal thickening is getting better or worse, or~          staying the same.~        -  Stereoscopic color fundus photography: The pupils are dilated and special photographs of~          the inside of the eye are taken to evaluate the retina and measure changes that occur~          over time. The camera flashes a bright light into the eye for each picture.~        -  Follow-up visits: The doctor evaluates the effects of the study treatment before and~          after each injection. Patients are contacted by phone 3 days after each injection to~          check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after~          the last treatment.~   "
236706|NCT00457054|"~     The purpose of this study is to find out what parts of the brain have increased or decreased~     activity with individuals who have bipolar disorder and how medicine changes this activity in~     bipolar subjects. Another purpose of this study is to compare data obtained from bipolar~     depressed subjects with data obtained from healthy subjects. In this study we will measure~     activity in different parts of the brain, while participants see pictures, using Magnetic~     Resonance Imaging (MRI) scan. We will do two MRI scans with each subject before and after~     treatment for eight weeks with a standard bipolar disorder medication called lithium.~   "
236707|NCT00457041|"~     This pilot study will explore the usefulness of a series of questions asking about views of~     research from the perspective of minority and economically disadvantaged research~     participants. Racial and ethnic minorities are consistently under-represented in clinical~     research. This under-representation has been attributed primarily to an unwillingness to~     participate in research because of mistrust in the research establishment, especially in~     light of widely known historical examples of abuse. However, more recent data suggests that~     not being invited to participate in research, or stringent entry criteria, may contribute~     substantially to the low numbers of ethnic minority research participants. The perspectives~     of racial and ethnic minorities who are knowledgeable about or participating in research are~     important to understanding the kinds of vulnerabilities that exist and any important barriers~     to participation.~      People 18 years of age and older from the Cardozo clinic in Washington, D.C., who are~     enrolled in the National Institute of Arthritis and Metabolic Studies' natural history study~     are eligible to participate in this protocol.~      Participants are interviewed with questions about their own experiences in clinical research~     as well as some hypothetical research studies. Questions include participants' general views~     of clinical research, perceived risks and benefits of research, alternatives to research~     participation, the limits of what they would be willing to accept in research and types of~     research or research procedures they might perceive as unfair.~   "
236708|NCT00457028|"~     The purpose of these questionnaires is to give us an overview of how OCD has affected your~     life and perhaps also to give us some clues about things that may have set you up to~     experience OCD.~   "
236709|NCT00457015|"~     The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide)~     versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.~   "
236710|NCT00457002|"~     The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep~     vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within~     patients hospitalized for acute medical illness, and to learn how apixaban compares to~     enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be~     studied.~   "
236711|NCT00456989|"~     This clinical research study is being done because there is no effective treatment for~     advanced androgen-independent prostate cancer. This study will determine if the combination~     of medications (Taxotere and Doxil) are effective in this kind of cancer.~   "
236712|NCT00456976|"~     Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however~     their efficacy in treating negative symptoms is limited. This study wants to evaluate~     efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in~     inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients~     will select to receive selegiline or placebo.~      Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1-~     Patients with moderate to severe negative symptoms 2- Patients with at least one year~     antipsychotic drug therapy, at the current dose >= 1 month. 3- No other psychotropic drugs~     during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse,~     severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during~     past month.~   "
236723|NCT00456833|"~     This study aims to assess the value of combined treatment with RAD001 and erlotinib in~     patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic~     therapy.~   "
236713|NCT00456963|"~     Background. Antihypertensive therapy with ß-blockers (ßBs) and diureticts (Ds) is accompanied~     by a higher incidence of diabetes mellitus (DM) than therapy with ACE-inhibitors (ACEIs) or~     angiotensin-receptor blockers (ARBs). Whether this difference is due to an antidiabetogenic~     action of ACEIs and ARBs or to the fact that these agents are free of the diabetogenic~     activity of ßBs and Ds is unknown. Prevention of DM as well as of HT is of primary health~     concern.~      Objectives. The primary objective of PHIDIAS is to test whether in individuals with~     components of metabolic syndrome making them predisposed to DM and HT, addition of either an~     ACEI or an ARB to periodically reinforced lifestyle counselling can reduce 1) onset of DM and~     2) onset of HT significantly more than lifestyle plus placebo. Secondary objectives are 1)~     comparing the antidiabetogenic effects of ACEI and ARB, and 2) investigating whether the~     effects of ACEI and ARB on DM and HT persist at least 6 months after treatment withdrawal.~      Methods. PHIDIAS is a prospective, double-blind, placebo-controlled 3-arm comparison trial.~     300 general practitioners (members of SIMG with the assistance of hospital centres of SIIA)~     will randomise 6000 untreated individuals aged 40-75 years, with SBP 130-139 or DBP 85-89~     mmHg, fasting glucose (FG) 100-125 mg/dl, waist circumference >= 102 (M) or >= 88 cm (W), to~     three blinded treatments, given in addition to lifestyle advise: 1) Placebo; 2) the ACE~     Enalapril (10 mg, then 20 mg od); 3) the ARB Losartan (50 mg, then 100 mg od).Double-blind~     treatment will be maintained until 500 cases of DM are observed (presumably average of 36~     months) (Treatment Phase: control visits, BP, FG every 6 months). This will be followed by a~     6-month Withdrawal Phase (active treatment substituted by placebo). Primary outcomes are DM~     (FG >= 126 mg/dl) and HT (SBP >= 140 or DBP >= 90 mmHg) on 2 consecutive visits. PHIDIAS will~     be governed by a Steering Committee assisted by a blinded Event Adjudicating Committee and an~     independent DMSB.~      Expected results. The sample size is adequate (alfa 5%, power 90%) to evaluate whether~     incident DM (expected rate 3.5%/year) or incident HT is reduced 25% by ACEI and ARB versus~     placebo (primary hypothesis) and whether either the ACEI or the ARB reduces incident DM by~     30% more than the other agent.~   "
236714|NCT00456950|"~     Despite advances in prevention and treatment, clinical manifestations of atherosclerosis~     (e.g. myocardial infarction, stroke) remain the largest cause of mortality in the Western~     world. The occurrence of acute ischemic syndromes, including unstable angina and myocardial~     infarction, is highly associated with atherosclerotic plaque morphology.~      Magnetic resonance (MR) imaging is able to noninvasively depict the lumen of coronary~     arteries without the need for ionizing radiation. In addition, MR imaging is able to generate~     soft-tissue contrast unlike any other imaging modality. It has been shown in the aorta and~     carotid artery that MR imaging is able to identify different atherosclerotic plaque~     components in vivo. Similar MR imaging techniques are becoming available to visualize the~     coronary arterial wall and preliminary studies have shown the feasibility of MR coronary~     vessel wall imaging in humans.~      The overall aim of the current study is to identify in vivo MR coronary vessel wall and~     plaque features that are associated with acute coronary syndromes. This study is divided into~     2 substudies:~        1. Detection of atherosclerosis in the coronary vessel wall with contrast-enhanced MR~          imaging in patients with coronary artery disease and age-matched healthy volunteers.~        2. Characterization of coronary vessel wall plaque morphology in patients with stable and~          unstable angina: validation of MRI with the current standard of reference intravascular~          ultrasound (IVUS).~   "
236715|NCT00456937|"~     SSRI's has been demonstrated to be partially effective in schizophrenia and OCD. We therefore~     suggest that Escitalopram up to 20 mg /d in those patients could be effective in reducing~     obsessive compulsive symptomatology~   "
236716|NCT00456924|"~     The purpose of the present study is to evaluate continuous administration of low doses of~     VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid~     hormone parameters.~   "
236717|NCT00456911|"~     We hypothesize that Family Dietary Coaching for one school year will allow a nutritional~     shift towards following recommendations and improve health indicators in free-living children~     and adults.~   "
236718|NCT00456898|"~     To evaluate the effects of multiple oral doses of desvenlafaxine sustained release (DVS SR)~     and paroxetine on the biotransformation of codeine to morphine in healthy subjects. To assess~     the safety and tolerability of DVS SR and paroxetine when coadministered with codeine to~     healthy subjects.~   "
236719|NCT00456885|"~     This study will look at the effect of exenatide, a drug which has been approved for the~     treatment of type 2 diabetes, on body weight, appetite and energy expenditure among~     moderately obese women without diabetes.~      The study is 35 weeks long and includes 19 outpatient visits. Participants will receive~     exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither~     participants nor investigators will know whether exenatide or placebo is being administered.~     Participants will be started randomly on either exenatide or placebo.~      Our hypothesis is that treatment with exenatide will curb appetite and lead to weight loss~     and may lead to changes in energy expenditure.~   "
236720|NCT00456872|"~     Oncology patients require numerous invasive procedures throughout their disease process~     including bone marrow biopsies (BMB). BMB.s are performed by a significant number of health~     care providers. One of the biggest concerns for health care providers is to improve patient~     comfort. The goal of this study was to reduce pain during BMBs.~      Specific aims of the study were to determine if there is a difference in patients' perceived~     pain during injection of the pre-procedure anesthetic when buffered versus unbuffered~     lidocaine is administered to patient's receiving bone marrow biopsies.~      A double blind, experimental crossover design was used to examine the difference in pain~     levels when using buffered versus unbuffered lidocaine prior to the bilateral bone marrow~     biopsy procedure. Based on a power analysis for a paired t-test, a convenience sample of 48~     patients was enrolled into the study. Patients served as their own control. The site of first~     biopsy, and which lidocaine solution was administered first, were randomized. A 100mm visual~     analogue scale (VAS) was used to measure pain.~      All data has been collected, are currently under analysis, and results will be completed in~     August 2006. Differences in groups will be examined using a paired t-test. A demographic~     questionnaire was used to gather select demographic variables. Correlative studies will be~     done to examine the relationship between the patient's perceived pain scores and several~     exploratory variables. Results of this study may change the current type of anesthetic used~     pre-BMBs thus improving patient comfort.~   "
236721|NCT00456859|"~     The CAP-KD trial is a prospective, multicenter, randomized, open-label, two-arm, parallel~     group comparison clinical trial and will be conducted as a researcher-directed study to~     assess the efficacy of Kremezin in preventing the progression of CKD. We compare two groups~     of patients: those receiving conventional treatment alone and those receiving such treatment~     paired with Kremezin.~   "
236722|NCT00456846|"~     The purpose of this study is to determine the toxicity and anti-tumor activity of~     nab-paclitaxel 100mg/m^2 administered weekly in a 4-week cycle as first line therapy to~     patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy~     and patients who did not receive taxanes as part of their adjuvant therapy.~   "
236724|NCT00456820|"~     The purpose of this study is to find out differences in activation of mood regulating areas~     of the brain in response to negative and positive pictures, before and after 6 weeks of~     additional Wellbutrin XL treatment. Participants should have been treated for depression with~     an SSRI medication (e.g., Prozac, Zoloft, Paxil, Celexa or Lexapro) and have decreased~     depression symptoms but also be experiencing side effects of medications such as sexual side~     effects and feelings of apathy (indifference, lack of interest) and lack of full emotional~     response. We will first take a brain scan to measure activity in different parts of the~     brain, while subjects are seeing pictures, using Magnetic Resonance Imaging (MRI) scan. Then~     we will add Wellbutrin XL - another well-known antidepressant that acts by increasing the~     chemical dopamine in the brain, to subjects' treatment. Wellbutrin addition is useful in~     decreasing the sexual side effects of SSRIs. After treatment with Wellbutrin XL for 6 weeks~     subjects will have a second MRI scan with picture rating.~   "
236725|NCT00456807|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the~     uterus or womb). This infection may go away by itself, but if it does not go away (this is~     called persistent infection), it can lead in women over a long period of time to cancer of~     the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and~     immunogenicity of the vaccine in women aged 26 years and above. This study will therefore~     assess additional immunogenicity parameters of the vaccine in women from selected~     investigative sites.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
236726|NCT00456794|"~     A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and~     efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time~     phenomena and advanced Parkinson's disease treated with levodopa/carbidopa.~   "
236727|NCT00456781|"~     This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product~     used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright~     Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human~     dermis. The primary purpose of this study is to determine whether rotator cuff repair~     augmentation using GraftJacket allograft provides a viable alternative, based on observed~     clinical outcomes, versus outcomes traditionally achieved with suture and anchor repairs. The~     study will secondarily investigate the difference in outcomes in patients treated~     arthroscopically versus open. This study will report patient progress and results at early (6~     month) and late (2 year) time points in patients treated for large and massive reparable~     rotator cuff tears (>3cm). A reparable tear is defined as a tear of the rotator cuff where it~     is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus~     without excessive tension. Restoration of rotator cuff integrity, clinical outcomes and~     re-tear rate will be included in the study evaluations.~   "
236728|NCT00456768|"~     The purpose of these questionnaires is to give us an overview of how panic has affected your~     life and perhaps also to give us some clues about things that may have set you up to~     experience panic.~   "
236729|NCT00456755|"~     Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The~     conventional therapies are effective in alleviating symptoms but the efficacy are limited and~     not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese~     herbal formula, has been used for AR for centries. Our study purpose is to evaluate the~     clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis~     (PAR).~      Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and~     change some immunological parameters in the peripheral blood when comparing with the placebo.~   "
236730|NCT00456742|"~     The purpose of these questionnaires is to give us an overview of how GAD has affected your~     life, and perhaps also to give us some clues about things that may have set you up to~     experience GAD.~   "
236731|NCT00456729|"~     Infants should receive prophylacatic iron supplementation since age 4 months till one year.~     Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency~     resistent to further iron treatment. The purpose of this study is to assess the incidence of~     malabsorption in those infants and to examine the results of empiric treatment with~     metronidazole.~   "
236732|NCT00456716|"~     Open label study of sorafenib~   "
236733|NCT00456703|"~     Liberal intravenous fluid resuscitation during open abdominal surgery may predispose the~     patients to multiorgan dysfunction, prolong hospital stay and increase postoperative~     morbidity. The main aim of the study is to assess the safety and feasibility of restricted~     fluid regimen in open abdominal bowel surgery.~   "
236734|NCT00456690|"~     B Thalassemia patients developed short stature and low weight in spite no evident endocrine~     abnormalities. One hypothesis is that they developed some degree of malnutrition,then the~     purpose of this study is to assess the nutritional status before nutritional intervention and~     after one year. Siblings of the patients will serve as a control group.~      BMI, lipid and endocrine profile and leptin levels will be analysed in the study group only.~   "
236735|NCT00456677|"~     Trial of effects of minocycline as add-on therapy to adults with asthma with a history of~     requiring at least one episode of oral steroid therapy to control the disease.~   "
236736|NCT00456664|"~     Various diagnostic methods are available for CMV infection. But none of them could be a~     standard and highly valuable. Our first goal is to setup a series of molecular diagnostic~     tools for HIV-1 infected person. By using these tools, physicians can easily select cases~     with CMV disease or immune restoration inflammatory syndrome (IRIS) to enroll this study.~     Furthermore, we will seek for a predict marker for CMV reactivation, CMV disease and IRIS.~     Finally, our research will focus on the mechanism of the IE gene alternative splicing between~     lytic and latent stage.~   "
236737|NCT00456651|"~     The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome~     have different pattern in the secretion of hormones.~      The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome~     (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic~     balance, causing an alteration in the secretion of hormones that favour the appearance and/or~     development of obesity.~   "
236999|NCT00453180|"~     The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC)~     will improve behavior problems often associated with autism spectrum disorders.~   "
236739|NCT00456625|"~     The current study will evaluate immunological memory to hepatitis B antigen in subjects who~     received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in~     the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values~     at the previous long-term time point. All participating subjects will receive a challenge~     dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of~     this study. No new subjects will be recruited in this long-term follow-up study. Blood~     sampling will be done one month after the administration of the challenge dose. The Protocol~     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
236740|NCT00456612|"~     Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses~     (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly-~     particularly in patients who are generally in poor performance status (KPS<70). Fractionated~     Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor~     control in a much shorter and tolerable schedule improving their quality of their short life.~      To assess the tolerability of Cyberknife Radiosurgery for High Grade Gliomas in Elderly with~     poor performance status.~      Secondary:~      Assessment of local control rate, progression free survival, overall survival, quality of~     life and toxicity and steroid dependence in this population with this regime.~   "
236741|NCT00456599|"~     This study will examine a sequence of treatments including pre-operative chemotherapy and~     radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.~   "
236742|NCT00456586|"~     12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate~     the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with~     OFF phenomena advanced PD who were treated with levodopa/carbidopa.~   "
236743|NCT00456573|"~     The purpose of this study is to compare the cytokine profile of tonsillar and peripheral~     blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the~     blood mononuclear cell cytokine secretion profile between patients with obstructive sleep~     apnea and controls without apnea.~   "
236744|NCT00456560|"~     The purpose of this study is to evaluate the effects that paroxetine and fluvoxamine have on~     the way the body distributes, breakdowns and eliminates AV650. In addition, information about~     any side effects that may occur will also be collected.~   "
236745|NCT00456547|"~     The purpose of this study is to examine components of the coagulation system in women~     undergoing postpartum hysterectomy and to compare laboratory parameters of coagulation in~     these women to women at increased risk for a postpartum hysterectomy, but who do not have~     postpartum hemorrhage and a postpartum hysterectomy. During normal pregnancy, the hemostatic~     balance tips toward hypercoagulation. Non-obstetric surgical blood loss is associated with~     increased coagulation activity. We have observed that women undergoing a postpartum~     hysterectomy become hypocoagulable secondary to a consumptive coagulopathy and/or excessive~     fibrinolysis. This coagulopathy may lead to the administration of multiple blood products.~     Worldwide, postpartum hemorrhage is a leading cause of maternal death. Plasma levels of~     tissue plasminogen activator, urokinase plasminogen activator and their inhibitors increase~     during pregnancy. During labor and delivery activation of coagulation occurs with consumption~     of platelets, coagulation factors and inhibitors. Obstetric complications during delivery can~     excessively activate the coagulation system and disseminated intravascular coagulation may~     ensue. Current treatment for postpartum coagulopathy is non-specific and primarily consists~     of replacing blood components. If specific causes or markers of abnormal coagulation can be~     identified in women at risk, then it might be possible to target (with specific medications)~     specific abnormalities early in the process and decrease hemorrhage and the need for blood~     transfusions.~   "
236746|NCT00456534|"~     The purpose of the experiment is to examine the effect of smoking on how individuals~     recognize and interpret sensory information.~   "
236747|NCT00456521|"~     The purpose of this study is to determine whether a combination of naltrexone SR and~     bupropion SR is safe and effective in treating obesity and leads to greater weight loss when~     given with a group lifestyle modification program than with group lifestyle modification~     alone.~   "
236748|NCT00456508|"~     The purpose of this study is to evaluate the efficacy and safety of repeated doses of~     ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE~     patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4)~     trial will be followed up and treated for subsequent attacks in this trial.~   "
236749|NCT00456495|"~     The purpose of this study is to test the safety and tolerability of subconjunctival injection~     of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and~     severity of adverse events.~      Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant~     conjunctival neoplasia by evaluating tumor destruction or reduction as documented by~     slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.~   "
236750|NCT00456482|"~     This is a multi-center, randomized, double-masked, controlled study to evaluate the safety~     and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects~     with non-infectious uveitis affecting the posterior segment of the eye. An additional~     objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.~   "
236751|NCT00456469|"~     Study based in Southern Ethiopia Purpose - to explore if children in contact with adults with~     TB have positive acute reactants such as IFN-y and other cytokine responses; if these~     responses discriminate between high and low risk of disease progression and whether these~     could be incorporated into improved diagnostic approaches.~   "
236752|NCT00456456|"~     Online survey for 11-17 year olds about behavior, sleep, and food consumption patterns. This~     survey can be completed on any computer that has internet access.~   "
236753|NCT00456443|"~     Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections,~     principally those patients that underwent splenectomy. Since the introduction of anti~     pneumococcal vaccine the incidence decreased significantly but other bacteria besides~     encapsulated bacteria takes place as principal cause of invasive infections. The purpose of~     this study is to analyse in a retrospective study the incidence of those infections in a~     group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.~   "
236754|NCT00456430|"~     The purpose of this study is to find out what parts of the brain have increased or decreased~     activity when people are depressed and how antidepressant medicine changes this activity in~     depressed patients.In particular, this study will investigate whether variation in the~     serotonin transporter gene can affect the response to escitalopram as measured by clinical~     interview and MRI scan. We will measure activity in different parts of the brain, while~     subjects see pictures, using Magnetic Resonance Imaging (MRI) scan. There will be three MRI~     scans; one before we start any medication, one during the study after 3 weeks of treatment~     and one after six more weeks of treatment. Treatment will consist of Escitalopram.~     Additionally a blood sample will be taken for genetic testing. The genetic samples collected~     are to look at variation in a gene (serotonin transporter gene), which affects the~     functioning of the chemical serotonin in the brain.~   "
236755|NCT00456417|"~     The underlying goal of this study is to assess 123-I MNI-187 SPECT imaging as a tool to~     detect ß-amyloid deposition in the brain of AD research participants and age- and~     gender-matched healthy subjects.~   "
236756|NCT00456404|"~     To evaluate the effectiveness of a topical preparation of peppermint water in comparison with~     that of expressed breast milk for the prevention of nipple cracks in primiparous~     breastfeeding women.~   "
236757|NCT00456391|"~     Pediatric patients are admitted to the emergency room for diverse causes, beside trauma,~     patients can present with convulsions, suspicion of brain tumor or increased intracranial~     pressure. In most of the cases a brain CT is performed even before physical examination by a~     skilled neurologist. The amount of radiation that the children are exposed is equivalent to~     100 plain chest X rays. The purpose of this tudy is to examinate in a retrospective study~     what were the indications for CT study and what was the incidence of relevant abnormal~     findings that required emergency intervention or referral.~   "
236758|NCT00456378|"~     The purpose of this study is to establish the safety and effectiveness of the DIAM™ Spinal~     Stabilization System in the treatment of moderate single-level lumbar degenerative disc~     disease.~   "
236759|NCT00456365|"~     The purpose of this study is to determine whether the medication pravastatin will ameliorate~     renal and cardiovascular disease over a 3-year period in children and young adults with~     autosomal dominant polycystic kidney disease (ADPKD).~   "
236760|NCT00456352|"~     Evaluation of duodenal exclusion procedure for the treatment of T2DM~   "
236761|NCT00456339|"~     The purpose of this study is to investigate the effect of treatment with a steroid and~     antibiotic on the size of the tonsils and symptoms of children with OSAS.~   "
236762|NCT00456326|"~     The purpose of the Heparin Induced Thrombocytopenia Registry is to explore the frequency of~     heparin-induced thrombocytopenia (HIT) at Brigham and Women's Hospital and to assess its~     mortality rate. Retrospective 3 years, looking forward prospectively.~   "
236763|NCT00456313|"~     This multi centre, double blind, comparator controlled, parallel group study is to determine~     whether asthma treatment with high doses of fluticasone propionate (FP) redirects a Th2/~     eosinophil response towards a more treatment resistant neutrophil/ monocyte response and~     whether this occurs to a lesser extent in asthmatic subjects treated with the combination~     product of salmeterol and fluticasone propionate (SFC). The primary endpoint is the mean~     change in priming of blood neutrophils assessed by marker A17. After a run-in period of 4~     weeks subjects will enter a 24 weeks high dose treatment (FP 500 mcg bd) or a 12 week~     medium-dose treatment with FP 250 mcg bd followed by a 12 week treatment with SFC 50/ 250~     mcg. At the visits lung function measurements, ACT, eNO measurements and a blood sample will~     be performed. A total of 50 randomised subjects are planned to be recruited in this study~   "
236764|NCT00456300|"~     The purpose of this study is to see if giving exenatide and insulin before a meal would lower~     blood sugars after the meal. This study may help in developing new treatments to help control~     high blood sugars after meals. This may help improve overall blood sugar control and prevent~     the long-term problems of diabetes.~   "
236765|NCT00456287|"~     The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet~     function markers and endothelial dysfunction in patients with SAHS before and after treatment~     and normal controls age and weight matched.~   "
236766|NCT00456274|"~     The purpose of the study is to explore the way in which gonadotropins (pituitary hormones)~     are released into the body. The knowledge acquired in this study will be used for the~     diagnosis and treatment of reproductive endocrine disorders.~      We seek to investigate the baseline characteristics of the GnRH-induced gonadotropin~     pulsations of patients with the following diagnoses:~        -  Hypothalamic Amenorrhea (HA)~        -  Idiopathic hypogonadotropic hypogonadism (IHH)~        -  Polycystic ovarian disease (PCOD)~        -  Acquired hypogonadotropic hypogonadism (AHH)~        -  Premature Ovarian Failure (POF)~      **WE ARE CURRENTLY RECRUITING ONLY SUBJECTS WITH A DIAGNOSIS OF IHH.**~      This has been an extremely productive and pivotal protocol in the studies of female~     reproductive physiology and pathophysiology and continues to be critical for defining the~     neuroendocrine abnormalities in patients with reproductive disorders. In some cases, it is~     also helpful in the planning of subsequent therapy if so desired.~      It is important to note that minors have been included in this protocol, as many patients are~     extremely anxious to know more about their neuroendocrine disorder. With minors who would~     like to know if their disorder is correctable, this protocol may be followed up with~     administration of pulsatile gonadotropin-releasing hormone (GnRH).~   "
236767|NCT00456261|"~     This trial will look at 2 different drug combinations that have well known safety profiles~     and are known to be active against non small cell lung cancer and combine them with~     bevacizumab, an experimental drug that has shown effectiveness when added to other drug~     combinations for advanced non-small cell lung cancer. The primary objective in this study is~     to see how well this combination of drugs keeps the cancer from getting worse in this elderly~     population of non-small cell lung cancer patients.~   "
236768|NCT00456248|"~     This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with~     Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and~     Ribavirin therapy. The study will be conducted at approximately 50 sites across the United~     States.~   "
237014|NCT00452985|"~     Primary objective:~      To assess response rate. To record the clinical improvement in relation to stage and~     histopathological grading.~      Secondary objective:~      To determine progression free survival. To find out overall survival. To evaluate the safety~     of the study regimen.~   "
236769|NCT00456235|"~     The aim of this project is to determine whether, in liver transplant patients with side~     effects due to ICN, the use of MMF in monotherapy can be optimised by dose adjustment based~     on the area under the curve (AUC) of mycophenolic acid (MPA). It involves a multicentre phase~     IV trial with direct individual benefit.~      A population of 130 liver transplant patients at 2 to 10 years post-transplant, showing~     significant clinical ICN side effects and being given bitherapy by ICN +MMF will be included~     and randomised 1:1 in two arms:~        -  Arm 1: progressive interruption of ICN after obtaining an AUC of MPA of 50 mg.h/l,~          followed by MMF monotherapy with dose adjustment based on the AUC of MPA,~        -  Arm 2: continuation of the ICN+MMF bitherapy without MMF therapeutic drug monitoring.~      The main judgement criterion will be the incidence of acute rejection in the 2 groups at 6~     months. The secondary judgment criterion will be the evaluation of the benefit of stopping~     ICN on the side effects caused by these drugs.~   "
236770|NCT00456222|"~     The purpose of this study is to investigate whether sleep disruption affects menstrual cycle~     timing~   "
236771|NCT00456209|"~     The purpose of this phenomenological study is to discover and illuminate the experiences of~     adolescents in the treatment process of cancer and the meanings they attach to these~     experiences, while maintaining their daily routines. The focus area of interest lies in the~     impact side-effects (psychological and physical) which these treatments may have on an~     individual's ability to participate with peers, maintain social activities, and be involved~     in daily occupation(s).~   "
236772|NCT00456196|"~     More than 5 years ago the DVT FREE Registry was conceived. Its database consists of 5,451~     ultrasound-confirmed DVT patients from 183 institutions. This database is rich in information~     of critical importance to health care providers. The information contained within the~     database will be revisited to provide more detailed analyses which will be used for risk~     factor assessment and for decision-making regarding the implementation of VTE Prophylaxis.~   "
236773|NCT00456183|"~     This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who~     are latently infected with M.tb. A single vaccination with MVA85A, when administeredat a dose~     of 5 x 107pfu intradermally, is safe in both mycobacterially naïve individuals and those~     previously vaccinated with BCG. We will use the same vaccination regime in this study.~     Subjects will be defined as being latently infected if they have a positive elispot response~     to ESAT6 or CFP10. Subjects will be identified from TB contact clinics.~   "
236774|NCT00456170|"~     The hypotheses of this study is that the use of the instrument “Harmonic Scalpel” (ultrasonic~     shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the~     use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced~     blood loss, reduced operating time, reduced post-operative pain and earlier discharge from~     hospital. Other outcome measure will include complications and cost.~   "
236775|NCT00456157|"~     The purpose of this research study is to investigate the safety and tolerability of OP-1 when~     it is injected into the knee joint of patients who have osteoarthritis on the knee.~   "
236776|NCT00456144|"~     The purpose of this research study is to find out if a certain type of hormone therapy,~     gonadotropin-releasing hormone agonist (GnRH agonist), affects the way the body produces and~     responds to insulin. The investigators will evaluate the changes in insulin sensitivity~     during and after GnRH agonist treatment for prostate cancer. The investigators are assessing~     the possibility that treatment-related insulin resistance may contribute to the risk of~     diabetes and/or cardiovascular disease in men with prostate cancer.~   "
236777|NCT00456131|"~     This is a nutrition and behavior-based intervention conducted at Drexel University and the~     University of Pennsylvania with college women during their freshman year. It involves~     attending groups where life skills and eating behaviors are taught to help them control their~     weight and physical health.~   "
236778|NCT00456118|"~     Justification:~      We have recently demonstrated that maternofetal alloimmunization was not limited to blood~     cells: maternal alloimmunization against a glomerular podocyte antigen expressed by the~     placenta can induce neonatal membranous glomerulonephritis.~      Early recurrent pregnancy losses, preeclampsia and intervillositis are obstetrical~     pathologies which share an anomaly of placentation. Pathophysiology of these diseases is not~     yet fully understood; nevertheless the hypothesis of an incompatibility between mother and~     child is often mentioned. The aim of this project is to detect and study the cases of~     recurrent pregnancy losses, preeclamspia and intervillositis which could be induced by~     tissular maternofetal alloimmunization.~      Materials and methods:~      Patients suffering from recurrent pregnancy losses of unknown origin, preeclamspia or~     intervillositis will be included in this project. Mothers’ sera will be studied by indirect~     immunofluorescence and Western Blot on placental biopsies from different origins and~     gestational ages. This stage will enable us to detect possible maternal allo-antibodies.~     After detecting and revealing antibodies, nature of the target antigen will be identified by~     immunoprecipitation of placental extracts, using the positive sera. Immunoprecipitation will~     be followed by a mass spectrometry analysis of detected proteins.~      Expected results:~      This study will enable us:~        -  to detect new cases of tissular maternofetal alloimmunization~        -  to improve our knowledge of mechanisms leading to anomalies of placentation~        -  to carry out a specific, preventive therapeutic approach for cases induced by tissular~          alloimmunization.~      Key words:~      Recurrent pregnancy losses, Preeclampsia, Intervillositis, maternofetal alloimmunization.~   "
236779|NCT00456105|"~     Diabetes is a very common illness. Approximately 4% of British Columbians have diabetes.~     However, at least 20% of people admitted to acute care hospitals have diabetes. People with~     diabetes are at a higher risk for developing complications after surgery including infection~     and prolonged hospital stay, especially if blood sugars are high.~      The researchers are testing a Diabetes Action Team to see if their involvement in patient~     care after surgery improves blood glucose control, duration of stay in hospital, and~     infection rates.~   "
236780|NCT00456092|"~     This study is to look at the preliminary efficacy and safety of CC-10004 vs placebo in~     patients with active psoriatic arthritis. The pharmacokinetics of the compound in patients~     will also be explored, and biopsies will be taken of the skin and the knee synovium to look~     at the activity of the drug in the relevant tissues.~   "
237052|NCT00452452|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not~     previously been immunized with Pneumococcal vaccine.~   "
236781|NCT00456066|"~     Distal embolization can occur during coronary angioplasty performed in the acute phase of~     myocardial infarction and is associated with poor long-term outcome. We hypothesize that the~     use of a system allowing thrombus aspiration before angioplasty and stent implantation will~     limit infarct size and its severity.~   "
236782|NCT00456053|"~     The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of~     patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.~   "
236783|NCT00456040|"~     The purpose of this study is to describe the characteristics of patients with amyloidosis and~     severe heart failure being evaluated for cardiac and stem cell transplantation.~   "
236784|NCT00456027|"~     This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in~     Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune~     Diabetes in Adult (LADA).~   "
236785|NCT00456014|"~     This study will use pre-treatment positron emission topography and functional magnetic~     resonance imaging scans of the brain to predict the most effective antidepressant treatment~     for people with major depressive disorder.~   "
236786|NCT00456001|"~     Patients at BWH receiving unfractionated heparin or enoxaparin who subsequently develop~     heparin induced thrombocytopenia will be identified via a computer generated report designed~     for the purposes of this study.~      Subsequently, we will compare the heparin induced thrombocytopenia rates associated with~     heparin and low molecular weight heparin usage as well as evaluate the economic and long-term~     clinical burden of heparin induced thrombocytopenia.~   "
236787|NCT00455988|"~     In order to manage of type 2 diabetic patients with irregular lifestyle, developement of an~     appropriate questionnaire to evaluate a regularity of lifestyle is necessary.~   "
236788|NCT00455975|"~     This trial will examine the effectiveness and the side effects of 2 higher dosing schedules~     of bevacizumab in patients that have advanced clear cell renal carcinoma.~   "
236789|NCT00455962|"~     The purpose of this study is to attempt to determine why estrogen levels are increased in~     African-American women as compared to Caucasian women by evaluating estrogen feedback on the~     brain. African-American women have increased bone mineral density, higher rates of twins,~     greater incidence of fibroids, and increased incidence of breast cancer below 40 years of age~     as compared to Caucasian women. These traits or illnesses are all believed to be~     estrogen-dependent. In fact, previous research has demonstrated increased estrogen levels in~     African-American women as compared to Caucasian women. However, the reason for these~     differences in estrogen levels has not been studied in humans. One possibility is that~     estrogen feedback on the brain differs between African-American and Caucasian women. Two~     small glands in the brain (hypothalamus and pituitary) respond to estrogen. The hypothalamus~     secretes GnRH (Gonadotropin-Releasing Hormone) that signals the pituitary to secrete the~     reproductive hormones, LH (Luteinizing Hormone) and FSH (Follicle Stimulating Hormone). These~     hormones act on the ovaries and signal the ovaries to produce estrogen and progesterone.~     Estrogen in the bloodstream then acts on the brain to stop this system when the blood has~     enough estrogen levels. This is called estrogen feedback. This study will determine whether~     there are differences in estrogen feedback between African-American and Caucasian women.~   "
236790|NCT00455949|"~     Analyze the possible effect of the progesterone levels of the hCG administration on the~     oocyte embryo quality. The primary endpoint of this study is the pregnancy rate.~   "
236791|NCT00455936|"~     The investigators will conduct the randomized trial to determine the role of Gefitinib~     monotherapy as first-line setting in adenocarcinoma patients with no history of smoking, as~     compared with the standard combination chemotherapy.~      This is a randomized, open label, parallel group, phase III study in never-smokers with~     advanced or metastatic adenocarcinoma of lung.~      After stratification by gender, performance status, and disease stage, patients will be~     randomized to one of the two treatment arms to receive either gefitinib or standard~     chemotherapy until clinical or objective disease progression, unacceptable toxicity or~     patient's refusal, whichever is sooner. The chemotherapy will be administered for no more~     than nine cycles.~   "
236792|NCT00455923|"~     An 18 months randomised double-blind study with two parallel arms with start dose of inhaled~     SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be~     up-titrated until well controlled is achieved, After 6 months the treatment continues without~     changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that~     the combination therapy with SERETIDE controls mild persistent asthma better than inhaled~     corticosteroids(FLIXOTIDE) alone.~   "
236793|NCT00455910|"~     The GFM previously conducted a dose-escalating phase II trial of thalidomide in MDS with a~     minimum dose of 200mg/d and a maximum dose 800mg/d. Responses were evaluated according to IWG~     criteria at week 16 and thalidomide continued up to week 56 in responders. 82% patients~     received at least 8 weeks of treatment and were evaluable. 59% had hematological improvement,~     mainly on the erythroid lineage (Increase of Hemoglobin). Most responses were observed at low~     doses and between 4 and 8 weeks.~      The objectives of this trial (Thal-SMD-20) are to evaluate the efficacy and tolerance of~     lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia.~   "
236794|NCT00455897|"~     The primary goal of this study is to determine the effects (good and bad) of~     Granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with Cytoxan,~     Adriamycin, Vincristine, Prednisone, Rituximab (CHOP-R) on diffuse Large B cell Non-Hodgkin's~     lymphoma (DLBCL). The standard of care for DLBCL is the combination of drugs known as~     CHOP-Rituximab (CHOP-R). The drugs that make up CHOP-R are the chemotherapy drugs~     cyclophosphamide, doxorubicin and vincristine, prednisone and rituximab. GM-CSF is a drug~     that stimulates the immune system by increasing the numbers of white blood cells. Previous~     research has shown that GM-CSF might help rituximab to be more effective in treating~     lymphoma.~   "
236795|NCT00455884|"~     This study is a multicenter, open-label, observational, post marketing surveillance program~     to collect information on the use of NutropinAq® in adults suffering from Growth Hormone~     Deficiency in Germany, Italy, and United Kingdom~   "
236796|NCT00455871|"~     The purpose of this study is to determine the benefits, if any, of combination therapy with~     Lucentis plus reduced fluence photodynamic therapy with Visudyne.~   "
237261|NCT00449696|"~     The purpose of this study is to determine if a single intra-articular injection of Gel-200 is~     superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with~     symptomatic osteoarthritis of the knee.~   "
236800|NCT00455819|"~     The aim of this study is to investigate the safety of treatment of pulmonary embolism in an~     outpatient setting based on normal pro-BNP levels. The mortality rate and the incidence of~     hemodynamic instability as well as major bleeding and recurrent venous thromboembolism (VTE)~     in the outpatient group will be studied.~   "
236801|NCT00455806|"~     Successful H. pylori eradication therapy remains a challenge in medical practice. Despite~     promising data for first-line, second-line and rescue treatment options based on clinical~     trials as well as guidelines and expert recommendations, success rates can often not be~     reproduced in general practice. Rescue options for patients with failed initial or~     second-line therapy are definitely needed. The new fluoroquinolone moxifloxacin may represent~     an effective and save treatment option (in combination with a PPI and amoxicillin) for rescue~     therapy of H- pylori positive patients.However, optimal duration of therapy (7-day course vs~     14-day course) has to be determined~   "
236802|NCT00455793|"~     We will obtain data using multi-slice CT technology to detect subclinical coronary disease in~     the HIV population. Determination of subclinical cardiovascular disease using noninvasive~     technology and elucidation of the associated risk factors will help to guide targeted therapy~     to prevent cardiovascular events in this patient population.~      We will investigate the prevalence of coronary plaque lesions and coronary artery~     calcifications in men and women with HIV disease as determined by 64-row multidetector~     computed tomography (MDCT) and MDCT coronary angiography in comparison to age-matched control~     subjects without HIV infection. We hypothesize that evidence of coronary artery calcification~     and coronary plaque lesions as seen by MDCT will be present in individuals with HIV more than~     non-HIV control subjects of the same age. We also hypothesize the degree of atherosclerosis~     will be increased in HIV patients compared to control subjects.~      We will evaluate the metabolic and inflammatory factors associated with coronary artery~     disease in HIV-infected individuals. We hypothesize that traditional cardiac risk factors as~     well as metabolic and inflammatory changes associated with HIV and its treatment such as~     dyslipidemia, increased secretion of inflammatory markers, decreased adiponectin, increased~     insulin resistance and increased visceral fat may be associated with coronary artery disease~     in HIV-infected individuals.~   "
236803|NCT00455780|"~     After a three month weight loss phase involving the use of meal replacements, participants~     are randomized into different weight loss maintenance conditions. Aim 1: To test the~     hypothesis that the meal replacement (MR) and reduced energy density eating (REDE)~     interventions, when added separately to the LEARN program, will produce superior weight loss~     maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the~     weight loss maintenance condition that combines MRs and REDE will produce better maintenance~     of weight losses than either individual component and than the LEARN-only condition. Aim 3:~     To test the hypothesis that the two conditions receiving the REDE intervention will~     experience longer-lasting improvements in the energy density and nutritional composition of~     the diet compared to the two non-REDE conditions.~   "
236804|NCT00455767|"~     The study is aimed to assess safety of Depelestat treatment, as well as efficacy on~     prevention and treatment of alveolar inflammation in early pulmonary fibrosis in patients~     suffering from persistent Acute Respiratory Distress Syndrome.~   "
236805|NCT00455754|"~     The purpose of this study is to determine whether treatment with esomeprazole alone is able~     to heal patients with lymphocytic gastritis~   "
236806|NCT00455741|"~     The purpose of the study is to study the effects of aging, estrogen and progesterone on the~     brain. Specifically, we want to look at how the hypothalamus and pituitary (two small glands~     in the brain) respond to estrogen. The pituitary gland is controlled by the hypothalamus. The~     hypothalamus secretes GnRH (Gonadotropin-Releasing Hormone) that signals the pituitary to~     secrete the reproductive hormones, LH (Luteinizing Hormone) and FSH (Follicle Stimulating~     Hormone). These hormones act on the ovaries and signal the ovaries to produce estrogen and~     progesterone. Estrogen in the bloodstream then acts on the brain to modulate this system with~     changes in LH and FSH. Early changes associated with low levels of estrogen are inhibitory~     (estrogen negative feedback) while higher levels of estrogen (such as those present when a~     follicle in the ovary is ready to ovulate) stimulate LH to cause ovulation (positive~     feedback). This study will determine: 1) hypothalamic and pituitary levels of glucose uptake~     (as a measure of brain metabolic activity) at baseline and in association with estrogen~     negative feedback on LH (24 hr) and estrogen positive feedback on LH (72 hr); and 2) the~     effect of aging on estrogen feedback on LH, assessing negative feedback (nadir ~ 24 hr) and~     positive feedback (peak between 72 and 96 hr).~   "
236807|NCT00455728|"~     This study is a multicenter, open label, observational, post marketing surveillance study of~     NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect~     long-term safety and effectiveness information on NutropinAq® during treatment of paediatric~     growth disorders.~   "
236808|NCT00455715|"~     The study is a double-blind, placebo-controlled, random-order, single-dose crossover trial of~     sildenafil 50 & 100 mg added to stable antipsychotic treatment in schizophrenia patients to~     assess whether this PDE5 inhibitor improves cognitive functioning (including verbal memory,~     fluency, attention, spatial memory, motor speed, and executive function) and clinical~     symptoms (psychotic, negative, mood symptoms, and self-reports of side-effects).~   "
236809|NCT00455702|"~     The study aims to assess the effects of single dose and repeated weekly dosing of 50mg~     d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients.~     The study will also examine the effects of 50mg d-cycloserine on positive symptoms and~     negative symptoms, as well as assess tolerability and side-effects.~   "
236810|NCT00455689|"~     The purpose of the study is to examine the impact of hot flushes on sleep, mood, and~     well-being. Hot flushes (or hot flashes) are a feeling of being overheated, and often are~     followed by heavy sweating, skin becoming red and hot, and discomfort. Sometimes hot flushes~     are followed by chills. Some women experience a rapid heart rate. Hot flushes that happen at~     night are called night sweats, and they may interfere with sleep.~      The investigators will cause hot flushes by giving study participants a hormone medication~     called leuprolide (Lupron). Hormones are chemicals that are naturally produced in the body.~     Leuprolide is a manufactured (artificial) hormone that will make the body think that it has~     reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after~     taking leuprolide.~      The investigators will also evaluate changes in sleep, mood, and feelings of well-being over~     the course of the study. The investigators will use questionnaires to measure these changes.~   "
236811|NCT00455676|"~     Comparison between two techniques of osteotomy wich are more or less invasive : two criterias~     : clinical data and x-rays data.~      All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone~     surgery CHU Limoges :~        -  Scarf or Jonhson (chevron) osteotomy~        -  Experienced surgeon : Pr ARNAUD, Pr MABIT or Pr CHARISSOUX.~   "
236812|NCT00455663|"~     This study will compare the effectiveness of three treatments in improving medication~     adherence, symptoms, and function in people with schizophrenia.~   "
236813|NCT00455650|"~     We are conducting this study to find out if blocking or partially stimulating the effects of~     nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug~     found in tobacco products. Our subjects will be people with and without mental illness~     (schizophrenia), smokers and non-smokers.~      We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on~     the brains of our subjects. We will also use a medication called varenicline (Chantix) to~     partially increase the effects of nicotine on the brains of our subjects. This study also~     uses a placebo, a pill that does not have any active ingredients but looks exactly like the~     mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or~     placebo to people who have schizophrenia and people who do not have schizophrenia.~      We know that people with schizophrenia smoke heavily and find it harder to stop smoking than~     most other people do. Studies have shown that people with schizophrenia may smoke more~     because nicotine helps their concentration and memory. We are interested in helping people~     with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to~     nicotine and varenicline partially stimulates and partially blocks the parts of the brain~     that react to nicotine. Both medications may decrease the effects that smoking has on the~     body.~   "
236814|NCT00455637|"~     The purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15~     Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in~     children/young people.~   "
236815|NCT00455624|"~     The purpose of this study is to find out if androgen deprivation therapy affects insulin,~     cardiac risk factors such as cholesterol level, and body fat and muscle.~   "
236816|NCT00455611|"~     To assess modifications of ventricular function induced by CPAP (Continuous Positive Airway~     Pressure).~   "
236817|NCT00455598|"~     The purpose of this study is to provide an initial assessment of the safety, tolerability and~     efficacy of ISIS 113715 in combination with sulfonylurea in type 2 diabetes subjects.~   "
236818|NCT00455585|"~     This study aims to compare the steady state pharmacokinetics of stavudine, lamivudine, and~     nevirapine in HIV positive Ugandan patients taking Triomune 40 with the pharmacokinetics of~     the originator products known as Viramune, Epivir and Zerit 40.~   "
236819|NCT00455572|"~     The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer~     patients are able to give an immune response to injections of the immunotherapeutic product~     GSK1572932A, and to find out more about the safety of this treatment. A course of eight~     injections will be administered over 21 weeks; including screening for suitability and all~     tests, the duration of the study for a patient will be 30-35 weeks. During this period~     various tests will be performed, including physical examinations and blood tests. The~     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
236820|NCT00455559|"~     This is a Phase II trial designed to determine the efficacy and safety of perifosine plus~     imatinib mesylate in patients with advanced GIST who develop progressive disease or~     recurrence while receiving imatinib mesylate.~   "
236821|NCT00455546|"~     The study will be conducted at up to 80 centers worldwide and will be a double-blind~     randomized parallel group placebo controlled study among subjects with stable coronary artery~     disease (CAD). Subjects will be randomized to receive either placebo tablets or one of 4~     orally active doses of A-002. The duration of study drug therapy will be 8 weeks.~   "
236822|NCT00455533|"~     The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus~     cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin~     plus cyclophosphamide in patients with early stage breast cancer. In addition the study will~     verify predefined biomarkers as well as discover new biomarkers that could identify patients~     who are more likely to respond to ixabepilone than standard paclitaxel based therapy.~   "
236823|NCT00455520|"~     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety~     of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with~     moderate to severe pain from diabetic peripheral neuropathy.~   "
236824|NCT00455507|"~     The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of~     istradefylline for reducing the mean total hours of awake time per day spent in the OFF state~     in patients with advanced Parkinson's disease (PD) treated with levodopa.~   "
236825|NCT00455494|"~     The purpose of this study is to test the safety of a 2100 mg dose of AQ-13, a new candidate~     antimalarial active against drug-resistant P. falciparum infection, and to determine the~     effect of a standard fatty meal on the absorption of the drug from the gut and its blood~     levels.~   "
236826|NCT00455468|"~     Pneumonia is the leading cause of childhood morbidity and death in many developing countries~     including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an~     infection of the lungs, most commonly caused by viruses or bacteria like Streptococcus~     pneumoniae and Haemophilus influenzae. Depending on the clinical presentation, pneumonia can~     be classified as very severe, severe or non-severe, with specific treatment for each of them~     except for antibiotic therapy. Severe and very severe pneumonia require hospitalization for~     additional supportive treatment such as suction, oxygen therapy and administration of~     bronchodilator. In Bangladesh, the number of hospital beds is inadequate for admission of all~     pneumonia cases that require hospitalization; however, it is also important to provide~     institutional care to those children who cannot be hospitalized due to bed constraints.~     Provision of appropriate antibiotics and supportive cares during the period of stay at~     established day-care centres could be an effective alternative. The impetus for this study~     came from the findings of our recently completed study titled Daycare-based management of~     severe pneumonia in under-5 children when hospitalization is not possible due to the lack of~     beds. This study successfully managed children (n=251), but it was not a randomized trial~     and thus direct comparison of the efficacy of management of severe pneumonia at the day-care~     centre, essential for building confidence for implementing this management policy, is not~     possible. We, the researchers at the International Centre for Diarrhoeal Disease Research,~     Bangladesh, could not plan a randomized, controlled trial (RCT) because of ethical reasons.~     Now that we have data suggesting effectiveness as well as safety of the day-care based~     treatment for management of children with severe pneumonia, a RCT should be possible. Two~     hundred fifty-one children with severe pneumonia were enrolled at the Radda Clinic from June~     2003 to May 2005. The mean age was 7±7 (2-55) months, 86% infants, 63% boys and 91%~     breast-fed. History of cough was present in 99% cases, fever in 89% and rapid breathing in~     67% cases. Forty-four percent of children were febrile (≥38°C), 93% children had vesicular~     breath sound and 99% bilateral rales. Fifty-seven percent of children were hypoxic with mean~     oxygen saturation of (93±4)%, which was corrected by oxygen therapy (98±3)%. Eighty percent~     of children had severe pneumonia and 20% had very severe pneumonia. The mean duration of~     clinic stay was (7±2) days. Two hundred thirty-four (93%) children completed the study~     successfully, 11 (4.4%) referred to hospitals (only one participant had to visit hospital at~     night due to deterioration of his condition, 9 were referred to hospital at the time of~     clinic closure i.e., at 5 pm and one participant was referred to hospital during the morning~     hours) and 6 (2.4%) left against medical advice (LAMA). There was no death during the period~     of clinic stay but only four (1.6%) deaths occurred during the 3 months follow-up. The study~     indicated that treatment of severe pneumonia in children at the day-care centre is effective~     and safe and thus it is comparable to the hospital care. If the day-care based management is~     found to have comparable efficacy to that of hospitalized management of severe pneumonia in~     children then they could be managed at outpatient, day-care set ups reducing hospitalization~     and thus freeing beds for management of other children who need hospitalized care.~     Additionally, availability of the treatment facility in community set-ups will be cost and~     time saving for the population. Children of either sex, aged 2-59 months, attending the Radda~     Clinic and Institute of Child Health and Shishu Hospital (ICHSH) with severe pneumonia will~     be randomized to receive either the day-care management at the clinic or hospitalized~     management at the ICHSH. Children randomized to receive day-care treatment will stay at the~     clinic from 8 am-5 pm and will receive antibiotics and other supportive cares. At 5 pm, they~     would be send to respective homes with advice to bring back their children to the clinic next~     morning, and advised to provide other supports at home. The same management would be~     continued till improvement and discharged and followed up every 2 weeks for 3 months.~     Children randomized to receive hospitalized management would be admitted at ICHSH and receive~     standard treatment like antibiotics and other supportive cares. The same treatment would be~     continued for 24 hours/day (rather than 9 hours/day at the day-care clinic) till improvement~     and discharged and followed-up at the ICHSH every 2 weeks for 3 months. About 3000 children~     with pneumonia visit Radda Clinic each year and about 200 of them will have severe pneumonia~     requiring hospitalization. Thus, we hope to enroll 368 (184 in each site) children with~     severe pneumonia during a 2-year study period.~   "
236827|NCT00455455|"~     The primary objective of this study is to compare subjective symptoms and ocular health in a~     group of individuals who are currently wearing soft contact lenses on a daily wear basis,~     after a short period of no lens wear and during the time course when using differing care~     regimens.~   "
236828|NCT00455442|"~     This is a two-week study testing the efficacy and safety of mifepristone in the prevention of~     olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight~     and BMI.~   "
236829|NCT00455429|"~     The purpose of this study is to evaluate the safety and effectiveness of four dose regimens~     (pattern of giving treatment) of JNJ-26113100 in the treatment of adult Atopic Dermatitis~     ([AD]; skin rash, inflammation) that is moderate in severity.~   "
236830|NCT00455416|"~     A dietary intervention study in patients with Follicular Lymphoma (FL) Stage III/IV to assess~     the ability of several dietary factors to induce apoptosis, inhibit cell proliferation and~     modulate tumor cell infiltrate in vivo.~   "
237053|NCT00452439|"~     The goal of this clinical research study is to learn if Actonel (risedronate) can help to~     prevent the development of osteoporosis (brittle and weak bones) caused by the steroid~     medication used to treat leukemia. The safety of this treatment in patients with ALL or LL~     will also be studied.~   "
236831|NCT00455403|"~     Metabolic syndrome consists of a group of co-occuring conditions that increase an~     individual's risk of developing heart disease, stroke, and diabetes. The purpose of this~     study is to evaluate the long-term effectiveness of chloroquine, a protein-activation~     medication, at reducing the progression of atherosclerosis in patients with the metabolic~     syndrome.~      Sub-study: Vascular endothelial growth factor(VEGF)and Cardiometabolic Risk, The purpose is~     to determine if the association of VEGF with atherosclerosis indicates that it should be a~     marker of the disorder.~   "
236832|NCT00455390|"~     Argumentation The frequency of post-traumatic syndrome disorder (PTSD) is estimated around 1%~     of the entire European population. In some specific populations, this percentage increases~     (soldiers – 15 to 22%, war or persecuted refugees – 80%, post office or bank employees~     submitted to an hold-up – 17%, firemen – 10 to 30%, emergency care employees – 11%, people~     who underwent a terrorist attack or any violence – 20 to 65%...)~      Prevention is yet poor, secondary prevention trying to avoid a post traumatic disorder~     apparition early after the traumatic event. There is currently two types of secondary~     prevention :~        -  Mitchell’s debriefing based upon stress and its theories, using cognitive and~          behavioural approaches~        -  French debriefing (post-immediate psychotherapeutic intervention) based on the~          traumatism, never realised before second day post event and applied by mental health~          professionals.~      The current controversy of the Mitchell’s debriefing leads us to evaluate the post-immediate~     psychotherapeutic intervention, never evaluated yet.~      Scientific Objectives Primary objective: To verify that post-immediate psychotherapeutic~     interventions (proposed after 2 days and before the end of first month post event) decrease~     incidence, duration and intensity of psychotraumatic disorders at one year, versus a control~     group.~      Secondary objectives :~        -  To document the efficacy of these interventions regarding professional, social and~          familial adaptation.~        -  To identify predictive factors of response to this strategy.~      Method Experimental Design National multicentered, randomized, single blind study Study~     Population 330 men or women aged 18 to 65, subjected to a potentially traumatic event~     (criteria A1, DSM IV) and having presented an emotional reaction (intense fear, impotency or~     horror, criteria A2, DSM IV). This event must have happened within 8 days prior~     randomization. Patients treated with βblockers and patients suffering from psychopathologic~     disorders won’t be considered for the study.~      Outcome measures Primary outcome: PTSD frequency (on the basis of questionnaire CAPS).~      Secondary outcome:~        -  Complete and subsyndormic PTSD occurence (CAPS),~        -  Intensity of psychotraumatic disorders (Sheehan scale),~        -  Psychopathologic disorder frequency (CIDI SF),~        -  Evolution of anxiety/depression (HAD scale),~        -  Alcoholization frequency (CAGE scale),~        -  Frequency of somatic adverse events,~        -  Access to health care (number and types of contacts).~      Expected benefits The post-immediate psychotherapeutic intervention shall avoid psychological~     disorders apparition or improve its symptoms. This would decrease consequences on personal~     life (social, relational and professional).~      The study results will allow a better knowledge of these post traumatic disorders.~   "
236833|NCT00455377|"~     The aim of the study is to examine inflammation in the airways and in peripheral blood, in~     workers in a cement plant i Norway.~   "
236834|NCT00455364|"~     The purpose of this study is to compare the safety and efficacy of Voriconazole with~     Itraconazole following lung transplantation.~   "
236835|NCT00455351|"~     Phase I study. Side-effects when combined with standard palliative radiotherapy.~   "
236836|NCT00455338|"~     The primary objective is to determine if meals of different fat and fiber content affect~     postprandial plasma testosterone concentration in women with polycystic ovary syndrome. Our~     hypothesis is that a high-fiber meal will have a greater reduction in testosterone~     composition compared with a high-fat meal.~   "
236837|NCT00455325|"~     Metabolic syndrome consists of a group of co-occuring conditions that increase an~     individual's risk of developing heart disease, stroke, and diabetes. The purpose of this~     study is to evaluate the short-term effectiveness of chloroquine, a protein-activation~     medication, at improving metabolic syndrome.~   "
236838|NCT00455312|"~     Transplantation with stem cells is a standard therapy in many centers around the world.~     Previous experience with stem cell transplantation therapy for leukemias, lymphomas, other~     cancers, aplastic anemia and other non-malignant diseases, has led to prolonged disease-free~     survival or cure for some patients. However, the high doses of pre-transplant radiation and~     chemotherapy drugs used, and the type of drugs used, often cause many side effects that are~     intolerable for some patients. Slow recovery of blood counts is a frequent complication of~     high dose pre-transplant regimens, resulting in a longer period of risk for bleeding and~     infection plus a longer time in the hospital.~      Recent studies have shown that using lower doses of radiation and chemotherapy (ones that do~     not completely kill all of the patient's bone marrow cells) before blood or bone marrow~     transplant, may be a better treatment for high risk patients, such as those with Dyskeratosis~     Congenita (DC) or Severe Aplastic Anemia(SAA). These low dose transplants may result in~     shorter periods of low blood counts, and blood counts that do not go as low as with~     traditional pre-transplant radiation and chemotherapy. Furthermore, in patients with~     Dyskeratosis Congenita or SAA, the stem cell transplant will replace the blood forming cells~     with healthy cells.~      It has recently been shown that healthy marrow can take and grow after transplantation which~     uses doses of chemotherapy and radiation that are much lower than that given to patients with~     leukemia. While high doses of chemotherapy and radiation may be necessary to get rid of~     leukemia, this may not be important to patients with Dyskeratosis Congenita or SAA. The~     purpose of this research is to see if this lower dose chemotherapy and radiation regimen~     followed by transplant is a safe and effective treatment for patients with Dyskeratosis~     Congenita or SAA.~   "
236839|NCT00455299|"~     The study aims to prove differences or equalities in outcome for patients operated with~     laparoscopic ventral hernia repair with different methods of fixation of mesh and with or~     without approximation of defect prior to meshfixation.~   "
236840|NCT00455286|"~     In this study we will test the hypothesis that concurrent chemoradiation (CCRT) with~     temozolomide after induction chemotherapy by conventional high-dose methotrexate (HD-MTX)~     plus dexamethasone may be an effective and well tolerated treatment for immunocompetent~     patients with PCSNL. Corticosteroid can effectively reduce brain edema and corticosteroid~     alone has resulted in complete or partial remission in about 40% patients with PCNSL. To~     enhance local disease control, CCRT with temozolomide will be used in the study. Temozolomide~     is a well-tolerated oral alkylating agent that is able to permeate the BBB. Concurrent~     temozolomide with WBRT has shown superior effect to WBRT alone for the treatment of~     metastatic brain tumors and glioblastoma multiforme. In addition, temozolomide has~     single-agent activity for PCNSL (21% CR in relapsed or refractory PCNSL in a phase II trial).~      This is an open-label, non-randomized, multi-center phase II study. The primary end point of~     is the complete response rate. This study is a two-stage design for testing non-inferiority~     of the proposed treatment as compared to the approximately 80% response rate reported for~     conventional treatment. Assuming a non-inferiority margin of 20%, a sample size of 25~     subjects, which provides an 80% power for establishment of non-inferiority. At the first~     stage, 15 subjects are to be enrolled. If equal to or more than 6 patients achieve complete~     response, the study would accrue additional 10 subjects. The treatment regimen is as follows.~      Induction chemotherapy: MS regimen (repeated every 14 days, total 4 cycles)~        -  Methotrexate 3.5 g/m2 i.v. infusion 4 hours on day1~        -  Methylprednisolone 200 mg/m2/day i.v. infusion 30 minutes, on day1-4 Concurrent~          chemoradiotherapy (CCRT)~        -  Whole brain radiation therapy (WBRT) 2 Gy per fraction daily, 5 days per week~          Temozolomide 75 mg/m2/day orally daily, only on the days of WBRT~   "
236841|NCT00455273|"~     The project outline which follows is a pilot investigation aimed at improving MRI parameters~     in DCE-MRI to optimize the detection of treatment responses in LABC.~      The primary objective is to define the activity of neoadjuvant chemotherapy in patients with~     biopsy proven operable breast cancer. Secondary objectives include evaluating a new MRI pulse~     sequence to optimize DCE-MRI of LABC responses.~   "
236842|NCT00455260|"~     This study aims to examine the safety, tolerability and pharmacokinetics of transdermal~     delivery of human Growth Hormone (hGH or somatropin) using the ViaDerm device in adult~     patients with Growth Hormone Deficiency Syndrome.~   "
236843|NCT00455247|"~     Anti-cancer treatment is often inducing side-effects that can affect the compliance to the~     treatment protocol and quality of life of the patients. The researchers will study if the~     nutritional intervention with the product could abrogate the undesired effects in a~     preventive manner.~   "
236844|NCT00455234|"~     Three hundred consecutive adult patients presenting to the emergency services of the~     department of psychiatry and who are diagnosed by the treating doctor to be needing~     tranquillization to control agitated or aggressive behavior will be randomized to receive~     either Injection Olanzepine I.M. or Injection Haloperidol 10mg + Injection Promethazine 50 mg~     in this parallel group, block randomized, centrally-randomzed, allocation-concealed,~     assessor-blinded pragmatic clinical trial.~      The main outcome measure that the two treatments would be compared on would be the clinical~     state of the patient 4 hours after intervention, but the rate of tranquillization, degree of~     sedation, proportions tranquil and / or asleep at 15, 30, 60 and 240 minutes, need for~     additional medication, use of physical restraints, doctors called back, numbers absconding~     and adverse effects at each of these time points would also be compared. Compliance with oral~     medication and adverse effects at the end of 2 weeks would also be compared.~   "
236845|NCT00455221|"~     The primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against~     CML in patients under Imatinib treatment.~      We will also perform some laboratory tests suggesting biological response.~   "
236846|NCT00455208|"~     The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating~     rheumatoid arthritis and osteoarthritis.~   "
236847|NCT00455195|"~     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The objective of this extension study is to assess the long-term safety and~     efficacy of alglucosidase alfa treatment in patients with Late-Onset Pompe Disease who were~     previously treated under the placebo-controlled, double-blind study AGLU02704 (NCT00158600).~   "
236848|NCT00455182|"~     The purpose of this study is to determine whether patients treated with acupuncture~     post-operatively following knee or hip arthroplasty achieve better pain control as measured~     by the Visual Analog Scale and pain medication use.~   "
236849|NCT00455169|"~     Background. Influenza is increasingly recognized as causing severe respiratory illness in~     children. High-risk infants, like former premature infants, and particularly those with lung~     disease, have influenza hospitalization rates about five times higher than healthy children.~     Influenza vaccine does not protect young children against influenza as well as it does~     healthy adults. A small study that measured antibodies (proteins that protect against~     infection) to influenza suggested that premature infants get even less protection from~     influenza vaccine than full-term infants. More information about influenza vaccine in~     premature infants is needed. The overall goals of this project are to collect information~     about the how well the influenza vaccine induces antibody production, and to develop the~     collaborative network of centers necessary for a larger trial of influenza vaccine in~     premature infants.~      Objective and Hypotheses. The objective of this study is to measure the amount of protective~     antibody produced by influenza vaccine in premature (less than 30 weeks' [about 7 months]~     gestation at birth), extremely-low-birth-weight (1000 grams [2¼ pounds] or less at birth)~     infants. Influenza vaccine needs to be given yearly. We will assess premature infants during~     their first series of influenza vaccines. We hypothesize that the levels of antibody will be~     lower in premature infants receiving their first series of influenza vaccine than in~     full-term infants.~      Design. We will measure the immune response in premature and full term infants. During the~     2007-2008 influenza season, a total of 92 subjects, divided among 2 groups (premature infants~     6-17 months old receiving their first influenza vaccine series and full-term infants 6-17~     months old receiving their first influenza vaccine series) will be recruited at a consortium~     of five centers (the University of Rochester, the University of Texas Southwestern Medical~     Center, Wake Forest University, the University of Miami and the State University of New York~     at Buffalo), receive 2 doses of influenza vaccine, and have antibody and immune cell~     responses to each vaccine component measured 4-6 weeks after the second dose of vaccine.~      Potential Impact. If this study and future investigations suggested ways to improve premature~     infants influenza vaccine responses, they could lead to changes in recommendations for the~     number or timing of vaccine doses or of the type of vaccine used in this high-risk group.~   "
236850|NCT00455156|"~     The purpose of this study is to evaluate the one-year data on the contraceptive efficacy and~     safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new~     delivery system for contraception.~   "
236851|NCT00455143|"~     This is a pilot study to evaluate the effect of dexmedetomidine in the prevention of delirium~     in non-cardiac surgical patients. The preliminary data regarding the effect of~     dexmedetomidine on delirium comes from a study underway at Stanford. We propose to randomize~     fifty patients into two different protocols, one using dexmedetomidine until PACU discharge~     (hip replacement) and the other using dexmedetomidine for 24 hours in a monitored setting.~   "
236852|NCT00455130|"~     Cystic fibrosis is the most frequent lethal genetic disease of childhood. Causes disruption~     of glandular function of the pancreas, intestine, liver, lungs (causing chronic lung~     infection with emphysema), sweat glands and reproductive organs. We know that many CF~     patients die of lung failure, brought about in part by repeated lung infections caused by~     thick, sticky mucus that cannot be readily cleared from the lung.~      Inhaled mannitol is an osmotic agent that has been investigated in a number of small studies~     that have examined mucociliary clearance, quality of life and lung function in CF and~     bronchiectasis. The promising results of these studies warrant futher investigation. The aim~     of this study is to assess the safety and efficacy of inhaled mannitol when administered~     twice a day over two weeks in CF.~   "
236853|NCT00455117|"~     Aim of this trial:~      To investigate whether post-craniotomy analgesia with (i) intravenous (IV) parecoxib plus~     intravenous paracetamol is superior to (ii) intravenous paracetamol alone.~      Study Hypothesis:~      Post-operative analgesia with intravenous parecoxib in combination with intravenous~     paracetamol will be superior to intravenous paracetamol alone.~   "
236863|NCT00454987|"~     The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48~     months after the administration of a booster dose of Menitorix™, given at 12-15 months of~     age. The children had previously received 3 doses of Menitorix™ and Infanrix™ IPV or~     Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be~     investigated in children of 40-43 months of age who received a 3-dose primary vaccination of~     a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of~     MenC conjugate and Hib vaccine in the second year of life.~      This protocol posting deals with objectives & outcome measures of the extension phases at 12,~     24 and 48 months after the booster phase. The objectives & outcome measures of the primary~     phase & booster phase at 12 to 15 months are presented in a separate protocol posting (NCT~     number =00258700 ).~   "
236864|NCT00454974|"~     This is a pilot study of a wearable type of kidney dialysis machine to treat patients with~     chronic kidney disease.~   "
237088|NCT00451984|"~     The response to vaccination for hepatitis is reduced in patients with HIV infection. The~     hypothesis of the study is that adjuvant interleukin-2 administered subcutaneously at the~     time of vaccination improves the response rate.~   "
236854|NCT00455104|"~     CFDI NATIONAL REGISTRY~      Fabry disease is a rare, inherited, genetic condition due to a deficiency of an enzyme called~     alpha-galactosidase A. This enzyme deficiency causes the small blood vessels to accumulate a~     substance called glycolipid. Without sufficient levels of the enzyme, alpha-galactosidase A,~     persons with Fabry Disease develop severe neuropathic pain, kidney disease, heart disease,~     stroke and/or premature death; often before the age of 60.~      Fabry Disease is estimated to affect approximately one out of every 40,000 males and up to~     twice as many females in Canada. We do not have the exact number of persons in Canada who~     have this disease. A common problem in studying rare conditions is the difficulty in~     identifying the majority of people suffering from such a disease. Gathering their health~     information in order to better understand the natural disease progression and its response to~     treatment is difficult.~      Early ERT studies involving humans had small numbers of subjects and the studies were of~     short duration. The results of these clinical studies did lead to approval of the therapy in~     many countries around the world including Canada. To date though, evidence of the usefulness~     of ERT and its direct impact on the natural course of Fabry disease has been limited, while~     its cost continues to be very high. As a result of these issues, there will need to be~     continued and long-term collection of information related to the effectiveness of ERT and~     other treatments to better document its true clinical outcomes in Canadian people with Fabry~     disease.~      The Canadian Fabry Disease Initiative National Registry (CFDI-NR) is an observational,~     voluntary registry designed to collect outcomes data on Fabry disease from people living in~     Canada.~   "
236855|NCT00455091|"~     Research Objective and Study End Points To evaluate the anti-HBV as well as HCC recurrence~     reducing effects of standard (18 months) lamivudine treatment at time of HBV reactivation~     with hepatitis flare up (HBV DNA > 105 copies/mL and ALT level > 2.0 x UNL) or prophylactic,~     prolong (36 months) adefovir dipivoxil therapy in post-operative HBsAg(+),< 5 cm HCC~     patients, and to compare the results of who group with historical controls (T1297, HBsAg+,< 5~     cm HCC cohort),in terms of the following endpoints.~        1. Primary endpoint:~           the 3-years recurrence rate (excluding those recur within first year).~        2. Secondary endpoints:~      the first 2 year tumor recurrence rates the recurrence-free survival the overall survival.~     anti-viral efficacy, i.e. biochemical response and viral response rate. to correlate the~     changes of viral titer with the clinical outcome in post- operative HCC patients with~     adjuvant lamivudine or adefovir therapy.~   "
236856|NCT00455078|"~     Recent data has suggested that GER (gastric reflux) may worsen after lung transplantation and~     potentially increase the risk of chronic rejection (CR) after lung transplantation.~      The purpose of this study is to look at how often GER occurs in the lung transplant~     population and examine how GER may change the immune system and cause CR. In this way, we~     would be able to better identify patients that may benefit from anti-reflux procedures.~   "
236857|NCT00455065|"~     The purpose of this study is to determine if intake of whole grain foods as part of a~     hypocaloric diet enhances weight loss and improves cardiovascular disease risk factors in men~     and women with metabolic syndrome.~   "
236858|NCT00455052|"~     This amended expansion phase of the protocol is to further the experience at a dose level of~     150 mg CPT eq/m2 in patients with Stage IV non-small cell lung cancer (NSCLC) and small cell~     lung cancer (SCLC) and to test for preliminary anti-tumor activity in these tumor types. The~     MTD was initially defined as 113 mg CPT equivalents(eq)/m2 in the dose escalation part of the~     study. However, in the initial expansion phase (Protocol Amendment 11), 11 patients (10 NSCLC~     patients and 1 gastric cancer patients) were dosed at 113 mg CPT eq/m2 and less bone marrow~     toxicity was observed as compared to more heavily pre-treated patients in the dose escalation~     part of the study. Therefore, this amended expansion phase will investigate the safety and~     anti-tumor effects of a dose of 150 mg CPT eq/m2.~      The study will also determine:~        -  The safety and tolerability of XMT-1001 at 150 mg CPT eq/m2~        -  The pharmacokinetics (PK) of XMT-1001 (how XMT-1001 behaves in the body) in patients~          Stage IV non-small cell lung carcinoma (NSCLC) and small cell lung cancer~        -  Evidence of XMT-1001 anti-tumor activity at 150 mg CPT eq/m2~   "
236859|NCT00455039|"~     Neoadjuvant chemotherapy has become the standard of care for breast cancer patients with~     large tumors in order to render them operable for mastectomy or, in some cases, for~     lumpectomy and radiation therapy. Building on this theme, several large hormonal therapies~     are extensively investigated in the neoadjuvant setting, together with biologic correlates~     for response and resistance. As a further extension, neoadjuvant therapies with biologic~     agents are now too, being investigated for biologic evidence of efficacy before large-scale~     clinical trials of thousands of patients are embarked on. The neoadjuvant setting is~     especially attractive for these studies for several reasons including early assessment of~     response to therapy, biopsiable access to the primary tumor, and considerable reduced sample~     sizes compared to those required in the adjuvant setting. In addition, clinical response to~     neoadjuvant chemotherapy is a validated surrogate marker for improved survival. It may be~     used to test the overall efficacy of neoadjuvant treatment regimens and mirrors the effect of~     therapy on micrometastases setting. In a recent study, good clinical response to neoadjuvant~     chemotherapy was the only independent variable, by multivariate analysis, associated with~     decreased risk of death.~      GW572016 is a new and promising dual tyrosine kinase inhibitor against HER1/2. Hundreds of~     patients were treated in phase I and II studies world-wide and results indicate that this~     reversible, oral small molecule is generally well-tolerated. Studies of neoadjuvant~     Trastuzumab indicate that HER2 interference leads to significant tumor regression even after~     3 weeks of monotherapy. We aim to extend these findings with a novel agent, GW572016 that may~     be more effective, especially from its in vitro data, and to discover the true response rate~     to inhibiting HER1/2 signal transduction in breast cancer patients.~   "
236860|NCT00455026|"~     Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect~     of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our~     hypothesis is that this new method will more accurately predict depth of anaesthesia than the~     Bispectral Index (BIS) monitor in patients having elective surgery.~   "
236861|NCT00455013|"~     The purpose of this clinical research study is to learn if belatacept (BMS-224818) is~     expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based~     immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The~     long-term safety and tolerability of belatacept based regimens following long-term~     administration in subjects who have received a kidney transplant~   "
236862|NCT00455000|"~     The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and~     well tolerated in Adults with Mild to Moderate Alzheimer's disease.~   "
236881|NCT00454740|"~     To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have~     OAB syndrome (urgency, with or without urge incontinence, usually with frequency and~     nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin~     succinate due to lack of sufficient improvement in urgency episodes~   "
236865|NCT00454961|"~     The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine~     (Coartem®) treatment provided by community health workers against uncomplicated malaria in~     children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of~     42 days. The hypothesis is that artemether-lumefantrine treatment provided by community~     health workers will result in less than 85% PCR-corrected parasitological effectiveness by~     day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.~   "
236866|NCT00454948|"~     Obesity among Mexican-American women has the potential to become a public health crisis.~     Hispanics are one of the fastest growing minority populations in the United States and the~     prevalence of obesity in Mexican American woman is increasing at an alarming rate. Poor~     dietary practices, especially food habits that are acquired as families acculturate to the~     American food supply, and lack of exercise are thought to be associated with women's excess~     weight gain. Accordingly, interventions are needed to improve the dietary intake and physical~     activity levels of Mexican-American families.~      We propose to conduct a randomized clinical trial in which women are randomly assigned to~     receive either family-based behavioral counseling (FBC) sessions and play group physical~     activity sessions or group based nutrition and exercise classes and health related activity~     worksheets to complete with their child. The FBC sessions, conducted by community health~     advisors, will use photographs of the family's food practices, taken by mothers, as visual~     aids in the counseling sessions. The control intervention will consist of group sessions~     using curricula designed to motivate women to exercise and to promote the Food Guide Pyramid~     recommendations using traditional Mexican-American foods. The primary outcome of the trial is~     mother's BMI. The secondary outcomes are dietary intake, moderate to vigorous physical~     activity and household food supplies. We hypothesize that within a one year time frame, women~     who are exposed to the FBC will have lower BMI's compared to women who receive the active~     placebo control intervention. The mechanisms through which we intend to change weight status~     are altering the type of foods purchased and cooking practices and promoting mothers to~     engage in physical activities with their children during their play. Measurements of~     secondary outcomes include three 24 hour dietary recalls, a household food inventory and~     activity monitoring using MTI actigraph monitors. In addition, mothers' reports of household~     food security level, and food purchase motives, will be collected as covariates. Measurements~     will be collected within one month of completing the interventions and at six months and one~     year follow-up.~   "
236867|NCT00454935|"~     The purpose of this study is to investigate the correlation of SV2A expression in surgically~     removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with~     their clinical response to levetiracetam.~   "
236868|NCT00454922|"~     Glaucoma is a leading cause of blindness worldwide. Non-adherence to glaucoma medication,~     which may result in loss of vision, is known to be prevalent. Available information regarding~     adherence to prescribed medical therapy suggests that some apparent treatment failures may~     actually be due to non-adherence. The investigators' specific aim is to conduct a study that~     will examine the effect of a glaucoma educator intervention on adherence to topical glaucoma~     therapy. The investigators' hypothesis is that patient education and counseling delivered by~     a trained glaucoma educator, through both planned visits and telephone contacts, will~     increase adherence to topical glaucoma therapy.~   "
236869|NCT00454909|"~     The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK~     Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults~     11-25 years of age.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~      The protocol posting has been updated following a protocol amendment.~   "
236870|NCT00454896|"~     The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in~     patients with urgency who have overactive bladder syndrome.~   "
236871|NCT00454883|"~     Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective~     disorders.~   "
236872|NCT00454870|"~     The purpose of this study is to determine in an 8-week treatment study if MEM 3454 is a safe~     and effective treatment for patients with mild to moderate Alzheimer's disease.~   "
236873|NCT00454857|"~     This is a multi-center prospective observational descriptive study complemented by a~     retrospective chart review. Patients diagnosed with ITP and currently treated for ITP by a~     hematologist or hematologist-oncologist will be recruited from community-based clinics and~     academic/referral centers. They will be followed prospectively for a period of 12 months. At~     inception, participants' charts will also be reviewed from the date of enrollment~     retrospectively to the date of diagnosis or the previous 36 months, whichever is less.~   "
236874|NCT00454831|"~     Chitosan is a natural product that is produced commercially through the deacetylation of~     chitin, which is found in the exoskeleton of crustaceans. It has been suggested that chitosan~     has a lipid-lowering effect.~      This study was designed to determine if HEP-40 chitosan (Enzymatic Polychitosamine~     Hydrolysate - 40kDa), a short-chained chitosan with a molecular weight of 40 kDa, is safe and~     effective in lowering LDL-cholesterol levels in patients with mild to moderately elevated~     cholesterol levels and who have not been previously treated with other lipid-lowering agents.~   "
236875|NCT00454818|"~     The study is divided into 2 parts. In the first part, the safety of the gene transfer agent~     MYDICAR® will be evaluated. In the second part, the ability of MYDICAR® to improve heart~     function will be studied.~   "
236876|NCT00454805|"~     The purpose of this study is to determine whether AZD2171 can effectively improve time to~     tumour progression when added to fulvestrant in patients with advanced hormone sensitive~     breast cancer who progressed on prior hormonal therapy.~   "
236877|NCT00454792|"~     The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes~     from The Backcenter Funen, Ringe:~        1. To compare the effect of two types of non-operative treatments:~           A. exercise and advice to be physically active~           B. restitution and advice not to overload the spine~        2. To investigate if the results of the treatment are influenced by gender, age, smoking,~          and physical load.~   "
236878|NCT00454779|"~     This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation~     clinical trial of docetaxel and cisplatin combination chemotherapy with and without~     panitumumab in the first-line treatment of subjects with metastatic or recurrent head and~     neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail~     the chemotherapy only arm. This study will be conducted in the United States. Approximately~     150 subjects with histologically or cytologically confirmed metastatic and/or recurrent~     SCCHN.~   "
236879|NCT00454766|"~     Primary Objective:~      To pilot test high and low literacy patient education materials for colposcopy clinic~     patients, assessing impact on patient knowledge and patient feedback about the materials.~   "
236880|NCT00454753|"~     This protocol allows CML and Ph+ ALL subjects who are resistant to or intolerant of imatinib~     mesylate, to potentially benefit from dasatinib. It is intended to provide patients with~     access to dasatinib while awaiting reimbursement decision in Korea and it will also provide~     additional data on the safety of dasatinib in Korean population~   "
236882|NCT00454714|"~     This will be a prospective, phase IIIb, double-blind and randomized trial testing the effect~     of single dose sildenafil application in patients with coronary vasospasm compared to placebo~     application.~      The target variable to be tested is the degree of coronary vasoconstriction in response to~     intracoronary ACh application (in addition to clinical chest pain) which will be imaged by~     coronary angiography and measured using quantitative coronary angiography software.~      Main objective: Has sildenafil the potency to inhibit the induction of coronary vasospasm by~     intracoronary ACh-application in patients with proven coronary artery spasm?~      Secondary objective: Which degree of coronary vasospasm inhibition can be achieved with~     sildenafil?~   "
236883|NCT00454701|"~     Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months~     to gather general health information.~   "
236884|NCT00454688|"~     The purpose of this study is to evaluate the safety and efficacy of different doses of~     asimadoline in the treatment of patients with irritable bowel syndrome.~   "
236885|NCT00454675|"~     To determine whether an average population of males and females who smoke 10 pack years or~     more of cigarettes in a primary care setting with chronic bronchitis has already developed~     significant changes on pulmonary function testing.~   "
236886|NCT00454662|"~     The purpose of this study is to investigate which combination therapy is more effective in~     reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive~     patients: AT1 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1~     subtype angiotensin II receptor antagonist/low dose diuretic.~   "
236887|NCT00454649|"~     To determine the best dose of this investigational agent AG-013736 in combination with~     various standard of care treatments for advanced solid tumors.~   "
236888|NCT00454636|"~     This study will assess the safety and efficacy of Xeloda, given in combination with standard~     chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric~     cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy~     regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the~     chemotherapy regimen used. The anticipated time on study treatment is until disease~     progression, and the target sample size is 100-500 individuals.~   "
236889|NCT00454623|"~     The purpose of the study is to establish the normal levels of the hormone adiponectin in~     women. Adiponectin is a newly discovered hormone, which is said to be associated with many~     changes in the human body and metabolism. The researchers aim is to establish the normal~     levels of this hormone. Hence, the researchers can identify people with abnormal levels who~     may be at risk of diseases and can do more studies to help them.~   "
236890|NCT00454610|"~     The purpose of the study was to design a weight management program for Mexican American youth~     and to determine the effectiveness of the program for weight management compared to a self~     help program.~        1. At the end of 6 months, individuals randomly assigned to Intensive Intervention (II)~          (instructor/trainer led intervention) will lose more weight than individuals assigned to~          Self Help (SH) only.~        2. At the end of 1 year, individuals randomly assigned to II will maintain their weight~          losses better than individuals assigned to SH.~      Secondary hypotheses will include examination of main effects and interactions at the end of~     6 months with the following secondary dependent measures: treatment adherence (e.g.,~     attendance, food diaries, exercise diaries), blood levels, changes in percent body fat,~     overall psychological functioning (PEDS-QL 4.0), and eating behaviors as assessed by food~     frequency checklists.~   "
236891|NCT00454597|"~     To determine if the omentectomy diminishes hyperglycemia and improves the resistance to the~     insulin in patients with morbid obesity and propensity to develop to Diabetes Mellitus type~     2.~   "
236892|NCT00454584|"~     The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in~     patients with moderate to severe plaque psoriasis.~   "
236893|NCT00454571|"~     This randomized phase II trial is studying how well pazopanib hydrochloride works after~     leuprolide or goserelin in treating patients with relapsed prostate cancer. Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of~     prostate cancer cells. Antihormone therapy, such as leuprolide acetate or goserelin acetate,~     may lessen the amount of androgens made by the body. Giving pazopanib after leuprolide or~     goserelin may be an effective treatment for prostate cancer~   "
236894|NCT00454558|"~     This is a study to demonstrate the feasibility of an individual dose titration scheme based~     on the systolic blood pressure with a dose range from 1.0 mg TID to 2.5 mg TID. Patients~     suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial~     hypertension (PAH) will be included. After diagnosis by an expert center, patients receive~     medication three times a day starting with 1.0 mg TID. The first tablets are given in the~     hospital, then the patients are allowed to go home and take the medication at home. After 2~     weeks, patients return to the hospital for an ambulatory visit and the dose may be increased~     based on the actual condition of the patient (blood pressure and adverse events). Several~     measurements will be performed to test the efficacy of the drug and whether there are any~     unwanted reactions to the drug (blood tests, ECG, 6 minute walk test, imaging by Echo,~     quality of life scores). The dose of the drug will then be increased further until unwanted~     effects may occur or the blood pressure drops to low. The highest dose tested will be 2.5 mg~     TID. After 12 weeks the patient is going to stay in the hospital again and a right heart~     catheter is performed to examine the changes in hemodynamics after 12 weeks of treatment with~     the drug. If the patients give their consent they can enter a long-term extension trial~     continuing on BAY63-2521 with the dose reached after 12 weeks. Every 3 months an ambulatory~     visit at the specialist center will be performed including measurements of safety (blood~     tests, ECG, clinical assessment) and efficacy (6 minute walk test, Borg dyspnea scale, NT-pro~     BNP). Blood tests and ECG have been removed begin of 2013 as safety parameter by amendment 7;~     furthermore Borg dyspnea score and NT-proBNP have been removed as efficacy parameter.~      Initially the inclusion of ten patients suffering from chronic thromboembolic pulmonary~     hypertension (CTEPH) or pulmonary arterial hypertension (PAH) was planned. Later on the~     patient number was amended and 75 patients entered the trial.~      Furthermore the trial duration was extended and a long term treatment with BAY63-2521 was~     offered to the patients. Finally 68 patients moved over to the long term extension period of~     the trial.~   "
236895|NCT00454545|"~     Open pilot study to collect information regarding the effect of atorvastatin on patients with~     active Crohns disease.~   "
236896|NCT00454532|"~     BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family.~     Preclinical studies suggest that this herb has antitumor activity for breast cancer and~     preliminary clinical data suggest that it is tolerable in patients with metastatic breast~     cancer. The overall goals of this Phase I/II trial are to assess the toxicity, maximum~     tolerated dose, safety and preliminary efficacy of BZL101 for the treatment of advanced~     metastatic breast cancer.~   "
237293|NCT00449254|"~     Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of~     fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese~     subjects.~   "
236897|NCT00454519|"~     OBJECTIVES:~        -  Determine response and survival of patients with peritoneal carcinomatosis treated with~          cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with~          cisplatin and mitomycin~        -  Assess the quality of life of patients treated with this regimen.~      OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the~     patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion~     with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent~     routine cytoreductive surgery.~      All patients in both groups receive the standard conventional chemotherapy after surgery.~      Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at~     4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.~   "
236898|NCT00454506|"~     Total joint replacements are some of the most successful medical devices developed over the~     last fifty years. They enable millions of people to remain ambulatory and pain free, with~     minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements,~     and 25,000 total or partial shoulder replacements were performed in the United States (HCUP~     data). Future use will likely be even higher: it is estimated that by the year 2020, the~     population 65 and over in developed countries will increase by 71%. Existing studies do not~     provide adequate prospective data to evaluate long-term outcomes. Most health related quality~     of life studies in THA and TKA only report data up to twelve months post-operatively. In~     addition, most large studies of TKA and THA have been performed in Medicare patients. While~     these databases are important in providing population based data, Medicare studies do not~     permit any direct patient contact, and provide no information on patients under 65.~      Existing studies have also investigated predictors of patient outcome at one and two years~     after joint arthroplasty. However, very little is known about predictors of prosthesis~     failure, and there are no validated clinical indicators for choosing one prosthesis model~     over another. Once a device is FDA approved, there is very little motivation on the part of~     the developer to perform complete post-marketing research, despite the importance of these~     data to the public health. Most existent studies are not powered to compare differences~     between models.~      The purpose of this study is to establish a prospective cohort of HSS total hip arthroplasty.~   "
236899|NCT00454493|"~     The purpose of this study is to investigate whether there is a difference in endothelial~     function, heart rate variability and carotid intimal media thickness in patients with~     coronary artery disease who are receiving fish oil therapy.~      One hundred patients with established coronary artery disease by coronary angiography will~     undergo randomization for enrollment in the study. Baseline evaluation will include~     assessment of brachial artery endothelial function, heart rate variability and carotid~     intimal media thickness. Evaluation of the endothelial function of the brachial artery will~     be elucidated by inflation of a blood pressure cuff around the arm for five minutes and~     measuring blood vessel dynamics after release of the cuff. Heart rate variability will be~     evaluated by 24 hour holter monitoring and analysis by standard protocol. Carotid intimal~     media thickness will be evaluated by ultrasound measurements guided by predetermined~     protocol. Patients will then be randomized to a highly purified fish oil, Omacor, 1 gram~     twice a day or placebo. Brachial artery ultrasound and holter monitoring will be repeated at~     2 months. Carotid ultrasound will be repeated at the end of the study at 12 months.~   "
236900|NCT00454480|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     carry cancer-killing substances to them. Tipifarnib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together~     with gemtuzumab ozogamicin or tipifarnib may kill more cancer cells.~      PURPOSE: This randomized phase II/III trial is studying different combination chemotherapy~     regimens to compare how well they work when given with or without gemtuzumab ozogamicin or~     tipifarnib in treating patients with acute myeloid leukemia or high-risk myelodysplastic~     syndromes.~   "
236901|NCT00454467|"~     Total joint replacements are some of the most successful medical devices developed over the~     last fifty years. They enable millions of people to remain ambulatory and pain free, with~     minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements,~     and 25,000 total or partial shoulder replacements were performed in the United States (HCUP~     data). Future use will likely be even higher: it is estimated that by the year 2020, the~     population 65 and over in developed countries will increase by 71%. Existing studies do not~     provide adequate prospective data to evaluate long-term outcomes. Most health related quality~     of life studies in THA and TKA only report data up to twelve months post-operatively. In~     addition, most large studies of TKA and THA have been performed in Medicare patients. While~     these databases are important in providing population based data, Medicare studies do not~     permit any direct patient contact, and provide no information on patients under 65.~      Existing studies have also investigated predictors of patient outcome at one and two years~     after joint arthroplasty. However, very little is known about predictors of prosthesis~     failure, and there are no validated clinical indicators for choosing one prosthesis model~     over another. Once a device is FDA approved, there is very little motivation on the part of~     the developer to perform complete post-marketing research, despite the importance of these~     data to the public health. Most existent studies are not powered to compare differences~     between models.~      The purpose of this study is to establish a prospective cohort of HSS total knee~     arthroplasty.~   "
236902|NCT00454454|"~     The purpose of this research study is to compare a virtual reality display device with the~     standard neuropsychological evaluation for detecting mild cognitive impairment (problems with~     memory, concentration, reaction time, etc.).~   "
236915|NCT00454285|"~     The major purposes of this prospective, randomized, clinical study are to:~        1. Determine and compare the true incidence, nature, magnitude, and duration (INMD) of~          bacteremia (bacteria found in the bloodstream) resulting from a highly invasive dental~          office procedure (tooth extraction) and a minimally invasive and naturally occurring~          source of bacteremia (tooth brushing);~        2. Measure the effect of the American Heart Association's guidelines for amoxicillin~          prophylaxis (preventive treatment) on the INMD of bacteremia resulting from a single~          tooth extraction.~   "
236903|NCT00454441|"~     Menopausal women often complain of difficulty sleeping and the transition from pre- to~     postmenopausal status is associated with an incresase in self-reported sleep disturbance. Hot~     flashes have been associated with self-reported measures of sleep disturbance and changes in~     sleep pattern as measured by plysomnography, including an increase in stage 4 and a latency~     or shortened time in rapid-eye movement sleep. Although there are some data on the effect of~     hormone replacement therapy on self-reported sleep measures in symptomatic postmenopausal~     women, there are no data on the effect of herbal extracts on subjective or objective measures~     of sleep quality in this population group. Actigraphy, the use of a device to record movement~     generally placed on the wrist, has been used over 20 years to provide objective data~     concerning sleep/wake patterns. The advantage of actigraphy over traditional polysomnography~     is that actigraphy can conveniently record continuously for 24-hours a day for longer periods~     of time.~   "
236904|NCT00454428|"~     Linear flow during cardiopulmonary bypass (CPB) frequently induces renal damage.~      We will evaluate whether automatic intra-aortic balloon pump (IABP) induce pulsatile~     perfusion preserves renal function in patients undergoing myocardial revascularization at~     different risk for renal damage.~      100 patients undergoing preoperative IABP will be stratified for renal function.~      Intervention. The patients will be randomized to non-pulsatile CPB during cardioplegic arrest~     or automatic IABP induced pulsatile CPB.~      Renal function, daily diuretics, complication rate, lactatemia and other biochemical indices~     will be compared in patients.~      We will prospectively enrolle 100 patients undergoing isolated primary high-risk coronary~     artery bypass grafting for severe left main stem disease (70% narrowing) or left-main~     equivalent three-vessels coronary disease. On admission to our institution, the patients will~     be stratified for renal function according to KDOQI and randomly assigned to Group A or Group~     B. We will exclude from the study patients older than 75 years, and/or with kidney disease ≥~     Stage 4 (GFR 15 – 29 ml/min/1.73 m2), and/or with other splanchnic organ comorbidities (liver~     or mesenteric impairment, abdominal aortic aneurysm, abdominal arteries vasculopathy), and/or~     severe autoimmune disease.~      The patients randomized to Group A (n=50) will receive a preoperative IABP treatment before~     induction of anesthesia, with IABP turned off during cardioplegic arrest, and restarted with~     a 1:1 IABP mode immediately after cross-clamp removal (as is the traditionally adopted~     perioperative IABP support); the other 50 (Group B) will receive standard preoperative~     treatment with IABP, which will switche into an automatic 80 bpm mode during cross-clamp~     time, and switche again into a 1:1 IABP after cross-clamp removal, in order to achieve a~     pulsatile perfusion during the entire intra-operative time-course.~      The patients will be stratified in 2 subgroups according to the preoperative renal function:~     a subgroup will include 64 patients (32 allocated in Group A and 32 in Group B) with stage 1~     or 2 [Stage 1: GFR ≥90 ml/min/1.73 m2 – Stage 2: GFR 60 - 89 ml/min/1.73 m2] and therefore~     considered at lower-risk for post-CPB renal damage; the remaining 36 (18 for each group) with~     KDOQI Stage 3 of kidney disease (GFR 30 – 59 ml/min/1.73 m2) will be considered at~     higher-risk for perioperative renal complications [19].~   "
236905|NCT00454415|"~     Asthma is a common illness among children in the United States. While there are many known~     causes of asthma, including tobacco smoke, pollen, dust, or other allergens, the exact cause~     of asthma in some individuals remains unknown. This study will examine the role that specific~     dietary factors and body mass index (BMI) play in the development of childhood asthma.~   "
236906|NCT00454402|"~     The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days,~     on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave~     Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any~     stone after 72h to 96 hours.~      This study will also specifically focus on the evaluation of time of stone clearance and of~     pain reduction (Numeric Rating Scale).~   "
236907|NCT00454389|"~     The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery~     of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated~     with wet age-related macular degeneration (AMD). The Epi-Rad90™ Ophthalmic System treats~     neovascularization of retinal tissue by means of a focal, directional delivery of radiation~     to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the~     sealed radiation source is placed temporarily over the retinal lesion by means of a handheld~     medical device.~   "
236908|NCT00454376|"~     RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects~     of treatment and improve the ability to plan treatment for patients with~     gastrointestinal-related neuroendocrine tumors.~      PURPOSE: This phase IV clinical trial is studying how well a disease-specific questionnaire~     works in assessing the quality of life of patients with gastrointestinal-related~     neuroendocrine tumors.~   "
236909|NCT00454363|"~     This phase II trial studies how well pazopanib hydrochloride works in treating patients with~     advanced neuroendocrine cancer. Pazopanib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
236910|NCT00454350|"~     This study will measure serum levels of the active Vitamin D compound that circulates in~     hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar®~     (paricalcitol injection).~   "
236911|NCT00454337|"~     Switching from enfuvirtide to raltegravir in the treatment of HIV-infected patients who~     sustain viral suppression with a combination therapy including enfuvirtide (or : with an~     enfuvirtide-based combination therapy)~   "
236912|NCT00454324|"~     This is a phase II trial of abraxane and carboplatin in extensive stage small cell lung~     cancer to examine overall response rate, time to progressive disease, survival time, and~     assessment of toxicity profile for Carboplatin and Abraxane.~   "
236913|NCT00454311|"~     The aim of this study is to evaluate the impact of the biopsy of one or two cells in a~     preimplantatation genetic diagnosis program (PGD) for the screening of aneuploidies. This~     prospective and randomized study will be performed at the Instituto Valenciano de~     Infertilidad in Valencia (Spain) in those patientes included in our clinical program. Our~     purpose is to optimize the methodology employed in our laboratory in order to guarantee~     optimal implantation and pregnancy rates without a detrimental effect on the accuracy and~     efficiency of the cytogenetic analysis. Patients will undergo and IVF cycle, embryo biopsy~     will be performed on day 3 embryos in two fashions: in some patients only one cell per embryo~     will be retrieved whereas in others, 2 cells will be retrieved in good morphology embryos and~     only 1 in the slowl ones. In all cases aneuploidy screening will be performed by FISH for~     chromosomes 13, 16, 18, 21, 22, X and Y. Embryo developmente will be checked every 24 hours~     and chormosomally normal embryos will be replaced into the uterus on day 5 of development.~   "
236914|NCT00454298|"~     The main purpose of the study is to find out if, after 4 weeks of dosing, signs of the~     investigational drug AGG-523, or its effects, can be measured in urine, blood, or the knee~     joint. A secondary purpose is to evaluate the safety of taking the drug either once a day or~     twice a day for 4 weeks.~   "
236916|NCT00454272|"~     The aim of the study is to evaluate the efficacy and safety of Teicoplanin versus Vancomycin~     as part of the initial antibiotic regimen in the therapy of patients with fever and~     neutropenia .~   "
236917|NCT00454259|"~     Exaggerated pain and hyperalgesia are major issues after surgery and can lead to chronic~     pain. Opioid are parts of pain sensitization processes but remain absolutely necessary in the~     intraoperative period. NMDA receptor antagonists succeed in reducing this pain sensitization~     process. Recent studies show that in pain and opioid-experienced rats (POER) fentanyl ultra~     low doses do not induce analgesia, as observed in naive rats, but hyperalgesia. This is the~     first demonstration that a drug can induce opposite effect depending on individual history.~     We also observed a strong correlation between this hyperalgesic response in POER and the~     intensity of hyperalgesia they develop later, after inflammatory or surgical pain. The main~     aim of this study is to measure the dose effect response to fentanyl ultra low doses on~     human volunteer's nociceptive threshold, to determine if such an opposite response profile~     can be revealed.~   "
236918|NCT00454246|"~     This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta~     (Mircera) in the maintenance of hemoglobin levels in patients who have previously received~     treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic~     kidney disease stage 4 through dialysis. Patients will be randomized either to receive~     Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc)~     Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or~     darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation~     of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a~     starting dose based on their previous (sc) dose, and those in the control group will receive~     weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the~     target sample size is 500+ individuals.~   "
236919|NCT00454233|"~     The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus~     patients and to investigate whether this study drug is effective in these patients~   "
236920|NCT00454220|"~     The purpose of this study is to determine the safety and effectiveness of 2 different doses~     of modified-release recombinant human thyroid stimulating hormone (MRrhTSH) when administered~     with radioiodine in patients with multinodular goiter, a condition that involves the~     enlargement of the thyroid gland. We will also evaluate the safety and effectiveness of~     radioiodine therapy alone in these patients. The goal of the treatment is to determine if~     there was a reduction in the size of the goiter and to study if goiter symptoms have improved~     after 6 months and after 36 months.~   "
236921|NCT00454207|"~     To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial~     hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of~     sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part~     1)~   "
236922|NCT00454194|"~     RATIONALE: Pemetrexed disodium and sorafenib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells~     by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib may~     kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying pemetrexed disodium and sorafenib to see~     how well they work compared with pemetrexed disodium alone as second-line therapy in treating~     patients with stage IIIB or stage IV non-small cell lung cancer.~   "
236923|NCT00454181|"~     This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a~     treatment of oral warts in HIV-positive adults.~      The hypothesis of this study is that interferon-alpha will be safe and that a higher~     percentage of subjects given interferon-alpha will experience a complete or nearly complete~     remission of their oral warts compared to subjects given placebo.~   "
236924|NCT00454168|"~     RATIONALE: Vaccines made from a peptide may help the body build an effective immune response~     to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of~     white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine~     therapy together with GM-CSF may be an effective treatment for acute myeloid leukemia. It is~     not yet known whether giving vaccine therapy together with GM-CSF is more effective than~     giving placebo together with GM-CSF in treating acute myeloid leukemia.~      PURPOSE: This randomized phase III trial is studying vaccine therapy and GM-CSF to see how~     well they work compared with a placebo and GM-CSF in treating patients with acute myeloid~     leukemia in remission.~   "
236925|NCT00454155|"~     The objectives of this study are as follows:~      To demonstrate the safety of escalating doses of opebacan in subjects undergoing~     myeloablative allogeneic Hematopoietic Stem Cell Transplantation~      To determine the pharmacokinetics of opebacan in subjects undergoing myeloablative allogeneic~     Hematopoietic Stem Cell Transplantation~      To determine if IV administration of opebacan is associated with changes in biological~     markers for inflammation~      To develop preliminary descriptive data on the occurrence and severity of Hematopoietic Stem~     Cell Transplantation related complications, including aGvHD~   "
236926|NCT00454142|"~     This phase II trial studies the side effects and how well pazopanib hydrochloride works in~     treating patients with stage IV or recurrent nasopharyngeal cancer. Pazopanib hydrochloride~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and~     by blocking blood flow to the tumor.~   "
236927|NCT00454129|"~     In patients with biliodigestive anastomosis direct cholangiography (ERC) is due to changed~     anatomy commonly not possible. The aim of the study is to test the feasibility to perform~     direct cholangiography in these patients via double-balloon enteroscopy and to compare it to~     MR cholangiography.~   "
236928|NCT00454116|"~     The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™~     (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer~     in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing~     regimen.~   "
236944|NCT00453908|"~     The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin~     compared to placebo, will increase the number of patients with satisfying spontaneous voiding~     after acute urinary retention treated with Clean Self-Catheterization.~      Furthermore is investigated the safety of the medical treatment and self-catheterization.~   "
237015|NCT00452972|"~     This study was undertaken to compare the two techniques (exteriorized vs in situ) of uterine~     repair with respect to patient comfort, hemodynamic changes, surgical time and blood loss, in~     patients undergoing elective CD under a strictly standardized spinal anesthetic. We~     hypothesized that in situ uterine repair would be more comfortable for the patients.~   "
236929|NCT00454103|"~     The improvement of conventional imaging techniques has led to an increased detection rate of~     different adrenal tumors. Since those tumors can belong to a variety of entities the~     therapeutic consequences also show considerable variation. In order to definitely determine~     the type of tumor, invasive procedures like CT guided biopsies are often required, which~     could be avoided by a tumor specific imaging method. The presently available scintigraphic~     procedures are either time consuming and lead to high radiation exposure or are technically~     demanding. The steroidogenic enzymes CYP11B1 (11ß-hydroxylase)and CYP11B2 (aldosterone~     synthase)are expressed exclusively in the adrenal cortex and therefore represent suitable~     targets for a specific imaging technique. In our project we evaluate 123I-Iodometomidate~     which binds to both CYP11B enzymes as radiotracer for adrenal scintigraphy.~   "
236930|NCT00454090|"~     The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330~     (ARRY-424704) in patients with Advanced Malignancies~   "
236931|NCT00454077|"~     Most patients with differentiated thyroid carcinoma (DTC) are treated with therapeutic doses~     of radioiodine (131I) after initial surgery (total or near total thyroidectomy), aimed to~     destroy microscopic residual normal or tumoral thyroid cells and to facilitate the early~     detection of tumor recurrence based on serum thyroglobulin (Tg) measurement and 131I whole~     body scan (WBS) (1-5). Recently, preparation of patients for thyroid ablation with rhTSH and~     3700 MBq of 131I on l-thyroxine (l-T4) therapy has been approved in Europe by the European~     Medicines Agency (EMEA) as an alternative to thyroid hormone withdrawal (6), after a~     randomized, controlled, multicenter study demonstrated that both methods of preparation are~     equally effective (with 100% rate of successful ablation) and that patients prepared with~     rhTSH received lower total body irradiation and experienced a better quality of life compared~     to those rendered hypothyroid (7).~      The present study was aimed to compare the efficacy of fixed activities of 1850 MBq versus~     3700 MBq of 131I for post surgical thyroid ablation in DTC patients prepared with rhTSH~     (TSHα, Thyrogen®, Genzyme Therapeutics, Cambridge, MA) on l-T4 therapy.~   "
236932|NCT00454064|"~     The purpose of the study:~        -  to compare two cognitive-behavioral treatments~   "
236933|NCT00454051|"~     The aim of this study is to evaluate the expression of IgE high affinity receptors (the part~     of the cell associated with allergic response) in patients suffering from uncontrolled severe~     asthma despite long term treatment with high dose of inhaled corticosteroid and long acting~     Beta-2 agonist.~   "
236934|NCT00454038|"~     The main purpose of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered~     bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring~     GBR.~   "
236935|NCT00454025|"~     Elevated intraocular pressure is widely accepted as a risk factor for glaucoma and~     controlling the pressure remains the cornerstone of effective treatment. There is evidence~     that posture can have a significant effect on intraocular pressure fluctuations. Salat (or~     Salah) refers to the five daily prayers performed by Muslims. The time spent praying in a~     kneeling or prostrate position may be associated with wide fluctuations in intraocular~     pressure, potentially sight-threatening for Muslim patients with glaucoma. The researchers~     seek to investigate the link between traditional daily Muslim prayer postural changes and~     intraocular pressure changes.~   "
236936|NCT00454012|"~     In this research project the investigators want to figure out whether ultrasound (a~     non-invasive method) can be used to assess how the fetus is doing during labor.~   "
236937|NCT00453999|"~     This study has been designed as a randomized, double-blind, controlled, study to evaluate the~     efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg)~     versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute~     serious or potentially life threatening influenza. Study treatments will be provided for up~     to 5 consecutive days.~   "
236938|NCT00453986|"~     The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of~     different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of~     GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of~     GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612~     given alone and the immunogenicity of GSK134612 given with Fluarix™.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
236939|NCT00453973|"~     The purpose of this study was to evaluate the long term safety and tolerability of~     peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease~     (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.~   "
236940|NCT00453960|"~     The aim of this study is to verify the anti-estrogenic activity of Genistein, on the non~     atypical endometrial hyperplasia, in premenopausal women.~   "
236941|NCT00453947|"~     This randomized controlled trial is primarily aimed at assessing the rate of acute myocardial~     infarction with the two noninvasive ventilatory techniques, non-invasive intermittent~     positive pressure ventilation and non-invasive continuous positive airway pressure.~   "
236942|NCT00453934|"~     The primary objective of this study is to compare patient preference of the h-Patch as~     delivery device for insulin lispro compared with either an insulin pen or needle and syringe~     in patients with diabetes, either Type 1 or Type 2, on stable multiple daily injection~     regimens. This will be assessed using an accepted preference scale.~   "
236943|NCT00453921|"~     Traumatic brain injury (TBI) is a significant public health problem, with 1.5-2.0 million~     Americans injured each year. Cognitive deficits, particularly in the domains of memory and~     attention are frequently the source of lingering disability after TBI and a source of~     enormous distress to the injured individuals and their family/caregivers. To date,~     interventions to ameliorate chronic cognitive deficits have been directed at either~     pharmacological interventions or cognitive rehabilitation. We propose to (1) To compare the~     efficacy of three interventions: memory and attention training (MAAT), methylphenidate, and~     memory/attention training in combination with methylphenidate and (2) use functional MRI~     (fMRI) to characterize changes in activation of the neural circuitry of memory and attention~     due to MAAT alone, methylphenidate alone, and MAAT in combination with methylphenidate. This~     is a two by two design with medication (methylphenidate/placebo) and cognitive therapy~     (Memory and Attention Training (MAAT) or an Attention control intervention) as possible~     interventions. Using a randomized, placebo-controlled, double-blind design, 200 individuals~     with persistent cognitive deficits 6-12 months after MTBI will be randomized to receive a six~     week trial of either (1) MAAT and placebo, (2) MAAT and methylphenidate (0.3 mg/kg BID), (3)~     attention control intervention and methylphenidate (0.3 mg/kg BID), or (4) attention control~     intervention and placebo. Symptom distress, attention and memory performance, and activation~     patterns of the neural circuitry of attention and memory while undergoing fMRI will be~     characterized at baseline, and after the four treatment conditions. This study will provide~     important information on three interventions for the most disabling sequelae of an enormous~     public health problem. Further, it will help to clarify underlying neural mechanisms and~     suggest additional treatment possibilities.~   "
236945|NCT00453895|"~     Although a first randomized trial in patients with advanced ACC leading to the establishment~     of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this~     FIRM-ACT study is most likely clearly above 50%. Therefore, the majority of participating~     patients urgently need a new treatment option. However, up to date there is no evidence for a~     single regimen that might be promising in these treatment-refractory patients with ACC.~      Sunitinib is an oral multitargeted tyrosine kinase inhibitor with anti-tumor and~     antiangiogenic activities, which is successfully tested in the treatment of patients with~     metastatic renal cell carcinoma, gastrointestinal stromal and neuroendocrine tumors after~     failure of standard cytotoxic chemotherapy.~      The primary objective of this trial is to estimate the response (defined as progression-free~     survival of ≥ 12 weeks) rate associated with Sunitinib treatment in patients advanced ACC~     progressing after cytotoxic chemotherapy.~   "
236946|NCT00453882|"~     The objective is to evaluate the feasibility of using color Doppler ultrasound in ureteral~     flow assessment after uterine artery occlusion during a conservative gynecological procedure.~   "
236947|NCT00453869|"~     The prevalence of chronic hepatopathies is high in jail. However, the medical care of these~     hepatopathies is few developed. This study is an observational, an epidemiologic (screening~     and prevalence of fibrosing hepatopathies) and an evaluating study for a better taking care~     of these hepatopathies in jail. The aims of the study will be to evaluate the diagnostic~     performance of the FibroMeter score in the screening of the hepatic fibrosis in persons with~     multiple risk factors for liver fibrosis (alcoholism, intravenous drug users, tattoo, and~     virological status) with FibroScan® as gold standard; to evaluate the feasibility of these~     different screening tools for chronic hepatopathies in jail and to evaluate the prevalence of~     the fibrosing hepatopathies with clinically significant fibrosis and theirs risk factors,~     alcohol and hepatitis B and hepatitis C viruses in population from Angers jail.~   "
236948|NCT00453856|"~     IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine~     vaccination visits, has been shown to significantly reduce malaria and anemia in two studies~     in Tanzania. However the results obtained in Gabon are not similar. Many factors are likely~     to influence the efficacy or effectiveness IPTi. It is reasonable to assume that the efficacy~     of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the~     antimalarial drug (Sulfadoxine-Pyrimethamine) used for IPTi.~      In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium,~     and to provide information for policy makers regarding the predicted efficacy of IPTi, it is~     essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine~     now that the IPTi trial has been conducted. The simplest and most universally accepted~     measure of testing for antimalarial drug efficacy is the in vivo efficacy study, which~     follows a standardized World Health Organization protocol.~      A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to~     determine if the intervention increases the carriage and/or spread of drug resistant P.~     falciparum parasites.~      Thirdly the overall effect at the community level of selection of resistant genotypes in~     IPTi-recipients is unclear.~   "
236949|NCT00453843|"~     We will test on persons with chronic impairment due to stroke:~        1. whether the order in which robot therapy is delivered influences outcomes~          (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).~        2. whether we should train the shoulder, elbow, and wrist at the same time or on different~          days.~   "
236950|NCT00453830|"~     Aim: This is a prospective, randomized comparison of traditional open (OS) and laparoscopic~     sigmoidectomy (LS) in patients with complicated diverticular disease. The study is designed~     in order to minimize bias by standardizing the two procedures and blinding patients and~     nurses during the preoperative and early postoperative period.~      Hypothesis: A laparoscopic approach for sigmoidectomy has significant advantages over the~     open technique with respect to postoperative pain, duration of ileus, length of hospital~     stay, and perioperative morbidity.~      Methods: Patients with complicated diverticular disease who are candidates for elective~     sigmoidectomy will be randomized the day before surgery, and anaesthetic technique and~     postoperative management will be standardized between groups. Surgeons with experience in~     both laparoscopic-assisted and open colectomy will perform both types of procedures. At the~     end of the operation, identical, opaque wound dressings will be applied and left in place~     until postoperative day 4. Both patients and nursing staff will therefore be blinded to the~     type of surgical technique during the early postoperative period.~      Endpoints:~      A) Postoperative pain assessed by the Visual Analog Scale at postoperative days 1, 2, and 3.~      B) Postoperative intake of systemic opiates (morphine)~      C) Duration of postoperative ileus, quantified by the interval in hours between the end of~     the procedure and passage of first stool.~      D) Duration of hospital stay.~      E) Surgical complications, such as wound infection, anastomotic leakage, bleeding~      F) General medical complications, such as cardiopulmonary, pneumonia, and renal failure.~      Rationale: This study will determine whether a laparoscopic sigmoidectomy is associated with~     significant clinical advantages over the traditional open approach when patients with~     complicated diverticular disease are blinded to the operative technique.~   "
236951|NCT00453817|"~     The primary objective of this pilot study is to assess the feasibility and safety of ex vivo~     islet labelling prior to intraportal transplantation in patients with type 1 diabetes with~     the purpose of islet graft imaging. The secondary objective is to determine the usefulness of~     this method for long-term islet graft monitoring.~   "
236952|NCT00453804|"~     The primary aim of this study is to determine the feasibility of long-acting injectable~     naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis~     of alcohol dependence. Secondary aims include providing a preliminary assessment of the~     tolerability and safety of long-acting injectable naltrexone as compared with oral naltrexone~     in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to~     provide a preliminary assessment of the efficacy of long-acting injectable naltrexone as~     compared with oral naltrexone in reducing alcohol use from baseline levels~   "
236953|NCT00453791|"~     This study will be the First Time in Human Study (FTIH) aiming to assess the safety and~     tolerability of GW805858 for both single and repeat dose. The study also aims to assess~     safety and tolerability in mild asthmatic subjects as well as healthy volunteers.~   "
236954|NCT00453778|"~     Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced~     bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where~     patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments.~     Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of~     each treatment period and on treatment days 13 and 14 respectively.~   "
236955|NCT00453765|"~     The purpose is to determine whether montelukast during 6 weeks has superior antitussive~     effects (measured with the LCQ) compared with placebo in patients with cough lasting > 8~     weeks and enhanced bronchial hyperreactivity.~   "
236956|NCT00453752|"~     The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in systemic sclerosis~     patients and to establish whether it reflects the severity of RV overload.~   "
236960|NCT00453700|"~     Chagas disease is endemic to the Americas, infecting between 16-18 million individuals. In~     immigrant populations in the United States from endemic areas, it is estimated up to 4.9% may~     be asymptomatic carriers of Trypanosoma cruzi, the organism which causes Chagas disease.~     Between 10-20% of these patients progress to development of end-stage cardiomyopathy with a~     high associated morbidity. Following acute disease, patients enter into an indeterminate~     phase which can last 10-20 years. The earliest sign of cardiac involvement usually is~     electrocardiogram abnormalities. The most common abnormality is right bundle branch block~     (RBBB), followed by left anterior fascicular block (LAFB), and left bundle branch block~     (LBBB). Recent studies have shown that treatment of patients at this stage with~     antiparasitics may delay the progression of overt cardiomyopathy.~      At the University of California, Los Angeles, there is a large population of immigrant~     patients from countries endemic to Chagas disease. The researchers propose that screening~     patients with conduction abnormalities on electrocardiogram may be a potentially useful~     method to identify patients with early cardiac manifestations of Chagas disease. The~     researchers hope to enroll approximately 300 individuals with RBBB, LAFB or LBBB on~     electrocardiogram to determine the incidence of Chagas disease in this patient population.~   "
236961|NCT00453687|"~     This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a~     new formulation.~   "
236962|NCT00453674|"~     Basic objective of the German Adrenocortical Carcinoma Registry is to improve the care of~     patients with adrenocortical cancer. The registration of as many patients as possible helps~     to collect data for the prognosis and prospects of success regarding different treatment~     plans. This data will be taken into consideration for planning prospective studies. With this~     registry, the recruitment of patients for prospective studies will be significantly~     facilitated. In this way - and in cooperation with networks in other countries (e.g. in Italy~     and France) - a structure allowing systematic improvement of therapy will be developed.~   "
236963|NCT00453661|"~     The goal of this behavioral research study is to improve the use of cancer prevention~     services, increase early detection, and treatment of cancer. A secondary outcome of this~     demonstration project proposes that a structured patient navigator (PN) will reduce the cost~     of Medicare services.~   "
236964|NCT00453648|"~     The primary purpose of this study is to determine whether daily consumption of orange-fleshed~     sweet potatoes increases the vitamin A status of Bangladeshi women of reproductive age.~     Secondary purposes of the study are to determine whether consumption of orange-fleshed sweet~     potatoes has an effect on the intestinal absorption of dietary iron or dietary zinc in~     Bangladeshi women of reproductive age.~   "
236965|NCT00453635|"~     This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin~     and Herceptin versus the administration of Vinorelbine and Herceptin combination as first~     line treatment in HER-2 positive patients with metastatic breast cancer.~   "
236966|NCT00453622|"~     The purpose of the study is to identify if the combined use of cardiac troponin enzyme (cTnT)~     and brain natriuretic peptide (BNP) can predict Heart Failure (HF)improvement and all-cause~     mortality in patients implanted with cardiac pacemaker-defibrillation devices (CRT-D). Novel~     biochemical markers identifying patients with high risk cardiac mortality detected by plasma~     protein analysis will also be evaluated.~      Hypothesis #1: The combined use of cTnT and BNP at just before implant will predict and risk~     stratify all cause mortality or HF hospitalization up to 12 months.~      Hypothesis #2: The change in levels of said biomarkers at different points of follow-up can~     predict response to CRT through 12 months.~      Hypothesis #3: The levels of a panel of novel inflammatory mediators, namely chemokines, will~     be correlated with improvement in 6-minute walk testing, quality of life, and left~     ventricular ejection fraction in CRT patients.~   "
236967|NCT00453609|"~     The overall goal of this project is to improve the treatment of alcohol dependence in~     patients with serious mental illness (SMI). SMI for this study is defined as any patient with~     any of the following diagnoses: schizophrenia, schizoaffective disorder, and bipolar type I~     or type II disorder. Alcohol and other substance use disorders (SUDs) are common among~     individuals with SMI. SUD comorbidity is associated with many adverse consequences. However,~     to date, few reports have addressed the efficacy of pharmacological treatments for SUDs in~     this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence,~     but it has not been systematically applied to the care of patients with SMI. The primary aim~     of this study is to determine the feasibility of long-acting injectable naltrexone~     administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol~     dependence. Secondary aims include providing a preliminary assessment of the tolerability and~     safety of long-acting injectable naltrexone in patients with SMI who also have a diagnosis of~     alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy~     of long-acting injectable naltrexone in reducing alcohol use from baseline levels.~   "
236968|NCT00453596|"~     Impaired endometrial growth (thin endometrial thickness) is a critical factor for~     implantation failure. In this study, effects of vitamin E on endometrial growth are studied.~   "
236969|NCT00453583|"~     This is a non-interventional retrospective data collection study from children aged from 2 to~     12 years old diagnosed with an allergy and who received a treatment consisting of an~     H1-antihistamine. The period of last taken medication will be observed to evaluate the global~     satisfaction of the parents and physician for this last treatment.~   "
236970|NCT00453570|"~     As per request by the Heath Authorities, the present clinical study will assess the~     immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™)~     as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age~     followed by a booster dose at 18-20 months of age as compared to commercially available~     DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet~     the requirements for registration of the product in People's Republic of China.~   "
236971|NCT00453557|"~     Growth hormone treatment in humans has been shown to decrease body fat. This study aims to~     determine what adipose tissue depots are affected by GH and what is the mechanism.~   "
236972|NCT00453544|"~     The purpose of this study is to evaluate the efficacy of an enhanced consent procedure for~     patients with mild-to-moderate Alzheimer disease, and to identify factors and patient~     characteristics that predict the degree to which enhanced consent is more beneficial than~     routine consent procedures.~   "
236973|NCT00453531|"~     This study will develop a model system that can be used to test medications for improving the~     ability of blood vessels to resist damage from diseases such as heart attack and stroke. The~     endothelium (inner layer of blood vessels) has built-in defense mechanisms to prevent~     blockage of blood flow, including the ability to stretch the vessel when it senses that blood~     flow is threatened. People with heart attack risk factors, such as high cholesterol, smoking~     and diabetes lose this ability. This study will develop a model that can measure the response~     to a lack of blood flow in the arm and be used to test new medicines to improve blood vessel~     health.~      Healthy males between 18 and 45 years of age who have no history of high blood pressure, high~     cholesterol, or diabetes and who have not smoked for at least 3 months before entering the~     study may be eligible to enroll.~      Participants lie in an adjustable reclining bed. Small catheters (tubes) are placed in the~     artery and vein of the forearm of the non-dominant arm at the inside of the elbow. Blood~     samples are collected from the tubes. Then, pressure cuffs are placed on both wrists and~     upper arms. A strain gauge (rubber band-type device) is placed around the forearms. The~     pressure cuffs are inflated and blood flows into the forearm, stretching the strain gauge at~     a rate proportional to the blood flow. Then, small doses of acetylcholine (a medicine that~     causes blood vessels to expand) are injected into the artery tube. After 20 minutes, blood~     flow to the non-dominant arm is blocked by inflating the pressure cuff. The subject squeezes~     a rubber ball about every 2 seconds for 90 seconds. The cuff is deflated after 15 minutes and~     blood samples are withdrawn from the tube in the vein. After 15 minutes, the procedure is~     repeated one more time.~   "
236974|NCT00453518|"~     This is a multicenter, prospective study designed to demonstrate the performance and safety~     of the FiberNet Embolic Protection System when used as an adjunctive device during saphenous~     vein graft (SVG) intervention.~   "
236975|NCT00453505|"~     Objectives~      Noninvasive stimulation of the central and peripheral nervous system, including transcranial~     magnetic stimulation (TMS), theta-burst TMS (TBS), transcranial direct current stimulation~     (tDCS) and cutaneous/peripheral nerve stimulation (CPNS) alone or paired with TMS (paired~     associative stimulation, PAS), has been increasingly used in the investigation of cortical~     plasticity and as a possible adjuvant strategy in neurorehabilitation. It has been shown that~     TMS, TBS, tDCS and CPNS can successfully modulate motor function in healthy volunteers, as~     well as in patients with neurological disorders such as stroke.~      One fundamental problem is that the optimal parameters of stimulation to modulate motor~     function by all of these techniques are not known. The purpose of this protocol is to explore~     within safe guidelines, the effects of different stimulation parameters on motor cortical~     function, on oscillatory brain dynamics measured with magnetoencephalography (MEG) and~     electroencephalography (EEG), on eye movements, and on fMRI activation. In addition, this~     protocol will be used to train new fellows coming to NINDS Human Cortical Physiology Section~     (HCPS) in the use of TMS, TBS, tDCS, and CPNS techniques.~      We expect that information emerging from these studies will allow us to 1)optimize the~     stimulation parameters to collect pilot data in healthy volunteer for future patient-oriented~     hypothesis-driven protocols,2)to collect pilot data for power analysis for future~     patient-oriented hypothesis driven protocols, and 3) to train new fellows in the use of these~     different methods.~      Study Population~      Up to 1000 healthy volunteers, age 18 and older.~      Design~      Healthy volunteers will receive one or more of the following types of stimulation alone or in~     combination: (1) 1 Hz TMS for up to 30mins and up to 115% of resting motor threshold~     intensity (MT). These parameters are not being used for single-pulse TMS and paired-pulse~     TMS. Parameters for single-pulse TMS and paired-pulse TMS are variable as they depend on the~     sub-study. For paired pulses, duration of each TMS pulse is up to 1 msec. Interval between~     pulses is up to 20 sec and intensity of stimulation is up to 100 % of stimulator s output~     depending on the sub-study. (2) TBS below 100% active MT; (3) tDCS up to 2 mA for up to~     60mins (4) CPNS with intensities below 130% of the peripherally-elicited-motor-threshold for~     up to 2 hours. All of these parameters of stimulation and procedures have safely been used as~     previously reported in the literature. Sham stimulations will be delivered for each modality.~      Each subject may undergo up to 20 sessions spaced by at least one day, depending on the~     particular exploration. To verify that the number of sessions per subject does not exceed 20~     sessions, the number of sessions per participant is tracked across substudies using CTDB. The~     AIs are responsible for entering into CTDB the subjects/visits. We will test the effects of~     these different forms of stimulation on motor cortical excitability, simple motor tasks, and~     functional neuroimaging measures. Some stimulation may be conducted before, after, or during~     fMRI scans, eye movement recording, MEG and/or EEG recording sessions. To identify the~     possible contribution of sub-cortical structures, we will also measure M-wave, F-wave, and/or~     H-Reflexes. The goal of these exploratory studies is to obtain preliminary information on the~     effects of these various combinations of central and peripheral nervous system stimulation~     that would allow us to develop subsequent, finely tuned, hypothesis-driven protocols.~      Under this protocol, we conduct:~      Exploratory Sub-studies. These substudies are exploratory in nature and are conducted in~     order to develop information to generate better informed hypotheses and/or power analyses. We~     have set an upper limit of 40 subjects per sub-study.~      Hypothesis-Testing Sub-studies. Hypothesis-testing sub-studies are studies with specific~     hypotheses to be tested. These sub-studies undergo statistical and PIRC review after 6~     subjects per group (e.g., after 12 subjects, 6 per arm, if two groups are studied), before~     additional subjects can be recruited. Together, the P.I. and PIRC will decide whether to~     continue the sub-study with more subjects without an amendment or whether an amendment or~     protocol would be necessary. A memo requesting a review of hypothesis-testing sub-studies for~     possible additional enrollment (beyond 6) will be sent to PIRC and the statistical reviewer.~      In addition to the sub-study types above, this protocol is used to train new investigators~     and optimize various techniques and experimental approaches (e.g., appropriate MRI sequences,~     parameters of TMS stimulation, behavioral training duration).~      We devised a strategy to ensure that a sub-study engages only procedures authorized in~     protocol and consent form and is scientifically valuable. F...~   "
236976|NCT00453492|"~     The primary objective is to compare subject satisfaction of once a week dosing of 35 mg~     Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.~      The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and~     urinary NTx (N-telopeptides) (optional)].~   "
236977|NCT00453479|"~     GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being~     developed for the treatment of chronic obstructive pulmonary disease. This is a randomised,~     double-blind, placebo-controlled, dose ascending, parallel group study to examine the safety,~     tolerability, pharmacokinetics and pharmacodynamics of twice daily inhaled doses of~     GSK233705B for 7 days, in COPD subjects.~   "
236978|NCT00453466|"~     Intimate partner violence against women is a significant global health problem. This study~     was designed to test the hypothesis that a group intervention based on empowerment theory of~     Paolo Freire would be effective as a means to reduce the extent and prevent violence among~     women whose partners were violent toward them.~   "
236979|NCT00453453|"~     The investigators hypothesize that patients admitted to an emergency department (ED)~     observation unit will have a decreased rate of hospital admissions and ED recidivism when~     treated with nesiritide versus standard therapy. The investigators also hypothesize that~     decreasing B-type Natriuretic Peptide (BNP) levels during treatment in an ED observation unit~     will predict improved patient outcomes.~   "
236980|NCT00453440|"~     This is a study to determine the prevalence of a genetic marker, HLA-B5701, in the UK~     population. HLA-B*5701 has been strongly associated with the risk of an allergic reaction to~     a HIV medicine, Abacavir. The allergic reaction is known as a hypersensitivity reaction.~      The study is a prospective study inviting HIV-1 positive patients over the age of 18 years to~     participate. Each participant will complete one study visit. They will be asked for details~     of their background including their age, sex, ethnicity, country of origin and parental~     country of origin.~      They will be asked to give two samples to test for the presence of the genetic marker~     HLA-B*5701. The two samples are:~        -  A cheek swab~        -  A blood sample~      In selected centres patients may be asked to provide up to two additional blood samples.~     These samples will be used to help develop and validate new methods of determining HLA-B*5701~     testing.~   "
236981|NCT00453427|"~     The primary objectives of this study are to:~        1. establish the safety and dose limiting toxicities of combining alemtuzumab with CHOP~          chemotherapy for patients with newly diagnosed aggressive T-cell lymphomas; and~        2. to measure the pharmacokinetics of alemtuzumab used in different subcutaneous doses and~          schedules.~      This will then determine the dose with the highest achievable drug levels with acceptable~     toxicities worthy of further investigation.~      The secondary objectives are to:~        1. establish the efficacy of combination alemtuzumab with CHOP chemotherapy; and~        2. to measure the effects of combination alemtuzumab with CHOP chemotherapy on T-cell~          reconstitution and cytomegalovirus (CMV) reactivation.~   "
236982|NCT00453414|"~     The purpose of this study is to evaluate the safety and effectiveness of iloprost for PAH in~     children who are between the ages of 3 and 18 years old.~   "
236983|NCT00453401|"~     Purpose of this study is to determine the safety and efficacy of topical applications of~     NB-001 as compared to placebo for the treatment of recurrent herpes labialis.~   "
236984|NCT00453388|"~     This phase II trial studies how well total-body irradiation (TBI) works when given together~     with fludarabine phosphate and cyclophosphamide followed by donor bone marrow transplant,~     mycophenolate mofetil, and cyclosporine in treating patients with Fanconi anemia (FA). Giving~     low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and TBI before~     or after a donor bone marrow transplant helps stop the growth of abnormal cells. It may also~     stop the patient's immune system from rejecting the donor's stem cells. The donated stem~     cells may replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving mycophenolate mofetil and~     cyclosporine after the transplant may stop this from happening.~   "
236985|NCT00453375|"~     The purpose of this study is to determine the safety of BHT-3021 injections given weekly for~     12 weeks and to evaluate the effect of BHT-3021 on antibody and immune (T cell) responses to~     autoantigens (e.g. insulin). Changes in pancreatic beta cell function, insulin requirements~     and blood glucose levels will also be evaluated.~   "
249566|NCT00285857|"~     The study evaluates if a 6-month course of oral lovastatin at 80 mg/day would decrease~     abnormal breast duct cytology in women with a high inherited breast cancer risk.~   "
236986|NCT00453362|"~     This is a single-arm, open-label, multicenter, international pilot study to evaluate changes~     that occur in 2-deoxy-2-[18F]fluoro-D-glucose (FDG)- and~     3'-deoxy-3'-[18F]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result~     of treatment with erlotinib in patients with recurrent or refractory non−small cell lung~     cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in~     Australia and 2 sites in the United States.~   "
236987|NCT00453349|"~     To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus~     oral metronidazole in uncomplicated pelvic inflammatory disease (PID)~   "
236988|NCT00453336|"~     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a~     certain kind of light. When the drug is active, precancerous cells and cancer cells are~     killed.~      PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy~     with porfimer sodium works in treating patients with precancerous lesions, cancer, or other~     disease of the aerodigestive tract.~   "
236989|NCT00453323|"~     Capecitabine is an orally administered fluoropyrimidine that is converted by 5-FU by~     thymidine phosphorylase (TP), preferentially in tumor tissues and has demonstrated activity~     as single agent in patients with gastrointestinal cancer. Up-regulation of TP after taxane~     treatment in vitro suggested that there may be synergistic effects in combined treatment with~     taxane and capecitabine. The combination of taxane and capecitabine was reported to be highly~     active against non-small cell lung cancer, breast cancer, and stomach cancer.~   "
236990|NCT00453310|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     metastatic germ cell tumors that have relapsed or not responded to treatment.~   "
236991|NCT00453297|"~     This Phase I trial in healthy, post-menopausal women is designed as a double-blind,~     placebo-controlled, randomized, ascending single-dose safety trial. MF101 will be~     administered as a single oral dose to a total of 32 enrolled subjects between the ages of~     40-65 years. Eight subjects will be assigned to each of four cohorts. Within each cohort, six~     subjects will be randomized to receive MF101 and two subjects will receive placebo. MF101~     doses will be incrementally escalated until the stopping criteria are reached. If stopping~     criteria are reached before the fourth cohort receives dosing, the next cohort may receive a~     dose between the dose that was administered to the cohort exhibiting symptoms of MF101~     toxicity and the next lower dose group.~   "
236992|NCT00453271|"~     The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and~     effective in the treatment of distal subungual onychomycosis of the toenail.~   "
236993|NCT00453258|"~     The significance of our study is in the importance of understanding the quality and quantity~     of proteins in the human tear film from diseased and non-diseased patients. This pilot study~     will provide data to plan prospective research to better delineate the utility of tear~     proteins in diagnosing and following disease status in a non-invasive fashion.~   "
236994|NCT00453245|"~     To examine the clinical genetic and biochemical characteristics of children with growth~     hormone deficiency.~   "
236995|NCT00453232|"~     RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the~     number of immune cells found in bone marrow or peripheral blood and may help the immune~     system recover from the side effects of chemotherapy. Giving combination chemotherapy~     together with pegfilgrastim may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving combination~     chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell~     tumors.~   "
236996|NCT00453219|"~     Functional Hypothalamic Amenorrhea (FHA), the spontaneous cessation of the menstrual cycle~     for at least 6 months after menstrual cyclicity has been established, is a common and~     reversible form of anovulation not due to discernible organic causes. Whereas animal studies~     suggest an interaction of metabolic and psychosocial stress in the genesis of FHA, the~     distinct central mechanisms in humans are not clear. On a behavioral level, FHA appears to~     depend on a complex interplay between individual stress susceptibility, stressful life~     events, and enduring metabolic challenge due to inappropriate attitudes towards eating and~     body image. We will use a comparison group of ovulatory, eumenorrheic women (EW) and a~     contrast group of lean women with polycystic ovary syndrome (PCOS). Although women with FHA~     and PCOS present with anovulation, each condition differs markedly in pathobiology (and~     health burden). Contrasting women with FHA to those with PCOS will afford an opportunity to~     understand more about the interaction between metabolism, stress, and reproduction and to~     determine the extent to which differences between FHA and EW are attributable to reproductive~     compromise (anovulation) per se versus specific to the pathogenesis of FHA or PCOS. We have~     used this approach to great advantage in the past to show that hypercortisolemia was confined~     to FHA and not PCOS (Berga 1997) and that dysfunctional (unrealistic) attitudes and decreased~     coping skills were reported more often in FHA than in PCOS and more in PCOS than EW. Further,~     this approach of comparing 3 groups will allow us to improve therapeutic approaches for two~     principle causes of anovulatory infertility in women. To accomplish this, we will study women~     with FHA, PCOS, and normal ovulatory women. The study will take place over 2 months and women~     will make 4-5 outpatient visits to the Clinical Integration Network Center and will have one~     overnight stay for frequent blood sampling.~   "
236997|NCT00453206|"~     RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor~     peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or~     abnormal cells. It also helps stop the patient's immune system from rejecting the donor's~     stem cells. When the healthy stem cells from a donor are infused into the patient they may~     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells. Giving tacrolimus, methotrexate, mycophenolate mofetil, and~     antithymocyte globulin before and after transplant may stop this from happening. Once the~     donated stem cells begin working, the patient's immune system may see the remaining cancer or~     abnormal cells as not belonging in the patient's body and destroy them (graft-versus-tumor~     effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may~     boost this effect.~      PURPOSE: This phase II trial is studying how well donor stem cell transplant works in~     treating patients with hematologic cancer or other diseases.~   "
236998|NCT00453193|"~     The goal of this clinical research study is to learn if giving pentostatin with alemtuzumab~     can help to control T-cell malignancy. The safety of this combination therapy will also be~     studied.~   "
237000|NCT00453167|"~     As a single agent, paclitaxel has a response rate of 33% and 25-29% in SCLC patients with~     sensitive relapse and with resistant relapse, respectively. As a single agent, gemcitabine~     also has a response rate 16% and 6-13% in SCLC patients with sensitive relapse and with~     resistant relapse, respectively. Because of single-agent activity, different mechanism of~     action, non-overlapping toxicities, and beneficial pharmacologic interaction, paclitaxel and~     gemcitabine combinations are attractive for testing in clinical trials.~   "
237001|NCT00453154|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     sunitinib malate and to see how well it works when given together with cisplatin or~     carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer.~     Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether~     cisplatin or carboplatin and etoposide are more effective when given with or without~     sunitinib malate in treating small cell lung cancer.~   "
237002|NCT00453141|"~     The purpose of this study is to determine if there may be a benefit to the newborn if~     betamethasone is given 12 hours apart instead of 24 hours apart.~   "
237003|NCT00453128|"~     The purpose of this study is to determine whether thorough analytical evaluation is useful to~     diagnose metabolic conditions associated to calcium pyrophosphate deposition disease.~   "
237004|NCT00453115|"~     Oxaliplatin is a diaminocyclohexane platinum compound, with a mechanism of action similar to~     that of cisplatin. Oxaliplatin has a more manageable toxicity profile than cisplatin, with no~     renal toxicity and a lower incidence of hematological and gastrointestinal toxicities.~     Gemcitabine and oxaliplatin are both active in NSCLC with no overlapping toxicity.~     Preclinical studies show a synergistic effect of the gemcitabine-oxaliplatin combination. The~     combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the~     therapeutic index.~   "
237005|NCT00453102|"~     Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).~   "
237006|NCT00453089|"~     To conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical~     trial in 4 cohorts of 10 postmenopausal women (total N=40) aged 45 to 65 years with at least~     one menopausal vaginal symptom, vaginal pH > 5.0 and > 20% parabasal vaginal epithelial~     cells.~   "
237007|NCT00453076|"~     The primary goal is to determine stent patency and overall survival of the conventional~     covered self expandable metallic stent versus paclitaxel eluting covered self expandable~     metallic stent in unresectable malignant bile duct stricture.~      The secondary goals are to assess reinterventions, complications, technical difficulties, and~     physician graded ease of placement and to assess toxicity of paclitaxel eluting covered self~     expandable metallic stent.~   "
237008|NCT00453063|"~     This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS)~     once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in~     reducing the total nasal symptom score and the total ocular symptom score.~   "
237009|NCT00453050|"~     RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in~     different ways and stop tumor cells from growing. Laser therapy uses light to kill tumor~     cells. Giving imiquimod together with laser therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with~     or without a green dye in treating patients with stage III or stage IV melanoma that has~     spread to other parts of the skin.~   "
237010|NCT00453037|"~     The purpose of this study is to evaluate the effects of a structured educational program for~     hypertensive patients. The program was developed at the University of Dusseldorf, Germany.~     The contents of the program are as follows: teaching of the background of hypertension,~     techniques of self estimation of blood pressure, life style and dietary habits, some~     information concerning the different pharmacological properties to treat hypertension~   "
237011|NCT00453024|"~     When implanting an Ahmed glaucoma tube, a scleral flap is usually created to cover the tube,~     and the conjunctiva is stitched back in place with nylon 10-0 sutures. It is hypothesized~     that an equally safe or better method is using a bovine pericardial patch graft that can be~     secured in place over the tube with tissue glue, and using tissue glue to reposition the~     conjunctiva in place.~   "
237012|NCT00453011|"~     Objective: The standard definition of failure in cataract surgery is best corrected visual~     acuity of less than 20/40 at one year. The specific aim of this cooperative study was to~     compare the failure rate for those patients with vitreous loss in whom an PC IOL is placed to~     the failure rate for those in whom an AC IOL is placed after vitreous loss.~      Design: A total of 437 patients in 15 centers were randomized to AC or PC IOL over a 45-month~     period and were followed for a minimum of one year. The null hypothesis is that the rate of~     failure is the same in the two groups.~      All patients who were about to undergo cataract surgery in the participating centers and who~     did not meet an exclusion criterion were eligible for the study. At the time of surgery, if~     there was vitreous loss, and if in the opinion of the surgeon there was sufficient capsular~     support for a posterior chamber lens to be placed, then the patient was randomized into one~     of either the anterior or posterior chamber lens groups. The patients were then followed for~     complications (e.g., retinal detachment, cystoid macular edema, uveitis, glaucoma, hyphema)~     and for the primary end point of visual acuity of 20/40 or better at one postoperative year.~      An Index Group of about 500 patients without vitreous loss also were followed according to~     study protocol. These patients were compared to those in the PC and AC IOL groups with~     respect to outcome and baseline characteristics in order to assess the effect of vitreous~     loss on complication rates.~      All patients were followed at annual intervals until the termination of the study. This~     allowed the study to obtain long-term information with regard to visual acuity and~     complication rates.~   "
237013|NCT00452998|"~     Sequential Laser Iridotomy uses argon and Nd:yag laser in the first and second steps,~     respectively. Using q-switched 532 nm laser in the second step is hypothesized to be as good~     and effective as the conventional Nd:yag laser, because it selectively targets pigmented~     cells and delivers a short pulse duration of 3 nanoseconds, causing less thermal and~     collateral damage.~   "
237016|NCT00452920|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells.~     Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together~     with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when~     given together with radiation therapy and to see how well they work in treating patients with~     stage II, stage III, or stage IV cervical cancer.~   "
237017|NCT00452907|"~     Test the hypothesis that repeated administration of Artesunate/Amiodaquine,~     Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of~     consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated~     falciparum malaria and malaria attributable anemia~   "
237018|NCT00452894|"~     This study is to measure how much of varenicline tartrate is in Chinese healthy smokers'~     blood and urine after taking a single dose and several doses respectively, and also to test~     the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline.~   "
237019|NCT00452881|"~     Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and~     a lower incidence of hematological and gastrointestinal toxicities. The combination of~     gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic~     index. Given the potential advantages of oxaliplatin and th finding that the addition of~     chemotherapy improves survival in the postoperative adjuvant setting, we conduct a phase II~     trial to compare adjuvant gemcitabine-oxaliplatin with gemcitabine-cisplatin in patients with~     completely resected stage IB, II or IIIA NSCLC~   "
237020|NCT00452868|"~     RATIONALE: Donepezil may decrease the side effects caused by radiation therapy to the brain.~      PURPOSE: This clinical trial is studying how well donepezil works in treating young patients~     with primary brain tumors previously treated with radiation therapy to the brain.~   "
237021|NCT00452855|"~     The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is~     similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.~   "
237022|NCT00452842|"~     An observational safety follow up trial will be conducted to monitor the occurrence of~     cardiovascular events and all cause mortality in subjects who participated in selected~     torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials. No hypotheses will be tested.~   "
237023|NCT00452829|"~     The aim of the study is to develop a randomised, double blind clinical trial to compare (i)~     folic acid plus inositol, with (ii) folic acid plus placebo, for prevention of recurrent~     neural tube defects.~   "
237024|NCT00452816|"~     The objective of the project is to understand how best to help mid-size employers adopt~     evidence-based chronic disease prevention practices that improve employee health behaviors.~   "
237025|NCT00452803|"~     It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with~     or without radiotherapy followed by surgery provides a potentially superior method of~     enhancing resectability and improving locoregional control and survival compared to~     radiotherapy alone followed by surgery. Unsolved questions are the identification of the best~     induction strategy, the impact of surgery on long-term survival, and the contribution of~     radiation therapy in this setting. Thus, the investigators conduct a phase II trial to~     compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy~     proven N2 stage IIIA NSCLC to address optimal induction strategy.~   "
237026|NCT00452790|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given~     concomitantly with routine paediatric vaccinations in India.~   "
237027|NCT00452777|"~     The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in~     diabetic patients with neuropathic pain who are either not on analgesia or are on stable~     analgesia in the month prior to entering the study.~   "
237028|NCT00452764|"~     Lymphoid follicles, consisting of T-and B cells, are involved in the chronic inflammatory~     response in COPD. Foxp3 positive regulatory T cells (Tregs) are present in these follicles~     and may be involved in the suppression of this chronic inflammatory response.~      We hypothesise that a dysfunction of Tregs underlies the development of the inflammatory~     response in COPD. This could be either due to a decreased presence of Tregs in COPD, or to an~     altered function of Tregs possibly caused by a decreased HO-1 expression and/or an altered~     TGFβ regulation.~   "
237029|NCT00452751|"~     The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric~     cancer in comparison with open gastrectomy.~   "
237030|NCT00452738|"~     The objective of this study is to examine the effects of pre surgery dog visits as compared~     to a costumed character or parents-only on the consumption of pain medication after surgery.~     It is hypothesized that pre surgery dog visits will reduce post surgical stress and anxiety.~   "
237031|NCT00452725|"~     1. Clinical Objective : To improve the growth of these children~        2. Genetic objective : A study of the genetics of the syndrome~   "
237032|NCT00452712|"~     Objective:to determent if children suffering from acute febrile illness has higher rate of~     orthostatic hypotension compared with children with no febrile illness. Design: a prospective~     cohort study. Subjects: children aged 4-18 year with fever (temperature > 38.) for up to 48~     hours, presenting to the pediatric emergency department. Interventions: All subjects will~     have their blood pressure measured in supine position (after 5 minute of rest) and after 3~     minute of standing.~   "
237033|NCT00452699|"~     This purpose of this study is to show the superiority and long term safety and efficacy of~     adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid~     (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of~     asthma control will provide key information on the efficacy and safety of the combination~     therapy. The safety measure will be an assessment of adverse events~   "
237034|NCT00452686|"~     This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals'~     reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in~     comparison with Chinese DT vaccine, in children 6-8 years of age.~   "
237035|NCT00452673|"~     The purpose of this study is to learn about the safety and efficacy of Dasatinib in~     combination with Capecitabine for patients with advanced breast cancer, and who have received~     treatment with a taxane and an anthracycline~   "
237036|NCT00452660|"~     Certain percentage of MDS patients develop iron overload. Iron is known to participate in~     intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis,~     which was found to be increased in MDS patients and consequently resulted in ineffective~     hematopoiesis. The aim of this study is to evaluate the antioxidant effect of the oral iron~     chelator Deferasirox -Exjade in low risk MDS patients with iron over load by evaluating~     changes in several oxidative stress parameters Certain percentage of MDS patients develop~     iron overload.~   "
237037|NCT00452647|"~     The purpose of this study is to observe and analyze variation of diastolic blood pressure~     measurements at third trimester of pregnancy and when they present for delivery in comparison~     to healthy volunteers.~      When patients present for delivery, we expect blood pressure to be lower than normal. However~     this is not the case. We aim to determine where this trend occurs throughout to duration of~     pregnancy, and propose possible explanation as to the source of this event.~      After discharge, the information recorded includes each patient's blood pressure upon~     admission to the labor floor, and several blood pressure measurements from prior clinical~     visits.~   "
237038|NCT00452634|"~     3-Hydroxy-3-methylglutaryl CoA reductase inhibitors, commonly referred to as the statins,~     have proven therapeutic and preventative effects in cardiovascular diseases. Recently, there~     are emerging interests in their use as anticancer agents based on preclinical evidence of~     their antiproliferative, proapoptotic, anti-invasive, and radiosensitizing properties.~     Inhibition of 3-hydroxy-3-methylglutaryl CoA reductase by the statins interferes with the~     rate-limiting step of the mevalonate pathway, leading to reduced levels of mevalonate and its~     downstream products, many of which play important roles in critical cellular functions such~     as membrane integrity, cell signaling, protein synthesis, and cell cycle progression.~     Perturbations of these processes in neoplastic cells by the statins may therefore result in~     control of tumor initiation, growth, and metastasis. The statins have demonstrated growth~     inhibitory activity in cancer cell lines and preclinical tumor models in animals.~     Simvastatin, a member of the statin family, profoundly impaired basal and growth~     factor-stimulated SCLC cell growth in vitro and induced apoptosis. SCLC cells treated with~     simvastatin were sensitized to the effects of the chemotherapeutic agent etoposide. Moreover,~     SCLC tumour growth in vivo was inhibited by simvastatin. Therefore, the investigators will~     conduct this phase II trial to evaluate the efficacy & toxicity of irinotecan/cisplatin plus~     simvastatin in patients with chemo-naïve ED-SCLC.~   "
237039|NCT00452621|"~     blood draw five years after booster-immunization with TBE vaccine to investigate~     immunogenicity in children~   "
237040|NCT00452608|"~     The purpose of this study is to determine whether atorvastatin can improve the inflammatory~     answer in the septic patients~   "
237041|NCT00452595|"~     To evaluate the long-term safety of desvenlafaxine sustained release (DVS-233SR) during~     open-label treatment of outpatients with major depressive disorder (MDD).~   "
237042|NCT00452582|"~     Stroke is the third leading cause of death in the United States and the leading cause of~     serious long-term disability. Approximately 50% of the 750,000 people affected by stroke each~     year have residual physical impairment. Treatment options for recovery are limited at this~     time. Sildenafil (Viagra) has demonstrated the capability of significantly improving recovery~     in several animal experiments of stroke. This study is aiming to establish the safety of~     treatment with sildenafil in people with stroke with the ultimate aim of testing its~     usefulness to improve recovery.~   "
237043|NCT00452569|"~     The primary objective is to compare the time to progression (TTP) of three daily doses of~     thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory~     multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in~     terms of median TPP and toxicity.~   "
237044|NCT00452556|"~     The purpose of this study is to see if sequence inversion of Intensity - modulated~     Radiotherapy (IMRT) for prostate cancer, can improve the safety and deliverability of~     concurrent docetaxel chemotherapy with long - term hormonal therapy. The hypothesis is that~     inverting the traditional sequence of radiotherapy can delay the time to treatment - induced~     bowel toxicity.~   "
237045|NCT00452543|"~     This is a study about treatment for people who suffer from both major depression and alcohol~     abuse or dependence. The study will examine whether the addition of acamprosate to~     escitalopram and behavioral interventions will improve outcomes for this population.~   "
237046|NCT00452530|"~     The purpose of this study is to learn whether apixaban prevents the development of blood~     clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur~     after knee replacement surgery, and to compare the efficacy of apixaban with that of~     enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be~     studied.~   "
237047|NCT00452517|"~     During the 6-month period 119 patients with acute coronary syndrome, were randomized to~     either stent graft group (n=40), sirolimus eluting stent group (n=39), or bare metal stent~     group (n=40). Demographic, angiographic and procedural characteristics were similar for all~     three groups. The incidence of 6-month major adverse coronary events were analysed.~   "
237048|NCT00452504|"~     This is a first-in-humans study of SRA-444. This study will provide an initial assessment of~     the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR~     formulation) after administration of ascending single oral doses to healthy adult subjects.~   "
237049|NCT00452491|"~     1. To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens~        2. To specify the best period of treatment~        3. To assess the efficacy of treatment based on final adult height of these children~   "
237050|NCT00452478|"~     The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to~     patients on haemodialysis works as well as other treatments currently used to lower blood~     phosphorus levels.~   "
237051|NCT00452465|"~     Hypothesis: It is hypothesized that older adults who receive the ElderCare intervention will,~     when compared with a control group of older adults show a significant improvement in quality~     of life,a significant decrease in symptomatology, significantly higher satisfaction with~     their care, and less utilization of health care resources.~      The Eldercare project involves a detailed assessment by a nurse done in the patients home,~     followed by the development and delivery of a Eldercare Plan using a Goal Attainment Scaling~     approach.~      Outcomes include quality of life, symptomatology, satisfaction, and health care utilization.~   "
237054|NCT00452426|"~     Patients routinely receive sedation during a colonoscopy or upper endoscopy~     (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during~     these procedures. The purpose of this study is to determine if this CAPS device enables a~     physician/registered nurse (RN) team to safely and effectively administer propofol sedation~     during colonoscopy or EGD procedures relative to current sedation practices.~   "
237055|NCT00452413|"~     Phase I: A study to see what doses of Enzastaurin and Erlotinib are best tolerated by~     participants with solid tumor cancer.~      Phase II: A study to see how long participants with non-small cell lung cancer (NSCLC)~     treated with Enzastaurin and Erlotinib live.~   "
237056|NCT00452400|"~     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL~     inhalation solution delivered by the Respimat® inhaler for four weeks in patients with~     chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be~     based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and~     pharmacokinetic evaluations (the amount of the medication found in your blood).~   "
237057|NCT00452387|"~     The purpose of this research study is to determine if the combination of mitoxantrone,~     prednisone and sorafenib will improve the time to progression of advanced stage metastatic~     hormone-refractory prostate cancer.~   "
237058|NCT00452374|"~     Primary Objectives:~        1. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of~          oxaliplatin in combination with fludarabine, Ara-C and rituximab in patients with~          Richter's transformation, prolymphocytic leukemia (PLL), or refractory/relapsed B-cell~          chronic lymphocytic leukemia (CLL).~        2. Assess the complete response (CR) and partial response (PR) rate to combination therapy~          of oxaliplatin, fludarabine, Ara-C and rituximab in patients with Richter's~          transformation, PLL or refractory/relapsed B-cell CLL.~        3. Determine the safety and toxicity profile of combination therapy of oxaliplatin,~          fludarabine, Ara-C and rituximab in patients with Richter's transformation, PLL or~          refractory/relapsed B-cell CLL.~      Secondary Objectives:~        1. Determine the duration of response, failure-free survival, and overall survival.~        2. Determine the incidence of infections (bacterial, fungal, and viral) in patients with~          Richter's transformation, prolymphocytic leukemia or refractory/relapsed B-cell CLL~          treated with rituximab, oxaliplatin, fludarabine and Ara-C; monitor immune parameters~          such as T cell counts and immunoglobulin levels; and monitor Epstein-Barr virus (EBV)~          status.~        3. Characterize the pharmacodynamics of oxaliplatin in leukemia cells with respect to total~          adduct formation, cross-link formation and excision deoxyribonucleic acid (DNA)~          responses. Compare these parameters in cells from the same patient after treatment with~          oxaliplatin in combination with fludarabine and Ara-C.~   "
237059|NCT00452361|"~     This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI)~     to sirolimus (SRL) results in improved long-term renal function without a negative impact on~     safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce~     the severity and/or progression of chronic allograft nephropathy (CAN).~   "
237060|NCT00452348|"~     This purpose of this study is to show the superiority and long term safety and efficacy of~     adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid~     (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of~     asthma control will provide key information on the efficacy and safety of the combination~     therapy. The safety measure will be an assessment of adverse events~   "
237061|NCT00452335|"~     The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a~     pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a~     subset of patients.~   "
237062|NCT00452322|"~     Treatment of male hypogonadism by testosterone substitution has be monitored in terms of~     safety. This study relates to safety of a new long-acting preparation.~   "
237063|NCT00452309|"~     The purpose of this study is to test a correction factor which would allow ankle brachial~     indexes taken in the seated position to accurately predict an ankle brachial index taken in~     the supine position.~   "
237064|NCT00452296|"~     Glucose control has been shown as an important and independent prognostic factor in several~     acute conditions in hospitalized patients, including Acute MI, stroke, cardiac surgery and in~     critical care units.~      Patients with acute exacerbation of COPD (AECOPD)and diabetes treated with insulin had a~     longer in-patient stay and more frequent isolation of Gram negative bacteria from sputum than~     those without diabetes.Hyperglycemia (>11 mmol/l) on admission predicted failure of~     non-invasive ventilation and infectious pulmonary complications in patients admitted to the~     ICU with acute respiratory failure caused by severe AECOPD.~      The primary goal of this study is to test the hypothesis that in AECOPD, tight glycemic~     control during hospital stay will improve outcome of hospitalization.~      The secondary goal of this study is to test new ways in controlling patients in the internal~     medicine ward.~   "
237065|NCT00452283|"~     There is growing evidence that a cause of glaucoma is linked to circulatory problems and poor~     auto-regulation of blood flow to the optic nerve. Pulmonary hypertension (PH)is a disease~     characterized by low oxygen levels in the blood and altered blood circulation. The decrease~     in oxygen delivery to the optic nerve could lead to the loss of nerve fiber layer(NFL)in the~     retina and the resulting visual field compromise. This situation is characteristic of~     glaucoma. The ability to identify NFL thinning early could lead to earlier diagnosis of~     glaucoma and more effective treatment to limit dysfunction from visual field loss.~      We hypothesize that the rate of structural damage to the NFL, a feature of glaucoma, is~     higher in patients with PH than expected in healthy populations lacking this disease.~   "
237066|NCT00452270|"~     The aim of this study is to characterize the time profile of the decongestant properties of~     xylometazoline and to investigate its effect on sleep, general well-being and smell/taste.~   "
237067|NCT00452257|"~     The primary objective of this study is to see if enzastaurin affects the pGSK3 beta level in~     B-cell chronic lymphocytic leukemia (B-CLL) cells.~   "
237147|NCT00451191|"~     This is a double-blind randomized phase II trial to determine whether two different doses of~     BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management~     of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will~     receive either a 100U or 300U dose. Participation will last 1 year.~   "
237068|NCT00452244|"~     The epidermal growth factor receptor (EGFR) is a key regulator of growth, differentiation,~     and survival of epithelial cancers. In a small subset of tumors, the presence of activating~     mutations within the ATP binding site confers increased susceptibility to gefitinib, a potent~     tyrosine kinase inhibitor of EGFR. Agents that can inhibit EGFR function through different~     mechanisms may enhance gefitinib activity in patients lacking these mutations. Mevalonate~     metabolites play significant roles in the function of the EGFR; therefore, mevalonate pathway~     inhibitors may potentiate EGFR-targeted therapies. Targeting HMG-CoA reductase, the~     rate-limiting enzyme of mevalonate pathway, using lovastatin induces a potent apoptosis in a~     variety of tumor types. In an in vitro study, combining gefitinib and lovastatin treatment~     showed synergistic cytotoxic activity through enhanced inhibition of AKT activation by EGF in~     NSCLC and head & neck cancer cell lines. Therefore, the investigators would like to compare~     the combination effect of gefitinib and simvastatin, the specific and protein inhibitor of~     HMG-CoA reductase, with gefitinib alone in previously treated patients with NSCLC.~   "
237069|NCT00452231|"~     The purpose of this study is to investigate if the effectiveness of cognitive-behavioral~     therapy for post-traumatic stress disorder can be increased by combining it with~     D-cycloserine (TCC/D-cycloserine) by comparing with a placebo (TCC/placebo).~   "
237070|NCT00452218|"~     The purpose of this study is to assess the safety and tolerability of sorafenib in patients~     with PAH already on existing therapy with a prostacyclin [epoprostenol (Flolan)],~     treprostinil (Remodulin), or iloprost alone, or with or without sildenafil (Viagra/Revatio).~   "
237071|NCT00452205|"~     The purpose of this study is to clarify the relationship bone marrow-derived cells and the~     formation of the tumors, and the role of these cells in regeneration of epithelial cells in~     the gastrointestinal tract.~   "
237072|NCT00452192|"~     A major complication of diabetes mellitus is diabetic nephropathy. In previous studies the~     investigators could demonstrate that in patients with type 2 diabetes mellitus despite~     unaltered basal and stimulated nitric oxide (NO) - activity, the renal response to the~     antioxidant vitamin C was more pronounced compared to control subjects. These data suggest~     that oxidative stress is increased in the renal vasculature of diabetic patients.~     Furthermore, NO-activity in diabetic patients appears to be up regulated to compensate for~     increase in oxidative stress. This hypothesis is supported by the demonstration of increased~     endothelial nitric oxide synthase (eNOS) expression in kidney biopsies of diabetic patients.~      Angiotensin receptor blockers have been found to reduce oxidative stress in various vascular~     beds. Some drugs of this class, Telmisartan for example, also exhibit partial agonist~     properties to the PPARγ receptor and might be of great benefit for patients with diabetes~     mellitus or metabolic syndrome due to an additional improvement in insulin resistance.~     Despite its effect on oxidative stress angiotensin receptor blockers beneficially alter renal~     haemodynamics by reducing intraglomerular pressure and thus protect against glomerular~     injury.~      Recent advances in magnetic resonance imaging lead to the development of new techniques that~     allow a separate measurement of renal medullar and cortical perfusion. This magnetic~     resonance imaging technique might be a useful tool to detect alterations at an early level in~     the kidneys of patients at high risk for diabetic nephropathy. In the current study, the~     investigators want to evaluate the new magnetic resonance imaging technique by measuring~     medullar and cortical renal perfusion before and after pharmacological intervention with~     telmisartan in patients with metabolic syndrome.~   "
237073|NCT00452179|"~     The purpose of this study is to determine the effects of APD125 in patients with sleep~     maintenance insomnia.~   "
237074|NCT00452166|"~     30 non-diabetic, non-obese patients with stage 4 chronic kidney disease will be asked to~     participate in this metabolic study.~      The primary aim of this study is to determine the effect of rosiglitazone on insulin~     resistance in non-obese patients with non-diabetic stage 4 CKD.~      Secondary end points are the effects on inflammation (hsCRP), lipid profile, bone density and~     body composition.~   "
237075|NCT00452153|"~     The validity of molecular techniques for the diagnosis of legionellosis is not known.~     Although PCR can detect Legionella pneumophila (responsible for 80% of legionellosis) and~     other Legionella species, this test is not recommended in standard guidelines to assess this~     diagnostic, by contrast to culture of sputum, serology and urine antigen. The aim of this~     study is to evaluate Legionella PCR techniques, performed directly onto the sputum aspirates,~     for the routine diagnosis of pneumonia in adults' patients admitted to hospital. This study~     implicates 3 University hospitals (Lyon, Grenoble and Saint-Etienne) in collaboration with~     the French reference center of legionellosis for a previous duration of one year. In addition~     to the usual diagnostic tests that are performed when pneumonia is suspected, real-time PCR~     will be added for the detection and differentiation of Legionella. Hypothesizing the~     inclusion of 1000 pneumonia in this study, the predictable number of newly-detected~     legionellosis will be approximately 60 to 70 cases. According to a predefined algorithm,~     cases of legionellosis will be classified as definite or probable. Sensitivity and~     specificity of the real-time PCR will be calculated according to this classification. This~     study is intended to validate real-time PCR as a tool for the rapid diagnosis of~     legionellosis, allowing to optimize the antibiotic treatment of pneumonia. PCR techniques can~     also contribute to the better detection and differentiation of Legionella sp infections that~     are not documented accurately by routine microbiologic tests.~   "
237076|NCT00452140|"~     The purpose of the study is to demonstrate clinical efficacy of the investigational~     trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or~     2+ (FISH-) expressing advanced or metastatic breast cancer (stage III b/IV) which has~     progressed after endocrine therapy.~      Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu and CD3 on T cells.~     Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new~     antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages,~     dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to~     preclinical data, trifunctional antibodies activate these immune cells, which can trigger a~     complex anti-tumor immune response.~   "
237148|NCT00451178|"~     To compare R-CHOP plus enzastaurin versus R-CHOP for progression-free survival (PFS) time~     measured in patients with intermediate and/or high risk DLBCL receiving first-line treatment.~   "
237294|NCT00449241|"~     To find out how the application of acupuncture needles to the proposed acupuncture points:~     Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during~     Esophago-gastro-duodenoscopy (EGD)~   "
237077|NCT00452127|"~     This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of~     single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL.~     The trial will enroll in two phases: a Phase I dose-escalation portion for patients with~     indolent NHL and a Phase II portion with enrollment of additional patients with follicular~     NHL into two expanded treatment cohorts in order to expand the safety database and collect~     preliminary anti-lymphoma activity data.~   "
237078|NCT00452114|"~     This study is a randomized, controlled trial examining the effectiveness of the mechanical~     cough-assist device (in-exsufflator) in promoting the clearance of retained airway secretions~     in patients with symptomatic bronchiectasis. We hypothesize that this enhanced clearance of~     airway secretions will lead to a decline in the number of acute exacerbations of~     bronchiectasis experienced by these patients during the study period, improve health-related~     quality of life, decrease overall health-care costs and improve pulmonary function.~   "
237079|NCT00452101|"~     The objective of this trial is to evaluate the effect of Aquamin F alone or in combination~     with glucosamine sulfate versus placebo on symptoms of joint pain, stiffness and immobility~     in subjects with painful osteoarthritis of the knee. The following hypotheses were tested:~      (Hypothesis 1) After 12 weeks of treatment, subjects taking Aquamin F alone or in combination~     with glucosamine sulfate will have significantly less joint pain, stiffness and immobility~     compared to subjects taking glucosamine sulfate alone or placebo alone.~      (Hypothesis 2) No significant differences will be seen for adverse events between the~     subjects taking Aquamin F, glucosamine sulfate, Aquamin F + glucosamine sulfate or placebo.~   "
237080|NCT00452088|"~     This will be a study of the safety of MSP 3 LSP candidate malaria vaccine in children aged~     1-2 years in Burkina Faso. Three imminizations at 28 day intervals will be administratered~     subcuteneously on the shoulder region. The study will compare MSP3 with Engerix B vaccine to~     evaluate whether it is just as safe to give to children in malaria endemic country. The study~     will also evaluate whether the vaccine induces the expected immune responses. Two dose levels~     of MSP 3 will be evaluated; 15µg and 30µg to determine the one with the best safety and~     immune response profile.~   "
237081|NCT00452075|"~     A phase II study of Tarceva (Erlotinib) and predictive markers as first-line treatment of~     advanced non-small cell lung cancer for patients unfit for chemotherapy (NSCLC) Clinical~     Phase II Stage IIIB or IV non-small cell lung cancer (NSCLC) Primary end point: Disease~     control rate (= CR+PR and SD at 8 weeks /patients). Secondary end point: Safety (Serious~     Adverse Events, Adverse Events leading to premature withdrawal, unexpected TarcevaTM related~     AEs) .Correlation of EGFR expression rate (HER1) and FISH potentially predictive for~     response.~      An open-label, non randomized, multicenter, clinical trial of TarcevaTM as single agent The~     sample size is 29 patients in 2 stages and based on Simon´s optimal 2 stage design. Stage 1~     will accrue 10 patients, if less than 1 response is observed the study will stop; if more~     than 1 response is observed the accrual will continue up till 29 patients. A total of 29~     patients would be entered and the treatment will be declared to have sufficient activity to~     deserve further attention if at least 5 patients obtain disease control.~   "
237082|NCT00452062|"~     Laryngotracheal injury related to intubation may cause narrowing of the airway due to edema~     of the glottis. Post-extubation airway frequently necessitating re-intubation and resulting~     in the prolongation of intensive care. Factors correlating with the development of~     post-extubation stridor include age, female gender, an elevated Acute Physiologic and Chronic~     Health Evaluation II, trauma related to endotracheal intubation, excessive ETT size,~     unnecessary tube mobility, increased cuff pressure, frequent tracheal aspirations, infection,~     arterial hypotension, and a prolonged intubation period. Because the presence of an~     endotracheal tube (ETT) precludes direct visualization of the upper airway, recognition of~     edema due to laryngotracheal injury is often difficult. However, upper airway patency may be~     measured indirectly in the intubated patient by documentation of a leak around the ETT upon~     deflation of the sealing balloon cuff encircling the ETT. Controversy currently exists~     regarding the effectiveness of prophylactic steroid therapy for patients considered at high~     risk for post-extubation stridor. Only a limited number of prospective trials involving~     adults and evaluating the benefits of corticosteroid therapy prior to extubation have been~     conducted.~      Studies regarding the efficacy of prophylactic corticosteroids for intubated patients have~     yielded conflicting results due to differences in the number of doses or types of~     corticosteroids administered.~      The present study was conducted to evaluate the effects of prophylactic dexamethasone therapy~     for a subset of high-risk patients who had been intubated for > 48 hours and who were~     undergoing their first elective extubation in an ICU setting. The specific objectives were to~     determine whether multiple doses of dexamethasone are effective in the reduction or~     prevention of post-extubation airway obstruction in patients with a cuff leak volume (CLV) <~     110 mL and to ascertain whether an aftereffect follows the discontinuation of dexamethasone.~   "
237083|NCT00452049|"~     Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure.~     Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis~     of renal bone disease, but also in the development of cardiovascular risk factors such as~     disturbed lipid metabolism, glucose intolerance, and hypertension. HPT is also known to play~     an important role in the development of structural abnormalities of both large arteries and~     the heart (left ventricular hypertrophy, interstitial fibrosis). In the last couple of years~     there has been increasing evidence from animal studies that the endothelium is a target organ~     of PTH.~      Hypothesis: PTH has clinically relevant effects on renal hemodynamics, renal function and~     endothelial function.~      Aims:~        1. To evaluate the effect of parathyroidectomy (PTX) on renal hemodynamics in stable renal~          transplant recipients~        2. To evaluate the effect of PTX on endothelial function in stable renal transplant~          recipients/chronic kidney disease (CKD) stage 5 patients~        3. To evaluate the effect of PTX on blood pressure in stable renal transplant~          recipients/CKD stage 5 patients~   "
237084|NCT00452036|"~     The objective of this prospective study is to evaluate the reliability of plain x-rays~     vs.cranial computed tomography as a screening method for skull fractures and its prognostic~     value for intracranial bleeding (ICB).~   "
237085|NCT00452023|"~     The goal of this clinical research study is to see if Pegasys (IFN-alpha2a) can help to~     control the disease in patients with ET, PV, AMM/MF, and Ph-negative CML. The safety of this~     treatment will also be studied.~   "
237086|NCT00452010|"~     Prior studies showed contradictory results about the best type of TENS in chronic pain~     pathology.~      Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low~     back pain or chronic lumbo-radiculalgia.~      The functional ability score is evaluated by the Roland scale at 6 weeks.~   "
237087|NCT00451997|"~     The goal of this clinical research study is to learn if the combination of Gleevec (imatinib~     mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing~     fewer side effects than standard high dose chemotherapy.~   "
237089|NCT00451971|"~     Primary Objectives~        1. To test the feasibility, in patients with active rheumatoid arthritis, of using an~          'aggressive' treatment algorithm to bring a short term treatment objective (STO) within~          the normal or an arbitrarily defined 'desirable' range.~        2. To determine whether patients with active rheumatoid arthritis randomly allocated to a~          particular STO show a reduced rate of Magnetic resonance imaging damage progression at~          two years compared to those randomly allocated to usual care.~      Secondary Objectives~        1. To establish the relationship between achieving a given STO or combination of STOs and~          damage progression.~        2. To identify the characteristics of responders and non-responders with respect to STO~          achievement and predictors of greater and lesser degrees of damage progression.~   "
237090|NCT00451958|"~     Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486~     CS21A study. The study continued until all non-discontinued participants had received~     treatment for at least 5 years.~   "
237091|NCT00451945|"~     The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the~     staging of cervical cancer.~        1. 3-D-ultrasound of the tumour to estimate its volume and local spread~        2. Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes.~   "
237092|NCT00451932|"~     A proof of concept study to evaluate the safety and effectiveness of FK778 in liver~     transplant patients.~   "
237093|NCT00451919|"~     Sickle cell disease is an inherited blood disorder that affects red blood cells (RBCs).~     People with sickle cell disease frequently experience anemia, or a low number of RBCs. RBCs~     are responsible for carrying oxygen to the brain and other body tissues that need oxygen to~     function properly. The purpose of this study is to determine what changes, which were~     possibly caused by anemia, exist in the brains of individuals with sickle cell disease.~   "
237094|NCT00451906|"~     This single arm study will assess the safety and efficacy of Avastin combined with~     platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous~     non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in~     combination with platinum-based chemotherapy or in combination with any standard of care~     NSCLC first-line chemotherapy used in line with the licensed national prescribing~     information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week~     cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of~     chemotherapy cycles until disease progression, and the target sample size is 500+~     individuals.~   "
237095|NCT00451893|"~     The trial compares the postoperative complain, pain, quality of life after the implantation~     of a heavy-weight alternative light-weight mesh, by randomly allocating patients with~     inguinal hernia disease to two groups of surgeons, each group being trained to operate with~     one of the above mentioned meshes.~      Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.~   "
237096|NCT00451880|"~     The purpose of this study is to determine the safest dose of the multiple Raf kinase~     inhibitor (including c-Raf, B-Raf, and the activated mutant B-RafV600E) XL281, how often it~     should be taken, and how well subjects with cancer tolerate XL281. This study will also~     determine how the body reacts to XL281 when it is taken with and without food, and with and~     without Pepcid (famotidine), a drug that inhibits stomach acid production.~   "
237097|NCT00451867|"~     The purpose of this study is to investigate the safety and effectiveness of a medication~     called CellCept in treating refractory (has not responded to other treatments) interstitial~     cystitis.~      CellCept belongs to a class of medications called immuno-suppressants. Immuno-suppressants~     work in the body by reducing the immune system's ability to produce certain reactions that~     can cause inflammation. In some people, the inflammation produced by their immune system can~     damage healthy tissues and cause symptoms of pain and discomfort. CellCept is approved by the~     U.S. Food and Drug Administration (FDA) for use in patients who have had an organ transplant.~     When used in combination with other drugs, CellCept helps to prevent the rejection of the~     transplanted organ and is used widely in patients who have received kidney, liver and heart~     transplants. CellCept is also frequently used but not FDA approved for the treatment of~     severe rheumatoid arthritis which is a disease caused when the body's immune system acts~     against healthy tissues in the joints.~      Due to its special activity, CellCept may be useful in treating certain inflammatory diseases~     or conditions like interstitial cystitis.~   "
237098|NCT00451854|"~     The purpose of this study is to determine the influence of drug testing on risk and~     protective factors of substance abuse among adolescents; examine whether drug and alcohol~     testing among high school athletes leads to reduced drug and alcohol use; and assess the use~     of drugs and alcohol among student athletes and non-athletes.~   "
237099|NCT00451841|"~     Cough is the most common complaint for which patients seek medical attention in the United~     States, accounting for approximately 1 billion dollars in health care expenses annually.~     Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of~     all cases. The majority of these patients with GERD-induced cough have no classic heartburn~     symptoms, so this important cause of cough can thus be difficult to detect.~      Our hypothesis is that changes in exhaled breath condensate (EBC) pH can be used as a~     sensitive and non-invasive marker to identify subjects with cough caused by acid reflux.~   "
237100|NCT00451828|"~     The overall objective of the CAP study was to determine genetic influences on efficacy of~     simvastatin treatment with regard to LDL cholesterol reduction and changes in other markers~     of cardiovascular disease risk.~   "
237101|NCT00451815|"~     To assess the preliminary safety and tolerability of multiple oral doses of BIIB014 in~     subjects with early PD.~   "
237113|NCT00451646|"~     The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison~     to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral~     nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and~     coagulation variables, vital signs and adverse events. Further objectives to evaluate are the~     influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative~     properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red~     blood cells and serum.~   "
237149|NCT00451165|"~     Research Populations: Male patients scheduled for laparoscopic colorectal surgery~      Study Method: Questionnaire and function tests~      Hypothesis: A laparoscopic nerve-sparing operation is not inferior to reported open surgery~     in preserving urinary and sexual function.~   "
237102|NCT00451802|"~     Biomedical and biotechnology industry is internationally regarded as the most brilliant star~     performer of the future. The development of biomedical depends on a high quality academic~     research environment, while innovation and uniqueness should be emphasized for the~     development of biotechnology industry. The successful development of biotechnology industry~     will be impossible if the development is not based on extensive and in-depth research work~     and verification acquired from clinical implementation. Based on these concepts, the~     resources of research materials, especial of human being, are going to be essential. Thus, a~     programmable and systematic collection of clinical specimen would become one of the potential~     properties in hospital. This is a two-year pilot scheme, and was designed to start collecting~     specimen from “Health Management Center” in NTUH. This pilot scheme will address important~     issues of manpower, finances, and data merging for evaluation of biotechnological related~     specimen collection, such as cell or tissue bank, in the future.~   "
237103|NCT00451789|"~     Introduction and Aims:~      The objective of this prospective study is to evaluate the risk factors of minor head injury~     in all consecutive patients of one year.~   "
237104|NCT00451776|"~     Because of its hemodynamic safety, etomidate is widely used for anaesthesia induction of~     cardiac surgery. It can also cause adrenal insufficiency during the following 48 hours ( 11~     betahydroxylase inhibition ). So it could increase hemodynamic dysfunction caused by the SIRS~     following cardiopulmonary bypass.~      A previous observational study found more adrenal insufficiency and need for vasopressive~     support therapy in the etomidate group versus another propofol induced group.~      The aim of our work is to compare hemodynamic dysfunction following induction with etomidate~     for cardiac surgery with ECC. The control group would be induced by Propofol. 94 patients~     would be included.~   "
237105|NCT00451763|"~     Idiopathic Macular Telangiectasia is characterized by incompetent and dilated retinal~     capillaries in the foveolar region of unknown cause for retinal telangiectasia.~      In Idiopathic Macular Telangiectasia, proliferative changes occur in the deep retinal~     capillary network, leading to intraretinal neovascularization that, unlike in age-related~     macular degeneration, seems to be retinal rather than choroidal in origin. Before the~     hemorrhagic and fibrotic state, these vessels may lead to exudation and decrease in the~     visual acuity. Long-term visual prognosis in patients with this complication may be poor and~     treatment with laser photocoagulation is unproven. Although newly reported treatment, by~     photodynamic therapy for neovascular membrane associated with Idiopathic Macular~     Telangiectasia, may show vision and angiographic stability in a few cases, the improvement~     may be transient. VEGF has been implicated as the major angiogenic stimulus responsible for~     neovascularization in AMD, ensuing specific anti-VEGF treatment in these cases.~      The purpose of the study is to evaluate intravitreal injection of bevacizumab (1.25mg/0.05ml)~     in the treatment of Idiopathic Macular Telangiectasia.~   "
237106|NCT00451750|"~     The aim of this prospective, double-blind, placebo-controlled, randomized study is to~     investigate if glucocorticoid treatment, in combination with exposure therapy, helps to~     reduce phobic fear in patients with phobia.~   "
237107|NCT00451737|"~     The six-minute walk test had been used to assessment the cardiopulmonary parameter in~     patients with lung and heart disease. And it has good reliability and validity. It has been~     used extensively in research into the aerobic capacity in patients of peripheral vascular~     disease, neural system disease, and even the muscular-skeletal system disease, such as~     osteoarthritis, total hip or knee arthroplasty. There were studies investigate the predictors~     based on cardiopulmonary factors, neuromuscular and skeletal factors of the six-minute walk~     distance. But the last is the neuromuscular and skeletal factors.~      The purpose of this study is to investigate the correlations between the six-minute walk~     distance and neuromuscular parameters: muscle function (including muscle endurance, muscle~     strength and muscle power), knee proprioception, and standing balance. For that it could be~     more useful for evaluation and treatment patients in clinic.~      The study was planed to select 100 subjects, they are older than 65 years old with~     independent walking and without any diagnosis or symptoms about cardiopulmonary or neural~     disease. The evaluation are including knee proprioception (closed chain, active-active test),~     six-minute walk test, one leg standing balance test (open and close eyes for 30 seconds),~     quadriceps muscle strength at velocities of 600/s,1200/s and 1800/s, quadriceps muscle power~     at 1800/s, and quadriceps muscle endurance.~      To investigate the correlations between the six-minute walk distance and characteristics of~     subjects, the correlations between six-minute walk distance and neuromuscular parameters,~     including quadriceps muscle function (strength, endurance and power), knee proprioception,~     and one leg standing balance. And to analyze what’s the most contribution to the six-minute~     walk distance.~   "
237108|NCT00451724|"~     The purpose of this study is to compare how well three different doses of ketamine, given as~     a spray into the nose, help to sedate children and help them tolerate repairs of cuts on~     their faces.~   "
237109|NCT00451711|"~     The purpose of this trial is to see which dose of liposomal amphotericin B is the safest when~     used as a preventer against invasive fungal infection in patients with acute leukaemia who~     are undergoing chemotherapy.~   "
237110|NCT00451698|"~     Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can~     cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to~     the heart bypass portion of surgery may protect the infant human heart and brain from injury.~      This randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring~     heart bypass surgery for congenital heart defects.~   "
237111|NCT00451672|"~     we propose that bromocriptine may be an alternative treatment of primary aldosteronism, both~     APA and BAH.~   "
237112|NCT00451659|"~     This study is a retrospective chart review of recently deployed veterans who served during~     the Iraq conflicts and were seen at the TVAMC in the outpatient Primary Care outpatient~     clinic that was recently set-up for newly returning veterans since its inception through July~     1, 2005. Identical data will be collected on non-combat veterans that were seen in other~     primary care clinics at the Tuscaloosa VA Medical Center during June 2004 and July 1, 2005.~     This information will be used for comparison with the Iraqi veterans group. The data will be~     retrieved from a computerized list of these patients. Charts will then be examined to~     determine sociodemographic, medical, psychiatric, and health care utilization~     characteristics.~   "
237114|NCT00451633|"~     A randomized, double blind, placebo-controlled study employing a mixed parallel group and~     fixed sequence cross-over design.~      Patients will be randomized to one of two treatment groups ('E2007' or 'Placebo') in a 1:1~     ratio and receive investigational drug treatment concomitant with their standard~     individualized anti-Parkinsonian therapy for a total of six weeks. Investigational drug~     treatment for patients in the E2007 treatment group will be started 2 mg E2007 o.d. but will~     be escalated to 4 mg E2007 o.d. after three weeks.~   "
237115|NCT00451620|"~     The results from the DECODE Study have shown that postprandial (1 - 2 hours after a meal)~     hyperglycemia (elevated blood sugar) is more common in elderly people with diabetes than~     younger people with diabetes and is the best predictor of the development of complications.~     The DECODE Study involved 6941 people who already had diabetes and 702 who did not have~     diabetes. Diabetes is diagnosed when the blood sugar 1st thing in the morning is over 7.0~     mmol/L. The DECODE Study showed that people at risk for diabetes can have a normal blood~     sugar 1st thing in the morning but have a high blood sugar 2 hours after a meal and that~     these people are at risk for developing heart disease and other complications of diabetes.~     These people would not be identified as at risk if only a fasting blood sugar is done.~     Studies in younger people with diabetes have shown that after a meal, insulin levels are more~     like a person without diabetes and glucose (blood sugar) levels are lower with GlucoNorm than~     with Glyburide. There is no data available that demonstrates this in elderly people with type~     2 diabetes.~      You have been invited to participate in this study because you have type 2 diabetes~     controlled by diet and/or exercise or metformin only and are over 65 years of age.~      The purpose of this study is to determine whether GlucoNorm has a greater effect than~     Glyburide on insulin levels and glucose (blood sugar) levels after a meal in elderly people~     with type 2 diabetes who control their diabetes with diet and exercise.~   "
237116|NCT00451607|"~     Autonomic nervous system (ANS) is an essential regulator for the homeostasis, circulatory and~     respiratory systems. Heart rate variability, under the dependence of the parasympathetic and~     orthosympathetic arms is a peripheral witness of its well functioning.~      Activity ANS indices are technically measurable from the birth by non invasive cardiac~     monitoring: in given environmental conditions. According to the individualized care given to~     the baby, we can easily observe by frequential analysis, modifications of ANS level activity;~     If for a full-term newborn, the balance of ANS allows him to adapt its cardiac frequency to~     its internal and external environment (thermoregulation, baroreflex, sinus arrhythmia,~     awakening state) , the premature birth is at the origin of a prolonged defect of global ANS~     maturation, probably induced by external environmental and stress factors (pain,~     stimulations, aggressive noise and lights). This disrupted maturation profile in case of~     prematurity, was confirmed in two preliminary studies on premature babies reaching term for~     gestational age.~      We hypothesis that adapted sensorimotor care could decrease this stress and optimize the ANS~     activity profile.~      In a prospective study, by a non invasive real-time measure, we analyse impact of stress on~     ANS activity in a premature population, hospitalized in our neonatal intensive care units.~   "
237117|NCT00451594|"~     To determine the long term effects of pulse high dose dexamethasone and conventional dose~     prednisolone in treatment of adult patients with ITP.~   "
237118|NCT00451581|"~     Endoscopic papillary balloon dilation is as effective as sphincterotomy in treating bile duct~     stone. However, a need to switch to sphincterotomy is noted in about 20% of cases receiving~     dilation for lithotripsy. It is hypothesized that a longer dilation duration (5 min. vs. 1~     min.) can decrease the need of switching to sphincterotomy.~   "
237119|NCT00451568|"~     Background: PCOS is a common condition with a prevalence of 5-8 % in premenopausal women.~     More than 50% of PCOS patients are insulin resistant and have a diabetes risk 5-8 times~     higher than age- and weight-matched controls. Studies using insulin sensitizers in PCOS found~     increased insulin sensitivity and decreased insulin levels to be followed by decreased~     androgen levels and improved ovulatory function. No studies however, evaluated the long term~     effects of insulin sensitizing treatment.~      Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS, however~     no long-term studies evaluated the effects of combined treatment with metformin and oral~     contraceptives in PCOS.~      Design: Randomized open study in 3*30 PCOS patients. Patients are randomised to 24 months of~     treatment with 1: metformin, 2: metformin and oral contraceptives or 3: oral contraceptives.~      Primary outcome measures: fasting insulin, AUC insulin. Secundary endpoints: BMI, WHR, LH,~     FSH, total and free-testosterone, c-peptid, urinary cortisol, AUC for insulin, glucose and~     c-peptid during OGTT.~      Inclusioncriteria:~        1. Irregular menses or anovulaty cycles~        2. High free testosterone > 0,035 nmol/l or hirsutism~        3. PCO in vaginal US Criteria 1 and 2 OR 2 and 3.~      Design:~   "
237120|NCT00451555|"~     The primary purpose of this study is to help answer the following research question: whether~     enzastaurin given together with fulvestrant can help patients who have breast cancer and make~     the tumor smaller or disappear and for how long.~   "
237121|NCT00451542|"~     This study is a retrospective chart review of patients treated for bipolar disorder at the~     TVAMC in the past four years cross-referenced with the electronic pharmacy file for having~     received a prescription of divalproex or lamotrigine.~   "
237122|NCT00451529|"~     Patients with a moderate to severe carotid atherosclerotic plaque are at risk for stroke and~     this risk increases with increasing degree of stenosis. It has been shown that carotid~     endarterectomy in symptomatic patients with a carotid artery stenosis of 70-99% is highly~     beneficial. However, the beneficial effect of surgery in patients with symptomatic 30-69%~     stenosis is not clear yet.A clear beneficial effect of surgery in the 30-69% stenosis group~     might be found in a sub-group of patients whom are at greater risk for stroke. Definition of~     this sub-group might be achieved by plaque characterization, since rupture of a vulnerable~     plaque is the main cause of stroke due to carotid artery stenosis.This study will include~     patients with a 30-69% carotid artery stenosis, and assess plaque composition by MRI, the~     degree of plaque inflammation by FDG-PET, and the amount of microembolization by transcranial~     Doppler ultrasound. The main purpose of this study is to assess whether one or a combination~     of each of these imaging methods can predict the occurrence of a (recurrent) ischemic stroke.~   "
237145|NCT00451217|"~     The purpose of this study was to demonstrate in adult patients faster recovery from a~     neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance~     of T2 by 2.0 mg/kg Org 25969 (sugammadex) compared to 50 ug/kg neostigmine.~   "
237123|NCT00451516|"~     SJW has the greatest evidence of herbal medicine efficacy in treating MDD. In treating~     anxiety, kava has the greatest evidence of efficacy. As comorbidity of MDD and anxiety~     commonly occurs, it is conceivable that a combination of an established antidepressant agent~     such as SJW and an established anxiolytic agent such as kava may effectively treat MDD~     presenting with comorbid anxiety. It is possible that a beneficial synergistic effect may~     also occur between SJW and kava, improving the treatment outcomes in MDD with comorbid~     anxiety, than by the individual substances alone. Determination of this is not addressed in~     this study due to limitations of time and resources. The determination of the strength of the~     SJW-kava combination will be ascertained by comparing similar trials using SJW and kava~     mono-therapy in addressing MDD and GAD.~      The hypothesis is that a combination of SJW and kava will reduce MDD occurring with comorbid~     anxiety more than placebo.~   "
237124|NCT00451503|"~     The middle ear implant are used for patients with mild to severe sensorineural hearing loss,~     who cannot benefit from conventional hearing aids because of medical reasons such as chronic~     external otitis or external skin irritation. The device is also available for patients who~     are dissatisfied with the conventional hearing aids because of poor sound quality, feedback~     or occlusion of the ear canal. To date, more than 1500 patients have been implanted in Europe~     and about more than 600 patients in France. The aim of the present study is to compare in a~     randomized study the performances of the system to those of the conventional hearing aid in~     patients with similar degree of hearing loss.~   "
237125|NCT00451490|"~     Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both~     agomelatine and floxentine will increase HRV at the end of the treatment.~   "
237126|NCT00451464|"~     Cardiovascular-related diseases have been the majorities of the leading ten causes of death~     in Taiwan. Atherosclerotic cardiovascular diseases are multifactorial. Some non-modifiable~     risk factors (e.g. genetic trait) may attenuate the benefit of risk modification of the~     modifiable factors (e.g. the effect of drug treatment). Genetic epidemiology has being widely~     used to analyze the underline risk of cardiovascular diseases and to point the direction of~     treatment or prevention.~      Lipoprotein is composed of lipid and protein. The genetic variation or mutation of~     apolipoprotein, the protein of lipoprotein, has been linked to some lipid abnormality~     resulting severe atherosclerotic cardiovascular diseases. ApoA-I, apo A-II, apo A-IV, apo~     B100, apo B48, apo C-I, apo C-II, apo C-III, apo D, and apo E are currently thought to affect~     lipid abnormalities. In addition, it has been documented that genetic variations are~     presented among different races. Apolipoprotein genetic variations or genetic polymorphism~     study has been emerged as an important role in the field of genetic therapy. The purpose of~     this 3-year study is to continue the lipid study in our laboratory, identifying the~     apolipoprotein genotyping in our pooled hyperlipidemic patients and normal control subjects~     living in Taiwan. We will observe the incidence and link apo A-I, apo A-II, apo A-IV and apo~     C-III genetic variations to the related lipid abnormality and cardiovascular diseases. The~     changes of genotyping after lipid lowering drug treatment using statin or fibrate in~     hypercholesterolemic or hypertriglyceridemic patients is another goal of this project.~   "
237127|NCT00451451|"~     To determine if treatment with BG00012 can decrease the number of MS relapses during a~     certain time period. Other goals of the study are to determine if, over time, BG00012~     treatment can decrease the number of certain types of brain lesions commonly seen in MS~     patients and slow down the time it takes for MS to get worse.~      Other objectives of the study are to determine the safety and tolerability of BG00012, as~     well as the effect it may have on tests and evaluations used to assess MS. Additionally,~     glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.~   "
237128|NCT00451438|"~     The purpose of this study is to investigate the muscle activity of gluteus medius and tensor~     fascia lata in health control group and patients with PFPS during submaximal isometric muscle~     contraction.The research question :Is there any difference of muscle activity of gluteus~     medius and tensor fascia lata between health control group and patients with PFPS during~     submaximal isometric muscle contraction ？Null hypothesis:There is no difference of muscle~     activity of gluteus medius and tensor fascia lata between health control group and patients~     with PFPS during submaximal isometric muscle contraction.~   "
237129|NCT00451425|"~     Excessive weight gain during pregnancy is associated with complications during delivery~     primarily due to macrosomia (large babies) but also with high levels of weight retention post~     pregnancy and thereby increased risk of future weight related health problems. The primary~     aim of this study is to evaluate the efficacy of an intervention consisting of; recurrent~     Motivational Interviewing (MI), prescription of physical activity and extended information on~     recommended weight gain during pregnancy in regards to preventing excessive gestational~     weight gain.~   "
237130|NCT00451412|"~     This study is designed to provide efficacy and safety data for certoparin in the prophylaxis~     of venous thromboembolism in immobilized, acutely ill medical patients.~   "
237131|NCT00451399|"~     Lifestyle intervention and certain medications have been shown to be effective for~     antipsychotic-induced weight gain, but no controlled studies have compared psychological and~     pharmacological therapies. We conducted a randomized, placebo-controlled study to test the~     efficacy of lifestyle intervention and metformin alone and in combination for~     antipsychotic-induced weight gain.~   "
237132|NCT00451386|"~     This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in~     pediatric patients with urinary tract infections, skin infections, or community-acquired~     pneumonia.~   "
237133|NCT00451373|"~     We examine the prognosis and etiology of postoperative acute renal failure~   "
237134|NCT00451360|"~     We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical~     trial in patients with hip osteoarthritis in order to:~        -  evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive~          decrease in joint space width observed in patients with hip osteoarthritis~        -  to investigate the potential structure-modifying effect of diacerein in patients with~          hip osteoarthritis~      This study compare also after ten years the percentage of patients in each treatment group~     who require a hip replacement surgery~   "
237146|NCT00451204|"~     This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in~     relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone~     injections in all subjects. The primary outcome measure is a reduction in relapses.~   "
237135|NCT00451347|"~     Objectives:The purpose of this study was to investigate the different effects among the~     quadriceps strength training, taping, and stretching exercise of iliotibial band in patients~     with patellofemoral pain syndrome by randomized control trial study.~      Method:An observer blind, prospective, factorial design randomized controlled trail. 90 young~     adults with patellofemoral pain syndrome were randomly allocated into one of three treatment~     groups: (1) Quadriceps strength training, (2) taping, and (3) stretch. Each group received~     treatment for 8 weeks.~      Hypothesis:Patients in quadriceps strength training group may get most outcomes in three~     groups~   "
237136|NCT00451334|"~     This study is a prospective, open label, controlled, single center study. 40 patients will be~     recruited for the study, according to patients’ inflow and meeting eligibility criteria.~      Primary Goal~      * To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level~     measurement technology.~      Secondary Goal~      * To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level~     measurement technology.~   "
237137|NCT00451321|"~     The purpose of this study is to optimize several multi-dose regimens of otelixizumab,~     determine the highest biologically active dose, evaluate biomarkers and surrogates of~     efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against~     standard safety and efficacy parameters.~   "
237138|NCT00451308|"~     The rate of labor induction is rising throughout the United States for a variety of reasons.~     Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and~     fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley~     balloon catheter placement is a common method used for labor induction in women with an~     unfavorable cervical assessment. There are several studies using various volumes of Foley~     balloon catheters for labor induction ranging from 30ml to 80ml, however, there are no~     studies replicating the findings of the largest study comparing 2 different volumes in the~     balloon. The investigators plan to compare instillation of 30ml of sterile saline versus 60ml~     in a Foley balloon catheter for women undergoing induction of labor with an unfavorable~     cervix. The investigators will observe the following outcomes: rate of delivery within 24~     hours, cervical dilation after foley balloon catheter expulsion, insertion to balloon~     expulsion interval, induction to delivery time interval, peak oxytocin requirement, presence~     of infection or meconium, cesarean delivery rate, operative vaginal delivery rate, indication~     for operative vaginal or cesarean delivery, cervical laceration rate, placental abruption~     rate, 5-minute Apgar score, and umbilical cord arterial blood pH and base excess.~   "
237139|NCT00451295|"~     This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks~     treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the~     treatment period, MCI-196 or placebo will be titrated every 3 weeks.~   "
237140|NCT00451282|"~     This study will evaluate the impact of a brief psychosocial intervention delivered to~     children or adolescents who are hospitalized for an unintentional injury. The intervention is~     designed to promote psychological recovery and enhance functional outcomes after injury. The~     study will also provide preliminary data concerning cost-effectiveness of the intervention.~      The core study hypotheses are that children receiving the intervention will (1) have lower~     severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2)~     show greater adherence to discharge instructions and better health-related quality of life at~     follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and~     lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury,~     compared to those receiving usual care.~   "
237141|NCT00451269|"~     The annual number of cases of clinical malaria worldwide is estimated to be 300-500 million~     leading to 1.5 million deaths. Delayed care and frequent drug resistance of Plasmodium~     falciparum (Pf), the most frequent form of malaria, is responsible for these deaths. Each~     year, 5000-8000 travellers return to France with malaria, 4/5 from Africa and with Pf.~     Clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can~     be easily made. Diagnosis of accurate malaria rely on microscopic examination of stained thin~     and thick blood films by a well trained microscopist. Few emergency wards are specialized for~     tropical diseases. For most of them, malaria is a rare disease and hours are lost before~     accurate microscopy can permit the decision~   "
237142|NCT00451256|"~     For some people who have heart by-pass surgery, the vein that is used to by-pass a blockage~     will, after some time, become narrowed and possibly blocked. AVI-5126 blocks a gene that is~     believed to be responsible for the events in the blood vessel that cause this narrowing.~     Therefore, exposing the vein to AVI-5126 before it is attached to the coronary artery may~     result in less problems with these vein grafts later on. This study will determine if this~     procedure is both safe and effective.~   "
237143|NCT00451243|"~     Psoriasis is a multifactorial cutaneous disorders which affects about 100000 patients in~     Taiwan. Psoriatic arthritis is also present in about 20~30 percents. Many drugs have been~     shown to aggravate psoriasis including drugs used in the treatment of psoriatic arthritis. On~     the contrary, anti-psoriatic drugs are also known to aggravate or induce psoriatic arthritis.~     Psoriasis and psoriatic arthritis are believed to share the same pathogenic lymphocytes, but~     the differential responses to drugs are intriguing. This also causes problems in the~     treatment of psoriasis and psoriatic arthritis. Recently different serologic markers have~     been found for the assessment of psoriasis and psoriatic arthritis. Recent genetic study~     showed a different genetic susceptibility genes. We tested the serologic responses of three~     new biologic drugs used in the treatment of psoriasis and psoriatic arthritis. Paired blood~     samples of the same patients before and after 12 weeks of treatment were used. IL6 decreased~     after alefacept and etanercept but was increased after efalizumab treatment without~     statistical significance (Paired t test: 0.3336、0.2773、0.5904)。IL-8 decreased after~     etanercept but increased after efalizumab and alefacept without statistical significance~     (Paired t test: 0.4031、0.6749、0.2998)。IL10 decreased after efalizumab and etanercept, but~     increased significantly after alefacept treatment (Paired t test: 0.7254、0.5123、0.0350)。None~     of the treatment has a significant effect on TNF-alpha. HC10 decreased after alefacept and~     efalizumab,but increased after etanercept treatmentwithout statistical significance (Paired t~     test: 0.6589、0.1576、0.1988).~   "
237144|NCT00451230|"~     The goal of this this study is to elucidate the role of the HPA axis in the pathophysiology~     of cocaine dependence~   "
237152|NCT00451126|"~     With the aim of evaluating the putative impacts of emotion related personality factors on~     physical and mental disease and the mechanisms of these impacts, 58 students were submitted~     to a social stress test (Trier Social Stress Test) and salivary cortisol samples were taken.~     The subjects were also submitted to several personality trait inventory, that evaluated~     respectively Alexithymia, Emotional Intelligence, Resilience and the Five Factor Model of~     Personality.~      The moderating impact of these factors on the cortisol response were analysed~   "
237153|NCT00451113|"~     Diabetes is common in the elderly; by the age of 70, approximately 25% of the population will~     have diabetes. Unfortunately, currently available medications are often not as effective or~     not well tolerated in older adults. Sitagliptin is a new medication in a new class of agent~     called incretins. Incretins have many potential advantages for the treatment of diabetes in~     the elderly. They stimulate insulin secretion, which is impaired in all older people with~     diabetes. The incidence of hypoglycemia with currently available medications increases with~     age, and incretins rarely cause hypoglycemia . They assist with weight loss, whereas many~     current medications used to manage diabetes result in weight gain in the elderly. They~     improve insulin action, and insulin resistance is a major problem in older people with~     diabetes.~   "
237154|NCT00451100|"~     The purpose of this study was to demonstrate in adult patients a faster recovery from a~     neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50~     ug/kg neostigmine after cisatracurium when administered at reappearance of T2~   "
237155|NCT00451087|"~     We assume the etiology of patellofemoral pain syndrome is related to mechanical properties of~     tendon structures of the vastus medialis obliquus and vastus lateralis. Consequently, we will~     measure the electromechanical delay and some viscoelastic parameters of the two muscles.~     Besides, we will also investigate the effects of exercise training to the mechanical~     properties of the muscles.~   "
237156|NCT00451074|"~     The purpose of this study is to determine the safety of giving intravenous (IV) gentamicin to~     boys with Duchenne muscular dystrophy who have stop codon mutations.~   "
237157|NCT00451061|"~     Most of the patients suffering from renal colic have a distal ureterolithiasis. It had been~     demonstrated that α adrenoreceptors antagonists, given to patients suffering from renal~     colic, due to distal ureterolithiasis, had increased the frequency of stone expulsion rate ,~     reduced the time to expulsion and reduced analgesics consumption.Most of the studies~     evaluated the efficacy of Tamsulosin, which is a selective α 1A and α 1D adrenoreceptors~     antagonist.(The lower intramural portion of the ureter, where it passes through the detrusor~     muscle contains mostly α 1D and α 1A adrenergic receptors)~      Only one study these days describes the use of Alfuzosin, which is an α adrenergic receptor~     blocker and not selective for any α 1 adrenergic receptor, for expulsion of distal ureteric~     stones.Alfuzosin is a drug with a proven efficacy and considered uroselective with high~     specificity and sensitivity, for the treatment of BPH. There was no significant difference in~     efficacy between the two α blockers (Alfuzosin vs. Tamsulosin) concerning symptoms relief or~     flow improvement.~      The objective of this study is to compare patient who would receive the standard treatment~     for distal ureterolithiasis (analgesics, Rowatinex) to patients who would receive also a non~     selective α blocker (Alfuzosin) or a selective α blocker (Tamsulosin). This in order to~     evaluate the efficacy of treatment with α blockers for expulsion of distal ureterolithiasis.~   "
237158|NCT00451048|"~     This phase II trial is studying how well sunitinib works in treating patients with~     myelodysplastic syndromes or chronic myelomonocytic leukemia. Sunitinib may stop the growth~     of abnormal cells by blocking some of the enzymes needed for cell growth.~   "
237159|NCT00451035|"~     This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic~     phase chronic myeloid leukemia with resistant disease following treatment with at least two~     BCR-ABL tyrosine kinase inhibitors~   "
237160|NCT00451022|"~     This study aims to provide long-term follow-up care of patients previously enrolled in a~     vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that~     can be used to introduce specific genes into genetic makeup. The study does not involve the~     use of any drug or biologic agent. Participants will undergo an annual health history.~     Because certain viruses enter into cells and create proteins from the viral genes, the type~     of vaccine treatment used is referred to gene therapy. The genes expressed by poxviral~     vectors do not become part of the genetic material left behind. Because gene therapy is a~     somewhat new technology, a prolonged monitoring of patients' health status is necessary,~     according to new specific reporting requirements for harmful events in patients who undergo~     such gene therapy studies. The risk of any long-term negative effects from the gene therapy~     that patients had received is quite small. Still, it is important that there be updates at~     least annually. This annual monitoring of health status will extend for 15 years, according~     to guidelines from the Food and Drug Administration, or for as long as patients are willing~     to participate.~      Patients who received poxviral vectors (vaccinia or fowlpox, or both) at the National Cancer~     Institute, through a trial affiliated with the Laboratory of Tumor Immunology and Biology,~     may be eligible for this study.~      Participants will be involved in the following forms of data collection:~        -  Annual medical history and physical examinations for the first 5 years following the~          last vaccine.~        -  Annual telephone contact during the last 10 years.~        -  Health status check, including primary cancer status, secondary malignancies, neurologic~          disorders, autoimmune disorders, and hematologic disorders.~        -  Blood tests for the presence of HIV antibodies.~        -  Reporting of medical problems, including information on unexpected hospitalizations and~          medications.~      If a participant has died, the study will document the cause of death and autopsy information~     if available.~   "
237161|NCT00451009|"~     The purpose of this study is to determine the effectiveness of the ViaCell's product media~     for freezing and thawing human eggs for future use in assisted reproductive technology.~   "
237162|NCT00450996|"~     PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of~     endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN:~     Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes~     (age: 52 >= 19 years; follow-up: 42 >= 18months). METHODS: Postoperative treatment started~     with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6~     months. Patients were then randomised into either short-term (stop topical steroid treatment)~     or long-term treatment (continue steroids once daily until 12 months).~   "
237175|NCT00450827|"~     RATIONALE: Monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8 and~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Bevacizumab may also stop the growth of neuroblastoma by blocking blood~     flow to the tumor. Giving iodine I 131 monoclonal antibody 3F8 together with bevacizumab may~     kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131~     monoclonal antibody 3F8 when given together with bevacizumab in treating patients with~     relapsed or refractory neuroblastoma.~   "
237163|NCT00450983|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood~     stem cell and donor natural killer cell transplant helps stop the growth of cancer and~     abnormal cells and helps stop the patient's immune system from rejecting the donor's stem~     cells. When certain stem cells from a donor are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells. Removing the T cells from the donor cells before transplant may stop this from~     happening.~      PURPOSE: This phase II trial is studying how well giving a donor peripheral stem cell~     transplant and a donor natural killer cell transplant after total-body irradiation, thiotepa,~     fludarabine, and muromonab-CD3 works in treating patients with leukemia or other blood~     diseases.~   "
237164|NCT00450970|"~     The SPERA trial is designed to 1. provide satraplatin to physicians with patients who have~     hormone refractory prostate cancer (HRPC) which has progressed following unlimited cytotoxic~     chemotherapy regimens for metastatic disease and 2. to evaluate the safety of oral~     satraplatin in this patient population.~   "
237165|NCT00450957|"~     This randomized phase I trial is studying the side effects and best dose of lycopene in~     healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from~     forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.~   "
237166|NCT00450944|"~     RATIONALE: Immunotoxins, such as anti-CD19 and anti-CD22, can find cancer cells that express~     CD19 and CD22 and kill them without harming normal cells. This may be an effective treatment~     for B-cell acute lymphoblastic leukemia.~      PURPOSE: This phase I trial is studying the side effects and best dose of anti-CD19 and~     anti-CD22 immunotoxins in treating patients with refractory or relapsed B-cell acute~     lymphoblastic leukemia.~   "
237167|NCT00450931|"~     RATIONALE: The way in which information about a drug is provided may affect the ability of~     patients and doctors to understand how a drug works and the side effects of the drug.~      PURPOSE: This randomized trial is studying how well a drug facts page works compared with a~     standard brief summary in helping patients and doctors understand medical information.~   "
237168|NCT00450918|"~     Mucociliary clearance, in which mucus secretions are cleared from the breathing airways, is~     the primary defense mechanism for the lungs. Inhaled particles, including microbes that can~     cause infections, are normally entrapped in mucus on the airway surfaces and then cleared out~     by the coordinated action of tiny hair-like structures called cilia. Individuals with primary~     ciliary dyskinesia (PCD) have defective mucociliary clearance, which in turn leads to lung~     infections and disease. The purpose of this study is to determine how lung disease progresses~     over time in children and adolescents with PCD.~   "
237169|NCT00450905|"~     This study is being performed to determine the safety and efficacy of Fralex Neuromodulation~     Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal~     pain associated with Fibromyalgia.~   "
237170|NCT00450892|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving these treatments before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery~     may kill any tumor cells that remain after surgery.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     docetaxel and lapatinib when given with or without combination chemotherapy and to see how~     well they work in treating women with locally advanced, inflammatory, or resectable breast~     cancer.~   "
237171|NCT00450879|"~     This pilot clinical trial studies how well pazopanib hydrochloride works in treating patients~     with breast cancer that is newly diagnosed or has come back at or near the same place as the~     original tumor and can be removed by surgery. Pazopanib hydrochloride may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by preventing the~     growth of new blood vessels necessary for tumor growth. Giving pazopanib hydrochloride before~     surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed.~   "
237172|NCT00450866|"~     RATIONALE: Drugs used in chemotherapy, such as epothilone B, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well epothilone B works in treating patients~     with CNS metastases from breast cancer.~   "
237173|NCT00450853|"~     Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving~     platinum-based chemotherapy will be randomized to receive granisetron 3 mg either~     subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine~     samples will be collected after each cycle.~   "
237174|NCT00450840|"~     The beneficial effect of statins to prevent cardiovascular events in patients at risk is well~     established. Recent trials demonstrated that statins can exert a number of vascular actions~     independent of lipid lowering. Short-term simvastatin therapy recently has been reported to~     reduce mortality in 2 different animal models of sepsis. Pleiner and coworkers could~     demonstrate potent vasoprotective properties of simvastatin during Escherichia coli endotoxin~     induced endotoxemia in healthy volunteers. In a population-based cohort analysis it was~     demonstrated that administration of statins was associated with a reduced risk of subsequent~     sepsis. Thus, simvastatin treatment may offer a new therapeutic strategy for clinical~     conditions associated with inflammation like severe sepsis and septic shock. The aim of the~     present study is to test the hypothesis that short term treatment with simvastatin may~     mitigate the detrimental vascular effects of acute inflammation in patients admitted to the~     intensive care unit requiring treatment for septic shock.~   "
237187|NCT00450671|"~     The purpose of this study is to determine if the collagen plug method heals perirectal~     fistulae as well as the conventional seton method.~   "
237188|NCT00450658|"~     The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of~     development of ibuprofen-associated ulcers in patients who require long-term daily use of~     ibuprofen.~   "
237176|NCT00450814|"~     This phase I/II trial studies the side effects and best dose of vaccine therapy when given~     with or without cyclophosphamide and to see how well they work in treating patients with~     multiple myeloma that has come back (recurrent) or has not responded to previous treatment~     (refractory). Vaccines made from a gene-modified virus may help the body build an effective~     immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving vaccine therapy~     together with cyclophosphamide may be a better treatment for multiple myeloma.~   "
237177|NCT00450801|"~     RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with~     thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy followed by thalidomide works in treating patients with previously untreated~     mantle cell lymphoma.~   "
237178|NCT00450788|"~     Background:~      -Esophageal cancer is the most common cancer in Iran s Golestan Province. Nutritional~     deficiencies, ethnicity and environmental exposures might contribute to the development of~     this disease.~      Objectives:~      -To better understand the cause of esophageal cancer in Golestan Province and to reduce its~     occurrence there.~      Eligibility:~      -Adults from the Gonbad, Aq-Qala and Kalaleh districts of eastern Golestan Province in Iran.~      Design:~        -  The study is a collaboration between NIH, the Digestive Disease Research Center of~          Teheran University of Medical Sciences, and the International Agency for Research on~          Cancer.~        -  Participants complete a lifestyle questionnaire and food frequency questionnaire.~        -  Samples of participants blood, urine, hair and toenail clippings are obtained.~   "
237179|NCT00450775|"~     The purpose of this study is to evaluate the efficacy and patient acceptance of Dermatix Q~     for the prevention and treatment of scarring.~   "
237180|NCT00450762|"~     The rational for this trial is given by the knowledge that gemcitabine acts as a potent~     inhibitor of DNA repair and therefore may prevent adequate repair of platin-induced DNA~     damage. Gemcitabine is an excellent choice for combination therapy by its unique mechanism of~     action and favourable toxicity profile. The combination of gemcitabine and cisplatin was~     shown to be effective in several trials, producing response rates of 30-52 % in patients with~     pretreated metastatic breast cancer. To improve on tolerability and handling of the regime~     carboplatin may be the more appropriate choice for treatment. The mechanism of action of~     carboplatin is very similar to that of cisplatin. The rational for combining gemcitabine and~     carboplatin is based on their single-agent activities in metastatic breast cancer, the~     activity of this combination in other malignancies and on the fact that carboplatin has~     demonstrated efficacy comparable with cisplatin in several tumor types.~   "
237181|NCT00450749|"~     This randomized phase II trial studies how well different doses of lycopene work in treating~     patients undergoing radical prostatectomy for prostate cancer. The use of lycopene, a~     substance found in tomatoes, may keep prostate cancer from growing or coming back after~     surgery.~   "
237182|NCT00450736|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving celecoxib together with radiation therapy~     after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when~     given together with radiation therapy in treating patients with stage II or stage III soft~     tissue sarcoma of the arm, hand, leg, or foot that has been removed by surgery.~   "
237183|NCT00450723|"~     RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help~     find breast cancer that has spread to lymph nodes between the breasts. It may also help~     doctors plan the best treatment.~      PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy~     finds sentinel lymph nodes that are located between the breasts in patients with stage I or~     stage II breast cancer.~   "
237184|NCT00450710|"~     Evaluation to determine the safety of two laparoscopic procedures to control T2DM.~   "
237185|NCT00450697|"~     Premature infants, especially those less than 1250 gm at birth are extremely difficult to~     feed. For unknown physiologic reasons oral feeding also called enteral feeding is not well~     tolerated in these immature babies. Because of this challenge these infants require~     intravenous fluids solution called parenteral nutrition (TPN). Intravenous nutrition is~     inadequate because it cannot supply sufficient calories for growth both of body and brain.~     The composition of intravenous nutrition is also toxic to the liver.~      For those reasons it is very important to achieve adequate enteral nutrition in premature~     infants as soon as possible after birth. However the best feeding method for those babies has~     not been defined.~      Since premature babies are unable to suck and swallow properly, feeding is administered by a~     tube inserted into the infant's stomach. The timing between feeds is inconsistent. Some~     infants are fed every 3 hours, whereas others are fed every 4 hours.~      The purpose of this study is to determine which feeding method is better. We hypothesize that~     feeding every 4 hours by allowing more time for digestion will improve feeding tolerance in~     premature infants. In addition it will also facilitate discontinuation of TPN sooner, thus~     causing less side effects.~   "
237186|NCT00450684|"~     The objective of this multicentre prospective therapeutic study is to evaluate the effects of~     CRT on the right and left ventricular function of patients with CHD in the medium and long~     term. Patients who reject the randomization or cannot be paced with right ventricular pacing~     alone will be enrolled in group C with continuous biventricular pacing, which is the main~     group in this study. Optional: Immediately after implantation the patients are divided into~     group A and B (randomized, single blind (for the patient), cross-over design).~      The treatment and the completing follow-up examination will take approximately 18 months and~     includes seven visits - one previous to the CRT and six at certain times afterward. At~     selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the~     global and regional ventricular function are performed. Subjective quality of life assessment~     (questionnaire) will also be performed at the defined follow-up intervals, and if applicable~     (optional) also objective assessment of the physical performance (VO2 max).~      55 patients also including children and adults with CHD are planned to be included in the~     study. The main target is to provide evidence of the effectiveness of CRT with biventricular~     stimulation in terms of improved ventricular function (ejection fraction and QRS interval).~   "
237189|NCT00450645|"~     The duration of anticoagulant treatment in cancer patients with Deep Vein Thrombosis (DVT) of~     the lower limbs is still uncertain. The present study addresses the possible role of the~     Residual Vein Thrombosis (RVT) for establishing the optimal duration of Low Molecular Weight~     Heparin (LMWH). Patients with a first episode of symptomatic unprovoked or provoked proximal~     DVT will received LMWHs for 6 months; RVT, ultrasonographically-detected, will be then~     assessed. Patients without RVT stop LMWH, whereas those with RVT will be randomized to either~     stop or continue OAT for additional 6 months. Patients were followed-up at least 1 year after~     anticoagulant discontinuation focusing on the study outcomes: occurrence of recurrent venous~     thromboembolism and major bleeding~   "
237190|NCT00450632|"~     The main objective of this study is to constitute a biotheque of patients with meningococcal~     disease to enable results to be interpreted and genetic factors to be determined~   "
237191|NCT00450619|"~     Background:~        -  No treatment is known to improve survival for prostate cancer patients who have not been~          helped by previous treatments with hormones and chemotherapy.~        -  An experimental vaccine called prostate specific antigen (PSA)/TRICOM contains genes for~          a protein produced by prostate cancer cells called prostate-specific antigen (PSA). The~          vaccine can trigger the immune system to make cells that may be able to recognize and~          attack the cancer cells that make PSA.~        -  Granulocyte macrophage colony stimulating factor (GM-CSF) is an approved drug that is~          usually given to increase a patient's white blood cell count or to stimulate the immune~          system.~        -  1Samarium-153-ethylene diamine tetramethylene phosphonate (53Sm-EDTMP) is a radioactive~          drug that has been approved for many years to treat advanced prostate cancer. It is~          given through a vein and can be targeted directly to tumors in the bone where it can~          relieve pain caused by bone lesions. Radiation also increases the level of certain~          proteins inside the tumor, making it easier for the immune system to find and kill the~          tumor cells.~        -  When laboratory mice were given just vaccine, just radiation, or a combination of both,~          the combination was most effective in treating tumors.~      Objectives:~      -To determine if combined treatment with PSA/TRICOM vaccine and 153Sm-EDTMP radiation can~     delay progression of prostate cancer better than radiation alone.~      Eligibility:~      -Patients who have advanced prostate cancer that has worsened despite treatments with~     hormones, have two or more bone lesions related to their prostate cancer, and have had prior~     treatment with docetaxel chemotherapy.~      Design:~        -  Patients are randomly assigned to receive radiation alone (Arm A) or radiation with~          vaccine and sargramostim (Arm B).~        -  Arm A receives 153Sm-EDTMP radiation starting on study day 8 and repeated every 12~          weeks.~        -  Arm B receives a priming vaccine on study day 1 and radiation on day 8. Radiation~          therapy is repeated every 12 weeks. Boosting vaccines are given on days 15 and 29 and~          then monthly. GM-CSF is given with each vaccination (on the day of the vaccination and~          for the next 3 days) to enhance the immune response. Vaccinations and GM-CSF are given~          as injections under the skin, usually in the thigh. Radiation therapy is given through a~          vein.~        -  Patients are monitored regularly with physical examinations, blood and urine tests, and~          scans to evaluate safety and treatment response.~        -  Patients who are human leukocyte antigen serotype within HLA-A A serotype group~          (HLA-A2)-positive undergo apheresis, a procedure similar to donating blood, for~          obtaining immune cells called lymphocytes to measure the immune response to the vaccine.~   "
237192|NCT00450606|"~     This study will check the efficacy of balneological therapy of bathing in Dead Sea fountain~     waters over a 6 week period on a twice a week basis (overall 12 treatments) in patients~     suffering from osteoarthritis of the knees.~   "
237193|NCT00450593|"~     RATIONALE: Identifying gene mutations and other risk factors in patients with melanoma and in~     families with a history of hereditary melanoma may help doctors identify persons at risk for~     melanoma and other types of cancer. It may also help the study of cancer in the future.~      PURPOSE: This clinical trial is studying gene mutations in patients with melanoma and in~     families with a history of hereditary melanoma.~   "
237194|NCT00450580|"~     This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study~     comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to~     fosamprenavir plus ritonavir 700mg/100mg twice-daily, both administered with~     abacavir/lamivudine 600mg/300mg once-daily in antiretroviral-naive HIV-1 infected adults.~     This study utilizes a group-sequential design with two stages: 1) an interim 24 week cohort~     analysis of approximately 200 subjects and 2) if study continuation criteria are met at this~     interim analysis, further enrolment of an additional 528 subjects, followed over a minimum of~     48 weeks. The objectives of the study are to demonstrate 1) non-inferior antiviral activity~     of fosamprenavir/ritonavir 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg~     BID and 2) a superior fasting non-HDL lipid profile in subjects receiving~     fosamprenavir/ritonavir 1400mg/100mg QD.~   "
237195|NCT00450567|"~     RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors~     predict how patients respond to treatment.~      PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell~     lung cancer treated with targeted therapy and chemotherapy.~   "
237196|NCT00450554|"~     The main objective of the study is to estimate the proportion of children, born between the~     01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and~     Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16~     clone related to a protection (>= 4), before and after the third MenBvac vaccination.~   "
237197|NCT00450541|"~     The goal of this research study is to learn what it is like when a patient with cancer has~     fatigue, as well as how these patients define fatigue. Researchers want to use this~     information to create questionnaires that may more accurately measure fatigue and its effects~     in patients with cancer.~   "
237198|NCT00450528|"~     The purpose of this study is to investigate the natural kinetics of D-dimers that occur after~     abdominal surgery.~   "
237199|NCT00450515|"~     RATIONALE: Drugs used in chemotherapy, such as vinflunine and capecitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving vinflunine together with~     capecitabine works in treating patients with previously treated metastatic breast cancer.~   "
237211|NCT00450359|"~     RATIONALE: A computer-aided detection program may help doctors find breast cancer sooner,~     when it may be easier to treat, in women undergoing screening mammography.~      PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer~     detection works in women undergoing screening mammography.~   "
237212|NCT00450333|"~     The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly~     and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as~     measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of~     efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients~     previously stable on EPO, as measured by Hb over Weeks 16 to 24.~   "
237213|NCT00450320|"~     RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sirolimus also may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth and by blocking blood flow to the tumor.~      PURPOSE: This pilot study is studying sirolimus in treating patients with HIV-related~     Kaposi's sarcoma.~   "
237200|NCT00450502|"~     Background:~        -  Batracylin advanced through the National Cancer Institute (NCI) drug development~          pipeline until its evaluation at Stage 3 on July 1989, It was then proposed for a phase~          I investigation based on its activity against as TOPO II inhibitor in s.c. mouse colon~          38, PANC03, COLO9, and cisplatin- and doxorubicin-resistant P388 tumors.~        -  IND-directed oral toxicology studies indicated interspecies variation in toxicity. Rats~          were found to be highly sensitive to batracylin. Ames et al showed that the interspecies~          variation in toxicity was consistent with the pattern of metabolism of the compound by~          N-acetyltransferase 2 (NAT2) to the acetylated form, N-Ac-batracylin, (a highly toxic~          molecule)~        -  We hypothesize that batracylin can be administered safely in slow acetylator NAT2~          genotype patients and can be rapidly evaluated for its potential as a tumor-suppressing~          agent.~      Objectives:~        -  Define the maximum tolerated dose, dose-limiting toxicities, and toxicity profile~          associated with the oral administration of batracylin daily x7 consecutive days,~          repeated every 28 days in patients with solid tumors and lymphomas.~        -  Define the pharmacokinetics of oral batracylin administered daily x7 consecutive days~          every 28 days.~        -  Obtain preliminary evidence of anti-tumor activity of batracylin in patients with solid~          tumors or lymphoma.~        -  Correlate polymorphisms in slow acetylators NAT2 genotypes (NAT2 5, NAT2 6, NAT2 7, and~          NAT2 14) with pharmacokinetics results.~        -  Evaluate the inter-subject variability and toxicity ratio, (N-Ac-Batra) / (batracylin).~        -  Evaluate the effect of batracylin treatment on gamma-H2AX levels in tumor biopsies.~      Eligibility:~        -  Patients must have a slow acetylator NAT2 genotype defined as NAT2 5, NAT2 6, NAT2 7, or~          NAT2 14.~        -  Patients with advanced, histologically confirmed malignancies refractory to standard~          therapy, or those for whom no standard therapy exists.~        -  Patients should have adequate liver, renal, and bone marrow function.~      Study Design:~        -  In accordance with the accelerated titration design 4B[3], dose levels will initially be~          increased at 100% increments, and one new patient per dose level will be treated~          according to a 4-week course.~        -  The accelerated phase ends when one patient experiences dose limiting toxicity (DLT)~          during the first course of treatment, or when two different patients experience grade 2,~          batracylin-related toxicity during the first course of treatment, or when the~          N-acetyl-batra AUC value reach 0.33 uM-Hour (i.e., the lower end of the range in the~          rat).~        -  When the first instance of grade 2 batracylin-related toxicity is observed, two~          additional patients must have been treated at that dose, or a higher dose (during any~          course), without experiencing moderate (grade 2) or worse (grade 3) toxicity, in order~          for the accelerated phase to continue.~        -  When the accelerated phase ends, the dose-escalation will revert to a more conservative,~          modified Fibonacci scheme with 40% dose-step increments, with at least 3 patients~          treated per dose level.~   "
237201|NCT00450489|"~     The purpose of this study is to evaluate the change score for the PedsQL short form Diabetes~     and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline~     (before changing care delivery models) and 12 months after transitioning to the team model of~     care delivery.~   "
237202|NCT00450476|"~     To evaluate the correlation between endotracheal tube size and incidence of dysfunction of~     suction lumen of Hi-Lo Evac endotracheal tube in critically ill patients who required~     mechanical ventilation for more than 48 hours.~   "
237203|NCT00450463|"~     Background:~        -  Flutamide is an approved drug for prostate cancer that blocks the effects of~          testosterone on prostate cancer cells and may slow the progression of the disease.~        -  The vaccine in this study consists of a priming vaccine called PROSTVAC-V/TRICOM, made~          from vaccinia virus, and a boosting vaccine called PROSTVAC-F/TRICOM, made from fowlpox~          virus. DNA is inserted into the priming and boosting vaccine viruses to cause production~          of proteins that enhance immune activity and also to produce prostate specific antigen~          (PSA) a protein that is normally produced by the patient s tumor cells.~        -  GM-CSF, given along with the vaccine, is a chemical that boosts the immune system. It is~          used in this study to try to increase the usefulness of the vaccine by increasing the~          number of immune cells at the vaccination site.~      Objectives:~      -To determine if treatment with a prostate cancer vaccine plus flutamide is more effective~     than flutamide alone in delaying disease progression in patients with prostate cancer.~      Eligibility:~        -  Patients 18 years of age and older with androgen-insensitive prostate cancer that has~          not spread beyond the prostate gland.~        -  Patients with a rising PSA who have already been treated with anti-iandrogen therapy~          (either bicalutamide or nilutamide).~      Design:~        -  There are two treatment groups in this study. Group A receives only flutamide; group B~          receive flutamide plus vaccine.~        -  Patients in both groups receive flutamide by mouth three times a day.~        -  Patients in group B receive PROSTVAC-V/TRICOM on day 1 and PROSTVAC-F/TRICOM on day 29~          and again every 4 weeks. All vaccines are given as injections under the skin.~        -  Patients have blood tests for PSA levels every month and scans every 3 months until the~          disease worsens.~        -  After 3 months of therapy, patients receiving in group A (flutamide alone) may cross~          over to receive vaccine if they develop a rising PSA and scans show no sign of disease~          spread. Patients in group B (flutamide plus vaccine) stop flutamide and may continue~          vaccine therapy. At this point patients may continue to receive treatment until the~          disease progresses or PSA levels rise....~   "
237204|NCT00450450|"~     This randomized phase III trial is studying donor bone marrow transplant with or without~     G-CSF to compare how well they work in treating young patients with hematologic cancer or~     other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow~     transplant helps stop the growth of cancer or abnormal cells. It also helps stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving methotrexate~     and tacrolimus or cyclosporine before and after transplant may stop this from happening. It~     is not yet known whether donor bone marrow transplant is more effective with or without G-CSF~     in treating hematologic cancer or other diseases.~   "
237205|NCT00450437|"~     This study will evaluate the lot to lot consistency, safety and immune response of the~     Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.~   "
237206|NCT00450424|"~     RATIONALE: The use of a CD-ROM may help patients with colorectal cancer or a family history~     of colorectal cancer make informed decisions about undergoing microsatellite instability~     (MSI) testing.~      PURPOSE: This randomized clinical trial is studying an educational CD-ROM to see how well it~     works compared with standard informed consent to assist decision-making about MSI testing in~     patients with colorectal cancer or a family history of colorectal cancer.~   "
237207|NCT00450411|"~     RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a~     tumor to kill tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided~     implant radiation therapy works in treating patients with locally recurrent prostate cancer~     previously treated with external-beam radiation therapy.~   "
237208|NCT00450398|"~     The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of~     ischemia reperfusion injury following liver transplantation by administering YSPSL into the~     liver graft directly ex vivo via the portal vein and to the recipient intravenously prior to~     reperfusion. Recently, P-selectin expression has been associated in liver grafts with~     prolonged cold storage times and rejection. By examining biomarkers of IRI including~     P-selectin by immunohistochemistry and/or quantitative PCR, liver histology and hepatic blood~     flow using established techniques, the goal of this study is to evaluate the feasibility of~     using these modalities for future studies of safety and efficacy.~   "
237209|NCT00450385|"~     The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell~     lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or~     by presence of biomarkers associated with the anti-tumor effects of Rituximab.~   "
237210|NCT00450372|"~     RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an~     amino acid needed for cell growth.~      PURPOSE: This phase II trial is studying how well pegylated arginine deiminase works in~     treating patients with metastatic melanoma that cannot be removed by surgery.~   "
250282|NCT00276250|"~     Islet transplantation in type 1 diabetics with hypoglycemic unawareness using abatacept as a~     part of a novel calcineurin-inhibitor-sparing immunosuppressive regimen.~   "
237214|NCT00450307|"~     RATIONALE: Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Colony-stimulating factors, such as GM-CSF,~     may increase the number of immune cells found in bone marrow or peripheral blood. Giving~     monoclonal antibody therapy together with GM-CSF may be an effective treatment for~     neuroblastoma.~      PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody~     3F8 when given together with GM-CSF in treating young patients with high-risk, refractory or~     relapsed neuroblastoma.~   "
237215|NCT00450294|"~     The objective of this study will be to answer a clinical question that has not already been~     investigated; that is, what are the effects of aortic infra-renal clamping and unclamping on~     intraocular pressure during Abdominal Aortic Aneurysm (AAA) repair? Depending on the results,~     this study may raise or alleviate concern that vascular surgery for abdominal aortic aneurysm~     could contribute to early perioperative exacerbation of pre-existing eye disease and increase~     a patient's vulnerability to developing a type of blindness known as ischemic optic~     neuropathy. The purpose of this observational study is to evaluate whether intraocular~     pressure measurements with a handheld tonometer will detect changes in intraocular pressure~     related to intraoperative events during aortic cross clamping and unclamping that may provide~     information on causes of perioperative blindness.~   "
237216|NCT00450281|"~     RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07)~     and non-smokers with cancer in the laboratory may help doctors learn more about changes that~     occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more~     about risk factors for lung cancer and may help the study of cancer in the future.~      PURPOSE: This clinical trial is studying carcinogens in lung tissue from smokers (closed to~     entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III~     non-small cell lung cancer.~   "
237217|NCT00450268|"~     We plan to investigate prospectively and simultaneously skin and blood DC subtypes, their~     donor/recipient origin and the correlation of DC reconstitution kinetics with treatment,~     clinical outcome and incidence of aGvHD in patients undergoing allogeneic hematopoietic stem~     cell transplantation.~   "
237218|NCT00450255|"~     This phase II trial is studying how well VEGF Trap works in treating patients with recurrent~     stage III or stage IV melanoma that cannot be removed by surgery. Combinations of biological~     substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma~     cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.~   "
237219|NCT00450242|"~     -  Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability~          to have sexual intercourse and decreased pain scores in women with vestibulitis when~          compared to placebo.~        -  This is a study to assess if topical lidocaine will improve symptoms in women with~          vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo~          ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total~          of 56 women in the study.~   "
237220|NCT00450229|"~     Giving diindolylmethane, a substance found in cruciferous vegetables, may help doctors learn~     more about how diindolylmethane is used by the body. This randomized phase I trial is~     studying the side effects and best dose of diindolylmethane compared with a placebo in~     treating patients undergoing radical prostatectomy for stage I or stage II prostate cancer.~   "
237221|NCT00450216|"~     The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of~     development of ibuprofen-associated ulcers in patients who require long-term daily use of~     ibuprofen.~   "
237222|NCT00450203|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cisplatin, and capecitabine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, and small molecule~     tyrosine kinase inhibitors, such as lapatinib, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor~     cells by blocking blood flow to the tumor. Lapatinib targets a specific growth receptor,~     HER-2. Chemotherapy together with bevacizumab or lapatinib, in HER-2 positive tumours, may~     kill more tumor cells.~      PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving~     combination chemotherapy together with bevacizumab works compared with combination~     chemotherapy alone in treating patients with previously untreated stomach cancer,~     gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery.~     The feasibility study is studying the safety of adding lapatinib to chemotherapy in patients~     with HER-2 positive previously untreated stomach cancer, gastroesophageal junction cancer or~     lower oesophageal cancer that can be removed by surgery. The feasibility study will also~     assess the feasibility of timely HER-2 testing and estimate the HER-2 positivity rate in this~     patient population.~   "
237223|NCT00450190|"~     The aim of the study is to evaluate the E-Device performances and handling on the use in~     common practice, by collecting the impressions of patients, nurses and the investigator on~     the graphic interface, the instructions manual, the E-Device training and the material~     itself.~   "
237224|NCT00450177|"~     The purpose of this study is to investigate the efficacy of enteral iron supplementation for~     improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in~     patients who are hospitalized in the intensive care unit. This study will also address any~     relationship between enteral iron supplamentation and risk of infection.~   "
237225|NCT00450164|"~     Controlled and randomized study comparing combined treatment (nadolol and endoscopic~     ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to~     hemodynamic response, in the prevention of esofagic verices rebleeding.~   "
237226|NCT00450151|"~     In this study the focus will be on correlating the levels of platelet activation markers~     (proteins that are released when blood cells are activated)to the duration of cardiopulmonary~     bypass, temperature during cardiopulmonary bypass and the weight of the patient.~   "
237227|NCT00450138|"~     The purpose of this study is to determine the maximum tolerated dose of ZD6474 given in~     combination with radiation or in combination with chemotherapy and radiation in patients with~     squamous cell carcinoma of the head and neck.~   "
237228|NCT00450125|"~     The goal of this clinical research study is to compare the 6-minute walk test with the~     exercise stress test, in patients who may have lung surgery. Researchers want to find out if~     the 6-minute walk test is as good as the exercise stress test at predicting possible~     complications that may occur after lung surgery.~   "
237229|NCT00450112|"~     The purpose of this study is to determine if a single or repeat intra-articular injection of~     Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to~     determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.~   "
237230|NCT00450099|"~     Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the~     most commonly used drugs for that purpose. The efficacy of a certain medication injected~     epidurally depends on the dose that is given. A certain dose can be administered in different~     concentrations, which will consequently mean different volumes. Our hypothesis is that for~     each concentration of a certain drug, there has to be a minimum effective volume that will be~     associated with the best possible performance of the drug. This study is being conducted to~     find the minimum volume of bupivacaine (a local anesthetic) that produces successful~     analgesia in 95% of patients in labor.~   "
237231|NCT00450086|"~     The purpose of this study is to determine whether budesonide or mesalazine is more active in~     the treatment of collagenous colitis.~   "
237232|NCT00450073|"~     The purpose of this study is to establish an effective method to correct vitamin D deficiency~     in subjects with cystic fibrosis. The investigators will examine cholecalciferol,~     ergocalciferol and UV light.~   "
237233|NCT00450060|"~     The purpose of this study is to compare postlumbar puncture complaints as headache or~     backache after lumbar puncture with needles with Quincke design or with Sprotte design in~     children and adolescents.~   "
237234|NCT00450047|"~     The purpose of this study is to verify the efficacy of speed-feedback therapy in improving~     the cognitive function of elderly people with dementia by a randomized controlled trial, and~     to demonstrate how that affects ADL and QOL.~   "
237235|NCT00450034|"~     A randomized trial has been designed to determine if this complex intervention can~     significantly decrease the risk of unplanned readmissions in this very elderly population,~     compared with usual care.~   "
237236|NCT00450021|"~     This study will test a new radioactive tracer, [(11)C]MePPEP, for use in positron emission~     tomography (PET) imaging. The tracer is used to visualize cannabinoid receptors, proteins in~     the brain that mediate a variety of natural chemicals. These receptors may be important in~     behavioral diseases such as addiction, obesity and psychiatric diseases.~      Healthy normal volunteers between 18 and 65 years of age may be eligible for this study.~      Ten participants undergo whole body PET imaging to determine where the [(11)C]MePPEP tracer~     is distributed in the body in order to calculate radiation exposure from the tracer. Another~     10 subjects undergo brain imaging with [(11)C]MePPEP to measure cannabinoid receptors in the~     brain.~      All participants are evaluated with a medical history and physical examination, blood and~     urine tests and an electrocardiogram (ECG) before scanning. They then have a PET scan. For~     this procedure, a catheter (plastic tube) is placed in a vein in the arm through which the~     tracer is injected. A special mask is fitted to the head and attached to the bed to help keep~     the head in place during the scan. Subjects undergoing brain imaging also have a catheter~     placed in an artery in the wrist from which blood samples are collected during the procedure.~     The scan lasts about 2 to 2.5 hours.~      Subjects undergoing brain imaging also have magnetic resonance imaging (MRI) within 1 year of~     the PET scan. For MRI, the subject lies on a bed that moves into the tubular scanner, wearing~     earplugs to protect the ears from loud noises that occur during the scan. The procedure takes~     about 1 hour.~   "
237237|NCT00450008|"~     The purpose of this study is to assess the relative efficacy and toxicity of combination~     therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising~     PSA.~   "
237238|NCT00449995|"~     Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The~     ideal situation for the endoscopist is to visualize cellular structures, which implies having~     microscopic imaging available. A potential candidate to fill this gap could be confocal~     fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold~     standard with the confocal fluorescence microscopy for detection of metaplastic - or~     intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has~     been initiated.~   "
237239|NCT00449982|"~     The purpose of this study is to investigate the clinical efficacy, safety and tolerability of~     a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external~     genitial warts in male and female patients.~   "
237240|NCT00449969|"~     The purpose of this study is to determine whether an online automatic feedback improved CPR~     quality (No-flow time, compression depth, short-term survival and one year follow up) in this~     prospective randomised study of out-of-hospital cardiac arrest~   "
237241|NCT00449956|"~     The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%)~     with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in~     patients with glaucoma and ocular hypertension.~   "
237242|NCT00449943|"~     Cardiovascular disease and ischemic heart disease is the #1 killer in Canada. Currently,~     Cardiac invasive catheterization angiography (CICA) is the gold standard for the assessment~     of the arteries in the heart. However, cardiac catheterization has risks which prohibit its~     use in all patients. These risks include: death, heart attack, stroke and bleeding. Cardiac~     computed tomography angiography (CTA) is a new non-invasive technology which may enable the~     evaluation of patients' coronary anatomy without exposing patients to the risks of invasive~     cardiac catheterization.~      The purpose of this project is to compare CT angiography (CTA) to Tc-99m single photon~     emission computed tomography (Tc-99m SPECT)~      We will enroll patients who are waiting for a CICA or who have been referred for a TC-99m~     SPECT or CTA scans at the University of Ottawa Heart Institute. Consenting patients who are~     waiting for a CICA will have both a CTA and a Tc-99m SPECT scan. Consenting patients referred~     for a CTA or Tc-99m SPECT will have both the CTA and Tc-99m SPECT in a random order but not~     CICA (unless ordered by your physician).~   "
237243|NCT00449930|"~     A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used~     medication in patients with type 2 diabetes~   "
237244|NCT00449917|"~     The purpose of this study is to determine the benefits of Visiobiane Anti-age dietary~     supplement on macular pigment optical density, contrast sensibility and visual acuity.~     Additionally, the study would like to evaluate seric variations of carotenoids and the total~     antioxydant capacity.~   "
237245|NCT00449904|"~     This is an open-label, single-arm clinical study investigating the long-term safety of~     ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic~     insufficiency (PI).~   "
237246|NCT00449891|"~     This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning,~     behavior and development in young children and whether there are associated changes on their~     MRI scan.~   "
237247|NCT00449878|"~     This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic~     fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).~   "
237248|NCT00449865|"~     The purpose of this trial is to determine if the nutritional supplement creatine slows the~     progression of Parkinson's disease over time.~   "
237249|NCT00449852|"~     A randomized control trial is planned to evaluate an interactive voice response (IVR)~     mediated follow-up and triage system, against usual care, to help smokers hospitalized with~     Coronary Heart Disease (CHD) to quit smoking. The investigators hypothesize that compared to~     usual care, participants in the IVR group will; a) have a significantly higher 7-day point~     prevalence abstinence rate at 26 and 52 weeks after hospital discharge, b) will have a higher~     rate of continuous abstinence at 26 and 52 weeks after hospital discharge, c) will use a~     greater number of proven effective interventions over time, and d) will develop greater~     self-efficacy with respect to smoking cessation, over time.~   "
237250|NCT00449839|"~     A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of~     three different periods A, B and C where a constant the insulin infusion rate is given during~     the periods. In period B and C will the infusion start with a bolus.~      It will be investigated if a steady state of insulin will be obtained faster in period B and~     C then A.~   "
237251|NCT00449826|"~     The purpose of this project is to examine the effectiveness of computed tomographic~     angiography (CTA) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).~     People who are hospitalized with this situation often require an angiogram to assess the~     heart and its arteries.~      Recent advancements in technology have enabled CTA to clearly define coronary artery anatomy~     with great accuracy and to guide treatment strategies in select patient populations. We are~     investigating that CTA may be used, as an alternative to conventional angiograms, for the~     risk stratification of patients with high risk NSTE-ACS.~      Patients eligible for the study will be high risk NSTE-ACS and awaiting an angiogram.~     Enrolled patients will undergo CTA prior to the angiogram. With each CTA the patient will be~     injected with a small dose of an X-ray dye and will be asked to lie still on the scanning~     bed for a period of 5-10 minutes.~   "
237252|NCT00449813|"~     The aim of the study is to compare two different endpoint measures: heartburn as assessed by~     the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by~     the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated~     with a daily dose of 40 mg oral pantoprazole over an 8-week period.~   "
237253|NCT00449800|"~     Ceftriaxone pharmacokinetics variability in intensive care unit septic patients~      In intensive care units, drug dosage is often based on study made on healthy volunteers or on~     less severe patients.~      However, pharmacokinetic alterations have been described for some drugs used in intensive~     care units.~      These alterations, consequences of alteration of volume of distribution, of protein~     concentrations, of impaired hepatic and renal functions can result in accumulation with~     toxicity or « under dosage » with inefficacity.~      Ceftriaxone is an antibiotic often prescribed in intensive care unit. However, despite this~     large utilisation, very few data is available on the pharmacokinetic in intensive care unit,~     and optimal dosage is not known.~      Our objective is to develop a population pharmacokinetics model of ceftriaxone in intensive~     care unit patients with sepsis, severe sepsis and septic shock and to identify the « data »~     explaining interindividual variability of each pharmacokinetics parameter.~   "
237254|NCT00449787|"~     2/3 of patients discharged from an emergency department after treatment for an acute headache~     will still be bothered by headache within 24 hours of emergency department (ED) treatment.~     The goal of this study is to compare two medications, naproxen and sumatriptan, to determine~     which is better for the treatment of recurrent headache within 24 hours of emergency~     department discharge.~   "
237255|NCT00449774|"~     This study intends to demonstrate bioequivalence of two formulations, the effect of food and~     water on one formulation and safety and tolerability of two formulations of lamotrigine in~     healthy male and female volunteers~   "
237256|NCT00449761|"~     This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic~     myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant~     disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors~   "
237257|NCT00449748|"~     The goal of this clinical research study is to see if RAD001 can help to control the disease~     in patients with systemic mastocytosis (SM). The safety of this treatment will also be~     studied.~   "
237258|NCT00449735|"~     This proposed study aims to document the risk factors for quinolone resistance in bloodstream~     isolates of E. coli. Additionally, the adequacy of empiric antibiotic therapy for E. coli~     bloodstream infections will be assessed. Finally, outcome will be recorded - this is~     all-cause mortality at 28 days from the time of the first positive blood culture. Hypothesis:~     Ciprofloxacin resistant strains are associated with admission from nursing home and with~     prior quinolone use.~   "
237259|NCT00449722|"~     To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing~     of total 3.0 g mesalazine granules in patients with active ulcerative colitis~   "
237260|NCT00449709|"~     PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity~     and mortality and is frequently associated with long-term disability. Oxytocin is a hormone~     produced by the body during labor. GSK221149 is an experimental drug that will be used to~     block the effects of oxytocin, and therefore pause or prevent contractions. In this study,~     the pharmacokinetics of various modified release formulations of GSK221149 will be~     investigated in healthy non-pregnant adult subjects.~   "
237262|NCT00449683|"~     The study consists of measurement of antidepressant-induced excessive sweating and its~     treatment with an experimental medication, terazosin (approved for hypertension), that will~     be added to the antidepressant. This study is for people who take an antidepressant due to a~     depressive disorder. This is an open-label study (no placebo group) that will last 5 weeks,~     with one week of baseline measurement and four weeks of treatment with the study medication.~     The study is based on the hypothesis that terazosin will be effective in reducing the~     severity of excessive sweating caused by antidepressant treatment, and will have minimal~     side-effects.~   "
237263|NCT00449670|"~     The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a~     GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults~     aged between 18 and 60 years.~   "
237264|NCT00449657|"~     This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel~     with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA~     and IIIB non-small cell lung cancer~   "
237265|NCT00449644|"~     The objective of this study is to demonstrate that the antibacterial activity of TMC207 is~     better than placebo when added to a standardized Background Regimen (BR) for treatment of~     multi-drug resistant TB. Also safety and tolerability will be evaluated.~   "
237266|NCT00449631|"~     We investigate whether mitomycin C treatment during previous filtration surgery induces~     P-glycoprotein expression.~   "
237267|NCT00449618|"~     Aspirin (ASA) has been shown to provide marked benefits in the prevention of cardiovascular~     events, although the potential direct effects of ASA on cardiovascular function remain~     uncertain. Previous studies have demonstrated that ASA is a potent antioxidative agent that~     markedly reduces vascular production of superoxide in normotensive and hypertensive rats. In~     addition, ASA was found to prevent angiotensin II-induced hypertension and cardiovascular~     hypertrophy, mainly through its antioxidative properties in preventing the generation of~     superoxide, although ASA apparently did not appear to reduce hypertensive levels of blood~     pressure (BP). Moreover, recent results have demonstrated that ASA induces nitric oxide (NO)~     release from vascular endothelium. No attention has been paid, so far, to potential~     administration time-dependent effects in these studies.~      Previous laboratory animal and clinical trial research convincingly demonstrates~     administration time-dependent (with reference to circadian rhythms) effects of ASA. Thus, the~     effects of ASA upon lipoperoxides, β-adrenergic receptors, and BP in clinically healthy~     subjects depend on the circadian timing of ASA administration. Most important, the~     administration time-dependent influence of ASA on BP was previously demonstrated in a~     randomized trial on healthy women and in other independent, double-blind, randomized,~     placebo-controlled clinical trials. The first was conducted on clinically healthy subjects, a~     second one on normotensive and hypertensive subjects, a third one on pregnant women at high~     risk for preeclampsia and a fourth one in previously untreated patients with mild~     hypertension. The findings of these BP studies are consistent; the BP-lowering effect of~     low-dose ASA is achieved when administered at bedtime but not upon awakening.~      In keeping with the chronopharmacological effects of ASA and the previous findings suggesting~     that ASA at low dose may have a potential beneficial effect on BP, this prospective,~     randomized, double-blind, crossover study will investigate the potential influence of ASA on~     BP in subjects with either high-normal BP or diagnosis of mild (grade 1) hypertension. The~     subjects will receive low-dose ASA or placebo at different times of the day according to~     their rest-activity cycle, and will be evaluated by 48-hour ambulatory BP monitoring before~     and after 6 weeks of pharmacologic intervention.~   "
237268|NCT00449605|"~     The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of~     rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin~     (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with~     metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.~      The main secondary objectives are to assess the effect of rimonabant in comparison with~     glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of~     rimonabant in comparison with glimepiride.~   "
237269|NCT00449592|"~     Zinc is an intracellular mineral with important enzymatic cofactor activities for cell~     membrane stability, DNA and RNA structure. Zinc deficiency is associated with delayed wound~     healing and immune dysfunction. In patietns with hematological malignancies an inverse~     correlation was found between disease stage and zinc level. Patients undergoing high dose~     chemotherapy for hematologic malignancies are predisposed to develop oral and~     gastrointestinal complications, in particular oral mucositis. These patients may have~     relative zinc deficiency, therefore oral zinc therapy may be benefical in the prevention of~     these complications.~   "
237270|NCT00449579|"~     The main objective of this study is to determine the usefulness of the HyperQ™ System in~     improving the positive predictive value of conventional ECG stress testing.~      Patients who are referred for stress test will perform an ECG stress test on a treadmill,~     with high-frequency ECG recording from conventional 12 leads using BSP's HyperQ™ System.~     Conventional 12 lead ECG, as well as HyperQ™ recordings will be provided by the HyperQ™~     System. The results of the conventional test and the HyperQ™ data will be compared, using one~     of three cardiac tests (stress echocardiography, SPECT myocardial perfusion imaging and~     angiography) as gold standards.~      Statistical analysis will compare the sensitivity, specificity, PPV and NPV of the~     conventional and HyperQ™ stress ECG in detecting myocardial ischemia.~   "
237271|NCT00449566|"~     The purpose of this study is to investigate brain development in autism by longitudinally~     assessing children with autism, as well as typically developing controls, using advanced MR~     techniques. We will use longitudinal diffusion tensor imaging (DTI) measures to investigate~     the protracted development of long-range white matter fibers in autism. In addition, we will~     investigate the effect of autism risk genes on brain development.~   "
237272|NCT00449553|"~     The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood~     lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma~     receptor after 6 months of pioglitazone, once daily (QD), treatment.~   "
237273|NCT00449540|"~     Assess safety and efficacy of Transcranial Magnetic Stimulation (TMS) for the treatment of~     migraine with aura~      The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop~     or interrupt the spreading cortical brain activity that causes or contributes to the migraine~     headache. Two TMS treatments at an intensity of <1 Tesla for ~500 microseconds, approximately~     30 seconds apart, may stop the aura and prevent the subsequent headache.~   "
237274|NCT00449527|"~     The purpose of this study is to demonstrate whether subjects respond similarly to the Onset~     of Effect Questionnaire (OEQ) using a 1 week recall period versus a 1 day recall period.~   "
237291|NCT00449280|"~     The goal of this study is to determine whether a significant pharmacokinetic interaction~     exists between rapamycin and sorafenib.~      This study will also look at the toxicity of the combination of rapamycin and sorafenib and~     the antitumor activity of the combination in subjects with advanced cancers.~   "
237292|NCT00449267|"~     The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured~     by aurolab are safe and effective in the surgical treatment of cataract.~   "
237275|NCT00449514|"~     About 10-15% of all couples attempting to conceive will not become pregnant within one year.~     Among those, the majority will have ovulatory dysfunction, mild male infertility or~     unexplained infertility. The traditional first line therapy for those couples is ovulation~     induction or superovulation using clomiphene citrate. Probably due to anti-estrogenic effects~     of this agent will, some patients will have a thin endometrium as measured by sonography at~     the time of ovulation. This phenomenon may be associated with a lower chance to conceive.~     Tamoxifen is a similar molecule that has been used to clomiphene citrate that has been shown~     to be equally effective to clomiphene in ovulation induction. Preliminary observations showed~     that tamoxifen does not cause a negative effect on the endometrium as compared with~     clomiphene, and may increase the chance to conceive in those patients who have a thin~     endometrium under clomiphene.~   "
237276|NCT00449501|"~     The purpose of this study is to demonstrate whether subjects respond similarly to the Onset~     of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving~     SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2~     actuations twice daily.~   "
237277|NCT00449488|"~     The primary objective of this study is to establish the effects of a single bolus of EPO,~     administered within three hours after a primary PCI for a first acute myocardial infarction,~     on left ventricular function.~   "
237278|NCT00449462|"~     The knowledge of the health effects of CLA on the human body is limited. However, CLA~     supplements are sold over the counter in several countries and various techniques are used to~     increase the content of CLA in food.~      The CLAxon-study will be performed to investigate wether high doses of CLA can be safely~     given to healthy human volunteers.~   "
237279|NCT00449449|"~     The study tested the hypothesis that a pertubation with a lidocain solution will enhance~     pregnancy rate.~   "
237280|NCT00449436|"~     The current goal of antiretroviral therapy is to use a potent regimen that will suppress~     plasma viral load and maintain this suppression as long as possible. However, for most~     patients treated with such potent regimen, several problems can limit their long term~     effectiveness and contribute to incomplete viral suppression. These problems include poor~     tolerability, metabolic toxic effects. In order to avoid common problems as toxicity it might~     be interested to simplify treatment with fewer toxicity, lower pill burden. In this study we~     will evaluate the safety and efficacy of a simplification treatment with TRIZIVIR in long~     term after a Boosted PI or NNRTI containing regimen as first line therapy.~   "
237281|NCT00449423|"~     The primary objective of this study is to evaluate whether metabolic modulation improves~     hemodynamics and outcome in acute heart failure~   "
237282|NCT00449410|"~     In elderly patients with atrial fibrillation (AF) the presence of silent brain infarcts and~     neurocognitive deficit is high despite adequate treatment with oral anticoagulation.~     Atherosclerosis is considered to be a chronic inflammatory disease and thrombosis and~     inflammation are strongly correlated. Atrial fibrillation is linked with increased levels of~     inflammatory markers and intensive cholesterol lowering has proven to reduce inflammation. In~     a prospective double-blind randomized pilot-study we want to test the hypothesis, that~     addition of intensive cholesterol lowering treatment besides adequate oral anticoagulation~     will reduce cerebrovascular lesions and will be beneficial for neurocognitive status in~     elderly AF patients.~   "
237283|NCT00449397|"~     The purpose of this study is determine the minimal effective dose and the impact on:~        1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients~          experiencing the first psychotic episode~        2. the final maintenance doses~        3. the use of other medications~        4. the amount of changes to other antipsychotic medication~        5. the number of hospitalization days~   "
237284|NCT00449384|"~     The purpose of this study is to validate and to test interrater reliability for the Norwgian~     version of Severe Impairment Battery (SIB).~   "
237285|NCT00449358|"~     Correlation between Mohs surgery and microscopic fluorescence photometry in determination of~     histological borders in Basal Cell Carcinoma .~   "
237286|NCT00449345|"~     The ministry of health in Israel requires all health-care workers to undergo screening for~     latent Tuberculosis infection (LTBI) prior to starting work. This is based on the Mantoux~     skin test, which is notoriously unreliable.~      In recent years, more specific and sensitive tests based on interferon-gamma secretion to TB~     antigens have come to market, and most current evidence shows that many mantoux positive~     persons do not have LTBI. Quantiferon-GOLD is one of these assays.~      In this prospective study, we will draw blood for the Quantiferon-GOLD assay in parallel to~     conventional testing, and perform a cost-effectiveness analysis of the cost of the~     investigation and treatment of LTBI in health-care workers.~      We hypothesize that in spite of the cost of screening healthcare workers with~     Quantiferon-GOLD tests, the reduction in need for LTBI treatment and associated costs will~     render the test cost-effective.~   "
237287|NCT00449332|"~     The purpose of this research is to discover the different patterns of cytokine production in~     patients who may develop Bronchiolitis Obliterans Syndrome-0p (BOS-0p) which means ongoing~     rejection. This is an early indicator of chronic rejection in lung transplant recipients.~     These cytokines can be detected in the bronchoalveolar (lung) and tissue samples of lung~     transplant recipients.~   "
237288|NCT00449319|"~     The present therapy intends to be an homogeneous treatment for AML patients based on a~     pretreatment with hydroxiurea plus an induction therapy with the standard arm with~     Daunorubicine as according to EORTC-GIMEMA AML10 study.~      The post-remissional treatment is based on transplant with HLA compatible donor is foreseen~     for all patients and autologous transplant for those without HLA compatible donor available.~   "
237289|NCT00449306|"~     Lipid-rich atherosclerotic plaques, or vulnerable plaques are prone to rupture, causing~     local intravascular thrombosis, with subsequent grave clinical consequences. Atherosclerotic~     plaques normally removed during surgery, and peripheral blood samples will be studied to~     achieve the following objectives:~      1 Define histological features of the vulnerable plaque, analyze its physical~     characteristics, and investigate selected gene expression.~      2 Study biomarkers of inflammation in conjunction with the presence of vulnerable plaques.~      3 Explore the potential role of infection in atherogenesis.~   "
237290|NCT00449293|"~     The objective of this pilot research is to investigate the effects of two behavioral smoking~     cessation programs on aspects of cue-induced cigarette craving, and to further investigate~     the neural bases of such effects.~   "
237295|NCT00449228|"~     We propose to evaluate a preoperative education of the patient and a new surgical technique~     (the mini-invasive THR) that could reduce the time to achieve functional independence.~      The primary objective of the trial is to assess the time to reach functional independence~     after total hip replacement depending on the treatment groups: preoperative education versus~     no preoperative education and mini-invasive procedure versus standard procedure. The study~     hypothesis is that education and mini-invasive procedure will reduce the time to reach~     functional independence.~      This is a prospective trial with a double randomization.~   "
237296|NCT00449215|"~     The genetic bases of peak bone mass in males, as determinants of an individual’s risk of~     developing osteoporotic fractures in old age and their interaction with dietary and lifestyle~     factors are still poorly understood.~      Our objective was to examine the relative contribution of genetic and environmental variables~     to the regulation of peak bone mass in a population-based cohort of young healthy men,~     focusing on the BsmI polymorphism of vitamin D receptor (VDR)gene and the AluI polymorphism~     of calcitonin receptor (CTR)gene.~   "
237297|NCT00449202|"~     The purpose of this study is to evaluate the safety, preliminary efficacy, and~     pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult~     subjects.~   "
237298|NCT00449176|"~     The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety~     of orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250~     mg twice daily in patients with moderate to severe chronic pain of the lower back, in~     comparison with placebo and Oxycodone Controlled Release (CR).~   "
237299|NCT00449163|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab~     may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving~     combination chemotherapy together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with bevacizumab works in treating patients with stage IV colorectal cancer.~   "
237300|NCT00449150|"~     Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is~     characterized by an enlargement of the prostate occurring in human male over the age of 50~     which increases in prevalence with age, and among those aged 50 to 80, about 40% report~     moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve~     patients' quality of life which primarily depends on the severity of the symptoms of BPH.~     Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.~      For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection~     in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to~     52) are eligible to receive the active drug during the open-label part of the study (Week 52~     to 90).~   "
237301|NCT00449137|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Arsenic trioxide may help fluorouracil and leucovorin work better by making tumor~     cells more sensitive to the drugs. Giving arsenic trioxide together with fluorouracil and~     leucovorin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide~     and fluorouracil when given together with leucovorin in treating patients with stage IV~     colorectal cancer that has relapsed or not responded to treatment.~   "
237302|NCT00449124|"~     The purpose of this study is to evaluate the safety and effectiveness of an investigational~     vaccine (TG4040) to prevent hepatitis C virus (HCV) infection. The primary goal of this study~     is to determine the safety of increasing doses of TG4040 versus placebo (an inactive~     substance) in subjects chronically infected with HCV. Approximately 85 patients, ages 18-65~     years, with chronic HCV infection will be enrolled in this study at two sites, Saint Louis~     University and Cincinnati Children's Hospital. Volunteers will receive doses of TG4040 and~     placebo by injections into the thigh on different days, depending on which study group they~     belong to. Safety will be checked before doses are increased, and each participant will~     receive the study vaccine, TG4040, at some point during the study. Each subject will~     participate in the study for 8 months. This study may help produce a new vaccine that would~     improve control of HCV.~   "
237303|NCT00449111|"~     Evaluate blood pressure after 6 weeks of treatment with COZAAR plus.~   "
237304|NCT00449098|"~     The purpose of this study is to compare the safety and effectiveness of the ologen~     (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.~   "
237305|NCT00449085|"~     Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic~     Ultrasound Catheter.~   "
237306|NCT00449072|"~     The primary objective of the study was to characterize the difference in prepubescent growth~     velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with~     triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo~     (NASACORT® AQ placebo group) for 12-months.~      The secondary objectives were to compare the following in prepubertal participants treated~     with TAA nasal spray versus placebo:~        -  the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure~          the Hypothalamic-Pituitary Adrenal [HPA] axis function)~        -  the rate of treatment-emergent-adverse-events (TEAE)~        -  global efficacy rated by the investigator and the participant separately~        -  the rate of use of rescue medication during the study~   "
237307|NCT00449059|"~     The aim of the study was to evaluate the acute effect of nitroglycerine infusion on blood~     pressure and heart rate in heart-transplanted patients with cyclosporine-induced~     hypertension.~   "
237308|NCT00449046|"~     This study evaluates the long-term (24-week) safety and efficacy of GW815SF~     Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of~     25/50mcg) bid in pediatric patients with bronchial asthma.~   "
237309|NCT00449033|"~     Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for~     the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)~   "
237310|NCT00449020|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, irinotecan, and docetaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     combination chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving carboplatin and irinotecan together~     with radiation therapy followed by docetaxel works in treating patients with newly diagnosed~     stage III non-small cell lung cancer.~   "
237311|NCT00449007|"~     We will study patients with a current major depressive episode, comorbid alcoholism and a~     history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for~     risk of alcohol withdrawal prior to randomization. The study will provide six months of~     antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse~     prevention. Patients will also be encouraged to attend daily Alcoholics Anonymous meetings.~     The outcome measures will be: 1) occurrence of suicide events; 2) reduction of suicidal~     ideation; 3) reduction in neuropsychological measures of impulsivity.~   "
237312|NCT00448994|"~     This study is designed to determine the rate at which stem cell transplant patients can~     develop infection caused by a group of viruses, known as adenovirus, and common fungi. Stem~     cells are unspecialized cells, capable of producing more stem cells or other specialized~     cells, and are used to replace damaged or diseased cells. The study will be conducted in~     children (2-17years old) being transplanted with stem cells from a donor. Patients undergoing~     stem cell transplantation are more likely to develop infections as their immune systems are~     weakened. Blood, stool, urine and throat swab samples will be collected (for at least 100~     days on a weekly basis) to detect infection(s) caused by adenovirus or fungus. Subjects will~     participate for up to 1 year following the transplant procedure.~   "
237313|NCT00448981|"~     Colds and flu cause much loss of work and school. The purpose of this study is to try to~     reduce the transmission of colds and flu among household members with one of three~     interventions: some educational material, educational material and use of alcohol hand~     sanitizers, and educational material and use of alcohol hand sanitizers as well as face masks~     when somebody has symptoms of the flu. We will recruit 450 households in Northern Manhattan~     and each household will be randomly assigned to one of these three groups. We will then~     follow these households for 15 months to see how often they get cold and flu symptoms. We~     will also look at antibiotic use practices for symptoms of colds and influenza ; household~     member knowledge of prevention and treatment strategies for pandemic influenza and viral~     URIs; and rates of influenza vaccination among household members. When someone in the study~     has serious flu symptoms such as a high fever and cough or sore throat, we will also obtain a~     nasal culture (by swabbing the nose) to see if there is flu virus present.~   "
237314|NCT00448968|"~     The purpose of this study is to determine if levels of ischemia modified albumin (IMA) in~     blood are elevated in patients with suspected infection and are predictive of severity of~     illness in patients with sepsis.~      In order to compare subjects with infection to those without infection who are representative~     of the ED population at each site, a group of non-infected control patients will be enrolled.~     Each hospital will enroll subjects with age (by decade) and sex matched controls to reflect~     the population of subjects suspected of infection.~   "
237315|NCT00448955|"~     Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in~     clinical practice and has significant effects on patient wellbeing. The purpose of this study~     is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy~     in testosterone deficient men.~   "
237316|NCT00448942|"~     The purpose of this study was to determine if the use of daily chlorhexidine bathing would~     decrease the incidence of MRSA and VRE colonization and healthcare associated Bloodstream~     Infections (BSI) among Intensive Care Unit (ICU) patients.~   "
237317|NCT00448929|"~     The purpose of this study is to compare the safety and effectiveness of trabeculectomy with~     ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without~     antifibrotic agents.~   "
237318|NCT00448916|"~     The study will evaluate the long-term safety and tolerability of pregabalin in pediatric~     patients, age 1 month through 16 years, with partial onset seizures.~   "
237319|NCT00448903|"~     Chronic foot ulcers are a common, severe and expensive complication in patients with diabetes~     and often causes lower-extremity amputation. The aim of this study is to evaluate the effect~     of bemiparin as treatment of diabetic foot ulcers.~   "
237320|NCT00448890|"~     GSK729327 is a selective positive allosteric modulator of AMPA-type ionotropic glutamate~     receptors, exhibiting equivalent potency at all AMPA receptor subtypes. On the basis of~     preclinical studies it is expected that this compound will improve cognitive measures in~     schizophrenic patients with acceptable safety. This is a First Time in Human Study (FTIH) to~     assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of~     GSK729327 in healthy volunteers. The study will be conducted in 2 parts, with single doses~     being explored in Part A and multiple doses over 28 days in Part B. Part A will be a single~     blind, placebo controlled, single oral dose, dose-rising cross-over study in healthy male~     volunteers. Subjects will be randomized into two cohorts with an alternate panel design.~     There will be up to nine dosing sessions in total in order to investigate up to 7 different~     doses. The initial dose will be 0.25 mg and subsequent doses will be determined based on the~     pharmacokinetic and safety results from the previous dose. Part B will be a randomised,~     single blind, placebo-controlled, parallel group study of repeat oral dosing of GSK729327. Up~     to 4 cohorts of 15 (12 subjects receiving active dose and 3 subjects receiving placebo)~     healthy male and females of (non-childbearing potential) volunteers will be enrolled in Part~     B.~   "
237321|NCT00448877|"~     The purpose of this study is to determine whether or not a new brain function monitor can~     distinguish between anesthetized and awake patients. The device implemented utilizes~     functional near-infrared (fNIR) technology to detect anesthesia depth as well as reaction to~     stimuli during surgical procedure.~      After obtaining consent the device is placed across the forehead of the patient. A baseline~     signal is obtained prior to induction. The fNIR signal is continuously recorded throughout~     the procedure. Key events as well as administration of drug are recorded in order to observe~     changes in the signal trend. Neither the device nor the light emitted is hazardous to the~     patient - no risks or discomforts are involved.~   "
237322|NCT00448864|"~     The primary objective of this study was to assess the efficacy and safety of 2 dose levels of~     ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as~     measured by chest tube drainage during the first 12 hours postoperatively or until the chest~     tube was removed, whichever came first, in patients undergoing primary coronary artery bypass~     grafting (CABG), single valve repair, or single valve replacement.~      The secondary objective was to compare the efficacy of all ecallantide-treated participants~     (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose~     ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody~     formation.~   "
237323|NCT00448851|"~     The purpose of this research study is to learn more about the effect of inhaled dust mite~     allergen extract on airway responses in allergic individuals with mild asthma. Information~     learned from this study will be used to identify a safe dose range of D Farinae extract for~     use in inhalation challenge studies. This study will also help determine how inhalation of~     the allergen affects mucociliary clearance (MCC) which is a measure of how quickly mucus~     clears from the airway.~   "
237324|NCT00448838|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth~     of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as~     gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving cetuximab together with~     combination chemotherapy may kill more tumor cells.~      PURPOSE: This clinical trial is studying how well giving cetuximab together with gemcitabine~     and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic~     cancer.~   "
237325|NCT00448825|"~     The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral~     Therapy for the treatment of alcohol and cocaine dependence.~   "
237326|NCT00448799|"~     The underlying goal of this study is to assess 123-I AV83 SPECT imaging as a tool to detect~     ß-amyloid deposition in the brain of AD research participants and age- and gender-matched~     healthy subjects.~   "
237327|NCT00448786|"~     The study involves the use of three different dosing regimens of AMG 706 in patients with~     advanced solid tumors to see how the drug affects the gallbladder size and function. The~     study will be conducted in 11 sites in the US and Australia. A total of 48 patients will be~     enrolled in the study with the possibility of enrolling 8 more in each treatment arm.~   "
237328|NCT00448773|"~     We will be testing the hypothesis whether online education for UC Berkeley students on~     respiratory hygiene, cough etiquette, hand hygiene/awareness, as well as face mask use (while~     ill) will reduce the acquisition and transmission of influenza-like illness. The study will~     be conducted during the flu seasons 2006-7 and 2007-8.~   "
237329|NCT00448760|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and~     leucovorin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     patients with previously untreated stage II or stage III esophageal cancer that can be~     removed by surgery.~   "
237330|NCT00448747|"~     The diagnosis of GH deficiency (GHD) in adults is established by laboratory testing in~     patients with an appropriate clinical history of hypothalamic pituitary disease. Two tests~     that are considered to be gold standard tests for the diagnosis of GHD are the insulin~     tolerance test (ITT) and GHRH combined with arginine. However, these tests are either~     bothersome (given intravenously) to the patient or are linked with side effects. Therefore,~     an orally available compound like AEZS-130(formerly ARD-07), if demonstrated to be safe and~     providing adequate sensitivity and specificity could be a welcome alternative and/or~     complement to the current available tests.~      The intent was to recruit 40 AGHD patients and 40 normal control subjects into this trial,~     but the original sponsor (Ardana Biosciences Ltd.) discontinued the study for financial~     reasons before this was completed. At the time of withdrawal of GHRH from the market in 2008,~     42 AGHD patients and 10 normal controls had completed the study at 9 US sites. This study is~     now being reactivated to complete the remaining 30 matched control subjects.~      Additionally upon agreement with the FDA in a SPA, 10 additional adult grown hormone~     deficient and their matched control will be enrolled into this trial for a total treated~     population approximatively 100 subjects.~   "
237331|NCT00448734|"~     This study will review the safety of picoplatin, a new type of platinum drug, with docetaxel,~     a drug commonly used in the treatment of prostate cancer. Patients who are eligible for this~     study will have had a diagnosis of hormone-refractory prostate cancer that has metastasized~     to other areas of the body, and have not been previously treated with chemotherapy drugs.~     Picoplatin will be administered in combination with docetaxel and prednisone to identify the~     maximum tolerated dose (MTD). Patients will receive IV treatments of picoplatin with~     docetaxel every 3 weeks, with prednisone, 5 mg orally, twice daily.~   "
237332|NCT00448721|"~     This is a single-arm phase II trial of perifosine in renal cancer patients who have~     experienced disease progression after receiving either sorafenib or sunitinib.~   "
237333|NCT00448708|"~     This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper~     extremity for hemodialysis access. All subjects will provide informed consent before~     undergoing any study procedures. The study will consist of multiple subject visits and~     telephone contacts during the 52 week study period. During the study period subjects must~     also maintain an appropriate hemodialysis schedule.~      IDE Number: G060250~   "
237334|NCT00448695|"~     The objective of this study is to establish the safety of MRI targeted laser thermal~     treatment for men with biopsy confirmed early stage low grade single sector prostate cancer.~   "
237335|NCT00448682|"~     RATIONALE: Drugs used in chemotherapy, such as floxuridine, leucovorin, oxaliplatin, and~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works as~     first-line therapy in treating patients with stage IV gastric cancer that cannot be removed~     by surgery.~   "
237336|NCT00448669|"~     This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral~     medicines) was safe for sexually-active young adults in Botswana without HIV infection and~     whether it reduced their risk of getting an HIV infection.~   "
237337|NCT00448656|"~     The purpose of this study is to determine the feasability of a new epicardial and minimal~     invasive ablation technique of the left atrium isolating the pulmonary veins for prevention~     of atrial fibrillation recurrences in patients with antiarrhythmic drug refractory lone~     atrial fibrillation.~   "
237338|NCT00448643|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also~     make tumor cells more sensitive to cisplatin. Giving radiation therapy together with~     cisplatin after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal~     radiation therapy when given together with cisplatin in treating patients with stage III or~     stage IV endometrial cancer that has been removed by surgery.~   "
237339|NCT00448630|"~     The purpose of the study is to find and follow-up the metabolic syndrome parameters on~     patients administering atypical antipsychotics.~   "
237340|NCT00448617|"~     This study will be a descriptive comparison of the effects of live attenuated influenza virus~     (FluMist) on nasal inflammation and oxidative stress in healthy young adults who are not~     exposed to smoke vs smokers. It is hypothesized that passive exposure to second-hand smoke~     (SHS) results in increased susceptibility to the effects of influenza virus in nasal~     epithelium in humans and that these effects are mediated by SHS-induced oxidative stress~   "
237341|NCT00448604|"~     The objectives of the study are~        -  to determine the prevalence of respiratory virus infections in COPD patients, during and~          outside acute exacerbation~        -  to explore the impact of these viral infections on the outcome of these patients~        -  to explore the association between blood procalcitonin levels and viral infections in~          this population.~   "
237342|NCT00448591|"~     This single arm study will assess the safety and efficacy of a regimen of Avastin plus a~     taxane, with or without additional chemotherapy, as first-line treatment in patients with~     locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv~     every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are~     contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal~     doxorubicin) may be used. The anticipated time on study treatment is until disease~     progression, and the target sample size is 500+ individuals.~   "
237343|NCT00448578|"~     This is a randomised, double blind, double dummy, multicentre, parallel-group study to~     compare the efficacy and safety of quetiapine and lithium used as monotherapy in the~     treatment of mania in patients hospitalised for an acute manic episode. After given of~     informed consent and undergoing screening procedures, the patients will be randomised into~     quetiapine or lithium group on Day 1. The efficacy of study treatment on symptoms of mania~     will be assessed at Day 28. Patients will not permitted to use any psychoactive or~     antipsychotic medications throughout the study period other than those expressly permitted by~     the protocol. The patients are required to be hospitalised for the treatment and assessment~     defined in the protocol. He/She could be discharged from the hospital after Week 2 (i.e. On~     Day 15) if the investigator believes that it will be clinical appropriate to discharge the~     patient, that the patient is not suicidal or homicidal, and that the patient could reasonably~     be expected to continue in the study on an outpatient basis. The patients discharged after~     Day 15 will be given sufficient study medication for the period from discharge to the next~     visit. At each centre, the same individual will administer a specific psychiatric assessment~     for a patient at all study visits in order to reduce variability in rating scale scoring.~     Before the initiation of the study, a consistency assessment will be done among the~     investigators who conduct the scale assessment in each centre.~   "
237344|NCT00448565|"~     The evidence-based approach to wean and consecutively extubate patients is based solely on~     objective criteria/tests. The introduction of subjective criteria could further improve the~     actual method.~   "
237345|NCT00448552|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving oxaliplatin together with~     capecitabine works in treating patients with relapsed or metastatic head and neck cancer.~   "
237346|NCT00448539|"~     This study is an open-label extension of Study E2080-A001-301. All patients will initiate the~     study at the total daily doses they were receiving at the end of the transition phase in~     E2080-A001-301 (2400 or 3200 mg/day) with an option, at the discretion of the Investigator,~     to incrementally increase doses to a maximum of 4800 mg/day. Safety variables and seizure~     frequency will be monitored throughout the study.~   "
237347|NCT00448526|"~     Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of~     progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are~     thus needed to arrest the progression of diabetic nephropathy. Although there is insufficient~     evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as~     a mainstay of nutritional management. We here assessed the role of low protein diet in renal~     function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of~     5 years.~   "
237348|NCT00448513|"~     The purpose of this study is to clarify the effects of tea catechin extracts on the frequency~     changes of micronuclei in peripheral lymphocytes compared with other oxidative stress markers~     in late middle aged healthy volunteers~   "
237349|NCT00448500|"~     This study aimed to assess airway inflammation in patients during the course of acute~     exacerbations of chronic obstructive pulmonary disease (AECOPD) by serial analyses of their~     exhaled breath condensates (EBC).~   "
237378|NCT00448123|"~     To determine if emergency department patients with acute ureteral colic pain due to a~     ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter~     time to passage of their stone or resolution of their pain. A secondary study objective will~     be to determine if there is a relationship between response to tamsulosin and stone size or~     position in the ureter.~   "
237350|NCT00448487|"~     3054 diabetic patients were screened for Haptoglobin Phenotype as part of the ICARE study~     (NCT00220831) and composite the I CARE Registry, 1434 Hp 2-2 patients were treated as part of~     the I CARE study with vitamin E vs. Placebo, this study was recently terminated due to~     significant differences between the groups and data was sent to publication. All other~     patients were passively followed since April 2005 for cardiovascular events. We have decided~     to continue and follow these patients till end of December 2007 to determine the incidence of~     CVD in theses patients which are pre stratified by Haptoglobin Phenotype.~   "
237351|NCT00448474|"~     The purpose of this study is twofold, to develop and test the effectiveness of a mailed~     arthritis self-management education intervention.~   "
237352|NCT00448461|"~     PROTOCOL SYNOPSIS Title: Comparison of bivalirudin and unfractioned heparin (UFH)+ protamine~     in elective percutaneous coronary interventions (PCI)~      Design: Prospective, randomized, controlled trial~      Hypothesis: Bivalirudin is superior to UFH + protamine for the improvement of outcomes in~     patients undergoing elective PCI~      Key Inclusion Criteria:~      Patients older than 18 years of age to undergo PCI Clopidogrel loading > 6 hrs prior to PCI~     according to the PCI guidelines Informed, written consent~      Key Exclusion Criteria:~      ST-elevation myocardial infarction within the prior 48 hours Active bleeding, bleeding~     diathesis, recent surgery Severe renal failure Chronic coronary artery occlusion to be~     treated~      Primary endpoint:~      Inhospital major bleeding~      Secondary endpoints:~        1. Composite rate of death, myocardial infarction (MI) or target vessel revascularization~          (TVR) inhospital, and at 6 months~        2. Composite rate of inhospital death, MI or TVR and major bleeding~        3. Major and minor bleedings~        4. Total vascular complications~        5. Post-procedure renal failure~      Randomization:~      Bivalirudin versus unfractioned heparin followed by protamine at the end of the PCI procedure~      Sample size:~      Assumed incidence of inhospital major bleeding of 6% in UFH + protamine and of 2% in~     bivalirudin group; for a power of 80% and a level of 0.05 for each group 425 patients are~     needed. An interim analysis will be performed after the enrolment of 425 (50%) patients.~      Follow-up:~      Inhospital, and 6-month clinical follow-up (out-patient clinic or by phone)~   "
237353|NCT00448448|"~     Adolescent idiopathic scoliosis (AIS) is a structural curve of the spine with no clear~     underlying cause. Bracing is currently the standard of care for preventing curve progression~     and treating AIS. However, the effectiveness of bracing remains unclear. The purpose of this~     study is to compare the risk of curve progression in adolescents with AIS who wear a brace~     versus those who do not and to determine whether there are reliable factors that can predict~     the usefulness of bracing for a particular individual with AIS.~   "
237354|NCT00448435|"~     To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison~     with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus~     fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.~      To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in~     paediatric patients with asthma.~   "
237355|NCT00448422|"~     The objective of this pivotal Phase III study is to investigate the safety and efficacy of~     prulifloxacin versus placebo in the treatment of patients with acute bacterial~     gastroenteritis (traveler's diarrhea.~   "
237356|NCT00448409|"~     To evaluate the efficacy and safety of Trovax and GM-CSF in patients with prostate cancer.~   "
237357|NCT00448396|"~     To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with~     advanced malignancies.~   "
237358|NCT00448383|"~     This is an open-label, multi-center study in which adalimumab (D2E7) is administered~     subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies.~     Patients must have active disease despite standard anti-rheumatic therapy.~   "
237359|NCT00448370|"~     The purpose of this research study is to find out whether Placenta Growth Factor (PlGF) and~     related tests can predict the development of acute chest syndrome (ACS) in patients with~     sickle cell disease (SCD) during a period where patients are well and during admission to the~     hospital for an acute sickle event to see if these measures can predict the development of~     ACS. Understanding events precipitating ACS may lead to preventative and interventional~     therapies which will improve patient outcomes and quality of life.~   "
237360|NCT00448357|"~     RATIONALE: Giving chemotherapy, such as fludarabine and busulfan, before a donor peripheral~     stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop~     the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted~     cells from a donor can make an immune response against the body's normal cells. Giving a~     monoclonal antibody, alemtuzumab, before the transplant and tacrolimus after the transplant~     may stop this from happening.~      PURPOSE: The phase I portion of this trial identified the maximum tolerated dose of busulfan~     after treating 40 patients on a dose-escalation scheme. We are now treating an additional 26~     patients on the phase II portion of the trial at a Pharmacokinetic (PK)-directed dose of~     total area under curve (AUC) 6912 micrometer (uM)-min/24 hours. We transitioned to the Phase~     II portion of the study in October 2009.~   "
237361|NCT00448344|"~     The overarching aim of the study is to evaluate in a randomized trial the impact of a~     family-supported intervention compared to a standard veteran-focused telephone counseling~     control group to promote smoking cessation among cancer and heart disease patients.~   "
237362|NCT00448331|"~     The purpose of this study is to find out how prevalent unidentified Mental Health issues are~     in the pediatric population that visits the Emergency Department in an urban city.~   "
237377|NCT00448136|"~     This 2 arm study will assess the efficacy and safety of two systemic treatments including~     Avastin in patients with previously-untreated progressive locally advanced/metastatic~     well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm~     1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin~     500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks.~     Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po~     bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated~     with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or~     unacceptable toxicity. The anticipated time on study treatment is until disease progression~     or unacceptable toxicity, and the target sample size is <100 individuals.~   "
237363|NCT00448318|"~     Dementing syndromes are, for the most part, incurable. People with dementia become highly~     dependent and frequently have to move from their homes into residential aged care facilities.~      Medications aimed at reducing the severity of a number of symptoms associated with the~     different types of dementia have had only modest success.~      Increasingly, people with dementia, their families and carers are turning to supplementary or~     alternative approaches to the management of their symptoms. There are many published reports~     describing the successful use of music therapy in reducing the severity of many symptoms of~     dementia. These include reports of improved memory, improved language skills, reduced anxiety~     and depression, reductions in agitation and disruptive behaviours and better social~     relationships with family, peers and carers. However, the quality of evidence they provide~     for the most part fails meet the standards of evidence required by health care providers.~     This clinical trial will examine the effects of a music therapy intervention.~      The study will recruit 180 patients in sub-acute hospital wards. Participants will be~     randomly placed in groups that receive either occupational therapy or music therapy. Before~     the therapy programs begin, we will use questionnaires to measure memory function, language~     ability, orientation and mood. We will also record brain activity from the surface of the~     scalp, blood pressure and pulse to examine physiological responses. The same measures will be~     repeated after the 3 weeks of therapy to determine whether there has been any improvement in~     the symptoms of the participants and whether the group that had music therapy showed greater~     improvement than the group that had occupational therapy. We will make a video recording~     during one therapy session to allow us to observe levels of engagement and to assess changes~     in facial expressions. This will provide information about the immediate effects of music on~     mood and social interaction. The information we collect about brain activity and blood~     pressure will help us to understand how music therapy might bring about changes in the~     symptoms of dementia. This understanding will be useful in developing better applications of~     music therapy. It will also add to our current knowledge about how the various diseases cause~     the problems they do.~      In summary, the primary aim of the project is to determine whether the reported effects of~     music therapy are supported by objective evidence.~   "
237364|NCT00448305|"~     The purpose of this study is to assess the efficacy, safety and tolerability of a therapy~     with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for~     patients with relapsed or metastatic triple receptor negative breast cancer (a special~     subgroup of breast cancer).~   "
237365|NCT00448292|"~     The purpose of this randomized, double-blind, placebo-controlled study is to assess the~     safety and efficacy of PRX-00023 in patients with major depressive disorder.~   "
237366|NCT00448279|"~     This 2 arm study will compare the efficacy and safety of continuation or discontinuation of~     Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive~     metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus~     Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment~     (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line~     chemotherapy of the investigator's choice. The anticipated time on study treatment is until~     disease progression, and the target sample size is 100-500 individuals.~   "
237367|NCT00448266|"~     This phase II/III trial will investigate the ability of chemotherapy with 'Intensified~     Aklylating Agents (IAA) to achieve a high pathological complete response (pCR) rate when~     employed in the preoperative chemotherapy of breast cancer with evidence of a Homologous~     Recomination Deficiency (HRD).~   "
237368|NCT00448253|"~     The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420~     or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse~     events and laboratory assessments. To determine the dose proportionality relation of three~     different doses of NP-015.~   "
237369|NCT00448240|"~     The purpose of this study is to determine if combination Erlotinib, Cisplatin/Carboplatin,~     and Paclitaxel are effective first line treatment for metastatic, recurrent and persistent~     squamous cell carcinoma of the head and neck.~   "
237370|NCT00448227|"~     This study will evaluate the acceptability and safety of famciclovir in infants with herpes~     simplex infection~   "
237371|NCT00448214|"~     To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial~     fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics~     (anti-thrombotic potential) in the target population~   "
237372|NCT00448201|"~     RATIONALE: Giving low doses of chemotherapy, such as busulfan and fludarabine, before a donor~     stem cell transplant helps stop the growth of cancer and abnormal cells. It also helps stop~     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer or abnormal cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Immunosuppressive therapy may improve bone~     marrow function and may be an effective treatment for hematologic cancer or other disease.~      PURPOSE: This clinical trial is studying the side effects and how well giving busulfan and~     fludarabine with or without antithymocyte globulin followed by donor stem cell transplant~     works in treating patients with hematologic cancer or other disease.~   "
237373|NCT00448188|"~     Since many of the patients in an intensive care unit suffer from disorders of hemostasis,~     bleeding is a main concern applying central venous catheters. Even if there are some data~     indicating elevated international normalized ratio may not increase the risk of bleeding no~     clear cut-off has been defined so far. An INR > 1.5 is generally considered to increase the~     risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a~     contra-indication to CVC cannulation, since there are some data this may increase the risk of~     bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical~     experience INR > 1.5 and platelets < 50 x 109 /l do not correlate with increased risk of~     bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and~     platelet count, is not decisive for bleeding.~   "
237374|NCT00448175|"~     The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug~     therapy for the treatment of symptoms of overactive bladder (OAB).~   "
237375|NCT00448162|"~     The variations of ENaC have an impact on the degradation of epithelial sodium channels and~     sodium reabsorption, and thus are associated with hypertension and hypokalemia.~      Liddle's syndrome is a rare monogenic form of autosomal-dominant hypertension caused by~     truncating or missense mutations in the C-termini of epithelial sodium channel β- or~     γ-subunit encoded by SCNN1B or SCNN1G. Our purpose is to determine the hotspot of mutation~     causing Chinese Liddle's syndrome.~      The second purpose is to determine wether the polymorphisms of ENaC are associated with~     hypertension in Chinese. Some polymorphisms of ENaC associated with hypertension may be~     genetic risk factors for Chinese hypertension.~   "
237376|NCT00448149|"~     The purpose of this study is to see whether the combination for RAD001 and Nexavar® works~     better when given together than they do alone. The purpose of the first phase of this study~     is to determine the best dose of RAD001 given with Nexavar®, and to see what effects, good~     and/or bad, the study drug has on the subject and the subject's tumor. This study will also~     observe side effects experienced by the subject.~   "
237380|NCT00448097|"~     The purpose of this study is to differentiate between the administrations of Cetuximab alone~     vs. Cetuximab plus Docetaxel in the treatment of non-metastatic prostate cancer before the~     surgical removal of the prostate.~   "
237381|NCT00448084|"~     This study will use functional MRI (fMRI, a technique that shows what areas of the brain are~     active when performing different mental tasks), to examine how the brain in people with~     functional movement disorders (FMD) may differ from that in people without FMDs. People with~     FMD have movement symptoms they feel they cannot control and that are not due to a known~     medical disorder. Previous studies looking at the brain activity of FMD patients have found~     areas in the frontal lobe of the brain that appeared overactive. These overactive areas may~     make it difficult to perform complex mental tasks. Studying the brain during performance of~     these tasks may enhance knowledge about FMD.~      Patients 18 years of age or older with an FMD and healthy normal volunteers may be eligible~     for this study. Participants have two visits to the NIH Clinical Center for the following~     procedures:~      First visit (screening):~        -  Medical history and neurological examination.~        -  Urine drug screen for illicit drugs.~        -  Psychological testing, including an interview and questionnaires.~      Second visit:~        -  Brain MRI (if one has not been done at NIH within the past 12 months): MRI uses a~          magnetic field and radio waves to produce images of body tissues and organs. The subject~          lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing~          earplugs to muffle loud noises that occur during the scanning process. The procedure~          lasts about 2 hours, during which time the patient is asked to lie still for up to 30~          minutes at a time.~        -  Brain fMRI: While in the MRI scanner, subjects read questions and answer them yes or no~          by pushing buttons. They are asked to answer questions about their health, their~          movement symptoms and unrelated topics (like personal preferences and current events).~          The questions vary in difficulty. Sometimes subjects are instructed to answer correctly;~          other times they are asked to answer incorrectly. A strap is placed around the subject's~          chest and two wires are taped to the fingers to monitor heart rate, breathing rate and~          sweat response during the scan. The scan takes about 2 hours.~   "
237382|NCT00448071|"~     MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent~     Intra dialytic Hypotension~   "
237383|NCT00448058|"~     To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the~     treatment of outpatient subjects with Major Depressive Disorder (MDD)~   "
237384|NCT00448045|"~     It is known that individuals with spinal cord injury are at increased risk for respiratory~     tract infections like pneumonia. Part of this risk is due to weakened chest and abdominal~     muscles that are vital to deep breathing and the ability to cough. The purpose of this study~     is to look at the effectiveness of two different treatments in preventing pneumonia and other~     respiratory problems in persons with SCI.~      This is a randomized controlled trial investigating the effectiveness of two different~     treatments. Participants will be randomly assigned to one of the two treatment groups. They~     will not be told the details of the other intervention since this could influence or change~     their activities during the study.~   "
237385|NCT00448032|"~     A study evaluating the safety and pharmacokinetics of multiple oral doses of an~     investigational oral diabetic agent when given to healthy Japanese male volunteers.~   "
237386|NCT00448019|"~     The goal of this clinical research study is to learn if the combination of fludarabine,~     cyclophosphamide, rituximab, and bevacizumab is effective in treating chronic lymphocytic~     leukemia in patients who have already been treated with chemotherapy. The safety of this~     treatment will also be studied.~   "
237387|NCT00448006|"~     The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent~     in malignant obstructions of the common bile duct.~   "
237388|NCT00447993|"~     The purpose of this study is to look at the safety and effectiveness of CNTF implants on~     vision in persons with retinitis pigmentosa, Usher type II & III, and Choroideremia. This~     research is being done because there are no effective therapies for people with these retinal~     degenerations. They are genetic disorders that affect our ability to see at night, and later~     cause tunnel vision and loss of central vision. Retinal degenerations affect the retina, a~     light sensitive layer of cells in the back of the eye. Slowly over time, these cells die and~     cause permanent loss of vision.~      The implant is a small capsule that contains human retinal pigment epithelium cells. These~     cells have been given the ability to make CNTF and release it through the capsule membrane~     into the surrounding fluid. This study will look at the effect of the implant on vision loss~     by retinitis pigmentosa, Usher type II & III, and Choroideremia. In this study, two different~     CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (or~     placebo) surgery in the other eye.~   "
237389|NCT00447980|"~     The purpose of this study is to look at the safety and effectiveness of CNTF implants on~     vision in persons with retinitis pigmentosa, Usher type II & III, and Choroideremia. This~     research is being done because there are no effective therapies for people with these retinal~     degenerations. They are genetic disorders that affect one's ability to see at night, and~     later cause tunnel vision and loss of central vision. Retinal degenerations affect the~     retina, a light sensitive layer of cells in the back of the eye. Slowly over time, these~     cells die and cause permanent loss of vision.~      The implant is a small capsule that contains human retinal pigment epithelium cells. These~     cells have been given the ability to make CNTF and release it through the capsule membrane~     into the surrounding fluid. In this study, two different CNTF dose levels will be used: a~     high dose and a low dose in one eye, as well as a sham (or placebo) surgery in the other eye.~   "
237390|NCT00447967|"~     This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan~     and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with~     locally advanced or metastatic gastric cancer~   "
237391|NCT00447954|"~     The purpose of this study is to look at the safety and effectiveness of CNTF implants on~     vision in participants with atrophic macular degeneration. This research is being done~     because there are no effective therapies for people with atrophic macular degeneration.~     Age-related macular degeneration (AMD) is a condition that affects the macula, the central~     part of the retina that we use for seeing details. There are two types of AMD, one is the wet~     type in which new blood vessels grow, also known as choroidal neovascularization (CNV), but~     the other is the dry type in which the healthy cells die, and that is the target of this~     study. This is called atrophic macular degeneration. The implant is a small capsule that~     contains human retinal pigment epithelium cells. These cells have been given the ability to~     make CNTF and release it through the capsule membrane into the surrounding fluid. In this~     study, two different CNTF dose levels will be used: a high dose and a low dose, as well as a~     sham surgery (or placebo) group.~   "
237392|NCT00447941|"~     Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of~     SCA-136 in healthy male Japanese subjects~   "
237393|NCT00447928|"~     The purpose of the study is to evaluate the effectiveness and safety of the use of low-dose~     nitroglycerin transdermal patches to treat pain and function in chronic tennis elbow.~   "
237394|NCT00447915|"~     To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to~     patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by~     oral administration every day. To evaluate also the dose response of R484iv.~   "
237395|NCT00447902|"~     The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV~     or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI)~     experienced, with documented resistance to more than one PI. Determine pharmacokinetic data~     in this co-infected population and potential utility of using therapeutic drug monitoring~     (TDM) in improving efficacy outcomes.~   "
237396|NCT00447889|"~     This is a clinical study of gadoteric acid in non-coronary MR angiography.~   "
237397|NCT00447876|"~     This study will investigate the hypothesis that the analgesic effect of a single injection of~     Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar~     fasciitis.~   "
237398|NCT00447863|"~     Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed~     as an oral contraceptive (birth control pill). The purpose of this trial is to compare~     different preparations of LNG/EE by assessing the way they are absorbed into the blood.~   "
237399|NCT00447850|"~     Previous studies have suggested that premature luteinization (PL)during controlled ovarian~     stimulation (COS) decreases the implantation rate due to a negative effect on the endometrium~     receptivity. This study aims to describe the impact on endometrial gene expression of PL in~     GnRH antagonist and GnRH agonist cycles.~   "
237400|NCT00447837|"~     The primary objective of the study is to evaluate the safety and efficacy of SPRC-AB01 versus~     placebo for treatment of chronic sinusitis in subjects who have had sinus surgery.~   "
237401|NCT00447824|"~     Hypothesis:~        1. May the introduction of NIDCAP during blood sample reduced pain in neonates during blood~          sample~        2. Compare the effect of venous and capillary blood sample method~   "
237402|NCT00447811|"~     This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics~     of MOA-728 in subjects on stable methadone maintenance.~   "
237403|NCT00447798|"~     The proposed study uses a two-arm randomized experimental design to evaluate the efficacy of~     a brief, theoretically-guided, Prevention Care Advocate intervention with HIV-positive~     crack users. Study participants will be recruited from the HIV inpatient hospital wards of~     two inner-city hospitals that serve a similar population of HIV-positive patients: Jackson~     Memorial Hospital (JMH) in Miami, Florida and Grady Memorial Hospital (GMH) in Atlanta,~     Georgia.~   "
237404|NCT00447785|"~     This study is about the endocrine regulation of energy and fluid supplies in alcoholic~     patients. A large proportion of energy and fluid is supplied by alcohol beverages in~     alcoholic patients. In this study, we evaluated the importance of these supplies with a~     detailed questionnaire, a nutrition software that evaluated the importance of each macro- and~     micronutrients and correlated these values with several hormones such as Leptin, Insulin,~     Cortisol, Ghrelin, and PYY involved in the regulation of energy balance or AVP involved in~     the regulation of plasma osmolality~   "
237405|NCT00447772|"~     The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most~     frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly~     laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be~     assigned to one of the two basic types of cervical dystonia, either predominantly rotational~     torticollis or predominantly laterocollis on the basis of clinical examination. This will~     determine which therapy is to be administered, using the clearly defined, structured~     injection protocols.~   "
237406|NCT00447759|"~     The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamline safety study~     designed to compare the cardiovascular safety of celecoxib versus traditional non-selective~     Non Steroidal Anti-Inflammatory Drug (NSAID) therapy.Traditional NSAID's are associated with~     significant morbidity and mortality from gastrointestinal toxicity. Cyclooxygenase 2~     (Cox-2)selective agents are associated with reduced upper gastrointestinal~     toxicity.Traditional NSAID's and Cox-2 inhibitors may also be associated with cardiovascular~     and renal disorders. Data from both randomised and observational studies suggest that~     celecoxib has similar or reduced cardiovascular toxicity when compared to traditional~     NSAID's. However, the overall safety balance of a strategy of celecoxib therapy versus a~     strategy of NSAID therapy is unknown. The European Medicines Evaluation Agency (EMEA) has~     requested that studies of the cardiovascular safety of celecoxib be carried out within the~     indicated population of Europe. This study addresses these issues by comparing the~     cardiovascular safety of celecoxib therapy with traditional NSAID therapy in the setting of~     the EU healthcare system.~      As of May 2013, 7300 patients had been randomised, and had accrued an average 4.2 years of~     follow up by the end of May 2014.~   "
237407|NCT00447746|"~     Gastric cancer remains the second most common cancer worldwide.Although the prognosis is poor~     for majority of patients , long term survival is achievable in patients in whom surgical~     resection is possible.~      However the results of surgery are generally disapointing in most large series.The exception~     to this appears to be Japan and far east where a standardized approach to surgery is~     undertaken with low morbidity and mortality.The extent of surgery and particularly the~     development of systematic lymphadenectomy(D2)has been credited in Japan for the improved~     outcome in patients with gastric cancer.~      Hence for comparing the difference between D1 and D2 lymphadenectomy for gastric cancer in~     terms of overall survival,disease free survival and loco regional recurrence and also post~     operative morbidity and mortality following both these procedures,this study has been~     undertaken.~      In D1 lymphadenectomy, only those lymph nodes which are adjacent to the part of stomach being~     resected will be removed.In D2 lymphadenectomy other lymph nodes draining the stomach will~     also be removed according to internationally accepted guidelines and also include resection~     of greater omentum along with anterior layer of transverse mesocolon and lesser omentum upto~     its attachment to hepatoduodenal ligament.~      Currently both these procedures are widely practised worldwide and there is no definite~     evidence showing the superiority of one procedure over the other.Neither is any of these~     procedures experimental.~      We are doing this trial to see whether one of these procedures is superior to the other.~   "
237408|NCT00447733|"~     The purpose of this study is to determine whether Integrated Treatment is effective in the~     treatment of anxiety and/or depression with co-occurring substance use disorders.~   "
237409|NCT00447720|"~     This study seeks to examine the effectiveness of translating two proven interventions,~     RESPECT, and the NIDA Community Based Outreach Model, into one program of education, PATH, to~     be delivered by case managers to their seriously mentally ill, substance abusing clients.~      The objective is to teach case managers to assess the specific risk profiles of their~     clients, and then create a plan of intervention aimed at reducing high risk sexual and~     substance abusing behaviors.~   "
237410|NCT00447707|"~     This is a randomized, controlled trial of Positive Choice, an interactive multimedia computer~     program, to determine whether it can detect and reduce risky behaviors among HIV-positive~     adults. The behaviors of interest are: unprotected anal or vaginal intercourse, illicit drug~     use, risky alcohol drinking, and failure to disclose HIV status to sex partners. The Positive~     Choice program is integrated into the routine operations of outpatient HIV clinics, where~     participating patients complete an in-depth risk assessment (computerized health~     questionnaire) before a regularly scheduled medical appointment. Participants assigned to the~     intervention arm receive brief, interactive risk-reduction counseling by an actor-portrayed~     Video Doctor and an educational worksheet. Their health care provider receives as summary~     cueing sheet, alerting them to the patient's risky behavior and readiness to change. Control~     participants complete the computerized risk assessment and receive the clinic's usual care.~     Three months after a baseline visit, intervention and control group patients are invited back~     to complete an additional risk assessment. The intervention group also receives a booster~     intervention. Six months after baseline, both groups complete a final risk assessment.~   "
237411|NCT00447694|"~     The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in~     beta-thalassemia patients with deferasirox treatment.~   "
237412|NCT00447681|"~     This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group~     study of ascending single IV doses of ILV-094, an investigational drug, administered to~     healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow~     the 25 mg IV dose.~   "
237413|NCT00447668|"~     This study will compare the effectiveness of yoga classes, exercise classes, and a self-care~     book in the management of pain and function for people with low back pain.It will also for~     physical, psychological and physiological factors associated with improvement in back pain.~   "
237414|NCT00447655|"~     Limb loss can result from a variety of etiologies including diabetes, trauma and cancer.~     Following limb loss, individuals are at elevated risk for activity limitations and~     participation restrictions with significant impact on health and quality of life.~     Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and~     established the effectiveness of a self-management program (PALS) to improve health and~     outcomes following limb loss. Literature suggests that the access to, and effectiveness and~     utilization of, this class of interventions may be enhanced by the concerted use of early~     intervention, peer mentorship, motivational interviewing and provider training. Objectives:~     Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention-~     PALS Plus. The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention~     in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS~     Plus intervention in maximizing utilization of self-management interventions for persons with~     limb loss. A cohort of 200 patients will be enrolled prior to implementation of the~     intervention and will serve as the control group. Subsequently, a second cohort of 200~     patients will be enrolled and receive the PALS Plus intervention and will serve as the~     intervention group. Assessment will be at baseline, treatment completion and six month~     follow-up. Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood.~     Secondary outcome measures are: function, participation and bothersomeness of limitations.~     The investigation will also provide unique and valuable information regarding patients'~     acceptance and use of peer visitation and self-management following limb loss. Relevance: By~     establishing the utility and effectiveness of the enhanced self-management intervention,~     there is the potential to improve the health, activity, participation and quality of life for~     individuals with disabilities. The intervention addresses the areas of activity and~     participation in such a way that it can be implemented in local health care facilities~     working in combination with a national consumer based organization - the Amputee Coalition of~     America.~   "
237415|NCT00447642|"~     This study will evaluate the use of LX201 to prevent future graft rejection episodes and/or~     graft failure in patients who have undergone corneal transplantation and who have recently~     experienced a rejection episode due to an immune response.~   "
237416|NCT00447629|"~     A study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of~     the heart.~   "
237417|NCT00447616|"~     The purpose of establishing the database is to evaluate the effects of surgical removal of~     the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall~     health.~   "
237418|NCT00447603|"~     The purpose of this study is to test the safety and effectiveness of Losartan as compared to~     Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.~   "
237419|NCT00447590|"~     The purpose of this study is to determine whether the LAP-BAND system is safe and effective~     in morbidly obese adolescents.~   "
237420|NCT00447577|"~     The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in~     the treatment of ocular inflammation associated with blepharokeratoconjunctivitis~   "
237421|NCT00447564|"~     Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral~     tablets, patients experience withdrawal and cravings when the variable BPN levels in the~     blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is~     designed to provide 6 months of stable BPN blood levels. This study will test the safety and~     efficacy of Probuphine in the treatment of patients with opioid dependence.~   "
237422|NCT00447551|"~     Primary objective To evaluate the degree of correction achievable with Sculptra for~     nasolabial folds, mid- and lower facial volume loss, jawline laxity and other signs of facial~     ageing.~      To document the types and incidence of device-related adverse events with Sculptra.~   "
237423|NCT00447538|"~     The project utilize experience and knowledge gained from previous early childhood projects in~     NYC post 9/11 and Sderot. The overall goals are:~        1. Identifying young children (under 6 years old) and their parents who are suffering from~          posttraumatic distress in the aftermath of the continuing conflict on Gaza border,~          Israel.~        2. Increasing the capacity of local institutions to treat toddlers and families at risk.~        3. Providing resilience -building services that strengthen the coping abilities of families~          and caregivers in response to continual terrorism.~   "
237424|NCT00447525|"~     Primary objective:~      To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second~     booster to healthy 6 year-old children .~      Secondary objectives:~        -  Additional immunogenicity assessments.~        -  To describe the safety profile of a single dose of REVAXIS® or DT-Polio®~   "
237447|NCT00447213|"~     The purpose of the study is to compare the human insulin inhalation powder plus insulin~     glargine with injected insulin (regular human insulin or insulin lispro) plus insulin~     glargine on lowering the blood sugar level.~   "
237425|NCT00447512|"~     Ghrelin, an acylated peptide consisting of 28 amino acids, is the endogenous ligand of the~     growth hormone secretagogue receptor (GHS-R). It is synthesized predominantly in the stomach~     but has been also identified in a variety of other organs. Alike, a wide range of central and~     peripheral endocrine and non-endocrine actions has been described, e. g. being a releasing~     factor of growth hormone, prolactin and ACTH, a modulator of cell proliferation and~     apoptosis, a regulator of sleep-wake regulation, and a orexigenic hormone. Aims of this study~     are:~      A) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the~     hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the~     hypothalamic-pituitary-gonadal axis in healthy subjects of both genders (age groups: 20-30,~     35-45, 60-70 years).~      B) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the~     HPA axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in patients with~     major depression (age range: 20-65 years).~   "
237426|NCT00447499|"~     The purpose of this study is to determine whether subjects with acromegaly (or their~     partners) are able to self administer Somatuline Autogel at home.~   "
237427|NCT00447486|"~     The purpose of this study is to determine whether GW842166 is effective in the treatment of~     osteoarthritis pain of the knee.~   "
237428|NCT00447473|"~     This trial represents an attempt to offer second line immunotherapy plus chemotherapy to~     patients who have failed prior taxane base therapy.~   "
237429|NCT00447460|"~     Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the~     treatment of patients who have developed a GVHD refractory to the usual therapeutic measures~     after undergoing an allogenic hematopoietic stem cell transplant.~   "
237430|NCT00447434|"~     Nattokinase is a potent fibrinolytic enzyme extracted from Natto. The objective of this study~     was to compare the efficacy of the natto extract taken by healthy volunteers, dialysis~     patients, and patients with cardiovascularrisk factors on the fibrinolytic factors and blood~     lipids. The study has two primary objectives: to evaluate the effect of oral intake of~     nattokinase in normal subjects, patients under dialysis, and patients of cardiovascular high~     risk group, and to compare the effect of oral intake of nattokinase among three groups.~      Fifteen subjects, 20-70 years, for each group will be enrolled to take the capsules of natto~     extract orally for 2 months. Fibrinolytic factors, vital signs and blood lipids for efficacy,~     and body weight, renal function and self-administered questionnaire for safety will be~     assessed at screening, 3, 7, 28, and 56 days after the initiation of intake, and 2 weeks~     after the cease of intake.~   "
237431|NCT00447421|"~     The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and~     radiotherapy in the treatment of patients with Small Cell Lung Cancer.~   "
237432|NCT00447408|"~     With this study the investigators will test, in a randomised clinical trial (RCT), the~     efficacy of a behavioral dietary adherence enhancement intervention paired with PDA-based~     dietary self-monitoring for controlling sodium intake. Seventy hemodialysis patients will be~     recruited from units in Pittsburgh, Pennsylvania. Participants will be randomized to a~     4-month PDA-based dietary counseling intervention or to a 4-month attention control.~     Potential participants will be stratified by whether or not they have diabetes. Data on~     primary and secondary outcomes will be obtained at baseline and four months. Primary~     dependent variables are:~        1. adherence to dietary sodium targets as assessed from 3-day food recalls,~        2. average monthly interdialytic weight gain, and~        3. average pulse pressure. Secondary dependent variables are:~        4. adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats,~          potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and~          phosphorus levels determined on a monthly basis, and (6) nutritional status as~          determined from serum albumin. Laboratory data, interdialytic weight gain, and blood~          pressure data will be obtained per dialysis center routine and abstracted from the~          medical record. Three-day food recalls will be obtained at baseline, 4 and 8 months and~          analyzed using the Nutrient Data System.~   "
237433|NCT00447395|"~     In recurrent miscarriage, the male factor has been poorly evaluated. In fact, in the vast~     majority of clinical protocols of recurrent miscarriage, the sperm is not considered or~     assessed. Recently, some studies have suggested the presence of genetic and metabolic sperm~     anomalies in couples suffering from repeated miscarriages. Specifically, DNA fragmentation~     and altered oxidative stress in the sperm and Y microdeletions from blood samples have been~     related to an increased risk of miscarriage.The aim of the present study is to compare these~     three parameters in: couples with recurrent miscarriage; oligozoospermic men with or without~     recurrent miscarriages; and healthy sperm donors, in order to determine their actual impact~     on this reproductive problem.~   "
237434|NCT00447382|"~     The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and~     South Africa. The aim of this trial was to make a safety comparison of insulin detemir~     produced by a new production method (NN729) with insulin detemir made by the previous~     production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks~     at the same total daily dose and frequency of administration as their own pre-trial basal~     insulin . During the trial doses were individualised based on subject's plasma glucose~     measurements.~   "
237435|NCT00447369|"~     The purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison~     with sodium valproate in migraine prevention with a randomized blinded crossover study.~   "
237436|NCT00447356|"~     This randomized phase III trial is studying high dose interferon alfa to see how well it~     works compared to observation only in treating patients with stage II or stage III melanoma~     that has been completely removed by surgery.~   "
237448|NCT00447200|"~     We would like to investigate the natural variation in the strokevolume of the heart. At the~     same time we would like to find out the minimal number of heart cycles necessary to discover~     a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal~     Doppler.~   "
237449|NCT00447187|"~     This was a pivotal trial to determine whether LX201 reduces the likelihood of a graft~     rejection episode following corneal transplantation in patients at high immunological risk~     for rejection.~   "
237507|NCT00446433|"~     A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate~     the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults with Moderately~     Severe Crohn's Disease~   "
237437|NCT00447343|"~     Decompressive surgery to relieve symptoms of spinal cord compression due to dysfunction, such~     as arthritis, has proved variable in success. Past research has reported that approximately~     one-third of surgery patients improved, one-third remained the same and one-third worsened.~     Currently, there are no reliable tests that can predict the outcome following surgery. We are~     hoping that this study will change that.~      Using functional MRI (fMRI), we wish to investigate the relationship between clinical~     symptoms and the recovery of brain activation following surgery. One can also track the~     concentrations of different chemicals (metabolites) by using magnetic resonance spectroscopy~     (MRS). We hypothesize that the recovery of normal brain activation patterns will coincide~     with clinical improvement. Our objective in this study is to explore the potential role of~     fMRI as a tool to prognose patients with cervical myelopathy.~      Twenty-five patients with cervical myelopathy will be imaged using a high-powered (3 Tesla)~     fMRI scanner before and six months following surgery. In addition, ten healthy controls will~     be imaged to provide a baseline measure. Both the patient and control groups will complete~     questionnaires at the time of their scans. These will provide information concerning the~     subjective experience of the individuals throughout recovery. We will compare brain~     activation patterns of control and patient groups to investigate how the brain heals~     following decompressive surgery.~   "
237438|NCT00447330|"~     The purpose of this study is to evaluate the progression free survival of capecitabine~     (Xeloda), oxaliplatin and bevacizumab (Avastin) in previously untreated metastatic~     esophagogastric adenocarcinomas.~   "
237439|NCT00447317|"~     This randomized study will pilot test an intervention, based on self-efficacy theory and~     involving personal digital assistant (PDA)-based dietary self-monitoring, to improve~     adherence to the peritoneal dialysis dietary regimen. 60 individuals, 21 years of age or~     older, who are on continuous ambulatory peritoneal dialysis or nightly cycler peritoneal~     dialysis, will be recruited to the study. Participants will be randomized to one of 2 groups.~     Group A will receive a 4-month active intervention of decreasing intensity over time~     delivered via mail, telephone, and during regularly scheduled dialysis clinic visits. Group B~     will receive a 4-month attention control experience in which they receive reinforcement of~     standard dietary education. With this study the investigators will:~        1. Explore the impact of the intervention on dietary sodium intake,~        2. Explore the intervention on blood pressure,~        3. Explore the impact of the intervention on morning post dialysis weight (i.e. weight~          after conclusion of continuous cycling peritoneal dialysis (CCPD) or after long dwell~          for continuous ambulatory peritoneal dialysis (CAPD) patients, AND~        4. Explore the feasibility and acceptability of the intervention~   "
237440|NCT00447304|"~     Acute cholecystitis is frequent in the elderly, or in patients with gall stones. Most cases~     of severe or recurrent cholecystitis need surgery as final therapy. Today, the performed~     procedure in most cases for cholecystectomy in the western world is laparoscopic~     cholecystectomy. Only in some cases an open surgery has to be performed. Unclear is, what~     time point is best, concerning outcome and morbidity of the patient, immediate surgery or~     initial conservative therapy using antibiotics and symptomatic therapy with cholecystectomy~     later on. Today the performed procedure is mainly chosen by the fact, what doctor sees the~     patient first, surgeon or gastroenterologist. This study is performed to evaluate if one~     therapy is superior.~   "
237441|NCT00447291|"~     Children with an excess in body weight, increase the risk of obesity-related co-morbidities~     and cardiovascular diseases. Childhood obesity may be due to diets laden with fat and lack of~     physical activity. Omega-3 fish oil is a supplementation that may promote a greater reduction~     of pro-inflammatory mediators; combined with exercise and nutritional regimens it may also~     help improve glycemic, lipid markers, and body composition in overweight children and~     adolescents.~   "
237442|NCT00447278|"~     The purpose of this study is to demonstrate that atomoxetine is superior to other early~     standard therapy (any treatment that investigator considers is appropriate to initiate for~     the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term~     functioning in approximately 400 children and adolescents with ADHD. Patients will be~     pharmacological naïve prior to entry into the study.~   "
237443|NCT00447265|"~     Systemic lupus erythematosus (SLE) is a chronic, multisystem, autoimmune disease in which the~     body's immune system attacks its own normal tissues. This abnormal autoimmune response can~     result in damage to many parts of the body, including the skin, joints, lungs, heart, brain,~     intestines, and kidneys. Kidney problems occur in 60-75 % of lupus patients. The development~     of lupus-related kidney disease (called lupus nephritis) is associated with an overall worse~     prognosis.~      SLE is usually treated with drugs that try to block inflammation caused by the immune system.~     These treatments can create their own problems and they do not cure lupus. The drugs that are~     often used to treat lupus nephritis include prednisone (steroids), cyclophosphamide~     (Cytoxan), azathioprine (AZA or Imuran), and mycophenolate mofetil (MMF or Cellcept). The~     main purpose of this study is to evaluate the safety and tolerability of etanercept compared~     to placebo in combination with standard of care to treat individuals with active lupus~     nephritis.~   "
237444|NCT00447252|"~     The present study will focus on several objectives in the framework of the family perspective~     and systemic understanding of the mourning process:~        1. Identification of the psychological, social and practical needs of families that have~          lost a child to terrorism.~        2. Deepening and extending the knowledge of how families cope with the loss of a child in a~          violent incident of a security-related nature.~        3. Identification of risk and resilience factors within the family structure, and the~          nature of the relationships within the family.~   "
237445|NCT00447239|"~     Aim. To determine whether the maintenance of normoglycemia decreases the incidence of~     ventilator associated pneumonia (VAP), reduces its treatment period and the length of stay in~     the intensive care unit.~      Methods. Prospective, randomized, controlled trial. We enrolled 117 mechanically ventilated~     trauma (71) and abdominal (46) surgical patients, older than 18, of both sex. In 57 patients~     (strict glucose control group) we aimed to maintain the blood glucose level between 4.4 and~     6. 1 mmol/L, while in 60 patients (standard glucose control group) it was maintained between~     7.8 and 10.0 mmol/L, with the use of continues insulin infusion. Insulin dose adjustments~     were based on measurements of glucose in capillary blood sample.~      Key words: surgical patients; mechanical ventilation; pneumonia; blood glucose; insulin~     infusion; hospital stay~   "
237450|NCT00447174|"~     1. Develop a treatment for clinically significant parental bereavement. The proposed~          treatment development activities include:~             1. Development of a treatment manual, associated fidelity rating forms, and training~               aids,~             2. Pre-testing the treatment manual with bereaved parents, and revision in~               consultation with treatment development experts,~        2. Conduct a randomized, wait-list control, pilot study of the proposed treatment:~             1. Measure treatment-related change in (a) complicated grief symptoms, the primary~               outcome variable, which will be assessed using the Inventory of Complicated Grief,~               and, (b) marital adjustment, the secondary outcome measure, to be assessed using~               the Dyadic Adjustment Scale. These outcomes will be assessed in treatment and~               control groups at baseline, at treatment conclusion, and at three month follow-up.~             2. Test the difference between the treatment and control groups on changes from~               baseline to three month follow-up on the exploratory outcome variables of PTSD,~               depression, social and work impairment, and quality of life~             3. Estimate effect sizes of these differences in changes in outcomes~        3. Develop a proposal for a randomized controlled trial of the treatment, based on the~          results of aim 2.~   "
237451|NCT00447161|"~     To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic~     associated diarrhea among hospitalized immunocompetent Filipino children.~   "
237452|NCT00447148|"~     Aim of this study is to evaluate whether the length of coronary segments, assessed by an~     experienced operator, using the optimal view of standard 2-dimensional coronary~     angiography, is over/underestimated with respect to the one evaluated automatically with the~     help of a 3-dimensional coronary reconstruction model. Moreover, both techniques are compared~     with an in-vivo surrogate of the real length of the coronary segment under evaluation, i.e.~     an intra-coronary marker guide-wire, which is a wire with markers placed at fixed and known~     distance along its length in its distal (intra-coronary) part. Two hypotheses are tested: (1)~     the length of a coronary segment evaluated with a standard 2-dimensional optimal view~     over/underestimates the length assessed by a 3-dimensional coronary model that automatically~     detects the least foreshortened length of the segment under evaluation, and (2) the~     3-dimensional model approximates more closely than standard 2-dimensional angiography, the~     real length of the segment detected by the marker guide-wire.~   "
237453|NCT00447135|"~     The purpose of this research is to learn more about the function of the body's ability to~     fight infection when the immune response is activated when injury occurs, in the elderly~     population.~   "
237454|NCT00447122|"~     Phase II study of lapatinib and gemcitabine for patients with metastatic pancreatic cancer.~   "
237455|NCT00447109|"~     The purpose of this study was to compare the incidence of ventilator-associated pneumonia~     between two groups of patients randomised to have closed system suction catheter changes~     every 24 hours and patients having closed system suction catheter changes every seven days or~     as required.~   "
237456|NCT00447096|"~     This research study evaluates an experimental device for the treatment of the depressed phase~     of Bipolar Disorder Type II. Repetitive Transcranial Magnetic Stimulation (rTMS) is an~     experimental procedure where a device delivers an alternating magnetic field to a focal area~     of the brain. When the coil is placed against the scalp on the left frontal area of the head,~     the magnetic field is focused to a region of the brain that is thought to be involved in~     depression. This study is intended to test if rTMS can affect this region of the brain in a~     way that improves the symptoms of depression related to Bipolar Disorder Type II. The purpose~     of this study is to obtain safety and efficacy information regarding the use of~     rTMS(Repetitive Transcranial Magnetic Stimulation) for patients in the depressed phase of~     Bipolar Disorder Type II.~   "
237457|NCT00447083|"~     -  To establish whether ultraviolet light exposure acutely reduces perceptions of pain in~          patients with fibromyalgia.~        -  To establish whether a series of UV light exposures has a cumulative effect on~          fibromyalgia pain.~   "
237458|NCT00447070|"~     It is known that certain antiviral therapies, the socalled protease inhibitors, used in the~     treatment of HIV infection has an untowarded effect on the blood vessels, promoting early~     occurence of atherosclerosis. A a newer protease inhibitor, atazanavir, has been shown to~     have no negative effect on the levels of blood cholesterol and it is hypothesized that this~     may indicate that atazanavir is less prone to induce atherosclerosis. An early sign of~     atherosclerosis is a reduced vasomotion and this study investigate the influence of~     atazanavir on functionality of the conduit blood vessels compared to that of standard~     antiviral therapy.~   "
237459|NCT00447057|"~     This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect~     of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line~     setting (such as progression-free survival [PFS], disease control rate, best response rate,~     time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared~     to pemetrexed plus erlotinib combination.~   "
237460|NCT00447044|"~     The purpose of this study is to see if a combination of resistance exercises and amino acid~     capsules can reduce muscle loss and maintain muscle function during bedrest. This experiment~     will imitate many of the physical conditions experienced by astronauts during space flight by~     examining the effects of resistance exercise or nutrition on muscle during 2 days of bedrest.~     The diet of astronauts will also be imitated by providing diets in the General Clinic~     Research Center.~   "
237474|NCT00446862|"~     The primary hypothesis is that titration of ACE inhibitor and Angiotensin Receptor Blockers~     (ARBs)to reduce urine protein excretion to < 500 mg per day in Fabry Patients receiving~     agalsidase beta therapy at 1 mg/kg every two weeks will slow the progression rate of decline~     of glomerular filtration rate (GFR) compared to case controls drawn from the~     Genzyme-sponsored Phase III extension study (GFR 60 to 125 ml/min/1.73 m², urine protein > 1~     gram/day) or the Phase IV study (GFR 20 to 60 ml/min/1.73 m², urine protein > 0.5 gram/day).~     After a 3 month initial Evaluation Phase, the patients will be followed during a 24 month~     Observation Phase. FAACET is an open label, prospective observational study. The primary~     objective is reduction of first morning urine protein/creatinine ratio to < 0.5 gram/gram.~     The primary outcome measure is the regression slope of MDRD GFR with time in years~   "
237475|NCT00446849|"~     To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX~     mesalamine once daily.~   "
237461|NCT00447031|"~     Exudative age related macular degeneration (ARMD) is most common cause of blindness in old~     population. It is clear that no single therapy addresses the multifactorial pathogenesis of~     the disease. Recently, studies of intravitreal anti-VEGF therapies such as pegaptanib and~     bevacizumab have shown the beneficial effect in visual acuity in the treatment of neovascular~     ARMD. However, the problem with these intravitreal injections is that therapy must be~     frequently administered for a prolonged but unknown period of time to maintain the benefit.~     Prolonged, frequent injections may be associated with additional safety risk,lack of~     convenience and high treatment cost.~      Intravitreal steroid injection with anti-inflammatory properties limits any further VEGF~     upregulation initiated by the inflammation which has been known as one of the pathogenesis~     and causes of recurrence after the treatment of the neovascular ARMD.~      The researchers hypothesize that the combined treatment of intravitreal bevacizumab and~     triamcinolone acetonide may decrease the recurrence rate after the treatment and obviate the~     frequent intravitreal injections in the treatment of neovascular ARMD.~      In this study, the researchers will compare the recurrence rate of combined treatment of~     intravitreal bevacizumab and triamcinolone acetonide versus intravitreal bevacizumab alone in~     the treatment of neovascular ARMD.~   "
237462|NCT00447018|"~     The purpose of this study is to determine whether mannitol is as effective as hypertonic~     saline solution in the treatment of elevated intracranial pressure in patients with brain~     injury.~   "
237463|NCT00447005|"~     To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by~     reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.~   "
237464|NCT00446992|"~     The purpose of this study was to describe metabolic changes in the first 16 weeks of~     anti-psychotic treatment in previously drug-naïve patients with psychosis.~      We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment~     predicts a disproportionately greater increase in insulin resistance with olanzapine~     treatment.~   "
237465|NCT00446979|"~     This study will help determine whether UC-781 gel is safe when applied to the vagina twice~     daily for 14 days, and will assess whether women and men find the gel acceptable to use.~   "
237466|NCT00446966|"~     The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids~     reduce atrial fibrillation and other outcomes after cardiac surgery. In this~     placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery~     with or without valve repair will be treated with omega-3 polyunsaturated fatty acids~     perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty~     acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3~     polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery,~     decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids~     decrease intensive care unit and hospital length-of-stay.~   "
237467|NCT00446953|"~     Comparison of two randomized group :~        -  caesarean section planned at 38 weeks after 2 antenatal injections of 12 mg of~          betamethasone 48 h before.~        -  caesarean section planned at 39 weeks without corticosteroid.~      The aim is to demonstrate that programming caesarean section at 38 weeks of pregnancy, after~     antenatal corticosteroid, allows to avoid caesarean section in emergency (because of a labour~     before 39 weeks), without increasing the neonatal respiratory distress rate.~   "
237468|NCT00446940|"~     Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load~     changes and liver tests change.~   "
237469|NCT00446927|"~     The current method of evaluating the surgical repair during surgery is limited to~     echocardiography (a noninvasive diagnostic procedure that uses ultrasound to study the~     structure and motions of the heart) or an invasive procedure called cardiac catheterization.~      The SPY imaging system makes use of the fluorescence properties of indocyanine green (ICG) to~     obtain high quality images in blood vessels. ICG is a green dye used to test heart output.~     The use of the SPY imaging system during surgery may provide valuable information regarding~     successful vessel connection and the area remaining unblocked.~      This study will compare the results of images to echocardiography and conventional~     angiography results.~      With SPY imaging, congenital heart surgeons would be able to check the quality of the~     procedure and revise, redo or perform additional procedures as dictated by the images before~     the patient leaves the operating room.~   "
237470|NCT00446914|"~     This program developed by the HSFO aims at helping people of Ontario and their primary~     healthcare providers better diagnose, manage and control high blood pressure. The High Blood~     Pressure Strategy brings together healthcare providers and patients to improve the way in~     which family doctors, nurse practitioners and pharmacists work together and with patients~     towards improved control of high blood pressure through the use of evidence-informed tools~     combined with local systems change.~   "
237471|NCT00446901|"~     The aim of this study is to determine whether selenium supplementation leads to changes in~     selenium levels and gene expression profiles in prostate tissue.~   "
237472|NCT00446888|"~     The purpose of the study is to compare two different nutritional supplements with respect to~     their effect on building muscle, and to determine the factors that control the rate at which~     muscle tissue can be produced in subjects with cancer. After three days of receiving all~     meals from the Reynolds Institute on Aging in order to stabilize their diet, subjects will~     then return to the Institute to perform a single day study, where they will be given one of~     two supplements to drink. Blood will be taken from a catheter placed in one of their arms and~     three muscle biopsy samples will be taken from a leg. Subjects will have x-ray evidence of~     cancer and be 40 years of age or older in order to participate. It is the hypothesis that a~     nutritional supplement with a high amount of protein and containing leucine will target the~     metabolism problems in cancer patients.~   "
237473|NCT00446875|"~     The purpose of this study is to examine the analgesic properties of oral sucrose during~     routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will~     significantly decrease the objective measures of acute pain during routine immunizations.~   "
237476|NCT00446836|"~     The purpose of this study is to determine whether Xyotax, a conjugate of the taxane drug~     paclitaxel, is effective in the treatment of prostate cancer that is no longer responsive to~     hormone therapy.~   "
237831|NCT00442390|"~     Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects~     of physiological cortisol substitution and withdrawal is studied and related to the clinical~     syndrome of adrenal insufficiency.~   "
237477|NCT00446823|"~     This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for~     its ability to naturally (autolytically) remove nonviable tissue and create a healthy~     vascular wound bed. Results will compare venous ulcers treated with Xylos XCell cellulose~     dressing plus standard care to those treated with standard care alone. The hypothesis is that~     XCell will demonstrate more autolytic debridement than the standard of care.~   "
237478|NCT00446810|"~     An AGE-rich diet can induce after 2-6 weeks persistent increases in mediators linked to~     vascular dysfunction (e.g. TNFα, VCAM-1) in people with type 2 diabetes mellitus (T2DM).~     Benfotiamine (BT), the liposoluble derivative of vitamin B1, blocks several pathways common~     to hyperglycaemia- and AGE-induced endothelial dysfunction. We have shown that advanced~     glycation end products (AGE) of a regular mixed meal can acutely induce vascular dysfunction~     in T2DM and that this effects can be prevented by a three days pretreatment with BT.~      The hypotheses of this study are that chronical treatment with benfotiamine (900 mg/day for 6~     weeks) in people with type 2 diabetes mellitus:~        1. prevents postprandial impairment of endothelial function after a high-AGE meal.~        2. Improves fasting endothelial function.~        3. Improves parameters of autonomic function in fasting and postprandial state.~        4. Improves insulin sensitivity and prevents postprandial increase in insulin resistance.~   "
237479|NCT00446797|"~     To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day~     (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.~   "
237480|NCT00446784|"~     CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this~     study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in~     subjects with rheumatoid arthritis already receiving methotrexate~   "
237481|NCT00446771|"~     The study has an open-label, randomized, crossover design, in which each subject will receive~     mannitol powder for inhalation using a dry powder inhaler with and without premedication with~     a bronchodilator, mannitol powder for inhalation in capsules administered orally, and~     mannitol in a commercial formulation designed for intravenous use.~   "
237482|NCT00446758|"~     To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool~     children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and~     improves growth.~   "
237483|NCT00446745|"~     Numerous studies have demonstrated that excess perivisceral adipose tissue is associated with~     metabolic diseases such as insulin resistance.~      In skeletal muscle, insulin resistance has been correlated with reduced mitochondrial~     oxidative functions. According to the actual theory, mitochondrial dysfunctions are proposed~     to play a causal role in the aetiology of insulin resistance. Mechanisms involve increased~     intramyocellular lipids storage. Yet, the causes responsible for the decline in muscle~     mitochondrial functions remain to be elucidated.~      The investigators hypothesize that these alterations are induced by combined changes in~     plasma profiles of lipids and adipokines, which originate from perivisceral adipose tissue.~     The study aims at answering the following questions :~        -  Are muscle mitochondrial functions altered in association with increased perivisceral~          adipose tissue storage?~        -  Do changes in the pattern of plasma lipids and adipokines explain this correlation?~   "
237484|NCT00446732|"~     According to the Israeli Ministry of Health requirement, this study was designed to evaluate~     the efficacy of the UroShield system is patients that require urinary catheterization. This~     was designed to compare standard treatment (urinary catheter alone) with the UroShield~     treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort,~     Biofilm prevention and trauma.~   "
237485|NCT00446719|"~     The investigators hypothesize that Rellidep will be effective in improving the symptoms of~     major depression. The available evidence strongly suggests that Rellidep contains a mood~     altering ingredient or ingredients. This open-label, non-randomized study sets out to~     validate its potential antidepressant activity.The study will include secondary aims of~     evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom~     associated symptom of depression and improving quality of life.~      About twenty-five patients with major depressive disorder will be assigned to open-label~     Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various~     measures of global improvement, depression, quality of life, sexual experience, anxiety and~     measures of side effects as well as standard laboratory tests.~   "
237486|NCT00446706|"~     ARDS (Acute Respiratory Distress Syndrome) is a condition of severe inflammation and excess~     fluids in the lungs that impairs their function of oxygen uptake to the point of needing a~     ventilator (breathing machine) to help them obtain enough oxygen into the body. Because of~     the high amounts of gas that the ventilator has to give to these patients, high pressures may~     develop deep into the lungs and produce complications for the patient. However, physicians~     sometimes cannot recognize it because it requires special equipment to measure pressure deep~     in the lungs. The goal of this study is to determine if the amount of this pressure can be~     calculated using mathematical formulas and the routine numbers provided by ventilators. The~     study consists on making the conventional measurement of this deep pressure and at the same~     time calculate this same pressure from other measurements that the ventilator routinely~     provides, to see if the calculated value can replace the more complicated conventional~     measurement. The measurements will be done by:~        1. placing a small device along the tubing connecting the patient to the ventilator;~        2. giving medicines to relax the muscles (if the patient is not already receiving them);~          and~        3. making the ventilator hold the patient's breath for a few seconds to take measurements.~      This is repeated after the breathing rate of the ventilator is increased or decreased mildly.~     Risks related to the medicine to be used and the measuring maneuvers are rare but include~     transient narrowing of windpipes, transiently low heart rate, blood pressure or blood oxygen,~     and allergic reactions. This is not a treatment. The information obtained during the study~     will be shared with the treating doctors who may find it useful to make adjustments to the~     ventilator. The patient may receive no direct benefit from being in this study; however, the~     findings may contribute to better care for this kind of patients in the future.~   "
237487|NCT00446693|"~     The purpose of this study is to clinically assess the safety and performance of the EndoFast~     Reliant™ system as a less invasive treatment for Pelvic Organ Prolapse.~   "
237504|NCT00446472|"~     The objective of this study is to compare the effectiveness and safety of windowed casts with~     Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of~     diabetic ulcers on the legs and feet.~   "
237505|NCT00446459|"~     This is a 12-month, phase II, prospective, open label study, to evaluate the effect of~     mycophenolate mofetil (MMF) among patients on the kidney transplant list with high Panel of~     Reactive Antibody (PRA) levels.~      On average, increasing the PRA from 0 to 50% specifically in the Washington Organ Procurement~     Organization (OPO) increases the waiting time from 3 to 6 years. Spontaneous decreases in the~     PRA rarely occur and is associated with a decreased chance for transplantation and a~     decreased rate of survival.~   "
237488|NCT00446680|"~     The purpose of this study is to determine the efficacy and safety of chronic treatment with~     inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have~     demonstrated an improvement in lung function related to small airways obstruction and a~     significant improvement in respiratory symptoms and quality of life after a 2 week treatment~     with mannitol. This current study seeks to support these early findings and to extend the~     evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the~     hypothesis that enhanced mucus clearance will improve the lung function and clinical~     presentation in this population, will be investigated. We also hypothesize that enhanced~     mucociliary clearance will result in a sustained reduction in mucus load, thus providing less~     opportunity for bacteria to proliferate, affording a reduction in antibiotic use and~     hospitalizations. The initial 6 month blinded phase will be followed with an additional 6~     months of open label treatment.~   "
237489|NCT00446667|"~     COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions,~     and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids~     for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory~     failure. However, associated mucus hypersecretion is responsible for much of the inflammation~     and infection. The use of pharmaceutical agents to assist in the early clearance of the~     retained mucus has been limited, primarily because of lack of demonstrated effect. There has~     been a recent development of interest in pursuing new therapies for improving mucociliary~     clearance and several studies have demonstrated that clinical outcomes can be improved when~     osmotic agents such as mannitol are added to standard treatments. The purpose of this study~     is to conduct a pilot safety study in patients with an acute exacerbation of COPD to~     determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.~   "
237490|NCT00446654|"~     The purpose of this research study is to determine how safe and effective subconjunctival~     injections of CGC-11047 are in subjects with wet age related macular degeneration at two~     different dosing intervals.~   "
237491|NCT00446641|"~     This study will recruit 316 ischemic stroke patients taking aspirin.~      They will be randomly assigned into cilostazol group or placebo group. Every patients will~     take 200mg of cilostazol a day or placebo for 1 month.~      The primary outcome variable of this study is rate of biochemical aspirin resistance on the~     Ultra Rapid Platelet Function Assay-ASA.~   "
237492|NCT00446628|"~     The purpose of this study is to understand the spread of influenza (flu) in schools and~     households with elementary (K-5) school children, and develop ways to reduce the flu using~     non-pharmaceutical means.~   "
237493|NCT00446615|"~     In 2001, an estimated 1.9 million Canadians had chronic renal disease and the number of~     patients being treated for end stage renal disease climbed by nearly 20% in 5 years. Many~     medications commonly used in elderly patients are excreted by the kidney. Failure to adjust~     doses in those with impaired renal function can result in medication overdose, leading to~     potentially serious morbidity and mortality. Studies in hospitals and long term care~     facilities have found a 19-67% rate of non-compliance with guidelines for medication dose~     adjustment in patients with renal insufficiency and in ambulatory care one study found a 69%~     rate of non-compliance. Since primary care physicians write 80% of prescriptions for those~     aged 65 years, there is a need for interventions to improve prescribing to patients with~     renal impairment in primary care.~      This study will develop an audit tool and electronic decision support tool that will be~     incorporated into the electronic medical record in a large academic family health centre. It~     is seen as a preliminary step in a project to assess the effectiveness of a multifaceted~     intervention including chart audit, personalized feedback to prescribers, a~     pharmacist-facilitated group learning session and the use of an electronic decision support~     tool incorporated into the electronic medical record.~   "
237494|NCT00446602|"~     The purpose of this study is to evaluate the effectiveness of PROCRIT (Epoetin alfa) 80,000~     Units given once weekly or 80,000 Units given once every two weeks in anemic patients with~     Low- or Intermediate-1 risk Myelodysplastic Syndromes (MDS).~   "
237495|NCT00446589|"~     Hemodialysis patients with low bone density (total hip T-score <-2.5) will be assigned to~     receive teriparatide (those with histologic confirmation of adynamic bone disease) or~     ibandronate (subjects with increased osteoclast number on bone biopsy).~      Follow-up period: one year. A second bone biopsy at the end of the study.~   "
237496|NCT00446576|"~     The purpose of this study is to assess whether maintaining hemoglobin (Hb) levels at normal~     or sub-normal levels with Epoetin Alfa can influence the health status, left ventricular mass~     and quality of life of early renal insufficiency subjects without additional safety concerns.~   "
237497|NCT00446563|"~     This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients~     with hypertension and left ventricular hypertrophy~   "
237498|NCT00446550|"~     This study is being conducted to evaluate the safety and effects of AT2101 in patients with~     type I Gaucher disease who are not receiving ERT or SRT.~   "
237499|NCT00446537|"~     Skill acquisition refers to the process of improvement of performance following practice~     experience. This process is the basis for generation of a long-lasting memory. Individuals~     with Attention Deficit Hyperactivity Disorder (ADHD) have been shown to be impaired on some~     performance aspects of previously learned skills, an impairment that is often ameliorated, at~     least temporarily, by psychostimulant medication (the standard therapy in ADHD). The proposed~     study aims to define the course of learning and of generation of long-term memory~     consolidation in individuals with ADHD, and to essay the effectiveness of psychostimulant~     medication on both the learning and retention of the skills.~   "
237500|NCT00446524|"~     The purpose of this study is to evaluate long-term safety and tolerability of once daily~     administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in~     patients with essential hypertension.~   "
237501|NCT00446511|"~     The purpose of this extension study is to compare the long-term safety of valsartan versus~     enalapril, and the effectiveness of the combination of valsartan and enalapril versus~     enalapril alone in children with hypertension.~   "
237502|NCT00446498|"~     To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema~     treated with CPAP or NPPV.~   "
237503|NCT00446485|"~     The purpose of the study is to determine weather Ginkgo biloba standardized extract (24%~     ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and~     concentration impairment~   "
237508|NCT00446420|"~     Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective~     outpatient colonoscopy increases cognitive impairment at hospital discharge without improving~     intraoperative conditions or reducing intraoperative side-effects.~      200 healthy patients aged 18 years or older will be randomised to receive propofol or~     propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital~     discharge using Cogstate computerised testing software.~   "
237509|NCT00446407|"~     Depressive and anxiety disorders (termed as 'Common Mental Disorders') affect as many as one~     in four persons attending primary care; most patients do not receive effective treatments.~     Although the integration of mental health in primary care is accepted as the only feasible~     way of managing Common Mental Disorders in developing countries, there is no evidence~     demonstrating how this can be done in a manner which is effective and affordable. The~     hypothesis of this trial is that a Collaborative Stepped Care package will be both clinically~     and cost-effective for the treatment of Common Mental Disorders in primary care.~   "
237510|NCT00446394|"~     The purpose of this project is to evaluate an exercise and health promotion program for older~     adults with mild memory loss. The study will investigate the efficacy of a memory-enhanced~     exercise and health promotion program to determine whether it is more effective than a social~     walking program in delaying further memory decline, improving mood and physical function, and~     enhancing quality of life.~   "
237511|NCT00446381|"~     Patients with proliferative diabetic retinopathy or clinically significant diabetic macular~     edema requiring surgical intervention will receive a pre-operative injection of Macugen. An~     initial, pre-injection vitreous tap will be done in order to provide baseline VRGF 165 and~     cytokine levels. At the onset of the vitrectomy, a second vitreous sample will be taken to~     obtain intra-operative levels of Macugen, VEGF 165 and cytokines.~   "
237512|NCT00446368|"~     Patients with metastatic renal cell cancer will be enrolled to receive RAD001 to determine~     whether the use of RAD001 will result in an improvement in the time to tumor progression.~   "
237513|NCT00446355|"~     The purpose of the study is to establish the clinical disease outcomes and features of CDAD~     associated with variant tcdC genotypes. Two hypotheses are to be tested in this study:~        1. Severe CDAD and tcdC truncation:~           Severe CDAD (defined by death and/or colectomy or secondary endpoints) is associated~          with severe truncations (> 6 amino acid residues) in TcdC, a negative regulator of toxin~          A/B production.~        2. Disease in low risk populations (patients never exposed to health care facilities and/or~          patients who never received antibiotics) of any severity is attributable to strains of~          C. difficile with severe tcdC truncation.~   "
237514|NCT00446342|"~     The purpose of this study is to assess the safety and tolerability of escalating doses of~     SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2~     dose.~   "
237515|NCT00446329|"~     The 1st phase of the study will assess the acute biochemical response of PTH, calcium and~     phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per~     day.~      The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD~     (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to~     control secondary hyperparathyroidism without simultaneous administration of other vitamin D~     compounds.~   "
237516|NCT00446316|"~     This is a research study that will investigate the effects of antacids (often used to treat~     stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of cancer) in~     healthy volunteers. Twelve healthy volunteers (six men and six women) will be recruited to~     complete the study. This research study will compare Gleevec® in the body when taken with and~     without antacids. Each volunteer will receive a 400 mg pill of Gleevec® on two occasions. One~     one occasion they will take the dose of Gleevec® alone. On another occasion, they will take~     the Gleevec® 15 minutes after taking a 20 mL dose of antacids. Several blood samples will be~     drawn to measure the concentrations of Gleevec® and its breakdown products in the blood, with~     and without the influence of antacids.~   "
237517|NCT00446303|"~     A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving~     complete or partial remission (CR or PR) after intensive chemoterapy.~      The primary objective is response duration (MDS or AML)~   "
237518|NCT00446290|"~     Considering synergism between docetaxel (D), capecitabine (X), and oxaliplatin (O) and~     favourable toxicity profile of oxaliplatin over cisplatin, it is to be expected that~     combination of docetaxel, capecitabine, and oxaliplatin (DXO) will be more effective than~     other regimens and feasible in advanced gastric cancer. DXO regimen can be also easily~     administered on out-patient setting. However, so far, DXO combination has not been tried in~     advanced gastric cancer. The investigators will determine maximum tolerated dose of DXO~     regimen in this phase I study.~   "
237519|NCT00446277|"~     The aim of the present study is to evaluate changes in the morphology and function of the~     corneal endothelium before and after cataract surgery in patients with diabetes type II. Also~     to explain if determination of HgbA1c in diabetics is a predictor for the changes in~     morphology and function.~   "
237520|NCT00446264|"~     The restoration of endogenous insulin secretion carries significant hopes for shifting the~     paradigm of life long exogenous insulin therapy in selected groups of patients with type 1~     diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in~     2000 new standards for islet transplantation in patients with brittle T1D by achieving~     insulin independence in 80 percent of patients. These seminal results have however proved~     much more difficult to duplicate than initially expected.~      This single center phase 2 clinical trial, duplicating the Edmonton protocol, is designed for~     confirming the consistent short term efficacy and safety of sequential islet~     allotransplantation with steroid free immunosuppression in patients with severe T1D.~   "
237521|NCT00446251|"~     This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab~     with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just~     completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment~     and at 6 and 12 months on combined therapy as well as the rates of transplant will be~     compared and evaluated using descriptive analysis.~   "
237579|NCT00445445|"~     RATIONALE: Studying mammograms for breast density changes over time may help doctors predict~     breast cancer risk.~      PURPOSE: This natural history study is looking at changes in breast density and gathering~     health information over time to assess breast cancer risk in women with breast cancer and in~     healthy women.~   "
237522|NCT00446238|"~     The purpose of this study is a randomized trial of cognitive-behavioral intervention (CBI)~     for eligible adolescents who have Inflammatory Bowel Disease and subsyndromal depressive~     symptoms, but who did not meet diagnostic criteria for major depressive disorder at the time~     of randomization into the study.~      Hypotheses~        1. This preliminary randomized trial will demonstrate the feasibility of a large-scale~          research initiative.~        2. Subjects will experience no adverse events, and the CBI group will demonstrate improved~          negative cognitions, depressive symptomatology, and functioning at the post-intervention~          and 6- through 12-month follow-ups.~   "
237523|NCT00446225|"~     A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus~     chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK)~     domain of the EGFR.~   "
237524|NCT00446212|"~     We hypothesise that patients who receive propofol for maintenance of anaesthesia will report~     dreaming more often when they emerge from anaesthesia than patients who receive desflurane~     for maintenance of anaesthesia.~   "
237525|NCT00446199|"~     The purpose of this study is to determine the lowest effective dose of the study drug for the~     relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.~   "
237526|NCT00446186|"~     The clinical study evaluates the efficacy and safety of MK0476 in adult patients with~     allergic rhinitis.~   "
237527|NCT00446173|"~     Primary Objective:~      1. To study ex-vivo purging of autologous hematopoietic stem cells that will be used to~     support high-dose chemotherapy in patients with chronic myelogenous leukemia (CML). Major~     endpoints are neutrophil engraftment and survival.~      Secondary Objectives:~        1. To evaluate the toxicity of ex-vivo purged autologous cells when used to support~          high-dose chemotherapy.~        2. To evaluate the rate and duration of cytogenetic remissions achieved with this strategy.~        3. To determine the time to platelet recovery to 20,000/mm3.~        4. To determine the one-year survival rate.~   "
237528|NCT00446160|"~     It is now estimated that the number of adults with congenital heart disease in the U.S is~     over 800,000. Unfortunately, these patients, in some way, have become a lost population. They~     have congenital abnormalities familiar to a children's hospital, yet have surpassed the age~     cutoff for admission.~      Recently, we have developed a specialized program to care for this unique patient population.~     Dedicated programs such as ours hope to optimize patient care, consolidate specialized~     resources, provide sufficient patient numbers for training and maintain expertise and~     facilitate research in this unique population.~   "
237529|NCT00446147|"~     Although pyridoxine has been used empirically for the prevention of capecitabine associated~     hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled~     trials. The investigators therefore performed a prospective randomized double-blind study to~     determine whether pyridoxine 200 mg/day can prevent the development of HFS when given~     concurrently with capecitabine. The investigators also tested the ability of pyridoxine to~     treat primary occurrence of grade 2-3 HFS.~   "
237530|NCT00446134|"~     The objective of the study is to select an optimal dose of taribavirin by comparing the~     efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin~     800 to 1400 mg/day based on body weight, both administered in combination with peginterferon~     alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.~   "
237531|NCT00446121|"~     The main purpose of the study is to evaluate the effect of mannitol on the cilia's beat~     frequency (ciliary beat frequency) in COPD patients.~   "
237532|NCT00446108|"~     This is a retrospective chart review examining children and adults with history of Tetralogy~     of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement.~     The primary interest of the study is to analyze the routine pre- and post-operative imaging~     studies.~   "
237533|NCT00446095|"~     Patients: B-cell lymphoma, refractory, diffuse, nodular, mantle, other Phase I : Two groups~     of 6 patients, escalating dose tolerability- 28 days Phase II: Three groups of 16 patients~     (nodular, diffuse large cell, mantle cell plus others). Oral bid dosing with highest~     tolerable dose until toxicity, progression, or withdrawal~   "
237534|NCT00446082|"~     This study will assess the pharmacokinetic profile and the safety/tolerability profile of~     single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with~     acromegaly and patients with carcinoid disease~   "
237535|NCT00446069|"~     The purpose of the study is to determine the effect of Egalet® Morphine once daily compared~     to MST Continus twice daily on pain intensity and use of rescue medication for break through~     pain after 2 weeks of treatment in patients with pain due to cancer.~   "
237536|NCT00446056|"~     The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen,~     used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over~     first 2 weeks in patients with pediatric bronchial asthma aged 6 to < 15.~      The effect of body weight on the efficacy and safety of montelukast will also be evaluated in~     this study.~   "
237537|NCT00446043|"~     This is a multi-centre, open-label, non-comparative study to evaluate the long-term safety~     and efficacy profile of Adapalene/Benzoyl Peroxide Gel.~      Subjects are evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.~      Safety is evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability~     Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing~     (haematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations.~     Efficacy is evaluated by analysis of Percent Change from Baseline in Inflammatory,~     Noninflammatory, and Total Lesion Counts, and by the Subject’s Assessment of Acne.~   "
237538|NCT00446030|"~     This is a phase II, open-label, multicenter, pilot study of the safety and efficacy of two~     Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with~     node positive or high risk node negative breast cancer.~      The primary objective of this study was to evaluate the cardiac safety, and the secondary~     objectives were to evaluate safety and toxicity of participants treated with bevacizumab ±~     trastuzumab administered with 2 different docetaxel-based combination regimens.~      This study was originally designed to also evaluate disease-free survival (DFS) and overall~     survival (OS); however, based on a protocol amendment, follow-up was shortened from 10 years~     to 2 years, and the efficacy endpoints of disease free survival and overall survival were~     deleted from the protocol.~   "
237539|NCT00446017|"~     Myocardial dysfunction necessitating inotropic support is a typical complication after~     on-pump cardiac surgery. This prospective, randomized pilot-study analyses the metabolic and~     renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support~     after coronary-artery-bypass-grafting. With respect to data derived from patients with sepsis~     shock and results from studies using phosphodiesterase-inhibitors prophylactically, the~     hypothesis is tested that adrenaline may be associated with unwarranted metabolic effects~     (hyperlactatemia and hyperglycemia) and renal dysfunction.~   "
237540|NCT00446004|"~     This is a research study that will investigate the effects of proton pump inhibitors (often~     used to treat stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of~     cancer) in healthy volunteers. Twelve healthy volunteers (six men and six women) will be~     recruited to complete the study. This research study will compare Gleevec® in the body when~     taken with and without proton pump inhibitors (PPI). Each volunteer will receive a 400 mg~     pill of Gleevec® on two occasions. On one occasion they will take the dose of Gleevec® alone~     (without PPI). On another occasion, they will take the Gleevec® after taking 40 mg of PPI~     daily by mouth for six days. Several blood samples will be drawn to measure the~     concentrations of Gleevec® and its breakdown products in the blood, with and without the~     influence of PPI.~   "
237541|NCT00445978|"~     This Phase 2a, multicenter, open-label, dose-escalation study is designed to assess the~     safety and biologic activity of daily oral administration of 4 escalating doses of 6R-BH4~     over 16 weeks in subjects with sickle cell disease. During an optional extension phase, the~     study will assess the safety, tolerability, and efficacy of extended treatment with 6R-BH4,~     for a total of up to 2 years.~   "
237542|NCT00445965|"~     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8,~     can find tumor cells and carry tumor-killing substances to them without harming normal cells.~     This may be an effective treatment for central nervous system cancer or leptomeningeal~     metastases.~      PURPOSE: This phase II trial is studying the side effects and how well iodine I 131~     monoclonal antibody 3F8 works in treating patients with central nervous system cancer or~     leptomeningeal cancer.~   "
237543|NCT00445952|"~     RATIONALE: Gathering information about how often fungal infections of the blood occur in~     patients with cancer or in patients who have undergone stem cell transplant may help doctors~     learn more about the disease.~      PURPOSE: This natural history study is collecting information about fungal infections of the~     blood over time from patients with cancer or from patients who have undergone a stem cell~     transplant.~   "
237544|NCT00445939|"~     The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the~     induction of clinical remission in Japanese subjects with Crohn's disease.~   "
237545|NCT00445926|"~     The study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS~     H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia~     patients~   "
237546|NCT00445913|"~     The proposed studies describe a randomized trial to evaluate the safety of a new~     diabetes-suppressive cell vaccine, consisting of autologous monocyte-derived dendritic cells~     treated ex vivo with antisense phosphorothioate-modified oligonucleotides targeting the~     primary transcripts of the CD40, CD80 and CD86 co-stimulatory molecules (immunoregulatory DC;~     iDC). The hypothesis to be tested in this study is that iDC are safe and without toxicity in~     established type 1 diabetic patients.~      Fifteen (15) individuals exhibiting fully-established, insulin-dependent type 1 diabetics,~     without any diabetes-related complications, infectious disease, or other medical anomaly,~     will be enrolled to establish safety of the approach. 7/15 volunteers will be administered~     autologous control dendritic cells and 8/15 will be administered iDC. The study is~     anticipated to be complete by twelve (12) months.~      Currently, other than a humanized anti-CD3 antibody with considerable side effects, there is~     no other means to reverse new-onset type 1 diabetes. These studies will be the first ever to~     employ autologous dendritic cell transfer to suppress an autoimmune disease and to perhaps~     reverse it early on in the clinical process.~   "
237547|NCT00445900|"~     RATIONALE: Giving thalidomide together with prednisone and cyclophosphamide may lessen~     symptoms caused by myelofibrosis and myeloid metaplasia.~      PURPOSE: This phase II trial is studying the side effects and how well giving thalidomide~     together with prednisone and cyclophosphamide works in treating patients with myelofibrosis~     and myeloid metaplasia.~   "
237548|NCT00445887|"~     This randomized phase II trial is studying how well levonorgestrel works in preventing~     ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of~     certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian~     cancer.~   "
237549|NCT00445874|"~     The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with~     a contact lens compared to placebo in preventing ocular itching associated with allergic~     conjunctivitis~   "
237550|NCT00445861|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving cetuximab, docetaxel, and cisplatin together with~     radiation therapy before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed.~      PURPOSE: This phase I/II trial is studying the side effects of cetuximab, docetaxel,~     cisplatin, and radiation therapy and to see how well they work in treating patients with~     locally advanced esophageal cancer that can be removed by surgery.~   "
237551|NCT00445848|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop~     the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving~     erlotinib together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab~     works in treating patients with stage IIIB or stage IV primary non-small cell lung cancer who~     have never smoked.~   "
237552|NCT00445835|"~     Coronary artery disease is the first cause of death related to atherothrombosis.~   "
237553|NCT00445822|"~     Newly diagnosed pediatric patients (age < 19 years) with bcr-abl-positive CML will be treated~     with imatinib. Serial monitoring of treatment response is performed in one month intervals~     during the first three months of treatment and in three months intervals thereafter. Patients~     with non-response, poor response (either molecular, cytogenetic, or hematologic non-/poor~     response) or progress of the disease while under imatinib treatment will stop imatinib and~     undergo stem cell transplantation. All responders to imatinib treatment with an HLA matched~     donor will undergo stem cell transplantation not later than 2 years after diagnosis.~   "
237554|NCT00445809|"~     Some patients who undergo cardiovascular surgery requiring cardiopulmonary bypass will~     develop a kidney injury following their surgery. The purpose of this study is to take a blood~     sample from patients before they have this type of surgery and then at nine time points after~     their surgery to test their plasma for a biomarker called NGAL and compare the NGAL levels to~     their creatinine levels. We hypothesize that NGAL is an earlier marker for kidney injury than~     creatinine.~   "
237555|NCT00445796|"~     Primary Objective:~      To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day~     14, of administration of Arsucam® as a single daily intake versus two daily intakes.~      Secondary Objective:~      To compare the clinical safety of the two treatment regimens.~   "
237556|NCT00445783|"~     RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may~     help doctors understand the risk factors for melanoma relapse.~      PURPOSE: This clinical trial is studying the risk factors for melanoma in families with~     melanoma.~   "
237557|NCT00445770|"~     The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared~     with methotrexate (up to 8 mg per week) on the slowing of joint destruction.~   "
237558|NCT00445757|"~     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor~     and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery~     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic~     radiation therapy in treating patients with kidney tumors.~   "
237559|NCT00445744|"~     This trial is studying the side effects and how well giving cyclophosphamide and busulfan~     followed by donor stem cell transplant works in treating patients with myelofibrosis, acute~     myeloid leukemia, or myelodysplastic syndrome. Giving chemotherapy, such as cyclophosphamide~     and busulfan, before a donor stem cell transplant helps stops the growth of cancer cells. It~     also helps stop the patient's immune system from rejecting the donor's stem cells. The~     donated stem cells may replace the patient's immune cells and help destroy any remaining~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving tacrolimus and~     methotrexate after the transplant may stop this from happening~   "
237560|NCT00445731|"~     RATIONALE: A walking program may improve the ability to carry out daily activities after~     donor bone marrow transplant.~      PURPOSE: This randomized clinical trial is studying a structured walking program to see how~     well it works compared with standard therapy in cancer patients undergoing a donor bone~     marrow transplant.~   "
237561|NCT00445718|"~     This natural history study is collecting health information about infants with adrenal masses~     found on prenatal and/or neonatal imaging. Gathering information over time from imaging and~     laboratory tests of infants with adrenal masses may help doctors learn more about the disease~     and plan the best treatment.~   "
237562|NCT00445705|"~     This study will explore the safety and effectiveness of different doses of AGN 203818 in~     treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2~     parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over~     4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg~     BID AGN 203818 or placebo over 12 week treatment duration.~   "
237563|NCT00445692|"~     This phase II trial studies lenalidomide, dexamethasone, and clarithromycin in treating~     patients who have undergone stem cell transplant for multiple myeloma. Biological therapies,~     such as lenalidomide and clarithromycin, may stimulate the immune system in different ways~     and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving lenalidomide together with dexamethasone and~     clarithromycin may be an effective treatment for multiple myeloma.~   "
237564|NCT00445679|"~     This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate~     sustained release (DVS SR) in subjects with major depressive disorder.~   "
237565|NCT00445653|"~     RATIONALE: A study that evaluates DNA changes and other disease-related health information in~     patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding may~     help doctors learn more about the risk factors for Barrett's esophagus.~      PURPOSE: This clinical trial is looking at DNA changes and other disease-related health~     information as risk factors for Barrett's esophagus in patients with Barrett's esophagus,~     gastroesophageal reflux, or gastrointestinal bleeding.~   "
237566|NCT00445627|"~     This study will determine whether resting beta cells (cells in the pancreas that produce~     insulin) for 2 weeks will improve the ability of patients with Type 2 diabetes mellitus~     (T2DM) to make insulin. Beta cells can rest by giving patients insulin shots. The study will~     also examine how teenagers with T2DM feel about having diabetes and explore differences~     between young people with and without T2DM.~      This study includes patients 12 to 25 years of age with T2DM who are overweight and who were~     diagnosed within 2 years of enrolling in the study. Healthy individuals of normal weight or~     who are overweight are also eligible. Candidates are screened with a medical history,~     physical examination and laboratory tests.~      Participants with T2DM are assigned to one of two groups. Group 1 takes an anti-diabetes~     medicine called metformin and follows a diet prescribed by a study staff dietitian for 2~     weeks. Group 2 takes metformin, follows the prescribed diet, and receives insulin through a~     pump under the skin for 2 weeks. During these two weeks, all participants have the following~     tests:~        -  Frequent blood sugar checks.~        -  Oral glucose tolerance test (routine diabetes test in which blood samples are drawn~          before and several times after the subject drinks a sugary solution).~        -  Arginine stimulation to test the response of the body to arginine, a normal ingredient~          of food that stimulates the release of insulin. Two catheters are placed into veins in~          the arms, one to administer a liquid containing arginine, the other to draw the blood~          samples.~        -  Ultrasound of the blood vessels in the neck to check for hardening of the arteries.~        -  Metabolism test to measure the amount of oxygen used during rest. The subject breathes~          normally during rest while wearing a canopy over his or her head for about 20 minutes.~        -  MRI scans of the abdomen to examine the amount of fat in the belly (at the beginning and~          end of the study)~        -  DEXA scan to determine percent body fat.~        -  Tests to explore quality of life and feelings about health, work or school, friends and~          family.~        -  Exercise testing on a treadmill or stationary bicycle.~        -  Genetic studies for information on diabetes and obesity.~      Normal volunteers have blood draws, oral glucose tolerance testing, MRI scan, DEXA scan,~     psychological testing, exercise testing, and genetic testing.~   "
237567|NCT00445614|"~     Fish from the aquaculture sector constitutes an increasing part of the fish consumption in~     Denmark. The most important farmed fish in Denmark is the rainbow trout. Due to limited~     access of wild fish for the feed production, alternative feeding regimes of vegetable origin~     such as vegetable proteins and rapeseed oil are used instead of marine feed. This change in~     feeding regime may affect flesh quality and health and nutritional properties as the content~     of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) will presumably decrease in the~     meat. The objective of the study is to investigate the effect of vegetable based feed versus~     marine feed of farmed trout and its effect in healthy men on cardiovascular risk markers~     associated with the development of cardiovascular disease (CVD).~   "
237568|NCT00445601|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is~     not yet known whether giving gemcitabine directly into the bladder is more effective than a~     placebo in treating bladder cancer.~      PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works~     when given directly into the bladder compared with a placebo after surgery in treating~     patients with newly diagnosed or recurrent bladder cancer.~   "
237569|NCT00445588|"~     This phase II trial is studying how well giving erlotinib together with sorafenib works in~     treating patients with progressive or recurrent glioblastoma multiforme. Erlotinib and~     sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. Giving erlotinib together with sorafenib may~     kill more tumor cells.~   "
237570|NCT00445575|"~     This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to~     decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.~   "
237571|NCT00445562|"~     RATIONALE: Collecting blood samples and health information from patients with invasive breast~     cancer and from their brothers and sisters over time may help the study of cancer in the~     future.~      PURPOSE: This study is collecting blood samples and health information over time from~     patients with invasive breast cancer and from their brothers and sisters.~   "
237572|NCT00445549|"~     Background:~        -  Vandetanib is a drug that attacks a group of proteins on the surface of many cells,~          especially blood vessel cells and tumor cells.~        -  Tumors require the development of new blood vessels in order to grow and spread.~        -  In laboratory experiments, vandetanib slowed the growth of certain tumors and regulated~          their blood vessel growth.~        -  In early clinical trials, some patients' tumors did not grow for a period of time while~          they were receiving vandetanib.~      Objectives:~        -  To determine whether vandetanib can cause tumors to shrink or stabilize in some patients~          with ovarian cancer, fallopian tube cancer or primary peritoneal cancer.~        -  To determine, by tumor biopsy, if features of the tumor change with vandetanib treatment~          may predict if the tumor will likely respond to vandetanib.~      Eligibility:~        -  Women 18 years of age and older with ovarian, fallopian tube or primary peritoneal~          cancer that does not respond to standard treatment.~      Design:~        -  Patients take vandetanib daily, by mouth in 28-day cycles until their disease worsens or~          they develop unacceptable side effects.~        -  Tumor biopsies (surgical removal of a sample of tumor tissue) are done before starting~          vandetanib treatment and after 6 weeks of treatment.~        -  Patients are followed in the clinic every 4 weeks during treatment for a physical~          examination, blood tests, and review of laboratory studies and side effects.~        -  Patients have a computed tomography (CT) scan every 8 weeks to monitor tumor growth and~          magnetic resonance imaging (MRI) before starting vandetanib treatment, on the third day~          after taking vandetanib and 6 weeks into treatment.~        -  Patients quality of life is assessed with regularly scheduled questionnaires.~   "
237573|NCT00445523|"~     Patients with metastatic renal cell cancer will be enrolled to receive either Trovax® alone~     or Trovax® plus Interferon Alfa. The study will try to determine whether the use of Trovax®~     will delay tumor progression.~   "
237574|NCT00445510|"~     This will be a single centre, randomised, double-blind, placebo-controlled, 2-period~     crossover study to investigate the effect of treatment with repeat inhaled doses of GSK256066~     on bronchial hyper-reactivity to adenosine monophosphate.~   "
237575|NCT00445497|"~     RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the~     hospital. It is not yet known whether early hospital discharge is as effective as standard~     inpatient care in cancer patients receiving antibiotics for febrile neutropenia.~      PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing~     it with standard inpatient care in cancer patients receiving antibiotics for febrile~     neutropenia.~   "
237576|NCT00445484|"~     RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Vaccines may help the body build an~     effective immune response to kill cancer cells. Giving lenalidomide together with vaccine~     therapy may make a stronger immune response and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine~     therapy works in treating patients with relapsed or refractory multiple myeloma.~   "
237577|NCT00445471|"~     The current study aims at comparing outcomes achieved using the Mifne approach of treating~     autistic children with results obtained when routine standard treatment is used. A~     prospective comparative study will be performed comparing the results of 12 children treated~     at Mifne with 12 children treated with treatment as usual. A child and adolescent~     psychiatrist using the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic~     Observation Schedule-Generic (ADOS-G) will make the diagnostic assessment and a developmental~     psychologist will make the developmental and psychological assessments using the Vineland~     Adaptive Behavior Scales-Revised and the Bayley Scales of Infant Development (BSID II) before~     the child enters the study. Each child will be reassessed following completion of the Mifne~     intervention, at three and at six months after commencement of treatment. The control child~     will also be reassessed at three and at six months after commencement of a therapeutic~     intervention.~   "
237578|NCT00445458|"~     The purpose of this study is to learn whether it is safe and effective to administer HKI-272~     (neratinib) in combination with paclitaxel in patients with breast cancer.~   "
237580|NCT00445432|"~     To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical~     remission in Japanese subjects with Crohn's disease.~   "
237581|NCT00445419|"~     Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic~     hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER~     platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular~     immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a~     hepatitis C virus infection. In-depth research in recent years has shown that the cellular~     immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV~     vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together~     with a supportive helper T cell response (PeviPRO). This virosome-based technological~     combination in a single product represents a new generation of modular therapeutic vaccines.~   "
237582|NCT00445406|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the~     growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such~     as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab~     together with doxorubicin hydrochloride liposome may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab~     together with doxorubicin hydrochloride liposome works in treating women with locally~     recurrent or metastatic breast cancer.~   "
237583|NCT00445393|"~     The purpose of this pilot study is to determine the presence, frequency, and severity of~     mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.~   "
237584|NCT00445367|"~     To establish a large, longitudinal collection of high quality samples and data from subjects~     with MS, selected other demyelinating diseases (Transverse Myelitis (TM), Neuromyelitis~     Optica (NMO) or Devic's, Acute Disseminated Encephalomyelitis (ADEM), and Optic Neuritis~     (ON)), and related and unrelated unaffected controls. Samples and data will be available as a~     shared resource to scientists researching the causes, sub-types, and biomarkers of MS and~     related demyelinating diseases.~   "
237585|NCT00445354|"~     This study will randomize diabetics with hemoglobin A1c greater than 7.0 to receive either~     cinnamon plus usual care or usual care alone. Hemoglobin A1c will be measured at intake and~     after 90 days.~   "
237586|NCT00445341|"~     Background:~      Mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL) are aggressive subtypes~     of non-Hodgkin lymphoma.~      Flavopiridol is an investigational drug that works differently from standard chemotherapy and~     may target abnormalities in MCL and DLBCL cells, such as a protein excess that prevents tumor~     cells from dying.~      A challenge in developing flavopiridol for treatment has been determining its optimal dosing~     schedule. The schedule used for this study is effective in a type of leukemia called chronic~     lymphocytic leukemia (CLL) and may benefit patients with MCL and DLBCL also.~      Objectives:~      To determine the highest dose of flavopiridol that can be given safely to patients with~     relapsed MCL and DLBCL at the dosing schedule detailed below~      To assess the response of the tumor to flavopiridol given at the test dosing schedule~      Eligibility:~      Patients 18 years of age and older with relapsed MCL or DLBCL~      Design:~      Flavopiridol is given at four different dose levels, starting with the lowest dose for the~     first group of three to six patients and increasing with subsequent groups, depending on side~     effects at the preceding dose. The drug is given weekly for 4 weeks followed by a 2-week~     break (one cycle) for up to six cycles. It is given through a vein as a 30-minute infusion~     followed by a 4-hour infusion.~      Patients undergo the following procedures for research studies and to evaluate the effect of~     treatment on the tumor:~        -  Blood tests~        -  Lymph node, bone marrow and tumor biopsies~        -  Lymphapheresis to collect blood cells for research~        -  Disease staging with imaging studies (computed tomography (CT), positron emission~          tomography (PET) and/or magnetic resonance imaging (MRI) after every 2 cycles~   "
237587|NCT00445328|"~     The purpose of this study is to compare the efficacy and safety of dalteparin vs~     unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized~     acutely ill medical patients.~   "
237588|NCT00445315|"~     Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in~     HCV positive patient volunteers~   "
237589|NCT00445302|"~     Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy~     control subjects (aged 35 to 78 years) will be enrolled in the study. Subjects with renal~     impairment will be enrolled and entered into three groups based on their renal function: Mild~     Impairment, Moderate Impairment, and Severe Impairment(not requiring dialysis). Control~     subjects will have normal renal function.~      The screening visits will occur within 14 days prior to plerixafor administration on study~     day one. Subjects will be monitored for 10 hours following administration of the study drug.~     In addition, subjects will return to the clinic at 24 and 48 hours after plerixafor~     administration for blood samples and safety assessments.~   "
237590|NCT00445289|"~     This bicentric, randomized, controlled trial examines the effectiveness of an automatic~     control of pressure support ventilation (SmartCare/PS) in critically ill patients.~   "
237591|NCT00445276|"~     Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has~     already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at~     confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and~     validated criteria and according to the recommendations and guidelines for this kind of~     study.~   "
237602|NCT00445133|"~     HYPTHOTHESIS:~      The researchers hypothesize that application of active magnetic therapy vs. sham utilized~     while individuals sleep can reduce neuropathic pain in the spine and improve the quality of~     sleep. The null hypothesis is that treatment of subjects with spine pain with exposure to~     permanent/static magnetic fields has no measurable effect on neuropathic pain scores or~     quality of sleep scores.~   "
237603|NCT00445120|"~     This interventional study aims to evaluate the efficacy of oral administration of~     Lactobacillus Rhamnosus GG in preventing relapses of ocular inflammation in Vernal~     Keratoconjunctivitis (VKC) patients.~   "
237604|NCT00445107|"~     The purpose of this study is to assess the treatment effect of montelukast 10mg on the~     primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent~     asthma patients with or without allergic rhinitis.~   "
237605|NCT00445094|"~     The primary objective of this study is a comparison between MK0787B and standard therapy.~   "
237592|NCT00445263|"~     The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main~     evolutionary risk of these patients is the coronary thrombosis and its self complications.~     The platelets aggregation plays a major role in the physiopathology of the ACS. The~     therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has~     been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of~     these products in the ACS with or without ST elevation, associated or not to coronarography,~     has clearly been demonstrated. This profit is more marked when patients are at high risk of~     complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at high~     risk for whom a coronarography is planned, in the last international recommendations of the~     European Cardiology Society (ESC), the American Heart Association and the American College of~     Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on~     coronarography with discordant results. The ideal delay of realization of this coronarography~     is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again,~     patients at high risk seem to benefit the more of such a strategy if it is set precociously.~      Objective To compare an invasive strategy associating an early administration of tirofiban~     and a coronarography achieved in the 6 hours after the randomization to a conservative~     strategy in a population of high risk patients with ACS without ST elevation.~      Design Multicentric, prospective, randomized study.~   "
237593|NCT00445250|"~     Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo~     cutaneous side effect in patients receiving radiotherapy to the breast.~      To check the connection between the skin effect of radiotherapy and different parameters~     including diseases such as diabetes and lupus, use of medications, allergies, weight, habits,~     size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.~   "
237594|NCT00445237|"~     This study is evaluating the safety and feasibility of the novel deep TMS H-coil designs in~     the treatment of resistant major depression in an open study using two different H-coil~     designs.~   "
237595|NCT00445224|"~     Patellofemoral pain syndrome (PFPS) is a common knee disorder affecting physically active~     people. Despite the growing base of support for the early introduction of hip strengthening~     exercises into the rehabilitation of PFPS, there have been few randomized clinical trials~     comparing isolated hip to isolated quadriceps strengthening. The purpose of this study is to~     determine how different exercises affect pain, strength, muscle activity, and function in~     female subjects with patellofemoral pain. The researchers hypothesize that females diagnosed~     with PFPS who initially participate in a hip strengthening program will report a greater~     perceived level of function, greater strength, less pain, and improved neuromuscular activity~     than those who participate in a progressive quadriceps strengthening intervention.~   "
237596|NCT00445211|"~     Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump~     which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the~     work of the heart and improving blood flow to the coronary arteries) often receive~     intravenous (IV) heparin (a blood thinner) to prevent circulation problems in the leg~     (where they are inserted). When intra-aortic balloon pumps were initially developed, the~     catheters were larger than the catheters used today. Due to the large size of the catheter~     and the material used to make the catheter, it was thought that intravenous heparin would~     prevent poor blood flow to the leg that contained the temporary catheter. Intravenous~     heparin, however, has never been proven to maintain good blood flow in these patients. The~     catheters used with intra-aortic balloon pumps are now smaller in size and made of a material~     that is less likely to produce blood clots. It is not clear that heparin is needed with~     intra-aortic balloon pumps. Bleeding complications associated with intra-aortic balloon pumps~     may be decreased if heparin is not used. In 2004, 99 patients received intra-aortic balloon~     pumps in the cardiac catheterization labs at William Beaumont Hospital. These patients~     received intravenous heparin and experienced a large number of bleeding complications (27~     patients required a blood transfusion). This study will help the investigators to clarify if~     heparin should or should not be routinely used in patients with intra-aortic balloon pumps.~   "
237597|NCT00445198|"~     The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of~     ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose.~     (This portion of the study is complete). The Phase 2a portion of the study will evaluate~     ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a~     preliminary assessment of efficacy.~   "
237598|NCT00445185|"~     The current extension study will assess the persistence of anti-HBs antibodies at Months 12,~     24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol~     posting deals with the objectives & outcome measures of the extension phase at Months 12, 24~     and 36. The objectives & outcome measures of the primary phase are presented in a separate~     protocol posting (NCT00291941).~   "
237599|NCT00445172|"~     The purpose of this study is to investigate the safety and efficacy of long-term E0302~     administration in patients with Amyotrophic Lateral Sclerosis (ALS).~   "
237600|NCT00445159|"~     This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic~     lower limb rest pain related to advanced peripheral arterial disease. Rest pain is one of the~     primary management issues of severe arterial occlusive disease and may lead to amputation~     when the pain becomes intolerable and unresponsive to narcotic analgesia. Rest pain also~     impacts the quality of sleep and mobility with frequent interruptions in sleep and decreased~     mobility. Treprostinil sodium (Remodulin®) has been studies in several small open-label~     studies and has been shown to be safe as well as an effective agent for ischemic rest pain~     when given by subcutaneous or intravenous delivery. However, these forms of administration~     have patient convenience limitations, including the need for an infusion device and~     associated pain at the site of infusion with subcutaneous delivery. UT-15C may allow patients~     suffering from CLI to benefit from the simplicity of an oral dosage form~   "
237601|NCT00445146|"~     The main objective of this study is to observe the long-term safety of elvitegravir (EVG)~     boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in~     participants who have completed a prior EVG+RTV treatment study.~   "
237606|NCT00445081|"~     To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients~     with severe atopic dermatitis.~   "
237607|NCT00445068|"~     This study will evaluate the efficacy and safety of LBH589B in adult patients with multiple~     myeloma who have received at least two prior therapies and are refractory to their last~     therapy. Patients must have received in prior therapy either bortezomib or lenalidomide~   "
237608|NCT00445055|"~     In this prospective, randomised, placebo-controlled study, the researchers determined whether~     0.625 mg or 2.5 mg of IV droperidol given 30 min before emergence from general anaesthesia~     reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in~     thyroid surgical female population. Two hundred and forty six female patients receiving~     general anaesthesia for thyroid surgery received either droperidol 0.625 mg or droperidol 2.5~     mg or placebo before emergence.~   "
237609|NCT00445042|"~     The purpose of this study is to determine the safety and toxicity levels of Dose Escalated~     Sorafenib in the treatment of patients with renal cancer.~   "
237610|NCT00445029|"~     The current knowledge of the pathophysiology of allergic contact dermatitis is based on the~     murine model. In this model, CD8+ T cells are effector cells, and CD4+ T cells regulate the~     response by limiting the expansion of CD8+ T cells. The goal of this study is to characterize~     the pathophysiology of contact dermatitis, with patients allergic to para-phenylenediamine~     (PPD).~      We suppose that the CD8+ T cells are the effectors of the allergic contact dermatitis,~     although the regulator cells belong to the LT CD4+ population. We will test our hypothesis on~     blood samples, and cutaneous biopsies of patients allergic to PPD.~   "
237611|NCT00445016|"~     To evaluate the incidence of neurologic complications as a consequence of peripheral regional~     anesthesia, all patients receiving peripheral nerve blocks will be evaluated according to a~     standardized protocol screening pain, motoric and sensory function recovering to defined~     periods, and according to a study protocol defining the items.~   "
237612|NCT00445003|"~     The purpose of the study is to find out if treatment with an intravitreal injection of~     triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused~     by panretinal photocoagulation treatment. At the present time, it is not known whether~     intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections are~     beneficial in preventing vision loss after panretinal photocoagulation (PRP) treatment. It is~     possible that one or both of the types of injections will prevent vision loss after PRP~     treatment. However, it is not known whether the benefits of the injections will outweigh the~     risks. It is possible that because of side effects, the injections may not be as good as~     laser alone in treating the diabetic retinopathy.~   "
237613|NCT00444990|"~     OBJECTIVE:~      The objective of this study is to determine if treatment with a flex pad impregnated with~     static/permanent magnets that can penetrate over 70 mm may improve the quality of chronic~     lumbar pain with reduction of pain scores.~      HYPOTHESIS:~      The researchers hypothesis that the application of a flex pad active magnetic therapy vs.~     sham if utilized daily during waking hours can reduce back pain and/or radicular pain. The~     null hypothesis is that treatment of subjects with chronic back pain with exposure to~     static/permanent magnetic fields have no measurable effect on chronic back pain scores and~     will be equal to the underlying placebo.~   "
237614|NCT00444977|"~     The purpose of this study is to investigate the efficacy of a case management linkage~     intervention designed to increase utilization of oral health care services among HIV+~     individuals enrolled in HIV primary care that have not seen a dental provider in the~     preceding twelve months.~   "
237615|NCT00444964|"~     The main research question this protocol aims to answer is whether treatment with growth~     hormone will impact body composition, quality of life, and energy balance in PWS adults, and~     if there is a loss of effects after cessation of treatment for at least 12 months.~   "
237616|NCT00444951|"~     This study will be conducted among adolescents in Saudi Arabia who previously received one~     dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine.~     This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and~     W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax®~     (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal~     antibody responses.~   "
237617|NCT00444938|"~     This study is evaluating the potential antidepressive effect of a 4 week treatment protocol~     using the H-coil deep TMS device in bipolar depression.~   "
237618|NCT00444925|"~     To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo~     for overactive bladder~   "
237619|NCT00444912|"~     Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one~     of 2 arms based on the immunophenotype of their lymphoma.~      (A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte~     colony-stimulating factor (G-CSF) and plerixafor.~      (B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and~     plerixafor. They will receive a weekly dose of rituximab beginning 1 week prior to, and~     continuing until 2 weeks after, the first dose of G-CSF.~      Participants in both groups will receive G-CSF twice daily for 4 days. In the evening on Day~     4, a dose of plerixafor will be administered. Apheresis will be initiated the next morning.~     Participants will continue to receive G-CSF twice daily and to receive the evening dose of~     plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until~     ≥5*10^6 CD34+ cells/kg are collected.~      Participants who are transplanted will be monitored for the time to polymorphonuclear~     leukocytes (PMN), platelets (PLT), and lymphocyte engraftment. Follow-up assessments will be~     done at 100 days, and 6 and 12 months post-transplantation.~   "
237636|NCT00444691|"~     It has been reported recently that the detection of synovitis by ultrasonography was more~     sensitive than clinical examination (Wakefield et al. Ann Rheum Dis).~      An OMERACT and EULAR working party recently produced guidelines on the best way to record and~     score quantitatively synovitis of the small joints of the hands and feet (Wakefield R,~     D'Agostino MA).~      It has also been presumed recently that ultrasonography was more sensitive to changes than~     clinical examination after anti-TNF treatment (Ref. Taylor et al). If this better sensitivity~     to change were to be confirmed, ultrasonography would be preferred to clinical examination in~     studies evaluating new treatments.~      In everyday practice, better intrinsic validity of the evaluation of synovitis by~     ultrasonography would lead to widespread use of this technique in the diagnosis and treatment~     of rheumatoid arthritis patients.~      Objective of this study is to compare the sensitivity to change in synovitis score according~     to the monitoring method used (clinical examination versus ultrasonography).~   "
237620|NCT00444899|"~     Worldwide, health systems and practitioners are facing obesity epidemics. High blood~     pressure, dyslipidemia and diabetes prevalence will explode during the 21st century.~      The two main objectives of this 2-year controlled prospective study are:~        1. to demonstrate that, for patients with high blood pressure, diabetes and dyslipidemia,~          dietician conducted survey and management in combination with annual endocrinologist~          follow-up enable both attainment and maintenance of recommended blood pressure, glycemic~          and lipid goals, as well as smoking cessation;~        2. to demonstrate that dietician management is more cost effective than conventional care~          provided by general practitioners and endocrinologists.~      Results are expected to show significantly different cardiovascular risk profiles (BMI and~     waist circumference, systolic and diastolic blood pressure, LDL-C, triglycerides and Total~     cholesterol/HDL ratio, HbA1c, smoking) between baseline and after 2 years follow-up. Sample~     size was determined in order to show statistically significant differences between the two~     groups.~      Results will document for the benefit of care givers, health economists and policy makers~     alike an innovative and integrated model of care which is expected to be effective at the~     patient level as well as cost effective with respect to the increasing financial burden of~     diabetes on the health system.~   "
237621|NCT00444886|"~     The purpose of this study is:~        1. To assess the effect of BOTOX injection to the scalene muscles on the severity of pain~          from TOS.~        2. To assess the effect of BOTOX injection on numbness and tingling and quality of life.~   "
237622|NCT00444873|"~     A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy~     and safety of different dose-intervals of Lanreotide Autogel 120mg according to international~     standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.~   "
237623|NCT00444860|"~     The purpose of this study is to obtain safety and immunogenicity data for the~     refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.~   "
237624|NCT00444847|"~     The exposure of human beings to markedly altered environments (ambient pressure and inhaled~     gas mixtures) has profound effects on their innate immune capacity to effectively combat~     viral illnesses. This Phase IIA clinical trial examines the effects of an exposure to a 4~     atmospheric environment has on HIV-infected humans whose clinical condition has progressed to~     formal AIDS status.~   "
237625|NCT00444834|"~     The purpose of this study is to compare the efficacy of the Egalet® controlled release~     formulation to an immediate release Carvedilol tablet.~   "
237626|NCT00444821|"~     The purpose of this study is to compare endovascular repair using any FDA approved Medtronic~     AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic~     aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.~   "
237627|NCT00444808|"~     This study, which will be conducted at the emergency room of the Sacré-Cœur hospital,~     requires the recruitment of 60 subjects and involves some telephone follow-up.~      Calcitonin administered as an intranasal spray is already used to relieve pain caused by~     broken vertebrae and we seek to determine if it can be as efficient in the case of pain~     caused by broken ribs.This study aims at testing the hypothesis that subjects suffering from~     the accidental fracture of one or more ribs will get relief through the intranasal spraying~     of calcitonin and/or will use less opiate medication for pain relief (a combination of~     oxycodone chlorhydrate and acetaminophen called Percocet®).~   "
237628|NCT00444795|"~     To monitor use in real practice including adverse events and efficacy on Sutent capsules~     (Sunitinib malate)~   "
237629|NCT00444782|"~     The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or~     metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated.~   "
237630|NCT00444769|"~     This phase IIa (proof of concept) study will be conducted as a multi-centre study within the~     European Union (EU). It will be conducted to a randomised, single blind, placebo- controlled,~     parallel group design with a positive control arm to evaluate the analgesic efficacy of~     pre-emptive doses of GW842166 following dental surgery (3rd molar tooth extraction). GW842166~     will be administered as a single pre-operative oral dose in male and female subjects who will~     be randomised to take part in one of four possible treatment regimens. Pain assessments will~     be undertaken over a 10 hr period. Pharmacokinetic blood samples will be collected over a 48~     hr period. Safety and tolerability will be evaluated by adverse event monitoring,~     cardiovascular assessments (ECG and vital signs) and clinical laboratory tests (haematology,~     clinical chemistry and urinalysis).~   "
237631|NCT00444756|"~     This trial is a comparison of the anesthetic effectiveness of J-Tip needle-free jet injection~     of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for peripheral~     intravenous catheter (PIV) insertion. The researchers hypothesize that the jet injection of~     lidocaine will provide superior anesthesia to the ELA-Max prior to PIV insertion.~   "
237632|NCT00444743|"~     The purpose of this study is to evaluate the tolerability, pharmacokinetics,~     pharmacodynamics, and biologic activity of MM-093 in patients with moderate to severe~     uveitis.~   "
237633|NCT00444730|"~     The purpose of initiating the urology database is to collect relevant retrospective data via~     chart review related to patients undergoing radical prostatectomy via the retropubic,~     perineal, laparoscopic, and robotic assisted laparoscopic approaches and InterStim~     implantation. This data will be utilized to evaluate the health benefits and outcomes of each~     of these procedures to enhance care and treatment.~   "
237634|NCT00444717|"~     The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of~     pitavastatin in hypercholesterolemic patients with the metabolic syndrome.~   "
237635|NCT00444704|"~     The primary purpose of this study is to assess the safety and tolerability of ascending~     single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide~     the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese~     female subjects.~   "
237637|NCT00444678|"~     This trial will examine the addition of Cetuximab in combination with Oxaliplatin and~     Capecitabine for treatment of patients with previously untreated metastatic colorectal~     cancer.~   "
237638|NCT00444665|"~     Examine the safety, tolerability and efficacy of travoprost benzalkonium chloride (BAK) free~     ophthalmic solution compared to either latanoprost or bimatoprost monotherapy.~   "
237832|NCT00442377|"~     The objective of the study is to induce a protective immune response against malaria in~     healthy human volunteers. The different parts of the immune response will then be studied.~   "
237639|NCT00444652|"~     This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types~     of bariatric surgery.~      - gastric banding and gastric bypass on anti-Xa activity levels~      The study includes two groups of 150 patients scheduled for gastric banding or gastric~     bypass.~      Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order~     to determine the best prophylactic regimen allowing expected values ranged between 0.3 and~     0.5 IU / ml.~   "
237640|NCT00444639|"~     The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for~     a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is~     a hormone secreted by hypothalamus (a gland located in brain) and controls the production of~     sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate~     cancer cells, one of the most common cancers in men, is induced by the hormone testosterone.~     Hormonotherapy is one of treatments available to treat this type of disease by controlling~     the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this~     type of injection is not suitable for every patient. Therefore the primary purpose of this~     study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin®~     11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg~     administered via standard intramuscular (IM) injection based on the percentage of patients~     presenting a testosterone level ≤ 50 ng/dl at week 24.~   "
237641|NCT00444626|"~     The purpose of this research study is to evaluate the safety and effectiveness of injection~     with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery)~     as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal~     filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).~   "
237642|NCT00444613|"~     The purpose of this study is to investigate the efficacy and confirm the safety of E0302 in~     patients with Amyotrophic Lateral Sclerosis (ALS) by assessing changes in scores of survival~     rate and functional rating scale.~   "
237643|NCT00444600|"~     The purpose of the study is to find out which is a better treatment for diabetic macular~     edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone,~     laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of~     ranibizumab alone. At the present time, it is not known whether intravitreal steroid or~     anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser~     treatment, are better than just laser by itself. It is possible that one or both of the types~     of injections, with or without laser treatment, will improve vision more often than will~     laser without injections. However, even if better vision outcomes are seen with injections,~     side effects may be more of a problem with the injections than with laser. Therefore, this~     study is conducted to find out whether the benefits of the injections will outweigh the~     risks.~   "
237644|NCT00444587|"~     This 2 arm study will compare the efficacy and safety of continuation or discontinuation of~     Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive~     metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus~     Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment~     (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the~     investigator's choice. The anticipated time on study treatment is until disease progression,~     and the target sample size is 100-500 individuals.~   "
237645|NCT00444574|"~     Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference~     to CONCERTA® in pediatric subjects diagnosed with ADHD.~   "
237646|NCT00444561|"~     This exploratory study is designed to evaluate various pharmacodynamic effects of~     subcutaneously (SC) infused or injected pramlintide in obese, nondiabetic male and~     postmenopausal female (not on hormone replacement therapy) subjects. The study will also~     assess the safety and tolerability of pramlintide administered by SC infusion or injection.~   "
237647|NCT00444548|"~     [S,S]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in~     healthy volunteers using a novel methodology~   "
237648|NCT00444535|"~     This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with~     ErbB2-overexpressing breast cancer.~   "
237649|NCT00444522|"~     We are developing Staccato Alprazolam for the acute treatment of panic attacks associated~     with panic disorder.~   "
237650|NCT00444509|"~     This is a single centre, randomised, double blind, two-way crossover study, to investigate~     the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder~     GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to~     improve the physical stability of inhaled dry powder formulations. Male and female patients~     with mild/moderate asthma will be randomised to determine which order they receive a single~     inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will~     be a wash-out period of at least 5 days between doses.~   "
237651|NCT00444496|"~     We are collecting baseline data on patients who have high blood pressure readings (160/100 or~     higher) at a 9-1-1 response by an EMT.~   "
237652|NCT00444483|"~     The improvement of the quality of life (QoL) is one of the key treatment goals in patients~     with diabetes mellitus. Objective: Prospective study to evaluate the impact of structured~     diabetes education on the QoL in insulin-treated, elderly patients with type 2 diabetes~     mellitus. Inpatients with insulin treated type 2 diabetes or failure of oral antidiabetic~     therapy were successively recruited and participated in the structured inpatient diabetes~     treatment and teaching program (DTTP) for insulin therapy QoL was assessed before and six~     months after participation in the DTTP with the standardised questionnaire of Lohr analysing~     the subscales: social relations, physical complaints, worries about the future, diet~     restrictions, fear of hypoglycemia, and daily struggles.~   "
237653|NCT00444470|"~     Spinal fusion surgery can be associated with significant blood loss requiring allogeneic~     blood transfusion. Tranexamic acid is a synthetic amino acid with antifibrinolytic action~     that has been shown to reduce perioperative blood loss in patients undergoing cardiopulmonary~     bypass for cardiac bypass surgery, knee replacement and liver transplantation surgeries. The~     efficacy of antifibrinolytics for reduction of blood loss in major spine surgery has not been~     well studied in adult patients. The objective of this study is to determine the efficacy of~     tranexamic acid in reducing perioperative blood loss and blood transfusion in adults~     undergoing elective spinal fusion in a larger, multi-centered, randomized, double-blinded,~     placebo controlled trial.~   "
237654|NCT00444457|"~     The purpose of this study will be to evaluate safety, tolerability and immunogenicity of~     three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied~     for consistency of the immune response, as well as for non-inferiority and safety as compared~     to 7-valent Pneumococcal Conjugate Vaccine.~   "
237655|NCT00444444|"~     To determine whether certain alleles or haplotypes of major histocompatibility complex gene~     are associated with AIP in Korean population, we undertook this study with high-resolution~     typing for HLA (sequence-based typing).~      Primary outcomes: detection of novel allele associated with AIP in Korean population~     Secondary outcomes: detection of genetic factor for relapse of AIP during steroid treatment~   "
237656|NCT00444431|"~     In this randomized trial surgical therapy and surveillance of ureteropelvic junction~     obstruction will be compared, regarding partial renal function.~   "
237657|NCT00444418|"~     The purpose of this study is to study the effectiveness of medication and specialized~     psychotherapy in helping gay and bisexual men who do not want to quit drinking learn how to~     reduce their drinking to healthier levels. More information on the study is available at~     www.projectsmartnyc.org.~   "
237658|NCT00444405|"~     The purpose of this study is to compare patients who underwent decompression/discectomy with~     pedicle screw fusion to patients who received decompression/discectomy without fusion.~   "
237659|NCT00444392|"~     Central hypothesis is: Gastric bypass surgery reduces the risk of CVD in morbidly obese~     subjects (defined as BMI ≥35 kg/m2) with T2DM.~      To determine whether surgically induced weight loss decreases the risk of CVD in morbidly~     obese subjects with T2DM. I hypothesize that patients with T2DM who undergo gastric bypass~     surgery will significantly reduce mean levels of risk factors for CVD compared with diabetic~     individuals with the same BMI who maintain their weight.~   "
237660|NCT00444379|"~     The primary purpose of this study is to determine whether a protease inhibitor-based~     antiretroviral regimen is more efficacious than a non-nucleoside reverse transcriptase~     inhibitor-based antiretroviral regimen in promoting the regression of KS tumor burden in~     persons with AIDS-related KS in Africa.~   "
237661|NCT00444353|"~     This study is being undertaken to:~        -  evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic~          acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment~          of dermal nasolabial fold wrinkles at 13 months following the last application of study~          treatment.~        -  Document the types and incidence of adverse events reported with DL6049 (injectable~          poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events~          will be assessed for an additional 12 months following discharge from the main study in~          subjects treated with DL6049.~   "
237662|NCT00444340|"~     This study is an extension trial of 0881A3-312-EU and is designed to provide information on~     the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3~     additional years.~   "
237663|NCT00444327|"~     The aim of our study was firstly to detect in cord bloods the polymorphism of genes related~     to atopy and allergic diseases and to examine their mutual interaction and their associations~     with cord blood IgE and cytokines. After that, in the prospective follow-up visits, we liked~     to investigate if the measurement of cord blood SNPs of genes related to atopy and allergic~     diseases was helpful in predicting the development of atopy and allergic diseases later in~     life.~   "
237664|NCT00444314|"~     This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and~     pharmacodynamics, of Panzem® NCD with or without Sunitinib Malate in patients with metastatic~     renal cell carcinoma progressing on Sunitinib Malate.~   "
237665|NCT00444301|"~     Heart failure, a chronic illness afflicting 5 million persons in the United States is known~     to cause shortness of breath and fatigue, yet at least half of persons with heart failure~     also report the presence of pain.~      The cause of pain for these persons is not clear. PAIN-HF (Pain Assessment, Incidence &~     Nature in Heart Failure), conducted through the Palliative Care-Heart Failure Education And~     Research Trials (PC-HEART) collaborative will identify the prevalence of pain, its location,~     severity and impact on activities and the possible causes of pain in persons living with~     heart failure. The study will also try to understand relationships between other problems and~     pain, as well as what treatments are given to reduce pain.~      Understanding sources of pain and its characteristics is the first step in helping health~     care providers better manage pain and related problems in persons with heart failure.~   "
237666|NCT00444288|"~     Polycystic Ovary Syndrome, or PCOS, is the most common endocrine disorder in women. Depending~     on the strictness of the diagnostic criteria used, it is thought to occur in about 6-10% of~     all women, many of whom do not know they have the syndrome. Women with PCOS produce~     abnormally high levels of male hormones (hyperandrogenism); this counteracts their ovaries'~     ability to make enough of the female hormones estrogen and progesterone needed for normal~     menstruation. PCOS is the number one cause of hormonally related infertility and also~     increases women's risks for diabetes, high blood pressure, hypercholesteremia, cardiovascular~     disease and certain cancers. It is currently unclear to what extent PCOS and PCOS-associated~     traits (hyperandrogenisms, hyperinsulinemia, insulin resistance, type 2 diabetes,~     dyslipidemia, hypertension, obesity, and coronary artery disease) are the results of~     environmental factors or genetic predisposition. Therefore, the NIEHS Program in Clinical~     Research is conducting a multi-phase twin study to measure the extent of PCOS heritability~     and to identify environmental and genetic factors involved in the development of PCOS. The~     proposal described here is for Phase 2 of this study. The goals of Phase 2 are to: 1)~     establish more reliable concordance rates and baseline heritability estimates for PCOS in MZ~     and DZ twins; and 2) establish a cohort of intact MZ and DZ female twin pairs as a resource~     for future studies.~      In Phase 1, about 1500 individual female twins were identified from the Mid-Atlantic Twin~     Registry (MATR) based on self report of a history of irregular periods and/or cystic ovaries~     in the MATR General Health Screening Questionnaire. Those twins were surveyed by phone for~     other traits associated with PCOS. In Phase 2, the twins most likely to have PCOS based on~     their answers to the Phase 1 phone survey will be recontacted for further PCOS screening.~     This includes providing a blood sample for measuring bioavailable testosterone (BaT) levels.~     Women with elevated BaT levels are likely to have PCOS. The women with elevated levels will~     then be asked to undergo a medical evaluation for PCOS confirmation. This includes a physical~     exam, medical history, ultrasound, 2-hour glucose tolerance and other biochemical blood~     tests, and a Ferriman-Gallwey evaluation for abnormal hirsutism (another characteristic of~     PCOS). The women will also be tested for pregnancy and zygosity. Their female co-twins will~     be invited to undergo...~   "
237667|NCT00444275|"~     To compare the efficacy of three different long-term treatment strategies of reflux disease~     in primary care setting.~   "
237668|NCT00444262|"~     The aim of this study is to assess whether intra-operative fluid supplementation (to improve~     tissue perfusion) can reduce the incidence of postoperative complications in elderly patients~     with hip fracture.~   "
237833|NCT00442364|"~     The purpose of this study is to determine the safety of the Varisolve® procedure in patients~     with right-to-left cardiac shunt (a defect in the heart).~   "
237669|NCT00444249|"~     The blue light hazard has been reported to cause retinal damage (oxidative stress),~     particularly to the central fovea due to its energetic, shorter wavelength visible photons,~     which is why blue-light filtering intraocular lenses have been developed for cataract~     surgery. The hormone melatonin has been reported to possess an efficient antioxidant~     capacity. Light information from the eye reaches the suprachiasmatic nuclei and inhibits~     melatonin secretion. Since melatonin is suppressed by light, we have a day-night rhythmicity,~     with increased levels at night. Melatonin suppression is wavelength-dependent with a peak~     sensitivity in the 446-477 nm (blue light) portion of the visible spectrum. The crystalline~     lens blocks most UV between 300 and 400 nm. The density of the lens increases with aging~     causing an alteration in the spectral absorption. The greatest increase in absorption occurs~     at the short wavelength end of the spectrum (around 400-470 nm). Age-related pupillary miosis~     and crystalline lens yellowing limit the blue light reaching the retina. This reduces the~     older adults' effective retinal light exposure to one tenth that of younger people. It has~     been shown that insomnia and depression decrease after cataract surgery and patients returned~     to youthful levels of melatonin. Since melatonin acts as an antioxidant, and more blue light~     filtering intra ocular lenses are implanted and thought to reduce photochemical damage in the~     macula, it would be interesting to show the positive influence of those blue light filtering~     intraocular lenses on daytime levels of melatonin in age-related macular degeneration~     patients.~   "
237670|NCT00444236|"~     We propose that acid reflux affects respiratory dynamics (breathing) in patients who are~     exercising and that athletes improve their exercise capacity with acid suppression therapy.~     It is our intent to determine whether treatment of GER with strong acid suppression may~     alleviate symptoms, improve exercise capacity, and improve quality of life.~   "
237671|NCT00444223|"~     RATIONALE: Fluorine F 18 FEQA may be an effective radioactive drug to use with positron~     emission tomography (PET) scans.~      PURPOSE: This clinical trial is studying the use of fluorine F 18 FEQA in patients with stage~     III or stage IV non-small cell lung cancer and in healthy participants.~   "
237672|NCT00444210|"~     This study is being undertaken to:~        -  evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic~          acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment~          of dermal nasolabial fold wrinkles at 13 months following the last application of study~          treatment.~        -  Document the types and incidence of adverse events reported with DL6049 (injectable~          poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events~          will be assessed for an additional 12 months following discharge from the main study in~          subjects treated with DL6049.~   "
237673|NCT00444197|"~     Study Aims: 1) Assess the receptiveness of youth and families to injury prevention~     interventions initiated from the emergency department; 2) In a sample of high risk youth~     presenting to the ED with interpersonal assault injuries, determine the effectiveness of a~     home-based family intervention with community linkage compared to a control group.~   "
237674|NCT00444184|"~     This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus~     travoprost when both medications are dosed in the evening. Such a crossover comparison may~     determine the real efficacy of the new fixed combination versus travoprost monotherapy. The~     results should enhance the investigators understanding on the best dosing of TTFC and may~     influence its clinical use in Europe. Finally, the results would better delineate the future~     role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with~     PG analogs and timolol. This study should assist the general ophthalmologist worldwide to~     plan optimal stepwise medical therapy.~   "
237675|NCT00444171|"~     Randomized controlled trial to compare blood glucose control by the model predictive control~     algorithm with variable sampling rate (eMPC) with routine glucose management protocol (RMP)~     in peri- and postoperative period in cardiac surgery patients.~   "
237676|NCT00444158|"~     MOA-728, an investigational drug, is currently being studied for the relief of constipation~     associated with postoperative ileus and treatment of opioid induced constipation in patients~     receiving palliative care. This study will further investigate the IV formulation of MOA-728~     comparing PK/PD time points for a 20-minute versus a 4-hour infusion.~   "
237677|NCT00444145|"~     The purpose of the study is to determine if tissue changes are predictor of clinical response~     to therapy.~      The hypothesis is that the patients who have laryngeal signs and symptoms related to acid~     reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of~     response to therapy.~   "
237678|NCT00444132|"~     Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in~     patients with coronary artery disease. In the proposed study we wish to prospectively assess~     the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with~     clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients~     who demonstrate non-responsiveness to clopidogrel.~   "
237679|NCT00444119|"~     The purpose of this survey is to assess patients with chronic primary or secondary adrenal~     failure regarding subjective health status, incidence and causes of adrenal crisis, hormone~     replacement regimens and concomitant endocrine or non endocrine disease.~   "
237680|NCT00444106|"~     To evaluate the potential effects of artemether- lumefantrine on the auditory function~   "
237681|NCT00444093|"~     Therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as~     a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a~     common problem in multimodal cancer therapy. We investigate the therapeutic effect of either~     loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation~     therapy of the small pelvis with or without chemotherapy.~   "
237682|NCT00444080|"~     A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to~     trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to~     medical treatment and for which filtering surgery is indicated~   "
237683|NCT00444067|"~     To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of~     care techniques.~   "
237721|NCT00443573|"~     This is a multicenter, two-stage trial with the goal of evaluating up to 100 subjects. This~     trial will be performed to initiate identification of a safe and effective dose of~     twice-weekly, subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal~     carcinoma in combination with contemporary 5-FU-based chemotherapy.~   "
237684|NCT00444054|"~     This study is for people whose cancer:~        -  has resisted chemotherapy~        -  are taking a break from chemotherapy~        -  or are looking for an alternative to the toxic effects of chemotherapy~      The trial is looking to see if a very low carbohydrate diet can inhibit the growth of certain~     cancers.~      The two major goals of the RECHARGE study are to determine:~        -  whether a very low carbohydrate diet can help participants reduce the amount of cancer~          in their bodies (as measured by a PET scan at the beginning and end of the study)~        -  whether participants can feel well while maintaining their weight on a very low~          carbohydrate diet~      This research study is for people with advanced cancers who decline chemotherapy or want to~     take a break from chemotherapy and have cancers that primarily feed on blood sugar. Examples~     of such cancers include metastatic breast cancer, colon cancer, cervical and uterine cancers,~     ovarian cancers, and many others.~      The investigators' intervention consists of a 28-day diet of high protein foods such as fish,~     poultry, meats, eggs and cheese as well as plenty of vegetables. Participants may eat as much~     of the high protein foods as they wish and can eat up to two cups of vegetables per day.~      Participants strictly eliminate carbohydrate-containing foods. These foods include all~     starches and sweets (breads, pasta, rice, potatoes, cereals, fruit, cakes, candies, soda with~     sugar, etc.).~   "
237685|NCT00444041|"~     Major attempt is being given to the potential of curing patients with metastatic colorectal~     cancer due to the recognition of dramatic change in survival figures achieved in palliative~     chemotherapy combination treatment protocols. Achieving resectablity rates in previously~     unresectable patients has been defined as study endpoint among other well known primary and~     secondary objectives. Curing metastatic colorectal cancer is most likely in resectable~     patients and therefore the logical next step after completion of chemotherapy combination~     studies (e.g. EORTC 40983) is the addition of targeted agents. Bevacizumab has the most valid~     data of improving outcome figures and was therefore chosen as additional agent. Safety of the~     combination with Xelox was demonstrated in the investigators pilot trial (Gruenberger JCO~     2006, ASCO 2006, WCGC 2006, ESMO 2006), consequently response rate and resection rate will be~     the primary endpoints in this trial.~      STUDY OBJECTIVES~      Primary Objective The primary objective of this study is the Resectability (R0) rate after~     neoadjuvant Bevacizumab in potentially resectable mCRC.~      Secondary Objectives The secondary objectives of this study include~        -  Feasibility with regards to GI bleeding and wound healing complications after surgery of~          liver metastases~        -  General safety~        -  Overall Response Rate (ORR)~        -  Recurrence Free Survival (RFS)~        -  Overall Survival (OS)~      STUDY DURATION Recruitment is planned for 12 months. Patients will be treated for 6 cycles~     XELOX and 5 cycles Bevacizumab. Surgery will be performed 2 weeks after the last Capecitabine~     administration, allowing a time window of 5 weeks between the last Bevacizumab administration~     and surgery.~      Therapy with 6 cycles of XELOX and Bevacizumab will be restarted 4-5 weeks after surgery.~      With a Follow up period of 2 years after the last enrolled patient, in order to assess RFS~     and OS, the trial will last for approx. 3 years.~      NUMBER OF CENTRES Four centres with a high level of experience in the surgery of liver~     metastases are planned to participate in this study.~      SELECTION CRITERIA~      Total Number of Patients and Target Population The planned total sample size for this study~     is 43 patients. Patients with potentially resectable metastatic colorectal cancer previously~     untreated for metastatic disease will be enrolled in this trial.~   "
237686|NCT00444028|"~     Staccato Loxapine is being developed for the treatment of acute agitation in patients with~     schizophrenia. A 50 patient, dose escalation Phase I clinical trial was completed in November~     2005.~   "
237687|NCT00444015|"~     This is a single site phase I dose escalation trial of the epidermal growth factor receptor~     inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with~     previously treated advanced stage (Stage IIIB/IV disease) Non-Small Cell Lung Cancer (NSCLC).~     The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets~     starting Day 9 for a 28-day cycle. If there are no Dose Limiting Toxicities (DLTs), dose~     escalation continues. The recommended phase II dose for this combined treatment will be~     defined and patients will be treated at the recommended phase II dose to confirm~     tolerability.~   "
237688|NCT00444002|"~     Hepatitis C virus infection (HCV) is a major health concern in Canada and worldwide. Chronic~     HCV can cause progressive liver damage leading to inflammation, scarring and, in some cases,~     cirrhosis or liver cancer. It has been shown that fat accumulation in the liver can~     accelerate the disease progression and is therefore a risk factor in HCV patients.~      However, the exact mechanism(s) by which fat accumulation in the liver is involved in disease~     progression are not clear yet. It is possible that the presence of fat provides a liver~     susceptible to a second injurious process which leads to scarring. Candidates for this second~     hit may include insulin resistance, leading to accumulation of fat within the liver cells~     and secondly oxidation of these lipids. In turn, lipid peroxidation can lead to production of~     reactive oxygen species (unstable molecules that can damage cells) and cytokines (signal~     molecules that promote inflammation) resulting in more oxidative stress and liver damage.~      Aim of the study is to find out, whether patients with HCV and fatty liver have increased~     oxidative stress and inflammation than patients with HCV without fatty liver, and whether~     this is associated with a different nutritional status.~   "
237689|NCT00443989|"~     We will conduct a prospective cohort study evaluating the incidence of and optimal risk~     estimation model for major perioperative cardiovascular events in consecutive patients~     undergoing noncardiac surgery at the 'Herlev University Hospital'. This national pilot study~     in Denmark together with other national studies will inform the feasibility of a large~     prospective international cohort study.~   "
237690|NCT00443976|"~     RATIONALE: Aurora kinase inhibitor AT9283 (AT9283) may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in treating~     patients with advanced or metastatic solid tumors or non-Hodgkin's lymphoma.~   "
237691|NCT00443963|"~     We hypothesize that patients receiving NSAID drugs with dyspeptic symptoms have increased~     production of gastric levels of free radicals. The primary objective of the study is to~     determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and~     decreases gastric free radical production in humans. Patients (age 18 years and older) with~     no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and~     then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All~     eligible individuals will undergo biopsies of antrum and corpus. The subjects will be~     randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all patients will~     undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will~     then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an~     indirect marker of free radical production).~   "
237719|NCT00443599|"~     Critically ill children, including children undergoing heart surgery, commonly develop~     elevated blood glucose (also known as blood sugar) levels during their illness, which can~     lead to poor health outcomes and an increased risk of death. This study will examine the~     effectiveness of maintaining normal blood glucose levels at decreasing infections and~     improving recovery in young children undergoing heart surgery.~   "
237692|NCT00443950|"~     The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA)~     the efficacy and safety in this subject population of 50 mg once-weekly injections of~     etanercept versus placebo in subjects receiving methotrexate. This is a multi-center,~     double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150~     subjects will participate in this study for about 18 weeks including a screening period up to~     4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.~   "
237693|NCT00443937|"~     Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent~     graft rejection, can cause renal impairment in some patients. The aims of this study are~        -  To determine the influence of CNI discontinuation on the drug exposure and key~          pharmacokinetic parameters of everolimus and enteric-coated mycophenolate sodium~          (EC-MPS)~        -  To determine the adequate dosing of everolimus and EC-MPS in a CNI-free regimen~        -  To investigate the CNI-free regimen with EC-MPS and everolimus with respect to safety~          (e.g. rejection rates) and tolerability~        -  To investigate renal function after CsA withdrawal~   "
237694|NCT00443924|"~     The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic~     Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma~     and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic~     Solution.~   "
237695|NCT00443911|"~     Age-related macular degeneration is one of the major causes of blindness in the western~     world. There is an exsudative and a non-exsudative form of age-related macular~     degeneration.Most studies concentrate on the exsudative form. In the non-exsudative form the~     policy is generally watch and see, but patients are at risk to develop an exsudative form. So~     far, the only accepted therapy to reach stable disease in the non-exsudative form is~     high-dose supplementation of antioxidants. Another approach to improve visual acuity in~     patients with non-exsudative form of macular degeneration is rheohemapheresis treatment, an~     extracorporeal therapy where plasma is separated from blood cells. By the use of a hollow~     fiber filter plasma is depleted of high molecular weight proteins and reinfused. Others~     report describe the supplementation of lutein (a vitamin A derivative) as possible treatment~     option. However, none of the studies have yet examined a combination of rheohemapheresis and~     lutein supplementation.~   "
237696|NCT00443898|"~     This study is designed to assess the efficacy, safety and tolerability of a topical~     formulation of terbinafine solution applied daily in patients with toenail fungus. This trial~     will study patients with mild to moderate toenail fungus disease of the big toenail and their~     responses to two treatment durations, 24 or 48 weeks.~   "
237697|NCT00443885|"~     The isolate samples will be collected over a period of one year once IRB approval has been~     obtained. These isolates were collected as part of the patient's clinical care and once all~     clinical testing is complete, all isolates will be discarded. The honest broker of our area~     will collect the isolates and deidentify all information once all clinical testing is~     complete. The isolates will be obtained from the microbiology lab.~   "
237698|NCT00443872|"~     The purpose of the study is to determine if reducing or eliminating a dopamine agonist (DA)~     causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet,~     hallucinations or impulsive behaviors while adding orally disintegrating selegiline can~     eliminate the adverse effect and maintain control of Parkinson's disease (PD) symptoms.~   "
237699|NCT00443859|"~     Babies who are suspected of having persistent pulmonary hypertension (PPHN) will be included~     in this study. PPHN is a condition in which the blood is restricted from flowing to the lungs~     in a normal way making it hard for babies to breath and placing strain on the heart. This~     study will observe whether certain hormones that measure stress (N-terminal pro-brain~     natriuretic peptide) can help determine how well a baby will do when they have PPHN.~   "
237700|NCT00443846|"~     Primary objective:~      To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine~     without impairing the efficacy of MCC vaccine.~      Secondary objectives:~        -  Efficacy: Additional immunogenicity assessments.~        -  Safety: To describe the safety profile of RotaTeq® and of the MCC vaccine when~          administered concomitantly with RotaTeq®.~   "
237701|NCT00443833|"~     Thyrotoxic periodic paralysis (TPP) is characterized by episodes of reversible hypokalemia~     and weakness in thyrotoxic patients. It is commonly found in males of Asian descent and is~     also seen in individuals having Native American or Hispanic ancestry. Therefore genetic~     etiology has been hypothesized. This study, we aim to find the susceptibility genes that~     associate with TPP. Both candidate genes approach and genome wide association study have been~     conducted.~   "
237702|NCT00443820|"~     This study is designed to assess the efficacy, safety and tolerability of a topical~     formulation of terbinafine solution applied daily in patients with toenail fungus. This trial~     will study patients with mild to moderate toenail fungus disease of the big toenail and their~     responses to two treatment durations, 24 or 48 weeks.~   "
237703|NCT00443807|"~     A highly desired result in neuroanesthesia is a prompt, controlled emergence following a~     neurosurgical procedure. Considerable strides have been made in this direction with volatile~     anesthetic agents such as sevoflurane or desflurane administered in association with the~     narcotic remifentanil. It is characteristic that patients will emerge within 5 to 10 minutes~     of cessation of these agents at the end of a neuroanesthetic. However, there are cases where~     emergence is delayed, especially after periods of deep anesthesia for i) cerebral protection~     with temporary clipping of cerebral aneurysms and ii) with microvascular decompression for~     trigeminal neuralgia. Deep levels of anesthesia are standard for these procedures in the~     posterior fossa, which utilize motor evoked potentials to assess cranial nerve function. In~     these cases, EEG monitoring is standard. Using the EEG to monitor emergence to aid its~     progress makes sense. A monitor which could predict emergence in these patients would be~     valuable. EEG monitoring engineered to provide this information is now available in the form~     of the EEGo. This study is designed to test the hypothesis that the EEGo monitor will be~     superior to the BIS monitor to assess emergence following neuroanesthesia.~   "
237720|NCT00443586|"~     This study will evaluate the long-term effects of a prenatal and early childhood home nurse~     visitation program for socially disadvantaged women and their children.~   "
237828|NCT00019578|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I~     trial to study the effectiveness of stereotactic radiosurgery in treating patients who have~     brain tumors.~   "
237704|NCT00443794|"~     STUDY TITLE A randomized double-blind controlled trial of the efficacy and safety of the~     POLYCAP® versus its components in subjects aged 45 to 80 years of age with at least one~     additional cardiovascular risk factor.~      STUDY OBJECTIVES This study is designed to assess the efficacy and safety of the POLYCAP®, a~     fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering~     agents, a beta blocker, an ACE inhibitor, a diuretic and a statin.~      STUDY DESIGN~      Randomized controlled double-blind trial of the POLYCAP® versus its components in eight~     formulations.~      STUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD~     risk factor.~      INVESTIGATIONAL PRODUCTS Composition POLYCAP® and its comparators FOLLOW UP The total~     duration of follow up will be 4 months, from the start of study medication.. Subjects will~     take study medication for 3 months. There will be a final follow up visit 1 month after~     stopping the study medication.~      There will be five follow up visits, the first 7 - 10 days after starting study medication~     and thereafter monthly visits for 4 months. Subjects taking any of the study medications~     prior to enrolment will have one or more additional visits during a defined wash out and~     before enrolment.~      OUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of~     the three month period.~      STATISTICAL ISSUES Non-inferiority evaluation of the POLYCAP in modifying BP, lipids and~     platelet activity [as measured by urinary thromboxane] when compared with its different~     components in eight different formulations.~   "
237705|NCT00443781|"~     The primary objective of this study is to document and compare diagnostic test results and~     procedure safety in subjects undergoing both Functional Anaesthetic DiscographyTM (F.A.D.)~     and provocative discography (PD) and determine the appropriateness of the F.A.D. procedure~     data collection script for use in a larger clinical trial.~   "
237706|NCT00443768|"~     To identify patients within the community taking anti-parkinson medications in whom the~     diagnosis of Parkinson's disease is incorrect and to supervise and clinically monitor the~     withdrawal of anti-parkinson medications in this patient group~   "
237707|NCT00443755|"~     The objective of this study is to determine whether targeted pharmacological improvement of~     insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory~     cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.~   "
237708|NCT00443742|"~     The objective of the study is to improve general practitioners' diagnoses of adolescent~     depression. Major depression is ranked fourth in the worldwide disability impact. The~     proportion of adolescents suffering from depressive disorders also seems to be increasing~     worldwide. Early interventions are known to reduce this illness. Therefore, the earlier~     depression can be identified in adolescents, the greater the advantage.~   "
237709|NCT00443729|"~     The purpose of this study is to investigate the efficacy, safety, and tolerability of an~     investigational treatment for patients with Human Immunodeficiency Virus (HIV).~   "
237710|NCT00443716|"~     To evaluate the effect of estrogen treatment on adipocytic and osteoblastic parameters by~     histomorphometrically measuring adipocyte volume (AV/TV) and adipocyte numbers in goldner's~     stained iliac crest bone biopsy specimens collected from subjects recruited in the study (IRB~     number 21B85). The adipocytic parameters will be then correlated with osteoblastic parameters~     obtained previously during the course of the initai study involving the effect of transdermal~     estrogen on bone turnover in postmenopausal osteoporotic women.~   "
237711|NCT00443703|"~     The purpose of this study is to investigate the efficacy, safety, and tolerability of an~     investigational treatment for patients with HIV.~   "
237712|NCT00443690|"~     To evaluate the effect of KW-3902IV, in addition to standard therapy, on the proportion of~     worsening heart failure and worsening renal function, and on the proportion of deaths or~     rehospitalizations for heart failure or worsening renal function, and to estimate and compare~     within-trial medical resource utilization and direct medical costs between subjects treated~     with KW 3902IV versus placebo.~   "
237713|NCT00443677|"~     The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD~     regimens.~   "
237714|NCT00443664|"~     To prove that external contact micropulse diode laser trabeculoplasty (EMDLT) can~     significantly lower intraocular pressure in cases of advanced open angle glaucoma.~   "
237715|NCT00443651|"~     This is a Phase III, open-label study of a total of approximately 560 subjects with active~     rheumatoid arthritis (RA) who have had an inadequate response to one or more~     disease-modifying anti-rheumatic drugs (DMARDs). Enrollment in the study was conducted in two~     stages. In Stage I of the study, approximately 400 subjects receiving non-biological DMARDs~     (with the exception of methotrexate [MTX] monotherapy or MTX and leflunomide combination~     therapy) were enrolled. In Stage II of the study, approximately 160 subjects receiving a~     Federal Drug Administration-approved biological DMARD at the time of screening were enrolled.~   "
237716|NCT00443638|"~     The Elmira follow-up study is designed to assess the extent to which prenatal and infancy~     home visitation by nurses affects the life-course development of 19-year-old youth whose~     mothers received those services during pregnancy and the first two years of the child's life.~   "
237717|NCT00443625|"~     This study was designed to investigate the food effect of SK3530 on the pharmacokinetics~     (PKs).~   "
237718|NCT00443612|"~     Primary:~        1. To compare the change in forearm vascular resistance following a 12-week regimen of~          irbesartan/hydrochlorothiazide versus irbesartan~        2. To assess changes of serum proinflammatory cytokine, markers of cardiovascular risks,~          oxidative stress and circulating adhesion molecule including thiobarbiturate acid~          reactive substances (TBARS), C-reactive protein (CRP), interleukin 6 (IL-6), and~          vascular cell adhesion molecule 1 (VCAM-1).~      Secondary:~        1. To compare the reduction in office blood pressure following a 12-week regimen of~          irbesartan/hydrochlorothiazide versus irbesartan~        2. To compare the response rate (defined as office Systolic blood pressure(SBP)/diastolic~          blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate~          (defined as SBP<140 mmHg and /or DBP<90 mmHg)~        3. To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus~          irbesartan when administered once daily~        4. To determine whether angiotensin II type 1 (AT-1) receptor gene polymorphisms (including~          A1166C gene with about 4% of the minor allele frequency in Chinese population and other~          single nucleotide polymorphisms with a higher frequency of about 10% of minor allele) is~          related to reduction of BP~   "
237722|NCT00443560|"~     The objective of this study will be to compare epidural infusion management, specifically~     looking at infusion rate changes, in patients who receive forceps deliveries versus normal~     spontaneous vaginal deliveries. We will match patients based on time and date of delivery, as~     well as parity, in order to eliminate these variables as potential con-founders.~      We hypothesize patients who require a decrease in their basal labor analgesia epidural~     infusion rate will have an increased incidence of forceps delivery.~   "
237723|NCT00443547|"~     The purpose of this study is to measure the benefits of anterior (from the front) cervical~     (neck) surgery for degenerative disc disease. The research part of this study is the~     answering of questionnaires by the patient concerning their quality of life, prior to, and~     after surgery.~   "
237724|NCT00443534|"~     This protocol allows subjects who have participated in a previous SU011248 protocol the~     ability to continue to receive SU011248 after their study has ended.~   "
237725|NCT00443521|"~     The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide~     after laser panretinal photocoagulation in the treatment of proliferative diabetic~     retinopathy.~   "
237726|NCT00443508|"~     This study is design to compare two different strategies aiming to lessen the degree of the~     ongoing process of allograft injury either by removing tacrolimus from the maintenance~     immunosuppressive protocol or by reducing tacrolimus dose.~      The primary goal is to assess the change in renal function at 6 and 12 months after~     conversion using creatinine levels and calculated creatinine clearance.~      The study will include two groups: The study group of 30 patients and a matched control group~     with creatinine levels at similar range.~   "
237727|NCT00443495|"~     Chitin microparticles (CMP) has been demonstrated in animal studies that have modelled~     allergic rhinitis to be effective against a wide range of common respiratory allergens. It is~     an immuneenhancer.~      The primary purpose of the study is to demonstrate safety in a first into man study on 24~     human volunteers. The secondary objective is to demonstrate efficacy by chosing subjects that~     demonstrate a response to a nasal allergen challenge using grass pollen.~      The subjects are being given increasing doses of CMP, supplied as a nasal spray, for 7 days~     followed by a nasal allergen challenge with Timothy Grass Pollen extract. Over this period~     nasal symptom scores, eosinophil counts and cytokine measurements will be performed.~   "
237728|NCT00443482|"~     This study is designed to demonstrate that formoterol 12µg and 24µg delivered by a new~     inhalation device (Concept1) are equivalent to the corresponding dose of formoterol delivered~     by the Aerolizer device in terms of efficacy, in patients with persistent asthma.~   "
237729|NCT00443469|"~     It involves delivering a train of magnetic pulses, 5 at each time, to the brain. In the~     present study, we are using the same method to treat severe pain due to nerve conditions. You~     will be given up to 1000 pulses in total over the spine in the lower back (Spinal Magnetic~     Stimulation or SMS). Each train will be given in 10-second intervals. You will have SMS on a~     single day. You will be given SMS pulses at 1 or 10 per second. No stimulation will be given~     over the head.~      You will be assessed before and after the study for up to 1 week. Your usual medical~     treatment will be continued~   "
237730|NCT00443456|"~     To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects~     who will be able to enter a long-term study after completing the parent study A double-blind~     comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension~     for whom amlodipine 5 mg is insufficiently effective (Protocol No.: A0531085).~   "
237731|NCT00443443|"~     This is an observational study designed to follow patients with RA who have had an inadequate~     response to one or more anti-TNF therapies and who will receive Rituxan. Approximately 1000~     patients in the United States with RA who have had an inadequate response to anti-TNF~     therapies and who will receive Rituxan therapy will be recruited. There is no protocol~     mandated treatment assignment in this study. Patients will be evaluated and treated according~     to their physician's standard practice and discretion.~   "
237732|NCT00443430|"~     The purpose of this study is to compare two aggressive drug regimens for children with~     poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA.~   "
237733|NCT00443417|"~     The purpose of this study is to find optimistic dose and to evaluate the efficacy and safety~     of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.~   "
237734|NCT00443404|"~     Severe pre-amputation pain is associated with phantom pain development, and phantom pain~     models assign major importance to central and peripheral nervous system changes related to~     pre-amputation pain. Several interventions have been evaluated for phantom pain prevention,~     including continuous brachial plexus blockade5, intravenous6 or epidural ketamine~     administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9,~     but their true effect remains unclear.~   "
237735|NCT00443391|"~     The objective of this study is to evaluate the long-term safety and tolerability of ABT-089~     in adults with ADHD.~   "
237736|NCT00443378|"~     This study evaluates an interactive computer counseling tool to help HIV-positive individuals~     develop an integrated health promotion plan incorporating antiretroviral (ART) adherence and~     HIV transmission risk reduction. We hypothesize that evidence-based counseling for ART~     adherence support and for HIV transmission risk reduction can be delivered effectively in a~     self-administered computer tool.~   "
237737|NCT00443365|"~     The purpose of this study is to assess whether adding mitral valve repair to coronary artery~     bypass grafting improves outcome in patients with ischemic mitral regurgitation.~   "
237738|NCT00443352|"~     This is a single-center, open-label, pilot trial to collect and evaluate data on the safety~     and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic~     migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered~     into an 84-day treatment period. Subjects will be titrated over the first four weeks to a~     dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on~     individual subject response and/or subject's tolerability. Subjects will maintain a daily~     diary capturing detailed information on migraine headache days.~   "
237739|NCT00443339|"~     This is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS~     patients with an International Prognostic Scoring System (IPSS) score of low or intermediate~     1.~   "
251101|NCT00265265|"~     The purpose of this study is to assess potential interactions between intravenous (i.v.)~     cocaine and atomoxetine (Strattera) administered orally in four escalating doses.~   "
237740|NCT00020475|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining~     vaccine therapy with interleukin-2 may be a more effective treatment for metastatic melanoma~     of the eye.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy and interleukin-2 in~     treating patients who have metastatic melanoma of the eye.~   "
237741|NCT00020371|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have~     cancers that have not responded to previous therapy.~   "
237742|NCT00020345|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving the drugs in different ways, such as directly into the~     abdomen, and combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation~     therapy plus surgery in treating patients who have advanced cancer of the pancreas.~   "
237743|NCT00020267|"~     RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill~     tumor cells.~      PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating~     patients who have metastatic cancer that has not responded to previous therapy.~   "
237744|NCT00019643|"~     RATIONALE: Chemotherapy may affect various factors that can lead to weight gain.~      PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving~     adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer.~   "
237745|NCT00443326|"~     Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis~     to study safety, pharmacokinetics, and efficacy. Dose levels include 150mg and 300mg and will~     be given to each subject for a total of 6 doses. Each dose for each subject will be given~     once every 2 weeks. Subjects will followed for up to 300 days post the first dose of AMG 714.~   "
237746|NCT00443313|"~     Background:~        -  Cancer of the cervix (bottom third of the uterus, or womb) can be prevented by regular~          Pap tests (also called Pap smears), which check for changes in the cells of the cervix.~          Because many women in the United States have regular Pap smears, cervical cancer is not~          common in this country. However, the disease is common among women in the Mississippi~          Delta because of poor participation in screening programs.~        -  The major causes of cervical cancer are persistent human papillomaviruses (HPV)~          infection by cancer-associated HPV types and lack of screening. These viruses cause an~          infection that often goes away by itself, but if it does not go away, over a long time~          lead to cervical cancer. HPV causes cervical abnormalities, which are detected by Pap~          smears and then treated.~      Objectives:~      -To determine whether an at-home self-collection method for obtaining cells from the cervix~     can be a simple, safe and inexpensive way to screen for cervical cancer for women who don t~     go to the health clinic regularly.~      Eligibility:~        -  Women who reside in the counties of Leflore, Sunflower, Washington or Tallahatchie,~          Mississippi.~        -  Women between 26 and 65 years of age who are not pregnant and who have not had a~          hysterectomy.~      Design:~      Screening study participants undergo the following:~        -  The doctor takes a cervical sample using the same self-collection device that women will~          use at home to self-collect.~        -  Pelvic examination and Pap test. For this test, the woman lies on an exam table and the~          doctor inserts an instrument called a speculum into the vagina, opening it to see the~          cervix. A special brush is used to take a few cells from the cervix. The cells are~          placed on a glass slide and sent to a lab for examination.~        -  Cervical cell specimen collection using an at-home self-collection kit that participants~          will use at home after 2 weeks~        -  At-home self-collection by participant after 2 weeks.~        -  Referral to a doctor for follow-up care, if needed.~        -  Colposcopy (see below) in all women with a Pap test that is abnormal or positive for HPV~          and for some women with a normal smear.~      Colposcopy study participants undergo the following:~        -  The doctor takes a cervical sample using the same self-collection device that women will~          use at home to self-collect.~        -  Colposcopy, an exam in which the doctor examines the cervix using a light and looks~          through a magnifying device to see if there is any abnormal tissue on the cervix. During~          this exam, the doctor may remove a small sample of tissue to diagnose any abnormality.~          Participants also have a sample collected using the self-collection kit.~        -  At-home cervical sample collection by participant after 2 weeks.~        -  Notification if further medical care is required and treatment if the biopsy looks~          abnormal.~   "
237747|NCT00443300|"~     The goal of this clinical research study is to learn if the protected environment (PE) can~     help to prevent infections in patients aged 60 and above who are receiving what is considered~     low-intensity treatment for newly-diagnosed AML or high-risk MDS.~   "
237748|NCT00443287|"~     The primary objective is to investigate in patients suffering from intermittent claudication~     due to Fontaine stage II Peripheral Arterial Disease (PAD) whether a 26-week treatment by~     HMR1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing~     three doses of HMR1766 to placebo, and calibrating such effect versus cilostazol.~   "
237749|NCT00443274|"~     Ten year safety study examining rates of rare adverse events, child bearing issues, effects~     of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast~     implants.~   "
237750|NCT00443261|"~     To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin~     combination in patients with squamous cell carcinoma of head and neck (SCCHN).~   "
237751|NCT00443248|"~     The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical~     system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a~     control unit. Output data are collected on a PC. By measuring the clearance of heat from the~     heated probe, a direct measure of absolute blood flow can be obtained. The study will assess~     the technique's ability to differentiate between pre- and post-menopausal women; with and~     without Female Sexual Arousal Disorder (FSAD).~   "
237752|NCT00443235|"~     The primary objective is to analyze and compare the efficacy, the response rate, the CR and~     the response rate duration of both induction treatments and both maintenance treatments~   "
237753|NCT00443222|"~     This is a 4 month open trial with TNF-blockade using infliximab (an antibody that blocks TNF)~     in adult patients with chronic myositis (polymyositis, dermatomyositis, inclusion body~     myositis) who have persisting muscle weakness and inflammatory active disease despite~     adequate treatment with immunosuppressives either currently or previously.~      Infliximab is given as infusions, 5 mg/kg body weight, these infusions are repeated after 2,~     6 and 14 weeks. The study involves 15 adult patients.~      Primary outcome measure is muscle function assessed by muscle function index score.~      Other outcome measures are Myositis Disease Activity core set: Patient’s global assessment~     and physicians global assessment on visual analogue scales (VAS). Manual muscle test, Health~     assessment questionnaire (HAQ), serum levels of CPK, LD and extra muscular disease activity~     score. Muscle biopsy, Magnetic resonance imaging (MRI) of thigh muscles and Health related~     Quality of life, measured by SF-36.~   "
237754|NCT00443209|"~     The purpose of this study is to investigate the safety and tolerability of telcagepant~     (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary~     hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of~     acute migraine in adult participants.~   "
237882|NCT00441727|"~     The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily~     versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous~     low-dose acetylsalicylic acid.~   "
237755|NCT00443196|"~     2.0 Study Objectives: 2.1 To evaluate the ability of the MiCK assay to predict the outcome of~     chemotherapy of cancer patients for first-line treatment.~      2.2 To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients in a~     third-line, refractory treatment setting (exclusive of anti-VEGF)~   "
237756|NCT00443183|"~     Patients with hazardous and harmful alcohol consumption are at increased risk for adverse~     health consequences and have frequent visits to the Emergency Department(ED). Despite~     research that has demonstrated the prevalence of alcohol problems in ED patients, there are~     limited data on the effectiveness of brief intervention (BI) strategies for patients in this~     setting. The purpose of the current study is to evaluate the effectiveness of a brief~     intervention, termed Brief Negotiation Interview (BNI), provided by emergency practitioners~     (EPs-emergency physicians and physician assistants), in reducing alcohol consumption in ED~     patients with hazardous and harmful drinking. In a controlled randomized clinical trial of~     500 patients with hazardous and harmful drinking, BNI will be compared to scripted discharge~     instructions (DI). Three hypotheses will be tested: BNI is superior to DI in: 1) reducing~     alcohol consumption; 2) reducing the number of binge drinking episodes; and 3) increasing~     utilization of primary care or alcohol-related services. Alcohol consumption and utilization~     of primary care or alcohol-related services will be measured by self-report at 1,6 and 12~     months. An additional benefit to changing patterns of consumption and utilization of health~     services may be decreased ED visits and alcohol-related hospitalizations. These will be~     assessed utilizing a statewide database. In order to facilitate real-world application of BNI~     in the ED, the project will result in a BNI manual for EPs and an adherence and competence~     scale. Unique features of the current project as compared to earlier studies include: 1)use~     of a credible control condition; 2) enrollment of a heterogeneous population; 3)use of a~     manual-guided intervention by existing ED staff; 4)systematic assessment of adherence and~     competence to ensure quality administration and discriminability of interventions;~     5)monitoring of use of ancillary treatments; and 6)monitoring of repeat ED visits and~     alcohol-related hospitalizations.~   "
237757|NCT00443170|"~     This is a first time in human study to investigate the safety of GSK626616AC given as oral~     single and repeat doses in healthy subjects. An additional group of subjects will be assessed~     to determine the effect of several drugs given at the same time as GSK626616.~   "
237758|NCT00443157|"~     This study is the third in a series using the MenB vaccine from the National Institute of~     Public Health in Norway (NIPH). The vaccine was first made in response to a high incidence of~     disease using the 44/76 strain which was resopnsible for most of the disease there. The VEC~     did the first study, MNB1, using this vaccine. Since then the NIPH has formed a commercial~     partnership with Chiron Vaccines and has reformulated the vaccine using the NZ98/254 MenB~     strain for use in New Zealand.~      The vaccine was first produced at NIPH facilties and it was this vaccine that was used in our~     second study, MNB2. The current study, MNB3, will use the NZ98/254 MenB vaccine but from~     Chiron facilities where production has been scaled up in order to provide enough doses for~     the national immunisation campaign that is ongoing in New Zealand.~   "
237759|NCT00443144|"~     The protein polymorphism of the growth hormone receptor characterized by the genomic deletion~     of exon 3 has been linked to the magnitude of the first-year-growth response to growth~     hormone (GH) in girls with Turner syndrome.~      Objective: to study the long-term effect of GH therapy in Turner syndrome in correlation to~     this GHR polymorphism in a mainly retrospective design (chart-review).~   "
237760|NCT00443131|"~     In this study, two experimental malaria vaccines (with adjuvants) are tested to evaluate and~     characterise how the vaccine exactly works on the immune system by comparing it to a control~     (without adjuvant). The Protocol Posting has been updated in order to comply with the FDA~     Amendment Act, Sep 2007.~   "
237761|NCT00443118|"~     A multicenter cross-over cluster randomized controlled trial protocol study in newborn~     infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure~     ventilation [PPV]) for resuscitation in the delivery room comparing a T-piece resuscitator~     device versus resuscitation bag.~   "
237762|NCT00443105|"~     The purpose of this study is to determine the efficacy, tolerance and safety of tacrolimus~     0.03% ointment in the treatment of intractable allergic conjunctivitis.~   "
237763|NCT00443092|"~     The primary purpose of this research study is to test the ability of a proprietary cherry~     juice blend to be helpful in the treatment of osteoarthritis (OA) of the knee.~   "
237764|NCT00443079|"~     The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from~     milk thistle, to determine whether it is safe and well-tolerated in adults who have~     non-alcoholic steatohepatitis (NASH). An additional aim of this study is to determine whether~     Siliphos may be beneficial in treatment of NASH as indicated by improvement in liver enzymes~     (ALT and AST). The study hypothesis is that Siliphos will be safe and well-tolerated in~     people with NASH and will result in a decrease in the liver enzymes ALT and AST.~   "
237765|NCT00443066|"~     Spinal Muscular Atrophy (SMA) is the leading genetic cause of death in infancy. It is a~     devastating disease that leads to progressive loss of those nerve cells that control our~     muscle bulk and movement. Patients develop increasing weakness in all muscles, eventually~     including those needed for breathing. In more than half of patients, SMA starts in infancy~     and typically leads to death within the first 2 years of life. In others, the disease begins~     in childhood and leads to significant disability.~      SMA is caused by a defect in the Survival of Motor Neurons (SMN1) gene. Researchers are~     hopeful to find a cure, because nature has provided humans with a second gene, almost an~     identical copy of the SMN1 gene. Normally, the second gene does not contribute much, but~     researchers think that its function can be increased by medications.~      To find out whether these medications help patients with SMA, we have to conduct clinical~     trials. Here, we propose to prepare for clinical trials. We will invite SMA patients to join~     our research effort. We will examine them regularly to better understand their disease. The~     visits will include questions, physical exam, blood drawing, and sometimes X-rays and a skin~     biopsy. We will use modern computer methods to process the information. While we are doing~     this, we will plan a clinical trial. Once the clinical trial begins, we will offer SMA~     patients participation if they meet the criteria for that trial.~      We will make sure that the participants' privacy is maintained and that the study risks are~     as low as possible.~      Identifying an effective SMA treatment is very important because there is currently none.~     Clinical trials are the only way to decide whether a new treatment works in SMA patients or~     not.~   "
237766|NCT00443053|"~     To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of~     acute (recent) superficial thrombophlebitis.~   "
237767|NCT00443040|"~     The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients~     who have undergone a laparoscopic segmental colectomy and determine whether it reduces the~     time to recovery of bowel function compared to placebo.~   "
237956|NCT00440765|"~     The main purpose of this study is to evaluate safety and effectiveness of the treatment of~     multiple myeloma with bortezomib in daily practice in the Netherlands.~   "
237768|NCT00443027|"~     The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical~     system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a~     control unit. Output data is collected on a PC. By measuring the clearance of heat from the~     heated probe, a direct measure of absolute blood flow can be obtained. The study will assess~     changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.~   "
237769|NCT00443014|"~     The Dementia Study in Northern Norway is an open controled intervention trial carried out in~     nine rural municipalities, five of which allocated to intervention and four to control. A RCT~     with donepezil and placebo is superimposed on all patients included in the study. In this way~     the study has a 2x2 factorial design. The outcome measures are changes in cognitive~     performance and ADL function measured by standardized cognitive and neuropsychological tests~     every four months during a one-year follow-up.~      The main goal of this study is to examine the effect of systematically and individually~     adjusted stimulation therapy on cognitive function in patients having recent diagnoses of~     Alzheimer´s disease (AD).~      A secondary goal is to examine whether or not ChEI has an additional effect on cognitive~     function superimposed on stimulation therapy.~      From January 2006 to 31th March 2008 187 patients with a recent diagnosis of dementia were~     included. Patients were recruited by GPs in routine practice (n=87) and by a population based~     screening (n=100).Screening recruited younger patients with a higher MMSE-score, and~     relatively more men. All over, women were older and at a more serious disease stage. After~     age adjusting significantly more women were living single and required more supports from the~     community nursery.~   "
237770|NCT00443001|"~     This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in~     subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of~     the ANSI/AAMI SP10 Standard.~   "
237771|NCT00442988|"~     A statistical analysis of the predictive value of OGTT and FPG testing executed as part of~     standard clinical practice after renal transplantation for the diagosis of new-onset diabetes~     mellitus after transplantation.~   "
237772|NCT00442975|"~     The study is being undertaken to evaluate responses to seasonal influenza vaccine in older~     adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that~     infects many people, but does not usually cause disease in the individual unless they are~     immunocompromised i.e. their immune system is not working well such as in the case of HIV~     infection. CMV is believed to have infected up to 80% of individuals in the age group we will~     be looking at in our study and we are interested in whether this infection affects their~     responses to vaccination.~   "
237773|NCT00442962|"~     The purpose of this study is to determine if pregnancy-limited, short-term combination HIV~     treatment regimens -- which were used solely for the prevention of mother to child~     transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard~     initial regimen of anti-HIV drugs when subsequent treatment is needed.~   "
237774|NCT00442949|"~     Release of troponin evaluated by the peak of troponin during the hospital phase.Because of~     its sensitivity and specificity as well as its widespread use in routine practice, rise in~     troponin levels is the main assessment criteria of this study. We plan to demonstrate a~     significantly altered distribution of the troponin release as evaluated by the peak of~     troponin for each patient during the hospitalization period (from randomization to~     cardiologic unit discharge), in the two arms of the trial.~   "
237775|NCT00442936|"~     The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974)~     compared to an approved medication for acute migraine. This study was conducted as a~     triple-dummy design; for each dose of study drug, participants each received 3 forms of~     study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and~     were instructed to take one of each form of study drug at dosing time.~      The primary hypotheses of this study are that telcagepant is superior to placebo in Pain~     Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2~     Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours~     Post-Dose.~   "
237776|NCT00442923|"~     The purpose of this research study is to determine whether Carvedilol, an FDA approved beta~     blocker, when administered for an 8-week period to veterans currently undergoing treatment~     for methamphetamine dependence (1) improves their ability to stay in treatment longer,~     (2)eases the aversive symptoms that accompany stimulant withdrawal, and (3) increases the~     time they remain abstinent from methamphetamine.~   "
237777|NCT00442910|"~     There is an urgent need for HIV prevention methods that women can initiate and control~     themselves. Topical microbicides, substances that kill microbes, represent one such method.~     The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w~     SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days~     in healthy, sexually active HIV uninfected women.~   "
237778|NCT00442897|"~     Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving~     ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment~     panel (ATP) III guidelines~   "
237779|NCT00442884|"~     The study is designed to evaluate the effects of acute psychological stress on blood glucose~     levels. We will study one group of patients in the fasting state on a control day and a~     stress test day, another group will undergo the same protocol in the postprandial state.~   "
237780|NCT00442871|"~     The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down~     in the body by healthy subjects versus subjects with mild, moderate or severe kidney~     problems. The study is also being done to 1) check on how well the study drug is tolerated by~     healthy subjects versus those with liver problems and 2) to check if liver impairment affects~     how the study drug binds to protein in the blood.~   "
237781|NCT00442858|"~     The aim of the present study was therefore two-fold: 1) to make a retrospective comparison of~     incidence of non-fatal stroke and cardiac events between a large cohort of patients with~     confirmed GHD on replacement therapy (including GH) and a control cohort from the general~     population; 2) to compare the prevalence of DM and cardioprotective medication between the~     cohorts at the time of questionnaire distribution with adjustment for possible confounders~     and effect modifiers.~   "
238008|NCT00440089|"~     This randomized controlled trial examines the efficacy of hands-on-healing for fatigue and~     immune function in breast cancer survivors. Participants may be randomized to one of three~     groups: hands-on-healing, touch alone, or a control group.~   "
237782|NCT00020202|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have~     refractory or progressive small cell lung cancer or non-small cell lung cancer.~   "
237783|NCT00020046|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping~     blood flow to the tumor.~      PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel with or without~     thalidomide in treating patients who have metastatic prostate cancer.~   "
237784|NCT00019968|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Infusing melphalan directly to the tumor may kill more tumor cells~     and cause less damage to healthy tissues. It is not yet known whether melphalan plus tumor~     necrosis factor is more effective than melphalan alone for soft tissue sarcoma.~      PURPOSE: Randomized phase II trial to study the effectiveness of isolated limb perfusion of~     melphalan with or without tumor necrosis factor in treating patients who have soft tissue~     sarcoma of the arm or leg.~   "
237785|NCT00019890|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating~     patients who have high-risk stage III or completely resected metastatic melanoma.~   "
237786|NCT00019760|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving them in different ways may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of melphalan given as an isolated hepatic~     perfusion followed by chemotherapy infused into the liver in patients who have unresectable~     colorectal cancer that is metastatic to the liver.~   "
237787|NCT00019695|"~     RATIONALE: Ketoconazole may suppress the production of hormones and may interfere in the~     growth of prostate cancer cells. Alendronate sodium may be effective in preventing bone~     metastases and bone pain associated with prostate cancer. It is not known if ketoconazole is~     more effective with or without alendronate sodium.~      PURPOSE: Randomized phase II trial to study the effectiveness of ketoconazole with or without~     alendronate sodium in treating patients who have metastatic prostate cancer.~   "
237788|NCT00019630|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of liposomal doxorubicin in treating~     children who have refractory solid tumors.~   "
237789|NCT00019448|"~     RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor~     cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.~     Combining vaccine therapy and interleukin-2 may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy with or without~     interleukin-2 in treating patients with metastatic melanoma that has not responded to~     previous treatment.~   "
237790|NCT00019396|"~     RATIONALE: The drug flt3L may stimulate a person's immune system and help to kill tumor~     cells. Vaccines made from melanoma cells may make the body build an immune response to and~     kill their tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of flt3L with or without vaccine therapy~     in treating patients with metastatic melanoma or renal cell cancer.~   "
237791|NCT00019188|"~     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by~     stimulating a person's white blood cells to kill their tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of interleukin-12 in treating patients~     with AIDS -related Kaposi's sarcoma.~   "
237792|NCT00019097|"~     RATIONALE: Vaccines made from a person's tumor cells may make the body build an immune~     response and kill their tumor cells. Peripheral stem cell transplantation may be able to~     replace immune cells that were destroyed by chemotherapy used to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation~     plus vaccine therapy and chemotherapy in treating patients who have multiple myeloma.~   "
237793|NCT00003552|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may allow doctors to give~     higher doses of chemotherapy and kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus peripheral stem~     cell transplantation in treating patients with metastatic melanoma.~   "
237794|NCT00442845|"~     Physicians tend to always use the lowest dose of statins to initiate therapy even in subjects~     who require large reductions in cholesterol. The study evaluates if selecting the starting~     dose based on baseline and target LDL-C cholesterol would provide better results (ie~     proportion of subjects resching target)~   "
237795|NCT00442832|"~     The purpose of this study is to determine whether TD-1792 is safe and effective when used to~     treat complicated skin and skin structure infections caused by Gram-positive bacteria.~   "
237796|NCT00442819|"~     Background: Uremic pruritus is one of the common complications in long-term dialysis~     patients. In general, many factors including xerosis, elevated serum calcium, phosphate,~     calcium-phosphate product, hyperparathyroidism and inadequate dialysis may contribute to it.~     Recently, researchers reported that immuno-hypothesis with high serum level of cytokines~     could be the cause of uremic pruritus. Polymethylmethacrylate (PMMA) artificial kidney (AK)~     has been reported to adsorb more serum cytokines than other high flux artificial kidneys.~      Methods: In July 2006, 30 patients with severe uremic pruritus from 300 chronic hemodialysis~     patients in a single center entered this prospective study. Their dialyzers were changed to~     PMMA AK for 4 weeks. The severity of pruritus was evaluated every week using the results of a~     questionnaire (pruritus score). Laboratory assays including pre-dialysis serum blood urea~     nitrogen, creatinine, β2-microgblubulin (β2M), calcium, phosphate, intact parathyroid hormone~     (iPTH), total CO2, ferritin, hematocrit, high sensitivity C-reactive protein (hsCRP), IL-1,~     IL-2, IL-6, IL-18, TNF-α, KT/V and β2M clearance were measured before and at the end of 4~     weeks of PMMA AK use.~      Expected Results:To prove the PMMA membrane could improve the uremic pruritus and to reveal~     the effect of PMMA membrane on serum level of possible factors contributing to uremic~     pruritus.~   "
237797|NCT00442806|"~     The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived~     Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute~     myocardial infarction.~   "
237798|NCT00442793|"~     This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta,~     in patients with chronic renal anemia who are on dialysis. Eligible patients will be~     randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta~     (3 times weekly, according to approved labelling). The anticipated time on study treatment is~     3-12 months, and the target sample size is 100-500 individuals.~   "
237799|NCT00442780|"~     The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is~     tolerated when given at different doses to patients with early-stage Parkinson's Disease.~      This study will also explore:~        -  How BIIB014 is affected when given to patients with early-stage Parkinson's Disease~          (this will be done by measuring the levels of BIIB014 in the blood at several different~          times during the study), and~        -  The activity of BIIB014 when given to early Parkinson's patients (this will be done by~          performing different Parkinson's Disease assessments and other tests during the study).~      Patients who enter this study will be randomly assigned to receive either BIIB014 or a~     placebo but because the study is blinded, neither they nor their study doctor will know which~     study treatment they are taking.~   "
237800|NCT00442767|"~     The primary objective of this study is to examine the effect of pramlintide given pre-meal~     and insulin given just after a meal has been taken vs. standard therapy of pre-meal insulin~     on post-prandial glucose excursions.~      The secondary objective is to examine the effect of pramlintide and insulin on glucagon~     suppression in type 1 diabetes.~   "
237801|NCT00442754|"~     Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate~     (MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of~     patients with advanced or metastatic non-small cell lung cancer (NSCLC). Adjuvant Aldara~     cream will be used as adjuvant for induction of inflammation at the injection site, and the~     lymphocyte growth factor of interleukin-2 (IL-2) will be given as s.c. injection. The~     treatment aims at boosting the patient's specific immune system against the cancer cells.~   "
237802|NCT00442741|"~     The purpose of this extension study is to evaluate the potential inhibitory effects of~     patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.~   "
237803|NCT00442728|"~     The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on~     intensive care was studied. The aim of this study was to explore if electrical stimulation~     could prevent muscle atrophy.~   "
237804|NCT00442715|"~     Vigorous exercise is known to cause transient bronchoconstriction in school children with~     asthma, many of whom initially have normal lung function at rest. The presence and extent of~     this phenomena in early childhood is difficult to recognize, because exercise induced~     bronchoconstriction (EIB) may not limit the child's performance and the child may fail to~     notice the symptoms until taking part in organized or competitive sport. Conversely, as~     children do participate in vigorous activities all day long, severe EIB may provoke a crucial~     disabling condition in the child.~      In school children the exercise challenge test (ECT) is a well standardized test and is used~     to make a diagnosis of asthma because it is able to discriminate between asthma and other~     chronic breathing illnesses of childhood and is also used to determine the effectiveness and~     optimal dosages of medications prescribed to prevent EIB.~      The test includes is a controlled run on a motor-driven treadmill followed by scheduled~     multiple spirometry maneuvers. This procedure was never been tested and may not be suitable~     for the preschool age.~      In this study we assumed that a free-run test which combined with measurements of duplicate~     spirometry-sets would be the most convenient way to test young children.~      The aims of this study are a) to examine the feasibility of a free-run protocol (according to~     the ATS/ERS recomendations), followed by duplicate spirometry measurements in early~     childhood.~      b) to explore the existence of exercise induced bronchoconstriction in young children (age~     3-6 years old) with respiratory symptoms.~   "
237805|NCT00442702|"~     This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the~     treatment of anemia in patients with chronic kidney disease who are not on dialysis and who~     are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized~     either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly~     subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the~     weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
237806|NCT00442689|"~     The purpose of this study is to investigate the metabolic effects of anti-androgens and oral~     contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We~     hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs~     would produce improvement in metabolic markers in PCOS women and would reduce their long term~     metabolic risk.~   "
237807|NCT00442676|"~     Preeclampsia is a hypertensive disorder of pregnancy and a leading cause of fetal and~     maternal morbidity and mortality. Recent findings indicate preeclampsia is an inflammatory~     disorder associated with increased expression of COX-2. This study will test the hypothesis~     that treatment of women with a COX-2 inhibitor, celecoxib, will stop the inflammatory process~     and reverse symptoms of preeclampsia.~   "
237808|NCT00442663|"~     The purpose of this study is to compare the efficacy of a transcervical Foley catheter with~     and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.~   "
237809|NCT00442650|"~     Multicentre, open label, phase III study. Subjects with moderate to severe psoriasis were~     given efalizumab subcutaneously once per week for the 12-week treatment period. Assessments~     involved physical examination, disease activity assessments, clinical laboratory tests~     (haematology, blood chemistry and standard urinalysis), evaluation of the Psoriasis Area and~     Severity Index (PASI), the Physician's Global Assessment (PGA), the Patient's Global~     Psoriasis Assessment (PGPA), the SF-36 Health Survey and psoriatic body surface area (BSA).~     The 12-week treatment period was followed by a 12-week follow-up (FU) period, during which~     other antipsoriatic medications were allowed. The same assessments were also performed in the~     12-week FU period.~   "
237829|NCT00019006|"~     RATIONALE: Vaccines made from mutated ras peptides may make the body build an immune response~     to and kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of a vaccine containing mutated ras~     peptides and an immune adjuvant in treating patients who have colon, pancreatic, or lung~     cancer.~   "
237810|NCT00442637|"~     The optimal duration of systemic treatment in patients with advanced colorectal cancer is~     unknown.~      In this study the effects of bevacizumab and low-dose continuous chemotherapy with~     capecitabine is investigated in patients who have responded to 6 courses of oxaliplatin,~     capecitabine and bevacizumab (induction treatment, at standard doses). This treatment is~     continued until progression or severe toxicity. This regimen is compared to the effects a~     observation without treatment after the induction treatment.~      In case of disease progression, induction treatment will be reintroduced.~   "
237811|NCT00442624|"~     We aim to assess the influence of chronic insomnia on the neuroendocrine regulation of the~     glucose and lipid metabolism to more clearly define the metabolic derangements associated~     with chronic insomnia and to prove that chronic insomnia is associated with increased levels~     of stress hormones, cytokines and impaired insulin sensitivity.~   "
237812|NCT00442611|"~     Systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the~     skin and other internal organs for which there are few effective treatment options. We~     hypothesize that treatment with abatacept, a new therapy recently approved for the treatment~     of rheumatoid arthritis, may reduce the progression of skin thickening and fibrosis in people~     with scleroderma.~   "
237813|NCT00442598|"~     Primary Objectives:~        -  To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects~          with ovarian cancer~        -  To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as~          compared with every 21-day dosing~      Secondary objectives:~        -  To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by~          objective response rate, duration of response, progression-free survival, and overall~          survival~        -  To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and~          after treatment~      Exploratory objective:~        -  To correlate efficacy endpoints with expression of tumor-associated glucose transporter~          proteins~   "
237814|NCT00442585|"~     The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet~     inhibition under steady state acetylsalicylic acid conditions.~   "
237815|NCT00442572|"~     This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS~     in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and~     biochemical response after treatment with interferon alfa. After 48 weeks therapy with~     interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized~     into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4~     therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly~     for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational~     arm will receive no specific antiviral treatment. The anticipated time on study treatment is~     1-2 years, and the target sample size is 100 individuals.~   "
237816|NCT00442559|"~     The purpose of this study is to assess real-world effectiveness of montelukast in children (2~     to 14 years) with asthma and allergic rhinitis.~   "
237817|NCT00442546|"~     Pregabalin added to the standard of care with dosing starting preoperatively and continuing~     for up to 6 weeks post surgery will decrease the intensity of post-operative pain following~     total knee replacement.~   "
237818|NCT00442533|"~     The purpose of this study is to determine if High-dose 111In-Pentetreotide known as~     NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.~   "
237819|NCT00442520|"~     The purpose of this study is to look at several genes that might determine how the body~     processes the drugs used to treat lung, colorectal and head and neck cancers. The goal of~     this examination is to help investigators determine the proper dosage to give future cancer~     patients or to better predict which future patients will respond to particular drug~     therapies.~   "
237820|NCT00442507|"~     Determine the time to progression for the combination of erlotinib and bevacizumab in~     patients with previously treated metastatic cancer of the esophagus or gastroesophageal~     junction~   "
237821|NCT00442494|"~     Atrial fibrillation is the most common arrhythmia to occur after cardiac surgery.~     Inflammatory response may be one etiological factor.~      We hypothesized that intravenous corticosteroid administration after cardiac surgery prevents~     AF after cardiac surgery.~   "
237822|NCT00442481|"~     The purpose of this study is to assess the effect of escitalopram on sleep architecture~     utilizing a prospective design.~      Hypothesis: Escitalopram will improve REM latency in patients with MDD that have responded~     clinically to treatment.~   "
237823|NCT00442468|"~     The study does not involve testing of a drug (no treatment intervention). The study will will~     use spirometry (breathing tests) in subjects of 40 years of age and older with a history of~     cigarette smoking with chronic bronchitis to check their disease status and whether or not~     they have COPD. Also, study subjects will be asked to complete a questionnaire (to answer a~     list of questions on paper).~   "
237824|NCT00442455|"~     The purpose of the study is to determinate the free-progression interval in patients with~     surgically resected locally advanced squamous cell carcinoma of head and neck treated with~     the maximum tolerated dose of the combination of erlotinib, radiation therapy and cisplatin,~     previously established in a safety trial.~   "
237825|NCT00442442|"~     Although mosquito coils are widely used, there is no robust evidence that their use can~     provide clinical reduction in malaria. This study will randomise 4 groups of 400 houses, each~     with 5 people, in rural China and monitor cases of malaria in each group each month for 6~     months. The treatment groups will include Coils, Treated bed nets, Coils plus treated bed~     nets, or no treatment (control). All cases detected will be given prompt appropriate~     treatment.~   "
237826|NCT00442429|"~     Morbidity and Mortality among Dialysis Patients after Treating Depression~      Objectives~      Our investigation has two objectives:~        1. To assess whether treatment and recovery from depression decreases adverse clinical~          events in chronic hemodialysis patients. Significant morbidity is associated with~          depression in dialysis patients, but subsequent impact on outcome after treatment of~          depression has not been reported.~        2. To examine the rates of recovery from depression over a 6-month and 12-month period~          among prevalent dialysis patients. Rates of recovery among dialysis patients with~          depression are unclear. The natural history of depression among dialysis patients may~          help long-term management.~      Plan and Methods~      This project is a longitudinal prospective cohort study comprised of dialysis patients from~     outpatient dialysis units in the Portland, Oregon metropolitan area. Patients must be aged 18~     or older and have started dialysis at least 90 days prior to enrollment. Patients are~     excluded if they are delirious, demented, cannot speak English, or have a prior psychiatric~     diagnosis other than depression. Baseline data collection includes patient demographics,~     etiology of renal disease, nutritional status, past medical and psychiatric history and~     baseline health status. Social support and quality of life assessments are obtained from~     direct interview. All patients are assessed for depression by the Beck Depression Index, a~     depression scale particularly useful in those with chronic illness, and the Diagnostic~     Interview Scale, a gold standard for depression assessment.~      Those that are depressed will undergo pharmacologic treatment with an SSRI, if they agree,~     and be reassessed at 2 and 6 months for improvement. Patients who do not respond are referred~     for psychiatric therapy. The primary outcome of our study is the combined rate of~     prespecified morbidity and mortality at 18 months between two groups: depressed subjects~     agreeing to treatment and depressed subjects not agreeing to treatment. Prespecified~     morbidities include rates of 1) cardiovascular and cerebrovascular events, 2) infections, 3)~     vascular access complications, and 4) death. These were selected based on prior studies~     suggesting that depression increases cardiovascular and cerebrovascular events, suppresses~     the immune system, and up-regulates coagulation factors and platelet aggregation. , , , , , ,~      Chi-square tests and T-tests will be used to compare baseline variables among those who are~     and are not depressed. A multivariable Cox proportional hazards model will compare survival~     among groups, with adjustments for baseline variables. Calculations derived from the~     Neyman-Pearson equation determined a sample size of 120 subjects.~      Findings to date~      We have enrolled 134 subjects to date, including 47 from the PVAMC, and 87 from outside~     dialysis units. Twenty-percent of them have been depressed. (We need to enroll 120 depressed~     patients.) No further results have been obtained this year. No further characteristics have~     been analyzed to date. All adverse events have been reported, none were unexpected.~      Significance~      We hope to demonstrate a reduction in adverse clinical outcomes with treatment of depression.~     If so, we would advocate that depression is a modifiable risk factor that warrants therapy~     for well-being in dialysis patients.~   "
237827|NCT00442416|"~     This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal~     dialysis patients who self-inject at home or receive in-centre injections. The safety of~     subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be~     assessed. Eligible patients will be randomized either to receive monthly sc injections of~     Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms,~     or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to~     reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is~     3-12 months, and the target sample size is 380 individuals.~   "
237834|NCT00442351|"~     This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study~     evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with~     Asmanex Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced~     expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or~     end of the study).~   "
237835|NCT00442338|"~     The study estimates the efficacy and safety of MK0476 and aminophylline intravenous~     administration in adult participants with acute asthma.~   "
237836|NCT00442325|"~     European physicians tend to always use the lowest dose of statins to initiate therapy even in~     subjects who require large reductions in cholesterol. The study evaluates if selecting the~     starting dose based on baseline and target LDL-C cholesterol would provide better results (ie~     proportion of subjects resching target)~   "
237837|NCT00442312|"~     This study is to evaluate the efficacy and safety of Combigan ophthalmic solution in~     combination with Latanoprost when the therapy is swiched from Latanoprost monotherapy in~     patient with Glaucoma or ocular hypertension.~      Hypothesis:~        1. Combigan Ophthalmic Solution provides addition IOP loweringwhen combined with~          Latanoprost.~        2. The treatment with Combigan Ophthalmic Solution has an acceptable safety profile, as~          measured by ocular and systemic safety parameters.~   "
237838|NCT00442299|"~     The uremic syndrome is mainly related to the retention of a host of compounds, due to altered~     glomerular filtration and other factors of renal dysfunction, e.g. tubular secretion. Uremic~     retention solutes are arbitrarily subdivided in three different categories according to their~     physicochemical characteristics and their subsequent behaviour during dialysis: (i) the~     small, water-soluble, non-protein bound compounds, (ii) the larger middle molecules, mainly~     peptides and (iii) the small protein-bound compounds (1).~      Although direct proof is lacking, several lines of evidence indicate that albumin is the most~     important carrier protein. Removal of protein bound uremic retention solutes is limited.~      The Prometheus® system fractionates blood into plasma and cellular components, using an~     albumin-permeable polysulfon filter (AlbuFlow®) with a specially designed sieving coefficient~     curve (1.0 for 2-microglobulin, >0.6 for albumin, <0.3 for IgG, <0.1 for fibrinogen and~     <0.01 for IgM). Due to the high sieving coefficient of the filter for large molecules (i.e.~     cut-off at about 250 kD) molecules up to the size of albumin (69 kD) easily pass from blood~     into the secondary circuit which is filled with isotonic sodium chloride solution, whereas~     larger molecules like fibrinogen (340 kD) cannot pass through the filter. In the secondary~     circuit the filtered plasma with the albumin-bound toxins flows through one or two adsorbers~     in a row with maximized adsorption capacity for putative liver toxins that are directly~     adsorbed (`fractionated plasma separation and adsorption' or FPSA). The purified plasma is~     then returned to the blood side of the albumin filter. In order to eliminate water-soluble~     toxins, blood thereafter undergoes hemodialysis using a conventional high-flux dialyser.~      We hypothesise that removal of protein bound uremic retention solutes can be improved by FPSA~     as compared to standard hemodialysis.~   "
237839|NCT00442286|"~     The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos~     system in subjects with hypertension that are resistant to treatment with at least three~     anti-hypertension agents, one of which is a diuretic.~   "
237840|NCT00442273|"~     To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops~     in the treatment of severe dry eye syndrome.~   "
237841|NCT00442260|"~     Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in~     Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) [Phase I~     and II]~   "
237842|NCT00442247|"~     Anterior vaginal wall prolapse is a common problem. Until now many different surgical~     techniques have been evaluated but so far recurrence is often still observed. Therefore,~     synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.~   "
237843|NCT00442234|"~     To investigate PK and coagulating and fibrinolytic parameter profiles (PD) at the approved~     dose (13,750 - 27,500 IU/kg) in patients with acute pulmonary embolism accompanying~     hemodynamic instability.~   "
237844|NCT00442221|"~     The objective of this study is to assess the safety of a single-tablet dose of Combo~     Formulation for the treatment of moderate to severe migraines~   "
237845|NCT00442208|"~     Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH~     (percent time pH> 4.0) following twice daily administration at different dosing times~     relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.~   "
237846|NCT00442195|"~     The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of~     laboratory research experiments that require blood and tissue samples from healthy~     volunteers. This protocol provides a mechanism for collecting these tissue samples. Research~     includes studies of normal and abnormal formation of blood cells, viral blood diseases, the~     role of the immune system in marrow failure and genetic risk factors for aplastic anemia.~      Healthy normal volunteers 8 years of age and older may be eligible for this study. Samples~     are collected as follows:~        -  Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of~          blood, which is obtained from a needle placed in an arm vein.~        -  Participants 8 years of age and older donate a buccal mucosa sample (cells from the~          inside of the cheek). The inside of the cheek is scraped gently with a nylon brush.~        -  Participants 18 years of age and older donate a bone marrow sample. The bone marrow is~          obtained from the hip bone. The skin over the area is wiped clean with alcohol and~          iodine, and then a local anesthetic is injected under the skin and also into the bone.~          When the area is numb, a bone marrow aspiration needle is introduced through the bone~          surface into the marrow. The marrow cells are collected using a syringe connected to the~          needle.~   "
237847|NCT00442182|"~     Autoinflammatory syndromes (AIS) are a group of disorders characterized by recurrent episodes~     of inflammation.Although for the hereditary autoinflammatory diseases the genetic mutations~     are known it remains largely unclear how these mutations lead to recurrent inflammatory~     attacks. Treatment of the inflammatory symptoms remains a challenge. With beneficial~     responses reported during treatment with simvastatin, etanercept or anakinra in some but not~     all patients. ITF2357 is an orally active histon deacetylase inhibitor with a potent~     anti-inflammatory effect due to inhibition of pro-inflammatory cytokines (IL-1β, TNFα, IFNg,~     IL-6). We expect that ITF2357 is able to modify the clinical symptoms of AIS patients and~     induce clinical complete remission or a reduction in attack duration.~   "
237848|NCT00442169|"~     The purpose of this study is to determine whether a single subcutaneous injection of~     ChimeriVax-WN02 vaccine is well tolerated, safe and induces protective antibodies against~     West Nile Disease. The study is divided into two parts; in the first part, a comparison of 3~     dose levels of the vaccine will be made, with an inactive control. In the second part, the~     optimum dose level chosen after the first part will be given to older volunteers.~   "
237849|NCT00442156|"~     The study objective is to determine the course of changes in OCT measured macular thickness~     and visual acuity following a single session of focal photocoagulation for center-involved~     DME. The response will be evaluated separately in eyes with and without prior focal~     photocoagulation for DME. The purpose is to determine the proportion of eyes that continue to~     improve at least 5 letters in visual acuity or at least 10% in central retinal thickness~     after a session of focal photocoagulation. In addition, the study will explore whether any~     baseline factors can be identified that are predictive of the response.~      All subjects will have follow-up visits 8 weeks and 16 weeks post treatment. At the 16-week~     visit, study eyes are evaluated for change in retinal thickness and visual acuity from~     baseline.~        -  Treatment is to be deferred and follow up continued if visual acuity letter score has~          improved by >5 or OCT central subfield thickness has decreased by >10% compared with~          baseline.~        -  If visual acuity letter score has not improved by at least 5 and OCT central subfield~          thickness has not decreased by at least 10%, then the eye is classified as 'not~          improved' and the investigator may provide additional treatment. Follow up ends for eyes~          that receive additional treatment at this visit. However, if the investigator and~          participant elect to defer additional treatment (even if deferral criteria are not met),~          then follow up will continue until the study eye receives additional treatment for DME.~        -  Eyes continuing in follow up have visits every 8 weeks (+1week) as long as there has~          been continued improvement in visual acuity (letter score improved >5 ) or retinal~          thickness (central subfield thickness decreased by >10%) compared with the visit 16~          weeks earlier. The longest follow-up time will be 48 weeks.~      By providing information on the length of time during which clinically meaningful improvement~     occurs following focal photocoagulation, clinicians will be better able to determine when~     further photocoagulation or other treatments should be considered for persistent DME.~     Depending on the results of this study, a future randomized clinical trial will be considered~     comparing the more aggressive retreatment photocoagulation regimen currently serving as the~     standard DRCR Network approach to focal photocoagulation for macular edema with the less~     aggressive regimen evaluated in this protocol.~   "
237850|NCT00442143|"~     The aim of the study is to investigate whether implantation of autologous bone marrow derived~     stem cells in ishemics limbs will improve vascularization~   "
237851|NCT00442130|"~     The purpose of this research study is to assess the safety and immune activity of a vaccine~     made from the participant's own cancer cells, when administered after a reduced intensity~     transplant. In recent years, researchers at Dana-Farber Cancer Institute have discovered that~     vaccines made from a patients's own cancer cells, that have been engineered in the laboratory~     to produce a protein called GM-CSF, can be effective in stimulating a powerful immune~     response specific to that cancer.~   "
237852|NCT00442117|"~     This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder~     Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder~     Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated~     with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate~     persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks.~     The primary efficacy endpoint is percent change from baseline in FEV1.~   "
237853|NCT00442104|"~     To allow open-label extension to patients who have completed Protocol 1042-0500~   "
237854|NCT00442091|"~     Dandelion juice has been used in herbal medicine for at least 1000 years. Vesicular hand~     eczema is a rare, but difficult to treat, type of hand eczema. One case report has shown that~     ingestion of dandelion juice could induce a beneficial effect on this type of eczema. The~     purpose of this study is to test whether this effect can be retrieved in other patients.~   "
237855|NCT00442078|"~     The main objective is to evaluate the clinical efficacy on continence, quality of life and~     tolerance of the sub-urethral tape I-STOP on male patient suffering of incontinence~     significant and embarrassing after a radical prostatectomy.~   "
237856|NCT00442065|"~     To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal~     Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the~     neck of the aneurysm or in the common iliac arteries.~   "
237857|NCT00442052|"~     Primary: To compare the gastroprotective effects of a once-daily dose of PA 325 combination~     tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a~     once-daily dose of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy~     findings in normal healthy volunteers.~   "
237858|NCT00442039|"~     This clinical trial is being performed under the Best Pharmaceuticals for Children Act,~     signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The~     purpose of this study is to examine the efficacy and safety of lithium in the treatment of~     pediatric patients with bipolar I disorder.~   "
237859|NCT00442026|"~     This trial will compare the efficacy of the docetaxel and gemcitabine combination versus~     monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC~   "
237860|NCT00442013|"~     Many individuals with asthma also experience gastroesophageal reflux disease (GERD), a~     condition in which excess stomach acid flows backwards into the esophagus. This study will~     evaluate the effectiveness of lansoprazole, a medication commonly used to treat GERD in~     improving asthma control and reducing symptoms in children with poorly controlled asthma.~   "
237861|NCT00442000|"~     Compare peri-operative and postoperative outcomes of the three different surgical approaches~     to prostatectomy~   "
237862|NCT00441987|"~     The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single~     oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese~     subjects.~   "
237863|NCT00441974|"~     This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the~     efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB.~     Primary endpoint is proportion of subjects achieving HBV DNA undetectable (<=1000 copies/mL~     by by Roche COBAS AMPLICOR HBV MONITOR Test) at week 48. Approximately 1250 patients will be~     recruited in 30 study centers in China. The subjects are offered 48 weeks of open label~     adefovir dipivoxil treatment, with assessments every three months, after with is a 12-week~     post study treatment follow-up prior to study completion.~   "
237864|NCT00441961|"~     Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.~   "
237865|NCT00441948|"~     The purpose of this study is to determine whether a new laser system provides better safety~     and efficacy in hair removal than existing lasers.~   "
237866|NCT00441935|"~     The study is to collect information from patient charts and patient questionnaires to~     evaluate the effects of nerve stimulation therapy on urinary dysfunction.~   "
237867|NCT00441922|"~     This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment~     in elderly patients with advanced NSCLC.~   "
237868|NCT00441909|"~     Vaginal microbicides are compounds that may protect women from HIV and other sexually~     transmitted infections (STIs). This study will determine the safety of the microbicide UC-781~     by comparing the effects of keeping the microbicide in the vagina for different lengths of~     time.~   "
251102|NCT00265252|"~     To determine the cumulative incidence of total hip replacement, time to event after treatment~     with Fosamax or placebo during the study peroid~   "
237869|NCT00441896|"~     The study is a two period (8-10 days/period), incomplete cross-over in which successive~     cohorts of 9 subjects are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each~     cohort, Sequence A, comprised of 6 subjects, receives ascending doses of ganaxolone during~     period 1 and ganaxolone (at the maximal dose attained in period 1) and ascending doses of~     placebo during period 2. Sequence B, comprised of 3 subjects, receives ascending doses of~     placebo during period 1 and receives the maximum dose of placebo and ascending doses of~     ganaxolone during period 2. The dosing level in each subsequent cohort will be based upon~     experience gained from previous cohorts.~   "
237870|NCT00441883|"~     This study will evaluate the safety and efficacy of PF 03187207.~   "
237871|NCT00441870|"~     This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses~     of EC0225 in patients with refractory or metastatic tumors who have exhausted standard~     therapeutic options.~   "
237872|NCT00441857|"~     This study aims to measure the effect of three different doses of plant stanols in margarine~     on the cholesterol absorption efficiency in subjects with mildly to moderately increased~     serum LDL cholesterol concentrations~   "
237873|NCT00441844|"~     Type I diabetes (T1DM) is associated with an increased risk of vascular complications. While~     the precise mechanism(s) by which diabetes accelerates atherosclerosis has not been~     elucidated, several lines of evidence point to the role of increased inflammation in the~     pathogenesis of these vasculopathies. The monocyte-macrophage is a pivotal cell in~     atherogenesis and is readily accessible for study. However, there is scanty data on monocyte~     function and inflammation in T1DM. Simvastatin, a HMG-CoA reductase inhibitor, has recently~     been shown to reduce cardiovascular events in diabetic patients (T1DM and T2DM in the Heart~     Protection Study). Recent studies demonstrate that simvastatin decreased C-reactive protein~     and decreased pro-atherogenic activity of monocytes in non-diabetic subjects. However, there~     is a paucity of data on the effect of simvastatin on inflammation and monocyte function in~     Type 1 diabetes.~      Thus, the purpose of this study is Aim 1) to assess biomarkers of inflammation in T1DM~     compared to matched controls (n=50/group). Aim 2) Also, we will assess the effect of~     simvastatin (20mg/day) therapy on inflammation and monocyte function in T1DM in a randomized,~     placebo-controlled, double blind trial.~   "
237874|NCT00441831|"~     Helicobacter pylori (HP) is a gram-negative bacillus responsible for one of the most common~     infections found in humans worldwide. By the early-to-mid 1990s, further evidence emerged~     supporting the link between the chronic gastritis of HP infection and malignancy in adults,~     specifically gastric lymphoma and adenocarcinoma. The potential of HP eradication for the~     prevention of gastric cancer was underlined. At the national consensus meeting held in~     Brussels in 1998, HP eradication was strongly recommended in past or current peptic ulcer~     diseases, regardless of activity, complication and post endoscopic resection of early cancer.~     Some patients received gastric surgery due to the complications of peptic ulcer such as~     bleeding or perforation in the pre-HP eradication era. Their HP infection status was not~     surveyed and unknown at the time. Afterward, some of them were not suggested to receive an~     eradication therapy and recovered from the operative procedure. According to the consensus to~     treat HP for a purpose to reduce the risk of gastric cancer, these patients were still under~     risk. There have been only a few surveys on the prevalence of persistent HP infection in~     patients who have undergone surgery. The aim of the study was to evaluate the prevalence and~     histological features of HP infection after a time course of partial distal gastric surgery.~   "
237875|NCT00441818|"~     The purpose of this study is to determine the safety and effectiveness of TNX-650 for~     Injection when administered to patients with refractory Hodgkin's lymphoma.~   "
237876|NCT00441805|"~     Radiofrequency emmitting device, normaly used for thermage treatments will be used on 22 mild~     to moderate acne patients faces.~      The aim of the study is to check whether RF heating of subcutaneous and dermis will improve~     acne in needed patients.~   "
237877|NCT00441792|"~     The primary aim is to determine the difference in hospital length of stay between septic~     patients given etomidate and those given midazolam for induction during rapid sequence~     intubation (RSI) in the emergency department. To achieve this aim we plan to perform a~     prospective randomized trial measuring the length of stay of patients meeting sepsis criteria~     and requiring intubation. The investigators will compare in-hospital mortality rates between~     patients given etomidate and patients given midazolam for induction. In addition to hospital~     length of stay, secondary endpoints between the two groups will include length of stay in the~     intensive care unit, death within 48 hours of admission, and total number of days intubated.~      Research Hypothesis:~      In adult patients presenting to the emergency department with sepsis and requiring rapid~     sequence intubation, the length of stay of patients given etomidate will be greater than that~     of patients given the alternative agent midazolam for induction.~   "
237878|NCT00441779|"~     Blood transfusions are frequently necessary in situations in which there is a large amount of~     blood loss. In some individuals who receive a blood transfusion, white blood cells from the~     donor's blood may remain in the body for years, a condition known as microchimerism. This~     study will evaluate the occurrence of microchimerism among the following three groups of~     individuals who previously received transfusions: 1) individuals with traumatic injuries; 2)~     individuals with burn injuries; and 3) individuals who underwent elective orthopedic~     operations.~   "
237879|NCT00441766|"~     This study will explore the safety and effectiveness of different doses of AGN 203818 in~     relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A~     enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment~     duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or~     placebo over 12 week treatment duration.~   "
237880|NCT00441753|"~     Survivors of a cardiac arrest frequently develop severe postanoxic encephalopathy.~     Derangements in cerebral blood after return of spontaneous circulation play an important role~     in the pathogenesis of postanoxic encephalopathy. In the present study we examine the effect~     of mild therapeutic hypothermia on cerebral blood flow and carbondioxide reactivity in~     patients after cardiac arrest.~   "
237881|NCT00441740|"~     The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination~     versus the gemcitabine/docetaxel combination as first line treatment, offers a survival~     advantage in patients with locally advanced/metastatic NSCLC.~   "
237883|NCT00441714|"~     To adjust our forearm model for ischemia reperfusion injury, in order to used it for~     assessment of ischemia reperfusion damage in elderly and patients.~      To test the effect of ischemic postconditioning on ischemia reperfusion injury in healthy~     volunteers, using Annexin binding after repetitive handgripping.~   "
237884|NCT00441701|"~     This is a two-part study conducted at multiple centers, of navarixin (SCH 527123, MK-7123) in~     participants with moderate to severe chronic obstructive pulmonary disease (COPD). Part 1 of~     the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of~     four treatment groups enrolled in three cohorts. The duration of treatment, for each cohort,~     will be a 2-week run-in period, followed by a 12-week double-blind treatment period.~     Treatment initiation for each cohort was staggered by 4 weeks to allow for safety assessment~     prior to use of higher doses of navarixin. Part 2 of the study will be a double-blind,~     placebo-controlled, randomized, parallel group study consisting of four treatment groups~     enrolled as one cohort. The duration of treatment will consist of a 2-week run-in period,~     followed by a 12-week double-blind treatment period.~   "
237885|NCT00441688|"~     This study is a cross sectional observational study to evaluate the prevalence of HLA-B*5701~     in the major French ethnotypes.~      Any HIV-1 infected subject will be eligible for this study including antiretroviral therapy~     (ART) naÃ-ve and experienced subjects irrespective of abacavir use, as well as subjects~     previously tested for HLA-B*5701. Subjects will be approached during a standard clinic visit,~     and all subjects will be consented prior to any study specific procedure. Subjects will be~     asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess~     HLA-B*5701 status by central and local methodologies.~   "
237886|NCT00441675|"~     The CATO population is a very well documented population during two years. During this study~     patients were treated according to the CATO algorithm, after that patient were treated~     according to the Dutch national (GINA derived) guidelines up to 6 years of follow-up. The~     purpose of this prospective follow-up study is to understand the long-term effects of~     treatment. Therefore the measurements done at baseline (CATO part 1) are repeated after 6~     years in this CATO-population (CATO follow-up).~   "
237887|NCT00441662|"~     Melanoma is the most common primary tumour which occurs inside the eye. For over 20-years, it~     has been possible, in many cases, to use local delivery of radiation to the eye to treat this~     type of tumour, avoiding the need to surgically remove the affected eye. This treatment,~     however, is often complicated by radiation-induced loss of vision, months or years after~     treatment.~      The aim of this research project is to investigate the potential prevention of radiation~     complications in the eye by giving anti-inflammatory medication (a long-acting steroid) in~     the form of a local injection around the eye at the time of treatment, and at 4-months and~     8-months following treatment. This medication (named ‘triamcinolone’) has been successfully~     used to treat similar complications of diabetic eye disease, for example, and has a good~     safety profile.~      The rationale of this study is to attempt to preserve vision, in addition to preserving the~     eye, in patients affected by this eye tumour, and therefore preserve quality of life for~     these patients.~   "
237888|NCT00441649|"~     This study will evaluate the safety and effectiveness of methylphenidate in treating~     attention deficit hyperactivity disorder in children with both attention deficit~     hyperactivity disorder and Tourette syndrome.~   "
237889|NCT00441636|"~     The purpose of the study is to determine the effect on mood and anxiety symptoms of adding~     CPAP to the psychiatric treatment of patients with TRD (treatment resistant depression) and~     associated OSA (obstructive sleep apnea).~   "
237890|NCT00441623|"~     Study on the natural history of uremic retention solutes in patients with mild-to-moderate~     chronic kidney disease~   "
237891|NCT00441610|"~     CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in~     Japanese patients.~   "
237892|NCT00441597|"~     To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after~     ischemic exercise in the non-dominant forearm.~   "
237893|NCT00441584|"~     This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate~     the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The~     study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who~     did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve~     sustained virological response (SVR) when treated with PegIntron plus Rebetol.~   "
237894|NCT00441571|"~     The proposed phase 1 clinical trial will investigate the safety and tolerability of~     177Lu-CYT-500 in patients with metastatic prostate cancer and determine the optimal antibody~     mass and dose of 177Lu to be used for further study.~   "
237895|NCT00441558|"~     To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness~     of Flibanserin in Women with HSDD that have already completed a previous study~     (511.70/71/.74/.75/.105) with Flibanserin.~   "
237896|NCT00441545|"~     To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the~     reduction of serum phosphorus levels from baseline.~   "
237897|NCT00441532|"~     Patients at risk for having prostate cancer usually undergo a biopsy of their prostate. This~     is most often done in the private urology office. Recent studies have suggested that~     injection of local anesthesia (lidocaine) near the nerves of the prostate will improve pain~     sensation during the biopsy procedure. Local anesthesia can be given through a separate~     needle through the rectal probe just prior to biopsy. However, many urologists to date~     perform their biopsies without anesthesia. Some claim that the needle used for anesthesia~     causes pain itself. Others claim that the pain is so minimal that the additional use of~     lidocaine (and extra time) is not necessary. We plan to reexamine the use of lidocaine and~     perform the first study where each patient will receive lidocaine and placebo on separate~     sides of their prostate.~   "
237898|NCT00441519|"~     To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet~   "
237957|NCT00440752|"~     The newly introduced antimalarial drug artemether-lumefantrine is currently recommended as~     second line antimalarial in Sudan. Recurrent infection after treatment with this drug has~     been associated with selection of certain genes in the malaria parasite. However there is no~     information on this association in Sudan.This study is going to look into the genetics of~     resistance to artemether-lumefantrine.~   "
237899|NCT00441506|"~     Critically ill children are often sedated in order to relieve them from anxiety and~     discomfort, and to facilitate their care. There is little information on the effects of~     prolonged and continuous use of sedatives and analgesic agents in critically ill children. In~     adult intensive care unit (ICU) patients, daily interruption of sedative infusions~     accelerates recovery resulting in a reduction in the average duration of mechanical~     ventilation of 2.4 days as well as a reduction in average ICU length of stay of 3.5 days.~     These results were achieved without an increased rate of adverse events potentially linked to~     less sedation and associated with a reduction of common complications of critical illness and~     without negative psychological effects.~      It is unknown whether these results can be extrapolated to critically ill children. Moreover,~     the possible risk of complications associated with less sedation, such as accidental~     self-extubation, is probably higher in children. Also, the need for intermittent bolus~     administrations in children treated with intermittent sedation could nullify the reduction in~     the use of sedatives.~      It is unknown if daily interruption of sedatives is feasible in critically ill children. The~     researchers studied the effects of daily interruption of sedatives in critically ill children~     on the total amount of sedatives used and risks of complications.~   "
237900|NCT00441493|"~     This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.~   "
237901|NCT00441480|"~     The purpose of this study is to determine whether plant sterols esterified to fish oil fatty~     acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG~     concentrations in healthy hyperlipidemic subjects.~   "
237902|NCT00441467|"~     Primary Objective:~      1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as~     measured by objective response rate~      Secondary Objectives:~        1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma~          as measured by duration of response, progression-free survival and overall survival~        2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma~      Exploratory Objectives:~        1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects~          with advanced soft tissue sarcomas, as determined by FDG-PET~        2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter~          proteins~   "
237903|NCT00441454|"~     The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become~     a standard operation worldwide for the treatment of women with stress urinary incontinence.~     This tape is placed from the vagina behind the pubic bone and exits through the skin of the~     lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a~     similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a~     window of the pelvic bones (the so-called obturator foramen), by what is called a~     transobturator approach. It is passed through the skin of the thigh (as opposed to the lower~     abdomen). The reason for this modification was to avoid injuring the bladder and, possibly,~     provide a more physiologic restoration of the continence mechanism. However, it is unclear~     whether the lateral (so-called transobturator approach) is as good as or better than the~     initial approach behind the pubic bone.~      The purpose of the present study is to compare the standard (retropubic) and the newer~     (transobturator) approach for the placement of a tape for treating women with stress urinary~     incontinence.~   "
237904|NCT00441441|"~     This study is to assess the safety of an investigational drug in children 4 to 11 years of~     age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in~     the morning, and have lung function tests performed.~   "
237905|NCT00441428|"~     Detrusor underactivity (DUA) in men is responsible for LUTS in a significant minority, the~     symptoms being indistinguishable from those seen in BOO. The International Continence Society~     (ICS) defines DUA as 'a detrusor contraction of inadequate magnitude and/or duration to~     effect complete bladder emptying in the absence of urethral obstruction. Whilst a reduced~     maximum urinary flow rate (Qmax) is indicative of voiding dysfunction, flow studies cannot~     distinguish between DUA and BOO, which are the two principal causes of low flow rates. DUA is~     diagnosed from a pressure-flow study (PFS)and is characterized by a low-pressure, poorly~     sustained, or wave-like detrusor contraction with an associated poor flow rate.~      Overactive bladder (OAB) is the most common term currently used in clinical medicine to~     describe a complex of lower urinary tract symptoms (LUTS) with or without incontinence but~     most commonly consisting of urgency, frequency, nocturia, troublesome or incomplete~     emptying,and, occasionally, pain. With the exception of pain and incontinence, these symptoms~     are often found together; thus, the term LUTS has come to replace previous terms, such as~     urgency-frequency syndrome,urethral syndrome, and prostatism.~      Drug treatment is frequently used as the initial management approach for LUTS in older~     men.Among men who desire treatment, general practice prescribing data have shown that~     antimuscarinics are not often given to elderly men. There is theoretical concern that the~     inhibitory effect of antimuscarinics on detrusor contraction could aggravate voiding~     difficulties or cause urinary retention in patients with BOO. There are virtually no data~     evaluating the safety and efficacy of solifenacin treatment in men with DUA and OAB.~   "
237906|NCT00441415|"~     The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% /~     Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in~     Subjects with acne vulgaris after a 12-week treatment period.~   "
237907|NCT00441402|"~     This study investigates the role of energy balance and stress in the regulation of~     hypothalamic-pituitary-gonadal axis in adolescent girls across the fitness spectrum.~   "
237908|NCT00441389|"~     To assess the infectious etiology related to acute exacerbation of COPD in Hong Kong~   "
237909|NCT00441376|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of ThermoDox when~     used in combination with radiofrequency ablation (RFA) in the treatment of primary and~     metastatic tumors of the liver.~   "
237910|NCT00441363|"~     The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo~     when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in~     persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy~     alone.~   "
238009|NCT00440076|"~     This is a four-center open-label study designed to determine activity of Velcade in~     Myelodysplastic Syndrome (MDS) patients. A total of 28 subjects will be enrolled. The~     patients will be registered to GIMEMA Data Center before therapy starts and after inclusion~     criteria verification.~   "
237911|NCT00441350|"~     The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ~     40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic~     BP in hypertensive patients after 8 weeks of double-blind treatment.~      The study consisted of two sequential phases of 8 weeks duration each:~      During the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to~     evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate~     to severe hypertension.~      During the second phase, patients whose BP proved to be insufficiently controlled by the OM~     40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose~     BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be~     up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the~     up-titrated combination.~      The study was be conducted by qualified and experienced personnel with adherence to GCP,~     current guidelines on the design of studies in hypertension, the applicable regulatory~     requirements and the ethical principles based on the Declaration of Helsinki.~   "
237912|NCT00441337|"~     To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when~     administered to patients with advanced non-small cell lung cancer, colorectal cancer,~     malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer~   "
237913|NCT00441324|"~     In programmes of IVF, normal women undergo controlled ovarian stimulation using exogenous FSH~     injections to obtain multiple eggs. The process results in eggs of mixed quality with a broad~     range of developmental and implantation potential.~      The aim of the study was to determine whether, treatment with recombinant human LH prior to~     the FSH injections can improve outcome for women undergoing IVF. High grade embryos implant~     with a higher frequency and baby delivery rate than poor quality embryos. The mature oocyte~     is the most important determinant of embryo quality. Early follicles, containing immature~     eggs, have LH receptors in the theca cells that surround the follicle, and LH stimulates~     these cells to produce factors essential for normal follicular development.~      The intent of the study was to use recLH treatment prior to recFSH to treat a cohort of~     follicles, so that they can all mature together, thus increasing the proportion of high grade~     oocytes and their subsequent embryos~   "
237914|NCT00441311|"~     The aim is to assess the efficacy of an intervention, academic detailing, a brief, frequently~     repeated educational program, on increasing recommendations for colorectal cancer screening~     among primary care providers by comparison to a service-as-usual control. The study is a~     stratified randomized clinical trial of primary care physicians, stratified by distinct urban~     communities in the New York metropolitan area. The primary outcome is colorectal cancer~     screening recommendations measured via medical audit at 12-month followup after~     randomization.~   "
237915|NCT00441298|"~     This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1%~     Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900~     young women at risk of sexually transmitted HIV infection. Participants will be provided with~     a supply of single-use, pre-filled applicators according to their randomisation. While in the~     study, participants will be asked to apply a first dose of the assigned study gel within 12~     hours prior to coitus and insert a second dose as soon as possible within 12 hours after~     coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic~     treatment of sexually transmitted infections, if required.~   "
237916|NCT00441285|"~     The purpose of this study is to determine if combination drug therapy of praziquantel and~     albendazole is safe and effective to cure neurocysticercosis.~   "
237917|NCT00441272|"~     This study will determine whether pioglitazone (Actos, a drug approved to treat diabetes, can~     benefit HIV-infected people with fatty liver. Fatty changes of the liver (also known as~     steatosis) have been linked to diabetes and long-term liver damage in some patients.~     Pioglitazone has been shown to improve fatty liver in people without HIV; this study will see~     if it is beneficial for people with HIV as well.~      HIV-infected patients 18 years of age and older with increased fat in the liver may be~     eligible for this study. Screening includes a CT scan and liver biopsy (withdrawal of a small~     sample of liver tissue through a needle).~      Participants are randomly assigned to take either 45 mg of pioglitazone or placebo (sugar~     pill) by mouth once a day for 48 weeks. At the end of 48 weeks, all participants stop taking~     their medication and are followed for an additional 48 weeks to see what, if any benefits, of~     pioglitazone persist after treatment is stopped. In addition to taking the study medication,~     participants undergo the following procedures:~        -  Visits to the NIH Clinical Center over a period of approximately 2 years at day 0 and~          weeks 2, 8, 16, 24, 32, 40, 48, 52, 72, and 96. Most visits take about 1 hour and~          include blood drawing for various laboratory tests.~        -  Insulin clamp test at day 0 and weeks 24 and 48 to see how the body processes glucose.~          This test takes 4 to 6 hours and may include an overnight stay at the Clinical Center. A~          catheter (plastic tube) is placed in a vein in the arm to infuse insulin and another is~          placed in a vein on the back of the hand to draw blood samples. Blood sugar is checked~          frequently and glucose is given to keep blood sugar at normal values.~        -  Nutrition evaluations at day 0 and weeks 24 and 48. Subjects write down all the food~          they eat and drink for 4 days before the visit. They meet with a nutritionist to review~          the food record and to complete simple measurements of body fat and shape.~        -  CT scan of liver and abdomen at weeks 24, 48, 72 and 96.~        -  Liver biopsy at week 48.~   "
237918|NCT00441259|"~     This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in~     India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV)~     or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a~     treatment period and a 2 year follow-up period.~      Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of~     vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days~     after completing vaccination.~   "
237919|NCT00441246|"~     The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in~     providing symptom relief when administered as an adjunct to antibiotic therapy in patients~     with acute respiratory infection.~   "
237920|NCT00441233|"~     The primary purpose of this study is to investigate the clinical performance of a new~     silicone hydrogel contact lens over a period of 6 months of extended wear.~   "
237958|NCT00440739|"~     The purpose of this study is to determine whether etoricoxib, flavoxate, both are effective~     in the treatment postoperative pain after TURP.~      The research hypothesis:~      There is a difference in postoperative morphine consumption in the first 24 hours after~     transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and~     placebo.~   "
238042|NCT00439647|"~     This study will investigate if the drug zoledronic acid given once yearly is safe and has~     beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with~     osteoporosis.~   "
251294|NCT00262665|"~     The purpose of this study is to test a candidate drug, Org 24448,in a phase II clinical trial~     in adult patients with moderately treatment-resistant unipolar major depressive disorder.~   "
237921|NCT00441220|"~     Cyclophosphamide is widely used in the treatment of cancer and autoimmune diseases such as~     lupus nephritis. However, there is considerable variability in the response to~     cyclophosphamide treatment. Cyclophosphamide is a pro-drug that requires initial activation~     by CYP liver enzymes. Recent clinical studies have indicated a possible role of one CYP~     enzyme, CYP2C19 in this activation step. This enzyme has a genetic polymorphism (variants~     which lack functional activity) and people who have inherited these variants are poor~     metabolisers of certain drugs.~      The aim of this study is to determine whether response to therapy in a New Zealand population~     of lupus nephritis patients is determined by cyclophosphamide bioactivation (the metabolic~     phenotype) and CYP genotype.~      Currently there is no way of predicting a patient's response to cyclophosphamide. An~     understanding of the factors which contribute to the therapeutic failure in lupus nephritis~     is particularly important due to the high morbidity and mortality associated with this~     disease. There are other treatment options for lupus nephritis patients who fail to respond~     to cyclophosphamide. If successful, this study may help identify patients who are unlikely to~     respond to cyclophosphamide and thus should not be unnecessarily be exposed to the drug and~     may justify the use of newer, more costly immunosuppressive drugs such as mycophenolate~     mofetil and rituximab.~   "
237922|NCT00441207|"~     The primary purpose of this study is to evaluate the safety and tolerability of vitamin C~     (ascorbic acid) given by injection into the vein.~      The second and third purpose of conducting this study is to observe any evidence of tumor~     response to the vitamin C and compare the level of fatigue (weakness), pain control, ability~     to do things, and quality of life, before and after vitamin C is given.~   "
237923|NCT00441194|"~     To compare the Octopus 311 and the HFA 700 series~   "
237924|NCT00441181|"~     Prostaglandin analogues have not been used in the treatment of neovascular glaucoma because~     of suspicious lack of efficacy. This study aims at assessing the effect of travoprost on~     neovascular glaucoma.~   "
237925|NCT00441168|"~     The purpose of this research study is to test the safety and effectiveness of replacing~     vincristine with a drug called bortezomib (also known as Velcadeor PS341) in the standard~     therapy vincristine, doxorubicin (not limited to, but formerly referred to under the~     tradename Adriamycin) and dexamethasone (VAD) in patients with multiple myeloma. Multiple~     Myeloma is the second most common cancer of the blood. Bortezomib is the first approved~     cancer treatment in a new class of medicines called proteasome inhibitors. It disrupts the~     cell cycle of the cell, affecting numerous biologic pathways, including those related to~     growth and survival of cancer cells. The treatment will be used as second line treatment,~     which means either the disease has returned after a period of improvement (relapse) or the~     disease did not respond to the initial treatment (refractory). Patients will receive either~     bortezomib (PS341), doxorubicin (Adriamycin) and dexamethasone (PAD) or the VAD standard~     therapy.~   "
237926|NCT00441155|"~     To provide study drug to patients that benefit from treatment judged by the investigator - to~     obtain additional long-term safety and efficacy data of this combination regimen in GIST~   "
237927|NCT00441142|"~     Phase I:~      The purpose of this research study is to determine the safety of the combination treatment of~     ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas,~     temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment~     of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given~     safely when combined with temozolomide (Temodar) and radiation therapy.~      Phase II:~      The purpose of this research study is to determine the efficacy of the combination treatment~     of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas,~     temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment~     of glioblastomas.~      All subjects participating in this research study must NOT be taking a certain type of~     anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but~     are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and~     trileptal.~   "
237928|NCT00441129|"~     . PRIMARY ENDPOINT~      The primary endpoint will be the change from baseline (Visit 3) to 6 months (Visit 6) of~     centrally measured HbA1c~      SECONDARY ENDPOINTS~        1. Change from baseline in mean blood glucose value calculated from CGMS recordings.~        2. Change from baseline in occurrence of hyperglycemia above 190 mg/dl .~        3. Change from baseline in occurrence of hypoglycemia below 70 mg/dl 4. Change from~          baseline of insulin doses.~      5. Total daily use of insulin. 6. % of daily use of insulin as basal rate. 7. % of daily use~     of insulin as bolus. 8. Patient Satisfaction questionnaire. 9. Health economic questionnaire.~     10. Quality of life questionnaire~   "
237929|NCT00441116|"~     The aim of this Phase III study is to compare the efficacy, safety and tolerability of~     dutasteride (0.5mg) with placebo for 6 months, in Korean male subjects with androgenetic~     alopecia in the vertex region, types IIIv, IV and V according to the modified~     Norwood-Hamilton Classification.~   "
237930|NCT00441103|"~     General Note: throughout this record, Rebif® New Formulation is used for historical and~     consistency purposes.~      Objectives:~      Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a~     [IFN-beta-1a], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple~     Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16~     weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of~     combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo~     treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to~     placebo.~      Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI~     lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).~      Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active~     MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16~     versus Weeks 17 - 40 for the subjects randomized to Group 2.~   "
237931|NCT00441090|"~     The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501~     (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic~     Idiopathic Thrombocytopenic Purpura (ITP).~   "
237972|NCT00440557|"~     The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment~     with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not~     less effective than the approved treatment with epoetin alfa that is given 3 times weekly~     with respect to changes in hemoglobin.~   "
237932|NCT00441077|"~     This study will examine how to communicate with an underserved population about inherited~     disease risks. It will present information about inherited risk to a Latino population~     through either a lay health advisor (LHA) or through printed information. The LHA is a member~     of the Latino community who has received training in public speaking, group facilitation, and~     managing group dynamics and in family health history and genetics. Previous studies have~     shown that an LHA can effectively communicate health information to diverse audiences, but~     such interventions have not been studied in the context of inherited risk.~      Spanish-speaking Latino men and women over the age of 18 in the Oakland, CA, and Washington,~     DC, areas who have basic Spanish reading and writing skills may be eligible for this study.~      Participants are recruited to one of two groups. One group participates in group educational~     sessions with an LHA about inherited disease risks and family health history, and the other~     receives this information from a brochure.~      Educational Sessions~      Groups of 5 to 8 individuals complete a questionnaire and then participate in a 45-minute~     educational session on concepts related to genetics, family health history, lifestyle and~     environment. Participants engage in role-playing to practice discussing family health history~     with family members. The LHA teaches participants the skills needed to fill in family health~     history tool called My Family Health Portrait and answers questions. After the question and~     answer session, participants complete a second questionnaire.~      Brochure-Only~      Participants complete a questionnaire and then read a Spanish-language brochure produced by~     the U.S. Surgeon General's Office about the importance of knowing one's family history. They~     then complete a second questionnaire.~   "
237933|NCT00441064|"~     This study will compare the effects of high and low level sodium (salt) diets on blood~     pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.~   "
237934|NCT00441051|"~     Diclofenac sodium 0.1% will be applied to sunburned skin when the intensity of pain reaches a~     certain level in order to evaluate the efficacy and safety of the treatment on this induced~     pain.~   "
237935|NCT00441038|"~     The primary purpose of this study is to compare, in retired persons living in the Balearic~     Islands, the effectiveness on low back pain related disability of three educational programs.~     All consist of a group talk and the handout of a booklet, each one different in its content.~   "
237936|NCT00441025|"~     The purpose of this study is to determine whether the treatment of Alemtuzumab in combination~     with CHOP(cyclophosphamide,doxorubicin,vincristine and prednisolone) are effective as first~     line treatment in patients with peripheral T-cell lymphoma.~   "
237937|NCT00441012|"~     To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus)~     in healthy infants using a modified process in a combination Haemophilus Influenzae, type~     b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B~     vaccine~   "
237938|NCT00440999|"~     The purpose of this study is to compare the efficacy and safety of the fixed combination of~     pyronaridine artesunate (180:60 mg) with that of standard chloroquine therapy in children and~     adults with acute, uncomplicated Plasmodium vivax malaria.~   "
237939|NCT00440986|"~     The purpose of study is to determine the best and durable choice of treatment between~     phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH~   "
237940|NCT00440973|"~     The purpose of this study is to determine if the combination of therapy to strengthen the~     immune system (Interleukin - 2) plus a specific tumor target therapy (Bevacizumab) can~     prolong the time between the start of treatment and disease progression, decrease tumor size,~     as well as determine if the combination therapy is safer and less toxic than the standard~     treatment for renal cell carcinoma.~   "
237941|NCT00440960|"~     The objective of the study was to establish which anesthetic procedure used during flexible~     bronchoscopy has the lowest index of complications.~   "
237942|NCT00440947|"~     This study was designed to test the efficacy, safety, tolerability and durability of the~     antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC)~     Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by~     randomization to either a simplification regimen of ATV or continuation of ATV +/r for an~     additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1~     infected, HLA-B*5701 negative subjects.~      All subjects who complete the 84-week study will be eligible to enter the treatment extension~     phase and continue for an additional 60 weeks. The purpose of this extension is to obtain~     longer term treatment data in subjects who have completed the 84-week study.~   "
237943|NCT00440934|"~     Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one~     million two hundred thousand new patients are diagnosed each year. The prognosis of patients~     suffering from advanced hepatocarcinoma is poor with an average survival of less than six~     months. Phase I data suggest that low levels of electromagnetic fields administered~     intrabucally with a portable and programmable device are a safe and potentially effective~     treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the~     patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options~     will be offered treatment with a combination of frequencies.~   "
237944|NCT00440921|"~     -  Thermogenesis is a company that sells a machine for the production of fibrin sealant of~          single donor plasma, the CryoSeal Fibrin Sealant System (CS-1).~        -  Fibrin sealant consists of two components: cryoprecipitate and thrombin. Cryoprecipitate~          is the fraction of human plasma that contains concentrated coagulation factors, such as~          fibrinogen. Thrombin is an enzyme that facilitates the conversion of fibrinogen into~          fibrin, so that a clot will be formed.~        -  Fibrin sealant can be used in surgery to increase hemostasis in the wound after e.g.~          knee- or hip replacement, cosmetical surgery or partial liverresections.~        -  Until now, mainly autologous plasma was used to produce fibrin sealant with the CS-1.~          Within Sanquin there is a question whether fibrin sealant can be produced from the~          allogeneic quarantaine plasma that is in stock. Therefore in this study will be studied~          whether allogenous single donor fibrin sealant produced using the CS-1 is effective in~          wound healing and as consequence of this can be registered as a product of Sanquin. To~          answer these questions a national working party is formed, working party Fibrin Sealant.~        -  So far, three man personnel in Sanquin Blood Bank Nort East Region (SBNO) are certified~          by Thermogenesis to use the CS-1 for production of fibrin sealant and an in vitro~          validation has been performed.~        -  The next step will be a study for the in vivo effectiveness of fibrin sealant produced~          of single donor allogeneic quarantaine plasma using the CS-1. As control patients~          without fibrin sealant treatment will be studied. Two hospitals (Refaja Hospital in~          Stadskanaal and Wilhelmina hospital in Assen) are already interested in participating in~          this study. Probably, three more hospitals will participate.~        -  The use of fibrin sealant will be studied in a prospective randomized trial for patients~          undergoing knee and hip replacements.~   "
238081|NCT00439140|"~     This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of~     urinary incontinence overactive bladder in patients with a spinal cord injury or multiple~     sclerosis.~   "
237945|NCT00440908|"~     The study is a prospective cohort trial utilizing sequential laboratory results from excess~     serum obtained from hemodialysis patients (acting as their own controls). The objective of~     this study is to determine the impact of converting from reuse to single use of dialyzers on~     specific markers of nutrition (pre-albumin) and inflammation (CRP) in hemodialysis patients~     followed over a period of 6-months after conversion. The Hypothesis is: Comparing values~     obtained at baseline to values at the end of 6-months after conversion from reuse to single~     use in the same patients:~        1. In patients with baseline CRP > 5 mg/L: Mean decrease of 5 mg/L~        2. In patients with baseline CRP < 5 mg/L: > 95% will remain < 5 mg/L~        3. Mean serum pre-albumin levels will increase by at least 3 mg/dL. The study population~          will be drawn from ~2,900 patients that are currently undergoing hemodialysis in 48~          dialysis units that have been identified as continuing to reuse dialyzers and~          specifically are using a peracetic acid-based disinfectant (Renalin®), as of February 1,~          2007. These facilities will be scheduled to convert to single use of dialyzers between~          May and December, 2007. The selection of patients will depend solely on the facility~          conversion date, on a first-come, first-served basis. All patients within the dialysis~          facility that provide blood specimen for their routine monthly lab draws will be~          eligible. The facilities and patients will be enrolled consecutively until the desired~          sample size of approximately 2,500 patients is reached~   "
237946|NCT00440895|"~     -  Abciximab administration is safe and reduces ischemic complications in patients~          undergoing rescue PCI after failed thrombolysis compared to placebo.~        -  Abciximab improves angiographic scores and ventricular function after rescue-PCI~          compared to placebo.~        -  Intracoronary abciximab administration is more effective than intravenous route of~          administration in terms of acute and mid-term angiographic and clinical results.~        -  Intracoronary and intravenous bolus administration of abciximab dose provides similar~          platelet aggregation inhibition (PAI).~        -  There is a significant relationship between PAI after abciximab administration and~          indexes of myocardial perfusion.~        -  Routine use of Sirolimus-eluting stents (Cypher, Cordis, US) in rescue-PCI is associated~          with a low rate of target vessel revascularization.~        -  Cardiac MRI early and late after rescue-PCI provides detailed information on myocardial~          injury and irreversible necrosis, which are correlated with angiographic perfusion~          scores.~        -  After uncomplicated trans-radial rescue PCI, patients can be retransferred early to~          their referring center.~   "
237947|NCT00440882|"~     Transforming Growth Factor-b1 (TGF-b1) is involved in the development of acute lung injury~     and in the fibroproliferation during acute respiratory distress syndrome (ARDS). Procollagen~     III Peptide (PIIINP) is a validated marker of fibroproliferation. PIIINP is associated with~     death in ARDS patients. The simultaneous changes of TGF-b1 and PIIINP were never studied in~     patients with ARDS. The relationships between TGF-b1 and the outcome of ARDS are unknown.~      The aim of the study is to analyse the changes of TGF-b1 and PIIINP during ARDS and to show~     the relationships between TGF-b1 - PIIINP and the outcomes of ARDS.~   "
237948|NCT00440869|"~     The purposes of the study are to determine whether oxidative stress causes the muscle of~     dialysis patients to tire more quickly than muscle of people without kidney disease and to~     determine whether treatment with N-acetylcysteine, an antioxidant, can improve muscle~     endurance.~   "
237949|NCT00440856|"~     The trial aims to assess the hypothesis that presentation of the disc material to the patient~     following a lumbar microdiscectomy would positively influence the improvement in their leg~     and back symptoms.~   "
237950|NCT00440843|"~     Individuals with schizophrenia frequently have impairments in attention. These impairments~     have been shown to be related to overall functioning. Some research suggests that Olanzapine~     may be associated with improvement in various aspects of attention. The primary purpose of~     this study is to determine whether switching from a typical antipsychotic to Olanzapine~     improves task engagement. Individuals who taking typical antipsychotics will be randomly~     assigned to either 1) remain on their typical antipsychotic medications, or 2) be switched~     from their typical antipsychotic medications to Olanzapine. All participants will be enrolled~     in a twice-weekly 20 session cognitive training program that is specifically designed to~     target attention deficits and promote active engagement. Improvements in attention will be~     compared between individuals who remained on their typical antipsychotic medications and~     those that were switched to Olanzapine.~   "
237951|NCT00440830|"~     Effect of nicotine patch as an adjutant for acute pain after surgery.~   "
237952|NCT00440817|"~     The purpose of this study is to examine the association with EBV infection, monitor the~     occurrence of lymphoma and assess lymphoma risk in patients with rheumatoid arthritis and/or~     Crohns disease and you have taken infliximab.~   "
237953|NCT00440804|"~     The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine~     iv in premature infants in the early treatment of Patent Ductus Arteriosus.~   "
237954|NCT00440791|"~     This multi-center, prospective, cohort study of 394 subjects that are indicated for standard~     colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System~     and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims a. To~     evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard~     colonoscopy. This study will evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE)~   "
237955|NCT00440778|"~     HYPOTHESES~        1. Bolus administration of total abciximab dose provides superior maximal and mean platelet~          aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration.~        2. Total dose of abciximab can be given as a single bolus and is more effective than bolus~          (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical~          results.~        3. Intracoronary (ic) abciximab administration is more effective than intravenous (iv)~          route of administration in terms of acute and mid-term angiographic and clinical~          results.~        4. There is a relationship between PAI and angiographic perfusion scores.~        5. Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated~          with a low rate of target vessel revascularization and complications.~        6. Cardiac MRI early and late after primary-PCI provides detailed information on myocardial~          injury and irreversible necrosis, which are correlated with angiographic perfusion~          scores.~        7. After uncomplicated trans-radial PCI, patients can be retransferred early to their~          referring center.~   "
237959|NCT00440726|"~     This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy~     drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred).~     Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for~     treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been~     shown to cause cancer cells to die in studies done on animals (mice). Studies have been done~     that have shown that some adults and children with cancer have shown a response to bortezomib~     when it is used alone. Studies have also been done in adults to evaluate the dose of~     bortezomib that can be safely given in combination with other chemotherapy drugs.~      The Phase I portion of this study is complete and the dose for the phase II portion of the~     study is 1.3mg/m2/day. The phase II portion of the study is open and accruing.~   "
237960|NCT00440713|"~     32 outpatients with a Posttraumatic Stress Disorder were included in a randomized comparative~     single-blind study to study the efficacy of aripiprazole to treat post-traumatic stress~     symptoms.~      The hypothesis is that aripiprazole has an efficacy to reduce PTSD symptoms~   "
237961|NCT00440700|"~     The purpose of this study is to test whether patients who are receiving mechanical~     ventilation in the ICU who listened to preferred, relaxing music whenever they desire for as~     long as they desire will have less anxiety, receive fewer medications, stay in the ICU for a~     shorter time, and experience less stress than patients who do not listen to music.~   "
237962|NCT00440687|"~     Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe~     chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care~     and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from~     COPD patients in primary care is unknown.This randomised double-blind placebo-controlled~     trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD~     recruited from general practice. Participants will have a clinical and spirometric diagnosis~     of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the~     trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler)~     or an identical placebo inhaler. Patients will be monitored using diary cards for a year with~     3 monthly follow-up visits at their general practice. The primary outcome measures will be~     exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs,~     health status, lung function and unscheduled care. We tested the hypothesis that withdrawal~     of ICS in this population would lead to an increased number of exacerbations, earlier onset~     of exacerbation, and a worsening of symptoms.~   "
237963|NCT00440674|"~     The primary objective of this study is to evaluate the safety and effectiveness of a direct~     stenting technique compared to conventional stenting with pre-dilatation strategy using the~     CoStar Paclitaxel-eluting coronary stent system for the treatment of a single de novo lesion~     in a native coronary artery ≤ 25 mm long in a native coronary artery 2.5-3.5 mm diameter.~   "
237964|NCT00440661|"~     Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of~     osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of~     diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation~     mediators.~   "
237965|NCT00440648|"~     This is a double-blind, randomized, cross-over study conducted at centers within the United~     States. The study consists of five periods: an up to two-week Screening Period, a 5-week~     Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients~     are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight~     weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for~     eight weeks followed by sevelamer carbonate for eight weeks~   "
237966|NCT00440635|"~     The purpose of this study is to provide bortezomib to patients with multiple myeloma who have~     received at least 2 previous lines of therapy and are refractory or have relapse after their~     last treatment. Additional objectives of this study are assess the safety and tolerability of~     bortezomib and follow the levels of paraprotein in patients receiving bortezomib as a way to~     followup disease burden~   "
237967|NCT00440622|"~     The optimal treatment for pretreated patients with metastatic breast cancer has not been~     established. Gemcitabine and capecitabine are two active agents in this setting. For women~     with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine~     (Xeloda) plus Herceptin has been proved active and well tolerated.~   "
237968|NCT00440609|"~     The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in~     patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare~     treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and~     2.0mg Ranibizumab.~   "
237969|NCT00440596|"~     Nearly 60 million adults in the United States have high blood pressure (BP) in the~     pre-hypertension (SBP 120-139 or DBP 80-89). Hypertension is estimated to account for 1 in 8~     deaths in the world, and in the US the direct and indirect costs of high BP are estimated to~     reach $59.7 billion in 2005. JNC-7 guidelines recommend lifestyle modifications for~     prehypertension, followed by antihypertensive medication if BP progresses to Stage I~     hypertension. Mindfulness-based Stress Reduction (MBSR) is an increasingly popular practice~     that has been purported to alleviate stress and treat certain health conditions. Some stress~     management therapies and one meditation therapy (e.g., Transcendental Meditation) have shown~     promise in reducing elevated BP, but MBSR has not been evaluated as a treatment for high BP.~     When added to lifestyle modification advice, MBSR may be an appropriate complementary~     treatment for prehypertension. However, prior to a large randomized clinical trial of MBSR~     for prehypertension and/or hypertension, pilot data is necessary to provide preliminary~     evidence of a treatment effect and to evaluate feasibility. This feasibility randomized~     clinical trial of MBSR for unmedicated prehypertension will provide preliminary evidence to~     support a larger randomized clinical trial by evaluating the feasibility and safety of MBSR~     as a complementary treatment for high BP and by documenting any treatment effect. Sixty~     patients with unmedicated BP in the range of SBP 120-139 mm Hg or DBP 80-89 mm Hg will be~     randomly assigned to MBSR or a progressive muscle relaxation control condition. All patients~     will receive lifestyle modification advice. Patients will complete 8 weeks of MBSR delivered~     in a group format by an experienced psychologist trained in MBSR or 8 weeks of progressive~     muscle relaxation training matched for therapist contact and homework. Patients BP will be~     assessed prior to randomization and following treatment by researchers blind to treatment~     assignment. Accrual rates, acceptance of randomization, treatment adherence, treatment~     fidelity, and patient satisfaction with treatment will be evaluated.~   "
237970|NCT00440583|"~     The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients~     with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial~     remission after 6 cycles of CHOP therapy.~   "
237971|NCT00440570|"~     In vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may~     modify cell growth. We have identified specific frequencies that may block cancer cell~     growth. We have developed a device delivering low levels of amplitude-modulated~     electromagnetic fields. The device is connected to a spoon-like coupler, which is placed in~     the patient's mouth during treatment. We will conduct a feasibility study consisting of three~     daily ambulatory treatments until disease progression.~   "
237973|NCT00440544|"~     The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two~     nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed~     with a toxoid adjuvant, causes untoward adverse reactions when administered to healthy adult~     volunteers. Both subjects who have not received Bacillus Calmette-Guerin (BCG) and subjects~     who have already received BCG will be enrolled. An initial evaluation of immune responses to~     the vaccine will also be undertaken.~   "
237974|NCT00440531|"~     The purpose of this trial is to determine if there is an improvement in the immune response~     of older adults over 50 years of age using a modified process hepatitis B vaccine and a~     currently licensed hepatitis B vaccine (RECOMBIVAX HB™).~   "
237975|NCT00440518|"~     The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by~     mouth, twice a day for up to 18 weeks to prevent migraines.~   "
237976|NCT00440505|"~     The purpose of this study is to test whether transdermal nicotine reduces pain among women~     with chronic pelvic pain.~   "
237977|NCT00440492|"~     The purpose of this study is to determine if PLA-695 changes the blood concentrations of~     methotrexate when administered together.~   "
237978|NCT00440479|"~     The primary aim of this observational study is to collect safety and effectiveness data for~     bortezomib used at first relapse in a group of multiple myeloma patients who received~     specific and well defined first line treatments within previous clinical studies.~   "
237979|NCT00440466|"~     The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks~     treatment with epoetin alfa, a drug that increases red blood cell production, in patients~     with anemia associated with chronic kidney disease, is not less effective than treatment with~     epoetin alfa that is given once a week~   "
237980|NCT00440453|"~     The aim of the present study is to take stronger action in solving the problems of~     malnutrition in the hospital setting and in the first two months after patient's discharge.~     The main objective is to evaluate the clinical benefit (eg. QoL, body composition and body~     function) of nutritional intervention (nutritional therapy) in a sample of patients at~     nutritional risk according to the NRS 2002.~   "
237981|NCT00440440|"~     The purpose of the study is to find out the effect of replacing testosterone in the form of a~     gel (Androgel®) on the amount of fat mass in males with low testosterone and diabetes.~   "
237982|NCT00440427|"~     To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to~     healthy subjects.~   "
237983|NCT00440414|"~     The second-line treatment in advanced NSCLC has been currently proved effective in prolonging~     overall survival and improving quality of life. Both pemetrexed and erlotinib have been~     approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the~     treatment of advanced NSCLC, especially for elderly patients, due to convenience of~     administration and safety profile. The role of comprehensive geriatric assessment in~     treatment efficacy and tolerance is an area of investigation.~   "
237984|NCT00440401|"~     To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery~   "
237985|NCT00440388|"~     This is a phase II clinical trial in patients who have not received systemic treatment for~     follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this~     disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the~     rituximab regimen, improvement to patients' response to the treatment will be observed verses~     rituximab alone.~   "
237986|NCT00440375|"~     The purpose of this study is to evaluate the effect of rosiglitazone on bone metabolism and~     to assess the association between the changes in bone turnover parameters and plasma cytokine~     levels in postmenopausal diabetic women~   "
237987|NCT00440362|"~     AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate~     vaccine against influenza.~      The objectives of this Phase 1 study are to test the safety of the vaccine and the immune~     response to the vaccine in healthy volunteers 18-40 years of age. Volunteers will be assigned~     by randomization to receive either the vaccine or an inactive substance (placebo) by~     injections in each arm on one or two occasions over 2 months. The study will last 4 months~     and will have a total of 8 visits.~   "
237988|NCT00440349|"~     Idiopathic retroperitoneal fibrosis (IRF) is a rare disease characterised by the presence of~     a retroperitoneal periaortic fibro-inflammatory tissue which may entrap the ureters and cause~     renal failure. The treatment of IRF is not well established. Corticosteroids are frequently~     used, but the anti-estrogen agent tamoxifen has also been reported to be effective in a~     number of reports. However, no randomised trials have been published so far. The aim of the~     present study is to compare the efficacy of prednisone and tamoxifen in the treatment of IRF.~   "
237989|NCT00440336|"~     WHAT IS THIS STUDY ABOUT? Glaucoma and ocular hypertension are chronic eye diseases that can~     damage the optic nerve and lead to vision loss or blindness. The optic nerve acts like an~     electric cable with over a million wires. This nerve is responsible for carrying images from~     the eye to the brain. The way glaucoma and ocular hypertension cause blindness depends on~     many factors, but the most important factor is the increased pressure inside the eye~     (intraocular pressure).~      There is no cure for glaucoma or ocular hypertension. However, lowering the pressure inside~     the eye has been shown to slow the progression of disease. Intraocular pressure can be~     lowered by glaucoma medication, laser treatment, or surgery.~      You have open angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension. Researchers~     want to find out more about how 2 drugs called Cosopt (dorzolamide hydrochloride and timolol~     maleate) and Xalatan (latanoprost) can help people with these conditions.~      Cosopt and Xalatan are both eye drops that are approved by the U.S. Food and Drug~     Administration (FDA) to reduce intraocular pressure in people with open angle glaucoma and~     ocular hypertension.~      The study doctor will do a laser procedure called Selective Laser Trabeculoplasty (SLT) on~     people in this study to help lower their intraocular pressure. The FDA has approved SLT to~     treat open angle glaucoma and ocular hypertension.~      Then the study doctor will ask some participants to use either Cosopt or Xalatan, if their~     intraocular pressure is still too high 4 to 6 weeks after the SLT procedure. The study doctor~     wants to see which of the 2 study drugs (Cosopt or Xalatan) is better at reducing intraocular~     pressure after SLT.~      It is planned that about 30 people with glaucoma or ocular hypertension who are at least 18~     years old will be in this study. Out of the participants whose intraocular pressure is still~     too high after SLT, half will use Cosopt and half will use Xalatan. You do not have to be in~     this study to have SLT or to use Cosopt or Xalatan.~   "
237990|NCT00440323|"~     Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG~     nights, study drug administration and noise model is conducted on second night.~   "
238006|NCT00440115|"~     The primary aim of this study is to assess the effectiveness of both high and low intensity,~     disease management programs for smoking. The hypotheses are to compare abstinence from~     cigarettes, the number of quit attempts, and smokers motivation at 24 months between~     participants receiving high and low intensity disease management and those receiving usual~     care.~   "
238007|NCT00440102|"~     The expected benefit is a reduction of the morbidity of patients admitted in the intensive~     care unit having received ketamine for intubation.~   "
237991|NCT00440310|"~     The purpose of the study is to assess the overall survival and progression free survival of~     patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of~     Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™~     therapy.~      Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology,~     Bellevue, Washington), and a light generating device, composed of light-emitting diodes~     (LEDs), that is energized by a power controller and percutaneously placed in the target tumor~     tissue inside the body.~   "
237992|NCT00440297|"~     To describe the immunogenicity and safety of modified process hepatitis B vaccine~     administered to renal predialysis and dialysis patients~   "
237993|NCT00440284|"~     Objective. Flexible, intensive insulin therapy (FIT) with pre-prandial regular insulin and~     conventional insulin therapy (CIT) with twice daily premixed insulin are treatment options in~     patients with type 2 diabetes who become insulin dependent. While intensive insulin therapy~     can increase meal and life style flexibility, conventional therapy is easier to perform. The~     aim of the study was to compare metabolic outcomes and patient preferences of both treatment~     regimens.~      Research Design and Methods. Non-blinded, randomized controlled cross-over clinical pilot~     trial. Insulin naive participants who failed therapeutic goals under oral antidiabetic~     therapy underwent FIT and CIT for two months. Patients completed standard Diabetes Treatment~     and Teaching Programs (DTTP) and trained FIT and CIT. Main outcome measures were glycosylated~     hemoglobin (GHb), mild and severe hypoglycemia, insulin dosage, blood pressure and~     body-mass-index (BMI). Before/after and inter-group analyses were performed. Finally, therapy~     preference was analyzed.~   "
237994|NCT00440271|"~     The primary purpose of this study is to:~        1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially~          diverse HIV+ population (males and females) who are three-class (nucleoside reverse~          transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI),~          and protease inhibitor (PI)) experienced with documented resistance to more than one PI.~        2. Determine pharmacokinetic data in this racially and gender diverse population.~        3. Determine the potential utility of using therapeutic drug monitoring (TDM) in improving~          efficacy outcomes.~   "
237995|NCT00440258|"~     The present study was designed to provide clinical confirmation of Cb2’s value as a new~     approach in the prevention of increased vascular permeability and hemoconcentration, both~     signs of OHSS in humans, and in order to explore its mechanism of action. To this end, a~     prospective, randomized, placebo-controlled study was designed in which Cb2 was employed in~     women at risk of OHSS after gonadotropin administration for ART. Simultaneously, ovarian~     perfusion was assessed in these patients using MR pharmacokinetic modeling.~   "
237996|NCT00440245|"~     This study will investigate potential differences in how two puffs of salbutamol protects~     airway smooth muscle from contracting in people with asthma and chronic obstructive pulmonary~     disease (COPD).~   "
237997|NCT00440232|"~     We are testing the hypothesis that subjects in the treatment group will experience fewer~     fasting induced headaches as compared to those in the placebo group.In our clinical~     experience, we estimate that approximately 25% of our headache population experiences~     fasting-induced migraine or hunger-induced migraine. With a given migraine incidence of 28~     million in the United States alone, we estimate that approximately 7 million will experience~     hunger as a migraine trigger. If an individual has a known migraine trigger, then there are a~     variety of ways to modify care in order to address that trigger. The simplest is to avoid~     that trigger or preemptively treat that trigger. Frovatriptan has good evidence for daily use~     for a short time to help prevent menstrually related migraines. A short course of treatment~     can often avoid the initiation of the migraine and improve quality of life. Knowing that a~     longer acting triptan, such as frovatriptan, has demonstrated capability at suppressing~     headache through a known trigger, suggests the need to study this with fasting induced~     migraines, as well.~   "
237998|NCT00440219|"~     This study aims to determine if a short course of oral prednisone helps to improve the~     operative field and ease of surgery by minimizing bleeding during nasal polypectomy surgery.~   "
237999|NCT00440206|"~     Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral~     therapy.~   "
238000|NCT00440193|"~     This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority~     program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with~     confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).~   "
238001|NCT00440180|"~     Obesity is associated with an increase in blood levels of estrogen. Estrogen or female~     hormone is believed to have a negative effect on sperm production. Aromatase inhibitors such~     as anastrozole work to decrease the production of estrogen and increase testosterone in the~     body. By decreasing the level of estrogen, sperm production should improve. In this study,~     the investigators will try to determine the benefit of anastrozole in obese men and follow~     pregnancy outcomes.~   "
238002|NCT00440167|"~     This crossover trial is performed in advanced and metastatic pancreatic cancer not previously~     exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to~     an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to~     incorporate second-line treatment into the study design. Patient who fail on first-line~     therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore~     not only compares two different regimens of first-line treatment, it also compares two~     sequential treatment strategies.~   "
238003|NCT00440154|"~     The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a~     period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other~     lipid plasma levels and the safety and tolerability of AVE5530.~   "
238004|NCT00440141|"~     Patients with glaucoma or ocular hypertension currently being treated with latanoprost~     0.005%, and in need of additional IOP lowering will be randomized to receive either~     brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost~     0.005%~   "
238005|NCT00440128|"~     The purpose of the study is to evaluate the effect of the study drug (GW679769) on a commonly~     used chemotherapy drug (docetaxel) which will be given I.V. Blood samples will be taken to~     see if the GW679769 alters the blood levels of the chemotherapy. The study will last about 2~     weeks with a final follow-up visit 6 weeks later.~   "
238010|NCT00440063|"~     This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in~     the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and~     effective as 4 weekly monitoring. Patients with chronic kidney disease will receive~     NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will~     be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters,~     either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the~     target sample size is 100-500 inidividuals.~   "
238011|NCT00440050|"~     The purpose of this study is to determine whether chronic DHA (Docosahexaenoic Acid)~     supplementation slows the progression of cognitive and functional decline in mild to moderate~     Alzheimer's disease (AD).~   "
238012|NCT00440037|"~     The purpose of this study is to assess the safety and efficacy of long term dosing of AMG 531~     in thrombocytopenic Japanese subjects with ITP.~      It is anticipated that AMG 531 will be a safe and well tolerated in long term treatment and~     that AMG 531 will effectively raise and maintain platelet counts to a desired therapeutic~     range, when individual dose adjustments based on platelet counts are permitted.~      This study is available to subjects who have completed any previous AMG 531 ITP study in~     Japan and meet the eligibility criteria of this study.~   "
238013|NCT00440024|"~     Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by~     features such as wrinkling, uneven skin color, roughness and brown spots. An effective~     treatment for sun-damage that is commonly prescribed is topical retinoic acid (RA). However,~     the major drawback of topical RA use has been frequently observed irritation characterized by~     redness, dry skin and severe itching. In this study, we examine whether a daily skin care~     regimen comprised of an ultra mild cleanser and an effective moisturizer can help improve~     tolerance to RA treatment.~   "
238014|NCT00440011|"~     Patients with glaucoma or ocular hypertension currently being treated with latanoprost~     0.005%, and in need of additional IOP lowering, will be randomized to receive either~     bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%~   "
238015|NCT00439998|"~     The efficacy of an epidural depends mainly on accurate placement of the catheter in the~     epidural space. Therefore, identification of the epidural space is the most vital part of the~     procedure. Obese patients represent the most challenging group for the identification of~     anatomical landmarks. With the use of ultrasound, we can visualize the images of the~     anatomical structures in the back. Some anesthesiologists believe ultrasound can help in the~     placement of an epidural, and routinely use it to assist in determining needle entry point in~     your back as well as estimating the depth at which the epidural space will be found. Our~     hypothesis is that the use of lumbar spine ultrasound imaging will accurately determine the~     epidural space depth and the epidural insertion point in obese patients.~   "
238016|NCT00439985|"~     : Although intervention or prevention with young children with T1DM may help ameliorate~     problems or forestall later problems in metabolic control, a number of potential barriers to~     research have constrained the development of such interventions. To assess the feasibility of~     intervening with young children and their families, we propose to conduct an exploratory~     pilot study of a behavioral intervention for young children (ages 7 to 11) newly diagnosed~     with T1DM. The intervention, derived from the pediatric prevention work of Seligman and his~     colleagues, seeks to apply positive psychology principles to enhance optimism, self-efficacy,~     and parent-child collaboration in diabetes management, in order to improve quality of life,~     adherence, and metabolic control. This exploratory study will allow us to evaluate the~     feasibility of intervening with young children and their caretakers and to estimate~     intervention effect sizes in preparation for a randomized controlled clinical trial.~   "
238017|NCT00439972|"~     The purpose of this study is to compare the effects of oral versus patch administration of~     hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors~     and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and~     flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration~     of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins~     originating from the liver while patch administration of contraceptive hormones will result~     in greater systemic effects of estrogen on vascular reactivity and antioxidant status.~   "
238018|NCT00439959|"~     This study represents the first administration of GSK625433 in humans. The study is designed~     to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity~     in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be~     investigated.~   "
238019|NCT00439946|"~     The purpose of this 8-week study is to compare the effects of switching from intravenous~     Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved~     therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to~     be mixed daily and is stable at room temperature, so there is no need for ice packs. In~     addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every~     8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication~     pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a~     smaller and lighter medication pump called the Crono Five infusion pump. This study will also~     assess the effect that changing to Remodulin will have on treatment satisfaction and patient~     quality of life.~   "
238020|NCT00439933|"~     Obesity in children and adolescents is associated with morphologic and functional changes of~     the vascular wall, suggesting a potential role of juvenile obesity for the development of~     atherosclerosis later in life. However, no evidence from intervention studies has been~     provided so far that weight loss in obese children can improve vascular function. Therefore~     we designed this study including a cohort of obese children before and after a structured~     weight reduction program in order to answer the question, whether such an intervention can~     improve vascular function and reverse destructive vascular changes.~   "
238021|NCT00439920|"~     The present study aims at verifying the state of the art in what this illness concerns and at~     organizing a centralized samples analysis.~   "
238054|NCT00439491|"~     The aim of the study was to investigate the relationship between insulin resistance and body~     composition in relation to secterion and expression of adipocytokines. Obese subjects undergo~     6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and~     subcutaneous adipose tissue samples are obtained for subsequent analysis. In addition, body~     composition and insulin resistance are measured before and during the diet.~   "
238022|NCT00439907|"~     Rupture of the external anal sphincter occurs in about 4% percent of deliveries. It is not~     clear from other studies whether the results concerning anal function, e.g. fecal continence,~     are better with the overlap repair or end-to-end repair of the injured muscle. The~     researchers randomize women at birth to either overlap or end-to-end when the injury is~     recognized, and examine them one year later with special anal physiologic examinations and a~     validated questionnaire. The hypothesis is that the overlap technique is superior.~   "
238023|NCT00439894|"~     Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide~     additional blood samples for further assessment.~   "
238024|NCT00439881|"~     SB-681323 inhibits the action of an enzyme which is known to contribute to the inflammation~     seen in such conditions as Chronic Obstructive Pulmonary Disease and Rheumatoid Arthritis.~     This study will explore the safety of this drug and its blood levels when given in~     intravenous form to healthy human volunteers.~   "
238025|NCT00439868|"~     This study will be conducted in healthy volunteers to investigate the effect on intraocular~     pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.~   "
238026|NCT00439855|"~     Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as~     anticoagulation for PCI~   "
238027|NCT00439842|"~     The purpose of this study is to help people with heart failure (HF) to manage their HF and to~     prevent rehospitalizations. Another purpose is to test the usefulness of clinical~     appointments and educational videotapes in teaching patients how to manage their HF.~      It is proposed that the group clinic intervention (HFcareGroup)will reduce rehospitalization,~     depression, and improve problem solving related to heart failure symptoms.~   "
238028|NCT00439829|"~     The objective of the study is to elucidate the effect of synchronizing initiation of ovarian~     stimulation treatment with follicular wave emergence in poor responder patients undergoing~     IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle~     will increase the number of follicles recruited and oocytes retrieved.~   "
238029|NCT00439816|"~     To determine racial/ethnic differences in preference for group visits in veterans with poorly~     controlled hypertension (State 2 hypertension) and determine the effect of group visits on~     health outcomes among veterans with poorly controlled hypertension.~   "
238030|NCT00439803|"~     AVX601, a bivalent alphavirus replicon vaccine expressing three CMV proteins (gB, pp65 and~     IE1) is a candidate vaccine against cytomegalovirus (CMV).~      The objectives of this Phase 1 study are to test the safety of the vaccine and the immune~     response to the vaccine in healthy volunteers who have not previously been infected with CMV.~     Volunteers will be assigned by randomization to receive either the vaccine or an inactive~     substance (placebo) by injections in each arm on three occasions over 6 months. The study~     will last 12 months and will have a total of 12 visits.~   "
238031|NCT00439790|"~     The aim of this study is to analyze whether the sympathetic tone, measured indirectly and~     directly by muscle sympathetic nerve activity recording, is elevated in patients with heart~     failure receiving an appropriate shock from their implantable cardiac defibrillator (ICD)~     compared to heart failure patients not receiving a shock from their ICD. All parameters~     measured in this study will be used to build a risk algorithm able to identify heart failure~     patients at high risk for sudden cardiac death who could receive an ICD.~   "
238032|NCT00439777|"~     This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority~     program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with~     confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein~     Thrombosis (DVT) (Einstein-PE).~   "
238033|NCT00439764|"~     The primary purpose of this study is to assess the effectiveness of a brief educational~     program and of an additional program in physical therapy, for the treatment of low back pain~     in Primary Care of the Spanish National Health Service. This is a controlled, cluster~     randomized community trial.~   "
238034|NCT00439751|"~     This is a prospective, multicentre, open-labelled, randomized controlled trial comparing the~     efficacy of immediate versus deferred androgen deprivation therapy (ADT) using goserelin~     (Zoladex®) in men with recurrent prostate cancer after radical radiotherapy.~      1100 patients will be accrued from participating Canadian Urological Oncology Group sites in~     an estimated time of 3 years. First analysis is planned for 7 years after study recruitment~     is completed.~   "
238035|NCT00439738|"~     The purpose of this study is to compare the blood pressure lowering efficacy of~     valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of~     obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.~   "
238036|NCT00439725|"~     This is a multicenter, randomized, double-blind, placebo-controlled, event-driven,~     superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein~     thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with~     rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension~     study).~   "
238037|NCT00439712|"~     The purpose of this study is to show that in patients suffering from perennial allergic~     rhinitis levocetirizine 5 mg OD relieves nasal obstruction. Furthermore the study is to~     investigate how relevant for these patients their nasal obstruction and the effect of~     levocetirizine on their nasal obstruction are.~   "
238038|NCT00439699|"~     The purpose of this study is to obtain information on whether or not the medication Memantine~     reduces tremor in persons with essential tremor and is well-tolerated.~   "
238039|NCT00439686|"~     The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.~   "
238040|NCT00439673|"~     The primary objective of the trial is to assess the activity of the combined use of Valproic~     Acid (VPA)in combination with 5-Azacytidine (5-Aza C) in the treatment of MDS.~      Activity will be evaluated as percentage of patients achieving complete or partial remission.~   "
238041|NCT00439660|"~     This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of~     the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy~     non-malnourished infants aged 8-20 weeks at three different dosage levels i.e.10^4.0, 10^5.0~     and 10^6.0 FFU and for three administrations of each of these dosages given to infants at~     4-week intervals. 180 infants (90 vaccinees/90 placebo) will be enrolled for each of the~     three dosage levels. The progression from the lower to the next higher dosage will be based~     on approval by the Data Safety Monitoring Board (DSMB) to be constituted by the Department of~     Biotechnology, New Delhi.~   "
238043|NCT00439634|"~     AVE1625 is a new potent and selective cannabinoid 1 (CB1) antagonist in clinical development~     for the treatment of cognitive impairment in patients diagnosed with schizophrenia.~      The main objective of this study is to evaluate the efficacy on cognitive impairment of 3~     doses of AVE1625 using a new cognitive battery called Measurement and Treatment Research to~     Improve Cognition in Schizophrenia (MATRICS) in schizophrenic patients.~      The secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the~     patients using a specific scale called University of California San Diego Performance-based~     Skills Assessment 2 (UPSA2) and to assess the safety of the compound.~   "
238044|NCT00439621|"~     The purpose of the study is to evaluate safety and efficacy of three doses and two dosing~     regimens of RP01 as an anti-IgE immunotherapy in allergic patients.~   "
238045|NCT00439608|"~     Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction~     and Gastric Cancer~   "
238046|NCT00439595|"~     A high proportion of children under the age of 5 years and pregnant women in Tanzania is~     anaemic, particularly in areas of high malaria transmission. The symptoms of anaemia are~     often non-specific or absent and clinical judgement is generally insensitive in estimating Hb~     levels, especially in infants who are assessed by basic grade health staff. Thus while~     treatment for the common causes of anaemia is available, many cases are not treated due to~     difficulties in recognising anaemia.~      New diagnostic tools can increase the sensitivity of anaemia detection compared to clinical~     diagnosis but no studies have demonstrated their effectiveness in increasing case-detection~     and treatment of anaemic patients at the first level of healthcare. In addition, the costs of~     their use in relation to any increase in numbers of cases treated are not known and this~     knowledge is needed to guide public health decisions.~      Two methods of measuring anaemia are currently suitable for use at the first level of care;~     Copack Haemoglobin colour scale (HBCS) and Hemocue portable photometry. We propose to compare~     the effectiveness in basic health facilities of these 2 simple diagnostic tools compared to~     control dispensaries (current practice) in increasing rates of detection and treatment of~     anaemia in children under the age of 5 years and pregnant women over the course of 1 year in~     a cluster-randomised trial in 30 dispensaries in a malaria-endemic area of NE Tanzania.~   "
238047|NCT00439582|"~     Background:~      Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially~     hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well~     documented. However, very little information is available on the effect of natural sources of~     TFA coming from milk fat, dairy products and ruminant meat. In fact, due to the naturally low~     level of TFA in milk fat, it is almost impossible to conduct a clinical trial with a limited~     number of subjects.~      Methodology:~      To compare the effects of industrial and natural dietary sources of TFA, two specific test~     fats have been designed and produced. A substantial amount of milk fat (130 kg) enriched in~     TFA has been produced by modification of the cow's diet and selection of cows with the~     highest TFA content. The level obtained was approximately 4- to 7-fold higher than typically~     present in milk fat ( - 20 instead of 3-6 g/100 g of total fatty acids). The control fat is~     composed of PHVO balanced in saturated fatty acids (lauric, myristic and palmitic). Both~     experimental fats contain about 20-22% of monounsaturated TFA and the volunteers' daily~     experimental fat intake (54 g), will represent about 12.0 g/day of TFA or 5.4% of the daily~     energy (based on 2000 kcal/day). These two test fats have been incorporated into food items~     and will be provided to 46 healthy subjects under a randomised, double blind, controlled,~     cross-over design. The primary outcome is high-density lipoprotein cholesterol (HDL-C), which~     is an independent risk factor for CVD. Other parameters such as lipoprotein cholesterol~     (LDL-C), very low-density lipoprotein cholesterol (VLDL-C), and HDL-C level and subclasses~     will be also to be evaluated.~   "
238048|NCT00439569|"~     The purpose of this study is to identify the maximum tolerated dosage of sodium~     phenylbutyrate in children with spinal muscular atrophy types II or III; and to determine if~     the drug has an effect on SMN mRNA and protein levels.~   "
238049|NCT00439556|"~     The goal of this clinical research study is to find the highest tolerable dose of Velcade~     (bortezomib) that can be given with BEAM (carmustine, etoposide, cytarabine and melphalan)~     and rituximab in patients with lymphoma who receive a stem cell transplant.~   "
238050|NCT00439543|"~     Idiopathic pulmonary fibrosis(IPF) is chronic progressive fibrosing lung disease of unknown~     cause. There is no effective therapy yet for this disease and the mean survival in most~     reports is about 3 years after the diagnosis. Because of the stiff fibrosis of the lung,~     pulmonary hypertension is the late complication of IPF and its development heralds a very~     poor outcome of the patients. For the primary pulmonary hypertension, recently the effective~     drugs have been available. However, there is no study about the efficacy of these drugs in~     the patients with pulmonary hypertension secondary to pulmnary fibrosis, and the aim of this~     trial is to study the safty and efficacy of Iloprost, one of the safe and effective drugs~     in primary pulmonary hypertension.~   "
238051|NCT00439530|"~     Pharmacologic Study of Oseltamivir in Healthy Volunteers is a Phase I study in which 8 to~     32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens~     within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical~     Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy~     volunteers on 23 November 2006. The duration of the study is expected to be approximately~     four months. The goals of this study are to assess the use of loading dose oseltamivir and~     the concomitant use of probenecid and to characterize the pharmacokinetic properties of~     oseltamivir in Thai subjects.~   "
238052|NCT00439517|"~     This is an exploratory study to compare activity and safety in 400 patients with previously~     untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT®~     (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination~     regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)~   "
238053|NCT00439504|"~     The purpose of this study is to determine if there are significant cardiovascular or other~     interactions between sublingual lobeline and intravenous methamphetamine.~   "
238055|NCT00439478|"~     We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine~     therapy for differentiated thyroid cancer.~   "
238696|NCT00430976|"~     The purpose of this study is to assess the effect of aerobic exercise on the brain and~     cognition through the measurement of neuroelectric and behavioral indices of executive~     control cognitive function in older adults.~   "
238056|NCT00439465|"~     The purpose of this study is to determine whether the administration of highly effective~     killer cells (cytotoxic T cells), along with IL-2 and GM-CSF immediately following~     Autologous Peripheral Blood Stem Cell Transplantation (APBSCT) will enhance anti-tumor immune~     reconstitution and improve outcome of Multiple Myeloma patients.~      The overall hypothesis of this proposal is that immediately following APBSCT the immune~     reconstitution is optimal to administer killer cells, combined with the administration of~     IL-2 and GM-CSF.~   "
238057|NCT00439452|"~     Across the country, Community Health Centers are participating in the Health Disparities~     Collaboratives sponsored by the Health Services Resources and Services Administration (HRSA).~     The Health Disparities Collaboratives integrate three complementary conceptual frameworks: 1)~     the Institute for Healthcare Improvement's (IHI) Breakthrough Series Model; 2) the~     Improvement Model (i.e., Plan-Do-Study-Act cycles); and 3) Wagner's Chronic Care Model. The~     Chronic Care model uses patient self-management, delivery system re-design, decision support,~     and clinical information systems to maximize the effectiveness of interactions between~     prepared proactive care teams and informed activated patients with chronic illnesses such as~     diabetes, asthma, and depression. The Chronic Care model for depression, also known as~     Collaborative Care, involves primary care providers working with a depression care team~     comprising non-physicians (e.g., nurses, pharmacists) and mental health specialists (e.g.,~     psychiatrists). Practice-based collaborative care involves primary care providers working~     with an on-site depression care team. In contrast, telemedicine-based collaborative care~     involves primary care providers working with an off-site depression care team using~     telemedicine technologies. The purpose of this research project is to compare the~     effectiveness and cost effectiveness of practice-based and telemedicine-based collaborative~     care in Community Health Centers (without on-site mental health specialists) implementing the~     Health Disparities Collaborative for depression.~   "
238058|NCT00439439|"~     Globus sensations are associated with gastroesophageal reflux disease as well as the presence~     of a gastric inlet patch. No controlled trial exists on whether ablation of the cervical~     heterotopic mucosa may lead to improvement of chronic globus sensations. The aim of this~     sham-controlled trial is to clarify whether argon-beamer-ablation of cervical heterotopic~     gastric inlet patches of the esophagus improves patients' chronic globus sensations.~   "
238059|NCT00439426|"~     This single arm study will assess the efficacy and safety of Xeloda + oxaliplatin when given~     as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will~     receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7~     days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles.~     The anticipated time on study treatment is until disease progression, and the target sample~     size is <100 individuals.~   "
238060|NCT00439413|"~     The purpose of this study is designed to examine the effects of Selegiline Transdermal System~     and behavioral intervention in smoking cessation as compared to behavioral intervention~     alone.~   "
238061|NCT00439400|"~     The objective of this study is to assess the safety and efficacy of doxycycline 0.025%~     (ALTY-0501) ophthalmic solution for the treatment of dry eye using the Controlled Adverse~     Environment (CAE) Model.~   "
238062|NCT00439387|"~     This study will investigate the role that a brain chemical called serotonin plays in~     seizures. Serotonin, present naturally in the brain, helps transmit signals between nerve~     cells. Glucose is a sugar that is the main fuel of the brain. Studying these two chemicals~     may help explain why people with epilepsy get seizures and are more likely to be depressed.~      Healthy volunteers and patients 18 to 60 years of age who have epilepsy with or without~     depression and whose seizures are not controlled by medication may be eligible for this~     study. Candidates are screened with a review of their medical history, a physical examination~     and an electroencephalogram (EEG, brain wave recording).~      Participants undergo the following procedures:~        -  Positron emission tomography (PET) scans: The first of three PET scans measures brain~          blood flow and the activity at some of the brain serotonin receptors (the parts of brain~          cells to which serotonin attaches). A second scan measures the amount of serotonin~          transported between brain cells. A third scan measures glucose use. The PET scanner is~          shaped like a doughnut. The subject lies on a bed that slides in and out of the scanner~          with his or her head inside the opening. A special mask is fitted to the subject s head~          to help keep it still during the procedure so the images will be clear. For the first~          scan, catheters (plastic tubes) are placed in an arm vein to inject a radioactive~          substance and in an artery in the wrist to collect blood samples. The other two scans~          require only the catheter in the arm.~        -  Magnetic resonance imaging: This test uses a strong magnetic field and radio waves to~          obtain images of the brain. The scanner is a metal cylinder surrounded by a strong~          magnetic field. The subject lies on a table that can slide in and out of the cylinder.~          Most scans last between 45 and 90 minutes. Subjects wear earplugs to muffle loud~          knocking noises that occur during scanning.~        -  Psychological evaluation: Subjects are interviewed and fill out questionnaires to help~          study sadness and depression in epilepsy.~        -  Blood draw: Blood tests look for differences in genes between people with epilepsy who~          are depressed and those who are not.~   "
238063|NCT00439374|"~     The purpose of this study is to see if giving progesterone medication to pregnant women, who~     have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers~     the risk of early delivery and improves the health of their baby.~   "
238064|NCT00439361|"~     Primary Objectives:~        1. To determine the toxicity profile of multiple doses of bortezomib when given with ICE in~          patients with relapsed and refractory classical Hodgkin lymphoma (HL).~        2. To determine the maximum tolerated dose (MTD) of bortezomib when given in combination~          with ICE chemotherapy in patients with relapsed and refractory classical Hodgkin~          lymphoma (HL).~      Secondary Objectives:~      - To determine the overall response rate and complete response rate in patients with relapsed~     and refractory classical Hodgkin lymphoma (HL).~   "
238065|NCT00439348|"~     There are several benefits of over-the-counter medications, yet there is little research~     evaluating how to increase patient compliance when a health care provider suggests an~     over-the-counter (OTC) medication. We are evaluating two types of physician directions to see~     which increases patient compliance with OTC medications.~   "
238066|NCT00439335|"~     This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle~     versus injection in the skin in healthy adults. The study will look at the safety of the~     injections, how the body reacts, and what the body's immune response does when the vaccine is~     given in the muscle versus in the skin. The study will look at 226 healthy volunteers, ages~     18-49 years old. Study procedures will include getting 2 doses of vaccine 28 days apart,~     physical exams, follow-up clinic visits to check the places on the body where each vaccine~     was given, and blood sample collections. Volunteers will complete a memory aid by writing~     down temperatures and health changes for 7 days after each vaccination. Volunteers will be~     involved in the study for up to 241 days.~   "
238067|NCT00439322|"~     Posttraumatic stress disorder (PTSD) occurs in response to an extreme traumatic stressor. It~     is estimated that as many as 1 million VA patients who were exposed to combat may have PTSD.~     VA patients with PTSD recently have been designated as a �Special Emphasis� population for~     which health care resources are allocated at approximately 14 times those allocated to~     patients without such chronic, complex, and intensive health care needs (i.e., �Basic Care�~     groups). Despite recognition of its substantial impact upon VA resources, the extent and~     means by which PTSD affects health and health care use remain unclear. This study seeks to~     enhance understanding of both the extent and means by which PTSD affects the health and the~     health care use of patients in VA ambulatory care. To meet this goal, we build on an ongoing~     HSR&D project, the Veterans Health Study (VHS), a prospective longitudinal study of 2,425 VA~     ambulatory care patients.~   "
238068|NCT00439309|"~     To evaluate a new vascular sealant compared to control for the control of suture line~     bleeding after vascular reconstructive surgery.~   "
238069|NCT00439296|"~     This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott~     Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic~     leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done~     to find the highest dose of ABT-751 that can be given safely in combination with other~     chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects.~     After a safe dose for ABT-751 given with chemotherapy has been found, the study will add~     additional patients to find out if ABT-751 (given at the maximal safe dose) when given with~     additional chemotherapy is an effective therapy for the treatment of children with relapsed~     ALL. It is expected that approximately 15-35 children and young adults will take part in this~     study.~   "
238070|NCT00439283|"~     Continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab~     is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in~     disease relapse, with variable delay. Objective of this study was to compare efficacy between~     a continuous treatment with infliximab, and a treatment adapted to symptoms recurrence.~     Addition of methotrexate (MTX)to infliximab was also tested.~   "
238071|NCT00439270|"~     The purpose of this study is to find the recommended doses of dasatinib and docetaxel given~     in combination to men with metastatic hormone refractory prostate cancer and to assess the~     pharmacokinetic interactions between the 2 drugs.~   "
238072|NCT00439257|"~     The treatment of multiple sclerosis was evolving in light of specific drug therapies to treat~     the disease, refinements and acceptance of imaging with MRI to diagnose and monitor the~     disease process, and progress in understanding the pathogenesis of the inflammatory~     demyelinating process. The result was to raise new issues in the treatment of the disease,~     which are then being addressed by studies, including when to initiate treatment and the~     treatment of partial responders to existing therapies. Paralleling strides in treatment, and~     of particular importance to the Veterans Administration, was the effectiveness of such~     therapies, both in terms of cost to the VA Health Care System and quality of life of veterans~     with multiple sclerosis. This study addressed these issues.~   "
238073|NCT00439244|"~     The purpose of this study is to assess the effects of zoledronic acid administered at the~     same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone~     mineral density (BMD) gain in the lumbar spine and total hip~   "
238074|NCT00439231|"~     This study will evaluate the safety and effectiveness of a new drug called lenalidomide~     (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small~     lymphocytic lymphoma (SLL) who relapsed after their initial treatment.~      Patients 21 years of age and older with CLL or SLL who have previously received standard~     treatment may be eligible for this study.~      Participants take lenalidomide capsules once a day for 21 days, followed by 21 days off the~     drug. This constitutes one treatment cycle. Treatment continues for four cycles as long as~     the medicine is tolerated. After four cycles, patients who respond completely continue~     treatment for another two cycles; patients who respond partially continue treatment for~     another four cycles; and patients who do not respond stop treatment but continue to be~     followed for safety.~   "
238075|NCT00439218|"~     The purpose of this study is to identify the maximum tolerated dosage of sodium~     phenylbutyrate in children with spinal muscular atrophy type I; and to determine if the drug~     has an effect on SMN mRNA and protein levels.~   "
238076|NCT00439205|"~     The goal of this clinical research study is to evaluate an imaging technology that may help~     clinicians see how far an area of pre-cancerous or cancerous tissue extends in the mouth.~   "
238077|NCT00439192|"~     This study is designed to determine the efficacy of escalating doses of ELB245 versus placebo~     , when administered to patients with OAB and to compare the efficacy of escalating doses of~     ELB245 versus the standard treatment tolterodine, when administered to patients with OAB.~   "
238078|NCT00439179|"~     A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary~     Cancer Schema~   "
238079|NCT00439166|"~     This study will determine if biomarkers found in the cerebrospinal fluid of people with~     Alzheimer's disease, are affected by treatment with two common antibiotics, doxycycline and~     rifampicin, suggesting a disease-modifying effect of those treatments.~   "
238080|NCT00439153|"~     Tourniquet cuffs are routinely used to stop blood flow in patients' arms or legs during~     surgery. This allows surgeons to better visualize anatomical structures during the procedure.~     Although complications after surgery are rare, patients sometimes suffer from pain or~     numbness in their limb and redness of the skin in the area where the cuff was applied. Using~     the lowest pressure possible minimizes the chance of these problems. Previous studies,~     conducted on adults, have shown that basing the cuff pressure on the minimum amount of~     pressure necessary to stop blood flow to the limb (known as limb occlusion pressure, or LOP)~     can lead to lower cuff pressures successfully being used. The goal of this study is to~     determine the magnitude by which tourniquet cuff pressure can be reduced in children using a~     tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs selected~     to fit the size and contour of the limb. The tourniquet instrument and cuffs used in this~     study are all commercially available and approved for use with children.~      Hypothesis:~      It is hypothesized that use of a commercially available tourniquet instrument capable of~     calculating limb occlusion pressure in combination with tourniquet cuffs selected and applied~     according to a standardized procedure will produce surgical fields of equal or superior~     quality with significantly lower tourniquet cuff pressures.~   "
238082|NCT00439127|"~     Thyroidectomy followed by administration of large activities of 131-iodine (131I) is the~     treatment of choice for differentiated thyroid carcinoma (DTC). The serum thyroglobulin (Tg)~     measurement during hypothyroidism (offT4-Tg), just before radioiodine thyroid ablation, has~     proved to be effective for predicting persistent/recurrent disease. However, the Tg~     measurement cannot be used as a corresponding value for preablative offT4-Tg when rhTSH is~     used as stimulous before treatment. The present study was undertaken to evaluate if~     post-thyroidectomy Tg values, measured before rhTSH-stimulation and radioiodine~     administration, is of prognostic value in patients affected by DTC. We enrolled 28 patients~     with DTC and submitted to total thyroidectomy. Thyroxine (T4) treatment was started just~     after surgery to suppress TSH levels. Six to nine weeks later Tg levels were measured both~     basally (onT4-Tg) and after rhTSH (rhTSH-Tg) stimulation. Subsequently, T4 was stopped and~     serum Tg measured (offT4-Tg) just before 3700 MBq of 131I-iodide administration. A~     post-treatment whole body scan (PT-WBS) was performed and neck radioiodine uptake (RAIU)~     measured. A significant relationship was found between onT4-Tg and both rhTSH-Tg and~     offT4-Tg. The onT4-Tg levels of 0.2 ng/mL or higher predicted PT-WBS results with a 100%~     negative and 43% positive predictive values, respectively. Additionally onT4-Tg levels of 0.9~     ng/mL or more predicts 12-months recurrences with 100% negative and 60% positive predictive~     value. In comparison, 1.0 ng/mL or higher offT4-Tg values predicted PT-WBS results and~     12-months restaging with 94% and 100% negative and 45% and 27% positive predictive value,~     respectively. Basing on our data we conclude that preablative onT4-Tg may be of value as~     prognostic marker when rhTSH-aided radioiodine ablation is done. Additionally, the role of~     preblative onT4-Tg measurement as a yard-stick for radioiodine ablation should be further~     evaluate.~   "
238083|NCT00439114|"~     This study is planned to compare the results of ultrasonic and Orbscan pachymetry in corneal~     haze not related to surgery. Corneal haze is graded with slit-lamp by a single examiner.~     Ultrasonic and Orbscan II pachymetry measurements are obtained. Paired t and Kruskal-Wallis~     tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry~     measurements. Correlation of the two methods and haze grade is determined with Kendall’s~     tau-b correlation analysis.~   "
238084|NCT00439101|"~     The purpose of this research study is to determine if megestrol acetate can be used as an~     appetite stimulant to improve weight gain in children with cancer and poor nutrition. The~     study design is a randomized, double blind, placebo controlled trial. Secondarily, we would~     like to determine what effect any improvement in weight has on body composition by DEXA scan.~     This includes whether the drug results in an increase in fat, fat-free mass, or both. If our~     patients gain weight we would like to know if it improves their quality of life. Finally,~     many children with cancer lose too much weight and require feeding to occur through a tube~     put down their nose into their stomach (NG feeding). The tube can be painful to put down and~     is uncomfortable when in. Some children may also require nutrition to be given into a vein~     (Total Parenteral Nutrition or TPN). We are trying to see if we can prevent these procedures~     from happening by having the subjects gain weight. This study will tell doctors if the drug~     truly works (or does not work) in children who are underweight.~   "
238085|NCT00439088|"~     The purpose of this study is to compare the accuracies of the Patient Activity Monitor to~     that of a standard pedometer during a walking task and some day-to-day activities in a~     simulated apartment setting.~   "
238086|NCT00439075|"~     Evaluate efficacy and safety of CPAP in a randomised standard treatment controlled study, in~     out-of-hospital patients with acute cardiogenic pulmonary edema.~   "
238087|NCT00439062|"~     The purpose of this study is to evaluate the clinical efficacy, safety, and tolerability of~     roxithromycin in patients with rheumatoid arthritis.~   "
238088|NCT00439049|"~     The overarching goal of this project is to have a consolidated consent and evaluation~     procedure that will lead potential subjects to the most appropriate clinical trial or human~     laboratory study (and its consent process) for their presenting concerns or interests. A~     second purpose is to have a consolidated intake data base on which secondary analyses can be~     conducted.~   "
238089|NCT00439036|"~     The purpose of this study is to develop an opiate detoxification behavior therapy based on~     current Acceptance and Commitment Therapy (ACT) theory and method, and to test its~     feasibility and promise in the context of voluntary methadone detoxification.~   "
238090|NCT00439023|"~     The purposes are~        1. to measure the effect of dialysis with glucose on blood pressure, pulse rate, plasma~          concentration of glucose, plasma concentrations of glucagon, growth hormone, renin,~          angiotensin II, endothelin and body temperature, and~        2. to analysis the relationship between changes in blood pressure on the one hand and~          changes in vasoactive hormones on the other~   "
238091|NCT00439010|"~     The underlying goal of this study is to assess 123-I AV39 SPECT imaging as a tool to detect~     ß-amyloid deposition in the brain of AD research participants and age- and gender-matched~     healthy subjects.~   "
238092|NCT00438984|"~     RATIONALE: Biological therapies, such as therapeutic autologous lymphocytes, may stimulate~     the immune system in different ways and stop tumor cells from growing. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may~     also stimulate the immune system in different ways and stop tumor cells from growing.~     Aldesleukin may stimulate white blood cells to kill tumor cells. Giving therapeutic~     autologous lymphocytes together with cyclophosphamide and aldesleukin may be an effective~     treatment for melanoma.~      PURPOSE: This phase I trial is studying the side effects of giving therapeutic autologous~     lymphocytes together with cyclophosphamide and aldesleukin in treating patients with stage IV~     melanoma~   "
238093|NCT00438971|"~     The purpose of this study is to determine whether duloxetine is effective in the treatment of~     panic disorder.~   "
238094|NCT00438958|"~     RATIONALE: Giving chemotherapy before a donor peripheral stem cell transplant or bone marrow~     transplant using stem cells from a brother or sister that closely match the patient's stem~     cells, helps stop the growth of cancer or abnormal cells. It also helps stop the patient's~     immune system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer or abnormal cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving colony-stimulating factors, such as~     G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can~     be collected and stored. Giving methotrexate and cyclosporine before and after transplant may~     stop this from happening. It is not yet known whether a donor peripheral stem cell transplant~     is more effective than a donor bone marrow transplant in treating hematologic cancers or~     other diseases.~      PURPOSE: This randomized phase III trial is studying filgrastim-mobilized sibling donor~     peripheral stem cell transplant to see how well it works compared with sibling donor bone~     marrow transplant in treating patients with hematologic cancers or other diseases.~   "
238095|NCT00438945|"~     We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan~     reduces the activity of the sympathetic nervous system in patients with essential~     hypertension - during baseline conditions and after activation of the sympathetic nervous~     system.~   "
238096|NCT00438932|"~     The purpose of this study is to learn more about how the kidneys control the blood levels of~     phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this~     information to design improved treatment strategies for phosphorus-related problems for the~     millions of patients with chronic kidney disease.~   "
238097|NCT00438919|"~     This multicenter, prospective, observational registry will evaluate the safety and~     performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, and of all future~     generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine~     clinical practice. Its objective is to measure the incidence and identify the predictors of~     acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE).~     Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent~     restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.~   "
238098|NCT00438906|"~     The purpose of this study is to find the best and most sensitive screening modality (CT, MRI,~     EUS)for very small pre-cancerous pancreatic lesions and to treat these small lesions before~     they turn into cancer. Another purpose of this study is to search for common markers on DNA~     that would increase the chance of someone developing pancreatic cancer, and locate proteins~     in pancreatic juice that indicate tumor development.~   "
238099|NCT00438893|"~     The purpose of this study is to evaluate the long term effectiveness of the dietary~     portfolio, consisting of viscous fibers, soy products, nuts and plant sterols, as well as the~     effects of removing single food components from the dietary portfolio on cholesterol~     reduction and other cardiovascular risk factors.~   "
238100|NCT00438880|"~     RATIONALE: Biological therapies, such as agatolimod sodium, may stimulate the immune system~     in different ways and stop cancer cells from growing. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells~     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab~     tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming~     normal cells. Giving agatolimod sodium together with rituximab and yttrium Y 90 ibritumomab~     tiuxetan may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of agatolimod~     sodium when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see~     how well it works in treating patients with recurrent or refractory non-Hodgkin lymphoma.~   "
238101|NCT00438867|"~     The purpose of this study is to determine whether a one-time intracoronary infusion of~     Ad5FGF-4 is effective in reducing the time to onset myocardial ischemia as measured by~     exercise treadmill testing and improving myocardial blood flow as measured by SPECT imaging.~     Exercise capacity, angina functional class, patient symptoms and quality of life will also be~     evaluated to characterize the efficacy of Ad5FGF-4. Short-term and long-term safety of~     Ad5FGF-4 will also be evaluated.~   "
238102|NCT00438854|"~     The purpose of this research study is to see if Dasatinib is effective and safe to give to~     people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the~     drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme~     in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory~     studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells.~     Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on~     CLL cells.~   "
238103|NCT00438841|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Thalidomide may stop the growth of cancer cells~     by blocking blood flow to the cancer. Giving bortezomib together with cyclophosphamide,~     dexamethasone, and thalidomide may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with~     cyclophosphamide, dexamethasone, and thalidomide works in treating patients with newly~     diagnosed, previously untreated multiple myeloma.~   "
238104|NCT00438828|"~     Radiation treatment is often recommended as a safe and quick treatment that gives most people~     good relief from bone pain within a couple of weeks. However, some people can experience a~     short episode of increased pain (called a 'flare') a day or two after radiation treatment,~     that lasts about a day. The purpose of this sturdy is to find out if a medication called~     dexamethasone can help prevent pain flare as a result of radiation therapy.~   "
238105|NCT00438815|"~     The study objective was to evaluate the safety and efficacy of repeat use of C1INH-nf for the~     treatment of acute HAE attacks.~   "
238106|NCT00438802|"~     RATIONALE: Combinations of biological substances in alefacept may be able to carry~     cancer-killing substances directly to cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in~     treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell~     non-Hodgkin's lymphoma.~   "
238107|NCT00438789|"~     The primary objective is to provide access to eculizumab for PNH patient pending commercial~     availability.~   "
238108|NCT00438776|"~     The purpose of this research study is to evaluate the efficacy (effectiveness) and safety of~     olanzapine in treating pathological gambling.~   "
238109|NCT00438763|"~     Carpometacarpal Thumb Arthritis is a disease caused by different factors and attacks mainly~     woman older than 50 years. The signs and symptoms consist in pain, swelling, joint~     instability, deformity and loss of motion. Some evidence has shown that splinting of the~     thumb may be of benefit. There are two methods of splinting: The first is Standard Neoprene~     wrap-on thumb support (in which the finger is kept in the same position with in a standard~     Neoprene thumb splint). The second is Thermoplast Short Opponens splint (This splint is~     custom-made and the thumb is use as a template to design the splint). The purpose of this~     study is to test and evaluate these two protocols of splinting and assess which one helps or~     works better in patients with thumb arthritis.~   "
238110|NCT00438750|"~     The purpose of this study is to compare to ways of rehabilitating after surgery for distal~     radius fractures treated operatively with a volar plate.~   "
238111|NCT00438737|"~     RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may~     also stop the growth of tumor cells by blocking blood flow to the tumor.Drugs used in~     chemotherapy, such as leucovorin, oxaliplatin, and fluorouracil, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving cetuximab together with combination chemotherapy and bevacizumab before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. Giving these treatments after surgery may kill any tumor cells that remain after~     surgery.~      PURPOSE: This randomized phase II trial is studying the side effects and how well giving~     cetuximab together with leucovorin, oxaliplatin, and fluorouracil works with or without~     bevacizumab in treating patients with resectable liver metastases from colorectal cancer.~   "
238112|NCT00438724|"~     The purpose of this study is to test the efficacy of a new couples counseling intervention~     for people recently diagnosed with early Alzheimer's disease and their spouses. The study~     hypothesis is that counseling the couple shortly after the diagnosis, and while the~     functional impact of the illness is still relatively mild, will have a significant impact on~     their ability to provide support for each other.~   "
238113|NCT00438711|"~     This is a study for people with inflammatory bowel disease (IBD--that is, ulcerative~     colitis, Crohn's colitis, or indeterminate colitis). We are studying how people with IBD~     decide to have surgery when a doctor has told them they should think about having their colon~     (large bowel) removed. This surgery is called a colectomy. Patients will be asked to fill~     out a questionnaire that takes about 60 to 90 minutes to complete. Questions ask about~     patients' background (age, etc.) and their IBD. They also ask about patients' decision to~     have surgery or not to have surgery. For instance, what kinds of things did they think about?~     Some questions ask about other people who affected the choice and how patients felt about the~     help they got from others. People who wish to join the study will receive payment to thank~     them for their time.~        -  Patients must be at least 18 years old~        -  Patients must speak English~        -  Patients must have been told by their doctor to think about having surgery to take out~          their colon to (a) lower their risk for cancer or (b) because they have pre-cancer~          (called dysplasia)~        -  Patients do not need to have had the surgery--they may have already had the surgery,~          they may not have had it yet, or they may have decided they do not want to have it~   "
238114|NCT00438698|"~     Large observational studies have shown cereal fiber to protect from diabetes and heart~     disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers~     the glycemic index of foods containing starch, sucrose and maltodextrins, the use of diets~     containing low glycemic index foods still remains to be established. We will therefore~     provide otherwise healthy individuals with type 2 diabetes intensive counseling on food~     selection either to improve glucose control using high cereal fiber dietary strategies or low~     glycemic index foods. Studies will last 6 months with bloods taken for HbA1c, glucose and~     blood lipids. If the study shows a benefit for either or both diets then use of high fiber~     and/or low glycemic index foods in the diet may provide another potential way to improve~     glucose control and lower cholesterol levels in non-insulin dependent diabetes.~   "
238115|NCT00438685|"~     Adolescent substance abuse results in significant negative outcomes and extraordinary costs~     for youths, their families, communities, and society. Moreover, rates of psychiatric~     comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual~     diagnosis have worse outcomes and are more than twice as costly to treat than their~     counterparts with no comorbidity. This project was a pilot test of a new treatment, OPTION-A,~     which was adapted from Multisystemic Therapist (MST) and other evidence-based interventions~     to specifically treat youth presenting for outpatient treatment of comorbid substance use and~     internalizing disorders. The project was a randomized controlled pilot trial comparing the~     experimental treatment to usual services in the community.~   "
238116|NCT00438672|"~     The purpose of the study is to compare the effectiveness of a steroid injection to a placebo~     (inactive substance) in the treatment of lateral elbow pain, deQuervain's tendonitis, or base~     of the thumb carpometacarpal (CMC) arthritis. We are also trying to identify which~     personality factors and mindsets influence perceptions of elbow, wrist and hand pain. We hope~     to enroll 213 subjects in this study.~   "
238117|NCT00438659|"~     RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis~     caused by radiation therapy. It is not yet known whether mometasone furoate is more effective~     than a placebo in preventing radiation dermatitis.~      PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it~     works compared to a placebo in preventing radiation dermatitis in patients undergoing~     radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma~     in situ.~   "
238118|NCT00438646|"~     This study will see if bacteria differ between children who have allergies or asthma and~     children who do not have allergies or asthma. Previous research suggests that some bacteria~     may protect against allergies and asthma. This study may provide more information on why some~     children develop allergies and asthma.~      Patients at the University of North Carolina-Chapel Hill School of Dentistry who are between~     6 and 11 years of age may be eligible for this study.~      Parents of participating children complete a questionnaire about the child and the child's~     health. The child provides a saliva sample by chewing a small piece of wax and spitting in a~     cup.~      The saliva sample is analyzed in the laboratory for bacteria, yeast and antibodies~     (substances the body produces to fight germs).~   "
238119|NCT00438633|"~     The purpose of the study is to compare two common ways of rehabilitating after proximal~     humerus fractures treated non-operatively.~   "
238120|NCT00438620|"~     Physical activity has been shown to have a positive effect on several quality of life~     outcomes in cancer patients, but few existing studies have focused on the end stages of~     cancer. The aim of this pilot study is to test the feasibility of a physical activity~     intervention in advanced cancer patients, from which data can be used to design a randomized~     controlled trial if results are encouraging.~   "
238732|NCT00430508|"~     The study will evaluate the blood pressure lowering effects of two different dosages of the~     combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high~     blood pressure.~   "
238121|NCT00438607|"~     The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is~     tolerated when given at different doses to patients with moderate to late-stage Parkinson's~     Disease who are also taking the Parkinson's medication, levodopa (L-DOPA).~      This study will also explore:~        1. the pharmacokinetics of BIIB014 in Parkinson's patients who are also taking L-DOPA (this~          will be done by measuring the levels of BIIB014 in the blood at several different times~          during the study), and~        2. the activity of BIIB014 when given to Parkinson's patients who are also taking L-DOPA~          (this will be done by performing different Parkinson's Disease assessments during the~          study to examine change in waking OFF time, change in time with troublesome dyskinesia,~          change in Unified PD Rating Scale (UPDRS) scores, and Clinical Global Improvement).~      Patients who enter this study will be randomly assigned to receive either BIIB014 or a~     placebo but because the study is blinded, neither they nor their study doctor will know which~     study treatment they are taking.~      The study will be divided into 2 parts:~        -  Part A: a, rapid, sequential cohort, dose escalation to establish MTD, followed by~        -  Part B: a parallel-group exploration of the two highest tolerated doses versus placebo.~      Note: As Part A of the study is now concluded, some of the study design information presented~     below (e.g., number of study arms) pertains only to Part B.~   "
238122|NCT00438594|"~     To examine the impact of prenatal and infancy home visiting by paraprofessionals and by~     nurses from child age 2 through 9.~   "
238123|NCT00438581|"~     This aim of this study to evaluate the safety and efficacy of combining a single course of~     Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with~     high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients~     with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.~   "
238124|NCT00438568|"~     The purpose of this study is to find out if insulin, when administered as a nasal spray~     into the nasal passages, improves memory in adults with mild cognitive impairment (MCI) or~     Alzheimer's disease.~   "
238125|NCT00438555|"~     Randomized, controlled, open, comparative intervention study in 270 children at risk for~     obesity.Patients will be randomly allocated into one of two behavior intervention groups or~     control group in ratio of 1:1:1.The study will consist of two main periods: an intervention~     period of 3 months followed by 21 months of a follow up period. During the intervention~     period, participants (parents or both parents and children, depending on randomization) will~     attend a behavior intervention program once a week, each session will last one hour and would~     be guided by dietician and psychologist. Follow up visits will be performed at the clinic~     (for participants in al 3 groups) at months 0, 3, 12 and 24.~   "
238126|NCT00438542|"~     Cross sectional, hospital-based study dealing with adiponectin levels in newborns to mothers~     with pre-eclampsia. Venus cord blood samples were collected immediately after birth; 30 cases~     and 62 controls were enrolled into the study. The study was approved by the local ethics~     committee and all participants gave written consent.~   "
238127|NCT00438516|"~     This project supports the post-third-grade assessment of 693 children and their families who~     were enrolled in a randomized trial of a program of prenatal and infancy home visitation by~     nurses that was epidemiologically and theoretically grounded. The project will determine~     whether the beneficial effects of the program on maternal, child, and family functioning~     extend through the early elementary school years, giving particular attention to maternal~     life-course and children's emerging antisocial behavior. Assessments of the children will be~     based on both mother and teacher reports. Teachers are independent, natural raters of the~     children's adaptation to an important social context. There are numerous reasons to expect~     that, from a developmental perspective, the effects of the program will increase as children~     experience the increased academic demands associated with entry into third grade. In~     addressing these questions, the current study will determine the extent to which this program~     of prenatal and infancy home visitation by nurses can produce enduring effects on maternal~     and child functioning (giving particular attention to the prevention of early-onset~     disruptive behavior disorders) in urban African Americans that are consistent with those~     achieved with whites in a central New York state county in a separate trial of this program~     conducted over the past 20 years.~   "
238128|NCT00438503|"~     The purposes are 1. to measure the effect of dialysis with glucose in dialysis water on blood~     pressure, pulse rate, plasma concentration of glucose, plasma concentrations og insulin,~     glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and 2. to~     analyse the relationship between the changes in blood pressure and changes in vasoactive~     hormones~   "
238129|NCT00438490|"~     Medications used to increase breast milk production increase prolactin secretion, the main~     hormone of lactation. There are no FDA approved medications used to improve breast feeding,~     but metoclopramide is used off-label and can have intolerable side effects. We examined the~     biological activity and safety of recombinant human prolactin (r-hPRL) as a potential~     medication to augment lactation. In this study, the effect of r-hPRL on breast milk~     production in women who did not recently deliver a baby and its effect on the bones and~     menstrual cycle were tested.~   "
238130|NCT00438477|"~     RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the~     nipple or near the tumor, may help doctors find out how far the disease has spread.~      PURPOSE: This clinical trial is studying two different injection methods to compare how well~     they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in~     patients with invasive breast cancer.~   "
238131|NCT00438464|"~     This randomized phase II trial studies how well finasteride works in treating patients with~     stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of~     prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by~     lowering the amount of testosterone the body makes. Giving finasteride before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
238132|NCT00438451|"~     In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older~     receive three different antiepileptic drugs in a double-blind, randomized design over a~     period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary~     endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy~     and tolerability.~   "
239442|NCT00421018|"~     The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to~     regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in~     patients with allergic asthma~   "
238133|NCT00438438|"~     The primary objectives of the proposed experimental and modeling efforts are to quantify the~     influences of acute sleep deprivation (short-term homeostatic), chronic sleep restriction~     (long-term homeostatic), circadian rhythmicity, and their interactions on neurocognitive~     performance and to develop a new model of sleep homeostasis that can predict the effects of~     chronic sleep restriction. This model will be based on the underlying neuroanatomy and~     neurophysiology. This new model will facilitate optimization of human performance in~     operational settings, such as are seen in military operation and other work environments.~   "
238134|NCT00438425|"~     The purpose of this trial is to re-evaluate the potential role of diet in modulating~     cardiovascular risk factors. If potent lipid-lowering effects through novel dietary~     interventions can be demonstrated, then diet may again be seen as providing an alternative to~     drug therapy in the primary prevention of cardiovascular disease.~      Aims:~        -  To determine the percentage of lipid clinic attendees interested in making a serious~          dietary change.~        -  To determine the extent to which a self selected dietary portfolio combining viscous~          fiber foods (oat & barley β-glucan, psyllium, etc.), soy and vegetable protein foods~          (soy milk, soy meat analogues and almonds) and plant sterols (sterol margarine) in the~          same diet be significantly more effective in reducing LDL-cholesterol and other markers~          of cardiovascular disease risk than conventional dietary advice.~        -  To determine whether this effect can be maximized by more frequent follow-up, and what,~          if any, would be the relationship between dietary compliance and reduction in LDL-C.~   "
238135|NCT00438412|"~     The mechanisms involved in development and maintenance of hypertension in obstructive sleep~     apnea are not clarified.~      We hypothesize that patients with obstructive sleep apnea have an abnormal level of some~     vasoactive hormones during apneic events during sleep.~   "
238136|NCT00438399|"~     The scalp is one of the most common affected sites in psoriatic patients as 79% of them have~     scalp involvement.It has also a psychological aspect with 31% of patients with scalp~     psoriasis indicating distress.~      Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not~     always ideal because they might be inconvenient and messy to use, stain or damage hair.~      The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the~     tradename of Clobex®) was developed to provide the strongest available corticosteroid as a~     short-contact therapy in order to improve the chances of it being effective and reduce the~     potential for traditional side-effects.~      The objective of this study is to compare subject's overall preference between Clobetasol~     propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate~     to severe scalp psoriasis.~   "
238137|NCT00438386|"~     The purpose of this study is to determine whether aripiprazole is effective in the treatment~     of refractory panic and generalized anxiety disorder.~   "
238138|NCT00438373|"~     The purpose of this study is to evaluate if there is an association between the serum LH~     receptor expression on the day of hCG administration or the day of oocyte retrieval and the~     retrieval rates at oocyte pick up~   "
238139|NCT00438360|"~     The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a~     day), when administered twice a week compared to continuous administration, in patients with~     chronic plaque psoriasis.~   "
238140|NCT00438347|"~     The purpose of this study is to examine the effect of aerobic fitness training on human~     cognition, brain structure, and brain function of older adults.~   "
238141|NCT00438334|"~     Directional microphone hearing aids have been shown to provide benefit for individuals with~     hearing loss in a number of laboratory experiments. However, few studies have investigated~     the real-world, subject-reported benefit from these hearing aids, and even fewer have~     examined directional hearing aid benefit across varying degrees of hearing loss. This study~     will summarize data from a three-year, multi-faceted study of directional hearing aid~     benefit. Ninety four subjects were divided into three hearing loss groups~     (normal-to-moderate, mild-to-moderately-severe, and moderate-to-profound). These subjects~     were then fit with experimental hearing aids set to either directional or omnidirectional~     mode to determine if significant differences were present in hearing aid outcomes (both~     subjective and objective). Both subject and experimenter were blinded to the hearing aid~     settings. Following one month of use in each experimental setting, subjects completed: probe~     microphone measurements, speech understanding in noise testing, use questionnaires,~     subjective benefit scales, and satisfaction scales. At the conclusion of the study, subjects~     rated their preferences for the experimental settings in quiet, noise and overall. Both~     objective measures, as well as subjective data, were analyzed across hearing aid and hearing~     loss conditions.~   "
238142|NCT00438321|"~     The purpose of the study is to examine the effect of testosterone treatment on insulin in men~     with the metabolic syndrome with testosterone levels at or below the lower end of the normal~     range.~   "
238143|NCT00438308|"~     The purpose of the study is to compare two common ways of rehabilitating after surgery for~     distal radius fractures treated operatively with a volar plate.~   "
238144|NCT00438295|"~     The purpose is to measure the effect of glucose in the dialysis water on blood pressure,~     pulse rate, and plasma glucose with and without body temperature control~   "
238145|NCT00438282|"~     To examine the impact of prenatal and infancy home visiting by paraprofessionals and by~     nurses from child age 2 through 6.~   "
238156|NCT00438139|"~     The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol~     (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety,~     pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and~     smoked marijuana to determine if there are potential significant interactions before~     conducting outpatient studies.~   "
238157|NCT00438126|"~     This is a randomized trial of an educational intervention to reduce the risk of diabetes~     among urban American Indian women~   "
238158|NCT00438113|"~     Atrial fibrillation (AF) is a very common arrhythmia causing many symptoms resulting in~     numerous hospitalizations. Catheter ablation is a technique that has evolved significantly to~     improve symptomatic recurrences, but does not offer a 100% cure rate. We hypothesize that the~     use of aggressive BP lowering will reduce the rate of recurrent AF after catheter ablation~     for AF. We plan a randomized clinical trial of aggressive BP lowering versus standard BP~     control to investigate this.~   "
238146|NCT00438269|"~     Infection developing in the intensive care unit is a common complication of critical illness,~     but notoriously difficult to diagnose. A definite diagnosis based on the most reliable tests~     usually is not possible for at least two days. It is unclear what the optimal management~     approach should be while awaiting the results of diagnostic tests. In some circumstances,~     broad spectrum antibiotics are started with a plan to adjust them once the results of~     cultures are available. Observational studies show that this results in greater antibiotic~     use, and the risk of superinfection and resistance. In other circumstances, antibiotics may~     be withheld pending the results of cultures, a strategy that leads to a delay in therapy when~     cultures are positive, and that may be associated with a worse clinical outcome.~      We undertook a randomized pilot study to address the question: In a critically ill patient~     for whom clinicians are uncertain whether infection may be present, and in whom potential~     sites of infection have been managed by removing or changing invasive devices, can a policy~     of delaying antibiotic treatment until cultures are available reduce the risks of excessive~     antibiotic use, without increasing the risks associated with delayed therapy?~      Recognizing that the question has not been formally addressed before, and that approaches to~     clinical management are both widely divergent and passionately held, our pilot study tested~     the feasibility and acceptability of undertaking a larger trial with sufficient power to~     determine equivalence.~   "
238147|NCT00438256|"~     A standard treatment for pancreatic cancer is radiation therapy plus chemotherapy after~     surgery. Radiation therapy and chemotherapy are commonly given for up to six weeks. Previous~     research has suggested that giving the radiation and chemotherapy for a shorter amount of~     time (accelerated schedule) before surgery may be better tolerated. In this research study,~     different schedules of proton radiation therapy will be used. Each schedule will give about~     the same total dose of radiation. However, the total dose will be spread out over different~     time periods and different numbers of sessions. The purpose is to find the shortest schedule~     of radiation therapy that can be given without unacceptable side effects. Proton beam~     radiation is being used because of its unique ability to deposit its energy directly in the~     tumor, resulting in less radiation to normal tissue. A new type of PET scan is also being~     studied to see if it can help predict the response to pre-surgery treatment.~   "
238148|NCT00438243|"~     This research is being done to look at the effects of Bromfenac, also called Xibrom for the~     treatment of swelling in the retina (the light sensitive tissue in the back of the eye)~     called macular edema that occurs after cataract surgery. Swelling in the retina can lead to~     blurry vision.~      The most commonly used treatment is eyedrops that decrease inflammation and may help stop~     some of the swelling. The investigators want to see if the drug Bromfenac(Xibrom) can~     decrease the swelling in the retina after cataract surgery and improve vision in these~     patients.~   "
238149|NCT00438230|"~     ABSTRACT Background The optimal duration of oral anticoagulant treatment in patients with~     idiopathic venous thromboembolism is still uncertain . The present study addressed the~     possible role of the Residual Vein Thrombosis in assessing the need for a prolonged~     anticoagulation.~      Methods Patients with a first episode of symptomatic unprovoked or provoked proximal Vein~     Thrombosis (VT) were given Oral Anticoagulant Treatment (OAT) for 3 months. Residual Vein~     Thrombosis (RVT), ultrasonographically-detected, will be then assessed. Patients without RVT~     did not continue OAT, whereas those with RVT will be randomized to either stop or continue~     OAT for 9 more months. Patients were followed-up prospectively focusing on the study~     outcomes: occurrence of recurrent venous thromboembolism and major bleeding over a period of~     at least 12 months after OAT discontinuation.~   "
238150|NCT00438217|"~     The goal of CPP-EDG 01 study is to assess possible genetic and/or environmental parameters~     which may influence the growth rate of children affected by precocious puberty. In this view,~     we are collecting clinical data and biological samples of children attended as outpatients at~     the Pediatric Endocrine Center of Pisa from 1998 to present (the study is still open). From~     biological (blood) samples, gene polymorphisms such as endocrine disruptor levels are~     determined and compared to different growth pattern of pediatric patients treated with~     different GnRH agonists.~   "
238151|NCT00438204|"~     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium and~     gemcitabine together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and gemcitabine~     together with bevacizumab works in treating patients with stage IIIB or stage IV non-small~     cell lung cancer.~   "
238152|NCT00438191|"~     DeQuervain's tenosynovitis is characterized by pain on the pain on the radial (thumb) side of~     the wrist problems with thumb function. At this point, the standard care is to change daily~     activities, use a thumb brace, and the possible use of painkillers. There is a difference in~     opinion among physical therapists about how to use the splint in the treatment of DeQuervain~     tenosynovitis. Some physicians tell patients to wear the brace at all times while other~     therapists encourage patients to exercise and use the brace as needed. Both approaches to~     using the splint are accepted as standard. The purpose of this study is to test and evaluate~     these two ways of splinting and assess which one is better for patients with DeQuervain~     tenosynovitis.~   "
238153|NCT00438178|"~     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow~     unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis~     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process~     of cell death that is often inhibited in cancer cells.~   "
238154|NCT00438165|"~     To examine the impact of prenatal and infancy home visiting by nurses from child age 2~     through 12.~   "
238155|NCT00438152|"~     This study will compare the benefit for patients switching from Kaletra® to Invirase® tablets~     over remaining on Kaletra® (based on randomization), to elicit the lipid benefits inferred in~     previous studies~   "
238159|NCT00438100|"~     To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary~     chemotherapy in patients with inoperable or recurrent breast cancer.~   "
238161|NCT00438074|"~     This study will investigate optical tissue characteristics as a function of neoadjuvant~     breast cancer treatment. Our objective in this pilot study will be to identify diffuse~     optical spectroscopy parameters that change with treatment and that may correlate with~     pathological response. The ultimate goal is to use such parameters ultrasound as an early~     predictor of pathological partial or complete response in women with locally advanced breast~     cancer receiving treatment with neoadjuvant treatments such as chemotherapy or neoadjuvant~     combined modality chemotherapy and radiotherapy.~   "
238162|NCT00438061|"~     Abdominal obesity is strongly associated with dyslipidemia, which may account for the~     associated increased risk of atherosclerosis and coronary disease. Weight reduction is~     suggested to be a preferred and effective first-line strategy to correct lipid abnormalities,~     particularly in overweight/obese subjects. This improvement may be related to the effect of~     reduction in abdominal fat mass on apoB and apoA-I metabolism, but this remains to be fully~     demonstrated.~      Hypothesis: Reduction in abdominal fat mass by weight loss decreases apoB concentration and~     raises HDL-cholesterol chiefly by increasing LDL-apoB fractional catabolic rate (FCR), as~     well as decreasing HDL apoA-I, respectively.~   "
238163|NCT00438048|"~     The purpose of this study is to assess and compare the safetyness and efficacy of pilocarpine~     drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by~     SS in a multicenter, doubleblind, controlled trial.~   "
238164|NCT00438035|"~     Postoperative pain stimulates the autonomic nervous system, induces the production of~     pro-inflammatory substances, reduces patient mobility and impairs vital functions. The ECG~     spectral analysis (ECGs) is a non-invasive marker of the autonomic nervous system state. To~     our knowledge, the correlation between the sympathovagal activity quantified by a non~     invasive method and the postoperative pain, has not been studied before.~   "
238165|NCT00438022|"~     Atopic Dermatitis (AD), also known as eczema, is a skin disease that causes the skin to be~     hot, dry and scaly, and have severe itching. There are different kinds of eczema. Eczema~     herpeticum (EH) is a type of eczema that spreads due to an underlying herpes virus infection.~     The purpose of this research study is to identify the risk factors that may cause EH.~   "
238166|NCT00438009|"~     The purpose of the study is to determine the safety and tolerability of two doses of~     Coxsackievirus A21, administered 48 hours apart into a superficial melanoma tumour.~      Injected and non-injected tumours will be observed regarding change in tumour size.~      Coxsackievirus A21 (CVA21) is a naturally occurring virus, that is known to cause self~     limiting upper respiratory infections. CVA21 has been shown in cell culture to infect and~     kill human melanoma cancer cell lines. This property of CVA21 is due to the specific~     receptors CVA21 uses in order to attach to, and infect a cell. The 2 receptors CVA21 uses to~     infect a cell are Intracellular Adhesion Molecule 1 (ICAM-1) and Decay Accelerating Factor.~     Both of these surface proteins are expressed on melanoma cell lines as well as human melanoma~     tumours. Animal models of human melanoma tumours have demonstrated that CVA21 injection~     either intratumour or intravenous causes infection in the tumours, resulting in reduction of~     tumour size and growth.~   "
238167|NCT00437996|"~     Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves~     analgesia and reduces the frequency of motor blockade during epidural analgesia. several side~     effects are possible mostly somnolence and hypotension. Association of continuous clonidine~     infusion with low concentrations of levobupivacaïne and sufentanil was not studied during~     labour. The objective of this study is to compare the effectiveness and the side effects of a~     PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of~     clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.~   "
238168|NCT00437983|"~     The primary objective of this trial is to assess the ability of an oral administration of~     Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo~     in age associated memory impaired subjects.~   "
238169|NCT00437970|"~     This study compares metformin (current first-line medication) to pioglitazone (a newer~     diabetic medication currently approved for combination use). Whilst there is good evidence~     for the benefits of pioglitazone use in other populations, in light of the known weight gain~     effects of pioglitazone we believe further assessment is required in Indigenous Australians~     (in whom there is a strong predisposition for central fat deposition). This study will~     provide evidence regarding the medication appropriate for first line medication in Type 2~     diabetes in this high risk population. This study will assist clinicians to make~     evidenced-based decisions regarding initial medical management of those with Type 2 diabetes~     (where there is currently a gap in evidence).~   "
238170|NCT00437957|"~     This type of study is called a Phase I study. Its purpose is to determine the side effects~     of the two medicines listed in this study when given together with whole brain radiation, and~     the highest dose of valproic acid that can be given together with temozolomide and whole~     brain radiation. We will also study the drug combination's effectiveness in treating cancer.~     While both of these drugs and whole brain radiation have been used in people for many years,~     they have never been combined for the purpose of treating patients with cancer.~   "
238171|NCT00437944|"~     The rational of the study is to try to predict which of the patients who suffer from Fabry~     disease will have End Stage Renal Disease. We hope to find correlation between certain~     modifier genes, previously related to renal disease, to renal disease in Fabry.~   "
238172|NCT00437931|"~     Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic~     changes.Regional blood flow disturbances (including intrathyroidal) were also reported in~     these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity~     and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid~     dysfunction~   "
238173|NCT00437918|"~     In type 2 diabetic patients, tight blood glucose control often requires both fasting and~     post-prandial glucose control separately. In the diabetic patients already on the insulin~     glargine treatment for the control of fasting blood glucose, additional measures for the~     control of post-prandial glucose level are often required. Nateglinide and acarbose are~     frequently used for this purpose. We hypothesized that the short acting sulfonylurea~     nateglinide may be more efficacious in diabetic patients with appreciable endogenous~     insulin secretion, while acarbose may be more efficacious in patients with lower endogenous~     insulin secretion. And we also want to clarify the clinical and biochemical parameters that~     can predict the responsiveness to each agent in this multi-center randomized open cross-over~     clinical study.~   "
238175|NCT00437892|"~     Elevated levels of D-dimer, a marker of procoagulant state, have been identified as a marker~     of an increased risk of recurrent VTE. Statins have proven antithrombotic properties, as~     suggested by the reduction of several prothrombotic markers, including D-dimer, in patients~     at high risk of arterial thrombosis. Such antithrombotic properties could also be observed in~     patients at high risk of venous thrombosis. Aim of the study is to assess the effect of~     statins on D-dimer levels in patients with previous VTE after oral anticoagulant treatment~     withdrawal.~   "
238176|NCT00437879|"~     We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently~     conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro,~     in situ and in vivo. The method can detect different forms of cell death and has been~     demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The objectives of~     this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive~     marker of advanced tumour response to combined chemotherapy and radiotherapy. Since~     neoadjuvant treatments may also act on tumour vasculature to normalize it we will also~     evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution~     imaging using clinically approved microbubble contrast agents.~      The main goal, as described above, is to select the best ultrasound spectroscopy parameter to~     use as an early predictor of pathological complete response.~   "
238177|NCT00437866|"~     Background: Anemia in chronic heart failure (CHF) is directly linked to increased mortality~     and reduced exercise capacity. The pathomechanism for the development of anemia in CHF is not~     well understood. Impairment of iron homeostasis is discussed to be one of the major triggers~     in anemia of chronic disease. Hepcidin was recently described as the central regulator of~     iron homeostasis.~      Main hypothesis: Plasma hepcidin levels are altered in anemic CHF patients compared to non~     anemic controls and might be a main contributing factor of anemia in CHF.~      Iron regulator-hypothesis High levels of cytokines in CHF patients cause up-regulation of~     hepcidin, which in turn leads to low iron uptake causing anemia. In this case venous hepcidin~     and hemoglobin concentrations should both correlate with cytokine levels.~      Erythropoietin regulator-hypothesis Dysregulation of the erythropoietin system results in~     anemia, which represses hepcidin. This leads to a negative correlation between hemoglobin and~     hepcidin in plasma.~      Methods: 100 consecutive patients diagnosed with systolic CHF will be prospectively included~     in the study. Iron status will be assessed and hepcidin, erythropoietin as well as~     interleukin-1, interleukin-6 and soluble TNF alpha receptor levels will be measured by ELISA.~      Patients will be followed up for one year and mortality, rehospitalization and worsening of~     CHF will be documented.~   "
238178|NCT00437853|"~     EFFICACY OF NEOADJUVANT ENDOCRINE THERAPY WITH ANASTROZOLE IN POMENOPAUSAL WOMEN WITH~     ER-POSITIVE BREAST CANCER.~      Flavia Morales-Vásquez, Horacio Noé López Basave.~      Background: Neoadjuvant Hormonal Therapy (HT) is being used increasingly to downstage locally~     advanced and large operable breast cancer. Following this treatment, inoperable breast cancer~     often becomes fully respectable and tumors requiring mastectomy may be successfully removed~     by breast-conserving surgery (BCS).~      Methods: Recruit postmenopausal women with ER(+) and/or PgR (+) breast cancer (BC) T2,N1-2 to~     T3,N0-1 were assigned to HT with anastrozole 1 mgr daily for 4 months.~      The primary endpoint was to compare overall objective response (OR) determined by clinical~     (palpation) and ultrasound. Secondary endpoint was the number of patients who qualified for~     BCS plus radiotherapy.~   "
238179|NCT00437840|"~     GSK598809 is being developed to facilitate overcoming an addiction to nicotine and to help~     people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people~     who smoke and will also look at blood levels of GSK598809 and nicotine.~   "
238180|NCT00437827|"~     This study is testing a process (rEEG)for selecting the most appropriate medication(s) to~     treat a patient's depression versus a control group being treated according to a standardized~     method, the modified Star*D Algorithm. Qualified subjects will be randomized to the~     experimental (rEEG guided) group, or the control group and treated for 12 weeks. Medications~     utilized in this study are currently marketed. All visits, physical exam, rEEG, labs, rating~     scales and medications are provided at no cost to the patient.~   "
238181|NCT00437814|"~     Objectives: Ketamine is an effective, short-acting anesthetic drug, which does not decrease~     blood pressure. It is widely stated that Ketamine increases intracranial pressure (ICP),~     which prevents its use in many emergency situations, specifically in patients with traumatic~     brain injury (TBI) and with increased ICP. Based on previous clinical experience, we~     hypothesized that Ketamine decreases – rather than increases – ICP.~      Methods: Prospective, controlled, clinical trial. Children with ICP monitoring will receive a~     single Ketamine dose (1-1.5 mg/kg) either for increased ICP and/or before a potentially~     distressing activity. Hemodynamic variables, ICP and cerebral perfusion pressure (CPP) will~     be recorded 1 minute before and every minute for 10 minutes following Ketamine administration~     (Before/after design).~   "
238182|NCT00437788|"~     Whenever a scan is accessed through the PACS system a scanned document or digital picture may~     be displayed automatically. In this study the technician will take a digital picture of the~     patient who will be undergoing the CT scan. This way the radiologist will be able to view the~     patient's face before viewing the scan.~      The hypothesis is that viewing a digital picture of the patient before viewing the CT scan~     will improve the quality of diagnosis.~   "
238183|NCT00437775|"~     Proteinuria is an expression of diabetic nephropaty in type 1 and type 2 patients.~     Hypertenshion treatment and decreasing urine protein excretion, slow down renal~     deterioration. Treating diabetic ,hypertensive patients with Angiotensin Converting Enzyme~     inhibitors (ACEi), Angiotensin receptor blockers (ARBs)is common practice. The aim of our~     work is to examine 1.The prevalence of ACE and ARB treatment in diabetic patients with or~     without hypertension.2. Adverse drug reactions of ACEi and ARBs alone or in combination.~   "
238184|NCT00437762|"~     Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we~     need more studies. The purpose of the study is to compare the effectiveness of botulinum~     toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical~     care performed during 6 months. Method : It is a double blind randomized controlled trial.~     Principal criteria of assessment is Pain intensity three months after injection.~   "
239445|NCT00420966|"~     The purpose of this study is to determine the utilization patterns and compliance rates of~     palivizumab, which is a monoclonal antibody therapy used to prevent respiratory syncytial~     virus infection.~   "
238185|NCT00437749|"~     Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of~     drugs with different mechanisms of action. Drug resistance remains a significant impediment~     to successful cancer chemotherapy inhibitors have been developed and are currently in~     clinical trials. CBT-1 is a natural product currently in clinical trials as an inhibitor~   "
238186|NCT00437736|"~     Two-centre, open label, uncontrolled, dose-finding phase I study, to determine the safety and~     tolerability of APO010 administered by intravenous bolus injection once per week. It will be~     the first time this agent will be administered to humans. At lower dose levels, the first~     cycle duration is 7 weeks. In subsequent cycles, APO010 is administered as 4 weekly doses~     followed by a two-week drug rest, cycle duration is 6 weeks. Based on preclinical studies of~     APO010 may cause liver toxicity and a drop in platelets, that recover within 5 days. The main~     aim of the study is to identify the recommended dose of APO010 for future clinical studies of~     APO010.~   "
238187|NCT00437723|"~     This 2 arm study will compare the level of anemia, and the decline in renal function, between~     patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney~     disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving~     NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of~     120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study~     treatment is 3-12 months, and the target sample size is <100 individuals.~   "
238188|NCT00437710|"~     We will study in a prospective randomised fashion 50 patients who will be treated by~     intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition~     to standard therapy after MI or standard therapy.~      After standard therapy for acute MI, 10 patients were transplanted with autologous~     mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon~     dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute~     MI were treated by standard therapy alone. After~   "
238189|NCT00437697|"~     Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary~     embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious~     complication. Optimal regimens for prevention of VTE have been established in medical~     patients only and are not known for ICU patients.~      It was therefore the aim of this study to compare the bioavailability of a low molecular~     weight heparin in ICU patients and in medical patients. Furthermore, we looked wether a 50%~     dose increase resulted in better bioavailability of this drug.~   "
238190|NCT00437684|"~     The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV~     drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN~     + ritonavir in HIV/HCV coinfected patients.~      Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with~     HIV efficacy versus optimized HAART.~   "
238191|NCT00437671|"~     The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when~     Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given~     concurrently with strict control on the anatomical location and timing of administration of~     TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate~     titer protection provided by TIG and TT given in combination will be assessed using a~     standardized administration regimen and standardized antibody assay procedure. This study may~     provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual~     coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage~     for anyone with the potential of developing tetanus.~   "
238192|NCT00437658|"~     This study is designed to see how a research compound (NBI-56418) works compared to DMPA-SC~     (also known as depo-provera) in women with endometriosis and to see how both may affect bone~     mineral density.~   "
238193|NCT00437645|"~     This study was designed to compare the efficacy, tolerability, and safety of the combination~     valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension~     not adequately controlled (defined as mean sitting systolic blood pressure [msSBP] ≥ 130 mmHg~     and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and~     tolerability of the treatments by providing data that assessed blood pressure and the~     proportion of patients developing peripheral edema.~   "
238194|NCT00437632|"~     GSK598809 is being developed as an innovative treatment for substance dependence and~     potentially other compulsive behavioral disorders. This study will evaluate the safety,~     tolerability and pharmacokinetics of repeat doses of GSK598809 in healthy volunteers.~   "
238195|NCT00437619|"~     This single arm study will evaluate the efficacy and safety of sequential treatment with~     Diavobet (betamethasone propionate 0.5mg/g plus calcipotriol hydrate 50 micrograms/g) once~     daily for 4 weeks followed by Daivonex (calcipotriol hydrate 50 micrograms/g) twice daily for~     4 weeks, in the control of signs and symptoms in patients with mild to moderate psoriasis.~     Only patients showing a >50% response to Daivobet will progress to the Daivonex maintenance~     phase. The anticipated time on study treatment is <3 months, and the target sample size is~     100-500 individuals.~   "
238196|NCT00437606|"~     This study will investigate the effect of hepatic impairment on the pharmacokinetics,~     pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients~     with mild and moderate hepatic impairment. Patients with type 2 diabetes, and with normal~     hepatic function, or mild or moderate hepatic impairment, will receive a single dose of GK~     Activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic~     and safety parameters. The anticipated time on study treatment is <3 months, and the target~     sample size is <100 individuals.~   "
238197|NCT00437593|"~     Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with~     diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane~     peeling with two different types of dyes.~   "
238198|NCT00437580|"~     This study aims to reduce the duration of VRE intestinal carriage by the administration of~     Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be~     assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks~     regimen with placebo.A stool culture will be performed every week for 5 weeks (during the~     administration of treatment) then every two weeks until 3 consecutive negative stool culture~     for VRE.~   "
239446|NCT00420953|"~     Determine the relative bioavailability of PM101 I.V. and Cordarone I.V.~   "
238199|NCT00437567|"~     Necrotizing enterocolitis (NEC) is the most common gastrointestinal catastrophe affecting~     10-15% of premature neonates of <1500 gm. NEC is a disease of the immature intestine,~     characterized by impaired mucosal barrier function leading to increased gut permeability. We~     have previously demonstrated a protective effect of probiotic administration against the~     development of NEC. Others have shown that prebiotics can stimulate natural production of~     bifidobacteria and lactobacillus in the preterm gut. We have therefore hypothesized that~     prophylactic administration of prebiotics would also provide protection against necrotizing~     enterocolitis in the premature neonate, without the potential for sepsis which has been~     reported on rare occasions with probiotics administration.~   "
238200|NCT00437554|"~     Primary:~      To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of~     glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared~     with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on~     HbA1c in patients with type 2 Diabetes Mellitus (DM)~      Secondary: To compare the following parameters in two treatment arm~        -  Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose (PP2h)~        -  Response rates in terms of HbA1c, FPG~        -  Patient compliance~      Safety:~        -  episodes of hypoglycemia~        -  adverse events~        -  laboratory values including hematology blood chemistry and urinalysis~        -  vital sign and physical examination~   "
238201|NCT00437541|"~     In six communities we will seek out households where someone who has a history of respiratory~     problems. For the first winter we will measure temperature and humidity of the house and~     health of occupants. We will insulate half the houses and the next winter compare them with~     the uninsulated houses to see if warmer houses improve health.~   "
238202|NCT00437528|"~     A novel sensor (a device named sensurine)was developed in the aim of real- time measurement~     of bladder volume. The sensurine device is a wearable, fully passive, non-invasive and~     compact heat flow sensor (patent pending) and electronic control unit. The device will serve~     as a tool for managing and treating bladder dysfunction (by behavioral treatment), such as~     overactive bladder without incontinence, urge incontinence and voiding difficulties. In this~     phase I of the clinical trial the sensor unit will be tested for technological feasibility~     demonstration and for collecting design data.~   "
238203|NCT00437502|"~     This study will evaluate the safety of administering a peptide vaccine consisting of twelve~     different tumor-rejection antigens known to be present on ovarian tumor cells. The vaccine is~     designed to elicit immune responses against twelve different pathways that are essential to~     tumor growth, survival and metastasis.HLA-A2+ is a required criteria for subject eligibility.~   "
238204|NCT00437489|"~     The primary objective of this study is to assess whether a simple initial dose prescription~     of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is~     non-inferior compared to the standard weight-based formula.~   "
238205|NCT00437476|"~     The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV~     drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN~     + ritonavir in patients naive for HIV and HCV.~      Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with~     HIV efficacy vs optimized HAART.~   "
238206|NCT00437463|"~     To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA~     nephropathy.~   "
238207|NCT00437450|"~     The purpose of this study is~        -  To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in~          patients with low risk myelodysplastic syndromes~        -  To evaluate the tolerance of this treatment~   "
238208|NCT00437437|"~     The purpose of this trial is to determine the effect of food versus a fasted state on~     single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate~   "
238209|NCT00437424|"~     The primary purpose of this protocol is to determine the effect of BMS-582664 on patients~     with hepatocellular carcinoma with varying levels of hepatic impairment~   "
238210|NCT00437411|"~     The investigators are studying whether a brief three-session mind-body workshop helps people~     with fibromyalgia. The investigators hypothesize that this workshop will significantly~     improve pain and other symptoms, compared to usual care.~   "
238211|NCT00437398|"~     The complex program of insulin replacement for type 1 diabetes that is current clinical~     standard of care is difficult to implement for long periods of time, associated with an~     increased risk of severe hypoglycemia and implemented by less than 50 % of the population of~     such patients. Outcomes of transplantation of isolated human islets have substantially~     improved and been performed at about 40 institutions around the world. We are proposing a~     clinical phase 1/phase 2 study of islet transplantation alone evaluating safety and efficacy~     in five patients with type 1 diabetes. Islet isolation from deceased donor pancreases will be~     performed at the Mayo Rochester Islet Isolation facility and islets infused by Interventional~     Radiology into the portal venous system. Following islet infusion, patients will be~     hospitalized for 48 hours in the General Clinical Research Center (GCRC) or at the Rochester~     Methodist Hospital. Multiple safety and efficacy outcomes will be followed on multiple~     occasions during the first year and periodically thereafter.~   "
238212|NCT00437385|"~     The purpose of this study is to evaluate three different continuation treatments after acute~     ECT concerning efficacy and impact on cognition in severly depressed patients.~   "
238213|NCT00437372|"~     This study is using the combination of radiation and antiangiogenic agents (agents that~     destroy existing blood vessels) seems to be an approach to tumor cure.~   "
238214|NCT00437359|"~     To investigate the benefit of postoperative adjuvant therapy using sequential administration~     of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in breast~     cancer.~   "
238233|NCT00437112|"~     A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a~     registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type~     2 diabetes who are currently taking oral medications and have not previously taken insulin.~     Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR~     Inhaled Insulin regimen.~   "
238247|NCT00436917|"~     RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast~     cancer.~      PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or~     osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA~     primary breast cancer.~   "
238215|NCT00437346|"~     Study title: Functional dyspepsia -- effect of acid reducing treatment and individualized~     information.~      Summary: 15-20% of all people experience dyspepsia each year. Dyspepsia means pain or~     discomfort in the upper part of the abdomen. Accompanying symptoms from the esophagus may be~     present. The most important relevant medical examination is gastroscopy, and if the findings~     are normal the condition is usually classified as functional dyspepsia.~      Several disturbances of function are now known as potential causes of such symptoms, and the~     optimal choice of treatment may vary.~      In the study the investigators plan to examine whether different types of functional~     disturbances respond differently to medical therapy. In particular, the investigators want to~     assess whether comprehensive and individualized information will influence the results of~     therapy. This has not been previously studied systematically.~      The investigators also postulate that disturbances of function of the esophagus may cause~     complaints that should be classified as functional dyspepsia even if the symptoms are~     atypical. Few studies have been done to evaluate this hypothesis, and there may be potential~     consequences for choice of appropriate treatment.~      In animal models and in humans is recently demonstrated that elevated gastric pH because of~     anti-ulcer treatment can trigger food allergy. We use a proton pump inhibitor in our study~     and eventually development of food allergy will influence patient's condition in an~     observations period. That why we're observing IgE dynamics in our study.~   "
238216|NCT00437333|"~     Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory~     patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the~     long-term metformin administration are know but no data are available on the effects after~     its suspension.~      The purpose of this study is to evaluate the effects of metformin suspension on insulin~     sensitivity in PCOS patients.~   "
238217|NCT00437320|"~     Skin photoaging or skin photodamage are terms used to describe the change in the structure,~     function and appearance of skin caused by prolonged and repeated exposure to sunlight or~     other ultraviolet light sources.~      The visible effects of skin photodamage are fine lines, skin sagging, skin roughness, liver~     spots and also the appearance of red patches made up of thin red vessels (called~     telangiectasia).~      More and more people are presenting to doctors with concerns about skin photodamage and the~     demand for corrective procedures is increasing.~      Metvix® photodynamic therapy (Metvix® PDT) is a procedure currently marketed in several~     countries in Europe (including the United Kingdom [UK] and Spain) and in Australia, for the~     treatment of benign forms of skin cancer (e.g. actinic keratosis).~      The aim of the study is to assess whether Metvix® PDT will be effective in correcting the~     effects related to photodamage and whether it will be well tolerated.~   "
238218|NCT00437307|"~     Determination of progression free survival after 12 months of FU~      Determination of total survival, response and quality of life~   "
238219|NCT00437294|"~     The purpose of this study is to determine whether the combination of enzastaurin and~     capecitabine is more effective than the combination of placebo and capecitabine in treating~     patients with breast cancer who were previously treated with an anthracycline and a taxane.~   "
238220|NCT00437281|"~     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of~     multiple doses of pregabalin in pediatric patients with partial onset seizures that are~     incompletely controlled on their current medications.~   "
238221|NCT00437268|"~     To see how well enzastaurin in combination with irinotecan and cetuximab works versus~     irinotecan and cetuximab in patients who have progressed within 3 months.~   "
238222|NCT00437255|"~     Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall~     Disease Severity and Investigator Global Assessment.~   "
238223|NCT00437242|"~     This study is being completed to demonstrate the lack of effect of repeat dosing with~     Odiparcil on the QTc interval.~   "
238224|NCT00437229|"~     GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study~     is designed to test the safety and the extent of the GW679769 affect on dexamethasone and~     ondansetron levels in humans.~   "
238225|NCT00437216|"~     Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on~     therapy to existing systemic or topical anti-psoriatic agents.~   "
238226|NCT00437203|"~     To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a~     chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of~     PF-00477736 that can be safely given in combination with gemcitabine. This is the first study~     of PF-00477736 in humans.~   "
238227|NCT00437190|"~     The purpose of this study is to establish the safety and effectiveness of the BRYAN(R)~     Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical~     spine.~   "
238228|NCT00437177|"~     OH dependence is associated with DA receptor changes. Both, the apomorphine test and the~     D2Rec SPECt are usefull for monitoring DA receptor status. We aimed at studying whether DA~     receptor hypofunction, assessed by means of the apomorphine test and the D2Rec SPECT, is a~     marker of relapse in detoxified OH dependents patients.~   "
238229|NCT00437164|"~     Many drugs used for the treatment of Type 2 Diabetes Mellitus cause the body to retain water.~     This study will assess whether or not GW677954 causes the body to retain fluid.~   "
238230|NCT00437151|"~     The primary objective of this study is to investigate potential differences in treatment~     adherence by teenagers among four interventions during treatment for acne.~   "
238231|NCT00437138|"~     Air pollution is a major cause of cardiovascular morbidity and mortality. The components of~     air pollution responsible and the mechanisms through which they might mediate these harmful~     effects remain only partially understood. We hypothesise that these adverse effects are~     mediated by combustion derived air pollutants and that even a brief exposure will effect~     heart and blood vessel function. We assess the effect of dilute diesel exhaust inhalation at~     levels encountered in urban road traffic on heart and blood vessel function in patients with~     stable coronary heart disease.~   "
238232|NCT00437125|"~     This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label~     fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.~   "
238955|NCT00427492|"~     Randomised doublet blinded study of the effect of tablet Magnesia (laxative) on post~     operative bowel ileus after open colonic resection. Material: 56 patients in two equal~     groups. Primary endpoint: Bowel function. Secondary endpoints: Intake of food and drinks.~   "
238234|NCT00437099|"~     Borderline Personality Disorder (BDP) is a serious mental disorder that affects about 1-2% of~     the general population, and it is characterized by severe psychosocial impairment and a high~     mortality rate due to suicide. Currently, the most effective treatments for BPD are~     psychotherapy (cognitive behavior therapy - CBT -) and pharmacotherapy (often as an important~     adjunctive role, especially for diminution of symptoms such as affective instability,~     impulsivity, psychotic-like symptoms and self-destructive behavior). Nevertheless, although~     several drugs are used in these patients, these drugs induce an improvement of some symptoms~     but do not cause the remission of BPD. Thus, identification of novel treatments is needed.~      The objective of this study is to examine the efficacy of Omacor® ( a mixture of omega-3-acid~     ethyl esters: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ) for BDP patients~     receiving CBT. Patients with BDP will be randomly allocated to the three arms of the study:~     1- CBT+placebo, 2- CBT+Omacor 1680 mg/d, 3- CBT+Omacor 3360 mg/d. Follow up will last for 12~     weeks. Assessment of affective symptoms, impulsivity and aggressivity will be carried out at~     baseline and at 2, 4, 6, 8, 10 and 12 weeks.~   "
238235|NCT00437086|"~     RATIONALE: Bortezomib may stop the growth of abnormal cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the abnormal cells.~      PURPOSE: This clinical trial is studying the side effects and how well bortezomib works in~     treating patients with advanced myeloproliferative disorders.~   "
238236|NCT00437073|"~     This study is for patients with ErbB2 overexpressing breast cancer that has spread to the~     brain and is still progressing there even after radiation treatment using WBRT (whole brain~     radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how~     safe and effective lapatinib is when given in combination with capecitabine to treat patients~     with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral~     drug that will be taken every day. Tests for safety and efficacy will be performed regularly~     during the course of the study.~   "
238237|NCT00437060|"~     This clinical trial is looking at brain function in young patients receiving methotrexate for~     acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate on brain~     function may help doctors plan cancer treatment.~   "
238238|NCT00437034|"~     This phase II trial is studying the side effects and how well aflibercept works in treating~     patients with stage II or stage III multiple myeloma that has relapsed or not responded to~     previous treatment. Aflibercept may be able to carry cancer-killing substances directly to~     multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood~     flow to the cancer.~   "
238239|NCT00437021|"~     The purpose of this study is to evaluate an investigational smallpox vaccine, called~     IMVAMUNE®, with respect to safety and immune (body's defense system) response. Participants~     will include healthy adults, age 18 or older born after 1971, who have not had smallpox~     vaccine before. Volunteers were originally assigned to 1 of 5 groups. In July 2007, a hold~     was placed on the Dryvax® groups and the study was modified. Volunteers, numbering 197, will~     be assigned by chance to one of 3 groups to be vaccinated twice with IMVAMUNE® vaccine or~     placebo (inactive substance) in Groups A and B, or to receive a single vaccination with~     IMVAMUNE® or placebo in Group F. Volunteers will complete a memory aid (diary) for 15 days~     following vaccination. Blood samples will be collected. Volunteers may participate for up to~     425 days.~   "
238240|NCT00437008|"~     The purpose of the study is to determine whether there are differences in postprandial~     endothelial function following a high-AGE(Advanced Glycation End-products) meal vs. a low-AGE~     meal. We also intend to investigate if the therapy with 1050mg Benfotiamine for 3 days~     protects against the postulated deterioration of endothelial function after a high-AGE meal~     in people with type 2 diabetes mellitus.~   "
238241|NCT00436995|"~     The purpose of this study is to assess the proportion of subjects sucessfully achieving a~     mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following~     extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.~   "
238242|NCT00436982|"~     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric~     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective~     randomized clinical trial.~   "
238243|NCT00436969|"~     A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to~     osteoarthritis.~   "
238244|NCT00436956|"~     Background:~        -  AZD2171 (Cediranib) is an experimental drug that inhibits formation of new blood~          vessels.~        -  Tumors need new blood vessels to grow. Preventing the growth of new blood vessels with~          AZD2171 may inhibit tumor growth.~      Objectives:~      -To determine the effectiveness and side effects of AZD2171 in patients with prostate cancer~     that has metastasized (spread beyond the primary site).~      Eligibility:~        -  Males 18 years of age and older with androgen-independent prostate cancer that has~          metastasized.~        -  Patients must have received prior treatment with docetaxel.~      Design:~      Patients take one AZD2171 by mouth every day in 28-day treatment cycles and undergo the~     following procedures:~        -  1- to 2-day hospitalization at the start of the study for biopsies and blood~          measurements to determine the level of AZD2171 in the bloodstream. Blood is drawn~          immediately before the first dose, and 0.25 hr, 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12~          hr, 24 hr, and 48 hours after the dose is taken.~        -  Blood tests before starting treatment and then monthly to determine the level of~          vascular endothelial growth factor receptor ( VEGFR), a protein involved in blood vessel~          formation.~        -  Magnetic resonance imaging (MRI) scans once a month to evaluate blood flow.~        -  Tumor biopsies (optional) both before and after the second and sixth treatment cycles.~        -  Clinic visits every 4 weeks, including various routine and research blood tests, urine~          test and electrocardiogram.~        -  Computed tomography (CT) scan of the chest, abdomen, and pelvis every 8 weeks~        -  Bone scan every 8 weeks~      Patients record all doses of AZD2171 taken or missed in a pill diary. They record their blood~     pressure at least once daily in a blood pressure diary.~      Treatment may continue as long as the patient tolerates the AZD2171 and the cancer does not~     worsen.~   "
238245|NCT00436943|"~     The researchers hypothesize that smoking cessation counseling improves with the~     implementation of a smoking status assessment data sheet in routine consults. This is a~     quality improvement study design to evaluate the impact of the implementation of a more~     formal smoking status evaluation in a resident/faculty driven outpatient clinic.~   "
238246|NCT00436930|"~     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body~     build an effective immune response to kill tumor cells. Colony-stimulating factors, such as~     GM-CSF, increase the number of white blood cells and platelets found in bone marrow or~     peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment~     for melanoma.~      PURPOSE: This randomized phase II trial is studying two different vaccine therapy regimens to~     compare how well they work when given together with GM-CSF in treating patients with~     recurrent or metastatic melanoma.~   "
238248|NCT00436904|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Giving~     alemtuzumab together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving alemtuzumab~     together with rituximab works in treating patients with high-risk, early-stage chronic~     lymphocytic leukemia.~   "
238249|NCT00436891|"~     Group A streptococcus (GAS) is a bacteria that causes many different sicknesses in children~     and adults. This study will look at the number of cases of pyoderma (bacterial skin~     infection) and scabies (skin mites that cause itching) in 550 infants 12 months or younger in~     Fiji. (GAS can cause pyoderma, and sometimes skin sites infested with scabies can become~     infected with GAS bacteria.) The study will also look at the makeup of GAS and how certain~     medications affect GAS. The infants will be involved in the study for approximately 1 week.~     Their skin will be examined for pyoderma and scabies. A swab sample will be taken from the~     pyoderma area to test for GAS. The researchers hope to see how often these skin infections~     occur and how they affect the Fijian population. The information will help the researchers to~     develop better treatment and possibly a vaccine to prevent infection. Infants with pyoderma~     that is defined as greater than mild will be referred for treatment.~   "
238250|NCT00436878|"~     The purpose of this study is to test the effects of large food portions on children's eating.~     Experiment 1 will test the effect of portion size on children's consumption of sweetened~     beverages; we hypothesize that serving large beverage portions will increase the amount of~     energy children consume from this food. Experiment 2 will test the effects of portion size on~     children's intake of fruits and vegetables (FV) affect intake whether such effects are~     moderated by children's FV preferences and; we hypothesize that serving large fruit and~     vegetable portions will produce increases in children's intake of these foods, particularly~     for children who like fruit and vegetables. Experiment 3 will evaluate how food energy~     density affects children's response to large portions; we hypothesize that large portions~     will have the greatest influence on children's energy consumption when foods are energy~     dense. Experiment 4 will begin to address perceptual mechanisms by which large portions~     affect children's eating.~   "
238251|NCT00436865|"~     The polycystic ovary syndrome is the leading cause of female infertility in the United~     States. The disorder affects approximately 6-10% of women of reproductive age. It is widely~     accepted that insulin resistance may be responsible for the infertility of this syndrome.~     Women are insulin resistant when their bodies do not respond to insulin's action to handle~     sugar as they normally should. Because of this insulin resistance, women with the polycystic~     ovary syndrome are also at high risk for developing type 2 diabetes. We have previously shown~     that D-chiro-inositol (DCI), a substance naturally found in our body that helps insulin's~     action, is lacking in women with the polycystic ovary syndrome. Not having enough DCI may~     lead to insulin resistance. The purpose of this study is to determine if weight loss helps to~     replenish the body with DCI and help to promote insulin's action.~   "
238252|NCT00436852|"~     This phase II trial is studying how well ABT-751 works in treating children with~     neuroblastoma that has relapsed or not responded to previous treatment. Drugs used in~     chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~   "
238253|NCT00436839|"~     To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and~     prednisone in subjects with hormone-refractory metastatic prostate cancer.~   "
238254|NCT00436826|"~     The goal of this study is to evaluate the safety, tolerability and effectiveness of oral~     cladribine when taken in combination with Interferon-beta (IFN-beta) therapy for the~     treatment of multiple sclerosis (MS).~      This study will randomize around 200 subjects from approximately 50 sites located world-wide,~     who have experienced at least one relapse while taking IFN-beta therapy within 48 weeks prior~     to Screening, irrespective of disability progression. Secondary progressive multiple~     sclerosis (SPMS) subjects, who are still experiencing relapses, and subjects who have~     received disease modifying drugs (DMDs), other than IFN-beta therapy, during their MS~     treatment history, but are currently on IFN-beta therapy and have experienced active MS~     symptoms (at least 1 relapse) during the 48 weeks prior to Screening, may also be enrolled.~      Subjects will be randomized in a 2:1 fashion to receive up to 4 cycles of oral cladribine or~     matching placebo in combination with IFN-beta therapy. Subjects who complete the double-blind~     portion of the study will be invited to participate in an open-label extension phase of~     matching study design. Total participation is 96 weeks in double blind period, and up to 48~     weeks in open label extension phase.~   "
238255|NCT00436800|"~     Primary objective:~      To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in~     the first line treatment of metastatic or recurrent nasopharyngeal carcinoma.~      Secondary objectives:~      To assess the toxicity, duration of response, time to progression, progression-free survival,~     overall survival and cancer-related symptoms in the first line treatment of patients with~     metastatic or recurrent NPC.~   "
238256|NCT00436787|"~     Morbidly obese individuals are at high risk for potentially life threatening blood clots~     around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA-~     approved medication used in the prevention of deep venous thrombosis (DVT) at the time of~     orthopedic or abdominal surgery, as well as for the treatment of DVT and pulmonary embolism~     (PE). As with many medications, therapeutic dosages have not been fully investigated for the~     morbidly obese population. Our goal is to study the therapeutic blood levels, after 2~     different dosages of the medication are given to morbidly obese volunteers. We will recruit~     21 morbidly obese (Body Mass Index (BMI) > 35) individuals who are in the evaluation process~     for bariatric surgery. They will be divided into 7 groups: 3 participants with BMI 35 - 39.9,~     3 with a BMI of 40 - 49.9, 3 with a BMI of 50 - 59.9, 3 with a BMI > 60, 3 with a weight of~     100 - 149 KG, 3 with a weight of 150 - 199 KG and 3 with a weight of 200 - 249 KG.~     Participants will be administered two different doses of the medication with a 2-week~     interval in between, then blood will be drawn in various intervals throughout the next 48~     hours to see which dose provides the best therapeutic levels. Participants will be monitored~     closely for any side effects or complications.~   "
240272|NCT00409955|"~     - The goals of this study are to develop a lyophilization method for anterior lamellar~     transplants in Brasil and to make a comparative analysis among patients transplanted with~     lyophilized and optisol corneas~   "
238257|NCT00436774|"~     RATIONALE: Treatment for pediatric extracranial germ cell tumors may cause side effects and~     secondary cancers later in life. A study that evaluates patients after receiving combination~     chemotherapy or surgery may help doctors understand the side effects and secondary cancers~     that occur later in life.~      PURPOSE: This study is looking at treatment outcome and quality of life in patients with~     pediatric extracranial germ cell tumors previously treated on clinical trial CCLG-GC-1979-01~     or CCLG-GC-1989-01.~   "
238258|NCT00436761|"~     RATIONALE: Giving chemotherapy before a donor umbilical cord blood stem cell transplant helps~     stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting~     the donor's stem cells when they do not exactly match the patient's blood. The donated stem~     cells may replace the patient's immune cells and help destroy any remaining tumor cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving cyclosporine and methylprednisolone~     after the transplant may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects of busulfan, melphalan, and~     antithymocyte globulin followed by umbilical cord blood transplant in treating young patients~     with refractory or relapsed malignant solid tumors.~   "
238259|NCT00436748|"~     The primary objectives of this study are the following:~        1. To test if the proportion of participants achieving a hemoglobin value greater than or~          equal to 10.0 g/dL at any time point after the first dose during the study is greater~          than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of~          anemia in pediatric patients with chronic kidney disease receiving and not receiving~          dialysis, and~        2. To test if the proportion of participants achieving a hemoglobin value greater than or~          equal to 10.0 g/dL at any time point after the first dose during the study is greater~          than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of~          anemia in pediatric patients with chronic kidney disease receiving and not receiving~          dialysis.~   "
238260|NCT00436722|"~     This is a randomized, controlled trial in liver transplantation in which conventional~     immunosuppressive treatment will be compared with a therapeutic strategy consisting in~     pre-transplant antibody-mediated T cell depletion followed by reduced calcineurin inhibitor~     usage. The working hypothesis is that antibody induction followed by calcineurin inhibitor~     minimization may promote development of tolerogenic mechanisms allowing the eventual~     withdrawal of all immunosuppressive therapy.~   "
238261|NCT00436709|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such~     as doxorubicin, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving bevacizumab together with chemotherapy after surgery may~     kill any tumor cells that remain after surgery.~      PURPOSE: This clinical trial is studying the side effects and how well giving bevacizumab~     together with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized~     nanoparticle formulation and bevacizumab works in treating patients who have undergone~     surgery for early-stage breast cancer.~   "
238262|NCT00436696|"~     RATIONALE: Identifying genes related to cancer may help in the study of cancer. It may also~     help doctors predict who is at risk of developing neuroblastoma.~      PURPOSE: This laboratory study is looking at genes in participants with neuroblastoma or~     noncancerous conditions.~   "
238263|NCT00436683|"~     Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food,~     reducing the amount that the body can absorb.~      The purpose of this study is to determine how well a range of different doses of fermagate~     are tolerated by the subjects in the trial.~   "
238264|NCT00436670|"~     A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317~     compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom~     scores from baseline to week 12.~   "
238265|NCT00436657|"~     There has been no successful treatment of diffuse peritoneal metastasis or carcinomatosis, in~     childhood tumors. Once this advanced stage of disease is evident, survival is measured in~     weeks. The selective lethal effect of supranormal temperatures on neoplastic cells and the~     additive or synergistic effect of combining chemotherapy has been well established in adult~     clinical trials using continuous hyperthermic peritoneal perfusion (CHPP) for advanced~     peritoneal adenocarcinoma of gastrointestinal origin, ovarian carcinoma and mesothelioma.~      This phase I study will evaluate the safety of continuous hyperthermic peritoneal perfusion~     with escalating doses of intraperitoneal cisplatin in the treatment of children with~     refractory tumors limited to the abdominal cavity. If tumors are outside the abdominal~     cavity, the tumors must be able to be controlled.~      Since CHPP has potential to improve outcome of children with peritoneal and retroperitoneal~     metastases, this study will evaluate the safety of elevated temperature (40oC) with~     intraperitoneal cisplatin chemotherapy.~      Primary Objectives:~        1. To determine the MTD and dose-limiting toxicity of intraperitoneal cisplatin given in~          combination with CHPP as a 90 minute perfusion in children with advanced peritoneal and~          retroperitoneal solid tumors~        2. To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II~          trials~        3. To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP~          as a 90 minute abdominal perfusion (Optional)~   "
238266|NCT00436644|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving lapatinib together with topotecan may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving lapatinib together with topotecan~     works in treating patients with ovarian epithelial cancer or primary peritoneal cancer that~     did not respond to cisplatin or carboplatin.~   "
238267|NCT00436631|"~     This is a prospective, open-label (no control or blind) study to continue to determine~     whether the modified Atkins diet reduces seizures, creates ketosis, and is well tolerated in~     adults (not children) with epilepsy. This study will enroll and manage patients via email,~     phone, and fax and without dietitian involvement (primary difference from previous studies).~     It is a 3 month study.~   "
238268|NCT00436618|"~     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the cancer.~      PURPOSE: This phase II trial is studying the side effects and how well everolimus works in~     treating patients with lymphoma that has relapsed or not responded to previous treatment.~   "
238269|NCT00436605|"~     This phase II trial is studying how well dasatinib works in treating patients with stage III~     melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
238270|NCT00436592|"~     The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter~     in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours~     prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and~     potentially reduce the damage caused by stroke.~   "
238271|NCT00436579|"~     This randomized phase I trial is studying the side effects, such as high blood pressure, and~     best dose of sorafenib in treating patients with advanced solid tumors. Sorafenib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the tumor.~   "
238272|NCT00436566|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     combination chemotherapy together with trastuzumab and lapatinib after surgery may kill any~     tumor cells that remain after surgery.~      PURPOSE: This randomized phase II trial is studying the side effects and how well giving~     doxorubicin together with cyclophosphamide followed by trastuzumab, paclitaxel, and lapatinib~     works in treating patients with early-stage HER2-positive breast cancer that has been removed~     by surgery.~   "
238273|NCT00436553|"~     This study evaluated the effect of combination therapy with verteporfin photodynamic therapy~     and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy~     and the durability of response observed in patients with choroidal neovascularization~     secondary to age-related macular degeneration.~   "
238274|NCT00436540|"~     The primary objective of this study is to evaluate the efficacy and safety of clobetasol~     propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.~   "
238275|NCT00436527|"~     This eight-hour kinetic regression clinical study was conducted to assess the ability of~     MetroGel® 1% to deliver moisture to facial skin after a single application.~   "
238276|NCT00436514|"~     Colorectal cancer is one of the most frequent and it prognosis is still serious. In France,~     diagnosis and screening applicated in numerous departements, and now in a path of~     generalization to the all country, is based on combination of searching blood into bowel~     movements (Haemoccult) for the screening of population with medium risk (age between 50 to 74~     years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the~     patients with a high risk.Even if the efficiency of this strategy is proved, searching blood~     into the bowel movement by Haemoccult is still imperfect (a lot of false negative).~     Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and~     it constitute an invasive method, with complications, with a compulsory general anesthesia,~     implicating a high cost. The alternative of a screening method based on a non invasive method~     is required.~   "
238277|NCT00436501|"~     This phase I/II trial is studying the side effects and best dose of VEGF Trap when given~     together with docetaxel and to see how well they work in treating patients with persistent or~     recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.~     VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used~     in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving VEGF Trap together with~     docetaxel may kill more tumor cells~   "
238278|NCT00436488|"~     The genetic contribution to the development of obesity is now well recognized. However~     obesity is a polygenic disease and thus many genes are likely to be involved. This study aims~     to investigate the possible association between specific variants of the gene coding for the~     Intercellular Adhesion Molecule-1 (ICAM-1)and the development of severe obesity in an Italian~     population~   "
238279|NCT00436475|"~     The purpose of the randomized trial is to quantify the effect of vitamin D and calcium~     supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic~     inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2~     diabetes.~   "
238280|NCT00436462|"~     Expression of steroid receptors in endometrium during ovarian stimulation.~   "
238281|NCT00436449|"~     This will be a multi-centre, double-blind, within-subject, placebo controlled randomised~     trial in female subjects. All subjects will undergo bilateral breast augmentation surgery.~     Immediately following surgery, each subject will receive 100µl containing 50ng or 200ng of~     RN1001 per linear centimetre intradermally into both margins of one breast wound, and 100µl~     of placebo solution per linear centimetre intradermally into both margins of their other~     breast wound. The allocation of treatment to wound (left or right) will be randomised and~     double blind.~   "
238282|NCT00436436|"~     RATIONALE: Drugs used in chemotherapy, such as O(6)-benzylguanine and temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving~     O(6)-benzylguanine together with temozolomide works in treating patients with glioblastoma~     multiforme that did not respond to previous temozolomide and radiation therapy.~   "
238283|NCT00436423|"~     The primary objective of the study is to Evaluate the response rate of Gemcitabine with TS-1~     in Korean patient with advanced but inoperable, metastatic or recurrent pancreatic cancer who~     is not receiving anti cancer therapy.~   "
239839|NCT00415792|"~     hCG and GnRH agonist can be used to induce final oocyte maturation and ovulation in IVF~     cycles. These two approaches will be compared in this study in terms of pregnancy rates and~     embryological data using patients with hyper-response to IVF drugs.~   "
238284|NCT00436410|"~     RATIONALE: Biological therapies, such as tumor necrosis factor, may stimulate the immune~     system in different ways and stop tumor cells from growing. Studying tumor necrosis factor in~     samples of tumor tissue and healthy tissue from patients with cancer in the laboratory may~     help doctors learn how tumor necrosis factor works in tumor tissue and healthy tissue.~      PURPOSE: This clinical trial is studying tumor necrosis factor in patients undergoing surgery~     for primary cancer or metastatic cancer .~   "
238285|NCT00436397|"~     RATIONALE: A new radiation therapy planning system may help doctors plan better treatment for~     patients with cancer.~      PURPOSE: This clinical trial is studying a new radiation therapy planning system in patients~     undergoing radiation therapy for extracranial cancer.~   "
238286|NCT00436384|"~     Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a~     transplant. Serious infections due to CMV can affect many parts of the body including the~     lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have~     evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or~     valganciclovir). Despite this, there are a chance that CMV infection may cause problems in~     the future. The purpose of this study is to assess how well patients'immune systems responds~     to the CMV virus, so that in the future it may be possible to predict which patients are at~     highest risk of CMV.~   "
238287|NCT00436371|"~     To collect the safety and response of using Amisulpride in acute schizophrenic patients~   "
238288|NCT00436358|"~     This is an epidemiology study designed to implement hospital-based active surveillance for~     intussusception (IS) in children <1 year of age and lower respiratory tract infection~     (LRTI)-related deaths among children between 29 days and 1 year of age in Mexico. An existing~     linked database of the Instituto Mexicano del Seguro Social (IMSS) will be used. The study~     described in this protocol is a pilot study, which will evaluate the methodology to be used~     in a later Post-Marketing Surveillance (PMS) study.~      The planned epidemiology study will be conducted in IMSS hospitals and potentially use the~     IMSS database to re-capture potential cases of IS and fatal cases and as a source of matched~     case controls. The purpose of this project is to complement this data link system with an~     active surveillance system for IS - in order to assess the feasibility of using the IMSS data~     system by generating results that provide scientific validity. Such comprehensive (passive~     and active) surveillance systems will facilitate the post licensure safety profile evaluation~     of vaccines such as a vaccine against rotavirus diarrhoea.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
238289|NCT00436345|"~     This study will be a multicentre randomized, open-label, phase IIIb study. This study will~     evaluate two different techniques of sedation: an analgesia based regimen with remifentanil~     versus a conventional sedation based regimen using propofol in subjects that require~     mechanical ventilation for at least 2 days in the ICU. The conventional sedation based~     regimen will consist of propofol combined with an opioid according to routine clinical~     practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen~     will consist of remifentanil, with propofol added on if required.~   "
238290|NCT00436332|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with~     bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab~     works in treating patients with stage III or stage IV non-small cell lung cancer.~   "
238291|NCT00436319|"~     The purpose of this study is to assess whether the probability of pregnancy is dependent on~     the duration of GnRH agonist downregulation in IVF cycles.~   "
238292|NCT00436306|"~     The primary purpose of Project PROTECT was to evaluate two different intervention approaches~     that encourage young women to use dual methods of contraception. The individualized~     intervention is a computer assisted, fully-tailored, interactive intervention based on the~     transtheoretical model of behavior change. This intervention was compared to an enhanced~     standard care intervention that provided computer-based, non-tailored information and advice~     regarding the use of contraceptive methods. The two primary outcomes of this trial include:~     1) a behavioral outcome: the reported use of dual methods of contraception; and 2) a~     biological outcome: an incident or recurrent STI or unintended pregnancy. The hypotheses of~     this trial were: 1) the individualized intervention will result in a greater increase in dual~     contraceptive use than the standard care approach; and 2) the individualized intervention~     would result in greater protection against incident or recurrent cases of sexually~     transmitted infections and unplanned pregnancies.~   "
238293|NCT00436293|"~     Primary objective:~      To assess and compare the toxicities of patients with advanced NPC treated with concurrent~     cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.~      Secondary objective:~      To assess tumor control and survival~   "
238294|NCT00436280|"~     The primary purpose of this study is to help answer the following research questions:~        -  To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin~          (R-GEMOX) can help patients with Diffuse Large B-Cell Lymphoma remain free from disease~          and thus live longer.~        -  To assess for any side effects that might be associated with enzastaurin and R-GEMOX .~        -  To look at the characteristics and levels of certain genes and proteins to learn more~          about DLBCL and how enzastaurin works in the body.~        -  To look at the level of enzastaurin in the body and how long it remains.~   "
238295|NCT00436267|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in~     chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving radiation therapy in~     different ways and giving it together with chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving internal~     radiation therapy and external radiation therapy together with fluorouracil works in treating~     patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot~     be removed by surgery.~   "
238296|NCT00436254|"~     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.~     Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in~     bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an~     effective treatment for breast cancer and ovarian cancer. PURPOSE: This phase I trial is~     studying the side effects and identifying the best dose of vaccine therapy when given~     together with sargramostim in treating patients with stage III-IV breast cancer or ovarian~     cancer.~   "
238297|NCT00436241|"~     This single arm study will assess the efficacy and safety of Xeloda in combination with~     oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric~     cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible~     patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days~     treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks.~     The anticipated time on study treatment is until disease progression, and the target sample~     size is <100 individuals.~   "
238298|NCT00436228|"~     SB-742510 is a semi-synthetic pleuromutilin antibiotic that is being developed for treatment~     of respiratory infections.~      The purpose of this study is to estimate the bioavailability of four different formulations~     and to evaluate the safety of each of the four formulations~   "
238299|NCT00436215|"~     Background:~        -  Sorafenib and bevacizumab are anti-cancer drugs that work by targeting the blood vessels~          that allow tumors to grow. Using the two drugs together may more effectively block the~          formation of blood vessels that feed tumors.~        -  Sorafenib and bevacizumab both are approved by the Food and Drug Administration for use~          in other cancers but have not ovarian cancer. In a preliminary trial of this drug~          combination, however, tumors in 6 of 14 patients with ovarian cancer shrank.~      Objectives:~        -  To determine the safety and activity of the combination of sorafenib and bevacizumab for~          treating patients with ovarian, fallopian and peritoneal cancer.~        -  To determine how sorafenib and bevacizumab may affect the cancer by measuring amounts of~          different proteins in small biopsy samples of tumor taken before starting treatment and~          after 6 weeks.~      Eligibility:~        -  Females 18 years of age and older with ovarian, fallopian, or peritoneal cancer whose~          disease has not responded to standard treatment or for which no standard treatment is~          available.~        -  Patients must have not been previously treated with bevacizumab or must have had their~          disease worsen while taking bevacizumab-based therapy.~      Design:~        -  Patients take 200 mg of sorafenib by mouth twice a day Monday through Friday each week~          and 5 mg/kg of bevacizumab through a vein every 2 weeks.~        -  Tumor biopsies and imaging scans (magnetic resonance imaging (MRI) and positron emission~          tomography (PET) are done before treatment, 3 days after beginning treatment, and 6~          weeks into therapy.~        -  Computed tomography (CT) or other imaging tests are done every 8 weeks to evaluate~          response to treatment.~        -  History, physical examinations, blood and urine tests are done periodically during~          treatment for health checks and research purposes.~        -  About 74 patients are to be enrolled in the trial.~   "
238300|NCT00436202|"~     The purpose of the study is to determine whether improvement in the accessibility to iron~     supplement will decrease anemia rates in infants.~   "
238301|NCT00436189|"~     Purpose~      The OvaRI assay clinical trial is directed at evaluating a novel proteomics-based blood test.~     This test is for a physician to use towards differentiating benign from malignant ovarian~     tumors prior to surgical intervention. Tools that can better triage women with an ovarian~     tumor are needed. It has been shown that women with ovarian cancer who are referred to~     gynecologic oncologists have better outcomes. The primary objective of this study is to~     demonstrate that the OvaRl assay (test) improves the preoperative identification of ovarian~     cancer in patients with a ovarian tumor.~   "
238302|NCT00436176|"~     The goal of this study is to investigate methods of improving diabetes care for African~     Americans in primary care clinics. Primary care clinicians will receive training in the~     delivery of cross-cultural medicine as well as regular performance feedback reports.~   "
238303|NCT00436163|"~     This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in~     treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive~     chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180~     micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a~     24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12~     months, and the target sample size is less than 100 participants.~   "
238304|NCT00436150|"~     This study will aim to prevent postpartum depression in pregnant teenagers through an~     interpersonal therapy-based program.~   "
238305|NCT00436137|"~     The purpose of this study is to determine whether direct mailings to patients with positive~     fecal occult blood tests can increase rates of performing followup colonoscopy.~   "
238306|NCT00436124|"~     This study will evaluate the efficacy and safety of Tamiflu in patients with~     clinically-diagnosed influenza occurring during an influenza outbreak within the community.~     Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs~     and antibiotics) or support therapy alone. The anticipated time on study treatment is <3~     months, and the target sample size is <100 individuals.~   "
238307|NCT00436111|"~     The purpose of this study is to clarify the nature of macroprolactin which has recently been~     highlighted because of the high prevalence and a diagnostic pitfall of hyperprolactinemia.~     The results of this study are beneficial for the patients to whom unnecessary medications and~     unnecessary radiological examinations have been performed.~      We used the remained serum samples taken for routine prolactin determination during the past~     several years. Since the blood was basically taken to examine the causes of~     hyperprolactinemia and only remained serum samples were used for this study, the Ethics~     Committee of Kobe City General Hospital judged that it was not required to obtain approval~     number.~   "
238308|NCT00436098|"~     Children with congenital heart defects have shown to develop motor coordinative deficiencies.~     In this study we want to show that a motor pedagogic physical training can improve the~     coordinative capabilities of children aged 4-6 years.~   "
238321|NCT00435929|"~     This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics~     of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir~     1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly~     with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a~     group of HIV patients without known liver disease and a group with moderate liver disease.~     The anticipated time on study treatment is <3 months, and the target sample size is <100~     individuals.~   "
238322|NCT00435916|"~     This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective~     response rate and assess toxicity in patients with relapsed DLBCL.~   "
238983|NCT00427128|"~     This study randomized two stratifications of acute phase MDD SSRI responders, categorized as~     having either true drug response or placebo response pattern, to continuation with SSRI~     vs placebo in a double-blind trial to determine if stratification category predicted~     continuation outcome.~   "
238309|NCT00436085|"~     The introduction of highly active antiretroviral therapy (HAART) has dramatically changed the~     consequences of an HIV infection, which is now viewed as a chronic disease. As in other~     chronic diseases, emotional distress and depressive symptoms are highly prevalent in~     HIV-infected patients. Psychological factors such as these have been associated with lower~     quality of life, lower adherence to therapy and also with a higher risk for mortality and~     disease progression. Psychosocial interventions, such as group-based cognitive behavioral~     stress management (CBSM) training, have been shown to reduce distress and psychological~     symptoms in HIV-infected patients. These psychosocial effects are paralleled by changes in~     physiological parameters, such as cortisol, DHEA-S, testosterones, catecholamines, and naïve~     T-cell counts. While these results are congruent with recent evidence of the interaction~     between psychological, neuroendocrine and immunological parameters in HIV-infected patients,~     it needs to be shown whether the reported effects hold true in the HAART era. Most~     importantly, it also needs to be ascertained whether these interventions have an impact on~     immunological and virological HIV parameters as well as on mortality and morbidity in HIV~     patients. We propose a randomized controlled one-year prospective evaluation of a group-based~     CBSM training in 80 HIV-infected patients. Participating patients will be recruited at~     cooperating centers of the Swiss HIV Cohort Study and randomly assigned to CBSM training or~     waiting control group condition. At baseline, post-training and two follow-up (6 and 12~     months) assessments, effects of the CBSM on psychological, physiological and clinical~     out-come variables in HIV-infected patients under HAART will be evaluated. Additionally, the~     effects of CBSM on the neuroendocrine and autonomic stress reactivity in HIV-infected~     patients will be assessed, thus evaluating a possible direct pathway between emotional~     distress and physiological HIV-relevant parameters. In conclusion, the planned research~     project evaluates the effectiveness of a standardized psychosocial intervention as a possible~     component of a comprehensive disease management in HIV-infected patients under HAART.~   "
238310|NCT00436072|"~     This research study will test the safety of the investigational drug, ZD6474, in combination~     with 2 other drugs that are standard in the treatment of colon and rectal cancer (cetuximab~     and irinotecan). ZD6474 blocks the action of two substances in the body: vascular endothelial~     growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR). VEGFR stimulates~     the formation of new blood vessels. When cancer cells produce VEGFR, new blood vessels are~     made that provide blood to the cancer cells. The blood carries nutrients and oxygen, allowing~     the cancer cells to live and grow. EGFR controls how quickly cells grow and multiply. Both of~     these substances are found on normal cells, but they are found in much higher levels on~     cancer cells.~   "
238311|NCT00436059|"~     The primary objective of the the study is to investigate the changes in bone remodeling~     during Velcade treatment.~   "
238312|NCT00436046|"~     Influenza is a virus infection that causes sickness from the nose to the lungs. It is thought~     that type 1 interferon (a protein that helps the immune system fight viruses) will make flu~     vaccines more effective. This study will determine if type 1 interferon added to a specific~     flu vaccine will help the immune system of healthy adults fight off infection better than~     vaccine alone. Ninety volunteers, ages 18-40, will participate in this study. They will~     attend 3 study visits and have a final follow-up study visit, email, or phone call about six~     months after the vaccination. Volunteers will receive a single dose of study vaccine sprayed~     into the nose. Study procedures including blood samples and nasal washes (the inside of the~     nose is washed out) will be collected to evaluate immune system responses.~   "
238313|NCT00436033|"~     Investigation of efficacy and safety of treatment with milnacipran in the treatment of~     fibromyalgia syndrome.~   "
238314|NCT00436020|"~     Bipolar affective disorder (BPAD) is:~        -  A serious mental illness~        -  Estimated to be present in as high as 6.4% of the population in Western populations~        -  Associated with considerable disability and high morbidity.~        -  Characterized by periods of both lowered and elevated mood (i.e. depression and~          mania/hypomania respectively).~      The depressive aspect of bipolar disorder is often overlooked, possibly due to its less~     dramatic nature, despite its significant impact on the lives of those affected. Bipolar~     depression (BPAD-DP) is associated with a twenty fold increased risk of suicide, and~     typically lasts three to five times as long as a manic or hypomanic episode. Despite this,~     there has been relatively sparse investigation of treatments for BPAD-DP, with guidelines~     based primarily on expert judgment rather than clinical trials. In addition a significant~     proportion of patients with bipolar depression do not respond to the range of commonly used~     medications. One of the only substantially new treatments developed for unipolar depression~     in recent years has been the advent of repetitive transcranial magnetic stimulation (rTMS).~     Repetitive TMS has been evaluated in over 20 trials conducted over the last ten years, but no~     substantive trials have explored its use in bipolar depression. We propose to do this,~     conducting a large scale clinical trial. The trial will include the assessment of both high~     frequency left sided rTMS (as there is clearly the greatest evidence for the effectiveness of~     this in unipolar depression) and low frequency right sided rTMS (as this there is growing~     evidence of the effectiveness of this in unipolar depression and we have an excellent pilot~     study to suggest its potential in BPAD-DP and it has never previously been assessed in a~     clinical trial exclusively targeting this patient group). Our previous research strongly~     supports the effectiveness of rTMS paradigms including low frequency right-sided stimulation~     in unipolar depression and suggests these may have value in BPAD-DP. As BPAD-DP is clearly a~     clinical problem of significant impact and with limited treatment options, there is a~     pressing need for the development and definitive testing of novel treatments such as rTMS.~   "
238315|NCT00436007|"~     This study is being done to assess the possibility of the potential integration of malaria~     vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and~     immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI~     vaccine antigens. The Protocol Posting has been updated in order to comply with the FDA~     Amendment Act, Sep 2007.~   "
238316|NCT00435994|"~     The purpose of this study is to evaluate how two different aerosol medications may improve~     airway function in infants with respiratory illness. We are using two different medications~     and comparing the difference in lung function after each medication. We will also be taking a~     nasal wash sample for VEGF. We will be using this in comparing how infants respond to the~     aerosol medications as well. We hope to help standardize medications used for infants with~     bronchiolitis and RSV.~   "
238317|NCT00435981|"~     This is a randomized, placebo-controlled phase II study to investigate if a prime and boost~     of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks~     apart, is safe and can preserve beta cell function in children and adolescents with type 1~     diabetes with a diabetes duration less than 18 months at intervention.~   "
238318|NCT00435968|"~     Subjects will be asked to participate in a four day research study of the immune system~     effects and safety of short-term acute dosing of Cold-fX.~      The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on~     the immune system compared to a placebo (dummy pill). Safety of the acute dosing will be~     determined through various blood tests carried out during the study.~   "
238319|NCT00435955|"~     The purpose of this study is to determine whether an intensified treatment plus Rituximab~     followed by autologous transplantation is superior to a conventional chemotherapy regimen~     also supplemented with Rituximab.~   "
238320|NCT00435942|"~     The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic~     stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the~     device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft)~     through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in~     subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair.~     Long term follow-up is conducted through 5 years.~   "
238323|NCT00435903|"~     The goal of this open trial is to pilot the use of palm pilots as a tool for monitoring~     smoking behavior in individuals with serious mental illness. That is, the investigators aim~     to assess the usefulness and feasibility of using Palm Pilots as a tool for monitoring~     smoking behavior and for coaching participants to use a strategy for delaying and reducing~     cigarette use.~   "
238324|NCT00435890|"~     This randomized controlled trial will introduce a triage liaison physician (TLP) into the~     University of Alberta Hospital Emergency Department (ED) and assess the influence on patients~     who leave without being seen, ED length of stay, and other ED Overcrowding outcomes.~   "
238325|NCT00435877|"~     This study will determine if bone marrow stromal cells can be used as a graft for~     regeneration of bony defects. These cells have the ability to form new bone and to support~     the formation of blood. Stromal cells have been identified in other tissues, such as the~     dermis (underside of skin), spleen, thymus and fat, but it is not known whether these cells~     can make bone and support blood formation as well as bone marrow stromal cells.~      Patients undergoing surgery at Suburban Hospital in Bethesda, Maryland, in which some of the~     bone, dermis, spleen, thymus or fat tissue is removed may be eligible for this study.~      For this study, a small piece of the tissue that is removed during surgery for examination by~     a pathologist will be used for research. Stromal cells from the specimen will be collected~     and grown in the laboratory. The genes and proteins in the different cell types will be~     compared, and the ability of stromal cells from the different tissues to make bone and to~     support the formation of blood will be studied.~   "
238326|NCT00435864|"~     Numerous studies about the potential role of NK alloreactive during a n hematopoietic stem~     cells graft are based on genotypical analyses of the KIR receptors and on genotypic~     incompatibilities between KIR and HLA for couple donor/recipient. There is still a lot of~     issues non resolved: Are KIR really expressed and how occur their expression during time when~     hematopoietic reconstitution? Is it depending on HLA of the recipient?If KIR are expressed,~     what are the mechanisms of alloreactivity of NK cells? Are NK able to lyse tumoral cells?~     Could alloreactive NK cells constitute a therapeutic tool able to induce tolerance and~     elimination of leukemia during hematopoietic stem cells grafts?~   "
238327|NCT00435851|"~     In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid~     carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of~     90-95% of patients. This favorable prognosis is the result of an effective primary therapy,~     which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq~     (100mCi) in case of significant risk of persistent disease. Few centers investigated the~     possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential~     long-term adverse complications for patients and to respond to radioprotection rules for~     family members and medical staff.~      Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid~     hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of~     hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge,~     USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal~     during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that~     needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic~     efficiency needs to be checked.~   "
238328|NCT00435838|"~     This is a retrospective observational study which follows on from CNA106030 (a study~     evaluating whether prospective genetic screening for HLA-B*5701 can reduce the incidence of~     hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35~     subjects who withdrew from CNA106030 when found to be HLA-B*5701 positive. HIV disease~     management and adverse event data in these subjects, where the risk/benefit ratio of~     treatment with abacavir may alter subsequent prescribing, will be collected~   "
238329|NCT00435825|"~     This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks,~     and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with~     chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90~     micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24~     weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly~     for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up~     in all treatment groups for the primary endpoint. The anticipated time on study treatment is~     3-12 months, and the target sample size is 500+ individuals.~   "
238330|NCT00435812|"~     The purpose of this study is to find out if a new investigational hepatitis B virus vaccine,~     HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years~     old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at~     least as good as that of Engerix-B®.~   "
238331|NCT00435799|"~     The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV~     induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in~     improving visual acuity. This is the first Norwegian study concerning CCL.~   "
238332|NCT00435786|"~     In diabetic patients with end-stage renal disease to investigate the prevalence of diabetic~     complications and quality of life and to compare with non-diabetic patients with ESRD and~     diabetic patients with normal kidney function.~   "
238333|NCT00435773|"~     Previous studies have not addressed the question, whether or not a repeated leeching can~     supply symptomatic relief of osteoarthritic pain for extended periods of time. We present a~     randomized study to the effectiveness of single and repeated leech therapy in cases with~     advanced osteoarthritis of the knee using a large patient group compared to a control group,~     who were both blinded to the actual treatment modality.~   "
238334|NCT00435760|"~     This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide~     compared to placebo and tiotropium in patients with severe COPD after a single dose~     treatment.~   "
238335|NCT00435747|"~     The present study aims to compare the pre-emptive analgesic efficacy of parecoxib 40 mg IV/IM~     versus placebo on reducing postoperative acute pain following submuscular breast~     augmentation. Additionally this study is being conducted to evaluate the safety and~     tolerability of parecoxib in this kind of procedure.~   "
238416|NCT00434681|"~     Evaluate the acceptability over 24 hours of a new paracetamol formulation 4.8% paediatric~     oral suspension in children weighing between 3 and 26 kg including limits~   "
238336|NCT00435734|"~     The intervention program Obeldicks was developed for obese children aged 6 to 16 years.~     This intervention is gender- and age specific. The 12-months intervention is based on~     nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality~     of structure, process and results of the intervention. Primary outcome measure is change of~     weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor~     profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI-~     hormones, intima media thickness are measured prior to and after the one-year intervention.~     The changes of these hormones and adipocytokines will allow to answer the questions whether~     the alterations of these hormones are a cause or consequence of overweight. Additionally, a~     genetic screening is performed to characterize the participants to probably predict response~     to intervention.~   "
238337|NCT00435721|"~     The current study aims to develop and evaluate a practical, short-term support and education~     program for relatives of individuals with schizophrenia. This program has been developed to~     maximize efficiency and effectiveness in the following ways:~        1. The intervention specifically targets those factors empirically demonstrated to improve~          family functioning and well being. Specifically, this pilot intervention aims to: a)~          increase relatives’ knowledge about schizophrenia spectrum disorders; b) help families~          attribute distressing behaviors of their ill relatives more accurately, by helping them~          to distinguish behaviors that are directly related to the illness from personality~          characteristics; c) improve attitudes towards the patient and reduce stress in~          interactions with the patient; d) encourage problem-focused coping strategies; e) reduce~          burden; f) provide opportunities for relatives to expand their social support network;~          g) help families learn about and utilize community resources.~        2. The program involves both individual and multifamily group components, in order to reap~          the benefits of both formats. Specifically, multifamily psychoeducation groups~          (involving individuals from several different families) tend to be more economical and~          allow participants to learn from each other, increase their social support networks, and~          reduce feelings of stigma. In contrast, individualized programs can target the specific~          needs of participants.~   "
238338|NCT00435708|"~     Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is~     estimated to cost the health service close to £1 billion every year. Around 80,000 people in~     Northern Ireland suffer from COPD. COPD is clinically defined as a slowly progressive~     condition characterised by airflow limitation, which is largely irreversible. Chronic~     inflammation and oxidative stress are key components of the underlying pathological process~     resulting in airflow limitation. Dietary factors and nutrients that have antioxidant or~     anti-inflammatory properties are therefore of interest with respect to the aetiology of COPD.~     The antioxidant vitamins C, E and beta-carotene are all present in the lung milieu. Such~     antioxidants represent the lung's first line of defence against oxygen free radicals.~     Observational studies indicate that a low dietary intake of antioxidant nutrients, or foods~     rich in antioxidants (e.g. fruit and vegetables), is associated with decreased lung function~     and increased risk of COPD. To date, there have been no food-based dietary interventions~     investigating the effect of increased fruit and vegetable intake on COPD. The investigators~     propose to recruit people with mild to moderate COPD and low fruit and vegetable intakes (<=2~     portions daily) and randomise them to one of two study arms for 12 weeks - either to increase~     fruit and vegetable consumption to at least 5 portions a day, or to follow their normal diet.~     Airway and systemic oxidative stress and inflammation will be assessed at baseline and~     post-intervention in order to determine if fruit and vegetables have the potential to~     alleviate the oxidative stress and airway inflammation associated with COPD.~   "
238339|NCT00435695|"~     The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins~     in the brain and how much stays in the blood over a range of different doses. This study will~     use a medical imaging technique called Positron Emission Tomography (PET) which uses an~     imaging agent called [11C]-WAY100635.~   "
238340|NCT00435682|"~     This is a human trial to study the peripheral effect of therapeutic botulinum toxin~     (botox-A). The trial is performed on healthy normal males. The study comprises of two~     parallel placebo-controlled, double blinded studies.~      In experiment 1 intramuscular Botox will be given in corrugator (one site) and frontalis (two~     sites) muscles on one side and placebo to the other side. Intradermal (i.d.) capsaicin~     injection will be given to both sides (between the two sites of frontalis injection~     horizontally). Capsaicin-induced pain intensity and flare together with the area of~     hypersensitivity to different stimulus modalities will be measured and mapped at specific~     time points using different cutaneous stimuli (thermal, electrical, tactile, pressure). This~     will characterize which fibres and receptors are affected by Botox and will show if Botox~     have a unilateral effect (peripheral) or if it also affects the contralateral side (central~     effect).~      In experiment 2 intradermal Botox will be given in corrugator (one site) and frontalis (two~     sites) muscles on one side and placebo to the other side. I.d. capsaicin injection will be~     given to both sides (between the two sites of frontalis injection horizontally).~     Capsaicin-induced pain intensity and flare together with the area of hypersensitivity to~     different stimulus modalities will be measured and mapped at specific time points using~     different cutaneous stimuli (thermal, electrical, tactile, pressure). This will characterize~     which fibres and receptors are affected by Botox. The effect of intradermal Botox will be~     compared to the results of experiment 1.~      The two experiments will show if the intramuscular Botox exerts its action via a leak of~     Botox from the muscle to the overlying skin.~      Antipruritic effects of Botox on histamine prick test and itch will also be assessed in~     parallel with the experiment 2. In this sub-experiment, 5 Units of Botox will be injected~     intradermally in the middle of volar forearm. The same volume of placebo will be injected~     into the other side. Histamine prick test will induce itch and the effect of intradermal~     Botox will be assessed compared to the baseline. Flare area and visual analogue scale (VAS)~     ratings will be measured.~   "
238341|NCT00435669|"~     The purpose of this trial is to determine the mass balance, pharmacokinetics, metabolism, and~     routes and extent of elimination of BMS-582664~   "
238342|NCT00435656|"~     In this research project, we will study the genetic determinants that influence the~     pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV.~   "
238343|NCT00435643|"~     Context: Obstructive sleep apnea syndrome (OSAS) is associated with cardiovascular morbidity.~     Recurrent episodes of occlusion of upper airways during sleep result in hormonal changes that~     may predispose to high cardiovascular risk.These risks can rapidly be reduced by effective~     nasal continuous positive airway pressure (nCPAP) therapy Objective: To evaluate hypothalamic~     pituitary adrenal axis, insulin resistance, blood pressure values and adipokines in severe~     obese patients with and without OSAS and to determine if continuous positive airway pressure~     therapy (nCPAP) influenced responses.~   "
238344|NCT00435630|"~     The purpose of this study is to determine the learning curve for each of seven tasks in a~     virtual reality laparoscopic simulator by medical students.~   "
238345|NCT00435617|"~     The primary aim of this study is to investigate the effectiveness of the use of a robotic~     hand therapy device in the home environment. We hypothesize that the therapy group will~     improve hand function more than a customary and usual care group.~   "
238346|NCT00435604|"~     This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study~     comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC)~     administered, viscous antibody solution of with and without human recombinant hyaluronidase~     (rHuPH20) in volunteer subjects.~      The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous~     antibody with rHuPH20 will be comparable or shorter than the time required for the injection~     without rHuPH20.~   "
238347|NCT00435591|"~     The study will evaluate the effectiveness and safety of multiple dosing regimens of IV~     conivaptan in subjects with euvolemic or hypervolemic hyponatremia~   "
238348|NCT00435578|"~     The primary objectives of this study are:~        1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive~          small cell lung cancer (SCLC) as measured by objective response rate~        2. To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive~          SCLC~      The secondary objectives are:~        1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive~          SCLC as measured by duration of response, progression-free survival and overall survival~        2. To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM)~      The exploratory objectives of this trial are:~        1. To evaluate the effect of glufosfamide on lung cancer symptoms~        2. To evaluate the role of tumor cell glucose transporter expression on the efficacy of~          glufosfamide~   "
238349|NCT00435565|"~     Background:~      The risk of stillbirth and preterm delivery is three times increased among pregnant women~     with type 1 diabetes compared with healthy pregnant women. Normal blood glucose levels are~     mandatory in order to prevent these complications. Severe hypoglycemia (requiring assistance~     from another person) is the decisive limiting factor for obtaining near-normal blood glucose~     regulation in pregnant women with type 1 diabetes. Severe hypoglycemia occurs in about one~     third of pregnancies complicated with type 1 diabetes and can result in unconsciousness,~     traffic accidents and deaths.~      Aim: To test the following hypotheses:~        1. Severe hypoglycemia is frequent in pregnancy complicated by type 1 diabetes with the~          highest incidence in gestational weeks 8-16 and the lowest incidence in gestational~          weeks 28-34~        2. Predictors for severe hypoglycemia during pregnancy complicated with type 1 diabetes can~          be identified at the first pregnancy visit~        3. Possible pathophysiological mechanisms include changes in the growth hormone system and~          in the renin-angiotensin-system during pregnancy~      Methodology:~      One hundred and eight pregnant women with type 1 diabetes are consecutively and prospectively~     included. In connection with the clinical control at the first pregnancy visit at week 9 and~     in gestational weeks 14, 22, 28, 34 and one day postpartum the following tests are carried~     out:~      The patients are asked to answer a validated questionnaire about mild and severe hypoglycemia~     and hypoglycemia-associated factors such as blood glucose level during hypoglycemia, the~     degree of awareness, pregnancy-associated nausea and vomiting, insulin type and dose etc.~     Other medication, exercise habits, coffee- and alcohol intake, smoking and social status will~     be recorded. In case of severe hypoglycemia a structured interview concerning the episode~     will be performed within 24 hours. Blood glucose, HbA1c, the degree of insulin resistance and~     the levels of IGF1, placenta growth hormone and of the renin-angiotensin-system will be~     monitored.~   "
238350|NCT00435552|"~     The application of Ease-it Spray will alleviate pain secondary to fire ant stings more~     quickly than placebo.~   "
238351|NCT00435539|"~     A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical~     PVD induction for treatment of patients with vitreomacular traction.~   "
238352|NCT00435526|"~     The purpose of this study is to assess anti-CFA/I and anti-CfaE BIgG safety and to determine~     protective efficacy of anti-CFA/I and anti-CfaE BIgG against diarrhea after challenge with~     H10407, a CFA/I-expressing ETEC strain.~   "
238353|NCT00435513|"~     Genetic variations, i.e. polymorphisms, may be associated with gender dysphoria, e.g.~     transsexualism. This study aims to identify such variations.~   "
238354|NCT00435500|"~     The purpose of this study is to determine whether semi-annual fluoride varnish applications~     combined with caregiver counseling are effective in preventing and reducing a severe form of~     dental decay, known as early childhood caries, in native and non-native children aged 6~     months to 5 years.~   "
238355|NCT00435487|"~     To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients~     of non ST elevation acute coronary syndromes who are planned to undergo coronary~     interventions (angioplasty or bypass surgery)~   "
238356|NCT00435474|"~     The purpose of this study is to investigate whether treatment for cancer patients with~     malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain)~     through comparing the effects of two multidimensional interventions including wound~     treatment, psycho-social support and relaxation therapy.~   "
238357|NCT00435461|"~     The primary objective of this study is to compare the nighttime symptom relief of fluticasone~     furoate nasal spray and oral fexofenadine~   "
238358|NCT00435448|"~     The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to~     placebo in subjects with symptomatic BPH.~   "
238359|NCT00435435|"~     The aim of this study was to compare the effect of manual based cognitive therapy in adjunct~     of three different pharmacotherapy.~   "
238360|NCT00435422|"~     The effect of individualized fluid optimization during neuroaxial blockade has not been~     evaluated. The investigators evaluated if if Stroke decrease 15 min after activation of~     neuroaxial blockade and whether SV could be optimized to pre activation values.~   "
238361|NCT00435409|"~     The treatment received with sunitinib plus capecitabine could delay tumor growth longer than~     with treatment with capecitabine alone.~   "
238362|NCT00435396|"~     This will be the first time in humans (FTIH) study with the GSK Bio recombinant gB antigen to~     evaluate safety and immunogenicity of this CMV candidate vaccine with a proprietary GSK~     adjuvant system. The vaccine will be administered to young male healthy subjects at 0, 1 and~     6 months. The trial will assess the safety and immunogenicity of the candidate CMV vaccine.~     An additional secondary objective of this trial is to identify and validate a test which will~     be able to differentiate between previous CMV infection and CMV vaccination. Subjects will be~     followed for a total of 2 years.~   "
238363|NCT00435383|"~     To determine the which method of pain relief is better after current anesthesia care.~   "
238364|NCT00435370|"~     This study will determine the effectiveness of tropisetron plus risperidone in improving~     cognitive symptoms in Chinese people with schizophrenia.~   "
238365|NCT00435357|"~     The purpose of the study is to analyse the clinical and radiological results of a~     postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial~     femorotibial arthritis will be included. The consequences on the patellofemoral joint will be~     thoroughly analysed on skyline view.~   "
238366|NCT00435344|"~     The purpose of this study was to determine whether a pediatric practice-based smoking~     prevention and cessation intervention increases abstinence rates among adolescents.~   "
238367|NCT00435331|"~     The purpose of this study is to determine whether the addition of sapropterin dihydrochloride~     (6R-BH4) to existing treatment has any effect in patients with pulmonary arterial~     hypertension (PAH). Patients with PAH have low levels of a substance called nitric oxide~     (NO). Tetrahydrobiopterin (BH4) is a substance produced by the body that is an essential~     requirement in the formation of NO. NO is thought to be helpful in keeping blood vessels in~     the lung healthy. 6R-BH4 is an experimental (unproven) medicine made in the lab that is very~     much like the BH4 that our own body makes. The researchers are investigating whether 6R-BH4~     can be added safely to current treatment for PAH and whether there is any evidence of benefit~     from its use. The study will take approximately one year to complete from the time~     recruitment begins.~      The primary objective of the study is to evaluate the safety of oral 6R-BH4, administered in~     escalating doses in addition to standard care, in subjects with pulmonary arterial~     hypertension (PAH).~      The secondary objective of the study is to evaluate change in biochemical markers of~     endothelial dysfunction and nitric oxide synthetase activity (coupled and uncoupled) in~     subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care.~      The third objective of the study is to evaluate change in biomarkers of disease progression,~     6-minute walk (6MW) distance, Borg dyspnea scores, and quality of life (QOL) measures in~     subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care.~   "
238368|NCT00435318|"~     The intent of this double-blinded study is to investigate the short (2 months) and long-term~     (over 2 months) therapeutic capabilities of Iontophoresis.~   "
238369|NCT00435305|"~     The purpose of our study is to determine the penetration of continuously infused antibiotics~     at steady state, mainly Meropenem, Vancomycin, Linezolid, Piperacillin/tazobactam and~     additionally cefepim and ceftazidim, into epithelial lining fluid.~   "
238370|NCT00435292|"~     Randomized, double-blind, placebo controlled parallel group, multi center study in subjects~     with moderate-severe osteoarthritis.~   "
238371|NCT00435279|"~     To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects~     receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).~   "
238372|NCT00435266|"~     Primary percutaneous coronary intervention (pPCI) is the preferred treatment in ST elevation~     myocardial infarction (STEMI). The infarct-related artery (IRA) can be opened in more than~     90% of the patients. However, STEMI patients still end up with a persistent perfusion defect~     of highly variable magnitude indicating that adjunctive treatment may add further protection~     against tissue damage. Ischemic preconditioning (IPC) is an intervention by which myocardium~     threatened by ischemia is exposed to short and repeated sublethal ischemic episodes prior to~     sustained ischemia (local IPC). A systemic response with protection of more remote organs~     (remote IPC (rIPC)) also can be induced. We have recently found that the infarct reducing~     effect can be obtained by obstruction of an extremity even though the remote stimulus is~     initiated during sustained occlusion of a coronary artery, the so-called remote~     preconditioning (rPerC). The clinical perspective is now to examine if rPerC can reduce the~     infarct size in patients with unpredictable ischemia in ST elevation myocardial infarction~     (STEMI). We perform a randomized study where patients en route for pPCI are allocated to~     either rPerC or a standard treatment to evaluate whether the tissue damage can be reduced.~     Effect measure will be infarct size determined by scintigraphy (final infarct size and~     salvage).~   "
238373|NCT00435253|"~     Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8~     subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.~   "
238374|NCT00435240|"~     There is uncertainty about the optimal diet in the prevention and treatment of diabetes type~     2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber,~     fruit and vegetables. This study is based on another approach which compares foods that were~     available during human evolution with more recently introduced ones. The basic tenet from~     evolutionary biology is that if human physiology is less adapted to a relatively recently~     introduced diet based on agriculture, this could cause disturbances to human physiology and~     ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2~     is absent or near absent in populations eating a Palaeolithic (Old Stone Age) diet which is~     free from food items produced in agriculture or the food industry. Our study hypothesis is~     that a Palaeolithic diet is better than the standard diabetes diet recommended today in~     treating diabetes type 2.~      Fifteen patients with diabetes type 2 have been randomized to~        1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs,~          and nuts~        2. a standard diabetes diet as recommended by national health authorities.~      The patients eat the diet they have been randomized to for three months and then switches to~     the other diet for another three months. The study is conducted in Primary Health Care~     stations.~   "
238375|NCT00435227|"~     -  The purpose of this study is to describe the effect of a single (IM) dose of motavizumab~          in the upper respiratory tract in children who present with RSV illness but who do not~          require hospitalization at the time of presentation and~        -  Describe the effect of a single 30 mg/kg IM dose of motavizumab in decreasing the need~          for hospitalization due to worsening RSV illness in children who receive outpatient~          treatment~        -  Describe the effect of a single 30 mg/kg IM dose of motavizumab on subsequent~          respiratory status as measured by the Respiratory Assessment Change Score (RACS) and~          change in oxygen saturation~        -  For children who require hospitalization, describe the effect of motavizumab on severity~          of RSV illness during hospitalization [i.e., RACS, oxygen saturation, heart rate, use of~          supplemental oxygen, mechanical ventilation, and duration of intensive care unit (ICU)~          stay]~        -  Describe the effect of a single 30 mg/kg IM dose of motavizumab on duration of symptoms~          of RSV illness (fever, coryza, cough, and parental opinion of return to normal health~          and activity)~        -  Describe the nasal concentration of motavizumab following a single 30mg/kg dose~        -  Describe the serum pharmacokinetics and immunogenicity of a single 30 mg/kg IM dose of~          motavizumab~        -  Describe the effect of motavizumab on markers of inflammation as measured by gene~          microarray and cytokine levels~        -  Evaluate the safety and tolerability of a single 30 mg/kg IM dose of motavizumab in the~          outpatient treatment of children with RSV~        -  Describe the progression and severity of lower respiratory infection (LRI)~   "
238446|NCT00434291|"~     This study will test the safety and efficacy of TG-873870(Nemonoxacin) compared with~     Levofloxacin in adult patients with Community-Aquired Pneumonia(CAP)~   "
238376|NCT00435214|"~     Background:~        -  In most women, HPV infection does not cause symptoms and the infection goes away on its~          own. In a small percentage of women, the HPV infection does not go away and sometimes~          can result in cervical precancer or cancer.~        -  There are several different types of HPV. A better understanding of which types are~          related to cervical precancer and cancer may help guide doctors in clinical management~          of women who test positive for HPV and better understand why some women develop disease~          while others do not.~      Objectives:~        -  To determine whether certain types of HPV are more risky than others and if so, whether~          they warrant separate detection in screening for cervical precancer and cancer.~        -  To determine if lasting infection by different HPV types carry different risk of~          cervical precancer and cancer.~        -  To determine what viral and genetic factors influence the development of cervical~          precancer and cancer.~        -  To evaluate new HPV tests and new biomarkers of cervical cancer risk.~      Eligibility:~      -Women 30 years of age and older who are in the cervical cancer screening program at the~     Kaiser Permanente health plan in Northern California. Women who tested positive for HPV and a~     random sample of women who tested negative for the virus are included.~      Design:~      -Data about participants genetic background and the type of carcinogenic HPV with which they~     are infected are analyzed.~   "
238377|NCT00435201|"~     The purpose of this study is to investigate the mechanism of autoantibody production during~     chronic hepatitis C virus (HCV) infection. 10-50% of individuals with HCV have symptoms of~     mixed cryoglobulinemia (MC). By studying the B cells from HCV-infected individuals with and~     without MC, as well as from healthy controls, we hope to gain insight into the mechanisms of~     autoantibody production and develop new strategies for treatment of MC.~   "
238378|NCT00435188|"~     The purpose of this study is to determine whether a 12-month physical activity counseling~     program, compared to usual care, improves physical performance in a sample of older veterans.~     The primary physical performance outcome is change in gait speed.~   "
238379|NCT00435175|"~     Estradiol promotes and maintains the typical female phenotype characterized by subcutaneous~     fat accumulation. There is evidence to suggest that this effect relies on the ability of~     estradiol to increase the amount of anti-lipolytic α2A-adrenergic receptors, but whether this~     requires long-term exposure to estradiol or is the result of an immediate effect is not~     clear. Objective: To study acute effects of a single dose (4 mg) of 17β-estradiol on regional~     and systemic lipolysis.~   "
238380|NCT00435162|"~     The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan~     (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting~     diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting~     systolic blood pressure [SSBP] ≥ 95th percentile ).~   "
238381|NCT00435149|"~     This study will investigate the effect of one week of immobilization following carpal tunnel~     release surgery versus no immobilization.~   "
238382|NCT00435123|"~     This is a long-term, randomized, placebo-controlled, double blind clinical study of a~     nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition.~     Subjects receive either ProStat 64 or Placebo for three months. At the end of this period,~     all subjects will receive ProStat-64 for a further 3 months at which time the study is ended.~     Parameters of nutritional status (lean body mass and serum protein) will be collected at~     baseline, 3 months and 6 months.~   "
238383|NCT00435110|"~     Current American-European Consensus Conference (AECC) definitions for ALI and ARDS are~     inadequate for inclusion into clinical trials due to the lack of standardization for~     measuring the oxygenation defect. We questioned whether an early assessment of oxygenation on~     specific ventilator settings would identify patients with established ARDS (persisting over~     24h).~   "
238384|NCT00435097|"~     The purpose of this protocol is to develop a detailed MRI technique and haemodynamic maps~     enabling early detection of colorectal metastases in the liver.~   "
238385|NCT00435084|"~     This phase I/II study is designed to determine the safety and tolerability of APO866 for the~     treatment of refractory B-CLL not amenable to aHSCT. APO866 has shown to induce growth~     inhibition in cultures of a wide variety of human hematological malignant cells as well as in~     models with subcutaneously implanted human tumors. APO866 was considered to be safe and~     well-tolerated in a phase I study that treated 24 patients with advanced cancer. APO866 is~     administered by intravenous infusion continuously for 96 hours and is repeated every 4 weeks.~     In this study patients will receive only one cycle of treatment and the study endpoints will~     be evaluated 4 weeks after the start of infusion. Patients will be followed up for 12 weeks~     for safety.~   "
238386|NCT00435071|"~     This study will investigate the postoperative recovery advantages from having a smaller~     incision to a larger incision.~   "
238387|NCT00435058|"~     During the glaucomatous disease process, subpopulations of cells may be dead, damaged or~     healthy. Visual function changes could be observed due to a recovering of the suffering~     ganglion cells after the intraocular pressure reduction. This study aims at evaluating the~     correlation between intraocular pressure reduction and visual function changes in glaucoma~     patients after using antiglaucoma medications.~   "
238388|NCT00435045|"~     The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid~     ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein~     cholesterol (non-HDL-C) in hypertriglyceridemic subjects.~   "
238389|NCT00435032|"~     The purpose of this randomized trial is to compare two commonly utilized surgical treatments~     for children with ruptured appendicitis: early appendectomy, versus interval appendectomy.~     The primary outcome measure is time away from normal activities.~   "
238390|NCT00435019|"~     This trial is conducted in Europe.~      The aim of this research is to compare the efficacy and safety of treatment with NPH insulin~     and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or~     twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin~   "
238391|NCT00435006|"~     The purpose of this study is to assess the prevalence and predictors of pituitary~     dysfunction, as well as secondary out-come in patients with traumatic brain injury or~     spontaneous subarachnoidal haemorrhages.~   "
238475|NCT00433914|"~     To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B~     Recombinant Vaccine when administered to healthy infants.~   "
238392|NCT00434993|"~     Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS,~     Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation~     and increased fluids (edema) in both lungs, making it hard for the lungs to function~     properly. Patients with these conditions require treatment that includes the use of a~     breathing machine (ventilator). The purpose of this study is to find out whether giving~     albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI~     or ARDS makes a difference in how long it takes for a patient to be able to breath without~     the ventilator.~   "
238393|NCT00434980|"~     This is a pilot study evaluating the feasibility of a new family-based intervention for~     schizophrenia. It is designed to help clients diagnosed with schizophrenia to overcome the~     devastating effects of neurocognitive deficits on everyday functioning (Family-Directed~     Cognitive Adaptation, FCA). Cognitive deficits in schizophrenia are known to contribute to~     devastating functional impairments and caregiver burden, as clients rely on caregivers for~     help with basic living needs, such as personal hygiene, time management, social skills, and~     progress towards vocational and educational goals.~      Specifically, we will 1) Develop a manualized, family treatment program designed to improve~     adaptive functioning of patients with schizophrenia, and 2) Conduct a pilot feasibility study~     to evaluate the acceptability and feasibility of this intervention, and to collect~     preliminary outcome data. This will lay the foundation for a controlled trial of the efficacy~     of the intervention. We expect that:~        1. The FCA intervention will be well-received and well-tolerated by clients and families,~          as demonstrated by a high level of interest in the program, a low rate of attrition, and~          a high rate of participant satisfaction.~        2. Client participants in the FCA intervention will show improvements in adaptive,~          independent-living skills (e.g., personal hygiene and self-care, medication management,~          time management, social skills, and responsibility for health maintenance) that will be~          maintained three and six months following completion of the intervention.~        3. Family members participating in the FCA program will show reduced burden of care and~          time spent caregiving, greater satisfaction in their relationship with the client,~          improved self-efficacy in the caregiver role, and reduced psychological distress (e.g.,~          depression, anxiety, and hopelessness) at the completion of the program and at three and~          six-month follow-up interviews.~   "
238394|NCT00434967|"~     The aim is to compare the blood pressure lowering effect of the combination of candesartan~     cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32~     mg alone, HCT 25 mg alone and placebo in hypertensive adults.~   "
238395|NCT00434954|"~     This study in Germany is designed to compare the effects of twice-daily exenatide plus~     metformin and twice-daily premixed human insulin aspart plus metformin with respect to~     glycemic control, as measured by HbA1c, combined with the percentage of patients with at~     least one treatment-emergent hypoglycemic episode. Patients will be treated with study~     therapy for approximately 26 weeks.~   "
238396|NCT00434941|"~     This is a prospective, open-label, multicenter phase IV.II study. Patients with local relapse~     breast cancer will receive radiotherapy concomitant to the administration of capecitabine.~     Total dose of radiotherapy will be 50 Gy administered in daily session of 200 cGy.~     Radiotherapic treatment will not be longer than 6 weeks.~      All patients will receive 1650 mg/m2 by mouth, per day (825 mg/m2 twice a day (p.o. bid) for~     35 days.~      Tissue samples must be analysed to determinate the human epidermal growth factor receptor-2~     (HER2)by FISH technical.~   "
238397|NCT00434928|"~     Assess the dietary intake of children aged 6-12 years by means of a 24-hour recall and 3-day~     food record and asses the nutrient status of Vitamin B6, serum ferritin, serum zinc and serum~     copper of the same children by means of standard laboratory assessments.~   "
238398|NCT00434915|"~     Dehydroepiandrostrone (DHEA) and its sulfated ester (DHEAS) are high circulating weak~     androgens which have been associated with conditions that accompany age-related decline such~     as sarcopenia, hyperinsulinemia, osteopenia, and cardiovascular disease. The decline in DHEA~     with age is particularly marked in postmenopausal women. Exercise has always been advocated~     in women; benefit has been demonstrated inmuscle, bone and lipid physiology, as well as~     perception of energy and sense of well-being. This study aims to explore the combined effect~     of both DHEA and exercise in postmenopausal women, age range 55-75 years old. Subjects will~     receive DHEA (50mg/day) or placebo for a 12-week period. At the beginning and conclusion of~     the study patients will undergo testing for muscle strength, body composition, VO2 max,~     insulin sensitivity, muscle biopsy with mitochondria enzyme measurements, and psychological~     analysis. Blood samples pre and post intervention will also be obtained and the level of~     selected anabolic markers, lipids, and androgenic and sex steroid levels will be assessed.~     For the twelve-week period, both placebo and DHEA treated participants will be involved in a~     resistance and aerobic exercise program coordinated through the GCRC and the Dan Abraham~     Healthy Living Center. Several correlations have been established with respect to exogenous~     DHEA administration in postmenopausal women. None have evaluated oral DHEA therapy in the~     setting resistance and aerobic exercise, key therapies advocated in postmenopausal women. As~     a plausible anabolic hormone DHEA is hypothesized to accentuate the effects of exercise as~     has been shown for testosterone. This study, as a randomized double-blind placebo controlled~     trial, will investigate the effects, if any, of a regimented exercise program and DHEA~     supplementation in postmenopausal women, specifically for evidence of enhancement of exercise~     effect by oral supplementation with DHEA in attenuating age-related decline~   "
238399|NCT00434902|"~     Recent data show that pulmonary hypertension (PH), defined by a tricuspid regurgitation jet~     (TRJ) velocity > or equal at 2.5m/s on Doppler echocardiography, is present in about 30% of~     adults with sickle cell disease (SCD) and is associated with poor prognosis. However in SCD~     the occurrence of PH (defined by mean pulmonary arterial pressure (mPAP)> or equal at 25~     mmHg) is related to at least 3 mechanisms: PH due to hyperkinetic state with high cardiac~     output (CO) but normal pulmonary vascular resistance (PVR <160 dynes), or postcapillary PH~     (pulmonary capillary wedge pressure PCWP >15 mmHg), or precapillary pulmonary arterial~     hypertension (PAH) defined by mPAP > or equal at 25 mmHg, PCWP< or equal at 15 mmHg and PVR >~     or equal at 160 dynes.The aim of this study is to evaluate in a French population of adults~     with sickle cell disease the characteristics, prevalence and prognosis of pulmonary~     hypertension.~   "
238400|NCT00434889|"~     The purpose of this study is to identify the factors that are associated with falls and near~     falls in community-dwelling older adults with early-stage dementia.~   "
238401|NCT00434876|"~     The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in~     improving the sleep in recovering alcohol dependent subjects.~   "
238402|NCT00434863|"~     The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and~     EMG activity.~   "
238403|NCT00434850|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells~     are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess~     the safety and efficacy of deoxyspergualin (DSG), an immunosuppressant drug, on~     post-transplant islet function in people with type 1 diabetes who have not responded to~     intensive insulin therapy.~   "
238404|NCT00434837|"~     The anterior cruciate ligament (ACL) is one of four strong ligaments connecting the bones of~     the knee joint. If overstretched, the ACL can tear. Reconstruction of a torn ACL is now a~     common surgical procedure. The amount of tension applied to the ACL during reconstruction may~     indirectly affect the possible onset of arthritis over time. The purpose of this study is to~     determine the effect of initial graft tension set during ACL reconstruction surgery on the~     progression of knee arthritis over at least a 12-year period.~   "
238405|NCT00434824|"~     In this study we have evaluated the effects of three different doses of oral testosterone~     undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism~     and low blood levels of the male hormone testosterone.~      Specifically, we have studied the effects on:~        -  symptoms suggestive of low testosterone levels~        -  blood testosterone and other hormone levels~        -  bone mass~        -  muscle mass and fat mass~        -  muscle strength~        -  prostate~        -  lipids, hematocrit~   "
238406|NCT00434811|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells~     are destroyed, resulting in poor blood sugar control. The purpose of this study is to~     determine the safety and effectiveness of islet transplantation, combined with~     immunosuppressive medications, for treating type 1 diabetes in individuals experiencing~     hypoglycemia unawareness and severe hypoglycemic episodes.~   "
238407|NCT00434798|"~     The primary objective of this study is to establish a human Campylobacter jejuni infection~     model with the following characteristics:~        1. Safe application~             1. Infectious period risk mitigated by close monitoring and prospectively applied~               early treatment criteria~             2. Potential post-infectious sequelae risk mitigated by appropriate strain and host~               selection~        2. Campylobacteriosis attack rate of at least 75%~      Secondary objectives are to determine humoral, cell-mediated, and mucosal immune responses in~     the newly established human C. jejuni infection model and evaluate short-term (< 3 mo)~     protection upon repeat exposure to homologous C. jejuni strain and assess immune responses~     associated with protection.~   "
238408|NCT00434785|"~     To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy~     Japanese subjects.~   "
238409|NCT00434772|"~     Thesis Infants of diabetic mothers are at high risk to develop hypoglycemia after birth.~      After birth, glucose and ketone bodies are the main substrates of brain energy. Under normal~     condition, the adrenergic response seen immediately after birth suppresses insulin release~     and stimulates glucagon secretion which enhances gluconeogenesis and ketogenesis.~      An inversion of the insulin/glucagon ratio is seen soon after birth as a normal, physiologic~     phenomenon. Consequently, a post delivery glucose nadir is reached between 30 to 90 minutes~     after birth, followed by a spontaneous recovery before 3-4 hours of age.~      In infants of diabetic mothers, this inversion of the ratio is postponed and a more profound~     and sustained hypoglycemia is seen.~      Early feeding is of great importance to diminish the severity and incidence of hypoglycemia.~     But, if despite an appropriate calorie intake, low levels of sugar are seen, an intravenous~     infusion of glucose should be commenced. In case that IV glucose is not effective or can't be~     supplied immediately, intramuscular glucagon is a therapeutic alternative.~      We hypothesize that a single intramuscular injection of glucagon together with the~     appropriate oral intake of nutrients is a safe and an effective alternative to the IV~     infusion of glucose alone in the treatment of hypoglycemia in term infants of diabetic~     mothers.~      Methods Appropriately grown or large for date, term infants of insulin treated diabetic~     mothers, with no other known medical problems, are potential candidates for our study.~      Hypoglycemia will be defined as serum glucose level lower than 45 mg%. Infants of diabetic~     mothers will arrive to the nursery and immediately receive early feeding before 30 minutes of~     life. At that time, glucose will be checked. If glucose level is lower than 45 mg%, treatment~     with IV glucose or IM glucagon will be initiated. Glucose will be checked every hour for 4~     hours and then every 3 hours (before each meal) for the next 20 hours.~      In case blood glucose level is lower than 20 mg% or falls below 45 mg% despite glucagon~     treatment, IV glucose will immediately be instituted.~      Our aim is to check that IM Glucagon is as good as IV glucose in the treatment of~     hypoglycemia in infants of diabetic mothers. We will compare glucose levels after treatment~     with IV glucose and IM glucagon, the time till normalization of glucose and full feeding is~     achieved and the number of hospitalization days in both groups.~   "
238410|NCT00434759|"~     Primary objective:~      The purpose of this study is to examine efficacy and efficiency of a Stepped Care Program~     (SCP) for patients with Social Phobia in comparison to the standard cognitive therapy for~     Social Phobia according to D.M. Clark.~      Secondary objective:~      Further, it is intended to identify mechanisms of change which mediate treatment outcome and~     to identify differential predictors for therapy success for the two treatment conditions.~   "
238411|NCT00434746|"~     The purpose of this study is to assess the safety and tolerability of ascending single IV~     doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.~   "
238412|NCT00434733|"~     This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of~     FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3~     weeks apart.~   "
238413|NCT00434720|"~     The GlideScope video laryngoscope (Verathon) is an intubating device that uses a~     high-resolution camera embedded into a plastic laryngoscope blade. An LED provides~     illumination. The GlideScope often provides a good laryngoscopic view, but passing the~     endotracheal tube (ETT) through the vocal cords is sometimes difficult. Because of the 60~     degree anterior curvature of the GlideScope's blade, ETT's must have stylets inserted so that~     the ETT distal tip can be positioned anteriorly. Various authors have recommended different~     angles of the ETT to optimally place it into the trachea. Previous study demonstrated that 90~     degree sharp bend was both faster and subjectively easier in a heterogeneous group of~     intubators. With the introduction of a rigid GlideScope Specific Stylet by the manufacturer,~     the question arises as to the the best configuration of stylet for the ETT. Therefore, this~     prospective, randomized, single-blinded trial is proposed.~      The null hypothesis is that there will be no difference between the GlideScope Specific~     Stylet and the standard malleable stylet.~   "
238414|NCT00434707|"~     Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and~     cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery~     needs to be overcome by additional iris manupulations to dilate the pupils which increase the~     liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of~     failure of glaucoma surgery. The proposed trial is an observational study to analyse post~     operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular~     lens implantation with small pupils in persons with glaucoma coexisting with cataract.~   "
238415|NCT00434694|"~     This is a study of different techniques for treatment of atrial fibrillation using a~     procedure called radiofrequency catheter ablation. Atrial fibrillation (called AF) is when~     the upper chambers of the heart (the atria) beat much faster than the lower chambers, causing~     the heart to beat less effectively. AF can cause stroke, impaired performance, palpitations,~     shortness of breath, passing out and other symptoms. Radiofrequency ablation involves~     placement of catheter/electrode wires into the heart through plastic tubes inserted into~     veins / arteries in both the groins and the right side of the neck under local anesthesia.~     Radiofrequency energy is delivered to the areas inside the heart that cause the rapid firing~     of the atria, causing small lesions or burns that destroy the heart tissue where the extra~     electrical impulses come from. Commonly this area is where the four pulmonary veins (PV)~     deliver blood from the lungs to the left side of the heart, and the procedure is also~     referred to as pulmonary vein isolation or PVI.~      This study compares two different strategies for performing the pulmonary vein isolation~     procedure, and compares the effect using two different types of radiofrequency ablation~     catheters.~   "
238417|NCT00434668|"~     The aim of this study is to evaluate the tolerability (in terms of drug delivery and~     toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely~     resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients~     will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.~   "
238418|NCT00434655|"~     -  The investigators aim to determine the clinical and metabolic outcomes of two available~          bariatric restrictive procedures: laparoscopic adjustable gastric banding (LAP-BAND) and~          laparoscopic sleeve gastrectomy for the treatment of morbid obesity (BMI > 35 with~          comorbidities or BMI > 40) in VETERANS.~        -  The investigators hypothesize that the short and long term outcomes between laparoscopic~          adjustable gastric banding (LAP-BAND) and sleeve gastrectomy are similar in VETERANS.~   "
238419|NCT00434642|"~     This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the~     safety and efficacy of bevacizumab, administered in combination with carboplatin with~     gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary~     peritoneal, or fallopian tube carcinoma.~   "
238420|NCT00434629|"~     Patients with B-cell lymphoma who relapse after autologous transplant tend to have a poor~     prognosis. Currently, there is no standard treatment for such patients. Bexxar is a~     radioactive antibody therapy that has shown a 60-80% response rate in non-transplanted~     patients with relapsed B-cell lymphoma. This study will test the safety and efficacy of~     Bexxar in the treatment of patients whose B-cell lymphoma has relapsed after an autologous~     transplant.~   "
238421|NCT00434616|"~     Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases~     the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of~     arteriosclerosis and/or diabetes. If surgical and other methods for the improvement of blood~     supply for the leg have failed or are not possible, most of these patients will proceed to~     amputation of the leg.~      Bone marrow contains cells which can induce and augment the growth of new, small arteries~     called collateral arteries. It has been shown in animals and in some case series that the~     transplantation of a concentrate of the patient's own bone marrow with stem cells into the~     ischemic limb can improve the blood circulation via the induction of collateral growth.~     However, it is not known if this bone-marrow stem cell induced collateral growth is~     sufficient to avoid otherwise necessary amputations.~      Therefore, we conduct a study to compare the efficiency of concentrated bone marrow cells~     injected into the critically ischemic limb compared to a placebo procedure where only saline~     is injected. We think that the transplantation of autologous bone marrow will reduce the~     number of necessary leg amputations, reduce pain and induce wound healing. In this~     investigation, patients with limb threatening ischemia are randomly allocated either to the~     bone marrow group or to the placebo group. Patients in the bone marrow group will have their~     bone marrow harvested under sedation, and the bone marrow cells are concentrated. The cell~     concentrate will then be injected directly into the muscle of the diseased leg. Patients in~     the placebo group will undergo sedation as well but no bone marrow harvest is done, and~     saline is injected into the ischemic leg. The procedure will require about 1.5-2 hours, and~     the subjects will be admitted to a participating vascular Centre. Monthly examinations up to~     three months after the bone-marrow or placebo procedure are done. After the follow-up of~     three months, the rate of death and amputations and the wound healing process are compared~     between groups. Adverse and serious adverse events will be recorded during this time period.~     Diagnostic studies will be obtained to measure blood flow in the treated leg during the~     follow up period and include skin oxygen measurements, pressure recordings in the leg and~     arteriography. Also, quality of life, pain and wound healing will be assessed.~      After completion of the three months study participation, subjects who have been treated with~     placebo will be able to receive open-label bone marrow transplantation therapy.~   "
238422|NCT00434603|"~     This study utilizes a novel technique—expressive arts therapy—to facilitate social~     integration for youth recovering from acquired brain injury (ABI). Expressive arts therapy is~     defined as the use of the arts and artistic media to explore psychological aspects of life.~     An expressive art (also referred to as 'creative arts' or even just 'arts') encompasses~     drama, music, art (visual arts such as painting, sculpture etc) and dance/movement. It has~     great potential to improve community integration for youth recovering from ABI, through~     facilitating skills required for successful social communication and social cognition. It is~     hypothesized to improve social and emotional functioning compared to a less structured~     creative arts program. It is expected that a combination of directed group activities and~     self-reflection within a creative learning context will improve emotional awareness and~     social and community integration to a greater degree than a non-expressive creative arts~     therapy group, in youth who have suffered an ABIAs community integration enables meaningful~     and productive occupational engagement, enabling opportunities for occupational engagement~     through increased community integration would greatly enhance the quality of life of~     adolescents with ABI.~   "
238423|NCT00434590|"~     The study will evaluate kidney graft function in maintenance renal transplant patients.~   "
238424|NCT00434577|"~     Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK~     candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II~     study will be subdivided into a primary study (108494) and three extension studies (108516,~     108518 & 108520), consisting of one additional visit each at months 12, 24 and 36,~     respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the~     primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the~     GSK1437173A vaccine in healthy elderly population. The study population will be stratified by~     age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim~     of the extension studies is to evaluate the persistence of the immune response induced by the~     candidate HZ vaccine during a long term period.~      No new subjects will be enrolled during the extension phases of the study.~   "
238425|NCT00434564|"~     Objective~        1. To compare the incidence of adverse cardiac events among the patients discharged after~          evaluation through ACTION protocol with those through conventional protocol. The adverse~          cardiac events for the follow-up are defined as any of the followings:~             -  Cardiac related death~             -  Ventricular fibrillation~             -  Myocardial infarction~             -  Cardiogenic shock requiring the inta-aortic balloon pump circulatory assistance~             -  Acute pulmonary oedema requiring endo-tracheal intubation~        2. To study the sensitivity / predictive values of the various components of ACTION :12~          lead ECG ST monitoring , serial serum markers for myocardial necrosis (myoglobin, CKMB,~          TnT, graded exercise testing, stress tetrofosmin scan/ stress echocardiography) in~          predicting adverse cardiac events.~      Design -prospective randomised clinical trial~      Participants~      -patients above 25 years of age presenting to the ED with chest pain consistent with~     myocardial ischaemia but with a 12 lead ECG non-diagnostic of myocardial ischaemia .~      Intervention~      Patients were monitored continuously with a 12 lead ECG and ST segment trend monitoring and~     blood will be drawn at 0,3,6 hours after arrival at ED for serial myoglobin, creatine kinase~     MB isoenzyme (CKMB) and Troponin T (TnT) . Patients who have ECG and blood test consistent~     with myocardial necrosis were admitted to the CCU. A senior doctor in the ED reviewed~     patients who were not admitted after 6 hours of observation.~      Study Group~      A stress tetrofosmin nuclear scan was done . Patients were then admitted and discharged~     depending on the results of the stress tetrofosmin scan.~      Control group (conventional protocol)~      Patients were then be admitted or discharged at the discretion of the senior ED doctor.~      Measurement Patients were followed up at 1 week , 2 weeks , one month and six months for any~     adverse cardiac events such as cardiac related death , ventricular fibrillation , and~     myocardial infarction.~      Statistical analysis Logistic regression analysis were used to compare the proportion of~     adverse events in the two treatment groups.~   "
238733|NCT00430495|"~     This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective~     dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid~     arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha~     (TNFa) antagonist due to lack of efficacy.~   "
238426|NCT00434551|"~     This is a prospective study aimed to validate the ability of capsule endoscopy to accurately~     diagnose small bowel Crohn's disease in symptomatic patients who have a non-diagnostic~     standard workup. Patients will be randomized to undergo capsule endoscopy either one week or~     five weeks after enrolment. Patients will be followed up for up to 3 months after capsule~     endoscopy.~   "
238427|NCT00434538|"~     This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the~     wound repair of diabetic neuropathic foot ulcers.~      The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing~     a clinically significant advantage over the standard of care in the repair of diabetic foot~     ulcers.~   "
238428|NCT00434525|"~     -  The investigators aim to determine the clinical and metabolic effects of sleeve~          gastrectomy with or without omentectomy in the treatment of morbid obesity.~        -  The investigators hypothesize that the endocrine suppression of ghrelin (appetite~          hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy~          (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits~          for morbidly obese patients.~   "
238429|NCT00434512|"~     GSK has constructed a new HIV immunogen comprised of conserved parts of the HIV virus (gag,~     pol and nef). The principal objectives of this study are to evaluate the reactogenicity and~     safety of this candidate vaccine with or without a GSK proprietary adjuvant system at three~     different doses and to evaluate the CD4+ T-cell response in terms of proportion of responders~     to the antigens two weeks after the second vaccination.~   "
238430|NCT00434499|"~     This study will examine whether epigallocatechin gallate (EGCG), a major component of green~     tea, affects how the body responds to insulin in healthy and obese people. Insulin is not as~     effective in people who are overweight, have high blood pressure or diabetes. This condition~     is known as insulin resistance. Laboratory studies suggest that green tea or EGCG treatment~     lowers blood pressure, lowers blood sugar and increases blood flow. This study will see if~     EGCG improves insulin resistance or insulin's effects on blood flow in people with insulin~     resistance.~      Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for~     this study. Participants are randomly assigned to take EGCG or a placebo ( inactive dummy~     pill ) in two 4-week treatment phases with a 2-week period of no study medication before each~     treatment phase. After the first 4-week treatment, patients on placebo are switched to EGCG~     and those on EGCG are switched to placebo. In addition to treatment, participants undergo the~     following procedures during the study period:~        -  Screening, including medical history, physical examination and blood and urine tests,~          and finger-stick blood sugar measurement for patients with diabetes~        -  Complete a dietary and physical activity questionnaire and consult with a dietitian~        -  Blood and urine tests~        -  At-home and clinic blood pressure monitoring~        -  Glucose clamp test to measure how the body responds to insulin. This test is done three~          times during the study. A needle is placed in a vein in each of the subject's arms, one~          for sampling blood and the other for infusing insulin, glucose and potassium. Glucose~          and insulin levels, electrolytes, lipids, fatty acids, cytokines and epicatechin are~          measured.~        -  Forearm blood flow measurement with microbubbles and ultrasound. Before beginning the~          glucose clamp test, a test of how well the blood vessels relax is done. A device that~          measures the size of the artery in the upper arm is placed above the elbow. Blood flow~          in the muscle of the forearm is measured by ultrasound using a small infusion through a~          vein of microbubble contrast agent consisting of gas-filled bubbles the size of red~          blood cells. The contrast agent is infused over a 7- to 9-minute period at the beginning~          of the glucose clamp test and again 2 hours after the beginning of the test.~   "
238431|NCT00434486|"~     To investigate a potential pharmacokinetic interaction between SKI-606 and ketoconazole when~     co-administered.~   "
238432|NCT00434473|"~     The study will be conducted at 15-20 US centers in a randomized, placebo-controlled,~     double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients~     at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC),~     fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL.~   "
238433|NCT00434460|"~     The purpose of this prospective, multicentre, time-series study is to develop, implement,~     refine, and evaluate a sustainable behaviour change strategy in the intensive care unit~     (ICU).~   "
238434|NCT00434447|"~     This study is designed to monitor the safety and efficacy of long-term treatment with~     zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the~     jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment~   "
238435|NCT00434434|"~     This was a multicenter, randomized, double-blind, parallel-group, three-arm,~     placebo-controlled study designed to demonstrate the efficacy of two different formulations~     of omalizumab compared with placebo in reducing the airway reaction to an inhaled~     aeroallergen solution in adult subjects with mild allergic asthma.~   "
238436|NCT00434421|"~     Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance~     and adverse events with subcutaneous allergen immunotherapy have generated interest in~     delivering immunotherapy sublingually (under the tongue). The purpose of this study is to~     evaluate the safety of a cockroach extract given sublingually to people with perennial~     (year-round) allergic rhinitis, with or without asthma.~   "
238437|NCT00434408|"~     A community based trial that seeks to address the effect of umbilical cord cleansing using~     4.0% chlorhexidine cleansing solution~   "
238438|NCT00434395|"~     The purpose of the study is to assess the effects of MOA-728 on cardiac repolarization in~     healthy subjects.~   "
238439|NCT00434382|"~     The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory~     suppression should be evaluated during a wide spectrum of clinically common forms general~     anesthesia.~   "
238440|NCT00434369|"~     A multi-center, open-label, single-arm Phase II trial assessing the efficacy and safety of~     weekly bolus infusions of 5-fluorouracil combined with CoFactor (5-10~     methylenetetrahydrofolate) in advanced breast cancer patients who failed anthracycline and~     taxane chemotherapy regimens.~   "
238441|NCT00434356|"~     This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide~     a preliminary assessment of the safety and efficacy of sunitinib when combined with~     bevacizumab and paclitaxel in patients who have not previously received chemotherapy for~     locally recurrent or metastatic breast cancer.~   "
238442|NCT00434343|"~     The purpose of this study is to determine if a randomized trial of physical therapy for~     pelvic pain is feasible.~   "
238443|NCT00434330|"~     The purpose of this study was to determine the dose ranges of peginesatide administered~     intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose~     hemoglobin values were stable on epoetin (alfa or beta).~   "
238444|NCT00434317|"~     This study will evaluate the safety, tolerability and efficacy of zoledronic acid~     administered intravenously every 3-4 weeks in patients with bone metastases from either~     breast cancer or prostate cancer.~   "
238445|NCT00434304|"~     This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in~     Parkinson's Disease patients.~   "
238447|NCT00434278|"~     This was a multicenter, randomized, double-blind, placebo-controlled study of patients with~     severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.~     Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks~     (placebo group). Patients must have had stable CF symptoms without any change in therapy for~     2 weeks prior to enrollment in order to participate.~   "
238448|NCT00434265|"~     Obesity is the consequence of a chronic disequilibrium of fat balance. Genetic factors~     determine predisposition to obesity, but the most often mentioned idea is that environmental~     factors, such as a high-fat diet and a sedentary lifestyle, join to favour weight gain and~     explain the increased prevalence of obesity in our westernized societies. Since lipogenesis~     is negligible in humans, obesity represents the consequence of altered fat partitioning~     between oxidation and storage, likely due to a preferential directing of dietary fat towards~     adipose tissue and away from muscle. Interventions that favour partitioning of dietary fat~     towards muscle for oxidation might thus protect against weight gain. Exercise may be one kind~     of such intervention but the scant data on dietary fat metabolism does not allow clear~     conclusions, in particular in obese subjects. One question concerns the impact of the type of~     fat eaten: the effects of physical inactivity may vary according to the length and saturation~     degree of the fatty acids. We hypothesize that 1) physical activity of moderate intensity,~     independently of its effect on energy balance, will favor a preferential trafficking towards~     adipose tissue, will modify the expression of genes implicated in fat oxidation and storage~     and partly correct the abnormalities observed in obese subjects, 2) effects of physical~     activity vary according to the saturation degree of fat. Twelve obese subjects, aged 18 to~     55, will undergo tests before and after 2 months of training at current recommendations to~     ascertain dietary fat partitioning using stable isotopes and to determine changes in gene~     expression with muscle and adipose tissue microbiopsies.~   "
238449|NCT00434252|"~     This Phase II, multicenter, randomized, double-blind, placebo-controlled trial was designed~     to estimate the efficacy and characterize the safety of bevacizumab when combined with~     carboplatin + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy~     alone in patients with previously untreated metastatic melanoma.~   "
238450|NCT00434239|"~     This study is mainly assessing the safety of Revlimid in combination with Ancestim~     (recombinant human stem cell factor) in patients with symptomatic myelodysplasia. Of those~     two compounds, Revlimid has been shown to be an active drug in myelodysplasia. Clinical~     responses will also be assessed.~   "
238451|NCT00434226|"~     This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide~     a preliminary assessment of the safety and efficacy of sunitinib when combined with~     carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced,~     recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All~     patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with~     pleural effusions, Stage IV, or recurrent).~   "
238452|NCT00434213|"~     This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit~     the study site over a period of approximately 14 weeks.~   "
238453|NCT00434200|"~     Aim of the study was to investigate the effectiveness (functional ability and physical~     capacity) and safety (disease activity and damage of the joints) of long-term high-intensity~     weight-bearing exercises in patients with rheumatoid arthritis (RA).The training proved to be~     safe and effective.~   "
238454|NCT00434187|"~     The primary objective is evaluate the safety, tolerability, and pharmacokinetics of multiple~     doses of ERB-041, an investigational drug, in healthy, female Japanese subjects.~   "
238455|NCT00434174|"~     This study will evaluate the safety of everolimus in combination with pemetrexed when used as~     treatment in patients with non small cell lung cancer.~   "
238456|NCT00434161|"~     The purpose of this study was to evaluate the efficacy and effect of palifermin on the~     incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by~     autologous peripheral blood stem cell transplantation. Amendment 01 (April 07) introduced~     three cataract assessments to be carried out at Screening, Month 6 and Month 12 in response~     to FDA and EMEA follow up measures.~   "
238457|NCT00434148|"~     This study will evaluate the safety and efficacy of two different doses of Pasireotide in~     patients with de novo or recurrent/persistent Cushing's Disease.~   "
238458|NCT00434135|"~     The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta~     (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of~     a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG~     regimen) in terms of toxicity and QoL~   "
238459|NCT00434122|"~     The main purpose of this clinical research study is to investigate if degarelix can~     synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the~     lining of the womb.~   "
238460|NCT00434109|"~     The purpose of this study is to decide if a medicine that slows growth of new blood vessels~     can be give after the embolization procedure to prevent or delay new growth of blood vessels~     to tumors.~   "
238461|NCT00434096|"~     The primary objective of this study is to assess the efficacy of SR141716 compared to placebo~     on body weight and triglycerides changes over a period of 52 weeks.~      Secondary objectives are:~        -  To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on~          HDL-cholesterol and visceral fat area.~        -  To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.~        -  To evaluate the pharmacokinetics of SR141716.~   "
238462|NCT00434083|"~     -  to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate~          85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine~        -  to demonstrate the superiority of Trexima versus the individual components (sumatriptan~          as the succinate 85 mg and naproxen sodium 500 mg), and~        -  to evaluate the safety of the Trexima.~   "
238514|NCT00433407|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors predict how well patients will respond to treatment. It may also help the study of~     cancer in the future.~      PURPOSE: This laboratory study is looking at blood samples from patients receiving~     trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.~   "
238756|NCT00430170|"~     The purpose of this project is to explore the interaction between caffeine and dipyridamole~     on ischemia-reperfusion injury in the forearm.~   "
238463|NCT00434070|"~     This study will examine whether HIV-infected patients are more likely to develop resistance~     to antiretroviral therapy if their blood is not monitored for the number of viruses (viral~     load) in the body.~      A virus that changes (mutates) over time may become resistant to certain types of medicine.~     This resistance may affect future treatment options. This study will compare the amount of~     virus in the blood of HIV-infected patients who have been monitored for viral load with the~     amount of virus in the blood of patients who have not been monitored for viral load. For~     patients who have detectable virus, the type of resistance (mutations) of the virus will be~     determined by comparing the components of the virus with that of a virus that is known not to~     be resistant.~      HIV-infected patients 18 years of age or older who are being treated at the Infectious~     Diseases Institute at Mulago Hospital at Makerere University in Kampala, Uganda, may be~     eligible for this study. Participants are interviewed about the treatments they have received~     for HIV and how they usually take their anti-HIV drugs. They also have a blood sample drawn~     for research tests.~   "
238464|NCT00434057|"~     The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that~     uses machine vision for non-invasive early detection of cutaneous pigmented malignant~     melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with~     illumination in different spectral bands, from visible to near infrared, and automatically~     analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will~     be evaluated. The reference standard will be final interpretation of lesions by central~     dermatohistopathology.~   "
238465|NCT00434044|"~     This study will represent the sponsor's first controlled study of etanercept in Chinese~     subjects with Ankylosing Spondytitis (AS). This trial is designed to assess the safety and~     efficacy of etanercept compared to placebo in the treatment of patients with AS.~   "
238466|NCT00434031|"~     The purpose of this study is to evaluate the rate of pathologic complete response when giving~     docetaxel and trastuzumab followed by caelyx (liposomal doxorubicin), cyclophosphamide and~     trastuzumab before surgery in treating women with operable or locally advanced HER-2 positive~     breast cancer.~   "
238467|NCT00434018|"~     We propose to test an evidence-based wheelchair skills training program to optimize~     wheelchair safety and performance in veterans with SCI. The proposed training program~     incorporates emerging evidence on wheelchair biomechanics and motor-skills learning, and~     addresses recommendations in a new clinical practice guideline. Given the difficulty in~     translating wheelchair skills learned in a therapy clinic with real world problems in the~     home and community post-discharge, we are proposing to conduct the wheelchair skills training~     in and around the veteran's home. The immediate goal is to enhance ability, performance time,~     safety, community participation, and quality of life, while minimizing physical strain. The~     ultimate goal is to reduce morbidity/mortality associated with wheelchair use and promote~     successful aging with a disability.~   "
238468|NCT00434005|"~     Objectives: This proposal addresses the overall hypothesis that ambient fine particulate~     matter exerts cardiovascular health effects via alteration of endothelial homeostasis,~     through a mechanism mediated by oxidative stress. This project will use a controlled human~     inhalation exposure to diesel exhaust particulate (DEP) as a model to address the following~     objectives: 1) Determine whether exposure to inhaled DEP is associated with endothelial~     dysfunction in a concentration-related manner; 2) Determine whether exposure to inhaled DEP~     is associated with evidence of systemic oxidative stress; and 3) Determine whether~     antioxidant supplementation blunts the DEP effect on endothelial function.~   "
238469|NCT00433992|"~     The purpose of this study is to observe the effects of certain anti-HIV medications on~     mitochondrial activity and fat cell death. This study will enroll participants from another~     study, ACTG A5202, who are on treatment regimens that do not include zidovudine, stavudine,~     or other thymidine-containing anti-HIV medications.~   "
238470|NCT00433979|"~     Women represent an increasing proportion of HIV cases globally and in Canada, yet are~     underrepresented in clinic trials. It is therefore critical to conduct this study on~     antiretroviral (ARV) pharmacokinetics (PK) in women to obtain additional information on ARV~     drug levels in women and their relation to adverse events (AEs).~      The hypothesis for this study is three-fold:~        1. that the mean drug levels (Cmin and Cmax) of ARVs will be significantly higher in our~          female population as compared to the mean drug levels in the historical HIV population~          (which is primarily men)~        2. that ARV drug levels, particularly Cmin, are associated with body weight in women~        3. that higher ARV drug levels, particularly Cmax, are associated with higher frequency and~          severity of AEs.~      The objectives of this study are as follows:~      Primary objectives:~        1. To demonstrate that levels of Protease Inhibitors (PIs) and Non-Nucleoside Reverse~          Transcriptase Inhibitors (NNRTIs) are significantly higher in our female population as~          compared to the mean drug levels in the historical general population (which is~          primarily men).~        2. To determine the association between PI and NNRTI minimum concentration (Cmin) and body~          weight in our female population.~      Secondary objectives~        1. To determine the association between maximum concentration (Cmax) and the frequency and~          severity of AEs as measured by the proportion of patients with grade 2 or higher~          laboratory or clinical AEs and the Symptom Index Score in women.~        2. To determine the association between ARV drug levels and age, race, height, body mass~          index, adherence, hormonal levels and therapy, menstruation history, duration of HIV~          infection, duration on ARV therapy, baseline viral load, baseline CD4 count, present CD4~          count, hepatitis B or C infection, class of ARVs, presence of ritonavir and other~          medications.~   "
238471|NCT00433966|"~     The primary objectives of the trial are:~        1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa~          inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in~          patients with acute myocardial infarction undergoing a primary angioplasty strategy.~        2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™~          stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.~   "
238472|NCT00433953|"~     The purpose of this study is to determine how genes influence the response to mycophenolate~     mofetil (CellCept) in children who have had a kidney transplant. The study will look at how~     differences in some genes effect blood levels of mycophenolate mofetil over time in children,~     how often side effects occur and the way that children respond to mycophenolate mofetil.~      The results may lead to better dosing based on individual needs.~   "
238473|NCT00433940|"~     The goal of this study is to clarify the degree of immune suppression in infants requiring~     therapy and to create guidelines for evaluation and prevention of infection in infants on~     oral steroids for hemangiomas.~   "
238474|NCT00433927|"~     The FIRE-3 trial is a multicenter randomized phase III trial investigating 5-FU, folinic acid~     and irinotecan (FOLFIRI) plus cetuximab versus FOLFIRI plus bevacizumab in first line~     treatment of metastatic colorectal cancer. Planned accrual is 284 evaluable patients per~     treatment arm. The primary study endpoint is objective response rate. Secondary endpoints are~     median progression free survival, median overall survival, safety, and secondary resection~     rate.~   "
238476|NCT00433901|"~     The prevalence of overweight children has increased significantly over the past 3 decades and~     3 out of every 4 overweight children become obese adults. Additionally, overweight children~     are now at risk for developing type-2 diabetes while still in their youth. To address the~     issue of childhood weight management, Golan and colleagues provided a model for intervention~     development that targets parents as an exclusive agent of change when attempting to treat~     weight issues for children under 12 years of age. The Kaiser Permanente Colorado (KPCO)~     Weight Management Program (WMP) developed Family Connections, a condensed two-session~     program, based on the Golan model, for parents of children between the ages of 8-12 with a~     Body Mass Index (BMI) greater than the 85 percentile for age and gender. There is a need to~     determine if the content of Golan's model can be translated into a practical intervention to~     be used in usual pediatric weight management practice. The Family Connections study uses~     three arms to determine the effectiveness of healthy eating and active living messages.~   "
238477|NCT00433888|"~     This study will assess the efficacy and safety of intravenous R744 in renal anemia patients~     on hemodialysis.~   "
238478|NCT00433875|"~     Twelve week treatment of AMG 714 in RA patients who failed at least one DMARD, followed by a~     3 month observational period.~   "
238479|NCT00433862|"~     The three main chronic myeloproliferative disorders are polycythemia vera (PV), essential~     thrombocythemia (ET) and idiopathic myelofibrosis (IMF). These are clonal neoplastic diseases~     characterized by proliferation of one or more hematopoietic lineages. Recently a mutation of~     the Janus Kinase 2 (JAK2) gene that leads to the substitution of phenylalanine for valine at~     position 617 of the JAK2 protein, JAK2 V617F, has been found in 76% to 97% of patients with~     PV, 29% to 57% of patients with ET and 50% of patients with IMF. This mutation confers~     constitutive activity on to the JAK2 protein and appears to play an important role in the~     pathobiology of these conditions. However, not all patients with myeloproliferative disorders~     have this mutation and it may not be the primary cause of these diseases. The primary goal of~     this prospective natural history study is to investigate the molecular basis of these~     diseases in groups of patients who have JAK2 V617F and in those who do not. A second goal is~     to identify biomarkers for PV and the other myeloproliferative disorders that are easier to~     measure than JAK2 V617F. Approximately, 150 patients with myeloproliferative disorders will~     be studied over 3 years. The studies will involve the collection of 40 mL to 50 mL of~     peripheral blood from each subject. The blood will be used to assess neutrophil gene and~     protein expression, gene polymorphisms, and plasma protein levels.~   "
238480|NCT00433849|"~     This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal~     anemia patients on Peritoneal Dialysis.~   "
238481|NCT00433836|"~     The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of~     valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight~     stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with~     hypertension (SSBP ≥ 95th percentile for age gender and height).~   "
238482|NCT00433823|"~     Cholesterol is the precursor of glucocorticoids, mineralocorticoids and sex steroids. Both~     adrenal and non-adrenal (ovarian + testicular) all steroid hormones are primarily synthesized~     using the LDL–cholesterol in the circulation. Additionally there is ‘de novo’ cholesterol~     synthesis in both the adrenals and gonads controlled by the HMG-CoA reductase enzyme. A third~     pathway is the use of circulatory HDL–cholesterol by the adrenal and gonadal tissues for the~     synthesis of steroids. Since statins both decrease circulatory LDL and inhibit de novo~     cholesterol synthesis, they are likely to affect the synthesis of steroid hormones. In this~     study we aim to investigate the effects of lowering LDL levels below 70 mg/dL on steroid~     hormone synthesis.~   "
238483|NCT00433810|"~     The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.~   "
238484|NCT00433797|"~     We will study the effect of dietary intervention in patients with prostate cancer. Outcomes~     include serum PSA kinetics, as well as biomarkers of inflammation, antioxidant status,~     oxidative stress and oxidative damage in blood cells, plasma, urine and prostate tissues~   "
238485|NCT00433784|"~     The purpose of this study was to assess whether interpatient variability in the platelet~     response to clopidogrel is partly due to polymorphisms of the hepatic cytochrome P450~     (CYP450)3A and of the clopidogrel-P2Y12 receptor genes.~   "
238486|NCT00433771|"~     The overall objective of this study is to assess the functionality of the WallFlex™ Biliary~     Fully-covered stent as a palliative treatment for malignant bile duct obstruction.~   "
238487|NCT00433758|"~     The purpose of this study is to demonstrate the performance of the GlucoTrack device (non~     invasive device) in measuring blood glucose levels~   "
238488|NCT00433745|"~     This study will determine the safety and effectiveness of an experimental vaccine in~     controlling the abnormal growth of cells in patients with myelodysplastic syndrome (MDS, also~     known as myelodysplasia), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL),~     and chronic myeloid leukemia (CML). It will test whether the vaccine can increase the number~     of immune cells responding to the cancer and thereby slow progression of the illness, improve~     blood counts, reduce the need for transfusions of blood and platelets, or even achieve a~     disease remission. The vaccine contains part of a protein that is produced in large amounts~     by cells of patients with these cancers and an added substance called Montanide that helps~     the immune system respond to the vaccine. Sargramostim, another substances that boosts the~     immune response, is also given.~      Patients 18 to 85 years of age with MDS, AML, ALL or CML may be eligible for this study.~     Candidates are screened with a medical history, physical examination, blood tests, chest~     x-ray and bone marrow biopsy. Women of childbearing age also have a pregnancy test.~      Participants undergo the following:~        -  Chemotherapy entering the study.~        -  Leukapheresis to collect large amounts of white blood cells for infusion before vaccine~          administration.~        -  Participants may need placement of a central line (plastic tube, or catheter) in the~          upper part of the chest to be used for giving chemotherapy, blood or platelet~          transfusions, antibiotics and white blood cells, and for collecting blood samples.~        -  Weekly vaccine injections for nine weeks, given in the upper arm, upper leg or abdomen.~        -  Sargramostim injections following each vaccination.~        -  Standard of care treatment for MDS, AML, ALL or CML, which may include blood or platelet~          transfusions, growth factors, and drugs to control underlying disease and potential side~          effects of the vaccine.~        -  Weekly safety monitoring, including vital signs check, brief health assessment, blood~          tests and observation after the vaccination, on the day of each vaccination.~        -  Follow-up evaluations with blood tests and chest x-ray 3 weeks after the last vaccine~          dose and with blood tests and bone marrow biopsy 7 weeks after the last vaccine dose.~   "
238489|NCT00433732|"~     To determine the efficacy of the Trexima versus placebo as assessed by pain relief and the~     incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary~     endpoints.~   "
238515|NCT00433394|"~     RATIONALE: Collecting informed consent from parents of children with cancer to register with~     the Childhood Cancer Research Network may help the study of cancer in the future.~      PURPOSE: This study is collecting informed consent to register younger patients with cancer~     into the Childhood Cancer Research Network.~   "
238490|NCT00433719|"~     The optimal time to initiate antiretroviral therapy (ART) in HIV-associated tuberculous~     meningitis (TBM) unknown. There are concerns that immediate ART may worsen rather than~     improve outcome, because drug interactiond and toxicities or development of an intracerebral~     immune reconstitution inflammatory syndrome (IRIS). Conversely, delaying ART may result in~     increased HIV-related deaths. To answer this question, we are conducting a randomised,~     double-blind placebo-controlled trial comparing immediate and deferred ART in HIV-infected~     patients presenting with TBM, to assess effect on survival.~   "
238491|NCT00433706|"~     During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an~     intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate~     motion may lead to a mistargeting, which possibly decreases the local control. On the other~     hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive.~     The cost/effectiveness ratio is not well established, as well as the frequency of using such~     imaging during the course of radiation.~   "
238492|NCT00433693|"~     This study will assess the efficacy and safety of intravenous R744 in renal anemia patients~     on hemodialysis.~   "
238493|NCT00433680|"~     The purpose of this study is to evaluate the effectiveness of an obesity prevention program~     when administered to female college freshmen.~   "
238494|NCT00433667|"~     The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on~     treatment of partial onset seizures.~   "
238495|NCT00433654|"~     The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic~     resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing~     System (used in support of Revo MRI™ SureScan Pacing System launch).~   "
238496|NCT00433641|"~     Control of food intake, size and frequency of meals are critical to the development of~     obesity. The stomach signals feelings of fullness after a meal and therefore plays a role in~     control of calorie intake. It is unclear whether the approved appetite reducing drug~     sibutramine changes the function of the stomach. Differences in the way individuals respond~     to treatment with the appetite suppressant sibutramine may also explain why some people lose~     weight while others do not.~      In a previous study of 48 overweight or obese participants, we preliminarily observed that~     variation in the gene for the promoter of the serotonin transporter protein was significantly~     associated with degree of weight loss.~      This new single center clinical study aims to evaluate the effects of the FDA-approved~     appetite suppressing medication, sibutramine (MERIDIA)on weight loss and stomach emptying in~     patients who are overweight or obese. The effect of individual differences in inherited genes~     that modify serrotonin and noradrenergic receptors on weight reduction with sibutramine will~     be tested.~   "
238497|NCT00433628|"~     This study will see if HbA1C, the usual blood test for monitoring blood sugar control in~     diabetic patients, is as accurate in diabetic patients who also have HIV and will evaluate if~     alternative methods for monitoring blood sugar are preferred for HIV infected patients.~      HIV-infected patients 18 years of age and older with type 2 diabetes or high blood sugar may~     be eligible for this study. Participants have two clinic visits (1 to 4 weeks apart) at the~     NIH Clinical Center. At the first visit they provide a detailed medical, social and family~     history and have blood and urine samples collected. Previous blood sugar values are also~     recorded. At the second visit, scheduled for 1 to 4 weeks after the first visit, blood and~     urine samples are collected. Some of the urine and blood samples are stored for future~     research on diabetes, HIV or related conditions.~   "
238498|NCT00433615|"~     This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal~     anemia patients on Predialysis.~   "
238499|NCT00433602|"~     RATIONALE: Chemotherapy may cause blood clots to form in the thigh, leg, and lung. This study~     may help doctors understand how often blood clots occur in patients undergoing chemotherapy.~      PURPOSE: This clinical trial is studying how often blood clots occur in patients undergoing~     chemotherapy for solid tumors, including colorectal cancer, stomach cancer, lung cancer,~     ovarian cancer, pancreatic cancer, prostate cancer, or metastatic breast cancer~   "
238500|NCT00433589|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of~     breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the~     use of estrogen by the tumor cells. Letrozole may fight breast cancer by lowering the amount~     of estrogen the body makes. Giving chemotherapy and hormone therapy after surgery may kill~     any tumor cells that remain after surgery. It is not yet known whether genetic testing is~     more effective than clinical assessment in determining the need for chemotherapy in treating~     breast cancer.~      PURPOSE: This randomized phase III trial is studying genetic testing to see how well it works~     compared with clinical assessment in determining the need for chemotherapy in women with~     breast cancer that is either node-negative or involves no more than 3 lymph nodes.~   "
238501|NCT00433576|"~     This phase I trial is studying the side effects and best dose of resveratrol in treating~     patients with colorectal cancer that can be removed by surgery. Resveratrol may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
238502|NCT00433563|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known~     which schedule of radiation therapy is more effective when given together with chemotherapy~     in treating small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying two different schedules of radiation~     therapy to compare how well they work when given together with cisplatin and etoposide in~     treating patients with limited stage small cell lung cancer.~   "
238503|NCT00433550|"~     This phase II trial studies how well giving irinotecan hydrochloride together with~     oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic~     or unresectable locally advanced small bowel cancer. Drugs used in chemotherapy, such as~     irinotecan hydrochloride, oxaliplatin, and capecitabine, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) may kill more tumor cells.~   "
238504|NCT00433537|"~     This phase II trial is studying how well giving rituximab together with combination~     chemotherapy and bortezomib works in treating patients with untreated mantle cell lymphoma.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as~     cyclophosphamide, doxorubicin, vincristine, and dexamethasone, work in different ways to stop~     the growth of cancer cells, either by killing the cells or stopping them from dividing.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill~     more cancer cells.~      Treatment consists of six agents: bortezomib (Vc), rituximab (R), cyclophosphamide (C),~     vincristine (V), doxorubicin (A), and dexamethasone (D) (VcR-CVAD).~   "
238505|NCT00433524|"~     RATIONALE: Comparing results of diagnostic procedures, such as computed tomography scan (CT~     scan), done before and after radiation therapy to help detect movement of the esophagus may~     help doctors plan the best treatment.~      PURPOSE: This clinical trial is using CT scan to help detect movement of the esophagus in~     patients undergoing radiation therapy to the chest.~   "
238506|NCT00433511|"~     This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and~     paclitaxel to see how well they work with or without bevacizumab in treating patients with~     cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread~     to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast~     cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal~     antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and~     spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the~     tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery~     and help prevent the tumor from returning. It is not yet known whether doxorubicin~     hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without~     bevacizumab.~   "
238507|NCT00433498|"~     RATIONALE: Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Pravastatin may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by making tumor cells more sensitive to chemotherapy. It~     is not yet known whether etoposide and cisplatin or carboplatin are more effective with or~     without pravastatin in treating small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying etoposide and cisplatin or carboplatin~     to see how well they work when given as first-line chemotherapy together with pravastatin~     compared with first-line chemotherapy and a placebo in treating patients with small cell lung~     cancer.~   "
238508|NCT00433485|"~     RATIONALE: Studying samples of blood and tissue from patients with basal cell nevus syndrome~     and from healthy participants in the laboratory may help doctors learn more about changes~     that may occur in DNA and identify biomarkers related to basal cell nevus syndrome.~     Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming~     back. The use of sirolimus may keep basal cell skin cancer from forming in patients with~     basal cell nevus syndrome.~      PURPOSE: This phase I trial is studying topical sirolimus in patients with basal cell nevus~     syndrome and in healthy participants.~   "
238509|NCT00433472|"~     RATIONALE: Diagnostic procedures, such as MRI, may help doctors learn how efaproxiral works~     in the brain and help plan the best treatment.~      PURPOSE: This clinical trial is using MRI to evaluate the effect of efaproxiral on the brain~     in patients with recurrent or progressive glioma receiving treatment on clinical trial~     NABTT-9806.~   "
238510|NCT00433459|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying different combination chemotherapy~     regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.~   "
238511|NCT00433446|"~     RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying how well anti-IL-6 chimeric monoclonal antibody~     works in treating patients with metastatic prostate cancer that did not respond to hormone~     therapy.~   "
238512|NCT00433433|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as~     fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a~     patient's response to treatment and help plan the best treatment. It is not yet known whether~     FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's~     lymphoma.~      PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how~     well it works compared with standard therapy in treating patients with previously untreated~     stage I or stage II Hodgkin's lymphoma.~   "
238513|NCT00433420|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells. Colony-stimulating factors, such as pegfilgrastim, may increase~     the number of immune cells found in bone marrow or peripheral blood and may help the immune~     system recover from the side effects of chemotherapy. Giving combination chemotherapy and~     pegfilgrastim after surgery may kill any tumor cells that remain after surgery. It is not yet~     known whether combination chemotherapy is more effective with or without fluorouracil and/or~     pegfilgrastim in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how~     well it works when given with or without fluorouracil and/or pegfilgrastim in treating women~     with node-positive breast cancer.~   "
238516|NCT00433381|"~     This randomized phase II trial is studying the side effects and how well giving bevacizumab~     together with irinotecan or temozolomide works in treating patients with recurrent or~     refractory glioblastoma multiforme or gliosarcoma. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood~     flow to the tumor. Drugs used in chemotherapy, such as irinotecan and temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving bevacizumab together with irinotecan or temozolomide may kill more~     tumor cells.~   "
238517|NCT00433368|"~     The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for~     the improvement of Overt Hepatic Encephalopathy.~   "
238518|NCT00433355|"~     The purpose of this study is to understand what causes a continuing fatigue for a long time~     with a number of symptoms occurring at the same time (Chronic Fatigue Syndrome-CFS). Epstein~     Barr Virus is among the group of viruses that have been associated with a continuing fatigue~     for a long time with a number of symptoms occurring at the same time, but the cause is still~     unknown.~   "
238519|NCT00433342|"~     An important subgroup of protein-bound toxins are generated as a result of protein~     fermentation in the colon. P-cresol is a fermentation metabolite of tyrosine. In renal~     failure, the colonic generation rate of p-cresol is markedly elevated. After absorption, the~     majority of p-cresol is conjugated to form p-cresyl sulphate. There is clear evidence, both~     in vitro and in vivo, that accumulation of conjugated fermentation metabolites is correlated~     with clinical important endpoints. Free p-cresol is an independent predictor for mortality in~     hemodialysis patients.~      Moreover, in renal failure patients, neither hemodialysis nor peritoneal dialysis is capable~     of normalising the clearly elevated serum concentrations of p-cresyl sulphate. Removal is at~     least partially diminished by the important protein binding of p-cresol. Besides adaptation~     of renal replacement therapies to improve removal of protein bound solutes, another approach~     is to lower the generation of uremic toxins.~      The mechanisms underlying colonic carbohydrate and protein fermentation, responsible for the~     generation of p-cresol, are only partially understood. On the one hand, the ratio of~     fermentable carbohydrates to proteins has been shown to be an important determinant of~     protein fermentation. On the other hand, changes in the colonic bacterial flora influence the~     generation of p-cresol in dogs and in healthy human individuals.~      The effect of antibiotic therapy on bacterial protein fermentation and thus on the generation~     of p-cresol is not known. A reanalysis of data abstracted from a recent longitudinal study in~     peritoneal dialysis (PD) patients suggests that antibiotic therapy may lower p-cresol levels~     substantially. The current study aims at confirming these data in a prospective manner.~   "
238520|NCT00433329|"~     An open label, non-comparative study design is appropriate for this Phase 4 study designed to~     assess whether a core therapy of bosentan, either as monotherapy or with the addition of~     sildenafil, enables patients with pulmonary arterial hypertension (PAH) to achieve a 6-minute~     walk distance (6 MWD) of ≥380 meters after 28 weeks of therapy This design is also~     appropriate to pioneer the utility of cardiac MRI in assessing improved functional capacity~     in PAH and exploring its correlation with other parameters.~   "
238521|NCT00433316|"~     In our prospective, randomized, placebo controlled and double-blinded study we will study the~     efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological~     laparoscopic surgery.~   "
238522|NCT00433303|"~     The purpose of our study is correlate between premature delivery (between week 23-35 of the~     pregnancy) in women that had intercourse up to 12 hours prior to beginning of labor and~     polymorphisms in the gene Prostanoid receptor.~   "
238523|NCT00433290|"~     The primary purpose of this study is to determine if duloxetine reduces pain severity in~     patients with osteoarthritis knee pain.~   "
238524|NCT00433277|"~     Using local immune suppression, the trial seeks evidence for the hypothesis that autoimmunity~     plays a role in the pathomechanism of retinitis pigmentosa.~   "
238525|NCT00433264|"~     Despite major advances in the treatment of chronic kidney disease, the age and sex matched~     mortality far exceeds that of the normal population. As in the normal population, the~     majority of deaths are related to cardiovascular disease. Mounting data point to the lethal~     synergy between chronic kidney disease and cardiovascular disease. This relation is present~     from early stages of chronic kidney disease on.~      Several uremic toxins have been demonstrated to play an important role in kidney disease~     related endothelial dysfunction. In peritoneal dialysis patients, data on the relation~     between uremic toxins, endothelial dysfunction and microparticles are lacking.~      The investigators hypothesize that endothelial dysfunction and uremic toxins are interrelated~     in peritoneal dialysis patients~   "
238526|NCT00433238|"~     The study is designed to answer the following research questions:~        1. Evaluate the acceptability of mental health screening and of the instruments used in a~          sample of community living Chinese seniors;~        2. Determine rates of mental health service utilization in individuals identified at~          screening as having psychological disturbance;~        3. Determine if identifying mental illness and informing participants of screening results~          and with treatment alternatives alters help-seeking pathways.~      The study hypotheses are:~        1. This community sample of Chinese seniors will show a higher prevalence of psychological~          disturbance than their counterparts in the general population;~        2. Emotional well-being will be positively correlated with individuals' physical health and~          social support network.~   "
238527|NCT00433225|"~     The purpose of this study was to evaluate the efficacy of ketorolac 0.4% on quality of vision~     and macula thickening in patients undergoing cataract surgery using the ReStor® multifocal~     IOL.~   "
238541|NCT00433043|"~     Many heart failure patients are unable to reach target beta blocker doses. This study will~     address whether cardiac resynchronization therapy (CRT) will enable uptitration of~     beta-blockers to target doses and whether it will favorably affect remodeling by reducing~     left ventricular end systolic volume (LVESV), with measurable clinical benefit, beyond CRT~     alone (without changes in beta-blocker dose).~   "
238797|NCT00429624|"~     The purpose of this study is to determine whether chiropractic manipulation or medical~     therapy is effective in the treatment of chronic neck pain.~   "
238528|NCT00433212|"~     The machines and oxygen used to help very premature babies breathe can have side-effects,~     such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher~     death rate, a longer time in intensive care and on assisted ventilation, more hospital~     readmissions in the first year of life, and more learning problems) than infants who do not~     develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the~     breathing machine as soon as possible. However, small babies get tired, and still require~     help to breathe. One of the standard and common techniques to help them breathe without a~     tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway~     pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent~     the need to go back on the breathing machine.~      Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives~     some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and~     effective, and already in use as an alternate standard therapy.~      The main research question: After being weaned from the breathing machine, is NIPPV better~     than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?~   "
238529|NCT00433199|"~     Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal~     men~   "
238530|NCT00433186|"~     This is a research study of an investigational product called Mycophenolate mofetil (MMF).~     The study is designed to establish the safety and potential benefit of MMF. MMF has proven~     one of the most effective medications to date for SLE and associated nephritis. It also~     appears to be active in polymyositis and dermatomyositis. This medication inhibits inosine~     monophosphate dehydrogenase, the rate-limiting enzyme in synthesis of guanosine nucleotides.~     It blocks the type II isoform found in activated lymphocytes more potently than the type I~     isoform inhibiting both T- and B-lymphocytes. In SSc, MMF has been tried after anti-thymocyte~     globulin in one small open label study with efficacy with a significant improvement in skin~     score. We will test the safety and efficacy of MMF in SSc. All study patients will receive~     the study medication. The effect of the study medication will be examined in two subgroups of~     patients: those with early or progressive skin disease (skin substudy) and those with muscle~     disease (muscle substudy). The change in modified Rodnan skin score (MRSS) and creatinine~     phosphokinase (CK) for, respectively, the skin and muscle substudies at 6 months after~     treatment will be compared to baseline values.~   "
238531|NCT00433173|"~     The metabolic syndrome is a medical condition defined by high levels of cholesterol in the~     blood, high blood pressure, central obesity (gain in fat around the region of the stomach),~     and insulin resistance (body responds less well to insulin). This state of impaired insulin~     resistance can lead to type 2 diabetes mellitus, which is one of the most common metabolic~     disorders in the U.S. Numerous studies have shown an inverse relationship between insulin~     resistance and testosterone levels in men, however, causality has not been established. This~     protocol investigates the role of testosterone in modulating insulin sensitivity in insulin~     resistant states such as the metabolic syndrome. The hypothesis is that testosterone~     administration will improve insulin sensitivity.~   "
238532|NCT00433160|"~     To evaluate the efficacy of teriparatide based on measurements of bone mineral density at~     lumbar spine~   "
238533|NCT00433147|"~     Gaucher disease is a lysosomal storage disorder resulting from a deficiency in the key enzyme~     beta-glucocerebrosidase (GCase). The enzyme deficiency is caused by genetic mutations, which~     can result in the production of misfolded GCase. AT2101 is designed to act as a~     pharmacological chaperone by selectively binding to the misfolded GCase and helping it fold~     correctly, which may restore GCase activity.~      This study is being conducted to test the safety of AT2101 in patients with type 1 Gaucher~     disease already receiving enzyme replacement therapy (ERT). The study will involve six visits~     over a period of 7 weeks and will evaluate the safety of AT2101.~   "
238534|NCT00433134|"~     Goal:~      To define the causes and issues associated with nonadherence in our population~      Hypothesis:~      There is a difference in the rates and patterns of adherence to transplant medications versus~     other medications also taken by transplant patients~      Methods:~        1. A standardized interviewer-administered confidential survey exploring levels of~          adherence to transplant medications and other medications as well questionnaires on a~          variety of cognitive and other factors known to be associated with adherence.~        2. A brief review of demographics and pertinent laboratory information at the same~          encounter~   "
238535|NCT00433121|"~     The aim of this study is to discontinue antipsychotics and antidepressants, and to study its~     effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).~   "
238536|NCT00433108|"~     A Phase 2, randomized, double-blind, parallel design trial of two doses of mitoquinone~     mesylate (MitoQ) and of placebo in patients with chronic Hepatitis C.~      MitoQ is a mitochondria-targeted antioxidant that rapidly permeates the lipid bilayer and~     accumulates within mitochondria in organs such as liver, brain, heart, skeletal muscle. There~     is strong evidence for increased oxidative stress and mitochondrial damage leading to~     apoptosis via caspase activation. Several studies have shown that MitoQ protects cells from~     apoptosis by acting as a caspase inhibitor and may be effective in reducing cell damage in~     liver disease.~      It is hypothesised that administration of MitoQ will lower raised ALT seen in patients with~     chronic Hepatitis C compared with placebo. Approximately 36 patients who have been~     unresponsive or not suitable for interferon-based therapy will be enrolled at one centre.~     Treatment duration will be 28 days with 28 days post-treatment follow-up.~   "
238537|NCT00433095|"~     1st-line treatment of HER2/neu overexpressing breast cancer~   "
238538|NCT00433082|"~     The metabolic syndrome has been recognized as a proinflammatory state. It has been shown that~     many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and~     low saturated fat diet, independent of weight loss, may be effective in improving the~     metabolic syndrome. Our objective was to evaluate the effect of Ramadan fasting on~     High-sensitive C-reactive protein (hs-CRP) and fibrinogen levels in metabolic syndrome.~   "
238539|NCT00433069|"~     The aim of this study is to investigate the efficacy and safety of an insulin-sensitizer~     (Actos) added to a standard Pegasys/Copegus combination therapy of chronic hepatitis C in~     patients who have previously failed a pegylated-interferon-alpha / ribavirin combination~     without the insulin sensitizer. The primary endpoint is the initial virological response~     (level of HCV RNA in serum) as evaluated after 12 weeks of triple therapy.~   "
238540|NCT00433056|"~     LOTTI study Centers~      This a multicenter, multinational study.~      Clinical phase: III~      Objectives~      The primary objective is to compare efficacy and safety of continuing a conventional HAART in~     chronically infected HIV patients with a therapeutic strategy based on long term,~     immunologically driven treatment interruptions.~      Secondary objectives are:~        -  To verify the risk of developing viral resistance~        -  To verify the effect of the two strategies on metabolic parameters~        -  To verify the possibility to steadily discontinue antiretroviral therapy in patients who~          started it with baseline immunological values higher than those currently recommended by~          international guidelines for HIV treatment~        -  To identify predictive variables of the possibility to safely discontinue antiretroviral~          therapy~        -  To verify the dynamic of CD4+ cell loss and HIV replication after treatment interruption~      Number of Patients: A total of 320 patients.~      Study design:~      Controlled, Randomized, Open study The study will last 5 years~      Treatment arms:~      Patients will be randomized in a ratio 1:1 to one of the two treatment arms Control group~     continuing the ongoing therapy STI group performing long term CD4 guided structured treatment~     interruptions In the STI arm patients will stay off therapy until their CD4 count will drop <~     350 cells/mcL (one measurement will be considered sufficient). At that time point patients~     will resume the HAART regimen they were assuming before STI and will continue HAART until~     they CD4 count will raise > 600 cells/mcL (at least 2 consecutive measurements 2 months~     apart) and their HIV-RNA will drop below the detection limit of 50 copies/ml (one measurement~     will be considered sufficient). When both the CD4 count and the viral load will be within~     these pre-set values they will stop therapy again. There is no limit to the number of~     interruptions and re-start cycles during the study period~      End points:~      The primary end-point for the evaluation of the main objective of the study will be clinical.~     The primary outcome measure will be based on the occurrence of a clinical end-point defined~     as: disease progression (occurrence of any AIDS defining event), death for any cause or the~     occurrence of clinical events requiring hospital admission~      The secondary objectives of the study will be evaluated on the basis of:~        -  Mean variation of blood cholesterol and triglycerides from baseline values.~        -  Development of lipodystrophy or modification of a pre-existing lipodystrophy~        -  Time off therapy.~        -  Variation of CD4 counts and HIV-RNA levels~        -  Genotypic tests to be performed in the case of HIV-RNA > 1000 copies/ml while on therapy~          for at least 4 months or one month after each treatment interruption.~      Statistics:~      The study is powered to evaluate equivalence between the two strategies under the assumption~     that, in the control arm, the primary end-point would be observed in a proportion of subjects~     < 7% and that the same proportion in the STI arm would not exceed 10% with a maximum allowed~     95%CI of 12%. 320 patients will be needed for alfa = 5% and 1-beta = 80%. The primary~     analysis will be made according to the intention-to-treat approach and therefore no~     correction for eventual drop outs is needed. In addition, a secondary per-protocol analysis~     will be performed.~   "
238542|NCT00433030|"~     Since 2004, the Thai Ministry of Public Health has massively scaled up antiretroviral~     treatment programs to provide therapy to more than 80,000 patients with partial support of~     the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM).~      As access to HIV care continues to expand under the universal health coverage system, it is~     important to document and analyze the efficacy, tolerance, toxicity and acceptability of~     antiretroviral therapy within pilot treatment programs, to provide evidence based feedback~     and recommendations to the national program and policy makers.~   "
238543|NCT00433017|"~     This study will evaluate the effect of combination therapy with verteporfin photodynamic~     therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the~     durability of response observed in patients with choroidal neovascularization secondary to~     age-related macular degeneration~   "
238544|NCT00433004|"~     This is a pilot randomized controlled trial to assess the effects of advanced supply of~     emergency contraception versus routine care in a teen postpartum population. The goals are to~     assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the~     prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse~     exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to~     assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and~     unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.~   "
238545|NCT00432991|"~     The purpose of this research study is to investigate if the incidence of nausea and vomiting~     that subjects experience during and after a Cesarean section can be reduced by giving a shot~     of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.~   "
238546|NCT00432978|"~     This study is to determine whether bosentan will alter exercise capacity after rapid ascent~     to high altitude.~      We hypothesize that bosentan administration will improve arterial oxygenation and exercise~     capacity.~   "
238547|NCT00432965|"~     To determine if topical negative pressure therapy delivered by the V.A.C.® device is~     clinically efficacious and cost effective in the treatment of diabetic foot ulcers.~      The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound~     therapy of diabetic foot ulcers. The primary objective is to determine the effect of V.A.C.®~     Therapy on the incidence of complete wound closure.~   "
238548|NCT00432952|"~     The acute effects of farmed rainbow trout, fed by various feeds versus a control meal with~     poultry meat on cardiovascular risk markers and plasma protein expression are investigated.~      The hypotheses of the study are that if the feed are changed from a marine origin to~     primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3~     PUFA) will decrease in the meat and thus possibly result in a decreased effect on health.~     Furthermore, the feed of the trouts are also expected to give rise to differences in the~     human plasma protein profile and fatty acid composition after consumption, which could be~     associated with physiological effects.~   "
238549|NCT00432939|"~     This is a research study to investigate cardiovascular health in people with mild~     hyperparathyroidism. Previous research has suggested that severe hyperparathyroidism may be~     associated with abnormalities in the heart and blood vessels. It is unclear whether mild~     hyperparathyroidism affects cardiovascular health. This study involves the investigation of~     the heart and blood vessels of people with mild hyperparathyroidism. Various non-invasive~     laboratory and radiological test to assess cardiovascular and bone health will be done at set~     intervals over the course of 2 years. It is our hypothesis that patients with primary~     hyperparathyroidism will have subtle abnormalities in their cardiovascular system. Using~     state-of-the art techniques that are sufficiently sensitive to detect these subtle~     abnormalities, we will define cardiovascular features of this disease that have, up to now,~     eluded clear definition. We expect taht the extent of these findings will be related to the~     severity of the underlying primary hyperparathyroidism. We further hypothesize that~     cardiovascular manifestations may regress with successful cure of the hyperparathyroid state.~   "
238550|NCT00432926|"~     This study tests the effectiveness of a behavioral intervention to reduce sexual risk~     behavior in HIV-positive, methamphetamine-using men who have sex with men (MSM). It builds on~     the findings of a previous study (R01 DA012116, Promoting safer sex in HIV+ homosexual and~     bisexual men who use methamphetamine). That study achieved significant short-term results~     that eroded over time. Accordingly, this study hypothesizes that the addition of a~     maintenance component to the already proven counseling and educational components of the~     treatment model will result in longer-lasting positive effects.~   "
238551|NCT00432913|"~     The purpose of this study is to determine the effect of two doses purified EPA (an omega-3~     fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new~     cells) in the lining of the colon for patients with a history of colonic polyps.~   "
238552|NCT00432900|"~     This study will use positron emission tomography (PET) to measure a brain protein called~     peripheral benzodiazepine receptor (PBR) in patients with multiple sclerosis. PBR is created~     during the inflammation process, and brain inflammation is a key feature of multiple~     sclerosis (MS). PBR usually affects one type of brain cell, but it can also cause damage to~     surrounding areas of the brain in patients with MS. PET studies of PBRs and brain~     inflammation may help elucidate the role of these brain cells in patients with MS.~      Healthy normal volunteers and patients with MS between 18 and 70 years of age may be eligible~     for this study. Patients with MS must have had onset of disease between 18 and 40 years of~     age.~      Patients with MS undergo the following procedures:~      Visit 1: Medical history, physical examination, blood tests and magnetic resonance imaging~     (MRI).~      Visit 2: Blood tests and PET scan.~      Visits 3 and 4: MRI and physical examination.~      Visit 5: PET scan and blood tests.~      Visit 6: MRI and physical examination.~      Healthy volunteers undergo the following:~      Visit 1: Medical history, physical examination, blood tests.~      Visits 2 and 3: PET and blood tests.~      Magnetic Resonance Imaging~      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For~     this procedure, the subject lies on a table that can slide in and out of the scanner (a metal~     cylinder), wearing earplugs to muffle loud knocking noises that occur during the scanning~     process. The procedure lasts about 90 minutes; the patient is asked to lie still for up to 25~     minutes at a time. The subject can communicate with the MRI staff at all times during the~     scan. During part of the scan a contrast agent is administered through a catheter (plastic~     tube) placed in an arm vein to enhance the images.~      Positron Emission Tomography (PET)~      The PET scan gives information on brain and body chemistry and function. The subject lies on~     a bed that slides in and out of the doughnut-shaped scanner. A catheter is placed in a vein~     in the arm and another is placed in an artery in the wrist or elbow area. The catheter in the~     arm is used for injecting a radioactive material that the scanner detects, and the other is~     used to collect blood samples. A custom-molded plastic mask is used to support the head and~     prevent it from moving during the procedure. The subject may be asked to perform various~     tasks during the PET scan or to lie quietly. The scan lasts about 2.5 hours.~   "
238586|NCT00432432|"~     Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of~     infliximab in patients with Ankylosing Spondylitis.~   "
239840|NCT00415779|"~     This phase I trial is studying the side effects and best dose of docetaxel when given with~     zoledronic acid in patients with bone metastasis from prostate cancer that has not responded~     to hormone therapy.~   "
238553|NCT00432887|"~     This project contains experimental studies of the effects of the drug caffeine on glucose~     regulation in adults who have Type 2 diabetes. In our experiments, we are testing the~     hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and~     insulin observed after meals in patients with type 2 diabetes. On separate study days~     subjects receive standard meals after taking capsules containing either caffeine or an~     inactive placebo. We measure levels of glucose, insulin, and other chemicals in blood samples~     drawn over the next 3 hours. In a separate study, we use continuous glucose monitoring to~     measure glucose levels during everyday activities on days when subjects receive caffeine or~     placebo.~      These studies do not involve clinical treatment or disease management. However, we hope to~     learn whether a very popular drug impairs the clinical management of a common disease.~   "
238554|NCT00432874|"~     The study objective is to compare traditional and Wong methods of wound hydration for wound~     sealing following cataract surgery.~   "
238555|NCT00432861|"~     The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is~     safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations)~     in children and adults with cystic fibrosis and pancreatic insufficiency.~   "
238556|NCT00432835|"~     The purpose of this research is to determine if temporary gastric electrical stimulation will~     help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when~     the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.~   "
238557|NCT00432822|"~     The aim of the study is to confirm the efficacy and safety of BH4 in the treatment of~     hyperphenylalaninemia caused by phenylalanine hydroxylase deficiency in patients responsive~     to BH4. The primary objective is to assess the effect of BH4 on phenylalanine tolerance~     compared to placebo under optimal blood phenylalanine control and to demonstrate safety in 12~     months long-term treatment. Additionally population PK will be assessed.~   "
238558|NCT00432809|"~     The aim of the study is to compare the relative clinical outcomes between advanced medical~     therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y~     gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes~     and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and~     long term effects of each intervention on biochemical resolution of diabetes, diabetic~     complications, and end-organ damage.~   "
238559|NCT00432796|"~     The purpose of the study is to determine the effectiveness and safety of LMWH postoperative~     bridging therapy (standard of care) versus postoperative placebo bridging therapy~     (experimental arm)for patients with mechanical heart valves or atrial fibrillation or atrial~     flutter who are at high risk for stroke when warfarin is temporarily interrupted for a~     procedure.~   "
238560|NCT00432783|"~     Pharmacologic boosting of protease inhibitors with ritonavir has become standard practice in~     antiretroviral therapy. Patients are instructed to take ritonavir at the same time as its~     accompanying protease inhibitor. However, ritonavir is unpopular with many patients because~     of its large size and because of the recommended need for refrigeration. This study will test~     the hypothesis that adherence to ritonavir is inferior to adherence to its accompanying~     protease inhibitor in patients receiving such therapy.~   "
238561|NCT00432770|"~     The purpose of this study is to establish the overall safety and tolerability of ARC1779 in~     healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with~     respect to parameters of platelet function and von Willebrand Factor activity.~   "
238562|NCT00432757|"~     The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with~     a contact lens compared to placebo in preventing ocular itching associated with allergic~     conjunctivitis~   "
238563|NCT00432744|"~     To show that oral CoQ10 is a safe and effective treatment for children with inborn errors of~     mitochondrial energy metabolism due to defects in specific respiratory chain (RC) complexes~     or mitochondrial DNA (mtDNA) mutations, and that this beneficial action is reflected in~     improved motor and neurobehavioral function.~   "
238564|NCT00432731|"~     Primary objective:~      To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first~     single dose injection in 12 to 15 month-old infants in the 42-day follow-up period~     post-vaccination.~      Secondary objectives: NA~   "
238565|NCT00432718|"~     Compare the incidence of ventilator associated pneumonia with or without tracheal isotonic~     saline instillation before tracheal suctioning~   "
238566|NCT00432705|"~     This study is evaluating reflex board training to see if it will help people who frequently~     roll their ankles. We are investigating several tests that evaluate the ability of the~     neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at~     changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex~     training. It is thought that the reflex training will improve measures of static and dynamic~     balance as well as spinal reflex measures.~   "
238567|NCT00432692|"~     The purpose of this study is to determine wether a falls prevention program can reduce fall~     incidence in people with osteoporosis.~   "
238568|NCT00432679|"~     This study was designed to compare the efficacy and safety of BRL49653C versus placebo with~     concomitant use of sulfonyl urea (SU).~   "
238569|NCT00432666|"~     IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing~     proteins, i.e. free from proteins other than the active toxin. Injected into the muscle,~     incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used~     for treatment of various neurological conditions. This study will investigate the efficacy~     and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the~     upper limb.~   "
238570|NCT00432653|"~     To evaluate the efficacy and safety of rituximab when added to NSAIDs and/ or methotrexate~     both for TNFalpha inhibitor naïve or TNFalpha inhibitor failure patients with moderate to~     severe ankylosing spondylitis~   "
238587|NCT00432419|"~     Given the poor prognosis of HIV-associated non-Hodgkin's lymphoma (NHL) and it's still high~     incidence in HAART era, more intensive therapy is required in patients with initially severe~     stage of NHL or relapsing after first-line chemotherapy.~      The purpose of this study is to evaluate the safety of an intensive chemotherapy followed by~     peripheral blood cell transplantation in these patients.~   "
239841|NCT00415766|"~     The purpose of this study is to compare the clinical outcomes of recombinant human chorionic~     gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.~   "
238571|NCT00432640|"~     Lung cancer is one of the most prevalent cancers and has a very high mortality. Both~     treatment and prognosis depend on the staging. Surgical staging of the mediastinum mainly by~     means of a cervical mediastinoscopy is the gold standard. Mediastinal staging is however a~     field that undergoes a fast technological development. Transesophageal ultrasound guided~     fine-needled aspiration (EUS-FNA) and an endobronchial ultrasound guided transbronchial~     fine-needled aspiration (EBUS-TBNA) are two complementary endoscopic ultrasound techniques~     which together allow cytological analysis of all mediastinal lymph nodes. This means that the~     combination of both techniques enables a complete (bilateral) mediastinal investigation (N2~     and N3, except para-aortal station 6).~      Hypothesis: complete endoscopic ultrasound staging identifies more patients with locally~     advanced disease compared to surgical staging (current standard of care).~      Study design: A randomized controlled multi-center double arm diagnostic phase III trial, in~     which patients are randomly assigned to either surgical staging (arm B) or endoscopic~     ultrasound staging with both EUS-FNA and EBUS-TBNA (arm A).~      Arm A: Examination by EUS-FNA and EBUS-TBNA. These techniques are performed in an outpatient~     one session setting under conscious sedation and take together about 30 to 60 minutes. If no~     metastasis are shown, the patient undergoes a surgical staging procedure (for confirmation).~     For reasons of convenience and patient-comfort, the EUS-FNA investigation is performed before~     the EBUS-TBNA.~      Arm B: Surgical staging with either cervical mediastinoscopy, parasternal mediastinoscopy,~     thorascopic mediastinal exploration or exploratory thoracotomy, performed according to~     institutional practice.~      Patients in whom no lymph node metastasis are found proceed to thoracotomy with systematic~     lymph node sampling to obtain an accurate intraoperative mediastinal staging.~      Primary outcome: The assessment of N2-N3 lymph node metastases.~   "
238572|NCT00432627|"~     This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients~     compared to healthy volunteers.~   "
238573|NCT00432614|"~     The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs.~     placebo in patients with Major Depressive Disorder who are on concomitant treatment with~     escitalopram.~      The secondary objective of this study is to document clinical safety and tolerability of~     SR58611A in association with escitalopram.~   "
238574|NCT00432601|"~     The purpose of this study is to test different methods for communicating information about~     prostate cancer treatment to men. The investigators are studying how best to present~     information so men can make informed decisions about what prostate cancer treatment to~     undergo.~   "
238575|NCT00432588|"~     Hypothesis (H0): Labor duration and obstetric complications are not significantly different~     in the three groups (misoprostol-dinoprostone-oxytocin).~   "
238576|NCT00432575|"~     Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which~     might be clinically useful in the treatment of dependence to nicotine.~      The primary study objective is the assessment of efficacy of 3 doses of surinabant on~     abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of~     surinabant on body weight and its clinical and biological safety.~   "
238577|NCT00432562|"~     This study was a randomized, single dose crossover comparison of the investigational product~     with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective~     was to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.~   "
238578|NCT00432549|"~     The purpose of this study is to assess the benefits of almotriptan used as a transitional~     therapy and topiramate in subjects with medication overuse headaches (MOH.~   "
238579|NCT00432536|"~     Neurologic injuries are frequent and devastating complications following cardiac surgery.~     Previous work conducted by our research group and others has identified the principal~     mechanisms creating both overt and subtle neurologic injuries after cardiac surgery. Current~     work by our group has identified that the causes (thrombotic/lipid emboli, cerebral~     hypoperfusion & hypotension, and gaseous emboli) of these injuries are byproducts of~     processes of surgical and perfusion care. This insight suggests that the redesign of clinical~     strategies and techniques to prevent the occurrence of these intraoperative sources of damage~     may provide an opportunity to reduce the risk of neurologic injury after cardiac surgery.~      The goal of this research is to identify modifiable clinical strategies and techniques of~     surgical and perfusion care associated with the causes (thrombotic/lipid emboli, cerebral~     hypoperfusion & hypotension, and gaseous emboli) of neurologic injury secondary to coronary~     artery bypass graft (CABG) surgery, and subsequently to redesign these processes to reduce a~     patient's risk of a neurologic injury.~   "
238580|NCT00432523|"~     Primary objective:~      To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of~     age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as~     immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates~     to measles, mumps and rubella at 42 days following the vaccination.~      AND/OR~      To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of~     age using separate injection sites, a single dose of VARIVAX® administered by IM route is as~     immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate~     to varicella at 42 days following the vaccination~      Secondary objectives:~        -  To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days~          following the vaccination in children immunised with M-M-R™II and VARIVAX® administered~          concomitantly at two separate injection sites by the same route IM or SC,~        -  To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at~          two separate injection sites by the same route IM or SC.~   "
238581|NCT00432510|"~     The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1~     esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not~     experiencing an HAE attack.~   "
238582|NCT00432484|"~     To study the efficacy of TCM as an effective supplement in addition to the traditional~     treatment in RA.~   "
238583|NCT00432471|"~     The goal of this clinical research study is to evaluate an experimental imaging technology,~     the multispectral digital microscope (MDM), which may help doctors see how far skin cancer~     extends (widens out) on an area of skin. Researchers want to learn if this new technology can~     help doctors identify the exact areas involved in precancerous or cancerous changes in the~     skin.~   "
238584|NCT00432458|"~     RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone.~     Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is~     not yet know whether giving zoledronate together with thalidomide is more effective than~     zoledronate alone in treating multiple myeloma.~      PURPOSE: This randomized phase III trial is studying zoledronate and thalidomide see how well~     they work compared with zoledronate alone in treating patients with early stage multiple~     myeloma.~   "
238585|NCT00432445|"~     The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to~     external photon beam irradiation in children with retinoblastoma as a means of local tumor~     control and ocular retention.~   "
238588|NCT00432406|"~     The purpose of this study is:~        -  To elucidate the immunomodulating properties of anti-TNF-α therapy in patients with~          psoriatic arthritis (PsA).~        -  To ascertain whether magnetic resonance imaging (MRI) is a sensitive tool in measuring~          early response after therapy with anti-TNF-α in the PsA wrist using the Outcome Measures~          in Rheumatoid Arthritis Clinical Trials (OMERACT) guidelines for rheumatoid arthritis~          (RA).~        -  To assess whether the lipid and other cardiovascular risk profiles would improve after~          anti-TNF-α therapy in patients with PsA.~   "
238589|NCT00432393|"~     Purpose: There are some controversies about the effect of Levodopa-Carbidopa on treatment of~     non-arteritic anterior ischemic optic neuropathy (NAION). This study was performed to~     evaluate the effect of Levodopa-Carbidopa on visual acuity, color vision, and visual field in~     patients with recent onset NAION (less than 6 weeks duration).~      Patients and Methods: In this double-blind randomized clinical trial, 13 patients were~     treated with levodopa-carbidopa and 12 patients took placebo for 3 weeks. Visual acuity,~     color vision, and visual field were tested before and at 4th, 12th, 16th, and 24th weeks~     after enrollment, and evaluated.~   "
238590|NCT00432380|"~     This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid~     vaccine when given along with the routine infant immunizations in Philippines.~   "
238591|NCT00432367|"~     Among the best practices recommended for malaria control during pregnancy is ensuring~     effective case management of malaria illness. However, this is often not practiced because~     (1) malaria infection in pregnancy is often asymptomatic, (2) peripheral parasitaemia may be~     absent even when the placenta is heavily parasitized, (3) implementing diagnosis and~     treatment of malaria within a routine antenatal service may be difficult and (4) antimalarial~     treatment options available to pregnant women are limited due to resistance to~     chloroquine(CQ) and sulfadoxine-pyrimethamine(SP0 and paucity of safety and efficacy data on~     other antimalarial drugs in pregnancy, particularly artemisinin combination treatments (ACT).~     Therefore the commonest recommended practice in pregnancy is the administration of SP as~     intermittent preventive treatment (SP-IPTp). However, the effectiveness of SP-IPTp has been~     questioned because parasite resistance to SP is spreading rapidly across sub-Saharan Africa.~      This is a three-arm open label randomised control non-inferiority trial of~     insecticide-treated nets(ITN) plus rapid diagnostic test(RDT) screening, and treatment with~     SP or amodiaquine plus artimisinin(AQ+AS) versus ITN plus IPTp using SP. It is to be carried~     out in pregnant women of all parities presenting at enrolling antenatal clinics with a~     gestation of 16 to 20 weeks at their first booking. The key objectives are to demonstrate~     that (1) the prevalence of severe anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation (2) the~     prevalence of low birth weight (BW < 2500g) at delivery or within 72 hours after delivery (3)~     the prevalence of placenta parasitaemia and (4) the incidence of serious and non-serious~     adverse events in the ITN plus RDT screening and treatment arm are not greater than those in~     the ITN plus IPTp arm. Alongside the clinical assessments, health care cost assessments will~     be done to determine the cost-effectiveness of the two delivery strategies measured as cases~     of severe maternal anaemia averted.~   "
238592|NCT00432354|"~     The aim of this study is to to determine whether atorvastatin 40mg per day is effective in~     the treatment of SLE.~   "
238593|NCT00432341|"~     The purpose of this study is to compare two types of botulinum toxin type A to treat the~     involuntary muscle contractions in the neck~   "
238594|NCT00432328|"~     Severe scarring is a common problem following breast reduction surgery, studies have shown~     that over 64% of patients develop a hypertrophic scar at three months after the operation.~     Scar severity can be influenced by a large number of factors including age, sex, skin~     thickness and tension, ethnicity and the position of the scar on the body. Therefore the most~     sensitive and reliable method to assess the efficacy of an anti-scarring treatment is to~     compare bilateral wounds on the same individual. Bilateral breast reduction surgery provides~     an ideal model for a within patient evaluation of anti-scarring activity in wounds which~     develop into bad scars.~      This study is being undertaken to investigate the efficacy and safety of Juvista (given as an~     intradermal injection of 200ng per 1cm wound margin) in the reduction of scar appearance~     applied to approximated wound margins following bilateral reduction mammaplasty.~   "
238595|NCT00432315|"~     Primary objective:~      • To assess the response rate to induction therapy with docetaxel/CDDP.~      Secondary objectives:~      To assess~        -  Resectability after induction therapy~        -  Time to progression~        -  Overall survival~        -  Safety profile~        -  Quality of Life~   "
238596|NCT00432302|"~     The purpose of this study is to: a) Determine how the body takes up the test drug and~     distributes it into various body organs and tissues, how it processes the drug and how it~     ultimately removes it; and b) Examine how well the test drug works against cancer, and~     whether it is safe and tolerable to take~   "
238597|NCT00432289|"~     Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of~     Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a~     control protocol.~      Hypothesis: acupuncture treatment results in greater neurological recovery than a control~     treatment after an incomplete SCI.~      Before conducting a larger, more definitive study, this exploratory and developmental work is~     focused on assessing whether blinding is possible, reproducibility of the outcome measure,~     determine enrollment rates and effect sizes and identify clinical resources needed to conduct~     a larger study.~   "
238598|NCT00432276|"~     The purpose of the study is to compare the effect of adding alogliptin, once daily (QD), to~     the ongoing treatment regimen of pioglitazone HCl and metformin in patients with inadequate~     glycemic control.~   "
238599|NCT00432263|"~     To establish the effects of genotropin replacement in patients with severe growth hormone~     deficiency after traumatic brain injury on cognitive function.~   "
238600|NCT00432250|"~     The objective of this study was to investigate the effect of the use of sonographic cervical~     length (CL) on the hospital stay in women admitted because of preterm labor.~   "
238601|NCT00432237|"~     The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a~     placebo for acute migraine.~   "
238602|NCT00432224|"~     The objective of the study is to evaluate the use of sunlight instead of red light during~     photodynamic therapy of actinic keratoses using methyl aminolevulinate~   "
238603|NCT00432211|"~     This study is being undertaken to investigate the efficacy and safety of Juvista (given as an~     intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention~     or improvement of scar appearance when administered intradermally to approximated wound~     margins following surgical scar revision.~      In addition, this study will compare the scar revision techniques of complete excision~     (excision of the entire scar during one surgical procedure) and staged excision (excision of~     the outmost segments and central core separately).~   "
238604|NCT00432198|"~     To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized~     double blind-controlled trial~   "
238606|NCT00432172|"~     This is an open-label study that includes two substudies of random distribution. First,a~     sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical~     technique to determine several markers.Depending on the expression of these markers, the~     patients will be characterize as group 1 (Luminal A phenotype) or group 2 (Basal phenotype)~     and a random assignment will be performed to standard or experimental treatment.~   "
238607|NCT00432159|"~     This study is intended to treat patients with symptomatic degenerative disc disease at one~     level of the cervical spine. The patients will be randomized to the DISCOVER Artificial~     Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety~     and efficacy at 2 years post operative. Follow-up on patients treated with total disc~     replacement will be continued to 5 years post operative.~   "
238608|NCT00432146|"~     Context: Although some of endocrine surgeons administer Lugol's solution to decrease thyroid~     gland vascularity, there is still no agreement on its effectiveness.~      Objective: The aims of this clinical trial are to evaluate thyroid blood flow and microvessel~     density in the patients with Graves' disease according to the Lugol's solution treatment~     preoperatively.~      Design: Retrospective clinical trial. Setting: A tertiary referral center. Method: Thirty-six~     patients were randomly assigned to preoperative medication with Lugol's solution. Patients in~     group 1 (n=17) received Lugol's solution for 10 days before surgical intervention, whereas~     patients in group 2 (n=19) didn't receive it.~      Main Outcome Measures: Blood flow through the thyroid arteries of patients with Graves'~     disease was measured by color flow Doppler ultrasonography. The microvessel density (MVD) was~     assessed immunohistochemically and Western blot analysis using the level of expression of~     CD-34 in thyroid tissue. The thyroid gland's weight and blood loss were measured in all~     patients.~   "
238609|NCT00432133|"~     The focus of this study is to determine the mechanisms that underlie Physical Activity~     behavior change. We have 2 primary objectives. One, to test the effectiveness of brief,~     practical interventions to promote and maintain Physical Activity among individuals who are~     referred to a treadmill stress test but do not present symptoms of cardiac disease. Two, to~     test the potential individual and environmental mediators and moderators of this effect.~   "
238610|NCT00432120|"~     Clopidogrel pre-treatment before planned percutaneous coronary intervention was proved to~     reduce periprocedural complications. However, the vast majority of patients in the current~     interventional cardiology practice do not undergo planned PCI, but rather ad-hoc PCI~     performed immediately after coronary angiography . Whether clopidogrel should be administered~     as pre-treatment to all patients undergoing elective CAG with the aim to ensure therapeutic~     levels at the time of possible ad-hoc PCI is not known.~   "
238611|NCT00432107|"~     This phase II study is designed to determine the efficacy and safety of APO866 for the~     treatment of patients with advanced cutaneous melanoma. APO866 has shown to induce growth~     inhibition in cultures of human melanoma cells as well as in animal models with~     subcutaneously implanted melanoma tumors. APO866 was considered to be safe and well tolerated~     in a phase I study that treated 24 patients with advanced cancer. In that study one of the~     two patients with advanced melanoma had a stable disease for 5 months with size reduction of~     some lesions. APO866 is administered by intravenous infusion continuously for 96 hours that~     is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary~     efficacy endpoint will be assessed at Week 16. Patients will be follow-up for 12 months.~   "
238612|NCT00432094|"~     RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with~     metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor~     risk category or others who relapse can be successfully salvaged with high dose chemotherapy~     and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential~     high dose chemotherapy and AuSCT may improve overall and disease free survival.~      PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed~     patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose~     investigating how well non-cross resistant conditioning regimens work in treating patients~     with relapsed or high risk GCT.~   "
238613|NCT00432081|"~     The purpose of this study is determine whether indomethacin is able to retard disease~     progression in patients with mild to moderate Alzheimer's disease.~   "
238614|NCT00432068|"~     This study will assess the pharmacokinetic profile, safety and tolerability of an octreotide~     extended long-acting formulation after a single dose in humans. It will investigate the~     profile of a single dose of drug in a healthy volunteer subject in order to understand the~     timing and extent of fluctuations in octreotide concentrations in the blood with this~     formulation, the relationship of drug concentration with dose, and how long the drug remains~     in the body system.~   "
238615|NCT00432055|"~     The purpose of this project is to investigate if there is a significant difference in active~     joint range of motion, questionnaire on gait function and health related quality of life~     between patients randomized to treatment with Botulinum toxin type A and patients randomized~     to placebo treatment.~   "
238616|NCT00432042|"~     Primary Objective:~        -  To demonstrate that ProQuad® can be administered concomitantly with a booster dose of~          Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the~          antibody response rates to measles, mumps, rubella, varicella, hepatitis B and~          Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days~          following vaccination.~      Secondary Objectives:~        -  To describe the antibody titres and the antibody response rates to measles, mumps,~          rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and~          Haemophilus influenzae type b as measured at 42 days following vaccination by an~          Infanrix® hexa primary series schedule and all data are pooled.~        -  To evaluate the safety profile of ProQuad® when administered concomitantly with a~          booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data~          are pooled.~   "
238632|NCT00431821|"~     Regular exercise has been demonstrated to improve muscle strength, balance, coordination as~     well as improve cardiovascular fitness levels and overall quality of life in stroke~     survivors. This study is designed to test the feasibility and effectiveness of a 12-week~     intervention to education and encourage stroke survivors to exercise following discharge from~     rehabilitation settings using a walking program and targeted functional activity homework.~   "
238617|NCT00432029|"~     A couple of studies have shown that illuminating the eye with diffuse flickering light is~     accompanied by an increase of retinal vessel diameters, optic nerve head blood flow and~     retinal blood flow. We have recently used this visual stimulation technique as a new and~     powerful tool for the non-invasive investigation of vascular reactivity. Additionally, we~     could show that this response is diminished in patients with vascular pathologies and that~     the response is dependent on nitric oxide, indicating that flicker induced vasodilatation may~     reflect endothelial dysfunction and may be a new approach to test endothelial function in~     vivo.~      One of the most widely used method for the assessment of endothelial function is flow~     mediated dilatation (FMD). FMD has been shown to give a reliable estimate of vascular~     function in vivo. In the present study, we set out to compare the standard method for the~     evaluation of endothelial function, FMD, to flicker induced vasodilatation in the retina.~   "
238618|NCT00432016|"~     The purpose of this study is to determine the short term safety, tolerance, and antiviral~     effect of zidovudine (AZT) and amdoxovir (AMDX, DAPD) in combination, and whether the dosage~     for AZT can be reduced, potentially decreasing side effects, while maintaining antiviral~     effects.~      Study hypothesis: DADP in combination with AZT is safe and effective, and AZT dosing may be~     reduced, resulting in lower levels of AZT-monophosphate associated with toxicity and~     maintaining levels of AZT-triphosphate associated with efficacy.~   "
238619|NCT00432003|"~     The purpose of this study is to observe the way two different anti-HIV treatment strategies~     affect nerve and brain function in adults with HIV.~   "
238620|NCT00431990|"~     The purpose of the first phase of the study is to determine whether, and at what dose,~     depsipeptide, bortezomib and dexamethasone can be safely administered to patients with~     Multiple Myeloma. The second phase of the study will establish whether depsipeptide,~     bortezomib and dexamethasone is effective in the treatment of patients with multiple myeloma.~     The study will also examine the role of maintenance therapy with depsipeptide.~   "
238621|NCT00431977|"~     The purpose of this study is to evaluate the prevalence and clinical predictors of~     subclinical coronary atherosclerosis and to validate the usefulness of coronary CT~     angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.~   "
238622|NCT00431964|"~     This is a study to examine the safety, effect on lung function, and frequency of symptoms~     relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in~     6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa.~   "
238623|NCT00431951|"~     The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a~     single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30~     healthy, fed volunteers.~   "
238624|NCT00431925|"~     Mucositis and xerostomia are the most common complications of head and neck (H&N)~     irradiation, and the combination of chemotherapy and radiation therapy is associated with a~     significantly higher rate of complications.~      Mucositis usually develops during the second or third week of a course of standard~     radiotherapy, and the pain it causes peaks between the third and last week of treatment. The~     pain then persists for at least one month following the completion of therapy, and may be so~     overwhelming that it prevents patients from swallowing food and fluids. The patient is~     therefore at a risk to develop malnutrition, and must be treated vigorously. In this respect,~     the use of gastrostomy tubes (PEG) has been shown to be beneficial.~      Completion of the full course of irradiation, without interruption, is important for~     achieving best possible results in cancer of the H&N. It is therefore essential to identify~     and refer patients at risk to receive effective and timely nutritional intervention.~      Since mucositis represents a clinical continuum which differs between patients, it is~     difficult to assess before-hand which patients will be at risk.~      There is no simple laboratory tool available, which could predict which patients are~     susceptible to develop severe mucositis and dysphagia, and eventually will require a feeding~     gastrostomy.~      The first phase of mucositis, inflammation, results in the production of pro-inflammatory~     cytokines such as interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α).~      In general, the inflammatory cytokines IL-1, interleukin-6 (IL-6) and TNF-α are elevated in~     inflammatory conditions and are found in increased levels in blood and tissue fluid during~     inflammation, while anti-inflammatory cytokines are produced in a decreased manner.~      The main purpose of this study is to find the best indicators and prognosticators of~     mucositis occurring in the healthy oral tissues of H&N cancer patients receiving treatment,~     and to understand the cytokines balance mechanism of action.~      Assuming there is a correlation between high cytokines levels during inflammation and the~     severity of radiation induced mucositis, finding these prognostic factors may help us predict~     during the first part of the treatment the need for PEG, placing it prior to the~     complications associated with severe mucositis on one hand, and avoiding unnecessary~     procedures on the other hand.~   "
238625|NCT00431912|"~     This phase II study is designed to determine the efficacy and safety of APO866 for the~     treatment of patients with advanced forms of cutaneous T-cell lymphoma (CTCL). APO866 has~     shown to induce growth inhibition in cultures of human CTCL cells as well as in animal models~     with subcutaneously implanted human CTCL tumors. APO866 was considered to be safe and~     well-tolerated in a phase I study that treated 24 patients with advanced cancer. APO866 is~     administered by intravenous infusion continuously for 96 hours and that is repeated every 4~     weeks. Patients will receive 3 cycles of treatment and the primary efficacy endpoint will be~     assessed at Week 16. patients will be followed up for 12 months~   "
238626|NCT00431899|"~     The aim of the study was to determine the effects of a 3-week fish oil oral supplementation~     on the metabolic fate and thermogenic effect of an oral glucose load in hemodialysis~     patients.~   "
238627|NCT00431886|"~     The purpose of this study is to determine the usefulness of 64 slice multi-detector computed~     tomography as a first diagnostic approach in acute chest pain patients in emergency room~   "
238628|NCT00431873|"~     In this study, MGCD0103, a new anticancer drug under investigation, is given three times~     weekly to patients with refractory chronic lymphocytic leukemia.~   "
238629|NCT00431860|"~     The purpose of this study is to validate the usefulness of 64-slice multi-detecter computeted~     tomography as a screening tool in asymptomatic population.~   "
238630|NCT00431847|"~     The purpose of this study is to examine the short and long-term benefits of implementing~     early regional anesthesia techniques for pain control after a major traumatic injury to one~     or more extremities during combat in the Iraqi/Afghanistan war, including the effects on~     acute and chronic pain, quality of life, and mental health.~   "
238631|NCT00431834|"~     This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the~     outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery~     plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The~     trial population includes patients requiring valve replacements or repairs, atrial septal~     defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft~     (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate~     Surgical Ablation System can safely and effectively treat permanent AF patients.~   "
238633|NCT00431808|"~     This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen~     1 (PfAMA-1-FVO[25-545]) will be tested in malaria endemic populations. The phase Ib study~     will include adults who will be randomly allocated to either receive the malaria vaccine or~     the vaccine against Tetanus. Each participant will receive 3 immunizations, without the~     clinical investigators or the participants themselves knowing what has been given. They will~     then be follow-up up for immediate reactions to vaccination, and also over a longer term of~     one year. Blood will be taken to evaluate the biological safety parameters and also immune~     responses.~   "
238634|NCT00431795|"~     DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical~     utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to~     potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was~     designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy~   "
238635|NCT00431782|"~     The primary purpose of this study (CLN-504) is to determine the safety and develop a dosing~     regimen of an investigational anticoagulant drug (ATI-5923) in patients with atrial~     fibrillation.~   "
238636|NCT00431769|"~     The purpose of this study is to evaluate the safety and efficacy of bortezomib in~     participants with multiple myeloma who have previously responded to a bortezomib based~     therapy.~   "
238637|NCT00431756|"~     The purpose of this study is to determine if there are any early changes in DNA markers of~     blood and esophageal tissue in people with gastric reflux, Barrett's esophagus or esophageal~     cancer that can warn of a progression to esophageal cancer.~   "
238638|NCT00431743|"~     The investigators want to investigate the effects of two different kinds of fluid infusions~     given during varicose vein surgery. Both types of fluid are regularly given during surgery,~     and the investigators want to compare their respective effects on balance, nausea/vomiting~     and orthostatic function after surgery.~      The investigators' hypothesis is that using a colloid solution will improve orthostatic~     function, balance, nausea/vomiting and reduce hospital stay.~   "
238639|NCT00431730|"~     Habitual smoking is associated with an increased risk of coronary artery disease, cerebral~     and peripheral vascular disease, including ocular diseases like age-related macular~     degeneration or diabetic retinopathy. Data of a recent study performed in the investigators~     lab revealed abnormal choroidal blood flow regulation in chronic smokers as compared to~     age-matched non-smoking subjects during isometric exercise. However, no information is yet~     available about the regulation of retinal vascular tone in habitual smokers.~      Thus, in the current study, the investigators set out to investigate whether the regulation~     of retinal vessels diameters is affected in habitual smokers. It has been shown in several~     reports that stimulation with diffuse luminance flicker, increases retinal arterial and~     venous diameters, indicating for the ability of the retina to adapt to changing metabolic~     demands. In the current study we use this effect as a tool to investigate whether the flicker~     induced vasodilatation is affected in habitual smokers. This would indicate for an impaired~     vascular regulation process in smokers.~   "
238640|NCT00431717|"~     The purpose of this study is to compare the difference of diagnostic efficiency between~     coronary CT angiography and myocardial perfusion single photon emission computerized~     tomography in asymptomatic patients with type 2 diabetes mellitus.~   "
238641|NCT00431704|"~     The purpose of this study is to evaluate the activity and safety of the combination of~     vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.~   "
238642|NCT00431691|"~     Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates,~     has been implicated in many disease processes, especially age-related disorders. Many trials~     investigating use of antioxidants in protecting different tissues against oxidative stress~     have been conducted, but the results are ambiguous.~      Inflammation is generally associated with enhanced oxidative stress and widespread~     endothelial dysfunction. In the present study, the infusion of LPS, which is a cell wall~     component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock,~     will be used as a standardized experimental model of systemic inflammatory response in~     humans. The assessment of outcome parameters will include measurements of ocular blood flow,~     forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics~     provide an unique chance to investigate local blood flow in humans non-invasively. Moreover,~     the retina is especially susceptible to oxidative stress because of its high consumption of~     oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light.~     Evidence from literature clearly supports a role for oxidative stress in pathophysiology of~     several ocular diseases including diabetic retinopathy and age-related macular degeneration.~     To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus.~     The measurement of forearm blood flow will be use to assess endothelial function. The main~     study objective is to investigate the effect of oral vitamins and minerals supplementation on~     impaired retinal vascular reactivity after LPS administration.~   "
238643|NCT00431678|"~     Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in~     17 countries to determine if this treatment regimen is safe and effective in treating~     hospitalized adult patients with community-acquired pneumonia. 748 patients were participated~     in the study over an 18 months period. Individual patient involvement in the study was~     approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high~     dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose~     oral levofloxacin.~   "
238664|NCT00431392|"~     There is evidence from a variety of animal studies that choroidal blood flow is under neural~     control. By contrast, only little information is available from human studies. Recent results~     indicate that a light/dark transition is associated with a short lasting reduction in~     choroidal blood flow. We have shown that during unilateral dark/light transition both eyes~     react with choroidal vasoconstriction strongly indicating a neural mechanism.~      The present studies investigate this possibility by using pharmacological interventions. The~     pharmacological agents tested include a nitric oxide synthase inhibitor, an alpha-receptor~     agonist (as a control substance for the blood pressure increasing nitric oxide synthase~     inhibitor), a muscarinic receptor blocker, and a non-specific beta-blocker. These drugs were~     chosen on the basis of previous animal experiments, as the systems, which are specifically~     influenced by these substances, are likely involved in neural control of choroidal blood~     flow.~   "
238644|NCT00431665|"~     Type 2 diabetes is frequently associated with elevation of plasma-free fatty acids (FFA).~     Studies indicate that elevation of plasma-FFA induces insulin resistance and also causes~     endothelial dysfunction as well as hemodynamic changes which are supposed to be involved in~     the pathogenesis of diabetic vascular disorders.~      Glomerular hyperfiltration, which is associated with glomerular hypertension and hypertrophy,~     a common finding in the early course of type 1 diabetes as well as type 2 diabetes, plays an~     important role in the development and progression of diabetic nephropathy. These hemodynamic~     changes are not well understood, but are most likely induced by dilatation of the~     (precapillary) glomerular arteriole.~      In humans the hemodynamic effect of FFAs has so far been investigated locally in brachial and~     femoral arteries and recently in the eye and skin, where FFAs induced a pronounced increase~     in blood flow probably due to a local decrease in vascular resistance.~      The aim of the present study is to characterise the hemodynamic effects of FFAs in the~     kidney. In addition we want to test the hypothesis that FFA-induced changes are mediated via~     endothelial derived nitric oxide (NO). The results of this study could provide information to~     what extent elevated FFA-plasma levels contribute to hyperfiltration in the early course of~     diabetes mellitus. The measurements will be done at baseline and during 4 hour infusion of a~     triglyceride or placebo infusion, combined with heparin.~   "
238645|NCT00431639|"~     This study will examine how animal-assisted therapy (AAT) affects aspects of pain. It will~     explore the possible benefits of the National Institutes of Health's AAT program on distress~     in cancer patients receiving pain and palliative care at the NIH Clinical Center. A number of~     studies on the benefits of patients interacting with companion animals have shown a positive~     effect of both pet ownership and AAT for patients with chronic illness. However, few such~     experimental studies have been conducted with cancer patients.~      Patients 18 years of age and older who have been diagnosed with cancer and have been referred~     for consult with NIH's pain and palliative care team and recreation therapy may be eligible~     for this study.~      Participants have two study sessions, each lasting about 20 minutes on two different days. In~     one session, they visit with an animal assistant therapy dog and its handler. In the other~     session they engage in a conversation that the patient identifies as non-stressful. Patients~     are asked to fill out four forms before and after each session with questions and statements~     about their pain, attitude towards pets, symptoms they might be having, and demographic~     information, such as age, sex, marital status, and so forth. On four separate occasions, 1~     teaspoon of blood is drawn and a swab of saliva is collected from the mouth up to an hour~     after the session.~   "
238646|NCT00431626|"~     The purpose of this research study is to determine if the study drug Dutasteride taken before~     and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and~     safe, long term improvement of lower urinary tract symptoms.~   "
238647|NCT00431613|"~     The combination of chemotherapy with radiotherapy remains the standard of therapy for~     patients with stage III NSCLC. A recent phase II study has presented encouraging data~     regarding the administration of docetaxel as consolidation treatment after definitive~     concurrent chemo-radiotherapy.~   "
238648|NCT00431600|"~     Noninvasive monitoring of blood flow in retinal circulation may elucidate the progression and~     treatment of ocular disorders, including diabetic retinopathy, age-related macular~     degeneration and glaucoma.~      Laser Doppler velocimetry (LDV), a noninvasive optical method combined with vessel size~     determination has been used extensively as a valuable research tool to examine blood flow~     dynamics in the human retina. However, no information on the velocity profile within the~     vessel is available. Ophthalmic color Doppler optical coherence tomography (CDOCT) provides~     laser Doppler information in addition to conventional optical coherence tomography, allowing~     the observation of blood flow dynamics simultaneously to imaging retinal structure.~      We have recently demonstrated the feasibility of Fourier domain CDOCT to assess velocity~     profiles in human retinal vessels in vivo.~      In the present study the validity of Fourier domain CDOCT for retinal blood flow measurements~     will be tested at baseline and during hyperoxia-induced vasoconstriction in humans by~     comparison with retinal blood flow measurements using a commercially available LDV system and~     the Zeiss retinal vessel analyzer (RVA)~   "
238649|NCT00431587|"~     The metabolic risks associated with obesity are closely correlated with central (abdominal),~     rather than a peripheral (gluteofemoral) fat pattern It has been shown that weight loss after~     bariatric surgery is followed by metabolic improvements.~      The amount of fat lost from each site may be independently regulated. Very scant information~     is found in the literature regarding the relative changes in different fat body compartments,~     and their effect on the improvement of the metabolic profile.~      In this study we define the absolute and relative changes in the different adipose tissue~     compartment after weight loss surgery~   "
238650|NCT00431574|"~     In patients stabilized on their antipsychotic and demonstrating evidence of good clinical~     response, there will not be a significant change in symptoms if their medication is decreased~     to every 2 days rather than daily. This decrease in antipsychotic exposure will lead to a~     reduction in side effects, as well as improved subjective response to treatment.~   "
238651|NCT00431561|"~     In this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP~     12009 compared to standard chemotherapy (temozolomide or PCV) is investigated in adult~     patients with confirmed recurrent high-grade glioma.~   "
238652|NCT00431548|"~     Ocular lesions, including cotton wool spots and retinal hemorrhage, are a common feature of~     HIV infection and acquired immunodeficiency syndrome (AIDS). The aetiology of these~     apparently vasoocclusive phenomena in HIV related retinopathy is not well understood. Several~     hypotheses including infectious damage of the retinal vasculature and altered retinal~     hemodynamics have been postulated. The latter would be compatible with the theory that the~     retina of HIV patients is hypoxic. However, direct measurement of oxygen tension in the~     retina is not possible and indirect methods have to be employed. The study objective was to~     investigate the reactivity in retinal blood flow to 100% oxygen breathing in patients with~     HIV.~   "
238653|NCT00431535|"~     It is the purpose of the investigators to investigate the possible relationship between fall~     in the amount of Oxygen in the blood and disturbances of balance-function before and after~     surgery.~   "
239512|NCT00420082|"~     This is a randomized, double blind, active and placebo controlled, 4 way crossover study in~     patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20~     mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.~   "
238654|NCT00431522|"~     -  To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA)~          levels in patients with bipolar disorders who are within euthimic, depressive or~          manic/hypomanic period and who are not taking drug;~        -  To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on~          total and local gray matter volumes and NAA levels.~        -  To measure the brain electrical response to visual and auditory impulses before and~          after valproate treatment in patients within euthimic, depressive or manic/hypomanic~          period and who are not taking drug, and to compare the data with each other and with~          normal groups.~        -  To determine the cognitive functions before and after the valproate treatment in the~          same patient group, to compare the data with each other and with age- and sex-paired~          normal controls;~        -  To determine the relationship between these effects of valproate and clinical~          improvement;~        -  To investigate the relationship between cognitive ability status and electrical activity~          of brain, to compare this with that in control group; to determine the relationship~          between the data and brain imaging (MRI/MRS) findings in conjunction with localization~   "
238655|NCT00431509|"~     This study is undertaken to investigate the effect of navigated knee implantation surgery on~     physical function, joint stiffness, pain, quality of life and coordinative abilities.~      One group of patients will receive navigated knee implantation surgery, the other traditional~     knee implantation surgery, without use of the navigation system.~      The study is designed as a randomized trial. That means that all patients who have given~     their consent to participate in this study will be allocated to either navigated or~     conventional surgery by chance.~      A total of 477 patients will be included in this study and will be followed up for 12 month.~      In this period all patients will be asked to fill in functional and quality of life~     questionnaires at baseline, 6 weeks and 3, 6 and 12 month follow-up. Coordinative abilities~     will be evaluated once in the time-frame 3 to 6 months postoperatively.~   "
238656|NCT00431496|"~     The purpose of this study is to show that the use of cinacalcet in patients with End Stage~     Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium~     phosphorous product.~   "
238657|NCT00431483|"~     The purpose of this study is to establish the impact of a pharmacist's recommendations~     regarding choice, dosing and duration of antibiotic therapy on quality and cost of antibiotic~     treatment on surgical wards.~   "
238658|NCT00431470|"~     Through the use of an educational intervention, the object of this study is to reduce the~     prevalence of bullying behaviors among fifth grade school age children. Bullying behaviors~     promote an environment of violence , fear, and hostility. The study will arrange to present~     six character education lessons in the classroom of fifth grade students in a New York City~     public school. Questionnaires will be administered to the students before and after all the~     lessons have been completed. Questionnaires will collect information about the students self~     perception of their levels of misconduct, impulsivity, confidence, value of non violence,~     ways of handling anger, opinions of their leadership behaviors, prevalence of bullying~     behaviors, and indications of levels of self esteem. Also, their fifth grade teachers will~     complete pre and post treatment student behavioral questionnaires.~   "
238659|NCT00431457|"~     Patients will be prospectively randomized to 3 different treatment arms:~        -  Treatment group 1: patients who undergo medial temporal lobe resection~        -  Treatment group 2: patients who receive immediate hippocampal neurostimulation~        -  Treatment group 3: patients who are implanted with an intracranial electrode but in whom~          hippocampal neurostimulation is delayed for 6 months.~      Twelve months after inclusion unblinding will occur. Patients in group 2 and 3 will have the~     option to choose between continuing neurostimulation treatment or resective surgery.~      Study visits will occur every 3 months.~   "
238660|NCT00431444|"~     This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone~     turnover markers in postmenopausal women with low bone mineral density over 6 months.~   "
238661|NCT00431431|"~     Both tibolone and raloxifene have been demonstrated to prevent postmenopausal bone loss.~     During treatment with tibolone bone mineral density (BMD) of the spine has been shown to be~     increased between 1.8 and 5.8 % above baseline in two years, depending on the population~     studied. Since treatments aimed at prevention should ideally be used long-term, compliance~     with the treatment is crucial. Efficacy of and compliance with the two treatments will be~     measured and evaluated.~   "
238662|NCT00431418|"~     The purpose of this pilot study is to investigate in a randomised double-blind trial whether~     treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at~     28 weeks of gestation or less.~   "
238663|NCT00431405|"~     Rheumatoid arthritis (RA) is a symmetric, peripheral polyarthritis of uncertain etiology that~     can lead to joint deformity and destruction. However, the effects of RA are not confined~     simply to joint involvement. Virtually every organ system can be affected by RA if left~     untreated. Of particular note is RA’s affect on the cardiovascular system. RA patients have a~     reduced lifespan compared to the general population primarily due to an increased~     cardiovascular disease burden (1). Recently, RA has been linked to the development of~     preclinical atherosclerosis in the carotid arteries as measured by ultrasonography (2). Women~     with RA have also been shown to have an increased incidence of nonfatal myocardial~     infarctions (3). Despite these studies showing the effects of RA on the cardiovascular~     disease burden of those who are afflicted, no study to date has compared the number of~     cardiovascular events in a large RA patient population to a risk factor and age matched~     control group. Consequently it is the goal of this study to determine whether the~     cardiovascular event ratio in an RA patient cohort exceeds an age and risk factor matched~     cohort of non-RA patients. This study will also attempt to ascertain whether specific~     cardiovascular risk factors contribute to the cardiovascular morbidity and mortality~     associated with RA and if any standard cardiovascular medicines disproportionately contribute~     to patient outcome.~      Hypothesis: Given the increased cardiovascular disease burden associated with RA patients~     they are likely to suffer from a statistically significant increased risk of cardiovascular~     events when compared to an age and risk factor matched cohort.~   "
238692|NCT00431028|"~     The purpose of this study is to compare one intraoperative sub-Tenon's capsule injection of~     triamcinolone and ciprofloxacin in a biodegradable controlled-release system with~     conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for~     infection prophylaxis after cataract surgery.~   "
238665|NCT00431379|"~     The pathogenesis of ARDS appears to be from damage to the alveolar-capillary barrier, which~     is composed of the microvascular endothelium and the alveolar epithelium. This damage may~     occur from direct or indirect lung injury. The mechanism of injury to the alveolar capillary~     barrier appears to be through neutrophil-mediated injury, pro-inflammatory cytokines,~     ventilator-induced lung injury with alveolar over distention and abnormalities of the~     coagulation system. This results in blood clot formation in the microcirculation of the lung.~     Thrombolytics can dissolve blood clots and result in increased blood flow to the organs. This~     treatment may benefit ARDS patients, thus the purpose of this study.~      Hardaway, et al.studied the effects of thrombolytics on ARDS in pigs. The experimental group~     showed improved oxygenation and survival as compared to controls. There was no bleeding~     complications noted with this therapy. Dr. Hardaway followed this animal study with a phase I~     clinical trial involving 20 patients with ARDS. The patients were treated with IV~     streptokinase or urokinase. Nineteen of the 20 patients showed an increase in PA02 after~     thrombolytic therapy. There were no significant bleeding complications in patients that were~     critically ill on ventilators.~      We propose an additional phase I pilot study to evaluate the effectiveness and safety of~     Tenecteplase for the treatment of ARDS. Unlike the other fibrinolytics studied in this~     disease state, Tenecteplase, is more fibrin specific and has increased resistance to~     plasminogen activator inhibitor (PAI-I) at greater levels than other available fibrinolytics.~     We have chosen an experimental dose escalation trial design of tenecteplase that has~     demonstrated initial safety trends in a Phase I acute ischemic stroke trial. The initial dose~     is 0.1 mg/kg IV and will increase to 0.2 mg/kg, 0.3 mg/kg, with a final cohort of patients~     receiving 0.4 mg/kg. Drug administration will be a single dose bolus in each cohort.~     Advancement of dose will occur if safety is not in question in the previous cohort. We hope~     this will provide an acceptable benefit risk ratio as the mortality of ARDS is approximately~     30 - 60%. All patients will be closely monitored for any change in clotting parameters and~     signs of bleeding. Tenecteplase will be administered via a peripheral IV as described in the~     package insert.~   "
238666|NCT00431366|"~     This study will explore sequence effect, a fatigue or tiredness commonly seen in patients~     with Parkinson's disease after they have been doing the same thing for a while. The study~     will use a new device called a modified peg board test (see description below) to measure~     whether antiparkinsonian medications (levodopa/carbidopa or dopamine) and repetitive~     transcranial magnetic stimulation (rTMS, see description below) of the brain can improve the~     symptoms of sequence effect.~      Patients with early-stage Parkinson's disease who have never taken antiparkinsonian~     medications and patients with advanced disease may be eligible for this study. Candidates~     must be 18 years of age or older and right-handed.~      Participants have five visits to the NIH Clinical Center as follows:~        -  Visit 1 (baseline): Patients have a neurological examination, including brief cognitive~          function tests, a rating for depression, and two types of ratings for fatigue severity.~        -  Visits 2 through 5 (experimental sessions): Patients who have been taking antiparkinson~          medication for a long time are asked to not take their medication for about 12 hours~          (overnight withdrawal) before visits 2 through 5. They are off medication for about 14~          hours total (until after the experiments are done). Patients may be admitted to the NIH~          Clinical Center for the overnight drug withdrawal if necessary. At the start of each~          session, participants are given either levodopa/carbidopa tablets or placebo (tablets~          identical in appearance but with no active medication). They perform the modified~          pegboard test before medication, after medication, and after brain stimulation with~          rTMS. During two of the sessions, they receive actual brain stimulation, and during the~          other two sessions they receive sham stimulation, which does not actually stimulate the~          brain.~      The modified pegboard test is a computer-based machine with eight pegs. Subjects transfer~     each peg from a line of holes on the right side to a line of holes on the left side using~     their right hand and moving as quickly as possible. After they finish moving all pegs to the~     left line of holes, they wait for a beep and then transfer the pegs from left line to right~     line of holes. They do this six times, three times with their right hand and three times with~     their left.~      rTMS involves repeated magnetic pulses delivered in trains or short bursts of impulses. A~     brief electrical current is passed through a wire coil held on the scalp. The current creates~     a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling~     sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or~     leg. During the stimulation, the subject may be asked to tense certain muscles slightly or~     perform other simple actions. The effect of TMS on the muscles is detected with small metal~     disk electrodes taped onto the skin of the right hand. Subjects receive four rTMS blocks per~     10 minutes. Each block consists of a total of 375 pulses.~   "
238667|NCT00431353|"~     This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with~     intravenous ganciclovir for the treatment of CMV disease in solid organ transplant~     recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or~     2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the~     target sample size is 100-500 individuals.~   "
238668|NCT00431340|"~     This open-label study will assess anti-tumor activity and safety of belinostat in combination~     with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at~     least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and~     bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.~   "
238669|NCT00431327|"~     To identify patients at risk for nonattendance to their first scheduled colonoscopy and to~     conduct a randomized trial of a theory-based, peer coach intervention on completing the~     scheduled colonoscopy.~   "
238670|NCT00431314|"~     The aim of this study is to determine the vascular condition of hemodialysis patients with~     toe pressure measurement, finger pressure measurement and measuring glycated and oxidated~     proteins by skin autofluorescence.~      Hypothesis: Lowering of finger pressure/toe pressure during hemodialysis, especially in whom~     with a arteriovenous fistula, may contribute to critical limb ischemia in the extremities.~   "
238671|NCT00431301|"~     Progressive supranuclear palsy (PSP) is the most common atypical parkinsonian movement~     disorder. This study will determine the role of specific genetic, occupational and~     environmental components in the development of PSP by evaluating patients with this disorder~     and age and gender matched controls.~   "
238672|NCT00431288|"~     The purpose of this study is to evaluate the efficacy of a 12-week, clinic-based, behavioral~     nutrition intervention emphasizing fruits, vegetables, and low fat dairy compared to routine~     nutrition care on changing dietary knowledge, self-efficacy, diet quality and blood pressure~     post-treatment and at short-term follow-up in adolescents with hypertension.~   "
238673|NCT00431275|"~     This is an open-label, 2-arm study in which patients are randomized to receive either the~     formulation that is being used in clinical trials or the formulation that will be used when~     if the drug becomes commercially available. The purpose of this study is to compare the~     pharmacokinetics of the two formulations.~   "
238674|NCT00431262|"~     Newly detoxified alcoholics (N=60) are randomised to either antabuse (disulfiram) treatment~     or the control group for a total of 6 months.All patients will receive cognitive behavioural~     treatment in groups. The hypothesis to be tested is that more of the patients who receive~     antabuse (disulfiram) will be alcohol free during the 6 months treatment period compared to~     the control group. The trial is open.~   "
238693|NCT00431015|"~     The purpose of this study is to determine the safety, tolerability and maximum tolerated dose~     of IPI-504 in patients with non-small cell lung cancer (NSCLC). The study will examine how~     IPI-504 is absorbed, distributed, metabolized and eliminated by the body. The study will also~     evaluate the anti-tumor activity of IPI-504.~   "
238694|NCT00431002|"~     The main purpose of this study is to investigate the effect of two different group-based~     exercise programs on fall risk (muscular strength and balance) and bone strength in older~     women aged over 65-75 years who have low bone mass. We are also trying to determine if once a~     week exercise is as effective on health outcomes as twice a week. We hypothesize that twice a~     week exercise will be more effective than once a week or sham exercise.~   "
238675|NCT00431249|"~     Peripheral arterial disease (PAD) is the most common manifestation of systemic~     atherosclerosis and accounts for significant morbidity and mortality among end-stage renal~     disease (ESRD) patients. However, few studies have identified the prevalence and clinical~     impact of PAD in this specific population.~      Objectives: To perform a single-blinded parallel, controlled trial to examine the effect of~     cilostazol treatment on plasma VEGF levels, tissue factors , inflammatory markers (such as~     IL-6, hsCRP) levels, oxidative stress markers in ESRD patients with PAD Material and methods~     Fourty HD patients on maintenance HD for > 3months were enrolled in this prospective,~     single-blinded, randomized study. These patients were randomly allocated into 2 arms. After~     baseline assessment, patients in the treatment arm received 12 weeks of added on therapy with~     cilostazol 100mg/day. Blood pressure, heart rate, oxidative stress (malonyldialdehyde,~     protein carbonyl and ADMA), inflammatory markers (hsCRP, IL-6) and plasma, VEGF and tissue~     factors levels were measured before and after treatment.~   "
238676|NCT00431236|"~     This is a Phase III trial designed to demonstrate that casopitant when added to dexamethasone~     and ondansetron is more effective in the prevention of vomiting then dexamethasone and~     ondansetron alone, in patients who receive a cisplatin-based highly emetogenic chemotherapy.~   "
238677|NCT00431223|"~     This project is a novel exploratory research project to investigate changes in activation~     patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who~     received a 12-week computerized cognitive remediation (CRT) program. The hypothesis is that~     patients receiving CRT will show greater increase in activation patterns in the brain as~     compared to controls, and the degree of brain activation will correlate with improvements in~     working memory.~   "
238678|NCT00431210|"~     The purpose of this study is to determine the safety of making and giving Epstein-Barr virus~     (EBV) immunotherapy products to subjects with nasopharyngeal carcinoma (NPC) associated with~     EBV that has come back or spread to other parts of the body. EBV immunotherapy product is~     made with white blood cells from the participants body that are collected intravenously. This~     EBV immunotherapy product may stop cancer cells from growing abnormally. EBV immunotherapy~     products have been used in several research studies for NPC. Information from these studies~     suggests the EBV immunotherapy products may stop the growth of NPC in some subjects.~   "
238679|NCT00431197|"~     This study is being done to learn how the male hormone , testosterone, affects pituitary~     hormones in younger and older men. The pituitary is a gland in the brain that secretes~     hormones, some of which normally control growth and fertility.~   "
238680|NCT00431184|"~     Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals.~     To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind~     study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases~     manic symptoms.~   "
238681|NCT00431171|"~     The current study is a phase I open-label clinical trial to examine plasma levels after oral~     lithium treatments in 20 subjects with chronic spinal cord injury. The subjects will receive~     standard doses of oral lithium used in treatment of manic depression. The goal of the trial~     is to show feasibility and safety of maintaining plasma levels of 0.6 mmol/L to 1.2 mmol/L~     for six weeks in subjects with chronic spinal cord injury.~   "
238682|NCT00431158|"~     Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is~     provided by a machine called a ventilator or respirator. The purpose of this study is to find~     out if a new method of setting the ventilator for patients with severe ARDS is better than~     the standard, commonly used way of setting the ventilator.~   "
238683|NCT00431145|"~     Aim of the study is to show additional effects of the combined therapy of niacin and statins~     analyzing number and function of EPCs and other stem cell populations and adiponectin as well~     as hsCRP levels in patients with CAD.~   "
238684|NCT00431132|"~     This trial is conducted in Europe. The purpose of this study is to evaluate endometrial~     safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic~     vaginitis.~   "
238685|NCT00431119|"~     To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine~     or mycophenolate mofetil for the treatment of bullous pemphigoid.~   "
238686|NCT00431106|"~     The combination of vinorelbine and gemcitabine seems to be an important part of the~     chemotherapy regimens used in metastatic breast cancer patients following treatment failure~     with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in~     metastatic breast cancer patients following treatment failure with the combination of a~     taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens~     used in metastatic breast cancer patients. Whether the combination of vinorelbine and~     gemcitabine or capecitabine administration is preferable is not yet known, especially in~     patients with metastatic disease.~   "
238687|NCT00431093|"~     The present trial is undertaken to compare the effects of Tibolone with a low-dose HRT~     regimen.~   "
238688|NCT00431080|"~     Anthracycline-containing regimens are recommended as adjuvant treatment for women with node~     positive breast cancer. In at least three large randomized clinical trials the addition or~     sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based~     regimen resulted in superior clinical outcome for women with node positive early breast~     cancer. In two large randomized studies the dose dense administration with G-CSF support of~     anthracycline-based and paclitaxel combination was superior to the same regimen administered~     every three weeks without growth factors as adjuvant therapy in women with axillary node~     positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel~     in women with metastatic breast cancer~   "
238689|NCT00431067|"~     The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive~     metastatic breast cancer patients after failure of trastuzumab containing regimens.~   "
238690|NCT00431054|"~     The goal of this clinical research study is to find out if a combination treatment of~     perifosine and docetaxel will help shrink or slow the growth of cancer cells in recurrent~     ovarian cancer. The safety of this combination treatment will also be studied.~   "
238691|NCT00431041|"~     The purpose of this study is to compare the safety and efficacy of solifenacin with~     oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).~   "
238695|NCT00430989|"~     To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors~     for coronary artery disease undergoing major surgery.~   "
238697|NCT00430963|"~     IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing~     proteins, i.e. free of proteins other than the active toxin. Injected into the muscle,~     IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used~     for aesthetic treatment of facial lines. This study investigated the efficacy and safety of~     IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo.~     The study consisted of a Main Period and an Open-Label Extension [OLEX] Period of 120 days~     each.~   "
238698|NCT00430950|"~     The study will evaluate the blood pressure lowering effects of two different dosages of the~     combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high~     blood pressure.~   "
238699|NCT00430937|"~     This study evaluated the efficacy and safety of daptomycin compared to vancomycin or~     teicoplanin for the treatment of complicated skin and soft tissue infections~   "
238700|NCT00430924|"~     The purpose of this study is to examine whether the inhibition of aldosterone will result in~     lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered,~     progression of renal disease with be slower than otherwise expected.~   "
238701|NCT00430911|"~     A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or~     older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma,~     and a Karnofsky performance status > 70.~   "
238702|NCT00430898|"~     The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two~     levels of intravenous basiliximab in ulcerative colitis, compared to placebo.~   "
238703|NCT00430885|"~     The instigators hypothesize that IVIG, given in the acute phase following MI in patients at~     risk for developing HF, will improve cardiac performance, and by attenuating cardiac~     remodeling in this phase, such therapy will prevent the development of chronic HF resulting~     in long term beneficial effect also after the therapy has been stopped.~   "
238704|NCT00430872|"~     The goal of this research study is to learn the severity of certain symptoms in patients with~     tumors of the spine or spinal cord. Researchers also want to learn if the M. D. Anderson~     Symptom Inventory-Spine is a good way to rate these symptoms.~      Primary Objective:~      1. To evaluate the psychometric properties of the MDASI-Spine in patients with tumors~     involving the spine or spinal cord.~      Secondary Objective:~      1. To describe the severity of commonly occurring symptoms experienced by persons with spine~     tumors.~   "
238705|NCT00430859|"~     Eligible patients will receive either AP or matching placebo in a double blind, randomized~     design and following a 2:1 ratio. All medication will be given in addition to standard care~     for sepsis patients. Patients will be followed for 28 days after the start of study~     medication administration. A blinded safety review of the study results will take place after~     the inclusion of 12 patients in the study.~   "
238706|NCT00430846|"~     Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in~     patients with relapsed/refractory CD30-positive hematologic malignancies. This is a~     single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK,~     immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory~     CD30-positive hematologic malignancies.~   "
238707|NCT00430833|"~     The primary hypothesis of the study is that treatment with AT1-R antagonist in patients with~     nonobstructive form of HCM will be first save, second will cause regression of myocardial~     hypertrophy.~   "
238708|NCT00430820|"~     The study hypothesis is that differential proteomic techniques can be used to discover new~     circulating biomarkers of coronary atherosclerosis in the blood of patients suffering from~     coronary artery disease (either stable or unstable) who will be compared to a group of~     patients without coronary artery disease~   "
238709|NCT00430807|"~     Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its~     ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory~     drug that may have a corticosteroid sparing potential according to immuno-pharmacological and~     clinical data. We have designed a multcentric double blind versus placebo randomized~     controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non~     complicated giant cell arteritis.~   "
238710|NCT00430794|"~     To determine the efficacy of the addition of spironolactone to modern blood pressure lowering~     treatment regimens in patients with resistant hypertension (whose blood pressure is~     uncontrolled despite three blood pressure lowering drugs)~   "
238711|NCT00430781|"~     This study is being conducted to compare the efficacy and safety of pazopanib in combination~     with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic~     cervical cancer~   "
238712|NCT00430768|"~     Individuals with a deficiency of the alpha 1-antitrypsin (AAT) protein are at risk for~     developing emphysema and liver damage. Researchers have developed a way to introduce normal~     AAT genes into muscle cells with the expectation that the AAT protein may be produced at~     normal levels. This study will evaluate the safety of the experimental gene transfer~     procedure in individuals with AAT deficiency. The study will also determine what dose may be~     required to achieve normal levels of AAT.~   "
238713|NCT00430755|"~     Aim:~      To investigate the quality of history taking by physician and computer-based system.~      Patients:~      100 inpatients presenting at the RBK for the first time and treated in the departments of~     nephrology and cardiology.~      Methods:~      The information obtained by the computer based system is compared with the information~     acquired by conventional history taking. Study endpoint is the comparison of historical data~     organized according to the elements in a standard medical history on a patient-by-patient~     basis.~      Study procedure History taking is performed by physicians according to the guidelines of the~     RBK. Within 2 days thereafter the patient is interviewed with help of the CLEOS system with~     the support of a study nurse.~   "
238714|NCT00430742|"~     A worldwide study with extension in patients with type 2 diabetes mellitus to assess the~     safety and tolerability as well as the effects of treatment with an investigational drug for~     weight loss on body weight.~   "
238715|NCT00430729|"~     The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on~     exacerbation rate and pulmonary function as well as quality of life in patients with chronic~     obstructive pulmonary disease (COPD).~   "
238716|NCT00430716|"~     To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment~     of subjects with PAH.~   "
238717|NCT00430703|"~     The aim of this study is to determine whether passive gait training increases arousal,~     demonstrated as changes in EEG (electroencephalogram) activity.~      Hypotheses: 1) Passive gait training increases EEG-frequency in patients with impaired~     consciousness due to severe traumatic brain injury.~      2) Passive gait training increases conductivity speed of the cognitive P300-component of ERP~     in patients with impaired consciousness due to severe traumatic brain injury.~   "
238718|NCT00430690|"~     Chronic cocaine administration leads to changes in brain function that persist long after the~     acute withdrawal phase. The acoustic startle response (ASR) is a well characterized reflexive~     response to a sudden acoustic stimulus. The ASR is mediated by a simple 3-synapse subcortical~     circuit; it is modulated in part by brain areas and neurotransmitters associated with cocaine~     administration. Our initial study and subsequent replication reveals a profound diminution of~     the ASR in cocaine-dependent subjects after a brief period of abstinence. Our preliminary~     findings indicate that first degree relatives of cocaine-dependent subjects also have reduced~     startle compared to healthy controls. The findings of low ASR in rats and humans during~     cocaine washout and low ASR in family members suggests there may be both a trait and state~     component of the startle reductions we have reported.~      The central objectives of this proposal are to dissect this finding with regard to its~     development and persistence in early and later phases of cocaine abstinence in humans; to~     ascertain whether startle reduction and its potential normalization during later abstinence~     is a predictor of clinical course in human subjects with cocaine dependence; and to examine~     whether startle reduction is, at least in part, a vulnerability trait for the development of~     cocaine dependence. This latter Aim will be carried out in humans by testing siblings of~     cocaine-dependent subjects.~      Cocaine dependence is an enormous public health problem. The significance of this work lies~     in the potential for the ASR reduction to serve as a reliable, easily repeatable biological~     measure of cocaine-induced brain changes that may enhance outcome prediction so that tailored~     treatments may be directed at those patients most vulnerable to relapse, given the~     restriction of resources for available for substance abuse treatment.~   "
238719|NCT00430677|"~     The purpose of this clinical research study is to learn if addition of abatacept is safe and~     improves the effectiveness of treatment of patients with active lupus nephritis who are also~     taking mycophenolate mofetil (MMF) and corticosteroids.~   "
238720|NCT00430664|"~     Pleurodesis is a technique used to fuse the two layers of the lining over the lung. This is~     done to get rid of collections of fluid or air in this space. A common reason would be cancer~     of the underlying lung or elsewhere causing fluid to collect in the pleural space. In this~     situation it is a palliative procedure to free the patient from symptoms like breathlessness.~   "
238721|NCT00430651|"~     This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second~     line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated~     previously with Docetaxel.~   "
238722|NCT00430638|"~     This 16 week study will examine the ability of olmesartan medoxomil to lower the blood~     pressure of patients with moderate to severe high blood pressure in comparison to placebo.~     The medication being tested has been approved by the FDA for the treatment of high blood~     pressure.~   "
238723|NCT00430625|"~     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme~     glucocerebrosidase (GCB). Due to this deficiency of functional GCB, glucocerebroside~     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ~     system dysfunction. The purpose of this study is to evaluate the efficacy of every other week~     dosing of Gene-Activated® Human Glucocerebrosidase (GA-GCB, velaglucerase alfa) at doses of~     45 and 60 U/kg in treatment-naïve patients with type 1 Gaucher disease.~   "
238724|NCT00430612|"~     The purpose of the PACE-MI (OBTAIN) registry is:~        -  Analyze beta-blocker dose response effect on outcome over two years~        -  Explore gender and minority differences in beta-blocker utilization and outcomes.~      In patients with Myocardial Infarction (MI) discharged from the hospital, beta-blocker dose~     will be predictive of survival.~      Exploratory analyses: Gender and racial effects—gender and race are, similarly, hypothesized~     to be predictive of post-MI survival.~      The existence of interactions between gender and beta-blocker effect as well as race and~     beta-blocker effect will also be evaluated.~   "
238725|NCT00430599|"~     We are carrying out this study to determine whether Keppra (a drug usually used to treat~     epilepsy) is an effective treatment for tremor in patients with Multiple Sclerosis. Tremor is~     one of the most common symptoms in MS, but also one of the most difficult to treat. A very~     small previous study has indicated that Keppra may be effective in this role, but we need to~     reproduce these results in many more patients before we can reliably confirm this.~   "
238726|NCT00430586|"~     NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of~     proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening~     to full paralysis depending on the administered dose. Botulinum toxin type A is widely used~     for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201~     in the treatment of glabellar frown lines.~   "
238727|NCT00430573|"~     This study examines whether isolated doses of d-cycloserine enhance the efficacy of an~     exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance~     dependence.~   "
238728|NCT00430560|"~     This research investigates the benefits of productive activity and cognitive rehabilitation~     for patients with schizophrenia. Key questions are:~        1. does cognitive rehabilitation plus work activity produce better outcomes than work~          activity alone?~        2. Is cognitive rehabilitation more helpful for individuals with moderate or greater~          cognitive impairment than for individuals without such impairment?~        3. Does cognitive rehabilitation reduce the dropout rate and increase participation in work~          activity for cognitively impaired subjects?~        4. What features of cognitive rehabilitation are most important for clinical and~          rehabilitation outcomes?~   "
238729|NCT00430547|"~     The purpose of this study is to determine whether radioactive iodine, as compared to~     anti-thyroid medications, is a risk factor for the development or progression of~     thyroid-associated ophthalmopathy in patients with hyperthyroidism due to Graves' disease.~     The other aim of this study is to determine the incidence of the various ophthalmopathy~     subtypes and the utility of orbital antibodies in the diagnosis, classification and~     monitoring of patients with thyroid-associated ophthalmopathy.~   "
238730|NCT00430534|"~     To evaluate the safety, immune-response and efficacy of GSK Biologicals’ EBV vaccine in a~     population at risk of developing infectious mononucleosis. Each subject will receive three~     doses of vaccine or placebo during the study period.~   "
238731|NCT00430521|"~     The aim of the study is to assess the safety & immunogenicity of a pandemic influenza vaccine~     administered at 2 different time points. The Protocol Posting has been updated in order to~     comply with the FDA Amendment Act, Sep 2007.~   "
238734|NCT00430482|"~     This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus~     a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to~     emotional cues for drug use as part of a comprehensive, yet brief, treatment strategy. These~     treatments are delivered to opiate-dependent, often poly-substance dependent, individuals in~     a comprehensive methadone maintenance program who have failed to respond adequately to~     current treatments.~   "
238735|NCT00430469|"~     The safety and tolerability of hLF 1-11 given in multiple doses has to be established first~     in HSCT recipients who are at risk of developing, but have not yet developed, infectious~     complications due to invasive fungal or bacterial disease. These patients are different from~     healthy volunteers because they have received myeloablative treatment, which not only arrests~     haematopoiesis resulting in neutropenia but also induces mucosal barrier injury both of which~     predispose to infections, which typically occur during the week after transplant. It is~     therefore essential to know that hLF 1-11 is safe and well tolerated when given during~     neutropenia and mucosal barrier injury before infections ensue.~   "
238736|NCT00430456|"~     Individuals disabled by stroke are at risk of losing cardiovascular fitness and muscle due to~     disease. This worsens disability and can increase the risk of having another stroke or a~     heart attack. We would like to find out if and how different types of regular exercise~     (intense walking, long walking) can increase fitness, balance and improve walking function~     and activities of daily living in individuals who have suffered a stroke.~   "
238737|NCT00430443|"~     This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal~     annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment~     will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the~     MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Six dose levels~     of liposomal annamycin are planned: 130, 160, 190, 230, 280, and 310 mg/m2/day.The primary~     objectives of this study are 1) to evaluate the safety and identify the maximum tolerated~     dose (MTD) of liposomal annamycin when given in 3 consecutive daily doses, starting at 130~     mg/m2/day and ranging to as high as 310 mg/m2/day, or the MTD, whichever is lower, in~     children and young adults with refractory or relapsed acute lymphocytic leukemia (ALL) or~     acute myelogenous leukemia (AML), and 2) to evaluate the antileukemic activity of liposomal~     annamycin in children and young adults with refractory or relapsed ALL or AML. The secondary~     objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol.~   "
238738|NCT00430430|"~     Low and very low carbohydrate diets, such as the Atkins' Diet, have recently gained attention~     for their potential health benefits from weight loss and have gained some scientific support~     from a growing number of studies. Benefits have been noted in relation to raised good~     cholesterol, lower bad cholesterol and triglycerides. Other studies have shown an advantage~     in substituting vegetable fat for carbohydrate in insulin resistant individuals and in some~     instances in type 2 diabetes where improvements were seen in good cholesterol and blood~     sugars. At the same time, our research have been exploring diets containing less processed~     carbohydrates and other components which in combination (portfolio diet) have a similar~     cholesterol lowering effect to drug therapy.~      Therefore we wish to determine whether our cholesterol-lowering components (portfolio diet)~     should be incorporated into lower carbohydrate diets especially to preserve good~     cholesterol and lower bad cholesterol for decreasing the risk of heart disease.~   "
238739|NCT00430417|"~     The primary aim of the study is to measure bone formation in both lactating and non-lactating~     post-partum women and compare these to those in healthy non-pregnant controls. The secondary~     aim is to obtain measurements of Parathyroid Hormone-related Protein (PTHrP), markers of bone~     resorption, and calcium and vitamin D metabolism in these subjects. The investigators believe~     that lactating women will have an increase in bone resorption but no increase in bone~     formation when compared to non-lactating post-partum women and normal controls.~   "
238740|NCT00430404|"~     To evaluate the effectiveness of a community-based strategy of routine population mass~     screening for depression with follow-up feedback and management in a primary care~     non-psychiatric setting involving a structured, multifaceted, collaborative (primary care and~     hospital-based)shared care programme.~      Hypotheses:~      We hypothesize that a community-based early psychiatric interventional strategy (CEPIS) for~     depression in the elderly leads to increased recognition of depression by primary care~     physicians, more initiation of treatment for emotional problems, and improved outcomes for~     patients with depression, as measured by:~        1. increased rates of detection or recognition by a primary care physician of minor or~          major (clinical) depression.~        2. higher rates of management activities: counselling for psychological, family social~          problems, contact with community family services (human service agency), consultation~          and/or referral to a mental health specialist~        3. Reduced depressive symptom severity, improved level of daily functioning and quality of~          life among those with major clinical depression~        4. Better patient satisfaction with care~        5. Favourable clinician's and patients perception of their usefulness or acceptability~   "
238741|NCT00430391|"~     The purpose of this study is to examine a novel technique for improving the informed consent~     process for participation in research by the older psychiatric population.~   "
238742|NCT00430378|"~     The goal of this clinical research study is to learn if acupuncture is effective in~     preventing xerostomia (dry mouth) in cancer patients who receive radiation treatment to the~     head and neck area. Researchers also want to learn whether acupuncture lowers the severity of~     dry mouth that is experienced by these patients.~      Primary Objective:~      -Investigate if acupuncture is effective in preventing xerostomia among cancer patients at~     Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment to the~     head and neck area.~      Secondary Objectives:~        -  Determine whether acupuncture reduces the severity of xerostomia.~        -  Determine the feasibility of providing acupuncture treatment to patients at Cancer~          Hospital who are receiving radiation treatment for cancer of the head and/or neck area.~   "
238743|NCT00430365|"~     Maintenance treatment of myeloma.~   "
238744|NCT00430352|"~     This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy~     following a MabThera-containing induction regimen in first line or relapsed patients with~     follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface~     area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is~     1-2 years, and the target sample size is 500+ individuals.~   "
238745|NCT00430326|"~     This trial is being undertaken to investigate the efficacy and safety of Juvista in the~     improvement of scar appearance when administered to approximated wound margins following~     varicose vein surgery. The results from this trial will be used to select doses for~     investigation in future clinical trials with the compound.~   "
238746|NCT00430313|"~     Objectives:~      This protocol is part of a larger grant funded by the NCI to create an international research~     center to study Traditional Chinese Medicine (TCM). All of the patients enrolled in this~     study will be treated at the Cancer Hospital, Fudan University, investigator's sister~     institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be~     overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal~     Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25,~     2002). The research nurses have received training at MDACC and will receive regular oversight~     by MDACC personnel.~      The purpose of this randomized, placebo controlled study is to determine the effects of K1~     acustimulation at controlling chemotherapy induced nausea and vomiting (CINV).~        1. The primary aim of this study is to determine the effects of electro-stimulation of~          Yongquan (K1) acupoint on preventing nausea and vomiting induced by cisplatin or~          oxaliplatin.~        2. The secondary aim is to observe the effects of electro-stimulation (ES) of Yongquan (K1)~          acupoint on pain, insomnia, abdominal distention, dizziness, and general sense of~          well-being.~   "
238747|NCT00430300|"~     Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in~     patients with chronic obstructive pulmonary disease.~   "
238748|NCT00430287|"~     The purpose of this study is to determine how well the DDLS (Disc Damage Likelihood Scale)~     (which is a method used by the eye doctor to evaluate how healthy the optic nerve is)~     measures up to the standard glaucoma tests: OCT (Optical Coherence Tomography), the HRT~     (Heidelberg Retinal Tomography) and the HVF (Humphrey Visual Field).~   "
238749|NCT00430274|"~     Retinal structures are difficult to visualize because the retina is optically transparent. In~     glaucoma, the microglia in the retina becomes activated in eyes with glaucomatous damage. The~     microglia forms a dense meshwork which resembles gliosis-like alterations, which may increase~     light scattering. With appropriate technology, increased reflection and light scattering from~     the retina may be detected in eyes of glaucoma patients.~      In this study, we investigate whether clinically observable retinal gliosis-like alterations~     occur more often in patients with glaucoma than in non-glaucomatous controls, and whether~     gliosis-like alterations are associated with a vasospastic propensity.~   "
238750|NCT00430261|"~     This is an open-label study of a new oral drug for advanced stage (IIIB or IV) lung cancer.~     The cancer must be EITHER bronchoalveolar carcinoma (BAC) type, or if the patient is a~     never-smoker (less than 100 cigarettes lifetime) the cancer can be any type of~     adenocarcinoma.~   "
238751|NCT00430248|"~     The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily~     (QD), to allopurinol in subjects with hyperuricemia and gout.~   "
238752|NCT00430235|"~     Purpose:~      To determine the efficacy of BAY 43-9006 in combination with bicalutamide in patients with~     chemo-naïve hormone-refractory prostate cancer.~      Hypothesis:~      That there will be PSA response when BAY 43-9006 in combination with bicalutamide is given to~     patients with chemo-naïve hormone-refractory prostate cancer.~   "
238753|NCT00430209|"~     We hypothesize that glaucoma patients demonstrate an impaired retinal vascular response to~     the flicker stimulus, and that this disturbance is predictive of the progression of~     glaucomatous damage.~      The response of a major temporal superior and inferior retinal artery and vein to a 60~     seconds 12.5 Hz flicker light stimulation in 50 glaucoma patients, 50 ocular hypertensives~     and 50 controls (using the Retinal Vessel Analyzer) and to investigate how intraocular~     pressure relates to neurovascular coupling. In addition, 50 glaucoma patients and 50 ocular~     hypertension patients will be followed for 3 years for functional (visual field, automated~     perimetry with Octopus device) and morphological (retinal nerve fiber layer thickness,~     Optical Coherence Tomography Stratus ocular coherence tomography (OCT) device) glaucomatous~     damage progression, in order to test the predictive power of the retinal vascular flicker~     response for glaucoma progression.~   "
238754|NCT00430196|"~     In this study, we will compare BOTOX® versus Zanaflex ® for the treatment of muscle~     overactivity in the upper limb following stroke or brain traums. This is a critical step in~     the development of local intramuscular treatment for patients with muscle overactivity~     following an acute brain lesions, as opposed to the more classic oral treatments.~      This study will be a multicenter, randomized, prospective, parallel, double blind study that~     enrolls subjects at twelve sites (including Mt. Sinai) throughout the United States and~     Europe. The purpose of this study is to evaluate the safety and efficacy of BOTOX® compared~     to Zanaflex® in reducing upper limb muscle tone in post-stroke subjects, as well as~     evaluating changes in muscle tone-related disability and drug-therapy tolerance. This will be~     an 18 week study. Subjects are eligible if they have been medically stable with upper limb~     spasticity 6 months after their first stroke. Subjects will be randomized to one of three~     treatment groups: Treatment Group I - intramuscular BOTOX® plus oral placebo, Treatment Group~     II - intramuscular placebo plus oral Zanaflex®, Treatment Group III - intramuscular placebo~     plus oral placebo. The dose of BOTOX® will be at the discretion of the investigator with a~     maximum of 500 U per subject. The dose of the Zanaflex® will be 4mg/day to a maximum of~     36mg/day. The study anticipates that 150 subjects will be enrolled to provide sufficient~     information to answer the primary objective of safety and efficacy of the study.~   "
238755|NCT00430183|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as~     goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel~     and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount~     of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and~     leuprolide or goserelin before surgery is more effective than surgery alone in treating~     patients with prostate cancer.~      PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to~     see how well they work when given before surgery compared with surgery alone in treating~     patients with high-risk localized prostate cancer.~   "
238757|NCT00430157|"~     This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect~     versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber.~     GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in~     development by GSK for the treatment of allergic rhinitis, asthma and COPD.~      Subjects will be selected on the basis that they display a defined moderate response to the~     pre-determined dose used.~      This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients~     with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.~      12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal~     examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge~     assessments will also be performed at various time points throughout the study.~   "
238758|NCT00430144|"~     -list item one, The purpose of this study is to evaluate the overall response rate of~     belotecan (CKD-602) in recurrent or progressive carcinoma of uterine cervix~   "
238759|NCT00430131|"~     This project (CO-OP II) is the second in a series of three studies to validate a new~     treatment approach for children with cerebral palsy (CP). The initial study was comprised of~     a series of four single case studies with children with CP. It evaluated the potential of the~     Cognitive Orientation to Occupational Performance (CO-OP) approach to be used with children~     with CP and tested the procedures for CO-OP II. The overall objective of the full series of~     studies is to determine whether better functional outcomes are achieved for children with CP~     with CO-OP intervention than with contemporary occupational therapy treatment.~      The primary objective of CO-OP II is to establish the feasibility of conducting a full scale~     randomize control trial (RCT) to discover if there are differences in functional outcomes~     (i.e., improvement in task performance, self efficacy) between a group of children with CP~     receiving CO-OP therapy and a group receiving a contemporary treatment approach (CTA). In~     order to meet this objective, a pilot RCT will be conducted to answer the specific research~     questions outlined below:~        1. Do children wiht CP acquire the skills they set as goals in each of the two treatment~          groups?~        2. Do the acquired skills generalize and transfer?~        3. Are the skills maintained at 4 months post intervention?~        4. Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy~          than the CTA?~        5. Does amount of parent involvement have any effect on skill acquisition or self efficacy?~      Completion of this pilot RCT will provide the necessary data to conduct a full study to test~     the following hypothesis:~      - Children with CP who receive CO-OP treatment will be more successful than children~     receiving CTA in improving their performance on child-chosen skills and they self efficacy.~   "
238760|NCT00430118|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating young patients with acute~     lymphoblastic leukemia.~      PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens~     to compare how well they work in treating young patients with acute lymphoblastic leukemia.~   "
238761|NCT00430105|"~     A comparison of intermittent pulsed cyclophosphamide to daily oral cyclophosphamide for the~     treatment of ANCA-associated systemic vasculitides with kidney involvement.~      Performed by the European Vasculitis Study group.~   "
238762|NCT00430092|"~     The purpose of this phase III study is to determine the efficacy of difluprednate in the~     treatment of inflammation following ocular surgery.~   "
238763|NCT00430079|"~     This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients~     undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma.~     Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help~     in planning cancer treatment~   "
238764|NCT00430066|"~     The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single~     agent, in inducing a haematological response in Polycythemia Vera.~      The patients will be asked to have additional bone marrow and blood samples collected: these~     samples will be used to evaluate how the disease is responding to the drug.~   "
238765|NCT00430053|"~     RATIONALE: Gathering information about patients with cutaneous T-cell lymphoma over time may~     help doctors learn more about the disease.~      PURPOSE: This natural history study is collecting disease-related health information over~     time from patients with cutaneous T-cell lymphoma.~   "
238766|NCT00430040|"~     To determine whether addition of Carvedilol CR to diabetic patients with hypertension who are~     receiving the ACEi,Lisinopril,will provide added benefits to blood vessels when compared to~     treatment with Lisinopril alone.It is believed that carvedilol provides added benefits by~     suppressing free radicals(charged substances that cause damage to the body ) and~     inflammation.~   "
238767|NCT00430027|"~     The primary objective of this pilot study is to determine whether neoadjuvant~     capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical~     resection [and then followed by post operative adjuvant capecitabine, oxaliplatin and~     cetuximab] is feasible and tolerable.~   "
238768|NCT00430014|"~     Primary Objectives:~      The primary objectives of this study are to identify the maximum tolerated dose (MTD) and to~     evaluate the safety of atiprimod when given in doses starting at 60 mg/day and ranging to 360~     mg/day, or the MTD, whichever is lower, in patients with advanced cancer.~      Secondary Objectives:~      The secondary objectives of this study are to measure the pharmacokinetics of atiprimod and~     to evaluate the efficacy of atiprimod treatment in patients with advanced cancer, and to~     compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the~     intent of switching to capsules for the dose escalation if the capsules pose no safety~     issues.~   "
238769|NCT00430001|"~     In an open-label randomised phase III-trial patients with metastatic HER2-positive breast~     cancer naive to chemotherapy with normal organ function and WHO performance status < 3 are~     randomised to receive either docetaxel 100 mg/m2 i.v. plus trastuzumab 6 mg/kg (8 mg/kg~     loading dose) q 3 weeks or vinorelbine 30 or 35 mg/m2 days 1+8 plus trastuzumab 6 mg/kg (8~     mg/kg loading dose) q 3 weeks. Primary endpoint is time to progression. Secondary endpoints~     include overall survival, time to treatment failure, response rate, duration of response and~     toxicity. The study hypothesis is that docetaxel is more efficient than vinorelbine but also~     more toxic.~   "
238770|NCT00429988|"~     RATIONALE: Collecting samples of fluid using ductal lavage and nipple aspiration from~     participants at high risk for breast cancer to study in the laboratory may help doctors learn~     more about changes that may occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high risk~     for breast cancer.~   "
238771|NCT00429975|"~     The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine~     production in patients with pneumococcal pneumonia.~   "
238772|NCT00429962|"~     This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab~     used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab~     monotherapy for the treatment of subfoveal CNV secondary to AMD~   "
238773|NCT00429949|"~     To evaluate the response rate (Complete Response [CR] and Partial Response [PR]) to dasatinib~     in patients with relapsed, refractory or plateau phase multiple myeloma whose serum~     paraprotein levels are >0.5g/dL or urine paraprotein levels are >1.0g/24 hours.~   "
238774|NCT00429936|"~     The purpose of this phase II study is to determine the efficacy of fenretinide in the~     treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular~     degeneration (AMD).~   "
238775|NCT00429923|"~     The purpose of this phase III study is to determine the efficacy of difluprednate in the~     treatment of inflammation following ocular surgery.~   "
238776|NCT00429910|"~     RATIONALE: Gathering information about patients with chronic myelogenous leukemia may help~     doctors learn more about the disease and find better methods of treatment and on-going care.~      PURPOSE: This natural history study is collecting health information and disease-related~     information over time from patients with newly diagnosed chronic myelogenous leukemia.~   "
238777|NCT00429897|"~     The principle objective of the study is to determine whether low-renin (i.e. salt sensitive)~     hypertension at a young age is caused by the kidneys hanging onto too much salt as a result~     of an over active salt pump in the kidney.~      The kidneys have four different salt pumps, and each is blocked by a different type of~     diuretic (salt losing tablet)If one out of the four is overactive, we would expect patients~     to respond much better to one diuretic than to the alternatives - rather than responding~     equally well to all available types of diuretic.~   "
238778|NCT00429884|"~     The purpose of this study is to investigate if breathing disorders are related to atrial~     fibrillation and if it is possible to predict recurrence of atrial fibrillation after~     DC-conversion by changes in heart rate variability and 24 hour ECG.~   "
238779|NCT00429871|"~     The combination of docetaxel+epirubicin is highly effective and well tolerated as first line~     treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in~     women with MBC pretreated with taxane and anthracycline. Docetaxel increases the~     intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine.~     The combination of docetaxel plus capecitabine is highly active and superior to docetaxel~     monotherapy in women with MBC pretreated with an anthracycline~   "
238780|NCT00429858|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict a patient's response to~     treatment and help plan the best treatment.~      PURPOSE: This phase II trial is studying gene expression in predicting treatment response in~     patients receiving gemcitabine and S-1 for locally advanced unresectable or metastatic~     pancreatic cancer.~   "
238781|NCT00429845|"~     Highly active antiretroviral therapy (HAART) in HIV-positive patients is associated with the~     development of dyslipidemia, a risk factor for cardiovascular events. The objective of this~     study was to evaluate the effect of dietary intervention in individuals who start HAART.~   "
238782|NCT00429832|"~     This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron~     and promethazine, in the Emergency Department.~   "
238783|NCT00429819|"~     We hypothesize that glaucoma patients demonstrate an impaired retinal vascular response to~     the flicker stimulus, and that this disturbance is predictive of the progression of~     glaucomatous damage.~      The response of a major temporal superior and inferior retinal artery and vein to a 60~     seconds 12.5 Hz flicker light stimulation in 50 glaucoma patients, 50 ocular hypertensives~     and 50 controls (using the Retinal Vessel Analyzer) and to investigate how intraocular~     pressure relates to neurovascular coupling. In addition, 50 glaucoma patients and 50 ocular~     hypertension patients will be followed for 3 years for functional (visual field, automated~     perimetry with Octopus device) and morphological (retinal nerve fiber layer thickness,~     Optical Coherence Tomography Stratus (OCT) device) glaucomatous damage progression, in order~     to test the predictive power of the retinal vascular flicker response for glaucoma~     progression.~   "
238784|NCT00429806|"~     The purpose of the study is to evaluate the systemic bioavailability of DHEA and its~     metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA~     concentration.~   "
238785|NCT00429793|"~     This phase II trial is studying the side effects and how well temsirolimus works in treating~     patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or~     primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
238798|NCT00429611|"~     This inhospital study aims to compare the efficacy of high-versus low-energy biphasic shocks~     in order to determine the optimal level for defibrillation. Time is the essence when~     attending to a VF patient. Hence, it is important to determine the optimal amount of~     defibrillation energy that should be delivered at first shock, thereby increasing the~     patient's chances of survival. In addition, this study provides an opportunity to evaluate~     the impact on myocardial integrity/function of different levels of defibrillation energy in~     an inhospital clinical environment.~   "
238799|NCT00429585|"~     This study looks at two types of surgical treatments and hopes to answer the question: which~     is the best way to surgically treat a proximal tibia fracture? Both procedures being studied~     are standard of care (used routinely) and use FDA approved devices. All medical and surgical~     treatment will be the same for participants as non-participants.~   "
239560|NCT00419445|"~     This study will be a randomized, double-blind, placebo-controlled crossover study to assess~     the effects of GTS21 (25 mg three times a day (tid), 75 mg tid, 150 mg tid) compared to~     placebo in non-smoking adults aged 18-55 with a diagnosis of ADHD, any subtype.~   "
238786|NCT00429780|"~     Development of a safe and effective vaccine against leishmaniasis started more than 10 years~     ago under WHO/TDR supervision. An autoclaved L. major vaccine (ALM) mixed with BCG has been~     tested in human in Iran, Pakistan and Sudan. Long term follow up of the vaccinees showed no~     untoward reactions except the skin reaction at the site of injection. The efficacy results of~     ALM was not satisfactory. In order to enhance immunogenicity of the vaccine, ALM was adsorbed~     to alum (Aluminum hydroxide). Alum-ALM plus adjuvant showed to induce protection in Rhesus~     monkeys against cutaneous leishmaniasis and in Languor monkeys against visceral~     leishmaniasis. Two trials of a single injection of different doses of Alum-ALM mixed with~     1/10th of normal dose of BCG was carried out in healthy volunteers from a non endemic area of~     Sudan. The safety/immunogenicity parameters of the volunteers were closely monitored and the~     results showed that side effects were minimal and confined to the site of injection in the~     form of mild local pain, induration and ulceration, all associated with BCG vaccination. The~     immunogenicity results showed the strongest immune response seen in any Leishmania vaccine~     trials so far. It seems that this new formulation is an appropriate candidate for further~     development. Inoculation with live virulent Leishmania to produce a lesion for the purpose of~     preventing natural infection is known as leishmanization. The induced lesion heals and the~     person is usually protected against further infections. This method of prevention was~     practiced for centuries in the region. In this study volunteers with response to leishmanin~     will be injected twice (30 days apart) with Alum-ALM 200 ug + 1/10 of BCG (n = 50) or diluent~     alone (n = 50) as control. All volunteers will be leishmanized on day 60 post vaccination. In~     this trial, volunteers are protected either by vaccine or by leishmanization. The~     leishmanized volunteers will be visited by weekly and the development and healing process of~     the lesion will be monitored until complete healing of every volunteer. The immune responses~     of the volunteers will be evaluated. Vaccine efficacy is defined by the percent reduction in~     the number of volunteers developing a lesion following leishmanization as compared to~     controls on days 240.~   "
238787|NCT00429767|"~     The purpose of this study is to determine whether maintenance on different oral doses of~     sustained release d-amphetamine (SR-AMP) combined with constant-dose sublingual buprenorphine~     (BUP) is safe and well tolerated and decreases self-administration of cocaine alone or~     combined with hydromorphone (HYD). Secondary aims are to determine whether SR-AMP attenuates~     the subjective and physiological effects of cocaine during drug sampling periods prior to~     choice opportunities.~   "
238788|NCT00429754|"~     The purpose of the study is to investigate whether there is an interaction occurs between~     etoposide and aprepitant in patients with testis carcinoma treated with the standard BEP~     regimen.~      Also to determine how long treatment with aprepitant is necessary in BEP regimen for 5~     consecutive days.~   "
238789|NCT00429728|"~     This study will investigate the effect of smoking on the metabolism of a single oral dose of~     GW876008.~   "
238790|NCT00429715|"~     Development of a safe and effective vaccine against leishmaniasis started more than 10 years~     ago under WHO/TDR supervision. An autoclaved L. major vaccine (ALM) mixed with BCG has been~     tested in human in Iran, Pakistan and Sudan. Long term follow up of the vaccinees showed no~     untoward reactions except the skin reaction at the site of injection. The efficacy results of~     ALM was not satisfactory. In order to enhance immunogenicity of the vaccine, ALM was adsorbed~     to alum (Aluminum hydroxide). Alum-ALM plus adjuvant showed to induce protection in Rhesus~     monkeys against cutaneous leishmaniasis and in Languor monkeys against visceral~     leishmaniasis. Two trials of a single injection of different doses of Alum-ALM mixed with~     1/10th of normal dose of BCG was carried out in healthy volunteers from a non endemic area of~     Sudan. The safety/immunogenicity parameters of the volunteers were closely monitored and the~     results showed that side effects were minimal and confined to the site of injection in the~     form of mild local pain, induration and ulceration, all associated with BCG vaccination. The~     immunogenicity results showed the strongest immune response seen in any Leishmania vaccine~     trials so far. It seems that this new formulation is an appropriate candidate for further~     development. Inoculation with live virulent Leishmania to produce a lesion for the purpose of~     preventing natural infection is known as leishmanization. The induced lesion heals and the~     person is usually protected against further infections. This method of prevention was~     practiced for centuries in the region. In this study volunteers with no response to~     leishmanin will be injected twice (30 days apart) with Alum-ALM 200 ug + 1/10 of BCG (n = 50)~     or BCG (n = 50) or BCG diluent alone (n = 50) as control. All volunteers will be leishmanized~     on day 60 post vaccination. In this trial, volunteers are protected either by vaccine or by~     leishmanization. The leishmanized volunteers will be visited by weekly and the development~     and healing process of the lesion will be monitored until complete healing of every~     volunteer. The immune responses of the volunteers will be evaluated. Vaccine efficacy is~     defined by the percent reduction in the number of volunteers developing a lesion following~     leishmanization as compared to controls on days 240.~   "
238791|NCT00429702|"~     RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea~     and vomiting in patients treated with chemotherapy. It is not yet known whether~     diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in~     treating nausea and vomiting caused by chemotherapy.~      PURPOSE: This randomized phase II trial is studying diphenhydramine, lorazepam, and~     dexamethasone to see how well they work compared with standard therapy in treating nausea and~     vomiting caused by chemotherapy in young patients with newly diagnosed cancer.~   "
238792|NCT00429689|"~     Subjects will be 1000 men meeting the following inclusion criteria: 1) male, age 18-65 years;~     2) meeting DSM-IV criteria for major depressive disorder within the past one year, with a~     HAM-D score >12.~      Subjects will be excluded if they exhibit 1) a substance abuse or dependence disorder within~     the past year; 2) current psychotic symptoms; or 3) a history of bipolar disorder.~      Procedure~      After informed consent, eligible patients will have blood drawn for serum hormone levels;~     cortisol, DHEA-S and testosterone or they will provide a salivary sample for measurement of~     hormone levels.~      We will also test hormone level form 1000 healthy males (from blood or saliva) at the same~     age for comparison.~   "
238793|NCT00429676|"~     The goal of this study is to determine whether haloperidol reduces the time on the breathing~     machine in critically ill patients with delirium.~   "
238794|NCT00429663|"~     This study looks at two (2) types of surgical treatments and hopes to answer the question,~     which is the best way to surgically treat a distal femur fracture? Both procedures being~     studied are standard of care (used routinely) and use FDA approved devices. All medical and~     surgical treatment will be the same for participants as non-participants.~   "
238795|NCT00429650|"~     The major challenge in obesity treatment is not producing weight loss but in preventing that~     weight from being regained. There are many different methods to lose weight, but there are no~     recommendations for how you can best achieve long-term weight loss maintenance. Despite the~     method used to reduce one's body weight, very few of these individuals are able to keep their~     weight off permanently. This project aims to identify how much activity is necessary to~     prevent weight regain after weight loss.~   "
238796|NCT00429637|"~     Given the possible prognostic relationship between exhaled breath condensate pH and clinical~     symptoms, it is quite plausible that exhaled breath condensate pH can prove useful in the~     intensive care unit. For example, if exhaled breath condensate pH falls prior to the onset of~     clinical symptoms, it is likely that it can be useful as an early marker, heralding the onset~     of various inflammatory lung diseases. Specifically, exhaled breath condensate pH could be~     used as a safe, non-invasive screening tool for Ventilator Associated Pneumonia. Similarly,~     just as changes in exhaled breath condensate pH might predict the onset of disease, exhaled~     breath condensate pH changes might also mark the progression or resolution of disease (e.g.~     alerting clinicians to possible readiness for extubation). Although such notions are~     hypothetical, they are beginning to be supported by anecdotal evidence.~   "
238800|NCT00429572|"~     Primary Objectives:~        1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC)~          transplantation in patients with recurrent or metastatic breast cancer.~        2. To determine the success rate (complete remission without severe toxicity or death) at~          100 days after the transplant and long-term progression free survival (PFS) rate.~        3. To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.~   "
238801|NCT00429559|"~     Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This~     trial will determine the maximum tolerated dose and the efficacy of this combination~     administered weekly in patients with platinum -resistant ovarian cancer.~   "
238802|NCT00429546|"~     This study will develop and evaluate the effectiveness of an intervention designed to assist~     HIV-infected mothers of young children in determining whether and how to appropriately~     disclose their HIV serostatus to their children.~   "
238803|NCT00429533|"~     The purpose of this 12-month study was to determine the efficacy of dapsone as a~     glucocorticoid-sparing agent in maintenance phase pemphigus vulgaris.~   "
238804|NCT00429520|"~     Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are~     followed-up for up to 36 weeks.~   "
238805|NCT00429507|"~     Primary objectives:~      - To determine the time to progression in subjects with breast cancer metastatic to bone only~     treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).~      Secondary objectives:~        -  To determine the overall survival at one year.~        -  To determine the efficacy of 153Sm-EDTMP at 6 months.~        -  To assess pain in subjects treated with 153Sm-EDTMP.~        -  To determine the safety of 153Sm-EDTMP.~   "
238806|NCT00429494|"~     Primary Objectives:~        -  To determine the effectiveness of the 3-month depot leuprolide in inducing and~          maintaining secondary amenorrhea in patients undergo hematopoietic stem cell~          transplantation.~        -  To determine the incidence of regained ovarian function manifested as spontaneous~          restoration of menstruation and normalization of hormonal level in patients after~          transplantation and discontinuation of long-acting leuprolide.~   "
238807|NCT00429481|"~     To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different~     concentrations) in healthy infants aged approximately 3 months previously uninfected with~     human rotavirus.~   "
238808|NCT00429468|"~     The purpose of this research study is to determine if varying strengths of ethanol affect the~     drug level and safety profile of Vicodin® CR.~   "
238809|NCT00429455|"~     Primary Objective:~      - To understand the importance of receiving information on fertility- and menopause-related~     treatment effects for female patients undergoing hematopoietic stem cell transplantation.~   "
238810|NCT00429442|"~     A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on~     Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated~     with Copaxone for at least 3 months~   "
238811|NCT00429429|"~     Currently, when a food allergy is diagnosed, the standard of care is strict avoidance of~     the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions~     do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an~     inadvertent ingestion is great. It is estimated that over 50% of individuals who are allergic~     to peanuts will have an accidental reaction to peanuts over a 2-year period. The purpose of~     this study is to determine if peanut sublingual immunotherapy (SLIT) reduces the number~     and/or symptoms of accidental peanut ingestion in peanut allergic subjects. We would~     anticipate that the subjects on the peanut SLIT protocol would experience few adverse effects~     with accidental peanut ingestion over the course of the two years of SLIT. The primary~     endpoint to evaluate the effectiveness of SLIT will be a negative DBPCFC to peanuts (8 grams)~     at the completion of the two years of the study.~   "
238812|NCT00429416|"~     The purpose of this research study is to determine if an experimental agent, LLME can~     decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following blood~     (hematopoietic) stem cell transplantation~   "
238813|NCT00429403|"~     Primary Objective:~        -  To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian~          function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for~          primary invasive breast cancer by documenting persistence or resumption of regular~          menses.~      Secondary Objectives:~        -  To determine the incidence of pregnancy and the effect for participants' quality of life~          (QOL) after chemotherapy.~        -  To determine the overall survival and disease-free survival times of study participants.~   "
238814|NCT00429390|"~     this study was conducted to assess the insulin resistance indices in the subjects undergoing~     Ramadan fasting (diet which consisted of two meals at 12 hours intervals)for a thirty days~     period.~   "
238815|NCT00429377|"~     This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study~     in steroid refractory Lupus Nephritis patients.~   "
238816|NCT00429364|"~     Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this~     condition die because of the associated heart and blood vessel abnormalities. This study will~     compare the effectiveness of two medications, losartan and atenolol, at slowing aortic root~     enlargement in individuals with Marfan syndrome.~   "
238817|NCT00429351|"~     This research may explain whether a shortage of three special compounds called aromatic amino~     acids is responsible for the severe illness and high death rate of children with the~     kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in~     the treatment diet will speed up recovery from this condition. We propose that decreased~     availability of the aromatic amino acids may be the reason why children with kwashiorkor are~     sicker and more difficult to treat.~   "
238818|NCT00429338|"~     The objective of this study is to evaluate the feasibility of 3T magnetic resonance~     spectroscopic imaging (MRSI) of the prostate in improving the spectral resolution, using a~     perfluorocarbon compound (PFC)-filled endorectal coil.~      Specific Aim 1: To compare the spectral quality, measured in Hz (linewidth), of 3T MRSI~     performed with an air-filled endorectal coil (AIR-MRSI) and a PFC-filled endorectal coil~     (PFC-MRSI).~      Specific Aim 2: To compare the quality of spectra of PFC-MRSI by grading the overall quality~     of MRSI data of each patient subjectively as being excellent, good, fair, poor, and~     non-diagnostic, based on the status of subjective spectral resolution of Cho, Cr and Po~     peaks, signal to noise ratio (SNR), baseline distortion, and fat contamination.~   "
238819|NCT00429325|"~     Every year more than 4 billion cases of diarrhea occur worldwide culminating in about 2.5~     million deaths, almost all in the developing nations. Reliable diagnosis of patients with~     acute infectious diarrhea which could be appropriately managed with antibiotics at~     presentation still remains a formidable challenge to the clinicians. To address this issue of~     predicting microbiological infectious etiology for diagnosing acute infectious diarrhea, we~     would evaluate stools from all patients with acute diarrhea with culture, Guaiac based fecal~     occult blood test (FOBT), Calprotectin and lactoferrin assays simultaneously. This would be~     the first study evaluating fecal calprotectin as a diagnostic marker in acute diarrhea~   "
238820|NCT00429312|"~     The purpose of this research study is to find out whether JX-594 (Pexa-Vec) is safe and~     effective for treating surgically unresectable malignant melanoma.~   "
238821|NCT00429299|"~     Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with~     chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.~   "
238822|NCT00429286|"~     Breast cancer patients experience functional limitations related to the cancer and treatment~     side effects. Early functional limitations affect short- and long-term quality of life, and~     may lead to long-term complications. Patients living in rural areas are at particular risk~     because they do not have easy access to services. Therefore, early intervention is indicated~     to have an impact on the overall public health. Problem solving training (PST) is a~     standardized manual driven intervention that may be ideally suited to assist breast cancer~     patients to preserve their valued activities and to comply with recommended symptom~     management regimens (e.g., physical therapy, aerobic exercise and relaxation/guided imagery)~     that improve function. Telephone-based PST provided from a centralized location (such as the~     comprehensive cancer center) may improve access and outcomes in a cost-effective manner. We~     propose to conduct a feasibility study of a PST intervention with 30 rural breast cancer~     patients undergoing adjuvant treatment randomly assigned to PST or to usual care. The~     intervention group will receive weekly phone-based PST sessions for six consecutive weeks.~     The specific aims of this R03 small grant application are to:1) Test the feasibility of~     enrolling and retaining newly diagnosed breast cancer patients in a clinical trial to assess~     telephone-based PST. 2) Collect preliminary data on outcome measures of function to determine~     effect size estimates that will inform power analyses for a full scale randomized controlled~     study. Primary outcome measures will be acceptance rates for enrollment in the study,~     retention rates across both intervention arms, and satisfaction levels with the PST~     intervention. Assessments will be conducted at baseline, and at six weeks (end of PST~     intervention) and 3 months following baseline. The long-term goal of this line of~     investigation is to develop practical, widely applicable rehabilitation models of care to~     preserve function and decrease distress in cancer patients undergoing treatment.~   "
238823|NCT00429273|"~     This study will evaluate the effectiveness of a single drug versus a combination of drugs in~     treating attention deficit hyperactivity disorder in children.~   "
238824|NCT00429260|"~     The primary objective is to evaluate the safety and tolerability of abrupt discontinuation of~     saredutant over 1 week in outpatients with depression who completed 8 weeks of treatment with~     saredutant 100 mg once daily.~      The secondary objective is to evaluate the safety and tolerability of 8 weeks of open-label~     treatment with saredutant 100 mg once daily in outpatients with depression.~   "
238825|NCT00429247|"~     Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood~     [disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively] of otherwise~     metastases-free patients with early breast cancer. Several studies have shown that the~     presence of these cells is an independent factor associated with an increased incidence of~     early disease relapse and disease-related death. In almost 50% of the patients, adjuvant~     chemotherapy cannot eliminate these occult tumor cells and this is also associated with a~     higher probability of early relapse and death. In 60-70% of the patients, DTCs and/or CTCs~     express the HER2/c-neu molecule and one or two administrations of their monoclonal antibody~     trastuzumab (HERCEPTIN) could eliminate these cells for a period ranging from 3-12 months.~   "
238826|NCT00429234|"~     The goal of this clinical research study is to find the highest tolerable dose of dasatinib~     in combination with gemcitabine that can be given to patients with advanced solid tumors. The~     safety of this combination of study drugs will also be studied.~      Researchers also want to study the pharmacodynamics (PDs) of this study drug combination. PD~     testing is used to learn what effect the drugs have on your tumors.~   "
238827|NCT00429221|"~     This three-phase study will develop and test a provider-administered intervention to improve~     medication adherence and promote sustained medication use among children with ADHD and their~     caregivers.~   "
238828|NCT00429208|"~     This research project addresses the hypothesis that a neurocognitive profile characterized by~     impairment of response inhibition and sustained attention may be a risk factor for smoking~     initiation and nicotine dependence among young women. Nicotine has short- term, facilitating~     effects on attention and response inhibition. Therefore, individuals who are impaired on~     cognitive functions such as these and initiate cigarette smoking may be more likely to~     maintain the habit and develop nicotine dependence. The research protocol specifically tests~     whether administration of nicotine to non-abstinent, regular cigarette smokers improves~     cognitive function in those domains where the participants had previously been shown to~     manifest performance deficits~   "
238829|NCT00429195|"~     The LIPGENE Human Dietary Intervention Study, multi-centre, trans -European, single-blinded,~     randomised, controlled trial with two principal aims. Firstly to determine the relative~     efficacy of reducing dietary SFA consumption, by altering quality of dietary fat and reducing~     the quantity of dietary fat, on metabolic and molecular risk factors of the metabolic~     syndrome. Secondly to determine if common genetic polymorphisms affect an individual's~     responsiveness to dietary therapy.~   "
238830|NCT00429182|"~     The goal of this clinical research study is to learn the relationship of high-dose~     chemotherapy (HDCT) and circulating tumor cells (CTCs) in controlling metastatic breast~     cancer. The study also will investigate the role of CTCs in breast cancer.~   "
238831|NCT00429169|"~     The primary study comparing effectiveness for suicidal ideation and/or behavior of two~     antidepressant medications in depressed patients who have attempted suicide or are currently~     experiencing suicidal thoughts has been completed.~      A secondary study component using functional magnetic resonance imaging (fMRI) to investigate~     different medication effects on reward processing in the same sample is ongoing.~   "
238875|NCT00428584|"~     To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with~     relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site~     pain scores from pre-injection to 30 minutes post therapy administration.~   "
239618|NCT00418691|"~     Primary Objective:~        -  To assess the efficacy of immediate release methylphenidate, sustained release~          methylphenidate, and the novel vigilance enhancing drug modafinil for the improvement of~          cognitive functioning in patients with brain tumors.~   "
238832|NCT00429156|"~     The investigators hypothesize that continuation of non-invasive ventilation (NIV) at home~     after an episode of acute hypercapnic respiratory failure (AHRF) treated by NIV in COPD~     patients would reduce the likelihood of death and recurrent AHRF requiring NIV or intubation.~     The investigators designed this study in a way that recruited COPD patients would be started~     on home NIV or sham treatment after an episode of AHRF requiring acute NIV. The patients are~     acclimatised to NIV application after a few days of acute use. The investigators chose~     occurrence of life-threatening event (recurrent AHRF and death) as the primary endpoint.~   "
238833|NCT00429143|"~     The purpose of this study is to develop a way of treating patients who do not have a~     completely matched family donor or a readily available unrelated donor with bone marrow~     transplant by using a partially-matched family donor. Patients receiving this type of~     transplant will receive chemotherapy and/or radiation to treat their disease. They will also~     receive their donor's cells in 2 parts. During the first part, the donor's lymphocytes will~     be exposed to one of the chemotherapy agents to help the patient become tolerant to the~     lymphocytes. In the second part of the transplant, the patient will receive their donor's~     stem cells to help recover their peripheral blood counts and establish long-term engraftment.~     The hypothesis of this study is that in partially-matched allogeneic transplant, there is a~     defined number of donor T-cells that can be treated and given to the recipient to avoid~     post-transplant infection without causing severe graft-versus-host disease.~   "
238834|NCT00429117|"~     Primary Objective:~      -To assess correlations between spiritual and religious beliefs and physician burnout using~     the Work Related Stress Inventory.~      Secondary Objectives:~        -  To assess relationships between a physician's spiritual/religious beliefs and age, race,~          sex, marital status, and nationality.~        -  To explore differences in survey responses among oncologists from different countries:~          Duke University Religion Index (DUREL), Hoge (Intrinsic religiosity scale), Templer's~          Death Anxiety Scale, Locus of Control Scale, Work Related Strain Inventory, and~          non-validated case scenarios.~        -  To correlate survey responses to management of specific patient case situations.~   "
238835|NCT00429104|"~     Primary Objectives:~        1. To determine the patient's tumor response rate that this protocol will produce.~        2. To determine the 1 year progression-free survival that this protocol will produce.~      Secondary Objective:~      1. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism~     of overcoming Herceptin-resistance by use of Granulocyte-Macrophage Colony Stimulating Factor~     (GM-CSF).~   "
238836|NCT00429091|"~     A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with~     Attention-Deficit/Hyperactivity Disorder (ADHD)~   "
238837|NCT00429078|"~     This study proposes to determine the safety and tolerability of 2nd generation designer T~     cells in patients with gastric cancer.Designer T cells are prepared by removing white blood~     cells from the participant, and then modifying these cells so that they recognize tumor~     antigen(CEA). These modified cells are then re infused back into the participant so that they~     can attack and kill tumor cells.Eligibility for this study is diagnosis of carcinoma of the~     stomach with failure to respond to standard curative therapy. Tumors must express CEA as~     demonstrated by elevated serum CEA >10ng/ml and be measurable radiologically or by physical~     exam.~   "
238838|NCT00429065|"~     The purpose of this study is to determine whether a specific subtype of lymphoma responds~     optimally to treatment with rituximab and chemotherapy.~   "
238839|NCT00429052|"~     The main objectives of this study are define frequency of plaque shift phenomenon and impact~     on flow dynamics in the side branch as assessed by intravascular ultrasound, and evaluate~     acute and late side branch ostial vessel reaction to balloon angioplasty and drug-eluting~     stents.~   "
238840|NCT00429039|"~     The purpose of this study is to determine if pre-treating donor lymphocytes with an~     investigational drug known as L-leucyl-L-leucine methyl ester (LLME, prior to donor~     lymphocyte infusion (DLI) will improve the recovery of the immune system following stem cell~     transplant.~   "
238841|NCT00429026|"~     Primary Objectives:~        1. To compare the overall survival of metastatic renal cell carcinoma (RCC) patients~          undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell~          transplantation (NST) using fludarabine-melphalan (FM) versus~          fludarabine-cyclophosphamide (FC) conditioning regimen.~        2. To assess both cytotoxic T lymphocyte reactivity and antibodies activity against~          potential tumor antigenic peptides involved in graft-versus-RCC effect.~      Secondary Objectives:~        1. To study the patient characteristics of metastatic RCC patients who undergo NST and~          those who do not undergo NST.~        2. To compare the incidence of Day-100 treatment-related mortality in FM group and FC~          group.~   "
238842|NCT00429013|"~     Will the use of sensory substitution by lingual electric stimulation improve in a suitable~     way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin~     interface in order to prevent the formation of pressure ulcer? We will try to demonstrate~     that paraplegic subject move in an appropriate matter, in term of pressure, after a movement~     way advised by periodical electric stimuli on the tongue.~   "
238843|NCT00429000|"~     Low body temperature (hypothermia (HT)) at birth contributes to infant mortality in~     low-income countries. A study from Guinéa-Bissau indicates that HT results in an increased~     mortality rate, which persist at least two months after birth. Therefore interventions that~     reduce the prevalence of HT might have a significant effect on infant mortality. The purpose~     of the proposed study is to identify risk factors for HT in an in-hospital setting in~     Guinea-Bissau and to investigate whether continuous temperature-monitoring enabling early~     detection of HT and treatment can prevent HT <34,5°C.~   "
238935|NCT00427765|"~     Primary Objectives:~        1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan~          at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily~          area under the plasma concentration versus time curve (AUC) of approximately 5,000~          mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in~          adult patients receiving autologous or allogeneic transplantation for lymphoid~          malignancies or myeloma.~        2. To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this~          regimen.~        3. To determine the disease-free and overall survival of patients receiving this~          preparative regimen.~        4. To determine the treatment-related morbidity and mortality of this combination of drugs.~   "
238844|NCT00428987|"~     This study will describe the phenotype (physical and behavioral traits) of overweight and~     obese people. It will characterize the hormones, metabolism, food preferences, fitness and~     physical activity levels, sleep patterns and thought processes in people with and without~     weight problems. Genetic material will be collected for studies of the internal codes that~     influence body weight.~      People over 18 years of age from all weight categories (lean, overweight, obese) who are~     reasonably healthy may be eligible for this study. Participants undergo the following tests~     and procedures:~        -  Physical exam, electrocardiogram, blood and urine tests, instructions for recording food~          intake for 7 days~        -  Metabolic studies for menstruating women.~        -  Resting metabolic rate to study how many calories the body burns at rest.~        -  Mixed meal test to measure hormones such as insulin that regulate blood sugar.~        -  Glucose tolerance test to determine how sensitive the body is to insulin.~        -  24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of~          carbon dioxide breathed out.~        -  Repeat 24-hour energy expenditure.~        -  Diurnal blood sampling and temperature assessment to study the body s internal clock.~        -  Air-displacement plethysmography (Bod Pod) to measure body composition.~        -  Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density.~        -  Repeat Bod Pod and DEXA.~        -  Anthropometric measurements and bioelectrical impedance to measure height, weight, and~          circumferences, skinfold thickness, fluid status and percentage body fat.~        -  Bromide dilution to measure the amount of water not in cells in the body.~        -  Doubly labeled water to measure the amount of calories burned in a 7-day period.~        -  24-hour diet reports.~        -  Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing~          cardiovascular health.~        -  Treadmill or bicycle exercise capacity test.~        -  Physical activity monitor.~        -  Unicorder to detect any breathing difficulties that may interfere with sleep.~        -  Fat and muscle biopsy to look for variations in gene expression in fat tissue and~          muscle.~        -  Neurocognitive testing to check memory, decision-making, hand-eye coordination, and~          reasoning.~        -  Evaluation of mood problems and assess personality type.~        -  Evaluation to assess the quantity and quality of pain experienced.~        -  Taste testing to determine the response to bitter, salty, sweet and sour substances.~        -  Occupational therapy evaluation to explore the subject s adaptations, if any, for~          performing personal, social or professional activities; the subject s views on his or~          her weight, body size and shape, and strategies to control weight.~   "
238845|NCT00428974|"~     This study will test the hypothesis that CF101, which is under development to treat other~     immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of~     chronic plaque psoriasis. Patients with psoriasis who qualify for the study will be treated~     every 12 hours (q12h) with CF101 capsules, or placebo capsules, for 12 weeks. The safety of~     treatment will be carefully assessed through clinical and laboratory monitoring. The effect~     of treatment on psoriasis will be evaluated through standard techniques of examination and~     measurement of the severity of skin involvement.~   "
238846|NCT00428961|"~     Previous scientific research has found multiple genes that affect the risk for developing~     heart disease or complications during the treatment of heart disease. Less is currently known~     about how patients with heart disease may differ on the basis of other ailments they may have~     and how these other ailments may affect their treatment and prognosis. For this reason,~     researchers at the Mid America Heart Institute are conducting this research to find out how~     genes affect heart disease and recovery following angioplasty. The study will include~     patients with diabetes in order to determine if their genes are different from patients~     without diabetes.~      A total of 1,607 patients were enrolled. There were 2 groups of patients selected for this~     study. The first group of patients included into the study will be those that are scheduled~     to have a diagnostic angiogram only. The second group of patients were those that had along~     with the angiogram a percutaneous transluminal coronary angioplasty, PTCA and or the use of a~     device called a coronary stent, designed to help prop open the artery and to help avoid~     collapse. Samples for both groups will be stored for 30 years. After this time, all samples~     will be destroyed. Ultimately, we are hopeful that we will identify genes that will identify~     groups of patients at risk for heart disease.~   "
238847|NCT00428948|"~     This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus~     placebo in patients with ADPKD.~   "
238848|NCT00428935|"~     The purpose of this study is to determine the safety of a miniature dystrophin gene in the~     treatment of progressive muscle weakness due to Duchenne Muscular Dystrophy (DMD).~   "
238849|NCT00428922|"~     The primary objectives are to determine the progression-free survival (PFS) and to evaluate~     safety of the trastuzumab, bevacizumab and docetaxel regimen.~   "
238850|NCT00428909|"~     A non-randomized, open-label study to investigate the effects of imatinib mesylate on the~     pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously~     untreated chronic myeloid leukemia in chronic phase (CML-CP)~   "
238851|NCT00428896|"~     Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach~     with potential application in the treatment of human breast cancer. Therefore it could be~     very important and clinically relevant to know if ZD1839 is capable of eliminating occult~     tumour cells circulating in the blood of breast cancer patients~   "
238852|NCT00428883|"~     -  Systemic sclerosis (scleroderma; SSc) is a rare, disfiguring systemic disorder~          characterized by fibrosis of the skin and visceral organs that alters every aspect of an~          individual life~        -  Although some features of scleroderma phenotype are well established and represent the~          hallmarks of the disease, the primary cause is not fully delineated, though both~          endothelial cell damage, immunological abnormalities and excessive extracellular matrix~          production are well-documented~        -  Recently, excessive oxidative stress has been implicated in the pathogenesis of~          scleroderma~        -  N-acetylcysteine (NAC) exhibits direct and indirect antioxidant properties. Its free~          thiol group is capable of interacting with the electrophilic groups of ROS. This~          interaction with ROS leads to intermediate formation of NAC thiol, with NAC disulphide~          as a major end product. The net result is a decrease of the concentrations of OH-, H2O2,~          and HOCl. In addition, NAC exerts an indirect antioxidant effect related to its role as~          a glutathione (GSH) precursor. It serves as a central factor in protecting against~          internal toxic agents.~        -  In view of these considerations we expect that NAC can confer substantial benefit in~          patients with scleroderma reducing skin fibrosis in view of its antioxidant properties,~          and we have decided to conduct a double blind, multicenter trial to establish whether~          NAC could ameliorate skin fibrosis in scleroderma patients~   "
238853|NCT00428870|"~     Shoulder impingement syndrome is common and number of operations done per year is growing.~     The aim of this study is to compare the value of arthroscopic subacromial decompression~     (acromioplasty group) vs. diagnostic arthroscopy (control group) vs. supervised exercise~     therapy (conservative group) on subjects with chronic subacromial impingement syndrome. The~     results of treatment are measured at 3 months, 6 months, 12 months and 24 months. Main~     outcome measures are Pain at rest and activity (VASs), functional assessment of the shoulder~     with Constant score and Simple Shoulder test (SST), global assessment of change , quality of~     life assessment (SF-36 and 15D) and costs.~   "
238854|NCT00428857|"~     Rationale: respiratory complications are the most frequent complications following lung~     resection and represent a noticeable cause of mortality. Benefits from non-invasive~     ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of~     preventive NIV after lung resection, in the absence of acute respiratory failure and/or~     hypercarbia, could be justified by the physiological benefits expected. The goal of this~     study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for~     prevention of respiratory complications.~      Material and Methods: This is a prospective randomised multicenter trial with an open~     parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for~     lung resection.~      Expected results: This study will determine whether post-operative NIV decreases the~     incidence of acute respiratory events (acute respiratory failure) and whether some subgroups~     of patients benefit more from this strategy.~      Conclusion: This study should help evaluating the utility of post-operative NIV after lung~     resection.~   "
238855|NCT00428844|"~     This is a research study designed to look at the efficacy and safety of daptomycin given at a~     dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections~     caused by Staphylococci. These types of bacteria are among the most common types of bacteria~     causing infections of prosthetic joints.~   "
238856|NCT00428831|"~     The main purpose of this study is to look at relationships between types of flu viruses and~     characteristics of infected patients, including vaccination status, organ system involvement,~     and disease severity. In this study, 500 patients with respiratory illnesses will have~     nose/throat fluid samples collected. At Children's Hospital Boston, patients 30 days to 5~     years of age will be recruited; at Beth Israel Deaconess Medical Center, patients of any age~     will be eligible. The researchers will compare the symptoms of infection by similar flu virus~     types and look at differences in the flu virus types between the 2 age groups of patients.~     The researchers will also look at whether any flu virus types first show up in the children~     prior to infecting the adults. Hopefully this study will improve understanding of how flu~     viruses develop, spread, and cause disease. This information may help the development of more~     effective flu vaccines, prevention measures, and treatments.~   "
238857|NCT00428818|"~     Background: In many communities, skin and soft tissue infections (SSTI) with MRSA have become~     more prevalent than infections with β-lactam susceptible bacteria. This has necessitated~     altered empiric antimicrobial therapy of SSTI to cover MRSA.~      Objective: To evaluate empiric therapy with trimethoprim-sulfamethoxazole or doxycycline for~     outpatient SSTI in an area of high MRSA prevalence.~      Design: Randomized, prospective, open-label investigation. Setting: Emergency Department of~     Parkland Hospital in Dallas, Texas. Patients: Adults with SSTI. Intervention: Empiric oral~     therapy with trimethoprim-sulfamethoxazole (160 mg/800 mg, twice daily) or doxycycline (100~     mg, twice daily).~      Measurement: The primary endpoint was clinical failure defined as hospitalization or change~     in antibiotic therapy over the 10 to 14 days after initial emergency department evaluation.~   "
238858|NCT00428805|"~     Child Health Initiative for Lifelong Eating and Exercise (CHILE) is a trans-community~     multidisciplinary site-specific intervention and evaluation plan for a Head Start and~     family-based culturally and developmentally appropriate intervention. The primary goals are~     to increase physical activity and improve dietary intake through increased consumption of~     fruits, vegetables and whole grain and decrease consumption of sweetened drinks and high-fat~     foods,decrease television and other screen time, and decrease obesity in three to five year~     old Hispanic and American Indian children enrolled in Head Start programs in rural New~     Mexico. The trans-community intervention includes: A classroom curriculum for children; an~     in-service training program for Head Start teachers and educational aides; a school food~     service component; a family intervention; a community leader/local health care provider~     component; and a grocery store component.~      Participants include 16 Head Start programs serving Hispanic and Native American children and~     families from underserved communities in rural New Mexico. This is a randomized trial with an~     Intervention Condition and Control Condition. One cohort of three-year old Head Start~     students will be followed and measured for two years. During the two years in Head Start~     those children, their teachers, and families enrolled in the Intervention Condition will~     receive a program of activities to modify their dietary, physical activity, and screen~     viewing behaviors. Also addressed are the Head Start and community environments and policies,~     local grocery stores, and health care providers.~      CHILE uses an ecological framework including social cognitive theory, intervention mapping,~     environmental and policy changes, developmental theory, and sound educational practices. The~     approach includes in from the community to ensure acceptability, cultural appropriateness,~     feasibility, sustainability, and later transferability to similar communities.~      The primary outcome measures include changes in physical activity levels, dietary fiber~     intake, dietary fat intake, intake of sugared drinks, television viewing and other screen~     time, in BMI. Secondary measures include changes in the Head Start and community environments~     and policies related to physical activity, school food service, school snacks, and~     availability of healthful options. We will also examine the role of community leaders,~     especially health care providers, in raising awareness and creating a supportive and~     sustainable environment for the prevention of obesity.~   "
238859|NCT00428792|"~     This study evaluated the safety and clinical effect of treatment with methylphenidate under~     different breakfast conditions (minimal breakfast versus standard continental breakfast) in~     children with Attention-Deficit Hyperactivity Disorder (ADHD).~   "
238860|NCT00428779|"~     The main purpose of the present study is to determine the relative contributions of central~     and peripheral fatigue during an ultra-endurance exercise.~   "
238861|NCT00428766|"~     The purpose of this study is to establish the safest dose of MORAb-003 in subjects with~     advanced ovarian cancer. MORAb-003 is an antibody directed to an antigen on the surface of~     ovarian cancer cells.~   "
238862|NCT00428753|"~     This study will determine risk factors of human infection with avian influenza A virus, also~     known as bird flu virus. Certain risk factors such as exposure to poultry, travel history,~     health status, and other factors may affect one's risk of getting bird flu. Study~     participants will include individuals, older than age 1, that tested positive for influenza A~     (H5N1) in a previous surveillance program and controls (individuals that have not tested~     positive for avian influenza A (H5N1) and have no fever or respiratory symptoms). There will~     be 1 study visit during which volunteers will be asked detailed questions about their health,~     work, and travel habits. Study participants will be asked to donate a blood sample to test~     for antibodies, the part of the blood that fights infection.~   "
238863|NCT00428740|"~     Long-term intraocular pressure (IOP) fluctuation may be significantly associated with the~     progression of glaucomatous visual field loss, even in patients kept always low IOP after~     triple procedure, an effective approach for patients with coexisting glaucoma and visually~     significant cataracts.~   "
238936|NCT00427752|"~     This study is being conducted to determine whether an endoscope, (a small, flexible tube with~     a camera mounted on the end) passed down through the throat, through the stomach, and into~     the abdomen can safely and accurately examine the organs and tissue of the abdomen and take~     biopsies if needed. We wish to determine if this endoscopic diagnostic route is as efficient~     as the laparoscopic diagnostic route, which is currently the standard of care.~   "
239708|NCT00417521|"~     This trial seeks to investigate the feasibility and effectiveness of delivering a newly~     manualized family-based treatment for adolescents with anorexia nervosa~   "
238864|NCT00428727|"~     Diabetes Mellitus constitutes one of the most important public health problems due to its~     high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one~     of the chronic complications of diabetes mellitus and constitute the most important cause of~     non-traumatic amputation of inferior limbs. It is estimated that 15% of diabetic population~     will develop an ulcer sometime in their life. Although novel therapies have been proposed,~     there is no effective treatment for this pathology. Naturally produced nitric oxide~     participates in the wound healing process by stimulating the synthesis of collagen,~     triggering the release of chemotactic cytokines, increasing blood vessels permeability,~     promoting angiogenic activity, stimulating the release of epidermal growth factors, and by~     interfering with the bacterial mitochondrial respiratory chain. Topically administered nitric~     oxide has demonstrated to be effective and safe for the treatment of chronic ulcers secondary~     to cutaneous leishmaniasis. However, due to their unstable nitric oxide release, the topical~     donors needed to be applied frequently, diminishing the adherence to the treatment. This~     difficulty has led to the development of a multilayer polymeric transdermal patch produced by~     electrospinning technique that guarantees a constant nitric oxide release. The main objective~     of this study is to evaluate the effectiveness and safety of this novel nitric oxide~     releasing wound dressing for the treatment of diabetic foot ulcers.~      A double-blind, placebo-controlled clinical trial, including 100 diabetic patients was~     designed. At the time of enrollment, a complete medical evaluation and laboratory tests will~     be performed, and those patients who meet the inclusion criteria randomly assigned to one of~     two groups. During 90 days group 1 will receive active patches and group 2 placebo patches.~     The patients will be seen by the research group at least every two weeks until the healing of~     the ulcer or the end of the treatment. During each visit the healing process of the ulcer,~     the patient's health status and the presence of adverse events will be assessed. Should the~     effectiveness of the patches be demonstrated an alternative treatment would then be available~     to patients.~   "
238865|NCT00428714|"~     The purpose is to see how quickly two different types of prostate cancer patients respond~     when taking enzastaurin.~      Cohort 1 - asymptomatic patients with androgen-independent PSA-progressive disease with or~     without clinical or radiographic evidence of metastatic disease.~      Cohort 2 - patients with androgen-independent metastatic prostate cancer (documented bone or~     soft tissue metastases) with rising PSA, clinical, radiographic disease progression following~     one prior docetaxel-based regimen~   "
238866|NCT00428701|"~     This study is being done to see if Nexium I.V. can reduce and control stomach acid in~     mechanically ventilated, critically ill patients in an Intensive Care Unit setting.~   "
238867|NCT00428688|"~     The aim of the proposed study is to assess endothelial function and IMT, as correlates of~     cardiovascular disease (CVD), in young adult Hodgkin's disease (HD) survivors, and to relate~     endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia~     and fasting glucose.~   "
238868|NCT00428675|"~     Fatigue is a common problem in advanced cancer and palliative care. The development of tools~     to measure fatigue, however, has been slowed by their inability to distinguish between~     fatigue and other related symptoms, such as tiredness. Our work suggests that these~     distinctions are important because they serve as markers for stressors associated with~     advancing disease. We have developed a tool that we believe will distinguish between these~     two states as well as exhaustion. In this study we will conduct some initial tests of this~     tool in preparation for its use as an outcome indicator in future studies.~   "
238869|NCT00428662|"~     Coronary artery disease (CAD) is the largest cause of death and disability in the world.~     Besides medicines, the principle treatment of this condition requires opening of the narrowed~     arteries, responsible for angina and other symptoms of the disease, by angioplasty or~     surgery. Introduction of metal scaffolds called 'stents' in the past few decades~     revolutionised the angioplasty technique, and has made it the most popular treatment today~     for CAD. However these stents are prone to becomin narrow and obstructed after implanataion,~     causing symptoms and non-fatal heart attacks in some patients. Introduction of stents that~     slowly release drugs locally to minimize this process, called 'drug-eluting stents'(DES)he~     past few years has been one of the biggest breakthroughs in the field of cardiology. However~     ven the current available DES are still prone to narrowing in high-risk patients, like those~     with diabetes, and also have a higher chance for sudden blockage by a blood clot even many~     years later after insertion. Thus it is important to develop technology for more efficacious~     and safer DES.This includes safer drugs, better stent design and delivery, and more inert~     platforms for drug release We hypothesise that a new stent made with nanoporous particle with~     better polymer for drug release will prove to be safer and more efficacious alternative to~     currently available DES.~   "
238870|NCT00428649|"~     The purpose of this study is to determine the amount of selenium as selenomethionine that is~     required to optimize selenoprotein P in selenium-deficient Chinese subjects~   "
238871|NCT00428636|"~     We conducted a prospective randomized study to evaluate the results of early closure of~     temporary loop ileostomy at eight days in comparison with late closure at two months, after~     elective rectal resection with low pelvic anastomoses.~   "
238872|NCT00428623|"~     The study is a prospective randomised, controlled study of 136 patients undergoing vascular~     surgery. Their closed wounds were covered with either aquacel, a hydrofiber dressing, or a~     traditional gauze dressing.Number of changes, patient comfort,number of infections, length of~     hospital stay and wound complications were compared between the two groups.~   "
238873|NCT00428610|"~     The primary objective is to determine whether LY573636-sodium (hereafter referred to as~     LY573636) is effective in treating platinum-resistant ovarian cancer. Patients will receive~     an intravenous infusion of study drug once every 28 days. Computed tomography (CT) scans and~     CA-125 tests will be done before the first dose and then after every other treatment.~   "
238874|NCT00428597|"~     This study randomized patients with advanced pancreatic islet cell tumors to receive either~     sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib~     daily, those randomized to placebo received a tablet that looked similar but had no active~     drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or~     placebo. Patients were followed to determine the status and size of their tumors, survival,~     quality of life and safety of the drug.~      The study was designed to detect a 50% improvement in median PFS[Progression Free Survival]~     with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130~     events had occurred, and the final analysis was to be conducted when 260 events had occurred.~      Study A6181111 was stopped early during the enrollment period because of a clear and~     clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended~     by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and~     the actual number of PFS events recorded was 81 PFS events. The decision to terminate the~     study was not based on safety concerns related to sunitinib administration.~   "
239709|NCT00417508|"~     The purpose of this study is to investigate whether nutritional supplementation will improve~     functional outcome parameters and nutritional status in elderly patients.~   "
238876|NCT00428571|"~     A large number of research studies on people who were morbidly obese (extremely overweight),~     and had bariatric surgery (anti-obesity surgery) have shown that patients who were diabetic~     before surgery often experienced significant improvement in their diabetes following the~     surgery. For some patients, blood glucose levels returned to the normal range, and they were~     able to stop taking all of their diabetes medications. For others, blood glucose levels~     improved, allowing them to reduce their diabetes medications.~      This research study is being done to determine whether bariatric surgery can safely provide~     better control of diabetes symptoms in obese diabetics than continuing medical management~     (anti-diabetic drugs in combination with diet and lifestyle changes).~      There are several different types of bariatric surgery currently being used to treat morbid~     obesity. Two of the most common techniques are gastric bypass and adjustable gastric banding.~     This study will be comparing these two surgical techniques to treatment with a combination of~     drugs, diet, and lifestyle changes for control of type 2 diabetes.~   "
238877|NCT00428558|"~     Core binding factor (CBF) acute myeloid leukemias (AML) include AMLs carrying the t(8;21)~     translocation as well as AMLs carrying either the inversion of chromosome 16 or translocation~     t(16;16). CBF-AMLs are characterized by their high sensitivity to standard chemotherapeutical~     agents, especially to cytarabine when administered as high-dose bolus infusions, and thus by~     a relative good prognosis. However, relapse rates are still comprised between 30 and 50% in~     these patients, even if overall survival may reach approximately 65% due to the potential~     salvage of late relapses.~      The primary purpose of the protocol is to compare two modalities of timed-sequential~     induction in order to improve the results of the treatment of CBF-AML patients. This protocol~     also includes the biological characterization of the heterogeneity of these diseases (gene~     mutation and transcription profiles), as well as a centralized minimal residual disease~     monitoring and centralized evaluation of pharmacogenetic polymorphisms.~   "
238878|NCT00428545|"~     The goal of this clinical research study is to find the highest tolerable dose of Avastin™~     (bevacizumab) and Velcade™ (bortezomib) that can be given in combination to patients with a~     metastatic or unresectable advanced malignancy. The safety and effectiveness of this drug~     combination will also be studied.~   "
238879|NCT00428532|"~     The study will check whether taking 100 mg of licorice root extract or 250 cc of pomegranate~     juice daily by men with diabetes mellitus who are non-smokers and already treated with~     statins decreases the risk of developing atherosclerosis. The hypothesis of the study is that~     natural anti-oxidants (such as licorice root extract and pomegranate juice), by scavenging~     free radicals, retard and may even reverse atherosclerosis.~   "
238880|NCT00428519|"~     The investigators' in vitro data suggest that Neurokinin-1 receptor antagonists like~     aprepitant will decrease the expression of CCR5, an essential co-receptor in the life cycle~     of HIV, in the surface of macrophages and lymphocytes to levels at least similar to those~     observed in patients heterozygous for the CCR5 32 mutation. Together with a direct potential~     antiviral effect this could alter disease progression in patients with HIV infection.~      The investigators' hypothesis is that aprepitant is safe, tolerable and has antiviral~     activity in HIV infected individuals.~      This is randomized, placebo controlled, double blind study to determine the safety and~     antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks~     of aprepitant monotherapy.~      27 HIV infected males and females ≥ 18 years old who have early infection with CD4 cell~     counts ≥ 350 cells/mm3. Subjects will be randomized 1:1:1 to receive two different doses of~     aprepitant (Emend®) or placebo.~   "
238881|NCT00428506|"~     The purpose of this study is to determine whether the infusion of albumin 4 gr per liter of~     ascites removed is as effective as the infusion of albumin 8 gr per liter of ascites removed~     in the prevention of post-paracentesis circulatory dysfunction~   "
238882|NCT00428493|"~     The purpose of this study is to see if people in China who have contact with someone infected~     with bird flu (H5N1) become infected themselves without necessarily getting sick. Adults and~     children greater than 1 year of age who have contact with someone infected with bird flu may~     participate in the study. At the first 1-2 study visits, a blood sample will be taken from~     volunteers in order to test for antibodies, the part of the blood that fights infection. If~     the result of the H5N1 antibody test is positive after the 1st or 2nd study visit, an~     additional blood sample will be collected during a 3rd and 4th study visit. Volunteers will~     be asked questions about their work, home life, and possible contact with poultry, other~     birds, animals, and people infected with bird flu. Participants will be involved in study~     related procedures for up to 90 days.~   "
238883|NCT00428480|"~     The primary purpose of this study is to determine the effects of reinforcement of walking~     speed on recovery of walking speed over the course of inpatient rehabilitation for people~     after stroke. The study will also examine the relationship between short distance walking~     speed and walking distance over a fixed time.~   "
238884|NCT00428467|"~     The current study analyses the LV geometry of failing LVs measured by MRI scanning with~     respect to systolic versus diastolic function. A new surgical method for remodelling enlarged~     left ventricles is introduced.An apical remodelling stitch led to significant remodelling~     which was accompanied by improvement in ventricular function.~   "
238885|NCT00428454|"~     Primary intracoronary stent placement after successfully crossing chronic total coronary~     occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with~     conventional balloon angioplasty. Several studies have shown the efficacy of~     sirolimus-eluting stents in selected groups of patients. In the PRISON II study we~     demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO. In this~     prospective randomized trial, sirolimus-stent implantation will be compared with~     zotarolimus-eluting stent implantation for the treatment of chronic total coronary~     occlusions. A total of 300 patients will be clinically followed up for 1, 6, 12 months, 2, 3,~     4, 5 year with angiographic follow-up at 8 months. Quantitative coronary analysis will be~     performed by an independent core laboratory. The primary end point is in-segment late luminal~     loss at 8 month angiographic follow-up.~   "
238952|NCT00427544|"~     The primary purpose of this study is to asess the safety and tolerability of ascending single~     oral doses of PRA-027 in healthy women of nonchildbearing potential. The secondary purpose is~     to provide the initial pharmacokinetic (PK) and pharmacodynamic (PD) profile of PRA-027 in~     healthy women of nonchildbearing potential, and to evaluate the effect of a high-fat meal on~     the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential.~   "
238886|NCT00428441|"~     Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous~     thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate~     evidence. More than 12 months of treatment are currently recommended, and the grade of~     recommendation is low.~      The PROLONG study has recently evaluated the predictive role of D-dimer measurement after~     withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients~     with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients~     with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the~     results of this and of previous cohort studies, it appears safe to withhold treatment in~     patients with negative D-dimer values and to continue treatment in patients with altered~     D-dimer levels.~      Aim of this study is therefore to assess the negative predictive value of D-dimer also in~     patients with recurrent VTE and to evaluate the clinical utility of this approach in this~     patient setting.~   "
238887|NCT00428428|"~     The purpose of the study is to examine the effect of endoluminally administrated~     isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We~     propose that isoproterenol has potential of reducing intrarenal pressure during~     ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the~     procedure and reducing intraoperative complications as bleeding and infections.~   "
238888|NCT00428415|"~     Purpose:~      To evaluate the effect of tesofensine on energy balance~   "
238889|NCT00428402|"~     The MIDAS Project (Models of Implementation and Dissemination of Environmental Health and~     Science Across Subjects) Assessment Objectives:~        -  Determine whether students are aware of the MIDAS Project.~        -  Identify strengths and weaknesses of MIDAS Project components including: integrated~          environmental health and science (EHS) curricula, field experiences, seminars and~          student projects.~        -  Assess career interests and intended courses of study at the college level.~   "
238890|NCT00428389|"~     This study was designed to evaluate the safety and tolerability of switching from donepezil~     to an initial dose of 5cm^2 rivastigmine patch formulation in patients with probable~     Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period~     followed by a 20-week open-label extension period. Patients were randomized to either an~     immediate switch from donepezil to rivastigmine patch formulation or to a switch to~     rivastigmine patch formulation following a 7-day withdrawal period.~   "
238891|NCT00428376|"~     This is a randomized controlled trial of distributing blocks to children ages 1.5 -2.5 years~     of age to see if language acquisition improves.~   "
238892|NCT00428363|"~     Purpose: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp~     posterior optic edge design of the Clariflex silicone intraocular lens (IOL) with that of the~     double-round edge design of the SI40 (Phacoflex) silicone IOL over a period of 3 years.~      Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.~      Methods: Fifty-two patients with bilateral age-related cataract (104 eyes) were included in~     this randomized, prospective, bilateral, patient- and examiner-masked clinical trial with~     intra-individual comparison. Each study patient had cataract surgery in both eyes and~     received an SI40 IOL (anterior and posterior round optic edges) in one eye and a Clariflex~     IOL with OptiEdge (round anterior and sharp posterior optic edge) in the other eye. Follow-up~     examinations were at one week, one month, six months, one, two, and three years. Digital~     retroillumination images were taken of each eye. The amount of PCO was assessed subjectively~     at the slit-lamp and objectively using automated image analysis software (AQUA) one, two, and~     three years after surgery.~   "
238893|NCT00428350|"~     The primary objective of the study is to evaluate the efficacy of quetiapine fumarate~     (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute~     schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day~     56 using the last observation carried forward (LOCF) method.~   "
238894|NCT00428337|"~     The purpose of this study is to determine the safety of and immune response to two~     experimental vaccines, designed for use in combination, for the prevention of HIV infection~     in healthy adults.~   "
238895|NCT00428311|"~     Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting~     with the polycystic ovary syndrome - in association with insulin resistance, obesity, and~     other metabolic disorders.~      The present clinical trial intends to compare the effects of oral contraceptives and~     metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers~     and indexes of cardiovascular performance, in order to whether or not, as suspected by~     previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the~     cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter~     actually ameliorates such a risk.~   "
238896|NCT00428298|"~     This is a sixteen week, randomized, double-blind add-on study of valacyclovir versus placebo~     in approximately 60 outpatients meeting diagnostic criteria according to the Diagnostic and~     Statistical Manual of Mental Disorders (DSM) -IV Bipolar I or II disorder, testing positive~     for HSV-1 and who have demonstrable cognitive impairment defined as a total score of less~     than 85 (one standard deviation from the normal range) on the Repeatable Battery for the~     Assessment of Neuropsychological Status (RBANS). Each patient will be randomized to~     double-blind treatment with either valacyclovir or placebo for sixteen weeks. All subjects~     will be maintained on a stable regimen of psychiatric drugs prescribed by their treating~     psychiatrist. Patients will be evaluated every 2 weeks by the treatment team and mood rating~     scales will be administered at each visit including the Young Mania Rating Scale (YMRS) and~     the Montgomery Asberg Depression Rating Scale (MADRS). The RBANS will be administered again~     at 8 and 16 weeks. Both the treatment team and the patient will remain blinded during the~     course of the study. Following the active treatment phase, patients will receive treatment as~     clinically indicated.~      Primary Hypothesis:~      Valacyclovir will be superior to placebo in reducing cognitive symptoms associated with~     bipolar disorder in subjects who have been previously infected with Herpes Simplex virus I~     (HSV-1).~      Secondary Hypothesis:~      Valacyclovir will be superior to placebo in reducing mood symptoms associated with bipolar~     disorder in subjects who have been previously infected with HSV-1.~   "
238897|NCT00428285|"~     The purpose of this study is to assess if argon plasma coagulation (APC) is a safe and well~     tolerated treatment method for anal intraepithelial neoplasia (AIN) grade 2/3 in HIV-positive~     men having sex with men (MSM).~   "
238898|NCT00428272|"~     Background~        -  HGS-ETR2 is a monoclonal antibody, produced in the laboratory from human genes.~        -  HGS-ETR2 targets a protein called the TRAIL receptor that is located on the surface of~          some tumor cells. When the TRAIL receptor is activated, it can cause the tumor cell to~          self-destruct.~      Objectives:~        -  To determine the highest dose of HGS-ETR2 that can be given safely in children and young~          adults with cancer.~        -  To study the pharmacology (how the body handles the drug) of HGS-ETR2 by measuring the~          amount of drug in the bloodstream over time before and after a dose is given to the~          patient.~        -  To determine if HGS-ETR2 can stop or slow tumor growth.~        -  To determine whether proteins in tumor tissue before treatment can predict whether the~          tumor will respond to HGS-ETR2 therapy.~      Eligibility:~      -Patients 1 to 21 years of age with solid cancers that do not respond to standard therapy.~      Design:~        -  HGS-ETR2 is given through a vein (intravenously, IV) once every 14 days. Each treatment~          cycle is 28 days long and consists of two doses of HGS-ETR2.~        -  The dose of HGS-ETR2 is increased in successive small groups of patients until the~          maximum tolerated dose (highest dose with acceptable side effects) is determined.~        -  During the treatment period, patients have a physical examination at least once a week,~          and routine blood tests at least twice a week. These tests are done less frequently in~          later treatment cycles.~        -  Additional blood samples are drawn for immunology and pharmacology studies.~        -  Tests to monitor the size of the tumor (X-rays, CT scans, MRI, PET scans) are done~          periodically throughout the treatment period.~        -  Patients may continue to receive HGS-ETR2 until unacceptable side effects develop or the~          tumor grows.~   "
238899|NCT00428246|"~     The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation,~     blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become~     abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The~     purpose of this study is to determine if paricalcitol helps improve kidney injury, blood~     pressure control and kidney function in patients with chronic kidney disease. The study will~     last about 7 weeks and involves about 8 visits to the medical center.~   "
238900|NCT00428233|"~     The purpose of this research study is to collect, freeze and store leukemia cells from the~     blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that~     is not in clinical remission. This study is a companion study to DF/HCC clinical trial 06-196~     in which the participants' own CLL cells may form part of a vaccine treatment for their~     leukemia.~   "
238901|NCT00428220|"~     This is a study using sunitinib for patients ending treatment on a previous sunitinib malate~     protocol to continue to receive sunitinib. The patient must have been enrolled in one of the~     following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108,~     A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer~     sponsored sunitinib studies may be included in the future.~   "
238902|NCT00428207|"~     The purpose of this study is to determine:~        1. whether there is a difference between insulin aspart and insulin lispro in continuous~          insulin pump therapy~        2. whether duration of the insulin infusion set placement effect blood sugar control if the~          infusion set is in place for longer then 72-96 hours~   "
238903|NCT00428194|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib and~     cisplatin may make tumor cells more sensitive to radiation therapy. Giving erlotinib together~     with cisplatin and radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when~     given together with cisplatin and radiation therapy in treating patients with stage IB, stage~     II, stage III, or stage IVA cervical cancer.~   "
238904|NCT00428181|"~     The purpose of this study is to determine whether a booster session is needed after a brief~     intervention upon initial admission to the emergency room (ER) in order to reduce the rate of~     alcohol-related injury recidivism.~   "
238905|NCT00428168|"~     This is a randomized, double-blind, placebo-controlled, multicenter, multinational study.~     Approximately 78 subjects (39 per treatment group) will be randomized into this 16 week~     study.~      A screening visit will be used to determine subject suitability for inclusion in the trial.~      Within 7 days of the screening visit, subjects who meet all inclusion criteria and none of~     the exclusion criteria will be randomly assigned to 1 of the following 2 treatment groups:~        -  Olanzapine OD plus betahistine 24 mg BID (48 mg/day total),~        -  Olanzapine OD plus matching placebo BID.~      Double-blind treatment will continue for 16 weeks. During this period, olanzapine dosage will~     be determined according to the discretion of the treating physician. In addition, 5 study~     visits (at 2, 4, 8, 12, and 16 weeks) will take place. Study medication (betahistine or~     matching placebo) will be administered BID (in the morning and together with olanzapine in~     the evening).~      The primary statistical hypothesis to be tested is that the mean change from Baseline to Week~     16 will be different between the treatment and placebo groups~   "
238906|NCT00428155|"~     PCI (coronary angioplasty) is a procedure performed through a catheter to open up blockages~     in the coronary arteries using balloons and stents for the treatment of angina or myocardial~     infarction. The balloon catheters and stents are moved to the coronary arteries through a~     “sheath” (a small tube used for placing of balloon and stent catheters in the body) placed in~     a major artery passing through the groin. After the PCI procedure and the removal of sheath,~     an “arterial closure device” is commonly placed to stop bleeding and allow you to get out of~     bed sooner. Although the usefulness of “closure devices” has been documented before their~     approval by the regulatory authorities, it is unclear if one device is better compared to~     other commercially available devices.~      The purpose of the study is to compare the two approved arterial closure devices, “Angioseal”~     and “Starclose”. This study will help us identify the better of the two devices to improve~     patient comfort after the procedure.~   "
238907|NCT00428142|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine,~     and prednisone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can~     block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Giving bortezomib together with combination chemotherapy and rituximab may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib~     together with combination chemotherapy and rituximab works when given as first-line therapy~     in treating patients with stage III or stage IV follicular non-Hodgkin's lymphoma.~   "
238908|NCT00428129|"~     A single centre, single-arm study to evaluate safety and efficacy of microplasmin~     administration via the Trellis-8 Infusion System in patients with acute iliofemoral DVT~   "
238909|NCT00428116|"~     Given the high mortality associated with infant HIV-1 and the fact that surrogate markers are~     poorly predictive of mortality risk,empiric highly active antiretroviral therapy (HAART)~     initiation is started in infants younger than 12 months. A problem with this approach is that~     it obligates infants to life-long therapy, which may be associated with cumulative drug~     toxicity, poor adherence, and treatment failure. Early HAART for prevention of mortality~     during the first 2 years of life has potential to salvage immune function and alter viral~     set-point, allowing withdrawal of therapy, perhaps for several years, until subsequent CD4%~     decline requires it. This untested approach is attractive because it combines the survival~     benefits of early pediatric HAART therapy with the benefits of antiretroviral deferral.~      One hundred and fifty infants who initiated HAART at <13 months of age will be treated with~     HAART regimen for 24 months after which those who have immune reconstitution and adequate~     growth (~100) will be randomized to continued versus deferred therapy. Clinical outcomes,~     growth, and toxicity will be compared in these children to determine if interruption is a~     safe and beneficial strategy. Follow-up in this studies will be closely monitored by an~     external Data Safety and Monitoring Board (DSMB).~   "
238910|NCT00428103|"~     The primary aim of this study is to assess the changes on the shape and function of the left~     ventricle in patients with severe mitral valve regurgitation due to congestive heart failure~     and cardiomyopathy who undergo mitral valve reconstruction with a Geoform ring.~     Three-dimensional echocardiogram will be used for precise evaluation of the shape and~     function of the ventricle.~   "
238911|NCT00428090|"~     Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes~     mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the~     investigational drug, is an extended-release form of RSG. This study tests whether RSG XR~     safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a~     new approach to AD therapy and this study tests whether one's genes alter the effectiveness~     of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the~     ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be~     lower in the brains of AD patients, and their brain cells may also use glucose less well than~     in unaffected people. The proper function of brain cells may be critical to memory and~     thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells~     properly use glucose may help a person maintain normal memory and thinking. Data suggesting~     that RSG may help AD patients was first seen in a small study at the Univ. of Washington and~     then from a larger international GSK study. In the first study, those receiving RSG once~     daily for 6 months scored better on 3 tests of memory and thought than those who did not~     receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a~     specific genetic pattern. They lacked the gene that caused them to produce apolipoprotein E~     e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent,~     or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE~     e3 version of the gene from one parent. Subjects with one copy of the APOE e4 gene remained~     fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month~     treatment. This study will directly test the effect of RSG XR on people who either have or~     lack the APOE e4 gene.~   "
238912|NCT00428077|"~     RATIONALE: Vaccines made from a peptide may help the body build an effective immune response~     to kill cancer cells.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients~     with chronic phase chronic myelogenous leukemia.~   "
238913|NCT00428064|"~     To assess equivalence in the rates of functional graft survival at 12 months after~     transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune,~     Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and~     concentration-controlled sirolimus.~   "
238914|NCT00428051|"~     The study will determine the reduction in invasive pneumococcal disease (IPD) after the~     introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study~     determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia.~     LEAP II is the continuation of the study in Colombia only.~   "
238915|NCT00428038|"~     The purpose of this study is to evaluate how easily gas can be taken up by the lung. We are~     comparing infants born premature <32 weeks gestation to infants born full term >37 weeks. We~     hope to evaluate the differences between the two groups in order to learn more about~     premature lung growth and development.~   "
238916|NCT00428025|"~     Inflammation of the pancreas (pancreatitis) is an uncommon but potentially serious~     complication of endoscopic retrograde cholangiopancreatography (ERCP), a specialized~     endoscopic examination of the ducts draining the liver and pancreas. Although many different~     strategies have been tried and studied in attempts to reduce this risk, few have been shown~     to make a significant difference. Those that have are either very expensive, difficult to~     administer, or both.~      Diclofenac, an anti-inflammatory medication most often used to treat arthritis, has shown~     potential to decrease the risk of post-ERCP pancreatitis. It can be given after the procedure~     to patients at most risk for the complication, and has few side effects. This study will~     randomize people in the study to placebo or active medication, to determine if Diclofenac~     reduces the incidence of pancreatitis.~   "
238917|NCT00428012|"~     The purpose of this study is to determine whether psychological intervention is effective in~     improving quality of life, mood, and relationships among adults with end-stage renal disease~     who are awaiting kidney transplantation.~   "
238918|NCT00427999|"~     The purpose of this study is to evaluate the efficacy, tolerability and safety of a~     multi-targeted therapy in patients with hormone-refractory prostate cancer.~   "
238919|NCT00427986|"~     The purpose of the present study is to examine, if retinal swelling in diabetic patients can~     be reduced by an intravenous injection of galactose.~   "
238920|NCT00427973|"~     This phase II trial is studying how well AZD2171 works in treating patients with locally~     advanced unresectable or metastatic liver cancer. AZD2171 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the~     tumor~   "
238921|NCT00427960|"~     The purpose of this study is to compare the effectiveness and safety of rosuvastatin 5mg in~     lowering blood cholesterol, compared to one other medicine, atorvastatin 10mg in Asian~     patients in the UK.~   "
238950|NCT00427570|"~     RATIONALE: Drugs used in chemotherapy, such as vincristine, fluorouracil, and semustine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Biological therapies, such as BCG, may stimulate the immune~     system in different ways and stop tumor cells from growing. It is not yet known whether~     combination chemotherapy is more effective than BCG in treating colon cancer that has been~     removed by surgery.~      PURPOSE: This randomized phase III clinical trial is studying giving fluorouracil together~     with semustine and vincristine to see how well they work compared with giving BCG in treating~     patients with Dukes' B or Dukes' C colon cancer that has been removed by surgery.~   "
238922|NCT00427947|"~     Analgesia following leg amputation is based on morphine administration. For elderly patients~     of ASA physical status 2 or 3, morphine sparing is possible when perinervous block techniques~     are used. Phantom limb pain complicates leg amputation in 50 to 80% of cases. Prevention of~     these pains has been studied in various clinical trials but the interest of perinervous block~     technique remains to be evaluated.~      The purpose of the study is to evaluate the benefit of perioperative locoregional analgesia~     by ropivacaine via a popliteal sciatic catheter on intravenous morphine consumption during~     the 72 first postoperative hours following leg (below knee) amputation The study will be~     randomized, double blinded, controlled clinical trial and 84 patients undergoing leg~     amputation (below knee) will be included Patients will be divided into 2 groups: one group of~     patients who will benefit perioperative locoregional analgesia by ropivacaine via a popliteal~     sciatic catheter and morphine for analgesia and the other one who will benefit placebo~     through the catheter and morphine.~      The investigators will evaluate the efficacy of the continuous popliteal sciatic nerve block~     in postoperative analgesia after leg amputation and prove the efficacy of a perioperative~     analgesia by continuous popliteal sciatic nerve block to prevent phantom limb pain after leg~     amputation in patients of ASA physical status 2 or 3.~   "
238923|NCT00427934|"~     The purpose of this study is to evaluate whether maraviroc, an investigational drug given~     with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in~     adult patients.~   "
238924|NCT00427921|"~     To make adalimumab available to subjects suffering from moderately to severely active Crohn's~     Disease (CD) and to expand the safety information on adalimumab. The study also assessed~     changes in Patient Reported Outcome Measures from baseline.~   "
238925|NCT00427908|"~     This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the~     vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in~     children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2~     years) as controls. In the long-term follow-up phase of the study, the long-term protection~     offered by the vaccines will be assessed up to 5 years after vaccination.~      Subjects will be randomized in the primary vaccination phase of the study; no new subjects~     will be enrolled during the long-term follow-up phase of the study.~   "
238926|NCT00427895|"~     This study will assess the safety, tolerability and immune response of 13-valent pneumococcal~     conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine~     (23vPS). Although the study started with only 1 population, amendments to the original~     protocol will now reflect three participant populations. Three age cohorts will be enrolled.~     The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49)~     are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart.~     Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS.~     Comparisons of immune responses from the different cohorts will be done.~   "
238927|NCT00427882|"~     Primary:~      To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or~     premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.~      Secondary:~        -  To evaluate sexual function improvement~        -  To evaluate LUTS (Lower Uninary Tract Symptoms) improvement~        -  To evaluate the association between LUTS severity and sexual function.~        -  To assess the safety and the tolerability of Alfuzosin 10mg OD.~   "
238928|NCT00427856|"~     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow~     unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis~     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process~     of cell death that is often inhibited in cancer cells.~   "
238929|NCT00427843|"~     The purpose of this study is to determine the influence of a home program of exercises for~     the hip muscles which support the pelvis on walking patterns and hip muscle strength in~     people with knee osteoarthritis. Following a hip muscle strengthening program, we hypothesize~     that participants with knee osteoarthritis will demonstrate decreased loading at the knee~     joint during walking and greater strength of the hip muscles.~   "
238930|NCT00427830|"~     This is a phase I study to examine the safety and immunogenicity of MVA85A delivered~     intradermally into the deltoid region in volunteers who have recieved BCG in the past 20~     years.~   "
238931|NCT00427817|"~     The main objective of this study is to realise serum protein profiles for each patient~     undergoing a prostate biopsy and to identify relevant proteins.~   "
238932|NCT00427804|"~     This study is a pilot study to determine whether patients with TNFα excess have decreased~     calcium absorption in response to calcitriol (1,25-dihydroxyvitamin D, the active form of~     vitamin D) compared to normal controls. This initial pilot study is being done to determine~     if it is feasible to conduct a study where TNFα could be blocked (e.g., by anti-TNFα therapy~     such as Enbrel® or Remicade®) to improve vitamin D dependant calcium absorption and thus bone~     health.~   "
238933|NCT00427791|"~     Primary Objective:~        -  To determine the progression free survival (PFS) of the preparative regimen rituximab,~          etoposide and total body irradiation (TBI), in patients with acute lymphoblastic~          leukemia (ALL) receiving allogeneic hematopoietic stem cell transplantation (SCT).~      Secondary Objectives:~        -  To determine the effect of rituximab on the incidence of acute graft vs. host disease~          (GVHD).~        -  To determine the efficacy of adding imatinib mesylate post transplant in ALL patients~          with the t(9;22)(q34;q11) cytogenetic abnormality.~        -  To estimate the probability of molecular complete remission at one year for the~          described treatment approach as determined by serial minimal residual disease (MRD)~          monitoring.~        -  To determine the rate of GVHD, engraftment, toxicity, and overall survival (OS) for this~          treatment regimen.~   "
238934|NCT00427778|"~     This study aims as defining success rate of the incontinence ring in women with test proven~     stress urinary incontinence and determining factors associated with successful use.~   "
238951|NCT00427557|"~     The goal of this clinical research study is to learn if giving umbilical cord blood along~     with standard stem cells after high-dose chemotherapy will improve the response to a stem~     cell transplant. The safety of this treatment will also be studied.~   "
238953|NCT00427531|"~     RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using~     a skin conduction device or by using a diary.~      PURPOSE: This clinical trial is studying a skin conduction device and a patient diary for~     measuring hot flashes in postmenopausal women with hot flashes.~   "
238937|NCT00427739|"~     At present, there is not accurate way to determine specific flow rates for axial flow~     ventricular assist devices (VADS). If a right heart cath is needed for these patients for~     clinical purposes, they will also undergo a cardiac CT scan while the pulmonary artery~     catheter is in place. It is possible to visualize the flow rates of axial flow VAD's and~     determine a more accurate rate per specific patient.~      Data Analyzed with following results:~      Article in Press for Cardiopulmonary Support and Physiology, results state Pairwise~     comparison of calculated output from left ventricular assist devices is feasible using first~     pass dynamic computed tomography test bolus technique versus thermodilution output~     measurements yielded good agreement (P=.03). The output calculated using dynamic CT~     underestimated the thermodilution output measurement by 0.54+ 0.37 L/min (95% confidence~     interval 0.66-0.94).~   "
238938|NCT00427726|"~     This study will provide follow-up evaluations of breast cancer or multiple myeloma patients~     who received gene therapy (gene transfer) as part of their participation in an NIH protocol.~     Gene therapy is a new technology, which may involve a permanent change in the patient s~     genetic code. Therefore, although the risk of long-term harmful effects of this therapy is~     very small, the Food and Drug Administration requires prolonged monitoring of patients health~     status.~      Patients previously enrolled in NIH protocols 96-C-0007, 93-C-0208, 92-C-0161, or 92-H-0057~     will be followed under the current protocol. No further gene therapy will be provided in this~     study.~      Patients health status will be evaluated for an indefinite period of time, or as long as they~     are willing to be monitored. They will provide a blood sample once a year and will be~     interviewed about their health status twice a year for the first 5 years after gene therapy~     and once a year thereafter. These procedures are done to look for the development of any~     diseases such as cancer, neurological disorders, autoimmune or blood disorders that may be~     related to side effects of the gene transfer.~   "
238939|NCT00427713|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells~     that remain after surgery. It is not yet known whether giving capecitabine together with~     oxaliplatin is more effective than standard follow-up care in treating rectal cancer that was~     removed by surgery.~      PURPOSE: This randomized phase III trial is studying capecitabine and oxaliplatin to see how~     well they work compared with standard follow-up care in treating patients who have undergone~     surgery for locally advanced rectal cancer.~   "
238940|NCT00427700|"~     The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems.~     Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has~     a detrimental effect over uterine receptivity.~      Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental~     effect over the endometrium, and also increase the serum levels of FSH, thus, inducting~     ovulation.~      The objective of this study is to compare the ovulation rate in PCOS patients between~     clomiphene citrate and raloxifene in a double blind randomized trial.~   "
238941|NCT00427687|"~     This study will evaluate the effect of AGG-523 administration on biomarkers related to~     osteoarthritis. Safety and tolerability of AGG-523 will also be assessed.~   "
238942|NCT00427674|"~     The overall plan of this project is to evaluate [123I] mZINT as a tool to assess SERT density~     in humans. This protocol will be completed in three parts. In Part A serial dynamic SPECT~     will be acquired after injection of [123I] mZINT in healthy controls to assess regional brain~     uptake in human subjects. If Part A demonstrates robust brain region specific uptake, then~     Part B - additional studies in healthy subjects to assess biodistribution, and Part C -~     studies in PD subjects to compare regional uptake to healthy controls, will be completed.~   "
238943|NCT00427661|"~     Hypothesis 1: A novel nonmyeloablative condition regimen will be safe and efficacious in~     producing stable donor chimerism and cure of severe hemoglobinopathy.~      Hypothesis 2: Stable donor chimerism will result in amelioration of cerebral vasculopathy,~     improved cerebral perfusion and neurocognitive function.~      Specific Aim 1: Study the safety and efficacy of a novel non-toxic conditioning regimen for~     HSCT for patients with severe hemoglobinopathies and the kinetics of lineage specific~     chimerism after HSCT~      We will test our hypothesis that a novel nonmyeloablative condition regimen will be safe and~     efficacious in producing stable donor chimerism and cure of severe hemoglobinopathy:~      Specific Aim 2: Optimize the immunosuppressive regimen for HSCT patients through a thorough~     understanding of the pharmacokinetics of Busulfan (BU) and mycophenolate mofetil (MMF) in the~     patient population. This will involve:~        1. Determine the pharmacokinetics of intravenously and orally administered MMF and~          intravenous BU in patients receiving HSCT.~        2. Determine the relationship of Area under the curve (AUC) of BU and mean trough~          concentrations of mycophenolic acid (MPA) to engraftment and graft versus host disease~          (GVHD).~        3. Determine the relationship of Area under the curve (AUC) and steady state concentration~          of BU to engraftment at day 30 and 1 year post HSCT.~      Specific Aim 3: Study the effect of complete or partial donor chimerism on silent and overt~     cerebral vasculopathy, and neurocognitive functioning in patients with SCD undergoing HSCT.~     We will test our hypothesis that stable donor chimerism will result in improvement in~     cerebral vasculopathy and neurocognitive function. This will include.~        1. Determine effect of transplantation silent and overt cerebral vasculopathy by comparison~          MRA and TCD 1 year after HSCT to pre-HSCT studies.~        2. Determine effect on HSCT on neurocognitive function. Specific Aim 4: To determine the~          rate of T cell immune reconstitution in children with sickle cell disease following~          myeloablative compared to nonmyeloablative stem cell transplantation, using~          immunophenotyping assays, CDR3 spectratyping TREC analysis, and measurement of T cell~          specific donor engraftment.~   "
238944|NCT00427648|"~     The purpose of this study is to determine whether alkalized lidocaine instilled into the~     bladder is effective in the treatment of overactive bladder (OAB).~   "
238945|NCT00427635|"~     The purpose of this study is to assess the difference between esomeprazole and placebo in the~     treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring~     in neonatal patients.~   "
238946|NCT00427622|"~     RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using~     a skin conduction device or by using a diary.~      PURPOSE: This clinical trial is comparing a skin conduction device with a hot flash diary as~     a way of measuring hot flashes in postmenopausal women with hot flashes.~   "
238947|NCT00427609|"~     The purpose of this study is to determine the efficacy for Bicillin L-A, administered~     intramuscularly in a dose of 2.4 million units every three (3) weeks, for the treatment of~     chronic, plaque-type psoriasis unresponsive to topical medications or when other systemic~     therapies are contraindicated.~   "
238948|NCT00427596|"~     This is a two-part study. Part 1 is designed to find the best modified release formulation of~     GW423753; Part 2 is designed to use the selected formulation(s) from Part 1 to find out if~     food affects the way the medication is processed by the body.~   "
238949|NCT00427583|"~     This study assesses the safety and efficacy of imatinib mesylate treatment of patients with~     malignant peripheral nerve sheath tumors~   "
238954|NCT00427505|"~     This is a study to investigate the pharmacokinetics of deferasirox~   "
239710|NCT00417495|"~     The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast~     Cancer~   "
238956|NCT00427479|"~     An increasing number of people have an allergy to birch pollen, which manifests itself as~     Springtime hayfever. Some will also have cross-reactions to fruits, vegetables and nuts, a~     condition known as Oral Allergy Syndrome (OAS). Research has demonstrated that the most~     effective method of diagnosing this problem is by taking a good clinical history and~     performing skin prick tests using fresh foods.~      The aim of the study will be therefore to investigate the prevalence of OAS in a~     birch-sensitive population using a simple screening tool and establish the range of foods~     involved. The objective will be to maximise effective treatment for the patients in our large~     respiratory allergy clinic by using the screening tool to identify patients with OAS and~     advise them on the usual foods involved. A further objective will be to use the data to~     discover if there are any patterns of particular foods involved in OAS in UK sufferers.~      The study hypotheses are therefore that there is a high prevalence of oral allergy in people~     with birch pollen allergy; the best way of diagnosing the problem is by using a screening~     tool and that there is a core set of foods that are commonly involved in OAS in patients seen~     in the allergy clinic.~   "
238957|NCT00427466|"~     The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed in~     patients with metastatic soft tissue sarcoma who have progressed after or during an~     anthracycline-based chemotherapy and to assess the toxicity profile~   "
238958|NCT00427453|"~     This is a phase I study to test the immunogenicity of a recombinant vaccine based on Modified~     Vaccinia Ankara (MVA) expressing the antigen 85A (from Mycobacterium tuberculosis). This~     vaccine is delivered intradermally by a needle injection in healthy volunteers previously~     vaccinated with BCG.~   "
238959|NCT00427440|"~     The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the~     treatment of Advanced Malignant Glioma.~   "
238960|NCT00427427|"~     The purpose of the study is to determine what factors affect a patient's decision to accept~     delayed Herceptin® treatment after completing their surgery and/or chemotherapy and/or~     radiation therapy.~      Women with invasive breast cancer that have a HER-2 positive (FISH +) determination in 2004~     or thereafter and who have completed surgery and primary treatment earlier will be~     potentially eligible.~      Patients will be asked to complete a questionnaire about their breast cancer and reasons why~     they may or may not accept Herceptin® treatment. Patients will be given the option to (1)~     receive Herceptin® for 52 weeks and have annual doctor visits for 5 years or (2) not to~     receive Herceptin® but agree to annual doctor visits for 5 years.~   "
238961|NCT00427414|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~      PURPOSE: This clinical trial is studying how well liposomal daunorubicin works in treating~     patients with HIV-related Kaposi's sarcoma.~   "
238962|NCT00427401|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of PF-00915275 following administration to adult human subjects with~     T2DM for 4-weeks. The primary end point is glucose lowering (24 hour mean glucose~     concentration).~   "
238963|NCT00427388|"~     SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery~     requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse~     dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic~     inflammatory response that facilitates development of post-operative complications. SIRS will~     confirm or deny the potential clinical benefits of suppressing this response through the use~     of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given~     twice, once on anesthetic induction and again on CPB initiation, result in improved early~     survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?~   "
238964|NCT00427375|"~     Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5~     weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised~     in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the~     rate of patients with death, recurrence, major morbidity or severe after effects at two~     years.~   "
238965|NCT00427362|"~     To further assess the safety and effectiveness of adalimumab 40mg in the treatment PsA who~     have had an unsatisfactory response or intolerance to prior or ongoing DMARDs~   "
238966|NCT00427349|"~     RATIONALE: AMG 706 and octreotide may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well AMG 706 and octreotide work in treating~     patients with low-grade neuroendocrine tumors.~   "
238967|NCT00427336|"~     Primary Objectives:~        1. To determine the feasibility and toxicity of employing purine-analog based conditioning~          for allogeneic donor stem cell transplantation in patients with severe aplastic anemia~          (AA).~        2. To determine the engraftment kinetics and degree of chimerism that can be achieved with~          this strategy.~   "
238968|NCT00427323|"~     The purpose of this study is to test whether shifts in the timing of the biological clock to~     a later hour (phase delay shifts of the human circadian system) can be produced in response~     to four successive evenings of light exposure, and whether that phase shift will result in~     greater evening alertness and greater nighttime sleep efficiency. Three different light~     sources will be compared: 1) standard fluorescent light; 2) blue-enriched light; 3)~     incandescent fluorescent light.~   "
238969|NCT00427310|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing. It~     is not yet known whether giving fluorouracil into the liver is more effective than no further~     treatment for patients with colon cancer undergoing surgery.~      PURPOSE: This randomized phase III trial is studying giving infusions of fluorouracil into~     the liver in treating patients with Dukes' A, Dukes' B, or Dukes' C colon cancer undergoing~     surgery.~   "
238984|NCT00427115|"~     Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise -~     psycho-educational intervention in patients undergoing allogeneic stem cell transplantation~     (allo-HCST). The intervention included structured and supervised exercise, relaxation and~     psycho-educational components. It was hypothesized that the intervention would minimize loss~     of physical capacity during hospitalization.~   "
252420|NCT00247650|"~     This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acid are~     given before surgery to newly diagnosed post-menopausal women with early breast cancer~   "
238970|NCT00427297|"~     Globally, children who acquire HIV-1 increasingly do so in the context of maternal~     antiretroviral prophylaxis. It is important to determine whether maternal antiretroviral~     prophylaxis should alter infant treatment regimens. Nevirapine (NVP) is commonly used for~     PMTCT and is also a commonly used first-line drug for treatment of pediatric HIV-1.~     Approximately half of infants exposed to NVP have detectable NVP resistance early in infancy,~     with loss of detectable resistance over time. Thus, if an HIV-1 infected child was exposed to~     single-dose NVP prophylaxis, the question remains whether NVP or any NNRTI can be used~     effectively in therapeutic regimens. Alternative PI-based regimens are associated with~     heat-lability, poor palatability, cumulative toxicity, and fewer salvage options. This poses~     challenges for pediatric PI-based highly active antiretroviral therapy (HAART) in settings~     without refrigeration and limited antiretroviral repertoire. It is plausible that in older~     NVP-exposed infants (older than 6 months since exposure) who are genotypically~     NVP-susceptible, that nevirapine will be effective and useful.~      We propose to study resistance in a pediatric HIV-1 clinical trial involving 100 children.~     Among children enrolled at between 6 and 18 months of age, we will provide real-time~     field-based genotypic NVP-resistance testing, and randomize 100 NVP-susceptible children to~     NVP-containing versus NVP-sparing HAART to compare therapeutic response, adverse events, and~     morbidity in the 2 arms during 2-year follow-up. Follow-up in these studies will be closely~     monitored by an external Data Safety and Monitoring Board (DSMB).~   "
238971|NCT00427284|"~     The aim of the present study is to investigate wether endothelial dysfunction associated with~     stable coronary artery disease is altered by selective aldosterone antagonism with Eplerenone~     as potential anti-inflammatory drug versus placebo.~      Additionally we hypothesize that selective aldosterone antagonism reduces systemic~     inflammatory response such as C-reactive proteine, oxidative stress and pro-inflammatory~     cytokines.~   "
238972|NCT00427271|"~     Research design: randomized, double-blind, placebo-controlled crossover study to evaluate the~     putative interference of low-dose aspirin (for 8 weeks) on enalapril antiproteinuric~     properties in microalbuminuric type 2 diabetes mellitus patients~   "
238973|NCT00427258|"~     Absorption, distribution, metabolism, and excretion (ADME) study with 14C in healthy young~     men.~   "
238974|NCT00427245|"~     RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for~     breast cancer. It is not yet known whether goserelin is effective in preventing early~     menopause in women undergoing chemotherapy for breast cancer.~      PURPOSE: This randomized phase III trial is studying goserelin to see how well it works~     compared with no goserelin in preventing early menopause in premenopausal women undergoing~     chemotherapy for stage I, stage II, or stage III breast cancer.~   "
238975|NCT00427232|"~     Endothelin is a hormon that causes acute and chronic narrowing of heart vessels. The purpose~     of this study is to assess whether suppression of this activity by using two types of~     receptor antagonists can reduce this effect and thus improve blood supply of the heart~     muscle.~   "
238976|NCT00427219|"~     This study will compare the efficacy and safety of ozarelix 15 mg. given IM 2 weeks apart on~     the improvement of symptoms and the duration of improvement for up to 6 months in men with~     BPH who are over 50 years of age.~   "
238977|NCT00427206|"~     The study objective was to determine if liver injury develops in alcoholic patients during or~     following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two~     community detoxification centers to take either acetaminophen (4g/day) or placebo for 5~     consecutive days. All subjects were monitored an additional two days following the dosing~     period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4,~     6 and 7. We hypothesized that there would be no difference in aminotransferase means between~     the groups at any study period.~   "
238978|NCT00427193|"~     The purpose of this study is to test the hypothesis that two years of sustained 25% caloric~     restriction (CR) in men age 21-50 (inclusive) and women age 21-47 (inclusive) will slow aging~     and protect against age-related disease processes.~   "
238979|NCT00427180|"~     Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal~     Implant are able to differentiate between simple patterns like horizontal bar, vertical bar~     and cross.~   "
238980|NCT00427167|"~     This study will evaluate the safety and immune response of healthy volunteers to an~     experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909.~     Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that~     is spread by certain kinds of mosquitoes. Each year, about 1 million people are killed by~     malaria worldwide, most of them young children in Africa. AMA1 C1 may help block the malaria~     parasite from getting into red blood cells. The vaccine is mixed with Alhydrogel® (Registered~     Trademark), a material that is commonly added to vaccines to make them work better (also~     called an adjuvant). Besides evaluating the vaccine, this study will also test two solutions~     of an experimental adjuvant, CPG 7909-P and CPG 7909-S.~      Healthy people between 18 and 50 years of age may be eligible for this 7-month study.~     Participants are randomly assigned to one of four treatment groups (A, B, C or D below). All~     receive two vaccinations, given as a shot in the upper arm either 1 or 2 months apart, as~     shown:~        -  Group A: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 28~          (1-month interval)~        -  Group B: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 28~          (1-month interval)~        -  Group C: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 56~          (2-month interval)~        -  Group D: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 56~          (2-month interval)~      Group A and B participants return to the clinic for checkups at 3, 7, and 14 days after each~     vaccination and again at months 2, 3, 4, 5, and 7. Group C and D participants come to the~     clinic at 3, 7, and 14 days after each vaccination and again at months 3, 4, 5, and 7.~      In addition to the vaccinations, the study includes the following procedures:~        -  Photographs of the subject's arm where the vaccination is given if a rash develops.~        -  Daily temperature and symptoms record for the first 6 days after each of the 2~          vaccinations, and at any other time there is concern about fever or other symptoms.~        -  Blood draws about 12 times during the study to check for safety and to measure the~          antibody response and the effect of the study vaccine.~      Some participants may be asked to undergo plasmapheresis, a procedure for collecting plasma,~     the liquid part of the blood. This is done by using a machine called a blood cell separator.~     Blood is collected through a needle place...~   "
238981|NCT00427154|"~     This trial is conducted in the United States of America (USA). This trial will compare the~     changes in HbA1c after 26 weeks of inhaled insulin or rosiglitazone treatment, both in~     combination with metformin and glimepiride.~   "
238982|NCT00427141|"~     Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in~     animals affected the digestive system and blood cells. Study OPS106400 will be the first~     administration of GSK580416 in humans. Parts A and B of this study will examine the safety,~     tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to~     placebo. Part C of the study will assess the effect of food on the safety, tolerability, and~     pharmacokinetics of a single dose of GSK580416 in healthy subjects.~   "
239008|NCT00426803|"~     This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study~     is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute~     intracerebral bleeding.~   "
238985|NCT00427102|"~     Rationale for Study~      Oral mucositis is a major complication arising from contemporary chemoradiation treatment of~     patients with head and neck cancer.~      No effective therapy exists to prevent this complication in this population. MRX-1024 is an~     investigational agent that has demonstrated in in vitro and in vivo experiments to have the~     potential to exert a protective effect in normal mucosa cells, without interfering with the~     intended antitumor effect of radiation.~      A pilot Phase 1 study of MRX-1024 was conducted in India in patients with head and neck~     cancer receiving radiation alone or radiation in combination with cisplatin or carboplatin.~     MRX 1024 doses of 100 mgkg given orally twice a day, five days a week during radiation~     treatment cycles, were well tolerated and appeared to exert a protective effect against the~     development of severe mucositis.~      Twice daily doses of MRX 1024 impose a certain level of inconvenience to the patient, to~     their clinic companion, and to the general work flow within radiation oncology clinics.~      This study is designed to study the safety and pharmacokinetics of both single daily dose and~     twice daily dose regimens of oral MRX 1024 given in conjunction with daily radiation~     fractions and intermittent high-dose cisplatin to patients with high-risk for recurrence head~     and neck cancer following surgical resection. The study will also document the incidence and~     severity of oral mucositis that occurs following such therapy. The results will be~     instrumental in determining the regimen of MRX 1024 to use in subsequent definitive clinical~     trials.~   "
238986|NCT00427089|"~     To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution~     (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening~     colonoscopies~   "
238987|NCT00427076|"~     Methicillin-resistant Staphylococcus aureus (SA) is a major pathogen causing mainly~     health-care associated infections and, lately, also community acquired infections. Few~     treatment choices exist to treat these infections. The currently recommended antibiotics for~     these infections are glycopeptides (vancomycin or teicoplanin). Glycopeptide treatment hs~     several disadvantages. It is a last resort antibiotic family that should be reserved for the~     future; Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to~     both agents; treatment can only be given intravenously; and use of vancomycin has led to the~     development of SA strains with partial or complete resistance to vancomycin. Cotrimoxazole is~     an old antibiotic active against most strains of MRSA, depending on local epidemiology.~      Study hypothesis: The purpose of this study is to show that cotrimoxazole is as effective as~     treatment with vancomycin for invasive MRSA infections.~      We plan a randomized controlled trial comparing treatment with cotrimoxazole vs. vancomycin~     for invasive MRSA infections. The primary efficacy outcome we will assess will be Improvement~     or cure with or without antibiotic modifications, defined as: survival at 7 days post~     randomization with resolution of fever (<38 for two consecutive days) and resolution of~     hypotension (>90 systolic without need for vasopressor support); and physician's assessment~     that the primary infection was improved or cured. The primary safety outcome will be~     all-cause 30-day survival.~   "
238988|NCT00427063|"~     The purpose of this study is to asses the relative influence of genetic and environmental~     influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged~     20-46 years. We expect to find a high heredity for the variation in tortuosity. This~     knowledge can contribute to the elucidation of the pathology in retinal diseases.~   "
238989|NCT00427050|"~     The purpose of this study is to determine the optimal tolerated regime of PEP005 for the~     treatment of actinic keratoses of the face or face and scalp.~   "
238990|NCT00427037|"~     This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of~     the subjects will be randomized to vitamin D3 and the other half will receive a placebo.~     Subjects will be referred from the nutrition or renal clinic at Emory. CKD stage 3 and 4~     patients will be eligible for participation if they have been determined to have vitamin D~     deficiency and are not on treatment with vitamin D or vitamin D analogues. Subjects will sign~     an informed consent form after reviewing the protocol in detail with the principal~     investigator. A questionnaire would collect information about dietary vitamin D intake,~     sunlight exposure, and any symptoms of vitamin D deficiency. The subject will have baseline~     levels of serum vitamin D (25-hydroxyvitamin D), parathyroid hormone (PTH), serum calcium and~     phosphate, creatinine and other markers of bone turnover. The questionnaires and the blood~     draws would be repeated on the 6th and 12th week of the study. Subjects will be given 12~     pills of each containing either 50,000 IU vitamin D or placebo and asked to take one pill a~     week. They would be scheduled to return to the clinic after 6 weeks and blood measurements~     would be repeated. Subjects will be asked to revisit for their final visit at the 12th week~     when they would have their last blood draw and assessment.~   "
238991|NCT00427024|"~     Previous studies in animals revealed, that the activity of certain transporters along the~     nephron is changed with acute rejection after renal transplantation. We intend to investigate~     underlying mechanisms occurring in man in renal biopsy specimens obtained from patients~     because of acute rejection of the transplant or chronic transplant nephropathy.~   "
238992|NCT00427011|"~     Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will~     receive active study drug. The study will involve outpatient visits only. Patients who~     completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria~     will be enrolled and enter the 12-week Titration Phase (from Dispense Study Drug at Week 0~     [Visit 2] through Week 12 [Visit 7]) followed by the Maintenance Phase (from Week 12 [Visit~     7] to end of study).~   "
238993|NCT00426998|"~     The purpose of this research study is to compare different timing therapies of Verteporfin~     with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular~     degeneration (AMD).~   "
238994|NCT00426985|"~     The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain~     associated with tendonitis or bursitis of the shoulder, elbow or knee~   "
238995|NCT00426972|"~     This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness~     skin graft donor sites in patients aged 18-85 years.~   "
239034|NCT00426452|"~     This study will determine the effect of acidic drugs such as proton-pump inhibitors on the~     pharmacokinetics of Vatalinib under fasting and fed conditions.~   "
239924|NCT00414635|"~     For people with HIV who are currently taking specific medications (including Sustiva~     (efavirenz)) and have no detectable viral load, this study tracks how patients do if they~     take their medications for five days of the week compared with seven days of the week.~   "
238996|NCT00426959|"~     This will be a phase I study. This phase I study is not a standard drug dose escalation~     study, but rather a Clinical System Performance Evaluation Trial of a therapeutic device.~     However for purposes of this protocol we will refer to this portion of the trial as a phase I~     study.~      The purpose of this study is to demonstrate the feasibility and clinical practicability of~     the registered ultrasound and fluoroscopy (RUF) in combination with CMS Interplant system® in~     an initial cohort of 6 patients.~      This will involve demonstrating the feasibility of using the system in an actual operating~     room environment as well as obtaining a preliminary assessment of the accuracy and~     performance of the source location algorithm by comparing with postoperative CT dosimetry.~      The Primary endpoint of this study will be evaluation of the feasibility of using the RUF~     system and of performing real-time optimization in the operating room environment.~      The Secondary endpoints of this study will be:~        1. Acute and late toxicity as assessed by IPSS, SHIM, and EPIC questionnaires at multiple~          follow-up intervals.~        2. PSA-free survival.~      Study Population:~      The target population will be patients with a diagnosis of adenocarcinoma of the prostate who~     are seen in consultation at the Johns Hopkins Hospital.~      Approximately 360 patients per year with the diagnosis of prostate cancer are seen in the~     Department of Radiation Oncology at Johns Hopkins Hospital. Of these patients, approximately~     45% have low-risk (T1a-T2a, Gleason 6 or less, PSA 10 ng/ml or less) or intermediate-risk~     disease and are suitable for brachytherapy based on disease risk. Within this group of~     patients, approximately 70% are eligible for brachytherapy based on gland size and no prior~     transurethral resection of prostate (TURP).~      Approximately 80% of patients offered brachytherapy at consultation decide to receive their~     treatment at Johns Hopkins. Overall, we currently perform 2 brachytherapy procedures per week~     on average, for a yearly total of approximately 90 cases.~      For purposes of homogeneity of treatment and patient population, this protocol will only~     enroll patients currently treated at this institution with brachytherapy alone, and will not~     enroll patients (intermediate or high risk disease) who will require external beam radiation~     in addition to brachytherapy.~   "
238997|NCT00426946|"~     The aim of the present study is to prospectively assess the anti-depressant effectiveness of~     reboxetine in children and adolescents, as compared with fluoxetine, in a randomized~     controlled open-label trial.~   "
238998|NCT00426933|"~     multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of~     HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for~     7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized~     on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g.~     q12h for up to 14 days.~   "
238999|NCT00426920|"~     Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried~     recombinant human insulin powder for inhalation administered via a dry powder uinhalation~     device compared with subcutaneously administered regular human insulin in healthy male~     volunteers under the conditions of a eugycemic clamp.~   "
239000|NCT00426907|"~     In this project we want investigate the clinical results after different rehabilitation~     regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial~     Osteotomies.~      The hypothesis is that unlimited weightbearing is beneficial for the healing and~     rehabilitation.~   "
239001|NCT00426894|"~     the purpose of this study is to determine whether children who are hospitalised waiting for~     cardiac surgery for several days in pediatric or pediatric surgery department acquire~     resistant microbial flora, thus necessitating broad spectrum antibiotics for perioperative~     prophylaxis.~   "
239002|NCT00426881|"~     Primary Objectives:~      1. To ascertain whether a 12-month, twice-weekly or once-weekly resistance training (RT)~     program will significantly improve executive function in community-dwelling women aged 65 to~     75 years old compared with a 12-month, twice-weekly stretch and relax (S & R) program (shame~     exercise). We will assess executive function by standard neuropsychological tests.~      Secondary Objectives:~        1. To describe the neural mechanisms that underpin the observed changes in executive~          function associated with a 12-month, twice-weekly or once-weekly RT training (by using~          functional magnetic resonance imaging (fMRI)).~        2. To investigate whether RT-induced changes in executive function are independently~          associated with changes in physiological fall risk profile.~        3. To investigate the dose response of RT (resistance training) on bone health as measured~          by dual energy x-ray and peripheral quantitative computed tomography.~        4. To conduct a one-year follow-up after the formal cessation of the resistance training~          programs to determine the persisting effect of resistance training on cognitive~          performance, cortical plasticity, physiological falls risk, and bone health.~   "
239003|NCT00426868|"~     The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived~     Stem & Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not~     revascularizable and have demonstrated reversible ischemia.~   "
239004|NCT00426855|"~     The purpose of this study is to determine whether the combination of bendamustine and~     bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia~     is safe and tolerable.~   "
239005|NCT00426842|"~     With upright postures, there is an immediate redistribution of blood to the dependent~     circulation; venous return and central venous filling pressure are reduced, resulting in~     diminution of cardiac output and blood pressure. These hemodynamic alterations stimulate the~     baroreceptor reflex, which is mediated via the central nervous system to increase peripheral~     sympathetic vasomotor tone, restoring blood pressure and cardiac output within~     seconds-to-minutes of the assumption of the upright position. Following SCI, individuals~     often experience the inability to adjust to postural changes due to disruption of central~     command of the baroreceptor reflex and reduction in efferent sympathetic neural pathways;~     consequently, orthostatic hypotension (OH) and symptoms of cerebral hypo-perfusion may ensue.~     OH is a well-documented phenomenon, which is characterized by a fall in systolic blood~     pressure of >20 mmHg or diastolic BP of > 10 mmHg within 3 minutes of assumption of an~     upright posture. As a consequence of OH, many individuals experience symptoms of cerebral~     hypo-perfusion which include lightheadedness, dizziness, blurry vision, fatigue, nausea,~     ringing in the ears, cognitive impairment and heart palpitations. Although several~     investigators have reported increased prevalence of OH during the acute phase of spinal cord~     injury (SCI), individuals with chronic injury also experience significant falls in blood~     pressure with seated upright postures. This investigation will examine the effects of an~     alpha-agonist, midodrine hydrochloride, during head-up tilt on systemic blood pressure,~     cerebral blood flow and cerebral oxygenation compared to placebo administration in persons~     with chronic SCI who demonstrate significant orthostatic hypotension during a 24-hour~     observation study. This is the first study to determine the dose response and efficacy of~     midodrine to improve orthostatic blood pressure and cerebral blood flow and oxygenation in~     the SCI population.~   "
239006|NCT00426829|"~     Primary Objectives:~        1. To evaluate the safety of the treatment of patients with technically or medically~          inoperable hepatocellular carcinoma and cholangiocarcinoma with proton therapy and~          concurrent bevacizumab biotherapy.~        2. To identify the maximum tolerated dose (MTD) using this combination.~      Secondary Objectives:~        1. To evaluate local control rate within the radiation field, hepatic control rate outside~          the treatment field, time to radiographic progression and 2 year survival rate.~        2. To analyze dose-volume characteristics that influence the development of radiation~          induced liver disease (RILD) and GI bleeds that may occur.~        3. To assess quality of life during and after chemoradiation therapy.~   "
239007|NCT00426816|"~     This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity,~     PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects~     with primary insomnia~   "
239009|NCT00426790|"~     The hypothesis of this study is that the Open lung approach ( recruitment and PEEP) during~     general anaesthesia reduces atelectasis formation and improves respiratory function in the~     immediate post-operative period after major abdominal surgery.~      This is a prospective, randomized, controlled clinical-trial,performed in patients undergoing~     major abdominal surgery, to compare the effects on the post-operative pulmonary complications~     of two different intraoperative ventilatory strategies during general anaesthesia: 1- Control~     Group: PEEP 0 cmH2O without recruitment manoeuvre; 2- Treatment Group:recruitment manoeuvre~     (after intubation and before extubation) and PEEP 10 cmH2O In the post-operative period the~     following variables will be recorded at the first, third and fifth postoperative day: 1-~     Gas-exchange in air; 2- Chest X-ray for atelectasis evaluation; 3- signs of pulmonary~     complication (cough, secretions, dyspnea, thoracic pain)~   "
239010|NCT00426777|"~     Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral~     density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent~     osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer~     patients treated with LHRH agonists.~   "
239011|NCT00426764|"~     The purpose of this study is to evaluate the activity of romidepsin in patients with~     progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with~     systemic therapy.~   "
239012|NCT00426751|"~     Multinational, multicentre, randomised, prospective, open, parallel group study directly~     comparing two glycoprotein-IIb/IIIa inhibitors, abciximab and eptifibatide, added early to~     standard treatment before primary PCI of STEMI patients with respect to effect on~     sum-ST-resolution after 60 minutes post-procedure and other measures of myocardial~     reperfusion~   "
239013|NCT00426725|"~     The suggested research is aimed to test the effectiveness of an external mechanical device to~     be applied and used by the parturient herself in pain relieving during labour . The research~     is to be performed in a controlled closely observed way, to ensure the safety of the involved~     parturient and newborn.~   "
239014|NCT00426712|"~     The purpose of this study is to find out if a new investigational hepatitis B virus vaccine,~     HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney~     function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and~     are expected to eventually go on hemodialysis.~   "
239015|NCT00426699|"~     Enteroviruses can infect most human organ systems, especially the heart, nervous system and~     pancreas. Whether Enteroviruses can also affect the kidneys is not known yet. Therefore we~     will analyze urine of children with a suspected enteroviral infection for enteroviruses and~     signs of kidney infection.~   "
239016|NCT00426686|"~     Thrombotic thrombocytopenic purpura (TTP) is a thrombotic microangiopathy defined by the~     spontaneous formation of platelet thrombi in the microvessels. These platelet microthrombi~     are responsible for a mechanical hemolytic anemia, a thrombocytopenia and a multivisceral~     ischemia. TTP is a rare but life-threatening disease in the absence of appropriate treatment~     (PLASMATHERAPY). The onset of the disease usually occurs in adulthood (MOSCHCOVITZ syndrome)~     and rarely in childhood (UPSHAW-SCHULMAN syndrome). TTP is either sporadic or recurrent with~     multiple unpredictable relapses. TTP pathophysiology has remained obscure until a new~     metalloprotease, ADAMTS13, has been demonstrated to be involved in about 90% of all cases.~     Physiologically, ADAMTS13 function consists in limiting the size of von Willebrand factor~     (VWF) multimers and consequently, their hemostatic capacity. A large majority of TTP is~     associated with a severe deficiency of ADAMTS13. In most cases, ADAMTS13 severe deficiency is~     acquired via auto-antibodies to ADAMTS13; more rarely, ADAMTS13 deficiency is hereditary via~     ADAMTS13 gene mutations. ADAMTS13 auto-antibodies are either inhibitory of the catalytic~     activity or non inhibitory. ADAMTS13 mutations are spread all over the gene.~      TTP prognosis is quite heterogeneous. Indeed, in about one third of the patients, TTP is~     refractory to PLASMATHERAPY and/or chronic relapsing. Until now, TTP prognosis factors are~     not known. Their identification is however crucial both to adapt the curative treatment of an~     acute episode (addition of first intention immunosuppressive agents to PLASMATHERAPY) and to~     prevent relapses.~      In this context, the aim of the current project is to identify some ADAMTS13 related~     prognosis factors in TTP. A national prospective multicenter study including both adult and~     pediatric patients with TTP related to a severe ADAMTS13 deficiency will be designed over a~     three-year period. This study will involve our group as the French reference center for~     ADAMTS13 and 10 clinical departments from various French hospitals. Patients will be tested~     for ADAMTS13 activity and antigen, ADAMTS13 antibodies and ADAMTS13 gene sequencing. Our main~     hypothesis is that the inactivation of the ADAMTS13 domains crucial for its catalytic~     activity, either by inhibitory auto-antibodies (acquired TTP) or by genetic mutations~     (hereditary TTP) is a major bad prognosis factor.~   "
239017|NCT00426673|"~     The primary objective of this Phase I study in 15 adult subjects suffering from epilepsy and~     chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb~     34714 administration on the steady-state plasma levels of phenytoin.~   "
239018|NCT00426660|"~     To provide access to maraviroc to patients who have limited or no therapeutic treatment~     options and to collect more safety data in a broader patient population.~   "
239019|NCT00426647|"~     The primary objective of this equivalence study is to evaluate the efficacy of Norspan®~     patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of~     the hip, knee and/or lumbar spine.~      The secondary objectives are to evaluate the safety and general satisfaction for the patients~     in the two treatment groups.~   "
239020|NCT00426634|"~     This study will examine whether exposure to the increased levels of mold and other allergens~     in New Orleans post-Hurricane Katrina affect symptoms in children with asthma. It will also~     determine if having an asthma counselor (AC) can reduce a child s asthma symptoms in this~     setting. An AC helps the families in the study obtain appropriate health care, medicines and~     social services for their asthmatic child and instructs them about avoiding allergens and~     ridding allergens from the home.~      Children between 4 and 12 years of age living in Orleans Parish or surrounding areas impacted~     by flooding who have moderate to severe asthma may be eligible for this study.~      Parents provide a family medical history and information about the child s asthma symptoms,~     medications and medical history. The children undergo the following procedures:~        -  Medical examination and blood tests~        -  Spirometry (for children 6 and older) or peak flow (for children under 6) test: For~          spirometry, the child wears a nose clip and breathes into a mouthpiece attached to a~          machine that measures how fast air moves out of the child s lungs. For the peak flow~          meter test, the child blows into a plastic tube after taking a deep breath.~        -  Allergy skin testing: 24 common allergens are applied to the arm by little pricks or~          scratches and the skin is observed for reactions to the allergens.~      Study staff visit the participants homes three times during the 1-year study to test for~     moisture, mold and other allergens. After the first visit, families are randomly assigned to~     one of two groups. Group 1 participants attend two educational group sessions about asthma~     and then three individual sessions. An AC visits the home one time during the study to~     instruct the family on how to use supplies provided to reduce allergens in the home. Group 2~     participants have an individual special teaching meeting with the AC at the end of the study.~     After the meeting, the AC visits the home to instruct the family on use of the supplies.~      Families are surveyed by phone every 3 months during the study to answer questions about the~     child s asthma attacks, medicines used, doctor visits, school days, missed, or work days~     missed to care for the child. At the end of the study, the child has a final medical~     examination, blood test, and breathing test.~   "
239021|NCT00426621|"~     This study will test the efficacy and safety of topical diclofenac sodium gel in the~     treatment of knee osteoarthritis.~   "
239022|NCT00426608|"~     A study to investigate the effects GSK561679 on part of the body's system that controls the~     balance of many of the hormones (including cortisol).~   "
239023|NCT00426595|"~     Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most~     children with cerebral palsy and mental retardation. Oral administration of enteric-coated~     formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in~     these patients who may be suffering from swallowing disorders. A suspension of omeprazole in~     a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This~     trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy~     tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus~     the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The~     crossover study will consist of 2 consecutive treatment periods of 14 days.~   "
239024|NCT00426582|"~     This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of~     patupilone combined with carboplatin in adult patients with advanced solid tumors who~     progressed despite standard therapy or for whom no standard therapy exists or who might~     benefit from treatment with carboplatin~   "
239025|NCT00426569|"~     The purpose of this study is to check if bacterial and fungal flora exists in healthy~     paranasal sinuses, and whether it is identical to the flora of nasal cavity.~      We plan to harvest tiny examples of maxillary sinus and nasal mucosa for tissue cultures~     during the orthognathic procedures involving maxillary remodeling.~   "
239026|NCT00426556|"~     Phase I: will look at different dose levels and regimens of everolimus combined with weekly~     trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast~     cancer.~      Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined~     with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing~     metastatic breast cancer.~   "
239027|NCT00426543|"~     The primary purpose of the study is to determine whether B-cell depletion with Rituximab has~     an effect on the oral, ocular and general disease manifestations in patients with primary~     Sjögren´s syndrome, that is, an effect on the symptoms of oral and ocular dryness,~     improvement of the glandular function and a beneficial effect on the general symptoms such as~     fatigue. The secondary purpose of the study is the investigate the underlying autoimmune and~     pathophysiological mechanisms in Sjögren´s syndrome.~   "
239028|NCT00426530|"~     This study will look at different dose levels and regimens of everolimus combined with weekly~     trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast~     cancer.~   "
239029|NCT00426517|"~     This study uses transplantation to treat patients with problems in their immune system. The~     immune system cells come from the bone marrow where they grow from special cells called stem~     cells. Giving patients stem cells from someone else may help to cure many patients with~     certain immune diseases. This is called 'bone marrow transplantation'. This procedure can~     have side effects that are life-threatening. To try to make transplantation safer we are~     using lower doses of the medications used in preparing the patient for the transplant.~      'Conditioning' treatments are given to patients to create space in their bone marrow. This~     lets the cells of the donor go into the bone marrow and produce normal immune cells. This~     study will use lower doses of a drug called busulfan and lower doses of radiation than what~     are currently being used in other kinds of bone marrow transplantation for other diseases.~      Another problem that can occur with bone marrow transplantation is 'graft-versus-host~     disease'. This happens when the cells of the donor attacks different parts of the patient s~     body. This study will use a medicine called sirolimus instead of the usual medicine,~     cyclosporine, to prevent graft-versus-host disease.~      To go onto this study, you must have:~        1. A severe immune deficiency, such as chronic granulomatous disease or leukocyte adhesion~          deficiency.~        2. Have problems from the disease that call for stem cell transplantation.~        3. You must also be between the ages of 2 and 40 years.~      Two groups of patients are included in this study:~        1. Patients who have a brother or sister that have stem cells that match the patient. This~          is known as an allogeneic matched sibling transplant.~        2. Patients who do not have a matched sibling donor but have a donor that matches in the~          National Marrow Donor Program. This is know as matched unrelated donor transplantation.~      Patients will have the following procedures:~        -  To create space in the bone marrow, patients are given two drugs, Campath-1H and~          busulfan. To prevent the body from getting rid of the donated cells, patients are given~          sirolimus. On the day before the BMT, patients in the matched unrelated donor group also~          receive a low-dose of whole-body radiation. This will further improve the chances that~          the patients body will accept the donor cells.~        -  Patients will get the donor stem cells through an intravenous (IV) line that goes into a~          vein in their body. The cells make their way to the bone marrow space and slowly refill~          the marrow over the next several weeks. Patients will usually stay in the hospital for~          30 days after the transplant.~        -  For the first 3 months after the transplant, patients are watched closely. The patients~          will have frequent visits to the clinic. During these visits the patient will have a~          physical examination and blood tests. The doctor and nurse will also check any symptoms~          the patient may have. At day 100 after the transplant a sample of bone marrow is taken.~        -  Patients will continue to be followed periodically for at least 5 years after the~          transplant.~   "
239030|NCT00426504|"~     Historically, patients with stage III and IV head and neck cancer have been treated with~     surgery and/or radiation therapy. Based on the results of recent clinical trials, in patients~     not able to undergo surgery, chemotherapy with radiation therapy has been adopted as the~     current standard of care. The chemo-radiation approach, however, entails a significant~     increase in treatment-related toxicity, limiting the extent to which this treatment can be~     offered to patients. In this trial, the ability of a new form of radiation therapy delivery~     called IMRT will be evaluated for its ability to reduce the amount of radiation-induced~     toxicity.~   "
239031|NCT00426491|"~     The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle~     and Co., Chicago, IL) for the management of non-viable first trimester pregnancies.~     Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant~     management in who have documented non-viable gestations. We will examine the following~     outcome variables: time to resolution, number of patients requiring dilation and curettage,~     change in hematocrit, cost to the institution, patient satisfaction, and reported side~     effects.~   "
239032|NCT00426478|"~     A double-blind, active-controlled, randomized trial to compare Valsartan plus~     Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5 mg.~      Study design: 2 weeks washout, 8 weeks treatment period.~   "
239033|NCT00426465|"~     This study will explore the optimum training schedule for stroke patients to learn motor~     skills. It will see if motor training is more effective when training sessions are~     distributed over time (spaced training) or when the sessions are scheduled close together~     (massed training). The results of this study may help researchers devise the best training~     schedule for patients to derive the maximum benefit from rehabilitation therapy.~      Healthy normal volunteers and people who have had a stroke may be eligible for this study.~     Patients must be 3 months post-stroke. All participants must be right-handed and between 18~     and 80 years of age.~      Participants practice a pinch motor task and receive transcranial magnetic stimulation (TMS).~     Hand muscle activity is measured using surface electromyography (EMG). Pinch training~     involves training the participant to pinch as strongly as possible, using a device that~     records the force. For TMS, a wire coil is held on the subject s scalp. A brief electrical~     current is passed through the coil, creating a magnetic pulse that stimulates the brain. The~     subject hears a click and may feel a pulling sensation on the skin under the coil. There may~     be a twitch in the muscles of the face, arm or leg. For surface EMG, electrodes (small metal~     disks) are filled with a conductive gel and taped to the skin over the muscle.~      Following one practice session of pinch task training and TMS, participants have four~     training sessions, which are scheduled 24 hours, 2 weeks, 1 month and 3 months after the~     practice session.~      For the 4- to 5-hour practice session, subjects do the following:~        -  Perform a single session of pinch motor task for familiarization~        -  Undergo TMS to measure brain activity~        -  Practice five 6-minute blocks of pinch motor task with rest periods between sessions and~          perform a calculation task (addition and subtraction tasks) during each rest period~        -  Receive TMS over 15 minutes. (Some sessions may have sham TMS.)~        -  Read books and magazines during a 45-minute rest period~        -  Perform a single block of the pinch motor task~        -  Undergo TMS to measure brain activity~        -  Complete a questionnaire that measures attention, fatigue and mood~      For the remaining four sessions, participants perform one practice block and TMS. Each~     session lasts about 2 hours.~   "
239035|NCT00426439|"~     This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared~     to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in Guinea-Bissau.~     The genetic basis of the parasites for developing resistance will be examined. Children~     coming to one of the Health Centres with symptoms of malaria and a positive malaria test will~     be included. The children will be followed weekly until day 70. In case of reappearance of~     parasites the child will be re-treated with the opposite study drug.~   "
239036|NCT00426426|"~     Meta Cognitive Therapy (MCT) has been introduced as a new specific treatment for generalised~     anxiety disorder. So far, no studies have examined CBT and MCT in comparison with each other~     in a randomised controlled trial. Sixty patients with a diagnosis of generalised anxiety~     disorder will be selected and randomised into three treatment conditions. The first group~     (N=20) will be treated with CBT, the second group (N=20) with MCT, and the third condition is~     a waiting list control (N=20). The patients in both groups will have full treatment, in~     accordance to treatment manuals developed by the originators. Patients in the waiting list~     control will be randomly allocated to either CBT or MCT after 12 weeks of waiting period.~      The patients will be assessed with the primary measures at pre-treatment, at the end of~     treatment, and at follow-up after one and two years. In addition they will be assessed weekly~     on symptom measures and worry outcome diary. The therapist will be treating equally amount of~     patients in both conditions to control for any biased distribution connected to the~     therapist's characteristics.~      Measures will be used on at least three main sources; self-report inventories (including~     symptom diaries), clinical assessments by independent raters and psycho-physiological~     assessments.~      We aim to (1) evaluate and compare the effectiveness of CBT and MCT, (2) investigate the~     patterns of change and the mechanisms of action involved during treatment in each of the~     conditions and, (3) evaluate pre and post-treatment somatic change by psycho-physiological~     assessments as a response to CBT and MCT.~   "
239037|NCT00426413|"~     Over 50% of obese African-Americans (AA) presenting with newly diagnosed, severe~     hyperglycemia and/or unprovoked diabetic ketoacidosis (DKA) display clinical, metabolic, and~     immunogenetic features of type 2 diabetes. Prior studies indicate that these patients a) have~     markedly decreased insulin secretion and impaired insulin action at presentation, b) absent~     or low prevalence of beta-cell autoantibodies and c) are able to discontinue aggressive~     insulin therapy in ~70% of cases within 3 months of follow-up. These patients have been~     referred to as having ketosis-prone type 2 diabetes (KPDM). Most patients with KPDM, however,~     experience a hyperglycemic relapse within a year of insulin discontinuation. Consequently,~     patients with KPDM are an ideal model to follow throughout their clinical course. The~     specific aims of this proposal are to 1) identify clinical, metabolic, and immunogenetic~     markers that alone, or in combination, are predictive of short- and long-term~     near-normoglycemic remission and 2) determine whether pioglitazone or sitagliptin therapy~     will delay an insulin-deficient relapse once insulin is discontinued. The Principal~     Investigator hypothesizes that measures of beta-cell function at presentation, alone or in~     combination with measures of insulin sensitivity, will correlate with the ability of a~     patient to achieve and remain in near-normoglycemic remission. She also hypothesizes that~     intervention compared to placebo will preserve beta-cell function, improve insulin~     sensitivity, and prevent an insulin-deficient relapse. This prospective, cohort study with a~     RCT arm would better characterize the natural history of KPDM, facilitate the direction of~     long-term therapy, and likely decrease the recurrence of DKA which is associated with~     increased mortality and morbidity.~   "
239038|NCT00426400|"~     Our study investigates the effect of anti-aggregative treatment on success and complications~     of laser iridectomy. The study includes patients scheduled for laser iridectomy due to narrow~     angles.Patients will undergo first laser treatment with the anti-aggregative treatment and~     will scheduled for next lase in the other eye after discontinuing the anti-aggregative~     treatment. The patients will be followed-up for 3 months.~   "
239039|NCT00426374|"~     The purpose of this study is to perform cardiac evaluation in HIV-1 (predominantly clade~     C)infected children by history, physical examination, echocardiogram and plasma N-terminal~     pro-B-type natriuretic peptide (N-BNP)measurement in order to determine asymptomatic~     abnormalities.~   "
239040|NCT00426361|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and~     thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical~     cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents~     platform. Therefore, this Phase IIIb study is designed to evaluate the safety and~     immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals'~     (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either~     vaccine alone.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
239041|NCT00426348|"~     a statement of the study hypothesis:the effect of valsartan in patients with IgA nephropathy~     have been proved,and the efficacy of probucol in combination with valsartan is to be proved~     in patients with IgA nephropathy.~      This is a prospective randomized controlled, double blinded pilot study to identify the~     efficacy of probucol in combination with valsartan in patients with IgA nephropathy. The~     renal function deterioration will be the primary outcome studied. The expected study duration~     will be 36 months.~   "
239042|NCT00426335|"~     The purpose of this study is to examine whether a group CBT intervention is effective in~     reducing psychological distress in women with primary breast cancer.~   "
239043|NCT00426322|"~     The aim of this clinical study is to compare the amount of newly formed bone after bone~     augmentation with Bio-Oss® (BO) 0.25-1 mm vs. Bio-Oss® (BO) 1-2 mm in the sinus floor~     augmentation procedure bilaterally in 8 patients.~      Hypothesis:~      There is no difference in the relative amount of newly formed bone plus BO between the large~     (1-2 mm) and small (0.25 - 1 mm) granules.~   "
239044|NCT00426296|"~     SHARE: Simple HAART with Abacavir, Reyataz, and Epivir~   "
239045|NCT00426283|"~     The purpose of this study is to test the effects (both good and bad) of swallowed fluticasone~     propionate (Flovent), in subjects with eosinophilic esophagitis (EE).~   "
239061|NCT00426062|"~     Study comparing level of free radicals in tumor tissue, blood serum and saliva in patients~     with Squamous Cell Carcinoma of tongue and mouth floor. Patients with benign fibroma of oral~     cavity and normal gingiva around extracted lower wisdom tooth are used for control~   "
239046|NCT00426270|"~     Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for~     intravenous administration. Octagam 5% is currently registered in about 80 countries. This~     study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura~     (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that~     Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.~   "
239047|NCT00426257|"~     This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal~     chemotherapy to secondary debulking surgery in stage III ovarian cancer.~   "
239048|NCT00426244|"~     The purpose of this study is to determine to what extent and by what physiological mechanisms~     Osteopathic Manipulative Medicine (OMM) affects selected conditions related to pregnancy,~     labor and delivery.~   "
239049|NCT00426231|"~     Our research aims to improve the use of medicines known to prevent recurrent heart attacks.~     In particular, we know that statin treatment is useful after heart attacks, but many patients~     do not use it. There are a few possible reasons for this. Patients cannot find affordable~     medicine. Their doctor may not prescribe the medicine after they leave the hospital. Some~     people may culturally mistrust using the medicine. So they may decide not to take it even if~     it is prescribed. We are developing a hospital based culturally attuned program to target~     this problem. In this program, a community health worker counsels and helps patients in~     accessing pharmacy assistance programs. We will test whether this program can improve~     appropriate statin use.~      We will enroll patients who have heart attacks. We will compare patients who are counseled by~     the community health worker with those who get the usual care at baseline and at 6 and 12~     months (participants enrolled during the early phase of the recruitment will have an~     additional study visit at 24 months). We will test if their bad cholesterol levels are~     controlled. We will find out how regularly they have filled their questionnaire and taken the~     medicine. Finally, we will test if they are getting benefit from the statin treatment. We~     will do this using blood tests and imaging the patients' arteries with ultrasound. We will~     also measure how cost-effective it is for a hospital to run the program.~      It is our goal to develop a community health worker model that is culturally sensitive for~     people with cultural, educational or educational barriers. Statin use is known to benefit~     patients in theory; such a culturally competent program will improve health outcomes in~     practice. After we test it, a cost-effective program such as this can be implemented in other~     hospitals.~   "
239050|NCT00426218|"~     This study is a multi-center, open label, repeated dose, range finding study to evaluate the~     safety, tolerability, immunogenicity, pharmacokinetics and efficacy of ACZ885, a fully human~     anti-interleukin-1B (anti-IL-1B) monoclonal antibody, given subcutaneously in pediatric~     subjects with active SJIA.~   "
239051|NCT00426205|"~     The purpose of this study is to investigate whether the addition of a vaccine after~     participants reduced intensity transplant will be safe and beneficial. The vaccine used in~     this trial, called GVAX, will be made from the participants own leukemia cells, and will be~     given between 1-4 months after transplant. In recent years, researchers have discovered that~     GVAX vaccine made from the patient's own cancer calls that have been engineered in the~     laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful~     immune response specific to that cancer.~   "
239052|NCT00426192|"~     After cardiac surgery with cardiopulmonar bypass, the LPS-stimulated cytokine response has~     been previously shown to be depressed. Therefore, in this trial the hypothesis was tested,~     whether simple immunomodulting interventions like the i.v. adminstration of mannitol of~     hemofiltration during cardipulmonary bypass can attenuate this immunosuppressing effect.~   "
239053|NCT00426179|"~     This study will assess the effects of Imatinib on allergic inflammation following repeated~     nasal allergen challenge in subjects with seasonal allergic rhinitis sensitive to Timothy~     grass pollen.~   "
239054|NCT00426166|"~     The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can~     reduce pain and/or improve wound healing in patients with an acute traumatic injury to the~     upper extremity (wrist, forearm, or elbow).~   "
239055|NCT00426153|"~     This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with~     severe polycystic liver disease who are not candidates or decline surgical treatments such as~     liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients~     will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence~     indicates that this drug is safe and non-toxic in other disease states. Treatment with this~     drug holds promise not only for individuals with liver involvement, but also for many more~     patients with polycystic kidney disease.~   "
239056|NCT00426140|"~     The main purpose of this study is to characterize the distribution, metabolism, and~     elimination (ADME) of Patupilone after a single intravenous administration in patients with~     advanced solid tumor malignancies~   "
239057|NCT00426127|"~     The purpose of this study is to assess the effects of the treatment combination of the~     commercially available chemotherapy drugs, docetaxel and liposomal doxorubicin, and a blood~     thinner Enoxaparin on pancreatic cancer. The main goal of the study is to find out if this~     combination chemotherapy and enoxaparin increases the number of individuals whose tumors~     shrink.~   "
239058|NCT00426114|"~     Patients with peritoneal dialysis will be administered an IV glucose-injection to evaluate~     the haemodynamic impact of this injection. The patients will be matched with healthy~     volunteers.~   "
239059|NCT00426101|"~     Without therapy HLH is often fatal, and often rapidly fatal. The treatment protocol HLH-94~     has improved survival markedly as compared to the survival earlier. We now aim to improve~     survival further.~   "
239060|NCT00426075|"~     Prospective controlled randomized clinical trial. Consecutive patients with acute proximal~     deep vein thrombosis of the lower extremities, with or without contemporary manifestations of~     pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated~     compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic~     syndrome (PTS). All patients are followed up to three years to assess the development of the~     PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is~     compared between the two study groups. In addition, there is an assessment of patients'~     compliance and tolerability of the two different devices.~   "
252421|NCT00247637|"~     This is a study of the genetic basis of brain dysfunction in people with schizophrenia.~   "
239062|NCT00426049|"~     The purpose of the present study is to provide the first in-human safety and efficacy~     evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in~     patients treated by bare metal stents for significant coronary artery disease. The aim is to~     reduce Major Adverse Cardiac Events (MACEs) including death, coronary artery bypass grafting~     (CABG) to the target vessel, Q-wave and non-Q-wave myocardial infarction, and target lesion~     revascularization within the first 6 months after intervention. Additionally safety and~     tolerability of Everolimus at the selected dose in this patient population will be analyzed.~   "
239063|NCT00426036|"~     This study will assess the influence of severe renal impairment on the pharmacokinetics of~     licarbazepine and its glucuronide conjugate after single oral administration in healthy~     subjects and in subjects with stable impaired renal function.~   "
239064|NCT00426023|"~     This interventional study aims to evaluate the efficacy of Cyclosporine eye drop treatment in~     preventing relapses of Vernal Keratoconjunctivitis (VKC) and in treating the acute phases of~     the disease.~   "
239065|NCT00426010|"~     We propose to measure the effect of placebo by elimination as well as by a balanced placebo~     design, determine its interaction with active drug, and explore whether placebo exerts part~     of its effect at the pharmacokinetics level.~   "
239066|NCT00425997|"~     This study will evaluate the efficacy of valsartan/hydrochlorothiazide versus amlodipine and~     hydrochlorothiazide in patients with Stage 2 hypertension using 24-hr ambulatory blood~     pressure monitoring (ABPM)~   "
239067|NCT00425984|"~     Circumcision in HIV unifected men may reduce the likelihood of becoming infected with HIV,~     reduce sexually transmitted infections (STIs) in men, not engender increases in sexual risk~     behaviors, and be acceptable to men as a procedure for preventing HIV. The purpose of this~     study is to evaluate circumcision in HIV uninfected men in terms of safety and ability to~     prevent HIV infection.~   "
239068|NCT00425971|"~     BMEC-1217B is an abbreviated version of an old Chinese formulation. The ratio of each~     component was adopted by the sponsor following the observation that BMEC-1217B prepared from~     this ratio resulted in best pharmacological profile and in vitro bioactivities.~      BMEC-1217B was studied for the pharmacological activity on the release of cysteinyl~     leukotrienes, IL-4 and TNF-alpha in vitro and the airway hyperreactivity. The result~     indicated that BMEC-1217B can inhibit the synthesis of several key pro-inflammatory mediators~     involved in the pathophysiology of allergic asthma and can also improve lung function in a~     mouse model of allergic asthma.~      The purpose of this study is to evaluate the safety and tolerability of increasing dose of~     BMEC-1217B when administered orally in healthy volunteers.~   "
239069|NCT00425958|"~     The purpose of this research is to find whether or not there are differences in the executive~     functions during shopping in a virtual mall, between children with Acquired Brain Injury~     (ABI) vs healthy children.~      The hypothesis is that there will be differences in time (more time to shop) and mistakes~     (more mistakes during shopping), in the ABI group.~   "
239070|NCT00425945|"~     The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku,~     Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and~     plasma lipoprotein profile.~   "
239071|NCT00425932|"~     The purpose of this study is to further investigate rituximab in the treatment of rheumatoid~     arthritis and to evaluate magnetic resonance imaging of the joints as a possible method to~     improve the evaluation of treatments.~   "
239072|NCT00425919|"~     The purpose of this study is to learn whether PPM-204 has an effect on lowering blood glucose~     (blood sugar) levels and is safe in treating people with type 2 diabetes.~   "
239073|NCT00425906|"~     RATIONALE: The use of a nicotine inhaler may help decrease appetite and relieve hunger pain~     (an intense craving for food) in patients with malignant bowel obstruction caused by cancer.~      PURPOSE: This randomized clinical trial is studying the side effects and how well a nicotine~     inhaler works in treating hunger pain in patients with malignant bowel obstruction caused~     by cancer.~   "
239074|NCT00425893|"~     This study will test the effectiveness of face masks and hand cleaning in preventing the~     spread of influenza within households~   "
239075|NCT00425880|"~     Asthma and smoking during pregnancy cause significant morbidity in both the mother and the~     offspring. Asthma represents the most common respiratory disorder during pregnancy and~     smoking rates during pregnancy range from 15-30% in the United States. Maternal asthma and~     smoking during pregnancy have been shown to increase the rate of intrauterine growth~     retardation and preterm delivery, as well as increase the risk of wheeze, asthma, respiratory~     infections, and otitis media in children. However, controlled asthmatics during pregnancy~     have similar pregnancy outcomes to non-asthmatic pregnancies. Measurement of the fractional~     concentration of exhaled nitric oxide (FENO) is a new, easily performed, non-invasive method~     that has been used to assess airway inflammation in adults and children. The long term goal~     of this study is to establish baseline FENO values and to monitor airway disease in pregnant~     asthmatics, pregnant smokers and pregnant controls, and to correlate these levels with other~     inflammatory markers in the mothers and their offspring. These values will be correlated with~     current methods to diagnose and monitor disease control in these patients. The use of FENO~     levels in the pregnant asthmatic may prove to be a better method for monitoring disease~     control and titrating steroid doses in this population. Finally, this study may identify~     children at higher risk of developing asthma or allergic disease. This could serve to~     identify factors that may be modified to prevent or limit the development of these diseases~     in this population.~   "
239076|NCT00425867|"~     The present study will be undertaken to establish whether genetic variations of PAR1 could be~     involved in the occurrence of any of the placental syndromes of preterm delivery,~     preeclampsia, and/or small for gestational age babies and recurrent pregnancy loss.~   "
239077|NCT00425854|"~     The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW~     2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with~     HER2-negative breast cancer after failure of no more than three regimen of prior~     chemotherapy.~   "
239089|NCT00425685|"~     ECMO offers an acceptable cardiopulmonary support in adults with similar hospital survival~     rates as other mechanical support. It is versatile and salvages some patients, who may~     otherwise die. Improvement in intermediate term outcome will require multidisciplinary~     approach to protect organ function and limit organ injury during this support.~   "
239078|NCT00425841|"~     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor~     and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving stereotactic radiation therapy together with~     combination chemotherapy before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed. Giving combination chemotherapy after surgery may~     kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving stereotactic radiation therapy~     together with combination chemotherapy works in treating patients undergoing surgery for~     locally advanced pancreatic cancer.~   "
239079|NCT00425815|"~     The TURNS is a National Institute of Mental Health (NIMH) funded contract for the evaluation~     of new compounds for the treatment of cognitive impairments in schizophrenia (HHSN 27820044~     1003C; P.I.: Steve Marder, M.D.). Despite advances in the safety, tolerability, and~     effectiveness of antipsychotic medications for the treatment of schizophrenia, many patients~     continue to be plagued by impairments in social and work functioning. Persons with~     schizophrenia commonly show deficits in a number of areas of cognition that include~     impairments in attention, memory, and executive functioning (the ability and organize one's~     behavior). Importantly, a large body of literature now shows a link between cognition and~     community functioning in schizophrenia. It is believed that treatments that improve cognitive~     deficits may lead to improvements in work and social functioning.~      A promising approach to improve the community functioning of patients with schizophrenia is~     to develop new agents that treat the cognitive deficits of the illness. One type of~     pharmacological compound that has shown promise at improving cognition is a group of drugs~     called ampakines. These drugs are believed to improve the activity of a neurotransmitter~     system in the brain called the glutamate system. Increased activity of this system has been~     linked to improvements in cognitive functioning. The current study is an eight-week trial~     comparing two doses of the ampakine drug, Org 24448, that will be added to patients' current~     atypical antipsychotic medication. One hundred thirty-five patients with schizophrenia, drawn~     from seven sites, will participate in the study. Cognition will be measured using a variety~     of paper-and-pencil and computerized measures from the consensus-derived NIMH Measurement and~     Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognitive battery.~     Psychiatric symptoms and the ability to perform community-based tasks of daily living will~     also be measured. Because previous trials with this drug and other similar drugs have~     detected lasting cognitive benefits, this trial will also repeat clinical assessments four~     weeks after completion of the study medication.~   "
239080|NCT00425802|"~     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem~     cell transplant helps stop the growth of cancer cells. It also helps stop the patient's~     immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as~     rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to~     them without harming normal cells. The donated stem cells may replace the patient's immune~     cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving rituximab before transplant and cyclosporine and mycophenolate mofetil after~     transplant may stop this from happening.~      PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy~     and radiation therapy together with rituximab and donor stem cell transplant works in~     treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.~   "
239081|NCT00425789|"~     To evaluate whether treatment with Hyperbaric oxygen can accelerate skin recovery after deep~     peeling, and decrease frequency and severity of local side effects and complications.~      20 post peel patients will recieve 5 daily hyperbaric treatments, starting from day 7 to~     peel.Patient's followup will include self- filling questionnaire and photographs~   "
239082|NCT00425776|"~     In a randomized 3-group clinical study acupuncture is used for the relief of menopausal hot~     flushes and sleep disturbances in women treated for breastcancer.~      The three groups consists of 35 women given acupuncture once a week five times and 35 women~     given shamacupuncture once a week five times and 35 women with no kind of treatment.~     Se-estradiol and endorphin is measured before and after the acupuncture.~      We want to state that acupuncture given five times once a week has a significant better~     effect on hot flushes and sleeping disturbances than shamacupuncture or no treatment at all.~      We also want to measure if there are any changes in se-estradiol and endorphine~   "
239083|NCT00425763|"~     We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied~     in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to~     correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria~     for each regimen.~   "
239084|NCT00425750|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to~     the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     bortezomib together with docetaxel may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with docetaxel~     works in treating patients with recurrent or metastatic head and neck cancer.~   "
239085|NCT00425737|"~     To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine~     (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with~     human rotavirus~   "
239086|NCT00425724|"~     No curative treatment of severe HSP nephritis is known.~      Apart from corticosteroids, immunosuppressive drugs, such as azathioprine and~     cyclophosphamide, have been used to treat severe HSP nephritis.Limited patient series treated~     with these drugs have been described, but there are no reports of controlled trials.~      Cyclosporine A have been used to treat corticosteroid-resistant or corticosteroid-dependent~     nephrosis. (11) Cyclosporine A has also been used to treat HSP nephritis, but as far as we~     know, there are no publications reporting such trials.~      The aim of the study is to compare MP pulses and cyclosporine A for their efficacy in the~     treatment of HSP nephritis.~      The efficacy of the two treatments will be assessed on the basis of the duration of~     nephrosis/nephritis, the maintenance of renal function and the renal biopsy findings.~   "
239087|NCT00425711|"~     Acamprosate will be given to approximately 30 DUI Court participants for 3 months and~     outcomes will be monitored. The hypothesis is that acamprosate will be safe and~     well-tolerated and that subjects' craving and other symptoms related to addiction will~     improve over time.~   "
239088|NCT00425698|"~     The hematopoetic cytokine erythropoietin (EPO) has been shown to reduce programmed cell death~     and tissue destruction in experimental models of acute kidney ischemia-reperfusion injury.~     Thus, treatment with high dose recombinant human EPO (rHuEPO) may prevent kidney tissue~     damage and loss of renal function after successful kidney transplantation in humans.~   "
239090|NCT00425672|"~     RATIONALE: ONTAK may be able to help reduce the type of cells that prevent other types of~     immune cells from attacking the breast cancer cells.~      PURPOSE: This phase I/II trial is studying the safety of ONTAK and its possible side effects~     to see how well it works in treating patients with advanced breast cancer that did not~     respond to previous treatment.~   "
239091|NCT00425659|"~     Newer home sleep study device and algorithm provides an alternative for inpatient sleep study~     and improve the service provides to patients~   "
239092|NCT00425646|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Imatinib~     mesylate and bevacizumab may also stop the growth of tumor cells by blocking blood flow to~     the tumor. Giving imatinib mesylate together with bevacizumab as maintenance therapy may stop~     non-small cell lung cancer from growing or coming back.~      PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with~     bevacizumab after first-line chemotherapy and bevacizumab works in treating patients with~     stage IIIB or stage IV non-small cell lung cancer.~   "
239093|NCT00425633|"~     The purpose of this study is to find out whether homeopathic potassium dichromate will~     decrease the time on the breathing machine and the amount of phlegm that you produce in your~     lungs. In addition, this study will look at whether participants spend less time in a~     critical care unit and if the chances of being placed back on a breathing machine can be~     lessened.~   "
239094|NCT00425620|"~     The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B~     suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during~     16 weeks of treatment in patients with refractory, postsurgical CS.~   "
239095|NCT00425607|"~     This is an open label dose adjusted phase II trial of the oral farnesyltransferase inhibitor~     (FTI) lonafarnib (SCH66336) for patients with HGPS and progeroid laminopathies.~   "
239096|NCT00425594|"~     This randomized, parallel, multi-center, single-blind study is designed to compare the safety~     and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy~     for a routinely accepted indication.~   "
239097|NCT00425581|"~     The primary objective is to test the hypothesis that there is an association between the~     hemodynamic status and the serum levels of NT-proBNP and cTnT in prematurely born infants. We~     would also evaluate the hypothesis that there is an association between the level of these~     proteins in the serum and the short and long term morbidity.~   "
239098|NCT00425568|"~     Low testosterone may be responsible for soft erections in men. The purpose of our study is~     to see whether the daily application of a testosterone gel to raise testosterone levels will~     also increase the hardness of a man's erection.~   "
239099|NCT00425555|"~     This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory~     Cutaneous T-Cell Lymphoma.~   "
239100|NCT00425542|"~     The purpose of this randomized clinical trial is to determine whether outpatient treatment is~     as effective and safe as inpatient treatment among low-risk patients with pulmonary embolism.~   "
239101|NCT00425529|"~     The primary objective of this clinical trial is to test the tolerance and practicality of the~     new device Module AOX.~      The secondary objective is to determine the changes in oxidative, antioxidative status,~     plasma free amino acids, and various immune parameters in critically ill patients receiving~     the enteral nutrition with and without using Module AOX.~   "
239102|NCT00425516|"~     Neoadjuvant chemotherapy, known as first or induction chemotherapy in the therapeutic~     assumption of breast cancer is based on the narrow dependence preclinically revealed between~     primary tumour, tumoral angiogenesis and growth of distant metastases.~      The results of the Aberdeen Group (Smith et al, 2002 ; Hutcheon et al, 2003), of the NSABP~     B27 trial (Bear et al, 2003) and of the Gepar-Duo Group (Von Minckwitz et al, 2002) have~     shown that a sequential protocol, using docetaxel after an anthracycline-based combination,~     allowed a better clinical response leading to more frequent conservative surgeries and, more~     importantly, to an increase in the rate of complete pathological response, assessing a better~     efficacy.~      The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible~     because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and~     the same chemotherapy given as an induction treatment Even keeping the principle of a~     sequential treatment, a crucial question is to know if this sequential treatment should be~     the same for all patients, or if the oncologist could get a better complete pathological~     response, disease-free or overall survival rates by an adaptation of treatment to the~     objective result beginning after 2 FEC 100 courses by modulation of the following courses.~      We will use as a primary regimen 3 FEC cycles + 3 TAXOTERE cycles, a standard adjuvant~     regimen (noted in the Temporary Protocol of Treatment of the Inca page 5 (October 2005) as~     well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy (Oncologie --~     volume 7 - N°5, August 2005, p 370). This standard treatment will be compared to the same~     chemotherapy modulated in its repartition according to results obtained by subsequent tumor~     evaluations during induction therapy.~   "
239103|NCT00425503|"~     Following pretreatment evaluation, patients receive PS-341 by intravenous push weekly for 4~     consecutive weeks followed by a 24-72 hour rest period. This schedule consists of one~     treatment cycle. Upon the completion of 4 weeks of PS-341 followed by a 24-72 hour rest~     period, radical prostatectomy will be performed. Surgery will be delayed if there is any~     bleeding abnormality (bleeding time greater than 10 minutes) and until platelet count is more~     than or equal to 100,000 and coagulation profile (PT, PTT) is normal. If at the time of~     surgery a patient is found to have positive lymph nodes, prostatectomy will be abandoned, the~     prostate will be biopsied, and the patient will be offered other treatment modalities~     (hormones, radiation therapy).~   "
239104|NCT00425490|"~     The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100~     mg/day on the insulin secretion capacity of beta cells.~      Patients who meet the study enrollment criteria will undergo 2 experiments (see description~     below); a graded hyperglycemic technique and a meal test, prior to randomization and after a~     12-wk double-blind study period. The treatment effect will shed light on the magnitude of the~     beta cell capacity to increase its mass and function.~   "
239105|NCT00425477|"~     RATIONALE: Bexarotene may help cancer or abnormal cells become more like normal cells, and to~     grow and spread more slowly. Colony-stimulating factors, such as GM-CSF, may increase the~     number of immune cells found in bone marrow or peripheral blood. Giving bexarotene together~     with GM-CSF may be an effective treatment for myelodysplastic syndrome (MDS) or acute myeloid~     leukemia.~      PURPOSE: This phase II trial is studying how well giving bexarotene together with GM-CSF~     works in treating patients with MDS or acute myeloid leukemia.~   "
239106|NCT00425464|"~     The purpose of the study is to determine if the Synchrony Dual Optic Accommodating~     Intraocular Lens can be used safely and effectively in post cataract extraction subjects~   "
239107|NCT00425451|"~     The purpose of this study is to determine the effect of the placement of a PerioChip Plus~     (flurbiprofen/chlorhexidine - FBP/CHX) formulation versus PerioChip (chlorhexidine)~     formulation versus Flurbiprofen Chip formulation versus Placebo Chip formulation on probing~     pocket depth (PPD)~   "
239108|NCT00425438|"~     This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids,~     versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine~     in the maintenance phase, in maintaining remission and renal function in patients with lupus~     nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for~     24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks,~     or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by~     azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate~     will be assessed at the end of the induction phase, and at the end of study. The anticipated~     time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
239109|NCT00425425|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also make tumor cells~     more sensitive to radiation therapy. Drugs used in chemotherapy, such as oxaliplatin and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving cetuximab, chemotherapy, and radiation therapy before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and~     fluorouracil when given together with cetuximab and radiation therapy and to see how well~     they work in treating patients with stage II or stage III esophageal cancer.~   "
239110|NCT00425399|"~     In the current study we will study the effect of adding shiatsu treatment to conventional~     therapy in work with hospitalized schizophrenic patients.~      The hypotheses of this study are several:~        1. Shiatsu can improve the patients' symptoms~        2. Shiatsu can ameliorate neuromuscular side effects produced by standard anti-psychotic~          treatment~        3. Shiatsu can provide patients with tools to deal with the stresses of their illness~      2. Methodology We propose an open pilot study in which a total of 20 patients of both sexes~     will be enrolled. These patients will be drawn from the inpatient psychiatric wards at Herzog~     Hospital.~      Upon inclusion into the trial, all participants will receive shiatsu treatment, consisting of~     two individual weekly 40-minute shiatsu treatment sessions for four weeks. Provider and~     patient will be of the same gender. Standard pharmacotherapy will be provided as needed~     during the treatment period. Medication and dosage will not be changed. If necessary,~     benzodiazepines will be administered as required.~      Outcome measures:~      The following assessments will be included:~        1. Medication: Use of SOS benzodiazepines~        2. Clinical rating scales: PANSS, CGI, NOSIE, Hamilton Scales for depression and anxiety~      1. Side effect scales: Simpson Angus Scale, AIMS scale, UKU scale 2. Neurophysiological~     testing: Prepulse inhibition (PPI). 3. Neurocognitive testing: This will be performed using~     the NIMH's Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)~     Consensus Cognitive Battery for Clinical Trials.~   "
239111|NCT00425386|"~     RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib~     together with erlotinib may kill more tumor cells.~      PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with~     sunitinib and to see how well they work in treating patients with unresectable or metastatic~     kidney cancer.~   "
239112|NCT00425373|"~     The purpose of this study is to evaluate the safety and efficacy of fixed combination of~     valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone,~     and placebo in reducing blood pressure. The study will investigate the dose response~     relationship for the combinations, monotherapies, and placebo.~   "
239113|NCT00425360|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Vaccines made from peptides may help the body build an effective immune~     response to kill tumor cells. Giving more than one drug (combination chemotherapy) together~     with vaccine therapy may kill more tumor cells. It is not yet known whether chemotherapy is~     more effective with or without vaccine therapy in treating pancreatic cancer.~      PURPOSE: This randomized phase III trial is studying gemcitabine, capecitabine, and vaccine~     therapy to see how well they work compared with gemcitabine and capecitabine alone in~     treating patients with locally advanced or metastatic pancreatic cancer.~   "
239114|NCT00425347|"~     To identify the MTD of HuLuc63 administered intravenously (IV) for 4 doses.2. To evaluate the~     safety of HuLuc63 IV given every other week for 4 doses.~   "
239115|NCT00425334|"~     This is a progressive dose escalation study designed to evaluate the safety of Hemospan~     compared to a standard crystalloid solution (Ringer's lactate) in elective surgery patients~     undergoing total prostatectomy procedures with anticipated blood loss of more than 500 mL.~     Secondary objectives of this study are to observe possible activity of Hemospan for tissue~     oxygenation, perfusion and cardiovascular support.~   "
239116|NCT00425321|"~     The primary objective of the study is to evaluate the safety and tolerability of 100, 200,~     and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid~     Arthritis despite methotrexate therapy.~   "
240739|NCT00403702|"~     The purpose of the study is to compare the safety, intraocular adverse effects and the~     anatomic and functional outcome with two endotamponade silicone oil after a 3-month in~     complex inferior retinal re-detachments.~   "
239117|NCT00425308|"~     Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine~     microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate~     Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in~     study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely~     discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine~     microemulsion + steroids).~   "
239118|NCT00425295|"~     The main purpose of this study is to assess the effectiveness of human simulation in the~     training of the leadership, cognitive, and psychomotor skills required to lead medical crisis~     management teams. All participants in the study are trainees in the University of Pittsburgh~     Medical Center (UPMC) Multi-Disciplinary Critical Care Training Program (MCCTP.) All trainees~     will have received the standard critical care medicine-training curriculum including basic~     airway management, management of hypotension, unstable cardiac arrhythmias, difficult airway~     management and crisis team training. The participants will have also completed six months of~     baseline clinical training, which includes responding to medical emergencies at UPMC.~      The specific aims of this study are:~        1. To assess the effectiveness of Human Simulation Training (HST) as an educational tool~          for teaching medical crisis management.~        2. To determine the effect of HST on objective measures of performance in the domains of~          communication, leadership, cognition and psychomotor skills.~   "
239119|NCT00425282|"~     The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on~     treatment of partial onset seizures.~   "
239120|NCT00425269|"~     Immigrants from South Asia in Norway have a high prevalence of type 2 diabetes and conditions~     related to the metabolic syndrome. It has been documented that these conditions may be~     prevented by changes in lifestyle. No previous intervention studies on immigrants with focus~     on diet and physical activity have been carried out in Norway. This project concerns a~     randomized controlled trial with intervention to change diet and physical activity in 200~     high risk female Pakistani immigrants living in Oslo. The intervention will be evaluated both~     in terms of outcome and process.~   "
239121|NCT00425256|"~     This 8 week at home study is designed to explore efficacy endpoints and evaluate the safety~     of intranasal Bremelanotide in women with Female Sexual Arousal Disorder. Efficacy will be~     assessed vs. a parallel placebo group.~   "
239122|NCT00425243|"~     The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5~     mg in comparison with placebo, when administered over a long-term period, on an as needed~     basis, in patients with chronic primary insomnia.~      Secondary objectives of the study are to evaluate the drug taking behavior over a long-term~     period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to~     placebo administered over a long-term period, on an as needed basis.~   "
239123|NCT00425230|"~     This is a study to assess the possible benefit of duloxetine in the treatment of chronic~     phantom limb pain.~   "
239124|NCT00425217|"~     Membranous glomerulopathy (MN) is a common immune-mediated glomerular disease and the leading~     cause of nephrotic syndrome in Caucasian adults. 1 Because of its frequency, it remains the~     second or third cause of end-stage renal disease caused by a primary glomerulonephritis. 2 At~     presentation, 70% to 80% of patients have the nephrotic syndrome. 1, 3, 4 Proteinuria greater~     than 2.0 grams per day is found in > 80% of patients at presentation, with greater than 10~     grams found in as many as 30%. 5 The disease affects patients of all ages, but it is most~     often diagnosed in middle age with the peak incidence during the fourth and fifth decades of~     life. There is close to a two-to-one predominance of males to females diagnosed with the~     disease. Idiopathic MN affects all races. Current therapeutic options include corticosteroids~     alone or in combination with alkylating agents, cyclosporin A, and mycophenolate mofetil. The~     most widely recognized, and best-validated regimen is combination therapy with~     corticosteroids and an alkylating agent, but its use is associated with significant adverse~     effects. Recent meta-analysis confirmed that present day treatments are far from ideal 6~     Thus, it should not come as a surprise that the outcome of MN has not substantially improved~     over the past 30 years, and up to 40% of patients still progress to end-stage renal failure.~     7 Like in other glomerular diseases the amount of protein in the urine correlates well with~     long term prognosis. Thus, this parameter has been used in previous studies, and will be used~     in this study, as the primary indicator of effectiveness of therapy. We proposed to do a~     pilot study to test the hypothesis that selective B lymphocyte depletion will result in~     disappearance of pathogenic antibodies and induction of remission of the nephrotic syndrome~     in patients with idiopathic membranous nephropathy. Our population will be 10 adults. The~     study will be conducted between our Nephrology Divisions at Mayo Clinic Rochester,~     Jacksonville, and Scottsdale. We will enroll patients with a GFR 25 ml/min as estimated by~     creatinine clearance and proteinuria > 4g/24h, while receiving an ACEI or ARB and with BP~     controlled of < 130/80 mmHg. Patients will receive Rituximab 1g on Day 1 and 15. Patients~     followed for 1 years following completion of treatment. The primary outcome will be change in~     urinary protein excretion at 6 months. Secondary outcomes will be changes in serum albumin,~     serum lipid?s profile, the number of partial remissions, time to remission, and incidence of~     relapses. We will also perform a pharmacokinetic study to evaluate the effect of proteinuria~     on the bio-availability and effects of the drug.~   "
239125|NCT00425204|"~     A multi-center, open-label, extended treatment, clinical trial examining the safety of~     administering multiple does of panitumumab by intravenous (i.v.) infusion to patients who~     have previously received panitumumab and benefited from treatment~   "
239126|NCT00425191|"~     To assess the antitumour activity (response rate) in patients with locally advanced or~     metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and~     gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as~     first line chemotherapy · To evaluate the quantitative and qualitative toxicity of each~     treatment arms.· To determine time to progression, duration of response, time to treatment~     failure, and overall survival in each group.· To evaluate changes from baseline in the Lung~     Cancer Symptom Scale of patients in each treatment arm.~   "
239127|NCT00425178|"~     FGF-1 is being used for the treatment of patients with diabetic or venous stasis ulcers.~     Procedure includes topical administration of FGF-1 or placebo and evaluation of safety,~     pharmacokinetics, and wound improvement.~   "
239128|NCT00425165|"~     The purpose of this trial is to evaluate the effects of a single dose of denufosol versus~     placebo on mucociliary clearance in patients with mild to moderate CF lung disease~   "
239157|NCT00424762|"~     The purpose of this study is to determine if rosiglitazone treatment improves integrated~     cardiovascular performance in patients at risk for congestive heart failure. A second aim of~     this study is to determine if treatment with rosiglitazone decreases intracellular (ectopic)~     triglyceride (TG) deposition in cardiomyocytes using nuclear magnetic resonance (NMR)~     techniques, and how changes in intra-myocardial lipid content relate to changes in cardiac~     structure and function.~   "
239925|NCT00414622|"~     A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of~     GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days~     to Participants With Probable Alzheimer’s Disease~   "
239129|NCT00425152|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Leucovorin may help fluorouracil kill more tumor cells. Biological therapies, such as~     levamisole, may interfere with the growth of tumor cells and slow the growth of solid tumors.~     It is not yet known whether fluorouracil is more effective when given together with~     leucovorin and/or levamisole after surgery in treating colon cancer.~      PURPOSE: This randomized phase III trial is studying giving fluorouracil together with~     leucovorin to see how well it works compared with giving fluorouracil together with~     levamisole, or giving fluorouracil together with leucovorin and levamisole after surgery in~     treating patients with Dukes' B or Dukes' C colon cancer.~   "
239130|NCT00425139|"~     The purpose of this study is to determine the effects of playing the interactive video game,~     Re-Mission, on patient outcomes, including adherence to medical treatment regimes, self-care~     behaviors, quality of life, stress, communication, control, and knowledge.~   "
239131|NCT00425126|"~     Delayed graft function (DGF) is a major complication following deceased donor renal~     transplantation. The surgical procedure of harvesting a kidney from a cadaveric donor and~     implanting the kidney into the recipient inevitably causes some amount of injury. While not~     always clinically significant, anywhere from 10-50% of transplant patients may develop DGF.~     Ongoing research in animal models has demonstrated benefit with administration of~     erythropoietin. The investigators propose to study the effect of Procrit(Epoetin Alfa) on~     delayed graft function in subjects undergoing kidney transplantation.~   "
239132|NCT00425113|"~     This study will evaluate the effect of adding metronidazole to standard second-line therapy~     for tuberculosis in patients who have multi-drug resistant tuberculosis (MDR-TB) of the~     lungs. It will evaluate the safety and tolerability of metronidazole in combination with~     antituberculosis agents. Metronidazole is a drug widely used to treat bacterial and parasitic~     infections occurring in environments with very little oxygen such as the human colon. Nine~     million new cases of sputum-positive tuberculosis are diagnosed worldwide each year.~      Patients ages 20 and older who have symptoms of TB, who have been treated for tuberculosis~     but whose disease is multi-drug resistant, and who are not pregnant or breast feeding may be~     eligible for this study. They will be recruited in the National Masan Tuberculosis Hospital~     (NMTH), Masan, Republic of Korea. Patients will undergo the following tests and procedures:~        -  Collection of sputum for counting of bacteria.~        -  Drawing of blood for routine blood chemistry analysis; for measuring levels of~          metronidazole; TB lipid analysis; and for testing levels of T-cells, which are part of~          an immune response.~        -  Two targeted positron emission tomography (PET) scans, each with a computed tomography~          (CT) scan, and five high-resolution CT scans.~      Patients will receive either an 8-week course of standard second-line agents plus placebo~     (sugar pill) or an 8-week course of standard agents plus metronidazole. The subjects, doctors~     and researchers will not know which patients are taking the metronidazole until after the~     first 2 years of the trial. A total of 60 patients will be assigned to two cohorts of 30~     patients each. After 8 weeks, all patients will return to the standard of care chemotherapy,~     according to normal procedures at NMTH.~      Side effects of metronidazole commonly reported are vaginal discharge, symptoms of Candida~     cervicitis and vaginitis, headache, nausea and vomiting, and dizziness. Peripheral~     neuropathy, an abnormal condition of the nerves, may also be a side effect. The precise~     incidence of neuropathy is unknown but is usually related to the duration of metronidazole~     use. It can almost always be reversed when the drug is discontinued. Serious side effects,~     though rare, may include leukopenia and thrombocytopenia (disorders in the blood), seizures~     and other central nervous system problems, and hepatitis.~      This study may or may not have a direct benefit for participants. However, it is possible~     that patients' drug-resistant disease may be more effectively treated as a result of~     metronidazole. The study may help identify new methods for measuring drug effectiveness~     during TB studies.~   "
239133|NCT00425100|"~     To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB)~     symptom relief in OAB patients who were dissatisfied with their prior therapy with~     tolterodine.~   "
239134|NCT00425074|"~     The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic~     treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA:~     normal and the one of sustained release, in patients with stable coronary disease.~   "
239135|NCT00425061|"~     Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with~     persistent asthma.~   "
239136|NCT00425048|"~     Unconscious touching of a person's own head or neck (for example by scratching) is a~     frequently observed and completely normal physiological movement pattern in humans, which~     when done by medical personnel attending a patient poses a high risk of unconscious~     self-contamination, even of an already disinfected hand, and of subsequent contamination of~     the patient. However, as compared to an ungloved hand, a gloved hand is felt to be foreign,~     which could reduce the frequency of self-contact and thus the contamination rate.~      Wearing protective gloves is highly recommended in medical practice. The purpose of this~     study is to explore how wearing, or not wearing, protective gloves affects~        -  the frequency of unconscious self-contact~        -  contamination of the gloved/ungloved hand~   "
239137|NCT00425035|"~     Multicenter, 2-part, multiple-dose study designed to evaluate the safety and effectiveness of~     weekly administration of panitumumab in subjects with renal carcinoma. Part 1 was initiated~     in 2001 and will not be presented here. Part 2 was designed to examine a dose of 2.5 mg/kg/wk~     in 2 cohorts.~   "
239138|NCT00425022|"~     To examine the feasibility of VATS lobectomy for clinical stage IB or II non-small cell lung~     cancer. Success is defined as VATS lobectomy without conversion. If success rate over 90%,~     VATS lobectomy is considered as feasible procedures for clinical stage IB or II non-small~     cell lung cancer~   "
239139|NCT00425009|"~     The purpose of this study is to determine whether berberine is effective in the treatment of~     type 2 diabetes.~   "
239158|NCT00424749|"~     Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of~     eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS~     patients develop kidney disease. The goal of this pilot study was to evaluate the safety and~     effectiveness of Rituximab in inducing remission of kidney disease in patients with CSS.~   "
239159|NCT00424736|"~     Whole body imaging has no role in asymptomatic pediatric trauma patients~   "
239160|NCT00424723|"~     The purpose of this study is to find out what effects (good and bad) pemetrexed has on~     patients with advanced neuroendocrine tumors.~   "
239161|NCT00424710|"~     This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal~     choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography.~   "
239162|NCT00424697|"~     Data suggests that imaging activity of the brain can measure the effects of anti-anxiety~     drugs. This study will investigate the effect of GW876008 on areas of the brain involved with~     thinking and emotion~   "
239926|NCT00414609|"~     The core and extension studies assessed the safety and efficacy of aliskiren when added to~     optimized standard therapy in patients that have had a high risk acute myocardial infarction~     (heart attack).~   "
239140|NCT00424996|"~     Glaucoma is a chronic disease defined by characteristic changes in the optic nerve associated~     initially with loss of peripheral vision and is treated by lowering intraocular (inside the~     eye) pressure. It has been reported that noticeable changes to the optic nerve caused by~     glaucoma may occur several years before changes in vision are noticed. Since changes to the~     optic nerve and other eye structures due to glaucoma are irreversible, it is important to~     develop tools for the earliest possible detection of changes due to glaucoma.~      The Heidelberg Retina Tomograph (HRT) is a device that is used to produce a three-dimensional~     map of the optic nerve and retina, and can be used to detect changes in the optic nerve and~     retina over time. In previous studies, it has been shown to be useful for the detection of~     changes due to glaucoma. However, the HRT when compared to other techniques to evaluate the~     optic nerve such as stereophotography, was found to only somewhat agree.~      The current study will compare HRT to stereophotography to determine how good each one is at~     looking and documenting changes in the optic nerve over time due to glaucoma. Using HRT to~     initiate early topical medication or to change management requires knowing how well HRT~     results predict the development of visual loss. Accordingly, the results of this study may~     affect the management of glaucoma patients by optimizing the follow-up of people with this~     condition and by initiating appropriate and more individualized treatments. Early treatment~     is crucial for preventing further visual loss in patients with glaucoma or ocular~     hypertension (high pressure inside the eye).~   "
239141|NCT00424983|"~     The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK)~     profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients~     treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.~   "
239142|NCT00424970|"~     The prevalence of High Altitude Polycythemia (or Chronic Mountain Sickness) is between 8 and~     15% in the high altitude regions of South America. There is no pharmacological treatment~     available. After a first preliminary study in 2003 demonstrating the beneficial effects of~     acetazolamide in reducing hematocrit in these patients, after 3 weeks of treatment, we want~     to confirm this effect and implement a treatment protocol of 3 month-duration.~   "
239143|NCT00424957|"~     The purpose of the current study is to look into the pathogenesis of a severe medical~     condition causing acute episodes on the central nervous system as seen in majority of~     patients with liver cirrhosis.~   "
239144|NCT00424944|"~     The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already~     publicly used vaccine against rabies. 40 adult male Gabonese volunteers will be enrolled and~     randomly allocated to receive either malaria vaccine or rabies vaccine without the~     investigator or the participants knowing what they received. They will receive 3 doses each~     at one month intervals, and will be followed up for one year to evaluate safety parameters.~      This is the first time this product will be tested in Africa~   "
239145|NCT00424931|"~     The purpose of this study is to evaluate the safety and effectiveness of JNJ-17216498~     compared to modafinil and placebo in patients with narcolepsy, with and without cataplexy.~   "
239146|NCT00424918|"~     In middle schools participating in a statewide program called Take Time, we are randomizing~     youth to a 10-12 week intervention using the dance mat games on the Playstation2 (like Dance~     Dance Revolution). This program is testing feasibility of using the dance mats as a way to~     increase activity during the school day. We are using Groove Masters as a peer-mentored~     mechanism to keep track of the activity of youth in the intervention compared to the control~     group. Our main objective is increase in activity time.~   "
239147|NCT00424905|"~     To assess the effects of Bacillus clausii (Enterogermina®) on fecal microbial flora (using~     Polymerase Chain Reaction - Denaturing Gradient Gel Electrophoresis - PCR-DGGE - Method) in~     antibiotic-treated children with complicated acute otitis media or beta-hemolytic~     streptococcal pharyngo-tonsillitis.~   "
239148|NCT00424892|"~     The primary objective is to evaluate the long-term safety of desvenlafaxine succinate~     sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia~     syndrome.~   "
239149|NCT00424866|"~     FGF-1 for the treatment of patients with peripheral arterial disease with intermittent~     claudication.~   "
239150|NCT00424853|"~     This is a multicenter, open-label, randomized phase II trial whose aim is to assess the~     antitumor activity of two sequential schedules of docetaxel and cisplatin followed by~     gemcitabine.~   "
239151|NCT00424840|"~     The primary objective of phase I study is to define the maximum tolerated dose (MTD) of~     weekly bortezomib in combination with Carboplatin and Bevacizumab~      The primary objective of phase II study is to estimate the efficacy (response rate and~     progression free survival) and safety of combination therapy with Carboplatin, bortezomib and~     bevacizumab as first line therapy in patients with advanced NSCLC.~      The secondary objectives of this study are to estimate the time to progression, duration of~     response, and overall survival~   "
239152|NCT00424827|"~     This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and~     external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic~     cancer.~   "
239153|NCT00424814|"~     In the pre-partum phase the use of antiretroviral therapy for the mother during the last~     trimester of pregnancy is mandatory. The use of HAART during pregnancy, usually two~     nucleosides analogues and a protease inhibitor exposes the mother and the child to cumulate~     toxicities related to both families. The aim of this study is to assess the use of a boosted~     protease inhibitor without nucleoside analogue during the pre-partum phase for women with no~     indication of antiretroviral therapy for their own.~   "
239154|NCT00424801|"~     The purpose of this study is to determine if long-term vasodilatory treatment is more~     effective than the standard treatment in hypertensive patients with microvascular angina~     pectoris~   "
239155|NCT00424788|"~     Natalizumab (TYSABRI) is a protein-based drug that is manufactured by Biogen Idec in~     partnership with Elan Pharmaceuticals. Natalizumab is approved in the US and Europe for the~     treatment of Multiple Sclerosis (MS). The purpose of this study is to determine whether the~     amount of natalizumab (TYSABRI) that is present in your blood (plasma) can be reduced or~     eliminated by separating and removing the plasma and replacing it with other fluids, a~     process called plasma exchange.~   "
239156|NCT00424775|"~     The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in~     combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.~   "
239163|NCT00424684|"~     Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant~     recipients. Management of tuberculosis in this setting is challenging due to the complexity~     of diagnosis and the potential toxicity of anti-TB therapy, especially in liver transplant~     candidates and recipients. Although the tuberculin skin test (TST) is recommended for~     screening of latent tuberculosis infection (LTBI) in all candidates for liver~     transplantation, the performance of the TST in this setting is less than optimal, due to a~     lack of specificity (false-positive results due to interaction with BCG vaccine and other~     mycobacterial infections), and a lack of sensitivity in a population that is relatively~     immunocompromised. Recently, a new test named QuantiFERON-TB Gold (QFT-G) has been approved~     for the diagnosis of LTBI. QFT-G detects the release of interferon-gamma (IFN-γ) by~     sensitized white cells after incubation of whole blood with TB antigens. QFT-G is expected to~     be more specific than TST. However, there are no studies defining the performance of QFT-G in~     a population of patients on a waiting list for liver transplantation. We plan to estimate the~     usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage~     liver disease. We hypothesize that the QFT-G test will correlate better with the risk of~     LTBI. This study advances research on the prevention of a serious bacterial infection that~     can have devastating consequences in the post-transplant setting. The new diagnostic strategy~     may more accurately determine the presence of LTBI, thereby allowing appropriate therapy.~   "
239164|NCT00424671|"~     This study will assess the influence of moderate hepatic impairment on the pharmacokinetics~     of licarbazepine after single oral administration in healthy subjects and in subjects with~     stable impaired hepatic function.~   "
239165|NCT00424658|"~     When a disorder is as prevalent as sleep apnea hypopnea syndrome various medical levels and~     strategies should be implicated. We to evaluate the degree of concordance in management~     between a sleep reference centre and non-reference centres.~   "
239166|NCT00424645|"~     Primary Objectives:~        1. To evaluate the efficacy of Glucarpidase (Voraxaze) in increasing the rate of~          methotrexate (MTX) clearance following high dose MTX treatment in patients with a~          delayed MTX clearance.~        2. To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment~          in patients with a delayed MTX clearance.~        3. To evaluate the safety profile of Glucarpidase following high dose MTX treatment in~          patients with a delayed MTX clearance.~      Secondary Objectives:~        1. To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of~          intravenous (IV) antibiotics.~        2. To evaluate the effect of Glucarpidase on the length of hospitalization.~        3. To evaluate the effect of Glucarpidase on renal function.~        4. To evaluate the effect of Glucarpidase on Quality of Life (QOL).~        5. To evaluate the anti-glucarpidase antibody response.~        6. To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high~          dose MTX treatment.~   "
239167|NCT00424632|"~     The purpose of this study is to determine the maximum tolerated dose and recommended phase 2~     dose of PF-03814735 administered orally as single agent in patients with advanced solid~     tumors.~   "
239168|NCT00424619|"~     The purpose of the study is to determine the best dose of Vitamin D to give to hip fracture~     patients to achieve the optimal therapeutic level.~   "
239169|NCT00424606|"~     The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an~     important part of the chemotherapy regimens used in the adjuvant setting of patients with~     early-stage node-positive breast cancer patients. Whether sequential or concurrent~     administration of these drugs is preferable is not yet known, especially in patients with~     node-negative high risk tumors.~   "
239170|NCT00424593|"~     The primary purpose of your participation in this study is to help answer the following~     research question, and not to provide you treatment for your condition.~      Whether duloxetine once daily can help patients with Chronic Low Back Pain.~      Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg~     dose for the duration of the study. After the 13 week double blind period, patients~     randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension~     period.~   "
239171|NCT00424580|"~     Montelukast (for asthma) and desloratadine (for allergies) are effective therapy for their~     current uses. Part of what happens when your allergies trigger your asthma should be~     prevented by either of these drugs. This project is being conducted to determine if these~     drugs are effective, either alone or in combination, on controlling asthma that is triggered~     by allergies.~   "
239172|NCT00424567|"~     The purpose of this multi-center study is to obtain clinical data to substantiate that~     Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established~     (appendicular skeletal) non union fractures, when used with one of the commonly employed~     commercially available allograft chip matrices.~   "
239173|NCT00424554|"~     The main purpose of this study is to assess the effect of a two-week pre-surgery treatment~     with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid)~     methyltransferase (MGMT) activity in patients with gliomas.~   "
239174|NCT00424541|"~     This study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the~     relationship among pharmacokinetics, renin-angiotensin system (RAS) biomarkers, and blood~     pressure lowering effects of oral doses of SPP100 in Japanese patients with mild to moderate~     essential hypertension. Safety will also be evaluated.~   "
239175|NCT00424528|"~     The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day~     and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects~     with Chronic Obstructive Pulmonary Disease (COPD).~   "
239176|NCT00424515|"~     The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating~     acral/lentiginous and mucosal melanoma which has spread to other parts of the body in~     patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It~     is believed that imatinib may be effective in blocking signals on certain cancer cells which~     allow the malignant cells to multiply and spread.~   "
239177|NCT00424502|"~     This single arm study will evaluate the efficacy and safety of MabThera in patients with~     active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced~     an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and~     will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on~     study treatment is 3-12 months, and the target sample size is <100 individuals.~   "
239178|NCT00424489|"~     MG may be neonatal, congenital, or autoimmune. Neonatal MG arises from transplacental~     transfer of ACh receptor antibodies from a mother with autoimmune MG to the fetus. Neonatal~     MG resolves with post delivery clearance of maternal antibodies. Congenital MG results from a~     genetic defect in the ACh receptor. Patients with congenital MG do not have ACh receptor~     antibodies. Both neonatal and congenital MG are excluded from this study. Autoimmune MG,~     which is the most common form of MG, affects approximately 25,000 Americans. Like most~     autoimmune diseases, it is associated with particular HLA genotypes, has a female~     predominance, and environmental factors involved in breaking tolerance to the ACh receptor~     are unknown. Patients with refractory and severe autoimmune MG will be considered candidates~     for this study.~      The purpose of this study is to assess the toxicity/feasibility (phase I) of autologous~     hematopoietic stem cell transplantation for refractory myasthenia gravis.~   "
239179|NCT00424476|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on~     quality of life of two different doses of belimumab administered in addition to standard~     therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE)~     disease.~   "
239180|NCT00424463|"~     This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This~     study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3,~     randomized, double-blind, placebo control, parallel assignment, 24-week study in the~     treatment of ALS. The objectives of this study are to assess the efficacy and safety of~     long-term intermittent therapy with 60 mg MCI-186 to ALS patients.~   "
239181|NCT00424450|"~     Contrast ultrasound perfusion imaging (CUPI) is a novel tool for the assessment of muscle~     perfusion deficits in peripheral arterial disease (PAD). In this study we want to examine the~     effect of bypass surgery and balloon angioplasty on the calf muscle blood supply. We hope~     find a new way of quantifying success or failure of invasive treatment strategies.~   "
239182|NCT00424437|"~     To determine, in subjects with Type 1 Diabetes Mellitus:~        1. Whether glycemic control can be achieved at least as effectively with an insulin regimen~          involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a~          conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin~          injections per day.~        2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if~          any, on measures of pulmonary function.~   "
239183|NCT00424424|"~     This study is being conducted to evaluate the safety and tolerability of the drug and to~     evaluate its efficacy compared to placebo and to ibuprofen in the prevention of postoperative~     dental pain in male patients.~      This is an early phase trial and some specific protocol information is proprietary and not~     publicly available at this time. (Full information is available to trial participants).~   "
239184|NCT00424411|"~     To determine, in subjects with Type 2 Diabetes Mellitus:~        1. Whether glycemic control can be achieved at least as effectively with an insulin regimen~          involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection~          as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH~          insulin injections per day.~        2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6~          months, if any, on measures of pulmonary function.~   "
239185|NCT00424398|"~     The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is~     effective in the treatment of acute allergic conjunctivitis~   "
239186|NCT00424385|"~     Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3~     patients to be on study. Patients will receive both study drugs on escalated dosing schedule~     until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. Once~     the pre-specified 400 mg by mouth two times a day (PO BID) dosing for both drugs is reached~     without toxicity, the study will close for accrual. If toxicity is noted prior to reaching~     the 400 mg PO BID dosing, then the dosing schedule that is deemed safest as per study design~     will be the one used for any future phase II study.~   "
239187|NCT00424372|"~     To evaluate the safety of the long-term use of pregabalin.~   "
239188|NCT00424359|"~     This is a study comparing clinical tests of walking and balance. The goal of this study is to~     discover which of those tests are best at predicting walking problems due to MS.~   "
239189|NCT00424346|"~     The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose~     regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to~     7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The~     study investigated the magnitude of effect as well as onset of effect for the different dose~     regimens.~      The primary objective of the extension studies was to assess long-term safety and~     tolerability of canakinumab (ACZ885) in patients with active RA. CACZ885A2201E1 evaluated~     this objective in patients who had participated in the core study (CACZ885A2201) and~     CACZ885A2201E2 did the same in patients who completed the first extension study.~   "
239190|NCT00424333|"~     To determine in subjects with Type 1 Diabetes Mellitus:~        1. Whether glycemic control can be achieved at least as effectively with a) an intensive~          insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH~          insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular~          insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens~          differ only by the route of delivery of the short acting insulin.~        2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if~          any, on measures of pulmonary function.~   "
239191|NCT00424320|"~     The purpose of this study is to determine whether sodium bicarbonate is effective in the~     prevention of sodium-induced nephropathy~   "
239192|NCT00424307|"~     The primary purpose of this study is to track patient outcomes for bilateral cochlear implant~     recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive~     two implants in the same operation or in two different surgeries with the initial fitting of~     the devices separated by no more than six months.~   "
239193|NCT00424294|"~     To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in~     subjects with rheumatoid arthritis~   "
239561|NCT00419432|"~     The purpose of this pilot trial is to determine whether the addition of gait laboratory~     analysis for surgical decision making, compared with the use of observational analysis alone,~     results in improved functional outcomes in ambulatory children with cerebral palsy undergoing~     multi-level lower extremity orthopaedic surgery.~   "
239194|NCT00424281|"~     Patients in intensive care units have higher risks for developing blood clots. Arixtra~     inhibits blood clot formation by binding with the blood clotting factor, Xa. Critical~     illnesses and, specifically, medications given in the ICU to increase arterial blood pressure~     (vasopressors) may impair the absorption of drugs like Arixtra that are given subcutaneously.~     The study will measure the levels of Arixtra in blood comparing those subjects who are and~     those subjects who are not on blood pressure medication.~   "
239195|NCT00424268|"~     The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary~     function and symptomatic parameters in patients with chronic obstructive pulmonary disease~     (COPD) during concomitant administration of tiotropium. The study duration will last up to 28~     weeks. The study will provide further data on safety and tolerability of roflumilast.~   "
239196|NCT00424255|"~     This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial~     comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with~     head and neck cancer following surgery. Lapatinib or placebo will be administered~     post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib~     or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing~     the recurrence of the disease in these high-risk patients.~   "
239197|NCT00424242|"~     RATIONALE: Pemetrexed disodium may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Studying samples of cerebrospinal fluid and blood from~     patients with cancer in the laboratory may help doctors learn how pemetrexed disodium works~     in the body and identify biomarkers related to cancer.~      PURPOSE: This clinical trial is studying the side effects and how well pemetrexed disodium~     works in treating patients with leptomeningeal metastases.~   "
239198|NCT00424229|"~     We are evaluating the incidence of significant hematological response, according to IWG~     criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of~     patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System~     [IPSS]) MDS with a deletion (del) 5q[31]~   "
239199|NCT00424216|"~     This study will explore what effects, if any, direct current (DC) brain polarization may~     produce on mental processes, such as attention, reaction time, working memory, speed of~     information processing and mood or emotional states. In DC brain polarization, a very weak~     electrical current is applied to the head. This technique has been used for many years on~     patients and healthy people with no known serious side effects. Studies have shown that DC~     polarization can temporarily improve people's ability to think of certain words. To determine~     if DC polarization can be used as a treatment for certain types of brain disorders, its~     possible effects on mood and other mental abilities must be determined.~      Healthy normal volunteers over age 18 may be eligible for this study.~      In each of three 1.5-hour sessions scheduled a day apart, participants complete the tasks~     listed below to determine the effects of polarization. For each session, electrodes are~     placed on the head, arm, and hand. One set of electrodes is for brain stimulation; the second~     set is used to measure the amount of skin moisture on the hand. The participants' tasks are~     to:~        -  Push a button on a keyboard when they see a specific item.~        -  Circle a number or make a mark on a line to indicate how much they feel a particular~          emotion or sensation at that time.~        -  Answer questions about themselves, or their opinions on certain topics.~        -  Look at several pictures and say how emotional they think they are.~        -  Read about an imaginary situation and say what they would do in that situation.~        -  Choose between decks of cards to try to win money.~        -  Compare the angles of lines.~        -  Identify smells, using a scratch and sniff test.~        -  At the end of the session, say how they are feeling.~      Participants are called by phone on the day after each session to see how they are feeling.~   "
239200|NCT00424203|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells~     that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving doxorubicin together with~     cyclophosphamide works in treating older women with stage I , stage II, or stage III breast~     cancer that has been removed by surgery.~   "
239201|NCT00424190|"~     The purpose of this study is to determine whether ceftaroline is effective and safe in the~     treatment of complicated skin infections in adults.~   "
239202|NCT00424177|"~     This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and~     tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study~     will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the~     pharmacodynamics and durability of eltrombopag response as measured by the peripheral~     platelet counts.~      For more information or to see if you qualify, please visit: http://www.itpstudy.com/gov~   "
239203|NCT00424164|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy~     using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells.~     Giving lapatinib together with tamoxifen may be an effective treatment for breast cancer.~      PURPOSE: This randomized phase I trial is studying the side effects of lapatinib and~     tamoxifen in treating patients with advanced or metastatic breast cancer.~   "
239204|NCT00424151|"~     This study is designed to treat patients with Graves' disease with Rituximab in an attempt to~     prevent or reverse the physically deforming and debilitating consequences of this disease.~   "
239205|NCT00424138|"~     RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 (^18FDG) positron emission~     tomography (PET)/CT scans, may help doctors predict a patient's response to treatment and~     help plan the best treatment.~      PURPOSE: This clinical trial is studying ^18FDG PET/CT scans to see how well they predict~     response in patients undergoing chemotherapy for stage IIIB or stage IV non-small cell lung~     cancer.~   "
239206|NCT00424125|"~     This study seeks to determine whether education provided in community pharmacies and monthly~     reminder calls can improve compliance with asthma medications.~      We hypothesize that those pediatric patients with asthma 12 months to 12 years of age who~     receive comprehensive asthma care as part of a validated intervention (1) who are randomized~     to receive enhanced community pharmacy care will have significantly greater compliance with~     inhaled corticosteroids (ICS) six months after enrollment when compared with patients~     receiving usual pharmacy care. As secondary outcomes, we further hypothesize that they will~     have less unscheduled healthcare utilization and improved functional outcomes and QOL.~      (1) Teach SJ, Crain EF, Quint DM, Hylan ML, Joseph JG. Improved Asthma Outcomes in a High~     Morbidity Pediatric Population: Results of an Emergency Department-based Randomized Clinical~     Trial. Archives of Pediatric and Adolescent Medicine. 2006;160:535-541.~   "
239562|NCT00419419|"~     The purpose of this research study is to test the safety, tolerability, and effectiveness of~     Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase~     blood flow to the fingers.~   "
239207|NCT00424112|"~     The purpose of this study is to determine if and to what extend a composite measure of~     treatment motivation and behavior change motivation predicts alcohol treatment success. It is~     expected that the composite measure based on the stages of the Transtheoretical Model of~     Behavior Change is a better predictor for treatment outcome than treatment motivation or~     behavior change motivation alone. Participants will be recruited from alcohol treatment~     centers. A baseline interview regarding their motivation, drinking behavior and personal~     treatment goals will be conducted. At the end of treatment, treatment staff will be asked~     about treatment involvement of each participant. Two follow-up interviews will be conducted~     after 6 and 12 months. To identify the impact of behavior change and treatment motivation on~     change in drinking behavior, data will be pooled with a non-treatment seeking sample.~     Conclusions can be drawn on what motivation pattern best predicts behavior change for those~     utilizing formal help and for those remitting without formal help (self-changers).~   "
239208|NCT00424099|"~     The goal of this clinical research study is to learn if methylphenidate (Ritalin) can help to~     control fatigue caused by cancer. Its effect on other symptoms such as drowsiness,~     depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal~     of this study is to learn if receiving a phone call by a nurse improves fatigue in patients.~   "
239209|NCT00424086|"~     The objective of this study is to assess the safety, tolerability and immunogenicity of a~     Split Virus, Vero Cell derived, Seasonal Influenza Vaccine (VCIV) in comparison to a Licensed~     Egg Derived, Split Virus, Seasonal Influenza Vaccine (EIV) in healthy subjects 18 years of~     age and older.~      Approximately 1000 subjects will be randomly assigned in a 3:1 ratio to receive a single~     injection of VCIV or EIV. Subjects will be monitored for 180 days following vaccination for~     occurrence of adverse reactions and for antibody response to the vaccine.~   "
239210|NCT00424060|"~     RATIONALE: Drugs used in chemotherapy, such as epothilone ZK-219477, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~      PURPOSE: This phase II trial is studying how well epothilone ZK-219477 works in treating~     patients with recurrent glioblastoma.~   "
239211|NCT00424047|"~     To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose~     dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for~     subjects with relapsed or refractory multiple myeloma.~   "
239212|NCT00424034|"~     To investigate the safety, tolerability, pharmacokinetics and the effect of food on~     pharmacokinetics after single oral administrations of GSK1325760A~   "
239213|NCT00424021|"~     AMB-220-E is an international, multicenter, open-label study examining the long-term safety~     of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study~     NCT00046319, A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging,~     Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to~     Severe Pulmonary Arterial Hypertension.~   "
239214|NCT00424008|"~     This study is being conducted to demonstrate the non-inferiority between two inhaled~     glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone~     furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone~     propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the~     onset of action, the overall safety, and how the drugs control asthma will also be assessed.~     The study is approximately 1 year in duration.~   "
239215|NCT00423995|"~     This is study of LMC, phenylephrine, and placebo in subjects with SAR. There are three~     visits: At Visit 1, subjects will be evaluated for participation and, if they qualify, will~     attend Visit 2 for priming. At Visit 2, ragweed pollen will be fed continuously and dispensed~     into the environmental exposure unit to induce an allergic reaction. Pollen counts will be~     monitored and recorded. During the priming visit(s), subjects will be evaluated to determine~     if they qualify. If qualified, they will return for Visit 3, where ragweed pollen will be fed~     continuously and dispensed into the environmental exposure unit to induce an allergic~     reaction. Pollen counts will be monitored and recorded as in the Priming Session. Subjects~     will complete symptom evaluations and if qualified, they will receive study medication and~     remain in the environmental exposure unit where symptoms will be evaluated for 8 hours after~     dosing. PNIF will be evaluated only during the treatment session. Four nasal symptoms~     (rhinorrhea, nasal congestion, sneezing, and nasal itching) and three non-nasal symptoms~     (itching/burning eyes, tearing/watery eyes, and itching of ears/palate) will be evaluated.~     Adverse events will be collected throughout the study to assess safety and tolerability, and~     vital signs will be collected at Visit 1 and at the end of Visit 3.~   "
239216|NCT00423982|"~     The number of patients requiring joint replacement is increasing due to its success in~     restoring function and pain relief, and the growing population of the elderly. One of the~     most serious complications of arthroplasty is joint prosthesis infection. Due to the absence~     of prospective, randomized, controlled studies, there is no consensus concerning diagnosis~     and treatment of prosthetic joint infections. The main objective of this trial is to evaluate~     the clinical efficacy of rifampin combination therapy versus monotherapy using cloxacillin or~     vancomycin in early staphylococcal infections after total hip and knee arthroplasty.~   "
239217|NCT00423969|"~     The purpose of this study is to investigate whether the addition of galantamine to a commonly~     used antidepressant, escitalopram (Lexapro), will be useful in the treatment of memory and~     other thinking problems that are frequently seen in depression. At present, galantamine is~     approved for use in the treatment of Alzheimer’s disease or dementia, but not for use for the~     treatment of depression in younger patients.~      Possible genetic effects of depressed individuals will also be studied. This study is~     involved in collecting blood from patients with depression. DNA, the genetic material in our~     cells, will be obtained from these blood samples. The DNA will be studied to determine the~     contribution of different genes to the development of depression. These blood samples are~     extremely useful to researchers who are trying to determine the genetic risk factors that may~     lead to depression.~   "
239251|NCT00423527|"~     Multiple sclerosis is often associated with pain. There is no standard treatment of this type~     of pain. Levetiracetam is a new anticonvulsant and it is the hypothesis that it could relieve~     central pain in multiple sclerosis. This is a randomised, double-blind, placebo-controlled,~     cross-over trial on the effect of levetiracetam 3000 mg daily on pain in multiple sclerosis.~   "
239218|NCT00423956|"~     Tooth-root resorption, also known as shortening or erosion,(TRR) is one of the adverse~     outcomes of dental trauma, orthodontic tooth movement and dental~     replantation/transplantation. Orthodontically induced inflammatory root resorption (OIIRR) is~     somewhat different from other types of TRR. The treatment protocol of teeth diagnosed with~     severe OIIRR or other forms of TRR always involves root canal treatment or extraction of~     these teeth in severe cases and prosthetic replacement. Sometimes teeth with minor TRR may~     stay for an extended period of time with compromised bite functions. Although several trials~     have been proposed to minimize or prevent TRR or OIIRR, none is capable of being used in~     clinical situation to treat TRR or OIIRR in humans except for Low Intensity Pulsed Ultrasound~     (LIPUS). However, research examining the use of LIPUS to treat OIIRR has been limited to~     simple orthodontic tooth tipping. In reality, tooth movement is a combination of different~     types of tooth movements, namely tipping, bodily, rotational, torque, intrusion and extrusion~     tooth movements. However, the literature have pointed out that torque tooth movement,~     especially when the root apices are torques against cortical plates of bone produces the most~     dramatic type of tooth root resorption with poor prognosis. Our long-term goal is to develop~     a standard protocol for treating severe tooth root resorption with poor prognosis in humans,~     regardless of origin. Our preliminary data demonstrates that LIPUS can produce healing of~     OIIRR in humans after simple tipping movement, this was confirmed by an in-vitro study on~     isolated cementoblasts. The objective of the present proposal is to evaluate the effect of~     different treatment protocols of LIPUS on the healing process of orthodontically induced~     tooth-root resorption due to torque (Complex)type of tooth movement in humans.~      The study Hypotheses are (I) LIPUS treatment for 20 minutes per day for 4 weeks will be~     effective in repairing OIIRR due to torque tooth movement.~      (II) The stimulatory effect of LIPUS to repair OIIRR due to torque tooth movement than LIPUS~     treatment is dose and time dependent.~   "
239219|NCT00423943|"~     Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This~     appears to be responsible for their difficulties in social and occupational functioning. One~     particular cognitive function that may be important for schizophrenia is called context~     processing. This refers to the ability to properly use information in the environment to~     guide thinking and behavior so that it is appropriate to the present circumstance. Problems~     with this function may explain why patients with schizophrenia think and act in unusual ways,~     and often have problems managing aspects of their lives that healthy adults take for granted.~     This cognitive function depends on a region of the brain called the prefrontal cortex, which~     shows impaired function in schizophrenia as well. Unfortunately, the biochemical aspects of~     this dysfunction are presently unknown, and it is not clear whether current psychiatric~     medications can improve this function. A recent FDA-approved medication that may improve this~     function is modafinil. Studies in animals and healthy adults show that this medication can~     improve cognitive functions which are related to context processing. We plan to study the~     effects of modafinil on context processing and the brain activity that underlies this~     function. We will use functional MRI and electrophysiology to examine the effects of~     modafinil, both after a single dose and after sustained (4 week) treatment. We predict that~     when patients receive modafinil they will perform better on cognitive tests and have improved~     activity in the regions of the brain that are responsible for these cognitive processes.~   "
239220|NCT00423930|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of head~     and neck cancer by blocking blood flow to the tumor. Specialized radiation therapy that~     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause~     less damage to normal tissue. Giving cisplatin and bevacizumab together with~     intensity-modulated radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving cisplatin and~     bevacizumab together with intensity-modulated radiation therapy works in treating patients~     with stage III or stage IV head and neck cancer.~   "
239221|NCT00423917|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Fulvestrant and bevacizumab may also stop the~     growth of breast cancer by blocking blood flow to the tumor. Giving fulvestrant together with~     bevacizumab may be an effective treatment for metastatic breast cancer.~      PURPOSE: This phase II trial is studying how well giving fulvestrant together with~     bevacizumab works in treating patients with metastatic breast cancer.~   "
239222|NCT00423904|"~     The purpose of the study is to reveal the most promising procedure for implementing alcohol~     screening and intervention in general hospitals and to find out, if and to which extent~     non-specialist health professionals can be qualified to carry out motivational intervention~     on their own or if there is a need for a specialized counseling services. In a randomized~     controlled trial, patients recruited in general hospitals and fulfilling criteria for alcohol~     dependence, alcohol abuse, at-risk drinking or heavy episodic drinking will be allocated to~     three conditions: (1) Intervention by a liaison service (LC): Counselling based on the~     Transtheoretical Model of behaviour change (TTM) which will be provided by staff of the study~     (psychologists/ social worker) trained in Motivational Interviewing (MI), (2) Intervention by~     hospital physicians (PC): Counselling will be provided by hospital physicians trained in MI,~     and (3) Control group (CC): Treatment as usual, assessment only. Outcome assessment will be~     conducted after 12 months and includes abstinent point prevalence rates, drinks per day,~     help-seeking, stage progress and cost-effectiveness analysis.~   "
239223|NCT00423891|"~     The purpose of this clinical study is to determine the appropriate doses of entecavir to use~     in children and adolescents. Safety, tolerability and efficacy will also be studied~   "
239224|NCT00423878|"~     The study will compare the effectiveness of antipsychotic medications for patients with~     schizophrenia or schizoaffective disorder for whom a medication change may be indicated~     because of an increased risk of cardiovascular disease.~   "
239225|NCT00423865|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Everolimus may also help cisplatin work better by making tumor cells more sensitive~     to the drug. Giving cisplatin together with everolimus may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with cisplatin in treating patients with advanced solid tumors or recurrent or~     metastatic solid tumors.~   "
239927|NCT00414596|"~     This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000~     for active treatment of chronic low back pain.~   "
239226|NCT00423852|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. An autologous peripheral stem cell transplant may be able to replace~     blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to~     be given so that more tumor cells are killed.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when~     given together with paclitaxel and carboplatin followed by an autologous stem cell transplant~     and to see how well they work in treating patients with germ cell tumors that did not respond~     to cisplatin.~   "
239227|NCT00423839|"~     A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers~   "
239228|NCT00423826|"~     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor~     umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells.~     It also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune cells and help destroy any remaining cancer or~     abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving tacrolimus and~     mycophenolate mofetil before the transplant may stop this from happening.~      PURPOSE: This clinical trial is studying how well umbilical cord blood stem cell transplant~     works in treating patients with hematologic cancer or other disease.~   "
239229|NCT00423813|"~     The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to~     placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled,~     parallel group trial.~   "
239230|NCT00423800|"~     This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48~     weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve~     Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C~     Virus-Ribonucleic Acid (HCV-RNA) negative at Week 4. HVL will be defined as HCV-RNA of~     >600,000 IU/mL prior to the initiation of therapy. Participants with genotype 1 baseline HVL~     prescribed Pegetron® (peginterferon and ribavirin) in the usual manner in accordance with the~     marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to~     receive a total of 24 or 48 weeks of therapy. Participants will be required to have their~     baseline and Week-12 viral load analyzed by the same local laboratory using the standard of~     care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be~     conducted either by local laboratory or a central laboratory identified by the sponsor using~     an assay specified by the sponsor. No additional interventions outside of the clinic's~     standard of care and the conditions of the Canadian product monograph for Pegetron® will be~     applied to participants.~   "
239231|NCT00423787|"~     Ragweed MATAMPL has been developed by Allergy Therapeutics to provide pre-seasonal specific~     immunotherapy for patients with proven type I hypersensitivity to cross reacting ragweed~     pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma~     bronchiale. The purpose of this study is to compare the efficacy of Ragweed MATAMPL versus~     placebo in ragweed-allergic subjects following 4 subcutaneous injections of study medication~     administered before the start of the 2007 ragweed pollen season~   "
239232|NCT00423774|"~     his study will evaluate a series of problem-solving education sessions for patients~     undergoing a stem cell transplant and their family caregivers. The emotional stress of~     transplant extends beyond patients to their families, especially caregivers. Little is known~     about managing the emotional distress associated with stem cell transplant or the support and~     education most helpful to caregivers of stem cell recipients.~      Patients undergoing a stem cell transplant and their family caregivers may be eligible for~     this study. All participants must be 18 years of age and older.~      Patients and their caregivers receive routine treatment-specific education from transplant~     team members. This study adds a series of educational sessions focusing on problem-solving~     skills. In addition to the study education, participants do the following:~        -  Complete a 130-item questionnaire when they consent to participate in the study.~        -  Complete a 60-item questionnaire and attend a 60-minute face-to-face education session~          before the transplant.~        -  Complete a 40-item questionnaire and attend a 60-minute face-to-face education session~          before hospital discharge.~        -  Complete the same 40-item questionnaire and attend a 60-minute face-to-face education~          session 2 weeks after hospital discharge.~        -  Attend a 30-minute face-to-face education session 4 weeks after hospital discharge.~        -  Complete a 60-item questionnaire 6 weeks after hospital discharge.~   "
239233|NCT00423761|"~     This study will evaluate any effect of single and repeated administration of GW876008 on the~     metabolism of midazolam in healthy volunteers.~   "
239234|NCT00423748|"~     A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy~     of ambrisentan in subjects with pulmonary arterial hypertension.~   "
239235|NCT00423735|"~     This phase II trial studies how well dasatinib works in treating patients with glioblastoma~     multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
239236|NCT00423722|"~     The goal of this clinical research study is to learn whether being hydrated (given liquids)~     through a catheter in a vein or in the tissue under the skin can improve symptoms of~     dehydration.~      Objectives:~      1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms~     associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in~     advanced cancer patients receiving hospice care.~      1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or~     reducing the severity of delirium in patients with advanced cancer receiving hospice care.~      1.3 Describe the meaning patients and primary caregivers attribute to dehydration and~     re-hydration at the end of patient's lives.~   "
239237|NCT00423709|"~     1. To determine the feasibility and toxicity of employing allogeneic peripheral blood stem~          cell transplantation after intensive but non-myeloablative chemotherapy in patients with~          relapsed Hodgkin's disease (HD).~        2. To determine the engraftment kinetics and degree of chimerism that can be achieved with~          this strategy.~        3. To assess the antitumor activity of this approach in high-risk HD patients and the~          possible presence of a graft-vs-HD effect.~   "
239238|NCT00423696|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving bevacizumab together with combination chemotherapy may~     kill more tumor cells. It is not yet known which combination chemotherapy regimen is more~     effective when given together with bevacizumab in treating patients with colorectal cancer.~      PURPOSE: This randomized phase II trial is studying bevacizumab to compare how well it works~     when given together with two different combination chemotherapy regimens as first-line~     therapy in treating patients with metastatic colorectal cancer that cannot be removed by~     surgery.~   "
239239|NCT00423683|"~     The development of clots is a potentially deadly complication in many cancer patients. The~     current optimal treatment is unknown. Evidence supporting the effectiveness of the use of~     Inferior Vena Caval Filters is lacking. This study will compare the two standard of care~     treatment options: anticoagulation with or without a inferior vena cava filter. The~     anticoagulation medication chosen will be Arixtra and it will be given once a day as an~     injection. Patients will be called at various intervals to monitor their signs and symptoms~     of new thromboembolisms.~   "
239240|NCT00423670|"~     This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve~     Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2~     parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800~     to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034)~     800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus~     standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG)~     and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000~     mg/day) plus boceprevir for 48 weeks.~   "
239241|NCT00423657|"~     The purpose of this study is to determine whether ceftaroline is effective and safe in the~     treatment of complicated skin infections in adults.~   "
239242|NCT00423644|"~     The study of safety of a new organic arsenic compound in the treatment of advanced multiple~     myeloma~   "
239243|NCT00423631|"~     Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered~     a chronic condition and is most commonly treated or managed using medications. Previous~     studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication~     intervention, to standard care in order to obtain better outcomes in terms of improved~     functional status and symptom reduction. While the addition of CBT to standard care has been~     shown to be beneficial, it is not a form of therapy that is widely available to patients with~     FMS. CBT includes a variety of skills that can be taught to patients to help in the~     management of chronic illnesses. This protocol will examine the relative merits of providing~     these CBT skills to patients via an informational website. The website will contain the~     content of CBT, a social support capability, and data transfer capabilities. The addition of~     this website to standard care will be compared to standard care alone. This study is~     interested in assessing improvements in physical functional status, the symptoms of FMS, and~     the relative costs of the interventions as compared to the savings in health care utilization~     over a 6-month period.~      Primary Hypothesis The primary hypothesis of this study is that the number of patients with~     fibromyalgia who are able to achieve clinically meaningful improvements in physical function~     will be greater when standard symptom-based pharmacological care is augmented by CBT skills~     delivered through an educational website.~      Secondary Hypotheses~        1. The proportion of patients with fibromyalgia who are able to achieve clinically~          meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived~          cognitive difficulties will be greater when standard symptom-based pharmacological care~          is augmented by CBT skills delivered through an educational website~        2. The proportion of patients with fibromyalgia who are able to achieve clinically~          meaningful improvements in mood and beliefs about pain will be greater when standard~          symptom-based pharmacological care is augmented by CBT skills delivered through an~          educational website~   "
239244|NCT00423618|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known~     whether giving radiation therapy to a smaller area of tissue surrounding the tumor is as~     effective as giving radiation therapy to a wider area of tissue surrounding the tumor in~     treating soft tissue sarcoma.~      PURPOSE: This randomized phase III trial is studying giving external-beam radiation therapy~     to a small area of tissue surrounding the tumor to see how well it works compared with giving~     external-beam radiation therapy to a wider area of tissue surrounding the tumor in treating~     patients who have undergone surgery for soft tissue sarcoma of the arms, hands, legs, or~     feet.~   "
239245|NCT00423605|"~     The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term~     use.~   "
239246|NCT00423592|"~     This Phase 2 study was to determine the incidence of increased serum aminotransferase~     concentrations (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]), as~     well as the overall safety and tolerability of ambrisentan, in participants with pulmonary~     arterial hypertension (PAH), idiopathic PAH (IPAH), or familial PAH (FPAH) who had previously~     discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST~     concentrations.~   "
239247|NCT00423579|"~     This study is being conducted to compare the efficacy, safety, and tolerability of~     ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of~     simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.~   "
239248|NCT00423566|"~     This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia~     Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis). This vaccine is~     delivered intrdermally by a needle injection in healthy volunteers.~   "
239249|NCT00423553|"~     This study will collect heart tissue that is routinely removed and discarded during~     open-heart surgery. The Cardiology Branch of the NHLBI is conducting a variety of laboratory~     experiments that require a sample of heart tissue. A segment of tissue is routinely cut out~     of the right atrial appendage of the heart during open-heart surgery to allow the heart-lung~     bypass machine to be attached to the heart for protection during surgery. This small tissue~     sample is not re-attached after the bypass machine is removed, but usually destroyed as~     medical waste.'~      People between 18 and 80 years of age who are scheduled to undergo coronary artery bypass~     surgery or aortic valve replacement surgery may be eligible for this study.~      Participants donate the right atrial appendage of the heart, which would normally be~     destroyed after their open-heart surgery. The tissue will be used by NHLBI investigators in~     studies directed at learning how to make the heart less sensitive to damage from a heart~     attack. The samples may be used, for example, to evaluate the effectiveness of known~     therapies, refine treatment approaches, identify potential new therapies, or explore~     opportunities for disease prevention.~   "
239250|NCT00423540|"~     This study sets out to show whether infusions of magnesium can lessen the frequency of rest~     cramps and to determine whether rest cramp sufferers have a deficiency in magnesium.~   "
239252|NCT00423514|"~     RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor~     stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop~     the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     tacrolimus and mycophenolate mofetil before the transplant may stop this from happening.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when~     given together with melphalan and thiotepa, followed by a donor stem cell transplant and to~     see how well it works in treating patients with high-risk and/or advanced hematologic cancer~     or other disease.~   "
239253|NCT00423501|"~     This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of~     multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are~     treated with a stable dose of metformin. Patients will be randomized to receive either~     subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or~     20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen~     throughout the study. The anticipated time on study treatment is <3 months, and the target~     sample size is 100-500 individuals.~   "
239254|NCT00423488|"~     This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6~     weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be~     more effective than treatment with doubling the dose of simvastatin to 40 mg alone in~     reducing low-density lipoprotein-cholesterol (LDL-C) concentrations and in achieving the~     National Cholesterol Expert Panel (NCEP) III LDL-C target goal of <2.6 mmol/L (<100 mg/dL)~     for subjects with diabetes mellitus and coronary heart disease.~   "
239255|NCT00423475|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause~     the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the~     adrenal glands from making androgens. Giving radiation therapy with or without goserelin~     after surgery may kill any tumor cells that remain after surgery. It is not yet known whether~     radiation therapy is more effective with or without goserelin in treating prostate cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see~     how well they work compared with radiation therapy alone in treating patients who have~     undergone surgery for recurrent or refractory prostate cancer.~   "
239256|NCT00423462|"~     Analysis of the ongoing patient-therapist interaction, the transference, is considered a key~     active ingredient in psychoanalytically oriented psychotherapy and psychoanalysis.However,~     one century after Sigmund Freuds's famous Dora case, the first clinical description of~     transference, no study of transference interpretations have been published.In the present~     study 100 out-patients were randomized to receive one year weekly dynamic psychotherapy, with~     and without transference interpretations. That is, one treatment component,transference~     interpretations, were added to a comparison condition, therapy of the same format, by the~     same therapists, but without use of transference interpretation.~      All treatment session were audiotaped, and treatment integrity have been carefully checked.~     Patients were evaluated at treatment termination, one year after treatment termination and~     three years after treatment termination. Enrollment of patients started january 1993, and all~     follow-up evaluations completed by December 2005.~   "
239257|NCT00423449|"~     This is a clinical trial to determine the safety and tolerability of MK0683 in combination~     with gemcitabine and cisplatin and/or carboplatin.~   "
239258|NCT00423436|"~     Primary Objectives:~        -  To compare the effectiveness of an interactive voice response (IVR) telephone~          triage/feedback system versus an interactive voice response telephone system with~          assessment only in monitoring and managing symptoms in patients with advanced non small~          cell lung cancer (NSCLC).~        -  To compare differences in mood and quality of life variables of patients using the IVR~          triage/feedback system versus IVR assessment only.~        -  To compare the healthcare utilization (emergency visits, admissions, length of stay for~          hospitalizations for uncontrolled symptoms) of patients using the IVR triage/feedback~          system versus IVR assessment only.~   "
239259|NCT00423410|"~     This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic effects of a~     novel anti-cancer drug, EPC2407, administered to patients with advanced cancer which have not~     responded to or have recurred following treatment with available therapies~   "
239260|NCT00423397|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. PEG-interferon alfa-2a may interfere with the growth of tumor cells~     and slow the growth of skin cancer. Giving gefitinib together with PEG-interferon alfa-2a may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of PEG-interferon~     alfa-2a when given together with gefitinib and to see how well they work in treating patients~     with unresectable or metastatic skin cancer.~   "
239261|NCT00423384|"~     Loss of bone mass is a common complication in patients with end-stage-renal failure, both~     before and particularly after transplantation. In addition to standard underlying therapy~     with calcium and active vitamin D, we will study the effect of ibandronate (a bisphosphonate)~     versus placebo on bone mineral density as well as incidence of fracture rates after kidney~     transplantation.We also wish to study whether any prevented bone loss will also lead to~     reduced cardiovascular disease. Patients will be followed for 12 months after~     transplantation, and the ibandronate treatment is one injection every 3 months.~   "
239262|NCT00423371|"~     This multicenter, double-blind, randomized, parallel-group, active-controlled trial will be~     performed in approximately 80 subjects with chronic idiopathic osteoarthritis (OA) of the~     first carpo-metacarpal joint (CMC).~   "
239263|NCT00423358|"~     This study recruits individuals with rheumatoid arthritis (RA) and low vitamin D~     concentrations. Subjects are dosed with vitamin D or placebo for one year. Primary outcome is~     change in bone turnover markers, additionally, bone mineral density and parameters of RA~     status are evaluated throughout the study.~   "
239299|NCT00422890|"~     Efficacy and safety of 5-Azacytidin in the treatment of the haematological relapse in~     patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling~     CD34-chimerism after hematopoietic stem cell transplantation.~   "
239264|NCT00423345|"~     Registration of patients referred for colon investigation by barium enema, CT colonography~     and colonoscopy in two hospitals and one radiology centre in Telemark, Norway, for a period~     of minimum six months. Indications, delay and results of procedure will be~     recorded.Hypothesis: Choice of procedure for colon investigation is not based solely on~     clinical indication, but factors like delay, patient preference, lack of knowledge about the~     the procedures by the referring physician may have a decisive influence. The study will also~     analyse the correlation between patients symptoms, clinical findings and laboratory results~     and major pathology findings by colon investigation. Further, delay from patient´s first~     symptoms to finally diagnosis by colon investigation will also be registered and analysed.~   "
239265|NCT00423332|"~     Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours~     and also how well it is tolerated.~   "
239266|NCT00423319|"~     The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg~     (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip~     replacement surgery and to learn how apixaban compares with enoxaparin in preventing these~     clots. The safety of apixaban will also be studied~   "
239267|NCT00423306|"~     The study of safety of a new organic arsenic compound in the treatment of advanced~     hepatocellular carcinoma~   "
239268|NCT00423293|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in~     chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving~     intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in~     treating patients with invasive anal cancer.~   "
239269|NCT00423280|"~     The purpose of this study is to determine the effect of 6R-BH4 on vascular function in~     patients with coronary artery disease. We hypothesize that 6R-BH4 will improve vascular~     function in these patients.~   "
239270|NCT00423267|"~     To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A~     consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and~     participants in Period A may have been eligible to roll over to an open-label,~     non-comparitive Period B. During Period B, participants received posaconazole for a treatment~     duration not to exceed 12 months.~   "
239271|NCT00423254|"~     The present clinical trial is a dose comparison of a multi-component active immunotherapy~     designed to stimulate an immune reaction to specific tumor associated antigens which are~     highly expressed on a large number of solid cancers.~   "
239272|NCT00423241|"~     This study will compare the clinical performance of the SEMPERFLO* Pain Management System~     with another commercial pain relief system using 0.5% bupivacaine following unilateral, open,~     inguinal hernia repair procedures.~      *Trademark~   "
239273|NCT00423228|"~     Alzheimer's disease is characterised by memory loss and difficulties with thinking. These~     problems may be due to a deficiency in a brain chemical called acetylcholine. Acetylcholine~     helps transmit messages between nerve cells. Acetylcholine is degraded by an enzyme called~     acetylcholinesterase. ZT-1 is a new drug derived from a plant extract already used in China~     for memory disorders, which blocks the action of the enzyme and restores adequate levels of~     acetylcholine.~      This study will test the safety and efficacy of ZT-1 in the treatment of patients with~     Alzheimer's disease.~      BRAINz stands for Better Recollection for Alzheimer's patients with the Implant of ZT-1.~   "
239274|NCT00423215|"~     The objective of this protocol is to confirm the efficacy and safety profile of Lantus in~     every day medical practice, in type 2 diabetic patients, have been treated with any other~     insulin but who did not reach the target of A1c = 7%.~   "
239275|NCT00423202|"~     A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy~     of ambrisentan in subjects with pulmonary arterial hypertension.~   "
239276|NCT00423189|"~     The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination~     therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with~     exudative AMD.~   "
239277|NCT00423176|"~     The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone~     furoate nasal spray), when used together with an antibiotic, for the relief of symptoms~     associated with acute bacterial sinusitis. Efficacy will be based on both subjective~     (assessment of symptom severity by the patient) and objective measurements (computed~     tomography [CT] imaging of the sinuses).~   "
239278|NCT00423163|"~     To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole~     alone as primary therapy for invasive aspergillosis.~   "
239279|NCT00423150|"~     This study is proposed to evaluate the efficacy and safety of temozolomide, an oral~     anti-cancer agent, in a participant population selected for a biomarker. Participants with~     colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer~     will be included.~   "
239280|NCT00423137|"~     Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis~   "
239281|NCT00423124|"~     The aim of the study is to obtain immune reconsitutuion as well as reduction of infective~     episodes and disease relapse in patient with haematological malignancies who underwent~     SCT(and subsequent T lymphocytes infusions) and selectively controlling GvHD.~   "
239282|NCT00423111|"~     The purpose of this study is to determine whether there is a correlation between cognitive~     functions and volume of specific brain area measured in MRI of multiple sclerosis patients.~   "
239283|NCT00423098|"~     The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in~     combination with two different corticosteroid (CS) regimes for the induction of remission of~     a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I)~     or to a reduced dose CS regimen (group II)~   "
239284|NCT00423085|"~     The purpose of this study was to investigate the 5cm^2 and 10cm^2 doses of rivastigmine~     transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's~     Disease (MMSE [Mini Mental State Examination] 10-20). A 52-week extension phase evaluated the~     safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients~     with probable Alzheimer's Disease (AD).~   "
239285|NCT00423072|"~     The investigators know that middle-ear disease is very common in infants with cleft palate~     and causes hearing loss that can last into childhood. It is thought that a poor ability to~     keep the pressure in the middle ear at a similar level to that in the environment causes~     middle-ear disease and that this depends on the opening function of a natural tube that~     connects the back of the nose with the middle ear, called the Eustachian tube. The~     investigators believe that the middle-ear disease in cleft palate infants and children is~     caused by poor Eustachian tube function that in turn is caused by anatomical problems in the~     muscles that open the tube. The investigators plan to test these relationships by studying~     the changes between 5-24 months and 6 years in middle-ear health, the way the Eustachian tube~     works and Eustachian tube anatomy in cleft palate children.~   "
239286|NCT00423059|"~     Recently, intravitreal bevacizumab (Avastin) injection has gained popularity as a potential~     treatment of intraocular neovascularization (CNV) associated with age related macular~     degeneration and diabetic retinopathy. The efficacy of the drug is thought to be related with~     its pharmacologic blockade of VEGF.~      The purpose of this study is to determine the effect of the intravitreal bevacizumab on the~     fibrovascular membrane associated with proliferative diabetic retinopathy by objective~     histologic evaluation.~      The patients scheduled for vitrectomy for tractional fibrovascular membrane due to~     proliferative diabetic retinopathy will be randomized into two treatment groups. The one will~     receive conventional vitrectomy and the other group will receive intravitreal bevacizumab~     injection one week before the scheduled vitrectomy. The fibrovascular membrane will be~     excised during surgery and fixated for histologic examinations. The expression of VEGF and~     PEDF, a potent inhibitor of angiogenesis, will be evaluated in the fibrovascular membrane by~     immunohistochemistry. The results will be compared between two treatment groups.~   "
239287|NCT00423046|"~     HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals~     has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common~     oncogenic HPV types (HPV-16 and HPV-18), found in > 70%, approximately, of all cervical~     cancers. Recently, Merck's HPV vaccine Gardasil® [quadrivalent human papillomavirus~     (HPV-6,11,16,18 L1 VLP) recombinant vaccine] has been approved by the FDA for prevention of~     genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV~     vaccine and Gardasil® have different compositions and are expected to have different efficacy~     profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and~     pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted.~     This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18)~     to Gardasil® in healthy adult females 18-45 years of age.~      The Protocol Posting has been updated as the study will be extended by 3 additional years.~   "
239288|NCT00423033|"~     The aim of this search is to realize the subjective experiences of employment among~     schizophrenic patients by qualitative analysis. We plan to recruit 50 people diagnosed with~     schizophrenia and divide into two groups, employment and unemployment. Every subjects will~     complete the demographic data, the evaluation of severity of disease, the record of~     medication and an intensive interview about their employment experiences. Finally, we will~     analysis the thick descriptions to understand how schizophrenic patients interpret their~     employment experiences and which factors will affect their successful employment.~   "
239289|NCT00423020|"~     The EPOC-AMI study is to assess the safety and the efficacy of systemic administration of~     erythropoietin for inhibition of neointimal hyperplasia after stent implantation in the~     patients with acute myocardial infarction~   "
239290|NCT00423007|"~     The primary objective of this study is to investigate the efficacy and safety of bromfenac~     ophthalmic solution for treatment in subjects with a history of allergic conjunctivitis~   "
239291|NCT00422994|"~     This study will investigate the effects of severe renal impairment and hemodialysis on the~     characteristics of the drug, ropinirole.~   "
239292|NCT00422981|"~     The purpose of this study is to find out if different doses of Investigational Drug are safe,~     tolerable, and if they have an effect on Mild Cognitive Impairment (MCI).~   "
239293|NCT00422968|"~     The primary objective of the PRE-COMBAT trial is:~      To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting~     balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) compared with bypass~     surgery for the treatment of an unprotected LMCA stenosis. The alternative hypothesis is that~     the experimental strategy (coronary stenting with the sirolimus-eluting stents) is not~     inferior to the standard strategy (bypass surgery).~   "
239294|NCT00422955|"~     Fluid management study in patients with type 2 diabetes and autonomic neuropathy.~   "
239295|NCT00422942|"~     This single arm study will investigate the pattern of B cell depletion in synovial tissue and~     peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15)~     + methotrexate (10-25mg/week po) treatment. The clinical efficacy and pharmacokinetic profile~     of MabThera after treatment and retreatment will also be investigated. The anticipated time~     on study treatment is 2+ years, and the target sample size is <100 individuals.~   "
239296|NCT00422929|"~     This study is to measure over time (from 3 years until 13 years of age) Eustachian tube~     function (the way the Eustachian tube works) and facial growth in groups of children with two~     types of middle-ear disease and with little past middle-ear disease. These measures will be~     used to determine if facial growth is related to improved Eustachian tube function, to see if~     the better function explains why young children who have middle-ear disease outgrow it as~     they get older, and to determine if these measures are different for the children in the~     three groups defined by disease history.~   "
239297|NCT00422916|"~     The intervention program Obeldicks light is developed for overweight children aged 8-16~     years. This intervention is gender - and age specific.~      The 6-month intervention is based on nutrition course, behaviour therapy and exercise~     therapy. The evaluation compromised quality of structure, process and results of the~     intervention. 300 participants in a randomised controlled group design will be evaluated at 4~     time points: baseline, end of intervention, 6 months after end of intervention and 12 months~     after end of intervention.Primary outcome measure is change of weight status as standard~     deviation score of BMI. Drop-outs will be interviewed to improve the intervention.~   "
239298|NCT00422903|"~     Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative~     early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole~   "
239300|NCT00422877|"~     To evaluate objective response rate and duration of response to weekly Taxoprexin®.~      To evaluate the safety profile of weekly Taxoprexin® in this patient population.~      To evaluate overall survival in the same patient population.~      To evaluate time to disease progression, and the time to treatment failure in patients with~     primary liver cancer being treated with weekly Taxoprexin® Injection.~      To explore the trough and peak blood levels of Taxoprexin® and paclitaxel in these patients.~   "
239301|NCT00422864|"~     This trial is a single-arm study for patients presenting with both local and metastatic~     adenocarcinoma of rectum. The aims of the trial are (1) to determine the tolerability rate,~     and (2) to determine toxicity rates, pelvic and distant response rates in patients with~     locally advanced rectal cancer in the presence of distant metastasis who are treated with an~     interdigitating chemotherapy (oxaliplatin/5-fluorouracil [5FU]) and radiotherapy regimen.~   "
239302|NCT00422851|"~     This study will determine if gas can pass between the environment and the middle ear by way~     of the eardrum. This route of gas exchange was observed in animals but has not been studied~     in humans. If gas exchange across the eardrum is documented and the rate is sufficiently~     high, this can help explain certain past observations such as why middle ear pressure does~     not change very much in some children and adults when they have a cold or flu. The~     investigators also expect that the rate of gas exchange across the eardrum will depend on~     whether or not the eardrum has scarred or abnormally thin regions.~   "
239303|NCT00422838|"~     Aim~      To evaluate the effects of peginterferon and ribavirin therapy on the immune response in~     chronic HCV genotype 1,2 or 3 patients before, during and after treatment.~      Background~      Treatment of chronic hepatitis C (HCV) has shown a remarkable success. However, genotype 1~     patients have reduced response rates. A better understanding and improvement of these results~     can now be considered the greatest challenge.~      In chronically infected patients, HCV-specific immune responses are generally weak, narrowly~     focused, and often dysfunctional. The presence of HCV-specific cells suppressing the immune~     response (regulatory T-lymphocytes=Treg) are able to suppress the immune response. These Treg~     are possibly responsible for the impaired immune response.~      Previous studies have indicated increased Treg frequency and activity of immune regulating~     mechanisms, locally in the liver, as a result of HCV re-infection. Hence, these Data~     highlight the importance of monitoring intrahepatic immune responses in addition to~     peripheral immune responses. Using the minimally-invasive technique of fine-needle aspiration~     biopsy (FNAB), it is now possible to obtain safe and frequent liver samples to monitor local~     antiviral immune responses in chronic HCV patients during antiviral therapy.~      Rationale and hypothesis of the study~      Our previous studies and current literature support the concept that Treg may contribute to~     HCV persistence by suppressing HCV-spec immune responses. The current study is designed to~     examine if peginterferon and ribavirin therapy affects the activity of Treg and DC, and if~     this results in enhanced HCV-specific immune responses.~      Design~      Single centre, translational and observational open label study with one arm of 20 genotype 1~     patients and one arm of 7 genotype 2/3 patients.~   "
239304|NCT00422825|"~     This is a single center, four-treatment, four period, crossover study to evaluate the effect~     of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800~     mg modified release tablet, MR2 compared to twice-daily doses of 400 mg film-coated imatinib~     tablets. There will be a 10 day wash out phase between treatments and a 1 week safety period~     at the end of the study. Each participant will receive all four treatments~   "
239305|NCT00422812|"~     Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine~     headaches. In October 2005, we completed a 75 patient, multi-center, double-blind~     placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe~     acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been~     initiated to assess the efficacy and safety in outpatients with migraine headache with or~     without aura.~   "
239306|NCT00422799|"~     In this study, we are trying to find out if the combination of these two drugs is effective~     in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not~     been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and~     Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a~     cancer that is closely related to Waldenstrom's macroglobulinemia.~   "
239307|NCT00422786|"~     The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment~     of patients with previously treated (refractory) renal cell carcinoma~   "
239308|NCT00422773|"~     The purpose of this study is to assess a maximal tolerable dose and to assess the safety of a~     chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-fluorouracil~     (5-FU)/folinic acid (FA) as first-line treatment for metastatic colorectal cancer.~   "
239309|NCT00422760|"~     Clinical Case report Of spontaneous esophageal perforation in a 75 year old man. He prsented~     with breathlessness and on investigation found to have esophageal perforation~   "
239310|NCT00422747|"~     The overall aim of the study is an early asthma diagnosis in young children by the use of~     non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early~     lung function measurements~   "
239311|NCT00422734|"~     To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves~     getting and maintaining an erection in men with erectile dysfunction and if there are~     improvements in the sexual quality of life of the man and his female study partner~   "
239312|NCT00422721|"~     Retinal dystrophies are responsible for numerous cases of blindness, and there are no~     therapeutic possibilities today. Gene therapy is efficient in a dog model concerning~     dystrophy linked to a mutation of the rpe65 gene. If such a therapy is to be considered for~     humans, it is urgent to select, at a national level, patients suffering from dystrophy linked~     to a mutation of the rpe65 gene. The systematic correlation of phenotype/genotype is an~     anatomical-functional approach, but it also identifies patients who may be potentially~     included in a future gene therapy study. Indeed, identification of people with a mutation of~     rpe65 is still insufficient in France (compared to other European countries) because of a~     lack of systemic genotyping of retinal dystrophy.~   "
239366|NCT00422019|"~     The purpose of this study is to evaluate the effectiveness and safety of AMG 102 in patients~     with Advanced Renal Cancer.~   "
239313|NCT00422708|"~     Title: Local anesthesia for office biopsy of the prostate: effects on pain control, quality~     of life and surgical intervention.~      Introduction: Local anesthetic should be administered prior to transrectal needle biopsy of~     the prostate to control pain in the office setting. Various centers have injected anesthetic~     in different regions in and around the prostate prior to biopsy. Patient experience with each~     technique has varied. We would like to determine which procedure provides the best pain~     control. In addition, we would like to know if the anesthetic placement has any effect on~     urinary patterns, bowel habits, and sexual function. Furthermore, for those patients found to~     have cancer and elect surgical treatment, we plan to evaluate if the anesthetic had an impact~     on surgical dissection of their prostate.~      Methods: The investigators plan to identify those patients who require prostate biopsy for~     diagnosis. Each patient will be randomly assigned to a different anesthetic injection group.~     During the biopsy protocol, our nurse will monitor the patient?s pain level according to the~     visual analog score. The patient will complete a pre-biopsy questionnaire and two post-biopsy~     questionnaires administered at 1 and 4 weeks after biopsy. He will receive results of the~     prostate biopsy pathology report within 48 hours by calling his primary referral service.~   "
239314|NCT00422695|"~     There are about 42 million people in the world afflicted with HIV or AIDS with about 1~     million patients in the US.~      The epidemiology of orofacial pain has been reported extensively in the literature, yet the~     prevalence severity and level of pain affecting the head, face, neck and intraoral structures~     has not been explored in a population of HIV infected individuals.~      Pain, in general terms, is a common experience in HIV infected patients, even in the absence~     of cancer or opportunistic infections. There is a variation in the prevalence of pain in~     these individuals depending on the stage of disease, care setting, and study methods. The~     purpose of this study is:~        1. To investigate the prevalence of orofacial pain in HIV infected patients during routine~          dental clinical assessment.~        2. To study the sensory phenotype of HIV+ patients and healthy volunteers using~          Quantitative Sensory Testing:~             -  To detect the presence of sensory aberrations in the orofacial complex;~             -  To identify which nerve types are involved;~             -  To identify the type of orofacial pain based on both sensory testing and clinical~               findings.~        3. To determine psychological condition and nutrition status in patients with HIV.~        4. To find associations between inherited traits and development of neuropathic pain.~   "
239315|NCT00422682|"~     The purpose of the study is to assess the safety and establish the maximum tolerated dose~     (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with~     histologically or cytologically documented advanced solid tumors.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
239316|NCT00422669|"~     The purpose of the Optimize RV study is to determine the long-term effect of selective site~     pacing. Selective site pacing refers to which area of the right ventricle the lead is placed.~     The goal of select site pacing is to improve how the heart contracts when paced in the~     ventricle. By pacing in select sites, it is possible to better copy the natural pattern of~     contraction of the heart.~   "
239317|NCT00422656|"~     Waldenström's Macroglobulinemia (lymphoplasmacytic lymphoma, WM) remains incurable with~     limited therapeutic options and notably absent FDA approved therapy with any WM indication.~     Therefore, there is a need to identify new therapeutic agents for WM patients both in the~     upfront and relapsed/refractory setting. The purpose of this research study is to assess the~     efficacy of perifosine in patients with relapsed or refractory WM.~   "
239318|NCT00422643|"~     Osteoarthritis is the most common disease effecting human beings with incidence of about 20%~     and prevalence close to 80% of the adult population. It is most common after the age of 60~     years and more in females with the ratio 4:1 F:M. Osteoarthritis Can be present in every~     hyaline joint, but is mostly damaging to the weight bearing joints, the knees and hips. At~     the final stage of cartilage destruction (from wear and tear) joint replacement is the~     solution. Since these operations were introduced about 50 years ago, the indications and the~     number of yearly procedures has been increasing with alarming speed. Last year in the united~     states, about 500,000 Total Knee procedures were done, exceeding Total Hip replacements.~      By 2030, close to 4.5 million joint replacement procedures are expected in the United States,~     the majority of which will be knee replacements. Joint replacement is the solution for the~     final stage of damaged cartilage. In early and advanced stages of cartilage wear and~     specifically in the knee H.A. acts as an anti inflammatory and lubricant agent, reducing the~     knee pain and improving knee motion and function.~      The biological effect of H.A. is well documented in clinical studies and less with scientific~     evidence derived from patients themselves.~      Our study proposal briefly is, as follows:~      60 patients with evidence of osteoarthritis of the knees will join the study after I.R.B.~     (Helsinki Committee) approval. All of them will be examined, x-rays will be performed and~     blood tests will exclude patients with infections or inflammatory disease. A V.A.S. (Visual~     Analog Score) and SF-36 evaluation form will be completed prior to each intraarticular~     injection, in addition to a complete medical examination. The enrolled patients will receive~     the usual three intraarticular knee injections of H.A.(Arthrease), but prior to each~     injection, the joint will be aspirated and the joint fluid will be analyzed for Chondroitin~     sulfate type I and type II as described further in this project.~      Three and six months after the third initial injections, the patients will recalled and joint~     fluid will be aspirated again, followed by an H.A. injections, if symptomatic.~      This study is the only one ever proposed, for evaluating joint debris qualitatively and~     quantitatively. It will provide clinical information as well as objective data on the~     preservation of the joint cartilage. Hopefully, this study will provide additional~     information such as the relationship between the presence of debris and symptomatic vs.~     asymptomatic patients. It may help in determining how long the injected H.A. has an effect~     and whether serial and periodical injections are indicated.~      Inclusion criteria:~      1. patients with the diagnosis of Osteoarhtritis of the knee, graded according to Kellgren as~     grade 1-4~      Exclusion criteria:~        1. Patients that suffer from acute septic arthritis.~        2. Patients that treated with coumadin and/or other anti-coagulant drugs~        3. Patients that show mental or physical conditions, which preclude compliance with study~          and/or device.~   "
239319|NCT00422630|"~     Current estimates suggest that 65% of American adults are overweight or obese. Excess body~     weight has been associated with an increased risk of a number of metabolic abnormalities,~     including high blood sugar, high blood pressure, high triglyceride levels, and low HDL~     (good) cholesterol levels. Insulin resistance (when the body becomes less sensitive to the~     blood sugar-lowering hormone insulin, and more of the hormone is needed to keep blood sugar~     levels under control) also frequently occurs as a result of excess body weight. These~     abnormalities can all increase the risk of heart disease and other serious medical problems.~     Individuals who are overweight often have a number of these abnormalities at the same time, a~     situation which is often called the metabolic syndrome. Dietary changes, physical activity,~     and weight loss can lead to improvements in each of the metabolic abnormalities described~     above. However, the best type of diet for people with the metabolic syndrome is not known.~     This study has been designed to test the effects of several promising dietary patterns, with~     and without weight loss, in overweight adults with the metabolic syndrome. Most individuals~     who have the metabolic syndrome do not know they have the condition, so we will be screening~     many healthy overweight volunteers to see if they may be eligible.~   "
239320|NCT00422617|"~     An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly~     intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis~   "
239321|NCT00422604|"~     The safety, tolerability, pharmacokinetics and pharmacodynamics/efficacy profiles of two~     different doses of GSK233705 will be compared with 2 active comparators and placebo, all~     medication delivered via dry powder inhaler.~   "
239322|NCT00422591|"~     The goal of this clinical research study is to find out if standard chemotherapy given with~     idarubicin and Cytarabine (ara-C) can help to control AML.~      Objectives:~      To determine the complete response (CR) rate, event-free survival (EFS) and overall survival~     (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard~     combination chemotherapy with Idarubicin and cytarabine.~   "
239323|NCT00422578|"~     Study is a clinical study assessing the effect of oral tadalafil 10mg or 20 mg on~     psychosocial aspects and quality of life of erectile dysfunction patients and to compare~     tadalafil with previous oral erectile dysfunction medication. Study period is 13 weeks. Study~     patients fill in quality of life questionnaires and treatment satisfaction questionnaires.~   "
239324|NCT00422565|"~     The trial has the following primary objective:~      To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting~     balloon expandable stent (Medtronic, Minneapolis, MN) vs. sirolimus-eluting balloon~     expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) vs. paclitaxel-eluting stent~     (Taxus Liberte, Boston Scientific).~   "
239325|NCT00422552|"~     The purpose of this study is to assess the change in inspiratory capacity and lung function~     in patients with chronic obstructive pulmonary disease when treated with indacaterol compared~     to placebo and formoterol.~   "
239326|NCT00422539|"~     This study aims to determine the efficacy of 70% trichloroacetic acid on atrophic scars of~     varicella~   "
239327|NCT00422526|"~     The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on~     the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with~     a short cervical length of 15mm.~   "
239328|NCT00422513|"~     This 2 arm study will compare 'time and motion' (provider time spent on anemia management)~     and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera)~     and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis.~     Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive~     standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360~     micrograms (iv), monthly. After a titration period, average time spent on anemia treatment~     over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12~     months, and the target sample size is 100-500 individuals.~   "
239329|NCT00422500|"~     Primary Objectives:~        -  To compare the severity of symptoms, their impact on affective and health-related~          functional status, and symptom interference among patients with advanced-stage lung~          cancer following initiation of chemotherapy by disease status, tumor response to~          chemotherapy, and adequacy of symptom management.~        -  To examine the relationship of disease-related and treatment-related physical symptoms~          to affective impairment and the patient's reported symptom interference and functional~          impairment.~        -  To compare symptom severity, adequacy of symptom management, and interference with~          affective status and health-related function by patient's minority status.~        -  To explore the serum level of inflammatory cytokines during chemotherapy among lung~          cancer patients.~        -  To measure DNA repair capacity (DRC) in lymphocyte cultures of all patients enrolled in~          the protocol at baseline (before treatment) and during each follow-up blood draw. The~          hypothesis is that patients with suboptimal DRC will do better with chemotherapy than~          patients with efficient DRC.~        -  To extract DNA and genotype for polymorphisms in genes involved in the nucleotide~          excision repair pathway and in those involved in response to pain (opioid receptors,~          dopamine receptors, COMT). We hypothesize that:~             1. Polymorphisms in NER genes that modulate DNA repair capacity will also effect~               response to chemotherapy and to outcome.~             2. Cytokine gene polymorphisms account for variations in symptom outcomes (specific~               symptoms and symptom clusters) before, during and after chemotherapy.~             3. The COMT val/met polymorphism affects the metabolism of catecholamines on the~               modulation of response to sustained pain.~             4. Dopamine receptor polymorphisms that result in decreased density of dopamine~               receptors will result in a deficit in the dopamine pathway. that will also affect~               response to pain.~        -  To evaluate neurocognitive function to determine the prevalence, severity, and pattern~          of cognitive symptoms.~   "
239330|NCT00422487|"~     The purpose of this study is to collect important information regarding the glucose-lowering~     efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in~     diabetics. It will also provide important information about the appropriate doses to be used~     in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and~     in combination with other anti-diabetic agents.~   "
239331|NCT00422474|"~     After acute stroke, baroreflex sensitivity (BRS) is impaired. This impaired acute stage BRS~     has been reported to be predictive of worsen outcome years after stroke in general. However,~     it is not very clear if the impaired acute stroke BRS would actually persist months after the~     acute stage. It is also not clear that such change, if any, would correlate with the~     functional outcome or prognosis after stroke.~      The trial is to investigate the longitudinal time course of BRS after ischemic stroke up to~     the 6th month post stroke and to see if there is any correlation of the changes in BRS with~     the functional outcome parameters using NIHSS and mRS scores throughout this period.~   "
239332|NCT00422461|"~     The purpose of this study is to evaluate the safety and blood pressure lowering effect of~     different doses of PF-00489791 in patients with mild to moderate high blood pressure~   "
239333|NCT00422448|"~     This project is a multicenter study in which we will investigate a dual concept of~     nevogenesis. Study location is the Department of Dermatology at the Medical University of~     Graz in collaboration with centers in Austria (Vienna), Italy (Naples, Benevento, Modena),~     Spain (Barcelona) and the United States (New York).~      The hypothesis is that small congenital melanocytic nevi (CMN), early acquired melanocytic~     nevi in childhood (AMN) and dermal nevi, all dermatoscopically characterized by globular~     pattern, belong to the same spectrum of genetically determined melanocytic proliferations~     that develop due to endogenous pathways, in contrast to true acquired melanocytic nevi,~     dermatoscopically showing reticular pattern, that develop due to exogeneous factors such as~     UV-exposure.~   "
239334|NCT00422435|"~     This study is designed to evaluate the performance and safety of a new catheter system.~   "
239335|NCT00422422|"~     Initial study in children with epilepsy to evaluate the pharmacokinetics, safety,~     tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to~     develop dosing adaptations for future studies.~   "
239336|NCT00422409|"~     Obstruction of the digestive tract is a frequent cause of morbidity in patients with~     gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal~     stents(SEMS)is an alternative to palliative surgery and other palliative treatment~     options.The method has expanded to include patients with malignancies in the~     esophagus,gastroduodenal region, biliary tractus and colon. Numerous retrospective studies~     have reported treatment with SEMS to be safe and effective. Prospective studies,and~     especially studies regarding Quality of Life improvement are needed.~      PURPOSE:~      The purpose of this trial is to prospectively study the use and effect of selfexpanding metal~     stents(SEMS)in a defined population i Norway, especially Quality of Life changes.~   "
239337|NCT00422396|"~     This is a randomized placebo controlled clinical trial designed to investigate the effects of~     micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and~     lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic~     individuals with two or more other characteristics of the metabolic syndrome.~   "
239338|NCT00422383|"~     This study will evaluate the efficacy and safety of various treatment and retreatment~     regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly~     either orally or parenterally. The anticipated time on study treatment is 2+ years, and the~     target sample size is 100-500 individuals.~   "
239339|NCT00422370|"~     Over 10% of adult population suffers from dry mouth (xerostomia). The aim of this double~     blind prospective clinical trial is to examine a new lipid based food additive formulation to~     ease mouth dryness in these patients.~   "
239340|NCT00422357|"~     Diabetes mellitus is the most common metabolic disorder worldwide. Some herbs are~     traditionally used in treatment of type 2 diabetes mellitus (T2DM). Urtica Dioica (UD) or~     stinging nettle is traditionally used in Morocco, Turkey, Brasil, Jordan and with much~     frequency in northern Iran.~      Studies on animal models along with in vitro studies has shown hypoglycemic effect for~     aqueous extract of UD.~      This study aimed to investigate hypoglycemic effects of UD tea bags in patients with T2DM on~     glycemic control, insulin sensitivity, along with its effects on lipid profile (LP), blood~     pressure (BP), liver, and kidney function.~   "
239341|NCT00422344|"~     The purpose of this study is to test the safety of RAD-001 and Sunitinib given in combination~     for renal cell cancer. We also want to find out what effects (good and bad) the combination~     of RAD-001 and Sunitinib have on you and your tumor.~      RAD001 is a pill that works by shutting down some of the pathways in the cell that make~     tumors grow. Sunitinib is a pill that works by shutting off the signal in the cancer cells~     that tell the cells to grow blood vessels. Without this signal, the blood vessels to the~     tumors shrink down.~   "
239342|NCT00422331|"~     The purpose of this study is to determine whether Lithium is safe and effective in the~     treatment of Bipolar I Disorder subjects with symptoms of acute mania.~   "
239343|NCT00422318|"~     The study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and~     (II) to test the effect of lowering UA by uricosuric treatment in CHF.~   "
239344|NCT00422305|"~     The purpose of this study is to evaluate the growth of the lung and how easily gas can be~     taken up by the lung in healthy infants born at full term without any breathing problems and~     infants born prematurely.~   "
239345|NCT00422292|"~     This is a modified single-blind, randomized, parallel-group, comparative, multicenter study~     to test Menactra vaccine in toddlers.~      Primary Objectives:~        -  To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella~          (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.~        -  To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when~          administered alone or concomitantly with Menactra vaccine.~      Observational Objectives:~      Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6~     months after the last study vaccination[s]) in subjects in the study groups.~      Immunogenicity:~      - To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days~     after the first and second Menactra vaccine administration in a subset of subjects in the~     first study group.~   "
239346|NCT00422279|"~     The purpose of the study is to evaluate implant stability and stimulate clinically relevant~     horizontal and vertical new bone formation around Nobel Biocare's Bone Inductive Implant.~   "
239347|NCT00422266|"~     The incidence of chronic degenerative diseases, especially cardiovascular disease (CVD), is~     high world over and especially in India. High blood cholesterol and triglyceride levels are~     known to be important risk factors for CVD. There is a strong body of evidence for the~     beneficial effects of plant sterols on blood total and LDL-cholesterol and omega-3 fatty~     acids from fish on blood triglycerides. However, the combined benefits of consuming both~     plant sterols and omega-3 fatty acids from fish oil on blood cholesterol and triglycerides~     has not been investigated previously, except in one study where the methodology used was not~     the most appropriate for testing such a combination. In addition, most studies on plant~     sterol efficacy realised so far were done in Western countries. The present study will~     investigate the efficacy of plant sterols and omega-3 fatty acids from fish oil on improving~     the cardiovascular risk profile of Indian adults with dyslipidemia.~      It is expected that, after 4 weeks of intervention, men consuming both plant sterols and~     omega-3 fatty acids from fish oil will have a lower cardiovascular risk profile than men~     receiving only plant sterols or only fish oil or none of these dietary supplements.~   "
239348|NCT00422253|"~     We hypothesize that reduction in dietary advance glycation endproducts (AGE) intake will~     increase insulin sensitivity and normalise insulin secretion in overweight and obese~     individuals through reduction of chronic low grade inflammation.~      We propose to test this hypothesis by performing euglycemic hypeinsulinemic glucose clamp and~     intravenous glucose tolerance test before and after low AGE diet and normal Australian diet~     in a cross-over design. This study will provide information relevant to the development and~     prevention of type 2 diabetes.~   "
239349|NCT00422240|"~     This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of~     treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening~     (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment~     evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a~     subject should remain the same during the study.~      The primary objective is to demonstrate the superiority in efficacy and assess safety of~     adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene~     topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide~     monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12~     weeks.~   "
239350|NCT00422227|"~     The purpose of this study is to compare the efficacy of etanercept with usual~     disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe~     rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.~   "
239351|NCT00422214|"~     The purpose of this study is to determine the safety and efficacy of sustained-release~     quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression~     for 8 weeks.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
239367|NCT00422006|"~     Experimental results are strongly suggesting that PCSK9 and FXR could occur in the~     physiopathology of human joined dyslipidemia. But no data in the literature can validate the~     potential role of these two genes in the lipidic and glucidic metabolism control in~     physiopathological situations. This protocol is based on the hypothesis that the expression~     levels of PCSK 9 and FXR are modified for some patients suffering from insulin resistance and~     dyslipidemia.~   "
239443|NCT00421005|"~     Statin therapy is a treatment with a proven positive impact on survival after heart~     transplantation. However, it is unclear whether the beneficial effect of this class of drugs~     depends solely on their LDL-lowering properties or on anti-inflammatory and immuno-modulatory~     properties. Thus, this study was designed to compare safety and efficacy of two different~     strategies: 1. high fixed statin dose vs. 2. low starting dose with LDL-driven doses~     adjustments.~   "
239352|NCT00422201|"~     This study will evaluate whether the drug mifepristone can improve the symptoms of Cushing's~     syndrome in people with ectopic adrenal corticotrophin hormone (ACTH) secretion. Cushing's~     syndrome occurs when the adrenal glands produce too much cortisol, a hormone that helps to~     regulate the body's use of salt and food. Excessive cortisol is usually the result of too~     much ACTH, the hormone that causes the adrenal glands to make cortisol. The extra ACTH is~     made either by a tumor in the pituitary gland (called Cushing's disease) or by a tumor~     somewhere else (called ectopic ACTH secretion). Mifepristone blocks the action of cortisol in~     the body. The drug has been used safely to treat a few people with Cushing's syndrome and~     patients with certain kinds of cancer, gynecological diseases and psychiatric disorders.~      People between 18 and 85 years of age with Cushing's syndrome caused by EXCESS ACTH secretion~     may be eligible for this study. Candidates are admitted to the hospital for evaluation to~     confirm Cushing's syndrome and to determine its cause. The evaluation includes blood and~     urine tests, imaging tests, dexamethasone and corticotropin-releasing hormone tests and~     inferior petrosal sinus sampling. Patients determined to have Cushing's syndrome due to~     ECTOPIC ACTH secretion undergo imaging studies (CT, MRI and a nuclear medicine scan) and~     begin mifepristone therapy.~      Participants remain in the hospital for the following tests and procedures:~        -  Physical examination, electrocardiogram (EKG) and blood and urine tests~        -  Completion of medical questionnaires~        -  DEXA scan to determine bone mineral density and body composition~        -  Glucose tolerance test~        -  Urine pregnancy test and ultrasound to measure uterine lining thickness (for women)~      Patients take mifepristone by mouth 3 times a day. The dose is increased every week or so~     until symptoms improve or the highest dosage allowed is reached. Patients may remain in the~     hospital for all or part of the dose-finding part of the study. During this period (usually 2~     to 4 weeks), blood pressure, glucose tolerance and blood chemistries are measured and EKG and~     urinalysis done every 5 to 14 days. When the mifepristone dose is stable patients remain on~     that dose for at least 2 weeks and are then re-evaluated. Patients then return to the~     hospital for evaluations every 3 months. Those who do well on the drug may continue to take~     it for up to 12 months.~   "
239353|NCT00422188|"~     The purpose of this research is to compare the safety and effectiveness of 4 different~     concentrations of deoxycholic acid injection against a placebo in the treatment of~     superficial lipomas.~   "
239354|NCT00422175|"~     The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on~     bodily functions as well as the body's absorption, distribution, metabolism, and excretion of~     BAF312 in healthy volunteers~   "
239355|NCT00422162|"~     An eight-week, randomized, double blind, two parallel groups, study to assess clinical~     response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for~     severe depression.~   "
239356|NCT00422149|"~     To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction~     in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from~     IgE mediated allergic complaints triggered by grass pollen.~   "
239357|NCT00422136|"~     The goal of this study is to identify the genes that contribute to susceptibility to~     recurrent/persistent middle ear disease. Five hundred families with at least 2 children who~     have undergone tympanostomy tube insertion will be enrolled. A blood sample will be obtained~     from the children who had tubes and any available parent (at least 1), as well as any~     siblings without significant histories of middle ear disease.~   "
239358|NCT00422123|"~     The purpose of this study is to determine the safety and efficacy of sustained-release~     quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3~     weeks.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
239359|NCT00422110|"~     This study will evaluate the effectiveness and safety of seletracetam when it is used in~     addition to other anti-epileptic medications by patients with partial onset seizures. It will~     also help to determine the best dose to use.~   "
239360|NCT00422097|"~     This study will determine the maximum tolerated dose of oral ixabepilone administered for 5~     successive days every 21 days in participants with advanced cancer. The safety, tolerability,~     and pharmacokinetics of ixabepilone in the body will be studied. In addition, this study will~     assess preliminary evidence of the effect of food and famotidine on the pharmacokinetics of~     oral ixabepilone.~   "
239361|NCT00422084|"~     The purpose of this study is to compare the efficacy and safety of the fixed combination of~     pyronaridine artesunate (180:60 mg) with that of Coartem® (artemether lumefantrine) in~     children and adults with acute uncomplicated P falciparum malaria.~   "
239362|NCT00422071|"~     This study will use transcranial magnetic stimulation (TMS) to determine whether the activity~     in the brain when someone wins something affects the part of the brain that controls~     movement. Studies have shown that the brain releases signals to mark rewards for certain~     behavior, like the activity the brain generates when an animal receives food or drink after~     performing a certain action. This study will look for a way to detect this kind of signal in~     humans.~      Healthy volunteers between 18 and 60 years of age are eligible for this study. Participants~     undergo TMS during two experiments slot machine stimulation and key sequence (see below). For~     TMS, a wire coil is held on the subject s scalp. A brief electrical current is passed through~     the coil, creating a magnetic pulse that stimulates the brain. The stimulation may cause~     twitching in muscles of the face, arm or leg, and there may be a pulling sensation on the~     skin under the coil. The effect of TMS on the muscles is detected with small metal disk~     electrodes taped onto the skin of the arms or legs.~      The stimulation strength needed to activate the hand muscles is determined at the beginning~     of each experiment. To do this, the subject sits with his or her arms and hand relaxed.~     Magnetic pulses of varying strengths are applied in order to find the right strength. Also, a~     series of 45 pairs of magnetic pulses is administered so close to each other that they~     produce only one movement. Measurements of the movements generated serve as a baseline for~     comparison with movements generated during the experiments.~      Slot Machine Simulation~      Subjects play a computer game similar to a slot machine. They press a button to start the~     game and watch as three barrels of the machine spin into place. Subjects can win $0.25, $1or~     $5 if all three barrels match when they stop spinning. If all three barrels do not match,~     subjects do not win any money, except in rare instances, when they are awarded money even~     when all three barrels do not match. In one trial in this experiment, subjects receive~     transcranial magnetic stimulation after they see the second barrel stop spinning. In another~     trial, they receive the stimulation after the third barrel stops spinning.~      Key Sequence~      Subjects see a letter on a computer screen and press a combination of the three keyboard keys~     G, H, and J. If they press the keys in the right order and under the time limit, they win $1.~     At some point, the letter displayed changes, and the subjects must guess a new combination to~     earn money. Each of the letters corresponds to its own combination of key presses. A few~     moments after the subjects see whether they pressed the keys in the right order, they receive~     TMS.~   "
239363|NCT00422058|"~     This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the~     efficacy of liraglutide to induce body weight loss and the purpose of the extension is to~     evaluate the long term safety and tolerability of liraglutide.~      Trial has the following trial periods: A 20-week randomised, double-blind,~     placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open~     label orlistat comparator arm followed by an 84 week extension period.~   "
239364|NCT00422045|"~     The primary objective of this study is to assess whether or not low level laser therapy~     (LLLT) decreases pain in post-operative orthopedic patients following lumbar fusion surgery.~   "
239365|NCT00422032|"~     The goal of this clinical research study is to compare the effectiveness of 2 different doses~     of the drug clofarabine that can be given on a weekly schedule for the treatment of~     Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared.~      Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS.~      Secondary Objective: Compare response durations, survivals and side effects of the two~     schedules.~   "
239368|NCT00421993|"~     This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of~     treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening~     (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment~     evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a~     subject should remain the same during the study.~      The primary objective is to demonstrate the superiority in efficacy and assess safety of~     Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene~     Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide~     Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12~     weeks.~   "
239369|NCT00421980|"~     The primary objective of this study was to determine the long-term safety of etanercept in~     adults with AS who had completed study 0881A3-311-EU.~   "
239370|NCT00421967|"~     Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain.~     Although epidural treatment provides good and reliable postoperative pain relief after THA,~     it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed~     mobilization.~      The challenge of new analgesic regimes is to reduce the occurrence of side effects while~     maintaining adequate pain relief and maximum muscle control. A relatively new method to~     provide postoperative pain relief after TKA is local infiltration analgesia combined with~     single-shot injection(s) or continuous infusion of local anesthetics into the surgical site.~     As local infiltration analgesia combined with continuous intraarticular infusion compared~     with continuous epidural infusion has not been evaluated, our study was designed to determine~     whether this technique could enhance analgesia and improve patient outcome after TKA. This~     study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with~     local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with~     continuous intraarticular infusion of Ropivacaine and Ketorolac.~   "
239371|NCT00421954|"~     This open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients,~     aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for~     7 weeks and stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically~     appropriate, they may also stay at the New York State Psychiatric Institute (NYSPI)~     Schizophrenia Research Unit (SRU) inpatient facility.~   "
239372|NCT00421941|"~     The purpose of this study is to evaluate the clinical applicability of an enteral tube~     feeding formula containing fish oil and prebiotics in a critical care population.~   "
239373|NCT00421928|"~     The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety~     of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250~     mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the~     knee, in comparison with placebo and Oxycodone Controlled Release (CR).~   "
239374|NCT00421915|"~     The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice~     weekly) with that of placebo based on the percentage of patients who achieve the Assessment~     in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.~   "
239375|NCT00421902|"~     Patients with prostate cancer who are / were treated with hormonal treatment and developed~     hot flashes as a side effect are offered Acupuncture as an investigational intervention. The~     treatment is performed twice a week for four weeks, then once a week for the following six~     weeks~   "
239376|NCT00421889|"~     The study seeks to assess the safety, pharmacodynamics, pharmacokinetics and efficacy of~     belinostat (PXD101) administered in combination with carboplatin or paclitaxel or both in~     patients with solid tumours followed by maximum tolerated dose (MTD) expansion (phase II) in~     ovarian and bladder cancer patients~      The clinical trial is now in the MTD (phase II) portion of the study enrolling bladder cancer~     patients. Enrollment of ovarian patients is complete.~   "
239377|NCT00421876|"~     Cardiac rehabilitation programmes are a proven treatment for individuals with recent~     myocardial infarction, resulting in reduced morbidity and mortality compared to usual care.~     Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and~     lifestyle behaviours may deteriorate. The GOSPEL study investigates the benefits of a~     programme of continued educational and behavioural intervention to achieve optimal long-term~     secondary prevention goals.~   "
239378|NCT00421863|"~     Multicenter, prospective, randomised, open study comparing the effect of the following two~     strategies in hypertensive subjects > 55 years and poorly controlled (systolic blood pressure~     >= 150 mmHg) by antihypertensive treatment:~        -  usual strategy: reduction of systolic blood pressure to below 140 mmHg, independently of~          diastolic blood pressure levels;~        -  intensive strategy: reduction of systolic blood pressure to below 130 mmHg,~          independently of diastolic blood pressure levels.~      During the initial run in period two qualifying visits at distance of 7-14 days will be~     carried out to establish whether blood pressure remains uncontrolled (systolic blood pressure~     >=150 mmHg)by current drug treatment. At the end of the second visit eligible patients will~     be admitted to the study and the following examinations will be carried out: clinical visit,~     routine laboratory tests, 12-lead ECG. At this point eligible patients will be randomised to~     one of the two blood pressure goals outlined above.~      Subsequent clinical visits will be carried out at 4 month-intervals up to the end of the~     study (4, 8, 12, 16, 20, 24 months).~   "
239379|NCT00421850|"~     The costs of diabetes care (in health care dollars & human suffering) in the United States~     are second only to mental illness. Randomized control trials & observational studies have~     shown that glycemic control is predictive of the onset & severity of complications from~     diabetes and costs of care. In addition, a significant percentage of costs associated with~     diabetes can be reduced or delayed by appropriate diagnosis, preventive strategies, &~     management. The Planned Care Model (advocated by the Institute for Healthcare Improvement)~     has shown success in demonstrating improved practice performance and patient outcomes during~     a limited pilot in our clinical practice. We are proposing to generalize the Planned Care~     Model, to assess the value of planned care for all people with diabetes. The Planned Care~     Model will be implemented at each practice site and will consist of a structured~     communication schema between the patient and the primary health care team, to improve care~     for people with diabetes. Traditional care will be defined as the traditional system of care~     for patients prior to their participation in the Planned Care Model. It is hypothesized that~     this Planned Care Model will improve compliance with appropriate care guidelines and improve~     short and long term health outcomes (metabolic, satisfaction, morbidity, mortality and~     healthcare utilization). In conjunction with this study, providers at each of the practice~     sites will be randomly assigned to a structured communication with specialty care, referred~     to as UNITED Planned Care (Use of Networks, Informatics, Telemedicine, and Education in~     Disease Management). This communication schema will only be possible once the assigned~     provider?s patient is participating in the Planned Care Model. The UNITED Planned Care model~     will include point-of-care evidence based messages and specialty advice determined by~     performance gaps and outcomes for the patient. UNITED Planned Care is hypothesized to have~     the greatest impact on short & long term health outcomes.~   "
239380|NCT00421837|"~     Influenza (the flu) is a leading cause of respiratory (breathing) illness that leads to~     sickness and death during the winter months. A better understanding of why certain people get~     the flu or get sicker with the flu than other people is important for developing improved~     vaccines and treatments. This study will look at the genetic makeup (determines each person's~     specific characteristics and traits) of 50 patients, older than 50, who were hospitalized~     with flu at Vanderbilt University during the 2006-2007 flu season. Their genetic makeup will~     be compared with the genetic makeup of 50 people who are not related but were in close daily~     contact with the flu patient and were not infected with flu virus. The study staff will~     collect a blood sample (contains genetic material) from each participant (flu patients and~     their contacts) for comparison. Flu patients will have completed a health survey as part of~     the previous study, and their contacts will complete a shorter version of this survey.~   "
239381|NCT00421824|"~     Primary:~        -  To assess complete pathological response rate of both strategies.~      Secondary:~        -  Safety profile~        -  To assess downstaging rate of both strategies.~        -  To compare relative dose intensity of oxaliplatin and capecitabine of both strategies~        -  To compare time to progression and overall survival of both strategies.~   "
239382|NCT00421811|"~     N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor~     cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the~     safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of~     Melphalan in subjects with locally advanced malignant melanoma.~   "
239383|NCT00421798|"~     This study will test a method of detecting tuberculosis-causing bacteria that are resistant~     to current medication treatments. Blood samples will be collected from patients from 3 sites~     and 3 mainly Hispanic populations in Texas, Mexico, and Colombia. Up to 780 males and~     females, ages 18-85 years, will participate. The study population will consist of 390 people~     with any of 3 forms of tuberculosis (TB) and 390 people who are either healthy or with a~     disease initially thought to be one of these 3 forms of TB but then ruled out. Volunteers~     will only be contacted, invited to participate and interviewed at the beginning of their~     evaluation for possible TB.The study team will follow up with the health department to~     determine if the volunteer was indeed diagnosed with TB, and with the laboratory to determine~     the results of TB tests at diagnosis and during the course of treatment.~   "
239384|NCT00421785|"~     The aim of our study is to investigate the effect of N-acetylcysteine on peritoneal small~     solute clearance and removal of salt and water in prevalent CAPD patients.~   "
239385|NCT00421772|"~     Isolated uni or bilateral mild cerebral ventriculomegaly represents the most frequent “minor”~     cerebral anomalies discovered by antenatal echography. There are not French data making it~     possible to specify the incidence and the prevalence of this pathology and international data~     of the prevalence are very heterogeneous, going, according to the published series, of 1.48~     to 22 per 1000 births.~      The prognostic of ventriculomegaly remains dubious : the studies have small populations, are~     for the majority retrospectives with a short and often vague follow-up. The announced rate of~     after-effects varies between 0 and 48 %.~      The objective of this study is to evaluate the neuropsychological development until the 5~     years age of the children for whom a prenatally diagnosis of mild isolated ventriculomegaly~     was carried (absence of another cerebral or extra-cerebral anomaly in imagery and a negative~     aetiology). This prospective cohort will be compared with children for whom no neurological~     anomaly was prenatally detected.~      The children diagnosed for an mild isolated cerebral ventriculomegaly will be identified by~     the investigators among medical files of the Centers of Prenatal Diagnosis (CPDPN) of the UH~     of Angers and the UH of Nantes. The patient inclusion will be done at the 2 years age after~     parental agreement, with a follow-up at 5 years. The control children will be included under~     the same conditions after having ensured of the normality of the echographies of 22 and 30~     gestational weeks. The follow-up of these 2 cohorts will be based on the 2 years obligatory~     paediatric examination, and on the network “Naitre ensemble” set up in the Pays de la Loire~     Loire. In addition to the clinical routine examinations, standardized neuropsychological~     examinations will be done (Brunet Lezine Revised score at 2 years, NEPSY at 5 years and ASQ~     at 2 and 5 years).~      This study will allow to compare the neuropsychological development at school age of the~     children diagnosed for a foetal mild, apparently isolated, cerebral ventriculomegaly from~     children not presenting any foetal anomaly, to evaluate the incidence of the mild isolated~     ventriculomegaly, to identify the predictive factors of the neuropsychological anomalies in~     the children diagnosed for ventriculomegaly and to compare (in the children diagnosed for~     ventriculomegaly), the neuropsychological development at the school age of the children~     having a ventricular atrium between 10 and 12 mm with those having a ventricular atrium~     between 12,1 and 15 mm.~      This study will allow to define the neuropsychological morbidity of the foetal mild isolated~     cerebral ventriculomegaly and will allow to define the best clinical and educational follow~     up of these children and their family.~   "
239386|NCT00421759|"~     The long-term goal of this project is to develop a non-invasive, noise-based technique for~     enhancing somatosensation and thereby improving balance control in elderly fallers and older~     adults with somatosensory deficits.~   "
239387|NCT00421746|"~     The purpose of this study is to determine whether piboserod, a serotonin-4 receptor~     antagonist, is effective for the treatment of patients with congestive heart failure.~   "
239388|NCT00421733|"~     The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of~     paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD)~     who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme~     (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy.~   "
239389|NCT00421720|"~     This prospective, randomized, multicenter, open-label study will compare two analgesia-based~     regimens for sedation (remifentanil/propofol vs. sufentanil/propofol) in medium to long-term~     ventilated intensive care patients in terms of efficacy, safety and resource utilization.~      The special characteristics of intensive care patients (organ insufficiencies etc.) regularly~     cause an accumulation of the analgesics, sedatives and adjuvants used. Clinically, this~     complicates the calculation of weaning and extubation times, often making mechanical~     ventilation necessary for longer periods than desired and also extending the stay of patients~     in the intensive care unit. Reducing weaning times and the duration of intensive care~     treatment by optimizing analgesia/sedation could furthermore lead to a reduction in typical~     complications such as ventilator-associated pneumonia or delirium.~      The demands on an ideal analgesic are analgesic efficacy without severe cardiopulmonary~     depression and rapid onset of effect and in particular a short dura-tion of effect and~     absence of accumulation or development of active metabolites. Remifentanil is an ultra-short~     acting µ-agonist which is, due to its molecular structure, metabolized organ-independently by~     unspecific blood and tissue esterases with the substance being degraded within only a few~     minutes and the resulting metabolites being virtually ineffective at the µ-receptor.~     Sufentanil, on the other hand, is mainly metabolized by the cytochrome P-450-3A4 enzyme in~     the liver and small intestine.~      To date, only one study with a small sample size is available on the comparison of the~     effectiveness and safety of remifentanil and sufentanil when used for long-term~     analgesia/sedation.~   "
239390|NCT00421707|"~     This is a double-blind, placebo-controlled, randomised crossover study to investigate the~     efficacy and safety of GW876008~   "
239391|NCT00421694|"~     Following radical prostatectomy (RP), about 20% to 40% of the patients with prostate cancer~     (PCa) exhibit pathological parameters which are associated with a high risk of disease~     recurrence. The rationale for NHT is based on the theory that androgen ablation induces PCa~     apoptosis which induces a regression of the primary tumor bulk before RP. However the use of~     NHT prior RP is highly controversial. In spite of these unenthusiastic results, the relative~     short time of treatment and the use of different drugs from those utilized in other trials~     might still to make this regimen attractive in terms of drug related side effects and~     effectiveness. In this regard, Bicalutamide presents unique characteristics since it work~     differently respect to other anti-hormonal agents by interfering on both genotropic and~     non-genotropic mechanisms of androgen receptor~   "
239392|NCT00421681|"~     The purpose of this study is to assess the comparative effects of two different ways of~     enhancing long-term adherence to and benefits associated with participation in the~     evidence-based, Fit and Strong multi-component exercise intervention for older persons with~     lower extremity osteoarthritis.~   "
239393|NCT00421668|"~     A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or~     placebo among 2400 children born to HIV-negative Tanzanian mothers.~   "
239394|NCT00421655|"~     The trial is performed to evaluate the efficacy and safety of specific immunotherapy with~     Grazax for treatment of grass pollen induced allergy.~   "
239395|NCT00421642|"~     This is an open-label study of 20 patients designed to demonstrate the safety, tolerability~     and preliminary evidence of benefit of adalimumab in the treatment of subjects with~     Ulcerative Colitis, both in patients who have never received anit-TNF agents and in those who~     have lost response or developed intolerance to previous infliximab therapy.~   "
239396|NCT00421629|"~     The purpose of this study is to assesses interventions aimed at improving the distributional~     impact of a community based health insurance scheme in rural India.~   "
239397|NCT00421616|"~     Several studies have reported greater weight loss when following high meat-protein diets but~     limited studies have studied high plant-based protein diets. Thus we aim to investigate the~     effect of high protein diets in weight management and also to investigate the superior~     protein source in achieving this effect. In addition, we aim to develop dietary intervention~     strategies that are realistic and sustainable.~   "
239398|NCT00421603|"~     The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety~     and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence.~     Since both of these medications have independently shown promise in helping with cocaine~     abuse we are proposing that together they may be even more successful in the treatment of~     cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of~     the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine~     abstinence among cocaine-dependent patients. This study includes free treatment for cocaine~     dependence that includes medication.~   "
239399|NCT00421590|"~     This study will assess the effect of concomitant antacid on the pharmacokinetics and~     pharmacodynamics of SMC021~   "
239400|NCT00421577|"~     There is a simple laboratory technique for localization of caries associated bacteria on~     tooth surfaces by taking an impression of the teeth with a material containing sucrose.~      The purpose of this study is to check whether the technique can be incorporated into dental~     clinics as diagnostic tool comparing to other diagnostic methods available.~   "
239401|NCT00421564|"~     This study is to examine the effect and safety of the study drug,Danggui Buxue Tang, on~     menopausal symptoms of hot flushes and sweating and to determine whether the patient's~     quality of life will be improved.~   "
239402|NCT00421551|"~     The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able~     to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI~     + darunavir/r in HIV infected patients with full viral suppression.~   "
239403|NCT00421538|"~     CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to~     determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine)~     injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein~     thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks.~     Additionally, the study aims to determine if the 6 week course of treatment with~     therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency~     of post-thrombotic syndrome (PTS) at 1 year.~   "
239404|NCT00421525|"~     This is a Phase I/II, open-label, multi-center study conducted in patients with recurrent or~     refractory multiple myeloma who have failed at least two prior standard systemic treatments.~   "
239405|NCT00421512|"~     The purpose of this study is to test the safety of bevacizumab and sunitinib given in~     combination for kidney cancer. The drugs act to stop blood vessel growth but in different~     ways. They have not been studied together in a previous study. We also want to find out what~     effects (good and bad) the combination of bevacizumab and sunitinib have on you and your~     tumor.~   "
239406|NCT00421499|"~     Regular intake of cocoa-containing foods is linked to a considerably lower cardiovascular and~     all-cause mortality in observational studies. Short-term intervention studies indicate that~     high doses of cocoa improve endothelial function and reduce blood pressure (BP), but the~     clinical impact of long-term intake of small dietary amounts of cocoa on BP and the~     underlying BP lowering mechanisms are unclear. We hypothesized that cocoa consumption lowers~     blood pressure by augmentation of the circulating vasodilative nitric oxide (NO) pool due to~     the action of the cocoa polyphenols at the vascular endothelium.~      To test this hypothesis, we will conduct a randomized single-blind, parallel group study in~     subjects with mild essential hypertension to evaluate the effects of polyphenol-rich dark~     chocolate versus polyphenol-free white chocolate on blood pressure and plasma levels of cocoa~     phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress. After a~     7 day cocoa-free run-in period, 44 subjects will be 1:1 randomized to receive over 18 weeks~     daily doses of either dark chocolate (6.3 g per day with a total of 30 mg of polyphenols and~     30 kcal) or polyphenol free white chocolate (5.6 g per day with 30 kcal, containing similar~     amounts of macronutrients, electrolytes and vitamins). Subjects will be counseled to maintain~     an isocaloric diet and to abstain from other cocoa products during the study. Blood pressure~     and plasma parameters will be assessed in each subject after the run-in period and after 6,~     12, and 18 weeks of treatment.~   "
239407|NCT00421486|"~     Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases~     worldwide. HIV-infected men having sex with men /MSM) are strongly associated with a higher~     prevalence of genitoanal HPV-infection, and perianal HPV-infections have been detected in up~     to 90% of HIV-positive men. The data concerning the incidence of oral HPV-infection in~     HIV-positive men, especially in the era of highly antiretroviral therapy, are conflicting.~     Thus, this prospective study mainly focuses on the incidence and prevalence of oral~     HPV-infection, spectrum of HPV-types, and oral high-risk HPV viral load in HIV-positive men.~   "
239408|NCT00421473|"~     Malarone® (atovaquone/proguanil) is frequently used in malaria prophylaxis. Unfortunately,~     there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by~     induction of atovaquone metabolism.~      For travelling HIV patients, the clinical consequences of these possible drug drug~     interactions are serious, since a diminished exposure to the anti-malarial drug will result~     in suboptimal prophylaxis of malaria and potential development of drug resistant strains of~     Plasmodium falciparum.~      The purpose of this study is to find out if HIV patients using HAART regimes with either~     lopinavir/ritonavir, atazanavir/ritonavir or efavirenz have lower atovaquone plasma levels~     than healthy volunteers after a single dose of atovaquone/proguanil.~   "
239409|NCT00421460|"~     The purpose of this study is to evaluate the response of a treatment with testosterone~     undecanoate and determine the levels of total and free testosterone in hypogonadal patients~     with erectile dysfunction.~   "
239410|NCT00421447|"~     The primary objective of this study is to determine if trabecular or cortical volumetric bone~     mineral density (vBMD) change over time in postmenopausal breast cancer patients who are~     prescribed Anastrozole, as measured by pQCT at the proximal and distal radius and tibia.~   "
239411|NCT00421434|"~     The purpose of this study is to evaluate the safety and efficacy of~     nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens~     compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C~     genotype 4. The study will also evaluate the effect of the studied treatment regimens on end~     of treatment virologic response, ALT normalization and safety parameters.~   "
239412|NCT00421421|"~     The purpose of this study is to evaluate the efficacy and safety of dutasteride at reducing~     relapse rates of Acute Urinary Retention (AUR), including reduction in surgical intervention~     for benign prostatic hyperplasia (BPH), in patients who receive a 6 month treatment of~     dutasteride (0.5mg once daily) following a single episode of AUR followed by successful Trial~     Without Catheter compared with placebo.~   "
239413|NCT00421408|"~     Women and men consuming a low protein diet may be at risk for bone loss. The purpose of this~     study is to determine whether a daily protein supplement will improve bone health among~     healthy older adults.~   "
239414|NCT00421395|"~     This will be an open label, multiple center, non-randomized, dose-escalation Phase I/II~     trial, designed to evaluate the safety and effectiveness of a repeated, outpatient regimen~     utilizing IMMU-hLL2 intact monoclonal antibody IgG labeled with different doses of 90Y for~     the treatment of patients B-cell lymphoma (NHL).~   "
239415|NCT00421369|"~     In this project we aim to further refine indications for the use of the thyroid hormone - T3~     for patients suffering from depression. We aim to identify a sub-group of patients who are~     more likely to respond to T3 and establish the time in the treatment course when T3 should be~     added. The results of this project could have significant, direct clinical implications.~   "
239416|NCT00421356|"~     The Ossur Prosthetic Power Knee claims to assist in helping people with transfemoral~     amputation to walk up stairs and stand up from sitting. We expect to find that this product~     has the ability to help unload the sound knee during these tasks. We plan to collect force~     and motion data while people stand up from a chair. We will compare the data from people~     using several types of prosthetic knees, including the power knee as well as from people who~     are not amputees to see what the force and motion contributions are from the different knees~     evaluated.~   "
239417|NCT00421343|"~     The purpose of this study is to develop and implement an evidence based protocol for the~     secondary prevention of osteoporotic fractures and falls, and to determine how compliance~     with this intervention improves muscle strength and functional status following a fracture.~   "
239418|NCT00421330|"~     The purpose of this trial is to assess whether the new endovascular repair technique of the~     abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.~   "
239419|NCT00421317|"~     The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic~     ocular melanoma patients.~   "
239420|NCT00421304|"~     The primary objective of this study is to describe the effect of a single dose of medication~     compared to placebo in the upper respiratory tract in previously healthy children less than~     or equal to 12 months of age who are hospitalized with lower respiratory tract illness.~   "
239421|NCT00421291|"~     A lack of public awareness about entitled health and social services may contribute to poor~     delivery of services in developing countries. We sought to determine the impact of educating~     villagers about entitled services.~   "
239422|NCT00421278|"~     A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease~   "
239423|NCT00421265|"~     In patients with prostate cancer with indolent features, disease progrssion may be very slow~     and in many cases will never become clinically evident during the patient's lifetime. Active~     surveillance is a continuous process of monitoring disease characteristcs aiming to avoid the~     morbidity of active therapy in patients with stabe indolent parameters, while offering early~     detection of disease activity in others who will need active therapy to control their~     disease. We hypothesize that active surveillance will permit the avoidance of therapy related~     morbidity in the majority of appropriate patients and will be associated with maintaining~     their quality of life.~   "
239440|NCT00421044|"~     Patients who participated in the core EPO2121 study and did not clinically progress may~     participate in this extension protocol to further evaluate the safety, tolerability, and~     efficacy of patupilone.~   "
239441|NCT00421031|"~     The purpose of this study is to assess the efficacy and safety of 4 doses of~     desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of~     moderate to severe vasomotor symptoms associated with menopause, as well as its influence on~     sleep parameters and other health outcomes indicators.~   "
239424|NCT00421252|"~     Patients who have stents placed in their coronary arteries require treatment with at least~     two medications to prevent platelets from sticking to the stainless steel stent and forming a~     blood clot that can result in a heart attack. The 2 anti-platelet medications used for most~     patients with stents are aspirin and clopidogrel (Plavix). These are usually prescribed for~     1-12 months (the length of time depends on the number and types of stents implanted).~     Although the typical long-term dose of clopidogrel is 75 mg by mouth once daily, a larger~     dose (known as a loading dose) is usually given at the start of treatment to help the~     medication take effect more quickly.~      Prior to January 2006, most patients at the Beth Israel Deaconess Medical Center (BIDMC) who~     were undergoing PCI and who had not already been taking clopidogrel would receive a loading~     dose of 300-600 mg of clopidogrel in the cardiac catheterization procedure room immediately~     after the angioplasty and stenting portion of the procedure. However, several recent studies~     suggest that administering clopidogrel 600 mg at least two hours prior to an angioplasty~     procedure can reduce the rate of complications afterwards (especially reducing the chances of~     detectable damage to the heart muscle).~      The main purpose of this study is to see whether giving a loading dose of clopidogrel 600 mg~     to outpatients scheduled to undergo cardiac catheterization with coronary angiography can~     decrease the risk of procedure-related complications during the 14 days following the cardiac~     catheterization compared to a strategy of giving clopidogrel 600 mg after the procedure only~     to those who undergo angioplasty. We will focus our attention particularly on detecting~     damage to heart muscle following angioplasty (which might be expected to improve with a~     loading dose of clopidogrel before the procedure) and on bleeding and other groin~     complications (which might worsen with clopidogrel loading before the procedure).~      The drug clopidogrel has been approved by the Food and Drug Administration (FDA) for use in~     patients with a recent or ongoing heart attack, narrowings in major blood vessels outside the~     heart, or recent stroke with a loading dose of 300 mg followed by 75 mg once daily. It has~     been used in several large studies with a loading dose of 600 mg without a significant~     increase in major adverse effects. However, we do not yet know if it is useful or safe when~     given as a loading dose of 600 mg before cardiac catheterization for outpatients with stable~     symptoms and who are not thought to be in the midst of a heart attack.~   "
239425|NCT00421239|"~     The purpose of this study is to determine whether frequent hypertensive urgencies increase~     the risk of cardiovascular events in patients with arterial hypertension.~   "
239426|NCT00421226|"~     This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of~     ACZ885 administered via intravenous infusion and subcutaneous injection in healthy Japanese~     male volunteers.~   "
239427|NCT00421213|"~     The study of safety of a new organic arsenic compound in the treatment of hematological~     malignancies.~   "
239428|NCT00421200|"~     The purpose of this study is to determine whether Hemospan is superior to Voluven for~     preventing hypotensive episodes during the perioperative period (from induction of spinal~     anesthesia until 6 hours after skin closure), and for reducing the incidence of operative and~     postoperative complications including organ dysfunction and failure until follow-up at one~     month following surgery. An independent Data Safety Monitoring Board (DSMB) will periodically~     evaluate the safety data collected during this trial.~   "
239429|NCT00421187|"~     Administration of a single high dose (10 mg/kg) of AmBisome® no later than 72 hours after~     ARNF onset followed by two 5 mg/kg doses on days 2 and 5 may provide sustained tissue levels~     of amphotericin B that are as mycologically effective as those provided after administering~     the standard daily dose of 3 mg/kg/day. The new dosing regimen is anticipated to be equally~     clinically effective compared with the standard AmBisome® regimen when given for the duration~     of neutropenic fever in patients with ARNF. In addition, the degree and incidence of~     nephrotoxicity are predicted to be lower with the 3 sequential dose regimen compared to daily~     dosing with 3 mg/kg because of the lower cumulative dosage (20 mg/kg versus 42 mg/kg,~     respectively), which is 1 contributing factor for the development of acute renal failure.~     Furthermore, the lower cumulative dose may be a cost-effective strategy for the treatment of~     patients with ARNF.~   "
239430|NCT00421174|"~     The study is designed as a Phase III, multi-center randomized, double-blind,~     placebo-controlled trial investigating the use of etanercept for the treatment of acute,~     non-infectious pulmonary dysfunction (IPS) occurring after allogeneic hematopoietic cell~     transplantation (HCT).~   "
239431|NCT00421161|"~     Olive oil and Omega 3 have many anti inflammatory effects that may be beneficial in the~     inflammation and edema of chronic stasis dermatitis. The olive oil contains many mono~     unsaturated fatty acids and anti oxidants that may add to the well being of a diseased skin~     by improving cell membrane homeostasis.~   "
239432|NCT00421148|"~     The purpose of this study is:~        -  to explore the dose-response relation of sugammadex given as a reversal agent at~          reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult subjects~        -  to explore the pharmacokinetics of sugammadex in pediatric and adult subjects, and to~          evaluate the safety of sugammadex in pediatric and adult subjects.~   "
239433|NCT00421135|"~     The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced cancer.~   "
239434|NCT00421122|"~     This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD~     patients as defined by GOLD treatment guidelines in order to obtain an approval for~     indication of COPD from Chinese State Food and Drug Administration.~   "
239435|NCT00421109|"~     The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg~     Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic~     Idiopathic Urticaria.~   "
239436|NCT00421096|"~     The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin +~     radiotherapy followed by an adjuvant chemotherapy~   "
239437|NCT00421083|"~     This is a study of the efficacy and safety of on-demand dosing of tadalafil or placebo~     administered for 12 weeks to men with erectile dysfunction caused by spinal cord injury.~   "
239438|NCT00421070|"~     The purpose of this study is to investigate whether relaxation massage therapy is effective~     in reducing the levels of arousal and aggression on a young adult inpatient unit. It is~     hypothesised that relaxation massage therapy will lead to a lower incidence of violence and~     aggression on the ward via a reduction in the level of arousal and anxiety among inpatients.~   "
239439|NCT00421057|"~     Primary Objective:~      -Determine if a specific exercise regimen (combined strength training/functional endurance)~     reduces the level of fatigue among women with breast cancer while undergoing adjuvant or~     neoadjuvant chemotherapy treatment as compared to a control group.~      Secondary Objectives:~        -  Determine if a specific exercise regimen (combined strength training/functional~          endurance) increases the overall ability to perform daily physical activities (ADLs)~          among women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy~          treatment as compared to a control group.~        -  Determine if a specific exercise regimen (combined strength training/ functional~          endurance) increases mobility in women with breast cancer while undergoing adjuvant or~          neoadjuvant chemotherapy treatment as compared to a control group.~        -  Determine if a specific exercise regimen (combined strength training/functional~          endurance) increases endurance in women with breast cancer while undergoing adjuvant or~          neoadjuvant chemotherapy as compared to a control group.~   "
239447|NCT00420940|"~     This study will examine whether whole-body vibration slows down bone loss in healthy~     postmenopausal women with osteopenia. Whole-body vibration is a promising novel therapy that~     involves standing on a platform which produces extremely small and fast up-and-down~     movements. Some but not all research studies have found that whole-body vibration slowed down~     bone loss in postmenopausal women. One of the reasons why different studies found different~     results may be because they used various speeds of vibration. This study looks at how~     different speeds of whole-body vibration influence bone mineral density differently in~     postmenopausal women who have osteopenia. Two hundred postmenopausal women will take part in~     this 12-month study. Women will be randomly assigned into three groups (67 women per group)~     and these groups will be compared. Group 1 will receive very fast whole-body vibration, Group~     2 will receive fast whole-body vibration, and Group 3 will not receive whole-body vibration.~     We will look at various bone mineral density and bone quality measurements, obtained with~     three different types of technologies, at the beginning of the study and at 12 months of~     follow-up. The hypothesis of this study is that the in comparison to Group 3 (no vibration),~     Groups 1 and 2 will experience reduced bone loss over 12 months, and that the greatest~     reduction in bone loss will be experienced by Group 1. The results of this study will help us~     determine whether whole-body vibration at different speeds produces variable effects on bone,~     hence explaining the inconsistency of the results obtained in previous studies.~   "
239448|NCT00420927|"~     This study compared the safety and efficacy of combination therapy with adalimumab plus~     methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early~     rheumatoid arthritis (RA).~   "
239449|NCT00420914|"~     To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a~     standard dose platelet transfusion strategy.~   "
239450|NCT00420901|"~     chronic PDE5-Inhibition improves endothelial function in diabetics~   "
239451|NCT00420888|"~     The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes~     tumor cells and one that triggers an attack on the tumor cells by activating some white blood~     cells belonging to the body's normal immune system. This results in an accumulation of white~     blood cells in the cancer that can fight the cancer. This study will compare the safety and~     effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox~     when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal~     cell carcinoma (RCC).~   "
239452|NCT00420875|"~     To determine the magnitude of improvement for pain and function symptoms over a two year~     period after enrollment into the registry study in patients presenting with chronic heel pain~     and receiving standard of care treatment. Standard of care will include traditional~     conservative care measures, ESWT, radiofrequency-based plasma microdebridement, scalpel~     debridement and/or surgical release.~   "
239453|NCT00420862|"~     High survival rates have been reported for screen-detected Stage I lung cancer patients, but~     there are concerns about the potential biases of uncontrolled studies. DANTE is a prospective~     randomized controlled trial exploring the effects of screening with LDCT on~     lung-cancer-specific mortality, and on the prevalence and incidence rates of lung cancer,~     stage distribution and resectability rates in a selected high-risk population. The prevalence~     of a set of biomarkers in sputum and blood samples is also being determined.~   "
239454|NCT00420849|"~     This is a multi-centre, single-arm treatment study combining lenalidomide plus high dose~     dexamethasone.~      Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone~     in 4 week cycles. Subjects will be seen every 2 weeks for the first 3 cycles of therapy and~     then every 4 weeks after the third cycle until disease progression is documented, study drug~     is discontinued for any reason or lenalidomide becomes commercially available for this~     indication. Assessments of safety and quality of life are performed during the study.~   "
239455|NCT00420836|"~     This study assesses the aerosol delivery characteristics (measured by nebulization time,~     serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered~     for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet~     Nebulizer (with compressor) in subjects with cystic fibrosis.~   "
239456|NCT00420823|"~     The purpose of this study is to determine whether Taurine 4g is effective with antipsychotic~     medication in the treatment of First Episode Psychosis.Taurine may have an effect on~     cognition and symptoms. We are examining changes in symptoms and cognition over a 3 month~     period.~   "
239457|NCT00420810|"~     The purpose of this study is determine whether this drug will improve your insomnia in terms~     of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will~     be compared against placebo in order to determine if there's a difference.~   "
239458|NCT00420797|"~     The aim of the study is to test the hypothesis that topical application of phenylephrine~     improves faecal continence and quality of life in subjects with passive faecal incontinence~     after ileo-anal pouch construction.~   "
239459|NCT00420784|"~     The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an~     investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a~     (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1~     hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment~     of interferon therapy.~   "
239477|NCT00420550|"~     Interstitial cystitis (IC) affects more than one million women in the United States. It has~     been thought that IC patients who have been unable to obtain adequate relief from medical~     remedies would value a psychotherapeutic intervention that could diminish some of their pain.~      There are currently no studies using biomarkers with the use of a relaxation technique called~     guided imagery in IC patients. Many guided imagery intervention studies in areas such as~     cancer, post-operative pain, and arthritis reported that guided imagery resulted in~     improvements in the psychological or physiological outcomes examined. If this is also true in~     IC patients, this intervention may prevent the use of unnecessary medications and procedures~     that are currently being used.~   "
239478|NCT00420537|"~     The purpose of this study is to verify if the combination of Everolimus with a very low dose~     of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose~     of cyclosporine in reducing the progression of kidney dysfunction in patients with heart~     transplantation.~   "
239460|NCT00420771|"~     The aim of this project is to study the use of gabapentin in reducing benzodiazepine abuse in~     methadone maintenance patients. A second aim is to study the effects of gabapentin on~     craving, mood, anxiety, and sleep disturbance in methadone maintenance patients abusing~     benzodiazepines. The proposed protocol is a randomized, double-blind, placebo-controlled~     pilot outpatient trial of gabapentin in the treatment of benzodiazepine abuse in methadone~     maintenance patients. All subjects will receive weekly manual-guided psychotherapy directed~     at achieving abstinence and improving current functioning. The primary outcome measure,~     benzodiazepine use, will be assessed weekly by a combination of self-report (time line~     follow-back method) and urine toxicology. Associated psychological symptoms of craving, mood,~     anxiety, and sleep disturbance, will be assessed by a combination of clinician and self-rated~     instruments.~      The investigators hypothesize that individuals receiving methadone maintenance treatment who~     are abusing (nonprescribed use) benzodiazepines have difficulty in reducing or discontinuing~     benzodiazepine use because of the significant anxiety, mood, and sleep disturbance symptoms~     that accompany reduction in use. Gabapentin, an anticonvulsant which has anxiolytic and~     sedating properties, may alleviate the symptoms associated with a reduction in benzodiazepine~     abuse and make the achievement of abstinence more likely when administered in the setting of~     an active psychotherapy condition.~   "
239461|NCT00420758|"~     This study tests the hypothesis that moderately underweight but not severely wasted~     6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for~     12 weeks grow better during the supplementation than infants who do not get any food~     supplement.~   "
239462|NCT00420745|"~     This study is planned to evaluate the safety (in terms of occurrence of any serious adverse~     events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to~     develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants~     aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and~     in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study~     will be performed in four European countries (France, Poland, Spain, and Portugal). The~     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
239463|NCT00420732|"~     To determine the response rate of the administration of HyperAcute-Lung Cancer Vaccine for~     subjects with stage IIIB or stage IV non-small cell lung cancer who have been treated with~     first line platinum-doublet therapy and have responded or are considered to have stable~     disease.~   "
239464|NCT00420719|"~     The overall goal of this research is to delay the respiratory decline of patients with~     Amyotrophic Lateral Sclerosis (ALS) thereby increasing their lifespan by conditioning the~     diaphragm with laparoscopically placed electrodes.~      This device currently holds an Investigational Device Exemption No. G040142 in the United~     States and is currently undergoing clinical trials at University Hospitals (Cleveland), Johns~     Hopkins, Mayo Clinic Jacksonville, California Pacific Medical Center (CPMC), Henry Ford~     Health System, The Methodist Hospital, and Stanford University.~   "
239465|NCT00420706|"~     To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by~     increasing dose amounts in a step-wise fashion.~   "
239466|NCT00420693|"~     The objective of this randomized and controlled study is to compare the sedation with~     sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate~     peripheral inserted central catheter insertion in a pediatric and neonatal intensive care.~     Main measurements concern success or failure of insertion, duration of procedure, movements~     of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate,~     respiratory frequency and oxygen saturation.~   "
239467|NCT00420680|"~     The purpose of this study is to evaluate the safety of 2.0 mg/kg and 4.0 mg/kg sugammadex~     given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium in cardiac~     patients~   "
239468|NCT00420667|"~     Because the impairment of platelet function may cause excess peri-operative bleeding,~     pre-operative aspirin discontinuation and heparin bridging are common at cardiac surgery. We~     aimed to evaluate the impact of a low-molecular-weight-heparin (LMWH), enoxaparin, and~     unfractionated heparin (UFH) on coagulation parameters and peri-operative bleeding in~     patients undergoing elective coronary artery bypass grafting (CABG) surgery after aspirin~     discontinuation.~      The specific hypothesis of this study was that a 12 h interval is sufficient not to cause~     excess peri-operative bleeding, and is therefore an optimal compromise between antithrombotic~     efficacy and haemorrhagic safety.~   "
239469|NCT00420654|"~     Growth hormone treatment is used in girls with Turner syndrome to increase final height. The~     aim of this study is to evaluate the effect of growth hormone treatment on body composition~     and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass~     will decrease and lean body mass will increase. There is only very limited documentation of~     the effect on the heart in this study population.~   "
239470|NCT00420641|"~     To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the~     treatment of outpatients subjects with major depressive disorder to exhibit decreased~     pleasure, interest and energy.~   "
239471|NCT00420628|"~     A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in~     children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)~   "
239472|NCT00420615|"~     The purpose of this study is to evaluate the potential inhibitory effects of patupilone on~     metabolism using midazolam and omeprazole as the respective probe drugs.~   "
239473|NCT00420602|"~     We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids~     such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3~     patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement~     their diets with DHA/EPA.~   "
239474|NCT00420589|"~     To compare the effects of taranabant versus placebo on weight regain and weight maintenance~     after low calorie diet-induced weight loss in obese patients.~   "
239475|NCT00420576|"~     Main purpose of the study is to look for an optimal dose for the treatment of menopausal~     symptoms with the Chinese Herbal Medicines containing Dang Gui and Huang Qi.~   "
239476|NCT00420563|"~     The scope of the trial is to assess the free progression rate at 2 months for each group of~     patients.~   "
241409|NCT00394810|"~     This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and~     pharmacokinetics, of Panzem® NCD in patients with metastatic, docetaxel refractory,~     androgen-independent prostate cancer.~   "
239479|NCT00420524|"~     This phase I study will determine the pharmacokinetic profile of patupilone in patients with~     mild or moderately impaired hepatic function within 2 cycles of treatment. The study~     population for this trial consists of patients with a documented advanced solid tumor.~     Patients will be stratified into 3 groups: those with normal liver function, and those with~     mild or moderate liver dysfunction.~   "
239480|NCT00420511|"~     Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive~     deterioration in the function of the pancreatic beta-cells, which are the cells that produce~     and secrete insulin (the hormone primarily responsible for the handling of glucose in the~     body). The investigators propose a double-blind, randomized controlled pilot study comparing~     the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential)~     versus placebo, on the preservation of beta-cell function over one year in patients with T2DM~     on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be~     (i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate~     an important beta-cell protective capacity of sitagliptin.~      Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor~     sitagliptin will preserve pancreatic beta-cell function.~   "
239481|NCT00420498|"~     The purpose of this study is to examine the effects of atomoxetine (Strattera™) on prefrontal~     cognitive functioning in persons with schizophrenia. Secondarily, the effects of atomoxetine~     on positive and negative symptoms and on cigarette smoking consumption in persons with~     schizophrenia will be examined.~   "
239482|NCT00420485|"~     This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan~     administered orally in patients with advanced solid tumors~   "
239483|NCT00420472|"~     This study will assess the safety, efficacy and effect on quality of life of switching kidney~     transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a~     higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS~     (<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the~     CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4~     doses. The anticipated time on study treatment is <3 months, and the target sample size is~     <100 individuals.~   "
239484|NCT00420459|"~     The purpose of this study is to determine the effectiveness and tolerability of aripiprazole~     in the treatment of children and adolescents with Fragile X Syndrome.~   "
239485|NCT00420446|"~     The purpose of the project is to elucidate the effect on blood pressure by daily intake of~     dairy products. Previous studies have demonstrated a beneficial effect on blood pressure.~      In total 90 subjects will be enrolled. For eight weeks, the participants will ingest one of~     two different dairy produces. Before, during and after the study period, the blood pressure~     is measured.~   "
239486|NCT00420433|"~     Primary Objectives:~        -  To estimate and compare the sensitivity and specificity of computed tomography (CT),~          plain radiography (XR), and skeletal scintigraphy (SS) with each other for the~          assessment of response of bone metastasis in patients with breast cancer.~        -  To estimate and compare the sensitivity and specificity of M. D. Anderson (MDACC) bone~          metastasis criteria with that of current criteria (UICC, WHO) in breast cancer patients~          for the assessment of the behavior of osseous metastasis in breast cancer patients.~      Secondary Objective:~        -  To evaluate the progression free survival (PFS) and overall survival (OS) of each~          response group (CR, PR, SD, PD) assessed by imaging and response criteria.~   "
239487|NCT00420420|"~     The purpose of this study is to test the efficacy and safety of an investigational medication~     for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication~     or placebo for 28 days. Tests of memory, concentration will be included. Safety will be~     monitored using routine clinical and laboratory tests.~   "
239488|NCT00420407|"~     Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of~     resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and~     mortality in critically ill patients following trauma.~   "
239489|NCT00420394|"~     Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for~     adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in~     locally advanced gastric cancer results in significant tumoral downstaging with improved rate~     of curative resections.~      Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and~     postoperative chemoradiation for locally advanced adenocarcinoma of stomach and~     gastroesophageal cancer~   "
239490|NCT00420381|"~     The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in~     patients with recurrent or persistent ovarian cancer.~   "
239491|NCT00420368|"~     This study tests the hypothesis that moderately underweight but not severely wasted~     6-17-month old infants receiving fortified spread or maize-soy flour as a food supplement for~     12 weeks grow better during the supplementation than infants who do not get any food~     supplement.~   "
239492|NCT00420355|"~     The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and~     atazanavir when lopinavir/ritonavir and atazanavir are used in combination.~   "
239493|NCT00420342|"~     The main purpose of this study is to compare the effects of treatment of two different~     formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with~     prehypertension.~   "
239494|NCT00420316|"~     To assess the long-term efficacy and safety of the subjects during the third year after~     priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the~     primary vaccination study (102247). The Rotarix vaccine was administered in the primary~     vaccination study. There was no vaccine/intervention in this long-term efficacy study.~   "
239495|NCT00420303|"~     To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and~     refractory heel enthesitis.~   "
239510|NCT00420108|"~     The objective of this study is to evaluate whether the heart rate variability, daily heart~     rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in~     conjunction with other traditional clinical practice methods to determine if heart failure~     patients are ready for hospital discharge.~   "
239511|NCT00420095|"~     The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with~     type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin~     30/70.~   "
239496|NCT00420290|"~     Chronic hemodialysis (CHD) patients display multiple metabolic abnormalities related to~     advanced uremia. Despite vigorous attempts to prevent these abnormalities and their~     consequences, most CHD patients suffer from a unique form of nutritional derangement, which~     can be termed as uremic wasting. Several studies have demonstrated that the presence of~     uremic wasting, especially the degree of loss of muscle mass, sharply increases mortality and~     hospitalization rate in CHD patients.~      Several factors have been thought to be associated with uremic wasting, including hormonal~     derangement, anorexia, physical inactivity, and concurrent illnesses. Chronic inflammation,~     also highly prevalent in these patients, causes muscle catabolism in animal models and~     certain clinical conditions. Epidemiological studies show an association between chronic~     inflammation and uremic wasting in hemodialysis patients indicating a possible causal~     relationship.~      The cause for the activated inflammatory state in CHD patients is believed to be~     multi-factorial. Nevertheless, it is certainly important for the host to limit its biological~     activity by eliciting a stronger anti-inflammatory response, for example through the~     production of naturally occurring receptor antagonist. Interleukin 1 beta, one of the major~     pro-inflammatory cytokines has been shown to be associated with protein catabolism in several~     chronic disease states, including advanced uremia. A balance between interleukin 1 beta~     (agonist) and its naturally occurring receptor antagonist IL-1ra may play a pivotal role in~     controlling the inflammatory response and its consequences in this population.~      The overall goal of this particular grant application is to examine the short-term effects of~     the administration of the recombinant form of IL-1ra on 1) chronic inflammatory state and 2)~     protein homeostasis in chronically inflamed CHD patients.~      We have updated our protocol to perform an interim analysis. The interim analysis will be~     performed after half of the planned study sample has been enrolled (14 subjects; 7 in each~     arm). The interim analysis has been approved by the Data Safety Monitoring Board.~   "
239497|NCT00420277|"~     The purpose of this study is to determine whether Hemospan is superior to Voluven for~     treatment of hypotensive episodes during the perioperative period (from induction of spinal~     anesthesia until 6 hours after skin closure), and for reducing the incidence of operative and~     postoperative complications including organ dysfunction and failure until follow-up at one~     month following surgery. An independent Data Safety Monitoring Board (DSMB) will periodically~     evaluate the safety data collected during this trial~   "
239498|NCT00420264|"~     Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can~     be tolerated in the office setting without the use of intravenous medication.~   "
239499|NCT00420251|"~     Growth retardation is well known in patients with severe forms of juvenile idiopathic~     arthritis. Especially those who were under additional treatment with glucocorticoids for high~     disease activity. The hypothesis is, that treatment with growth hormone can, at leat in part,~     overcome growth hormone resistance state and increase final height. In a controlled study we~     follow patients with juvenile idiopathic arthritis with and without growth hormone treatment~     until final height. Additionally, we are interested in bone density development in those~     treated with growth hormone.~   "
239500|NCT00420238|"~     Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe~     and advanced ankylosing spondylitis.~   "
239501|NCT00420225|"~     The purpose of this study is to determine whether reenforcement with polypropylen mesh~     compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in~     fewer recurrences.~   "
239502|NCT00420212|"~     To determine if treatment with BG00012 can decrease the number of MS relapses during a~     certain time period. To determine if, over time, BG00012 treatment can decrease the number of~     certain types of brain lesions commonly seen in MS patients and slow down the time it takes~     for the disease to get worse.~      The purpose of this study is also to determine the safety of BG00012 and how well it is~     tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used~     to assess MS.~   "
239503|NCT00420199|"~     The only trial in participants who are methotrexate-inadequate responders and have active~     Rheumatoid Arthritis, in which gadolinium-enhanced Magnetic Resonance Imaging; Bone Mineral~     Density; and biochemical markers of bone, cartilage, and synovial tissue metabolism are used~     to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study~     will provide valuable mechanism-of-action information on how Abatacept exerts its effects~     (including on bone) through new techniques.~   "
239504|NCT00420186|"~     The purpose of this clinical research is to assess the safety and tolerability of BMS-690514~     when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be~     administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given~     in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An~     additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with~     Paclitaxel and carboplatin~   "
239505|NCT00420173|"~     Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical~     manifestations and a variable prognosis. The aim of this study is to create a standardized~     evaluation of the different subtypes of this disease in order to receive an overview of the~     spectrum of clinical and laboratory features as well as the therapeutic strategies for~     patients with CLE.~   "
239506|NCT00420160|"~     This study compares the effects of a standard smoking cessation treatment, including one-time~     brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise~     program versus the same standard smoking cessation treatment plus equivalent contact control~     among 60 healthy women. We hypothesize that participants in the smoking cessation plus~     moderate intensity exercise condition will be more likely to quit smoking than participants~     in the smoking cessation treament plus contact control condition.~   "
239507|NCT00420147|"~     The five-year goal of this project is to investigate the effect of in-shoe wedged orthoses on~     lower extremity function in patients with knee osteoarthritis. In general, our aims address~     the long-term effects of orthoses. The investigators hypothesize that subjects who use the~     lateral wedged in shoe orthosis will result in altered gait mechanics that reflect a~     reduction in the frontal plane knee joint moment compared to subjects who use a neutral in~     shoe orthosis.~   "
239508|NCT00420134|"~     The methods for separation of mesenchymal stem cell were established in 2001. These cells can~     differentiate to osteocytes, hepatocytes, chondrocytes, myocytes and etc,. In this study the~     investigators try to separate mesenchymal stem cell from end stage liver disease, then these~     cells will be differentiated to progenitor of hepatocytes, finally , the investigators~     injected these cells into portal vein under ultrasound guide. The investigators determine the~     effects of injected cells in reestablishment of liver function.~   "
239509|NCT00420121|"~     Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical~     manifestations and a variable prognosis. The aim of the study is to create a standardized~     evaluation of the different subtypes of this disease in order to receive an overview of the~     spectrum of clinical and laboratory features as well as the therapeutic strategies for~     patients with CLE.~   "
239513|NCT00420069|"~     The MRTX portable lightweight respirator (MRTX) provides noninvasive respiratory support~     using biphasic extrathoracic ventilation via a cuirass fitted around the patient's chest.The~     aim of the study is to evaluate the efficacy of the MRTX during dental treatment under deep~     sedation in comparison with the conventional treatment where children are only under monitor~     and only intervention is done when required.Twenty healthy children (ASA1) will wear the~     cuirass. PO2 saturation and ETCO2 will be recorded as a baseline. Half of the children will~     be ventilated (with similar values to those of physiologic respiration) and the other half~     will notThe study is blind, since the anesthesiologist and the dentist would not know if the~     cuirass of the child is connected to the MRTX or not:~      Group 1- 10 children with the cuirass will be connected to the MRTX and artificially~     ventilated at pressures of (-12/+5) at a rate of 20 per minute, and PO2 and ETCO2 will be~     recorded every 5 minutes.~      Group 2- 10 children with the cuirass will not be connected to the MRTX, but the machine will~     work at the same condition. Same records of PO2 and ETCO2 will be registered.~   "
239514|NCT00420056|"~     This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is~     also known as a PET scan. This study will assess the safety of using PD-0332991 in patients~     with mantle cell lymphoma.~   "
239515|NCT00420043|"~     This study will evaluate the effect of food on the relative bioavailability of a single dose~     of imatinib given as a 800 mg modified release tablet, compared to twice-daily doses of 400~     mg film-coated tablets. There will be a 8 day wash out phase between treatments and a 1 week~     safety period at the end of the study. Each participant will receive all four treatments.~   "
239516|NCT00420030|"~     Outcome of patients with myocardial infarction complicated with cardiogenic shock is very~     poor. Although early mechanical revascularization has been demonstrated superior to~     conservative medical treatment, mortality range remains about 45-60%. Some medical registries~     have showed further therapeutic benefit by administration of glycoprotein (GP) IIb/IIIa~     inhibitors during PCI in patients with cardiogenic shock. However, there is no randomized~     study that supports this therapeutic strategy in these high risk patients.~      Hypothesis:~      GP IIb/IIIa inhibitors improve angiographic (TIMI-flow), echocardiographic (LV function) and~     clinical (combined end-point) outcomes in patients with myocardial infarction complicated~     with cardiogenic shock.~      Study design:~      Open pseudorandomized multicenter, phase IV clinical trial.~      Anticipated findings:~      The investigators anticipate to document better angiographic, echocardiographic and clinical~     outcome after upfront abciximab administration in comparison to standard periprocedural~     therapy in patients undergoing PCI for cardiogenic shock. This would be the first randomized~     clinical trial that could support this therapeutic strategy.~   "
239517|NCT00420017|"~     The investigators hypothesize that the medication amiodarone decreases the incidence of~     atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:~      Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy~     surgery; Determine the influence of the prevention of AF following esophagectomy surgery on~     post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical~     hospital stay; and Determine the safety of amiodarone for the prevention of AF following~     esophagectomy surgery.~   "
239518|NCT00420004|"~     This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in~     treating adults with major depressive disorder.~   "
239519|NCT00419991|"~     Tigecycline is being developed as an agent that overcomes tetracycline-resistance mechanisms~     and provides activity against emerging multi-drug resistant pathogens. The purpose of this~     protocol is to determine the linkage between time related clinical measures of infection~     response and time to bacterial eradication in patients with intravascular catheter infections~     caused by Staphylococcus epidermidis and other coagulase negative staphylococci.~   "
239520|NCT00419978|"~     This study is for the patient with colon cancer, who is going to have colon cancer surgery.~     The purpose of this research study is to examine a specific lymph node, called the sentinel~     node. Lymph nodes are located throughout your body and cancer may spread by means of those~     lymph nodes. The sentinel node is the one located closest to your tumor. This study will find~     out if examining the sentinel node can help to predict disease progression. Since the value~     of this exam is unknown, taking part in this study will not change your clinical care.~   "
239521|NCT00419965|"~     The primary objective of this study is to determine the utility of GRK2 to differentiate~     between normal patients and patient groups that differ by the presence/absence of HF~     symptoms, systolic or diastolic left ventricular dysfunction, and risk factors; and to~     evaluate if a new assay provides similar values as traditional methods for measuring GRK2~     levels.~   "
239522|NCT00419952|"~     The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a~     medication approved by the Food and Drug Administration, FDA) in the African American~     population.~   "
239523|NCT00419939|"~     The aim of the study is to develop a research-based pedagogic model to improve the~     interaction between the patient`s motivation, influence and learning.The hypothesis is:~      A neuro-rehabilitation effort in patients with severe traumatic brain injury based on a~     didactic model for improvement of motivation, involvement and re-learning of daily life~     competences will~        -  improve the patients experience of meaningful learning and influence~        -  provide staff with a tool which contributes to the experience to work in a targeted way~          concerning motivation, patient influence and re-learning daily life competencies~      The aim of the study is to develop a research-based didactic model to improve the interaction~     between the patient`s motivation, influence and learning.~   "
239524|NCT00419926|"~     The purpose of this study is to determine if an initial intensified enteric-coated~     mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post~     renal transplantation provides improved efficacy, with a similar safety profile, compared to~     a standard regimen of Myfortic.~   "
239525|NCT00419913|"~     Our long term goal is to elucidate the role of DHEA on follicular dynamics in the human ovary~     and to better understand the interaction of DHEA supplementation with other treatments for~     ovulation induction, especially among older reproductive age women.~      The specific hypothesis behind the proposed research is that DHEA is a regulator of~     follicular dynamics acting in the early pre-gonadotropin dependent stage of initial~     primordial follicle recruitment and growth.~   "
239526|NCT00419900|"~     Using synchrotron X-ray diffraction, it has been reported that a hair from an individual with~     breast cancer exhibits a difference in its molecular structure compared to that of an~     individual without breast cancer. This difference is visible in the X-ray diffraction pattern~     as a ring superimposed on the pattern for normal hair.~      The hypothesis of this study is that synchrotron x-ray diffraction can be used to~     differentiate hairs from women with medically diagnosed breast cancer from women not known to~     have the disease.~      To test this hypothesis, hair from 2000 women attending radiology clinics for mammography~     will be collected, analysed by x-ray diffraction and then analysed using Fermiscan~     proprietary image analysis software. The mammogram status of the subjects will be blinded~     from the diffraction analysts. Results will then be compared with mammography results to~     allow a direct comparison between the Fermiscan test and mammography in terms of specificity~     and sensitivity.~   "
239527|NCT00419887|"~     The purpose of this study is to assess the safety, tolerability, effect of vildagliptin and~     how the body changes the blood level of vildagliptin of single and multiple oral doses of~     vildagliptin in healthy Chinese volunteers.~   "
239528|NCT00419874|"~     The main goal of the present study is to challenge the hypothesis that blood- brain barrier~     disruption following brain injury increases the risk for long-term disability, development of~     brain dysfunction, epileptic seizures and neuroanatomical alterations.~   "
239529|NCT00419861|"~     Influenza vaccination is recommended for all persons age 65 and older. Vaccines that are~     designed and tested in young healthy adults are often not as effective when used in the~     elderly. This study will be a one year pilot study to see if it would be practical to conduct~     a larger study at several other hospitals in the future. Study participants will include 350~     men and women greater than or equal to age 50 that are hospitalized at Vanderbilt University~     or Baptist Community Hospital with acute respiratory symptoms. Study procedures will include~     questions, one nasal swab, one throat swab, and chart reviews after the patient has been~     released from the hospital. The nasal and throat swabs will be tested for influenza A and B~     viruses.~   "
239530|NCT00419848|"~     a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin~     in the management of moderate acne vulgaris~   "
239531|NCT00419835|"~     Chronic kidney disease (CKD)has become a significant health problem worldwide. Strategies to~     decrease the rate of progression of this disease and reduce the number of patients needing~     dialysis or renal transplantation are urgently needed. In this study we wish to compare the~     effect of dual blockade of renin-angiotensin system (ACE inhibitors plus angiotensin II~     receptor blocker) compared to the effect of ACE inhibitor monotherapy in patients with~     diabetic chronic nephropathy.~   "
239532|NCT00419822|"~     This study is for the woman who will have axillary (armpit) surgery as part of their breast~     cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to~     control pain and improve range of motion (arm movement). Another goal is to find out if women~     have an improvement in their quality of life. This study is being done in collaboration with~     the Oregon College of Oriental Medicine (OCOM).~   "
239533|NCT00419809|"~     SB-681323 is a p38 MAP-kinase inhibitor that has potential uses in inflammatory conditions~     such as RA. Previous p38 MAP-kinase inhibitors have been hindered in development by liver~     toxicity. Methotrexate (common treatment for RA patients) also has potential liver toxicity.~     This study was an enabling study to determine the safety of co-administration of the two~     compounds with respect to liver function~   "
239534|NCT00419796|"~     This randomized study will compare the effect of lumiracoxib, ibuprofen and placebo on~     24-hour blood pressure profile and on urinary excretions of eicosanoids in controlled~     hypertensive patients who have osteoarthritis.~   "
239535|NCT00419783|"~     The purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg)~     compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and~     placebo. Subjects will receive each of the five study treatments in a crossover fashion~     administered once daily for 4 days.~   "
239536|NCT00419770|"~     The purpose of this study is to determine if the addition of the medication, deferasirox, to~     standard antifungal therapy for the infection, mucormycosis, is safe and effective~   "
239537|NCT00419757|"~     The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a~     medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.~   "
239538|NCT00419744|"~     The purpose of this study is to determine if SYMBICORT® delivered via a pressurized~     metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.~   "
239539|NCT00419731|"~     The purpose of this study is to compare the effects of bupropion + placebo to bupropion +~     naltrexone as treatments to help smokers quit.~   "
239540|NCT00419718|"~     The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of~     exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with~     type 1 diabetes.~   "
239541|NCT00419705|"~     The purpose of this pivotal study is to demonstrate safety and effectiveness of the~     NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects~     diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for~     each Subject within 24 hours of stroke onset.~   "
239542|NCT00419692|"~     This study in RLS patients is designed to assess the affect food has on the absorption,~     distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted~     state and other patients following a high-fat breakfast), and to assess the difference in~     absorption, distribution, metabolism and excretion of ropinirole if patients are given two~     3mg ropinirole tablets versus one 6mg tablet.~   "
239543|NCT00419679|"~     Study FT3.6k-2006 is a single centre (the Mater Hospital, Sydney), blinded trial of a~     diagnostic test for breast cancer, with outcomes compared to the gold standard of screening~     mammogram followed by biopsy where required. This study aims to perform X-ray diffraction~     analysis of coded hair samples from women with a documented breast health status, to validate~     the findings of James et al (Nature 398: 33-4, 1999; Int J Cancer 114: 969-72, 2005) who~     showed that the presence of breast cancer could be detected using synchrotron-derived x-ray~     diffraction of human hair (scalp or pubic). The aim is also to characterise the sensitivity~     and specificity of the hair test in detecting breast cancer in a screening setting, and to~     determine the significance of a positive hair test and a negative mammogram.~   "
239544|NCT00419666|"~     This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the~     adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied~     twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous~     areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will~     be collected during the first 3 weeks of the study; safety and efficacy data will be~     collected for the 8 weeks of the treatment.~   "
239545|NCT00419653|"~     The study aims to investigate the modulation of regional brain activation in schizophrenic~     patients by psychopharmacological treatment with either haloperidol, amisulpride or~     olanzapine. The study will be performed with functional magnetic resonance imaging (fMRI) and~     diffusion tensor imaging (DTI).~   "
239546|NCT00419640|"~     This is a randomized, parallel, single-blinded multi-center study. The objective is to~     compare the long term clinical outcomes among the site of atrial pacing and to compare the~     long term effect of the atrial fibrillation (AF) Suppression algorithm.~   "
239547|NCT00419627|"~     The purpose of this study is to evaluate the presence of proteins in solid tumors which may~     lead to an immune response~   "
239548|NCT00419614|"~     Chart review evaluating outcome of patients in whom following resection of a tumor involving~     the head of the pancreas no anastomosis of the pancreatic stump was done to the~     gastrointestinal tract.~   "
239549|NCT00419601|"~     It shall be investigated whether ventilated neonates and infants with a remifentanyl based~     analgesia and sedation can be extubated faster after discontinuation of the opioid infusion~     compared to neonates and infants with a fentanyl based analgesia and sedation.~   "
239550|NCT00419588|"~     The purpose of this study is to evaluate the growth of the lung and how easily gas can be~     taken up by the lung in healthy infants born at full term without any breathing problems and~     infants born prematurely.~   "
239551|NCT00419575|"~     The aim of this observational study is to evaluate an FDA approved immune system monitoring~     assay (Immunknow, Cylex Inc. Columbia, MD) in renal transplant recipients using standard~     immunosuppression and prophylaxis protocols from the time of transplantation through a twelve~     month follow-up period. The primary endpoint will be the incidence of acute rejection and~     infection and any correlation of these events to an assay that may be a measure of recipient~     immune response. Secondary endpoints will include evaluation of renal function, patient and~     graft survival, incidence of post-transplantation lymphoproliferative disorder and duration~     and extent of lymphocyte depletion.~   "
239552|NCT00419562|"~     Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part~     of the body which helps fight infections) mistakenly attacks and destroys the cells that~     produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's~     ability to produce insulin decreases. There is evidence suggesting that repeated oral~     administration of an autoantigen (the same protein that the immune system is reacting to) may~     introduce a protective immunity and cause the immune system to stop its attack. An earlier,~     large scale study was done to see if oral insulin could delay or prevent the development of~     Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results~     showed that for the entire study population, oral insulin did not delay or prevent Type 1~     diabetes. However, an analysis that was done after the conclusion of the trial suggested a~     potential beneficial effect in a subgroup of participants. The participants who seemed to~     benefit from oral insulin had higher levels of insulin autoantibodies which are directed~     against insulin itself ( called mIAA).~      The Type 1 Diabetes TrialNet study group will further explore the potential role of oral~     insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also~     include a secondary group of individuals at different levels of risk than those in the~     primary cohort to gather information for future studies.~   "
239553|NCT00419549|"~     ERCP is a diagnostic and therapeutic procedure that is required in patients with suspected~     common bile duct stone, malignant biliary obstruction, biliary fistula, etc. Pancreatitis may~     occur as a complication of this procedure after about 5-10% of the ERCP procedures. This~     complication manifests as persisting pain 24 hours or more after ERCP, along with raised~     levels of pancreatic enzymes in the blood. Most of the cases of post-ERCP pancreatitis are~     mild, but may be severe and lead to prolonged hospitalization a few patients. The occurrence~     of this complication is unpredictable. There have been a number of attempts to prevent this~     complication. These include giving certain drugs before ERCP e.g. octreotide, somatostatin,~     steroids, etc. However, these have not been successful. Recently, a study showed that~     application of glyceryl trinitrate patch on the skin before ERCP might reduce the incidence~     of post ERCP-pancreatitis. Another study showed that per rectal administration of diclofenac~     tablet after the ERCP procedure also reduced occurrence of post ERCP pancreatitis. Other~     experimental studies have shown that certain anti-inflammatory drugs like cox-2 inhibitors~     may also be effective.~      The investigators want to study whether transdermal patch of glyceryl trinitrate or~     administration of injectable cox-2 inhibitor Valdecoxib (pro-drug Parecoxib) can prevent~     post-ERCP pancreatitis in our patients who undergo an ERCP.~   "
239554|NCT00419536|"~     This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single~     agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to~     characterize the safety, tolerability, biologic activity and pharmacokinetic profile.~   "
239555|NCT00419510|"~     The objectives of this study are to develop a Culturally Tailored Genetic (CTGC) protocol for~     African American women and evaluate its impact on decision making and satisfaction about~     BRCA1/2 testing, quality of life, and cancer control practices compared to Standard Genetic~     Counseling (SGC). A secondary objective of this study is to identify African American women~     who are most and least likely to benefit from CTGC vs. SGC.~   "
239556|NCT00419497|"~     The purpose of this study is to determine whether a paleolithic diet improves glucose~     tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose~     tolerance.~   "
239557|NCT00419484|"~     We want to investigate the effects of pioglitazone on cardiovascular events in Japanese~     patients with type 2 diabetes.~   "
239558|NCT00419471|"~     This study aimed to evaluate the efficacy and safety of escitalopram in the treatment of~     depressive patients with acute coronary artery syndrome (CAS).~   "
239559|NCT00419458|"~     The purpose of this study is to determine if inspiratory muscle strength training will~     increase the proportion of ventilator dependent patients weaned versus Sham treated patients.~   "
239563|NCT00419406|"~     Atopic dermatitis (AD) is a very common disorder that is characterized by pruritic~     inflammatory skin lesions, with patients usually having an individual or family history of~     atopic diseases in their background. Phototherapy is among the first-line approaches in the~     management of AD. In this context, a variety of studies have shown a beneficial effect of~     natural or artificial UV radiation in atopic dermatitis (AD). The past ten years have seen~     the introduction of new phototherapeutic regimens for AD, including UVA1 and NB-UVB.UVA1~     seems to be more effective than the above mentioned broadband spectra, in particular in acute~     severe AD. The aim of the present study is the comparison of UVA1 and NB-UVB phototherapy in~     the treatment of AD. Additionally, the course of several cytokines, human beta-defensins, and~     SMAD-proteins will be evaluated during the course of treatment.~   "
239564|NCT00419393|"~     To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term~     safety of Keppra XR in subjects with partial onset seizures.~   "
239565|NCT00419380|"~     The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear~     drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the~     new drug for any problems related to the medication. Patients are being asked to be in this~     study because they had tubes placed for the treatment of chronic ear infection and the~     tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes.~     This problem occasionally is improved with ear drops like Floxin®. However, it is frequently~     not improved even after this standard ear drop treatment.~   "
239566|NCT00419367|"~     In an effort to allow patients continued access to vorinostat outside of the base study,~     patients that are actively receiving study medication will discontinue from this study and~     receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program~     (NPP)). For those institutions that do not allow receipt of an investigational therapy~     outside of a clinical trial, patients that are actively receiving study medication and~      continue to meet eligibility will transition to an extension phase of the study and the base~     study will be closed.~      The extension phase will begin as soon as the protocol amendment is implemented.~   "
239567|NCT00419354|"~     1 To examine whether right ventricular pacing has an impact on tricuspid regurgitation~     grade that is related to pacing rather than to valve closure interference by the electrode.~   "
239568|NCT00419341|"~     The objective of this study is to assess the efficacy, tolerability, safety and~     pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).~   "
239569|NCT00419328|"~     The main objective of the trial is to explore the safety and biological activity of NGR-hTNF.~     The safety will be established by clinical and laboratory assessment. The biological activity~     will be evaluated by DCE-MRI with contrast media.~   "
239570|NCT00419315|"~     A randomized study of Alcohol Care Management for the treatment of alcohol dependence in~     primary care settings.~   "
239571|NCT00419302|"~     This trial was designed to compare meal related inhalation of Technosphere/Insulin to~     subcutaneous regular insulin in patients with type 2 diabetes.~   "
239572|NCT00419289|"~     Patients with Chronic Obstructive Pulmonary Disease (COPD) may benefit from an 8-week~     pulmonary rehabilitation programme. However, the effect of the programme tends to attenuate~     with time. Patients who complete the programme are randomized to continued rehabilitation~     follow-up and control follow-up.~   "
239573|NCT00419276|"~     To determine if following total knee replacement, putting local anesthetic—or numbing~     medication—for five days through a tiny tube next to the nerves that go to the knee will~     decrease the time that patients need to spend in the hospital.~   "
239574|NCT00419263|"~     This is a study for patients with flu who also have a fever as well as other flu symptoms.~     Patients must have had symptoms for less than 48 hours in order to participate. Patients will~     have two out of three chances of getting an active study treatment and the other third will~     receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the~     inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to~     be seen 5 more times after they are enrolled in the study.~   "
239575|NCT00419250|"~     The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum~     tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation~     schedule in subjects with relapsed or refractory B-cell CLL.~   "
239576|NCT00419237|"~     The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as~     measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic~     impairment and in healthy subjects following a single oral inhaled dose of GW685698X. From~     the study results it should be possible to assess if there is an altered Risk: Benefit in~     patients with moderate hepatic impairment~   "
239577|NCT00419224|"~     The purpose of this study is to determine whether influenza vaccination protects patients who~     receive a certain type of bone marrow transplantation.~   "
239578|NCT00419211|"~     To refine, implement and evaluate a motivationally-tailored exercise intervention for~     increasing physical activity and mental health during pregnancy and the postpartum.~   "
239579|NCT00419198|"~     We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct~     size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial~     infarction. It is currently unknown whether postconditioning actually decreases or simply~     delays myocardial cell death during reperfusion. In addition, the long term effects of~     postconditioning on recovery of myocardial contraction remains elusive. The objective of the~     present study is to determine whether infarct size reduction by angioplasty postconditioning~     is maintained at 6 months and whether functional recovery is improved at one year~     post-infarction.~   "
239580|NCT00419185|"~     To evaluate the anatomical and visual outcomes after vitrectomy and internal limiting~     membrane (ILM) peeling with indocyanine green (ICG) or trypan blue (TB) for idiopathic~     macular hole repair in a prospective randomized trial.~   "
239616|NCT00418717|"~     The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly~     dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg~     etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be~     more convenient for most patients. This once-weekly regimen is used in countries outside of~     Japan.~   "
239581|NCT00419172|"~     The study will consist of two open-label periods, a Treatment Period I (deferasirox) and a~     Treatment Period II (rifampicin+deferasirox). At least 18 subjects are expected to complete~     both treatment periods as per protocol. For all subjects, in addition to the two treatment~     periods, there will be a 21 day screening period, one baseline evaluation (the day preceding~     deferasirox administration in Treatment Period I), and an end-of-study evaluation (EOS).~     Study subjects will be required to remain in the unit from Day -1 until Day 17. EOS~     evaluation (final safety assessment) will be performed 7-10 days after the last dose of~     rifampicin.~   "
239582|NCT00419159|"~     To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day)~     everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite~     prior treatment with targeted therapy and chemotherapy.~   "
239583|NCT00419146|"~     The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA and/or~     Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related~     psychoses.~   "
239584|NCT00419133|"~     The purpose of this study is to compare the safety and immunogenicity of one and two doses of~     the killed oral cholera vaccine.~   "
239585|NCT00419120|"~     Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment~     will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous~     neo-bladder construct will significantly increase bladder compliance.~   "
239586|NCT00419107|"~     Diabetes is more frequent in women with Turner syndrome. The purpose of this study is to see,~     in what ways the glucose metabolism is different in this study population. The hypothesis is~     that women with Turner Syndrome have an impaired insulin production (beta cell function).~   "
239587|NCT00419094|"~     The primary objective of this study is to assess the efficacy of two doses of Keppra XR~     compared with a historical control as the placebo, in the monotherapy treatment of partial~     onset seizures.~   "
239588|NCT00419081|"~     The purpose of this study is to determine whether Forodesine Hydrochloride is effective in~     treating patients with relapsed/refractory precursor T-Lymphoblastic Leukemia/Lymphoma who~     have failed two or more prior treatment regimens.~   "
239589|NCT00419068|"~     The purpose of this study is to determine whether vitamin D enhances response to standard~     antibiotic treatment for pulmonary tuberculosis.~   "
239590|NCT00419055|"~     To determine the safety and feasibility of same day discharge after elective coronary~     percutaneous intervention in a selected stable patient population. The hypothesis to be~     tested is that in an appropriately selected stable coronary artery disease population post~     percutaneous coronary intervention, early discharge is safe and feasible.~   "
239591|NCT00419042|"~     The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural~     effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first~     line followed by Erlotinib when progression versus Erlotinib first line followed by~     Gemcitabine when progression~   "
239592|NCT00419029|"~     The goal of this randomized controlled trial is to evaluate the efficacy of~     telephone-administered motivational interviewing (TAMI) to enhance VA mental health treatment~     engagement among veterans of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF) who~     screen positive for mental health disorders on telephone assessment. The investigators will~     evaluate whether TAMI results in improved mental health treatment engagement, decreased~     mental health symptoms and increased quality of life among OEF/OIF veterans with mental~     health disorders. The long-term aim of this study is to conduct rapid assessment and~     intervention to prevent chronic mental illness and associated disability among our newest~     generation of veterans.~   "
239593|NCT00419016|"~     A family study of the negative association betweeen schizophrenia and cancer~   "
239594|NCT00419003|"~     This study is examining the safety and effectiveness of two medications, ketamine and~     riluzole, in treating patients with treatment resistant major depressive disorder. This study~     will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing~     the potential side effects associated with ketamine.~   "
239595|NCT00418990|"~     The purpose of this clinical trial is to determine if administration of a daily chewable~     multivitamin-mineral supplement (Monday - Friday when school is in session) given to children~     (third through sixth graders) during the academic school year will lead to improved academic~     performance.~   "
239596|NCT00418977|"~     This study will compare the effectiveness of two therapies to treat early signs of anorexia~     nervosa in adolescents.~   "
239597|NCT00418964|"~     The objective of this prospective study is to assess the clinical, functional and~     radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone~     graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain,~     swelling, mobility, quadriceps girth size, stability, proprioception, bone mineral density~     and functional status.~   "
239598|NCT00418951|"~     The goal of this clinical research study is to compare the effectiveness of liposomal~     amphotericin B given three times per week , versus liposomal amphotericin B given once per~     week, versus oral voriconazole in the prevention of fungal infections in patients with acute~     myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The~     safety of these treatments will also be studied and compared.~   "
239599|NCT00418938|"~     This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be~     conducted in the United States. Approximately 210 eligible KRAS wild-type expressing~     metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based~     chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses~     of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or~     progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive~     either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI~     regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and~     institutional standard of care).~   "
239617|NCT00418704|"~     The purpose of this study is to determine duration before progression of first-line treatment~     chemotherapy following erlotinib in second-line comparing erlotinib in first-line following~     chemotherapy in second-line in old patients with none small cell lung cancer.~   "
241455|NCT00394186|"~     This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve~     IBS pain or discomfort and associated symptoms in IBS patients.~   "
239600|NCT00418925|"~     Cervical dystonia (CD) is characterized by abnormal, involuntary sustained cervical muscles~     contractions associated with twisting movements and abnormal postures of the neck that can be~     quite disabling. Currently there are no good oral medications for the treatment of CD. While~     botulinum toxin injections are effective in most, they require repeat injections and there~     are some patients who either stop responding or who never respond at all. Therefore, better~     treatments are needed. While the underlying mechanisms of dystonia are not entirely known,~     there is some information suggesting that it is ude to an underactivity of a chemical~     compound, GABA, that is located in the basal ganglia. Cannabinoids are a compound than can~     enhance transmission of GABA, and thus, may alleviate the symptoms of dystonia. Dronabinol,~     one such cannabinoid, has been widely used to treat anorexia and nausea in chemotherapeutic~     patients. The aim of this study, therefore, is to study the effect of dronabinol on cervical~     dystonia~   "
239601|NCT00418912|"~     Schizophrenia is a severe mental illness which is considered to have, among other, a genetic~     etiology. One of the most efficient tools in genetic-psychiatry is the investigation of~     multiplex families.~      The current study will identify patients of multiplex families and to map their family~     connections and the presence of mental illnesses among family members.~   "
239602|NCT00418899|"~     The goal of this research study is to investigate the role of genes that may point to a~     higher risk of developing a glioma. Researchers will use new gene mapping techniques to study~     how high-risk factors are passed on through a family's genes and increase the risk of~     developing gliomas.~      Objectives:~      We propose an international multi-center, multidisciplinary study consortium, GLIOGENE, to~     identify susceptibility genes in high-risk familial brain tumor pedigrees using the most~     sophisticated genetic analysis methods available. To address our hypothesis, we propose the~     following specific aims:~      Aim 1: Establish a cohort of 400 high-risk pedigrees for genetic linkage analysis. To date,~     we have identified and collected biologic samples from 20 high-risk families that have met~     our criteria of 2 or more relatives diagnosed with a brain tumor. From the 15 centers in the~     United States and Europe, we will screen and obtain epidemiologic data from approximately~     17,080 gliomas cases to identify a target of 400 families for genetic analysis. We will~     establish a cohort of the first and second-degree relatives from these glioma cases to obtain~     new knowledge about how cancer aggregates in glioma families. We will also acquire~     biospecimens (blood and tumor tissue), and risk factor data from relevant family members.~      Aim 2: Identify candidate regions linked to familial brain tumors. To strengthen evidence of~     linkage to regions found in our preliminary analysis and to identify additional regions~     linked to brain tumors, we will genotype informative glioma pedigrees identified in aim 1~     using Affymetrix 10K GeneChip with markers spaced throughout the genome, and conduct a~     genome-wide multipoint linkage scan with these markers.~      Aim 3: Fine map the regions established in Aim 2 by genotyping selected SNPs from genome~     databases. We will attempt to further refine the regions identified in Aim 2 to less than 1cM~     by using approximately 1,500 - 2,000 carefully selected SNPs. The prioritization of regions~     will be based on a combination of the strength of evidence for linkage from families of~     various ethnic backgrounds and the presence of obvious candidate genes.~   "
239603|NCT00418886|"~     Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop~     them from dividing, or stop the growth of the blood supply that cancers need to grow and~     spread. Clinical research has shown that drugs that inhibit vascular endothelial growth~     factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase~     overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical~     studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR~     signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking~     their blood supply and by stopping them from dividing. This lung cancer study is to~     investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta~     (pemetrexed) alone.~   "
239604|NCT00418873|"~     The purpose of this study is to compare the efficacy and tolerability of zotepine versus~     Risperidone in aggressive schizophrenic patients.~   "
239605|NCT00418860|"~     The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and~     clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in~     terms of death, myocardial infarction, or stent thrombosis.~   "
239606|NCT00418847|"~     The purpose of the study is to investigate the pharmacokinetics of Zavesca (miglustat,~     OGT918) when given as single and multiple doses in juvenile patients with GM2 gangliosidosis.~   "
239607|NCT00418834|"~     A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at~     high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given~     in combination and two higher doses of atorvastatin on lipid lowering.~   "
239608|NCT00418821|"~     The purpose of this study is to determine if laronidase is present in the breast milk of~     post-partum women receiving Aldurazyme® (laronidase) and the effects of Aldurazyme~     (laronidase) on the growth, development, and immunologic response of their breastfed infants.~   "
239609|NCT00418808|"~     Cerebral Palsy (CP) is a major developmental problem. Major risk groups of CP, are preterm~     infants and multiple pregnancies. Previous studies using the General Movements methodology~     demonstrated early identification of CP, as early as 3 month of age. This method was~     implemented mainly on preterm infants this study goal is to enlarge the scope of the~     methodology to infants of multiple pregnancies. A second goal is to study early motor~     development and its future consequences by comparing the development of the infants of the~     same multiple pregnancy.~   "
239610|NCT00418795|"~     A multi-centre, double-blind, randomized, placebo controlled, parallel group trial,~     investigating the efficacy and safety of Porphozym (recombinant human porphobilinogen~     deaminase)in the treatment of acute attacks in AIP.~   "
239611|NCT00418782|"~     CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for~     the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is~     to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus~     placebo and naproxen treatment in patients with OA knee pain.~   "
239612|NCT00418769|"~     Bioavailability study comparing two new nilotinib tablet formulations to an established~     nilotinib capsule formulation in healthy volunteers~   "
239613|NCT00418756|"~     This study will evaluate the effect of 600 mg daily oral dose of rifampin (CYP3A4 inducer) on~     the pharmacokinetics of a single 400 mg oral dose of nilotinib in healthy subjects~   "
239614|NCT00418743|"~     The purpose of this study is to determine treatment efficacy and tolerability of second-line~     treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy~     with intravenous combination chemotherapy.~   "
239615|NCT00418730|"~     The purpose of this study is to measure the hair growth response to topical NEOSH101 when~     applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with~     Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will~     participate. Three equally sized treatment groups (60 men each) will receive either topical~     NEOSH101 2.0%, minoxidil 5%, or placebo.~   "
239619|NCT00418678|"~     This is a Phase IV, open-label, sequential treatment study in patients who are receiving~     standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer.~     (See Section 4.2.1 for eligible treatment regimens.) The study will take place during the~     first 2 cycles of chemotherapy.~      Phase 1 of study:~      Prior to the first dose of chemotherapy, patients will be instructed on how to complete their~     patient diary, which will include a Visual Analogue Scale (VAS) for nausea and a VAS for~     pain. In addition, the diary will include a section to list their current pain medications~     (see Sample Patient Diary in Appendix I). After being instructed, patients will complete the~     VAS for nausea and for pain, as well as listing their current pain medications. Patients will~     then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard~     serotonin antagonist/corticosteroid regimen.~      Beginning on Day 2, the diary will be completed for 5 consecutive days (Days 2-6). Each day,~     patients will complete a diary entry pertaining to the preceding 24 hours. The entry will~     include the number and time of any emetic episodes, any antiemetic rescue medications used,~     VAS for nausea, and side effects of treatment. On the last day of the diary (Day 6), the~     entry will include the above daily parameters but will also include a VAS for pain. In~     addition, the patient will complete a diary entry pertaining to the 5-day study period that~     will include pain medications used. Patients will also complete the Functional Living Index -~     Cancer (FLIC) questionnaire (see Sample Function Living Index - Cancer questionnaire in~     Appendix II).~      Patients who either have at least one vomiting episode or at least one report of significant~     nausea (VAS > 25 mm) during the first 5-day study period will be eligible for the second~     phase of the study.~      Phase 2 of the study:~      Patients in the second phase will receive a second cycle of the same chemotherapy. The~     antiemetic regimen for the second cycle will be the same serotonin antagonist/corticosteroid~     regimen as they received in Cycle 1, with the addition of Cesamet.~      For Cycle 2 of treatment, patients will receive Cesamet 1 mg the night before chemotherapy is~     to be administered. On the day of chemotherapy (Day 1 of Cycle 2), Cesamet 2 mg will be given~     1 to 3 hours before the chemotherapy is administered, in addition to the same serotonin~     antagonist/corticosteroid regimen as they received in Cycle 1. Patients will receive an~     additional dose of Cesamet 2 mg the evening of Day 1.~      Patients will receive Cesamet 2 mg BID on Days 2-5. Patients will complete the same 5-day~     diary and FLIC questionnaire as they did in Cycle 1. Beneficial effects of Cesamet will be~     estimated by comparing the results of the second cycle to the results of the first cycle.~      Patients will be evaluated for the first 2 cycles of chemotherapy only.~   "
239620|NCT00418665|"~     This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG~     531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects~     with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are~     planned to receive at least four cycles of lenalidomide for treatment of their disease are~     appropriate to screen for this study.~      All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by~     mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a~     week by subcutaneous injection for 16 weeks.~   "
239621|NCT00418652|"~     Trans Cranial Magnetic Stimulation (TMS) over dorsal visual system will disturb the ability~     to identify objects with decreased level of fragmentation~   "
239622|NCT00418639|"~     This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on~     end of treatment virologic response, sustained virologic response, reduction of quantitative~     serum HCV RNA, changes in ALT and safety parameters.~   "
239623|NCT00418626|"~     This study will be a formal assessment of the impact of hepatic function impairment on the~     pharmacokinetics of nilotinib~   "
239624|NCT00418613|"~     A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic~     Obstructive Pulmonary Disease (COPD).~   "
239625|NCT00418600|"~     Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis~     patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary~     hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis~     patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection)~     is indicated for the treatment of secondary hyperparathyroidism in patients with chronic~     kidney disease on dialysis.~      This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol~     capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will~     enroll hemodialysis patients that have been controlled on intravenous Hectorol. the~     information gained from this study will be a useful guide for physicians in managing CKD~     Stage 5 patients for whom a change from intravenous to oral vitamin D administration is~     appropriate.~   "
239626|NCT00418587|"~     The purpose of this study is to test the safety and effectiveness of different doses of~     vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to~     determine if vitamin D could be used as a treatment and/or preventative of SLE.~   "
239627|NCT00418574|"~     The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an~     experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms~     of time the remission status is kept as well as prolongation of life expectancy.~   "
239628|NCT00418561|"~     Objectives: The overall objective is to evaluate the safety, efficacy and pharmacokinetics~     (PK) of rhASA treatment in patients with late infantile MLD.~      Methodology: This is a single center, open-label study of patients with late infantile MLD.~     Twelve patients will be enrolled in this study receiving a total of thirteen intravenous~     infusions of Metazym. One infusion will be given every other week for a period of half a~     year. After the half year the subjects will continue treatment every other week until safety~     data is available. Safety (AE/SAE) will be monitored at every visit during this period.~   "
239629|NCT00418548|"~     The purpose of this study is to compare efficacy, pharmacokinetics, and safety of~     investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice~     weekly and placebo in patients with ankylosing spondylitis (AS).~   "
239630|NCT00418535|"~     Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma~     (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain~     disease-free. The efficacy of the conventional anthracycline-based chemotherapy~     (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory.~      The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal~     dose, sequence, and multi-modality treatment with involved field radiotherapy still need to~     be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with~     cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized~     NK/T-cell lymphoma patients.~   "
239631|NCT00418522|"~     This study is to determine if inhaled insulin is effective in treating type 2 diabetes~     mellitus.~   "
239632|NCT00418509|"~     This study will compare the performance of three combination metered dose inhalation devices~     and the variability of mometasone and formoterol doses delivered to the lungs in a healthy~     volunteer population~   "
239633|NCT00418496|"~     The primary objective of this study will be to determine the toxicity and Maximum Tolerated~     Dose (MTD) of the combination of high dose aldesleukin and sorafenib in previously untreated~     patients with metastatic or unresectable clear cell renal carcinoma (RCC) and metastatic~     melanoma.~   "
239634|NCT00418483|"~     The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus~     Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin~     doses to dissolve the clots will be estimated by arteriography.~   "
239635|NCT00418470|"~     Patients with cystic fibrosis (CF) need to frequently undergo courses of IV antibiotic~     therapy. To avoid a high number of venipunctures peripheral venous catheters (SPVC) or~     cannulas are used. Because of the irritant action of the drugs used, SPVC's often do not last~     for the whole antibiotic course (usually of two weeks) and the patient has to be punctured~     again for the insertion of a new IV line. With the passing of time the veins are more~     difficult to be found. An alternative to the use of a cannulas is the surgical insertion of a~     central venous catheter. This intervention may have contraindications or, specially in~     adolescents, cause unacceptable alterations of the body image.~      The aim of this study is to find a way to prolong the duration of the SPVC used by CF~     patients during antibiotic courses avoiding the irritation of the vein or a phlebitis.~      Design of the study: randomized controlled trial. The study will see a collaboration of~     nurses, physicians and technicians of the Tuscan CF Centre.~      The patients that will participate at the study will be randomly assigned to one of the two~     groups: one group will receive the antibiotics prescribed according to the maximal dilution~     suggested by the pharmaceutical company, the other will receive a much higher dilution (i.e.~     a higher volume of Normal Saline), but the time of administration will be the same.~      The assessment will regard: the level of inflammation of the vein (with a special visual~     scale) and the duration of the SPVC.~      The hypothesis that is to be proved is that diluting the antibiotic in a higher volume of~     Normal Saline it is possible to delay or prevent the irritation of the vein and the onset of~     a phlebitis.~      In case that the hypothesis will be confirmed by this study an easy, secure, low cost and~     immediately available system will be available to reduce the number of venipunctures~     necessary to complete a course of IV antibiotics.~   "
239636|NCT00418457|"~     In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy~     with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral~     anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be~     followed for up to 10 years to determine the rate of cancer recurrence or metastasis.~   "
239637|NCT00418444|"~     The purpose of this study is to test an innovative intervention geared towards issues of~     identity, body image and sexuality, and to examine the intervention for its impact on body~     image, quality of life, psychosocial/sexuality/relational functioning.~   "
239638|NCT00418431|"~     Central serous chorioretinopathy (CSC) has been known since it was first described by Von~     Graefe and termed “idiopathic detachment of the macula” in 1866, is a well-characterized~     disorder leading to serous neurosensory elevation of the central macula. The acute form of~     the disease is associated with focal leakage at the level of the retinal pigment epithelium~     (RPE) demonstrated with fluorescein angiography (FA). The disorder is self-limited in the~     majority of patients, who also regain excellent vision. Occasionally, the neurosensory~     detachment persists and leads to pigment epithelial and photoreceptor damage with visual~     impairment.~      The purpose of this clinical study is report the use of intravitreal bevacizumab is a new~     option in the treatment of the chronic or recurrent CSC.~   "
239639|NCT00418418|"~     This is a prospective double blind trial of intraoperative transmyocardial bone~     marrow−derived mesenchymal cell transplantation vs placebo in patients with low left~     ventricular ejection fraction scheduled to coronary bypass operation.~   "
239640|NCT00418405|"~     Rheumatoid arthritis is a relatively common autoimmune disease that affects about 1% of the~     population. Its impact on health-related quality of life of the affected patients and the~     national medical cost are enormous. However, a systemic prospective cohort study of~     rheumatoid arthritis has not yet been established in Korea, so data on characteristics and~     prognosis of Korean rheumatoid arthritis and their response to therapy and adverse events are~     limited. Therefore establishment of large prospective cohort of Korean rheumatoid arthritis~     is imperative.~      With inauguration of a steadfast prospective cohort of Korean rheumatoid arthritis patients~     in The Hospital for Rheumatic Diseases at Hanyang University, where patients gather from all~     over Korea forming the largest and most diverse patient pool in Korea, we will be able to~     define the characteristics and prognosis of Korean rheumatoid arthritis patients and gather~     information on treatment response and adverse events. This will eventually lead to~     improvement of health-related quality of life in Korean rheumatoid arthritis patients and~     provide opportunity for reliable comparison study with research institutes from other~     countries. The data gathered through the cohort will provide valuable foundational~     information for the genetic studies, pharmacological economic analyses, and standard~     treatment guidelines of Korean rheumatoid arthritis patients.~   "
239641|NCT00418392|"~     The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first~     episode, and the optimal treatment remains unknown. In the recently published British~     Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment~     for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of~     this procedure was as high as 25-30%, making it inappropriate as a standard of care.~      Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way~     to shorten the duration of air leaks and reduce the rates of recurrent spontaneous~     pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline,~     talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous~     pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer~     available. Talc insufflation of the pleural cavity is safe and effective for primary~     spontaneous pneumothorax. However, it should be applied either with surgical or medical~     thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in~     inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional~     minocycline pleurodesis is a safe and convenient procedure to decrease the rates of~     ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In~     the present study, additional minocycline pleurodesis will be randomly administered in~     patients with first episode of primary spontaneous pneumothorax after simple aspiration to~     test if it can reduce the rate of recurrence.~   "
239642|NCT00418379|"~     A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR~     sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen~     rhinoconjunctivitis~   "
239643|NCT00418366|"~     A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes~     medication~   "
239644|NCT00418353|"~     Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality~     by specifically reducing the risk of respiratory distress syndrome, intraventricular~     hemorrhage and neonatal death among premature infants. No human randomized study has formally~     compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal~     therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality.~     Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in~     reducing perinatal morbidities and mortality among preterm infants.~   "
241456|NCT00394173|"~     The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for~     relieving symptoms of IBS-D in female patients.~   "
239645|NCT00418340|"~     Irritable bowel syndrome (IBS) is a common condition. At least 20% of the population suffer~     from IBS. The symptoms of abdominal pain, diarrhoea, constipation, bloating and difficulty~     with bowel motions are often disabling. Many of those affected are young and report a poor~     quality of life (QOL) to a degree that is similar to gut inflammatory conditions like~     ulcerative colitis and Crohn's disease. Yet the impact of IBS on patients' lives is often~     underestimated. This is probably because unlike inflammatory bowel disease, in which the~     bowel is inflammed and bleeds, the bowel in IBS looks normal. Instead the problem is of~     abnormal functioning of the gut the cause of which is unknown.~      Currently therapy for IBS is limited and until recently therapy has focused on treating the~     symptoms to improve QOL primarily because the underlying mechanism of IBS is poorly~     understood. However as more processes are being implicated in IBS e.g. visceral~     hypersensitivity (excessive response to sensory stimuli within the gut), infection, immune~     activation, dysmotility and abnormal gut fermentation , the potential for new therapies looks~     promising. The evidence that gut bacteria play a role in inducing IBS symptoms is due to~     observations of an improvement of IBS symptoms with probiotic therapy (bacterial supplements)~     and antibiotic therapy.~      Patients with IBS are hypersensitive to colorectal distension compared with healthy controls.~     Studies carried out in our unit have shown that visceral pain thresholds in response to~     stress are lower in patients with IBS compared with healthy volunteers. This hypersensitivity~     is apparent in response to both a physical and chemical stimulus but the triggers to visceral~     hypersensitivity remain largely unknown. Animal models suggest roles for both host immune~     response and intestinal bacteria in the induction of visceral hypersensitivity. This proposal~     will focus on further exploration of the mechanisms underlying visceral hypersensitivity to~     direct future targeting of therapy.~      Previous independent studies showed that (a) bacteria reduce visceral hypersensitivity,~     (b)probiotic therapy can alter gut immune response and (c) gut sensation is affected by the~     type of immune cells in the gut. Our research proposal will investigate the relationship~     between gut bacteria, the immune system and the sensory gut nerves in order to understand how~     IBS symptoms are generated. This understanding will be the critical for effective future drug~     treatment.~   "
239646|NCT00418327|"~     The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD)~     of Tarceva in children as single agent and in combination with radiation therapy~   "
239647|NCT00418314|"~     The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and~     inter-ventricular (V-V) delay optimization using QuickOpt in patients with cardiac~     resynchronization therapy device results in improved clinical response over standard of care~     (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram~     optimization methods).~   "
239648|NCT00418301|"~     The primary objective of this study is to identify the brain regions in which activity is~     affected by SCS. Baseline cerebral blood flow scans with the device turned off will be~     generated compared to scans produced with the device operating at parameters which produce~     optimal coverage of the painful areas. The relationship between cerebral blood flow and pain~     rating scores will be evaluated in both conditions.~   "
239649|NCT00418288|"~     Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence~     world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing~     effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New~     animal studies indicate a protective effect of GLP-1 in the brain and the heart. The~     mechanism behind this is yet not known.~      The study hypothesis is that during hypoglycaemia GLP-1 will stimulate glucose-uptake in the~     brain and heart independent of insulin and thereby exert protective effects in the brain.~   "
239650|NCT00418275|"~     To evaluate the safety profiles of HTU-PA in patients with acute ischemic stroke.~   "
239651|NCT00418262|"~     Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.~   "
239652|NCT00418249|"~     The primary objective of this study is to assess the safety and efficacy of topical AS101 as~     treatment for Female Androgenetic Alopecia (FAGA) in menopause women.~   "
239653|NCT00418236|"~     It has been shown that women who have dense breasts have an increased risk of breast cancer~     compared with women whose breasts are less dense. However, while breast density may be a risk~     factor, the etiology of the relationship between breast cancer and breast density is not~     understood. Furthermore, it is well recognized that breast cancer can still develop in women~     whose breasts are not dense.~      At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a~     lack of hormonal stimulation. This is characterized as a decrease in the mammographic~     density. Although certain medications, including hormone therapy (HT) and dopamine~     antagonists can increase breast density, these effects are reversible upon discontinuation of~     the specific agent. Other medications such as the selective estrogen receptor modulators~     (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and~     allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM,~     on breast density are not known. The purpose of this study is to examine the effect of BZA on~     breast density changes over 24 months in postmenopausal women. The results may be useful for~     clinicians to understand the effect of BZA on breast density and its mammographic effects.~      This is an observational, multicenter, double-blind, randomized, placebo- and active~     comparator-controlled study. It is also an ancillary that will use women who are already~     participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary~     study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo.~     This ancillary study will request a subset of participants to use their mammograms taken in~     this study. Their mammogram will be digitized by a central imaging center. A single~     radiologist will perform the quantifications of breast density from the digitized mammograms.~   "
239654|NCT00418223|"~     The purpose of this study is a systematical registration of ultrasound measurements and~     urinary volume after catheterization. Based on these pairs of measurements we will calculate~     the reliability of ultrasound compared with catheter volume.~   "
239655|NCT00418210|"~     Hypothesis:~      In selected women with node-negative invasive breast cancer treated with breast conserving~     surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of~     the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically~     feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local~     control rate in a multicentre trial.~   "
239656|NCT00418197|"~     The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated~     for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the~     diseased facets following surgical removal. TFAS® offers the surgeon new options for treating~     spinal stenosis patients, enabling a more comprehensive decompression via complete removal of~     the facets. TFAS® also offers an alternative to rigid spinal fusion fixation enabling~     intervertebral motion. The clinical trial is intended to demonstrate restoration of stability~     and sagittal balance to the spine. TFAS® also eliminates the need for painful bone graft~     harvest from the patient's hip which may be required with fusion procedures.~   "
239657|NCT00418184|"~     The primary objective of this trial is to determine whether an oral administration of~     Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children~     suffering from ADHD. Both the behavior and the academic achievements aspects will be~     evaluated. In addition, we intend to measure side-effects and adverse events and to examine~     the possible correlation between biochemical and behavioral alterations.~   "
239658|NCT00418171|"~     The primary objective of the study is to estimate the relative incidence among users of~     ziprasidone and olanzapine of non-suicide mortality.~   "
241457|NCT00394160|"~     The purpose of this study is to look at the preliminary safety profile of an investigational~     drug in children 1 to < 3 months of age with bronchiolitis.~   "
239659|NCT00418158|"~     Abstract: Post-operative pulmonary complications after cardiac surgery~      Background The Catharina Hospital performs approximately 1700 heart operation each year. One~     third of the patients stay at the Catharina hospital during their entire post-operative~     period. Two years ago they abolished the pulmonary support by a physiotherapist.~     Subjectively, the pulmonary complications increased over the last two years. During an~     investigation of the contentment of the patients an increase of the pulmonary problems came~     forward after eliminating the pulmonary support. There have been no further examinations to~     the pulmonary complications post-operatively.~      Objectives The aim of this study is to give the department of cardio-thoracic surgery an~     advice about the post-operative pulmonary support for patients who underwent heart surgery.~      During the study a budgetary analysis will be made.~      Methods 120 patients are prospectively randomised in three groups. Randomisation takes place~     through block randomisation every three weeks. 40 patients will be supported by a~     physiotherapist. Another 40 patients will be supported by the nurses on the cardiothoracic~     surgery ward and the last 40 patients will use an incentive therapy with 'Airlife' by a~     self-management method.~      The study population are all patients undergoing heart surgery and spend their entire~     post-operative period at the Catharina Hospital. In- and exclusion criteria are specified in~     the protocol on pages 3 and 4.~      Outcome The primary outcome is to qualify the pulmonary complications within the three~     groups. These complications will be objectified by measuring peak flow, an instrument to~     determine the lung function, and an x-ray of the thorax.~      The secondary outcome is the contentment of the patient, which will be determined by a~     VAS-score (Visual Analogue Scale).~      Risks There are no risks for the patient when participating on this study. The patient will~     have to fill in the VAS-score and measure lung function with the peak flow at two different~     moments. The study takes place in a clinical setting. There is no extra insurance in~     conformity with the advice of the METC.~   "
239660|NCT00418145|"~     This clinical trial compares the relative efficacy of treating acute exacerbations of~     relapsing forms of Multiple Sclerosis with equivalent doses of oral and intravenous (IV)~     methylprednisolone. This is a randomized, blinded, multi-center study.~   "
239661|NCT00418132|"~     Progressive systemic sclerosis (SSc) is an immune-based disease that causes abnormal~     connective tissue growth of the skin and internal organs. At this point, there are no~     effective therapies for treating SSc. Thalidomide is a medication that has been shown to~     stimulate an immune response that reduces the body's synthesis of collagen, the main~     component of connective tissue. This study will determine the effectiveness of thalidomide in~     treating adults with SSc.~   "
239662|NCT00418119|"~     Erythropoietin Treatment in Patients with systolic left ventricular dysfunction, mild anemia~     and normal renal function~   "
239663|NCT00418106|"~     Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have~     investigated the maternal and infant benefits associated with kangaroo holding. The purpose~     of this study is to determine if kangaroo holding a baby changes the amount and composition~     of breast milk pumped before and after the kangaroo holding session.~      Hypotheses:~        1. There is a significant difference in volume of maternal breast milk pumped after~          kangaroo holding premature infants as compared to maternal breast milk pumped after~          non-holding conditions~        2. There is a significant difference in the composition of maternal breast milk pumped~          after kangaroo holding premature infants as compared to maternal breast milk pumped~          after non-holding condition.~   "
239664|NCT00418093|"~     The main purpose of this study is to begin to collect information and try to learn whether or~     not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with~     recurrent mullerian carcinoma. We will also collect more information about the safety and~     side effects of this combination of drugs. Gemcitabine and oxaliplatin are chemotherapy drugs~     that kill cancer cells. Bevacizumab is a new anti-cancer drug that works to slow or stop cell~     growth in cancerous tumors by decreasing the blood supply to the tumors.~   "
239665|NCT00418080|"~     As clinical primary endpoints we assessed whether existed differences in:~        1. PSA recurrence rate stratified according to treatment modalities~        2. EGFR and HER2/neu overexpression rate stratified according to treatment modalities~        3. PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.~      As secondary clinical endpoints we assessed whether existed differences in:~        1. prostate cancer-specific mortality according to treatment modalities~        2. prostate cancer-specific mortality stratified according to EGFR and HER2/neu~          overexpression levels.~      For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA~     recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality~     Pre-clinical endpoints As pre-clinical endpoint we assessed whether exist differences in~     efficacy rate of Bicalutamide and Gefitinib treatment in primary tumor cultures stratified~     for high and low EGFR and HER2/Neu expression levels. The evaluation of efficacy rate of~     these treatments was documented by comparing the differences of drugs IC50 values among the~     groups stratified for EGFR and HER2/Neu levels.~   "
239666|NCT00418067|"~     The purpose of this study is to establish the safety and long-term effectiveness of coronary~     stenting with the ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs.~     the sirolimus-eluting balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey)~     and the paclitaxel-eluting stent (Taxus liberte, Boston Scientific) for the treatment of~     coronary stenosis in routine clinical practice.~   "
239667|NCT00418054|"~     The purpose of this study is to evaluate the safety and efficacy of~     nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy~     in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide~     monotherapy in the treatment of chronic hepatitis C.~   "
239668|NCT00418041|"~     Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study) is a~     large, prospective, hospital-based cohort study to investigate the following:~        -  Characteristics of patients with chronic heart failure and prognostic risks of these~          patients.~        -  Characteristics of patients with high risk for heart failure and critical factors which~          predict the development of symptomatic heart failure in these patients.~        -  The incidence and prognostic impact of metabolic syndrome in patients with chronic heart~          failure.~        -  The association between metabolic syndrome and the development of symptomatic heart~          failure.~   "
239669|NCT00418028|"~     Capecitabine is active in metastatic breast cancer but the conventional schedule (1250~     mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in~     up to 50% of patients leading to those reductions. There are theoretical reasons to~     administer S-phase specific agents in continuous, protracted rather than intermittent~     schedules. The investigators study compares the standard schedule (1250 mg/m2/12 hr 2 weeks~     on, one week off) with a continuous administration schedule (800 mg/m2/12hr). The latter~     administer approximately the same cumulative dose of capecitabine as the standard schedule.~     The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from~     50% (standard arm) to 20% (experimental arm). The investigators assume similar antitumor~     activity in both arms.~   "
241458|NCT00394147|"~     The purpose of this study is to look at how well the combination of two chemotherapy drugs,~     pemetrexed (Alimta) and gemcitabine (Gemzar) work to treat your cancer.~   "
239670|NCT00418015|"~     Pharmacogenetics has allowed clinicians to identify associations between an individual's~     genetic profile and his/her response to drugs. The A118G (c.188A>G)is a single nucleotide~     polymorphism (SNP) of the mu-opioid receptor (OPRM1). The mutated protein, N40D, appears to~     increase the binding affinity and potency of beta-endorphin approximately 3-fold. Individuals~     carrying the variant receptor gene (A118G) may show differences in some of the functions~     mediated by beta-endorphin action at the altered OPRM1. Combined spinal-epidural (CSE)~     analgesia is a commonly utilized technique for labor analgesia. Analgesia is initiated with~     the intrathecal administration of a lipid-soluble opioid (e.g. fentanyl), sometimes combined~     with a local anesthetic. The mean (± SD) duration of analgesia after intrathecal fentanyl 25~     microgram was 89 ± 43 min. The ED50 of intrathecal fentanyl for labor analgesia varies~     between 14 microgram to 18.2 microgram. The wide variability in the duration of analgesia, as~     was well the differences in ED50 may result from differences known to affect labor pain~     (e.g., ethnicity, parity, stage of labor). Another possible explanation for the differences~     in opioid requirements and duration, as well as incidence of side effects such as itching and~     nausea/vomiting, is that opioid responsiveness is determined by genetic variability of the~     µ-opioid receptor. The ED50 for intrathecal fentanyl labor analgesia was significantly lower~     for parturients carrying the A118G variant of the mu-opioid receptor, compared to parturients~     with the A118 wild type receptor. The purpose of this study is to determine whether~     polymorphism at nucleotide 118 of OPRM1 influences the duration of intrathecal opioid~     (fentanyl) labor analgesia, and intrathecal opioid (morphine) postoperative analgesia.~   "
239671|NCT00418002|"~     The purpose of this study is to assess safety and tolerability of AQW051 administered in~     single and multiple doses to elderly healthy volunteers. In addition, pharmacokinetic effects~     will be assessed and the possible effects on cognition.~   "
239672|NCT00417989|"~     Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for~     subjects in the 722 Group is greater than that for subjects in the Control (MDI) Group.~      Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic~     variability, Area Under the Curve (AUC); Quality of Life; and Health Economic Outcomes (MRU)~   "
239673|NCT00417976|"~     This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine~     then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients'~     response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response~     Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor~     marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure~     response.~   "
239674|NCT00417963|"~     To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire~     Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery~     stenosis in patients at high risk for carotid endarterectomy.~   "
239675|NCT00417950|"~     To understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will~     further lower post meal glucose and inflammatory state when taking together with moderate~     amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or~     mild diabetes.~   "
239676|NCT00417937|"~     To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus~     twice daily in the treatment of patients with papulopustular rosacea.~   "
239677|NCT00417924|"~     Vision loss from diabetes is often preventable with timely detection and treatment. Patients~     with diabetes may not understand the importance of annual dilated eye examinations or~     recognize the benefits of early detection of diabetic eye disease. The proposed research~     project compares usual eye care to eye care emphasizing patient education for adult patients~     with diabetes.~   "
239678|NCT00417911|"~     Multiple myeloma is a malignant incurable hematological disease where survival has been~     significantly improved by high-dose melphalan with autologous stem cell support (ASCT) in~     younger patients. However, the disease will eventually relapse and new treatment is demanded.~     Bortezomib is a newly approved drug for treating relapsing multiple myeloma. It has a~     different biological effect and response even in patients refractory to conventional~     chemotherapy. The purpose of the study is in a randomized design to investigate if addition~     of bortezomib by 20 injections during a 4 months period starting 3 month after ASCT can~     prolong the time to progression compared to patients receiving no consolidation or~     maintenance therapy.~   "
239679|NCT00417898|"~     This study will determine the safety of 500mg of aspirin added to IV TPA at standard doses to~     prevent re-occlusion of cerebral vessels after successful reperfusion. In ischemic stroke~     brain arteries are occluded either by an embolus originating in the heart or large vessels~     leading to the brain or by a process of acute thrombosis of the cerebral arteries over a~     ruptured atherosclerotic plaque. Rupture of the plaque exposes thrombogenic elements within~     the plaque and leads to accumulation and activation of platelets and induction of the~     clotting cascade eventually leading to acute thrombosis and occlusion of the artery. TPA is~     currently approved by the Food and Drug Administration to treat heart and brain problems~     caused by blockage of arteries. It activates plasminogen and leads to disintegration of the~     thrombus/embolus. It is effective only if begun within 3 to 4.5 hours of onset of the stroke~     because of potential deleterious side effects including life threatening symptomatic~     intracranial hemorrhage (sICH) when the drug is administered outside of this time window.~      Reperfusion of the ischemic brain (i.e. timely opening of the occluded artery) with TPA is~     associated with improved outcome. However, in about 33% of patients that have successfully~     reperfused after TPA the artery re-occludes within the first few hours resulting in worsening~     neurological symptoms and worse functional outcome. This re-occlusion is speculated to result~     from re-thrombosis over an existing ruptured atherosclerotic plaque. This is explained by the~     relatively short half life of TPA leaving the exposed ruptured plaque intact which leads to~     re-activation of platelets and clotting factors and re-thrombosis. Thus, we hypothesize that~     the addition of an antiplatelet agent to TPA would result in lower rates of re-occlusion~     after AIS. The FDA approved TPA for patients with AIS but discouraged the concomitant use of~     anti-platelet or anti-thrombotic drugs for the first 24hours after administration of TPA~     because of concerns that such therapy may result in increased rates of intracerebral~     hemorrhage. Aspirin is a well known platelet anti-aggregant that works by inhibition of~     cycloxygenase 1 and reduction in thromboxane A levels. It has a rapid onset of action and~     additional potential beneficial anti-inflammatory effects in patients with AIS. The~     international stroke study showed that acute treatment of stroke patients with 500mg of~     aspirin is safe and feasible and results in better outcome. Furthermore, the drug was safe in~     these circumstances with an ICH rate of only .~      Therefore, the purpose of this clinical trial is to examine the safety and efficacy of the~     combination of aspirin with rt-TPA in patients with AIS.~   "
239680|NCT00417885|"~     To assess progression-free survival at the combination dose determined in the Phase 1 portion~     of the study, and safety of sunitinib combined with exemestane in patients with metastatic or~     locally-recurrent, unresectable breast cancer.~   "
239749|NCT00416988|"~     RATIONALE: An educational program may be effective in increasing monthly skin~     self-examinations to detect melanoma in healthy participants.~      PURPOSE: This randomized clinical trial is studying how well an educational program works in~     increasing monthly skin self-examinations to detect melanoma in healthy participants.~   "
239681|NCT00417872|"~     The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg~     b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of~     Clotridium difficile colitis after seven days of treatment. Secondary objectives are to~     provide information on the times from first dose to last unformed stool and resolution of~     symptoms of colitis, the sustained response rates for the different tratment groups and the~     effect of treatment on Clostridium difficile toxin enzyme immunoassay/culture results during~     hospitalization.~   "
239682|NCT00417859|"~     The goal of this study is to provide gait parameters as a new objective method to assess~     total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an~     ambulatory device with minimal sensor configuration.~   "
239683|NCT00417846|"~     The purpose of this study is to determine the sensitivity of the optical coherence tomography~     (OCT) test in detecting neovascular AMD in eyes at high risk for CNV development. In order to~     test this hypothesis, we are conducting a multi-center clinical study at four participating~     clinical centers. A total of 227 participants will be enrolled. Participants will be~     followed-up for a period of two years, or until CNV develops in the study eye for which~     treatment is recommended, to determine the occurrence of CNV. The fundamental design~     principles of the study are simplicity and parsimony.~   "
239684|NCT00417833|"~     Purpose: Determine the short-term safety of intravitreal bevacizumab by multifocal~     electroretinography (mf-ERG).~      Methods: 120 eyes with choroidal neovascularization, proliferative diabetic retinopathy and~     retinal vein occlusion received intravitreal bevacizumab (2.5mg/0.1cc). All patients~     underwent best corrected visual acuity, fluorescein angiography, optical coherent tomography~     and mf-ERG before and 1 month after treatment.~   "
239685|NCT00417820|"~     The purpose of this study is to assess the local tolerability of a single topical~     administration of BCT194 in healthy volunteers and, potentially, to evaluate the safety,~     tolerability, and efficacy of a multiple topical administrations in patients with psoriasis.~   "
239686|NCT00417807|"~     An open-label, non-comparative study conducted to investigate the activity and safety of~     imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R.~     Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated~     according to Recist criteria~   "
239687|NCT00417794|"~     The purpose of this study is to determine if atomoxetine hydrochloride improves inattention,~     hyperactivity, and impulsivity problems in children exposed to alcohol during birth.~   "
239688|NCT00417781|"~     Background: Attention deficit hyperactivity disorder (ADHD), characterized by inattention,~     hyperactivity and impulsivity, is an early onset, common (5-10% worldwide; 7.5% in Taiwan),~     clinically heterogeneous, impairing disorder. Despite the abundance of research on ADHD, the~     vast majority of samples have been limited to Caucasians; there is limited information about~     the expressions, patterns, correlates, and outcomes for ADHD in the Taiwanese population.~      Specific Aims:~        1. to investigate the neuropsychological functioning, and psychiatric, academic, and social~          outcomes of ADHD at adolescence;~        2. to examine the psychopathology and neuropsychological functioning among parents and~          siblings of ADHD probands;~        3. to determine the components of ADHD and neuropsychological functioning with the greatest~          familial recurrence risks; and~        4. to validate the classification of ADHD and comorbid subtypes of ADHD using psychosocial,~          familial, neuropsychological and longitudinal data.~      Subjects and Methods: This 5-year proposal consists of two parts: (1) a 3 year-retrospective~     cohort study and family study design; and (2) a 2 year-prospective cohort study design.~     Several Chinese version of rating scales will be prepared in the first 6 months. The sample~     will consist of probands with (n=180) and without (n=90) ADHD, ages 11-16, recruited from the~     Children's Mental Health Center, NTUH and an epidemiological study. The ADHD diagnosis has~     been made 3-6 years ago prior to recruitment. Probands and their parents will be assessed~     using the following measures (n=810) in the first 3 years. Only probands will be reassessed~     in the last 2 years. The measures will include a psychiatric interview using K-SADS-E and~     self-reports covering the individual and familial/environmental domains; and~     neuropsychological tests (WISC-III, CPT, WCST, CANTAB). The informants include probands and~     their parents and teachers.~      Long-term Objectives: The long-term objectives are to identify the endophenotypes that are~     close to the biological expression of genes underlying ADHD, to determine the familial~     aggregation and its specificity regarding the components of ADHD, and neuropsychological~     deficit, and to identify the impact of ADHD on academic, psychiatric, family, and social~     outcomes; and to identify a cohort of families with ADHD for future neuroimaging,~     neurophysiological, and molecular genetic studies.~   "
239689|NCT00417768|"~     To determine if instillation of tissue plasminogen activator into a percutaneously drained~     intra-abdominal abscess cavity results in faster resolution of the abscess compared to normal~     standard of care.~   "
239690|NCT00417755|"~     COPD patients requiring ventilation may benefit from invasive or non invasive ventilation.~     Non invasive ventilation is often incompatible with oral or enteral feding, due to gastric~     dilatation and full mask therapy. At the other hand, invasive ventilation is associated with~     incomplete enteral feeding and nutrition requirements are not reached. The aim of the study~     was to compare the feeding delivery of COPD patients receiving invasive or non invasive~     mechanical ventilation.~   "
239691|NCT00417742|"~     PROJECT CHEER is a randomized controlled trial designed to test the effectiveness of a~     comprehensive focused approach to headache care. Three institutions are collaborating in this~     trial by establishing special Headache Programs that can provide individualized treatment and~     follow-up: Duke University Medical Center in Durham, NC; Thomas Jefferson University in~     Philadelphia, PA; and Kaiser Permanente in San Diego, CA. Support and oversight are provided~     by the U.S. Agency for Healthcare Research and Quality.~      HEADACHE sufferers age 18 and over whose headaches interfere with their ability to work,~     study or enjoy life are eligible for this trial. Half of the enrolled individuals will be~     selected at random to receive care in the Headache Program and half will continue to receive~     care as usual from their primary care providers.~      EVALUATION is an important part of this project. Every participant completes a screening~     interview and survey at the time of enrollment. The initial evaluation will provide an~     accurate diagnosis of headache type(s). The results of this evaluation will be reported to~     the primary care provider and may help to provide usual care. Subjects assigned to the~     Headache Program are further evaluated by the program manager in consultation with a headache~     specialist.~      EDUCATION in headache care is provided to participants assigned to the Headache Program.~      The classes include suggestions on diet and lifestyle as well as a review of medication use.~      Note: The above is excerpted from the flyer we distributed to recruit patients to the trial.~   "
239692|NCT00417729|"~     To compare effect of acarbose versus glibenclamide treatment on mean amplitude of glyclemic~     excursion and oxidative stress in diabetes individuals who failed to control their glucose by~     metformin therapy alone~   "
239693|NCT00417716|"~     Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema~   "
241640|NCT00391703|"~     This is an add-on, randomized, open label, clinical trial that evaluates the use of~     quadriceps electrostimulation as an additional retraining procedure in patients suffering~     from cystic fibrosis.~   "
239694|NCT00417703|"~     This study will quantify the intraocular pressure elevation in the immediate time period~     following intravitreous injection. With more widespread use of intravitreous injections in~     patients that may require several injections per year, it is important to document the sudden~     increase in intraocular pressure, including the maximum intraocular pressure and the time~     required for the intraocular pressure to return to baseline. This data may be useful in~     stimulating additional studies to evaluate the long term ocular effects of repeated~     intravitreous injections.~      We hypothesize that the intraocular pressure increases significantly following intravitreous~     injection and then returns to baseline during the initial thirty minutes following~     ranibizumab injection.~   "
239695|NCT00417690|"~     The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release~     oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks~     followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's~     disease.~   "
239696|NCT00417677|"~     This study is being conducted to determine the Maximum Tolerated Dose (MTD) and efficacy of~     the combined treatment of Temsirolimus and Sunitinib for the treatment of Advanced Kidney~     Cancer~   "
239697|NCT00417664|"~     The purpose of this study is to determine whether the use of dexmedetomidine, a selective~     α2-adrenergic receptor agonist with sedative, analgesic, and antinociceptive properties,~     would be associated with a lower incidence of delirium when compared to propofol and~     midazolam. We hypothesize that sedation with dexmedetomidine following cardiac surgery with~     CPB will be associated with a lower incidence of postoperative delirium.~   "
239698|NCT00417651|"~     The purpose of this study is to evaluate whether creating a gastrotomy (hole in the stomach)~     during gastric surgery increases a patient's risk of intra-abdominal infection.~      We hypothesize that a gastrotomy does not contaminate the abdomen with clinically significant~     bacterial pathogens.~   "
239699|NCT00417638|"~     Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Control™~     System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior~     myocardial infarction when used in combination with cold saline as an adjunct to immediate~     percutaneous coronary intervention (PCI) in patients with an occluded infarct-related artery.~   "
239700|NCT00417625|"~     This study will test the accuracy of magnetic resonance imaging (MRI) in measuring cardiac~     perfusion (blood flow). MRI of the heart can measure blood flow to heart muscle, but~     collateral coronary arteries (vessels that supply blood to the heart muscle) may reduce the~     accuracy of the measurements. This study will perform special measurements of coronary artery~     flow and pressure in patients undergoing heart catheterization and catheter-based treatment~     (angioplasty and stenting) in order to compare for accuracy with cardiac MRI.~      Patients 21 years of age and older with coronary artery blockage may be eligible for this~     study. All participants undergo cardiac MRI, to produce images of the heart, as well as~     special invasive blood flow testing during heart catheterization, angioplasty, and stenting.~      During MRI, the subject lies on a table that can slide in and out of the scanner (a narrow~     cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the~     scanning process. The procedure lasts about 45 to 90 minutes. Since the heart moves during~     breathing, subjects are asked to hold their breath intermittently for about 5-20 seconds. A~     medicine called dipyridamole is injected through a vein in the subject's arm to increase~     blood flow to the coronary arteries and help detect blockages. Pictures are taken of the~     heart before, during, and after the dipyridamole injection. Another medicine called~     gadolinium is also given through a vein. This medicine brightens the images to measure blood~     flow.~      During a separate catheterization, angioplasty, and stenting procedure, subjects undergo~     additional invasive tests. The additional tests use a special guidewire to measure coronary~     artery pressure and blood flow, as well as a special ultrasound to look inside the artery.~      Patients have a repeat MRI about 2 months after the catheterization.~   "
239701|NCT00417612|"~     The purpose of this study is to determine the effectiveness of paricalcitol, a form of~     synthetic vitamin D, in lowering parathyroid hormone (PTH) levels and reducing disease~     symptoms in children and adults with X-linked hypophosphatemic (XLH) rickets.~   "
239702|NCT00417599|"~     The prevalence of overweight in the United States Air Force (USAF) is about 22%. The~     objective of this study is to compare the effectiveness of a minimal contact behavioral~     therapy plus usual care group(MCBT+UC) using a controlled experimental comparison of usual~     care(UC). Subjects are USAF personnel who are 5lbs below their Maximum Allowable Weight (MAW)~     and heavier. The primary hypothesis is that: MCBT+UC will have significant weight loss as~     compared to UC.~   "
239703|NCT00417586|"~     Carotid stenosis, a condition in which plaque builds up inside the arteries of the neck and~     blocks blood flow to the brain, is one common cause of stroke. This study will evaluate the~     cost-effectiveness of using a new, specialized ultrasound device to screen individuals who~     are at risk for carotid stenosis.~   "
239704|NCT00417573|"~     -  This is the first study, that we are aware of, that will evaluate the efficacy of IgIV~          in patients with IgG subclass deficiency.~        -  Will provide data for further collaboration in extending study to involve other~          immunological centers in the United States to study patients with similar disease.~   "
239705|NCT00417560|"~     This is a single center, open-label, Phase I/II study in up to 100 adult subjects, aged 18~     years and older who are at occupational risk of exposure to live H5N1 viruses. This study is~     designed to investigate the safety, reactogenicity, and immunogenicity of two 90 µg doses of~     an investigational inactivated influenza A/H5N1 virus vaccine given approximately 28 days~     apart. A blood sample will be collected for immunogenicity evaluation prior to each~     vaccination. Subjects will maintain a memory aid (appendix C4 and C13) to record oral~     temperature and systemic and local AEs for 7 days after immunization. Subjects will be~     encouraged to take their temperature around the same time each day. All subjects will receive~     a safety follow-up telephone call at 1 to 3 days after each vaccination (approximately Day 2)~     to elicit any AE and concomitant medication information. Subjects will return to the clinic 7~     days after each vaccination for assessment of AEs and concomitant medications, a targeted~     physical examination (if indicated), and review of the memory aid. At approximately Day 28~     after the first vaccination, subjects will return to the clinic for evaluation of vital~     signs, blood sample collection and safety follow-up, confirmation of eligibility criteria and~     a second vaccination. Safety follow-up will be identical to that performed after the first~     vaccination. At approximately Day 56 (or about 28 days after the second vaccination),~     subjects will return to the clinic for immunogenicity blood sample collection, AE and~     concomitant medication assessment, and targeted physical examination and vital sign~     assessment (if indicated). At approximately Day 180 (6 months after the first vaccination),~     subjects will return to the clinic for a final immunogenicity blood sample collection and~     safety assessment.~      Blood samples collected prior to each vaccination (Days 0 and 28) and on Days 56 and 180~     after the first vaccination will be tested at the CDC Influenza Division Laboratory for the~     levels of neutralizing and HAI antibodies and CMI responses.~      The primary outcome measures will be the frequencies and severities of AEs and the GMTS and~     proportions of subjects who achieve 4-fold rises in serum neutralizing and HAI titers against~     the influenza A/H5N1 virus on Day 56. Serum HAI and neutralizing antibody responses~     (including frequencies of 4 fold or greater rise in titer; GMTs; and proportions of subjects~     achieving protective titers of neutralizing antibody 1 month and 6 months after first dose)~     will also be assessed. A secondary outcome measure will be CMI responses evaluated 1 month~     after the receipt of each dose of vaccine and 6 months after the receipt of the first dose of~     vaccine.~   "
239706|NCT00417547|"~     The aim of this research is to examine the social, psychological and Islamic veil practicing~     (IVP), non-complete IVP and Inconsiderate to IVP correlates of body mass index (BMI) status~     in a women population. It is hypothesized that women who are IVP would differ on depression,~     and social variables compared with their non-practicing peers.~   "
239707|NCT00417534|"~     The aim of this study is to identify genetic loci,or gene variations contributing to~     inflammation and to the development of CHD. We will compare coronary angiogram results to~     genetic findings within coronary artery disease patients and in patients with normal~     coronaries.~   "
239711|NCT00417482|"~     In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis~     and/or agitation/aggression, the relapse risk after discontinuation is not established. AD~     patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone~     treatment (Phase A). Responders are then randomized, double-blind, to one of three arms in~     Phase B: (1) continuation risperidone for 32 weeks, (2) risperidone for 16 weeks followed by~     placebo for 16 weeks, (3) placebo for 32 weeks. The primary outcome is time to relapse of~     psychosis/agitation.~   "
239712|NCT00417469|"~     The purpose of this research study is to compare subject comfort during and after injection~     with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an~     FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield,~     NJ). NADGL is a new product (not FDA approved) with lidocaine and is also manufactured by~     Genzyme Biosurgery. We do not know which of these treatments results in less pain during and~     after injection. The safety of NADGL is also being studied.~   "
239713|NCT00417456|"~     The purpose of this study is to test the efficacy, timeliness, and user satisfaction of an~     online E-Visit application that uses store-and-forward technology for acne patients~     requiring dermatologic care for their condition. Hypotheses:~        1. That an E-Visit is an effective alternative to in-person clinic care for patients with~          mild to severe facial acne.~        2. That providers and patients will be satisfied with this model.~        3. That mean wait times for new and return visits will be reduced through the E-Visit~          model.~        4. That this prototype for care will improve clinic workflow, offer additional patient~          access, and allow urgent cases to be seen earlier.~   "
239714|NCT00417443|"~     We propose performing a study in which we compare the effects of bupivacaine and fentanyl~     with a different drug combination − bupivacaine and clonidine. The principal research~     questions of the study are:~        1. To compare the effect of clonidine (with bupivacaine), injected into the epidural space~          on the extent of hyperalgesia (abnormal pain/sensitivity in the uninjured skin~          surrounding the operation site) in patients undergoing operations for bowel disease,~          with that of fentanyl (with bupivacaine).~        2. To compare the effect of clonidine (with bupivacaine), injected into the epidural space~          on the incidence of chronic pain 6 months after surgery for bowel disease, with that of~          fentanyl (with bupivacaine).~   "
239715|NCT00417430|"~     SLE(Systemic Lupus Erythematosus) is an autoimmune disese that primarily occurs in women(9:1~     compared to men). The disease is activated by genetic and environmental factors, yet the~     female gender is the strongest risk factor. The sex hormone estrogen has been proven in the~     past to be an enhancer of the immune response. Estrogen serves as a ligand for two specific~     receptor proteins. Lab studies that we have already done have shown estrogen significantly~     increases these two ligands in the T cells from SLE females, but not in T cells from normal~     women. These estrogen-dependent increases are blocked by the estrogen receptor antagonist ICI~     182,780. The objective of this research is to investigate if ICI 182,780 alters disease~     progression and/or activity in females with SLE and may provide a new treatment for women~     with SLE. This is based on previous work we have done.~   "
239716|NCT00417417|"~     This study will determine whether an experimental drug called Rilonacept can improve artery~     function in patients with atherosclerosis, a disease in which fatty deposits in arteries~     cause the vessels to stiffen, impeding blood flow. Atherosclerosis is believed to be caused~     in part by inflammation. Rilonacept blocks production of a protein called CRP, which, in high~     levels in the blood is associated with increased inflammation. Patients with coronary artery~     disease who have elevated blood levels of CRP are at increased risk of heart attack, heart~     failure and sudden death compared with people who have lower levels of the protein.~      Patients 18 years of age and older with atherosclerotic coronary artery disease with a CRP~     level between 2 and 10 mg/L may be eligible for this study.~      Patients are randomly assigned to receive four doses of either Rilonacept or placebo, given~     at 2-week intervals as injections under the skin. In addition to treatment, patients undergo~     the following procedures during eight visits to the NIH Clinical Center:~        -  Visit 1 (screening visit): Medical history, measurement of vital signs (temperature,~          blood pressure, heart rate and breathing rate), electrocardiogram (EKG) and blood tests.~        -  Visit 2: Blood tests, chest X-ray, treadmill exercise testing, tuberculin skin test,~          brachial artery flow-mediated dilation. Brachial artery flow-mediated dilation is used~          to measure how well the brachial artery (artery inside the elbow) dilates. An ultrasound~          device placed just above the elbow measures the size of the brachial artery and the flow~          of blood through it before and after a pressure cuff is inflated around the forearm.~        -  Visit 3: Injection of study drug.~        -  Visits 4, 5, and 6: Review of any changes in health or medical treatment, measurement of~          vital signs, blood tests, EKG, injection of study drug.~        -  Visit 7: Review of any changes in health or medical treatment, measurement of vital~          signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated~          dilation.~        -  Visit 8: Review of any changes in health or medical treatment, measurement of vital~          signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated~          dilation.~   "
239717|NCT00417404|"~     Vitamin A is important for the development of healthy eyes and lungs. Very low birth weight~     premature babies have low body stores of vitamin A and are prone to diseases of the eye and~     lungs. Previous work has shown that intramuscular (IM) vitamin A reduces the number of babies~     who require prolonged oxygen therapy, and may also reduce the number of babies affected by~     retinopathy of prematurity (ROP)). There is also some evidence that the conjunctiva shows~     signs of deficiency of vitamin A in premature infants, particularly those who develop ROP.~     Our own work here in Glasgow suggests that, compared to babies born at full term, premature~     babies' eyes are less sensitive to light and we believe that this may reflect shortage of~     vitamin A in the eye. This study will examine the effects upon the eye of giving extra~     intramuscular vitamin A to very low birth weight, premature infants. We will also measure~     blood levels of vitamin A and calculate liver stores of this nutrient.~   "
239718|NCT00417391|"~     The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of~     1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's~     disease.~   "
239719|NCT00417378|"~     The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist~     device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in~     patients with cardiogenic shock due to left ventricular failure following an acute coronary~     syndrome (myocardial infarction).~   "
239720|NCT00417365|"~     Comparing the new Stainless Steel WaterWorks® douching device to a commercially available~     douching device using just water for safety and efficacy of odor abatement.~   "
239750|NCT00416975|"~     RATIONALE: Education, based on a patient's risk factors, may help promote breast cancer~     screening in healthy women.~      PURPOSE: This randomized clinical trial is studying individualized risk-based education to~     see how well it promotes breast cancer screening in healthy women compared to standard~     education.~   "
239751|NCT00416962|"~     This study is designed to assess the safety and pharmacokinetic effects of oseltamivir~     administration alone or in combination with amantadine in healthy volunteers.~   "
239721|NCT00417352|"~     Current improvements of the design of the upper limb prosthesis include advanced technology~     in control systems and electronic circuitry that mimic human motion and improve function of~     the prosthesis. Often times these improvements require large amounts of power, circuitry and~     excess mass distally along the prosthesis that may require greater effort from the user. Poor~     function of an upper limb prosthesis may cause awkward compensatory motion. Aberrant~     movements, such as these compensatory movements are known to cause greater stress to~     remaining joints. Amputees are forced to decide if the extra function provided by the~     advanced electronics is worth carrying the extra mass which may cause fatigue, socket issues~     and greater stress on the remaining joints. An example is the wrist rotator component of an~     upper limb prosthesis which may allow greater function and reduce compensatory motion, but~     adds mass distally, potentially causing greater torques on remaining joints.~      GOALS OF THE STUDY:~      There are two main goals of this study:~        1. to determine the impact of an upper limb prosthesis without a wrist rotator on the~          compensatory motion and torques in the remaining joints during common tasks~        2. to determine the impact of the location (distally or proximally) of a wrist rotator on a~          upper limb prosthesis on the compensatory motion during common tasks~      HYPOTHESES:~        1. There will be a statistically significant difference in range of motion of the upper~          limb joints between healthy subjects, braced subjects and upper limb amputees during~          four common tasks.~        2. There will be a statistically significant difference in joint upper limb joint torques~          between healthy subjects, braced subjects and upper limb amputees during three common~          tasks.~        3. There will be a statistically significant difference in upper limb angles and joint~          torques between mass added distally and mass added proximally during common tasks.~   "
239722|NCT00417339|"~     Study on intradialytic kinetics of protein-bound uremic retention solutes during long~     nocturnal hemodialysis~   "
239723|NCT00417326|"~     The purpose of this study is to determine the safety and efficacy of ONO-5046Na in patients~     with acute respiratory failure associated with community-acquired pneumonia~   "
239724|NCT00417313|"~     The purpose of this study is to investigate the feasibility, effectiveness, and duration of~     treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis~     (OA)-associated chronic knee pain.~   "
239725|NCT00417300|"~     This study will evaluate the comparative effectiveness of prolonged exposure therapy and~     client centered therapy in treating adolescents with post-traumatic stress disorder related~     to childhood sexual abuse or assault.~   "
239726|NCT00417287|"~     This study is being conducted to evaluate the clinical efficacy, biologic activity~     (inhibition of PX-12 target thioredoxin-1) and effects of an expired metabolite of PX-12 in~     patients with advanced pancreatic cancer.~   "
239727|NCT00417274|"~     The purpose of this study is to determine whether quinacrine is effective in the treatment of~     Androgen-Independent Prostate Cancer.~   "
239728|NCT00417261|"~     This is a first-in-human study and is designed to evaluate the safety, tolerability,~     pharmacodynamic and pharmacokinetic effects of a single and multiple-doses of ATF936 and~     AXT914 administered orally in healthy subjects.~   "
239729|NCT00417248|"~     Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety~     and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.~   "
239730|NCT00417235|"~     The purpose of this study is to determine whether a catheter dressing every 7th day is not~     inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are~     effective in preventing catheter-related infections in ICUs.~   "
239731|NCT00417222|"~     The purpose of this study is to investigate whether an angiotensin II receptor blocker~     (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity~     in hypertensive patients with stable chronic heart failure.~   "
239732|NCT00417209|"~     The purpose of this study is to compare the efficacy and the safety Larotaxel administered as~     single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients~     with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or~     metastatic) previously treated with gemcitabine based therapy.~   "
239733|NCT00417196|"~     This study is designed to evaluate the safety, pharmacodynamic and pharmacokinetic effects of~     individual escalating intravenous doses of QAX576 in healthy volunteers.~   "
239734|NCT00417183|"~     The purpose of this study is to compare the efficacy of two controlled ovarian stimulation~     protocols, the GnRH agonist protocol, widely known as the long protocol, and the flexible~     GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile~     patients receiving IVF treatment.~   "
239735|NCT00417170|"~     The purpose of this study was to determine the effects of Aliskiren on insulin resistance~     (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic~     syndrome. The efficacy of Aliskiren was compared to Amlodipine.~   "
239736|NCT00417157|"~     The purpose of this study is to evaluate the effectiveness of a modified natural cycle in~     patients with previous poor response to infertility drugs and high basal FSH, prior to~     proceeding to oocyte donation or abandoning fertility treatment.~   "
239737|NCT00417144|"~     The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS~     patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation~     during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the~     occurrence and severity of OHSS compared to the GnRH agonist protocol.~   "
239738|NCT00417131|"~     Islets of Langerhans intended for clinical transplantation are labelled with a radioactive~     tracer. The tracer is retained in viable cells of the transplant. At infusion~     (transplantation) of the islets into the portal vein the tracer can be followed for two hours~     with positron emission tomography (PET). Imaging and calculations can give estimates of the~     proportion of surveying islets and the rate of early destruction. Also the distribution of~     the islets into the liver can be viewed.~   "
239739|NCT00417118|"~     The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to~     placebo in patients with generalized anxiety disorder. The secondary objectives are to~     evaluate the efficacy of saredutant on disability and quality of life in patients with~     generalized anxiety disorder, and to evaluate blood levels of saredutant.~   "
239752|NCT00416949|"~     RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation.~      PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I~     131 works in treating patients with thyroid cancer.~   "
239753|NCT00416936|"~     The use of mobile phones in the operating room (OR) has become widespread, because of the~     lack of reports on serious problems. Since mobile phones are used in close body contact and~     since, as for most non-medical electronic equipment, there are no cleaning guidelines that~     meet hospital standards, the hygiene risk involved in using mobile phones in the OR has not~     yet been determined.~   "
239922|NCT00414661|"~     The purpose of this study is to follow the health of subjects who have previously been~     enrolled in studies of CP-690,550 for treatment of their rheumatoid arthritis. Subjects are~     only eligible for this study after they have completed all participation in other studies of~     CP-690,550.~   "
239740|NCT00417105|"~     Although remarkable progress has been made, chronic kidney disease still poses a major burden~     on both individual patients, as well as on society as a whole. There is a strong inverse~     relationship between decreasing renal function, as estimated by glomerular filtration rate,~     and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain~     to be elucidated. Uremic toxins might play an important role.~      In the course of decreasing renal function the concentration of numerous intracellular and~     extracellular compounds vary from the non-uremic state. But still increasing number of uremic~     retention solutes are being identified. Renal replacement strategies aim to remove~     potentially harmful substances from the body. Traditionally much attention has been paid to~     small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of~     the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the~     level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) -~     seem not to be advantageous with regard to patient outcome. These findings may point to the~     importance of other distinct groups of uremic retention solutes. In view of the data~     described above, protein-bound solutes might be good candidates.~      Several advantages of long duration hemodialysis have been observed, including a better~     control of blood pressure by decreasing extracellular fluid volume, lowering peripheral~     vascular resistance and improving endothelium-dependent and -independent vasodilation. A~     normalization of heart rate variability and improvement of left-ventricular function was~     noted as well. Furthermore, anemia control has been shown to be easier and several~     nutritional parameters improved in patients treated with long duration HD. The therapy~     results in higher small water-soluble solute removal, phosphate removal and greater~     elimination of larger molecules (e.g. β2-microglobulin).~      It seems an appealing question whether a better control of the serum levels of protein-bound~     solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another~     advantage of this therapeutic modality, or may even in part explain the better outcome of~     patients treated this way.~      The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to~     serum concentrations of several protein bound uremic toxins, as well as solute removal.~   "
239741|NCT00417092|"~     The purpose of this study is to determine which pacing mode after coronary artery bypass~     grafting in patients with reduced left ventricular function is hemodynamically favorable.~   "
239742|NCT00417079|"~     This is a randomized, open-label, multi-center study comparing the safety and efficacy of~     XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone~     refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen.~     The primary objective is overall survival. Secondary objectives include progression free~     survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain~     response/progression, overall safety, and pharmacokinetics. Patients will be treated until~     disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients~     will have long-term follow-up for a maximum of up to 2 years.~   "
239743|NCT00417066|"~     The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist~     protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian~     stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes~     compared to the flare up protocol in this group of patients.~   "
239744|NCT00417053|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed. Sometimes, after surgery, the tumor may not need more treatment until it~     progresses. In this case, observation may be sufficient. It is not yet known which~     combination chemotherapy regimen given together with surgery, with or without autologous bone~     marrow or peripheral stem cell transplant, is more effective in treating newly diagnosed~     neuroblastoma.~      PURPOSE: This phase III trial is studying combination chemotherapy to see which regimen given~     together with surgery, with or without autologous bone marrow or peripheral stem cell~     transplant, works in treating infants with newly diagnosed neuroblastoma.~   "
239745|NCT00417040|"~     This pilot clinical trial studies how well using the internet to collect symptoms and the~     ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia~     Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting~     room computer to report their symptoms and their ability to carry out daily activities may~     help doctors understand a patient's use of a computer to report symptoms.~   "
239746|NCT00417027|"~     Studies suggest that administration of maintenance epidural solutions as programmed or~     automated intermittent boluses, rather than continuous infusions, result in lower bupivacaine~     consumption, decreased need for manual boluses by the anesthesiologist, and greater patient~     satisfaction. In this technique, the epidural maintenance dose is administered as a bolus by~     the infusion pump at regular intervals instead of as a continuous infusion. However, the~     optimal combination of bolus volume and dosing interval has not been determined. At one end~     of the spectrum, a small volume and short bolus dose interval will likely behave like a~     continuous infusion. At the other end of the spectrum, a large volume and long bolus dose~     interval may lead to an increased incidence of breakthrough pain. The purpose of this~     randomized, double-blind trial was to determine how manipulation of the programmed~     intermittent time interval and volume influences total drug use, quality of analgesia, and~     patient satisfaction during maintenance of labor analgesia. We hypothesized that manipulation~     of the programmed intermittent bolus time interval and volume during the maintenance of~     epidural labor analgesia influences total drug use, quality of analgesia and patient~     satisfaction.~   "
239747|NCT00417014|"~     RATIONALE: Drugs used in chemotherapy, such as chlorambucil, vinblastine, procarbazine, and~     prednisolone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to~     kill cancer cells. Giving more than one drug (combination chemotherapy) together with~     radiation therapy may kill more cancer cells.~      PURPOSE: This clinical trial is studying how well giving combination chemotherapy and/or~     radiation therapy works in treating young patients with Hodgkin's lymphoma.~   "
239748|NCT00417001|"~     Colonoscopy for investigation of lower gastrointestinal complaints or for colon cancer~     screening is one of the more frequent procedures performed by the Divisions of General~     Surgery and Gastroenterology. Traditionally, this has been performed while under conscious~     sedation (medication induced) which may improve patient acceptance and tolerance of the~     procedure but adds to the operative risk of the procedure. The investigators propose a~     randomized prospective blinded trial to assess the utility of adding pleasing olfactory~     stimulation to the inhaled oxygen during the conscious sedation for colonoscopy in an effort~     to reduce the total doses of sedatives required while maintaining a similar level of~     sedation. This may decrease the overall period of recovery for the patient, increase the~     number of procedures which may be accomplished, and decrease the potential complications~     related to conscious sedation.~   "
239754|NCT00416923|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Giving rituximab intrathecally may~     be an effective treatment for recurrent CNS lymphoma.~      PURPOSE: This phase I trial is studying the side effects and best dose of intrathecal~     rituximab in treating patients with recurrent CNS lymphoma.~   "
239755|NCT00416910|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, mitoxantrone, and~     cyclophosphamide, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more cancer cells. Colony stimulating factors, such as G-CSF, may~     increase the number of immune cells found in bone marrow or peripheral blood and may help the~     immune system recover from the side effects of combination chemotherapy. It is not yet known~     whether giving combination chemotherapy alone is more effective than combination chemotherapy~     together with G-CSF in treating patients with chronic lymphocytic leukemia.~      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy together~     with G-CSF to see how well it works compared to giving combination chemotherapy alone in~     treating patients with relapsed stage I, stage II, stage III, or stage IV chronic lymphocytic~     leukemia.~   "
239756|NCT00416897|"~     RATIONALE: Dexamethasone is used to treat multiple myeloma. Drugs used in chemotherapy may~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Plasma exchange is a process in which certain cells are separated from the plasma~     in the blood by a machine and then only the cells are returned to the patient. Dexamethasone~     and plasma exchange may be an effective treatment for acute kidney failure caused by multiple~     myeloma. It is not yet known whether giving dexamethasone and chemotherapy together with~     plasma exchange is more effective than giving dexamethasone and chemotherapy alone in~     treating patients with multiple myeloma and acute kidney failure.~      PURPOSE: This randomized phase III trial is studying dexamethasone, chemotherapy, and plasma~     exchange to see how well they work compared with dexamethasone and chemotherapy alone in~     treating patients with newly diagnosed multiple myeloma and acute kidney failure.~   "
239757|NCT00416884|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation~     (TBI) before a donor stem cell transplant helps stop the growth of cancer cells. It also~     stops the patient's immune system from rejecting the donor's stem cells. The donated stem~     cells may replace the patient's immune system and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte~     infusion) that have been treated in the laboratory after the transplant may help increase~     this effect. Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving cyclosporine and alemtuzumab, and removing the T~     lymphocyte cells(T cells) from the donor cells before transplant, may stop this from~     happening.~      PURPOSE: This clinical trial is studying how well giving fludarabine, alemtuzumab, and~     total-body irradiation together with donor stem cell transplant and donor white blood cell~     (WBC) infusion works in treating patients with chronic phase chronic myelogenous leukemia~     (CML) that did not respond to previous imatinib mesylate.~   "
239758|NCT00416871|"~     RATIONALE: Biological therapies, such as interleukin-2 and interferon, may stimulate the~     immune system in different ways and stop tumor cells from growing. It is not yet known~     whether interleukin-2 given by infusion is more effective than interleukin-2 given by~     injection when combined with interferon in treating metastatic kidney cancer.~      PURPOSE: This randomized phase III trial is studying interleukin-2 given by infusion to see~     how well it works compared to interleukin-2 given by injection when combined with interferon~     in treating patients with metastatic kidney cancer.~   "
239759|NCT00416858|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     radiation therapy together with combination chemotherapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving these~     treatments after surgery may kill any tumor cells that remain.~      PURPOSE: This randomized phase III trial is studying radiation therapy together with~     combination chemotherapy to see how well they work with or without surgery in treating~     patients with locally advanced esophageal cancer that can be removed by surgery.~   "
239760|NCT00416845|"~     This study is designed to assess the effects of two doses of FTY720 on lung (pulmonary) and~     cardiac (heart) functions in healthy volunteers.~   "
239761|NCT00416832|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill cancer cells. Giving combination chemotherapy together with~     radiation therapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving combination~     chemotherapy together with radiation therapy works in treating young patients with Hodgkin's~     lymphoma.~   "
239762|NCT00416819|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Giving rituximab together with combination chemotherapy~     may kill more cancer cells.~      PURPOSE: This clinical trial is studying the side effects and best ways to give combination~     chemotherapy together with rituximab in treating patients with newly diagnosed primary CNS~     lymphoma.~   "
239763|NCT00416793|"~     This phase II trial is studying how well giving bortezomib together with carboplatin works in~     treating patients with metastatic pancreatic cancer. Bortezomib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as carboplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving bortezomib together with~     carboplatin may kill more tumor cells.~   "
239782|NCT00416546|"~     This is a study to assess the safety effects after multiple doses of AEB071 in healthy~     volunteers and to compare the ethnicity, metabolic, and safety effects between Caucasian and~     Japanese healthy subjects receiving single and multiple doses of AEB071.~   "
239764|NCT00416780|"~     RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support~     and to learn to reduce stress may help patients cope with their diagnosis, have a better~     quality of life, and live more comfortably.~      PURPOSE: This randomized clinical trial is studying how well psychosocial support works in~     treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.~   "
239765|NCT00416767|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works as~     first-line therapy in treating patients with locally advanced or metastatic neuroendocrine~     tumors of the duodenum or pancreas that cannot be removed by surgery.~   "
239766|NCT00416754|"~     RATIONALE: Genetic counseling and using an interactive computer program may help women at~     risk for breast cancer make medical decisions about treatment.~      PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how~     well it works when given together with or without a medical decision-making computer program~     in women at risk for BRCA1 or BRCA2 mutations.~   "
239767|NCT00416741|"~     The objective of this protocol is to improve awareness, treatment, and control of metabolic~     syndrome, within primary prevention of cardiovascular disease, by implementing guidelines,~     after training of the participating physicians.~   "
239768|NCT00416728|"~     This study will assess the bioavailability of aliskiren and valsartan as a single tablet~     compared to the same doses of the two drugs given as two separate tablets in healthy~     subjects.~   "
239769|NCT00416715|"~     This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint~     stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning~     about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients~     receiving letrozole for breast cancer may help doctors plan treatment and may help patients~     live more comfortably~   "
239770|NCT00416702|"~     This study is designed to evaluate the safety and pharmacokinetic effects of indacaterol in~     subjects with impaired liver function in comparison with healthy subjects~   "
239771|NCT00416689|"~     RATIONALE: Understanding how nausea or vomiting caused by chemotherapy effects a patient's~     treatment decisions may help doctors plan better cancer treatment and may help patients live~     more comfortably.~      PURPOSE: This clinical trial is studying nausea or vomiting in patients who are receiving~     chemotherapy for breast cancer or lung cancer.~   "
239772|NCT00416676|"~     RATIONALE: Drugs used in chemotherapy, such as vincristine, cyclophosphamide, cisplatin,~     etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving combination chemotherapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving combination~     chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after~     surgery.~      PURPOSE: This phase III trial is studying how well giving combination chemotherapy and~     surgery with or without radiation therapy works in treating patients with stage 2 or stage 3~     neuroblastoma.~   "
239773|NCT00416663|"~     Evaluation of an intracoronary injection of ex-vivo generated autologous Angiogenic Cells~     Precursors (ACPs) to treat patients suffering from severe angina not responsive to maximal~     drug treatment or not willing or without option of undergoing percutaneous coronary~     intervention (PCI) or coronary artery bypass graft surgery (CABG). The use of ACPs aims to~     promote the formation of new vascularization and thus viable myocardial tissue.~   "
239774|NCT00416650|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with~     advanced non-small cell lung cancer.~   "
239775|NCT00416637|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others~     interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor .~      PURPOSE: This phase I trial is studying how well bevacizumab works in treating patients with~     advanced solid tumors.~   "
239776|NCT00416624|"~     RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells.~     They are used to treat anemia caused by chemotherapy in patients with cancer.~      PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa~     or darbepoetin alfa to compare how well they work in treating patients with anemia caused by~     chemotherapy.~   "
239777|NCT00416611|"~     The objective of this protocol is to improve awareness, treatment, and control of arterial~     hypertension, within primary prevention of target organ damage, by implementing guidelines,~     after training of the participating physicians.~   "
239778|NCT00416598|"~     This phase II trial is studying the side effects and how well decitabine works when given as~     maintenance therapy after standard therapy in treating patients with previously untreated~     acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin,~     etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving decitabine as~     maintenance therapy after standard therapy may keep cancer cells from coming back.~   "
239779|NCT00416585|"~     serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with~     isotretinoin for sever acne~   "
239780|NCT00416572|"~     RATIONALE: Educational programs may improve coping and quality of life in younger women who~     have recently been treated for early-stage breast cancer.~      PURPOSE: To conduct a clinical trial to determine if an educational intervention and a~     nutritional intervention could enhance physical and psychological functioning among younger~     women completing treatment for early-stage breast cancer.~   "
239781|NCT00416559|"~     RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment~     until symptoms appear or change. Observation may help doctors see how effective surgery is in~     treating neuroblastoma.~      PURPOSE: This phase II trial is studying how well surgery alone works in treating young~     patients with localized neuroblastoma.~   "
239783|NCT00416533|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and~     prednisone together works in treating patients with advanced prostate cancer that has not~     responded to hormone therapy.~   "
239784|NCT00416520|"~     This is a phase III multi-centre study in three periods: the first period is a phosphate~     binder washout for 4 weeks, the second period is an open-label, randomised, parallel group,~     flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with~     placebo for 4 weeks.~   "
239785|NCT00416507|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, fluorouracil, and cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving more than one drug (combination chemotherapy) together with radiation therapy may kill~     more tumor cells. It is not yet known which treatment regimen is more effective for~     pancreatic cancer.~      PURPOSE: This randomized phase III trial is studying gemcitabine, fluorouracil, cisplatin,~     and radiation therapy to see how well they work compared to gemcitabine alone in treating~     patients with nonmetastatic pancreatic cancer that cannot be removed by surgery.~   "
239786|NCT00416494|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some find tumor cells and kill them or carry tumor-killing substances to~     them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may~     also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine~     and oxaliplatin together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine~     together with bevacizumab works in treating patients with metastatic or recurrent colorectal~     cancer.~   "
239787|NCT00416481|"~     RATIONALE: Questionnaires that measure the ability of older patients to think, learn,~     remember, and make judgments and carry out daily activities may improve the ability to plan~     treatment for patients with cancer.~      PURPOSE: This clinical trial is studying ways to assess older patients with cancer.~   "
239788|NCT00416468|"~     This study will assess the bioavailability of aliskiren and valsartan as a single tablet~     compared to the same doses of the two drugs given as two separate tablets in healthy~     subjects.~   "
239789|NCT00416455|"~     This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and~     ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and~     radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial~     cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography~     (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging~     (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or~     endometrial cancer.~   "
239790|NCT00416442|"~     This study is designed to evaluate the safety, tolerability and pharmacokinetics of single~     and multiple-dose escalation of RSV604 administered intravenously in healthy subjects.~   "
239791|NCT00416429|"~     RATIONALE: Medroxyprogesterone may help shrink or slow the growth of kidney cancer.~     Interferon may interfere with the growth of tumor cells. Aldesleukin may stimulate white~     blood cells to kill tumor cells. It is not yet known whether giving medroxyprogesterone,~     interferon, or aldesleukin alone is more effective than giving interferon together with~     aldesleukin in treating kidney cancer.~      PURPOSE: This randomized phase III trial is studying medroxyprogesterone, interferon, or~     aldesleukin to see how well they work when given alone compared to interferon combined with~     aldesleukin in treating patients with metastatic kidney cancer.~   "
239792|NCT00416403|"~     RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the~     laboratory may help doctors learn how fluvastatin effects biomarkers related to breast~     cancer.~      PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in~     women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.~   "
239793|NCT00416390|"~     RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming,~     growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and~     tomato products, may keep cancer from forming or growing. Collecting and storing samples of~     blood from patients with cancer to study in the laboratory may help doctors learn more about~     changes that may occur in DNA and identify biomarkers related to cancer.~      PURPOSE: This randomized clinical trial is studying how well lycopene works in treating~     patients with prostate cancer or benign prostatic hyperplasia.~   "
239794|NCT00416377|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more cancer cells.~      PURPOSE: This clinical trial is studying how well radiation therapy or combination~     chemotherapy work in treating young patients with Hodgkin's lymphoma.~   "
239807|NCT00416208|"~     The purpose of this study is to evaluate the efficacy and safety of a consolidation therapy~     with bortezomib in patients with multiple myeloma aged 61 to 75.~   "
239808|NCT00416195|"~     This is a randomized, double-blind, placebo-controlled, parallel group study to determine the~     maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be~     divided into two groups of 24 patients each. One group will be patients who take concomitant~     inducing AEDs (anti-epileptic drugs) and the second group will be patients who do not take~     concomitant inducing AEDs. In each group, 18 patients will receive E2007 (dose escalating to~     a maximum of 12 mg per day) and six will receive placebo.~   "
239809|NCT00416182|"~     Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to~     determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo)~     in patients with cystic fibrosis who have recently undergone sinus surgery.~   "
241841|NCT00389051|"~     The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor~     effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell~     Non-Hodgkin's Lymphoma.~   "
239795|NCT00416364|"~     There are a variety of methods to repair inguinal hernias. Each has its advocate and may~     confer advantages to individual patients. Postoperative pain, convalescence, recurrence, and~     economics have all been evaluated however none in a randomized blinded fashion. Recently,~     investigators have attempted to address some of these concerns with new prosthetic materials.~     The preferred method of repair currently employs a tension free technique using mesh~     prosthesis. The approach as advocated by Lichtenstein involves reinforcing the floor of the~     inquinal canal with an onlay mesh. Newer approaches use a double layer mesh that reinforces~     the floor in a preperitoneal and onlay technique (Prolene Hernia System) while obliterating~     the internal inguinal ring or by the Mesh Plug repair (bioresorbable or permanent) which~     reinforces the inguinal floor with an onlay mesh while obliterating the internal inguinal~     ring. Currently no study has compared these techniques for ease of performance, postoperative~     pain, convalescence, quality of life, or cost in a randomized double blinded fashion. NMCP is~     uniquely qualified to compare these repairs prospectively and blinded to best assess the most~     cost effective approach which causes the least pain. A prospective double-blinded randomized~     trial comparing the Lichtenstein onlay mesh technique to Prolene Hernia Sytem (PHS), Mesh~     Plug Repair (MPR), or Gore Bioresorbable plug for postoperative pain, duration of~     convalescence, cost, impact on quality of life and ease of performance is proposed. Impact on~     quality of life will be assessed serially with the SF 12 which is a validated survey used~     with serial measures in the acute setting.~   "
239796|NCT00416351|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and~     to see how well it works in treating patients with T-cell or natural killer-cell lymphoma~     that has relapsed or not responded to previous treatment.~   "
239797|NCT00416338|"~     Peritoneal dialysis accounts for more than 70% of the dialysis modality in Hong Kong. Exit~     site infection (ESI) is one of the causes leading to peritoneal catheter removal. Appropriate~     exit-site care can prevent ESI. As the presence of a causative organism is essential in ESI,~     eliminating organism invasion may be useful in preventing ESI. In the present study, an exit~     site care method aiming at preventing organism invasion is developed to investigate its~     effectiveness in reducing ESI. It is also hoped the present study can help to develop an exit~     site care method that can reduce the frequency of exit site dressing so as to reduce the~     burden of patients and to improve their quality of life.~      We’ll recruit one hundred new chronic peritoneal dialysis patients into the study. The~     patients will be divided into two groups. One group of the patients will use film-dressing~     method (F) and the other group will use simple gauze dressing method (G). F group patients~     will have the exit site covered with a dressing film and keep it intact for 7 days after~     having the exit site cleaned with antiseptic solution. G group patients will clean the exit~     site with antiseptic solution and change the simple gauze dressing daily.~      The outcomes of the two groups will be compared. The outcome will be expressed in terms of~     exit site infection free period, peritonitis free period and exit site condition~     classification. Patient subjective quality of life will also be compared at first and twelfth~     month.~   "
239798|NCT00416325|"~     RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from~     forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may~     keep prostate cancer from forming in patients at high risk of developing prostate cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in~     preventing prostate cancer in patients who are at high risk of developing prostate cancer.~   "
239799|NCT00416312|"~     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab and yttrium Y~     90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them~     without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.~      PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I~     131 tositumomab or yttrium Y 90 ibritumomab tiuxetan works in treating patients with~     non-Hodgkin's lymphoma.~   "
239800|NCT00416299|"~     To evaluate the use of new cardiac biomarker for the prediction of in-hospital cardiovascular~     complications in elderly patients undergoing elective cardiac surgery.~   "
239801|NCT00416286|"~     The purpose of the study is to was to evaluate the anti bacterial efficacy of sustain-release~     Cetylpyridinium chloride varnish on orthodontic patients.~   "
239802|NCT00416273|"~     The purpose of this study is determination of the event-free survival with and without~     Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific~     therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of~     death.~   "
239803|NCT00416260|"~     In the past five years, there is a growing body of published evidence on the feasibility, and~     oxygenation and lung protection benefits of high frequency oscillation (HFO) in the acute~     respiratory distress syndrome (ARDS). The investigators have recently demonstrated the short~     term feasibility and additional benefits with respect to oxygenation of HFO combined with~     tracheal gas insufflation (TGI). In the present clinical trial, the investigators intend to~     test the hypothesis that HFO-TGI may result in improved respiratory physiology and clinical~     course compared to low tidal volume conventional mechanical ventilation in patients with~     severe ARDS.~   "
239804|NCT00416247|"~     This study is intended to investigate neurophysiological mechanisms of hypnosis using~     transcranial magnetic stimulation (TMS) and assessment of motor cortex excitability in~     healthy volunteers under hypnosis.~   "
239805|NCT00416234|"~     The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance~     with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach)~     is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD~     clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with~     combined cholelithiasis and choledocholithiasis.~   "
239806|NCT00416221|"~     Researchers at the University of California at San Diego (UCSD) are conducting a 12-week~     study to test the PACEPRO program. This program is designed to reduce depression by~     providing:~      Lexapro, an antidepressant medicine…Learn More Physical activity information and pedometer~     Mood management skills and a Mood Mastery Guide Personalized support from a Family Nurse~     Practitioner~   "
239810|NCT00416169|"~     The purpose of this study is to explore the safety and tolerability and the efficacy of~     galantamine treatment in subjects with Pick Complex/ Frontotemporal Dementia (PC/FTD). The~     safety and tolerability of galantamine therapy will be assessed over the entire treatment~     period (26 weeks). The 8 week withdrawal period will be used to confirm the safety of~     galantamine withdrawal in this subject group and it impact on any symptom improvement~     achieved during the first 18 weeks of galantamine treatment ( symptom improvement would be~     expected to stabilize or decline on withdrawal of an effective therapy).~      The primary efficacy objective is to explore the effect of galantamine on behavior as~     measured by the Frontal Behavioral Inventory during the randomized withdrawal period. In~     addition, for subjects with primary progressive aphasia (limited ability for languages), the~     effects of galantamine on language will be explored using the Aphasia Quotient of the Western~     Aphasia Battery, and for all subjects the Clinical Global Impressions will be used to explore~     global change.~   "
239811|NCT00416156|"~     To investigate whether weight reduction by life style modification for 12 weeks will improve~     circulating inflammatory markers, adipocytokines as well as gene expression of~     proinflammatory protein obtained from circulating monocytes from obese individuals.~   "
239812|NCT00416143|"~     sudden sensorineural hearing loss:~        -  idiopathic in most cases~        -  5-20/100,000 new cases annually in the U.S~        -  no establishes pathogenesis~        -  treated with oral steroids in most cases~        -  ~50% improvement in hearing levels~        -  bed rest - acceptable treatment, not well investigated~   "
239813|NCT00416130|"~     Purpose:~        -  evaluate the safety of Vorinostat.~        -  evaluate the effectiveness of Vorinostat in treating breast cancer~        -  evaluate how the study subject's body reacts to Vorinostat, how these reactions relate~          to the subject's genes, and whether protein changes in the subject blood may be used to~          predict how the subject's cancer will respond to Vorinostat~      We hypothesize that Vorinostat, as a novel class of anti-cancer agents, may induce response~     in patients with recurrent or metastatic breast cancer who have been previously treated with~     anthracyclines and taxanes. In addition, we hypothesize that serum Vorinostat levels may~     correlate with clinical response and toxicities, and that Vorinostat may induce unique~     protein changes in the plasma in responding patients, and that these proteins may in turn be~     used as predictive biomarkers for treatment response.~   "
239814|NCT00416117|"~     Mounting evidence does support the combined use of manual physical therapy (MPT)and exercise~     for patients with cervicogenic headache and mechanical neck pain. However, there is~     insufficient evidence to assess the effectiveness of MPT and exercise for patients with neck~     disorders with radicular symptoms. Our purpose for this study was to determine the~     effectiveness of a manual physical therapy and exercise program as compared to a minimal~     intervention approach in the treatment of patients with mechanical neck pain, with or without~     upper extremity symptoms.~   "
239815|NCT00416104|"~     The aim of this retrospective study is to find out if one or more of the following parameters~     has an impact on postcesarean section pain:age,ethnic origin, parity,body habitus, smoking,~     breastfeeding, education,newborn in intensive care unit, primary/repeated~     operation,elective/emergency operation,junior/senior surgeon,type of anesthesia during~     operation.~   "
239816|NCT00416091|"~     Tourette's disorder (TD) is a childhood-onset neuropsychiatric disorder, manifesting motor~     and vocal tics with increased likelihood of comorbid with attention-deficit/hyperactivity~     disorder (ADHD) and other psychiatric disorders. Literature documents the comorbid condition~     with ADHD predicts an increased functional deficit among individuals with ADHD. The~     information about neuropsychological functioning among individuals with TD adn/or ADHD is~     little in Asian population. This study aims to validate the diagnoses of TD, ADHD, and TD~     comorbid ADHD by symptomatology, neuropsychological measures, and social adjustment. This is~     a case-control study with a sample of 30 subjects with TD, 60 with ADHD, 30 with TD+ADHD, and~     60 controls aged from 6 to 18. All subjects will receive comprehensive assessment including~     standard psychiatric diagnostic interviews using (K-SADS-E), behavioral assessments (SNAP-IV,~     CPRS:R-S, CTRS:R-S, CBCL, YBOCS, YGTSS), social adjustment (SAICA, GCAS), parenting (PBI,~     APGAR) and neuropsychological assessment (CPT, CANTAB, WISC-III). We anticipate that this~     study will provide the primitive data to validate the TD and ADHD using neuropsychological~     and clinical measures.~   "
239817|NCT00416078|"~     This study is piloting an internet-based intervention to provide support for caregivers of VA~     patients with Alzheimer's disease or related memory difficulties (ADRD). Veterans with a~     clinical diagnosis of ADRD and their caregiver/relatives will be randomized to receive one of~     two interventions: (1) customary care (cc) and access to an intensive, interactive online~     education and support website intervention for 6 months, or (2) cc and monthly brief~     telephone calls with project staff for six month. It is hypothesized that participation in~     the intensive intervention will result in a reductions in patient problematic behavior and~     caregiver responses to it, reduced caregiver burden and depression, and improved medication~     adherence at the end of treatment, and more patients remaining at home through the 12 months~     post-randomization period..~   "
239818|NCT00416065|"~     The purpose of this research is to evaluate the presence, location and intensity of FDG~     uptake in the large arteries using the new technology of fused PET/CT imaging and to compare~     FDG uptake with the presence of arterial calcifications as seen on the simultaneously~     acquired CT, in order to determine if FDG was increases incalcified plaque or in a different~     location in the arterial wall. we will also evaluate the relationship between FDG~     localization and future cardiovascular events in out patient population~   "
239819|NCT00416052|"~     Accumulating evidence indicated that renal calcium stone formers often exhibit a low bone~     density. Therefore we want to test the hypothesis, that the mineral (calcium) metabolism is~     differently regulated in calcium stone formers with low as opposed to high bone density.~   "
239820|NCT00416039|"~     It is a randomized simple-blind monocentric study; the group A will receive oral morphine~     with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of~     this study is to show a more important pain decrease in the group taking midazolam versus~     placebo.~   "
239821|NCT00416026|"~     The purpose of the study was to test a telephone counseling intervention for patients after~     leaving the hospital for a heart attack to use medication, exercise, healthy eating and~     smoking cessation to prevent further heart attacks.~   "
239822|NCT00416013|"~     Beta Natriuretic Peptide (BNP) is regarded as the most sensitive test for congestive heart~     failure (CHF). BNP has also been found to be highly predictive of other conditions including~     pulmonary hypertension, pulmonary embolism and in the general population where mild increases~     are associated with stroke and heart attack. BNP is also weakly and variably correlated with~     renal function.~      We believe that each dialysis patient will have an ideal or dry BNP level which will~     accurately and reproducibly reflect their optimal fluid status. Secondary hypotheses are that~     baseline BNP and troponin, as well as changes in BNP and troponin during dialysis, will be~     highly predictive of mortality and adequacy of dialysis.~   "
239823|NCT00416000|"~     It has been estimated that 80% of deaths from abdominal aortic aneurysms results from~     rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal~     Aortic Aneurysm) patients with reports of improvements. Despite the use of EVAR, patients~     have developed complications with lung and kidney function. This study will investigate~     certain biochemical processes that will potentially reduce these complications. Knowledge~     gained from this study may also be used to further research in this field through larger~     studies.~   "
239824|NCT00415987|"~     The treatment assignment is based on the presence or absence of an HLA-identical sibling~     donor (Genetic Randomisation, NOT formal Randomisation). Patients with suitable HLA-identical~     sibling donors are offered a tandem transplant approach consisting of standard autografting~     nonmyeloablative radiotherapy and allografting. Patients without HLA-identical siblings are~     treated with standard double autologous transplantation as per Institutional guidelines or~     enrolled in other treatment programs approved by local IRBs.This is a multi-center study. The~     Division of Hematology of University of Torino at the S.G.B. Hospital, Torino, Italy, is the~     co-ordinating Center.~   "
239825|NCT00415974|"~     This 12-month randomized controlled trial, sponsored by NIH/NCI, aims to reduce BMI in obese~     adolescents (ages 11 -13) by intervening on physical activity and nutrition behaviors within~     primary care settings.~      PACE-PC is a theory-based stepped care program that enables pediatricians and primary care~     providers to intervene with obese adolescents to improve their anthropometric, metabolic,~     physiological, behavioral, and quality of life outcomes over a one-year period. The program~     integrates clinician counseling, health educator counseling, and phone and mail contact. It~     supports tailoring to the needs of obese adolescents and family members and promotes improved~     diet and physical activity behaviors, weight loss, and ultimately weight loss maintenance.~      Participants will be randomly assigned to the Enhanced Usual Care or the PACE-PC stepped care~     condition. The Enhanced Standard Care condition includes an initial visit and counseling by a~     physician, 3 visits with a health educator, and materials on how to improve weight related~     behaviors.~      The PACE-PC Stepped Care condition includes 3 steps (each lasting 4 months), with the first~     step being the most intensive:~      Step 1 includes: a physician visit, monthly health educator visits, biweekly phone~     counseling, and weekly dissemination of nutrition and physical activity information~      Step 2 includes: a health educator visits every other month, biweekly phone counseling, and~     weekly dissemination of nutrition and physical activity information~      Step 3 includes: monthly phone counseling and weekly dissemination of nutrition and physical~     activity information~      Participants randomized to the PACE-PC condition will be enrolled in Step 1 (the most~     intensive) for the first 4 months. Depending upon response at the end of Step 1, for the next~     4 months adolescents will be triaged to Step 2 (less intensive) or will repeat Step 1. At 8~     months, again based upon treatment response, triage will occur to either Step 3 (least~     intensive) or repetition of the previous step.~   "
239826|NCT00415961|"~     This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to~     the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in~     in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.~   "
239827|NCT00415948|"~     The purpose of the study is to procure blood samples from patients who present to the~     Emergency Department with suspected ACS (Acute Coronary Syndrome).~   "
239828|NCT00415935|"~     A comparison of outcome in children with JIA who are in remission on MTX, when MTX is then~     stopped for either 6 or 12 months~   "
239829|NCT00415922|"~     The purpose of this study is assess the safety and bioequivalence of a single oral dose of~     carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa~     combination plus a single oral dose of entacapone under fasting conditions in healthy~     volunteers.~   "
239830|NCT00415909|"~     Objectives:~        -  To determine the response rate and duration of response with combination of TALL-104~          cells and imatinib mesylate (IM) therapy in patients with chronic myelogenous leukemia~          in chronic phase, that have not achieved, or have lost, adequate response to IM.~        -  To determine the toxicity of the combination of TALL-104 cells and IM therapy in this~          patient population.~   "
239831|NCT00415896|"~     This study investigates how different degrees of muscular unloading during mechanical~     ventilation impact endurance of succeeding spontaneous breathing trials~   "
239832|NCT00415883|"~     The purpose of this study is to assess how the body changes the blood level of single dose of~     valsartan 160 mg tablet Japanese formulation and valsartan 160 mg tablet global formulation~     under fasting condition in healthy volunteers.~   "
239833|NCT00415870|"~     This is a NCI funded study which will develop and evaluate a cell phone application (mDIET)~     that can be used as an assessment and intervention tool to improve dietary behaviors and thus~     reduce weight in overweight and moderately obese (BMI 25-34.9) men and women ages 25-55.~   "
239834|NCT00415857|"~     The goal of this clinical research study is to find out if using the PR1 peptide vaccine~     (PR1) without PEG-Intron® (interferon) or in combination with interferon can reduce or~     eliminate disease in patients who have CML that is in cytogenetic remission after treatment~     with imatinib mesylate, but who still have small amounts of disease able to be noticed~     (detected). Researchers want to see if giving low doses of interferon together with PR1 may~     make the vaccine more effective. The safety of treatment in this study will also be studied.~   "
239835|NCT00415844|"~     The purpose of this study is to assess the safety and bioequivalence of a single oral dose of~     carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa~     combination plus a single oral dose of entacapone under fasting conditions in healthy~     volunteers.~   "
239836|NCT00415831|"~     The purpose of this study is to assess the safety and bioequivalence of a single oral dose of~     carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa~     combination plus a single oral dose of entacapone under fed conditions in healthy volunteers.~   "
239837|NCT00415818|"~     The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in~     comparison with chemotherapy alone in patients with advanced non small cell lung cancer.~   "
239838|NCT00415805|"~     This is an explorative small pilot study comparing two MRA contrast agents, one of which has~     been on the market for a few years and the other fairly new to the market. Since the study is~     explorative and designed to provide preliminary information for consideration for a future~     larger study, sample size is not based on statistical assumptions.~   "
239842|NCT00415753|"~     Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish~     Hospital setting. To test if it is possible to reduce the use of antibiotics and the length~     of stay in hospital, and the willingness of the clinicians to take this new marker under~     advisement in their choice of treatment.~      The study is a randomised, controlled intervention study. All adult patients admitted to the~     Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract~     infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion.~     Patients are randomised to have either PCT guided treatment or standard care, in which case~     the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will~     be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is~     discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT~     is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is~     allowed to overrule the treatment guidelines. The control group will receive antibiotics~     according to usual practice.~      The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint~     is the proportion of patients where the treating doctor chooses to disregard the guidelines.~   "
239843|NCT00415740|"~     The purpose of this study is to assess the safety and bioequivalence of a single oral dose of~     carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa~     combination plus a single oral dose of entacapone under fasting conditions in healthy~     volunteers.~   "
239844|NCT00415727|"~     The hypothesis is that in sickle cell anaemia, nocturnal oxyhaemoglobin desaturation, is~     associated with low processing speed index, and this morbidity can be reduced with overnight~     auto Continuous Positive Airways Pressure and/or oxygen supplementation.~   "
239845|NCT00415714|"~     The objective of this study is to determine the efficacy of a portable biofeedback device on~     improving sleep latency and other sleep variables such as nocturnal awake time and daytime~     functioning in persons with primary insomnia.~   "
239846|NCT00415701|"~     The purpose of this study is to evaluate the effect of a single dose of etomidate for~     patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB~     adrenocortical responsiveness, on requirements of hemodynamic support, and on use of~     intensive care resources.~   "
239847|NCT00415688|"~     Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary~     evidence suggests that low carbohydrate diets improve glycemic control when accompanied by~     weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate~     during weight loss, we compared two weight loss diets with different carbohydrate levels for~     the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.~   "
239848|NCT00415675|"~     Primary Objectives:~        -  To collect accurate and reliable respiration-induced anatomic structure motion data~          using four-dimensional (4-D) imaging technology.~        -  To analyze these data to study respiration-induced variations and patterns in variations~          of positions, shapes and volumes of tumors and normal anatomic structures in the thorax~          and abdomen over a breathing cycle, from one breathing cycle to the next, day-to-day and~          over the course of radiotherapy.~        -  To assess dosimetric and potential clinical consequences of respiratory motion in the~          current practice of radiotherapy through preclinical treatment simulation (treatment~          planning) studies.~        -  To quantify the potential consequences of explicitly accounting for respiration-induced~          motion on dose distributions and outcome (tumor control probabilities and normal tissue~          complication probabilities) through preclinical treatment simulation studies.~      Secondary Objectives:~        -  To investigate the feasibility of using patient training to regulate patient breathing~          and improve the quality of images and to stratify patients for their eligibility for~          respiratory-correlated imaging and radiotherapy and for the implementation of various~          strategies for mitigation of respiratory-induced motion.~        -  To assess the degree of correlation of the marker (or internal anatomic structure such~          as diaphragm) being tracked as surrogate of breathing with the motion of structures and~          the intra-fraction and inter-fraction reproducibility of such correlation.~        -  To quantify the effects of radiation therapy on the patterns of respiratory-induced~          motion of structures through preclinical treatment simulation studies.~        -  To compare various strategies for either accounting for or mitigating~          respiration-induced motion in the planning and delivery of radiation therapy.~   "
239849|NCT00415662|"~     In order to assess the effectiveness of biomagnetic therapy (PST) in the treatment of~     gonarthrosis, we conducted a randomized, double blind controlled clinical trial comparing one~     group of patients treated with PST and a second group of patients treated with conventional~     physical therapy.~   "
239850|NCT00415649|"~     The purpose of this study is to evaluate the safety and tolerability of and immune response~     to an HIV DNA vaccine followed by an adenoviral vector HIV vaccine in healthy African adults~     at risk for HIV infection.~   "
239851|NCT00415636|"~     The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for~     the treatment of cancer.~   "
239852|NCT00415623|"~     The changes in the trough systolic blood pressure from the baseline were assessed after 8~     weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg~   "
239853|NCT00415610|"~     The purpose of this trial is to evaluate the safety and effectiveness of lowering blood~     pressure using nicardipine in persons with acute hypertension associated with intracerebral~     hemorrhage.~   "
239854|NCT00415597|"~     Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered~     for up to 12 months.~   "
239855|NCT00415584|"~     Secondary hyperparathyroidism can persist following successful renal transplantation and can~     cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other~     problems. If the condition does not resolve, surgery is frequently required to remove the~     parathyroid glands, with all the inherent risks of surgery. Cinacalcet, a medicine used to~     treat secondary hyperparathyroidism in patients with kidney disease, may be effective in~     treating this condition in the renal transplant recipient. We will study the effect of~     cinacalcet on calcium, bone and renal function in a 6 month treatment protocol.~   "
239856|NCT00415571|"~     The objective of the study is to assess and compare the preliminary efficacy, safety and~     tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment~     of hypogonadal men with erectile dysfunction (ED) unresponsive to PDE5 inhibitors.~   "
239857|NCT00415558|"~     The purpose of this prospective, single-arm, un-blinded, multi-site clinical study is to~     assess the safety and efficacy of the Microwave Ablation System for the treatment of~     symptomatic paroxysmal atrial fibrillation (PAF) in the minimally invasive surgical (MIS)~     procedure in approximately 30 patients at 6 investigational sites in the United States.~   "
239858|NCT00415545|"~     Heart failure patients living in rural areas usually do not have adequate access to formal~     heart failure management programs. This study will compare two versions of an educational~     intervention aimed at improving self-care management techniques among individuals with heart~     failure who are living in rural areas.~   "
239859|NCT00415532|"~     This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label,~     52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia~     Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must~     complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible~     after the initiation of romiplostim. After the completion or discontinuation of the study~     treatment period, any participant who does not transfer in to another romiplostim study will~     complete a 6-month Safety Follow-up period.~   "
239860|NCT00415519|"~     The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via~     intravenous drip once a day in patients with ALS whose severity is classified as grade III,~     based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24~     weeks administration in double-blind, placebo-controlled manner. And in addition, this study~     will be performed to examine the safety of MCI-186 to ALS patients who met severity~     classification III.~   "
239861|NCT00415506|"~     The purpose of this study is to assess the safety and tolerability of Rituximab in refractory~     scleritis and non-infectious orbital inflammation.~   "
239862|NCT00415493|"~     This study seeks to compare patients with vasomotor rhinitis (perennial nonallergic~     rhinitis, idiopathic rhinitis) with normal controls with respect to their nasal~     physiologic reactivity to cold air challenge. Ten vasomotor rhinitis (VMR) patients with~     nasal symptoms triggered predominantly by cold air, four VMR patients with symptoms triggered~     predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be~     studied.~   "
239863|NCT00415467|"~     The goals of this study are to evaluate each of the following items:~        1. Time to recurrence in patients receiving brachytherapy with the GliaSite RTS~        2. Overall survival (OS) in patients with malignant brain tumors who are undergoing~          surgical resection and brachytherapy treatment with the GliaSite® Radiation Therapy~          System (RTS).~        3. Incidence of serious adverse events in patients treated with GliaSite RTS~   "
239864|NCT00415454|"~     The primary purpose of this phase I study is to determine the safety of combining~     replication-competent adenovirus-mediated suicide gene therapy with chemoradiotherapy in~     patients with non-metastatic pancreatic cancer.~   "
239865|NCT00415441|"~     The purpose of this study is to investigate whether a physiotherapy program reduces pain and~     improves disability and quality-of-life in people with chronic shoulder pain.~      The main study hypotheses are that (i) A 10-week physiotherapy treatment will result in~     significantly greater reductions in pain and disability than placebo treatment in individuals~     with chronic shoulder pain (ii) Improvements in pain and disability following a 10-week~     physiotherapy treatment will be maintained at a 3-month follow-up.~   "
239866|NCT00415428|"~     The overall objective is to increase the adherence to national guidelines for patients with~     established CVD and/or Type 2 diabetes by means of repeated post-graduate educational~     meetings and regular evaluation of the optimisation initiatives, demonstrated by improvement~     of goal attainment in general practice.~   "
239867|NCT00415415|"~     Coronary heart disease (CHD) is the leading cause of deaths that are related to~     cardiovascular disease in the United States, and Mississippi's CHD mortality rate is the~     highest in the nation. This study will examine data from the Jackson Heart Study to determine~     the effect of socioeconomic status and psychosocial factors on CHD risk in African Americans~     in Mississippi.~   "
239868|NCT00415402|"~     The purpose of this study is to determine whether a weekly supplement of vitamin D to low~     birth weight term infants will reduce their mortality and hospital admissions and improve~     their immunity.~   "
239869|NCT00415389|"~     The purposes of this study are to determine the effectiveness of an interactive stroke~     educational program compared to standard educational materials and usual care, to increase~     stroke knowledge, and to improve emergency room arrival times upon onset of stroke symptoms.~   "
239870|NCT00415376|"~     RATIONALE: Anticonvulsant drugs, such as levetiracetam, may help control seizures caused by~     brain metastases.~      PURPOSE: This clinical trial is studying the side effects and how well levetiracetam works in~     treating patients with seizures caused by brain metastases.~   "
239871|NCT00415363|"~     This study is a multinational study to compare enzastaurin versus placebo in the treatment of~     patients with brain metastases of lung cancer. Approximately 108 patients will be randomly~     assigned to receive either enzastaurin or placebo after having completed whole brain~     radiotherapy.~   "
239872|NCT00415350|"~     1. SUMMARY~      Rationale: Patients with bronchiectasis often experience lower respiratory tract infections~     with progression of symptoms and decline in quality of life. Macrolides, as has been shown in~     panbronchiolitis and cystic fibrosis, may break or weaken the link between infection and~     inflammation resulting in an improvement of symptoms. Also the number of exacerbations may~     lowered.~      Objective: A reduction in number of infective exacerbations and improvement in lung function~     by AZT treatment are the primary objectives. Secondary objectives that will be evaluated are:~     symptoms score, quality of life, inflammatory parameters, bacterial colonisation, and adverse~     events.~      Study design: Randomised double blind multicenter study in the Netherlands. Patients will be~     stratified for colonisation with P.aeruginosa.~      Study population: Patients with bronchiectasis demonstrated by high-resolution computed~     tomography (HR-CT) scan or bronchography.~      Intervention: Patients receive Azithromycin 250mg(p.o.) once daily or placebo.~      Main study parameters/endpoints: Reduction in number exacerbations, defined as increase~     symptoms such as dyspnoea, coughing, and sputum production for which a course of prednisolone~     and/or antibiotic is needed. Change in lung function parameters (forced expiratory volume in~     1 second [FEV1], forced vital capacity [FVC]) measured by spirometry is the other primary~     endpoint.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The risk of participating in this study is low. Laboratory, radiographic~     examinations, and pulmonary function tests are commonly used as diagnostic procedures during~     outpatients visits and during exacerbations. Adverse effects in maintenance treatment with~     AZT are usually mild and mainly gastrointestinal. Sometimes rash and abnormal liver function~     tests are observed. A better quality of life will probably be the beneficial effect of long~     term treatment with AZT. This will be achieved by a reduction in respiratory and~     non-respiratory symptoms and number of exacerbations.~   "
239873|NCT00415337|"~     1. Endobronchial ultrasonography (EBUS) is useful in localizing peripheral lung lesions.~          The EBUS, further combined with the guide sheath (GS) technique, has been reported to~          increase the yield of transbronchial biopsy. However, there are no reports comparing the~          GS technique and the traditional EBUS technique in diagnosing the peripheral lung tumor.~        2. Previous reports have revealed that several characteristic echoic patterns correlate~          well with the histopathological findings of benign and malignant lesions. Therefore,~          EBUS may also be useful in the differential diagnosis of malignant lesions of the lung.~   "
241842|NCT00389038|"~     The purpose of this trial is to evaluate the efficacy of combined behavioral and~     pharmacological treatment on chronic daily headache in children ages 10 to 17.~   "
239874|NCT00415324|"~     This trial is studying the side effects and best dose of eribulin mesylate and cisplatin in~     treating patients with advanced solid tumors.Drugs used in chemotherapy, such as eribulin~     mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more tumor cells.~   "
239875|NCT00415311|"~     This is a multicenter, open-label, randomized, Phase 1B study evaluating liver transplant~     recipients receiving rhMBL (2 cohorts) or without rhMBL (1 cohort).~   "
239876|NCT00415298|"~     RATIONALE: Drugs used in chemotherapy, such as AP5346 and oxaliplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~      PURPOSE: This randomized clinical trial is studying the dose of AP5346 to see how well it~     works compared with the dose of oxaliplatin in treating patients with metastatic and/or~     unresectable recurrent head and neck cancer.~   "
239877|NCT00415285|"~     The purpose of this study is to identify new chemotherapy treatment regimens with better~     response rates and to find out if the combination of docetaxel and capecitabine can shrink~     the size of breast tumors and preserve the breast.~   "
239878|NCT00415272|"~     Our study aims to investigate the benefits of an outpatient pulmonary rehabilitation program~     in a population of subjects with fibrotic interstitial lung disease. Our hypothesis is that~     pulmonary rehabilitation will lead to improvements in quality of life, breathlessness,~     exercise capacity and pulmonary function in this patient population.~   "
239879|NCT00415259|"~     It is hypothesised that laterally wedged insoles will result in reduced knee pain and~     cartilage volume loss after 12 months of wear, compared to control insoles. People with~     symptomatic knee osteoarthritis will be recruited from the community and randomised to wear~     either laterally wedged insoles or control insoles for 12 months. Patients will be assessed~     at baseline and at 12 months.~   "
239880|NCT00415246|"~     To identify the proportion of patients remaining medically castrated (testosterone level < 50~     ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR)~     formulation of triptorelin.~   "
239881|NCT00415233|"~     RATIONALE: Radioactive iodine uses radiation to kill tumor cells. Giving iodine I 131 with or~     without thyroid-stimulating hormone after surgery may kill any tumor cells that remain after~     surgery. It is not yet known which dose of iodine I 131 is more effective when given with or~     without thyroid-stimulating hormone in treating thyroid cancer.~      PURPOSE: This randomized phase III trial is studying two different doses of iodine I 131 to~     compare how well they work when given with or without thyroid-stimulating hormone in treating~     patients who have undergone surgery for thyroid cancer.~   "
239882|NCT00415220|"~     The purpose of this study was to compare standardized chiropractic treatment (spinal~     manipulation) to back surgery (microdiscectomy) for patients with sciatica secondary to~     lumbar herniated disc refractory to medical management.~   "
239883|NCT00415207|"~     This study will try to determine whether or not certain genes are responsible for the huge~     variation in toxicity and effect observed between patients treated with paclitaxel~     (chemotherapeutic drug). Specifically we will study this retrospectively in patients who~     participated in clinical trials that are now closed. All patients had ovarian cancer and~     received paclitaxel/carboplatin chemotherapy after primary surgery.~   "
239884|NCT00415194|"~     This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in~     head and neck cancer patients.~   "
239885|NCT00415181|"~     This study will try to determine whether or not certain genes are responsible for the huge~     variation in toxicity and effect observed between patients treated with paclitaxel~     (chemotherapeutic drug). Specifically we will study this in patients with ovarian cancer who~     receive paclitaxel/carboplatin chemotherapy after primary surgery.~   "
239886|NCT00415168|"~     Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the~     response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not~     amenable to curative surgery, or recurrence after prior surgery, who have had no prior~     chemotherapy. It was planned to enroll approximately 50 patients who qualified for tumor~     response population.~   "
239887|NCT00415155|"~     The primary objective of this study is to estimate the time to progressive disease for~     patients with advanced hepatocellular cancer who receive LY2181308.~   "
239888|NCT00415142|"~     The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major~     Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on~     disability and quality of life in patients with major depressive disorder.To evaluate safety~     and tolerability of 24 weeks of additional treatment in patients completing the initial~     8-week treatment period.~   "
239889|NCT00415129|"~     Based on the results from a previous formulation/dosage ranging trial, this phase II~     multicenter, open trial was designed to determine the safety and immunogenicity of two~     vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in~     adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines~     Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12~     months will also be evaluated.~   "
239890|NCT00415116|"~     RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the~     tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving lenalidomide together with docetaxel and carboplatin may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when~     given together with docetaxel and carboplatin in treating patients with advanced solid~     tumors.~   "
239891|NCT00415103|"~     The purpose of this trial is to determinate the security, tolerability and efficacy of~     aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis~     induced by chemotherapy in patients treated with haematopoietic progenitors transplant.~   "
239892|NCT00415090|"~     The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1~     < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.~   "
239893|NCT00415077|"~     The purpose of this study is to assess whether there is a significant difference in visual~     outcomes or corneal haze after surface ablation for moderate and high myopia in active duty~     service members treated with PRK, Mitomycin-C (MMC) PRK and LASEK.~   "
239894|NCT00415064|"~     This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for~     patients with relapsed or refractory multiple myeloma. The current protocol will enroll~     patients with relapsed or refractory multiple myeloma requiring second or third line therapy.~     Six patients each will be treated with at one of 4 dose levels in a phase 1 study. All~     patients will receive perifosine, lenalidomide and dexamethasone of each 28 day cycle. The~     doses of perifosine and lenalidomide will be varied in each group. The dose of dexamethasone~     will remain constant.~   "
239895|NCT00415051|"~     This study is to determine if a vaccine for Rift Valley Fever (RVF) is safe to give to~     humans. The study will examine how well the vaccine (RVF MP-12) stimulates the body's immune~     response (which fights off infection) and if the vaccine is stable or if the virus used to~     make the vaccine changes into a different form once injected into the body. Twenty healthy~     volunteers (18-50 years old) will be vaccinated with a single dose of undiluted RVF MP-12,~     injected into a muscle.~   "
239896|NCT00415038|"~     The purpose of this study is to verify the efficacy of Rostafuroxin in the treatment of~     essential hypertension and to determine the best effective dose to be administered in the~     general hypertensive population and in a subset of this population in which genetic patterns~     could be involved in the etiology of essential hypertension.~   "
239897|NCT00415025|"~     RATIONALE: Tests that measure how much saliva is made, hearing, swallowing, voice function,~     and quality of life may improve the ability to plan treatment for patients with advanced head~     and neck cancer and may help doctors find better ways to treat the cancer.~      PURPOSE: This clinical trial is studying the side effects of high-dose intensity-modulated~     radiation therapy in treating patients with advanced head and neck cancer.~   "
239898|NCT00414999|"~     The formation of new blood vessels (angiogenesis), blood vessel leakage, and inflammation~     contribute to the progression of the eye disease, age-related macular degeneration (AMD),~     which is the leading cause of irreversible, severe loss of vision in people 55 years of age~     and older in the developed world. TG100801 is a new drug that inhibits ocular angiogenesis,~     vascular leak, and inflammation in laboratory studies, and may have great utility in the~     treatment of diseases such as AMD.~      The purpose of this study is to assess the safety, ocular tolerability, and blood~     pharmacokinetics of TG100801 at escalating doses in healthy volunteers.~   "
239899|NCT00414986|"~     The study will randomize 54 primary care practices to two intervention and a comparison~     groups. Both interventions will involve an on-site Improvement Facilitator who will assist~     the practice in forming an Improvement Team, using rapid-cycle tests of change, and~     implementing chronic care office systems for type 2 diabetes and depression. One intervention~     is based on complexity science and the other is a traditional QI intervention.~   "
239900|NCT00414973|"~     The purpose of this study is to compare the effect of injectable teriparatide to intranasal~     salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients~     with established osteoporosis~   "
239901|NCT00414960|"~     To compare the difference of a marker of cellular proliferation in all bronchial biopsy~     specimens of former smokers stratified by lung cancer risk, collected before and after~     treatment per patient between the enzastaurin and placebo groups.~   "
239902|NCT00414947|"~     This study will evaluate the bioequivalence as well as rate and extent of absorption of~     vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported~     vildagliptin tablet in Chinese healthy volunteers.~      This trial is not recruiting patients in the United States,~   "
239903|NCT00414934|"~     18F ion is a positron emitting bone radiopharmaceuticals. The skeletal uptake of 18F relies~     on the exchange of hydroxyl ions in the hydroxyapatit crystal which is an indicator of bone~     metabolic activity (8). It has good soft tissue clearance and high affinity of to the bone~     matrix. It is able to perform a highly sensitive whole-body screening for bone metastases~     using a high resolution PET scanner. Therefore, we conduct a prospective study to evaluate~     the accuracy and clinical value of 18F PET in staging bone metastases by~        1. Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy;~        2. Determining the clinical impact of PET results on subsequent patient management.~   "
239904|NCT00414921|"~     The purpose of this study is to evaluate the safety and efficacy of two~     medications——clonidine and methylphenidate——alone or in combination to treat attention~     deficit hyperactivity disorder in children ages 4 through 6.~   "
239905|NCT00414908|"~     This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen~     absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a~     run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind~     period and a 6-month Open-Label Follow-up.~   "
239906|NCT00414895|"~     The goal of this study is to detect AR and CR in the transplanted heart by quantitative~     assessment of myocardial blood flow and its constituents by myocardial contrast~     echocardiography (MCE). Further we investigate the collateral circulation in these patients.~   "
239907|NCT00414882|"~     The purpose of the study is to see if one plan for identifying and treating tuberculosis (TB)~     works better than another in reducing new cases of TB. The first plan is the DOTS program,~     which provides free TB treatment to people seeking it. The second plan provides free TB~     treatment to people seeking it and involves program staff going door-to-door in communities~     to identify new cases of TB, DOTS plus active case-finding program (ACF). Researchers believe~     that by detecting TB cases earlier and supervising treatment it will help to prevent~     spreading and decrease TB in these areas. The study population will be 200,000 people in 6~     communities of Santa Cruz and 14 communities of Northeast Rio de Janeiro, Brazil, receiving~     DOTS or DOTS plus ACF. Individuals in the DOTS plus ACF part of the study will be interviewed~     2-4 times during a 9 month period. Patients with symptoms will provide a sputum specimen.~     Patients identified as having TB will begin treatment and be observed for 6.~   "
239923|NCT00414648|"~     Lymphangioleiomyomatosis (LAM) is a rare lung disease that is caused by genetic mutations. It~     results in the uncontrolled growth and proliferation of an unusual type of smooth muscle~     cell. These cells invade lung tissue, including the airways, blood vessels, and lymph~     vessels, and restrict the flow of air, blood, and lymph, respectively. Respiratory failure,~     lung collapse (pneumothorax), and pleural effusions (chylothorax) are hallmarks of the~     disease. This study will evaluate the safety and effectiveness of sirolimus, an~     immunosuppressive medication, in stabilizing or improving lung function in people with LAM.~   "
239908|NCT00414869|"~     Chronic liver diseases are often characterized by portal hypertension, a major complication~     involving haemodynamic changes due to increased intrahepatic vascular resistance. It has~     become well established that nitric oxide (NO) plays a crucial role in the haemodynamic~     abnormalities that develop in chronic portal hypertension.~      NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the~     defective liver NO production in cirrhosis.~      This study intends to demonstrate the desired therapeutic activity (reduction in portal~     pressure) in a small number of target patients, to assess the safety and tolerability after~     repeated oral administrations of NCX-1000, and to get preliminary pharmacokinetic data in~     this population.~   "
239909|NCT00414856|"~     This study will assess the safety and tolerability of oral single dose applications of AFQ056~     in GERD patients.~   "
239910|NCT00414843|"~     The purpose of the study is to establish a repository of human bile as a resource for studies~     evaluating molecular predictors of biliary cancer risk.~   "
239911|NCT00414830|"~     The purpose of this study is to determine if prevention of further fractures is possible~     through systematic evaluation for osteoporosis in patients with recent hip fracture~   "
239912|NCT00414817|"~     Inhaled corticosteroids (ICS) are often prescribed as a treatment for asthma. However, many~     individuals who take these medications do not adhere to their prescribed treatment regimen.~     The purpose of this study is to evaluate the effectiveness of a telephone-based program at~     improving medication adherence among individuals with asthma.~   "
239913|NCT00414804|"~     The primary objective of this study is to compare the efficacy of SCS using the Precision~     implantable neurostimulation device and conventional medical treatment (nerve blocks +~     physical therapy) in subjects with recently-diagnosed Complex Regional Pain Syndrome (CRPS)~     after some more conservative treatments have failed. There are significant numbers of~     patients with CRPS in whom conventional treatment is ineffective and SCS is used only as a~     last resort. If SCS is effective earlier in the treatment continuum, it would provide a much~     needed treatment alternative and increase awareness of the utility of SCS for this~     indication. It is also possible that early intervention with SCS may limit disease~     progression.~   "
239914|NCT00414778|"~     The purpose of this study is to evaluate safety and pharmacokinetics of a single and multiple~     dose of LHT344 in 12 Chinese healthy subjects.~      This study is not recruiting subjects in the United States.~   "
239915|NCT00414765|"~     This study will evaluate the pharmacokinetics of aldesleukin in patients with metastatic~     renal cell cancer and metastatic melanoma~   "
239916|NCT00414752|"~     The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine~     compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in~     healthy smokers. This study will also assess how the body interacts with AFQ056.~   "
239917|NCT00414739|"~     The study analysis the influence of benzalkonium chloride on the density of antigen~     presenting Langerhans cells. This is achieved in a double blind randomized study using~     in-vivo confocal microscopy to identify and quantify Langerhans cells of the human cornea in~     its central and peripheral part. This study design is based on observations with raised~     Langerhans cell density after the application of benzalkonium chloride containing eye drops~     in glaucoma patients.~   "
239918|NCT00414726|"~     The purpose of this study is to compare the safety and efficacy of treating individuals with~     acute ischemic stroke with normobaric oxygen therapy (NBO, given within 9 hours of symptom~     onset), to standard medical treatment.~   "
239919|NCT00414713|"~     Recently it has been suggested that a restrictive transfusion of units of Red Cells (URC) may~     improve the outcome of ICU patients with anemia. Furthermore, it has been suggested that the~     transfusion of URC may be deleterious for the hemostatic process of bleeding lesions, which~     suggest that a restrictive transfusion may be valuable in patients which gastrointestinal~     bleeding. Transfusion of URC may also increase portal pressure which may be detrimental to~     control acute portal hypertensive bleeding.~      The aim of the present study is to assess whether a restrictive transfusions may improve the~     outcome of patients with acute nonvariceal gastrointestinal bleeding, and also whether such a~     restrictive strategy may improve the outcome of bleeding episodes related with portal~     hypertension.~      The study will be carried out with a prospective, randomized and controlled design comparing~     the restrictive transfusion strategy with the usual nonrestrictive transfusional strategy.~     Overall 860 patients will be included; 430 in each group.~      The main outcome measure will be survival. All deaths occurred within the 30 days after~     admission, will be considered. Secondary outcomes will include rebleeding and complications~     related to treatment, and related to the bleeding episode itself. Portal pressure will be~     measured to assess the influence of the transfusions strategy on fluctuations of this~     parameter, and the relationship with the clinical course of bleeding episode.~      The study will be performed at the Bleeding Unit of our hospital during a period of 3 years.~   "
239920|NCT00414700|"~     This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect®~     in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of~     microfracture (MF) in the repair of symptomatic cartilage lesions of the knee. Eligible~     patients attended two screening visits and were booked for arthroscopy approximately 2 weeks~     later. At that time, patients were randomized to either ACI with ChondroCelect® or to MF, a~     procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar~     tissue. Patients randomized to MF had the procedure performed at the time of their~     arthroscopy; those randomized to ACI with ChondroCelect® had their cells harvested during the~     arthroscopy and then returned to the clinic approximately 4 weeks later for an open knee~     procedure, during which the ACI procedure using ChondroCelect® was performed. Patients~     subsequently followed the same rehabilitation program and had follow-up assessments up to 12~     months post-surgery. The 12-month visit was the end-of-study visit for the TIG/ACT/01/2000~     protocol. Subject to satisfying the eligibility criteria, patients who had participated in~     the initial 12 month trial could enter the extension trial. The 12-month visit for the~     initial study was the baseline visit for the extension study. During the extension study,~     patients have follow-up assessments up to 60 months post-surgery.~   "
239921|NCT00414687|"~     The purpose of this study is to determine whether the study drug is effective in the~     long-term treatment of primary or secondary pulmonary hypertension~   "
241843|NCT00389025|"~     To assess the effects of olopatadine of the release of mast cell histamine~   "
239928|NCT00414583|"~     More than one million people in Europe suffer from a stroke every day. Normally older people~     have a stroke, but also a significant number of younger people between 18 and 55 years.~     Usually, these cannot be explained by the classical risk factors such as diabetes, overweight~     and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke~     patients the cause could have been an undiagnosed genetic disease, the so called Fabry~     disease. The purpose of this study is to determine in a large number of young stroke~     patients, how many strokes were caused by Fabry Disease.~   "
239929|NCT00414570|"~     The objective of this pilot study are (i) to compare response to chemotherapy, time to~     disease progression and overall survival in patients with pancreatic cancer who will be~     treated with gemcitabine who demonstrate 18F-FLT uptake to those patients who do not~     demonstrate 18F-FLT uptake; (ii) to correlate 18F-FLT uptake with hENT1 expression with~     biopsy samples where available; (iii)to determine the presence or absence of uptake, the~     relative uptake score (RUS) and tumor to background ratios of 18F-FLT in patients with known~     carcinoma of the pancreas and assess this uptake in relation to time to disease progression;~     and (iv) to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre.~   "
239930|NCT00414557|"~     To investigate the effects of quadriceps strengthening on the adductor moment in individuals~     with medial knee OA and whether quadriceps strengthening has a different effect on the~     adductor moment in individuals with and without knee malalignment~   "
239931|NCT00414544|"~     This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of~     CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as~     nasolabial folds (i.e., smile lines).~   "
239932|NCT00414531|"~     The primary objective of the study is to investigate the ratios of p-hydroxyatorvastatin to~     atorvastatin in patients receiving atorvastatin treatment, who experience muscle adverse~     events, to elucidate whether differences in this ratio might have a positive or negative~     predictive value in diagnosing atorvastatin muscle toxicity.~   "
239933|NCT00414518|"~     The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug~     regimen followed by treatment interruption in people recently infected with HIV. This study~     will also compare the effects of a treatment regimen including treatment interruption with a~     treatment plan based on clinical indicators.~   "
239934|NCT00414505|"~     The purpose of this study is to determine whether intradermal acupuncture is effective and~     safe in the treatment of obesity.~   "
239935|NCT00414492|"~     Systemic chemotherapy for metastatic colon cancer is often used in the neoadjuvant setting~     for patients undergoing liver resection. This treatment is given either to keep the tumor at~     bay or reduce its size before the time of resection. While many metastatic tumors might~     appear to respond well and even radiographically disappear following neoadjuvant therapy, it~     is unclear whether grossly or radiographically negative areas of previous disease are~     microscopically free of tumor cells. As such, when possible, resection boarders typically~     follow 1 cm margins from the tumor size prior to neoadjuvant therapy. These margins might be~     necessary to encompass all histologically present disease or they might be unnecessarily~     large, serving only to increase the mortality and morbidity of the operation. This study~     begins to address this question by a histological examination of the pattern of cell death in~     areas of metastases removed after neoadjuvant therapy. Furthermore, clinical cases in which~     neoadjuvant therapy allowed for resection of previously unresectable cancer will be examined~     to determine whether there is an increased rate of recurrence despite negative resection~     boundaries in these cases.~   "
239936|NCT00414479|"~     The purpose of this study is to determine the extend and the nature of anemia in school~     children and the correlation between anemia and schistosomiasis infections, malaria~     infections and/or malnutrition (iron deficiency).~   "
239937|NCT00414466|"~     The purpose of this study is to determine the safety and minimum effective dose of~     intraspinal gabapentin when delivered through an implanted drug infusion system.~   "
239938|NCT00414453|"~     This study will determine whether treatment with an extended-release opioid or topical~     lidocaine is effective in relieving distal symmetric lower extremity burning pain associated~     with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will~     have important implications for understanding this chronic pain syndrome, which is widely~     assumed to be caused by central nervous system pathology.~   "
239939|NCT00414440|"~     This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney~     expansion as well as worsening of renal function in patients with ADPKD and whether the~     application of 5 mg/day everolimus as monotherapy is safe and well tolerated.~   "
239940|NCT00414427|"~     The primary purposes of this study are the following:~        1. To evaluate whether the presence of inflammatory knee osteoarthritis as determined by~          ultrasonography can be used as a clinical predictor of patient response to~          intra-articular corticosteroids.~        2. To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with~          the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical~          design.~        3. To evaluate whether lower extremity strength is improved with intraarticular~          corticosteroid injection.~      The investigators hypothesize that patients with signs of inflammation by ultrasonography~     such as synovitis and effusion will respond better to intraarticular corticosteroid~     injection.~   "
239941|NCT00414414|"~     The purpose of this study is to determine if 30-day survival will be improved with addition~     of prednisone to standard tuberculosis (TB) therapy.~   "
239942|NCT00414401|"~     Although beta-blockers are known to prolong survival for patients with reduced left~     ventricular ejection fraction, their use in the community and the VA is suboptimal.~   "
239943|NCT00414388|"~     The primary objective of this study is to evaluate the safety of combining Sorafenib and~     chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.~   "
239944|NCT00414375|"~     The objective of this study is to scientifically evaluate two different operative strategies~     for perforated appendicitis with abscess.~      The hypothesis is that the increased difficulty of early operation is balanced by the immense~     patient investment with delayed operation.~   "
239974|NCT00413985|"~     The purpose of this study is to determine whether low birth weight (LBW) infants fed human~     milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks~     after hospital discharge will have better growth and neurodevelopment than infants fed HM~     alone.~   "
239945|NCT00414362|"~     The information collected will optimize the management of patients with urinary tract~     infections with secondary bacteremia, primarily with gram negative bacteria especially~     Escherichia coli. The current IDSA guideline endorses the use of fluoroquinolones and~     trimethoprim-sulfamethoxazole as the first line agents. However, over use of this empiric~     regimen could result in in appropriate treatment of bacteremia.~   "
239946|NCT00414349|"~     The purpose of this study is to evaluate lidocaine as topical treatment for peripheral~     neuropathic pain (as stand-alone treatment and in combination with systemic treatment)~   "
239947|NCT00414336|"~     This study will evaluate the safety of an experimental vaccine can protect people from~     malaria and study its effects. Malaria, which affects many people in Mali and other countries~     in Africa, is caused by germs spread by mosquito bites. In Mali, the disease is the leading~     cause of death. Researchers at the Malaria Research and Training Center at the University of~     Bamako are working with NIH to develop an experimental vaccine against the disease. The~     vaccine, called AMA1-C1Alhydrogel (or AMA1-C1), contains a small part of the malaria-causing~     germ. CPG-7909 is a product to improve the body's reactions to vaccines.~      Patients ages 18 to 45 who are in good health, who live in Don gu bougou, Mali, and plan to~     stay there for the study duration, and who are not pregnant or breast feeding may be eligible~     for this study. There will be 24 participants.~      At an initial evaluation of 2 to 3 hours, patients will have a physical examination and~     undergo blood and urine tests regarding the blood, kidneys, and liver. During the study,~     patients will receive two injections of one of the two experimental malaria vaccines.~     Injections of the same vaccine each time, 4 weeks apart, are given in an arm muscle. Patients~     will receive either AMA1-C1 or AMA1-C1 with CPG-7909 but will not know which of the vaccines~     they receive until the study's end. After each injection, patients will stay in the clinic~     for 30 minutes for observation. They will return after 1, 2, 3, 7, and 14 days to be examined~     and report how they are feeling. Blood and urine samples will be collected at some visits.~     Each clinic visit takes 1 to 2 hours. If for some reason a patient receives only one~     injection, he or she will be asked to return to the clinic for routine visits until the~     study's end. After the first 2 months, patients will return to the clinic once a month for 30~     weeks. In that period, 12 blood samples will be taken. Researchers want to be sure that the~     vaccine is not harmful as well as to measure the vaccine's effects.~      Risks in this study include pain, swelling, and redness at the injection site; fever; and~     gastrointestinal problems. Some people have had a temporary decrease in white blood cells~     after receiving the vaccine. There is a small chance of a severe allergic reaction. However,~     researchers will closely watch patients immediately after each injection and will give~     treatment if a serious reaction occurs.~      Participants will receive 75 kilos of rice and 75 kilos of millet (165 lb. of ...~   "
239948|NCT00414323|"~     The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the~     transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine~     (NE), across cells in blood and cerebrospinal fluid.~   "
239949|NCT00414310|"~     The goal of this clinical research study is to find out if decitabine, given with or without~     valproic acid, can help to control AML or MDS. The safety of both treatments will also be~     studied.~   "
239950|NCT00414297|"~     The purpose of this study in humans with stable coronary artery disease (CAD) treatable by~     percutaneous coronary intervention (PCI) is to evaluate the efficacy of External~     Counterpulsation (ECP) with regard to the promotion of coronary collateral growth.~   "
239951|NCT00414284|"~     This study will look to see if increasing the standard dose of Kaletra is tolerated and if it~     will lower viral loads to undetectable levels. This study will also look at the~     pharmacokinetic data (amount of Kaletra in blood at different times).~   "
239952|NCT00414271|"~     Thymidylate Synthase (TS) is a key enzyme in the synthesis of DNA and the target enzyme~     inhibited by 5-fluorouracil. TS level in the tumour cells has been reported as predictive to~     response to 5-FU and a prognostic factor in colorectal and gastric cancer patients. We plan~     to study TS by IHC in the paraffin blocks of tumour tissue.~      A combined comparative genomic hybridization (CGH) and expression microarray analysis of~     gastric cancer specimens before and after neoadjuvant chemotherapy. CGH will be performed~     using standard technique routinely done in Dr Patrick Tan's laboratory at the National Cancer~     Centre, which determines the gain or loss of DNA copies of each chromosome. Total RNA will be~     extracted from at least one biopsy sample which contains at least 50% cancer cells by~     homogenization of the tumour tissue and tri-sol method. 5 ug of RNA were amplized and~     hybridized with the C-DNA microarrays of 18K targets.~      Primary Objective~      1. Feasibility and safety of pre-operative chemotherapy in locally advanced gastric cancer.~      Secondary Objective~        1. Complete clinical and pathological response rates to pre-operative chemotherapy in~          locally advanced gastric cancer~        2. Complete resection rate.~        3. Time to recurrence, disease free and overall survival~        4. Correlation of clinical outcome with RUNX-3 methylation status and Thymidylate~          synthetase in the tumor tissue.~        5. Correlation of CGH and gene expression profile and their changes after chemotherapy with~          clinical outcome.~           Patients may be included in the study only if they meet all of the following criteria:~           Age at least 18 years. Histologic or cytologic diagnosis of adenocarcinoma of stomach or~          gastric cardia (Siewart Classification Type III) Preoperative Stage T3-4NxM0 by~          endoscopic ultrasound, CT of the abdomen/pelvis and laparoscopy. (CT of the chest if it~          is a cardia lesion). Absence of malignant cells in peritoneal lavage fluid during~          laparoscopic examination.~           Patients must not have received any prior chemotherapy or hormonal therapy for the~          treatment of gastric cancer.~           Karnofsky performance status of 70 or higher. Estimated life expectancy of at least 12~          weeks.~           Adequate organ function including the following:~           - Bone marrow: White blood cells (WBC) at least 3.5 x 109/L Absolute neutrophil~          (segmented and bands) count (ANC) at least 1.5 x 109/L Platelets at least 100 x 109/L~          Haemoglobin at least 9g/dL~           - Hepatic: Bilirubin within upper limit of normal (ULN), ALT or AST not more than 2.5x~          ULN Alkaline phosphatase not more than 2.5x ULN.~           - Renal: creatinine not more than 1.5x ULN Signed informed consent by patient or legal~          representative. Patients with reproductive potential must use an approved contraceptive~          method if appropriate (eg, intrauterine device, birth control pills, or barrier device)~          during and for three months after the study. Females with childbearing potential must~          have a negative serum pregnancy test within 7 days prior to study enrollment.~           The study plans to recruit 30 patients in 12-18 months.~   "
239953|NCT00414258|"~     The purpose of this study is to compare the effects of mothers' skin-to-skin holding during~     feeding via a soother trainer with the effects of pacifier sucking on preterm infant~     biobehavioural responses during and immediately after a painful procedure~      Hypothesis:~        1. When held by their mothers during blood collection, preterm infants will show less pain~          reaction than when sucking on a pacifier.~        2. Following holding during the blood collection, mothers will find no differences in their~          infants' feeding ability.~   "
239954|NCT00414245|"~     The purpose of this study is to determine whether metformin is effective and safe in the~     treatment of diabetes in pregnancy.~   "
239955|NCT00414232|"~     Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving~     Chemo-Radiotherapy.~   "
239956|NCT00414219|"~     The purpose of this study is to assess visual quality of patients with non-penetrating,~     non-metallic, stable corneal foreign bodies. Visual quality will be assessed by examining~     visual acuity, wavefront analysis and contrast sensitivity. Drawings, photographs, and~     confocal microscopy will be used to document clinical examination of the cornea at baseline~     and on follow-up examinations.~   "
239957|NCT00414206|"~     This is a Phase II randomized, double-masked study comparing the safety and efficacy of~     ATG003 (mecamylamine HCl) 1.0% and 0.3% ophthalmic solutions to placebo in patients with~     neovascular (wet) age-related macular degeneration (NV-AMD).~   "
239958|NCT00414193|"~     Nosocomial bloodstream infections are important causes of morbidity and mortality caused by~     AmpC beta-lactamase-producing Enterobacteriaceae. The information collected will optimize the~     management of patients with nosocomial bloodstream infections.~   "
239959|NCT00414180|"~     To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless~     tobacco users.~   "
239960|NCT00414167|"~     This research study is designed to look at the effectiveness of bupropion for reducing binge~     eating in overweight persons with binge eating problems. Participants in the study will~     receive either bupropion or placebo (sugar pill, inactive medication) as an outpatient for~     eight weeks. In addition, participants will be given the option to receive 8 weeks of free~     behavioral weight loss treatment. This treatment, known to be effective for reducing binge~     eating and helping people lose weight, will be administered following the medication phase~     and at no cost.~      It is expected that compared to placebo, bupropion will produce greater reductions in binge~     eating.~   "
239971|NCT00414024|"~     This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation~     in patients with non-cancer pain.~      Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive~     the treatment as follows:~      Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod~     12 mg o.d. using an allocation ratio of 1:1.~      Patients who enter this study AFTER the core study interim analysis receive the treatment as~     follows:~      Patients will be assigned to receive the selected tegaserod dose regimen (as determined by~     the core study interim analysis) in an open label fashion.~   "
239972|NCT00414011|"~     The purpose of this study is a prospective,double-blinded, randomized trial to compare the~     rate of healing following PRK after the use of two commercially available 4th generation~     fluoroquinolones, moxifloxacin and gatifloxacin.~   "
240107|NCT00412191|"~     This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine~     XR in healthy male and female volunteers~   "
239961|NCT00414154|"~     Modification of individual life style factors and fall prevention programmes may have~     significant positive effects on fracture incidence. Also, a large number of studies have~     demonstrated that pharmacological therapy of osteoporosis is effective; however non-adherence~     to such therapy is a well recognized problem. Few studies, however, have examined the effect~     of particular patient education programmes on knowledge and adherence to therapy.~      We hypothesised that a group-based, multi-disciplinary, education programme increases the~     total quality of treatment for patients with osteoporosis, Patients' knowledge on~     osteoporosis and adherence with pharmacological therapy ect.~      A total of 300 patients, recently diagnosed with osteoporosis and started on specific~     treatment, were randomised to either the school or control group. In the school-group,~     patients attended four classes with 8-12 participants during four weeks (a total of 12~     hours). Teaching was performed by nurses, physiotherapists, dieticians, and doctors and was~     based on dialogs and situated learning. The classes covered facts on osteoporosis,~     fractures and pain, diet, preventive measures, balance and exercise, and medical~     treatment. Teaching was designed to increase empowerment. The control group were offered the~     department's standard treatment including follow-up visits.~      All 300 patients received questionnaires regarding Knowledge about Osteoporosis, Level of~     Adherence, Quality of life, Dietary calcium intake, Level of physical activity, Falls~     events registered every month by postcard, at inclusion and after 3, 12, and 24 month. BMD~     was examined by DXA-scan at inclusion and after 12 and 24 month. The last patient will answer~     the questionnaires first of May 2007.~   "
239962|NCT00414141|"~     Grass MATA MPL has been developed by Allergy Therapeutics (UK) Ltd. to provide pre-seasonal~     specific immunotherapy for patients with proven type I hypersensitivity to cross reacting~     grass pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma~     bronchiale. The purpose of this study is to compare the efficacy of Grass MATA MPL versus~     placebo in grass-allergic subjects following 4 subcutaneous injections of study medication~     administered before the start of the 2007 grass pollen season.~   "
239963|NCT00414128|"~     The purpose of this study is to investigate whether mycophenolate mofetil is effective as~     treatment for new cases of ANCA associated vasculitis.~   "
239964|NCT00414115|"~     The purpose of the study is (1) to identify and collect samples from children and adults who~     take drugs and have adverse drug reactions AND children and adults who take drugs and do not~     experience any adverse drug effects; (2) to determine if genetic differences between the two~     groups contribute to causing the adverse drug reactions; and (3) to develop patient specific~     drug dosing guidelines to prevent future adverse drug reactions. We also wish to compare the~     use of prescription drugs, medical and hospital services and vital statistics between BC~     participants who experience adverse drug reactions and those who do not.~      Study hypothesis: Genetic differences may contribute to patients' response to drugs and may~     be responsible for adverse drug reactions.~   "
239965|NCT00414102|"~     The purpose of this study is to determine the subjective treatment effects of ramelteon, once~     daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in~     adults with chronic insomnia.~   "
239966|NCT00414089|"~     The purpose of this study is to see how well Zevalin works in the treatment of low grade~     indolent B-cell lymphoma when given to patients who have not had any previous treatment for~     their lymphoma and who otherwise would be followed on a watch & wait policy.~   "
239967|NCT00414076|"~     The goal of this clinical research study is learn if taking Femara (letrozole) after a~     hysterectomy (surgical removal of the uterus) for uterine leiomyosarcoma will delay or~     prevent the cancer from coming back.~   "
239968|NCT00414063|"~     This study will examine whether there are differences in energy (calories) losses in stool~     and urine between lean and obese people. People gain weight when the amount of calories in~     the food they eat is greater than the amount of calories their body uses to support its~     functions and activities. The balance between caloric intake and expenditure may be affected~     by the amount of calories from food that is not absorbed but is lost in stool and urine. This~     study will examine whether differences in food absorption are related to obesity.~      Healthy normal volunteers between 18 and 45 years of age with a body mass index (BMI) of~     18-25 kg/m2 or less than 35 kg/m2 may be eligible for this 15-day study. Participants are~     admitted to the Clinical Research Unit at the Phoenix Indian Medical Center for the study.~      Participants undergo the following tests and procedures:~        -  Experimental diets with dye marker: Subjects are fed a 2400-calorie diet and a~          3400-calorie diet for 3 days each. On the first of the day of each diet, a blue dye~          marker is added to the breakfast meal. A red marker is added to the breakfast meal of~          the first day after the diet period. Urine is collected beginning after breakfast on the~          first day of the diet and until before breakfast on the last day of the diet. Stool~          samples are collected during the entire diet period, and until the appearance of the red~          dye in the stool.~        -  24-hour metabolic rate in the respiratory chamber: After the first diet period, subjects~          spend 24 hours in a respiratory chamber to measure the number of calories the body burns~          a day and to assess the energy balance between intake and expenditure.~        -  Stool sample: Stool samples are collected on days 1 and 2 of the study to look for~          parasites or internal bleeding that may affect nutrient absorption.~        -  DXA scanning: This scan uses a low dose of X-rays to measure body fat.~        -  Oral glucose tolerance test: For this test for diabetes, an I.V. line (needle attached~          to a small plastic tube) is inserted into an arm vein. The subject drinks a sugar~          solution. Small blood samples are drawn from the I.V. before the subject drinks the~          solution and at five intervals during the 3 (Omega)-hour test period.~        -  Fasting blood tests: On the first day of each diet and on the day after each diet is~          completed a blood sample is drawn before breakfast to measure hormones that may affect~          the ability to absorb food.~      At the end of the study, some participants may be asked to repeat the experimental diets and~     stool and urine collections.~   "
239969|NCT00414050|"~     This study was conducted in healthy infants and will provide new immunogenicity and safety~     data for the modified process hepatitis B vaccine. This study was conducted to address the~     following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the~     modified process hepatitis B vaccine compared with a 10 microgram dose of the modified~     process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and~     to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).~   "
239970|NCT00414037|"~     If you are age 20-55 years old and have trouble falling or staying asleep, then please~     contact a UCSD research team to find out how a study drug affects these symptoms and how your~     brain works. This is a one-week experimental pain research study using a study drug compared~     to placebo. Your participation will include questionnaires, a physical exam and functional~     Magnetic Resonance Imaging (fMRI) brain imaging techniques. We will test pain perception by~     applying brief mild to moderate heat pain to the forearm, and also have you perform simple~     computer tasks while we image and record brain activity using fMRI.~   "
239973|NCT00413998|"~     The study is a randomised controlled trial comparing two treatment strategies for patients~     with moderate functional ischaemic mitral regurgitation undergoing coronary artery bypass~     grafting (CABG). Patients will be randomised to receive either CABG alone or CABG plus mitral~     annuloplasty. The objective of the study is to determine if mitral annuloplasty in addition~     to CABG improves outcome in patients with moderate functional ischaemic mitral regurgitation.~   "
239975|NCT00413972|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3~     study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10~     mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg)~     compared to placebo administered daily for 8 consecutive weeks in subjects with primary~     hypercholesterolemia (LDL-C >3.64 mmol/L [140 mg/dL]). The efficacy of daily Vytorin versus~     placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily~     Vytorin versus placebo with respect to change in the concentrations of total cholesterol,~     triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be~     assessed.~   "
239976|NCT00413959|"~     Overall response rate and Time to disease progression using this regimen in patients with~     low-grade B-Cell Non-Hodgkin's Lymphoma.~   "
239977|NCT00413946|"~     The main goal of this trial is to investigate whether early administration of human~     erythropoietin (EPO) in very preterm infants improves neurodevelopmental outcome at 24 months~     corrected age.~      This study is designed as randomized, double-masked, placebo controlled multicenter study~     involving at least 420 patients.~   "
239978|NCT00413933|"~     The purpose of this study is to determine whether the comprehensive multidisciplinary~     intervention (geriatrician, physical therapist and occupational therapist falls risk~     assessment and intervention)is effective in the falls prevention in the community dwelling~     elderly.~   "
239979|NCT00413920|"~     This study will investigate the efficacy and safety of a steroid avoidance regimen in~     comparison with steroid treatment in combination with an initially higher dose of~     enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal~     transplant recipients. Patients will be randomly allocated to receive either EC-MPS or~     steroids in combination with EC-MPS. Patients of both treatment groups will receive~     monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.~   "
239980|NCT00413894|"~     This single arm study will assess the efficacy and safety of intravenous Mircera,~     administered with pre-filled syringes, for the treatment of anemia in patients with chronic~     kidney disease who are on dialysis, and who have previously received treatment with epoetin~     alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of~     Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin~     they were receiving in the week preceding study start. The anticipated time on study~     treatment is 3-12 months, and the target sample size is 500+ individuals.~   "
239981|NCT00413881|"~     The purpose of this study is to conduct a prospective clinical trial to compare conventional~     and WFG LASIK for enhancements on post-LASIK patients. Differences in safety, efficacy,~     visual quality, and refractive stability will also be compared during this study.~   "
239982|NCT00413868|"~     The purpose of this study is to conduct a prospective assessment of small target contrast~     sensitivity and disability glare in refractive surgery. Study subjects will undergo the~     treatment of their choice (PRK or LASIK) and will be evaluated before and after treatment.~     Evaluations will include best corrected visual acuity, uncorrected visual acuity,~     psychometric questionnaire, pupil size, biomicroscopic examination, manifest refraction,~     wavefront measurements, low contrast acuity, and contrast sensitivity at normal and at low~     luminance with and without disability glare.~   "
239983|NCT00413855|"~     It is questionable whether elective appendectomy can effectively reduce pain in persistent or~     recurrent lower abdominal quadrant pain due to chronic appendicitis.~      A single centre randomised double-blind sham surgery controlled clinical trial studied the~     effects of elective laparoscopic appendectomy on postoperative pain perception in patients~     with persistent or recurrent lower abdominal quadrant pain on abdominal pain at 6 months~     postoperatively. Secondary outcome was the relation between clinical response and the~     appendix’ histopathology. The analysis was performed on an intention-to-treat basis. Pain~     scores were compared using a Fisher’s exact test.~   "
239984|NCT00413842|"~     This study will evaluate whether applying electrical stimulation on the cerebellum (posterior~     and lower part of the brain) can influence brain excitability and hand movement performance.~      A new technique became available to stimulate the brain: transcranial direct current~     stimulation (tDCS), which could improve the ability to learn. Researchers do not know whether~     applying tDCS over the cerebellum could also influence motor function, and they want to~     examine changes in brain excitability, by using transcranial magnetic stimulation (TMS).~      Patients ages 18 to 40 who are not pregnant may be eligible for this study. They will come to~     NIH for a medical history and completing a questionnaire about memory and attention. There~     will be five experiments, each up to 5 hours, for about 1 to 5 weeks, in which patients~     perform tasks like pinching a special device between the thumb and index fingers, or reaching~     for target objects on the computer screen. Patients will receive mild electrical stimulation~     over a different part of the head each day. Some experiments are done without the electrical~     current, but patients will not know which ones are with or without stimulation. There are~     also short questionnaires about attention, fatigue, and mood, to be completed before, during,~     and after each experiment.~      Patients will be connected to an electromyography (EMG) machine, to measure electrical~     activity of muscles. Electrodes are taped to the skin over one small hand muscle. TMS allows~     electrical pulses to pass through the brain to stimulate it. TMS is used at the beginning of~     each experiment to determine the precise location on the scalp of two target areas:~     cerebellum and motor cortex. TMS is a safe procedure. Discomfort, headache, or nausea can~     occur, but all symptoms usually go away promptly. During motor learning under tDCS, also a~     safe procedure, patients sit in a comfortable chair, and the arm and wrist and arm are kept~     still. Sponge electrodes are applied on the chin, back of the head, neck, collarbone, lateral~     part of the head, or above the eyebrow. A small electrical current is passed between~     electrodes. Patients may feel an itching or tingling sensation under the electrodes or see~     slight light flashes. tDCS is applied for 20 to 30 minutes. A magnetic resonance imaging~     (MRI) scan, which may also be involved, uses a strong magnetic field and radio waves to~     obtain images of body organs and tissues. Patients lie on a table in a cylinder and may be~     asked to lie still for up to 60 minutes at a time.~      This study will not have a direct benefit for participants. However, knowledge gained may~     help researchers identify ways to improve movement in people with a brain injury, such as~     chronic stroke.~   "
239985|NCT00413829|"~     This study is an evaluation of the short term effects on CNV perfusion of a same-day~     administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of~     Lucentis® (ranibizumab, 0.3 mg). An evaluation of the short term effects on CNV perfusion of~     this combined treatment is needed for better understanding of treatment effects.~   "
239986|NCT00413816|"~     The purpose of the study is to determine the trigger for blood transfusions in Israeli ICU~     patients and the possible effects of anemia on the post ICU discharge course.~   "
239987|NCT00413803|"~     The investigators hypothesize that an increase in the duration of dialysis session in thrice~     weekly center hemodialysis may provide better outcome, less morbidity, higher quality of~     life, lesser requirement of medications, and lower total cost.~   "
239988|NCT00413790|"~     This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine~     on cardiovascular parameters in healthy subjects 50 years of age and older~   "
239989|NCT00413777|"~     This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to~     determine the maximally-tolerated dose and acquire pilot efficacy data in patients with~     autosomal dominant polycystic kidney disease (ADPKD).~   "
239990|NCT00413764|"~     Tibolone has been registered for treatment of menopausal symptoms. It is, however, not known~     what the effects are of tibolone in postmenopausal women diagnosed with sexual dysfunction.~     This is important because there is currently no approved treatment of libido problems in~     postmenopausal women. Therefore, the primary aim of this study was to compare the effects of~     tibolone with an estrogen/progestogen skin patch in postmenopausal women diagnosed sexual~     dysfunction.~   "
239991|NCT00413751|"~     The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic~     solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.~   "
239992|NCT00413738|"~     The aim of this prospective randomised controlled trial is to compare the incidence of~     catheter-related bloodstream infection in 2 groups of patients with hemato-oncological~     disease:~      Group A: heparin-coated central venous catheters (Control Group) Group B: antiseptic-coated~     (chlorhexidine-silver sulfadiazine) central venous catheters~   "
239993|NCT00413725|"~     The purpose of this study is to determine the safety, efficacy, and tolerability of a~     three-dose regimen of an adenovirus-based HIV-1 vaccine in healthy South African adults.~   "
239994|NCT00413712|"~     The purpose of this study is to determine the efficacy and effectiveness of calcium channel~     blockers and adenosine in the treatment of Supraventricular Tachycardia.~   "
239995|NCT00413699|"~     The purpose of this study is to determine the long-term effectiveness and safety of~     CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study~     only after participating in another qualifying study of CP-690,550~      A sub-study will be conducted within the A3921024 study, this study will evaluate the immune~     response to pneumococcal and influenza vaccines in patients receiving CP-690,550~   "
239996|NCT00413686|"~     This is an open-label, multi-center, dose-escalation, Phase I study to evaluate the safety,~     tolerability, and pharmacokinetics and to investigate biomarker changes of AZD7762~     administered as a single intravenous unit and in combination with gemcitabine. The study is~     sponsored by AstraZeneca.~   "
239997|NCT00413673|"~     The objective of this study is to conduct a prospective clinical trial to evaluate the safety~     and efficacy fo the VISX Excimer Laser system for the treatment of naturally occurring low to~     moderate myopia, with or without low levels of astigmatism, in U.S. Army personnel.~   "
239998|NCT00413660|"~     The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6~     dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with~     active rheumatoid arthritis.~   "
239999|NCT00413647|"~     Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD~     subjects both male and female between the ages of 50-85. Nine normal controls will undergo~     repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal~     healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging~     only.~   "
240000|NCT00413634|"~     Age related differences in response to a drug could arise from variation in pharmacokinetic~     (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety~     profile of anagrelide is well established through a well-documented clinical trial programme~     in patients of all ages, no formal studies have been carried out to investigate whether the~     PK profile of anagrelide and its metabolites is altered with age.~      This study is designed to allow comparisons to be made in terms of pharmacokinetics of~     anagrelide and its metabolites between elderly (≥ 65 years) and young (18-50 years) ET~     patients~   "
240001|NCT00413621|"~     The study will investigate the possibility of detecting early signs of Alzheimer's disease~     using magnetic resonance imaging (MRI). If plaques, types of damage, can be imaged by MRI,~     the procedure could be used in clinical trials and may also help in the clinical diagnosis of~     patients. Alzheimer's disease, a progressive disease, is a major cause of functional~     disability and institutionalization, affecting 4.5 million people in the United States, a~     number that will more than triple by 2030 as the population ages.~      Patients ages 55 to 90 who have mild symptoms of Alzheimer's disease and who are in good~     health may be eligible for this study. Twenty patients will be recruited from Johns Hopkins'~     Alzheimer's Disease Research Center. There will also be a control group of 20 people without~     the disease.~      Healthy patients and volunteers will have a clinical MRI brain scan and a neurological~     examination at Johns Hopkins Hospital before the 7T MRI scan. Also, patients will have a~     Mini-Mental State Examination, a standardized test to evaluate memory, done at Johns Hopkins~     within 4 weeks of the 7T MRI. This study uses a device situated at the NIH Bethesda campus~     that operates at a high magnetic field strength of 7 Tesla, that is, the unit used to measure~     the strength of a strong magnet. The Food and Drug Administration has categorized MRI up to 8~     Tesla as not a significant health risk. MRI scanning is routinely done at magnetic field~     strengths up to 4T. MRI images are created through the use of a large magnet and radio waves.~     During the procedure, patients lie on a table moved into a strong magnetic field. They are~     asked to lie still but can easily hear and speak to research staff. A respiratory belt is~     placed around the chest, and a finger probe is placed on the finger, to monitor breathing and~     heart rate. For obtaining a better picture, a special lightweight coil may be placed on or~     around the patient's head. The scan takes from 20 minutes to 2 hours, with most scans at 45~     to 90 minutes. Due to limited experience with the use of 7T MRI and its investigational~     nature, patients will be asked to complete a questionnaire immediately after the study. They~     will be asked about their comfort level and if they experienced unusual sensations. Answers~     will be reviewed with patients by an experienced MRI investigator to get details of any~     unusual sensations reported. If patients experience unusual sensations, they are followed up~     by phone within 24 hours.~      This study wi...~   "
240002|NCT00413608|"~     To test pharmacodynamic response to clopidogrel 150mg once daily during 7 days in healthy~     subjects carriers of a mutated allele (*2) associated with CYP2C19 deficiency and non~     responders to the usual regimen of 75 mg once daily~   "
240003|NCT00413595|"~     New studies indicate that in about 1 - 2 percent of the younger stroke patients the cause~     could have been an undiagnosed genetic disease, the so called Fabry disease. In this case~     certain fat molecules are not digested and broken down by the body - but remain in the cells.~     These fat molecules build up to dangerous levels, which start to damage the body, because~     they accumulate e.g. in the walls of the blood vessels. This accumulation in the blood~     vessels of the whole body may cause life-threatening malfunctions in the brain, inducing a~     stroke.~      The purpose of this study is to investigate the stroke rehabilitation of Fabry patients~     during different therapeutic standard approaches for stroke and for Fabry disease (if any).~     During this study, stroke patients with Fabry disease will be monitored in greater detail to~     determine whether the differences in treatment are significant for patient recovery and on~     what they depend.~   "
242083|NCT00385840|"~     The purpose of this study is to evaluate the immunogenicity and the safety of a second~     vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in~     elderly aged 60 years and above~   "
240004|NCT00413582|"~     The objective of this study is to scientifically evaluate two different management strategies~     for post-operative pain after pectus excavatum repair.~      The hypothesis is that pain management without an epidural decreases hospital stay without~     compromising comfort.~      The primary outcome variable is length of hospitalization after the intervention.~   "
240005|NCT00413569|"~     The specific aim of this study is to demonstrate that inserting a breathing tube using a~     standard laryngoscope with the patient fully anesthetized is a safe and effective means of~     securing the airway in a patient with cervical spine disk herniation or stenosis. The two~     groups compared are composed of those who are intubated with direct laryngoscopy and those~     who are intubated with a fiberoptic scope.~   "
240006|NCT00413556|"~     We plan to determine changes in the immune system during the allergic response to grass~     pollen allergens. We have chosen a particular element of the immune response, the~     immunoglobulin G4 (IgG4) as an indicator.~      We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense~     specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE~     mediated) and late (cell mediated) allergic response.~   "
240007|NCT00413543|"~     This is a study to evaluate the effects of early pulmonary rehabilitation within 10 days~     after discharge from the hospital after a COPD exacerbation on exercise tolerance,~     exacerbations, re-admissions and the quality of life during 6 months.~   "
240008|NCT00413517|"~     The purpose of this study is to evaluate the safety and efficacy of Epi-Lasik in U.S. Army~     personnel who have naturally occurring myopia with or without astigmatism. The data from this~     control group will be collected in such a way as to be comparable to data sets from study~     groups undergoing wavefront guided PRK, conventional PRK, and related laser refractive~     surgery procedures.~   "
240009|NCT00413504|"~     To determine whether fondaparinux as monotherapy without warfarin is effective and safe for~     long-term (90 days) treatment of DVT and/or PE, thus gaining new long-term experience and~     data using fondaparinux.~   "
240010|NCT00413491|"~     The purpose of the study is to determine whether MR of the breast is a better screening tool~     than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene~     mutations.~   "
240011|NCT00413478|"~     The objective of this study is to determine the safety and efficacy of Azacytidine in~     fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and~     T-cell prolymphocytic leukemia (T-PLL).~   "
240012|NCT00413465|"~     The purpose of the present protocol is to study whether endotoxemia will affect the renal~     blood flow in type 2 diabetics and healthy volunteers.~   "
240013|NCT00413452|"~     Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP~     therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.~   "
240014|NCT00413439|"~     Patients who undergo chemotherapy for leukemia will receive study medication for prevention~     of fungal infections. The study investigates the safety and tolerability of two different~     dosages, the efficacy in prevention of fungal diseases.~   "
240015|NCT00413426|"~     This purpose of this study is to compare the how the body changes the blood level of a single~     dose of darifenacin when given as 7.5 mg modified release tablet and the modified release~     liquid suspension (1.5 mg/ml) under fasted and fed conditions in healthy subjects.~   "
240016|NCT00413413|"~     This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine~     in adult patients with mild to moderate hypertension.~   "
240017|NCT00413400|"~     This study will investigate whether etanercept will result in improved inflammatory indices,~     glucose tolerance and endothelial function in patients with the metabolic syndrome.~   "
240018|NCT00413387|"~     The aim of this study was to compare the efficacy and tolerability of the fixed combination~     beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.~   "
240019|NCT00413374|"~     To investigate the efficacy and safety of once daily enoxaparin as a bridge to warfarin for~     the outpatient treatment of acute deep venous thrombosis or pulmonary embolism.~   "
240020|NCT00413361|"~     The main objective of study PLUS is to determine the potential benefits of individualized HCQ~     dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml~   "
240021|NCT00413348|"~     Insulin-resistance in type 2 diabetes is associated with chronic inflammation.~     Anti-inflammatory actions might increase sensitivity to insulin. Since some probiotics have~     anti-inflammatory properties, ingestion of the probiotic bacteria Lactobacillus Acidophilus~     NCFM might increase insulin-sensitivity.~      The inflammatory response to endotoxin injection and the insulin-sensitivity is examined~     before and after four weeks ingestion of probiotics.~   "
240022|NCT00413335|"~     The purpose of the study is to determine whether treatment of children and adolescents with~     Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin~     sensitivity and glucose tolerance.~   "
240023|NCT00413322|"~     This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with~     advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor~     activity, and how the study drug behaves within the body when given with 5-Fluorouracil~     (5-FU).~   "
240024|NCT00413309|"~     To determine the rate of symptomatic and asymptomatic gastrointestinal erosions and~     ulcerations in patients on dual antiplatelet (aspirin and clopidogrel) therapy after~     percutaneous coronary intervention (PCI).~   "
240025|NCT00413296|"~     The purpose of this study is to evaluate the short-term efficacy and safety of levetiracetam~     in post-traumatic stress disorder (PTSD) and to evaluate continuation effects of~     levetiracetam in preventing PTSD relapse. The hypothesis is that levetiracetam will be safe~     and effective in preventing relapse of PTSD.~   "
240026|NCT00413283|"~     The purpose of this study is to identify an effective, well tolerated dose and schedule of~     romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia~     (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.~   "
240027|NCT00413270|"~     This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or~     -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with~     nilotinib. Patients will be provided access to nilotinib until the drug is available on the~     market.~   "
240028|NCT00413257|"~     Postoperative pain after major surgery is consecutive not only to the nociceptive inputs~     coming from the surgical lesion, but also to peripheral and central neuronal sensitization.~     This lead to postoperative hyperalgesia and allodynia that are enhanced by the per operative~     use of high opioid doses. Anti-NMDA drugs have been reported as able to reduce this~     sensitization process and then to decrease acute morphine tolerance during the postoperative~     period. Nefopam has been lately shown to combine in experimental trials analgesic and anti~     hyperalgesic effects. The aim of this study is to compare anti-hyperalgesic effects of~     nefopam given either before incision and continuously for the following 48hours or starting~     from the end of the surgery and given for 48hours to a control group that would receive~     placebo for 48hours. Postoperative analgesia will be based on morphine PCA. Pain scores,~     hyperalgesia, allodynia, postoperative morphine consumption, and development of chronic pain~     will be the main criteria that will be evaluated during this study~   "
240029|NCT00413244|"~     The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as~     a testosterone replacement help bring the testosterone to an acceptable level and to find out~     if it will help improve heart condition in males with coronary artery disease (CAD) following~     successful percutaneous coronary intervention.~   "
240030|NCT00413231|"~     This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft~     to treat thoracic aortic aneurysms.~   "
240031|NCT00413218|"~     The purpose of the study is to compare the safety and efficacy of isavuconazole versus~     caspofungin followed by voriconazole in the treatment of candidemia and other invasive~     Candida infections.~   "
240032|NCT00413205|"~     This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus~     placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy.~     Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive~     either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition~     to their standard therapy. Following the double-blind treatment period, patients will enter a~     4-week follow-up period. The anticipated time on study period is 1-2 years, and the target~     sample size is 100-500 individuals.~   "
240033|NCT00413192|"~     The purpose of this study is to evaluate the therapeutic activity and safety of E7389 in~     patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.~   "
240034|NCT00413179|"~     The purpose of our study was to conduct a placebo controlled, double-blind randomized trial~     in chronic oligoovulatory or anovulatory , hyperandrogenic, infertility patients comparing~     the effects of adjuvant metformin plus clomiphene citrate to clomiphene citrate plus placebo~     on pregnancy rates and ovulation rates. We hypothesized that combining metformin with~     clomiphene citrate would result in higher ovulation and pregnancy rates in hyperandrogenic~     women who have chronic oligoovulation or anovulation as the sole etiology for their~     infertility and who have unknown responsiveness to clomiphene citrate.~   "
240035|NCT00413166|"~     The goal of this clinical research study is to learn if the combination of arsenic trioxide~     (ATO) with ATRA and possibly idarubicin is effective in treating patients with~     newly-diagnosed APL.~   "
240036|NCT00413153|"~     To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat~     in HIV-infected patients.~   "
240037|NCT00413140|"~     Background Chronic airway inflammation is present in cystic fibrosis. Non-invasive~     inflammometry may be useful in disease management.~      Objective We studied 1) the ability of fractional exhaled nitric oxide and inflammatory~     markers (acidity, nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor~     necrosis factor-α, interleukin-2,-4,-5,-10) in exhaled breath condensate, to discriminate~     between cystic fibrosis and control children, and, 2) the relationship of biomarkers with~     control and severity of cystic fibrosis.~      Methods In 98 children (48 cystic fibrosis / 50 controls), condensate was collected using a~     glass condenser. Exhaled nitric oxide was measured using the NIOX®.~   "
240038|NCT00413127|"~     The purpose of this study is to comparing effects of intravenously (IV) administered~     lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing~     elective colorectal surgery~   "
240039|NCT00413114|"~     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow~     unchecked when an oncogeneic signal is present. Obatoclax is designed to restore apoptosis~     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process~     of cell death that is often inhibited in cancer cells.~      This is a multi-center, open-label, Phase II study of obatoclax administered in 2-week cycles~     to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or~     thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or~     commercial agents or therapies other than those described herein may be administered with the~     intent to treat the patient's malignancy. Supportive care measures including those directed~     at controlling symptoms resulting from Myelodysplastic Syndromes are allowed~   "
240040|NCT00413101|"~     This single arm study will determine the effects of complete anemia correction in anemic~     patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon.~     Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be~     treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to~     reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart~     function and quality of life will be measured before and after anemia correction. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100~     individuals.~   "
240041|NCT00413088|"~     Open pharmacokinetic study with 5 parallel groups and two treatment phases (bemiparin 3,500~     IU multiple dose and bemiparin 115 IU/kg single dose). The bemiparin pharmacokinetic profile~     will be assessed by measuring its effects on the coagulation cascade. Plasma anti-Xa activity~     (measured using chromogenic amidolytic assay) in IU per milliliter will be the primary~     endpoint to assess the pharmacokinetic profile of bemiparin.~   "
240042|NCT00413075|"~     This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will~     be given once or twice daily at various dosing schedules to patients with solid tumors. Doses~     will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort~     of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing~     schedule.~   "
240043|NCT00413062|"~     The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding~     patterns (cycle control), general safety and acceptability of the nomegestrol~     acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged~     18-50 years.~   "
240044|NCT00413049|"~     This study will evaluate the safety and efficacy of the fixed combination of~     valsartan/amlodipine in adult patients with mild to moderate hypertension~   "
240045|NCT00413036|"~     Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle.~     Treatment will continue until disease progression, or unacceptable adverse events develop~   "
240046|NCT00413023|"~     The purpose of this study is to assess the efficacy, safety and tolerability of GW679769~     patients with Major depressive Disorder (MDD).~   "
240047|NCT00413010|"~     The primary objective of this study is to evaluate the efficacy of pregabalin as compared to~     placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be~     measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from~     baseline observed following 8 weeks of double-blind treatment or at earlier termination~     during the double-blind treatment phase and analyzed using a mixed linear model for repeated~     measures.~   "
240048|NCT00412997|"~     The phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult~     patients with advanced solid tumors or Cutaneous T-cell lymphoma~   "
240049|NCT00412984|"~     The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is~     as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in~     subjects with atrial fibrillation and risk factors for stroke.~   "
240050|NCT00412971|"~     The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted~     Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with~     suspicion of non-invasive bladder cancer.~      The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix~     assisted TURB compared to standard white light TURB.~   "
240051|NCT00412958|"~     A multicenter study to compare multiple doses of intravitreal microplasmin in patients~     undergoing surgical vitrectomy.~   "
240052|NCT00412932|"~     This 14 week study will examine the ability of olmesartan medoxomil to lower the blood~     pressure of patients 65 years of age or older with high blood pressure. The medication being~     tested has been approved by the FDA for the treatment of high blood pressure.~   "
240053|NCT00412919|"~     This is a Phase II trial evaluating the overall response rate, safety and tolerability to~     azacitidine in patients with relapsed or refractory multiple myeloma.~   "
240054|NCT00412906|"~     The aim of the present protocol is to study gene activity in fat and muscle tissue in type 2~     diabetics and healthy volunteers after injection of E. coli endotoxin.We hereby hope to gain~     insight in some mechanisms behind the association between inflammation and insulin~     resistance.~   "
240055|NCT00412893|"~     The purpose of this study is to compare the efficacy and safety of isavuconazole versus~     voriconazole in the treatment of patients with invasive aspergillosis.~   "
240056|NCT00412880|"~     Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in~     second line treatment in sensitive-relapse SCLC patients.~   "
240057|NCT00412867|"~     The purpose of this study is to confirm the efficacy and safety of intravenously administered~     alteplase in patients with acute ischemic stroke based on the rate of recanalization assessed~     by magnetic resonance angiography (MRA), the rate of patients with a modified Rankin Scale~     (mRS) score of 0-1, and the incidence of symptomatic intracranial hemorrhage (sICH), in~     comparison with the data reported in the current literature.~   "
240058|NCT00412854|"~     This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and~     Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and~     immunogenicity.~   "
240059|NCT00412841|"~     This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show~     reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a~     disease resulting from the loss of blood supply to the bones which can cause the bone to~     collapse. The collapse of bone may require a surgical replacement of the joint and can be~     disabling for life. Avascular necrosis is presently not preventable but research has shown~     that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in~     animals. We therefore hypothesize that lipitor will reduce the incidence of avascular~     necrosis in lupus patients taking high dose steroids.~   "
240060|NCT00412828|"~     This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in~     patients who have unresectable stage III or stage IV melanoma and have failed no more than 1~     line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once~     every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the~     MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy~     of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be~     explored.~   "
240061|NCT00412815|"~     The purpose of this study was to determine the effects of exercise training on insulin~     resistance in subjects with coronary artery disease independent of changes in weight, diet,~     or the effect of an acute bout of exercise. We hypothesized that subjects with CAD and high~     normal or impaired glucose tolerance performing 12 weeks of aerobic exercise training while~     on a non weight-reducing diet, would have a greater decrease in insulin resistance than~     controls measured at 72 hours following their last bout of exercise.~   "
240062|NCT00412802|"~     The objective of the VALIDE study is to validate that a 25% dose reduction of enoxaparine in~     patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and~     hospitalized for an acute coronary syndrome provides at steady state a similar anti Xa level~     in plasma compared to that obtained in patients without renal failure and receiving the usual~     dose of 1 mg/kg subcutaneously every 12 hours. 140 per - protocol patients are planned to be~     included.~   "
240063|NCT00412789|"~     The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced~     solid tumors.~   "
240064|NCT00412776|"~     The purpose of this study is to compare the safety and efficacy of Proxinium plus best~     supportive care with best supportive care only for patients with squamous cell head and neck~     cancer.~   "
240065|NCT00412763|"~     The overall objective of this project is to assess whether Silymarin therapy shortens illness~     or prevents complications in patients with acute hepatitis. We will specifically compare~     responses in acute hepatitis patients treated with Silymarin to those given a control~     preparation of a vitamin supplements in a double blinded, randomized, placebo-controlled~     trial.~   "
240066|NCT00412750|"~     To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon~     alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to~     peginterferon alpha-2a monotherapy.~   "
240067|NCT00412737|"~     This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal~     prophylaxis of influenza in immunocompromised participants (as represented by transplant~     recipients). Transplant recipients enrolled when influenza is circulating in the community~     will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily~     (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will~     be recorded throughout the study.~   "
240068|NCT00412724|"~     The Food Acceptability Questionnaire (FAQ) is a self-report measure of palatability, ease of~     preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed~     or self-selected diet. This study intends to develop a reliable and valid food acceptability~     questionnaire for use in clinical studies in which dietary interventions are administered.~   "
240069|NCT00412698|"~     Primary :~      To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C),~     triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet~     in abdominally obese patients with dyslipidemia with or without other associated~     comorbidities.~      Main Secondary :~      To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist~     circumference (WC), body weight, glycemic and lipid parameters.~      To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.~      In selected sites, a sub study will be conducted to determine the effect of 12 months of~     Rimonabant on additional lipoprotein and inflammatory parameters.~   "
240070|NCT00412685|"~     Patients with congenital heart disease in whom the right ventricle is exposed to pressure or~     volume overload show progressive systolic dysfunction of the right ventricle, the fact of~     which conveys substantial morbidity and mortality. The aim of this study is to investigate~     the myocardial perfusion in these patients by myocardial contrast echocardiography (MCE) in~     order to determine whether disturbed blood flow plays a role in the development of right~     ventricular systolic dysfunction.~   "
240071|NCT00412672|"~     The hypothesis of the current proposal is that collateral flow is an important determinant of~     myocardial protection during an ischemic event. Increased collateral flow for any given area~     at risk will decrease the myocardial damage caused by the occlusion of the infarct related~     epicardial artery.~      It is further hypothesized that myocardial salvage provided by collateral flow will decrease~     infarct size and this in turn will decrease LV dilatation post-myocardial infarction.~   "
240072|NCT00412659|"~     The trial compares excision in the midline at surgery for pilonidal disease versus excision~     lateral of the midline (Karydakis operation) at surgery for pilonidal disease by randomly~     allocating patients with pilonidal disease to two groups of surgeons, each group being~     trained for one of the two methods.~   "
240073|NCT00412646|"~     The purpose of this randomized (patients are assigned different treatments based on chance),~     placebo-controlled, dose-escalating trial is to evaluate the safety, tolerability and~     efficacy of different doses of TMC125 twice daily ( b.i.d.) when added to an individually~     optimized antiretroviral therapy (ART) for 48 weeks. Dose-escalation will be performed in two~     stages. In the first stage approximately one hundred and eighty HIV-1 positive, three-class~     ART experienced patients will be randomized to placebo, 400 or 800 mg of TMC125 b.i.d. In the~     second stage, approximately seventy patients will be randomized to placebo, 800 or 1200 mg~     TMC125 b.i.d. Stage 2 will be opened for enrollment after review of the available safety and~     efficacy data for a specified number of patients and concurrence by the Data Safety and~     Monitoring Board (DSMB). After all patients are treated for a period of 12 weeks, unblinding~     for the sponsor will occur. The trial will continue in a single-blind fashion (sponsor~     unblinded, but investigator and patient blinded) for up to 48 weeks. Upon completion of the~     initial 48 weeks of treatment, patients deriving clinical benefit, in the opinion of the~     investigator, will have the option to prolong the same treatment, in a single-blind setting~     up to a maximum of 144 weeks.~   "
240074|NCT00412633|"~     PACE Project researchers at UCSD are conducting a 2-year study to test the Men in Motion~     program. The study aims to learn more about how to help men lose weight, become more~     physically active, and improve their dietary habits. The study is sponsored by the National~     Institutes of Health.~   "
240075|NCT00412620|"~     The objective of this study is to explore the safety and efficacy of ABT-925 involving~     patients who meet the DSM-IV-TR (Diagnostic and Statistical Manual of Medical Disorders,~     Fourth Edition Text Revision) criteria for an acute exacerbation of schizophrenia or~     schizoaffective disorder.~   "
240076|NCT00412607|"~     The primary objective is to provide additional corroborative safety and efficacy data for the~     Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular~     Tachycardia.~   "
240077|NCT00412594|"~     The goal of this clinical research study is to learn if treatment with 2CDA (cladribine)~     followed by treatment with rituximab can help to control HCL. The safety of this combination~     treatment will also be studied.~      This is an investigational study. Both drugs are approved by the FDA and are commercially~     available. Their use together in this study, however, is experimental. A total of 150~     patients will take part in this study. All will be enrolled at MD Anderson.~   "
240078|NCT00412581|"~     Primary Objectives:~      1. To determine the maximum tolerated dose (MTD) of intravenous DTIC during the first 2~     cycles (6 weeks) of treatment when administered in combination with a fixed dose of oral~     Lenalidomide in patients with metastatic malignant melanoma previously untreated with~     systemic chemotherapy.~      Secondary Objectives:~        1. To define the recommended Phase II doses of Lenalidomide and DTIC when administered as~          combination therapy.~        2. To evaluate the safety and toxicity profile of combination Lenalidomide plus DTIC.~        3. To evaluate the preliminary efficacy of combination Lenalidomide plus DTIC.~   "
252578|NCT00245531|"~     The purpose of this study is to understand the effects of decreased functioning of the testes~     or ovaries on mental performance in males and females using illicit drugs excluding~     marijuana.~   "
240079|NCT00412568|"~     The purpose of this study is to:~        1. evaluate the safety and efficacy of conventional PRK in U.S. Army personnel who have~          naturally occurring myopia with or without astigmatism.~        2. compare the data from this control group to study groups undergoing wavefront guided~          PRK.~   "
240080|NCT00412555|"~     This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in~     children during the flu season. Children who would benefit from influenza prophylaxis when~     influenza is circulating in the community will receive treatment with Tamiflu syrup (or~     capsules) 30mg-75mg once daily (dependent on body weight) for 6 weeks. Safety data and~     influenza symptoms will be recorded throughout the study. The anticipated time on study~     treatment is <3 months, and the target sample size is <100 individuals.~   "
240081|NCT00412542|"~     Objectives:~      1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy~     with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or~     progressive malignant gliomas.~      1.2 To determine the rate of measureable clinical response in patients treated with~     Thalidomide and CPT-11.~      1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected~     toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.~      1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker~     for treatment effect.~   "
240082|NCT00412529|"~     This exploratory study is designed to determine the early viral kinetic profile during~     treatment with telbivudine or entecavir at multiple time points over 12 weeks.~   "
240083|NCT00412516|"~     The previously conducted JEV01 study looked at the immunogenicity and safety of the~     concurrent administration of Japanese Live Attenuated SA 14-14-2 and measles vaccines at the~     one month post vaccination time point. The purpose of the JEV01 study was to help ensure the~     safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its~     use in routine EPI programs. As a follow-on to JEV01, this study will enroll those infants~     who received both vaccines and completed the JEV01 study. This study, however, will provide~     crucial data to help ensure the long-term immunogenicity of the concurrent administration of~     these vaccines and provide valuable information to determine the use of these vaccines in~     routine immunization programs. This study is planned because in the original protocol for~     JEV01, long-term data points were not included. The hypothesis is that children who receive~     JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time have long-term (24~     and 36 months post vaccination) protection against these diseases at the same level as those~     who receive the vaccines at different intervals.~   "
240084|NCT00412503|"~     Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some~     types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas)~     cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly~     needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and~     TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both~     drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never~     been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting~     toxicities of each drug when associated and to assess efficacy of the combination.~   "
240085|NCT00412490|"~     Primary Objectives:~        1. To characterize smoking behaviors and body image in patients with oral cavity cancer~          prior to and following surgical procedures.~        2. To examine the relationship between smoking status and body image in this sample of head~          and neck cancer patients.~        3. To examine the influence of smoking status and body image on quality of life outcomes.~   "
240086|NCT00412477|"~     To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given~     intramuscularly~      To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given~     intramuscularly~   "
240087|NCT00412464|"~     This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use~     in adults (not in children) in a children aged 1-18 years. Subject with a blood clot~     (thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be~     eligible to participate. Subjects will receive a once daily dose of fondaparinux followed by~     blood tests at 2, 4, 12, and 24 hours after the first dose in order to determine the proper~     dose for this age group. The hypothesis is that children receiving fondaparinux will be able~     to receive a once daily dose. The currently available alternative agent, enoxaparin, needs to~     be given twice daily. In addition, an evaluation of the safety of this medication will be~     made by assessing for side effects, especially bleeding.~   "
240088|NCT00412451|"~     A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical~     PVD induction for treatment of patients with DME.~   "
240089|NCT00412438|"~     The atrial fibrillation (AF) is the most common cardiac rhythm disturbance that is~     responsible for substantial morbidity and mortality independent of associated heart disease~     or other risk factors. Even in the absence of preexisting cardiovascular disease, AF remains~     significantly associated with excess mortality rates. The current unsatisfactory treatment~     for AF comes from lack of understanding of the pathophysiology of AF. The purpose of this~     study is to identify gene polymorphisms that confer susceptibility to atrial fibrillation.~     Patients with AF（N=500） and healthy volunteer（N=1000） without AF are enrolled in this study.~     Patients with coronary artery disease, severe valvular heart disease, cardiomyopathy or heart~     failure were excluded from the study.~   "
240090|NCT00412425|"~     Primary Objectives:~        -  Safety of palonosetron administered for control of nausea and vomiting in patients with~          metastatic melanoma receiving biochemotherapy.~        -  To determine the patterns and severity of nausea and vomiting in two groups of patients~          with metastatic melanoma receiving biochemotherapy with palonosetron premedication using~          two schedules of palonosetron administration.~   "
240091|NCT00412412|"~     The goal of this clinical research study is to study the drug CNF2024 as a single agent or in~     combination with trastuzumab in patients with advanced breast cancer and to:~        -  find the highest dose of the drug CNF2024 as a single agent or in combination with~          trastuzumab that can be given safely~        -  measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood~        -  determine if CNF2024 as a single agent or in combination with trastuzumab can stop~          breast cancer cells from growing~   "
240092|NCT00412399|"~     The specific aim of this study is to compare the rate of negative work role events in~     individuals with rheumatoid arthritis compared to healthy controls.~   "
240093|NCT00412386|"~     Bicuspid aortic valve (BAV) is a form of congenital heart disease (the person is born with~     it). With BAV, the heart valves in the aorta (the blood vessel that takes blood away from the~     heart to the body) are not formed right. A person with BAV has only 2 leaflets instead of~     three and the valve leaflets are often thickened. This can result in the block of blood flow~     across the valve (aortic stenosis) and/or valve leakage (aortic valve regurgitation).~      From our experience at least 1/3 of patients with BAV will eventually develop complications.~     Many patients with BAV do not develop significant problems until well into adulthood. The~     most common problem in BAV patients is aortic dilatation and/or dissection. At this point, we~     do not know on who or why aortic dilatation or dissection occurs.It is unclear whether the~     enlargement is because of abnormal blood flow patterns, as a result of the shape of the~     bicuspid valve, or whether it is because the way the aortic valve and/or vessel is formed. In~     other words, the abnormal shape of the aortic valve may cause blood to flow in a different~     way than it normally would, causing damage to the aorta as blood leaves the heart. There may~     be a problem with the way the aortic valve connects to the aorta, which causes the aorta to~     get larger or break down over time. It is also possible that the wall of the aorta in~     patients with BAV is weaker than it would be in patients without BAV. At this point, we do~     not know. It is believed by the investigators that if we can determine why the aorta gets~     larger or tears, we can minimize the effects or prevent them altogether.~      This study will collect blood and cardiac MRI images from forty-five (45) patients at~     Children's Healthcare of Atlanta Egleston. There will be a study group (patients with BAV)~     and a control group of patients (patients scheduled for a cardiac MRI but without BAV).~      All enrolled patients will have blood drawn by nursing staff from a peripheral vein and~     collected in tubes for testing the day of their MRI scan. This test is called a plasma matrix~     metalloproteinase level. It is believed that patients who have bicuspid aortic valves and~     dilated aortas have high plasma levels of this protein. This study will compare the MRI~     images and plasma matrix protein levels of all the patients participating in the study.~   "
240094|NCT00412373|"~     The purpose of this study is to measure the effectiveness and assess the safety of different~     dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER)~     in patients who are experiencing an acute episode of schizoaffective disorder.~   "
240095|NCT00412360|"~     This study is a Phase III, randomized, open-label, multi-center, prospective study of single~     umbilical cord blood (UCB) transplantation versus double UCB transplantation in pediatric~     patients with hematologic malignancies.~   "
240096|NCT00412347|"~     Increasing evidence from clinical studies in Intensive Care Unit (ICU) settings indicates~     that insulin infusion can improve outcome measures for patients with hyperglycemia (high~     blood sugar) independent of a previous diagnosis of diabetes mellitus. This improvement in~     health could also apply to patients that have high blood sugars in various other non-critical~     care areas of the hospital as well. However, the data that shows improvement in health~     outcomes has been collected from wards that have a lower patient to provider and patient to~     nurse ratio, resulting in the ability for a much tighter control of the insulin infusion. We~     hypothesize that tight blood glucose control will provide the same benefits for patients in~     non-intensive care units settings but that these protocols may lead to a higher incidence of~     hypoglycemia (low blood sugar) and potentially to adverse outcomes in patients.~      This study aims to determine the clinical outcome of patients treated with insulin infusion~     as well as the rate of hypoglycemic episodes in non-intensive areas. We will conduct a chart~     review of patients treated with insulin infusions in non-critical wards at Emory University~     Hospital during the period of 7/1/04 to 6/30/05. Medical records of all patients treated with~     intravenous insulin infusion protocols will be analyzed. Data on demographics, laboratory~     values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition~     at discharge will be analyzed.~   "
240097|NCT00412334|"~     This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in~     patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous~     treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one~     of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS~     180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus~     Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus~     1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of~     treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the~     target sample size is 100-500 individuals.~   "
240098|NCT00412321|"~     The purpose of this study is to evaluate of the study of different CNTO 328 doses and~     schedules and to see if CNTO 328 has any effect on Non-hodgkin's Lymphoma, Multiple Myeloma~     or Castleman's disease.~   "
240099|NCT00412308|"~     The study will compare outcomes between individuals with sub-acute, ventilator-dependent~     tetraplegia using high (20 cc/kg) vs. low (10 cc/kg) tidal volumes during mechanical~     ventilator support.~   "
240100|NCT00412295|"~     The purpose of this study is to:~        1. determine the safety of wavefront guided PRK~        2. evaluate the efficacy of wavefront guided PRK~        3. evaluate the differences in visual quality after treatment of wavefront guided PRK~   "
240101|NCT00412269|"~     The purpose of this study is to determine the effect of menopause on obesity, energy balance,~     and insulin in postmenopausal, obese women.~   "
240102|NCT00412256|"~     The primary hypothesis constitutes that the fish-oil preparation (Omegaven) is superior to~     the preparation based on Soja-oil (Lipovenös)to reduce signs and symptoms in patients with~     active rheumatoid arthritis.~   "
240103|NCT00412243|"~     The goal of this clinical research study is to find the highest tolerable dose of the drugs~     clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or~     refractory ALL. The safety of the combination treatment will also be studied.~      Objectives:~      Phase I:~        1. To establish toxicities and safety of the proposed combination~        2. To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the~          combination to proceed with the phase II part of the study~           Phase II:~        3. To establish the efficacy (complete and overall response) of the proposed combination.~        4. To analyze pharmacokinetic (PK) and pharmacodynamic (PD) properties of clofarabine as~          well as the impact on DNA repair of leukemic blasts with the proposed combination.~   "
240104|NCT00412230|"~     The purpose of this study is to determine whether insulin resistance might affect the~     pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers~     of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.~   "
240105|NCT00412217|"~     This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo~     in participants with resected head and neck squamous cell cancer who are receiving concurrent~     chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either~     erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease~     progression or unacceptable toxicity.~   "
240106|NCT00412204|"~     The purpose of this study is to determine the effect of treatment with tiotropium bromide on~     efficiency of gas exchange and exercise performance in COPD subjects during exercise.~   "
240108|NCT00412178|"~     Previously we demonstrated the beneficial effects of an Internet-based glucose-monitoring~     system (IBGMS) in people with type 2 diabetes mellitus. The “Diabetes Phone”, a cellular~     phone with a glucometer integrated in the battery pack, was launched in Korea in 2003. Here~     we test the short-term effectiveness of the diabetes phone for glucose control and compare it~     with that of IBGMS.~   "
240109|NCT00412165|"~     This randomized control study (sponsored by the NIH, NIDDK) is aimed at reducing BMI in~     overweight adolescents at risk for the development of type 2 diabetes. The study will examine~     whether an integrated primary care, web and cell-phone-based intervention can produce initial~     and sustained improvements in anthropometric, behavioral, metabolic, and physiological~     outcomes in overweight adolescents. The primary goal is to reduce BMI (Body Mass Index)in~     overweight adolescents.~   "
240110|NCT00412152|"~     The primary objective of this study is to demonstrate that subjects with moderate to severe~     non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in~     symptoms of constipation compared to subjects taking oxycodone prolonged release tablets~     alone.~   "
240111|NCT00412139|"~     Patients treated by chronic renal replacement therapy are exposed to cardiovascular problems~     and suffer from an accelerated and sever atherosclerosis. Classical risk factors for~     atherosclerosis and cardiovascular diseases (CVD) do not explain the full risk of CVD in the~     dialysis patients. Additional risk factors are therefore likely to exist. The uremic syndrome~     is attributed to the progressive retention of a large number of compounds, which under normal~     conditions are excreted by the healthy kidneys. Uremic toxins such are parathormone (PTH),~     vitamin D and phosphates, cause development of renal osteodystrophy (ROD), i.e. disordered~     calcium and phosphate metabolism. Both conditions of hyperparathyroid and adynamic bone~     disease (ABD) lead to an elevated calcium x phosphate product and increased vascular~     calcification, which might occur in intimal and medial layer of the vessel wall. It is~     important to consider these processes separately, as the vascular consequences (occlusion~     with atheromatosis and vascular stiffening through medial calcification) are different.~     Moreover, the difference between uremic and non-uremic intimal plaque is not the size but its~     composition, with markedly increased calcium content. Hence, these observations have an~     important socio-economic impact because of the increased cardiovascular morbidity and~     mortality.~      The investigators hypothesized that uremic toxins in dialysis patients influence directly~     and/or indirectly the development of atherosclerosis, vascular calcifications and CVD.~   "
240112|NCT00412126|"~     Coronary artery disease is a process that results in “hardening of the arteries”. When the~     arteries that supply blood and oxygen to your heart muscle become clogged or narrowed, a~     heart attack may result, or you may feel chest discomfort (angina) – sometimes even while~     resting. One approach to treating this condition is a balloon procedure known as coronary~     angioplasty.~      The major limitation of coronary angioplasty is renarrowing of the artery (restenosis) in the~     first six months following the procedure requiring either repeat angioplasty or referral for~     bypass surgery. Patients with diabetes have always been identified as having higher rates of~     restenosis and poor outcomes following angioplasty, despite some important scientific~     advances. We think that the level of blood sugar control at the time of angioplasty and in~     the following months may be related to the extent of restenosis.~      We expect that a reduction in blood sugar with insulin may, in turn, reduce the restenosis~     process and improve your long-term outcome.~   "
240113|NCT00412113|"~     The purpose of this study is to investigate whether an aggressive multi-risk factor~     management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in~     greater percentage of patients achieving blood pressure and low density lipoprotein~     cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol~     Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach~     (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with~     hypertension and additional risk factors, including dyslipidemia.~   "
240114|NCT00412100|"~     The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged~     release tablets have improvement in symptoms of constipation compared to subjects taking~     oxycodone prolonged release tablets alone.~   "
240115|NCT00412087|"~     Science News (October 2004) called vitamin D deficiency a silent epidemic in America, with~     no group unaffected. Using new guidelines of optimal vitamin D levels, more than 90% of~     African American women now suffer from vitamin D deficiency. Deficiency during pregnancy has~     profound effects on the developing fetus. Other systems besides bones are affected by vitamin~     D deficiency, including an increased risk of autoimmune diseases such as rheumatoid~     arthritis, multiple sclerosis, type I diabetes, and certain cancers.~      This study proposes to examine and manage vitamin D levels in more than one thousand women in~     an underserved population in South Carolina. The women will be from the patient population~     seeking OB/GYN and Pediatric services through Eau Claire Cooperative Health Centers, Inc.~     (ECCHC), a network of ten clinics in three counties in the center of the state approximately~     70 miles from Charleston, SC. ECCHC is one of approximately 1000 community health centers~     supported through Health and Human Services' (HHS) Health Resources and Services~     Administration's (HRSA), Bureau of Primary Health Care.~      The research objectives for this project will be managed through the Pediatric Nutritional~     Sciences Research Center of the Children's Research Institute at the Medical University of~     South Carolina, Charleston, SC, in collaboration with ECCHC. The research aims will evaluate~     vitamin D levels and possible contributing factors to the levels in pregnant women. Women who~     present to ECCHC within the first trimester of pregnancy will be randomized to one of two~     doses of vitamin D supplementation shown to be effective in other groups. Each pregnant~     mother will begin supplementation during the 12th week of pregnancy and will be followed~     closely throughout pregnancy for one year to determine the effectiveness of supplementation~     on vitamin D status, overall health of mother, and of her infant following delivery.~      We expect to observe severe vitamin D deficiency in a considerable percentage of the mothers~     and their infants who receive care at ECCHC, especially those individuals with darker~     pigmentation. When the extent of vitamin D deficiency within each racial/ethnic group is~     better defined and their supplementation requirements identified, we will be better able to~     establish guidelines for supplementation and health maintenance, and set policy~     recommendations for the dietary recommended intake of vitamin D. Those women and their~     infants identified as deficient in vitamin D will be important in establishing community~     health care policies for vitamin D surveillance and supplementation strategies. The results~     will allow us to implement specific dietary and/or medical interventions aimed at correcting~     hypovitaminosis D in the population in this study and other similar populations being served~     by the more than 1000 community health centers nationally.~   "
240116|NCT00412074|"~     The purpose of this study is to determine the effectiveness and safety of maternal and infant~     vitamin D supplementation as a function of ethnicity and latitude in the prevention of~     vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will~     generate important new information for health care professionals and policy makers with~     regard to vitamin D requirements and the potential benefit to both mother and infant~   "
240117|NCT00412061|"~     The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment~     with depot octreotide prolongs progression free survival compared to treatment with~     octreotide alone in patients with advanced carcinoid tumor.~   "
240118|NCT00412048|"~     The aim of the protocol is to study the resting brain activation profile of 3 groups of~     people, using a new fMRI procedure, called fMRI-SAM. fMRI-SAM will be applied to 25~     Alzheimer's disease (AD) patients, 25 patients suffering from amnestic - mild cognitive~     impairment (MCI) - a clinical picture which may be a prodromal form of AD - and 60 healthy~     controls. The first analysis of the data will search differences of brain activation profiles~     between the 3 groups. In the second step, the investigators will study the predictive value~     of fMRI-SAM to detect MCI patients who will later convert to AD.~   "
240119|NCT00412035|"~     The purpose of this six site multi-center study is to determine if BTX-A can alleviate the~     post-operative pain and improve the functional and quality of life outcomes of children with~     limb length discrepancy or angular deformity undergoing limb lengthening or deformity~     correction.~   "
240120|NCT00412022|"~     The HOBOE study was amended in November 2009, and, after reaching enrollment of the first 500~     patients, the study began recruiting premenopausal patients only. The primary objective of~     the extended study is to compare disease free survival in premenopausal patients with early~     breast cancer. Patients receive triptorelin and are randomized in a 1:1:1 fashion to receive~     tamoxifen or letrozole, or letrozole + zoledronic acid.~      The purpose of the HOBOE study, Version 1, was to compare the adjuvant hormonal therapy~     treatments of Tamoxifen, Letrozole and Letrozole + Zoledronate for their effects on bone loss~     in breast cancer patients. Postmenopausal and premenopausal patients were eligible, the~     latter also receiving monthly triptorelin. Upon reaching the enrollment of the first 500~     patients in March 2010, the study began recruiting premenopausal patients only.~   "
240121|NCT00412009|"~     Tuberculosis (TB) patients who receive inadequate treatment or do not complete therapy are~     more likely to remain infectious, thus contributing to the continuous spread of TB infection~     in communities. Despite the widespread use of Directly Observed Therapy, defaulters remain an~     important problem in TB control programmes. In Sénégal, defaulters rate reach 30%, which is~     hampering dramatically the effectiveness of control. New strategies to deliver treatment to~     TB patients and ensure proper adherence that are adapted to the local situations are urgently~     needed.~      Objectives~      The overall objective of the project is to improve tuberculosis treatment success rates in~     Sénégal. The specific objectives are:~        1. to assess the current situation of tuberculosis (TB) in Sénégal~        2. to identify the determinants of cure,~        3. to develop measures to improve patient’s compliance with the treatment that are adapted~          to the local situation, acceptable, affordable and sustainable~        4. to evaluate the impact of these measures on TB control.~      Methods~      The proposed research seeks to develop and test innovative methods to improve cure rates in~     TB patients. It will explore the factors of success of TB treatment using inter-disciplinary~     approach, integrating social sciences and economic analyses into TB research. The project is~     composed of 3 comprehensive phases:~        -  Phase 1: baseline assessment of the TB situation.~        -  Phase 2: anthropological study, investigating various domains contributing to patients~          cure using a range of qualitative research methods. At the end of this investigation, it~          is expected that determinants of care will be clearly identified. On this basis,~          suitable methods for improving patients’ adherence to treatment will be tailored and~          developed.~        -  Phase 3: these methods will be tested and compared using a cluster randomised controlled~          trial design, in populations served by defined health centres. Their efficacy will be~          measured in terms of improvement of the classical TB control programme indicators (cure~          rate, defaulter rate, failure rate, death rates). The methods will also be evaluated on~          their acceptability by the TB patients and the communities and on their feasibility~          (duration : 24 months).~      Expected results:~      Methods to improve patients’ adherence to treatment that are affordable, acceptable and~     sustainable will be developed and tested according to qualitative and quantitative criteria.~   "
240122|NCT00411996|"~     We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a~     boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK~     profile associated with adequate antiretroviral potency, tolerability and efficacy.~   "
240123|NCT00411983|"~     With HIV/AIDS increasingly considered a chronic disease, 24-, or 48-week data from~     antiretroviral studies are no longer sufficient. Only with long-term follow-up and outcome~     data will shed some much-needed light on the answers of questions that have stumped us for~     several years. Data from a large observational cohort of patients treated with combination~     antiretroviral therapy will provide further insights into the long-term safety and durability~     of various antiretroviral therapeutic approached, the efficacy of HIV viral load and CD4 cell~     counts as predictors of disease progression and mortality, and the importance of adherence.~   "
240124|NCT00411970|"~     The aim of the present study is to compare the functional and clinical differences and~     advantages between a standard operating system and a newly developed even smaller system for~     pars plana vitrectomy.~      The present study may work out the possible advantages and disadvantages between the~     routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.~   "
240125|NCT00411957|"~     Several studies from HIV-NAT have demonstrated high nevirapine, indinavir, saquinavir and~     lopinavir/r levels when compared to Caucasian patients. Until now, the pharmacokinetics of~     atazanavir have not been explored in a Thai population. We postulate that ATV levels, as with~     other PIs, are higher in Thai people. Therefore, the level of ATV in ATV/RTV 300/100 OD may~     be higher than the acceptable range and could be associated with ATV related toxicity.~   "
240126|NCT00411944|"~     An evaluation of the effects of genetically determined variant metabolizing and transporting~     proteins involved in the disposition of the immunosuppressive drug tacrolimus in renal~     transplant recipients. In a five year follow-up study tacrolimus dose-corrected exposure~     changes significantly and the effect(s) of single nucleotide polymorphisms of the~     CYP3A4/CYP3A5 and MDR1 genes on the latter is assessed in this study.~   "
240127|NCT00411931|"~     Compare relative exposure in the younger age group in order to supplement the PK profile~     already determined in older children and adults~   "
240128|NCT00411905|"~     We are evaluating the efficacy of the association of Low dose Cytarabine in association with~     Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes.~     Our aim is to decrease transfusion requirements and if possible induce a complete or at least~     a partial remission.~   "
240129|NCT00411892|"~     This trial is conducted in the United States of America (USA). This trial will compare the~     changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy~     versus pioglitazone treatment alone.~   "
240130|NCT00411879|"~     A randomized controlled trial did not show benefit of vasopressin versus epinephrine in~     inhospital cardiac arrest. Preceding laboratory data suggest that combined vasopressin and~     epinephrine ensure long-term survival and neurologic recovery. Also, postresuscitation~     abnormalities mimic severe sepsis. The investigators hypothesized that combined vasopressin~     and epinephrine during cardiopulmonary resuscitation (CPR), and steroid supplementation~     during and after (when required) CPR may improve survival in cardiac arrest.~   "
240131|NCT00411866|"~     The purposes of this study are to determine if there is a difference in how SB-773812 is~     distributed through the bloodstream before and after multiple doses of ketoconazole have been~     given and to determine if there is a difference in how safe and well tolerated SB-773812 is~     when given on its own and given with ketoconazole.~   "
240132|NCT00411853|"~     We propose in this study to treat hormone refractory prostate cancer (HRPC) patients., with a~     novel preparation of fermented wheat germ nutriment (FWGE), in combination with the 1st line~     hormone therapy, the gonadotropin releasing hormone (GnRH), which stopped being effective.~     The study will be conducted during two years with 60 patients. The efficacy will be assessed~     in terms of clinical and serological response and by specific questionnaires.~      This concept is based on previous reports regarding other diseases such as colon cancer,~     where the addition of a new drug to a drug which previously had failed, improved the~     patients' survival, the quality of life and the clinical parameters. In addition, preclinical~     data have shown activity of that regimen in prostate cancer cell lines and in animals'~     models.~      FWGE exhibits a wide variety of mode of actions, in a wide range of malignant tumors. It~     increased the natural immune responses while decreasing the systemic inflammation often~     present in cancer patients. It reduced the growth of human prostate tumor xenograft in mice~     and prolonged their survival. It delayed disease progression, increased overall survivals,~     improve quality of life and reduce oxidative stress.~      The long-term goal of this research is that the addition of FWGE to a drug which previously~     had failed, would slow down disease progression in patients with advanced and thus refractory~     cancers, improving the patients' quality of life, their clinical parameters and survival.~   "
240133|NCT00411840|"~     We analyze the effects of combined intramuscular and intraarterial transplantation of BMCs in~     patients with PAD. BMCs were transplanted into the ischemic limb.~      After 2 and 13 months walking distance and perfusion indices were monitored.~   "
240134|NCT00411827|"~     Purpose: To develop a screening metric by examining both the characteristics of the~     preoperative tear film and the intracellular signaling pathways of conjunctival goblet cells~     in order to determine if there are certain characteristics which might predict those patients~     who will experience serious dry eye symptoms and complications after refractive surgery.~      Research Design: This study is a twelve-month prospective non-randomized investigation.~      Methodology: In conjunction with psychometric questionnaires and various measures of tear~     film quality (e.g. Schirmer's test, tear break up time, etc), impression cytology will be~     used to assess the intracellular signaling pathways of conjunctival goblet cells and to~     determine if alterations in this pathway exist. Alterations in this pathway would result in a~     reduced response by the mucin secreting conjunctival goblet cells thereby promoting the~     development of dry eye after refractive surgery.~   "
240135|NCT00411814|"~     This is a two part study. Part I is designed to test single doses of GSK678586A in healthy~     volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients~     with mild asthma. Both parts are designed to investigate the safety, tolerability and the way~     the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).~   "
240136|NCT00411801|"~     Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a~     fatal condition. During plasma exchange therapy, patients need transfusion plasma that is~     blood group specific. Transfusing a patient with an incorrect blood group may have fatal~     consequences. Uniplas is a universally applicable human plasma, which can be administered~     irrespective of the patient's blood group. This study will test the safety and efficacy of~     Uniplas in comparison to cryosupernatant plasma in treatment of patients with TTP.~   "
240137|NCT00411788|"~     Rapamune (generic name: Sirolimus®) is a drug that has been approved by the Food and Drug~     Administration (government) for use in patients receiving a kidney transplant to prevent the~     patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the~     laboratory, but has not been approved at this time for the treatment of cancer. Herceptin is~     a new form of chemotherapy that has been approved by the Food and Drug Administration for the~     treatment of breast cancer.~      This study is designed to evaluate the effect and safety of combining Rapamune and Herceptin~     on breast cancer. Rapamune and Herceptin are being combined because results from our~     laboratory studies suggest that the combination of the two drugs is superior to either drug~     used alone. Results from laboratory studies performed at other institutions suggest that~     adding Rapamune to Herceptin may also reverse the resistance to Herceptin. Although there has~     been extensive experience using Herceptin alone and Rapamune alone in human subjects, the~     combination of Herceptin and Rapamune has not been previously evaluated. In addition, we hope~     to better understand how these treatments work against an individual woman's tumor by~     analyzing tissue samples before, and during treatment.~   "
240138|NCT00411762|"~     The aim of this research project is to determine the amount of capecitabine (Xeloda) which~     can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the~     aim of this research project to determine what the effects, good and/or bad, are of combining~     capecitabine (Xeloda) with PHY906 (investigational drug) in the treatment of advanced~     pancreatic cancer.~      PHY906 is a powder from plants sold as a health food supplement in the United States. PHY906~     has been used in China, Taiwan and other Asian countries as traditional Chinese medicine for~     hundreds of years.~      The other drug involved in this study, capecitabine is an oral form of chemotherapy already~     approved by FDA in the management of colorectal and breast cancer.~      Laboratory studies in animal models have shown that the combination of capecitabine and~     PHY906 shrinks liver cancer, and a pilot clinical study is currently evaluating this~     combination in patients with liver cancer to define the benefit. PHY906 has also shown to~     decrease diarrhea related to chemotherapy in a small study performed in patients with colon~     cancer treated at the Yale Cancer Center. Our recent laboratory studies have also shown that~     the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models.~     This prompted us to test the combination of capecitabine and PHY906 in patients with advanced~     pancreatic cancer to assess the benefit in survival as well as any decrease in side effects,~     such as diarrhea caused by capecitabine.~   "
240139|NCT00411749|"~     The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent~     females~   "
240140|NCT00411736|"~     In patients with Cystic Fibrosis, recurrent airway infection caused by Pseudomonas aeruginosa~     ultimately leads to chronic airway infection. The purpose of this study is to determine~     whether supplementary low-dose azithromycin to standard inhaled colistin and oral~     ciprofloxacin in the treatment of intermittent pseudomonas airway-infection can postpone the~     next episode of intermittent pseudomonas airway-infection and prevent development of chronic~     airway-infection.~   "
240141|NCT00411723|"~     RTL1000 is a new agent that has not been previously tested in humans. It is thought that RTL~     may specifically control the abnormal immune response or attack against the insulation on the~     nerves that occurs in multiple sclerosis.~      The purpose of this study is to evaluate the possible side effects of a single intravenous~     dose of RTL1000 in subjects with multiple sclerosis. Some subjects will also be asked to~     participate in one or both of two substudies, one to test blood samples to see how the body's~     immune system responds after administration of RTL1000, and the other to test blood samples~     to see how the body absorbs and eliminates the RTL1000.~   "
240142|NCT00411697|"~     The purpose of this study is to determine at 5 years of age the persistence of immunity to~     hepatitis B that was conferred by infant vaccination with Infanrix hexa™.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
240143|NCT00411684|"~     The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing~     pregnancy when taken 3 to 5 days after unprotected sexual intercourse.~   "
240144|NCT00411671|"~     Primary Objective:~        -  To determine the 8 week progression-free survival rate (i.e. disease control rate) in~          patients with advanced non-small cell lung cancer (NSCLC) who have failed at least one~          prior chemotherapy regimen.~      Secondary Objective:~      The secondary objectives of this study will be to:~        -  Determine the overall response rate~        -  Determine the overall survival~        -  Determine the time to disease progression~        -  Assess the safety/toxicity of the study treatment~        -  Assess biomarker modulation in the tumor tissue and serum samples from the treatment.~        -  Assess plasma and intra-tumor concentrations of study treatment~   "
240145|NCT00411658|"~     Study no longer required~   "
240146|NCT00411645|"~     The purpose of this research study is to investigate whether or not maribavir is safe and~     effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who~     have had a stem cell transplant.~   "
240147|NCT00411632|"~     The goal of this clinical research study is to evaluate the effectiveness of Tarceva®~     (OSI-774, erlotinib hydrochloride) in combination with Targretin® (bexarotene) in treating~     NSCLC. The safety of this treatment will also be studied, as well as the treatment's effect~     on different cells in the body and the participants' overall response.~   "
240148|NCT00411619|"~     The purpose of the study is to evaluate the safety and potential side effects of everolimus~     (an experimental drug) on a person with Tuberous Sclerosis Complex who also has been~     diagnosed with a brain tumor (astrocytoma)~      The hypothesis is that the drug will cause the tumor size to decrease, and may have~     beneficial activity separate from effects on tumors in patients.~   "
240149|NCT00411606|"~     An objective of this study is to standardize temperature values derived from thermograms of~     the facial region. It is anticipated that the mean temperature of a defined region of~     interest, such as the eyes, nose, or sinuses, might be useful for future applications.~      The investigators will attempt to determine normal temperature ranges based on participants'~     age and gender.~   "
240150|NCT00411593|"~     Primary Objective~      The primary objective of this phase I-II study is to evaluate:~        -  Phase I: Assess the maximum tolerated dose (MTD) of bortezomib in a weekly schedule with~          bevacizumab given every 3 weeks.~        -  Phase II: Using the MTD established in phase I, assess efficacy of the combination as~          indicated by progression-free survival.~      Secondary Objectives~      The secondary objectives of this study are to evaluate:~        -  Response rates and duration of response~        -  1 year survival~        -  Overall survival~        -  Qualitative and quantitative toxicity~        -  Circulating endothelial cells (CECs) prior to treatment, prior to cycle 2, and/or at the~          time of progression~   "
240151|NCT00411580|"~     This study will evaluate the safety and tolerability and Aß-specific antibody response of~     CAD106 in patients with mild to moderate Alzheimer's Disease.~      Patients also had a 2 year follow-up to assess disease progression where no drug was~     administered.~   "
240152|NCT00411567|"~     The purpose of this study is to investigate/assess the treatment of moderate to severe~     asthmatics with inhaled corticosteroid.~   "
240153|NCT00411554|"~     The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients~     with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.~   "
240154|NCT00411541|"~     Studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic~     leukemia could be improved by intensification of conventional continuation chemotherapy with~     pulses of vincristine sulfate and steroids. We aimed to investigate the efficacy and toxic~     effects of vincristine-dexamethasone pulses as an addition to the continuation-therapy phase~     in a large cohort of children with intermediate-risk disease who were treated with the BFM~     treatment strategy~   "
240155|NCT00411528|"~     The objective of this study is to assess the response of patupilone plus prednisone compared~     to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic~     hormone refractory prostate cancer. Additionally, this study will assess the response on~     measureable disease and the effects on patient-reported outcomes.~   "
240156|NCT00411515|"~     The purpose of this prospectively randomized multicentre study was to prove the efficacy and~     safety of mycophenolate mofetil (MMF) to preventing graft rejection and improvement of clear~     graft survival following high-risk keratoplasty.~      The patients of the MMF group receive MMF orally 2x1 g daily for 6 months. Endpoints were~     immune reaction free and clear graft survival and the occurence of side-effects.~   "
240157|NCT00411489|"~     The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in~     the United States. Despite initial weight loss, some patients experience weight regain that~     may be related to an increase in the size of the gastric pouch and/or stoma. A second~     surgical procedure to reduce the size of the pouch and/or stoma is typically associated with~     a higher risk of death or complications than the original gastric bypass procedure. This~     study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a~     means of producing weight loss in patients who have regained weight following gastric bypass.~   "
240175|NCT00411242|"~     This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50~     mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week~     double-blind phase and a 52-week open-label phase.~   "
240158|NCT00411463|"~     Purpose of this study is to examine the effectiveness of an experimental psychotherapy (talk~     therapy) for the treatment of bipolar II depression. The name of this psychotherapy is~     Interpersonal and Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). Subjects will~     be randomly assigned to receive either IPSRT-BPII or the medication Seroquel (quetiapine) to~     manage their symptoms of bipolar II depression. Subjects will receive the assigned therapy~     for up to 20 weeks.~   "
240159|NCT00411450|"~     The primary objective is to estimate the effect of the human homolog of the Kirsten rat~     sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue~     on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving~     second-line chemotherapy with panitumumab after failing first-line treatment.~   "
240160|NCT00411437|"~     The primary purpose of the trial is to show that tolterodine ER has no effect on memory and~     other cognitive abilities in an elderly population~   "
240161|NCT00411424|"~     The purpose of this study is to investigate the safety and tolerability of the new medication~     ASK8007, and to study whether it has a beneficial effect on joint inflammation in patients~     with rheumatoid arthritis.~   "
240162|NCT00411411|"~     We wish to evaluate the effect of long term treatment with a DPP-IV inhibitor on the function~     of the incretin hormones~      Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by~     DPP-IV inhibitor (Januvia®) treatment significantly ameliorates the impaired secretion and~     potency of GLP-1 and leads to a restoration of the lost action of GIP.~   "
240163|NCT00411398|"~     This study is being conducted to evaluate the safety and effectiveness of memantine Add-On~     treatment of patients who are currently taking an SNRI or SSRI and who remain anxious and~     symptomatic despite treatment.~      Secondary objectives of this study are:~      •-to evaluate if there is an improvement in disability levels following memantine dosing~      -to evaluate if there is an improvement in sleep quality following memantine dosing~   "
240164|NCT00411385|"~     This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of~     albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon~     alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic~     hepatitis C, genotype 2/3 who are IFNa treatment naive.~   "
240165|NCT00411372|"~     This study will last for approximately 8 weeks and will involve 4 visits. The study is being~     carried out to validate a shortness of breath questionnaire~   "
240166|NCT00411359|"~     The purpose of this study is to determine whether cardiac rehabilitation is a successful~     treatment for refractory angina, in relation to improvements in cardiovascular risk factors,~     physical ability, symptomology, quality of life and psychological morbidity.~   "
240167|NCT00411346|"~     The objective of this study was to investigate if a nurse-led telemonitoring programme is~     effective and cost-effective in asthmatic outpatients, aged seven years and older.~   "
240168|NCT00411333|"~     The retinal vasculature changes dramatically in patients with diabetic retinopathy especially~     between non-proliferative and proliferative disease. The retinal vasculature can be imaged~     and quantified using special dyes. This study will test whether the pattern of the retinal~     vasculature changes in patients with different levels of diabetic retinopathy can be~     quantified using computerized image analysis. In addition, the study will evaluate whether~     new drugs to treat diabetic retinopathy will be able to reverse these vascular changes.~   "
240169|NCT00411320|"~     Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The~     causes of this phenomenon are currently unknown. The investigators will perform a number of~     blood & breathing tests to try to discover the cause/s behind this phenomenon with the aim of~     producing leads for further investigation and possible new treatments for smokers with~     asthma.~   "
240170|NCT00411307|"~     The purpose of this small study was to investigate the safety and effectiveness of OROS~     hydromorphone HCI for the treatment of short-term, moderate to severe postoperative pain~     following total knee replacement surgery.~   "
240171|NCT00411294|"~     To examine the effect of ergocalciferol treatment on 25-hydroxyvitamin D and PTH levels in~     patients with CKD stage 3 and 4~   "
240172|NCT00411281|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the~     growth of abnormal cells, either by killing the cells or by stopping them from dividing.~     Giving low-doses of cytarabine may be an effective treatment for Down syndrome and transient~     myeloproliferative disorder. Sometimes the disease may not need treatment until it~     progresses. In this case, observation may be sufficient.~      PURPOSE: This phase III trial is studying low-dose cytarabine to see how well it works in~     treating infants with Down syndrome and transient myeloproliferative disorder.~   "
240173|NCT00411268|"~     The purpose of this open-label, extension study is to characterize the safety, effectiveness,~     and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone~     slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.~   "
240174|NCT00411255|"~     This research study will examine whether magnetic or electrical stimulation of the brain can~     improve the involuntary closure of the eyelids in patients with blepharospasm or Meige~     syndrome; conditions that belong to a group of neurological disorders called dystonias.~     Blepharospasm and Meige syndrome cause excessive involuntary closure of the eyelids or~     blinking. In an earlier study of patients with writer's cramp, which is another form of~     dystonia, symptoms improved temporarily with brain stimulation.~      Interested people 18 years of age or older with blepharospasm or Meige syndrome may be~     eligible for this study. Candidates are screened with a medical history, physical examination~     and a blink reflex test.~      Participants undergo brain stimulation and evaluations before and after the stimulation to~     test the response, as follows:~      Procedures~        -  Transcranial magnetic stimulation (TMS): A wire coil is held on the patient's scalp. A~          brief electrical current is passed through the coil, creating a magnetic pulse that~          stimulates the brain. The subject hears a click and may feel a pulling sensation on the~          skin under the coil. There may be a twitch in the muscles of the face, arm or leg. The~          subject may be asked to tense certain muscles slightly or perform other simple actions.~          The effect of TMS on the muscles is detected with small metal disk electrodes taped to~          the skin of the arms or legs. TMS is done on eight of the ten test days.~        -  Repetitive TMS (rTMS): The same procedure as TMS, except repeated magnetic pulses are~          delivered in short bursts. RTMS is done on eight of the ten test days.~        -  Theta burst stimulation (TBS): A form of rTMS that involves short bursts of impulses.~          TBS is done on four study days.~        -  Cathodal transcranial DC stimulation (tDCS): Two conductive-rubber electrodes placed in~          saline-soaked sponges are positioned over two areas of the head. A constant weak~          electrical current flow is applied for 20 minutes. tDCS is done on two study days.~      Evaluations~        -  Physician observation: The subject's eyes are videotaped for 5 minutes before and after~          each TMS session. A physician then counts how many times the subject blinked during the~          5 minutes.~        -  Questionnaire: Subjects are asked to rate their symptoms before and after brain~          stimulation.~        -  Electrophysiological test of the blink reflex: Wires are taped to the skin on the nose~          and temple to record the eye movement during blinking. A thin plastic rod is placed on~          the skin over the right e...~   "
240176|NCT00411229|"~     Primary:~        -  To demonstrate that capecitabine/oxaliplatin as adjuvant chemotherapy is superior to~          observation alone in terms of 3 year disease-free survival (DFS) rate in~          chemotherapy-naïve patients who underwent potentially curative resection for gastric~          cancer.~      Secondary:~        -  To compare the overall survival of surgery and capecitabine/ oxaliplatin as adjuvant~          therapy versus surgery alone. To evaluate the safety profile of capecitabine/oxaliplatin~          adjuvant therapy.~   "
240177|NCT00411216|"~     The purpose of this study is to determine whether exercises relieve the symptoms of dizziness~     and imbalance in people with vestibular deficits and improves the ability to see clearly~     during head movements. We hypothesize that the performance of specific adaptation and~     substitution exercises will result in an improvement in visual acuity during head movements~     while those patients performing placebo exercises will show no improvement.~   "
240178|NCT00411203|"~     Objective: Evidence indicates that the protein kinase C-PKC signaling cascade may be one of~     the direct targets in treatment of mania. The aim of this study is to investigate whether the~     PKC inhibitor-tamoxifen has anti-manic properties. Method: Bipolar subjects with manic/mixed~     episode were randomly assigned to receive either tamoxifen (80mg/day) or identical placebo~     tablets in 1:1 ratio for three weeks.~   "
240179|NCT00411190|"~     Relacatib is being developed for the treatment of osteoporosis, osteoarthritis and possibly~     other bone disorders. Recent results suggest that relacatib interacts with the way our bodies~     metabolise drugs and so some drugs which are commonly prescribed to the intended target~     patient population could be affected by giving relacatib at the same time. The purpose of~     this study is to evaluate the effect of repeat dose administration of relacatib on the way~     subjects bodies metabolise three commonly prescribed medications in the osteoarthritis~     population: ibuprofen, acetaminophen, and atorvastatin.~   "
240180|NCT00411177|"~     This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and~     high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and~     laboratory parameters, and required medications.~      The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration~     may provide better outcome, less morbidity, higher quality of life, and lesser requirement of~     medications.~   "
240181|NCT00411164|"~     The purpose of this study was to compare the analgesic (a drug that relieves pain)~     effectiveness and safety of OROS hydromorphone HCI (slow release) 8 mg and 16 mg to placebo~     (no drug) in patients with osteoarthritis (OA).~   "
240182|NCT00411151|"~     This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib~     (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer. Despite~     the efforts in front-line therapy, second-line protocols have not yet been established in~     randomized clinical trials for those patients. Although many patients are still in good~     performance status and present with low tumor burden after failure of first-line~     chemotherapy, they may clearly benefit from second-line treatment. Increasingly more~     metachronic metastatic patients are urging for new platinum-free therapeutic options due to~     the fast-growing use of (neo-) adjuvant platin-based protocols.~      So far, only sparse data on chemotherapy are available after failure of platin-based~     protocols. Nearly only irinotecan-containing combinations have properly been analyzed, and~     produced excellent response rates and survival times of up to 30% and 7.6 months,~     respectively. However, irinotecan has not been approved yet for this indication. In addition,~     as irinotecan-containing regimens have been submitted for approval for first-line therapy,~     second-line regimens in irinotecan-refractory patients have not been evaluated in any trial.~     Thus, there is an urgent need to establish new second-line treatment options for both,~     cisplatinum- or irinotecan-combination refractory patients with advanced or metastatic~     gastric cancer.~      Sunitinib inhibits the receptor tyrosine kinases (RTKs) involved in tumor proliferation and~     angiogenesis, specifically the VEGFR, PDGFR, KIT, FLT-3, and RET. The VEGF pathway has been~     shown to be a significant factor in metastatic gastric cancer. In gastric carcinoma cells,~     VEGF ligands and its receptors are definitely involved in the process of tumor progression.~     KDR and FLT-1 are expressed widely and VEGF stimulated KDR-positive tumor cell growth~     directly. The ligand VEGF-C has also been shown to be involved in progression of human~     gastric carcinoma, particularly via lymphangiogenesis. In addition, peritoneal metastases of~     some cancers such as gastric cancers were largely dependent on VEGF. Therefore, patients with~     chemo-refractory metastatic gastric cancer might benefit from VEGFR inhibitory therapy with~     sunitinib.~   "
240183|NCT00411138|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain~     after surgery. It is not yet known whether giving chemotherapy together with radiation~     therapy is more effective than giving radiation therapy alone in treating endometrial cancer.~      PURPOSE: This randomized phase III trial is studying chemotherapy and radiation therapy to~     see how well they work compared with radiation therapy alone in treating patients with~     high-risk, stage I, stage II, or stage III endometrial cancer.~   "
240184|NCT00411125|"~     This is a phase I study to analyze bioavailability and pharmacodynamic of two different~     variants of oral salmon calcitonin (SMC021) in postmenopausal women~   "
240185|NCT00411112|"~     More than 20% of patients operated on for colon cancer without node metastasis will develop~     visceral metastases. The purpose of the study is to determine sentinel lymph nodes with two~     methods: blue injection and isotopic detection. Sentinel nodes will then be analyzed by~     immunohistochemy to detect micrometastases. No adjuvant therapy will be proposed to the~     patient if there are only node's micrometastases and survival will be analyzed in regard to~     the presence of these micrometastasis.~   "
240186|NCT00411099|"~     This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50~     mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week~     double-blind phase and a 52-week open-label phase.~   "
240187|NCT00411086|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such~     as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood.~     Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell~     lymphoma.~      PURPOSE: This phase II trial is studying the side effects and how well giving rituximab~     together with GM-CSF works in treating patients with newly diagnosed follicular B-cell~     lymphoma.~   "
240188|NCT00411073|"~     This is a study to assess the effects of darapladib on the cardiac conduction of the heart as~     compared to placebo and moxifloxacin. This a four period crossover design with each period~     lasting about 10 days. There will be a 7 to 10 day wash out in between each period.~   "
240276|NCT00409903|"~     We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan~     reduces the activity of the sympathetic nervous system in healthy individuals - during~     baseline conditions and after activation of the sympathetic nervous system.~   "
240189|NCT00411060|"~     Data involving orthopaedic conditions and rehabilitation aspects of musculoskeletal and~     neuromuscular disorders will be collected and stored as part of the normal clinical care of~     patients seen in the University of Florida (UF) and Shands Orthopaedics and Sports Medicine~     Institute.~   "
240190|NCT00411047|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with~     previously untreated stage IIIB or stage IV non-small cell lung cancer.~   "
240191|NCT00411034|"~     The purpose of this repeated dose study is to develop recommended dosing information for~     initiation of therapy with OROS Hydromorphone HCI (slow release) in patients with chronic~     cancer pain converting from other strong oral or transdermal opioids. It will also assist in~     the development of a recommended starting dose by which patients can be titrated to an~     appropriate maintenance dose of OROS hydromorphone HCI (slow release). The safety profile for~     OROS Hydromorphone HCI (slow release) will also be evaluated.~   "
240192|NCT00411021|"~     A prospective cross-over randomized study aimed to test the hypothesis that local injury of~     the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients~     will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch~     on days 8-10 and 21-23 of their cycle, preceding the IVF treatment. If not pregnant, the~     women will continue for another IVF cycle, preceded by endometrial or cervical scratch~     complimentary to their procedure in the first cycle. The main major outcomes will include~     pregnancy rate, implantation rate, endometrial thickness, abortion rate, live births and~     embryo quality.~   "
240193|NCT00410995|"~     The purpose of this study is to determine the effect of daily use of Naproxen (a commonly~     used over-the-counter NSAID) on the physical performance of athletes, as measured by maximum~     oxygen consumption.~   "
240194|NCT00410982|"~     The goal of this clinical research study is to find the highest tolerated dose of gemcitabine~     that can be given with busulfan and melphalan. The safety of this drug combination will also~     be studied.~   "
240195|NCT00410969|"~     The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System~     is able to quickly and conveniently cool patients who are comatose after resuscitation from~     cardiac arrest.~   "
240196|NCT00410956|"~     RATIONALE: Drugs used in chemotherapy, such as floxuridine and dexamethasone, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy directly~     into the arteries around the tumor together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving floxuridine and dexamethasone as a~     hepatic arterial infusion together with bevacizumab works in treating patients with~     unresectable primary liver cancer.~   "
240197|NCT00410943|"~     The purpose of this study was to characterize a safe and effective means of conversion and~     titration to an appropriate dose of hydromorphone HCI, to demonstrate comparable efficacy of~     OROS hydromorphone HCI SR (slow release) and hydromorphone HCI IR (immediate release)~     following administration of approximately equivalent total daily doses and demonstrate a~     significant dose-response relationship between OROS hydromorphone HCI SR (slow release) for~     breakthrough pain medication use or alternatively, diary-based analgesic scores~   "
240198|NCT00410930|"~     To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet~     v1 and birch pollen licenced extract used for subcutaneous immunotherapy.~   "
240199|NCT00410904|"~     This phase II trial is studying how well giving AZD2171 together with pemetrexed disodium~     works in treating patients with relapsed non-small cell lung cancer. AZD2171 and pemetrexed~     disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. AZD2171 may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Giving AZD2171 together with pemetrexed disodium may kill more tumor cells.~   "
240200|NCT00410891|"~     Evaluation of efficacy of topical preoperative antibiotics in patients undergoing~     intravitreous injections.~   "
240201|NCT00410878|"~     The purpose of this study was to characterize the steady-state pharmacokinetic (metabolism~     and action) profile of OROS hydromorphone HCI (slow release) in patients who required opioid~     therapy on a daily basis for chronic pain conditions. Patients stabilized on prior opioids~     were converted to OROS hydromorphone slow release and titrated (slowly increased or~     decreased) to adequate analgesia (pain relief). They were maintained at that dose for 4-10~     days and had blood samples drawn over 24 hours on the last day of study.~   "
240202|NCT00410865|"~     Primary Objectives:~        1. To determine the maximum tolerated dose and transduction efficiency of adenoviral~          mediated wild type p53 gene transfer in premalignancies of the upper aerodigestive~          tract.~        2. To determine the efficacy of single agent adenoviral mediated wild type p53 gene~          transfer in reversing oral premalignancies.~   "
240203|NCT00410852|"~     To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients~     (MICU).~   "
240204|NCT00410839|"~     An alpha-linolenic acid (ALA) rich diet in the Lyon Heart Study reduced sudden cardiac deaths~     possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994). Since~     then, there has been a growing interest in ALA as a cardioprotective nutrient. Much of the~     interest has focused on the potential antiarrhythmic effect of ω-3 fatty acids, especially~     the longer chain ω-3 fatty acids, DHA and EPA, derived from fish. We therefore concluded it~     important to test whether the shorter chain ω-3 vegetable oil ALA also had antiarrhythmic~     effects, since this might also explain the beneficial effects seen on cardiovascular~     mortality in the Lyon Heart Study.~   "
240273|NCT00409942|"~     Torasemide is a loop diuretic (pyridine-sulfonylurea)with a wide experience in the treatment~     of oedema associated to heart failure, kidney or liver disease and either in the treatment of~     arterial hypertension (alone or combined with other anti-hypertensive drugs). It has been~     developed a new formulation of Torasemide (Torasemide prolonged release).~      The aim of this trial is to study the effects of Torasemide prolonged released in comparison~     with furosemide, in the reduction of myocardial fibrosis in patients with chronic heart~     failure (Class II-IV of the New York Heart Association Classification.~   "
240205|NCT00410826|"~     This randomized phase II trial is studying cisplatin and radiation therapy together with or~     without erlotinib hydrochloride to compare how well they work in treating patients with stage~     III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Specialized radiation therapy that delivers a high dose of radiation~     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.~     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It may also make tumor cells more sensitive to radiation therapy.~     Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more~     tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective~     with or without erlotinib hydrochloride in treating head and neck cancer~   "
240206|NCT00410813|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to~     compare how well they work in treating patients with stage IV breast cancer that has spread~     to the bone.~   "
240207|NCT00410800|"~     The Pima Indians have the highest reported prevalence of NIDDM of any population in the~     world. Within this population, it is possible to identify subgroups of individuals at a~     particularly high risk for NIDDM. This project examines whether defects in insulin secretion~     contribute to the higher risk of NIDDM in these subgroups and whether they progress over the~     course of the disease.~      Healthy Pima men and women at high risk for NIDDM including individuals in the following 3~     groups will be recruited: 1)persons whose mothers and/or father developed diabetes at an~     early age (< 35 y); 2) persons whose mothers were diabetic during pregnancy; and 3) persons~     whose birthweight was < 2500 g. These individuals, as well as subjects with none of the above~     risk factors and a group of non-Pima controls, will be admitted to the NIH Clinical Research~     Unit at Phoenix Indian Medical Center for the following series of studies. Body composition~     will be determined by DXA scanning and by measuring the amount os visceral abdominal fat~     using MRI. A 75-g oral glucose tolerance test and a 25-g intravenous glucose tolerance test~     will be performed. Insulin action will be measured with a hyperinsulinemic-euglycemic glucose~     clamp (insulin infusion: 40mU/m(2) min and insulin secretory responses to glucose will be~     measured during a 5-step hyperglycemic glucose clamp immediately thereafter. Pima subjects~     will be followed longitudinally after discharge from the unit and oral glucose tolerance~     tests will be performed every three months. Individuals who transition from normal to~     impaired glucose tolerance or impaired glucose tolerance to diabetic will be invited back to~     the Clinical Research Center for repeat testing.~      By comparing insulin secretion-glucose dose-response curves, it may be possible to discern~     subtle defects in insulin secretion predisposing certain individuals to NIDDM. In addition,~     comparison of the responses in the offspring of diabetic pregnancies with those in the~     offspring of mothers who subsequently became diabetic may allow us to separate defects due to~     genetic causes from those due to the intrauterine environment. Finally, studying subjects as~     they progress from normal glucose tolerance to diabetes will test whether the defects in~     insulin secretion are progressive and contribute to the development of NIDDM.~   "
240208|NCT00410787|"~     The primary purpose of this study was to characterize the pain control achieved with~     long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic~     cancer pain and the secondary purpose was to characterize the effects of pain on the~     patients' quality of life with long-term, repeated dosing of OROS hydromorphone (slow~     release) taken by patients with chronic cancer pain.~   "
240209|NCT00410774|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of~     pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine and bevacizumab~     after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase I/II trial is studying the side effects of gemcitabine and bevacizumab~     and to see how well they work in treating patients with pancreatic cancer that has been~     completely removed by surgery.~   "
240210|NCT00410761|"~     The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer~     patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body,~     about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.~   "
240211|NCT00410748|"~     The purpose of study was to characterize the safety and tolerability of long-term repeated~     dosing of OROS hydromorphone controlled release tablets (8,16,32, and 64 mg) in patients with~     chronic cancer pain or chronic non-malignant pain.~   "
240212|NCT00410735|"~     To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a~     double-blind, randomized, placebo-controlled, parallel group, multi-center study~   "
240213|NCT00410722|"~     To determine if tree nuts (Almonds, Hazelnuts, Pistachios, Peanuts, Macadamia nuts, Pecans,~     Walnuts and Cashews) improve glycemic control in type 2 diabetes, as assessed by HbA1c and~     serum fructosamine, and to assess whether these outcomes relate to improvements in~     cardiovascular health (i.e. plasma lipids and measures of oxidative stress, inflammatory~     biomarkers and nitric oxide generation). The investigators have found that nuts tend to~     reduce the glycemic index of bread and have little effect of raising blood glucose on their~     own. Therefore the investigators believe that they would be ideal foods to displace high~     glycemic foods from the diet and lower the dietary glycemic load. This will result in~     improved blood glucose control in type 2 diabetes, with additional benefits on coronary heart~     disease risk factors due to other effects of nuts.~   "
240214|NCT00410709|"~     This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an~     investigational treatment for head lice and nits, in normal, healthy infants.~   "
240215|NCT00410696|"~     The primary objective of the study is to evaluate the efficacy and the safety of~     pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral~     stem cell reinfusion.~   "
240216|NCT00410683|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation~     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known~     whether giving radiation therapy after surgery is more effective than no radiation therapy in~     treating patients with non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared to no radiation therapy in treating patients with non-small cell lung cancer~     that has been completely removed by surgery.~   "
240274|NCT00409929|"~     This study will evaluate the safety and tolerability of ascending single oral doses greater~     than 500 mg of AEB071 in healthy subjects~   "
240275|NCT00409916|"~     The purpose of this study is to determine whether outpatient therapeutic management guided by~     impedance cardiography (ICG), in addition to standard clinical assessment, will result in a~     longer time in days to the first heart failure hospitalization than therapy guided by~     clinical assessment alone.~   "
240217|NCT00410670|"~     This pilot study, conducted by the National Cancer Institute and the Massachusetts General~     Hospital, will investigate genetic factors that contribute to the development of chordoma in~     people from some families. Chordoma is a very rare, potentially fatal, slow-growing bone~     tumor derived from remnants of embryonic material. This study will determine the feasibility~     of conducting a larger study aimed at identifying new families with multiple members affected~     by chordoma to study the genetic basis of the disease.~      English-speaking persons diagnosed with chordoma when they were 18 years of age or younger~     and who were treated at the Massachusetts General Hospital Department of Radiation Oncology~     between 1988 and the end of the study period may be eligible for this protocol. The age range~     of these patients is currently from about 5 months to 33 years.~      Patients (or parents of minor patients) will be mailed a packet with instructions for~     completing the following procedures at home:~        -  Provide permission for researchers to obtain medical records relating to the patient's~          chordoma and any other serious medical conditions he or she has had, and to obtain a~          piece of the patient's stored tumor tissue.~        -  Complete a questionnaire about the patient's close blood relatives, including parents,~          brothers, sisters, and any more distant relatives who have had chordoma or a cancer or~          tumor which started in the brain or spine. The questionnaire will also include~          demographic information, such as education, marital status, ethnicity, religion, and~          household income.~        -  Collect two samples of cheek cells (only from patients 6 years and older). Patients'~          packets include instructions and materials for collecting the cells. Parents of children~          6 to 9 years old will collect cells from the child's mouth using a sterile soft-bristled~          brush contained in a tube. They will brush the inside of the child's cheek with the~          brush for about 30 seconds and then place the brush back in the tube. They will repeat~          this procedure with a second brush. Patients 10 years of age and older will rinse their~          mouth for about 45 seconds with a mouthwash provided in their packets and then spit the~          mouthwash into a collection container. They will repeat the procedure several hours~          later.~      All participants will return the signed permission forms, questionnaires, and cheek cell~     samples to the researchers in a pre-addressed stamped envelope, which is also provided in the~     packet.~   "
240218|NCT00410657|"~     RATIONALE: Alemtuzumab and glucocorticoids, such as prednisone or methylprednisolone, may be~     an effective treatment for acute graft-versus-host disease caused by a donor stem cell~     transplant.~      PURPOSE: This phase II trial is studying how well giving alemtuzumab together with~     glucocorticoids works in treating newly diagnosed acute graft-versus-host disease in patients~     who have undergone donor stem cell transplant.~   "
240219|NCT00410644|"~     The purpose of this repeated dose study is to develop recommended dosing information for~     initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain~     converting from other strong oral or transdermal opioids. It will also assist in the~     development of a recommended starting dose by which patients can be titrated to an~     appropriate maintenance dose of OROS Hydromorphone HCI. The safety profile for OROS~     Hydromorphone HCI will also be evaluated.~   "
240220|NCT00410631|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving combination~     chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill~     tumor cells. An autologous stem cell transplant may be able to replace blood-forming cells~     that were destroyed by chemotherapy and radiation therapy. This may allow more chemotherapy~     to be given so that more tumor cells are killed. Sometimes, after surgery, the tumor may not~     need more treatment until it progresses. In this case, observation may be sufficient. It is~     not yet known whether observation is more effective than combination chemotherapy, radiation~     therapy, and/or autologous stem cell transplant in treating neuroblastoma.~      PURPOSE: This randomized phase III and phase IV trial is studying observation, combination~     chemotherapy, radiation therapy, and/or autologous stem cell transplant to compare how well~     they work in treating young patients with neuroblastoma.~   "
240221|NCT00410618|"~     RATIONALE: Learning about the long-term effects of chemotherapy and radiation therapy on~     brain function may help doctors plan cancer treatments.~      PURPOSE: This clinical trial is looking at the neurological effects of chemotherapy and~     radiation therapy in patients with colon cancer.~   "
240222|NCT00410605|"~     This phase II trial is studying how well giving bevacizumab together with lenalidomide and~     dexamethasone works in treating patients with relapsed or refractory stage II or stage III~     multiple myeloma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Bevacizumab and~     lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer.~     Dexamethasone may stimulate the immune system in different ways and stop cancer cells from~     growing. Giving bevacizumab together with lenalidomide and dexamethasone may kill more cancer~     cells.~   "
240223|NCT00410592|"~     This study will be conducted in order to determine safety and efficacy esomeprazole,~     lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and~     women of Hispanic origin who have GERD.~   "
240224|NCT00410579|"~     RATIONALE: Learning about quality of life, symptoms, and health behaviors in colorectal~     cancer survivors may help to determine the long-term effects of colon and rectal cancer~     treatments and may help to improve the quality of life for future cancer survivors.~      PURPOSE: This clinical trial is looking at patient-reported outcomes in long-term survivors~     of colon and rectal cancers.~   "
240225|NCT00410566|"~     The purpose of this study is to determine the safe range of single doses of rhASM~     administered to adults with ASM deficiency.~   "
240226|NCT00410553|"~     This phase I trial is studying the side effects and best dose of eribulin mesylate and~     gemcitabine hydrochloride in treating patients with metastatic or unresectable solid tumors.~     Drugs used in chemotherapy, such as eribulin mesylate and gemcitabine hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~   "
240227|NCT00410540|"~     The purpose of this study was to demonstrate the clinical equivalence of hydromorphone and~     morphine (immediate-release [IR] and sustained-release [SR] formulations) using the worst~     pain in the past 24 hours item of the Brief Pain Inventory (BPI). The secondary objective of~     this study was to compare hydromorphone and morphine in the following variables: other pain~     measures, various questionnaires, and safety and tolerability variables.~   "
240267|NCT00410020|"~     An alpha linolenic acid (ALA) rich diet in the Lyon Diet Heart Study reduced sudden cardiac~     deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994).~      Since then, there has been a growing interest in ALA, ω-3 fatty acid family precursor, as a~     cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic~     effect of longer chain ω-3 fatty acids, DHA and EPA, derived from fish.~      We therefore concluded it important to test wether vegetable source ω-3 also had~     antiarrhythmic effects, as shown in animals by Leaf and McLennan, since this might also~     explain the beneficial effects seen on cardiovascular mortality in the Lyon Diet Heart Study.~   "
240228|NCT00410527|"~     This study will compare two treatment strategies (standard versus short-course antibiotic~     therapy) for preventing resistant bacterial infection in patients in the intensive care unit~     (ICU). ICUs are the most frequently identified source of hospital-acquired infections. This~     study will examine the effectiveness of 3 days of antibiotic treatment in reducing the risk~     of developing antimicrobial-resistant bacteria as compared with standard antibiotic therapy~     of at least 8 days. It will also determine whether short-course therapy can reduce the~     duration and costs of ICU and hospital stays, of antibiotic treatment, and of costs involving~     treatment of infection-related problems.~      Patients of participating institutions who are in the ICU may be eligible for this study.~     Candidates must be 18 years of age or older. They must have been in the hospital for at least~     3 days, developed new pulmonary infiltrates (fluid or cells in the airspaces of the lungs)~     during their ICU stay and must be at low risk of having pneumonia.~      Participants on short-course therapy take antibiotic for 3 days; those receiving standard~     therapy take antibiotic for at least 8 days. Both groups receive the treatment intravenously~     (through a vein). Sputum specimens are collected at baseline (before starting therapy) and on~     days 3, 10, and 28. Throat culture specimens are obtained at baseline and on days 3, 10, and~     28. Nasal and anal or stool samples are collected at baseline and on days 10 and 28. Cultures~     of respiratory specimens obtained throughout the study period are examined for evidence of~     antimicrobial-resistant bacteria or the isolation of a potential pathogen. All patients are~     followed for 28 days after enrollment or until discharge from the hospital.~   "
240229|NCT00410514|"~     This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to~     placebo.~   "
240230|NCT00410501|"~     This study will evaluate the interaction potential between indacaterol and ketoconazole (a~     potent CYP3A inhibitor) in healthy adult subjects.~   "
240231|NCT00410488|"~     The goal of this clinical research study is to compare 2 treatment schedules of Aloxi~     (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and~     ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron~     on patients' quality of life (QOL) will also be studied.~   "
240232|NCT00410475|"~     Researchers at the National Cancer Institute and the University of Minnesota have followed a~     nationwide cohort of 146,022 radiologic technologists since 1982 (Boice 1992; Doody 1998;~     Mohan 2003; Sigurdson 2003). This is one of the largest cohorts of medical radiation workers~     studied to date (Yoshinaga 2003)and the only one with substantial numbers of women (73%~     female), extensive covariate data, both incident and death outcomes, and estimated~     occupational radiation doses. The overall study objectives are to: quantify radiation~     dose-response for cancers of the breast, thyroid, and other radiogenic sites; assess cancer~     risks associated with genotypic, phenotypic, or other biologically measurable factors; and~     determine if genetic variation modifies radiation-related cancer risks.~      More than 110,000 technologists completed at least one of three comprehensive questionnaire~     surveys administered over the last 20 years and 18,500 are deceased. The First Survey was~     mailed during 1984-1989 to 132,454 known living radiologic technologists, of whom 90,305~     (68%) completed the survey (Boice 1992). The Second Survey was mailed during 1993-1998 to~     126,628 known living technologists, of whom 90,972 (72%) completed the questionnaire~     (Sigurdson2003). Both surveys included detailed questions about employment as a radiologic~     technologist, family history of cancer, reproductive history, height, weight, other cancer~     risk factors (such as alcohol and tobacco use), history of personal diagnostic and~     therapeutic medical radiation procedures, and information on cancer and other health~     outcomes. A third follow-up of this cohort was recently completed. During 2003-2005, the~     Third Survey was mailed or administered by telephone to 101,694 living cohort members who had~     completed at least one of the two previous surveys; 73,838 technologists (73%) completed the~     survey. This questionnaire elicited information on medical outcomes to assess~     radiation-related risks, detailed calendar-specific employment data to refine the~     occupational ionizing radiation dose estimates, and behavioral and residential histories for~     estimating lifetime ultraviolet (UV) radiation exposures.~      The large number of women with estimates of cumulative radiation dose to specific organs~     (e.g. breast) (Simon 2006; see Figure 7 and Table 9) offers at are opportunity to study~     effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive~     organ sites for radiation carcinogenesis in women.. We are not aware of any other study~     population in which both quantified radiation doses and biospecimens are available for~     individuals with protracted low-dose ionizing radiation exposures. Incorporation of~     assessment of the role of genetic polymorphisms and molecular variants in DNA repair and~     other genetic pathways that may be functionally important in radiation carcinogenesis would~     provide initial results on the possible role of genetic factors in the cancer-radiation~     relationship. Because large numbers of women are exposed to ubiquitous low-dose radiation~     from occupational, medical, and environmental sources, the presence of radiation-sensitive~     genetic variants that influence the risk of breast and other cancers would have important~     public health implications.~   "
240233|NCT00410462|"~     RATIONALE: Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing.~      PURPOSE: This randomized phase II trial is studying the side effects and how well~     brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed,~     refractory, or metastatic soft tissue sarcoma.~   "
240234|NCT00410449|"~     Complications of hemodialysis access are the most frequent single reason for hospitalization~     among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in~     patients with diabetes, is a state of increased oxidative stress. The central hypothesis to~     be tested by this project is that oxidative stress is a major (and modifiable) trigger for~     vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and~     access complications by giving Vitamin E supplementation to patients being treated by~     hemodialysis.~   "
240235|NCT00410436|"~     The purpose of the READI tiral is to examine the effects of resistance training (weight~     training) on the blood sugar control of aerobically active individuals with Type 1 Diabetes.~   "
240236|NCT00410423|"~     Based on what is known about it's mechanism of action, bortezomib is presumed to make other~     chemotherapy drugs work better. This study examines the use of bortezomib in combination with~     an already effective chemotherapy regimen that is used to treat leukemias that have relapsed~     or been refractory to treatment.~   "
240237|NCT00410410|"~     The purpose of this clinical research study is to learn if abatacept can improve signs and~     symptoms of active ulcerative colitis in patients who have not had an adequate response to~     other therapies. The safety of this treatment will also be studied~   "
240238|NCT00410397|"~     Low back pain (LBP) is a common problem in the adult population with many approaches to~     treatment, but no clear answer. One of the causes of LBP, musculoskeletal pain, can be~     triggered by spasm of the deep muscles of the back and pelvis. This study, therefore, focuses~     on treating pelvic muscle pain as a way of lessening LBP.~   "
240239|NCT00410384|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on~     quality of life of two different doses of belimumab administered in addition to standard~     therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE)~     disease.~   "
240240|NCT00410371|"~     This study intends to compare the pharmacokinetic characteristics, safety and tolerability of~     two formulations of lamotrigine in healthy male and female volunteers~   "
240241|NCT00410358|"~     This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in~     Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days,~     to adult patients with advanced solid tumors who have progressed despite standard therapy or~     for whom standard systemic therapy does not exist.~   "
240242|NCT00410345|"~     Induction of midtrimester abortion includes cervical ripening and then contraction to induce~     uterine evacuation. There are several protocols, but most of them include using~     prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and~     limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug~     and been used for induction of abortion in first and second trimesters abortions. The aim of~     this study is to explore the effectiveness of Mifepristone for cervical ripening before high~     dose Oxytocin drip.~   "
240268|NCT00410007|"~     The aim of the study is to test the following hypotheses:~        1. that the function and/or regulation of AQP2 and /or ENaC in the principal cells is~          abnormal in autosomal dominant polycystic kidney disease.~        2. if an abnormal function of the principal cells is present in autosomal dominant~          polycystic kidney disease, this will become more pronounced at high and low sodium~          intake.~   "
240269|NCT00409994|"~     Investigating the safety and the activity of Rapamycin, administered before and during~     preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose~     escalation study will be performed in three steps (2, 4 and 6 mg). Patients entered in phase~     II will follow the same tolerable treatment regimen as patients in phase I study.~   "
240270|NCT00409981|"~     The PACCOCATH ISR II study is a randomized, double-blinded German multicenter trial on the~     efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent~     restenosis.~   "
240243|NCT00410332|"~     Tonsillectomy is one the most common procedures in ear, nose and throat (ENT) medicine.~     Following surgery patients suffer from severe pain and difficulty on swallowing, while~     analgesic treatment has limited efficacy and potential adverse effects such as increased~     bleeding with NSAIDs. Traumeel S is a homeopathic complex remedy used primarily in Europe for~     the treatment of pain and inflammation. It contains a number of plants and minerals at high~     dilutions (between 1x10-2 to 1x10-8), and has been shown to exhibit anti-inflammatory~     properties such as cytokine inhibition in human T cells, monocytes and gut epithelial cells.~     Clinical studies have found Traumeel S reduces post-chemotherapy stomatitis, as well as~     post-surgical inflammation and pain following orthopedic procedures.~      The purpose of this study is to examine the effect of Traumeel S on post-tonsillectomy pain~     in adult patients. The study group will consist of 20 patients age 18 years of age and older~     following elective tonsillectomy. These patients will be randomly assigned to receive~     treatment with either true Traumeel S remedies or placebo. One ampule of Traumeel S (or~     placebo) will be sprayed over the resected area immediately following surgery. Two Traumeel S~     (or placebo) tablets will be taken subsequently 4 times daily (Total: 8 tablets per day)until~     no analgesics are required for 2 consecutive days, or until Day 14 (whichever comes first).~     Patients will be allowed to take dipyrone (Optalgin) 500mg tablets on an as-needed basis, for~     up to 14 days postoperatively. At the end of this period, a thorough ENT examination will be~     done.~      The primary parameter to be evaluated in the study will be postoperative pain, as registered~     on a numerical pain rating scale (NRS), to be filled prior to surgery. In the post-anesthesia~     care unit (PACA) the NRS will be filled out again, this time for pain at rest and then again~     for pain upon swallowing - at 1, 2, 3,4 and 24 hours postoperatively. Secondary parameters to~     be evaluated are: analgesic use (dipyrone); post-operative bleeding (quantified on a scale of~     1-4); nocturnal awakenings; time to resumption of eating and return to normal activity;~     cytokine levels (CRP, IL-6) at 36 hours postoperative; and side effects of the treatment.~   "
240244|NCT00410319|"~     The purpose of this study is to compare a specific fear-reducing information with~     symptom-based exercise~   "
240245|NCT00410306|"~     This is an observational study with a drug called Nebido, a new testosterone replacement~     therapy, which is available for the treatment of male hypogonadism. The benefit and safety of~     Nebido have already been thoroughly evaluated through well controlled clinical trials. The~     main purpose of this observational study is to confirm the established safety profile of~     Nebido in daily clinical practice.~   "
240246|NCT00410293|"~     Diagnostic uncertainty in patients with complaints of shortness of breath presenting to the~     Emergency Department of a hospital may delay treatment and proper care. In patients with~     shortness of breath due to heart failure increased plasma levels of NT-pro-B-type natriuretic~     peptide (NT-proBNP) can be demonstrated. The use of NT-proBNP as a biomarker for heart~     failure in patients presenting to the emergency department with dyspnea might improve care~     and reduce length of hospital stay.~      To investigate the effect of NT-proBNP testing on patient care and time to discharge the~     NT-proBNP test will be randomized. In patients in the study group, the NT-proBNP plasma level~     is determined at admission and the physician in charge will immediately receive the result of~     the test. In patients in the control group blood will be sampled but the physician will~     recieve no information on the NT-proBNP plasma level.~      In our study we will investigate the effect of introduction of NT-proBNP as biomarker for~     heart failure on treatment, time to discharge and costs.~   "
240247|NCT00410280|"~     Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a~     subject with mild asthma inhaling an allergen.~   "
240248|NCT00410267|"~     Selective laser trabeculoplasty (SLT) is a new alternative to anti-glaucoma medications for~     the treatment of primary open angle glaucoma. After SLT, many patients experience mild to~     moderate inflammation inside the eye - specifically in the front chamber of the eye (the part~     in front of the colored part of the eye). This mild front chamber reaction is typically~     treated with anti-inflammatory agents such as corticosteroids and nonsteroidal~     anti-inflammatory agents (NSAIDs). Some physicians do not use these agents as they feel they~     may interfere with the way the laser works to treat glaucoma. Topical (applied to the~     surface) corticosteroids can cause an increase in the pressure of the eye (intraocular~     pressure or IOP), cataract formation, or a possible increase in infection with long-term use.~     These side effects have not been reported to occur with NSAIDs, which are effective in~     controlling pain after SLT and reducing signs of inflammation such as irritation, swelling,~     tenderness, and soreness.~      This research study will compare an NSAID, ketorolac tromethamine 0.4% (Acular LS), with a~     corticosteroid, prednisolone acetate 1% (Pred Forte), and with a placebo, which contains no~     active medicine (Refresh Tears). Ketorolac tromethamine 0.4%, prednisolone acetate 1%, and~     Refresh Tears are all FDA (Food and Drug Administration) approved for use in inflammation~     after surgery.~   "
240249|NCT00410254|"~     To evaluate the potential PK interaction of multiple oral doses of HCV-796 and a single oral~     dose of midazolam when coadministered to healthy subjects.~   "
240250|NCT00410241|"~     This study will examine genome sequencing in clinical research. Genome sequencing is a~     process in which researchers analyze (or sequence) part or all of the genome from a single~     person. The human genome is the material in cells that includes thousands of genes. Gene~     changes that cause or contribute to disease can be passed on from one generation to the next.~     This study first focuses on heart disease. Later, researchers hope to study other conditions~     and genes, with the eventual goal of sequencing most or all of participants genes.~      Participants ages 45 to 65 years of age and who do not smoke, may be eligible for this study.~     Patients will come to the NIH Clinical Research Center for an initial study to last about~     half a day. They will donate a blood sample and complete a short survey. Then they will meet~     the genetic counselor to learn more about genome sequencing. Those who join the study will~     undergo the following procedures and evaluations:~        -  Family history and medical history.~        -  Measurement of height and blood pressure.~        -  Noninvasive heart tests, including electrocardiogram and echocardiogram.~        -  Drawing of about 3 ounces of blood (5 to 6 tablespoons); part of the blood sample will~          be used for research and another part for clinical testing.~        -  Multidetector computed tomography (CT), a test to measure coronary artery calcification,~          that is, condition of inflexibility.~      Each patient will receive a letter with results of the clinical laboratory values and~     evaluations. There will be recommendations for follow-up with the patient s doctors. Risks in~     this study include exposure to radiation from the CT test. The radiation amount used is about~     the same that a person normally receives from natural sources, such as from the sun, outer~     space, and radioactive materials found naturally in the earth s air and soil. Another slight~     risk involves reactions to a contrast agent that may be used in the echocardiogram. Side~     effects can be headache, nausea or vomiting, a warm sensation, and dizziness.~      With the samples that patients provide, researchers will start by sequencing about 400 genes~     related to heart disease. Analysis will take months to complete. Genome sequencing is~     difficult to do, and researchers have much to learn about the genes they sequence and the~     gene changes they find. If the researchers find gene changes that are important to the health~     of a participant, they will contact that participant and give him/her the choice of learning~     such results.~      This study may or may not have a direct benefit for participants. Patients would get free~     clinical testing for cholesterol, diabetes, and other conditions, as well as information~     about gene changes. Knowledge gained will benefit people in the future as researchers learn~     about the relationship between gene changes and health.~   "
240251|NCT00410228|"~     This study will evaluate the safety and tolerability of ascending single oral doses of AHT956~     in healthy subjects~   "
240271|NCT00409968|"~     This trial is referred to as the umbrella trial. The BATTLE program consists of this~     umbrella trial plus four phase II protocols into which the umbrella patients are enrolled.~     Patients will first enroll in the BATTLE umbrella trial and undergo a tumor biomarker~     analysis that will be used to assign them to one of the four phase II studies. All patients~     enrolled in one of the phase II BATTLE protocols must be enrolled in this protocol.~   "
240252|NCT00410215|"~     Colon cleansing prior to colonoscopy is critically important to ensure effective colonoscopy~     for colon cancer screening, which is now widespread in North America. Currently available~     colon cleansing agents are limited either by potential safety concerns or significant~     limitations in the ability of patients to tolerate the preparation. Pico-salax has recently~     been introduced in Canada as an alternative agent and is being used more and more widely~     despite an almost complete lack of clinical data supporting efficacy and safety. This study~     will establish the relative efficacy and patient tolerability of this agent and its safety~     profile. This is a very important, practical issue which continues to challenge~     gastroenterologists, surgeons, internists, family doctors and thousands of their patients in~     Canada on a daily basis.~      Anecdotal evidence suggests that the efficacy of pico-salax when used as a sole agent may not~     be as efficacious as oral sodium phosphate. Hence, our hypothesis is that the combination of~     pico-salax and bisacodyl will provide the most efficacious bowel preparation in comparison~     with oral sodium phosphate and pico-salax alone, while being equally if not better tolerated.~   "
240253|NCT00410202|"~     The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir~     combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine~   "
240254|NCT00410189|"~     Primary Objective:~        -  To determine the 8 week progression-free survival rate (i.e. disease control rate) in~          patients with advanced NSCLC who have failed at least one prior chemotherapy regimen.~      Secondary Objectives:~        -  Determine the overall response rate~        -  Determine the overall survival~        -  Determine the time to disease progression~        -  Assess the safety/toxicity of the study treatment~        -  Assess biomarker modulation in the tumor tissue and serum samples from the treatment~        -  Assess plasma and intra-tumor concentrations of study treatment~   "
240255|NCT00410176|"~     The proposed study will evaluate whether the use of non-pharmaceutical methods, such as~     surgical masks, isolation of patients and personal hygiene, are acceptable and effective in~     preventing the spread of influenza within the family.This will be achieved by conducting a~     randomized, controlled, unblinded, clinical trial. Family members of an index case with~     influenza like illness, will be randomly allocated to two groups. In the intervention group,~     family members will receive comprehensive guidance about sanitation and hygiene, as well as~     surgical masks to wear whenever in close contact (3 feet / 1 meter) with the index case. In~     addition, they will be asked to isolate the index case as much as possible. In the control~     group, family members will receive only standard guidance about sanitation and hygiene~     relevant for reducing the transmission of influenza. The primary end-point of the study will~     be secondary infection of influenza of at least one of the family members in order to asses~     the efficacy of the interventions. In addition, the compliance to those interventions will be~     evaluated.~      The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will~     reduce the secondary infection rate among them by 50%.~   "
240256|NCT00410163|"~     To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with~     chemotherapy in previously untreated patients with B-CLL~   "
240257|NCT00410150|"~     The purpose of this study is to investigate whether heliox-powered albuterol nebulizer~     therapy will result in reduced inpatient length of stay in children hospitalized with acute~     asthma exacerbations.~   "
240258|NCT00410137|"~     prospective longitudinal measurements of nutritional status parameters (body composition by~     BIA, anthropometry and biochemical indexes), inflammatory response (CRP, inflammatory~     cytokines (IL-1, IL-6, IL-10),IGF-1, leptin and NOx blood levels) and morbidity and mortality~     data collection over 2 year period in patients receiving chronic hemodialysis.~   "
240259|NCT00410124|"~     To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic~     carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.~   "
240260|NCT00410111|"~     Septic encephalopathy is an important complication of sepsis. Why some patients with sepsis~     develop septic encephalopathy is unknown. We will investigate whether patients who develop~     this condition have different patterns of cerebrovascular reactivity and whether it is~     possible to predict the development of septic encephalopathy from early measurements of~     cerebral perfusion or from the EEG. We will specifically test the hypotheses that septic~     encephalopathy may not be predicted by changes in the EEG, and that cerebrovascular~     autoregulation is not dysfunctional in septic encephalopathy.~   "
240261|NCT00410098|"~     Cold and dry air induce exercise induced asthma. Yoga training may improve lung function~     tests. Bikram Yoga (heat 39 degree Celsius and humidity 60%)training may improve both lung~     function tests and bronchial hyperreactivity (to exercise and adenosine 5'monophosphate).~   "
240262|NCT00410085|"~     Nitrogen-oxide (NO) plays an important role for blood pressure regulation, renal~     hemodynamics, and the renal excretion of sodium. NO is synthesized from L-arginine in the~     vascular endothelium and have a very short half-life in plasma and is therefore very~     difficult to measure directly.~      L-mono-methyl-L-arginine (L-NMMA) is an analogue to L-arginine and a competitive inhibitor of~     NO, and therefore can be used to study the effect of NO on the circulation. In normal~     subjects, infusion of L-NMMA will cause an increase in blood pressure, decreased renal~     plasma-flow, decreased glomerular filtration rate, and a decreased excretion of sodium.~      Hypothesis: Patients with obstructive sleep apnea has a decreased activity in the NO-system.~     This is contributing to the hypertension often seen in these patients. Decreased activity in~     the NO-system can be revealed by diminished fall in renal hemodynamic and sodium excretion~     after infusion of L-NMMA.~   "
240263|NCT00410072|"~     The purpose of this study is to compare the effectiveness of entecavir plus tenofovir~     combination therapy with that of entecavir monotherapy. Safety will also be studied.~   "
240264|NCT00410059|"~     The goal of this clinical research study is to learn if erlotinib hydrochloride (OSI-774,~     Tarceva®) can help to control NSCLC. The safety of this drug will also be studied, as well as~     the drug's effect on different cells in the body and the participants' overall response.~   "
240265|NCT00410046|"~     The primary purpose of this study is to evaluate the health care resource utilization and~     work status of patients with ankylosing spondylitis undergoing treatment with etanercept by~     comparing study evaluations with the baseline evaluations in the ASCEND~     (0881A3-402)(NCT00247962) study.~   "
240266|NCT00410033|"~     This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at~     comparing the antibody levels in children and adolescents.~   "
240278|NCT00409864|"~     Cancer of the gallbladder (CaGB) is one of the most common causes of malignant obstructive~     jaundice. Jaundice is the second most common presentation and occurs in 30-60% of patients~     with CaGB. It is obstructive in nature and frequently associated with pruritus, which is very~     disturbing for the patients. The usual mechanism of obstruction is direct infiltration of the~     bile duct by the tumour. Most patients with CaGB with obstructive jaundice are not amenable~     to a curative surgical resection and hence effective palliation is the goal of treatment.~     Although surgical bypass has been the traditional palliative approach, it is associated with~     substantial morbidity and mortality. Non-operative alternatives in the form of percutaneous~     and endoscopic drainage are available. A few trials have shown that endoscopic drainage is~     better than percutaneous drainage in patients with lower end bile duct obstruction due to~     pancreatic and peri-ampullary cancer. However, the scenario is quite different in patients~     with upper end of bile duct obstruction as occurs due to CaGB. Endoscopic drainage is~     associated with a higher incidence of cholangitis in patients with a block at the upper end~     of the bile duct and the success rate varies from 40% to 80%, while percutaneous drainage may~     be associated with complications such as biliary leak and bleeding. There has been no~     randomized trial comparing endoscopic and percutaneous drainage in patients with malignant~     obstruction due to CaGB. The objective of the present study is to carry out a randomized~     prospective trial comparing percutaneous and endoscopic biliary drainage in patients with~     CaGB with obstructive jaundice and to assess their quality of life.~   "
240279|NCT00409851|"~     A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.~   "
240280|NCT00409838|"~     The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight~     tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate~     after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and~     an inadequate clinical response to methotrexate~   "
240281|NCT00409825|"~     We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second~     and third trimesters.~   "
240282|NCT00409812|"~     The study will be undertaken at the ENT department of the Leicester Royal Infirmary and in a~     research laboratory at the University of Leicester and also in the ENT department at the West~     Suffolk Hospital. One hundred subjects will be recruited. Subjects will be invited to undergo~     a series of smell tests using graded concentrations of 4 odours in 120ml bottles (1). This~     test has been described and validated by our previous work (2). The test will be fully~     explained to the subject beforehand by the researcher who will test the patient. The subject~     will be started with the smallest concentration of each odour and will ascend through the~     bottles until they detect 2 in a row, at which point the weaker concentration of the odour~     will be taken as their threshold. They will have a threshold levels determined for the odours~     phenethyl alcohol (roses), mercaptan (gas), acetic acid (vinegar) and eucalyptol (menthol).~      Then, the subject will undergo a sodium citrate nasal douche at a specific concentration or~     will douche with sterile water. There will be three concentrations used (3%, 6% and 9%) and a~     control solution (sterile water). Patients will be randomly allocated to one of the four~     groups using a coded bottle system. Both patient and tester will be blinded to the solution~     used as these will be made in the pharmacy and coded for anonymity – the code will be broken~     at the end of the trial. Subjects will then be retested with the bottles and threshold levels~     will be observed for the four odours at 15 minute intervals over 2 hours. The purpose of the~     repeated tests is to determine the length of the effect (if present) of the citrate on the~     olfactory ability of the patients.~      (N.B. Sodium citrate is a licensed product for use in body cavities (e.g. stomach, bladder)~     and can be found in the British National Formulary – the concentrations proposed do not~     exceed those used elsewhere.)~        1. Wudarski TJ, Doty RL. Comparison of detection threshold values determined using glass~          sniff bottles and plastic squeeze bottles.Percept Mot Skills. 2004 Feb;98(1):192-6~        2. Gaskin J, Robinson A, Philpott CM, Goodenough P, Murty G. Are patients cross-sensitive~          to odours in parallel threshold tests? Chemical Senses 2006; in progress~   "
240283|NCT00409799|"~     For certain tibial plateau fractures the bone is compressed due to the force acting on the~     tibia during the accident. The void provoked by the compression of the bone is filled with an~     appropriate filling material and the fracture is fixated. I 0401 is a new bone graft~     substitute that has shown capacities to promote bone-healing. This study will test the safety~     and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring~     grafting.~   "
240284|NCT00409786|"~     Diabetes affects 18 million Americans and costs over $132 billion in both direct treatment~     and lost productivity per year. It is known that weight loss, improved diet and increased~     exercise can result in improvement in glucose, lipid, and blood pressure control in patients~     with diabetes and reduce the incidence of diabetes in individuals at high risk. Effective~     delivery of proven, comprehensive lifestyle programs is difficult because of associated high~     costs.~      The internet provides a venue to deliver these lifestyle programs to large numbers of~     individuals while decreasing the cost per person. HealthTrak, the University of Pittsburgh~     Medical Center (UPMC) patient portal, provides an ideal setting to test such a program.~     HealthTrak provides participants with access to individual medical information while~     facilitating electronic communication with their physicians. Portal enhancements will allow~     the delivery of a comprehensive lifestyle intervention aimed at weight loss, improved diet,~     and increased exercise, and provide the opportunity to communicate with experts regarding~     concerns.~      Through this project, we will evaluate the modification of a successful comprehensive~     lifestyle intervention for delivery through HealthTrak. We will enroll and follow 50~     individuals with diabetes or at high risk for diabetes for 12 months and examine change in~     parameters including diet, weight, physical activity, hemoglobin A1C, glucose, blood~     pressure, and lipid profile.~   "
240285|NCT00409773|"~     A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high~     risk for coronary heart disease to study the effects of ezetimibe/simvastatin and~     atorvastatin on lipids.~   "
240286|NCT00409760|"~     This trial will compare valsartan and amlodipine combination therapies to both valsartan and~     amlodipine, and placebo for the treatment of hypertension.~   "
240301|NCT00409565|"~     The purpose of this study is to determine if the combination of two new drugs, cetuximab~     (Erbitux) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and~     neck cancer. Cetuximab has recently been approved by the FDA for head and neck cancer (that~     is locally or regionally advanced) when used in combination with radiation therapy. Cetuximab~     is also approved by the FDA for the treatment of colorectal cancer~   "
240321|NCT00409279|"~     The goal of this project is to test an intervention designed to reduce the incidence and~     magnitude of the negative effects, specifically stress, anxiety, and depression, frequently~     experienced by adult children who are caregivers of a parent with Alzheimer's disease (AD).~   "
240322|NCT00409266|"~     The functional flexion axis of the knee can be established by computer-assisted~     intra-operative data, through range of motion techniques, not specific landmarks such as~     epicondyles.~   "
240287|NCT00409747|"~     There is a subgroup of children with autism that appears to develop typically for a period of~     time, and then loses social or language skills, or regresses. A recent study by Vargas and~     co-workers at Johns Hopkins has demonstrated that this regressive type of autism is~     associated with chronic brain inflammation as shown by an abnormal production of inflammatory~     cytokines among other abnormalities.~      This present study will test the effectiveness of minocycline, an antibiotic with~     anti-inflammatory properties, in treating regressive autism. Although behavioral therapies~     have improved some symptoms of autism, there are no medical treatments for the disorder, and~     many children have ongoing behavioral difficulties. A medicine with anti-inflammatory~     properties may be beneficial for children with regressive autism.~      This will be an open-label trial, meaning all children in this study will receive~     minocycline. They will also receive vitamin B6 to reduce the possible chance of side effects~     of the minocycline.~      Children ages 3 to 12 with regressive autism may be eligible for this study. The children~     will take minocycline and vitamin B6 daily for 6 months. Prior to starting the medication and~     vitamin B6, children will receive a comprehensive diagnostic assessment for autism as well as~     a physical examination, medical history, and laboratory tests. Children will then receive~     ongoing assessments to monitor their behavior, communication, language skills, and medical~     issues at 2 weeks, and at 1, 2, 4, 6, and 12 months. Children who respond to the treatment~     will receive an additional 3 months of minocycline and vitamin B6.~   "
240288|NCT00409734|"~     The purpose of this study is to determine if there is an increase in the frequency of formula~     change in patients with pyloric sctenosis prior to being correctly diagnosed.~   "
240289|NCT00409721|"~     The purpose of the study is to investigate the effects of memantine in ALS patients using~     functional outcome measures.~   "
240290|NCT00409708|"~     This study will assess the frequency of chromosomal abnormalities measured in circulating~     lymphocytes in treatment-naive children with Attention Deficit Hyperactivity Disorder (ADHD)~     treated for 3 months with either extended release methylphenidate or behavioral therapy.~   "
240291|NCT00409695|"~     Primary Objective:~        -  To determine the response and toxicity rate at day 56 of two different dose levels of~          thymoglobulin (ATG) [anti-thymocyte globulin (rabbit)] as a treatment of~          steroid-refractory acute graft versus host disease (aGVHD).~      Secondary Objectives:~        -  To evaluate the response rate at day 28.~        -  To evaluate the overall survival and non-relapse mortality at 6 months.~        -  To determine the toxicity profile of thymoglobulin when used for the treatment of~          steroid-refractory aGVHD in each of two dose schedules.~        -  To characterize the pharmacokinetic profile of thymoglobulin in each of two dose~          schedules.~        -  To analyze biomarkers of cellular drug effect by quantifying T-cell apoptosis in aims of~          finding the minimal effective dose.~        -  To determine immune-reconstitution after administration of thymoglobulin to patients~          with steroid-refractory aGVHD for each dose schedule.~   "
240292|NCT00409682|"~     The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of~     Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease~   "
240293|NCT00409669|"~     To determine if the Barraquer tonometer provides an accurate and reliable measurement of~     intraocular pressure. The Barraquer tonometer is a device used to safely and painlessly~     measure intraocular pressure.~   "
240294|NCT00409656|"~     Most high risk keratoplasties are currently performed under systemic immunosuppression.~     Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile,~     administered for around 6 months. Due to potentially severe adverse effects, new~     immunosuppressive exerting less side effects would be desirable. Basiliximab is a monoclonal,~     chimeric antibody, targeted specifically against the Interleukin-2-Rezeptor from activated~     T-cells. This agent is known to specifically inhibit T-cell proliferation upon intravenous~     application only twice following transplantation. Basiliximab has already been demonstrated~     effective in kidney transplantation.~      This investigation is a prospective, randomized clinical trial on orthotopic, high-risk~     penetrating keratoplasty. Basiliximab is evaluated against systemic Cyclosporine A. Primary~     endpoint is graft rejection. Secondary endpoint is clear graft survival.~   "
240295|NCT00409643|"~     This trial will compare valsartan and amlodipine combination therapies to valsartan and~     amlodipine monotherapy,and placebo for treating patients with hypertension~   "
240296|NCT00409630|"~     Subjects between the ages of 20-45 with mild to moderate asthma will be recruited. Following~     consent, subjects will undergo an evaluation to assure no underlying metabolic bone disease.~     Individuals will be treated with inhaled fluticasone low or high dose, daily for 3 months.~     Serum and urine biochemical markers of bone metabolism will be collected at baseline and~     monthly for three months. Adherence to study medication and adverse events will be collected~     at monthly intervals. Differences between fluticasone low and high dose treated individuals~     will be analyzed between groups and compared with baseline values.~   "
240297|NCT00409617|"~     The purpose of this study is to evaluate the safety of adalimumab for treatment of patients~     with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on~     patient general well-being, health-related quality of life (QoL), fistula healing, CD-related~     extra-intestinal manifestations, work performance, and overall activity.~   "
240298|NCT00409604|"~     To determine whether the application of ventricular pacing can protect the human heart from~     damage resulting from a myocardial infarction~   "
240299|NCT00409591|"~     The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given~     only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose~     (SD) NVP given to the mothers plus two doses to the infants, in addition to zidovudine (ZDV)~     prophylaxis (from 28 weeks' gestation and for one week of ZDV in neonates) for the prevention~     of mother-to-child transmission of HIV-1.~   "
240300|NCT00409578|"~     The purpose of this study is to test the hypothesis that the inhibition of the~     renin-angiotensin-aldosterone system (RAAS) with the angiotensin receptor blocker valsartan~     or the renin antagonist aliskiren will improve ventricular hemodynamics, as reflected by a~     greater reduction in levels of N-terminal proB-type natriuretic peptide (NT-proBNP) compared~     to placebo in subjects stabilized following acute coronary syndrome (ACS) who are determined~     to be at high risk due to an elevated concentration of natriuretic peptides.~   "
240302|NCT00409552|"~     A number of studies have shown that virtual reality (VR) can be used to distract patients~     from pain and anxiety during painful medical procedures for which medication provides~     inadequate relief. An inexpensive, commercially available VE could have significant impact in~     reducing perceived pain involved in a variety of medical procedures. The Virtual Reality~     Medical Center (VRMC) developed an engaging virtual world that proved to be effective in~     reducing reported pain ratings of participants experiencing several different forms of~     painful stimuli. The virtual world called Icy Cool World was found to successfully distract~     patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks~     to expand on these findings and examine the effectiveness as a pain distraction technique for~     a variety of acute and chronic pain etiologies. The main objective of the clinical~     investigation will be to expand on the findings from earlier studies and obtain a more~     comprehensive analysis regarding the clinical versatility of VR pain distraction.~   "
240303|NCT00409539|"~     SMP-986 is a compound being developed for the treatment of overactive bladder syndrome~     (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg,~     40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The~     hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with~     SMP-986 compared to placebo, as well comparing the change in: the severity of urgency~     episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr~     and the mean void volume/void between SMP-986 and placebo.~   "
240304|NCT00409526|"~     Inhaled Iloprost will be administered to near term infants with Persistent Pulmonary~     Hypertension of the Newborn in two different doses in order to test safety and efficacy in~     reducing pulmonary artery pressure.~   "
240305|NCT00409500|"~     This study will evaluate safety, tolerability and pharmacokinetics of individual oral doses~     of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the~     pharmacokinetics of AQW051.~   "
240306|NCT00409487|"~     The main objective of the study is to compare the decrease of mean arterial blood pressure~     over 24 hours in patients having obstructive sleep apnea syndrome and weak or moderate~     hypertension, treated by Valsartan 160mg per day versus continuous Positive Airway Pressure.~   "
240307|NCT00409461|"~     Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG~     SIR) each consisting of ten type 1 diabetic patients~   "
240308|NCT00409448|"~     This study will evaluate the effectiveness of an Internet-based psychosocial treatment in~     improving problem-solving, communication skills, stress management strategies, and coping~     among children who have had a traumatic brain injury and their families.~   "
240309|NCT00409435|"~     This is a 3-day study comparing pyridostigmine versus placebo in the treatment of postural~     tachycardia syndrome (POTS). The researchers expect pyridostigmine to improve tachycardia and~     stabilize blood pressure.~   "
240310|NCT00409422|"~     To compare anthropometric and metabolic effects of a comprehensive weight management program~     on obese adolescents and children in comparison to regular clinical weight management visits.~   "
240311|NCT00409409|"~     A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens~     compared with placebo for reduction of symptoms and rescue medication usage in children.~   "
240312|NCT00409396|"~     The purpose of this study is to determine whether urinary PGE-M levels correlate with~     Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with~     other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.~   "
240313|NCT00409383|"~     This study is designed to evaluate the safety, efficacy, pharmacokinetics, and~     pharmacodynamics of combination treatment with Temodar®, Genasense®, and Abraxane® in~     chemotherapy-naïve subjects with advanced melanoma and normal lactate dehydrogenase (LDH).~   "
240314|NCT00409370|"~     This study compared standard hospital restraints to a newer safety net restraint system to~     compare them for acceptability, tolerance, duration of restrain, length of stay in the~     hospital, and satisfaction of MD, nurse, and relatives of patients.~   "
240315|NCT00409357|"~     The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin~     hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral~     administration period for the efficacy in patients with lower urinary tract symptoms (LUTS)~     related to BPH.~      Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with~     placebo and to assess the safety of each dose of alfuzosin.~   "
240316|NCT00409344|"~     The primary objective of this study is to test the hypothesis that time on the ventilator and~     ICU length of stay will be shorter in TAA patients given postoperative sedation with~     dexmedetomidine compared to those given standard sedation. Secondary endpoints are:~     requirement for sedatives vasoactive drugs incidence of postoperative delirium and cost~     analysis.~   "
240317|NCT00409331|"~     Primary Objective:~      To determine if amifostine in combination with IMRT can mitigate the decrease in production~     of saliva by the submandibular and sublingual salivary glands in patients with HNSCC.~      Secondary Objectives:~        1. To establish a parotid gland dose volume histogram (DVH) versus measured flow~          relationship in this patient population:~             -  When the mean dose is < 24-26 Gy (shift recovery time to left)~             -  When the mean dose is > 24-26 Gy (DVH shift)~        2. To observe mucositis in the following lower dose RT areas:~             -  Upper lip~             -  Lower lip~             -  Right cheek~             -  Left cheek~             -  Right ventral and lateral tongue~             -  Left ventral and lateral tongue~             -  Floor of the mouth~             -  Soft palate~             -  Hard palate.~        3. To observe the incidence and patterns of occipital scalp epilation;~        4. To observe the incidence of dysphagia using the List Performance Status Scale (LPSS);~          and~        5. To further evaluate the safety profile of amifostine in this patient population.~   "
240318|NCT00409318|"~     This study investigates whether blockade of TNF will result in reduced inflammatory indices~     in patients with the metabolic syndrome~   "
240319|NCT00409305|"~     The purpose of this study is to examine the effect that betahistine has on body weight in~     obese subjects.~   "
240320|NCT00409292|"~     The purpose of this research study is to investigate if RAD001 is an effective treatment for~     pancreatic cancer that has spread and not responded to treatment. Experiments have shown that~     RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory~     experiments imitating cancer conditions and the results have been promising.~   "
240323|NCT00409253|"~     The aim of this study is to confirm that URAPIDIL is as efficient and as safe as NICARDIPINE~     to correct severe hypertension in pre-eclamptic patients.~        -  efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min~          of study drug administration.~        -  safety endpoints : clinical, biological and ultrasound observation for any side~          effect.All infants will be observed in the neonatology unit (during 48h).~   "
240324|NCT00409240|"~     Our study intends to test the efficacy of pharmacist-led group interventions on a weekly~     basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant~     reductions in hemoglobin A1c, lipids and blood pressure.~   "
240325|NCT00409227|"~     In latest literature more evidence is available about the positive effect of alpha blocker on~     stone expulsion from the ureter. Patients benefit from less pain and shortening time to stone~     expulsion. Our study is design to evaluate whether alfuzosin improves the stone free out come~     following SWL.~   "
240326|NCT00409214|"~     The pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the~     zone of tumor destruction with escalated light doses following intraoperative treatment of~     primary or recurrent glioma.~   "
240327|NCT00409201|"~     30 patients will randomly be selected and will be administered either reboxetine or a~     placebo. changes in cognition and behavior will be assessed by computer tests and scales~     during a six week study period.~   "
240328|NCT00409188|"~     The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in~     addition to best supportive care is effective in prolonging the lives of subjects with~     unresectable stage III non-small cell lung cancer, compared to best supportive care alone.~      A local ancillary (sub) study in European centers will evaluate the immune response in~     peripheral blood after tecemotide (L-BLP25) or placebo vaccination.~   "
240329|NCT00409175|"~     This study will examine whether Fx-1006A is effective in halting the progression of Familial~     Amyloid Polyneuropathy (FAP).~      Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of~     amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the~     condition called FAP.~      The prevention of the formation of amyloid by stabilization of the TTR native state should~     constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR~     stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP~     patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless~     neurological deterioration FAP patients experience.~      This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and~     stabilize the disease at a point in time where progression of motor and autonomic dysfunction~     can be maximally effected. Male and female patients with FAP with documented V30M TTR~     mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.~   "
240330|NCT00409162|"~     A new mechanical device is evaluated for tattoo removal, comparing two types of needle~     washing fluids. 30 healthy subjects with tattoos will be treated. The study hypothesis is~     that the device can be used to achieve satisfactory tattoo removal.~   "
240331|NCT00409149|"~     Intervention description:~      Complementary Approaches to Lower Mean arterial pressure (CALM) is a multi dispensary program~     aimed to reduce blood pressure in hypertensive patients. The program utilizes a naturopathic~     dietary approach, education on cooking and food consumption choices, walking physical~     exercise, Qi Gong - a form of Chinese slow movement exercise combined with relaxation~     breathing and imagery and group therapy coaching in stress management techniques and~     mind-body balancing techniques.~      Trial Objectives:~      To compare the effect of CALM in reducing blood pressure to the standard dietary DASH~     approach in hypertensive patients.~      Methodology:~      120 Participants will be randomly assigned in to two groups:~        -  CALM program for reducing blood pressure as the treatment group.~        -  Standard DASH diet and lifestyle modification counseling as the control group. Inclusion~          Criteria~        -  Adult men and women over 18 years.~        -  Patients using anti hypertensive medications with mean systolic blood pressure~          measurements of 120-180 mm Hg and/or mean diastolic measurements of 70-100 mm Hg as~          determined by a 24 hour Holter test.~        -  Patients not using anti hypertensive medications with mean systolic blood pressure~          measurements of 130-180 mm Hg and or mean diastolic measurements of 80-100 mmHg.~        -  Signed informed consent (appears in IRB forms)~      Assessment of Efficacy Primary end point efficacy will be assessed by comparing the mean BP~     measurements in the CALM group to the mean BP measurements in the DASH control group. Blood~     pressure measurements will be performed by 24 hours Holter BP monitoring in the beginning and~     at the end of the trial.~      Secondary end points efficacy will be assed by comparing CALM to DASH programs with respect~     to effects use of BP medications and weight loss. Lab test and pulse wave analysis will also~     be assessed at the beginning and at the end of the study.~   "
240332|NCT00409136|"~     To evaluate physician response to human alerts that inform the clinician that his/her patient~     may be eligible for thromboprophylaxis. Medical records are reviewed to evaluate prescribing~     decision and to evaluate rates of venous thromboembolism.~   "
240333|NCT00409123|"~     This study tests whether women with Vasospastic Syndrome (VS) react more intensive than~     controls with distal vasomotions and choroidal blood flow changes to internal cooling/warming~     and external cooling/warming.~   "
240334|NCT00409110|"~     This study intends to investigate the relationship between choroidal blood flow and ocular~     pulse amplitude (OPA).~   "
240335|NCT00409097|"~     The purpose of this study is to determine whether Rosiglitazone,decreases the ADMA~     concentration and thereby increases the arginine/ADMA ratio of critically ill patients.~   "
240336|NCT00409084|"~     Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood~     pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have~     an increased risk of bleeding each year. Current recommendations are to prevent bleeding of~     medium or large varices (when there is no history of bleeding) by starting a blood pressure~     lowering agent known as a non-selective beta-blocker. Alternatively, rubber bands can be~     placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation).~     Using both therapies at the same time has not been studied. In this study, we hope to~     determine if the use of combination therapy with endoscopic variceal band ligation and beta~     blockers is more effective than using beta blockers alone to prevent the first bleeding~     episode from the varices (dilated veins). The efficacy, ability to tolerate, and~     cost-effectiveness of these two treatment strategies will be compared.~   "
240337|NCT00409071|"~     The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is~     effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer.~      Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo.~      The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual~     analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198~     per arm). It has been estimated that the enrollment period should be 18 months.~   "
242196|NCT00384319|"~     The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System~     is able to quickly and conveniently cool patients who are comatose after resuscitation from~     cardiac arrest.~   "
240338|NCT00409058|"~     The purpose of this study is to learn if using the World Wide Web to train teens and their~     families in problem-solving, communication skills, and stress management strategies can help~     them to cope better following traumatic brain injury (TBI). To answer this question, we will~     look at changes from before the intervention to after the intervention on questionnaire~     measures of problem-solving skills, communication, social competence, adjustment, and family~     stress and burden. We hypothesize that families receiving the TOPS intervention will have~     better parent-child communication and problem-solving skills at follow-up than those~     receiving the IRC intervention. Additionally, families receiving the TOPS intervention will~     have lower levels of parental distress, fewer child behavior problems and better child~     functioning than those receiving the IRC intervention. Lastly, treatment effects will be~     moderated by SES and life stresses, such that families with greater social disadvantage will~     benefit more from the TOPS intervention.~   "
240339|NCT00409045|"~     we evaluate the presence of OSA in patients that have a computed tomography (CT) of the chest~     to rule out pulmonary embolism (PE) to determine if OSA constitutes an independent risk~     factor for PE.~   "
240340|NCT00409032|"~     The primary objective of the study is to compare dose-response effect of three dose levels of~     strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of~     treatment.~   "
240341|NCT00409019|"~     The purpose of this study is to find out if taking a combination of telbivudine and adefovir~     or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have~     been taking adefovir alone for at least 5 months and have had less than optimal responses.~     The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together~     will also be studied.~   "
240342|NCT00409006|"~     The purpose of this study is to compare the efficacy and safety of chemotherapy followed~     sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small~     cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified~     as 'never smoker' since it is suggested that these patients are more likely to respond~     favorably to treatment with gefitinib.~   "
240343|NCT00408993|"~     To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic~     Neuropathy.~   "
240344|NCT00408980|"~     The aim of this study is to verify whether dietary manipulations in lactating women allow~     increasing the fat and caloric content of human milk.~   "
240345|NCT00408967|"~     The purpose of this study is to determine if either of two doses of EMD 273066 when given~     with a low dose of cyclophosphamide will result in a second time to progression that is as~     long or longer than the first time to progression~   "
240346|NCT00408954|"~     This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in~     men with lower urinary tract symptoms.~   "
240347|NCT00408941|"~     The aim of the present study was to investigate the sensitivity of AEP (auditory evoked~     potentials) to muscular artefacts using sedation and local anesthesia.~   "
240348|NCT00408928|"~     The purpose of this research study is to test the safety and effectiveness of VELCADE® in the~     treatment of acute graft-versus-host disease (GVHD) that has not responded to steroids or has~     worsened when the steroid dose was decreased. VELCADE® is a drug that inhibits certain immune~     reactions that happen when lymphocytes encounter foreign substances. We are doing this~     research to determine if VELCADE® may be useful in treating GVHD.~   "
240349|NCT00408915|"~     The aim of the study is to evaluate the long-term efficacy, local tolerability and safety of~     Lisuride applied as subcutaneous infusion compared to placebo in patients with advanced~     Parkinson's disease with motor fluctuations and OFF periods refractory to conventional~     treatment.~   "
240350|NCT00408902|"~     This phase II trial is studying how well tandutinib works in treating patients who have~     undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney~     cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to~     the tumor. Giving tandutinib after surgery may kill any tumor cells that remain after~     surgery.~   "
240351|NCT00408889|"~     Early organ failure occurs frequently and is difficult to predict. The study aims to define a~     predictive score for early transplant failure.~   "
240352|NCT00408876|"~     The primary purpose of your participation in this study is to help answer the following~     research question, and not to provide you treatment for your condition--Whether duloxetine~     once daily can help patients with Chronic Low Back Pain.~   "
240353|NCT00408863|"~     Postmenopausal women with a history of breast cancer often suffer from climacteric symptoms~     such as hot flushes and sweating episodes. Conventional hormone therapy is not allowed in~     such patients because there are indications that hormones may cause breast cancer to recur.~      Tibolone is a steroid with estrogenic, progestogenic and androgenic activity and is~     registered for treatment of climacteric complaints. Tibolone has a pharmacologic and clinical~     profile that is different from conventional hormones. In contrast to conventional hormones,~     tibolone does not increase breast density and causes less breast pain.~      The LIBERATE study is a study in which the safety and efficacy of tibolone has been~     investigated in postmenopausal women that have been treated for breast cancer.~   "
240354|NCT00408850|"~     An abdominal distribution of fat is associated with the greatest heart disease risk, because~     commonly, several risk factors of metabolic origin cluster in these individuals. When this~     occurs the condition is called the 'metabolic syndrome'.~      Increased activity of the sympathetic nervous system resulting in enhanced release of the~     stress hormone 'noradrenaline', may be one mechanism by which adverse cardiovascular and~     metabolic sequela of the metabolic syndrome might be mediated. Impaired insulin action may be~     one factor contributing to increased noradrenaline release.~      The aim of this Study is to determine whether treatment with a drug called pioglitazone which~     is known to improve insulin action, results in reduced sympathetic nervous system activity~     and stress hormone release when compared to treatment with a dummy drug (placebo).~   "
240367|NCT00408655|"~     This phase I trial is studying the side effects and best dose of temsirolimus, carboplatin,~     and paclitaxel in treating patients with advanced solid tumors. Temsirolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     temsirolimus together with chemotherapy may kill more tumor cells.~   "
240355|NCT00408824|"~     The metabolic syndrome is a highly prevalent disorder, which causes atherosclerotic~     cardiovascular disease and is closely associated with insulin resistance. The alteration of~     the secretion of adipocytokines from accumulated visceral adipose tissue in the obese induces~     insulin resistance. The purpose of this study is to identify gene polymorphisms that confer~     susceptibility to the metabolic syndrome and to make up a new health guidance program based~     on genetic risk assessment. About 25% of male employees over 45 years old in a certain~     company are diagnosed with the metabolic syndrome in medical examination. We, the researchers~     at Nagoya University, will analyze gene polymorphism and various biomarkers of over 3500~     company employees.~   "
240356|NCT00408798|"~     The purpose of this study is to examine prospectively the safety and efficacy of Botulinum~     Toxin A (Botox) injections in the treatment of patients with alopecia areata of the scalp.~   "
240357|NCT00408785|"~     This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group~     comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for~     the Chinese patients with glabellar lines. The subjects will receive a single intramuscular~     treatment consisting of 5 injections of either BOTOX? 20U or placebo.~   "
240358|NCT00408772|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Radiofrequency ablation uses a~     high-frequency, electric current to kill tumor cells. Giving chemotherapy and bevacizumab~     before surgery or radiofrequency ablation may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine~     together with bevacizumab followed by surgery and/or radiofrequency ablation works in~     treating patients with colorectal cancer that has spread to the liver and cannot be removed~     by surgery.~   "
240359|NCT00408759|"~     xerostomia develops in all patients with head and neck cancer following radiotherapy. it~     consists one of the main side effects which affects quality of life. currently, there is no~     standard of care for treating this condition. parasympathomimetic drugs may help but carry~     significant side effects.~      hypnosis may affect autonomic function such as salivation, in healthy people.in this study we~     will explore the efficacy of hypnosis in improving salivation, in the patient population.~   "
240360|NCT00408746|"~     Preterm infants account for 6 % of all live-births in western societies. Scientific evidence~     can be found for altered palatal morphology in the short term among preterm children. Oral~     intubation and orogastric feeding might be contributing factors to these alterations, but it~     has not been examined whether in the absence of these interventions preterm infants' palates~     are altered a priori as compared to term infants, e.g. due to immaturity of the bones or due~     to immaturity of oral function. Because of contradictory results, lack of longitudinal and~     high quality standard studies, the scientific evidence is also to weak to answer the question~     whether premature birth without or with a history of orotracheal intubation and orogastric~     feeding causes permanent alteration of orofacial development. The aim of the present study,~     therefore is to investigate in consideration of perinatal, biometrical, nutritional,~     functional and parental parameters.~   "
240361|NCT00408733|"~     Recent studies have demonstrated that patients sub-optimally understand hospital discharge~     medication instructions Health literacy has been shown to be an important factor in patient~     understanding of medical information , and following medication instructions.~      The primary aim of this project is to test the efficacy of a low-literacy discharge~     medication education tool on medication adherence, and patient knowledge and understanding of~     inpatient discharge medications, in a low-income population with low health literacy levels.~     This evaluation is a prospective trial with patients randomly assigned to either receiving~     this tool or receiving the current standard of care. Given the complexity of the discharge~     medication regimen for the conditions of congestive heart failure (CHF) and coronary artery~     disease (CAD), and the proven effectiveness of these medications in the post discharge~     period, this trial will focus on the subpopulation of patients hospitalized with these two~     conditions.~   "
240362|NCT00408720|"~     The purpose of this study is to compare the newly released Spectral OCT/SLO (OTI, Toronto,~     Canada) with the Zeiss Stratus OCT (Carl-Zeiss Meditec, Dublin, CA) with regards to the~     quality of the images obtained as well as the ease of use.~   "
240363|NCT00408707|"~     The purpose of this study is to examine whether local infiltration analgesia (LIA) with~     Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total~     knee arthroplasty.~   "
240364|NCT00408694|"~     This phase II trial is studying how well giving bevacizumab together with cisplatin,~     radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III,~     stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab,~     can block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the~     tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab~     together with chemotherapy and radiation therapy may kill more tumor cells.~   "
240365|NCT00408681|"~     RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host~     disease caused by a donor stem cell transplant.~      PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute~     intestinal graft-versus-host-disease after donor stem cell transplant.~   "
240366|NCT00408668|"~     The purpose of this study is to test three candidate malaria vaccines in new combinations to~     assess their efficacy at preventing malaria infection and triggering immune responses against~     malaria.~   "
240417|NCT00407979|"~     Cathelicidins are small proteins in the human body that protect against infection. The~     purpose of this study is to determine if the amount of cathelicidins and other small proteins~     found in saliva can predict the amount of these in the skin of people who have acute atopic~     dermatitis (AD) or psoriasis.~   "
240368|NCT00408642|"~     In southern Africa, TB is the most common first AIDS-defining condition. Initiating~     Antiretroviral therapy (ART) in HIV positive TB patients will lead to the inclusion of the~     majority of HIV/AIDS patients currently fulfilling the criteria for therapy. Establishing an~     effective intervention to increase treatment adherence in this group is essential for the~     successful roll out of ART in the region. This proposed randomized controlled study aims to~     compare the effectiveness of two adherence support programmes (ASP) for use in patients with~     HIV-related TB in the context of CAPRISA AIDS Treatment (CAT)programme in KwaZulu-Natal,~     South Africa; the enhanced adherence support programme (E-ASP) or the standard adherence~     support programme (S-ASP).~      S-ASP consists of three counselor presented, group education sessions. E-ASP is an extension~     of S-ASP and is based on the Information-Motivation-Behavioral Skills (IMB) Model of~     Adherence to Antiretroviral Therapy, a theoretical model initially developed to reduce HIV~     risk behavior. The E-ASP will consist of several interconnected components: 1) development~     and maintenance of an educational and supportive milieu at the CDC Clinic, 2) provision of~     five structured educational, support and behavioral skills building sessions, and (3) three~     weekly ART planning sessions.~   "
240369|NCT00408629|"~     This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed~     to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal~     antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis~     (UC).~   "
240370|NCT00408616|"~     The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces~     the hayfever symptoms and the use of symptom relieving medications in children during the~     grass pollen season~   "
240371|NCT00408603|"~     The purpose of this study is to evaluate the objective response rate, safety and identify~     potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin~     injection given on a 28-day cycle.~   "
240372|NCT00408590|"~     RATIONALE: A gene-modified virus may be able to kill tumor cells without damaging normal~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of an attenuated~     oncolytic measles virus therapy and oncolytic virus therapy in treating patients with~     progressive, recurrent, or refractory ovarian epithelial cancer or primary peritoneal cancer~     (measles virus vaccine therapy study closed as of 06/02/2008).~   "
240373|NCT00408577|"~     Impaired glucose tolerance or mild glucose elevations in the non-diabetic range are~     associated with increased cardiovascular disease and recent studies suggested the need to~     detect these glucose abnormalities early in the post-infarction period. Although in the last~     ten years procedures of coronary revascularisation have dramatically improved the outcome of~     non diabetic patients affected by ischemic heart disease, these procedures are less effective~     in patients with type 2 diabetes mellitus and IGT. Possible causes of worse prognosis in~     these patients could be related to the presence of hyperinsulinemia and insulin resistance~     due to the well known effect of insulin to increase neointimal tissue proliferation and~     in-stent restenosis, by stimulating vascular smooth muscle cell growth factors and migration.~     In addition, it is well known that endothelial dysfunction is an early functional disturbance~     in the development of atherosclerotic lesions. The impairment of eNOS action might change the~     turnover rate of eNOS or nitric oxide production and action influencing nitric oxide~     signalling, apoptosis cascade and angiogenesis. All these factors can contribute to~     endothelial dysfunction to a certain extent, and accelerate atherosclerosis with increased~     risk for cardiovascular disease.~      The constitutively expressed eNOS, is likely to be the major contributors to whole-body~     nitric oxide production. It is interesting to note that a region of chromosome 7q seems to~     influence both insulin resistance and blood pressure, suggesting that this locus may broadly~     influence traits associated with insulin resistance.~      L-arginine is an essential amino acid and its availability is important for the normal~     endothelial cell function and its intracellular reduction may contribute to the dysfunctional~     endothelial state. It is well known that L-arginine is as a precursor for nitric oxide and~     both in vitro and in vivo studies have demonstrated that L-arginine can augment vascular~     dilation under certain conditions.~      Our hypothesis is to evaluate the modulating effect of L-arginine on metabolic, endothelial~     variables and on myocardial function in patients with cardiovascular disease.~   "
240374|NCT00408564|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when~     chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be~     resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug~     resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. Radiation therapy uses high-energy x-rays to kill tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin~     and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works~     in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be~     removed by surgery.~   "
240375|NCT00408551|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Internal radiation uses~     radioactive material placed directly into or near a tumor to kill tumor cells. Giving~     chemotherapy together with internal radiation may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving chemotherapy together with internal~     radiation works in treating patients with colorectal cancer that has spread to the liver.~   "
240376|NCT00408538|"~     This study is the first to try this product in the rectum of humans. This study is only to~     find out if the gel is safe for use in the rectum, not to see if the gel works. Information~     gathered from this study will help investigators decide whether this gel is safe enough to~     move onto the next phase of studies.~      Information gathered from this study will also help investigators determine what participants~     did and did not like about the product and what types of products people might want to use in~     the future. Currently condoms and abstinence are the only methods proven to prevent the~     spread of HIV sexually.~   "
240377|NCT00408525|"~     The purpose of the study is to examine patterns of brain activity in people who are at risk~     for memory problems (e.g., Alzheimer's disease or dementia)before and after the medication~     donepezil. Although genetic testing will be done, the results will not be shared with study~     participants.~      Once the genetic testing is completed subjects may continue to the second phase of the study.~     During this time they will be asked to take the medication donepezil (which is approved by~     the FDA for the treatment of Alzheimer's disease).~      Donepezil is not FDA approved for healthy volunteers and is therefore considered~     investigational in this study.~   "
242227|NCT00383916|"~     A study comparing 2 different investigational formulations of pantoprazole in healthy adults.~   "
240378|NCT00408512|"~     Background: The use of thiazide diuretics in the treatment of hypertension (HT) is widely~     considered a first line treatment, given the efficacy and low cost of this class of drugs.~     This indication is not unanimous, because thiazides can cause metabolic alterations and other~     side effects increasing cardiac and cerebrovascular risk, which reduce compliance to~     treatment and increase health care system cost. However, large intervention trials in HT~     suggest that the improvement in cardiovascular prognosis of HT patients depends more on~     follow-up procedures than on type of drug used. Furthermore, the investigators have~     documented improved compliance to antihypertensive therapy by implementing cooperation~     between general practitioners (GPs) and HT specialists.~      Objectives: In a multicenter, open label randomized study the investigators will compare the~     persistence on therapy of thiazides versus other treatments, as a first line antihypertensive~     therapy, in a clinical setting characterized by a strict cooperation between GPs and HT~     specialist. The investigators will also analyse candidate genes with impact on drug-induced~     metabolic alterations to elucidate the pathophysiology of these phenomena.~      Methods: 260 GPs will recruit 2600 hypertensive patients with indication to pharmacological~     treatment and randomise them to starting treatment with chlortalidone (12.5 to 25 mg daily,~     1300 pts) or a GP decided single drug (excluding thiazides) or combination therapy at highest~     tolerated dose. In both groups any other class of antihypertensive drugs can be added over~     time in order to achieve blood pressure control (<140/90 mmHg). Follow-up will last 2 years.~     Blood sample and urine analyses, carotid and cardiac ultrasound will be performed at baseline~     and scheduled time points. Genotyping will be performed by sequencing. Data will be collected~     and stored using a web based centralized Case Report Form (CRF) Expected results: Results~     will highlight whether a follow-up strategy based on tight cooperation between GPs and HT~     specialists can allow the use of thiazides as first line antihypertensive therapy without any~     negative effect on persistence, adherence and efficacy of the treatment. These data can be~     used to reduce total burden of the Health Care System in HT by replacing more expensive drugs~     with diuretics in the 50% of hypertensive patients, who do not receive this class of drugs.~     Furthermore, the pharmacogenetic approach may clarify the pathophysiological mechanisms of~     drug-induced metabolic side effects~   "
240379|NCT00408499|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Giving erlotinib together~     with cetuximab may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and~     cetuximab and to see how well they work in treating patients with advanced solid tumors or~     progressive or recurrent stage III or stage IV non-small cell lung cancer.~   "
240380|NCT00408473|"~     The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in~     the prevention of recurrent AF during 9 months of active treatment compared to placebo in~     patients with only one documented AF episode.~   "
240381|NCT00408460|"~     This phase II trial is studying how well giving imatinib mesylate together with paclitaxel~     works in treating older patients with stage IIIB or stage IV non-small cell lung cancer.~     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving imatinib mesylate together with paclitaxel may kill more tumor cells~   "
240382|NCT00408447|"~     The primary purpose of this study is to see if giving lower doses of chemotherapy (moderately~     ablative) will result in successful bone marrow replacement without as severe side-effects~     but with permanent control of the disease. Patients will receive a chemotherapy regimen with~     busulfan, fludarabine, and alemtuzumab followed by an infusion of stem cells, either from a~     family-related or cord-blood matched donor.~   "
240383|NCT00408434|"~     An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential~     cohorts of 3 to 6 patients with advanced or metastatic malignancies.~   "
240384|NCT00408421|"~     The primary purpose of this study is to determine if duloxetine reduces pain severity in~     patients with osteoarthritis knee pain.~   "
240385|NCT00408408|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood~     flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab~     after surgery may kill any tumor cells that remain after surgery. It is not yet known which~     chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying six different chemotherapy regimens to~     compare how well they work with or without bevacizumab in treating women with stage I, stage~     II, or stage IIIA breast cancer that can be removed by surgery.~   "
240386|NCT00408395|"~     This is a study of the safety and immunogenicity of three commercially available influenza~     vaccines in children.~   "
240387|NCT00408382|"~     To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of~     characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying~     coronary artery disease~   "
240388|NCT00408369|"~     To evaluate the prophylactic activity of orally administered DB289 against Plasmodium~     falciparum in non-immune healthy volunteers who are challenged by the bite of five P.~     falciparum-infected Anopheles stephensi mosquitoes~   "
240405|NCT00408135|"~     The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules)~     1g filling sachet in children with infections (Respiratory tract infections, Dermatological~     infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections).~      Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and~     acceptability of telithromycin (20% fine granules) 1g filling sachet in children with~     infections.~   "
240406|NCT00408122|"~     The aim of the study is to evaluate the diagnostic procedures emission tomography in~     combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative~     evaluation of resectability of patients with primary or secondary liver cancers.~   "
240415|NCT00408005|"~     This randomized phase III trial is studying different combination chemotherapy regimens and~     their side effects and comparing how well they work in treating young patients with newly~     diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more cancer cells. It is not yet known which combination chemotherapy regimen is~     more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic~     lymphoma.~   "
240389|NCT00408356|"~     Zinc deficiency has been found to be widespread among children in developing~     countries.Clinical and field studies have consistently observed an association between zinc~     deficiency and higher rates of infectious diseases, including skin infections, diarrhea,~     respiratory infections, malaria, and delayed wound healing. Based upon the impact of zinc~     deficiency on diarrheal disease alone, it is estimated correction of this deficiency could~     save 450,000 under-five deaths annually. What is the physiological explanation for this? Zinc~     has been identified to play critical roles in metallo-enzymes, poly-ribosomes, the cell~     membrane, and cellular function, leading to the understanding that it also plays a central~     role in cellular growth and in the function of the immune system. With zinc deficiency~     epithelial barriers are compromised and multiple components of the immune system malfunction.~     The obvious conclusion is that zinc deficiency results in diminished immunological competence~     that in turn leads to an increased risk for infectious diseases and greater severity of~     illnesses. Whether this is the case requires substantiation. A related, but more pragmatic~     question is the value added of zinc supplementation in addition to zinc treatment. The~     scale-up strategy being pursued in Bangladesh is to provide zinc for 10 days as a treatment~     at the time of a diarrhea episode. This is in accordance with recently revised WHO~     recommendations for the treatment of childhood diarrhea (WHO, in press). Can we conclude~     there is no or minimal value added to continuing zinc as a dietary supplement in zinc~     deficient children following an acute episode? If there is added benefit, can this be~     explained by improvement in zinc levels and/or immune function? The aims of this study~     include:1. In children six to twenty-four months of age with an acute episode of diarrhea~     attributable to enterotoxigenic E. coli (ETEC), to describe the innate and adaptive immune~     response to zinc and to relate changes in immune function or zinc status to the occurrence of~     repeat infectious illnesses over a 9 month period of observation. 2a. In children six to~     twenty-four months of age with an acute episode of diarrhea with enterotoxigenic E. coli~     (ETEC), and other non-ETEC diarrhea, to determine the value added of zinc supplementation~     following treatment in terms of the future occurrence of ACD, ARI, and impetigo and 2b. to~     assess the impact of zinc supplementation on health services utilization and household~     expenditures for ACD, ARI and impetigo.~   "
240390|NCT00408330|"~     This study is to determine whether a medication on the market for other indications is~     effective and safe in treating seborrheic dermatitis of the face.~   "
240391|NCT00408317|"~     The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to~     placebo for the correction of fat and protein malabsorption in participants with cystic~     fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis~     Pharma (formerly Axcan).~   "
240392|NCT00408304|"~     The purpose of the study is to check whether development of depression as a side effect of~     interferon alpha treatment in chronic carriers of hepatitis C can be prevented by omega-3~     fatty acids.~   "
240393|NCT00408291|"~     The purpose of this study is to study with the use of clinical and radiological parameters~     the treatment of three-part and four-part fractures with the Winsta PH osteosynthesis device~     (Fischer Medical).~   "
240394|NCT00408278|"~     Primary objectives~        -  To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for~          induction and consolidation therapy in patients with APL.~        -  To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and~          overall survival, as well as on the duration of remission and cumulative incidence of~          relapse in low- and intermediate-risk patients with APL.~        -  To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation~          for high-risk patients (administered as in the original GIMEMA protocols) on the~          event-free, disease-free, and overall survival, as well as on the duration of remission~          and cumulative incidence of relapse.~        -  To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy~          in the whole series and in each treatment group in patients with APL.~      Secondary objectives~      • To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.~   "
240395|NCT00408265|"~     The purpose of this study is to compare the effects of self-help materials for smoking~     cessation and self-help materials for smoking cessation plus prize-based contingency~     management (CM), in which prize incentives are available for breath and saliva samples that~     indicate smoking abstinence, in substance abuse treatment patients who want to quit smoking.~   "
240396|NCT00408252|"~     Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has~     antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So~     at the light of these pre-clinical and clinical data, it seems interesting and promising to~     test SU011248 in these poor prognosis patients.~   "
240397|NCT00408239|"~     Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing~     elective primary total knee replacement surgery~   "
240398|NCT00408226|"~     To determine the toxicities, maximum tolerated dose (MTD) and recommended phase 2 dose of~     MKC-1 when administered orally, twice daily for 14 days followed by 7 days without dosing, in~     combination with pemetrexed (delivered at its recommended single agent dose) to patients with~     advanced solid tumor malignancies. Also, to determine the antitumor activity, based on the~     objective response rate and median Progression Free Survival (PFS), of oral MKC-1,~     administered on this schedule in combination with pemetrexed to patients with non small cell~     lung cancer (NSCLC).~   "
240399|NCT00408213|"~     This 2 arm study will provide optional continuation of double-blind treatment with CellCept~     or placebo, in patients with myasthenia gravis who have achieved good symptom control in~     study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with~     stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with~     CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
240400|NCT00408200|"~     The purpose of this study is to examine the overall effectiveness of anti-arrhythmic~     medicines (to control heart rhythm) prescribed after an ablation procedure for atrial~     fibrillation.~   "
240401|NCT00408187|"~     The purpose of this study is to determine the safety and efficacy of voclosporin in patients~     with plaque psoriasis.~   "
240402|NCT00408174|"~     To establish the efficacy and safety of a new tablet formulation and dosing regimen of~     balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with~     mildly to moderately active ulcerative colitis after 6 weeks of therapy.~   "
240403|NCT00408161|"~     The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in~     reducing in-patient detoxification services for chronic recidivist alcohol-dependent~     patients.~   "
240404|NCT00408148|"~     The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to~     placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period.~      Primary objectives:~        -  To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR).~      Secondary objectives:~        -  To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other~          lipoprotein kinetics.~        -  To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters~        -  To assess effect of Rimonabant on body composition~        -  To assess safety of Rimonabant~   "
240407|NCT00408109|"~     This study will determine if an experimental avian flu (bird flu) vaccine is safe, whether it~     has side effects and if it can stimulate an immune response in people. The vaccine being~     tested in this study is made from DNA (genetic material) that codes for an influenza protein~     called hemagglutinin 5 (H5), which is based on the protein from the bird flu virus. The study~     will determine if the body creates resistance or immunity to the H5 protein. The hope is that~     an immune response to this protein may protect against bird flu virus infection.~      Healthy people between 18 and 60 years old who have been vaccinated with the current season's~     influenza vaccine may be eligible for this study.~      Participants are randomly assigned to receive injections of one of the following: 1) study~     vaccine at 1 mg dose, 2) study vaccine at 4 mg dose, or 3) placebo (salt-water solution).~     They receive three injections about 4 weeks apart in the upper arm muscle. Participants~     record their temperature and symptoms at home for 5 days after each injection, either on a~     diary card or electronically using the Internet, and report any side effects to a study~     physician or nurse as soon as possible. They return to NIH for clinic visits every 2 weeks~     for the first 12 weeks, then at week 26 and at week 42 to check for health changes or~     problems. Blood is drawn at all visits and urine samples are collected through week 10.~      If a participant develops serious side effects, the study physician may decide that he or she~     should not receive any further injections. However, all participants are asked to continue~     the follow-up visits even if they do not get the full set of three injections.~   "
240408|NCT00408096|"~     The purpose of this study is to determine whether there is a difference between the result of~     treatment of shoulder osteoarthritis with two different shoulder prostheses.~   "
240409|NCT00408083|"~     This is a double blind crossover study designed to compare two different gadolinium products~     given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation~     of peripheral steno-occlusive disease.~   "
240410|NCT00408070|"~     The primary objective is to determine whether the addition of bevacizumab to a regimen of~     carboplatin plus paclitaxel significantly improves Progression Free Survival (PFS) for~     patient with Stage III suboptimally cytoreduced or Stage IV ovarian, primary peritoneal or~     fallopian tube carcinomas.~   "
240411|NCT00408057|"~     This is a multi-center, open label observational study conducted over 26 weeks.~      Approximately 2,500 high-risk patients with an elevated LDL-C level (> 2.5 mmol/L) will be~     enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria~     at Visit 1 (Screening) will be included in the study. Eligible patients that agree to~     participate and sign an informed consent will be treated with either statin therapy~     (increased or started or switched) or combination of statin and ezetimibe 10 mg~     (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target~     of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient.~      After enrollment there are a total of three scheduled clinic visits. All patients will have~     vital signs measured as well as a brief physical examination performed at Visit 1~     (Screening).~      At Visit 2 (6 weeks) patients with LDL-C > 2.5mmol/L will be treated with either statin~     therapy increase or combination of statin and ezetimibe 10 mg (added/started) as per Study~     Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and~     providing that this treatment is in the best interest of the patient.~      At Visit 3 (12 -18 weeks) patients with LDL > 2.5 mmol/L will be treated with combination of~     statin and ezetimibe 10 mg as per Study Schematic (Table 1) in order to achieve the~     recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best~     interest of the patient.~      At final Visit 4 (24-26 weeks) safety and efficacy of treatment will be reviewed. Following~     Visit 4 physicians will continue to treat these patients according to their clinical~     judgment.~   "
240412|NCT00408044|"~     Chronic pain associated to sternotomy occurs in 40 to 50% of patients after cardiac surgery.~      33 to 66% of these patients suffer during 3 month and 25 to 33% have postoperative pain for~     at least 1 year.~      This pain has often negative effects on daily activity. Despite its frequency and importance,~     the etiology of this chronic pain is not completely understood.~      The goal of this study is to understand the mechanism of this chronic pain, to prevent and/or~     to treat better in the future.~      The sensitivity of the thorax after cardiac surgery seems to follow a dynamic evolution which~     can be observed within several weeks. Therefore we decided to study this evolution.~      This study is different from previous ones observing the sensitivity of the thorax at a well~     defined moment immediately after the surgery.~   "
240413|NCT00408031|"~     For many depression patients treatment changes are required, including switching to another~     antidepressant and addition of a second antidepressant or a non-antidepressant agent~     (augmentation). The need to modify treatment is usually necessary because of partial or no~     response to first-line monotherapy or the failure to achieve remission although treatment~     response (improvement) has been obtained. These caveats of presently available antidepressant~     drugs highlight the need for innovative pharmacological treatment strategies. Recent data~     suggest that N-methyl-D-aspartate receptor (NMDAR) antagonists and partial agonists at the~     NMDAR-associated glycine binding site may represent a novel type of antidepressant~     medications. These types of compounds protect vulnerable neurons against a variety of~     insults, including stress-induced damage, and may serve to enhance and maintain normal~     synaptic connectivity. In animal models, these compounds mimic the effects of clinically~     effective antidepressants. Furthermore, down-regulation of the glycine site of the NMDAR was~     found to be a common feature of currently used antidepressant medications. D-cycloserine (DCS~     , Seromycin) is a broad spectrum antibiotic, in use for over thirty years against~     tuberculosis, that acts as a partial agonist at the NMDAR-associated glycine site. Beneficial~     antidepressant effects have been reported with 500-1000 mg/day DCS regimens in depressed~     tuberculosis patients and recent preliminary findings suggest that DCS may also be beneficial~     in the treatment of major depressive disorder. The antidepressant effects of DCS seem to~     reflect consequences of its capacity to reduce NMDAR receptor function. In the present~     project, it is proposed to assess, using a random assignment, parallel-group, double blind,~     placebo controlled design, the effects of a NMDAR -antagonist DCS dose regimen, 250 --> 1000~     mg/day for 6 wks, as adjuvant pharmacotherapy for treatment-resistant major depressive~     disorder patients. The study methodology includes the assessment of DCS effects upon symptoms~     profile, neurocognitive tests performance, amino acids serum levels, and brain~     electrophysiology parameters associated with the prepulse inhibition-startle response~     paradigm. It is hypothesized that significant beneficial DCS treatment effects will be~     registered.~   "
240414|NCT00408018|"~     P276-00 is a molecule derived from Rohitukine, which through pre clinical assays was~     identified as a selective Cdk4-D1 and Cdk1-B inhibitor.The inhibition of these Cdks causes~     cell cycle arrest between the G1-S transition thus blocking the cell cycle events at an early~     stage of development. It therefore has the potential for being efficacious with lesser side~     effects.~   "
240416|NCT00407992|"~     The purpose of this study is to evaluate the safety and the efficacy of occipital nerve~     stimulation treating Chronic Migraine Headache~   "
240418|NCT00407966|"~     This phase II trial is studying the side effects and how well giving alvocidib together with~     cytarabine and mitoxantrone works in treating patients with newly diagnosed acute myeloid~     leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more cancer cells.~   "
240419|NCT00407940|"~     The rise of minimal access surgery has heralded the approval of a number of endovascular~     devices with similar indications. This is particularly true for the treatment of lower~     extremity ischemia. Comparable devices are selected for patient use somewhat arbitrarily,~     often dependent on industry influence. An unmet need is NON-industry sponsored prospective~     trials COMPARING devices head-to-head so that endovascular surgeons can even contemplate~     evidence-based device selection. At present, we seek to compare two new high-technology~     devices that are indicated to treat lower extremity arterial stenoses associated with~     claudication.~   "
240420|NCT00407927|"~     The purpose of this trial is to determine the safety, efficacy and tolerability of two doses~     of the study drug compared to placebo for the treatment of subjects with seasonal allergic~     rhinitis.~   "
240421|NCT00407914|"~     The purpose of this study is to compare the effectiveness of Aquamid and Restylane in~     aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety~     of Aquamid through 12 months after treatment.~      The study includes an extended follow up to 24 months.~   "
240422|NCT00407901|"~     The purpose of this research is to evaluate how accurately a proposed Functionality~     Assessment Questionnaire measures the differences between low-functioning and~     high-functioning visually challenged individuals who are legally blind.~   "
240423|NCT00407888|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,~     and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found~     in bone marrow or peripheral blood and may help the immune system recover from the side~     effects of chemotherapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Giving combination~     chemotherapy and filgrastim together with trastuzumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride,~     cyclophosphamide, and filgrastim together followed by paclitaxel albumin-stabilized~     nanoparticle formulation and trastuzumab works in treating patients with breast cancer~     previously treated with surgery~   "
240424|NCT00407875|"~     Purpose:~      The purpose of this trial is to compare two different treatment options for patients with low~     risk and low-tier intermediate risk prostate cancer. The two treatment arms being compared in~     this study are: (control arm) permanent interstitial prostate brachytherapy (PIPB) VERSUS~     (experimental arm) intensity modulated external beam radiation therapy (IMRT).~      Hypothesis:~      The acute and late toxicities experienced by patients in the experimental arm (IMRT) are not~     significantly worse then the toxicities experienced by patients in the control arm (PIPB).~   "
240425|NCT00407862|"~     Inhibition of RAS delays onset of diabetes in clinical studies. Preliminary evidence suggests~     that telmisartan may have unique metabolic properties compared to other ARB due to activation~     of PPARγ.~      This should be tested in comparison with an ARB that is metabolically neutral in already~     published studies.~      H0: Telmisartan is not different from Losartan with respect to metabolic and vascular~     effects.~      H1: Telmisartan is different from Losartan with respect to metabolic and vascular effects.~   "
240426|NCT00407849|"~     Phase I/II study with intravitreal triamcinolone acetonide microspheres(RETAAC)for treatment~     of diffuse diabetic macular edema unresponsive to laser photocoagulation. Study hypothesis is~     that single intravitreal injection of RETAAC is safe and efficient compared to conventional~     treatment. Fifty patients will participate in this study and will be randomized into~     treatment and observation groups. Efficacy will be evaluated by best corrected visual acuity~     and macular thickness measured by optic coherence tomography (OCT) after 12 months of~     treatment.~   "
240427|NCT00407836|"~     The hallmark of HIV infection and AIDS is the continuous attrition of CD4 T cells. One of the~     mechanisms that may account for the CD4 attrition , is autoimmunity against the CD4 T cells,~     caused by autologous immune cells. Vaccination against autoimmune reactive T cells has been~     successfully tried in animal models of autoimmune diseases and is now being tried in patients~     with Multiple Sclerosis. The purpose of the present study is to test this hypothesis in HIV~     infection. We will vaccinate HIV infected patients in whom specific autoimmune reactivity~     against CD4 is present , with their own CD4 reactive T cells. Following that, we shall study~     the patients and find out if the T cell vaccination caused a rise in CD4 T cell levels, and~     whether it influenced HIV viral load, as well as HIV and CD4 specific immunity.~   "
240428|NCT00407823|"~     The purpose of this study was to compare ACCM/PALS guidelines performed with and without~     central venous oxygen saturation monitoring on the morbidity and mortality rate of children~     with severe sepsis and septic shock.~   "
240429|NCT00407797|"~     The purpose of this study is to assess the clinical improvement by partial seizures~     reduction, safety and tolerability of subjects having partial epilepsy related to the~     adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED~     (Antiepileptic drugs).~   "
240430|NCT00407784|"~     This study aims to evaluate the diagnostic value of the Aldosterone-Renin Ratio (ARR)as a~     screening test for primary aldosteronism among hypertensives. The test characteristics will~     be studied. Furthermore, the effect of eplerenone, a selective aldosterone-receptor~     antagonist will be studied.~   "
240459|NCT00407407|"~     The primary purpose of this study is to determine the maximum tolerated dose and~     dose-limiting toxicities (DLTs) of weekly and every 3-weeks ABI-007 in combination with~     carboplatin (area under the curve [AUC]=6) in patients with ovarian cancer, primary~     peritoneal cancer, or fallopian tube cancer.~   "
240460|NCT00407394|"~     Background: The current Integrated management of childhood infections (IMCI) algorithm~     prescribes that children with wheeze and fast breathing presenting to first level health~     facilities are given antibiotics if they continue to have fast breathing after two doses of~     bronchodilator. The primary purpose of the algorithm is to prevent mortality due to bacterial~     pneumonia. However, an unknown proportion of children managed in this fashion will have a~     viral related wheezing illness or asthma rather than pneumonia. Although it is unlikely that~     wheezing syndromes are a significant cause of mortality for children in developing countries,~     these algorithms are likely to result in unnecessary administration of antibiotics as well as~     inadequate treatment of recurrent wheezing illness. We do not have clear evidence about~     whether antibiotics can be withheld in some categories of children with wheeze. It is clear~     that wheeze can occur in bacterial infection and in addition co-infection with virus and~     bacteria has been well demonstrated in several studies of pneumonia etiology in children.~     Although some studies have found that children with more severe disease or who are blood~     culture positive are more likely to be febrile at presentation, this sign is not sufficiently~     sensitive or specific to determine whether antibiotics should be administeredSetting: The~     study will be conducted in eight medical colleges situated in Lucknow, Nagpur, New Delhi,~     Mumbai, Chennai, Trivandrum, Vellore, and Chandigarh. Design: This will be a multicentric,~     randomized, double blind efficacy trial. . Hypothesis: The primary hypothesis is that the use~     of oral amoxycillin for three days would be as effective, in terms of clinical cure on day 4~     as compared to use of oral placeboMain objective: To compare the proportion of children aged~     2 to 59 months presenting with non-severe pneumonia with wheeze whose respiratory rate does~     not fall below the age specific cut-off after three doses of nebulized salbutamol, that~     achieve clinical cure on day 4 on 3 day of treatment with oral amoxycillin versus~     placebo.Inclusion criteria: Children aged 2-59 months with non-severe pneumonia based on WHO~     criteria of respiratory rate above the age specific cut-off, audible / ausculatory wheeze.~     Exclusion criteria: Children with severe disease, received any documented antibiotic~     treatment in the past 48 hours, diagnosed asthmatic on maintenance therapy, complicating~     acute non-pulmonary or chronic illness, known drug allergy, hospitalization in the past 2~     weeks, history of measles within the last month, known immunodeficiency disorder, prior~     enrollment in the study, residing in areas not accessible for follow-up or whose guardian~     refuses to consent for the study. Sample size: Has been calculated to test the null~     hypothesis. There will be 950 children in each arm. Thus each site is required to recruit a~     minimum of 225 cases over 18 months.~   "
240606|NCT00405470|"~     The purpose of this study is to determine whether this particular knee replacement is better~     than those already on the market. By participation, it will further refine the design of~     future total knee replacements and perhaps increase longevity.~   "
240431|NCT00407771|"~     -  The purpose of this study is to examine the effects of tirofiban on platelet function~          the Ultegra RPFA in diabetic patients undergoing elective coronary angioplasty and~          stenting already treated with high loading dose (600mg) clopidogrel.~        -  About 44 people will be in the study. The study duration is a single hospitalization~          period during which the angioplasty will be performed in addition to a 30-day post~          hospitalization follow-up period.~        -  Patients taking part in the study will be assigned by chance into two groups.~             -  Group 1: patients will be treated with the glycoprotein inhibitor, Tirofiban~               (25mcg/kg over 3 min bolus dose and 0.15 mcg/kg/hr for 12-24 hours), started~               immediately after insertion of the sheath.~             -  Group 2: patients will be treated with equivalent placebo~      All patients will be loaded with 600 mg clopidogrel at least 4 hours prior to scheduled~     intervention.~      All patients will have platelet function analyses at baseline and following treatment.~   "
240432|NCT00407758|"~     RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with~     persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.~   "
240433|NCT00407745|"~     The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with~     spinal cord injury compared to placebo (pill that contains no active medicine). This study~     will also evaluate the safety of pregabalin in this patient population.~   "
240434|NCT00407732|"~     The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that~     will assist patients with hepatitis C in overcoming barriers that prevent them from becoming~     appropriate candidates for interferon therapy.~   "
240435|NCT00407719|"~     The purpose of this study is to see if the drug bevacizumab is safe and effective to use for~     people with choroidal neovascularization (CNV). CNV is an eye condition where abnormal blood~     vessels grow in the part of the eye responsible for central (straight ahead) vision. The drug~     is produced using recombinant DNA technology and has been approved by the FDA for use in~     colon cancer. Although not yet approved for people with CNV, the FDA has given permission to~     use this drug in this study.~   "
240436|NCT00407706|"~     In our previous research, we have shown that women that have breast cancer have a population~     of lymphocytes that recognizes specific antigen and there cytoplasmic matrix goes through~     physical change a short time after exposure in vitro to the same antigen. This change can be~     measured by polarization changes of fluorescent light emitted by FDA (fluorescein diacetate)~     labeled cells. Further test that we performed showed that those differences are also shown in~     a benign situation that known as indicator for a high risk for developing breast cancer~     within 10-15 years. The incidence of the expression of these lymphocytes correlates with the~     histopathological picture as it is related in high risk for the developing the disease.~      In this work we will expand the scope of the procedure to early detection of the cancerous~     process in breast lesions by Fitzgibbon's risk categories for the development invasive~     carcinoma of the breast. In the proposed work we intend to use specific antigen MUC1 for~     breast cancer. This study is a continuation of our published work in the The Breast ~   "
240437|NCT00407693|"~     In this study we will examine where the radioactive tracer [11C]PBR28 is distributed in the~     body of healthy volunteers to calculate the radiation exposure to organs of the body. We will~     also test if [11C]PBR28 binds to your blood cells and compare with the binding in PET images.~   "
240438|NCT00407680|"~     To observe the effect of intensive medical treatment for type 2 diabetic patients with~     hypertension: to discover whether or not intensive medical treatment improves proteinuria,~     and the difference between the clinical meaning of responder and non-responder (criteria: 50%~     reduced proteinuria continuing 6 months or more during the observation period.)~   "
240439|NCT00407667|"~     Transcranial galvanic stimulation (tDCS) seems to promote motor recovery after stroke by~     stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment~     of severe arm paresis after stroke, robot-assisted arm training (AT) proved to be effective,~     but nevertheless only a few patients could use their affected hand functionally in daily life~     after robot training. Therefore the present study intends to combine both approaches, tDCS +~     AT, applied at the same time every day for six weeks. The study has three treatment arms, two~     groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned~     hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor~     area of the lesioned side directly, while the cathodal stimulation of the non-lesioned~     hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory~     inputs. The third group will receive a sham-stimulation. All patients will work with the AT~     simultaneously to the tDCS, respectively sham-tDCS.~   "
240440|NCT00407654|"~     This phase II trial is studying how well VEGF Trap works in treating patients with previously~     treated metastatic colorectal cancer. VEGF Trap may stop the growth of colorectal cancer by~     blocking blood flow to the tumor.~   "
240441|NCT00407641|"~     Low molecular weight heparin (LMWH) provides a safe and effective alternative to UFH for~     hemodialysis anticoagulation. While unfractionated (UF) heparin has been implicated in~     hyper-lipidemia, the effect of LMWHs on the lipid profile in non-diabetic patients on chronic~     hemodialysis remains controversial. The effect of LMWH in diabetic patients, a high risk~     group for developing hyper-lipidemia and cardio-vascular disease, has not been studied.~      The study intends to examine the long-term effects of the replacement of UFH by LMWH~     (tinzaparin sodium) on cardio-vascular outcomes and on lipoprotein profiles in a large group~     of diabetic patients stable on HD.~   "
240442|NCT00407628|"~     To investigate the relationship between the integrity of the white matter, including the~     corticospinal tracts and the corpus callosum, with the recovery of lower extremity function~     in patients with cerebral stroke at the subacute and chronic stages.~   "
240461|NCT00407381|"~     This study is being done to see if the investigational drug Ranibizumab (RBZ) given by~     injection into the eye, is safe and effective to use in people with diabetic macular edema~     (DME). The investigators want to compare RBZ to laser treatment which is the current standard~     way to treat DME.~      RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood~     vessels that cause loss of vision in patients with DME.~   "
242228|NCT00383903|"~     The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for~     concomitant administration with EPI vaccines to infants in South Africa.~   "
240443|NCT00407615|"~     This project is to assess the effectiveness of the use of magnets in reducing chronic lumbar~     pain. I understand that I will wear a flex pad (magnet) during waking hours and keep daily~     Visual Analog Scale (VAS) pain scores to determine if wearing this device will reduce my~     constant pain. I understand that there are no adverse side effects known from the use of~     these magnets other than irritation at the site. The identical inactive pads (sham/placebo)~     have been supplied for use as controls.~      I will be randomly assigned into one of two groups and I agree to remain blinded as to the~     specific type of device that I will receive, i.e. active vs. placebo. Dr. Weintraub~     (principal investigator) will remain blinded throughout the study. I also agree to not break~     the blind. Dr. Weintraub has stated that as a result of my cooperation and ability to~     complete the study, I will be guaranteed to either keep my specific device or receive a~     specific known active device gratis. This currently sells commercially for $60.~   "
240444|NCT00407602|"~     The objective of this feasibility study is to evaluate the safety and utility of the Argus II~     Retinal Stimulation System in providing visual function to blind subjects with severe to~     profound retinitis pigmentosa.~   "
240445|NCT00407589|"~     This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in~     participants with bacterial conjunctivitis. The purpose of this study is to determine the~     extent of systemic exposure to BOL-303224-A following single and multiple topical~     administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.~   "
240446|NCT00407576|"~     Alzheimer's disease is associated with accumulation in the brain of a protein called amyloid.~     The purpose of this study is to test the ability of a research drug to measure amyloid in~     brain using positron emission tomography (PET) and a research drug called [11C]MeS-IMPY.~   "
240447|NCT00407563|"~     The purpose of this study is to evaluate the effectiveness and tolerability of the~     combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian~     cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life~     is during their treatment.~   "
240448|NCT00407550|"~     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving pemetrexed disodium together with gemcitabine may kill more tumor~     cells.~      PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed~     disodium and gemcitabine to compare how well they work in treating patients with stage IIIB~     or stage IV non-small cell lung cancer.~   "
240449|NCT00407537|"~     To investigate whether a Caduet based treatment strategy might result in greater reduction in~     total cardiovascular risk as compared to usual care in subjects with hypertension and~     additional risk factors.~   "
240450|NCT00407524|"~     This study aims to provide scientific evidence of the efficacy and safety of this agent as~     'add-on' therapy for adult patients whose asthma remains uncontrolled on standard medication.~     The aims are to assess the efficacy, safety and tolerability of AKL 1 companred to placebo in~     the treatment of asthma.~   "
240451|NCT00407511|"~     Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic~     neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy~     induced peripheral neuropathy.~   "
240452|NCT00407498|"~     P276-00 is specific Cdk4-D1 and Cdk1-B inhibitor. P276-00 exhibited significant tumour~     reduction in animal models with less adverse effects.Based on the results from various~     in-vitro studies, P276-00 could be a potential candidate as a new mechanism based drug for~     the treatment of cancer.This Phase I study will determine the Maximum Tolerated Dose,Dose~     Limiting Toxicity and efficacy of P 276-00 in patients with advanced Refractory neoplasms.~   "
240453|NCT00407485|"~     This phase II trial is studying the side effects and how well VEGF Trap works in treating~     patients with recurrent, locally advanced, or metastatic cancer of the urothelium. VEGF Trap~     may stop the growth of tumor cells by blocking blood flow to the tumor.~   "
240454|NCT00407472|"~     This study was a Phase I, open label, randomized, 2-period, 2-sequence, crossover study~     designed to assess the relative bioavailability of Saizen administered by the ATS-1~     needle-free injection device and a standard needle and syringe. Informed consent was obtained~     prior to screening. All screening assessments establishing subject eligibility were performed~     in the 21 days before dosing. Randomization Pre-dose on Day 1, subjects were randomized to~     one of the two treatment sequences: Sequence 1: SC Saizen administered by the Standard needle~     and syringe (Period 1) followed by the administration using the ATS-1 device (Period 2).~     Sequence 2: SC Saizen administered by the ATS-1 device (Period 1) followed by administration~     using the standard needle and syringe (Period 2).~      Subjects were resident at the Unit from approximately 19:00 on Day -1 until Day 2~     (approximately 30 hours (h) post dose) of each treatment period. An IV Stilamin infusion was~     commenced 1 h before. Saizen administration and stopped immediately after the last~     pharmacokinetic (PK) blood sample has been taken, i.e. a 25 h infusion. Stilamin was~     administered as a constant IV infusion at a rate of approximately 118 mg/h (40 mL/h), which~     corresponds to 1.65 mg/kg body weight/h for a person weighing 70kg. Dosing with Saizen~     occurred between approximately 0800 and 0900 h on Day 1 of each treatment period after an~     overnight fast of at least 10h. Subjects were dosed with Saizen at the same time on Day 1 in~     Periods 1 and 2. There was a minimum of 7-day washout between treatment periods 1 and 2.~      Laboratory safety tests, ECGs were taken at protocol specified time points and blood samples~     for the assessment of glucose and growth hormone were taken immediately predose and 1, 2, 3,~     4 4.5, 5, 5.5, 6, 7, 8, 12, 18 and 24 h post dose. A post-study visit took place 33+/- 3 days~     after dosing a treatment period 2.~   "
240455|NCT00407459|"~     The primary objective is to assess antitumor activity of the combination of bevacizumab,~     pemetrexed and carboplatin, in terms of time to progression.~   "
240456|NCT00407446|"~     To test the hypothesis that long-term PDE5-inhibition by overexpressing the nitric oxide~     pathway is beneficial in chronic heart failure patients.~      Double-blind and placebo-controlled trial. Primary end-points: quality of life and exercise~     performance~   "
240457|NCT00407433|"~     These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in~     refractory or relapsing pediatric solid tumors.~   "
240458|NCT00407420|"~     We run a successful clinic in Bristol for children with severe obesity who already~     demonstrate many features to suggest they are at increased risk of early diabetes and heart~     disease. However, we have found that young children respond better to simple interventions~     than do adolescents. We have used a new treatment regimen Mandometer® to help our most~     difficult adolescent cases lose weight. We would like to do a study to see if all adolescents~     might improve weight loss using this technology compared to what we routinely offer~   "
240559|NCT00406081|"~     Atopic dermatitis (AD) causes people to be susceptible to skin infection and inflammations.~     The purpose of this study is to determine the immune response to chicken pox vaccine in~     children with or without AD who received the vaccine 2 to 16 weeks prior to the study visit.~   "
240462|NCT00407368|"~     The purpose of this study is to perform a prospective evaluation regarding the relationship~     between platelets function and cardiovascular events in patients with ESRD.~      The study will include 100-200 patients with ESRD, age 18 years or older, treated in the~     nephrology division of Assaf Harofeh medical center.~      The primary end points of the study are cardiovascular events including acute myocardial~     infarction (defined as symptoms + acute elevation of TnI), need for coronary artery disease~     revascularization, or acute cerebrovascular event (TIA or CVA) and mortality. The secondary~     end points are any hospitalization due to acute coronary syndrome, active bleeding with the~     need for blood transfusion and dialysis access graft thrombosis (time to thrombosis).~      Blood will be taken for complete blood count including platelets count and mean platelets~     volume, serum electrolytes, albumin, blood lipids, Kt/V, troponin and two 5 ml aliquots from~     each blood collection will be separated and stored at -70co until analyzed for oxidative~     stress, homocysteine and highly sensitive CRP will be performed. Five mL of blood will be~     sent for platelets function assessment.~      During the follow up period the correlation between platelets function an cardiovascular~     events will be assessed.~   "
240463|NCT00407355|"~     Central and branch retinal vein occlusions are major causes of visual loss. Hemorrhage and~     capillary nonperfusion, when they involve the macula, can contribute to visual loss, but the~     major cause is macular edema. Focal and grid laser photocoagulation can sometimes provide~     benefit in patients with macular edema due to branch vein occlusions, but several laser~     treatments are often needed and recovery of vision can be very slow and incomplete 1. Laser~     photocoagulation does not provide benefit for macular edema due to central vein occlusions 2.~     Therefore, new treatments are needed.The objective of this study is to assess the bioactivity~     of 3 intravitreous injections 0.5 mg or 0.3 mg of ranibizumab in patients with macular edema~     due to central and branch retinal vein occlusions and correlate activity with peak and trough~     aqueous levels. The purpose of this research protocol is pilot study to determine if a~     randomized placebo controlled trial is warranted.~   "
240464|NCT00407342|"~     Alefacept is a new anti-psoriatic drug within the group of the so-called biologics. In about~     30% of patients alefacept induces a more than 75% improvement of psoriasis after a 12-week~     treatment period. The start of anti-psoriatic effect by alefacept is delayed, however~     improvement of psoriatic lesions outlasts the end of alefacept treatment.~      Narrowband UVB (UVB-311nm) phototherapy is an established anti-psoriatic treatment regimen~     with rapid onset of anti-psoriatic efficacy but disease-free intervals after the end of~     successful treatment courses may be short.~      Therefore, in this half-side (left/right side) comparison study we aim to investigate whether~     an additional narrowband UVB treatment accelerates and improves the anti-psoriatic treatment~     effects of alefacept.~   "
240465|NCT00407329|"~     We hypothesize that the absolute or relative serum or urine levels of the urokinase~     plasminogen activator system, including uPA, uPAR and PAI-1,2 (inhibitors of the uPAR/uPA~     complex), are associated with inflammation in prostatic tissue.~   "
240466|NCT00407316|"~     The purpose of this study was to measure the quality of visual function and quality of daily~     living in patients with anterior, posterior, and panuveitis.~   "
240467|NCT00407303|"~     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow~     unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis~     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process~     of cell death that is often inhibited in cancer cells.~   "
240468|NCT00407290|"~     Perineal pain after childbirth occurs in the majority of women (with or without episiotomy).~     Perineal pain can become source of chronic pain in 9%-12% of the cases. Neostigmine a~     cholinesterase inhibitor at a dose of 500µg combined with Sufentanil or Ropivacaine (=local~     anaesthetic) is an analgesic. The goal of this study is to examine the effect of the use of~     epidural Neostigmine for perineal analgesia at the end of the labor on acute pain and on the~     development of chronic pain post partum.~   "
240469|NCT00407277|"~     Cigarette smoking decreases life expectancy, causes devastating health complications, and~     costs society billions of dollars each year. These untoward consequences are especially~     pronounced among persons with schizophrenia (SCZ) because approximately 80% to 95% of this~     group smokes cigarettes. These high prevalence rates underscore the need for research~     investigating the determinants of smoking in patients with SCZ. Several researchers have~     observed that nicotine improves specific symptoms of SCZ including negative symptoms,~     negative affect, and cognitive deficits. This has led to the hypothesis that patients with~     SCZ smoke in an attempt to self-medicate. However, the mechanism(s) by which nicotine has its~     positive effect on symptoms remains unclear. The current proposal posits that neural~     inhibition (NI) is a physiological mechanism of this effect, while variation in the~     alpha-7-nicotinic receptor subunit gene (CHRNA7) represents the genetic underpinnings of~     these processes. The proposed study will assess NI and symptom improvement after acute~     administration of nicotine to both smokers and nonsmokers with SCZ. In addition, NI and~     CHRNA7 variation will be tested as predictors of patients' ability to reduce/quit smoking~     following smoking treatment. These data may lead to the development of new pharmacological~     strategies for treating the symptoms of SCZ and new methods for assisting these patients to~     quit smoking.~   "
240470|NCT00407264|"~     The purpose of this study is to assess the efficacy of fluticasone on the development of lung~     cancer in smokers~   "
240471|NCT00407251|"~     The purpose of this study is to determine the efficacy of patupilone chemotherapy and to find~     out what effects (good and bad) the drug Patupilone has on patients with prostate cancer that~     has progressed following hormone treatment and docetaxel chemotherapy.~   "
240472|NCT00407238|"~     The purpose of this study is to evaluate the effect on epithelial barrier function of three~     emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during~     normal regimen use.~   "
240473|NCT00407225|"~     The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is~     effective in the treatment of postoperative inflammation.~   "
240474|NCT00407212|"~     This study will investigate the effect of TCH346 compared to placebo in delaying the need for~     symptomatic treatment with dopaminergic agents~   "
240618|NCT00405314|"~     The purpose of this study is to evaluate the effectiveness of continuous positive airway~     pressure ventilation when applied by paramedics to individuals with severe breathing~     difficulties in the prehospital setting.~   "
240475|NCT00407199|"~     This is a pilot study that will focus on the collection of preliminary data to determine the~     efficacy of quetiapine for individuals with social phobia. We hypothesize that individuals~     will react with less self-reported anxiety and physiological reactivity in the drug condition~     than in the placebo condition. If true, this would constitute a strong signal for a~     significant treatment effect for quetiapine in social phobia. A positive treatment effect in~     this study would provide rationale for further investigation of the efficacy of quetiapine~     for cue reactivity for individuals with social phobia. Further study would include increased~     sample size in order to obtain statistical power and replication of findings. We will utilize~     the IR formulation of quetiapine.~   "
240476|NCT00407186|"~     The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and~     radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for~     gastric cancer. Prior to surgery all patients will receive neo-adjuvant chemotherapy as well.~   "
240477|NCT00407173|"~     This study is an open-label, single-dose, parallel group study to evaluate the effects of age~     and gender on the pharmacokinetics, safety, and tolerability of HCV-796 administered orally~     to healthy subjects.~   "
240478|NCT00407160|"~     Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin~     induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.~   "
240479|NCT00407147|"~     The purpose of this study is to test whether a U.S. Food and Drug Administration (FDA)~     approved laboratory test (PCT Kryptor) can help doctors make better decisions on the need for~     antibiotic therapy in ICU patients with suspected infections.~   "
240480|NCT00407134|"~     Subjects with peritoneal dialysis are randomized to different groups. The different groups~     receive different intra-abdominal volumes and different glucose-concentrations.~      The effects on blood pressure and other cardiovascular parameters (e.g. central blood~     pressure, augmentation index, ...) will be evaluated.~   "
240481|NCT00407121|"~     Intravitreal injection of Bevacizumab in patients with Neovascular Membranes secondary to~     intraocular inflammation. We injected a single injection of Bevacizumab (2.5 mg/0.1 ml) and~     evaluate visual acuity , Fluorescein angiogram and retinal thickness by Optical Coherence~     Tomography (OCT) in 4 patients with Vogt Koyanagi Harada disease, 1 patient with Serpiginous~     Choroidopathy and 1 patient with Multifocal Choroiditis.~   "
240482|NCT00407108|"~     To investigate the feasibility and advantages of using perfluorocarbon liquid (PCL) perfusion~     to remove vitreous during suction-cutting vitrectomy using a dual, dynamic drive~     (3D)technology. In complicated surgeries in advanced diabetic retinopathy and retinal~     detachment~   "
240483|NCT00407095|"~     This study is a multicenter, 9 months, open label extension study for all patients who are~     willing and eligible to continue from the pivotal, double-blind S308.3.002 study.~   "
240484|NCT00407082|"~     This is a multi-center, randomized, double-masked, controlled study to evaluate the safety~     and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of~     subjects with non-infectious uveitis affecting the posterior segment of the eye. An~     additional objective is to compare the safety and efficacy of two doses of fluocinolone~     acetonide.~   "
240485|NCT00407069|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by recurrent~     viral skin infections. Recent studies have demonstrated that the skin of people with AD my~     have decreased antimicrobial peptide (AMP) expression. The purpose of this study is to~     compare smallpox virus replication and the number of AMPs and other antiviral molecules in~     people with AD, as compared to those seen in people with psoriasis or asthma, or healthy~     individuals.~   "
240486|NCT00407056|"~     The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic~     emulsion is effective in the treatment of severe uveitis.~   "
240487|NCT00407043|"~     To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry~     eye.~      It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the~     stinging with cyclosporine administration and the dry eye signs and symptoms experienced~     during the initiation of therapy.~   "
240488|NCT00407030|"~     At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all~     patients who entered the extension period were treated with up to five injection sessions of~     incobotulinumtoxinA (Xeomin) during the extension period.~   "
240489|NCT00407017|"~     The purpose of this study is to compare patient outcomes in following cataract surgery in~     patients randomized to one of two surgical kits.~   "
240490|NCT00407004|"~     This trial compares the efficacy of two artificial liver support systems, MARS (Molecular~     Adsorbents Recirculating System) and Prometheus (FPSA, Fractionated Plasma Separation and~     Adsorption), in removing albumin-bound substances such as bilirubin, bile acids, and~     cytokines.~   "
240491|NCT00406991|"~     The project aims to find mechanisms for the abnormal retinal blood flow that in diabetic~     patients often precedes any evidence of clinical retinopathy and may contribute to the~     development of retinopathy.~      Specifically, the projects tests the hypothesis that reduced retinal blood flow found in~     young patients with type 1 diabetes reflects increased resistance in the small vessels of the~     retina caused by the formation of small blood clots, called microthrombi; and that~     antiplatelet agents normalize the reduced retinal blood flow.~   "
240492|NCT00406978|"~     This study will evaluate the safety and the efficacy of the association of Melphalan/~     Prednisone/Thalidomide/Defibrotide (MPTD) as salvage treatment in advanced and refractory~     myeloma patients. This association might further increase the response rate achieved by oral~     MPT regimen~   "
240493|NCT00406965|"~     This is a Phase II, multicenter, randomized, double blind, placebo controlled, multiple-dose~     study designed to evaluate the efficacy, safety, and tolerability of subcutaneously~     administered HAE1 in subjects 12-75 years old with moderate to severe asthma whose symptoms~     are inadequately controlled with moderate to high-dose ICS and LABA.~   "
240494|NCT00406952|"~     Purpose of the study is to evaluate use of electronic diaries and voice acoustics for use in~     future depression clinical trial. Focus is on increased precision of measurement.~   "
240619|NCT00405301|"~     Purpose of the study is to evaluate the safety and efficacy of different re-introduction~     regimens in anti-TB drug induced liver damage. There is no consensus how best to treat such~     patients who developed drug induced liver damage.~   "
240495|NCT00406939|"~     This study is designed to determine the safety of IL-12 gene therapy for patients with~     recurrence of prostate cancer after radiation therapy and those with or without metastatic~     disease with a prostate gland intact. These, of course, would include recurrent prostate~     cancer after definitive radiation therapy. The prostate cancer will be treated with a~     prostatic injection of a replication-defective adenovirus vector delivering the IL-12 gene.~     Following virus injection, patients will be hospitalized for 23 hours for observation. Only~     one course of therapy will be administered. Each patient will be carefully monitored for~     toxic effects. Three to five patients will be tested with a low dose of virus and if there~     are no serious adverse side effects, the dose will be slowly escalated in subsequent groups~     of 3-5 patients or until unacceptable toxicity is reached. Effectiveness will be monitored by~     serum prostate-specific antigen (PSA), transrectal ultrasound of the prostate, prostate~     biopsy and comparison of survival times to historical survival times for patients with~     radiation recurrent prostate tumors. The primary objective of this initial study is to~     determine whether the treatment is associated with significant toxicity.~   "
240496|NCT00406926|"~     This study investigated the effect of growth hormone on the growth of infants and toddlers~     with Turner syndrome during 2 years of treatment with growth hormone. This was compared with~     the growth of infants and toddlers with Turner syndrome who did not receive any growth~     hormone treatment. The overall aim was to prevent the growth failure usually seen during this~     period. The study also looked at middle ear disease, hearing problems, and cognitive and~     behavioral development.~   "
240497|NCT00406913|"~     The purpose of this study is to evaluate the conjunctival flora prior to cataract or~     vitrectomy surgery comparing mupirocin ointment applied to the conjunctiva along with~     standard ocular sterilization vs. standard ocular sterilization alone.~   "
240498|NCT00406900|"~     Uveal Melanoma is the most common primary intraocular tumor in adults. Most tumors~     metastasize to the liver. So far no sensitive or specific serological tumor marker is~     routinely used. The marker Melanoma inhibitory activity is a promising marker. Study~     hypothesis is to detect metastatic lesions in an early stage. This would increase life~     expectance of our patients~   "
240499|NCT00406887|"~     The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic~     emulsion is effective in the treatment of treatment of uveitis.~   "
240500|NCT00406874|"~     This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid~     on sperm quality and sexual function in infertile men. It will also evaluate the effects on~     sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects~     continuing on both omega 3 fats and folic acid.~   "
240501|NCT00406861|"~     Objective of the trial is to assess the safety and efficacy of Montelukast in treatment of~     Erythema Nodosum leprosum (ENL) reaction in multibacillary leprosy patients either in~     combination with prednisolone or alone.~      Hypothesis is that montelukast will reduce the severity of ENL reaction in Multibacillary~     leprosy patients without causing an unacceptably high incidence of adverse effects.~      Design is a multicentre hospital-based single-blind prospective trial for leprosy patients~     with ENL reaction. prior written consent will be taken from the patients who will undergo the~     trial.~      Endpoints are decrease in severity of ENL and absence of new nerve function impairment~   "
240502|NCT00406848|"~     The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once~     daily to placebo on depression in elderly patients (greater than or equal to 65 years of~     age). Patients who do not respond in the first 13 weeks will be eligible for rescue using~     pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria~     will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue~     criteria will be assigned to duloxetine 60 mg/day.~   "
240503|NCT00406835|"~     The purpose of this study is to determine if WBRT combined with SRS resulted in improvements~     in survival, brain tumor control, functional preservation rate, and frequency of neurologic~     death.~   "
240504|NCT00406822|"~     The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective~     and safe to implant as an aid of glaucoma surgery.~   "
240505|NCT00406809|"~     The Phase 1 portion of the study evaluated the pharmacokinetic profile and safety of ABT-263~     with the objective of defining the dose limiting toxicity and maximum tolerated dose in~     subjects with lymphoid malignancies. The Phase 2a portion of the study is evaluating ABT-263~     using a step-up dosing regimen and may be increased to the defined recommended Phase 2 dose~     to obtain additional safety information and a preliminary assessment of efficacy in subject~     with lymphoid malignancies. The Extension portion of the study is to allow Phase 2a subjects~     who remain active 1 year after the last subject enrolls or who have been on study~     approximately 1 year to continue receiving ABT-263 with less frequent study evaluations.~     Subjects in the Extension Study will continue receiving study drug for up to 7 years after~     the last subject transitions to the Extension Study, or until disease progression or toxicity~     that necessitates discontinuation (whichever comes first).~   "
240506|NCT00406796|"~     The purpose of this study is to determine whether ranibizumab will be effective in reducing~     if not eliminating the macular edema associated with the disease, central retinal vein~     occlusion (CRVO).~   "
240507|NCT00406783|"~     This study will investigate the effectiveness of desloratadine in treating subjects with~     allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.~   "
240508|NCT00406770|"~     The study investigates whether bright artificial light adds to hypocaloric diet to lose~     weight in obese subjects.~   "
240509|NCT00406757|"~     In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small~     patient population. While the small number of patients presents a practical limitation to the~     size of a clinical trial, patients whose disease has not responded to or has relapsed after~     treatment with multiple prior chemotherapy regimens have no accepted standard therapies~     available. Japanese leukemia experts have expressed interest in evaluating 506U78 in Japanese~     patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety, tolerability,~     and pharmacokinetic data of 506U78 in Japanese patients, this study is designed to maximize~     the contribution of each available patient.~   "
240620|NCT00405288|"~     The purpose of this study is to evaluate the fetal safety of topical application of~     Proctofoam-HC®, an antihemorrhoidal, in the third trimester of pregnancy.~   "
240510|NCT00406744|"~     Choroidal neovascularization is a leading cause of visual loss in people older than 60 years~     and for its treatment there had been performed multicentric studies with Lucentis~     (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated~     efficacy of bevacizumab in several pathologies but we dont know what would be the results if~     we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab~     for improve or stabilize visual acuity with two or more intravitreal inyections of~     bevacizumab.~   "
240511|NCT00406731|"~     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in~     perfusion pressure. The existence of an effective autoregulation in the optic nerve~     circulation has been shown in animals and humans. The exact mechanism behind this~     autoregulation is still unknown. The motive for the investigation of optic nerve head (ONH)~     blood flow autoregulation is to enhance the understanding of pathologic eye conditions~     associated with ocular vascular disorders. To clarify the regulatory mechanisms of ONH~     microcirculation is of critical importance to understand the pathophysiology of glaucoma~     because there is evidence that glaucoma is associated with optic nerve head ischemia. Several~     studies indicate that a disturbed autoregulation might contribute to glaucomatous optic~     neuropathy. Previous findings suggest endothelial dysfunction in glaucomatous optic~     neuropathy, in particular alterations in endothelin- and nitric oxide- system, which both~     play an important role in local regulation of vascular tone.~      In the present study, changes in ocular perfusion pressure will be performed during~     administration of drugs, which may potentially alter the pressure-flow relationship. These~     drugs include endothelin-1 and the nitric oxide synthase inhibitor NG-monomethyl-L-arginine~     (L-NMMA).~   "
240512|NCT00406718|"~     This study will determine the comparative effectiveness of two systems designed to improve~     medication adherence in people with schizophrenia.~   "
240513|NCT00406705|"~     The purpose of this study is to examine whether breathing helium-hyperoxia during exercise in~     a pulmonary rehabilitation program can improve the exercise tolerance and health related~     quality of life of patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
240514|NCT00406692|"~     In this study the influence of zonisamide administration over a 13 week period on alcohol~     consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of~     zonisamide given to subjects will be slowly increased over a period of several weeks. They~     will receive a full dose over a 5 week period. This will be a pilot study in which all of the~     subjects will only receive zonisamide. A primary objective of this study is to determine the~     possible size of the effect that zonisamide administration has on drinking (i.e. drinks~     consumed per day) to allow us to plan for a larger clinical trial of the effects of~     zonisamide on alcohol dependence.~   "
240515|NCT00406679|"~     The aim of the study is to evaluate the therapeutic efficacy and safety of two different~     paracetamol-containing solutions in postoperative dental pain. They will be compared to~     placebo (a dummy treatment which contains no active ingredient).~   "
240516|NCT00406653|"~     The purpose of this clinical research study is to learn if abatacept can improve signs and~     symptoms of active Crohn's Disease in patients who have not had an adequate response to other~     therapies. The safety of this treatment will also be studied.~   "
240517|NCT00406640|"~     Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine~     reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability~     of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are~     postmenopausal.~   "
240518|NCT00406627|"~     The purpose of this study is to check blood samples for lymphatic filariasis to determine~     whether the recent Program to Eliminate Lymphatic Filariasis was successful in controlling~     lymphatic filariasis in areas of Egypt. Volunteers will participate in a health assessment~     program carried out by Ain Shams University and approved by the Egyptian Ministry of Health~     and Population. This program includes a brief interview and laboratory tests to detect worm~     parasites in participants' blood. Volunteers and family members found to have worms in their~     blood will be referred for treatment. This study will provide early detection of this~     parasitic infection and referral for prompt treatment in order to prevent spread of the~     infection to others. Approximately 23,500 people, 6 years of age and older, will participate~     per year. Study participants will include people living in areas of Egypt that are known to~     have the filariasis parasite. Volunteers will participate for up to 2 years.~   "
240519|NCT00406614|"~     Many Korean Americans are at risk for developing high blood pressure. Low health literacy~     levels may play a role in this risk. The purpose of this study is to evaluate a~     literacy-focused program aimed at reducing blood pressure levels in older Korean Americans.~   "
240520|NCT00406601|"~     The aim of this study (*) is to evaluate the progression free survival rate at 6 months,~     response rate, overall disease control rate, overall survival of BAY-43-9006 in soft tissue~     sarcoma patients.~      (*) as per Protocol Amendment No. 1 of 16 April 2007 approved by local IEC on 24 July 2007~   "
240521|NCT00406588|"~     This study is a multicenter, randomized, double blind, parallel group study of 3 months'~     treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An~     open label safety extension to this study is planned as a separate protocol for patients who~     are willing and eligible to participate.~   "
240522|NCT00406575|"~     Two doses of relaxin will be compared to placebo for the treatment of patients with~     decompensated CHF~   "
240523|NCT00406562|"~     This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals'~     dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.~   "
240524|NCT00406549|"~     To establish the clinical test performance characteristics of sensitivity, specificity and~     predictive values for direct detection of nasal Staphylococcus aureus colonization against~     clinical microbiology laboratory culture methods.~   "
240525|NCT00406536|"~     The purpose of this phase II research study is to evaluate the effectiveness of the next~     generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for~     children and adolescents with Cystic Fibrosis (CF) and pancreatic insufficiency (PI).~   "
240560|NCT00406068|"~     The purpose of this study is to determine the efficacy and safety of intravesical~     Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional~     cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high~     risk of progression who are refractory to therapy with bacillus Calmette-Guerin (BCG).~   "
240526|NCT00406523|"~     Janus stent is the only marketed drug-eluting stent (DES) without polymer coating as yet in~     China. The goal of this study is to evaluate the efficacy of JANUS (Tacrolimus eluted stent)~     in inhibiting of restenosis in percutaneous coronary intervention (PCI) real world and to~     observe the safety and efficacy of 4 months’clopidogrel treatment after implantation of JANUS~     stent.~      Patients were enrolled and randomized to be treated by JANUS or SRNCRO (bare metal stent with~     the same platform as JANUS). All enrolled patients received daily clopidogrel for 4 months~     and aspirin for life long for post-PCI period(In AMI group, patients received daily~     clopidogrel 150mg for 2 weeks at first). The primary endpoints included death of heart,~     myocardial infarction, revascularization of the target lesson, sub-acute and late stent~     thrombosis one year after PCI, The secondary endpoints included MACE at 30 days, 6 months and~     restenosis by follow-up angiogram at 6 to 12 months.~   "
240527|NCT00406510|"~     The purpose of this study is subjectively compare duration of action between Optive and~     Systane.~   "
240528|NCT00406497|"~     The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is~     effective in the treatment of postoperative inflammation.~   "
240529|NCT00406484|"~     A randomized clinical trial to compare the efficacy of Behavioral Drug and HIV Risk Reduction~     Counseling (BDRC) and standard methadone drug counseling.~   "
240530|NCT00406471|"~     The RAVE (Rubeosis Anit-VEgf) trial, utilizes monthly intravitreal Ranibizumab (Lucentis)~     injections for 9 months to see if total VEGF blockade will prevent neovascular glaucoma and~     eliminate the need for panretinal photocoagulation in patients with ischemic central retinal~     vein occlusion.~   "
240531|NCT00406458|"~     The purpose of the study is to study the clinical effects of the investigational drug, SB-509~     versus placebo in patients with diabetic neuropathy.~   "
240532|NCT00406445|"~     This study will examine metabolic and biological factors in people with Li-Fraumeni syndrome,~     a rare hereditary disorder that greatly increases a person's susceptibility to cancer.~     Patients have a mutation in the p53 tumor suppressor gene, which normally helps control cell~     growth. This gene may control metabolism as well as cancer susceptibility, and the study~     findings may help improve our understanding of not only cancer but also other conditions,~     such as cardiovascular function.~      Healthy normal volunteers and patients with the Li-Fraumeni syndrome and their family members~     may be eligible for this study. Candidates must be at least 18 years of age, in overall good~     health and cancer-free within 1 year of entering the study. Participants undergo the~     following procedures:~        -  Blood tests for routine lab values and for research purposes.~        -  ECG and echocardiogram (heart ultrasound) to evaluate heart structure and function.~        -  Resting and exercise metabolic stress testing: The subject first relaxes in a chair~          wearing the facemask and then exercises on a stationary bicycle or treadmill while~          wearing the mask. This test uses the facemask to measure oxygen usage by the body to~          determine metabolic fitness. Electrodes are placed on the body to monitor the heart in~          an identical manner to a standard exercise stress test.~        -  Magnetic resonance imaging of metabolism: The subject lies on a bed that slides into a~          large magnet (the MRI scanner) for up to 60 minutes. During scanning, the arm or leg~          muscles are stressed by inflating a blood pressure cuff and by exercising the limb for~          several minutes. Subjects may be asked to squeeze a rubber ball or exercise with a foot~          pedal. Immediately afterwards, the pressure in the cuff is released and remains deflated~          for 10 to 15 minutes. No more than three 5-minute episodes of blood flow stoppage are~          performed.~        -  Standard MRI scan of exercised limb to determine muscle volume.~        -  Brachial artery reactivity test to measure blood vessel function: Before the exercise~          stress testing, subjects lie on a stretcher while the brachial artery (artery in the~          forearm) is imaged using a noninvasive ultrasound method. Artery size and blood flow~          velocity are measured before and after inflating a blood pressure cuff on the forearm.~          Vessel size and flow velocity measurements are repeated after 15 minutes and again after~          administration of nitroglycerin under the tongue.~        -  Oral glucose tolerance testing to test for diabetes: To assess sugar metabolism,~          subjects drink a sugar solution. Blood samples are collected before drinking the~          solution and 1 and 2 hours after drinking the solution.~        -  Muscle biopsy (optional according to subject preference): Subjects may be given small~          amounts of sedation for the procedure. A small area of skin over a leg muscle is numbed~          and a small amount of muscle tissue is surgically removed.~   "
240533|NCT00406432|"~     The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after~     14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy~     Chinese subjects.~   "
240534|NCT00406419|"~     This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in~     combination with methotrexate in patients with active rheumatoid arthritis who have had an~     inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of~     intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of~     i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg -~     25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment~     is 1-2 years. Target sample size is 1000.~   "
240535|NCT00406406|"~     Safety and tolerability of SKI-606 in healthy subjects; the influence of food intake on the~     same.~   "
240536|NCT00406393|"~     The study is designed as a phase III, randomized, open label, multicenter, prospective,~     comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as~     graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched,~     related, peripheral blood stem cell transplantation in individuals with hematologic cancer.~     Participants will be stratified by transplant center and will be randomly assigned to the~     sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.~   "
240537|NCT00406380|"~     Evaluation of efficacy of Intravitreal Injection of Bevacizumab in patients with Yuxtafoveal~     Telangiectasias~   "
240538|NCT00406367|"~     Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline.~     Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to~     five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.~   "
240539|NCT00406354|"~     A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to~     compare the efficacy and safety of atomoxetine versus placebo in children and adolescents~     aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid~     oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an~     initial 3- to 28-day screening and washout phase, participants will be assigned to~     double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be~     succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will~     be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.~   "
240540|NCT00406341|"~     The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is~     effective in the treatment of postoperative inflammation.~   "
240541|NCT00406315|"~     The primary objective of this study is to evaluate change in weight as a result of switching~     from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder~     who have failed to achieve a satisfactory clinical response to quetiapine due to lack of~     efficacy or poor tolerability.~   "
240542|NCT00406302|"~     Primary objective is to assess the overall response rate (ORR) after induction therapy with~     docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and~     IIIa. ORR will be determined by the percentage of patients achieving objective response rates~     (CR + PR) according to the RECIST guidelines.~   "
240543|NCT00406289|"~     This study will evaluate the feasibility of higher and prolonged dose escalation concentrated~     in the intra-tumoral regions which are FDG-avid after two weeks of radiotherapy.~   "
240544|NCT00406276|"~     This is an open-label, single-arm, Phase I/II trial to determine the safety of RAD001 in~     combination with docetaxel and compare the efficacy of RAD001 plus docetaxel versus published~     Phase II and III reports of docetaxel alone in patients with recurrent NSCLC.~   "
240545|NCT00406263|"~     Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for~     many years The mechanism for the rapid progression of nuclear sclerotic cataract remains~     unclear. The objective of this trial is to evaluate and compare the level and progression of~     cataract advancement in controls versus eyes that have undergone 20-gauge pars plana~     vitrectomy and 25-gauge pars plana vitrectomy.~   "
240546|NCT00406250|"~     The purpose of this study is to investigate the safety and efficacy of intravitreal~     bevacizumab in patients with choroidal neovascularization associated with angioid streaks.~   "
240547|NCT00406237|"~     Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with~     primary biliary cirrhosis (PBC)~   "
242229|NCT00383890|"~     The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus~     placebo used for sedation during elective awake fiberoptic intubation.~   "
240548|NCT00406224|"~     Background It has recently been shown that diffuse luminance flicker increases retinal and~     optic nerve head blood flow. This indicates that a neuro-vascular coupling between neural~     activity and blood flow exists as described previously for the brain. Although a lot of~     mediators such as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling~     is still a matter of controversy. However, it has been shown in an animal experiment, that an~     increase in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by an~     decrease in pO2 in the tissue. Thus, in this study we set out to investigate the flicker~     light induced increase in blood flow under elevated blood pO2.~      Study rationale The motive for the investigation of retinal blood flow regulation is to~     enhance our understanding of the coupling mechanism between increased neural activity and~     blood flow in the retina in order to gain new insight in the pathophysiology of several eye~     diseases associated with ocular vascular disorders Study objectives To test the hypothesis~     whether oxygen breathing influences flicker light induced changes in optic nerve head blood~     flow~   "
240549|NCT00406211|"~     Follow-up to evaluate the immunogenicity and safety of three production lots of GSK~     Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second~     year of life, as compared to separate administration of GSK Biologicals'~     measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany &~     Austria. Blood samples were collected at three time points during the follow-up period (Year~     1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.~   "
240550|NCT00406198|"~     The impact of continuous veno-venous haemofiltration (CVVH) on sepsis-induced multiple organ~     failure severity is controversial. We thus sought to assess the effect of early application~     of haemofiltration on the degree of organ dysfunction and plasma cytokine levels in patients~     with severe sepsis or septic shock.~   "
240551|NCT00406185|"~     The purpose of the registry is to collect and analyze clinical and laboratory data and tissue~     samples from patients who are diagnosed with any type of heart disease and to collect the~     same information and samples from healthy controls in participating Intermountain Healthcare~     facilities.~   "
240552|NCT00406172|"~     To report safety and efficacy of intravitreal injection of bevacizumab in patients with~     cystoid macular edema secondary to cataract surgery.~   "
240553|NCT00406159|"~     PURPOSE~      The purpose of this investigation is to evaluate the cognitive and behavioral effects of~     Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism spectrum~     disorder.~      HYPOTHESIS~        1. Hyperbaric Oxygenation Therapy will be safe to use with children with autism.~        2. Hyperbaric Oxygenation Therapy will have a statistically significant effect on the~          symptoms of autism.~        3. Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on~          the overt symptoms of autism.~        4. The decreases in the symptoms of autism will correlate positively with the number of~          Hyperbaric Oxygenation Therapy sessions.~        5. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at~          follow-up, post 40 treatment sessions.~      SPECIFIC AIMS~        1. Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children~          with autism.~        2. To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and~          cognitive symptoms of autism before, during, and after treatment.~        3. Identify number of treatments required to reach therapeutic effects.~        4. Identify the length and durability of treatment effect and maintenance.~   "
240554|NCT00406146|"~     Artemisinin combination therapies (ACT) are currently recommended for malaria treatment.~     Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly~     adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial~     treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date.~     Moreover, the safety of repeated treatments with ACT has been little studied. This study aims~     to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of~     these regimens in a longitudinal trial in which recruited children will be followed up for 1~     year.~   "
240555|NCT00406133|"~     Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0%~     in 3 age groups (>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring~     (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A~     parallel randomized trial is being conducted for a second cohort with HbA1c <7.0% that will~     follow an identical protocol to that of the first cohort with HbA1c >=7.0%.~      The >=7.0% trial was specifically designed and statistically powered to compare separately~     the impact of continuous versus standard intensive glucose monitoring in the three age~     groups. Both trials used standardized treatment algorithms and equivalent frequent contacts~     with subjects in both the CGM and control group.~      After completion of the 26-week trial, the CGM group continues to use CGM for another 26~     weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with~     longer-term use and less intensive contact and the control group initiates CGM use with less~     intensive contact after the first month than was provided at initiation of CGM use in the CGM~     group in the randomized trial.~   "
240556|NCT00406120|"~     Up to half of patients with ocular melanoma (also called iris, choroidal or uveal melanoma)~     develop metastasis. We have found that certain molecular features of the eye tumor can be~     detected by gene expression profiling and accurately predict which patients will develop~     metastasis. This molecular test could eventually allow high risk patients to receive~     preventative therapy to delay or prevent the development of metastasis. The goal of this~     study is to prospectively validate the predictive accuracy of the gene expression-based~     molecular test and compare it to monosomy 3, the most common but potentially less accurate~     molecular marker for metastasis in ocular melanoma.~   "
240557|NCT00406107|"~     The purpose of this study is to evaluate the effect of intravitreal injections of Macugen~     every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion~     (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that~     chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.~   "
240558|NCT00406094|"~     The purpose of this trial is to determine if patients with NARES treated with montelukast~     (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.~   "
240753|NCT00403520|"~     The purpose of this study is to demonstrate that donepezil slows the progression of~     Alzheimer's disease (AD) using magnetic resonance imaging (MRI) of the brain to measure the~     volume of the hippocampus in patients with pre-dementia Alzheimer's disease.~   "
240561|NCT00406055|"~     The purposes of this study is to 1) Provide additional information that the commercially~     available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used~     successfully by a wide range of physicians under commercial use conditions. 2) Provide an~     ongoing post-market surveillance mechanism for documentation of clinical outcomes and for~     possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a~     broader group of patients.~   "
240562|NCT00406042|"~     To evaluate whether or not using topical steroids after selective laser trabeculoplasty~     affects intraocular pressure outcomes.~   "
240563|NCT00406029|"~     The purpose of the study is to assess the efficacy and safety of a range of doses of SCH~     420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase~     inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2~     mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an~     Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on~     treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added.~      Approximately 160 participants will be randomized in this study in approximately 22 study~     centers worldwide for the first part of this study. Following the Interim Analysis, 40 new~     participants may be added, for a total of 200 participants. The study is double blind, which~     means neither you nor your study doctor will know whether you are receiving the study~     medication or placebo.~   "
240564|NCT00406016|"~     This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of~     6 dose regimens of ATI355 in acute spinal cord injury patients~   "
240565|NCT00406003|"~     The study was designed to describe the relationship between dose and pharmacokinetic~     parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR~     tablet (12.5 to 37.5 mg) as well as safety profile~   "
240566|NCT00405990|"~     The study aims to invite male sexual partners to attend antenatal clinic with their pregnant~     partners to either acquire pregnancy information or undergo voluntary counselling and testing~     for HIV. To see if male sexual partner involvement will decrease sexual risk behaviour.~   "
240567|NCT00405977|"~     The aim of this study is to investigate whether an optimized pre-treatment with intravenous~     magnesium enhances the speed of onset of a standard intubation dose of rocuronium.~   "
240568|NCT00405964|"~     This study will investigate the effectiveness of desloratadine in treating subjects with~     allergic rhinitis who meet the criteria for persistent allergic rhinitis (PER)~   "
240569|NCT00405951|"~     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow~     unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis~     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process~     of cell death that is often inhibited in cancer cells.~      This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination~     with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung~     Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial~     agents or therapies other than those described herein may be administered with the intent to~     treat the patient's malignancy. Supportive care measures including those directed at~     controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed.~   "
240570|NCT00405938|"~     This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with~     trastuzumab in the treatment of metastatic breast cancer in postmenopausal women. It is hoped~     that these combinations will keep the cancer from growing and spreading further.~   "
240571|NCT00405925|"~     Antiretroviral naïve patients with <350 xE6/l CD4 cells and a HIV-viral load of > 30.000~     cop/ml are started on combivir ® and Kaletra ®. When patients have reached an undetectable~     viral load of< 50 cop/ml on two consecutive occasions at least at week 12, but no later than~     week 24, they are randomised in either continuation with Combivir/Kaletra or switch to~     Trizivir ® twice daily one pill during 96 weeks. All patients randomised in the~     combivir/Kaletra arm are eligible to switch to Trizivir at any post randomisation visit when~     they reach predefined switch criteria for elevated levels of fasting glucose or lipids.~   "
240572|NCT00405912|"~     After a steady decline for the last 50 years, the prevalence of tobacco use in the United~     States has reached a plateau of approximately 23%. Currently available treatments among~     adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need~     to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult~     tobacco use prevalence.~      Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central~     synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant,~     St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating~     mild to moderate depression. SJW is well tolerated, available over the counter, and is~     significantly less expensive than the established treatments for tobacco dependence.~      To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of~     tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing~     tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind,~     placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants~     (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week~     course of SJW 900 mg per day, 1800 mg per day, or a matching placebo.~      This study is anticipated to provide the data needed to develop a larger randomized~     controlled clinical trial submitted through the R01 funding mechanism.~   "
240573|NCT00405899|"~     The objective of this study is to determine whether there is a relationship between~     interferon-gamma levels and the incidence of viral respiratory infections in allergic~     children treated with allergy immunotherapy as compared to those treated with standard~     medical care (nasal steroids, antihistamines) over a 1-year period. The hypotheses to be~     tested are 1) interferon-gamma levels will be significantly increased 3, 6, 9 and 12 months~     in allergic children treated with allergy immunotherapy as compared to those treated with~     standard medical care, 2) the incidence of viral respiratory infections will be reduced at 3,~     6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to~     those treated with standard medical care.~   "
240586|NCT00405730|"~     To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to~     Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment~     of ocular inflammation and ocular pain after cataract extraction with IOL implantation~   "
240574|NCT00405886|"~     Tinnitus is commonly referred to as ringing of the ears - the perception of sounds in the~     absence of an external source of acoustic signals. Tinnitus may represent a severe disease~     and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing~     loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate~     and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous~     system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh~     receptor blocking activity. The purpose of this study is to assess the safety and efficacy of~     Neramexane compared with placebo in patients with subjective tinnitus.~   "
240575|NCT00405873|"~     The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer~     patients with advanced primary hepatocellular carcinoma~      The primary endpoint is best overall response rate within 20 weeks after registration~   "
240576|NCT00405860|"~     Microscopic polyangiitis (MP) is a primary systemic vasculitis predominantly affecting small~     blood vessels. Following the widespread introduction of ANCA testing, the primary systemic~     vasculitis (SV), Wegener?s granulomatosis (WG) and microscopic polyangiitis (MP) appear to be~     more frequent than was previously thought (see definitions in Appendix 6). In addition, the~     existence of early and organ-limited forms of these diseases, such as renal-limited~     vasculitis (RLV) is now clearly recognized. Their annual incidence exceeds 20 per million per~     year and they account for at least 5 % of the causes of end stage renal failure. The two~     diseases share many features of their histology, serology and response to treatment, pointing~     to similarities in their pathogenesis, which have justified a common approach to their~     management. The standard treatment with corticosteroids (CS) and cyclophosphamide (CYC) is~     usually effective at controlling active disease but continued treatment is necessary to~     prevent disease relapse. Due to the cumulative toxicity associated with CYC treatment,~     alternatives have been looked for. Mycophenolate mofetil (MMF) has been used to treat~     patients with a variety of immune-mediated nephritides, including ANCA-associated vasculitis,~     with less toxicity than CYC but with variable outcome. The present trial will examine whether~     substitution of oral CYC with oral MMF is equally efficient for induction of remission with~     less adverse effects in cases of MP with mild to moderate renal involvement. All patients~     will receive the same regimen of oral prednisone + MMF. Prednisone will be tapered to a stop~     after 24 weeks but MMF will continue for a total of 18 months unless there is worsening or~     persistent disease. The trial ends after 18 months.~   "
240577|NCT00405847|"~     The purpose of this study is to assess the short-term effect of sympatholysis on sleep~     quality and inflammation in critically ill patients.~   "
240578|NCT00405834|"~     This study is to evaluate the clinical safety and effectiveness of the Envision® surface.~   "
240579|NCT00405821|"~     This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2~     (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and~     HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and~     may make HIV progress faster. The study will evaluate:~      Whether people who take acyclovir can avoid antiretroviral treatment until later in their~     lives~      Whether people who take acyclovir get fewer genital ulcers~      How well people are able to take acyclovir and any side effects they experience from it~      Differences in the amount of HIV virus in the blood of patients who are and are not taking~     acyclovir, and how HIV/AIDS is different in these patients.~      People 18 years of age and older living in the Rakai district of Uganda who are infected with~     both HIV (early stage disease) and HSV-2 may be eligible for this study. Participants are~     randomly assigned to take the study drug, acyclovir, or a placebo (look-alike pill with no~     active ingredient) daily for 2 years. During this time, they visit the clinic once a month~     for a routine physical examination. Patients who develop genital ulcers or complications of~     HIV are treated for the problem, and patients whose HIV disease progresses, requiring them to~     begin antiretroviral therapy, are treated accordingly.~   "
240580|NCT00405808|"~     Primary objective:~      To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting~     Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of~     12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with~     impaired fasting blood glucose and with or without associated comorbidities.~      Main Secondary objectives:~      To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist~     circumference (WC), body weight, glycemic parameters and lipid parameters.~      To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.~   "
240581|NCT00405795|"~     This observational study will acquire initial clinical practice utilization and product~     safety data for the Envision® surface.~   "
240582|NCT00405782|"~     This study is being done to evaluate the impact of moderate-intensity exercise (such as~     walking) on quality of life, energy level, endurance and mood in women with metastatic breast~     cancer. Studies have shown that women with early stage breast cancer who exercise during~     treatment have more energy, less sleep disturbance, less anxiety and depression, and better~     strength and endurance than women who do not exercise. These studies have also shown that~     women who exercised during treatment for early stage breast cancer did not develop injuries~     or increased fatigue from exercising during chemotherapy and radiation treatments. The~     investigators are conducting this trial to see if women with metastatic breast cancer~     experience similar benefits from exercise as women with earlier breast cancer. The~     investigators also wish to determine whether women with advanced disease are able to exercise~     safely during their treatment under the supervision of an exercise physiologist.~   "
240583|NCT00405769|"~     This study will attempt to further validate a clinical treatment plan to lower LDL values~     using non-prescription supplements combined with a lifestyle change and education program~     which could represent an alternative approach to improve compliance in group of people who~     are unable to take traditional medication to lower cholesterol.~   "
240584|NCT00405756|"~     The purpose of this study is to determine whether lenalidomide is safe and effective in the~     treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.~   "
240585|NCT00405743|"~     Patients with refractory or relapsed hematologic malignancies will receive CP-4055~     intravenously(IV) on Day 1-5 every three weeks until complete response or disease~     worsening/progressing~   "
240587|NCT00405717|"~     Clopidogrel and statins are frequently coadministered in patients with ischemic heart~     diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine~     diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain~     statins. The objective of the present study is to define which kind of statins might~     interfere with the antiaggregation property of clopidogrel in patients with acute coronary~     Syndrome after percutaneous coronary intervention (PCI).~      In this prospective randomized study, all patients in test group will receive clopidogrel~     plus atorvastatin, and all patients in control group will receive clopidogrel plus~     pravastatin. All patients will be followed up for one year. The primary endpoints include~     death, non fatal AMI, urgent revascularization. The secondary endpoints include hemorrhage~     events and subacute thrombosis events at 1 year.~   "
240588|NCT00405704|"~     In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with~     vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic~     urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ)~     prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal~     scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial~     resistance.~   "
240589|NCT00405691|"~     The purpose of this multi-center, randomized, clinical study is to establish the safety and~     effectiveness of the TOPS™ System, used following decompression, in the treatment of lower~     back and leg pain with, or without spinal claudication, that results from moderate or severe~     lumbar spinal stenosis at one vertebral level between L3 and L5.~   "
240590|NCT00405678|"~     To determine the effects of endurance exercise training on cardiopulmonary fitness in breast~     cancer patients undergoing neoadjuvant chemotherapy.~   "
240591|NCT00405665|"~     The objective of this trial is to determine the safety and effect on pulmonary function of 14~     days of inhaled L-arginine versus placebo administered over a period of 14 days in a cohort~     of CF patients.~   "
240592|NCT00405652|"~     Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in~     gastrointestinal (GI) complications in some patients. This study will assess if a switch from~     MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or~     health-related quality of life in liver transplant recipients~   "
240593|NCT00405639|"~     The following are done for screening procedures to determine if patients are eligible for~     this study: blood count, kidney and liver blood tests. Patients will complete a 6-minute walk~     test. Patients will be instructed to follow a no-added-salt diet for 1-3 weeks before the~     study and for the whole duration of the study. Diet instructions will be given to the patient~     and the patient will collect his/her urine for 24 hours before the active study day. Patients~     will need to avoid strenuous exercise and abstain from smoking, alcohol, and caffeine for 3~     days prior to the study days. Patients will remain on their regular medications.~   "
240594|NCT00405626|"~     To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis~     Perenis and Arnica montana~   "
240595|NCT00405613|"~     The purpose of this study is to determine if aspirin is associated with bleeding~     complications following a single tooth extraction~   "
240596|NCT00405600|"~     The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable~     spine joints. A patient may or may not receive rods and screws with the use of bone graft~     materials to facilitate bone growth and a fusion thus preventing movement of the bones of the~     spine.~      In this research study, bone graft substitute material called Bone Morphogenetic Protein-2~     known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will~     consist of BMP-2 Infuse with or without the use of rods and screws.~   "
240597|NCT00405587|"~     The primary objective of this FIH study is to assess the safety and pharmacokinetics of~     PLX4032 in patients with solid tumors. The secondary objective is to assess the~     pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant~     melanoma who have the V600E BRAF oncogenic mutation.~   "
240598|NCT00405574|"~     This is a multicenter, randomized, phase II study of the safety and efficacy of two dose~     levels of oral ATN-224 in patients with prostate cancer with a rising serum PSA in the~     absence of detectable disease. Patients will be randomized (1:1) after confirmation of~     eligibility requirements. The primary endpoint is to determine the proportion of patients who~     do not have PSA progression for 24 weeks. PSA progression is defined as at least a 50%~     increase in PSA and >5 ng/mL from baseline or post-treatment nadir if lower than baseline,~     confirmed by another PSA at least 28 days later.~   "
240599|NCT00405561|"~     The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients~     with advanced colorectal carcinoma.~      The primary endpoint is progression free survival rate at 18 weeks after registration~   "
240600|NCT00405548|"~     The purpose of this research study is to evaluate the effects of cardiac hormone replacement~     with SQ (subcutaneous or under the skin) injection of BNP (brain natriuretic peptide, a~     hormone produced by the heart) on the pumping ability of the heart, kidney function and~     levels of different hormones in the blood in response to an intravenous salt solution.~   "
240601|NCT00405535|"~     The purpose of this study is to determine whether individuals with obsessive compulsive~     disorder who will take a preparation of the amino acid glycine in addition to their current~     treatment, may experience improvement in their symptoms.~   "
240602|NCT00405522|"~     The objective of this study is to compare intraoperative and recovery parameters in patients~     who receive two different dose combinations of propofol and remifentanil in patients~     undergoing a lumbar puncture.~   "
240603|NCT00405509|"~     This study examines the cold processes of children aged 6 to less than 14. Children will be~     seen by the study staff 6 days in a row during the course of their naturally-acquired colds.~     Nasal secretions will be examined for chemicals that the body creates during a cold. Skin~     cells will be collected by brushing the inside of the child's cheek with a small brush. The~     cells will be examined for genes that may hold control the creation of these chemicals.~   "
240604|NCT00405496|"~     The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is~     effective in the treatment of uveitis.~   "
240605|NCT00405483|"~     The purpose of this study is to determine if MIS for primary hip replacement surgery~     increases the risk of long term aseptic loosening as predicted by implant micromotion~     detected by radiostereometric analysis.~   "
240607|NCT00405457|"~     To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial~     Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI)~     score and symptoms will be the same or lower than baseline after treatment in these patients.~     The patients will tolerate the combination of Restasis® and Optive® with a low incidence of~     clinical adverse events.~   "
240608|NCT00405444|"~     The purpose of this study is to determine whether intranasal fentanyl is better than placebo~     at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG~     study.~   "
240609|NCT00405431|"~     The purpose of this study is to determine whether reducing inflammation of the surface of the~     eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase~     patient comfort.~   "
240610|NCT00405418|"~     Primary objective:~      To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in~     term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment~     period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56~     mg/dL (3.1 mmol/L)~      Secondary objectives:~        -  To compare between the 2 treatment groups, the percentage of patients who reach the~          target of HbA1c < 7% and < 6.5% at the end of the treatment period~        -  To compare the changes in HbA1c and fasting plasma glucose (FPG)~        -  To compare the evolution of blood glucose profiles~        -  To compare the day to day FPG variability, the insulin doses~        -  To determine in each treatment group the biochemical and patient-related determinants of~          failure to reach HbA1c targets~        -  To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal~          symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L)~        -  To compare over the treatment period, the overall incidence and rate of symptomatic~          hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]),~          of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of~          severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL~        -  To compare the overall safety: incidence of adverse events (including serious~          hypoglycemia and local tolerance at injection site), change in body weight, in waist~          circumference and in waist / hip ratio~        -  To assess the quality of life and treatment satisfaction~   "
240611|NCT00405405|"~     To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when~     used with chemotherapy and radiation therapy in advanced head and neck cancer~   "
240612|NCT00405392|"~     This is a randomized open label, multi-centre study for Korean women with postmenopausal~     osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or~     the once-weekly dosing of risedronate.~      Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly~     regimen.~      Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with~     risedronate 35 mg or vice versa.~      After taking the first interventional medicine for 3 months or 12 weeks completely, a subject~     changes the treatment arm. There is no washout period.~   "
240613|NCT00405379|"~     Trabecular Metal(TM) is a relatively new technology and its use in knee replacement is quite~     different from the more conventional total knee replacement (arthroplastie). The aim of~     incorporating TMM into the material used for the knee replacement (tibial prostheses) is to~     improve initial fixation of the prosthesis at the time of implantation (surgery) and to~     improve long term prosthesis survival by encouraging and improving bone ingrowth.~   "
240614|NCT00405366|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed.~      PURPOSE: This clinical trial is studying the side effects and how well sorafenib works in~     treating patients undergoing surgery for stage II, stage III, or stage IV kidney cancer.~   "
240615|NCT00405353|"~     Since men are less likely to develop multiple sclerosis, the hypothesis was that testosterone~     might be protective in MS. Men with MS for followed untreated for 6 months, followed by a 12~     month treatment period with Androgel.~   "
240616|NCT00405340|"~     Membranous glomerulopathy (MN) is still the most common glomerular disease associated with~     nephrotic proteinuria (NS). Up to 40% of patients reach end stage renal failure (ESRD),~     making MN the 2nd or 3rd most common cause of ESRD caused by a primary glomerulopathy.~     Current treatment options include corticosteroids, alkylating agents, and cyclosporin, but~     their use is controversial and the associated adverse effects and high cost temper their~     usage. Experimental data in MN suggests that B cell activation results in immunoglobulin~     deposition along the glomerular basement membrane causing injury to the membrane and~     subsequent proteinuria. Drugs that non-selectively inhibit B cells and, these pathogenic~     antibodies, are closely associated with improved outcomes. Based on the rationale that~     selective depletion of B cells in humans would prevent the production of ?nephrotoxic?~     immunoglobulins and subsequent renal injury we recently treated 15 patients with MN with~     rituximab 1g i.v. twice (day 1 and day 15). Baseline proteinuria of 13.0±5.5g/24h decreased~     to 9.1±7g, 9.7±8g and 6.5±6 g/24h at 3, 6, and 9 months, respectively (mean ± SD). Analysis~     of the pharmacokinetic data obtained from this study, however, suggests that in heavily~     nephrotic patients, rituximab dosed in this fashion results in patients being under-treated.~     The present study propose to test the hypothesis that rituximab, given in accordance to the~     standard lymphoma protocol (375mg/m2 x 4), will result in a more effective and profound~     depletion of B cells, a more complete suppression of pathogenic antibodies, and a higher~     remission rate of the NS while maintaining a favorable safety profile.~   "
240617|NCT00405327|"~     Localized solid tumors such as, sarcoma, neuroblastoma, and Wilms' tumor, can generally be~     effectively treated with a combination of surgery, radiation and chemotherapy. However,~     patients with metastatic or relapsed disease have a very poor prognosis.~      New approaches to the management of these difficult groups of patients are needed. There is~     evidence to suggest that solid tumors may be good candidates for immunotherapy approaches. In~     fact, recent experimental evidence indicates that the period of lymphopenia that occurs after~     stem cell transplant may be an opportune time to use an immunotherapy treatment approach. In~     light of the very poor prognosis of young patients with advanced solid tumors, this treatment~     approach warrants further investigation.~   "
252828|NCT00242268|"~     The purpose of this study is to determine if using Avonex in combination with Zocor is a safe~     and effective therapy for subjects with relapsing remitting multiple sclerosis.~   "
240621|NCT00405275|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease of the joints leading to joint~     destruction, with significant long-term morbidity and mortality. Early treatment of RA~     patients with disease-modifying antirheumatic drugs (DMARDs) significantly decreases these~     complications. Methotrexate (MTX) is an excellent, economical first-line DMARD used to treat~     a majority of RA patients. While most patients respond well to MTX, many continue to have~     active disease. Therefore, understanding how to best treat RA patients with active disease~     despite MTX therapy is critically important. Although a number of therapies with~     significantly different economic implications have been shown to be effective when added to~     MTX, no trial has directly compared active therapies. This study will compare therapeutic~     strategies using two regimens with proven efficacy when added to MTX therapy; a)~     hydroxychloroquine and sulfasalazine (cost ~ $1000 per year); b) the tumor necrosis factor~     inhibitor, etanercept (cost ~ $12,000 per year).~      We propose a bi-national multi-center randomized, double-blind equivalency trial comparing~     (A) the strategy of initially adding hydroxychloroquine and sulfasalazine to MTX in patients~     with active disease despite MTX, with a switch at 24 weeks to etanercept in nonresponders to~     (B) a strategy of adding etanercept to MTX, with a switch to hydroxychloroquine and~     sulfasalazine in nonresponders at 24 weeks. If we find that the strategy of first adding~     hydroxychloroquine and sulfasalazine to MTX identifies a subset of responsive patients and~     that there is no harm to nonresponders because of early rescue with etanercept, then this~     less expensive option should become the standard treatment for MTX resistant patients.~      Four hundred and fifty RA patients with active disease despite treatment with MTX as~     indicated by a Disease Activity Score with 28 joints (DAS28) of >4.4 units will be~     randomized. A DAS improvement of <1.2 (validated as clinically significant) at 24 weeks will~     be used to identify early nonresponder who will switch therapy. Subjects with a DAS28~     improvement of > 1.2 at 24 weeks will remain on their initial therapy. The primary endpoint~     is the change of DAS 28 scores from baseline to 48 weeks. The secondary endpoint is~     comparison of radiographic progression of disease at 48 weeks, as measured by the change in~     Sharp score. Economic and functional outcomes will be assessed and a serum and DNA bank will~     be established to evaluate potential biomarkers predictive of treatment response/toxicity and~     disease progression. This trial will recruit 450 subjects over 40 months. At the end of the~     48 week blinded active therapy portion of the trial, the blind will be broken and data will~     be collected in an open fashion until all 450 patients have completed the 48 week portion of~     the trial.~   "
240622|NCT00405262|"~     The efficacy of three postoperative pain management regimens will be compared in patients~     undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to~     determine the best way of managing postoperative pain.~   "
240623|NCT00405249|"~     The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.~   "
240624|NCT00405236|"~     Patients with COPD experience exacerbations that are a major cause of morbidity.~     Exacerbations are associated with increased airway and systemic inflammation and those~     experiencing frequent exacerbations demonstrate increased inflammation in the stable state.~     Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that~     this is due to a reduction in inflammation. The study will compare airway inflammation and~     exacerbation frequency in patients with COPD on tiotropium or placebo.~   "
240625|NCT00405210|"~     The purpose of the trial is to determine the most effective dose of BAy 46-9003 associated to~     taxotere for first-line treatment of patient with prostatic cancer.~      BAY 43-9006 (SORAFENIB) is a novel dual-action Raf kinase and VEGFR inhibitor, which is~     orally available and has a favorable safety profile in patients with advanced solid tumors.~     This, together with the antitumor activity observed after treatment with BAY 43-9006~     (SORAFENIB), provides a rationale for further evaluation in patients with advanced cancer.~     The recommended dose of BAY 43-9006 (SORAFENIB) for future studies is 400 mg bid as a~     continuous dosing schedule.~   "
240626|NCT00405197|"~     Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands~     ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is~     expected to increasing. Prevention is therefore warranted. In this respect the amount and~     type of fat in the diet deserves attention. Recently, an intervention study reported that a~     diet high in mono-unsaturated fatty acids (MUFA) such as from olive oil, increased insulin~     sensitivity in healthy subjects. However, additional beneficial effects can be expected from~     the Mediterranean diet as a whole. Hypothesis: Replacing saturated fatty acids (SFA) by~     mono-unsaturated fatty acids (MUFA) will improve hyperinsulinemia and dyslipidemia, and a~     typical Mediterranean diet will even have more pronounced effects. Study objectives: To~     investigate the impact of the Mediterranean diet, and especially the intake of MUFA, on~     markers of the metabolic syndrome in high-risk subjects. Methods: The controlled dietary~     intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity. After~     a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets~     for a period of 8 weeks. Measurements of serum insulin concentration and other parameters~     will be carried out at weeks 2 and 10. Expected results: Our study will provide information~     on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean~     type of diet on the metabolic syndrome.~   "
240627|NCT00405184|"~     This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in~     patients with primary immune deficiency currently being treated with Intragam P. Eligible~     patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven~     cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly~     intervals. Patients will be monitored on the study for up to 36 weeks.~   "
240628|NCT00405171|"~     Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with~     human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz~     (EFV), are associated with increases in serum lipids. The investigators investigated whether~     stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein~     cholesterol, while keeping virologic control of HIV.~   "
240629|NCT00405158|"~     The objective of the study was to test the hypothesis that acupuncture treatment hastens~     recovery time from inflammatory symptoms of the breast during breastfeeding. 205 mothers with~     210 cases of breast inflammation (commonly called mastitis) during breastfeeding were~     randomly assigned to one of three treatment groups. There were two groups where acupuncture~     was used and one without acupuncture. The mothers symptoms were recorded at the onset of~     health care contact and daily until recovery. All care interventions given, including~     antibiotic therapy, were monitored. Women who participated were asked to leave a breast milk~     sample to test for bacterial growth. It was found that acupuncture did not shorten the~     women's contacts with health care services but did improve their symptoms on contact days 3~     and 4. It was seen in this study that only 15 % of women were prescribed antibiotics which~     was a very low rate of prescription compared to USA, Canada, Australia, Turkey and New~     Zealand where up to 100% are given antibiotics. Seven women (3.3% of those in the study)~     developed a breast boil and this is a similar number to a study in Australia where many more~     were treated by antibiotics. This could mean that many women throughout the world are given~     antibiotics when in fact they may recover without them. This is an important finding in~     relation to the fight against antibiotic resistant bacteria.~   "
252896|NCT00241371|"~     To determine the overall response rate (CR+PR) of patients with relapsed or refractory~     multiple myeloma treated with clofarabine.~   "
240630|NCT00405145|"~     This study aims improving the outcome after brain resective surgery of epileptic patients by~     improving presurgical evaluations. In particular the specific goal is to evaluate the ability~     of non invasive neuroimaging (functional magnetic resonance imaging and~     electroencephalography) to provide presurgical maps of the functional areas of the brain and~     of the epileptogenic networks.~   "
240631|NCT00405119|"~     Current treatment for gastroesophageal reflux disease (GERD) confirms an unmet need in~     patients, based on slow onset of action and an inability to provide 24-hour gastric-acid~     suppression. Clinical data on AH234844 demonstrates a rapid onset of action, high potency,~     and prolonged duration of effect. The present study endeavors, in part, to compare~     lavoltidine to two GERD drugs, NEXIUM and ranitidine.~   "
240632|NCT00405106|"~     To evaluate the effects of exam preparation on anxiety level, self perception, ocular~     symptoms and oculomotor responses in myopes~   "
240633|NCT00405093|"~     Primary Objective: The aim of this study is to assess the effects of Aprotinin (an~     antifibrinolytic drug used to reduce bleeding during cardiac surgery) on renal function in~     patients undergoing surgery with use of hypothermic bypass and circulatory arrest for repair~     of the thoracic aorta.~      Secondary Objective: To compare the effects of Aprotinin and Amicar on major vascular~     outcomes following thoracic aorta surgery with use of hypothermic bypass and circulatory~     arrest.~   "
240634|NCT00405080|"~     This study will examine what the body does while taking GW679769 alone and together with~     rifampin in healthy adult subjects.~   "
240635|NCT00405067|"~     The main objectives of this study are to evaluate the efficacy and safety of combination~     therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol~     and other lipoproteins over 12 weeks of therapy.~   "
240636|NCT00405054|"~     This study will evaluate MK0457 in patients with chronic myelogenous leukemia and~     Philadelphia chromosome-positive acute lymphoblastic leukemia. Efficacy and safety will be~     evaluated.~   "
240637|NCT00405041|"~     The objective of the study is to evaluate the efficacy of a neuroprotective dietary~     supplement in patients suffering from herniated lumbar disc causing nerve root compression.~   "
240638|NCT00405015|"~     Cardiovascular disease is the leading cause of death in diabetic patients due to both a high~     event rate and a worse outcome. A pharmacological intervention that reduces~     ischemia-reperfusion-injury would improve the outcome of diabetic patients after a~     cardiovascular event. In the present study, we will use annexinA5 scintigraphy to address the~     following hypothesis:~      Rosiglitazone reduces ischemia-reperfusion-injury in humans with insulin resistance.~   "
240639|NCT00405002|"~     In this study the investigators aim to evaluate a new system dedicated to estimate the end~     expiratory lung volume, by measuring the VO2-VCO2, during mechanical ventilation compared to~     the helium dilution technique and the computed tomography (CT) scan.~   "
240640|NCT00404989|"~     The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major~     teratogenic effect involving any of the Registry drugs when administered to pregnant women.~     Registration is voluntary and confidential with information obtained from the health care~     provider. A Registry-assigned identifier allows for follow-up capability. Information on~     subjects is provided to the Registry prospectively (prior to the outcome of pregnancy being~     known) through their health care provider, with follow-up obtained from the health care~     provider after the outcome is determined. Providers are strongly urged to enroll their~     patients as early in pregnancy as possible to maximize the validity of the data. In addition,~     the Registry is very interested in assembling a group of providers who are willing to make a~     commitment to report all of their site's antiretroviral pregnancy exposures to the Registry,~     thereby assuring all cases can be considered prospective. Providers are encouraged to contact~     the Registry for more information about this group. The Registry is informed in its analysis~     by other data, for example, retrospective reports and clinical studies.~      Given the increasing number of medications and more aggressive approach to therapy, more HIV-~     and hepatitis B-infected women may be treated during pregnancy or become pregnant while under~     treatment. The paucity of data on use and infant outcomes of antiretroviral therapies during~     pregnancy makes this Registry an essential component of the ongoing program of epidemiologic~     studies of the safety of these therapies.~      Each year the Registry has enrolled approximately 1300 pregnant women in the US exposed to~     antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive~     women who give birth to live infants annually in the US.~   "
240641|NCT00404976|"~     Background:~      Exhaled nitric oxide and inflammatory biomarkers in exhaled breath condensate may be useful~     to diagnose and monitor childhood asthma. Their ability to indicate an asthma diagnosis, and~     to assess asthma severity and control, is largely unknown.~      Objective:~      To study 1) the ability of exhaled nitric oxide and inflammatory markers in exhaled breath~     condensate (nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis~     factor-α, interleukin-2,-4,-5,-10, acidity) to discriminate between childhood asthma and~     controls. 2) the ability of these biomarkers to indicate asthma severity and control.~      Methods:~      114 Children were included: 64 asthmatics (10.7±3.0 years, 67.2% atopic) and 50 controls~     (10.0±0.4 years). Condensate was collected using a glass condenser~   "
240642|NCT00404963|"~     This study represents the first administration of GSK376501 in humans and the goal is to~     evaluate its initial safety and tolerability. The way the human body processes GSK376501 will~     also be determined.~   "
240643|NCT00404950|"~     To determine whether intraoperative hyperglycemia potentiates renal injury in the setting of~     cardiac surgery requiring cardiopulmonary bypass.~   "
240644|NCT00404937|"~     The purpose of this study is to compare the new formulation of Tobradex to the current~     approved formulation~   "
240645|NCT00404924|"~     This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is~     more effective than best supportive care alone, for the treatment of patients with non-small~     cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal~     Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug~     in development that works in a different way to standard chemotherapy drugs. It targets the~     growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour~     may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour~     may take to progress to a further stage. Approximately 930 patients will take part in this~     study. It will be conducted in hospitals and clinics in North and South America, Europe and~     Asia.~   "
240646|NCT00404911|"~     This study will examine the effectiveness of a multiple family group mental health service~     delivery strategy in improving mental health service use and outcome for urban, low income~     children of color, ages 7-11 years old with disruptive behaviors and their families.~   "
240647|NCT00404898|"~     The American Red Cross has funded a multidisciplinary, comprehensive evaluation and treatment~     program for target individuals with suspected World Trade Center (WTC)-related health~     problems. The populations served consist predominantly of a) local residents who were~     impacted by the disperion of the WTC dusts and fumes, b) individuals involved in cleaning and~     debris removal of local commercial spaces, and c) responders to the WTC collapse. These~     populations are recruited from past and ongoing programs that we have developed as well as~     from ongoing collaborations with community organizations that include: the Beyond Ground Zero~     Network, 9/11 Environmental Action committee, and the WTC Residents Coalition. In addition,~     there is collaboration with the Charles B. Wang Community Health Center and the centers~     involved in the ongoing WTC Workers and Volunteer Medical Screening and Monitoring Program.~     We would now like to access the data from this treatment program to create a NYU/Bellevue WTC~     Health Impacts Research Registry to increase knowledge about the health effects of exposure~     to World Trade Center dust.~   "
240648|NCT00404885|"~     The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in~     subjects with active non-infectious anterior uveitis~   "
240649|NCT00404872|"~     Cardiovascular disease (CVD) affects millions of people in the United States; each year, more~     people die from CVD than from any other disease. Individuals with low levels of n-3 fatty~     acids and high levels of trans-fatty acids may have an increased risk of developing CVD. This~     study will evaluate the link between fatty acids and the presence of CVD in older adults.~   "
240650|NCT00404859|"~     Background By means of measurements of series of non-invasive inflammatory markers in exhaled~     breath (condensate), a reflection of inflammatory processes and oxidative stress, can be~     obtained. Thereby, these techniques could be important in monitoring asthma and CF lung~     disease in children. Fractional exhaled nitric oxide (FeNO) and inflammatory markers in~     exhaled breath condensate (EBC) reflect ongoing inflammation and oxidative stress in the~     airways. These markers have a promising capacity for monitoring diagnoses of CF and asthma~     lung disease.~      Aim To study the course of inflammatory markers in time in children with asthma and CF, in~     stable periods and during pulmonary exacerbations. In addition, we study the ability of~     inflammatory markers to predict safe tapering of medical treatment in both populations.~        1. To study the course of inflammatory markers in EBC during an exacerbation.~        2. To study which IM are already elevated before a clinical exacerbation is evident and can~          predict exacerbations in time.~        3. To study which inflammatory markers can predict safe discontinuation of antibiotics in~          children with CF, or tapering of inhaled corticosteroids in children with asthma.~        4. To study the relationship between inflammatory markers in EBC, the severity and control~          of CF and asthma, the symptoms and lung function within patients will be analysed.~      Methods Children with CF (n=30) and children with asthma (n=40) were recruited included from~     our outpatient clinic. During this longitudinal study patients visit the outpatient clinic~     were followed–up for 12 months; every two months during one year. patients visited our~     outpatient clinic. In addition to these standard visits, During exacerbations patients four~     extra visits were planned during an exacerbation. were asked to visit the University Hospital~     Maastricht four times. These additional visits were planned with a maximum of two times~     during the study. By means of a home monitor, children were asked to assess measurements of~     Besides measurements in the University Hospital, children measured forced expiratory volume~     in one second (FEV1) at home using a home monitor, to record medication use, and, to record~     presence and severity of pulmonary symptoms. Outcome parameters were: 1) FeNO assessment in~     exhaled air, 2) inflammatory markers in EBC, 3) lung function parameters, 4) specific~     questionnaires to assess asthma and CF control and severity, 5) data originating from the~     home monitor.~   "
240651|NCT00404846|"~     The purpose of this investigation is to evaluate the cognitive and behavioral effects of~     Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism and other~     developmental disabilities.~   "
240652|NCT00404833|"~     This is a prospective randomized open-label pilot study to investigate the effect of~     mycophenolate mofetil treatment in patients with abnormal urine protein excretion due to~     membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS). The change in urine~     protein excretion will be the primary outcome studied. The treatment regimen comprising~     prednisolone and mycophenolate mofetil will be compared with prednisolone and chlorambucil in~     MN, and compared with prednisolone in FSGS. The study duration will be 12 months for each~     patient.~   "
240653|NCT00404820|"~     The aim of this study was to examine the effect of zoledronic acid and alendronate on bone~     metabolism as measured by biomarkers in postmenopausal women with osteoporosis.~   "
240654|NCT00404807|"~     The role of continuous positive airway pressure (CPAP) in cardiac function in patients with~     CSA and OSA has been studied with varying results. Nevertheless, it is not clear whether CPAP~     treatment for respiratory sleep disorders in CHF could slow down deterioration or improve the~     cardiovascular function.~      In an attempt to yield further insight into this subject, we undertook a multicentre study to~     analyze the role of CPAP therapy (optimal vs sham) in the LVEF and in other cardiac~     measurements in patients with CHF.Aim. We evaluated in a randomized multicentre placebo~     (sham-CPAP) controlled study the effect of CPAP treatment on the left ventricle ejection~     fraction (LVEF) among other cardiological related variables.~   "
240655|NCT00404794|"~     This is a prospective randomized open-label pilot study to compare mycophenolate mofetil in~     combination with corticosteroid treatment and tacrolimus in combination with corticosteroid~     treatment in membranous lupus nephritis. The change in urine protein excretion will be the~     primary outcome studied. The study duration will be 24 months for each patient.~   "
240656|NCT00404781|"~     Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary~     intervention has been proven. However, patients with low response to those agents are~     reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet~     therapy for individual patients based on platelet function assay may improve long-term~     outcomes especially in patients with high risk of thrombosis. In this prospective randomized~     study, patients in control group all receive standard dual antiplatelet therapy, and patients~     in optimized group receive different antiplatelet therapy according to risk stratification.~   "
240657|NCT00404768|"~     Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity~     and mortality and is frequently associated with long-term disability. Oxytocin is a hormone~     produced by the body during labor. GSK221149A is an experimental drug that will be used to~     block the effects of oxytocin, and therefore pause or prevent contractions. In this study,~     patients with preterm labor will be given an intravenous infusion of GSK221149A over~     approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study,~     patients with preterm labor will be give an intravenous infusion of GSK221149A over~     approximately 48 hours. The use of a rescue tocolytic is allowed in the study.~   "
240803|NCT00402857|"~     This study will evaluate the effectiveness of a parent training program in improving~     parenting skills and reducing behavioral symptoms in young children who are at risk for~     developing childhood behavior disorders.~   "
240658|NCT00404755|"~     This study will recruit 100 depressed patients to test whether the previous finding of an~     association between treatment response (with treatment groups including placebo, imipramine,~     and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also~     found with a different type of commonly used anti-depressant, bupropion.~   "
240659|NCT00404742|"~     The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in~     subjects with clinically quiescent non-infectious uveitis~   "
240660|NCT00404729|"~     In the management of glaucoma, as for as in other optic nerve diseases, an important goal of~     ophthalmologists is represented by the possibility of influencing visual function.~      In this regard, Parisi et al [Ophthalmology 1999; 106:1126-1134.] suggested the intramuscular~     treatment with Cytidine-5-diphosphocholine (CDP-Choline or citicoline) to improve~     glaucomatous visual defects. In particular, recent studies reported the effects of citicoline~     on glaucomatous retinal and postretinal visual structures evaluated by electrophysiological~     examinations (PERG and VEP). It was observed that a 2-month period of treatment with~     citicoline may induce improvement in both ganglion cell function (PERGs with increase in~     amplitudes and shortening in times-to-peak) and in neural conduction along postretinal visual~     pathways (VEPs with increase in amplitudes and shortening in times-to-peak). The effects of~     citicoline on glaucomatous retinal and postretinal structures were not present 8 months after~     the end of treatment. However, performing several 2-month period of treatment with citicoline~     during a total period of 8 years, it was found a additional improvement of the glaucomatous~     retinal and postretinal impairment [Parisi V. Doc Ophthalmol. 2005 Jan;110:91-102). In this~     work, we aimed to assess whether there similar visual function outcomes can be reached by the~     oral treatment with citicoline in patients affected by glaucomatous optic nerve disease as of~     as in other optic nerve diseases (i.e. non-arteritic ischemic optic neuropathy)~   "
240661|NCT00404716|"~     Cilostazol is an kind of oral antiplatelet agent with a rapid onset of action that~     selectively inhibits phosphodiesterase III, a mechanism different from adenosine diphosphate~     (ADP) receptor antagonists. Previous studies had suggested that cilostazol has~     lipid-modifying and vasodilating effects in addition to antiplatelet effects. From those~     experimental and clinical backgrounds, we assumed that triple antiplatelet therapy with~     aspirin, clopidogrel, and cilostazol might have a beneficial effect on the prevention of~     atherothrombosis complications following coronary stenting. Therefore, we evaluated the~     safety and efficacy of triple antiplatelet regimen of aspirin, clopidogrel and cilostazol~     compared with dual antiplatelet regimen of aspirin and clopidogrel in patients with acute~     coronary syndrome undergoing successful coronary artery stenting.~      Patients undergoing successful coronary stenting were divided into dual antiplatelet therapy~     (aspirin plus clopidogrel) and triple antiplatelet therapy (aspirin and clopidogrel plus~     cilostazol) groups. All enrolled patients in triple regimen group will receive cilostazol~     100mg, b.i.d., for 6 months in addition to standard dose and duration of aspirin and~     clopidogrel for post-PCI. The primary endpoints included death, myocardial infarction, target~     lesion revascularization, stent thrombosis within 30 days, binary restenosis at six month and~     major adverse cardiac events (MACE) at one year. The secondary endpoints were side effects of~     study drugs, including major bleeding, vascular complication, hypersensitivebility, and~     bleeding complications. The study will be powered to test the hypothesis that triple~     antiplatelet therapy is better than dual antiplatelet therapy.~   "
240662|NCT00404703|"~     This single arm study will assess the feasibility of using Avastin plus platinum-based~     chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or~     recurrent squamous non-small cell lung cancer who have not received prior chemotherapy.~     Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5~     cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly~     cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12~     months. The anticipated time on study treatment is 3-12 months, and the target sample size is~     <100 individuals.~   "
240663|NCT00404690|"~     The hypothesis is that there is no difference between bedside silo placement and operative~     closure in return of bowel function, ventilator dependence, or length of stay.~      The primary outcome variable between the two techniques will be determined from this study~     that can then be used to develop a definitive study. The likely variables will be length of~     time to meet discharge criteria, length of hospitalization, time to full feedings, time on~     mechanical ventilation and total hospital charges.~   "
240664|NCT00404677|"~     The loss of deep inhalation bronchoprotection in asthmatic individuals has been shown to be~     related to the degree of airway hyperresponsiveness, a hallmark of asthma. In several~     studies, asthmatic individuals with mild airway hyperresponsiveness (AHR) (methacholine PC20~     > 2 mg/mL) had a difference in methacholine PC20 with and without deep inhalations that~     averaged 1.8 doubling methacholine concentrations (p=0.0003). Conversely, asthmatic~     individuals with moderate to severe AHR (methacholine PC20 ≤ 2 mg/mL) had a non-significant~     difference in methacholine PC20 with and without deep inhalations (p=0.09). This loss of deep~     inhalation bronchoprotection is also now believed to play an important role in the~     pathogenesis of asthma. Airway inflammation is another of the key features of asthma and~     information on airway inflammation is increasingly being used in the diagnosis and treatment~     of asthma. The level of airway inflammation (as measured by fraction of exhaled nitric oxide~     and sputum eosinophilia) has also been shown to be correlated to the level of airway~     hyperresponsiveness (as measured by methacholine PC20). In addition, glucocorticoids have~     been shown to decrease airway hyperresponsiveness, further suggesting that these two~     phenomena, airway inflammation and airway hyperresponsiveness, are related. We therefore~     suggest that the degree of airway inflammation is related to the loss of deep inhalation~     bronchoprotection and expect there to be a negative correlation between the degree of deep~     inhalation bronchoprotection and airway inflammation.~   "
240665|NCT00404664|"~     The purpose of this study was to see if reminder letters and a large raffle prize would~     encourage health care workers to receive influenza vaccinations.~   "
240680|NCT00404469|"~     We will investigate the effect of peritendinous corticosteroid injections, eccentric training~     and heavy resistance training in male patellar tendinopathy patients. The purpose is to~     compare the clinical effect of these three treatments in a randomised controlled trial. Also~     we wish to investigate the treatment mechanisms responsible for the effectiveness of the~     three treatments.~   "
240666|NCT00404651|"~     The purpose of this trial is to clinically confirm that the manufacturing process of the~     final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.~      The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T~     vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after~     the three-dose primary series.~      The secondary objectives are:~        -  To describe in each group, the immunogenicity parameters for all antigens one month~          after the third dose of the primary series~        -  To assess the overall safety in each group one month after the third dose of the primary~          series.~   "
240667|NCT00404638|"~     Several treatment modalities for children suffering from monosymptomathic nocturnal enuresis~     are available including drugs, alarms, acupuncture, pelvic floor training and biofeedback.~     The aim of this study is to to test if Paula Method (circular muscle exercise) can be an~     another treatment modality.~   "
240668|NCT00404625|"~     To assess the molecular epidemiology, clinical impact, treatment outcome and risk factors for~     infections caused by Enterobacteriaceae producing ESBLs in Italy in a large multicenter~     observational survey.~      SPECIFIC OBJECTIVES~        1. To collect consecutive nonreplicate isolates of Enterobacteriaceae resistant to~          expanded-spectrum cephalosporins from clinical specimens from inpatients and~          outpatients.~        2. To characterize the isolates for resistance phenotypes and for β-lactam resistance~          mechanisms.~        3. To investigate the clonality of isolates.~        4. To analyse the epidemiology of various resistance mechanisms/resistant clones.~        5. To collect clinical and epidemiological data for patients with infections caused by the~          ESBL producers.~        6. To analyse the epidemiology, risk factors and outcome for infections caused by ESBL~          producers.~   "
240669|NCT00404612|"~     The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in~     subjects with active non-infectious uveitis~   "
240670|NCT00404599|"~     Background: HMG-CoA reductase inhibitors (statins) are effective lipid-lowering agents and~     are known to reduce cardiovascular events. Beneficial effects of statins seem to occur very~     early in the course of their therapy and subgroup analysis of large trials indicates that~     subjects in statin-treated arms have less cardiovascular events than subjects in~     placebo-controlled arm with comparable serum cholesterol levels. Therefore, it has been~     suggested that statins may have antiatherogenic effects beyond their cholesterol lowering~     effect. Many studies have demonstrated a rapid improvement in vascular function with~     atorvastatine which cannot solely be accounted for by achieved lipid reduction. A rapid~     oxidative stress lowering effect of atorvastatin has been proposed as the probable mechanism~     of this action. Whether atorvastatine has stronger antioxidant effect and whether~     atorvastatin lowers oxidative stress earlier in the course of therapy than other statins has~     not been studied yet.~      Objective: To compare the rapidity of onset and the extent of oxidative stress lowering of~     atorvastatin with that of an (in terms of LDL lowering) equipotent dosage of simvastatin.~      Methods: We plan to recruit sixty statin naive patients, with diabetes mellitus type 2 and/or~     obesity (BMI > 25) and/or hypertension (RR>140/90 mmHg). Patients with K/DOQI stage 5 chronic~     kidney disease (Cockcroft-Gault clearance of less than 15 ml/min/1.73m2), patients who use~     any vitamin preparation, or statins in the last three months and patients with LDL~     cholestrerol < 2.5 mmol/l will be excluded from the study. Because of the influence of~     angiotensin-converting enzyme inhibitors (ACE-inhibitors) on oxidative stress, patients will~     be stratified for prior ACE-inhibitor use during randomization. All included patients are~     randomized to treatment with simvastatin 40 mg daily or atorvastatin 10 mg daily to achieve a~     comparable lipid reduction. Established parameters of oxidative stress such as oxidized LDL,~     malondealdehyde and isoprostane will be measured in plasma on inclusion, one week, six weeks~     and three months after inclusion. We also plan to measure endothelial function parameters~     such as soluble Vascular Adhesion Molecule (sVCAM) and von Willebrand factor. In addition,~     parameters of inflammation such as high sensitive C - reactive protein, TNF-alfa,~     interleukin-6 and myeloperoxidase will be measured to investigate whether there is any~     correlation between oxidative stress lowering and endothelial function and inflammation. The~     inhibitory effect of HDL to prevent oxidation of LDL will be determined by measurement of~     lipid peroxides formed during in vitro oxidation of LDL co-incubated with HDL. The~     inflammatory / anti-inflammatory properties of HDL will be tested by measurement of the HDL~     capacity to inactivate oxidized palmitoyl-2-arachidonoyl-sn-glycero-3-phosphorylcholine~     (ox-PAPC). Collections of 24 hours of urine at the beginning and after one week, six weeks~     and three months will be used to measure urine F2-isoprostane levels.~      Analyses: All parameters of oxidative stress before and during treatment with both statins~     will be compared to determine whether atorvastatin causes a stronger and quicker reduction of~     oxidative stress than simvastatin. Generalized estimating equations (GEE) will be used to~     compare these effects. We plan to include a minimum of 30 patients in each treatment-group~     from the outpatient clinic of the department of internal medicine of the VU University~     Medical Center in Amsterdam.~      Expected results: Atorvastatin will reduce oxidative parameters stronger and earlier than~     simvastatin.~   "
240671|NCT00404586|"~     This study was designed to look at safety aspects and effects of intranasal doses of~     GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer~     with allergic rhinitis~   "
240672|NCT00404573|"~     This is a study designed to evalute the safety and efficacy of RGH-188 in the treatment of~     acute schizophrenia. This study will be 10 weeks in duration; 6 weeks double-blind treatment,~     and 4 weeks safety follow-up. All patients meeting the eligibility criteria will be~     randomized to one of the three treatment groups--one of two doses of RGH-188 or placebo~   "
240673|NCT00404560|"~     This screening study will examine the causes of immune disorders affecting white blood cells,~     which defend against infections and will try to develop better means of diagnosis and~     treatment of these immune disorders. This is a 2 visit screening study and patients~     determined to be of interest for additional study or treatment will be asked to provide~     consent for enrollment into an appropriate NIH follow up study. This study does not cover the~     cost of the first visit to NIH for travel or lodgings but does cover the subsequent visit if~     there is one. A financial assessment may determine if the patient is eligible for financial~     assistance. This study does not enroll children under the age of 2.~      Patients known to have or suspected of having increased susceptibility to infections and~     their blood relatives may be eligible for this study, at the discretion of the principal~     investigator. Patients and family members may undergo the following procedures:~        -  Personal and family medical history.~        -  Physical examination and blood and urine tests.~        -  Studies of breathing function (pulmonary function testing)~        -  Dental examination.~        -  Eye examination.~        -  Genetic Testing~        -  Stored specimens for future analysis~        -  Microscopic examination of saliva, wound drainage or tissues removed for medical reasons~          for cell, hormone or DNA studies.~      In addition, patients will be asked to obtain permission for investigators to obtain their~     medical records, previous test results, or radiographic studies prior to the first visit.~     Patients will be asked to undergo imaging studies, such as a chest X-ray, CT scan or MRI~     scan.~   "
240674|NCT00404547|"~     The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide)~     compared with usual asthma care in the primary care setting. Patients with a history of~     asthma for at least 6 months and who, in the opinion of the physician, meet the clinical~     requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either~     receive Alvesco® or usual care.~   "
240675|NCT00404534|"~     A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients~     without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic~     symptoms after Helicobacter eradication than the placebo control group~   "
240676|NCT00404521|"~     Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study.~     The purpose is to determine the safety, tolerability and to identify the dose limiting~     toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks,~     intravenously, over 30 minutes to subjects with advanced malignant solid tumors.~   "
240677|NCT00404508|"~     Chemotherapy resistance, either innate or acquired requires for its development, expression~     changes on a large number of genes therefore, it has been hypothesized that~     epigenetic-mediated changes could be the responsible driving force for chemotherapy~     resistance. Aberrant DNA methylation and histone deacetylation are the main epigenetic~     alterations hence, their reversal by inhibitors of DNA methylation and histone deacetylases~     (HDACs) may overcome resistance in refractory solid tumors.~      Patients will be treated with hydralazine and magnesium valproate starting from day -7 until~     chemotherapy ends which consists on the same pre-study protocol regimen on which patients~     progressed. Response and toxicity were evaluated. Global DNA methylation and HDAC activity~     were evaluated in the peripheral blood cells, as well as the plasma levels of valproic acid~     and hydralazine.~   "
240678|NCT00404495|"~     This study will assess the rate of objective confirmed tumor response of irinotecan in~     combination with temozolomide in children with recurrent or refractory medulloblastoma and in~     children with newly diagnosed high-grade glioma.~   "
240679|NCT00404482|"~     Juvenile idiopathic arthritis (JIA) is often associated with chronic anterior uveitis.~     Presence of vision threatening complications may indicate immunosuppressive therapy. In this~     study, the experience with cyclosporine A (CsA) as mono- or combination-therapy is analyzed.~   "
253011|NCT00239811|"~     This study will evaluate the long term safety and efficacy of FTY720 combined with~     cyclosporine and corticosteroids in patients receiving a kidney organ transplant~   "
240681|NCT00404456|"~     Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis~     patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For~     a good regulation of these circadian rhythms a uniform external synchronisation is necessary.~     This is the synchronisation of the biological clock of our body by light and other~     influences. In case of a disturbance of the external synchronisation, due to for example naps~     during the day or wake periods at night, internal rhythms can be unlinked. As a result a~     weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis~     patients have sleep problems. Their sleep latency is prolonged. They often take a nap during~     the day and their sleep efficiency is poor. There has only been one study on the melatonin~     rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of~     dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this~     study no link was made between melatonin rhythm and the nature and severity of possible sleep~     problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm,~     exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal~     biological clock and a better quality of life.~      The aim is to research the endogenous melatonin rhythm and to improve sleep problems of~     hemodialysis patients with a placebo-controlled study with exogenous melatonin. Next to this~     a substudy is performed, in which the effect of the change of daytime to nocturnal in~     hospital hemodialysis on sleep and melatonin is researched.~   "
240682|NCT00404443|"~     To study the efficacy of acupuncture used as an adjunct measure for patients with refractory~     RA~   "
240683|NCT00404430|"~     The main objective of the study is to evaluate the predictive factors of the endothelial~     function to the waning of an acute exacerbation in COPD. It will act to do a multivariate~     analysis to determine the respective weight of the parameters of the systemic inflammation,~     of the oxidative stress of the functional respiratory parameters and then functional~     respiratory parameters.~      In exacerbated Chronic Obstructive Pulmonary Disease (COPD) patients, there is augmentation~     of hypoxia and the obstructive ventilatory disorders is more important. This is correlated~     with an increase in C-reactive Protein (CRP) and of inflammatory cytokines and oxidative~     stress. It has been demonstrated that there is an endothelial dysfunction in answer to~     hypoxia. Since the exacerbated COPD patients are hypoxic in most cases , we suppose they have~     an endothelial dysfunction during exacerbation. So we think we will find an augmentation of~     vascular resistances ,shown by a peripheral arterial tone too high. And this, certainly, play~     a part in physiopathology of the COPD exacerbation.~   "
240684|NCT00404417|"~     This study will assess the efficacy and the duration of efficacy of Botulinum toxin A~     (Botox®) injected into the lumbar paraspinal muscles for reducing pain and disability in~     subjects suffering from chronic low back pain of six months duration or longer and arising~     from an identifiable muscle strain injury or back trauma. The treatment modality and~     techniques used are based on a successful prior 4 month open-labeled pilot study done by this~     research group, but will employ a prospective double-blind, randomized, cross-over design to~     control for any placebo or mechanical trigger-point injection effects. Subjects will also be~     assessed for a longer duration to better define the duration of efficacy.~   "
240685|NCT00404404|"~     RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     find tumor cells and kill them or carry tumor-killing substances to them. Others interfere~     with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of~     tumor cells by blocking blood flow to the tumor. Giving ABI-007 together with bevacizumab may~     kill more tumor cells.~      PURPOSE: This phase II is studying how well giving ABI-007 together with bevacizumab works in~     treating women with recurrent or metastatic breast cancer.~   "
240686|NCT00404391|"~     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety~     of the administration of 2 different dose levels of Extended Release~     Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had~     bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are~     discharged from the hospital.~   "
240687|NCT00404378|"~     This is a two period study of healthy adult subjects to characterize the effect of the dosing~     of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the~     safety profile of oral casopitant with and without ketoconazole. This study will consist of a~     screening period, two treatment periods and a post-treatment follow-up visit.~   "
240688|NCT00404365|"~     RATIONALE: Screening tests may help doctors find depression in patients with lung cancer,~     allow doctors to recommend treatment for depression, and improve the patient's quality of~     life.~      PURPOSE: This randomized clinical trial is studying how well depression screening works when~     the results are or are not shared with patients with lung cancer and their doctor.~   "
240689|NCT00404352|"~     The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical~     trial with an optional 12 months open label extension.~      The primary objective of the study is to evaluate the effect of fetal bovine serum~     [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN] beta-1a (RNF) 44~     microgram (three times weekly and once weekly) versus placebo on the time to conversion to~     McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical~     demyelinating event at high risk of converting to MS.~      The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three~     times weekly and once weekly) versus placebo on the Time to conversion to clinically~     definite MS (CDMS) in subjects with a first clinical demyelinating event at high risk of~     converting to MS.~      At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS~     and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month~     extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the~     time to conversion to McDonald MS and time to conversion to CDMS.~   "
240690|NCT00404339|"~     RATIONALE: Vaccines made from a person's dendritic cells mixed with peptides may help the~     body build an effective immune response to kill tumor cells.~      PURPOSE: This randomized phase I trial is studying the side effects of vaccine therapy in~     treating patients with head and neck cancer.~   "
243000|NCT00373724|"~     In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch~     radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a~     randomized, controlled study.~   "
240691|NCT00404326|"~     The current standard for locally advanced cervical cancer is concurrent cisplatin-based~     chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations play~     an important role in cancer progression by silencing growth regulatory genes and there is now~     evidence that inhibitors of DNA methylation and HDAC inhibition synergize the radiation and~     chemotherapy effects.~      Objective. To determine response rate, safety and biological effects of hydralazine and~     magnesium valproate when added to cisplatin chemoradiation.~      Hypothesis. Hydralazine and magnesium valproate associated to chemoradiation will increase~     the clinical complete response rate to 95% as compared to 75% as seen in historical controls~     treated with cisplatin chemoradiation in FIGO stage IIIB patients.~      Metodology. A total of 17 FIGO stage IIIB patients with histologically confirmed cervical~     carcinoma with no previous treatment will be included. Patients will be typed for acetylator~     status and and then receive either 182 or 83 mg of hydralazine, and magnesium valproate at~     40mg/Kg from day -7 to the end of chemoradiation (external and brachytherapy). Clinical~     response rate, safety and transcriptome changes will be analyzed.~   "
240692|NCT00404313|"~     A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic~     asthma.~   "
240693|NCT00404300|"~     An open, multi-centre study in patients with von Willebrand Disease (VWD) undergoing surgery.~   "
240694|NCT00404287|"~     Atherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in~     common. We hypothesized that statins therapy would decrease inflammatory markers~     concentrations in patients with degenerative aortic stenosis and halt the haemodynamic~     progression of the disease.~   "
240695|NCT00404274|"~     GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test~     the extent of the GW679769 affect on Warfarin levels in humans.~   "
240696|NCT00404261|"~     The purpose of this study is to evaluate the level of satisfaction experienced by asthma or~     chronic obstructive pulmonary disease (COPD) patients when using the Fluticasone/Salmeterol~     HFA Metered Dose Inhaler (MDI) with counter, as compared to using Fluticasone/Salmeterol HFA~     MDI without counter.~   "
240697|NCT00404248|"~     RATIONALE: Drugs used in chemotherapy, such as tetra-O-methyl nordihydroguaiaretic acid~     (EM-1421), work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of EM-1421 and to~     see how well it works in treating patients with recurrent high-grade glioma.~   "
240698|NCT00404235|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin~     together with ABI-007 works in treating patients with stage IV melanoma that cannot be~     removed by surgery.~   "
240699|NCT00404222|"~     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety~     of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release~     Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had~     a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged~     from the hospital.~   "
240700|NCT00404209|"~     To investigate the feasibility and advantages of using pressurized perfluorocarbon liquid~     (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual,~     dynamic drive (3D)technology, in complicated retinal detachment surgeries.~   "
240701|NCT00404196|"~     To compare the efficacy and safety of two different dose combinations of LEO19123 cream~     (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of~     patients with hand eczema.~   "
240702|NCT00404183|"~     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety~     of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a~     5-week dosing period in patients with osteoarthritis.~   "
240703|NCT00404170|"~     The purpose of this study is to investigate the utility of dopamine transporter imaging in~     monitoring and predicting the progression of Parkinson disease. This study will be performed~     in the PRECEPT cohort, an already existing cohort of 806 subjects recruited to participate in~     the study called, A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to~     Assess the Efficacy and Safety of CEP-1347 in Patients With Early Parkinson's Disease -~     (PRECEPT), sponsored by Cephalon and Lundbeck and coordinated by the Parkinson Study Group.~     The imaging data from this long-term PRECEPT follow-up study will allow us to evaluate the~     long-term progression of DAT loss in PD, the long-term follow-up of SWEDD subjects, the~     relationship between long-term clinical and imaging PD outcomes, and the relationship between~     long-term imaging outcomes and genetic and biochemical biomarkers of PD progression.~   "
240704|NCT00404157|"~     This is a Phase III, multicenter, extension study to evaluate the safety of rituximab~     administered on a scheduled basis approximately every 6 months. All subjects who complete~     their Week 52 visit in Study U2970g will be eligible for this study, as long as the inclusion~     and exclusion criteria are met.~   "
240705|NCT00404144|"~     The objective of this study is to assess the safety and efficacy of the Paclitaxel-eluting~     PTCA-balloon catheter (3µg/mm2 balloon surface area) in the treatment of significant (≥ 70%~     and < 100 %) stenoses in native coronary arteries with reference diameters from 2.25 mm to~     2.8 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency.~   "
240706|NCT00404131|"~     The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic~     Solution with placebo when applied topically in subjects with dry eye disease.~   "
240737|NCT00403728|"~     Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of~     a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the~     mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged~     ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at~     reperfusion in experimental models. The objective of the present study is to determine~     whether administration of CsA at reperfusion in patients with ongoing acute myocardial~     infarction treated by coronary angioplasty might reduce infarct size.~   "
240738|NCT00403715|"~     The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic~     Solution with Placebo when applied topically in subjects with dry eye disease.~   "
240707|NCT00404118|"~     Long-term care (LTC) can be defined as the range of institutional and home and~     community-based services that support individuals needing chronic care. The defining values~     of LTC in the VA include caring for patients in the least restrictive environment consistent~     with meeting a patient's needs. VA faces an increasing demand for these services with the~     growing number of veterans 85 years and older, those most in need of LTC. Yet in fiscal year~     2007, 87% of the 3.5 billion total VA dollars spent on LTC went to institutional care rather~     than the less restrictive Home and Community Based Services (HCBS). VA Central Office has~     formally committed to tripling the proportion of LTC that is HCBS between 1999 and 2011.~      Study Objectives: (1) Develop and test measures of patient/caregiver and provider~     satisfaction. (2) Develop and test measures of process and cost of the LTC referrals.~      Methods: Three VAMCs in VISN 11 are the study setting. This study was conducted from October~     2007-June 2010 and utilized a variety of data sources throughout this timeframe. Data sources~     included: the Geriatric Extended Care form, telephone and in-person interviews, online and~     paper surveys, Extended Care Screening Committee meeting minutes, and technical reports from~     the Health Economics Resource Center.~      Status: Complete.~   "
240708|NCT00404105|"~     The study compares the precision and accuracy of two laser refractive techniques, PRK and~     LASIK, for correction of nearsightedness between -6 and -8 diopters.~   "
240709|NCT00404092|"~     This study investigates the safety and tolerability as well as the efficacy and~     pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic~     malignancies and proven or probable invasive aspergillosis.~   "
240710|NCT00404079|"~     Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and~     degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability.~     Some indications exist for symptomatic and possible cartilage-structurmodifying effect on~     knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar~     spine is most likely to OA processes in knees and hips, hence GS could have comparable~     symptomatic and structural effect on lumbar OA.~      Study hypothesis: No difference in treatment effect exists between oral intake of GS- or~     placebo-capsules for patients` with chronic low back pain measured with Roland Morris~     Disability Questionnaire.~   "
240711|NCT00404066|"~     This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC)~     followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant~     treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to~     determine whether lapatinib combined with chemotherapy was safe and resulted in an increase~     in pathologic complete response rates.~   "
240712|NCT00404053|"~     In view of its safety profile and the results of clinical trials, clopidogrel has become the~     standard treatment for patients with acute coronary syndrome (ACS) and drug eluting~     stent(DES) implantation. Two large studies in patients with ACS shown that pretreatment with~     clopidogrel had beneficial effects. The pretreatment regimens were given a mean of 6 days~     before intervention in the observational PCI-CURE trial and 3 to 24 h in the randomized CREDO~     trial respectively. Accordingly, current clinical practice carries out pretreatment with a~     300mg loading dose of clopidogrel at least 6 h before DES implantation procedure in patients~     with ACS. Compared with the 300mg clopidogrel loading dose, 600mg loading dose exhibited a~     superior antiplatelet effect and improved short-term clinical outcomes in patients undergoing~     DES implantation for ACS according to recent a few publications. But despite clopidogrel~     600mg loading dose and the routine use of 75mg per day as a maintaining dose, recurrent~     ischemic events occurred in some patients. Therefore, the goal of this study will evaluate~     the efficacy of a 600mg loading dose of clopidogrel plus 150mg per day as a maintaining dose~     in patients with ACS undergoing DES implantation.~      ACS patients undergoing DES implantation who receive planned 600mg loading dose clopidogrel~     pretreatment are eligible for the study. All enrolled patients will be randomized to receive~     daily clopidogrel 75 mg or 150mg as maintaining doses starting as soon as post-PCI, in~     addition to daily aspirin 100 mg, and lasted for the first month after DES implantation. One~     month later, all patients receive daily clopidogrel 75mg until 9~12month after DES~     implantation. The primary endpoints include death of all causes, myocardial infarction,~     revascularization of the target lesson, sub-acute and late stent thrombosis one year after~     PCI, The secondary endpoints are major and minor bleeding events. The study will be powered~     to test the hypothesis that higher maintaining dose(150mg) of clopidogrel will reduce major~     adverse cardiac events compared to currently used common dose(75 mg) at one year following~     PCI.~   "
240713|NCT00404040|"~     This was a single centre study comprised of two stages (Parts I and II). Part II was a 12~     week randomised double blind comparison of Movicol and Lactulose Dry as maintenance therapy~     on an out-patient basis. The aim was to evaluate the safety and efficacy of Movicol in the~     treatment of faecal impaction in children~   "
240714|NCT00404027|"~     The purpose of this research study is to assess patient and provider attitudes towards the~     role that patients should play in medical decision making and self-management. We will~     examine the degree to which similarity of attitudes held by VA patients being treated for~     co-morbid diabetes mellitus and hypertension and by their primary care providers is a~     determinant of patient satisfaction, patient adherence, and adequacy of blood pressure and~     diabetic control.~   "
240715|NCT00404014|"~     The primary objective is to compare mild cognitive impairment in the AL-208 group with the~     placebo group at 14 + - 3 days after CABG surgery~   "
240716|NCT00404001|"~     The primary objectives of this study are to evaluate the safety of MD-0727 in patients with~     primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C)~     lowering effect and dose-response of MD-0727 in patients with primary hypercholesterolemia.~   "
240717|NCT00403988|"~     Study Objective :~      To assess the efficacy and the safety of the combination of Oxaliplatin, and Vinorelbine with~     or without Trastuzumab as a salvage regimen in patients with Metastatic Breast Cancer~   "
240718|NCT00403975|"~     The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol~     tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects~     with mild to moderate dry eye disease.~   "
240719|NCT00403962|"~     The purpose of this study is to assess the efficacy, safety and tolerability of a combination~     of Vestipitant and Paroxetine in patients with Social Anxiety Disorder (SAD)~   "
240720|NCT00403949|"~     The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment~     of mild to moderate perioral dermatitis.~   "
240721|NCT00403936|"~     This study was designed to determine whether a simple manipulative technique of relaxing the~     tissues of the occipito-atlantal junction in the neck had any effect on the activity of the~     sympathetic or parasympathetic nervous system. Subjects were dark adapted then measures of~     pupillary activity, reflecting autonomic nervous system activity were taken before and after~     treatment. The study hypothesis was that thet treatment technique would have no effect on the~     pupillary measures, hence indicating no effect on autonomic system activity.~   "
253012|NCT00239798|"~     This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and~     corticosteroids in patients receiving a kidney transplant.~   "
240722|NCT00403923|"~     The hypothesis underlying this study is that failure to recognise the role of lactose~     intolerance among patients with ulcerative colitis has led to inappropriate dietary advice~     and treatment with drugs that contain lactose as a filler. These failures exacerbate symptoms~     and lead to the unnecessary use of immune suppressant drugs.~      There is disagreement amongst researchers regarding the amount of lactose needed to cause~     symptoms in those who are lactose intolerance. The general consensus is that the amount of~     lactose in a glass of milk (12 grams) is enough to cause mild symptoms in most patients who~     are lactose intolerant (1). However, there have been a number of studies and case studies~     that argue that much lower amounts can cause symptoms (2, 3, 4, 5). This could be as little~     as 0.02 grams (6).~      Ulcerative colitis is a chronic relapsing inflammatory disease of the colon and rectum,~     characterised by recurrent episodes of abdominal pain and profuse diarrhoea. The prevalence~     of lactose intolerance in patients with ulcerative colitis is not greater than in the general~     population, but there is no evidence as to whether these patients are more sensitive to~     lactose.~      This study will identify the threshold at which symptoms of lactose intolerance develop in~     those who have both lactose intolerance and ulcerative colitis, to provide appropriate advice~     and treatment in the management of patients with these conditions.~   "
240723|NCT00403910|"~     The RALES study has shown that spironolactone reduces the risk of morbidity and mortality~     both from progressive heart failure and sudden death, in patients with NYHA III or IV heart~     failure. This favourable effect was clearly independent from a diuretic effect.~     Antialdosterone drugs may be effective because they opposes the effects of aldosterone on~     sodium retention, loss of magnesium and potassium, sympathetic activation, baroreceptor~     function and vascular compliance. Antialdosterone treatment may also antagonize the effect of~     aldosterone in promoting cardiac fibrosis. In a RALES substudy baseline serum PIIINP, a~     marker of cardiac fibrosis synthesis showed an independent negative correlation with survival~     and CHF hospitalizations in the placebo group. Therefore it seems interesting to evaluate the~     effect of an Aldosterone receptor blocker on progression of left ventricular dysfunction in~     patients with mild heart failure assuming standard therapy.~   "
240724|NCT00403897|"~     The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment~     of chronic constipation in children.~   "
240725|NCT00403884|"~     In this prospective clinical study SRT is performed with various pulse durations at 1.7µs and~     additionally 200ns to evaluate the different clinical effects of both laser regimens. The~     macular diseases to be treated are drusen maculopathy and geographic atrophy due to~     age-related macular degeneration as well as diabetic macular edema and central serous~     chorioretinopathy.~      The beneficial effect in laser treatment is thought to be associated with the restoration of~     a new barrier of retinal pigment epithelium cells. If this theory is true, the destruction of~     the photoreceptors causing visual field defects would be only an unwanted and unnecessary~     side effect. Thus, SRT is able to avoid these unintentional side effects and to achieve the~     benefit by just treating the RPE.~      In this study the clinical effect of SRT for these diseases is evaluated on a long-term~     basis.~   "
240726|NCT00403871|"~     Heart disease among pregnant women is increasing in incidence. The cardiovascular changes~     associated with pregnancy may be particularly hazardous for both mother and fetus in a subset~     of these patients. The period of greatest risk is peripartum while these patients are under~     the care of the obstetrician and anesthesiologist. We will evaluate the anesthetic management~     of all women with heart disease whose pregnancies were followed at the University Health~     Network and/or Mount Sinai Hospital between 1986 and 2001.~   "
240727|NCT00403858|"~     This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day~     open label evaluation of Movicol administered to patients in hospital. This study evaluated~     the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered~     over 3 - 7 days to achieve disimpaction.~   "
240728|NCT00403845|"~     The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol~     (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD)~     so that optimal dose(s) could be chosen for testing in later studies.~   "
240729|NCT00403832|"~     Cataract is a common complication in uveitis patients. Cataract operations with intraocular~     lens implantation are difficult in these patients because of complication due to the~     biocompatibility of the intraocular lens. In this study, uveal and capsular biocompatibility~     of two widely used acrylate intraocular lenses are compared.~   "
240730|NCT00403819|"~     A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an~     open label post study follow-up, to assess the efficacy and safety of Movicol in the~     treatment of chronic constipation in children~   "
240731|NCT00403806|"~     Adeno-tonsillectomy is a commonly performed surgical procedure in children. Main morbidities~     are postoperative pain, nausea and vomiting, and haemorrhage. Non-steroidal anti-inflammatory~     drugs (NSAIDs)widely used for paincontrol increase the risk of postoperative bleeding and~     reoperation. Dexamethasone is an powerful antiemetic and has shown analgesic efficacy.~     Antiemetic and analgesic dose-response has never been established.~   "
240732|NCT00403793|"~     Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a~     hormone and hormone injections in order to investigate the suppressive effect on sperm~     production and reversibility of sperm production after end of treatment.~   "
240733|NCT00403780|"~     The hypothesis behind the trial is the concept that Pregabalin is effective in reducing pain~     at rest in lower limb ischemia, and the study evaluates active treatment or placebo added to~     the regular pain regimens for these patients.~   "
240734|NCT00403767|"~     The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin~     for the prevention of blood clots in the brain (referred to as stroke) and blood clots in~     other parts of the body referred to as non-central nervous system systemic embolism) in~     patients with non-valvular atrial fibrillation (a heart rhythm disorder).~   "
240735|NCT00403754|"~     This study was designed to provide data about the safety and efficacy of 3 doses of~     indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or~     doses, could be chosen for testing in later studies.~   "
240736|NCT00403741|"~     Assesment the impact of three individuals consultations in adapted physical activity by type~     2 diabetics~   "
240740|NCT00403689|"~     Insoluble (1,3),(1,6)-beta-D-glucan from bakers yeast are indigestible polysaccharides.~     Previous studies indicate that the intake of insoluble dietary fiber is strongly associated~     with reduced risk of type 2 diabetes and cardiovascular disease. However, the mechanisms~     leading to this phenomenon are largely unknown.~      There are close relations between metabolic and inflammatory pathways, and a number of~     hormones, cytokines, signal proteins, bioactive lipids, and transcription factors have been~     shown to be involved in both systems.~      Beta-D-glucans have been suggested to play a role as so called biological response modifiers.~     Studies in animals indicate that even small doses of (1,3),(1,6)-beta-D-glucan may have~     beneficial effects on immune activity, i.e., by reducing the secretion of inflammatory~     factors.~      The investigators hypothesize that the intake of isolated (1,3), (1,6)-beta-D-glucan from~     bakers yeast improves inflammatory makers and insulin-sensitivity in overweight subjects with~     increased C-reactive protein concentrations at baseline.~   "
240741|NCT00403676|"~     Evaluate the effectiveness and acceptability of care given by nurse specialists in out~     patient clinics, through a randomized controlled study.~   "
240742|NCT00403663|"~     Combined spinal - epidural (CSE) anesthesia is a well established technique used for elective~     Cesarean section. As its name suggests, it combines two anesthesia techniques - spinal and~     epidural. Adjusting the dose of freezing medication for body size is not as simple as giving~     a larger dose to a larger person. This study asks a simple, yet important question: does your~     body mass index (BMI) influence the amount of freezing medication needed for adequate CSE~     anesthesia for Cesarean section? BMI is a number calculated from your height and weight. In~     patients with a higher BMI, freezing medication appears to spread farther (to a higher level)~     in the spinal fluid. When freezing is too high, it can cause unwanted side effects.~     Therefore, in order to provide optimal spinal anesthesia to patients with a higher BMI, it~     may be advisable to administer less freezing medication. In this study, we want to find the~     ideal dose of freezing medication for patients with a higher body mass index, and compare it~     to the dose found to be ideal for patients with normal body mass index.~   "
240743|NCT00403650|"~     This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension~     with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.~   "
240744|NCT00403637|"~     The study is designed to obtain safety and efficacy data on three dose levels of indacaterol~     when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1~     day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg,~     indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a~     washout-period of 1 week~   "
240745|NCT00403624|"~     Primary objective:~      - To evaluate the rate of responses to neoadjuvant therapy + radiotherapy~      Secondary objective:~      - tolerability (toxicity) and time to progression~   "
240746|NCT00403611|"~     The primary objective of this project is to evaluate the efficacy and safety of praziquantel~     60 mg/kg in the treatment of schistosomiasis, as compared to the standard 40 mg/kg therapy in~     a representative community from a highly endemic area of schistosomiasis in Northeastern~     Brazil. Cure rates, reduction in egg counts and proportions of reported side-effects in~     children at the 10-19 y age-range with at least 100 eggs per gram of faeces will be compared~     between regimens, aiming to evaluate the superiority of 60 mg/kg over the 40mg/kg dose~     currently recommended by the WHO. Reinfection rates will also be evaluated aiming to improve~     transmission control within the local health system, including re-treatment combined with~     auxiliary control measures. Features related to the clinical, nutritional and immunological~     status of the patients prior to treatment will also be investigated in association with the~     outcome of praziquantel treatment.~   "
240747|NCT00403598|"~     The purpose of this study is to determine whether the serum levels of certain calcium-binding~     proteins may be helpful in the diagnosis and management of metabolic bone diseases.~   "
240748|NCT00403585|"~     This is an open label, single-arm, multi-centre extension study for Korean patients with~     chronic hepatitis B and compensated liver disease who have completed one-year adefovir~     dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of~     long term (up to 3 years) adefovir dipivoxil 10mg therapy.~   "
240749|NCT00403572|"~     The purpose of this study is a systematical registration of hemodynamic measurements (cardiac~     output, blood pressure and systemic vascular resistance) in women with serious preeclampsia.~   "
240750|NCT00403559|"~     This is an exploratory study to determine effectiveness of Elidel for the treatment of~     seborrheic dermatitis~   "
240751|NCT00403546|"~     The primary aims of this study are to assess tolerability of ziprasidone dose escalation to~     320 milligrams per day (mg/d) compared to continued standard treatment (placebo) as measured~     by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes~     Akathisia Scale (BAS), serum prolactin concentrations, vital signs, electrocardiogram (EKG)~     and completion rates and to assess whether ziprasidone dose escalation improves overall~     psychopathology compared to continued standard treatment as measured by the change from~     baseline in the Positive and Negative Syndrome Scale (PANSS) total score and response rates~     as defined by a 20% or greater reduction in PANSS total score.~      The secondary aims of this study are to assess whether ziprasidone dose escalation improves~     psychotic symptoms compared to continued standard treatment as measured by the Positive~     Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves~     negative symptoms compared to standard treatment as measured by the Negative Symptom Subscale~     of the PANSS, to assess whether ziprasidone dose escalation improves depressive symptoms~     compared to continued standard treatment as measured by the Calgary Depression Rating Scale~     (CDRS), and to assess whether ziprasidone dose escalation improves overall functioning with~     the Clinical Global Impression - Severity (CGI-S), Clinical Global Impression - Improvement~     (CGI-I), Global Assessment of Functioning (GAF) and the Schizophrenia Cognition Rating Scale~     (SCoRS).~   "
240752|NCT00403533|"~     We hypothesize that atorvastatin will decrease HCV viral load in patients taking the~     medication.~      Cholesterol is needed for HCV virion production. Cell culture studies have shown that~     atorvastatin (an HMG-CoA reductase inhibitor) decreases HCV viral replication. As~     atorvastatin has been proven to decrease heart attack and stroke in patients with high~     cholesterol, this medication is indicated for the treatment of elevated cholesterol in at~     risk individuals. Therefore we propose to study the effect atorvastatin has on the viral load~     of patients initiated on atorvastatin therapy for their elevated cholesterol.~   "
240754|NCT00403507|"~     The purpose of the study is to determine if participation in an exercise program helps memory~     loss from getting worse, and if it improves daily functioning and attitudes of those with~     probable Alzheimer's disease. It will involve participation of both the person with memory~     loss and someone who knows their daily activities (e.g., husband, wife, adult child, or~     caregiver).~   "
240755|NCT00403494|"~     The purpose of this study is to evaluate whether 6R-BH4 (sapropterin dihydrochloride) is safe~     and effective in the treatment of intermittent claudication (IC) caused by peripheral~     arterial disease (PAD).~   "
240756|NCT00403481|"~     This study will examine the ability of olmesartan medoxomil to lower the blood pressure of~     patients with Type II diabetes and high blood pressure. The medication being tested has been~     approved by the FDA for the treatment of high blood pressure.~   "
240757|NCT00403455|"~     Dr. Wang's merit review is aimed at providing a better understanding of the relationship~     between SLC6A3/SLC6A4 and the mental health of veterans exposed to high levels of combat~     stress, specifically focusing on PTSD symptoms, related co-morbidities, treatment outcomes~     and seeks new approaches to therapy for our Veteran population.~   "
240758|NCT00403442|"~     The purpose of this study is to explore the combination of PDT with verteporfin at reduced~     and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal~     CNV of all subtypes with a high percentage of subretinal hemorrhage (hemorrhage >50% of total~     lesion area).~      To assess the safety of bevacizumab in combination with verteporfin PDT (reduced fluence: 300~     mW/cm2) as compared to bevacizumab in combination with verteporfin PDT (standard fluence: 600~     mW/cm2) in patients whose neovascular CNV lesions containing >50% blood.~   "
240759|NCT00403429|"~     The purpose of this study is to evaluate the activity and the toxicity of capecitabine as~     monotherapy in the treatment of platinum resistant or refractory ovarian cancer.~   "
240760|NCT00403416|"~     This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections~     after kidney transplantation, when combined with tacrolimus for the first 3 months and with~     myfortic thereafter.~   "
240761|NCT00403403|"~     This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary~     evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or~     carboplatin) and etoposide in patients with previously untreated extensive-stage small cell~     lung cancer (SCLC).~   "
240762|NCT00403390|"~     This study compares two different brands of thyroxine (thyroid hormone). Currently,~     pharmacists may be substituting generic formulations of thyroid hormone without your doctor~     knowing about this. Although a small difference in thyroid function is not significant in~     most healthy children, adolescents and adults, in infants and toddlers even a small~     difference in thyroid function can have important harmful consequences on brain development.~     The purpose of the present study is to learn whether the difference between brands of thyroid~     hormone that are currently being substituted is sufficient to cause a difference in thyroid~     function.~   "
240763|NCT00403377|"~     RATIONALE: Understanding why sunbathers use or don't use sunless tanning products may help~     doctors plan effective ways to prevent skin cancer caused by sunbathing.~      PURPOSE: This phase I/II trial is studying attitudes about the use of sunless tanning~     products and how well sunless tanning products work as a substitute for sunbathing in healthy~     participants.~   "
240764|NCT00403364|"~     To assess if a sequential treatment regimen better eradicates H. pylori than does a triple~     drug regimen in adults with dyspepsia or peptic ulcer disease.~   "
240765|NCT00403351|"~     Estimating the risk of future cardiovascular events such as death, stroke and myocardial~     infarction using traditional risk factors (such as age, gender, smoking, diabetes,~     hyperlipidaemia and hypertension) is well accepted in patients with and without existing~     cardiovascular disease. These estimates are based on a number of robust observational~     studies, including the original Framingham study. While these methods apply reasonably well~     on a population level their application to the individual patients is not always~     straightforward. In addition, risk charts, such as those published by the Joint British~     Societies and American Heart Association, may underestimate risk in certain groups, notably~     diabetics and patients of Indo-Asian background, whilst overestimating risk in others (by as~     much as 50% in some studies).~   "
240766|NCT00403338|"~     1500 eligible patients will be treated with the commercially available CYPHER®~     sirolimus-eluting Bx Velocity™ stent. Patients will be followed to twelve months~     post-procedure, watching for patients that require a repeat procedure on the same diseased~     area of the coronary artery.~   "
240767|NCT00403325|"~     The purpose of this study is to examine the effects of Lucentis for active Central Serous~     Chorioretinopathy.~   "
240768|NCT00403312|"~     Cigarette smoking is the most common risk factor for lung cancer, and it increases the risk~     of developing other cancers, chronic lung disease, and heart disease. A smoking cessation~     program that incorporates physical activity may be beneficial in improving long-term smoking~     cessation rates. This study will evaluate the effectiveness of a community-based physical~     activity program, in combination with nicotine replacement therapy and a behavioral smoking~     cessation program, at improving cessation rates among sedentary smokers.~   "
240769|NCT00403299|"~     Heart transplanted patients often develop coronary artery disease and therefore have their~     coronary arteries examined with coronary angiography once a year.The purpose of the study is~     to validate computer tomography of the coronary arteries against coronary angiography and~     intravascular ultrasound in heart transplanted patients. Additionally the association between~     different inflammatory markers and the development of CAD specific to heart transplanted~     patients will be studied.~   "
240770|NCT00403286|"~     The purpose of the study is to determine the appropriate dose of fluticasone~     propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone~     propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in~     blood plasma in patients with chronic obstructive pulmonary disease.~   "
240867|NCT00402025|"~     The purpose of the study is to assess the safety of injections of talimogene laherparepvec~     into patients with pancreatic cancer that cannot be removed by surgery. The study will also~     test whether the injections are effective in treating the tumor.~   "
240868|NCT00402012|"~     This study is designed to look at the effect of Pioglitazone treatment on the body's ability~     to burn food in order to produce energy.~   "
240771|NCT00403273|"~     Primary Total Knee joint replacement surgery is highly successful surgery for relieving pain~     and improving function in patients with disabling arthritis. Unfortunately, like all~     biomedical devices, prosthesis failure is a complication of knee replacement surgery that~     leads to disabling pain, stiffness and loss of function. Approximately 1% of the knee~     replacements fail every year leading to a 20% failure rate over 20 years. The common causes~     of failure of prosthetic joint are infection, loosening, trauma or wear of the prosthesis.~     Currently, a revision surgery is the best option for long term pain relief (analgesics or~     other pain medications are options but are of limited benefit). Surgery may not be feasible~     in patients due to advancing age, other medical conditions and surgical/technical~     difficulties or patient's choice. In addition, the results from revision surgery are not as~     good as the initial knee joint surgery. Therefore, there is a great need for a novel,~     targeted therapy that provides an option to patients who are unfit, unable, or unwilling to~     undergo surgery.~      In the investigators' recent pilot study, a single injection of Botulinum toxin A (Botox) in~     painful natural knee, ankle and shoulder joints of patients with various types of arthritis~     led to significant and durable improvement in pain and function and was safe to use. The~     investigators propose this 6-month study to compare pain relief, improvement of function and~     safety of an injection of Botulinum toxin compared to placebo in patients with a painful~     prosthetic knee joint. Both patients and investigators will be blinded to the treatment~     assignment to a patient until the study is completed. The investigators will assess the~     amount and duration of pain relief, improvement in function and short term safety of~     Botulinum toxin using standard validated measures. Patients will be evaluated at baseline, 2~     weeks, 1-, 2-, 3-, 4- and 6-months after a single injection of either placebo or BoNT/A in~     the hip or knee prosthesis. The six-month follow-up is to assess the duration of meaningful~     pain relief. If successful, this will offer a new treatment option for patients with a~     chronically painful knee prosthetic joint, provide more insight into the origin and cause of~     pain in prosthetic joints and direct future investigations in new directions.~   "
240772|NCT00403260|"~     The primary objective of this phase III study is to compare the efficacy and safety of the~     fixed combination of pyronaridine artesunate (180:60 mg) with that of the combination of~     mefloquine plus artesunate in children and adults with uncomplicated P falciparum malaria.~   "
240773|NCT00403247|"~     The purpose of this study is to determine whether individuals with schizophrenia who will~     take a high dose of the B-vitamins folate, B12 and pyridoxine, may experience improvement in~     their symptoms.~   "
240774|NCT00403234|"~     The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal~     system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2)~     the impact of BTDS on functional rehabilitative measures after total knee replacement~     surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind~     treatment period is for 28 days during which time supplemental analgesic medication will be~     provided to all subjects in addition to study drug.~      Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to~     efficacy or safety. The focus of this study became safety evaluations.~   "
240775|NCT00403221|"~     The purpose of this study is to conduct a Phase I clinical trial involving in situ RTVP-1~     gene therapy for prostate cancer. We will conduct necessary safety evaluations on a new~     adenovirus that contains the human genes for RTVP-1. This virus will then be evaluated for~     safety in men with prostate cancer prior to radical prostatectomy. Based on the preclinical~     data, we hope that this treatment will induce not only a local cytotoxic and antiangiogenic~     effect but also, a systemic antitumor immune response capable of eradicating micrometastatic~     disease (the reason for recurrence in many of these patients).~   "
240776|NCT00403208|"~     Hypothesis: A protocolized algorithm for sedation in critically ill patients on mechanical~     ventilation can decrease ventilator days, costs and improve outcome.~      This is a multicenter observational-interventional study on critically ill patients who~     require mechanical ventilation for more than 48 hours, involving 13 ICU in Chile. There are~     two periods (groups): a descriptive phase of sedation practices, and an interventional period~     in which an analgesia-based, goal-directed, nurse-driven sedation is applied.~      Main outcome: ventilator-free days between both periods.~   "
240777|NCT00403195|"~     The purpose of this study is to characterize the disease Ocular Ischemic Syndrome.~   "
240778|NCT00403182|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Estrogen can cause the~     growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by~     lowering the amount of estrogen the body makes. It is not yet known whether giving~     chemotherapy before hormone therapy is more effective than giving hormone therapy before~     chemotherapy in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying chemotherapy to see how well it works~     when given before or after hormone therapy as first-line therapy in treating postmenopausal~     women with metastatic or locally advanced breast cancer.~   "
240779|NCT00403169|"~     RATIONALE: Lenalidomide may stop the growth of kidney cancer by blocking blood flow to the~     tumor.~      PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients~     with advanced or unresectable kidney cancer.~   "
240780|NCT00403156|"~     The purpose of study is to determine if Lucentis combined with imatinib mesylate will help~     treatment in patients with newly diagnosed choroidal neovascularization.~   "
240781|NCT00403143|"~     To measure colour vision in patients with a blue light filtering lens implant in one eye and~     non-tinted implant in the other eye (and compared this group with a control group with~     bilateral non-tinted implants) and to determine whether blue light filtering lenses limit~     colour vision~   "
240782|NCT00403130|"~     Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and~     bevacizumab for patients with metastatic neuroendocrine tumors.~   "
240783|NCT00403117|"~     The purpose of this study is to determine if the subjective effects of marijuana will be~     decreased by low-doses (< 25 mg) of naltrexone and increased by high-doses (> 50 mg) of~     naltrexone.~   "
240784|NCT00403104|"~     The purpose of this study is to determine if oral treatment with ONO-2506PO in patients~     diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization,~     could lead to the slowing of decline in respiratory function, functional status, muscle~     strength, quality of life and survival compared with placebo group.~   "
240785|NCT00403091|"~     Rural Diabetes Online Care (RDOC) will develop an Internet-based intervention for rural~     primary care physicians, focusing on improving care for adult patients with diabetes. The~     intervention, drawing upon the principles of quality improvement and providing tools for~     system-based changes in practice, is designed for the rural practice, where resources are~     constrained.~   "
240786|NCT00403078|"~     The primary objective of this study is to assess the outcomes of stenting with distal~     protection in the treatment of obstructive carotid artery disease. The devices to be utilized~     are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP~     Emboli Capture Guidewire (ECGW).~   "
240787|NCT00403065|"~     RATIONALE: Steroid therapy, such as dexamethasone, may reduce swelling, pain, and other~     symptoms of inflammation and may be effective in treating some of the problems caused by~     cancer and cancer treatment. Supportive care improves the quality of life of patients with a~     serious or life-threatening disease, and prevents or treats symptoms of cancer, side effects~     of treatment, and other problems related to cancer or its treatment. Radiation therapy uses~     high-energy x-rays to kill tumor cells. It is not yet known whether dexamethasone given~     together with supportive care is more effective with or without whole-brain radiation therapy~     in treating patients with brain metastases.~      PURPOSE: This randomized phase III trial is studying dexamethasone and supportive care to see~     how well it works with or without whole-brain radiation therapy in improving the quality of~     life of patients with non-small cell lung cancer that has spread to the brain and cannot be~     removed by surgery.~   "
240788|NCT00403052|"~     The main objectives of this study are to establish a safe, tolerable and active dose of 1018~     ISS administered in combination with irinotecan and cetuximab in patients with metastatic~     colorectal cancer. Other objectives also include determining tumor response, time to disease~     progression, and overall survival in treated patients.~   "
240789|NCT00403039|"~     The purpose of this study is to examine the effects of Lucentis for active Central Retinal~     Vein Occlusion with Macular Edema~   "
240790|NCT00403026|"~     Bevacizumab is an anti-VEGF agent used in approved for use in metastatic colorectal carcinoma~     (FDA Approved). This study analyzes the safety and efficacy of off-label Intravitreal~     Injection of bevacizumab (Avastin) for CNVM, Macular oedema due to diabetic retinopathy,~     vascular occlusion and other retinal disorders.~   "
240791|NCT00403013|"~     The purpose of this study is to determine whether the axillary plexus block performed in~     lateral, head down position is effective in the perioperative analgesia in patients scheduled~     for elective surgery of the shoulder.~   "
240792|NCT00403000|"~     RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with~     recurrent prostate cancer that did not respond to androgen-deprivation therapy.~   "
240793|NCT00402987|"~     We are proposing a study in which we utilize and augment the sore throat pain model to assess~     the analgesic effectiveness of celecoxib compared to placebo in patients with painful~     pharyngitis under randomized, double-blind, placebo-controlled conditions.~   "
240794|NCT00402974|"~     Background of the study:~      Results from several studies show that vitamin K has an important function in bone~     metabolism. In a previous cross-sectional study conducted by our department, evidence for a~     poor vitamin K status of bone during growth in children was found (unpublished data, accepted~     for publication Pediatric Research, october 2006). These findings justify clinical~     intervention studies in which bone quality is monitored as a function of long-term vitamin~     K-supplementation. Before a long-term intervention study is undertaken, it is important to~     determine the effect of vitamin K administration on osteocalcin carboxylation in this~     specific population. Although the relationship between increased vitamin K intake and~     osteocalcin carboxylation was already clearly demonstrated in several adult groups (e.g.~     healthy adults, postmenopausal women), this has never been shown in children.~      Objective of the study:~      To study the effect of a vitamin K-containing food supplement (menaquinone 7) on osteocalcin~     carboxylation in healthy children between 6 and 10 years of age in the Netherlands.~      Study design:~      Randomised double-blind placebo-controlled intervention study.~      Study population:~      55 healthy children (boys and girls) between 6 and 10 years, recruited from primary schools.~      Intervention:~      The subjects are randomised into two groups:~        -  placebo group: during 8 weeks, 27 children will receive one tablet of placebo- food~          supplement per day~        -  treatment group: during 8 weeks, 28 children will receive one tablet of food supplement~          per day containing 45 µg vitamin K2.~      Primary study parameters/outcome of the study:~      Undercarboxylated (ucOC) and carboxylated (cOC) fractions of osteocalcin will be measured by~     enzyme-linked immunosorbent assay (ELISA). Both the ucOC fraction and the ucOC/cOC ratio~     (UCR) are sensitive indicators for the vitamin K status of bone. Elevated levels of UCR are~     indicative of an inferior vitamin K status of bone. The main study parameters are the mean~     percentages of change in serum undercarboxylated osteocalcin (ucOC) and UCR from baseline~     (t=0) to endpoint (t=8 weeks) in both treatment groups.~      Secondary study parameters/outcome of the study (if applicable):~      The secondary end points are the percentages of change in serum vitamin K levels in relation~     to lipid metabolism markers from baseline to endpoint in each individual.~      Furthermore, the percentages of changes in serum BAP and NTX from baseline to endpoint in~     each individual are considered to be endpoints as well.~   "
240795|NCT00402961|"~     The purpose of this study is to see whether acupuncture may help patients recover from colon~     cancer surgery.~   "
240796|NCT00402948|"~     This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug~     TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged~     between 18-65, non-smokers . The study will also look at the nature and quantity of~     inflammatory white cells in the lung secretions and in the blood, and some additional~     inflammation markers.~   "
240797|NCT00402935|"~     RATIONALE: Comparing results of diagnostic procedures, such as ultrasound, done before,~     during, and after chemotherapy may help doctors learn about the side effects of chemotherapy~     and help plan the best treatment.~      PURPOSE: This clinical trial is studying ovarian damage in young premenopausal women~     undergoing chemotherapy for cancer.~   "
240798|NCT00402922|"~     Coronary heart disease (CHD) is the leading cause of death in the United States. One common~     risk factor for CHD is obesity. The presence of certain types of fat over others is more~     commonly associated with the development of CHD. This study will use data from a previous~     study to examine the association between pericardial fat, a type of fat that surrounds the~     heart, and CHD.~   "
240799|NCT00402909|"~     This study will assess the safety and efficacy of adding nateglinide to treatment with basal~     insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for~     patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin~     and/or thiazolidinedione only.~   "
240800|NCT00402896|"~     The goal of this clinical research study is to learn the effect of ZD6474 on the amount of~     time between placement of an indwelling pleural catheter and the catheter's removal in~     patients with malignant pleural effusion.~      This study will also look at the effect that ZD6474 has on tumor cells, biological~     characteristics of cells in the body, rate of fluid build-up around the lungs, tumor size,~     and thickness of blood vessels. The effect that this drug has on quality of life and~     shortness of breath will also be examined.~   "
240801|NCT00402883|"~     The purpose of this study is to see if this combination of chemotherapy plus radiation~     therapy and immunotherapy (with bevacizumab) expands treatment options for patients with~     non-small cell lung cancer.~   "
240802|NCT00402870|"~     The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to~     increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of~     gastric insufflation and insertion of a gastric tube. In the following randomized prospective~     double-blind trial, we test the hypothesis that the postoperative analgesic requirements is~     higher for the ProSeal laryngeal mask airway than the tracheal tube.~   "
240804|NCT00402844|"~     Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic~     organs and vaginal walls to protrude. For decades, suture repair techniques have been the~     primary choice of surgical treatment when indicated.~      The notion of reinforcing pelvic floor defects using biomaterial implants is not an~     exclusively contemporary idea. Traditional surgical techniques are frequently associated with~     unsatisfying anatomical recurrence rates and over the years sporadic attempts have been made~     to introduce novel surgical techniques using a variety of biomaterials as support with~     varying success. It is plausible that inherently weak, or damaged, pelvic floor supportive~     tissues need to be reinforced by a permanent support to avoid the high rates of recurrences~     commonly described using traditional techniques. However, use of biomaterials in pelvic~     reconstructive surgery has become widespread in just a few years despite a lack of clinical~     safety data, or compelling clinical evidence demonstrating that it improves outcomes compared~     to traditional suture techniques.~      It is likely that biomaterials need to be anchored in tissues not afflicted by the disease,~     in order to provide the intended pelvic floor support. This has given rise to transvaginal~     surgical techniques using a transobturator approach passing the mesh through the arcus~     tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach.~     Already commercially available implant materials are in need of patient safety documentation,~     both when considering the surgical techniques by which these materials are placed in the body~     as well as the actual materials. Complication rates and perioperative morbidity using these~     surgical routes in pelvic organ prolapse surgery are generally unknown.~      The aim of the present study was to assess the long term morbidity, and describe the~     complications, associated with transvaginal mesh repair of pelvic organ prolapse using the~     PROLIFT®-system.~   "
240805|NCT00402831|"~     Primary objective:~      To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two~     doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in~     terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days~     following the second dose of ProQuad®~      Secondary objectives:~        -  To describe the antibody response rates to measles, mumps, rubella and varicella~          measured 30 days following the first dose of ProQuad® administered by IM or SC route,~        -  To describe the antibody titres to measles, mumps, rubella and varicella at 30 days~          following the first dose and at 42 days following the second dose of ProQuad® both~          administered by IM or SC route,~        -  To describe the safety profile of two doses of ProQuad® both administered by IM or SC~          route.~   "
240806|NCT00402818|"~     RESTORE is an observational, open-label, multi-center, prospective, study enrolling Raptiva®~     (efalizumab) treated patients with moderate to severe chronic plaque psoriasis. The overall~     duration of the study is approximately 4 years. Patients will be followed from the time of~     study enrolment to study/treatment termination; thus active follow-up period will vary across~     subjects. Raptiva® (efalizumab)treated patients with moderate to severe chronic plaque~     psoriasis and meeting the inclusion/exclusion criteria specified will be eligible for~     participation in this study.~      Objectives:~        -  To document and quantify the incidences of adverse events in this patient population~        -  To explore the association of psoriasis treatments with changes in patient outcomes,~          quality of life, and treatment compliance.~   "
240807|NCT00402805|"~     The purpose of this study is to test the specific humoral response after an intramuscular and~     intradermal influenza vaccination in lung transplant recipients~   "
240808|NCT00402792|"~     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety~     of the administration of Extended-Release Hydrocodone/Acetaminophen compared to placebo over~     a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the~     safety of the drug for 7 days after patients are discharged from the hospital.~   "
240809|NCT00402779|"~     The goal of this clinical research study is to learn if erlotinib hydrochloride (Tarcevaâ~     (OSI-774 ) can prevent cancer in the mouth of people with a high risk of developing cancer in~     the mouth. The safety of this drug will also be studied, as well as the drug's effect on~     different cells in the body.~   "
240810|NCT00402766|"~     Primary Objective:~        -  To determine the maximum tolerated dose of the combination of cisplatin, imatinib~          mesylate, and pemetrexed in metastatic malignant mesothelioma.~      Secondary Objectives:~        -  To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor~          tissue by:~        -  histologic analysis of biopsy tissue~        -  by non-invasive assessments of tumor vascularity performed before, during and after~          treatment~        -  electron microscopy analysis of endothelial cell architecture after patient treatment~          with imatinib mesylate~        -  To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate~          markers in serum.~        -  To assess the rate of response to therapy.~        -  To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and~          pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor~          (PDGF-R) on malignant mesothelioma tumor cells.~        -  To determine the pharmacokinetic interaction between agents in this combination regimen.~   "
240811|NCT00402753|"~     The proposed study in an inception cohort of patients with hematological malignancies treated~     with PBSCT is designed to evaluate the effects of a physical exercise intervention on~     muscular-skeletal, physical activity and quality of life outcomes.~   "
240812|NCT00402740|"~     The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid~     Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange~     Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic~     Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease~     in high-surgical risk subjects.~   "
240813|NCT00402727|"~     Patients, who are considered suitable by their physicians to take part in this research, will~     have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples~     taken, as well as a sample of the secretions or tissue around their infection site. In~     addition, the site of the infection will be photographed. The patients will be randomly~     assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under~     evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e.,~     one of the reference treatments for this kind of infection). The maximum treatment duration~     will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients~     will have a physical examination every day. On Day 3-5 during therapy as well as at the end~     of treatment, the patients will have repeated examinations. These tests and evaluations will~     be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine~     samples will be taken only if judged necessary by the physicians.~   "
240994|NCT00400348|"~     The purpose of this study is to evaluate the efficacy, limited pharmacokinetics (PK), and~     safety of 1,000 mg of Panzem® NCD administered orally four times a day to patients with~     recurrent or resistant epithelial ovarian cancer.~   "
253013|NCT00239785|"~     This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and~     corticosteroids in patients receiving a kidney organ transplant~   "
240814|NCT00402714|"~     This is a study to explore the use of a reduced intensity transplant conditioning regimen. A~     conditioning regimen is the treatment that is given to prepare a body for the new bone marrow~     that will be received from a donor. Reduced intensity conditioning uses lower doses of~     chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and~     radiation cause fewer side effects. Reduced intensity regimens have been offered to older~     patients or patients at increased risk for transplant-related side effects and have been~     shown to be safe and effective. Reduced intensity conditioning regimens are now considered~     for many patients who are undergoing transplant.~   "
240815|NCT00402701|"~     The purpose of this study is to determine whether a walking school bus program can increase~     the number of children walking to school and decrease the number of children driven by car to~     school.~   "
240816|NCT00402688|"~     The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg~     for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the~     treatment of chronic prostatitis.~   "
240817|NCT00402675|"~     In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.~      Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and~     others even showed a benefit of a selective invasive approach only in case of recurrence of~     symptoms or a positive stress test.~      The optimal timing of intervention is still matter of debate as a result of a randomized~     clinical trial.~   "
240818|NCT00402662|"~     The purpose of this study is to determine if the combination of everolimus and imatinib will~     slow the growth of or cause a reduction in the size of the cancer, and to determine the side~     effects of the combination in patients with melanoma. Each of the drugs in this combination,~     if used alone, would not be expected to have an effect against the cancer. However, when used~     together, there is a possibility that they could work together to damage the cancer cells, or~     to block the formation or function of the blood vessels that feed the cancer, either of which~     could result in slowing the growth of or shrinking the cancer. Both drugs work by blocking~     signals that are sent from outside of a cell to the inside of the cell that direct the cell~     to make certain substances to keep the cell alive. Cancer cells or blood vessels that feed~     cancer cells may be more sensitive to drugs that block these signals.~   "
240819|NCT00402649|"~     This study may provide safety information on a flu vaccine given to children and may provide~     immunogenicity information to add to what was collected in a previous flu vaccine study.~     Participants will include 55 healthy children, ages 2-10, who participated in 04-077 and~     received a placebo injection instead of the flu vaccine or were incompletely immunized. The~     study has 2 purposes: to make sure there are no serious side effects in children and to see~     how the immune systems react to the vaccine. Study procedures include up to 4 study visits,~     up to 9 follow-up phone calls, 2 blood samples to be collected during visits 1 and 3, and up~     to 3 vaccine injections in the arm or thigh muscle. Parents will be given a memory aid card~     to record side effects, temperatures, and medications. Parents will have the option for the~     child to receive a 3rd dose of vaccine if offered, at month 6. This booster shot will require~     a 6-month visit and participation for an additional 6 months.~   "
240820|NCT00402636|"~     The purpose of this study is to evaluate whether adding estradiol to rapamycin better~     prevents coronary artery reblockage after drug-eluting stent implantation.~   "
240821|NCT00402623|"~     The exact cause of the chronic lung disease sarcoidosis is still unknown. Consequently, a~     complete efficacious treatment is still not available. Earlier studies indicate an important~     key role for oxidative stress, i.e. an imbalance between the production of and the protection~     against ROS, in the etiology of sarcoidosis. Antioxidants, needed for protection against ROS,~     are indeed lower in sarcoidosis. Therefore, antioxidant therapy to strengthen the reduced~     antioxidant defense might be efficacious in sarcoidosis treatment. Since ROS are also capable~     of initiating and mediating inflammation, antioxidant therapy might also mitigate the~     elevated inflammation that occurs in sarcoidosis. The flavonoid quercetin possesses both~     anti-oxidative and anti-inflammatory capacities and might therefore serve as a good candidate~     for antioxidant therapy in sarcoidosis.~      Therefore, the aim of the present study is to determine the effect of quercetin~     supplementation in sarcoidosis patients on markers of both oxidative stress and inflammation.~   "
240822|NCT00402610|"~     INTRODUCTION. To evaluate the efficacy of three regimens of prophylactic therapy for~     tuberculosis in HIV-infected patients with anergy. METHODS. Prospective, multi-center,~     randomized, comparative, and open clinical trial. Anergy was defined as absence of induration~     in response to three antigens (PPD, Candida albicans and parotiditis antigen) applied by the~     Mantoux method. Patients were randomized into one of the following prophylactic treatment~     groups: isoniazid for six months (6H), rifampin plus isoniazid for three months (3RH),~     rifampin plus pyrazinamide for two months (2RZ) or no treatment (NT). After completion of~     treatment, patients were followed up for two years.~   "
240823|NCT00402597|"~     The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent~     acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the~     occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions,~     stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.~   "
240824|NCT00402584|"~     The purpose of this study is to examine the safety and efficacy of sibutramine in preventing~     binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of~     sibutramine in reducing body weight in subjects with binge-eating disorder.~   "
240825|NCT00402571|"~     The study objective was to determine whether liver injury develops in alcoholic patients who~     ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from~     two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3~     consecutive days and remain in the facility an additional 2 days for monitoring. The primary~     measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that~     there would be no difference in aminotransferase measures between the acetaminophen and~     placebo study groups.~   "
240995|NCT00400335|"~     The combination of testosterone and dutasteride is intended for use in hypogonadal men. This~     study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone~     administered with and without dutasteride~   "
253163|NCT00237757|"~     The purpose of the study is to determine if 1. Rehabilitation staff can be trained to work~     better together as a team; and 2. Better team work improves patient outcomes.~   "
240826|NCT00402558|"~     The goal of this clinical research study is to determine the safety and effects of giving a~     special kind of immune cells called alloreactive natural killer (NK) cells with high dose~     chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining~     the maximum tolerated dose of NK cells. The NK cells will be donated from a relative of yours~     who has certain genetic type in their blood called HLA, that almost matches yours. The stem~     cells you will receive will come from a separate HLA matched (HLA A, B, C, DR) relative or~     unrelated donor. The safety of this treatment will also be studied.~   "
240827|NCT00402545|"~     The purpose of this research study is to determine the safest and most effective dose of 5-FU~     that can be given with docetaxel (Taxotere), Cisplatin and cetuximab to patients with newly~     diagnosed locally advanced squamous cell carcinoma of the head and neck. We will also be~     studying the toxicity of this regimen of 4 drugs and the tumor response.~   "
240828|NCT00402532|"~     The purpose of this study is to determine whether Everolimus is effective in the treatment~     and prevention of chronic graft dysfunction and chronic graft rejection after lung~     transplantation.~   "
240829|NCT00402519|"~     To assess the role of interstitial brachytherapy alone compared to whole breast irradiation~     in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning~     local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control~     rates in each arm are equivalent.~   "
240830|NCT00402506|"~     The purpose of this study is to determine the effect of MC-1 on the combined incidence of~     cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days~     following coronary artery bypass graft (CABG) surgery compared with placebo.~   "
240831|NCT00402493|"~     The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal~     Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using~     Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.~   "
240832|NCT00402480|"~     The purpose of this study is to assess prospectively the efficacy of hydroxyurea therapy in~     the setting of cerebrovascular disease, manifest as conditional or abnormal transcranial~     doppler ultrasonography (TCD) flow velocities, in children with sickle cell anemia (SCA). TCD~     is used to measure flow velocity in intracranial arteries as a marker of increased stroke~     risk in children with SCA. The primary objective of this protocol is to determine whether~     hydroxyurea reduces elevated TCD velocity.~   "
240833|NCT00402467|"~     The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It~     directly inhibits factor Xa, a blood component in the pathway which leads to coagulation~     (clotting of blood cells). It is available as a tablet. The purpose of this study is to~     compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed~     drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used~     in the area of thromboprophylaxis and will be given once daily subcutaneously. In this study~     4 different doses of the investigational drug BAY59-7939 will be tested in comparison to~     Enoxaparin. You will receive during the study either one of the following BAY59-7939~     treatments or Enoxaparin. The following doses of BAY59-7939 will be tested: Dose I ; Dose II,~     Dose III, Dose IV. This study will run for approximately 7 months in a number of countries.~     In total, up to 600 patients may participate in this study.~   "
240834|NCT00402454|"~     To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB)~     in HIV-infected patients with positive tuberculin skin test.~   "
240835|NCT00402441|"~     Primary Objective:~        -  To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in~          increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of~          treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal.~      Secondary objectives:~        -  To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in~          increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1~          year of treatment in women who are 0.5-5 years postmenopausal~        -  To assess the general safety of 35-mg risedronate administered once weekly.~   "
240836|NCT00402428|"~     This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of~     albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon~     alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic~     hepatitis C, genotype 1 who are IFNa treatment naive.~   "
240837|NCT00402415|"~     There are two drugs involved in this study. Sunitinib (Sutent(R)) is approved by the Food and~     Drug Administration (FDA) for the treatment of advanced renal cell (kidney) cancer and~     gastrointestinal stromal tumors. Sunitinib is thought to work by blocking the growth of blood~     vessels into tumors; reducing the blood supply to tumors can slow their growth and sometimes~     causes the tumors to shrink. Sirolimus has been approved by the FDA to prevent the body from~     rejecting organ transplants. Sirolimus is being tested for its effects against cancer because~     it can slow the growth of some tumors in animal models. Sirolimus is thought to slow cancer~     growth in these animal models both by direct effects on the tumor cells, and also by blocking~     production of growth factors that stimulate production of blood vessels. We hope that the~     combined use of these two drugs will have better anti-cancer effects than either agent alone.~     This study is designed to find out if different doses of Sirolimus combined with a standard~     dose of Sutent are safe and well tolerated. Additionally, it is hoped to gain knowledge about~     the way that Sutent(R) in combination with sirolimus affects the blood vessels produced by~     cancer.~   "
240838|NCT00402402|"~     The purpose of the study is to estimate the usefulness of the QuantiFERON®-TB Gold test for~     the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating~     the test results with risk factors for LTBI~   "
240839|NCT00402389|"~     This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with~     perinatal depression.~   "
240877|NCT00401895|"~     Coated stents with different diameters are presently commercially available, but clinical~     studies on the assessment of the best stent diameter for a better clinical efficacy, a~     reduced number of complications, and an effective portal pressure reduction (essential in the~     treatment of those pathologies in which TIPS is indicated) still do not exist.~      Aim of the study The purpose of our study is to compare the clinical efficacy and the~     incidence of complications of TIPS created with 8- and 10-mm covered stents in patients with~     hepatic cirrhosis.~   "
240840|NCT00402376|"~     Cardiac function may improve in patients with end-stage heart failure who receive long-term~     support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be~     sufficient in some cases to allow explantation of the VAD. However, some questions continue~     to await definitive answers. This study is designed to assess the myocardial recovery under~     VAD support with optimal pharmacological therapy (high doses [group I] of statins,~     beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses [group II]).~      The study is a randomized, single-blind trial performed at the Department of Cardiac Surgery,~     University of Strasbourg, France. Twenty patients with end-stage heart failure who will be~     supported by VAD (Thoratec paracorporeal device) as a bridge to heart transplantation will be~     included. Reverse left ventricular remodeling and myocardial function will be studied by:~     echocardiography, respiratory mitochondrial function, exercise testing, cardiac hormonal~     function, and inflammatory response. Myocardial biopsies will be obtained at the time of VAD~     implantation and heart transplantation. The follow-up will be performed every 4 weeks during~     the VAD support period. The hypothesis of this trial is that reverse left ventricular~     remodeling and myocardial function will improve under optimal medical therapy especially by a~     high dose statin.~   "
240841|NCT00402363|"~     The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl~     esters) in patients with recurrent, symptomatic atrial fibrillation.~   "
240842|NCT00402350|"~     The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a~     single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a~     single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2~     is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl,~     evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial~     are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare~     the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability~     and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.~   "
240843|NCT00402337|"~     The primary purpose of this study is to evaluate the efficacy and safety of administration of~     linaclotide acetate in patients with chronic constipation.~   "
240844|NCT00402324|"~     Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of~     both mania and depression more than treatment with mood stabilizer alone, in patients with a~     mixed episode of bipolar I disorder.~   "
240845|NCT00402311|"~     The purpose of this study is to determine the effects and cost-effectiveness of a Diagnostic~     Observation Center for PsychoGeriatric patients (DOC-PG). Our main hypothesis is that DOC-PG~     has added value compared with usual care regarding Health Related Quality of Life (HRQoL).~   "
240846|NCT00402298|"~     This is a study of the safety and efficacy of MDMA-assisted psychotherapy in people with war~     or terrorism-related posttraumatic stress disorder (PTSD).~   "
240847|NCT00402285|"~     RATIONALE: The use of lycopene, a substance found in tomatoes, or omega-3 fatty acid~     nutritional supplements may keep cancer from growing in patients with prostate cancer.~      PURPOSE: This randomized clinical trial is studying lycopene to see how well it works~     compared to omega-3 fatty acids or a placebo in treating patients with stage I or stage II~     prostate cancer.~   "
240848|NCT00402272|"~     The purpose of this Clinical Evaluation is a continuation in the assessment of the~     performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in~     the treatment of patients with de novo coronary artery lesions.~   "
240849|NCT00402259|"~     The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole~     intravenous every 12 hours for 5 days in subjects with acute non-variceal upper~     gastrointestinal bleeding~   "
240850|NCT00402246|"~     The purpose of this study is to determine whether the ability of clinicians to receive and~     review information from patients implanted with a heart device over the internet (remote~     care) is comparable to patients who are seen in-office for routine visits to check the status~     of their device.~   "
240851|NCT00402233|"~     Primary objective: to assess the efficacy of pramipexole given two times daily compared to~     placebo.~      Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue,~     impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the~     tolerability among the treatment groups over 12 weeks~   "
240852|NCT00402220|"~     The main treatment option for Treatment Resistant Depression is electroconvulsive therapy~     (ECT) which is often effective but complicated by cognitive side effects, need for~     anaesthesia and considerable stigma.~      In recent years considerable efforts have been made to increase public awareness about~     depression and increase access to services. However, the increasing number of patients~     accessing treatment for depression in clinical services is also likely to be accompanied by a~     sizeable increase in the number of patients with TRD. Despite the demand, relatively few~     treatment options are available to such patients. One of the only substantially new~     treatments developed for TRD in recent years has been the advent of repetitive transcranial~     magnetic stimulation (rTMS). Repetitive TMS has been evaluated in over 20 trials conducted~     over the last 10 years. Previous research indicates that rTMS has antidepressant activity;~     however, the proportion of patients who respond to rTMS and the degree of treatment response~     demonstrated in trials to date is limited. The limitations of these studies include~     relatively small samples and limited duration of treatment (i.e., 2 weeks) as well as a lack~     of long term follow-up. As rTMS is gradually entering use in routine clinical practice (for~     example, recent regulation of its use in Canada), research is urgently required to establish~     ways to enhance treatment response both in regards to the extent of response within~     individuals and the proportion of individuals in whom rTMS has effects.~      Stimulation site is another important treatment factor; thus far almost all of the trials of~     rTMS in TRD conducted have evaluated the utility of high frequency left prefrontal cortex~     (PFC) rTMS (HFL-TMS). In addition, several studies have evaluated the treatment efficacy of~     low frequency rTMS to right PFC (LFR-TMS). In a previously published study we have~     demonstrated that these two approaches have similar therapeutic benefit and both were~     superior to sham stimulation.~      A promising new approach to enhance efficacy involves combining LFR-TMS and HFL-TMS in a~     sequential manner. We describe this as sequential bilateral rTMS (SB-rTMS). We have recently~     published the results of the first substantial evaluation of SB-rTMS showing not only a~     superiority to placebo in TRD but also a therapeutic response that is substantially superior~     to response rates in most of the published studies of unilateral rTMS (>50% of patients~     achieving standard criteria for clinical response compared to usually <30% in most studies).~     In this proposed research study, we will directly test the hypothesis that SB-rTMS produces a~     greater therapeutic response than HFL-TMS and compare both of these forms of stimulation to~     placebo (i.e., sham) stimulation.~   "
240894|NCT00401674|"~     The purpose of this study is to evaluate the toxicity and activity of weekly administration~     of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian~     cancer stage IC-IV.~   "
240996|NCT00400322|"~     The purpose of this study is to investigate if treatment of CMV infection by antiviral drug~     Valcyte (R) affects the clinical outcome of glioblastoma multiforme in patients with local~     CMV infection in tumor tissue. The investigators' hypothesis states that CMV infection~     promotes tumor development and disease progression and inhibits immune responses against the~     tumor.~   "
240853|NCT00402207|"~     Background Chronic inflammation in peripheral airways plays an important role in the~     pathophysiology of asthma. Extrafine hydrofluoroalkane (HFA) beclometasone is distinguished~     from other ICS because of its fine aerosol characteristics. As a result, there is a greater~     extent of deposition of extrafine HFA-beclometasone in the peripheral airways. Therefore,~     extrafine HFA-beclometasone may have an extra anti-inflammatory effect in children with~     asthma.~      Aim To analyse the potential extra anti-inflammatory effect of extrafine HFA-beclometasone~     compared to HFA-flucticasone in children with asthma by means of alveolar nitric oxide (NO)~     concentration and bronchial NO flux, inflammatory markers in exhaled breath condensate (EBC),~     and conventional parameters.~      Method In a cross-over study design of 6 months, 33 children, aged 6-12 years, with doctor~     diagnosed mild persistent asthma, were treated with extrafine HFA-beclometasone inhaled from~     an autohaler and HFA-flucticasone inhaled from a discus. Primary outcome parameters of this~     study were; alveolar NO concentration and bronchial NO flux. Secondary outcome parameters~     were inflammatory markers in EBC, lung function parameters, symptoms, presence and duration~     of exacerbations and adverse effects. All parameters were recorded at baseline and after each~     treatment period.~   "
240854|NCT00402194|"~     A study of 12 weeks' treatment with losartan or placebo, to test the hypothesis that RAS~     inhibition will improve insulin' vascular actions and therefore improve insulin sensitivity~     in skeletal muscle.~   "
240855|NCT00402181|"~     The purpose of this study is to evaluate the safety and efficacy of siltuximab in~     participants with relapsed (the return of a disease or the signs and symptoms of a disease~     after a period of improvement.) or refractory (cancer that does not respond to treatment)~     multiple myeloma (a type of cancer that begins in plasma cells [white blood cells that~     produce antibodies]).~   "
240856|NCT00402168|"~     The purpose of this study is to learn if conversion to belatacept from cyclosporine or~     tacrolimus will preserve kidney function in people who have had a kidney transplant. The~     safety and tolerability of this treatment will also be studied~   "
240857|NCT00402155|"~     Reading can be an uncomfortable and difficult task for some people. Symptoms include~     unpleasant somatic and perceptual effects, such as eye-strain, headache, and blurred text,~     despite normal visual acuity. This condition has been called Visual Discomfort, but little is~     known about the symptoms and frequency of reading problems associated with this disorder.~     Several studies have proposed that Visual Discomfort is caused by increased noise in the~     visual system due to spreading cortical activation across different spatial frequency~     channels. This study examines the prevalence and severity of visual discomfort in a college~     student population and tests the noisy visual system hypothesis.~   "
240858|NCT00402142|"~     1. To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid~          dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1~          infected patients in a very early stages of the disease (CD4 > 450 x 10 6 /L).~        2. To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based~          therapy.~   "
240859|NCT00402129|"~     To report the safety and efficacy of 1064nm low fluence laser hair reduction for the~     treatment of pseudofolliculitis barbae~   "
240860|NCT00402116|"~     There will be 2 phases in this study. Patients will either be enrolled to the first phase or~     to the second phase, depending upon when they enroll into the study.~      The first phase of this study is done to evaluate the safety of enzastaurin in patients. This~     is done by gradually increasing the dose of the drug in small groups of patients and watching~     closely for side effects.~      In the second phase of the study, the dose determined to be safe will be used with~     temozolomide during and following radiation therapy to see if the combination can help~     patients with brain tumors live longer.~   "
240861|NCT00402103|"~     To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg~     / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood~     Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).~   "
240862|NCT00402090|"~     TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described~     and are associated with a decrease activity of such enzyme. Therefore, a higher risk of~     developing toxicity is present in patients requiring these drugs, which are indicated in~     acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The~     frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations.~     Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of~     such polymorphisms in mestizos mexican population has not been analyzed, and we considered~     important to determine this frequency in healthy and patients requiring thiopurines,~     particularly acute lymphoblastic leukemia.~   "
240863|NCT00402077|"~     This study will examine the safety, tolerability, and body weight effect of subcutaneous~     pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or~     phentermine in overweight and obese subjects.~   "
240864|NCT00402064|"~     The use of bisphosphonates during childhood to ameliorate the skeletal abnormalities~     associated with osteogenesis imperfecta, idiopathic juvenile osteoporosis, fibrous dysplasia~     of bone and cerebral palsy. There is paucity of long-term studies among children regarding~     the safety and efficacy of bisphosphonates.~      Osteomyelitis and necrosis of the jaws has been was discovered and reported as a serious~     adverse event in bisphosphonate-treated adults patients.~      To our knowledge, there is no report in the literature about osteomyelitis in children~     treated with bisphosphonates and the influence of long term treatment with bisphosphonates on~     children's jaws, the reaction to extractions and on the oral cavity.~      Aim of the study: to examine the influence in the oral cavity of bisphosphonate in children~   "
240865|NCT00402051|"~     This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first~     line combination therapy with either cisplatin or carboplatin in the palliative setting of~     stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be~     included in about 15 centers in Germany and randomized to one of the above treatment regimens~     in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a~     standard length of 21 days. Primary objective will be the Progression Free Survival Time of~     patients as assessed in both treatment arms.~   "
240866|NCT00402038|"~     To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in~     patients with advanced medical illness.~   "
240869|NCT00401999|"~     This study will examine the relationship between variations in a gene called OPRM1 and the~     response to alcohol. The OPRM1 (Mu-opioid Receptor-1) gene helps regulate brain pathways~     involved in experiencing pleasure. Brain pathways use a chemical called dopamine. Different~     forms of the OPRM1 gene may lead to differences in how dopamine is released and subsequently~     to differences in a person's response to alcohol.~      Healthy non-smokers between 21 and 45 years of age may be eligible for this study. Candidates~     are screened with a medical and psychiatric history and physical examination, blood and urine~     tests, and breathalyzer (breath alcohol test). A blood test is also done to determine the~     variant of OPRM1 gene.~      Participants undergo the following procedures in three study sessions:~      Session 1~       Breathalyzer test, urine test for illicit drugs and pregnancy test for women who can become~     pregnant.~       Insertion of catheters (plastic tubes) into a vein in one arm for infusing alcohol and into~     the other arm for drawing blood samples.~       Completion of questionnaires on how intoxicated the subject feels.~       Blood draw for research studies.~       Eye movement test (a visor with a digital camera tracks the subject's eye movements while~     he or she watches lights on a computer screen).~       45-minute alcohol infusion (up to 0,08 grams per deciliter - a level considered in most~     states as driving under the influence of alcohol).~       Repeat breathalyzer, questionnaires, eye movement test and blood draw every 15 minutes~     during the infusion and again after the infusion is complete.~       Subjects remain in the clinic until their blood alcohol content falls below 0.02 g/dL,~     determined by a breathalyzer test done every 15 minutes. Subjects can usually return home~     about 3 to 4 hours after the alcohol infusion stops.~      Sessions 2 and 3~      The procedure is the same as for session 1, except subjects receive an infusion of alcohol~     one session and an infusion of saline (salt water) the other. Also, subjects undergo positron~     emission tomography (PET) scanning during the infusions. For this test, the subject lies on a~     bed that slides in and out of a doughnut-shaped scanner. A custom-molded mask is used to~     support the head and prevent it from moving during the scanning. A small amount of~     radioactive substance called C-11 raclopride is injected through one of the catheters to~     trace brain dopamine activity.~   "
240870|NCT00401986|"~     The primary purpose of this study is to gather additional safety data for the subjects~     treated with the Alair System (hereinafter, Alair-Treated Subjects) who previously~     completed the one-year study entitled: Multicenter Randomized Clinical Trial of Bronchial~     Thermoplasty with the Alair System for the Treatment of Severe Asthma (Protocol #0903-27)~     sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be~     followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year~     endpoint.~   "
240871|NCT00401973|"~     The goal of this study is to answer the following questions:~        -  Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the~          weight gain that is associated with olanzapine~        -  Whether taking amantadine, metformin or zonisamide can help patients decrease or~          eliminate some of the changes in body that occur with weight gain~        -  How weight gain associated with olanzapine can affect people~        -  Whether treatment with amantadine, metformin or zonisamide can help eliminate weight~          gain associated with olanzapine and not interfere with the positive effects of~          olanzapine on functioning of people with schizophrenia and other diseases~   "
240872|NCT00401960|"~     The aim of this study is to determine the safety and efficacy of daptomycin when used as an~     adjuvant agent to standard care in the treatment of proven native valve Enterococcal~     endocarditis. Patients with this disease will be offered the option of receiving daptomycin~     at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already~     receiving. The hypothesis of this study is that daptomycin added to standard therapy for~     Enterococcal endocarditis is safe and efficacious.~      Patients who receive daptomycin + standard therapy will be compared to patients who receive~     standard therapy alone with respect to the following outcomes:~        1. Safety.~             1. The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.~             2. The frequency of muscle toxicity or renal toxicity, as determined by predefined~               criteria.~        2. Efficacy.~             1. Clinical efficacy.~                  -  Time to clearance of bacteremia~                  -  Cure at 6 weeks following completion of antibiotic therapy~                  -  Mortality at 6 weeks following completion of antibiotic therapy~             2. Microbiologic efficacy.~                  -  Peak and trough serum bactericidal titers~                  -  The minimum bactericidal concentration of Enterococci to daptomycin~      We expect to enroll 40 patients over 2 years.~   "
240873|NCT00401947|"~     The purpose of this study is to Investigate the Safety, Tolerability, Pharmacokinetics and~     Antiviral Activity of Multiple Doses of ACH-0137171 in Subjects with Chronic Hepatitis C~     Infection~   "
240874|NCT00401934|"~     Cholera is a severe diarrhea illness caused by bacteria. The purpose of this study is to~     better understand how the immune systems of people in Dhaka, Bangladesh, fight infection with~     cholera. Understanding immune responses that influence the outcome of infection with cholera~     can assist in the development of more effective cholera vaccines. The International Center~     for Diarrheal Diseases Research, Bangladesh (ICDDR,B) will enroll in this study 75 patients~     with acute cholera and 250 of their household contacts. Individuals ages 2-60 years are~     eligible. Study participation will last 1 year for cholera patients and 30 days for household~     contacts. Participants will come to the ICDDR,B for 3 (household contacts) or 4 (cholera~     patients) study visits, and field workers will visit them at home at other times. For all~     participants, blood samples will be taken at each of the ICDDR,B visits. Household contacts~     will have rectal swabs taken at 2 ICDDR visits and during field worker visits.~   "
240875|NCT00401921|"~     The primary aim of this protocol is to investigate a possible new, neuroprotective treatment~     to prevent cognitive deficits that occur after carotid endarterectomy. We will investigate~     whether a widely used antibiotic agent - minocycline - that has shown neuroprotective effects~     in animal models of neurological diseases - can reduce the cognitive deficits associated with~     the surgical procedure of carotid endarterectomy (CEA). Because these cognitive deficits are~     believed to be a result of small strokes (due to emboli and/or hypoperfusion), this study~     will provide preliminary data on the use of this drug as a neuroprotective agent in stroke -~     a leading cause of disability.~      (1) The first aim of this study is to examine whether 5 doses of minocycline administered 36~     hrs before and 1 dose 12 hrs after the surgical procedure in patients undergoing CEA are~     effective to reduce the cognitive deficits associated with this procedure as compared with~     placebo.~      a. The null hypothesis is that there is no difference in cognitive performance changes after~     CEA between the patients that receive placebo or minocycline.~   "
240876|NCT00401908|"~     The rate of complication and death of patients with acute digestive tract bleeding is~     increased in the setting of acute coronary heart disease. The aim of the study is to~     establish the relative importance of the risk factors contributing to the death rate from~     acute digestive tract bleeding in patients admitted with acute coronary heart disease.~   "
240937|NCT00401115|"~     The purpose of this study is to determine the safety and tolerability of MS-R001 at~     escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy~   "
240878|NCT00401882|"~     The purpose of this research study is to evaluate the effectiveness of metoprolol, a beta~     blocker, in treating patients in the hospital with a cardiac arrest. It will be given~     intravenously (given into a vein). The subjects who will take part in this study are 18 years~     of age or older, are experiencing a cardiac arrest in the hospital, and are in a life~     threatening situation. Patients who develop a cardiac arrest require prompt electrical~     defibrillation (electrical shocks) to restore the normal beating rhythm of the heart. In~     patients who do not respond to electrical defibrillation, current standard of care recommends~     the use of medications which have been shown to be of unknown benefit. Some people recover~     from a cardiac arrest, but many people do not. We want to learn whether giving metoprolol~     will improve survival of patients with a cardiac arrest. A total of 100 patients will be~     enrolled in the study. Patients will receive either the standard of care with the drug~     epinephrine or the standard of care plus metoprolol.~   "
240879|NCT00401869|"~     The purpose of this study was to compare the effect of epoetin alfa to preoperative~     autologous blood donation (PAD) on postoperative vigor (a measure of functional ability and~     well-being) and handgrip strength in patients undergoing hip or knee surgery.~   "
240880|NCT00401856|"~     The aim of this study is to determine if therapy with the aldosterone antagonist, Eplerenone,~     is associated with improved remodeling of the left ventricle in patients with cardiomyopathy.~     We will determine if any benefit to cardiac remodeling is associated with improved clinical~     outcomes, including improved exercise capacity and reduced incidence of major adverse cardiac~     events such as death, hospitalization for heart-failure, serious heart rhythm disturbances~     and transplantation.~      The null hypothesis is that therapy with Eplerenone over 12 months is associated with an~     improvement in cardiopulmonary exercise capacity and furthermore that treatment is associated~     with improved clinical outcomes.~      In order to test this hypothesis we will study stable patients on optimal drug therapy with~     documented cardiomyopathy using a trial design where therapy will be randomized,~     double-blinded and placebo-controlled. This will reduce the likelihood of any 'researcher~     bias'. Patients will be recruited from the Heart-failure Service at the Royal Brompton~     Hospital.~   "
240881|NCT00401843|"~     The purpose of Part 1 of the study is to determine the safety of the combination of~     Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to~     compare the length of progression free survival for those patients given CNTO 328 and~     bortezomib to those patients given bortezomib alone.~   "
240882|NCT00401830|"~     This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to~     placebo in reducing the signs and symptoms of fibromyalgia syndrome.~   "
240883|NCT00401817|"~     Primary Objective~      1. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP~     (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).~      Secondary Objectives~        1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in~          patients with newly diagnosed MCL.~        2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP~          treatment.~   "
240884|NCT00401804|"~     The primary objective of the study is to evaluate the activity of BDD in subjects with acute~     renal failure as measured by· reversal of acute renal failureSecondary objectives· tumor~     response (complete and partial response)· To evaluate the safety of Bortezomib-~     Doxorubicin-Dexamethasone in this patient population· to evaluate the activity of Bortezomib-~     Doxorubicin -Dexamethasone on progression free survival · to evaluate the activity of~     Bortezomib- Doxorubicin -Dexamethasone on overall survival~   "
240885|NCT00401791|"~     The study is designed to compare muscle energy capacity in men with obesity or diabetes as~     compared to athletes. This study will also enable researchers to determine whether MRS can~     replace muscle biopsy for this type of assessment.~   "
240886|NCT00401778|"~     This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer~     will be treated with RAD001 to evaluate the target effects of this compounds on relevant~     molecular pathways and on the 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) uptake~     of the tumor by a positron emission tomography (PET) scan at baseline and immediately prior~     to surgery. The safety profile of RAD001 will also be evaluated.~   "
240887|NCT00401765|"~     The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given~     together as a treatment. The second goal of this study is to determine if a combination of~     docetaxel and CNTO 328 has an effect on prostate cancer.~   "
240888|NCT00401752|"~     The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily~     and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of~     gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug~     (NSAID)therapy.~   "
240889|NCT00401739|"~     Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by~     uncontrolled proliferation of the myeloid line of white blood cells and impaired production~     of normal blood cells. If untreated, patients die of infection or bleeding usually in a~     matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the~     cells that are thought to drive AML but that are not effectively killed by standard~     treatment. The aims of the study are to determine a biologically active dose of CSL360 and~     generate understanding of a rational schedule of administration for future studies.~   "
240890|NCT00401726|"~     The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in~     subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a~     patient management program, which aims to help patients achieve successful outcomes by~     reinforcing physician treatment efforts, providing feedback to treating physicians, and~     encouraging better physician-patient communications.~   "
240891|NCT00401713|"~     The purpose of this study is to evaluate two surgical interventions in patients with AMD.~   "
240892|NCT00401700|"~     The purpose of this trial is to assess the knowledge and attitudes of post-partum women~     regarding influenza and the use of the influenza vaccine in pregnancy.~   "
240893|NCT00401687|"~     The purpose of this clinical research study is to demonstrate the ability of Definity®~     enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of~     left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).~   "
240991|NCT00400387|"~     With this clinical trial the investigators will analyze whether the rate of pregnancy losses~     before the 24th week of gestation can be reduced by dalteparin treatment in habitual~     aborters.~   "
240895|NCT00401661|"~     Primary objective:~        -  End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation~          domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign~          prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.~      Secondary objectives:~        -  MSHQ-EjD improvement by visit~        -  Improvement in International Prostate Symptom Score (IPSS) total score, voiding and~          filling subscores, nocturia and bother score at end-point and by visit~        -  Onset of action of XATRAL 10mg OD~        -  Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.~   "
240896|NCT00401648|"~     to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive~     epileptic subjects~   "
240897|NCT00401635|"~     The purpose of this study is to evaluate activity and toxicity of the combination of~     carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or~     recurrent endometrial carcinoma.~   "
240898|NCT00401622|"~     To assess the clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52~     weeks of use.~   "
240899|NCT00401609|"~     The purpose of this study is to describe the activity and toxicity of gemcitabine combined~     with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first~     line treatment of elderly patients with extensive small cell lung cancer.~   "
240900|NCT00401596|"~     This was a multicenter, open label, randomized, controlled, safety trial in subjects aged~     6-75 years with a diagnosis of moderate to severe, persistent asthma. A total of 1899~     subjects were randomized (2:1) to either the active treatment group or the control group.~     Upon successful completion of the screening period (~2 weeks), each subject entered the 24~     week study.~   "
240901|NCT00401583|"~     This is a Phase I study to determine the effect of GW786034 (pazopanib) on P450 enzymes. This~     study will help determine which types of drugs may interact with GW786034.~   "
240902|NCT00401570|"~     This clinical trial is being conducted to determine tumor response and preliminary safety of~     a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that~     is required for the establishment of new blood vessels during tumor growth, a process known~     as angiogenesis.~   "
240903|NCT00401557|"~     The purpose of this study is to determine how the body defends itself against Leishmania~     (Viannia), a parasite that can cause a skin infection and skin sores. Certain cells in the~     immune system act more aggressively against Leishmania in people with mild Leishmania~     symptoms than in those who have long-term or recurring symptoms of the disease. Participants~     in the study will include people who currently have Leishmania infection, people who have had~     the infection in the past, and people who have never been exposed to the parasite. This study~     will enroll 220 adults, ages 18 to 70 years, at 3 sites in Colombia. Blood samples will be~     collected from volunteers at least once during the study. Participants will also undergo HIV~     testing. Volunteers will participate in up to 2 study visits, scheduled 2-3 weeks apart.~   "
240904|NCT00401544|"~     To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously~     (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron~     supplementation in the treatment of anemia in patients with non-myeloid malignancies who were~     receiving multicycle chemotherapy.~   "
240905|NCT00401531|"~     The purpose of the study is to provide immunogenicity and safety data of the investigational~     hexavalent vaccine when it is given concomitantly (the same day at separate injection sites)~     with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB~     vaccine at birth.~      Primary Objective:~      To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune~     response that is at least as good as the response following Infanrix™-Hexa in terms of~     seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6~     months), when co-administered with Prevnar®~      Secondary Objectives:~      Immunogenicity:~      To describe in each group the immunogenicity parameters to each vaccine component (for~     DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.~      Safety:~      To describe the overall safety after each injection.~   "
240906|NCT00401518|"~     The purpose of this study is to determine if the ACADIA® Facet Replacement System is~     effective in the treatment of spinal stenosis. The primary objective of the study is to~     evaluate the overall success rate of the Anatomic Facet Replacement System in patients with~     spinal stenosis when compared to a posterior spinal fusion control.~   "
240907|NCT00401505|"~     The purpose of this study is to determine the reasons why multiparous women (women who are~     pregnant and have been pregnant before) might still be susceptible to rubella.~   "
240908|NCT00401492|"~     The main purpose of this study is to describe activity and toxicity of single-agent~     gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin~     (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients~     with advanced non small cell lung cancer~   "
240909|NCT00401479|"~     This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, retards the~     emptying of the colon and increases total colonic transit time.~   "
240910|NCT00401466|"~     The completed MADIT II study has shown that implantation of a cardioverter-defibrillator~     (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial~     infarction reduces death from any cause. The probability of the first therapy due to~     ventricular tachyarrhythmia was about 34% within 3 years. With a 3-month ICD-follow-up~     scheme, as it is in the standard ICD therapy, the majority of patients is followed more~     closely than necessary with respect to anti-tachyarrhythmia ICD therapy.~      A Home Monitoring (HM) function has been integrated into several ICD models from Biotronik~     (Berlin , Germany), for close remote monitoring of ICD patients. The HM function may~     substitute in-clinic follow-up controls.~      The objective of our study is to compare a standard 3-month follow-up scheme and a 12-month~     follow-up scheme using HM in ICD recipients with the MADIT II indications. The comparison~     should be made with respect to the difference in follow-up burden and the associated costs,~     and regarding possible impact of the remote follow-up via HM on all cause mortality,~     hospitalization, and patients' quality of life.~   "
240992|NCT00400374|"~     This is a phase I study of second primary tumor prevention in early stage (stage I/II)~     patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).~   "
240911|NCT00401453|"~     Insulin resistance is a central feature of Diabetes mellitus type 2 (Stumvoll et al. 2005).~     Hypo- and hyperglycemic states are associated with adverse inpatient outcomes (ADA et al.~     2006 Diab Care) and with the development of microvascular complications (UKPDS 34 Lancet~     1998).~      A long known therapy for the acute treatment of patients with deteriorated glucose metabolism~     and insulin resistance are carbohydrate days. The principle of the therapy was firstly~     introduced in 1903 by Carl von Noorden (Noorden et al. 1903). The diabetic patients were~     treated for several days with a carbohydrate rich diet with fat restriction. Surprisingly,~     this resulted in an amelioration of glucosuria. Today it's still a valuable tool for patients~     with uncontrollable diabetes mellitus and severe insulin resistance (Willms B. 1989). But up~     to now there has been no systemic evaluation of carbohydrate days in patients with~     deteriorated Diabetes mellitus and insulin resistance.~      The investigators conducted a pilot study with 14 patients to evaluate the efficacy of two~     days of oatmeal on insulin resistance and glucose metabolism in an acute clinical setting and~     after a four week outpatient period. Inclusion criteria were type 2 diabetes with~     deteriorated glucose metabolism, insulin resistance defined as an insulin dosage of more than~     1 U per day and kg bodyweight. Within this pilot trial the investigators found a marked~     decrease of insulin requirements (~40%) and mean daily blood glucose to a mean blood glucose~     of 114.7±36.7 mg/dl in the acute setting as well as after the four week outpatient period~     (Lammert et al. 2006).~      The most important shortcomings of this study were the hypocaloric interventions in both~     groups (diabetes-adapted diet: 1500kcal/d vs. oatmeal 1200kcal/d) making it difficult to~     attribute the observed effects to oatmeal alone as well as the uncontrolled nature. These~     design flaws have been addressed within this new clinical trial. The investigators plan an~     open label, cross-over study with isocaloric interventions (oatmeal and diabetes-adapted~     diet: ~ 1200kcal/d). The intervention comprises two days of oatmeal (third and fourth day)~     within a 5 day hospital stay. The control is only treated with 5 days of diabetes adapted~     diet. Thereafter, the patients are followed every four weeks for an overall of 16 weeks.~   "
240912|NCT00401440|"~     The hypothesis of the study is that the induction abortion interval time will be~     significantly shorter in the group receiving vaginal misoprostol every six hours in~     comparison to the group who are receiving vaginal misoprostol every twelve hours.~   "
240913|NCT00401427|"~     The combination of vinorelbine with weekly trastuzumab has produced high response rate in~     HER2 overexpressing metastatic breast cancer (MBC). The present phase 2 study was planned to~     test activity of the same combination, with trastuzumab given every 3 weeks, rather than~     weekly.~   "
240914|NCT00401414|"~     In this research study, the investigators are trying to find a better way to set the dose of~     a common blood-thinning medication.~      Patients with blood clots or a risk of blood clots (or stroke) sometimes have to take an~     approved medication called warfarin. Warfarin is a commonly prescribed, approved blood~     thinning medicine taken by mouth. There is a certain level of warfarin that is best for each~     patient at a particular time. It is hard for a doctor to choose and maintain the right dose~     of warfarin for each patient. Too much or too little warfarin in the blood can cause serious~     health problems.~      A nomogram is a tool that helps doctors decide on the right dose of warfarin. The usual way~     for finding the right dose of warfarin is for doctors to take an educated guess and use a~     trial and error approach. Patients have frequent blood tests to help doctors keep track of~     how well the dose level is working.~      Up until now, if a patient had good blood test results over half of the time, that was as~     well as doctors could do. The purpose of this study is to see whether the investigators can~     create a reliable new warfarin nomogram that will allow them to dose a patient correctly more~     often, perhaps about 3 times out of 4. The nomogram the investigators are studying uses~     information about a patient's health and genes to decide on the best dose of warfarin.~      The investigators don't yet have a reliable, safe way to choose the correct dose. In this~     study, the investigators will use a genetic blood test to try to find a better way. Genes are~     the parts of each living cell that allow characteristics to be passed on from parents to~     children. The investigators know that people with certain genes seem to respond to warfarin~     in a certain way. From a blood sample, the investigators can look at patients' genes and try~     to predict the response to the blood-thinning medication.~      There will be about 500 subjects taking part in this study. They will come from participating~     Partners' Hospitals, including Brigham and Women's Hospital, Massachusetts General Hospital,~     Faulkner Hospital, Newton-Wellesley Hospital, Spaulding Rehabilitation Hospital, and North~     Shore Medical Center. The U.S. Food and Drug Administration (FDA) has approved warfarin for~     use as a blood thinner.~   "
240915|NCT00401401|"~     The purpose of this study is to investigate the safety of zalutumumab in combination with~     chemotherapy and radiotherapy as treatment of patients with head and neck cancer~   "
240916|NCT00401388|"~     This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part~     sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg~     orally qhs with food until disease progression. The goals of this study include:~        -  In this study a daily dose of perifosine previously determined to be relatively~          non-toxic will be evaluated in patients with chondrosarcomas, alveolar soft part~          sarcomas and extra-skeletal myxoid chondrosarcomas.~        -  Response to therapy will be based on regression of measurable disease according to Choi~          criteria. Time to progression and duration of stable disease will be measured as~          secondary endpoints of the study.~   "
240917|NCT00401375|"~     To evaluate the safety and efficacy of MNTX in patients who have undergone segmental~     colectomy and to assess if the time between the end of surgery and the first bowel movement~     is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo~     regimen.~   "
240918|NCT00401362|"~     To test the effectiveness of MNTX in advanced illness subjects.~   "
240919|NCT00401349|"~     CIDEIM, Centro Internacional de Entrenamiento e Investigaciones Medicas, is conducting a~     research study about the disease Cutaneous Leishmaniasis, which is caused by the Leishmania~     parasite and causes skin sores. Researchers hope to find out how the human body defends~     against Leishmania. A total of 472 individuals, ages 7 to 70 years, belonging to one of the~     following groups will be included in this study: recurring disease, chronic disease, disease~     with no sign or symptoms (asymptomatic), and healthy individuals. Study procedures will~     include a questionnaire and buccal swab (swabbing of the inside of the cheek with a cotton or~     wooden applicator). In addition, asymptomatic and healthy individuals will provide a blood~     sample. Study participation will be up to 1.5 hours.~   "
240920|NCT00401336|"~     Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to~     many disorders. Assessment of body iron stores by measurement of serum ferritin~     concentrations has poor specificity and the most reliable method is histological or~     biochemical assessment from a liver biopsy. Because liver biopsy is an invasive procedure,~     imaging methods have been developed to detect and quantify hepatic iron content. The aim of~     the study is to use a simplified magnetic resonance imaging (MRI) technique to quantify~     simultaneously iron and fat contents in the liver and to compare the results to the~     quantification obtained biochemically.~   "
240921|NCT00401323|"~     The purpose of the study is to compare time to progression and overall survival after~     treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the~     first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of~     the head and neck.~   "
240922|NCT00401310|"~     The safety and efficacy of MK0724 will be assessed in patients with acute middle cerebral~     artery stroke using the Action Reach Arm Test (ARAT). This test allows measurement of a~     specific functional deficit and subsequent recovery correlating with the specific area of~     stroke in the brain.~   "
241012|NCT00400114|"~     The purpose of this study is to see whether or not the combination of cisplatin, irinotecan~     and radiation, followed by surgery, followed by oral Sutent, is effective and safe for~     patients with resectable esophageal cancer.~   "
240923|NCT00401297|"~     The purpose of this study is to determine what types of cells participate in the defense of~     humans against Leishmania (skin parasites). People 18-70 years of age who have leishmaniasis,~     have healed leishmanial lesions, or are healthy are being invited to participate in this~     study. Approximately 150 people will participate in the study. Participants will be asked to~     provide some general information about themselves and about skin sores, if they have any. A~     skin test will be performed and a blood sample will be obtained. This study involves up to 3~     visits; the first visit will last up to 5 hours and the second visit will last for 30~     minutes. The third visit may be scheduled within 3 days after the second visit.~   "
240924|NCT00401284|"~     The purpose of this study is to determine whether a compound known as EVT 201 is effective in~     treating elderly patients diagnosed with primary insomnia who also have moderate daytime~     sleepiness.~   "
240925|NCT00401271|"~     The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg,~     200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days,~     in patients with uncomplicated, smear-positive pulmonary TB.~      The four OPC-67683 treatment groups will comprise 12 patients each and the one standard~     therapy (Rifafour e-275) group six patients.~      Trial 242-06-101 is an exploratory and not a confirmatory trial and as such no hypothesis~     will be tested statistically.~      The control group, six patients treated with Rifafour, will serve as an control to confirm~     the microbiological assessments during the trial.~   "
240926|NCT00401258|"~     We hypothesize that duloxetine treatment will be associated with improvement in symptoms of~     IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder.~      During this 12-week, open-label, outpatient study, male and female subjects between the ages~     of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be~     treated with open-label duloxetine.~   "
240927|NCT00401245|"~     Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor~     (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated~     with menopause. Nausea is the most common adverse event that is observed in clinical studies~     and is the main reason for discontinuation during the first week of therapy. Other adverse~     events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when~     subjects abruptly discontinue the medication. The purpose of this study is to evaluate~     several titration and tapering regimens of DVS SR to ensure a better tolerability profile at~     the start and completion of treatment. In addition, this study will provide a long~     posttreatment follow-up to assess any symptoms after treatment is discontinued.~   "
240928|NCT00401232|"~     This is a study to collect blood from volunteers to assist in assay development.~   "
240929|NCT00401219|"~     This study will compare the bioavailabity of three new investigational combination~     formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed~     formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in~     women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe~     dryness, itching, and burning, in and around the vagina; and to help reduce your chances of~     getting osteoporosis (thin weak bones). The purpose of this study is to determine if these~     new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as~     Prempro in healthy postmenopausal women.~   "
240930|NCT00401206|"~     To determine safety and effectiveness of dexmedetomidine when administered for conscious~     sedation during flexible bronchoscopy (FB) in patients with Chronic Obstructive pulmonary~     Disease (COPD).~   "
240931|NCT00401193|"~     The purpose of this study is to determine whether XP12B is effective and safe in the~     treatment of women with heavy menstrual bleeding associated with menorrhagia.~   "
240932|NCT00401180|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and temozolomide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel and~     temozolomide in treating patients with metastatic cancer.~   "
240933|NCT00401167|"~     Alzheimer's disease (AD) is the most common form of dementia and is characterized by both~     cognitive and behavioural symptoms (Behavioural and Psychological Symptoms of Dementia;~     BPSD). To date, there are only modestly effective treatments for BPSD, and these treatments~     are associated with an increased risk of mortality in elderly dementia patients. We plan to~     study whether treatment with medication memantine improves BPSD in severe AD patients.~     Thirty-two AD patients with significant BPSD, including agitation and aggression, will be~     treated for three months with memantine. Assessments of behavioural symptoms and global~     clinical outcomes will be completed after one, two and three months of treatment.~   "
240934|NCT00401154|"~     The study is about the effect of an exercise program using stationary bicycling for children~     with the spastic diplegic form of cerebral palsy. Spastic diplegia is a type of cerebral~     palsy that involves spasticity or tightness of the leg muscles. We hope to learn whether~     this type of exercise will allow the children to develop improved strength in the muscles~     that bend and straighten their knees, enhance their level of physical fitness, improve their~     ability to walk and improve their ability to perform other activities that are important to~     them. We hypothesize that children who participate in the stationary cycling intervention~     will gain strength in the muscles that bend and straighten their knees, will be able to~     complete a 600 yard walk run test (a test of endurance) more rapidly, and will improve their~     score on a test of function called the Gross Motor Function Measure (a test designed~     specifically for children with cerebral palsy).~   "
240935|NCT00401141|"~     Previous experimental data strongly suggest that B lymphocytes have intrinsic abnormalities~     during lupus in mice spontaneously affected by the disease. This study tries to define these~     abnormalities by looking at the gene expression profile of purified B lymphocytes from~     patients with non active systemic lupus , compared with the gene expression profile of~     purified B lymphocytes from healthy donnors.~   "
240936|NCT00401128|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine~     together with irinotecan works in treating patients with metastatic kidney cancer.~   "
240938|NCT00401102|"~     The purpose of this study is to examine the feasibility of using Interpersonal Psychotherapy~     for Depressed Adolescents (IPT-A) to treat adolescents who are experiencing symptoms of~     depression and are engaging in non-suicidal self-injurious behaviors. The trial will include~     recruiting 10 particpants, administering 12-sessions of individual IPT-A, and determining how~     the IPT-A protocol needs to be amended to adequately address the self-injury in addition to~     depression.~   "
240939|NCT00401089|"~     The objective of the study is to determine whether Panax Ginseng with multiple interactions~     with key components of brain signaling pathway, can augment the effects of antipsychotics in~     Schizophrenia. We are primarily interested to examine the actions of Ginseng combined with~     antipsychotics in improving the ways patients diagnosed with schizophrenia behave in social~     environment, store, process and retrieve information.~   "
240940|NCT00401076|"~     This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or~     decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for~     52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in~     the non-compensatory stage or by pancreatectomy.~   "
240941|NCT00401063|"~     The purpose of this study is to assess the effects of acupuncture on aspects of health~     including pain, energy level, sleep quality, activities of daily living and appetite.~   "
240942|NCT00401050|"~     The purpose of this study is to compare outcomes of combined chiropractic care in anterior~     knee pain patients with patellofemoral pain syndrome.~   "
240943|NCT00401024|"~     RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in~     the laboratory may help doctors learn how patients respond to treatment.~      PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving~     imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the~     tumor tissue.~   "
240944|NCT00401011|"~     This is a phase I/II study of perifosine in combination with bortezomib—with or without~     dexamethasone—for patients with relapsed or refractory multiple myeloma previously treated~     with bortezomib. The current protocol will enroll patients with relapsed or refractory~     multiple myeloma who have been previously treated with bortezomib. The patients will be~     treated with perifosine, 50 mg or 100 mg qhs, in combination with bortezomib to determine if~     there is any preliminary evidence that the addition of perifosine improves the outcome for~     these patients. Previous treatment with perifosine will be allowed in this study. Patients~     progressing on treatment with perifosine and bortezomib will receive dexamethasone 20 mg on~     days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 18, and 19 of each 21-day cycle in addition to~     bortezomib and perifosine.~   "
240945|NCT00400998|"~     The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in~     and out of season, and Park Study in season and the clinical efficacy of repeat doses of~     fluticasone propionate in subjects with seasonal allergic rhinitis.~   "
240946|NCT00400985|"~     The SENSE-HF study is a prospective, observational, international multi-center study~     prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid~     Trends data in predicting HF-related hospitalizations and health care utilizations associated~     with signs and/or symptoms of pulmonary congestion, and to define OptiVol clinical guidelines~     for subject therapy management.~   "
240947|NCT00400972|"~     The purpose of this study is to determine whether nasal intubation assisted by GlideScope~     videolaryngoscopy is faster, easier, and less traumatic than nasal intubation with~     conventional direct laryngoscopy.~   "
240948|NCT00400959|"~     TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial~     infarction.~      TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.~      SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction~     (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty~     (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB)~     grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al.,~     Circulation, 2002).~      OBJECTIVES Primary:~        1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone~          marrow (ABM) and mobilized peripheral blood (MPB) in the target population.~        2. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in~          the culprit vessel of the target population, on regional and global contractile function~          and on perfusion and metabolism of the infarcted area, depending on cell dose and~          comparing to controls.~           Secondary:~        3. To evaluate the disease-related morbility of the target population.~   "
240949|NCT00400946|"~     RATIONALE: L-asparaginase is an important component of treatment for childhood acute~     lymphoblastic leukemia, but is also associated with notable side-effects, including~     hypersensitivity, pancreatitis, and thrombosis. We have previously reported that patients~     with acute lymphoblastic leukemia in whom asparaginase treatment was discontinued because of~     intolerable side-effects had survival outcomes that were inferior to those who received all~     or nearly all of their intended doses. Two bacterial sources of asparaginase exist:~     Escherichia coli (E coli) and Erwinia chrysanthemia (Erwinia). Generally, the E coli-derived~     enzyme has been used as front-line therapy and the Erwinia-derived preparation has been~     reserved for patients who develop hypersensitivity reactions. Pegylated E coli asparaginase~     (PEG-asparaginase) has a longer half-life and is potentially less immunogenic than native E~     coli L-asparaginase, and has been used as the initial asparaginase preparation in some~     pediatric acute lymphoblastic leukemia treatment regimens.~      PURPOSE: Although the pharmacokinetics of each of these asparaginase preparations:~     intravenous PEG-asparaginase (IV-PEG) and intramuscular native E coli L-asparaginase (IM-EC)~     have been well characterized, their relative efficacy and toxicity have not been studied~     extensively.~   "
240950|NCT00400933|"~     The aim of this project is to analyze the impact of a psycho-educational group program on the~     family members and close friends of persons with eating disorders and co-morbid personality~     disorders.~   "
240951|NCT00400907|"~     RATIONALE: Treatment for diffuse large B-cell non-Hodgkin's lymphoma may cause side effects~     and secondary cancers later in life. An observational study that evaluates patients after~     undergoing six courses of combination chemotherapy with or without rituximab and radiation~     therapy may help doctors predict a patient's response to this treatment and help plan the~     best treatment.~      PURPOSE: This observational study is evaluating patients with diffuse large B-cell~     non-Hodgkin's lymphoma to see how well treatment on clinical trial CAN-NCIC-LY9 works.~   "
240952|NCT00400894|"~     Emerging from a differential proteomic study of sample pairs of prostate cancer and benign~     tissue, annexin A3 (ANXA3) was chosen as a potential novel biomarker for the early and~     non-invasive diagnosis of prostate cancer. We wanted to show or investigate, that:~        -  ANXA3 can be detected in urine after standard digital rectal examination.~        -  ANXA3 has better specificities than tPSA, in particular in the grey zone of PSA~        -  ANXA3 can help avoid unnecessary biopsies~        -  ANXA3 can in the long run replace PSA as a marker~   "
240953|NCT00400881|"~     To compare a new mode of mechanical ventilation, Automatic Tube Compensation (ATC) with a~     traditional one, Continuous Positive Airway Pressure(CPAP), on its effectiveness for~     detecting patients no longer needing mechanical ventilation.~   "
240954|NCT00400868|"~     The purpose of the study is to compare the short- and long-term effectiveness of an~     individualized, resource-oriented joint protection intervention with the standard,~     problem-oriented joint protection intervention for patients with rheumatoid arthritis.~   "
240955|NCT00400855|"~     Inhaling AMP causes an inflammatory response in the lung. This study will investigate whether~     5-days of treatment with fluticasone propionate protects the lung from responding to the AMP~     in this way.~   "
240956|NCT00400842|"~     This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic~     exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by~     pancreatectomy as compared with placebo under a double-blind design using the change in a~     coefficient of fat absorption as a primary endpoint.~   "
240957|NCT00400829|"~     This phase II trial is studying how well E7389 works in treating patients with recurrent or~     progressive stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy,~     such as E7389, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing.~   "
240958|NCT00400816|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients~     with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.~   "
240959|NCT00400803|"~     The purpose of this study is to determine whether treatment with carboplatin and gemcitabine~     combined with bevacizumab every two weeks will provide increased survival.~   "
240960|NCT00400790|"~     Background: Different anaesthetic agents have been shown to have different protective effects~     upon heart, brain and renal function under ischaemic conditions (oxygen starvation).~     Cardiopulmonary bypass takes over the work of the heart and the lungs during heart surgery,~     but oxygenation of vital organs such as the brain and heart may not be perfect, and can~     produce brain or heart damage as a consequence. Propofol and desflurane are commonly used~     anaesthetic agents, and there has been recent research to suggest that anaesthetic agents may~     provide some protection during periods where inadequate oxygenation occurs, with the~     potential to reduce the degree of organ damage. Both types of anaesthetics are used for~     cardiac surgery with anaesthetists choosing between them largely on the basis of personal~     preference.~      Aim: To determine whether the use of either propofol or desflurane as the primary anaesthetic~     agent, can lead to differences in postoperative brain function, total morbidity or cost,~     following coronary artery surgery with cardiopulmonary bypass.~      Methods: Patients will be recruited by professional research staff and will be randomised~     into one of two groups (90 in each group). They will receive a standardized technique for~     anaesthesia, cardiopulmonary bypass and postoperative ICU treatment. The only difference~     between the 2 groups will be as to which anaesthetic agent they receive during the surgical~     period, desflurane or propofol. Measurements will involve i) brain function testing before~     and 3 months after surgery ( a set of 10 verbal or manual tests), ii) incidence of delirium~     in the immediate postoperative period (a survey form), iii) incidence of total postoperative~     morbidity and iv) cost of hospital stay. Data collection will be by anaesthesia and research~     staff and a neuropsychologist will employed for performing the brain function testing.~      Anticipated timeline: Initial recruitment completed by 15-18 months following trial~     commencement. Follow up completed 3 month after the last enrolment. Data validation,~     statistical analysis and manuscript preparation completed by 24 months.~   "
240961|NCT00400777|"~     This study is designed to evaluate the efficacy and safety of the combination valsartan with~     hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan~     with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken~     comparing two different possible ways to achieve the higher dosage of the triple combination,~     i.e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.~   "
240962|NCT00400764|"~     This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety,~     pharmacokinetics, and efficacy of dulanermin when combined with rituximab in subjects with~     follicular, CD20+, B-cell Non-Hodgkin's Lymphoma (NHL) that has progressed following a~     response of ≥ 6 months duration to a prior rituximab-containing therapy. The multicenter,~     international, randomized Phase II part of this study will commence only after the safety and~     available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the~     Sponsor and have been provided to participating investigators and the FDA.~   "
240963|NCT00400751|"~     Although spousal support predicts the success of a smoker's cessation efforts, social~     support interventions based on teaching partners better support skills have had consistently~     disappointing results. We examined the potential utility of a family-consultation (FAMCON)~     intervention based on family-systems theory in a treatment-development project involving 20~     couples in which one partner (the primary smoker) continued to smoke despite having or being~     at significant risk for heart or lung disease. Results were promising. The 50% rate of stable~     abstinence achieved by primary smokers over at least 6 months exceeds benchmark success rates~     reported in the literature for other, comparably intensive interventions, suggesting that a~     couple-focused intervention different in concept and format from social-support interventions~     tested in the past may hold promise for health-compromised smokers. The FAMCON approach~     appeared particularly well-suited to female smokers and smokers whose partner also smoked –~     two sub-groups at high risk for relapse.~   "
240964|NCT00400738|"~     Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have~     shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen.~     This study will explore this idea.~   "
240965|NCT00400725|"~     The objective of the study is to assess the maintenance effect on scalp psoriasis of Clobex®~     Shampoo 0.05% when used twice weekly.~   "
241013|NCT00400101|"~     Influenza virosomes represent an innovative human-compatible antigen delivery system that has~     already proven its suitability for subunit vaccine design. The aim of the study was to proof~     the concept that virosomes can also be used to elicit high titers of antibodies against~     synthetic peptides derived from the circumsporozoite protein and from the~     apical-membrane-antigen 1 and that the formulations are safe in humans.~   "
240966|NCT00400712|"~     Once discharged from hospital many stroke survivors deteriorate medically, physically and in~     their mobility function and many report their level of function and quality of life to be~     poor 12 months after inpatient rehabilitation. There is an identified need for follow-up~     examinations of community dwelling stroke survivors to monitor changes in function and it has~     been suggested that maintenance therapy could curtail declines in function. The purpose of~     this trial is to determine whether brief periods of intense client-centered rehabilitation~     therapy (tune-ups) provided at 6 month intervals can alter the natural progression of~     impairment (physical capacity), function and community reintegration following stroke.~   "
240967|NCT00400699|"~     RATIONALE: An outreach program may help minority or low-income cancer patients overcome~     problems that keep them from receiving quality care.~      PURPOSE: This clinical trial is studying how well a radiation therapy outreach program works~     in minority or low-income patients with newly diagnosed cancer.~   "
240968|NCT00400686|"~     RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat~     anemia in patients with multiple myeloma.~      PURPOSE: This clinical trial is studying how well epoetin alfa works in treating anemia in~     patients undergoing chemotherapy for multiple myeloma.~   "
240969|NCT00400673|"~     The study was set up to assess:~        1. A two-step, increasing-intensity remission induction phase. A conventional chemotherapy~          course (ICE, plus G-CSF) was followed, in unresponsive patients, by sequential high-dose~          cytarabine (plus G-CSF), aiming to provide an early effective rescue to as many~          refractory cases as possible.~        2. A risk-oriented postremission consolidation phase. The objective was to adopt allogeneic~          stem cell transplantation (alloSCT) in high-risk (HR) cases, while standard-risk (SR)~          ones were consolidated with a multicycle high-dose cytarabine-containing program, which~          included the use of autologous stem cells plus G-CSF to limit drug-related toxicity and~          intercycle treatment delays.~   "
240970|NCT00400660|"~     GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's~     future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more~     stable drug suspension, this in turn will produce a consistent dose of drug being delivered~     with each puff.~   "
240971|NCT00400647|"~     This study will assess the quality of life in renal transplant recipients who require a~     reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and~     will also access the relationship between mycophenolic acid (MPA) dose in those patients~     receiving enteric-coated mycophenolate sodium formulation(EC-MPS).~      Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then~     again at 12 weeks post-conversion.~   "
240972|NCT00400634|"~     The purpose of this double blind study is to determine whether CERE-120 (adeno-associated~     virus serotype 2 [AAV2]-neurturin [NTN]) is effective and safe in the treatment of patients~     with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic~     injections targeting the putaminal region of the brain. The design of this study involves~     approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and~     approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).~   "
240973|NCT00400621|"~     The study objective was to evaluate the safety of ten consecutive days of therapeutic~     acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury~     (measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to~     10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11~     to look for injury. We hypothesized that there would be no difference in liver enzymes~     between the two groups.~   "
240974|NCT00400608|"~     Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA~   "
240975|NCT00400595|"~     Peritoneal dialysis (PD) is used for the treatment of end-stage renal disease in~     approximately 25% of patients requiring dialysis in Canada. The most common complication is~     bacterial infection or 'peritonitis'. Peritonitis causes severe acute abdominal pain and may~     lead to failure of peritoneal dialysis treatment, hospitalization or death, particularly if~     left untreated. Amongst the strategies used to prevent peritonitis, patients are instructed~     on the regular use of a prophylactic ointment around the point where the catheter exits from~     the body. At the present time most centers in Canada routinely prescribe mupirocin ointment~     for use at the exit site, however newer ointments have become available. One such ointment is~     Polysporin Triple. The aim of this study is to determine if catheter related infections can~     be significantly reduced by the routine application of Polysporin Triple in comparison to~     mupirocin ointment. A multi-centre, randomized, double blind, controlled study is proposed.~     Participants will be randomized to either mupirocin or Polysporin Triple and followed for 18~     months or until the first catheter related infection, death or catheter removal. The~     difference in catheter related infection rates will be compared between the two groups. We~     anticipate the results of this study will allow clinicians to prescribe the ointment most~     likely to reduce infections. By doing so this will reduce the complication rate associated~     with peritoneal dialysis and, ultimately improve survival.~   "
240976|NCT00400582|"~     The purpose of this study is to evaluate the impact of genetic variations on the response to~     candesartan in patients with heart failure who are already treated with an ACE inhibitor.~   "
240977|NCT00400569|"~     This is an open label single site Phase II clinical trial to identify a potentially promising~     therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1~     through 28 of each 42 day cycle. Treatment will be continued until there is either disease~     progression or cumulative/acute toxicity.~      All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma,~     liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt~     Cancer Center will be screened for eligibility to be enrolled in the study.~   "
240993|NCT00400361|"~     This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in~     patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma~     or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending~     doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of~     1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a~     satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose.~     The anticipated time on study treatment is until disease progression or dose-limiting~     toxicity, and the target sample size is <100 individuals.~   "
240978|NCT00400556|"~     Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients~     undergoing high dose therapy for the treatment of a range of cancers.~        -  HSPC are collected from the bloodstream after treatment with medications that cause the~          HSPC to move from the bone marrow into the bloodstream, a process called mobilization~        -  between 5 and 60% of patients can fail to collect enough HSPC for a transplant, using~          current mobilization techniques~        -  this study aims to assess the safety of combining a derivative of vitamin A, ATRA with~          G-CSF (the drug most commonly used to mobilize HSPC)~        -  ATRA has never been combined with G-CSF for mobilization of HSPC and therefore a study~          is needed to assess the safety of this combination, and whether it successfully~          mobilizes HSPC~   "
240979|NCT00400543|"~     Obstructive sleep apnea (OSA) is associated with adverse cardiovascular outcomes, including~     acute myocardial infarction and stroke. Atherosclerosis is an important step for these~     events. Recent studies demonstrated the independent association between OSA and validated~     markers of atherosclerosis. However, the impact of treatment with continuous positive airway~     pressure (CPAP) on these markers is unknown.~      The purpose of this study is to determine whether CPAP therapy can reverses early signs of~     atherosclerosis in apparently healthy OSA patients.~   "
240980|NCT00400530|"~     To compare upper GI handling of fosamax and generic, because the main AE profile of~     alendronate is before systemic absorption in the esophagus; differences could be relevant to~     the side effect profile.~   "
240981|NCT00400517|"~     RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different~     ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by~     blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide~     works in treating patients undergoing surgery for high-risk prostate cancer.~   "
240982|NCT00400504|"~     Patients with malignancies are at high risk of developing a thromboembolic complication and~     their treatment with chemo- and or radiation therapy further enhances this risk.~      Conventional haemostatic tests are not suitable as a screening tool of a hypercoagulable~     state. A hypercoagulable profile identified with the whole blood Thrombelastograph (TEG)~     Analyzer parameter maximal amplitude (MA) is reported to correlate with thrombotic events in~     patients undergoing major non-cardial surgery and recurrent ischemic events in patients~     undergoing percutaneous coronary intervention.~      In this study we investigate the correlation between TEG measurements and thromboembolic~     events in patients with newly diagnosed malignancies.~      The hypotheses of this study are:~        1. Patients with malignancies and hypercoagulability, defined as a TEG MA>69 mm and /or R<4~          min is at increased risk of developing thromboembolic complications as compared to those~          with a MA<69 mm and/or a R>4 min.~        2. Hypercoagulability and hence TEG R and MA values are affected by the treatment~          instituted in these patients (chemo and radiation therapy) rendering the patients more~          hypercoagulable and hence at increased risk of developing thrombotic complications.~   "
240983|NCT00400491|"~     The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000~     IU per week will result in improved metabolic control in patients with type 2 diabetes.~   "
240984|NCT00400478|"~     This is a randomized, open label, phase III study to evaluate the ability of rituximab~     maintenance therapy to prolong event-free survival in aggressive NHL.~      Patients will be screened after successful standard induction therapy (CR or Cru following~     standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8~     cycles). Patients will be followed until an event occurs as defined in the protocol. To~     evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in~     patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who~     have achieved a complete remission after appropriate first-line therapy, measured by~     event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm)~     will be recruited.~   "
240985|NCT00400465|"~     Thyroidectomy is an operation that is commonly performed. After an operation a pressure~     dressing by Hypafix is usually used due to the belief that it will help to reduce~     complications such as post-operative bleeding or haematoma. However, the practice is~     uncomfortable to patients and makes it hard to detect early haematomas.~      We carried out a prospective randomised study to study the role of pressure dressing after~     thyroid surgery by evaluating the amount of fluids collected in the operative bed by~     ultrasonography compared with normal dressing.~   "
240986|NCT00400452|"~     It is hypothesized that, compared to a control group, manual wheelchair users and their~     caregivers in the long-term-care setting who receive the wheelchair skills training program~     will improve their wheelchair skills to a statistically significant extent and will retain~     these improvements for at least one month.~   "
240987|NCT00400439|"~     This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with~     coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed~     study NC19453. Patients eligible to participate in the extension study will continue on the~     treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with~     concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6~     months post study NC19453, and the target sample size is approximately 100 individuals.~   "
240988|NCT00400426|"~     Palliative radiotherapy for head and neck cancer is widely used but the effect and side~     effects are largely unknown. We will study the effect of short hypofractionated palliative~     radiotherapy (20 Gy in 4 fractions) on symptom intensity and -frequency as weel as side~     effects~   "
240989|NCT00400413|"~     The aim of the research is to investigate phonological processing in deafness and to examine~     its influence on the neuroanatomy of reading.The basic hypothesis is that insofar as the~     ability to read is closely related to the ability to segment and represent speech units, the~     neuroanatomy of reading in deaf would be different from the one of hearing readers.~   "
240990|NCT00400400|"~     Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in~     gastrointestinal (GI) complications in some patients. This study will investigate the safety~     and tolerability of converting kidney transplant recipients with gastrointestinal symptoms~     from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated~     mycophenolate sodium (EC-MPS).~   "
240997|NCT00400309|"~     Primary objective:~        -  To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis~          vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus,~          Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of~          REPEVAX® administered one month after Placebo.~      Secondary objectives:~        -  To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy~          adults.~        -  To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after~          Td-IPV vaccine (REVAXIS®) or one month after Placebo.~   "
240998|NCT00400296|"~     This single arm study will determine the maximum tolerated dose, and recommended dose for~     further development, of R547, in patients with advanced solid tumors. Groups of patients will~     receive ascending doses of R547 as weekly intravenous infusions administered over a) 90~     minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of~     dose-limiting toxicity following the starting dose, incremental dose-escalations will be~     allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The~     anticipated time on study treatment is until disease progression or dose-limiting toxicity,~     and the target sample size is <100 individuals.~   "
240999|NCT00400283|"~     This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2~     diabetes.~   "
241000|NCT00400270|"~     All patients on the GP asthma database in one practice were invited for an asthma~     physical-therapy assessment, at baseline. Volunteers satisfying the inclusion criteria ie -~     aged between 16 and 70, able to understand, read and write English, give informed consent,~     willing to attend the surgery to take part in the trial and with no other serious conditions~     - were invited to participate in the study. Patients were randomised either to a control~     group, receiving 2 more assessments at 6 and 12 months, or for comparison to a group~     receiving 5 physical-therapy treatments of integrated breathing and relaxation exercises~     (known as the Papworth Method (PM)). The two groups would then be compared at 6 and 12~     months.~      Hypotheses:~        1. The PM of breathing and relaxation training would improve the quality of life for adult~          patients with asthma in primary care, compared with patients only receiving usual~          medical care.~        2. Anxiety and depression, and symptoms from dysfunctional breathing would reduce compared~          with the control group.~        3. Respiratory function measurements would improve compared with the control group.~   "
241001|NCT00400257|"~     The investigators are hoping to identify early heart failure in patients who do not have~     symptoms as yet and at the same time assess the usefulness of Brain natriuretic peptide (BNP)~     in doing this.~   "
241002|NCT00400244|"~     The purpose of this project is to develop French Canadian versions of the Wheelchair Skills~     Program (WSP). Translating a measurement instrument in the field of biomedical sciences~     requires not only the language to be taken into account but also the cultural context. We~     will determine the measurement properties of the WST-F and complete the randomized controlled~     trial on the efficacy of the WSTP-F.~   "
241003|NCT00400231|"~     Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl~     or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate;~     or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target~     dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C,~     insulin resistance, and markers of inflammation.~   "
241004|NCT00400218|"~     Evaluate the safety and anti-hypertensive efficacy of hyzaar(R) in patients with mild to~     moderate essential hypertension.~   "
241005|NCT00400205|"~     This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel,~     cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the~     oral cavity to determine what effects these agents may have on cancer cells.~   "
241006|NCT00400192|"~     Individuals who experience a traumatic injury often have a significant amount of blood loss~     and may require a blood transfusion. In some individuals who receive a blood transfusion,~     white blood cells from the donor's blood may remain in the body for years, a condition known~     as microchimerism. This study will examine the reasons why microchimerism occurs in some~     blood transfusion recipients and not others.~   "
241007|NCT00400179|"~     This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating~     the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced~     gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be~     randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm).~     Patients will be stratified by number of metastatic sites (one vs. more than one), locally~     advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or~     non-measurable disease, and center.~   "
241008|NCT00400166|"~     The purpose of this study is to determine whether Recovery Guide support services are~     effective in promoting recovery and social integration among psychiatrically disabled~     individuals who experience high rates of inpatient hospitalizations.~   "
241009|NCT00400153|"~     The primary objective of this study is to compare the effect of ipratropium~     bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20~     mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20~     mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of~     12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to~     COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent~     Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent~     Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed.~     In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of~     therapy will be characterized in a subgroup of patients.~   "
241010|NCT00400140|"~     The objective of this pilot study is to establish whether brief periods of high levels of~     acutely imposed myopic defocus can be used to slow the progression of myopia in children, as~     measured by changes in spherical equivalent refraction and axial length.~   "
241011|NCT00400127|"~     The objective of this study is to test the hypothesis that silicone suction suspension~     without additional belt support does not significantly diminish the postural sway or walking~     performance of persons with transfemoral amputation.~   "
241062|NCT00399438|"~     The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and~     colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome~     (D-IBS)~   "
241014|NCT00400088|"~     This study is being done to look at how well people respond to two very different drug~     treatments for depression. Clinically, people with depression can respond differently to drug~     treatments for reasons which are not always clear. Some of our own recent research suggests~     that people with depression who have a family history of bipolar disorder or completed~     suicide, may react differently to standard antidepressant medications than those without such~     a family history. Our data shows that family history of completed suicide, as well as the~     known predictor of family history of bipolar disorder, may help identify a pre-bipolar high~     risk group i.e. they currently have depression but at some future date will declare a bipolar~     illness (manic-depression) by virtue of development of a manic episode also. Our research~     suggests that treatment- emergent symptoms in response to a trial of antidepressant, such as~     agitation may be strong predictors of future bipolarity and inherently dangerous particularly~     as they are not ascribed to the antidepressant treatment. Finally, it is possible that this~     subgroup of those with depressive illness may respond better and more safely to lithium, a~     mood stabiliser used in known bipolar depression.~      The objective of this proposal is to investigate response to acute lithium treatment in~     subjects who meet the diagnostic criteria for major depression, but who are potentially at~     risk for bipolar disorder, by virtue of family history of bipolarity or completed suicide.~   "
241015|NCT00400075|"~     To assess the efficacy of systemic corticosteroids alone as first-line treatment of~     polyarteritis nodosa and microscopic polyangiitis without poor-prognosis factors as defined~     by the five-factor score (FFS=0), and to compare the efficacy and safety of azathioprine vs~     pulse cyclophosphamide as adjunctive immunosuppressive therapy to treat failure or relapse.~   "
241016|NCT00400062|"~     This will be the first large cohort study to define the epidemiology of and identify~     modifiable risk factors for long-term CI and functional deficits of ICU survivors. We will~     measure the independent contribution of risk factors such as delirium and exposure to~     sedative and analgesic medications to the incidence of long-term CI, controlling for~     established risk factors (e.g., age, pre-existing CI, and apoE genotype). Defining the~     contributions of these risk factors will make it possible to develop preventive and/or~     treatment strategies to reduce the incidence, severity and/or duration of long-term CI and~     improve functional recovery of patients with acute critical illness.~   "
241017|NCT00400036|"~     The objective of our research project is to determine the effects of fish protein, present in~     fish, on insulin sensitivity in insulin-resistant human individuals, and its mechanism of~     action on glucose metabolism. Our hypothesis is that fish protein improves insulin~     sensitivity, glucose tolerance and plasma lipid profile through an improvement in a primary~     defect in insulin signaling in overweight and insulin-resistant subjects.~   "
241018|NCT00400023|"~     This is a Phase 1, open-label, randomized, 2-sequence, cross-over, pharmacokinetic (PK) study~     evaluating the effect of the DPD inhibitory action of CDHP as an S-1 component compared with~     FT alone on the PK of 5-FU in patients with advanced solid tumors. The study will be~     conducted in 2 parts (Cross-Over Pharmacokinetic Phase and S-1 Extension Phase).~   "
241019|NCT00400010|"~     In a randomized controlled trial, patients recruited in a general hospital and fulfilling~     criteria for alcohol dependence, alcohol abuse or at-risk drinking will be randomly allocated~     to two conditions:(1) Transtheoretical Model (TTM)-based expert system group, patients~     receive an individualized feedback on drinking norms, health-related risks and core~     constructs of the TTM, augmented by a TTM-based manual, (2) Control group,receiving a booklet~     on health behavior.~      Outcome assessment will be conducted after 12 months. The hypothesis is that individualized~     feedback leads to greater reduction in alcohol consumption and elevated readiness to change~     at follow-up.~   "
241020|NCT00399997|"~     The purpose of this study is to evaluate the effect of a primary healthcare intervention~     called 'Exercise on Prescription' aimed at increasing level of physical activity in a~     population of sedentary patients with increased risk of developing lifestyle diseases. The~     effect is evaluated using both objective and patient-reported variables.~   "
241021|NCT00399984|"~     Inhaled corticosteroids taken on a daily basis have been proven to be the most effective~     treatment for children with persistent asthma. However, many pediatricians still do not~     prescribe daily corticosteroids to their asthmatic patients; this can lead to poor health~     outcomes among asthmatic children. This study will evaluate an interactive medical education~     program that focuses on improving pediatricians' asthma management skills and on encouraging~     increased corticosteroid use among their patients with asthma.~   "
241022|NCT00399971|"~     Our hypothesis is that ex vivo activated immune cells would produce multiple known and~     unknown potent hematopoietic cytokines, working in concert, these cytokines help stem cell~     growth and differentiation. Additionally, these cells travel and home to bone marrow as well~     as spleen and liver involved in hematopoietic activities, where direct cell-cell contact may~     be beneficial.~   "
241023|NCT00399945|"~     This study assesses the aerosol delivery characteristics (measured by in vivo lung~     deposition, nebulization time, serum tobramycin concentrations, and pharmacokinetic~     parameters) and safety of tobramycin inhalation solution administered for inhalation by PARI~     eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with~     compressor) in healthy subjects and in subjects with cystic fibrosis.~   "
241024|NCT00399932|"~     Non-alcoholic fatty liver disease (NAFLD) is now recognised as the hepatic complication of~     the metabolic syndrome of insulin resistance. In some patients, the disease can progress into~     steatohepatitis (NASH) which associates fatty liver, hepatocellular damage, chronic~     inflammation and variable and progressive fibrosis. The latter can evolve into cirrhosis and~     end-stage liver disease.~      Thus the presence of fibrosis sign the severity of the disease, and therefore its accurate~     detection is crucial for the identification of patients in need of treatment and appropriate~     follow-up.~      To date, histological examination of a biopsy of the liver is the gold standard in the~     diagnosis of fibrosis. the procedure is however associated with significant complication in~     0.01 to 0.1% of cases and with sampling errors because it analyses only a minimal portion fo~     the liver.~      The aim of the study is to evaluate, in a population of patients with the metabolic syndrome,~     whether non-invasive tests may identify those with hepatic fibrosis.~      At inclusion, serum tests, fibroscan (elastography of the liver by ultra-sounds) and~     elastography by MRI will be performed. Those tests will be repeated within 2 months.~      A liver biopsy will be performed if 2 out of the 3 (serum test, fibroscan or elastography)~     tests are suggestive of hepatic fibrosis.~      This study will allow to determine~        -  whether hepatic fibrosis may be detected by non-invasive means in patients with~          NAFLD/NASH.~        -  whether there is a correlation between non-invase tests and liver biopsy for assessment~          of fibrosis and it severity~        -  whether the presence of fatty liver interfere with the results of the fibroscan and the~          elastography.~        -  whether there are metabolic factors associated with an increased risk of fibrosis in~          this population.~   "
241063|NCT00399425|"~     To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the~     treatment of chronic foot ulcers in diabetic patients.~   "
241025|NCT00399919|"~     Patients with peripheral artery disease have decreased blood flow to exercising muscle~     causing pain. This decreased blood flow to the muscle affects the level of acylcarnitines~     which in turn decreases the level of carnitine. Carnitine allows muscles to function~     properly. This study will test the safety and efficacy of Propionyl-L-Carnitine taken in~     combination with a monitored exercise training program.~   "
241026|NCT00399906|"~     The purpose of this clinical research study is to learn if BMS-582949 alone is an effective~     treatment for moderate to severe psoriasis. The safety of the drug and the effectiveness of~     each dose will also be studied.~   "
241027|NCT00399893|"~     The purpose of this study is to investigate over a 6 month period the effect of octreotide~     therapy on food intake, sense of hunger, body weight, body composition, efficiency of burning~     calories, biomarkers of weight regulation and growth hormone markers in children and young~     Adults with Prader-Willi Syndrome(PWS).~   "
241028|NCT00399880|"~     Coronary heart disease (CHD) is the leading cause of death in the United States. Most people~     who die from CHD die of a heart attack. Acute coronary syndrome (ACS) is a term that includes~     mild heart attacks, as well as other episodes of chest pain that may serve as a warning sign~     for an upcoming heart attack.~      There are many medicines that can help prevent and treat ACS. However, at least 25% of~     patients don't take their medications as prescribed. When patients don't take their~     medications, we say they are noncompliant or nonadherent with the treatment.~      The period following hospital discharge is a vulnerable time for many patients. Patients are~     often confused about what to do when they return home from the hospital. Many patients don't~     take their medications correctly, or they don't take them at all. Patients with poor literacy~     skills have more trouble than others, because it is harder for them to follow written~     instructions. Overall, about half of the adults in the U.S. have poor literacy skills. It is~     important to develop ways to help these adults manage their health better.~      The purposes of this research project are 1) to learn more about the relationship between low~     literacy and medication adherence after hospital discharge, and 2) to test a strategy~     designed to help patients take their medicines more regularly. We will recruit consenting~     patients hospitalized with ACS. We will measure their literacy skills, ask questions about~     how they take their medicines, and measure other related factors like social support and~     self-efficacy. Patients will then be assigned to 1 of 2 groups. One group will receive only~     usual care at hospital discharge, which usually includes the nurse and physician briefly~     reviewing the medication prescriptions. The other group will receive an illustrated daily~     medication schedule and special, tailored counseling from a pharmacist at their time of~     discharge. About 1 week after patients leave the hospital we will contact them by phone to~     ask them questions about how they have been taking their medicines. We will get data from~     patients records for 6 months to see if the intervention had an impact on their medication~     compliance, blood pressure, cholesterol, and diabetes measurements.~      If this study is successful, this simple strategy could be implemented by hospitals to~     improve medication compliance after discharge. This study will also provide more information~     about how patients' literacy skills affect their medication compliance.~   "
241029|NCT00399867|"~     In vitro statins, inhibitors of the HMG-CoA-reductase, have been shown to overcome cell~     adhesion mediated drug resistance at very low concentrations. The purpose of the study is to~     investigate the in vivo efficacy of simvastatin as inhibitor of cell adhesion mediated drug~     resistance. Patients refractory to ongoing chemotherapy will receive concomitantly~     simvastatin and response will be monitored by paraprotein levels~   "
241030|NCT00399854|"~     The purpose of this study is to perform a clinical assessment of the efficacy of the device~     DHERMIA® (Industra Mecânica Fina Ltda)in the treatment of cellulite and body contouring~   "
241031|NCT00399841|"~     The primary objective of this study is to compare the efficacy and patient preference for~     spinal cord stimulation (SCS) using the Precision device with the electrode array placed at~     T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back~     or lower extremities and will have independently elected SCS as the next line of therapy.~     There is some anecdotal evidence that the coverage of the paresthesia resulting from T7~     placement is preferable to that obtained by the more commonly used T8 placement but there has~     been no study to support this observation.~   "
241032|NCT00399828|"~     The purpose of this study is to assess the efficacy of device TRI-ACTIVETM (DEKA M.E.L.A.,~     Itália)in the treatment od cellulite and body contouring.~   "
241033|NCT00399815|"~     Chronic viral hepatitis C is a frequent liver disease. It is associated with variable degree~     of hepatic fibrosis. To date, liver histology is still regarded as the gold standard to~     detect, diagnose and quantify liver fibrosis. This requires to perform a liver biopsy. Severe~     complications are associated to this procedure in 0.01 to 0.1% of cases. Because of this, the~     repetition of the biopsy to evaluate the progression of the disease or the response to~     treatment poses ethical questions. Also, liver biopsy only explore a minimal portion of the~     liver and liver fibrosis, which is not homogeneous, may be under- or over-estimated.~      To avoid risks linked to invasive technique and sampling errors associated to liver biopsy,~     efforts are being made to develop non-invasive technology to detect and quantitate liver~     fibrosis.~      In this study we will perform in patients with chronic hepatitis C, serum tests, fibroscan~     (elastography of liver parenchyma determined by ultra-sounds), and elastography of liver~     parenchyma by MRI.~      This study will allow~        -  to determine whether non-invasive tests effectively measure liver fibrosis~        -  to compare each non-invase test with results of liver biopsy~        -  to determine whether a non-invasive test or a combination of non invasive tests may be~          used to accurately evaluate liver fibrosis in patients with chronic hepatitis C.~   "
241034|NCT00399802|"~     This is a 4-week study to examine the effects of a new experimental medication on women with~     breast cancer and established bone metastases. This study will enroll approximately 45 women.~     The primary hypotheses are: (1) odanacatib will result in a substantial suppression of~     urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous~     (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822)~     will be safe and well tolerated during 4 weeks of treatment.~   "
241035|NCT00399789|"~     This is a study of the drug perifosine that consists of 2 parts. The first part of this study~     was designed to determine the highest dose of perifosine that can be administered to people~     every week without severe or prolonged nausea, vomiting and diarrhea. This study started with~     patients taking 900 mg/week and went up to 1800 mg/week. Part I of this study is completed.~     The MTD had been determined and incorporated in Part II.~      The goals in Part II are to:~        1. Compare the gastrointestinal toxicity of 3 different dose-schedules and~        2. Obtain preliminary information on the response rate of perifosine in non-small cell lung~          cancer.~   "
241064|NCT00399412|"~     The purpose of this study is to collect surface electrograms from standard and several~     non-standard configurations in patients with long QT syndrome, heart failure, cardiac~     resynchronization therapy or wide QRS during a routine outpatient assessment. The ECGs~     collected will be used as test signals by the sponsor for the development of a subcutaneous~     implantable defibrillator~   "
241036|NCT00399776|"~     We hypothesize that antipsychotic induced hyperprolactinemia can decrease bone mineral~     accrual and decrease bone mineral content (BMC) in adolescents on antipsychotic therapy.~      Specifics Aims~        1. To determine if antipsychotic therapy leads to decreased bone mineral accrual and~          decreased bone mineral content in a group of adolescents on antipsychotic therapy by~          comparing them to an ethnicity, gender and pubertal stage matched control group.~        2. To determine the relationship between serum concentrations of prolactin, sex steroids~          and bone turnover markers in adolescents on antipsychotic therapy and an ethnicity,~          gender and pubertal stage matched control group.~   "
241037|NCT00399763|"~     The purpose of this study is to find out whether atomoxetine (also called Strattera) helps~     teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol~     problems.~   "
241038|NCT00399750|"~     A randomized, controlled, open-label multicenter trial to assess the safety and efficacy of 3~     oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) + Bevacizumab (TREE1~     and TREE2) as first line therapy of advanced metastatic colorectal cancer.~   "
241039|NCT00399737|"~     Several milk proteins are precursors of peptides, released during fermentation, which possess~     various biochemical and physiological properties. Among them, some peptides have been~     reported to inhibit angiotensin-converting enzyme (ACE) in vitro (an enzyme implicated in~     blood pressure regulation) and to lower blood pressure (BP). in hypertensive rats and in a~     small sample of patients with hypertension. One possible mechanism for the BP lowering effect~     is inhibition of ACE. Prior investigating BP lowering effect of these peptides in a large~     cohort of hypertensive patients, it is necessary to assess in depth their potency to inhibit~     ACE in vivo in humans and to compare it to that induced by a well-known ACE inhibitor.~   "
241040|NCT00399724|"~     Primary objective:~        -  To determine the optimal treatment algorithm for the clinical use of insulin glargine~          based on the incidence of severe hypoglycaemia.~      Secondary objectives:~        -  To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and~          nocturnal hypoglycaemia.~        -  To determine the difference in glycaemic control as measured by HbA1c and fasting blood~          glucose between the treatment algorithms.~        -  To determine the difference in glycaemic control as measured by HbA1c and fasting blood~          glucose between baseline and end of treatment.~        -  To obtain safety data on the use of insulin glargine in each treatment algorithm.~        -  To measure change in subject weight and insulin dose between baseline and end of~          treatment.~        -  To determine subject quality of life and treatment satisfaction (sub-study)~   "
241041|NCT00399711|"~     This trial is conducted in the United States of America (USA). This trial compares the~     changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet~     given as twice daily versus three times daily regimens or versus twice daily rosiglitazone~     and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on~     monotherapy.~   "
241042|NCT00399698|"~     This study was developed in order to assess the effects of risperidone (Risperdal) as~     compared with placebo on cognitive-motor performance (attention, memory, and hand steadiness)~     and body movements.~      We propose to study the effects of risperidone on cognitive-motor performance in children~     already medicated for severe conduct problems. We would also like to look at safety by~     assessing these children for dyskinetic movements. We already have a sizable cohort of~     children maintained on risperidone. Our hypotheses are as follows:~        1. Risperidone will have no adverse effects on cognitive-motor performance in children who~          have received maintenance therapy for 4 to 20 months.~        2. Children tested during placebo will show no more dyskinetic movements than during~          risperidone treatment (i.e., there will be no unmasking of tardive dyskinesia).~   "
241043|NCT00399685|"~     The purpose of this study is to administer a combined oral contraceptive containing ethinyl~     estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to~     assess if the concentrations of the oral contraceptives change. The safety of this treatment~     regimen will also be studied.~   "
241044|NCT00399672|"~     Although injection drug users (IDUs) account for over 70% of new cases of HCV infection/year,~     there is no consensus on how to approach their medical care. In some Canadian centres,~     patients must be free of recreational drug use for as long as 6 months before being~     considered for HCV therapy. This is not consistent with current North American guidelines.~     Over the past 5 years, we have developed a successful program for the treatment of HIV~     infection in this population, based on a multi-disciplinary comprehensive program including~     directly observed therapy (DOT). Even though the duration of therapy for HCV is shorter than~     for HIV (as little as 6 months vs. life-long), we must address issues of administration of a~     weekly injection (interferon), twice daily pills (ribavirin) and the risk of significant side~     effects (including anxiety and depression) to successfully expand our program to treat this~     disease. Further, it may be that even if the program is successful, its benefits will be~     negated by HCV re-infection due to continued risk behaviors for its transmission.~   "
241045|NCT00399659|"~     This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation~     (OIC) in patients with non-cancer pain.~      Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA)~     receive the treatment as follows:~      Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study~     will remain on the same dose in the extension (double-blind).~      Patients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label)~      Patients who enter this study AFTER the core study interim analysis will receive the selected~     tegaserod dose regimen (open-label) determined by the core study IA.~   "
241046|NCT00399646|"~     The purpose of the Metricath Gemini System is to pre-dilate the target treatment area, take~     arterial lumen measurements in a native section of artery or within the deployed stent and~     perform further dilation of the deployed stent if required. In this manner, the Metricath~     Gemini System can assist the Interventionalist by providing arterial measurements prior to~     stenting, performing pre-stenting angioplasty, taking within stent measurements to help~     determine if the stent is fully deployed, and by performing post-stenting dilations to~     further dilate the stent if required.~   "
241047|NCT00399633|"~     The study aim at examining whether Sumatriptan changes the plasma values of the neuropeptides~     vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary~     adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2~     og PGF2α.~   "
241048|NCT00399620|"~     Periodontitis is a chronic disease of the supporting tissue of the teeth, characterized by~     bleeding and inflamed gingival, resorption of alveolar bone. This disease has a significant~     impact of the quality of life as the teeth become progressively mobile and may fall out~     spontaneously if no treatment is provided. Periodontal disease has been cited as the sixth~     complication of diabetes mellitus.Chromogranins / secretogranins are a family of proteins~     present in nervous endocrine and immune cells, released with catecholamines during stress~     situations. Chromogranin A (CGA) is the major member of this family.The aim of this study is~     to determine the level of CGA and its derived peptides in the gingival crevicular fluid (GCF)~     of health or diabetic patients with and without periodontitis.Then, we want to determine the~     antimicrobial activity of these peptides.~   "
241049|NCT00399607|"~     The study team has developed a set of biomarkers of risk for colon cancer; this study tests~     1) whether or not calcium and/or vitamin D supplementation can favorably affect these~     biomarkers in persons who are at higher than average risk for colon cancer (ie, have already~     undergone the removal of colon growths, called adenomatous polyps, which are known to be~     precursors to developing colon cancer), and 2) whether effects on the biomarkers predict who~     will get new colon polyps or not.~   "
241050|NCT00399594|"~     Identifying & optimizing strategies to reduce the burden of heart failure is vital. Despite~     advances in pharmacotherapy, patients with heart failure are at high risk for death &~     hospitalization. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical~     activity, improves cardiac output & reduces HF symptoms. However, ~50% of patients do not~     clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an~     important reason for non-response.~      This study will assess whether targeted LV lead placement will result in an increased~     probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement.~   "
241051|NCT00399581|"~     Acute respiratory distress syndrome (ARDS) is a severe lung condition that causes respiratory~     failure. Individuals with ARDS often require the use of an artificial breathing machine,~     known as a mechanical ventilator. High frequency oscillatory ventilation (HFOV) is a form of~     mechanical ventilation that pumps small amounts of air into the lungs at a constant high~     rate. The purpose of this study is to compare the safety and efficacy of two HFOV methods in~     individuals with ARDS.~   "
241052|NCT00399568|"~     This study will be investigating the efficacy and safety administration of multiple doses of~     intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.~   "
241053|NCT00399555|"~     There have been many improvements in the care of children with hypoplastic left heart~     syndrome (HLHS). This has helped these children survive longer. Because these children now~     live longer, researchers are recognizing developmental disabilities (the children are behind~     in their thinking or physical activity) in children with hypoplastic left heart syndrome. The~     purpose of this research study is to help the investigators learn more about developmental~     disabilities in children with hypoplastic left heart syndrome.~      During the time of your child's first surgery for hypoplastic left heart syndrome, a monitor~     was placed on your child's forehead to measure the oxygen levels in the brain. This monitor~     is called Near Infrared Spectrometry (NIRS). The researchers involved in this study want to~     know if oxygen levels in the blood vessels of the brain have any effect on developmental~     disabilities later in life in children with hypoplastic left heart syndrome. The researchers~     plan to enroll 60 research subjects.~   "
241054|NCT00399542|"~     The primary purpose of this study is to evaluate the efficacy and safety of administration of~     lubiprostone in patients with irritable bowel syndrome with constipation.~   "
241055|NCT00399529|"~     This is a feasibility study to examine combination therapy with Trastuzumab (T),~     Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine in~     patients with Stage IV HER-2/neu-overexpressing breast cancer. The main purposes of this~     study are to test the safety, clinical benefit, and bioactivity of vaccine therapy in~     combination with Cyclophosphamide and Trastuzumab in patients with HER-2/neu-overexpressing~     Stage IV breast cancer. This study will also to test whether the Cyclophosphamide can~     eliminate the suppressive influence of regulatory T cells, and whether Trastuzumab can~     increase antigen processing and presentation. These drug activities may make the immune~     system react better and enhance the effects of the vaccine in treating breast cancer. The~     vaccine consists of two irradiated allogeneic mammary carcinoma cell lines genetically~     modified to secrete human granulocyte-macrophage colony stimulating factor (GM-CSF). This~     open label, single arm study is designed to recruit up to 40 subjects to identify 20 research~     subjects with HER-2/neu-overexpressing Stage IV breast cancer eligible for study treatment.~   "
241056|NCT00399516|"~     The primary objective of this study is to assess the effects of varying pulse width in~     suprathreshold dorsal column stimulation in patients with low back pain.~   "
241057|NCT00399503|"~     This study evaluates the usefulness of noninvasive tests of the structure of the heart and~     the nervous system controlling the heart. It will assess whether combining tests that~     evaluate heart structure with others that measure the nervous system controlling the heart~     will identify most patients who develop serious heart rhythm problems after a heart attack.~   "
241058|NCT00399490|"~     Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have~     previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624~     on an open-label basis.~   "
241059|NCT00399477|"~     Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at~     their first visit based on the drugs they are taking for their PD:~        -  Group 1 Patients using Azilect and no other therapy.~        -  Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.~   "
241060|NCT00399464|"~     The primary objective of the study is to demonstrate the superiority of SL77.0499-10 10mg~     once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12~     weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms~     related to BPH.~      The secondary objective is to assess the safety of SL77.0499-10 in patients with lower~     urinary tract symptoms related to BPH in comparison with placebo and tamsulosin~     hydrochloride.~   "
241061|NCT00399451|"~     The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of~     pharynx for OSAS & SS,to reduce pharyngeal compliance.~   "
241065|NCT00399399|"~     To assess the efficacy of systemic corticosteroids alone as first-line treatment of~     Churg–Strauss syndrome without poor-prognosis factors as defined by the five-factor score~     (FFS=0), and to compare the efficacy and safety of azathioprine vs pulse cyclophosphamide as~     adjunctive immunosuppressive therapy to treat failure or relapse~   "
241066|NCT00399386|"~     The primary goal of this protocol is to collect ECG signals from paediatric patients using 4~     surface electrodes placed in the configurations proposed for the Cameron Health, Inc.~     subcutaneous implantable defibrillator (S-ICD) system. These signals will then be used to~     test the S-ICD system for future use in paediatric patients.~   "
241067|NCT00399373|"~     The study seeks to measure the effect of increased coordination of care on medical costs,~     treatment utilization and selected clinical indicators among a Medicaid population with~     chronic medical conditions and substance abuse problems? We shall address this question by~     conducting a demonstration project consisting of the provision of integrated care management~     (somatic and behavioral) to Medicaid enrollees living on the Eastern Shore of Maryland and~     who have both chronic medical conditions and problems with substance abuse. A specific~     component of the study will be the participation of Maryland's Mental Health Administration~     (MHA) and MAPS, the administrator of psychiatric services for the Medicaid enrollees in~     Maryland. We shall compare the results of the integrated care management for the study sample~     on the Eastern Shore with a control group from the counties of western Maryland.~   "
241068|NCT00399360|"~     A healthy diet and exercise have improved the health of people without human immunodeficiency~     virus (HIV) who have Metabolic Syndrome. In this study we would like to find out if the same~     benefit can be seen in people with HIV and Metabolic Syndrome. Patients with Metabolic~     Syndrome usually have a large waist, high blood cholesterol levels, high blood pressure, and~     high blood sugar levels. These are risk factors, which may increase one's chance of~     developing heart disease and/or diabetes. The purpose of the study is to evaluate the effects~     of different methods of treating HIV associated Metabolic Syndrome. The groups are: 1) a~     lifestyle modification program plus metformin (also known as glucophage), 2) lifestyle~     modification plus placebo, 3) metformin alone or 4) placebo alone. The lifestyle modification~     program consists of nutrition and exercise sessions with the goal of improving body~     composition, heart health, and ways to lower the risk of developing diabetes.~   "
241069|NCT00399347|"~     The prevalence and incidence of diabetes has been reported to vary among~     populations.Immigrants groups as that have undergone significant life-style changes tend to~     develop diabetes within a short time. The aim of the study is to assess the prevalence of~     diabetes mellitus in Ethiopian population ,15-20 years after immigration in Israel.~   "
241070|NCT00399334|"~     The purpose of this study is to evaluate epidemiological characteristics of patients that~     experience relapse and need an admission in psychiatric acute units across Spain.~   "
241071|NCT00399321|"~     The main purpose of this study is to see what levels of Bone Mineral Density post-menopausal~     women with breast cancer have, and to see if the level of Bone Mineral Density changes during~     a women's treatment after her surgery.~      This trial studies changes in Bone Mineral Density and markers of of bone activity in~     post-menopausal women receiving treatment for early stage breast cancer.~   "
241072|NCT00399308|"~     This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg~     ulcers and to give preliminary information about the efficacy of two different Celaderm(TM)~     dosing regimens.~   "
241073|NCT00399295|"~     The purpose of this study was to compare the pharmacokinetic (the way a drug enters and~     leaves the blood and tissues over time) profile of Dilaudid OROS 16mg (Dilaudid Slow Release;~     hydromorphone HCL) administered under fasting conditions, following a high-fat breakfast~     meal. The study also examined the effect of naltrexone blockade on the pharmacokinetic~     profile of Dilaudid SR.~   "
241074|NCT00399282|"~     The purpose of this study is to determine whether simultaneous supplementation with omega-3~     fatty acids and vitamin E is effective in the treatment of patients with rheumatoid~     arthritis.~   "
241075|NCT00399269|"~     To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic~     Renal Failure.~   "
241076|NCT00399256|"~     Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological~     prophylaxis (e.g. N–acetylcysteine; NAC) is controversially discussed. So far, in all~     interventional studies assessment of kidney function was based on measurements of serum~     creatinine although this surrogate biomarker has several limitations. We investigated the~     antioxidants NAC and zinc (Zn) for the prevention of CIN by monitoring concomitantly serum~     levels of creatinine and cystatin C.~   "
241077|NCT00399243|"~     This study's hypothesis is the 4mg StatDose sumatriptan is effective for the acute treatment~     of cluster headache and provides good safety and tolerability across multiple doses of the~     study medication as well as across multiple attacks of cluster headache. This study seeks to~     determine the safety and efficacy of the commercially available 4mg StatDose formulation of~     sumatriptan as an acute treatment of cluster headache. Patients are allowed to use repeated~     dose of the study medication for a given headache if they have had a partial response to the~     first dose. They may treat up to 3 attacks of cluster headache with the study medication.~     Safety assessment will be through adverse event reporting and physical examination. Patients~     with both episodic cluster headache as well as chronic cluster headache will be studied.~     Patients must either not have started preventive treatment for cluster headache or be on a~     stable dose of preventive medication.~   "
241078|NCT00399230|"~     To evaluate the effectiveness of NGT (Optive) vs. Systane Tears for patients with moderate to~     severe dry eye disease.~   "
241079|NCT00399217|"~     The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous~     implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter~     defibrillator (ICD)for treating ventricular tachyarrhythmias. The S-ICD electrode and pulse~     generator emulator will be briefly implanted and tested during the standard implantation~     procedure of an ICD, but then the S-ICD system will be removed entirely.~   "
241080|NCT00399204|"~     The study aims to see if there is any significant difference in the cardiovascular outcomes~     in type 2 diabetes patients who are treated with pioglitazone or Metformin~   "
243018|NCT00373490|"~     This is a clinical study to evaluate the safety and pharmacokinetics of an overseas~     determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient~     population with solid tumors.~   "
241081|NCT00399191|"~     The objective of the study is to develop a simple, noninvasive test for evaluation of iron~     absorption as a tool to determine the cause of iron deficiency anemia. Healthy, premenopausal~     women with iron deficiency with or without anemia will be recruited for the study.~     Participants will, over the course of two months, ingest an iron solution three times; after~     each iron ingestion, participants will collect their stool and bring it to the study~     investigators for assessment of iron content.~   "
241082|NCT00399178|"~     To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who~     are sub-optimally treated with current analgesic. Those patients may benefit from treatment~     with a long lasting analgesic.~   "
241083|NCT00399165|"~     The protocol was designed to address the hypothesis that oral testosterone enanthate plus~     dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In~     addition, we will compare the gonadotropin suppression mediated by a dose of testosterone~     enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in~     the normal range throughout the day, with the same dose (800 mg once daily) administered once~     daily. This larger once-daily dose is expected to result in a higher peak and lower trough by~     the end of the dosing interval~   "
241084|NCT00399152|"~     This study is a Phase I trial in two parts. In part 1, a MTD to the combination of perifosine~     and sunitinib malate will be determined. In part 2, with the MTD as a starting point, a group~     of patients will be accrued with the goal of ensuring that they will be able to tolerate at~     least two courses of therapy, which would make them evaluable for response in a Phase II~     study.~   "
241085|NCT00399126|"~     This is a study of the drug perifosine given in combination with paclitaxel. Perifosine is an~     oral anti-cancer agent that has been used in more than 140 people. Paclitaxel is a standard~     chemotherapy agent used in many types of cancer. This study is designed to determine the~     highest dose of perifosine that can be administered to people every day while they are~     receiving paclitaxel in one of two regimens, without severe or prolonged nausea, vomiting and~     diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day.~   "
241086|NCT00399113|"~     The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients~     with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order~     to provide information on how the monoclonal antibody is distributed throughout the body and~     to assess tumor targeting. No therapeutic dose of radiation will be given in the first study.~   "
241087|NCT00399100|"~     People who has been in a fire accident have been shown often to be cyanide poisoned as well~     as poisoned with carbon monoxide(CO). According to recommendations from the Danish Health~     Agency people who are CO poisoned must be treated with hyperbaric oxygen (HBO). We want to~     see if HBO treatment can also treat cyanide poisoning.~      The hypothesis is that as cyanide binds the same place in the mitochondria as CO cyanide will~     be detached from the mitochondria like CO and diffuse back to the blood.This way it will be~     easier to treat with hydroxycobalamin.~   "
241088|NCT00399087|"~     This is a study of the drug perifosine given in combination with docetaxel. Perifosine is an~     oral anti-cancer agent that has been used in more than 140 people. Docetaxel is a standard~     chemotherapy agent used in many types of cancer. This study is designed to determine the~     highest dose of perifosine that can be administered to people every day while they are~     receiving docetaxel with or without a steroid called prednisone, without severe or prolonged~     nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up~     to 150 mg/day.~   "
241089|NCT00399074|"~     Malaria is fatal and increases the risk of death among children with sickle cell anemia.~     Chemoprophylaxis significantly improves quality of life in these children. In Uganda~     Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due~     to high levels of resistance throughout the country. Intermittent presumptive treatment with~     sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential~     in reducing incidence of malaria and anaemia among high risk groups such as pregnant women~     and infants. However no studies have been done in Uganda to determine if presumptive~     treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with~     sickle cell anaemia.~      Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly~     chloroquine in reducing incidence of malaria in children with sickle cell anaemia.~   "
241090|NCT00399061|"~     The purpose of this study is to evaluate the efficacy of Optive versus Systane used~     concomitantly with topical cyclosporine for the treatment of dry eye.~   "
241091|NCT00399048|"~     The purpose of this study was to characterize the effectiveness and safety of OROS~     hydromorphone HCL and OxyContin in patients with chronic osteoarthritis (OA) of the knee or~     hip who are receiving chronic nonsteroidal anti-inflammatory drug (NSAID) or other~     nonsteroidal, non-opioid analgesic (ie, acetaminophen or aspirin) therapy.~   "
241092|NCT00399035|"~     The purpose of this study is to determine if Cediranib when added to chemotherapy is more~     effective than chemotherapy alone in prolonging life expectancy and slowing disease~     progression in patients with previously untreated metastatic colorectal cancer.~   "
241093|NCT00399022|"~     Testing the efficacy of the SNRI medication Duloxetine for treating OCD patients who did not~     respond to SSRI~   "
241094|NCT00399009|"~     After removing the rectum at surgery, bowel continuity can sometimes be restored by an~     anastomosis between the anus and the bowel. This anastomosis is most commonly created by the~     use of surgical circular stapling instruments. In a retrospective pilot study the risk of~     developing an acute leak in the anastomosis was increased with one of the most commonly used~     instruments in Sweden as compared to the other brand in use. In the current study the patient~     is randomized to either one of the instruments after a resection of the rectum for rectal~     cancer.~   "
241122|NCT00398632|"~     Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors~     (SSRIs). The hypotheses of this study are that:1. subjects with major depression or dysthymia~     who are being treated with an SSRI and experiencing treatment-related sexual dysfunction will~     experience less sexual dysfunction if they are switched to duloxetine, and 2. they will~     experience either improved antidepressant response or no loss of antidepressant response.~   "
241123|NCT00398619|"~     The purpose of this study is to determine whether the investigational drug INCB013739 has an~     effect on systemic and adipose tissue 11-HSD1 activity in obese, insulin resistant subjects.~   "
241095|NCT00398996|"~     This is a randomized, open-label study comparing three existing treatment strategies of ART~     initiation in HIV/TB co-infected patients:~      Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon~     completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion~     of the continuation phase of TB treatment~      Approximately 700 men and women ≥ 18 years of age with documented HIV infection and~     smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients~     will be offered antiretroviral therapy (ART), starting at one of the three time points listed~     above through the CAPRISA AIDS treatment programme which includes extensive counselling and~     adherence support. The study participants will be followed for 18 months to assess the~     primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients~     on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load,~     opportunistic infections.~   "
241096|NCT00398983|"~     The goal of this clinical study is to find out whether continued therapy with decitabine~     after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the~     remission and prevent relapse of the disease.~   "
241097|NCT00398970|"~     Bronchoscopy of non visible lesions in the lung, have a low diagnostic yield. The use of~     endoscopic ultrasound might increase the diagnostic yield. This prospective study randomises~     between bronchoscopy with the use of a ultrasound miniprobe and bronchoscopy without the use~     of a miniprobe in clinical practice at Haukeland University Hospital.~      The study hypothesis:~      The use of the ultrasound miniprobe will increase the diagnostic yield of bronchoscopy in non~     visible lesions.~   "
241098|NCT00398957|"~     The primary objective of this study was to examine the OROSÂ® Hydromorphone HCL~     pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile~     for dose proportionality after administration of 8mg, 16mg, 32mg and 64 mg tablets.~   "
241099|NCT00398944|"~     The purpose is to determine wether an electronic decision support system based on national~     guidelines is effective to improve the follow-up and the treatment of two conditions:~     hypertension and diabetes, in primary care practices.~   "
241100|NCT00398931|"~     This study was conducted among women who had previously received alendronate for 3 to 6 years~     during the Fracture Intervention Trial (FIT). Participants in the FLEX study were randomly~     assigned to receive alendronate (either 5 or 10 mg/day) or matching placebo during the next 5~     years, in order to evaluate the effects of continuing or discontinuing alendronate treatment~     on bone mineral density and biochemical markers of bone turnover.~   "
241101|NCT00398918|"~     This is a pilot study in which our intent is to establish an alcohol administration~     laboratory in which we will be able to test the effect of the anticonvulsant medication~     zonisamide as compared to placebo on alcohol self administration and on cognitive functioning~     in non treatment seeking heavy users of alcohol. Our first goal is to establish the safety of~     zonisamide when used together with alcohol. Our second goal is to test the effect of an acute~     dose of zonisamide on alcohol consumption and show that it may reduce the consumption of~     alcohol. To achieve this goal we seek subjects with a history of heavy drinking to be tested~     on the self-administration procedures described below in two sessions with either zonisamide~     or placebo. These procedures will involve first, the administration of a challenge dose of~     ethanol to evaluate the effect of alcohol on performance on neuropsychological tests. This~     initial challenge will be followed by a period of alcohol self-administration in which the~     research subject can choose to select either ethanol or another reinforcer, money.~   "
241102|NCT00398905|"~     Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The~     administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that~     risk, but heparins have to be applied by injections below the skin. The purpose of this study~     was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the~     licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated~     phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and~     widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In~     this study 5 different doses of the investigational drug BAY 59-7939 were tested in~     comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily~     (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg~     total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg~     total daily dose). This study ran for approximately 7 months in a number of countries. In~     total, 726 patients were enrolled in this study.~   "
241103|NCT00398892|"~     Hypothesis: that lipoic acid supplements taken orally will improve control of blood sugar~     levels in people with type 2 diabetes.~      This study will recruit 18 people with type 2 diabetes, whose diabetes is currently managed~     on oral agents. Each subject will then either take placebo for 12 weeks followed by lipoic~     acid for 12 weeks, or lipoic acid followed by placebo.~      A blood test for overall diabetes control will be taken at the start and end of each 12 week~     period, and the change in control will be compared for lipoic acid vs placebo.~   "
241104|NCT00398879|"~     This is an exploratory phase 2, randomized placebo-controlled trial with stratification for~     disease and chemotherapy type. The study is subsequently closed to enrollment in all arms~     except patients with metastatic colorectal cancer which would be randomized to either~     capecitabine plus perifosine or capecitabine alone.~      The effects of perifosine may be manifested by increased time to progression, tumor~     regression reflected in partial or complete responses, or a combination of these outcomes.~     The primary goal of this trial is to obtain a preliminary and objective assessment of the~     effects of perifosine on time to progression.~   "
241120|NCT00398658|"~     Purpose: To evaluate the efficacy of combined intraocular injection of gentamycin and~     clindamycin in prevention of acute posttraumatic bacterial endophthalmitis (APBE) following~     penetrating eye injuries.~      Design: Multicenter, randomized, double masked, controlled trial. Participants: Three hundred~     forty six eyes of 346 patients with penetrating eye injury.~      Method: Following primary repair, eyes were randomized to receive a 0.1 ml intracameral or~     intravitreal injection of 40µg gentamycin and 45µg clindamycin (cases), versus intracameral~     or intravitreal injection of 0.1ml balanced saline solution (controls). All patients received~     standard prophylactic antibiotic therapy (systemic, subconjunctival and topical).~      Main outcome measures: Occurrence of endophthalmitis within two weeks after primary repair.~   "
241121|NCT00398645|"~     This study is designed to determine if the investigational drug is effective and safe in~     individuals with asthma.~   "
241105|NCT00398866|"~     Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and~     that is often low in people with osteoarthritis. Although hyaluronan has been used in~     millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb.~     The purpose of this study is to determine the safety and effectiveness of hyaluronan in~     relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids~     and local anesthetic.~      The principle hypothesis is that treating osteoarthritis at the carpometacarpophalangeal~     (CMC) joint with injectable hyaluronan will results in greater pain relief, higher patient~     satisfaction, and better functional outcomes than treating with placebo injections (local~     anesthetic) or with corticosteroid injections. Treating CMC osteoarthritis with~     corticosteroid injections will result in greater pain relief, higher patient satisfaction,~     and better functional outcomes than treating with placebo injections. Patients with worse~     pre-treatment function will have less improvement and worse post-treatment results after~     administration of corticosteroid or hyaluronan.~   "
241106|NCT00398853|"~     The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis~     of the study was to evaluate the effect of supplementing the diet of individuals with Type 2~     diabetes with chromium picolinate and assessing the effect of the supplementation on insulin~     sensitivity as assessed with hyperinsulinemic clamps~   "
241107|NCT00398840|"~     This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion~     (IVI) into a peripheral vein weekly.~      Patients with advanced solid tumors, who are refractory to available therapy or for whom no~     standard systemic therapy exists, will be enrolled.~   "
241108|NCT00398827|"~     The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as~     compared to placebo when used for the sedation of subjects requiring monitored anesthesia~     care (MAC).~   "
241109|NCT00398814|"~     This study is a Phase I trial in two parts. In part 1, a MTD to the combination of perifosine~     and sorafenib will be determined. In part 2, with the MTD as a starting point, a group of~     patients will be accrued with the goal of ensuring that they will be able to tolerate at~     least three courses of therapy, which would make them evaluable for response in a Phase II~     study.~   "
241110|NCT00398801|"~     The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology,~     natural history, clinical course, and other outcomes of gastroparesis.~   "
241111|NCT00398788|"~     The purpose of the study was to characterize the safety, effectiveness, and impact on quality~     of life (QOL) measures of OROSÂ® hydromorphone HCL in patients with chronic low back pain.~   "
241112|NCT00398775|"~     The purpose of this study is to determine whether new blood test (procalcitonin) can help to~     reduce unnecessary use of antibiotics in patients with unexplained fever.~      Although fever is most commonly caused by bacterial infection there are multiple other~     conditions that can cause fever. It can be caused by viral infection. It can also be caused~     by other non infectious disease. Patients with malignancy, inflammation (such as gout or~     arthritis), or clots in veins can present with fever. Occasionally medications themselves can~     cause fever. If fever is not caused by infection antibiotics will not help. Instead they may~     cause side effects such as diarrhea and allergic reactions. We want to determine whether~     simple blood test (procalcitonin) can help us to make a difference between fever caused by~     infection and fever caused by others (above mentioned) non-infectious problems. We also want~     to determine whether such test would help us to reduce unnecessary antibiotic use and help us~     to find faster the real cause of the fever.~      A total of 90 patients with the unexplained fever will be participating in this study. This~     study will involve single, additional blood test, performed only if patient continue to have~     fever despite a few days of investigations and therapy with antibiotics.~      Patients will be assigned by drawing to one of two groups. In the first group blood test~     (procalcitonin) will help a doctor to decide whether to stop or continue antibiotics. If~     procalcitonin level is high antibiotics will be continued and the doctor will most probably~     order additional tests to determine the source of infection. If procalcitonin level is low~     serious bacterial infection is unlikely. The antibiotics will be stopped and a doctor will~     try to look for other cause of fever.~      In the second group blood for the tests will be collected but not reported to a doctor. You~     will be treated in traditional manner by a doctor.~      By following this procedure we will be able to determine whether therapy guided by~     procalcitonin level is as safe and possibly more effective than traditional approach. This~     study does not involve any other tests or study medications. We will attempt to contact all~     patients one month later by phone to determine whether you remain well after discharge.~   "
241113|NCT00398749|"~     The main purpose of this study is to evaluate the safety and efficacy (% response) of epoetin~     alfa in the treatment of anemia in adults receiving chemotherapy for cancer.~   "
241114|NCT00398736|"~     To evaluate the use of sonographic inferior caval vein assessment in mechanically ventilated~     septic patients.~      Volume assessment in mechanically ventilated patients with inflammation is of major~     importance to guide fluid therapy. The researchers investigated whether measurement of caval~     vein diameter correlates with invasively assessed volume-based hemodynamic parameters.~   "
241115|NCT00398723|"~     The study offers narrowband UVB light therapy to patients who have 5% of their body involved~     with vitiligo.~      The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.~   "
241116|NCT00398710|"~     This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is~     designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a~     two-stage phase II study design to permit early stopping of the trial if there is strong~     evidence that the study regimen is inactive. In addition, it will assess toxicity of this~     drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be~     assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks.~   "
241117|NCT00398697|"~     This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral~     anti-cancer agent that has been used in more than 140 people, but has not been combined with~     other drugs before this study. The study is designed to determine the highest dose of~     perifosine that can be administered to people every day while they are on a Gemcitabine~     regimen, without severe or prolonged nausea, vomiting and diarrhea. This study starts with~     patients taking 50 mg/day and goes up to 150 mg/day. After the highest tolerable dose is~     found, we will add 10 more patients at that dose.~   "
241118|NCT00398684|"~     The purpose of this study was to assess the efficacy of a single dose of the drug nevirapine~     (NVP) given to pregnant women at onset of labor and to their infant 48-72 hours after birth~     in addition to standard oral zidovudine (ZDV or AZT) prophylaxis for the prevention of~     mother-to-child transmission of HIV-1.~   "
241119|NCT00398671|"~     This study shall investigate the feasibility of the use of cool-caps in the preclinical~     setting in patients with successful primary cardio-pulmonary resuscitation Hypothesis:~     cool-caps are efficient and feasible to use in the preclinical setting in patients after~     successful CPR.~   "
241124|NCT00398606|"~     The purpose of this study is to see how well alendronate and calcium as compared to calcium~     alone increase bone density in postmenopausal women with osteoporosis~   "
241125|NCT00398593|"~     Ulcerative Colitis is associated with a significantly increased risk of colorectal cancer.~     This risk can be reduced through regular medication with 5ASA compounds. Their effectiveness~     however is limited by poor adherence to the treatment protocols by many patients.~      The hypothesis which underlies this proposal is that if the factors responsible for poor~     compliance can be identified, interventions could be developed which would help to overcome~     the barriers which exist in individual patients. These interventions would be based on the~     reasons for non-adherence, specifically tailored to the needs of the individual. As a result~     such interventions will improve patients' adherence with prescribed 5ASA and therefore reduce~     the relapses of the disease and a cancer risk.~   "
241126|NCT00398580|"~     The combination of testosterone and dutasteride is intended for use in hypogonadal men. This~     study will evaluate the effect of 28-day repeat dosing of this combination with varying BID~     doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well~     as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the~     effects of each compound on the other, and to look for any safety problems that may result~     when the 2 drugs are given together.~   "
241127|NCT00398567|"~     The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in~     combination with trastuzumab in patients with advanced breast cancer.~   "
241128|NCT00398554|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving combination~     chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying the side effects and how well combination~     chemotherapy works in treating young male patients with Hodgkin's lymphoma.~   "
241129|NCT00398541|"~     Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in~     comparison with Natrilix(TM).~   "
241130|NCT00398528|"~     Impaired short term memory, attention and concentration lapses, and slower processing of~     information occur in up to 40-65% of patients with Multiple Sclerosis (MS). The quality of~     life of individuals with MS is impacted to the degree with which they experience these~     symptoms.~      There are several medications approved by the United States Food and Drug Administration~     (FDA) to treat MS symptoms and to modify (slow) disease course. Traditional approaches to~     determining the effectiveness of medications used in treating MS rely on reports of the~     number of relapses an individual experiences, as well as standard clinical tests, such as the~     Kurtzke Expanded Disability Status Scale (EDSS).~      This research study will look at whether the functional magnetic resonance imaging (fMRI)~     scan can be used as a tool for measuring changes in the brain associated with treatment in MS~     patients. Unlike a typical MRI which provides structural information about the brain, the~     fMRI provides information about brain activity during performance of cognitive or motor~     tasks.~   "
241131|NCT00398515|"~     This phase I trial is studying the side effects and best dose of temsirolimus when given~     together with lenalidomide in treating patients with previously treated multiple myeloma.~     Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer.~     Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus~     may also stop the growth of cancer cells by blocking some of the enzymes needed for their~     growth. Giving lenalidomide together with temsirolimus may kill more cancer cells.~   "
241132|NCT00398502|"~     Primary: To determine the relative bioavailability of MOA-728, an investigational drug,~     administered orally in both the capsule and tablet formulations to methadone maintenance~     subjects.Secondary: To assess the pharmacodynamic effect of MOA-728 administered both orally~     and subcutaneously to methadone maintenance subjects using the oral-cecal transit time.~   "
241133|NCT00398489|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, epirubicin, and cyclophosphamide,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     chemotherapy with or without monoclonal antibody therapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving these~     treatments after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving docetaxel, epirubicin, and~     cyclophosphamide with or without trastuzumab works in treating women with locally advanced~     breast cancer that can be removed by surgery.~   "
241134|NCT00398476|"~     The objectives of this study are to evaluate and compare patient preference for FF~     (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of~     allergic rhinitis following single-dose administration.~   "
241135|NCT00398463|"~     This study will evaluate whether adding tirofiban, administered at high bolus dose on top of~     aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction~     after percutaneous coronary intervention in elective patients presenting with aspirin and/or~     clopidogrel resistance.~   "
241136|NCT00398450|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together~     with interferon alfa may be an effective treatment for melanoma.~      PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when~     given together with interferon alfa in treating patients with metastatic melanoma.~   "
241137|NCT00398437|"~     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help doctors~     find CNS metastases and plan treatment.~      PURPOSE: This randomized clinical trial is studying how well MRI finds CNS metastases in~     women with stage IV breast cancer.~   "
241138|NCT00398424|"~     This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites~     in patients with advanced solid tumors and varying degrees of hepatic function defined by the~     NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts-~     Normal, Mild, Moderate or Severe.~      Six patients will be enrolled inot each cohort and receive S-1.~   "
241157|NCT00398151|"~     To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from~     peripheral blood after newly initiated montelukast therapy.~   "
241139|NCT00398411|"~     This study investigates whether the prophylactic use of moxifloxacin during high-dose~     chemotherapy followed by autologous stem cell transplantation reduces the incidence of~     clinically significant bacteremia.~      Further investigations include time to occurrence of fever, duration of fever, overall~     survival and antibiotic sensitivity of blood isolates.~   "
241140|NCT00398398|"~     The combination of capecitabine and oxaliplatin as 'backbone' regimen, adding a newer~     biologic agent, cetuximab, is a reasonable strategy of further chemotherapy development in~     advanced gastric cancer, which is the investigators study rationale.~   "
241141|NCT00398385|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount~     of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any~     tumor cells that remain after surgery. It is not yet known whether giving chemotherapy before~     surgery is more effective than giving it after surgery in treating non-small cell lung~     cancer.~      PURPOSE: This randomized phase II trial is studying gemcitabine and cisplatin to compare how~     well they work when given before or after surgery in treating patients with stage I or stage~     II non-small cell lung cancer.~   "
241142|NCT00398372|"~     To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism~     of monoclonal antibody treatment by rituximab or epratuzumab will also be examined.~   "
241143|NCT00398359|"~     This project will apply the concepts from the Chronic Care Model to the problem of pediatric~     obesity and proposes: 1) to assess the effectiveness of teaching primary care providers (in~     diverse practice settings) to use specific communication strategies with parents of~     overweight and obese children to help them take steps with their child toward healthy~     behavior change; 2) to offer core components of an efficacious evidence-based pediatric~     obesity treatment within the pediatric primary care setting to determine if participating~     children will achieve clinically meaningful weight loss (assessed as weight and BMI~     percentile changes at the end of treatment and at a six month follow-up); and 3) to assess~     the ability of trained, behavioral psychologists to offer the treatment so that desired child~     outcomes are achieved. The primary project outcomes will include: 1) increase in~     self-reported physician confidence in use of counseling skills related to pediatric~     overweight; and 2) change in child's diet, physical activity, weight and BMI percentile at~     the end of treatment and at 6-month follow-up.~   "
241144|NCT00398333|"~     The purpose of this study is to determine if a nutritional supplement enriched in omega-3~     fatty acids is effective in improving the tolerance to chemotherapy treatment and improves~     quality of life.~   "
241145|NCT00398320|"~     Given the lack of other viable treatment options for metastatic neuroendocrine tumors,~     contrasted with our positive anecdotal experience, and the relative tolerability of the~     treatment regimen for colorectal cancer patients, we propose a single-institution phase II~     trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients~     with metastatic neuroendocrine tumors.~   "
241146|NCT00398307|"~     This is a Phase I, open-label study evaluating the PK of S-1 components and their metabolites~     in patients with advanced solid tumors and varying degrees of renal function. Patients will~     be stratified by baseline 24-hour creatinine clearance(CrCL) into 4 cohorts using the normal~     clearance formula:~      Group A: Control Group B:Mild renal dysfunction Group C:Moderate renal function and Group D:~     Severe renal dysfunction. Six patients will be enrolled into each cohort.~   "
241147|NCT00398294|"~     To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients~     with hypercholesterolemia.~   "
241148|NCT00398281|"~     RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate~     cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate~     cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more~     effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.~      PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy~     to see how well they find prostate cancer compared with a placebo and ultrasound-guided~     biopsy.~   "
241149|NCT00398268|"~     We create a follow-up study of Kirschner wire fixation of a unstable dislocated distal~     both-bone forearm fracture.~   "
241150|NCT00398255|"~     Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or~     fibromyalgia) and internet and email access were randomized to receive an internet-based~     arthritis self-management program (treatment group) or to continue with usual care (control~     group). Questionnaires measuring health indicators, health behaviors, self efficacy and~     health care utilization were administered at baseline, six months and one year after the~     course. It was hypothesized that those participating in the course would have better outcomes~     than the control group at six months and one year.~   "
241151|NCT00398242|"~     We create a randomized clinical trial between the treatment with above elbow armcast alone~     and the treatment of above elbow in combination with a short arm cast for stable midshaft~     both-bone forearm fractures.~   "
241152|NCT00398229|"~     The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the~     receptivity of the endometrium and the embryo quality.The effects of human chorionic~     gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was~     shown to up-regulate gene expression during the differentiation of human endometrial stromal~     cells into decidua. The aim of our study was to assess the benefit of hCG supplementation~     throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.~   "
241153|NCT00398216|"~     This study is to assess if DU176b is effective in prevention of blood clots following hip~     replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up~     visits.~   "
241154|NCT00398203|"~     To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard~     endoscope for the diagnosis and treatment of the small intestine.~   "
241155|NCT00398190|"~     The purpose of this project is to determine if a 3-session anti-smoking media literacy based~     intervention is more effective that a standard 3-session anti-smoking media literacy~     intervention at changing students' intention to smoke, actual smoking behavior, attitudes and~     norms regarding smoking, and level of media literacy.~   "
241156|NCT00398177|"~     The purpose of this study is to characterize the molecular and cell biology of the tumor~     cells in lymphoma.~   "
241158|NCT00398138|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system~     in different ways and stop cancer cells from growing. Giving vaccine therapy together with~     GM-CSF may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy and GM-CSF in~     treating patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung~     cancer, or mesothelioma.~   "
241159|NCT00398125|"~     To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected~     adults~   "
241160|NCT00398112|"~     This phase II trial is studying how well sunitinib works in treating patients with relapsed~     or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Sunitinib may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the cancer.~   "
241161|NCT00398099|"~     To collect clinical response data with the use of ertapenem in approved indications.~   "
241162|NCT00398086|"~     To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus~     Albumin-bound paclitaxel (ABI-007) in patients with advanced metastatic pancreatic cancer.~   "
241163|NCT00398073|"~     RATIONALE: Vaccines made from DNA may help the body build an effective immune response to~     kill tumor cells. Giving the vaccine in different ways may make a stronger immune response~     and kill more tumor cells.~      PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine~     therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage~     III, or stage IV melanoma.~   "
241164|NCT00398060|"~     Life-style change achieved in controlled experimental condition has been shown to prevent~     type 2 diabetes. The purpose of this study is to evaluate to what extent the life-style~     change can be achieved in a routine health care setting.~   "
241165|NCT00398047|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop~     the growth of abnormal cells, either by killing the cells or by stopping them from dividing.~     Colony-stimulating factors, such as darbepoetin alfa and G-CSF, may increase the number of~     red blood cells and white blood cells found in bone marrow or peripheral blood and may help~     the immune system recover from the side effects of chemotherapy. Giving azacitidine together~     with darbepoetin alfa and G-CSF may be an effective treatment for myelodysplastic syndromes.~      PURPOSE: This clinical trial is studying how well giving azacitidine together with~     darbepoetin alfa and G-CSF works in treating patients with myelodysplastic syndromes.~   "
241166|NCT00398034|"~     The purpose of this pilot study is to test the effects of testosterone replacement on pain,~     fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for~     chronic pain.~   "
241167|NCT00398021|"~     The purpose of this research is to see if a questionnaire on bowel habits can help identify~     children who will have constipation 12 months later.~   "
241168|NCT00398008|"~     A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance~     treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin~     and opium addicts in Iran.~   "
241169|NCT00397995|"~     We create a randomized clinical trial between above- and below elbow cast to find out what~     kind of treatment is optimal for undislocated both-bone distal forearm fractures.~   "
241170|NCT00397982|"~     This phase II trial is studying how well giving temsirolimus together with bevacizumab works~     in treating patients with stage III or stage IV malignant melanoma. Temsirolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for their growth. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Bevacizumab may also stop the growth of malignant~     melanoma by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab~     may kill more tumor cells.~   "
241171|NCT00397969|"~     RATIONALE: Receiving a reminder letter from their doctor may increase the frequency of~     colonoscopy in patients who have had a colorectal polyp removed.~      PURPOSE: This randomized clinical trial is studying how well a reminder letter from their~     doctor improves the frequency of colonoscopy in patients who have had a colorectal polyp~     removed.~   "
241172|NCT00397956|"~     To collect clinical response data with the use of ertapenem in community acquired sepsis.~   "
241173|NCT00397943|"~     This study will assess the safety and immunogenicity of 2 different formulations of~     tuberculosis vaccine GSK692342 in healthy adults.~   "
241174|NCT00397930|"~     RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.~      PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in~     cancer survivors.~   "
241175|NCT00397917|"~     The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception~     and during the first three months of pregnancy decreases the risk of having a child with~     cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have~     had previously child with an oral cleft.~   "
241176|NCT00397904|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth~     of tumor cells by blocking some of the enzymes needed for their growth. Drugs used in~     chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab~     together with cisplatin and irinotecan may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin~     and irinotecan works in treating patients with metastatic esophageal cancer, gastroesophageal~     junction cancer, or gastric cancer that did not respond to previous irinotecan and cisplatin.~   "
241177|NCT00397891|"~     Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational~     AAB-001 Vaccine in Japanese patients with Alzheimer's disease.~   "
241178|NCT00397878|"~     This phase II trial is studying how well AZD0530 works in treating patients with previously~     treated metastatic colon cancer or rectal cancer. AZD0530 may stop the growth of tumor cells~     by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell~     growth.~   "
241179|NCT00397865|"~     The purpose of the research is to find out if an educational booklet is helpful to families~     with overweight children. The educational booklet contains information for parents about~     nutritious eating, physical activity, and strategies for healthy living.~   "
241180|NCT00397852|"~     We create a randomized clinical trial between treatment with and without Kirschner wire~     fixation of a stable dislocated distal both-bone forearm fracture.~   "
241181|NCT00397839|"~     Male osteoporosis is a common and important clinical problem, associated with significant~     morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are~     osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given~     150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less~     frequent, once monthly, dosing is expected to improve patient's treatment adherence compared~     to a weekly dosing regimen.~   "
241182|NCT00397826|"~     To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients~     with hypercholesterolemia.~   "
241183|NCT00397813|"~     This phase II trial studies the side effects and best dose of total-body irradiation when~     given together with fludarabine phosphate followed by a donor peripheral stem cell transplant~     in treating patients with myelodysplastic syndromes (MDS) or myeloproliferative disorders~     (MPD). Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body~     irradiation before a donor peripheral blood stem cell transplant helps stop the growth of~     cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops~     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving cyclosporine and mycophenolate~     mofetil after the transplant may stop this from happening.~   "
241184|NCT00397800|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal~     antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry~     cancer-killing substances to them without harming normal cells. Giving rituximab and~     chemotherapy together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90~     ibritumomab tiuxetan when given together with rituximab, fludarabine, and cyclophosphamide~     and to see how well they work in treating patients with relapsed B-cell non-Hodgkin's~     lymphoma.~   "
241185|NCT00397787|"~     This phase II trial is studying how well sunitinib works in treating patients with metastatic~     pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may~     stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some~     of the enzymes needed for cell growth.~   "
241186|NCT00397774|"~     The project consists of two studies where we want to throw light on the importance of~     physical activity/exercise to maintain physical function among cancer patients whose disease~     is not responsive to curative treatment. Study I is a randomised intervention study where we~     want to study the effect of adjusted physical exercise compared to usual care. In study II~     our main aim is to validate different subjective and objective methods to measure physical~     functioning~   "
241187|NCT00397761|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized~     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed.~      PURPOSE: This phase II/III trial is studying how well giving capecitabine together with~     paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing~     surgery for stage II or stage III breast cancer.~   "
241188|NCT00397748|"~     This study will explore the brain in men with and without attention deficit hyperactivity~     disorder (ADHD). It will use positron emission tomography (PET) and magnetic resonance~     imaging (MRI) to study brain function and nerve cell communication involving phospholipids~     (fatty molecules that make up the covering of nerve cell fibers in the brain and are involved~     in communication between the cells). It will also look at how nerve cell communication is~     related to blood flow. In particular, the study will explore communication through the~     dopamine system, which is one of the main neurotransmitter systems in the brain involved in~     ADHD.~      Healthy men and men with ADHD between 18 and 55 years of age may be eligible for this study.~      Participants undergo the following procedures:~      <TAB>Medical history and psychiatric and medical evaluation, including blood and urine~     tests.~      <TAB>MRI scan. This test uses a strong magnetic field and radio waves to obtain images of~     the brain. The subject lies still on a table that slides into the scanner (a metal cylinder)~     during the scanning.~      <TAB>PET scanning. The subject lies on the scanner bed with his head held still using a~     special facemask. A catheter (plastic tube or needle) is placed in an artery to collect blood~     samples and in a vein to inject radioactive isotopes for measuring blood flow and~     phospholipid metabolism. Scans are done after an injection of a saline solution and again~     after injection of apomorphine, a medication that turns on dopamine receptors in the brain.~     The injections are given under the skin of the abdomen, about one and a half hours apart....~   "
241189|NCT00397735|"~     The aim of the study is to determine if N-acetylcysteine (a potent free radical scavenger)~     prevents the occurrence of adverse neonatal outcomes in preterm deliveries complicated by~     infection associated with preterm labor or preterm premature rupture of membranes (PPROM).~     The working hypothesis is that in pregnancies complicated by intra-amniotic infection or~     inflammation, N-acetylcysteine protects the fetus by preventing the development, or~     decreasing the intensity and/or progression of the fetal inflammatory syndrome.~   "
241190|NCT00397722|"~     GW876008 is a drug which may change mans reaction to stress, by decreasing the fear, physical~     and behavior symptoms that people with SocAD experience in social situations.~   "
244508|NCT00353613|"~     The primary research question is whether interventions to prevent caregiver and system errors~     will increase the proportion of laparotomy patients who receive recommended measures to~     prevent surgical site infections.~   "
241191|NCT00397709|"~     The objective of the study was to compare the compliance and the side effects of a short~     course to treatment of latent tuberculosis infection during 3 months(isoniazid plus~     rifampin)group I, with the standard course for 6 months(isoniazid)group II .Prospective,~     comparative, randomized and open trial of patients with positive TST and the suitable~     criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV~     infection. 105 patients were included. In Conclusion, a short course with isoniazid plus~     rifampin during 3 months shown better compliance with a lower percentage of abandonment that~     the course 6H. Tolerance is similar in the two courses.~   "
241192|NCT00397696|"~     The underlying goal of this study is to assess [123I] 5-IA and SPECT imaging as a tool to~     detect nicotinic receptor activity in the brain of PD patients. All study procedures will be~     conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging~     (MNI) in New Haven, CT. Approximately 10 patients with a diagnosis of PD without cognitive~     changes will be recruited to participate in this study. Patients will be eligible to~     participate if they have a diagnosis of PD of more than 2 years duration and have no~     significant cognitive changes.~   "
241193|NCT00397683|"~     The purpose of this study is to test MK0822 on disease activity in patients with~     osteoarthritis in the knee. Disease modifying activity of MK0822 will be assessed by~     measurements of knee cartilage using Magnetic Resonance Imaging (MRI) of the knee.~      This is an early phase trial and some specific protocol information is proprietary and not~     publicly available at this time. (Full information is available to trial participants).~   "
241194|NCT00397670|"~     The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel~     used with a contraceptive diaphragm.~   "
241195|NCT00397657|"~     Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of~     low-density lipoprotein (LDL-C) to provide greater protection from recurrent coronary heart~     disease (CHD) events. Thus, in August 2005, the guidelines for the treatment of lipid~     disorders (NCEP ATPIII) were revised to indicate that an LDL-C treatment goal of 70 mg/dL~     (revised from 100 mg/dL) was optional for patients with known CHD. In these same guidelines,~     low levels of high-density lipoprotein (HDL-C) are also suggested but not specifically~     proscribed as a target of therapy. Recently the ARBITER 2 trial has provided the first~     evidence of the potential of raising HDL-C with extended release niacin when added to statin~     monotherapy. However, whether this approach would be superior to a strategy in which lower~     concentrations of LDL-C are targeted is unknown.~      The purpose of ARBITER 6 - HALTS is to compare HDL and LDL-focused strategies of lipid~     treatments for their effects of atherosclerosis. This study is a prospective, randomized,~     open-label, blinded endpoint trial comparing treatment strategies of either HDL-raising~     therapies or LDL reduction for dyslipidemia on carotid atherosclerosis. Subjects with known~     atherosclerotic coronary or vascular disease or otherwise at high cardiovascular risk through~     the presence of a coronary risk equivalent who are currently being treated with a statin will~     be eligible. Subjects will be randomly assigned in an allocation-concealed fashion to open~     label treatment with either Ezetimibe 10 mg/d for additional LDL-lowering OR Extended-release~     niacin (1 gm/d, titrated to max tolerable dose up to 2 gm/d) for HDL improvement.~      The effects of these 2 different strategies of intensified lipid management on~     atherosclerosis will be assessed by the change in the carotid intima-media thickness, a~     validated surrogate endpoint. The data will help guide clinicians on the potential benefits~     of these lipid treatment strategies.~   "
241196|NCT00397644|"~     The objective of this study is to evaluate the impact and feasibility of a practice-based~     intervention on the discussion and referral of family psychosocial topics at well-child care~     visits at a medical home for low-income children.~   "
241197|NCT00397631|"~     A clinical study to evaluate the safety and efficacy of the initial combination therapy with~     sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with~     insulin or oral antihyperglycemic therapy.~   "
241198|NCT00397605|"~     Some people with bipolar disorder who use cannabis (marijuana) claim that it eases the~     symptoms of depression and mania. There are many chemicals (called cannabinoids) found in~     cannabis but two particular ones appear to have medicinal (therapeutic) effects. These two~     compounds are: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). These cannabinoids~     appear to have mood, anxiety, and sedative effects as well as have antipsychotic and~     anticonvulsant properties. This study will try to find out if these cannabinoids can be of~     benefit as an add-on treatment in bipolar disorder and what effects it has on thinking power~     and memory.~   "
241199|NCT00397592|"~     To assess the effect of short-term low-dose growth hormone therapy on the mobilization of~     endothelial progenitor cells from the bone marrow within a group of healthy adults.~   "
241200|NCT00397579|"~     RATIONALE: Combinations of biological substances in DT388IL3 fusion protein may be able to~     carry cancer killing substances directly to the cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of DT388IL3 fusion~     protein and to see how well it works in treating patients with acute myeloid leukemia or~     myelodysplastic syndromes.~   "
241201|NCT00397566|"~     The purpose of this clinical research study is to assess the safety, pharmacokinetics and~     pharmacodynamics of BMS-707035 in subjects infected with HIV-1~   "
241202|NCT00397553|"~     To provide local data on efficacy and safety of insulin glulisine in patients with Type 1~     Diabetes Mellitus receiving insulin glargine as basic insulin therapy~   "
241203|NCT00397540|"~     The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA~     level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs)~     related with HBV.~   "
241204|NCT00397527|"~     The purpose of this study is to demonstrate the safety of the gynecological formulation in~     normal and usual usage condition of Dermacyd Wipes~   "
241215|NCT00397384|"~     This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when~     given together with cetuximab and to see how well they work in treating patients with~     advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or~     colorectal cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking~     blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more~     tumor cells.~   "
241216|NCT00397358|"~     This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.~   "
241217|NCT00397345|"~     The purpose of this study is to investigate whether TroVax, when added to first line standard~     of care therapy, improves survival for patients with locally advanced or metastatic clear~     cell renal adenocarcinoma.~   "
241205|NCT00397514|"~     Malformations of the heart (congenital heart disease) are the most common congenital birth~     defects, occurring in about 1% of children. Each year, between 150-200 children will undergo~     open heart surgery at British Columbia Children's Hospital (BCCH) to repair the defect(s) in~     their heart. The abnormal structure of the heart or the open heart surgery may cause damage~     to the electrical system of the heart which can disturb the rhythm of the heart~     (arrhythmias), prolong recovery or be life-threatening. For this reason, temporary pacing~     wires are placed in the heart following surgery to ensure the heart rhythm is as normal as~     possible during the post-operative period (pacing). In recent years, scientists have~     recognized that pacing the heart from one area is not necessarily the same as pacing it from~     a different area. In fact, in some individuals with arrhythmias and poor heart function,~     pacing the heart from different areas can improve the pumping of the heart, resulting in~     better heart function. This form of treatment is called Cardiac Resynchronization Therapy~     (CRT) because it endeavours to optimize the pumping of the heart by changing the electrical~     activation of the heart. CRT has been used to a very limited extent in children. A few~     pediatric cardiologists have used CRT to help children who are in heart failure. We would~     like to determine whether pacing the heart from different areas after open heart surgery~     improves the child's heart function and aids his or her recovery.~   "
241206|NCT00397501|"~     RATIONALE: Osmotic blood-brain barrier disruption uses certain drugs, such as mannitol, to~     open the blood vessels around the brain and allow tumor-killing substances to be carried~     directly to the brain. Drugs used in chemotherapy, such as methotrexate and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Trastuzumab~     may also help methotrexate and carboplatin work better by making tumor cells more sensitive~     to the drugs. Giving osmotic blood-brain barrier disruption together with methotrexate,~     carboplatin, and trastuzumab may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of carboplatin when~     given together with methotrexate and trastuzumab after mannitol in treating women with breast~     cancer that has spread to the brain.~   "
241207|NCT00397488|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for their growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with~     progressive metastatic transitional cell cancer of the urothelium.~   "
241208|NCT00397475|"~     The purpose of this study is to determine the effect of a colecalciferol substitution in~     dialysis patients on bone metabolism and immune system~   "
241209|NCT00397462|"~     This project will test the efficacy of using a non-invasive neuromuscular stimulation on the~     plantar surface of the feet to prevent and/ or reverse bone loss in a sample of healthy adult~     women.~   "
241210|NCT00397449|"~     This is a randomized, open, dose-selection Phase 1 study. The study aims to evaluate the~     safety and immunogenicity of 3 doses (10,30 & 100 micrograms) of the GMZ2 hybrid (GLURP and~     MSP3) blood stage vaccine in healthy non-immune European adults. The vaccines will be~     administered with aluminum hydroxide as adjuvant. The safety and the tolerability of the~     vaccine will be assessed on the rate of solicited and unsolicited events/reactions related to~     the vaccine. The safety profile will include local and systemic reactions/events as well as~     the biological safety, based on a clinically significant change of the baseline value of the~     main biological criteria. The immunogenicity of the different formulation of the vaccine will~     be assessed on the level and the quality of circulating antibodies as well as the stimulation~     of the T-cell immune response.~   "
241211|NCT00397436|"~     The main focus of this pilot study is to construct a fairly complete protein profile of the~     epidermis. This will allow us to study how the epidermis responds to external stressors such~     as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we~     will be able to construct a fairly complete profile of different epidermal cells~     (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal~     and ultraviolet (UV) irradiated skin.~   "
241212|NCT00397423|"~     This study will examine the effectiveness of G-CSF in treating patients with amyotrophic~     lateral sclerosis (ALS) - a fatal neurological degenerative disease that causes adult-onset,~     progressive motor neurons loss in the spinal cord, brain stem and motor cortex. Patients~     develop progressive wasting and weakness of both upper and lower limbs, bulbar and~     respiratory muscles. Usually death from respiratory failure typically is within 3-5 years of~     diagnosis. Although there are various treatments for ALS, riluzole is the only approved~     treatment to delay the disease progression. G-CSF is an approved drug that is used to~     increase white blood cell counts. Moreover, G-CSF and its receptor are expressed by neurons.~     It acts anti-apoptosis by activating several protective pathways, stimulates neuronal~     differentiation of adult neural stem cells in the brain, and improves long-term recovery.~     G-CSF is a novel neurotrophic factor, and a highly attractive candidate for the treatment of~     neurodegenerative conditions such as ALS.~      Patients 18 to 65 years of age who have had mild to moderately severe ALS for 0.5 to 2 years~     of duration may be eligible for this study. Candidates will be screened with a medical~     history and possible review of medical records, physical examination, blood test, urine and~     stool analyses, electrocardiogram, electrophysiological examination, neurological imaging~     and, for women, a pregnancy test.~      Participants will have drug therapy according to randomized number. One group receives G-CSF~     while other group receives placebo. All of the participants receive riluzole treatment. For~     the procedure, patients are given a medication to lessen anxiety and any discomfort. Patients~     receive drug injections every 3 months for 5 days. The G-CSF dosage is 5μg/kg/day. Physical~     examination and interview, Appel ALS scale and ALS-Functional Rating Scale will be done in~     14, 28 days and 3, 6, 9, 12 months. Electrophysiological examination will be tested per 3~     months. Blood samples will be collected on treat 5, 14, 28 days and 3, 6, 9, 12 months.~   "
241213|NCT00397410|"~     The aim of this study is to compliance with and effect of soft and hard hip protectors in~     Norwegian nursing homes.~   "
241214|NCT00397397|"~     We wish to determine the best treatment for expulsion of lower ureteral stones. Which of the~     three major treatment protocols is the best treatment of conservative management of ureteral~     stones?~   "
241231|NCT00397163|"~     During coronary artery bypass graft surgery, injury occurs to the heart muscle. Some of this~     injury is due to the deprivation of oxygen and nutrients to the heart (a process called~     ischemia) during the surgery itself. The objective of this study is to examine whether remote~     ischaemic preconditioning (RIPC), in which the application of transient ischemia to the~     forearm and thigh (through the inflation of blood pressure cuffs placed on the right upper~     arm and upper thigh) may reduce the injury to the heart muscle sustained during cardiac~     surgery.~      The study hypothesis is: remote ischemic preconditioning will protect the heart and improve~     short-term clinical outcomes during coronary artery bypass graft surgery.~   "
241218|NCT00397332|"~     Alefacept (AMEVIVE®) is an immunosuppressive dimeric fusion protein that consists of the~     extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to~     the Fcof IgG1. Alefacept is produced by recombinant DNA technology in a Chinese Hamster Ovary~     (CHO) mammalian cell expression system. It was shown to interfere with lymphocyte activation.~     Alefacept was evaluated in two randomized, double-blind, placebo-controlled studies in adults~     with chronic plaque psoriasis. Each course consisted of once-weekly administration for 12~     weeks of placebo or alefacept. The response to alefacept was significantly better in both~     studies. In both studies, onset of response to alefacept treatment (defined as at least 50%~     reduction of baseline Psoriasis Area and Severity Index (PASI)) began 60 days after the start~     of therapy. With one course of therapy, the median duration of response (defined as~     maintenance of a 75% or greater reduction in PASI) was 3.5 months for alefacept treated~     patients and 1 month for placebo-treated patients. Most patients who had responded to either~     alefacept or placebo maintained a 50% or greater reduction in PASI through the 3-month~     observation period.~      Graft versus host disease (GVHD) is the most ominous side effect of allogenic stem cell~     transplantation (SCT). It causes severe inflammatory process, which is usually located to the~     skin, gut and liver. Treatment of GVHD consists of various immuno-suppressive and~     immuno-modulating drugs, including steroids, cyclosporine, tacrolimus, methotrexate etc.~     These drugs unfortunately can also cause severe immunologic failure that makes the patient~     prone to infection and malignancy, and other medication-specific side effects. In spite of~     this effect on the immune system, not all of the patients achieve control of GVHD, which~     usually rapidly leads to death. Despite the use of innovative immunosuppressive modalities,~     the prognosis of steroid resistant GVHD is usually poor. In the following study we will~     evaluate the effect of alefacept on steroid unresponsive cGVHD.~   "
241219|NCT00397319|"~     To evaluate specific markers of cardiovascular risk before and after growth hormone~     replacement therapy in a population of growth hormone deficient adults, as compared to an~     age, gender, and BMI-matched healthy population.~   "
241220|NCT00397306|"~     The purpose of this study is the evaluation of a bioimpedance method for determination of dry~     weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is~     investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO~     I-IV~   "
241221|NCT00397293|"~     This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of~     AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer~   "
241222|NCT00397280|"~     This study will investigate the response of immune cells (neutrophils, monocytes) to various~     signals in the test tube to determine how they sense the signals in the body and what~     substances they produce in response to them. It will determine how the cells may, under~     certain circumstances, contribute to inflammation, and will measure substances in the blood~     plasma (the liquid, non-cellular part of the blood) that might stimulate white blood cells,~     in order to understand how the blood responds to possible disease-related conditions.~      Healthy normal volunteers 18 years of age and older who weigh at least 110 pounds may be~     eligible for this study. Participants give about 320 milliliters (mL) of blood (about 1 1/3~     cups) or less at each donation. They donate no more than once every 8 weeks and no more than~     six times a year. On some occasions, less than 320 mL of blood may be drawn. The collected~     blood is separated into its components and specific cells are exposed to substances to~     examine their response....~   "
241223|NCT00397267|"~     We assume that the combination of systemic steroids and inhaled steroid in the first hour of~     treatment in the ER will decrease the admission rate and improve faster the pulmonary~     function.~      120 patients refferd to the ER due to asthma attack aged 18-60 with PFR < 60% 0o predicted~     will participate in the study after giving informed consent.~      The usual treatment in the ER is inhalation of Beta 2 short acting and I.V solumedrol 120 mg~     . The study group will recieve in addition 3 inhalation of Budesonide 1000 microgram each~     during the first hour.~      The controlled group will recieve Nacl 0.9% PFR will be followed 0 30 60 120 min.~   "
241224|NCT00397254|"~     The primary objective of this study is to evaluate a clinical limit (CL) of rizatriptan (9~     rizatriptan 10mg Orally Disintegrating Tablet (ODT) per month) versus (vs.) a formulary limit~     (FL) of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of~     migraine per month.~   "
241225|NCT00397241|"~     The primary objective of this crossover trial is to compare the 3-month mean 24-hour~     intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC)~     given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening~     and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and~     latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are~     insufficiently controlled with latanoprost monotherapy.~   "
241226|NCT00397228|"~     After a screening evaluation including baseline clinical laboratory testing, a physical and~     neurological evaluation, subjects will be asked to undergo an injection of ALTROPANE®~     followed by up to 60 minutes of serial dynamic imaging. Subjects will undergo a second~     injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging within 2-6~     weeks of the injection 1.~   "
241227|NCT00397215|"~     The present study is designed to evaluate the immunogenicity and safety of a single or double~     dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a~     two-administration schedule (21 days apart) in adults over 60 years of age. The persistence~     of influenza antibodies will also be evaluated 24 months after vaccination.~   "
241228|NCT00397202|"~     1. Purpose: To compare the use of the menstrual cup The DivaCupTM  to a menstrual~          strategy using tampons as the primary method of menstrual flow management using~          indicators of user-satisfaction, urinary tract infection, vaginal irritation, cost and~          waste.~        2. Hypothesis: The The DivaCupTM will have similar rates of user-satisfaction, urinary~          tract infection, and vaginal irritation as a menstrual strategy using tampons as the~          primary method of menstrual flow management but will likely be more reasonable in terms~          of cost and will generate less waste.~   "
241229|NCT00397189|"~     This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment~     period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged~     18-80 with melatonin deficiency.~   "
241230|NCT00397176|"~     Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release~     (DVS SR) in healthy Japanese female subjects.~   "
241267|NCT00396682|"~     It has been shown that patients with advanced HCC have an increased frequency of CD4+CD25+~     regulatory T cells. These cells might suppress tumor-specific immune responses.~     Cyclophosphamide has been shown to reduce the frequency of CD4+CD25+ regulatory T cells. The~     aim of this study is to test if the treatment with cyclophosphamide leads to a decrease in~     the frequency of CD4+CD25+ regulatory T cells and to increase tumor specific immune responses~     in patients with advanced HCC.~   "
241232|NCT00397150|"~     The objective of the project is to develop and test an intervention to promote exclusive~     breastfeeding (EBF), to assess its impact on infant health in African contexts where a high~     prevalence of HIV is a barrier, and to strengthen the evidence base regarding the optimal~     duration for EBF.~      Promotion of EBF is the most effective child health intervention currently feasible for~     implementation at the population level in low-income countries. It can lower infant mortality~     by 13%, and by an additional 2% were it not for the fact that breastfeeding transmits HIV.~     Only recently proven to be possible in hot and even dry climates, EBF without even offering~     water is still little appreciated by mothers or supported by health workers. EBF rates are~     especially low in Africa but the potential for rapid implementation may be high. A few~     studies elsewhere suggest that peer counselling can often achieve dramatic increases. Thus~     the investigators will run the first randomised trial to develop and test models for applying~     this approach in four African countries and to quantify health benefits, cost-effectiveness,~     and implications for the health care system.~      While experts realize that the HIV threat ought not to present much of a biological~     constraint to promoting EBF, in heavily affected countries it does represent a cultural~     constraint. Overcoming this will require the development of a safe and effective means of~     promoting EBF that is HIV-sensitive by taking into account the need to minimise postnatal HIV~     transmission.~      Another scientific constraint to the promotion of exclusive breastfeeding for six months, as~     recommended by the World Health Organization (WHO), is uncertainty about its impact on the~     micronutrient status of infants. In a substudy, the investigators will carefully follow~     markers of infant micronutrient status to see how they vary by feeding pattern, including~     EBF, for a longer period than has been examined previously.~   "
241233|NCT00397137|"~     The aim of this study is to determine the role of stapled anopexy in the treatment of~     haemorrhoids by comparing it to the current gold standard treatment, which is excisional~     haemorrhoidectomy.~   "
241234|NCT00397124|"~     the aim of this study is to measure brain metabolism in patients with lung cancer.FDG uptake~     in the brain in patients with malignant tumors will be compared to the amount of tracer~     activity found in patients who have benign pulmonary process. if differences between the~     brain uptake of FDG in the two groups will be found, further assessment will be performed in~     order to evaluate if such differences could be attributed and specifically localized to the~     brain regions innervated by the vagus~   "
241235|NCT00397111|"~     This study is intended to help develop new MRI imaging techniques for studying mood and~     anxiety disorders. Researchers believe that depression and anxiety disorders may cause~     structural and functional changes in the brain. This study will optimize the way MRI scans~     are collected to look at brain structure and examine how the brain behaves while subjects~     perform particular tasks.~      Healthy normal subjects between 18 and 50 years of age who have never had a major psychiatric~     disorder and who have no first-degree relatives with mood disorders may be eligible for this~     study. Candidates are screened by phone with questions about their psychiatric and medical~     history, current emotional state and sleep pattern, and family history of psychiatric~     disorders. Candidates who pass the preliminary screening then undergo additional screening~     interviews and laboratory tests.~      Participants undergo magnetic resonance imaging (MRI) and neuropsychological testing, as~     follows:~      <TAB>MRI scans: Subjects are asked to participate in an MRI study on one of several scanners~     to measure blood flow in the brain, concentrations of certain chemicals in the brain, or~     magnetic properties of the brain. MRI uses a strong magnet and radio waves to obtain pictures~     of the brain. The subject lies still on a narrow bed with a metal coil close to the head. For~     this study, subjects may be asked to wear a special coil on the neck to help measure blood~     flow. They may be asked to watch a screen presenting images or to do a task in which they~     respond to pictures or sounds and may be asked to return for additional scans.~      <TAB>Neuropsychological testing: Subjects may undergo tests of cognitive performance. Often,~     people with mood disorders have subtle changes in performance on these tests that allow~     researchers to pinpoint where brain abnormalities occur. Before the tests can be used in~     patients, they must be validated by using healthy subjects. These tests are presented either~     orally, in written form, or on a computer.~   "
241236|NCT00397098|"~     The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID)~     compared to placebo in the prevention of relapse of anxiety, in patients with Generalized~     Anxiety Disorder improved after 12 weeks of treatment with SR58611A.~      The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo~     over a 24 to 52-week treatment period.~      The secondary objective is to assess the safety and tolerability of SR58611A in patients with~     GAD.~   "
241237|NCT00397072|"~     The purpose of this single arm phase II study is to evaluate safety and efficacy of ZK 219477~     in the treatment of temozolomide pre-treated, recurrent GBM patients.~   "
241238|NCT00397059|"~     To study the impact of CYP2C19 polymorphism on escitalopram pharmacokinetics and~     pharmacodynamics measured as changes in pupil diameter~   "
241239|NCT00397046|"~     The purpose of this study is to assess the tolerability and safety of HKI-272, and to~     determine the maximum dose that can safety be given. The secondary purpose of this study is~     to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is~     effective for the treatment of advanced solid tumors.~   "
241240|NCT00397033|"~     The purpose of this study is to measure the effectiveness and assess the safety of two~     dosages of the antipsychotic paliperidone extended-release (ER) in patients who are~     experiencing an acute episode of schizoaffective disorder.~   "
241241|NCT00397020|"~     The primary objective of this study is to compare the efficacy and tolerability of quetiapine~     versus divalproex extended-release administered in a rapid oral loading fashion in the~     treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses~     will be tested:~      Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in~     the symptomatic control of mania or mixed mania~      Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements~     in symptoms of mania sooner than quetiapine~      Hypothesis 3: divalproex extended-release may produce significantly less sedation~   "
241242|NCT00397007|"~     The study aims to develop and to evaluate a psychophysiological intervention for distressing~     chronic tinnitus. Therefore 100 people suffering from chronic tinnitus are randomly assigned~     to either an intervention-group, receiving 12 sessions of a psychophysiological oriented~     intervention, or to a waiting-list-group, who are waiting for a comparable time period.~     Afterwards, patients of the waiting-list-group also receive intervention. The effects of the~     intervention on severity, distress and perceived loudness of the tinnitus as well as on other~     psychological variables like depression or self-efficacy are evaluated through comparing the~     results of the intervention group with those of the waiting-list-group.~      Additionally the psychophysiological reactivity under different stress-conditions is measured~     before and after intervention or waiting. Therefore the activity of the muscles of head and~     shoulders (EMG) as well as the skin temperature and skin conductance are measured. It is~     hypothesized that patients with stronger psychophysiological reactivity benefit more from an~     psychophysiological intervention.~   "
241243|NCT00396994|"~     The purpose of this study is to determine if daily low magnitude, high frequency whole body~     vibration can improve bone density in seniors.~   "
241407|NCT00394836|"~     A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human~     Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to~     Rituximab as Monotherapy or in Combination With Chemotherapy~   "
241244|NCT00396981|"~     Primary Objectives:~        -  To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used~          for the treatment of intracranial saccular aneurysms. TAR is defined as clinically~          relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture~          and/or death from an unknown cause.~        -  To correlate defined angiographic endpoints with TAR rates and assess their predictive~          value, thereby providing a framework to establish clinically relevant endpoints for~          future studies.~      Secondary Objectives:~        -  To evaluate device characteristics, incidence and severity of device-related adverse~          events, including death, neurological deterioration and changes in functional abilities.~        -  To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the~          treatment of intracranial saccular aneurysms.~        -  To explore an experimental, quantitative and volumetric endpoint and correlate these~          with existing qualitative assessments.~   "
241245|NCT00396968|"~     AMD3100 given in combination with busulfan, fludarabine (and thymoglobulin (ATG) for~     unrelated or HLA nonidentical donors) preparative regimen in patients with acute myelogenous~     leukemia (AML) / myelodysplastic syndromes (MDS).~      This study aims to determine if in AML and MDS patients there is a reduction of malignant~     cells and enhanced elimination of the leukemia as assessed by progression free survival.~     Secondary goals will be to assess effects on engraftment, graft versus host disease (GVHD)~     and immune reconstitution.~   "
241246|NCT00396955|"~     Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active~     osteoarthritis (OA) of the knee.~      Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among~     dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers~     related to clinical responses. To assess PLA-695 exposure-response relationship on PD,~     efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.~   "
241247|NCT00396942|"~     This study will compare brain changes in people with Parkinson's disease with those of normal~     control subjects while they learn motor skills. People with Parkinson's disease sometimes~     have trouble learning new skills, but it is not known why. This study will use repetitive~     transcranial magnetic stimulation (rTMS), nerve conduction studies, and~     electroencephaolography (EEG) to look for differences in the way the brain changes with~     learning in people with Parkinson's disease.~      Healthy normal volunteers and people with Parkinson's disease who are between 21 and 80 years~     of age may be eligible for this study. Participants undergo the following procedures in five~     visits to the NIH Clinical Center:~      Visit 1~      Medical and neurological examination.~      Visit 2~      Motor training. Participants perform a pinching movement once every other second, timed to a~     metronome, during rTMS. For TMS, a wire coil is held on the subject's scalp. A brief~     electrical current is passed through the coil, creating a magnetic pulse that stimulates the~     brain. The subject hears a click and may feel a pulling sensation on the skin under the coil.~     There may be a twitch in the muscles of the face, arm or leg. rTMS involves repeated magnetic~     pulses delivered in short bursts of impulses.~      Visits 3 and 4~      Brain physiology studies using rTMS, nerve conduction studies (electrical nerve stimulation)~     and EEG. A nerve at the subject's wrist is stimulated with electrical impulses to measure the~     speed with which nerves conduct electrical impulses and the strength of the connection~     between the nerve and the muscle. rTMS is performed for 20 minutes. The EEG measures the~     electrical activity of the brain (brain waves). For this test, electrodes (metal discs) are~     placed on the scalp with a conductive gel and the brain waves are recorded while the subject~     moves his or her thumb briskly for 20 minutes.~      Visit 5~      Subjects undergo rTMS for 20 minutes and have an EEG.~   "
241248|NCT00396929|"~     The aim of the study is to examine the efficacy of Paclitaxel injection after a stent~     implantation in patients with stenosis in native coronary arteries to prevent restenosis in~     comparision with two admitted therapies.~   "
241249|NCT00396916|"~     The purpose of the present study is to assess the role of hybrid PET/CT imaging diagnosis of~     active malignancy in cancer patients with rising tumor markers after treatment and in the~     diagnosis of primary tumor in patients with metastatic cancer of unknown origin. The clinical~     impact of PET/CT in the management and treatment of these two groups of cancer patients will~     be evaluated~   "
241250|NCT00396903|"~     During the insertion of epidural catheters several complications can occur, including~     transient paraesthesia and inadvertent venous cannulation.~      Reported incidences for paraesthesia vary widely between about 0.2% and 50% in different~     articles, depending on the catheter (catheter material, soft-tipped or firm-tipped catheter),~     the applied technique (lumbar or thoracic epidural anesthesia, depth of catheter insertion),~     the approach (midline or paramedian) and the included patients (obstetrical or~     non-obstetrical). Furthermore, the inconsistent definition of paraesthesia makes it~     difficult to compare the results of different studies. Paraesthesia are not supposed to lead~     to permanent neurological sequelea, but are unpleasant and perturbing sensations for the~     patient.~      For inadvertent venous cannulation during epidural catheter placement, incidences between 1%~     and 14% have been reported. As for the paraesthesia rate, catheter material, technique,~     approach and included patients are determinants for the incidence of vessel puncture.~      Main objective of this study is to determine the incidence of paraesthesia with this~     catheter.~      Secondary objectives are to record~        -  the frequency of inadvertent venous cannulation~        -  difficulties involved in insertion and removal of the catheter~        -  data on additional complications~        -  data for the evaluation of handling characteristics~   "
241251|NCT00396890|"~     This study will determine whether stimulation of the right side of the brain with repetitive~     transcranial magnetic stimulation (rTMS) followed by stimulation of the left side with theta~     burst stimulation (TBS) can temporarily change brain activity and improve hand movements in~     subjects more than has recently been achieved with rTMS alone.~      For rTMS, a wire coil is held on the patient's scalp. A brief electrical current is passed~     through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a~     click and may feel a pulling sensation on the skin under the coil. There may be a twitch in~     the muscles of the face, arm or leg. The subject may be asked to tense certain muscles~     slightly or perform other simple actions. The effect of TMS on the muscles is detected with~     small metal disk electrodes taped to the skin of the arms or legs. This study uses two kinds~     of rTMS. In one (Hz rTMS), magnetic pulses are given once per second for a period of 20~     minutes; in the other (TBS), a series of pulses are given in bursts, each lasting 2 seconds,~     for a period of 3 minutes.~      Healthy normal volunteers between 18 and 55 years of age may be eligible for this study.~     Participants undergo the following procedures during three visits to the NIH Clinical Center:~      Visit 1:~      Participants receive either real or sham rTMS applied on the right side of the brain followed~     by real or sham TBS applied on the left side of the brain. In addition, subjects undergo the~     following:~       Pinch force: Subjects press a wedged instrument between the thumb and index finger as hard~     as they can during several trials every 10 seconds.~       Speed tapping: Subjects press a key on a computer keyboard as quickly as possible for 10~     seconds, repeated for several trials.~       Simple reaction time: Subjects respond as quickly as possible to a go signal presented on~     a computer monitor by performing a quick wrist movement.~       Electromyography: Subjects' muscle activity is recorded using electrodes (small metal~     disks) filled with conductive gel and taped to the skin over the muscle.~      Visits 2 and 3~      Visit 2 is scheduled for one day after visit 1, and visit 3 is one week after visit 1.~     Participants do not have brain stimulation during these two visits, but they have TMS~     measurements, behavioral measurements, and electromyography (EMG) to see if the brain~     stimulation done during the first visit is still present after a period of time.~      At all three visits, participants comp...~   "
241404|NCT00394875|"~     To determine whether the management of type 2 diabetes mellitus (DM2) can be transferred from~     an internist to a supervised nurse specialized in diabetes (NSD) with a comparable quality of~     clinical care, health care costs, health related quality of life (HRQOL), and patient~     satisfaction.~   "
241252|NCT00396877|"~     Contemporary management of cyanotic congenital heart disease includes three stages of~     surgery. Incidence of shunt thrombosis and death between the two first stages of palliation~     remains important.~      The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day~     for the reduction of all cause mortality and shunt related morbidity in neonates or infants~     with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt~     (e.g. modified Blalock Taussig Shunt [BTS]).~      The secondary objective was to assess the safety of Clopidogrel in the study population.~   "
241253|NCT00396864|"~     Multicenter, open-label study of NPI-0052 in patients with advanced solid tumor malignancies~     or refractory lymphoma whose disease had progressed after treatment with standard, approved~     therapies that included 2 stages. The initial stage involved dose escalation to an MTD and~     determination of a recommended Phase 2 dose. The second stage comprised an expansion cohort~     at the recommended Phase 2 dose.~   "
241254|NCT00396851|"~     The study plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with~     metformin in patients with type 2 diabetes~   "
241255|NCT00396838|"~     Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in~     infants. Despite the short- and long-term adverse effects of pain, there are no guidelines~     for the reduction of such pain. Previous studies evaluated different treatment modalities;~     however, in most of them, pain response was assessed by subjective measures.~      Aims of study: 1. To characterize the pain response of infants by using a computerized~     analysis of the ECG. 2. To compare six different methods of pain reduction during heel~     lancing in newborns.~      Methods: The time, geometric and frequency domains of the infants' ECG will be computed~     during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups:~     breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying~     with a pacifier and lying while getting a glucose solution. The differences in pain response~     to these six treatment modalities will be assessed and compared to the infants' length of~     cry, and scoring of the infants' behavioral response.~   "
241256|NCT00396825|"~     The purpose of this Phase II SBIR study is a) to complete the adaptation begun in Phase I of~     the ten skill modules of the Williams LifeSkills Video (WLV) for use by persons who are~     caregivers for a relative with Alzheimer's Disease (AD) or other dementia, b) to script and~     produce the complete Caregiver LifeSkills Video (CLV) and c) to conduct a randomized clinical~     trial of the completed CLV to document benefits in terms of reduced psychosocial distress,~     reduced biomarkers of stress and improved well being.~   "
241257|NCT00396812|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling,~     pain, stiffness, damage, and ultimately loss of joint function. Scientists estimate that~     about 1.3 million people (0.6 percent) of the U.S. adult population have RA. Current~     therapies target the immune system early in the disease process before joint damage occurs,~     and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents.~     Rituximab is a disease-modifying antirheumatic drug (DMARD) recently approved by the FDA for~     use in combination with MTX for treatment of moderately to severely active RA in patients who~     have had an inadequate response to TNF-blocking agents, in an effort to try to slow the~     course of the disease. This study will examine the effects of rituximab on the immune~     response and disease activity in participants with early RA who have not been treated with~     any disease-modifying agent. In addition, the safety and tolerability of rituximab in this~     population will be examined.~   "
241258|NCT00396799|"~     The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated~     estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated~     estrogens tablets produced using a new manufacturing process~   "
241259|NCT00396786|"~     The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as~     a tablet, are safe and can help prevent blood clots forming after a hip replacement~     operation. Patients undergoing hip replacement surgery are at risk of developing blood clots.~     To reduce this risk treatment to prevent clots forming is routinely given. The current~     treatments can include injections under the skin or other treatments that need frequent blood~     tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which~     are easier to give and need less monitoring.~   "
241260|NCT00396773|"~     Electrocoagulation effect of neonatal brain waves after cesarean section~   "
241261|NCT00396760|"~     The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid~     equally influence bleeding tendency and transfusion requirement in patients undergoing first~     time cardiac procedures with a low risk of increased postoperative bleeding.Only patients~     undergoing first time CABG or first time aortic valve replacement are included in this study.~   "
241262|NCT00396747|"~     The purpose of the study is to compare the effects of methotrexate (MTX) alone or in~     combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected~     synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.~   "
241263|NCT00396734|"~     The overall aim of this project is to use an advanced brain imaging technique, PET, in order~     to monitor the progress of pharmacotherapy with modafinil or topiramate for cocaine~     dependence in methadone-maintained patients who use cocaine in addition. Comparisons will be~     made within the cocaine dependent methadone maintained subjects, between the start and end of~     treatment, and between the two medications. This is the first systematic research study of~     pharmacological treatment for cocaine dependence in Israel. This study is of major clinical~     use, with implications for the treatment of cocaine dependence in poly-drug abusers in~     Israel. Successful pharmacotherapy for cocaine dependence is expected in reduction in~     cue-induced subjective craving and in glucose metabolism in brain areas elicited by cocaine~     craving. Metabolic activity in regions that are activated by craving should be correlated~     with dopamine DRD2 receptor occupancy in all patients.~   "
241264|NCT00396721|"~     The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus~     oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.~   "
241265|NCT00396708|"~     This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic~     rehabilitation system for increasing functional independence and long term rehabilitation of~     chronic stroke victims with a hemiparetic upper extremity.~   "
241266|NCT00396695|"~     Traumatic events may lead to strong emotional episodic memories common in Post- Traumatic~     Stress Disorder(PTSD). Intense affect may inhibit efficacy of glutamatergic neurotransmission~     in two particular areas of the limbic system that have been implicated in the processing of~     emotionally charged memories: the amygdala and the hippocampus(1,2).~      Dysfunction of glutamatergic neurotransmission is associated with disbalance of long-term~     potentiation (LTP) and long-term depression (LTD)- two underlying mechanisms that cooperate~     to achieve synaptic plasticity and its expressations- learning and memory(3). LTP- the long~     lasting enhancement of synaptic function includes changes in the amount of neurotransmitter~     glutamate released into a synapse, changes in the levels of key proteins in synapses, protein~     phosphorylation and changes the density of receptors on their synaptic membranes. LTD is the~     inverse of LTP, a long lasting reduction in synaptic transmission (4). Interactions among the~     different forms of plasticity underlie different forms of memories. Normally these mechanisms~     are balanced.~      In the current literature there is data that a class I major histocompatibility complex (MHC~     class I) molecules, known to be important for immune responses to antigen, are expressed also~     by neurons that undergo activity-dependence, long-term structural and synaptic modifications~     (5). The brain produces its own immune molecules, the proteins MHC class I and CD3-zeta (a~     component of receptors for MHC class I). In the immune system, the two proteins act as part~     of a lock and key system to recognize and get rid of the body’s foreign invaders. The~     CD3-zeta polypeptide is component of the T cell antigen receptor (TCR) which contribute to~     its efficient cell surface expression and account for part of its transducing capability (6).~      In the brain, they may be part of a signaling system that recognizes and eliminates~     inappropriate neural connections. Expression of MHC class I is regulated by the naturally~     occurring electrical activity, and sensitive to both natural and pathological changes in the~     activity. Electrical activity of neurons drives to an establishment of the final pattern of~     connection. Changes in the strength of individual synapses such as potention and depression~     leads to stabilization and withdrawal, respectively, of the affected connections. There are~     data, that in mice with deficiency of MHC class I and CD3-zeta the LTP in the hippocampus is~     enhanced significantly and LTD is absent. Thus, MHC class I is crucial for translating~     activity into changes in synaptic strength and neuronal connectivity in vivo. He required for~     normal activity dependent potentiation, depression, removal of inappropriate connection and~     responding to injury in the CNS (6).~      Glutamate receptors play critical roles in LTP/LTD mechanisms. Some researchers consider that~     a key role in pathogenesis of PTSD is being played by excessive excitation of NMDA-receptors~     in limbic system structures (1). The existing data allows to assume, that equation of~     plasticity mechanisms depends on mutual relations between the MHC class I and glutamate~     receptors.~      T-cells, like neurons, express high levels of glutamate receptors that are identical to the~     brain glutamate receptors. Presence of ionotropic and metabotropic glutamate receptors in~     membranes of lymphocytes makes them sensitive to the same alarm molecules which operate~     neuronal activity. Glutamate by itself triggers several T-cell activation which differs~     quantitatively or qualitatively from that ones triggered by “classical’ T-cell activators~     like antigens(7). There are data about influence of T cell receptor-CD3 complex- on the~     expression of T-cells glutamate receptors (8). It is possible, that the key roles in this~     function play CD3-zeta.~   "
241405|NCT00394862|"~     Investigate the efficacy of weekly versus daily of folic acid supplementation on improving~     folate, vitamin B12,~   "
241268|NCT00396669|"~     Dopamine (DA) plays a critical role in nicotine (and other) addiction and this drug is known~     to release DA in brain areas mediating reward and motivational processes. Although imaging~     studies show that release of DA follows smoking, little is known regarding how common genetic~     polymorphisms for three genes associated in some studies with smoking (dopamine D2 receptor,~     dopamine and serotonin transporter) interact with smoking status and modulate individual~     differences in nicotine-induced DA release and dopamine receptor occupancy, in vivo. The~     current proposal combines brain imaging and genomics ('imaging genomics') towards partially~     unraveling the complex relationship between smoking phenotype and common polymorphisms.~     Understanding whether genetic factors contribute to inter-individual variability in smoking~     is crucial for interpreting imaging results in the context of disease pathology. We~     hypothesize that a model of vulnerability to addiction based on interactions between~     genotype, receptor and transporter availability and in vivo nicotine-induced DA release will~     elucidate some of the fundamental neurochemical and neurogenetic circuits underlying~     addiction.~   "
241269|NCT00396656|"~     This study evaluated the effect of valsartan on small vessel blood flow in patients with~     mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.~   "
241270|NCT00396643|"~     Early intervention in psychosis might be associated with better outcomes. However,~     intervention in the pre-psychotic phase has been questioned as, using current criteria, only~     20-50% of individuals classified as prodromal develop a psychotic disorder within a 1-2 years~     period. Treatment agents investigated in the pre-psychotic phase of schizophrenia and other~     psychotic disorders should, therefore, not have major side effects. This proposal~     investigates omega-3 fatty acids (1.2 gramm per day eicosapentaenoic acid/docosahexaenoic~     acid;EPA/DHA) as a beneficial and possible preventive therapeutic agent in young people at~     ultra high-risk for developing a psychotic disorder.~   "
241271|NCT00396630|"~     The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus)~     vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving~     placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,~     Sep 2007.~   "
241272|NCT00396617|"~     The benefits of this new material, as demonstrated in animal studies and preliminary studies~     in man, could provide the answer to problems encountered by surgeons in the field of~     phonatory implants. This novel application is a step towards resolving the very real problems~     which still exist in the field today. The functional concept, which will allow better control~     over integrating implants in tissue, should also, it is hoped, favour cellular colonization,~     thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified~     potential complications linked to the use of silicone-only implants (with or without a~     surface coating), like leakage around the prosthesis (by cellular colonization), and so~     reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid~     trauma to the peri-prosthetic tissues by repeated interventions~   "
241273|NCT00396604|"~     The study is designed to obtain safety and efficacy data on three dose levels of indacaterol~     when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of~     treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg,~     indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a~     washout-period of 1 week.~   "
241274|NCT00396591|"~     The primary objective of this study was to compare the time between paracenteses before and~     after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in~     ovarian cancer participants with symptomatic malignant ascites.~      The secondary objectives were to further assess efficacy and safety of Aflibercept treatment,~     and the exploratory objectives were to assess pharmacokinetics, immunogenicity and~     health-related quality of life.~   "
241275|NCT00396578|"~     The purpose of this study was to determine the effect of aerosolized antibiotics on~     respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized~     antibiotics , which achieve high drug concentrations in the airway, would more effectively~     treat respiratory infection, decrease the need for systemic antibiotics and decrease~     antibiotic resistance.~   "
241276|NCT00396565|"~     The purpose of this study is to evaluate the effectiveness and safety of Extended Release~     Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in~     patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.~   "
241277|NCT00396552|"~     Obsessive-compulsive disorder (OCD) is a severe psychiatric condition with only limited~     response to current first-line treatments, comprising pharmacotherapy and~     cognitive-behavioural therapy. Repetitive transcranial magnetic stimulation (rTMS) is a~     relatively new technique which has shown great promise in the treatment of refractory mood~     disorders, and schizophrenia, by alteration of brain activity. Previous work has demonstrated~     altered cortical excitability in OCD and preliminary studies have suggested that rTMS may~     have therapeutic potential in OCD. This pilot study will investigate the effectiveness of~     rTMS for treatment-refractory OCD, and establish appropriate treatment parameters. In~     addition, mechanisms whereby rTMS exerts its therapeutic effect will be explored using TMS to~     evaluate cortical inhibition and measures of cognitive biases and processing.~   "
241278|NCT00396539|"~     Oral malodor is a common condition. In most cases this condition results from the proteolytic~     activity of anaerobic oral bacteria. These bacteria produce volatile sulfide compounds which~     are fowl smelling and are felt during exhalation and speech. the aim of the present study is~     to examine a simple method of detecting these bacteria in samples taken from the oral cavity~     of oral malodor patients.~   "
241290|NCT00396383|"~     This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and~     well tolerated in multiple myeloma (MM) patients. In addition, this study determines if~     plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for~     transplantation in MM patients. The minimum number of CD34+ cells to collect is 2*10^6 CD34+~     cells/kg and the target is ≧4*10^6 CD34+ cells/kg. Success of transplant engraftment will be~     measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT)~     engraftment. Durability of transplant will be assessed for a minimum of one year.~   "
241406|NCT00394849|"~     The purpose of this study is to determine if closing the tonsil fossa after tonsillectomy~     leads to less pain and bleeding risk than leaving it open to heal by secondary intention.~   "
241279|NCT00396526|"~     Background: With documented rise in bacterial resistance in vitro to co-trimoxazole, there is~     a need to document in vivo effectiveness of the drug in treatment of non-severe pneumonia in~     the community setting.~      Setting: The study will be conducted in 18 rural primary health center (PHC) in 9 districts~     in India near Lucknow, Nagpur, New Delhi, Mumbai, Chennai, Trivandrum, Vellore, Chandigarh~     and Bhopal.~      Design: The unit of randomization will be the PHC. The recruited children will be followed up~     on days 4, 6 and 13-15 to assess primary and secondary outcome measures.~      Hypothesis: The primary hypothesis is that the clinical failure rate with use of either oral~     amoxycillin for three days or five days co-trimoxazole is similar.~      Intervention: Oral Co-trimoxazole (8mg/kg/day trimithoprim) twice a day for five days vs.~     oral amoxycillin (20 mg/kg/day) thrice a day for three days.~      Main objective: To compare the proportion of children aged 2 to 59 months presenting with~     non-severe pneumonia with or without wheeze, who do achieve clinical cure on day 6 on~     treatment with 5 days oral co-trimoxazole and 3 day oral amoxycillin, respectively.~      Main outcomes measures: Clinical cure on day 6; clinical failure between day 1-6; clinical~     relapse between day 7-15.~      Inclusion criteria: Children aged 2-59 months with non-severe pneumonia based on WHO criteria~     of respiratory rate above the age specific cut-off with or without wheeze, accessible to~     follow up, whose guardians give written informed consent.~      Exclusion criteria: Children with severe disease, other infectious disease requiring~     antibiotic treatment, documented use of antibiotic for the last 48 hours, three or more~     episodes of wheezing in a year, diagnosed asthmatics, known immunodeficiency disease, acute~     or chronic organic disease, history of hospitalization within last 15 days, measles within~     last one month, drug allergy, refusal to give consent, prior enrollment in the study.~      Sample size: Has been calculated to test the null hypothesis. There will be 1100 children in~     each arm. Thus each PHC is required to recruit a minimum of 122 cases within one year.~      Policy relevance: The findings of the study can effect the ARI management policy. If the~     current study proves that three day amoxycillin is clinically as effective as five day~     co-trimoxazole and with the well documented evidence of rising resistance to co-trimoxazole,~     short course amoxycillin may become the first line treatment for non-severe pneumonia Time~     line: 18 months. Pilot in March 2003, enrollments from April 2003, Interim analysis Nov.~     2003, DMC meet Dec. 2003, Data cleaning June 2004, DMC meet July 2004, Manuscript writing~     Aug.2004.~   "
241280|NCT00396513|"~     The purpose of this study is to compare effects of statins (simvastatin) and metformin on~     clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic~     (lipids, markers of systemic inflammation), and endothelial function parameters in women with~     polycystic ovary syndrome (PCOS).~   "
241281|NCT00396500|"~     Background. More than a third of the world’s population is infected with intestinal~     nematodes. A majority of these infections occur in children. Current control approaches~     emphasise treatment of school age children, and there is a lack of information on the effects~     of deworming preschool childrenSetting: Within the Integrated Child Development System (ICDS)~     infrastructure in urban Lucknow (UP), IndiaDesign: Open Labeled randomised trialHypothesis:~     Our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose~     in syrup, by the existing health care delivery system would be a practicable way to achieve~     mass deworming of preschool children and this might result in an improvement in weight gain~     of preschool childrenIntervention One group will receive usual health care by the existing~     health care staff, which included six monthly administration of Vitamin A concentrate. The~     other group will receive, in addition, 400 mg of albendazole (Zentel, Smith Kline & Beecham)~     in 10 ml syrup form. Five such doses will be given at six monthly intervals for 2 years.Main~     objective: To assess the impact of 6 monthly deworming on weight and height gain at the end~     of 2 years in children aged 1 to 5 years of age Main outcomes measures: Weight gain in 2~     yearsInclusion criteria: Children 1 to 5 years, whose guardians give written informed~     consent. Exclusion criteria: Those not consentingSample size: Sample size was calculated for~     a continuous outcome. For a standardized effect size of 0.1, with a power of 80% and an alpha~     level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000~     children will be included in each arm.~   "
241282|NCT00396487|"~     To compare the response rate of single agent chemotherapy in advanced colorectal cancer given~     as standard treatment versus tailored treatment in a randomised phase III trial.~   "
241283|NCT00396474|"~     The purpose of this study is to demonstrate that insulin sensitivity is not different between~     growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort~     of subjects matched by gender and body mass index (BMI) who are not treated with growth~     hormone (GH) and who remain short at final height.~   "
241284|NCT00396461|"~     This study aims to analyse the effect of two total parenteral nutrition diets with lipid~     emulsions of different compositions on the incidence of nosocomial infection in critical~     patients. One diet will contain an MCT/LCT emulsion concentrated to 20% (50:50 ratio) and the~     other will comprise an MCT/LCT/fish oil emulsion (50:40:10 ratio). The secondary objective of~     this study is to analyse mortality in hospital and up to 6 months of discharge.~   "
241285|NCT00396448|"~     The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in~     obese adults~   "
241286|NCT00396435|"~     The purpose of this study is to evaluate, on renal transplanted patients with CGD, the effect~     of two levels of haemoglobin on quality of life at 6 months and the speed of progression of~     renal function degradation at 24 months.~      This study will recruit 140 patients in 21 centers in France.~   "
241287|NCT00396422|"~     The primary objective of the study is to evaluate the safety and tolerability of 50, 100,~     200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with plaque psoriasis~   "
241288|NCT00396409|"~     Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy~     (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid~     seasonal allergic rhinoconjunctivitis.~   "
241289|NCT00396396|"~     The purpose of this study is to investigate the exact role of Acetylcysteine (Mucomyst) in~     altering creatinine clearance. Prior studies have shown the protective effects of~     Acetylcysteine on contrast-induced renal dysfunction. In these studies, Acetylcysteine~     lowered the incidence of serum creatinine elevation after administration of radiographic~     contrast agents. Not only was the increase in serum creatinine prevented, the studies also~     demonstrated a significant increase in creatinine clearance after administration of the~     agent. These prior studies did not evaluate if the increase in creatinine clearance was~     indeed from a protective benefit of Acetylcysteine in preserving the GFR versus simply~     increasing the proximal tubular creatinine secretion without actually affecting the GFR. We~     propose an experiment to help support our hypothesis that Acetylcysteine increases creatinine~     clearance via an increase in proximal tubular secretion of creatinine.~   "
241305|NCT00396188|"~     The purpose of this study is to determine the ability of a proprietary software screening~     tool to discriminate normal corneas (front surface of the eye) from previously diagnosed~     corneal conditions (diseases/surgeries/pathologies) and to determine the repeatabiltity and~     reproducibility of the Atlas II corneal topographer in normal human corneas.~   "
241408|NCT00394823|"~     The purpose of this study is to assess the impact of supportive measures on the drug~     adherence of patients with essential hypertension~   "
241291|NCT00396370|"~     This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against~     tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both~     methods produces greater results. BCG vaccine and/or placebo (substance containing no~     medication) will be given by mouth and/or by injection into the skin. This study, conducted~     at Saint Louis University, will enroll 60 (up to 80) healthy volunteers, 18-40 years old, who~     are negative for a TB test (QuantiFERON®-Gold) and human immunodeficiency virus (HIV). Study~     procedures will include a physical exam; review of TB exposure history and medical history;~     collection of multiple samples of blood, urine, stool, tears, and nose fluid; and skin and~     blood tests for TB. Volunteers may participate for about 24 months.~   "
241292|NCT00396357|"~     This study is designed to evaluate the efficacy and safety of vildagliptin in combination~     with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.~   "
241293|NCT00396344|"~     The purpose of the research is to study a common and dangerous medical condition called~     'septic shock' that often occurs in critically ill patients. In order to learn about septic~     shock in humans, we will administer a substance called 'endotoxin' to participants in this~     study. Endotoxin causes a temporary period of inflammation in the human body, a brief~     'virtual' infection. This is an established method for the investigation of inflammation~     properties. We are interested in how the natural hormone, cortisol, can affect the human~     response to endotoxin. We know that when cortisol is given at the same time as endotoxin it~     can decrease the inflammation that occurs due to endotoxin. In this study we will test~     whether or not cortisol, when given the day before the endotoxin, will work to change the~     inflammation that occurs due to endotoxin. In order to test this, two-thirds of the study~     participants will receive cortisol on the day before they receive the endotoxin and one-third~     of the study participants will receive a placebo (no medication) before the endotoxin.~   "
241294|NCT00396331|"~     This study evaluates the safety, efficacy, and pharmacokinetics (PK) of plerixafor given in~     addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood~     stem cells (PBSCs) for autologous transplantation in patients who would benefit from an~     autologous stem cell transplant but have failed previous collections or collection attempts~     with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional~     therapy including cytokines, chemotherapy and cytokines and bone marrow harvests.~      The only change to standard of care of a mobilization regimen that includes G-CSF is the~     addition of a dose of AMD3100 (plerixafor) on the evening prior to each day of apheresis.~      Efficacy outcomes include quantification of CD34+ cells in the apheresis product and~     assessment of successful polymorphonuclear leukocyte (PMN) and platelet (PLT) engraftment~     after transplantation. PK outcomes include analysis of repeated doses of plerixafor.~   "
241295|NCT00396318|"~     This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the~     United States and Canada. 251 adult and pediatric patients with dysfunctional central venous~     catheters (CVCs) were enrolled in the study and treated with one or two doses of~     tenecteplase.~   "
241296|NCT00396305|"~     This research study is being done because influenza (flu) affects many people each year~     throughout the world. The elderly and those with chronic health problems are at greater risk~     for complications from the flu. The purpose of this research study is to evaluate vaccination~     strategies in the elderly and others receiving the influenza vaccination in order to increase~     protection. All subjects will receive the flu vaccine as an injection in the muscle of the~     upper arm. Participants may receive a booster [an extra dose of vaccine or placebo (inactive~     substance)] shot. Study participants will include healthy adult volunteers, ages 21-40,~     60-89, or 90 years and older. Subjects will be involved in study related procedures for 6~     months.~   "
241297|NCT00396292|"~     This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who~     display postpartum anemia.~   "
241298|NCT00396279|"~     To determine how safe and effective denosumab is in treating patients with giant cell tumor~     of bone.~   "
241299|NCT00396266|"~     This study evaluates the safety and efficacy of plerixafor given in addition to~     granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells~     (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and~     multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating~     CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor~     (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN)~     engraftment after transplantation. Data from this protocol will assist in the determination~     of the dosing schedule for future studies.~   "
241300|NCT00396253|"~     This was a Phase III, open-label study conducted at 44 centers in the United States, Canada,~     and Puerto Rico. 223 subjects who required hemodialysis (HD) and had a dysfunctional HD~     catheter were enrolled in the study.~   "
241301|NCT00396240|"~     24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin~     plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment~     goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.~   "
241302|NCT00396227|"~     This study is designed to evaluate, in a primary care setting, the safety and efficacy of~     vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients~     with type 2 diabetes inadequately controlled by metformin alone.~   "
241303|NCT00396214|"~     The primary objective of the study is to evaluate changes in weight short and long term with~     bifeprunox and quetiapine. Study participation for the subject is 57 weeks.~   "
241304|NCT00396201|"~     Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive~     chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the~     inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic~     (PK) study. The only changes to the standard of care is the addition of plerixafor to a~     granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to~     apheresis. The purpose of this protocol is to determine the proportion of participants who~     reach a target number of CD34+ stem cells (≥5*10^6 cells/kg) after hematopoietic stem cell~     mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.~   "
241306|NCT00396175|"~     A clinical study to collect additional data in order to characterize the reduction in PSA~     with finasteride 1 mg, and its reversibility in men with androgenetic alopecia between the~     ages of 40 to 60 years.~   "
241307|NCT00396162|"~     Chronic sinusitis is reported to be one of the most widespread disorders in the United~     States. It can be caused by a variety of reasons such as allergy, infection and/or defects in~     T-cells which help regulate immune function. Medication and other costs related to treatment~     of nasal and sinus infections are estimated to be more than $60 million annually putting a~     considerable strain on the economy of health care.~      Probiotics are live microorganisms that are normally present in the gut of a healthy~     individual. They are also known as friendly bacteria and have been used to help maintain~     the normal functioning of the immune system. They are safe and are commercially available in~     the form of yoghurt, sachets, chewable tablets or flavored capsules. Since a number of nasal~     and sinus disorders are related to allergy and improper functioning of the immune system, we~     hypothesize that regular use of probiotics may help improve chronic nasal and sinus symptoms~     by boosting immune responses.~      The project we propose is novel because it would be the first study evaluating the usefulness~     of probiotics for the larger population having chronic sinusitis rather than those having~     only allergic symptoms. We aim to assess whether regular use of probiotics will help improve~     symptoms of chronic sinusitis and will have a greater effect than placebo in this regard.~   "
241308|NCT00396149|"~     To investigate the safety and tolerability of successive single rising doses of SLIT in~     subjects with allergic rhinitis and to investigate the safety and tolerability of multi high~     dose regimens of SLIT in subjects with allergic rhinitis.~   "
241309|NCT00396136|"~     The objective of this post approval registry is to confirm the long-term safety and~     effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in~     conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The~     Corox OTW Steroid LV Lead is capable of providing permanent pacing therapy to the left~     ventricle in a CRT-D system. The following are the specific objectives to be evaluated during~     this post-approval registry:~        -  Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing~        -  Safety of the COROX OTW Steroid LV pacing lead~   "
241310|NCT00396123|"~     Humans have cells in their blood stream called endothelial progenitor cells or EPCs. These~     are thought to be important in keeping blood vessels healthy. People with chronic kidney~     disease (CKD) have low numbers of these cells. People with cardiovascular (heart and blood~     vessel) disease also have low numbers. Patients with CKD have more cardiovascular disease~     then any other group.Erythropoietin is a hormone made by the kidneys. It is essential for~     making red blood cells and also activates EPCs. It is low in people with kidney disease.~      As part of your regular medical care for correcting your low red blood cell count, you will~     be receiving a medication that acts like erythropoietin. It is called darbepoetin.~      The purpose of this study is to see if darbepoetin treatment affects EPC numbers and~     function.~   "
241311|NCT00396110|"~     In this study the effect of the switch to rosuvastatin from another statin (fluvastatin,~     pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without~     evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET)~     representing daily practice. Primary end points analysis was the percentage of patients~     reaching the target of LDL-C < 3.2 mmol/l. Secondary outcomes were the changes of LDL-C,~     HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.~   "
241312|NCT00396097|"~     To demonstrate that an individualized, formula-based Genotropin regimen for children with~     Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th~     percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to~     explore treatment efficiency over four years of two formula-based dose regimens (sub-arms)~     compared to standard treatment~   "
241313|NCT00396084|"~     This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause~     tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin,~     and moxifloxacin. All are approved by the Brazilian health authorities to treat infections~     caused by germs other than TB. Seventy human immunodeficiency virus (HIV)-negative adults,~     aged 18-65 years, who have been newly diagnosed with pulmonary (lung) TB, will participate in~     this study. Study volunteers will be given one of the 4 study drugs or a comparison~     antibiotic, Isoniazid, which has been used around the world as a standard of care treatment~     for TB. Volunteers will stay in the hospital for 10 days and be given a study antibiotic 7 of~     those days. Blood and saliva samples will be taken. Six weeks later, volunteers will return~     for a final health check. All volunteers will receive 6 months of standard tuberculosis~     treatment.~   "
241314|NCT00396071|"~     This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin~     secretion to improve the incretin effect in patients with type 2 diabetes.~   "
241315|NCT00396058|"~     The purpose of the study is to determine whether methylphenidate facilitates so called~     short-term plasticity as measures with transcranial magnetic stimulation, in patients with~     stroke.~   "
241316|NCT00396045|"~     The purpose of this study is to evaluate the safety and efficacy of the association of~     Melphalan/Prednisone/Revlimid (MPR) as induction treatment for newly diagnosed myeloma~     patients over age 65 or those under 65 years who refuse or are not eligible for high dose~     therapy. This association might further increase the response rate achieved by the standard~     oral MP regimen.~   "
241317|NCT00396032|"~     This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37~     centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD)~     and had a dysfunctional HD catheter were enrolled in the study.~   "
241356|NCT00395512|"~     The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and~     pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with~     diet and exercise alone.~   "
241357|NCT00395499|"~     The purpose of this research is to: (1) examine the secrection of risperidone (RIS)~     (Risperdal) and its metabolite, 9-OH-RIS, in saliva, (2) determine the concentration ratio of~     RIS and 9-OH-RIS between plasma and saliva, and (3) compare the rate of decline in~     concentration of RIS and 9-OH-RIS in saliva and plasma by measurements at timed intervals~     during a single dosing interval.~   "
241358|NCT00395486|"~     The primary objective of this study is to compare the effect of rosuvastatin 10mg with~     atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with~     metabolic syndrome.~   "
253760|NCT00229827|"~     The purpose of this study is to determine the optimal timing for repair of left-to-right~     shunt lesions such as ventricular septal defects and atrioventricular canals.~   "
241318|NCT00396019|"~     This study is for slow growing tumors called plexiform neurofibromas (PNF) which are a~     relatively common problem in people with neurofibromatosis type 1 (NF1). These tumors are~     benign but as they grow, they can become disfiguring as well as disabling or even life~     threatening. They often cause pain, difficulty using arms or legs because of spinal cord~     compression, and/or nerve damage. At present, the only available therapy for plexiform~     neurofibromas is to try to surgically remove as much of the tumor as is possible. Because~     these tumors grow into the surrounding areas, total surgical resection is often impossible.~     Most tumors will re-grow after surgery if the entire tumor cannot be removed. To date, other~     treatments including chemotherapy and radiotherapy have not been able to shrink these tumors.~      Interferon is a drug that is used for different types of tumors as well as for hepatitis. It~     has been used in the treatment of plexiform neurofibromas (PNF) with some subjects showing~     improvement in symptoms and/or a decrease in the size of the tumor. Most subjects had no~     further growth of their tumor while on the PEG-Intron. The drug used in this study is PEG~     (pegylated)-Intron. PEG-Intron is a long acting form of interferon which keeps the drug from~     being broken down in the body for a longer period of time and potentially could be more~     effective than the short-acting interferon. PEG-Intron has been approved by the Food and Drug~     Administration (FDA) for the treatment of Hepatitis C.~      The goals of this study are:~        1. To determine how your child's plexiform neurofibroma responds to PEG-Intron when given~          weekly.~        2. To determine the side effects of PEG-Intron when given weekly to participants with~          plexiform neurofibromas.~        3. To evaluate a new method of measuring changes in the size of tumors called volume~          analysis. This method measures the entire volume of a tumor in three dimensions. The~          standard method of measuring tumors uses only the length and/or width of the tumor. By~          studying the different ways of measuring tumors the investigators hope to be able to~          determine which method is the most accurate and useful.~   "
241319|NCT00396006|"~     The purpose of this study is to evaluate the effects of weekly augmentation therapy with~     ARALAST Fraction IV-1 (Fr IV-1) on epithelial lining fluid (ELF) alpha 1-proteinase inhibitor~     levels and other ELF analytes and to assess the safety of the treatment. Eligible subjects~     with a diagnosis of severe congenital alpha 1-antitrypsin deficiency will receive 8~     consecutive weekly treatments with 60 mg/kg/week of functional ARALAST Fr IV-1 administered~     intravenously. The efficacy and safety assessments will include two bronchoscopies with~     bronchoalveolar lavage on study initiation and on study termination and multiple imaging and~     laboratory safety assessments. Each subject will participate for a minimum of 12 weeks.~   "
241320|NCT00395993|"~     This study compares of the safety and efficacy of intravenous iron vs oral iron in the~     treatment of anemia secondary to heavy uterine bleeding~   "
241321|NCT00395980|"~     Using healthy volunteers, participants will lay on an operating room table in various~     positions employed during kidney surgery. Using a pressure sensor mat, we hope to determine~     which areas of the body are subject to higher pressures. Using padding devices (foam, gel,~     water mattress)which are currently used in the operating room will be employed and~     measurements will be taken to determine which padding material and configurations is optimal~     to reduce the pressure to those body parts at risk for excessive pressure subject during~     laparoscopic surgery.~   "
241322|NCT00395967|"~     This Phase 2 study was designed to assess the safety and hematological activity of AMD3100~     (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were~     predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. Patients~     with NHL and MM were eligible to enter the study if they had undergone cyto-reductive~     chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion~     criteria.~      The purpose of this protocol was to determine whether plerixafor in combination with~     Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of~     peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low~     after treatment with G-CSF alone, whether it was safe, and whether transplantation with the~     apheresis product was successful, as measured by time to engraftment of polymorphonuclear~     leukocytes (PMNs) and platelets (PLTs).~   "
241323|NCT00395954|"~     The hypothesis underlying this study is that failure to recognise the role of lactose~     intolerance among patients has led to inappropriate dietary advice and treatment with drugs~     that contain lactose as a filler. These failures exacerbate symptoms and lead to the~     unnecessary use of immune suppressant drugs.~      This study will identify the threshold at which symptoms of lactose intolerance develop, to~     provide appropriate advice and treatment in the management of patients.~   "
241324|NCT00395941|"~     Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid~     control of moderate to severe chronic plaque type psoriasis.~   "
241325|NCT00395928|"~     Impairment of relaxation, the early phase of ventricular diastole is the first stage of heart~     diastolic dysfunction. Left ventricular diastolic function can be determined noninvasively by~     Echo- Doppler – derived mitral valve flow velocities. The addition of pulmonary venous flow~     pattern enables more accurate assessment of left ventricle diastolic function. The role of~     the right ventricle in haemodynamic function of the heart is now emphasized. The right~     ventricle diastolic function can be assess by recording the Doppler tricuspid valve flow~     pattern. Impaired LV diastolic function usually precedes systolic dysfunction and may cause~     clinical signs of congestive heart failure. Cigarette smoking is one of the major risk~     factors for cardiovascular diseases. The aim of the study was to assess left and right~     ventricular diastolic function in healthy, young and slim smokers before and after smoking~     one cigarette.~      Echocardiographic examination: before and after smoking one cigarette Echocardiographic~     evaluation of mitral valve flow, pulmonary venous flow, tricuspid valve flow and hepatic vein~     flow to assess diastolic function of ventricles.~   "
241326|NCT00395915|"~     The principal clinical question to be answered by CHAT (Clozapine Haloperidol Aripiprazole~     Trial) is the relative efficacy and tolerability of combination treatment with clozapine plus~     aripiprazole compared to combination treatment with clozapine plus haloperidol in patients~     with an incomplete response to treatment with clozapine over an appropriate period of time.~   "
241327|NCT00395902|"~     Retrospective chart review to gather information on Sensipar patterns of use and effects on~     biochemical parameters in renal transplant recipients~   "
241328|NCT00395889|"~     The purpose of this study is to compare participation in physical activities in daily life~     and functional outcomes of lung transplant recipients attending a six-month multicomponent~     rehabilitation program including exercise training against others receiving only instructions~     on how to increase their participation in physical activities in daily life.~   "
241329|NCT00395876|"~     This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted~     at 24 centers in the United States and Canada. 100 adult and pediatric patients with~     dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to~     receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).~   "
241330|NCT00395863|"~     The purpose of this study is to evaluate whether Multihance is superior to Magnevist in terms~     of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for~     the visualization of brain disease.~   "
241331|NCT00395850|"~     This study examines the influence of dopamine beta-hydroxylase enzyme activity on the~     clinical efficacy of the novel pharmacotherapy, disulfiram, for treating cocaine dependence~     in cocaine-dependent patients, some of whom are opioid dependent and maintained on an~     FDA-approved opioid agonist. Cocaine dependence as well as co-morbid cocaine and~     opioid-dependence is associated with more public health issues and poorer treatment prognosis~     when admitted to methadone maintenance. Yet no effective pharmacotherapies have been~     developed to treat cocaine dependence to date. One novel pharmacotherapy, disulfiram, has~     shown some promise as a treatment for this disorder in several clinical trials at a dose of~     250 mg/day or more (e.g., Carroll et al., 1998, 2004). This 14-week, randomized, double blind~     clinical trial will provide treatment for up to160 cocaine-dependent individuals, aged 18-65~     years. Participants who are opioid dependent will be stabilized on methadone maintenance~     during the first 2 weeks and baseline cocaine use will be assessed; participants will be~     stratified by DBH genotype and randomly assigned to receive disulfiram at either 0, 250, 375~     or 500 mg/day. During induction onto methadone for opioid dependent individuals, participants~     are administered increasing doses of methadone on a daily basis until maintenance doses are~     attained. At the beginning of week 3, participants receive methadone, if relevant, plus~     disulfiram or placebo disulfiram according to their randomized assignments, and are~     maintained on study medication(s) through week 14. At the end of the study, participants will~     undergo detoxification from the opioid agonist, if relevant, and active/placebo medication~     over a 4- to 6-week period. All participants receive weekly 1-hour psychotherapy (Cognitive~     Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy~     and who will receive ongoing supervision. Participants undergo a delay discounting session~     during week 1. The primary outcomes will be retention, reduction in opioid and cocaine use,~     as assessed by self-report and confirmed by thrice-weekly urinalyses, and disulfiram~     side-effects profile. Secondary outcomes will include reductions in other illicit drug and~     alcohol use, and improvements in psychosocial functioning. The prognostic relevance of~     genotype at the DBH locus, DβH activity, etc., on response to disulfiram will be examined.~   "
241332|NCT00395837|"~     To assess the impact of lifestylel changes upon measures of wellness and aging, in particular~     weight change, fitness measures, and cognitive performance. The hypothesis was that aerobic~     exercise would improve mental performance and measures of fitness.~   "
241333|NCT00395824|"~     Hemodialysis causes contact activation of the coagulation pathway (1). For this reason,~     unfractionated or low molecular weight heparins are administered in daily practice to prevent~     thrombosis of the dialyzer and blood circuit, but the dose commonly used causes systemic~     anticoagulation. This can cause serious complications in patients with high risk of bleeding.~     Regional and low-dose heparinization, use of prostacycline, regional citrate anticoagulation~     (RCA), and high-flow-rate hemodialysis without anticoagulation have been shown to reduce~     bleeding complications. Each of these methods, however, is characterized by its own technical~     difficulties, limitations, or complications.~      The present study aimed to compare the efficacy and safety of heparin-coated~     polyacrylonitrile membranes (AN69ST) and regional citrate anticoagulation in hemodialysis~     patients at risk of bleeding~   "
241334|NCT00395811|"~     The purpose of this study is to determine whether intracoronary transfer of autologous bone~     marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion,~     and finally resulting in improved systolic and diastolic left ventricular function in~     patients with myocardial infarction.~      50 patients with stable left ventricle function will - with six months interval - receive two~     treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional~     myocardial territories and Coronary Artery Bypass Graft (CABG).~   "
241335|NCT00395798|"~     Objectives:The purpose of this study is to determine if use of nech collar (stiff or~     soft)will improve the possibility to obtain painrelief in patients with cervical radicular~     pain. We will compare short term (six weeks and three months) and long term ( one year)~     effect of six weeks use of neck collar (stiff or soft)together with neck school information~     with neck school information alone.~   "
241336|NCT00395785|"~     The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™~     System when used during a stent placement in a blockage within the carotid artery in patients~     considered to be at high risk for complications from surgical endarterectomy.~   "
241337|NCT00395772|"~     The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the~     safety and effectiveness of this new drug with the standard way of treatment of deep vein~     thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new~     events of thrombosis and pulmonary embolism and bleeding risk.~   "
241338|NCT00395759|"~     The purpose of this study is to investigate how the addition of a new artificial tear product~     when applied to the tear layer affects contrast sensitivity and optical aberrations over~     time. We will also determine if there are any adverse effects associated with drop~     instillation.~   "
241339|NCT00395746|"~     This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic~     control of liraglutide in combination with sulphonylurea agent (SU) compared to SU~     monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2~     diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a~     randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.~   "
241340|NCT00395733|"~     The purpose of this study is to determine if the contrast agent is effective and safe in the~     Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.~   "
241341|NCT00395720|"~     This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who~     are infected with HIV. In phase I studies, a single vaccination with MVA85A, when~     administered at a dose of 5 x 10^7pfu intradermally, has been shown to be safe in both~     mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected~     individuals. Additionally, 5 x 10^7 pfu MVA containing HIV antigens administered twice, 4~     weeks apart, in HIV positive individuals, is safe. We will use 5 x 107 pfu MVA85A~     intradermally in this study. Subjects will be identified from HIV clinics in the Oxford~     Radcliffe Hospitals NHS Trust and also from Swindon and Marlborough NHS Trust and St. Mary's~     Hospital NHS Trust if our recruitment targets are not met.~   "
241342|NCT00395707|"~     The primary objective of this study is to determine the safety & efficacy of ranibizumab for~     the treatment of retinal angiomatous proliferation secondary to age related macular~     degeneration.~   "
241343|NCT00395694|"~     To evaluate safety information of BW430C when administered using the lower starting doses and~     slower dose escalations as recommended Global Data Sheet~   "
241359|NCT00395473|"~     In the context of australian general practice, to determine the efficacy and safety of~     ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol~     receiving statin 40mg or more.~   "
241360|NCT00395460|"~     The purpose of this study is to determine if the contrast agent is effective and safe in the~     Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.~   "
241344|NCT00395681|"~     Rationale: The extreme increase of obesity in the last years had led to this study. There is~     no consensus about how to anaesthetise morbidly obese patients. The amounts of narcotics~     given vary widely and rather depend on the anaesthetist than on the pharmacokinetics and~     dynamics in the morbidly obese patient. Reason for this is that it is not clear in what~     extend the pharmacokinetics and dynamics are affected in the morbidly obese patient.~      Objective: The study is performed in order to develop a population pharmacokinetic and~     pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in~     the morbidly obese patient (BMI > 40). A covariate analysis will be performed in order to~     account for variability in pharmacokinetic and/or pharmacodynamic parameters. This model will~     take into account patient and procedure bound covariates. The results will be used to develop~     individualised dosing schemes of Propofol when used for induction and maintenance of~     anaesthesia in morbidly obese patients.~      Study design: A randomised, therapeutic and non-invasive study.~      Study population: Morbidly obese patients with a Body Mass Index > 40 undergoing laparoscopic~     banding or gastric bypass surgery, 18-60 year old.~      Intervention (if applicable): Patients will be randomised into two groups, one group will be~     given 200 milligrams of Propofol and the other group will be given 350 milligrams of~     Propofol. During the induction of anaesthesia with Propofol over 60 seconds, the patient is~     asked to count in order to measure time to induction of anaesthesia. During and following~     anaesthesia a maximum of 50 ml of blood will be taken from an indwelling arterial line. Depth~     of sedation will be measured using non-invasive Bispectral Index (target 40-60) and other~     standard measures (heart frequency and blood pressure).~      Main study parameters/endpoints: Primary endpoints: pharmacokinetic parameters; clearance,~     intercompartmental clearance, volume of central compartment and volume of peripheral~     compartment.~      Secondary endpoints: pharmacodynamic parameters; time to induction of anaesthesia (stop~     counting, eyelash reflex, quality of anaesthesia, corresponding dose required for induction~     of anaesthesia for both induction doses), EC50 using BIS, required doses of Propofol during~     maintenance of anaesthesia, wake-up time.~      Nature and extent of the burden and risks associated with participation benefit and group~     relatedness: A maximum amount of 50 milliliters of blood will be sampled from an indwelling~     arterial line. The patient will be asked to count slowly during induction of anaesthesia.~     Both induction doses of 200 and 350 milligrams are currently used standard induction doses~     for morbidly obese patients.~   "
241345|NCT00395668|"~     The purpose of this study is to investigate if electromagnetic radiation from TETRA handset~     can influence cognitive function and the well-being of healthy adults. Furthermore, the~     purpose is to provide any special information about the subjects which can cause the possible~     reactions.~   "
241346|NCT00395655|"~     Aberrant DNA methylation and histone deacetylation participate in cancer development and~     progression, as epigenetic alterations are common to breast cancer, in this phase II study,~     the demethylating hydralazine plus the HDAC inhibitor magnesium valproate will be added to~     neoadjuvant doxorubicin and cyclophosphamide in locally advanced breast cancer to assess~     their safety and biological efficacy.~   "
241347|NCT00395642|"~     This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK~     Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the~     follow-up treatment of patients implanted with a Cardiac Resynchronization Therapy~     Implantable Cardioverter Defibrillator (CRT-D). The feasibility study is designed to plan and~     define endpoints for a larger randomized study. The study will assess the HM-parameter trends~     correlation with daily weight and blood pressure changes. The patient compliance rate of the~     two different telemonitoring systems (HM & ETM) will also be evaluated.~   "
241348|NCT00395629|"~     Brief Summary: This study was designed to explore a safe dose and characterize the~     preliminary safety and efficacy of ICL670 in adult patients with previously documented~     history of homozygous C282Y.~   "
241349|NCT00395616|"~     Humeral lateral epicondylitis or tennis elbow is a common painful elbow disorder. The cause~     of tennis elbow is the chronic overload of bone-tendon junction. High prevalence of tennis~     elbow has a direct impact on the workplace productivity and quality of life. Steroid~     injection is the very few methods proved to have short-term efficacy in tennis elbow~     treatment, but it has potential adverse effects like tendon rupture. Temporary paralysis of~     muscle after botulinum toxin injection may reduce the physical demands and facilitate the~     normal repair mechanism during recovery. Preliminary studies suggested that botulinum toxin~     injection is effective in treating tennis elbow. The objective of this study is to compare~     the effects of botulinum toxin injection with corticosteroid injection in tennis elbow~     treatment.~   "
241350|NCT00395603|"~     To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in~     reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.~   "
241351|NCT00395590|"~     Obstructive sleep apnea is a common sleep disorder. It is known to be related with increased~     body mass, abdominal obesity, insulin resistance and hypertension. It is currently believed~     to be a feature of the metabolic syndrome. Other features of the metabolic syndrome-such as~     insulin resistace were found related to inflammation and inflammatory cytokines. Several~     polymorphisms in the genes that encode interleukin 6,inteleukin 10 and TNF-alpha have~     significant influence on the amounts of cytokine production. we thus hypothesize that~     polymorphisms related to increased pruduction are more common in subjects with OSA than in~     matched controls~   "
241352|NCT00395577|"~     The purpose of this study is to assess the safety and effects of VX-702 in subjects with~     moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.~   "
241353|NCT00395564|"~     The investigator intends to review retrospective de-identified data of patients who have had~     Open, Laparoscopic, Ureteroscopic or Percutaneous Urologic Surgery.~   "
241354|NCT00395551|"~     The purpose of this study is to determine whether ranibizumab is effective in the treatment~     of choroidal neovascularization secondary to causes other then wet macular-degeneration.~   "
241355|NCT00395538|"~     Hypoparathyroidism is a rare condition associated with a low level of parathyroid hormone~     (PTH) in the blood. Hypoparathyroidism can be genetic and show up in childhood, or it can~     occur later in life. If it occurs later, it is usually due to damage or removal of the~     parathyroid glands during neck surgery. PTH helps control the amount of calcium in blood,~     kidneys, and bones. Low levels of calcium in the blood can cause a person to feel sick. It~     can cause cramping or tingling in the hands, feet, or other parts of the body. A very low~     blood calcium can cause fainting or seizures.~      The standard treatment for hypoparathyroidism is a form of vitamin D (calcitriol) and calcium~     supplements. Keeping normal blood levels of calcium can be difficult. Sometimes there is too~     much calcium in the urine even if the calcium levels in the blood are low. High calcium in~     the kidneys and urine can cause problems such as calcium deposits in the kidney~     (nephrocalcinosis) or kidney stones. High levels of calcium in the kidney may keep the kidney~     from functioning normally. Treatment with PTH will replace the hormone you are missing. Your~     disease may be better controlled on PTH than on calcium and calcitriol.~      Researchers at the NIH have conducted prior studies to establish synthetic human parathyroid~     hormone 1-34 (HPTH) as a treatment for hypoparathyroidism. Other studies have shown that PTH~     may improve calcium levels in blood and urine. The primary purpose of this research study is~     to evaluate the effects of synthetic human parathyroid hormone 1-34 (HPTH) replacement~     therapy on bone in adults and teenagers with hypoparathyroidism.~      The study takes 5 (Omega) years to complete and requires 12 inpatient visits to the National~     Institutes of Health Clinical Center in Bethesda, MD. The first visit will help the study~     team decide whether you are eligible. This visit will last 2 to 3 days. After taking calcium~     and calcitriol for 1 - 7 months you will return to the NIH Clinical Center for the baseline~     visit. The baseline visit is the visit that you will start your PTH; you will also undergo a~     bone biopsy during the visit. The baseline visit may last 7 to 10 days. You will then take~     PTH twice a day for 5 years. You will be asked to return to the NIH clinical center every 6~     months for 10 follow-up visits. During one of the follow-up visits, you will have a second~     bone biopsy taken from the other hip. That second biopsy will be done after 1 year, 2 years,~     or 4 years of taking PTH; the researchers will assign the timing of the second biopsy~     randomly. You will be asked to go to your local laboratory for blood and urine tests between~     each follow up visit. At first the blood tests will occur at least once a week. Later, you~     will need to go to your local laboratory for blood tests at least once a month and urine~     tests once every 3 months. The local laboratory visits and follow-up visits at the NIH~     Clinical Center will help the study team determine whether the HPTH treatment is controlling~     your hypoparathyroidism.~   "
241361|NCT00395447|"~     The objective of this study is to prospectively estimate the all-cause complication rates at~     6-months for patients undergoing generator replacement due to elective replacement indicator~     (ERI), advisory, or upgrade without a planned system modification or with a planned system~     modification. Secondarily, this study aims to compare the influence of baseline variables~     contributing to the all-cause complication rates for subjects undergoing generator~     replacement.~   "
241362|NCT00395434|"~     The purpose of this study is to determine the safety and tolerability of three dose levels of~     combretastatin A4 phosphate (CA4P) given intravenously (IV) in combination with bevacizumab~     every 14 days in patients with advanced solid tumors. The maximum tolerated dose will be~     defined if it is at one of the three dose levels under study.~   "
241363|NCT00395421|"~     This study is being conducted to see if the investigational medication, valopicitabine, is~     safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis~     C infection.~   "
241364|NCT00395408|"~     The purpose of this study is to compare the effect of montelukast with placebo and~     beclomethasone on the average rate of linear growth over a period of 56 weeks in children~     with mild asthma.~   "
241365|NCT00395395|"~     This is a phase I study to analyze the effect of water and food intake on the bioavailability~     and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in~     post-menopausal women.~   "
241366|NCT00395382|"~     Cardiovascular disease (CVD) is the commonest cause of mortality in patients with chronic~     kidney disease (CKD) and end-stage kidney disease (ESKD). Reasons for the greater incidence~     of CVD in this group include traditional CVD risk factors of hypertension, dyslipidemia and~     diabetes but more importantly also include non-traditional risk factors such as calcium and~     phosphate imbalance. The latter is thought most likely to contribute to vascular~     calcification, especially for those on dialysis, and this in turn leads to arterial stiffness~     and left ventricular hypertrophy, the two commonest cardiovascular complications. Arterial~     stiffness and calcification have been found to be independent predictors of all-cause and~     cardiovascular mortality in CKD. Few studies, though, have looked at both structural and~     functional changes associated with calcification and there have been very few interventional~     studies addressing this issue.~      Control of calcium and phosphate levels in CKD can occur with the use of medications that~     reduce elevated serum phosphate (phosphate binders, mostly calcium-based) and those to treat~     hyperparathyroidism (vitamin D and more recently calcium sensing receptor agonists called~     calcimimetics). These pharmacological managements addressing calcium and phosphate imbalance~     reduce vascular calcification and CVD. Bisphosphonate therapy may also have a role in~     reduction of calcification.~      Low bone mineral density (BMD) is common in CKD patients and predicts increased fracture risk~     similar to the general population. Bisphosphonate therapy improves BMD and lowers the~     fracture risk. Bisphosphonates may also have a role in secondary hyperparathyroidism to~     reduce hypercalcemia and allow for more aggressive calcitriol treatment. Recent studies have~     addressed the possibility of bisphosphonates reducing the progression of vascular~     calcification in CKD and revealed that the extent of calcification may be suppressed in~     association with a reduction in chronic inflammatory responses.~      The investigators aim to perform a prospective, randomised study assessing the impact of~     alendronate on cardiovascular and bone mineral parameters. This will be a single-centre study~     involving subjects with CKD Stage 3 (those patients with GFR between 30 and 59ml/min).~     Arterial stiffness (by pulse wave analysis and pulse wave velocity) and vascular~     calcification (using CT scans through superficial femoral artery) will be followed as well as~     serum markers of calcium, phosphate and PTH. Differences in these end-points will be compared~     between participants taking alendronate and those not. The study will be conducted over a 12~     month period and the investigators aim to recruit about 50 patients (25 on alendronate and 25~     control).~   "
241367|NCT00395369|"~     Cognitive and neurological dysfunction after coronary artery bypass surgery (CABG) is common~     and multi-factorial in origin. Several previous studies have shown that intraoperative~     aprotinin administration may be neuroprotective.in the current prospective randomized study,~     the effect of intraoperative aprotinin administration on the integrity of the optic nerve and~     retinal nerve fiber layer will be examined. Optical coherance tomography will be used to~     examin the optic nerve and retinal nerve fiber layer.~   "
241368|NCT00395356|"~     The goal of the study is to measure the effect of an approach including phases of active~     weight loss broken by weight stabilisation periods (named intermittent weight loss) on the~     metabolic profile.~      First, the intermittent weight loss approach will contribute to create an artificial~     transitory steady state during the weight loss treatment that will help to minimize the~     adverse effects of the standard approach on muscle mass and resting metabolic rate. Second,~     despite a comparable fat mass loss, the intermittent weight loss approach will improve the~     metabolic profile to a greater degree compared to the standard approach. Finally, the~     intermittent weight loss approach will be associated with less weight regain after the~     treatment since the beneficial effect on muscle mass and metabolic rate.~   "
241369|NCT00395343|"~     A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2~     Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin~     combination therapy.~   "
241370|NCT00395330|"~     In the weeks following the terrorist attacks of September 11, 2001, many patients presented~     to their physicians with complaints related to exposure to the debris. These included nose~     and throat complaints (drip, congestion, sore throat), increased GE reflux (heartburn,~     regurgitation, retrosternal chest burning) and respiratory symptoms (worsening cough,~     wheezing, shortness of breath, chest tightness, sleep disturbance). In addition, there was a~     disproportionate rate of self-reported worsening asthma symptoms in patients living in Lower~     New York 5-9 weeks after the attack; those with exposure to the dust cloud fared worse. The~     functional abnormalities of firefighters with exposures to dust at the WTC site has been~     recently described. However, the effects of WTC dust exposure on pulmonary function in~     residents and workers near the WTC site remain unclear. This study will retrospectively~     review the charts of all patients referred to the pulmonary function laboratory for~     evaluation of symptoms following exposure to WTC dust. The main objectives for this study~     will be to characterize the functional abnormalities in these subjects.~   "
241371|NCT00395317|"~     SB-683699 is an oral medication that is thought to reduce the number of active white blood~     cells entering the brain; these white blood cells are part of the disease process for MS.~     This study will look at whether different doses of SB-683699 are effective and safe in~     patients with relapsing remitting MS.~   "
241372|NCT00395304|"~     Asthma is a common, serious illness among children in the United States. While a low dose of~     inhaled corticosteroids (ICS) may effectively control symptoms, some children may require~     additional medications to maintain adequate asthma control. This study compares the~     effectiveness of a higher dose of ICS, ICS combined with a long-acting beta-agonist (LABA)~     medication, and ICS combined with a leukotriene receptor antagonist (LTRA) medication at~     reducing the impact and severity of asthma exacerbations that occur in children with mild to~     moderate persistent asthma.~   "
241373|NCT00395291|"~     The objective of this study is to determine MK-0677 increases IGF-1 in patients with end~     stage renal disease (ESRD) on hemodialysis.~   "
241374|NCT00395278|"~     Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively~     detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We~     would like to apply this technique to develop an assay for detecting antibodies to HHV-8~     (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially~     plan to examine samples from patients with Kaposi's sarcoma, since all those patients are~     almost certainly infected with HHV-8. We are thus using samples from patients with previously~     diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository~     operated by SAIC Frederick or in Rockville, MD.~   "
241375|NCT00395265|"~     Venous thrombosis is the development of a blood clot in a vein. Post-thrombotic syndrome~     (PTS) is a painful condition that can develop following a venous thrombosis in one of the~     deep veins of the leg. While PTS is mainly thought to occur because of damage to the vein,~     other factors may be responsible for the development of this condition. This study will~     analyze genetic and biologic samples from participants of a previous study to examine other~     possible causes of venous diseases and PTS.~   "
241376|NCT00395252|"~     This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in~     patients with R0 OR R1-resected pancreatic cancer.~   "
241377|NCT00395239|"~     The investigators propose to study the patterns of metabolite changes in subjects with asthma~     to determine if there is a predictable pattern prior to, and post, clinical exacerbation.~      Hypothesis: 1. Metabolite profiles will change prior to detection of a clinical exacerbation~     in subjects with asthma.~      2. There will be a measurable temporal delay before metabolite profiles return to baseline~     following anti-inflammatory therapy of an exacerbation of asthma.~   "
241378|NCT00395226|"~     Rosacea is a common chronic dermatological condition, characterized by recurrent or~     persistent redness, permanent dilation of small blood vessel causing small red lesions, and~     papules/pustules. The signs of rosacea are usually confined to the face, but may appear on~     the neck, scalp or trunk. Opthalmologic findings are also common. Rosacea is usually~     described as being most common in fair skinned women over 40. The purpose of the study is to~     determine whether oral Zinc Sulfate treatment is an effective treatment for facial rosacea.~   "
241379|NCT00395213|"~     This study will evaluate the risks and benefits of treatment with a selective serotonin~     reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in children and adolescents~     with a pre-specified anxiety disorder, depressive disorder, eating disorder, or~     obsessive-compulsive disorder.~   "
241380|NCT00395200|"~     Hypothesis: Intravenous administration of bone marrow-derived autologous adult human~     mesenchymal stem cells is a safe novel therapeutic approach for patients with multiple~     sclerosis.~      Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) is a phase I/IIA trial designed to~     establish the safety of intravenous administration of bone marrow-derived autologous adult~     human mesenchymal stem cells to patients with multiple sclerosis.~   "
241381|NCT00395187|"~     This study will investigate the efficacy of Photodynamic Therapy (PDT), which is the~     therapeutic use of photochemical reactions, in treating hidradenitis suppurativa (HS), a~     chronic inflammatory condition affecting areas of skin with sweat glands. We expect that PDT~     is effective in treating HS.~   "
241382|NCT00395174|"~     The purpose of this study were to obtain additional evidence in support of the safety and~     immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to~     establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a~     licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary~     estimate of the relative efficacy of the two vaccines against culture-positive influenza-like~     illness during the subsequent epidemic.~   "
241383|NCT00395161|"~     Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial~     infection and sepsis remain the leading acquired causes of morbidity and mortality in~     critically ill children. Subsequent use of antibiotics to treat nosocomial infection and~     sepsis is considered a major attributable factor in the rise of antibiotic-resistant~     organisms in this population of children. This study will use a double-blind, randomized,~     controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide,~     zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill~     children.~   "
241384|NCT00395148|"~     High levels of good cholesterol (HDL) in our blood decreases our chance of having a heart~     attack. This relates in part to the role good cholesterol plays in reducing build up of fat~     in the arteries. However, good cholesterol has many other protective effects. We have~     recently identified three enzymes (proteins) activated by HDL in cells lining the blood~     vessels, which may be responsible for some of HDL's protective actions.~   "
241385|NCT00395135|"~     The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the~     first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight~     loss at the end of the second year of treatment (Week 104)~   "
241386|NCT00395122|"~     The study is designed to evaluate the ability of optical coherence tomography and VCC~     scanning laser polarimetry to measure and identify the pattern of band atrophy of the optic~     nerve in patients with long standing chiasmal lesions. The hypothesis is that these new~     technologies are able to identify such pattern. The idea is that by using eyes with band~     atrophy one is able to investigate the ability of the new technologies in measuring the~     retinal nerve fiber layer particularly in the nasal and temporal portions of the optic nerve.~   "
241387|NCT00395109|"~     Patients with head and neck cancer will be imaged with PET scan and CT scan in order to~     determine areas of the tumour that are hypoxic.~      It is hypothesized that PET /CT will provide information on hypoxia of the tumors and tumor~     regions in head and neck cancer patients.~   "
241388|NCT00395096|"~     Asthma is one of the most common childhood diseases. It is chronic and often severely~     disabling. The amount of nitric oxide that is exhaled while breathing increases with airway~     inflammation, a symptom of asthma. This study will examine the results from a previous study,~     the Cincinnati Asthma Prevention (CAP) study, to evaluate the effects of environmental and~     genetic factors on exhaled nitric oxide (eNO) levels and to determine the relationship~     between eNO and asthma severity.~   "
241403|NCT00394888|"~     We are conducting a study on the possible presence of PHACES in children with large facial~     hemangiomas and lumbosacral hemangiomas of infancy (hemangioma in the lower back) . With this~     study we hope to better understand the risk of this syndrome and to develop guidelines for~     its evaluation and management.~   "
241389|NCT00395083|"~     EXECUTIVE SUMMARY:~      Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention~     incorporating self-management education, an action plan, and case-management to decrease the~     risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans~     with severe COPD.~      Hypotheses:~      Primary Hypothesis:~      Veterans with COPD who receive a self-management program incorporating education sessions,~     development of an action plan, and case-management will have a decreased risk of COPD~     hospitalization compared to standardized COPD care.~      Primary Objective:~      In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management~     program for reducing the risk of COPD hospitalization in veterans with severe COPD in~     comparison to patients receiving standardized COPD care.~      Secondary Hypotheses:~      Compared with standardized COPD care, veterans with COPD who receive a comprehensive~     self-management intervention will have: A) decreased health-related costs resulting from~     decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and~     average length of stay due to both COPD and all-cause admissions, and C) improvement in a set~     of outcomes including mortality, health-related quality of life, medication adherence,~     patient satisfaction, disease knowledge, skill acquisition and self-efficacy.~      Secondary Objectives:~      To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health~     outcomes of a comprehensive self-management program compared to standardized COPD care among~     patients with severe COPD measured by:~      A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical~     outcome measures~        1. Mortality~        2. Health-related quality of life measured by generic and COPD-specific measures~        3. Patient satisfaction~        4. Medication adherence~        5. Disease knowledge, skill acquisition and self-efficacy~      In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will~     be randomly assigned to either a comprehensive case management program or standardized COPD~     care. The comprehensive group will receive an initial, intense education program with~     development of an action plan, and regular telephone contacts by a case manager in addition~     to standardized COPD care. Patients allocated to the control arm will receive standardized~     care that incorporates guideline-based recommendations including influenza vaccination, a~     short-acting bronchodilator, and either a long-acting bronchodilator or inhaled~     corticosteroid inhaler.~      The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites~     followed by the full study in which an additional 8 sites will enroll patients over the next~     24 months. As a result, 180 patients will be initially enrolled in the feasibility study over~     the first year and the remaining 780 patients will be enrolled in the second and third years~     of the study when the full study is implemented. Subjects will be followed until the~     completion of the study, for at least one, and up to four years. The primary outcome is time~     to first COPD hospitalization.~   "
241390|NCT00395070|"~     To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide~     (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.~   "
241391|NCT00395057|"~     This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as~     Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related~     macular degeneration~   "
241392|NCT00395044|"~     This is a study to evaluate the efficacy of the medication gabapentin in treating persons~     with cannabis dependence.~   "
241393|NCT00395031|"~     The aim of the protocol is to study the effects of 320 mg/day of ziprasidone (Geodon) on~     glucose and lipid metabolism of patients with both Diabetes Type II (DM) and schizophrenia or~     schizoaffective disorder, after switching their antipsychotic medication/s from typical~     and/or atypical to ziprasidone monotherapy.~   "
241394|NCT00395018|"~     The purpose of this clinical research study is to learn if the study drug entecavir will~     prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic~     liver transplant (OLT) due to HBV infection.~   "
241395|NCT00395005|"~     Urinary kallikrein excretion is known to increase in patients with nephrotic syndrome and~     sick cell disease, but decrease in patients with chronic kidney disease or uremia. Some of~     authors consider urinary kallikrein is a marker of nephropathy. To evaluate the possible role~     of kallikrein kinin system in chronic kidney disease, we conduct a retrospective longitudinal~     observation study. Patients who participating in the “Efficacy of Pentoxifylline on Chronic~     Kidney Disease” study are included in the study. The morning spot urinary kallikrein and~     cytokines are measured at the time point of 0 and 12 month in addition to clinical~     parameters. The correlation of urinary kallikrein and cytokine concentration will be~     evaluated. Using multiple regression model, the relationship of urinary kallikrein excretion~     with degree of proteinuria, creatinine clearance and other clinical parameter will also be~     evaluated.~   "
241396|NCT00394992|"~     The primary aim of this study is to investigate whether the addition of the new anti-cancer~     drug bevacizumab (Avastin) to the combination of the chemotherapeutic agents capecitabine~     (Xeloda) and oxaliplatin (Eloxatin) reduces (slows down) the recurrence of metastatic disease~     after a radical resection of liver metastases in patients with colorectal cancer.~   "
241397|NCT00394966|"~     This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled~     study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy.~     Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before~     initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV~     Subject Diary through Day 6. The quality of life assessment as measured by the Functional~     Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of~     chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734~     pharmacokinetic assessments will be collected. The study is to be conducted in conformance~     with Good Clinical Practice.~   "
241398|NCT00394953|"~     This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa,~     administered at extended dosing intervals, in the maintenance treatment of anemia in patients~     with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving~     once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to~     receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360~     micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study)~     or intravenous darbepoetin alfa every 2 weeks before switching to once monthly~     administration. The anticipated time on study treatment is 3-12 months, and the target sample~     size is 100-500 individuals.~   "
241399|NCT00394940|"~     Chronic obstructive pulmonary disease (COPD) is a condition that is characterized by airway~     obstruction due to inflammation. Levels of inflammatory proteins may be linked to when and to~     what extent COPD develops. This study will use data collected during the Tucson~     Epidemiological Study of Airway Obstructive Disease (TESAOD) and its 33-year follow-up to~     determine the relationship between inflammatory protein expression and COPD.~   "
241400|NCT00394927|"~     The purpose of the survey is to explore through a structured interview and patient~     examination the rate and distribution of neurological and systemic adverse effects related to~     antiepileptic treatment. Adverse effects and considerations to modify the therapy will be~     assessed in pediatric and adult patients with controlled as well as uncontrolled epilepsy~     with different seizure types~   "
241401|NCT00394914|"~     This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the~     efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms~     in asthmatic participants exposed to picornavirus respiratory infections. Participants will~     be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses).~     Participants will be followed for an additional 14 days.~   "
241402|NCT00394901|"~     The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment~     of postherpetic neuralgia in a dose-ranging manner.~   "
241410|NCT00394797|"~     The purpose of this study is to try and determine whether repair of moderate ischemic mitral~     regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on~     survival.We will compare patients undergoing CABG + mitral repair or CABG only groups.~     Primary endpoints include late survival. Secondary endpoints include event free survival,~     symptoms, and echocardiographic outcomes.~   "
241411|NCT00394784|"~     This research is important because it allows for the determination of resistance rates to~     antibiotics that may not be frequently tested by the clinical microbiology laboratory at~     University of Pittsburgh Medical Center (UPMC)-Presbyterian. It also will provide antibiotic~     minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying~     the best empiric antibiotic option for gram-negative blood stream infections based on known~     pharmacodynamic parameters.~   "
241412|NCT00394771|"~     This is a 4-arm study to evaluate and compare bleeding patterns between three different doses~     of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will~     receive physical and gynecological exams, including Pap smear. During the study, all~     participants will be required to complete a diary~   "
241413|NCT00394758|"~     1. To compare the recurrence rate between the use of laser vaporization and ultrasonic~          surgical aspiration in the treatment of vulvar and vaginal dysplasias~        2. To compare healing related complications, post-operative pain, and scarring between the~          two procedures.~   "
241414|NCT00394745|"~     The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions~     and other parameters in lipid metabolism in patients with essential hypertension and~     metabolic syndrome.~   "
241415|NCT00394732|"~     Surgical methods offered to patients with chronic low back pain are controversial. In~     addition, new and expensive treatment methods like total disc replacemet (TDR) are a~     challenge for the health care services. At present, ongoing randomized studies in both Europe~     and USA are comparing TDR to fusion. However, to our knowledge, no randomized trials have~     compared TDR to non-surgical treatment. The aim of the present study is to evaluate the~     effect of a comprehensive and structured non-surgical treatment with TDR surgery in patients~     with chronic low back pain and localized degenerative disc changes.~      Main hypothesis: There is no difference in treatment effect between surgery with lumbar total~     disc prosthesis and a multidisciplinary rehabilitation program measured by Oswestry~     Disability Index after 1 and 2 years.~      Secondary hypothesis: There is no difference in cost - effectiveness between surgery with~     lumbar disc prosthesis and a multidisciplinary rehabilitation program after 1 and 2 years.~   "
241416|NCT00394706|"~     The purpose of this study is to look at two different treatments during a cardiac arrest that~     occurs outside of the hospital and whether either or both treatments will increase the number~     of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping~     blood to the body.~   "
241417|NCT00394693|"~     The primary objective of this study is to evaluate the efficacy of a four-month dosing period~     of intra-lesional injection of TG1042 in patients with relapsing CBCL.~      Patients will receive intra-tumoral injections of an adenoviral vector construct containing~     the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with~     anti-tumor activity. This local administration induces tumour cell killing at the injected~     tumour sites.~   "
241418|NCT00394680|"~     Options for coronary revascularization include stent implantation and coronary bypass~     surgery. Both modalities have their unique advantages and disadvantages in terms of clinical~     outcomes as well as financial impact on the medical system. We wish to investigate the late~     results of patients undergoing coronary revascularization, the need for re-hospitalization,~     re-intervention, patient satisfaction as well as the financial burden on the medical system.~     The study will be conducted by historical prospective review of hospital records in~     conjunction with records of the medical insurance companies (HMO's).~   "
241419|NCT00394667|"~     Purpose:~      To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine~     versus placebo in obese patients~   "
241420|NCT00394654|"~     This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR~     in adult patients with atopic asthma.~   "
241421|NCT00394641|"~     The study aims to evaluate the impact of a possible new treatment for hypertonia,~     contributing to the motor disability in children with cerebral palsy (CP).~      This study follows a 2005-2006 pilot study, that demonstrate a significant motor improvement~     in 4 children exposed to low tones via stereophonic Headphones.(A possible mechanism is a~     deep brain stimulation outspreading from the auditory pathways in certain tones) The goal of~     this study is to perform a double blind randomized placebo-controlled trial (RCT) on 30~     children.~      A three-arm study, with one group receiving the proposed treatment-music with low tones and~     the other two groups receiving a placebo (music without tones or stories) will be performed.~      clinical and a non invasive laboratory measurements (surface EMG) related to spasticity,~     active and passive range of movement, isometric strength and upper and lower body function~     would be measured both before and after the treatment .the assessments will include also a~     Visual assessment , evaluation of gaze coordination and a quality of life and a caretaker~     burden questionnaires.~   "
241422|NCT00394628|"~     Phase 1b of the study, will evaluate the safety and tolerability of AQ4N treatment at three~     different dose levels.~      Phase 2a of the study, will further evaluate the safety, tolerability, and in addition~     efficacy of AQ4N treatment at a tolerated dose selected from Phase 1b.~   "
241423|NCT00394615|"~     In this research study of metabolic imaging in locally advanced rectal cancer, we hope to~     learn whether new medical imaging technology can help predict the response of rectal cancer~     to preoperative chemotherapy and radiation therapy. Ultimately we hope this information will~     in the future help us predict which patients will benefit from more or less aggressive~     initial therapy for their rectal cancer.~   "
241498|NCT00393627|"~     Sleep disturbances are widespread among demented residents of board and care homes and are a~     leading cause for transfer into nursing homes. This study is a randomized controlled clinical~     trial to evaluate the efficacy of a 4-week Sleep Education Program (SEP) for demented~     residents of board and care homes who are experiencing sleep disturbances. Residents of adult~     family homes (board and care homes with 2-6 residents) will be randomized into SEP or usual~     care control. Analysis of outcomes will determine whether the SEP is feasible and effective~     in adult family home settings, and whether the SEP delays transition into higher levels of~     institutional care.~   "
241424|NCT00394602|"~     The primary objectives of this study are:~        1. To assess the preferences of cancer patients scheduled to receive chemoradiation and~          caregiver controls for side-effects of chemoradiation.~             1. To compare preferences of cancer patients to those of healthy individuals.~             2. To compare how patients' preferences for side-effects of chemoradiation change over~               time.~        2. To longitudinally assess the quality of life of cancer patients scheduled to receive~          chemoradiation.~        3. To determine the impact of nausea and vomiting associated with chemoradiation on~          patients' quality of life and evaluate potential change throughout the duration of~          chemoradiation treatment.~   "
241425|NCT00394589|"~     This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX)~     in subjects aged 18 and older with active RA is being conducted to assess whether increasing~     either the infusion dose or infusion frequency in patients presenting with a disease flare~     after an initial response to infliximab results in a significant improvement in disease~     activity.~      Subjects responding to an initial infliximab treatment regimen, who flare during continuation~     of treatment at 3 mg/kg administered every 8 weeks, will be randomly assigned to one of 3~     different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions~     for a total duration of 24 weeks. The infliximab control group and the infliximab increased~     dose group are evaluator and subject-blinded. The increased frequency group is not blinded.~     Clinical assessments of disease activity will be based the European League Against Rheumatism~     (EULAR) criteria for response. Safety parameters will be assessed at every infusion.~      A disease flare is defined by an increase in DAS28 with 0.6 or more at screening, when~     compared to the DAS28 score measured immediately prior to the last Remicade® infusion and~     depends upon the actual score as well. Since prior to enrollment, the subject received~     Remicade® as per routine clinical practice, the days on which infusions were administered and~     assessments are done during the induction period do not have to be exactly at Week 2, 6 and~     14.~        -  Drug: Infliximab Control (double-blinded)~        -  Drug: Infliximab Increased Dose (double-blinded)~        -  Drug: Infliximab Increased Frequency (open-label)~   "
241426|NCT00394576|"~     1. Research question Can a web-based nutritional educational intervention improve~          phosphorus knowledge and control of phosphorus intake?~        2. Experimental design~           Following enrollment and informed consent, subjects will be randomized to one of two~          arms (group1: usual care; group 2: usual care plus Internet-based nutrition module). All~          subjects will undergo baseline data collection, consisting of:~             1. Short form of the test of functional health literacy in adults: categorizes~               individuals as having adequate, marginal or inadequate health literacy.~             2. Chronic Kidney Disease (CKD) Knowledge Assessment Tool: addresses nutritional~               knowledge of CKD.~             3. SF-12 Health Survey version 2: a 12-item measure of health related quality of life.~             4. Kidney Disease Self-Management Survey: a 58-item Likert scale based on theories~               important for self-management in chronic disease.~             5. 3-Day Dietary Diaries~             6. Lab work:~           i. Serum phosphorus, calcium and parathyroid hormone levels. ii. Circulating endothelial~          cells, a novel marker for vascular damage.~           Following baseline data collection, group 1 will continue with their scheduled clinic~          visit, while group 2 will spend approximately 30 minutes completing a web-based~          nutrition module. After completion of the module, patients will proceed with their~          scheduled clinic visit.~           All subjects will then be asked to return in 30-60 days to repeat some of the survey~          information and blood work~        3. Major risks to subjects There is the potential for some mild discomfort from the~          necessary blood draws, which occur twice per subjects.~        4. Potential benefits to subjects Subjects randomized to the web-based module may receive~          an educational benefit from it.~        5. Consent procedures Only individuals who can provide their own consent can participate.~          Upon agreeing to enroll, a study coordinator or investigator will provide the subject~          with a copy of the consent form, and will remain available to answer any questions.~   "
241427|NCT00394563|"~     The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain~     due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624~     compared to placebo over a 4 month period.~   "
241428|NCT00394550|"~     This is a research study of the effect of treating laryngomalacia (floppiness of tissue on~     top of the voice box that can possibly block breathing) found in association with obstructive~     sleep apnea (blockage of breathing while sleeping).~      The purpose of this study is to determine which is the best treatment for children with~     obstructive sleep apnea and laryngomalacia: adenotonsillectomy alone or adenotonsillectomy~     with laser supraglottoplasty (removal of tissue on top of the voice box to open the airway).~   "
241429|NCT00394537|"~     Passing a bronchoscope through the airways frequently causes a stress response even though~     patients are sedated. This stress response is usually an increase in pulse and blood~     pressure, which may have undesirable effects on the heart and circulation.~      We plan to give patients labetalol (a beta blocker which reduces pulse and blood pressure) in~     addition to normal sedation, to patients undergoing bronchoscopy in our department.~   "
241430|NCT00394524|"~     High blood sugars increase the risk of complications and death in diabetic patients admitted~     to the hospital. Recent studies hve shown that strict blood sugar control with intravenous~     (IV) insulin lowers the risk of such complications and death in the ICU. Several insulin~     infusion protocols have been reported in the literature, but it is not known which is the~     best. These protocols use tables and formulas that may be confusing and difficult to follow.~     To facilitate patient care, insulin protocols could be placed on a computer and used at the~     patient's bedside to direct the nursing staff administering the IV insulin. The Glucommander~     is one of such computer-derived insulin infusion protocol which has been used successfully in~     patients with diabetes since 1984. We hypothesize that management of inpatient hyperglycemia~     with a computer-guided intravenous infusion protocol will facilitate smoother glycemic~     control with a lower rate of low blood sugars than treatment following a standard insulin~     infusion algorithm in the medical intensive care unit. We will aim to determine differences~     in glycemic control between treatment with a computer-guided intravenous infusion protocol~     (Glucommander) and a standard insulin infusion algorithm in critically ill patients in the~     ICU.~   "
241431|NCT00394511|"~     Randomized phase III trial to compare treatment with or without adjuvant radiation therapy in~     men with stage III prostate cancer who have had radical prostatectomy and lymphadenectomy~     recently. Radiation therapy uses high-energy x-rays to damage tumor cells and may be an~     effective treatment for prostate cancer.~   "
241554|NCT00392847|"~     Child psychological/behavioural disorders such as withdrawal may persist when the~     psychosocial context is unfavourable. Health promotion strategies (Olds' paradigm) have~     proved their efficacy in vulnerable populations. CAPEDP project sets out to evaluate a~     program of home visits in France~   "
241911|NCT00388141|"~     The purpose of this study is to determine whether systematic use of the Newborn~     Individualized Developmental Care Assessment Program (NIDCAP®) improves the neurologic~     development of children and the parental competence of mothers.~   "
241432|NCT00394498|"~     Eighty-six patients with heart attacks will be identified at our hospital. Post heart attack~     we will assess heart function, blood flow to the heart, and heart cell function. We will~     assess these parameters using nuclear cardiology scans that are used in everyday cardiology~     practice. The patients will then be divided into 2 groups. One group will receive a~     medication called G-CSF and the other group will receive a placebo. We will give this drug~     (1-2ml) for 4 days beneath the skin. We will take the patients blood during this time and~     measure how the drug affected their blood. The patients will all have the nuclear cardiology~     tests again in 6 weeks and 6 months to see how their heart is functioning. As well, they will~     have a six month angiogram. All the patients will otherwise receive optimal care from their~     Cardiologist. They will be seen at 6, 12, 24, and 52 weeks to assess them clinically.~      This study will test the effects of G-CSF on the heart function of patients who have had a~     heart attack. It is a medication that that has been shown in an animal model to improve heart~     function after a heart attack. It is a medication that has been used for many years to treat~     patients with cancers and to increase the number of cells donated by healthy bone marrow~     donors. It has no serious side effects. It works by increasing the number of a person’s own~     stem cells in the blood. Stem cells are special cells that are present in our bodies that~     have the ability to form new cells. It had been thought that the heart could not make new~     cells after it has been damaged. Other investigators have shown that this might not be the~     case. It is now thought that after an injury, stem cells from the bone marrow can transform~     into cells of the injured tissue. Therefore, we are trying to increase the number of stem~     cells in the circulation with G-CSF so as to increase repair in the heart after it has been~     damaged. This strategy has never been tried in human beings and if successful could greatly~     reduce death and suffering from heart disease.~   "
241433|NCT00394485|"~     Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs.~     tiotropium alone among patients with moderate chronic obstructive pulmonary disease~   "
241434|NCT00394472|"~     The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a~     Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients~     with an incomplete response to PPI treatment.~   "
241435|NCT00394459|"~     Primary Objective: The primary objective is to demonstrate that the safety of Perifix New is~     non-inferior to using Perifix Standard when applied for thoracic epidural anaesthesia.~      Primary Endpoint: Incidence of spontaneous paraesthesia during catheter insertion~      Secondary Objectives: The secondary objectives are to determine the safety and performance of~     the investigational product: frequency of inadvertent vascular cannulation, difficulties~     involved in insertion and removal of the catheter, other safety features and data for the~     evaluation of handling characteristics.~      Title: Randomised, prospective, single-blind, controlled, study on the safety of two epidural~     catheters in patients undergoing surgery under thoracic epidural anaesthesia~      Investigational Product: Perifix Epidural Anaesthesia Catheter~      Test Product: Perifix New~      Reference Product: Perifix Standard~      Number of Sites and Countries: 1 site in The Netherlands~      Indication: Thoracic epidural anaesthesia~      Study Design: Randomised, prospective, single-blind, controlled study in 1 study center,~     phase IV~      Perifix New and Perifix Standard meet all the appropriate provisions of the relevant~     legislation implementing European Directives (both have CE-marking).~      Study Duration: 2 year duration~      Study Start: March-April 2005~      Sample Size: n = 2*70 patients~   "
241436|NCT00394446|"~     Phase 1, Multiple Dose Study of MPC-6827 in Subjects with Refractory Solid Tumors.~   "
241437|NCT00394433|"~     The purpose of this research study is to determine if the combination of docetaxel,~     cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric~     cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is~     believed to stop the formation of new blood vessels that carry nutrients to tumors.~     Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin~     and irinotecan are traditional chemotherapy agents that have been tested together in another~     clinical trial for esophageal and gastric cancer. It is hoped that adding bevacizumab to this~     regimen will make the treatment more effective.~   "
241438|NCT00394420|"~     The purpose of this preliminary study was to evaluate the intervention completion rate among~     cigarette smokers enrolled through the Emergency Department (ED) in a tobacco quitline (QL)~     and to assess the feasibility of a randomized controlled trial assessing the efficacy of this~     intervention.~   "
241439|NCT00394407|"~     High blood glucose levels in hospitalized patients with diabetes are associated with~     increased risk of medical complications. Improved glucose control with insulin injections may~     improve clinical outcome and prevent some of the hospital complications. It is not known;~     however, what is the best insulin regimen in hospitalized patients. The use of repeated~     injections of regular insulin (known as sliding scale regimen) is one of the most commonly~     used insulin regimen for glucose control in hospitalized patients with diabetes. Recently,~     the combination of basal and rapid acting insulins has been shown to improve glucose control~     with lower rate of hypoglycemia (low blood sugar).~   "
241440|NCT00394394|"~     The majority of hypertensive patients require antihypertensive associations to control their~     blood pressure. Most of clinical trials don’t compare different associations using~     Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using~     doses that are not equivalent.~      This randomized trial where patients and investigators are blinded and compares the~     effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and~     Enalapril.~   "
241441|NCT00394381|"~     A phase I/II study to explore the feasibility and efficacy of autologous CIK cells in~     patients with acute myeloid leukemia (AML)/ high grade myelodysplastic syndrome (MDS)~        1. Group 1: As adjuvant therapy in minimal residual disease state after autologous PBSCT.~        2. Group 2: As an adoptive immunotherapy in untreated disease state when conventional~          therapy with curative intent is not applicable~   "
241442|NCT00394368|"~     The aim of this study was to compare the efficacy and tolerability of the fixed combination~     beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with~     moderate to severe asthma~   "
241443|NCT00394355|"~     This is a randomized, multi-center, parallel-group, active-controlled, double-blind study~     evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral~     density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the~     averaged baseline value (the average of the two scan results prior to treatment) to the~     endpoint of treatment time point (the average of the last two valid post-baseline scan~     results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus~     montelukast (ML) 10 mg daily in the evening.~   "
241444|NCT00394329|"~     Asthma is a common, serious illness among children in the United States. It can be~     effectively controlled through the use of preventative medications and rescue medications,~     which are used to control symptoms. This study will evaluate the impact and severity of~     asthma exacerbations that occur in children with mild persistent asthma who are receiving~     various combinations of medications for daily and rescue use.~   "
241445|NCT00394316|"~     X-linked Chronic Granulomatous Disease (CGD) is an inherited disorder caused by an abnormal~     gene that fails to make the protein known as gp91 phox. This protein is part of a group of~     proteins that work to create hydrogen peroxide in neutrophils. Neutrophils are a type of~     white blood cell that helps fight infections. As a result, patients who do not make this gp91~     phox frequently develop life-threatening infections. In addition, these neutrophils often act~     abnormally, resulting in the creation of a granuloma, which is an abnormal collection of~     cells. These granulomas can then become large enough to block organs, such as the bladder~     and/or intestines, causing significant problems. Patients are usually treated with~     antibiotics (often needed for extended periods of time) for the infections caused by CGD, and~     with corticosteroids for the granulomas. However, these drugs do not cure CGD itself, and can~     have significant side effects. Thus patients with CGD do not have a normal life expectancy.~      The only available cure to date for CGD is Bone Marrow Transplantation (BMT), where the~     blood-making cells from a specially matched brother or sister donor (allogeneic) or a~     similarly matched unrelated donor are given to the patient after the patient has undergone~     some kind of chemotherapy or radiation in preparation for receiving the cells. If the cells~     from the donor engraft (or survive in the marrow), the patient can be cured; however, there~     is a risk that the cells may not engraft or that they may later get rejected from the body.~     Also, the cells from the donor can react against the patient, causing a serious disorder~     called Graft Versus Host Disease (GVHD). Although there are a number of methods used to try~     to reduce and/or prevent graft rejection and/or GVHD, these complications can still occur~     even with the newer methods now being developed. The risks of such complications are lower~     when a brother or sister is used as the donor; however, not all patients (even those with~     siblings) will have an ideally matched donor. Hence, transplantation, especially when using~     an unrelated donor, is not always a perfect cure.~      Because the gene responsible for making the gp91 phox is known, it is possible to use gene~     therapy to try to cure this disease. In gene therapy, some of the blood-making cells are~     taken from the patient using a technique called apheresis. The normal gene is placed into the~     cells using special viruses called retroviruses. The cells are then able to produce the~     normal protein. In this trial, the patient will receive a small dose of chemotherapy called~     busulfan, lower than what is traditionally used in allogeneic BMT, and the newly corrected~     cells will then be put back into the patient.~      Even with the best standard of care, a number of patients with CGD will still die from~     infection. For those patients who have an unresponsive or progressive infection and do not~     have a possible sibling donor, their only hope is either a Matched Unrelated Donor (MUD)~     transplant, which has a high risk of causing death itself, or gene therapy. Hence, we would~     propose using gene therapy in these patients as this has less risk of causing death, but can~     still possibly offer a cure. Even if the corrected cells do not remain life long to rid the~     patients entirely of their disease, as long as they persist for even a few months, they would~     be able to at least clear the current infection for which the patients are being considered~     for enrollment in this protocol. Further, they would still be eligible to undergo a matched~     unrelated donor transplant in the event that gene therapy does not confer any benefit.~   "
241446|NCT00394303|"~     Blood glucose levels increase in response to stress, infection or other conditions faced by~     patients in the hospital. This occurs commonly among patients with known diabetes, but also~     among non-diabetic hospitalized patients. Tight glucose control, the maintenance of blood~     glucose levels within normal limits (80-120 mg/dl), has been shown to improve patient~     outcomes in the hospital in several settings, mainly among critically ill patients~     hospitalized in intensive care units.~      We plan to assess the importance of tight glucose control during open-heart surgery. The~     prevalence of hyperglycemia (elevated blood glucose) during this operation is high.~     Hyperglycemia may be associated with increased vulnerability to surgical site infections,~     neurological damage, cardiac and renal injury. Conversely, tight glucose control may be~     associated with hypoglycemia (pathologically low glucose levels) that may results in~     neurological injury. We hypothesize that tight glucose control will improve patient outcomes~     following surgery.~   "
241447|NCT00394290|"~     The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive~     Pressure for SAOS in Down Syndrome patients.~   "
241448|NCT00394277|"~     This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance~     dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety~     of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with~     chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight~     ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS~     180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg~     sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed~     by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc~     weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po~     daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free~     follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size~     is 500+ individuals.~   "
241449|NCT00394264|"~     Musculoskeletal injuries including low back pain (LBP) are a major problem in military~     personnel. These injuries can result from training exercises, job duties, or recreational~     activities. However incurred, many of these injuries can result in limited duty in work or~     training, and can decrease military readiness.~      The National Osteopathic Research Center (ORC) will examine the effectiveness of a specific~     set of Osteopathic Manipulative Treatment interventions referred to as Manual/Manipulative~     Therapy (M/MT) to reduce pain and improve functioning in young active duty military~     personnel.~      The broad overall goal of this proposed research project is to determine the feasibility of~     conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring full~     performance in military personnel in the operational environment. A second goal is to~     estimate the treatment effect size of M/MT in this population.~      The following two hypotheses will guide the data study:~        -  Hypothesis 1: Subjects receiving manual/manipulative therapy for low back pain will~          report less pain at two and four weeks than subjects in the control group.~        -  Hypothesis 2: Subjects receiving manual/manipulative therapy for low back pain will~          achieve greater functioning at two and four weeks than subjects in the control group.~   "
241450|NCT00394251|"~     The primary objective of this study was to compare the safety of dose-dense ABI-007~     (Abraxane) 260 mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense Adriamycin~     plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks~     throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.~   "
241451|NCT00394238|"~     Rheumatoid arthritis is a chronic inflammatory systemic disease. It has a worldwide~     distribution and can affect all age group. The peak incidence is between fourth and sixth~     decade. It is more prevalent in women, and it’s prevalence in the general population in North~     America is between 0.2-1.5%. The etiology of RA is unknown, although clusters of the disease~     in families and high concordance in mono-zydotic twins support genetic predisposition. The~     prevalence of fatty liver disease in patients with rheumatoid arthritis is currently unknown.~     We wish to study the link between the two conditions by performing a son graphic imaging of~     the liver in a cohort of RA patients. If indeed a high prevalence of NAFLD will be found in~     the RA patients, further support will be landed for the link between inflammation and fatty~     liver disease. These findings may also have implications regarding the management and follow~     up of RA patients.~      The validity of sonographic imaging for detection of fatty liver diseases is currently~     accepted: On ultrasonographic, fatty infiltration of the liver produces a diffuse increase in~     echogenicity as compared with that of the kidneys. Ultrasonography has a sensitivity of 89%~     and a specificity of 93% in detecting steatosis and sensitivity and specificity of 77% and~     89% respectively in detecting increase fibrosis.~      In view of all the above data, we expected to find higher prevalence of fatty liver in the~     patients with higher inflammation markers compare with patients with lower markers.~   "
241452|NCT00394225|"~     We assessed the effect of altering inspired gas on the 6MWT distance in COPD. We hypothesized~     that HeO2 would improve walking distance and reduce shortness of breath compared to both RA~     and O2, and potentially improve quality of life for COPD patients.~   "
241453|NCT00394212|"~     It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery~     will not meet their weight loss goal, or may even regain some of the weight they initially~     lost. One possible explanation is that the opening between the stomach pouch and the~     intestine becomes stretched. If this opening becomes too wide, food may be able to pass from~     the stomach to the intestine too quickly - causing patients to feel less full after eating.~      For some patients, doctors may recommend additional invasive surgery to tighten the opening~     between the stomach pouch and the small intestine. Although this may help patients resume~     their weight loss, the risk of complications during a second surgical procedure is~     significantly higher than the risk during the original gastric bypass.~      The purpose of this study is to evaluate an incisionless procedure for patients who have~     either had inadequate weight loss or have regained weight following gastric bypass. The~     procedure is designed to tighten the opening between the stomach pouch and the small~     intestine, which may slow down the passage of food to help patients feel full longer after~     eating.~   "
241454|NCT00394199|"~     To compare the efficacy and safety of the fixed combination asthma drug Flutiform HFA MDI~     with its two components administered alone, fluticasone propionate and formoterol fumarate,~     in adult and adolescent patients with mild to moderate asthma.~   "
241459|NCT00394134|"~     In this study, the researchers will conduct interviews with melanoma patients to describe the~     sun exposure and sun protection practices of patients and their children. The researchers~     will use the findings of this interview study to develop a salient intervention targeted to~     the needs of melanoma patients and their children. The researchers will evaluate the~     intervention in a randomized, controlled trial.~      The specific aims of this study are:~        -  To interview 210 melanoma patients with children 12 years of age or younger to describe~          patients' socio-cognitive and psychological factors, describe patients' and children's~          sun exposure and sun protection practices, and identify determinants of patients' and~          children's sun exposure and protective practices.~        -  To develop a targeted behavioral intervention that is designed to increase patients'~          protective practices to reduce their children's sun exposure, increase patients'~          self-protective practices, decrease the sun exposure levels of patients and their~          children, and positively influence socio-cognitive and psychological determinants of~          child-centered and self-protective practices.~        -  To conduct a randomized, controlled trial in a sample of 360 melanoma patients with~          children 12 years of age or younger to evaluate the targeted behavioral intervention~          consisting of print and video materials. The intervention will be assessed for its~          effects on: 1) child sun exposure and sun protection; 2) patients' protective practices~          to reduce their children's sun exposure; 3) patients' sun exposure and self-protective~          practices; and 4) patients' socio-cognitive and psychological factors that facilitate~          behavior change.~   "
241460|NCT00394121|"~     The purpose of this study is to evaluate the long-term safety of the fixed combination asthma~     drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult~     and adolescent patients with mild to moderate-severe asthma.~   "
241461|NCT00394108|"~     The study aims to evaluate neuropsychological disorders in CABG patients. Measurements are~     performed 1 day before, 6 days, 6 months and 3-5 years after the surgery. The relation with~     cerebrovascular reactivity and embolic load (measured by transcranial Doppler~     Ultrasonography) is evaluated. Two surgery techniques (on- and off-pump CABG) are compared.~   "
241462|NCT00394095|"~     The primary objective of this study is to examine the efficacy of topiramate in combination~     with olanzapine for the prevention of weight gain in youth with bipolar disorder. The~     secondary objective is to examine the tolerability of topiramate in combination with~     olanzapine for the prevention of weight gain in youth with bipolar disorder.~   "
241463|NCT00394082|"~     The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in~     combination with bevacizumab.~      The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab~     for patients with previously untreated advanced/metastatic breast cancer.~   "
241464|NCT00394069|"~     The purpose of this study is to look at the preliminary safety profile of an investigational~     drug in children 3 to 6 months of age with bronchiolitis.~   "
241465|NCT00394056|"~     Tinnitus associated to hearing loss is a high prevalent audiologic disorder with important~     unmet needs as far as therapy is concerned. The present study is exploring the possible~     beneficial effects on tinnitus loudness or annoyance of a combination drug treatment aimed to~     increase the local inhibitory activity of neural circuitries involved in sound perception and~     generation. Modest effects have been reported after 8-12 weeks treatment with~     antidepressants, including high dose paroxetine (up to 50 mg/day). Biologic data suggests~     that the combination of increase of extracellular serotonin using an SSRI and of blockade of~     NK1 receptors using a novel NK1 antagonist may lead to a reduced tinnitus and, possibly,~     improved hearing acuity. To this aim, two 14 day treatment conditions, i.e., SSRI paroxetine~     (20 mg/day) plus the NK1 antagonist vestipitant (25mg /day) or vestipitant alone (25 mg~     /day), will be compared to placebo in patients suffering from tinnitus previously selected~     for their capacity to reliably score the transient attenuation of tinnitus loudness produced~     by lidocaine infusion. Effects on principal endpoints will be collected within 4 hrs from~     last administration, when the plasma levels of vestipitant are calculated to be in the range~     associated to pharmacodynamic effects on VAS anxiety and qEEG (>30 ng/ml). PK, safety and~     tolerability of the paroxetine-vestipitant combination was addressed with preclinical and~     Phase I studies, showing no relevant issue. The cross-over study will require approximately~     24 patients. Audiometry and computer-based Automated Psychoacoustics will be performed as~     instrumental endpoints to support subjective scores. A diary will be used at home to score~     tinnitus severity at home during the study.~   "
241466|NCT00394043|"~     This study investigated whether an eight-week regimen of osteopathic manipulative treatment~     would have immediate and lasting positive effects on the symptoms, functional limitation and~     physiologic impairment associated with Carpal Tunnel Syndrome.~   "
241467|NCT00394030|"~     This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes~     Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the~     bloodstream after a single dose given at different injection sites, and the impact this~     medication has on various substances in the blood. Assessments include ECGs, vital signs,~     repeat blood sampling and monitoring of any side effects.~   "
241468|NCT00394017|"~     To evaluate General Practitioners use and reuptake of an e-learning programme in diagnostic~     evaluation of dementia after an intervention consisting of three mailed reminder letters.~      There is no direct patient involvement in this study.~   "
241484|NCT00393809|"~     This study is designed to assess the safety and preliminary efficacy of five different doses~     of DTA-H19 given as six intravesical infusions into the bladder of patients with superficial~     bladder cancer who have failed intravesical therapy with Bacille Calmette-Guérin~     (BCG).DTA-H19 is a DNA plasmid that contains H19 gene regulatory sequences that drive the~     expression of an intracellular toxin [diphtheria toxin A (DTA) chain]only in cancer cells and~     not in normal cells. In line with the standard procedure for DNA plasmid pharmaceutical~     products, another chemical component will be added to the solution, called PEI~     (polyethlenimine) in a liquid solution, which improves the ability of the DNA plasmid to~     enter the cells.~   "
241485|NCT00393796|"~     This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248~     (SUTENT), for maintenance therapy in advanced urothelial cancer.~   "
244558|NCT00352937|"~     To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion~     imaging in detecting coronary artery disease (CAD) in patients without a previously~     established diagnosis of CAD.~   "
241469|NCT00394004|"~     This study will use focus groups and in-depth individual interviews to explore factors that~     influence the decision of Hispanics and African-Americans with HIV/AIDS to participate in a~     research study.~      HIV-positive Hispanic and African-American patients 18 years of age and older who are~     enrolled in an NIH HIV/AIDS protocol may be eligible for Part 1, Part 2, or both parts of~     this study, as follows:~      Part 1 - Focus group~      Focus group participants of from six to ten people are interviewed together during a~     one-time, 2-hour tape-recorded session to explore how they arrived at their decision to~     enroll in a research study. The group discussion is led by a moderator and a facilitator.~     Before the session begins, participants complete questionnaires that include information~     about their age, race, ethnicity, education and social support. Hispanic participants also~     complete a questionnaire about language preference. At the end of the focus group,~     participants are offered to be interviewed individually, as described below.~      Part 2 - In-depth interview~      An investigator conducts a one-on-one in-depth interview with the participant while a second~     person observes and tape records the interview. The interview may take from 1 1/2 to 2 hours~     to complete. Participants who were not in a focus group are asked to complete questionnaires~     as described in Part 1 above.~   "
241470|NCT00393991|"~     The purpose of this study is to compare the efficacy and safety of the fixed combination~     asthma drug FlutiForm HFA MDI with its two components administered alone, fluticasone~     propionate and formoterol fumarate, and with placebo in adult and adolescent patients with~     mild to moderate asthma.~   "
241471|NCT00393978|"~     The objectives of this study are to determine whether this treatment may be useful for~     reducing cannabis consumption; reducing symptoms of bipolar mania; and weight mitigation~     therapy for individuals on psychopharmacotherapy.~   "
241472|NCT00393965|"~     Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.~   "
241473|NCT00393952|"~     The purpose of this study is to compare the efficacy and safety of the fixed combination~     asthma drug FlutiForm with its two components administered alone, fluticasone propionate and~     formoterol fumarate, and with placebo in adult and adolescent patients with moderate to~     severe asthma.~   "
241474|NCT00393939|"~     This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib~     combined with docetaxel versus docetaxel, administered as first-line treatment, in patients~     with unresectable locally recurrent or metastatic breast cancer.~   "
241475|NCT00393926|"~     The purpose of the study is to examine how a novel robot technology designed for eventual use~     as a home therapy can improve arm function after stroke.~   "
241476|NCT00393913|"~     Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops~     breathing, or experiences shallow breathing for short periods of time during sleep. Daytime~     sleepiness is a common symptom of OSA and may affect an individual's level of alertness~     throughout the day. The primary purpose of this study is to evaluate the relationship between~     the severity of sleep-disordered breathing and levels of daytime alertness at baseline~     (untreated state) in a group of subjects with and without sleep apnea. In addition the change~     in daytime sleepiness in subjects with sleep apnea being treated with a continuous positive~     airway pressure (CPAP) machine, a common treatment for OSA will also be assessed.~   "
241477|NCT00393900|"~     This study will determine if the investigators can use certain tests (eustachian tube~     function tests and gas exchange tests) to predict whether or not a child who had tubes~     surgically placed in their eardrum because of middle-ear disease will redevelop the disease~     again after the tubes quit working.~   "
241478|NCT00393887|"~     Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein~     (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be~     blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome~     is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.~   "
241479|NCT00393874|"~     The purpose of this research study is to evaluate and compare the effects of experimental~     treatments aimed at improving insomnia and nightmares in men and women military veterans~     between the ages of 18 and 60 years old, and who have a condition called Posttraumatic Stress~     Disorder. Insomnia refers to difficulty falling or staying asleep, although enough time is~     allowed for sleeping. Insomnia is also associated with daytime consequences, such as lack of~     energy, irritability, and difficulty concentrating. Nightmares are bad dreams that may or may~     not awaken the sleeper, and that cause discomfort during the daytime.~      Chronic Posttraumatic Stress Disorder (PTSD) refers to symptoms that occur after someone~     experienced or witnessed a life-threatening event, and that persist for three months or more~     after the event. Symptoms include flashbacks, nightmares, feelings of detachment from others,~     sleep disturbances, irritability, anxiety, and efforts to avoid people and places associated~     with the life-threatening event. These symptoms occur after a life-threatening event.~     Symptoms that persist for more than one month indicate the presence of PTSD. In the present~     study, we will study people with chronic PTSD, which refers to PTSD symptoms that persist for~     more than 3 months.~      Efficacy of a treatment is defined as the capacity to produce the desired effects. In this~     study, we will evaluate and compare the capacity of two active experimental treatments to~     reduce insomnia and nightmares associated with PTSD, and one inactive intervention, called a~     placebo, for people who continue to have sleep difficulties despite receiving treatment with~     an antidepressant medication called a selective serotonin reuptake inhibitor (SSRI, like~     Prozac, Paxil, Zoloft, Celexa). The two active experimental treatments are a medication,~     prazosin, and a brief behavioral intervention, which involves exercises and techniques to~     reduce nightmares and improve sleep quality. Prazosin is an approved medication by the Food~     and Drug Administration (FDA) against high blood pressure, but is not FDA-approved for~     posttraumatic insomnia and nightmares.~   "
241480|NCT00393861|"~     The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in~     patients with refractory or relapsed germ cell tumors.~   "
241481|NCT00393848|"~     The purpose of this study is to determine the effects of two postoperative interventions~     designed to preserve muscle protein after major hip or knee surgery.~   "
241482|NCT00393835|"~     To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or~     Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the~     SR formulation.~   "
241483|NCT00393822|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin~     (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral~     mucositis in subjects with stage 2B and 3 locally advanced, colon cancer receiving~     chemotherapy as an adjuvant treatment for their disease.~   "
241497|NCT00393640|"~     The purpose of this study is to determine whether early start of either breastfeeding or~     breast milk expression may positively affect milk production later in lactation.~      120 breastfeeding mothers will be recruited and randomized into 4 groups (2 groups with~     preterm deliveries) and 2 groups with term deliveries. One group will be given a breast pump~     to pump early and regularly. the second group will be encouraged to breastfeed in response to~     baby's cues. Breast milk samples will be collected at the end of a week.~   "
241486|NCT00393783|"~     The purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and~     stimulates an immune response.~      The immune system consists of different kinds of cells and substances which help fight~     against infections and inflammation in the body. These antibodies and T-cells are part of the~     immune system that may also help to fight against tumor cells. One way to make antibodies and~     stimulate T-cells is to inject the patient with a preparation which contains material that~     may stimulate the immune system. This process is called an immunization. We are trying to~     immunize the patient against HER2/neu. In order to participate in this trial, the tumor must~     have a large amount of HER2/neu on its surface. The injection that the patient will receive~     in this trial is a piece of DNA made in bacteria which contains the gene for rat HER2. DNA is~     material which contains the information needed to produce many substances in the body. The~     HER2 gene encodes for a protein known as HER2.~   "
241487|NCT00393770|"~     Decreased insulin sensitivity (e.g. insulin resistance) is a hallmark and a major pathogenic~     factor of type 2 diabetes. It is the key factor of the metabolic syndrome - a cluster of~     arterial hypertension, obesity, impaired glucose tolerance, dyslipidemia, coagulation~     abnormalities,albuminuria and increased cardiovascular risk - that may precede or accompany~     type 2 diabetes.~      Insulin function and the abnormalities associated with insulin resistance, may have a major~     role in preventing type 2 diabetes and, in the long-term, diabetes micro- and macrovascular~     complications. Carnitine is involved in lipids and carbohydrates metabolism and~     acetyl-L-carnitine(ALC), an intramitochondrial carrier of acylic group, may modulate cell~     fuel substrate utilization. Studies found that carnitine may improve insulin sensitivity and~     glucose disposal in healthy subjects and in patients with type 2 diabetes. A recent study~     also found that a primed constant infusion of acetyl-L-carnitine (ALC) may increase glucose~     utilization in type 2 diabetic patients, possibly restoring the glycogen synthase activity.~      Thus, we designed the Acetylcarnitine in insulin resistance study, a pilot,~     sequential,longitudinal study aimed to assess whether acetyl-carnitine may improve insulin~     function and lipid profile in patients at increased risk of type 2 diabetes.~   "
241488|NCT00393757|"~     The purpose of this study is to see why malaria epidemics occur in highland areas in Kenya. A~     better understanding of factors contributing to malaria may be necessary for malaria vaccine~     planning. These factors include interactions between age, where malaria is passed from~     mosquitoes to people, immune system (how the body fights infection) responses and other~     factors that contribute to malaria in epidemic-prone areas. About 6400 people from the~     villages of Kapsisiywa and Kipsamoite will participate. Study procedures will include in home~     surveys, which will involve a census and an interview by researchers. Blood samples and~     smears will be collected from some volunteers in both communities to understand how the body~     protects itself from malaria and to check for malaria parasites. Twice each month, random~     houses will be selected from 3 places in the village to measure the number of mosquitoes in~     the home. Participants may be involved in the study for up to 4 years.~   "
241489|NCT00393744|"~     The primary objective of this study is to demonstrate the non-inferiority, at the assessment~     visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI)~     administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of~     tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.~   "
241490|NCT00393731|"~     The goal of this study is to compare the vaginal delivery rates in women undergoing induction~     of labor with an unripe cervix between oxytocin induction alone and preinduction cervical~     ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the~     time intervals to delivery between the two methods.~   "
241491|NCT00393718|"~     This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic~     control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after~     24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24~     weeks followed by a 28 week extension period, in total 52 weeks.~   "
241492|NCT00393705|"~     Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic~     control while treated with combination of premixed insulin analogue formulations twice daily~     and metformin will be randomly assigned to follow one of two insulin treatment strategies~     used in combination with metformin administration. The aim of the trial is to try to achieve~     optimal metabolic control and explore full therapeutic potential of the strategies, patients~     in both arms will follow progressive insulin dose titration algorithms for 16 weeks.~   "
241493|NCT00393692|"~     The purpose of this study is to define phenotypic variations in atrophic Age-Related Macular~     Degeneration (AMD) and to identify predictive factors for disease progression based on fundus~     autofluorescence imaging.~   "
241494|NCT00393679|"~     The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations~     (ACT) [amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ),~     artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate] for single and~     repeat treatments of uncomplicated malaria in children. Safety will be determined by~     registering adverse events and grading, laboratory, and vital signs evaluations. Their~     incidence will be compared between the different study arms.~      TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of~     the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap~     plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A~     formal amendment has been submitted to all the concerned ECs and competent authorities. The~     leading EC approved the amendment on 2nd June 2008.~      TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and~     because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment~     in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been~     submitted to all the concerned ECs and competent authorities.~   "
241495|NCT00393666|"~     Our study examines which different brain regions are involved in child absence seizures and~     how they are related to attention and cognition.~   "
241496|NCT00393653|"~     The purpose of this study is to evaluate whether a novel prescription method (N-of-1~     intervention)can be successfully integrated into primary care practices and to examine the~     effects of this prescription method on selected patient health outcomes (e.g.., medication~     compliance, medication costs, symptom management, satisfaction of physician/patient visit,~     etc.) in patients with a uncontrolled or new diagnosis of Osteoarthritis or Chronic Heartburn~     (GERD).~   "
244559|NCT00352924|"~     The Agricultural Health Study (AHS) is a collaborative effort between the National Cancer~     Institute and the National Institute of Environmental Health Sciences. The U.S. Environmental~     Protection Agency and the National Institute for Occupational Safety and Health are providing~     support for a limited exposure assessment effort.~      Initial data collection on a prospective cohort of 89,658 study subjects has been completed~     as of December 1997. Participants completed questionnaires that included items on pesticides~     used, other agricultural exposures, and work practices that modify exposure as well as on~     other activities that may affect either exposure or disease risks (e.g., diet, exercise,~     alcohol consumption, medical conditions, family history of cancer, other occupations and~     smoking history). Phase II of the study (1998-2003) updated information on occupational~     exposures, diet, work practices and medical history by means of a computer assisted telephone~     interview. We also collected buccal cells on sample of 34,000 study participants to assess~     the effect of inheritable polymorphisms and the interaction of environment and genomic~     predisposition.~      The stimulus for this prospective investigation comes from the growing evidence that, despite~     a low mortality overall, farmers experience an excess of several cancers. These excesses have~     been observed in retrospective epidemiological studies among agricultural workers in several~     countries. Excess cancers are observed for the lymphatic and hematopoietic system, connective~     tissue, skin, brain, prostate, stomach and lips. Several of these tumors (brain, NHL,~     multiple myeloma, and prostate) are also increasing in the general population in many of~     these countries. This suggests a common set of exposures may explain the high rates in~     farmers and rising rates in the general population.~      Farmers, their families, and other pest control workers may have contact with a variety of~     potentially hazardous substances including pesticides, solvents, fuels and oils, engine~     exhaust, dust and zoonotic viruses and other microbes. Our cohort study includes all~     registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who~     are farmers. The health effects of pesticide use are the primary focus of the study. The~     influence of other farm exposures are also being evaluated.~      The focus of the phase II follow-up period (2004-2008) is to update exposure information and~     health histories by means of a computer assisted interview and also following the cohort to~     determine disease incidence and mortality. The cohort is being followed through the cancer~     registries within Iowa and North Carolina, the Social Security Administration database, state~     vital statistics offices, National Death Index, and various in-state databases, such as the~     listing of registered pesticide applicators. Individuals who enrolled into the study but who~     are no longer at the address given during enrollment (based on subsequent attempts at follow~     up) have been submitted and will continue to be submitted (through NIOSH) in the standard~     format to the IRS under their Project 057 Taxpayer Address Request Program. Identifying data~     provided to the IRS include only SSN and the first four letters of last name of cohort~     member. IRS provides in return the most current address in IRS records if a match (SSN + all~     four letter of last name) is found. The purpose of this effort is to identify members of the~     cohort who have moved out of state, to enable adjustment of person-years for incidence and~     mortality calculations. Persons who have moved out of state can be followed for vital status~     and cause of death, but not for cancer incidence.~      Continuation of the protocol will provide a valuable epidemiologic resource to help prevent~     cancers in the future by identifying risk factors in the rural/agricultural environment.~     Because more cases of important cancer outcomes occur in this cohort every year, potential~     cancer causes can be evaluated with increased statistical power. Larger number of cases also~     allows for statistical control of confounding factors, making more meaningful conclusions~     about cancer risk, and, for some relatively infrequent cancers, such as the lyphomas and~     leukemias, greater follow-up time is necessary to make any meaningful observations.~   "
241499|NCT00393614|"~     In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children~     who have subclinical epileptiform activity in EEG that increases substantially during slow~     wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not~     have seizures. Hence, according to the definition some children with SSEA do not suffer from~     epilepsy because they do not experience seizures. Many of these children have symptoms such~     as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems,~     tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity~     during slow sleep may act negatively on cognitive functions, language and behaviour in some~     children; even when the spike-wave discharges are less frequent than in CSWS (continuous~     spike-waves during slow sleep).~   "
241500|NCT00393601|"~     The investigator intends to review retrospective de-identified data of patients who have had~     Laparoscopic Radical Cystectomies by the Department of Urology at UCIMC.~   "
241501|NCT00393588|"~     This study will test the ability of magnetic resonance imaging (MRI) to detect damage in~     different parts of the brain in patients with multiple sclerosis and to see if cognitive~     problems in patients can be correlated with the presence of lesions or reduction in the size~     of certain part of the brain. Healthy subjects will also be studied to compare findings in~     patients with those of normal volunteers.~      Healthy subjects and patients with multiple sclerosis who are between 18 and 60 years of age~     may be eligible for this study. Patients must not have severe clinical disability and must~     have been receiving and responding to Interferon beta for at least 6 months prior to~     enrollment. Candidates are screened with a medical history, physical examination, MRI and~     possibly evoked potential testing, which measures the nervous system response to visual,~     auditory and somatosensory stimulation.~      Participants have two MRI scans within 1 week (inclusive of the one performed for screening).~     MRI uses a magnetic field and radio waves to obtain images of body tissues and organs. The~     scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the~     subject lies on a table that can slide in and out of the cylinder. Participants will be~     tested with magnet strengths of 1.5 and 3 Tesla; the higher the Tesla, the greater the~     ability to see brain changes. Each scan may last up to 90 minutes. In addition to the MRI~     scans, participants undergo cognitive testing that measures memory and thought processes and~     complete forms that test and quantify fatigue level, stress, anxiety and depression~   "
241502|NCT00393575|"~     Connect to Protect (C2P): Partnerships for Youth Prevention Interventions is a multi-site,~     three-phase project developed by the Adolescent Medicine Trials Network for HIV/AIDS~     Interventions (ATN). The overall goal of the project is to ultimately reduce HIV incidence~     and prevalence in youth 12-24 years old through a community mobilization intervention. This~     protocol (ATN 040) describes part one of Phase III. Part two of Phase III will be submitted~     as a separate protocol (ATN 041).~   "
241503|NCT00393562|"~     This is an open-label cross-over randomized control study comparing the effect of modafinil~     and methylphenidate in patients with Parkinson's disease with excessive daytime sleepiness.~   "
241504|NCT00393549|"~     The purpose of the study is to compare the performance of the NeuroPath automated nerve~     conduction test with the standard of care manual test in the diagnosis of entrapment~     neuropathies.~   "
241505|NCT00393536|"~     The purpose of this study is to find out whether educational visits by Pharmacists, who are~     already employed as advisers in health organisations, improve the prescribing habits of~     primary care doctors.~   "
241506|NCT00393523|"~     To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children~     who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary~     vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed~     hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in~     this study will be either an investigational Merck product (Modified Process Hepatitis B~     Vaccine) or licensed ENGERIX-B vaccine.~   "
241507|NCT00393510|"~     Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent~     elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super~     imposed infections, all contribute towards the chronicity and failure of treatment.~     Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer~     that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like~     to try all methods of healing before accepting amputation.~      Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for~     diabetic patients suffering from chronic foot ulcers may promote healing so that major leg~     amputation can be avoided.~   "
241508|NCT00393497|"~     The purpose of this study is to evaluate the effectiveness of bevacizumab in women with~     lymphedema as a result of previous treatment for breast cancer.~   "
241509|NCT00393484|"~     Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B~     DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain~     reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100~     mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus~     infection.~   "
241510|NCT00393471|"~     To compare the therapeutic and radiographic effects and safety between etanercept,~     methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid~     arthritis.~   "
241511|NCT00393458|"~     This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses~     of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with~     chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either~     indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily,~     or placebo.~   "
241512|NCT00393445|"~     The purpose of this study is to determine the dose of the GLP-1 receptor antagonist~     exendin(9-39) which blocks the insulinotropic action of synthetic GLP-1 by at least 95%.~   "
241616|NCT00392015|"~     The purpose of this study is to determine whether a new investigational malaria vaccine is~     safe, well tolerated and effective against experimental exposure to malaria when given to~     healthy people with no previous exposure to malaria. The vaccine consists of a modified form~     of a relatively common virus, adenovirus, that has been rendered incapable of replicating~     itself and modified to deliver the malaria gene of interest to the body's cells allowing the~     cell to manufacture the protein encoded by the gene and present it to the body's immune~     system in a more natural and presumably effective way.~   "
241513|NCT00393432|"~     This study will determine how the brain learns a new motor task when the subject practices~     the task and watches others perform it (action observation) at the same time.~      Healthy normal volunteers between 18 and 55 years of age may be eligible for this study.~     Candidates are screened with a medical history, general and neurological exam, and a brain~     MRI if one has not been done within 12 months of entering the study. Participants undergo one~     or both of the following experiments:~        1. Effect of Transcranial Magnetic Stimulation on Motor Training and Action Observation~           Subjects participate in at least 12 4-hour test sessions, separated by at least 1 day.~          Each session includes the following:~             -  Functional MRI (fMRI): MRI scanning uses a magnetic field and radio waves to~               produce images of the brain. For fMRI, the subject performs tasks during the scan~               to allow researchers to see brain changes that occur during performance of the~               activity.~             -  Transcranial magnetic stimulation (TMS): For this test, a wire coil is held on the~               scalp. A brief electrical current passes through the coil to stimulate the brain.~               The stimulation may cause a twitch in muscles of the face, arm, or leg, and the~               subject may hear a click and feel a pulling sensation on the skin under the coil.~               During the stimulation, the subject is asked to: 1) perform the training task (make~               brisk thumb movements); 2) watch a video showing the hand of another person~               performing the same task; and 3) perform the task and watch the video at the same~               time, synchronizing his or her movements with those observed in the video.~             -  Surface electromyography: Electrodes are filled with a conductive gel and taped to~               the skin over a hand muscle to measure the electrical activity of the muscle.~             -  Behavioral measurements: Evaluation of learned movement tasks.~             -  Questionnaires to test attention, fatigue and mood before, during and after each~               test session.~        2. Effect of Pharmacological Agents on Motor Training and Action Observation~      Subjects participate in no more than 12 5-hour test sessions, separated by at least 2 days.~     In the course of the 12 sessions, subjects receive each of three medications -~     dextromethorphan, scopolamine and rivastigmine - three times and a placebo (pill with no~     active ingredient) three times. During each session, subjects have TMS measurements,~     behavioral measurements and electromyography as described in experiment 1.~   "
241514|NCT00393419|"~     The purpose of this study is to determine the effect of a comprehensive pharmacy care program~     on medication adherence and persistence, blood pressure, and LDL cholesterol.~   "
241515|NCT00393406|"~     Lifestyle behaviors among women with a family history of breast cancer are likely to be~     influenced by a number of factors, including both objective risk factors and subjective risk,~     or perceived risk. The aims of this mixed method study are twofold and will be explored~     through both quantitative (i.e. secondary survey data) and qualitative data (i.e. personal~     in-depth interviews) derived from the Sister Study, a large epidemiologic study being~     conducted through the National Institute of Environmental Health Sciences, which is~     addressing risk factors for breast cancer in sisters of women who have had breast cancer. The~     quantitative aims include an exploration of lifestyle behaviors and behavioral differences~     between White and African American women, as well as well as an exploration of the~     relationships between lifestyle behaviors (i.e. varying levels of objective risk based on~     Gail model risk scores, medical risk-reducing factors (i.e. use of Tamoxifen or Raloxifene~     and/or prophylactic surgery), as well as additional factors that may be contributors to~     perceived risk. This aim will be addressed using data that have already been collected as~     part of the baseline activities for the Sister Study. The primary qualitative aim is to gain~     a better understanding about perceived risk and the relationship between perceived risk and~     lifestyle behaviors in both White and African American women with a family history of breast~     cancer. This aim requires the collection of new data through in-person interviews with~     between 28 and 40 women, depending on how many interviews are required to achieve data~     saturation.~      The mixed method approach will be based on a complementarity model, which emphasizes the~     use of two different methods to address different aspects of the research problem. Results~     from both methods will become integrated into the discussion of the findings and it is~     expected that this approach will enrich the study and allow for elaboration of the~     quantitative results. The secondary data analysis will be derived from approximately 10,000~     women, initially enrolled in the Sister Study, who are between the ages of 35 and 74 and have~     had at least one sister affected by breast cancer. Women for the qualitative interviews will~     be recruited from a cohort of Sister Study participants residing within North Carolina and~     will include equal numbers of both White and African American women. It is expected that 28~     women will be needed for qualitative data saturati...~   "
241516|NCT00393393|"~     That Hylan G-F 20 may act to protect cartilage from the expected degree of degradation over a~     12 month period in subjects with moderate to marked osteoarthritis of the knee~   "
241517|NCT00393380|"~     The purpose of this study is to determine whether the addition of parathyroid hormone after a~     sequential cord blood transplant will improve engraftment, which is the ability of the~     transplanted stem cells to grow and to successfully begin producing new blood cells.~   "
241518|NCT00393367|"~     The purpose of this study is to determine whether the addition of budesonide inhalation~     suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic~     corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma~     severity more rapidly than standard therapy alone.~   "
241519|NCT00393354|"~     Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back~     pain.~   "
241520|NCT00393341|"~     We propose to quantitate endothelial progenitor cells (EPCs) in early and advanced breast~     cancer patients. Peripheral blood will be drawn from the eligible patients. Different type of~     EPCs will be isolated from the blood and quantitated.~   "
241521|NCT00393328|"~     The purpose of this clinical research study is to assess the bioequivalence of atazanavir~     administered as a single 300 mg capsule relative to two atazanavir 150 mg capsules in healthy~     subjects.~   "
241522|NCT00393315|"~     The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting~     PTCA-balloon in the treatment of in-stent restenoses in native coronary arteries with~     reference diameters between 2.5 mm and 3.5 mm and ≤ 22 mm in length for procedural success~     and preservation of vessel patency in comparison to the Paclitaxel-eluting Taxus™ stent.~   "
241523|NCT00393302|"~     Mother-to-child transmission of HIV is an important but preventable mode of infection.~     Prevention depends on identifying pregnant women infected with HIV and offering medications~     during pregnancy which can dramatically decrease the chances of transmission. Currently~     universal screening of all pregnant women for HIV is recommended in the province of Ontario.~     Unfortunately the rates of screening are still low: estimates place the average rate at 50%~     -60%. We believe that rates in our clinic at the Women's Health Care Centre are significantly~     higher in part because all our patients have a first obstetrical visit. This is an unhurried~     visit with a trained obstetrical nurse who offers pre-test counselling and explores reasons~     why patients refuse testing. We hypothesize that with this system, acceptance rates for HIV~     screening are significantly higher than the provincial average.~   "
241524|NCT00393289|"~     The purpose of the study is to determine the uptake of calcium from fish bone meal from~     salmon and cod in 12 healthy volunteers. A test meal labelled with trace amounts of a~     radioactive calcium isotope (Ca47) will be given after an overnight fast and whole body~     retention of calcium will be measured on day 13, 21, and 24 after the test meal day.~   "
241525|NCT00393276|"~     Infection with either HIV or hepatitis C virus (HCV) affects immune system responses. The~     purpose of this study is to investigate the immune responses to two different vaccine~     formulations in HIV-infected, HCV-infected, and HCV/HIV- coinfected individuals.~   "
241617|NCT00392002|"~     To characterize the burden of disease in GERD patients of prescription therapy'~   "
241618|NCT00391989|"~     The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in~     de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.~   "
242230|NCT00383877|"~     This trial is conducted in China. This trial aims for a comparison of the effect on glycemic~     control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily~     at bedtime as add-on to oral anti-diabetic drug(s).~   "
241526|NCT00393263|"~     Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS~     causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which~     may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop~     vulvar cancer.~      The current gold standard treatment for lichen sclerosus is ultra-potent topical~     corticosteroids. When properly administered, topical ultra-potent corticosteroids help to~     resolve the symptoms of itching and burning and can prevent further vulvar scarring. In~     addition, proper treatment reverses the underlying inflammation of LS, and preliminary data~     shows that the risk of cancer also declines. While effective, topical corticosteroids have~     serious local and systemic side effects that include thinning of the skin, superimposed~     fungal infections, and suppression of the adrenal gland.~      Elidel 1% cream is a new type of medication that has been approved by the FDA for the~     treatment of eczema. In theory, Elidel should also treat LS without the serious side effects~     that accompany corticosteroids. Therefore, this study is designed to compare the~     effectiveness and safety of a topical corticosteroid (clobetasol) versus Elidel 1% cream for~     the treatment of LS.~   "
241527|NCT00393250|"~     This study will examine whether hypnosis can reduce the frequency and intensity of pain in~     patients with sickle cell disease.~      Patients 18 years of age and older with sickle cell disease and a history of pain associated~     with their disease may be eligible for this study.~      Participants are interviewed to assess their frequency and intensity of pain, sleep quality,~     coping strategies, mood and anxiety and are then randomly assigned to study Group A or B (see~     below). All participants are given pain diaries to complete at home and turn in at each~     clinic visit. They undergo the following procedures:~      Group A~      Weeks 1-4: Receive weekly 60-minute hypnosis sessions, in which they are given suggestions~     for relieving pain, reducing anxiety, improving sleep and enhancing their health and~     well-being. The sessions are audio- and videotaped.~      Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.~      Week 6: Receive a DVD player and DVD with instruction on how to perform self-hypnosis. They~     practice hypnosis at home as often as needed, but at least once a day. They record in a pain~     diary in the morning and the evening their amount of pain, medication use, school or work~     attendance, quality and amount of sleep and number of times they use self-hypnosis.~      Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.~      Week 12: Are assessed for how they respond to the hypnosis.~      Group B~      Weeks 1-4: Receive weekly 60-minute sessions of education about sickle cell disease.~      Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.~      Week 6: Turn in their daily pain diaries and receive a DVD player and DVD that contains~     educational materials about sickle cell disease.~      Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.~      Weeks 13-24: Follow the procedures described in weeks 1-12 for Group A.~   "
241528|NCT00393224|"~     In an effort to identify genetic factors linked to the development of nasopharyngeal cancer~     (NPC), the researchers identified and sampled 2,394 individuals from Taiwanese families in~     which two or more relatives had been diagnosed with NPC. Serum from these individuals was~     tested for three anti-Epstein-Barr virus (EPV) antibodies associated with elevated risk of~     NPC. Results indicate that apparently healthy individuals from high-risk families have a~     nearly threefold elevation in their EBV antibody prevalence compared with the general~     population. However, the clinical implications of this finding are not yet understood.~      To clarify the implications, the 2,394 unaffected individuals from the multiplex family study~     will be invited to participate in the current study. Approximately 1,600 individuals are~     expected to participate.~      Participants will have an ear, nose, and throat examination to determine if they have occult~     or symptomatic NPC. Their levels of EBV antibody at the time of initial recruitment will be~     correlated with NPC detection in the period between initial recruitment and the present~     study. Participants will also be asked to complete a brief risk factor questionnaire and to~     donate blood, saliva, a nasopharyngeal swab, nasopharyngeal tissue, and urine for future~     studies.~      Currently, no accepted clinical management protocol exists for screening unaffected members~     from families at high risk of NPC development. Results from this study have the potential to~     significantly impact the clinical management and follow-up of individuals with a family~     history of NPC.~   "
241529|NCT00393211|"~     Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back~     pain.~   "
241530|NCT00393198|"~     The purpose of this study is to assess the bleeding pattern during the last 3 months of the~     first MIRENA® and the first year of the second MIRENA® use.~   "
241531|NCT00393185|"~     This disease is believed to be due to immune cells, cells which normally protect the body,~     but are now destroying the bile ducts in the liver. When the ducts are damaged, bile builds~     up in the liver and damages liver tissue. Over time, the disease can cause cirrhosis and may~     make the liver stop working. This study is designed to examine whether treating patients with~     high dose Cyclophosphamide and Fludarabine (drugs which reduce the function of your immune~     system) and CAMPATH-1H (a protein that kills the immune cells that are thought to be causing~     PBC), followed by return of blood stem cells that have been previously collected from patient~     brother or sister will stop or reverse the disease. The purpose of the Cyclophosphamide,~     Fludarabine and CAMPATH-1H is to decrease immune system. The purpose of the stem cell~     infusion is to restore blood production, which will be severely impaired by the~     Cyclophosphamide, Fludarabine and CAMPATH-1H, and to produce a normal immune system that will~     no longer attack the body.~   "
241532|NCT00393172|"~     RATIONALE: Exercising regularly may lower the risk of breast cancer.~      PURPOSE: This randomized clinical trial is studying how well exercise prevents breast cancer~     in healthy young women.~   "
241533|NCT00393159|"~     This study is designed to check the effect of the use of the ear popper device on serous~     otitis media in children and on the conductive hearing loss accompanying the otitis. It is~     intended that 30 children aged 3-18 years will participate in the study. The inclusion~     criteria are : clinical serous otitis media for a duration of more then 3 months, a~     conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C.~     The children will use the ear popper for 7 weeks. They will undergo otologic examination,~     audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from~     the beginning of the trial. The otologic findings and the audiometry and tympanometry results~     before and after the trial will be compared. We will try to determine whether the use of the~     ear popper in the test group will improve the conductive hearing loss and prevent the need~     for tympanostomy tube insertion.~   "
241534|NCT00393146|"~     This study is designed to look at the safety, tolerability and effectiveness of 28 days of~     dosing of GW856553 in rheumatoid arthritis patients.~   "
241619|NCT00391976|"~     This study assessed time to recurrence of infection with Pseudomonas aeruginosa following~     treatment of the initial infection with tobramycin nebuliser solution. The safety profile of~     the initial tobramycin treatment was assessed during the first 3 months of the study and~     patients were followed until the end of the study, month 27.~   "
241620|NCT00391963|"~     To compare Bispectral index and entropy during maintenance of anesthesia~   "
241535|NCT00393120|"~     This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist~     INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not~     currently on a HAART regimen and have not received any antiretroviral agents for 3 months~     prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered~     orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead~     electrocardiograms, physical examinations and virologic assessments, including viral load,~     viral tropism and CD4+ cell count determinations will be performed at the Screening visit and~     at regularly scheduled visits throughout the study. A blood sample will also be obtained and~     stored to potentially determine the genotype of the CCR5 receptor.~      The primary objectives are:~        1. Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered~          orally, once daily, as monotherapy for 14 days;~        2. Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered~          orally, once daily, as monotherapy for 14 days;~        3. Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when~          administered orally, once daily, as monotherapy for 14 days~   "
241536|NCT00393107|"~     Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the~     FC+R combination.~   "
241537|NCT00393094|"~     Background:~        -  Bevacizumab is a genetically engineered antibody that blocks the growth of new blood~          vessels in tumors. It has shown activity against human brain tumors in laboratory tests~          and human clinical trials.~        -  Irinotecan causes damage to the deoxyribonucleic acid (DNA) in cancer cells so that the~          cells cannot reproduce or repair themselves. It is approved for treating patients with~          colorectal cancer.~        -  Bevacizumab and irinotecan in combination are more effective against colon cancer than~          either drug alone.~      Objectives:~        -  To determine the safety of bevacizumab and irinotecan and any side effects associated~          with the combination of the two drugs when given to patients with high grade gliomas.~        -  To determine if the combination of bevacizumab and irinotecan can help patients with~          brain tumors that have grown after treatment with bevacizumab alone.~      Eligibility:~      -Patients 18 years of age and older who have been treated on National Cancer Institute (NCI)~     trial 06-C-0064 (NCT00271609), Bevacizumab Alone for Recurrent Gliomas, and whose tumor has~     progressed.~      Design:~      Participants receive infusions of bevacizumab and irinotecan through a vein once every 2~     weeks in 4-week treatment cycles, plus the following procedures:~        -  History, physical and neurological examinations every 2 weeks for the first treatment~          cycle and then every 4 weeks~        -  Magnetic Resonance Imaging (MRI) scan of the head every 4 weeks.~        -  Routine lab every week.~        -  Quality-of-life questionnaire every 4 weeks~   "
241538|NCT00393068|"~     The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib)~     further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation~     therapy in patients with operable esophageal cancer.~      Side effects (toxicity) information will also be collected.~   "
241539|NCT00393055|"~     The purpose of the trial is to determine the extent to which daily use of xylitol lozenges~     reduces the appearance of new caries lesions in adults who tend to experience such lesions~     (i.e., caries-active adults).~   "
241540|NCT00393042|"~     The purpose of this study is to evaluate how children and adolescents with Attention Deficit/~     Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant~     medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is~     to evaluate if there are differences in sleep and other side effects, such as changes in mood~     or loss of appetite, which can occur with stimulant medications. A third purpose is to~     determine if there are differences in the characteristics of individuals who respond better~     to either of the medications.~      This research is being done because the investigators do not know if one of these two~     commonly used treatments is better tolerated than the other. Children and adolescents with~     ADHD often have a hard time sitting still, playing quietly, finishing things they start,~     paying attention, waiting their turn, and not distracting others. These medications improve~     these symptoms, but sometimes affect sleep, appetite, or mood.~      It is hypothesized that at effective and frequently prescribed doses, Adderall will be~     associated with insomnia, more stimulant side effects, and decreased tolerability during an~     acute trial relative to Focalin.~   "
241541|NCT00393029|"~     Background:~      The p53 gene normally suppresses tumor growth, but when it is mutated, or damaged, tumors can~     grow unchecked.~      In cancers where the p53 gene has mutated, an increased level of p53(overexpression of p53)~     can be measured in the tumor.~      Objectives To determine whether advanced cancers that overexpress p53 can be treated~     effectively with lymphocytes (white blood cells) that have been genetically engineered to~     contain an anti-p53 protein.~      Eligibility Patients 18 years of age and older with metastatic cancer (cancer that has spread~     beyond the original site) Patient's tumor overexpresses p53 Patient's leukocyte antigen type~     is HLA-A 0201 Design~      Patients undergo the following procedures:~      Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood~     cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory,~     and the anti-p53 protein is inserted into the cells using an inactivated (harmless)virus in a~     process called transduction. Cells collected in the second leukapheresis procedure are used~     to evaluate the effectiveness of the study treatment.~      Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) for 1 week~     to suppress the immune system so that the patients immune cells do not interfere with the~     treatment.~      Treatment with anti-p53 cells. Patients receive an IV infusion of the transduced cells~     containing anti-p53 protein, followed by infusions of a drug called IL-2, which helps boost~     the effectiveness of the transduced white cells.~      Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). Patients are~     evaluated with laboratory tests and imaging tests, such as computed tomography (CT) scans 4~     to 6 weeks after treatment and then once a month 3 to 4 months to determine the response to~     treatment.~      Patients have blood tests at 1, 3, 6 and 12 months and then annually for the next 10 years.~   "
241542|NCT00393003|"~     This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia~     system during the postoperative period.~   "
241543|NCT00392990|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Giving rituximab~     together with combination chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome~     and rituximab together with combination chemotherapy works in treating patients with newly~     diagnosed Burkitt's lymphoma or Burkitt-like lymphoma.~   "
254831|NCT00215397|"~     The purpose of this study is to determine which dose of the investigational drug is the most~     safe and effective in the treatment of asthma compared to the control drug.~   "
241544|NCT00392977|"~     Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse~     neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased~     risk of Mn neurotoxicity because neonatal PN solutions contain high concentrations of Mn.~     This proposal will investigate brain deposition of Mn, a paramagnetic element, by magnetic~     resonance (MR) imaging in preterm and term neonates receiving Mn-supplemented PN and~     gestational age-matched control infants. The goals of this project are to identify neonatal~     populations that are at increased risk of excessive brain Mn deposition based on their~     gestational age, iron status, hepatic function and dietary Mn intake, and to make~     evidence-based recommendations for appropriate Mn supplementation and monitoring of infants~     receiving PN.~   "
241545|NCT00392964|"~     There is substantial, continuing, and unexplained rise in prescribing of proton pump~     inhibitors. It is unknown whether their use in practice has corresponded to their licensed~     indications.~      Although the indications for H2RA or PPI administration in the treatment of acid-related~     diseases and the prevention of gastric mucosal damage have been well defined in the medical~     literature, the perception of benefit from their use frequently tends to be extrapolated to~     all patients in general, leading to an excessive consumption of these drugs in general~     practice.~      To date, however, little has been published with regard to the overall use or misuse of these~     drugs in hospital populations in ischemic heart disease patients as a secondary prevention to~     Aspirin use.~      We will undertake a 6-months retrospective survey (about 1200 patients) to evaluate the use~     of acid-suppressive medications in the general internal medicine ward of Rambam Hospital.~      We will extract all records of prescribing of a proton pump inhibitor within Rambam Hospital~     computerized patients file program (Premetheuos) in period of half year, categorized and~     analyze them using statistical X2 test.~   "
241546|NCT00392951|"~     Treatment for patients with autoimmune destruction of blood cells is poor. The part of the~     body that fights infections is called the immune system and white blood cells (WBCs) are part~     of the immune system. Normally, a person's body creates WBCs to fight infections and~     eliminates WBCs which have stopped helping the body function. Patients with autoimmune~     destruction of blood cells have difficulty eliminating old WBCs. The abnormal WBCs build up~     and can damage other healthy cells, which can lead to anemia, fatigue, jaundice, internal~     bleeding, infection, and cancer. Few effective medications exist for treatment for patients~     with autoimmune cytopenias and those commonly used are fraught with side effects.~     Nevertheless, as scientific understanding of autoimmune diseases has improved, more directed~     and less toxic therapies are becoming available. A number of groups have been studying the~     efficacy of a medication called sirolimus in patients with autoimmune diseases. This medicine~     has been FDA-approved for over 20 years. Sirolimus is a medicine used in children with other~     diseases. Sirolimus works, in part, by eliminating old and abnormal WBCs. Our group and~     others have shown that sirolimus is effective in mice with autoimmunity and in children with~     a rare condition called Autoimmune Lymphoproliferative Syndrome (ALPS). We believe sirolimus~     will help children with autoimmune cytopenias. We believe it will improve their symptoms and~     make them less sick. We propose to study sirolimus in children with chronic and/or refractory~     autoimmune cytopenias.~   "
241547|NCT00392938|"~     RATIONALE: Imaging procedures, such as PET scan, may help doctors predict a patient's~     response to treatment and help plan the best treatment.~      PURPOSE: This clinical trial is studying carbon-11 acetate and fludeoxyglucose F 18 PET scan~     of the bone in patients with metastatic prostate cancer that has spread to the bone.~   "
241548|NCT00392925|"~     This study will evaluate the safety, tolerability, and effect on body weight of leptin,~     injected subcutaneously, in combination with pramlintide, injected subcutaneously.~   "
241549|NCT00392912|"~     Treatment with testosterone can improve performance on tests of spatial ability in men with~     low testosterone levels and Alzheimer's disease. Improved performance on these tests may mean~     an improved ability to get around in one's environment without getting lost or injured. This~     could have a positive impact on both patients and those who care for them. We will~     investigate what areas of the brain are involved in these improvements in spatial ability.~     This will be done using a PET scan, which creates a 3-dimensional image of the brain that can~     allow us to see how the brain functions.~   "
241550|NCT00392899|"~     RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.~     Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this~     case, observation may be sufficient. It is not yet known whether chemotherapy is more~     effective than observation in treating colorectal cancer.~      PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they~     work compared to observation in treating patients with stage II colorectal cancer that has~     been completely removed by surgery.~   "
241551|NCT00392886|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. A bone marrow or~     peripheral stem cell transplant using stem cells from the patient may be able to replace~     blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to~     be given so that more tumor cells are killed.~      PURPOSE: This phase III trial is studying how well giving combination chemotherapy with or~     without etoposide followed by an autologous stem cell transplant works in treating young~     patients with previously untreated malignant brain tumors.~   "
241552|NCT00392873|"~     The purpose of this study is to examine the effects of increased food intake on the menstrual~     cycle and bone health in physically active women who have irregular or absent menstrual~     cycles. This study will examine whether a 12 month period of increased food intake will cause~     menstrual cycles to resume and help bones get stronger.~   "
241553|NCT00392860|"~     The purpose of this study is to test the effectiveness of newly designed ergonomic manual~     wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard~     handrim. It is our hope that the new design of the handrims will help reduce upper extremity~     pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim~     was designed to directly address the shortcomings of standard handrims and to improve the~     standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed~     for individuals who have limited hand function, making it difficult to grasp standard~     handrims.~   "
241555|NCT00392834|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving rituximab together with combination chemotherapy may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy works in treating patients with newly diagnosed, HIV-associated Burkitt's~     lymphoma.~   "
241556|NCT00392821|"~     This study is being done in 2 parts. The first part is to determine the dose of RAD001 that~     should be used in combination with sorafenib. The second part is using the above determined~     dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against~     advanced kidney cancer.~      Participants will be asked to keep a pill diary.~   "
241557|NCT00392808|"~     The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in~     the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to~     assess the interchangeability of the two different vaccines.~   "
241558|NCT00392795|"~     The primary purpose of this proposal will be to identify potentially modifiable risk factors~     of long-term cognitive impairment (i.e. development of delirium and exposure to sedative and~     analgesic medications) in ICU patients. The investigators will quantify the independent~     contribution of these risk factors to the incidence of long-term cognitive impairment,~     controlling for other established risk factors including age, pre-existing cognitive~     impairment, and apolipoprotein E (apoE) genotype. Quantifying the contributions of these~     modifiable risk factors will pave the way for the development of preventive and/or treatment~     strategies to reduce the incidence, severity and/or duration of long-term cognitive~     impairment and improve functional recovery for patients with critical illness.~   "
241559|NCT00392782|"~     RATIONALE: Giving total-body irradiation and chemotherapy, such as fludarabine and thiotepa,~     before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It~     also helps stop the patient's immune system from rejecting the donor's stem cells. When~     healthy stem cells from a donor are infused into the patient, they may help the patient's~     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving antithymocyte globulin and removing the T cells from the donor cells before transplant~     may stop this from happening.~      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in~     treating patients with myeloid cancer or other disease.~   "
241560|NCT00392769|"~     The goal of this clinical research study is to learn if cetuximab can help to control the~     disease in patients who have recurrent endometrial cancer.~      Primary Objective:~      1. To determine the overall disease control rate of cetuximab in patients with progressive or~     recurrent endometrial cancer.~      Secondary Objectives:~        1. To determine the duration of disease control, time to disease progression, and survival~          of this cohort of patients.~        2. To determine the nature and degree of toxicity of cetuximab in this cohort of patients.~        3. To correlate biologic markers with response to therapy if tissue is available.~   "
241561|NCT00392756|"~     The purpose of the study is to examine how Kallmann syndrome (KS) and idiopathic~     hypogonadotropic hypogonadism (IHH) affect reproductive hormones. These disorders are caused~     by a defect in Gonadotropin Releasing Hormone (GnRH) secretion. GnRH is a hormone released by~     a small gland in the brain called the hypothalamus. When GnRH is released, it signals another~     gland in the brain, the pituitary, to secrete the reproductive hormones that influence~     testosterone levels and sperm production.~      This study involves a detailed evaluation and 8-24 hours stay at the hospital.~      In this study, males ages 16 and older with IHH have a detailed evaluation which involves an~     overnight study at the hospital. Some men (18 years and older) may continue on to receive~     treatment with pulsatile GnRH. This treatment replaces the hormone which is absent in IHH and~     results in normalized testosterone and typically is effective in developing fertility.~   "
241562|NCT00392743|"~     A direct comparison of Positron Emission Tomography (PET) (11C-Raclopride) and Single Photon~     Emission Computed Tomography (SPECT) (123I-IBZM) D2 RO measurements would allow GSK to gain~     understanding on the SPECT results obtained with SB773812, and to accurately interpret future~     D2 RO results from either PET or SPECT studies with new compounds.~   "
241563|NCT00392730|"~     Manganese (Mn) is an essential metal required for normal growth and development. However,~     exposure to high Mn levels can be toxic to the brain. The objectives of this project are to~     identify neonatal and young pediatric populations that are at increased risk of excessive~     brain Mn deposition and altered cognitive and motor development based on their dietary~     parenteral Mn exposure, and to make sound and evidence-based recommendations for appropriate~     Mn supplementation and monitoring of infants and young children receiving parenteral~     nutrition (PN). Our studies are designed to test the hypotheses that, compared with unexposed~     age-matched controls, infants and young children receiving prolonged Mn-supplemented PN will~     have increased deposition of Mn in their brains and lower scores on neurodevelopmental,~     cognitive and psychophysiological assessments.~   "
241564|NCT00392717|"~     Visceral obesity is strongly associated with dyslipidaemia (hypertriglyceridaemia, low~     HDL-cholesterol and mildly elevated LDL-cholesterol) and insulin resistance, key~     characteristics of metabolic syndrome (MetS). Recent evidence has clearly established that~     the risk of CVD is increased in subjects with the MetS. The precise reason for this remains~     unclear, but appears to be closely related with dyslipidaemia. Effective management of~     dyslipidaemia is important to reduce the risk of CVD in these subjects.~      Hypothesis: Inhibition of hepatic cholesterol synthesis by statins and triglyceride synthesis~     by fish oils improve lipoprotein metabolism in visceral obese men.~   "
241565|NCT00392704|"~     Two new cancer treatment drugs called targeted therapies will be added to standard treatment~     for head and neck cancer to see if an improvement can be made in the effectiveness of~     treatment for this type of cancer. Treatment will include chemotherapy, radiation therapy and~     targeted therapy taken over a period of 4 months.~   "
241641|NCT00391690|"~     It is the aim of this prospective, single-group, clinical study to assess whether bone~     parameters can be used as diagnostic tools for early detection of bone metastases in patients~     with high risk prostate cancer. The usefulness in monitoring zoledronic acid therapy in~     patients who have developed bone metastases will also be assessed.~   "
241566|NCT00392691|"~     RATIONALE: Giving chemotherapy drugs, such as melphalan, before an autologous stem cell~     transplant helps stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Also, monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan~     and rituximab, can find cancer cells and carry cancer-killing substances to them without~     harming normal cells. Chemotherapy and monoclonal antibody therapy also prepares the~     patient's bone marrow for the stem cell transplant. Giving colony-stimulating factors, such~     as G-CSF, and vinorelbine helps stem cells move from the bone marrow to the blood so they can~     be collected and stored. The stem cells are returned to the patient to replace the~     blood-forming cells that were destroyed by the chemotherapy and monoclonal antibody therapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when~     given together with yttrium Y 90 ibritumomab tiuxetan and rituximab followed by autologous~     stem cell transplant in treating older patients with non-Hodgkin's lymphoma that has relapsed~     or not responded to previous treatment.~   "
241567|NCT00392678|"~     Growing evidence over recent years supports a potential role for low grade chronic~     inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we~     will determine whether salsalate, a member of the commonly used Non-Steroidal~     Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2~     diabetes. The study will determine whether salicylates represent a new pharmacological option~     for diabetes management. The study is conducted in two stages. The first stage is a dose~     ranging study, administering salsalate compared to placebo over three months. The primary~     objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar~     control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes~     (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and~     cardiac risk.~      The second stage is a second trial and posted under alternate registration.~   "
241568|NCT00392665|"~     The main purpose of this research study is to collect information to learn how effective~     erlotinib (tarceva) is in combination with either bevacizumab or sulindac in treating~     patients with squamous cell carcinoma of the head and neck. Erlotinib and bevacizumab are~     targeted therapy drugs that can control tumor growth by targeting specific abnormalities~     sometimes found on cancer cells. Erlotinib targets epidermal growth factor receptor (EGFR),~     and bevacizumab targets vascular endothelial growth factor (VEGF). Sulindac is a~     non-steroidal anti-inflammatory drug (NSAID) that can block G protein-coupled receptor which~     laboratory evidence shows is associated with both cancer cell growth and EGFR activity. The~     bevacizumab being administered in this study is not a commercially marketed formulation of~     the drug. Previous research with head and neck cancer suggest that erlotinib alone has some~     anti-cancer activity. This research study is designed to see how well erlotinib works in~     combination with bevacizumab or sulindac in head and neck cancer.~   "
241569|NCT00392652|"~     This randomized phase I trial is studying the side effects and best dose of diindolylmethane~     in healthy volunteers. Chemoprevention is the use of certain drugs or substances to keep~     cancer from forming, growing, or coming back. The use of diindolylmethane may keep cancer~     from forming. Collecting and storing samples of blood and urine from healthy volunteers to~     study in the laboratory may help doctors learn more about the way a person's body handles the~     drug.~   "
241570|NCT00392639|"~     According to international guidelines, mild therapeutic hypothermia is recommended for~     resuscitated patients after cardiac arrest due to ventricular fibrillation. Whether external~     or internal cooling is superior in terms of prognosis or security remains unknown. The aim of~     this study is to evaluate in a randomized trial the clinical and economical interests of the~     endovascular cooling versus the conventional external cooling for the management of~     hypothermia after cardiac arrest.~   "
241571|NCT00392613|"~     The investigators hypothesis is that in patients with permanent AF lenient rate control is~     not inferior to strict rate control in terms of cardiovascular mortality, morbidity,~     neurohormonal activation, NYHA class for heart failure, left ventricular function, left~     atrial size, quality of life and costs. Lenient rate control is defined as a resting heart~     rate <110 bpm.Strict rate control is defined as a mean resting heart rate < 80 beats per~     minute (bpm) and heart rate during minor exercise < 110 bpm. Patients will be seen after 1,~     2, 3 months (for titration of rate control drugs) and thereafter yearly.~   "
241572|NCT00392587|"~     The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess~     its affects on their COPD disease after 14 days.~   "
241573|NCT00392574|"~     The objective of this pivotal Phase III study is to investigate the safety and efficacy of~     prulifloxacin versus placebo in the treatment of subjects with acute bacterial~     gastroenteritis.~   "
241574|NCT00392561|"~     The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in~     preventing non-melanoma skin cancers.~   "
241575|NCT00392548|"~     Study of the urinary vascular endothelial growth factor (VEGF) levels in patients with~     glioblastoma, receiving standard therapy.~      Hypothesis: that urinary VEGF levels can serve as a predictor of treatment response and~     survival.~   "
241576|NCT00392535|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet~     known which schedule of intensity-modulated radiation therapy is more effective in treating~     patients with prostate cancer.~      PURPOSE: This randomized phase III trial is studying the side effects of three schedules of~     intensity-modulated radiation therapy and compares how well they work in treating patients~     with localized prostate cancer.~   "
241621|NCT00391950|"~     The purpose of this study is to see if giving zoledronic acid three times a year is as~     effective as five times a year, in increasing bone strength in men with prostate cancer. All~     participants will receive the active drug but half will receive drug every 6 months and the~     other half will receive drug every 3 months. Both patient and doctor will know which~     treatment a patient is receiving.~      After 1 year of treatment bone strength will be measured with scans and compared to the~     strength at the start of the study. All participants will stop receiving the drug after 1~     year and will be seen back in the clinic, annually for another 2 years for follow-up.~   "
241642|NCT00391677|"~     This study will evaluate the effectiveness of attention shaping procedures in improving~     attentiveness and learning abilities in people undergoing psychosocial skills training~     treatment for schizophrenia.~   "
241577|NCT00392522|"~     Fiberoptic bronchoscopy may generate pain, anxiety or cough and dyspnea. It may then induce~     discomfort and then run down its yield. Systematic local anaesthesia does not always suffice~     and FOB may be conducted under general anaesthesia. Premixed nitrous oxide and oxygen (MEOPA)~     could be efficient to avoid general anesthesia risks and to reduce organizational costs.~     Nitrous oxide induces anaelgesia and anxiolysis when administered in oxygen at a 50%~     concentration.~      MEOPA is being delivered in France for every short painful medical in-patients procedure~     since 2001. At a concentration of 50% in oxygen, and delivered through a facial mask, it~     produces a conscious sedation useful during endoscopy. MEOPA safety is due to its short term~     effect, which ends 5 minutes after cessation of inhalation. It therefore allows ambulatory~     medicine.~      Two randomized double blind controlled studies were driven in fiberoptic bronchoscopy~     (Fauroux 2004, Atassi 2005) and showed its efficacy on pain control and sedation.~      We will perform our Study to estimate MEOPA efficacy in term of pain control (Visual Analogic~     Scale (VAS)), anxiety control (COVI Scale), cough and number of general anaesthesias,~     comparing FOB under MEOPA and Oxygen (double blind, randomized, placebo-controlled study.~   "
241578|NCT00392509|"~     This study will treat patients with such severe lower leg ischemia or vascular compromise~     that they have pain at rest. The goal is to compare treatment of the patient's painful~     disorder by injecting cells into the calf of the leg and testing for circulatory improvement.~     A treatment will given at random to two groups and will be injection into the calf muscle~     with ALD-301 (specially processed stem and progenitor cells) from the patient's own bone~     marrow, or with cells processed by more routine that minimally purifies the cells. The study~     goal is to see if the ALD-301 cells are more effective in generating new small blood vessels~     to improve the circulation to the affected leg.~   "
241579|NCT00392496|"~     This phase II trial is studying how well sunitinib works in treating patients with relapsed~     or refractory diffuse or mediastinal large B-cell lymphoma. Sunitinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the cancer.~   "
241580|NCT00392483|"~     The evaluate the use and diffusion of an E-learning programme in Diagnostic Evaluation of~     Dementia among General Practitioners (GPs) in Denmark.~      The hypothesis are:~        1. The GPs do not use the guided instructions~        2. The GPs using the programme are more frequently younger GPs.~        3. GPs working in rural areas will use the programme more frequently~   "
241581|NCT00392470|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in~     chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. Giving radiation therapy together with irinotecan and cetuximab before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when~     given together with cetuximab and radiation therapy in treating patients who are undergoing~     surgery for stage III or stage IV rectal cancer.~   "
241582|NCT00392457|"~     The purpose of the research study is to learn more about the regulation of reproductive~     hormones in adult men. We would like to understand what role testosterone and estradiol play~     in controlling the release of LH (lutenizing hormone) and FSH (follicle stimulating hormone).~     Testosterone and estradiol come from the testes, and LH and FSH are released from a gland in~     the head called the pituitary.~      Men involved in the study will have detailed evaluations that involve overnight stays in the~     hospital and frequent blood sampling. The men in the study will also be receiving medications~     that affect the levels of various hormones in the body. This will allow the researchers to~     learn how various hormones influence each other. Men that participate in the study will~     receive medical evaluations and monetary compensation. Information gathered from this study~     will help in the development of new treatments for infertility and potentially new hormonal~     forms of contraception.~   "
241583|NCT00392444|"~     This phase II trial is studying how well sunitinib works in treating patients with advanced~     malignant mesothelioma of the pleura. Sunitinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for their growth.~   "
241584|NCT00392431|"~     Our hypothesis is that episodic amiodarone treatment (i.e. amiodarone treatment 1 month prior~     until 1 month after cardioversion) is associated with a lower morbidity and a higher quality~     of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is~     still effectively suppressed. The latter means that at the end of the study permanent atrial~     fibrillation is prevented in comparable percentage of patients (70%) in both treatment~     strategies. However, this will be accomplished at the cost of a higher number of electrical~     cardioversions (2-3) in the episodic treatment group compared to the continuous treatment~     group.~   "
241585|NCT00392418|"~     Millions of people worldwide are affected by iron deficiency anemia (IDA). IDA is a~     widespread serious public health problem, especially for infants in developing countries~     mainly because of inadequate intake of iron due to the poor bioavailability of dietary iron~     in predominately cereal based diets. One of the ways to combat iron deficiency anemia is by~     supplementation to targeted populations. Although iron drops have been used, they have been~     largely unsuccessful in reducing the prevalence of anemia because of compliance, distribution~     and supply issues. Sprinkles® are a new approach to iron delivery that is as efficacious as~     iron drops and more acceptable. For Sprinkles® to be implemented into nation-wide programs as~     a sustainable alternative to current iron supplementation approaches, an optimal model of use~     and distribution for Sprinkles® needs to be established. By comparing daily versus flexible~     use of Sprinkles® (60 sachets over 60, 90 and 120 days) among infants and young children aged~     6-24 months, the primary objectives are to study the effect of the three administration~     models of Sprinkles® on changes in:~        1. hemoglobin concentration; and~        2. compliance or adherence to the intervention.~      ii. The secondary objective of this study is to determine the acceptability of each of the~     three intervention models.~      We hypothesize that adherence will be greater and hemoglobin concentration response will be~     higher in those given 'flexible' instructions to use all of the Sprinkles® supplied over a~     specific period of time compared to those given strict instructions for daily use.~   "
241586|NCT00392405|"~     This will be a randomized controlled trial closely following the original protocol in the~     previous study published in JAMA 2004 by Merten et al. Patients will be randomly assigned to~     one of two treatment groups. Treatment group A will receive 1cc/kg/hour of 0.9% normal saline~     at least 2 hours prior to study beginning and will be continued during and for 6 hours post~     contrast. Treatment group B will receive 3cc/kg of sodium bicarbonate solution for one hour~     prior to procedure then drip rate will be decreased to 1cc/kg/hour during and for 6 hours~     post procedure. The sodium bicarbonate solution will be made by adding 3 amps of bicarbonate~     to 1L of D5W. Patients in both treatment arms weighing >110kg the initial fluid bolus and~     drip will be limited to those patients weighing 110kg. In both treatment arms, diuretics will~     be held before and after contrast administration on the day of the study. BMP will be checked~     the day of, 24 and 48 hours post contrast administration. The greatest change in all readings~     will be used for treatment comparisons. Contrast induced nephropathy will be defined as a~     change in serum creatinine of more than 25% from baseline and/or 0.5mg/dL. Urinary pH will~     also be measured on first spontaneous void following bolus. Vital signs including blood~     pressure and oxygen saturation will be documented every 4 hours to monitor patients closely~     for signs and symptoms of volume overload~   "
241587|NCT00392392|"~     This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and~     carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers~     demonstrating HER2 gene amplification. It is hoped that this novel combination will result in~     increased pathologic response rates that will translate into long term outcome improvements~     in HER2 positive patients with locally advanced breast cancer.~   "
241588|NCT00392379|"~     This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The~     independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching~     placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6~     months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or~     matching placebo.~   "
241589|NCT00392366|"~     The purpose of this study is to determine if the, MR guided, laser interstitial thermal~     therapy (LITT) treatment technique can be safety and efficiently used for the human liver~     metastasis~   "
241590|NCT00392353|"~     This phase I/II trial studies the side effects and best dose of vorinostat and azacitidine~     and to see how well they work in treating patients with myelodysplastic syndromes or acute~     myeloid leukemia. Vorinostat may stop the growth of cancer or abnormal cells by blocking some~     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work~     in different ways to stop the growth of cancer or abnormal cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving vorinostat~     together with azacitidine may kill more cancer or abnormal cells.~   "
241591|NCT00392340|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, vincristine, and doxorubicin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving topotecan together with vincristine~     and doxorubicin works in treating young patients with refractory stage 4 neuroblastoma.~   "
241592|NCT00392327|"~     This randomized phase III trial studies different chemotherapy and radiation therapy regimens~     to compare how well they work in treating young patients with newly diagnosed, previously~     untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine~     sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Isotretinoin may help chemotherapy work better by making tumor cells more~     sensitive to the drugs. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known~     which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.~   "
241593|NCT00392314|"~     Recently published studies demonstrated very high event free survival for patients with a~     normal interim PET/CT and a high hazard ratio for progression of an interim positive~     (pathological)study. These findings strongly support the integration of interim PET as a~     decision point for adjustment of chemotherapy.This study use the minimal therapy considered~     safe according to the predefined risk factors for patients with interim negative PET. Those~     with pathologic interim study considered as higher risk patients will have dose escalation of~     therapy.remission rate ,event free survival and overall survival will be evaluated.~   "
241594|NCT00392301|"~     The purpose of this research study is to discover whether instruments widely used in skin~     research can be used to measure wound healing in split thickness skin graft donor sites and~     whether these instruments can detect differences in healing when two different dressing~     products are used.~   "
241595|NCT00392288|"~     Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg~     twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.~      Secondary objective: To assess the safety and tolerability of ciclesonide.~   "
241596|NCT00392275|"~     Based on previous results with eyes without filtering blebs, the aqueous concentrations of~     ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either~     topical or topical plus oral administration.~   "
241597|NCT00392262|"~     The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in~     hypertensive patients not responding to treatment with amlodipine or felodipine alone.~   "
241622|NCT00391937|"~     The purpose of this study is to compare the articular surface replacement (ASR) prosthesis~     placed by the conventional positioning method and the ASR prosthesis placed by 'computer~     assisted surgery' (CAS) in variation between pre planned position of the femoral component~     and the actual position of the femoral component of the prosthesis. The hypothesis is that~     this variation is larger with the conventional positioning method than when CAS is used.~   "
241623|NCT00391924|"~     The purpose of the study is to examine whether dehydroepiandrosterone (DHEA) administration~     improves fatigue and general well-being in patients with systemic lupus erythematosus or~     primary Sjögren's syndrome~   "
241643|NCT00391664|"~     The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer~     survivors.~   "
241598|NCT00392249|"~     Patients suffering from Schizophrenia and their families often suffer from poor care because~     of ignorance about the disorder especially in economically developing countries. Although~     antipsychotic medication is effective in reducing relapse rate, 30-40 percent of patients~     relapse within one year and 40-60 percent relapse within 2 years after discharge from 1st~     hospitalization even if they are receiving maintenance medication.~      Although antipsychotic medications are the mainstay of the treatment for schizophrenia,~     patients with schizophrenia benefit more from combined use of antipsychotic drugs and~     psychosocial treatment than pharmacotherapy alone in delaying or preventing relapse or~     reducing hospital days. It is also less costly than standard treatment and suitable for~     psychiatric rehabilitation.~      Although there are now a number of studies from western countries and a randomized controlled~     trial from china which have led to increase enthusiasm about psychosocial treatment for~     schizophrenia but question remains about comparative benefit of treatment methods and~     additional methods of multiple treatment. In developing countries there is need for further~     studies in which integrated treatment of pharmaco-therapy and psycho-education is instituted~     and compared with treatment as usual.~      Realizing the need for maintaining the compliance and continuity of treatment, department of~     psychiatry has started a program called Supervised Treatment of Outpatient Schizophrenia.~     This study aims to evaluate the effectiveness of Supervised Treatment versus the usual care~     provided in the outpatient.~   "
241599|NCT00392236|"~     This study will determine whether using a pager improves medication adherence in people with~     schizophrenia.~   "
241600|NCT00392223|"~     The primary objective is to evaluate the clinical efficacy of azithromycin microspheres~     treatment in outpatients with moderate to severe inflammatory acne compared with first line~     treatment minocycline after 8 weeks of therapy~   "
241601|NCT00392210|"~     After gynecologic surgery, it may be difficult to void (urinate). This problem is usually~     short-term with normal function returning within a few days to a few weeks. For this reason,~     patients may require drainage of their bladder with a catheter immediately after surgery.~     Currently in our office, we use two different tests to see how well you are able to urinate~     and how quickly the catheter can be removed. The purpose of this study is to see which~     voiding test is better after gynecologic surgery.~   "
241602|NCT00392197|"~     The objective of this study is to examine the effects of aripiprazole on glucose metabolism~     in schizophrenic patients without hyperglycemia and diabetes mellitus or any history thereof.~   "
241603|NCT00392184|"~     The purpose of this study is to determine whether accelerated partial breast irradiation~     (APBI) with multi-catheter brachytherapy is safe and effective.~   "
241604|NCT00392171|"~     The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE~     study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense~     temozolomide (50 mg/m^2) for up to 12 months may overcome resistance and be effective in the~     management of adult patients with malignant glioma who have failed following at least 2~     cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200~     mg/m^2).~   "
241605|NCT00392158|"~     To compare manual administration of propofol and remifentanil and dual closed-loop using~     bispectral index as the control variable during anesthesia~   "
241606|NCT00392145|"~     This study will look at children with dehydration secondary to gastroenteritis requiring IV~     rehydration and determine whether the proportion rehydrated after two hours is greater in the~     children who receive rapid intravenous rehydration (RIVR) or in the children who receive~     standard IV rehydration.~   "
241607|NCT00392132|"~     The Infectious Disease Society of America has recently recommended that patients with Human~     Immunodeficiency Virus (HIV) be screened for kidney disease on a regular basis. Screening~     involves non-invasive urine and blood test and a screening program has already been initiated~     here in the University of Mississippi HIV clinic. This study looks at the effect of this new~     screening program. Our Hypothesis is that screening for kidney disease is a cost effective~     and important addition to the care of patients with HIV.~   "
241608|NCT00392119|"~     The purpose of this study is to determine if the stereotactic, MR guided, laser interstitial~     thermal therapy treatment technique can be safety and efficiently used for human brain~     metastasis and primary brain tumors.~   "
241609|NCT00392106|"~     The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is~     effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best~     medical therapy with FDA approved antiarrhythmic drugs.~   "
241610|NCT00392093|"~     Hypothesis, HRT does not increase the risk of lupus activity exacerbation, it is effective~     for the relief of menopausal symptoms and improves bone mineral density.~      Double-blind, randomized, placebo controlled clinical trial.~      Objectives~        1. Determine the effect of HRT on disease activity, menopausal symptoms, bone mineral~          density, lipid profile, and mammographic parenchymal density in menopausal women with~          SLE.~        2. Determine the incidence rate of major side effects of HRT in menopausal women with SLE.~      Outcome Measures~        1. Primary outcome will be global disease activity throughout the follow-up period.~        2. Incidence of lupus flares, time to the first flare, changes in SLEDAI values from~          baseline at each follow-up visit, maximum disease activity, lupus treatment,~          hospitalizations, thromboses, and deaths.~      Menopausal symptoms and depression will be assessed utilizing the Greene Climacteric Scale~     questionnaire and the Beck Depression Inventory.~      Bone mineral density of lumbar spine and hip will be performed with dual energy x-ray~     absorptiometry. In addition, blood and urine samples to measure biochemical markers of bone~     turnover.~      Estradiol levels, lipid profile,coagulation tests, cervical cytology examinations,~     mammography.~      Inclusion Criteria: (Any two of the following criteria)~        1. Amenorrhea of 6 months or more~        2. Serum FSH level of 30 IU/L or more~        3. Menopausal symptoms~        4. Age 48 years or older.~      Exclusion Criteria:~        1. Women older than 65 years~        2. Severe lupus activity at baseline~        3. Use of estrogens within 3 months of the screening visit~        4. Serum creatinine of 2.0 mg/dL or more~        5. Hypertriglyceridemia 500 mg/dL or more~        6. Metabolic bone diseases~        7. Liver disease~        8. Untreated hyperthyroidism~        9. Recent thrombosis~       10. Malignancy~       11. Endometrial hyperplasia~       12. Undiagnosed uterine bleeding~       13. Cervical dysplasia.~      Subject allocation Random assign, using a computer-generated randomization list to:~     Conjugated equine estrogens 0.625 mg/day plus 5 mg/day of medroxyprogesterone acetate p.o.~     for the first 10 days per-month, or biologically inert placebo.All women will receive 1200 mg~     of calcium carbonate and 800 IU of vitamin D, daily.~      Follow-up procedure All patients will be evaluated by a rheumatologist and a reproductive~     health specialist at baseline,1,2,3,6,9,12,15,18,21, and 24 months.~      Rheumatic evaluation:~        1. General information (baseline).~        2. Lupus activity (every visit).~        3. Medications: (every visit)~      Gynecological evaluation:~      Onset of symptoms since the previous visit using a standardized questionnaire. In addition, a~     gynecological examination will be performed.~      Criteria for early termination of the study:~      A patient will be discontinued from the study whenever any of the following criteria would be~     present:~        1. Development of severe lupus activity (SLEDAI > 30).~        2. Development of any putative complication to hormone therapy.~        3. Development of any other severe complications due neither to SLE nor hormone therapy.~        4. Need prolonged immobilization.~      Statistical analysis:~      Between-group comparisons of lupus activity, maximum SLEDAI, and change in SLEDAI score from~     baseline at each follow-up visit. Incidence-density rates of flares with relative risk and 95~     percent confidence intervals.Probability of flares throughout the study using life-table~     analyses and log-rank test.~      Climacteric symptoms as the mean value of the Green’s scale score at baseline and at each~     follow-up visit, between-group and intra-group. Bone mineral density as the mean value at~     baseline, 12 and 24 months, between and intra-group.~      The proportion of patients in each group who develop secondary effects, as well as the number~     who quit the study during the follow-up period.~      Continuous variables will be compared using Student's t-test, and categorical variables using~     chi-square or Fisher’s exact test. Within-group comparisons will be done using the Wilcoxon~     signed-rank test. P values will be two-sided. Analyses will be conducted by the~     intention-to-treat method.~   "
241611|NCT00392080|"~     CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the~     treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to~     evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer~     gastrointestinal ulcers compared to patients treated with naproxen and placebo.~   "
241612|NCT00392067|"~     To compare the efficacy and safety of two different dose combinations of LEO19123~     (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of~     patients with atopic dermatitis~   "
241613|NCT00392054|"~     The purpose of this study is to determine whether catheter-based pulmonary vein isolation is~     superior to antiarrhythmic drugs as first line therapy in patients with symptomatic~     paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of~     antiarrhythmic drugs.~   "
241614|NCT00392041|"~     The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other~     symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will~     report greater improvement in total sleep time, sleep quality, pain, fatigue, physical~     functioning, and emotional distress than will those receiving placebo.~   "
241615|NCT00392028|"~     The aim of the study is to determine the penetration levels of ertapenem into bone tissues in~     patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing~     amputation, and to correlate theme to the concentration of the drug in blood and other soft~     tissues~   "
241638|NCT00391729|"~     The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2~     mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.~   "
241639|NCT00391716|"~     Gabapentin treatment for alcohol dependence~   "
241624|NCT00391911|"~     Rhabdomyolysis has many causes including trauma, muscle crush injuries, lack of blood supply~     to an arm or leg, burns, seizures, drugs and hereditary disorders. Rhabdomyolysis causes the~     breakdown of muscle cells and the release of a molecule called myoglobin. Myoglobin is very~     harmful to the kidneys and can lead to kidney failure.~      Continuous dialysis has been shown to remove the myoglobin molecule from the blood in~     patients with rhabdomyolysis. N-Acetylcysteine (NAC) has been used in patients receiving~     contrast dye for x-rays and has shown less worsening of kidney function compared to patients~     not receiving NAC.~      Early and aggressive treatment of patients with rhabdomyolysis with standard therapy,~     continuous dialysis and a drug called N-acetylcysteine (NAC) may prevent the development of~     acute kidney failure. Patients who develop kidney failure from this disorder are often~     critically ill and have a much higher chance of not surviving than those who do not develop~     kidney failure.~      The purpose of this study is to determine if the use of NAC and Continuous Veno-Venous~     hemo(dia)filtration (CRRT)early in the course of rhabdomyolysis (in addition to standard~     therapy)decreases the chance of developing acute renal failure~   "
241625|NCT00391898|"~     The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in~     patients with Parkinson's disease and early wearing-off with levodopa~   "
241626|NCT00391885|"~     This study compares the manual administration of propofol and remifentanil and their delivery~     using a combined closed-loop anesthesia system, entropy of the EEG being the controller.~   "
241627|NCT00391872|"~     Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications~     work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment~     for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both~     heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by~     the formation of a blood clot in an artery that partially or totally blocks the blood supply~     to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine~     which drug, when either is used in conjunction with aspirin, is better at reducing deaths~     from vascular causes, future heart attacks and/or strokes in patients with ACS.~   "
241628|NCT00391859|"~     Osteoarthritis (OA) is a major public health concern. Currently, there are at least 3 million~     Canadians afflicted with this condition with a 50% increase predicted by 2020. It is~     estimated that 85% of Canadians are afflicted with OA by age 70. As such, using the current~     health care structure, it is doubtful that the health system can keep pace with this~     increasing demand. Alternative health care delivery strategies must be investigated.~      The purpose of this study is to assess if a pharmacist-initiated intervention for individuals~     with knee pain with a high likelihood of knee OA will lead to an improvement in the quality~     of care for these individuals.~      We are hopeful that results of this study will show better management of knee osteoarthritis~     by a pharmacist-initiated intervention (which means that it is the pharmacist who will start~     the process for an intervention that includes exercise and an educational program when~     compared to no intervention. If this is the case, by implementing the proposed intervention~     program, subjects could be diagnosed earlier, the burden of illness on individuals could be~     diminished through an appropriate intervention program, and economic savings could be~     embraced.~      Hypothesis: Community pharmacists can identify patients with likely knee OA and initiate a~     multidisciplinary intervention that will improve quality of care and outcomes.~   "
241629|NCT00391846|"~     The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms~     and signs is more effective than treatment guided by clinical symptoms and signs alone in~     patients with HF and left ventricular systolic dysfunction~   "
241630|NCT00391833|"~     We investigate the clinical efficacy of Panax ginseng in Alzheimer’s disease (AD).~   "
241631|NCT00391820|"~     Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with~     placebo (a sugar pill) for the treatment of chronic constipation.~   "
241632|NCT00391807|"~     This is a non-comparative study. The primary objective of the study is to assess the efficacy~     of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are~     to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of~     the product.~   "
241633|NCT00391794|"~     The purpose of this study is to evaluate the impact of an Early Stage Memory Loss Support~     Group (ESSG) and Education Seminar (ES) on quality of life, mood, social support, distress~     about memory loss, and interpersonal relationships of memory loss participants and their~     caregivers.~   "
241634|NCT00391781|"~     The aim of this study is to compare between body-temperature to room-temperature contrast~     media used during hysterosalpingography. We hypothesize that warmed medium will reduce pain~     associated with the procedure.~   "
241635|NCT00391768|"~     The purpose of this study is to learn how to treat influenza in children less than 2 years of~     age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age~     and older with influenza. Researchers want to learn more about the activity of Tamiflu® in~     the body to determine a dose of that is safe, well-tolerated, and effective in young children~     with influenza. Children less than 24 months of age with confirmed influenza will receive~     Tamiflu® 2 times a day for 5 days. Older participants will be enrolled first and younger~     children will be enrolled after the safety data is reviewed for older participants. Study~     procedures include blood samples, swabs from inside the nose, and body and nervous system~     evaluations. Participants may be involved in study related procedures for up to 37 days.~   "
241636|NCT00391755|"~     To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor~     agonist used for insomnia, as a migraine prophylactic agent.~   "
241637|NCT00391742|"~     In a randomized controlled trial, patients recruited in general practices and fulfilling~     criteria for alcohol dependence, alcohol abuse, at-risk drinking or binge drinking will be~     allocated to three conditions: (1) Stepped Care intervention (SC): up to 4 interventions~     depending on the success of the previous intervention (assessed by alcohol consumption and~     self-efficacy) which start with a minimal intervention (written feedback and manuals) and are~     followed by more intensive interventions (counseling) in case of no success, (2) Fixed Care~     intervention (FC): A fixed number of counseling sessions plus written feedback and manuals,~     and (3) a control group (CG) booklet on health behavior. Outcome assessment will be conducted~     in all three groups after 12 months. The hypothesis is that SC and FC do not differ in~     effectiveness but SC is more economic.~   "
241644|NCT00391651|"~     The purpose of this research study is to determine what the cure rates are with a 5 day~     course of nitrofurantoin versus the more standard 3 day course of~     trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and~     what length of therapy is best for treatment of UTI, taking into account the problem of~     antibiotic resistance.~      Procedures subjects will undergo once they have read and signed the consent are:~      Questions about their medical and sexual history and current symptoms of UTI. They will be~     asked to provide a urine sample and then randomly assigned to one of the two treatment~     groups.~      will be obtained at each visit. If they were assigned to the nitrofurantoin treatment~     regimen, they will also be asked to collect a urine sample at home on the third day. If the~     subject develops recurrent urinary symptoms or does not have resolution of symptoms after~     completing the initial treatment course, they will be asked to return to the clinic and~     provide another urine sample for analysis. They will then be treated with another standard~     antibiotic at no cost to them and will be withdrawn from the study at that time.~      The study population is women ages 18-45 with acute symptoms of a UTI without a history of~     UTI in the past 6 weeks.~   "
241645|NCT00391638|"~     HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a~     non progressive liver infection and a better clinical outcome. However, the rate of HBe~     seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and~     emtricitabine. This study will evaluate the efficacy and the safety of a one-year~     Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and~     emtricitabine without reaching HBe seroconversion.~   "
241646|NCT00391625|"~     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme~     glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside~     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ~     system dysfunction. The purpose of this study is to evaluate the long term safety of enzyme~     replacement therapy with DRX008A (VPRIV®, GA-GCB; velaglucerase alfa) in patients with type 1~     Gaucher disease.~   "
241647|NCT00391612|"~     This is an international clinical research study evaluating the safety and effectiveness of a~     new procedure called airway bypass. The goal of this research is to see if airway bypass can~     relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and~     reducing shortness of breath in patients with severe homogeneous (diffuse) emphysema. EASE~     stands for Exhale Airway Stents for Emphysema.~   "
241648|NCT00391599|"~     Enemas are not anymore used routinely before vaginal deliveries.The intention of this study~     is to elucidate whether there is a benefit in routine use of enema before cesarean section.~   "
241649|NCT00391586|"~     This study was conducted to compare the activities of erlotinib to that of intravenous,~     platinum-based therapy in the treatment of non-small cell lung cancer (NSCLC). The goal of~     this trial was to demonstrate clinical equivalence of erlotinib to platinum-based frontline~     therapy, compared to historical controls.~   "
241650|NCT00391573|"~     To compare the use of polyglactin sutures versus nylon sutures for conjunctival autograft~     suturing in pterygium surgery.~   "
241651|NCT00391560|"~     This is a Phase II trial designed to determine the efficacy and safety of perifosine in~     patients with leukemia who develop progressive disease or recurrence while receiving therapy.~   "
241652|NCT00391547|"~     The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human~     subjects for treatment of Gingivitis.~   "
241653|NCT00391534|"~     This study is intended to investigate the safety and efficacy of a novel formulation of~     oxcarbazepine that is released more slowly than the current formulation. The study medication~     will be used as a treatment against partial epilepsy.~   "
241654|NCT00391521|"~     This is a Phase I trial. Some specific protocol information is proprietary and is not~     publicly available at this time. Full information will be provided to trial participants.~   "
241655|NCT00391508|"~     Peristomal skin complications are thought to be common but the exact frequency and cause of~     these complications are unknown. We have sought to document the incidence of cutaneous~     peristomal problems and to find risk factors that might contribute to peristomal~     complications.~   "
241656|NCT00391495|"~     The aim of this study is to investigate the inflammatory response in children with this~     disorder.~   "
241657|NCT00391482|"~     The purpose of this study is to determine whether a six-session, small group behavioral~     intervention based on peer-volunteer activism is effective in (1) decreasing distributive~     sharing of syringes and other injection paraphernalia and (2) increasing utilization of~     HCV-related healthcare services among HCV-infected injection drug users~   "
241658|NCT00391469|"~     The overall goal of this study is to determine whether initiating hypothermia in cardiac~     arrest patients as soon as possible in the field results in a greater proportion of patients~     who survive to hospital discharge compared to standard prehospital/field care.~   "
241659|NCT00391456|"~     Effects of complementary therapies on heart failure, a leading cause of hospitalization, are~     unknown. Animal-assisted therapy improves physiological and psychosocial variables in healthy~     and hypertensive subjects.~      The purpose of this study was to determine whether a 12-minute hospital visit with a therapy~     dog improves hemodynamics, lowers neurohormone levels, and decreases state anxiety in~     patients hospitalized with heart failure.~   "
241660|NCT00391443|"~     BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group,~     placebo-controlled, event-driven, group sequential, phase III superiority study. The primary~     objective is to demonstrate that bosentan delays disease worsening or death in patients with~     Idiopathic Pulmonary Fibrosis.~   "
241661|NCT00391430|"~     This study will evaluate which parts of the brain are affected by treatment with behavioral~     therapy versus medication therapy in people with post-traumatic stress disorder.~   "
241662|NCT00391417|"~     The purpose of this study is to determine the efficacy and safety of a topical estradiol gel~     for the treatment of hot flushes in postmenopausal women.~   "
241712|NCT00390767|"~     The purpose of this study is to evaluate the safety and activity of increasing doses of~     MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential~     treatment for patients with peripheral arterial disease.~   "
241713|NCT00390754|"~     The objective of this study is to determine whether women in a Medicaid population at risk~     for unintended pregnancy will keep a home pregnancy test on hand and (if necessary) use it~     appropriately.~   "
241663|NCT00391404|"~     Survivors of childhood cancers face a variety of long-term problems. The investigators'~     recent study found that osteoporosis and osteopenia were common among these patients. The~     factors leading to, as well as the best treatment option for, this morbidity are unclear.~     Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However,~     the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer~     survivors have not been tested. The investigators hypothesize that alendronate, an orally~     active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these~     patients.~   "
241664|NCT00391391|"~     Primary Objective:~      To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine~     to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.~      Secondary Objectives:~        -  To describe the immunogenicity of of Investigational Fluzone vaccine to the standard~          Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.~        -  To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone®~          vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.~   "
241665|NCT00391378|"~     Between 1 and 5 percent of patients who have coronary artery bypass surgery suffer a stroke~     following surgery, and 30 percent have new brain lesions that do not produce symptoms and are~     seen only on MRI. In addition, up to 40 percent of patients develop long-term cognitive~     impairment. This study will identify risk factors that predict whether a person undergoing~     heart surgery will develop cerebral infarcts after surgery. It will also identify operative~     and inflammatory factors that may alter the risk, and will evaluate whether the small lesions~     are associated with cognitive decline at 6 months.~      People 18 years of age or older who will undergo coronary artery bypass surgery (CABG), heart~     valve replacement, or combined CABG and valve replacement procedure are eligible for this~     study. Candidates must have no neurological or cognitive impairment before surgery.~      Participants will undergo standard medical and surgical treatment as determined by their~     physicians. In addition, they have the following procedures:~        -  Medical and neurological evaluation before surgery and 24 and 48 hours after surgery.~        -  Brain MRI before surgery, and 48 hours, 30 days and 6 months after surgery.~        -  Blood draws before surgery, immediately after surgery, and 6, 24, 48 and 72 hours after~          surgery to quantify the response of their inflammatory system to surgery.~        -  Neuropsychological examinations 30 days and 6 months after surgery.~        -  In addition, patients who agree to enroll in a substudy that will explore whether~          differences in the genes coding for inflammatory molecules lead to a change in the risk~          of iscjhemia after heart surgery, will have extra blood drawn for genetic analysis.~   "
241666|NCT00391365|"~     The purpose of this study is to determine any functional outcome differences in patients who~     have undergone surgical treatment for ankle osteoarthritis using surveys, step counts, and~     laboratory gait analysis.~      This study is closed to recruitment; follow-up procedures are completed; the study remains~     open for data analysis. Enrollment was completed by August 2012.~      As of July 2016 the study is currently analyzing data, and preparing a journal article for~     publication.~      In April 2017 the study was approved to begin long term follow-up with study participants.~     Study personnel contact participants via telephone and/or U.S. Mail to tell them about long~     term follow-up, and to ask whether they are willing to continue study participation. Long~     term follow-up will be for up to 12 years after the participant's ankle surgery.~   "
241667|NCT00391352|"~     Impaired short term memory, attention and concentration lapses, and slower processing of~     information occur in up to 40-65% of patients with Multiple Sclerosis (MS). The quality of~     life of individuals with MS is impacted to the degree with which they experience these~     symptoms.~      There are several medications approved by the United States Food and Drug Administration~     (FDA) to treat MS symptoms and to modify (slow) disease course. Traditional approaches to~     determining the effectiveness of medications used in treating MS rely on reports of the~     number of relapses an individual experiences, as well as standard clinical tests, such as the~     Kurtzke Expanded Disability Status Scale (EDSS).~      This research study will look at whether the functional magnetic resonance imaging (fMRI)~     scan can be used as a tool for measuring changes in the brain associated with treatment in MS~     patients. Unlike a typical MRI which provides structural information about the brain, the~     fMRI provides information about brain activity during performance of cognitive or motor~     tasks.~   "
241668|NCT00391339|"~     In a prospective, randomised study the efficacy and tolerability of bryophyllum p. (p.o) vs.~     nifedipine (p.o) will be proofed in a defined group of pregnant women with threatened preterm~     labour.~   "
241669|NCT00391326|"~     The purpose of this study is to describe the efficacy and safety of prehospital~     administration of bivalirudin, as a substitute for heparin, in patients with acute myocardial~     infarction redirected for primary angioplasty bypassing local hospitals, immediately after~     the diagnosis is confirmed via tele-transmission of a 12-lead electrocardiogram.~   "
241670|NCT00391313|"~     A severe outbreak of Chikungunya fever has been reported at La Réunion Island (France) in~     2005-2006. Chikungunya is a viral disease. Chikungunya virus is an alphavirus transmitted to~     humans by the bite of infected mosquitoes, usually of the genus Aedes (Aedes albopictus in La~     Réunion).~      To date, more than 266,000 cases were estimated to have occurred in the island (760,000~     inhabitants). Most of cases are expressed as a mild disease, with intense fever and~     arthralgias, with rare but serious complications (encephalitis, liver, cardiac or renal~     failures.) having required a hospitalization in an intensive care unit. 273 of such serious~     cases (immediately life threatening condition) have been reported among the cases, in~     patients aged over 10 days (59% were 65+ age old). Chikungunya was proven in 246 serious~     cases; 101 patients had comorbidities, and 27% of confirmed cases eventually died. In~     addition 44 cases of mother-to-child infections were reported and 40 were confirmed (one~     died).~      To date, in 248 death certificates, chikungunya was reported as the direct or indirect cause~     of death, with a median age of 79, range 0-102, and a sex-ratio (M/F) of 0.95. InVS, in~     collaboration with Inserm (French NIH) also reported (by June 6, 2006) a significant excess~     of mortality (from all causes) during the major outbreak which occurred from December, 2005~     (+10%) to April, 2006 (10.1%), with a peak of excess mortality reached in February (+34.4%),~     concommitant to the peak of incidence.~      Today, there is no antiviral treatment against Chikungunya. We showed from ex-vivo studies~     (in a sensitive model of cells culture to the viral infection) that chloroquine provides a~     significant inhibition on the replication of the Chikungunya virus. This efficacy seemed also~     to be reached at a plasmatic concentration of similar order of magnitude as recommended for~     treating malaria with this drug.~      This trial aims to assess efficacy and safety of chloroquine as as therapeutic treatment of~     chikungunya disease.~   "
241671|NCT00391300|"~     RATIONALE: New diagnostic procedures, such as bioelectric field imaging, may help find and~     diagnose melanoma and other skin cancers. It may also be a less invasive way to check for~     skin cancer.~      PURPOSE: This phase I trial is studying bioelectric field imaging in diagnosing melanoma and~     other skin cancers in patients with skin lesions.~   "
241672|NCT00391287|"~     The purpose of this study is to estimate the incidence rate of pure red cell aplasia (PRCA;~     aplastic anemia) mediated by erythropoietin (EPO) antibodies in patients who are receiving~     subcutaneous (s.c.) epoetin alfa (polysorbate 80 formulation) for the treatment of anemia~     associated with chronic renal failure (CRF), and to compare this incidence rate to the~     incidence rate with s.c. exposure to other currently marketed recombinant erythropoietin~     products (epoetin alfa, epoetin beta, darbepoetin alfa), with adjustment of duration for~     which the drug is given to the patient. The study will also examine the impact of the pattern~     of using mixed s.c. exposure to multiple erythropoietin products occurring in this patients,~     and the impact of the time from which the treatment is started to the onset of PRCA.~   "
241673|NCT00391274|"~     The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel~     administered on a 3-weekly schedule in the treatment of patients with locally advanced or~     metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.~   "
241674|NCT00391261|"~     The aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin~     treatment in children and adolescents suffering from weight gain secondary to use of atypical~     antipsychotic medications. In this 12 week, open-label study we will investigate metformin's~     effects on weight control and/or weight loss. We hypothesize that metformin would prevent~     further weight gain or lead to weight loss, resulting in amelioration of one of the most~     significant side effects of atypical antipsychotic use.~   "
241675|NCT00391248|"~     To improve the clinical outcomes of patients with non-small cell lung cancer treated with~     radiation therapy.~   "
241676|NCT00391235|"~     Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will~     receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a~     clinical interview, including the KSADS-PL. All subjects must be right-handed.~   "
241677|NCT00391222|"~     The purpose of this randomized, double blind, double dummy, multicenter study was to evaluate~     the efficacy of risperidone long-acting injectable (LAI) monotherapy in comparison with~     placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder.~     Oral olanzapine was used to assess the validity of the study design. The primary objective of~     this study is to evaluate the efficacy of risperidone LAI versus placebo in the prevention of~     a mood episode (recurrence event) in patients with bipolar I disorder after a 12-week (3~     month) stabilization period on risperidone LAI, as measured by the time to recurrence of any~     mood episode. Risperidone LAI has been approved by the FDA in the USA for the treatment of~     patients with schizophrenia and for the prevention of mood recurrences in bipolar I disorder,~     as monotherapy or add-on treatment. It is approved at EMEA and other European and~     non-European health authorities for the treatment of patients with schizophrenia, too.~   "
241678|NCT00391209|"~     This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month~     study with approximately 360 patients will compare the efficacy of two treatment regimens~     (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally~     controlled by one or more oral antihyperglycemic medications. Patients will be assigned~     randomly to receive one of the following treatment groups:~      Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose~     of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of~     Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose~     values for the first month and titrating 1 time per week based on once weekly 4-point blood~     glucose values for the remainder of the study, increasing total daily dose by a maximum of 6~     U per day.~      Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted~     dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose~     values, with sustained monitoring of dose and blood glucose throughout the study, increasing~     total daily dose by a maximum of 8 U per day.~   "
241679|NCT00391196|"~     The purpose of this study is to determine if CP-945,598 is effective in the treatment of~     obesity in type 2 diabetic patients.~   "
241680|NCT00391183|"~     The purpose of the study is to determine whether palliative biliary stenting improves the~     quality of life, of gallblader cancer patients, who present with hilar block and obstructive~     jaundice.~   "
241681|NCT00391170|"~     This study will determine if a dexamethasone mouth rinse can reduce the risk of developing~     oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow~     (stem cell) transplant procedure. cGVHD is a common complication of stem cell~     transplantation, resulting from the donor cells attacking the transplant recipient's tissues.~     In oral cGVHD, the tissues in the mouth are damaged, causing painful mouth sores.~     Dexamethasone is a corticosteroid that is commonly used to treat inflammation. It is the only~     corticosteroid available that can be used as a mouth rinse.~      Patients 12 years of age or older who have received a stem cell transplant may be eligible to~     participate if they are enrolled within 70 to 90 days of their transplant. Candidates are~     screened with a medical history and oral exam.~      Participants are randomly assigned to receive either the dexamethasone rinse or a placebo (a~     solution that looks and tastes like the dexamethasone rinse but has no active medication).~     They undergo the following procedures:~      Treatment with the study solution. Patients rinse their mouth with the dexamethasone solution~     or placebo three times a day for 3 months.~      Clinic visits before starting treatment and at 1, 2 and 3 months after starting the study~     drug for the following procedures:~        -  Oral exam (before starting treatment and at each visit).~        -  Photographs of the mouth (before starting treatment and at 3 months).~        -  Biopsy from inside the cheek (before starting treatment). The inside of the cheek is~          numbed and a small piece of tissue is removed for examination by a pathologist.~        -  Saliva sample collection (before starting treatment).~        -  Blood draw (before starting treatment and at each visit).~        -  Quality-of-life questionnaires (before starting treatment and at 3 months).~        -  Questionnaire to assess level of dry mouth and mouth pain (before starting treatment and~          at each visit).~        -  Review of medications (at each visit).~        -  ACTH stimulation test to evaluate adrenal gland function (at 3 months). Patients are~          given an injection of a drug called ACTH or cosynthropin, which is a version of a~          hormone normally produced by the pituitary gland. Blood samples are drawn before the~          injection and at 30 and 60 minutes after the injection to measure levels of the hormone~          cortisol.~      After treatment ends, participants are contacted by telephone every month for 6 months to~     report any symptoms of cGVHD, and they return to the clinic at 6 months for a final~     evaluation.~   "
241682|NCT00391157|"~     The primary efficacy objective of this study is to study the efficacy in terms of response~     rate to alternating bortezomib/dexamethasone regimen~   "
241683|NCT00391144|"~     The natural history of subfoveal CNV secondary to Pattern Dystrophy is little understood, but~     it seems that visual function may be preserved only in the short-term follow-up, with~     progressive deterioration thereafter.~      Photodynamic therapy with verteporfin is the most studied therapeuthic option for this kindf~     of lesion, but unfortunately, this approach does not appear to guarantee long-term vision~     stabilization, and alternative therapies should be investigated.~   "
241859|NCT00388817|"~     The purpose of this trial is to determine whether minority and low-income patients with high~     blood pressure take their medications better when they are helped by a pharmacist and~     provided with special medication packaging and information aimed at persons with low health~     literacy.~   "
241684|NCT00391131|"~     This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig~     NextGen 16% in people with antibody deficiency currently being treated with IntragamP. Ig~     NextGen 16% is a liquid immunoglobulin (antibody) preparation manufactured using~     predominately chromatographic techniques. Eligible patients will switch from monthly~     intravenous IntragamP therapy to weekly subcutaneous Ig NextGen 16% treatment. Initial~     hospital training will be required for subcutaneous administration and then the patient will~     perform the infusion in their own home, returning once a month for a supervised infusion.~     Patients will be monitored on the study for up to 10 months to assess blood IgG levels and~     rate of serious bacterial infections.~   "
241685|NCT00391118|"~     Patients with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial~     treatment. In many patients the tumor will shrink, or even disappear, after treatment with~     these drugs. But, unfortunately, the tumor will grow again in many patients. This trial will~     try to address the question: Can we delay the time, till the tumor grows again, by adding a~     3rd drug to the standard therapy? To answer this question, patients will, by chance, either~     get the experimental drug enzastaurin or a dummy pill (placebo) during the chemotherapy and~     for up to 3 years after chemotherapy. Patients and physicians will not know, if a patient~     gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment~     will be uncovered, and the number of patients with tumor growth at a specific time point will~     be compared between the two treatments.~   "
241686|NCT00391105|"~     In this randomised controlled study we intended to compared intubation conditions and the~     continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated~     premature neonates (28-34wk) regarding the time to be awake and, the time until extubation~     after interruption of the opioid administration.~   "
241687|NCT00391092|"~     This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel,~     versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or~     metastatic breast cancer who have not received prior chemotherapy for their metastatic~     disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) +~     Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv~     q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until~     disease progression, and the target sample size is 100-500 individuals.~   "
241688|NCT00391079|"~     The purpose of this study is to find out if cannabis-based medicine compared to a dummy~     medicine (placebo that contains no active ingredient) can help the central neuropathic pain~     patients experience as a result of multiple sclerosis. This type of pain central neuropathic~     pain is described as shooting, stabbing, burning or searing like sensation, which is often~     worse at night.~   "
241689|NCT00391066|"~     This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with~     previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either~     lumiliximab in combination with FCR or FCR alone.~   "
241690|NCT00391053|"~     Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus,~     improvement of the immune response to influenza vaccination in this age group, which is at~     higher risk for influenza-related morbidity and mortality, represents an important unmet~     need.~      Primary Objectives:~      Immunogenicity:~        -  To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing~          process through evaluation of the immune responses elicited by three different lots.~        -  To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone®~          vaccine.~      Secondary Objectives:~      Immunogenicity:~        -  To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone®~          vaccine.~      Safety:~        -  To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited~          adverse and serious adverse events post-vaccination.~        -  To describe clinical information on some additional defined criteria during the six~          months following vaccination.~   "
241691|NCT00391040|"~     It was the aim of the study to develop and evaluate the effectiveness of a new structured~     teaching and training programme for elderly patients with diabetes mellitus (SGS) and insulin~     therapy.~   "
241692|NCT00391027|"~     To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes~     mellitus.~   "
241693|NCT00391014|"~     The trial is planned as a multicentric, national, phase II, open-label trial to evaluate~     safety and tolerance of nebulized Liposomal Amphotericin B (Ambisome) for LMA patients during~     the induction therapy ,intensification, plus Allogeneic Haematopoietic Progenitor Cell~     transplant in due course, as well for patients diagnosed of several malignant haematologic~     diseases and treated with Allogeneic Haematopoietic Progenitor Cell Transplant~   "
241694|NCT00391001|"~     Recently, McLean hospital conducted a 4 month taurine study which showed a reduction in mania~     ratings. As a follow-up to the preliminary taurine study, and complementary to the currently~     ongoing double-blind, placebo-controlled trial for taurine in adults with bipolar disorder,~     this study will target adolescent bipolar subjects (type I) with symptoms of mania or mixed~     mania. To our knowledge, this would be the first study to evaluate the effects of the novel~     compound taurine in adolescent subjects with bipolar disorder.~      We hypothesize there will be a positive response in some adolescents from taurine treatment,~     and this positive response will be greater than that expected by chance. This study may~     demonstrate that taurine is a well-tolerated and effective adjunct treatment for mania in~     bipolar disorder.~   "
241695|NCT00390988|"~     The purpose of this study is to compare capillary blood count parameters with the~     corresponding venous samples to verify the hypothesis that capillary and venous blood count~     parameters are equivalent.~   "
241696|NCT00390975|"~     This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis~     treated with tegaserod over 2 weeks.~   "
241728|NCT00390559|"~     Treatment studies have demonstrated that current smoking cessation techniques are less~     effective for women. The purpose of this study is to determine the role that gender plays in~     the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is~     to determine whether men and women differ in their response to smoking-related stimuli (e.g.,~     taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve~     cessation interventions for all smokers, particularly women.~   "
254832|NCT00215384|"~     The purpose of this study is to determine which dose of the investigational drug is the most~     safe and effective compared to the control drug.~   "
241697|NCT00390962|"~     Sodium imbalance is common and an adverse prognostic factor in hospitalized patients.~     However, identifying the causes of sodium imbalance is challenging in clinical practice.~     Levels of antidiuretic hormone (ADH) are elevated in patients with stroke correlating with~     disease severity and stress level; however, its measurement is cumbersome. ADH is derived~     from a larger precursor peptide along with Copeptin, which is a more stable peptide directly~     mirroring the production of ADH. Copeptin can be assayed readily in plasma. Early prognostic~     factors to predict in-hospital mortality and medium/long-term outcome in critically ill~     neurological patients, are helpful to guide and tailor early decisions on treatment,~     discharge from the intensive care unit and application of interventions to prevent~     deterioration of neurological functions.~      We hypothesize that copeptin will improve the diagnostic accuracy to diagnose sodium~     imbalances as compared to routinely used markers Furthermore, we hypothesize that Copeptin~     will be a reliable prognostic tool, dependent or independent of sodium imbalance, to predict~     short-term (i.e. in-hospital) and medium-term (i.e. 3 months) clinical outcome in stroke~     patients.~   "
241698|NCT00390949|"~     The purpose of this study is to determine whether community-based peer education and condom~     distribution combined with improved treatment of sexually transmitted infections are~     effective in reducing the spread of HIV infection in a sub-Saharan African population~   "
241699|NCT00390936|"~     The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the~     maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.~   "
241700|NCT00390923|"~     This study will test a new medication strategy designed to help smokers quit. It will combine~     selegiline, a drug currently approved and available for the treatment of Parkinson's disease,~     with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study.~     Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive~     selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine~     Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief~     health check, collection of breath and urine samples (necessary to drug levels and nicotine~     levels), and receive brief individual counseling designed to help them stop smoking. The~     medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months~     after trial completion. At that point, health and behavioral measures will be re-assessed.~   "
241701|NCT00390910|"~     This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline~     (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with~     diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio~     virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose~     primary immunization course during the first 6 months of life.~      This protocol posting deals with objectives & outcome measures of the primary study. The~     objectives & outcome measures of the Booster study are presented in a separate protocol~     posting (NCT number = 00609492)~   "
241702|NCT00390897|"~     To compare the complete cytogenetic response rate in patients with newly-diagnosed~     chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with~     interferon at low doses~   "
241703|NCT00390884|"~     To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone~     vaccine (2006-2007 formulation).~   "
241704|NCT00390871|"~     Dexmedetomidine (Precedex, Hospira) is a super selective alpha2-agonist - 8-10x more avid~     binding to alpha2 receptors than clonidine - and may have particularly favorable~     characteristics as a continuous i.v. infusion sedative for critically ill neuroscience~     patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an~     ideal agent where frequent neurological examinations are important (12). Unclear, however, is~     whether Precedex is superior to current common i.v. sedation protocols, and if there are any~     undue concerns of this agent on cerebral physiology and cortical stimulation.~   "
241705|NCT00390858|"~     In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox~     in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients~     who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in~     this extension trial and receive chelation therapy with deferasirox for up to 4 years.~   "
241706|NCT00390845|"~     This will be a double-blind, placebo controlled cross-over study. After enrolment and initial~     assessments, subjects will receive oral SB681323 or matching placebo for 14 days. SB681323~     will be administered twice daily at a total daily dose of 7.5mg. Sufficient numbers of~     patients will be recruited to obtain 40 evaluable patients~   "
241707|NCT00390832|"~     The purpose of this study is to determine whether erythropoietin is superior to placebo with~     respect to left ventricular ejection fraction in patients with ST-elevation myocardial~     infarction undergoing percutaneous coronary intervention.~   "
241708|NCT00390819|"~     Pneumonia in general and CAP in particular is considered as one of the most common bacterial~     infections, associated with high rates of morbidity and mortality and is highly significant~     economically since all respiratory infections, and pneumonia especially, cause about 80% of~     antimicrobials use in the community. The high frequency of respiratory infections and the~     excessive use of antimicrobials are major contributors to the development of pathogens~     resistant to antimicrobials. In addition, in CAP almost all patients are treated empirically,~     without identification of causing pathogen.~      Aim of study: To identify common pathogens causing CAP in hospitalized patients in north~     Israel.~   "
241709|NCT00390806|"~     The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The~     current standard treatment for this disease is radiation therapy to the brain. The goal of~     the current study is to test whether the combination of orally administered HYCAMTIN capsules~     and whole brain radiation therapy will prolong the survival time of patients with this~     potentially serious condition.~   "
241710|NCT00390793|"~     The goal of this clinical research study is to find out if intensive chemotherapy combined~     with dasatinib, followed by maintenance therapy, can help to control ALL with the Ph~     chromosome and/or BCR-ABL. The safety of this treatment will also be studied.~   "
241711|NCT00390780|"~     The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg~     (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days~     of treatment (at the test of cure visit, at Day 17-19).~   "
241714|NCT00390741|"~     The major goals of this study are:~        1. To conduct an intervention development study to evaluate the feasibility of implementing~          an exercise intervention for reduction losses in bone mineral density, muscle mass, and~          strength, and clinically relevant aspects of functioning following a hip fracture, and~          to obtain preliminary tests of the effective ness of these interventions.~        2. To evaluate the effect of home-based exercise intervention on bone metabolism.~        3. To evaluate the effects of hip fracture on bone metabolism.~        4. To evaluate the effects of exercise and hip fracture on hormonal regulators.~        5. To evaluate the association between markers of bone metabolism hormone regulators, and~          BMD.~        6. To separate out the effects of hip fracture on bone turnover from those of aging in~          persons with low bone mineral density.~   "
241715|NCT00390728|"~     Primary objective:~      AT.LANTUS main study*~        -  To determine the optimal treatment algorithm for insulin glargine based on the incidence~          of severe hypoglycaemia.(*Target Number of patients for the main study:2346)~      HALT Sub-study**~        -  To test the hypothesis that titration regimens involving insulin glargine are associated~          with changes in the rate of symptomatic hypoglycaemic episodes together with changes in~          Fear of Hypoglycaemia as measured by the HFS-98 Questionnaire in Type I~          diabetes.(**Target Number of patients for the Sub-study: 250)~      Secondary objectives:~      AT.LANTUS main study~      To determine:~        -  the incidence of symptomatic, asymptomatic and nocturnal hypoglycaemia with each~          treatment regimen~        -  the difference in glycemic control as measured by HbA1c and fasting blood glucose with~          each treatment regimen~        -  the difference in glycemic control as measured by HbA1c and fasting blood glucose~          between baseline and end of treatment~        -  the safety on the use of insulin glargine in each treatment algorithm~        -  the change in subject weight with each treatment regimen~        -  the change in insulin doses with each treatment regimen~        -  the change in Diabetes Treatment Satisfaction (Diabetes Treatment Satisfaction~          Questionnaire, sub-study only) with each treatment regimen~      HALT Sub-study (baseline to study end)~        -  To estimate the relationship between change in HbA1c and incidence of hypoglycaemia~        -  To examine the effect of insulin glargine on Quality of Life (EQ-5D) in relation to~          incidence of hypoglycaemia~        -  To examine the effect of insulin glargine on the Hospital Anxiety and Depression Scale~          (HADS) in relation to the incidence of hypoglycaemia~        -  To examine the use of the Prescription Plan versus standard management (no Prescription~          Plan)~   "
241716|NCT00390715|"~     study of the value of the cytogenetics and the monitoring of the residual minimum disease in~     the standard treatment of acute myeloblastic leukemia.~   "
241717|NCT00390702|"~     The Ventricular septal defect (VSD) is the most common of all congenital cardiac~     malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System~     was designed. as a percutaneous, transcatheter device for occlusion of (peri)membranous and~     muscular ventricular septum defects (VSD) with a spiral coil. In this clinical investigation~     feasibility, safety and performance of the new cardiac occluder will be evaluated in~     accordance with European and US regulations. The study data will be compared to performance~     criteria for VSD, which are deduced analogue to the published specific Objective Performance~     Criteria (OPCs) for PDAs. The first part of the study has been performed in three clinical~     centres in Germany. For the second part in April 2009 four additional clinical centres in~     Germany, Israel, Italy and Spain were included.~   "
241718|NCT00390689|"~     The objective of double blind phase in this trial is to compare the efficacy and safety at~     the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label~     phase in this trial is to investigate the long term safety and efficacy of pramipexole in~     RLS.~   "
241719|NCT00390676|"~     N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer~     progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study~     will test the safety and effects of the combination ADH-1 and carboplatin or ADH-1 and~     docetaxel or ADH-1 and capecitabine in subjects with specific incurable, solid tumors with a~     protein biomarker called N-cadherin.~   "
241720|NCT00390663|"~     To determine whether the selective application of a combined treatment regimen of silver~     nitrate cautery and 4 weeks of Naseptin cream is superior to naseptin treatment alone in the~     management of recurrent paediatric epistaxis.~   "
241721|NCT00390650|"~     The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to~     placebo in patients with generalized anxiety disorder. The secondary objectives are to~     evaluate the efficacy of saredutant on disability and quality of life in patients with~     generalized anxiety disorder, and to evaluate blood levels of saredutant.~   "
241722|NCT00390637|"~     Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat~     diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on~     bodyweight in overweight and obese subjects after an initial weight loss.~   "
241723|NCT00390624|"~     The purpose of the study is to combine Urodilatin (ANP analogue), which will increase~     glomerular filtration rate (GFR), and mannitol, which will increase the rate of urinary flow~     and solute excretion. We intend to treat twenty consecutive allogeneic bone marrow transplant~     patients in a phase II study comparing results with historical controls.~      We hypothesize that the incidence of renal dysfunction, ARF and thus mortality in allogeneic~     bone marrow transplantation can be significantly reduced by the use of protective agents~     Urodilatin and mannitol. We feel that this combination is best administered prior to and~     during the first two weeks of treatment when patients encounter immunosuppressive agents and~     the onset of early transplantation complications.~   "
241724|NCT00390611|"~     This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone~     vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer~     following cytoreductive surgery. Patients with residual large volume disease and/or bowel~     involvement will be excluded, to minimize the risk of bowel perforation.~   "
241725|NCT00390598|"~     The trial compares Laxabon® 4L versus Pursennid® Ex-Lax 36mg and 2L Laxabon® for large bowel~     cleansing prior to colonoscopy allocating patients planned for colonoscopy to one of the two~     cleansing regimens.~   "
241726|NCT00390585|"~     The purpose of this study is to demonstrate that Iodixanol 320 is associated with a lower~     incidence of contrast-induced nephropathy (CIN) when compared with hyperosmolar contrast~     medium Iomeprol 350 in patients with impaired renal function undergoing percutaneous coronary~     interventions (PCI).~   "
241727|NCT00390572|"~     Sleep disorders are prevalent health problems that reduce quality of life, increase risks for~     medical disease, and enhance healthcare costs/utilization. Only a small proportion of these~     cases are diagnosed in primary care. Pilot data from this VA suggest that sleep disorders are~     not adequately managed in a primary care setting: 33% of veterans with an insomnia complaint~     had an undiagnosed primary sleep disorder (e.g., sleep apnea), and 50% of these patients were~     prescribed pharmacologic treatment for insomnia by their primary care providers.~   "
241743|NCT00390364|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with~     advanced or metastatic colorectal cancer that did not respond to previous therapy.~   "
241729|NCT00390546|"~     This is a randomized, double-blind, multi-centered study to compare 6 months of medical~     treatment with digoxin or propranolol in infants with SVT Background: SVT is the most common~     sustained arrhythmia of infancy. Neither digoxin nor propranolol has been evaluated for~     pediatric use in a controlled trial in the context of SVT, yet both medications are used~     frequently.~      Specific aims of the study:~      To determine whether propranolol and digoxin differ in the:~        1. Incidence of recurrent SVT in infants after 6 months of treatment with propranolol or~          digoxin~        2. Time to first recurrence of SVT in infants treated with propranolol or digoxin.~        3. Incidence of adverse outcomes in infants treated with propranolol or digoxin.~   "
241730|NCT00390533|"~     The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once~     daily) of saredutant compared to placebo in patients with generalized anxiety disorder. The~     secondary objectives are to evaluate the efficacy of saredutant on disability and quality of~     life in patients with generalized anxiety disorder, and to evaluate blood levels of~     saredutant.~   "
241731|NCT00390520|"~     This mechanistic study is designed to investigate the effect of vildagliptin on the~     sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2~     diabetes (T2DM).~   "
241732|NCT00390507|"~     The purpose of this study is to examine the relationship between post-tetanic count (PTC) and~     time to first response to Train of four (TOF) stimulation during deep neuromuscular blockade~     induced by rocuronium.~   "
241733|NCT00390494|"~     The purpose of this study is to determine the change in symptoms and health-related quality~     of life in patients undergoing treatment for fibroids. Results from the questionnaire will be~     compared with results obtained from patients who do not have fibroids in order to determine a~     score range that differentiates these two groups.~   "
241734|NCT00390481|"~     To determine the relationship between cognitive functioning and blood flow in the brain among~     patients randomized to either extracranial-intracranial (EC-IC) bypass or medical therapy~     alone in the Carotid Occlusion Surgery Study (COSS).~   "
241735|NCT00390468|"~     RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with~     progressive prostate cancer and bone metastases.~   "
241736|NCT00390455|"~     This randomized phase III trial studies fulvestrant and lapatinib to see how well they work~     compared to fulvestrant and a placebo in treating postmenopausal women with stage III or~     stage IV breast cancer that is hormone receptor-positive. Estrogen can cause the growth of~     breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering~     the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells~     by blocking some of the enzymes needed for cell growth. It is not yet known whether~     fulvestrant is more effective with or without lapatinib in treating breast cancer.~   "
241737|NCT00390442|"~     In cardiogenic pulmonary edema, Continuous Positive Airway Pressure (CPAP) added to medical~     treatment improves outcome. The present study was designed to assess the benefit of CPAP as a~     first line treatment of cardiogenic pulmonary edema in the out-of-hospital environment.~   "
241738|NCT00390429|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving docetaxel together with erlotinib may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when~     given together with docetaxel in treating patients with solid tumors and to see how well they~     work in treating patients with advanced non-small cell lung cancer. (Phase I portion of the~     study treating patients with any solid tumor was completed as of 12/01/2004)~   "
241739|NCT00390416|"~     This study is being done to find out what effects a drug named/called bevacizumab has on~     patients and patients' tumors when given together with standard chemotherapy drugs. Making~     new blood vessels seems to be important for many tumors to grow. Bevacizumab is a new type of~     treatment for cancer that blocks the growth of new tumor blood vessels. In this study, the~     researchers will combine bevacizumab with chemotherapy drugs that are standard for the~     patient's disease and include cisplatin, docetaxel, fluorouracil, and leucovorin. The way the~     original combination of cisplatin, docetaxel, and fluorouracil was given caused many side~     effects including gastrointestinal symptoms, weakness, and a drop in the blood count of~     infection fighting cells. For this study, the researchers have modified this combination to~     give lower doses of the medicines more often, to reduce side effects from the chemotherapy.~     Patients will receive bevacizumab with this modified combination of docetaxel, cisplatin, and~     fluorouracil. This study is called a phase II study. In this study, everyone will have~     similar tumors and receive the same treatment.~   "
241740|NCT00390403|"~     RATIONALE: Drugs used in chemotherapy, such as gossypol and temozolomide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Gossypol may help~     temozolomide work better by making tumor cells more sensitive to the drug. Gossypol may also~     make tumor cells more sensitive to radiation therapy. Giving gossypol and temozolomide~     together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of gossypol when given~     together with temozolomide with or without radiation therapy in treating patients with newly~     diagnosed glioblastoma multiforme.~   "
241741|NCT00390390|"~     Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic~     stomach contents move into the esophagus from the stomach. This study will investigate the~     safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.~   "
241742|NCT00390377|"~     This study aims to perform x-ray diffraction analysis of blinded hair samples from women with~     a documented health status, to validate the previous findings of James et al who described~     that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects~     from those of diseased subjects, specifically those suffering from breast cancer.~      The primary hypothesis is that x-ray diffraction of hair can be used to distinguish hair from~     patients with confirmed breast cancer from subjects without detectable breast cancer.~   "
254833|NCT00215371|"~     The purpose of this study is to determine which dose of the investigational drug is safest~     and most effective compared to the control group.~   "
241744|NCT00390351|"~     We will do systematic and functional assessment of non-melanoma skin cancer including~     precancerous lesions by OCT imaging and other diagnostic methods. The systematic assessment~     will be comparison of clinical diagnosis, histopathology, OCT images, spectrophotometry and~     high frequency ultrasound of non-melanoma skin cancer Functional exploration of non-melanoma~     skin cancer is done with Doppler-OCT and polarization-sensitive-OCT.~   "
241745|NCT00390338|"~     RATIONALE: Vaccines made from a person's dendritic cells mixed with tumor peptides and~     proteins may help the body build an effective immune response to kill tumor cells. Infusing~     the vaccine directly into the lymphatic system may cause a stronger immune response and kill~     more tumor cells.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of two~     dendritic cell vaccines in treating patients with stage III or stage IV melanoma.~   "
241746|NCT00390325|"~     This phase II trial studies how well sorafenib tosylate works in treating patients with~     medullary thyroid cancer that has spread to other parts of the body (metastatic), spread to~     the tissue surrounding the thyroid (locally advanced), or has returned after a period of~     improvement (recurrent). Sorafenib tosylate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
241747|NCT00390312|"~     This study involves approximately 200 patients designed to evaluate the efficacy and safety~     of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate~     release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain~     following third molar extraction.~   "
241748|NCT00390299|"~     This phase I trial studies the side effects and best dose of carcinoembryonic~     antigen-expressing measles virus (MV-CEA) in treating patients with glioblastoma multiforme~     that has come back. A virus, called MV-CEA, which has been changed in a certain way, may be~     able to kill tumor cells without damaging normal cells.~   "
241749|NCT00390286|"~     This is a 6 year, Phase I, Clinical Research Protocol to study the feasibility of using a~     telemedicine system for performing research in a remote hospital system.~   "
241750|NCT00390273|"~     The main objective of this study is to evaluate the influence of metformin on lactate~     metabolism.~      The main outcome is the lactate production following an exogenous lactate overload in healthy~     male subjects without metformin and one week later with metformin.~   "
241751|NCT00390260|"~     Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with~     acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.~   "
241752|NCT00390247|"~     Hypothesis In peritoneal dialysis (PD) patients, malnutrition, inflammation and~     atherosclerotic cardiovascular disease commonly coexist. The triad has been coined the MIA~     syndrome. Proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-alpha), plays~     a central role in the pathogenesis of the MIA syndrome. Thalidomide selectively inhibits the~     production of TNF-alpha and represents a valuable anti-cytokine therapy.~      Specific Aim To study the effect of thalidomide in attenuating or reversing malnutrition and~     systemic inflammation in PD patients.~      Research Plan~      Design: Double-blinded randomised prospective placebo control trial. Setting: Renal unit of a~     university teaching hospital. Subjects: Sixty prevalent PD patients with evidence of~     malnutrition. Interventions: Patients will be randomised to receive either oral thalidomide~     100 mg nocte or placebo.~      Main outcome measures: Patients will be followed for 1 year. Nutritional parameters including~     serum albumin, subjective global assessment, malnutrition-inflammation score, normalised~     protein nitrogen appearance, fat-free edema-free body mass and anthropometry measurements~     will be monitored. Systemic inflammatory markers such as serum C-reactive protein and IL-6~     will be assayed. Hospitalisation, cardiovascular events, and overall patient survival will~     also be compared during study period.~      Expected Outcome~      Nutritional parameters and markers of systemic inflammation are expected to improve with~     thalidomide therapy. The magnitude of improvement in nutrition, as well as patient morbidity,~     will be compared with placebo.~      In Hong Kong, 80% of end-stage renal failure patients are treated with PD. Malnutrition,~     cardiovascular disease and systemic inflammatory response are all common in our clinical~     practice. They are major causes of patient morbidity and mortality. As a readily available~     anti-cytokine therapy, thalidomide may represent a valuable treatment of the MIA syndrome.~     The proposed study will provide important insight on the clinical benefit of thalidomide~     treatment in malnourished PD patients, which accounts for about one-third of our dialysis~     population.~   "
241753|NCT00390234|"~     This phase II trial is studying how well ziv-aflibercept works in treating patients with~     locally advanced, unresectable or metastatic gynecologic soft tissue sarcoma. Ziv-aflibercept~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and~     by blocking blood flow to the tumor.~   "
241754|NCT00390221|"~     The primary objective of this study is to determine whether DAC HYP, when compared to~     placebo, is effective in reducing the rate of relapses between baseline and Week 52. The~     secondary objectives are to determine whether DAC HYP is effective in reducing the number of~     new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2~     hyperintense lesions, reducing the proportion of participants with relapses, and improving~     quality of life.~   "
241755|NCT00390208|"~     The purpose of this study is to compare triple therapy using Photodynamic therapy,~     intravitreal Dexamethasone and intravitreal Ranibizumab injections versus monotherapy with~     intravitreal Ranibizumab alone for the treatment of Age-Related Macular Degeneration.~   "
241756|NCT00390195|"~     The mTOR has been examined in hepatocellular carcinomas as well. This pathway is up-regulated~     in a proportion of hepatocellular carcinoma (HCC) and that rapamycin inhibits cell~     proliferation and blocks S6K phosphorylation. Inhibition of mTOR had been shown to suppress~     substantially the liver tumor growth. Nevertheless, inhibition of mTOR was demonstrated to~     have a clinical response in some cancer types. These reports imply that inhibition of mTOR~     could be a promising therapeutic strategy in the treatment of HCC. Therefore, we hypothesize~     that RAD001, a rapamycin analog, can inhibit the mTOR, and subsequently suppress the liver~     tumor in the treatment of HCC patients.~      This study is aimed to investigate the safety, efficacy, pharmacokinetics, pharmacogenetics~     and feasibility of RAD001 in advanced HCC patients. This study will be a randomized phase I~     study with dose escalation and subsequently a phase II study of intent to treat, as well as~     pharmacokinetic, pharmacogenetic and surrogate marker study of RAD001.~   "
241757|NCT00390182|"~     The purposes of this study are:~        1. To assess the maximum tolerated dose of low-dose UART(Upper Abdominal Radiation Therapy~          ) or WART(Whole Abdominal Radiation Therapy) given in combination with standard fixed~          dose-rate Gemcitabine in patients with advanced gastrointestinal (GI) or ovarian tumors~          (Phase I).~        2. To assess response rate and survival in advanced upper GI tumors following completion of~          therapy (Phase II).~   "
241813|NCT00389415|"~     This 52-week multicenter open-labeled extension study is designed to assess the long-term~     safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is~     open to patients who have completed core study CLAF237A1303.~   "
241758|NCT00390169|"~     This study will compare three standard treatment programs commonly offered to patients with~     breast cancer. The three programs being compared are 1) Mindfulness Meditation-Based Stress~     Reduction (MBSR), 2)Supportive- Expressive Group Therapy (SET), and 3) A one day~     stress-management seminar. The purpose of this study is to determine if these three~     treatments have different effects on psychological well-being, the immune system, and the~     amount of stress hormones in the bloodstream.~   "
241759|NCT00390156|"~     RATIONALE: Imatinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Bevacizumab and~     cyclophosphamide may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Imatinib and bevacizumab may help cyclophosphamide work better by making tumor cells more~     sensitive to the drug. Giving cyclophosphamide once a day together with imatinib and~     bevacizumab may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib when given~     together with bevacizumab and cyclophosphamide in treating patients with refractory~     metastatic solid tumors.~   "
241760|NCT00390143|"~     This study will investigate the long-term protection offered by GSK Biologicals'~     meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at~     15 to 19 years of age. This extension phase starts 18 months after vaccination and part of~     the subjects who were vaccinated in the primary study will be enrolled in this extension~     phase. No new subjects will be enrolled. This protocol posting deals with objectives &~     outcome measures of the extension phase 18, 30 and 42 months after vaccination. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA~     Amendment Act, September 2007.~   "
241761|NCT00390130|"~     The objective of this study is to determine whether there should be a predetermined sequence~     recommended for administering these two vaccines, with the less painful vaccine being given~     first.~   "
241762|NCT00390117|"~     RATIONALE: AT7519M may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of AT7519M in treating~     patients with advanced or metastatic solid tumors or refractory non-Hodgkin's lymphoma.~   "
241763|NCT00390104|"~     The purpose of this study is to identify genes and proteins responsible for nerve and muscle~     disorders by studying genetic material from individuals with neuromuscular disease, as well~     as their family members. We are interested in recruiting many types of neuromuscular disease~     including; Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), and~     limb-girdle muscle dystrophy (LGMD). There are still many patients diagnosed with muscular~     dystrophy but have no causative gene implicated in their disease. We feel that these patients~     may have new genetic changes in genes coding for important muscle proteins that we have yet~     to identify. Using molecular genetics to unravel the biochemical basis of these neuromuscular~     disorders should lead to more accurate diagnosis of these disorders and should lead to~     potential therapies.~   "
241764|NCT00390091|"~     The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP~     394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.~   "
241765|NCT00390078|"~     At the end of 2004 there were more than 40 million people infected Worldwide with HIV, with~     an estimated 16,000 new infections every day (UNAIDS, 2004). The HIV epidemic threatens whole~     societies particularly in Africa and Asia and rates of infections in the Western Countries~     have also increased over the last few years. However, despite more than 15 years of research,~     an effective vaccine against HIV and acquired immunodeficiency syndrome (AIDS) has still not~     been developed.~      There is considerable evidence that cellular immune responses can effectively control HIV-1~     replication during acute and chronic infections thereby possibly protecting individuals from~     infection and preventing the spread of HIV. To be truly effective in the general population,~     a vaccine must induce responses specific to immunologically conserved regions. The~     epitope-based vaccine MVA-mBN32 represent a very logical approach to this problem because its~     potential to elicit a polyfunctional immune response and to focus these responses to~     conserved epitopes.~      In this study the safety, tolerability and immunogenicity of a recombinant MVA-BN® expressing~     CTL and HTL epitopes of HIV-1 (MVA-mBN32) vs. the vector control MVA-BN® in 30 HIV-infected~     subjects will be examined. This will include a full analysis of CD4+ T helper cells and CD8+~     CTL responses to these epitopes, to establish the potential of such a homologous prime-boost~     vaccine approach to induce a broad cell-mediated response to different HIV antigens.~   "
241766|NCT00390065|"~     Utilization of nitric oxide (NO) therapy has been related to a trend towards short term~     improvement in very premature infants. A two year follow-up of children treated soon after~     birth with NO in the neonatal period, suggests that a significant improvement in~     neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in~     respiratory and neurodevelopmental outcome, of children born very prematurely, some of them~     having been treated with nitric oxide in the neonatal period.~   "
241767|NCT00390052|"~     This phase I trial is studying the side effects and best dose of 3-AP in treating patients~     with advanced or metastatic solid tumors. 3-AP may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
241768|NCT00390039|"~     Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and~     placebo-controlled study in patients with moderate to severe post-surgical pain from elective~     orthopedic surgery with safety observed for a total of 30 hours post first dose.~   "
241769|NCT00390026|"~     The object of the study is to compare the treatment effect of bevacizumab (Avastin), an~     antibody targeting vascular endothelial growth factor, with verteporfin photodynamic therapy~     (PDT) for patients with neovascular age-related macular degeneration, the leading cause of~     vision severe loss in the Western world.~   "
241770|NCT00390013|"~     The purpose of this research study is to evaluate if the medication gabapentin lessens the~     vulvar pain some women experience.~   "
254834|NCT00215358|"~     The purpose of this study is to determine which dose of the investigational drug is safest~     and most effective compared to the control drug.~   "
241771|NCT00390000|"~     RATIONALE: Vatalanib and pemetrexed disodium may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Vatalanib may also stop the growth of tumor cells~     by blocking blood flow to the tumor. Giving vatalanib together with pemetrexed disodium may~     kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib when~     given together with pemetrexed disodium in treating patients with advanced solid tumors.~   "
241772|NCT00389987|"~     This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with~     respect to the clinical response in baseline microbiologically evaluable patients; and to~     evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.~   "
241773|NCT00389974|"~     This phase II trial studies the side effects and how well sunitinib malate works in treating~     patients with cervical cancer which cannot be cured by standard therapy. Sunitinib malate may~     stop the growth of cervical cancer by blocking some of the enzymes needed for cell growth and~     by blocking blood flow to the tumor.~   "
241774|NCT00389948|"~     Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic~     stomach contents move into the esophagus from the stomach. This study will investigate the~     safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.~   "
241775|NCT00389935|"~     The purpose of this study is to determine whether Thalidomide is effective in the treatment~     of arteriovenous malformations in the gastrointestinal tract.~   "
241776|NCT00389922|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when~     given together with vinorelbine in treating patients with advanced solid tumors.~   "
241777|NCT00389909|"~     Doxapram is used to stimulate respiration. For a given dose, the fluctuations in~     concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy~     or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of~     this study is to compare a dosage regimen based only on patient's weight, to another one~     using a dosing chart taking into account weight, age and gender.~   "
241778|NCT00389896|"~     The purpose of this study is to see how well simvastatin raises HDL levels in patients with~     Type 2 Diabetes.~   "
241779|NCT00389883|"~     This is a double center, multidisciplinary, prospective, randomized, double-blind, with a~     superiority hypothesis, trial including 100 patients scheduled for resection of a~     supratentorial brain tumour under general anesthesia.~   "
241780|NCT00389870|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Cyclosporine may help irinotecan work better by making tumor cells more sensitive to the~     drug. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether irinotecan is more effective when given with or without panitumumab or cyclosporine~     in treating colorectal cancer.~      PURPOSE: This randomized phase III trial is studying irinotecan to compare how well it works~     when given with or without panitumumab or cyclosporine in treating patients with advanced or~     metastatic colorectal cancer that did not respond to fluorouracil.~   "
241781|NCT00389857|"~     To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from~     healthy children receiving the 2006-2007 formulation of the inactivated, split-virion~     influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA),~     Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).~   "
241782|NCT00389844|"~     The major goals of this study are:~      To implement a self-efficacy based intervention to strengthen efficacy beliefs related to~     exercise, decrease perceived barriers to exercise, and increase exercise behavior and overall~     activity of older women who have sustained a hip fracture.~      To test the effectiveness of the Exercise Trainer component of the intervention on exercise~     behavior, activity, efficacy expectations, barriers to exercise, performance behaviors,~     overall health status, mood, pain, fear of falling, falls and fall-related injuries at 2, 6,~     and 12 months following fracture.~   "
241783|NCT00389831|"~     The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of~     rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.~   "
241784|NCT00389818|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some find cancer cells and help~     kill them or carry cancer-killing substances to them. Others interfere with the ability of~     cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may~     kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with rituximab works in treating patients with newly diagnosed AIDS-related B-cell~     non-Hodgkin's lymphoma.~   "
241785|NCT00389805|"~     RATIONALE: Bortezomib and pemetrexed disodium may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving bortezomib together with pemetrexed~     disodium may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of two different~     schedules of bortezomib when given together with pemetrexed disodium and to see how well they~     work in treating patients with advanced non-small cell lung cancer or other solid tumors.~   "
241786|NCT00389792|"~     The purpose of this study is to determine the safety and efficacy of an investigational~     antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a~     dual chamber pacemaker.~   "
241814|NCT00389402|"~     The purpose of this study is to assess differences in changes in plasma lipids between~     patients on saquinavir/ritonavir or atazanavir/ritonavir in combination with tenofovir~     disoproxil fumarate and emtricitabine as a first-line regimen in patients previously naive~     for antiretroviral therapy. This study is an extension from the SSAR 2004/0002 which~     randomised patients over the same treatment arms.~   "
241787|NCT00389779|"~     This is a randomized, double-blind, placebo- and active-controlled study of a new~     experimental drug called darusentan. Darusentan is not currently approved by the United~     States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this~     drug. The purpose of this study is to determine if darusentan is effective in reducing~     systolic and diastolic hypertension despite treatment with full doses of three or more~     antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan~     (optimized dose), an active comparator, or placebo, administered orally. The treatment period~     for this trial is 14 weeks.~   "
241788|NCT00389766|"~     RATIONALE: Radioisotope therapy, such as iodine I 131 metaiodobenzylguanidine (MIBG),~     releases radiation that kills tumor cells. Drugs used in chemotherapy, such as topotecan,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Topotecan may also make tumor cells more sensitive to iodine I~     131 MIBG. A peripheral stem cell transplant may be able to replace blood-forming cells that~     were destroyed by iodine I 131 MIBG and topotecan. This may allow more iodine I 131 MIBG and~     topotecan to be given so that more tumor cells are killed.~      PURPOSE: This phase II trial is studying how well giving high-dose iodine I 131 MIBG together~     with topotecan and peripheral stem cell transplant works in treating young patients with~     relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma.~   "
241789|NCT00389753|"~     Comparison between use of Aruba Aloë formula F-BC-096 and control.~   "
241790|NCT00389740|"~     The purpose of this study is to compare how well alendronate and raloxifene increase the bone~     density in women who have osteoporosis and have experienced menopause.~   "
241791|NCT00389727|"~     The objective of the study is to assess the feasibility of increasing dose of irradiation~     with IMRT using a SIB approach over 6 weeks.~      The primary endpoint of the study will be acute toxicity assessed during treatment and during~     the first 3 months following the completion of radiotherapy The secondary endpoint will~     include loco-regional control, disease-free survival, survival and late toxicity at 2 years~     after completion of radiotherapy~   "
241792|NCT00389714|"~     Composite resins are presently among the most popular esthetic restorative materials in~     dentistry. These materials offer excellent esthetic appearance, allow for conservative cavity~     preparation and are now becoming widely accepted for clinical use in primary molars 1-23.~     Despite the improvement of their properties, achieved with better materials and incremental~     placing techniques, composite resin restorations appear to have still several drawbacks:~     although similar to amalgam in short terms studies, they have a high long term failure rate,~     mainly due to discoloration, loss of retention and secondary caries3,11,19, are~     time-consuming and technique sensitive, lack anti-cariogenic potential and can be amenable to~     secondary caries at the cervical dentin margins 1, 2.~      Continued interest in providing advance in restorative esthetic materials led to the~     development of new generations of composites. Among the newest material developed is the use~     of minute amount of nanoparticles which convert composites to possess permanent antibacterial~     properties.~      It is of great interest to observe the clinical behavior of this new material when utilized~     in clinical practice. Thus the aims of the present in-vivo study are:~        1. To evaluate the clinical and radiographic performance of the New Restorative System when~          placed with adhesive systems in class II restorations of primary molars.~        2. To assess, by SEM, the micromorphology of the cervical, buccal and lingual margins of~          the proximal surfaces of the restored teeth retrieved after exfoliation or extraction.~        3. To asses, by means of polarized light microscopy, the integrity of the cervical margins~          of the same retrieved teeth.~   "
241793|NCT00389701|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,~     such as dexamethasone, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving bortezomib together with~     dexamethasone may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with~     dexamethasone works in treating patients with multiple myeloma that has relapsed or has not~     responded to treatment.~   "
241794|NCT00389688|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~     Giving combination chemotherapy after surgery may kill any tumor cells that remain after~     surgery. It is not yet known whether combination chemotherapy is more effective before or~     after surgery in treating non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying the side effects of pemetrexed disodium~     and cisplatin and comparing how well they work when given before or after surgery in treating~     patients with stage IB or stage II non-small cell lung cancer that can be removed by surgery.~   "
241795|NCT00389675|"~     This is a double-blind, active-controlled, long-term study of a new experimental drug called~     darusentan. Darusentan in not currently approved by the United States Food and Drug~     Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of~     this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to~     an active control, administered orally.~   "
241796|NCT00389662|"~     To evaluate the effect of wearing the 'Nike Free'Shoe on isokinetic muscle strength of foot~     and ankle and on proprioception the following protocol will be used.~      The test population consists out of students of the physical education department. They will~     at random be divided in three groups. One group will wear the shoe only for daily activities,~     the second group will wear the shoes for the warming up part of the sport classes and the~     control group will not wear the shoe at all. There will be two moments for evaluation: one at~     the beginning of the study and one after four months, during which the shoe will be used. The~     isokinetic strength will be measured with an isokinetic device (Biodex) and the~     proprioception will be evaluated with a force platform (Neurocom Balance Master).~   "
241815|NCT00389389|"~     The primary purpose of this study is to find out what the maximum tolerated dose is for an~     experimental drug called AZD4877 based on the side effects experiences by patients that~     receive AZD4877 on a weekly basis~   "
241816|NCT00389376|"~     The purpose of this study is to determine the safety and tolerability of different dosages of~     silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease.~   "
241797|NCT00389649|"~     This will be a double blind randomized crossover study of patients with congestive heart~     failure and a heart rate dependent upon a permanent pacemaker. Thus, at all times the heart~     rate can be maintained at a set rate by adjusting the settings of the pacemaker. Acute and~     chronic effects of heart rates of 60, 75, and 90 beats per minute will be evaluated. The~     effect of heart rate will be determined by measuring ejection fraction by nuclear~     ventriculography, six minute walk distance, and peak oxygen consumption on a maximal exercise~     test.~   "
241798|NCT00389636|"~     Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic~     foot ulcer condition. The purpose of the study is provide the sponsor with pilot information~     regarding the ability of TheraGauze to promote wound healing on its own and to examine~     synergy with Regranex in the treatment of diabetic foot ulcers.~   "
241799|NCT00389610|"~     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune~     response to kill tumor cells. Giving booster vaccinations may make a stronger immune response~     and prevent or delay the recurrence of pancreatic cancer.~      PURPOSE: This phase II trial is studying the side effects and how well vaccine therapy works~     in treating patients with pancreatic cancer that has been removed by surgery.~   "
241800|NCT00389597|"~     The purpose of this investigation is to establish the safety and effectiveness of the LDR~     Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical~     device. The primary objective of the study is to evaluate the overall success rate of the~     investigational device as compared to the control in the treatment of patients with~     symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels.~     Patients should be without prior cervical fusion between C3 and C7 and unresponsive to~     non-operative conservative treatment for six weeks after symptom onset or have the presence~     of progressive symptoms or signs of nerve/spinal cord compression despite continued~     non-operative conservative treatment.~   "
241801|NCT00389584|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan may make tumor~     cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain~     radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when~     given together with whole-brain radiation therapy and to see how well they work in treating~     patients with brain metastases from solid tumors. (The study of side effects and best dose~     has ended as of 4/15/05)~   "
241802|NCT00389558|"~     The purposes of the study are:~        1. To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used~          for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).~        2. To evaluate whether the bacteria responsible for nosocomial infection is comparable to~          the flora diagnosed at the EPI site.~   "
241803|NCT00389545|"~     Despite the widespread use of effective reperfusion therapies, the patients presenting late~     with large myocardial infarction have poor outcomes. The aim of the study was to investigate~     the safety and efficacy of intracoronary injection of autologous bone marrow-derived~     mononuclear cells (BMNCs) in patients with large myocardial infarction~   "
241804|NCT00389532|"~     To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for~     further analysis by the Food and Drug Administration (FDA), the Center for Disease Control~     and Prevention (CDC) and the World Health Organization (WHO) to support selection and~     recommendation of antigen strains for subsequent influenza vaccines.~   "
241805|NCT00389519|"~     The primary purpose of this study is to evaluate the blood pressure lowering effects of~     ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and~     adolescents aged 6 to 16 years with hypertension.~   "
241806|NCT00389506|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. LMB-2 immunotoxin can find cancer cells and kill them without harming~     normal cells. Giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin may kill~     more cancer cells.~      PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide~     followed by LMB-2 immunotoxin works in treating patients with Hodgkin's lymphoma.~   "
241807|NCT00389493|"~     This study will compare the short- and long-term effectiveness of two common therapies in~     improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive~     disorder.~   "
241808|NCT00389480|"~     Hypothesis:~      AR-67 (formerly DB-67) represents a rationally engineered drug that possesses improved~     stability, toxicity, and efficacy compared to current Food and Drug Administration~     (FDA)-approved camptothecins, based on the extensive research of prior studies. Therefore,~     the investigators hypothesize that AR-67 (formerly DB-67) will be well-tolerated and~     efficacious in phase I clinical trials. This initial phase I trial will establish the maximum~     tolerated dose in humans, establish the toxicity profile, and define the appropriate dose of~     AR-67 (formerly DB-67) for future phase II and III clinical trials.~   "
241809|NCT00389467|"~     The purpose of this study is to compare the effectiveness of treating acute ischemic stroke~     with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours~     of symptom onset to standard medical treatment, and to identify people who might benefit from~     mechanical embolectomy by the appearance of stroke on multimodal computerized tomography (CT)~     or magnetic resonance (MR) imaging.~   "
241810|NCT00389454|"~     Acetaminophen is the most commonly used drug in children. Inhibition of COX-3 in the brain~     has been suggested as the primary central mechanism by which acetaminophen decrease pain and~     possibly fever. However there is very limited data about acetaminophen concentrations in the~     brain and no such data is available for newborns. The objective of the current study is to~     describe concentrations of acetaminophen in the fluid around the brain of infants after~     administration of acetaminophen.~   "
241811|NCT00389441|"~     The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer~     that is resistant to radioactive iodine~   "
241812|NCT00389428|"~     The primary objective of this study is to determine the recommended dose of CPX-351 for use~     in a phase 2 efficacy study in patients with leukemia. Secondarily, the study will assess the~     safety, serious adverse effects and how the body handles CPX-351. Preliminary evidence of~     antitumor activity will also be determined.~   "
241819|NCT00389337|"~     BACKGROUND: In November 2003 the Medical Director at Copenhagen University Hospital,~     Hvidovre, gathered a group of doctors involved in the diagnosis and treatment of patients~     with sepsis.~      AMIS: To develop a fast and reliable tool that can guide the physician in the diagnosis and~     treatment of the septic patient thereby reducing mortality and morbidity. The measurement of~     markers of inflammation, coagulation, infection and specific bacterial antigens in the same~     plasma sample will give insight to the pathogenesis of sepsis and SIRS and the bodies~     responds to the disease.~      MATERIAL AND METHODES: Case-Control study nested in cohort. 300 patients admitted to the~     hospital from 1.01.05 to 01.07.06. Copenhagen University Hospital, Hvidovre, an 800 beds~     hospital, covers a part of Copenhagen with a wide variety in the population's socioeconomic~     and cultural background. For the analysis of markers the luminex 100 lab analysis system is~     used. It utilizes xMAP® technology which enables you to simultaneously assay up to 100~     analytes in a single well of a microtiter plate, using very small sample volumes. Assay~     development of a 15-plex is don In-house.~      COWORKERS & FOUNDING: The following departments at the hospital, are coworkers in the SPEEDI~     study: Clinical Research Unit, Departments of Infectious Disease, Clinical Microbiology,~     Clinical Biochemistry, Gastroenterology (incl. surgery), Intensive Care Unit, Emergency Room,~     and the Hospital Board of Directors. All departments have research experience and a long~     tradition of publication of scientific works. The study received founding for equipment and~     salaries during the first phase of the study from the hospitals Board of Directors.~     Applications to major public foundations in Denmark are awaiting answer. No commercial~     interest are involved in the study.~      FUTURE APPLICATIONS: A second phase of the study including children admitted at the hospital~     is in preparation. The very small sample volume is a great advantage in diagnosing infection~     in children. The applications of the study results will hopefully provide the physician with~     the needed tool for a fast and reliable diagnosis, prognosis and treatment guide for the~     patients suffering from SIRS and sepsis.~   "
241820|NCT00389324|"~     This study will compare the blood level of Gamunex in patients. Patients will take it as an~     injection under the skin or in a vein. The study will compare how safe and tolerable the two~     methods are in the patients. The patients in this study have a defect in their immune system~     from a genetic cause.~   "
241821|NCT00389311|"~     The purpose of this study is to determine if detectable changes in permeability of the lining~     of the colon are caused by either application of HIV microbicide gels or medical procedures,~     such as flexible sigmoidoscopy.~   "
241822|NCT00389298|"~     The purpose of this study is to determine whether a 10-day course of therapy with orally~     administered VCH-759 given at 400-mg, 600-mg or 800-mg three times daily can effectively~     reduce the amount of circulating virus (i.e., viral load) in patients with early-stage~     chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of~     treatment with VCH-759. Blood samples will also be taken to measure the levels of VCH-759~     present in plasma at various time points during the treatment period.~   "
241823|NCT00389285|"~     The purpose of the study is to evaluate whether recombinant IL-21 used in combination with~     sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).~   "
241824|NCT00389272|"~     Fever is one of the most common symptoms in pediatrics and one of the most common reasons for~     visits in pediatricians' office and pediatric emergency departments. Many parents consider~     fever to be the most terrifying symptom.~      Acetaminophen and ibuprofen are both effective and safe treatments for febrile children. In~     order to achieve better temperature control and to avoid toxicity it has been suggested to~     treat febrile children with alternating doses of acetaminophen and ibuprofen. Surveys in the~     USA and Spain found that this practice is very common. However, The safety and efficacy of~     such practice was never described.~      Hypothesis:~      Children who are still febrile after being treated with acetaminophen or ibuprofen will have~     greater temperature decrement if treated with another drug (acetaminophen for those treated~     with ibuprofen and ibuprofen for those treated with acetaminophen) than if treated with~     placebo.~   "
241825|NCT00389259|"~     Organophosphate (OP) compounds are a major threat as chemical warfare agents or in terrorist~     act. OPs are also the active ingredient of many insecticides. Ingestion of insecticides is a~     common cause of death among people who commit suicide in developing countries. OPs poisoning~     also frequently occurs after accidental exposure to agricultural OPs and in children as a~     result of unintentional ingestion.~      The use of competitive inhibitors of acetylcholine other than atropine for patient with~     organophosphate (OP) poisoning is controversial. Because scopolamines' ability to cross the~     blood brain barrier is better than atropine, it has been suggested that scopolamine should be~     used OP poisoned patients who have central nervous system (CNS) manifestations. However there~     is controversy regarding its potential benefit in the treatment of organophosphate poisoning~     in humans. To the best of our knowledge there are no randomised controlled studies on the use~     of scopolamine in humans. This prospective randomised controlled study is aimed to determine~     whether adding scopolamine to the standard treatment of atropine and oximes in patients with~     CNS symptoms of OP poisoning improve the outcome.~   "
241826|NCT00389246|"~     More than 1,000 obese people are screened for genetic mutations (MC4R). Those with positive~     screenings as well as 320 randomly selected people without MC4R mutations are randomized to 2~     consultation types: one including recommendations for eating and physical activity behavior,~     the other with an additional part on genetic determinants and actions in obesity. It is~     hypothesized that obese people with obesity-specific genetic mutations, and obese people with~     a family history of obesity, benefit more if the consultation includes additional elements on~     genetic determinants.~   "
241827|NCT00389233|"~     The study was carried out as a randomised, single-blind, active-controlled, multi-centric,~     phase III study with two parallel treatment groups. The primary efficacy criterion was the~     frequency of effective gut cleansing in each of the two treatment groups (grade A or B~     overall quality of gut cleansing as judged by a blinded expert panel on the basis of~     videotapes recorded during the endoscopic procedure).~   "
241828|NCT00389220|"~     The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system~     with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.~   "
241844|NCT00389012|"~     The purpose of this study is to determine if treadmill training with body weight-support~     (BWST) is more effective at improving walking in individuals post-stroke than a resisted~     leg-cycling exercise program. In addition, we want to determine if training programs that~     combine leg strength training to treadmill walking provide an additional benefit to~     post-stroke walking outcomes.~   "
241845|NCT00388999|"~     MBL deficient patients enrolled in this protocol are scheduled to be treated with~     melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell~     transplant (HSCT) for their multiple myeloma. Patients are randomized to 0.5 mg/kg, 1.0~     mg/kg, or no rhMBL.~   "
242231|NCT00383864|"~     The purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in~     patients with chronic hepatitis C after liver transplantation. The only approved drugs for~     treatment of hepatitis C are pegylated interferon and ribavirin.~   "
241829|NCT00389207|"~     Primary purpose of this study is to compare the efficacy and safety of two different~     nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and~     of atazanavir/ritonavir (Reyataz/Norvir), all on an emtricitabine/tenofovir disoproxil~     fumarate (DF) (Truvada) background. Patients will receive either nevirapine (NVP) 200 mg~     twice daily, or NVP 400 mg once daily , or ritonavir-boosted atazanavir (ATZ/r), all in~     combination with emtricitabine (FTC) and tenofovir DF (TDF).~      All patients receiving NVP will start at 200 mg once daily for 2 weeks, because it has been~     demonstrated that this lead-in dosing regimen reduces the frequency of NVP-induced rash. At~     Visit 3 (Week 2), patients increase the NVP dose to either 200 mg twice daily or to 400 mg~     once daily. Patients receiving ATZ/r will be treated with ATZ 300 mg once daily, boosted by~     100 mg ritonavir (RTV) once daily. Background antiretroviral therapy for all patients~     consists of one tablet of Truvada. Treatment duration is 48 weeks (primary endpoint) with an~     extension to 144 weeks. Patients may also participate in the metabolic sub-study, comparing~     NVP and ATZ/r for signs and symptoms of lipodystrophy and serum lipid/glycaemic~     abnormalities.~   "
241830|NCT00389194|"~     The main objective of the study is to assess changes in fat distribution over 48 weeks of~     treatment in patients who currently successfully use zidovudine (AZT) and lamivudine (3TC) as~     part of their regimen and who will either continue these antiretrovirals or who will switch~     these antiretrovirals to tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Each of~     these medications is commonly used for the treatment of HIV-1 infection.~   "
241831|NCT00389181|"~     The purpose of this study is to determine if medical management is better than invasive~     therapy for improving the long-term outcome of patients with unruptured brain arteriovenous~     malformations.~   "
241832|NCT00389168|"~     The renin-angiotensin-aldosterone system has been implicated in the control of structural~     changes of the heart and the vasculature, beyond the effects on blood pressure.~      This projects examines the importance of the renin-angiotensin-aldosterone system and the~     sympathetic nervous system in the control of cardiac and vascular structure and function in~     subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were~     randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48~     weeks. Repeat investigations of blood pressure, structure and function of the heart and the~     vascular tree, and neurohormones were performed. Two control groups, consisting of~     normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also~     examined for comparison.~   "
241833|NCT00389155|"~     The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in~     combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be~     treated with cisplatin. This study will help to determine whether vinflunine in combination~     with gemcitabine will extend the time period until further growth of the tumor more than~     gemcitabine alone.~   "
241834|NCT00389142|"~     Interstitial cystitis (IC), also called painful bladder syndrome (PBS), or chronic pelvic~     pain syndrome(CPPS) is a common condition with no known cause or cure. Twin studies and~     family accounts have suggested that the condition may be genetic or passed down (inherited)~     from one generation to another.~      In this study, we are collecting genetic material and medical information from families in~     North America in an attempt to identify genetic factors that may cause IC/PBS/CPPS. We are~     enrolling families and individuals with IC/PBS/CPPS and their family members (both family~     members with and without IC like symptoms).~   "
241835|NCT00389129|"~     Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It~     has been speculated that these patients might be resistant to aspirin, and studies have~     indicated that this phenomenon is related to a less favourable prognosis. At present, no~     international consensus exists on how to measure aspirin resistance. The purpose of this~     study is to compare different methods for detecting aspirin resistance. A classic but~     cumbersome way of evaluating platelet function will be compared to newer, easy-handling~     point-of-care tests. We hypothesize that one or more point-of-care tests will prove to be~     superior to the classic platelet function test in detecting aspirin resistance.~   "
241836|NCT00389116|"~     Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20%~     of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions~     are the consequence of intraperitoneal postoperative adhesions. They constitute an extremely~     frequent pathology, leading to a high rate of hospital admissions and money expense.~      Management of small bowel obstruction is based on 2 options: either a surgical approach where~     all patients are operating on, or a conservative treatment in which surgery is proposed in~     case of failure of medical treatment. The surgical approach leads to operate on an excessive~     rate of patients while the medical approach increases the risk of increased small bowel~     resection, morbidity rate or hospitalization duration.~      In order to improve the management of small bowel obstruction, it seems necessary to better~     distinguish patients that need an emergency surgical procedure from patients in which medical~     treatment will be useful. Many studies have been performed to investigate the value of~     imaging in the management of small bowel obstruction, using abdominal X-ray, oral~     gastrografin administration or CT-Scan.~      The aim of this study is to analyse the effect of a systematic performance of imaging~     investigation on the management of patients presenting with a postoperative small bowel~     obstruction.~      All patients suffering from a postoperative small bowel obstruction will be included in this~     study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral~     water administration while in group SG, Patients will have CT-Scan and oral gastrografin~     administration The major end point of this study is to analyse whether imaging examination~     can reduce the need for a surgical approach or the rate of small bowel resection and to~     determine its influence on fasting time or hospitalization duration~   "
241837|NCT00389103|"~     purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine~     injections in healthy adults that are 18-35 years of age with a history of mild to moderate~     Atopic Dermatitis.~   "
241838|NCT00389090|"~     This is an open-label, multicenter, phase II trial, assessing the antitumor activity, and~     safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant~     anaplastic glioma.~   "
241839|NCT00389077|"~     This is a study of the drug perifosine for patients who have no standard treatment options.~     This study is designed to identify which cancer types respond to perifosine, and determine~     which regimen of perifosine is most effective in each one. Patients with either solid tumors~     or with lymphomas for whom this protocol represents reasonable or optimal treatment will be~     randomized to receive either perifosine 100 mg daily or 900 mg weekly until disease~     progression. Based on currently available data it is anticipated that these doses should be~     easily tolerated by most patients.~   "
241840|NCT00389064|"~     The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR)~     quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve~     elderly patients with generalised anxiety disorder.~      PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The~     SR designation was changed to XR after consultation with FDA.~   "
241846|NCT00388986|"~     This study will assess the potential pharmacodynamic and potential pharmacokinetic~     interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not~     adequately controlled with glyburide as standard prescribed therapy. Patients will enter the~     study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK~     Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK~     Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and~     glyburide treatment re-started. The anticipated time on study treatment is <3 months, and the~     target sample size is <100 individuals.~   "
241847|NCT00388973|"~     The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR)~     quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve~     depressive symptoms in elderly patients with major depressive disorder.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
241848|NCT00388960|"~     The purpose of the study is to document the activity and safety of single agent amrubicin,~     amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line~     treatment in extensive disease small cell lung cancer.~   "
241849|NCT00388947|"~     This registry was observational (only collected information typically noted by the surgeon~     when their patients were routinely seen); there was no change to the care the patient~     received as a result of being part of the registry). Data collection focused on the surgical~     outcomes of AMS prolapse products.~   "
241850|NCT00388934|"~     Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express)~     and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery~     disease.~   "
241851|NCT00388921|"~     Vitamin A deficiency is an important health problem globally including Bangladesh. The~     problem is greater among under-five children, particularly in malnourished. Vitamin A~     supplementation reduces morbidity from diarrhoeal diseases and also prevents future diarrhoea~     episodes. However, there are conflicting reports on the role of vitamin A supplementation on~     morbidity from acute lower respiratory infections (ALRI) including pneumonia. In~     non-malnourished children supplementation has been reported to be associated with increased~     incidence and morbidity of ALRI. The WHO committee[1] has reviewed both the risk and benefit~     of mega dose (200,000 IU) vitamin A supplementation during acute illness particularly~     diarrhoea, irrespective of the nutritional status of under-5 children and recommended vitamin~     A supplementation in areas where vitamin A status is low. In Bangladesh mega dose (200,000~     IU) of vitamin A is routinely supplemented to under-5 children every 6 months. Absorption of~     vitamin A precursors from the GI tract is reduced in severely malnourished children, who are~     also lacking in retinol binding protein (RBP), required for transportation of retinol to~     target tissues. Thus it is established that a significant portion of the supplemented vitamin~     A is excreted in feces and urine of malnourished children. The excretion of vitamin A~     increases substantially during acute infections including diarrhoeal diseases. On the other~     hand, due to reduced RBP, concentration of free vitamin A increases in the body resulting in~     the possibility of adverse events including pseudotumor cerebri. It has recently been~     observed that low-dose daily supplementation of vitamin A to malnourished children produces a~     better effect on recovery from acute illness and also in preventing infectious diseases among~     under-five children. However, the limitations of those studies included a small sample size,~     delayed assessment of retinol after supplementation among the others. Thus WHO felt that the~     issue needs to be addressed in a well-designed clinical trial. We hope that our proposed~     study will enable us to compare the efficacy of low-dose daily administration of vitamin A~     with that of initial mega dose followed by daily low dose of vitamin A in malnourished~     children presenting with acute diarrhoeal diseases with or without ALRI. If the results of~     this study indicate that the daily low-dose has similar efficacy to that of the currently~     recommended mega dose followed by daily low-dose of vitamin A, would have important~     programmatic implications.~   "
241852|NCT00388908|"~     Osteoporosis is a common and progressive condition that leads to broken bones (fractures),~     which cause pain, disability, deformity, and even death. There are new treatments available~     that can decrease the risk of a fracture by 50%, and the people who benefit the most are~     those with osteoporosis who have already had a fracture, like a vertebral (spine) fracture.~     Vertebral fractures are usually silent, and ~20% of people over the age of 60 years have~     had one although they don't know it. Many of these people have had chest x-rays done for~     other reasons, and these x-rays can incidentally detect these silent fractures. Although most~     people with a vertebral fracture should be tested and treated for osteoporosis, studies~     demonstrate that less than one-quarter of older people with a vertebral fracture are ever~     investigated or even treated. This reflects a gap between evidence-based best practice and~     everyday practice in the community. The proposed research addresses this care-gap by using a~     quality improvement intervention that uses chest x-rays done in the Emergency Department to~     remind family physicians about osteoporosis while providing them with evidence-based~     treatment guidelines - with or without educating and empowering patients about osteoporosis.~     The effectiveness of this intervention will be compared to usual care in a controlled trial.~     The intent of this research is to improve quality of care for patients at high risk of~     fracture, by increasing rates of testing and treatment of osteoporosis.~   "
241853|NCT00388895|"~     % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment~   "
241854|NCT00388882|"~     The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with~     tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2~     actuations qid in COPD patients currently prescribed Combivent® MDI.~   "
241855|NCT00388869|"~     CT of the abdomen is a very common examination performed for various indications.One of the~     common findings is vascular calcifications including calcifications of the renal~     arteries.Calcifications in the carotid arteries and coronary arteries are good predictor for~     obstructive atherosclerotic disease.Stenosis of the renal arteries can cause symptomatic or~     asymptomatic hypertension with subsequent clinical sequelae. Therefore early diagnosis of~     this condition is imperative.~      The goal of our study is to investigate the correlation between incidental calcifications of~     the renal arteries in CT examinations and the presence of actual stenosis of these vessels in~     patients with and without hypertension.~   "
241856|NCT00388856|"~     The purpose of this study is to investigate antioxidants supplementation in pregnant women~     with low antioxidant status at 10-12 weeks gestation age in relation to adverse pregnancy~     outcome in randomized prospective study.~   "
241857|NCT00388843|"~     The purpose of the study is to determine if short term (6 months) treatment with statins to~     lower low-density lipoprotein (LDL) in vascular disease patients with carotid plaque will be~     associated with a measurable reduction in carotid plaque volume using 3 Tesla MRI. The~     researchers will correlate the change in plaque volume to degree of LDL lowering. The~     researchers will also study if brief treatment will lead to change in plaque composition. The~     researchers will compare the change in plaque volume measured by 3T MRI with plaque burden~     measured by ultrasound.~   "
241858|NCT00388830|"~     The purpose of this study is to determine whether fasting for 8 hours prior to~     ultrasonography for cholelithiasis (gallbladder pain) is needed.~   "
241860|NCT00388804|"~     Primary Objective:~        -  To assess the possible improvement in prostate specific antigen (PSA) outcome of short~          course androgen suppression therapy in conjunction with dose-escalation intensity~          modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton~          therapy over IMRT, 3D-CRT, or proton therapy alone in prostate cancer patients~          traditionally considered at intermediate risk for PSA failure following conventional~          local therapy. PSA failure will be the primary endpoint.~      Secondary Objectives:~        -  To assess local control, freedom from distant metastasis, and overall survival.~        -  To study the impact of radiation therapy and/or hormone therapy on health-related~          quality of life measures using the Expanded Prostate Cancer Index Composite-Short Form~          12-American Urological Association Symptom Index (EPIC-SF12-AUASI:~          http://roadrunner.cancer.med.umich.edu/epic/).~        -  To assess prognostic value of pretreatment serum testosterone as well as the decrease in~          hemoglobin from neoadjuvant hormone therapy.~        -  To assess prognostic value of pretreatment biomarkers on subsequent post-treatment~          clinical outcomes.~   "
241861|NCT00388791|"~     The purpose of this study is to compare the efficacy of Systane Free to Saline in decreasing~     the symptoms of dry eye after aggressive therapy. As a principal outcome measure, we are~     using the modified Schein dry eye symptomatology questionaire to determine whether any~     improvement in signs is mirrored by improvement in the Schein Score. Up to 30 dry eye~     subjects will be dosed six times per day for one month. The typical clinical signs will be~     onmitored (e.g., corneal staining) along with dyrness symptoms. The hypothesis is that an~     optimized drop, Systane Free, will be more effective than saline solution in improving dry~     eye signs and symptoms.~   "
241862|NCT00388778|"~     The purpose of this study is to compare the safety and efficacy of twice daily~     subantimicrobial dose doxycycline 20mg with daily doxycycline 100mg in treatment of mild and~     moderate Acne.~   "
241863|NCT00388765|"~     This study is designed to collect lung washing samples and small pieces of tissue (biopsies)~     from the lungs of people who do not have any allergies or asthma. These samples will be used~     by researchers in the future as control samples to compare to samples from people with~     chronic lung diseases such as allergic asthma or emphysema. Control samples are samples are~     very important in laboratory experiments so that the researchers can tell what may be labeled~     as different or abnormal in samples from people with lung disease.~   "
241864|NCT00388752|"~     The purpose of this study is to identify the best treatment sequence and combination of~     acupuncture points for the treatment of phantom limb or residual limb pain in the~     traumatic/surgical amputee.~   "
241865|NCT00388739|"~     Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma~     educational intervention in the pediatric Emergency Department (ED) with anti-inflammatory~     medication will result in an improvement of ED revisits (and unscheduled return visits).~     Chronic management intitiation in conjunction with an asthma educational intervention in the~     pediatric ED with anti-inflammatory medication will also result in improved Quality of Life~     measure.~      Specific aims: 1. To demonstrate that the initiation controller medication therapy in~     conjunction with asthma education will result in:~        1. Decreased return ED visits (or unscheduled primary care physician visits) as compared to~          a control group over a 12 month period~        2. Improved Quality of Life as measured by Bukstein’s ITG Quality of Life measure.~           2. To describe the relationship of the initiation of controller medication therapy in~          conjunction with asthma education with well child visits, missed school/daycare days and~          behavioral capabilities.~           Objective: To determine the impact of beginning chronic asthma medication regimens after~          an educational intervention in the ED in pediatric patients 1-18 years of age with mild~          to moderate persistent asthma.~           Long-term goal/purpose: To demonstrate the success of a model of care that utilizes the~          emergency department physician to initiate National Asthma Education and Prevention~          Program (NAEPP) guided chronic asthma therapy in children 1-18 years of age. This model~          will attempt to bridge the gap in initiation of chronic asthma therapy currently left by~          a failure of both emergency department and primary care physicians.~   "
241866|NCT00388726|"~     The purpose of this study is to compare Overall Survival (OS), Progression Free Survival~     (PFS), objective tumor response rate, duration of response, and safety in patients treated~     with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally~     recurrent or metastatic breast cancer.~   "
241867|NCT00388713|"~     Radiation induced accelerated atherosclerosis is a well known entity that occurs in different~     regions, according to the therapy delivered.It is usually begins to be clinically evident~     several years after the radiation incident, as there is sufficient functional reserve to~     these vessels.Our proposal is aimed to better characterize this side effect. For that~     purpose, we have chosen to study women who received radiation to the breast, in which part of~     the carotid in the irradiated side was in the high energy radiation field. We will use Intima~     Media Thickening ultrasound to study the pattern of atherosclerosis plaque formation in~     radiated carotid arteries as compared to non-irradiated carotid arteries in women who are~     receiving radiation therapy for breast cancer.~   "
241868|NCT00388700|"~     The purpose of this clinical trial is to determine whether the combination of 5-fluorouracil~     (5-FU) plus a DAVANAT (carbohydrate polymer) along with Avastin and Leucovorin (LV) is~     beneficial in treating colorectal cancer in patients unable to tolerate intensive~     chemotherapy.~   "
241869|NCT00388687|"~     The aim of this study is to visualize the tumor hypoxic tissue, the potential quantitative~     changes and the biological behavior of cervical carcinoma (primary and / or lymph nodes)~     before, during and after radiochemotherapy with the novel hypoxia PET tracer 18FAZA.~   "
241870|NCT00388674|"~     The purpose of this study is to prospectively assess the long-term outcomes (benefits and~     risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for~     the treatment of chronic HBV infection. For the China substudy, patients randomized to~     entecavir will have safety and efficacy assessments performed during the first year of the~     study.~   "
241944|NCT00387686|"~     The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM~     administered at the fracture site via percutaneous injection, in combination with standard of~     care, accelerates fracture union and return to normal function in subjects who have a closed~     diaphyseal tibial fracture when compared to standard of care alone.~   "
241871|NCT00388661|"~     Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis~     patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For~     a good regulation of these circadian rhythms a uniform external synchronisation is necessary.~     This is the synchronisation of the biological clock of our body by light and other~     influences. In case of a disturbance of the external synchronisation, due to for example naps~     during the day or wake periods at night, internal rhythms can be unlinked. As a result a~     weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis~     patients have sleep problems. Their sleep latency is prolonged. They often take a nap during~     the day and their sleep efficiency is poor. There has only been one study on the melatonin~     rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of~     dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this~     study no link was made between melatonin rhythm and the nature and severity of possible sleep~     problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm,~     exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal~     biological clock and a better quality of life.~      The aim is to improve quality of life of hemodialysis patients with a placebo-controlled~     study with melatonin to investigate if exogenous melatonin can improve sleep problems and on~     the longer term improve quality of life (and secondary morbidity) of dialysis patients.~   "
241872|NCT00388648|"~     There are no solid data on the real advantage of an early start of dialysis, as suggested by~     the DOQI guidelines. Uremic patients frequently have a poor nutritional status. However, we~     cannot distinguish between the detrimental effect on nutrition of too low a residual renal~     function or too long a period of low protein-diet, per se. However, it appears that a~     very-low-protein diet (VLPD) supplemented with essential amino acids and keto-analogs of~     amino acids, and with an adequate quantity of calories, can prevent hypoalbuminemia at the~     start of dialysis and can slow the progression of chronic renal failure.~      EDTA and USRDS data suggest that most patients starting dialysis nowadays are elderly, who~     also have the highest incidence of morbidity and mortality. Moreover, hospitalization rate~     becomes higher after the start of dialysis compared to the pre-dialysis period.~      Can an aminoacid-supplemented VLPD, prolonged beyond the GFR limits suggested by DOQI, offer~     elderly patients better survival and better quality of life than dialysis? The answer can~     only come from a prospective, randomized trial, in elderly patients, starting at the GFR~     values suggested by the NKF-DOQI for starting dialysis, comparing outcomes with a vegetarian~     VLPD supplemented with a mixture of keto-analogs of amino acids and essential amino acids,~     and with dialysis.~   "
241873|NCT00388635|"~     This protocol is planned as a multicentric, national, open-label trial designed to evaluate,~     first, optimal dose of Velcade® (Bortezomib) in combination with melphalan and prednisone.~     After optimal dose is known, the second aim is evaluate safety and tolerance of V-MP plan, in~     respond terms, in a cohort of 60 patients. Finally, the entire results will be compared with~     those obtained from a series of 100 patients, all of them over 70 years old, diagnosed of~     Multiple Myeloma belonging to the GEM protocol finished in May 2003~   "
241874|NCT00388622|"~     The aims of this randomized, clinical trial are to develop and test a multileveled~     pharmacy-based program to improve the care of patients with heart failure. Risk factors for~     deterioration of heart failure will be determined including poor adherence to medication.~   "
241875|NCT00388609|"~     The purpose of this study is to learn if BMS-646256 can cause weight loss in men and women~     who are:~        -  overweight with high blood pressure or high cholesterol or~        -  obese~      The safety of this treatment will also be studied~   "
241876|NCT00388596|"~     The first purpose of this study is to determine if taking SB-751689 along with Rosuvastatin~     (CRESTOR) or Atorvastatin (LIPITOR) will change how Rosuvastatin or Atorvastatin are absorbed~     and eliminated from the body. Rosuvastatin and Atorvastatin are prescription medications used~     to treat patients with high cholesterol. Patients who would take SB-751689 for osteoporosis~     might also take Rosuvastatin or Atorvastatin for high cholesterol. In an earlier study,~     SB-751689 was shown to lower the blood levels of Rosuvastatin when the two drugs were taken~     at the same time. Lower blood levels of Rosuvastatin could mean that it would not be as~     effective in lowering cholesterol. In this study SB-751689 will be taken alone, Rosuvastatin~     will be taken alone, SB-751689 and Rosuvastatin will be taken together, and SB-751689 will be~     taken 12 hours before Rosuvastatin is taken. This study will help determine if the two drugs~     should be taken 12 hour apart to prevent lower Rosuvastatin blood levels. Atorvastatin will~     be taken alone and at the same time as SB-751689 to determine if Atorvastatin blood levels~     are lower when taken at the same time as SB-751689.~      A second purpose of this study is to determine if taking another drug called Ketoconazole~     (Nizoral) along with SB-751689 will change how SB-751689 is absorbed and eliminated from the~     body. Ketoconazole is a prescription medication used to treat patients with fungal and yeast~     infections.~   "
241877|NCT00388583|"~     As a result of the safety and immunogenicity data generated from earlier dose-ranging~     studies, the present formulation has been selected for further development in the elderly.~      Primary Objective:~      To compare the immunogenicity in subjects receiving investigational Fluzone with those of~     subjects receiving standard Fluzone®.~      Secondary Objectives:~      Immunogenicity:~      To describe the immunogenicity in subjects receiving investigational Fluzone and standard~     Fluzone®.~      Safety:~      To evaluate and describe the safety profile of investigational Fluzone in terms of solicited-~     and unsolicited adverse events and serious adverse events post-vaccination.~   "
241878|NCT00388570|"~     The purpose of this study is to demonstrate substantial equivalence between two medical~     devices which measure nitric oxide in exhaled breath, NIOX MINO® and NIOX® in Symptomatic~     Asthmatic Adults and Children.~   "
241879|NCT00388557|"~     The purpose of the study is to test how ketoconazole affects with handling of vinflunine by~     the body which might affect how much vinflunine is in the blood stream and for how long~   "
241880|NCT00388544|"~     Many persons with dementia exhibit behaviors that caregivers find difficult to manage. The~     purpose of this study is to test the effectiveness of individualized recreational activities~     for reducing agitation and passivity in persons with dementia.~   "
241881|NCT00388531|"~     The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.~   "
241882|NCT00388518|"~     This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of~     aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6~     treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active~     comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po~     daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on~     study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
241883|NCT00388505|"~     This study compares the safety of the tobramycin solution for inhalation with the tobramycin~     dry powder formulation, used with a simple inhaler~   "
241884|NCT00388492|"~     The goal of this study is to evaluate the proportion of subjects both antiretroviral~     experienced and virologically suppressed on lopinavir/ritonavir (LPV/r)400/100mg twice daily~     who maintain viral suppression after switching to lopinavir/ritonavir (LPV/r)800/200mg once~     daily.~      The hypothesis for this study is that the majority of subjects will remain virologically~     suppressed with once daily dosing versus twice daily dosing and therefore quality of life~     will be improved with the once daily dosing of lopinavir/ritonavir (LPV/r)800/200mg.~   "
241885|NCT00388479|"~     Patients undergoing major abdominal surgery are at highest risk for developing postoperative~     ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal~     distention and bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage~     or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will~     test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of~     surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery~     (bowel resection or abdominal hysterectomy).~   "
241886|NCT00388466|"~     The purpose of this study is to evaluate the effects of whole body vibration (WBV) on muscle~     function in adult CF-patients.~   "
241887|NCT00388453|"~     The purpose of this study is to establish the clinical application of a new device that~     records pH changes in the hypopharynx. The investigators also aim to compare the consistency~     of distal esophageal pH with hypopharyngeal pH using both the short and the long~     catheters in patients.~   "
241888|NCT00388440|"~     To evaluate the safety and immunogenicity of GSK Biologicals' live attenuated MMR vaccine~     (Priorix) in a local population in Singapore. The vaccine was administered as a single dose~     to healthy children (12-18 months of age) and blood samples were collected at two time points~     (before vaccination and after vaccination).~   "
241889|NCT00388427|"~     This is an open-label, safety study of cetuximab and differing dose levels of dasatinib in~     adult patients with advanced solid malignancies. Cetuximab will be administered as an~     intravenous infusion weekly. Dasatinib will be taken orally, once a day, on a continuous~     schedule at differing dose levels. The primary objective of this study is to determine the~     toxicities and the maximum tolerated doses of dasatinib when combined with cetuximab for the~     treatment of advanced solid tumors.~   "
241890|NCT00388414|"~     Duloxetine has recently been shown to be effective in reducing the pain in chronic pain~     patients. Duloxetine is known to exert a central mechanism, however the precise human brain~     structures responsible for mediating its pain-relieving properties are not known. We will use~     functional magnetic resonance imaging (FMRI) to investigate the neural and functional~     correlates of pain.~   "
241891|NCT00388401|"~     Patients undergoing major abdominal surgery are at highest risk for developing postoperative~     ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal~     distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or~     inability to pass flatus or stool; and inability to tolerate a solid diet. This study will~     test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of~     surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery~     (bowel resection or abdominal hysterectomy).~   "
241892|NCT00388388|"~     This randomized, double-blind, parallel group, two-centre pilot study will test the~     hypothesis that subjects who are otherwise healthy but fulfill the criteria for a diagnosis~     of pre-hypertension and pre-diabetes will have regression or reduced progression of~     hypertension-associated changes in their resistance arteries if their blood pressure is~     controlled for 6 months with losartan, whereas similar subjects whose blood pressure is~     equally well controlled using hydrochlorothiazide will have significantly less improvement of~     the changes in their resistance arteries.~   "
241893|NCT00388375|"~     The purpose of this study is to determine if emergency room physicians can use bedside~     ultrasound to quickly determine the proper placement of a central venous catheter and to~     evaluate for complications such as a punctured lung.~   "
241894|NCT00388362|"~     To study the effectiveness of an immunosuppressive drug sirolimus, in the treatment of~     chronic graft versus host disease in combination with prednisone.~   "
241895|NCT00388349|"~     This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood~     stem cell (PBSC) rescue for Hodgkin's Disease~   "
241896|NCT00388336|"~     The purpose of this study is to evaluate the effectiveness and safety of Epoetin alfa~     administered at 60,000 Units every two weeks in cancer patients who are not receiving~     chemotherapy or radiation therapy.~   "
241908|NCT00388180|"~     The investigational drugs administered in this study activate proteins called PPARs. Data in~     the scientific literature on PPARs, as well as animal data and early clinical data generated~     by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its~     use of fatty acids for energy, and lead to a reduction in body fat. There are also data to~     suggest a role for PPARs in regulating lipid (e.g., cholesterol) levels and inflammation.~     These and other activities of PPARs are being further explored in this clinical study.~   "
241909|NCT00388167|"~     We wanted to determine the efficacy and the safety of caspofungin acetate (CANCIDAS®) in the~     treatment of invader fungal infection (IFI) specifically, Invasive Candidiasis (CI) in adults~     patients without neutropenia and Invasive Aspergillosis (AI) in adults patients who are~     refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of~     amphotericin B, and/or itraconazole).~   "
241910|NCT00388154|"~     Primary Objective:~        -  To estimate the antitumor activity of the combination of gemcitabine and cisplatin in~          patients with advanced (stage III or IV) or recurrent endometrial cancer.~      Secondary Objective:~        -  To determine the nature and degree of toxicity of the combination of gemcitabine and~          cisplatin in this cohort of patients.~   "
241897|NCT00388323|"~     The histological characteristics of alcoholic liver disease (ALD) and non-alcoholic~     steatohepatitis (NASH) related to overweight and obesity suggest the presence of partly~     common physiopathological mechanisms. We reported that the ponderal overload was an~     independent risk factor of alcoholic cirrhosis. The adipose tissue was considered for a long~     time as a simple place of storage of fat. However, it is now recognized that the adipose~     tissue can secrete cytokines called ADIPOKINES.~      The adipose tissue can secrete others cytokines such as TNF-alpha, IL6, IL10 and IL1-Ra.~     Increase in the production of the leptin and TNF-alpha by the adipose tissue after alcohol~     administration in the rat, as well as the role of leptin in inflammation and liver~     fibrogenesis in the murine model of chemical hepatotoxicity strongly suggest that activation~     of adipocytes by alcohol can explain the strong correlation observed between the body mass~     index (BMI) and the severity of ethanol-induced liver injury. Conversely, it was suggested in~     a murine model that the reduction in adiponectin production would sensitize the liver with~     the toxicity of alcohol. The PPAR alpha and gamma are the receptors which play a role both in~     inflammation and glucide and lipid metabolism. Taking into account the inhibiting role of~     PPAR alpha on the proliferation of the hepatic stellate cells, responsible for the fibrosis,~     the PPAR could also be implied in the relation between the overweight and the hepatic~     fibrosis in the alcoholic.~   "
241898|NCT00388310|"~     To evaluate the effective duration (in days) to clinical improvement of outpatient antibiotic~     regimens in the treatment of superficial abscesses caused by MRSA in patients that present to~     the emergency department.~   "
241899|NCT00388297|"~     The purpose of this study is to determine whether treating women, who are diagnosed with a~     mild imbalance of thyroid hormones during pregnancy, with thyroid hormone replacement affects~     their children's intellectual development at 5 years of age.~   "
241900|NCT00388284|"~     This trial is designed as a prospective, multi-center, randomized, double blinded clinical~     trial to evaluate the safety and efficacy of the Thrombin VSI. An immunological sub-study to~     assess antibody and coagulation changes in the subjects following exposure to the Vascular~     Solutions Diagnostic Duett Pro manufactured with Thrombin VSI and Thrombin JMI will be~     conducted as a component of this trial with a subset of the enrolled study subjects.~      Two hundred seventy (270) subjects will be enrolled in this trial. A minimum of 50% of the~     subjects will be interventional subjects and up to 50% will be diagnostic subjects. All 270~     subjects will provide blood specimens at baseline and at the 30 day follow-up visit for~     evaluation in the immunologic sub-study. Within the 270 subjects enrolled, a minimum of 45~     subjects treated with the Thrombin VSI and a minimum of 45 subjects treated with the Thrombin~     JMI will provide blood specimens at the 60 day follow-up visit to be evaluated in the~     immunologic sub-study.~      The primary efficacy objective is to demonstrate that the device time-to-hemostasis for the~     study group treated with the sealing device manufactured with Thrombin VSI is non-inferior to~     the study group treated with the sealing device manufactured with Thrombin JMI.~      The primary safety objective is to demonstrate a device-related major complication rate for~     the study group treated with the sealing device manufactured with Thrombin VSI that is~     non-inferior to the device-related major complication rate observed for the study group~     treated with the sealing device manufactured with Thrombin JMI.~   "
241901|NCT00388271|"~     Urinary tract stones may form in the kidneys or along the ureteric tracts and when left~     untreated, may result in complications such as pain, bleeding, infection and obstruction.~     ESWL (extra-corporeal shock wave lithotripsy) has been shown to be an effective and safe~     method of treatment for kidney and ureteric stones in-situ. In our centre, ESWL is done on an~     outpatient basis with oral pain killers in the weeks following treatment. Patients are also~     instructed to increase their fluid intake during this period to expedite the clearance of~     stone fragments. There have been studies to show that pain caused by stones is due to smooth~     muscle spasm along the ureters, possibly mediated by alpha-receptors. Alpha-blockers have~     been shown to improve the expulsion of stones and also improve pain relief when used alone,~     or together with ESWL treatment. In our study, we seek to investigate if alpha-blocker~     therapy (Alfuzosin) increases stone free rates and improves pain control after ESWL for renal~     and ureteric stones. The potential benefits include a higher rate of stone clearance and~     better pain control~   "
241902|NCT00388258|"~     Patients undergoing major abdominal surgery are at highest risk for developing postoperative~     ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal~     distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or~     inability to pass flatus or stool; and inability to tolerate a solid diet. This study will~     test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of~     surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery~     (bowel resection or abdominal hysterectomy).~   "
241903|NCT00388245|"~     REHEAT 2 study is designed as a prospective, randomised trial comparing two strategies of~     myocardial revascularisation (PCI vs CABG) in patients with ischemic cardiomyopathy and low~     left ventricular ejection fraction.Patients will undergo in random way PCI or CABG procedure.~     The aim the study is to assess the improvement of left ventricle systolic function and~     comparing recent (30 days) and late (12 months) results of surgical (CABG) and percutaneous~     (PCI) revascularization.~   "
241904|NCT00388232|"~     The study was designed to obtain some baseline data on COPD in Malatya region of Turkey.~   "
241905|NCT00388219|"~     The purpose of this study is to determine whether Transtec (R) PRO 70 µg/h and a new~     buprenorphine patch formulation lead to same plasma levels of buprenorphine after single dose~     application~   "
241906|NCT00388206|"~     This is an observational study designed to follow patients with metastatic or locally~     advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant~     squamous histology) who are receiving Avastin in combination with first-line chemotherapy.~     Second-line metastatic CRC patients are also eligible. Patients who started their Avastin~     containing therapy <4 months prior to enrollment are eligible.~   "
241907|NCT00388193|"~     The purpose of this clinical trial is to prove the efficacy of the following new regimen~     treatment:~        -  Administration of anti-CD20 (Rituximab) combined with chemotherapy.~        -  Combined treatment with high doses of methotrexate and high doses of cytarabine with~          conventional cytostatics (block C)~        -  Prophylactic administration of G-CSF after all chemotherapy cycles~        -  local irradiation after 6 cycle if CNS was affected or if there are residual tumour~   "
241912|NCT00388128|"~     The purpose of this study is to evaluate the change in Walking capacity after an intake of~     caffeine. The study design is cross-over and follow-up of 80 patients with leg pain caused by~     narrowing of their leg arteries, Peripheral Vascular Disease (PAD), stage II. Half of all~     will be revascularised, follow up will be after 3 months. It is hypothesized that caffeine~     (6mg/kg) can be a cheap, safe drug before walking exercise. Primary endpoint is maximum~     walking distance (MWD), treadmill-testing,(constant load, 0%,2m/h). Secondary endpoints are~     pain free walking distance (PWD), maximum muscle strength, endurance, reaction speed,~     balance, cognitive function, health related quality of life (SF-36).~   "
241913|NCT00388115|"~     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor~     cells. Giving radiofrequency ablation before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~      PURPOSE: This clinical trial is studying how well radiofrequency ablation followed by surgery~     works in treating patients with early invasive breast cancer or ductal carcinoma in situ.~   "
241914|NCT00388089|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving bortezomib together with topotecan may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and~     topotecan in treating patients with advanced solid tumors.~   "
241915|NCT00388076|"~     Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with~     TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib~     (patients separated in each part). Toxicity monitoring will enable us to find the largest~     dose of pazopanib daily that can be safely given in combination with the chemotherapy agents~     TAXOL and PARAPLATIN, and with lapatinib, as well as what side effects are likely to manifest~     when these agents are given together and whether the combination of pazopanib with~     chemotherapy, helps to treat different types of cancer. Another objective is to find out how~     much pazopanib, TAXOL, PARAPLATIN and lapatinib are in the blood at specific times after the~     agents are given. Collecting the blood samples requires that the patients remain in the~     vicinity of the clinic overnight on 2 occasions.~   "
241916|NCT00388063|"~     This study will evaluate the safety and efficacy of atiprimod treatment in patients with low~     to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable~     local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing)~     despite standard therapy (octreotide) or progression of neuroendocrine tumor(s).~   "
241917|NCT00388050|"~     The purpose of this study is to examine how different ways of sharing information about~     diabetes medication treatment options with patients can affect their choices and health.~   "
241918|NCT00388037|"~     This phase II trial studies the side effects and how well sunitinib malate works in treating~     patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.~     Sunitinib malate may inhibit the ability of cancers to grow blood vessels, something they~     need to grow. It may also shrink tumors.~   "
241919|NCT00388024|"~     RATIONALE: Imaging procedures, such as PET scan and CT scan, may help doctors predict a~     patient's response to treatment and plan the best treatment.~      PURPOSE: This clinical trial is studying how well PET scans and CT scans show response to~     treatment in patients with locally advanced head and neck cancer undergoing chemotherapy and~     radiation therapy.~   "
241920|NCT00388011|"~     Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray~     (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo~     in patients with moderate to severe post-surgical pain following orthopedic surgery. After~     initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24)~     hours will be evaluated. The rescue dose remained the same for each.~   "
241921|NCT00387998|"~     RATIONALE: Understanding the risk of disease and prevention and screening activities to lower~     disease risk may help individuals make informed medical decisions.~      PURPOSE: This randomized clinical trial is studying how well health education materials help~     participants understand medical information.~   "
241922|NCT00387985|"~     Primary: To determine the bioequivalence between the new formulation and the current~     formulation of the investigational drug, MOA-728.~   "
241923|NCT00387972|"~     GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral~     therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability~     of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2~     diabetes mellitus.~   "
241924|NCT00387959|"~     RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine,~     total-body irradiation, and rituximab before a donor umbilical cord blood stem cell~     transplant helps stop the growth of cancer cells. It also stops the patient's immune system~     from rejecting the donor's stem cells. The donated stem cells may replace the patient's~     immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).~     Sometimes the transplanted cells from a donor can also make an immune response against the~     body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may~     stop this from happening.~      PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy~     together with rituximab and an umbilical cord blood transplant works in treating patients~     with B-cell non-Hodgkin's lymphoma.~   "
241925|NCT00387946|"~     The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking~     cessation in cigarette smokers. The main secondary objectives are to assess the: craving for~     cigarettes, nicotine withdrawal symptoms, and safety of dianicline.~   "
241926|NCT00387933|"~     RATIONALE: Imatinib mesylate, vatalanib, and hydroxyurea may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Vatalanib may also stop the growth of~     tumor cells by blocking blood flow to the tumor. Giving imatinib mesylate and vatalanib~     together with hydroxyurea may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate~     and vatalanib when given together with hydroxyurea in treating patients with recurrent or~     relapsed malignant glioma.~   "
241927|NCT00387920|"~     This phase I trial is studying the side effects and best dose of sunitinib in treating young~     patients with refractory solid tumors. Sunitinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.~   "
241928|NCT00387907|"~     The purpose of this study is to evaluate the anti-tumor activity of the combination of~     experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast~     cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or~     MRI scans. Additional goals of this study are to look at patient safety, to determine how~     long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects~     the study medications may have on each other, and to find out how long patients remain cancer~     free on this study treatment.~   "
241929|NCT00387894|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with~     recurrent glioblastoma multiforme or gliosarcoma.~   "
241930|NCT00387881|"~     This study was designed to determine the efficacy and tolerability of TREXIMET (formerly~     known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a~     sub-type of migraine.~   "
241931|NCT00387868|"~     This is a phase II study for patients with thymoma or thymic carcinoma thought to be at~     significant risk for recurrence following surgical removal. This study involves the use of~     combined chemotherapy and radiation therapy prior to surgery, in hopes of increasing the~     chances of complete resection. The chemoradiotherapy protocol is one which has been used~     extensively for other diseases, and the side effects are therefore well-documented. Patients~     with thymomas thought to be at significant risk for recurrence (by x-ray and pathology~     criteria) will be allowed to participate, and will undergo combined chemotherapy with~     radiation to the chest followed by surgical removal of the tumor and postoperative~     chemotherapy. The main outcome measured will be the rate of pathological complete response~     (e.g. no active tumor in the resected specimen) to the preoperative treatment. Patients will~     receive postoperative treatment based on surgical and pathologic criteria.~   "
241932|NCT00387855|"~     The purpose of this study was to investigate the impact of the SOS suicide prevention program~     on help-seeking, attitudes toward depression and suicide, and suicidal behavior among high~     school students. Current research protocol has extended this evaluation to the Middle School~     version of SOS.~   "
241933|NCT00387842|"~     COLOR trial is a randomized, international, multi center study comparing the outcomes of~     laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and~     operative data will be collected centrally in the coordinating centre in Rotterdam, The~     Netherlands. Quality of life and costs will be assessed on a national basis.~   "
241934|NCT00387829|"~     To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an~     adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and~     radicular pain in comparison to a control group receiving standard care.~   "
241935|NCT00387803|"~     The purpose of this study was to determine if cardiac resynchronization therapy when combined~     with defibrillation is safe and effective in the treatment of symptomatic heart failure.~   "
241936|NCT00387790|"~     This phase II trial is studying how well giving motexafin gadolinium together with radiation~     therapy works in treating young patients with pontine glioma. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor~     cells more sensitive to radiation therapy. Giving motexafin gadolinium together with~     radiation therapy may kill more tumor cells.~   "
241937|NCT00387777|"~     The purpose of this study is to determine whether Transtec(R) PRO 70 µg/h and a new~     buprenorphine patch formulation lead to same plasma levels of buprenorphine after multiple~     dose application.~   "
241938|NCT00387764|"~     This is an open-label, international, multi-center study designed to provide access to~     pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study~     (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once~     daily. The study treatment will continue until subjects experience disease progression,~     unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is~     to evaluate the safety and tolerability of pazopanib for the treatment of renal cell~     carcinoma. The secondary objectives of the study are to assess response rate (defined as~     complete response or partial response), progression-free survival, and overall survival.~     Response rates will be collected per investigator assessment (no central review). Subjects~     will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.~   "
241939|NCT00387751|"~     This phase II trial is studying how well giving bevacizumab together with sorafenib works in~     treating patients with unresectable stage III or stage IV malignant melanoma. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop~     the growth of melanoma by blocking blood flow to the tumor. Giving bevacizumab together with~     sorafenib may kill more tumor cells.~   "
241940|NCT00387738|"~     The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe~     and effective in reducing the symptoms of ragweed allergy.~   "
241941|NCT00387725|"~     Study to evaluate the safety of an investigational meningitis vaccine and the immune response~     to it in adolescents~   "
241942|NCT00387712|"~     The purpose of this study is to first define whether abnormalities of skeletal muscle are~     related to the presence of inflammation and to poor motor performance and whether this can be~     modified by exercise interventions.~   "
241943|NCT00387699|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some find tumor cells and help kill them or carry tumor-killing substances to them.~     Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also~     stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with cisplatin,~     etoposide, and radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with cisplatin,~     etoposide, and radiation therapy works in treating patients with limited-stage small cell~     lung cancer.~   "
241945|NCT00387673|"~     Electrical stimulation (pulses of electricity applied over the skin of your wrist) and~     activity-based hand exercise have been shown to improve motor skill and strength in~     individuals with stroke and have recently been shown to also have an effect on individuals~     with spinal cord injury. Therefore, the purpose of this research study is to investigate~     whether electrical stimulation alone or electrical stimulation followed by activity-based~     training produces gains in pinch strength (how hard you can squeeze your thumb and pointer~     finger together) and upper extremity function (how well your arm and hand can perform~     activities) in individuals with spinal cord injury.~   "
241946|NCT00387660|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin~     works in treating patients with metastatic or recurrent small cell lung cancer.~   "
241947|NCT00387647|"~     The purpose of this study is to find out if patients older than 60, with acute myeloid~     leukemia, who are in complete remission following initial chemotherapy, will live longer and~     have a lower rate of leukemia relapse when treated with azacitidine.~   "
241948|NCT00387634|"~     evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5~     years after first TBE booster~   "
241949|NCT00387621|"~     In congestive heart failure, cardiac output is low, blood pressure is high, and the body~     becomes congested with fluid. In normal people, when there is high blood pressure, the heart~     muscle cells secrete a hormone that excretes sodium and water in the urine, reducing blood~     pressure. The action of this hormone is called the natriuretic response. The purpose of this~     study is to determine if nesiritide can improve an impaired natriuretic response in subjects~     with asymptomatic systolic heart failure or asymptomatic diastolic heart failure.~   "
241950|NCT00387608|"~     RATIONALE: ABT-888 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth. Collecting and storing samples of blood from patients with cancer to study~     in the laboratory may help doctors learn more about the ways a patient's body handles the~     drug.~      PURPOSE: This early phase I trial is studying the side effects and best dose of ABT-888 in~     patients with refractory solid tumors or hematologic cancer.~   "
241951|NCT00387595|"~     Family history of early atherosclerotic disease in a first-degree relative [(FDR) sibling,~     parent or child] is an important risk factor for coronary artery and/or vascular disease. The~     risk increases ~ 2 - 7 times over that of general population. Increased thickness of the~     intima and media of carotid arterial wall, increased rate of plaque formation is an~     independent predictor of cardiovascular disease. Also it is shown that increased level of~     calcium deposition in the arterial wall is also associated with increased level of coronary~     artery narrowing. We will assess the occurrence and severity of abnormalities of intima media~     thickness (IMT) and/or plaque formation and increased calcium deposition in the coronary~     arteries and their relation to the well known traditional risk factors (plasma glucose,~     smoking, BMI, waist circumference, blood pressure, total cholesterol, low density~     lipoprotein, total cholesterol/high density lipoprotein ratio) and non-traditional risk~     factors (C-reactive protein, Lpa, homocysteine) in FDRs of index patients with early onset of~     heart or vascular disease and appropriate control population. Also to determine which of the~     above factor can assess IMT and Ca score better. This may help to reduce the cost of~     investigation, and to identify the population at high risk of developing cardiovascular~     disease, which may help the physicians to treat early on before cardiovascular complications~     occur. Also this may help to reduce the cost of invasive tests, hospital admissions and~     medical costs overall by reducing the morbidity and mortality.~   "
241952|NCT00387582|"~     This study will evaluate the clinical efficacy of intra-vitreal injections of Ranibizumab~     (Lucentis) in the treatment of Diabetic Macular Edema as compared to grid/focal laser.~   "
241953|NCT00387569|"~     A study to assess the safety of an investigational meningitis vaccine in toddlers and their~     immune response to it.~   "
241954|NCT00387556|"~     Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting~     associated with ketamine during procedural sedation in the pediatric emergency department.~   "
241955|NCT00387543|"~     Discussion and evaluation of patients with sore and burning mouth to determine whether alpha~     lipoic acid is helpful in managing their symptoms.~   "
241956|NCT00387530|"~     RATIONALE: The Epstein-Barr virus can cause cancer and lymphoproliferative disorders.~     Valganciclovir is an antiviral drug that acts against the Epstein-Barr virus. Phenylbutyrate~     may make cells infected with Epstein-Barr virus more sensitive to valganciclovir. Giving~     phenylbutyrate together with valganciclovir may block the growth of Epstein-Barr~     virus-infected cells and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving phenylbutyrate together with~     valganciclovir works in treating patients with relapsed or refractory Epstein-Barr~     virus-positive cancer.~   "
241957|NCT00387517|"~     The purpose of this trial is to evaluate the safety and efficacy of combination therapy of~     aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in~     patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.~   "
241958|NCT00387504|"~     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide in~     treating patients with metastatic or unresectable malignant solid tumors.~   "
241959|NCT00387491|"~     To assess the effect of a single oral dose of MOA-728, an investigational drug, on the~     oral-cecal transit time in subjects who are taking methadone.~   "
241960|NCT00387478|"~     Tree MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients~     with hypersensitivity to Tree (birch, alder, hazel) pollen (hay fever). This novel~     formulation is designed to provide a vaccine that will be efficacious with only four~     escalating dose injections administered before the start of the pollen season. In this Study~     the Efficacy will be assessed by exposing allergic subjects to birch pollen in an~     environmental exposure chamber EEC. Patient symptomatic response to birch pollen and patient~     quality of life in the EEC will be determined.~   "
241961|NCT00387465|"~     This phase I/II trial is studying the side effects and best dose of azacitidine when given~     together with entinostat and to see how well they work in treating patients with recurrent~     advanced non-small cell lung cancer. Azacitidine and entinostat may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together~     with entinostat may kill more tumor cells.~   "
241962|NCT00387452|"~     Older persons with diabetes have a harder time maintaining blood pressure when standing up.~     When blood pressure drops when standing up, fainting may occur. This study will see how~     regular exercise can improve the ability of the body to keep blood pressure up when standing.~     We want to see how this improvement varies with different types of exercise. The types of~     exercise that we will be studying are aerobic (running or cycling on a stationary bike) and~     strength training (weight lifting).~   "
241963|NCT00387439|"~     The purpose of this study is to evaluate the impact of anoperineal physiotherapy in~     adjunction to standard medical treatment on symptoms and quality of life of adults with anal~     incontinence, in comparison with standard treatment alone.~      A total of 443 patients will be randomized to 2 groups: standard care (medical treatment)~     alone or standard care associated with anoperineal physiotherapy. Outcome measures include~     the patient own view of the effectiveness of the treatment, the continence score, quality of~     life and psychological status. These outcomes are measured at the end of the 4 months~     treatment period.~      Following this period, the non responders to standard medical treatment will be proposed to~     undergo a course of anoperineal physiotherapy and the non responders to anoperineal~     physiotherapy will be treated by transcutaneous electrical nerve stimulation (TENS). The~     outcomes will be measured at the end of the 4 months new treatment and again after 4 months~     follow-up.~   "
241964|NCT00387426|"~     This phase II trial is studying how well sunitinib works in treating patients with idiopathic~     myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the abnormal cells.~   "
241965|NCT00387413|"~     GSK189254 is a highly potent histamine 3 (H3) receptor antagonist which has demonstrated~     efficacy in the reduction of mechanical hyperalgesia and allodynia in the chronic~     constriction injury pre-clinical model of neuropathic pain (NP). The mechanism of action of~     GSK 189254 in the pain model is hypothesised to be via enhanced release of monoamines in the~     central nervous system (CNS). A similar mechanism of action has also been shown for~     duloxetine. In this phase I study, the safety and efficacy of GSK189254 will be investigated~     in the electrical hyperalgesia (EH) model in healthy volunteers to build confidence that the~     preclinical efficacy demonstrated by this compound will translate into patients.~      This study will be conducted as a double-blind, double-dummy, placebo-controlled, incomplete~     block, two period crossover study. Up to 40 healthy male or female volunteers, aged 18-45~     years old, will be randomised into the study in order to achieve 32 evaluable subjects.~     Subjects will undergo two 3-week treatment periods and will be randomised to receive placebo~     and either GSK189254 (up to 100µg once daily) or duloxetine (up to 60mg daily). There will be~     a one week washout between treatment periods. The effects of repeated oral dosing of~     GSK189254 and duloxetine on secondary hyperalgesia in the EH model will be determined.~     Subject: GSK189254, Neuropathic pain (NP), H3 antagonist, duloxetine, Electrical~     hyperalgesia, Phase I, Healthy volunteers, Double blind, Safety, tolerability.~   "
241966|NCT00387400|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. Giving temozolomide together with everolimus~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with temozolomide in treating patients with newly diagnosed, recurrent, or~     progressive malignant glioblastoma multiforme.~   "
241967|NCT00387387|"~     This study will test the safety of treating colorectal cancer with a combination of drugs.~     The current standard treatments of FOLFOX6 or CapeOx will be give in combination with the GSK~     investigational drug pazopanib.~   "
241968|NCT00387374|"~     This phase II trial is studying the side effects and how well giving radiation therapy~     together with bevacizumab, paclitaxel, and carboplatin works in treating patients with~     unresectable stage IIIB or stage IV non-small cell lung cancer at high risk for hemoptysis~     caused by bevacizumab. Radiation therapy uses high-energy x-rays to kill tumor cells. It may~     also prevent hemoptysis caused by bevacizumab. Monoclonal antibodies, such as bevacizumab,~     can block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to~     the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving radiation therapy together with bevacizumab and chemotherapy may kill more~     tumor cells~   "
241969|NCT00387361|"~     The purpose of this study is to determine if Osteopathic Manipulative Treatment (OMT) is~     effective in reducing nausea and vomiting experienced by patients recovering from anesthesia.~     OMT is a treatment in which the physician places his hands on areas of the body and applies~     pressure to correct disturbances in one area that may be related to a problem in another area~     of the body. Osteopathic Manipulative Medicine is a specialty for a physician who uses OMT.~      The hypothesis of this study is when OMT is combined with standard-of-care prophylactic~     anti-emetic therapy in patients following administration of inhalational anesthesia, in~     comparison to a control group receiving only standard-of-care anti-emetic prophylaxis there~     will be a reduction in the incidence and severity of PONV.~   "
241970|NCT00387348|"~     RATIONALE: Escitalopram may help improve depression and quality of life in patients with~     advanced lung or gastrointestinal cancer. It is not yet known whether escitalopram is more~     effective than a placebo in treating depression in patients with advanced lung or~     gastrointestinal cancer.~      PURPOSE: This randomized clinical trial is studying the side effects of escitalopram and to~     see how well it works compared to a placebo in treating depression in patients with advanced~     lung or gastrointestinal cancer.~   "
242021|NCT00386672|"~     The purpose of the study is to find out if taking calcium and vitamin D supplements, while~     following a low-calorie diet, can help people lose weight.~   "
241971|NCT00387335|"~     This phase II trial is studying how well sunitinib works in treating patients with recurrent~     and/or metastatic head and neck cancer. Sunitinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
241972|NCT00387322|"~     RATIONALE: Pemetrexed disodium and erlotinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving pemetrexed disodium together with~     erlotinib may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of two different~     schedules of pemetrexed disodium and erlotinib and to see how well they work in treating~     patients with advanced non-small cell lung cancer or other solid tumors.~   "
241973|NCT00387309|"~     Primary Objective: In subjects who have undergone segmental colectomy, the time between the~     end of surgery and first bowel movement is significantly shorter with the investigational~     MOA-728 regimen than with a placebo regimen.~   "
241974|NCT00387296|"~     The study's aim is to determine whether use of a mechanical device can improve the timeliness~     of anesthesia provided by liposomal lidocaine cream. Liposomal lidocaine cream has~     historically come in the brandnames of ELA-Max and LMX, with either 4% or 5% lidocaine in the~     cream. In this protocol, the abbreviation LLC will be generally used to refer to the 4%~     concentration to be used in FAST Lidocaine. Regardless of the concentration used, the~     encapsulation of lidocaine in liposomes protects the anesthetic from rapid metabolism and~     allows the medication to remain in the epidermis, yielding a theoretical benefit of~     long-lasting anesthesia.1 The test device is a painless functional microarray (FMA) that~     renders hundreds of microscopic punctures per cm2 in a patient's stratum corneum. The holes~     in the stratum corneum subsequently allow for faster movement of LLC into the skin to be~     anesthetized.~      Currently, topical anesthetics are used less commonly in the Emergency Department (ED) than~     would be the case if the available approaches were not associated with such long onset times.~     The most commonly utilized topical anesthetic for intact skin, eutectic mixture of local~     anesthetics (EMLA), requires at least an hour for anesthetic effect; maximal effect requires~     up to 2 hours.2, 3 4 The topical anesthetic to be used in the FAST Lidocaine study, 4% LLC,~     has a roughly equipotent analgesic effect to that of EMLA and works faster, but must still be~     in place for at least a half-hour before onset of reliable anesthesia.1, 5-8 Commentators~     have judged such delays considerable and written that because of long application times,~     use of topical anesthetics may not be practical.1, 8-10 In discussing agents (such as LLC)~     that are formulated for more rapid transcutaneous absorption, ED wound care experts have~     written that their delayed onset limits their use in the emergent setting.11 It has also~     been noted that LLC's utility is potentially diminished by the fact that anesthesia may begin~     to wear off as soon as 10 minutes after cream removal.8 Given the previously outlined~     findings, it is obvious that there is room for improvement in ED delivery of topical~     anesthesia. The goal of rendering topical anesthesia practical - and thus more likely to be~     used - constitutes the basis for the FAST Lidocaine study. We seek to identify whether a~     novel approach safely and painlessly improves the onset time (and perhaps depth) of topical~     anesthesia.~      Reducing pain caused by procedures involving violation of the skin barrier (e.g. intravenous~     [IV] line placement, anesthesia and suturing of wounds) is an important goal. Needlesticks~     and IV catheters have been identified as important causes of pain in both children and~     adults.8, 12, 13 In terms of frequency, U.S. EDs place over 20 million IV catheters and care~     for over 10 million wounds.9 Thus, there is potentially broad-based utility in a potentiator~     for local anesthesia absorption in the ED.~      The importance of the clinical goal of improving absorption of topical anesthesia has already~     prompted efforts aimed at improving delivery and efficacy of topically applied local~     anesthetics. Previous investigations have demonstrated utility - and limitations - of various~     methods of traversing and/or stripping the stratum corneum. Among the techniques studied have~     been use of electrical energy (iontophoresis),14 sound waves (sonophoresis),15, 16 adhesive~     tape17-19 and lasers.11, 12, 20, 21 While these varying approaches all have promise, their~     limitations leave room for assessment of a new method if it promises to be safe, painless,~     and effective.~      The approach of the FAST Lidocaine study will be to assess FMA use. The FMA is a painless~     mechanism that is placed on the skin with minimal pressure. It creates microscopic punctures~     in the stratum corneum, facilitating movement of anesthetic through the cutaneous barrier.~     The device's physical characteristics, namely its easy application and low apparent potential~     for incorrect or unsafe use, appear quite suitable for ED utilization. If it works, the FMA~     would be immediately useful in a variety of circumstances.~      The overarching goal of the FAST Lidocaine investigators is to assess whether the FMA can~     improve management of procedure-related pain in the ED. The main problem in terms of ED use~     of the currently available topical anesthetics - whether EMLA, LMX, or others - is the time~     of onset, rather than anesthetic efficacy. Thus, it is the timing impracticality for most ED~     situations that is the spur for FAST Lidocaine. The study's primary focus and endpoint will~     be time to anesthesia. Secondary analysis will evaluate whether the depth of anesthesia is~     improved by assessing the nadir of visual analog scale (VAS) assessments. However, it is~     noteworthy that deeper anesthesia is not necessary in order to establish the potential~     utility of FMA in the acute care setting.~   "
241975|NCT00387283|"~     During a clinical study of people with severe West Nile virus infections, it was determined~     that the drug AVI-4020 crossed the blood-brain barrier. This study will assess the amount of~     drug that goes across the blood-brain barrier and the drug levels measured in both the blood~     and urine.~      The objective of this study is to find out how much and how fast this drug crosses this~     barrier.~   "
241976|NCT00387270|"~     This study is being conducted to determine the safety and tolerability of Dimebon in people~     with Huntington's disease after short-term exposure (one week) and after longer exposure~     (three months). Also, the study will assess whether or not there is an effect of Dimebon on~     the symptoms of Huntington's disease, including cognitive (thinking abilities), motor~     (movement), behavior, and overall functioning.~   "
241977|NCT00387257|"~     The purpose of this study is to compare the effects of repeat doses of SB-659032 with placebo~     on platelet aggregation in subjects.~   "
241978|NCT00387244|"~     The primary objective of this study is to evaluate the efficacy of spinal cord stimulation~     using the Precision implantable neurostimulation device for chronic and intractable pain of~     the trunk and or limbs in patients who have failed treatment with an intraspinal infusion~     pump or other SCS system.~   "
241979|NCT00387231|"~     Silent ischemia has been shown to negatively affect prognosis in patients after myocardial~     infarction. However, long-term outcome data in totally asymptomatic patients is missing and~     it is unknown whether angioplasty in addition to secondary preventive measures is superior to~     antiischemic drug therapy in these patients. Therefore, the SWISSI 2 study was started 15~     years ago with the aim of comparing the effects of angioplasty with medical therapy on~     long-term outcome in patients with recent myocardial infarction and silent ischemia.~   "
241980|NCT00387218|"~     This study is designed to compare three different exercise approaches to learn which program~     is best for people with early and mid-stage Parkinson's disease. Results from this study will~     help determine if participants can maintain the benefits from exercise and will help~     determine which program people with Parkinson's disease are more likely to continue using.~   "
241981|NCT00387205|"~     This study is a rollover study to evaluate the long term safety of pazopanib and to continue~     to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until~     pazopanib is available commercially.~   "
241982|NCT00387192|"~     The main objective of the study is to assess the pharmacokinetics of OPTIVATE® after a single~     dose of 80 IU/kg VWF:RCo. The secondary objectives of the study are to assess efficacy and~     safety of OPTIVATE® in long-term use over at least 12 months.~   "
241983|NCT00387179|"~     Jet lag and some sleep disorders are caused by a disruption in an individual's internal~     clock. Understanding the most effective way to quickly re-adjust the body's internal clock~     will be beneficial for treating individuals with these conditions. This study will evaluate~     the combined effectiveness of light and non-light therapies at regulating sleep cycles and~     improving sleep quality.~   "
241984|NCT00387166|"~     Cardiovascular disease (CVD) is the leading cause of death in American women, claiming on~     average 40% of all female deaths each year. Although the number of CVD-related deaths in the~     United States has decreased over the last several decades, the rate of decline has been less~     for women than for men. Specifically, minority women of low socioeconomic status make up a~     disproportionately high number of CVD cases and related deaths. Previous studies suggest~     that, in addition to many other variables, psychosocial variables may contribute to ethnic~     CVD disparities. More research, however, is needed to help understand and reduce these~     differences. This study will examine the associations among socioeconomic status,~     psychological and social factors, CVD biomarkers, and CVD in Mexican-American women.~   "
241985|NCT00387153|"~     Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.~   "
241986|NCT00387140|"~     This study is being conducted to evaluate the safety and tolerability of the drug and to~     evaluate its efficacy compared to placebo and to ibuprofen in the treatment of postoperative~     dental pain in male patients.~   "
241987|NCT00387127|"~     This is a phase II study comparing the effects of lapatinib versus placebo when administered~     concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or~     placebo. The study is designed to evaluate and compare the two treatment groups with respect~     to complete response rate at 6 months following chemoradiation completion.~   "
241988|NCT00387114|"~     The aim of the present study was to evaluate whether an in vivo treatment with an antioxidant~     vitamin (vitamin C) might substantially affect serum levels of resistin, a recently described~     adipokine, whose clinical significance is still controversial in humans.~   "
241989|NCT00387101|"~     The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard~     of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment~     to SOC alone.~   "
241990|NCT00387088|"~     The objective of the study is to evaluate the long-term (one year) efficacy and safety of~     tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study~     will examine the effect of treatment on COPD exacerbations.~   "
242022|NCT00386659|"~     Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological~     response in plasma and extra-plasmatic compartments, together with the degree and kinetics of~     immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when~     treated with tenofovir and abacavir together with lopinavir or efavirenz.~   "
241991|NCT00387075|"~     This study is designed as a prospective cohort study to test the strategy of combining two~     biomarkers of parkinsonism, olfaction and brain imaging with a radioactively labeled drug,~     [123I]β-CIT , in a population of first-degree relatives of PD patients as a tool to establish~     an 'at risk' Parkinson disease cohort without motor symptoms of PD. First-degree relatives of~     PD will be recruited through PD research sites and national foundations to participate in~     this study. In addition, first degree relatives of PD patients will be recruited directly~     through advertising.~   "
241992|NCT00387062|"~     The investigators hypothesize that continuous active interaction with environments that are~     demanding to sensory, cognitive, and motor systems, together with imbedded rewards for~     successful performance, will help improve memory and cognitive functioning in patients~     suffering from chemobrain.~   "
241993|NCT00387049|"~     The purpose of this study is to develop and test a smoking cessation intervention for persons~     who are specifically sensitive to anxiety and anxiety-related bodily sensations.~   "
241994|NCT00387036|"~     To test the effect of the research study drug, inhaled fluticasone on lung function in~     exercising patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
241995|NCT00387023|"~     Primary Objectives:~        1. To evaluate the efficacy of Zevalin for the treatment of low-grade follicular~          Non-Hodgkin's lymphoma of the orbit or mucosa-associated lymphoid tissue (MALT) of~          conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy~          and external examination of the conjunctiva), and external photography whenever~          possible.~        2. To establish the safety profile in this patient population using clinical examination~          including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.~        3. To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to~          undergo dosimetry.~   "
241996|NCT00387010|"~     The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal~     tablets on the anxiety symptoms commonly associated with chronic pain in patients with~     breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate~     patient functioning, and to determine any influences on the successful dose achieved.~   "
241997|NCT00386997|"~     Due to the poor outcome of patients with invasive fungal infections (IFI), a more effective~     prevention of these infections in such patients is wanted. These experiences in intensively~     treated elderly patients with acute leukemia are especially worrying.~      This pilot study is designed to collect information on the safety (and efficacy) of an~     antifungal preventative therapy with an AmBisome® loading dose regimen of 7 mg/kg/week, in~     four weekly administrations, during the aplastic phase following the start of chemotherapy~     for acute lymphoblastic leukemia in elderly patients, which is a high risk period for severe~     fungal infections.~   "
241998|NCT00386984|"~     A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can~     prolong survival time in patients with primary liver cancer. Due to methodological~     deficiencies of the preliminary study the results will be re-checked by the comparison of~     octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time~     and secondarily concerning costs, side effects, patient cooperation and quality of life as~     well as specific conditions in the tumor tissue in both groups with 108 patients with primary~     liver cancer.~   "
241999|NCT00386971|"~     Included in this study will be patients with HIV and being treated with highly active~     antiretroviral medications (HAART) including protease inhibitors (PI) or non-nucleoside~     reverse transcriptase inhibitors (NNRTI). Protease inhibitors and non-nucleoside reverse~     transcriptase inhibitors are very common medications in HIV treatment and are usually given~     with other medications as part of a standard treatment for HIV (HAART).~      We hope to learn more about how the levels of cholesterol-and triglyceride-carrying particles~     (lipoproteins) are affected by a nutritional supplement, L-Carnitine, in HIV-positive~     patients treated with antiretroviral medications.~   "
242000|NCT00386958|"~     Bacterial corneal ulcers are a leading cause of pediatric blindness in underdeveloped~     countries due to a lack of antibiotic availability and affordability, among other reasons.~     Povidone-iodine, an inexpensive and readily available broad-spectrum antimicrobial agent, may~     be an effective and affordable treatment for corneal ulcers, allowing preservation of sight~     for those afflicted with this disease.~   "
242001|NCT00386945|"~     The purpose of the study is to develop an office-based tobacco intervention for chiropractic~     patients.~   "
242002|NCT00386919|"~     Patients with high grade brain tumors will be treated to test shortened course of radiation~     therapy with the use of precise, focused radiation with cyberknife.~   "
242003|NCT00386906|"~     The goal of this clinical research study is to find the sentinel lymph node (SLN) (s) and~     biopsy it (them) to see if the patient has small or low volume metastatic disease that would~     otherwise have been missed.~   "
242004|NCT00386893|"~     Aim of this study is to investigate neuronal differences (EEG/evoked potentials; functional~     MRI) between patients with major depression and healthy controls concerning brain activity~     after acute pain as well as changes of pain related brain activity during treatment with~     escitalopram.~   "
242005|NCT00386880|"~     Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has~     been noted in several studies that in patients with migraine, seventy nine percent of the~     patients experienced allodynia on the facial skin on the same side as the headache.~     Understanding more about the occurrence of phonophobia (increased sensitivity to sound) and~     allodynia may help us understand how the pain system works in migraine. It is hoped that the~     knowledge gained from this trial may enable us to more effectively treat patients with~     migraine headache.~   "
242006|NCT00386867|"~     This open-label, randomized study will compare the efficacy, safety, and acceptability of~     mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral~     misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.~   "
242007|NCT00386854|"~     The purpose of this study is to evaluate the metabolic and anti-inflammatory effects of~     eccentric endurance exercise and to compare them with those of concentric exercise in healthy~     sedentary individuals.~   "
242008|NCT00386841|"~     The purpose of this study is to determine whether outcome following antidepressant treatment~     can be used as a tool to evaluate endo-phenotypes for depression.~   "
242009|NCT00386828|"~     This phase II study will evaluate the effect of bevacizumab, capecitabine and oxaliplatin~     with radiation on rectal cancer. Researchers will also evaluate the tolerability (how it~     makes the patient feel) and safety of this combination by watching for harmful~     side-effects.It is hoped that by adding bevacizumab to the capecitabine/oxaliplatin treatment~     in combination with radiation before surgery will improve response rate.~   "
242010|NCT00386815|"~     To investigate safety of pemetrexed combined with cisplatin for chemo therapy-naive patients~     with malignant pleural mesothelioma~   "
242011|NCT00386802|"~     Primary purpose: Frequency of use of broad-spectrum antifungals in the episode of~     neutropenia.~      Secondary purposes:To determine the safety and toxicity measure by:~        1. Frequency of Invader Fungal Infection.~        2. Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole,~          voriconazole, caspofungin, terbinafine, during the period of study.~        3. Mortality~        4. Development of nephrotoxicity~        5. Use of galactomannan in this clinical context~        6. Time of administration of empirical antifungal therapy of broad-spectrum.~   "
242012|NCT00386789|"~     Typhoid fever remains an important cause of morbidity and mortality in the developing world.~     It is estimated that more than 16 million cases and about 600,000 deaths occur annually, most~     of which occur in Southeast Asia and Africa. Ingestion of food or water contaminated by~     acutely infected persons or chronic carriers is the most common form of transmission. As a~     result, typhoid fever is prevalent where unsafe drinking water or contaminated food is~     common.~      Typhoid fever is highly endemic in Vietnam, especially in the southern provinces and is a~     significant disease in both preschool and school-aged children. Data from Dong Thap~     Provincial Hospital, Mekong delta region showed that among 3,934 hospitalized typhoid fever~     cases from 1990 to 1995, 4.2% had complications and 0.8% died.~      Typhoid fever has become difficult and expensive to treat. About 90% of Salmonella typhi~     isolates are of multidrug-resistant (resistant to chloramphenicol, ampicillin, and~     trimethoprim-sulfamethoxazole) and 76% of isolates showed reduced susceptibility to~     fluoroquinolones. Isolates with full fluoroquinolone or extended spectrum cephalosporin~     resistance have not yet reported in Vietnam but occur sporadically in the Indian~     subcontinent. If they become widespread, alternative treatment options will be limited. The~     improvement of sanitation, provision of safe water and elimination of chronic carriage is not~     expected to be achieved quickly. Accordingly, vaccination against typhoid fever is~     increasingly important national public health priority.~   "
242013|NCT00386776|"~     With this clinical study, we hoped to find out if interactive, computer-based medical~     interviews, when carefully tested and honed and made available to patients in their homes on~     the Internet, will improve both the efficiency and quality of medical care and be well~     received and found helpful by patients and their physicians. We developed the computer-based~     medical interview consisting of over 6000 questions and a corresponding program that provides~     a concisely written, summary of the patient's responses to the questions in the interview. We~     then conducted read aloud and test/retest reliability evaluations of the interview and~     summary programs and determined the programs to be reliable. Results were published in the~     November 27, 2010 issue of the Journal of the American medical Informatics Association. We~     also developed, edited, and revised a program that provides a concisely written, summary of~     the patient's responses to the questions in the interview.~      We obtained a grant from the Rx Foundation to conduct clinical trial of our medical history.~     At the time of the office visit, the summary of the computer-based history of those patients~     who had completed the interview was available on the doctor's computer screen for the doctor~     and patient to use together on a voluntary basis. The results of this trial were published in~     the January 2012 issue of the Journal of the American Informatics Association.~   "
242014|NCT00386763|"~     This study will evaluate the safety and efficacy of artemether-lumefantrine against~     uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.~   "
242015|NCT00386750|"~     THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.~      To evaluate the effects of artemether/ lumefantrine on the auditory function.~   "
242016|NCT00386737|"~     Annually, asthma is responsible for 1 million emergency room visits, 400,000~     hospitalizations, and 5000 deaths according to the NHLBI. In addition, 10 million missed~     school-days per year and 100 million days of restricted activity are attributed to this~     disease. While there is no known cause or cure for asthma, recent studies have shown that~     hospitalizations and emergency room visits can be reduced by as much as 78% and 73%,~     respectively, when the disease is properly managed. According to the EPA, the occurance of~     children with asthma more than doubled the rate of two decades ago; in 2001 the percentage of~     asthmatic children was 8.7% (6.3 million children).~      Properly managing asthma is nontrivial and can often require an asthma specialist. The~     difficulty in diagnosing and managing asthma lies primarily in the lack of available clinical~     technologies capable of assessing airway inflammation, an early and persistent component of~     asthma. Accordingly, the National Institutes of Health (NIH) guidelines for the diagnosis and~     management of asthma strongly recommend long term anti-inflammatory therapies, such as oral~     or inhaled corticosteroids, to reverse airway inflammation in an effort to prevent~     irreversible airway damage, termed “airway remodeling”. The medical community has expressed~     the need for more objective and noninvasive measures of airway inflammation for diagnosing~     asthma and monitoring the effectiveness and compliance of anti-inflammatory therapies.~      The clinical research plan is designed to evaluate airway inflammation associated with~     asthma. In this human subjects study, a non-invasive exhaled breath analysis sensor, called~     the Breathmeter, will be used to measure eNO concentrations in children and adults (ages~     4-65) with a broad range of respiratory disorders as well as those with no known respiratory~     disorders. Breath donations will be simple and straightforward presenting little to no~     discomfort to volunteers.~   "
242017|NCT00386724|"~     The primary objective of this study is to evaluate the acute and chronic efficacy of spinal~     cord stimulation using the Precision implantable neurostimulation device with the Artisan~     paddle electrode in patients with Failed Back Surgery Syndrome (FBSS) and associated primary~     or secondary back or lower extremity pain. There are significant numbers of patients with~     FBSS who have moderate to severe drug refractory pain. An optimal outcome will demonstrate~     that the Precision SCS device has significant effectiveness in reducing this pain resulting~     in improved quality of life and functional capacity.~   "
242018|NCT00386711|"~     improve detection and management of suicide risk among depressed patients in primary care~   "
242019|NCT00386698|"~     Since influenza vaccines are normally administered every year because of the frequent change~     in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted~     influenza vaccine need to be re-evaluated after repeated vaccine administration. In this~     study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007~     season's formulations of Fluarix or the adjuvanted vaccine.~   "
242020|NCT00386685|"~     The primary objective of the study is to assess the activity of XRP9881 in combination with~     trastuzumab.~      The secondary objectives are safety and pharmacokinetic interaction~   "
242024|NCT00386633|"~     At the end of 2004 there were more than 40 million people infected worldwide with HIV, with~     an estimated 16,000 new infections every day (Joint United Nations Programme on HIV/AIDS~     [UNAIDS], 2004). The HIV epidemic threatens whole societies particularly in Africa and Asia~     and rates of infections in the Western countries have also increased over the last few years.~     However, despite more than 15 years of research, an effective vaccine against HIV and~     acquired immunodeficiency syndrome (AIDS) has still not been developed.~      There is considerable evidence that cellular immune responses can effectively control HIV-1~     replication during acute and chronic infections thereby possibly protecting individuals from~     infection and preventing the spread of HIV. To be truly effective in the general population,~     a vaccine must induce responses specific to immunologically conserved regions. The~     epitope-based vaccine MVA-mBN32 represents a very logical approach to this problem because of~     its potential to elicit a polyfunctional immune response and to focus these responses to~     conserved epitopes.~      In this study the safety, tolerability, and immunogenicity of a recombinant MVA-BN® vaccine~     expressing cytotoxic T lymphocyte (CTL) and helper T lymphocyte (HTL) epitopes of HIV-1~     (MVA-mBN32) in 36 healthy volunteers will be examined. This will include a full analysis of~     CD4+ T helper cells and CD8+ CTL responses to these epitopes, to establish the potential of~     such a homologous prime-boost vaccine approach to induce a broad cell-mediated response to~     different HIV antigens.~   "
242025|NCT00386620|"~     Ecological Momentary Assessment (EMA) refers to the collection of repeated measurements of~     phenomena as they occur in naturalistic settings using hand-held computers. By providing an~     EMA of psychosocial variables that influence patient pain and pain behaviors, this study~     seeks to characterize the pain experience in metastatic breast cancer from both patients' and~     spouses' perspectives.~      This study consists of two parts. Part 1 involves developing and pilot testing a hand-held~     computer program designed to assess antecedents, behaviors, and consequences of patient pain,~     as well as spouse response to pain. Five couples will complete a baseline survey and carry~     the hand-held computer for two weeks. They will be interviewed for feedback to refine the~     program. Part 2 is a longitudinal assessment of the psychological and relationship~     functioning of metastatic breast cancer patients and their spouses. The Optional Procedure~     for Part 2 involves using electronic diaries (EDs) to measure the cancer pain experience for~     patients with metastatic breast cancer and their spouses.~      The specific aims of this study are to: (1) To examine patient pain, spouse response to~     patient pain, and patient behaviors in response to pain over the course of 6 months in~     couples facing metastatic breast cancer, (2) test the biopsychosocial model of chronic pain~     in breast cancer; expanding it to include the influence of patient psychological functioning,~     spouse psychological functioning, and relationship functioning, on patient pain, spouse~     behaviors, and patient behaviors in response to pain, (3) use ecological momentary assessment~     to characterize patient pain, spouse response to patient pain, and patient behaviors in~     response to pain.~   "
242026|NCT00386607|"~     Assessment of the long-term safety and tolerability of the combination of aliskiren and~     valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of~     long-term safety and tolerability of the combination of~     aliskiren/valsartan/Hydrochlorothiazide(HCTZ).~   "
242027|NCT00386594|"~     Barrett's esophagus with high-grade dysplasia is a premalignant condition caused by chronic~     reflux of gastric contents into the esophagus. High-grade dysplasia is the same as~     carcinoma-in-situ. If untreated, patients with this condition are at high risk for developing~     cancer of the esophagus. Cancer of the esophagus is a miserable disease that is difficult to~     treat and about 95% fatal after 5 years. To prevent progession to cancer of the esophagus~     several interventions are available and they include surgery, Photofrin photodynamic therapy,~     endoscopic mucosal resection and endoscopic thermal therapy. All of these modalities are~     uncomfortable, expensive and have associated risks. The oral agent, 852A stimulates the~     innate immune system in such a way as to eliminate early cancer. A similar dermatologic~     drug(imiquimod) is approved for treating the premalignant condition, actinic keratosis. If~     local therapy with imiquimod can eliminate a premalignant lesion in the skin, a similar~     acting drug should be able to do the same for a premalignant lesion in the lining of the~     esophagus. This study is designed to test that hypothesis.~   "
242028|NCT00386581|"~     The study is designed to investigate the acute treatment efficacy, safety, and tolerability~     of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week~     acute treatment period and a 2-week discontinuation phase. The assessments in this study~     include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical~     Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.~   "
242029|NCT00386555|"~     To determine the effectiveness of CP-868,596 + docetaxel, AG-013736 + docetaxel and~     CP-868,596 + AG-013736 + docetaxel in patients previously treated for non-small cell lung~     cancer.~   "
242030|NCT00386542|"~     This is a sequential phase I and II, controlled, double-blinded study to determine whether~     immune responses suggesting protection against influenza can safely be induced in young~     children by two reduced doses one month apart of 0.1 mL of a trivalent inactivated influenza~     vaccine (INF) administered by the intradermal (ID) route with an investigational ID spacer on~     a United States (U.S.)-licensed needle-free jet injector (JI), compared to two standard~     intramuscular (IM) 0.25 mL doses by needle-syringe (N-S) in this age group. The locale is a~     developing country where financial restraints for the use of full-dose influenza vaccine~     would limit protection from an influenza pandemic threat, where N-Ss pose dangers and~     drawbacks in clinical use, and where Mantoux-type N-S ID injections are difficult to~     administer during mass campaigns.~   "
242031|NCT00386529|"~     The purpose of this study is to evaluate the influence of aspirin on blood pressure in~     well-controlled hypertensive patients who receive low dose aspirin at different times of the~     day~   "
242032|NCT00386516|"~     The purpose of this clinical trial is to determine whether the combination of the established~     chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule GM-CT-01 is~     beneficial in treating advanced gall bladder and bile duct cancer.~   "
242033|NCT00386503|"~     -  Primary Objective: to evaluate the interaction with food after a single oral dose of a~          fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male~          subjects~        -  Secondary Objective: to assess the clinical and biological safety and tolerability of~          Coarsucam™~   "
242035|NCT00386477|"~     The objective of the project is to find out whether cleansing the vagina before a cesarean~     delivery decreases the risk of complications and infections after having the baby. If this is~     the case, cleansing the vagina before cesarean delivery can help improve outcomes for many~     women and make their early postpartum recovery much more pleasant, giving a healthier start~     for the family.~   "
242036|NCT00386464|"~     Non-invasive ventilation or BiPAP®, which is a form of breathing support delivered through a~     facemask, is a successful treatment for the respiratory complications of amyotrophic lateral~     sclerosis (ALS). It has been shown to prolong survival, improve quality of life, and improve~     cognitive function. It is widely used among patients with ALS who have advanced breathing~     difficulties. It is not known whether there is benefit to using non-invasive ventilation~     earlier in the disease course.~      There is evidence that non-invasive ventilation may slow down the decline in breathing~     function. If this were true then it would make sense to start non-invasive ventilation use~     earlier than the current clinically accepted practices.~      The purpose of this study is to determine whether using non-invasive ventilation early in the~     course of disease can slow the decline in breathing function.~      Patients remain in the study for 6 months and are asked to make 7 clinic visits during which~     time they will undergo pulmonary function tests and complete questionnaires.~   "
242037|NCT00386451|"~     A prospective randomized study to compare 2 groups:~        -  heparine lock with positive pressure~        -  lock without a needle with positive pressure~   "
242038|NCT00386438|"~     -Does Honan balloon reduce intraocular pressure preoperatively?~   "
242039|NCT00386425|"~     In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin~     alfa (activated) at the normal, approved dose and time of administration [24~     microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose~     or higher doses than the approved dose for a longer administration time. After the drug~     administration is complete, the protein C levels from the patients receiving the normal,~     approved dose will be compared to protein C levels from patients receiving the normal,~     approved dose or higher dose for a longer duration to determine if the protein C levels~     improve faster if given higher dose and/or longer administration time.~      Note: The protocol was amended to remove the option of shorter infusion durations.~   "
242040|NCT00386412|"~     PRINCIPAL ENDPOINT To value valganciclovir efficacy in advance treatment of CMV in patients~     received allogenic transplant with a uniform treatment.~      SECONDARY ENDPOINT To value valganciclovir security in advance treatment of CMV in in~     patients received allogenic transplant with a uniform treatment.~      The security will be valued by the % of patients that:~      Will have negative CMV Neutropenia <1000 neutrophils/mm3 or <500 neutrophils/mm3 in the first~     35 days of treatment - follow-up Renal toxicity in the first 35 days of treatment - follow-up~     (defined by elevated creatinine >1mg/dL or twice the basal value) CMV illness during the~     treatment or in the next 2 months Blood Antigenemia / PCR positive in the next 2months of~     treatment~      This dates Hill be compared with a patients control group treated with intravenous~     valganciclovir~   "
242041|NCT00386399|"~     Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they~     will be treated with Mitomycin-C as described here. The patients with an identified gene~     mutation will also be provided with genetic counseling.~   "
242042|NCT00386386|"~     The study's overarching aim is to determine whether Enzymatically Augmented Subcutaneous~     Infusion (EASI) can assist in out-of-hospital situations characterized by mismatch between~     need for, and ability to achieve, access to the vascular compartment. One mechanism for~     providing access to the vascular compartment, subcutaneous infusion, is facilitated by~     administration of hyaluronidase; the hyaluronidase hydrolyzes hyaluronan the major~     subcutaneous diffusion barrier. Hyaluronidase thus increases local dispersion and absorption~     of subcutaneously administered drugs and fluids.~      The EASI Access study is intended to be the first out-of-hospital study assessing~     FDA-approved Chinese hamster ovary-derived recombinant hyaluronidase (the recombinant product~     is hereafter referred to by the shorter brand name, Hylenex). The EASI Access will test some~     fundamental principles and will facilitate design and implementation of follow-up~     investigations (e.g. extension of access to non-ALS providers). For example, we will attempt~     to show that EASI access is simple, effective, and has few or no downsides as compared to IV~     access.~   "
242043|NCT00386373|"~     Primary Objective:~      1. To assess the safety and toxicity of imatinib mesylate when given to patients with Ph (+)~     CML , ALL or AML within the first 100 days following allogeneic bone marrow or stem cell~     transplantation.~      Secondary Objectives:~        1. To identify any clinically significant drug interactions with imatinib in the~          post-transplant setting.~        2. To develop specific monitoring parameters for imatinib use when utilized in the early~          post-BMT setting.~        3. To record one-year survival data in this patient cohort to assess any effect of early~          imatinib administration on this endpoint.~   "
242044|NCT00386360|"~     The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral~     Quantitative Computed Tomography) technology to detect minute changes in bone~     microarchitecture.~   "
242045|NCT00386347|"~     This study is a two-part study. Part one is designed to see how different formulations of~     GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in~     the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in~     the body.~   "
242046|NCT00386334|"~     To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in~     elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at~     bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be~     safe and well tolerated, improve subjective sleep measures, improve measures of Quality of~     Life and next day insomnia symptoms, and have no significant withdrawal central nervous~     system adverse events or rebound insomnia.~   "
242047|NCT00386321|"~     The purpose of this study is to determine whether the treatment of Yt90 Zevalin in~     combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)are~     effective as first line treatment in patients with bulky stage II or stage III or IV diffuse~     large B-cell lymphoma~   "
242048|NCT00386308|"~     The purpose of this study is to determine whether XP12B is effective and safe in the~     treatment of women with heavy menstrual bleeding associated with menorrhagia.~   "
242049|NCT00386282|"~     This study examined the acceptability and feasibility of introducing a~     mifepristone-misoprostol regimen of medical abortion into abortion services in two private~     clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4~     clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable~     and efficacious.~   "
242050|NCT00386269|"~     This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in~     infants receiving morphine after surgery. Codeine may be effective enough to make morphine~     unnecessary.~   "
242051|NCT00386256|"~     The purpose of this study is to develop a home exercise program for patients 60 years of age~     and over who are deconditioned following their discharge from the hospital, or recruited from~     GLA outpatient clinics. The program will be designed to monitor and improve patients'~     exercise behavior through the use of home technology, such as text messaging monitors.~   "
242052|NCT00386243|"~     The purpose of this study is to determine if a stepped-care intervention makes pain symptoms~     better and reduces activity limitations because of pain. Our two primary hypotheses are that~     in OIF/OEF veterans with chronic pain:~        1. Stepped care is more effective than usual care in reducing pain-related disability~        2. Stepped care is more effective than usual care in reducing psychological distress~   "
242053|NCT00386230|"~     The purpose of the study was to test the equivalence of a short zidovudine (ZDV) regimen as~     compared to a longer, ACTG-076-like, ZDV regimen in reducing the risk of mother-to-child~     transmission of HIV: and to assess and compare the safety and tolerance of the long and~     shortened ZDV regimens.~   "
242054|NCT00386217|"~     The success of cancer treatment combined with the trend to delay childbearing is increasing~     the numbers of women survivors whose childbearing has been interrupted by cancer. For some,~     treatment has resulted in infertility. Others have been advised to delay pregnancy until a~     certain follow-up interval or have new fears that pregnancy could be a risk to maternal~     health. Not least is the concern that children born after a mother's cancer would face~     increased risks for birth defects or cancer.~      The specific aims of this project are as follows:~        1. To measure the impact of cancer-related interruption of childbearing on women's~          long-term emotional well-being and health-related quality of life, over and above other~          demographic and cancer-related factors~        2. To find out if becoming a biological or social mother after cancer treatment decreases~          the long-term psychosocial impact of interrupted childbearing compared to remaining~          childless~        3. To refine the psychometric properties of questionnaires for female cancer survivors~          measuring Distress about Cancer-Related Childbearing Issues and Attitudes towards~          Parenthood after Cancer~        4. To define targets for a future intervention to improve female survivors' knowledge about~          childbearing after cancer, decrease distress associated with interrupted childbearing,~          and promote peer support.~   "
242055|NCT00386204|"~     The purpose of this study is a comparison of efficacy and side effects of Q-switched Ruby~     laser treatment for solar lentigines in two different skin types II and IV.~   "
242056|NCT00386191|"~     The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral~     infarction with respect to incidence of bleeding adverse events.~   "
242057|NCT00386178|"~     Gamma tocopherol (gt) is a naturally occurring form of vitamin E that is found in many foods,~     and is also commercially available as a vitamin supplement. The purpose of this Phase 1~     research study is to see if two doses of gt, 600mg and 1200mg, are safe (do not cause~     gastrointestinal distress or other problems), and can cause changes in your blood levels of~     gt and other antioxidants. This study will also examine if there is a difference in response~     between asthmatic and non-asthmatic adults when taking the same dose of gt. Phase 1 research~     studies like this one are not intended to be a treatment, but are a scientific investigation.~   "
242058|NCT00386165|"~     To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients~     with controlled celiac disease on a gluten-free diet following a gluten challenge.~   "
242059|NCT00386152|"~     The purpose of this study is to compare hemoglobin response rates between two PROCRIT~     (epoetin alfa) doses and ARANESP (darbepoetin alfa) in anemic cancer patients receiving~     chemotherapy~   "
242060|NCT00386139|"~     Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and~     HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure~     response to aliskiren 300 mg.~   "
242061|NCT00386126|"~     Anemia has been demonstrated to be a common finding in patients with heart failure (HF).~     Previous studies in hospitalized patients with HF have found a prevalence of anemia ranging~     from 15% to 63%. More importantly, anemic patients with HF have increased morbidity and~     mortality. The mechanisms underlying anemia in HF are multifactorial, involving mild to~     moderate forms of anemia of chronic disease and ferropenic anemia. The clinical impact of~     iron supplementation in HF patients who have a relatively preserved renal function and either~     chronic disease anemia, ferropenic anemia or both remains largely unknown. The route of iron~     administration that could be most clinically effective is also unclear. Thus, the primary aim~     of the IRON-HF study is to assess the effects of iron supplementation alone (IV or PO) on~     parameters of functional capacity in HF patients with anemia with decreased availability of~     iron.~   "
242062|NCT00386113|"~     Since influenza vaccines are normally administered every year because of the frequent change~     in their antigenic composition, the safety and immunogenicity profile of adjuvanted influenza~     vaccine need to be re-evaluated after repeated vaccine administration. In this study,~     subjects previously vaccinated with Fluarix or the influenza adjuvanted vaccine, will receive~     a booster dose with the 2006-2007 season's formulations of either Fluarix or the adjuvanted~     vaccine.~   "
242063|NCT00386100|"~     This study will evaluate the longer-term glycemic effect of two medicines approved for~     initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2~     study visits), followed by an 80 week double-blind treatment period (11 study visits). Also,~     a sub-study was included to look at changes in bone mineral density (BMD) at the lumbar~     spine.~   "
242064|NCT00386087|"~     The purpose of this study is to determine the effectiveness of enzastaurin in the treatment~     of patients with metastatic breast cancer.~   "
242065|NCT00386074|"~     The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron~     status of young school children, when added as iron fortificants in whole maize flour.~   "
242066|NCT00386061|"~     The primary objective was to assess the effect of SR141716 on weight loss and weight~     maintenance over a period of one year when prescribed with a hypocaloric diet in obese~     patients with or without comorbidities.~      The main secondary objectives were to assess the effect of SR141716 on lipid parameters~     (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist~     circumference, glycemic parameters.~   "
242067|NCT00386048|"~     Sickle cell disease (SCD) is a devastating chronic health condition that primarily affects~     African-Americans. Painful episodes are the most frequent form of morbidity in SCD and the~     most frequent reason for hospitalization. Cognitive-behavioral interventions for pain~     management have shown efficacy for improving coping abilities, reducing the amount of~     medication needed to manage pain, and improving daily functioning during painful episodes.~     However, difficulties with disseminating and implementing cognitive-behavioral treatments~     have resulted in almost no use of these techniques in pediatric settings. In South Carolina~     these difficulties are compounded by social and geographical factors that pose particular~     challenges. A major issue with implementing quality pain management protocols is the~     difficulty with providing adequate practice and monitoring of the use of the techniques,~     particularly given the rural population in South Carolina and transportation difficulties for~     economically disadvantaged families. Due to a history of under-treating pain in SCD it is~     also critical that psychological and medical treatments are presented in an integrated manner~     so that these approaches are viewed as complimentary, not mutually exclusive, approaches to~     pain management. Finally, we believe the same implementation issues for improving the use of~     behavioral coping skills are also important for improving adherence to medication protocols~     for appropriate home-based pain management.~      The purpose of this proposal is to develop, implement, and evaluate a pain management~     protocol that uses portable electronic devices and other technologies to increase the~     practice of psychosocial pain management techniques, improve adherence to the overall~     biopsychosocial pain management protocol, and improve the clinician's ability to track~     progress with fewer office visits. In addition to addressing important dissemination issues,~     by embedding methods to assess for adherence into the technology it will be possible to~     continuously evaluate and modify protocol efficacy, resulting in a product that is effective,~     empirically sound, and flexible. Participants will be randomly assigned to the intervention~     or waitlist control condition. Those on the waitlist condition will receive the same study~     procedures after a 2 month wait periods. We anticipate that the intervention will result in~     better pain management and less impairment in the participants.~   "
242068|NCT00386035|"~     The purpose of this study is to compare the effects of two different anti-HIV drug regimens~     on HIV transmission risk behavior among SMART study participants.~   "
242069|NCT00386022|"~     The purpose of this study is to study the effects of aging and estrogen on the brain.~     Specifically, this study will examine how the hypothalamus signals the pituitary gland to~     secrete reproductive hormones and how that changes with aging.~   "
242070|NCT00386009|"~     The purpose of this study is to evaluate the function of the bladder and urethra during~     urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia~     treated with either placebo or tadalafil.~   "
242071|NCT00385996|"~     The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking~     tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the~     tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib)~     . This type of CT scan will measure the tumor by volume and by standard measurement (length~     and width). Both methods will be compared to find out whether standard measurement or~     measurement by tumor volume is more accurate.~   "
242072|NCT00385983|"~     Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients~     submitted to total thyroidectomy. Few randomized controlled trials has been published.~     However they had small sample sizes, used intermediate outcomes and included different~     surgical procedures.~      Our objective is to asses the use of Harmonic scalpel in patients submitted to total~     thyroidectomy using surgical complications, operative time, drainage volume, postoperative~     pain, length of stay and costs as outcomes. Our hypothesis is that Harmonic scalpel decreases~     operative time,drainage volume, postoperative pain, length of stay and costs without~     increasing surgical complications~   "
242073|NCT00385970|"~     To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV)~     administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with~     pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized~     open-label comparative controlled study and consequently to determine the usefulness of the~     above regimens as adjuvant therapy after surgery.~   "
242074|NCT00385957|"~     The study analyzes the virological response in plasma and non-plasma compartments, as well as~     the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 <~     100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease~     inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).~   "
242075|NCT00385944|"~     This is a multicenter, randomized, double-blind, cross-over study to compare the~     pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg~     maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel,~     following a 900-mg loading dose (LD) of clopidogrel.~   "
242076|NCT00385931|"~     This study will assess and compare the efficacy and safety of valsartan and the combination~     of valsartan and simvastatin in patients with high blood pressure and high cholesterol.~   "
242077|NCT00385918|"~     This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is~     feasible in people with motor incomplete spinal cord injury, and three months of training~     will improve cardiovascular fitness and gait functionality when compared to physical therapy~     controls~   "
242078|NCT00385905|"~     The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of~     restenosis as well as the safety after the cessation of the 6-month anti-platelet drug~     treatment.~   "
242079|NCT00385892|"~     This safety study was carried out to investigate to what extent the use of an abdominal~     binder influences IAP. The study was designed as a comparative cross-over study measuring~     bladder pressure.~   "
242080|NCT00385879|"~     The purpose of this study is to evaluate whether or not case management by a social worker~     and nurse can decrease the number of emergency room visits, increase the number of primary~     care doctor visits, and increase quality of life of people in a Medicaid managed care plan.~   "
242081|NCT00385866|"~     To reduce Cancer health care disparities that exists among minority Medicare beneficiaries~     and to demonstrate cost effectiveness of patient navigation in reducing the burden of cancer.~   "
242082|NCT00385853|"~     PTK is an investigational new drug that has been shown in early laboratory studies to prevent~     the formation of new blood vessels that allow the tumor to grow. These studies have shown~     that the study drug can potentially improve the effectiveness of additional radiation and~     chemotherapy. With this study, we would like to examine the effects of PTK when used in~     combination with radiation therapy and the anti-cancer drug temozolomide, the standard~     treatment for patients with newly diagnosed glioblastoma. We would also like to learn how the~     study drug is absorbed, distributed, and cleared from the body.~   "
242084|NCT00385827|"~     The purpose of this study is to assess the safety and efficacy of siltuximab administered in~     combination with mitoxantrone and prednisone in participants with metastatic (spread of~     cancer cells from one part of the body to another) hormone-refractory (not responding to~     treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).~   "
242085|NCT00385801|"~     The purpose of this study is to examine the effects of the administration of~     Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI),~     behavioral tests and measuring cocaine craving and use among people with active cocaine~     dependence.~   "
242086|NCT00385788|"~     The goal of this clinical research study is to learn if fludarabine, melphalan and~     gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune~     cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or~     a mismatched related donor, can help to control Hodgkin's disease. The safety of the~     treatment will also be studied.~   "
242087|NCT00385775|"~     This study is designed to find the maximum tolerated dose, safety and toxicity profile, and~     to identify any dose limiting toxicities of AEG35156 administered in 2-hour infusions to~     patients with advanced cancers.~   "
242088|NCT00385762|"~     According to the National Institute of Mental Health, depressive disorders afflict over six~     million U.S. men annually. Most cases of moderate or severe depression are treated with~     antidepressants, including monoamine oxidase inhibitors, tricyclic antidepressants, and, more~     recently, selective serotonin reuptake inhibitors (SSRIs) and antidepressants with modest~     serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action. Over the~     past two years, prescribing data show a steady increase in antidepressant dispensing rates~     (especially including serotonin reuptake inhibitors) for adults. SSRIs are known to have an~     effect on ejaculatory function and are therapeutically used for treatment of premature~     (rapid) ejaculation. However, few studies have evaluated the potential impact of~     antidepressant medications on male fertility, and no studies have been published with respect~     to the impact of newer antidepressants, such as SSRIs, on male fertility. In the high-volume~     male infertility practice at New York Hospital-Cornell Medical Center, several patients have~     presented who have had a clear temporal association between SSRI use and impairment in sperm~     motility and/or sperm transport (emission). These men have shown improvement in sperm counts~     and motility after discontinuation of antidepressant medications.~   "
242089|NCT00385749|"~     This study will compare single coil right ventricular defibrillation leads for implanted~     cardioverter/defibrillators (ICDs) in the apical and high septal locations. It is~     hypothesized that RV septal positions are at least as good as apical positions using formally~     measured defibrillation thresholds(DFTs), and that they may have long term advantages in~     reducing left ventricular dysfunction.~   "
242090|NCT00385736|"~     The objective of this study is to assess the efficacy and safety of adalimumab for the~     induction of clinical remission in subjects with moderately to severely active ulcerative~     colitis.~   "
242091|NCT00385723|"~     This study is designed to examine the effects of fish oil on immune function and mood.~   "
242092|NCT00385710|"~     Progressive Supranuclear Palsy (PSP) is a relentlessly progressive neurodegenerative~     disorder, clinically characterized by parkinsonism with prominent axial involvement and~     postural instability, bulbar symptoms, supranuclear ophthalmoplegia, and executive~     dysfunction. Abnormal neuronal and glial tau aggregations affecting the basal ganglia and~     selective brainstem structures result in dysfunction of the five frontosubcortical circuits~     and brainstem functions. There is no effective treatment for PSP. One of the key feature in~     the aggregation of tau is its phosphorylation by kinases such as glycogen synthase kinase 3b~     (GSK3b). Recent reports have shown that valproic acid was able to inhibit the activity of~     GSK3b and could exert a neuroprotective effect through this inhibition. The investigators~     thus decided to conduct this controlled study to assess the putative neuroprotective effects~     in patients with PSP.~   "
242093|NCT00385697|"~     The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of~     MGA031 when administered according to 3 different MGA031 dosing regimens in children and~     adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All~     regimens will be administered as an addition to insulin and other standard of care~     treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce~     typical insulin requirements while maintaining relatively normal blood sugar levels.~      Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized~     monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics,~     Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.~   "
242094|NCT00385684|"~     The purpose of this study was to determine whether a low dose an opiate pain medication is~     effective for the treatment of discomfort in patients with advanced dementia. The study~     medication was also known as Lortab and contained both a narcotic pain medication and~     acetaminophen (the same pain medication as contained in Tylenol). This study was an~     eight-week long clinical trial for discomfort among veterans with advanced dementia who were~     admitted to a Nursing Home Care Unit (NHCU) at the Tuscaloosa VA Medical Center.~   "
242095|NCT00385671|"~     To test the non-inferiority of duloxetine monotherapy as a treatment for the management of~     diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who~     have not had an adequate response to gabapentin.~   "
242096|NCT00385658|"~     This study will investigate the effects of the combination of fluvastatin and fenofibrate on~     dyslipidemia in comparison to the combination of simvastatin and ezetimibe.~   "
242097|NCT00385645|"~     The study compares the adherence of 240 HIV-negative subjects randomly assigned to 2~     different antiretroviral therapies for 28 days after accidental exposure to HIV.~   "
242098|NCT00385632|"~     The purpose of this study is to compare the effects of two different anti-HIV drug regimens~     on quality of life and health care utilization among SMART study participants.~   "
242099|NCT00385606|"~     The purpose of this study is to evaluate the tolerability and efficacy of the addition of~     rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous~     infusion of gemcitabine in combination with cisplatin in the treatment of patients affected~     by advanced non-small cell lung cancer.~   "
244560|NCT00352911|"~     The objective of the study is to determine whether mifepristone (VGX-410) has anti-HIV-1~     activity at doses of either 300 mg or 600 mg per day after oral administration for 14 days at~     each dose level.~   "
242100|NCT00385593|"~     This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a~     more general setting in order to assess the real-life impact of introducing this new~     treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a~     conventional stepwise treatment regimen according to the investigator's judgement in patients~     who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and~     are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).~   "
242101|NCT00385580|"~     The purpose of this study is to learn if men with metastatic prostate cancer and rising~     Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing~     androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to~     dasatinib. The safety of this treatment will also be studied.~   "
242102|NCT00385567|"~     HRG2 is a Phase 2 randomized, controlled, open-label, multi-dose trial to determine the~     efficacy, safety, immunogenicity, and pharmacokinetic profile of PEHRG214 in HIV-infected~     patients, treated three times weekly for up to 16 weeks.~      All patients are receiving optimized standard of care HAART.~      The primary objective of the study is to determine the effect of PEHRG214 in decreasing the~     viral load (>=1.0 log10), as compared to a Control group. The primary hypothesis is that~     treatment with PEHRG214 will result in clinically meaningful and sustained viral load~     suppression.~      The total sample size is 70-74 patients from approximately 8-10 participating study centers.~     The first 16-20 patients are enrolled in the non-randomized pilot arm and 54 subsequent~     patients are randomized (2:1 within center) to Treatment or Control group. The total study~     duration is 7-12 months.~   "
242103|NCT00385554|"~     This study will test the safety, side effects, and acceptability of two strengths of UC-781~     gel when used by women and men in Botswana for two weeks.~   "
242104|NCT00385541|"~     Both morphine and hydromorphone are pain medications commonly used after surgery. It is~     thought at our institution that hydromorphone causes less side effects but this has not been~     studied. We propose to treat our patients with either morphine or hydromorphone and determine~     how much nausea, vomiting, and itching they have with each drug~   "
242105|NCT00385528|"~     Background: somatic patients with psychiatric co-morbidities are a major challenge for the~     health care system. This study evaluated a psychiatric intervention targeted at the complex~     medically ill identified by means of the INTERMED, an instrument to assess case complexity.~      Methods: of 885 rheumatology inpatients and diabetes outpatients who were assessed for~     eligibility, 247 were identified as complex (INTERMED score > 20) and randomized to the~     intervention (N=125, 84 rheumatology and 41 diabetes patients) or care as usual (N=122, 78~     rheumatology and 44 diabetes patients). Intervention consisted of counseling by a psychiatric~     nurse, referral to a liaison psychiatrist, or a multidisciplinary case conference. Baseline~     and follow up at months 3, 6, 9 and 12 measured prevalence of major depression (MINI),~     depressive symptoms (CES-D), physical and mental health (SF-36), quality of life (EuroQol),~     hospitalizations (rheumatology patients) and HbA1c levels (diabetic patients).~   "
242106|NCT00385515|"~     Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT)~     regimens and by radiation to the head and neck. The purpose of this study is to determine the~     effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM)~     according to World Health Organization (WHO) criteria.~   "
242107|NCT00385502|"~     Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will~     be treated for 48 weeks with lacquer application to at least one affected great toenail. All~     subjects will receive treatment with EcoNail™ lacquer.~   "
242108|NCT00385489|"~     The purpose of this study is to evaluate the safety of LXR-623 in healthy Japanese subjects.~   "
242109|NCT00385476|"~     The goal of the study is to learn about patients' knowledge of their medications in an~     outpatient acute care setting (such as the M. D. Anderson Emergency Center) and to learn~     about any clinical factors that affect patients' knowledge of their medications.~   "
242110|NCT00385463|"~     The four respiratory drugs being researched in this study have been approved by the US Food~     and Drug Administration (FDA) and are currently available by prescription at your drug store.~     One of the drugs is for the treatment of asthma alone, one is for treatment of SAR alone, and~     one is for treatment of both SAR and asthma. In addition, you will also receive one asthma~     rescue drug (albuterol) that is to be used for any breakthrough asthma symptoms that you may~     experience throughout the study.~      The purpose of this study is to see how well your asthma and SAR are controlled when taking~     one of the medicine combinations~   "
242111|NCT00385450|"~     In previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure~     manifested CD4 counts of less than 500 cells/microliter in the immediate (day 1)~     post-operative period. This study will investigate whether or not Nelfinavir increases those~     CD4 counts in the post-operative period.~   "
242112|NCT00385437|"~     This concurrent, two-part study will:~      I) Using overnight sleep recordings, evaluate the short- and long-term sleep-promoting~     effects of the antidepressant mirtazapine (Remeron) in patients who have been prescribed this~     medication for major depressive disorder and sleep disruption.~      II) Investigate the psychomotor performance of depressed patients using driving simulation~     testing before and during treatment with mitrazapine.~   "
242113|NCT00385411|"~     Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of~     valproate administered as microgranules, under standard prescription conditions, with~     therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations~     and antiepileptic comedication as well as biological assays.~      Secondary objectives: Ancillary population kinetics study~        -  Estimate the pharmacokinetic parameters of valproate administered as microgranules under~          standard therapeutic conditions within the population studied, from the therapeutic~          follow-up data.~        -  Evaluate the influence of individual characteristics on the pharmacokinetic parameters.~        -  Describe the relationship between plasma concentrations and adverse events for valproate~          and the main anti-epileptic comedications.~   "
242128|NCT00385216|"~     Third molar surgery is complicated by pain and swelling for several days after surgery.~     Non-steroidal antiinflammatory drugs have been useful in combination with opioids for~     treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine~     or placebo as a nasal spray before surgery to determine whether nicotine affects pain or~     inflammation.~   "
242114|NCT00385398|"~     RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function~     (the ability to think, learn, remember, and judge) in patients with non-small cell lung~     cancer and brain metastases. A study that evaluates brain function may help doctors plan the~     best treatment.~      PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and~     erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.~   "
242115|NCT00385385|"~     The objective of this study is to evaluate an antibiotic therapy called Rifalazil to~     determine its effect on hardening of the carotid arteries.~   "
242116|NCT00385372|"~     Patients with chronic urticaria undertake a five week elimination diet (pseudoallergen free~     diet). The efficacy of the diet will be determined by symptom score, by the use of rescue~     medication (oral antihistamines and glucocorticosteroids) and by a Quality of Life~     Questionnaire on week 0 and week 5. All patients with sufficient response (regarding the~     urticaria score) enter a second dietary part over six weeks, whereas a provocation diet is~     carried out. Each diet week a choice of pseudoallergen rich food is added, sorted by the type~     of pseudoallergens (e.g. biogenic amines, organic acids, flavours, additives). This study is~     conducted to investigate if the provocation diet could be a new diagnostic intervention to~     elucidate clinical relevant pseudoallergens.~   "
242117|NCT00385359|"~     Albuterol (salbutamol) is a widely used asthma medication but is associated with undesirable~     side effects such as shakiness and increased heart rate. Targeted delivery of albuterol to~     area of lungs where it has most effect would require a lower total dose to produce the same~     beneficial effects while reducing the side effects.~      It is anticipated that only 1/13th to 1/25th of the standard nebulized dose of albuterol will~     be required to attain same bronchodilator response as a standard nebulizer treatment as~     determined by lung function measurement and that the reduced dose will significantly reduce~     side effects as determined by hand tremor and heart rate.~   "
242118|NCT00385346|"~     The purpose of this study is to determine whether expressive writing can be effective in~     improving the well-being and sperm quality in patients with male infertility.~   "
242119|NCT00385333|"~     This study will test whether a new non-invasive technique can quickly and precisely measure~     retinal metabolism (the amount of energy retinal cells use). The retina is the part of the~     eye that sends information to the brain.~      Participants in current NEI studies who have age-related macular degeneration (AMD), diabetic~     retinopathy, or von Hippel-Landau disease may be eligible for this study. Healthy volunteers~     will participate as controls. Patients with AMD must be 60 years of age or older; those with~     VHL disease or diabetic retinopathy must be 18 or older.~      Participants undergo the tests and procedures required in the NEI study in which they~     previously enrolled. In addition, for the current study, they undergo metabolic mapping. For~     this procedure, the subject's eyes are dilated, and different amounts of low-level light are~     shone into the eye to see how different cells respond with changes in metabolism.~     Measurements are taken while the subject breathes room air and while he or she breathes~     medical grade oxygen for about 1 minute. The entire procedure takes about 15 minutes.~   "
242120|NCT00385320|"~     The purpose of this study is to test how infants respond to different strengths of the human~     rotavirus vaccine.~   "
242121|NCT00385307|"~     To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared~     to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as~     positive control. In addition, the tolerability and safety of SR58611A in patients with MDD~     will be evaluated.~   "
242122|NCT00385294|"~     We wish to understand why labor is more painful for some women compared to others.We will~     study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor genotype is~     related to her pain in labor for the birth of a first child.~   "
242123|NCT00385281|"~     The purpose of this study is to look at changes that occur in blood and nasal swab samples~     after a person's immune system responds to receiving a flu vaccine. The investigators will~     look at the immune response in 50 healthy volunteers, between 21 and 49 years of age, after~     they have been vaccinated with 1 dose of a flu vaccine sprayed into the nose. A blood sample~     and nasal swab of each nostril will be collected from volunteers before they receive the flu~     vaccination. After receiving the flu vaccine, volunteers will record health changes and daily~     temperatures on diary cards at home for 21 days. Blood will be drawn and nasal swabs will be~     collected from each volunteer at each of the 6 study visits. Volunteers will participate in~     the study for approximately 1 month. This study is being conducted at the Glennan Center for~     Geriatrics and Gerontology at Eastern Virginia Medical School.~   "
242124|NCT00385268|"~     Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of~     cocaine dependence.~   "
242125|NCT00385255|"~     The current study will provide information for the use of Boostrix concomitantly with~     influenza vaccine in adults aged 19-64 years. This study will also provide safety and~     immunogenicity data in a cohort of adults aged greater than or equal to 65 years.~   "
242126|NCT00385242|"~     Rationale: Patients with severe ventricular dysfunction and coronary disease have high~     morbidity and mortality. They may benefit from revascularization, but have significant~     peri-operative morbidity and mortality. Positron emission tomography (PET) imaging with~     F-18-fluorodeoxyglucose (FDG) can detect viable myocardium that may recover from~     revascularization in such patients. It is unclear whether use of FDG PET in this population~     is improves outcome or is cost-effective.~      Objectives: The principal aim is to determine whether FDG PET-guided therapy is effective~     versus standard care. Secondary objectives are to determine whether FDG PET-guided therapy~     improves LV function, quality of life and is good value for money versus standard care.~   "
242127|NCT00385229|"~     Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether~     induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity~     compared to expectant management. Secondary aims was to assess the effect on mode of delivery~     and maternal complications, as well as assess women's views and experiences.~      Our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better~     outcome of pregnancy, measured as perinatal morbidity.~      Following inclusion, women were randomly allocated to induction of labor or to monitoring of~     pregnancy every third day until delivery~   "
242193|NCT00384358|"~     The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as~     an adjuvant to internal fixation in subjects with fractures of the proximal femur.~   "
242129|NCT00385203|"~     To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose~     of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to~     imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue~     Sarcoma (STS) resistant to standard therapy.~   "
242130|NCT00385190|"~     The purpose of the study is to assess the safety and tolerability of ascending multiple oral~     doses of HCV-796 in healthy Japanese male subjects.~   "
242131|NCT00385177|"~     This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced~     solid malignancies. The study is designed to determine the maximum tolerated dose and~     dose-limiting toxicity of SN2310 Injectable Emulsion, and to characterize the~     pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310~     Injectable Emulsion. Additionally, evaluation of side effects as a function of dose, and~     observation of any anti-tumor effects of SN2310 Injectable Emulsion will be made.~   "
242132|NCT00385164|"~     Patients planned for radical radiation for NSCLC will undergo conventional CT stimulation and~     also PET/CT scans for definition of radiation target volumes~   "
242133|NCT00385151|"~     Reperfusion Injury occurs by the sudden blood flow to the injured and ischemic myocardium~     during restoration of blood flow either by Mechanical revascularization or thrombolysis. A~     phenomenon known as Pre-conditioning has been identified to limit the the extent and severity~     of reperfusion injury but it is very difficult to apply it in patient care setting as timing~     of acute cardiac or neurologic ischemic event is difficult to reliably predict.~      Postconditioning or ischemic postconditioning is well known to attenuate the reperfusion~     injury. There is enough data that shows the benefit of post conditioning in reducing the~     reperfusion injury in animals. However postconditioning in humans has not been investigated.~      We hypothesize that Post conditioning will attenuate the reperfusion injury and will be~     comparable to the effect of preconditioning in humans.~   "
242134|NCT00385138|"~     The primary objective of this study is to demonstrate that the efficacy of cangrelor~     (combined with usual care) is superior to that of usual care, in subjects requiring~     percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality,~     myocardial infarction (MI), and ischemia-driven revascularization (IDR).~   "
242135|NCT00385125|"~     Phase II study for treatment of patients with relapsed or primary refractory aggressive B-~     cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for~     autologous stem cell transplantation.~   "
242136|NCT00385112|"~     The purpose of this study is to determine if the Medtronic Freestyle porcine valve is~     effective over a long period of time when it is used to replace the valve that normally~     allows blood to flow from the right lower pumping chamber of the heart to the lungs.~   "
242137|NCT00385099|"~     The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will~     reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.~   "
242138|NCT00385086|"~     TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis.~     Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.~   "
242139|NCT00385073|"~     Participants will complete a self-selected intensity of exercising over a 6 month period,~     with detailed clinical assessments at commencement and completion to determine the rate of~     progression of parkinsonism and gait abnormalities~   "
242140|NCT00385047|"~     The purpose of this study is to determine whether 2 investigational malaria vaccines are safe~     as well as protective against malaria in adults living in the United States~   "
242141|NCT00385034|"~     This study tested the effectiveness of computer-assisted screening for identifying patients~     at risk of intimate partner violence (IPV) in a Canadian family practice. It was hypothesized~     that the use of computer-assisted screening among female patients would lead to higher rates~     of IPV discussion-opportunity and IPV detection during medical consultations, compared to~     patients receiving standard medical care.~   "
242142|NCT00385021|"~     To determine efficacy in the delivery of chronomodulated chemotherapy.~   "
242143|NCT00385008|"~     An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and~     naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.~   "
242144|NCT00384995|"~     Slowing of kidney function occurs in a minority of people given dye during angiography. The~     purpose of this study is to compare two different types of fluid given into a vein to reduce~     the risk of kidney injury: salt in water or baking soda in water.~   "
242145|NCT00384982|"~     The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a~     multicenter, prospective, randomized, single-blind clinical trial designed to compare the~     early and late intracoronary or combined (percutaneous intramyocardial and intracoronary)~     administration of bone marrow-derived stem cells to patients after acute myocardial~     infarction with reopened infarct-related artery.~   "
242146|NCT00384969|"~     The objective of the phase I part of the study is to determine the maximum tolerated dose and~     dose limiting toxicities of the combination of RAD001 and sorafenib in patients with~     untreated metastatic kidney cancer.~   "
242147|NCT00384956|"~     The primary endpoint of this study is to estimate morphologic complete remission rate.~     Estimation of response rate is also a secondary objection.~   "
242148|NCT00384943|"~     The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise~     program for the treatment of postpartum depression.~   "
242149|NCT00384930|"~     This is a randomized, double-blind, placebo-controlled, parallel-design, multinational,~     12-week study to compare the efficacy, dose response, and safety of tadalafil once a day~     versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including~     lower urinary tract symptoms.~   "
242150|NCT00384917|"~     An open label, 2-period, sequential study to determine the impact of multiple doses of~     ketoconazole on single-dose pharmacokinetics of HCV-796~   "
242151|NCT00384904|"~     The purpose of this clinical research study is to assess the effect of Famotidine given twice~     daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.~   "
242152|NCT00384891|"~     The study is designed to compare the efficacy and safety of 2 treatment types for the~     prevention of tumor recurrence of superficial bladder cancer:~        1. A combination of bladder wall heating and local chemotherapy (Synergo)~        2. Bacillus Calmette-Guérin (BCG)~   "
242153|NCT00384878|"~     The primary end point of the study is confirmed objective response rate (complete response~     [CR] and partial response [PR]). A response rate of 80 percent for cetuximab plus cisplatin~     and weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin (P-HDFL) chemotherapy~     is assumed. The Simon two-stage design will be used for P1 - P0 = 0.20. The response rates of~     interest are P0 = 60% and P1 = 80%. The investigators will reject cetuximab plus P-HDFL~     chemotherapy if the response rate is 8/13 at the first stage, and will reject the cetuximab~     plus P-HDFL chemotherapy if the response rate is 25/35 at the second stage. If there are more~     than 8 responses in 13 patients in the first stage, the study will continue to a total of 35~     patients in the second stage. If there are more than 25 responses in 35 patients in the~     second stage, this treatment will be acceptable with a p-value of 0.05 and of 0.20. Evaluable~     patients for response will be those who received at least 4 doses of cetuximab (i.e. one~     cycle of protocol treatment). All enrolled patients will be subjected to toxicity~     evaluations.~      The primary end point of the study is confirmed objective response rates (by RECIST, Response~     Evaluation Criteria in Solid Tumors). The secondary end points of the study are~     progression-free survival, overall survival, and treatment-related toxicities.~      The analysis of response to treatment will be restricted to the eligible patients with at~     least one measurable lesion. The safety analysis will be restricted to the patients who~     received at least one cycle of the administered chemotherapy. The time-to-event end points~     will be estimated using the method of Kaplan and Meier and based on the intent-to-treat~     principle. Overall survival will be defined as the time interval between the date of study~     entry and the date of death. Progression-free survival will be defined as the time interval~     between the date of study entry and the date of disease progression or death, whichever~     occurred first. Duration of response will be defined as the time interval between the date of~     initial objective response and the date of disease progression, which is only for responders.~     If the event is not yet observed at the time of the last record, the patient will be censored~     at that time point.~   "
242154|NCT00384865|"~     The purpose of this study is to determine whether aspirin and simvastatin are safe and~     effective for the treatment of pulmonary arterial hypertension (PAH).~   "
242155|NCT00384852|"~     The primary objective of this study is to assess whether fracture union is accelerated in~     subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy~     (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard~     of care alone.~   "
242156|NCT00384839|"~     The purpose of this research study is to find out what effects (good and bad) Vidaza has on~     patients with prostate cancer. This investigational drug is not approved by the Food and Drug~     Administration (FDA) for the treatment of prostate cancer; however, it is approved in~     myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this~     study, Pharmion Corporation, is the manufacturer of Vidaza.~   "
242157|NCT00384826|"~     To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control~     rate after 4 months treatment of an early therapeutic permutation with the first month in the~     absence of stabilization or objective answer.~   "
242158|NCT00384813|"~     Stress and anxiety can negatively affect children with asthma. Reducing the stress of~     asthmatic children and their families may lead to improved asthma care and fewer asthma~     symptoms in the children. The purpose of this study is to develop and evaluate a~     family-focused asthma education program aimed at reducing stress levels and improving asthma~     care for urban children with asthma.~   "
242159|NCT00384800|"~     Primary objective:~      To evaluate the overall response rate of tegafur/uracil (UFUR®) and thalidomide in the~     treatment of advanced or metastatic hepatocellular carcinoma.~      Secondary objectives:~        1. To determine the disease stabilization rate;~        2. To assess the progression-free survival and overall survival;~        3. To establish the safety profile;~        4. To evaluate the changes of circulating factors indicating the angiogenesis activity and~          their correlation with objective tumor response.~   "
242160|NCT00384787|"~     The purpose of this study is to determine the safety of, immune response to, and tolerability~     of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine.~     The adenoviral vaccine will be given into arm muscle (intramuscularly), between skin layers~     (intradermally), or under the skin (subcutaneously).~      NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were~     discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued.~     Participants will be followed for safety and immune responses at regular study visits.~   "
242161|NCT00384774|"~     This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment~     of migraine headache in order to select a dose range for further studies.~   "
242162|NCT00384761|"~     To establish normal values by age, race, and gender of novel markers of risk in healthy~     subjects necessary to predict precise risk of cardiovascular disease in an individual~   "
242163|NCT00384748|"~     The purpose of the proposed study is to examine a Tele-rehabilitation (TR) intervention that~     uses tele-health technology to improve outcomes of stroke patients after discharge to home.~     The primary aim is to determine the effect of TR on physical function, and secondarily to~     determine the effect on disability, falls-related self-efficacy, and patient satisfaction.~   "
242164|NCT00384735|"~     The purpose of this study is to evaluate the impact on overall survival of an intensive~     follow-up protocol (as practiced today at TMH) against a more cost effective follow-up~     protocol in patients operated for extremity sarcoma.~   "
242165|NCT00384722|"~     The primary objective of this clinical investigation is to evaluate the safety and~     effectiveness of the EASYTRAK 3 Downsize Lead.~   "
242166|NCT00384709|"~     Nursing home patients admitted to the hospital pose a significant challenge for health care~     providers. Geriatric teaching pays particular attention to these admissions and related~     problems. However, it is yet to be proven, whether geriatric training helps to overcome any~     of these issues in a better way than through non-geriatric education. The study aims to prove~     that geriatric training provides advantages over non-geriatric training in caring for nursing~     home patients admitted to the hospital.~   "
242167|NCT00384696|"~     The goal of this behavioral research study is to put together and study a treatment for~     nicotine dependence that looks at how participant's thoughts and feelings about smoking may~     be related to how successfully they quit smoking.~   "
242168|NCT00384683|"~     The goal of this clinical research study is to learn whether the inability of certain blood~     vessel cells (endothelial cells) to function properly may help researchers to predict who is~     at risk for complications after surgery and whether this dysfunction contributes to~     complications after surgery. This study will use a blood test to quantify the number of cells~     that are destined to become endothelial cells.~   "
242169|NCT00384670|"~     To assess the safety, reactogenicity and immunogenicity of two doses of the dengue vaccine in~     Flavi-virus antibody-naive children between 6 and 9 years of age.~   "
242195|NCT00384332|"~     This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg~     daily) whereas the other medication is an orally disintegrating medication. Both medications~     are used to treat depressed bipolar patients. The main focus of this study is the comparison~     of these two medications on gastro-intestinal hormones and weight gain.~   "
242170|NCT00384657|"~     Recently, growing body of evidence support the finding that anemia frequently occurs in~     patients with chronic heart failure (CHF). Chronic kidney disease (CKD), as well, is highly~     prevalent among heart failure patients, and both anemia and CKD are independently associated~     with increased mortality. A vicious circle is established with CHF causing both chronic renal~     insufficiency and anemia, and CKD further aggravating anemia which, in turn, worsens CHF and~     so on. Treatment of the anemia breaks this circle and improves the quality of life, cardiac~     and renal functions in patients with severe CHF.~      Intravenous iron alone was proved to allow the maintenance of target hematocrit in one-third~     of chronic renal failure predialysis patients.~      Based on these considerations, intravenous iron for anemia in patients with CHF and moderate~     CKD would represent a reasonable therapeutic approach.~      The aim of the trial is to assess the efficiency of intravenous iron therapy in the~     management of mild to moderate anemia associated with CHF NYHA III class and concomitant~     moderate CKD.~   "
242171|NCT00384644|"~     It is possible to measure skeletal muscle tissue oxygenation (StO2) using near infrared~     spectroscopy(NIRS). It is performed non invasively. We want to compare usually used invasive~     methods for assessing adequacy of flow to StO2 in critically ill. Aim is to faster and non~     invasively estimate adequacy of flow to make therapeutic algorithms efficient.~   "
242172|NCT00384631|"~     Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in~     eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other~     neovascular disorders such as wet-type age-related macular degeneration and diabetic macular~     edema has been described. We aim to evaluate the effect of three intravitreal injections of~     bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures~     include intraocular pressure and extent of iris neovascularization. Both study arms will~     receive conventional treatment for NVG.~   "
242173|NCT00384618|"~     The ATIC study is a randomised, double- blind, placebo-controlled trial in which the effects~     of oxidative stress-lowering treatment on vascular function and structure are studied in~     patients with chronic non-diabetic renal failure who are free from manifest arterial~     occlusive disease. Participants in the trial were randomised to active treatment consisting~     of add-on therapy with pravastatin, vitamin E and homocysteine-lowering therapy, or to~     placebo. Subjects not using angiotensin converting enzyme inhibitors (ACE-inhibitors) or~     angiotensin receptor blockers (ARBs) at inclusion were put on ACE-inhibitors for at least two~     weeks before the baseline measurement and randomisation. Those who were on ARBs continued~     their ARBs. We excluded individuals with diabetes mellitus (ADA criteria), active vasculitis,~     nephrotic syndrome (>3gr/24hr urine protein), renal transplantation, fasting total~     cholesterol > 7 mmol/L, cholesterol-lowering therapy within three months prior to inclusion~     or known ischemic cardiac, cerebrovascular or peripheral arterial disease. Ninety-three~     patients (out of 118 eligible patients) took part in the study and written informed consent~     was obtained from all participants.~   "
242174|NCT00384605|"~     A 1 year worldwide study in obese and overweight patients to assess the safety and effect on~     body weight of an investigational weight loss drug.~   "
242175|NCT00384592|"~     The purpose of this study is to assess how patients with gastro-oesophageal reflux disease~     (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still~     experiencing symptoms will benefit from a change in treatment.~   "
242176|NCT00384579|"~     This study will test the hypothesis that Botulinum toxin B (Myobloc®) treatment reduces pain~     and disability in subjects suffering from acute low back pain due to an identifiable muscle~     strain or back trauma occurring 3 to 6 weeks prior to enrollment. The study will also~     delineate the duration of medication effect and control for any placebo or mechanical~     trigger-point injection effect by employing a prospective, double-blind, placebo-controlled~     design.~   "
242177|NCT00384566|"~     This study looks at the effect of two drugs (carvedilol and metoprolol) which are used for~     patients with CHF (chronic heart failure).~      These agents are beta-blockers and, although effective in heart failure, may cause increases~     in airways tone and thus limit air getting into the lower parts of the lungs. Carvedilol is~     more active at blocking the receptor that opens up the airways and therefore theoretically~     may be more likely to reduce airways tone than metoprolol, although this has never been~     studied in patients with heart failure, and that is the purpose of the present study.~      We are looking to enrol 45 patients with heart failure and mild obstruction to the flow of~     air in their lungs. Patients will be randomised to either carvedilol or metoprolol (standard~     doses). Following a minimum of 2 weeks of therapy of study medication the patient will~     undergo a study day involving an assessment of their lung function, an assessment of their~     heart failure, a living with heart failure questionnaire, blood tests and blood pressure~     and heart rate readings.~      Patients will then be crossed over to the alternate medication. Following 2 weeks on the~     target dose the patient will undergo their second study day which will be the same as the~     first.~      The results obtained from each study day will be compared.~   "
242178|NCT00384553|"~     This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose~     chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or~     refractory aggressive Non- Hodgkins's Lymphoma.~   "
242179|NCT00384540|"~     Primary purpose :To early detect cardiac allograft vasculopathy and to identify patients with~     high risk of cardiac events, by coupling the analysis of the kinetics of the brain~     natriuretic peptide ( BNP) with that of the left ventricle (LV) during a dobutamine stress~     echocardiography.~      Hypothesis : Plasma BNP elevation and abnormalities of LV kinetic during the ESD, will be~     associated with the presence of allograft vasculopathy and the arisen of cardiovascular~     events.~   "
242180|NCT00384527|"~     The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared~     to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).~   "
242194|NCT00384345|"~     Bright light therapy has been used to safely and effectively treat conditions such as~     Seasonal Affective Disorder and to regularize sleep in patients with circadian rhythm~     disorder. Based on evidence of the link between bright light, serotonin, mood and~     carbohydrate metabolism, it has been suggested that bright light therapy can improve weight~     loss but the literature on the subject is sparse. Further, the literature suggests that apart~     from any changes in mood and carbohydrate metabolism, bright light may reduce the unpleasant~     side-effects of exercise and increase compliance to an exercise program.~   "
242181|NCT00384514|"~     Study title:A Study for Testing Safety and Efficacy of the administration of Blood-Borne~     Autologous Endothelial Progenitor Cells to Alleviate Anginal Symptoms and Myocardial Ischemia~     in Patients with Severe Anginal Syndrome~      Principle Investigator: Assoc. Prof. Damras,Tresukosol,M.D.,Head of Cardiac Catherlization~     unit,Division of Cardiology,Department of Medicine,Faculty of Medicine Siriraj~     Hospital,Mahidol University~      Study objective : To determine the safety and efficacy of intracoronary injection of~     blood-borne autologous EPCs in relieving symptoms of angina pectoris in symptomatic patients~     treated with maximal medical therapy with an occluded coronary artery supplying ischemic~     myocardium Study Design : Phase II, a single center,a non-randomized,open-label trial,~      Study population :~      Total expected no. of patients : 24~      main selection criteria :~        -  Patients with chronic stable angina on maximal medical therapy and an occluded coronary~          artery supplying an ischemic viable myocardial region as shown on Sesta-mibi scan. On~          coronary angiography,the occluded coronary artery must have a patent proximal segment of~          at least 30 mm with at least one side branch to enable the injection of the EPC if the~          vessel remains occluded despite the attempted angioplasty efforts.~        -  Age 18-80 years~        -  Ejection fraction >35 % on Sesta-mibi scan~        -  Sestamibi scan (myocardial perfusion) during exercise or dipyridamole,demonstrating~          regional reversible ischemia in an area relating to the occluded coronary artery.~      Investigational Product : At D-8 250 ml of blood drawn from the patients for production of~     autologous EPCs or ACPs (VescellTM), On D0 ,at least 1.5 million EPCs with viability >75 %~     suspended in 6 ml sterile cell culture medium will be injected to the same patients by~     intracoronary artery.~      The study consists of 4 periods:Screening ( D-14to-9&D-8,Treatment(D0),Acute Safety follow-up~     (D1&D2),Chronic follow-up (D30,D90&D180)period ,total follow-up of each case is 6 months.~      Evaluation criteria :~      Safety : no.& duration of adverse event & serious adverse event~      Efficacy :~        -  change from baseline to 1,3,6 months of CCS, 6-minute walking test~        -  change from baseline to 3 & 6 months of Sesta-mibi scan~        -  change from baseline to 3 & 6 months of symptom-limited exercise time,exercise-induced~          ischemia & METs on Sesta-mibi scan Duration of study: July 2004-December 2006~   "
242182|NCT00384501|"~     Purpose To evaluate long-term follow up of Intacs microthin prescription inserts (Addition~     Technology Inc, Fremont, Calif) for the management of keratoconus.~      Design A long-term (five years) retrospective, follow-up study~   "
242183|NCT00384488|"~     The objective for this pilot project is to determine the feasibility and effectiveness of the~     Interactive Voice Response protocol (IVR) on physical activity and eating behaviors in a~     group men and women who have been identified by their physician as being pre-diabetic. We~     hypothesize that participants receiving the IVR follow-up will have greater positive changes~     in their physical activity and eating behaviors when compared to those who receive only the~     standard-care pre-diabetes class.~   "
242184|NCT00384475|"~     The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal~     spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of~     seasonal allergic rhinitis caused by pollen. Ciclesonide will be administered once during the~     exposure to ragweed pollen in a controlled environment. The study duration consists of a~     baseline period (up to 5 days) and a treatment period (1 day). The study will provide further~     data on safety and tolerability of ciclesonide.~   "
242185|NCT00384462|"~     The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization~     rates and to begin to address the utilization of outpatient resources for RSV~     medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age~     (GA) premature infants who are less than 6 months of age and do not receive treatment.~   "
242186|NCT00384449|"~     The primary objective of this protocol is to look at whether Lucentis (ranibizumab) is safe~     and effective when used for macular edema (retinal swelling) due to Eales' disease. The~     secondary objective is to see if macular edema comes back within three months after the last~     dose of study drug is given.~   "
242187|NCT00384436|"~     The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active~     comparator in severely depressed patients~   "
242188|NCT00384423|"~     This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics~     of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's~     Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue~     to experience worsening AD symptoms.~   "
242189|NCT00384410|"~     Sleep disturbance is perhaps one of the most prevalent complaints of patients with~     long-standing painful conditions. Nabilone is a medication that is approved by Health Canada~     as an anti-emetic (prevent vomiting) for patients undergoing chemotherapy. Nabilone, due to~     its sleep promoting properties, is sometimes prescribed by physicians to pain patients to~     help improve their sleep. However, there is no direct research evidence to either support or~     refute this practice. This study will investigate if nabilone is effective in improving sleep~     in insomnia and pain patients.~   "
242190|NCT00384397|"~     This is a Phase III, modified single-blind, randomized, parallel-group, multicenter,~     comparative trial in the United States designed to evaluate the immunogenicity and safety of~     two doses of Menactra vaccine administered alone, and concomitantly with other routine~     pediatric vaccines typically administered between 12 and 15 months of age.~      Primary Objective:~      To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.~      Secondary Objectives:~      Immunogenicity~        -  To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when~          Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.~        -  To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when~          Menactra vaccine is administered alone or concomitantly with PCV vaccine.~      Safety~      - To describe the safety profile within 7 and 30 days of each vaccination, and serious~     adverse events (SAEs) throughout the course of the study.~   "
242191|NCT00384384|"~     Background: 18B Glycyrrhetinic acid (active compound of Licorice) decreases serum potassium~     via enhanced renal potassium loss in healthy individuals and thereby inducing renal sodium~     retention and arterial hypertension.In dialysis patients this mechanism is disturbed and~     compensatory intestinal potassium secretion is enhanced. 18B Glycyrrhetinic acid is an~     inhibitor of 11B Hydroxysteroid dehydrogenase type 1 (11b HSD1). Inhibition of 11 b HSD1~     offers a novel potential therapy to lower intracellular cortisol concentrations and thereby~     enhance insulin sensitivity.~      Hypothesis: Glycyrrhetinic acid decreases serum potassium by enhanced intestinal excretion in~     dialysis patients and increases insulin sensivity by inhibition of 11b HSD~      Methods: double blind, 6 month cross over trial comparing oral 18b Glycyrrhetinic acid with~     placebo in 24 nondiabetic dialysis patients.~      Endpoints: predialytic serum potassium levels, insuline sensitivity assessed by fasting~     glucose and fasting insulin concentrations~   "
242192|NCT00384371|"~     This study will test the hypothesis that Botulinum toxin A (BOTOX®) treatment reduces pain~     and disability in subjects suffering from sub-acute low back pain due to an identifiable~     muscle strain or back trauma occurring 6 to 16 weeks prior to enrollment. The study will also~     delineate the duration of medication effect and control for any placebo or mechanical~     trigger-point injection effect by employing a prospective, double-blind, placebo-controlled~     design.~   "
242197|NCT00384306|"~     The aim of this study is to establish associations between blood and urine markers of bone~     metabolism with histomorphometric changes (changes in the actual bone structure) resulting~     from short term oral prednisolone treatment in patients with COPD (chronic obstructive~     pulmonary disease).~   "
242198|NCT00384293|"~     This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia~     on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess~     the affects of MK0524A on carotid intima media thickening using ultrasound compared to~     patients taking placebo. There will be 12 scheduled clinic visits involving review of medical~     history, physical exam, vital signs, laboratory testing, ultrasound imaging, and~     electrocardiograms.~   "
242199|NCT00384280|"~     An open label, 2-period, sequential study to determine the impact of multiple doses of~     rifampin on single-dose pharmacokinetics of HCV-796~   "
242200|NCT00384267|"~     This study will look at blood samples taken from 300 preterm babies and newborns admitted for~     inpatient care at Hopital Gabriel Toure in Bamako, Mali, and to gather information that will~     help the investigators verify the role of malaria in illness of very small babies. Blood~     samples will be taken from the mothers so that the investigators can find out if they have a~     malaria infection and how their body fights malaria. The investigators will also determine~     whether the mother and newborn baby are infected with the same malaria parasite. The~     information from this study may be used to improve malaria treatment in very small babies.~     Mothers and babies whose blood is tested will receive treatment for malaria as recommended by~     the National Malaria Control Program (NCMP).~   "
242201|NCT00384254|"~     The purpose of the study is to compare two methods for providing brief dental office-based~     interventions designed to help patients quit either cigarette smoking or smokeless tobacco~     use, and to compare these two dental office-based interventions with usual care. This trial~     will evaluate the effectiveness of a unique combination of dental office intervention plus~     referral to the telephone help line, both of which have been demonstrated to be effective~     interventions for tobacco cessation. The integration of two lines of research—dental office~     interventions and telephone help line effectiveness—led us to propose this clinical trial as~     a more efficient and disseminable model of both training and practice.~   "
242202|NCT00384241|"~     High blood pressure affects nearly one third of all individuals in the United States. If left~     untreated, it can lead to stroke, heart failure, heart attack, kidney failure, or blindness.~     For many people, the exact cause of high blood pressure is unknown, but it is believed that~     both genetic and environmental factors contribute to the development of the condition. The~     purpose of this study is to examine the importance of genetics, inflammation, and stress on~     the development of high blood pressure.~   "
242203|NCT00384228|"~     This study will investigate if nilotinib provides an improved safety and efficacy profile~     over that seen in patients receiving Imatinib.~   "
242204|NCT00384215|"~     This trial will explore the various advantages and possible disadvantages of pioglitazone and~     insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid~     profiles, quality of life and cost will be studied given a comprehensive set of data that may~     help future treatment decisions.~   "
242205|NCT00384202|"~     Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based~     immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg)~     basis from a Prograf® based immunosuppressive regimen.~   "
242206|NCT00384189|"~     The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three~     different dose levels compared with placebo with respect to pulmonary function, asthma~     symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment~     medication will be administered as follows: ciclesonide or placebo will be inhaled once daily~     in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period~     (12 weeks). The study provides further data on safety and tolerability of ciclesonide.~   "
242207|NCT00384176|"~     The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in~     treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab)~     in combination with FOLFOX.~   "
242208|NCT00384163|"~     Pulmonary valve replacement in the adult population is an uncommon operation. The majority of~     native valve pathology in adults involves the mitral, aortic, and occasionally tricuspid~     valves. On the other hand, right ventricular outflow tract and pulmonary valve disease is~     quite common in children, especially with tetralogy of fallot, truncus arteriosus, pulmonary~     atresia/ventricular septal defect, and double outlet right ventricle. Unfortunately, right~     ventricular pathology often develops in adulthood as a result of pulmonary insufficiency or~     pulmonary stenosis created by previous childhood operations. Without the valve size~     constraints present at prior operations, these patients can be well-served by the placement~     of adult-sized bioprosthetic valves. There are limited descriptions in the adult cardiac~     literature of the actual technique of pulmonary valve replacement. We present our current~     technique and the pitfalls encountered when performing pulmonary valve replacement in adults.~   "
242209|NCT00384150|"~     This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an~     investigational drug called galiximab in combination with an approved drug called rituximab~     in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study~     114-NH-301 with a time-to-progression >=6 months.~   "
242210|NCT00384137|"~     Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based~     immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg)~     basis from a Prograf® based immunosuppressive regimen.~   "
242211|NCT00384124|"~     -  Double blinded, randomized, placebo controlled trial of imiquimod for the treatment of~          histologically proven Bowens disease of the head and neck.~        -  Null hypothesis: No difference in histologic clearance rates of patients with head or~          neck Bowens treated with imiquimod versus placebo.~        -  Outcome: Histologic clearance of Bowens disease at T=14 weeks.~   "
242212|NCT00384111|"~     This study will treat follicular lymphoma patients who have not received previous treatment~     with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will~     receive only R-CVP. The two patient groups will be compared to determine if Zevalin given~     after R-CVP therapy provides greater benefits than receiving no additional anti-cancer~     therapy after R-CVP.~   "
242213|NCT00384098|"~     Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study~     drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the~     efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque~     psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily~     for 12 weeks.~   "
242214|NCT00384085|"~     The primary objectives were:~        -  To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra®~          (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of~          patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%)~          at Week 60~        -  To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection~          (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from~          Baseline to Week 60 in HbA1c~   "
242215|NCT00384072|"~     The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to~     placebo on bone mineral density after 6 months of therapy in a population of postmenopausal~     Asian women.~   "
242216|NCT00384059|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given~     concomitantly with routine paediatric vaccines in the United Kingdom.~   "
242217|NCT00384046|"~     The purpose of this study is to examine whether the transdermal testosterone system (TTS) is~     effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in~     postmenopausal women who are on transdermal estrogen.~   "
242218|NCT00384033|"~     The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS~     SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.~   "
242219|NCT00384020|"~     The purpose of this study is to understand how genetic polymorphisms influence the efficacy~     and side effect profiles of Paroxetine and Escitalopram for major depression treatment.~   "
242220|NCT00384007|"~     The purpose of this study is to compare a standard surgical procedure, open surgical~     microdiscectomy, used primarily to relieve leg pain and repair disc herniation to a newer~     surgical procedure, hydrodiscectomy with Spinejet®. The study will examine how well each~     procedure reduces subject pain and disability over a one-year period. Magnetic resonance~     imaging (MRI-use of a magnetic field to produce an image) of the lower spinal column taken~     before and after surgery will also be looked at to determine what physical changes have taken~     place over the course of a year. Subjects enrolled in this study will also be asked to keep~     track of their medical expenses related to treating their back pain to see if the surgeries~     being compared reduce out of pocket expenses.~   "
242221|NCT00383994|"~     The goal of this clinical research study is to find out if giving a boost of natural killer~     (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in~     patients who have already received an allogeneic stem cell transplant. The safety of this~     treatment will also be studied. Participants have recurrent chronic lymphocytic leukemia~     (CLL) or lymphoma after non-myeloablative stem cell transplantation.~      Primary Objectives:~      1.0 To determine the safety of Natural Killer (NK) cells and Rituximab +~     rhu-Granulocyte-macrophage colony-stimulating factor (GMCSF) in patients with persistent or~     recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation.~      2.0 To determine factors associated with response.~   "
242222|NCT00383981|"~     To investigate whether exposure to Al, Ga, In, As, and Sb induces lipid peroxidation in~     humans. Whole blood and urine levels of 170 workers were analysed by use of ICP-MS. MDA, the~     product of lipid peroxidation was determined by HPLC~   "
242223|NCT00383968|"~     Prevention of progressive renal disease needs a clear understanding of prevalence of early~     stage of chronic kidney disease in a community. Even in developed countries most subjects in~     early stages of chronic kidney disease go largely undiagnosed and untreated. Targeted~     screening could identify a greater numbers of individuals at risk then a general public~     screening (11). It is economically more feasible to perform in a country like Pakistan.~     Hypertension and diabetes are highly prevalent in South-Asia.It is anticipated that if target~     screening of hypertensive population is performed especially of an age group in which~     intervention might be expected to have maximal benefit it will not only help to identify from~     a large number of patients with essential hypertension destined to develop or in the course~     of advancing towards end stage renal disease but will also unearth mislabeled “essential~     hypertension” that have underlying primary renal disease. This later group may belong to~     socio-economic disadvantaged population who have limited access to health care and have never~     been investigated properly. The aim of the Study is to detect sub-clinical chronic kidney~     disease in hypertensive patients at community level and to identify associated risk factors.~   "
242224|NCT00383955|"~     Coronary artery disease (CAD) is a silent killer that may go undetected for years. It is the~     leading cause of death with no limitation to geographic boundaries accounting to about 16.7~     million deaths world wide. Different studies have shown that South Asians populations are~     more prone to CAD where it is emerging as an epidemic. According to a study conducted in~     Karachi it is estimated that the overall prevalence of cardiovascular diseases in Pakistan is~     26.9% with 23.7% in men and 30.0% in women. However tools for measuring CAD have not being~     adequately validated. This study is designed to develop screening tools and to determine test~     characteristics of Rose Questionnaire and Minnesota Coded ECG alone and in combination for~     diagnosis of CAD, using MPI as gold standard in Pakistan.~   "
242225|NCT00383942|"~     The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs~     extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion~     of patients delivered by cesarean section for fetal intolerance of labor versus vaginal~     delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI~     catheter are less likely to undergo cesarean section for fetal intolerance of labor when~     compared to women who receive misoprostol.~   "
242226|NCT00383929|"~     In this study it is intended to compare the blood pressure lowering effect of the combination~     of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the~     combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in~     patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The~     Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and~     candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.~   "
242232|NCT00383851|"~     This is a multicenter, randomized, phase II study to evaluate the safety and efficacy of oral~     ATN-224 plus temozolomide in patients with advanced melanoma. Patients will be randomized~     (1:1) between temozolomide and ATN-224 and temozolomide followed by ATN-224. Patients~     assigned to the sequential treatment group will receive temozolomide until progression of~     disease is documented and then receive ATN-224 as a single agent until documentation of~     progression of disease using the last tumor assessment on temozolomide therapy as the~     baseline assessment.~   "
242233|NCT00383838|"~     Alcohol use among youth continues to be a major concern for this nation, with a large~     proportion of adolescents increasing their alcohol consumption as they transition from the~     6th to the 8th grade. Although many adolescents experience alcohol-related problems, few~     actually seek help or treatment. This may be because traditional intervention approaches are~     not well suited for this age group. It is important to understand where adolescents turn to~     when they want to get help. The current project focuses on developing an alcohol intervention~     program for younger adolescents. We will conduct biannual surveys at two middle schools to~     assess alcohol and drug use patterns over three years. In years 2 and 3, we will implement an~     intervention in one of the schools.We will examine whether the intervention has an impact on~     subsequent alcohol use.~   "
242234|NCT00383825|"~     To evaluate graft vascularization and compare the vascularization patterns of conjunctival~     autografts with amniotic membrane grafts to better understand the factors involved in~     pterygium recurrence.~   "
242235|NCT00383812|"~     1. Primary objectives~           a. To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal~          vasculopathy(PCV)~        2. Secondary objectives~             1. To assess the changes in visual acuity~             2. To assess the change in lesion characteristics of PCV~                  -  size of PCV~                  -  fluorescein leakage~                  -  foveal thickness~             3. To investigate the safety of intravitreal Bevacizumab in patients with PCV~             4. To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the~               incidence of submacular hemorrhage in patients with PCV~   "
242236|NCT00383799|"~     The purpose of this study is to determine whether intravenous amiodarone has less cardiac~     significant adverse events compared to intravenous procainamide in the acute treatment of~     haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably~     ventricular origen.~   "
242237|NCT00383786|"~     This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the~     effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the~     symptoms of posttraumatic stress disorder (PTSD).~      People between 18 and 65 years of age who have been diagnosed with PTSD may be eligible for~     this study. Participants undergo the following tests and procedures:~      Treatment: Patients are tapered off current ineffective medications over 1 to 2 weeks. All~     participants receive placebo (sugar pill) at the start of the study. At some point within the~     first 3 weeks of the study, they are then randomly assigned either to take GR205171 or to~     continue with placebo for the remainder of the 10-week treatment period.~      Clinic visits: Patients come to the clinic once a week during treatment. The following~     procedures are done at various visits.~        -  Interviews, self report questionnaires and psychiatric rating scales at every visit.~        -  Physical examination, blood and urine tests. Blood is drawn up to 10 times during the~          study.~      Follow-up visits continue for up to 3 months after the end of the study, during which~     patients are offered standard clinical treatment.~   "
242238|NCT00383773|"~     Patients with Central Retinal Vein Occlusion will undergo vitrectomy, a small needle of about~     71 micron will enter a branch retinal vein and TPA will be injected into the obstracted vein.~   "
242239|NCT00383760|"~     This phase II trial is studying how well E7389 works as second-line therapy in treating~     patients with locally advanced, unresectable, or metastatic pancreatic cancer. Drugs used in~     chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing.~   "
242240|NCT00383747|"~     Patients with schizophrenia have a variety cognitive deficits and nicotine has been shown to~     normalize some of these deficits. The purpose of this study is to investigate the effects of~     nicotine on cognition in schizophrenia.We will evaluate the effects of transdermal nicotine~     compared with placebo for attentional impairments in non-smokers with schizophrenia and~     controls.~   "
242241|NCT00383734|"~     Treatment of facial lipoatrophy with dermal injections polylactic acid (Newfill TM) is a safe~     procedure and has been now widely used with a good efficacy. However, this therapy is not~     effective in all treated patients and the benefit of the injections may decrease with time~     necessitating re-injections several months after the first sets of injections. In this study~     we would like to compare the efficacy and safety of Eutrophill(polyacrylamid gel), a~     resorbable filler compound versus Newfill in a comparative, randomised, multicenter trial.~     Primary endpoint will be the self-perception by the patient with a visual analogue scale (VAS~     index). Secondary endpoints are a quality of life questionnaire (MOS-HIV), the a-NBC~     questionnaire (perception by the patient and by the doctor of the severity of the~     lipoatrophy), the measure of the dermal thickness and cheek skin fold as assessed by the~     Skinfold Caliper, the ordering of digital photographs and the evaluation of the dermal~     thickness by CT scan.~   "
242242|NCT00383721|"~     This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study~     evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler~     (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID~     and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic~     obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated~     subjects who will not participate in the safety extension will be discontinued and will have~     their Final Visit at Week 26. Subjects who continue into the 26-week safety extension will~     have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline~     to Week 13 in area under the forced expiratory volume in one second concentration time curve~     from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from Baseline to Week 13 in AM predose FEV1.~   "
242392|NCT00381758|"~     This study was designed to compare Concerta Extended Release tablets with Metadate CD~     capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD~     symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a~     simulated classroom. The treatments were blinded and the effects were compared with a~     Placebo.~   "
242243|NCT00383708|"~     The main aim of this study is to assess the efficacy of the co-administration of lanreotide~     Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant~     (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a~     week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the~     percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the~     end of the co-treatment period.~   "
242244|NCT00383695|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal~     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Giving chemotherapy and radiation therapy with or~     without cetuximab before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed. It is not yet known whether giving oxaliplatin,~     capecitabine, and radiation therapy is more effective with or without cetuximab when given~     before surgery in treating rectal cancer.~      PURPOSE: This randomized phase II trial is studying oxaliplatin, capecitabine, and radiation~     therapy to compare how well they work with or without cetuximab in treating patients~     undergoing surgery for high-risk rectal cancer.~   "
242245|NCT00383682|"~     Persistent pain occurs in 50-85 percent of patients who experience the amputation of an~     extremity. This study will compare the effectiveness of morphine and mexiletine to placebo in~     the treatment of postamputation pain.~      It is hypothesized that the effects of opioids and mexiletine on behavior and mental~     functioning in patients with postamputation pain are unlikely to be significant barriers to~     the clinical use of the drugs.~   "
242246|NCT00383669|"~     This study is a double-blind randomized clinical trial, conducted to examine the effects of~     multivitamins (including B, C, and E) on HIV disease progression among HIV-positive Tanzanian~     adult men and women taking highly active anti-retroviral therapy (HAART).~   "
242247|NCT00383656|"~     The purpose of this study is to explore the effects of synthetic gonadotropin-releasing~     hormone (GnRH) upon the pituitary and ovaries of women with infertility. Women diagnosed with~     GnRH deficiency, hypothalamic amenorrhea or acquired hypogonadic hypogonadism, will~     participate in this study. It is hoped that administration of GnRH will lead to proper~     stimulation of the pituitary gland and to normal ovulation and menstruation.~      **WE ARE CURRENTLY RECRUITING ONLY WOMEN WITH A DIAGNOSIS OF IDIOPATHIC HYPOGONADIC~     HYPOGONADISM (IHH)**~      Pulsatile GnRH has been approved by the FDA for use in women with primary amenorrhea due to~     complete GnRH deficiency. The overall goals of this protocol are to continue to use pulsatile~     GnRH in GnRH-deficient and other anovulatory women for ovulation induction and to examine~     specific physiologic hypotheses, which can only be addressed in this patient population.~   "
242248|NCT00383643|"~     The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate~     (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the~     efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each~     of these two medications with placebos.~   "
242249|NCT00383630|"~     Heart failure is a condition in which the heart is unable to pump enough blood to the body's~     other organs. A heart transplant may be necessary for some individuals with end-stage heart~     failure. Left ventricular assist devices (LVADs) can assist the heart in pumping blood, and~     are commonly used until a donor heart becomes available. Bone marrow cells injected into the~     heart may improve heart function and may lead to earlier LVAD removal. The purpose of this~     study is to evaluate the safety and effectiveness of injected bone marrow cells in improving~     heart function in individuals with LVADs who are awaiting heart transplants.~   "
242250|NCT00383617|"~     The purpose of this study is to determine which of the proposed screening parameters or which~     combination of screening parameters perform best in daily clinical practice for making the~     diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain.~   "
242251|NCT00383604|"~     To better understand the mechanisms leading to lymphedema development in breast cancer~     survivors, and the implications for potential innovative approaches to the screening,~     prevention and treatment of this condition.~   "
242252|NCT00383591|"~     Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed~     primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in~     subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also~     evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.~   "
242253|NCT00383578|"~     This study is designed to demonstrate the efficacy and safety of vildagliptin compared to~     metformin in elderly drug naive patients with type 2 diabetes~   "
242254|NCT00383565|"~     FR901228 may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     to grow and by blocking blood flow to the cancer. This phase II trial is studying how well~     FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.~   "
242255|NCT00383552|"~     This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,~     parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate~     (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind~     Treatment Period, participants will receive open-label (OL) MF MDI 100 mcg twice daily (BID)~     for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by the Area Under the~     Curve from 0 to 12 hours [AUC](0-12 hours) of the change from Baseline to the Week 12~     Endpoint in Forced Expiratory Volume in One Second (FEV1) and by the time-to-first severe~     asthma exacerbation across the 26-week treatment period.~   "
242285|NCT00383162|"~     This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient,~     early-intervention evaluation of subjects who have migraine with or without aura and who~     discontinued use of short acting triptan(s) within the past year due to non-response or~     intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each~     attack; one attack will be treated with one tablet of the Combination Product (sumatriptan~     succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover~     design). [Study 1 of 2]~   "
255488|NCT00206661|"~     The purpose of this study is to observe pediatric Crohn's Disease response to sargramostim in~     patients with or without steroid therapy at two possible dosage levels.~   "
242256|NCT00383539|"~     The primary objective of this trial is to demonstrate the equivalence, in terms of~     immunogenicity, of three different industrial lots of the investigational vaccine thereby~     supporting consistency of the manufacturing process.~      Secondary Objectives:~      Immunogenicity~      To demonstrate that the investigational vaccine induces an immune response at least as good~     as the one induced by the reference vaccine, in terms of antibody titers.~      To assess the immunogenicity of the investigational vaccine using parameters defined in the~     European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).~      Safety:~      To demonstrate that the investigational vaccine is at least as well tolerated as the~     reference vaccine, in terms of defined safety profile.~      To describe the safety profile after vaccination.~      Comfort of the vaccination assessment:~      To assess the pain immediately after the injection using a Verbal Rating Scale. To describe~     the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire:~     the Vaccination Comfort Questionnaire.~   "
242257|NCT00383526|"~     Vaccination against influenza is a high priority for the elderly population who present the~     highest morbidity and mortality rate. However, due to their weak antibody response an~     improvement of the immune response to influenza vaccination remains an unmet medical need.~     The purpose of an investigational influenza vaccine candidate administered by an alternate~     route is to improve immune responses to the vaccine in the elderly population, which could~     provide additional reductions in influenza-associated morbidity and mortality in this~     population.~      Primary Objective:~      To demonstrate that the investigational vaccine induces a better immunogenicity than the~     reference vaccine in terms of seroprotection rate after the first vaccination.~      Secondary Objectives:~      Immunogenicity:~      To describe the antibody persistence induced by both vaccines at 3, 6, and 12 months after~     the first vaccination in a subset of subjects.~      To describe the immunogenicity of the investigational vaccine after each vaccination using~     parameters defined in the European Medicines Agency (EMEA) Note for Guidance~     (CPMP/BWP/214/96) specific to elderly subjects.~      Safety:~      To demonstrate the tolerance of the investigational vaccine after the first vaccination, in~     terms of pre-defined solicited systemic reactions.~      To describe the safety profile after each vaccination. To describe the effect of repetitive~     injections on the safety profile.~   "
242258|NCT00383513|"~     Epratuzumab is an investigational antibody designed to help treat Systemic Lupus~     Erythematosus (SLE). The purpose of the study is to obtain additional long-term information~     regarding the safety and efficacy of continued maintenance-cycle administrations of~     Epratuzumab.~   "
242259|NCT00383500|"~     To compare the effectiveness of usual treatments for lymphedema [massage and elastic~     compression sleeve, instituted at-risk and before the development of swelling (lymphedema)],~     compared to the use of a newly-marketed device, the Flexitouch, which electronically~     simulates the effect of massage upon lymph flow.~   "
242260|NCT00383487|"~     To determine whether, in this patient population, treatment with calcitriol and Naproxen is~     more effective in delaying the growth of prostate cancer than treatment with calcitriol alone~     as seen in historical controls.~   "
242261|NCT00383474|"~     This phase I trial is studying the side effects and best dose of tipifarnib and bortezomib in~     treating patients with acute leukemia or chronic myelogenous leukemia in blast phase.~     Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving tipifarnib together with bortezomib may kill more cancer~     cells.~   "
242262|NCT00383461|"~     RATIONALE: Computer-based stop smoking programs may assist doctors in helping patients stop~     smoking.~      PURPOSE: This randomized clinical trial is studying how well a computer-based stop smoking~     program works in assisting doctors in helping adults stop smoking.~   "
242263|NCT00383448|"~     Hematopoietic stem cell transplantation has proven effective therapy for individuals with~     adrenoleukodystrophy (ALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy~     (GLD, or Krabbe disease). This protocol also considers other inherited metabolic diseases~     such as, but not limited to, GM1 gangliosidosis, Tay Sachs disease, Sanfilippo syndrome or~     Sandhoff disease, I-cell disease (mucolipidosis II).~      For patients with advanced or rapidly progressive disease, the morbidity and mortality with~     transplantation is unacceptably high. Unfortunately, there are no viable alternative~     therapeutic options for these patients; if transplantation is not performed the patients are~     sent home to die. Our group at Minnesota has developed a new protocol incorporating~     transplantation using a reduced intensity conditioning regimen designed to decrease toxicity~     associated with the transplant procedure. This regimen will make use of the drug clofarabine,~     which has lympholytic and immune suppressive properties without the neurologic toxicity~     observed in the related compound, fludarabine, commonly used for transplantation. In~     addition, several agents providing anti-oxidant and anti-inflammatory properties will be used~     to assist in the stabilization of the disease processes. This revised transplant protocol~     will test the following: 1) the ability to achieve engraftment with the reduced intensity~     protocol, 2) the mortality associated with transplant by day 100, 3) patient outcomes, based~     on differential neurologic, neuropsychologic, imaging and biologic evaluations prior to~     transplantation and at designated points after transplantation (day 100, 6 months, 1, 2 and 5~     years). Additional biologic studies will include pharmacokinetics of clofarabine and~     mycophenolate mofetil (MMF). In addition, for patients undergoing lumbar puncture studies,~     cerebrospinal fluid (CSF) will be requested for determinations of biologic parameters.~   "
242264|NCT00383435|"~     This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study~     evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler~     (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID~     and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic~     obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated~      subjects who will not participate in the safety extension will be discontinued~      and will have their Final Visit at Week 26. Subjects who continue into the~      26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by~     the mean change from Baseline to Week 13 in area under the forced expiratory volume in one~     second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from~     Baseline to Week 13 in AM predose FEV1.~   "
242265|NCT00383422|"~     The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone~     mineral density (bone strength).~   "
242286|NCT00383149|"~     The purpose of this clinical research study is to learn if ixabepilone plus cetuximab~     improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic~     cancer compared to historical data. The safety of this combination treatment will also be~     studied.~   "
242393|NCT00381732|"~     This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to~     evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with~     erectile dysfunction.~   "
242266|NCT00383409|"~     Multivitamins (MVi) are broadly used by cancer patients to improve overall health and energy.~     Fatigue is a common symptom in cancer patients including those receiving radiation therapy.~     We conducted a trial of MVi versus placebo in patients with breast cancer (BC) undergoing~     radiation therapy (Rxt) to evaluate if MVi would affect fatigue and quality of life. We~     randomized patients at the beginning of Rxt treatment to either placebo or Centrum Silver®~     (Wyeth-Whitehall laboratory). At the middle of the radiation treatments patients were~     switched from placebo to MVi and vice versa. Patients answered to the EORTC QLQ C-30 quality~     of life (QOL) and Chalder Fatigue Questionnaires at the beginning, the time of switching and~     at the end of Rxt. We found that both groups experienced significant decreases in general and~     physical fatigue at the end of the course of placebo compared to the assessment prior to this~     treatment. We also observed significant improvements in functional and symptoms in the~     patients on placebo. When we compared different groups of patients we also observed~     significantly lower rates of physical and general fatigue in the patients who had just~     finished a course of placebo as compared to patients finishing course of MVi. We conclude~     that MVi do not improve radiation related fatigue, and may in fact have a deleterious effect~     on fatigue and decrease QOL in patients with BC undergoing Rxt.~   "
242267|NCT00383396|"~     To Determine if topical cyclosporine 0.05% BID prevents recurrent inflammation and improves~     comfort in eyes with pterygia.~   "
242268|NCT00383383|"~     Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre-~     /haemodialysis patients aged ≥15 years.~   "
242269|NCT00383370|"~     To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF~     Trap.~   "
242270|NCT00383357|"~     The purpose of this project is to examine the impact of sleeping pills and waking up in the~     middle of the night on walking balance and cognitive function, to identify risk factors for~     falls in older adults. A significant percentage of falls, approximately 33 to 52 percent,~     occur during the nighttime and morning hours when people are normally sleeping; therefore, it~     is possible that sleep and sleeping medication related impairments in balance may contribute~     to this risk.~   "
242271|NCT00383344|"~     The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn~     Disease and recurrence of Crohn disease after having compared results of PET/CT's with~     results of exams routinely performed(colonoscopy and bowel follow through).~   "
242272|NCT00383331|"~     This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine~     Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in~     patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity~     respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is~     reasonable to investigate the most optimal schedule for this combination, and which~     combination is associated with the most anti-tumor activity in the phase II arena.~   "
242273|NCT00383318|"~     The purpose of this study is to compare the demographic, metabolic, and genomic~     characteristics of patients who develop severe hyperbilirubinemia to patients who never~     developed a significant bilirubin level.~   "
242274|NCT00383305|"~     This is a research study of head cooling. Its goal is to determine whether cooling babies'~     heads can reduce or prevent brain damage that may have resulted from temporarily reduced~     oxygen supply to the brain. In this study, half of the babies (selected at random) will have~     a special cooling cap with circulating water placed on their head for 72 hours to lower the~     temperature of their brain. The rest of the baby's body will be maintained at a defined~     temperature by a standard overhead radiant heater. The study protocol includes the taking and~     analysis of blood samples, performance of brain wave tests, imaging of the brain by~     ultrasound, and other tests as clinically indicated. Neurodevelopmental outcome will also be~     assessed at 18 months of age.~   "
242275|NCT00383292|"~     The primary purpose of this study is to determine the objective response rate (complete and~     partial response) for patients who receive LY573636 after one prior systemic treatment for~     unresectable or metastatic melanoma.~   "
242276|NCT00383279|"~     RATIONALE: Finding out which problems affect employment in survivors of gynecologic cancer~     may help in planning cancer treatment and improve the quality of life of future cancer~     survivors.~      PURPOSE: This research study is looking at ways to improve employment in patients who have~     survived cervical cancer, uterine cancer, or ovarian cancer.~   "
242277|NCT00383266|"~     This is a study of an investigational agent, pemetrexed, in combination with a standard~     chemotherapy drug, carboplatin, for treatment of patients with metastatic esophageal cancer.~   "
242278|NCT00383253|"~     Methods study to characterize early indicators of weight loss in people.~   "
242279|NCT00383240|"~     This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,~     parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate~     (F)[MF/F] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week~     double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily~     (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under~     the Curve From 0 to 12 Hours [AUC](0-12 hours) of the Change From Baseline to the Week 12~     Endpoint~      in Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline to Week 12] and~     Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.~   "
242280|NCT00383227|"~     Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre-~     /haemodialysis patients aged ≥15 years~   "
242281|NCT00383214|"~     The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard~     treatments for patients with SLE.~   "
242282|NCT00383201|"~     To clinically evaluate the effect of a new multi-purpose disinfecting solution compared to a~     marketed multi-purpose solution on wettability of soft contact lenses worn for 30 days.~   "
242283|NCT00383188|"~     Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who~     have failed at least 1 DMARD.~   "
242284|NCT00383175|"~     The purpose of this study is to determine whether special reading glasses improve children's~     ability to learn to read.~   "
242312|NCT00382811|"~     The purpose of this project is to see if weekly carboplatin compared with phenoxodiol in~     combination with weekly carboplatin, is effective against late stage ovarian cancer and to~     see what, if any, side-effects of treatment may result.~   "
242287|NCT00383136|"~     The elective(standard of care) treatment of ST - elevation acute myocardial infarction~     (STEMI) currently consists of primary angioplasty with stent implantation during~     administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor.~      Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor with an efficacy on~     platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is~     used, i.e. 25 microg/kg, (platelet aggregation inhibition > 90% 15 minutes after infusion).~     It can therefore be hypothesized that this drug can improve the results of primary~     angioplasty to the same extent as Abciximab.~      The aim of this study is to compare the efficacy, in terms of myocardial reperfusion indices,~     of Abciximab and high dose of Tirofiban in primary angioplasty for STEMI, both in the case of~     treatment before transfer and of treatment in the catheterization laboratory during the~     procedure.~      The reference hypothesis for the study objective is the equivalence or the non-inferiority of~     Tirofiban with respect to Abciximab.~   "
242288|NCT00383123|"~     The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms~     of the immune response elicited and safety with a six month follow-up after first~     vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment~     Act, Sep 2007.~   "
242289|NCT00383110|"~     1. Determine racial/ethnic differences in trust in physicians and mistrust of the health~          care system among veterans with Type 2 Diabetes.~        2. Determine the predictive power of trust in physicians and mistrust of the health care~          system on personal health practices and health outcomes in a prospective cohort of~          veterans with Type 2 Diabetes~   "
242290|NCT00383097|"~     The purpose of this study is to obtain blood (up to 90 ml or 18-teaspoonfuls on one or two~     occasions) to make LMP1- and LMP2-cytotoxic T-lymphocytes and grow them in the laboratory in~     such a way that they are able to attack LMP1- and LMP2-positive cells in the laboratory.~      If we are successful in growing these cells and if we feel they would be helpful to the~     donor, we would then give the cells back to the donor.~      This trial is for patients that have a type of lymph gland cancer called Hodgkin or~     non-Hodgkin lymphoma, or chronic active Epstein Barr virus (EBV) infection, which has come~     back or not gone away after treatment, including the best treatment we know.~      This is a research study using special immune system cells called LMP1- and LMP2-specific~     cytotoxic T lymphocytes (LMP1- and LMP2-CTLs), a new experimental therapy. As in chronic~     active EBV infection, some patients with Hodgkin or non-Hodgkin lymphoma show evidence of~     infection with the virus that causes infectious mononucleosis (EBV) before or at the time of~     their diagnosis of the Lymphoma. EBV is found in the cancer cells of up to half the patients~     with lymphoma, suggesting that it may play a role in causing lymphoma. The cancer cells~     infected by EBV are able to hide from the body's immune system and escape destruction. We~     want to see if special white blood cells, called T cells, that have been trained to kill EBV~     infected cells can survive in the patient's blood and affect EBV-positive cells. In this~     present study we are trying to find out if we can improve this treatment by growing T cells~     that only recognize two of the proteins expressed on lymphoma cells called LMP1 and LMP2.~     These special T cells are called LMP1- and LMP2-specific cytotoxic CTLs.~   "
242291|NCT00383084|"~     The purpose of this study is to determine the effect of 3 months of daily, 30-minute~     lifestyle physical activity on pain and fatigue in inactive adults with fibromyalgia (FM).~   "
242292|NCT00383071|"~     This study will determine how best to use a vaccine for generating high levels of antibodies~     called immune globulins (IVIG) in people, which, in turn, can be collected and used to~     develop a possible treatment for avian influenza (bird flu). Immune globulins are proteins~     made by the body that attack the influenza virus. This study will use an experimental bird~     flu vaccine to stimulate immune globulin production in healthy people. The vaccine is similar~     to the regular influenza vaccine and has been studied in more than 450 people. This study~     will use high doses of the vaccine to generate high antibody levels that can be collected for~     producing the new treatment.~      Healthy adults between 18 and 60 years of age who weigh at least 110 pounds may be eligible~     for this study. Candidates are screened with a medical history and physical examination.~      Participants are given one of three doses of the vaccine, depending on when they enter the~     study. The first 25 people enrolled receive a dose of 90 micrograms (mcg). If this dose is~     well tolerated, the next 25 people receive 120 mcg, and if this dose is also well tolerated,~     the last 25 people receive 180 mcg. Vaccination consists of either two shots (one in the~     muscle of each arm) or one shot in the buttock on four occasions. Subjects are vaccinated on~     four occasions, each 4 weeks apart. On the day of each vaccination, subjects provide a blood~     sample to evaluate blood counts, chemistries, and antibody levels, and to test for HIV,~     hepatitis B and C, syphilis, and antibody against avian flu. For 7 days after each~     vaccination, subjects keep a diary card to record any symptoms, such as pain, fever, muscle~     aches, or others. At the end of the 7 days, they are contacted by study staff to report the~     symptoms.~      In addition to the vaccinations, subjects undergo apheresis to collect IVIG once their blood~     test shows moderately high antibody levels. For this procedure, blood is collected through a~     needle in an arm vein and flows through a catheter (plastic tube) into a machine that~     separates the blood cells from the antibodies and protein. The antibodies and protein are~     collected and the rest of the blood is returned to the body. Subjects are asked to undergo at~     least three apheresis procedures.~   "
242293|NCT00383058|"~     The purpose of this study is to examine whether the extract of the green tea is effective on~     obese women.~   "
242294|NCT00383045|"~     A randomized clinical trial comparing drug abuse and HIV risk reduction counseling (DC-HIV)~     alone, DC-HIV combined with naltrexone maintenance, and DC-HIV combined with buprenorphine~     maintenance for the treatment of heroin addicts in Malaysia.~   "
242295|NCT00383032|"~     Data from other countries have suggested that oral mifepristone used as a cervical ripening~     agent may decrease induction to delivery time in midtrimester inductions. To our knowledge,~     there are no trials comparing mifepristone to laminaria in a standard clinical setting with~     standardized misoprostol induction protocol to examine the issue of induction to delivery~     time. We hypothesize that mifepristone will work at least as well as laminaria for~     midtrimester cervical ripening prior to induction of labor with misoprostol.~   "
242296|NCT00383019|"~     This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in~     Japanese patients with POAG or OH.~   "
242297|NCT00383006|"~     Problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult~     patients with traumatic childhood experiences. The study intends to evaluate the efficiency~     of a 14-week group therapy for adult survivors of relational trauma in childhood. Main~     interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills~     for affect regulation and techniques for activating resources. The hypothesis is that the~     group therapy significantly improves the participant's capacity in emotion management and~     self-soothing.~   "
242394|NCT00381719|"~     This study will explore the safety and effectiveness of different doses of AGN 203818 in~     treating pain in patients with painful diabetic peripheral neuropathy~   "
242298|NCT00382993|"~     This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient,~     early-intervention evaluation of subjects who have migraine with or without aura and who~     discontinued use of short acting triptan(s) within the past year due to non-response or~     intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each~     attack; one attack will be treated with one tablet of the Combination Product (sumatriptan~     succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover~     design). [Study 2 of 2]~   "
242299|NCT00382980|"~     The purpose of this research study is to compare how the body reacts to different strengths~     of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or~     without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much~     antibody is made to the influenza virus hemagglutinin (HA) after subjects receive the H5N1~     vaccine. Three hundred healthy adults aged 18-40 years will participate for approximately 9~     months, which includes screening. Participants will receive 2 doses of vaccine or placebo~     injected 28 days apart. Participants will have blood samples taken up to 7 times and have 8~     scheduled study visits.~   "
242300|NCT00382967|"~     Patients come to their doctor showing possible symptoms of a movement disorder. It is~     possible that these symptoms may get worse over time. There is more than one disease that can~     cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and~     Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because~     the symptoms caused by these illnesses are almost the same. On the other hand the correct~     treatment for Parkinson´s Disease is different from the correct treatment for Essential~     Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can~     affect the way the doctor treats these patients and whether it can affect their quality of~     life directly.~   "
242301|NCT00382954|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) of bortezomib and~     idarubicin given in combination to newly diagnosed AML patients >60 years or relapsed AML~     patients.~      Another purpose of this study is to determine the dose limiting toxicities associated with~     bortezomib in combination with idarubicin in newly diagnosed AML patients >60 years or~     relapsed AML patients.~   "
242302|NCT00382941|"~     The purpose of this study is to determine whether LED phototherapy using combined red and~     near infrared light (approved: Ministry of Health of Russian Federation No.~     29/06070997/1080-00, EUROCAT Certificate No. CP033321-IV) is effective in the treatment of~     musculoligamentous lesions in physiotherapy practice~   "
242303|NCT00382928|"~     We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who~     are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted~     to the telemetry ward, all other treatments being constant including cardiopulmonary~     resuscitation.~      We hypothesize that the automatic, rapid, accurate and specific diagnostic and therapeutic~     technology used in AECDs will further increase the rate of survival in patients with cardiac~     arrest through rapid and automatic defibrillation, independent of operator initiation, as~     compared to standard cardiopulmonary resuscitation initiated by healthcare providers.~   "
242304|NCT00382915|"~     This study will evaluate the differences in smoking behavior, nicotine intake, and nicotine~     boost among people with schizophrenia, bipolar disorder, or no mental illness.~   "
242305|NCT00382902|"~     The objective of the study was to clinically evaluate the safety and effectiveness of a new~     multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact~     lenses.~   "
242306|NCT00382889|"~     The aim of this study is to reveal that inhaled corticosteroid therapy combined with a~     short-acting beta2- agonist given on a symptom driven basis is as effective as traditional~     asthma therapy.~      Thus, three advantages will be achieved:~        1. better compliance with treatment since patients will most likely have to administer the~          treatment less frequently,~        2. maximum pharmacological effect with the least amount of drug and~        3. less economic burden on health care providers.~   "
242307|NCT00382876|"~     The infant car restraint devices are a critical part of infant safety during transportation.~     The crash tolerance and the critical safety features of each seat are well established.~     Infant transportation may be via a car seat or car bed. The effect of the sitting position on~     the airway is a concern in an infant with poor head control. Because of this concern, car~     seat tests during which oxygen saturation is measured, are performed on many low birth weight~     infants before discharge from the nursery. Indeed, a number of deaths have occurred in car~     seats probably related to airway obstruction. The relative effects of position on the~     ventilation need to be established.~      We propose to identify the relative changes in ventilation that are induced by position~     change during sleep. We will collect a broad array of high quality data that will identify~     these changes, and the most likely cause. Specifically, we will we screen 200 infants, with~     each infant assigned to the supine position, the car bed and the car seat. The order of these~     positions will be randomly assigned. Following data will be collected:~        1. Relative changes in ventilation will be assessed by oxygen saturation measurement.~        2. Respiratory movement will be measured in order to define the defect.~        3. Once the data is collected, it will be sent for blind data analysis.~        4. Once the data analysis is complete, the effect of position on ventilation will be~          established.~   "
242308|NCT00382863|"~     The purpose of this study is to determine if patients in the HeartNet Ventricular Support~     System with optimal medical and device therapy arm (Treatment group) show statistically~     significant improvement compared to patients in the optimal medical and device therapy alone~     arm (Control group) after 6 months of follow-up.~   "
242309|NCT00382850|"~     The purpose of this study is to determine whether short- and long-term outcomes are different~     between open and laparoscopic Nissen fundoplication performed in children younger than 2~     years of age.~   "
242310|NCT00382837|"~     Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to~     evaluate safety and long term efficacy in concert with standard SLE treatments~   "
242311|NCT00382824|"~     The clinical syndrome of PSP responds poorly to all available forms of therapy used in~     Parkinson's Disease (PD). Currently, no effective treatment exists. Coenzyme Q10 in high~     doses has been shown to be a beneficial therapy in PD and might possibly be a beneficial~     therapy for PSP. This study will compare the efficacy, safety and tolerability of Coenzyme~     Q10 versus placebo in patients with atypical parkinsonian syndrome, progressive supranuclear~     palsy (PSP).~   "
242313|NCT00382798|"~     This is an adaptive Phase I study to evaluate RO5024048 in the following groups:~        -  Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed~        -  Hepatitis C virus (HCV) genotype 1 infected patients who have failed interferon therapy~          (Part 2- Multiple Ascending Dose Study)-Enrollment Completed~        -  HCV genotype 1-infected patients who are treatment naive, to be dosed in combination~          with PEG-IFN and RBV (Part 3 - Combination Dose Study)-Currently Enrolling~        -  HCV genotype 2-3 infected patients who have previously been treated with interferon but~          who did not respond, to be dosed in combination with PEG-IFN and RBV (Part 3 -~          Combination Dose Study)- Currently enrolling~      The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in~     people infected with hepatitis C virus. The amount of RO5024048 in the blood will be measured~     during the study and the amount of hepatitis C virus in the blood after each dose will also~     be measured.~      During Part 3 of the study, RO5024048 will be given with PEG-IFN and RBV, two drugs currently~     used and approved for the treatment of HCV.~   "
242314|NCT00382785|"~     Purpose: The purpose of this project is to evaluate whether psychosocial outcomes in women~     with breast cancer differ based on the format of online group support. This objective will be~     addressed by the following specific aims:~        1. Specific Aim #1 is to determine if there is a difference in depressive symptoms between~          women with breast cancer assigned to one of two treatment conditions: moderated online~          support or peer-led online support.~           • H1: Women with breast cancer who participate in moderated online support will report~          fewer depressive symptoms than women with breast cancer in peer led online support.~        2. Specific Aim #2 is to determine if there is a difference in perceived social support~          between women with breast cancer who are assigned to one of two treatment conditions:~          moderated online support or peer-led online support.~           • H2: Women with breast cancer who participate in moderated online support will report~          greater perceived social support than women with breast cancer in peer-led online~          support.~        3. Specific Aim #3 is to determine if there is a difference in quality of life in women~          with breast cancer who are assigned to one of two treatment conditions: moderated online~          support or peer-led online support.~             -  H3: Women with breast cancer who participate in moderated online support will~               report better quality of life than women with breast cancer in peer-led online~               support.~      NOTE: Once the study began, it was obvious that we could not prevent anyone from joining a~     support group, if that was her choice. We also could not control if participants joined a~     second online support group or face-to-face group during the study. Therefore, we decided to~     omit a usual care (no support) group. The study was completed with just two groups:~     moderated and peer-support.~   "
242315|NCT00382772|"~     The aim of this this study is to evaluate the lot-to-lot consistency of the liquid~     formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared~     to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered~     concomitantly with a combination childhood vaccine.~   "
242316|NCT00382759|"~     The study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of~     fludarabine and total body irradiation in patients older than 60 years of age~   "
242317|NCT00382746|"~     CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill~     diaries and log their weight daily. The data collected and analyzed by the ES-16 device will~     be correlated with the CHF status data.~   "
242318|NCT00382733|"~     The purpose of this study is to evaluate the effectiveness of oral topotecan and how well the~     chemotherapy is tolerated (any side effects) when it is given in different dose levels. The~     study will also collect information on how the medication is being broken down and absorbed~     in the body and how quality of life is affected during treatment.~   "
242319|NCT00382720|"~     This phase II study addressed the use of docetaxel in combination with oxaliplatin with or~     without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously~     untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part~     I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in~     each arm. The optimal dose was administered in the Part II study. Participants who received~     the optimal dose in each treatment arm in Part I were included in the Part II analysis~     population.~      Primary objective:~        -  To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin~          with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent~          gastric cancer previously untreated with chemotherapy for advanced disease (part II).~      Secondary objectives:~        -  To establish the safety profile.~        -  To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO)~          criteria~        -  To assess the Overall Survival (OS)~   "
242320|NCT00382707|"~     Epileptic disease is characterised by enhanced brain excitability. Low frequency repetitive~     transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal~     epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. It is yet~     possible to evaluate cortical excitability and inhibition with TMS-coupled electromyography~     before and after rTMS sessions ; this could provide clues for basic mechanisms of rTMS~     effects on the epileptic brain. We assume that rTMS decrease brain excitability by improving~     brain inhibition. Such an information could help for treating patients with both~     pharmacological and non-pharmacological methods.~   "
242321|NCT00382694|"~     Multiple myeloma is an incurable malignant disease which evnetuelly will relapse after~     primary treatment. Clonal B-cells have been identified and in theory these cells might be~     sleeping during primary treatment and be responsible for later relapse. Fluarabine has~     documented effect on both resting and dividing cells including B-cells. The protocol aim at~     evaluating safety and toxicity of adding fludarabine to induction chemotherapy with~     cyclophosphamide and dexamethasone before high-dose melphalan with autologous stem cell~     support.~   "
242322|NCT00382681|"~     The objective of the study was to clinically evaluate the safety and effectiveness of a new~     multi-purpose disinfecting solution for soft contact lenses.~   "
242323|NCT00382668|"~     The primary purpose of this study is to evaluate how a person with liver impairment processes~     and reacts to the study drug. Information about any side effects that may occur will also be~     collected.~   "
242324|NCT00382655|"~     The goal of this project is to prevent injuries and diseases among older adults through the~     development and evaluation of a novel emergency medical services (EMS)-based screening~     program to identify preventable injuries and diseases and refer the identified injuries and~     diseases for intervention.~      To prevent injuries and diseases among older adults, this study specifically aims to:~        1. Evaluate the feasibility of an EMS-based primary prevention program that screens older~          adults for need of the influenza and pneumococcal vaccine and for risk of falling during~          emergency medical responses in a rural setting;~        2. Evaluate the outcome of the EMT-implemented screening and education program by~          performing a 14-day telephone follow-up on older adults cared for by EMTs.~      At the conclusion of this award, we will determine if an EMT-implemented primary prevention~     program for older adults is feasible and benefits the community.~   "
242481|NCT00380562|"~     The purpose of this study is to examine the effectiveness of the Experience Corps program in~     preventing or delaying physical disability in older adults, by studying the effects of~     volunteerism on physical, social and cognitive well-being.~   "
242325|NCT00382642|"~     The purpose of this study is to learn whether ondansetron is safe and effective in the~     treatment of alcohol dependence. We also want to learn whether the study drug ondansetron~     combined with Cognitive Behavioral Therapy will assist researchers to determine whether~     having a certain gene is responsible for determining how a person benefits or does not~     benefit from the use of ondansetron for alcohol dependence.~   "
242326|NCT00382629|"~     The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by~     gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple~     sclerosis.~   "
242327|NCT00382616|"~     To determine whether supplementation of omega-3 long-chain polyunsaturated fatty acid~     conjugated to phosphatidylserine rather than triglycerides (fish oil) could affect~     Attention-deficit/hyperactivity disorder symptoms in children.~   "
242328|NCT00382603|"~     The objective of the study was to clinically evaluate the safety and effectiveness of a new~     multi-purpose disinfecting solution for soft contact lenses in patients who experience~     discomfort with their contact lenses.~   "
242329|NCT00382590|"~     Primary Objective:~      1. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces~     longer event free survival time in patients age > or = 60 years with untreated Acute Myeloid~     Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for,~     or not placed on, studies of new agents.~      Secondary Objective:~      1. To evaluate whether pre-treatment methylation/acetylation status in AML/MDS blasts~     predicts response to either therapy or whether the ability of the 5 azacytidine + valproic~     acid combination to induce demethylation or acetylation parallels response.~   "
242330|NCT00382577|"~     The purpose of this study is to evaluate the effects of itopride in patients with heartburn.~   "
242331|NCT00382564|"~     This study will determine the usefulness of magnetic resonance imaging (MRI) for examining~     the heart or blood vessels. MRI uses a magnetic field and radio waves to produce images of~     body tissues and organs. The subject lies on a table that can slide in and out of the scanner~     (a metal cylinder), wearing earplugs to muffle loud noises that occur during the scanning~     process. MRI of the heart and blood vessels, called magnetic resonance angiography (MRA), is~     a developing diagnostic method that permits evaluation of arteries and veins without the use~     of x-rays or invasive catheterization required by conventional angiography.~      People 18 years of age and older with known or suspected atherosclerotic disease may be~     eligible for this study.~      Participants have blood tests and MRA scanning. The MRA takes about 1.5 to 2 hours. During~     part of the scan, a contrast agent may be injected into a vein to brighten the images of the~     heart and blood vessels. Subjects are monitored with an electrocardiogram and are asked to~     hold their breath for about 5 to 20 seconds intermittently during the procedure.~      A CT scan may be done to confirm the MRA findings. CT uses x-rays to produce pictures of the~     heart and blood vessels. The subject lies on a bed during the scan and is given a contrast~     agent through a catheter inserted into a vein. Subjects are asked to hold their breath~     intermittently for about 5 to 20 seconds. A medicine called a beta blocker may be~     administered to slow the heart rate.~   "
242332|NCT00382551|"~     To study the effect of red wine, beer and fruit juice on endothelial function in patients~     with coronary Heart disease.~   "
242333|NCT00382538|"~     Mid-second trimester medical terminations of pregnancy require admission to the hospital for~     the length of time it takes a woman to abort. The current protocol at BMC uses intra-amniotic~     digoxin injection the day prior to admission. The following day, the woman is admitted and~     given sequential doses of misoprostol until delivery occurs. The average length of time~     between the first dose of misoprostol and delivery is 12 hours, requiring most women to stay~     overnight. This is a randomized, placebo-controlled, double-blinded study designed to~     determine whether adding mifepristone significantly reduces the induction interval time (time~     between starting the first misoprostol and delivery) required for a second trimester~     termination.~   "
242334|NCT00382525|"~     To construct a computerized database of national profiles and epidemiological data on~     patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with~     or without cardiac resynchronization therapy), implantable loop recorders and leads used~     within their intended use.~      Clinical variables will be analyzed in relation to device-based data and diagnostics.~   "
242335|NCT00382512|"~     This is a Phase I, randomized, placebo-controlled, single blind, parallel group,~     single-center study designed to evaluate immune responses during and after administration of~     12 weekly SC doses of 1.0 mg/kg efalizumab in subjects with moderate plaque psoriasis.~   "
242336|NCT00382499|"~     The purpose of this study is to evaluate the efficacy of intravenous lidocaine infusion~     administered during general anesthesia in:~        1. Reducing length of hospital stay following total abdominal hysterectomy~        2. Reducing postoperative analgesic requirement following total abdominal hysterectomy.~      Hypothesis:~      The addition of an intraoperative lidocaine infusion to a balanced anesthetic technique will~     result in up to 50% of patients being discharged after postoperative day 2 compared with the~     current 21%. Also, it will result in a 30% reduction in opiod consumption during the first 48~     hours following total abdominal hysterectomy.~      Assumption:~      Patients in the intervention and control groups will be titrated to approximately equal~     analgesia because they will self-administer enough pain-controlling medications to make their~     postoperative pain experience the same.~      Primary outcomes:~        1. Length of hospital stay~        2. Total opioid use at 48 hours postoperatively~      Secondary outcomes. The following data will be collected and analyzed:~        1. Intraoperative data: BIS scores (to control depth of anesthesia); intraoperative serum~          lidocaine levels; intraoperative opioid use~        2. Opioid use in the recovery room~        3. Patient Controlled Analgesia (PCA) morphine requirements postoperatively up to 48 hours~        4. Oral pain controlling medication use up to 48 hours postoperatively if IV PCA~          discontinued before 48 hours~        5. Verbal Analogue Scale (VAS) pain scores in recovery room and during first 2 days~          post-operatively~        6. Incidence of side effects that can be attributed to local anesthetic toxicity~        7. Incidence of nausea and vomiting and anti-emetic use up to 48 hours postoperatively~        8. Time of first flatus and first bowel movement.~   "
242337|NCT00382486|"~     The specific aims of this study is to improve short and long-term patient and graft survival,~     to reduce the incidence and severity of allograft rejection, to reduce the incidence of~     infection and to reduce and/or eventually eliminate the need for long-term immunosuppression.~   "
242338|NCT00382473|"~     The purpose of this study is to compare the effects of an 8-week aerobic training program~     upon fat oxidation in vivo and markers of skeletal muscle mitochondrial content and oxidative~     capacity in sedentary obese subjects with and without type 2 diabetes. We will also~     investigate if mitochondrial content in muscle predicts success of weight loss.~      The specific aims are:~        -  To compare systemic fat oxidation rates;~        -  To measure mitochondrial content in muscle before and after aerobic training;~        -  To determine if decreased mitochondrial content is also associated with decreased~          mitochondrial oxidative capacity;~        -  To measure non-plasma fatty acid oxidation in vivo during submaximal exercise conditions~          both prior and after aerobic training;~        -  To determine whether increases in fat oxidation due to physical activity predict weight~          loss success when a reduced calorie diet is added to a physical activity program.~   "
242339|NCT00382460|"~     The primary purpose of the study was to evaluate 4000 subjects with acute coronary syndrome~     by comparing pravastatin 40 mg to atorvastatin 80 mg to determine if they are clinically~     equivalent, and to evaluate the effectiveness of gatifloxacin therapy in reducing~     cardiovascular events in combination with statin therapy.~   "
242340|NCT00382447|"~     Comparison of the researchers' standard nebulizer and a breath actuated nebulizer to examine~     if breathing medication can be delivered more quickly and as effectively or more effectively~     than the standard nebulizer.~   "
242341|NCT00382434|"~     The Emergency Department (ED) is a unique environment in medicine, and many safety mechanisms~     used in other hospital settings cannot be applied in the ED. For example, clinical~     pharmacists have traditionally provided extra layers of protection to hospital inpatients by~     cross-checking provider orders for appropriate dosing, contraindications, and interactions.~     Because medications in the ED must be accessed immediately and are often one-time doses, the~     use of central pharmacy services would introduce an unacceptable delay to the administration~     of medication. Although some hospitals have programs in place in which a pharmacist responds~     to the ED for cardiac arrests or trauma team activations, few have reported programs which~     involve a clinical pharmacist assigned exclusively to the emergency department. Nonetheless,~     published reports have asserted that ED-based pharmacists can increase patient safety.~     Although this concept appears logical, no study has attempted to show that these programs~     reduce potential adverse drug events in the ED. We propose to implement and optimize an ED~     Pharmacist (EDP) program as a safe practice intervention in a large ED. The hospital has~     provided funding for two permanent full time positions starting at the beginning of the award~     period. In the initial phase interviews of physicians, nurses, pharmacists, and patients will~     be conducted and the results will be used to optimize the EDP role. A large-scale chart~     review study will then be conducted to evaluate whether there is a reduction in frequency of~     potential and adverse drug events during times that the EDP is on duty. Staff perceptions of~     the effectiveness of this program will also be evaluated. The overall goal of this initiative~     is to create an effective EDP program that will decrease the rate of adverse drug events in~     ED patients, and to create a toolkit to facilitate the introduction of similar programs~     into other EDs. This toolkit will include a description of the formal, optimized role of the~     EDP, challenges and solutions in implementation, and evidence to support the efficacy of such~     a program.~   "
242342|NCT00382421|"~     There is a lack of data on the prognostic importance of silent ischemia in totally~     asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on~     a possible benefit of medical therapy in such patients. SWISSI 1 therefore recruits totally~     asymptomatic subjects older than 40 years of age without any history of CAD but one~     cardiovascular risk factor with documented silent ischemia. Participants are randomized to~     open antianginal drug therapy and risk factor control versus only risk factor management and~     followed up for ≥ 10 years.~   "
242343|NCT00382408|"~     This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the~     safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory~     disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.~   "
242344|NCT00382395|"~     Study Objective:~      To establish the substantial equivalence of the SOLX Gold Shunt to commercially available~     aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce~     intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional~     surgical treatments have failed.~   "
242345|NCT00382382|"~     Using a new and more detailed approach to diffusion tensor imaging (DTI) recently developed~     in our lab, the investigators hope to learn more about irregularities in the brain that are~     related to autism. The investigators are especially interested in brain regions that~     contribute to repetitive behaviors in children with autism. Repetitive behaviors include~     stereotyped motor movements (hand-flapping), self-injurious behaviors (head hitting),~     compulsions (lining up toys), insistence on things staying the same, and difficulty with~     change. These behaviors often interfere with learning, can disrupt daily functioning, and can~     lead to other behavioral problems. Two specific aims will be accomplished:~      Aim 1: To examine the integrity of white matter pathways in high functioning autistic~     children. The investigators hypothesize that autism is associated with specific white matter~     abnormalities in the cerebellum and other motor circuits. Additionally, the investigators~     expect to confirm and expand on previous reports of cerebral abnormalities by using newly~     developed DTI methods.~      Aim 2: To determine whether there is a relationship between white matter abnormalities and~     the occurrence of restricted repetitive behaviors in children with autism. The investigators~     hypothesize that differences in the occurrence and type of restricted repetitive behaviors~     between autistic individuals are correlated with specific regional white matter~     abnormalities.~      Results from the proposed experiments should contribute to current knowledge of brain~     abnormalities in autism and their relationship to restricted repetitive behaviors, and may be~     relevant to understanding the mechanisms underlying motor deficits in this disorder.~   "
242346|NCT00382369|"~     Vocal cord paralysis is a common cause of congenital stridor and airway obstruction. In this~     study we plan to identify the genetic locus of the genes in two extended families who suffer~     of the disease.~   "
242347|NCT00382356|"~     The study is to determine the safety and efficacy of Dutasteride in patients who have failed~     Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).~   "
242348|NCT00382343|"~     The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing~     pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36~     months with vesico-ureteral reflux (VUR).~   "
242349|NCT00382330|"~     The purpose of this study is to determine if regular and daily repeated application of the~     ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.~   "
242350|NCT00382317|"~     This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal~     angiography.~   "
255572|NCT00205543|"~     In this study we will examine whether suture repair of the palate, or roof of mouth, has any~     effect on results of palate surgery performed for treatment of obstructive sleep apnea.~   "
242351|NCT00382304|"~     Approximately 24 patients will be entered into this study taking place in Canada. The aim of~     this study is to determine if an investigational drug is absorbed (taken up) in patients with~     C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition~     to current standard antibiotic treatment so that all patients will receive active medication.~     All study related care is provided including doctor visits, physical exams, laboratory tests,~     and study medication. The total length of participation is approximately 7 days.~   "
242352|NCT00382291|"~     This study measures the occurrence of certain side effects linked to antidepressant use and~     evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to~     treat people with obsessive-compulsive disorder.~   "
242353|NCT00382278|"~     It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular~     therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis.~     All the patients have moderate liver disfunction and a waiting time expectancy of liver~     transplantation longer than 12 months due their low MELD score. The ABMMC are labeled with~     99mTc and infused through the hepatic artery. Scintigraphy is performed 2 and 24 hours after~     infusion. Patients are submitted to frequent clinical, laboratorial and image evaluation~     during the follow up period of 12 months.~   "
242354|NCT00382265|"~     Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In~     the US there are over 1.1 million visits annually to Emergency Departments for renal colic.~     The disease is extremely painful, often requiring large amounts of narcotic analgesia, and~     results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy~     or surgical removal of the stone. Currently there are no medical interventions other than~     analgesia which are offered to patients.~      Based on encouraging results from several small European clinical studies, the researchers~     hypothesize that the administration of tamsulosin to patients with symptomatic urolithiasis~     will enhance stone passage, and reduce both the time to recovery and the need for surgical~     intervention or lithotripsy. The researchers will conduct a study by identifying and~     recruiting patients presenting with urolithiasis in the emergency departments of four~     institutions.~      A total of 500 consenting subjects will be randomly assigned to one of two groups:~        1. tamsulosin for a maximum of 28 days;~        2. placebo for a maximum of 28 days.~      In addition, both groups will receive standard analgesic therapy.~      The study team, which will be blinded to treatment status, will monitor each subject's~     clinical progress and outcome. The primary objectives of this study are:~        1. to determine if tamsulosin is effective, and~        2. to evaluate the safety of the therapy.~      Another objective is to identify the most appropriate clinical subgroup(s) for treatment.~      If the therapeutic benefits observed in smaller clinical studies are replicated,~     administration of these medications should produce several benefits, including:~        1. a reduction in time to pain free recovery and hence a more rapid return to employment;~        2. decreased requirements for narcotic analgesia;~        3. less need for urological out-patient clinic follow-up;~        4. decreased need for surgical intervention or lithotripsy; and~        5. substantial cost savings.~      If this therapy is beneficial, it will represent a major advance in the treatment of~     urolithiasis. This objective is a major stated goal of the NIDDK Clinical Urology Program,~     which has a stated mission to improve the treatment of urolithiasis.~      Kidney stones are a major public health issue, and one person in eight will be affected by~     the disease. If the hypothesis is verified, the researchers will provide the first medical~     therapy ever for this disease. This therapy, if effective, will reduce the amount of time a~     patient is off work because of the pain from the disease, and may also reduce the need for~     expensive and time-consuming surgical treatments.~   "
242355|NCT00382252|"~     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor~     cells. Diagnostic procedures, such as PET scan and CT scan, may help doctors measure the~     patient's response to treatment.~      PURPOSE: This clinical trial is studying PET scan and CT scan to see how well they work in~     evaluating response to treatment in patients undergoing radiofrequency ablation for lung~     metastases.~   "
242356|NCT00382239|"~     This study will examine the response of several doses of LY2148568 (exenatide) and assess the~     effect on glucose control and safety and tolerability in Japanese patients with type 2~     diabetes.~   "
242357|NCT00382226|"~     Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in~     combination with adjunctive drugs in fixed or unfixed combinations, will be switched from~     their current therapy to travoprost/timolol fixed combination and either Azopt or placebo~   "
242358|NCT00382213|"~     The purpose of this study is to determine the efficacy of treatment with olmesartan~     medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of~     surrogate markers of vascular inflammation for atherosclerotic disease. Patients will be~     randomized to receive either olmesartan medoxomil or placebo for one year.~   "
242359|NCT00382200|"~     RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the~     growth of myelodysplastic cells, either by killing the cells or by stopping them from~     dividing. Tretinoin and decitabine may help myelodysplastic cells become more like normal~     cells, and to grow and spread more slowly. Giving decitabine together with tretinoin may be~     an effective treatment for myelodysplastic syndromes.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of tretinoin when~     given together with decitabine in treating patients with myelodysplastic syndromes.~   "
242360|NCT00382187|"~     The present study aims to evaluate safety and immunogenicity of two doses, administered three~     weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms~     or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine~     containing 15 micrograms of H5N1 influenza antigen, in adults~   "
242361|NCT00382174|"~     The purpose of this study is to evaluate the safety, tolerability and effectiveness of~     Thymosin Beta 4 administered topically in patients with Pressure Ulcers~   "
242362|NCT00382161|"~     The purpose of the study is to determine the effect of fluvastatin on penile arterial blood~     flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.~   "
242363|NCT00382148|"~     This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control~     (placebo) subjects who have completed their final visit (or early termination visit, if~     applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who~     provide consent to participate in this study.~   "
242364|NCT00382135|"~     This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel~     design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with~     20 mg tadalafil.~   "
242365|NCT00382122|"~     Demographic information and a brief medical and concomitant medicine history will be obtained~     from the glaucoma patient's records. Qualified patients will be asked to complete a~     questionnaire about their symptoms. Patients will then be scheduled to undergo three standard~     clinical tests of the ocular surface.~   "
242390|NCT00381784|"~     One of the objectives of the C2P coalition is the successful delivery of a CDC-endorsed~     community-level HIV prevention program aimed at changing the risk profiles of youth. This~     protocol (ATN 041) describes the program, Community PROMISE (Peers Reaching Out and Modeling~     Intervention Strategies) or MPowerment, and plans for adapting and implementing it. There are~     a total of 4 interventions that a community can implement.~   "
242366|NCT00382109|"~     This randomized phase III trial is studying tacrolimus, methotrexate, and sirolimus to see~     how well they work compared to tacrolimus and methotrexate in preventing graft-versus-host~     disease in young patients who are undergoing donor stem cell transplant for intermediate-risk~     or high-risk acute lymphoblastic leukemia in second complete remission and high risk acute~     lymphoblastic leukemia in first remission. Giving chemotherapy, such as thiotepa and~     cyclophosphamide, and total-body irradiation before a donor stem cell transplant helps stop~     the growth of cancer cells. It also helps stop the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune cells and help~     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     tacrolimus, methotrexate, and sirolimus after the transplant may stop this from happening. It~     is not yet known whether tacrolimus and methotrexate are more effective with or without~     sirolimus in preventing graft-versus-host disease.~   "
242367|NCT00382096|"~     The purpose of this study is to evaluate the efficacy and safety of a fixed combination of~     vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes~   "
242368|NCT00382083|"~     This study will explore the effect of pre-medication with acetaminophen, ibuprofen, and~     topical lidocaine gel (Topicaine) on the perception of discomfort and overall satisfaction~     with the mammography experience.~      The research questions are:~        1. What is the relationship between the use of acetaminophen, ibuprofen, and Topicaine~          prior to screening mammography and the perception of discomfort during the procedure?~        2. What is the relationship between perception of discomfort and overall satisfaction with~          the mammography experience?~        3. What is the relationship between the perception of discomfort and plans for future~          mammograms?~        4. What other factors are associated with the perception of discomfort and satisfaction?~   "
242369|NCT00382070|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is~     not yet known whether letrozole is more effective than a placebo in treating patients with~     hormone receptor-positive breast cancer.~      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works~     compared with a placebo in treating postmenopausal women who have received hormone therapy~     for hormone receptor-positive breast cancer.~   "
242370|NCT00382057|"~     The metabolic syndrome is a medical condition defined by high levels of cholesterol in the~     blood, high blood pressure, central obesity (gain in fat around the region of the stomach),~     and insulin resistance (body responds less well to insulin). This state of impaired insulin~     resistance can lead to type 2 diabetes mellitus, which is one of the most common metabolic~     disorders in the U.S. Numerous studies have shown an inverse relationship between insulin~     resistance and testosterone levels in men, however, causality has not been established. This~     protocol investigates the role of testosterone in modulating insulin sensitivity in insulin~     resistant states such as the metabolic syndrome. The hypothesis is that testosterone~     administration will improve insulin sensitivity.~   "
242371|NCT00382044|"~     The purpose of this study is to audit the effects of changing all hemodialysis patients from~     intravenous to subcutaneous administration of ESA's, to ensure that a cost-saving is achieved~     and that this does not occur at the expense of anemia control. The dose changes will occur~     according to usual clinical care of patients and not along a protocol.~   "
242372|NCT00382031|"~     The purpose of this study is to investigate if zalutumumab in combination with Best~     Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer~   "
242373|NCT00382018|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Measuring blood levels~     of tumor cells may help in learning how well chemotherapy works to kill metastatic breast~     cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are~     high while receiving chemotherapy, it is not yet known whether it is more effective to change~     chemotherapy regimens at that time or wait until disease progression.~      PURPOSE: This randomized phase III trial is studying treatment decision making based on blood~     levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.~   "
242374|NCT00381992|"~     International studies have repeatedly documented a substantial prevalence of sexual risk~     behaviors and high rates of human immunodeficiency virus (HIV) and other sexually transmitted~     infections (STI) ranging from 5%-56% amongst long-distance truck drivers (truckers) living~     in diverse international settings including India, Bangladesh, South Africa, China, Laos and~     Thailand. The prevalence of sexual risk factors and STI/HIV in US drivers is unknown. This~     proposal will provide both qualitative and quantitative data on HIV risk behaviors by~     interviewing and testing truckers working for established long-distance trucking firms, the~     sector which accounts for most of the jobs in the trucking and warehousing industry in the~     United States. The data obtained from this study will be used to inform the development of an~     HIV prevention intervention for long-haul truck drivers.~   "
242375|NCT00381979|"~     The purpose of the study is to investigate the effectiveness of providing Supportive~     Expressive Therapy to adolescents who are depressed and/or anxious.~   "
242376|NCT00381966|"~     This is a study that will try see if a device can help to better guide the needle that places~     prostate cancer treatment.~   "
242377|NCT00381953|"~     The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics~     by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU~     interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of~     treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and~     sustained virological response rate will be assessed by the type of induction.~   "
242391|NCT00381771|"~     It is well known that 'globus sensation in throat' is caused by the chronic irritation and~     inflammation of oral, pharyngeal, or laryngeal mucosa, such as laryngopharyngeal reflux and~     chronic postnasal drip.~      Xerostomia and pharyngoxerosis due to salivary hypofunction also proved to induce the mucosal~     change of the oral cavity and pharynx.~      However, no previous studies have documented the prevalence of salivary hypofunction in~     patients with globus pharyngeus.~      Through this clinical investigation, we hypothesized that the salivary hypofunction might be~     one of the leading cause of globus pharyngeus.~   "
242378|NCT00381940|"~     This phase II trial studies the side effects and efficacy of bortezomib with ifosfamide and~     vinorelbine in children and young adults with Hodgkin's lymphoma that was recurrent or did~     not respond to previous therapy. Bortezomib is an inhibitor of protein degradation.~     Bortezomib degrades short-lived regulatory proteins in the cell, and has been reported to~     increase the tumor cells. Bortezomib may increase the effectiveness of ifosfamide and~     vinorelbine (two standard drugs given to children with Hodgkin Lymphoma that has come back~     after initial treatment) by making cancer cells more sensitive to effectiveness of standard~     chemotherapy by preventing anti-death responses in these drugs. Giving bortezomib together~     with ifosfamide and vinorelbine tartrate should kill more cancer cells than are killed with~     ifosfamide and vinorelbine alone.~   "
242379|NCT00381927|"~     To evaluate 1) the extent of patient overestimation of breast cancer development risk in~     subjects referred to a physician-based high-risk breast clinic; 2) the ability of physician~     counseling to improve patient risk perception and reduce psychological distress; 3) to~     identify factors relevant in clinical practice associated with increased distress and risk~     perception.~   "
242380|NCT00381914|"~     The research team is comprised of an expert nutrition scientist and a pediatrician with~     expertise in endocrinology. Both have world-class experience in assessing bone mass in~     infancy. Together they have designed a study to determine how much dietary vitamin D is~     needed to optimize health in infants. This is important since many infants are born with~     vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is~     unclear and recent research suggests that vitamin D status very early in life has long~     lasting effects on bone mass and other health issues. Therefore, in a group of healthy~     infants, this research team will test which dosage of vitamin D is needed to achieve optimal~     vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D~     and bone status in blood and also general health. The infants will all be breastfed and begin~     the study at about 2 weeks of age. At 3 months intervals over the first year of life, each~     infant will be measured for growth, duration of breastfeeding and supplement use plus have a~     bone density scan to determine changes in bone growth. The data will be helpful to guide~     health care professionals in providing the best care possible for their infants. It will also~     be important to the health of populations since dietary recommendations for vitamin D are~     used to guide fortification of foods and development of evidence based policy around nutrient~     recommendations and their implementation.~   "
242381|NCT00381901|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. It is not yet known whether giving~     trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating~     patients with breast cancer.~      PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works~     when given for 6 months compared to 12 months in treating women with nonmetastatic breast~     cancer that can be removed by surgery.~   "
242382|NCT00381888|"~     RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are~     undergoing surgery for gynecologic cancer.~      PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood~     clots in patients undergoing surgery for gynecologic cancer.~   "
242383|NCT00381875|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response.~     Incomplete Freund's adjuvant may stimulate the immune system in different ways and may help~     the vaccine work better. Colony-stimulating factors, such as GM-CSF, may increase the number~     of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together~     with incomplete Freund's adjuvant and GM-CSF may be an effective treatment for patients with~     HIV.~      PURPOSE: This clinical trial is studying how well giving vaccine therapy together with~     incomplete Freund's adjuvant and GM-CSF works in treating patients with HIV.~   "
242384|NCT00381862|"~     RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and~     vomiting in patients receiving chemotherapy.~      PURPOSE: This phase II trial is studying how well giving aprepitant together with~     palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy~     in patients receiving chemotherapy for metastatic colorectal cancer.~   "
242385|NCT00381849|"~     We will investigate the safety and effectiveness of a mixture of 9 east Indian herbs known as~     Cystone regarding their ability to dissolve existing kidney stones and prevent formation of~     new ones. Cystine and calcium stone formers will be recruited for a 59 week trial. The first~     phase of the study will be two 6 weeks periods during which each subject will receive Cystone~     or placebo in random order (with a one-week wash out between 6 week treatment periods). The~     remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary~     chemistries and stone burden by Computerized Tomography (CT) scanning.~   "
242386|NCT00381836|"~     The purpose of this study is to determine whether or not Aranesp® (Darbepoetin Alfa),~     administered every fourth week, is effective in the treatment of blood shortage (anemia)~     compared to standard care of treatment (blood transfusions) in patients with anemia due to~     hormone refractory prostate cancer.~   "
242387|NCT00381823|"~     The purpose of this study is to determine if an integrated intervention addressing active~     smoking, environmental tobacco smoke exposure, depression and intimate partner violence,~     would improve pregnancy outcome among African American women.~   "
242388|NCT00381810|"~     This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the~     safety and efficacy of rituximab when administered on a scheduled basis every 6 months over~     the course of 1 year with reassessment of response at 12 months. This study is open to~     participants previously enrolled in Genentech Study U2971g only.~   "
242389|NCT00381797|"~     This phase II trial is studying how well giving bevacizumab together with irinotecan works in~     treating young patients with recurrent, progressive, or refractory glioma, medulloblastoma,~     ependymoma, or low grade glioma. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab~     may also stop the growth of glioma by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving bevacizumab together~     with irinotecan may kill more tumor cells.~   "
242395|NCT00381706|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving more than one chemotherapy drug (combination chemotherapy)~     together with cetuximab may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying three different combination chemotherapy~     regimens to compare how well they work when given together with cetuximab in treating~     patients with metastatic esophageal cancer or gastroesophageal junction cancer.~   "
242396|NCT00381693|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop~     the growth of abnormal cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with~     myelofibrosis.~   "
242397|NCT00381680|"~     This randomized phase III trial is studying low-dose vincristine to see how well it works~     compared with high-dose vincristine when given together with different combination~     chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute~     lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Giving more~     than one drug (combination chemotherapy) and giving the drugs in different ways and different~     doses may kill more cancer cells..~   "
242398|NCT00381667|"~     This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine~     GW642444M via the inhaled route and will assess the efficacy, safety, tolerability,~     pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25,~     100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre,~     placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.~      Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will~     be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical~     laboratory safety tests, collection of adverse events and blood samples.~   "
242399|NCT00381654|"~     AV-412 is a new oral therapy developed to inhibit the growth of solid tumors in patients who~     have not responded to standard therapy or surgical interventions, or who have experienced~     relapse. This study will test the safety of AV-412 and determine the maximum tolerated dose~     for the treatment of solid tumors.~   "
242400|NCT00381641|"~     This phase II trial studies how well sunitinib malate works in treating patients with thyroid~     cancer that did not respond to iodine I 131 (radioactive iodine) and cannot be removed by~     surgery. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~   "
242401|NCT00381628|"~     Study Hypothesis: We hypothesize that cellular markers from nasal epithelial cells and blood~     lymphocytes can serve as potential biomarkers reflect the underlying inflammatory state of~     the lung and will be helpful in determining the presence of a CF pulmonary exacerbation and~     its overall severity.~   "
242402|NCT00381615|"~     This study was aimed to explore safety and immunogenicity of two formulations of a~     Meningococcal B Vaccine when administered to healthy infants.~   "
242403|NCT00381602|"~     Malnutrition and altered protein catabolism are serious problems in renal failure and~     hemodialysis (HD) patients. The purpose of this study is to characterize the safety of~     GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG~     in subjects with ESRD on HD by following GH and IGF-1; to describe the relationship between~     GHRP-1 PD and plasma concentrations of GHRP-1 and des-Ala-GHRP-1; and to evaluate the~     preliminary efficacy of GHRP-1/AG on nutritional status of subjects with ESRD on HD using~     subjective global assessment of malnutrition inflammation scores (MIS) and changes in caloric~     intake.~   "
242404|NCT00381589|"~     Hypersalivation (Too much saliva) and drooling is a side effect experienced by 31% of people~     taking the antipsychotic clozapine. This study aims to determine if using the medication~     ipratropium bromide(IPB)at bedtime will reduce the amount of salivation and the distress~     people may feel.~   "
242405|NCT00381576|"~     The purpose of the present investigation is to determine whether MS patients can tolerate and~     benefit from heavy progressive resistance training. A second purpose is to determine both~     neural and muscle morphological adaptations to heavy progressive resistance training.~   "
242406|NCT00381563|"~     Osteoarthritis, sometimes called degenerative joint disease, is the most common form of~     arthritis. It occurs when the cartilage in joints wears down over time. Symptoms can include~     pain, tenderness, stiffness, and inflammation. Studies have suggested that symptoms of knee~     osteoarthritis may be caused by abnormalities at the patellofemoral joint, which is the joint~     between the kneecap, called the patella, and the thigh bone, called the femur. This study~     will determine whether wearing a knee brace that realigns the patella over the femur is~     effective in relieving pain and improving function in adults with knee osteoarthritis.~   "
242407|NCT00381550|"~     This phase II trial is studying how well giving 3-AP together with fludarabine works in~     treating patients with myeloproliferative disorders (MPD), chronic myelomonocytic leukemia~     (CMML), or accelerated phase or blastic phase chronic myelogenous leukemia. Drugs used in~     chemotherapy, such as 3-AP and fludarabine, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. 3-AP may help~     fludarabine work better by making cancer cells more sensitive to the drug. 3-AP and~     fludarabine may also stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth. Giving 3-AP together with fludarabine may kill more cancer cells.~   "
242408|NCT00381537|"~     Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood~     epilepsy in Bangladesh with particular reference to behavioural side effects.~   "
242422|NCT00381329|"~     The Pennsylvania Adolescent Smoking Study (PASStudy) will evaluate the effectiveness of~     Motivational Interviewing (MI) compared to Structured Brief Advice (SBA) to reduce cigarette~     smoking among adolescents who smoke. MI is a brief 5 session client-centered~     psychotherapeutic style intended to increase the probability that a person will enter into,~     continue and adhere to a specific change strategy. This will be compared with SBA, which~     implements Best Practice Guidelines (i.e., 5 A's and 5 R's) and assists participants in~     accessing the best available resources for smoking cessation.~   "
242409|NCT00381524|"~     In the third decade of the HIV pandemic, what was once a uniformly and rapidly fatal disease~     has been transformed into a chronic illness by advances in the understanding of HIV~     pathogenesis and therapeutics. As a result, HIV-infected individuals are living longer and~     better lives. This phenomenon, coupled with a continued steady rate of new HIV infections in~     this country, has led to the highest U.S. HIV prevalence rates since the beginning of the~     epidemic. In the past, HIV prevention efforts were separate from routine primary care~     delivery due to multiple factors including stigma and time constraints. Recent events,~     including increases in sexually transmitted disease (STD) rates among HIV-infected persons~     and evidence that infected individuals can be super-infected by HIV strains resistant to~     antiretroviral therapy, have inspired the SPNS program initiative to develop demonstration~     projects for interventions to reduce risky sexual exposures among HIV-infected patients~     receiving primary care.~   "
242410|NCT00381511|"~     Background. Management of patients with suspected Pulmonary Embolism (PE) is problematic if~     diagnostic imaging is not available. Pretest Clinical Probability (PCP) and D-dimer (D-d)~     assessment were shown to be useful to identify those high risk patients for whom empirical,~     protective anticoagulation is indicated.~      To evaluate whether PCP and D-d assessment, together with the use of low molecular weight~     heparins (LMWHs), allow objective appraisal of PE to be deferred for up to 72 hours, we~     planned to prospectively evaluate consecutive patients with suspected PE.~      Methods. In case of deferment of diagnostic imaging for PE, patients identified at high-risk~     (those with high PCP or moderate PCP and positive D-d), receive a protective full-dose~     treatment of LMWH; the remaining patients will be discharged without anticoagulant. All~     patients will be scheduled to undergo objective tests for PE within 72 hours. Standard~     antithrombotic therapy will be then administered when diagnostic tests confirmed Venous~     ThromboEmbolism (VTE).~   "
242411|NCT00381485|"~     This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy~     of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice~     daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind~     treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during~     the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours~     [AUC](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory~     volume in one second (FEV1).~   "
242412|NCT00381472|"~     The purpose of this double-blind, placebo controlled study is to evaluate the safety and~     effectiveness of an investigational Parkinson's disease drug in patients with advanced~     disease who are not well-controlled on their L-dopa medication.~   "
242413|NCT00381446|"~     The purpose of this study is to quantify the amount of corneal staining observed with various~     marketed contact lens/multipurpose solution combinations. The hypothesis is that there are~     measurable differences in the amount of corneal staining between the various combinations.~   "
242414|NCT00381433|"~     AVI-4020 Injection, a phosphorodiamidate Morpholino oligomer (PMO), was found to cross the~     blood-brain barrier during a study of patients with presumptive West Nile virus disease.~     AVI-4065, which was designed to target HCV, is also a PMO; its ability to cross the~     blood-brain barrier is unknown. In this study, a single dose of AVI-4065 will be~     subcutaneously injected, and samples collected to determine if this drug crosses the~     blood-brain barrier. If it does, then additional investigations could be performed in people~     with severe forms of HCV disease in which the brain is affected.~   "
242415|NCT00381420|"~     The main objective of this study is to assess the safety and effectiveness of the~     sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native~     coronary artery lesions as compared to the uncoated Bx VELOCITY™ balloon-expandable stent.~     Both stents are mounted on the Raptor® Stent Delivery Systems.~      The secondary objective is to assess cost-effectiveness expressed in incremental cost/life~     year gained or cost/quality adjusted life year gained at different time points (8 months, 1~     year, 3 and 5 years).~   "
242416|NCT00381407|"~     This study will evaluate the effectiveness of organizational skills training in improving~     organizational, time management, and planning difficulties in children with attention deficit~     hyperactivity disorder.~   "
242417|NCT00381394|"~     Sitamaquine is an 8-aminoquinoline which is being developed as an oral treatment for visceral~     leishmaniasis (VL). Pre-clinical and subsequent clinical investigations have demonstrated~     oral efficacy against Leishmania donovani. The purposes of this study are to characterise the~     pharmacokinetic profile of sitamaquine, administered orally, and to determine if the~     pharmacokinetic profile is affected by administration with food. The study is also designed~     to further characterise the safety and tolerability of sitamaquine compared with amphotericin~     B, particularly in reference to renal, hepatic and cardiac adverse events, prior to~     initiation of phase III studies. Finally the study will investigate the efficacy of a 21 day~     treatment course. Previous studies have used 28 days dosing, but parasitological evidence~     from one study suggests that shorter courses may be effective.~   "
242418|NCT00381381|"~     This study attempts to differentiate the clinical responses of Choline Acetyltransferase and~     Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.~   "
242419|NCT00381368|"~     The purpose of the study is to determine the efficacy and safety of a three time repeated~     loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients~     with painful skeletal metastases.~   "
242420|NCT00381355|"~     The objective of the proposed large, high-intensity, randomised controlled trial is to~     evaluate the real-life effectiveness of providing a written action plan to asthmatic children~     discharged from the emergency department (ED) or hospital on the short-term adherence to~     written recommendations (including medication, attendance to asthma education and medical~     follow-up). main outcome is adherence to prescribed inhaled preventive medication measured by~     an electronic counter. Secondary outcomes include attendance to asthma education and to~     medical follow-up, serving by pharmacy of prescription of oral steroids, as well as asthma~     control measured by questionnaire (Asthma Quiz for Kidz),2 use of rescue ß2-agonists, relapse~     to emergency room.~   "
242421|NCT00381342|"~     This Phase 3 trial is designed to compare the effects of twice-daily exenatide and~     twice-daily placebo with respect to glycemic control in drug-naive patients with type 2~     diabetes treated with diet and exercise.~   "
242424|NCT00381303|"~     The purpose of this study is to evaluate any differences in the effectiveness, safety, and~     tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg~     twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a~     48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV)~     agents will also be administered and will be chosen by the Investigator based on resistance~     testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).~   "
242425|NCT00381290|"~     The purpose of this study is to compare the effects of a calorie-restricting diet, exercise,~     and a combination of both in reducing knee inflammation and compressive forces in obese and~     overweight adults with knee osteoarthritis (OA).~   "
242426|NCT00381277|"~     The effect of sports drinks on the tendency to form kidney stones has not been assessed.~     Patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes~     in urine chemistry that may decrease the risk of forming stones.~   "
242427|NCT00381264|"~     This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain~     in subjects experiencing pain due to Multiple Sclerosis.~   "
242428|NCT00381251|"~     This study will compare the bioequivalence of two new investigational combination~     formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed~     formulation of Premarin and medroxyprogesterone, Prempro™.~      Prempro is indicated for use after menopause in women with a uterus to reduce moderate to~     severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around~     the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The~     purpose of this study is to determine if these new formulations of Premarin and MPA provide~     the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.~   "
242429|NCT00381238|"~     This is an open-label extension to study 49653/461, to assess the long-term safety of~     rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's~     Disease.~   "
242430|NCT00381225|"~     To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the~     management of head and neck neoplasia.~   "
242431|NCT00381212|"~     To Investigate the safety and immunologic activity of AGS-004, an autologous HIV~     Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART)~     with durable viral suppression.~   "
242432|NCT00381199|"~     Most chronic pain patients with insomnia are currently not well-managed using existing~     medications. If found to safely improve sleep with chronic pain patients, nabilone could be~     added to the treatment options available in the management of fibromyalgia and associated~     symptoms.~      The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as~     efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients~     with fibromyalgia.~   "
242433|NCT00381186|"~     To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on~     general public health recommendations, on glucose tolerance, insulin resistance and metabolic~     cardiovascular risk factors in Dutch subjects with impaired glucose tolerance (IGT).~   "
242434|NCT00381173|"~     The purpose of this study is to evaluate the feasibility, safety, and tolerability of~     administering ZYC300 with Cyclophosphamide (Cytoxan).~   "
242435|NCT00381160|"~     The primary aim of this study is to examine the effect of a multi-component intervention,~     designed to reduce consumption of sugar-sweetened beverages, on weight gain, total energy~     intake, and diet quality in adolescents. The secondary aim is to evaluate whether outcomes of~     the intervention differ between adolescents for whom 100% fruit juice vs. other products~     (i.e., soda, fruit punch, lemonade, iced tea, coffee drinks, energy drinks, sports drinks)~     constitutes the primary source of sugar from beverages.~   "
242436|NCT00381147|"~     We looked for the effectiveness of low-dose long-term prescription of clarithromycin in~     mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans~   "
242437|NCT00381134|"~     Kidney disease affects about one out of three people with diabetes mellitus, a common medical~     problem. Treatment of kidney disease with medications that lower blood pressure can slow the~     kidney disease but there is no known cure. This study is designed to test the hypothesis that~     certain combination-based blood pressure lowering regimens (of FDA approved medications) are~     better than single agent-based regimens for lowering blood pressure and further slowing or~     preventing progression of this incurable disease~   "
242438|NCT00381121|"~     The purpose of the study is to create a Nephrology Tissue Biobank enabling the study of~     kidney disease from the perspectives of epidemiology, genetics and molecular biology.~   "
242439|NCT00381108|"~     To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic~     Hyperplasia.~   "
242440|NCT00381095|"~     The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in~     the adjunctive treatment of subjects with cancer-induced bone pain.~   "
242441|NCT00381082|"~     Objective~      To compare the cure rates (defined as the complete absence of live lice, adults or nymphs, as~     diagnosed by wet-combing of three Australian approved head lice products for the treatment of~     primary school children with head lice infestation. The study design will be randomised and~     assessor-blind using three comparative parallel treatment groups.~      The study population will consist of Queensland state primary school children (up to Year 7)~     with live head lice (adults or nymphs) on the hair or scalp who have not used any head lice~     product in the four weeks prior to the study.~   "
242442|NCT00381069|"~     The purpose of this study is to design, implement, and evaluate a recreation site-based~     obesity prevention & control intervention for 7-9 year old children and their families by~     targeting physical activity and dietary behaviors.~   "
242443|NCT00381056|"~     A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals~     to evaluate the effect of teamwork training on the occurrence of adverse outcomes and~     processes of care in labor and delivery.~   "
242444|NCT00381043|"~     This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol~     problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more~     effective for helping with drinking in a Family Medicine clinic.~   "
242486|NCT00380497|"~     The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the~     standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before~     colonoscopy in children, and to compare effectiveness.~   "
242445|NCT00381030|"~     The purpose of our study was to determine if a strategy of starting a heart medication~     (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager~     would reduce subsequent hospitalizations compared to usual care.~      Hypothesis: A nurse-directed heart failure management program with inpatient initiation of~     beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and~     African American population.~   "
242446|NCT00381017|"~     This is a Phase 3b, randomized, open-label, parallel-group, multi-center, multi-national~     study of low-dose maintenance Peg interferon alpha-2b (Peg-Intron®) in subjects with human~     immunodeficiency virus-hepatitis C virus (HIV-HCV) co-infection. The primary objective is to~     compare at end of study the efficacy of Peg-Intron® monotherapy (0.5 µg/kg subcutaneously~     once weekly for 24-36 months) versus standard supportive care, using the time to any of the~     following clinical events (death, decompensation, liver transplant, hepatocellular carcinoma~     [HCC]) as endpoints.~   "
242447|NCT00381004|"~     The goal of this clinical research study is to learn if using a combination of fludarabine,~     cyclophosphamide, and rituximab, with sargramostim (GM-CSF) can help to control previously~     untreated chronic lymphocytic leukemia (CLL). The safety of this combination will also be~     studied. This study will evaluate antibody-dependent cellular cytotoxicity (ADCC) and its~     relationship to response.~   "
242448|NCT00380991|"~     The purpose of this study is to demonstrate the absence of potential irritation (primary~     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the~     product Dermacyd Delicata (new fragrance of Dermacyd)~   "
242449|NCT00380978|"~     The purpose of this study in nulliparous women undergoing induction of labor is to determine~     whether initiation of neuraxial analgesia compared to systemic opioid analgesia early in~     labor (< 4 cm cervical dilation)affects the cesarean delivery rate.~   "
242450|NCT00380965|"~     This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain~     in subjects experiencing pain due to chemotherapy-induced neuropathic pain in patients with~     cancer.~   "
242451|NCT00380952|"~     This protocol was designed for testing the intraoperative use of the Dune device. This~     multicenter study will take place in Israel at 12 sites.~   "
242452|NCT00380939|"~     This study was designed to assess the effects on coronary artery plaque using aggressive~     lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the~     effect of these treatments on brachial artery vasoactivity.~   "
242453|NCT00380926|"~     Native populations consuming high amounts of fish suffer less from allergic diseases. The~     purpose of this study is to determine whether polyunsaturated fatty acids (fish oil) might~     have a disease modifying influence on asthmatics sensitized to house dust mite.~   "
242454|NCT00380913|"~     This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain~     in subjects experiencing pain due to diabetic peripheral neuropathy.~   "
242455|NCT00380900|"~     The purpose of this study is to evaluate the safety and tolerbility of ascending multiple~     oral doses of AGG-523 in healthy subjects and in subjects with osteoarthritis.~   "
242456|NCT00380887|"~     The purpose of this study is to determine bioequivalence and bioavailability of four~     different Premarin/MPA test formulations versus the current formulation for Prempro.~   "
242457|NCT00380874|"~     Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral~     neuropathy.~   "
242458|NCT00380861|"~     This study will evaluate whether design features of one implant design allows more knee bend~     than the other. Patients will have 1 design in the left knee and 1 design in their right~     knee. Both knee surgeries will be on the same day.~   "
242459|NCT00380848|"~     The purpose of this study is to determine whether hemodiafiltration, a new form of~     hemodialysis can improve sleep apnea in patients with end stage kidney disease.~   "
242460|NCT00380835|"~     The purpose of the study is to evaluate the incidence of cardiac toxicity of amrubicin when~     administered to patients with metastatic breast cancer.~   "
242461|NCT00380822|"~     To investigate the efficacy and safety of miglitol in Japanese patients with type 2 diabetes~     that is insufficiently controlled diet alone.~   "
242462|NCT00380809|"~     The primary purpose of this study is to evaluate the long term effects of the polymer-based~     slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior~     rotablation, in an angiographically well defined group of patients with complex calcified~     coronary lesions.~   "
242463|NCT00380796|"~     The purpose of this long-term observational study is designed to collect additional~     information on incidence of cancer and cause of death among patients who have participated in~     clinical trials of infliximab in the treatment of COPD. Patients must have received at least~     1 dose of study agent (ie, placebo or infliximab) in the primary studies to be eligible for~     participation in this long-term follow-up study. Information on deaths and cancers will be~     collected twice yearly for a period of 5 years from each patient's last safety visit in the~     primary study.~   "
242464|NCT00380783|"~     This study will explore the safety and effectiveness of different doses of AGN 203818 in~     treating the pain associated with painful bladder syndrome/interstitial cystitis~   "
242482|NCT00380549|"~     The primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip~     with BFH technology will lead to lower blood ion levels in patients, as compared to patients~     in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another~     metal-on-metal device. We are also comparing functional and radiographic (x-rays) outcomes~     between patients who receive the CONSERVE® A-Class Total Hip compared to those who have~     received the CONSERVE® Plus Total Resurfacing Hip System.~   "
242483|NCT00380536|"~     This study will evaluate the effectiveness of a medical illness self-management program in~     improving the health and health behavior of people who are receiving care at a community~     mental health center.~   "
242484|NCT00380523|"~     Allow physicians to test the efficacy of arcoxia in patients with acute pain.~   "
242485|NCT00380510|"~     The study examines (1)the incidence of preventive health services provided by family~     physicians to adolescent patients, and (2)barriers and facilitators of prevention discussions~     between family physicians and their adolescent patients.~   "
242487|NCT00380484|"~     The purpose of this study is to assess if treatment with budesonide 200 microgram per day~     affects short- or long term growth in children with asthma~   "
242465|NCT00380770|"~     Kaposi's sarcoma (KS)is the commonest malignancy associated with HIV/AIDS. Therapy for this~     cancer, which causes substantial morbidity, is suboptimal in resource poor settings. The~     reasons for this are: advanced state of immunosuppression when patients present for clinical~     care, concomitant opportunistic infections, non- availability of antiretroviral therapy~     (ART), non-availability and toxicity of chemotherapy (CXT), when available, in patients with~     full blown AIDS, prohibitive costs of bone marrow support and fiscal constraints in resource~     poor settings.~      A recent Cochrane Review assessed the effectiveness of current therapeutic regimens for HIV~     KS, with a focus on options available in resource poor settings. The major selection criteria~     for this review were randomized controlled trials for HIV KS in adults. The main conclusions~     were that data from randomized controlled trials on effective treatments for HIV KS are~     sparse, particularly among people who are also taking highly active antiretroviral therapy~     (HAART). Alitretinoin gel is effective for therapy of cutaneous lesions, pegylated liposomal~     doxorubicin is effective for advanced KS and radiotherapy is effective for treating cutaneous~     lesions. Apart from the randomized trial of radiotherapy, no trials applicable to developing~     settings were identified. Therapy of HIV KS in developing countries thus remains unanswered.~      The authors concluded that therapies discussed in the review are unlikely to be available or~     affordable in developing countries where the bulk of HIV infection and KS occur, apart from~     radiotherapy at a few tertiary centers. However, recent changes in pricing due to the global~     alliance and access initiatives mean that HAART is likely to be more available and accessible~     to developing countries in the near future. South Africa now has committed to this at cabinet~     level and had a task force to address this issue.~      HAART has been proposed as therapy for HIV KS on the basis of restoring immune competence and~     minimizing the HIV tat drive to KS formation. It also improves immunologic control of HHV 8~     possibly through interrupting the HIV-1- HHV-8 interaction.~      There has been only one randomised trial conducted in Spain which compared HAART to the~     combination of HAART and CXT. There is to date no prospective, randomised controlled trial~     which compares the efficacy of HAART to the standard of care in HIV KS in Africa.~   "
242466|NCT00380757|"~     STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR~     quality after 5 minutes of the new 30:2 versus the old 15:2 chest compression to ventilation~     International Resuscitation Guidelines, in a population aged 55 or greater.~      More specifically, we will compare each CPR ratio with regard to:~        1. The achieved frequency and depth of chest compressions,~        2. Participant rating of their perceived level of exertion, and~        3. Resulting serum lactate levels in a subset of the participants.~      STUDY HYPOTHESIS~      In a population aged 55 or greater, the new 30:2 CPR ratio will lead to:~        1. less frequent and shallower chest compressions over the 5-minute study period;~        2. higher rating of perceived level of exertion; and~        3. higher serum lactate levels in a subset of participants when compared to the old 15:2~          CPR ratio.~   "
242467|NCT00380744|"~     The purpose of this study is to examine the safety and efficacy of this antibody in~     rheumatoid arthritis patients.~      Part A of the study is an initial dose escalation phase~      Part B of the study is a randomized allocation of the entire dosing group to parallel~     treatment assignments~   "
242468|NCT00380731|"~     This study will evaluate the effect of cognitive behavioral therapy on the brain during~     emotional and behavioral responses to social stimuli in people with social phobia.~   "
242469|NCT00380718|"~     The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is~     tailored to individual patient tolerance in patients with advanced non-small cell lung cancer~     (NSCLC).~   "
242470|NCT00380705|"~     Allow physicians not familiar with anti-leukotriene based therapy to test it~   "
242471|NCT00380692|"~     The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD~     (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD~     (Autism Spectrum Disorder).~   "
242472|NCT00380679|"~     According to the Advisory Committee on Immunization Practices (ACIP), all people aged 50~     years or older and persons aged less than 50 years who have medical conditions that put them~     at increased risk for serious influenza disease should receive an annual influenza~     vaccination. However, since the mid-1990s, vaccination rates and racial disparities have~     mostly remained static, and there has been limited progress towards the Healthy People 2010~     objectives for influenza vaccination coverage.~      The purpose of this study is to determine what proportion of previously unvaccinated persons~     in target groups for whom influenza and pneumococcal vaccine are recommended will accept and~     receive influenza and/or pneumococcal vaccine in an urban emergency department (ED), and to~     estimate the potential impact of ED vaccination on population-based vaccination coverage. The~     intervention will utilize a combination of assessment survey, vaccine information and~     pre-printed vaccine order sheets.~      The target population for influenza vaccinations includes all patients aged 18 years and~     older for whom influenza vaccine is recommended by the ACIP. This includes all persons aged~     50 years and older and persons aged 18 to 49 years who are in one of the following groups: 1)~     health care workers, 2) pregnant women, 3) residents of long-term care facilities, 4)~     household contacts and out-of-home caregivers of children aged 0 to 23 months, or 5) persons~     with underlying chronic medical conditions which increase their risk of influenza-related~     complications. The target population for pneumococcal vaccination includes all patients aged~     65 years or older who have not previously been vaccinated against pneumococcus or have not~     received the vaccine within 5 years (and were less than 65 years at the time of vaccination).~   "
242473|NCT00380666|"~     The trial evaluates the utility of 18FDG-PET/CT scan in the target definition process when~     SBRT is planned for stage I NSCLC.~   "
242474|NCT00380653|"~     The goal of this study to find the highest tolerable dose of sapacitabine that can be given~     to patients with advanced leukemias or myelodysplastic syndromes.~   "
242475|NCT00380640|"~     The purpose of this study is to assess the efficacy of trimethoprim in promoting wound~     healing and decreasing blister formation in patients with Epidermolysis Bullosa.~   "
242476|NCT00380627|"~     Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.~   "
242477|NCT00380614|"~     Since a proportion of patients with Acute Viral Hepatitis-B develop severe hepatitis and~     fulminant hepatic failure, it is logical to believe that a rapid reduction in the HBV DNA~     levels by using antiviral agents could result in a less intense host response against the~     hepatitis B virus. However, the experience with lamivudine treatment of immunocompetent~     patients with AVH-B is limited.The aim of the present study was to evaluate the efficacy,~     utility and safety of lamivudine in treating immunocompetent patients with AVH-B.~   "
242478|NCT00380601|"~     An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA~   "
242479|NCT00380588|"~     To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine~     alone by comparison in patients with advanced biliary tract cancer~   "
242480|NCT00380575|"~     This study will investigate the application of a vasopressin antagonist in the treatment of~     hyponatremia most likely caused by inappropriate AVP secretion. The population studied will~     include patients with euvolemic or hypervolemic hyponatremia.~   "
242489|NCT00380458|"~     The purpose of this study is to assess whether tonsillectomy and UPPP performed using the~     study device to treat Obstructive Sleep Apnea (OSA) symptoms in adults is associated with~     less postoperative pain during the 21-day postoperative recovery period compared to~     electrocautery dissection.~   "
242490|NCT00380445|"~     Please note this study is not being conducted in the United States. The purpose of this study~     is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and~     muscle metabolism in patients with type 2 diabetes mellitus.~   "
242491|NCT00380419|"~     This study will evaluate the impact of interpersonal psychotherapy on the course of~     depression during and after pregnancy, as well as its effect on infant birth outcomes.~   "
242492|NCT00380406|"~     The purpose of this study is to determine whether gonadotropin releasing hormone agonists~     (medical therapy) will protect against ovarian failure in reproductive aged women undergoing~     sterilizing chemotherapy.~   "
242493|NCT00380393|"~     This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent~     children from falling ill with malaria and to evaluate vaccine safety.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
242494|NCT00380380|"~     Please note this study is not being conducted in the United States. The purpose of this study~     is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal~     glucose levels by delaying gastric emptying.~   "
242495|NCT00380367|"~     The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent~     Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India.~     Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11,~     16, and 18.~   "
242496|NCT00380354|"~     This study will evaluate the efficacy and safety of GSK256066 in the treatment of subjects~     with mild bronchial asthma, using a number of clinical and biological markers of efficacy.~   "
242497|NCT00380341|"~     The purpose of this study is to determine the effects of spinal manipulative therapy on~     autonomic balance and to determine if there exists a relationship between autonomic state and~     postural control.~   "
242498|NCT00380328|"~     To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole~     when co-administered.~   "
242499|NCT00380315|"~     This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy~     as an anti-tussive agent in cough patients.~   "
242500|NCT00380302|"~     Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in~     patients with Alzheimer's disease that is not too severe. There is also evaluation of whether~     patients who take the study medication improve compared to patients who take a placebo (sugar~     pill).~      Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in~     patients who join the study.~   "
242501|NCT00380289|"~     Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide~     diuretics or beta blockers or combination of the two?~   "
242502|NCT00380276|"~     Open-label treatment with MPC-7869 for participants in a previous randomized study.~   "
242503|NCT00380263|"~     To investigate headache score and accompanying symptoms during and after infusion of PACAP38~     i migraine patients~   "
242504|NCT00380250|"~     The primary purpose of this study is to evaluate the efficacy and safety of administration of~     lubiprostone in patients with irritable bowel syndrome with constipation.~   "
242505|NCT00380237|"~     Avian influenza (AI), also known as bird flu, has become a major public health concern in~     many regions of the world. The purpose of this study is to evaluate the safety of and immune~     response to an AI vaccine in healthy adults.~   "
242506|NCT00380224|"~     This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine),~     with respect to the affect on weight during the treatment of outpatients with schizophrenia.~     The study will compare the effect of these medications on several variables, including body~     weight and triglyceride levels.~   "
242507|NCT00380211|"~     The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of~     FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be~     compared to a standard immune response criteria, for both young and elderly populations.~   "
242508|NCT00380198|"~     The purpose of this clinical research study is to compare Apadenoson and adenosine to~     treadmill exercise stress SPECT MPI~   "
242509|NCT00380185|"~     Atherosclerosis, a condition in which fatty deposits build up along the inner walls of~     arteries, can occur throughout the body. The purpose of this study is to examine the possible~     genetic differences that may influence where atherosclerosis occurs.~   "
242510|NCT00380172|"~     The purpose of these studies are to evaluate the effect on vision in subjects with AMD who~     received active and placebo treatment in the MIRA-1 study.~   "
242511|NCT00380159|"~     To assess the safety of 48 weeks of treatment with 10 mg of elvucitabine in combination with~     background ART in subjects who completed protocol ACH443-014A and meet the inclusion and~     exclusion criteria.~   "
242512|NCT00380146|"~     The main purpose of this study is to compare the drug levels of sulfadoxine-pyrimethamine~     found when given to pregnant women for the prevention of malaria to those found in pregnant~     women given the same drug with artesunate for the treatment of malaria, and also with those~     drug levels found in non-pregnant women in other malaria treatment studies.~   "
242513|NCT00380133|"~     This study will assess the effects of single oral doses of SB681323 and prednisolone on~     biomarkers in induced sputum and blood COPD patients~   "
242514|NCT00380120|"~     Prospective controlled randomized clinical trial. Consecutive patients with acute proximal~     deep vein thrombosis (DVT) of the lower extremities, with or without contemporary~     manifestations of pulmonary embolism, are randomized to receive either a fixed duration of~     anticoagulant therapy (three months in patients with DVT secondary to transitory risk~     factors, six months in patients with idiopathic DVT) or a flexible duration of anticoagulant~     therapy, according to the persistence of residual thrombi, as shown by leg veins~     ultrasonography (up to 1 year in patients with secondary DVT, up to 2 years in those with~     idiopathic DVT). All patients are followed up to three years to assess the development of~     (objectively documented) recurrent thromboembolism. The rate of recurrent thromboembolism is~     compared between the two study groups, as well as the rate of major bleeding complications~     occurring during anticoagulation.~   "
242515|NCT00380107|"~     It is the purpose of the researchers to identify the variation in intravascular deficits~     which can have relevance in high risk patients for minor and medium sized surgery.~      The investigators will also estimate fluid deficit in healthy, non-fasting subjects for~     comparison.~   "
242516|NCT00380094|"~     Study of diagnostic tests for heart attack for patients with chest pain.~   "
242517|NCT00380081|"~     The purpose of this study is to evaluate sleep onset following administration of Transcept~     zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.~   "
242518|NCT00380068|"~     The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in~     a broad population of participants with pulmonary hypertension (PH). Secondary objectives of~     this study were to evaluate the effects of ambrisentan on other clinical measures of~     pulmonary arterial hypertension (PAH), long-term treatment success, and survival.~   "
242519|NCT00380055|"~     The purpose of this demonstration is to evaluate the effectiveness of using community~     outreach workers (navigators) to help American Indians living in rural areas overcome~     barriers to appropriate cancer screening, diagnosis, and treatment.~   "
242520|NCT00380042|"~     The purpose of this study is to assess the safety and effectiveness of cortical stimulation~     to the cerebral cortex of subjects who have suffered from treatment-resistant depression and~     have failed routine attempts at controlling their depression.~   "
242521|NCT00380029|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed. Giving erlotinib after surgery may kill~     any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well erlotinib works when given before and after~     surgery in treating patients with muscle-invasive bladder cancer.~   "
242522|NCT00380016|"~     This study offers catheter-based treatment of heart or artery disease. This protocol permits~     treatment of patients with cardiovascular diseases who may not be eligible to participate in~     current research protocols. The treatment offered in this protocol is not experimental, but~     rather standard treatment provided in most large referral hospitals in the United States.~      Patients 18 years of age and older who are candidates for catheter-based treatment of~     obstructive artery disease, including blocked blood flow in a coronary artery (artery to the~     heart) or in an artery of the arm, leg, brain or kidney may be eligible for this study.~     Candidates are screened with a general medical evaluation that may include blood tests,~     magnetic resonance imaging, and monitoring of heart rate and rhythm.~      Participants undergo angioplasty or stenting for blockage in an artery to the heart or an~     artery of the arm, leg, brain or kidney. The procedure uses a balloon-tipped catheter to open~     the blocked artery and likely requires permanent implantation of a metal tube (stent) to~     improve blood flow through the vessel. During the procedure, the patient is given a sedative~     and pain medication, if needed.~   "
242523|NCT00380003|"~     The purpose of this study is to determine whether a compound known as EVT 201 is effective in~     treating people diagnosed with primary insomnia ( difficulty sleeping with no other~     significant contributing factor, such as depression).~   "
242524|NCT00379990|"~     This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis~     patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the~     results from a previous study), prednisolone (7.5mg) or placebo.~   "
242525|NCT00379977|"~     This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus~     acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4~     and 5 months of age.~   "
242526|NCT00379964|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem~     sodium as initial therapy for the treatment of complicated urinary tract infections,~     including pyelonephritis in indian adults.~   "
242527|NCT00379951|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem~     sodium as initial therapy for the treatment of complicated urinary tract infections,~     including pyelonephritis in indian adults.~   "
242528|NCT00379938|"~     This study investigates the safety and effectiveness of a preventative vaccine for parvovirus~     B-19 infection. Eighty-nine healthy adults ages 18-49, whose blood tests negative for B-19,~     will be enrolled. Participants will be randomly chosen to receive 1 of 4 possible vaccine~     types: low dose of the vaccine and an adjuvant (substance which assists with transfer of~     medication to body); high dose of the vaccine alone; high dose of the vaccine and an~     adjuvant; or saline (substance containing no medication). Participants will receive 3~     vaccinations over a 6 month period and will be followed for 6 additional months. Blood~     samples will be taken at months 1, 2, 6, 7 and 12 to determine if antibody, protein produced~     by the body's immune system that recognizes and helps fight infections, has been formed to~     the vaccine. These tests measure vaccine efficacy, i.e., determine if the vaccine induces~     immunity. All participants will be followed closely for safety throughout the study.~   "
242529|NCT00379925|"~     Obese African Americans are at risk for diseases such as diabetes, cancer, and heart disease.~     Church-based interventions have the potential to positively influence the health habits and~     behaviors of a large percentage of African Americans. The purpose of this study is to~     evaluate the effectiveness of a church-based program that emphasizes increased physical~     activity and healthy dietary habits among members of predominately African American churches~     in South Carolina.~   "
242530|NCT00379912|"~     This trial is designed to explore a modified dose and schedule of azacitidine in order to~     more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS),~     i.e., to alter the natural history of the disease without excessive toxicity or burden. The~     administration of erythropoietin is designed to influence the differentiation of primitive~     hematopoietic cells in which azacitidine has reversed the abnormal phenotype to red blood~     cells for patients in whom inadequate production of red blood cells is the major clinical~     issue.~   "
242531|NCT00379899|"~     The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates~     the progression of vascular calcification over one year, compared with a treatment regimen~     that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with~     chronic kidney disease receiving hemodialysis~   "
242532|NCT00379886|"~     Electroconvulsive therapy is the most effective treatment in severe depression and the effect~     is related to the generalized seizure induced by the treatment. General anesthesia is used~     during the treatment. Since only a brief period of unconsciousness is required anesthetics~     with a rapid recovery profile are used.~      Methohexital, a barbiturat, is internationally considered the golden standard, bot other~     short-acting anesthetics are used. In Denmark the most frequent used anestheticum for ECT is~     Thiopental, a barbiturat, but also Propofol, a non-barbiturat, is used in many psychiatric~     departments.~      Several studies have shown that Propofol reduce seizure duration in comparison with~     barbiturates. So far, no studies have demonstrated any clinical implications of the reduced~     seiziure duration. However, these studies have included rather few patiens, most have been~     retrospective, and in the only prospective study conducted, uni-lateral ECT was used.~      The aim of this study is to compare the clinical effect of ECT in patients anesthesized with~     either Propofol or Thiopental. The hypothesis is that the shorter duration of seizures found~     with Propofol as anestheticum will increase the number of treatments needed to clinial~     respons. Furthermore we want to study differences in EEG-relate parameters previously shown~     to have prognostic value. Hospitalized patients with major depression, who is to be treated~     with ECT, are randomized to anesthizia with either Thiopental or Propofol. They are rated~     with Hamilton depression scale and BDI before treatment, after six treatments and when~     treatment is concluded. When treatment is ended the patients are furthermore rated with MMSE~     to evaluate their degree of cognitive impairment.~   "
242533|NCT00379873|"~     This research is designed to study the effects of chiropractic adjustment on the~     physiological responses (EEG, EMG, HRV, skin temperature, and respiration) of college student~     and faculty population.~   "
242534|NCT00379860|"~     To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.~   "
242535|NCT00379847|"~     This study will investigate the application of a vasopressin antagonist in the treatment of~     hyponatremia most likely caused by inappropriate AVP secretion. The population studied will~     include patients with euvolemic or hypervolemic hyponatremia.~   "
242536|NCT00379834|"~     To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with~     Cosopt~   "
242537|NCT00379821|"~     Malaria is a sickness caused by a germ that can get into a person's body when a mosquito~     bites them. It can cause fever, headache, body aches and weakness. It can even cause death,~     especially in children. When malaria is treated with the appropriate medicine(s), it can be~     cured completely. The purpose of this study is to find out if it is better to use chloroquine~     alone or in combination with another drug to most effectively treat malaria. About 640~     children with malaria, aged 6 months to 5 years of age, from the Blantyre Malaria Project~     Research Clinic at the Ndirande Health Center in Malawi will be in the study. They will be~     treated with either chloroquine alone or a combination of chloroquine plus another medication~     (azithromycin or artesunate or atovaquone-proguanil) every time they get malaria for a year.~     Blood samples will be collected and tested at least every 4 weeks. Participants will be~     involved in the study for 1 year.~   "
242538|NCT00379808|"~     The purpose of this study is to determine whether a particular substance involved in~     inflammation, called leukotrienes, is involved in causing heart disease to occur or to~     progress.~   "
242539|NCT00379795|"~     This was an open-label, multicenter, extension study of intravitreally administered~     ranibizumab in two cohorts. The first cohort (reported here) enrolled patients with primary~     or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration~     (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g~     (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort enrolled~     patients with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the~     6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored~     study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). The results of the second cohort~     are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of~     patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14~     days of completion of the 24 month treatment phase of the previous study.~   "
242540|NCT00379782|"~     This Cancer Prevention and Treatment Demonstration Project funded by the Centers of Medicare~     and Medicaid Services awarded six sites across the United States to develop Patient Navigator~     Programs to eliminate disparities in the rate of preventative cancer screening and timely~     diagnosis and treatment of cancer for racial and ethnic minorities. This site of Molokai~     General Hospital are focused on Pacific Islanders and Asian Americans. This program called~     Kukui Ahi propose to increase screening and early detection for four targeted cancers-breast,~     cervical, colorectal, and prostate- with lung cancer additionally being included in treatment~     protocols to improve outcomes and satisfaction by employing a culturally appropriate~     navigation protocol to facilitate utilization of healthcare services and decrease health~     barriers.~      The specific aims of the project is to:~        1. Determine if a Navigator Program can reduce the proportion of the targeted cancers~          diagnosed at a late stage,~        2. Determine if the Navigator Program can improve the continuity of health care for cancer~          patients,~        3. Determine if the Navigator Program can improve quality of life and subjective well being~          of navigated cancer patients,~        4. Determine if the Navigator Program is a cost-effective way to reduce cancer care~          disparities for screenable cancers.~   "
242541|NCT00379769|"~     This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week~     run-in period will be followed by a median of 6 years of treatment with study medication in~     addition to continuation of background glucose lowering therapy. Patients inadequately~     controlled on background metformin will be randomised to receive, in addition to metformin,~     either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio~     of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in~     addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of~     patients receiving background metformin and SU at entry will be entered into the study.~   "
242570|NCT00379392|"~     The primary aim of the proposed study is to collect data in an effort to estimate the~     clinical effectiveness of implementing repetitive task practice (RTP) in addition to mental~     imagery training (MIT) to improve upper extremity motor function and the quality of life of~     chronic stroke patients.~   "
242542|NCT00379756|"~     This is a study consisting of four periods (screening, run-in, treatment, follow-up). A~     four-week treatment-free, run-in period where the subject will make at least four attempts at~     intercourse on four separate days with at least 50% of the attempts must be unsuccessful.~     During run-in the subjects will be using a stopwatch to measure the time from erection~     perceived hard enough for penetration until withdrawal from the partner's vagina. Next there~     are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to~     visit the clinic on 5 occasions over a period of 4 months.~   "
242543|NCT00379743|"~     The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6~     sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ,~     Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration (September~     15, 2006 to September 30, 2010). One goal of the demonstration is to reduce disparities in~     cancer screening among seniors from U.S. racial and ethnic minority populations. Each site~     will focus on a specific racial/ethnic minority group, and collaborate with CMS in project~     implementation. A Core questionnaire, the Cancer Screening Assessment (CSA) will be~     administered at baseline to all participants in the demonstration. Participant~     identification, randomization, and intervention implementation will be standardized across~     sites.~      Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in~     collaboration with the Baltimore City Community Health Coalition is designed to address~     persistent disparities in screening for breast, cervix, colon/rectum and prostate cancer~     among Baltimore City's seniors.~      Primary Objective: Conduct a randomized controlled trial (target N = 2,874) within a project,~     to compare the efficacy of 2 interventions that differ in intensity to improve continuity and~     outcomes of care among African Americans seniors.~      Among African American seniors, compared to a less intensive intervention (general~     information and educational materials), does the addition of facilitation services delivered~     by a health coordinator result in a greater improvement in adherence to cancer screening~     recommendations among those who are not known to have cancer?~      Study Population: We will recruit African American residents of Baltimore, age 65 years or~     older, and currently enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors~     represent 13% of its population, and account for 68% of the City's cancer deaths. Among these~     seniors, 96% have Medicare Parts A and B, 54.5% have income levels at less than 250% of the~     federal poverty guideline, and 55.6% are African American.)~      Eligible participants will respond to a baseline questionnaire, Cancer Screening Assessment~     (CSA). They will then be randomized to receive a less intensive or more intensive~     intervention. The less intensive group will receive general information about cancer and~     Medicare covered services, and instructions to discuss the information with their primary~     care doctor. The more intensive group will receive the same information as the less intensive~     group receives, plus tailored facilitation services delivered by a nurse-supervised community~     health worker. The primary outcome variable will be the difference between randomized groups~     in adherence to screening for breast, cervix, colon/rectum and prostate cancer.~      A community advisory committee will guide all aspects of the study and will include important~     stake holders (both public and private sectors), representatives from the Baltimore City~     Community Health Coalition, the Baltimore City Department of Health, the Maryland Department~     of Health and Mental Hygiene, community leaders, consumers, health care providers~     (physicians, oncologists, nurse practitioners, physician assistants, nurses, social workers,~     pathologists) and academicians.~   "
242544|NCT00379730|"~     Prednisolone will be used as a model medication to identify new clinical outcomes for future~     evaluation of new therapies in short-term studies (up to 4 weeks) in patients with Chronic~     Obstructive Pulmonary Disease (COPD).~   "
242545|NCT00379717|"~     This non-randomized Phase I/II study is designed to determine the maximum tolerated dose~     (MTD) of thoracic radiotherapy and concurrent chemotherapy with cisplatin and docetaxel in~     patients with LA-NSCLC. All patients will receive weekly administrations of docetaxel 20~     mg/m² and cisplatin 20 mg/m2 concurrently with radiotherapy. Radiotherapy will be delivered~     using helical tomotherapy in 30 daily fractions over six weeks. Patients should have~     recovered fully from induction concurrent chemoradiotherapy before they continue with the~     consolidation chemotherapy phase. Patients will be entered in cohorts of at least 5 subjects.~      The first cohort of patients will receive 30 fractions of 2Gy in six weeks up to a total dose~     of 60Gy. The concurrent chemotherapy starts at day 1 of the radiotherapy and will be~     administered 2-4 hours before the radiotherapy.~      The radiotherapy fraction size will be escalated to 2.36Gy in three steps.~   "
242546|NCT00379704|"~     Tissue factor is the main activator of coagulation cascades. Excessive tissue factor~     expression is made responsible of thrombosis in a number of clinical situations including~     thrombosis in contact with atherosclerotic plaques. Recent work showed that tissue factor~     gene expression in adipose tissue was significantly increased in obese versus lean mice.~      The main objective of this study is to show that tissue factor expression is increased in~     human adipose tissue obtained from obese subjects and to identify its main tissular origin by~     comparing abdominal and subcutaneous adipose tissue.~      The secondary objectives are to identify the cell origin of tissue factor (adipocytes versus~     stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue~     factor expressed by adipose tissue, (ii) the amount of subcutaneous and profound adipose~     tissue, and (iii) coagulation activation markers.~   "
242547|NCT00379691|"~     The purpose of this study is to determine the minimum effective bolus dose of phenylephrine~     to prevent post-spinal hypotension in Cesarean section in 95 % of our patients. An adequate~     response will be defined as the absence of hypotension or nausea/vomiting during the period~     from induction of spinal anesthesia to uterine incision prior to fetal delivery.~   "
242548|NCT00379678|"~     THe study seeks to determine if pimecrolimus has a positive effect on increasing~     antimicrobial peptide expression and reducing vaccinia virus growth in the skin explants from~     patients with atopic dermatitis.~   "
242549|NCT00379665|"~     This study is being conducted in order to determine if intratumoral chemotherapy will be~     helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial~     brachytherapy.~   "
242550|NCT00379652|"~     Hypertension and diabetes are among the most common chronic diseases in the United States.~     Racial and ethnic minority groups are more at risk for these diseases than the Caucasian~     population. This study will attempt to identify factors that contribute to racial and ethnic~     differences in hypertension and diabetes care among minority patients of community health~     centers (CHCs). This information will be used to design and implement programs to improve~     quality of care in these communities.~   "
242551|NCT00379639|"~     This was a phase I dose escalation trial designed to determine the maximum tolerated dose~     (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was~     originally planned as a Phase I/II; however only Phase I of the study was conducted.~   "
242552|NCT00379626|"~     The aim of this study is to determine if Cognitive treatment and hormone treatment can change~     the relapse rate of sexual offenders.~   "
242553|NCT00379613|"~     The purpose of this study is to determine the optimal dose of sugammadex when this compound~     is administered during deep neuromuscular block. Sugammadex is administered shortly (5~     minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent~     rocuronium . Under these circumstance the neuromuscular block is deep. The safety and~     pharmacokinetics of sugammadex are also studied.~   "
242554|NCT00379600|"~     To assess whether the anti-inflammatory effects of rosiglitazone result in improvements in~     Rheumatoid Arthritis symptoms in patients for whom their existing Disease Modifying~     Anti-Rheumatic Drug (DMARD) treatment does not give adequate relief.~   "
242555|NCT00379587|"~     The purpose of this trial is to determine if administration of rituximab after allogeneic~     stem cell transplantation can reduce the incidence of chronic GVHD. Chronic GVHD is a medical~     condition that can occur after bone marrow or stem cells are transplanted form one individual~     to another. After the transplant, the donor immune system may recognize the recipient body as~     foreign and may attempt to reject the body. Rituximab is a drug that interferes with the~     immune system function by specifically targeting B cells and killing them.~   "
242556|NCT00379574|"~     Diffuse large B-cell lymphoma is a most prevalent non-Hodgkin's lymphoma. Recently the~     clinical results have been improved with new drugs and new modalities such as~     cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks. Bortezomib~     is well known to be effective for multiple myeloma and has been being tried for other~     malignancies including lymphoma. The investigators will incorporate Bortezomib to CHOP every~     2 weeks to further improve the clinical efficacy in diffuse large B-cell lymphoma.~   "
242557|NCT00379561|"~     This Phase 1 trial will evaluate the safety and tolerability of PSA-Activated PSA-PAH1 in~     subjects who have shown biochemical failure and have either completed at least one primary~     radiation therapy for prostate cancer and have evidence of recurrent local prostate cancer~     without metastases.~   "
242571|NCT00379379|"~     The aim of this study is to find out whether the hypoglycemic and improving insulin~     resistance effect will appear or not, when EA applying on specific acupoints of NIDDM~     patients.~   "
242558|NCT00379548|"~     We hypothesize that Asian Americans compared to Caucasians, will be at higher risk of~     developing a pro-inflammatory state that may contribute to the development of heart disease~     and diabetes when they change from a traditional Asian diet to a typical Western diet. These~     inflammatory responses will be reflected by the activation of monocytes as measured by~     protein kinase C (PKC), a known activator of monocytes.~      We also hypothesize that the changes of these inflammatory responses in the gingival~     crevicular fluid (GCF) will reflect similar changes of these markers in the plasma and~     monocytes.~      Specific aims:~        1. To compare the inflammatory responses (primarily PKC activation in monocytes), between~          Far-East Asian Americans and Caucasian Americans, when they change from a traditional~          Asian diet to a typical American diet.~        2. To correlate the biochemical changes of inflammatory responses in the plasma and~          monocytes with those in the gingival crevicular fluid (GCF).~   "
242559|NCT00379535|"~     The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on~     neuro-cognitive development of children followed up until two years.~   "
242560|NCT00379522|"~     The purpose of the present trial is therefore to assess effects of arginine vasopressin vs.~     saline placebo on hospital admission rate (primary end point), as well as hemodynamic~     variables, fluid resuscitation requirements and hospital discharge rate (secondary study end~     points) in presumed traumatic hemorrhagic shock patients with a systolic arterial blood~     pressure <90 mm Hg after 10 min of standard shock treatment. Accordingly, the study reflects~     an add-on design to standard traumatic shock therapy.~      The hypothesis is that both arginine vasopressin and saline placebo have comparable effects~     on hemodynamic variables, fluid resuscitation requirements, and hospital admission and~     discharge rate. The alternative hypothesis is that arginine vasopressin has more beneficial~     effects on hemodynamic variables, fluid resuscitation requirements, and hospital admission~     and discharge rate than saline placebo.~   "
242561|NCT00379509|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     lapatinib together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when~     given together with radiation therapy in treating patients with locally recurrent or~     chemotherapy-refractory locally advanced or metastatic breast cancer.~   "
242562|NCT00379496|"~     The aim of this study was to evaluate the effect of acupuncture as a treatment for this~     condition. Fifty-eight women diagnosed with fibromyalgia were randomly allocated to two~     groups. One group received acupuncture (n=34) twice a week for 20 sessions in addition to~     tricyclic antidepressants and exercises. The control group (n=24) received only tricyclic~     antidepressants and exercises. A blinded assessor evaluated patients’ pain using visual~     analog scale (VAS), tender points number (TePsN) and myalgic index (MI). The same assessor~     also evaluated quality of life (QoL) using SF-36. These evaluations were done prior to~     treatments, at the end of the 20 sessions, and again at six months, one year and two years~     after the first evaluation. At the end of the 20 sessions, patients who had received~     acupuncture were significantly better than those who had not in all measures of pain (VAS,~     TePsN, MI) and in five subscales of SF-36. After six months, the acupuncture group was~     significantly better than the control group in some measures of pain (TePsN and MI) and in~     three subscales of SF-36. After one year, the acupuncture group showed significant advantage~     in only one subscale of SF-36; at two years there were no significant differences between the~     two groups on all outcome measures. The addition of acupuncture to usual treatment for~     fibromyalgia is beneficial for pain and quality of life, but only in first six months.~   "
242563|NCT00379483|"~     A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was~     conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years~     with transfusion-dependent iron overload.~      The objective of this extension study is to assess the long-term safety of deferasirox and to~     provide treatment in patients with transfusional iron overload.~   "
242564|NCT00379470|"~     The study is a randomized, controlled trial, designed to test the efficacy and safety of a~     new medical device, the NovoTTF-100A. The device is an experimental, portable, battery~     operated device for chronic treatment of patients with recurrent or progressive glioblastoma~     multiforme (GBM) using alternating electric fields (termed TTFields).~   "
242565|NCT00379457|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.~      PURPOSE: This randomized phase III trial is studying different combination chemotherapy~     regimens to compare how well they work in treating young patients with nonmetastatic~     rhabdomyosarcoma.~   "
242566|NCT00379444|"~     This study will develop a culturally appropriate tobacco cessation behavioral intervention~     for Alaska Native women who are pregnant and who use tobacco. We will examine the feasibility~     of the intervention in terms of recruitment and retention of participants, acceptability to~     patients and prenatal health care providers, and the potential effectiveness of the tobacco~     use intervention.~   "
242567|NCT00379431|"~     Rituximab 1000 mg i.v. will be given on day 1 and 15, week 26 - 28, together with a~     corticosteroid regimen consisting of methylprednisolone 100 mg i.v. 30 minutes prior to both~     infusions.~   "
242568|NCT00379418|"~     AIR STUDY~      TITLE: Anti-Ischemic effects of Abciximab(Reopro)~      PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small~     stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable~     statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor).~      INTERVENTION: Heparin vs. heparin + abciximab during PCI~      PURPOSE: Measure the effects of abciximab on special healing blood stem cells~     (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on~     microvascular blood flow.~      PATIENT ASSESSMENT:~        1. 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.~        2. Measurement of blood flow in selected suitable patients~        3. 10 minute questionnaire before discharge and on visit on day 28.~   "
242569|NCT00379405|"~     Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance~     therapy, compared to standard HAART therapies.~   "
242572|NCT00379366|"~     Although ionizing radiations have been proposed for the prevention of intimal hyperplasia in~     coronary and peripheral arteries, information is lacking on how irradiation may prevent~     neointimal smooth-muscle cell proliferation and restenosis on prosthetic haemodialysis~     vascular access. We will assess the preventive effect of one dose of radiations (14 Gy)~     administered transcutaneously one day after dilatation of stenosis on prosthetic~     haemodialysis vascular access in a randomized controlled trial with a standardized clinical~     and ultrasonographic one-year follow-up.~   "
242573|NCT00379353|"~     The goal of this clinical research study is to learn if thalidomide can improve symptoms such~     as pain, fatigue,anxiety, poor appetite, depression, and sleep problems in patients with~     advanced cancer.~   "
242574|NCT00379340|"~     This phase III trial is studying how well combination chemotherapy with or without radiation~     therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable~     Histology Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Radiation~     therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination~     chemotherapy) with or without radiation therapy may kill more tumor cells.~   "
242575|NCT00379327|"~     The purpose of this study of 100 pregnant women is to determine if acupuncture using real~     needles that puncture the skin, starting at thirty seven weeks three days estimated~     gestational age (EGA), will increase the percentage of women delivering on or before the~     estimated date of confinement (EDC = 40 weeks EGA), compared with women treated identically~     but with placebo needles that do not puncture the skin.~   "
242576|NCT00379314|"~     The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for~     treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy~     and safety but is still associated with the risk of intra- and post-operative complications.~     A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which~     utilises the obturator foramen for passage of the tape, is thought to lower the risk of~     complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized~     fashion in order to detect differences in the rate of complications and in cure rate.~   "
242577|NCT00379301|"~     This study involves treatment for atrial fibrillation (AF)—the most common heart condition in~     the US—where the upper chambers of the heart beat very fast and in a disorganized manner.~     This can be felt as palpitations, tiredness, shortness of breath and passing out, plus can~     lead to stroke, damage to the heart muscle and a shorter life span. Study participants will~     receive a common treatment for atrial fibrillation called radiofrequency ablation (RFA),~     where small lesions or burns are made inside the heart to cut off the abnormal impulses~     that cause AF. The purpose of this study is to compare the effectiveness of three different~     common ablation strategies in patients with persistent or permanent AF. Subjects will be~     randomized (like drawing straws) to be treated with one of the three strategies to see if~     there is a difference in how well atrial fibrillation is controlled after treatment.~   "
242578|NCT00379288|"~     The purpose of this study is to evaluate the long-term safety of mometasone~     furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F~     MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID~     and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on~     inhaled glucocorticosteroids (ICS); evaluator-blind.~      In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of~     MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI~     500/50 mcg BID will be evaluated.~   "
242579|NCT00379275|"~     This study will evaluate patients with sarcoidosis to understand how the disease affects the~     body. Sarcoidosis is a disease that results from inflammation of body tissues. The lungs,~     lymph nodes in the chest, skin and eyes are most commonly affected. As the disease~     progresses, small lumps, or granulomas, appear in the affected tissues. In most cases, the~     granulomas clear up, but in cases where they do not heal and disappear, the tissues tend to~     remain inflamed. Eye inflammation (uveitis) associated with sarcoidosis can cause various eye~     diseases, sometimes leading to blindness. This study will examine the clinical, immunological~     and genetic features of ocular sarcoidosis.~      Patients 6 years of age and older with sarcoidosis may be eligible for this study. Candidates~     are screened with the following procedures:~        -  Completion of a questionnaire with medical, social and demographic information~        -  Blood draw for laboratory tests~        -  Complete eye examination, including measurement of eye pressure and dilation of the~          pupils to examine the back of the eye. Fluorescein angiography may be done. This test~          involves injecting a dye into a vein in the arm. The dye travels to the blood vessels in~          the eyes. A camera flashes a blue light into the eye and takes pictures of the retina~          that show whether the dye has leaked from the blood vessels into the retina. Other~          photographs of the eye may also be taken using a special camera.~      Participants are followed in conjunction with their local eye doctor as required by the~     status of their disease. Patients whose disease is stable are seen for an initial examination~     and followed every 12 months for 3 years.~   "
242580|NCT00379262|"~     The objectives of this clinical study are threefold:~        1. To compare the benefits in cancer control and survival obtained from adding~          induction-concurrent chemotherapy to radiation with those from adding~          concurrent-adjuvant chemotherapy to radiation.~        2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the~          chemotherapy plan will maintain or improve further the chemotherapy benefits while~          reducing the duration of hospital stay.~        3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as~          compared with conventional fractionation radiotherapy.~   "
242581|NCT00379249|"~     The primary objective of the study is to compare the effect of rosuvastatin therapy plus~     compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term~     cumulative direct and indirect disease-related costs during the 36 month.~   "
242582|NCT00379236|"~     This multicenter, randomized, double-blind study will be performed in approximately 600~     subjects with chronic idiopathic osteoarthritis (OA) of the knee. An open-label safety~     extension will follow.~   "
242655|NCT00378261|"~     The purpose of this study is to evaluate the utility of an electronic data capture system~     (EDCS) in a rheumatology clinical practice setting and to assess the impact of this system on~     patient satisfaction with patient-physician interaction.~   "
242583|NCT00379223|"~     Natural evolution of severe central retinal vein occlusion with low visual acuity is very~     poor. A randomized clinical trial will compare troxerutin and platelet anti-aggregating~     agents (drug treatment) versus surgery and drug treatment. Surgery will include vitrectomy~     and radial optic neurotomy. The primary outcome will be vision measured 6 months after~     surgery.~   "
242584|NCT00379210|"~     The purpose of this study is to examine behavioral and neural changes resulting from~     Mindfulness Meditation Training (MMT), and to use this knowledge in advancing our~     understanding of the mechanisms of attention.~   "
242585|NCT00379197|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Naltrexone may fight breast~     cancer by blocking the use of estrogen by the tumor cells. Naltrexone may also stop the~     growth of breast cancer by impairing blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well naltrexone works in treating women with~     metastatic breast cancer that is no longer responsive to previous hormone therapy.~   "
242586|NCT00379184|"~     Musculoskeletal pains represent a major part of pain complaints in patients. Moreover, the~     treatment of musculoskeletal pain conditions by currently available drugs is not optimal~     (Curatolo and Bogduk 2001). Thus, deep pain is a diagnostic and therapeutic problem, and~     further insights into the peripheral and central neurophysiologic mechanisms are necessary to~     improve diagnosis and therapy and to implement a mechanism-based approach. Peripheral~     sensitization and central hyper excitability are, most likely the important factors for~     chronic musculoskeletal pain and in particular osteoarthritis (OA).~      The focus of this project is to study the involvement of peripheral and central sensitization~     underlying deep tissue hyperalgesia and referred pain in male and female OA patients.~      Adequate quantitative sensory testing assessment techniques for measuring hyper excitability~     are needed to investigate, in more detail the mechanisms involved in generating the~     sensitization in OA patients.~   "
242587|NCT00379171|"~     The objective of this intervention study is to examine the effect of whole cow's milk versus~     infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth,~     nutritional status, development, risk factors for later diseases and the impact on the~     intestinal microbiota and inflammation in 9 - 12 months old infants.~   "
242588|NCT00379158|"~     1. At 12 mo of age, all three intervention groups will have significantly better iron and~          vitamin A status than the NI group.~        2. Infants who receive the Foodlet or Nutributter will have significantly greater weight~          and length gains from 6 to 12 mo and higher indices of vitamin B6, riboflavin and zinc~          status at 12 mo of age than the infants who receive the sprinkles containing iron and~          vitamin A only.~        3. Infants who receive Nutributter will have significantly greater weight and length gains~          from 6 to 12 mo and higher indices of vitamin A and essential fatty acid (linoleic,~          alpha-linolenic and docosahexaenoic, DHA) status at 12 mo of age than the infants who~          receive the Foodlet or sprinkles.~   "
242589|NCT00379145|"~     RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with~     advanced, persistent, or recurrent leiomyosarcoma of the uterus.~   "
242590|NCT00379132|"~     This study is designed to evaluate the ability of intravenously (IV)administered~     131-I-labeled TM-601 (chlorotoxin) to provide tumor-specific localization(via radiographic~     imaging) in patients with recurrent or refractory primary solid tumors with evidence of~     metastatic involvement. (Refractory tumors are non-responsive to standard treatment.) The~     safety and tolerability of IV administered 131-I-TM-601 in this patient population will be~     evaluated as part of this study.~   "
242591|NCT00379119|"~     RATIONALE: Studying changes in thymus function in patients who have been undergoing androgen~     blockade therapy for prostate cancer may help doctors learn more about how well patients will~     respond to treatment, may help in planning cancer treatment, and may help the study of cancer~     in the future.~      PURPOSE: This clinical trial is studying the effect of androgen blockade therapy on thymus~     function in older patients who have undergone radical prostatectomy for localized prostate~     cancer.~   "
242592|NCT00379106|"~     To measure arm function and quality of life of mastectomy patients.~   "
242593|NCT00379093|"~     Older persons who drink can be vulnerable to negative consequences of drinking. This trial~     aims to prevent harm from alcohol use in older adults through a program of screening and~     brief advice followed up with several health education phone calls.~   "
242594|NCT00379080|"~     This phase I/II trial is studying the side effects and best dose of tandutinib and to see how~     well it works in treating patients with recurrent or progressive glioblastoma.Tandutinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the tumor.~   "
242595|NCT00379067|"~     Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS~     0.4 mg & placebo). The study comprises a 2-week placebo run-in followed by a 12-week~     treatment period.~   "
242596|NCT00379054|"~     This study will examine the feasibility and potential effectiveness of an intervention for~     adults who want to help support a smoker to quit. The support persons will receive either~     self-help materials only or the self-help materials plus a telephone counseling intervention.~     Both interventions provide information on how support persons can encourage a smoker to quit.~   "
242597|NCT00379041|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving radiation therapy together with combination~     chemotherapy may kill more cancer cells. It is not yet known whether radiation therapy is~     more effective with or without combination chemotherapy in treating patients with Hodgkin's~     lymphoma.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works with or without combination chemotherapy in treating patients with previously untreated~     stage I or stage II Hodgkin's lymphoma.~   "
242598|NCT00379028|"~     The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy~     volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood~     concentrations of the steroids will be used as surrogate marker.~   "
242599|NCT00379015|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving epirubicin and cyclophosphamide~     followed by docetaxel and trastuzumab works in treating women with HER2-positive stage IIIB,~     stage IIIC, or stage IV primary breast cancer.~   "
242600|NCT00379002|"~     Comprehensive database from the Women's Urology Center/WISH (Women's Initiative for Pelvic~     Pain and Sexual Health) program at Beaumont.~   "
242601|NCT00378989|"~     Study hypotheses were 1) Classification of the risk of sickness absence can be made with~     questionnaires addressing self-rated health problems; 2) Occupational health intervention of~     the employees at `High Risk´ of sickness absence is more effective than usual care in~     controlling sickness absence; 3) Health advice intervention of the employees at `Increased~     Risk´ of sickness absence is more effective than usual care in controlling sickness absence;~     4) The interventions are cost-effective use of resources from the societal perspective.~   "
242602|NCT00378976|"~     Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical~     and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The~     evidence suggests that that HSV is an important cofactor in HIV transmission.~      The trial's purpose is to assess the reduction in HIV shedding associated with valacyclovir~     for suppression of HSV-2 reactivation.~      This proof-of-concept, randomized, double-blind, placebo controlled crossover trial of 20~     HIV/HSV-2 co-infected men, assessed the effects of daily valacyclovir on HIV-1 levels in the~     plasma and rectal mucosa secretions.~   "
242603|NCT00378963|"~     The purpose of this study is to determine the affects of instrumental and manual manipulation~     on the EMG response of asymptomatic subjects.~   "
242604|NCT00378950|"~     Heart failure (HF) affects 5 million people in the United States. Health literacy, which is~     the ability to read and comprehend important medical information, plays an important role in~     the health of individuals with HF. This study will evaluate the effectiveness of an~     educational program developed for various levels of health literacy at improving medical~     outcomes and quality of life in individuals with HF.~   "
242605|NCT00378937|"~     RATIONALE: Oxycodone helps lessen pain caused by cancer and may improve quality of life. It~     is not yet known whether oxycodone works better and is more cost effective than standard~     therapy in treating patients with cancer pain.~      PURPOSE: This randomized phase IV trial is studying oxycodone to see how well it works~     compared with standard pain therapy in treating patients with cancer pain and if it is more~     cost effective than standard pain therapy.~   "
242606|NCT00378924|"~     Statement of the Problem:~      Over the last several decades, scientists have made great progress in their understanding of~     cardiovascular disease. Nevertheless, much remains to be learned about the causes, course,~     and treatment of cardiovascular disease. In order to learn more about this topic, it is~     important to establish large databases of cardiovascular patients. These databases allows~     scientists to investigate, in a rigorous and precise manner, those factors that influence~     cardiovascular disease.~      How the Problem Will Be Studied:~      In the present study, we intend to establish a large database of cardiovascular patients.~     More specifically, we will create a database of approximately 12,000 cardiac catheterization~     and heart failure patients from Emory University Hospital, the Emory Clinic, Crawford Long~     Hospital, and Grady Memorial Hospital.~      We will collect a large amount of data on these patients. Data to be collected will include~     information on:~        1. medical history of the patient~        2. medical history of the patient's family~        3. health behaviors of the patient~        4. psychological status of the patient~        5. results of procedures the patient undergoes, such as catheterization/angioplasty/bypass~        6. biochemical markers in patient blood samples, including genetic/DNA markers~        7. follow-up information on patient outcomes such as mortality or re-hospitalization~      The data noted above will be collected by:~        1. administering questionnaires/interviews to the patients~        2. accessing the medical records of the patients~        3. collecting blood samples from patients which will be analyzed by laboratories for their~          biochemical content.~      Once the data has been collected, we will run a variety of statistical analyses to which will~     help us to learn more about the factors that cause various cardiovascular diseases such as~     coronary heart disease, angina, heart failure, hypertension, and stroke. The statistical~     analyses will also help us to understand how these diseases can be treated more effectively.~      How the Research Will Advance Scientific Knowledge/Human Health:~      By collecting a large amount of data on a large number of cardiovascular patients, we will be~     able to analyze, with a great deal of precision, those factors that influence the onset,~     course, and treatment of cardiovascular disease. The results of these precise analyses can~     then be used to help optimize clinical efforts to prevent and treat cardiovascular disease.~   "
242607|NCT00378911|"~     This phase II trial is studying how well sunitinib works in treating patients with recurrent~     or persistent leiomyosarcoma of the uterus. Sunitinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
242608|NCT00378898|"~     Assessing the feasibility and patient tolerance to placement of Bravo PH capsule in proximal~     esophagus.~      There will be no difference in patient-perception of a proximally-placed Bravo esophageal pH~     monitor compared with a distal monitor.~   "
242609|NCT00378885|"~     The purpose of this study is to examine the efficacy of a theory based, online tailored~     intervention on stimulating safe-sex practices among men who have sex with men (MSM). Our~     hypothesis was that a tailored internet intervention would be more effective in stimulating~     safe-sex practices of gay men than a non-tailored internet intervention when compared to a~     waiting-list control group.~   "
242610|NCT00378872|"~     We will compare the effectiveness of Quixil and Tranexamic acid in reducing bleeding during~     hip and knee joint replacements.~   "
242611|NCT00378859|"~     The objective of the study is to examine whether a 7-day high protein intake from either milk~     or meat in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3~     and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell~     function and amino acids.~   "
242612|NCT00378846|"~     RATIONALE: Comparing results of three different thermometers used to measure body temperature~     may help doctors find the most accurate thermometer to detect fever and plan the best~     treatment.~      PURPOSE: This clinical trial is studying three different types of thermometers to measure~     temperature in young patients with fever and without fever.~   "
242613|NCT00378833|"~     This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is~     appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There~     will be 6 scheduled clinic visits and 2 treatment groups.~   "
242756|NCT00376935|"~     Palifermin is a modified version of a naturally occurring human growth factor that is~     currently approved by the FDA to treat blood cancers. The purpose of this study is to~     determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected~     adults.~   "
242614|NCT00378820|"~     It is not clear which milk compounds are responsible for the growth stimulation. Through~     short term intervention studies in prepubertal children, we will test the effects of whey,~     casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids,~     oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and~     markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase,~     urine Dpyr, Ntx) as well as blood pressure.~   "
242615|NCT00378781|"~     RATIONALE: Heparin or M-EDTA may prevent catheter-related infections and blockages in~     patients at high risk for a catheter-related infection. It is not yet known whether heparin~     is more effective than M-EDTA in preventing catheter-related infections and blockages in~     patients at high risk for a catheter-related infection.~      PURPOSE: This randomized clinical trial is studying heparin to see how well it works compared~     with M-EDTA in preventing catheter-related infections and blockages in patients at high risk~     for a catheter-related infection.~   "
242616|NCT00378768|"~     RATIONALE: Biological therapies, such as antithymocyte globulin, may stimulate the immune~     system in different ways and stop cancer cells from growing.~      PURPOSE: This phase II trial is studying how well antithymocyte globulin works in treating~     patients undergoing stem cell transplant for multiple myeloma.~   "
242617|NCT00378755|"~     1. Primary Objective To assess the response rate of sequential VAD (Vincristine,~          Adriamycin, Dexamethasone) and VTD (Velcade, Thalidomide, Dexamethasone) induction~          therapy as a first line treatment for the patients with multiple myeloma~        2. Secondary Objectives~             1. To assess the progression free survival, duration of response, and overall survival~               of patients given sequential VAD and VTD induction followed by high dose therapy~               with autologous stem cell transplantation and maintenance treatment with Velcade~             2. To assess the toxicities of sequential VAD and VTD induction chemotherapy, high~               dose therapy with autologous stem cell transplantation, and of maintenance~               treatment with Velcade.~   "
242618|NCT00378742|"~     This study will collect blood and DNA samples from patients with inherited eye diseases to be~     used in research to identify genetic factors responsible for these conditions. In recent~     years, nearly 500 genes that contribute to inherited eye diseases have been identified.~     Disease-causing mutations are associated with many eye diseases, including glaucoma,~     cataracts, strabismus, corneal dystrophies and a number of forms of retinal degenerations. As~     a result, gene-based therapies are being pursued to treat eye genetic diseases that were once~     considered untreatable.~      The National Ophthalmic Genotyping Network (eyeGENE ) is creating a national tissue~     repository to further advance genetic research on inherited eye disease, while at the same~     time providing clinically-useful information back to patients and physicians who request it..~     Physicians in collaborating institutions will recruit patients to participate in the study.~     Patients will provide a blood sample and undergo a standard eye examination. The blood sample~     and clinical information will then be sent to the NEI for testing, processing and storing in~     the tissue repository. Patients are given the option to receive results back and/or to be~     re-contacted in the event of future clinical studies. Information supplied to the testing~     laboratories includes a unique identification number, the patient gender, and the patient~     date of birth. The stored samples will be made available to researchers along with~     information about the patient's disease, but without patient identifiers.~   "
242619|NCT00378729|"~     PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of~     infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of~     failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with~     Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical~     treatment could be associated to surgical complications, and medical treatment could be~     associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.~      The aim of this study is to compare the two treatments to demonstrate the equivalence of~     efficacy and the diminution of multiple pregnancies by the surgical treatments. After an~     ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical~     treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian~     hyperstimulation and IUI if the sperm is normal~   "
242620|NCT00378716|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug is a way to kill more tumor cells.~      PURPOSE: Randomized phase III trial to determine the effectiveness of uracil, tegafur,and~     leucovorin compared with fluorouracil plus leucovorin in patients with resected stage II or~     stage III colon cancer.~   "
242621|NCT00378703|"~     This randomized phase II trial studies different combinations of bevacizumab, temsirolimus,~     and sorafenib tosylate to see how well they work compared with bevacizumab alone in treating~     patients with kidney cancer that has spread to other places in the body. Monoclonal~     antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and~     spread. Bevacizumab and sorafenib tosylate may stop the growth of tumor cells by blocking~     blood flow to the tumor. Temsirolimus and sorafenib tosylate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving different combinations~     of bevacizumab, sorafenib tosylate, and temsirolimus may be more effective than bevacizumab~     alone in treating metastatic kidney cancer.~   "
242622|NCT00378690|"~     Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase~     for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with~     hormone responsive prostate cancer will be randomized and will receive either intermittent or~     continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will~     enter a long-term follow-up period for 48 months.~   "
242623|NCT00378677|"~     The purpose of this study is to investigate whether dry powder inhalation of Cyclosporine A~     is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For~     patients suffering from this syndrome often no therapeutic options are available.~     Furthermore, the side effects of the maintenance therapy leaves no room for dose increments.~     The hypothesis for this trial is that when Cyclosporine A is administered locally (in the~     lungs) chronic rejection can be treated more effectively without extra systemic side effects.~   "
242624|NCT00378664|"~     To assess the level of improvement in voiding function after lumbar to sacral ventral nerve~     re-routing procedure in Spinal Cord Injury and spina bifida patients~   "
242625|NCT00378651|"~     This study is intended to validate the use of neck auscultation with an electronic~     stethoscope during intubation to confirm tracheal tube placement.~      It is hypothesized that the ability to confirm correct tube placement with this technique~     will be similar to that of the end-tidal CO2 monitor, the current gold-standard device for~     confirming tracheal intubation.~   "
242626|NCT00378638|"~     This research focuses on women with breast cancer whose disease has not significantly~     progressed, but who have 5 or more lymph nodes involved. In this study subjects will receive~     bevacizumab, a drug which is FDA approved for colon cancer but not for breast cancer, in~     combination with a regimen of approved chemotherapy drugs known as dose dense chemotherapy.~     The study will observe the effectiveness and tolerability of this regimen.~   "
242627|NCT00378625|"~     The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine~     in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in~     Colombia. The benefit will be assessed in terms of:~        -  Efficacy~        -  Tolerability~        -  Time of fever clearance~        -  Time of parasite clearance~        -  Proportion of gametocyte carriers~   "
242628|NCT00378612|"~     ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher®~     sirolimus eluting coronary stent in native total coronary occlusion revascularization. The~     primary endpoint is binary angiographic restenosis at 6 months. The TOSCA-1 trial will be~     used as the historical control. The hypothesis is that compared with TOSCA-1 patients who~     were treated with the heparin-coated Palmaz Schatz stent, treatment with the Cypher®~     sirolimus eluting coronary stent will result in a >50% relative reduction in 6 month~     restenosis within the treated segment of the target vessel.~   "
242629|NCT00378599|"~     This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of~     pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine~     the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after~     orthotopic liver transplantation (OLT) with chronic hepatitis C (HCV) recurrence.~   "
242630|NCT00378586|"~     Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of~     oxygen. This leads to increased formation of different inflammatory and infectious markers.~      The investigators hypothesize, therefore, that there is a significant difference in the~     concentrations of inflammatory and infectious markers in the rectal mucosa between patients~     with septic shock and healthy controls.~   "
242631|NCT00378573|"~     This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS)~     after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in~     subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). PFS will be measured~     from the date of registration (ie, assignment of subject number when subject meets all entry~     criteria) to the earliest date of documented evidence of progressive disease, or the date of~     death due to any cause, whichever occurs first.~   "
242632|NCT00378560|"~     A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult~     women~   "
242633|NCT00378547|"~     Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most~     widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative~     period, and another often used analgetic, morphine, causes nausea and vomiting. The~     researchers therefore will investigate new combinations of postoperative analgesics in hopes~     of improving pain and the need for opioids during the postoperative period.~   "
242634|NCT00378534|"~     Bone marrow stem cell transplants (otherwise called bone marrow transplants) from healthy~     donors are sometimes the only means of curing hematological malignant diseases such as acute~     and chronic leukemias, myelodysplastic syndrome, myeloproliferative diseases and lymphomas.~     Before transplant the patient receives chemotherapy and radiation treatment to reduce the~     malignancy to low levels and to prevent rejection of the transplant. The transplant restores~     the blood counts to normal and replaces the patients immunity with that of the donor. The~     donor's immune cells increase the effect of the transplant by attacking remaining malignant~     cells. Donor immune cells (especially those called T lymphocytes) also attack healthy~     non-cancerous cells and tissues of the recipient causing graft-versus-host-disease (GVHD).~     Strong GVHD reactions occurring within weeks after the transplant can be life-threatening .~     In this study we remove most of the T lymphocytes from the transplant to minimize the risk of~     GVHD. However to improve immunity against residual malignant cells and boost immunity to~     infections, donor T cells (stored frozen at time of transplant) are given back around 90 days~     after the transplant when they have a reduced risk of causing serious GVHD.~      Any patient between 10 and 75 years of age with acute or chronic leukemia, myelodysplastic~     syndrome, myeloproliferative syndromes or lymphoma, who have a family member who is a~     suitable stem cell donor may be eligible for this study. Candidates are screened with a~     medical history and various tests and examinations.~   "
242635|NCT00378521|"~     The Purpose of this study is to determine the response to two different strengths of a~     topical gel containing nitroglycerin in patients with Raynaud's disease.~   "
242636|NCT00378508|"~     This is a randomized placebo controlled study to test whether a single 14 course of treatment~     with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss~     of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration~     since diagnosis.~   "
242637|NCT00378495|"~     Miltefosine will be administered to Brazilian patients with kala azar~   "
242638|NCT00378482|"~     This study is intended to provide access to CP-675,206 for patients who have previously~     received CP-675,206 in a clinical trial.~   "
242639|NCT00378469|"~     The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in~     healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45~     minutes, and urine and blood samples will be collected regularly to measure hemojuvelin,~     hepcidin, iron and transferrin levels.~   "
242640|NCT00378456|"~     The trial aimed to examine the effects of supplementation with antioxidants and folinic acid~     on the health, growth and psychomotor development of children with Down syndrome. 156~     children with Trisomy 21, less than 7 months of age were recruited and randomised into four~     groups to receive antioxidants, folinic acid, a combination of antioxidants and folinic acid~     or a placebo. Blinded outcome assessment was carried out 18 months later.Blood and urine~     samples were also taken around 12 months of age to examine metabolic effects of~     supplementation.~   "
242641|NCT00378443|"~     IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the~     etiology of the disease is not clearly understood, no specific therapeutic strategies was~     defined for IgAN. Both ACEi/ARB and steroid was found to be effective in slowing the rate of~     disease progression, but the use of steroid was restricted because of its side effects.~     However, there is no evidence from RCT on the question of whether combined use of steroid~     with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore~     undertook a randomized, multicenter study to investigate the efficacy and safety profile of~     combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of~     patients with IgAN.~   "
242642|NCT00378430|"~     Aim - To better understand expectations and attitudes of first generation immigrants from~     India to USA.~      Background - The is large difference in healthcare system as practiced in India and in USA.~     Most people who have lived in India for certain period of their life have basic understanding~     of health-care system in India. In general it is the physician who makes choices for patients~     there , also the concept of health screening is less prevalent. After immigrating to USA~     these immigrants are exposed to new healthcare system. We donot have any data showing their~     attitudes to some specific questions and physician preference in general. We also have~     significant concentration of these ethnic group in the central valley.~      With this questionnaire study we hope to get better understanding of their beliefs and~     expectations. We have tried to keep the questions simple and straightforward.~   "
242643|NCT00378417|"~     This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to~     24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal~     conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same~     control vaccine (hepatitis B vaccine).~      The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due~     to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis~     was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would~     protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine.~     The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated.~      The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine~     at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically~     for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up,~     middle ear fluid was aspirated for bacterial culture.~   "
242644|NCT00378404|"~     The purpose of this study is to assess the maximum tolerated dose of low-dose radiation in~     combination with Docetaxel in recurrent or metastatic non-small cell lung cancer for~     second-line therapy.~   "
242645|NCT00378391|"~     EUROTRANSFER Registry is a prospective, international, web-based European Registry on~     Patients with ST-Elevation MI Transferred for Mechanical Reperfusion (PCI) with a Special~     Focus on Upstream Use of Abciximab.~      This registry is designed to collect data on approximately 1800 patients during a 12 month~     enrollment period in up to 20 interventional cardiology centres with hospital transfer~     networks from all over Europe.~      Analysis of this registry should allow to monitor transfer timelines of patients arriving to~     the cath-lab from the regional hospital with or without upstream start of abciximab and~     scheduled for mechanical reperfusion (PCI) as well as to monitor regional differences across~     Europe in regard to the impact that time of various stages of the treatment chain may have on~     clinical outcomes.~   "
242646|NCT00378378|"~     The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone~     Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the~     ages of 6 and less than 18 years old. Safety will be the primary focus of this study.~   "
242647|NCT00378365|"~     To assess the role of Arsenic trioxide and/or ATRA during consolidation course in APL. It is~     hoped that the investigational arms will further increase the event-free survival at 2 years,~     with reduced toxicity and without increasing the relapse rate by comparison with a classical~     anthracycline-AraC consolidation regimen.~   "
242648|NCT00378352|"~     The purpose of this study is to evaluate whether erythropoietin can help limit the damage to~     the heart in patients with acute heart attacks.~   "
242649|NCT00378339|"~     Gold implantation around arthritic joints is a very popular treatment - but the effect has~     never been controlled.~   "
242650|NCT00378326|"~     We treat a subset of patients with paraneoplastic neurologic disorders, including those with~     Yo-mediated paraneoplastic cerebellar degeneration (PCD), the Hu syndrome, which is most~     commonly associated with small cell lung cancer (SCLC) - paraneoplastic subacute sensory~     neuropathy, encephalomyelitis, limbic encephalopathy, autonomic neuropathy - and the Ri~     Syndrome (a.k.a. Paraneoplastic Opsoclonus-Myoclonus Ataxia), as well as those patients~     suspected to have a paraneoplastic neurologic disorder but in whom a characteristic antibody~     has not yet been identified. Our treatment protocol consists of immune suppression therapy~     using tacrolimus (FK506), a potent inhibitor of lymphocyte proliferation that is commonly~     used to prevent organ transplant rejection.~   "
242651|NCT00378313|"~     The primary purpose of this study is to determine whether locally advanced breast cancer~     responds (by shrinking, by not progressing or by being destroyed) to combined chemotherapy~     (gemcitabine, epirubicin and paclitaxel) given before surgery to patients with locally~     advanced breast cancer. This study will also evaluate the toxicity of the chemotherapy~     combination to patients and will determine survival and progression-free survival 2 years~     after treatment. Also, the study will look at whether there are molecular and genetic changes~     in the tumor tissue that match the tumor's response to the chemotherapy.~   "
242652|NCT00378300|"~     The purpose of this study is to study the clinical effects of taking probiotics in patients~     who have moderate to severe atopic dermatitis. There has been several studies showing~     improvement in the severity of atopic dermatitis after taking probiotics. The mechanism of~     this improvement is currently unknown. We propose that probiotics improve atopic dermatitis~     by stimulating, or increasing, the activity of a special type of cell called the T Regulatory~     cell--which can suppress the activity of allergic disease.~   "
242653|NCT00378287|"~     The purpose of the study is to demonstrate in patients that oral rabeprazole produces~     equivalent acid suppression to intravenous pantoprazole on Day 1 of drug administration.~   "
242654|NCT00378274|"~     The purpose of the study is to investigate pain, anxiety and depression in chronic pain~     patients with and without neuropathic pain compared with healthy volunteers~   "
242656|NCT00378248|"~     Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with~     personality disorder. It's main purpose is to test the effect of a long-term combined~     treatment program compared with eclectic individual therapy for patients with personality~     disorders.~      The main study hypothesis is that long-term combined treatment is superior to eclectic~     individual therapy with respect to improvement in personality functioning, psychosocial~     functioning, symptoms, interpersonal problems, and self destructive behavior for poorly~     functioning patients with personality disorders.~   "
242657|NCT00378235|"~     IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a~     bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a~     variety of IL13-receptor positive tumor cell lines indicating that it may show a therapeutic~     benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the~     IL13 receptors was shown to be highly specific for human glioma cells.~   "
242658|NCT00378222|"~     The present study was designed in an attempt to prospectively evaluate in a randomized~     fashion whether further cytotoxic dose intensification, as delivered with two sequential~     autologous stem-cell transplantations, improved the outcome of younger patients with newly~     diagnosed multiple myeloma in comparison with a single autologous transplantation.~   "
242659|NCT00378209|"~     The purpose of this study is to evaluate the effectiveness and side effects of the~     bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory~     multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration,~     but have not been approved in the combination for treating patients in this setting.~   "
242660|NCT00378196|"~     This research is being done to look at the effects of an experimental drug, ranibizumab, for~     the treatment of a condition called idiopathic parafoveal telangiectasia or IPT. IPT is~     caused by swelling in the retina (the light sensitive tissue in the back of the eye) due to~     leaky blood vessels in this area. Swelling in the retina can lead to blurry vision.~   "
242661|NCT00378183|"~     The purpose of this study is to compare three strategies for switching patients with~     schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after~     they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. In the~     second phase of this study, investigators will assess the effectiveness of behavioral therapy~     in reducing body weight in risperdone-treated patients who are overweight or have problems~     with diabetes or blood sugar.~   "
242662|NCT00378170|"~     The primary objective is to evaluate a knewly developed blade (for intubating patients about~     to undergo surgery) and compare it to the traditional Macintosh blade~   "
242663|NCT00378157|"~     The purpose of this study is to investigate the effectiveness of an intervention aimed to~     increase joint attention in 2-4 year old children with autism. The study will be conducted in~     mainstream preschools in Norway. The intervention will be implemented by preschool teachers~     and paraprofessionals supervised by trained counselors.~   "
242664|NCT00378144|"~     The purpose of this study is to investigate the efficacy and safety for a marketed sinus~     allergy product, Sinutab, in the treatment of nasal congestion and headache.~   "
242665|NCT00378131|"~     Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by~     virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role~     in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will~     evaluate the safety and efficacy of RC-1291 HCl in cancer patients with cachexia.~   "
242666|NCT00378118|"~     Blood is the most commonly used specimen to test for HIV. In the past 20 years, use of saliva~     as an alternative specimen for HIV testing has been explored. Today, very sensitive tests~     have been formulated and have been used for diagnosing HIV in adults and older children.~     OraQuick, a rapid test, is one such example. It is a devise that can be used to collect as~     well test the saliva.~      Most studies done on the use of saliva have been carried out in adults and have produced very~     good results. However very few such studies have been done in children, especially infants.~     In adults, use of saliva has also highlighted the advantages of ease of collection and~     increased acceptability of testing.~      HYPOTHESIS OraQuick rapid test can detect antiHIV antibodies as well as the Abbott determine~     test and oral fluid testing is more acceptable than blood testing.~   "
242667|NCT00378105|"~     The purpose of this study is to determine the safety and efficacy of the bortezomib,~     lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma.~     We are looking for the highest dose of the combination that can be given safely and see how~     well it works as a combination in newly diagnosed patients.~   "
242668|NCT00378092|"~     The purpose of this study is to evaluate the outcome of medication discontinuation, the~     safety and effectiveness of re-initiating risperidone long acting injection (RLAI) in case of~     relapse (the return of a medical problem) of schizophrenia (psychiatric disorder with~     symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self) during the study observation period of 36~     months.~   "
242669|NCT00378079|"~     This five-year study examines the benefits of methadone maintenance treatment initiated in~     prison and continued in the community to male offenders who were previously, but not~     currently, heroin-dependent. It is anticipated that such prisoners will have more favorable~     outcomes in the year following release with regard to drug abuse, crime, and HIV risk~     behavior than either prisoners who receive counseling only or begin initiation of methadone~     maintenance in the community~   "
242670|NCT00378066|"~     The purpose of this study is to determine the efficacy and safety of~     bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal~     cancer.~   "
242671|NCT00378053|"~     The purpose of this study is to measure the amount of radiation over a specific period of~     time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine.~   "
242672|NCT00378040|"~     It is hypothesized that patients with vascular disease are undertreated for modifiable risk~     factors, leading to increased morbidity and mortality in this population.~      The objective of this study is to develop a comprehensive database that will demonstrate the~     current adequacy of risk factor management in this high risk population, and that will~     provide needed guidance for future treatment options.~   "
242673|NCT00378027|"~     To assess the safety and efficacy of outpatient treatment using fondaparinux and oral Vit K~     antagonist, warfarin (Coumadin) in patients with stable acute pulmonary embolus (APE)when~     initial therapy is administered in the hospital. Prospectively validate risk stratification~     criteria for predicting patient suitability for outpatient treatment of acute pulmonary~     embolism.~   "
242674|NCT00378014|"~     The study is designed to show that everolimus initiation together with reduction and~     thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal~     function in de novo liver transplant recipients as compared to continuation of CNI-based~     treatment.~   "
242675|NCT00378001|"~     The purpose of the study is to evaluate the clinical efficacy and general tolerability of two~     different subcutaneous FSH preparations (Fostimon®, IBSA vs Gonal-F®, Serono Inc.) when~     administered to patients undergoing controlled ovarian stimulation for IVF.~   "
242676|NCT00377988|"~     The purpose of the study is to use data from a health care information database to assess the~     risk of venous thromboembolism (blood clots), myocardial infarction (heart attacks), and~     stroke among women using a transdermal contraceptive system (ORTHO EVRA) for birth control~     compared with women using norgestimate-containing oral contraceptives with 35 mcg ethinyl~     estradiol.~   "
242677|NCT00377975|"~     This study compares four treatments to see which one causes the most weight loss, fat loss,~     loss of abdominal fat and improvement in blood tests like cholesterol. The four treatments~     are: Placebo, Ephedrine plus caffeine, Pioglitazone, Combined pioglitazone and ephedrine plus~     caffeine~   "
242678|NCT00377962|"~     This study investigated whether initiation of everolimus together with reduction of~     calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal~     impairment would improve renal function.~   "
242679|NCT00377949|"~     The purpose of this study is to determine the timeline of progression from pre-pulmonary~     hypertension to diagnosable pulmonary hypertension based on right heart catheterization.~     Moreover, to determine the timeline for progression from diagnosable pulmonary hypertension~     to clinical worsening of disease as defined as death, hospitalization, or worsening of PHT~     symptoms.~   "
242680|NCT00377936|"~     The intention of this trial is to evaluate safety and efficacy of a combination treatment of~     EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.~   "
242681|NCT00377923|"~     This is a multiple dose, observer blind, randomised, parallel groups pharmacodynamic and~     pharmacokinetic study to assess the endometrial effects (predecidual changes) of a new~     aqueous progesterone formulation administered s.c. at the dose of 25 and 50 mg/day.~   "
242682|NCT00377910|"~     Chronic achilles tendinopathy is a common disease especially in adults. The golden standard~     in treatment has up to now been excentric exercises but with varying success. A new~     hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study~     sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study~     the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger~     scale.~   "
242683|NCT00377897|"~     This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not~     eligible for revascularization or angioplasty. It will use exactly the same protocol as~     published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells~     (BMMNC).~   "
242684|NCT00377884|"~     Investigation of serologic bone markers in patients undergoing hip arthroplasty~   "
242685|NCT00377871|"~     Hypothesis: Stentless bioprostheses will perform superior to stented bioprostheses in~     different hemodynamic and biomechanical parameters.~      The study will investigate turbulence, flow and aortic root movement in a stentless~     bioprosthesis and compare it to a stented bioprosthesis.~   "
242686|NCT00377858|"~     A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral~     antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral~     antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.~   "
242687|NCT00377845|"~     The purpose of this study is to compare suitability, specificity and sensitivity of the~     routine smear and the tampon self-test women perform at home.~      Study hypothesis: The tampon self-test correspond to the routine cervical smear.~   "
242688|NCT00377832|"~     The most common cause of fetal tachycardia is maternal fever. Fetal tachycardia often~     precedes the maternal fever, and fetal tachycardia confounds the interpretation of electronic~     fetal monitoring (EFM), increasing the rate of cesarean delivery for non-reassuring fetal~     status (NRFS). Our hypothesis is that treatment of fetal tachycardia with acetaminophen will~     significantly lower maternal body temperature and significantly lower baseline fetal heart~     rate (FHR). The importance is that interpretation of EFM will improve, thus allowing for a~     decrease in cesarean delivery for NRFS.~   "
242689|NCT00377819|"~     The study will evaluate the efficacy and safety of transitioning postmenopausal women on~     current alendronate therapy to denosumab. Endpoints studied will include bone mineral~     density, bone turnover markers and bone histology in a subset of subjects.~   "
242690|NCT00377806|"~     This study will assess the efficacy, safety and tolerability of topically administered~     diclofenac gel versus placebo with respect to the symptom score (pain, temperature and size~     of erythema along the superficial vein)~   "
242691|NCT00377793|"~     This trial is to provide additional important information on the impact of the treatment of~     the man its ED with vardenafil on partnership. This study is being run at up to 50 study~     centers in Europe and South Africa to evaluate the use of vardenafil in adult men with~     erectile dysfunction (often called impotence), and their female partner's sexual quality of~     life. Many men experience occasional erectile problems during their lives. However, when this~     becomes a continued problem, it can affect both the man and his female partner. The causes of~     erectile dysfunction are varied and may be due to physiological or emotional reasons. This~     study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether~     treating a man its erectile dysfunction with vardenafil will improve his female partner its~     sexual quality of life. The second part (week 12) of the study (Educational program) a~     subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an~     educational program concerning ED in the from of a DVD.~   "
242692|NCT00377780|"~     This is an open phase II study evaluating the efficacy and safety of the non pegylated~     liposomal doxorubicin (Myocet®), trastuzumab (Herceptin®), and docetaxel (Taxotere®)~     combination as first-line treatment of patients with metastatic HER2/neu positive breast~     cancer.~   "
242693|NCT00377767|"~     To determine the extent to which a clinical intervention based on the Chronic Care Model~     (CCM), compared with the usual care control condition, results in a smaller age-associated~     increase in body mass index (BMI) over a 1 year intervention (primary outcome) and a 1~     1/2-year follow-up period.~   "
242694|NCT00377754|"~     Dengue is a common disease and a major health concern in the Philippines. Dengue is caused by~     a virus transmitted from the bite of an infected mosquito. The purpose of this study is to~     understand why some infants remain well or have a mild illness, and why other infants become~     very sick from this virus. Studies have shown that the mother's immune response to dengue can~     play a role in the infant's immune response and affect whether or not the infant becomes~     sick. This study will enroll up to 10,000 healthy infants 6-14 weeks old and their mothers in~     San Pablo City. At the first study visit, information about the mother and birth will be~     collected and blood samples will be taken from the mother and infant. The infant will have~     blood drawn at all 3 study visits. The infants will be followed until the age of 16 months.~     The information obtained from this study may help in the development and future testing of a~     safe and effective dengue vaccine.~   "
242695|NCT00377741|"~     This study will assess the relative bioavailability of ganciclovir from the pro-drug~     valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient~     will receive 900mg valganciclovir daily for the period specified at their center, starting as~     soon as possible after the transplant. Pharmacokinetic assessments will be made provided that~     steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (>=4 days~     of drug therapy). Blood samples for pharmacokinetic analysis will be taken up to 24h~     post-dose on one occasion. The anticipated time on study treatment is 3-12 months, and the~     target sample size is <100 individuals.~   "
242696|NCT00377728|"~     This study is in patients with seasonal allergic rhinitis(SAR)and will compare the effect~     versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber.~     GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in~     development by GSK for the treatment of allergic rhinitis, asthma and COPD.~      Subjects will be selected on the basis that they display a defined moderate response to the~     pre-determined dose used. Opportunity to assess the efficacy of compounds versus placebo at~     maximal and trough plasma concentrations.~      This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients~     with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.~      12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal~     examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge~     assessments will also be performed at various time points throughout the study.~   "
242697|NCT00377715|"~     This study will evaluate the safety and potential benefit of Dimebon as compared to placebo~     in patients with mild to moderate Alzheimer's Disease.~   "
242698|NCT00377702|"~     Cardiovascular disease (CVD) is one of the leading causes of death in the United States.~     Currently, there is little information about the lifetime risk of CVD among non-white ethnic~     groups. This study will analyze data from participants in several ongoing clinical studies to~     identify the lifetime risk for CVD among various ethnicities.~   "
242699|NCT00377689|"~     The purpose of this study is to evaluate a 5-week intervention program targeted at improving~     balance and functional skills for people with stroke.~   "
242700|NCT00377676|"~     Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces~     blood sugar by the proposed mechanism of reversing many of the metabolic alterations~     associated with insulin resistance and obesity by resetting central (hypothalamic) circadian~     organization of monoamine neuronal activities.~      The primary analysis of this study will test the hypothesis that the rate of all-cause severe~     adverse events for those receiving usual drug therapy for diabetes management plus Cycloset~     is not greater than that for usual drug therapy plus placebo by more than an acceptable~     margin. While the primary purpose of this study is to establish the safety profile of~     Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated~     as well.~   "
242701|NCT00377663|"~     Asthma is a respiratory condition that affects millions of children. It can be controlled,~     however, with the proper medications and treatment. AsthmaNet, an internet-based asthma~     management system, aims to improve the asthma care of children by providing their parents and~     doctors with appropriate tools and feedback related to asthma management. The purpose of this~     study is to evaluate the effectiveness of AsthmaNet at improving quality of care and~     controlling asthma symptoms in children.~   "
242702|NCT00377650|"~     Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy~     system leading to thrombus reduction.~      Study design:~      Multicenter, prospective, opened, randomized.~      Primary endpoints:~      ST resolution >70% 60 minutes after PCI~      Secondary endpoints:~      Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI~     thrombus scale ≥ 1 TIMI 3 flow after PCI MBG 3 CMR – infarct size, measurement of left~     ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF) ECHO:~     measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection~     fraction (EF) and wall motion score index (WMSI) Major cardiac events /cardiac death, reMI,~     rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up Rate of composite~     angiographic adverse events including: distal embolisation, transient no-reflow or slow flow,~     final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final~     thrombus score >1~   "
242703|NCT00377637|"~     This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to~     cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term~     efficacy of MMF compared to azathioprine in maintaining remission and renal function.~     Patients were randomized to receive either MMF (1.5 g twice daily [bid]) or cyclophosphamide~     (0.5-1.0 g/m^2 in monthly pulses) in the induction phase. Those patients meeting criteria for~     response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g~     bid) or azathioprine (2 mg/kg/day).~   "
242757|NCT00376922|"~     RATIONALE: Listening to relaxing music during a bone marrow biopsy may be effective in~     reducing anxiety and pain.~      PURPOSE: This randomized clinical trial is studying how well music works in reducing anxiety~     and pain in adult patients undergoing bone marrow biopsy for hematologic cancers or other~     diseases.~   "
242704|NCT00377624|"~     Three-arm, parallel, double-blind, masked observer, randomized, PB-Saline controlled clinical~     trial. In order to avoid problems in the interpretation of the final results due to disparate~     enrollment from various centers, the number of patients enrolled per site will be the same~     per site. Study patients will be randomized to receive either 20 mg sodium hyaluronate, 3~     i.a. sodium hyaluronate injections, followed by 2 PBSaline mock i.a. injections or 5 i.a.~     PB-Saline control injections. One investigator will administer the injection and the joint~     assessor will be blinded to the study. The anterior or posterior approach for the shoulder~     injection will be used.~   "
242705|NCT00377611|"~     An observational study to investigate the incidence of influenza and influenza-related~     complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated~     with Fluarix™~   "
242706|NCT00377598|"~     The purpose of this study is to evaluate the efficacy of TAK-583, once daily (QD), in~     relieving pain in subjects with postherpetic neuralgia.~   "
242707|NCT00377585|"~     The study is designed to demonstrate a meaningful difference in immunogenicity between the~     candidate adjuvanted vaccine compared to the licensed Fluarix vaccine in subjects aged 50~     years and above.~      A control group in younger adults aged 18 to 40 years was included.~   "
242708|NCT00377572|"~     The purpose of this study is to find out if adding omalizumab to standard asthma treatment~     results in a safer, more effective, and longer lasting asthma treatment strategy than~     standard treatment alone, in inner-city children with mild to severe asthma.~   "
242709|NCT00377559|"~     This is an open phase II multicentre study evaluating the efficacy and safety of the non~     pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line~     treatment of patients with metastatic HER2/neu negative breast cancer.~   "
242710|NCT00377546|"~     To compare the penetration of three different NSAIDs.~   "
242711|NCT00377533|"~     Currently available wheelchairs are often fitted with conventional rear anti-tip devices~     (C-RADs) to prevent wheelchair rear tips. The limitations of C-RADs have provided an~     incentive for the design of rear anti-tip devices that permit more rear tip without~     compromising safety (Arc-RADs).~      The purpose of this study is to test the hypothesis that caregivers handling occupied~     wheelchairs equipped with Arc-RADs have higher success rates on RAD-relevant skills than~     caregivers handling wheelchairs equipped with C-RADs.~   "
242712|NCT00377520|"~     The intent of this protocol is to screen a new agent for activity in patients with advanced~     or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed~     disodium works in treating patients with advanced or recurrent endometrial carcinoma.~   "
242713|NCT00377507|"~     The Purpose of this study is to evaluate the effects of catechin mouth-washing on the removal~     of intraoral bacteria in the elderly~   "
242714|NCT00377494|"~     The purpose of this study is to evaluate the safety, tolerability, and effectiveness of 2~     doses of a malaria vaccine (DNA) followed by a dose of another type of malaria vaccine (MVA)~     given as a booster. Forty-eight adults in Ghana, ages 18-50 years, will participate for 17~     months. They will be randomly assigned to 1 of 4 treatment groups. Group 1 will receive the~     DNA malaria vaccine at months 0 and 1, and the booster at month 7. Group 2 will receive a~     rabies vaccine at months 0 and 1, and an injection containing no vaccine at month 7. Group 3~     will receive the DNA malaria vaccine at months 5 and 6, and the booster at month 7. Group 4~     will receive the rabies vaccine at months 5 and 6, and an injection containing no vaccine at~     month 7. Blood samples and information regarding health problems that may occur after~     vaccination will be collected.~   "
242715|NCT00377481|"~     This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin~     alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive~     comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon~     (6000IU). They will then be crossed over to the alternative treatment arm for further~     treatment. After each injection pain will be assessed using the visual analogue scale (VAS)~     and 6-point verbal rating scale (VRS), and patient preference will be assessed. The~     anticipated time on study treatment is <3 months, and the target sample size is <100~     individuals.~   "
242716|NCT00377468|"~     The purpose of this study is to determine whether application of low dose~     Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with~     acute CRPS.~   "
242717|NCT00377455|"~     The purpose of this study is to determine whether the drug Bosentan improves exercise~     tolerance in scleroderma patients.~   "
242718|NCT00377442|"~     This study will assess the potential pharmacokinetic interaction between GK Activator (2) and~     simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK~     Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6~     treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin~     80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study~     days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The~     anticipated time on study treatment is <3 months, and the target sample size is <100~     individuals.~   "
242719|NCT00377429|"~     The purpose of this study is to determine whether the investigational drug catumaxomab~     delivered in the planned treatment schedule is a safe and effective treatment for women with~     advanced ovarian cancer who experience a complete response to chemotherapy.~   "
242720|NCT00377416|"~     Individuals with a deficiency of the Alpha 1-antitrypsin (AAT) protein are at risk for~     developing emphysema and liver damage. Researchers have developed a way to introduce normal~     AAT genes into muscle cells so that the AAT protein is produced at normal levels. This study~     will evaluate the safety of the experimental gene transfer procedure in individuals with AAT~     deficiency.~   "
242740|NCT00377156|"~     RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause~     less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells.~     It is not yet known whether stereotactic radiation therapy is more effective with or without~     whole-brain radiation therapy in treating patients with brain metastases.~      PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and~     whole-brain radiation therapy to see how well they work compared with stereotactic radiation~     therapy alone in treating patients with brain metastases.~   "
242721|NCT00377403|"~     This study will compare the symptom relief provided by 5 cold medicines versus the symptom~     relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who~     have sinus infections. Treatment with amoxicillin may be more effective than treatment with~     cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus~     infections will participate in this study for 28 days. Volunteers will receive a 10-day~     course of either amoxicillin or placebo (substance containing no medication). In addition,~     all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and~     cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10,~     and 28 following the start of treatment. The study will look at quality of life factors such~     as change in functional status (ability to perform daily activities) and symptoms, recurrence~     of the infection, satisfaction with care, and the direct costs of treatment.~   "
242722|NCT00377390|"~     The purposes of this study are to determine the effects of omalizumab on cells involved in~     the allergic response, to evaluate predictors of response to omalizumab, and to determine~     whether response to omalizumab therapy is influenced by the environment. A subset of~     inner-city children and adolescents currently enrolled in Inner-City Anti-IgE Therapy for~     Asthma (a clinical trial of omalizumab) will be enrolled in this study.~   "
242723|NCT00377377|"~     EP01572 is a peptidomimetic growth hormone secretagogue, which has potent GH-releasing~     activity after intravenous administration.It is an analogue of the natural compound ghrelin.~     Since an oral delivery system would be preferable in many of the possible therapeutic~     indications, the pharmacological profile and the GH-releasing activity of increasing single,~     oral doses of EP01572 in healthy volunteers will be evaluated. In addition, the~     pharmacokinetics and pharmacological effects of EP01572 will be investigated after~     intraduodenal administration.~   "
242724|NCT00377364|"~     Studies in humans and animals support that stress and/or elevations in corticosteroids lead~     to changes in hippocampal structure and functioning. This is important as patients with major~     depression frequently have elevated cortisol, and millions of patients receive prescription~     corticosteroids (e.g. prednisone). Both depression and corticosteroid therapy are associated~     with memory impairment and hippocampal atrophy. Our research uses corticosteroid-treated~     patients to explore interventions that might protect the brain from the effects of stress or~     corticosteroids. We propose to give 30 corticosteroid-treated asthma patients acetaminophen~     or placebo. Between group differences in mood, memory and other neurocognitive measures will~     serve as outcome measures.~   "
242725|NCT00377351|"~     Amyotrophic Lateral Sclerosis (ALS) is a rare but rapidly progressive neurological disease~     that often results in death within a few years after the diagnosis. The incidence of ALS in~     the US is approximately 2.0/100,000/year and is age dependent. Very few epidemiological~     studies have investigated the causes of ALS. Last year, Dr. Alberto Ascherio at Harvard~     School of Public Health successfully obtained a RO1 grant to investigate the risk of ALS by~     documenting ALS cases in five well-established large prospective cohorts: The Nurses' Health~     Study (NHS), the Health Professionals Follow-up Study (HPFS), the Cancer Prevention Study II~     Nutrition Cohort (CPS IIN), the Multiethnic Cohort (MEC), and the NIH-American Association of~     Retired Persons Diet and Health Study (AARP-DH). The primary aims of this grant are to~     prospectively clarify the associations between diet and smoking and risk of ALS in this to~     date the largest epidemiological study on ALS. Incident ALS cases will be documented via~     biennial questionnaires in the first three cohorts. While mortality data will be obtained in~     the MEC and AARP-DH cohorts by searching the National Death Index (NDI) Plus, it is also~     desirable to identify surviving incident cases in these two cohorts.~      The objective of this specific proposal is to ascertain the self-reported incident ALS cases~     from the AARP-DH study and obtain consent for medical release following the procedures set up~     for Parkinson's disease (PD) cases in the currently approved Parkinson's Genes and~     Environment (PAGE) Study IRB approval #06-E-N093. The confirmed ALS cases may be analyzed as~     part of the RO1 project. We expect to identify 300 self-reported ALS cases from the AARP~     cohort. Detailed analytic plans will be coordinated with Dr. Ascherio.~   "
242726|NCT00377338|"~     Fibered confocal fluorescence microscopy (FCFM), also referred to as Cell-Vizio® (MaunaKea~     Technologies, France) is a new technique that produces microscopic imaging in a living~     tissue, through a 1 mm fiberoptic miniprobe that can be introduced into the working channel~     of the bronchoscope. The system produces real-time imaging of endogenous fluorophores with a~     5 µm lateral resolution and a field of view of 600 x 600 µm. FCFM is able to produce dynamic,~     high-resolution microimaging of the respiratory bronchiolar walls, alveolar ducts and sacs in~     vivo during endoscopy (a procedure termed as alveoscopy).~      The hypothesis of this study is that an alveoscopy makes it possible to analyze the~     microstructure of the distal airways in vivo and to collect specific morphologic information~     in patients with interstitial lung diseases.~      The goals of this French Phase II trial are:~        -  to evaluate the tolerance of the alveoscopy~        -  to describe the normal appearance of the bronchoalveolar system in spontaneous~          ventilation in normal subjects~        -  to describe specific alterations of the bronchoalveolar microstructure in focal or~          diffuse interstitial lung diseases~   "
242727|NCT00377325|"~     This study will evaluate whether lower doses of cyclosporine can cause fewer side effects and~     still produce the same beneficial results that are seen with a standard cyclosporine dose~     regimen when treating individuals with moderate to severe psoriasis.~   "
242728|NCT00377312|"~     Study consists of an eight day inpatient visit on the General Clinical Research Center. The~     investigators' specific aims are to:~        1. To define the maximum safe dose of a seven day continuous administration of parathyroid~          hormone [PTH(1-34)] in healthy human volunteers.~        2. To estimate the effect of a seven day continuous administration of parathyroid Hormone~          (PTH) in escalating doses on vitamin D metabolism, markers of bone turnover and~          fractional excretion of urine.~   "
242755|NCT00376948|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Genistein may help gemcitabine and erlotinib kill more tumor cells by making tumor~     cells more sensitive to the drugs.~      PURPOSE: This phase II trial is studying how well giving genistein together with gemcitabine~     and erlotinib works in treating patients with locally advanced or metastatic pancreatic~     cancer.~   "
242729|NCT00377299|"~     Bipolar disorder (BD) is a common and severe psychiatric illness. Drug and alcohol abuse are~     very common in people with BD and other mood disorders and are associated with increased~     rates of hospitalization, violence towards self and others, medication non-adherence and~     cognitive impairment. However, few studies have investigated the treatment of dual-diagnosis~     patients as substance use is frequently an exclusion criterion in clinical trials of patients~     with BD. To address this need, we have developed a research program that explores the~     pharmacotherapy of people with BD and substance related-disorders. A potentially very~     interesting treatment for BD is citicoline. Some data suggest that this supplement may~     stabilize mood, decrease drug use and craving, and improve memory. We found promising results~     with citicoline in patients with BD and cocaine dependence. In recent years the use of~     amphetamine and methamphetamine has become an important public health concern. However,~     virtually no research has been conducted on the treatment of amphetamine abuse. We propose a~     double-blind placebo controlled prospective trial of citicoline in a group of 60 depressed~     outpatients with bipolar disorder, depressed phase or major depressive disorder and~     amphetamine abuse/dependence, to explore the safety and tolerability of citicoline, and its~     efficacy for mood symptoms, stimulant use and craving and its impact on cognition. Our goal~     is to determine which symptoms (e.g. mood, cognition, substance use) citicoline appears to be~     most effective and estimate effect sizes for future work.~   "
242730|NCT00377286|"~     The goal of this study is 1) to develop a biomarker of of cartilage synthesis by determining~     if there is a relationship between changes in the status of knee cartilage and the amount of~     a biomarker called CTX-II in urine. 2) We will also characterize people who have experienced~     cartilage loss and/or reduced functional ability using performance tests and a questionnaire.~     3) The administration of glucosamine in a beverage for six months will be used to promote the~     alteration in cartilage status and improve function in people with mild to moderate joint~     pain. A secondary goal will be to assess the effect of glucosamine on the skin in a small~     subset of women.~   "
242731|NCT00377273|"~     This study is being undertaken to: 1. assess the safety of fluorouracil cream for the~     treatment of actinic keratoses (AKs) on other common skin surface areas (e.g., posterior~     scalp, ears, neck, lips, arms and hands); 2. collect additional post-treatment safety data on~     fluorouracil cream applied to the face (including anterior scalp, if applicable); 3. assess~     the incidence of recurrence of AKs on the face; and 4. assess the need for re-treatment with~     fluorouracil cream to the face.~   "
242732|NCT00377260|"~     The purpose of this study is to learn whether or not all children with ear infections (acute~     otitis media or AOM) should be treated with antibiotics. The study will compare two treatment~     strategies, watchful waiting or treatment with antibiotics, to determine which is more~     appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23~     months, with AOM will be enrolled in the study. They will be treated either with Augmentin~     (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will~     be asked to write information about their child in a Patient Diary. A general physical exam,~     including an ear exam, will be performed 4 times during the study. A mucus sample will be~     collected from the back of each child's nose. Parents will be asked questions during phone~     calls and at every visit. If a child has not improved or has worsened, the investigators will~     prescribe a different antibiotic that is known to kill resistant germs.~   "
242733|NCT00377247|"~     The primary goal of this study is to determine if the vaccine can be safely given to~     subjects, and to see what side effects occur (both good and bad) when they are given this~     experimental tumor vaccine. During this study, investigators intend to watch for tumor~     response while examining the effects of this vaccine on the body's immune system after it is~     given.~   "
242734|NCT00377234|"~     This 2 arm crossover study will evaluate patient reported preference for either once monthly~     Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal~     osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12~     weeks; they will then cross over to receive the alternative treatment for a further 12~     weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample~     size is 100-500 individuals.~   "
242735|NCT00377221|"~     Observational, cross-sectional, single-visit study of 896 men and women in Los Angeles, CA~     and Baltimore, MD including a computer-assisted interview focusing on the behavioral~     repertoire surrounding RAI, symptoms, and health seeking behaviors and a multidimensional~     assessment of behaviors, anorectal examination, and testing for sexually transmitted~     infections (STIs).~   "
242736|NCT00377208|"~     High blood pressure affects 65 million adults in the United States, and more than one third~     of these individuals do not have adequate control of their blood pressure. Individuals who~     ask specific questions and discuss important medical issues with their doctors are more~     likely to receive appropriate medical care than individuals who do not. This study will~     evaluate the effectiveness of an interactive web site that provides individualized feedback~     and encourages doctor-patient communication as a way to maintain adequate blood pressure~     control.~   "
242737|NCT00377195|"~     This prospective study will test the following hypotheses in patients with stage I-II low~     grade marginal zone (MZ) lymphoma:~        -  Involved Field Radiotherapy will produce a complete response rate of > 90%~        -  Radiotherapy will be associated with a locoregional progression of < 20% after 10 years~        -  Death from MZ lymphoma will occur in < 40% of patients within 10 years of radiotherapy~      This study secondary objectives are:~        -  To collect information on the prevalence of H. pylori in non-gastric MALT lymphoma~        -  To estimate rates of acute and late toxicity of radiotherapy~   "
242738|NCT00377182|"~     This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor~     pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS~     + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to~     receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV~     polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All~     patients who receive at least one dose of study medication will receive open label PEGASYS +~     Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time~     on study treatment is 3-12 months, and the target sample size is <100 individuals.~   "
242739|NCT00377169|"~     The purpose of this study is to collect blood samples from SMART study participants to use in~     future genetic studies.~   "
242741|NCT00377143|"~     Warfarin (also called Coumadin®) is an anticoagulant drug (blood thinner) given to patients~     to help prevent blood clots from forming or to help prevent the growth of an existing blood~     clot. The purpose of this study is to collect information on a possible method used to~     determine the best warfarin dose for people before they start warfarin. This study will focus~     on finding out if a person's stable dose can be better predicted by using a new approach~     (called pharmacogenetic-guided dosing) compared to the current warfarin dosing method. The~     pharmacogenetic-guided dosing method (the new warfarin dosing method) will use a person's~     specific health and genetic information to calculate a patient's warfarin dose at the~     beginning of warfarin treatment. The hope is that through this research, we may someday be~     able to use an individual's genetic information to guide the selection of their specific~     warfarin dose at the beginning of treatment, leading to precise warfarin dosing and less need~     for the current trial and error process.~   "
242742|NCT00377130|"~     RATIONALE: A stress-management program may improve quality of life and reduce anxiety and~     depression in patients receiving chemotherapy for cancer.~      PURPOSE: This randomized clinical trial is studying how well stress management therapy works~     in patients receiving chemotherapy for cancer.~   "
242743|NCT00377117|"~     The purpose of this study is to learn more about the relationship between serious mental~     illness and the detection and management of diabetes and pre-diabetic conditions. Patients~     who have been diagnosed with schizophrenia are at an increased risk for developing diabetes~     and pre-diabetic conditions such as impaired glucose tolerance and impaired fasting glucose.~     In addition, novel antipsychotics have also been linked to impaired glucose metabolism and~     increased incidence of diabetes. The medical management of these patients may be difficult ot~     achieve through standard family practice. The objectives of this project are to: screen a~     sample of this high-risk population using an Oral Glucose Tolerance Test (OGTT), and to~     provide multidisciplinary team support to those identified as having diabetes or a~     pre-diabetic condition.~   "
242744|NCT00377104|"~     This phase I trial is studying the side effects and best dose of flavopiridol in treating~     patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used~     in chemotherapy, such as alvocidib, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing.~   "
242745|NCT00377091|"~     This study compares two blood thinners which are both accepted standard cares, fondaparinux~     and unfractionated heparin (UFH). These drugs are used to prevent the growth of existing~     blood clots and formation of additional blood clots in patients with pulmonary embolism (a~     blood clot in the lung) as they are beginning to take warfarin (another standard care blood~     thinner). Patients will be invited to participate because they have been diagnosed with a~     pulmonary embolism, require anticoagulation therapy (treatment with a blood thinner), and are~     currently hospitalized.~      The purpose of this study is to determine if patients treated with fondaparinux will have~     shorter hospital stays and lower costs of treatment while in the hospital than similar~     patients receiving a different standard care with UFH. Fondaparinux is already approved by~     the FDA for use in patients with pulmonary embolism, for both inpatient and outpatient care,~     as long as treatment is begun with warfarin while they are hospitalized. It is therefore not~     an experimental treatment. The study is being conducted to determine which FDA approved~     treatment is the best practice for hospital treatment of pulmonary embolism. The study will~     also examine the safety and effectiveness of fondaparinux in local use.~   "
242746|NCT00377078|"~     Primary objective of this pilot study is to evaluate the effect of recombinant human~     lactoferrin on the rate of infection with Clostridium difficile in long-term care patients~     supported by enteral feeding requiring broad spectrum antibiotics.~   "
242747|NCT00377065|"~     This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1~     infection in patients who have limited or no treatment options due to virological failure,~     resistance, or intolerance to multiple antiretroviral regimens. Enrollment in this study is~     patient driven. Investigators are not proactively assigned. There is no target sample size~     and duration of the study is indefinite. For information on how to enroll in the study, see~     link below.~   "
242748|NCT00377052|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,~     such as gemcitabine, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Bortezomib may help gemcitabine work~     better by making cancer cells more sensitive to the drug.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine~     works in treating patients with relapsed mantle cell lymphoma.~   "
242749|NCT00377039|"~     This is a multicentre, randomized, double-blind, placebo controlled, parallel group~     exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the~     treatment of fibromyalgia in female subjects.~   "
242750|NCT00377026|"~     This a pilot intervention study in which postpartum women will be randomized to receive a~     6-month postpartum weight loss intervention or usual care.~   "
242751|NCT00377000|"~     Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One~     dispensed in a pump presentation, the other in a tube presentation.~   "
242752|NCT00376987|"~     RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA~     damage.~      PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium~     levels in smokers.~   "
242753|NCT00376974|"~     With patient education, the compliance with glaucoma medications will increase.~   "
242754|NCT00376961|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and~     bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the~     cancer from progressing.~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy and bortezomib followed by bortezomib alone works in treating patients with~     newly diagnosed mantle cell lymphoma.~   "
242758|NCT00376909|"~     RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing~     cancer screening, and offering encouragement to them over the telephone, may help improve~     cancer screening rates.~      PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention~     Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal~     cancer in minority and low-income women.~   "
242759|NCT00376896|"~     This is a three-period crossover study to compare GW876008 and placebo to see if GW876008~     will normalise blood flow responses after different emotional stimuli.~   "
242760|NCT00376883|"~     Multiple myeloma is a malignant hematological disease dominated by monoclonal plasma cells in~     the bone marrow. Major symptoms are related to the bones due to an increased bone resorption~     and a decreased bone formation leading to bone pain and increased risk of fractures. The~     normal osteoclasts are responsible for bone degradation through stimulation from the~     malignant plasma cells. Bisphosphonates have been shown to inhibit the osteoclast activity~     but may have serious side-effects due to renal toxicity and the optimal dose have not been~     established.~      In a randomized double blinded design it is aim to compare the standard of monthly injections~     of 90 mg pamidronate with 30 mg.~      The primary end-point is physical function estimated by EORTC QLQ-C30 questionnaire at 12~     months after starting the treatment in newly diagnosed treatment demanding multiple myeloma.~     Secondary end-points are skeletal related events, cost-utility analysis, response, response~     duration and survival and quality of life with respect to fatigue and pain.~   "
242761|NCT00376870|"~     Restenosis requiring reintervention is still a limitation of percutaneous coronary~     angioplasty. Despite the use of Drug eluting stent (DES), the rate of restenosis remains 7%~     to 16% in diabetic patients, making it a challenging problem in interventional cardiology.~      Still, in clinical trials, most of these attempts did not successfully limit neointimal~     formation after coronary stenting.~      Thiazolidinediones (TZDs), like pioglitazone (pio) or rosiglitazone, are a novel class of~     oral antidiabetic agents currently used to treat patients with type 2 diabetes mellitus.~      These agents increase insulin sensitivity and, as such, have favorable effects on blood~     glucose levels and the lipid profile in treated patients.~      Beyond their metabolic action, TZDs have been shown to exhibit antiinflammatory and~     antiatherogenic effects in vascular cells in vitro and to limit lesion development in various~     animal models of arteriosclerosis.~      Moreover, TZDs inhibit VSMC proliferation and migration, 2 critical processes in neointimal~     formation after coronary stenting.~      Data from rodent models suggest that TZDs limit intimal proliferation after vascular injury,~     and in clinical studies with type 2 diabetic coronary artery disease (CAD) patients, TZDs~     have been shown to reduce neointimal formation as well as restenosis after coronary stent~     implantation.~      Still, it remains unclear to what extend these effects depend on the metabolic action of~     these drugs and what might mainly be due to the improvement in glycemic control.~      Recently a few reports on prevention of restenosis in type 2 diabetic patients (T2DM) with~     the use of TZDs as been published. All of them uses BMS as endoprosthetic devices. None of~     these evaluated the use of TZDs in combination with DES.~      Aim of the study is to evaluate the efficacy of pioglitazone in prevention of in-stent~     restenosis after successful implantation of a sirolimus-eluting coronary stent for treatment~     of de-novo complex coronary vessel disease in patients with T2DM and stable coronary artery~     disease.~      Study primary end-point are late-loss at 9 months.Secondary end-point include binary~     restenosis MACE at 1, 9 and 12 month, stent thrombosis at 12 months.~   "
242762|NCT00376857|"~     It was the aim of the present study to prospectively compare the functional and morphological~     outcome of idiopathic epiretinal membrane surgery with and without the assistance of~     Indocyanine green (ICG). The main outcome measure was improvement of best-corrected visual~     acuity (BCVA). This was treated as an open question and we had no hypothesis which of the two~     therapies was superior.~   "
242763|NCT00376844|"~     RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells.~     Implant radiation therapy uses radioactive material placed directly into or near a tumor to~     kill tumor cells. Giving external-beam radiation therapy or implant radiation therapy after~     surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the~     tumor may not need more treatment until it progresses. In this case, observation may be~     sufficient. It is not yet known whether radiation therapy is more effective than observation~     when given after surgery in treating stage I endometrial cancer.~      PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or~     implant radiation therapy to see how well they work compared with observation in treating~     patients who have undergone surgery for stage I endometrial cancer.~   "
242764|NCT00376831|"~     Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy~     procedure.~      There are various protocols and methods used to prevent discomfort and alleviate pain.~     Conscious sedation is one of the options recommended by the American Society for~     Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the~     physician's discretion.~      This study will attempt to recommend a preferred protocol based on a double blind randomized~     prospective method.~      The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and~     fentanyl for sedation in ambulatory colonoscopies.~      The results will be compiled from objective data and patient and physician interviews.~   "
242765|NCT00376818|"~     RATIONALE: Yoga, meditation, and breathing exercises may help lower stress and improve~     quality of life in patients with malignant brain tumors and their family caregivers.~      PURPOSE: This clinical trial is studying how well a stress reduction program works to improve~     the quality of life of patients with malignant brain tumors and their family caregivers.~   "
242766|NCT00376805|"~     RATIONALE: Giving chemotherapy before a donor natural killer (NK) cell infusion helps stop~     the growth of tumor cells. It also helps stop the patient's immune system from rejecting the~     donor's cells. Giving NK cells from a related donor may kill the tumor cells.~      PURPOSE: This study furthers the research of previous studies (MT2003-01 and MT2004-25) which~     were to determine a specific preparatory regimen (cyclophosphamide and fludarabine) could~     create an environment in which infused NK cells can grow and effectively treat patients with~     relapsed AML. This study will test the previous regimen in patients with breast cancer.~   "
242767|NCT00376792|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     docetaxel after surgery may kill any tumor cells that remain after surgery. Sometimes, after~     surgery, the tumor may not need more treatment until it progresses. In this case, observation~     may be sufficient. It is not yet known whether giving docetaxel after surgery is more~     effective than observation in treating prostate cancer.~      PURPOSE: This randomized phase III trial is studying docetaxel to see how well it works~     compared with observation in treating patients who have undergone radical prostatectomy for~     prostate cancer.~   "
242795|NCT00376428|"~     Suppression of stop mutations in the CFTR gene with parenteral gentamicin can be predicted in~     vitro and is associated with clinical benefit and significant modification of the~     CFTR-mediated chloride transport in nasal and sweat gland epithelium.~   "
242768|NCT00376779|"~     The purpose of this study is to show that the immunogenicity of newly formulated~     DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed~     formulation of the vaccine. The vaccine will be administered as a primary vaccination course~     to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be~     assessed.~   "
242769|NCT00376766|"~     This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy~     and safety, in epilepsy cluster seizure.~      Efficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient~     has a seizure during this interval, he is considered as a non-respondent patient.~   "
242770|NCT00376753|"~     This study will examine and compare brain activity in people with focal hand dystonia (FHD)~     and healthy volunteers to obtain further knowledge about the underlying cause of FHD.~     Patients with dystonia have muscle spasms that cause abnormal postures while trying to~     perform a movement; FHD affects the hands and fine finger movements. During fine finger~     movement, the brain controls muscles in a process called surround inhibition. This process~     may be impaired in people with hand dystonia, leading to uncontrolled overactivity in muscles~     and impairing motor function.~      Healthy volunteers and patients with FHD over 18 years of age may be eligible for this study.~     Candidates are screened with a physical and neurological examination.~      In a series of three experiments conducted during a single clinic visit, participants undergo~     transcranial magnetic stimulation (TMS) while performing a finger movement. A wire coil is~     placed on the subject's scalp. A brief electrical current is passed through the coil,~     creating a magnetic pulse that travels through the scalp and skull and causes small~     electrical currents in the outer part of the brain. The stimulation may cause muscle, hand or~     arm twitching, or may affect movement or reflexes. During the stimulation, the subject is~     asked to contract one finger.~      In addition to TMS, subjects have surface electromyography. For this test, they sit in a~     chair with their hands placed on a pillow on their lap. The electrical activity of three~     muscles in the right hand is recorded by electrodes (small metal disks) taped to the skin~     over the muscles.~   "
242771|NCT00376740|"~     The purpose of this study is to determine whether zoledronic acid given intravenously every 6~     months can prevent reduction in bone mineral density in women with early stage breast cancer~     receiving adjuvant therapy with the aromatase inhibitor drug letrozole, after having received~     adjuvant tamoxifen.~   "
242772|NCT00376727|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them.~      PURPOSE: This phase I trial is studying the side effects and best dose of cetuximab in~     treating patients with advanced solid tumors.~   "
242773|NCT00376714|"~     GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being~     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long~     duration of action of GSK233705 when administered via inhalation in animal models supports~     the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary~     disease.~   "
242774|NCT00376701|"~     The primary purpose of the study is to investigate whether patients with Choroidal~     Neovascularization secondary to Age-related Macular Degeneration, receiving triple or double~     therapy compared to monotherapy with Avastin will reduce the intervention rate with~     equivalent safety and efficacy.~   "
242775|NCT00376688|"~     This phase II trial studies how well temsirolimus works in treating patients with locally~     advanced or metastatic breast cancer. Temsirolimus may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
242776|NCT00376675|"~     RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known~     whether methylphenidate is more effective than a placebo in relieving fatigue and improving~     quality of life in patients with cancer.~      PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works~     in treating patients with fatigue caused by cancer.~   "
242777|NCT00376662|"~     To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT~     plus etidronate and no treatment over 5 years in the prevention and treatment of~     glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.~   "
242778|NCT00376649|"~     Subjects that participate in the practical workshop will improve their quality of life and~     will stay longer in remmision , in compare to the participants that will continue their~     regular threatment~   "
242779|NCT00376636|"~     This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood~     pressure in patients with mild to moderate hypertension.~   "
242780|NCT00376623|"~     The trial will be performed to evaluate whether BI 2536 may be effective in the treatment of~     advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed~     first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the~     further Phase II and III clinical programme of BI 2536. To achieve this objective two dosage~     schedules are compared.~   "
242781|NCT00376610|"~     ASR/Re-cap versus 28 MoM~   "
242782|NCT00376597|"~     This randomized phase III trial studies how well education with or without physical therapy~     intervention works in preventing lymphedema in women with stage I, II, or III breast cancer~     who are undergoing axillary lymph node dissection (surgery to remove lymph nodes found in the~     armpit region). Lymphedema is a condition in which extra lymph fluid builds up in tissues and~     causes swelling in an arm or leg if lymph vessels are blocked, damaged, or removed by~     surgery. A personalized physical therapy intervention and education materials may be better~     than education materials alone in preventing lymphedema in women with breast cancer who are~     undergoing axillary lymph node dissection.~   "
242783|NCT00376584|"~     This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is~     appropriate to evaluate the efficacy of MK0524 to improve the tolerability of~     extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.~   "
242784|NCT00376571|"~     How to use drug eluting stents (DES) in bifurcation lesions. A strategy of routine stenting~     of both main vessel and side branch versus a strategy of routine main vessel stenting and~     optional treatment of side branch. A randomized Nordic multicenter study including 400~     patients with angina pectoris with clinical angiographic follow-up.~   "
242785|NCT00376558|"~     The purpose of this study is to determine whether patients with the greatest loss of dopamine~     transmission due to cocaine dependence at pre-treatment PET and MRI scans will be those who~     fail to respond to substance abuse treatment. This study will also determine whether patients~     who do respond to treatment will experience a recovery of dopamine function. This study~     includes free brain imaging and behavioral intervention. Compensation provided for the brain~     scans.~   "
242786|NCT00376545|"~     This study will explore how the areas in the brain are connected to link what people see to~     what they do; that is, how they use what they see to help guide their movements. The study~     uses functional magnetic resonance imaging (fMRI) to look at different areas in the brain~     while a person performs tasks in which both what they see (visual input) and what they do~     (their motor response) are related or unrelated.~      Healthy, right-handed normal volunteers who are 18 years of age or older may be eligible for~     this study. Candidates are screened with a medical history, neurological examination and MRI~     scan, if one has not been done within a year of entering the study. MRI uses a magnetic field~     and radio waves to produce images of body tissues and organs. The subject lies on a table~     that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud~     knocking sounds that occur during scanning. The procedure lasts about 90 minutes, during~     which the subject is asked to lie still for up to 30 minutes at a time.~      Participants undergo fMRI for this 1-day study. fMRI differs from ordinary MRI in that the~     subject performs tasks during the scanning, allowing researchers to see brain changes that~     occur during performance of the activity. Before the scan, the subject is trained for the~     tasks, which include looking at shapes while following them with the fingers and looking at~     shapes without making finger movements. Following the testing, subjects have a second~     ordinary MRI scan.~   "
242787|NCT00376532|"~     Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular~     tachycardia or fibrillation in patients who have implantable cardioverter defibrillator~     devices.~   "
242788|NCT00376519|"~     RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body~     irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of~     cancer or abnormal cells and prepares the patient's bone marrow for the stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem~     cells may replace the patient's immune cells and help destroy any remaining cancer or~     abnormal cells (graft-versus-tumor effect). Giving an infusion of the donor's T-regulatory~     cells before the transplant may help increase this effect. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving cyclosporine~     and mycophenolate mofetil after the transplant may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects and best dose of umbilical cord~     blood T-regulatory cell infusion followed by donor umbilical cord blood transplant in~     treating patients with high-risk leukemia or other hematologic diseases.~   "
242789|NCT00376506|"~     This study will compare an implant with the technique of sensory training to determine which~     method may improve the ability to swallow and reduce the risk of choking. Many people with a~     brain injury or neurological disorders experience difficulty in swallowing. Past studies have~     shown that an electrical pulse applied to muscles or an increase in sensory stimulation to~     the throat can help.~      Patients ages 18 to 90 who have had a brain injury or neurological disorder and who have had~     trouble swallowing for 6 months or longer may be eligible for this study. Patients will~     undergo a physical examination, pregnancy test, and exam by a throat and speech physician.~     Fiber-optic endoscopic evaluation of swallowing with sensory testing involves a flexible tube~     passed through the nose to the back of the throat to allow observation of the voice box.~     Videofluoroscopy, an X-ray of the head and neck, will be done while patients swallow.~     Patients experiencing trouble with the upper esophagus may undergo additional procedures,~     including manometry to measure pressure changes in the back of the throat, and reevaluation~     through the fiber-optic tube. Patients in this study will have a magnetic resonance imaging~     (MRI) scan, which uses a strong magnetic field to obtain images of the body. Patients will~     lie on a table that slides into the enclosed tunnel of the scanner. The scan will take 20 to~     25 minutes.~      Patients will be assigned randomly to one of two groups: the intramuscular group, to have a~     stimulation device implanted in the neck, and the vibrotactile group, to receive a~     vibrotactile stimulator. All patients will have 10 training sessions with their devices, plus~     follow-up. Those patients in the first group will undergo surgery, under general anesthesia,~     for the implant. Three weeks following the implant procedure, patients will come to NIH to~     have the stimulator turned on and programmed and to learn how to use the device. Those~     patients in the second group will have about 2 to 3 weeks of training in using a vibrotactile~     device, and then they will take it home to use. All patients will return to NIH at 3 months~     to ensure proper use of the devices, and they will visit for follow-up at 6 months and 12~     months for tests and questionnaires.~   "
242790|NCT00376493|"~     Patients with infected abortion will be treated with dilatation and curettage, intravenous~     antibiotics. The purpose of this study is to verify if it is necessary to keep the use of~     oral antibiotics after hospital discharge.~   "
242791|NCT00376480|"~     RATIONALE: Giving total-body irradiation and chemotherapy, such as thiotepa and fludarabine,~     before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It~     also helps stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving methylprednisolone and antithymocyte globulin before transplant and peripheral blood~     cells that have been treated in the laboratory after transplant may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated~     peripheral blood cell infusion after donor stem cell transplant in treating patients with~     hematologic cancers or other diseases.~   "
242792|NCT00376467|"~     This proposal, developed in the framework of the GIMEMA, will permit:~        -  to evaluate the activity and toxicity of imatinib in the treatment of Ph+ acute~          lymphoblastic leukemia;~        -  to evaluate the molecular response to the treatment, and to monitor the molecular status~          of remission in all cases achieving or not a molecular response.~      The GIMEMA has activated a network to centralize all biological samples (bone marrow and~     peripheral blood) at diagnosis from all new ALL patients. This will permit to identify, in~     particular, Ph + and/or BCR/ABL + cases within 5 days from diagnosis, thus permitting to~     treat these patients according to different programs on the basis of the presence of Ph~     chromosome.~   "
242793|NCT00376454|"~     The purpose of this study was to determine the analgesic effect of GW493838 in patients with~     post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery.~   "
242794|NCT00376441|"~     Assess the outcomes of vaginal surgeries and its impact on sexual function and urinary~     symptoms.~   "
242796|NCT00376415|"~     Lessertia frutescens (L.) Goldblatt & J.C. Manning (syn. Sutherlandia frutescens (L.) R.~     Br.), infusions and decoctions are widely used in South Africa as indigenous medicines, to~     combat cancer, infections and symptoms associated with AIDS. The aim of this study was to~     evaluate the safety of this phytotherapy in healthy adults.~   "
242797|NCT00376402|"~     The World Health Organisation has warned that an influenza pandemic is inevitable. The avian~     influenza H5N1 virus strain is one of the leading candidates to cause the next influenza~     pandemic. The elderly are likely to be a special target group for vaccination; therefore,~     this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a~     healthy elderly population.~   "
242798|NCT00376376|"~     Single-dose studies of a fluoroquinolone are indicative of their antimicrobial activity since~     little accumulation occurs with multiple doses. Single-dose studies have been utilized to~     determine drug concentrations and time kill activity in serum, urine, and respiratory~     tissues.~      The purpose of this study is to evaluate the Urine Bactericidal Activity (UBA) of~     levofloxacin (250, 500, 750, and 1000 mg) against FQ-resistant, ESBL positive E. coli~     isolates. In addition, a susceptibility breakpoint concentration in the urine can also be~     established for each dose of levofloxacin. Furthermore, urine concentrations and serum~     pharmacokinetic parameters of levofloxacin can be determined.~   "
242799|NCT00376363|"~     The objective of this study is to compare the long-term safety and efficacy of the Ahmed and~     the Baerveldt implants in patients who are undergoing aqueous shunt implant surgery for~     glaucoma. One eye of eligible patients will be randomized. Outcome measures include~     intraocular pressure, visual acuity, visual field, number of glaucoma medications, glaucoma~     reoperations, and complications, including suprachoroidal hemorrhage, endophthalmitis,~     choroidal effusion, diplopia, corneal edema, and shunt/tube erosion.~   "
242800|NCT00376350|"~     This study will determine the number of visits to a chiropractor for spinal manipulation,~     light massage, and ultrasound necessary for optimal relief of chronic low back pain. The~     study will also determine the effectiveness of spinal manipulation.~   "
242801|NCT00376337|"~     To evaluate the efficacy and safety of micafungin in patients with proven invasive~     aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy.~     To compare the efficacy and safety of the micafungin therapy with the active control arm~   "
242802|NCT00376324|"~     Study to examine the concentration of the study drug, tigecycline, in human bone samples~     following the administration of multiple doses.~   "
242803|NCT00376311|"~     To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in~     patients suffering from osteoarthritis~   "
242804|NCT00376298|"~     The purpose of initiating the Urology Database is to evaluate the outcomes of urology~     procedures and medical management to enhance the care and treatment of urology patients.~   "
242805|NCT00376285|"~     The purpose of this study is to determine whether fenofibrate effects the toleration, safety,~     or efficacy biomarkers of CP-742,033, a drug being developed for the treatment of obesity.~   "
242806|NCT00376272|"~     Study purpose The purpose of the study is to show that the addition of valsartan on top of~     established therapies can reduce the recurrence of atrial fibrillation in patients with a~     history of recent atrial fibrillation associated with cardiovascular diseases/comorbidities.~      Primary objective To demonstrate that, in patients with history of recent atrial fibrillation~     treated with the best recommended therapies, the addition of valsartan 320 mg is superior to~     placebo in reducing atrial fibrillation recurrence.~      Study design The GISSI-AF is a prospective, multicenter, randomized, double blind, placebo~     controlled study. Patients with a history of atrial fibrillation will be centrally randomized~     in a 1:1 ratio to receive either valsartan or placebo.~      GISSI-AF will be a pragmatic trial, with broad selection criteria to mimic real clinical~     practice as much as possible. Since no special examinations or procedures are required for~     the trial, the economic impact on the National Health Service will be minimized and use of~     resources likely to be optimized. The enrollment period will last 12 months. The patients~     will be followed up for 12 months from study entry~      All prescribed treatments for AF or for the underlying cardiovascular diseases, including~     ACE-inhibitors, amiodarone and betablockers, will be allowed:~        -  patients should be on a stable treatment for at least one month~        -  the current guideline for hypertension treatment should be applied~        -  patients should not be started on ARBs during the study~   "
242807|NCT00376259|"~     This study is being conducted to compare the safety and effectiveness of the investigational~     medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently~     approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus~     [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination~     therapy will be compared to the results for patients taking adefovir alone.~   "
242808|NCT00376246|"~     The objective of this study is to show that Ezetimibe will improve endothelial function~     following high cholesterol meals in healthy subjects by decreasing absorption of cholesterol~     and thus affecting concentration and composition of remnant-like particles.~   "
242809|NCT00376233|"~     Increasing evidence suggests modulating effects of cannabinoids on time of onset, severity,~     and outcome of schizophrenia. Efforts to discover the underlying pathomechanism have led to~     the assumption of gene x environment interactions including premorbid genetical vulnerability~     and worsening effects of continuing cannabis use. For a main characteristic of psychoactive~     delta-9-tetrahydrocannabinol is its affinity to biological membranes, which are known to be~     disturbed in schizophrenia patients and genetic high-risk populations.~      Here we assess an hypothesised association between premorbid lipid disturbance and metabolic~     effects of external cannabinoids in schizophrenia.~      Intensity of niacin (methylnicotinate) skin flushing, indicating disturbed~     prostaglandin-mediated processes, is used as peripheral marker of lipid-arachidonic acid~     pathways and investigated in cannabis consuming and non-consuming schizophrenia patients and~     in healthy controls. Methylnicotinate is applied in three concentrations onto the forearm~     skin. Flush response is assessed in three minute intervals over 15 min using optical~     reflection spectroscopy.~   "
242855|NCT00375635|"~     The aim of this study is to examine removal of protein bound uremic substances by mFPSA in~     chronic hemodialysis patients. mFPSA is an extracorporal blood purification system developed~     for detoxification in acute liver failure by removal of protein bound as well as water~     soluble substances.~   "
242810|NCT00376220|"~     The Johns Hopkins Department of Psychiatry is conducting a research study to examine the~     effectiveness of riluzole in treating the depressed phase of bipolar disorder. This~     outpatient treatment study of medication or placebo will last 9-12 weeks. The study includes~     medical and psychiatric evaluations as well as time-limited medication treatment at no cost,~     and you will be compensated for your participation.~   "
242811|NCT00376207|"~     Decreased insulin sensitivity is and independent risk factor for stroke despite glycemic~     control. It is known that physical exercise increases insulin sensitivity in healthy~     subjects. Wether stroke patients can increase insulin sensitivity via physical exercise is~     not known.~      Chronic low-grade inflammation is associated with an increased risk of stroke. Physical~     exercise has shown to increase IL-6 directly after exercise in untrained subjects. When~     fitness is increased in each subject then the peak IL-6 concentration after exercise~     decreases and so does the basal level of IL-6. It is not known whether stroke patients can~     increase physical activity level to a degree where chronic inflammation are decreased.~      This study is designed to evaluate if physical exercise after stroke will increases insulin~     sensitivity and reduce low-grade chronic inflammation.~      Stroke patients have been randomized to intervention with physical exercise or control in the~     ExStroke pilot trial and followed for 2 years. Using the study population from the ExStroke~     pilot trail blood samples will be obtained at the last control. Insulin sensitivity can be~     measured from fasting glucose and insulin using the Homeostasis Model Assessment (HOMA).~     Interleukin-6, TNF-alfa and CRP is measured to estimate chronic inflammation.~   "
242812|NCT00376194|"~     This study will examine whether DMSA, an oral chelating agent that removes mercury and other~     metals from the body, is beneficial for children with autism. DMSA is commonly used to treat~     autism, although it has never been tested in a controlled study and there is no proof that it~     helps children with the disorder. Support for its use is based on single-case reports of~     benefits of chelation with DMSA. This study will help determine whether or not DMSA is useful~     for treating autism.~      Children between 4 and 10 years of age with autism spectrum disorder who weigh at least 33~     pounds, who have detectable, but not toxic, levels of mercury or lead in the blood, and who~     have not previously received chelation therapy may be eligible for this study.~      Participants complete a medical history, behavioral and psychological assessment and physical~     examination. Blood, hair, urine and stool samples are collected for testing.~      Because DMSA can remove minerals the body needs, such as zinc and iron, as well as the toxic~     lead and mercury, participants take a daily multivitamin supplement starting 1 month before~     beginning chelation therapy and continuing for the duration of treatment. After 1 month of~     the supplementation regimen, the children are assigned to receive DMSA or placebo for 12~     weeks, divided into six 2-week cycles. They take the assigned drug 3 times a day on days 1, 2~     and 3 of each cycle and continue the multivitamin every day.~      The children are seen in the clinic immediately before and after the first, third and sixth~     cycles. At each checkup, the parent or guardian answers a set of questions about the child's~     autism symptoms, physical health and medication side effects. Blood, urine and stool samples~     are collected for laboratory testing.~   "
242813|NCT00376181|"~     The purpose of this study is to evaluate the efficacy and safety of pioglitazone-azilsartan,~     once daily (QD), in subjects with type 2 diabetes mellitus with poor glycemic control.~   "
242814|NCT00376168|"~     Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the~     human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme~     glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in~     the cells of the monocyte-macrophage system.~      This is the second trial to utilize a recombinant active form of lysosomal enzyme,~     glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from~     transformed carrot plant root cell line.~   "
242815|NCT00376155|"~     Antimalarial chemoprophylaxis can reduce morbidity and mortality from malaria in children.~     However, this approach to malaria control has not been implemented widely because of concerns~     over its possible effect on the development of resistance and natural immunity. Intermittent~     preventive treatment (IPT) may be able to achieve some of the beneficial effects of~     chemoprophylaxis without its drawbacks. Recently, it has been shown that IPT given to~     Senegalese children under the age of five years on three occasions during the malaria~     transmission season reduced the incidence of clinical malaria by approximately 90%. However,~     it is uncertain how this intervention can be most effectively delivered. Therefore, 26~     Maternal and Child Health (MCH) trekking clinics in Upper River Division, south of the River~     Gambia, each with an average catchment population of 400-500 children under 5 years of age,~     will be randomly allocated to receive IPT from the MCH trekking team or from a IPT dispenser~     (village health worker, traditional birth attendant or a community mother based in a primary~     health care village). Treatment with a single dose of sulfadoxine /pyrimethamine (SP) plus~     three doses of amodiaquine will be given to all study subjects at monthly intervals on three~     occasions during the months of September, October and November. The primary end points will~     be the incidence of clinical attacks of malaria detected by passive case detection, and~     cost-effectiveness of the delivery methods. Important secondary endpoints will be the~     coverage and the equity of coverage of IPT in preventing malaria morbidity.~   "
242816|NCT00376142|"~     Using a theory-based approach, the purpose of this study is to identify modifiable factors~     underlying professional behaviour in order to identify those processes to target with an~     implementation intervention and to gain an understanding of how interventions might work and~     thus be optimised.~      Our principal objective is to develop interventions to change beliefs that have already been~     identified as antecedents to antibiotic prescribing for sore throats and then to~     experimentally evaluate these interventions to identify those which have the largest impact~     on behavioural intention~   "
242856|NCT00375622|"~     Hereditary hemorrhagic telangiectasia (HHT) is associated with recurrent epistaxis in 90% of~     cases. Good response to hormone treatment has been documented, although its use remains~     controversial. A double-blind placebo-controlled trial with estrogen treatment did not show~     any benefit over placebo. The aim of this study is to examine the efficacy of an~     antiestrogenic agent, TAMOXIFEN, in the treatment of HHT-associated epistaxis. The study will~     include up to 60 patients, over 18 years old.~   "
242857|NCT00375609|"~     Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the~     prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.~   "
242817|NCT00376129|"~     Protocol Title: Open-label,single center study to evaluate the savety and efficacy of an~     intramuscular 12 week-course of Alefacept in patients with atopic dermatitis.~      Study Phase: II~      Study Design: Open-label, single center Primary Study Objective: to determine the safety and~     efficacy of one course of Alefasept when administered as a 15 mg intramuscular ( IM)~     injektion to patients with atopic dermatitis~      Secondary Study Objective: to investigate key immunological parameters involved in the~     pathology of this common skin disease to interpret the clinical findings~      Number of patients: 10~      Study Population: Male and female patients, at least 18 years of age with atopic dermatitis,~     aktive inflammation, a severity score of 6-9 according to Langeland and Rajika and an EASI of~     >20~      Treatment Groups: Alefacept will be administered as a 15 mg IM injection once a week for 12~     weeks, followed by a 12-week follow-up period.~   "
242818|NCT00376116|"~     In spite of success in the management of heart failure, repetitive rehospitalisation and high~     mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have~     demonstrated that cardiac resynchronisation therapy (CRT) reduces mortality and~     rehospitalisation in heart failure patients. There is also evidence that telemonitoring of~     heart failure patients potentially reduces both mortality and morbidity. Recently, a Home~     Monitoring (HM) function has been integrated into BIOTRONIK CRT-defibrillators and~     CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote~     monitoring of heart failure patients. It is possible now to transmit predefined parameters on~     a daily basis from the implanted devices to a web-based platform accessible by patients'~     physicians. Our study evaluates clinical usefulness of Biotronik HM function in~     CRT-defibrillators and CRT-pacemakers.~   "
242819|NCT00376103|"~     The purpose of this study is to determine treatment related toxicity, tumor response,~     progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme~     (GBM) patients undergoing a combination of surgical resection, brachytherapy and external~     beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.~   "
242820|NCT00376090|"~     The purpose of this study is to determine the safety and the immune responses to the HIV~     vaccine candidate, MVA-CMDR. This vaccine was designed to induce immune responses to three~     HIV passenger genes encoded with the viral vector, MVA.~   "
242821|NCT00376077|"~     Childhood immune thrombocytopenia purpura (ITP) is a disorder characterized by the production~     of antibodies against platelets, resulting in enhanced destruction of platelets. Most~     children with ITP present with low platelet counts (PC) but minimal bleeding. Very rarely a~     child may present with a severe life-threatening bleed, such as a bleed in the head. In this~     case it is very important that the PC be raised as quickly as possible. The combination of~     corticosteroids and intravenous gammaglobulin (IVIG) is commonly used in the management of~     such severe bleeding in children with ITP to quickly raise the PC and yet this treatment~     combination has not been tested against using IVIG alone. If it is shown that the combination~     of these agents does result in a quicker rise in PC then when using IVIG alone would support~     the use of this combination therapy in emergency situations.~      As we can not ethically conduct this study in patients with life-threatening bleeds, we plan~     to study patients with ITP and PC less than 20 X 109/L, but without life threatening~     bleeding. Eligible patients will be randomized to one of these 2 regimens (IVIG + placebo or~     IVIG + IV corticosteroids). The study is designed as a double-blind trial, where the patient~     or the treating physician will not be aware of the regimen that a patient is randomized to.~     PC's will be measured as a surrogate measure of bleeding risk; bleeding scores (a score~     generated by observing patients for bleeding symptoms) will be used to grade bleeding~     severity, and adverse effects to treatment will be monitored by the means of questionnaires~     throughout the study.~   "
242822|NCT00376064|"~     This study will investigate the efficacy of a combination treatment with octreotide acetate~     and cabergoline in acromegalic patients that are only partially responsive to a somatostatin~     analog monotherapy~   "
242823|NCT00376051|"~     Frontotemporal lobar degeneration(FTLD) is a common cause of early-onset dementia. FTLD is~     characterized multiple behavioral symptoms including mental rigidity, irritability, emotional~     blunting, disinhibition, apathy, and aggression. These behavioural disturbances are~     particularly important because they increase caregiver burden and may lead to earlier~     institutionalization. While the causes of FTLD are largely unknown, there is a great deal of~     evidence suggesting that a brain chemical called serotonin regulates many of the behaviours~     that are disturbed in FTLD. Our objective is therefore to determine whether dysfunction in~     the brain's serotonin system is responsible for behavioural problems among FTLD patients. We~     hope to take the first steps towards a scientific understanding of the behavioural symptoms~     of FTD, and use our findings to support a larger study optimizing the treatment of targeted~     behavioural disturbances in FTLD using the antidepressant citalopram.~      Citalopram increases transmission by serotonin; we plan to use this medication to determine~     whether there are any differences in how the serotonin system functions in FTLD patients who~     display different levels of behavioural disturbances. Patients will be given citalopram and~     will have their blood drawn after 2 and 3 hours to determine plasma levels of the hormones~     cortisol and prolactin at those times. These hormones are good indicators of serotonergic~     functioning in the central nervous system.~      We expect that patients with lower levels of serotonergic functioning will have more severe~     behavioural disturbances and be less responsive to treatment with citalopram. Following their~     first test day, we will provide patients with a 6-week supply of citalopram, and assess them~     for any changes in behaviour at the end of this treatment.~      This study aims to obtain a better understanding of how changes in the serotonin system~     relate to behavioural symptoms in FTLD patients. Using the information from this pilot study,~     we can plan a larger study to determine whether certain behaviours will respond to treatment~     with citalopram, and if so, determine whether it is possible to predict which patients, based~     on individual characteristics, are most likely to respond to this treatment. This methodology~     will therefore not only provide a scientific rationale for treatment of FTLD, but also~     provide guidance for ongoing, individualized therapy.~   "
242824|NCT00376038|"~     GSK189075 is intended for use as a single treatment or in combination with other treatments~     for tye 2 diabetes mellitus (T2DM). Metformin is widely used in Europe and the USA for the~     treatment of T2DM. This study will evaluate the effect of GSK189075 on metformin levels in~     the blood in T2DM subjects. The rationale is to look for any safety problems that may result~     when the 2 drugs are given together.~   "
242825|NCT00376025|"~     The purpose of this study is to determine whether antioxidant supplementation can have a~     positive health effect on patients suffering from Kashin-Beck disease.~   "
242858|NCT00375596|"~     This study will evaluate the safety and efficacy of a new allergy medication~   "
242890|NCT00375167|"~     The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group~     intervention is an effective clinical tool to move a person with SMI along in their journey~     of recovery. The primary outcome measurements of this study will be the participants'~     perceived level of empowerment, hope and optimism, knowledge of recovery, and life~     satisfaction. This kind of information would add to the current body of knowledge about how~     principles of recovery can be used in psychoeducational programs used by outpatient community~     mental health services.~   "
242826|NCT00376012|"~     Title: Randomized clinical trial to assess the efficacy of short course intermittent regimens~     for the treatment of HIV-associated tuberculosis~      Phase: Phase III trial~      Population: 300 HIV positive patients with tuberculosis.~      Number of Sites:Four~        1. Tuberculosis Research Centre, Chennai~        2. Government General Hospital, Chennai~        3. Government Hospital of Thoracic Medicine, Tambaram~        4. Government Rajaji Hospital, Madurai~      Study Duration:36 months~      Study Objective:To study the efficacy of the standard RNTCP Category I regimen (2EHRZ3 /~     4RH3) the control arm vs. an extended continuation phase regimen 2EHRZ3 / 7 RH3 in the~     treatment of pulmonary and extrapulmonary TB in the HIV positive patients.~      2. To study the relationship between stage of HIV disease and response to anti-TB treatment.~      3. To study recurrences and their nature (relapse/re-infection) in detail by using RFLP~     analysis.~      Study Design:It is a two armed prospective randomized open label controlled clinical trial~     with stratified random allocation based on CD4 count and sputum smear grade.~      All enrolled patients will be treated according to the RNTCP guidelines during the intensive~     phase. In the continuation phase, Cat I patients will be stratified by CD4 counts and by~     smear grade, and randomly allocated either to the standard RNTCP regimen, or to an~     alternative extended regimen (2EHRZ3/4RH3 or 2EHRZ3/7RH3).~   "
242827|NCT00375999|"~     1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric~     cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic~     chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the~     Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response~     3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1~     as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks.~     4.Primary endpoints:~        1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid~          Tumors criteria, time to response, duration of response, and time to treatment failure.~        2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity~          Criteria for Adverse Effects (version 3.0).~   "
242828|NCT00375986|"~     The purpose of this study is to determine if there are differences in operative blood loss~     with manual vs. spontaneous removal of the placenta during cesarean section.~   "
242829|NCT00375973|"~     The purpose of this study is to determine the safety and efficacy of duloxetine compared with~     placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).~   "
242830|NCT00375960|"~     The objective of this study is to investigate the safety and efficacy of an investigational~     drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's~     feet and legs, or even in one's hands and arms, sometimes experienced by people with~     diabetes). An investigational drug is one that is not approved by the United States Food and~     Drug Administration (FDA) and/or Health Canada.~   "
242831|NCT00375947|"~     Participants in this study will do hand exercises once per day for 16 weeks. The purpose of~     the study is to determine if hand exercises designed to improve range of movement and~     strength are an effective way to decrease functional limitations for people with hand~     osteoarthritis. The study will also attempt to determine if pain and stiffness are improved,~     and if hand strength and dexterity are improved.~   "
242832|NCT00375934|"~     A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain~     following bunionectomy surgery.~   "
242833|NCT00375921|"~     Changes to taste and smell have been reported in head and neck cancer patients who undergo~     radiation and chemotherapy. This may cause food to be unappealing and can lead to a reduced~     food intake. Thsi study will increase our understanding of taste and smell changes and how it~     relates to food and taste preferences.~   "
242834|NCT00375908|"~     The investigators propose to compare the proteomic analysis of umbilical venous blood from~     neonates with brain injury to gestational age matched noninjured controls. After delivery an~     umbilical arterial gas and a 10 ml umbilical venous sample are obtained, then the remainder~     of the cord blood is discarded. The investigators plan to use this cord blood that would~     otherwise be discarded to perform our proteomic analysis. The investigators will use up to 20~     ml of cord blood per delivery. This will be a 5 year study during which time the~     investigators hope to analyze 450 infants at Johns Hopkins Hospital and Bayview Medical~     Center. The investigators will obtain an umbilical venous sample from infants born at < 34~     weeks gestation. For infants born at > 34 weeks the investigators will obtain an umbilical~     venous sample for any infant suspected to be at risk for neurologic injury by having a~     diagnosis of chorioamnionitis during labor, nonreassuring fetal heart rate tracing at the~     time of delivery, or a 5 minute Apgar < 7. For the infants born at < 34 weeks the brain~     injured infants will be compared to gestational age matched controls without brain injury.~     For the infants born at > 34 weeks, each infant later confirmed to have neurologic morbidity~     will be compared to a gestational age matched noninjured control. The investigators hope to~     use proteomic analysis to determine if there are measurable differences in protein expression~     between the 2 groups.~   "
242835|NCT00375895|"~     In France, 50% of hepatitis C virus carriers develop chronic clinical hepatitis, which may~     lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is~     constant after transplantation and recurrence causes chronic liver disease in 50 to 80% of~     cases. The aim of this study is to assess the efficacy of cyclosporin on C virological~     response. Patients included in the Transpeg 1 study and non-responder or with a recurrent~     disease will be switched from their tacrolimus therapy to cyclosporin, in association with a~     1 year peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the~     percentage of patients with a negative qualitative PCR after 19 months of cyclosporin~     treatment.~   "
242836|NCT00375882|"~     Hypothesis: Mild Hypothermia has a protective effect on residual hearing of patients~     undergoing cochlear implantation~   "
242837|NCT00375869|"~     The purpose of this study is to see if the treatment of severely brain injured patients with~     darbepoetin (a long acting form of erythropoietin) will be safe, and will reduce brain damage~     by decreasing harmful levels of chemicals in the brain.~   "
242886|NCT00375219|"~     To evaluate the safety and efficacy of subcutaneous administration of omacetaxine~     mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated,~     or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene~     mutation.~   "
242838|NCT00375856|"~     Primary Research Questions:~        1. Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a~          Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e.~          quality of life, function, range of motion) than similar patients who undergo total knee~          arthroplasty (TKA) using the Sigma fixed bearing knee?~        2. Do patients with knee OA who undergo TKA with a Sigma rotating platform have different~          knee kinetics and kinematics as measured by gait analysis than similar patients who~          undergo TKA using the Sigma fixed bearing knee?~        3. Do patients with knee OA who undergo TKA with or without computer assistance have better~          clinical outcomes at two years following surgery (quality of life, function, range of~          motion)?~        4. Do patients with knee OA who undergo TKA with or without computer assistance have~          different knee kinematics and kinetics as measured by gait analysis?~   "
242839|NCT00375843|"~     This study will examine how brain activity is affected by antidepressant treatment and how~     changes in brain activity relate to treatment response in people with depression.~   "
242840|NCT00375830|"~     This clinical trial studies sodium fluorine-18 (18F NaF)/fluorine-18 (18F) fluorodeoxyglucose~     (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in detecting~     skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate~     cancer. 18F NaF and 18F FDG are radioactive substances that are absorbed by cancerous cells~     and allow for the cancer to be found using diagnostic procedures such as PET/MRI. PET/MRI is~     a procedure that combines detailed pictures of areas inside the body from PET and MRI scans~     and may help find and diagnose skeletal metastases in patients with breast or prostate~     cancer. It is not yet known whether 18F NaF/18F FDG PET/MRI is better than standard imaging~     methods in detecting skeletal metastases.~   "
242841|NCT00375817|"~     To assess the efficacy and safety of MyoCell therapy on myocardial function in congestive~     heart failure patients, post-myocardial infarction~   "
242842|NCT00375804|"~     The objectives for this study:~        1. Investigate some of the causes for the racial disparity of endometrial cancer survival~          rates among black and white women~        2. Examine the biologic correlates of aggressive behavior such as estrogen receptor status,~          p53 and HER-2/neu overexpression, and aromatase activity~   "
242843|NCT00375791|"~     This is a phase 2 study of perifosine in patients with multiple myeloma. Patients will~     receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or~     urine-electrophoresis at least every 3 weeks.~   "
242844|NCT00375778|"~     Purpose of study: To investigate whether the NMDA antagonist Memantine has a substantial~     effect of brain metabolism in patients with Parkinson's disease (PD), using Positron Emission~     Tomography (PET).~      Background: Disturbances in brain metabolism is thought to contribute to degeneration of~     neurons in brain of PD patients. Production of toxic oxygen radicals and presence of too much~     excitatory neurotransmitter (glutamate) due to over activity is involved. These factors can~     theoretically be alleviated by memantine.~      Hypothesis: Memantine decreases metabolism in areas in PD brain known to be over-active.~     Decreases in cerebral blood flow and oxygen metabolism in these areas will be the consequence~     and this can be detected by PET.~   "
242845|NCT00375765|"~     Dutasteride is used in the treatment of benign prostate enlargement (BPH).It inhibits~     conversion of testosterone (T) into the more potent dihydrotestosterone (DHT) to stop~     prostate (and possibly prostate cancer) growth. DHT regulates the expression of certain genes~     in the prostate. The pharmacodynamics of DHT reduction in the prostate were never~     investigated until now, as every measurement would require prostate tissue retrieval, which~     is medically and ethically unacceptable. A recently developed test is able to quantitatively~     measure gene expression in prostate-borne cells, in urine sediments after prostate massage.~     By measuring this gene expression in patients using dutasteride, it has become possible to~     assess the pharmacodynamics of gene expression reduction, which is representative for the~     pharmacodynamics of DHT reduction. Repeated prostate tissue sampling has therefore become~     unnecessary. This newly gained knowledge will lead to a better understanding of the action of~     dutasteride and will possibly help improve treatment of symptomatic BPH (Benign Prostatic~     Hyperplasia) and PrCa (Prostate Cancer)in the future.~   "
242846|NCT00375752|"~     This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous~     infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal~     patients with hormone responsive breast cancer~   "
242847|NCT00375739|"~     The purpose of this study is to determine whether topical application of PEP005 is safe for~     the treatment of actinic keratoses.~   "
242848|NCT00375726|"~     Dengue fever, caused by dengue viruses, is a major health problem in the tropical and~     subtropical regions of the world. The purpose of this study is to test the safety of and~     immune response to a new dengue virus vaccine in healthy adults.~   "
242849|NCT00375713|"~     Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder~     rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the~     2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from~     dermatitis and eczema with pruritus symptoms~   "
242850|NCT00375700|"~     In this study, an oral nutrition supplement has been developed that take into consideration:~     the nutritional requirements, treatment side-effects and taste preferences of head and neck~     cancer patients; the acceptance of a supplement when experiencing radiation therapy~     side-effects; and the taste preferences of head and neck cancer patients which may affect the~     supplement intake. We hope to increase dietary intake during the last 2 weeks of radiation~     therapy.~   "
242851|NCT00375687|"~     The purpose of this study is to determine whether early hormonotherapy is effective in the~     treatment of high risk prostate cancer patients after radical prostatectomy.~   "
242852|NCT00375674|"~     To compare the disease free survival time and safety of sunitinib with placebo in adjuvant~     treatment patients at high risk of recurrent kidney cancer after surgery.~   "
242853|NCT00375661|"~     The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin~     therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had~     the curative resection of primary HCC.~   "
242854|NCT00375648|"~     This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered~     intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients~     with prostate cancer.~   "
242859|NCT00375583|"~     This study, conducted in Chennai, India, will determine whether a new treatment regimen of~     albendazole and diethylcarbamazine for lymphatic filariasis can eliminate the disease more~     quickly than the standard regimen. Lymphatic filariasis is caused by infection with very~     small filarial worms, particulalry Wuchereria bancroti, that are spread by mosquitoes. The~     infection can lead to swelling of the arms, legs, breast and scrotum and can progress to~     permanent swelling of the legs or arms called elephantiasis. The study will see if a higher~     and more frequent dose of albendazole is better at clearing filarial worms from the blood~     than the current treatment.~      Healthy people between 18 and 55 years of age who are in good health and who are infected~     with Wuchereria bancrofti may be eligible for this 28-month study. Candidates must be willing~     to spend 4 days in the Government General Hospital in Chennai, India, at the beginning of the~     study. They are screened with a medical history, a brief physical examination, ultrasound~     (picture generated by sound waves) of the groin or chest, and blood tests to check for~     infection with Wuchereria bancrofti and to measure white blood cell counts.~      Participants undergo the following procedures:~      -4-day hospitalization~      Random assignment to receive either standard treatment (400 mg albendazole and 300 mg DEC~     given once a year for 2 years) or the experimental regimen (800 mg albendazole and 300 mg DEC~     given twice a year for 2 years)~      Urine pregnancy test for women of childbearing age~      Receive first treatment dose~      Monitoring for symptoms~      -6-month outpatient visit~      Short history, physical examination and blood test~      Second treatment dose for subjects receiving 800 mg albendazole~      Urine pregnancy test for women of childbearing age~      -1-year outpatient visit~      Short history, physical examination and blood test~      Second or third treatment dose, depending on treatment group~      Repeat ultrasound in subjects whose first ultrasound detected adult worm~      Urine pregnancy test for women of childbearing age~      -18-month outpatient visit~      Short history, physical examination and blood test~      Fourth treatment dose for subjects receiving 800 mg albendazole~      Urine pregnancy test for women of childbearing age~      -24-month outpatient visit~      Short history, physical examination and blood test~      Final dose of albendazole and DEC at standard doses~      Repeat ultrasound in subjects whose first ultrasound detected adult worms~      Urine pregnancy test for women of childbearing age~   "
242860|NCT00375570|"~     The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent~     herpes labialis in adolescents.~   "
242861|NCT00375557|"~     The primary aim is to determine whether Divalproex ER or one of the atypical antipsychotics~     is more effective improving dementia related behavioral symptoms in patients with dementia,~     and evaluate the impact of such improvements on other clinical domains, such as quality of~     life, functional status.~   "
242862|NCT00375544|"~     This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC~     (LSLLC) phototherapy device for home (self) treatment of knee osteoarthritis (OA).~   "
242863|NCT00375531|"~     Objectives: The primary objective of this study is to conduct a randomized pilot study on the~     efficacy of Mindfulness Meditation (MfM) on sleep in post war Iraqi/Afghanistan veterans with~     PTSD. It is hypothesized that the change in sleep (measured by actigraphy), sleep self report~     measures, and PTSD symptoms (measured by the PTSD Checklist) from baseline, 8 weeks and 12~     weeks will be greater for veterans with PTSD who are treated with MfM, controlling for~     pretreatment values and other clinical and demographic factors.~      A secondary objective will investigate whether there is an improvement in psychological~     wellness (measured by optimism, perceived wellness, and spirituality) following MfM~     treatments.~      It is hypothesized that change in optimism, perceived wellness, and spirituality from~     baseline, 8 weeks and 12 weeks will improve in veterans with PTSD who are treated with MfM,~     controlling for pretreatment values and other clinical and demographic factors. Physiological~     measures of actigraphy in the home will be done at baseline, eight weeks, and twelve weeks.~     Subjective measure of sleep include measurements of sleep and quality of life(FOSQ) and~     subjective sleep quality (PSQI). Other self-report measures that will examine psychological~     wellness include the Life Orientation Test (LOT), the Perceived Wellness Survey (PWS) and the~     Spirituality Assessment Scale (SAS).~   "
242864|NCT00375518|"~     This study will compare atorvastatin (Lipitor) with a placebo (inactive pill) to see if this~     drug reduces heart rhythm abnormalities (arrhythmias) or lung inflammation after thoracic~     surgery. Preliminary results suggest that cholesterol lowering drugs (statins) may reduce~     problems after surgery such as arrhythmias or lung inflammation which may be serious. This~     study will be randomized and double blind, meaning that patients are placed in groups purely~     by chance, like flipping a coin. Neither the patient or doctor will know which group the~     patient is in.~   "
242865|NCT00375505|"~     This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months~     over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral~     density in premenopausal women with hormone receptor negative breast cancer and adjuvant~     chemotherapeutic treatment~   "
242866|NCT00375492|"~     This trial is designed to compare the effects of twice-daily exenatide and twice-daily~     placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2~     diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus~     a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their~     current oral antidiabetes agent regimen and participate in a lifestyle modification program.~   "
242867|NCT00375466|"~     In this study we will investigate whether tranexamic acid given as an intravenous bolus~     injection before start of surgery, followed by a continuous infusion during surgery reduces,~     perioperative hemostatic activation, and postoperative bleeding and the need for transfusions~     of blood components in elderly patients undergoing combined aortic valve replacement and~     coronary artery bypass surgery. Tranexamic acid will be compared with placebo (0.9% sodium~     chloride) in a randomized and double-blind study design.~      The study hypothesis is that tranexamic acid will reduce hemostatic activation and~     postoperative hemorrhage and the need for blood component transfusions in this group of~     patients.~   "
242868|NCT00375453|"~     This study will evaluate the safety and tolerability of SH U04722 in patients with solid~     tumor cancers. In addition, this study will identify the recommended dose and administration~     schedule of SH U04722 for phase II development in Japanese cancer patients, evaluate the~     pharmacokinetic profile of SH U04722 and gather preliminary data on the effectiveness of SH~     U04722 in patients with solid tumors.~   "
242869|NCT00375440|"~     The purpose of this study is to determine if tranexamic acid significantly reduces blood loss~     and blood transfusion in revision total hip replacement. Tranexamic acid is a drug that helps~     to reduce blood loss during surgery. Revision total hip replacement surgery is treatment for~     patients who have previously had hipe replacement surgery which failed and must be~     repaired/replaced.~   "
242870|NCT00375427|"~     The objective of this study is to assess the clinical benefit of two different dosing~     schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who~     have already been treated with zoledronic acid for about one year.~   "
242887|NCT00375206|"~     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where~     administrations are given and any effects it may have on subjects' wellbeing. The study will~     also test the ability of vaccine to cause particular immune responses in the body.~   "
242888|NCT00375193|"~     The purpose of the study is to evaluate the objective tumor response rate of amrubicin when~     administered as second-line therapy to ED-SCLC patients who have refractory or progressive~     disease.~   "
242871|NCT00375414|"~     Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics~     which may result in emergence of resistant micro-organisms like Methicillin resistant~     Staphylococcus aureus (MRSA). Introducer PEG technique avoids the sojourn of PEG catheter~     through the oropharynx so chances of infectious complications are negligible. It was not~     popular because of associated risks and complications. However the new introducer PEG~     gastropexy has been recently proved to be safe. To determine the incidence of peristomal~     wound infections during the immediate 7 day post procedure follow up period after the new~     introducer PEG gastropexy~   "
242872|NCT00375401|"~     The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in~     obese adults~   "
242873|NCT00375388|"~     The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to~     investigate the effects of metformin HCL in patients with type 2 diabetes mellitus~     intensively treated with insulin on the quality of the metabolic control of diabetes, the~     daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of~     microvascular and macrovascular complications, and on the qualify of life (Diabetes Health~     Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.~   "
242874|NCT00375375|"~     Minimal hepatic encephalopathy (MHE) has a negative effect on patients’ daily functioning. No~     study has so far investigated the effect of treatment related improvement in cognitive~     functions on health related quality-of-life (HRQOL). This study was carried out to determine~     the influence of treatment on psychomotor performance and on HRQOL in patients with MHE.~      The mean number of abnormal NP tests decreased significantly in patients in treated group~     compared with patients in untreated group MANOVA for time and treatment, P =.001). Mean total~     SIP score improved among patients in the treated group after 3 months compared with patients~     in untreated group after 3 months (MANOVA for time and treatment, P=.002). Improvement in~     HRQOL was related to the improvement in psychometry. In conclusion, treatment with lactulose~     improves both cognitive functions and HRQOL in cirrhotic patients with MHE.~   "
242875|NCT00375362|"~     Patients who undergo general anestheesia for total knee arthroplasty pften have sever~     postoperative pain which hinders their rehabilitation. Nitroglycerin patches have been found~     to cause alleviation of pain especially when used in conjuction with morphine. Therefore we~     propose placement of a nitroglycerin patch after total kneee arthroplasty surgery and see how~     it affects pain scores or causes less nedd for morphine after surgery.~   "
242876|NCT00375349|"~     Aim:~        1. To determine the prevalence of fatty liver in a cohort of patients hospitalized with~          chest pain in the Cardiology department.~        2. To assess the effect of statins on the prevalence of fatty liver by a cross sectional~          survey of patients hospitalized with chest pain.~   "
242877|NCT00375336|"~     The purpose of this study is~        -  to determine the degree of endothelial dysfunction and inflammation in calcific aortic~          valve disease associated with coronary artery disease(CAD).~        -  to determine whether there is relationship between calcium metabolism and calcific~          aortic valve disease associated with CAD.~   "
242878|NCT00375323|"~     The purpose of the study is to compare the effects of recombinant factor VIIa (NovoSeven) on~     restoring coagulation activation between patients with hemophilia A and antibodies to factor~     VIII and normal subjects (controls) by use of an in vivo method.~   "
242879|NCT00375310|"~     The purpose of this study is to evaluate the safety and tolerability of the combined~     treatment of Sorafenib (BAY 43-9006) with Gemcitabine and radiotherapy in patients with~     localized unresectable pancreatic cancer.~   "
242880|NCT00375297|"~     This prospective double-blind, placebo-controlled (DBPC) study, assessed the efficacy of~     sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual~     dysfunction (SRI-AASD) following the same protocol which previously established efficacy in~     men with SRI-AASD.~   "
242881|NCT00375284|"~     This trial is a 6-week, double-blind, randomized, active and placebo-controlled~     parallel-group study with a primary objective of comparison of starting doses of pramipexole~     fixed-dose (0.25 mg daily) and pramipexole titrated-dose (0.125 mg qd for 1 week, then 0.25~     mg qd for the remaining 5 weeks) with placebo to evaluate efficacy and safety in treating RLS~     symptoms in patients diagnosed with idiopathic RLS.~      The secondary objectives of this study will be to assess the onset of action of symptomatic~     relief of RLS for pramipexole with daily assessment of PGI and modified IRLS during two~     intervals of the first 2 weeks (Days 2, 3 and 4 and Days 9, 10, and 11) and assessment of~     IRLS, PGI and CGI-I at Weeks 1, 2, 4 and 6 (CGI-I additionally on Day 3).~   "
242882|NCT00375271|"~     The aim of this study is to evaluate different strategies of hemodynamic optimization in high~     risk surgical patients during the first twelve postoperative hours in ICU based on a protocol~     guided by a less invasive monitorig tool (Vigileo®), oriented by a fiberoptic central venous~     catheter that allows continuous monitorig of SvcO2 (PreSep®), and a pressure transducer~     (FloTrac®) that allows cardiac output calculation by the standard deviation of mean arterial~     pressure or a standard resuscitation strategy.~   "
242883|NCT00375258|"~     CRASH 2 is a large pragmatic randomised placebo controlled trial of the effects of the early~     administration of the antifibrinolytic agent tranexamic acid on death, vascular events and~     transfusion requirements. Adults with trauma who are within 8 hours of injury and have either~     significant haemorrhage, or who are considered to be at risk of significant haemorrhage, are~     eligible if the responsible doctor is for any reason substantially uncertain whether or not~     to use an antifibrinolytic agent. Numbered drug or placebo packs will be available in each~     participating emergency department. Randomisation will involve calling a 24-hour freecall~     randomisation service. The call should last only a minute or two and at the end of it the~     randomisation service will specify which numbered treatment pack to use. For hospitals where~     telephone randomisation is not feasible, randomisation will be by taking the next~     consecutively numbered treatment pack. No extra tests are required but a short form must be~     completed one month later or on discharge or on death (whichever occurs first).~   "
242884|NCT00375245|"~     The purpose of this study is to determine the highest safe dose of rapamycin when given with~     a fixed amount of grapefruit juice.~   "
242885|NCT00375232|"~     The purpose of this study is to determine if treatment of exercise-induced Bronchospasm with~     montelukast will help college athletes train more effectively and thus become more~     competitive in a non ergogenic manner.~   "
242891|NCT00375154|"~     The purpose of this study is determine if NPPV can be performed in a pre-hospital setting~     very early after onset of dyspnea with a similar benefit in need of intubation and mortality~     as in previous study in hospital context and if early NPPV intervention have a real, rather~     standard medical therapy, value, both on objectively measured parameters and on patient's~     clinical status.~   "
242892|NCT00375141|"~     The purpose of the trial is to compare clinical efficacy and occurrence of side effects in~     the treatment of photodamaged skin with Pulsed Dye Laser and Intense Pulsed Light.~   "
242893|NCT00375128|"~     This study examines the ability of two new malaria vaccines (FP9-PP and MVA-PP) to prevent~     the development of malaria infection after controlled exposure to the parasite. Volunteers~     for this trial will have received these vaccines in the preceding trial VAC027.1.~   "
242894|NCT00375115|"~     The trial will examine the efficacy of sambucol in the treatment of influenza. The primary~     efficacy endpoint will be the length of time to resolution of influenza illness.The double~     blind trial will be conducted at the Personnel Clinic, and at the Clinical virology Unit,~     Hadassah University Hospital, and will include 100 patients with laboratory-confirmed~     influenza infection, 50 in the sambucol and 50 in the placebo study arm.~   "
242895|NCT00375102|"~     This one-year pilot study has two specific aims: 1. to determine the feasibility of~     conducting a randomized controlled trial of acupuncture and the relaxation response for~     substance abuse among homeless veterans who are in a domiciliary care program, and 2. to~     collect and analyze pilot data to estimate the effect size for planning a future larger study~     to fully test the hypothesis of the effectiveness of acupuncture and the RR in reducing~     cravings for substances (alcohol and drugs), and the corollary effects on quality of life.~   "
242896|NCT00375089|"~     Prader-Willi syndrome (PWS) is a rare genetic disorder that affects about 1 in 14,000 people~     in the United States. As the most commonly identified genetic cause of obesity, PWS is often~     confused with Early-onset Morbid Obesity (EMO). Individuals with EMO show some signs of PWS,~     but clinically do not have PWS. The purpose of this study is to evaluate the clinical~     features and genetic basis of PWS and EMO, and to determine how these conditions affect a~     person throughout a lifetime.~   "
242897|NCT00375076|"~     In a prospective, randomized, double-blind trial, the effects of two different dosages of~     LMWH (5000 anti-Xa U od sc and 10 000 anti-Xa U od sc daily) on markers of hemostatic system~     and thrombin generation will be investigated in non-surgical cancer patients will be~     investigated.~   "
242898|NCT00375063|"~     Unprotected left main coronary artery (ULMCA) stenting, offering restoration of a native flow~     to left coronary artery, is the subject of intense investigations as a potential alternative~     to bypass surgery. The purpose of the study is to compare the short and long term results of~     unprotected left main stenting with coronary artery bypass surgery.~   "
242899|NCT00375050|"~     The proposed study would evaluate the benefits of riluzole add-on treatment to patients with~     schizophrenia who are already receiving medications, but still experience symptoms.~     Neuroprotective medication riluzole is currently approved for treatment of amyotrophic~     lateral sclerosis (Lou Gehrig's disease), a severe neurological illness. Due to its unique~     mechanism of action, riluzole, if effective in helping the symptoms of schizophrenia, would~     open novel directions in treatment of schizophrenia.~   "
242900|NCT00375037|"~     This randomized controlled trial will evaluate the effect of a multifaceted intervention~     including performance feedback on adherence to hand hygiene among healthcare workers. A key~     component of the study is to demonstrate whether improved adherence to hand hygiene leads to~     a reduction in rates of infection.~   "
242901|NCT00375024|"~     Patient Navigation is a Supportive Care Intervention that addresses barriers to quality~     standard care by providing individualized assistance to patients and families. The NCI is~     conducting several research programs to test the effectiveness of this approach. The expected~     outcomes of patient navigation through the cancer care system include:~        -  Timely, definitive diagnosis following an abnormal test~        -  Timely treatment following positive diagnosis~        -  Patient satisfaction with the diagnostic and care system experience~   "
242902|NCT00375011|"~     The three objectives of this trial are:~        1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will~          correlate with changes in CTP and MELD scores in patients with cirrhosis.~        2. To determine the critical value of hepatic metabolic function as measured by BreathID~          will predict which patients are at risk to develop complications of cirrhosis.~        3. To determine the critical value of hepatic metabolic function as measured by BreathID~          will predict which patients are at risk for liver related mortality.~      The hypothesis is that the BreathID breath test will correlate to CTP and MELD scores, and~     that thresholds can be established that will help predict risk of complications of cirrhosis~     and mortality.~   "
242903|NCT00374998|"~     This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers~     to determine their safety and ability to induce a measurable immune response against malaria.~   "
242904|NCT00374985|"~     The purpose of this study is to determine the dose limiting toxicity and the maximum~     tolerable dose of the radiochemotherapy with Docetaxel and Oxaliplatin in patients with~     adenocarcinoma of the gastric-oesophageal junction.~   "
242905|NCT00374972|"~     Objective: To determine and compare the effect of low dose estrogen combined hormonal~     contraceptives and progestin-only contraceptives on lactation.~      The subjects will be drawn from a healthy obstetric population in each center, where possible~     preliminary contact during antenatal period. At the postpartum visit, subjects that express~     their wish for a hormonal contraceptive method will be offered enrollment. After obtaining an~     informed consent the participants will be allocated according to their free wish to either~     receive a combined preparation containing 0.02 mg ethylestradiol and 0.15 mg desogestrel~     (Mercilon, Organon) or a progestin only pill containing 0.075 mg desogestrel (Cerazette,~     Organon). Demographic, habits and perinatal data will be collected and stored to analysis.~      Frequency and methods of observation: All women will be followed at 6 (baseline), 9 and 12~     weeks post - partum. Instruction will be given as to recording information on intercurrent~     disease, frequency of nursing and use of complementary formula supplements. Maternal BMI~     calculation ( weight/height2) will be obtained at first visit.~      The objective is to compare the capacity of the breast to secrete milk under standard~     conditions and evaluate the influence of different hormonal contraception means. Thus samples~     will be collected at 6 weeks (enrollment) and the 9 and 12 weeks visits. An Egnell pump will~     be used for a maximum of 20 minutes form from both breasts, simulating a regular breast~     feeding. A total of 10 ml aliquot will be taken for composition analysis and the rest will be~     offered to the infant. The milk volume/feeding will be estimated and expressed in ml/feeding~     and multiplied by the number of feedings reported.~      Outcome variables: Milk volume, infant growth at each visit and biochemical markers of milk~     analysis : lipid, casein and carbohydrate content~   "
242908|NCT00374933|"~     This is a new platform in non-myeloablative allogeneic stem cell transplantation to improve~     survival by harnessing the immunologic potential of donor T-cells to induce and maintain~     long-term remissions in patients with hematologic malignancies without undue toxicity. This~     study involves is the first study in humans directed at optimizing the graft vs leukemia~     effect by infusing activated T-cells from healthy donors prophylactically, months after~     recovery from the initial transplant. Investigators are studying whether the activation of~     donor cells prior to infusion will enhance the patient's ability to seek and destroy~     residual malignant cells while also helping the immune system to fight infection without~     increasing the immune reaction against the host.~   "
242909|NCT00374920|"~     The purpose of this study is to establish the potential of MEM 1003 as a safe and effective~     treatment for patients with an acute manic or mixed episode of bipolar disorder.~   "
242910|NCT00374907|"~     The purpose of this clinical research study is to learn whether Saxagliptin can improve the~     body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes~   "
242911|NCT00374894|"~     Lead poisoning remains a common disease among children despite successful public health~     efforts that reduced its prevalence.Our study was designed to test the hypothesis that~     lead-poisoning children (BLLs:100-440µg/L) who were given DMSA and multi-nutrients would have~     a greater fall than children of other groups at 12 weeks of follow-up.~   "
242912|NCT00374881|"~     Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low~     dose morphine analgesia.~   "
242913|NCT00374868|"~     To assess the anti-tumor activity, as measured by response rate to bi-weekly pemetrexed plus~     cisplatin, in chemo-naive patients with diagnosed metastatic or locally advanced~     (non-resectable) urothelial cancer.~   "
242914|NCT00374855|"~     The primary objective of this study is to test the hypothesis that LY518674, administered for~     6 weeks to patients with mild hypertension, reduces Systolic Blood Pressure, compared with~     placebo.~   "
242915|NCT00374842|"~     The purpose of this study is to evaluate the immunogenicity and the safety of candidate~     vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years~   "
242916|NCT00374829|"~     The study is a randomised controlled trial to evaluate the impact of a program using~     information technology (IT) and healthcare professional support in patients with high blood~     pressure (BP) compared to usual care. The program helps patients monitor their own BP and~     medication and keeps nurses,physicians and pharmacists informed while respecting patient~     confidentiality. The IT system links directly with the patient's pharmacy data. Using~     pharmacy data and responses to questions on compliance and BP control, the IT system provides~     appropriate counselling, telephone reminders, generates prescription refill and renewal~     reminder calls and monitors BP. The system reports compliance and self recorded BP~     measurements to healthcare providers and also links with a nurse. This is so that the nurse,~     the patient's doctor and pharmacist can help answer questions about medication and~     controlling high blood pressure.~      A total of 500 patients in Laval, Quebec will participate in the study. Half of the patients~     will have the program plus usual care and the other have usual care only. We hypothesize that~     the program will improve BP control by helping patients take their medication properly and by~     helping doctors ensure that the best strength and kinds of medication are used to control~     high blood pressure. We believe the program will achieve this by helping to improve~     communication between patients and healthcare providers, without adversely impacting quality~     of life. Additional sub-studies will determine if the program is cost effective and can be~     applied in real practice and if the program helps patients, doctors, pharmacists and nurses~     communicate better.~   "
242917|NCT00374803|"~     To determine the safety and efficacy of a new formulation of Myfortic in combination with~     tacrolimus and thymoglobulin.~   "
242918|NCT00374790|"~     The purpose of this study is to compare the efficacy of iron (12.5 mg as ferrous sulfate) and~     placebo given for 6 months in preventing the elevation of blood lead concentration in~     children 6-9 months of age.~   "
242919|NCT00374777|"~     A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo~     and nitrazepam as a comparative drug.~   "
242920|NCT00374764|"~     Hypotheses:~        1. Preschool children with autism spectrum disorders (ASDs) who undergo ABA treatment only~          will demonstrate significantly better outcomes compared to an age and severity matched~          control group without ABA treatment.~        2. Preschool children with ASDs who undergo ABA in combination with risperidone will~          demonstrate significantly better outcomes compared to age and severity matched children~          who are receiving ABA alone.~        3. Young age, cognitive development and attentional abilities at baseline will be~          predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.~        4. At baseline, children with ASDs will show significantly lower performances on measures~          of cognitive, neuropsychological, and socio-emotional functioning than age-matched~          typically developing controls.~   "
242921|NCT00374751|"~     Cancer cells may spread from the primary site to the vertebrae resulting in their deformity.~     The standard treatment for this case is removal of the cancer deposits in the vertebra and~     filling the induced cavity with a cement like substance.~      We are studying the effects (good or bad) of adding samarium (a radioactive substance) to the~     cement that is injected into the induced cavity.~   "
242922|NCT00374738|"~     Our specific aims are:~        1. To examine the efficacy of GIFT in improving MST-related clinical outcomes in women~          veterans~        2. To examine the effects of GIFT on fronto-limbic brain function and~        3. To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD.~   "
242923|NCT00374725|"~     In this trial we test the hypothesis that a probiotic containing Lactobacillus acidophilus~     and Lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.~   "
242936|NCT00374556|"~     This research is being done to evaluate the effects of a sleeping pill (eszopiclone,~     Lunesta)in patients with arthritis of the knee who also suffer from chronic insomnia. This~     study will test whether Lunesta improves sleep, pain sensitivity, and daytime symptoms in~     patients with knee pain.~   "
242937|NCT00374543|"~     This study proposes to examine the potential safety and efficacy of ziprasidone for patients~     with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of~     quality of life and resilience.~   "
242924|NCT00374712|"~     Patients with chronic kidney disease (CKD) and those with end-stage renal disease (ESRD)~     undergoing renal replacement therapies show elevated serum phosphate levels which predispose~     them to cardiovascular calcifications and high risks of death from cardiovascular diseases.~     However, in certain patients hyperphosphatemia is not related to dialysis insufficiency,~     excessive daily dietary phosphorus intake or high serum parathyroid hormone (PTH) levels,~     suggesting that other mechanisms could be involved. Transgenic mice lacking the klotho gene~     showed a phenotype which resembles that of dialyzed ESRD patients, in the sense that they~     have hyperphosphatemia, vascular calcifications, and a short lifespan. This study will~     analyze whether functional polymorphisms or variants in the human klotho gene are associated~     with hyperphosphatemia in these patients.~   "
242925|NCT00374699|"~     Peripheral T-cell lymphomas (PTCLs) are neoplasias from post-thymic T-cells at different~     stages of differentiation and are a heterogeneous group of malignancies which present with~     different morphological patterns, phenotypes, and clinical presentations.~      These tumours have a striking epidemiological distribution with a lower incidence in Western~     countries than in Asia. In Korea, PTCLs including T- or natural killer (NK)-cell lymphomas~     constitute approximately 25 to 35% of all non-Hodgkin's lymphomas. This incidence is quite~     similar to that of other Eastern Asian countries, including Japan, Hong Kong, and China.~      Recent studies suggest that the T-cell phenotype is an independent significant prognostic~     factor, with PTCLs having one of the lowest overall survival and failure-free survival rates.~     Based on the investigator's experience, the overall complete remission rate was 61.2% (95%~     confidence interval [CI]: 48.5-72.8%) and the 5-year probability of failure-free survival was~     33.5%. Median survival of all patients was 45 months (range 0-64+ months) and the 5-year~     probability of survival was 36.2%. Rassidakis et al. reported that expression of~     pro-apoptotic proteins BAX and BCL-XS, may explain the poor response of many types of PTCL to~     standard chemotherapy.~      To overcome such poor outcome, the optimal therapy for PTCLs remains to be defined. However,~     because of the rarity of the disease in Western countries, only a few trials have been~     reported.~      Bortezomib (Velcade) is a modified dipeptidyl boronic acid, and a reversible inhibitor of the~     chymotrypsin-like activity of the 26S proteosome. Bortezomib may induce tumor cell apoptosis~     or decreased bcl-2 associated drug resistance. Through phase II studies, single agent~     bortezomib in patients with relapsed indolent and mantle cell lymphomas showed its activity.~     And also preliminary data indicate that bortezomib can be safely administered in combination~     with dose adjusted etoposide, prednisolone, vincristine, cyclophosphamide and doxorubicin~     (EPOCH) chemotherapy. Therefore, it can be possible to improve the poor outcome of patients~     with PTCLs by a combination of cyclophosphamide, doxorubicin, vincristine, prednisolone~     (CHOP) with bortezomib as a first-line therapy.~      Primary Hypothesis: Based on the clinical trials and experimental data, bortezomib can~     overcome pro-apoptotic proteins BAX and BCL-XS induced drug resistance.~   "
242926|NCT00374686|"~     This is a study of prophylactic Vs preemptive oral valganciclovir for management of~     cytomegalovirus infection in adult renal transplant recipients looking at clinical and~     pharmacoeconomic outcomes~   "
242927|NCT00374673|"~     Objectives : To investigate the analgesic effects of repeated sessions of unilateral rTMS in~     patients with chronic pain syndrome due to fibromyalgia, IBS or burning mouth syndrome.~     Primary outcome will be numerical pain scores.~      Methods : The study will be randomized and performed in parallel groups and double blind~     versus sham stimulation, and will include 90 patients (45 patients per treatment arm). The~     randomization will be computerized and performed for each aetiological group separately. The~     rTMS will be performed on the left motor cortex, 5 consecutive days , then once a week during~     3 weeks then twice a month during 2 months, then once a month during 6 months. Clinical~     assessment will include an assessment of pain, quality of life, sleep, depression and~     anxiety, catastrophizing, and a neuropsychological evaluation.~      Conclusion : this study should allow to determine for the first time the long term efficacy~     and safety of rTMS in the treatment of dysfunctional or idiopathic chronic pain syndromes~     which are often refractory to conventional treatments.~   "
242928|NCT00374660|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate~     the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients~     with advanced solid tumors.~   "
242929|NCT00374647|"~     Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous~     calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained~     long-term on MMF and sirolimus.~   "
242930|NCT00374634|"~     The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given~     in individual doses, according to a nomogram we have constructed based on our results from a~     previous study, results in more patients maturing 2-3 follicles compared to standard dose.~   "
242931|NCT00374621|"~     The purpose of this study is to determine the efficacy and safety of the addition of~     intravaginal isosorbide mononitrate to an established protocol of oral misoprostol for~     cervical ripening and labor induction.~   "
242932|NCT00374608|"~     The purpose of this study is to evaluate the exercise capacity of patients with complete~     heart block who are chronically being paced from the right ventricle. Also, we hope to~     correlate the level of uncoordinated contraction with the patients exercise capacity. We will~     enroll patients with complete heart block as diagnosed by standard electrocardiographic means~     and now have a permanent pacemaker. All patients we approach for this study will receive an~     echocardiogram to assess their heart function. As part of the echocardiogram, they will also~     receive a Tissue Synchronization Imaging (TSI) evaluation to assess the level of~     uncoordinated contraction they have. The patients will then be subjected to a cardiac~     exercise stress test which will involve them running on a treadmill until they cannot~     continue while data is collected regarding their heart's response to exercise. All portions~     of the study are noninvasive, which means they work from probes and monitors outside the~     body.~   "
242933|NCT00374595|"~     Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated~     PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease~     progression after kidney transplant.~      The purpose of this study is to evaluate which traditional and nontraditional cardiovascular~     disease risk factors best predict progression of cardiovascular disease (CVD) using carotid~     intima media thickness performed by ultrasound, in kidney transplant patients.~   "
242934|NCT00374582|"~     The purpose of this research study is to see how effective bioelectric impedance analysis~     (BIA) is in determining body composition (the amount of fat versus muscle in the body) and~     nutritional status in patients with End Stage Liver Disease (ESLD)~   "
242935|NCT00374569|"~     One aim of this study was to find if there was a difference between balance and stability~     between elite level gymnasts and non-gymnasts. Another aim was to find if there was a~     relationship between dynamic posturographic scores associated with sway fatigue or~     adaptability and the ability to learn new gymnastic routines. The ultimate aim of the study~     was to improve gymnastic performance while reducing the probability of injury.~   "
242938|NCT00374530|"~     Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF,~     blood flow in the middle cerebral artery and diameter of superficial temporal artery and~     correlate that to known pathophysiology of headache to see if PGE2 is involved in headache~     pathophysiology.~   "
242939|NCT00374517|"~     This study will determine whether a drug called pimonidazole hydrochloride shows areas of low~     oxygen in tuberculosis (TB)-infected lungs. Pimonidazole is a low oxygen marker, an agent~     designed to find areas in the body that are not getting enough oxygen. If it is found that TB~     grows where oxygen is low, these results may help doctors decide what medicines would be most~     effective for treating TB.~      Patients 20 years of age or older who are scheduled for lung surgery at the National Masan~     Tuberculosis Hospital in Masan, Korea to treat their TB may be eligible for this study.~      Participants undergo the following procedures:~        -  Blood draw before surgery to test for hepatitis B and hepatitis C viruses.~        -  Pregnancy test for women who can become pregnant.~        -  Infusion of pimonidazole through a vein in the arm 24 hours before surgery. A part of~          the patient's lung is removed during surgery. This tissue is examined under a microscope~          for evidence of pimonidazole, which would indicate low oxygen.~        -  Blood sample collection during surgery and on the 7th and 14th days after surgery to~          check liver function.~   "
242940|NCT00374504|"~     The aim of this study is to evaluate a possible correlation between predictive precesarean~     section pain and development of postcaesarean section pain using the PM.~      Patients and Methods 46 healthy pregnant women scheduled for elective cesarean section is~     included after informed consent. The standard operation procedures included spinal~     anesthesia, paracetamol 1 g 8 hourly, diclofenac 50 mg 8 hourly and oxycontine 10 mg x 2.~     Morphine was used for break-through pain.~      Before cesarian section the threshold for sensory and pain were measured 3 times, and the~     average was used for analyses. After cesarian section a blinded midwife assess the pain at~     rest and during mobilization every 12th hours over 2 days score.~      Data was analyzed using AUC and non-parametric test, P < 0,05.~   "
242941|NCT00374491|"~     The purpose of the study is to evaluate the long term outcome of a poly L-lactic acid /~     β-tricalcium phosphate (BILOK) biodegradable interference fixation screw used for~     arthroscopic bone-patellar tendon-bone ACL reconstruction,to determine if these BILOK screws~     completely biodegrade as expected three years after implantation, and to determine whether~     there is bone ingrowth into the defect remaining after resorption of the BILOK screw.~   "
242942|NCT00374478|"~     The purpose of this study is to determine the effects of Transdermal scopolamine vs. placebo~     on ship navigation performance under simulated heavy sea conditions.~   "
242943|NCT00374465|"~     The aim of this study is to compare the effect of treatment with verapamil or carvedilol on~     long-term outcomes in stable, chronic heart failure secondary to non-ischemic cardiomyopathy.~   "
242944|NCT00374452|"~     This project is a VA HSR&D-funded Quality Enhancement Research Initiative (QUERI) project to~     translate into practice evidence about clinical management of primary hypertension. The~     project aims to contribute to quality improvement of care for patients with primary~     hypertension. The project implemented a clinical decision support (CDS) system for primary~     care clinicians and evaluated the implementation by studying the following: impact on the~     clinicians' prescribing and their patients' blood pressures; the clinician satisfaction with~     the CDS; and organizational factors in the implementation.~   "
242945|NCT00374439|"~     The purpose of this study is to evaluate the efficacy of a cognitive-behavioral vs. an~     interpersonal therapy program for preventing depressive symptoms in adolescents.~   "
242946|NCT00374426|"~     To study the effectiveness of sertraline (Zoloft) in treating depression in adults with~     diabetes. The study will also determine whether depressed diabetic patients who have~     successfully responded to sertraline (Zoloft) are more likely to have depression recur if the~     sertraline (Zoloft) is discontinued.~   "
242947|NCT00374413|"~     The purpose of this study is to show that the Kineflex|C Spinal System is no worse than~     conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level~     degenerative disc disease at any cervical level from C3 to C7.~   "
242948|NCT00374400|"~     The purpose of the protocol is to increase the number of living donor transplants by~     eliminating immune incompatibilities between donors and recipients through paired donation.~   "
242949|NCT00374387|"~     75 heterosexual women are asked to use 3 different types of contraception (Nuvaring, low-dose~     combination pill, minipill), each during 3 months. On a monthly basis, questionnaires are~     filled out about sexual desire and psychosocial, relational en sexual parameters. Also the~     sexual desire of the partner is questioned. On a three-monthly basis, blood samples are drawn~     to determine changes in hormonal parameters (one sample per product period).~      75 lesbian women are doing the same trial, but during an extra 3 months period, they are~     asked to have their natural menstrual cyclus as a control condition. Blood samples during~     these extra months will be drawn at the third or fourth day after start of the menses.~   "
242950|NCT00374374|"~     The purpose of this study is to determine whether a probiotic containing Lactobacillus~     Acidophilus and Lactobacillus Rhamnosus is effective as treatment for patients with active~     colonic Crohn's disease~   "
242951|NCT00374361|"~     This study is designed to determine whether there is a relationship between the way insulin~     and blood vessels work. The difference in the interaction between Caucasian and African~     American adolescents will also be examined. This may play a role in the differing rates of~     heart disease and diabetes between the two groups.~   "
242952|NCT00374348|"~     To evaluate the effectiveness of flexible doses (15-30mg) of Aripiprazole in the treatment of~     patients with schizophrenia and co-morbid symptoms of OCD in the outpatient setting. The~     overall effectiveness of Aripiprazole will be evaluated by use of the Brief Psychiatric~     Rating Scale(BPRS), Yale-Brown OCD scale and Clinical Global Impression-Improvement(CGI-I)~     scale.~   "
242953|NCT00374335|"~     This study will attempt to determine how common liver hemangiomas are in children with~     infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous~     hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus~     ultrasound results in children without hemangiomas. Other objectives of the study include~     identifying specific risk factors in patients who have liver hemangiomas and identifying risk~     factors in children with symptomatic liver hemangiomas.~   "
242954|NCT00374322|"~     This study was designed to evaluate and compare the safety and efficacy of an oral dual~     tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage~     ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant~     chemotherapy and have no clinical or radiographic evidence of disease.~   "
242955|NCT00374309|"~     This study will determine if an experimental vaccine to prevent Ebola virus infection is safe~     and what side effects, if any, it causes. Ebola virus infection may range from mild to~     severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can~     lead to death. The vaccine used in this study contains man-made genetic material similar to~     one part of the Ebola virus, which is designed to stimulate an immune response to the virus.~     The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola~     virus.~      Participants are assigned to one of three groups as they enter into the study. Of the first~     16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an~     inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12~     receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is~     safe, the final 12 people in the last group of 16 receive the highest study dose, and 4~     receive placebo. The vaccine is given as a single injection in the arm on the day of~     enrollment.~      Participants keep a diary for 5 days, recording their temperature, symptoms and any reaction~     at the injection site. They call a study nurse the day after vaccination to report how they~     feel, and they return to the clinic approximately six times for follow-up evaluations. These~     visits may include a check of vital signs, physical examination, blood and urine tests, or~     other medical tests if needed.~   "
242956|NCT00374296|"~     In this study, MGCD0103, a new anticancer drug under investigation, is given three times per~     week to elderly patients with previously untreated acute myelogenous leukemia/high risk~     myelodysplastic syndrome or adults with relapsed/refractory disease.~   "
242957|NCT00374283|"~     Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus~     nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and~     renal transplant biopsies of patients affected by polyomavirus.~   "
242958|NCT00374270|"~     About 22% of Canadians have high blood pressure, or hypertension. However, studies have shown~     that only 1 out of 5 people with hypertension have their blood pressure controlled.~      Diabetes is also an important risk factor for heart disease and stroke. About half of people~     with diabetes also have hypertension - a deadly combination. Studies have shown that only~     about 1 in 10 people with diabetes have their blood pressure controlled adequately - clearly~     something needs to be done to improve this.~      Heart disease, stroke, hypertension, and diabetes are conditions that occur in the community,~     so we need to explore innovative solutions that will work in the community. Pharmacists are~     well-placed in the community to help identify people with diabetes and hypertension. This has~     worked very well in previous studies in patients with high cholesterol levels. Pharmacists~     and nurses have complementary skills which, when working as a team, may help identify and~     better manage hypertension in people with diabetes.~      Our main objective is to test whether a community pharmacist and nurse team can improve blood~     pressure control in people with diabetes and hypertension.~   "
242959|NCT00374257|"~     The purpose of this trial is to find out how effective Narrow Band-Ultraviolet Light B~     (NB-UVB) phototherapy is in treating oral cGVHD. NB-UVB Phototherapy involves exposing the~     inside of the mouth to light of a particular spectrum (a specific wavelength of light, 311nm)~     of the ultraviolet band, called NB-UVB. It is known that narrow band ultraviolet light~     therapy can improve symptoms in patients with skin chronic GVHD.~   "
242960|NCT00374244|"~     This is a 12 week outpatient study for patients with schizophrenia who are on Clozapine, but~     continue to experience symptoms. The purpose of this project is to find out if small doses of~     pimozide (an antipsychotic medication, taken by mouth) will be helpful in reducing symptoms~     (such as hearing voices, having trouble in organizing your thoughts, lack of interest in life~     events and social activities), compared to placebo (an inactive substance, sugar pill),~     when added to clozapine in patients with schizophrenia.~      The participant will be asked to come in once a week to meet with the research staff and~     study doctor. The participant will continue to see your regular clinician during this study~     for all normal appointments. The participant will remain on your current medications~     throughout the study. During the study you will be randomly selected to be put on a small~     dose of Pimozide or placebo.~   "
242961|NCT00374231|"~     To determine the safety and efficacy of early corticosteroid discontinuation in liver~     transplant recipients more than 90 days post transplant, utilizing a combination of two drugs~     (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.~   "
242962|NCT00374218|"~     Weight gain is linked to a high consumption of soft-drinks and other beverages sweetened with~     high fructose corn syrup. Being overweight increases risk for diabetes and heart disease.~     These problems may be due to high blood glucose and insulin responses caused by high fructose~     corn syrup. Sucromalt is a sweetener which contains the same amount of carbohydrate at high~     fructose corn syrup, but causes lower glucose and insulin responses. The purpose of this~     study is to see if consuming soft-drinks and other foods sweetened with sucromalt instead of~     high fructose corn syrup will result in lower levels of blood glucose, insulin, cholesterol~     and other markers of risk. We are including in this study people who are overweight and~     normally consume soft-drinks because they are the ones most likely to benefit from this~     change.~   "
242963|NCT00374205|"~     The purpose of this study is to compare the effectiveness and safety of two Artemisinin~     Combination Therapies (ACTs) for the treatment of children with uncomplicated Plasmodium~     falciparum malaria~   "
242964|NCT00374192|"~     To examine the change in sleep patterns and mood symptoms in response to eszopiclone~     (Lunesta) using a double-blind placebo-controlled cross-over study design in perimenopausal~     and postmenopausal women who experience insomnia, mild depression and/or anxiety.~   "
242965|NCT00374179|"~     RATIONALE: CT-322 may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping~     blood flow to the cancer.~      PURPOSE: This phase I trial is studying the side effects of CT-322 in treating patients with~     advanced solid tumors or non-Hodgkin's lymphoma.~   "
242966|NCT00374166|"~     The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and~     100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with~     generalized anxiety disorder~   "
242968|NCT00374140|"~     This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001~     (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be~     administered orally at a dose of 10 mg daily.~   "
242969|NCT00374127|"~     The purpose of this study is to investigate whether or not marijuana blunts will produce~     comparable plasma THC levels as marijuana joints and if blunts will produce larger~     cardiovascular and subjective effects.~   "
242970|NCT00374114|"~     Ultrasonic surgical aspiration of the cervix may be an effective method of treating cervical~     dysplasia without compromising the integrity of the cervix in reproductive age women.~   "
242971|NCT00374101|"~     High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in~     bleeding peptic ulcers successfully treated by endoscopic therapy~   "
242972|NCT00374088|"~     The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as~     Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose,~     helps prevent heart dysfunction in the early postoperative period following congenital heart~     surgery. Children undergoing major heart surgery, such as the arterial switch operation,~     routinely develop temporary heart dysfunction in the first 12-24 hours after surgery. This~     heart dysfunction may be severe and contributes to an increased risk for death or prolonged~     hospitalization. Current standard treatments include intravenous medications such as~     dopamine, epinephrine, and vasopressin that support your child's blood pressure and heart~     function. Unfortunately, high doses of these medications have the potential to cause severe~     side effects including loss of fingers and toes, liver and kidney dysfunction, and heart~     rhythm abnormalities. Our goal is to find a way to reduce heart dysfunction after major heart~     surgery in order to promote a smoother postoperative period, and reduce the risks associated~     with heart operations in children.~   "
242973|NCT00374075|"~     This is an open label phase I/II clinical trial to assess safety, tolerability and potential~     effect on SMN mRNA and protein in vivo of a compound in which preliminary evidence supports a~     potential effect on SMN levels in vitro.~   "
242974|NCT00374062|"~     The goal of this study is to determine if relaxation therapy improves patient satisfaction~     with Mohs micrographic surgery.~   "
242975|NCT00374049|"~     The purpose of this study is to determine the effectiveness of a drug called Poly-ICLC, also~     known as HiltonolTM, in boosting the body's immune system's response to an experimental~     vaccine therapy (called the MUC-1 vaccine).~   "
242976|NCT00374036|"~     The purpose of this study is to compare the effectiveness of 2 different sequences of~     polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally~     advanced or metastatic.~   "
242977|NCT00374023|"~     Vitamin A deficiency in children is associated with increased mortality and morbidity due to~     respiratory tract and diarrhoeal infections. Vitamin A supplementation has been shown in some~     studies to reduce morbidity due to respiratory diseases. However, other studies to reduce~     could not document such benefit from vitamin A supplementation. The role of vitamin A on~     immunity in humans is not yet clear due to inconclusive results. To evaluate immune changes~     and compare those with of a known immunopotent agent like zinc, a randomised double blind~     study will be carried out in 1-3 year aged children without acute illness and wt/age between~     61% and 70% of NCHS standard. Baseline anthropometry and vitamin A status will be determined~     using MRDR test and immune status will be estimated. Each group consisting of 50 children~     will either receive vitamin A 200,000 IU over 7 days or 40 m elemental zinc daily for 7 days~     or both or placebo. After 8 weeks immunity test will be repeated. Immunity tests will include~     serum 1gA, 1gM, 1gG an lymphocyte simulation and 8 antigen multiple skin test. Undiminished~     children will be given measles vaccine and serum titre will be measured before and after~     supplementation. Vitamin A status will be estimated by MRDR test. Vitamin A2 will be given~     and 1ml blood sample will be collected after 5 hours to see the ratio of vitamin A1 and A2~     (<0.06 as cut off) as the modified relative dose response (MRDR test). Doses of vitamin A or~     zinc will be repeated at the completion of 2 month. The results will be compared between~     groups and within groups at baseline and after 6 weeks. The study will generate information~     which will help to examine the immune response of vitamin A therapy in children as an~     underlying factor for reduction in mortality or morbidity. The study will be completed within~     a year.~   "
242978|NCT00374010|"~     The specific aims are:~        1. to evaluate the feasibility and acceptability of PC-ACP among African American patients~          with End-stage Renal Disease and their surrogates and~        2. to examine preliminary effects of PC-ACP on patient and surrogate outcomes (patients'~          perceived quality of communication, surrogates' level of comfort in decision making for~          the patient, patients' difficulty in making choices, patient-surrogate congruence in~          goals of care, and patients' and surrogates' psychosocial/spiritual receptiveness) at~          one week following receipt of the intervention.~   "
242979|NCT00373997|"~     The purpose of the study is to determine whether patients with suspected Laryngopharyngeal~     reflux have inflammation and ultrastructural injury on their laryngeal biopsies.~   "
242980|NCT00373984|"~     Patients undergoing chest surgery (thoracotomy) often develop shoulder pain after their~     operation despite epidural pain control of the incision. We plan to study the incidence of~     this phenomenon in our institution to determine whether there are patterns that may predict~     those persons at highest risk of developing this type of pain. Further, we hope to determine~     whether newer surgical techniques have an impact on the development of this type of pain.~   "
242981|NCT00373971|"~     Malnutrition of elder orthopaedic patients leads to weight loss and loss of fat free mass.~     Changes in the individual’s nutritional status and body composition may adversely affect the~     patient’s postoperative level of activity.~      Aim. Thus, the purpose of the present study is to report changes in postoperative weight, FFM~     and functions vital to daily living in a group of elder orthopaedic patients that were~     actively involved in their nutritional care during the hospital stay.~   "
242982|NCT00373958|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the~     13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC)~     and to compare the immune response to concomitant vaccines administered with 13vPnC and~     7vPnC.~   "
243017|NCT00373503|"~     The purpose of this study is to investigate the interaction between marijuana and two~     potential treatment medications: lofexidine and oral THC, with the direct goal of using this~     information to improve marijuana treatment outcome.~   "
242983|NCT00373945|"~     This retrospective case-control study is being conducted to estimate the sensitivity of the~     pharmacogenetic marker, HLA-B*5701 for hypersensitivity to abacavir (ABC HSR). The~     specificity of the marker, and its association with ABC HSR, as measured by odds ratios and~     95% confidence intervals, will be evaluated as secondary endpoints. Cases will be defined in~     two ways - subjects who have clinically-suspected ABC HSR and a positive abacavir skin patch~     test reaction (CS-SPTPos) and subjects with clinically-suspected ABC HSR (CS-HSR), regardless~     of the results of skin patch testing. The study will include 40 CS-SPTPos Black cases matched~     with up to 200 abacavir-tolerant controls. In parallel, 40 CS-SPTPos White cases will be~     matched with up to 200 White controls. Some of the secondary analyses will use cases defined~     by clinical criteria alone (CS-HSR). Black and White subjects will be analyzed separately~     because of the differences in ABC HSR rates and in the carriage frequency of HLA-B*5701.~   "
242984|NCT00373932|"~     The purpose of this exploratory study is to determine the feasibility, acceptability, and~     efficacy of an exercise persistence intervention for patients with chronic obstructive~     pulmonary disease (COPD) following pulmonary rehabilitation (PR).~   "
242985|NCT00373919|"~     Cervical anastomotic leak is one of the most common complications after trans-hiatal~     esophagectomy.~      Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromycin~     will reduce leak occurrence.~      Design: This is a prospective, randomized, double blind, placebo controlled study.~      Number of patients: 30.~      Inclusion Criteria:~        -  Patients after trans-hiatal esophagectomy~      Exclusion Criteria:~        -  Allergy to erythromycin~        -  Use of phenothiazine~        -  QT prolongation~        -  Liver function test (LFT) abnormalities~        -  Myasthenia gravis~        -  Cardiomyopathy~   "
242986|NCT00373906|"~     Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP~     -eradication,or chemotherapy or radiation.~   "
242987|NCT00373893|"~     To determine the effects of Lidocaine patch on the pain and hyperalgesia induced by~     intradermal capsaicin~   "
242988|NCT00373880|"~     The purpose of this study is to investigate whether aripiprazole will decrease cocaine~     self-administration, subjective effects and cravings compared to placebo.~   "
242989|NCT00373867|"~     Low back pain is a very common problem and the most common cause of job-related disability.~     While some occurrences of low back pain disappear within a couple of days, other occurrences~     take much longer to resolve or lead to more serious conditions. The purpose of this study is~     to determine the effectiveness of two behavioral types of therapy in reducing future~     disability in people who are receiving physical therapy for low back pain and tend to fear~     and avoid pain.~   "
242990|NCT00373854|"~     Hypothesis: Low blood sugar (hypoglycemia) decreases function of the lining of the blood~     vessels in normal humans.~      This study is designed to explore how hypoglycemia affects the function of the blood vessel~     lining. This will be determined by measuring blood flow to the arm before and after occlusion~     of flow. Blood vessel function will be measured before induction of hypoglycemia, during~     insulin induced hypoglycemia, and after recovery from hypoglycemia. A second study will be~     done but without hypoglycemia.~   "
242991|NCT00373841|"~     The purpose of the study is to identify genetic and biologic markers that may predict the~     loss of lung function due to idiopathic pulmonary fibrosis. The studies will compare genetic~     and biologic markers of samples to changes in symptoms. The ultimate goal is to predict if or~     when patients are likely to experience a rapid decline in lung function due to disease~     progression.~   "
242992|NCT00373828|"~     The overall aim of the project is to evaluate diagnosis and treatment of chest pain~     originating from the musculoskeletal system. Specifically, we wish to investigate prevalence~     and character of such chest pain in a population of patients with acute chest pain, admitted~     to a university hospital based acute chest pain clinic, and undergoing evaluation of acute~     coronary syndrome (Part 1). Then, to test a manually-based treatment protocol to patients~     with diagnosed musculoskeletal chest pain in a randomized clinical trial (Part 2).~      The specific purpose of this study (Part 1) is to determine the exact number of patients with~     acute chest pain origination from the musculoskeletal system, and to describe their cardiac~     status with respect to ischemic heart disease. Further, we wish to evaluate the decision~     making process of the chiropractor.~   "
242993|NCT00373815|"~     The present protocol is a dose-finding and toxicity study in preparation of a randomised~     study comparing current standard treatment CSA/prednisolone with the new combination~     CSA/prednisolone/everolimus.~   "
242994|NCT00373802|"~     Drops of either saline or phenylephrine are placed in the nose of infants less than 12 months~     of age to determine if it helps them to breathe easier.~   "
242995|NCT00373789|"~     The purpose of this study is to see whether Botox A (injected into the bladder muscle) can~     improve symptoms of urge incontinence that has not improved with usual medical treatments.~   "
242996|NCT00373776|"~     This trial will study miltefosine as a treatment for mucosal leishmaniasis.~   "
242997|NCT00373763|"~     Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to~     lung underdevelopment. Clinical experience from prospective controlled non-randomized case~     series with fetoscopic tracheal balloon occlusion has seen improved survival rates in~     contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is~     to provide further evidence about the efficacy and safety of the prenatal interventional~     approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.~   "
242998|NCT00373750|"~     The purpose of this study is to determine whether an in-home, paraprofessional-delivered~     family strengthening curriculum entitled Family Spirit is effective at increasing parental~     competence, improving maternal outcomes and improving childhood outcomes in a sample of~     at-risk teen mothers living in four Native American reservation communities. The~     effectiveness of the Family Spirit curriculum will be determined by comparing outcomes of~     mothers who receive the intervention plus assisted transportation to prenatal and well baby~     visits (called Optimal Standardized Care) to mothers who receive only Optimal Standardized~     Care. Outcomes will be assessed at multiple intervals over the course of a 39-month study~     period.~   "
242999|NCT00373737|"~     This study aims to study the gene expression profiles of liver tumors to help us understand~     their biology, and to find new tumor and treatment markers for liver cancer.~   "
243001|NCT00373711|"~     The management of thyroid cancer patients with suspicion of recurrent disease based on~     rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body~     scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected.~     The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT~     may allow better identification of recurrent disease, thus allowing for more patients to be~     treated with I-131 as a curative attempt.~   "
243002|NCT00373698|"~     The study is an evaluation of a systemic intervention to enhance the delivery of care~     according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate~     objectives are to (1) implement three component model (3CM) in VA primary care clinics; and~     (2) evaluate the effects of 3CM on clinician behavior and patient outcomes. The long-term~     objectives are to generate information to support implementation research on the RESPECT~     model for treating PTSD in primary care and ultimately, the implementation of the model in~     VHA to provide care to veterans with PTSD.~   "
243003|NCT00373685|"~     This study investigates if Celebrex has a lower incident of Gastrointestinal Events than~     other NSAIDS in subjects with osteoarthritis.~   "
243004|NCT00373672|"~     This is a six week, double blind,placebo controlled study for patients with schizophrenia or~     schizoaffective disorder treated with an atypical antipsychotic for at least two months.~     Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current~     antipsychotic and tested at baseline and week 6 for differences in memory, attention and~     problem-solving ability. Changes in weight during the six week study will also be tracked.~   "
243005|NCT00373659|"~     This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab~     for the treatment of patients with neovascular age-related macular degeneration (AMD) in the~     Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular~     Ranibizumab (PrONTO) study.~   "
243006|NCT00373646|"~     The purpose of this study is to evaluate Thalidomide for treatment of disseminated MALT~     Lymphoma or at relapse following helicobacter pylori (HP) - eradication or chemotherapy or~     radiation.~   "
243007|NCT00373633|"~     We will compare thoracic epidural anesthesia which is presently used for management of pain~     after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study~     wil be double blinded and prospective.~   "
243008|NCT00373620|"~     The purpose of this study is to determine whether post-operative concurrent chemoradiation~     with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial~     cancer patients.~   "
243009|NCT00373607|"~     In Peru, Mefloquine plus Artesunate (MAS3), is the current first line treatment for P.~     falciparum malaria in the Amazonian Region, and has proved its efficacy against~     multi-resistant P. falciparum parasites, but several side effects have been reported.~     Dihydroartemisinin-piperaquine (DHA-PPQ) is a new co-formulated and well tolerated ACT,~     increasingly used in Southeast Asia where it has proved to be highly effective against~     Plasmodium falciparum malaria. We tested the efficacy, safety and tolerability of DHA-PPQ in~     patients with uncomplicated P. falciparum malaria. A RCT to evaluate DHA-PPQ was carried out,~     between 2003 and 2005. Patients with uncomplicated P. falciparum malaria were randomly~     allocated to receive either DHA-PPQ or MAS3 with a 63-day follow-up period. Five hundred~     twenty two patients were included in the analysis, 262 were allocated to receive DHA-PPQ, and~     260 to receive MAS3. The two groups were comparable at baseline in demographic and clinical~     characteristics. The mean time for parasite clearance into the DHA-PPQ group was 32.0 hours~     and 35.5 hours in the MAS3 group. Twenty-four hours after the first dose, the proportions of~     patients whose cleared parasitaemia were 67.2% in the DHA-PPQ group, and 58.1% in the MAS3~     group (RR 1.25, [95% CI 1.03−1.52], p = 0.017). All patients were able to clear parasites~     within 72 hours after the first dose. The mean time for fever clearance was 28.0 and 29.5~     hours in DHA-PPQ and MAS3 group respectively. (P= 0.69). Twenty-four hours after the first~     dose, 85.5% and 83.1% of patients cleared fever in the DHA-PPQ and MAS3 group respectively~     (p>0.05). The Adequate Clinical and Parasitological Response (ACPR), PCR adjusted, were 97.7%~     and 99,2% for the DHA-PPQ and MAS3 group respectively, (RR 0.99, 95% CI [0.86−1.13], P =~     0.88). No Early Treatments Failures were reported in any group. In the DHA-PPQ group,~     according to the PCR adjusted results, 6 subjects had Late treatment Failures. In the MAS3~     group, two Late Treatment Failures was reported. The frequency of adverse events was~     significantly lower in patients treated with DHA-PPQ than in those treated with MAS3.~      DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P. falciparum~     malaria and suitable for use in the Peruvian Amazon region. It also has the advantage of~     being better tolerated. In terms of cost, DHA-PPQ is cheaper and more affordable than MAS3~     and should be considered for the National Antimalarial Drug Policy in Perú.~   "
243010|NCT00373594|"~     Chronic cold agglutinin disease (CAD) is a type of autoimmune hemolytic anemia (anemia due to~     destruction of red blood cells by abnormal antibodies). Almost all patients also suffer from~     cold-induced disturbances of blood circulation. The purpose of this study is to assess the~     efficacy and safety of combination therapy with rituximab (an antibody against B lymphocytes)~     and fludarabine (a cytotoxic drug) for CAD. Another aim is to try to assess whether these~     agents in combination are better than single agent therapy with rituximab.~   "
243011|NCT00373581|"~     The objective of this study is to determine if vigabatrin will decrease cocaine~     self-administration, cardiovascular effects, subjective effects and craving compared to~     placebo.~   "
243012|NCT00373568|"~     Miltefosine (longer course) will be used to try to improve the cure rate of mucosal~     leishmaniasis~   "
243013|NCT00373555|"~     Sarcoidosis is a benign, inflammatory condition which will typically involve the lungs and~     lymph glands in the chest. Diagnosis is often confirmed with bronchoscopic biopsy. A new~     method of performing bronchoscopic biopsy of lymph glands in the chest has now been developed~     which uses real-time endobronchial ultrasonography to better locate the lymph glands. While~     this technique has been proven to be effective in the diagnosis and staging of lung~     malignancy, its sensitivity for the diagnosis of sarcoidosis is unclear as smaller samples~     are obtained compared to the standard approach. This study will aim to randomize 50 patients~     with a clinical suspicion of sarcoidosis to standard biopsy vs. endobronchial ultrasound~     guided biopsy of the mediastinal lymph glands in order to compare the sensitivity of these~     tests for sarcoidosis.~   "
243014|NCT00373542|"~     The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the~     treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period~     limb movements during sleep.~   "
243015|NCT00373529|"~     Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the~     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia~     (ALL) who have had at least 2 prior treatment regimens.~      This study will evaluate the efficacy of clofarabine in elderly patients with acute~     myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive~     chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients~     with AML.~   "
243016|NCT00373516|"~     The purpose of this study is to evaluate the efficacy and safety of two dosing regimens of~     QRX-101 ointment (75 mcg/g QD and 75mcg/g BID) in the treatment of plaque-type psoriasis when~     applied topically twice daily for 8 weeks~   "
243019|NCT00373477|"~     This project will enable the investigators to conduct a randomized clinical trial to~     demonstrate the value of generalist care managers in the treatment of depression in Medicaid~     patients seen in primary health care practices. Depressed patients will be recruited at two~     primary care practices in Western North Carolina and randomly assigned to either generalist~     care management or usual care. Patients in each condition will be assessed at baseline and~     six months follow-up. Outcomes will include depressive symptoms, level of functioning, and~     cost-effectiveness measures.~   "
243020|NCT00373464|"~     The aim of this trial is to compare if a single dose of oral etoricoxib 120 mg will have~     equal post-operative analgesic efficacy as an optimal regiment of intravenous ketorolac 30 mg~     + 30 mg during the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical~     procedures, where the need for post-operative opioid is expected.~   "
243021|NCT00373451|"~     The purpose of this study is to determine which of these anti-clotting medications, abciximab~     plus unfractionated heparin or bivalirudin, is more effective to prevent thrombotic and~     bleeding complications in patients suffering from a heart attack and undergoing coronary~     intervention.~   "
243022|NCT00373438|"~     Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung~     failure due to lung underdevelopment and pulmonary hypertension. In severe cases,~     extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to~     enable survival of severely affected infants.~      Clinical experience from prospective controlled non-randomized case series with fetoscopic~     tracheal balloon occlusion has seen improved survival rates in contrast to untreated~     controls.~      Therefore, the purpose of this randomized clinical trial in a less severely affected subgroup~     of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive~     care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO~     therapy.~   "
243023|NCT00373425|"~     This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill~     following complete surgical removal of the tumor with or without chemotherapy after surgery~     in Stage IB-IIIA NSCLC patients.~   "
243024|NCT00373412|"~     Objectives of this trial are to:~      Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne challenge~     (3000 pfu) in healthy CMV-seronegative volunteers who receive VCL CT02 administered (1 mg~     weekly x 3) 3 months previously compared to randomized controls who do not receive VCL CT02~     as measured by:~        1. antibody titers for gB;~        2. T-cell IFN-g ELISPOT;~        3. T-cell proliferation assays for IE1, pp65, and/or gB; and~        4. cytokine and phenotypic flow cytometry responses to pp65, IE1, and/or gB.~      Evaluate the safety safety of Towne challenge in healthy CMV-seronegative adult subjects who~     have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02) administered~     intramuscularly.~      Our hypothesis is that the immune response to Towne vaccine 3000 pfu challenge after VLC-CT02~     priming will be greater than that after Towne vaccination alone.~   "
243025|NCT00373399|"~     The purpose of this study is to investigate the effects of smoked marijuana on both risk~     taking and decision making tasks.~   "
243026|NCT00373386|"~     Objective: This study is designed to determine whether growth hormone treatment in children 8~     to 18 years of age alters function of the lining of the arteries. This may play a role in~     increasing or decreasing the risk of heart disease.~      Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be~     studied before and 3 months after starting growth hormone. Subjects can be on other hormonal~     replacements but no other medications.~      Each study will be done in the fasting state. The blood vessel function will be determined by~     measuring the change in forearm blood flow before and after blocking flow to the arm for 5~     minutes. Blood will be drawn after the test to measure glucose, insulin and fats.~   "
243027|NCT00373373|"~     The primary purpose of the study is to determine, whether the addition of Sorafenib to~     standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results~     (event free survival).~   "
243028|NCT00373360|"~     The purpose of this 8-week study is to compare the effects of switching from therapy with~     epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing~     to Remodulin will have on patient satisfaction with their treatment and impact on quality of~     life.~   "
243029|NCT00373347|"~     The aim of the study is to see if there any changes in the quality of life for patients that~     are undergoing radical prostatectomy.~   "
243030|NCT00373334|"~     The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid~     Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in~     infants age 30 days up to 1 year.~   "
243031|NCT00373308|"~     This study will utilize the Expanded Prostate Cancer Index Composite questionnaire to learn~     what impact the surgery has upon the participant's sense of health, sexual and urinary~     quality of life.~   "
243032|NCT00373295|"~     The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's~     direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.~   "
243033|NCT00373282|"~     To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of~     surgery for PVR.~   "
243034|NCT00373269|"~     Between twenty and fifty percent of people who have acute stroke have hyperglycemia (high~     blood sugar) with it. The purpose of this study is to examine the relationships between~     diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and~     plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic~     patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.~   "
243035|NCT00373256|"~     To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to~     determine which treatment works better against breast cancer~   "
243036|NCT00373243|"~     This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in~     subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The~     hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381.~     Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing.~     Subjects will be housed from the evening before dosing until 24 hours after dosing. A~     follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.~   "
243037|NCT00373230|"~     Obesity has reached epidemic proportions with nearly two-thirds of the US population either~     overweight or obese. Thus, novel strategies that both improve weight loss maintenance and are~     accessible to those most in need are the focus of this application, which will determine if a~     telemedicine system can help participants, who have undergone a weight loss program based in~     church and community centers, maintain their weight loss over a 1 year period. Telemedicine~     will provide support through self-monitoring, education, supervised chat room, bulletin~     board, and e-mail.~   "
243038|NCT00373217|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed. Giving vaccine therapy and chemotherapy~     after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with~     paclitaxel and carboplatin works in treating patients who are undergoing surgery for stage~     III or stage IV ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.~   "
243039|NCT00373204|"~     The purpose of this study is to determine if the addition of motexafin gadolinium (study~     drug) to standard treatment with docetaxel will improve the response rate in patients with~     non-small cell lung cancer.~   "
243040|NCT00373191|"~     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the~     laboratory may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at the effects of surgery, radiation therapy,~     chemotherapy, and hormone therapy on biomarkers in women with stage I, stage II, stage III~     breast cancer, or ductal carcinoma in situ that can be removed by surgery.~   "
243041|NCT00373178|"~     The aim of the present study is to investigate the influence of several anti-diabetic~     regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in~     patients with recently diagnosed type 2 diabetes.~   "
243042|NCT00373165|"~     Study Phase: IV~      Study Type: Open-label, multicenter, randomised clinical trial with two arms stratified for~     an intensified immunosuppressive regimen in patients at high risk for acute rejection.~      Study Description: 148 kidney transplant recipients at risk for CMV disease were randomized~     and treated with ganciclovir capsules for 3 months (Group A, prophylaxis, N=74) or received~     ganciclovir IV only in case of proven CMV viral load (Group B, preemptive therapy, N=74).~     Initially, a 2 months follow up was planned in this trial. However, the study group decided~     to offer a longterm follow up to all patients and amended the protocol, respectively.~      The aim of the study was to identify the most efficacious way to prevent renal transplant~     recipients from CMV disease and to find out, if one of these two strategies may increase~     graft or patient survival. Therefore, both wellknown approaches of CMV prevention were~     compared in two study groups:~      Prophylaxis (Group A): Oral primary prophylaxis with ganciclovir capsules was started~     directly after transplantation and performed until day 90. In case of CMV infection (proven~     CMV viral load) or symptomatic CMV disease, treatment with ganciclovir IV was initiated.~      Preemptive Therapy (Group B): No oral primary prophylaxis was given. Treatment with~     ganciclovir IV was given to patients with proven CMV viral load (CMV infection or CMV~     disease) only.~   "
243043|NCT00373152|"~     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor~     cells. Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning~     how well radiofrequency ablation works to kill breast cancer cells and help doctors predict~     whether breast cancer cells remain after treatment.~      PURPOSE: This phase II trial is studying how well MRI works in predicting tumor response~     after radiofrequency ablation in women with invasive breast cancer.~   "
243044|NCT00373139|"~     It is common practice in the emergency medicine department to rapidly assess pregnancy status~     through the use of either urine or serum in pregnancy tests. Using whole blood instead of~     urine would facilitate a much more rapid emergency department identification of pregnancy~     status. No study to date has utilized whole blood for rapid detection of pregnancy status.~     Set in the busy adult emergency room at Maimonides Medical Center, this study will recruit a~     sample of women of reproductive age (18-55), who fit the inclusion criteria of being healthy~     and in need of a pregnancy test for own purpose or diagnostic testing/treatment. Blood~     samples will be taken from the participants and used in the hCG kits and the remaining blood~     was sent to the chemistry laboratory to perform the reference gold standard. The reference~     gold standard for a positive test is an hCG level >25mlU/ml. The research investigators and~     lab will be blinded to each other's results. Kappa statistics will be done for the~     measurement agreement between urine pregnancy results and whole blood pregnancy results, and~     whole blood results with laboratory results.~   "
243045|NCT00373126|"~     It has been suggested that patients with schizophrenia smoke in order to produce amelioration~     of dysfunctional dopaminergic pathways allowing them to experience pleasure and satisfaction~     and overcome anhedonia. No studies have assessed the effects of nicotine withdrawal on reward~     responsivity in patients with schizophrenia. The investigators believe that an understanding~     of this is crucial if improved treatments for nicotine dependence are to be developed for~     this patient population. If this group already has deficits in reward responsivity as a~     symptom of the disease then they may be particularly prone to the effects of nicotine~     withdrawal on reward systems. Smoking cessation may lead to a further decrease in their~     responsivity to pleasurable stimuli and worsening anhedonia. Treatments for smoking cessation~     may need to ameliorate any increased deficits if they are likely to be effective in patients~     with schizophrenia.~   "
243046|NCT00373113|"~     To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast~     cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a~     taxane and for whom further anthracycline therapy is not indicated~   "
243128|NCT00372021|"~     Non-arthritic anterior ischemic optic neuropathy is the most common cause of sudden visual~     loss due to optic nerve involvement in patients above 50 years old. As this problem can be~     considered as a sclera out let syndrome an there is no effective and successful treatment for~     it, we decided to do a neurotomy procedure and relax the involved optic nerve in order to~     achieve acceptable treating outcome.~   "
243047|NCT00373100|"~     Pneumonia is a leading cause of morbidity and mortality in children in developing countries.~     Zinc deficiency leads to impairment in tissue repair and immunodeficiency in children.At~     least two randomised controlled trials have shown that zinc supplementation improves the~     outcome of severe pneumonia in children (reducing duration of hospital stay and complications~     related to pneumonia).~      However, there are conflicting results from other randomised controlled trials about its~     efficacy in children with pneumonia.The purpose of the current study is to determine the~     efficacy of zinc as adjunct therapy for in severe pneumonia in children aged 6-59 months. We~     hypothesize that the proportion of children who recover from severe pneumonia following zinc~     adjunct therapy [(10 mg once daily for seven days) for children aged <12 months and 20 mg~     daily for children aged ≥12 months]will be higher than the proportion of children who recover~     from placebo therapy.~   "
243048|NCT00373087|"~     Entacapone is an antiparkinsonian drug which block L-dopa metabolism, inhibiting the~     C-O-methyltransferase (COMT) enzyme. There is an individual variability of the COMT activity~     determined by a genetic polymorphism. The aim of this study is to investigate whether the~     genetic variability influences entacapone efficacy in Parkinson's disease.~   "
243049|NCT00373074|"~     The purpose of this study is to address the question, What is the volume of blood for~     injection at epidural blood patch that most effectively relieves post-dural puncture~     headache?~   "
243050|NCT00373061|"~     The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain~     data on pregnancy outcomes in women who are exposed to Xolair®. Women exposed to at least one~     dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will~     be followed to completion of their pregnancies. The evaluation of infants will be conducted~     at birth and at 6-month intervals until the infants are 12 months old. Follow-up of the~     infant will be extended until the infant is 18 months old, if the woman continues Xolair®~     treatment while breastfeeding.~   "
243051|NCT00373048|"~     This is a randomized placebo controlled trial. Malaria chemoprophylaxis with mefloquine in~     asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya, Zambia will~     be compared to a placebo control group and followed up for 18 months.~   "
243052|NCT00373035|"~     RATIONALE: Collecting and storing samples of blood and urine from patients with cancer to~     study in the laboratory may help doctors learn more about changes that may occur in DNA and~     identify biomarkers related to cancer.~      PURPOSE: This laboratory study is looking at biomarkers in patients undergoing transrectal~     ultrasound prostate biopsy.~   "
243053|NCT00373022|"~     RATIONALE: Physical activity may prevent or lessen depression and anxiety and improve quality~     of life and immune function in patients with colorectal cancer.~      PURPOSE: This randomized clinical trial is studying how well physical activity helps patients~     with stage II or stage III colorectal cancer recover from cancer.~   "
243054|NCT00373009|"~     We are studying whether specific back exercise and education programs effectively limit the~     development of chronic low back pain in Soldiers in the United States Army. These programs~     represent the current best evidence for prevention of low back pain from an exercise and~     education perspective. This innovative study will investigate whether a combination of~     evidence-based exercise and education programs effectively decreases the impact of chronic~     low back pain, when compared to individual evidence-based exercise and education programs, or~     a traditionally implemented exercise program.~   "
243055|NCT00372996|"~     To test the efficacy of CP-751,871 combined with exemestane in the treatment of~     postmenopausal patients with hormone positive advanced breast cancer~   "
243056|NCT00372983|"~     The purpose of this research trial is to find out whether NOV-205 is well tolerated compared~     to placebo (salt water) in people with hepatitis C. In addition, this trial will test how~     NOV-205 is absorbed by your body after single and multiple doses of the trial drug, and it~     will look for early signs of therapeutic activity (decreases in indicators in the blood for~     the hepatitis C virus and for liver damage). This is known as pharmacokinetics (PK). NOV-205~     is an experimental drug. Experimental means that the trial drug is currently being tested~     and is not approved for sale in the United States by the Food and Drug Administration (FDA).~     However, NOV-205 has been approved by the Russian Federation for treatment of liver diseases~     including hepatitis C. Clinical studies in that country showed that subjects treated with~     NOV-205 alone had decreased indicators in the blood for the hepatitis C virus and for liver~     damage.~   "
243057|NCT00372970|"~     It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a~     contributing feature. Botox relaxes the pylorus so that food can empty the stomach more~     rapidly. Lesser quality studies have shown that this treatment works in about 40% of~     patients, and relieves symptoms for up to 3 months. This study compares this treatment to~     placebo (saline) injection. After a 1 month period patients may elect to receive open label~     botox who have not received relief from their first injection. Patients symptoms and gastric~     emptying are followed for 1 year.~   "
243058|NCT00372957|"~     To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of~     GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes~     mellitus (T2DM) patients.~   "
243059|NCT00372944|"~     The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus~     capecitabine in patients with advanced or metastatic pancreatic cancer who have failed~     first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients~     in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine.~     Treatment will be continued for as long as the patients receive clinical benefit. The status~     of all patients will be checked (whether they are still taking treatment or not)~     approximately 3 months after the last patient has entered the study.~   "
243060|NCT00372931|"~     The purpose of this study is to determine whether AL-37807 is safe and effective in treating~     patients with open-angle glaucoma or ocular hypertension~   "
243061|NCT00372918|"~     The purpose of this study is to determine the prevalence of esophageal pathology in patients~     with voice disorders. In addition, , the intra- and interdisciplinary variability regarding~     the identification of esophageal pathology will be analyzed in this study.~   "
243129|NCT00372008|"~     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.~     Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this~     study will evaluate the efficacy and safety of this product.~   "
243062|NCT00372905|"~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal~     antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry~     cancer-killing substances to them without harming normal cells. Giving bortezomib together~     with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.~      This phase I/II trial is studying the side effects and best dose of bortezomib when given~     together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work~     in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.~   "
243063|NCT00372892|"~     The purpose of this study is to assess the feasibility of a randomized, double blind, placebo~     controlled trial of add-on rituximab for non-splenectomized adults with acute immune~     thrombocytopenic purpura (ITP).~   "
243064|NCT00372879|"~     Muscular cramps are a common and uncomfortable symptom of amyotrophic lateral sclerosis~     (ALS). This clinical trial will compare the response of high dose vitamin E supplementation~     to placebo for treatment of muscular cramps in patients with ALS. We hypothesize that vitamin~     E will be more effective than placebo in treating cramps.~   "
243065|NCT00372853|"~     This study will determine the highest tolerable dose of CP-675,206 when given in combination~     with SU011248.~   "
243066|NCT00372840|"~     RATIONALE: Printed educational materials, such as the Facing Forward Series: Life After~     Cancer Treatment manual, may help make the transition from cancer patient to cancer survivor~     easier in patients who are finishing treatment for cancer. It is not yet known if the Facing~     Forward Series: Life After Cancer Treatment manual and The Cancer Information Service,~     Questions and Answers fact sheet is more effective than the The Cancer Information Service,~     Questions and Answers fact sheet alone in helping to make life after cancer treatment easier~     and to improve quality of life in patients with breast cancer, colorectal cancer, prostate~     cancer, or chest cancer.~      PURPOSE: This randomized clinical trial is studying how well printed education materials work~     in assisting patients who are finishing treatment for stage I, stage II, or stage IIIA breast~     cancer, colorectal cancer, prostate cancer, or chest cancer to make the transition from~     cancer patient to cancer survivor easier.~   "
243067|NCT00372827|"~     The purpose of the study is to compare the efficacy and safety of Timolol 0.5% solution to~     Brinzolamide 1% each given twice daily when added to Travoprost 0.004% given each evening.~   "
243068|NCT00372814|"~     The study is a randomized clinical trial testing the effectiveness of Multisystemic Therapy~     (MST) for improving the treatment adherence, metabolic control and quality of life of urban~     adolescents with poorly controlled insulin dependent diabetes.~   "
243069|NCT00372801|"~     To demonstrate that new drugs work, many complex multidose studies are often required. The~     intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to~     validate a simpler single dose model for future assessment of new pain drugs.~   "
243070|NCT00372788|"~     The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus~     pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer.~     Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from~     the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as~     long as patients receive clinical benefit.~   "
243071|NCT00372775|"~     This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with~     non-small cell lung cancer with brain metastases.~   "
243072|NCT00372762|"~     Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8~     weeks of bumetanide versus furosemide therapy (equipotent dose), to test whether bumetanide~     therapy has a superior effect on insulin resistance compared to furosemide. Patients will be~     subject to a frequently sampled intravenous glucose tolerance test (FSIGT) with minimal model~     (MINMOD) analysis to assess insulin resistance and to a 6-minute walk test (6MWT) to assess~     functional capacity; patient recruitment and retention success, as well as medication~     adherence, will also be assessed.~   "
243073|NCT00372749|"~     To evaluate the effect of the threat of an aversive reaction on the response during alcohol~     cue exposure in alcohol dependent patients : (1) the subjective response (craving) and (2)~     the physiological response (heart rate and blood pressure).~   "
243074|NCT00372736|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug.~      PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given~     together with docetaxel in treating patients with locally advanced, metastatic, or recurrent~     solid tumors.~   "
243075|NCT00372723|"~     To determine whether treatment of patients who have toxic epidermal necrolysis with a drug~     called remicaide increases the number of patients who are alive 30 days laters.~   "
243076|NCT00372710|"~     Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor~     cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard~     therapies in breast cancer patients with metastatic bone lesions.~   "
243077|NCT00372697|"~     This study evaluated the safety and efficacy of an increased frequency of octreotide acetate~     injections or an increase in dose in partially responsive acromegalic patients with~     persistently uncontrolled disease.~   "
243123|NCT00372086|"~     Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need~     insulin injections, blood sugar monitoring several times each day, and adhere to a strict~     diet. Adequate control of blood glucose is essential to prevent long term kidney and eye~     complications that result in kidney failure and blindness. Adolescence is a time when~     diabetes is difficult to control, due in part to high growth hormone levels causing insulin~     resistance ( a state where the body does not respond as strongly to insulin). This study will~     test whether treatment with rosiglitazone (an oral medication used frequently in type 2~     diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1~     diabetes during puberty.~   "
244573|NCT00352742|"~     The purpose of this study is to describe the safety and effect of ATN-224 in combination with~     bortezomib (Velcade®) in patients with Multiple Myeloma who are relapsed from or refractory~     to bortezomib.~   "
243078|NCT00372684|"~     Plasmodium falciparum malaria remains a major public health problem in endemic areas, with~     approximately 2 million deaths each year, especially in tropical African countries.~      In non-endemic industrialized areas, imported malaria is generally diagnosed in travelers, as~     well as immigrants from endemic countries. Such imported cases have increased worldwide, with~     approximately 7000 cases each year in France. Among these cases, 300 are severe requiring~     hospitalization in the intensive care unit (ICU) with an overall mortality rate of 10%,~     despite available effective care.~      Many studies have been performed to evaluate clinical and physiopathological aspects of~     severe malaria in endemic areas but few data are available for imported malaria. Therefore,~     determinants of severe imported malaria are not well known. The majority of patients~     hospitalized in the ICU for severe malaria are white caucasians as well as those patients who~     die.~      The present study has two main objectives:~      (i) to describe the clinical spectrum of severe imported malaria and to assess outcome~     (mortality and neurological sequelae), and the biological interactions between host and the~     parasite,~      (ii) to evaluate the role of gene polymorphisms, of parasitic factors in the occurrence of~     severe malaria with a case control study comparing severe and non-severe malaria in patients~     matched according to ethnic patterns. The intensity of the inflammatory response will also be~     studied in the two groups of patients.~   "
243079|NCT00372671|"~     The purpose of this study is to determine whether a pre-discharge videotape introducing the~     concept and benefit of a Cardiac Rehabiliation & Secondary Prevention (CRSP) program will~     increase intent to participate in a CRSP program in post myocardial infarction, unstable~     angina, coronary artery bypass surgery, or coronary angioplasty patients.~   "
243080|NCT00372658|"~     The purpose of this study is to compare the efficacy of 1% lidocaine intracervical block to~     placebo for pain control during the performance of a hysterosalpingogram (HSG). We~     hypothesized that an intracervical block would decrease pain during a hysterosalpingogram.~   "
243081|NCT00372645|"~     The aim of this study is to determine the best source of folate to raise the folate status of~     a general population over a 16 week intervention period.~   "
243082|NCT00372632|"~     The present study will address the question whether the use of IPT using SP in pregnancy is~     efficacious in Rwanda, where it is going to be used for the first time, in areas with high~     levels of SP resistance. While the implementation of the new policy will take place in areas~     at low SP resistance level, where we expect pregnant women and newborns to benefit from it,~     it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high~     SP drug resistance and at what level of SP resistance this strategy is still efficacious. As~     bed nets are a part of the actual control strategy of malaria in pregnancy all women will~     receive a bed net at enrolment~   "
243083|NCT00372619|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when~     given together with cytarabine and to see how well they work in treating young patients with~     refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I~     closed to enrollment as of 09/16/09)~   "
243084|NCT00372606|"~     The purpose of this study is to conduct a randomized trial to rigorously test the efficacy of~     the MiDieta eHealth portal for weight loss among overweight, though otherwise healthy,~     members of the Hispanic community, many of whom may be members of collaborating managed care~     organizations.~   "
243085|NCT00372593|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as gemtuzumab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab~     may kill more cancer cells. It is not yet known whether combination chemotherapy is more~     effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid~     leukemia.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab~     to see how well they work compared with combination chemotherapy alone in treating young~     patients with newly diagnosed acute myeloid leukemia.~   "
243086|NCT00372580|"~     Psoriasis is a chronic inflammatory skin disease characterized by the formation of scaly and~     erythematous plaques. A Th1-cell mediated process is believed to be involved in the~     pathogenesis of psoriasis. It is mainly because of the detected Th1 cytokine profile in the~     sera and tissue. Epidemiologic studies also showed a significantly decreased incidence of~     atopic dermatitis. According to the Th1 and Th2 dogma, psoriasis and atopic dermatitis are~     two mutually exclusive dermatoses. However, the simple dichotomy of Th1 and Th2 in the~     pathogenesis of psoriasis and atopic dermatitis may be overly simplistic.1. Recent genetic~     studies suggest striking overlapping genetic loci for both psoriasis and atopic dermatitis.~     In fact, atopic dermatitis and psoriasis shared more genetic similarity than atopic~     dermatitis and asthma. 2. It is indeed, difficult to find patients with both typical atopic~     dermatitis and psoriasis. However, asthma is not so rarely encountered in psoriasis. And~     asthma is one of the hallmark in the diagnosis of atopic dermatitis. 3. The cytokine profile~     in long-standing atopic dermatitis shifted to a Th1 profile. A mixed Th1 and Th2 chemokine~     profiles are present in atopic dermatitis. Scratch can result in a Th1 infiltrate in animal~     model. 4. Patients with erythrodermic psoriasis has a higher percentage of elevated IgE~     levels. And tissue or peripheral eosinophilia might be present. 5. Eczema is a known~     precipitating factor of psoriasis. Areas of atopic dermatitis in childhood may serve as~     koebernizing loci for the future development of psoriasis. And in adulthood, since the main~     pathologic event of asthma is in the aerorespiratory tract, the presence of Th2 cytokine~     profile does not seemingly affect the build up of a Th1 profile in the skin of psoriasis.~   "
243087|NCT00372567|"~     A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive~     disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5~     mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side~     effects of taking sunitinib or imatinib for approximately one year.~   "
243088|NCT00372541|"~     Acute lower respiratory tract infections are a leading cause of morbidity and mortality in~     sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous~     chloramphenicol for the treatment of severe pneumonia in children aged less than five years.~     However, up to 20% of children fail treatment due to the emergence of resistance by bacteria.~     Several centers now use ceftriaxone, a third generation cephalosporin, which is reported to~     be efficacious in the treatment of severe pneumonia. However the high cost of ceftriaxone is~     too prohibitive to allow for its routine use in resource constrained countries. The purpose~     of this study is to compare chloramphenicol and ceftriaxone in the treatment of severe~     pneumonia in children under five.~      We hypothesize that 92.7% of children who receive once daily intravenous ceftriaxone (75~     mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80.2 % of those~     who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).~   "
243089|NCT00372528|"~     The main purpose of this trial is to allow continued access to pregabalin to Canadian~     subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114~     and 1008-164 and to continue to study the long term safety of pregabalin administered as~     adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with~     refractory partial seizures.~   "
243090|NCT00372515|"~     The primary purposes of this study are to find out if using high doses of the drug Gefitinib~     (Iressa) as a way to treat patients with non-small cell lung cancer that has spread to the~     covering of the brain and/or spinal cord (meninges) results in any bad side effects; and to~     determine the highest dose that can be given to patients in this setting.~   "
243091|NCT00372502|"~     The purpose of this study is to determine if there is equivalence between two different~     methods of treating patients with severe bloodstream infection called sepsis. We will~     randomly assign patients to one of two treatment methods. One of the treatment methods is the~     current standard of care and uses an infrared sensor on the end of a catheter to determine~     the adequacy of treatment. The second treatment method is identical to the first but instead~     of the infrared sensor a blood test that is performed as a part of standard care (with blood~     drawn from the catheter) will be used to determine the adequacy of treatment. This study will~     attempt to determine an easier method of guiding treatment.~   "
243092|NCT00372489|"~     The purpose of this study was to evaluate the long term safety and tolerability of~     peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease~     (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.~   "
243093|NCT00372476|"~     This study is designed to investigate the safety and efficacy of the combination of imatinib~     and vinorelbine in patients with advanced, anthracycline resistant breast cancer~   "
243094|NCT00372463|"~     Diabetes is a growing health problem causing personal suffering, comorbid conditions,~     premature death, and high costs to the individual, the health care system and society. Many~     of these problems can be prevented or delayed by controlling the disease. This in turn~     requires daily self-management by patients.~      We will evaluate an Internet based small group Diabetes Self-Management Program. This program~     will be adapted from the Chronic Disease Self-Management Program Online, already developed~     and currently being evaluated by the investigators. Participants with type 2 diabetes will be~     randomized to participate in the Internet Program or serve as controls continuing with usual~     care. Treatment subjects will participate in a structured 6 week interactive web-based online~     class with 20-24 other participants and 2 trained peer moderators.~      If successful, this project will result in a new and effective means of reaching the CDC~     objective and more importantly in improving the quality of life and health status of people~     with diabetes while reducing health care utilization and thus costs.~   "
243095|NCT00372450|"~     RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve~     quality of life in patients with malignant dysphagia caused by esophageal cancer or~     gastroesophageal junction cancer.~      PURPOSE: This randomized clinical trial is studying self-expanding plastic stents to see how~     well they work compared with self-expanding metal stents in treating patients with malignant~     dysphagia caused by esophageal cancer or gastroesophageal junction cancer.~   "
243096|NCT00372437|"~     Inthis study, MGCD0103, a new anticancer drug under investigation, is given three times~     weekly in combination with gemcitabine to patients with solid tumours.~   "
243097|NCT00372424|"~     This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity~     of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or~     metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment~     in the advanced disease setting.~   "
243098|NCT00372411|"~     This study will compare robotic training with usual care and intensive comparison therapy to~     attempt to improve upper extremity function.~   "
243099|NCT00372398|"~     The purpose of this trial is to study the proportion of scleroderma patients who suffer from~     asymptomatic coronary atherosclerosis compared to healthy controls.~   "
243100|NCT00372385|"~     Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon~     Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C~     virus (HCV) ribonucleic acid (RNA) levels~   "
243101|NCT00372372|"~     The efficacy of risedronate in prevention of bone loss in patients receiving high dose~     corticosteroid treatment~   "
243102|NCT00372359|"~     The purpose of this study is to find out whether prolonged treatment with methylphenidate has~     any adverse effect on cardiac functions and measurements.~   "
243103|NCT00372346|"~     Experimental data suggest that transplantation of endothelial progenitor cells (EPCs)~     attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition,~     clinical studies suggest that autogolous progenitor cells transplantation is feasible and~     safe in patients with ischemic disease. This study will investigate the feasibility, safety,~     and initial clinical outcome of intravenous infusion of autologous EPCs in patients with~     idiopathic pulmonary arterial hypertension.~   "
243104|NCT00372333|"~     The main aim of the study is to evaluate safety, efficacy, compliance, and usage of~     epicutaneously applied IDEA-033 in joint / musculoskeletal pain or soft tissue inflammation.~   "
243130|NCT00371995|"~     Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral~     leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will~     be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six~     months.~   "
243105|NCT00372320|"~     This study will examine whether the experimental drug AdhAQP1 can increase salivary flow in~     patients whose parotid glands have been exposed to therapeutic radiation for treatment of~     head and neck cancer. Radiation may damage the parotid glands (salivary glands located under~     the skin in front of the ear), leading to dry mouth, infections, excessive tooth decay, mouth~     sores, difficulty swallowing and pain. AdhAQP1 contains the human aquaporin-1 gene, which~     codes for a protein that works to transport water across cells, and a virus that normally can~     cause colds in humans, but is modified to render it ineffective. In animal experiments,~     AdhAQP1 has increased saliva production for a short time.~      Patients between 18 years of age or older who received radiation treatment for head and neck~     cancer at least 5 years before enrolling in this study, who have no evidence of recurrent~     tumor, who have dry mouth and who secrete abnormally low levels of saliva from the parotid~     glands may be eligible for this study. Candidates are screened with a medical history,~     physical examination, blood, urine and saliva tests, electrocardiogram (EKG), chest x-ray,~     MRI exam, gallium scan (a nuclear medicine test to look for inflammation in the salivary~     glands), technetium pertechnetate scan (a nuclear medicine test to examine salivary gland~     function), parotid sialogram (x-ray of parotid gland), PET and CT scans to look for signs of~     tumor and a skin biopsy to collect skin cells for use in immunological tests.~      Participants have a salt and sugar solution infused through a catheter (plastic tube) into~     both parotid glands. After 10 minutes, the solution drains into the mouth and is swallowed.~     Saliva is collected from the parotid glands at 6 and 24 hours after administration of the~     salt and sugar solution. Ten to 14 days later, patients are admitted to the NIH Clinical~     Center for up to 4 days for the following tests and procedures:~        -  On the first day, administration, through a catheter, of the study drug AdhAQP1 into one~          parotid gland.~        -  Monitoring over the next 3 days for changes in patients' ability to produce saliva. This~          includes medical examinations and several blood, urine and saliva collections.~        -  Technetium scan on day 2.~        -  Gallium scan on day 2.~      Patients return to NIH for follow-up visits at 1, 2, 4, and 6 weeks after the AdhAQP1~     infusion and then 3, 4, 5, 6 and 12 months for a medical examination and blood, urine and~     saliva collections. Gallium, technetium and MRI scans are repeated at several of the~     follow-up visits, and sialograms are done at 6 and 12 months. Chest x-ray and EKG are~     repeated at 4 and 6 months.~   "
243106|NCT00372307|"~     Patients with vitiligo vulgaris are treated with Pimecrolimus twice a day during 6 months.~     After a baseline visit, patient returns for a control visit after 3 and 6 months of~     treatment. One reference lesion is clinically evaluated with pictures.~   "
243107|NCT00372294|"~     Toxoplasmosis, an intra cellular parasite, is a very important cause of chorioretinitis. The~     goal of treatment is arresting multiplication of the parasite in its inflammatory active~     phase. In this study the investigators try to compare the efficacy of the classic regimen~     (Pyrimethamine-Sulfadiazine + Prednisolon) with intravitreal Clindamycin & Dexamethasone.~   "
243108|NCT00372281|"~     USPIO contrast enhancement results from intracellular trapping of the iron particles in~     reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages~     are present in spine infectious diseases but are absent in spine degenerative diseases. The~     aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The~     absence of macrophages in degenerative lesions should help to differentiate them from~     infectious lesions, who should present contrast enhancement in relation to the presence of~     macrophages.~   "
243109|NCT00372268|"~     During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia.~     Different types of gas conditioning have been studied in order to prevent this specific~     hypothermia. Intra-abdominal administration of local anesthetics has also been studied in~     order to prevent post-operative pain. In both cases, some results have been described.~      The investigators propose to evaluate in a prospective, randomized, double blind trial, the~     impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb~     surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning~     are:~        -  CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl~        -  CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal~          administration of Nacl~        -  CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2%~        -  CO2 dry and cold with direct intra-abdominal administration of Nacl~      The investigators use a new device (Aeroneb® Pro [Aerogen® Company]) which can wet (by~     nebulization) the insufflated gas and therefore permits intraperitoneal medicament~     administration (local anesthetics).~   "
243110|NCT00372255|"~     The study will evaluate the immune response and the tolerability of the influenza vaccine~     administered in children aged 6-13 years old.~   "
243111|NCT00372242|"~     The Bangladesh Integrated Nutrition Project (BINP) of the Government of Bangladesh has~     started showing reduction in malnutrition of women and children under two years of age in~     last 3 years of it’s activities. That was a demonstration study to test the efficacy of the~     approach on a relatively small number of children with intensive intervention. A study will~     be therefore conducted in 4 division of BINP thanas of Bangladesh over an 18-month period.~     Moderately malnourished children will be in management intervention and mildly malnourished~     and well-nourished infants will be in preventive intervention group. For management~     intervention, a total of 750 moderately malnourished will be randomized to receive either~     intensive nutrition education or less intensive education. For preventive purpose, 380 mildly~     malnourished children of 6 months to 2 years of age and 240 well nourished infants of 6 to 9~     months of age will receive either less intensive education or no education. Infants between 6~     to 9 month ages will be brought under less INE to ensure their complementary feeding~     practice. Care givers of one group of mildly malnourished children and one group of 6-9 month~     old infants will not receive any education to serve as controls. Focus group discussion will~     be held before the educational intervention to identify the perception of the mother, her~     husband and female decision maker of her family on child nutrition, caring practice and~     common practice of health care. BCC materials will be developed after FGD and that will be~     used during nutrition education. Mothers of the first intervention group will receive~     intensive nutrition education for child feeding twice weekly for first three months, which~     will be then reinforced once in a week for the last three months of intervention. The less~     intensive intervention group will receive nutrition education twice a week for the first~     month then once a week for two months and then twice monthly for the last three months of~     intervention. INE will be given for a total of 6 months. An observation will be done to~     identify for sustainability effect for an additional period of 6 months. Their weight and~     length gain will be recorded. It is expected that the results of the study will help define~     the effectiveness of our nutrition education package to prevent and reduce moderate~     malnutrition existing in large proportion of children in setting with different geographical,~     and cultural and feeding practices.~   "
243112|NCT00372229|"~     This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily)~     prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active~     CMV infection, in CMV positive renal transplant recipients. The influence of the two~     prevention concepts on the occurrence of direct and indirect effects of active CMV infections~     will be compared. The anticipated time on study treatment is 3 months-1 year, and the target~     sample size is 100-500 individuals.~   "
243124|NCT00372073|"~     This is a randomized Phase II study of an experimental anti-cancer drug called seliciclib.~     The main objective of this study is to learn if, and how long, seliciclib can keep the~     non-small cell lung cancer in check.~      An experimental drug is a drug which has not been approved by the U.S. Food and Drug~     Administration (FDA) or other regulatory agencies for marketing and is still under study to~     determine how safe it is, what its side-effects are, and whether or not it is effective in~     the treatment of non-small cell lung cancer.~   "
243125|NCT00372060|"~     The clinical study determines the safety and efficacy of MK0431 in patients with type 2~     diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.~   "
243126|NCT00372047|"~     In this study, test persons with chronic excessive UV radiation and a control group are~     examined by multiphoton laser imaging and biophysical methods in order to evaluate the dermal~     fiber network. We expect to observe signs of advanced skin aging in the test group.~   "
243113|NCT00372216|"~     Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary~     arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted~     myocardium, which can be achieved by either thrombolytic therapy or primary PCI.~      Primary PCI is facilitated if the flow in the target vessel is restored prior to the~     intervention. In addition the results of recent trials hint that clinical outcome is improved~     by a patent infarct-vessel before primary PCI. The CIPAMI-study analyses the effect of an~     early administration of Clopidogrel on the flow-rates in subjects who suffered an acute~     myocardial infarction. For this purpose they are divided into two groups, both receiving~     standard baseline treatment. The subjects of one group additionally receive 600mg of~     Clopidogrel, as early as possible, while the subjects in the second group receive standard~     therapy. In the second group Clopidogrel is not allowed before initial angiography.~      In both groups the flow-rates before and after PCI are analysed and compared in order to~     evaluate the efficacy, feasibility, and safety of the administration of a high loading dose~     Clopidogrel in the very early phase of STEMI in the prehospital setting.~   "
243114|NCT00372203|"~     Proper staging of Lung cancer is of paramount concern when determining a treatment regime.~     Currently the assessment of surgical candidacy is performed with the staging process, mainly~     the mediastinoscopy. A mediastinoscopy has the ability to access samples of the paratracheal~     lymph node stations (Levels 2R, 2L, 3, 4R, 4L), as well as the anterior subcarinal lymph node~     station (Level 7). In comparison, the EBUS-TBNA technique is a real-time procedure that has~     the potential to access the same paratracheal and subcarinal lymph node stations associated~     with the mediastinoscopy, but also extending out to the hilar lymph nodes (Levels 10 and 11).~     Because of the possibility of extended sampling range and a reduction in procedural~     invasiveness, EBUS-TBNA may represent a more efficient patient centered alternative to~     mediastinoscopy in the staging of lung cancer patients. Additionally, patients who are have~     lymph nodes in the N2 region frequently undergo chemotherapy and/or radiotherapy prior to~     surgery. Assessment of the lymph nodes after chemo/radiation is done using CT scans, as~     re-mediastinoscopy is a technically difficult procedure. These patients may benefit from~     EBUS-TBNA.~   "
243115|NCT00372190|"~     Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The~     recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a~     mesh aims at reducing the recurrence rate, but mesh implants can cause complications.~      This study is designed to determine the effectiveness of one type of mesh (tensionfree~     vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is~     to track the complications of both procedures.~   "
243116|NCT00372177|"~     Rheumatoid arthritis (RA) is a disease with a large economic impact due to the long lasting~     disabling nature of the disease. Furthermore, diagnosis of the disease is difficult and only~     a scheme with different symptoms is used to diagnose rheumatoid arthritis, often only by~     probability.~      Due to the fact that effective disease modifying pharmacological treatment is available and~     should be started early in established cases of RA, in combination with the adverse effect~     potential of these substances (e.g. methotrexate), a fast reliable diagnostic tool to~     diagnose rheumatoid arthritis would be highly appreciated by the medical community and the~     patients. Furthermore, for invasive treatments (surgery, puncture), an imaging method to~     display the activity pattern in different joints would be a major advantage.~      For the evaluation of the effectiveness of pharmacological therapy in rheumatoid arthritis,~     up to now, radiological measurements of the destruction process of the joints are used. This~     method has the disadvantage that it is time consuming insofar as changes in the radiological~     images must occur. It allows only an evaluation if the joints are destructed (which should be~     excluded by the new therapy regimen). Again, a quantifiable method for the determination of~     the effects of new therapeutic approaches would be highly appreciated.~   "
243117|NCT00372164|"~     To demonstrate clinically significant improvements in the patients treated following ASIPP~     guidelines compared to the patients who were treated prior to the establishment of ASIPP~     guidelines.~   "
243118|NCT00372151|"~     The aim of the proposed study is to investigate the efficacy and safety of add-on~     gamma-glutamylethylamide (L-theanine) versus a placebo for antipsychotic treatment for 8~     weeks in a randomized, double-blind, parallel group study of 60 patients with schizophrenia~     and schizoaffective disorders.~   "
243119|NCT00372138|"~     The main risk of aortic aneurysms is rupture that leads to a high risk of death. A preventive~     surgical treatment is thus needed. In order to reduce the morbidity and mortality associated~     with conventional surgery, an endovascular approach (insertion of an endovascular stent~     graft)is now widely favored. The main problem of this procedure is the occurrence of~     endoleaks (persistence of a communication between the aneurysm and the aorta). A new approach~     is proposed to prevent these endoleaks. The principle is to draw blood from the patient,~     separate the blood from the platelets, and reinject both platelet rich plasma (PRP) and~     autologous thrombin, in order to form a platelet gel (PRP + autologous thrombin). Before~     studying the efficacy of this technique, its safety of use and feasibility must be evaluated.~   "
243120|NCT00372125|"~     The aim of this study is to study the effects of GH on body composition, lipid and glucose~     metabolism, physical performance and safety aspects in adults with PWS.The patients are~     randomized to either GH or placebo the first year of the study, subsequently followed by two~     years of GH treatment. the study is performed in Norway, Sweden and Denmark.~   "
243121|NCT00372112|"~     The compound GW642444 has previously been found to be well tolerated with no significant side~     effects in subjects with asthma and healthy volunteers. This study will assess the safety and~     tolerability of GW642444 in subjects with COPD in order to obtain information to support~     dosing in a broader population of subjects with COPD~   "
243122|NCT00372099|"~     Calcitonin has been used for many years for treating osteoporosis in postmenopausal women.~     Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of~     microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent~     vertebral fractures at baseline.This pilot study should provide additional new insights in~     the mode of action of nasal calcitonin, on structural changes as measured by high resolution~     peripheral CT, and on the comparison between weight bearing and non weight bearing bones in~     postmenopausal women.~   "
243127|NCT00372034|"~     The purpose of this study is to evaluate the role of tear volume in discomfort and dryness~     sensations during contact lens wear, and the possible influence on osmolality and ocular~     surface sensitivity.~   "
243131|NCT00371982|"~     1. whether the intake of n-3 PUFA has additional effects on insulin sensitivity and~          adiposity (total fat mass and adipocyte morphology and function) in T2D women.~        2. n-3 PUFA supplementation might influence inflammatory genes expression in the adipose~          tissue of T2D patients.~   "
243132|NCT00371969|"~     The main aim of this study is to test an intervention to reduce unsafe drinking among~     HIV-positive primary care patients. The intervention consists of a brief motivational~     interview, which is combined with daily alcohol monitoring through the use of an interactive~     voice response system IVR (automated telephone system). Subjects who receive the enhanced~     motivational interview are expected to show greater improvements in drinking than individuals~     who receive the standard motivational interview or view a DVD on HIV self-care.~   "
243133|NCT00371956|"~     This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene~     in the prevention of bone mineral density loss in patients receiving long term~     corticosteroids.~   "
243134|NCT00371943|"~     Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal~     ligation have been proven plausible in the prevention of variceal rebleeding. However, the~     relative efficacy and safety of the combined treatment for preventing rebleeding remains~     unresolved.~   "
243135|NCT00371930|"~     24 test persons are treated with a dye suspension followed by a laser intervention. A~     decrease of hair density is expected.~   "
243136|NCT00371904|"~     About one third of prospective kidney transplant recipients have antibodies in their blood~     directed against the tissues of their only available kidney donor. Recently,~     desensitisation treatments when administered pre-transplant have allowed successful~     transplantation of these patients despite high rates of acute antibody mediated rejection~     (AAMR). The investigators propose to test in a randomised controlled trial whether rituximab,~     a monoclonal antibody that depletes B-lymphocytes, will safely lower antibody mediated~     rejection (AMR) rates when added to standard therapy. The investigators will also test~     whether rituximab enables more patients to achieve a negative crossmatch against their donor~     and thereby allow more transplants to proceed.~   "
243137|NCT00371891|"~     Multidetector Computed Tomographic Coronary Angiography (MDCTCA) has been recently~     demonstrated to be accurate and may be used as a potential alternative to conventional~     invasive coronary angiography, which requires cardiac catheterization, for the diagnosis of~     coronary artery disease. The purpose of this study is to see if MDCTCA can identify~     significant coronary artery disease as good as or better than conventional coronary~     angiography (CICA). The study is designed to enroll 900 subjects and is being conducted in 6~     hospitals in Ontario. Subjects scheduled for conventional cardiac catheterization and~     coronary angiography will receive an additional test using MDCTCA. The information gathered~     during the MDCTCA will be compared to the results of the scheduled conventional invasive~     coronary angiogram.~   "
243138|NCT00371878|"~     Lung immune responses are regulated independently of systemic responses. Injected vaccines~     may induce optimal responses in blood but not at mucosal surfaces. We compared the responses~     in serum and lung fluid to injected pneumococcal conjugate vaccine.~   "
243139|NCT00371865|"~     The purpose of the study is to test a brief, group-administered psychosocial intervention to~     reduce interference of pain with daily life, emotional distress, and pain intensity, and~     improve quality of life and physical activity levels in individuals with chronic pain.~   "
243140|NCT00371852|"~     The purpose of this study is to demonstrate the absence of irritation potential (primary~     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the~     product Dermacyd wipes.~   "
243141|NCT00371839|"~     The purpose of this study is to determine the effects of age-related cognitive changes on~     hearing aid benefit based on hearing aid compression time constants.~      The hypothesis is that people with poor working memory skills will benefit from slow time~     constants in hearing aid compression while those with good working memory skills will be able~     to benefit from more sophisticated compression algorithms with rapid time constants.~   "
243142|NCT00371826|"~     The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation~     versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure~     cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium~     (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will~     be compared to a third control group, who will receive treatment consisting of cyclosporine~     micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.~   "
243143|NCT00371813|"~     To investigate safety and efficacy of varenicline tartrate in helping people quit smoking~   "
243144|NCT00371800|"~     the purpose of this study is to determine if cinnamon improves glucose control among~     adolescents with type 1 diabetes mellitus.~   "
243145|NCT00371787|"~     To evaluate the performance of the study soft lens for vision, comfort, physiology and lens~     surface properties.~   "
243146|NCT00371774|"~     Purpose:~      To develop a real time national clinical database to support and share best practices,~        1. To generate hypotheses for future clinical research~        2. To understand how AMEVIVE is used in routine clinical practice/real world setting.~      Each patient visit will include the following observational endpoints:~        1. AMEVIVE dosing~        2. Number of courses~        3. Concomitant treatment~        4. Response to treatment (patient and physician global assessments)~        5. Status of other psoriasis-related medical conditions~        6. Time to re-treatment.~   "
243147|NCT00371761|"~     This is an open label, randomized, comparative, multi-center study. Subjects will be screened~     within 2 weeks prior to study entry to establish eligibility. Subjects who meet all the~     selection criteria will be randomly assigned 1:1 to (1) once-a-week, subcutaneous Pegylated~     interferon alfa-2b (PegIntron) (1.5 mcg/kg body weight) or (2) oral adefovir 10 mg daily. The~     treatment phase will be 24 weeks for PegIntron and 48 weeks for adefovir. All subjects~     completing the assigned treatment phase will be followed up for an additional 48 weeks for~     PegIntron and 24 weeks for adefovir as observation phase. The primary objective is to~     establish the efficacy profile of PegIntron. Secondary objectives are to compare the efficacy~     profile of PegIntron with that of adefovir, compare efficacy of PegIntron in lamivudine-naïve~     and lamivudine-experienced subjects, and to establish the safety profile of PegIntron in~     treating patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.~   "
243148|NCT00371748|"~     TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients with~     coronary arteries less than 2.5 mm in diameter who are treated with the TAXUS Liberté stent~     versus an historical TAXUS Express control derived from a subset of lesion-matched TAXUS V~     patients treated with a 2.25 mm stent. The objective of the study is to evaluate clinical and~     angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions. The hypothesis is~     that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR~     stent in the treatment of de novo lesions in small coronary vessels.~   "
243149|NCT00371735|"~     CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a~     public-private partnership with the Medicines for Malaria Venture (MMV), World Health~     Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical~     Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a~     treatment for acute uncomplicated P. falciparum malaria.~      The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has~     already been shown to be efficacious against P.falciparum in adults and children in~     Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the~     parasite kill rate as demonstrated in the phase II study, and reduce the chance of any~     parasites escaping treatment over the 3-day course. The addition of artesunate is also~     anticipated to have the population benefit of protection against the development of resistant~     strains of P.falciparum, although it will not be possible to demonstrate this in a clinical~     trial. One further population benefit of the artemisinin drugs are their ability to suppress~     the sexual forms of the parasite (gametocytes), which should reduce infectivity after~     antimalarial treatment and potentially lower transmission rates with widespread use,~     including the spread of any parasites resistant to the partner drug.~      The aims of this phase III study are to compare the efficacy of a fixed ratio combination~     tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a~     multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and~     adults, with chlorproguanil-dapsone as a comparator.~   "
243150|NCT00371722|"~     Women having cesarean section will be divided into two groups - cesarean section alone or~     cesarean section with appendectomy. The purpose is to see if the appendectomy can be done~     without adding any complications to the maternal post-operative course. The hypothesis is~     that there is no increased incidence of wound infection, post-operative morbidity or longer~     hospital stay associated with elective appendectomy at the time of Cesarean Section.~   "
243151|NCT00371709|"~     TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results~     from patients treated with the TAXUS Liberté stent to an historical TAXUS Express control.~     The control group is a case-matched, blended population of TAXUS Express patients from the~     TAXUS IV and TAXUS V de novo clinical trials. The objective of the study is to evaluate~     clinical outcomes of TAXUS Liberté-SR stent in de novo lesions and to assess the~     non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR stent is~     hypothesized to have comparable safety and efficacy to the TAXUS Express stent.~   "
243152|NCT00371696|"~     The aim of this study was to provide essential pilot data on the feasibility of conducting~     n-of-1 trials within secondary care within the UK, notably to: test the process of~     recruitment and design aspects of such trials; assess the acceptability of this research~     method to patients, explore the experiences of patients involved; determine the most~     appropriate treatment for individual patients.~   "
243153|NCT00371683|"~     The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep~     vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee~     replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for~     preventing these clots. The safety of apixaban will also be studied.~   "
243154|NCT00371670|"~     This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage~     loss in patients with painful knee osteoarthritis which is confirmed by X-ray~   "
243155|NCT00371657|"~     The purpose of this retrospective pilot study is to address the effect that obesity, in the~     absence of other comorbidities, has on birth weight. We wish to determine if obesity is a~     risk factor for small for gestational age (SGA) or intrauterine growth restricted (IUGR)~     infants in our clinic population. There have been many studies linking maternal obesity with~     fetal macrosomia, defined as fetal birth weight greater than 4500 grams. However, we have~     noted that a percentage of our obese patient population has delivered either an SGA or IUGR~     infant. SGA refers to a constitutionally small infant weighing less than the 10th percentile~     for age. This refers to a genetically normal infant. IUGR refers to a fetus whose growth has~     been restricted by influences other than normal genetics.~      Our study population will consist of all women over the age 18 who delivered a term infant~     either by vaginal delivery or cesarean section at Tulsa Regional Medical Center between July~     1st 2004 and December 31st 2005.~      The diagnosis of obesity will be based upon a Body Mass Index (weight in kilograms/height in~     meters squared) of thirty or greater. We will look at the infant birth weight as recorded in~     the patient's chart. We will define SGA or IUGR as birth weight less than the 10th percentile~     for gestational age as defined previously. The control group will consist of women meeting~     the same criteria except they will have a BMI less than thirty but greater than 19.8 as low~     maternal weight is also a risk factor for IUGR. We will compare the average birth weight and~     the rates of SGA/IUGR infants between the two groups and analyze using the chi-squared method~     of analysis.~   "
243156|NCT00371644|"~     The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy~     (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress~     symptoms associated with sexual assault that occurred while veterans were serving in the~     military.~   "
243157|NCT00371631|"~     The purpose of the research is to determine whether we can get harmless bacteria to live in~     the bladders of persons with spinal cord injury who practice intermittent bladder~     catheterization. We will also look at whether having the harmless bacteria in the bladder~     prevents urinary tract infections from occurring.~   "
243158|NCT00371618|"~     To determine clinically significant improvement in the patients undergoing procedures under~     fluoroscopy.~      To evaluate and compare the adverse event profile in both groups~   "
243201|NCT00371033|"~     The purpose of this study is to determine whether pregabalin is an effective treatment for~     Chronic Prostatitis/Chronic Pelvic Pain Syndrome.~   "
243159|NCT00371605|"~     A fixed-dosing regimen of voriconazole is routinely used as prophylaxis against aspergillosis~     in liver transplant patients admitted to the transplant intensive care unit at UPMC. We~     hypothesize that use of a fixed-dosing regimen of voriconazole will lead to a large degree of~     variability in drug exposure among liver transplant patients due to: 1) variability in~     absorption and elimination caused by physiological characteristics unique to this patient~     population 2) its non-linear pharmacokinetics and 3) the potential for polymorphism in the~     genes that encode for cytochrome P-450 enzymes that metabolize voriconazole. This is a pilot~     clinical pharmacokinetic evaluation that will: 1) characterize the plasma concentration~     versus time profile of voriconazole in liver transplant patients receiving a fixed-dosing~     regimen to assess for extremes in systemic exposure 2) determine the oral bioavailability of~     voriconazole in liver transplant patients 3) assess for functionally significant allelic~     variation of the cytochrome P-450 enzymes that metabolize voriconazole (CYP2C9, CYP2C19 and~     CYP3A4/5) in both recipient blood and allograft tissue that may contribute extremes in~     systemic exposure among liver transplant patients. This evaluation will allow for an~     assessment of the adequacy of the prophylactic regimen in achieving therapeutic drug~     concentrations in all subjects. Additionally, the utility of genotyping as a clinical tool to~     identify patients at risk for extremes in voriconazole exposure will be evaluated. The~     characterization of the pharmacokinetics in liver transplant patients may be utilized to~     define an optimal therapeutic regimen that will be individualized to target specific~     concentrations to maximize efficacy and minimize side-effects.~   "
243160|NCT00371592|"~     The purpose of this study is to determine whether acyclovir is effective in suppressing HIV~     viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are~     starting HIV treatment for the first time.~   "
243161|NCT00371579|"~     Objective: Determine if maximum doses of rosuvastatin are safe in patients infected with~     hepatitis C and if the so called pleiotropic effects of rosuvastatin cause a decrease in the~     HCV viral load.~      Primary study parameters: 1. to which extend causes rosuvastatin serious side effects like~     rhabdomyolysis and hepatotoxicity in patients chronically infected with hepatitis C? 2. does~     treatment with rosuvastatin in HCV infected patients lead to lower HCV-RNA viral load? 3. Is~     a decrease in LDL correlated to a decrease in HCV-RNA load?~   "
243162|NCT00371566|"~     This is a study comparing the activity of lapatinib versus placebo followed by~     chemoradiation. This study is designed to explore the effects of lapatinib monotherapy on~     apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects~     with locally advanced squamous cell carcinoma of head and neck.~   "
243163|NCT00371553|"~     The purpose of this study is to investigate the activity of SU011248 in subjects with~     cisplatin-refractory or multiply relapsed germ cell cancer. It is believed that SU011248~     treatment may prove to increase disease response.~   "
243164|NCT00371540|"~     The objective of this application is to develop and assess a system which uses non-clinician~     extenders to provide selected aspects of HIV care in rural western Kenya. The plan is to~     train persons living with HIV/AIDS (PLWAs) to undertake this role as Community Care~     Coordinators. Our central hypothesis, is that PLWAs can be effective members of the health~     care team and that their involvement in community-based HIV care will facilitate patient~     access to services and improve outcomes. As such our two specific aims are: 1) To develop a~     sustainable system to extend HIV care into the community and to train the individuals~     necessary to support such a system (Community Care Coordinators). 2) To determine the impact~     of Community Care Coordinators on patient adherence (to drugs and to clinic visits), clinical~     outcomes (i.e. viral load responses [an individuals level of circulating HIV virus],~     inter-current opportunistic infections, hospitalization, drop out from the program, change to~     second line therapy and mortality) and patient perception of stigma. This study will provide~     invaluable data on the use of non-clinician care extenders for providing HIV care in resource~     poor settings. As such, knowledge gained from this study will assist in developing a model~     for non-clinician centered HIV care systems elsewhere in sub-Saharan Africa.~   "
243165|NCT00371527|"~     ABSTRACT CONTEXT: Inappropriate antibiotic prescriptions for acute bronchitis is a major~     public health concern because of antibiotic resistance. Effective therapies for managing the~     symptoms of acute bronchitis are lacking, however.~      OBJECTIVE: Determine if patients with acute bronchitis have better symptom control when~     treated with inhaled ipratropium.~      DESIGN, SETTING, PARTICIPANTS: COUGH STOP was a randomized, double blind, placebo controlled~     trial comparing ipratropium with placebo in acute bronchitis. Subjects were referred by their~     primary care provider or from urgent care clinics at a single institution. Subjects had been~     diagnosed with acute bronchitis and had no significant co-morbidities.~      INTERVENTION: Subjects received ipratropium or placebo inhalers, administering 2 puffs four~     times daily. A structured telephone interview took place 2, 4, and 8 days after enrollment.~     Medical records were reviewed at 60 days.~      OUTCOME: The primary endpoint was improvement in cough symptomology; secondary endpoints~     included subsequent antibiotic prescriptions and well being.~   "
243166|NCT00371501|"~     The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can~     reduce the progression of subclinical atherosclerosis in patients with systemic lupus~     erythematosus (SLE).~   "
243167|NCT00371488|"~     This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best)~     doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the~     tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and~     trastuzumab.~   "
243168|NCT00371475|"~     TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results~     from patients treated with the TAXUS Liberté 38 mm stent to an historical TAXUS Express~     control. The control group is a case-matched, blended, long lesion subset population of TAXUS~     Express patients from the TAXUS IV and TAXUS V de novo clinical trials. The objective of the~     study is to evaluate clinical outcomes of TAXUS Liberté-SR 38 mm stent in de novo lesions and~     to assess the non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR~     stent is hypothesized to have comparable safety and efficacy to the TAXUS Express stent.~   "
243202|NCT00371020|"~     To evaluate the effect of combined 5-FU and low molecular weight heparin in infusion on the~     rate of retinal redetachment after silicone oil removal in cases of proliferative~     vitreoretinopathy (PVR).~   "
243169|NCT00371462|"~     The purpose of this study is to determine whether including a PDA decision support tool plus~     distance support enhances the outcomes attainable by the MOVE2! (Managing Obesity for~     Veterans Everywhere) standard care alone. Primary hypotheses are that obese patients with~     chronic pain who are randomized to MOVE2! + PDA + Support will a) lose more weight by 6~     months, b) show greater maintenance of weight loss at 12 months, and c) display greater~     reduction in pain intensity and pain-related disability than those randomized to Standard~     Care. Secondary hypotheses are that MOVE2! + PDA + Support, compared to Standard Care will~     result in: a) improved quality of life, b) greater treatment adherence, and c) reduced care~     utilization.~   "
243170|NCT00371449|"~     The primary complaint of individuals with hearing loss is difficulty understanding speech in~     the presence of background noise. Although hearing aids help individuals understand speech in~     background noise better, there is a high rate of hearing aid rejection in part due to~     continued difficulty understanding speech in complex listening situations. The results of~     this study may demonstrate that speech-in-noise test results can be a predictor of hearing~     aid success. The results of this study also may lead to further studies that can evaluate~     interventions to improve hearing aid success for individuals who are identified as~     unsuccessful hearing aid users.~   "
243171|NCT00371436|"~     The purpose of this multi-site randomized clinical study is to test a model treatment program~     in a VA Audiology clinic, to evaluate its efficacy, ease of implementation, and acceptability~     to audiologists.~   "
243172|NCT00371423|"~     TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial~     comparing results from patients in whom the TAXUS Liberté stent was directly implanted~     (direct stenting) versus results from patients in whom implantation with the TAXUS Liberté~     stent was preceded by balloon angioplasty (pre-dilatation). The Control group consists of~     patients in the main TAXUS ATLAS trial, in which pre-dilatation was mandatory. The primary~     objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation. The~     primary hypothesis is that late outcomes with direct stenting of the TAXUS™ Liberté~     Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation~     with balloon catheter pre-dilatation~   "
243173|NCT00371410|"~     Macular edema constitutes the primary cause of visual impairment in diabetic patients with a~     disease duration of 20 years or more. Intravitreal triamcinolone (IVTA) and macular focal~     laser photocoagulation were reported to generate favorable results in the treatment of~     diabetic macular edema, but there have been patients with diffuse diabetic macular edema~     refractory to such treatment modalities. The present study will test the safety and the~     efficacy of the combined treatment of vitrectomy, IVTA and macular focal laser~     photocoagulation in the treatment of intractable diffuse diabetic macular edema.~   "
243174|NCT00371397|"~     This study is designed to examine the impact of hatha yoga on immune and hormonal functioning~     in healthy individuals.~   "
243175|NCT00371384|"~     This study will evaluate the effectiveness of two types of massage therapy for treating~     chronic low back pain.~   "
243176|NCT00371371|"~     The purposes of this study are to determine whether intra-arterial injection of autologous~     stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem~     cell dysfunction in patients with CLI, and to relate the stem cell function with clinical~     outcome.~   "
243177|NCT00371345|"~     This study will determine whether the investigational drug dasatinib is effective in~     treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer~   "
243178|NCT00371332|"~     The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with~     moderate to advanced periodontal disease~   "
243179|NCT00371319|"~     The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil~     for the initial therapy of active lupus glomerulonephritis.~   "
243180|NCT00371306|"~     Pregnant women with gestational or Type 2 diabetes who require medication are placed in one~     of two groups: Insulin injections or Glucovance (oral administration). Blood glucose is~     checked 5 times per day, and medication adjusted by perinatologist according to glucose~     levels. The hypothesis is that patients will have similar or improved blood glucose control~     on an oral agent as compared to control on insulin.~   "
243181|NCT00371293|"~     Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person's breathing is~     restricted during sleep. Obese individuals with OSA are at an increased risk of inflammation~     and heart conditions, but it is unknown whether this risk is related to the effects of OSA or~     obesity. This study will evaluate whether OSA or obesity plays the primary role in~     inflammation related to heart disease. The study will also determine the independent effects~     of OSA and obesity on insulin resistance and blood vessel function.~   "
243182|NCT00371280|"~     Pegging the hydroxyapatite for increasing prosthetic motility sometimes leads to some~     complications for the patient. These complications ranging from discharge, granuloma~     formation, exposure, implant infection to socket discomfort and etc. We are going to compare~     prosthetic motility, objectively and subjectively (patients satisfaction) before and after~     pegging the hydroxy- apatite, and evaluate the complications after pegging.~   "
243183|NCT00371267|"~     The purpose of this study is to determine whether telephone-delivered cognitive behavior~     therapy is effective in the treatment of chronic pain. To examine the effectiveness of this~     approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of~     age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA~     Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs)~     in Santa Rosa, San Bruno, Ukiah, and Eureka.~   "
243184|NCT00371254|"~     This study will determine whether the investigational drug dasatinib is effective in~     treatment of women with progressive advanced triple-negative breast cancer.~   "
243185|NCT00371241|"~     Infants are placed on ECMO for correction of reversible respiratory failure. Often, because a~     few of the reasons for respiratory failure show us similar things in the baby, it is~     difficult to determine exactly which is causing the biggest problem. We are now capable of~     measuring certain cells and proteins in these infants that may help us more accurately~     diagnose the exact problem. We hypothesize that infants placed on ECMO will show unique~     antibody-secreting cells responses and patterns of cytokine and chemokine (protein) response~     to illness and to the ECMO circuit. If we find unique patterns to these cells or proteins,~     they may be able to predict outcomes or guide treatment of these infants.~   "
243186|NCT00371228|"~     The purpose of this study is to determine whether the timing of the clamping of the umbilical~     cord after delivery has an impact on neonatal hemoglobin and hematocrit, tests that determine~     the number of red cells in the blood and their ability to carry oxygen. The study hypothesis~     is that delaying cord clamping until cord pulsation has ceased will increase the neonatal~     blood volume and thereby increase the hemoglobin and hematocrit.~      We propose to recruit 150 women who present for vaginal delivery at Tulsa Regional Medical~     Center. Half of the women will be randomly assigned to the immediate clamping group, which~     will entail clamping of the umbilical cord within six seconds of delivery of the fetal~     shoulders. The other half of the volunteers will be assigned to the delayed clamping group,~     which will entail clamping the cord after a palpable pulse has ceased, or after 10 minutes.~     The infants of mothers in both groups will have blood drawn for a hemoglobin and hematocrit~     at the time of the routine PKU heel stick, usually is performed within 18-24 hours of~     delivery.~      Statistical differences between the blood counts of infants in the control and study groups~     will be compared using independent samples t tests.~   "
243187|NCT00371215|"~     The purpose of this study is to evaluate whether rThrombin is safe when used for controlling~     bleeding during skin graft surgery.~   "
243188|NCT00371202|"~     it is a randomized clinical trial to compare deep lamellar keratoplasty (DLK) Using big~     bubble technique and Penetrating Keratoplasty (PK) in patients with keratoconus~   "
243189|NCT00371189|"~     Malaria is caused by a parasite carried by a mosquito. Currently, there is no vaccine~     licensed to prevent malaria. The purpose of this study is to find the most effective and~     safest dose of an experimental vaccine for the treatment of malaria. Participants will~     include 72 healthy adults, ages18 to 45, enrolled at Vanderbilt University Medical Center and~     Stanford University. Volunteers will receive 3 doses of either the malaria vaccine or placebo~     (contains no vaccine) by injection into a muscle at 0, 1 and 6 months. Investigators will~     evaluate how the body responds to increasing dosage strengths of the vaccine. Study~     procedures include physical exam, multiple blood draws, and completion of a memory aid~     (diary). Each participant will be actively involved in the study for about 12 months. Then,~     an annual phone call will be made to check for any serious illness events for a period of 5~     years.~   "
243190|NCT00371176|"~     The primary aim of this project is to examine whether administration of D-Cycloserine (DCS),~     a partial N-methyl-D-aspartate (NMDA) receptor agonist that has been shown to facilitate fear~     extinction, enhances the therapeutic benefit of exposure-based cognitive behavioral therapy~     (CBT) in OEF/OIF veterans with PTSD.~   "
243191|NCT00371163|"~     Spongiotic dermatitis is the histopathologic diagnosis commonly issued by dermatopathologists~     that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous~     dermatitis.~      The information obtained will assist in development of diagnostic methods for differentiation~     of the types of spongiotic dermatitis. This study also has the potential to lead to the~     dissection of pathologic pathways involved in these diseases and development of novel~     therapeutic agents.~   "
243192|NCT00371150|"~     The purpose of this clinical research study is to develop observational clinical experience~     with the use of entecavir in participants who are either of Black/African-American race or of~     Hispanic ethnicity.~   "
243193|NCT00371137|"~     The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to~     placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled,~     parallel group trial.~   "
243194|NCT00371124|"~     The purpose of this study is to find an optimal dose of atropine for preventing the rapid~     progression of myopia in children by comparing the efficacy, safety and functional impact of~     binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for~     the routine management of childhood myopia.~   "
243195|NCT00371111|"~     Cystoid macular edema (CME) is one of the common causes of vision loss in patients with~     UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision.~     Also there are some documents which recommend Bevacizumab(avastin) could reduce macular~     edema. This study compare intravitreous injection of triamcinolone and avastin in patients~     with resistant uveitic cystoid macular edema.~   "
243196|NCT00371098|"~     Background: Influenza vaccination is recommended in patients (pts) with cardiovascular~     disease, however there is a shortage of clinical studies proving its protective effect on~     clinical course of coronary artery disease (CAD). The aim of the study was to evaluate the~     effect of influenza vaccination on the incidence of coronary events in pts with CAD confirmed~     by coronary angiography.~   "
243197|NCT00371085|"~     Heart failure is a very common condition and is one of the main reasons people are admitted~     to hospital. There are many things people with heart failure can do to manage their condition~     at home. Unfortunately many people do not have enough information to do this and need to come~     back to the hospital because their heart failure got worse. This study will look at different~     ways to help people learn more about heart failure and how to manage their condition at home.~   "
243198|NCT00371072|"~     In this randomized clinical trial we compare trabeculectomy with mitomycin-C (T+MMC) and~     Ahmed glaucoma implant (AGI) in treatment of aphakic glaucoma in children under 16 years of~     age.Complete and qualified success were defined as 5≤IOP≤21mmHg without and with medication~     respectively and we came to this point that; T+MMC and AGI are comparable in terms of success~     rate and complications in pediatric aphakic glaucoma.~   "
243199|NCT00371059|"~     We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the~     acute situation i.e under 12 weeks~   "
243200|NCT00371046|"~     The objective of this study is to investigate the effect of the use of both sonographic~     cervical length (CL) and fetal fibronectin (FFN) on the length of outpatient triage and~     preterm labor interventions in symptomatic women with intact membranes.~      We performed a randomized trial of the use of transvaginal ultrasound cervical length and~     fetal fibronectin in women being evaluated for suspected PTL at a gestational age between 24~     and 33 weeks 6 days. Women are randomized to either a standard (blinded) or a protocol arm.~     Women in the standard arm are evaluated without the results of the CL and FFN while women in~     the protocol arm are evaluated using the results of the CL and FFN and managing physicians~     are asked to follow a specific PTL algorithm to determine a women’s eligibility for~     treatment. The primary outcome is length of stay in the triage area before discharge.~   "
243204|NCT00370994|"~     Clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic~     neurolysis compared to those patients randomized to the control group who did not receive~     adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to~     the clinical outcome measures of pain and function.~      Improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to~     control group.~      Compare adverse event profile in both groups~   "
243205|NCT00370981|"~     The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.~   "
243206|NCT00370968|"~     Three-hundred-and-fifty-two males aged 1-36 months with acute non-dysenteric diarrhoea and no~     systemic illness will be enrolled in this clinical trial. Eligible children will be~     stratified by their age (1up to 5 months, 6-35 months). Within the two age strata the~     patients will be randomized to receive zinc-ORS (fortified with 40 mg elemental zinc as zinc~     gluconate per litre) or standard WHO ORS. The major outcome measures will be stool output and~     duration of diarrhea. The safety of administering zinc will be determined by examining the~     effect of zinc ingestion on vomiting, sodium and potassium homeostasis, plasma zinc and~     copper, and iron stores and concentration of serum transferrin receptor.~   "
243207|NCT00370955|"~     The purpose of this study is to compare two surgical techniques (high vacuum and low vacuum)~     on corneal endothelium after phacoemulsification.~   "
243208|NCT00370942|"~     This study was designed to find dose response and as extension in treatment of GW823093C.~   "
243209|NCT00370929|"~     Epileptic seizures may occur at times of stress and commonly increase life stress. This study~     will evaluate whether meditation improves seizure control and quality of life for individuals~     with uncontrolled epilepsy.~   "
243210|NCT00370916|"~     Patient transfer between sites of care is regular practice during an episode of care in our~     current health care system. Yet inter-site transfer is associated with lapses in care quality~     that adversely affect patient outcomes. A common iatrogenic harm precipitated at the time of~     transfer is harm from drug prescribing, or adverse drug events (ADEs). In this study we will~     evaluate a medication reconciliation tool developed to help providers make effective~     prescribing decisions at the time of transfer between VA sites of care (Improved Prescribing~     after Transfer (IPT)). We will evaluate the quantitative effectiveness of the tool in~     reducing transition drug risk and ADEs. We additionally will conduct focus group discussions~     and cognitive task analysis among end-users to better understand how providers make~     drug-prescribing decisions at the time of transfer and to assess factors influencing~     effective use of the tool.~   "
243211|NCT00370903|"~     The purpose of this retrospective study is to determine if there is an increase in postpartum~     depression (PPD) among women who undergo an emergency cesarean section as opposed to a~     planned cesarean section. We will analyze the hospital and clinic medical records of~     postpartum women who delivered by cesarean section (CS) at Tulsa Regional Medical Center~     between January 1, 2003, and June 1, 2005, and who obtained their postpartum care at the OSU~     Ob/Gyn Clinic in Tulsa, Oklahoma. We will record whether the cesarean was planned or~     emergent, and we will note the score they received on the Edinburgh Postnatal Depression~     Scale when they came to the clinic for their four-week postpartum visit. A score of 12 or~     lower on the EPDS will be considered not depressed, and a score of 13 or higher will be~     considered depressed. Numbers of depressed patients will be compared among the two types of~     cesarean sections and analyzed for statistical differences using the chi-squared method of~     analysis.~   "
243212|NCT00370890|"~     The purpose of this trial is to study the benefit of adjuvant chemotherapy using gemcitabine~     and cisplatin in high risk NPC patients with residual EBV DNA following primary radiotherapy~     with or without concurrent cisplatin.~   "
243213|NCT00370877|"~     The aim of this clinical research project is to evaluate the use of the recombinant human~     activated factor VII (rhFVIIa), given as a salvage therapy, in women with a dramatic~     postpartum hemorrhage still ongoing after all the currently available medical and surgical~     treatments. We are going to compare its early use, before elective surgery or arterial~     embolization, to its late use, after embolization or surgery, before salvage hysterectomy.~   "
243214|NCT00370864|"~     The World Health Organisation has warned that an influenza pandemic is inevitable. The avian~     influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic.~     Children are likely to be a special target group for vaccination; therefore, this study will~     test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.~   "
243215|NCT00370851|"~     In this study we intend to evaluate the outcome of intravitreal avastin on improving the~     visual acuity and macular edema and late complications of BRVO like NVD and NVE~   "
243216|NCT00370838|"~     The goal of this study is to confirm that levetiracetam has a better tic-suppressing profile~     than that of the widely used tic-suppressing medication, clonidine. More specifically, the~     investigators hypothesize that in a 15 week placebo run-in, double-blind, medication~     cross-over trial; levetiracetam will be more effective and have fewer side-effects than~     clonidine.~   "
243217|NCT00370825|"~     The investigators are using a sequential design to combine miltefosine and AmBisome in~     different doses.~   "
243218|NCT00370812|"~     This is a randomized clinical trial study to identify the role of AMT (amniotic membrane~     transplantation) in treating epithelial defect, symblepharon prevention preventing corneal~     vascularization and opacity decreasing pain and improving visual acuity, and patients with~     acute chemical burns.~   "
243219|NCT00370799|"~     To demonstrate clinically significant improvements or lack thereof in the caudal epidural~     patients with our without steroids.~      To evaluate differences in outcomes in patients receiving steroids compared to those patients~     randomized to the local anesthetic group who did not receive steroids.~      To assess improvements among patients and compare steroid groups with each other and local~     anesthetic group.~      To evaluate and compare the adverse event profile in all patients~   "
243220|NCT00370786|"~     To evaluate the effect of bevacizumab for treatment of non-AMD choroidal neovascularization~     (CNV); eg:angioid streaks, ocular histoplasmosis, high myopia, idiopathic,etc~   "
243221|NCT00370773|"~     This study will systematically evaluate the programming parameters of the Precision Spinal~     Cord Stimulation Device to optimally relieve pain while minimizing any uncomfortable side~     effects.~   "
243222|NCT00370760|"~     To evaluate the efficacy of oral colchicine combined with intraoperative infusion of~     dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of~     established proliferative vitreoretinopathy (PVR)~   "
243223|NCT00370747|"~     The purpose of this study is to determine whether ecabet ophthalmic solution is an effective~     treatment for dry eye syndrome~   "
243224|NCT00370734|"~     In active phase of thyroid eye disease some patients have obvious upper lid retraction , and~     sometimes exposure keratopathy .To date there is not any standard treatment for this~     situation . We are going to compare the natural course of the upper lid retraction with~     injection of botulinum toxin A injection to upper lid percutaneously.~   "
243225|NCT00370721|"~     To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in~     cases with the signs of active progressive PDR~   "
243226|NCT00370708|"~     In this study we are trying to compare the safety and financial benefit of starting the~     realimentation early versus conventional oral intake following the Cesarean surgery in Iran.~   "
243227|NCT00370695|"~     The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using~     the Precision implantable neurostimulation device for chronic and intractable back pain in~     subjects who are not candidates for surgery or who have chosen to seek alternative therapy.~   "
243228|NCT00370682|"~     This descriptive study will evaluate the safety and immunogenicity of different formulations~     of the WRAIR dengue vaccine compared to a placebo.~   "
243229|NCT00370669|"~     to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone~     acetonide with laser photocoagulation on clinically significant macular edema (CSME)~   "
243230|NCT00370656|"~     The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and~     amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by~     Brief Pain Inventory (BPI).~   "
243231|NCT00370643|"~     The purpose of the study is to seek if there is difference to state glucose level in~     80-120mg/dl or 200mg/dl in patients submitted to open heart surgery~   "
243232|NCT00370630|"~     In this study we intend to evaluate and compare the outcomes of intravitreal avastin versus~     avastin and triamcinolone on improving the visual acuity and macular edema and late~     complications of CRVO like NVI and NVG.~   "
243233|NCT00370617|"~     Chronic hepatitis C virus (HCV) infection is associated with an increased risk for the~     development of type 2 diabetes and HCV infection itself may promote insulin resistance,~     irrespective of the severity of liver disease.~      Insulin resistance seems to be genotype specific and may play a role in fibrogenesis in~     chronic hepatitis C.~      In an “in vitro” model, increased levels of insulin may promote increased HCV replication.~      RATIONALE Decreased insulin resistance and reduced hyperinsulinemia may facilitate the~     efficacy of anti-viral drugs on HCV replication.~   "
243234|NCT00370604|"~     The purpose of this study is to determine the effect of 19g versus =>18g traditional~     Tuohy-type epidural needles on the incidence and severity of postdural puncture headache~     (PDPH).~   "
243235|NCT00370591|"~     Comparison of two asthma treatments by lung function measures.~   "
243236|NCT00370578|"~     Early promising data are published focusing on the role of manual thrombus aspiration devices~     in patients with ST segment elevation (STEMI).~      The aim of our single center randomized study is to evaluate the early and late effect of~     thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI~     population.~      Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may~     give early and late advantages compared to the standard primary PCI technique.~   "
243237|NCT00370565|"~     To assess the impact on glucose control by inhaled insulin alone or added to two oral~     anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral~     anti-diabetic agents.~   "
243238|NCT00370552|"~     The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is~     effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy~     in participants with metastatic breast cancer. The study will also assess the safety of this~     combination treatment.~   "
243239|NCT00370539|"~     To compare the efficacy and safety of photodynamic therapy (PDT) combined with intravitreal~     bevacizumab versus combination of photodynamic therapy , intravitreal bevacizumab and~     intravitreal triamcinolone for neovascular AMD.~   "
243240|NCT00370526|"~     The literature shows that approximately 40% of individuals who receive a cardiac~     resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not~     have a clinical benefit from the device. The HEAL-HF protocol will compare the outcomes of~     conventionally placed CRT devices with magnetically placed CRT devices by assessing~     hemodynamic parameters during the magnetic placement of the left ventricular (LV) lead.~   "
243241|NCT00370513|"~     Liver cancer is a good target for anti-angiogenic treatments such as pazopanib. The effect of~     pazopanib in patients with liver cancer are unknown. This study is designed to evaluate the~     safety, tolerability and best dose of pazopanib to be given to patient with liver cancer.~   "
243242|NCT00370500|"~     BACKGROUND:~      Epigenetic modifications such as DNA-methylation and histone acetylation are known to be~     involved in the pathophysiology of schizophrenia. Aim of the present study is to investigate~        1. whether differences in the methylation pattern of the promoters of dopaminergic genes~          exist between schizophrenic patients and healthy controls and~        2. whether treatment with the second generation antipsychotic quetiapine leads to changes~          in the methylation pattern of those genes in patients suffering from schizophrenia.~      STUDY DESIGN AND METHODS:~      50 male patients and 50 male controls are to be enrolled into the study. Patients will be~     treated with quetiapine for 3 weeks. Blood samples will be drawn before treatment and after~     three weeks to measure DNA-methylation status. Clinical characterisation includes PANSS,~     AIMS, BDI. Healthy probands will not be treated.~   "
243282|NCT00369967|"~     We hypothesize that using quick start initiation of the contraceptive vaginal ring in~     adolescents seeking birth control will improve compliance compared to traditional start. We~     will conduct a randomized controlled trial comparing quick start to traditional start~     initiation of the contraceptive vaginal ring in adolescents seeking birth control. The~     primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes~     include abnormal bleeding, product satisfaction, and adverse events.~   "
243243|NCT00370487|"~     There have been no studies in developing countries assessing the safety of midlevel providers~     (MLP) compared to physicians in performing first-trimester manual vacuum aspiration abortion.~     In South Africa and Viet Nam, MLP (midwives and physician assistants) are trained and~     accredited to perform first trimester abortions to increase women’s access to safe abortion~     services. To assess the safety of abortions performed by midlevel provider compared to~     physicians, complication rates of first-trimester manual vacuum aspiration are compared~     between types of providers in the two countries. We test the null hypothesis that the two~     types of providers provide abortions equally safely.~   "
243244|NCT00370474|"~     Magnetic navigation will permit delivery of the LV lead tip to a prospectively defined~     location more efficiently and in a higher proportion of patients than is possible with manual~     navigation.~   "
243245|NCT00370461|"~     In Ontario, most people who experience a cardiac arrest at home (when their heart stops~     beating) only receive basic life support from Primary Care Paramedics (PCPs) and all are~     transported to the hospital. Most are pronounced dead by the emergency physician as the mean~     survival rate for these patients is 5%. Allowing Primary Care Paramedics to use a termination~     of resuscitation guideline would identify futile cases for which further resuscitation is~     unwarranted and decrease the number of patients being transported to the emergency department~     (ED) for pronouncement.~      There are numerous advantages to this strategy; first, it may improve the efficiency of the~     ED because cardiac arrest patients require immediate attention that is diverted from patients~     who have a better chance at survival. Second, the risk of injury and the monetary costs for~     the paramedic and the public would be minimized with fewer light and sirens transports~     which are known to be hazardous to motorists, pedestrians, and Emergency Medical Services~     (EMS) personnel.~      For each cardiac arrest, PCPs will respond to the call as usual and implement standard basic~     life support cardiac arrest protocols. Patients are then categorized according to the~     termination of resuscitation recommendations:~        1. no return of spontaneous circulation is achieved (no heartbeat);~        2. no shock was given prior to transport; and~        3. the arrest (when the heart stops beating) was not witnessed by EMS personnel.~      If all of these criteria are true, the PCP will contact the hospital and the decision by the~     emergency physician will then be made to stop life saving measures (terminate resuscitation)~     in the home or continue with life support and transport the patient to the local emergency~     department.~      This study aims to document the usefulness of the termination of the resuscitation guideline~     in decreasing the rate of transport of out-of-hospital cardiac arrest patients to the ED.~     Secondary aims of this implementation study will be to describe the rates of erroneous~     application of the guideline. The comfort of use of the rule among paramedics and base~     hospital emergency physicians will be described.~   "
243246|NCT00370448|"~     The purpose of this study is to determine whether school-based social support systems are~     effective in preventing suicide in medical students.~   "
243247|NCT00370435|"~     This is a study of GW274150, an iNOS (inducible nitric oxide synthase) inhibitor to~     investigate safety, tolerability and pharmacokinetics (PK) in the rheumatoid arthritis (RA)~     population (greater than 50 years). Safety, tolerability and PK of GW274150 in an adult and~     elderly population have not yet been determined. Therefore this study is designed to ensure~     that 90mg GW274150 will be safe and well-tolerated in this adult and elderly RA patient~     population on methotrexate. The assessments will include pharmacokinetics (PK), liver~     function tests and creatinine clearance.~      This study will provide confidence that a single 90mg dose of GW274150 results in exposure in~     RA subjects similar to that expected from healthy volunteers and asthmatics.~   "
243248|NCT00370422|"~     The purpose of this study is to compare the efficacy and safety of intravitreal injection of~     bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory~     diabetic macular edema.~   "
243249|NCT00370409|"~     Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft~     formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by~     regressing the fibrovascular tuft. This study will detect the safety and efficacy of~     cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized~     diabetic eyes.~   "
243250|NCT00370396|"~     This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of~     GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of~     age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553.~     Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization~     course in study 105553. The immune response to a booster dose of GSK Biologicals'~     pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not~     primed with GSK Biologicals' vaccine but with Prevenar™.~      The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal~     conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children~     primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of~     children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal~     conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib~     vaccine.~   "
243251|NCT00370383|"~     Patients ≥ 70 years of age with locally advanced unresectable or metastatic non-small cell~     lung cancer (NSCLC) frequently do not receive systemic cytotoxic chemotherapy due to concerns~     regarding their inability to tolerate treatment. Epidermal growth factor receptor (EGFR)~     tyrosine kinase inhibitors (TKIs) are agents with favorable toxicity profiles that have shown~     activity in patients with NSCLC. Erlotinib as a single-agent is currently approved for the~     treatment of patients with NSCLC whose disease has progressed following one prior course of~     chemotherapy and is currently being evaluated in NSCLC patients who have not received prior~     systemic treatment. However, when studied with combination chemotherapy in the first-line~     setting, continuous daily administration of erlotinib did not result in improved patient~     survival. Further clinical and in vitro data suggest that the sequencing of cytotoxic~     chemotherapy with EGFR TKIs is important to maximize their therapeutic potential when~     administered in combination.~      Satraplatin is an oral, investigational anticancer drug that is a member of the~     platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven~     to be one of the most effective classes of anticancer therapies. Unlike the currently~     marketed platinum-based drugs, satraplatin can be given orally and is currently being~     evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone~     refractory prostate cancer.~      The rationale for this study is to develop an active and well-tolerated oral regimen for~     patients ≥ 70 years of age with NSCLC. Administration of the study drugs will be sequenced~     with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle.~     The primary endpoint will be progression-free survival (PFS). Patients will be randomized to~     treatment with either the experimental regimen or single-agent continuous erlotinib.~   "
243252|NCT00370370|"~     To compare the efficacy and safety results of intravitreal bevacizumab alone with bevacizumab~     + triamcinolone acetonide in neovascular AMD.~   "
243253|NCT00370357|"~     The purpose of this study is to determine if SPL7013 Gel (VivaGel™) is safe when applied~     topically once a day for seven consecutive days to the shaft and glans of the penis in~     healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile~     epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the~     systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel,~     and the acceptability of the study products to the male volunteers.~   "
243254|NCT00370344|"~     The trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole)~     laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two~     groups of surgeons, each group being trained for one of the two methods.~   "
243255|NCT00370331|"~     The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of~     eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting~     dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety~     and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a~     randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety~     and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for~     six months in adult subjects with previously treated chronic ITP. Subjects will be randomized~     2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP~     medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects~     will receive study medication for 6 months, during which the dose of study medication may be~     adjusted based upon individual platelet counts. In addition, subjects may taper off~     concomitant ITP medications and may receive any rescue treatments as dictated by local~     standard of care. After discontinuation of study medication, subjects will complete follow-up~     visits at weeks 1, 2, 4 and months 3 and 6.~   "
243256|NCT00370318|"~     The purpose of this trial is to assess if the rate of febrile reactions following the~     co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered~     when paracetamol is given prophylactically.~   "
243257|NCT00370305|"~     The purpose of this study is to determine whether the insulin sensitizing effects of~     rosiglitazone were accompanied by changes in 11ß-HSD1 expression and activity in different~     tissues. Furthermore the metabolic and hormonal effects of PPAR gamma stimulation by~     rosiglitazone will be analysed in several tissues.~   "
243258|NCT00370292|"~     Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed~     monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some~     biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to~     monitor the blood values of these biomolecules at different time intervals, to optimize the~     synergism between pemetrexed and gemcitabine.~   "
243259|NCT00370279|"~     To compare the visual and anatomical outcomes and complications of four surgical techniques~     (1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy~     with encircling band, 4- triamcinolone assisted vitrectomy) for management of pseudophakic~     and aphakic retinal detachment~   "
243260|NCT00370266|"~     The purpose of this study is to determine whether intraocular injection of triamcinolone is~     effective in the treatment of macular edema in acute branch retinal vein occlusion.~   "
243261|NCT00370253|"~     The purpose of this study is to determine whether noradrenalin is as effective and safe as~     terlipressin in the treatment of hepatorenal syndrome~   "
243262|NCT00370240|"~     The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of~     ropivacaine) to prevent chronic pain after breast surgery for cancer.~   "
243263|NCT00370227|"~     This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of~     the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at~     12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate~     vaccine in study 105553. Antibody persistence will be evaluated at 8-10 months after~     completion of the 3-dose immunization course in study 105553. The immunogenicity, safety and~     reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin~     with the pneumococcal conjugate vaccine between 12-16 months of age.~      The study has 3 groups.~        -  The 1st group will receive the booster dose of pneumococcal conjugate vaccine + 1st dose~          of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa™+ 2nd dose of~          MMRV vaccine at 14-16 mo of age.~        -  The 2nd group will receive the booster dose of Infanrix hexa™ + 1st dose of MMRV vaccine~          at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine + 2nd dose of~          MMRV vaccine at 14-16 mo of age.~        -  The 3rd group will receive the booster dose of pneumococcal conjugate vaccine + the~          booster dose of Infanrix hexa™ at 12-14 mo. Subjects will be offered one dose of~          Priorix™ and Varilrix™ at 14-16 mo of age, outside the study.~   "
243264|NCT00370214|"~     The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course~     and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive~     consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria~     at participating institutions will be enrolled. Participating patients will be followed for a~     minimum of five years from the time of enrollment.~   "
243265|NCT00370201|"~     This clinical trial will test the efficacy and safety of oral colchicine in prevention of~     proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment~   "
243266|NCT00370188|"~     The quest for an effective medication therapy for problem gambling remains an important~     priority for the problem gambling treatment research field. While several medications have~     been evaluated in controlled clinical trials, no medication has been shown to unequivocally~     reduce gambling behaviour and, to date, no medication has been approved for treating this~     disorder. Recently, topiramate, indicated for the treatment of seizure disorders, has shown~     some promise as a medication therapy for problem gambling. In this project, the efficacy of~     topiramate will be evaluated in a placebo-controlled clinical trial, the first study to do~     so. The interaction of the effects of the medication and gambling sub-type will be examined~     to determine whether the efficacy of topiramate is correlated with the specific~     biopsychosocial history of the gambler.~   "
243267|NCT00370162|"~     The purpose of this study is to demonstrate the safety of the gynaecological formulation in~     normal and usual usage condition.~   "
243268|NCT00370149|"~     The primary purpose of the study is to determine if a therapeutic difference exists between~     central venous catheters impregnated with minocycline and rifampin and conventional catheters~     not impregnated with antibiotics when used in children at high risk for bloodstream~     infections (CABSI) after cardiac surgery.~   "
243269|NCT00370136|"~     The purpose is to evaluate,in 20 patients, if the sentinel node(s) in melanoma can be~     detected by lymph contrast ultrasound. In comparing the patients will also get~     lymph-scintigraphy and sentinel node detection wiht blue dye.~      The goal is to improve the method for detecting sentinel node(s) in melanoma.~   "
243536|NCT00366626|"~     The purpose of this study is to determine whether naltrexone (an opiate blocking agent~     approved for the treatment of alcohol dependence) is more effective in the reduction of~     alcohol craving and drinking compared to placebo in individuals with particular genetic~     predisposition.~   "
243270|NCT00370123|"~     Endometriosis is a chronic disabling inflammatory disease which effects 15-20% of women in~     their reproductive life.~      In patients suffering from endometriosis retrograded menstrual cells induce an inflammatory~     response.Endometriosis has also been considered to be an autoimmune disease, owing to the~     presence of auto antibodies, the association with other autoimmune diseases and recurrent~     immune-mediated abortion.~      We aim to study this aberrant regulation of endometrial cell apoptosis by investigating the~     peripheral blood immune system of patients suffering from endometriosis.~      Hypothesis:~      We hypothesized that immune peripheral mononuclear cells of patients suffering from pelvic~     endometriosis react differently to eutopic endometrial cells than matched control women~     group. This difference could be study on a molecular, antigenic and/or apoptotic cycle gene~     expression. We also hypothesized that a deficiency of regulatory T cells is associated with~     the progression of endometriosis.~   "
243271|NCT00370110|"~     Itopride is a new compound that is already marketed in Japan and in some countries of Eastern~     Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis.~     Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea~     and vomiting following ingestion of a meal. This is a randomized, parallel group, two dose~     double blind, placebo-controlled study evaluating the effects of itopride (100 mg and 200 mg~     three times daily) and placebo on gastric motor and sensory functions in healthy volunteers.~   "
243272|NCT00370097|"~     The purpose of this study is to address an Food Drug and Administration (FDA) request to~     provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following~     administration of fluticasone propionate HFA.~   "
243273|NCT00370084|"~     Itopride is a new compound that is already marketed in Japan and in some countries of Eastern~     Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis.~     Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea~     and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects~     of Itopride on gastric motor function and glycemia in patients with diabetes.~   "
243274|NCT00370071|"~     The purpose of this study is to determine if the study drug is effective and safe in the~     treatment of Multiple Sclerosis (MS) in patients of Chinese origin.~   "
243275|NCT00370058|"~     Elevated homocysteine levels are associated with depression and cognitive impairment. When~     depression ameliorates due to treatment, homocysteine serum levels often normalize. Aim of~     the present study is to investigate, whether repeated ECT treatment leads to changes in~     homocysteine levels and if these changes are associated with the occurrence of cognitive~     impairment after ECS.~      10 patients suffering from therapy-resistant depression shall be enrolled. Patients are~     treated with repeated ECT (three times the week). Before, directly after and one day after~     ECT treatment, blood samples are drawn and patients receive cognitive testing. Depressive~     symptomatology is checked with different rating scales.~   "
243276|NCT00370045|"~     The purpose of this study is to compare levels of clot formation (platelet aggregation),~     markers of heart muscle damage, and inflammation in two groups undergoing percutaneous~     coronary stent implantation. The first group will be on a regimen of high-dose clopidogrel~     used in combination with bivalirudin plus eptifibatide, and the second group will be on a~     regimen of high-dose clopidogrel with bivalirudin alone. Clinical outcomes will be determined~     up to one year after enrollment.~   "
243277|NCT00370032|"~     This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs~     placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS)~     patients.~   "
243278|NCT00370019|"~     This study will determine whether giving estrogen replacement therapy through an estradiol~     patch can improve ovulation rates in women with spontaneous premature ovarian failure. The~     ovaries are glands in women that produce female hormones and normally release an egg once a~     month. In women with spontaneous premature ovarian failure, the ovaries stop working too~     soon. Women with this disorder have abnormally high levels of leuteinizing hormone (LH) in~     their blood, which impedes normal ovulation. In some women, estrogen replacement can suppress~     LH levels to the normal range.~      Women between 18 and 40 years of age with premature ovarian failure may be eligible for this~     4-month study. Participants receive either standard hormone replacement therapy, consisting~     of an estradiol patch and progestin tablets, or placebo. The placebo group receives patches~     and tablets that look the same as those for the group with active treatment but they contain~     no hormone. All participants wear the patch every day and take the tablets the first 12 days~     of each month. In addition to taking the study drug, participants have blood drawn once a~     week for the 16 weeks of the study.~      At the end of the trial, women who were in the placebo group are offered the opportunity to~     receive the estrogen patch and progestin therapy for another 16 weeks and continue the blood~     tests to determine if they ovulate on this treatment.~   "
243279|NCT00370006|"~     Objectives of this trial are to:~        1. Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne~          challenge (3000 pfu) in healthy CMV-seronegative volunteers who received VCL CT02~          administered ID or IM 9 to 15 months previously as measured by: 1) ELISA and/or~          virus-neutralizing antibody titers for gB; 2) T-cell IFN-g ELISPOT; 3) T-cell~          proliferation assays (CFSE) for IE1, pp65, and/or gB; and possibly 4) cytokine and~          phenotypic flow cytometry responses to pp65, IE1, and/or gB.~        2. Evaluate the safety safety of Towne challenge in healthy CMV-seronegative adult subjects~          who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02)~          administered intramuscularly (IM) or intradermally (ID).~      Our hypothesis is that the immune response to Towne vaccine 3000 pfu challenge after VLC-CT02~     priming will be greater than that after Towne vaccination alone (concurrent controls will be~     administered Towne alone in a concurrent, companion trial).~   "
243280|NCT00369993|"~     Spacers are used by people with respiratory diseases who have problems using MDIs (metered~     dose inhalers). This study used fluticasone propionate/salmeterol to look at the~     pharmacokinetic profiles produced by different spacers in their washed and un-washed states.~   "
243281|NCT00369980|"~     L-[3-18F]-α–methyltyrosine (FMT) is amino-acid tracer for positron emission tomography (PET),~     and is used for tumor detection because malignant tumor cells accumulate 18F-FMT based on the~     increased expression of amino-acid transporter. This study was conducted to investigate a~     usefulness of 18F-FMT PET in combination with 18F-FDG PET for the diagnosis of sarcoidosis in~     patients with suspected malignancy.~   "
243283|NCT00369954|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) and giving them in different~     ways may kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine~     together with carboplatin works in treating patients with persistent or recurrent ovarian~     epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that responded to~     previous cisplatin or carboplatin.~   "
243284|NCT00369941|"~     This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in~     combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected~     patients not previously treated.~   "
243285|NCT00369928|"~     This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group,~     multicenter study to evaluate the safety, efficacy, and PK of oral administration of~     PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of~     PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening~     visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and~     anti-cytokine therapies except MTX. After the washout period, patients determined to be~     eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or~     placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after~     the last treatment visit. The primary efficacy endpoint will be the proportion of patients~     meeting the ACR 20 response criteria after 12 weeks of treatment.~   "
243286|NCT00369915|"~     A previous study showed that the intravenous administration of scopolamine produces~     antidepressant effects. This study is designed to determine if other routes of administration~     of scopolamine produce antidepressant effects.~   "
243287|NCT00369902|"~     The Purpose of this study is to evaluate whether cognitive and emotional components take part~     in the positive acupuncture effect on pain.~   "
243288|NCT00369889|"~     The purpose of this study is to determine the rate of response with the combination of~     erlotinib and bevacizumab in previously treated patients with thymoma or thymic carcinoma,~     and to determine potential molecular markers that may predict response to therapy in patients~     with thymoma or thymic carcinoma.~   "
243289|NCT00369876|"~     Anorexia in children with burn injury is a common phenomenon. The study is searching for the~     origin of the anorexia in those children. The study correlates between the level peptides of~     the immune and the endocrine systems and the length of the anorexia.~   "
243290|NCT00369863|"~     To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory~     diabetic macular edema.~   "
243291|NCT00369850|"~     RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help~     measure bone loss in women receiving treatment for breast cancer. The test results may help~     doctors plan better treatment.~      PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women~     with breast cancer receiving treatment in clinical trial IBCSG-1-98.~   "
243292|NCT00369837|"~     The purpose of this study was to determine the safety of clevidipine for treating severely~     elevated blood pressure, defined as systolic (SBP) >180 mmHg and/or diastolic blood pressure~     (DBP) >115 mmHg assessed on 2 successive occasions 15 minutes apart at baseline, in patients~     with or without major organ injury, particularly with respect to controlled dose adjustment~     to desired effect and prolonged continuous infusion. Enrollment of patients into the study~     was to continue until the target goal of 100 patients with at least 18 hours of continuous~     clevidipine treatment, including a minimum of 50 patients with acute or chronic end-organ~     injury, was met.~   "
243293|NCT00369824|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and~     thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical~     cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents~     platform. Therefore, this Phase 3b study is designed to evaluate the safety and~     immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine~     (580299) as compared to the administration of any of the vaccines alone.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
243294|NCT00369811|"~     To evaluate the analgesic efficacy of oxycodone and fentanyl in the treatment of~     postoperative pain after laparoscopic cholecystectomy.~   "
243295|NCT00369798|"~     The primary purpose of this protocol is to compare PDE4 levels before and after starting a~     selective serotonin reuptake inhibitor (SSRI) sertraline, citalopram or escitalopram in~     unmedicated depressed patients. The secondary purpose is to compare PDE4 levels between~     unmedicated depressed patients and healthy subjects.~   "
243296|NCT00369785|"~     RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of~     life in patients who have undergone radiation therapy for brain tumors. It is not yet known~     whether donepezil is more effective than a placebo in lessening side effects of radiation~     therapy in patients with brain tumors.~      PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in~     lessening side effects of radiation therapy compared with a placebo in patients who have~     undergone radiation therapy for brain tumors.~   "
243297|NCT00369772|"~     To assess the effect of Aranesp on the hemoglobin of CRI subjects who are recombinant human~     erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy~   "
243298|NCT00369759|"~     The primary objective of this study is to describe the incidence of RSV-associated LRI among~     infants <1 year of age presenting to the ED during selected shoulder months.~   "
243299|NCT00369746|"~     The purpose of this study is to determine if having an alcohol use disorder affects recovery~     from depression, and also whether recovery from depression in patients who have alcohol use~     disorders is also accompanied by improvement in the alcohol use disorder.~   "
243300|NCT00369733|"~     To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant~     human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.~   "
243336|NCT00369239|"~     The purpose of this research study is to see how well patients in an early phase of their~     illness respond to treatment and whether this depends on how well they functioned socially,~     academically and vocationally before becoming ill. The study also examines whether patients~     with more insight into their illness have better outcomes.~   "
243301|NCT00369720|"~     We propose a preliminary trial to evaluate the safety and efficacy of using more restricted~     oxygen during resuscitation for VLBW infants than is utilized currently in an effort to~     reduce the oxidant stress of such treatment, and to possibly reduce associated multi-system~     organ related dysfunction.~      In attempting to design a trial comparing higher versus lower oxygen during neonatal~     resuscitation with the potential for benefit to the enrolled infants, and a minimal level of~     risk, and acknowledging that the use of Room Air may be considered premature in view of the~     lack of any safety data in this population, we are proposing to utilize an oxygen blender and~     a pulse oximeter in the delivery room in the treated group. The treated group will have their~     fraction of inspired oxygen increased from 21%, as necessary, to achieve a target oxygen~     saturation of 85 to 90% at 5 minutes of life, compared with the standard of care group who~     will receive 100% oxygen without the use of a blender, which is the current approach in most~     centers in this country. The targeted saturation of 85% will provide enough oxygen to treat~     any ventilation/perfusion mismatch, while exposing the infants to significantly less inspired~     oxygen.~      Hypothesis: We hypothesize that the use of restricted inspired oxygen during resuscitation~     will result in a significant reduction in oxidant stress without any harmful clinical~     effects.~   "
243302|NCT00369707|"~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells~     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Giving bortezomib together with rituximab may kill more cancer cells.~      This phase II trial is studying how well giving bortezomib together with rituximab works as~     first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma.~   "
243303|NCT00369694|"~     The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as~     72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been~     controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to~     moderate risk variceal bleed patients and hence can save cost and may decrease length of~     hospital stay especially in the I.C.U or high dependency units.~   "
243304|NCT00369681|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving rituximab together with combination chemotherapy may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV~     Hodgkin's lymphoma.~   "
243305|NCT00369668|"~     The purpose of this study was to determine the effect of two amounts of treatment therapy on~     post stroke motor recovery in the arms. The therapy is bilateral movement training combined~     with electrical stimulation on the impaired limb.~   "
243306|NCT00369655|"~     This phase II trial is studying how well VEGF Trap works in treating patients with metastatic~     breast cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the~     tumor~   "
243307|NCT00369642|"~     Pediatric obsessive-compulsive disorder (OCD) is a chronic and often disabling illness with~     an estimated lifetime prevalence of 1 to 3%. Pediatric OCD is associated with significant~     social, educational, and familial impairment, as well as comorbid emotional and behavioral~     disturbances that serve to complicate the prognosis of the illness and treatment outcome.~     While limited open treatment trials and one controlled trial have demonstrated~     cognitive-behavioral therapy (CBT) to be effective for pediatric OCD, controlled trials are~     lacking in the literature. There are a number of incremental benefits that an intensive~     program for OCD may offer. First, existing outpatient interventions typically achieve~     treatment gains over a 15 to 20 week period. The present program typically lasts between 2 to~     4 weeks, and thus may present as a more timely, cost-effective, and efficient means of~     treatment for some individuals. Second, given that many children and adolescents may not have~     access to mental health professionals who are trained in empirically grounded interventions~     for OCD, the present treatment setting allows youth to receive appropriate, state of the art~     care. Finally, evidence suggests that daily CBT may be particularly effective in treating~     children who have been refractory to prior treatments (e.g., medication or once per week~     CBT). Prior to treatment, all consenting families will be randomly assigned to either the~     treatment condition or a three-week wait-list control condition. Those families randomized to~     the wait-list condition will receive treatment immediately after the three weeks are~     completed. The treatment group will be administered all measures immediately before~     treatment, immediately after treatment, and three months after treatment. The wait-list~     control condition will be administered all measures upon starting the wait-list period,~     immediately following the conclusion of the three-week wait-list period, and after the~     treatment program has finished. The purpose of the current study is to evaluate the efficacy~     of daily cognitive-behavioral treatment for pediatric OCD.~   "
243308|NCT00369629|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving gemcitabine together with pemetrexed disodium may kill more~     cancer cells.~      PURPOSE: This was planned as a phase I/II trial studying the side effects and determining the~     best dose of gemcitabine hydrochloride when given together with pemetrexed disodium.~     Unfortunately, due to a lack of funding, the phase II portion was never conducted.~   "
243309|NCT00369616|"~     The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb.~     Upon vaccination, the smoker will generate antibodies directed against free nicotine. The~     antibodies will bind nicotine and prevent its passage into the brain. The successfully~     vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle~     of nicotine addiction.~   "
243310|NCT00369603|"~     The purpose of this study is to determine whether standard medications approved for~     Alzheimer's disease treatment differ in their action on brain functioning and whether any~     observed brain activity differences as result of treatment are associated with particular~     patterns of dementia improvement or reduced decline.~   "
243311|NCT00369590|"~     This phase II trial is studying how well VEGF Trap works in treating patients with recurrent~     malignant or anaplastic gliomas that did not respond to temozolomide. VEGF Trap may stop the~     growth of malignant or anaplastic gliomas by blocking blood flow to the tumor.~   "
243353|NCT00369018|"~     The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of~     cervical precancerous lesions (dysplasia) in women that are referred for conisation~     (surgery).~   "
243354|NCT00369005|"~     The purpose of this study was to determine whether restrictive guidelines for red blood cell~     (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse~     consequences.~   "
243312|NCT00369577|"~     The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the~     treatment of acute agitation in schizophrenic patients. The study will be conducted in 120~     agitated schizophrenic patients - either newly admitted to a hospital setting or a research~     unit for acute agitation or already in hospital for chronic underlying conditions. Patients~     meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to~     Staccato Placebo. Following administration of study drug, assessment of agitation state will~     be conducted at serial time points using standard agitation scales over a 24 hour period.~   "
243313|NCT00369564|"~     RATIONALE: Glutamic acid may help lessen or prevent nerve damage caused by vincristine. It is~     not yet known whether glutamic acid is more effective than a placebo in preventing nerve~     damage in patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute~     lymphoblastic leukemia, or non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying glutamic acid to see how well it works~     compared to a placebo in reducing nerve damage caused by vincristine in young patients~     receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or~     non-Hodgkin's lymphoma.~   "
243314|NCT00369551|"~     This phase I trial studies how well giving bevacizumab together with paclitaxel, carboplatin,~     and radiation therapy to the chest works in treating patients with locally advanced non-small~     cell lung cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving bevacizumab together with paclitaxel,~     carboplatin, and radiation therapy may kill more tumor cells.~   "
243315|NCT00369538|"~     Chronic glomerular diseases are one of the main causes leading to end stage renal disease~     (ESRD). Hypertension and proteinuria are two modifiable factors promoting the progression of~     ESRD. Podocyte are terminally differentiated epithelial cells and play a central role in the~     progression of chronic kidney disease and in the development of glomerulosclerosis. The~     presence of podocyte in urines (podocyturia) has been documented by several teams with~     continuous and regular podocyturia during glomerular disease. This facts suggests that~     podocyturia could become a marker of podocyte loss and glomerular damage. In our university~     hospital, we developed a technique to evaluate the number of microparticles (cellular~     fragments) in different biologic samples. The podocytary origin of microparticles will be~     determinated thanks to specific antibodies. The aim of the present study is: i) to quantify~     podocyturia during glomerular nephropathies by dosing podocyte microparticles ii) to study~     the relationship between podocyturia and other biologic markers such as proteinuria iii) to~     evaluate the effect of angiotensine 2 blockage on podocyturia. This is an open-labelled~     randomized monocenter cross-over study. Twenty subjects with hypertension and glomerular~     nephropathy characterized by proteinuria and a normal or slightly altered renal function will~     be included. Patients will be treated successively by an angiotensin receptor blocker (ARB),~     losartan and by a thiazide, hydrochlorothiazide, (after a wash out period). We will study the~     impact of these two therapies on podocyturia. Results will be compared with others markers~     like proteinuria (and its selectivity). We may finally dispose of a non invasive urinary~     marker of podocyte lesions responsible for glomerulosclerosis and for ESRD progression.~     Moreover mechanism of nephroprotection of the ARB may be more comprehensive.~   "
243316|NCT00369512|"~     This is a phase II study designed to study the effectiveness of combined radiotherapy and~     erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk~     for recurrence. Participants enrolled in the study will be evaluated by a head and neck~     surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be~     performed after participant enrollment in the study for histological confirmation and for~     molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib~     at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical~     resection. Following planned surgical resection, the participant will begin Erlotinib therapy~     and radiotherapy at the same time and within 4-8 weeks of the surgical resection.~   "
243317|NCT00369499|"~     The primary objective of this Study is to compare the effect of transcatheter device closure~     of atrial shunting to a non-closure control group over a period from cessation of procedure~     related medication at 3 months until 9 months post randomization by determining the~     proportion of patients that experience a 50% or more reduction in the baseline monthly~     migraine attack frequency in each group.~   "
243318|NCT00369486|"~     The study involves the enrollment of patients over 18 years of age with diabetic macular~     edema involving the center of the macula who have not already been given maximal laser~     treatment.~      Patients with one study eye will be randomly assigned (stratified by prior laser) with equal~     probability to one of five treatment groups:~        1. Focal laser photocoagulation (modified ETDRS technique)~        2. Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)~        3. Anterior peribulbar injection of 20 mg triamcinolone~        4. Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser~        5. Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser~      For patients with two study eyes (both eyes eligible at the time of randomization), the right~     eye (stratified by prior laser) will be randomly assigned with equal probabilities to one of~     the five treatment groups listed above. If the right eye was assigned to laser only, then the~     left eye will be assigned to one of the four triamcinolone groups above with equal~     probability (stratified by prior laser). If the right eye was assigned to receive~     triamcinolone, then the left eye will receive laser only.~      Triamcinolone acetonide will be the corticosteroid utilized in this study. The triamcinolone~     acetonide preparation to be used is Kenalog. Kenalog is manufactured by Bristol Myers Squibb~     and is approved by the Food and Drug Administration for intramuscular use for a variety of~     indications. Peribulbar injections of Kenalog have been used for a wide variety of ocular~     conditions, particularly uveitis and post-cataract extraction cystoid macular edema, for many~     years.~      Two different triamcinolone regimens will be assessed in the study: 40 mg injected~     posteriorly and 20 mg injected anteriorly. There is no indication of which treatment regimen~     will be better. Although the injection behind the eye is more common than the injection near~     the front of the eye, the injection near the front of the eye has less risk of injuring the~     eye. However, it is possible that the injection near the front of the eye may increase eye~     pressure more frequently. Little is known about which of the two injections decreases macular~     edema and improves vision more often.~      Patients enrolled into the study will be followed for three years and will have study visits~     1 month, 2 months, 4 months, 8 months and annually after receiving their assigned study~     treatment. For the first 8 months of the study, patients should only be retreated with their~     randomized treatment. However, if the patient's visual acuity has decreased by 15 letters or~     more, then any treatment may be given at the investigator's discretion. After completion of~     the 8-month visit, treatment is at investigator discretion.~      The primary objective of this study is to obtain estimates of efficacy and safety outcomes~     for each of the treatment groups. These estimates will provide a basis for the sample size~     estimation and hypothesis generation in a phase III trial.~   "
243319|NCT00369473|"~     The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA~   "
243320|NCT00369460|"~     RATIONALE: Measuring changes in muscle tissue in patients with cancer may help doctors~     predict how well patients will respond to treatment, and may help the study of cancer in the~     future.~      PURPOSE: This pilot study is evaluating changes in muscle tissue in patients with pancreatic~     cancer.~   "
243371|NCT00368784|"~     This study is designed to identify the cells of the immune system that cause skin disease~     such as psoriasis and mycosis fungoides. Blood samples from many patients will be compared in~     hopes of finding common cells and molecules responsible for skin diseases. Results of this~     study will increase our knowledge about immune mediated skin disease.~   "
243321|NCT00369447|"~     This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination~     with external radiation in patients with non-small cell lung cancer. The purpose of the Phase~     I portion of the study is to evaluate the safety and feasibility of the administration of~     nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and~     to select the optimal dose for the Phase II component of the study. The primary objective for~     the Phase II portion of the study is to examine the efficacy of this combination treatment.~      The Phase I component of this study has been completed. The Phase II is now closed to~     recruitment.~   "
243322|NCT00369434|"~     The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS~     SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the~     treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of~     postmenopausal women.~   "
243323|NCT00369421|"~     Researchers intend on diagnosing and treating certain inborn errors of metabolism. By doing~     this researchers hope to expand their knowledge about these disorders and provide access to~     patients of interest for research, teaching, and clinical experience.~      Patients participating in this study will be examined and treated on an out patient basis, if~     practical. However, patients requiring specialized tests or treatments will be admitted to~     the NIH Clinical Center as necessary. Researchers will use only accepted medical procedures~     in diagnosing (medical history, physical examinations, X-ray studies, eye examinations, blood~     tests, and urine tests) and treating the patients involved in this study. Additional tests~     may be required on a case to case basis.~      Many patients seen in this study will go on to be enrolled in a specific disease-related~     research study.<TAB>...~   "
243324|NCT00369408|"~     The purpose of this study is to determine whether naltrexone, combined with brief coping~     skills therapy, is effective in the treatment of heavy drinking.~   "
243325|NCT00369395|"~     This is a Phase 2, multicenter, research study determining the effects of an investigational~     drug called volociximab in metastatic melanoma.~      The purpose of the study is to compare the clinical benefit and safety of volociximab.~     Pharmacokinetics and mechanism of action will also be evaluated.~   "
243326|NCT00369382|"~     The primary purpose of this study is to determine whether converting from calcineurin~     inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing~     calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients~     with mild to moderate renal dysfunction.~   "
243327|NCT00369356|"~     The possibility of using the new drug eluting stents (DES) technology has significantly~     changed the mid-term outcome of percutaneous coronary interventions (PCI) in terms of reduced~     recurrence of angina. The way interventionalists accomplish their work is changing~     accordingly, with a strong trend to a wider use of DES and a consequent perceived patients'~     clinical benefit.~      Evidences supporting the superiority of DES in reducing ischemic recurrence after PCI~     compared to traditional stents (BMS) are available from randomized studies. A recent~     meta-analyses underlines that:~      DES are superior to BMS in reducing clinical recurrence of ischemia, DES and BMS offer~     identical results in terms of death and infarction, Rapamycin and paclitaxel DES offer~     similar results.~      The aim of our study is to perform a multicenter, randomized study to assess the clinical~     efficacy and safety of the oral prednisone therapy after PCI as a possible systemic~     alternative to currently available BMS and DES. Furthermore, the study aims at analyzing the~     clinical outcome of the commercially available DES in the context of an independent research~     and a cost-benefit comparison with BMS and oral steroids.~   "
243328|NCT00369343|"~     Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine~     reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied~     in the development program for the treatment of major depressive disorder (MDD), for~     vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral~     diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will~     investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri-~     and postmenopausal.~   "
243329|NCT00369330|"~     To investigate if in acute symptomatic atrial fibrillation (AF) the early (>2 hrs but within~     12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer~     recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the~     beginning of the arrhythmia) within the first 3 months after cardioversion.~   "
243330|NCT00369317|"~     This phase III trial is studying how well combination chemotherapy works in treating young~     patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs~     used in chemotherapy work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more cancer cells.~   "
243331|NCT00369304|"~     This is an open-label, randomized, 2-period crossover, inpatient study to be performed in~     healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel~     cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or~     AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will~     be administered after an overnight fast of at least 10 hours.~   "
243332|NCT00369291|"~     RATIONALE: Giving CpG 7909 after an autologous stem cell transplant may make a stronger~     immune response and prevent or delay the recurrence of cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of CpG 7909 in~     treating patients who have undergone autologous stem cell transplant.~   "
243333|NCT00369278|"~     This study will assess the association of an initially intensified dosing regimen of~     enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal~     transplantation with acute rejections relative to the rapid achievement of an MPA~     (mycophenolic acid) exposure of ≥ 40 mg*h/L compared to a standard dosing regimen of EC-MPS.~     Additionally, this study will assess safety and tolerability of the intensified dosing~     regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).~   "
243334|NCT00369265|"~     The purpose of this study is to determine whether Lansoprazole 30mg taken twice daily is~     effective in the treatment of laryngitis due to gastroesophageal reflux.~   "
243335|NCT00369252|"~     This is a phase I trial of nimotuzumab that will be conducted in patients with advanced~     incurable solid tumors. This is a dose-seeking study to determine the maximum tolerated and~     recommended phase II doses of nimotuzumab that can be safely given to patients with advanced~     and/or metastatic solid tumors.~   "
243337|NCT00369226|"~     The purpose of this study is to determine if Velcade (also known as bortezomib) can help~     prevent graft versus host disease (GVHD) developing after transplantation. This is done by~     using a combination of three immune suppressive medications: Velcade, tacrolimus and~     methotrexate. Stem cell transplantation is one of the options for patients with cancer of the~     blood or blood forming organs. Recently, allogeneic stem cell transplants have been performed~     using lower doses of chemotherapy and radiotherapy: non-myeloablative or mini transplants.~     GVHD is a significant problem that may occur even after mini transplantations. Information~     from other research studies, suggests that Velcade may help to reduce the risk of developing~     GVHD when given early after transplantation.~   "
243338|NCT00369213|"~     This RCT compares the clinical and non clinical condom failure rate among condom using~     heterosexual couples with and without externally applied additional spermicidal lubricant.~     The hypothesis is that breakage and slippage rates will be reduced.~   "
243339|NCT00369200|"~     This phase I trial is studying the side effects and best dose of AFP464 in treating patients~     with advanced solid tumors. Drugs used in chemotherapy, such as AFP464, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~   "
243340|NCT00369187|"~     This Phase IV, dose escalation, within-patient controlled study of pharmacokinetics (PK),~     safety and tolerability compares a single dose administration of a large protein molecule~     without recombinant human hyaluronidase (rHuPH20) to a single dose administration of the~     large molecule with escalating doses of rHuPH20. The study hypothesizes that an optimal dose~     of rHuPH20 will increase the bioavailability of large molecule drug administration.~   "
243341|NCT00369174|"~     This phase II trial is studying how well rosiglitazone works in preventing oral cancer in~     patients with oral leukoplakia. Chemoprevention is the use of certain drugs to keep cancer~     from forming, growing, or coming back. The use of rosiglitazone may keep cancer from forming~     in patients with oral leukoplakia~   "
243342|NCT00369161|"~     This study is designed to evaluate whether tacrolimus dose reduction in de novo renal~     recipients receiving everolimus can preserve renal function while maintaining efficacy.~   "
243343|NCT00369148|"~     Combination therapy of glinides with premixed insulin provides better glycemic control than~     premixed insulin alone.~   "
243344|NCT00369135|"~     Sickness absenteeism caused by MSDs is a persistent and expensive health challenge in all~     industrial countries including Switzerland. Despite much progress as to the cause and~     prevention of MSDs, they continue to be some of the most prevalent and challenging health~     problems with respect to the work-place and to socio-economic burden.~      To improve the situation, several recent reviews recommended interventions based on the~     bio-psycho-social model. Work-hardening and industrial rehabilitation programs focused more~     on the in balance between physical and mental demands of work on one side and capacities of~     the individual on the other side. Therefore we propose to merge the two models into one. The~     result is an interdisciplinary intervention strategy witch includes work hardening, medical~     trainings, a cognitive behavioural approach and work place intervention.~   "
243345|NCT00369122|"~     This phase II trial is studying how well giving bevacizumab together with radiation therapy~     and cisplatin works in treating patients with previously untreated locally advanced cervical~     cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of~     cervical cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving bevacizumab together with radiation therapy and cisplatin may kill more~     tumor cells.~   "
243346|NCT00369109|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This laboratory study is collecting skin biopsy specimens from patients receiving~     irinotecan or gemcitabine for advanced solid tumors and using them to study change in DNA due~     to this treatment.~   "
243347|NCT00369096|"~     The purpose of this study is to evaluate whether addition of bemiparin, once daily in~     icodextrin solution for peritoneal dialysis for 16 weeks, increases the peritoneal capacity~     for ultrafiltration and/or reduces creatinine transport in peritoneal dialysis patients~     presenting functional disorders related to ultrafiltration deficit and/or high transport.~   "
243348|NCT00369083|"~     Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with~     inpatient care in selected elderly patients with acute exacerbation of chronic obstructive~     pulmonary disease (COPD).~   "
243349|NCT00369070|"~     The purpose of this study is to estimate the difference in objective response rates between~     each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus~     bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC.~   "
243350|NCT00369057|"~     Our goal is to study the relationship between intraocular pressure during robotic~     prostatectomy surgery and visual deficiencies/vision loss after surgery. We believe the risk~     of vision loss from this surgery to be due to positioning during the operation, as well as~     abdominal carbon dioxide insufflation. As robotic procedures are gaining in popularity, we~     should determine whether they are subjecting this patient population, and perhaps more likely~     the patient with a preoperative diagnosis of glaucoma, to an increased likelihood of~     postoperative visual disturbance.If our hypothesis that intraocular pressure is increased in~     these patients is confirmed, future studies will assess therapeutic modalities to maintain~     the IOP near baseline.~   "
243351|NCT00369044|"~     We designed this, randomized, double-blind, placebo-controlled trial to determine the~     clinical efficacy of chronic administration of prednisone on renal function and clinical~     status when added to standard care.~   "
243352|NCT00369031|"~     The purpose of this study is to determine whether an HIV vaccine given as three nasal~     immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two~     intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes~     untoward adverse reactions when administered to healthy adult volunteers. An initial~     evaluation of immune responses to the vaccine will also be undertaken.~   "
243355|NCT00368992|"~     Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop~     the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving cetuximab together with~     paclitaxel, carboplatin, and bevacizumab may kill more tumor cells. This phase II trial is~     studying how well giving cetuximab together with paclitaxel, carboplatin, and bevacizumab~     works in treating patients with advanced non-small cell lung cancer~   "
243356|NCT00368979|"~     This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52~     weeks to Benign Prostatic Hyperplasia (BPH) patients.~   "
243357|NCT00368966|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given~     concomitantly with routine pediatric vaccinations in Spain.~   "
243358|NCT00368953|"~     Revascularisation procedures such as percutaneous coronary intervention are associated with~     overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is~     associated with higher restenosis rates compared to non-diabetic individuals.~      There is only limited data available on the efficacy and safety of the novel Yukon Choice~     drug-eluting stent system specifically in patients with diabetes mellitus. The trial will~     determine the efficacy and safety of the novel Yukon Choice stent system compared to the well~     established Taxus Liberté stent system. The primary endpoint will be in-stent late lumen~     loss at 9 months as determined by invasive angiography.~   "
243359|NCT00368940|"~     This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) vs. Supportive~     Therapy for Cognitively Impaired (ST-CI) older adults in reducing depression and disability~     in treating depressed, cognitively impaired older adults.~   "
243360|NCT00368927|"~     This randomized phase II trial is studying sulindac to see how well it works compared to a~     placebo in preventing lung cancer in current or former smokers with bronchial dysplasia.~     Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming~     back. The use of sulindac may prevent lung cancer from forming in patients with bronchial~     dysplasia. It is not yet known whether sulindac is more effective than a placebo in~     preventing lung cancer in patients with bronchial dysplasia.~   "
243361|NCT00368914|"~     RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of sirolimus in~     treating patients with metastatic or unresectable solid tumors.~   "
243362|NCT00368901|"~     To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant~     human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.~   "
243363|NCT00368888|"~     To determine whether a new urine collection bag for infants produces a reliable urine sample~     for culturing in respect of contamination rate with skin bacteria.~   "
243364|NCT00368875|"~     This phase I/II trial is studying the side effects and best dose of vorinostat when given~     together with paclitaxel and bevacizumab and to see how well they work in treating patients~     with metastatic breast cancer and/or breast cancer that has recurred in the chest wall and~     cannot be removed by surgery. Vorinostat may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some find tumor cells and kill them or carry tumor-killing~     substances to them. Others interfere with the ability of tumor cells to grow and spread.~     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Giving vorinostat together with paclitaxel and bevacizumab may kill more tumor cells.~   "
243365|NCT00368862|"~     The aim of the present study was to examine the influence of memantine, a noncompetitive NMDA~     receptor blocker, in depression co-morbid with long term alcohol heavy use comparing to~     SSRI-inhibitor, escitalopram. Second goal is to compare their influence to cognitive tasks~     and the third goal is to follow up alcohol-use with these two medicines.~   "
243366|NCT00368849|"~     The purpose of this research study is to evaluate the effect of atomoxetine (also known as~     Strattera) compared to placebo (inactive substance) on daily activities such as attention and~     focus, thinking ability and muscle movements in subjects with early Huntington Disease (HD)~     and attention deficit disorder (ADD).~   "
243367|NCT00368836|"~     A pulmonary embolism (PE) is a blockage in one of the arteries of the lungs, and is usually~     caused by a traveling blood clot. The D-dimer blood test is currently used to diagnose PEs,~     but it is not always accurate for individuals who have recently undergone surgery or who have~     inflammatory-provoking diseases. The purpose of this study is to evaluate the effectiveness~     of the Carboximeter, a new PE diagnostic device that measures carbon dioxide (CO2) and oxygen~     (O2) output, in individuals at risk for developing PEs.~   "
243368|NCT00368823|"~     Does presentation of clinical evidence for decision making at point-of-care improve~     prescribing patterns in ambulatory pediatrics?~   "
243369|NCT00368810|"~     This study will examine whether resistance to severe malaria is associated with weakening of~     a specific immune response (TLR-mediated pro-inflammatory cytokine response). Some children~     with mild malaria go on to develop severe disease, while others do not. The study will~     analyze certain substances in the blood to try to determine what factors may protect against~     severe malaria.~      Healthy children and children 3 - 10 years of age with severe malaria who are being treated~     at l'H pital Gabriel Toure in Mamako, Mali, West Africa, may be eligible for this study.~     Participants have a mall sample of blood drawn from a vein and from two finger pricks.~   "
243370|NCT00368797|"~     This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR~     plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients~     with severe Peripheral Arterial Occlusive Disease, Fontaine's stage IV. The efficacy was~     assessed by the complete healing of at least one ulcer in the treated limb, 25 week~     post-baseline and secondary by the rate of amputation and death.~   "
243372|NCT00368771|"~     The purpose of this study is to assess the effect of participation in one of the following~     interventions: (1) IBS Stress Management; (2) IBS Symptom Management; or (3) IBS Educational~     Training on improving IBS associated symptoms. It is anticipated that this research will~     provide information on the usefulness of psychological approaches in treating IBS and will~     help scientists better understand the disorder.~   "
243373|NCT00368758|"~     The purpose of the study is to establish an in-vitro method to evaluate the effect of~     probiotics on gas production in feces (hydrogen and methane)~   "
243374|NCT00368745|"~     GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet~     eligibility criteria will be randomized to receive pregabalin vs matching placebo while~     simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment~     of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and~     benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam,~     will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use).~     The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to~     discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated~     groups. Hypothesis is that a greater proportion of subjects will be successful in~     discontinuing and remaining free from benzodiazepines who were treated with pregabalin as~     compared to subjects treated with placebo.~   "
243375|NCT00368732|"~     Each year in the United States, thousands of babies are born with heart defects. Women who~     take folic acid during pregnancy have a lower risk of giving birth to infants with heart~     defects, but the reason for this remains unknown. This study will examine the relationship~     between genes, nutrition, and the occurrence of heart defects in infants.~   "
243376|NCT00368719|"~     To assess the long-term safety of tacrolimus ointment~   "
243377|NCT00368706|"~     To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects~     with overactive bladder compared to tolterodine wmg, bid~   "
243378|NCT00368693|"~     The purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR~     combined with standard treatment. We hypothesize the treatment will provide beneficial~     results for diabetic patients suffering foot ulcers.~   "
243379|NCT00368680|"~     The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup~     of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this~     group, without affecting mortality.~   "
243380|NCT00368667|"~     The purpose of this study is to investigate the potential biological predispositions that~     contribute to the difficulty patients with anorexia nervosa have in maintaining normal~     weight.~   "
243381|NCT00368654|"~     To evaluate whether a short-term course of methotrexate in patients treated with efalizumab~     (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the~     efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment~     with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term~     combination therapy of Raptiva and methotrexate.~   "
243382|NCT00368641|"~     The objective of the study is to determine if the addition of peritoneal ultrafiltration to~     standard therapy in treatment-resistant severe heart failure patients will improve fluid~     balance and functional capacity such that they will spend less time in the hospital and have~     an improved ambulatory quality of life in comparison to patients who remain on standard~     therapy alone.~   "
243383|NCT00368628|"~     New stroke therapies are needed. This study seeks to provide the preliminary data needed to~     plan a future study that will evaluate the efficacy of using continuous positive airway~     pressure (CPAP) to treat stroke patients who have sleep apnea. Our goal is to use this~     therapy to reduce stroke symptom severity.~   "
243384|NCT00368615|"~     The aim of this study is to study T-cells. Blood will be collected and the samples will be~     used to generate T cell clones. Two separate blood draws will be required at the maximum.~   "
243385|NCT00368602|"~     The purpose of this study is to evaluate the efficacy and safety of treatment of chronic~     cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®).~   "
243386|NCT00368589|"~     A new way of scanning narrowing in the arteries (main blood vessels) caused by fatty deposits~     known as plaques has been developed. Heart attacks and strokes occur when plaques become~     inflamed, depending on the artery affected. Currently used clinical tests can only tell us~     how much the vessel is blocked by the plaque and not how inflamed (i.e. dangerous) it is.~     This new method of scanning using magnetic resonance imaging (MRI) and a special agent called~     Sinerim can identify inflamed plaques. This study will evaluate patients with plaques in~     their arteries in their neck at risk of strokes to see whether treatment with a~     cholesterol-lowering drug called atorvastatin can reduce the amount of inflammation within~     the artery wall within the first three months of treatment. If this effect can be measured~     using MRI scanning with the use of Sinerim then the results of this study will provide~     additional clinical validation of the use of MRI scanning combined with agents such as~     Sinerem®.~   "
243387|NCT00368576|"~     The purpose of this study is to compare the effects of SB-480848 with placebo in subjects~     with asthma.~   "
243388|NCT00368563|"~     To evaluate the ability of 2 Helioblock SX Cream formulations to moisturize skin using~     capacitance and transepidermal water loss methodology~   "
243389|NCT00368550|"~     The purpose of this study is to determine whether Sertraline, compared to placebo, is~     effective in the treatment of alcohol dependence as a function of the subtype of alcoholic~     patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or~     an inactive placebo for a 14-week treatment period.~   "
243390|NCT00368537|"~     The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline~     with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of~     a complicated skin and/or skin structure infection (cSSSI).~   "
243401|NCT00368394|"~     To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after~     single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic~     clamp technique using the Biostator (TM).~   "
243402|NCT00368381|"~     The purpose of this study is to determine if the combination of hydrocortisone plus~     fludrocortisone is more efficacious than hydrocortisone alone in treating adrenal~     insufficiency in severe sepsis.~   "
243391|NCT00368524|"~     This randomized controlled trial examined whether an abbreviated treatment using abstinence~     contingency management for housing and work/training (CM, n=103) with cocaine dependent,~     non-psychotic, dually diagnosed homeless persons, would show non-inferior outcomes compared~     to the full treatment (CM+, n=103). It was hypothesized that CM+ would show superior~     abstinence and retention outcomes, but that CM, with components derived from previously~     effective behavioral day treatment, would obtain non-inferior outcomes, defined as 75% or~     more of those observed for the full treatment (CM+) during active treatment months 1-6. The~     CM+ included all CM components but added behavioral day treatment that included voucher~     reinforcement of $7.50-15.00, for objective weekly therapeutic goal attainment in five~     domains of functioning: drug dependence, homelessness, unemployment, non-drug related~     recreational activities, and behavioral, health, or mental health problems. Abstinence was~     assessed by observed urine specimen collection and weekly testing weeks 1-52, and randomly,~     bi-monthly for months 13-18. Abstinence, homelessness, employment and other outcomes were~     also assessed at baseline, 2, 6, 12, and 18 months.~   "
243392|NCT00368511|"~     We propose to obtain computerized dynamic posturography scores on patients in a~     (psycho)geriatric nursing home utilizing the CAPS system from Vestibular Technology. This~     instrument has been validated to measure human stability and is associated with a Fall~     Probability percentage. Subjects will be asked to stand on a platform with eyes open and~     closed for approximately 30 seconds. The data obtained will be utilized as a base for change~     which can be compared to an outcome of music listening and fall prevention. Previous~     investigations have demonstrated a decrease in fall rates associated with music listening. We~     would like to measure the changes in human stability associated with a potential decrease in~     fall rates. We would also like to use the history of falls of the tested individuals if~     available. In case fall statistics are available we respectfully request access to all falls~     data available from the involved geriatric nursing home . The falls data will be kept~     confidential and only used as a control statistic in our evaluation of fall rates after~     implementation of our applications. The music used will include Nolwenn Leroy, Mozart and~     other Dutch and French Singers.~   "
243393|NCT00368498|"~     The purpose of this study is to determine whether the standard dosage of teicoplanin is~     adequate to produce timely the trough level > 10 mg/L, which is considered to be effective in~     the treatment of methicillin-resistant Staphyllococcus aureus (MRSA) bacteremia.~   "
243394|NCT00368485|"~     The present study will use a new type of respirator in premature babies who need help with~     their breathing. This new respirator uses signals from the baby's diaphragm - the most~     important breathing muscle - to control the timing and the amount of air that the baby needs.~     The goal of the study is to demonstrate that this new respirator can synchronize delivery of~     air to the baby's efforts, and that synchrony is maintained regardless of whether the baby is~     breathing with a tube or a mask.~   "
243395|NCT00368472|"~     The purpose of this study is to determine the safety of perampanel given as adjunctive,~     long-term treatment in patients with refractory partial onset seizures.~   "
243396|NCT00368459|"~     This is a multisite pilot randomized trial of raloxifene or placebo for the treatment of~     women with Alzheimer's disease.~   "
243397|NCT00368446|"~     Healthy volunteers and patients with diseases that involve problems clearing mucus from the~     lungs will be examined and tested to better understand the reasons for recurring lung~     infections in these patients and to try to develop better ways to diagnose and treat them.~     The study will also try to identify the genes responsible for these diseases.~      Healthy volunteers 18 years of age and older and patients 2 years of age or older with~     suspected primary ciliary dyskinesia (PCD), variant cystic fibrosis (CF) or~     pseudohypoaldosteronism (PHA) may be eligible for this study. Patients enrolled in the~     Natural History Study of Nontuberculous Mycobacteria at NIH or other NIH natural history~     protocols may also be enrolled. Participants undergo the following tests and procedures~     during a 1-day visit at the NIH Clinical Center, as follows:~      All patients and normal volunteers have the following procedures:~        -  Physical examination and review of medical and genetic history and family genetic~          history.~        -  Lung function test and measurement of oxygen saturation level.~        -  Nitric oxide measurement to measure the amount of nitric oxide production in the nose: A~          small tube is placed in the nose while the subject breathes through the mouth into a~          cardboard tube.~      All patients have the following additional procedures:~        -  Blood tests for liver and kidney function, blood count, immunoglobulins and pregnancy~          test (where appropriate).~        -  Blood test or buccal scrape (brushing the inside of the cheek) to obtain DNA to look for~          gene mutations that cause PCD, CF or PHA.~        -  Scrape biopsy of cell lining the inside of the nose: A small toothpick-sized plastic~          stick with a tiny cup on the end is used to get nasal lining cells to look at the cilia~          (hair-like structures that move mucus).~        -  Semen analysis (in some men) to test sperm tail function or structure.~      Patients suspected of having a variant of CF or PHA, including nontuberculous mycobacterial~     lung disease, have the following additional procedures:~        -  Sweat chloride test: A medicine is placed on the arm to produce sweat; then, a very low~          level of electric current is applied for 5 to 12 minutes. Sweat is collected in a~          plastic tube and tested for salt content.~        -  Blood draw for CF genetic testing, if necessary, and to measure levels of the enzyme~          trypsin.~        -  Saliva collection to measure sodium and chloride content.~        -  Nasal potential difference to measure the electrical activity of the cells lining the~          inside of the nose: A soft plastic tube filled with a salt solution is passed into the~          nasal passage and a sterile needle is placed under the skin of the arm. This test~          provides information about how the lining of the nose is able to get used to changes in~          temperature and humidity. (Normal volunteers also have this test.)~   "
243398|NCT00368433|"~     This study will investigate how the sensitivity to touch and smell in patients with Tourette~     syndrome (TS) may differ from that of people without TS. TS is a neurological disorder that~     causes people to have uncontrolled movements called tics. A tic can also be vocal, like a~     cough or bark or string of bad words. The tic is preceded by a premonitory urge that may~     feel like an itch or pressure that builds until the tic occurs. To some patients, the tic~     feels like a response to an involuntary sensation. In patients with TS, sensory information~     may be processed differently than it is in people without TS. This study will compare how~     strong a sensation feels in TS patients and healthy volunteers. It will also look for muscle~     activity that may be responsible for the feelings in the area of the tic.~      Healthy normal volunteers and people with Tourette syndrome, 18 to 65 years of age, may be~     eligible for this study. Candidates are screened with a medical history and brief physical~     and neurological examinations. TS patients complete a questionnaire about their tics and are~     interviewed by a psychiatrist. Women who can become pregnant will have a urine pregnancy test~     prior to any other procedures. Pregnant women cannot participate.~      All participants undergo sensory testing for touch and smell. They are asked to distinguish~     between a scented and scentless object and rate how strongly they feel the scent. Later, with~     their eyes closed, they are asked to tell whether or not they are being touched, and to rate~     how intensely they felt the touch.~      In addition to the sensory testing, TS patients, but not normal volunteers, undergo~     electromyography (EMG), a test that measures the electrical activity of muscles. For surface~     EMG, small metal disks called electrodes are filled with a conductive gel and taped to the~     skin. Wire EMG involves inserting a wire into a muscle using a needle. All patients have~     surface EMG and those who consent to it will also have wire EMG.~   "
243399|NCT00368420|"~     The purpose of this study is to validate a score developed by the AGO-OVAR for complete~     resection of the tumor~   "
243400|NCT00368407|"~     To determine the optimal treatment frequency of 308-nm excimer laser for vitiligo and~     identify the key clinical variable(s) associated with the treatment efficiency under the~     optimal treatment frequency.~      Prospective, randomized, comparative study among groups of vitiligo patients treated with~     308-nm excimer laser, with the limitation of no follow-up.~   "
243403|NCT00368368|"~     This study will investigate the effect of renal impairment on the~     pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and~     will evaluate the effect of renal function on the safety of the drug. Patients will be~     assigned to treatment groups according to their renal function (normal, moderate renal~     impairment, or severe renal impairment). After a 1 week washout period from current oral~     anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator~     (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on~     study treatment is <3 months, and the target sample size is <100 individuals.~   "
243404|NCT00368355|"~     Subjects are being asked to participate in this study because treatment of their disease~     requires them to receive a stem cell transplant. Stem cells or mother cells are the source~     of normal blood cells and lead to recovery of blood counts after bone marrow transplantation.~     Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother)~     and the subject's disease is considered rapidly progressive and does not permit enough time~     to identify another donor (like someone from a registry list that is not their relative). We~     have, however, identified a close relative of the subject's whose stem cells are not a~     perfect match, but can be used. However, with this type of donor, there is typically an~     increased risk of developing graft-versus-host disease (GVHD), a high rate of transplant~     failure, and a longer delay in the recovery of the immune system.~      GVHD is a serious and sometimes fatal side effect of stem cell transplant. GVHD occurs when~     the new donor cells (graft) recognizes that the body tissues of the patient (host) are~     different from those of the donor. When this happens, cells in the graft may attack the host~     organs, primarily the skin, liver, and intestines. The number of occurrences and harshness of~     severe GVHD depends on several factors, including the degree of genetic differences between~     the donor and recipient, the intensity of the pre-treatment conditioning regimen, the~     quantity of transplanted cells, and the recipient's age. In recipients of mismatched family~     member or matched unrelated donor stem cell transplants, there is a greater risk of GVHD so~     that 70-90% of recipients of unchanged marrow will develop severe GVHD which could include~     symptoms such as marked diarrhea, liver failure, or even death.~      In an effort to lower the occurrences and severity of graft-versus-host disease in patients~     and to lower the rate of transplant failure, we would like to specially treat the donor's~     blood cells to remove cells that are most likely to attack the patient's tissues. This will~     occur in combination with intense conditioning treatment that the patient will receive before~     the transplant.~   "
243405|NCT00368342|"~     Chronic Bronchiolitis or Resistant Asthma? Testing a way to diagnosis and treatment~   "
243406|NCT00368329|"~     To study the safety and feasibility of stereotactic radiation dose escalation following~     neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating~     the acute and late toxicity of treatment.~   "
243407|NCT00368316|"~     Shigellosis remains a serious and frequent disease throughout the world. Development of~     vaccines has been difficult because shigellae are habitants of and pathogens for humans only~     and there is no consensus about the mechanism(s) of immunity to this pathogen.~      Incomplete, but compelling evidence, indicates that a critical level of serum IgG anti-LPS~     confers immunity to shigellosis. Important data come from our clinical trial in the Israel~     Defense Forces (IDF) recruits. A randomized, double-blind, vaccine-controlled study showed~     that the S. sonnei-rEPA elicited 74% protection against shigellosis occurring about 3 months~     after vaccination (p=0.001). This vaccine conferred 43% (p=0.04) protection in one company~     during an outbreak up to 14 days following vaccination suggesting that our Shigella~     conjugates might be of value in epidemics. The efficacy of S. sonnei-rEPA was correlated with~     the level of vaccine-induced IgG antibodies.~      The highest incidence, morbidity, and mortality of shigellosis is in young children. But~     serum antibody responsiveness to polysaccharide-based vaccines is age-dependent and infants~     and young children respond poorly or not at all to both disease and vaccination. The safety~     and immunogenicity of these Shigella conjugates in 4 to 6 years-old children in Israel was~     demonstrated. But although the fold rise in anti-LPS was similar in the children, the level~     of anti-LPS elicited by the conjugates was lower than in adults. We improved the~     immunogenicity of Shigella conjugates as shown in mice and then in adult humans. Now we apply~     to evaluate the safety, immunogenicity and efficacy of these improved conjugates in 1 to 4~     years-old children in Israel.~      In Israel, shigellosis is common especially in children. S. sonnei (Group D) comprise about~     60% of the isolates followed by S. flexneri (Group B): Shigella dysenteriae type 1 (Group A)~     is not found. We propose to administer 2 injections of either S. sonnei-CRM9 or S. flexneri~     type 2a-rEPAsucc 6 weeks apart in a random double-blind fashion to about 6,000 1 to 4~     year-olds. Active surveillance of the vaccinees for enteric infections will be maintained for~     at least 2 years to evaluate the effect of vaccination.~   "
243408|NCT00368303|"~     The study is to investigate the non-inferior efficacy of Paroxetine Controlled Release to~     Paroxetine Immediate Release, as well as the drug tolerability profile when treated on~     patients with Major Depression.~   "
243409|NCT00368290|"~     The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces~     high risk behavior in cocaine dependent subjects.~   "
243410|NCT00368277|"~     Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to~     ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.~   "
243411|NCT00368264|"~     Background:~      Standard therapy is ill-defined for patients with systemic lupus erythematosus (SLE)~     suffering from the membraneous form of Lupus nephritis (WHO class V). Therapeutic options~     used at present include azathioprine.~      In a small, open label safety study, patients with lupus nephritis, including patients with~     membraneous lupus nephritis, have experienced a long-lasting therapeutic response, with~     sustained reduction in proteinuria, following a 10 weeks course of 4 infusions of infliximab~     in combination with azathioprine. This short course appeared safe with regard to SLE~     activity, despite increases in autoantibody levels.~      Study hypothesis:~        1. The combination of four infusions of infliximab (5 mg/kg of body weight)administered at~          weeks 0, 2,6, and 10, with azathioprine will be faster than azathioprine alone in~          reducing proteinuria to less than 1.5 g/day in patients with active lupus nephritis WHO~          class V (proteinuria > 3g/day).~        2. This combination therapy will show a tolerable safety profile with regard to SLE~          activity and infections.~   "
243412|NCT00368251|"~     The study will compare the efficacy and safety of Brivaracetam with placebo in patients with~     Unverricht- Lundborg Disease (ULD).~   "
243413|NCT00368238|"~     The purpose of this study is to see if a naturally-occurring hormone called erythropoietin~     changes the action of platelets in the blood. Erythropoietin is made by the kidneys to~     stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood~     that help clot blood in case of injury. Platelets also sometimes form blood clots in blood~     vessels that may cause heart attacks. This study is trying to determine whether~     erythropoietin increases the clotting action of platelets. Information on erythropoietin in~     healthy subjects may eventually help in the treatment of patients with heart attacks.~   "
243450|NCT00367757|"~     Patient Population: Patients with AF that is symptomatic and refractory to at least one~     antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6~     months, two episodes >6 hours within 1 year) or persistent (sustained episode <6 months~     terminated by cardioversion or drug).~      Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based~     technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation~   "
243451|NCT00367744|"~     The purpose of this study is to examine the effect of rosiglitazone on limb fat and~     mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that~     does not contain stavudine (d4T) or zidovudine (AZT).~   "
243414|NCT00368225|"~     This study will explore why severe scarring of the liver (cirrhosis) develops so rapidly in~     hepatitis C-infected patients who have had a liver transplant and possibly in kidney~     transplant patients as well. The hepatitis C virus (HCV) can cause cirrhosis in about 20~     percent of infected persons. Generally, it takes 20 years or more for cirrhosis to develop.~     After liver transplantation, however, patients may develop cirrhosis in as little as 5 years.~     Cirrhosis does not develop as rapidly in kidney transplant patients, but it may develop~     faster than in people who do not undergo transplantation. The study will look at the possible~     role of immune-suppressing medications given to liver and kidney transplant patients in~     increasing the severity of hepatitis C infection and in speeding the cirrhotic process.~      Patients 18 years of age and older with chronic HCV infection who require a liver transplant~     for end-stage liver disease or a kidney transplant for kidney failure may be eligible for~     this study. Liver transplant patients are recruited from the Inova Fairfax Liver Transplant~     Center in Fairfax, Virginia, and from the Georgetown University Medical Center Liver~     Transplant Institute in Washington, D.C. Kidney transplant patients are recruited from the~     Transplantation Branch of the National Institute of Diabetes and Digestive and Kidney~     Diseases.~      Participants undergo the following procedures:~        -  Regular care: As part of their regular transplant-related treatment, patients have a~          medical history, physical examinations and blood draws before their transplant and on~          regularly scheduled visits after the transplant.~        -  Blood draws for research: Special blood tests are done to measure the immune response to~          HCV. They measure the amount of HCV in the blood, the number of HCV strains present and~          how they change over time and the HCV antibodies in the blood.~        -  Liver biopsies: This procedure is done at 3 months, 1 year, 3 years and 5 years after~          the transplant to determine the extent of scarring of the liver and to study the immune~          responses within the liver, the proportion of liver cells infected with HCV and the~          presence of scar-producing cells. The biopsy is done during a 1- to 2-day inpatient~          hospital stay. The patients are given a sedative medication through a vein before the~          procedure. The skin over the biopsy site is numbed and the biopsy needle is passed~          rapidly into and out of the liver to collect a small sample of liver tissue for study.~        -  Apheresis: This procedure is done to collect a large number of white blood cells needed~          to test the immune response to the HCV. On the day before each liver biopsy, blood is~          drawn through a needle from a vein in one arm and run through a machine that separates~          and collects the white cells. The red cells and plasma are returned to the patient's~          body through the same needle or a second needle in the other arm.~   "
243415|NCT00368212|"~     This study will evaluate the effectiveness of an integrated three-part treatment program in~     improving the quality of care and treatment outcomes of people with hypochondriasis in~     primary care settings.~   "
243416|NCT00368199|"~     The purpose of the study is to determine the sensitivity and specificity of transcranial~     duplex scanning (TCD) and single photon emission computer tomography (SPECT) in patients~     suspected of having Idiopathic Parkinson Disease (PD) or Atypical Parkinson Syndromes (APS)~     with as golden standard the clinical diagnosis after 2-year follow-up.~   "
243417|NCT00368186|"~     The primary objectives of this study were to assess the immunogenicity and the tolerance of~     the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age)~     with sickle cell disease when administred at 2,3, and 4 months of age.~   "
243418|NCT00368173|"~     STUDY OBJECTIVE~      To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of~     rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with~     GHIS.~      STUDY DESIGN~      This study is an open-label, multi-center clinical trial to evaluate the safety and~     effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily~     for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS)~     such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional~     safety and long-term efficacy data will be assessed in a second 12 month treatment period.~   "
243419|NCT00368160|"~     Male and female healthy volunteers. Patients must also possess a full current driving license~     (for at least one year), and be a regular car driver.~   "
243420|NCT00368147|"~     The purpose of this study is to determine if the creation of a fistula or a graft plays a~     role in the development of heart disease for patients undergoing hemodialysis~   "
243421|NCT00368134|"~     This study is designed to evaluate the efficacy, safety and tolerability of vildagliptin~     compared to voglibose in patients with type 2 diabetes. Please note this study is not being~     conducted in the United States.~   "
243422|NCT00368121|"~     EMMA-1 is an open-label, non-randomized, two-stage phase II study. Patients with refractory~     multiple myeloma stage II or III or relapsed disease after at least one line of treatment~     will receive Cetuximab+/-Dexamethasone.~      The planed treatment duration per patient is 16 weeks. Patients achieving a response or~     stable disease after 16 weeks of treatment may continue study medication for 6 more months~     (patients receiving Cetuximab alone) or for 3 more months (patients receiving Cetuximab plus~     Dexamethasone). Responding patients who relapse during follow-up period of two years may~     receive a second treatment with Cetuximab following initial study guidelines~   "
243423|NCT00368108|"~     This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of~     E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.~   "
243424|NCT00368095|"~     Metabolic Syndrome (hypertension, diabetes mellitus, obesity, cerebrovascular-cardiovascular~     disease) In Community Survey was performed in central Bangkok.~      Prospective Cohort and intensive educated intervention (health promotion program in specific~     high risk groups) were performed. The aim of the study is to identify high risk patients who~     can develop serious complications from metabolic syndrome. An analysis of health outcomes in~     multiple dimensions will be performed.~   "
243425|NCT00368082|"~     Patients have a type of lymph gland cancer called HD, NHL or lymphoepithelioma (these 3~     diseases will be referred to as Lymphoma). The lymphoma has come back or has not gone away~     after treatment (including the best treatment known for these cancers). This is a research~     study using special immune system cells called TGFb-resistant LMP-specific cytotoxic T~     lymphocytes (DNR-CTL), a new experimental therapy.~      Some patients with Lymphoma show signs of infection with the virus that causes infectious~     mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis of the~     Lymphoma. EBV is found in the cancer cells of up to 1/2 the patients with Lymphoma,~     suggesting it may play a role in causing Lymphoma. The cancer cells infected by EBV are able~     to hide from the body's immune system and escape being killed by releasing a substance called~     Transforming Growth Factor-beta (TGFb). The investigators want to see if special white blood~     cells (called T cells) that have been given a gene that they hope will let them survive~     against TGFb and that have been trained to kill EBV infected cells can also survive in the~     blood and kill the tumor.~      Investigators have used this sort of therapy with specially trained T cells to treat a~     different type of cancer that occurs after bone marrow and solid organ transplant called post~     transplant lymphoma. In this type of cancer they were able to successfully prevent and treat~     post transplant lymphoma. However when they used a similar approach in HD some patients had a~     partial response to this therapy, but no patients had a complete response. In a follow-up~     study they tried to find out if they could improve this treatment by growing T cells that~     recognize 2 of the proteins expressed on Lymphoma cells called LMP-1 and LMP2a. These special~     T cells were called LMP-specific cytotoxic T-lymphocytes (CTLs). Although some patients had~     tumor responses, CTL therapy alone did not cure those who had a lot of disease. Investigators~     think that a reason for this is that the tumor cells are releasing TGFb (a substance that~     inhibits the growth and function of CTLs). For this reason, they want to find out if they can~     make the CTL resistant to TGFb by putting in a new gene called TGFb resistance gene.~     Investigators hope but don't know that this will improve this treatment for relapsed~     lymphoma. These TGFb-resistant LMP-specific CTLs are an investigational product not approved~     by FDA.~      The purpose of this study is to find the largest safe dose of TGFb resistant LMP-specific~     CTLs, to learn what the side effects are and to see whether this therapy might help patients~     with HD, NHL and lymphoepithelioma.~   "
243426|NCT00368069|"~     This is a safety and efficacy study of Keppra® extended release formulation - XR in patients~     with epilepsy.~   "
243427|NCT00368056|"~     To assess next day driving ability and psychomotor/memory function following a single night~     time dose of eszopiclone in insomnia patients.~   "
243428|NCT00368043|"~     The deleterious effects of institutionalized care on the health and growth and development of~     children have been described. Early studies have shown that the effects of institutionalized~     care on a child's growth and development may not be fully reversible. The exact mechanism~     through which these early stresses affect bio-behavioral outcomes has yet to be determined. A~     likely mechanism in which environmental influences could regulate both biological and~     psychosocial development may be through the hypothalamic pituitary adrenal axis (HPA). Recent~     advances in the area of brain research have enriched our understanding of the importance of~     early life experiences on physical, cognitive, developmental, mental and behavioral health~     outcomes. Children adopted from orphanages in countries as diverse as the former Soviet Union~     and Guatemala provide an opportunity to learn more about the effect of deprivation on~     neuro-endocrine function, physical growth, and developmental outcomes, including cognitive,~     and behavioral measures.~      This protocol proposes to study the changes of the HPA axis of the post-institutionalized~     adoptive child, ages 10 months to 4 years, which may help elucidate the etiology of the~     complex findings in this population. We will recruit 60 adopted children who experienced~     institutionalized care and were recently adopted by a US family and 60 controls. Our primary~     hypothesis is that a number of adopted children will have biochemical evidence of~     stress-induced activation of the HPA axis and sympathetic adrenal medullary system. HPA~     dysfunction will be evident by abnormal diurnal salivary cortisol levels, increased cortisol~     and/or catecholamine excretion in 24 hours urine measurements, and dysregulation of autonomic~     nervous system activity We also hypothesize that many of these responses will not normalize~     with time and that there will be a correlation between these responses and growth and~     behavioral disorders. In addition, we will examine nutritional intake and sleep patterns to~     determine their effect on growth and developmental outcome....~   "
243429|NCT00368030|"~     The purpose of this study is to evaluate subjective sleep efficacy in subjects with insomnia~     related to major depressive disorder.~   "
243430|NCT00368017|"~     The substantially increased cardiovascular morbidity and mortality rates in chronic kidney~     disease (CKD) patients cannot be sufficiently explained by traditional coronary risk factors.~     It is apparent that inflammation of the vessel wall plays an essential role in the~     pathophysiology of atherosclerosis, and the strong association between elevated inflammatory~     biomarkers and cardiovascular death further supports this mechanism. Approximately 50% of the~     mortality in this population of patients is attributable to cardiovascular disease. Insulin~     resistance is also a common problem in uremic patients. It has been shown that insulin~     resistance may contribute to atherosclerotic cardiovascular disease. An intriguing~     observation in CKD patients with advanced uremia is that the metabolic profile of these~     patients is characterized by persistent low-grade inflammation, a state of insulin~     resistance, and significantly increased prevalence of atherosclerosis. It is possible that~     these metabolic derangements can be the inciting factors for development and progression of~     uremic atherosclerosis. Peroxisome proliferator-activated receptor gamma (PPAR-gamma) is a~     ligand-activated nuclear transcription factor found in cells of the immune system and the~     vasculature, where it exerts an overall protective effect on the development of~     atherosclerosis, in part through modulation of inflammation. The agonists for PPAR-gamma~     improve not only the insulin resistance, but also have profound beneficial effects on~     inflammation, oxidative stress, endothelium, and lipid metabolism. In this proposal, the~     investigators hypothesize that short-term administration of a PPAR-gamma agonist~     (pioglitazone) will improve the inflammatory state, insulin resistance, and endothelial~     dysfunction in chronic kidney disease patients with advanced uremia.~   "
243431|NCT00368004|"~     This study will identify the genes responsible for uveal coloboma, an abnormal development of~     the eye caused by incomplete closure of a normally-occurring gap in the eye (the optic~     fissure) after the fifth week of life in a human embryo. There have been studies of families~     in which more than one person has been affected by this disorder. Coloboma occurs in about 1~     of 10,000 live births and may cause significant vision loss. Researchers seek a better~     understanding of the genes responsible for this disorder.~      Adults and children who have more than one member of the family with uveal coloboma may be~     eligible for this study. Patients will undergo a detailed medical history and eye examination~     appropriate for their age. The pupils will be dilated, through the use of eye drops. Dilation~     will continue for 4 to 6 hours, and wearing of sunglasses can reduce temporary glare that~     many patients may experience in brightly lit areas. In addition, pictures will be taken of~     the front or back of the eye, a procedure that also involves dilation of the pupils. Patients~     who have coloboma will undergo a complete physical examination. Blood samples will be~     collected, with a total of about 2 tablespoons from patients ages 10 and older and about 1~     teaspoon for each 5 pounds of body weight for younger patients. Also, patients with coloboma~     may be asked to undergo X-rays , ultrasound, or other tests that are medically indicated.~      To have enough DNA to study, the researchers may create a cell line to grow more DNA.~     Laboratory samples will be coded so that there is no identifying information about~     participants in this study. No other testing or research will be done on blood samples~     collected unless patients give permission. The researchers will not provide information about~     patients' health to other people without your express permission.~   "
243432|NCT00367991|"~     The purpose of this study is to see if a naturally-occurring hormone called erythropoietin~     changes the action of platelets in the blood. Patients with heart attacks are treated with~     medicines to reduce the clotting action of platelets. This study is trying to determine~     whether erythropoietin alters the clotting action of platelets in patients receiving~     anti-platelet medicines. It is important to understand the effects of erythropoietin on~     platelets since preliminary studies in animals suggest that erythropoietin may protect the~     heart from damage during a heart attack.~   "
243433|NCT00367978|"~     This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of~     enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.~   "
243434|NCT00367965|"~     To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia~     related to rheumatoid arthritis (RA).~   "
243435|NCT00367952|"~     The study will examine how safe and effective apricitabine is when given long term (as~     ongoing treatment) to HIV patients who have already completed the AVX-201 trial~   "
243436|NCT00367939|"~     The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in~     hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel~     blocker~   "
243437|NCT00367926|"~     To determine the effect of polysaccharides from American ginseng root on postprandial~     glycemia in healthy individuals.~   "
243438|NCT00367913|"~     To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist~     Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active~     in vitro against these species of mycobacteria. The primary aim of this study was to compare~     these to agents as supplements to rifampicin and ethambutol. A secondary aim was to assess~     the vale of immunotherapy with M.vaccae.~   "
243439|NCT00367900|"~     This study will examine the roles of diet, lifestyle, genes, and their possible interactions~     in the cause of Parkinson's disease, using information from the NIH-AARP Diet and Health~     Study. The NIH-AARP study was established in 1995 to examine the roles of diet and lifestyle~     in cancer. It included 567,169 AARP members 50 or older from California, Florida, North~     Carolina, Pennsylvania, New Jersey, Louisiana, and the Atlanta and Detroit metropolitan~     areas. In 1995, participants completed a comprehensive questionnaire on diet and a survey on~     demographics, medications, as well as a follow-up survey in 1996 with more detailed questions~     on lifestyle and medications, as well as cooking methods and early life dietary habits. A~     third followup survey is currently underway.~      The current NIH-AARP substudy on Parkinson's disease will include approximately 9,000~     participants from the NIH-AARP study - 3,000 of whom reported being diagnosed with~     Parkinson's disease on the most recent survey, and 6,000 control subjects. These study~     participants provide two saliva samples for genetic analysis and may be asked to complete a~     telephone interview. In addition, those with Parkinson's disease are asked permission to~     review medical information regarding their diagnosis.~   "
243440|NCT00367887|"~     This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and~     pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B~     (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV)~     genotype~      1-infected subjects who are either naive to treatment or who have previously failed treatment~     (non-responders).~   "
243441|NCT00367874|"~     Managed detoxification is a first and necessary step prior to treatment and rehabilitation.~     Detoxification can be a major obstacle for some patients, and the availability of managed and~     safe withdrawal is a prerequisite for long-term treatment.~      In our clinical practice we have felt the need for a standardised and safe detoxification~     treatment regimen for our opioid addicts, as dependence on multiple drugs is so common.~      Objectives~        1. To assess whether a novel standardised treatment regimen - Buprenorphine (BPN) combined~          with Valproate (VPA) - will result in fewer withdrawal symptoms during detoxification of~          opiate–polydrug users than the existing treatment regimen, i.e. Clonidine (CLN) combined~          with Carbamazepine (CBZ).~        2. To determine whether there are differences in treatment retention between the BPN/VPA~          and the CLN/CBZ groups.~        3. To assess differences in clinical side-effects and biochemical interactions between the~          two treatment regimens.~   "
243442|NCT00367861|"~     Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized~     and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all~     malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells,~     leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in~     vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with~     advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal~     duration of treatment with Glivec® remains unknown. The objective of this study is to~     determine the feasibility of Glivec® treatment interruption with reintroduction at~     progression in GIST patients.~   "
243443|NCT00367848|"~     The purpose of the study is to examine the efficacy and accuracy of Ultrasound in evaluating~     occult fractures. We want to examine it on children that suffer from suspected fractures of~     the foot and ankle and the results of the x-ray are either negative or inconclusive.~   "
243444|NCT00367835|"~     To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and~     oppositional symptoms.~   "
243445|NCT00367822|"~     The objective of this trial is to compare an individually optimized dose of the lisuride TTS~     patch against placebo and against an individually optimized dose of oral ropinirole (active-~     and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy,~     safety, and quality of life.~   "
243446|NCT00367809|"~     The Wellness Interventions after Transplant (WIAT) Trial has reached its enrollment target.~     This trial is no longer recruiting new patients. Those currently enrolled will be followed~     for a year to evaluate trial outcomes.~      The purpose of this trial is to determine if training in Mindfulness-Based Stress Reduction~     can reduce symptom distress and improve quality of life in solid organ transplant recipients.~     Primary study outcomes are depression, anxiety and insomnia symptoms, measured by~     well-validated self-report scales. The impact of this program on objectively measured sleep~     outcomes, use of health care resources and costs will also be evaluated.~   "
243447|NCT00367796|"~     This study will try to find the gene changes responsible for the birth defects in~     craniosynostosis, Philadelphia type. Craniosynostosis syndromes are a group of conditions~     that result from closure of one or more of the fibrous joints between the bones of the skull~     before brain growth is complete. Because of the premature closure, the brain is not able to~     grow in its natural shape; instead, it compensates with growth in areas of the skull where~     the joints have not yet closed. The defects in raniosynostosis, Philadelphia type, include~     skull malformations and webbing of the fingers and toes. Gene changes known to be involved in~     other craniosynostosis syndromes have not been found in the Philadelphia type syndrome.~     Therefore, finding the genetic basis of this disorder will provide important new information~     regarding craniofacial and limb development.~      This study includes members of a single large family affected with craniosynostosis,~     Philadelphia type.~      Participants have 1 to 2 teaspoons of blood drawn for genetic studies. A second blood sample~     may be requested for further research. Some blood may be used to establish a cell line for~     later studies. This involves growing the white blood cells from the blood sample. The cells~     can be kept in the laboratory to make more DNA or can be frozen for later use in~     craniosynostosis studies. Patients may also have their medical records reviewed.~   "
243448|NCT00367783|"~     The purpose of this study is to determine whether CP-741,952 is effective in the treatment of~     obesity and to determine 12 week safety and toleration.~   "
243449|NCT00367770|"~     This 6-month open label study will evaluate the long term safety of bosentan (via oxygen~     saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5~     study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.~   "
243477|NCT00367393|"~     Topical steroid use may lead to skin deterioration and spider veins. This study will examine~     long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and~     its effect on skin reconstitution of steroid-damaged skin and disease control.~   "
243452|NCT00367731|"~     After Initiation of HAART in peoples who living with HIV/AIDS in Thailand by the year 2000,~     rapidly expanded HAART access of national project has been promoted in 2004. Free ARVs (For~     CD4<200cell/cu.mm. or in symptomatic HIV with CD4<250 cell/cu.mm. )and CD4 monitoring has~     been available. The first-line regimen is d4T+3TC+NVP in mainly the first time (Naive)~     patients. CD4 response ), rate of opportunistic infection, and neurological outcomes were~     measured. Rate of ARV change, adverse events,treatment failure, TB co-infection rate, percent~     changing to EFV-based regimen or PI-based regimen were recorded.~      Any Adverse Events including, Sever rash, Severe Hepatitis, Lipid abnormalities, Severe~     Anemia and Other, common AEs will be analysed.~   "
243453|NCT00367718|"~     This study seeks to test the Efficacy in terms of rates of disease response in metastatic~     nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and~     11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between~     15-25 patients. Secondary endpoints studied include Pharmacokinetics, toxicities, EBV viral~     load and molecular characterization of EBV in plasma.~   "
243454|NCT00367705|"~     Crohn's disease (CD) in childhood is a chronic relapsing and remitting condition that has a~     significant impact on growth and development. The disease is characterized by an increased~     and unregulated immune response. The main therapy over the last 30 years has been~     corticosteroids leading to remission in 50-80% of patients within 2-4 weeks. However, the use~     of steroids in children is limited by side-effects including acne, moon-face, hirsutism,~     hypertension, metabolic disturbances and above all reduced growth. Hence, pediatricians are~     very interested to find alternative therapies. Therapeutic manipulation of gut flora with~     probiotics promises to be a useful strategy for several disorders including inflammation of~     the gut. The efficacy of the highly concentrated probiotic VSL#3 has been documented in~     maintenance and prophylaxis treatment of pouchitis in double blind, placebo controlled~     studies in adults. The aim of this study is to compare probiotic therapy with VSL#3 versus~     placebo in maintenance therapy of children with mild to moderate CD, treated with either~     5-ASA, corticosteroids (local or budesonide), imuran/6 mercaptopurine (MP), as long as no~     change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4~     weeks (for corticosteroids).~   "
243455|NCT00367692|"~     To evaluate the safety of an orally administered single dose of PSI-697 in subjects with~     scleritis, as a model of inflammatory disease. To evaluate by in vivo confocal microscopy~     (IVCM) the effect of a single dose of PSI-697 on leukocyte rolling in the scleral blood~     vessels of subjects with scleritis.~   "
243456|NCT00367679|"~     This is a phase 2 open-label, multicenter, non-randomized study to evaluate the safety and~     efficacy of oral pazopanib as neoadjuvant treatment for patients with stage 1A, 1B, IIA or~     IIB (to T2) resectable Non-Small Cell Lung Cancer (NSCLC).~   "
243457|NCT00367666|"~     This project is aimed at investigating the relative diagnostic and synergy of four state of~     the art breast imaging techniques (magnetic resonance imaging (MRI), full-field digital~     mammography (DMAM), ultrasound, and positron emission tomography (PET)) with respect to~     determining the extent of breast cancer.~   "
243458|NCT00367653|"~     To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium~     falciparum malaria.~   "
243459|NCT00367640|"~     To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms~     and rescue medication usage~   "
243460|NCT00367627|"~     The most common soil transmitted helminthic infections(STHI) includes infection with Ascaris~     lumbricoides, Trichuris trichiura, and Hookworm. Growth retardation, malnutrition, anemia,~     impaired cognitive function and immunosuppression are main manifestations in children. Even~     within the developing world, wide differences exist in prevalence rates. The poorest~     countries have higher levels of STHI than those with a lower incidence of poverty. According~     to an estimate made by the WHO, the prevalence of A. lumbricoides, T. trichiura and Hookworm~     in South Asia was 27%, 20% and 16% respectively. Given that the prevalence of STHI in urban~     slums in Bangladesh is much higher than the other parts of the world and Asia and that there~     are major health and socio-economic consequences of such infections, it is important that we~     come up with effective means of reducing the prevalence of such infections. 60-80% of~     preschool children in urban slums of Bangladesh are infected with these STHI due to poor~     hygiene . At present deworming at six months interval is recommended but the effectiveness of~     this regimen of dewormig is questionable.~      2. Hypothesis: Ante-helminthic treatment at every three month is more effective than~     ante-helminthic treatment at every six months to reduce soil transmitted helminthic~     infection, to reduce diarrheal and respiratory illness to improve nutritional status in~     preschool children.~      3.Objective: The main objectives of the proposed study is to compare the relative efficacy of~     two different ante-helminthic treatment regimens to reduce the prevalence of STHI, diarrheal~     diseases, respiratory illness and to improve nutritional status in children 4. Design: The~     population of the study will be preschool children aged 2-5 year and will be selected~     randomly from an urban of Dhaka. They will be divided into two groups randomly. One group~     will get ante-helminthic at every three months interval and the other groups will get at six~     months interval for one year. Stool samples will be collected at the baseline and after three~     months completing one-year treatment of the above mentioned regimen. Blood haemoglobulin and~     nutritional status will also be measured at baseline and after three months of completion of~     treatment as mentioned above. The treatment will be 400 mg of Albendazole in a single dose.~      5. Potential Impact: The findings of the research can be implemented by the government and~     non-government organization.~   "
243461|NCT00367614|"~     The purpose of this study is characterize the PK profile of single and multiple doses of~     pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).~   "
243462|NCT00367601|"~     The strategy for combining therapeutic agents in cancer treatments has been successful in~     multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways~     involved in tumor growth. Nonclinical studies have demonstrated that the combination of~     bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore,~     because there is little to no overlap in toxicity profile between the two agents, the~     combination is expected to be well tolerated and may provide even greater benefit for~     patients who are unable to receive cytotoxic therapy.~   "
243463|NCT00367588|"~     The purpose of this prospective, randomized study was to determine the efficacy of low~     bacterial diet, in comparison to normal hospital diet, with gut colonization by aerobic Gram~     negative rods and yeasts as primary endpoint. In addition, the occurrence of infections and~     the total costs of hospital care were documented, in order to identify potential cost savings~     by the use of either diet.~   "
243500|NCT00367094|"~     This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult~     Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure~     is not adequately controlled with benazepril monotherapy during a 4 week run-in period will~     be randomly allocated to double blind treatment over 8 weeks with either a combination of~     benazepril/hydrochlorothiazide per day or continuation of benazepril per day.~   "
243547|NCT00366483|"~     To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral~     doses of lecozotan SR in healthy young and elderly subjects.~   "
243464|NCT00367575|"~     The main aim of this randomized controlled trial is to evaluate the efficacy of an~     Internet-delivered self-help intervention for problem drinkers in the general population.~      Adult problem drinkers with home access to the Internet will be recruited from the CAMH~     Monitor. Subjects will be randomly assigned to receive a website address where they can~     obtain personalized feedback about their drinking, or to a no intervention control group.~      Three-month and six-month follow-up surveys will be conducted by mail to assess drinking over~     the following three month periods. Collaterals will be requested and interviewed after the~     six-month follow-up. Subjects will be paid $40.00 and collaterals will be paid $20.00 for~     their participation. Drinking at three- and six-months will be compared between the groups.~     Subjects in the control group will be provided with the website address following the~     six-month follow-up.~   "
243465|NCT00367562|"~     TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT~     OF PROTEINURIA IN IGA NEPHROPATHY~   "
243466|NCT00367549|"~     This is a randomized, double-blind trial looking at how nutrition intake is associated with~     labor progress and complications.~   "
243467|NCT00367536|"~     This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also~     called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).~      About 24 subjects will take part in this study. Each subject's participation in this study~     will last for about 10 weeks. During this study, each subject will receive 3 different types~     of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to~     learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA~     oral solution. In addition, information will also be learned about the safety and~     tolerability of these dosage forms given to healthy postmenopausal women.~   "
243468|NCT00367523|"~     This study will explore how people with sickle cell disease (SCD) develop a complication~     called pulmonary hypertension (PHTN), a serious disease in which blood pressure in the lungs~     is higher than normal. PHTN is also caused by HIV, hepatitis C and schistosomiasis. Patients~     who have both SCD and one of these other infections may develop more severe PHTN. The number~     of Nigerians with SCD who also have PHTN is not known, nor is the cause of PHTN in this~     population. This study will examine genetic material in people with and without SCD to~     determine whether certain genes will allow doctors to predict which patients with SCD are~     likely to develop PHTN.~      Nigerian males and females 10 years of age and older with or without SCD may be eligible for~     this study. Patients must have SS, SC, or SB thalassemia or other genotype; control subjects~     must have hemoglobin A or AS genotype.~      Participants undergo a complete medical history and physical examination, blood tests,~     electrocardiogram (EKG), ultrasound tests of the heart and abdomen, and a 6-minute walk~     (distance test) to determine exercise capacity. Blood tests include screening for HIV,~     hepatitis B and C, schistosomiasis, hookworm and malaria. Patients who test positive for HIV,~     hepatitis B or C, schistosomiasis, hookworm or malaria are referred for treatment at Ahmadu~     Bello University Teaching Hospital in Zaria, Nigeria, and those who test negative for~     hepatitis B are referred for vaccination. Genetic tests focus on genes involved in SCD, PHTN,~     inflammation, blood vessel function and red blood cell function.~   "
243469|NCT00367497|"~     Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes~     refractory to chemotherapy. Various second or third line chemotherapies, which are called~     salvage chemotherapy, were developed without promising results. Improvement in efficacy by~     adding relatively new agent, rituximab, to chemotherapy is now widely accepted in~     non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to~     existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose~     chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP~     therapy.~   "
243470|NCT00367484|"~     The objectives of the study are:~      - comparison of the incidence and time course of the development of neutralizing antibodies~     (NAbs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial~     databases to assess the safety and tolerability of Rebif®~   "
243471|NCT00367471|"~     The purpose of this study is to determine the optimal dose of lapatinib when administered~     with carboplatin, paclitaxel, and trastuzumab in subjects with ErbB2-positive breast cancer~     and with carboplatin and paclitaxel in subjects with ErbB2-negative breast cancer.~   "
243472|NCT00367458|"~     This study will examine the effects of atorvastatin, a statin (drug that lowers cholesterol)~     on the human immunodeficiency virus (HIV). If not treated, HIV infection causes an incurable,~     progressive deficiency in the immune system that leads to death, usually from disease that~     takes advantage of weakened immunity. However, previous studies have suggested that if the~     amount of cholesterol in infected cells is reduced, multiplication of HIV is also reduced. In~     this study, researchers will examine the HIV viral loads, that is, amount of the virus in the~     blood. They will evaluate the composition of the strain of the virus that patients carry (HIV~     genotype), response of the immune system to the virus, and how genes may determine the way in~     which the drug may or may not work against the strain of virus. Researchers plan to enroll 22~     participants, anticipating a study to last 30 weeks for each participant.~      Patients ages 18 or older with HIV infection, who are not pregnant or breastfeeding, who do~     not have a known allergy to atorvastatin use, and who have not had a serious illness or~     infection that required hospitalization within the 30 days before entering the study may be~     eligible for this study. They will be assigned to random groups: one that to receive~     atorvastatin and the other to receive a placebo, which has no effect on cholesterol or~     ability of the HIV infection to multiply. Patients will remain in their groups and treatments~     for 8 weeks. At the completion of 8 weeks, no matter the study group, all patients will be~     required to discontinue all study-related medications for 4 weeks. After that period, the~     study assignments will be switched, so that those previously taking the placebo will take~     atorvastatin, and vice versa. The study will proceed for another 8 weeks, followed by a~     period of stopping study-related medications and patients being observed for 4 weeks.~     Throughout the study, patients will have regularly scheduled visits at the clinic. At those~     visits there will be collection of blood samples, assessments of symptoms, physical~     examinations, and questionnaires to complete. Blood tests may require fasting beforehand, and~     blood samples will be used in standard tests, including those regarding the liver, kidneys,~     muscles, blood cells, and pregnancy status. Specialized blood tests will determine viral~     load, effects of the drug on the immune cells, and genetic influence on the drug's~     effectiveness. The time spent for procedures during clinic visits...~   "
243473|NCT00367445|"~     To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2~     diabetes mellitus~   "
243474|NCT00367432|"~     This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in~     long-term administration in patients who completed N01020 [NCT00160165] or N01221~     [NCT00280696].~   "
243475|NCT00367419|"~     We looked for the effectiveness of low-dose long-term prescription of erythromycin in~     mustard-induced bronchiolitis obliterans~   "
243476|NCT00367406|"~     Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an~     ACE Trochanteric nail.~      Following topics will be assessed: fracture consolidation, mobility, pain, walking power,~     agility.~   "
243478|NCT00367380|"~     The study is a randomized open label clinical trial to verify the reproducibility of a~     sporozoite challenge model for Plasmodium vivax in humans. The verification of the~     reproducibility of such a model will make it possible to evaluate the efficacy of candidate~     P. vivax vaccines in Phase 2a trials. The study is divided into two successive steps:~      Step A Parasite Blood Donation: Volunteers will be recruited passively from a group of~     patients who present with active P. vivax infection and accept to donate infected blood.~     Samples of P. vivax infected blood will be collected and will be screened for infectious~     diseases, according to standard blood bank procedures. Colonized Anopheles albimanus~     mosquitoes will be fed with this blood using a Membrane Feeding Assay (MFA). Sixteen (16)~     days after, selected positive mosquito batches will be used for step B.~      Step B Challenge: After informed consent signature, a total of 18 healthy volunteers will be~     randomly allocated to Groups 1, 2 and 3, of 6 volunteers each and will be challenged with the~     bite of 3±1, P. vivax infected mosquitoes. Each group will be exposed to a different isolated~     parasite. Volunteers will be closely monitored post infection, and will be treated as soon as~     blood infection becomes patent as ascertained by microscopic examination of thick blood~     smears (TBS). Comparison of data obtained in the three different groups will be used to~     determine reproducibility of challenge model.~      Primary objective: To demonstrate that naïve human volunteers can be safely and reproducibly~     infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites in their~     salivary glands.~      Secondary objective: To determine the influence of the type of parasite isolated on~     reproducibility and safety of the challenge model with P. vivax in human volunteers~      Hypothesis:It is possible to safely develop a reproducible P. vivax infection in human~     volunteers using P. vivax experimentally infected An. albimanus mosquitoes.~   "
243479|NCT00367367|"~     Studies have shown that endometrial sampling in the month prior to embryo transfer may~     increase pregnancy rates. We wish to test this hypothesis by performing a hysteroscopy and~     curettage in the month proceeding embryo transfer during IVF, IVF/ICSI or Frozen/Thawed~     cycles.~   "
243480|NCT00367354|"~     The purpose of this project is to analyze the respiratory motion process as relevant in~     cardiac MRI imaging and apply the results for development of improved imaging methods and~     software correction. To accomplish this, we will develop an imaging protocol for monitoring~     respiratory motion.~      The imaging protocol will be limited to less than five minutes of acquisition time so it may~     be performed as piggyback acquisition following clinically prescribed imaging studies on~     pediatric and adult cardiac MRI patients, but will also be applied to normal healthy~     volunteers.~      Hypothesis Characterization of respiratory motion will help improve image quality by allowing~     optimized scan acquisition and retrospective correction of acquired data.~   "
243481|NCT00367341|"~     While there are many effective options for treating a major depressive episode, there are no~     clinical markers that predict the likelihood of remission with an initial trial of either an~     antidepressant medication or psychotherapy. More critically, there are also no reliable~     predictors that might anticipate failure to such standard treatments either alone or in~     combination. This project will characterize imaging-based brain subtypes that distinguish~     groups of depressed patients who later remit or not to SSRI pharmacotherapy or cognitive~     behavior therapy (CBT), respectively. To define these subtypes, a prospectively-treated~     cohort of 100 patients will be randomized to receive either escitalopram (s-CIT) or CBT for~     the first 12 weeks, with non-remitters to either first treatment crossed over to receive an~     additional 12 weeks of treatment with combined treatment. Non-remitters to both treatments~     will thus define a relatively treatment resistant third subgroup. Resting-state~     18F-fluoro-deoxyglucose (FDG) positron emission tomography (PET) scans will be acquired prior~     to initiating antidepressant therapy, with pre-treatment scan patterns associated with three~     possible outcomes (CBT remission, s-CIT remission, and non-remission to both) assessed using~     multivariate analytic methods. A second PET scan, acquired early in the treatment course,~     will be used to assess the likelihood of response to the specific treatment first assigned.~     The proposed studies are a first step towards defining brain-based biomarkers predictive of~     differential treatment outcome in major depression; most critically, patterns distinguishing~     patients at risk for treatment resistance. Identification of such biomarkers has additional~     implications for future testing of novel therapies in patients with distinct brain~     signatures, including development of evidence-based treatment algorithms for individual~     patients.~   "
243482|NCT00367328|"~     A research study to determine the efficacy of a 1320 nm laser device for the treatment of~     hidradenitis suppurativa.~   "
243483|NCT00367315|"~     This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of~     patients with knee osteoarthritis (OA)~   "
243484|NCT00367302|"~     The purpose of the study is to determine the feasibility of providing buprenorphine~     maintenance to opioid-dependent offenders in a jail setting and of transitioning those~     patients to buprenorphine maintenance in the community after their release.~   "
243485|NCT00367289|"~     All patients over 18 who undergo a revision of hip or knee arthroplasty will be included.~     Patients undergo a CT of the hip joint. A radiologist will mark the presence of cysts and~     bone loss and will assess implant stability.~      After the surgery, the surgeon will fill a similar form.~   "
243486|NCT00367276|"~     The purpose of this study is to evaluate the effects on the quality of life and BMI of new~     contraceptives.~   "
243487|NCT00367263|"~     This study is designed to evaluate a traditional paper symptom diary system versus the VOCEL~     Mobile Diary. Subjects will be issued in a random order each system and asked their~     preference at the end of their participation.~   "
243488|NCT00367250|"~     One important approach to change the natural history of advanced breast cancer is that of~     designing new combination chemotherapies in which the best drugs already available are used~     together with new anticancer agents devoid of clinical cross-resistance. The possibility of~     exploiting the combined use of cetuximab and trastuzumab represents an option of potential~     great impact on the probability of response and long-term therapeutic results for patients~     with advanced breast cancer and HER2 overexpression.Therefore, patients with tumors that~     demonstrate EGFR expression and clear-cut erbB-2 overexpression (3+) or limited erbB-2~     overexpression (+ or 2+) will be included in the study. Patients will be treated with~     trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction~     of both antibodies as well as the safety and tolerability of this novel combination~     treatment.~   "
243489|NCT00367237|"~     This study is undertaken to compare the efficacy and onset of action of infliximab plus~     methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active~     psoriatic arthritis patients.~   "
243490|NCT00367224|"~     The purpose of this study is to determine if vitiligo patients develop tolerance to~     ultraviolet light therapy, a type of treatment available for vitiligo.~   "
243491|NCT00367211|"~     The purpose of this study is to evaluate the incidence of gastric ulcers following~     administration of either PN 200 or Naproxen in subjects who are at risk for developing~     NSAID-associated ulcers.~   "
243501|NCT00367081|"~     Neurological manifestations of Cerebral toxoplasmosis or Toxoplasmic encephalitis (TE) in~     most advance stage HIV infected patients composed of fever, headache, alteration of~     consciousness with focal neurological signs/symptoms such as include hemiparesis, cranial~     nerve palsies, and ataxia. Generalised convulsions, in ¾ of patients. Moreover meningeal~     irritation sign or herniation sign may be presented as life threatening condition~   "
243502|NCT00367068|"~     The objective of this study is to determine the efficacy and safety of treatment with~     intrathecal baclofen for severe spasticity in children with cerebral palsy.~   "
243492|NCT00367198|"~     The mortality rate in chronic hemodialysis (CHD) patients remains excessively high and~     approaches 21% per year. Among the many factors that adversely affects patient outcome is~     uremic malnutrition, a unique form of deranged nutritional status. It is associated with~     increased hospitalization and death risk in CHD patients. Several measures have been~     identified to prevent uremic malnutrition in CHD patients, including efforts to optimize~     dialysis regimen and dietary protein and energy intake. A large number of CHD patients suffer~     from uremic malnutrition in spite of these aggressive measures. The inevitable protein~     catabolic effects of the hemodialysis procedure are important factors leading to increased~     prevalence of uremic malnutrition. Preliminary data suggest that oral nutritional~     supplementation administered during the hemodialysis procedure counteracts these protein~     catabolic effects and leads to net protein anabolism in the acute setting. In this proposal,~     we hypothesize that Pro-Stat, a high nitrogen, enzyme-hydrolyzed, tryptophan-fortified,~     collagen protein supplement will reverse the net protein catabolism observed during~     hemodialysis procedure.~   "
243493|NCT00367185|"~     In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used~     since the 1960s and is regarded as the standard of care in elderly patients. We assess~     whether the addition of thalidomide to this combination or adapted high-dose chemotherapy,~     using a melphalan 100 mg/m2 -based regimen, would improve survival.~   "
243494|NCT00367172|"~     The goal of this randomized, controlled trial is to compare the effectiveness of a~     community-based program of providing supervised antiretroviral therapy to HIV-positive drug~     users, compared to having the patients take the medicines on their own.~   "
243495|NCT00367159|"~     Urinary tract infection (UTI) is a common problem in childhood associated with vesico-renal~     reflux (VRR) in 25-40% of children. A persistent VRR and repeated pyelonephritis may~     predispose to renal scarring and chronic renal failure with an end-stage renal failure in up~     to 3% of children.Defining a standard behaviour facing VRR in children is not easy because of~     the lack of reliable evidence. Numbers of studies compare prospectively or retrospectively,~     medical, endoscopical and surgical treatment.Surgical techniques are effective but invasive~     and not free of complication. Medical treatment is submissive to a good observance. The~     introduction of endoscopic techniques permits to prevent UTI and new renal failure by VRR~     elimination. Since the beginning of the endoscopic treatment, several bulking agents have~     been proposed. The ideal agent should be easy to inject, stable in time and should be safe.~     Of course it should be at least as efficient as actual bulking agent. The use of Teflon was~     the first wave of success of endoscopic treatment. But sudden passion of Teflon has been~     darkened by the notion of migration. Since, others substances have been proposed, autologous~     or exogenous, resorbable or not. But none was ideal and no solutions were found facing~     problem of biocompatibility or long-term stability.Using adipose tissue as a bulking agent is~     ancient in plastic surgery and indications had known a leap forward in the last century with~     Coleman who introduced a new technique called lipostructure. This technique has known a~     growing interest in the restoration of all volume defects in plastic surgery because of the~     stability of the graft. We propose to apply this technique to VRR management in children in~     order to combine innocuousness and efficiency.~   "
243496|NCT00367146|"~     The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver~     transplantation is one of the main causes of chronic kidney disease in these patients in the~     long term.~      The study objective is the evaluation of safety of a modification in immunosuppression from a~     dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA~     (reduced dosage) plus steroids.~   "
243497|NCT00367133|"~     The study involves the enrollment of patients over 18 years of age with diabetic macular~     edema(DME). Patients with one study eye will be randomly assigned (stratified by visual~     acuity and prior laser) with equal probability to one of the three treatment groups:~        1. Laser photocoagulation~        2. 1mg intravitreal triamcinolone acetonide injection~        3. 4mg intravitreal triamcinolone acetonide injection~      For patients with two study eyes (both eyes eligible at the time of randomization), the right~     eye (stratified by visual acuity and prior laser) will be randomly assigned with equal~     probabilities to one of the three treatment groups listed above. The left eye will be~     assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned~     to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with~     equal probability (stratified by visual acuity and prior laser).~      The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal~     injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will~     receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will~     be better.~      Patients enrolled into the study will be followed for three years and will have study visits~     every 4 months after receiving their assigned study treatment. In addition, standard of care~     post-treatment visits will be performed at 4 weeks after each intravitreal injection.~   "
243498|NCT00367120|"~     This study will enroll patients with Bacterial Sinusitis who will be treated with either Zmax~     (Azithromycin Extended Release) or Augmentin (Amoxicillin/Clavulanate). The purpose of the~     study is to compare early resolution of symptoms between the two treatments. Patients will~     report resolution of their sinusitis symptoms through a daily questionnaire. There will be~     two follow-up telephone interviews on days 12 and 28 to evaluate quality of life,~     satisfaction with therapy, and use of healthcare services.~   "
243499|NCT00367107|"~     Background: The number of adults with autism is expected to rise significantly in the near~     future, due to two main reasons: First, a dramatic increase in the estimates of the~     prevalence of autism starting in the mid 1980s; Second, the clinical diagnosis of autism was~     first introduced during the 1950s, and those diagnosed with autism back then are only now~     entering middle age. Few studies, however, have focused on the outcomes of adult autistic~     individuals, and very little is known about the course of autism in adulthood and on the~     familial burden resulting from caring for an autistic adult. We therefore propose to study~     adult outcomes in autism, and to examine the influence of raising an autistic individual on~     the parents.~      Working hypothesis and aims: The primary objectives of the study are:~        1. Determine clinical status and functioning of autistic adults.~        2. Study the influence of raising and caring for an individual with autism on the~          well-being of the parents.~   "
243534|NCT00366652|"~     The purpose of this study is to evaluate the effects of multiple doses of DVS SR and~     duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.~   "
243503|NCT00367055|"~     It has been shown in previous study that progressive glycemic deterioration was associated~     with progressive loss of b-cell function, measured by the decrease in plasma insulin levels,~     irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence~     that thiazolidinediones could have a positive action on the b-cell function. But it has not~     yet been demonstrated that they could protect from a deterioration in insulin secretion in~     the long term. So, it appears interesting to study the long term evolution of the b-cell~     function and the possible protection with rosiglitazone in patients with type 2 diabetes~     showing evidence of loss of b-cell function with metformin alone.~   "
243504|NCT00367042|"~     Mohs Micrographic Surgery is a well established method for treatment of cutaneous~     malignancies. Part of this technique requires marking skin surrounding the tumor. There are~     two ways of marking the tissue, lightly scoring it with a scalpel or marking it with a~     surgical marker.~      This study is to determine if there is a noticeable difference in outcome between patients~     who have their tissue lightly scored with a scalpel or marked with a surgical marking pen.~   "
243505|NCT00367029|"~     Individuals who are not physically active are at risk for developing heart disease, stroke,~     and diabetes. Using motivational print materials is one way to encourage individuals to~     increase their physical activity. This study will evaluate the effect that an enhanced~     version of an individualized, print-based motivational program has on increasing physical~     activity among sedentary individuals.~   "
243506|NCT00367016|"~     The purpose of this study is to look at measures that will help scientists understand the way~     Omalizumab, an FDA-approved anti-allergy medication, works.~   "
243507|NCT00367003|"~     The purpose of the proposed study is to evaluate the safety, feasibility and efficacy of~     chronic, high frequency stimulation of the subgenual cingulate white matter (Cg25WM) using~     the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for~     severe treatment-refractory Major Depression in twenty TRD patients, and to investigate~     potential mechanisms of action of this intervention.~   "
243508|NCT00366990|"~     Obese individuals are at risk for developing cardiovascular disease (CVD). Increasing~     physical activity, losing weight, and reducing sodium intake may reverse arterial stiffness~     and blood vessel damage that is linked to obesity. This study will evaluate the effectiveness~     of a low sodium diet and a behavioral weight loss intervention in reducing arterial stiffness~     in overweight young adults.~   "
243509|NCT00366977|"~     State-sponsored anti-tobacco campaigns are motivating large numbers of smokers to seek~     advice, assistance, and support to make their cessation efforts more successful. Like many~     states, Oregon has sponsored the implementation of a statewide telephone quitline to provide~     information, referrals, and cessation support for callers. This study will answer key policy~     questions about how to most effectively support smokers who call the Oregon Quitline for~     assistance. The specific aims are to recruit 4,500 callers to participate in a 3 x 2~     randomized trial comparing the cost and cost effectiveness of three levels of behavioral~     intervention. We will also test two different policies on the availability of nicotine patch~     therapy. Subjects will be interviewed by telephone at 6 and 12 months to assess smoking~     status, quit attempts, and use of health plan anc community cessation services. Costs will be~     assessed separately from the perspectives of the patients, health plans, the State (i.e.,~     Oregon Quitline), and society. Cost per quit and cost per year quality-adjusted years of life~     saved will be calculated from each of these perspectives.~   "
243510|NCT00366964|"~     This study is being done to compare the efficacy of an FDA cleared laser device with other~     similar systems in the market for the treatment of leg veins and hair removal in patients~     with darker skin type.~   "
243511|NCT00366951|"~     Our purpose was to compare the efficacy and safety of Foley catheter with oxytocin and~     extraamniotic saline infusion with oxytocin for induction of labor requiring cervical~     ripening.~   "
243512|NCT00366938|"~     This study will investigate the efficacy and safety of lumiracoxib in patients with primary~     knee osteoarthritis (OA).~   "
243513|NCT00366925|"~     The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments~     over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks,~     followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active~     ulcerative colitis.~   "
243514|NCT00366912|"~     Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of~     transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading~     during non-invasive ventilation.~      The study makes comparison of a new developed auto adjusting controlled mode and a regular~     spontaneous mode.~   "
243515|NCT00366899|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given~     concomitantly with routine paediatric vaccinations in Italy.~   "
243516|NCT00366886|"~     The purpose of this current retrospective study is to perform follow-up analysis on the 22~     children from the study # 621-2004 It is important to examine whether an elevated biomarker~     of brain ischemia before and/or following cardiac surgery has any clinical or functional~     implications as the child ages.~   "
243517|NCT00366873|"~     The purpose of this study is to measure calcium absorption in infants fed formula with and~     without prebiotics.~   "
243518|NCT00366860|"~     A study was designed with two specific aims: (1) to assess the effect of soy bread, compared~     with wheat bread, on markers of bone metabolism and cardiovascular health, and (2) to~     evaluate whether soy bread consumption affects the metabolism of phytoestrogens. To answer~     Aim 1, a double-blind randomized crossover trial was conducted. Individuals with an ability~     to metabolize a specific isoflavone, daidzein, consumed 3 slices of bread (either soy or~     wheat) daily over a 12-week period. After a 4-week wash-out period, subjects consumed 3~     slices/day of the other type of bread. Markers of bone metabolism and cardiovascular health~     were evaluated before and after each time period. To answer Aim 2, individuals who did not~     metabolize daidzein at baseline entered a double-blind randomized trial of soy bread with or~     without fructooligosaccharide (a type of dietary fiber) over an 8-week period. Subjects were~     evaluated regarding their ability to metabolize daidzein to equol.~   "
243535|NCT00366639|"~     The purpose of the ADHERE study is to develop a multi-center, observational, open-label~     registry of the management strategies of patients treated in the hospital for acute Heart~     Failure in the United States.~   "
243519|NCT00366847|"~     This proposal is aimed at developing a novel method for modeling and analyzing clinical~     factors impacting RV function, which can lead to a more reliable, consistent, and~     comprehensive pre-operative treatment planning. In particular, the proposed work centers on~     the creation of an accurate and clinically useful heart model with which to quantify,~     visualize, and interpret several clinical findings that are central to the medical~     decision-making process. The hypothesis is that by providing clinicians with 3D models that~     capture numerous relevant patient findings in an integrated, quantitative manner they can~     make more consistent, reliable, and accurate clinical assessments and may also be able to~     predict factors complicit in RV dysfunction and impending failure.~   "
243520|NCT00366834|"~     This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus~     dexamethasone and ondansetron is more effective in the prevention of vomiting than~     dexamethasone and ondansetron alone following the administration of moderately emetogenic~     chemotherapy.~   "
243521|NCT00366821|"~     Our hope is that the information from this retrospective study will provide information to~     better serve our patients and their parents with risk stratification (levels of risk) and~     clinical expectations of patients after cardiac surgery who have genetic abnormalities and~     those who do not have genetic abnormalities.~   "
243522|NCT00366808|"~     A recent survey of trends among the members of the American Society of Cataract and~     Refractive Surgery determined that laser in situ keratomileusis (LASIK) is the leading~     surgical procedure for photorefractive corrections ranging from −0 to 3 diopters (D).1 The~     same survey, however, showed a clear trend of participating refractive surgeons toward~     surface ablation. Photorefractive keratectomy (PRK) was the first refractive surgery~     procedure approved and performed using the excimer laser. Several techniques of epithelial~     debridement have been tried with PRK-type surgery including mechanical debridement, laser~     transepithelial ablation, a rotating brush, and alcohol debridement.~      The Amadeus II microkeratome (Advanced Medical Optics Inc, Irvine, CA, USA) used for the~     creation of a LASIK flap has an upgradeable platform that will allow the user to perform~     mechanical separation of the corneal epithelium before photorefractive treatments. With the~     use of this device, the corneal epithelium can be separated from the underlying stroma~     without previous preparation of the corneal surface with alcohol. The separated epithelial~     sheet can either be removed or replaced on the operated cornea after photoablation. This~     surgical procedure, which has been called Epi-LASIK, represents an advanced alternative~     surface ablation photorefractive procedure for the correction of ametropia. The purpose of~     this study is to evaluate the clinical visual outcomes, healing rates, and patient~     satisfaction when performing surface ablation procedures using mechanical vs. alcohol~     separation of the epithelium.~   "
243523|NCT00366795|"~     Primary:~      To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in~     reducing the recurrence of ascites.~      Secondary:~      To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic~     drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent~     ascites.~      The one-year double blind placebo controlled period is extended up to 2 years in a long term~     safety study (PASCCAL-2).~   "
243524|NCT00366782|"~     Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children~     under 5 years of age, causing serious respiratory tract disease. The purpose of this study is~     to test the safety of and immune response to a new HPIV vaccine in healthy infants, children,~     and adults.~   "
243525|NCT00366769|"~     The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare and induced~     high order aberrations induced by the new CustomVue software use for wavefront-guided LASIK.~   "
243526|NCT00366756|"~     This study involves the use of VisionQuest 20/20 which is a new software program to test~     visual acuity in children. The purpose of this study is to compare the results of VisionQuest~     20/20 to two other ways to measure visual acuity. The two other tests are a standard eye exam~     by an ophthalmologist and electronic visual acuity (EVA) testing, a computerized version of a~     standard eye test.~      It is important to identify vision problems in children as early as possible. These problems~     include amblyopia (lazy eye, or reduced vision due to lack of development in the visual~     area of the brain), strabismus (eyes are not aligned correctly due to eye muscle problems),~     and refractive errors (when you need glasses to see up close or far away). Early~     identification of the vision problems allows them to be treated earlier which makes it more~     likely that vision can be improved. VisionQuest 20/20 can be easily distributed to schools,~     and it is easy for the child and the vision screener to use. The test can be performed by~     volunteers instead of an ophthalmologist.~   "
243527|NCT00366743|"~     The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare testing and~     high order aberrations induced by different laser technologies and to evaluate differences in~     aberrometer technology. We hypothesized that there will not be differences among conventional~     or wavefront guided treatments.~   "
243528|NCT00366730|"~     The purpose of this study is to determine the effect of nitazoxanide suspension in treating~     diarrhea caused by Entamoeba histolytica in children.~   "
243529|NCT00366717|"~     Cytomegalovirus (CMV) infects most of the world population. This study is to understand if~     chemotherapy will increase the chance of reactivating CMV. The results may help us in~     determining when treatment is needed and perhaps Why is it needed.~   "
243530|NCT00366704|"~     The purpose of this study is to determine the effect of bifeprunox or risperidone on the body~     weight of patients with schizophrenia.~   "
243531|NCT00366691|"~     The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the~     prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan,~     Inc. It is a nonsteroidal anti-inflammatory drug (NSAID) and is approved by the Food and Drug~     Administration (FDA) for use following cataract surgery. Lotemax is made by Bausch & Lomb. It~     is a steroid and is also approved by the FDA for use following cataract surgery.~   "
243532|NCT00366678|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given~     concomitantly with routine pediatric vaccines in France.~   "
243533|NCT00366665|"~     To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System~     phacoemulsification units during routine cataract extraction.~   "
243537|NCT00366613|"~     This study involves using both a device that seals the capsular bag (where the lens is~     located) allowing safer irrigation of the capsular bag and sodium chloride to irrigate the~     capsular bag during cataract surgery on children. The purpose of this study is to determine~     if the use of the device, Perfect Capsule, along with sodium chloride reduces the development~     of posterior capsule opacification (PCO), a possible complication of cataract surgery. PCO is~     the clouding of the rear portion of the natural membrane or capsule that holds the artificial~     lens. It requires additional procedures to correct the problem. Sodium chloride is not~     usually used during cataract surgery. It will be used to irrigate the capsular bag and remove~     any residual cells that contribute to the development of PCO. Perfect Capsule will prevent~     the sodium chloride from touching other parts of the eye. The goal of this study is to~     determine if irrigation with sodium chloride will lower the incidence of PCO after cataract~     surgery.~   "
243538|NCT00366600|"~     Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the~     same.~   "
243539|NCT00366587|"~     Cataract is prevalent throughout the world and IOLs are routinely implanted after the~     extraction of the cataractous lens. It is the most frequently performed surgery in the United~     States with an estimated 2-3 million procedures performed annually. With the aging population~     on the rise, as well as the increasing popularity of refractive intraocular lenses, the~     number of intraocular surgeries continues to rise. Over the years, the surgical technique has~     evolved from intracapsular extraction to modern phacoemulsification. This development has~     helped with the evolution of IOLs as well. The IOLs have advanced extensively: different~     materials and designs are available, permitting implantation through smaller, sutureless~     incisions. Traditional IOLs are of monofocal design providing vision at one distance,~     typically far. Patients implanted with traditional monofocal IOLs usually require glasses for~     near distance tasks such as reading. The new multifocal IOLs offer the possibility of seeing~     well at more than one distance, without glasses or contacts.~      The AcrySof ReSTOR (Alcon Laboratories) uses apodized diffractive technology — a design that~     responds to how wide or small the eye's pupil might be — to provide near, intermediate, and~     distance vision. Clinical studies used to support the March 2005 FDA approval showed that 80%~     of people who received the lens did not use glasses for any activities after their cataract~     surgery; 84% who received the lens in both eyes had distance vision of 20/25 or better, with~     near vision of 20/32 or better.~      ReZoom (Advanced Medical Optics) is a multifocal refractive zonal IOL that distributes light~     over five optical zones to provide near, intermediate, and distance vision. The ReZoom is a~     second-generation multifocal and was FDA-approved in March 2005. In a European study of 215~     patients, 93% of ReZoom recipients reported never or only occasionally needing glasses. The~     combined use of multifocal intraocular lenses is often a solution to best meet the patients'~     refractive needs. There has been speculation that the implantation of ReSTOR in one eye and~     ReZoom lens in the fellow eye can provide patients a larger range of useful vision in the~     near range.~      The purpose of this study is to evaluate visual outcome and patient satisfaction after~     implantation of a diffractive multifocal IOL (ReSTOR) in one eye and a refractive multifocal~     IOL (ReZoom) in the fellow eye after routine phacoemulsification and compare it to a control~     group of patients implanted bilaterally with ReSTOR with both eyes targeted for 0 to ±0.25 D,~     and to a group of patients implanted bilaterally with ReSTOR with the non-dominant eye~     targeted for +1.00 D and the dominant eye targeted for 0 to +0.25 D.~   "
243540|NCT00366574|"~     The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome~     which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our~     hypothesis is that there is no difference between the 2 devices.~   "
243541|NCT00366561|"~     The purpose of this retrospective study is to identify all neonates (newborns < 30 days of~     age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have~     suffered neurological complications following cardiac surgery. This retrospective study is~     important to identify the incidence, care and follow-up of neurological complications at this~     institution~   "
243542|NCT00366548|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared~     to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given~     concomitantly with routine paediatric vaccinations.~   "
243543|NCT00366535|"~     This study will examine the safety and effectiveness of the experimental drug, neurotropin,~     for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects~     women, fibromyalgia causes widespread aching and stiffness in muscles. Neurotropin has been~     used in Japan for many years to treat various chronic painful conditions, including~     fibromyalgia.~      Women with fibromyalgia who have been treated unsuccessfully with standard therapy may be~     eligible for this study. Patients must have a history of widespread pain for more than half~     of the days in each of the three months before they enter the study. Candidates are screened~     with a medical history, physical examination, blood and urine tests, questionnaires and an~     electrocardiogram (EKG).~      Participants take their usual medications for fibromyalgia in addition to either neurotropin~     or a placebo (look-alike medicine with no active ingredient). At 6 weeks and 12 weeks into~     the study, they return to the NIH Clinical Center for evaluation of their sensitivity to pain~     and level of physical capability. After 12 weeks, study subjects cross-over their~     medication; that is, patients who took neurotropin for the first 12 weeks of the study take~     placebo for the next 12 weeks, and vice-versa. Again, after 6 and 12 weeks, patients return~     for evaluation.~      Participants have blood and urine tests six times during the study and complete~     questionnaires each week about their pain, symptoms, and activities.~   "
243544|NCT00366522|"~     To evaluate the safety and tolerability of a single dose of LXR-623 in healthy subjects.~   "
243545|NCT00366509|"~     This study will examine bacteria and toxins in the mouth, lung and digestive system that may~     be the cause of various diseases or symptoms. H. pylori is a bacterium that produces various~     toxins that may contribute to lung problems. This study will examine specimens collected from~     the mouth, teeth, lung, digestive tract and blood to measure H. pylori and its toxins and~     their effects on cells.~      People 18 years of age and older with or without gastrointestinal disease may be eligible for~     this study. These include people without a history of lung disease as well as patients with~     any of the following: lymphangioleiomyomatosis, asthma, sarcoidosis, other chronic or genetic~     lung disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis or eosinophilic~     granuloma).~      Participants may undergo the following tests:~        -  Blood and urine tests, chest x-ray.~        -  Measurement of arterial blood gases: A small needle is placed in an artery in the~          forearm to collect arterial blood.~        -  Lung function tests: Subjects breathe deeply and occasionally hold their breath. They~          may also receive a medication that expands the airways.~        -  Fiberoptic bronchoscopy with lavage and bronchial brushing: The subject's mouth and~          throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible~          tube called a bronchoscope is advanced through the nose or mouth into the lung airways~          to examine the airways. Saline (salt water) is then injected through the bronchoscope~          into the air passage and then removed by gentle suction. Next, a small brush is passed~          through the bronchoscope and an area of the airway is brushed to collect some cells for~          examination.~        -  Mouth rinsing or teeth brushing to collect cells.~        -  Endoscopy: A small needle and catheter (thin plastic tube) are placed into an arm vein~          to administer fluids and medications through the vein. A sedative may be given. The~          throat is numbed with lidocaine and a thin flexible tube called an endoscope is inserted~          through the mouth and down the esophagus into the stomach and upper part of the small~          intestine to examine those areas.~   "
243546|NCT00366496|"~     To determine quality of vision post cataract extraction and intraocular lens (IOL)~     implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and~     Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes,~     wavefront, corneal topography, and patient satisfaction.~   "
243548|NCT00366470|"~     There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB~     when given in addition to normal TB therapy. This needs to be proven with a controlled~     clinical trial. People receiving Vitamin D with anti TB therapy will be compared against~     people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery~     (as shown by a quicker sputum culture conversion).~   "
243549|NCT00366457|"~     The main purpose of this study is to learn whether or not the combination of gemcitabine,~     bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic~     cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop~     cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved~     by the FDA for the treatment of colorectal cancer but is still considered investigational for~     treating pancreatic cancer.~   "
243550|NCT00366444|"~     A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain~     following bunionectomy surgery.~   "
243551|NCT00366431|"~     The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of~     MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic~     non-malignant pain.~   "
243552|NCT00366418|"~     This study will test the safety and effectiveness of using lower-dose rituximab given more~     frequently for treating chronic lymphocytic leukemia (CLL). Studies have shown that, used~     once a week for 4 weeks, rituximab was effective in up to 25 percent of patients with CLL.~     New evidence shows that using lower and more frequent doses of rituximab can be more~     effective in destroying leukemia cells and produce a better treatment response.~      Patients 21 years of age and older with CLL who have received treatment with fludarabine may~     be eligible for this study.~      Participants take rituximab for 12 weeks. One dose of the drug is infused through an arm vein~     over about 30 minutes on either day 1 (the first dose) or day 3 (the second dose). All other~     doses are given as an injection under the skin. After the first week, patients can choose to~     do these injections at home. Rituximab will be given 3 times a week for a total of 12 weeks.~     Other medications are given to reduce the side effects and allergic reactions to the drug. In~     addition to treatment, patients undergo the following tests and procedures:~      Before treatment~        -  Medical history, physical examination, electrocardiogram (EKG) and blood tests.~        -  Bone marrow and lymph node biopsies (surgical removal of a small tissue sample).~        -  Computed tomography (CT) and positron emission tomography (PET) scans. CT uses special~          x-rays to provide images of the neck, chest, abdomen and pelvis. PET uses a radioactive~          sugar to identify areas of disease.~      During treatment (study weeks 1-12)~        -  Medical history and physical examinations at weeks 3, 6 and 12 to evaluate drug side~          effects, plus weekly telephone checks and interim visits when needed.~        -  Blood tests every other week to evaluate blood counts.~      Evaluations after treatment (follow-up 3 months to 12 months)~        -  Blood tests at follow-up visits at 3, 6, 9 and 12 months after treatment to evaluate~          blood counts.~        -  Bone marrow aspiration and biopsy at 3 months after treatment to examine the effects of~          rituximab on bone marrow cells.~        -  CT scans of the neck, chest, abdomen and pelvis at 3, 6, 9 and 12 months after treatment~          to evaluate the response to treatment.~   "
243553|NCT00366405|"~     The purpose of this study is to evaluate the visual outcomes, amount of inflammation,~     endothelial cell loss, and the efficiency of a torsional handpiece compared to a conventional~     handpiece during surgery to remove your cataracts.~   "
243554|NCT00366392|"~     The purpose of Project Magnify is to determine which of the two current strategies (large~     print versus optical aids) for helping visually impaired students improve their reading~     abilities works better. Our hypothesis is that optical aids work better than providing the~     student with large print materials. Since large print materials are of one size only, and the~     level of visual impairments among students varies greatly, it seems apparent that large print~     materials will work well for some students, but not for all. An optical aid designed for each~     individual student's level of impairment seems to hold more promise in helping each student~     reach their maximum level of performance. Although Project Magnify is designed to increase~     reading abilities, it is expected that students will also develop greater independence and~     confidence in home and community activities that require the use of vision.~   "
243555|NCT00366379|"~     This study will assess the efficacy, safety and tolerability of increasing doses of GK~     Activator (2) in patients with type 2 diabetes whose condition has not been optimally~     controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their~     previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for~     12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a~     target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is~     <3 months, and the target sample size is 100-500 individuals.~   "
243556|NCT00366366|"~     This study assessed the immunogenicity and safety of two vaccination regimens that employed~     either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two~     groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2~     doses of the primary vaccination course. At 5 months of age, they received either the~     DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib~     vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV~     vaccine at birth and at 1 month of age.~   "
243557|NCT00366353|"~     An important part of how we decide when a patient is ready to have their breathing tube~     removed is to have a person breathe without any machine breaths while the breathing tube is~     still in place. We call this a spontaneous breathing trial.~      Commonly, while patients have the breathing tube, they are given medications to keep them~     sedated and comfortable so breathing does not bother them. These medicines are often stopped~     before the spontaneous breathing trial so they can be more awake for the test.~      There are signs the doctors look for during the spontaneous breathing trial that suggest the~     patient might not be ready for the breathing trial to come out. Signs like fast breathing,~     small breaths, a fast heart rate, or looking more anxious than usual may mean that the~     patient is not ready to come off the ventilator. However, if someone has been given sedation~     medicines the entire time they have had a breathing tube and are then woken up, they may~     naturally get very anxious. They may show the same signs as someone who is failing their~     breathing test, but in their case these signs are only because they are anxious.Doctors may~     mistake these signs as failing the breathing test and may not pull the breathing tube out~     even though the patient is really ready for it to come out.~      We wish to try and find out if patients do better during their spontaneous breathing trials~     if they are continued on some sedative medicines to treat anxiety or if they do better if the~     medicines are stopped before the test.~   "
243558|NCT00366340|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of a~     13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate~     (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months~     (infant series) and at 11-12 months of age (toddler dose) in Germany.~   "
243559|NCT00366327|"~     An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to~     evaluate long-term safety.~   "
243560|NCT00366314|"~     The purpose of this study is to quantify and analyze the line accesses for each of the 3~     participating ICUs.~      The hypothesis is that the CICU will have a significantly higher number of line accesses than~     the other units. Analyzing the data will assist the researchers in identifying best practices~     and ultimately, reduce the BSI rate in the CICU.~   "
243561|NCT00366301|"~     The purpose of this study, which is being conducted at 100 centers throughout the United~     States, is to determine whether Lantus, a long-acting insulin injection, either alone or in~     combination with metformin, is effective in reducing C-reactive protein (CRP) in adults with~     type 2 diabetes. CRP is a marker of chronic low-level inflammation, a new risk factor for~     diabetes, heart attack, stroke, and other cardiovascular events.~   "
243562|NCT00366288|"~     This study is to evaluate the safety and tolerability of single, ascending doses of PAZ-417~     in healthy young and healthy elderly subjects. The effect of a high fat meal on the~     metabolism of PAZ-417 will also be studied, along with blood levels of PAZ-417 . Changes in~     cognitive function will be assessed.~   "
243563|NCT00366275|"~     The purpose of this study is to determine the rate and duration of complete remission and~     molecular response in patients with relapsed/refractory follicular lymphoma, using a combined~     treatment with rituximab plus chemotherapy followed by in vivo purged peripheral blood stem~     cells (PBSC) mobilization and autotransplant.~   "
243564|NCT00366262|"~     The purpose of this study is to provide an initial assessment of the gastrointestinal safety~     of a 7-day regimen of PLA-695 compared to placebo or naproxen.~   "
243565|NCT00366249|"~     The purpose of this study was to look at the safety and effectiveness of a once-daily dose of~     tigecycline compared to ertapenem for the treatment of diabetic foot infections. The~     co-primary efficacy endpoints were not met.~   "
243566|NCT00366236|"~     The purpose of this study is to determine the effect of nitazoxanide tablets in treating~     diarrhea caused by Entamoeba histolytica in adults and adolescents.~   "
243567|NCT00366223|"~     The purpose of this study is to determine the changing patterns of infection caused by~     Candida species in urban medical centers and its influence on patient outcomes. A~     retrospective cohort study design will be employed with the main outcome measure being~     hospital mortality. Secondary outcomes including microbiologic clearance of the infection,~     duration of hospitalization, and the intensive care unit (ICU) length of stay will also be~     assessed.~   "
243568|NCT00366210|"~     The purpose of this study is to compare modified CI therapy for strokes survivors with very~     limited function to an alternative package of conventional physical rehabilitation techniques~   "
243569|NCT00366197|"~     This trial examines weaning outcomes using the rapid shallow breathing index rate.~   "
243570|NCT00366184|"~     This study will examine whether transcranial magnetic stimulation (TMS) of the brain used in~     combination with carbidopa-levodopa is more effective in temporarily improving the speed of~     hand movement in stoke patients than TMS alone. In TMS, a wire coil is held on the patient's~     scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that~     stimulates the brain. The effect of TMS on the muscles is detected with small metal disk~     electrodes taped to the skin of the arms or legs. Carbidopa-levodopa is a medication usually~     used to treat Parkinson's disease, but it may improve the effect of theta burst stimulation.~      Two kinds of TMS are used in this study. In single-pulse TMS one or two pulses are delivered~     at a time in order to measure brain activity at that moment. In repetitive TMS (rTMS), a~     series of pulses are given in short bursts, temporarily altering brain activity. The type of~     rTMS used in this study is called theta burst stimulation.~      Healthy normal volunteers and people who had a stroke 6 months or more before entering the~     study may be eligible to participate. All candidates must be between 18 and 90 years of age.~     Stroke patients must have had significant hand weakness and made a moderate or good recovery~     and must be able to move either the thumb or the wrist on the affected hand reasonably well.~     Normal volunteers must be right-handed.~      Participants complete the testing for this study in four main sessions scheduled at least a~     week apart and five short follow-up sessions. At each main session, participants take either~     a carbidopa-levodopa tablet or a placebo (a look-alike inactive substance). Stroke patients~     have their arm and hand function assessed using two tests. One requires them to insert pegs~     into holes; the other includes writing, lifting various objects, and performing activities~     like turning pages, feeding or stacking checkers.~      All subjects complete a questionnaire regarding their mood and alertness and then perform~     tests of thumb or wrist movement. For this test, a small electrical stimulus is applied to~     the side of the hand and the subject must respond to the stimulus as quickly as possible by~     making a thumb or wrist movement. This is repeated several times over about 3 minutes. A~     second test follows in which the subject moves the thumb or wrist in response to a beep from~     a speaker. This test is repeated several times over about 8 minutes. Some measurements are~     taken using single-pulse TMS during the beginning, middle and end of this test. In two of the~     four sessions, theta burst stimulation is applied after the single-pulse TMS and in the other~     two sessions, sham theta burst stimulation is applied.~      Five follow-up sessions are scheduled one day after each main session and one week following~     the final one. In these sessions, subjects perform an abbreviated form of the thumb movement~     tests.~   "
243571|NCT00366171|"~     A one year extension study using flexible doses, 20 or 30 mg daily, of open-label bifeprunox.~   "
243572|NCT00366158|"~     The primary efficacy objective of this clinical investigation is to demonstrate that the~     Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term~     incidence of unnecessary ventricular pacing in patients with intact AV conduction.~   "
243573|NCT00366145|"~     The purpose of this study is to evaluate the efficacy and gather additional safety of~     Prochymal in subjects who have failed to respond to steroid treatment of Grades B-D acute~     GVHD.~   "
243574|NCT00366132|"~     The purpose of this clinical study is to compare the safety and effectiveness of shockwave~     treatment combined with standard-of-care treatment, to standard-of-care treatment alone to~     induce healing of a chronic plantar foot ulcer in subjects with diabetes mellitus. For the~     purpose of this study, the definition of plantar foot ulcer is a wound or open sore that~     involves the plantar(bottom) aspect of the foot, and the definition of chronic is a duration~     of 6 weeks or greater with a lack of response to treatment.~   "
243575|NCT00366119|"~     The purpose of this study is to assess which drug is more effective of Ramiprin®(ramipril)~     and Tritace®(ramipril) in the Treatment of Essential Hypertension~   "
243576|NCT00366106|"~     The current study is being conducted to evaluate the possibility that a different schedule of~     bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of~     peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib~     dosing for a longer period.~   "
243577|NCT00366093|"~     To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or~     menopause following treatment with 3 mg of eszopiclone.~   "
243578|NCT00366080|"~     The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in~     treating patients with narcolepsy.~   "
243579|NCT00366067|"~     The purpose of this study was to determine whether antiepileptic drug phenytoin is effective~     in the treatment of chronic asthma in children.~   "
243580|NCT00366041|"~     After severe burn injury, the full-thickness burn areas are excised (in the first week) and~     then temporarily covered with allograft (cryogenic preserved cadaver skin). This first~     covering is then replaced with thin skin meshed autograft.~      In this study, either the dermal substrates cellularised LG002 or uncellularised LG002 will~     be grafted, after excision, in symmetrical areas, in replacement of the allografts. Fourteen~     to twenty one days after this first covering, the dermal substrate will be covered with thin~     skin meshed autograft.~   "
243581|NCT00366028|"~     Evidence-based clinical practices (EBCPs) are often not widely adopted, despite extensive~     efforts to influence individual practitioners to use them. The aim of the project is to work~     with Veterans Integrated Service Networks (VISN) 1, 10, and 23 and their medical centers to~     create and test organizations that facilitate the use of EBCPs. The research objectives are~     to: Test the effectiveness of the proposed organizational model in comparison with a more~     limited data-feedback strategy in improving system use of a selected EBCP; Identify and~     analyze organizational factors that affect model implementation; Test the feasibility of~     intervention activities to introduce and support the model.~   "
243582|NCT00366015|"~     This study will combine coronary stenting with minimally invasive robotic coronary bypass~     surgery, accomplished with the use of the da Vinci robot, to restore blood flow to occluded~     coronary arteries. Two previously approved and commonly performed procedures used to treat~     coronary artery disease(coronary stenting and robotic bypass surgery) are being combined into~     a hybrid surgery in a specialty built operating room. Patients with low risk coronary lesions~     will undergo cardiac hybrid revascularization using stenting and LIMA to LAD robotic bypass~     concomitantly. Patients' postoperative bleeding rates, angiographs and complication free~     rates will be recorded.~   "
243583|NCT00366002|"~     This study will evaluate safety, efficacy and patient's perception of outcome after treatment~     with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in~     patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or~     tolterodine extended release (ER) therapy.~   "
243584|NCT00365989|"~     This is a phase 3 study to determine the safety of the new features to the FDA approved~     ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.~   "
243585|NCT00365976|"~     The purpose of this study is to examine whether insomnia due to chronic low back pain can~     improve with use of eszopiclone.~   "
243586|NCT00365963|"~     The purpose of this study is to find out if patients with lung cancer and their main informal~     caregiver (person providing physical, emotional, or financial support) are helped by getting~     information, support, and decision making tools through a computer system called CHESS(the~     Comprehensive Health Enhancement Support System)~   "
243587|NCT00365950|"~     To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the~     treatment of DVT/PE~   "
243588|NCT00365937|"~     Open-label single center study. Patients will be divided in four groups of 7. Group 1: 8~     melanoma-specific peptides in saline; Group 2: same mix of peptides + Montanide ISA51; Group~     3: same mix of peptides + IMP321 500 µg; Group 4: same mix of peptides + IMP321 500 µg +~     Montanide ISA51. These vaccines will be administered every 3 weeks on 5 occasions by~     intradermal and superficial subcutaneous injections.~   "
243589|NCT00365924|"~     This methodology trial will be conducted in patients with osteoporosis and will measure the~     changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone~     density following therapy with the approved drug, Forteo.~   "
243590|NCT00365911|"~     Blood sample is taken for measurement of serum creatinine, cystatin C, clone V haemoglobin,~     cholesterol, urine acid, glycemia and CRP.~      The medical file is gathered. There will be searched for an association between renal~     function and cardiovascular risk factors and risk factors by exposition to toxic substantia~     during work.~   "
243591|NCT00365898|"~     The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone~     Hydrochloride Extended-Release.~   "
243592|NCT00365885|"~     The purpose of this study is to determine the value of shared health information on care~     quality and costs when this information is used to notify care providers about concerning~     health events for patients cared for by a community-based network of providers.~   "
243593|NCT00365872|"~     This is a Phase II study using a combination of external beam radiation with intratumoral~     injection of dendritic cells (white blood cells) as neo-adjuvant treatment for patients with~     high-risk soft tissue sarcoma. The purpose was to determine if an injection of the patient's~     own immune related white blood cells into their tumor would strengthen the immune system to~     fight against their cancer.~   "
243594|NCT00365859|"~     This study will provide long-term safety data for patients who are taking aripiprazole for up~     to 1 year. Most patients enrolled in this study will have participated in a short-term study~     with aripiprazole (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]).~   "
243595|NCT00365846|"~     The purpose of the study is to see if campath-1H can be used in first time renal transplant~     subjects to prevent rejection and reduce the overall amount of anti-rejection medications~     that patients take on a daily basis.~   "
243596|NCT00365833|"~     We believe that certain cells in the human body (Circulating Endothelial Cells and~     Endothelial Progenitor Cells) are related to risk of cardiovascular disease. It may be~     possible to measure levels of these cells in patients who have had a kidney transplant and~     predict their risk of developing cardiovascular disease.~   "
243597|NCT00365820|"~     This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation~     in patients with non-cancer pain.~   "
243598|NCT00365807|"~     The current study examined the effectiveness of a behaviorally-based group intervention for~     overweight children and their families. The target intervention was compared to an enhanced~     standard of care treatment. The impact of both treatment programs on numerous outcomes was~     explored.~   "
243641|NCT00365235|"~     Familial combined hyperlipidemia (FCHL) is an inherited disorder characterized by elevated~     levels of cholesterol and triglycerides; it often occurs in Mexican individuals with coronary~     heart disease (CHD). The purpose of this study is to identify the specific genes that~     predispose Mexican individuals to FCHL.~   "
243853|NCT00362401|"~     The purpose of this study is to compare the sound pressure levels (SPLs) from three of the~     most frequently implanted mechanical heart valve prostheses, in order to determine whether~     there was any significant difference between the intensities of the valve sounds~   "
243599|NCT00365794|"~     A. HYPOTHESES: In older men low testosterone levels, abdominal obesity and elevated fasting~     insulin who are at risk for the cardiovascular complications such as heart attack and stroke.~        1. Supplemental testosterone will decrease abdominal fat (visceral adominal adipose tissues~          (VAT), subcutaneous abdominal adipose tissue (SAT), and hepatic fat) and~          intramyocellular lipid in peripheral muscles(IMCL).~        2. Supplemental testosterone will improve insulin sensitivity by:~             1. Decreasing hepatic glucose output (HGO), a measure of central insulin resistance~             2. Decreasing VAT~             3. Decreasing SAT~             4. Increasing adiponectin production~             5. Improving peripheral glucose disposal (Rd) by reducing IMCL~             6. Increasing appendicular skeletal muscle mass and basal metabolic rate~      B. OBJECTIVES:~        1. Primary Objective: To determine the effects of supplemental testosterone to achieve~          testosterone levels in the upper normal physiologic range on central adipose tissue~          (abdominal VAT, SAT, and hepatic fat) and peripheral skeletal muscle fat (IMCL and~          intermyocellular fat).~        2. Secondary Objectives: To determine the effects of supplemental testosterone to achieve~          testosterone levels in the upper normal physiologic range:~             1. on hepatic glucose output (HGO) and peripheral glucose disposal (Rd)~             2. on hepatic glucose synthesis from glycogen, glycerol and the Krebs cycle using~               [1,6-13C2C] glucose, D2O, and [U-13C3] palmitate isotope dilution studies~             3. on adiponectin and apoprotein B levels~             4. on basal metabolic rate (REE, R/Q) as related to changes in skeletal muscle mass~      Results of this study will provide greater understanding whether androgen therapy enhances~     insulin sensitivity by decreasing HGO, decreasing adiponectin production, improving~     peripheral Rd and if these desired effects are achieved, whether they are due to reductions~     in VAT, SAT, liver fat, IMCL or effects of augmenting muscle mass per se. Results will~     generate hypotheses to investigate cellular and molecular mechanisms of androgen effects in~     persons at risk for the Metabolic Syndrome.~   "
243600|NCT00365781|"~     10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS~     113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a~     5-minute period. On Study Days 2 and 8, each subject's injection sites will be assessed for~     dermatologic effects. The Isis Project Physician(s) will observe the injection sites on Study~     Day 2 and may also observe on Study Day 8.~      Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Day 1~     and Day 8. Subjects will be contacted by telephone on Study Day 30 to monitor for the~     occurrence of new serious adverse events (SAEs). Thereafter, the subjects will be discharged~     from the study.~   "
243601|NCT00365768|"~     RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known~     whether glutamine is more effective than a placebo in treating neuropathy caused by~     vincristine.~      PURPOSE: This randomized phase II trial is studying glutamine to see how well it works~     compared to a placebo in treating neuropathy caused by vincristine in young patients with~     lymphoma, leukemia, or solid tumors.~   "
243602|NCT00365755|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed. A bone marrow transplant, using bone marrow from the patient, may be able to~     replace blood-forming cells that were destroyed by chemotherapy. It is not yet know which~     combination chemotherapy schedule is more effective, when given before surgery and an~     autologous bone marrow transplant, in treating patients with disseminated neuroblastoma.~      PURPOSE: This randomized phase III trial is studying two different chemotherapy schedules to~     compare how well they work in treating young patients who are undergoing surgery and an~     autologous bone marrow transplant for disseminated neuroblastoma.~   "
243603|NCT00365742|"~     Randomized trial in a primary prevention population~        -  all participants have high LDL cholesterol~      Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle~     changes,and take supplements consisting of red yeast rice and fish oil~   "
243604|NCT00365729|"~     Human papillomavirus (HPV)-infection belongs to the most common sexually transmitted diseases~     worldwide. HIV-infected men having sex with men (MSM) are strongly associated with a higher~     prevalence of genital HPV-infection, a higher incidence of anal intraepithelial neoplasia~     (AIN), and, consecutively, an increased risk for anal cancer. Since the introduction of~     highly active antiretroviral therapy (HAART), the incidence of several viral-associated~     neoplasias has significantly fallen in HIV-infected individuals. At the beginning of the era~     of HAART, a justified hope existed that genitoanal HPV-related neoplasias would also decrease~     based on the success of HAART-induced immune restoration. However, HAART seems to have only a~     small impact on the natural history of AIN as observed in a cohort of HIV-positive MSM before~     and after the initiation of HAART.~      As AIN and cancer precursor lesions of the cervix, cervical intraepithelial neoplasia, share~     distinct clinical similarities, cytologic smear testing for AIN has been recommended to~     detect and treat early lesions. Thus, this prospective study mainly focuses on the predictive~     value of HPV-DNA load for the development and clinical progression of AIN in HIV-infected~     MSM. Moreover, the course of HPV viral load under therapy for anal intraepithelial neoplasia,~     e.g. topical treatment with imiquimod, will be evaluated. Additionally, immunohistochemical~     determination of several proliferative biomarkers, as well as cytokines, will be performed.~   "
243605|NCT00365716|"~     This study was conducted in 2 parts. Part A was a randomized, double-blind,~     placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a~     randomized, double-blind (operating under in-house blinding procedures), placebo-controlled,~     multicenter, dose-ranging study.~   "
243606|NCT00365703|"~     The purpose of this study is to find out which method (nasogastric vs. orogastric) of feeding~     tube for premature infants results in earlier only oral feeding.~   "
243607|NCT00365690|"~     This study will evaluate the effectiveness of a telephone-delivered coping improvement group~     intervention in improving quality of life in older adults with HIV.~   "
243608|NCT00365677|"~     The objective of this study was to compare the safety and effectiveness of two versions of~     the Bausch & Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue~     Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.~   "
243609|NCT00365651|"~     This study will examine whether two months of youth soccer, combined with a single brief~     behavioral/nutritional intervention, can reduce BMI in 5th grade overweight or obese females.~   "
243610|NCT00365638|"~     The purpose of this study is to determine whether statins (simvastatin) improve clinical~     (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of~     systemic inflammation) in women with polycystic ovary syndrome (PCOS).~   "
243656|NCT00365014|"~     The purpose of this study is to identify and characterize blood diseases presenting at~     Shanghai hospitals and to compare them with respect to clinical presentation, phenotype,~     molecular characteristics, benzene or other exposures and genetic susceptibility.~   "
243854|NCT00362388|"~     This study was designed to test the hypothesis that direct injection of bone-marrow cells in~     the heart may increase the number of blood vessels, ameliorating the heart's performance, and~     relieving patients from symptoms like angina and/or shortness of breath.~   "
243611|NCT00365625|"~     The stepwise process of leukocyte extravasation to inflamed tissues depends on the expression~     of a variety of cytokines and adhesion molecules. Recently much attention has focused on the~     Junctional Adhesion Molecules (JAM). The three members of this adhesion molecule family,~     namely, JAM-A, -B and -C, have been shown to govern the last step of leukocyte extravasation~     (transmigration) - the process of leukocytes passing between endothelial cells. In addition~     to transmigration, some members of this family seem to support additional steps in the~     leukocyte extravasation cascade. The investigators recently showed, that antibody-mediated~     inhibition of JAM-C significantly reduced hapten induced skin inflammation (J Invest~     Dermatol;125(5):969).~      Recent unpublished work from our laboratory showed, that JAM-C expression of lymphocytes can~     be up-regulated through specific activators. Hence, the investigators hypothesize, that JAM-C~     expression is elevated in patients with psoriasis. As it is currently not know, which factors~     may influence the expression of JAM-C, the investigators intend to analyse JAM-C expression~     on CD3+CD41- cells at several time-points during the treatment of psoriatic patients.~     Expression of JAM-C will then be correlated to disease activity (PASI).~   "
243612|NCT00365612|"~     To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of~     efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured~     by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.~   "
243613|NCT00365599|"~     Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.~   "
243614|NCT00365586|"~     The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain~     associated with Osteoarthritis Flare of the Knee.~   "
243615|NCT00365573|"~     The purpose of this study is to evaluate the blood supply to patients that are suffering from~     fracture in the tibia by UltraSound Doppler.~   "
243616|NCT00365560|"~     The primary objective of this study is to examine efficacy and safety of tiotropium compared~     to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification~   "
243617|NCT00365547|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as Avastin (bevacizumab), can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Giving topotecan together with~     bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving topotecan together with bevacizumab~     works in treating patients with stage IIIB or stage IV non-small cell lung cancer that did~     not respond to previous systemic chemotherapy.~   "
243618|NCT00365534|"~     The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and~     regular colonoscopy by MEI.~   "
243619|NCT00365521|"~     To evaluate a possible prophylactic efficacy of photodynamic therapy on the incidence of~     non-melanoma skin cancer, actinic keratoses, warts and keratoses in recently organ~     transplanted recipients.~   "
243620|NCT00365508|"~     RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may~     help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is~     more effective than counseling and the nicotine patch in helping adult smokers quit smoking.~      PURPOSE: This randomized phase III trial is studying counseling and the nicotine lozenge to~     see how well they work compared to counseling and the nicotine patch in helping smokers quit~     smoking.~   "
243621|NCT00365495|"~     Physical activity as treatment for patients with type 2 diabetes (T2D). Treatment of T2D is~     often done by medication, changing the diet and increased physical activity. It is well~     established that physical training has a positive effect on the pathology of T2D such as~     increased insulin sensitivity and reduced fasting plasma glucose (7) and blood lipids (15).~     It is also well known that in healthy subjects endurance training increases mitochondrial~     density, lipid oxidation during submaximal exercise, and results in a number of qualitative~     changes in the control of OXPHOS (24). However, the effect of physical training on the~     mitochondrial function in skeletal muscle of patients with T2D has not been investigated.~      The purpose of this project is to investigate the effect of physical training on the~     mitochondrial respiratory function in muscles of patients with T2D. Skeletal muscle biopsies~     will be taken before and after 10 weeks of physical training in patients with T2D and matched~     control subjects. Mitochondria will be isolated from the muscle biopsies, and respiratory~     function, free radical production and UCP3 will be determined. Furthermore, measures of~     maximal oxygen consumption (VO2max), heart rate and capillary lactate concentrations and~     carbohydrate and lipid oxidation will be determined partly to verify an increased aerobic~     capacity and partly to investigate the changes in these factors in T2D patients.~   "
243622|NCT00365482|"~     The purpose of this study is to find out how often major mood swings occur in patients~     treated in a specialty epilepsy center.~   "
243623|NCT00365469|"~     The investigators had conducted a double-blind, randomized placebo-controlled clinical trial~     studying the effects of 6 months probiotics supplementation from birth on allergic disease~     and sensitization up to 2 years of age. This follow-up study will extend a further 3 years to~     5 years of age for assessing the longer term beneficial effects of this form of probiotics~     intervention on the incidence of allergic disease and sensitization at 5 years of age.~   "
243624|NCT00365456|"~     The objective is to show superior efficacy of PTH (1-84) over risedronate in treating~     osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12~     months followed by 12 months treatment with risedronate.~   "
243625|NCT00365443|"~     This study is to evaluate an investigational vaccine with the following objectives: (1) To~     demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers,~     external genital lesions, and persistent infection caused by the HPV types in the study~     vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate~     vaccine immune responses in women.~      This is an early phase trial and some specific protocol information is proprietary and not~     publicly available at this time. (Full information is available to trial participants).~   "
243626|NCT00365430|"~     The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program~     for the prevention of three frequently occuring adverse events: pressure ulcers, urinary~     tract infections and falls.~   "
243627|NCT00365417|"~     Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation~     in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs~     kill cancer cells more directly. This study will evaluate:~        -  How bevacizumab, given with chemotherapy before surgery, and then bevacizumab given~          alone after surgery, will affect locally advanced breast tumors~        -  Side effects from adding bevacizumab to chemotherapy~        -  Whether adding bevacizumab to chemotherapy for breast cancer will affect the heart~        -  If receiving bevacizumab will have any effect on how patients recover from surgery~        -  Side effects of the combinations of drugs used in this study~   "
243628|NCT00365404|"~     The purpose of the study was to implement well-developed guidelines for arthritis management~     beyond acute medical management to independent community living by modifying existing weight~     management and physical activity promotion programs for people with disabling arthritis.~      Our hypotheses were:~        1. Existing individual, health care system, and community strategies to promote physical~          activity and weight management can effectively be modified and expanded to include those~          with debilitating joint diseases.~        2. People with inflammatory joint disease can have healthy physical activity levels and~          weight at home and in the community.~        3. The effect of these interventions will be higher quality of life, lower depression~          rates, modest pain levels, and functional independence.~   "
243629|NCT00365391|"~     This phase II trial is studying how well giving bevacizumab together with erlotinib works in~     treating patients with advanced liver cancer. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Bevacizumab and erlotinib may also stop the growth of tumor cells by blocking blood~     flow to the tumor. Giving bevacizumab together with erlotinib may kill more tumor cells~   "
243630|NCT00365378|"~     Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy,~     immunogenicity, and safety.~   "
243631|NCT00365365|"~     This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study~     designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab~     administered with three different docetaxel-based combination regimens for the adjuvant~     treatment of participants with node positive or high-risk node negative breast cancer.~   "
243632|NCT00365352|"~     The primary objective of this trial is to assess the efficacy of XP13512 taken once daily~     compared to placebo for the treatment of patients suffering from Restless Legs Syndrome~     (RLS).~   "
243633|NCT00365339|"~     The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir,~     identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with~     famotidine results in atazanavir exposures similar to those when~     atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy~     subjects.~   "
243634|NCT00365326|"~     This phase I clinical trial will evaluate the safety and efficacy of intra-coronary injection~     of AC133 selected autologous marrow-derived stem cells in patients with chronic coronary~     artery occlusion. A clinical study to determine the therapeutic potential of marrow-derived~     stem cells as an adjunct therapy to current standard therapies for CAD is warranted. The~     current initiative is to investigate a model of chronic myocardial ischemia and (1) to~     determine whether intra-coronary injection of selected autologous marrow-derived AC133 stem~     cells is reasonably safe for use in humans and (2) if this treatment shows any improvement in~     coronary perfusion, as assessed using non-invasive imaging. This study is structured to~     evaluate the feasibility and safety of autologous AC133+ bone marrow-derived stem cell via~     intra-coronary injection into documented ischemic but viable myocardial zones via established~     collateral vessels. The epicardial vessel that normally supplies the ischemic zone must be~     100% chronically occluded and considered non-revascularizable by percutaneous means.~   "
243635|NCT00365313|"~     The purpose of this study is to compare the effect of Esomeparzole with Placebo in the~     Prevention of Recurrent Ulcer Bleeding in Patients Receiving a COX-2 Inhibitor~   "
243636|NCT00365300|"~     To assess the efficacy of pantoprazole for the treatment of infants with symptomatic~     Gastroesophageal Reflux Disease (GERD).~   "
243637|NCT00365287|"~     RATIONALE: Giving low doses of chemotherapy and radiation therapy before a donor umbilical~     cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the~     patient's immune system from rejecting the donor's stem cells when they do not exactly match~     the patient's blood. The donated stem cells may replace the patient's immune system and help~     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after~     transplant may stop this from happening.~      PURPOSE: This phase I/II trial is studying the side effects of giving combination~     chemotherapy together with total-body irradiation before donor umbilical cord blood~     transplant and to see how well they work in treating patients with advanced hematologic~     cancer, metastatic breast cancer, or kidney cancer.~   "
243638|NCT00365274|"~     This phase II trial is studying how well giving SGN-30 together with combination chemotherapy~     works in treating patients with newly diagnosed anaplastic large cell lymphoma. Monoclonal~     antibodies, such as SGN-30, can block cancer growth in different ways. Some block the ability~     of cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving SGN-30 together with combination chemotherapy may kill more cancer cells~   "
243639|NCT00365261|"~     To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and~     who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:~        -  improve sleep thereby decreasing need for opiates via PCA~        -  improve sleep thereby decreasing pain by self report~        -  improve sleep thereby decreasing fatigue by self report~   "
243640|NCT00365248|"~     The overall objective is to assess the haemostatic efficacy and safety of TachoSil for~     control of local bleeding in paediatric patients undergoing surgical resection of the liver~     with our without segmental liver transplantation.~   "
243642|NCT00365222|"~     A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed~     glioblastoma in elderly patients (defined as greater than or equal to 70 years old).~     Following surgical resection, and confirmation of glioblastoma, patients will proceed to~     primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on~     and 14 days off occurring every 56 days.~      Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History,~     Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality~     Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast.~      The same procedures are repeated on Day 1 of each treatment cycle with the addition of an~     adverse event assessment. And the off study procedures for patients are performance status,~     Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.~      Patients may continue with each temodar daily dose therapy if clinical and~     neuroradiographical exams are stable or improving.~   "
243643|NCT00365209|"~     Chemoprevention is the use of certain substances to keep cancer from forming, growing, or~     coming back. Curcumin is a compound found in plants that may prevent colon cancer from~     forming. This phase II trial is studying how well curcumin works in preventing colon cancer~     in smokers with aberrant crypt foci.~   "
243644|NCT00365196|"~     Individuals who experience high hostility levels may be more prone to developing coronary~     artery disease (CAD) than individuals who experience low hostility levels. This study will~     evaluate the effectiveness of a hostility reduction treatment program on the body's ability~     to regulate heart activity in individuals with high levels of hostility.~   "
243645|NCT00365183|"~     The goals of this study are:~        -  to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may~          be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have~          had one previous chemotherapy regimen that included a platinum containing drug such as~          cisplatin or carboplatin.~        -  to assess response to treatment in patients with NSCLC six months after beginning study~          treatment.~   "
243646|NCT00365170|"~     This trial was conducted in Europe, Middle East, North America and South America.~      The aim of this trial was to compare the use of an intensified insulin treatment with insulin~     aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.~   "
243647|NCT00365157|"~     This phase I/II trial studies the side effects and best dose of eribulin mesylate and to see~     how well it works in treating patients with cancer of the urothelium that has spread to~     nearby tissue or to other places in the body and kidney dysfunction. Drugs used in~     chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Chemotherapy drugs may have different effects in patients who have changes in~     their kidney function.~   "
243648|NCT00365144|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of pancreatic cancer by blocking blood flow to the tumor. Erlotinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     bevacizumab together with erlotinib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib~     works in treating patients with metastatic pancreatic cancer that did not respond to previous~     treatment with gemcitabine.~   "
243649|NCT00365131|"~     This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating~     patients with skeletal manifestations secondary to Type I Gaucher disease.~      The study objective is to evaluate and quantify skeletal responses as compared to baseline in~     Type I gaucher disease patients receiving Cerezyme therapy for 48 months. Additional~     objectives were to assess the usefulness of various skeletal parameters, such as bone pain,~     bone crises, bone mineral density, and serum and urine bone markers, as indicative of~     treatment response and may be useful in dose management.~   "
243650|NCT00365118|"~     The purpose of the trial is to compare efficacy and adverse effects of pulsed dye laser and~     intense pulsed light in patients with port wine stains.~   "
243651|NCT00365105|"~     RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other~     symptoms caused by bone metastases. It is not yet known whether giving zoledronate together~     with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in~     treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer.~      PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to~     see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89~     or samarium 153 in preventing or delaying bone problems in patients with bone metastases from~     prostate cancer, lung cancer, or breast cancer.~   "
243652|NCT00365092|"~     Middle-ear disease (infection and fluid) is the most common illness in young children after~     the common cold. Because hearing loss accompanies middle-ear disease, and because early life~     is a period of rapid development, concern has existed that sustained periods of middle-ear~     disease might cause lasting impairments of learning, speech development, language~     development, or behavior and social adjustment. Earlier phases of this research found that~     the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear~     disease did not affect their development at 3, 4, or 6 years of age. This study examines the~     children's literacy, attention, and related abilities at 9 to 11 years of age.~   "
243653|NCT00365053|"~     This phase II trial is studying how well PXD101 works as second-line therapy in treating~     patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and~     by blocking blood flow to the tumor.~   "
243654|NCT00365040|"~     The present study was designed to compare the use of mitomycin in PRK for the treatment of~     refractive errors and to compare these results to customized Lasik~   "
243655|NCT00365027|"~     It has been suggested that in IVF cycles where GNRH agonist is utilized for final oocyte~     maturation in patients at risk of ovarian hyperstimulation, pregnancy rates are reduced. We~     hypothesize that the use of GNRH antagonist reduces pregnancy rates through an effect on the~     endometrium and not oocyte quality, therefore better results may be obtained by not returning~     these embryos in a fresh cycle but rather cryopreserving them and returning them to the~     uterus and a later stage.~   "
243657|NCT00365001|"~     This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in~     combination with tocilizumab to assess any potential drug interactions. Patients will be~     randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate~     (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and~     43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time~     on study treatment is <3 months, and the target sample size is <100 individuals.~   "
243658|NCT00364988|"~     Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are~     currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or~     in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of~     proteinuria.Whether Combination therapy with pioglitazone and losartan provides additional~     renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.~   "
243659|NCT00364975|"~     Subjects that participate in the practical workshop will improve their metabolic indexes,~     control their weight and improve their quality of life, in contrast to the participants that~     will take part in the nutritional consulting sessions~   "
243660|NCT00364962|"~     Investigate the treatment result of KTP laser nasopharyngectomy in recurrent NPC patients~   "
243661|NCT00364949|"~     Polycystic ovary syndrome (PCOS) is among the most common endocrine disorders in~     premenopausal women, affecting 7-10% of this population. This syndrome is characterized by~     elevated levels of testosterone and chronic anovulation, and frequently of obesity. This~     study is designed to test the hypothesis that there is in utero testosterone excess, altered~     insulin secretion, and/or intrauterine growth retardation in the female offspring of women~     with PCOS. The allele 8 can be used to identify the reproductive and metabolic abnormalities~     associated with PCOS. This study will determine whether allele 8 positive [A8(+)] female~     offspring have more profound changes in these parameters compared to A8(-) female offspring.~      Androgen and insulin levels in amniotic fluid from pregnant women with PCOS will be compared~     to levels in pregnant control women. Androgen and insulin levels in cord blood will also be~     measured. Further, gestational age and anthropomorphic measurements in offspring of women~     with PCOS will be assessed and compared to that in offspring of matched control women.~      We will test the hypothesis that androgens are elevated in infancy in the female offspring of~     women with PCOS. We will assess sex steroids, insulin, and c-peptide levels in infants of~     PCOS women and compare them to the levels in infants of control women up to 1 year of age~     during the minipuberty of infancy. We will determine whether any of these parameters differ~     in A8(+) compared to A8(-) PCOS offspring.~   "
243662|NCT00364936|"~     The primary purpose of this study is to develop, implement and conduct a preliminary~     evaluation of a new service for people who are severely affected by multiple sclerosis. The~     investigators conducted open interviews with patients, families and staff, plus a literature~     review to model and pilot this new service. Then the investigators developed, tested and ran~     the service and will evaluate it using a randomised controlled trial, where people affected~     by MS are randomised to either receive the service immediately (fast track group) or after a~     three month wait (standard best practice). This methodology follows that of the Medical~     Research Council (MRC) framework for the development and evaluation of complex services and~     treatments. The investigators interview people and their carers in the fast track and~     standard practice groups, and followed them over time. This phase of trial enables us to~     calculate sample size and test proof of concept for a full randomised trial. However, our~     working hypothesis was that there would be no difference between those people who received~     the fast track service or the standard best practice in terms of symptom controlled, and~     carer needs.~   "
243663|NCT00364923|"~     Primary~      • Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid~     supplementation when administered to patients with relapsed or refractory peripheral T-cell~     lymphoma (PTCL)~      Secondary~        -  Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid~          supplementation when administered to patients with relapsed or refractory PTCL~        -  Determine the pharmacokinetic (PK) profile of pralatrexate when administered with~          vitamin B12 and folic acid supplementation~   "
243664|NCT00364910|"~     This study will evaluate the safety and efficacy of cognitive behavioral therapy in treating~     people who are experiencing post-traumatic stress disorder after a heart attack.~   "
243665|NCT00364897|"~     Tibial fixation is the weak link when using soft tissue grafts and interference screws for~     fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of~     patients undergoing double loop hamstring autograft ACL reconstruction and compare between~     the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .~   "
243666|NCT00364884|"~     Keto-/amino acid supplemented low protein diet can reduce uremic symptoms, improve~     nutritional status, delay dialysis therapy and enhance health-related quality of life in our~     patients with stage V CKD in comparison to non-supplemented low protein diet.~   "
243667|NCT00364871|"~     The purpose of this study is to determine the efficacy and safety of 3 combinations of~     naltrexone and bupropion SR compared to naltrexone alone, bupropion SR alone or placebo.~   "
243668|NCT00364858|"~     This is a multicenter, randomized trial to compare the safety and efficacy of two dosing~     frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated~     with Cerezyme®.~      Approximately 90 patients will be randomized in a 2:1 (q4 : q2) ratio to one of two treatment~     arms at up to 26 study centers worldwide. Patients will continue to receive the same total~     4-week dose that they were receiving prior to study enrollment, however, they will be~     randomized to receive either their total 4-week dose in two infusions, one infusion every 2~     weeks or their total 4-week dose in one infusion every 4 weeks. The randomization scheme will~     ensure a 2:1 balance between the every 4-week versus every 2-week infusion groups,~     respectively.~   "
243669|NCT00364845|"~     Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety~     follow up phase of 52 weeks~   "
243670|NCT00364832|"~     This study will determine the appropriate dose and frequency of administration of sc Mircera~     maintenance therapy in dialysis patients with chronic renal anemia who were previously~     receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and~     the target sample size is 100-500 individuals.~   "
243671|NCT00364819|"~     The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in~     treating patients with Primary Biliary Cirrhosis (PBC). Rituximab is a laboratory-made~     antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with~     PBC, a disease of the immune system. However, the safety of rituximab in PBC patients must~     first be established.~   "
243672|NCT00364806|"~     Migraine headaches are a common reason for patients to present to an emergency department. We~     are comparing two different medications to see which one is better for patients who present~     ot an emergency room with a migraine headache.~   "
243673|NCT00364793|"~     The primary purpose of this study is to find the dose of Efavirenz for young children. The~     safety and how the medication is tolerated will also be studied.~   "
243674|NCT00364780|"~     The purpose of this phase II study is to determine the safety, tolerability, and activity of~     XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a~     small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2~     (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR~     mutations and associated with certain clinical characteristics in patients with NSCLC (eg,~     female, minimal and remote smoking history, and adenocarcinoma histology).~   "
243675|NCT00364767|"~     Moderate alcohol consumption is associated with a decreased risk of diabetes type 2. This~     association could be mediated by an improvement of insulin sensitivity with moderate alcohol~     consumption. Patients with diabetes type 2 or impaired glucose tolerance often may have~     decreased fat oxidative capacity or oxidative phosphorylation in tissue such as muscle. This~     could lead to accumulation triglyceride storage in muscle, which could interfere with insulin~     signaling. Whether such mechanism can also play a role with moderate alcohol consumption is~     unknown and will be investigated in this study.~      In addition, moderate alcohol consumption with a meal can lead to delayed hypoglycemia in~     type 1 diabetes patients. How moderate alcohol consumption affects postprandial glycemic~     response in healthy subjects is unknown. This is a secondary objective of this trial.~   "
243676|NCT00364754|"~     This is a Phase I, multi-centre, open-label, cross-over pharmacokinetic study designed to~     investigate whether the co-administration of a fixed dose of tesmilifene alters the plasma~     pharmacokinetics of a standard regimen of epirubicin and/or its principle metabolite,~     epirubicinol and cyclophosphamide.~   "
243677|NCT00364741|"~     Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as~     opposed to normally 30%) on surgical wound infection and pulmonary complications after~     abdominal surgery.~      Background: Surgical wound infection is a common and serious complication. Tissue oxygen~     tension is often low after surgery and the resistance against infection depends on this~     factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and~     it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound~     infection is reduced. Previous studies to test this hypothesis have shown entirely different~     results. Hence, the clinical decision between high and normal oxygen concentration is still~     controversial.~      Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound~     infection after abdominal surgery.~      Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications~     (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length~     of postoperative hospitalization and admission to intensive care unit after abdominal~     surgery.~   "
243678|NCT00364728|"~     Over the past few years, growing evidences revealed that clearance of apoptotic cells by~     phagocytosis can result in powerful anti-inflammatory and immunosuppressive effects. In vivo,~     apoptotic cells are cleared rapidly by neighboring cells, macrophages and related scavengers.~     Defective clearance of apoptotic cells has been linked closely to autoimmunity and persistent~     inflammatory disease. Several phagocytic receptors, bridging molecules produced by phagocytes~     and 'eat-me' signals on apoptotic cells are coordinately involved in mediating clearance of~     apoptotic cells. Complement receptors (CR3, CR4), collection, CD14, CD36 (Class B scavenger~     receptor), class A scavenger receptor, asialoprotein receptor, Mer receptor kinase were~     reported to recognize apoptotic cells. The best characterized system for clearance of~     apoptotic cells is the recognition of phosphatidylserine (PS) on apoptotic cells by~     phosphatidylserine receptor (PSR). Milk fat globule- epidermal growth factor 8 (MFG-E8) is an~     opsonin that bridges phagocytes (by interacting with α vβ3, αvβ5 integrins via RGD motif) and~     apoptotic cells (by binding PS through Factor V/VIII-C domain). Activated macrophages produce~     and secret MFG-E8. MFG-E8 is a critical component in PSR-mediated phagocytosis of apoptotic~     cells. The dominant negative mutant MFG-E8, D89E, that carried a mutated RGD motif inhibited~     phagocytosis of apoptotic cells in vitro. Injection of D89E into wild type mice induced~     autoantibodies and IgG deposition on glomeruli. Macrophages from MFG-E8 deficiency~     (MFG-E8-/-) mice were impaired in engulfment of apoptotic cells, which can be restored by~     adding recombinant MFG-E8. The female MFG-E8-/- mice spontaneously produced high titer of~     autoantibodies and developed lupus-like glomerulonephritis at the age of week 40. Defective~     clearance of apoptotic cells is closely related to development of autoimmunity. In the past 4~     years, a growing number of molecules were recognized as receptors for the PS exposed on the~     apoptotic cells. These molecules were capable of mediating phagocytic clearance, rendering~     anti-inflammatory cytokines in the phagocytes, and modulating T cell responses.~      The specific aim of this proposal is to study genetic polymorphism in MFG-E8, PSR and other~     factors implicated in phagocytic clearance of apoptotic cells among Taiwanese. By comparing~     the polymorphism between patients with autoimmune disease (SLE or RA) and healthy control~     subjects, we will investigate if genetic variations among individuals of genes encoding~     proteins involved in clearance of apoptotic cells contribute to the pathogenesis of systemic~     autoimmune diseases SLE and RA.~   "
243679|NCT00364715|"~     Recent studies have shown that dysregulation of ANXA1 expression are associated with~     tumorigenesis. Overexpression of ANXA1 protein is found in a wide variety of human tumors,~     such as breast 10, liver 11, pancreatic cancer14 and glial tumors15. In contrast, reduced~     levels of ANXA1 protein expression have been reported in ESCC4, 5, gastric6, breast7, head~     and neck SCC8 and prostate cancer9. No previous study on ANXA1 protein expression has been~     reported in the cancer of oral cavity. Furthermore, although alterations in annexin~     expression in different types of tumors have been described, no correlation has been~     established between ANXA1 and overall patient survival yet.~      ANXA1 is a major cellular substrate of the oncogenic tyrosine kinases such as EGF receptor~     and hepatocyte growth factor (HGF) receptor, c-met. Previously, we have shown that expression~     of HGF and c-met is significantly associated with the progression of OSCC in Taiwan.~     Kermorgant et al. recently showed that PKC controls HGF-dependent c-met traffic, signaling~     and cell migration. Prior study indicate that the mitogen phorbol-12-myristate 13-acetate~     (PMA) induced ANXA1 nuclear translocation in a PKCdelta-dependent manner and ANXA1 nuclear~     translocation may participate in the regulation of cellular proliferation and the~     differentiation. However, it is not known whether HGF can induce ANXA1 nuclear translocation~     or not and how this relates to the pathogenesis of oral SCC.~      In this study we aimed to investigate whether HGF induced the translocation of ANXA1 protein~     to the nucleus in OSCC cells and the role(s) of ANXA1 nuclear localization in the~     carcinogenesis of OSCC using an immunohistochemical technique. The data suggest a novel~     mechanism for HGF-induced ANXA1 protein nuclear translocation that may play an important role~     in the pathogenesis and prognosis in oral SCCs.~   "
243680|NCT00364702|"~     Using a virtual reality program in screening and treatment of ADHD.~   "
243714|NCT00364260|"~     The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the~     normal range, will prevent or delay the progression of left ventricular mass growth.~   "
243891|NCT00361894|"~     The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is~     safe and prevents blood clot which may form after a knee replacement operation.~   "
243681|NCT00364689|"~     The purpose of this study is to compare the effectiveness of three different treatments for~     hepatic encephalopathy. These treatments are:~        -  Group 1 - lactulose given with a rifaximin placebo (sugar pill)~        -  Group 2 - lactulose given with rifaximin~        -  Group 3 - rifaximin given alone~      The goals of this study are to determine which treatment is most effective at (1) reducing~     admissions to hospital for hepatic encephalopathy and (2) improving mental function, during~     the study period.~   "
243682|NCT00364676|"~     This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of~     vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's~     lymphoma, or Hodgkin's disease.~   "
243683|NCT00364663|"~     We plan to conduct a prospective study:~        1. to evaluate the accuracy of PET in staging patients with potentially operable non-small~          cell lung cancer;~        2. to evaluate the percentage of futile thoracotomy after PET is introduced in the routine~          staging modalities for NSCLC patient;~        3. to establish a decision tree model based on choices between conventional imaging only~          and additional PET imaging to analyze their cost-effectiveness.~   "
243684|NCT00364650|"~     We hypothesize that the administration of a combination of high numbers of probiotic bacteria~     will maintain normal bowel function and significantly moderate or obviate Immunosuppression~     Associated Diarrhea following kidney transplantation.~   "
243685|NCT00364637|"~     Patients undergoing stenting procedures, or cardiac or non-cardiac surgery could develop~     myocardial damage as testified by cardiac troponin release.~      Sevoflurane (volatile anesthetic), routinely used in cardiac and non-cardiac anesthesia, has~     cardioprotective properties that could be useful to reduce cardiac damage, as indicated by~     cardiac troponin release in different contexts:~        -  stenting procedures (periprocedural administration)~        -  non-cardiac surgery (during the whole procedure)~        -  cardiac surgery (during the whole procedure)~   "
243686|NCT00364624|"~     Patients with newly diagnosed lung cancer may have hypofunction of the adrenal cortex either~     from tumour metastasis or other mechanisms. Since lung cancer patient may have to undergo~     stressful investigation and treatments, undetected hypofunction of the adrenal cortex may be~     hazardous. Knowledge of the size of the problem may help determine whether routine check is~     warranted.~   "
243687|NCT00364611|"~     Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study~     designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab~     for the first-line treatment of participants with metastatic breast cancer. Participants were~     stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of~     enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab~     (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and~     trastuzumab (DBT).~      All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis~     and safety analysis was performed using the cut-off date of June 2011. One participant~     continued treatment till 11 March 2012. For this participant, adverse events were collected~     upto 19 April 2012 and included in the safety analysis.~   "
243688|NCT00364598|"~     The purpose of this study is to obtain human heart tissue after treatment with Anginera to~     determine its effect on a variety of things that might indicate improvement in heart~     function. Patients who will have a left ventricular assist device (LVAD) implanted while they~     wait for a donated heart will be treated with Anginera. At the time of heart transplant,~     their diseased heart which is removed will be analyzed by microscopic examination to see what~     effect Anginera had.~   "
243689|NCT00364585|"~     The purpose of this study is to evaluate the performance of the GreenLight™ model 120~     delivering higher average power to allow for more flexibility in the working distance of the~     delivery device with the same power density to tissue as that of the current GreenLight~     model. In addition this study will examine the Laserscope GDD (guided delivery device) that~     has been designed exclusively for use with the GreenLight™ model 120.~   "
243690|NCT00364572|"~     Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor~     for the development of radiculopathy. In animal studies, the application of TNF-alpha to~     nerve roots results in pain behavior indicative of radiculopathy. The use of TNF-alpha~     inhibitors (etanercept and infliximab) have been shown to prevent this pain behavior.~     Open-label studies in humans have shown both etanercept and infliximab provide excellent,~     long-term relief in patients with acute radiculopathy from herniated disc. However, a recent~     placebo-controlled study failed to demonstrate any significant difference from placebo. The~     investigators have already established the safety of neuraxial etanercept in a trial that has~     just been completed (not yet published). The objective of this study is to determine whether~     small doses of epidural etanercept, an anti-TNF-a medication, is an effective treatment for~     LBP caused by nerve root irritation (i.e., radiculopathy).~   "
243691|NCT00364559|"~     The purpose of this study is to determine whether rosuvastatin is effective in the management~     of acute phase of intracerebral hemorrhage and if it impact outcome by NIHSS.~   "
243692|NCT00364546|"~     The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50~     mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in~     patients who have chronic pain.~   "
243693|NCT00364533|"~     The purpose of this study is to test in patients who have had hip replacement surgery the~     effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503~     compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to~     assess the safety of the drug for 9 days after patients completed the double blind period.~   "
243694|NCT00364520|"~     The purpose of this study is to investigate the health effects of benzene exposure in workers~     in Shanghai, China.~   "
243695|NCT00364507|"~     this study will try to determine whether serum levels of insulin like growth factor are~     higher in fertile women than infertile women.~   "
243696|NCT00364494|"~     An hematocrit of 21-25% is supposed to perform the best organ protection during~     cardiopulmonary bypass for cardiac surgery.~      The investigators want to establish the best timing for a transfusion (in patients with a~     predicted low hematocrit during cardiopulmonary bypass) and the efficacy of preprocedural~     hemodilution (in patients with a predicted high hematocrit during cardiopulmonary bypass) in~     patients undergoing cardiac surgery.~   "
243697|NCT00364481|"~     Tongue exercises are described to improved snoring and acid reflux symptoms. Acid reflux~     treatment has been found to improve obstructive sleep apnea to a limited degree. Upper airway~     resistance syndrome is caused by resistance to breathing, leading to multiple respiratory~     event related arousals, leading to daytime fatigue and other various physical ailments.~     Tongue base or retrolingual collapse is implicated in upper airway resistance syndrome. We~     will measure sleep quality and quality of life indices before and after treatment for~     subjects that undergo tongue exercises only, acid reflux treatment only, and those that~     undergo both treatments.~   "
243698|NCT00364468|"~     To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with~     a single injection of KRN125 or multiple daily injections of filgrastim.~   "
243699|NCT00364455|"~     The purpose of this study was to evaluate the effect of treatment with epoetin alfa~     (recombinant human erythropoietin) or placebo on anemia related quality-of-life and anemia in~     hormone-refractory (not responding to hormone therapy) prostate cancer patients.~   "
243700|NCT00364442|"~     A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone~     propionate and salmeterol was compared with concurrent administration of fluticasone~     propionate and salmeterol. Administration occurred over 14 days and tolerability, PK~     (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.~   "
243701|NCT00364429|"~     This study was designed to compare the [123]I-CNS 1261 binding to NMDA receptor between~     healthy volunteers and different subgroups of schizophrenic patients. Investigation of the~     potential influence of antipsychotic and concomitant medication on [123I] CNS 1261 binding is~     also relevant.Fifteen healthy subjects (male and female of non-child bearing potential) will~     be recruited and 40 schizophrenic patients divided in 3 subgroups as indicated before:~     Subgroup a) treatment-naive, (n=10); Subgroup b) on stable treatment with risperidone~     (without criteria of deficit syndrome on the SDS scale, (n=15);Subgroup c) on stable~     treatment with risperidone fitting criteria of deficit syndrome on the SDS scale, (n=15).~   "
243702|NCT00364416|"~     The purpose of this study is to gather information to better understand the characteristics,~     medical management techniques and outcomes of patients with chronic severe Heart Failure~     (HF).~   "
243703|NCT00364403|"~     This study will compare the effects of a low glycemic load versus standard diet for pregnancy~     on outcomes related to risk for obesity, diabetes, and heart disease in both mother and~     infant.~   "
243704|NCT00364390|"~     This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular~     Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.~   "
243705|NCT00364377|"~     People with high fasting glucose can develop type 2 diabetes with the passage of time. This~     study is being done to determine the effect of a novel medication in people with this~     elevated fasting glucose. Sitagliptin is a substance that raises levels of a hormone normally~     found in the blood. This hormone, called glucagon-like peptide-1 (GLP-1), is normally~     released by the intestine in response to the presence of food. This hormone acts like a~     messenger between the intestine and the pancreas to raise insulin levels, and therefore,~     lower blood sugars. Sitagliptin is effective in people with diabetes, however, this study is~     being done to determine if Sitagliptin is effective in people with high fasting glucose who~     do not yet have diabetes.~   "
243706|NCT00364364|"~     This no treatment research study is being done to find a safe and an appropriate dose of~     antibody (protein) against tumor cells to best target the cancer in people with pancreatic~     cancer. To do this, this no-treatment research study will compare two doses of an antibody~     called hPAM4 IgG when combined with a radioactive element, Indium-111.~   "
243707|NCT00364351|"~     To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung~     Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy,~     Erlotinib~   "
243708|NCT00364338|"~     Subjects that participate in the practical workshop will improve their metabolic indexes,~     decrease their weight and improve their quality of life, in contrast to the participants that~     will take part in the nutritional consulting sessions~   "
243709|NCT00364325|"~     The purpose of this study is to collect data on the medical management of patients presenting~     to the Emergency Department who are treated for Acute Decompensated Heart Failure (ADHF) in a~     hospital setting that has incorporated a disease management program for heart failure.~   "
243710|NCT00364312|"~     Lifestyle interventions have been shown to reduce heart disease risk and improve blood sugar~     control in clinical trials. This project will investigate whether those lifestyle~     interventions can be implemented long-term, in usual practice settings, by using dietitian~     case managers to coordinate lifestyle change in cooperation with fitness instructors and~     primary care clinicians.~   "
243711|NCT00364299|"~     Background: The aspiration of contaminated secretions pooled above the endotracheal tube cuff~     secondary to inadvertent falls of cuff pressure is the main pathogenic mechanism of~     ventilator-associated pneumonia (VAP). Aim of the study: To assess the efficacy of an~     automatic device for the continuous regulation of tracheal tube cuff pressure in decreasing~     the incidence of VAP.~   "
243712|NCT00364286|"~     The goal of this clinical research study is to learn if dasatinib can help to control Chronic~     Lymphocytic Leukemia (CLL). The safety of the drug will also be studied.~      Optional Procedures: You will be asked to have additional blood samples drawn. These samples~     will be used to see how the disease is responding to the drug.~   "
243713|NCT00364273|"~     GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which~     is being developed for once daily treatment of asthma and COPD as part of a combination~     product with a once daily inhaled corticosteroid and also as a standalone product for the~     treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial~     smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related~     with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are~     limited by local administration and also tend to show tachyphylaxis.~      The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily~     administration, given their duration of action. Therefore, there is significant opportunity~     for a once-daily inhaled medication to improve patient compliance and overall disease~     management by providing sustained, 24-hour bronchodilation.~   "
243730|NCT00364039|"~     The purpose of this study is to determine the safety and tolerability of AV650 in healthy~     subjects given single and multi-doses under fasted and fed conditions.~   "
243715|NCT00364247|"~     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety~     of the administration of 3 different dose levels of CG5503 compared with oxycodone and with~     placebo in patients who have had a bunionectomy, and to assess the safety of the drug for 9~     days after patients are discharged from the hospital.~   "
243716|NCT00364234|"~     The proposed 6 month pilot and feasibility randomized trial will evaluate LMMS as an anabolic~     stimulus to bone in 30 adults on maintenance hemodialysis. The intervention will consist of~     20 minute daily sessions in the home standing on an active LMMS platform or a placebo device~     that emits an audible hum suggestive of an active device. Each device contains an electronic~     monitor that documents adherence. The study will examine trabecular bone volume fraction~     (bone volume/total volume, BV/TV %) and architecture using microMRI, and cortical volumetric~     BMD and dimensions using QCT at baseline and 6 months. The hypothesis is that active LMMS~     will results in greater mean changes in trabecular and cortical parameters in hemodialysis~     patients. The proposed study will test the feasibility of conducting the intervention in~     dialysis patients and will generate preliminary data on rates of change in trabecular and~     cortical parameters in the active and placebo groups.~   "
243717|NCT00364221|"~     The metabolic syndrome is a collection of health risks that includes obesity, high blood~     pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to~     insulin. The purpose of this study is to find out if the medication, rosiglitazone,~     influences levels of fat cell proteins and alters insulin resistance in nondiabetic persons~     with the metabolic syndrome. This is an early step to see if a medication, such as~     rosiglitazone, will be beneficial in people who have the metabolic syndrome.~   "
243718|NCT00364195|"~     This is a Phase II study designed to evaluate whether the co-administration of a fixed dose~     of tesmilifene and a standard regimen of docetaxel alters the plasma pharmacokinetics of~     docetaxel. This study will also assess the safety and efficacy of the tesmilifene/docetaxel~     combination in metastatic breast cancer patients.~   "
243719|NCT00364182|"~     This study is designed to evaluate BeneFIX infused as prophylaxis regimens, compared with~     BeneFIX administered as an on-demand regimen only. In the trial, subjects will participate in~     4 study periods. The first period is a 16-week on-demand treatment, during which subjects~     will utilize BeneFIX to treat bleeding events episodically only as they occur (i.e.,~     on-demand treatment). At the end of this period, subjects will be randomly assigned to 1 of 2~     BeneFIX prophylaxis regimens: either 100 IU/kg once weekly or 50 IU/kg twice weekly, and~     followed for 16 weeks. At the end of this period, subjects will use on-demand treatment for 8~     weeks. The purpose of this 8-week period is to mitigate the potential carry-over effect of~     the prior prophylaxis regimen on bleeding frequency. Following this 8-week on-demand~     treatment, subjects will cross-over and receive the alternate study prophylactic regimen for~     16 weeks.~      The primary endpoint is annualized number of bleeding episodes, compared between the first~     on-demand period and each of the prophylaxis regimens. A comparison of annualized bleeding~     episodes between the two prophylaxis regimens will also be performed. Subject-reported~     outcomes will also be collected using a patient diary. At 24 and 48 hours following the onset~     of each joint bleeding episode, information on pain, sleep, and work will be collected.~     Additional data on physical functioning will be recorded on the diary at the end of the~     16-week on-demand period, and at the end of each prophylaxis period. Information on safety~     will also be collected.~      Each subject will participate in this study for approximately 59 weeks (15 months), including~     a screening period of up to 3 weeks, an initial 16-week on-demand period, two prophylaxis~     treatment periods of 16 weeks each, separated by an 8-week on-demand treatment period.~      A modified FIX recovery study will be performed once during each prophylaxis period.~      The study diary will also be used by subjects to collect secondary endpoints. These~     endpoints, which are subject-reported outcomes, will be recorded in the diary at 24 and 48~     hours following the onset of each joint bleeding episode. Additional data on physical~     functioning will be recorded on the diary at the end of the 16-week on-demand period, and at~     the end of each prophylaxis period.~      Patients will be recruited in the United States, Canada, Europe and Russia.~   "
243720|NCT00364169|"~     The purpose of the study is to reduce the incidence of postoperative constipation by~     systematic nurse assessment, interventions and evaluation, in the first month after thoracic~     surgery.~   "
243721|NCT00364156|"~     This randomized double-blind, placebo-controlled will determine the relative efficacy of~     standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After~     completing the eligibility screening, 600 treatment-seeking smokers will be randomized to~     receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or~     extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral~     counseling. The primary outcome will be biochemically verified abstinence from smoking at the~     end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after~     treatment is discontinued), and time to failure. We hypothesize that ET will produce~     significantly higher quit rates than ST; however, the benefit of ET will last only so long as~     treatment is continued. Support for this hypothesis would indicate that maintenance therapy~     with TN should be considered.~   "
243722|NCT00364143|"~     The purpose of this study is to determine whether IHL-305 (irinotecan liposome injection) is~     safe and effective in the treatment of advanced solid tumors.~   "
243723|NCT00364130|"~     The purpose of this 12-month double blind, placebo controlled randomized trial is to evaluate~     the effects of daily treatments with low magnitude mechanical stimuli on bone in 160 children~     with Crohn disease.~   "
243724|NCT00364117|"~     The purpose of this study is to integrate Remote Presence technology in order to increase the~     number of timely patient discharges before 11 am from the medical center.~   "
243725|NCT00364104|"~     The investigators hypothesize that the Helicobacter pylori bacterium decreases iron from the~     stomach and that this effect of the infection can be identified among persons with iron~     deficiency as well as among persons with normal iron stores. The aim of this study is to~     determine whether Helicobacter pylori eradication in children is followed by an increase in~     markers of iron stores after six to twelve months of treatment.~   "
243726|NCT00364091|"~     The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025%~     ophthalmic solution compared with placebo or an active control in subjects with seasonal~     allergic conjunctivitis~   "
243727|NCT00364078|"~     Transitoriness can be defined as confrontation with life's finitude. Cancer patients are~     perceived to experience this confrontation due to their diagnosis. It is perceived to impact~     cancer patients' ways of coping with the disease situation. In this study, cancer patients'~     levels of uncertainty, transitoriness and their perceived locus of control are assessed. It~     is aimed at exploring the association of uncertainty, locus of control, transitoriness and~     quality of life. If a stronger correlation of one or the other issue with quality of life can~     be discovered, it will inform the development of an adequate evidence-based nursing~     intervention to better support patients' coping with the disease.~   "
243728|NCT00364065|"~     The purpose of this study is to see if the Ferris PainWrap is effective in the treatment of~     chronic low back pain.~   "
243729|NCT00364052|"~     Null Hypothesis:~      There is no significant difference in the incidence of CMV infection when using oral~     valganciclovir or ganciclovir as prophylactic anti-viral therapy.~      Alternate Hypothesis:~      There exists a significant difference in the incidence of CMV infection when oral~     valganciclovir is used for CMV prophylaxis rather than oral ganciclovir. A formal hypothesis~     to be tested should be defined.~   "
243731|NCT00364026|"~     This is a research study of a new experimental drug called darusentan. Darusentan is not~     currently approved by the U.S. Food and Drug Administration (FDA) for use in the United~     States, which means that a doctor cannot prescribe this drug. The purpose of this study is to~     determine if darusentan is effective in reducing systolic blood pressure in subjects with~     resistant systolic hypertension, despite treatment with full doses of three or more blood~     pressure lowering drugs, including a diuretic.~   "
243732|NCT00364013|"~     The purpose of this study is to determine the treatment effect of panitumumab in combination~     with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer~   "
243733|NCT00364000|"~     End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel~     calcifications, compared with the non-renal population. Both arterial stiffness and arterial~     calcifications are potent predictors of all-cause and cardiovascular mortality in ESRD~     patients. Several studies have documented the direct relationship between the extent and~     severity of arterial/coronary calcifications and outcome in dialysis patients. The~     relationship is strong no matter if arterial calcifications were quantified by electron-beam~     computed tomography or a radiological calcification score. Calcifications are early and~     progressive events in these patients. PWV is strongly related to the degree of sonographic~     determined arterial calcifications and EBCT-derived coronary artery calcium score in chronic~     kidney disease patients.~      Calcium-based phosphate binders are associated with progressive coronary artery and aortic~     calcification, especially when mineral metabolism is not well controlled.~      According to recent studies, sevelamer hydrochloride is a potent non-calcium-containing~     phosphate binder, well tolerated in ESRD. Compared with calcium-based phosphate binders,~     sevelamer is less likely to cause hypercalcemia, low levels of PTH, and progressive coronary~     and aortic calcification in hemodialysis patients. Moreover, sevelamer has a favorable effect~     on the lipid profile.~      Less is known about the relationship between sevelamer treatment and progression of arterial~     stiffness. To date, there is one single study examining the influence of sevelamer (versus~     calcium carbonate) on the evolution of arterial stiffness in a very small number (N=15) of~     haemodialysis patients. These study used the same patients as historical controls, thus being~     methodologically rather weak. Moreover, the follow-up was quite short - 6 month.~      The aim of the trial is to to quantify, in a randomized opened-labeled controlled trial the~     effect of sevelamer hydrochloride on the evolution of arterial stiffness parameters (pulse~     wave velocity and the augmentation index) in chronic haemodialysis patients and to correlate~     these parameters with arterial calcification assessed by a previous described radiological~     score of arterial calcification and echocardiographic parameters (left ventricular~     hypertrophy, LV dilatation, systolic and diastolic dysfunction).~   "
243734|NCT00363987|"~     Current expert opinion based consensus guidelines recommend usage of α-Keto analogues of~     essential amino acids in the diet of diabetic nephropathy patients, along with restricted~     protein diets. This study is designed to explore whether alpha-Keto Acid supplementation with~     low protein diet will retard progression of type 2 diabetic nephropathy and also to assess~     effects of such supplemented diets on nutritional and other parameters in this patient group.~   "
243735|NCT00363974|"~     The purpose of this study is to determine if the drug, called AEG35156, can be safely given~     to AML patients and whether it effectively reduces levels of a protein (XIAP) to increase the~     sensitivity of cancer cells to chemotherapy (ara-C and idarubicin) in patients with~     refractory or relapsed AML.~   "
243736|NCT00363961|"~     There is a rising incidence of kidney failure in the US, with poor outcomes and high cost.~     End-stage renal disease (ESRD) affects almost 375,000 individuals in the US at a cost of more~     than $14 billion per year. Despite advances in dialysis and transplantation therapies, kidney~     failure leads to poor outcomes, poor prognosis and high health care costs. Malnutrition and~     the underlying systemic inflammatory response developed during the course of chronic kidney~     disease, worsen during ESRD, and lead to adverse outcomes, increased morbidity and mortality.~     Muscle wasting, impaired functional capacity and poor quality of life are the most important~     factors associated with malnutrition and inflammation in renal failure. We have shown in pre~     dialysis patients with moderate chronic renal insufficiency that the anabolic effects of~     resistance exercise training result in significant improvements in protein utilization,~     nutritional status and functional capacity even in the context of anorexia and prescribed low~     protein diets. Therefore, we propose to develop, test and implement a progressive resistance~     exercise routine for ESRD patients during the hemodialysis session. By implementing such~     intervention, we hope to offer a therapeutic strategy that can be incorporated to the~     standard of care of ESRD patients by working in conjunction with the dialysis unit staff.~   "
243737|NCT00363948|"~     The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in~     patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise~     therapy and metformin as monotherapy~   "
243738|NCT00363935|"~     After obtaining informed consent,80 morbidly obese ASA II-III patients undergoing~     laparoscopic bariatric surgery procedures would be randomly assigned to one of four study~     groups at UTSWMC at Dallas.Hemodynamic paarameters, recovery times, postoperative pain~     scores, the need for rescue analgesics and side effects will be recorded.The purpose of this~     study is to determine the optimal linfusion rate of dexmedetomidine for maintaining~     cardiovscular stability during general anesthesia.~   "
243739|NCT00363922|"~     The purpose of this study is to compare different types of rehabilitation after coronary~     bypass surgery. The investigators wish to compare rehabilitation in an institution for four~     weeks with a home based rehabilitation. They also wish to compare rehabilitation in an~     institution for four weeks with a rehabilitation program were the patients live at home but~     visit the hospital twice a week for twelve week. The investigators will measure the patients'~     physical capacity by measuring their maximal oxygen consumption. The investigators will also~     analyze their blood and their endothelian function (how well their arteries dilate).~   "
243740|NCT00363909|"~     RATIONALE: Citalopram may help relieve hot flashes in women who had or have not had breast~     cancer. It is not yet known which dose of citalopram is more effective in treating hot~     flashes in postmenopausal women.~      PURPOSE: This randomized phase III trial is studying three different doses of citalopram to~     compare how well they work in treating postmenopausal women with hot flashes.~   "
243741|NCT00363896|"~     To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with~     moderate to severe COPD during one year of treatment.~   "
243742|NCT00363883|"~     Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. This phase II trial is studying how well vorinostat works in treating patients with~     locally recurrent or metastatic cancer of the urothelium.~   "
243743|NCT00363870|"~     The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza~     vaccine (Fluarix™) administered intramuscularly in adults.~   "
243744|NCT00363857|"~     A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and~     placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome~     (RLS) in the United States.~   "
243746|NCT00363831|"~     Primary:~        -  To evaluate the efficacy of capecitabine in combination with oxaliplatin (XELOX) in~          terms of overall response rate (based on RECIST criteria) in patients with metastatic~          NPC without prior chemotherapy for relapse.~      Secondary:~        -  To evaluate the efficacy profile of oxaliplatin (XELOX) in patients with metastatic NPC~          in terms of time to progression of disease, survival time, duration of response and~          complete response rate.~        -  To study the safety and tolerability of the regimen in patients with metastatic NPC.~   "
243747|NCT00363818|"~     The proposed study is a prospective one, and will be held on consecutive individuals~     undergoing the non-invasive brachial artery flow-mediated dilation (FMD) ultrasound for~     endothelial function at the endothelial function laboratory of the Sheba Medical Center. The~     study group will be divided into healthy subjects group and coronary artery disease (CAD)~     patients group, both of which will be analyzed in respect to age, cardiovascular risk factors~     and the results of the platelet and endothelial functions tests. The association between~     platelet and endothelial functions will be then assessed in the healthy subjects group and in~     the CAD patients group.~   "
243748|NCT00363805|"~     RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming,~     growing, or coming back. The use of green tea or polyphenon E may prevent cancer from forming~     in former smokers with chronic obstructive pulmonary disease.~      PURPOSE: This randomized phase II trial is studying how well green tea or polyphenon E work~     in preventing lung cancer in former smokers with chronic obstructive pulmonary disease.~   "
243749|NCT00363792|"~     In healthy subjects different cerebral haemodynamic values wished to be determined after~     infusion of the NO donor Glyceryl trinitrate (GTN) and Diamox. The different values we wish~     to determine are:~        -  Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.~        -  Changes in the diameter of a. cerebri media.~        -  Changes in the regional and global cerebral blodd flow (CBF) with the help of the~          arterial Spin labeling (ASL) method.~   "
243750|NCT00363779|"~     Background:~        -  Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma.~        -  LGL is associated with low numbers of white blood cells (leading to recurring~          infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding).~        -  Cyclosporine (CSA) is an immunosuppressive drug that improves low blood cell counts in~          about 50 percent of patients with LGL leukemia.~      Objectives:~        -  To identify what factors determine why cyclosporine works in some patients and not in~          others.~        -  To identify what causes low blood counts in LGL leukemia.~      Eligibility: Patients 18 years of age and older with LGL leukemia.~      Design:~        -  Patients have a medical history, physical examination blood tests, bone marrow biopsy~          and x-ray studies, including chest x-rays and computed tomography (CT) scans of the~          chest, abdomen and pelvis. Patients with an easily accessible enlarged lymph node have a~          node biopsy (removal of a small piece of tissue for microscopic examination).~        -  Patients take cyclosporine twice a day by mouth. Blood samples are taken at least weekly~          to adjust the cyclosporine dosing to maintain therapeutic serum levels.~        -  Patients undergo apheresis (collection of white blood cells) at a number of different~          time points in the study (maximum 6 times) to look at the differences in the leukemia~          cells before and during treatment with cyclosporine. For apheresis, blood is withdrawn~          through a needle in an arm vein and directed through a catheter (plastic tube) into a~          machine that separates it into its components. The white cells are extracted and the~          rest of the blood is returned through the same needle or through a second needle in the~          other arm.~   "
243751|NCT00363766|"~     The primary objective is to estimate the time to progressive disease for patients who receive~     LY573636 after two previous treatments for metastatic non-small cell lung cancer. Patients~     will receive an intravenous infusion of study drug once every 21 days. CT-scans will be done~     before the first dose and then after every other treatment.~   "
243752|NCT00363753|"~     Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient~     ischemic attack.~   "
243753|NCT00363740|"~     This study was designed to compare the efficacy and safety of an investigational nasal spray~     compared with placebo nasal spray and commonly used drug in the treatment of seasonal~     allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that~     occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis~     (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses,~     and weeds. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and~     pruritic, watery, red eyes.~   "
243754|NCT00363727|"~     This study evaluates how effective a new formulation of a marketed drug is in increasing the~     time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with~     Parkinson's Disease who have been taking levodopa for less than 2 years.~   "
243755|NCT00363714|"~     The purpose of this study will be to assess the safety and tolerability and dose-limiting~     toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the~     anatomical changes in the retina, changes in CNV, and changes in visual acuity. Escalation to~     the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will~     be monitored intensively for three months, and then followed-up for safety up to 24 months~     post-injection.~   "
243756|NCT00363701|"~     The primary purpose of the study is to determine the effect of esomeprazole compared to~     placebo in patients from general practice who have previously been treated with~     proton-pump-inhibitors (PPI) and who have no upper endoscopic findings.~   "
243757|NCT00363688|"~     The purpose of this study is to examine whether oral challenge with penicillin for patients~     with a known history of non-life threatening allergic reaction to penicillin is~     well-tolerated irrespective of skin-testing results~   "
243758|NCT00363675|"~     This study is designed to see if some tests of hand movement, strength, and function are~     valid for children with burns.~   "
243788|NCT00363272|"~     This phase I trial is studying the side effects and best dose of ispinesib in treating young~     patients with relapsed or refractory solid tumors or lymphoma. Drugs used in chemotherapy,~     such as ispinesib, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing~   "
243892|NCT00361881|"~     The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and~     placebo for the treatment of recurrent herpes labialis.~   "
243759|NCT00363662|"~     The overall aim of this project is to prospectively determine whether MRI can improve the~     conventional neuroradiological evaluation (CT with or without cerebral angiography) of~     patients with a spontaneous ICH or IVH. The study design will also allow us to identify the~     added benefit of specific MR sequences and repeat MRI in the chronic stage, thereby allowing~     us to prospectively determine their value in a consecutive series of patients. This~     information should have a major impact on the management of these patients by providing data~     on the diagnostic yield of routine MRI in patients presenting with a wide variety of causes~     for ICH or IVH. These data will help guide the diagnostic evaluation and the management of~     brain hemorrhage patients in the future.~   "
243760|NCT00363649|"~     RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer~     cells. GM-CSF may help cells that are involved in the body's immune response work better.~     Vaccines made from a person's cancer cells may help the body build an effective immune~     response to kill cancer cells.~      PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon~     alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine~     therapy in treating patients with chronic phase chronic myelogenous leukemia.~   "
243761|NCT00363636|"~     This is a Phase III, multicenter, global, clinical study of an investigational drug called~     galiximab in combination with an approved drug called rituximab in subjects with follicular~     NHL.~      The purpose of the study is to compare the clinical benefit of galiximab when given in~     combination with rituximab as compared with rituximab alone (given with placebo) in subjects~     with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be~     evaluated.~   "
243762|NCT00363623|"~     The primary purpose of this study is to investigate the performance of contact lens~     maintenance systems when used with silicone hydrogel contact lenses during daily wear over a~     period of 1 month.~   "
243763|NCT00363610|"~     This study will research the side effects of pegaspargase (pronounced peg-as-par-gase); its~     brand name is ONCASPAR® when it is used with another FDA-approved cancer treatment~     (chemotherapy) drug called gemcitabine HCl (pronounced gem-site-a-bean; its brand name is~     GEMZAR®.~   "
243764|NCT00363597|"~     The main purpose of this study is to evaluate whether intestinal permeability and/or serum~     zonulin concentration is increased in children/adolescents with functional dyspepsia (FD).~     The study will also explore the relationships between intestinal permeability, mucosal~     inflammation and anxiety in FD patients.~   "
243765|NCT00363584|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving capecitabine after surgery may kill any tumor cells that remain after surgery.~     Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this~     case, observation may be sufficient. It is not yet known whether capecitabine is more~     effective than observation in treating biliary tract cancer.~      PURPOSE: This randomized phase III trial is studying capecitabine to see how well it works~     compared with observation in treating patients with biliary tract cancer.~   "
243766|NCT00363571|"~     After infusion / injection of Glyceryl trinitrate and Diamox it is wished to study the effect~     of drugs on the cerebral haemodynamics such as Cerebral blod flow and cerebral blod volume.~   "
243767|NCT00363558|"~     Skin graft fixation is essential for the success of its survival. There are several common~     methods for skin graft fixation including sutures, skin staples and glue. The study objective~     is to compare between skin graft fixation with staples and glue in burn patients. The study~     is retrospective. It Includes 44 patients that were hospitalized in the burn unit, Rabin~     Medical Center, Israel with 2nd and 3rd degree burns, total body surface area 1-50% during~     1/2002-5/2003.All patients were operated for debridement and skin grafting. In 29 patients~     the skin graft was fixated with staples and in 15 with cyanoacrylate glue (histoacryl). The~     parameters that will be compared are skin graft take, hospitalization length and local~     infection.~   "
243768|NCT00363545|"~     This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the~     liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of~     GSK Biologicals' HRV vaccine~   "
243769|NCT00363532|"~     In patients known with migraine without aura a migraine headache or migraine like headache~     will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then~     be stimulated with noxious heat via a thermode placed at the forehead. At the same time the~     Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic~     resonance imaging (fMRI), to estimate the central-nervous pain response. The regions of~     interest (ROI) will be thalamic region and medulla oblongata.~      Then the patients will be given pain relif in form of injection of sumatriptan and the effect~     of this will also be registered via measuring the BOLD response at the RIO's previously~     defined. A 3-Tesla MRI scanner will be used in this trail.~      This study will give us key knowledge of the trigeminal pain pathway and the central~     processing i.e sensitization during a migraine attach.~   "
243770|NCT00363519|"~     The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in~     patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise~     therapy and glimepiride as monotherapy~   "
243771|NCT00363506|"~     The purpose of this study is to evaluate the use of nutritional supplementation and dietary~     management for the reduction in frequency, duration, and intensity of migraine headache pain.~   "
243772|NCT00363480|"~     The majority of asthma patients are not well controlled, despite the availability of asthma~     medication that could effectively treat the disease. In this study uncontrolled patients who~     are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide~     (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test~     (ACT) will be used to detect differences in the level of asthma control during treatment. The~     study aims to show a correlation between improvements of ACT und the level of asthma control~     which will be reached by the patients.~      The aim of the study is to show that most of symptomatic asthma patients can reach 'well~     controlled asthma' with SFC. We get information about ACT in daily practice and physicians~     are trained to use the asthma control test as a screening tool and for follow up of asthma~     management. Correlations are expected between the improvements in ACT, Quality of Life and~     asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.~   "
243773|NCT00363467|"~     During the pre-transplantation phase (following completion of consolidation chemotherapy),~     patients will begin to receive G-CSF at 10 mcg/kg twice daily; leukapheresis will also be~     given until a target goal for recipient body weight is obtained, or up to a maximum of 5~     days. Conditioning/Preparative therapy will follow PBSC collection for up to 30 days with~     Busulfan IV daily x 4 days; subsequent doses will be adjusted based on pharmacokinetic~     (plasma level)monitoring. Following 1 day of rest, stem cell reinfusion will begin with~     supportive care. During follow-up, patients will be monitored out to 730 days.~   "
243774|NCT00363454|"~     Phase I dose escalation study of Triciribine Phosphate Monohydrate (TCN-PM) in patients with~     metastatic cancer whose tumors must be shown to be p-Akt positive. Study patients will be~     recruited from a Moffitt Cancer Center companion study (MCC-14474) Immunohistochemical study~     of phosphorylated Akt in solid malignancies.~      Each treatment cycle will consist of four weeks with TCN-PM being administered weekly (days~     1, 8 and 15 every 28 days). Labs, vital signs (BP, HR, Resp Rate, Temp), and hematology and~     serum chemistry profile are to be performed weekly and/or prior to each treatment dose. Body~     Surface Area (BSA) should be calculated approximately every 8 weeks. Imaging studies (CT/MRI~     of chest, abdomen, and pelvis) and tumor response assessments will be performed every eight~     weeks or more frequently if indicated. Unless unacceptable toxicity occurs, the duration of~     treatment will be based on tumor reassessment.~   "
243775|NCT00363441|"~     This is a randomized study of conventional 3d radiation versus intensity-modulated radiation~     in squamous cell cancer of the head and neck.~   "
243776|NCT00363428|"~     RATIONALE: Exercise may help improve lung function and lessen complications of surgery in~     patients with chronic obstructive pulmonary disease who are undergoing surgery for lung~     cancer. It is not yet known whether lung rehabilitation is more effective than standard~     therapy in improving lung function in patients with chronic obstructive pulmonary disease who~     are undergoing surgery for lung cancer.~      PURPOSE: This randomized clinical trial is studying lung rehabilitation to see how well it~     works compared to standard therapy in treating patients with chronic obstructive pulmonary~     disease who are undergoing surgery for lung cancer.~   "
243777|NCT00363415|"~     This study is a Phase 3, global, multi-center, open-label study of patients with~     extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to~     receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated~     that pemetrexed plus carboplatin will offer similar survival benefits as compared to~     etoposide plus carboplatin.~   "
243778|NCT00363402|"~     Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the CF~     trans-membrane conductance regulator (CFTR) protein. CF is the most common inherited disease~     of Caucasians, with a carrier frequency of 1 in 25-30 individuals. Even with the impressive~     advances achieved in the understanding of the molecular basis and physiopathology of CF, it~     remains a life-threatening disorder that causes severe lung damage and nutritional~     deficiencies. It is generally accepted that early therapy could delay the progression of lung~     disease. A number of non-invasive methods are available to monitor disease activity in CF~     patients; however none of the currently used tools are able to monitor real-time events.~     Recently high resolution computed tomography (HRCT) has been used to monitor changes in lung~     structure. However, HRCT does not allow differentiating between acute and chronic lesions.~     Positron emission tomography (PET) with 18fluoro-deoxy-glucose (FDG) has already been used in~     a variety of settings to visualize inflammation or infection. FDG-PET imaging appears to be a~     promising new tool to quantify inflammation as it can detect clinically relevant changes even~     when no changes or minimal ones are detected by morphologic imaging. PET/CT may consequently~     be used to evaluate the severity of lung inflammation/infection in CF patients, and therefore~     the aim of this study is to evaluate the use of PET/CT for the assessment of the severity of~     lung inflammation/ infection in CF patients.~   "
243779|NCT00363389|"~     To investigate if self-inserted vaginal misoprostol prior to outpatient hysteroscopy will~     lead to satisfactory cervical ripening, compared to placebo.~   "
243780|NCT00363376|"~     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of~     zonisamide therapy in the prevention of weight gain associated with olanzapine treatment for~     psychotic or bipolar disorders.~   "
243781|NCT00363363|"~     The purpose of this study is to determine which is the most effective intervention for~     increasing lifestyle physical activity in Fontan patients: an education (stage of change)~     intervention or a physical activity (mastery experience) intervention.~   "
243782|NCT00363350|"~     This study is an evaluation of the effect of rituximab compared to placebo in combination~     with steroids on salivary flow and serological and clinical parameters in patients with~     primary SS.~   "
243783|NCT00363337|"~     The specific aim of this study is to obtain preliminary evidence of the acute effectiveness~     and tolerability of aripiprazole in the treatment of bipolar depression.~   "
243784|NCT00363324|"~     This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in~     patients with a acute myocardial infarction.~   "
243785|NCT00363311|"~     The purpose of this study is to examine the effect of dutasteride on the inhibition of~     low-risk, localized prostate cancer progression in men who would otherwise receive no active~     therapy (expectant management).~   "
243786|NCT00363298|"~     The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective~     when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and that tolerance~     (loss of therapeutic effect) to the medication will not develop over a period of several~     weeks.~   "
243787|NCT00363285|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as~     cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor~     may not need treatment until it progresses. In this case, observation may be sufficient. It~     is not yet known whether giving cyproterone acetate continuously is more effective than~     giving cyproterone acetate after tumor progression in treating prostate cancer.~      PURPOSE: This randomized phase III trial is studying cyproterone acetate to compare how well~     it works when given continuously or after tumor progression in treating patients with newly~     diagnosed stage III or stage IV prostate cancer.~   "
243820|NCT00362830|"~     The purpose of the study is to test how vinflunine interacts with ixabepilone in the human~     body.~   "
243789|NCT00363259|"~     The purpose of this study is to compare the sustained virological response rate at 24 weeks~     after the end of experimental treatment (induction and 72 weeks) to that of standard 48 weeks~     treatment with PEG-inteferon alfa-2b and ribavirin in patients with chronic hepatitis C~     previous unresponsive to interferon alfa monotherapy or interferon alfa/ribavirin combination~     therapy.~   "
243790|NCT00363246|"~     The purpose of this study is to find out about the risk factors for wheelchair-related falls~     among elderly veterans, and to find out about the costs and consequences of those falls.~   "
243791|NCT00363233|"~     The purpose of the study is to improving the lipid profile and glucose control in type 2~     diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans~     supplement will improve the cholesterol profile and glucose control in type 2 diabetic~     patients.~   "
243792|NCT00363220|"~     The purpose of this study is to review patients with E. coli infections at the University of~     Pittsburgh Medical Center (UPMC) from September 1, 2006 to August 31, 2007 to determine if~     these infections have arisen in the community rather than in hospitals or nursing homes. The~     occurrence of such resistant isolates could be devastating if they were associated with~     bloodstream infection, such as sometimes accompanies a urinary tract infection, since~     antibiotic resistant E. coli is not suspected in isolates coming from the community.~     Therefore, the aims of this study are to:~        1. Review whether extended-spectrum beta-lactamase (ESBL)-producing organisms (E. coli,~          Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated, or~          community-associated.~        2. Investigate the prevalence of ESBL-positive E. coli in foodstuffs (beef, poultry,~          turkey, and pork), as a potential source for ESBL producers in the community.~        3. Compare the clonal relationship of the genome and resistance plasmids carried by the~          ESBL-producing isolates (healthcare-associated, community-associated, and of animal~          origin) and study the associations of ESBL-mediated resistance with resistance to other~          classes of antimicrobials.~   "
243793|NCT00363207|"~     In children, behavior management is critical to the success of pediatric dental procedures.~     Most of the studies on local anesthesia performed in children deal with the question how to~     avoid or minimize pain during injection. Due to the sensation of numbness children scratch~     the soft tissues and bite lips and tongue. In many cases, this may be kept in children's~     memory as a painful experience and may affect their behavior in the following visit. The~     purpose of this study is to evaluate children's reactions to the administration of local~     anesthetic injection in the mandible (mandibular block) and in the maxilla (supraperiosteal~     infiltration), and to assess their behavior in the following visit related to each type of~     injection.~   "
243794|NCT00363194|"~     This is two-part study (Part I/Part II). Part I is designed to determine the effect of a low~     and high fat meal on the pharmacokinetics of single dose pazopanib (GW572016). Part II is~     designed to allow patients continued access to study drug in a multiple dosing regimen.~     Patients who are receiving clinical benefit on that regimen will go into the long term~     rollover study VEG105430 provided they are stable for 8 weeks.~   "
243795|NCT00363181|"~     Medications like olanzapine have been associated with the development of weight gain and~     diabetes in some patients. It is not known if the increased risk of developing diabetes is a~     direct effect on insulin or simply related to weight gain.~      We hope to learn in this study whether or not olanzapine directly slows down insulin~     secretion from the pancreas, thereby increasing the risk of developing diabetes.~   "
243796|NCT00363168|"~     This research is being done to look at the effects of an experimental drug, ranibizumab, on a~     condition called predominantly hemorrhagic subfoveal choroidal neovascularization (CNV) due~     to wet age-related macular degeneration.~      A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal~     neovascular lesion is occupied by blood under the retina. We want to find out if injections~     of ranibizumab into the eye will help patients with this condition.~   "
243797|NCT00363155|"~     The purpose of this trial is to determine the safety, tolerability and effectiveness of~     KRN7000 for chronic hepatitis B infection.~   "
243798|NCT00363142|"~     This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted~     fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen~     administered either twice-daily or once-daily.~   "
243799|NCT00363129|"~     RATIONALE: Vitamin E may prevent peripheral neuropathy caused by chemotherapy in patients~     with cancer. It is not yet known whether vitamin E is more effective than a placebo in~     preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy~     for cancer.~      PURPOSE: This randomized phase III trial is studying vitamin E to see how well it works~     compared with placebo in preventing peripheral neuropathy caused by chemotherapy in patients~     receiving chemotherapy for cancer.~   "
243800|NCT00363116|"~     The purpose of the study is to determine the safety and efficacy of two dosing regimens of~     daclizumab in simultaneous kidney/pancreas transplant recipients.~   "
243801|NCT00363090|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from growing.~     Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab when~     given together with combination chemotherapy and to see how well they work in treating~     patients with newly diagnosed aggressive stage II, stage III, or stage IV T-cell~     non-Hodgkin's lymphoma.~   "
243802|NCT00363077|"~     The purpose of this study is to evaluate the immunogenicity and the safety of the candidate~     vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above~   "
243803|NCT00363051|"~     The purpose of this study was to assess the efficacy and safety of everolimus in the~     treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic~     chemotherapy. All patients were treated with everolimus until either tumor progression was~     documented using a standard criteria that measures tumor size called Response Evaluation~     Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the~     patient or investigator requested discontinuation of treatment.~   "
243804|NCT00363038|"~     The objective of this study is to assess the comparative utility of topical formulations in~     hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm~     diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using~     a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K,~     1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per~     subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist~     rated bruises in standardized photographs immediately after bruise creation and at week 2.~   "
243805|NCT00363025|"~     In this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared~     idarubicin or daunorubicin throughout the study (first randomization) and two different~     post-remission strategies (second randomization): one single intensive consolidation course~     similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin~     (day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly~     basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence~     for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the~     post-remission therapy comparison.~   "
243806|NCT00363012|"~     RATIONALE: Studying the immune response to a vaccine made from HER2/neu protein may help~     doctors plan better treatment for patients with breast cancer that overexpresses HER2.~      PURPOSE: This clinical trial is studying the immune response in patients who have undergone~     vaccine therapy for stage III or stage IV breast cancer that overexpresses HER2.~   "
243807|NCT00362999|"~     The hypothesis to be proven is that histamine iontophoresis with measurement of microvascular~     blood flow by laser Doppler flowmetry can be used as a reliable marker to characterize the~     normal microvascular cutaneous response to histamine.~   "
243808|NCT00362986|"~     RATIONALE: Topical sunscreen may be effective in preventing skin rash caused by treatment~     with drugs such as erlotinib or cetuximab. It is not yet known whether topical sunscreen is~     more effective than a placebo in preventing skin rash in patients receiving drugs such as~     erlotinib or cetuximab for cancer.~      PURPOSE: This randomized phase III trial is studying topical sunscreen to see how well it~     works compared with a placebo in preventing skin rash in patients receiving drugs such as~     erlotinib or cetuximab for cancer.~   "
243809|NCT00362973|"~     RATIONALE: Diagnostic procedures, such as PET scans, may help in learning how well hormone~     therapy and trastuzumab work to kill breast cancer cells and allow doctors to plan better~     treatment.~      PURPOSE: This clinical trial is studying how well PET scans work in assessing response to~     treatment in patients receiving hormone therapy or trastuzumab for breast cancer.~   "
243810|NCT00362960|"~     Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function~     and inflammatory markers in patients with diabetic nephropathy~   "
243811|NCT00362947|"~     The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low~     molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so~     far do not give clear indications of the optimal dose and duration of treatment. This study~     aims to evaluate whether an intermediate therapeutic dose of LMWH (parnaparin) is more~     effective than a prophylactic dose and also to assess whether 10 rather than 30 days are~     sufficient for treatment.~   "
243812|NCT00362934|"~     Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both~     hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary~     mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall~     objective of the study is to compare the efficacy and safety of combining fenofibrate and~     simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of~     cardiovascular diseases.~   "
243813|NCT00362921|"~     RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and O6-benzylguanine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving Gliadel wafer together with~     O6-benzylguanine works in treating patients with recurrent glioblastoma multiforme.~   "
243814|NCT00362908|"~     The metabolic syndrome consists of five concurrent conditions which increase risk of heart~     disease, stroke, and diabetes. Persons with the metabolic syndrome usually have high~     triglyceride and low HDL levels and are overweight. Low fat, high carbohydrate diets may not~     provide the same cholesterol-lowering benefits to obese individuals as they do to non-obese~     individuals. The purpose of this study is to compare the effects of a low fat, high~     carbohydrate diet versus a moderate fat, moderate carbohydrate diet on the heart, blood~     vessels, and cholesterol levels in individuals with metabolic syndrome.~   "
243815|NCT00362895|"~     The purpose of the study is to determine the amount of study medication that moves from the~     front of the eye into the fluid at the front of the inside of the eye.~   "
243816|NCT00362882|"~     This trial is studying two different schedules of docetaxel and bortezomib to compare how~     well they work in treating patients with progressive or recurrent non-small cell lung cancer.~     Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     docetaxel together with bortezomib may kill more tumor cells~   "
243817|NCT00362869|"~     Enteroaggregative E. coli (EAEC) is a bacterium that can cause diarrhea. The purposes of this~     study are to: determine how much EAEC is needed to cause diarrhea in a healthy person,~     determine if a genetic factor is important in causing diarrhea, and to see how the body's~     defenses control EAEC. Participants include 25 healthy adults, ages 18-40. Volunteers will be~     assigned to 1 of 4 dose levels in groups of 5 volunteers each. One volunteer in each group~     will receive a sodium bicarbonate placebo solution. Volunteers will be admitted to the~     University Clinical Research Unit for up to 8 days. Volunteers will receive therapy with~     levofloxacin to treat the infection either once they develop diarrhea or at Day 5 if they~     remain asymptomatic. Study procedures will include saliva, blood, and fecal sample~     collection. An optional study procedure will include an intestinal biopsy. Participants will~     be involved in study related procedures for up to 223 days.~   "
243818|NCT00362856|"~     This study was run to determine the safety, tolerance, and efficacy of multiple doses of~     larazotide acetate in subjects with celiac disease following a gluten challenge.~   "
243819|NCT00362843|"~     Biosynthesis of proteins is essential for growth and continued maintenance of the entire~     neuron including axons, dendrites, and synaptic terminals, and it is clearly one of the~     important biochemical processes underlying adaptive changes in the nervous system. Studies in~     experimental animals with the quantitative autoradiographic L [1 (14)C]leucine method have~     demonstrated a number of the physiological and pathological conditions in which changes in~     regional rates of cerebral protein synthesis (rCPS) occur.~      We have recently developed the first fully quantitative method for determining rCPS with~     positron emission tomography (PET). The PET method was adapted from the autoradiographic L [1~     (14)C]leucine method; it uses L [1 (11)C]leucine as the PET tracer, dynamic scanning, and a~     kinetic modeling approach for quantification. This method was validated in nonhuman primates~     by comparison of PET measurements with those based on established biochemical and~     autoradiographic techniques.~      The objective of the present study is to examine the degree to which changes in rCPS in human~     subjects can be quantified with the L [1 (11)C]leucine PET method. We propose three studies~     to be carried out sequentially. In Part I we will establish the L-[1-(11)C]leucine PET method~     in human subjects. In Part II we will measure rCPS in normal control subjects in two states:~     awake and under deep sedation/general anesthesia with propofol. A difference in rCPS between~     these two states may indicate that we can detect activity-dependent protein synthesis with~     the PET method. In Part III we will study subjects with fragile X syndrome. This patient~     group was chosen since the affected gene in fragile X syndrome codes for a protein that is~     thought to be a negative regulator of message translation. Thus an effect on protein~     synthesis may be very close to the underlying genetic abnormality in fragile X syndrome.~     Regionally selective increases in rCPS have been found in studies in a mouse model of this~     disease.~      The present study will establish the sensitivity of the L [1 (11)C]leucine PET method to~     detect changes in rCPS in human subjects. A quantitative and sensitive method to measure rCPS~     with PET will augment the tools available for investigating the brain and its regional~     adaptive responses. Ultimately the method may have widespread applications, not only for the~     study of normal development and plasticity but also in clinical medicine, e.g., in the~     investigation of disorders of brain development, recovery from brain injury, and~     neurodegenerative diseases.~      SPECIFIC AIMS~        1. <TAB>Establish the L-[1-(11)C]leucine PET method for measurement of rCPS in human~          subjects. Evaluate the optimal scan time and the variability of the measurement in an~          individual.~        2. <TAB>Determine the effect of deep sedation with propofol on rCPS in normal human~          subjects. We will use the [1-(11)C]leucine PET method to evaluate lambda, i.e., the~          fraction of the precursor pool for protein synthesis that is derived from arterial~          plasma, and rCPS in the same subjects under awake and deep sedation conditions.~           I)<TAB>Hypothesis 1a. Deep sedation with propofol has effects on rCPS.~           II)<TAB>Hypothesis 1b. Deep sedation with propofol has effects on values of lambda.~        3. <TAB>Assess the sensitivity of the [1-(11)C]leucine PET method to detect differences in~          rCPS in subjects with fragile X syndrome.~      I)<TAB>Hypothesis 3a. There are regionally selective changes in rCPS in subjects with fragile~     X syndrome compared with age-matched healthy controls. Regions affected include hippocampus,~     thalamus, hypothalamus, amygdala, and frontal and parietal cortex.~      II)<TAB>Hypothesis 3b. In centrum semiovale, cerebellum, striatum and occipital and temporal~     cortex rCPS are unchanged in subjects with fragile X syndrome compared with age-matched~     healthy controls.~      III)<TAB>Hypothesis 3c. Values of lambda in the brain as a whole and in the regions examined~     are unchanged in subjects with fragile X syndrome compared with age-matched healthy controls.~      IV) Hypothesis 3d. The average rate of protein synthesis in the brain as a whole is unchanged~     in subjects with fragile X syndrome compared with age-matched healthy controls.~   "
243821|NCT00362817|"~     Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin~     and temozolomide significantly affects the response rates, or size of disease, in patients~     with brain metastases, originating from cancer in other parts of the body, compared to~     patients who have already been treated with radiation. Survival, causes of death, recurrence~     of disease in the central nervous system, toxicity, and quality of life will all be measured~     as secondary objective in this study.~   "
243822|NCT00362804|"~     Purpose of Study:~      A) To improve outcome in large population of antipsychotic patients with schizophrenia or~     schizoaffective who are only partial responders B) To increase understanding of pharmacology~     and mechanisms of action underlying antipsychotic effect~      Hypothesis/Objectives of the Study:~      Tetrabenazine, through its pre-synaptic action, should augment the post-synaptic effects of~     an antipsychotic.~      Background and Rationale for the study:~      Preliminary evidence that other amine-depleting agents e.g., reserpine, can induce such an~     effect~   "
243823|NCT00362791|"~     The efficacy of counseling to prevent infection with the human immunodeficiency virus (HIV)~     and other sexually transmitted diseases (STDs) has not been definitively shown. This~     multi-center randomized controlled trial (Project RESPECT) sought to compare the effects of 2~     interactive HIV/STD counseling interventions with didactic prevention messages typical of~     current practice.~      A total of 5758 STD clinic patients were enrolled from 5 public STD clinics (Baltimore, Md;~     Denver, Colo; Long Beach, Calif; Newark, NJ; and San Francisco, Calif) between July 1993 and~     September 1996. Eligible participants were heterosexual, HIV-negative patients aged 14 years~     or older who came for full STD examinations. Using a block design, participating men and~     women were randomzied separately to 1 of 3 individual face-to-face interventions. Arm 1~     received enhanced counseling consisting of 4 interactive counseling sessions based on the~     Theory of Reasoned Action and Health Belief Model. Arm 2 received brief counseling,~     consisting of 2 interactive risk-reduction sessions based on CDC's client-centered counseling~     model. Arms 3 and 4 each received 2 brief didactic messages about HIV/STD prevention messages~     typical of current care at that time. Participants assigned to Arms 1, 2, and 3 were actively~     followed up after enrollment with questionnaires at 3, 6, 9, and 12 months and STD laboratory~     examinations and tests at 6 and 12 months. An intent-to-treat analysis was used to compare~     interventions. Arm 4 participants were followed passively to determine potential effects of~     active study follow-up.~      The main outcome measures were self-reported condom use and new diagnoses of STDs (gonorrhea,~     chlamydia, syphilis, HIV) defined by laboratory tests.~      Results: At the 3- and 6-month follow-up visits, self-reported 100% condom use was higher~     (P<.05) in both the enhanced counseling and brief counseling arms compared with participants~     in the didactic messages arm. Through the 6-month interval, 30% fewer participants had new~     STDs in both the enhanced counseling (7.2%; P = .002) and brief counseling (7.3%;P=.005) arms~     compared with those in the didactic messages arm (10.4%). Through the 12-month study, 20%~     fewer participants in each counseling intervention had new STDs compared with those in the~     didactic messages arm (P = .008). Consistently at each of the 5 study sites, STD incidence~     was lower in the counseling intervention arms than in the didactic messages intervention arm.~     Reduction of STD was similar for men and women and greater for adolescents and persons with~     an STD diagnosed at enrollment.~      Subset analyses found that~      Based on these results, we conclude that short counseling interventions using personalized~     risk reduction plans can increase condom use and prevent new STDs. Effective counseling can~     be conducted even in busy public clinics.~   "
243824|NCT00362778|"~     Hyperglycemia at admission has been associated with bad prognosis in patients with acute~     myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has~     been evaluated in diabetic patients admitted to intensive care units. The aim of our study~     was to assess the short-term effects and the safety of strict glycemic control in subjects~     with AMI and hyperglycemia without a previous history of diabetes.~   "
243825|NCT00362765|"~     Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic~     patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo,~     fenofibrate, metformin, or metformin and fenofibrate combination.~   "
243826|NCT00362752|"~     The hepatopulmonary syndrome (HPS)and pre-HPS is a disease seen in patients with chronic~     liver disease, whereby patients develop dilations in the blood vessels of the lungs,~     resulting in low oxygen levels and shortness of breath.~      In this study, each HPS and pre-HPS subject will be treated with a commonly used antibiotic~     called norfloxacin (approved for use in the treatment of gonorrhea, prostatitis and urinary~     tract infections) for a 4-week period. In order to ensure that any observed improvement was~     indeed due to norfloxacin, each subject will also be treated with a separate 4-week course of~     an identical placebo. There will also be a 4 week wash-out period (no study~     medication/placebo) between the 2 courses of treatment.~      The primary aim of the study will be to measure improvements in oxygen levels while on~     norfloxacin, although a number of secondary parameters will also be followed.~   "
243827|NCT00362739|"~     This is a research study where researchers are collecting blood to evaluate the genetic~     characteristics of individuals with chronic lung diseases, including asthma, chronic~     obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, and lung~     cancer.~   "
243828|NCT00362726|"~     The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD~     and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of~     RGZ in healthy subjects.~   "
243829|NCT00362713|"~     The purpose of this study is to learn if ipilimumab can be given safely at two different~     doses given to patients with urothelial cancer who are going to have surgery as part of their~     treatment. The immunological effectiveness of ipilimumab will also be studied.~   "
243830|NCT00362700|"~     The purpose of this study is to determine the safety and antiviral activity of Clevudine,~     when retreated to patients previously treated with Clevudine~   "
243831|NCT00362687|"~     Many patients who already harbor drug-resistant HIV require interruption of HAART due to poor~     compliance, poor quality of life, toxicity or development of resistance. In these patients~     interruption of HAART has a negative impact on patient immune status due to the reemergence~     of wild-type virus which is in general more pathogenic than HIV isolates containing~     resistance mutations. There is a need for bridging antiretroviral regimens that might~     prolong time off conventional HAART whilst waiting for a new regimen that is either fully~     suppressive or less toxic or less demanding for the patient.~   "
243832|NCT00362674|"~     The purpose of this study is to evaluate the durability of antiviral activity in chronic~     hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303~     trial.~   "
243833|NCT00362661|"~     The aim of this prospective, double-blind, placebo-controlled, cross-over study is to~     determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic~     stress disorder.~   "
243834|NCT00362648|"~     The purpose of the current study is to evaluate whether the vaccine is effective,~     well-tolerated and immunogenic among infants in developing countries.~   "
243835|NCT00362635|"~     The purpose of this study is to compare the efficacy and safety of 48-week treatment with~     Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.~   "
243836|NCT00362622|"~     To determine the association between medical, demographic, socioeconomic, and therapeutic~     differences on compliance with topical glaucoma therapy using the Travalert device.~   "
243838|NCT00362596|"~     Herpes infection is an important co-factor in HIV transmission. A recent meta-analysis~     demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission.~     Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission. We~     are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir~     suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes~     Simplex Virus Type-2 (HSV-2) in Thailand.~   "
243839|NCT00362583|"~     Primary objectives:~        -  To confirm the efficacy of intranasal fentanyl titrated to doses 50, 100 or 200 µg for~          treatment of breakthrough pain (BTP) in cancer patients~        -  To establish long-term safety of treatment with intranasal fentanyl~      Secondary objectives:~      - To explore the relationship between dose of background opioid treatment and titrated~     fentanyl dose~   "
243840|NCT00362570|"~     Rationale:~      Standard therapy for anaplastic oligodendrogliomas and mixed oligoastrocytomas includes~     radiation and chemotherapy. However, due to the potential long-term central nervous system~     toxicity from radiation, researchers speculate that it may be better to reserve radiation~     therapy for progressive disease. In addition, some patients with anaplastic oligodendroglioma~     and mixed oligoastrocytoma have unusually chemosensitive tumors. Previous research indicates~     that brain tumor patients with a deletion of the 1p chromosome have a higher response to the~     chemotherapy drug temozolomide.~   "
243841|NCT00362557|"~     Any patient already receiving a scheduled MR scan of the body for any clinical indication~     will be eligible for this program. If patients agree to participate in this program, it would~     require only a slightly longer examination time. This time would vary according to the body~     area/organ being visualized but would not exceed 30 minutes over the length of the clinical~     examination. Volunteers are eligible if they are willing to undergo an MR examination.~      Patients would not be required to make any additional visits beyond their~     clinically-indicated visits. The study duration would vary according to the body area/organ~     visualized but would not exceed 30 minutes over the length of the clinical examination.~     Volunteers would be required to keep one study appointment to include one MR imaging~     examination.~      There will be no interruption to the standard care given to patients who participate in this~     trial since the clinical portion of their examination will be completed prior to the study~     portion of the exam.~   "
243842|NCT00362544|"~     This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome~     loading dose regimen, in a weekly administration schedule, during the aplastic phase~     following induction or consolidation chemotherapy for acute leukaemia, and during the initial~     phase of allogeneic stem-cell transplant, which are both high risk periods as far as severe~     fungal infections development is concerned.~   "
243843|NCT00362531|"~     Idiopathic membranous nephropathy (IMN) is one of the most common forms of nephrotic syndrome~     (NS) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs~     especially cyclophosphamide or cyclosporine. Tacrolimus, a new immunosuppressive agent, was~     proved to be effective in treating refractory NS. Whether it is effective in IMN has not been~     reported. We therefore undertook a multi-center, controlled study to investigate the efficacy~     and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients~     with idiopathic membranous nephropathy and nephrotic syndrome.~   "
243844|NCT00362518|"~     The proposed study will examine the hypothesis that vitamin C and vitamin E given to type 2~     diabetic individuals will provide effective anti-inflammatory, anti-thrombotic, and~     anti-oxidative atherosclerotic protection when administered at the optimal dose as determined~     by surrogate markers of inflammation, hypercoagulability, and oxidation.~   "
243845|NCT00362505|"~     The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24~     weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up~     period~   "
243846|NCT00362492|"~     The purpose of this study is to determine whether stopping Low Molecular Weight Heparin~     (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators~     select patients without proximal thromboembolism assessed by bilateral venous ultrasound~     examination 7-10 days after surgery. the investigators hypothesis is that stopping~     thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to~     prevent post-surgery complications in this population.~   "
243847|NCT00362479|"~     This is an open-label, single treatment study. All subjects will receive 6 months of oral~     contraceptive therapy with DR-1021. Study participants will receive physical and~     gynecological exams, including Pap smear. During the study, all participants will be required~     to complete a diary.~   "
243848|NCT00362466|"~     The purpose of this clinical research study is to compare the rate of complete cytogenetic~     response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase~     CML patients. The safety of this treatment will also be studied.~   "
243849|NCT00362453|"~     The purpose of this study was to compare the safety and effectiveness of Tai Chi with an~     Attention Control intervention consisting of a stretching and wellness education program~     involving 40 patients with osteoarthritis (OA) of the knee. We hypothesized that the~     participants receiving Tai Chi would show greater improvement in knee pain, physical and~     psychological functioning, and health-related quality of life than participants in the~     Attention Control group, and that the benefit would be mediated by effects on muscle~     function, musculoskeletal flexibility and mental health.~   "
243850|NCT00362440|"~     The purpose of this study is to determine whether patients with HIV lipodystrophy (fat~     wasting) benefit from taking the combination of two drugs, one insulin sensitizer (either~     metformin or pioglitazone, both diabetes drugs) and leptin (a natural hormone produced by~     your fat cells). Our hope is that they will improve sugar and fat metabolism and positively~     affect the body fat changes you have noticed while taking HAART.~   "
243851|NCT00362427|"~     PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of~     injections during the first 2 years of life while providing a complete course of immunization~     against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium~     diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.~      Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition~     enhancement to the hepatitis B component when administered concomitantly with Prevnar®~      Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered~     concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for~     routine infant vaccination in Canada.~   "
243855|NCT00362375|"~     The purpose of this program evaluation is to determine whether the Health Love Workshop, a~     group-level HIV behavioral intervention, reduces HIV-related sex risk behaviors and increases~     HIV protective behaviors of African American women and women of African descent. The intent~     of this program is to support an evaluation of the efficacy of the intervention and to~     provide feedback to the implementing organization to increase intervention effectiveness.~   "
243856|NCT00362362|"~     This study will collect blood samples from patients with primary lateral sclerosis (PLS) and~     amyotrophic lateral sclerosis (ALS) to be used for research on genetic causes of motor neuron~     diseases and other neurological disorders.~      Patients 18 years of age and older with PLS or ALS may be eligible for this study. Candidates~     are screened with a medical history, physical examination and diagnostic tests.~      Participants provide a blood sample. The sample, along with masked (anonymous) medical and~     family history information are sent to the NINDS Respository at the Coriell Cell Repositories~     in Camden, NJ. This facility collects, stores and distributes medical research information~     and cell cultures and DNA samples to researchers at hospitals, universities and commercial~     organizations. The blood sample has an identification number that is unrelated to any~     identifying information for the patient and cannot be tracked back to the patient.~   "
243857|NCT00362349|"~     Idiopathic Thrombocytopenic Purpura (ITP) is an autoimmune bleeding disorder characterised by~     isolated low platelet counts. The aim of treating patients with ITP is to increase the~     platelet concentration and reduce the risk of bleeding. A number of controlled multi-centre~     studies have demonstrated that Intravenous Immunoglobulin (IVIg) therapy produces a rapid~     rise in platelet counts within a 24 to 72 hour period. This study will evaluate the efficacy~     and safety of Ig NextGen 10% in adult patients with ITP.~   "
243858|NCT00362336|"~     The purpose of this study is to document the immunological response to the investigational~     hexavalent vaccine at the 6, 10, and 14 weeks schedule~      The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined~     vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric~     and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B~     (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6,~     10, and 14 weeks) with no HB vaccination at birth.~      The secondary Objectives are:~      To describe the safety in terms of any adverse events in the first 28 days after each~     injection and any serious adverse events during the entire trial.~      To describe Immunogenicity after the primary series and prior to and after a booster~     vaccination.~   "
243859|NCT00362323|"~     To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a~     statin and receiving metformin, the superiority of a fixed combination of fenofibrate and~     metformin vs metformin alone on TG and additionally, if the superiority on TG is established,~     to demonstrate the superiority on HDL-C~   "
243860|NCT00362310|"~     Recent studies have described a reduced incidence or the regression of Kaposi's sarcoma (KS)~     in HIV-infected patients treated with the highly active anti-retroviral therapy (HAART) that~     contains at least one inhibitor of the HIV protease (HIV-PI) such as Indinavir. Experimental~     studies have shown that part of the anti-KS actions of HIV-PI are not related to their~     antiretroviral actions, but, at least in part, to their capability of blocking angiogenesis~     and tumor growth.~      This study will be conducted on HIV-negative (classical) KS patients to prove that Indinavir~     has anti-angiogenic and anti-KS effects in humans independently of its antiretroviral~     activity.~   "
243861|NCT00362297|"~     The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir~     compared to valacyclovir for reduction of asymptomatic genital shedding in persons with~     genital herpes.~      The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by~     blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at~     least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and~     willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females~     only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an~     effective form of birth control.~      Involvement in the study will last 15-weeks and you will be asked to visit the clinic every~     2-weeks. At each visit, you will be given medication to take daily (either valacyclovir or~     acyclovir; you will receive both medications at some point during this study). There will be~     a total of 9 study visits and each visit will last approximately 30 minutes. We will ask that~     you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday~     during the study. Each daily home swab will take less than 3 minutes to perform.~   "
243862|NCT00362284|"~     The purpose of this study is to determine the effectiveness of a comprehensive counseling and~     support intervention for people who care for parents with Alzheimer's disease (AD) or other~     dementias on outcomes such as stress, depression and ability to postpone or avoid nursing~     home placement.~   "
243863|NCT00362271|"~     The purpose of this clinical research study is to learn whether aripiprazole has effect on~     the steady-state pharmacokinetics of venlafaxine in healthy subjects. The safety and~     tolerability of aripiprazole and venlafaxine co-administration will also be studied.~   "
243864|NCT00362258|"~     -  To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg~          and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.~        -  To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline~          (if any at the inclusion visit) in this population.~        -  To demonstrate the safety of Irbesartan in this population.~   "
243865|NCT00362245|"~     The limited available data precludes establishing an antibiotic regimen in patients suffering~     from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the~     disposition of Amikacin administered intrathecally will enable to propose rational treatment~     of these patients.~   "
243866|NCT00362232|"~     The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is~     safe and prevents blood clot which may form after a knee replacement operation.~   "
243893|NCT00361868|"~     Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients~     with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed~     combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of~     rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is~     superior to that of rosiglitazone.~   "
243867|NCT00362219|"~     The management of pain endured by patients after skin grafting is complex. Pain is the single~     most distressing symptom but as it is difficult to manage, it is often under-treated. These~     patients may experience pain from two types of wound: the original injury and from~     skin-donor sites, areas of healthy skin from which skin is surgically removed and used to~     cover the original injury. As the section of skin which is removed is standardized, the wound~     created at the donor site is uniform and so provides a model of an acute wound.~      Opioids (such as morphine) are the backbone of treating the moderate to severe pain~     experienced by any patient. But due to their potentially severe side effects and that some~     patients do not experience sufficient relief from the treatment, optimal treatment schedules~     are still being sought after.~      Topically applied morphine has provided effective and safe analgesia in several clinical~     models. We, therefore, wish to apply this treatment modality onto skin-graft donor wounds. If~     found to be effective this could be an appealing non-invasive method to treat the pain of~     this type of wound.~   "
243868|NCT00362206|"~     Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both~     hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary~     mechanisms and can be coadministered to patients with mixed hyperlipidemia.The overall~     objective of the study is to compare the efficacy and safety of combining fenofibrate and~     simvastatin versus pravastatin monotherapy in patients with mixed hyperlipidemia at risk of~     cardiovascular diseases.~   "
243869|NCT00362193|"~     This purpose of this study is to determine the optimal frequency of maintenance intervention~     needed to prevent glycemic relapse.~   "
243870|NCT00362180|"~     This study will assess what, if any, effect that ISIS 301012 (mipomersen) has on liver~     triglyceride content in multiple groups of subjects with varying degrees of risk for hepatic~     steatosis. In order to enroll subject groups with varying degrees of risk, the study has~     included multiple cohorts (Cohorts A-G). Additions and removal of cohorts has been~     accomplished with protocol amendments.~   "
243871|NCT00362167|"~     This study offers evaluation and treatment for patients with a spectrum of acute and chronic~     pain syndromes. The protocol is not designed to test new treatments; rather, patients will~     receive current standard of care treatments. The purposes of the study are: 1) to allow~     physicians in NIDCR's Pain and Neurosensory Mechanisms Branch to gain more knowledge about~     treating acute and chronic pain and possibly identify new avenues of research in this area;~     and 2) to establish a pool of patients who may be eligible for new studies as they are~     developed. (Participants in this protocol will not be required to join a new study; the~     decision will be voluntary.)~      Patients 12 years of age and older with an acute or chronic pain syndrome may be eligible for~     this study. Women of childbearing potential and women who are pregnant or breastfeeding will~     not be enrolled in this study, drugs may have unknown or untoward side effects on the baby.~      Participants will provide a medical history, as well as occupational and social information.~     They will have a standard neurological examination, including a test of cognitive (thinking)~     abilities, muscular function, reflexes and sensory examination. The latter involves testing~     with a pin placed on the surface of the skin. Participants will also have routine blood tests~     and will fill out questionnaires on their daily functioning and psychological well being.~     Additional procedures may include magnetic resonance imaging (MRI) scans and possible~     referral to a psychiatrist for evaluation of depression or emotional difficulties.~      Participants will be treated according to their individual pain problem. Treatments may~     include medicines, exercises, physical therapy, nerve blocks and dietary changes. Medicines~     given in this study are commonly used by doctors to treat pain, but for many, there is little~     research to back up their use. This study will provide information on the effectiveness of~     these treatments. Participants will keep a daily log in which they rate their pain, record~     any procedures they undergo outside the study, such as injections and exercises, and record~     medication side effects.~      Participation in the study will end based on the researcher's assessment of the patient's~     response to treatment. The study doctor will provide the patient's referring doctor a report~     of medications or other treatments used in the study. At the last visit, patients will fill~     out the same questionnaires they filled out during the first visit.~   "
243872|NCT00362141|"~     The purpose of this study is to determine whether levetiracetam is safe and well tolerated by~     patients while suffering a status epilepticus. Levetiracetam is added to the standard~     treatment of patients with this disease.~   "
243873|NCT00362128|"~     The Chinese population is currently the fastest growing ethnic group in New York City (NYC).~     Research has shown that Chinese immigrants living in NYC have higher rates of cardiovascular~     disease (CVD) than individuals in China. This study will evaluate the effect that~     acculturation has on health habits and CVD risk factors in Chinese immigrants living in NYC.~   "
243874|NCT00362115|"~     The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan~     medoxomil, once daily (QD), in individuals with hypertension.~   "
243875|NCT00362102|"~     To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects~     with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease~     to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance)~     previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.~   "
243876|NCT00362089|"~     Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until~     4 months post-partum (pp) in comparison to a control group, who only gets information about~     adequately healthy nutrition during pregnancy and lactation.~      The amount of fat in newborns is measured through skinfold thickness, ultrasound, and~     magnetic resonance imaging (MRI).~      It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC~     PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic~     acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue~     development in the first year of life.~   "
243877|NCT00362076|"~     This study is concerned with psychological and physiological development in infants.~     Specifically, researchers are interested in when and how babies are able to group similar~     objects, like animals or vehicles, into the same category. This study will investigate~     whether motion aids in the categorization process and allows for earlier demonstration of~     this competency.~      Previous studies have demonstrated that the ability to categorize stationary objects or~     images of objects, is present by 6 months of age. This study is made up of three experiments~     to test:~        1. The infant's ability to categorize photographic stimuli.~        2. The infant's ability to categorize moving stimuli.~        3. The infant's ability to transfer knowledge from moving to photographic stimuli.~      Initially, the abilities of 3- and 6-month-old infants will be compared. It is also possible~     that 9-month-old infants will be tested. Data will consist of looking at time measures (level~     of attention to displays) and heart rate. The ability of infants to transfer category~     knowledge will support the view that motion is a source of information for object~     categorization.~   "
243915|NCT00361569|"~     This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to~     compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream~     on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or~     oophorectomy.~   "
243878|NCT00362063|"~     The purpose of the proposed study is to investigate the effects of rhGH treatment on glucose,~     protein and fat metabolism in GHD children. Specifically, the investigators will measure the~     rates of glucose production, gluconeogenesis, glycogenolysis, insulin sensitivity and~     glucagon response before and after treatment with rhGH. In addition, the investigators will~     study changes in protein and fat metabolism pre and post rhGH therapy in children with GHD.~     The findings in the GHD children will be compared to those of a control group of age and sex~     matched healthy children.~      Hypotheses: H1- The fraction of glucose derived from gluconeogenesis is decreased and that~     from glycogenolysis is increased in the post-absorptive state in untreated GHD children when~     compared to healthy children. H2- Treatment with rhGH will not change the overall glucose~     turnover but will normalize the abnormal partitioning of gluconeogenesis and glycogenolysis~     in GHD children. H3- GH replacement will reduce urea production and increase estimates of~     protein synthesis, thus optimizing the availability of amino acids for growth. H4- Untreated~     children with GHD after an overnight fast will have an increased glucagon challenge response~     that will decrease after 8 weeks of treatment with rhGH.~      Specific Aims: In healthy and newly diagnosed GHD children the investigators will: 1. Measure~     the Glucose Production Rate (GPR) 2. Determine the fraction of glucose derived from~     gluconeogenesis and glycogenolysis 3. Estimate insulin sensitivity 4. Measure proteolysis and~     protein oxidation 5. Determine glucagon challenge response after an overnight fast. The~     above-mentioned parameters will be re-evaluated in the children with GHD after 8 weeks of~     rhGH therapy.~   "
243879|NCT00362050|"~     The trial will identify the best dose of the synthetic peroxide RBx11160 to treat~     uncomplicated malaria. Patients will be treated over 7 days with daily doses of 50, 100 or~     200 mg RBx11160.~      The study is designed to assess the antimalarial activity and safety of 3 dose levels of RBx~     11160 administered once daily for 7 consecutive days. The primary endpoint will be the time~     to 90% parasite clearance. In future regulatory studies, RBx 11160 is likely to be~     administered in combination with another antimalarial agent since the development plan~     follows the current recommendation of WHO for the treatment of uncomplicated malaria.~     However, it is critical to gather data on RBx 11160 when used as monotherapy in adult~     patients suffering from acute uncomplicated P. falciparum malaria. In malaria-endemic~     regions, an adult population is defined on the basis of immune status rather than the legal~     age of consent. Thus, patients as young as 13 years of age can be enrolled provided consent~     has been obtained from a legal guardian in accordance with local practices and regulations.~     This study will be conducted in compliance with International Conference on Harmonization~     (ICH) Good Clinical Practice (GCP).~   "
243880|NCT00362037|"~     -  To evaluate Blood Pressure (BP) reduction to the targeted values (BP ≤ 140/90 mm Hg in~          non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients).~        -  To emphasize and to evaluate the benefit of Irbesartan in the reduction of left~          ventricular mass index in hypertensive patients with left ventricular hypertrophy.~        -  To demonstrate safety of Irbesartan in this population.~   "
243881|NCT00362024|"~     MK0952 is a phosphodiesterase type IV (PDE4) inhibitor in development for improvement of~     cognitive impairment in mild-to-moderate Alzheimer's disease.~   "
243882|NCT00362011|"~     The purpose of this study is to determine whether the addition of Salvia hispanica L. Alba~     (Salba) to the conventional treatment for diabetes is associated with improvement in major~     and emerging cardiovascular risk factors in people with type 2 diabetes.~   "
243883|NCT00361998|"~     Our guidelines in the community recommend the use of NM for the treatment of women with~     community acquired UTI. While the length of treatment for uncomplicated cystitis with~     quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not~     sufficient papers that establish the optimal length of treatment with NM in this population.~     The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the~     treatment of women with uncomplicated UTI.~   "
243884|NCT00361985|"~     The purpose of this study is to determine whether suppressing acid production by~     administration of daily proton pump inhibitors in the early post-operative period will reduce~     the gastrojejunal anastomosis stricture rate in patients undergoing laparoscopic gastric~     bypass surgery for morbid obesity.~   "
243885|NCT00361972|"~     This study will evaluate how heartburn may lead to different types of inflammation in one's~     airways. Additionally, the study will determine whether aggressive treatment of heartburn~     results in improvement in both symptoms of heartburn and asthma but also in documented~     improvement in airway inflammation as determined by biopsy. The results of this study will be~     important in directing future research into the relationship between heartburn and asthma and~     may provide a clue whether certain subtypes of asthma may be caused primarily by~     gastroesophageal reflux (GER).~   "
243886|NCT00361959|"~     This is a comparator study to assess the relative efficacy of the combination product~     fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations~     of chronic obstructive pulmonary disease (COPD) over a two year study interval.~   "
243887|NCT00361946|"~     To study postprandial metabolism in lean, obese and T2DM adolescents using a mixed meal~     challenge. Specifically we will be measuring the following parameters of postprandial~     metabolism: 1. Postprandial glucose and triglycerides excursions 2. Gastric emptying 3.~     Insulin, amylin, glucagon, GLP-1 and ghrelin secretion 4. Glucose Turnover rate~   "
243888|NCT00361933|"~     The purpose of the study is to learn whether people who are experiencing an MCD (multicentric~     Castleman's Disease) flare will improve after taking valganciclovir. MCD is a type of~     inflammatory disease associated with Human Herpesvirus 8 (HHV-8). Valganciclovir is FDA~     approved for treating a different type of Human Herpesvirus, but not approved for the~     treatment of HHV-8. It is therefore considered experimental in this study.~   "
243889|NCT00361920|"~     The hypothesis is that patients who demonstrate steroid resistant asthma by showing little or~     no improvement in lung function after a course of oral steroids have different cellular~     responses to steroids than patients who are steroid sensitive. These altered responses are~     the reason they demonstrate steroid resistance.~   "
243890|NCT00361907|"~     The purpose of this study is to determine the effect of Pulsatile Intravenous Insulin therapy~     on circulating blood markers. These blood markers are selected due to their correlation to~     and possible pathogenetic roles in vascular compromise and inflammatory malfunction in~     diabetic patients.~   "
243894|NCT00361855|"~     Certain types of cells located in bone marrow may help the body recover after an injury.~     These cells may be able to help the body repair heart muscle that has been damaged from a~     heart attack. NX-CP105 is a new investigational drug that is made up of these special types~     of bone marrow cells, which come from another person. NX-CP105 has not been approved for sale~     or general use by the Food and Drug Administration (FDA), and this study will be the first~     time that NX-CP105 is given to human beings.~      This study is being conducted to see if there are any side effects associated with with~     NX-CP105 and whether NX-CP105 may help the body repair heart muscle that has been damaged~     from a heart attack. Three different doses of NX CP105 will be tested in this study, starting~     with the lowest dose first.~      Patients who decided to participate in the study will have a heart catheterization procedure~     during which a narrow tube is inserted into an artery (type of blood vessel) in the groin and~     passed to the heart. A second narrow tube will be inserted into a vein (type of blood vessel)~     in the groin and passed to your heart. A device will be passed through the second tube. This~     device will be used to inject NX-CP105 cells directly into your heart muscle.~   "
243895|NCT00361842|"~     The purpose of this study is to determine whether CPX-1 is effective in patients with~     advanced colorectal cancer who have already received chemotherapy that included the drug~     oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90~     minutes every two weeks.~   "
243896|NCT00361829|"~     Research and theory tend to agree when suggesting that certain activities done by mothers~     have both immediate and delayed consequences for children's mental development in the first~     years of life.~      The everyday interaction between an infant and a caregiver can be broken down into many~     categories. There are data linking both of these types of interaction to the mental~     development of children.~      The study will focus on the extent to which maternal characteristics (age, employment status,~     parenthood status, and birth order of the child) influence the relation between maternal~     social and didactic caregiving and the social and mental development of children.~      Mother-infant interaction will be observed when the infants are 5 months old.~      When the children are 20 months old, measures of toddler function (e.g., ability to play and~     language development) and maternal behavior (e.g., encouragement of attention to the~     environment and I.Q.) will be obtained.~      When the children are 48 months old, researchers will measure preschooler psychosocial~     functioning (e.g., I.Q., cognitive and social competencies) and maternal behavior (e.g.,~     scaffolding).~      Understanding the relation between children's experiences as infants, toddlers, and~     preschoolers and their eventual intellectual and social functioning is an essential part of~     normal developmental research.<TAB>~   "
243897|NCT00361816|"~     Approximately 15 percent of couples experience infertility, yet no abnormalities can be~     detected in the man or the woman. In a number of couples, their embryos unexpectedly slow~     down growth or stop growth completely. Some of these situations may be genetically~     determined. For instance, a portion of cases may be caused by poor egg quality related to~     genetic or functional deficiencies in heretofore unidentified human maternal effect genes. A~     model has been developed of such unexplained fertility by creating a mouse line lacking a~     critical maternal effect gene. (Maternal effect genes produce mRNA or proteins that~     accumulate in the egg and are required for normal early embryonic development.) This pilot~     project will test the hypothesis that a similar defect may be a cause of human infertility.~      Thirty cubic centimeters of blood will be collected from 40 women who have a clinical history~     consistent with a defective maternal effect gene. DNA from these blood cells will be examined~     and stored. Some of the blood cells will be treated so that they can be frozen and grown in~     the laboratory to produce more DNA in the future. If certain mutations are not found, that~     means that the prevalence of such mutations is less than 10 percent, and investigators may~     initiate another study with 100 women. If a common mutation is found in at least four~     patients, the investigators will seek to collect DNA from 150 normal fertile control women~     for comparison.~      This project is purely investigational; therefore, findings will not be shared with~     participants.~   "
243898|NCT00361803|"~     A multi-center, open label, single dose Phase I pharmacokinetic (PK) characterization of~     weekly IV (intravenous) topotecan given at 4mg/m2. 15 patients will be evaluated.~   "
243899|NCT00361790|"~     The purpose of this clinical research study is to learn whether aripiprazole has effect on~     the steady-state pharmacokinetics of escitalopram in healthy subjects. The safety and~     tolerability of aripiprazole and escitalopram co-administration will also be studied.~   "
243900|NCT00361777|"~     This study will test the accuracy of screening tests for Cushing s syndrome in overweight~     people with signs of the disorder. Cushing s syndrome is a rare disorder caused by excess~     production of the hormone cortisol. Patients may have various problems, such as weight gain,~     high blood pressure, diabetes, infections, mood problems, trouble concentrating, and~     increased blood clotting. These symptoms are seen in many other disorders as well,~     complicating the diagnosis. The reliability of tests currently used to diagnose Cushing s~     syndrome is not known. To test their accuracy, subjects in this study who test positive for~     Cushing s syndrome will be evaluated at NIH for 2 years to either confirm or refute the~     laboratory results.~      Patients between 18 and 75 years of age who are being treated at the George Washington~     University Weight Management Program (GWUWMP) may participate in this study. Candidates will~     be screened with a medical history, physical examination, measurement of body fat, blood~     tests, and oral glucose tolerance test. They will also complete a symptoms checklist and~     quality of life questionnaire.~      Participants will be tested for Cushing s syndrome with a saliva collection, 24-hour urine~     collection, and dexamethasone suppression test (DST). For the DST they will take 1 mg of~     dexamethasone at night and report to GWUWMP the next morning for a blood draw. All specimens~     blood, saliva, and urine will be tested for cortisol levels.~      People whose test results are abnormal will be seen at the NIH outpatient clinic for a~     medical history, physical examination, and blood tests; bedtime saliva collection; two~     24-hour urine collections; and a 2-day 2-mg DST, followed by administration of~     corticotropin-releasing hormone (CRH). CRH is a naturally occurring hormone that causes~     cortisol levels to rise. Pre-treatment with dexamethasone prevents CRH from causing an~     increase in cortisol in healthy people, but not in patients with Cushing s syndrome. For the~     2-day DST, the subject takes 0.5 mg dexamethasone every 6 hours for eight doses. Two hours~     after the last dose, CRH is injected through a catheter (thin plastic tube) inserted into an~     arm vein. Blood is drawn just before giving CRH to measure dexamethasone and cortisol levels~     and after giving CRH to measure cortisol levels.~      People whose test results are normal will not be seen further at NIH. Those with high~     cortisol levels will have repeat urine and saliva tests every 2 to 8 weeks for up to 24~     months, and a 1-mg DST every 3 months during routine clinic visits at GWUWMP. People whose~     increased cortisol is found to be due to another condition besides Cushing s syndrome will be~     referred for evaluation and possible treatment. Those diagnosed with Cushing s syndrome will~     have standard tests to identify the tumor causing the disorder, followed by standard medical~     and surgical treatment.~   "
243916|NCT00361556|"~     The primary purpose of this study is to compare the effectiveness on the disability of low~     back pain patients of The Back Book, The Back Guide, and a control intervention (generic~     recommendations on general health). Patients are divided into 3 groups:those who receive The~     Back Book (classic education), those who receive The Back Guide (cognitive behavioral~     education) and the control group). They are patients who consult a physician at the primary~     care consults of 14 different Health Centers in Spain. The sample size is 240 subjects.~   "
243901|NCT00361751|"~     Insulin resistance and hyperglycemia contribute to negative outcomes in burned patients. We~     will assess insulin sensitivity in traditional terms of glucose metabolism, and with regard~     to the responsiveness of both muscle and liver protein metabolism, in severely burned~     patients. Plasma free fatty acid (FFA) and tissue TG levels will be manipulated via~     inhibition of peripheral lipolysis with nicotinic acid or activation of plasma lipoprotein~     lipase activity with heparin, stimulation of tissue fatty acid oxidation and thus reduction~     of tissue TG with the peroxisome proliferate-activated receptor (PPAR) alpha agonist~     fenofibrate. Methodological approaches will include stable isotope tracer techniques to~     quantify kinetic responses of protein, glucose and lipid metabolism in vivo, quantification~     of intracellular stores of TG and glycogen by means of magnetic resonance spectroscopy (MRS),~     as well as quantitative analysis of tissue levels of active products of fatty acids, key~     intermediates of the insulin signaling pathway, glycogen, the enzyme activities of citrate~     synthase and glycogen synthase and the activity of the muscle mitochondria. These studies~     will clarify the physiological and clinical significance of the alterations of tissue lipid~     metabolism that occur after burn injury, thereby forming the basis for new therapeutic~     approaches not only in this specific clinical condition but in other clinical circumstances~     in which hepatic and/or muscle TG is elevated.~      We will investigate the general hypothesis that the accumulation of intracellular TG in liver~     and muscle either directly causes insulin resistance in those tissues or serves as an~     indictor of the intracellular accumulation of active fatty acid products, such as fatty acyl~     CoA and diacylglycerol, which in turn disrupt insulin action.~      The following specific hypotheses will be investigated:~        1. Intracellular TG is elevated in both muscle and liver in severely burned patients. The~          reduction of the fat in the liver and the insulin resistance will improve clinical~          outcomes, glucose and protein metabolism.~        2. The insulin signaling pathway, as reflected by phosphoinositol-3-kinase (PI3K) and PKC~          activity, is impaired in tissues with elevated TG.~        3. Fatty acids, or their active intracellular products, are the direct inhibitors of~          insulin action, rather than the tissue TG itself.~   "
243902|NCT00361738|"~     Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus~     also receiving metformin.~      Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma~     Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose~     (fasting and post-prandial), and also the safety and tolerability of AVE2268.~   "
243903|NCT00361725|"~     This is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis~     patients, 30 non-septic patients with organ failure, 30 healthy subjects.~      The only intervention is a venous blood sampling at the onset of the disease.~      The purpose of the study is to compare the PC pathway and expression and inflammatory genes~     between the 3 groups. The main hypothesis is that systemic inflammatory response and~     exacerbated coagulation activation are non specific of an infection as a triggering event.~   "
243904|NCT00361712|"~     During labor there is an increased production of inflammatory mediators called cytokines.~     Higher concentration of certain cytokines has been linked to adverse neonatal and maternal~     outcomes.~      Epidural analgesia is commonly performed after the parturient feels labor pain.~      We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can~     influence the production of cytokines.~   "
243905|NCT00361699|"~     Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in~     preventing recurrent vascular events from ischemic heart disease patients, whose mechanism~     consists in not only the reduction of serum lipid level but also anti-inflammatory effects.~     Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of~     other conventional risk factors. The present substudy examine whether such pleiotrophic~     effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be~     observed in the post-ischemic stroke patients who have already been registered in the~     J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.~   "
243906|NCT00361686|"~     Patients undergoing second trimester abortions will recieve either patient controlled~     analgesia with either remifentanyl or tramadol for pain alleviation.~      We beleive both to be equally effective for pain alleviation.~   "
243907|NCT00361673|"~     Cardiovascular disease (CVD) is one of the main causes of death in the United States.~     Research has shown that individuals who maintain an active lifestyle are less likely to~     develop CVD. This study will examine how neighborhood environments influence CVD risk factors~     of residents in and around the Stapleton community of Denver, Colorado.~   "
243908|NCT00361660|"~     The first purpose of this study is to determine how often people should practice motor skills~     to best improve the ability to use the affected arm and hand after stroke. The second purpose~     is to determine whether it is better to practice a lot of repetitions of a few tasks or a few~     repetitions of many tasks during motor rehabilitation for the arm and hand after stroke.~   "
243909|NCT00361647|"~     Prospective controlled randomized study. Aim of this study is to assess the feasibility and~     sensitivity of CT scanning of the thorax, abdomen and pelvis for the detection of occult~     cancer in patients with idiopathic venous thromboembolism. Patients presenting with acute~     idiopathic venous thromboembolism, free from already known cancer and in whom a routine~     battery screening has excluded the presence of cancer, are randomized to receive either a CT~     scanning of the thorax, abdomen and pelvis (completed by mammography if not already performed~     in the past year, and by gastroscopy and/or colonoscopy in patients with positive hemoccult)~     or a diagnostic programme freely decided by attending physicians. Patients of either group in~     whom the search for cancer is negative are followed-up for two years to register the~     development of clinically symptomatic malignant disease. The rate of cancer detection and~     that of cancer development are compared between the two study groups.~   "
243910|NCT00361634|"~     The purpose of this study is to assess whether DCE-MRI can detect changes of active disease~     in rheumatoid arthritis (RA) patients after 4, 8 and 12 weeks of etanercept.~   "
243911|NCT00361621|"~     The main purpose of this study is to begin to collect information and try to learn whether or~     not VELCADE, when added to standard chemotherapy with CHOP/Rituxan, works in treating~     patients mediastinal large B-cell lymphoma. Recent research has shown that this type of~     lymphoma shares features with Hodgkin's lymphoma, including the importance of a particular~     pathway in the tumor cells called the NF-kB pathway. VELCADE works in part by blocking this~     pathway.~   "
243912|NCT00361608|"~     This study observes the continuous measurement of breathing patterns, heart rate,~     restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the~     management of hypoglycemia in pediatric type I diabetes patients.~   "
243913|NCT00361595|"~     The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone~     mass after two years of treatment with Forteo, in postmenopausal women.~   "
243914|NCT00361582|"~     The purpose of this study is to evaluate in patients who are eligible for elective primary~     total or partial joint replacement of the hip or knee due to chronic osteoarthritis the~     efficacy (level of pain control) of CG5503 over 5 and 10 days compared with placebo, and to~     assess the safety and tolerability of multiple doses of CG5503 IR patients.~   "
243917|NCT00361543|"~     The aim of the project is to investigate the use of Raloxifene (a new form of estrogen) in~     the treatment of women with schizophrenia and schizoaffective disorder. Raloxifene is a~     Selective Estrogen Receptor Modulator (SERM), which means that it can affect the central~     nervous system (CNS) effects of estrogen (eg. improving emotional symptoms, memory,~     information processing and concentration), without adversely affecting reproductive~     tissue/organs such as breast, uterus and ovaries. The investigators are conducting a~     double-blind, placebo controlled, three month study comparing the psychotic symptom response~     of women with schizophrenia in both groups. One group will receive standard antipsychotic~     medication plus 120mg Raloxifene, while the second group will receive standard antipsychotic~     medication plus oral placebo.~      Hypothesis 1: That the women receiving adjunctive Raloxifene would have a quicker recovery~     from psychotic symptoms, as measured on the rating scales, compared with the women receiving~     adjunctive placebo.~      Hypothesis 2: That the Raloxifene group would have better cognitive improvement than the~     placebo group.~   "
243918|NCT00361530|"~     Carotid ultrasound can reveal the intima-media complex thickness(IMT), that has been reported~     to be a marker of atherosclerosis as well as a risk of cardiovascular events, and to be~     attenuated by 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins)~     . This substudy of J-STARS will observe the temporal profile of carotid IMT prospectively in~     the patients with prescription of pravastatin and the control.~   "
243919|NCT00361517|"~     Chemotherapy lowers the white blood cell count or weakens the immune system for a long time.~     This puts the patients at a high risk of getting a serious fungal infection of the internal~     organs or blood. One of these infections is caused by a mold called Aspergillus and can be~     life threatening. Usually doctors give preventive antifungal therapy to try to lower the risk~     of this infection. Despite this, patients are still at risk of getting fungal infection. This~     study is thus designed to test Galactomannan - a component of cell wall of Aspergillus and~     hence detect and treat fungal infection early.~   "
243920|NCT00361504|"~     The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at~     doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients~     with at least a 3-month history of low back pain, or pain caused by knee or hip~     osteoarthritis.~   "
243921|NCT00361491|"~     The purpose of the study is to evaluate the efficacy of SSR149415 in the treatment of Major~     Depressive Disorder, defined as a change from baseline to visit 7 in the Hamilton Depression~     Rating Scale.~      To evaluate the tolerability, safety and efficacy on disability and quality of life in~     patients with major depressive disorder.To evaluate plasma concentrations of SSR149415.~   "
243922|NCT00361478|"~     The study investigates the effect of the 'Mother and Baby' (M&B) program on the psychological~     health and well-being of new mothers 6-10 weeks following the birth of their baby. The M&B~     program is an 8-week program of group exercise and education sessions provided by various~     health professionals. The design of the study is a comprehensive cohort design, including a~     randomised controlled trial. The primary outcome measure is the Affect Balance Scale. The~     hypotheses are:~        1. The M&B program has a positive effect on new mothers' psychological health and~          well-being.~        2. The M&B program increases participation in regular physical activity.~        3. the M&B program benefits first time mothers more than women who have had more than one~          child.~   "
243923|NCT00361465|"~     Dystonia is a rare disease leading to a severe handicap. It can be of primary or secondary~     origin. It is characterized by sustained muscle contractions, frequently causing twisting and~     repetitive movements or abnormal postures. These disorders are believed to be caused by some~     dysfunction of the basal ganglia (BG) circuitry, but the mechanisms are largely unknown.~      A better understanding of the disorder requires significant improvements of its~     phenomenological description in relation to aetiology. We want to identify specific motor~     signatures of different forms of dystonia. To that aim, we will ask patients to perform~     movements of various complexities, while recording chronometric, kinematics and EMG data. The~     characteristics of the patients' movements will be compared to those of matched control~     subjects. We will examine abnormal co-activation in distal and proximal muscles to evaluate~     the characteristics of the loss of selectivity of the motor command in mobile vs. fixed~     dystonia. Consistency of the motor output patterns will be compared in three groups of~     patients. We will also study possible cognitive and limbic components of the disease,~     examining the influence of cognitive and emotional loads on movement production. Eventually~     we want to refine the criteria used to classify different forms of the disease, thus enabling~     clinicians to better predict the likely outcome of particular therapeutic procedures.~   "
243924|NCT00361452|"~     Bronchiolitis is a common disease of infancy and a main reason for infants' hospital~     admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory~     syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized~     epinephrine or albuterol has been largely debated for the past years. Most of the clinical~     studies used clinical parameters to detect and compare the effectiveness of such medical~     interventions. In this study we will use non invasive computerized method of wheeze and~     crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in~     RSV Bronchiolitis.~   "
243925|NCT00361439|"~     People with allergies frequently complain of a loss or reduction in the sense of smell.~      In this study, the investigators propose to perform a randomized, double blind, placebo~     controlled parallel study of subjects with nasal allergies and decreased smell to determine~     the effect of a treatment for allergies on the sense of smell.~   "
243926|NCT00361426|"~     Continuous measurement of breathing patterns, heart rate, restlessness and cough in sleep~     using EarlySense ES 16 device. Predicting worsening in COPD patients' condition using the~     above parameters.~   "
243955|NCT00361049|"~     RATIONALE: Donor mesenchymal stem cell infusion may be an effective treatment for acute or~     chronic graft-versus-host disease caused by a donor stem cell transplant.~      PURPOSE: This phase I trial is studying the side effects and best dose of donor mesenchymal~     stem cells in treating patients with acute or chronic graft-versus-host disease after~     undergoing a donor stem cell transplant.~   "
243956|NCT00361036|"~     A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in~     the treatment of uterine fibroids by embolization with respect to clinical & imaging outcome~     with comparison of primary safety endpoints to Embosphere.~   "
243927|NCT00361413|"~     Alefacept (AMEVIVE®) is an immunosuppressive dimeric fusion protein. It was shown to~     interfere with lymphocyte activation by specifically binding to the lymphocyte antigen, CD2,~     and inhibiting LFA-3/CD2 interaction. Alefacept was evaluated in two randomized,~     double-blind, placebo-controlled studies in adults with chronic (>1 year) plaque psoriasis~     and a minimum body surface area involvement of 10% who were candidates for or had previously~     received systemic therapy or phototherapy. The response to alefacept was significantly better~     in both studies. In both studies, onset of response to alefacept treatment (defined as at~     least 50% reduction of baseline Psoriasis Area and Severity Index (PASI)) began 60 days after~     the start of therapy.~      Graft versus host disease (GVHD) is the most ominous side effect of allogeneic stem cell~     transplantation (SCT). It causes severe inflammatory process, which is usually located to the~     skin, gut and liver. Treatment of GVHD consists of various immuno-suppressive and~     immuno-modulating drugs, including steroids, cyclosporine, tacrolimus, methotrexate etc.~     These drugs unfortunately can also cause severe immunologic failure that makes the patient~     prone to infection and malignancy, and other medication-specific side effects. In spite of~     this effect on the immune system, not all of the patients achieve control of GVHD, which~     usually rapidly leads to death. Despite the use of innovative immunosuppressive modalities,~     the prognosis of steroid resistant GVHD is usually poor.~      It was shown that CD2 depletion of allografts could prevent GVHD. Alefacept was never~     systemically tried in GVHD but A phase II study of BTI-322, a rat monoclonal IgG2b directed~     against the CD2 antigen in steroid-refractory acute GVHD showed a total response rate of 55%.~     We showed that alefacept might have a beneficial effect in controlling steroid resistant~     aGVHD and chronic GVHD. It was also shown to dramatically change the nature of transfusion~     associated GVHD.~   "
243928|NCT00361400|"~     This study is an examination of high risk young women, 15-24 years of age, who initiate~     first time use of vaginal ring, oral contraceptives, contraceptive path, or Depo-provera.~   "
243929|NCT00361387|"~     Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis~     and its treatment can greatly affect your quality of life. Many patients suffer from fatigue~     (feeling tired), lack of focus and concentration, in ability to organize their daily~     activities, and memory loss. These commonly reported symptoms often get in the way of~     everyday life.~   "
243930|NCT00361374|"~     This study examines the difference in the effectiveness of two natural compounds,~     eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major~     depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is~     believed that a deficiency in these omega-3 fatty acids may lead to the development of major~     depression.~   "
243931|NCT00361361|"~     The purpose of this study is to determine whether 308nm Excimer Laser therapy are effective~     in the color correction of white striae.~   "
243932|NCT00361348|"~     The purpose of this study is to determine if Paliferim interacts with Heparin.~   "
243933|NCT00361335|"~     The purpose of this study is to assess the clinical effectiveness and safety of golimumab~     intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with~     MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX~     treatment. In addition, the safety of subcutaneous (SC) golimumab injections following~     transition from IV golimumab infusions will also be evaluated.~   "
243934|NCT00361322|"~     The concept behind our study was to combine an effect of antibiotic and anti-inflammatory~     agents for a more efficient acne therapy directed at the factors involved in the~     pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin~     phosphate and salicylic acid in a non-irritating carrier.~   "
243935|NCT00361309|"~     The main purpose of this study is to begin to collect information and try to learn whether~     SU011248 works in treating patients with advanced liver cancer. Laboratory studies have shown~     that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from~     growing any further.~   "
243936|NCT00361296|"~     RATIONALE: Vaccines made from cancer cells may help the body build an effective immune~     response to kill abnormal cells.~      PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients~     with myelodysplastic syndromes (MDS).~   "
243937|NCT00361283|"~     The purpose of the study is to test whether atorvastatin (also known as Lipitor) has~     anti-inflammatory effects in people with no known heart disease or high cholesterol. We also~     are investigating whether or not genetic differences between people plays a role in the drug~     response.~   "
243938|NCT00361270|"~     The purpose of this study is to assess the effectiveness of hypnosis in the treatment of~     chronic low back pain.~   "
243939|NCT00361257|"~     The purpose of this study is to determine the effectiveness of minocycline, an antibiotic, in~     lessening the decreased mental function sometimes caused by anti-HIV drugs.~   "
243940|NCT00361244|"~     The purpose of this study is to determine the safety of SU011248 and the highest dose of this~     drug that can be given safely in combination with the chemotherapy drugs irinotecan and~     cetuximab. Laboratory studies have shown that SU011248 may block the growth of blood vessels~     in tumors, which may prevent tumors from growing any further. Other studies have demonstrated~     the possibility that SU011248 may enhance the anti-tumor activity of other chemotherapy drugs~     such as irinotecan and cetuximab.~   "
243941|NCT00361231|"~     The purposes of this study are to test the safety of bevacizumab when given in combination~     with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has~     on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or~     stop cell growth in tumors by decreasing the blood supply to the tumors.~   "
243942|NCT00361218|"~     The purpose of this study is to find out if two tests are useful in predicting whether~     someone with depression will get better when he or she is treated with an FDA approved~     antidepressant medication (either citalopram or escitalopram).~   "
243943|NCT00361205|"~     Patients with Parkinson's Disease (PD) depend on medication for relief of motor symptoms, and~     for this reason are often assumed to medicate very carefully. Overall, medication adherence~     is very good, but a subset of 15 to 20% of cases take less than 80% of the total prescribed~     dose. However, irregular timing of drug ingestion is almost universal, perhaps contributed by~     fluctuating symptoms and drug regimen complexity. Pulsatile dopaminergic stimulation in the~     basal ganglia is implicated in the development and manifestation of motor complications of~     advancing PD. Irregular medication intake is likely to contribute to peaks and troughs in~     serum and brain drug levels. In other diseases, patient adherence to prescribed medication~     improves through simplifying drug regimens, providing additional education, counselling and~     behavioural approaches and providing reminder packaging. We tested the effect on the timing~     of medicine ingestion of an educational approach, in which patients were given detailed~     additional information about the continuous dopaminergic theory.~   "
243944|NCT00361192|"~     Introduction~      Temporal arteritis (TA) is the most common primary vasculitis in the adult population. TA is~     a systemic multi-organ disease but primarily involves the cranial arteries, especially the~     temporal artery. The signs and symptoms of the disease are variable and therefore the~     differential diagnosis is often difficult. The annual incidence of the disease in the~     population above the age of 50 in Jerusalem is about 10 per 100,000.~      Diagnosis is based on the clinical findings and confirmed by biopsy of the temporal artery,~     positive for histologic findings of arteritis. Though the biopsy procedure is minor and can~     be accomplished under local anesthesia, it is not without morbidity. Along with minor pain,~     more serious complications - facial nerve injury, ptosis, stroke, and local necrosis of skin~     - have been reported.~      A negative biopsy does not completely rule out the diagnosis of TA because of the segmental~     nature of the inflammation. Even if one removes an appropriate length of artery (usually 1-2~     cm) the possibility exists that an involved segment may not have been included and the biopsy~     will be reported as normal.~      It has recently been reported that color Doppler ultrasonography can be used to diagnose TA.~     Arterial inflammation causing peri-vascular edema appearing as a dark halo and segmental~     stenosis of the temporal artery are characteristic ultrasound findings suggestive of TA. If~     there is no dark halo sign, a diagnosis of TA cannot be supported and temporal artery biopsy~     can be avoided in most of these patients. The presence of the dark halo sign has a positive~     predictive value of only 50%.~      As noted above the disease is characterized by segmental involvement of the artery and to~     avoid a false negative biopsy, excision of up to 3cm of the artery has been recommended,~     thereby increasing the morbidity, and leading patients to refuse the procedure. Use of~     ultrasound-guided biopsy of the artery may dramatically raise the sensitivity and specificity~     of the biopsy and reduce the requirement for excising long segments of artery.~      Objective~      The objective of this study is to examine the use of ultrasound-guided biopsy of the temporal~     artery in the diagnosis of TA. Ultrasound-guided biopsy will be compared to the standard~     random biopsy generally in use. Appropriate statistical methods will be employed.~      Methods~      The Vascular Laboratory in Shaare Zedek Medical Center performs approximately 200 Doppler~     ultrasound studies of the temporal artery each year at the request of community-based~     physicians. Some of these patients are then also referred for biopsy of the temporal artery~     at various surgical facilities in the city. In collaboration with the referring physician,~     the patients will be offered a combined diagnostic Doppler ultrasound and guided biopsy on~     the basis of clinical guidelines and according to the ultrasound findings as described below.~      Patients suffering from signs and symptoms consistent with TA and who have not undergone~     previous temporal artery biopsy will be included.~      Patients suffering from isolated polymyalgia rheumatica will be excluded. Patients who are~     already undergoing steroid treatment will be excluded. Patients with an ultrasound study that~     is positive for the dark halo sign will be divided into two groups on a random basis after~     obtaining informed consent.~      One group will undergo ultrasound-guided biopsy, while the other will undergo biopsy as is~     the standard practice in our institution - a 1-2cm length of temporal artery will be excised~     from the preauricular area.~      If the ultrasound is negative, no biopsy will be done in the setting of this study.~      It is expected that about 50 patients will be accrued during the 6-month study period.~     Differences in outcome will be analyzed using Fishers exact test.~      Approval from the Helsinki committee of Shaare Zedek Medical Center has been requested.~   "
243945|NCT00361179|"~     Chronic hepatitis C may relapse in simple chronic hepatitis C patients who initially obtained~     sustained virologic responses. Although the HCV SVR could be maintained in around 90%, the~     remaining 10% of these patients may develop hepatitis C relapse during follow-up. Therefore,~     it is important to follow up the long-term of these patients with dual chronic hepatitis B~     and C.~      From another aspect, for the treatment of chronic hepatitis B, the virologic and serologic~     responses may also not be durable. Alternatively, previous studies suggested that the~     therapeutic efficacy might not be seen in the study period, and incremental response might~     occur during long-term follow-up. Therefore it is also important to clarify the long-term~     outcome of treatment in this dually infected population.~      Evaluation of the long term effects of treatment with peginterferon alfa-2a plus ribavirin~     for patients with chronic hepatitis C/ hepatitis B co-Infection and chronic hepatitis C in~     the original study ML17862 is important. This present protocol is thus to assess whether the~     HCV SVR is sustained and to assess the durability of the HBV virologic and serologic~     responses or any incremental response during a 5-year follow-up period, including six months~     after end of the therapy in the original study and an additional 4 and half years in this~     project (5 years overall follow-up after the end of treatment). Specifically, we wish to~     assess the (1) sustained virologic response (SVR) of HCV in both populations, (2) incidence~     of HBsAg loss and HBsAg seroconversion (HBsAg loss and appearance of anti-HBs) in dually~     infected population, (3) ALT normalization or flare off-treatment during both populations,~     (4) reductions of HCV RNA from the original baseline levels in the two patient populations,~     and (5) reduction of serum HBV DNA off-treatment in the dually infected population.~   "
243946|NCT00361166|"~     The primary purpose of this study is to determine whether a combination of ACP-103 (the study~     medication) with either haloperidol or risperidone will show antipsychotic efficacy and that~     it is safe and well tolerated. Further purposes of this study are to determine whether~     ACP-103, in combination with either haloperidol or risperidone, will enhance their~     antipsychotic effectiveness, demonstrate effectiveness against the negative symptoms, improve~     motoric tolerability, and is safe and well tolerated.~      This is a seven-week study (one week screening and six weeks of study medication) where a~     total of 400 patients who meet entrance criteria will randomly be assigned to receive one of~     five groups of study treatments of either low dose haloperidol plus ACP-103, low dose~     haloperidol plus placebo (a substance similar to a sugar pill), low dose risperidone plus~     ACP-103, low dose risperidone plus placebo, or high dose risperidone plus placebo. The study~     will begin with with a three to seven day drug-free period followed by six weeks of a stable~     daily dosage of study medication. Study subjects will be treated as hospital in-patients~     during screening and for the first 14 days of the study. Study subjects will be closely~     monitored throughout the study.~   "
243947|NCT00361153|"~     This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control~     in patients with type 2 diabetes by making their own insulin work more efficiently.~   "
243948|NCT00361140|"~     Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6,~     -5, -4, and -3. Daily treatment doses will be adjusted to achieve target area under the~     plasma concentration time curve (AUC). Day 0 is the day of hematopoietic progenitor cell~     reinfusion. Supportive care will be based on institutional guidelines. Blood samples will be~     collected for dose modification based on the AUC levels. Dose escalation will proceed to~     determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit~     of higher doses of busulfan.~   "
243949|NCT00361127|"~     In patients with chronic heart failure ACE-inhibitor treatment improves lung diffusion and~     prevents pulmonary edema after fluid overload. In the western country, 3 population types of~     ACE genotypes exist (DD, ID, II). It is unknown whether the ACE genotype influences the~     response to fluid overload in ACE-inhibitor treated chronic heart failure patients.~   "
243950|NCT00361114|"~     Intermittent Preventive Treatment of malaria in infants is a promising strategy to reduce~     incidence of clinical malaria in children under the age of 1 year. It is likely to be~     implemented as a malaria control strategy in Tanzania using sulfadoxine/pyremethamine SP. SP~     is failing as a first line treatment for clinical episodes of malaria and government policy~     is driving a change to use Artemesin Combination Therapy (ACT). The main ongoing Kilimanjaro~     IPTi study is looking at alternatives to SP for use in IPTi. Currently, as there is no~     evidence for the use of other drugs for IPT, SP will be continued for IPT in pregnancy and in~     infants. This study proposes to measure the efficacy of SP and chlorproguanil/dapsone (CD),~     in symptomatic 6- 59 month old children using standard methodology. These are both study~     drugs in the main IPTi study. This will help us to see how the efficacies of SP and CD in~     sick children relate to the efficacies for treating asymptomatic children with IPTi. In~     addition this proposal aims to test the efficacy of SP given to 2-10 month old asymptomatic~     infants (the target group for IPTi). Evidence suggests that asymptomatic malaria infections~     with low parasitaemia have a higher cure rate than symptomatic infections with high~     parasitaemia even when markers of resistance are highly prevalent. This second study aims to~     quantify this difference and will produce evidence to help policy makers know when drugs used~     for IPTi should be changed. Both studies will be open label and run concurrently in Hale,~     Korogwe district near to the main Kilimanjaro IPTi site in Tanzania.~   "
243951|NCT00361101|"~     The purpose of this study is to determine the safety and activity of AMD11070 in HIV-infected~     patients carrying X4-tropic virus.~   "
243952|NCT00361088|"~     In Phase I, patients will receive a combination of PS-341 (Velcade) and R115777 (Zarnestra)~     to determine the dose limiting toxicity (DLT). Once DLT is determined, patients in Phase II~     will be receive the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment~     will continue if there is evidence of continued response for 8 cycles. Patients will receive~     follow up to include normal laboratory evaluations at least every 3 months and a skeletal~     survey will be performed at least every 6 months.~   "
243953|NCT00361075|"~     The postmenopausal state is associated with an increase risk for heart disease. Much of this~     increase in risk may be due to the loss of estrogen (the main female hormone) and the effect~     of this loss on lipids (blood fats). This loss of estrogen is often treated by estrogen~     replacement therapy. Estrogen replacement therapy seems to have a beneficial effect on lipid~     levels. The purpose of this research study is to understand 1) how menopause affects lipids~     and 2) how hormone replacement therapy effects the lipid metabolism of postmenopausal women.~   "
243954|NCT00361062|"~     SSRIs are the first line of therapy for anxiety and depressive disorders and for many other~     clinical diagnoses. One of the most disturbing side effects that is observed is a tendency~     towards aggressiveness among patients receiving medications from this group, mainly during~     the first month of therapy. Aggressive behavior tends to occur in some individuals but not in~     others. In some sub-groups of people, personality and character traits might make a person~     more prone to aggressive behavior.~      In this study the investigators try to estimate the tendency towards aggressive behavior in~     patients prescribed to a medication from the SSRI group. By using a comparative computer~     simulation they hope to be able to detect delicate changes and to maybe get some clues of the~     personalities prone to aggressive behavior in the future.~   "
243957|NCT00361023|"~     Angiotensin type-1 receptor (AT1R) blockers (ARBs) have been recognized recently as~     regulators of glucose and lipid metabolism in adipocytes and adipose tissue.Moreover~     telmisartan and irbesartan have been recognized recently as regulators of glucose metabolism.~     For ARB losartan, the results were controversial. To confirm its effect on glucose~     metabolism, we designed and performed a prospective, randomized and controlled study in~     subjects with type 2 diabetes and nephropathy.~   "
243958|NCT00361010|"~     Childhood absence epilepsy (CAE) is a form of generalized epilepsy syndrome. Clinically these~     seizures are manifest with a sudden, brief (3-15 second) loss of awareness followed by a~     quick recovery to baseline. Keppra (levetiracetam) is approved by the U.S. Food and Drug~     Administration (FDA) to treat partial seizures in adults. It is currently being studied in~     children with partial seizures. Absence seizures can be difficult to detect clinically,~     therefore the response to therapy will be determined both by clinical observation and by 24~     hour EEG recordings. The researchers hope that with this information they will learn how well~     it works for the treatment of childhood absence epilepsy and at what dose. This is an~     open-label, dose-ranging pilot study of levetiracetam in subjects with newly diagnosed~     childhood absence epilepsy. Approximately 20 patients will be needed to study effectiveness~     and dose requirements. Subjects must not be on any antiepileptic medication at the time of~     entry into the study. Male and female subjects from the ages of 4 to 10 years of age may~     participate.~   "
243959|NCT00360997|"~     The purpose of this study is to find which of three doses of mobilisation and tactile~     stimulation therapy, when given in addition to conventional UK physical therapy, has the most~     beneficial effect on enhancing motor recovery of the upper limb early after stroke.~   "
243960|NCT00360984|"~     Severe hypoglycaemia leading to collapse without warning is one of the most-feared~     complications for those with Type 1 diabetes. The aim of this study is to determine whether~     detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous~     insulin regime or continuous insulin regime can restore hypoglycaemia awareness in Type 1~     diabetes. Following a 6-day continuous subcutaneous monitor glucose profile, participants~     will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current~     insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia;~     or continuous subcutaneous insulin infusion. Symptomatic experience and severity of~     hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals,~     response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. It~     is envisaged that successful prevention of hypoglycaemia by one or more interventions may~     reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.~   "
243961|NCT00360971|"~     RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth~     sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It~     is not yet known whether palifermin is more effective than a placebo in lessening mucositis~     in patients receiving radiation therapy and chemotherapy for head and neck cancer.~      PURPOSE: This randomized phase III trial is studying palifermin to see how well it works~     compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy~     and chemotherapy for locally advanced head and neck cancer.~   "
243962|NCT00360958|"~     Patients with severe congestive heart failure show increased fluid body content which is~     often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients~     have frequent access to the emergency room and hospital for hemodynamic instability.~     Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The~     purpose of this study is to determine whether periodic ultrafiltration sessions maintain~     patients in stable clinical condition and reduce hospitalisations as well as access to~     emergency heart failure treatment.~   "
243963|NCT00360945|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide~     works in treating young patients with malignant glioma.~   "
243964|NCT00360932|"~     5 year, open-label study to evaluate safety of SCULPTRA on the signs of lipoatrophy of the~     face in at least 100 evaluable subjects with human immunodeficiency virus.~   "
243965|NCT00360919|"~     This purpose of this study is to perform a pilot investigation to determine if opioid~     peptides such as casomorphin can be detected in human plasma after cheese ingestion.~   "
243966|NCT00360906|"~     Based on previous clinical studies indicating beneficial treatment effects of omega-3 fatty~     acids in multiple sclerosis, and the increasing evidence of anti-inflammatory effects of~     omega-3 fatty acids, this study aims to evaluate treatment effects of concentrated omega-3~     fatty acids (Triomar™) in MS, both as monotherapy and in combination with standard~     immunomodulatory therapy defined as interferon-beta 1a (Rebif™).~   "
243967|NCT00360893|"~     OBJECTIVE— The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful~     impact of glycemic control on the early manifestations of microvascular complications.~      Contemporary prospective data on the evolution of macrovascular and late micro vascular~     complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and~     Complications (EDIC) study is a multicenter, longitudinal, observational study designed to~     use the well-characterized DCCT cohort of 1,400 patients to determine the long-term effects~     of prior separation of glycemic levels on micro- and macrovascular outcomes. EDIC is in its~     13th year of followup. The study is expecting to last until 2016.~      RESEARCH DESIGN AND METHODS— Using a standardized annual history and physical examination, 28~     EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual~     evaluation also includes resting electro c a rdiogram, Doppler ultrasound measurements of~     ankle/arm blood pressure, and screening for nephropathy. At regular intervals, a timed 4-h~     urine is collected, lipid pro files are obtained, and stereoscopic fundus photographs are~     taken. In addition, dual B-mode Doppler ultrasound scans of the common and internal carotid~     arteries will be perf o rmed at years 1 and 6 and at study end.~   "
244007|NCT00360334|"~     This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral~     antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic~     control, as measured by hemoglobin A1c, with minimum weight gain, in patients with~     uncontrolled type 2 diabetes on OADs.~   "
243968|NCT00360867|"~     This is an extension study to provide ongoing treatment with AMG 706 monotherapy for subjects~     with solid tumors who have completed the planned duration of AMG 706 treatment on a separate~     Amgen protocol and have been evaluated as having stable disease or better. Subjects who are~     no longer eligible to continue AMG 706 treatment on a separate Amgen protocol (for reasons~     other than AMG 706 intolerance), but who are receiving clinical benefit or have the potential~     to receive clinical benefit from AMG 706 per the investigator are also eligible to~     participate in this trial.~   "
243969|NCT00360854|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     erlotinib together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when~     given alone or together with radiation therapy in treating young patients with refractory or~     relapsed malignant brain tumors or newly diagnosed brain stem glioma.~   "
243970|NCT00360841|"~     The purpose of this study is to evaluate auricular acupuncture as an antiemetic treatment~     compared with sham acupuncture and with no acupuncture in patients receiving moderately-high~     to highly emetogenic chemotherapy. Acupuncture constitutes a nonpharmacological intervention~     for chemotherapy-induced nausea/vomiting (CINV). Chinese medicine holds that stimulating~     select points both on the body and the ear, that lie along meridians or life channels, can~     relieve diseases.~   "
243971|NCT00360828|"~     Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at~     each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine.~      At each cycle, patient exams and interviews as well as lab results were to help the research~     team to determine the symptomatic side effects of the treatment. Recorded past toxicities~     were to be compared with current side effects.~   "
243972|NCT00360815|"~     Background. Long-term microvascular and neurologic complications cause major morbidity and~     mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether~     intensive treatment with the goal of maintaining blood glucose concentrations close to the~     normal range could decrease the frequency and severity of these complications.~      Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the~     primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort)~     were randomly assigned to intensive therapy administered either with an external insulin pump~     or by three or more daily insulin injections and guided by frequent blood glucose monitoring~     or to conventional therapy with one or two daily insulin injections. The patients were~     followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other~     complications were assessed regularly.~   "
243973|NCT00360802|"~     The primary purpose of this study is to determine the effectiveness of two psychological~     techniques in chronic low back pain patients treated in hospital pain clinics. The techniques~     are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a~     multiple site project in which patients come from 16 different pain clinics throughout Spain.~     The control group is formed by patients under usual medical treatment at pain clinics. The~     two intervention groups also receive usual medical treatment at pain clinics plus one~     psychological therapy treatment. The sample size is 330 subjects.~   "
243974|NCT00360789|"~     The purpose of this study is to test the hypothesis that adding functional strength training~     to UK conventional therapy improves muscle function and walking than either UK conventional~     therapy alone or increased intensity of UK conventional therapy.~   "
243975|NCT00360776|"~     This phase II trial is studying how well tipifarnib works in treating patients with anemia or~     neutropenia and large granular lymphocyte leukemia. Tipifarnib may stop the growth of~     leukemia by blocking blood flow to the cancer cells and by blocking some of the enzymes~     needed for cancer cell growth.~   "
243976|NCT00360763|"~     The autoantibodies against AT1 receptor (ATR-AA), behaving like an agonist were detected in~     patients with hypertension. ATR-AA which can blocked by ARB may play a role in the~     pathogenesis of hypertension. The present study is to explore whether AT1 receptor blocker~     has superior anti-hypertensive effect in patients with positive ATR-AA hypertension. Patients~     with 2 grade hypertension were recruited and ATR-AA was assayed by ELISA. A study was carried~     out and the efficacy of anti-hypertension was compared between candesartan cilexetil and ACE~     inhibitor imidapril.~   "
243977|NCT00360750|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, etoposide, and~     cytarabine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving chemotherapy with or without radiation therapy after surgery may kill any~     tumor cells that remain after surgery. Sometimes, after surgery, the tumor does not need more~     treatment until it progresses. In this case, observation may be sufficient.~      PURPOSE: This clinical trial is studying how well chemotherapy with or without radiation~     therapy or observation works in treating young patients with advanced retinoblastoma who have~     undergone surgery to remove the eye.~   "
243978|NCT00360737|"~     The primary purpose of the study is to evaluate the safety of the 7 Botulinum Antitoxin~     Serotypes derived from horses using various laboratory measurements, clinical examinations~     and adverse events. In addition, following intravenous (injected into the vein)~     administration assessing how much 7 Botulinum Antitoxin remains in the body.~   "
243979|NCT00360724|"~     The investigators are studying a new antidepressant medicine, duloxetine, for the treatment~     of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by~     the FDA for the treatment of major depression. The investigators are testing whether this~     medicine is also effective for adults with chronic depression (dysthymic disorder or~     dysthymia).~      Chronic depression, lasting two or more years, often causes significant suffering and~     impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during~     which half of the participants will take the new medication and half will take a placebo (an~     inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin,~     during which all subjects can be treated with an FDA-approved antidepressant medication.~      Eligible subjects may also receive MRI scans, to help the investigators understand how~     antidepressants work in treating depression.~   "
244057|NCT00359632|"~     To understand and characterize the effects of linezolid on the optic nerve by observing and~     following patients who have been treated with linezolid for six weeks or longer for the~     development of signs or symptoms of visual disturbance or eye disorders.~   "
243980|NCT00360711|"~     This study will examine the experience of moral value conflicts among genetic counselors.~     Previous research has shown that value conflicts do exist among genetic counselors, but~     little is known about the nature or consequences of these conflicts. This is a sub-study of~     the Manifestations and Consequences of Moral Distress Among Genetic Service Providers: An~     Exploratory Study, which includes genetic counselors, nurses and medical geneticists.~      Genetic counselors are recruited for this value-conflict sub-study from among those~     participating in the Moral Distress study. Participants are interviewed in-depth by telephone~     about their experiences of moral value conflicts with clients. The interviews cover the~     following: situations in which the counselor has disagreed with a client's decision or views~     on a moral level; the counselor's thought processes during and after a session in which~     conflicts arise; the counselor's feelings and emotions associated with sessions involving a~     moral value conflict; the counselor's current and previous work settings; the counselor's~     view of his or her role and responsibility in a client's decision; challenging a client's~     values or decision; and preparation for value conflicts.~   "
243981|NCT00360698|"~     To evaluate the efficacy of a single injection of glulisine before the main meal added to~     insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs~     in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.~   "
243982|NCT00360685|"~     A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day~     +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and~     discontinued by day +180. In addition patients will be randomized to methotrexate (MTX) or~     mycophenolate mofetil (MMF) and again, in the absence of GVHD, a tapering schedule will begin~     on day +240 and be completed on day +360. Doses will be adjusted to maintain blood levels.~   "
243983|NCT00360672|"~     The goal of this clinical research study is to find out if Revlimid can help to control the~     disease in patients with relapsed/refractory acute myelogenous leukemia (AML) or high-risk~     myelodysplastic syndrome (MDS) with abnormalities in chromosome number 5. The safety of this~     treatment will also be studied.~   "
243984|NCT00360659|"~     We wanted to test the hypothesis that treatment with continuous positive airway pressure~     reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a~     fall in blood pressure patients with obstructive sleep apnea.~   "
243985|NCT00360646|"~     The purpose of this study is to establish retrospectively a nationwide registry of patients~     who have suffered drug-induced liver injury (DILI), and to collect, immortalize and store~     serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for~     subsequent mechanistic investigations into the basis of severe idiosyncratic DILI. The~     primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of~     individuals who have experienced severe DILI caused by four specific drugs, and the relevant~     clinical data concerning the episode of DILI; and, (b) to create a bank of biological~     specimens obtained from these individuals. These biological specimens will be DNA, plasma,~     and immortalized lymphocytes. Immortalized lymphocytes will provide unlimited amounts of~     genomic DNA for study as well as living immune cells for phenotyping studies. A secondary~     goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD database so that~     they may be recontacted in the future. It is expected that this will facilitate additional~     studies exploring the mechanisms of DILI.~   "
243986|NCT00360633|"~     Parkinson's Disease (PD) is often thought of as affecting movement only. In fact, most~     patients also experience psychiatric and cognitive symptoms, sometimes from the disease~     itself, and sometimes as a side-effect of PD medications. The goals of this study are to~     evaluate the causes, effects, and clinical correlates of psychiatric and cognitive symptoms~     in PD.~   "
243987|NCT00360607|"~     Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic~     bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such~     as Enterobacteriaceae and Bacteroides fragilis, which are the commonest organisms known to~     cause such infections. Combinations of a third-generation cephalosporin, an aminoglycoside~     and metronidazole are often used to treat such infections in surgical settings. An~     alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor~     combination. Magnex (cefoperazone- sulbactam) is one such combination, which has been shown~     to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the~     management of intra-abdominal infections. The combination of ceftazidime, amikacin and~     metronidazole has been chosen as a comparator regimen because of its broad coverage of~     Gram-negative and anaerobic organisms found in such conditions.~   "
243988|NCT00360594|"~     Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of~     alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol~     detoxification instead of waiting until detoxification has been completed effects the course~     of detoxification, adverse events during detoxification, drop out rate during the~     rehabilitative treatment phase, or overall efficacy of acamprosate for those with alcohol~     dependence who plan to receive at least two months of rehabilitative pharmacotherapy with~     acamprosate.~   "
243989|NCT00360581|"~     The purpose of this study is to develop strategies to maintain smoking abstinence initiated~     in pregnancy and prevent relapse in the postpartum period.~   "
243990|NCT00360568|"~     Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.~   "
243991|NCT00360555|"~     This trial is designed to assess the safety and efficacy of flibanserin in the treatment of~     premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard~     diagnostic criteria.~      Efficacy for flibanserin will be assessed vs. a parallel placebo group.~   "
243992|NCT00360529|"~     This trial is designed to assess the safety and efficacy of flibanserin in the treatment of~     premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard~     diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.~   "
243993|NCT00360516|"~     If eating a Paleolithic diet helps improve these diseases, this would be the first step in~     both improving people's health as they get older as well as contributing to future national~     dietary guidelines for Americans.~   "
244028|NCT00360035|"~     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow~     unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis~     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process~     of cell death that is often inhibited in cancer cells.~   "
243994|NCT00360503|"~     People with cystic fibrosis (CF) often develop chronic pulmonary infections which are caused~     by a variety of organisms, the most predominant being Pseudomonas aeruginosa. Antibiotics are~     important in managing CF lung infections. Antibiotic use in CF was altered about ten years~     ago with the approval of inhaled tobramycin, an aminoglycoside which is effective in treating~     P. aeruginosa. A decade later, CF clinicians are increasingly concerned about the likelihood~     of induction of aminoglycoside-resistance with prolonged use of inhaled tobramycin to treat~     chronic P. aeruginosa airway infections. The goal of this study is to examine the current~     microbiology and susceptibility of organisms from CF sputum, correlate it with antibiotic~     use, and compare it with previous data.~   "
243995|NCT00360490|"~     The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine~     system is effective in decreasing menstrual blood loss.~   "
243996|NCT00360477|"~     The patient will be asked to participate in a research project designed to determine the best~     way to prevent bleeding and promote patient comfort after having kidney stones removed. Two~     standard methods for ending the surgery are being compared to a newer method. In one standard~     method, the patient will have a tube draining urine from the kidney after the procedure. This~     tube may also prevent bleeding from the kidney. In another standard method the patient will~     have a tube left internally that drains urine from the kidney to the bladder and a stitch~     will be used to close the incision and deeper tissues in the back. In the third potential~     option, a tube would be left internally to drain urine from the kidney to the patient's~     bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is~     a FDA approved agent specifically formulated to stop bleeding during surgical procedures.~   "
243997|NCT00360464|"~     To evaluate the clinical efficacy and safety in patients with Acute Bronchitis or Secondary~     Infection of Chronic Respiratory Diseases receiving a dose of 2 g of azithromycin in the SR~     formulation.~   "
243998|NCT00360451|"~     This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based~     cognitive behavioral depression prevention program for young adolescents.~   "
243999|NCT00360438|"~     Primary~      1. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with~     leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS)~      Secondary~        1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first~          rasburicase treatment) through 48 hours after the last per-protocol planned~          administration of rasburicase treatment;~        2. To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma.~        3. To evaluate incidence, duration, and type of immune responses (IgG, IgE, and~          neutralizing antibody) to rasburicase.~   "
244000|NCT00360425|"~     This study will define the effects of ferumoxytol on electrocardiogram (ECG) data as well as~     evaluate pharmacokinetics~   "
244001|NCT00360412|"~     Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who~     meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase,~     lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56).~     All patients will receive active study drug. During the Titration Phase, patients will~     receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During~     the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug~     at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be~     withdrawn from the study.~      Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In~     addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60).~      A home diary will be completed in which patients rate themselves as either:~        1. OFF~        2. ON without dyskinesia~        3. ON with non-troublesome dyskinesias~        4. ON with troublesome dyskinesias~        5. Asleep~      These entries will be completed every half hour during the waking day and will be completed~     for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days~     prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20,~     32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global~     Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be~     performed.~   "
244002|NCT00360399|"~     This study will compare different treatments for depression in order to identify which~     factors predict effectiveness, and will include a companion study which investigates~     combining treatments and long term effectiveness.~   "
244003|NCT00360386|"~     -  To compare the Kinetics of inhibition of platelet aggregation (aggregometry) and~          platelet activation (flow cytometry) with different loading doses of clopidogrel~        -  To evaluate the effect on various parameters of inflammation and necrosis and the safety~          of these loading doses~   "
244004|NCT00360373|"~     The purpose of this research study is to find out what effects (good and bad) gastric bypass~     has on metabolism, including pancreatic insulin secretion. In addition, we will compare the~     effects of gastric bypass on the metabolism of adults and adolescents to try to determine~     whether there are greater metabolic and health advantages of performing gastric bypass~     earlier in life versus waiting until adulthood.~   "
244005|NCT00360360|"~     We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy~     (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first~     line treatment of patients with carcinoma of unknown primary site. There is limited~     experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site~     but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis~     pathways and/or the EGFR pathway are effective strategies in at least a proportion.~   "
244006|NCT00360347|"~     This study will investigate the efficacy, safety and pharmacokinetics of Mircera in adult~     anemic patients with multiple myeloma. In the first stage of the study, patients will be~     randomized to receive subcutaneous injections of Mircera once every 3 weeks, at doses of 2.0,~     3.5 or 5.0 micrograms/kg. Following the administration of 2 doses, an evaluation of~     hemoglobin increase will be made at week 6. In the second stage, further groups of patients~     will receive additional doses of Mircera,at doses of 1.0, 6.5 or 8.0 micrograms/kg, depending~     on efficacy, safety and pharmacokinetic considerations.The anticipated time on treatment is~     3-12 months, and the target sample size is <100 individuals.~   "
244819|NCT00349453|"~     Systematical (retro- and prospective) investigation of the long-term safety (toxicity~     assessment according to CTCAE v3.0) and efficacy of deferiprone either given alone or in~     combination with desferrioxamine~   "
244008|NCT00360321|"~     International surveys about pathological gambling estimate that there are about 1 to 3 per~     cent of gamblers who develop a pathological behavior about gamble.In France, pathological~     gambling is not a priority of public health, in contrast with other addictive disorders, like~     alcoholism or nicotine addiction. The aim of our study is to describe accurately for the~     first time in France, a sample of “at risk” and pathological French gamblers. We want to~     collect socio-demographical and clinical data from this subjects (story of the addictive~     behaviour, co morbidities, and more specifically, detailed study of pathological gamblers’~     personality), in order to compare our data with those of international~     literature.Secondarily, we want to test the feasibility of this kind of detailed evaluations~     for another study planned for 2007-2008 and which purpose will be to compare pathological~     gamblers’ personality characteristics according to the kind of game that they mainly~     practice.The participation at the study will be proposed to every patient consulting in the~     “service d’addictologie du CHU de Nantes”. The study consists in a single evaluation (about 8~     hours) with standardized tools used all other the world.~   "
244009|NCT00360308|"~     Randomised, double-blind, double dummy, parallel group design. Following the screening period~     patients will be randomised at the baseline visit, in a 1:1:1 manner, to one of three~     treatment arms; 4 mg E2007, 200 mg entacapone (with each dose of levodopa) or placebo. The~     first 4 weeks of the double blind phase will be used to titrate patients on the E2007 arm~     from 2 mg up to the maintenance dose of 4 mg. Patients randomised to entacapone or placebo~     will have dummy up titrations to maintain the blind. Following this titration phase, patients~     will remain on the maintenance dose for a further 14 weeks.~      Patients will have visits at 2, 4, 6, 10, 14 and 18 weeks after baseline. A follow up visit~     will be performed at Week 22.~      A home diary will be completed in which patients rate themselves as either:~        1. OFF~        2. ON without dyskinesias~        3. ON with non-troublesome dyskinesias~        4. ON with troublesome dyskinesias~        5. Asleep~      These entries will be completed every 30 minutes during the waking day and will be completed~     for three consecutive days immediately prior to visits at Baseline, Weeks 6, 10, 18 and 22.~      At Baseline (Day 0), week 10 and 18 the Unified Parkinson's Disease Rating Scale (UPDRS -~     Parts I, II , III and IV) will be performed.~      At the end of the treatment period (Week 18), patients will undergo final efficacy and safety~     assessments and will stop taking the study medication they were receiving. They will be seen~     4 weeks later for a follow up visit.~   "
244010|NCT00360295|"~     To evaluate the clinical efficacy and safety in patients with mild or moderate~     community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.~   "
244011|NCT00360282|"~     The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers~     motion sickness in migraine sufferers.~   "
244012|NCT00360269|"~     The aim of the study is to determine if atomoxetine treatment combined with motivational~     enhancement therapy is effective in reducing marijuana use in adult individuals with~     attention-deficit hyperactivity disorder and marijuana dependence.~   "
244013|NCT00360256|"~     The objective of this pilot study is to determine the genetic polymorphism rate of CYP450 2D6~     and 2C19 metabolic enzymes in patients with significant adverse effects from antidepressants,~     compared to a population of patients who had no significant adverse effects from~     antidepressants metabolized by CYP2D6 and 2C19.~      The hypothesis for the proposed research is that the rate of 2D6 and 2C19 alleles that are~     associated with poor metabolizer status in the treatment-intolerant population will far~     exceed the rate found in patient population who takes antidepressants without adverse~     effects.~   "
244014|NCT00360243|"~     This trial is designed to assess the safety and efficacy of flibanserin in the treatment of~     premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard~     diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.~   "
244015|NCT00360230|"~     This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines~     administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian~     children. The Protocol Posting has been updated in order to comply with the FDA Amendment~     Act, Sep 2007.~   "
244016|NCT00360217|"~     This study will explore the ability of an algae (ocean plant) omega-3 fat supplement (DHA) to~     reduce triglyceride levels in patients currently being treated with statin therapy (Zocor or~     simvastatin, Lipitor or atorvastatin, Pravachol or pravastatin, Crestor or rosuvastatin,~     etc.) for coronary artery disease(CAD)or risk equivalents (any of the following: heart~     attack, post angioplasty or stent, post coronary bypass surgery, angina, vascular disease,~     stroke or diabetes).~      The rationale for the study is based around the finding that patients with CAD have an~     approximately 20 % reduction in the risk of sudden death when treated with fish oil (DHA is~     one of the ingredients in fish oil). In studies of statin-based therapies, it has been~     observed that statins reduce the risk of coronary events 20-45%. There has not yet been~     research trials exploring the combination of the two ingredients (i.e., DHA plus statin) in~     patient treatment either to reduce recurrent cardiac events or to address another reported~     finding of fish oils to lower triglyceride levels (triglyceride is a form of blood fat).~     This research project will be a pilot project to assess the safety and effectiveness of DHA~     add-on therapy in patients currently being treated with statins for CAD.~      The study hypothesis is to test the effectiveness of DHA as compared to placebo to lower~     triglyceride levels in the blood. This is a double-blinded randomized clinical trial.~   "
244029|NCT00360022|"~     The purpose of this study is to determine if the program that has been made to ease the~     transition of care for adolescent patients with IBD from pediatric gastroenterology to adult~     gastroenterology is effective to reduce the risk of disease flare during this period. Patient~     satisfaction with this program will also be assessed.~   "
244030|NCT00360009|"~     The purpose of this trial is to study the mood and cognitive effects of deep brain~     stimulation in Parkinson's disease.~   "
244031|NCT00359996|"~     The purpose of this study is to determine whether a quality improvement intervention~     including rapid quality improvement, a chronic care model, and best practices improves~     diabetes care in community health centers and whether more intensive interventions enhance~     care further.~   "
244329|NCT00355992|"~     The purpose of the study is to evaluate the utility of Ischemia Modified Albumin (IMA) for~     risk stratification in patients presenting with chest discomfort and possible ischemic heart~     disease, and to evaluate the diagnostic and prognostic implication for IMA for major adverse~     cardiac events.~   "
244017|NCT00360204|"~     Because adherence to postnatal care guidelines across the United States (U.S.) is poor,~     newborns and mothers often are placed at undue risk for adverse medical and social outcomes.~     This study aims to evaluate an alternative model of care and improve healthcare delivery to~     and reduce health disparities for well newborns and mothers after hospital discharge by~     using single postnatal home nurse visits. The principal investigator has previously shown a~     reduction in poor outcomes for infants who receive a home visit after discharge when studied~     retrospectively. The proposed research will build on the previous study and prospectively~     evaluate the impact of a single home nursing visit on morbidities and health disparities for~     newborns and mothers in a randomized, controlled trial involving 1154 mother/infant~     breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk~     period of infancy and motherhood, where medical and social problems can be recognized,~     anticipated, and/or treated, and can bridge the gap between hospital care and primary care.~     The investigators' program, The Nurses for Infants Through Teaching and Assessment after the~     NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation~     compared with guidelines-adherent outpatient clinic care.~   "
244018|NCT00360191|"~     The purpose of this study is to determine if buspirone combined with motivational enhancement~     therapy is effective in reducing marijuana use in marijuana-dependent adults.~   "
244019|NCT00360178|"~     Recruiting in Germany only:~      This study will evaluate the safety and efficacy of valsartan plus HCTZ in fixed dose~     combination in hypertensive patients not responding to treatment with the free combination of~     Candesartan plus HCTZ. In an optional extension patients with uncontrolled BP at the end of~     the core study can be treated with valsartan plus HCTZ in fixed dose combination plus~     amlodipine 5 mg for additional 4 weeks.~   "
244020|NCT00360152|"~     Sentinel lymph node biopsy (SLNB) has recently emerged as a less invasive alternative to~     axillary lymph node dissection (ALND) in the treatment of breast cancer. However, SLNB has a~     number of limitations, and we believe that alternative strategies for staging of the axilla~     should be explored. The hypothesis of this proposal is that the combination of preoperative~     high-resolution axillary ultrasound (AUS), fine needle aspiration biopsy (FNAB), and~     molecular analysis using real-time reverse transcription-polymerase chain reaction (RT-PCR)~     represents a viable, minimally invasive alternative to SLNB. We propose a prospective cohort~     study to rigorously assess the diagnostic accuracy of molecular analysis of AUS-FNAB~     specimens. The primary endpoint of this study is to determine the feasibility of AUS-FNAB and~     real-time RT-PCR to predict the pathologic status of the axilla in a proof-of-principle~     study. In the short term, validation of this innovative strategy is likely to reduce the~     number of sentinel node procedures. In the long term, we believe that AUS-FNAB may ultimately~     replace SLNB.~   "
244021|NCT00360139|"~     Lipoatrophy is a condition that affects certain individuals, most commonly those who are~     infected with the HIV virus. Lipoatrophy however can also affect individuals who suffer from~     recurrent systemic infections, those who have a weakened immune system, or certain patients~     who suffer from cancer or receive chemotherapeutics. In contrast, lipoatrophy can sometimes~     be present in individuals who are perfectly healthy but have genetically predisposing factors~     that can contribute to facial emaciation or lipoatrophy.~      The function of injectable fillers for the treatment of dermal contour deformities is to~     smooth dermal depressions formed by the loss of volume. These often elastic contour fillers~     (also known as soft tissue augmentation devices) can correct hollowness around the eyes, add~     fullness to thin lips, balance a disproportionate face or correct topographical anomalies.~      This study aims to:~        -  Objectively measure the improvement of contour-deformities after Sculptra™ injection~          from baseline to study closure by utilizing the Primos™ photographic/topographical~          measuring system.~        -  Evaluate the efficacy, longevity and duration of volume-correction in subjects which are~          both HIV positive and HIV negative.~        -  Assess the safety of Scupltra™ dermal filler when used to correct volume deformities~          caused by lipoatrophy in subjects that are HIV negative.~   "
244022|NCT00360126|"~     The precursor study (SCA101469) was an open-label, prospective multicentre study in adult~     subjects diagnosed with bipolar disorder consisting of 36 weeks treatment with lamotrigine.~     The current study is to provide 12 months post study access to open-label lamotrigine for~     participants of the SCA101469 study.~   "
244023|NCT00360100|"~     Assess tolerability of different dosing formulations (adult versus pediatric).~   "
244024|NCT00360087|"~     This study will assess the safety and efficacy of bosentan therapy (in a study known as~     ASSET) for patients who have high blood pressure in the lungs associated with sickle cell~     disease. That form of hypertension places people at risk for complications, including~     shortness of breath, pain, pneumonia, and death. Previous studies have shown that bosentan~     can be helpful in reducing pulmonary hypertension.~      Patients ages 16 and older who have completed the 16-week treatment in the ASSET 1 or ASSET 2~     study and who are not pregnant or breastfeeding may be eligible for this study. The research~     will be conducted in about 25 hospitals in the United States and Europe. Up to 30~     participants will be enrolled. The screening visit will involve a physical examination, blood~     sample of about 3 teaspoons for laboratory tests, and a pregnancy test. Patients' doctors~     will give them bosentan tablets (62.5 mg each), to take one in the morning and one in the~     evening. After 1 month, patients will be told whether the dose should be increased to 125 mg~     tablets to take twice a day. Two weeks after the increase in dose, a blood test will be done~     to analyze the drug's effects on the liver. After the start of treatment, patients will~     return for visits every 6 months, when there will be a 6-minute walking test to measure~     exercise capacity and evaluate shortness of breath. There will be follow-up for patients up~     to the end of the study and for 28 days after the last dose of bosentan is taken, to collect~     information about side effects.~      Some patients on bosentan have had changes in liver function and red blood cell count. Side~     effects commonly reported are headache, flushed appearance, inflammation of the throat and~     nasal passages, and gastrointestinal symptoms. If patients have sudden worsening in breathing~     in the first few weeks after taking bosentan, they should immediately tell their doctors,~     because it may be necessary to change the treatment.~   "
244025|NCT00360074|"~     The purpose of this study is to determine whether a body weight adjusted dose of thyroxin is~     superior to treatment guided by laboratory results of thyroxin hormones in patients with~     central hypothyroidism. Moreover beneficial effects of triiodthyronine supplementation are~     investigated.~   "
244026|NCT00360061|"~     The effectiveness of cognitive behavioural therapy (CBT) for adolescents with type 1 diabetes~     will be tested. This structured, time-limited, problem-orientated therapy will be used to~     impact on psychosocial factors influencing diabetic control, with the patient and therapist~     working together on specific goals to develop adaptive strategies.~   "
244027|NCT00360048|"~     The aim of this study is to determine if oxytocin administration is able to blunt LPS induced~     increase of cytokines (TNF-α) and if there is a change in the endocrine response after~     lipopolysaccharide administration in humans.~   "
244032|NCT00359983|"~     This study is evaluating antibody persistence at 1, 3 & 5 years post-fourth dose (i.e., at 2,~     4 & 6 years of age, respectively) in subjects vaccinated in a previous study.~      This protocol posting deals with objectives & outcome measures of the extension phase at~     years 1, 3 and 5. The objectives & outcome measures of the first four doses are presented in~     a separate protocol posting (NCT00129129).~      This protocol posting has been amended in order to comply with the FDA Amendment Act of~     September 26, 2007.~   "
244033|NCT00359970|"~     In a previous study azithromycin proved as efficacious as levofloxacin in the treatment of~     travelers' diarrhea in Mexico. Because the addition of loperamide to some antibiotics (e.g.,~     trimethoprim-sulfamethoxazole and ofloxacin) has proven more efficacious than antibiotic~     alone in the treatment of travelers' diarrhea, we decided to study the addition of loperamide~     to azithromycin.~      US adults with acute diarrhea in Guadalajara Mexico were randomized to receive azithromycin~     in two different doses or loperamide plus azithromycin.~      The duration of diarrhea was shorter (11 hours) in the combination-treated group compared to~     the antibiotic-treated groups (34 hours). The percentage of subjects continuing to pass 6 or~     more unformed stools in the first 24 hours was less (1.7%) in the combination-treated group~     than in the antibiotic-treated groups (20%).~      We feel loperamide should routinely be added to an antibiotic to optimize treatment of~     travelers' diarrhea.~   "
244034|NCT00359957|"~     The purpose of this trial is to examine whether adding greater physical activity to standard~     family-based behavioral pediatric obesity treatment decreases the amount of visceral fat~     among treated overweight children.~   "
244035|NCT00359944|"~     The purpose of this study is to investigate efficacy and safety of different doses of AC-3933~     in patients with mild to moderate Alzheimer's Disease.~   "
244036|NCT00359931|"~     This study will use magnetic resonance imaging (MRI) to compare brain function in three~     groups of people: hearing-impaired people with tinnitus; hearing-impaired people without~     tinnitus; and people with normal hearing and without tinnitus. Also known as ringing in the~     ears, tinnitus is the false sensation of sounds.~      Adults between 30 and 65 years of age who meet the following criteria may be eligible for~     this study:~        -  Mild to moderate hearing loss who have experienced tinnitus daily for at least 1 year~        -  Mild to moderate hearing loss who have never or rarely experienced tinnitus~        -  Normal hearing who have never or rarely experienced tinnitus~      Candidates are screened with a medical history and questionnaires.~      Participants have a detailed hearing test to measure hearing and the nature of tinnitus. In a~     second visit, subjects have a brief physical examination, followed by MRI scanning. MRI uses~     a magnetic field and radio waves to produce images of body tissues and organs. For this~     procedure, the subject lies on a table that can slide in and out of the scanner (a narrow~     cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the~     scanning process. The subject may be asked to lie still for up to 8 minutes at a time. During~     the MRI, the subject performs computer-based tasks that involve listening to sounds. Another~     hearing test is done after the MRI.~   "
244037|NCT00359918|"~     Prehospital initiated facilitation of primary percutaneous coronary intervention by~     fibrinolysis might be helpful in re-opening the infarct related artery prior to percutaneous~     coronary intervention.~      This studies tests the hypothesis that prehospital initiated facilitated PCI is superior to~     primary percutaneous coronary intervention with respect to infarct size.~   "
244038|NCT00359905|"~     A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and~     tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe~     and effective (the first phase of the study lasts approximately 18 weeks) and then is used~     for another 9 months to determine its long-term safety.~   "
244039|NCT00359892|"~     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow~     unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis~     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process~     of cell death that is often inhibited in cancer cells.~      This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in~     2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with~     relapsed or refractory Hodgkin's Lymphoma. Infusions may be administered on an out-patient~     basis. No investigational or commercial agents or therapies other than those described in the~     protocol may be administered with the intent to treat the patient's malignancy. Supportive~     care measures including those directed at controlling symptoms resulting from Hodgkin's~     Lymphoma (blood products, growth factor, etc.) are allowed.~   "
244040|NCT00359879|"~     This trial is designed to compare the effects of twice-daily (before lunch and before dinner)~     exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before~     dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2~     diabetes.~   "
244041|NCT00359866|"~     Indications for post-hysterectomy radiation therapy (RT) have been well established by~     clinical data. Adjuvant RT has demonstrated local control and survival benefit. In patients~     with nodal disease, adjuvant chemotherapy concurrent with radiation has further improved the~     clinical outcome. The acute hematological and gastrointestinal toxicity of concurrent~     chemo-radiotherapy can be quite high, sometimes preventing patients from completed their full~     treatment course, potentially compromising the therapeutic benefit of treatment. Intensity~     modulated radiation therapy (IMRT) is an advanced method of delivering external beam~     radiation that may minimize the volume of normal tissue irradiated to high dose and thus~     decrease the risk of normal tissue toxicity. Helical tomotherapy is a novel treatment device~     with sophisticated imaging and treatment delivery features that are optimally suited for~     IMRT. There are retrospective clinical data supporting the use of non-tomotherapy delivered~     IMRT to treat patients with gynecologic cancers. The proposed study will prospectively test~     whether helical tomotherapy is a feasible method for delivering IMRT in post-hysterectomy~     cervical cancer patients receiving adjuvant RT. Here, the question of feasibility is simply~     one of verifying that target volumes are reliably covered by 'sculpted' IMRT high-dose~     regions. Although this is not a treatment effectiveness study, we will also follow the~     clinical outcome of these patients, including toxicity, local control and survival, in~     anticipation that this information will be valuable if the treatment modality is judged~     feasible and will be used for further treatments of this patient population.~   "
244042|NCT00359853|"~     Advanced liver disease and low ascitic fluid protein concentration have been identified as~     risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment~     and hyponatremia increase mortality rate of this infection. Aims: To investigate if oral~     administration of norfloxacin prevents the first episode of SBP, hepatorenal syndrome and~     improves survival in cirrhotic patients with ascites and low protein concentration in ascitic~     fluid (<15 g/L) and at least one of the following inclusion criteria: functional renal~     failure (serum creatinine ≥ 1,2 mg/dl or BUN ≥ 25 mg/dl), hyponatremia (serum sodium ≤ 130~     mEq/L) or advanced liver disease (Child ≥ 9 points with serum bilirubin ≥ 3 mg/dl). Methods:~     Prospective, multicenter, randomized, double-blind placebo controlled trial comparing oral~     norfloxacin (400 mg/d; n=35) with placebo (n=35).~   "
244043|NCT00359840|"~     To assess the clinical effective dose of KRN321 administered with once triweekly schedule.~   "
244044|NCT00359814|"~     The purpose of this study is to improve or save renal function by optimizing the~     immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of~     Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will~     minimize the risk of acute rejection episodes.~   "
244045|NCT00359801|"~     The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of~     Exubera in routine clinical practice.~   "
244046|NCT00359788|"~     The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with~     tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler~     (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic~     Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.~   "
244047|NCT00359775|"~     Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training~     (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12~     years of age and their parents. The participants in this study at Children's Hospital of~     Wisconsin are dealing with one of three chronic health conditions (Rheumatologic Conditions,~     Epilepsy,Spina Bifida, and Asthma).~      Research Questions/Study Aims~      The research questions addressed in the full study are:~        1. What is the impact of CST on child depression, QOL, health motivation, attitude toward~          illness, and self-management efficacy?~        2. What is the impact of CST on parent depression, perception of child's quality of life,~          perception of impact of CHC on family, and family conflict?~   "
244048|NCT00359762|"~     This study assesses the effects of twice-daily subcutaneous injection exenatide versus~     treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell~     function.~   "
244049|NCT00359736|"~     Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis~     (IPF) patients function better. This study will test whether sildenafil improves the ability~     to exercise in patients with pulmonary fibrosis of unknown cause.~   "
244050|NCT00359723|"~     The purpose of this trial is to determine if methylphenidate (MPD), a drug marketed in the~     U.S. to treat hyperactivity and narcolepsy, added to levodopa, will increase the beneficial~     effects of levodopa without bothersome side effects in people with Parkinson's disease (PD).~   "
244051|NCT00359710|"~     This study will collect the opinions, understandings and personal health care experiences of~     multiracial persons of African and European ancestry. Understanding multiracial patients'~     beliefs and experiences about their race, ethnicity, ancestral origin and the genetic~     components of diseases can provide important data for developing ways to communicate how~     human genetic variation is related to self-identified race and ethnicity. The study will:~        -  Investigate multiracial individuals' beliefs about biological and genetic differences~          based on race and ethnicity;~        -  Collect stories of identity, ancestry and clinical experiences of multiracial~          individuals with one parent of African ancestry and one parent of European ancestry;~        -  Investigate multiracial patients' experiences regarding family health history and~          communication of genetic risk of disease.~      Persons 21 years of age or older in the Atlanta, Georgia, or Washington, D.C., metropolitan~     areas who are from a multiracial background and have used health care services in the last 2~     years may be eligible for this study. Participants are interviewed one-on-one for about 2~     hours to gather information about their background, family ancestry, self-identity, race and~     ethnicity, health care interactions and genetics and health. Each participant completes a~     short questionnaire before and after the interview.~   "
244052|NCT00359697|"~     The overall purpose of this study is to compare the effects of mannitol and hypertonic saline~     on patients with increased intracranial pressure. The hypothesis being tested is that~     hypertonic saline is more effective in controlling increased intracranial pressure than~     mannitol.~   "
244053|NCT00359684|"~     Cystinosis is an inherited disease resulting in poor growth and kidney failure. There is no~     known cure for cystinosis, although kidney transplantation may help the renal failure and~     prolong survival. Both the kidney damage and growth failure are thought to be due to the~     accumulation of the amino acid cystine within the cells of the body. The cystine storage~     later damages other organs besides the kidneys, including the thyroid gland, pancreas, eyes,~     and muscle.~      The drug cysteamine (Cystagon) is an oral medication given to patients with cystinosis prior~     to kidney transplantation. The drug works by reducing the level of cystine in the white blood~     cells and muscle tissue. The drug may also decrease levels of cystine in the kidneys and~     other tissues.~      This study has several goals:~        1. <TAB>Long-term surveillance of cysteamine (Cystagon) treated patients.~        2. <TAB>Detection of new non-kidney complications of cystinosis.~        3. <TAB>Maintenance of a patient population for genetic testing (mutational analysis) of~          the cystinosis gene.<TAB>~   "
244054|NCT00359671|"~     A study to evaluate safety and tolerability of MK6592 in combination with an anti-cancer drug~     in adult patients with advanced solid tumors.~   "
244055|NCT00359658|"~     The purpose of this study is first to improve or save renal function and second to decrease~     cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and~     reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an~     effective immunosuppressive agent, will minimize the risk of acute rejection episodes.~   "
244056|NCT00359645|"~     Randomized multicenter trial to assess the impact of a screening program for heavy alcohol~     drinkers and smokers treated in alcohol addiction clinics on upper aerodigestive tract cancer~     mortality.~   "
244058|NCT00359619|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the~     uterus or womb). This infection may go away by itself, but if it does not go away (this is~     called persistent infection), it can lead in women over a long period of time to cancer of~     the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic~     types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also~     evaluating novel HPV vaccines formulations. This study will evaluate the long-term~     immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects~     who received the novel vaccine or the control vaccine administered in the primary study.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
244059|NCT00359606|"~     This phase I trial studies the side effects and best dose of 5-fluoro-2-deoxycytidine when~     given together with tetrahydrouridine in treating patients with solid tumors that have spread~     to other places in the body and usually cannot be cured or controlled with treatment~     (advanced). Drugs used in chemotherapy, such as 5-fluoro-2-deoxycytidine and~     tetrahydrouridine, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~   "
244060|NCT00359593|"~     The aim of this project is to evaluate whether using an implementation intervention promotes~     use of best practices by rehabilitation professionals and leads to improvements in patient~     outcomes for individuals with stroke.~   "
244061|NCT00359580|"~     The purposes of this study are to identify the genes responsible for several inherited~     disorders commonly seen in the Amish and Mennonite populations and learn more about the~     natural history (medical problems that develop over time) of these disorders. In addition,~     researchers will establish a computer database containing Amish genealogies, derived largely~     from the community s extensive records of births, marriages, deaths, etc., that will help~     construct pedigrees (family trees) for genetic study.~      The Amish and Mennonite peoples have a high rate of intermarriage within their individual~     communities, with a resulting high incidence of inherited disorders. Many of these disorders,~     such as cartilage-hair hypoplasia, Ellis-van Creveld syndrome, and others, are rarely seen~     outside these communities. New research using state-of-the-art methodologies in genetics will~     add to current knowledge about the causes and symptoms of these disorders that will~     eventually aid in their diagnosis and medical management.~      Patients with inherited disorders that occur frequently in the Amish and Mennonite~     populations and their family members may be eligible for this study. Individuals from both~     within and outside these communities may enroll.~      Participants will be evaluated with a review of their medical records and their personal and~     family medical history and a brief physical examination. A small tissue sample will be~     collected for genetic studies. This will be either a blood sample (3 teaspoons from adults~     and 1 to 3 teaspoons from children, depending on their size) or a mouth swab (cells removed~     from inside the cheek by gentle brushing). Some participants may undergo additional~     procedures, such as diagnostic X-rays, brain scans, echocardiogram (heart ultrasound) or~     other studies.~      If genetic testing shows a gene change (mutation), the participant will be notified to that~     effect in writing and offered counseling in their home regarding the test results and their~     implications.~   "
244062|NCT00359567|"~     To compare palonosetron with granisetron hydrochloride as a control in the efficacy of~     intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as~     nausea and vomiting induced by highly emetogenic chemotherapy.~   "
244063|NCT00359554|"~     The objective of this study is to demonstrate that influenza vaccination of nursing home~     workers is an effective intervention for reducing mortality of elderly people.~   "
244064|NCT00359541|"~     This study will look at how voriconazole, a drug used to treat or protect against fungal~     infections, affects the body. Adverse effects associated with voriconazole include skin~     problems and temporary changes in vision, mental status and liver function. There is some~     evidence that these side effects may be more intense when there are high levels of the drug~     in the blood. The amount of voriconazole in the body is determined by how much of the drug~     the patient receives and by the patient's ability to inactivate and excrete it, which may be~     determined in part by genes. This study will examine: 1) side effects patients develop from~     voriconazole; 2) whether the side effects experienced are related to the concentration of~     drug in the body; and 3) the role of genes in determining how quickly the body inactivates~     and excretes the drug.~      Patients 12 and older who are participating in studies in the National Institute of Allergy~     and Infectious Diseases (NIAID), the National Cancer Institute (NCI) or the National Heart,~     Lung, and Blood Institute (NHLBI) and have been treated with voriconazole for 15 days or less~     may be eligible for this study.~      Participation involves the following:~        -  Identification and recording of adverse effects patients experience due to voriconazole~          treatment~        -  Collection of basic information about the patient's medical history and treatment~        -  Blood draws once a week during the patient's hospitalization~        -  Collection of routine laboratory test results ordered by the patient's doctor~        -  Blood draw to identify genes responsible for voriconazole inactivation~        -  Weekly monitoring for the possibility of voriconazole adverse effects~        -  Blood draw to measure blood levels of voriconazole when the drug is stopped, if it is~          stopped because of an adverse effect~        -  Evaluations at outpatient visits, including a blood draw to measure voriconazole blood~          levels~      Participation in the study ends 7 days after voriconazole treatment is stopped because it is~     no longer needed.~   "
244065|NCT00359515|"~     This study will investigate the genetic basis of oculocerebrorenal syndrome of Lowe (OCRL)-a~     rare X-linked disorder (carried by females and passed to males). Patients with OCRL have~     abnormal development of the eye lens, developmental delay, muscle weakness and kidney~     dysfunction.~      The study will examine DNA and cell samples obtained and archived from patients with OCRL~     enrolled in a previous protocol (HG008A) between 1996 and 1999. It will identify mutations in~     the OCRL1 gene responsible for OCRL in affected males and try to correlate them with specific~     biochemical or cellular activities (e.g., enzyme activity, protein stability, cellular~     localization and trafficking). When test results are available, the information will be~     communicated to the patients, their parents (if the patient is a minor) and their physicians,~     and families will receive genetic counseling.~   "
244066|NCT00359489|"~     Methods study to evaluate use of cardiac ultrasound to assess heart valve abnormality in~     people.~   "
244067|NCT00359476|"~     The purpose of this study is to learn if vinflunine can shrink or slow the growth of cancer~     in patients with advanced or metastatic stomach cancer who have progressed on a prior~     treatment with a fluoropyrimidine or taxane-containing chemotherapy regimen. The safety of~     this treatment will also be studied.~   "
244068|NCT00359463|"~     The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down~     in the body by healthy subjects versus subjects with mild, moderate or severe liver problems.~     The study is also being done to 1) check on how well the study drug is tolerated by healthy~     subjects versus those with liver problems and 2) to check if liver impairment affects how the~     study drug binds to protein in the blood.~   "
244128|NCT00358683|"~     The primary aim of this study is allow the patients suffering from Crohn's disease , who both~     completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from~     the treatment, to receive treatment with certolizumab pegol until the drug is available for~     the Crohn's disease indication in Greece.~   "
244330|NCT00355979|"~     To evaluate and compare the effectiveness of intragastric balloon and Sibutramine (Reductil®)~     in the treating of non-morbid obese in a randomized controlled manner~   "
244069|NCT00359450|"~     BMS-275183 given orally twice weekly to patients pretreated for locally advanced or~     metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the~     patients enrolled:~        -  Cohort I: Patients previously treated with one taxane containing regimen.~        -  Cohort II: Patients previously treated with a platinum based but non-taxane containing~          regimen.~        -  Cohort III: Patients previously treated with both a chemotherapy regimen and one~          EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound.~      Patients in cohorts I and II should have not been treated with a prior EGFR-TKI compound.~     Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound~     is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR~     inhibitor.~   "
244070|NCT00359437|"~     Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the~     recurrence of ascites.~      Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over~     a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites.~      The one-year double blind placebo controlled period is extended up to 2 years in a long term~     safety study (PASCCAL-2).~   "
244071|NCT00359424|"~     The purpose of this study is to compare two different treatment approaches to recanalization~     started within 3 hours of symptom onset—combined intravenous (IV) and endovascular therapy~     and standard intravenous (IV) rt-PA alone.~   "
244072|NCT00359411|"~     This study will study the effects of the gene on the X chromosome that is associated with~     X-linked lymphoproliferative disease (XLPD)-an inherited disease affecting the immune~     system-on the function of the immune system. XLPD has been linked to an abnormality in a~     specific region of the X chromosome (one of 23 chromosome pairs that contain the genes that~     determine a person's hereditary makeup). The disease may develop after infection with the~     Epstein-Barr virus (EBV). EBV affects more than 95 percent of people in the United States. It~     usually does not cause any symptoms in children. In adolescents and adults, however, EBV can~     cause infectious mononucleosis and sometimes lymphoproliferative disease, such as XLPD. In~     these diseases lymph tissues, such as lymph nodes, may become enlarged and immune function~     (infection-fighting ability) impaired. This study will compare DNA from patients with XLPD~     with that of their unaffected relatives, of patients with other lymphoproliferative diseases~     and of normal controls.~      Patients of any age with XLPD, their unaffected relatives 18 years of age and older, and~     patients with other lymphoproliferative diseases may participate in this study.~      Blood samples will be collected from all participants to study the effects of the gene on the~     X chromosome that appears to be abnormal in XLPD on the function of the immune system. In a~     6-week period, no more than 100 milliliters (about 7 tablespoons) of blood will be drawn from~     adults and no more than 1 ml (1/6 teaspoon) of blood per pound of body weight from children.~     Blood from patients with XLPD and their relatives will also be tested for HLA type (similar~     to blood type testing) and the ability of HLA-matched cells from patients and relatives to~     interact will be examined.~   "
244073|NCT00359398|"~     Excessive bleeding is common after cardiac surgery. This may result in patients receiving a~     blood transfusion or suffering the life-threatening complication of cardiac tamponade.~     Tamponade is when excessive bleeding compresses the heart and prevents it from pumping~     properly. A major reason for the bleeding is the damage done to platelets by the~     cardiopulmonary bypass (CPB) machine. Often patients receive platelets and plasma from blood~     donors to try to reduce the bleeding post-operatively. The investigators plan to take~     platelets and plasma from patients before they are damaged. They would then return these~     'undamaged' sequestered platelets to the patients after the bypass machine is no longer~     needed. Therefore, the investigators' primary question is whether platelet sequestration~     would reduce the bleeding problems that occur following cardiac surgery. They will evaluate~     bleeding problems using thromboelastography, which provides a comprehensive assessment of~     both how blood clots form and their strength. If sequestration reduces bleeding problems~     following cardiac surgery then it may reduce the chance of patients receiving blood products~     from donors. Although donated blood is thoroughly tested, its use does expose patients to the~     risk of transfusion errors, blood borne infections and reactions. Avoiding its use would be~     very desirable.~   "
244074|NCT00359385|"~     We are investigating whether, after surgical cure of primary hyperparathyroidism, alendronate~     provides even greater beneficial skeletal effects than parathyroidectomy alone.~      Primary Hyperparathyroidism (PHPT) is a disorder that can be associated with bone loss. After~     successful surgery for PHPT bone density improves without any treatment. However, it is~     possible that bone density might improve to an even greater extent if Fosamax is used after~     the surgical cure. Fosamax is approved by the FDA for the prevention and treatment of~     osteoporosis, and the goal of this project is to determine whether after successful surgical~     cure of PHPT, Fosamax is even better for the skeleton than just parathyroid surgery alone.~   "
244075|NCT00359372|"~     This study will explore which characteristics of patients with heart failure will likely~     predict improvement after cardiac resynchronization (CRT), implantation of a pacemaker to~     improve heart function. In spite of major medical advances, about 30% to 40% of patients with~     heart failure do not respond to CRT, and the reasons are not well understood. This study will~     involve magnetic resonance imaging (MRI), electrocardiogram (ECG), and echocardiography~     techniques to let researchers examine what may influence response to CRT.~      Patients ages 18 and older with a left ventricular disorder and who are not pregnant or~     breastfeeding may be eligible for this study. Initial evaluation will take 5 to 6 hours. A~     blood sample of about 2 tablespoons will be collected, and several procedures will be~     performed. MRI uses a strong magnetic field and radio waves to obtain images of body organs~     and tissues. For that procedure, patients will lie on a table that slides into the enclosed~     tunnel of the scanner and be asked to lie still. They will be in the scanner for 30 to 90~     minutes. As the scanner takes pictures, patients will hear knocking sounds, and they may be~     asked to hold their breath intermittently for 5 to 20 seconds. During part of the scan, a~     drug called gadolinium will be given intravenously (IV), to make the heart easier to see.~     Patients will be able to communicate with the MRI staff at all times during the scan. At any~     time, patients may ask to be moved out of the machine. Patients having metal in their body~     that interferes with the MRI scanner should not have this test. During the procedure, an ECG~     machine will monitor the heart, through wires connected to pads on the skin. Patients will~     have an echocardiogram, in which sound waves look at the heart. A small handheld probe will~     touch the chest and abdomen, and an IV tube may be inserted to inject a contrast drug to~     improve the quality of heart images. Patients will have a cardiopulmonary stress test~     (treadmill test) and a 6-minute walk test, both before pacemaker implantation and then 6~     months afterward. Also before and after pacemaker implantation, patients will complete the~     Minnesota Living with Heart Failure Questionnaire, regarding the impact of heart failure on~     patients' lives. The follow-up visit will take 3 to 4 hours.~   "
244076|NCT00359359|"~     The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH~     Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in~     patients who did not receive prior treatment for their lung cancer~   "
244077|NCT00359346|"~     This study will explore whether an antibody is influencing the autonomic nervous system, and~     if its removal will eliminate signs and symptoms of failure in that system. The autonomic~     nervous system is responsible for many automatic changes involved in everyday activities,~     such as standing up, digesting food, and exercising in the heat. Antibodies fight germs but~     sometimes cause health problems. Removal of the antibody is done through a procedure called a~     plasma exchange.~      Patients with primary chronic autonomic failure and a circulating antibody to what is called~     the neuronal nicotinic receptor may be eligible for this study. To be eligible, patients will~     have participated in an earlier study, protocol number 03-N-0004. Patients will undergo tests~     and procedures that include an electrocardiogram, and blood collection for hepatitis, HIV,~     and pregnancy. Blood will be tested for a complete blood count, clotting factors, and~     chemistries. There will also be tests for liver function, kidney function, cortisol, and~     thyroid. Participants will be tested for signs and symptoms of autonomic failure, and will be~     asked to complete questionnaires about various symptoms before the plasma exchange, 1 or 2~     weeks afterward, and then monthly or bimonthly for up to 1 year. Patients will undergo a~     series of other tests. In one test, a patient is upright and blows against a resistance~     (Valsalva maneuver). The quantitative sudomotor axon reflex test (QSART) uses iontophoresis,~     involving application of acetylcholine, a chemical messenger, and a small amount of~     electricity. QSART examines the regulation of sweating, a particular aspect of the autonomic~     nervous system. There will be a test using edrophonium, given intravenously (IV), to evaluate~     that drug's effects on the heart, skin, glands, gastrointestinal activity, bladder tone, and~     salivation. A glucagon test, also by IV, will show patients' ability to release the hormone~     adrenaline.~      The plasma exchange will be performed by use of an automated cell separator. Patients' blood~     will be removed continuously through a needle in the arm. Blood cells will be separated from~     the plasma by a spinning process and continuously returned to circulation through a needle in~     the patients' opposite arm. Blood cells that are returned will be mixed with albumin, a~     sterile replacement solution. A blood thinner, citrate, will be given, to prevent clotting of~     blood. This whole procedure will take about 2 hours. Patients will typically undergo five~     exchange procedures in about 10 days while they are inpatients at the NIH Clinical Center.~     The amount of plasma removed in a single session and the number of sessions will be set by~     the NIH Blood Bank. It is expected that patients' autonomic failure will improve after~     several days of starting the plasma exchange. Testing for symptoms of autonomic failure and~     autonomic function testing will occur about 1 month after the plasma exchange and monthly or~     bimonthly for up to 1 year. For each visit of testing, patients will be inpatients for about~     2 days. If autonomic failure recurs, patients may have a second plasma exchange, with the~     same follow-up tests, for about 1 year.~   "
244078|NCT00359333|"~     Study Design Type of Study This is an open-label, single arm, prospective, multiple-center~     phase II study~      Duration of the Study Period in One Subject Treatment duration is planned for six cycles,~     unless there is evidence of disease progression or unacceptable toxicity. Patients with~     continued response after six cycles could receive two additional cycles of therapy. In case~     complete response and in the absence of unacceptable toxicity, treatment will be continued~     for at least 2 further cycles to achieve the minimal of 6 total cycles.~      Study Objectives Primary Objective The primary objective is to determine the response rate of~     sequential gemcitabine and docetaxel combination in patients with locally advanced/metastatic~     soft tissue sarcoma or imatinib mesylate refractory GIST.~      Secondary Objectives The secondary objectives of this study are to determine the time to~     progression in patients treated with this regimen, the toxicity of this regimen in these~     patients, the overall survival and the quality of life.~      Molecular analysis of genetic aberration in soft tissue sarcoma The genetic aberrations of~     soft tissue sarcoma as reported in literature will be determined. The genetic aberration will~     be correlated to chemotherapy responses.~      c-kit and PDGFR gene mutations induced by imatinib mesylate and chemotherapy Those acquired~     gene mutation of c-kit and PGDFR induced by imatinib mesylate will be first determined. We~     will also examine further gene mutation of c-kit and PGDFR caused by combination~     chemotherapy.~   "
244079|NCT00359320|"~     The purpose of this trial is to determine whether a mucosa-to-mucosa technique of~     pancreaticojejunostomy will improve the pancreatic fistula rate.~   "
244080|NCT00359307|"~     The purpose of this study is to identify genes associated with certain risk factors for~     atherosclerosis (hardening of the arteries) and its consequences, such as development of~     coronary artery disease, heart attack, other blood vessel disease and stroke.~      People enrolled in the Framingham Heart Study in Framingham, Massachusetts, are eligible to~     participate in this study. They will undergo a medical history, including review of their~     medical records and a family history; evaluation of memory and mood; breathing test and~     electrocardiogram (EKG); blood and urine tests, including blood sample collection for DNA~     (genetic) testing; evaluation of gait (walking), balance and hand grip strength; and hearing~     test. They will also fill out questionnaires on their eating habits and general health.~      Any patients who may suffer a stroke during the study will be examined during their~     hospitalization and at 3, 6, 12, and 24 months after the stroke. This examination includes a~     neurological evaluation, assessment of ability to perform daily living tasks and, possibly,~     magnetic resonance imaging (MRI) of the brain, a test that uses a strong magnetic field and~     radio waves to produce pictures of the brain.~   "
244081|NCT00359294|"~     Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study.~     The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and~     recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days~     every 3 weeks (this is considered as 1 cycle) to subjects with advanced malignant solid~     tumors or lymphoma.~   "
244082|NCT00359281|"~     This phase II, open-label research study was conducted in 129 healthy volunteers. Each~     subject will be given one initial oral dose of one of 7 FDA-approved medications (probe~     drugs), followed by a 7 day period where subjects receive the study medication AEGR-733 at 10~     or 60 mg. On study day 8 subjects will receive the second oral dose of the same probe drug~     that was given on day 1 and a last dose of AEGR-733 (total of 7 doses).Subjects will return~     in 1 week for a final safety visit. Each FDA- approved probe drug will be given to ten (10)~     or fifteen (15) subjects.~      Safety, pharmacokinetic and pharmacodynamic assessments will be performed.~   "
244083|NCT00359268|"~     This study will try to identify new or known viruses responsible for diseases or conditions~     of unknown cause. Viruses are an important cause of illness. They have been identified as~     causes of several cancers, including certain liver cancers and cervical cancer. Several~     diseases, such as Kawasaki s disease, aplastic anemia, aphthous ulcers, and certain fevers of~     unknown origin in immune suppressed patients are thought possibly to be due to viruses, but~     their cause has not yet been determined. This study will use very sensitive molecular~     techniques to try to identify new or known viruses in patients with conditions of unknown~     causes. This study does not involve any treatment.~      Any patient with a condition or disease whose cause is unknown may be eligible for this~     study. A referral from a local physician is required for patients who wish to enroll in this~     study.~      Participants will have blood samples drawn up to four times during the study. The total~     amount of blood drawn in any 6-week period will not exceed 50 milliliters (about 3-1/2~     tablespoons) for adults and 5 ml (about 1/2 tablespoon) per kilogram (2.2 pounds) for~     children. In addition, body fluids, such as joint or spinal fluid, or tissue samples, such as~     biopsy specimens, obtained previously for medical purposes, may be obtained for testing.~      The patient s doctor will be informed of any positive findings from the samples.~     Identification of a virus does not necessarily mean that the virus is causing the patient s~     condition or disease. Additional tests from many patients with similar diseases or conditions~     are required before a virus can be definitively associated with a disease. Similarly, failure~     to find a virus does not necessarily mean that the patient is not infected with a virus that~     is causing the condition, as the tests used in this study are imperfect and will not detect~     certain forms of viruses that can cause disease.~   "
244084|NCT00359255|"~     This study would focus on a new method of adding extra arm exercise to the usual therapy~     delivered in the hospital. We propose to design an exercise program for the affected arm and~     hand that would be given to the client as homework and done in the client's hospital room.~     The program would be designed and monitored by a therapist that works in the hospital.~      We believe that this program will: 1) increase arm and hand recovery over usual care received~     in the hospital, 2) help people make the move from therapist run exercise to self management~     of exercise, and 3) promote family involvement in therapy.~   "
244085|NCT00359242|"~     Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even~     among very young children. Because the current evidence base regarding potentially effective~     early intervention components to prevent obesity is so incomplete, it is logical to initiate~     obesity prevention intervention research during infancy, focusing on the two major components~     of the infant lifestyle, sleeping and feeding.~   "
244086|NCT00359229|"~     Primary objective:~      1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in~     China~      Secondary objectives:~        1. To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in~          China.~        2. To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia~          in China~   "
244229|NCT00357370|"~     The purpose of this clinical research study is to learn if BMS-512148, added to insulin and~     one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can~     help reduce the blood sugar levels compared to insulin and one or two anti-diabetes~     medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2~     diabetes. The safety of this treatment will also be studied.~   "
244087|NCT00359216|"~     This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind~     study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with~     Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak~     Nasal Inspiratory Flow (PNIF), Embletta device home-monitored cardiopulmonary evaluations,~     and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age~     with symptomatic PAR (with or without SAR) will be selected and randomized at one study site.~     The anticipated duration of subject participation in the study is approximately 39 days.~     Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening~     period. Following the run-in period, subjects who meet the qualifications at the Baseline~     Visit will be treated with study medication for 4 weeks.~   "
244088|NCT00359203|"~     ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to~     assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated~     syncope.~   "
244089|NCT00359190|"~     This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream~     mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer~     patients for three dosing schedules of lapatinib.~   "
244090|NCT00359177|"~     The purpose of the study is to evaluate how subjects with mild or moderate liver problems~     process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.~   "
244091|NCT00359164|"~     To determine if Visudyne photodynamic therapy (low or very low fluence rate) combined with~     intravitreal injections of bevacizumab (Avastin) compared with bevacizumab alone will, with~     similar safety and efficacy, delay time to retreatment with bevacizumab after the initial~     treatment, in subjects with new wet AMD Hypothesis: PDT in combination with Avastin at either~     the low or very low fluence rate will delay time to retreatment and reduce the average number~     of treatments required, compared to Avastin alone, but will have a similar safety and~     efficacy profile.~   "
244092|NCT00359151|"~     This study will investigate the benefits of administering celecoxib (Celebrex), a selective~     cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing~     elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the~     management of post total knee replacement pain, and through the 6 weeks of physical therapy~     and rehabilitation.~   "
244093|NCT00359138|"~     This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single~     center study in subjects with positive histamine skin prick test and a positive~     RadioAllergoSorbent Test (RAST) (class > 2) to one of the tested standardized allergenic~     extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens.~     Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily,~     or placebo once daily for 8 days of treatment followed by 11 days of skin testing after~     discontinuation of the antihistamine treatment phase. The duration of the suppressive effects~     of desloratadine on cutaneous allergen-induced wheal and flare responses after~     discontinuation of a one-week treatment will be established.~   "
244094|NCT00359125|"~     Bipolar disorder is a chronic and recurrent illness which involves episodes of mania and~     depression. It is believed that disturbance of the stress hormone system (the~     hypothalamic-pituitary-adrenal or HPA axis) may cause thinking and memory problems and make~     the depressive symptoms worse in bipolar disorder. Early studies have shown that mifepristone~     may have antidepressant effects (may improve the symptoms of depression) and may also~     maintain or enhance cognition (memory and thinking functions).~      The purpose of this study is to determine the potential therapeutic efficacy (usefulness) of~     mifepristone in bipolar depression by assessing the effects of the medication on depressive~     symptoms and on cognition. This will be done by questionnaires and thinking tests.~      This study will also try to clarify the functional changes that accompany bipolar disorder by~     analyzing saliva samples (assessing the stress response by measuring the levels of 2 stress~     hormones: cortisol and DHEA).~   "
244095|NCT00359112|"~     This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and~     metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.~   "
244096|NCT00359099|"~     This is a retrospective chart review. We hypothesize that patients who have undergone~     congenital heart surgery, prior to screening of blood products have a significant risk of~     hepatitis C infection and all such patients would benefit from screening for hepatitis C.~   "
244097|NCT00359086|"~     In this study, MGCD0103, a new anticancer drug under investigation, is given three times~     weekly to patients with relapsed and refractory lymphoma.~   "
244098|NCT00359073|"~     People with asthma may have asthma worsening when they have an upper respiratory infection~     due to a virus or a common cold. Leukotrienes are increased in nasal secretions from children~     with Respiratory Syncytial Virus (RSV) and lung washings during times of acute lung~     inflammation. Experimental virus exposure in adults is also associated with increases in~     nasal leukotrienes.~      The degree to which leukotrienes play a role in asthma worsening is unknown.There is~     information linking leukotrienes to viral infections, allergic inflammation, and asthma~     exacerbation.This information supports the hypothesis that virus-induced leukotrienes~     contribute to the severity of respiratory infections and in susceptible individuals, lead to~     lower airway obstruction and exacerbations of asthma. We propose to use montelukast in an~     experimental viral challenge model to explore this hypothesis.~   "
244099|NCT00359060|"~     Purpose of the SHAPE study is to examine the effects of an 1-year exercise programme on~     endogenous hormone levels associated with breast cancer among sedentary postmenopausal women~     and whether a decrease in intra-abdominal fat is associated with a lowering of these hormone~     levels.~   "
244100|NCT00359047|"~     The aim of the ROCQ programme is to improve the use of evidence based osteoporosis diagnostic~     and treatment strategies for women 50 years and over who have suffered a fragility fracture.~     This objective will be achieved by concentrating on a realistic evaluation of the present~     diagnosis and treatment rate of osteoporosis following a fragility fracture and comparing it~     to an optimal situation (care gap) and proposing interventions that promote new approaches to~     treating osteoporosis by health professionals as well as providing targeted interventions for~     the patient. The efficacy of these interventions will be evaluated using a randomized control~     design.~   "
244331|NCT00355966|"~     Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at~     term, results in significant shortening of induction to delivery time in comparison to~     vaginal PGE2 gel induction.~   "
244101|NCT00359034|"~     We are interested in determining if we can measure the blood flow in the descending aorta~     (large blood vessel in the abdomen) of healthy fetuses and fetuses with growth restriction.~     An increasing number of adult diseases (e.g. heart and blood vessel disease) are recognized~     as potentially associated with fetal growth and development.~      Pulse wave velocity (PWV) is a measure of blood flow in blood vessels. This is routinely~     measured in adults, and has recently been studied in children. The purpose of our study is to~     see if we can develop a simple ultrasound method to measure the PWV in fetuses.~      The purpose of this study is to see if we can consistently measure the blood flow patterns in~     the fetal descending aorta (large blood vessel in the abdomen) of 20 healthy fetuses and 20~     growth restricted fetuses using standard ultrasound techniques.~   "
244102|NCT00359021|"~     The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200~     mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator~     selected optimized background in HIV-1 infected patients who have participated in a DUET~     trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week~     24 or later in these trials.~   "
244103|NCT00359008|"~     The primary objective of this study is to assess the ability of the PHP & HPHP to detect~     newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced~     age related Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD~   "
244104|NCT00358995|"~     A New Cognitive Behavioral Therapy to Target Distorted Appraisals Characteristic of Primary~     Obsessions in Obsessive Compulsive Disorder~   "
244105|NCT00358982|"~     MGCD0103 is an experimental drug that belongs to a class of drugs known as the histone~     deacetylase inhibitors, which may restore normal control in cancer cells by affecting the~     genes and proteins that are being made. Laboratory tests show that this new investigational~     anti-cancer drug can slow down the growth of human cancer cells in mice; two clinical~     research studies are currently being performed in humans with cancer and a similar study is~     being performed in patients with the same disease.~      The purpose of this study is to find out what effect the experimental drug MGCD0103 has on~     patients with relapsed and refractory Hodgkin's lymphoma.~   "
244106|NCT00358969|"~     This study is designed to investigate whether guanfacine (Tenex) is an effective treatment~     for borderline personality disorder (BPD), an illness often characterized by unstable mood~     and impulsive aggression. Guanfacine stimulates activity in the front portion of the brain, a~     region associated with attention and the control of behavior. We believe that guanfacine may~     improve symptoms of BPD by improving attention and aiding regulation of behavior.~   "
244107|NCT00358956|"~     This will be a Phase II, open label study to establish the effect of once-daily oral doses of~     ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid~     cancer in whom no standard therapeutic option is available.~   "
244108|NCT00358943|"~     The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational~     program that tracks the routine clinical outcomes for patients with Gaucher disease,~     irrespective of treatment status. No experimental intervention is involved; patients in the~     Registry undergo clinical assessments and receive care as determined by the patient's~     treating physician.~      The objectives of the Registry are:~        -  To enhance the understanding of the variability, progression, and natural history of~          Gaucher disease with the ultimate goal of better guiding and assessing therapeutic~          interventions;~        -  To provide the Gaucher medical community with recommendations for monitoring patients~          and to provide reports on patient outcomes to help optimize patient care; and~        -  To evaluate the long-term effectiveness of Cerezyme.~   "
244109|NCT00358930|"~     This is a Phase 2, multi-center, open label study of ARQ 501 in patients with locally~     advanced, recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).~   "
244110|NCT00358917|"~     The purpose of this study was to compare the safety, tolerability, and antiviral activity of~     once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet~     formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors~     (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects~     with detectable viral load while receiving their current antiretroviral therapy.~   "
244111|NCT00358904|"~     Subjects who have had the Weber osteotomy for Hill-Sachs lesions will have CT of Both~     shoulders. Amount of rotation in operative shoulder will be compared to contralateral. QOL~     will be assessed~   "
244112|NCT00358891|"~     Although previous studies showed that preterm infants resolving from neonatal respiratory~     disease are more likely to exhibit respiratory illness, developmental disorders, impaired~     growth and cognitive limitations compared with those without, the information concerning the~     longitudinal respiratory and neurodevelopmental outcome of recently survived preterm infants~     with CLD is limited.Therefore, the purpose of this study is threefold. First, VLBW infants~     with CLD, VLBW infants without CLD and full-term infants will be examined for respiratory~     health at 3-5 years old and will be assessed the relations of early respiratory and~     environmental variables with later respiratory outcome. Secondly, all infants will be~     examined for neurodevelopmental outcome, and will be assessed the relations of early~     neuromotor and environmental variables with later neurodevelopmental outcome. Thirdly, the~     VLBW infants will be assessed for the concurrent and consecutive longitudinal relationships~     between respiratory and neurodevelopmental measures.~   "
244113|NCT00358878|"~     Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the~     treatment of clinically evident ascites in participants with cirrhosis of the liver.~      Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment~     period in participants with cirrhosis of the liver and ascites.~      The one-year double blind placebo controlled period is extended up to 2 years in a long term~     safety study (PASCCAL-2).~   "
244167|NCT00358176|"~     To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per~     month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar~     spine in postmenopausal women with osteoporosis.~      To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in~     postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral~     neck and femoral trochanter and decreasing bone resorption.~      To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month~     as compared to 5 mg risedronate taken daily.~   "
244114|NCT00358865|"~     The purpose of this study is to check the usability of Virtual Reality (VR) Video Capture~     Projected System in children with acquired brain injury(ABI)and comparing their performance~     to the performance of normally developing children. The trial shall include 15 subjects in~     each group, aged 6-12 years old. ABI subjects are hospitalized at the hospital's Pediatric~     Rehabilitation Department Each subject will experience 3 different virtual environments. The~     subjects in the trial group will practice 3 experiences (3 times in 3 different days) during~     a period of a week to 10 days, to check the practice effect.In addition, all subjects will be~     tested in three tests: PEDI - to evaluate the functional abilities of daily living~     (dressing, eating...),The Melbourne Assessment - to evaluate functional movements of upper~     extremities, and the TEA-ch - to evaluate different attention abilities. Performance~     correlations will be tested between these tests and the performance in the VR first~     experience.~   "
244115|NCT00358852|"~     The purpose of this study is to establish and validate a scale/model that can be used to~     evaluate the duration of time and factors between short term hospital treatment and~     subsequent relapse periods in patients with schizoaffective/schizophreniform disorders.~   "
244116|NCT00358839|"~     The aim of the present study is to explore functional consequences of migraine gene mutations~     on their responses to Calcitonin Gene Related Peptide (CGRP)infusion.~   "
244117|NCT00358826|"~     This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various~     inflammatory biomarkers in patients with recent acute coronary events~   "
244118|NCT00358813|"~     The purpose of the study is to evaluate how subjects with mild or moderate kidney problems~     process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.~   "
244119|NCT00358800|"~     This study will evaluate the use of REMStar Auto with C-Flex (RSA C-Flex) therapy in subjects~     with previously diagnosed obstructive sleep apnea / hypopnea syndrome, during in-laboratory~     studies. The study will determine the ability of RSA C-Flex therapy to effectively treat the~     sleep apnea events. Mask leak and key sleep parameters will be monitored, and are expected to~     be improved with C-Flex vs. CPAP therapy. Satisfaction from both patient and technician will~     also be monitored.~   "
244120|NCT00358787|"~     Completely displaced (Type III) supracondylar fractures of the humerus are treated in the~     operating room and are held together with pins stuck into the bone. There are two ways of~     inserting the pins: crossed and laterally. The crossed method is often used because it is~     thought to be more stable, but this method also carries a risk of hitting the ulnar nerve. It~     is not known which method is more stable. Our hypothesis is that loss of reduction will be~     equivalent between the two pinning methods.~   "
244121|NCT00358774|"~     Common colds affect many people and are the cause of bothersome symptoms such as runny or~     stuffy nose, sore throat, headache and sneezing. Common colds can also cause more severe~     illnesses in certain groups of people like the elderly, people with chronic lung diseases~     such as asthma.~      This study is designed to test whether a non-drug (homeopathic) nasal spray will reduce the~     incidence of colds, decrease cold related symptoms or shorten the length of the cold.~   "
244122|NCT00358761|"~     This study will evaluate blood and tissue samples for a condition called Southern~     Tick-Associated Rash Illness (STARI). This is a skin rash resembling erythema migrans, the~     rash found in people infected with Lyme disease. In the south and southeastern United States,~     STARI is associated with the bite of the lone star tick. Researchers seek a better~     understanding of the cause of STARI. Through researchers' knowledge, diagnostic tests could~     be developed. NIH is conducting this study along with the Centers for Disease Control and~     Prevention (CDC).~      Patients ages 14 years and older who have recently been diagnosed with possible STARI, who~     have not taken antibiotics for it longer than 1 day, and whose skin does not form large scars~     may be eligible for this study. About 20 participants will be enrolled over a 5-year period.~     Patients will visit the NIH Clinical Center for two or three visits. The first visit may last~     2 hours. Photographs will be taken of the rash, and a blood sample of about 1-1/2 tablespoons~     will be collected for tests. Patients will undergo a punch biopsy of three small pieces of~     skin, from the rash. The area of the skin will be cleaned, and patients will receive a local~     anesthetic at the biopsy site. A sharp instrument will remove a round plug of skin, about the~     size of half a pencil eraser. Patients may feel a pushing sensation, but there should not be~     pain. The site usually heals without sutures, though the doctors may close it with special~     adhesive bandages or one or two sutures. Patients will receive instructions about how to take~     care of the biopsy site. If sutures are used, patients will return in 7 to 10 days to have~     them removed-or a patient's own doctor may remove the sutures. Patients will return to NIH at~     4 to 6 weeks following their first visit. At that time, they will answer questions about how~     they are doing and donate about 2 tablespoons of blood. Blood and skin samples will be used~     for research at NIH and CDC.~   "
244123|NCT00358748|"~     The purpose of this study is to investigate the early use of hydrocortisone in hypotensive~     very low birth weight infants.~      Based on the observations that:~        -  hypotension is a common problem in very low birthweight infants and is associated with~          brain injury and poor neurological outcomes;~        -  some infants are refractory to standard treatment (volume expansion and vasopressors),~          which is not exempt of adverse effects;~        -  relative adrenal insufficiency has been described in this population; we hypothesize~          that hydrocortisone is effective in the treatment of hypotension in this population and~          reduce the need for vasopressors.~   "
244124|NCT00358735|"~     Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin~     (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA~     surgery in comparison with LMWH.~   "
244125|NCT00358722|"~     Fermagate is a phosphate binder that absorbs phosphate from food, reducing the amount that~     the body can absorb.~      The purpose of this study it to look at the safety of fermagate over longer periods of time.~   "
244126|NCT00358709|"~     To verify the efficacy of a group cognitive-behavioral therapy approach to lessening~     psychotic symptoms of individuals with a first episode of psychosis, and to compare its~     effects to a known skills training approach and a control group. Our primary hypotheses were~     that CBT would do better than the control group at all points in time, and better than the~     skills training approach, though only at follow-ups~   "
244127|NCT00358696|"~     The primary purpose of this study is to evaluate the impact of changing didanosine in an~     effective anti-HIV regimen to tenofovir on virologic suppression. We hypothesize that, in~     patients with maximal virologic suppression on a double class regimen (including two NRTIs~     and an NNRTI or a PI, boosted with RTV or not), a single drug substitution of didanosine for~     tenofovir will represent a viable strategy without any negative impact on the virologic~     efficacy of the regimen.~   "
244529|NCT00353340|"~     The objective of this study is to assess the efficacy of sodium bicarbonate compared with~     sodium chloride and oral N-acetylcysteine (NAC ) pretreatment for prevention of contrast~     nephropathy in patients with advanced renal disease undergoing cardiac catheterisation.~   "
244129|NCT00358670|"~     This is a long-term, randomized, multi-center, open-label study of infliximab treatment in~     adults with moderate to severe plaque-type psoriasis. This study is the long-term extension~     of Study P04271 (NCT00251641); Study P04271 is a Phase 3b, randomized, parallel-group,~     multicenter, open-label, 26-week study comparing the efficacy and safety of infliximab versus~     methotrexate in the treatment of adult subjects with moderate to severe plaque-type~     psoriasis. The objectives of this study are to assess the efficacy and safety of long-term~     maintenance therapy versus intermittent therapy with 5 mg/kg infliximab in a moderate to~     severe plaque-type psoriasis population.~      During an interim safety evaluation of the trial, a higher incidence of serious and severe~     infusion reactions was observed in the intermittent treatment arm, consisting of a~     re-induction cycle (maximum of 4 infusions at 0, 2, 6 and 14 weeks) after a period of no~     treatment compared with the maintenance arm (infusions every 8 weeks without an interruption~     of treatment). Consequently, the sponsor has terminated the trial. The label will be updated~     to reflect this new information relating to the use of a re-induction regimen with~     infliximab.~   "
244130|NCT00358657|"~     This phase I/II trial studies the side effects of fludarabine phosphate, cyclophosphamide and~     total-body irradiation followed by donor bone marrow transplant and cyclophosphamide,~     mycophenolate mofetil, tacrolimus, and sirolimus in treating patients with primary~     immunodeficiency disorders or noncancerous inherited disorders. Giving low doses of~     chemotherapy and total-body irradiation before a bone marrow transplant helps prepare the~     patient's body to accept the incoming donor's bone marrow and decrease the risk that the~     patient's immune system will reject the donor's stem cells. When the healthy stem cells from~     a donor are infused into the patient they may help the patient's bone marrow make stem cells,~     red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a~     donor can make an immune response against the body's normal cells called graft versus host~     disease. Giving cyclophosphamide, mycophenolate mofetil, tacrolimus, and sirolimus after the~     transplant may help decrease this from happening.~   "
244131|NCT00358644|"~     The purpose of this study is to estimate the rate of complete remission, as well as overall~     survival, in older patients with Acute Myeloid Leukemia (AML).~   "
244132|NCT00358631|"~     The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and~     100 mg twice daily) compared to placebo and escitalopram 10 mg once daily in outpatients with~     major depressive disorder.~   "
244133|NCT00358618|"~     We are investigating a new technique for testing the effect of drugs on electrical activity~     in the heart. Disturbances of this electrical activity can cause life-threatening changes to~     heart rhythms. A better way of measuring the risk has recently been developed, and our~     research team leads the world in using this tool to test the safety of drugs used in~     children. Children and their families want to know that the drugs being used are safe, as do~     the doctors that care for them. In this study, we will take heartbeat tracings (ECGs) from 60~     children before and during their operations. The ECGs will then be checked by a children's~     heart specialist. Differences on the ECGs will be related to the presence and amount of drug~     (propofol) given. We expect that the propofol will not cause any changes that show increased~     risk of abnormal heart rhythms. We can then tell patients, parents and regulatory authorities~     of the safety profile of this aspect of the drug; moreover, the study can be used as a model~     for testing many other drugs used in hospitals.~   "
244134|NCT00358605|"~     This study will look at whether patients with OSAHS already successfully treated with nasal~     CPAP could successfully use an oral appliance as a short-term treatment alternative and~     whether patients who could use an oral appliance as an alternative would actually avail of~     its use, and to assess their preference in terms of treatment modality. The combination of~     therapies if tolerated, will allow greater flexibility of treatment and opportunity for~     ongoing compliance in circumstances where CPAP cannot be used.~   "
244135|NCT00358592|"~     This is a randomized controlled trial comparing the use of the Mobius™ retractor to the use~     of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women.~     The Mobius™ retractor was designed for abdominal surgery to improve visualization of the~     surgical field through standard surgical incisions and is now a standard instrument used for~     cesarean deliveries at Thomas Jefferson University Hospital. We hypothesize that the use of~     the Mobius™ retractor during cesarean deliveries in obese women decreases operative time,~     blood loss, number of transfusions, infectious morbidity, incision length, and intra- /~     post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.~   "
244136|NCT00358579|"~     The effectiveness of medications in cardiac arrest has been greatly debated and questioned.~     Historically intravenous adrenaline has been the drug of choice since 1906. There have been~     few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical~     trials have not been able to show any benefit with intravenous adrenaline (compared to~     placebo or no treatment) in the field.~      Thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of~     cardiac arrest to answer the question whether there is an improvement in survival between~     vasopressin and adrenaline.~   "
244137|NCT00358566|"~     To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally~     advanced and metastatic adenocarcinoma of the pancreas.~   "
244138|NCT00358553|"~     The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of~     recombinant human insulin. The study will consist of 2 phases.~   "
244139|NCT00358540|"~     The study will evaluate the safety and tolerability, optimal biologic dose, and~     pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet~     count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.~   "
244140|NCT00358527|"~     This study will hope to show that by relieving the participant's nasal symptoms of seasonal~     allergies using mometasone furoate nasal spray, the participant will obtain a better quality~     of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can~     function productively during the day.~   "
244168|NCT00358163|"~     PTK787/ZK 222584 is an inhibitor of VEGFR family tyrosine kinases. The primary objective of~     this study is to assess the safety of daily oral PTK787/ZK 222584 in combination with~     paclitaxel infused every 21 days. Secondary objectives include pharmacokinetic assessment of~     the impact of PTK787/ZK 222584 on paclitaxel metabolism and evaluation of tumor response to~     the investigational treatment.~   "
244141|NCT00358514|"~     This study has been designed to allow us to learn more about diagnosing Compartment Syndrome,~     which is a condition that occurs in approximately 5% of tibial (lower leg) fractures. In~     Compartment Syndrome, nerves, muscle and blood vessels are affected by swelling within the~     enclosed spaces (compartments) of the leg. The tissue covering these compartments (called the~     fascia) is not expandable and is not able to accommodate this swelling, and so the tissues~     within the compartments become compressed. If the pressure is not relieved it can result in~     blood flow being blocked to the inside of the compartment (muscle, blood vessels, and nerves)~     which can lead to permanent injury to the muscle and nerves. Late complications in untreated~     compartment syndrome include a failure of the injured bone to heal, nerve damage, and~     contracture (shortening) of muscle, all of which can result in a weak, painful, stiff, and~     poorly formed limb that is not functioning well, and could result in amputation.~   "
244142|NCT00358501|"~     The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25~     mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2)~     evaluate serum and endothelial markers of veno-occlusive disease (VOD) through the analysis~     of blood samples.~   "
244143|NCT00358488|"~     This study is designed to determine the efficacy and safety of a new long-acting beta-agonist~     for asthma patients (GSK159797) following dosing for 14 days.~   "
244144|NCT00358475|"~     This study was designed to assess safety of an investigational nasal spray in the treatment~     of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite~     and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.~   "
244145|NCT00358462|"~     The purpose of this study is to find out which of 2 different antibiotics, doxycycline or~     azithromycin, works best against germs that may cause nongonococcal urethritis.~      Study participants will include approximately 1200 men, 16 years of age or older, attending a~     sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral~     inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a~     visible urethral discharge upon examination).~      Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each~     participant will receive a blinded packet of study medication. Participants will answer an~     enrollment questionnaire and will also receive a log to complete between visits to record~     information about treatment adherence, side effects, symptoms, and sexual activity. All~     subjects will be asked to return for evaluation 3 weeks after the initial clinic visit.~     Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit~     will also be asked to return for a third study visit, 6 weeks following the initial clinic~     visit. During follow-up visits, participants will answer a follow-up questionnaire and will~     be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium~     and/or Ureaplasmas will be re-tested for these organisms.~      Study participants with signs and/or symptoms of urethritis or who test positive for M.~     genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment~     packet containing the alternate medication. Those who require additional treatment at the~     6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study~     participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic~     visit, but who continue to demonstrate signs and/or symptoms of infection at their single~     follow-up study visit will treated according to clinic standard of care (after the study~     clinician unblinds their randomly-assigned treatment regimen).~   "
244146|NCT00358449|"~     This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.~   "
244147|NCT00358436|"~     To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with~     moderate to severe COPD during one year of treatment.~   "
244148|NCT00358423|"~     This research is being done to look at the effects of an experimental drug called pegaptanib~     (also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue~     in the back of the eye) that can occur after cataract surgery. Swelling in the retina can~     lead to blurry vision.~      The only treatment available for this condition is eye drops that decrease swelling in the~     back of the eye, but eye drops may not decrease the swelling in everyone. We want to see if~     pegaptanib can decrease swelling in the retina and improve vision in patients with swelling~     after cataract surgery.~   "
244149|NCT00358410|"~     This study was designed is to examine the idea that GW679769 has an effect on three of the~     pathophysiological disturbances reported in patients with Functional Dyspepsia (FD): impaired~     stomach accommodation to a meal, delayed stomach emptying, and visceral hypersensitivity to~     distension.~   "
244150|NCT00358397|"~     This study will include a one time intravenous (IV) infusion of Clostridium novyi-NT (C.~     novyi-NT) spores to treat solid tumors which have not responded to standard therapy.~   "
244151|NCT00358384|"~     This study is an exploratory study to evaluate the effectiveness, safety and tolerability of~     three concentrations of GW786034 ointment following treatment to small areas of stable~     psoriatic plaques. Dosing will proceed using a microplaque approach, where small volumes of~     ointment will be applied under full occlusion to representative psoriatic plaques. The~     effectiveness of topical GW786034 treatments and controls will be explored using visual~     intensity assessments in addition to dermal imaging and histological surrogates of disease~     activity.~   "
244152|NCT00358371|"~     Primary objective:To study the absolute bioavailability, distribution and elimination~     parameters of flucloxacillin from two oral formulations of flucloxacillin in healthy male~     and/or female subjects.~   "
244153|NCT00358358|"~     This study will last for approximately 14 weeks and will involve 5 visits. The study is being~     carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD~     is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can~     include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient.~     The effects of drug treatment are usually measured by conducting lung function tests~     (breathing tests) using a machine called a spirometer but this does not always provide a~     complete picture of how well your COPD is responding. In this study we therefore want to look~     at new and more sensitive ways of measuring COPD. The results of this research will help in~     the assessment of new drugs for COPD in the future.~   "
244154|NCT00358345|"~     The primary objective of this study is to assess the ability of the PreView PHP(study~     device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion~     associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate~     them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no~     CNV.~      This study secondary is to enhance NotalVision normative database.~   "
244184|NCT00357955|"~     The purpose of this research is to study whether a multidisciplinary education in Diabetes~     and intervention for cardiac risk reduction in a group setting to modify patient behavior and~     adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and~     lipid control.~   "
244155|NCT00358332|"~     The purpose of this study is to test the safety and dosages of a malaria vaccine in 100~     children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine~     when it is given to people who are regularly exposed to malaria and it will provide~     information regarding optimal vaccine dosage. This study will compare 3 injections of~     different vaccine doses to a rabies vaccine that is already approved. During the study, the~     child's health will be checked in the clinic and during home visits. Children may participate~     for about 14 months, and blood will be taken from each child throughout the study. If the~     child becomes sick from malaria, he/she will be treated. Information from this study may be~     used to develop a malaria vaccine that will help control the disease.~   "
244156|NCT00358319|"~     This is a Phase I study looking at the combination of Valproic Acid (VPA) and Karenitecin to~     treat patients with metastatic malignant melanoma. We will find the dose-limiting toxicity~     (DLT) and the highest dose (maximum tolerated dose) of this combination treatment that has~     acceptable side effects and recommend a Phase II dose level.~      There will be seven escalating doses of Valproic acid and one dose escalation step of~     Karenitecin. Each patient shall receive one cycle of Karenitecin alone (cycle 1 days 1 - 5)~     followed by the same dose of Karenitecin given in combination with VPA (cycle 2 days 1-7).~     Patients will receive oral VPA in divided doses for 5 days and Karenitecin starting on the~     3rd day every 3 weeks (a treatment cycle).~      Treatment will continue until progression of disease or an unacceptable level of toxicity.~     After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the~     disease. In the absence of disease progression and if there is continued safety and~     tolerability, treatment may continue.~   "
244157|NCT00358306|"~     To understand how AKI (Acute Kidney Injury) leads to chronic kidney disease so therapies can~     be found to alter the progression of events thereby significantly impacting the long-term~     outcomes of children who develop AKI.~   "
244158|NCT00358293|"~     Nightly administration of 8 mg of a unique sublingual (under the tongue) formulation of~     tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve~     next-day spasticity, about 12 hours following dosing in 20 multiple sclerosis (MS) patients.~     This improvement was statistically significant when compared to oral tizanidine dosing. The~     current study is being undertaken to see if increasing the dose to 12 mg once nightly will~     result in an even greater improvement, with a longer effect, i.e., next day improvement in~     spasticity both in the morning as well as in the late afternoon.~   "
244159|NCT00358280|"~     The purpose of this study is to compare the efficacy, duration of motor block until return to~     normal function in the non-operated leg after the start of injection, of ropivacaine 5 mg/ml~     and bupivacaine 5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral~     lower limb surgery.~   "
244160|NCT00358267|"~     Turbinates are large structures in the nasal airway that help the nose to clean and humidify~     the air we breathe. Inferior turbinates can swell up and block the breathing passage, making~     it hard to breath. To address this, turbinate size must be reduced.~      This study looks at two common procedures for turbinate reduction:~        1. Radiofrequency Ablation (RFA) involves inserting a special needle into the inferior~          (lower) turbinate that releases thermal energy, which significantly reduces its size.~          This can be done under local anesthesia at the doctor's office.~        2. Partial Resection of Inferior Turbinate (PRIT) involves surgically removing a piece off~          the turbinate, which also reduces its size.~      While both procedures improve nasal obstruction, no study has directly compared which is more~     effective.~      Eighty patients being treated for septal deformity and turbinate hypertrophy will be randomly~     chosen for either PRIT or RFA treatment. They will fill out a simple, five question survey~     that measures how they view their nasal blockage 4 times in one year. We believe that since~     PRIT permanently removes a part of the turbinate, PRIT patients will report more improvement~     than RFA patients one year later. We believe that complications (measured by the doctor) will~     be the same for both treatments.~   "
244161|NCT00358254|"~     The objective of this study is to assess the performance of a noninvasive device for the~     early screening of Diabetes Mellitus.~   "
244162|NCT00358241|"~     Early physical therapy after knee surgery is very painful on top of pain from surgery. Pain~     following surgery can limit recovery. One way to treat pain is by giving intravenous (IV)~     pain medication with morphine. Another method is to use a “nerve block” which involves~     placing a thin catheter (tube) into the lower back near the nerves that sense pain in the~     knee and give a local anesthetic to numb the nerves. Sometimes both methods are used~     together. This research is being done to determine whether nerve blocks with a local~     anesthetic improve knee recovery in addition to providing pain relief as compared to IV pain~     medicine alone~   "
244163|NCT00358228|"~     The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus~     placebo on abstinence from tobacco use in cigarette smokers.~      The secondary study objectives were:~        -  To evaluate the effects of rimonabant on craving and weight;~        -  To evaluate the clinical and biological safety and tolerability of rimonabant in a~          population of cigarette tobacco smokers during a 10-week treatment period~        -  To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in~          the population of smokers);~        -  To observe the percentage of abstinent patients during a 40-week follow-up post~          treatment period;~        -  To evaluate quality of life (QOL) and pharmacoeconomics.~   "
244164|NCT00358215|"~     The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin~     alfa compared to placebo on the composite of time to death from any cause or first hospital~     admission for worsening heart failure in patients with symptomatic left ventricular systolic~     dysfunction and anemia.~   "
244165|NCT00358202|"~     Randomized trial of nursing home residents with pneumonia to assess if intramuscular cefepime~     is a safe, efficacious, and cost-effective alternative to once daily intramuscular~     ceftriaxone for the treatment of elderly nursing home residents who develop pneumonia and do~     not require hospitalization.~   "
244166|NCT00358189|"~     The purpose of this study is to assess the effects of unilateral deep brain stimulation on~     upper and lower extremity motor function in advanced Parkinson's disease patients. It is~     hypothesized the unilateral stimulation will lead to improvements in bilateral motor~     functioning.~   "
244905|NCT00348322|"~     The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783~     in comparison to Refresh Tears Lubricant Eye Drops (Allergan) in a specified population of~     dry eye patients.~   "
244169|NCT00358150|"~     Gaucher disease is a genetic disease that results in a deficiency of an enzyme acid~     beta-glucosidase, also known as glucocerebrosidase. This enzyme is needed to digest a~     substrate (lipid) called glucosylceramide and, to a lesser degree, glucosylsphingosine. In~     participants with Gaucher disease, the liver, spleen, bone marrow and brain show increases in~     lipid concentration, specifically in cells derived from the monocyte/macrophage system.~      Eliglustat tartrate (Genz-112638) is an oral drug that may regulate the Gaucher disease~     process by decreasing the synthesis of glucosylceramide. The primary objective of this study~     is to evaluate the efficacy, safety and pharmacokinetics (PK) of eliglustat tartrate,~     administered as an oral dose of either 50 milligram (mg) twice daily (BID) or 100 mg BID, to~     men and women with Gaucher disease Type 1 for 52 weeks.~   "
244170|NCT00358137|"~     This study will evaluate the effect of an aerobic training program versus a strength training~     program on the autonomic nervous system at rest and in response to challenge.~   "
244171|NCT00358124|"~     To compare the glycemic control, as measured by HbA1C, between insulin glargine and~     rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and~     metformin~   "
244172|NCT00358111|"~     This is a post-approval, multi-center, single-arm study (n=950) designed to address the~     relationship of the LUMA device performance to patient age, patient human papillomavirus~     (HPV) status and colposcopist experience.~   "
244173|NCT00358098|"~     This study of hormone positive (estrogen receptor [ER]), metastatic invasive ductal breast~     cancer looks at functional scanning using positron emission tomography (PET) and patient~     response to hormone therapy. Functional scans allow investigators to see more than one~     metastatic location. The investigators will use an estrogen based agent (FES) to see the~     number of hormone positive metastases and compare that to positive lesions on routine glucose~     (FDG) based scanning.~      FES and FDG-PET results will be compared to give a FDG to FES ratio. The PET ratio will be~     calculated before hormone therapy and at relapse after treatment. The investigators will~     biopsy an accessible lesion that is FDG positive and FES negative and perform pathological~     testing for ER and PR positivity and compare it to the original primary tumor ER/PR. The~     investigators will test the lesion for tumor proliferation (using Ki-67) and aggressiveness~     using human epidermal growth factor receptor 2 (HER-2). Results will be compared to the~     primary tumor Ki-67 and HER-2 to determine concordance.~      The investigators will have pre-treatment results for FES and FDG-PET, will calculate the~     ratio, and will correlate it to the primary metastatic lesion and test for ER/PR, Ki-67, and~     HER-2, and subsequent response to therapy. The investigators will determine the FES-PET~     predictive value for determining appropriateness of hormone therapy for metastatic disease.~     With these results, the investigators plan to undertake future tumor biomarker/PET studies in~     metastatic breast cancer.~   "
244174|NCT00358085|"~     Objectives.~      To study the feasibility of an expertise-based randomized controlled trial (RCT) testing the~     role of traditional surgery (OPEN) versus endovascular repair (EVAR) for abdominal aortic~     aneurysms (AAA).~      Study design.~      We will conduct an expertise-based RCT comparing OPEN to EVAR of non-urgent abdominal aortic~     aneurysms in patients referred to vascular surgeons practicing at Hamilton Health Sciences,~     to determine the rate of death and other complications. Quality of life and status at 6~     months will also be recorded. The ultimate goal is to determine the feasibility of conducting~     a pragmatic expertise-based RCT and to inform a future larger study at a national level.~   "
244175|NCT00358072|"~     The study aims to optimize the concept of risk-oriented postremission consolidation therapy,~     by offering (i) standard consolidation-maintenance to patients at lowest risk of relapse as~     defined by MRD(Minimal Residual Disease) negative status, and (ii) allogeneic stem cell~     transplantation (related/unrelated donor available) or multicycle high-dose therapy with~     autologous blood stem cell transplant (no donor) to patients at highest risk of relapse as~     defined by MRD+ status.~      The prognostic role of MRD evaluation in unselected patients will be evaluated.~   "
244176|NCT00358059|"~     Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to~     work together effectively to solve problems and resolve disagreements in order to achieve~     acceptable diabetic control and treatment adherence. Many studies show that problematic~     family communication, insufficient parental involvement in care and parent-adolescent~     conflict are associated with poor adherence and poor diabetic control. This study tests a~     family communication and problem solving intervention by randomizing families of adolescent~     with type 1 diabetes to 6 months' treatment either with the experimental intervention,~     continuation in standard medical care for diabetes, or participation in a multifamily~     educational support group. Families are then followed for an additional 12 months to examine~     the longer-term effects of the interventions on the targeted diabetes outcomes.~   "
244177|NCT00358046|"~     This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease~     patients with hyperphosphatemia on hemodialysis. Patient participation in the study is~     approximately 10 weeks in duration.~   "
244178|NCT00358033|"~     The purpose of this study is to determine whether a combined behavioral and pharmacological~     intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and~     Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.~   "
244179|NCT00358020|"~     The purpose of this study is to evaluate the safety and the efficacy of the association of~     Melphalan/Prednisone/Thalidomide/VELCADE (MPTV) as salvage treatment in advanced and~     refractory myeloma patients. This association might further increase the response rate~     achieved by the standard oral MP regimen.~   "
244180|NCT00358007|"~     To evaluate the use of cone beam computed tomography in treating head and neck to hopefully~     reduce side effects~   "
244181|NCT00357994|"~     The primary objective of this study was to demonstrate the superiority of levodopa -~     carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12~     weeks.~   "
244182|NCT00357981|"~     Dr. Eleanor Drey in the Department of Obstetrics, Gynecology and Reproductive Sciences UCSF~     is conducting a study to examine the personal and economic impact of continuous use of ORTHO~     EVRA, the contraceptive patch, on menstrual related symptoms for women who report having~     severe menstrual related symptoms.~   "
244183|NCT00357968|"~     The purpose of this study is to provide information of the relative potency of prasugrel and~     clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects~     undergoing elective percutaneous coronary intervention (PCI).~   "
244185|NCT00357942|"~     Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often~     associated with painful ulcers in the mouth. The study hypothesis is that morphine~     administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect.~      The purpose of this study is to test the analgesic effect of a morphine mouthwash versus~     morphine injections or placebo (no active drug) in children/adolescents with stomatitis~     related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine~     injections) the children/adolescents receive a standardized analgesic treatment for~     stomatitis-related pain.~   "
244186|NCT00357929|"~     Some patients receiving mechanical ventilation have difficulty weaning off the ventilator~     because of physiological factors such as pre-existing lung disease, respiratory distress~     syndrome, and trauma among others. Allowing patients to become hypercarbic (increased blood~     bicarbonate level) may make it easier for these patients to be taken off the ventilator and~     resume breathing on their own.~   "
244187|NCT00357916|"~     To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on~     normal skin~      To evaluate skin irritation~   "
244188|NCT00357903|"~     This study was designed to provide all adult and pediatric arthritis patients (placebo and~     etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept~     (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The~     primary objective of this study is to examine safety parameters.~   "
244189|NCT00357890|"~     Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years~     old) will be randomized to either receive multiple daily injection (MDI) using Lantus~     insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed~     protocol compares the changes in diabetes control between pump therapy and MDI treatment~     groups. More importantly, however, the study evaluates how these modes of therapy may affect~     the honeymoon period and glycemic control, specifically focusing on changes in insulin~     sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin~     concentration changes) and beta cell function (measured by mixed meal tolerance testing).~     Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the~     honeymoon phase by improving insulin sensitivity and beta cell function may have important~     therapeutic implications that could influence the standard of care in pediatric diabetes.~   "
244190|NCT00357877|"~     Adult tooth decay is an infectious disease that afflicts the majority of Americans aged 55~     and older and is the most common chronic disease at midlife with an ever growing economic~     toll. Despite the fact that specific bacteria cause tooth decay, no FDA-approved~     anti-microbial treatment for decay is available to the American dental professional. The~     Prevention of Adult Caries Study (PACS) is a study designed to evaluate the efficacy of a~     topical, temporary, 10% w/v chlorhexidine dental coating in reducing new decay in adult~     dental patients at risk for decay.~   "
244191|NCT00357864|"~     To investigate headache score and accompanying symptoms during and after infusion of~     carbachol.~   "
244192|NCT00357851|"~     Pancreatitis is caused by an acute injury on the pancreas. This illness is associated with~     abdominal pain, vomiting or even fever. We have recently reported a high rate of acute~     pancreatitis developing in children who undergo posterior spinal fusion for scoliosis (to~     correct spinal curve). We showed that the amount of blood loss during the surgery is related~     to the incidence of pancreatitis. In addition, some markers that monitor tissue injury are~     elevated after the surgery and significantly higher in the patients who develop acute~     pancreatitis later. We propose that if blood loss and tissue injury could be reduced, then~     the incidence of pancreatits may be less in these children. Therefore we plan to use a drug~     Aprotinin to just do that. Aprotinin has been used to reduce blood loss in patients~     undergoing posterior spinal surgery, the same population we propose to study. If it turns out~     that Aprotinin can reduce blood loss or/and the damage to the pancreas, thus pancreatitis, it~     will diminish the pain and discomfort, and shorten hospital stay in these children. The~     results from this study will guide medical care in these children in the future.~   "
244193|NCT00357838|"~     We hypothesized that there's difference between follicular phase and luteal phase of normal~     women in radial pulse waves and tongue figures.~   "
244194|NCT00357825|"~     The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in~     patients with fibromyalgia.~   "
244195|NCT00357812|"~     The aim of this study is to compare the safety, specificity, sensitivity and ease of~     procedure of two potential diagnostic assays for HSV-1 detection in the cornea. Through the~     use of this new diagnostic assay, correct and early intervention would not only reduce~     corneal scarring from HSK, but it would also allow the initiation of appropriate treatment~     for HSV mimicking keratitis.~      HSV-1 infection of the eye can result in corneal scarring and blindness. Early diagnosis of~     this condition and appropriate treatment is of utmost importance. Various ocular surface~     conditions can mimic herpetic keratitis in their clinical presentation and can result in~     diagnostic confusion. Inappropriate or delayed treatment of herpetic corneal disease results~     in increased morbidity.~      In the UK at present clinical presentation is the mainstay of diagnosis. Unfortunately these~     cases often present to the most inexperienced clinical staff resulting in variability in~     diagnostic acumen. This often results in a delay or inappropriate diagnosis of herpetic~     keratitis. Laboratory techniques presently available to aid diagnosis are infrequently used~     in clinical practice. There are various reasons for their lack of use. Historically viral~     culture techniques were the mainstay of investigation but were slow, requiring weeks to~     provide a result. PCR is now replacing culture techniques and is relatively quick, reliable~     and sensitive. Many clinicians within the UK are still not fully informed of these advances~     and are therefore not utilizing these techniques to supplement clinical diagnosis.~      We propose to investigate the use of topically applied fluorescent antibody against active~     replicating HSV-1 in a droplet form and real time PCR detection of the virus. If successful~     this should increase the potential diagnostic capabilities of GPs and other less experienced~     health care workers. Such tests should reduce variability in diagnosis and the dependency on~     experienced ophthalmologists to diagnose the condition.~   "
244205|NCT00357682|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of esomeprazole and aspirin may prevent esophageal cancer in patients~     with Barrett's metaplasia. It is not yet known whether esomeprazole is more effective with or~     without aspirin in preventing esophageal cancer in patients with Barrett's metaplasia.~      PURPOSE: This randomized phase III trial is studying esomeprazole with or without aspirin to~     compare how well they work in preventing esophageal cancer in patients with Barrett's~     metaplasia.~   "
244206|NCT00357669|"~     The study will compare the efficacy and safety of brivaracetam with placebo in patients with~     Unverricht-Lundborg disease.~   "
244230|NCT00357357|"~     The purpose of this Phase II study is to evaluate the safety and tolerability of HF 0220 in~     patients with Alzheimer's disease compared to placebo (inactive substance). The study will~     also validate biochemical markers as appropriate clinical end-points and to assess the~     suitability of chosen dose levels for future clinical studies.~   "
244196|NCT00357799|"~     Hypothesis: The first attempt success rate for peripheral IV insertion for children with~     difficult IV access (difficult IV access [DIVA] score ≥ 4) by nurses using the VeinViewer~     guided technique is better than conventional method of IV placement.~      Specific Aims:~        1. To investigate if use of the VeinViewer can improve the success of peripheral IV~          placement in children with difficult IV access~        2. To validate the DIVA score~      Design: Prospective randomized controlled trial/Convenience sample~      Subjects: Children (0-18) presenting to the emergency department who require an IV as~     determined by examining physician and with a DIVA score ≥ 3 during times when VeinViewer~     machine is available and a VeinViewer trained participating nurse is on duty.~      Variables:~      Outcome Variables: First IV attempt success rate~      Predictor Variables: IV technique used, other potential modifiers (age, weight, height, skin~     shade, indication for IV, history of prematurity and, vein visibility/palpability after~     tourniquet)~      Methods: Subjects who meet inclusion criteria will be randomized to either conventional IV~     technique or VeinViewer guided technique. The nurse will attempt the IV depending on the~     randomization. Success or failure on first IV attempt will be recorded. If unsuccessful,~     other attempts will be tried until a successful IV is placed or the physician decides to give~     an alternative therapy that does not need IV access.~      Statistics: A chi square test will be used to compare the proportion of subjects with~     successful first attempt IV placement using the VeinViewer technique to that using the~     conventional method with 95% confidence interval. We, the researchers, will look at the~     median number of attempts to place an IV in each of the groups. Logistic regression will be~     performed to test for independent associations. Information collected during the study will~     also be used for validation of the DIVA score.~      Risks: No extra risks are expected above that of receiving a standard IV. The standard risk~     of bleeding, bruising, pain, and infection will be possible regardless of technique used. The~     VeinViewer does not expose the patient the ionizing radiation. The use of the VeinViewer~     technique may increase the time need to place an IV in.~      Potential Benefits: With this study, we, the researchers, hope to improve the success rate of~     children with difficult IV placement in the Emergency Department.~   "
244197|NCT00357786|"~     This study will continue to evaluate the safety of using intravenous doses of Replagal for~     two patients with Fabry disease. Fabry disease is a genetic disorder inherited as an X-linked~     recessive trait. It causes a deficiency in the enzyme alpha galactosidase, which normally~     breaks down a lipid, or fatty substance called ceramidetrihexoside, a building block in all~     cells of the body. The deficiency in breaking down the lipid eventually causes that lipid to~     accumulate and injure cells. Vascular, renal, and neurological problems are the results. It~     is not known exactly how lipid accumulation brings about such problems, studies of another~     lipid storage disorder.~      Two patients 7 to 17 years of age who have Fabry disease and have been receiving intravenous~     infusions of Replagal at a dose of 0.2 mg/kg of body weight every 2 weeks may be eligible for~     this study.~      Participants will undergo the following tests and procedures:~        -  Physical examination.~        -  Neurological examination.~        -  Medical and medication history.~        -  Vital signs.~        -  Assessment of height and weight.~        -  Blood tests to determine complete blood count and chemistries.~        -  Electrocardiogram.~        -  Doppler blood flow study.~      Participants will go through a baseline evaluation, over a period of about 1 day. They will~     receive an intravenous infusion of Replagal every other week, at the dose of 0.2 mg/kg of~     body weight. Vital signs will be measured before the infusion and immediately and after and 1~     hour afterward. There will be careful monitoring for allergic reactions and side effects. The~     infusion time takes approximately 40 minutes.~      This study will last at least 1 year, or until the sponsor doing the investigating or the~     drug manufacturer decides to withdraw support of the study.~   "
244198|NCT00357773|"~     To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for~     the treatment of purulent bacterial conjunctivitis, and to assess the safety~   "
244199|NCT00357760|"~     This randomized phase II trial studies how well ziv-aflibercept (VEGF Trap) works in treating~     patients with kidney cancer that has spread from the primary site to other places in the body~     (metastatic) or is unable to be removed with surgery (unresectable). Ziv-aflibercept may stop~     the growth of kidney cancer by blocking blood flow to the tumor.~   "
244200|NCT00357747|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug.~      PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given~     together with docetaxel in treating patients with solid tumors.~   "
244201|NCT00357734|"~     The purpose of this study is to assess the long-term safety profile and the secondary~     objective to estimate clinical benefit of ZD1839 (gefitinib).~   "
244202|NCT00357721|"~     The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir~     administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg,~     given once daily.~   "
244203|NCT00357708|"~     This phase I trial is studying the side effects and best dose of vorinostat and decitabine in~     treating patients with relapsed, refractory, or poor-prognosis hematologic cancer or other~     diseases. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving vorinostat together with decitabine may kill more cancer cells~   "
244204|NCT00357695|"~     This study will examine the parts of the brain that use visual information to perform~     movements. Patients with certain brain lesions tend to have difficulty in processing visually~     presented objects. This study will look at the brain mechanisms underlying the visuo-motor~     integration.~      Healthy normal volunteers between 20 and 60 years of age are eligible for this study. People~     who have had a severe head injury with loss of consciousness or any other mental or~     neurological disorder diagnosed by a doctor may not participate. Candidates will be screened~     with a medical history, a physical examination focusing on finger movements, and a~     questionnaire.~      Participants' brain activity will be recorded using two techniques -~     magnetoencephalography(MEG) and magnetic resonance imaging (MRI) - while they watch pictures~     of various objects flashed on a screen. MEG is a procedure to record magnetic field changes~     produced by brain activity. During the recording, the subject sits comfortably in an armchair~     in a dimly lit room and watches pictures presented on a screen. About 50 pictures are shown~     per session. There are about five sessions, separated by 3-minute breaks. Functional MRI~     involves taking pictures of the brain using MRI while the subject performs a task. MRI uses a~     strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI~     scanner is a metal cylinder surrounded by a magnetic field. The subject lies still on a table~     that can slide in and out of the scanner. During the scan, he or she looks at pictures in six~     test blocks of 1 minute each, with 30-second breaks between blocks.~   "
244228|NCT00357383|"~     To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one~     instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day~     2).~      To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day~     treatment period~   "
244207|NCT00357656|"~     The purpose of this study is to compare the hemostatic efficacy and safety of continuous~     infusion versus intermittent bolus infusion in the peri- and post-operative setting,~     employing rAHF-PFM, a recombinant antihemophilic factor manufactured without added human or~     animal proteins, in previously treated patients with severe or moderately severe hemophilia A~     (baseline factor VIII level <= 2% of normal) who are undergoing unilateral major orthopedic~     surgery that requires drain placement. The total study period per subject (from consent to~     study completion) will vary from approximately 9 to 26 weeks and will involve clinical and~     laboratory assessments.~   "
244208|NCT00357643|"~     The primary aim of this study is to determine the effects of supplementation with both~     calcium and vitamin D on changes in bone density of the hip in men and women age 65 and~     older.~   "
244209|NCT00357630|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with~     metastatic cancer of unknown primary.~   "
244210|NCT00357617|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Giving celecoxib before~     surgery may reduce the amount of normal tissue that needs to be removed. Collecting and~     storing samples of tumor tissue, blood, and urine from patients with head and neck cancer to~     study in the laboratory may help doctors learn more about the cancer and predict how well~     patients will respond to treatment with celecoxib.~      PURPOSE: This phase I/II trial is studying changes in tumor cells and how well celecoxib~     works in treating patients with head and neck cancer that can be removed by surgery.~   "
244211|NCT00357604|"~     The purpose of this study is to administer a combined oral contraceptive (ethinyl estradiol~     and norgestimate) with the HIV treatment of atazanavir and ritonavir to healthy females in~     order to assess if the concentrations of the oral contraceptive change. The safety of this~     treatment regimen will also be studied.~   "
244212|NCT00357591|"~     The Company's proprietary products are based on Orqis Medical's hypothesis, supported by~     early clinical data, that increasing and maintaining continuous blood flow in the descending~     aorta, known as continuous aortic flow augmentation or CAFA, improves hemodynamics in heart~     failure patients. The clinical impact of the hemodynamic improvement is currently being~     evaluated to determine the effects of CAFA on stopping or reversing the progression of heart~     failure through three physiological effects:~        -  VASCULAR - Reducing systemic vascular resistance~        -  RENAL - Improving renal function~        -  CARDIAC - Reducing cardiac workload~   "
244213|NCT00357578|"~     This study will examine skin and blood cells for genetic changes related to the development~     of age-related macular degeneration, an eye disease that can significantly impair the ability~     to read, drive, and carry out daily activities. It is the most common cause of vision loss in~     people over the age of 50.~      People with age-related macular degeneration and healthy normal volunteers age 50 years or~     older may be eligible for this study. Candidates will undergo a medical history, physical~     examination and eye examination with dilation of the pupils. Photographs of the eye will be~     taken with a special camera.~      Study participants will have blood drawn three times (no more than 6 tablespoons each time)~     and will undergo three skin biopsies. For the skin biopsy, an anesthetic is injected under~     the skin and a small piece of skin-approximately 1/4-inch cube-is removed. The blood draws~     and biopsies will be done at 7- to 10-day intervals. In most cases, a single biopsy is done~     at each visit, but it may be necessary to take-at most-one additional biopsy from the other~     arm during the same visit. Patients will return for one follow-up visit 7 to 10 days after~     the last biopsy for examination of the biopsy site and removal of any stitches.~      The results of this study may provide investigators information needed to develop new means~     of diagnosing and treating age-related macular degeneration.~   "
244214|NCT00357565|"~     RATIONALE: Giving chemotherapy, such as busulfan, fludarabine, and melphalan, before a donor~     umbilical cord blood stem cell transplant helps stop the growth of abnormal or cancer cells~     and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a~     donor are infused into the patient they may help the patient's bone marrow make stem cells,~     red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a~     donor can make an immune response against the body's normal cells. Giving cyclosporine and~     mycophenolate mofetil may stop this from happening.~      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by a~     donor umbilical cord blood transplant works in treating infants with high-risk acute leukemia~     or myelodysplastic syndromes.~   "
244215|NCT00357552|"~     Most anti-HIV regimens include a non-nucleoside reverse transcriptase inhibitor (NNRTI);~     however, some individuals fail on these regimens. The purpose of this study is to evaluate~     the safety and effectiveness of the protease inhibitor (PI) lopinavir/ritonavir (LPV/r) in~     HIV infected individuals who are failing an anti-HIV regimen that includes an NNRTI.~   "
244216|NCT00357539|"~     To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5%~     - 1.0% - 1.5%) and the vehicle of T1225.~   "
244217|NCT00357526|"~     The purpose of this study is to determine whether teens and young women would prefer the~     Nuvaring to oral contraceptive pills after having tried both methods.~   "
244218|NCT00357513|"~     This study will characterize the gene response of the body's immune and inflammatory cells to~     stroke. There is a wide variation in stroke risk, stroke outcome, and response to~     clot-busting therapy for stroke. This variation may be due to differences in people's~     response to injury or infection, or to differences in genetic make-up between individuals.~     Genes store the biological information that determines the body's response to injury or~     infection. This study will analyze the activity of a large number of genes to try to learn~     which genes might be related to patient outcome. This, in turn, may lead to an understanding~     of which gene profiles are related to increased stroke risk and increased disability or~     death.~      Healthy volunteers over age 21 and stroke patients over age 21 who are admitted to the NIH~     Stroke Program at Suburban Hospital in Bethesda, Md., may be eligible for this study.~     Volunteers will be screened with a medical history, blood pressure and pulse measurements,~     electrocardiogram, and neurological examination.~      Participants will have 20 to 35 milliliters (about an ounce) of blood drawn for genetic~     studies. The genetic material will be extracted from the white blood cells and analyzed for~     normal and abnormal gene activity related to stroke.~   "
244219|NCT00357500|"~     RATIONALE: Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Thalidomide, celecoxib, and fenofibrate may stop the growth of cancer~     cells by blocking blood flow to the cancer. Celecoxib also may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy~     together with thalidomide, celecoxib, and fenofibrate may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving etoposide and cyclophosphamide~     together with thalidomide, celecoxib, and fenofibrate works in treating young patients with~     relapsed or progressive cancer.~   "
244220|NCT00357487|"~     This project consists on the realization followed by the clinical validation of two medical~     instruments dedicated to the precise sentinel lymph nodes identification and localization in~     the case of breast cancer: an intra operative probe and an operative mini gamma camera. The~     sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic~     system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy~     determination. The goal of these instruments designed by physicians and physicists is to~     significantly improve the detection efficiency of the technique in order to reduce the false~     negative rate and then the recurrence risk, as well as the operative morbidity.Clinical~     oncologist surgeons and fundamental physics applied to medical imaging researchers are~     involved in this project. The clinical validation of the medical instruments will be~     organized in the Gynaecologic and Obstetric department of the Hospices Civils de Strasbourg~     with a series of 25 patients in the framework of a regular french protocol of clinical~     research.~   "
244221|NCT00357474|"~     The purpose of this study is to choose the preferred treatment modality for multiple, small~     hepatocellular carcinomas.~   "
244222|NCT00357461|"~     RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides~     may help the body build an effective immune response to kill tumor cells. Giving ipilimumab~     together with vaccine therapy may be an effective treatment for melanoma.~      PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how~     well they work compared to ipilimumab alone in treating patients with previously treated~     stage IV melanoma.~   "
244223|NCT00357448|"~     RATIONALE: Biological therapies, such as denileukin difitox, may stimulate the immune system~     in different ways and may prevent tumor cells from growing. PURPOSE: This phase I trial is~     studying the side effects and best dose of denileukin diftitox in treating patients with~     advanced refractory ovarian cancer, primary peritoneal carcinoma, or epithelial fallopian~     tube cancer.~   "
244224|NCT00357435|"~     This study will explore the clinical and hereditary (genetic) features of corneal dystrophy~     and other inherited corneal disease. Corneal dystrophy is clouding of the cornea - the~     transparent part of the eye covering the iris and pupil that passes light to the back of the~     eye. When the cornea becomes cloudy, interfering with the passage of light, vision may be~     impaired or lost. Corneal problems may occur with vision problems alone, or with other~     problems, such as changes in facial appearance or bone or joint problems. A better~     understanding of these genetic conditions may help in the development of better diagnostic~     tests and methods of disease management.~      Patients with corneal dystrophies and related corneal disease and their family members may be~     eligible for this study. Participants will be drawn from patients enrolled in other studies~     of corneal dystrophy at the NEI and collaborating clinics.~      Participants will undergo the following tests and procedures:~        -  Medical and surgical history~        -  Verification of diagnosis~        -  Construction of a family tree regarding familial vision problems~        -  Complete eye examination, including dilation of the pupils and photography of the~          cornea, tests of color vision, field of vision, and the ability to see in the dark, and~          photographs of the eye.~        -  Blood sample collection to identify the genes responsible for corneal disease and~          ascertain how they cause disease.~   "
244225|NCT00357422|"~     The purpose of this study is to choose the preferred treatment modality for solitary, small~     hepatocellular carcinoma.~   "
244226|NCT00357409|"~     In blind individuals, the occipital cortex becomes capable of processing tactile and auditory~     information, a phenomenon described as crossmodal plasticity. GABA is the major inhibitory~     neurotransmitter in the brain and a possible candidate to mediate this form of human~     plasticity. We intend to use magnetic resonance spectroscopy (MRS) to measure GABA and~     hypothesize that GABA levels in the occipital cortex of blind humans will be lower than in~     sighted controls. Such decrease could possibly mediate compensatory changes in the occipital~     cortex of the blind.~      Objective~      Early blind subjects exhibit better tactile acuity than late blinds or sighted individuals.~     The purpose of the study is the determine GABA levels in the human occipital cortex after~     long-term light deprivation (blindness).~      Study Population~      Our experiments will make use of early blind, late blind, and sighted control subjects.~      Design~      Subject will be identified and will receive clinical and neurological examinations at the~     NIH. MRS studies will be performed at NIH MRI Center with 3Tesla Magnet. Each subject head~     will be positioned in an adjustable holder (designed for minimal motion and maximal comfort)~     such that a flat coil lay just below the occipital cortex. The sequence has been described~     before [33]. The individuals who perform the data analysis will be blind to the purpose of~     the experiments.~      Outcome measures~      The concentration of GABA from the 14 ml voxel over the visual cortex will be measured.~     Edited proton spectrum of GABA will be compared with the edited sub spectrum of creatine for~     a concentration reference.~   "
244227|NCT00357396|"~     RATIONALE: Giving chemotherapy drugs, such as busulfan, melphalan, and thiotepa, before a~     donor stem cell transplant helps stop the growth of tumor cells and prepares the patient's~     bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the~     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood~     cells, and platelets. Sometimes the transplanted cells from a donor can make an immune~     response against the body's normal tissues. Giving tacrolimus, sirolimus, and mycophenolate~     mofetil may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving busulfan together with melphalan and~     thiotepa followed by a donor stem cell transplant works in treating patients with high-risk~     Ewing's tumors.~   "
244231|NCT00357344|"~     This study will evaluate how large, intentional weight reduction affects the human brain and~     possible ways to reverse the changes associated with excess body weight. Subtle changes in~     some brain regions occur in people who are overweight. Such changes may involve the~     regulation of eating behavior, though it is not clear whether the changes were present before~     weight gain or are a consequence. Magnetic resonance imaging (MRI) will be used to study~     local structures of the brain.~      Patients ages 18 to 45 who are undergoing gastric bypass surgery and who are not pregnant or~     breastfeeding may be eligible for this study. A study group of lean participants will serve~     as controls. Patients will visit the Phoenix Indian Medical Center for about 3 days at a time~     for tests. They will have a medical examination, electrocardiogram, and tests of blood and~     urine. Questionnaires they will complete involve patients' moods and possible influence on~     eating behaviors, as well as food preferences. A taste test, smell test, and assessment of~     decision-making processes will be conducted. An oral glucose tolerance test involves a needle~     placed intravenously (IV) in the arm, for drawing blood after patients drink a sugar~     solution. The test takes about 3-1/2 hours, with six blood samples taken (about 2 tablespoons~     total). A meal test also includes use of an IV line. After patients consume a liquid meal,~     blood will be collected to analyze levels of blood sugar and hormones. For the DEXA scan,~     which measures body composition, patients will lie still while low-dose X-rays are used for 5~     to 10 minutes. Urine will be collected for 1 whole day, to measure cortisol, a hormone. The~     MRI scan uses a strong magnetic field to obtain images of body organs and tissues. Patients~     having any metal in the body that may interfere with the scanning machine should not have~     this test. For the MRI procedure, patients will lie on a table that slides into the enclosed~     tunnel of the scanner and be asked to lie still. Patients will be able to communicate with~     the MRI staff at all times during the scan, and they may ask to be removed from the machine~     at any time.~   "
244232|NCT00357331|"~     Skeletal buffering of chronic acid loads may contribute to a significant amount of bone loss~     over time. Evidence from a few small short-term studies suggests that basic compounds, namely~     potassium citrate and potassium bicarbonate may reduce bone loss and improve bone density.~      The purpose of this study is to evaluate the effects of potassium citrate on bone metabolism.~     We hypothesize that administration of potassium citrate to postmenopausal women with~     osteopenia will reduce bone resorption and improve bone mineral density.~      Postmenopausal women with osteopenia (T score between -1.0 and -2.5) and no history of~     fracture will be randomized to either daily potassium citrate or placebo for one year.~     Primary outcomes will be markers of bone turnover, which will be measured over 12 months.~     Secondary outcomes will be bone mineral density, compliance, and adverse events.~   "
244233|NCT00357318|"~     This phase I trial is studying the side effects and best dose of bevacizumab and sunitinib in~     treating patients with solid tumors. Monoclonal antibodies, such as bevacizumab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Bevacizumab and sunitinib may also stop the growth of tumor cells by blocking blood~     flow to the tumor. Giving bevacizumab together with sunitinib may kill more tumor cells.~   "
244234|NCT00357305|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with cytarabine and etoposide in treating patients with relapsed or refractory acute~     leukemia or myelodysplastic syndromes or myeloproliferative disorders. Vorinostat may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as cytarabine and etoposide, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     vorinostat together with cytarabine and etoposide may kill more cancer cells.~   "
244235|NCT00357292|"~     To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3~     concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation~   "
244236|NCT00357279|"~     The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength~     of denufosol compared to placebo in patients with mild CF lung disease.~   "
244237|NCT00357266|"~     This study will examine blood cells and other tissue samples from people with uveitis (eye~     inflammation) to try to gain a better understanding of this condition. It will look at 1) the~     differences in cells when uveitis is active and when it is under control; 2) the genes that~     control the functions of these cells during different stages of the condition; and 3) the~     proteins the cells make at these different stages.~      Patients 6 years of age or older with an eye inflammation of at least 8 weeks' duration may~     be eligible for this study. They must currently be enrolled in another NEI protocol for~     evaluation or treatment of uveitis.~      Participants will provide blood and possibly eye tissue samples as follows:~      Blood samples: Blood samples will be drawn, probably from an arm vein, during periods when~     the inflammation is bad and when it is quiet. No more than 60 mL (about 4 tablespoons) will~     be drawn at any visit, and no more than eight samples will be collected in 1 year.~      Tissue samples: For patients who require eye surgery, a sample of tissue or fluid that is~     removed as a routine part of surgery may be provided to investigators in this study for~     research purposes.~      Samples will be collected during patients' visits scheduled as part of their other protocol.~     The samples will be labeled with a special code number to preserve the patient's identity.~   "
244238|NCT00357253|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor~     cells more sensitive to radiation therapy. Giving capecitabine together with radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when~     given together with radiation therapy in treating young patients with newly diagnosed,~     nonmetastatic brain stem glioma or high-grade glioma.~   "
244239|NCT00357240|"~     The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on~     the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to~     atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.~   "
244262|NCT00356928|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of abnormal blood cells, either by killing the cells or by stopping them from~     dividing. Giving cyclophosphamide together with donor lymphocytes that have been treated in~     the laboratory may be an effective treatment for myelodysplastic syndromes or~     myeloproliferative disorders.~      PURPOSE: This clinical trial is studying the best dose of donor lymphocytes when given~     together with cyclophosphamide in treating patients with myelodysplastic syndromes or~     myeloproliferative disorders.~   "
245160|NCT00344942|"~     To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort~     versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious~     Rhinitis~   "
244240|NCT00357227|"~     B8: Atrial fibrillation and the risk of neurological complications~      Twenty-five thousand acute strokes are caused by atrial fibrillation every year. But even~     more frequent than symptomatic strokes are silent infarctions of the brain. Silent strokes~     remain undetected in most cases, but cumulate over time and progressively impair cognition.~     The impact of atrial fibrillation on subacute brain infarctions is not yet known. Moreover,~     it has not been elucidated so far how effective different therapeutic strategies in the~     treatment of atrial fibrillation prevent cognitive impairment. Thus, this study aims at~     evaluating the influence of different types of atrial fibrillation on silent strokes and the~     related impairment in cognitive functions. Other risk factors and cardiovascular diseases~     that are known to provoke the development of strokes will be assessed as well. So, it will be~     possible to isolate the contribution of atrial fibrillation to silent strokes and related~     cognitive impairment in segregation to other relevant factors. AF patients and controls will~     be examined twice in two years in order to evaluate the role of atrial fibrillation and~     differential therapeutic interventions with regard to the progression of silent strokes and~     cognitive impairment in a within subject-design.~   "
244241|NCT00357214|"~     There is increasing evidence that the acid-base balance of diet plays an important role in~     the health of bones and muscles. An excess of acid in the body can result in calcium loss and~     muscle breakdown. Potassium bicarbonate, a base supplement, can neutralize acid within the~     body. The purpose of this study is to determine the effectiveness of potassium and~     bicarbonate, alone and combined, at reducing bone loss and preventing muscle wasting in older~     adults.~   "
244242|NCT00357201|"~     To evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675,~     a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation, versus~     placebo in patients with bilateral treated moderate dry eye syndrome~   "
244243|NCT00357188|"~     The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100~     mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in~     Healthy Subjects~   "
244244|NCT00357162|"~     This phase II trial is studying how well belinostat works in treating patients with~     myelodysplastic syndromes. Belinostat may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the cancer.~   "
244245|NCT00357149|"~     To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel~     plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy~     alone in patients with locally advanced squamous cell carcinoma of the head and neck.~   "
244246|NCT00357136|"~     Researchers at Towson University are conducting a study of computer password behaviors among~     users who have difficulty using their hands and arms (e.g., individuals with carpal tunnel~     syndrome, high level spinal cord injuries, etc.). Volunteers are needed to take a short 5-10~     minute online survey.~      The survey is completely confidential and anonymous. If you would like to participate, please~     visit the URL below. Thank you.~      http://pages.towson.edu/jdarcy/securitysurvey.htm~   "
244247|NCT00357123|"~     The purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant~     drug in the integral management of abdominal sepsis acknowledged by surgery.~   "
244248|NCT00357110|"~     Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells,~     clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole~     and fulvestrant or anastrozole alone in patients with early breast cancer.~   "
244249|NCT00357097|"~     Ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms~     of Restless Legs Syndrome. Up to 40% of RLS patients suffer from mild depression, therefore~     it would be important for decisions no therapy to know whether a drug could improve both~     depressive and RLS symptoms.~   "
244250|NCT00357084|"~     RATIONALE: Methotrexate and glucocorticoid therapy, such as prednisone or methylprednisolone,~     may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell~     transplant.~      PURPOSE: This phase II trial is studying how well giving methotrexate together with~     glucocorticoids works in treating patients with newly diagnosed acute graft-versus-host~     disease after donor stem cell transplant.~   "
244251|NCT00357071|"~     This study will collect blood samples from patients with non-infectious eye inflammatory~     diseases a spectrum of eye disorders that can produce sight-threatening vision loss. The~     blood will be analyzed for substances that may provide a better understanding of the nature~     of these disorders, possibly leading to improved treatments. Treatment is not offered under~     this protocol.~      Patients 6 years of age and older with an eye inflammatory disease, including non-infectious~     uveitis, ocular cicatricial pemphigoid, non-infectious scleritis, episcleritis, Stevens~     Johnson syndrome, Moorens ulcer, peripheral ulcerative keratitis and keratoconjunctivitis~     sicca, may be eligible for this study. Patients may or may not currently be participating in~     a treatment trial.~      Participants will have blood drawn through a needle in an arm vein. More samples may be~     collected if patients enrolled in another study are scheduled for additional visits. No more~     than 4 teaspoonfuls of blood will be collected at any one time.~   "
244263|NCT00356915|"~     Onychomycosis is a common condition accounting for approximately half of all nail disorders.~     It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment~     of onychomycosis in the United States with an approved dosage regimen for the treatment of~     onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100~     mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be~     used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare~     the efficacy and safety of this new tablet formulation with itraconazole capsules and~     placebo.~   "
244326|NCT00356031|"~     The main purpose of this study is to test the effectiveness of bevacizumab in combination~     with radiation therapy to see what effects (good or bad) they have on patients with soft~     tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth~     of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by~     the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for~     patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab~     in combination with radiation for sarcomas is still under investigation.~   "
244252|NCT00357058|"~     This study will examine the role of different brain regions in tactile (touch) ability after~     application of a tourniquet (inflated blood pressure cuff). When the forearm is deprived of~     blood for a short period of time, tactile ability in the other hand improves. This study will~     try to learn what causes this improvement.~      Healthy normal volunteers are eligible for this study. Candidates will have a brief medical~     history and physical examination.~      Volunteers will undergo two experiments, described below, that involve the following~     procedures:~        -  Ischemic nerve block - A blood pressure cuff is inflated for 35-40 minutes around the~          elbow area (also around the calf for Experiment 2 - see below). The resulting numbness,~          tingling, loss of muscle strength, and discoloration of the forearm and hand disappear~          within minutes after the cuff is deflated.~        -  Magnetic resonance imaging (MRI) - This test uses a magnetic field and radio waves~          instead of X-rays to produce images of brain structure and function. The volunteer lies~          on a stretcher that is moved into the scanner (a cylinder containing a strong magnet),~          wearing earplugs to protect the ears from loud thumping noises that occur with~          electrical switching of radio frequency circuits. The subject can communicate with an~          investigator by intercom at all times during the scan.~        -  Transcranial magnetic stimulation (TMS) - An insulated wire coil is placed on the~          patient's scalp. A brief electrical current passes through the coil, creating a magnetic~          pulse that travels through the scalp and skull and causes small electrical currents in~          the outer part of the brain. The stimulation may cause muscle hand or arm twitching or~          transient tingling in the forearm, head or face muscles.~        -  Tactile spatial acuity testing - The subject's left arm is placed in a cast and the left~          index finger is immobilized for this test which involves identifying the direction of~          grooves applied to the finger.~      Experiment 1~      This experiment measures changes in tactile acuity and brain activation following cuff~     inflation. The subject lies in the MRI scanner, with the left arm immobilized. Tactile acuity~     is measured repetitively at the left index finger during placement and inflation of a~     pressure cuff around the right forearm. The experiment consists of two sessions with the cuff~     around the forearm and one with the cuff around the calf and lasts from 90 minutes to 2~     hours.~      Experiment 2~      This experiment measures changes in tactile acuity linked to TMS stimulation. The subject~     sits in an armchair with the left arm immobilized. Tactile acuity is measured repetitively at~     the left index finger during placement and inflation of a pressure cuff around the right~     forearm. In addition, TMS pulses (about one pulse per second) are delivered at different~     locations over the right side of the head for up to 30 minutes. The experiment consists of 10~     separate sessions on different days, each lasting about 1 hour.~   "
244253|NCT00357045|"~     Objectives:~        1. To determine whether paroxetine can prevent major depression in patients with hepatitis~          C (HCV) who are receiving pegylated-interferon (Peg-IFN).~        2. To determine whether paroxetine can prevent subsyndromal increases in depression and~          anxiety in patients with HCV who are receiving Peg-IFN.~        3. To determine whether paroxetine can prevent a significant change in the health related~          quality of life in patients with HCV who are receiving Peg-IFN.~        4. To determine whether paroxetine improves compliance with Peg-IFN therapy for HCV.~        5. To determine whether paroxetine enables patients to complete Peg-IFN therapy for HCV who~          might otherwise require a dose reduction or discontinuation because of neuropsychiatric~          side effects.~   "
244254|NCT00357032|"~     This phase II trial is studying how well PXD101 works in treating patients with relapsed or~     refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid~     leukemia. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the cancer.~   "
244255|NCT00357019|"~     To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in~     vernal keratoconjunctivitis~   "
244256|NCT00357006|"~     OBJECTIVE:~      To test the use of adjunctive estrogen in a 8 week, three-arm, double-blind,~     placebo-controlled study in the treatment of psychotic symptoms in women with schizophrenia.~      HYPOTHESIS:~      That women receiving adjunctive estrogen will demonstrate significantly greater improvements~     in the symptoms of schizophrenia than women receiving adjunctive placebo.~      STUDY POPULATION:~      180 women will be recruited over a three-year period across three sites. Participant will be~     of potential child-bearing age (Pre-menopausal and Post-menarche) with a current diagnosis of~     Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic~     phase)according to the Mini International Neuropsychiatric Interview (MINI).~      STUDY MEDICATION:~      Estradiol. One third of the participants (n=60) will be randomised to receive adjunctive~     100mcg Estradiol; one third of the participants (n=60) will be randomised to receive~     adjunctive 200mcg Estradiol n=60; and, one third of the participants (n=60) will be~     randomised to receive adjunctive placebo n=60). All patches will be covered with identical~     adhesive contact to ensure the blind is maintained.~      STUDY EVALUATIONS:~      Data will be collected over a two-month period for each participant. Visits will be performed~     at baseline, and then at weekly or fortnightly intervals. A total of six visits will be~     completed for each participant. The following evaluations will be performed:~      i) Inclusion/exclusion checklist. (Baseline visit only)~      ii) Informed consent. (Baseline visit only)~      iii)psychiatric evaluation to determine diagnosis. (Baseline visit only)~      iv) General clinical evaluation including medical history, current conditions and a~     non-invasive physical examination, body weight, vital signs. (Baseline and endpoint visits)~      v) Medication history. (Baseline and evaluation visits)~      vi) Demographics. (Baseline visits only)~      vii) The primary outcome measures will be the Positive and Negative Syndrome Scale (PANSS),~     which will be taken at weeks 1, 2, 4 and 8 of the trial. Cognitive testing will take place at~     baseline and 8 weeks. Side effects will be assessed at weeks 1, 2, 4, 6, and 8 to measure~     changes in subject's reported side effects during the trial.~      viii) Laboratory tests including; Serum levels of mood stabiliser, LH, FSH, Estrogen,~     Progesterone, Prolactin, DHEA,Testosterone and(Baseline and evaluation visits).~   "
244257|NCT00356993|"~     20% of Ontarians smoke. There was a decline in smoking prevalence from 1995 but it has~     remained unchanged since 2002. This rate of smoking cessation has not kept up with the rest~     of Canada. A new strategy is necessary to increase the number of smokers making quit attempts~     and to increase the odds of quitting long term.The goal of this study is to evaluate the~     methods and effectiveness of providing nicotine replacement (NRT) to Ontario smokers. The~     study will develop an evidence-based protocol for providing NRT, provide faculty development~     on combining pharmacotherapy with behavioural interventions and will provide an evaluation~     framework to inform future coverage models.~   "
244258|NCT00356980|"~     RATIONALE: Biological therapies, such as TNF-bound colloidal gold, may stimulate the immune~     system in different ways and stop tumor cells from growing.~      PURPOSE: This phase I trial is studying the side effects and best dose of TNF-bound colloidal~     gold in treating patients with advanced solid tumors.~   "
244259|NCT00356967|"~     The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking~     cessation in cigarette smokers. The main secondary objectives are: to assess the craving for~     cigarettes, nicotine withdrawal symptoms and the safety of dianicline.~   "
244260|NCT00356954|"~     The contrast induced nephropathy (CIN) has been known to be associated with significant~     clinical and economic consequences. Many studies were performed to find the pathophysiology~     and preventive measures for CIN. But the results were somewhat frustrating. Recently, it has~     been reported that the N-acetylcysteine and ascorbic acid might have preventive effects for~     CIN by their antioxidant effects.There have been no study to compare these two antioxidant.~   "
244261|NCT00356941|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin and~     docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and~     docetaxel together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when~     given together with docetaxel and radiation therapy in treating patients with unresectable~     stage II or stage III or recurrent non-small cell lung cancer .~   "
244820|NCT00349440|"~     The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic~     solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients~     undergoing LASIK or photorefractive keratectomy (PRK).~   "
244264|NCT00356902|"~     Preterm infants are born with immature lungs and often require help with breathing shortly~     after birth. This currently involves administering 100% oxygen. Unfortunately, delivery of~     high oxygen concentrations leads to the production of free radicals that can injure many~     organ systems. Term and near-term newborns deprived of oxygen during or prior to birth~     respond as well or better to resuscitation with room air (21% oxygen) compared to 100%~     oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm~     infants with lung disease. Our study will investigate how adjusting the amount of oxygen~     given to sick preterm newborns will affect the ability to maintain a safe oxygen level in~     their blood. Each infant will be assigned to receive one of three treatments at birth.~     Resuscitation will either start with 21% oxygen and be increased if needed, 100% oxygen and~     be decreased if needed or 100% oxygen with no changes made (current standard of treatment).~     The first two groups will have adjustments in oxygen concentration as needed to reach a safe~     target range of blood oxygen saturation. We anticipate that preterm newborn infants~     resuscitated with higher oxygen concentrations will have higher than normal levels of~     oxygen in their blood while those resuscitated initially with lower concentrations of oxygen~     will be more likely to have normal oxygen levels in their blood. All premature infants will~     have a surface probe placed on the right hand to measure the saturation of blood with oxygen.~     Following the resuscitation, treatment will proceed as per standard of care until hospital~     discharge. All infants will be admitted to the neonatal intensive care unit given their~     prematurity. The purpose of this study is to investigate how safely restricting the amount of~     oxygen delivered to newborns during resuscitation will affect the amount of oxygen in their~     blood.~      Hypothesis: In this randomized control trial, infants resuscitated with a low oxygen~     delivery (LOD) strategy (initiation of resuscitation with 21% O2) will remain normoxemic for~     the greatest proportion of time during resuscitation and infants resuscitated with a high~     oxygen delivery (HOD) strategy (100% O2 used for the entire resuscitation) will be~     normoxemic for the smallest proportion of time during resuscitation.~   "
244265|NCT00356889|"~     This phase II trial is studying how well giving bevacizumab together with erlotinib~     hydrochloride works in treating patients with metastatic or unresectable biliary tumors.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Erlotinib hydrochloride may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and~     erlotinib hydrochloride may also stop the growth of tumor cells by blocking blood flow to the~     tumor. Giving bevacizumab together with erlotinib hydrochloride may kill more tumor cells.~   "
244266|NCT00356863|"~     The main aim of the study is to determine the effectiveness of an educational intervention~     designed to increase attendance of coronary artery bypass grafting (CABG) patients at Cardiac~     Rehabilitation Programs (CRPs) on actual CRP participation rate and; examine patient-related~     factors (demographic, health, psychosocial, awareness) influencing patients' attendance at~     CRPs. We hypothesized that the proportion of CABG patients participating in CRPs will~     increase significantly to 20-30% following the educational intervention employed.~   "
244267|NCT00356850|"~     To evaluate azithromycin tear concentrations after instillation of one drop of one of the~     three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.~   "
244268|NCT00356837|"~     The purpose of this study is to determine the efficacy of ultrasound in diagnosing the~     presence or absence of extremity fractures or dislocations.~      Hypothesis: Can ultrasound be used as an accurate and effective method for determining the~     presence or absence of extremity fractures or dislocations? Is there a difference in amount~     of pain experienced prior to and after the ultrasound?~   "
244269|NCT00356824|"~     HIV and malaria are two of the most important diseases to afflict children in sub-Saharan~     Africa. However, it is unknown what relationships exist between the two diseases. The purpose~     of this study is to determine the relationship between HIV and malaria infections in HIV~     infected Ugandan children.~   "
244270|NCT00356811|"~     This study investigates the safety and efficacy of oral lapatinib in combination with an~     approved medication, paclitaxel, for patients with ErbB2 metastatic breast cancer.~   "
244271|NCT00356798|"~     Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical~     trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole~     virion H5N1 vaccine with aluminium hydroxide adjuvant.~   "
244272|NCT00356785|"~     Eligible overweight and obese persons will be randomized to one of three controlled groups: 1~     group of participants is treated by health education for life style intervention only. The~     other 2 groups will be included in a dietary program with an individually dosed food~     supplement (Almased®) for an initial weight reduction for a period of 6 weeks. The following~     18 weeks represent the most important phase of weight loss and attitude, the participants~     take part in 2 different interventions according to their randomization. One group will~     continue the dietary program, one group will try to achieve and maintain weight reduction by~     continuing the initial dietary program together with an additional physical activity program.~     For all intervention groups the following 6 months aim at a further stabilization of weight~     and attitude, now without defined guidelines of intervention but with the intention to~     continue the so far practiced change in life style. All participants will be supplied with~     adequate information and material concerning the desired change in life style.~   "
244273|NCT00356772|"~     To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment~     initiation.~      To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7~   "
244274|NCT00356759|"~     Patients with mechanical heart valve prosthesis or with irregular beat (atrial fibrillation)~     have a high risk of blood clot formation. Such clots can result in a stroke. The patients are~     treated with warfarin - a blood thinner - to prevent these complications. The treatment has~     to be monitored with a blood test called Prothrombin time (PT) every 1-4 weeks. The dose of~     warfarin has to be changed whenever the PT result is outside of the treatment range. If the~     result is too low there is an increased risk of blood clots. If, instead, the result is too~     high there is a risk of bleeding. One third of the patients have very stable PT results and~     hardly ever have to change the dose.~      The investigators hypothesis is that these patients can go less often, e.g. every 12 weeks,~     for the blood tests.~   "
244275|NCT00356746|"~     The purpose of this study is to investigate the effects of total intravenous anesthesia~     versus volatile anesthesia on the perioperative inflammatory response during and after major~     surgery.~   "
244320|NCT00356109|"~     A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin~     Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable~     insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with~     type 1 diabetes mellitus.~      This study is designed also to examine insulin antibody levels in AIR Insulin -treated~     patients compared with injectable insulin-treated patients with type 1 diabetes.~      The present study is intended to determine if preprandial AIR Insulin is non-inferior to~     preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from~     baseline to endpoint at 6 months in patients with type 1 diabetes.~   "
244276|NCT00356733|"~     Erythropoietin (EPO) treatment in patients with the severe cardiorenal syndrome increases~     cardiac performance and decreases progression of renal failure by dampening the main driving~     forces of the cardiorenal syndrome in part via non-erythropoietic pathways.~      I. Does EPO administration to patients with the severe cardiorenal syndrome increase cardiac~     performance and decrease progression of renal disease?~      II. Does EPO treatment affect the main driving forces of the cardiorenal connection, that is,~     dampen the activated renin-angiotensin system (RAS), attenuate increased reactive oxygen~     species (ROS), normalize increased sympathetic activity, and decrease inflammation?~      III. Does EPO treatment positively affect the cell function of patients with the cardiorenal~     syndrome:~        1. are gene expression signatures of leukocytes positively influenced by EPO treatment,~        2. does EPO shift the Jak/STAT pathway to a less pro-inflammatory profile in monocytes, and~        3. are function and number of endothelial progenitor cells (EPCs) affected by treatment~          with EPO in the cardiorenal syndrome?~      IV. Can the direct actions of EPO be differentiated from the effects on hemoglobin levels?~   "
244277|NCT00356720|"~     To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops,~     in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg/kg, for the~     treatment of active trachoma. Evaluation of clinical efficacy was primary (% of clinical cure~     at Day 60 in Per Protocol Set), microbiological evaluation was secondary~   "
244278|NCT00356707|"~     African American women have higher rates of obesity than women of any other racial or ethnic~     group in the United States. Obesity can have many causes, including genetic and environmental~     factors. This study will examine how neighborhood environments influence the occurrence of~     obesity among African American women.~   "
244279|NCT00356681|"~     To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706~     placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to~     estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus~     bevacizumab.~   "
244280|NCT00356668|"~     The specific aims of this study are to evaluate the amount of high flow nasal cannula (HFNC)~     gas flow required to generate an equivalent positive distending pressure as that provided by~     nasal continuous positive airway pressure (NCPAP) of 6 cm H2O, assess the relationships~     between positive distending pressure, gas flow, oxygen requirement, and patient weight, and~     lastly, develop an appropriate protocol to be used in the NICU for transitioning patients~     from NCPAP to an equivalent amount of HFNC.~   "
244281|NCT00356655|"~     This a comparative study of enhanced pharmacist care and regular care of patients starting on~     antidepressants. When providing participants with enhanced care pharmacists will use the~     Health Professional's Antidepressant Communications Tool (Health PACT) a minimum of three~     times during face-to-face discussions. This tool was developed specifically for this study.~     All participants will be followed for 26 weeks and will be assessed for duration of use of~     their antidepressant, adherence to treatment, and clinical response.~   "
244282|NCT00356642|"~     The purpose of this study of this study is to investigate the safety, tolerability and~     pharmacokinetics of GW842470X in patients with atopic dermatitis. GW842470X is an inhibitor~     of phosphodiesterase 4 (PDE4).~   "
244283|NCT00356629|"~     The aim of the study is identify biological parameters reflecting proteolytic activity in the~     exhaled condenstaes which might be useful to follow up pulmonary inflammation in various~     conditions including cystic fibrosis, COPD, asthma, tobacco exposure. Three proteases will be~     analyzed, i.e. elastase, proteinase 3 and cathepsin G. Results in the condensates will be~     compared to those obtained in sputum.~   "
244284|NCT00356616|"~     To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir +~     TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral~     treatment that present virological failure and multiple resistance to antiretrovirals.~   "
244285|NCT00356603|"~     This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg~     kit product for the treatment of migraine or cluster headache attacks in clinical settings,~     to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness)~     and rate of successful self-injection.~   "
244286|NCT00356590|"~     This is an open label, multicenter study for extended treatment of patients who have~     participated in the Immunex clinical study 016.0012. The primary objective of this study is~     to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage~     rheumatoid arthritis.~   "
244287|NCT00356564|"~     Persistence of seroprotective antibody concentrations & immunological memory shown by the~     ability to mount a response to a challenge dose of HBV vaccine~   "
244288|NCT00356551|"~     The goals of this study are to evaluate the effects of an in-home parenting education~     program, called Family Spirit, on parenting knowledge and skills and decreasing alcohol and~     substance use compared to a breast-feeding education. In addition, we will assess aspects of~     mother/child interaction.~   "
244289|NCT00356525|"~     The purpose of this study is to help answer:~        -  Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s)~          disappear in patients with relapsed lung cancer (lung cancer that has come back after~          surgical removal and chemotherapy), and to determine how long this will last~        -  Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung~          cancer live longer~   "
244321|NCT00356096|"~     The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to~     0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and~     depressive symptoms, after 12 weeks of treatment~   "
244322|NCT00356083|"~     Patients with non-malignant pain are switched from morphine to methadone with a nine-months'~     follow-up.~   "
244323|NCT00356070|"~     The treatment of ADHD in jail will help the prisoners in their rehabilitation process~   "
244324|NCT00356057|"~     The purpose of this study is to demonstrate the safety and effectiveness of biventricular~     pacing over conventional right ventricular pacing in patients with persistent or permanent,~     symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent~     pacing therapy.~   "
244325|NCT00356044|"~     The aim of this study is to compare the radial and femoral access for percutaneous~     interventions in the acute phase of the ST elevation acute myocardial infarction in terms of~     efficacy and security.~   "
244290|NCT00356512|"~     This study will explore the regulation of fibroblast growth factor-23 (FGF-23). It is a~     hormone recently identified as a regulator of the blood levels of phosphorus and vitamin D,~     both of which are essential for overall health and especially important for bone health. The~     parathyroid hormone (PTH) regulates phosphorus and calcium, but people with~     hypoparathyroidism or pseudohypoparathyroidism do not have sufficient PTH action. There are~     genetic diseases that influence FGF-23, causing abnormal metabolism of phosphorus and vitamin~     D, thus affecting the bones. Also, there are rare tumors that may cause overproduction of~     FGF-23 causing debilitating bone disease.~      Patients ages 18 and older who have low PTH levels, or are resistant to PTH action, and take~     calcitriol and calcium supplements, who are not pregnant, and who do not have kidney~     disorders may be eligible for this study. During the 4-day study, patients will be provided~     with a controlled diet that has a lower than usual phosphorus content. On day 1, patients~     will be admitted to the NIH Clinic Center and undergo blood and urine tests to measure~     calcium, phosphorus, vitamin D, and FGF-23. They will continue with their regular medicine~     for hypoparathyroidism. On that day and throughout the study, patients will fast from 10:00~     p.m. to 8:00 a.m. the following day. On day 2, patients will continue fasting until 4:00 p.m.~     A tube will be placed in the vein of each arm: one for drawing blood and the other for~     infusing calcium. Just one intravenous (IV) line will be used on the other days. Patients~     will receive calcium chloride for 8 hours, at a dose carefully monitored by a machine. The~     purpose is to bring the blood calcium level to the high normal range or just above. Blood and~     urine samples will be collected periodically, to check for effects of calcium chloride on~     FGF-23 and PTH. On days 3 and 4, patients will not take calcitriol and calcium but will~     receive injections of PTH, under the skin, two times each day. On day 3, blood and urine~     samples will be again be collected for analysis. On day 4, patients will receive one dose of~     calcitriol by IV. The total amount of blood drawn during this study will be about 5 ounces.~   "
244291|NCT00356486|"~     The purpose of this study is to compare the early virological response (EVR = undetectable~     [ribonucleic acid-hepatitis C virus] RNA-HCV or a reduction of > 2 log10) of patients with~     chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon~     alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of~     treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day~     versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200~     mg/day for 12 weeks.~   "
244292|NCT00356473|"~     This research evaluates the effects of a cholesterol-lowering medication, atorvastatin, on~     both arthritis activity and the ability of high-density lipoprotein cholesterol (HDL-C,~     sometimes referred to as good cholesterol) to prevent changes in low-density lipoprotein~     cholesterol (LDL-C, sometimes referred to as bad cholesterol), which lead to~     atherosclerosis, or hardening of the arteries. We hypothesize that atorvastatin may improve~     both joint inflammation and the anti-inflammatory properties of HDL cholesterol.~   "
244293|NCT00356460|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of GC1008, a human anti-transforming growth factor-beta (TGFβ) monoclonal~     antibody in previously treated patients with locally advanced or metastatic renal cell~     carcinoma or malignant melanoma.~   "
244294|NCT00356447|"~     The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and~     estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor~     symptoms) and uro-genital complaints.~   "
244295|NCT00356434|"~     The researchers at Johns Hopkins University believe that the foot pump will be superior to~     sequential compression devices in comfort and patient compliance which may increase provider~     efforts to prevent deep vein thrombosis (DVT) in pregnancy.~   "
244296|NCT00356421|"~     To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes~     mellitus~   "
244297|NCT00356408|"~     This is an open-label extension study designed to measure the safety, efficacy, and~     corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to~     severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).~   "
244298|NCT00356395|"~     we hypothesized that combination therapy has additive beneficial effects to improve~     endothelial dysfunction and adipocytokine profiles in patients with hypertension.~   "
244299|NCT00356382|"~     The purpose of this study is to determine the effectiveness of a cultured dairy drink with~     high concentrations of active L casei to reduce the cumulative rate of illness in~     daycare/school children ages 3 to 6.~   "
244300|NCT00356369|"~     Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y.~     Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell~     dependant immune response while the existing polysaccharide vaccines induce a T-cell~     independent response, i.e. with no immune memory response. GSK Biologicals has developed a~     combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to~     serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT~     conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as~     control. In the long-term follow-up phase (extension phase) of the study, the long-term~     protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years~     after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This~     protocol posting deals with objectives & outcome measures of both the primary & extension~     phases.~   "
244301|NCT00356356|"~     The purpose of this study was to evaluate extended safety and efficacy of etanercept in~     adults with Ankylosing Spondylitis.~   "
244302|NCT00356343|"~     The purpose of this study is to determine if using high-intensity, short-duration,~     intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise~     in increasing quadriceps femoris and triceps surae force-generating potential and gross motor~     function in children with cerebral palsy.~   "
244303|NCT00356330|"~     To evaluate short-term and long-term effects by MR imaging at 3T on the technical and~     functional status of cardiac pacemakers.~   "
244304|NCT00356317|"~     This study will evaluate the effectiveness of a culturally based family therapy intervention~     in improving treatment outcome in people with schizophrenia.~   "
244305|NCT00356304|"~     This study will determine the effectiveness of motivational interviewing in improving~     antidepressant medication adherence among Hispanics.~   "
244306|NCT00356291|"~     This study will evaluate the effectiveness of motivational interviewing plus skill building~     in reducing HIV risk behavior in people with serious mental illnesses.~   "
244307|NCT00356278|"~     This study will determine whether a combination of virtual reality exposure therapy and~     D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.~   "
244327|NCT00356018|"~     To determine, in a randomized, parallel open-label fashion, compliance rates between~     once-daily extended-release divalproex sodium tablets (Depakote-ER®, Abbott Labs) versus~     multiple-daily dose valproic acid capsules (Depakene®, Abbott Labs) in an epilepsy~     population.~   "
244308|NCT00356265|"~     The purpose of this study is to learn more about why most patients with early stages of~     kidney disease have high blood pressure.~      We know the body produces natural substances that cause blood vessels to open wider to carry~     more blood when needed. An example is during exercise. Other natural substances cause blood~     vessels to get smaller and slow down blood flow when needed. An example is when people are~     cold. The balance between these substances is important. People with kidney disease and high~     blood pressure do not have the normal balance of these substances.~      This study will include 3 groups of people, people with normal blood pressure, people with~     high blood pressure and people with kidney disease.~        -  Subjects will have a screening physical examination, including an ECG and laboratory~          tests~        -  Subjects with high blood pressure may not take their regular blood pressure medication~          for 3 weeks prior to the inpatient GCRC study~        -  Subjects will be given intra-arterial medications that will cause changes in the blood~          vessels during the in-patient study.~      The study will then compare the responses of the three groups. A GFR test will be done to~     confirm the renal function of the group with chronic kidney disease.~      These studies will provide insight into the mechanisms of the pathogenesis of enhanced α1~     vasoreactivity in subjects with progressive renal disease. This will lay the groundwork for~     new strategies in the treatment and prevention of vascular disease among the rapidly growing~     group of individuals with CKD.~   "
244309|NCT00356252|"~     This study will examine the the efficiency fo absorption of major plant pigments,~     carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of~     carotenoids in healthy women in response to an 8-week period of carotenoid supplementation.~      The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single~     cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor~     Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA~     microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and~     antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the~     circulation will be measured every other week throughout the study period.~   "
244310|NCT00356239|"~     To evaluate short-term and long-term effects by MR imaging on the technical and functional~     status of implantable cardioverter defibrillators.~   "
244311|NCT00356226|"~     To examine the effects of the addition of clonidine to diuretics on the mobilization of~     ascites at short-term (diuretic response and requirement of diuretics) and long-term~     (readmissions for tense ascites and requirement of diuretics) in cirrhotics with increased~     sympathetic nervous system. Secondary objectives were to study neuro-hormonal,hemodynamic~     effects and side effects of clonidine and diuretics.~   "
244312|NCT00356213|"~     The laparoscopic sleeve-gastrectomy (SG) compared to laparoscopic proximal Roux-Y-gastric~     bypass (PGB) is as successful in the treatment of morbid obesity in the majority of patients.~     In case of insufficient weight loss malabsorption can to be added by performing laparoscopic~     bilious-pancreatic diversion duodenal switch (BPD). The resection of the gastric fundus (LG)~     leads to changes in gastrointestinal hormones that are possibly different to bypassing the~     fundus (PGB).~   "
244313|NCT00356200|"~     We are doing this research study to evaluate the effectiveness and safety of fluphenazine~     decanoate when injected with a needle into psoriasis lesions in adults. Fluphenazine~     decanoate is FDA (U.S. Food and Drug Administration) approved for use in people who have~     schizophrenia and psychotic symptoms. Fluphenazine decanoate is not approved by the FDA for~     use in psoriasis. Fluphenazine decanoate slows T cell growth in cells in laboratory test~     tubes. Its usefulness and safety in people with psoriasis will be investigated in this study.~   "
244314|NCT00356187|"~     Critically injured patients endure a period of hypermetabolism/catabolism after being~     resuscitated. The metabolic cost of this may be measured in loss of lean body mass, poor~     wound healing, susceptibility to infection and long hospital stays. While there have been~     some data to suggest that hypermetabolism can be ameliorated in burn patients by beta~     blockade, to our knowledge, a prospective trial in trauma patients has not yet been done. Our~     hypothesis is that nonselective beta blockade will reduce catabolism, improve glucose~     control, blunt loss of lean body mass, decrease infections and improve outcome in a cohort of~     critically injured patients.~   "
244315|NCT00356174|"~     The purpose of this study is to observe the natural course of food allergy, including both~     the development of peanut allergy in infants at high risk for developing this allergy, and~     the resolution of both egg and cow's milk allergy.~   "
244316|NCT00356161|"~     Procedures to provide interventional implantation of a port catheter system into the hepatic~     artery and adjacent regional chemotherapy of the liver are optimized in the scope of an open,~     single-arm trial in patients with metastases and cancers confined to the liver. The primary~     objective is the improvement of indication, implantation procedure, and regional~     chemotherapy. Secondary objectives are port patency, comparison of complications with a~     historical collective of patients provided with a surgical hepatic arterial port device~     (colorectal cancer patients only), progression free and overall survival, efficacy of~     maintaining regional chemotherapy with 5-FU in combination with systemic treatment in~     patients with extrahepatic progression, quality of life.~   "
244317|NCT00356148|"~     This is a single center trial to compare the rate of surgical site infection (SSI) in normal~     (BMI equal to or less than 25; Control Group)) and overweight (BMI over 25) women who are~     undergoing breast cancer surgery. The overweight patients are further randomized into two~     groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam;~     Prophylaxis Group), in the other they do not (No Prophylaxis Group).~   "
244318|NCT00356135|"~     This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel~     75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of~     study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous~     coronary intervention (PCI) with placement of a stent, performed to treat acute coronary~     syndrome (ACS).~   "
244319|NCT00356122|"~     The purpose of this study was to see how well three investigational drugs worked together in~     preventing progression of the disease. This study provided a new combination of chemotherapy~     drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer.~     The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor~     and may also prevent tumor growth. The three investigational drugs are United States Food and~     Drug Administration (FDA) approved.~   "
244332|NCT00355953|"~     The present research program is proposed deepening some pharmacological effects of the~     genistein therapy in order to individualize alternative treatments to the conventional~     hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and~     the osteoporotic consequences in postmenopausal women.~   "
244333|NCT00355940|"~     The investigators want to test a navigation system for guidance during insertion of stent~     graft in abdominal aortic aneurysms. The navigation system consists of software developed by~     SINTEF Health, a custom made catheter with a micro position sensor in the tip and an emitter~     than induces an electromagnetic field around the patient. Preoperative CT- and intraoperative~     DynaCT- data are reconstructed into 3 dimensional images. The 3 dimensional images are loaded~     into the navigation system. Then the magnetic field, in which the patient finds himself, is~     calibrated with the 3 dimensional images. When the catheter is inserted into the iliac artery~     and aorta, the position sensor (in the tip of the catheter) is displayed in real time at the~     exact anatomic location in the 3 dimensional image.~      Null hypothesis (H0):~        -  Insertion of stent graft is performed equally satisfactorily with fluoroscopy alone as~          with both fluoroscopy and new navigation technology~      Alternative hypothesis (H2):~        -  Insertion of stent graft is NOT performed equally satisfactorily with fluoroscopy alone~          as with both fluoroscopy and new navigation technology~   "
244334|NCT00355927|"~     The purpose of this study is to detect possible changes in the electrical activity of the~     Basal Ganglia related to sedation during deep brain stimulation surgery.~   "
244335|NCT00355914|"~     1. To demonstrate whether:~           i. Facet joint nerve blocks have therapeutic value beyond the duration of local~          anesthetic effect.~           ii. Adjuvant medications (Sarapin and Depo-steroids) provide additional relief of lumbar~          facet joint pain when used with facet joint nerve blocks.~        2. To demonstrate whether or not there are clinically significant improvements in function~          of patients who receive lumbar facet joint nerve block with or without Sarapin and~          Depo-steroids (Group II) compared to patients randomized to Group I who receive only~          local anesthetic blocks.~        3. To determine the adverse event profile in both groups.~   "
244336|NCT00355901|"~     To assess the effects of visilizumab on the safety of subsequent salvage therapies in~     subjects who experienced disease progression in a previous visilizumab study and subsequently~     received salvage therapy.~   "
244337|NCT00355888|"~     The purpose of this study is to determine whether MBP-426 (liposomal oxaliplatin suspension~     for injection) is safe and effective in the treatment of advanced or metastatic solid tumors.~   "
244338|NCT00355875|"~     Hypothesis: In this feasibility study, hyperoxemia, as approximated by transcutaneous~     hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary~     oxidative stress as demonstrated by elevation of pulmonary protein carbonyl. Furthermore,~     this oxidative stress will be directly proportional to the imposed oxygen-burden during~     resuscitation at the time of birth.~      This study will give us information regarding the magnitude of protein carbonyl elevation in~     the preterm infant. With these results we will be able to 1. establish the technique for the~     running or protein carbonyl assays and 2. calculate an appropriate sample size for a future~     randomized control trial.~   "
244339|NCT00355862|"~     The purpose of this study is to determine the safety and efficacy of sirolimus-based~     immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for~     hepatocellular carcinoma (HCC), with regard to HCC recurrence-free patient survival.~   "
244340|NCT00355849|"~     A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder [also known as~     AIR® Inhaled Insulin][AIR® is a registered trademark of Alkermes,Inc.] in patients with Type~     2 diabetes who are currently being treated with once daily insulin glargine injections. The~     present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily~     insulin glargine injections.~   "
244341|NCT00355836|"~     The purpose of this study is to assess the therapeutic benefits of motor imagery training in~     stroke patients with persistent motor weakness.~   "
244342|NCT00355823|"~     The investigators have developed a new non-invasive medical device called the Bioelectric~     Field Imager. They plan to use this device to measure the electric field near small lancet~     wounds in 60 volunteers. Their hypothesis is that the electric field is an early stimulus for~     wound healing and the magnitude of this field will vary with wound healing capability. The~     investigators will compare the electric fields near arm and leg wounds in males and females~     in the age groups of 18-30 and 65-80. In addition they will measure these wound fields in~     diabetics and near chronic ulcers.~   "
244343|NCT00355810|"~     This randomised, double blind, cross-over study compares the effect (symptoms, fecal~     bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF~     1298 with placebo in patients with irritable bowel syndrome. The results are related to~     dietary habits, food intolerance and food allergy.~   "
244344|NCT00355797|"~     This is a randomized, prospective, single-blinded, multi-center study involving approximately~     1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness~     of Closed Loop Stimulation (CLS) rate adaption technology over both standard rate responsive~     technology (R) and non-rate responsive mode (DDD) during activities of daily living (ADL).~   "
244373|NCT00355420|"~     Femur fractures are a common injury in the Pediatric population. Despite their high incidence~     little do we know about the long term implications on the bones' length. Our main goal is to~     clarify this obscure issue by assessing the femoral and tibial length as determined by the~     fractures, measuring techniques and treatment modalities~   "
244374|NCT00355407|"~     The purpose of this study is to find out if Darbepoetin alfa is effective in treating low red~     blood cell levels after allogeneic stem cell transplant. Darbepoetin alfa has been shown to~     help raise red blood cell levels without blood transfusions.~   "
244375|NCT00355394|"~     Migraine is common in children and is one of the most common etiologies of headache leading~     to emergency room presentation in children. Despite this, few studies have investigated the~     treatment of acute migraine headache in the emergency room. We will perform a prospective,~     double-blind, placebo-controlled study of metoclopramide versus placebo in the treatment of~     acute migraine headache. The primary outcome will be the number of subjects headache free at~     two hours.~   "
244345|NCT00355784|"~     With the alarming increase in the prevalence of obesity, identifying factors that predispose~     individuals to weight-gain is of critical importance. Even when caloric intake and physical~     activity levels are well controlled, susceptibility for weight-gain is heterogeneous. Basal~     metabolic rate (BMR) represents the largest portion of daily energy expenditure in normal~     adults, and as such, variability in BMR among individuals can be a major factor in~     determining the susceptibility for gaining weight. However, factors responsible for this~     variability in BMR and resistance to weight-gain remain unclear. Our preliminary data~     indicate that high-normal growth hormone (GH) concentration is associated with resistance to~     weight-gain in rats when overfed and greater weight-loss in humans when underfed. In~     addition, the investigators have found that the pulsatility of GH secretion has profound~     effects on several metabolic processes. Therefore, together these findings suggest that~     endogenous GH secretion is associated with body weight regulation, and the pulsatility (peak~     amplitude) of GH secretion, rather than the absolute GH concentration, per se, may be~     responsible for this effect. Because GH influences many of the key metabolic processes that~     contribute to BMR (e.g.; protein synthesis, proteolysis, substrate cycling), the~     investigators anticipate that the resistance to weight-gain in persons with elevated GH~     concentrations will be associated with an increase in BMR due to acceleration of some or all~     of these processes. Our overall hypothesis is that increased GH secretion can protect against~     weight-gain due to an augmentation of major metabolic processes that contribute to BMR.~     Identifying factors responsible for predisposing individuals to weight-gain will lead to~     establishing improved methods for reducing the prevalence of obesity.~   "
244346|NCT00355771|"~     The purpose of this study is to investigate, whether levocetirizine 5 mg relieves nasal and~     ocular symptoms of persistent allergic rhinitis and reduces increased airway resistance and~     sleep impairment due to this condition.~   "
244347|NCT00355758|"~     : Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption~     Ionization) analysis can predict biopsy results better than PSA tests.~   "
244348|NCT00355745|"~     In the United States, breast cancer is the most common cancer occurring in women (excluding~     cancers of the skin) and the second most common cause of death from cancer in women (after~     lung cancer). Approximately 182,800 new cases per year occur in the United States, causing~     40,800 death cases per year. Breast cancer is the leading cause of death in women aged 44-50~     years. The 5-year survival rate is 60% overall but is greater than 80% for early disease.~      If diagnosed at an early stage, breast cancer has an encouraging cure rate: up to 97% of~     women diagnosed with localized breast cancer will survive five years after their diagnosis.~     Even if the cancer is found at a more advanced stage, new therapies have enabled many people~     with breast cancer to experience the same quality of life as before their diagnosis.~      Breast ultrasound (US) is an extremely useful modality in the diagnosis of breast disease in~     the symptomatic clinic. It is routinely used as an adjunct to x-ray mammography and clinical~     examination and, with younger patients it may be the sole imaging modality. It has~     well-established value in differentiating between malignant and benign solid lesions in some~     cases, however, it cannot replace fine needle aspiration and core biopsy.~      Conventional breast US scanning is highly operator- dependent, requiring skillful probe~     manipulation and the mental ability to envisage 3-D tissue structure. Acquiring 3-D US data~     sets may be advantageous, making it easier to see and interpret 3-D structures, boundaries~     and interactions.~      CBUS™, Circular Breast Ultrasound Scanner is indicated to improve significantly breast images~     obtained by ultrasound systems. The CBUS™ system automatically acquires a complete breast~     image and constructs a high quality 3D image of the scanned breast. These images provide~     diagnostic information of the complete volume of breast tissue including blood flow in a~     single ultrasonic 3D image.~      In this clinical study, the CBUS™ Circular Breast Ultrasound Scanner will be used to~     automatically image the complete breast and provides a high quality 3D image of the scanned~     breast.~   "
244349|NCT00355732|"~     To evaluate and compare two methods of weaning from mechanical ventilation in patients with~     chronic obstructive pulmonary disease (COPD) where the extubation failed.~   "
244350|NCT00355719|"~     The purpose of this study is to evaluate the influence of nevirapine in exposure to~     atazanavir boosted with ritonavir, in steady state equilibrium, in HIV-infected adult~     patients.~   "
244351|NCT00355706|"~     1. To demonstrate whether:~           i. Facet joint nerve blocks have therapeutic value beyond the duration of local~          anesthetic effect.~           ii. Addition of Depo-steroid provides additional relief of thoracic facet joint pain~          when used with facet joint nerve blocks.~        2. To demonstrate whether or not there are clinically significant improvements in function~          of patients who receive thoracic facet joint nerve block with Depo-steroid compared to~          patients randomized to Group I who receive only local anesthetic blocks.~        3. To determine the adverse event profile in both groups~   "
244352|NCT00355693|"~     Whether patient-maintained sedation (the patient controls his/her degree of sedation using a~     hand-held device) using the drug propofol is safer and more effective when using~     deteriorating reaction time as an added safeguard against the potential for over sedation in~     a groups of patients undergoing oral surgery, general dentistry and colonoscopy.~   "
244353|NCT00355680|"~     To Demonstrate that indigenous green laser produces similar treatment effect on the retina~     when compared with already available green laser.~   "
244354|NCT00355667|"~     The purpose of this study is to compare therapeutic effects of furosemide, a short-acting~     loop diuretic, and azosemide, a long-acting one, in patients with heart failure, and to test~     our hypothesis that long-acting diuretics are superior to short-acting types in heart~     failure.~   "
244355|NCT00355654|"~     The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to~     allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as~     Prevenar®.~      Primary Objective:~      To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers~     at 11-18 months of age.~      Secondary Objectives:~        -  To describe the incidence rate of severe fever within four days post-vaccination~        -  To describe the antibody responses to all antigens in a subgroup of subjects at baseline~          and post-vaccination.~   "
244356|NCT00355641|"~     The primary objective of this study is to assess the safety and tolerability of ropinirole XR~     in the long-term treatment (up to 52 weeks)of adults with RLS.~   "
244357|NCT00355628|"~     This study is a Phase II open-label study to investigate the recommended conversion ratio~     (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in~     cancer patients.~   "
244358|NCT00355615|"~     The primary objective of this study is to determine the efficacy of once-daily rosuvastatin~     in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day~     0) to the end of the 12-week double-blind treatment period.~   "
244390|NCT00355199|"~     Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab~     followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk~     patients with DLBCL Non-Hodgkin's lymphomas.~   "
244359|NCT00355602|"~     Ulcerative colitis (UC) is an acute and chronic inflammatory bowel disease, whose cause is~     unknown. However, it is widely accepted that bacteria living in the large bowel are essential~     for the development of the disease. Intuitively, therefore, a logical approach to treatment~     would be to use antibiotics. However, antimicrobial chemotherapy has been unsuccessful in~     managing acute colitis, and has had only limited benefit in long-term treatment. The failure~     of antibiotics in UC arises from the fact that no-one has tried to identify which bacteria~     are involved in causing disease, and equally importantly, nobody has targeted appropriate~     antibiotics to knock out the specific bacteria in question, in a systematic way. Despite~     this, increasing evidence implicates bacteria living on the lining of the bowel being~     involved in UC. Our aim, therefore is to identify bacteria colonizing the mucosal surface in~     the lower large intestine and to determine the antibiotic sensitivities of those the~     investigators believe to be particularly involved in the disease, such as enterococcit,~     peptostreptococci and enterobacteria. Because the investigators have already studied~     resistance to antimicrobial in many mucosal isolate, the investigators plan ot focus on using~     a combination of two antibiotics in this work. A controlled trial will test the benefit of~     using these antibiotics over a period of one month and then the patients will be followed up~     over a six month period. The investigators will be looking for significant long-term~     improvements, and a reduction in drug use following antibiotic therapy.~   "
244360|NCT00355589|"~     The purpose of this study is to determine if there is greater blood pressure reduction using~     ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.~   "
244361|NCT00355576|"~     The objective of this study is to compare two combinations of drugs, minocycline and creatine~     or celecoxib and creatine, in a phase II trial designed to determine which combination is~     more effective for ALS.~   "
244362|NCT00355563|"~     The study has been designed to comparatively evaluate the safety and effectiveness of the~     PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the~     connection between graft veins and the aorta in patients undergoing coronary artery bypass~     graft surgery for treatment of coronary artery disease. Patients in the study will have a~     coronary angiogram approximately 9 months following surgery to determine the patency of vein~     grafts created using either the automated PAS-Port or hand sewn methods. Safety will be~     evaluated by documenting the occurence of adverse clinical events and evealuating possible~     association with either method.~   "
244363|NCT00355550|"~     The purpose of this study is to determine whether Ketasyn, a compound that increases energy~     availability in the brain, improves memory in older adults with normal loss of memory~     abilities since early adult life.~   "
244364|NCT00355537|"~     Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male~     hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media~     thickness which are also related to severity of the clinical syndrome of PVD. Artificially~     induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to~     improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot~     study is to assess the effect of testosterone treatment on PVD arterial stiffness and~     intima-media thickness in men with type 2 diabetes and hypogonadism,~   "
244365|NCT00355524|"~     The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug~     enters and leaves the blood and tissues over time), safety, tolerability and antiviral~     activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral~     agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and~     adolescents.~   "
244366|NCT00355511|"~     The purpose of this study is to assess the impact of a multidisciplinary team clinic~     including a clinical pharmacist, a registered nurse (RN), dietician and physician providing~     short-term sub-acute management of patients with heart failure on patient outcomes and the~     quality of medication use. Patients being discharged from the emergency department with a~     diagnosis of heart failure will be eligible for this study. We believe that emergency room~     visits, hospitalization and deaths secondary to heart failure will decrease secondary to this~     program.~   "
244367|NCT00355498|"~     Amyloid senile plaques (SPs) and neurofibrillary tangles (NFTs) are neuropathological~     hallmarks of Alzheimer's disease (AD) that also accumulate in key brain regions in~     association with normal aging. This project will expand an established program in early~     detection and prevention of AD designed (1) to identify presymptomatic persons most likely to~     benefit from early intervention and (2) to provide an objective, noninvasive means to monitor~     therapeutic trials.~   "
244368|NCT00355485|"~     The purpose of this research project is to study the effect of micordermabrasion to try to~     improve the appearance of facial acne. The microdermabrasion machine is a hand-held device~     that directs pressurized aluminum oxide crystals at its target accompanied by a suction~     device. It is not yet clear how much improvement can be seen with these treatments or exactly~     how the skin's response causes these improvements. In this study, we are interested in~     learning how well microdermabrasion works to improve the symptoms of acne.~   "
244369|NCT00355472|"~     This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4~     positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).~   "
244370|NCT00355459|"~     The purpose of this research project is to determine the effects of oral tetracycline such as~     Minocycline (Minocin) on tear film composition and tear lipid (meibomian gland secretions)~     characteristics in patients with chronic Blepharitis and associated dry eyes.~   "
244371|NCT00355446|"~     The purpose of this study is to assay human aqueous for bimatoprost and the presence of any~     metabolites, especially prostaglandin analogs. Hypothesis:Bimatoprost is not metabolized to a~     prostaglandin F-2-alpha analog in human eyes~        -  Bimatoprost levels in human aqueous peak approximately three hours post dosing~   "
244372|NCT00355433|"~     The purpose of this study is to compare first urge, strong urge, and maximum capacity, and~     perception of discomfort during urodynamic testing between room temperature and body~     temperate saline. Twenty-four non-pregnant females referred to the urogynecology clinic for~     bladder testing will be enrolled into the study. Each patient will serve as her own control,~     undergoing the bladder testing with both room temperature and body temperature saline.~   "
245575|NCT00339170|"~     This study will evaluate the effectiveness of a computer-based cognitive enhancement program~     plus a work therapy program at improving productivity, work performance, and quality of life~     in schizophrenic individuals.~   "
244376|NCT00355381|"~     Research shows that patient satisfaction with medical care correlates strongly with how~     satisfied they are with the ease of getting information from their providers regarding their~     medical condition. Although the Internet is a wonderful source of information for patients,~     research has shown that, unmediated, it comprises a potential quagmire of information poorly~     matched to users needs. Providers typically do not have enough time to fulfill all of their~     patients' information needs. One strategy to meeting the patient's information needs is to~     introduce librarians trained and experienced in consumer health information services into the~     relationship between the patient and the provider. One recently described tactic is for~     providers to provide information the way they of provide treatment-through an information~     prescription (IRx) filled by a librarian. The librarian fills the prescription by offering~     information services tailored to the needs of individual patients. At Johns Hopkins, we have~     piloted such a tactic, and in this project, extend and evaluate it. The research hypothesis~     is that provision of an IRx will improve patient satisfaction, provider knowledge and~     attitudes regarding patient information needs, and the efficiencies of care.~   "
244377|NCT00355368|"~     Emergency intubation of patients in intensive care is a high-risk endeavour. For many~     decades, succinylcholine has been the neuromuscular blocking agent of choice. However,~     succinylcholine may have life-threatening side effects and is contraindicated in a variety of~     diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated~     as alternative for succinylcholine. Though a recent meta-analysis found no difference in~     intubating conditions between succinylcholine and rocuronium in elective cases, there are no~     data in emergent cases in intensive care. The aim of the present study is to compare~     succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length~     of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of~     intubation, and 5) desaturations.~   "
244378|NCT00355355|"~     The purpose of the study is to assess the survival of patients treated with Litx™ versus~     standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC),~     and to demonstrate the safety of Litx™ therapy.~      Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology,~     Bellevue, Washington), and a light generating device, composed of light-emitting diodes~     (LEDs), that is energized by a power controller and percutaneously placed in the target~     tissue inside the body.~   "
244379|NCT00355342|"~     This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits~     will include lung function tests and scans of your bones. The purpose of this study is to~     determine the effect of the steroid component of an inhaled product on bone mineral density~     in patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
244380|NCT00355329|"~     We aimed to use Tongue Acupuncture (TAC) to assess for any change in brain function.~   "
244381|NCT00355316|"~     This study is designed to determine whether molecular detection of breast cancer cells in the~     peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of~     progression-free and overall survival. Stage IV breast cancer patients who have measurable~     breast cancer metastases and are initiating a regimen of systemic therapy are eligible for~     enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood~     specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood~     specimens from breast cancer patients will be obtained at the time of study entry (prior to~     initiation of systemic therapy) and at serial time points during follow-up. Subjects will be~     followed longitudinally until death, although the study has been powered so that the primary~     objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to~     provide a blood sample at time of enrollment but will not be followed.~   "
244382|NCT00355303|"~     The purpose of this study is to determine whether induction of labor with vaginal misoprostol~     application will result in fewer cesarean deliveries than vaginal PGE2 gel application in~     women with premature rupture of membranes at term.~   "
244383|NCT00355290|"~     The primary hypothesis of this trial is that changes in oral vitamin K intake, based on~     simple food registries, may be superior to conventional changes in doses of medications in~     order to stabilize chronic oral anticoagulation.~   "
244384|NCT00355277|"~     The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on~     the skin of human volunteers, considering the differential effects on mechanic and thermic~     sensitivity, the local and general tolerance, and the systemic absorption of the drug. The~     solution used for dilution of amitriptyline is the only one known to allow transcutaneous~     absorption of the drug [1]. Considering that the peripheral sensitive fibre is a possible~     site of action of tricyclic antidepressants for relieving neuropathic pain [2,3], this is a~     first step study before further assessment of the therapeutic effects of transcutaneous~     amitriptyline.~   "
244385|NCT00355264|"~     The purpose of this study is to evaluate the ability of Phenoptin to control blood~     phenylalanine levels in subjects who have hyperphenylalaninemia due to a primary BH4~     deficiency and to evaluate the safety of Phenoptin in this population.~   "
244386|NCT00355251|"~     To determine the influence of atorvastatin on plasma viral replication when the latter is~     given before and during highly active anti-retroviral therapy (HAART) in patients with HIV~     infection and viral suppression.~   "
244387|NCT00355238|"~     The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the~     growth of advanced liver cancer. The safety of this treatment will also be studied.~   "
244388|NCT00355225|"~     The study aims at assessing which of two distribution channels for insecticide treated~     bendnets (ITNs), social marketing vs. social marketing coupled with free distribution through~     ante-natal care, is most effective in reaching groups at high risk of malaria, i.e. pregnant~     women and children under 5.~   "
244389|NCT00355212|"~     Ethanol injection has been for many years the standard approach as percutaneous treatment of~     non-surgical early hepatocellular carcinoma in cirrhotic patients. Radiofrequency ablation~     has been proposed as an alternative approach and some retrospective and prospective~     comparative trials indicated its better performance for the local control of the disease in~     comparison to ethanol injection. Some prospective randomized studies from Japan and from~     Taiwan reported also an increase of overall survival in the patients treated by~     Radiofrequency. Aim of this study is to compare the two techniques in a prospective~     randomized trial in western patients.~   "
244391|NCT00355186|"~     Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction~     (SWISS-AMI).~      Study population: Patients with acute myocardial infarction, treated with primary PCI.~      Objective: To determine whether intracoronary infusion of BMCs improves recovery of left~     ventricular function after acute myocardial infarction treated by PCI~      Design: Multi-center, randomized, controlled clinical trial with central core lab analysis~     for MRI.~      Therapy: Intracoronary infusion of BMCs in the infarct related artery at 5-7 days or 3-4~     weeks after successful primary PCI~      Primary Endpoint: Change in global left ventricular ejection fraction (LVEF) at 4 months~     relative to baseline measured by quantitative MRI.~      Secondary Endpoints:~        -  Change in LVEF at MRI at 12 months~        -  Change in regional left ventricular wall motion and thickness at 4 and 12 months.~        -  Change in infarct size at 4 and 12 months as assessed by delayed enhancement technique~          by MRI~        -  Analysis of the myocardial infarct size and transmurality, time to PCI and coronary flow~          characteristics after PCI as predictor of LV remodeling and change after cell therapy~        -  Change in myocardial perfusion at 4 and 12 months~        -  Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)~        -  Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI,~          stroke, hospitalization for cardiac reasons) at 12 months~      Interventions:~        -  Aspiration of 50 ml bone marrow (<24 hours) prior to administration~        -  Intracoronary balloon-based infusion of 10 ml BMCs~        -  Cardiac MRI at baseline (resp. at hospital discharge), at 4 and 12 months~      Therapy groups: Bone marrow-derived stem cells infusion in the successfully revascularized~     infarct related vessel at day 5-7 or day 21-28.~      Control group: Management according to the state of the art medical therapy after~     successful primary PCI.~      Safety: A study independent safety committee will analyze the clinical results after the~     first 60 patients.~   "
244392|NCT00355173|"~     The Lubo cervical collar is a device that simultaneously maintains cervical spine control and~     keeps an open airway in a non-invasive manner. The purpose of the device is to manage~     cervical spine control and airway protection in the trauma patient.~   "
244393|NCT00355160|"~     The study serves to investigate the type and prevalence of non-rhinologic headaches seen~     through a academic otolaryngology practice.The study encompasses survey questionnaires,~     review of CT images, and physical examination/nasal endoscopy findings.~   "
244394|NCT00355147|"~     The purpose of this study is to develop and evaluate the local adaptation of existing stroke~     prevention tools into practice. A stroke prevention program is a collection of materials~     including written materials like pamphlets and brochures, videotapes and training guides for~     stroke survivors and evidence based guidelines for the doctors that provide care for them.~     Other tools that may be used in a stroke prevention program include devices that help~     patients monitor medical symptoms at home like home blood pressure machines or blood sugar~     monitors and messaging devices that allow reporting symptoms from home to a health care~     provider.~      We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would~     engage in better medication compliance and stroke specific quality of life compared to those~     who did not receive the program.~   "
244395|NCT00355134|"~     This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod~     compared to placebo on efficacy parameters in patients with relapsing-remitting multiple~     sclerosis (RRMS).~   "
244396|NCT00355121|"~     The purpose of this study is to evaluate the immunogenicity and safety of the concomitant~     administration of Menactra® vaccine and DAPTACEL® vaccine.~      The main objectives are:~      Immunogenicity:~      To evaluate the antibody responses to both vaccines when Menactra vaccine is given~     concomitantly with DAPTACEL® compared to when either vaccine is given alone.~      Safety:~      To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are~     administered concomitantly compared to when each vaccine is given alone.~   "
244397|NCT00355108|"~     Scientific Objectives Primary objective : Demonstrate that oral intake of tranexamic acid~     significantly reduces the risk of epistaxis occurrence, estimated by the average monthly~     duration of episodes of epistaxis.~      Secondary objectives :~        -  Document the benefit of tranexamic acid on the amount of haemoglobine and quality of~          life of patients.~        -  Identify scalable and genetic factors of response to the treatment by tranexamic acid.~        -  Describe compliance and tolerance of the treatment. Method Experimental Design We~          suggest the realisation of a randomised comparative clinical trial versus placebo, with~          a crossover of random alternated periods of three months over a total of six months.~      Study Population 213 affected patients, displaying sufficiently invalidating epistaxis to~     require a basal treatment, will be recruited and followed every 3 months. Recruitment will~     lean on teams who are part of the national French network in close collaboration with the~     reference centre for the Rendu-Osler disorder, appointed to Lyon on the 19th of November~     2004. Follow up of the study will be carried out by the Clinical Investigational Centre of~     the related towns.~      Outcome measures The main criterion of efficacy is the average duration of epistaxis, the~     secondary criterion of efficacy is the average number of epistaxis measured per month.~     Tolerance will be analysed according to the occurrence of venal or arterial thrombosis and~     allergic accidents. Venal thrombosis will systematically be sought by an inferior limbs~     echodoppler. Response markers will be sought through modelisation incorporating~     environmental, phenotypic and genetic factors.~   "
244398|NCT00355095|"~     The purpose of this study is to determine the safety and efficacy of erythropoietin as an~     add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis.~   "
244399|NCT00355082|"~     This study is being conducted to determine the effectiveness of a lower monotherapy dose of~     lamotrigine than that currently approved.~   "
244409|NCT00354952|"~     Resistance to antibiotics is a major public-health problem and studies linking antibiotic use~     and resistance have shown an association not a causal effect. Utilizing the newer macrolides,~     azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we~     investigated the direct impact of antibiotic exposure on resistance at the individual level.~   "
244410|NCT00354939|"~     Primary objective:~      Difference in frequency of subjects with conventionally detected hypoglycemia by the subject~     [at least one measurement smaller/equal 60mg/dl documented in the 8-point profile in the case~     record form (CRF) or documentation of symptomatic hypoglycemia in the CRF through Visits 8/9]~     compared to CGMS detected blood glucose values smaller/equal 60mg/dl during CGMS measurements~     (at least one measurement through Visits 8/9) after eight weeks of treatment with insulin~     glargine.~      Secondary objective:~      Secondary study objectives were to investigate the safety and efficacy of a treatment change~     to insulin glargine in ICT treated subjects in terms of:~        -  Percentage of blood glucose measurements(CGMS data)smaller/equal 60mg/dl [3.3 mmol/l].~        -  Percentage of nocturnal blood glucose measurements(CGMS data)smaller/equal 60mg/dl[3.3~          mmol/l].~        -  Percentage of daytime blood glucose measurements(CGMS data)smaller/equal 60mg/dl[3.3~          mmol/l].~        -  Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose~          smaller/equal 60mg/dl[3.3mmol/l], area under the curve (AUC greater/equal 180)and time~          (t greater/equal 180) for blood glucose greater/equal 180mg/dl[10.0mmol/l].~        -  Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose~          smaller/equal 60mg/dl[3.3mmol/l]during the day (AUC 06.00am - 10.00pm)and during the~          night(AUC 10.00pm - 06.00am).~        -  Area under the curve (AUC greater/equal 180)and time(t greater/equal 180)for blood~          glucose greater/equal 180mg/dl[10.0mmol/l]during the day (AUC 06.00am - 10.00pm)and~          during the night(AUC 10.00pm - 06.00am).~        -  Frequency of subjects with nocturnal blood glucose value smaller/equal 60mg/dl[3.3~          mmol/l].~        -  Frequency of subjects with asymptomatic nocturnal blood glucose smaller/equal~          60mg/dl[3.3 mmol/l].~        -  Frequency of subjects with symptomatic nocturnal blood glucose smaller/equal 60mg/dl~          [3.3 mmol/l].~        -  Frequency of subjects with daytime blood glucose smaller/equal 60mg/dl [3.3 mmol/l].~        -  Frequency of subjects with asymptomatic daytime blood glucose smaller/equal 60mg/dl[3.3~          mmol/l].~        -  Frequency of subjects with symptomatic daytime blood glucose smaller/equal 60mg/dl[3.3~          mmol/l].~        -  Frequency of subjects with hyperglycemic blood glucose(greater/equal~          180mg/dl,[10.0mmol/l]).~        -  Frequency of subjects with symptomatic hypoglycemia(smaller/equal 60mg/dl [3.3mmol]).~        -  Frequency of subjects with severe hypoglycemia(smaller/equal 36mg/dl [2.0mmol/l]).~        -  Blood glucose values of 8-point profiles.~        -  Mean daytime & mean nocturnal blood glucose of 8-point-profiles.~        -  HbA1c.~        -  Fasting blood glucose (FBG).~        -  Dose of insulin.~        -  Adjustment of insulin.~        -  Body weight, body mass index.~   "
244411|NCT00354926|"~     This study is designed to provide evidence of the safety and a preliminary understanding of~     the efficacy of AME 133v.~   "
244400|NCT00355069|"~     This 3-year, multi-site study focuses on the translation of cost-effective methods to bring a~     chronic care model to the care of poor, minority, inner-city children with asthma, at risk of~     the worst outcomes for the leading chronic disease of children.~      The specific aims are to:~        1. Develop a computer support system to deliver peer-driven, patient-linked Guideline~          prompts at the point of care using affordable information technology;~        2. Evaluate the effect of the Guideline prompt system on the process and outcomes (symptom~          control, health-related-quality-of-life, ED and hospitalizations) of asthma care; and~        3. Evaluate the added effect on outcomes of family-focused, supportive education delivered~          by a community health worker.~      The key product of the computer support system is a guideline prompt that serves as the~     mechanism for integrating patient specific data with standards of care. 548 children, ages~     5-18, with physician diagnosed asthma, enrolled in one Medicaid Managed Care Organization in~     CT, and receiving care at one of four Federally Qualified Community Health Centers will be~     recruited. All sites will have access to the computer support system and the to-be-developed,~     Guideline-Driven Clinical Standards of Asthma Care. In Phase I (12 months), the effect of~     prompts delivered at the point of care on patient outcomes will be compared to the effect of~     no-prompt care. In Phase II (6 months), the effect of family-focused, supportive education~     will be assessed in combination with prompted care compared to no-prompt care and compared to~     no education. All patients will receive standard screening and outreach to keep appointments.~     Data will be obtained from medical records, medical and pharmacy claims data as well as~     patient and parent interviews at baseline and quarterly for 18 months.~   "
244401|NCT00355056|"~     The Purpose of this study is to evaluate the impact of percutaneous closure of a patent~     foramen ovale (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of~     migraine headaches.~   "
244402|NCT00355043|"~     1. Bronchiolitis is a leading cause of morbidity and mortality in children. It is an acute,~     infectious illness of the lower respiratory tract resulting in obstruction of the~     bronchioles. The etiology is viral in the majority of the cases and RSV is the most commonly~     isolated agent. The disease is more common in younger children under 2 years of age. Children~     often receive unnecessary antibiotics and often require hospitalization. An episode of~     bronchiolitis can be followed by recurrent wheezing episodes. RSV bronchiolitis in the first~     year of life is one of the most important risk factors for the subsequent development of~     asthma in both developed and developing countries. Thus, bronchiolitis is a global public~     health problem. Zinc supplementation has been shown to be effective in both preventing and~     treating pneumonia. However, no study has particularly examined the effect of zinc on ARI~     associated with wheezing. This study aims to investigate whether zinc (20 mg/day) reduces1.~     the duration of bronchiolitis in children.2. the severity of bronchiolitis in children.3. the~     rate of hospitalization for bronchiolitis.3. future episodes of wheezing in children.~   "
244403|NCT00355030|"~     The present randomized trial was initially intended to study the benefits of a combined~     treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for~     pubertal children with idiopathic short stature. However, treatments were stopped in January~     2012 at the request of the French drug agency. Therefore, a protocol amendment divided the~     study in two study periods.~      Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with~     somatropin alone. Participants from France who participated in this Period 1 of the study~     were asked to participate in a long term safety follow up defined as a Period 2 of the study.~     Participants from the Netherlands were offered participation in Genetics and~     Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov~     Identifier: NCT01088412) for long term safety follow up independent of this study.~   "
244404|NCT00355017|"~     HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is~     to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM)~     improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after~     discharge.~      Patients hospitalised with cardiac decompensation in 9 Viennese hospitals are randomised to~     BGC, MM alone, or UC. MM includes 2 consultations of a heart failure (HF) specialist 10 days~     and 2 months after discharge for recommending medical optimisation and care by a specialised~     HF nurse including 4 home visits and telephone contact. In addition, BGC includes intensified~     increase of medical treatment during repeated follow-up visits in a HF clinic in patients~     with an Nt-BNP level above 2200pg/ml at discharge.~   "
244405|NCT00355004|"~     RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to~     treat. Computerized and mailed reminders may help increase the rate of colorectal cancer~     screening in adults with an average risk for colorectal cancer.~      PURPOSE: This randomized clinical trial is studying how well computerized and mailed~     reminders work in increasing the rate of colorectal cancer screening in adults with an~     average risk for colorectal cancer.~   "
244406|NCT00354991|"~     The objective of the study is to estimate the percentage of patients who reach blood pressure~     goal after 8 weeks of treatment with losartan/HCTZ combination.~   "
244407|NCT00354978|"~     Objectives:~        1. To estimate progression-free survival (PFS) at 12 months in subjects with metastatic~          colorectal cancer who receive FOLFIRI [folinic acid (leucovorin or LV), 5-Fluorouracil~          (5-FU), irinotecan) plus bevacizumab as first line treatment.~        2. To determine the objective response rate and the duration of objective response in this~          population.~        3. To assess overall survival (OS) in this population.~        4. To measure the effect of treatment on intratumoral blood volume and microvascular~          permeability by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in~          consenting patients in whom it is technically feasible.~        5. To correlate plasma proteomics with response.~        6. To assess the safety of this regimen.~   "
244408|NCT00354965|"~     Clinical research study to test amoxicillin and clavulanate tablet formulation for use in~     Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and~     no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of~     this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR~     in the body after it has been swallowed by children.~   "
244427|NCT00354692|"~     This pilot study will compare the effects of sodium ferric gluconate complex and iron sucrose~     on urine concentrations of various chemicals including protein~   "
244412|NCT00354913|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxyurea, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving imatinib mesylate together with hydroxyurea may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with~     hydroxyurea works in treating patients with recurrent or progressive meningioma.~   "
244413|NCT00354900|"~     There is an intimate relationship between processes which promote growth, invasion, and~     metastasis of cancers, and processes which regulate blood clotting. The enzymes uPA and PAI-1~     are key regulators of the remodeling of recently formed blood clots, and there is substantial~     information linking greater levels of uPA and PAI-1 in breast cancers with a greater~     likelihood of breast cancer recurrence and death. As uPA and PAI-1 are excellent markers for~     a cancer's aggressive clinical behavior, uPA and PAI-1 may be potential targets for~     anticancer therapy. Aprotinin is an inhibitor of uPA activation, and has been approved by the~     FDA to reduce blood loss in patients undergoing cardiopulmonary bypass surgery. Studies in~     animals and limited studies in patients have shown that Aprotinin slows the growth of tumors.~     Our hypothesis is that uPA is chronically activated in malignancies, and that inhibition of~     uPA by Aprotinin would slow the rate of progression of breast cancer.~   "
244414|NCT00354887|"~     Primary Objective:~      1. To determine the objective response rate (complete plus partial) to the combination of~     capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of~     the small bowel and ampulla of Vater.~      Secondary objectives include determining the toxicity, time-to-treatment failure, and overall~     survival rates in patients treated with this combination.~   "
244415|NCT00354874|"~     This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and~     pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre,~     double-blind, placebo controlled, dose ascending, four way cross-over study in approximately~     28 mild to moderate asthmatic subjects.~      Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will~     be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical~     laboratory tests, collection of adverse events (AE) information and blood samples.~   "
244416|NCT00354861|"~     This is a single centre, three single administrations (Days 1, 29 and 57) at increasing doses~     of IMP321 (3, 10, 30 and 100 µg) in four cohorts of 12 subjects, single blind, randomized~     study.~   "
244417|NCT00354835|"~     This randomized phase III trial is studying two different combination chemotherapy regimens~     to compare how well they work when given together with radiation therapy in treating patients~     with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine~     sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination~     chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known~     which combination chemotherapy regimen is more effective when given together with radiation~     therapy in treating patients with rhabdomyosarcoma.~   "
244418|NCT00354822|"~     Pilot multicentre, open label study with the aim to evaluate antitumor activity in term of~     the sum of complete and partial response (O.R.R.) of chemotherapy (cyclophosphamide and~     fludarabine) and rituximab, followed by zevalin radioimmunotherapy and response duration~     (Time to relapse or progression)and to evaluate the safety of the treatment as acute and late~     toxicity.~      Secondary objective is to evaluate the overall survival (OS) and the event-free survival~     (EFS).~   "
244419|NCT00354809|"~     This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9~     days, will promote sleep during the following night without significant post-dose thinking~     impairment and drowsiness in subjects with primary insomnia.~   "
244420|NCT00354796|"~     We hypothesize that reduced dose of enoxaparin in elderly patients will result in reduced~     proportion of patients with therapeutic anti Xa activity and reduced clinical efficacy.~   "
244421|NCT00354783|"~     The purposes of this one-year follow-up study are twofold: (1) to prospectively examine the~     spontaneous kicking and the supported stepping movement in VLBW premature infants until~     attainment of independent walking; and (2) to assess factors (i.e. gross motor development,~     cardiopulmonary function, anthropometry, body composition and cognition) that could~     potentially influence walking attainment in VLBW premature infants.~   "
244422|NCT00354770|"~     This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of~     trichotillomania~   "
244423|NCT00354757|"~     Background/Aim: To evaluate the optimal dosage of rabeprazole for proton-pump inhibitor (PPI)~     testing of gastroesophageal reflux disease (GERD) and to test the influence of cytochrome P~     (CYP) 2C19 polymorphism in a population with a high prevalence of people who poorly~     metabolize PPIs.~      Patients and Methods: In this randomized, open-label trial, patients with symptoms suggestive~     of GERD were randomized to receive a two-week test with 20-mg or 40-mg rabeprazole after~     diagnostic endoscopy. Symptom response was assessed with a four-grade daily record; in~     addition, DNA from peripheral blood leukocytes was genotyped for CYP2C19 polymorphism with~     polymerase chain reaction-restrict fragment length polymorphism (PCR-RFLP) technique.~   "
244424|NCT00354744|"~     RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide,~     etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination~     chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy~     together with radiation therapy works in treating patients with newly diagnosed metastatic~     rhabdomyosarcoma or ectomesenchymoma.~   "
244425|NCT00354731|"~     We aim to investigate (1) the effects of combined pentoxifylline and corticosteroids,~     compared to that of corticosteroids, on patients with primary nephrotic syndrome; and if~     possible (2) the effects of pentoxifylline monotherapy on patients with primary nephrotic~     syndrome not suitable for or intolerant of standard corticosteroid therapy.~   "
244426|NCT00354705|"~     The goal of this research study is to identify biologic and lifestyle factors that may~     increase a person's risk of developing a recurrence (return) of colon cancer.~   "
244428|NCT00354679|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others~     interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the~     growth of esophageal cancer by blocking blood flow to the tumor. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving chemotherapy and monoclonal antibody therapy~     together with radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill~     any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving irinotecan, cisplatin, and~     bevacizumab together with radiation therapy followed by surgery and bevacizumab works in~     treating patients with locally advanced esophageal cancer.~   "
244429|NCT00354666|"~     This study was designed to test safety aspects and effects on lung function of a new dry~     powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with~     previous studies which have only used inhalation of the drug as a vapour.~   "
244430|NCT00354653|"~     The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic~     hepatitis has been well established.The evidence in HBeAg negative patients is limited.~     Limited sustained response was observed post-treatment following a one year treatment period.~     Whether these results can be applied to patients in Iran is uncertain. This study is~     therefore intended to further assess the efficacy profile after two years of open treatment~     in the adult Iranian population.~   "
244431|NCT00354640|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing,~     or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high~     risk of breast cancer.~      PURPOSE: This phase II trial is studying how well giving simvastatin together with~     anastrozole works in treating postmenopausal women with invasive breast cancer, ductal~     carcinoma in situ, or a high risk of breast cancer.~   "
244432|NCT00354627|"~     The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who~     have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability~     aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with~     limited treatment options will be assessed. Available data regarding the effectiveness of the~     drug will also be collected. To be eligible, patients should be failing their current ARV~     regimen or be on a treatment interruption, should have previously received 2 different~     protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease~     inhibitors [PI], nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and~     non-nucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced~     (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination~     with an investigator-selected background of additional ARVs from the list of allowed~     medications.~   "
244433|NCT00354614|"~     The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity~     of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a~     correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic~     PSG and AL.~   "
244434|NCT00354601|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving docetaxel together with carboplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine~     works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian~     tube cancer, or peritoneal cavity cancer.~   "
244435|NCT00354588|"~     1. Cardiovascular risk is high in patients with renal failure.~        2. Cross-sectional studies have indicated a relationship between arterial stiffness and~          renal function. However, there are no prospective longitudinal studies in the~          literature.~        3. In dialysis patients, arterial stiffness as well as wave reflections, predict mortality.~          However, there are no data on patients with mild-to-moderate renal impairment available.~        4. Therefore, we designed a study to test the hypothesis that: a) measures of arterial~          stiffness and wave reflections predict the progression of renal impairment in patients~          with mild-to-moderate renal failure; and b) measures of arterial stiffness and wave~          reflections predict cardiovascular events in patients with mild-to-moderate renal~          failure~   "
244436|NCT00354575|"~     The purpose of our study is to improve the problem of constipation and increase the quality~     of long-term care by the regimen of Chinese herb prescribed by professional doctors of~     Chinese medicine.~   "
244437|NCT00354562|"~     To determine the efficacy of ABT-751 when administered in combination with standard docetaxel~     in subjects with advanced or metastatic NSCLC.~   "
244438|NCT00354549|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and~     gemcitabine at disease progression may be an effective treatment for non-small cell lung~     cancer.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib~     followed by cisplatin or carboplatin and gemcitabine works in treating patients with newly~     diagnosed or recurrent stage IIIB or stage IV non-small cell lung cancer.~   "
244439|NCT00354536|"~     This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess~     safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is~     given at the same dose 7 days apart, and the impact this medication has on various substances~     in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of~     any side effects.~   "
244440|NCT00354523|"~     Objectives:~      Primary objectives:~      To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate,~     capecitabine, and dacarbazine in patients with solid tumors.~      To determine the overall tumor response rate to imatinib mesylate in combination with~     capecitabine and dacarbazine as first line and second line therapy in advanced metastatic~     medullary thyroid carcinoma.~      To determine the tolerability (toxicity) of this regimen.~      Secondary objectives:~      To determine the median overall survival (OS) and time to progression (TTP) for patients~     treated with this combination.~   "
244441|NCT00354510|"~     The purpose of this study is to investigate the clinical efficacy of 3% (w/w) GW842470X cream~     applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema~     Area Severity Index (EASI) assessment of disease severity and to investigate the safety of~     and tolerability of 3% GW842470X cream on diseased skin of adult patients.~   "
244442|NCT00354497|"~     RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to~     treat. The amount of heterocyclic amines in the diet may affect prostate cancer screening~     results and the risk of prostate cancer.~      PURPOSE: This phase II trial is studying prostate cancer screening and dietary heterocyclic~     amines in African American men.~   "
244443|NCT00354484|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45~     compared to the current standard of care in postpartum patients.~   "
244444|NCT00354471|"~     This study will evaluate the safety, efficacy , quality of life and patient satisfaction of~     uterine artery embolization for the treatment of symptomatic uterine fibroids. It will~     provide useful information in the development od guidelines in patient selection, procedural~     management and subsequent follow up.~   "
244445|NCT00354458|"~     The study is being conducted to examine whether KW-3902IV will result in greater improvement~     in signs and symptoms of heart failure, with less treatment failure than standard therapy,~     when it is added to IV loop diuretics in subjects with acute heart failure syndrome and renal~     impairment.~   "
244446|NCT00354445|"~     The purpose of this study is to explore the safety and efficacy of Macugen given as~     maintenance therapy in patients who have had initial success with another AMD treatment.~     Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.~   "
244447|NCT00354432|"~     RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients~     receiving hormone therapy for prostate cancer. It is not yet known whether soy~     protein/isoflavones are more effective than venlafaxine when given together or with a placebo~     in treating hot flashes.~      PURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine~     to compare how well they work when given together or with a placebo in treating hot flashes~     in patients receiving hormone therapy for prostate cancer.~   "
244448|NCT00354419|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood~     stem cell transplant helps stop the growth of abnormal cells. It also helps stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving cyclosporine~     and mycophenolate mofetil before and after transplant may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects and best dose of total-body~     irradiation when given together with cyclophosphamide and antithymocyte globulin in treating~     patients with severe aplastic anemia undergoing umbilical cord blood transplant.~   "
244449|NCT00354406|"~     Abciximab has been demonstrated to improve outcome when administered during primary~     angioplasty in patients with acute myocardial infarction. The Primary Objective of the study~     is to demonstrate that early (before transportation form remote hospital to the cath lab)~     abciximab administration during acute myocardial infarction reduces infarct size as compared~     with late (just prior to PCI) abciximab administration, as measured by delayed enhancement~     magnetic resonance (MR) at 6 months.~   "
244450|NCT00354393|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Cisplatin may also make tumor cells more sensitive to~     radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor~     cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or~     without surgery and chemoradiotherapy works in treating patients with malignant pleural~     mesothelioma.~   "
244451|NCT00354380|"~     The primary objective of this trial is to study the safety of the combination methylene blue~     (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to~     the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of~     MB-AS and MB-AQ.~   "
244452|NCT00354367|"~     To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's~     disease subjects with active draining fistulas.~   "
244453|NCT00354354|"~     Hypothesis: The reduction of dynamic hyperinflation and its negative effects on the~     respiratory system following a bronchodilator could lead to an improvement of cardiac~     function in terms of increased cardiac output. This may enhance oxygen delivery to the~     exercising muscles in COPD patients. Bronchodilator administration may also have an indirect~     effect on V'O2 kinetics via its action on cardiovascular and pulmonary variables.~      Objectives:~        1. To evaluate the effects of a bronchodilators on V'E , V'CO2 , and V'O2 kinetics in COPD~          during constant work-rate cycle exercise, and to evaluate whether bronchodilators will~          accelerate, indirectly, phase 2 kinetics (usually slower in COPD patients than normal~          subjects) and shorten t for V'E, V'CO2 , and V'O2 and shorten half-times for HR and O2~          pulse, thus showing an improvement of oxygen transport to the peripheral active muscles.~        2. To determine the impact of a bronchodilator-induced reduction in dynamic hyperinflation,~          and its effects on cardiovascular and pulmonary function, on exercise limitation in~          COPD.~   "
244454|NCT00354341|"~     This study will assess the effect of anemia correction with NeoRecormon on cardiac structure~     and function in patients with early diabetic nephropathy. The anticipated time on study~     treatment is 1-2 years and the target sample size is 100-500 individuals.~   "
244455|NCT00354328|"~     This study will examine the relationship between certain measures of heart function and~     exercise capacity in patients with hypertrophic cardiomyopathy (HCM).~      Patients who participated in NHLBI studies 01-H-0006 (Double Blind Placebo-Controlled Study~     of Pirfenidone - A Novel Anti-Fibrotic Drug - in Symptomatic Patients with Hypertrophic~     Cardiomyopathy Associated with Left Ventricular Diastolic Dysfunction) and 96-H-0144~     (Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin-Converting Enzyme~     Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced~     Left Ventricular Diastolic Dysfunction) are eligible for this study. Data from~     echocardiograms and measures of left ventricular pressure obtained from patients in those~     studies will be analyzed in the current study to assess their influence on exercise capacity.~     No additional tests, treatments or other procedures are required.~      Information from this study may help in the development of improved drug treatments for HCM.~   "
244456|NCT00354315|"~     The objective of this project is to evaluate the feasibility of a larger randomized trial of~     the efficacy of DECISION+, a continuous professional development program integrating multiple~     components, to promote shared decision making concerning drug prescription.~   "
244457|NCT00354302|"~     RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in~     postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of~     broken bones, and help patients live more comfortably.~      PURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with~     primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.~   "
244458|NCT00354276|"~     RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving VNP40101M followed by cytarabine may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in~     treating older patients with acute myeloid leukemia.~   "
244459|NCT00354263|"~     This study is a single centre, single blind, placebo (step 1) or reference (step 2)~     randomised study. Healthy young male volunteers will receive single ascending dose of IMP321~     in each step (4 doses tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone~     and tested versus placebo (physiological saline). In step 2, the association IMP321 +~     Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.~   "
244460|NCT00354250|"~     This phase II trial is studying how well ispinesib works in treating patients with metastatic~     or unresectable kidney cancer. Ispinesib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
244461|NCT00354237|"~     The aim of the DARE study is to see whether strict glycemic control during cardiac~     rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak~     workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery~     disease.~   "
244462|NCT00354224|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving capecitabine together with~     oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic~     stomach cancer.~   "
244463|NCT00354211|"~     The purpose of this study is to evaluate if the continuous availability of minimally invasive~     cardiac output data during treatment in the intensive care unit (ICU) for hemodynamic~     instability, in comparison to standard of care will shorten the time needed to stabilize the~     patient.~      The researchers hypothesize that early detection of instability improves the prognosis and~     treatment outcome of emergency intensive care patients with hemodynamic instability.~   "
244464|NCT00354198|"~     We have recently demonstrated that pentoxifylline (PTX) has the potential to treat severe~     glomerular inflammation in a rat model of accelerated anti-glomerular basement membrane (GBM)~     glomerulonephritis. This study aims to investigate the therapeutic effects of combined PTX~     and conventional immunosuppressive regimens on patients with rapidly progressive~     glomerulonephritis.~   "
244465|NCT00354185|"~     This phase I trial is studying the side effects and best dose of giving PDX101 together with~     17-AAG in treating patients with metastatic or unresectable solid tumors or lymphoma. PDX101~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth~     and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as~     17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Giving PXD101~     together with 17-AAG may kill more cancer cells.~   "
244466|NCT00354172|"~     RATIONALE: Giving chemotherapy, natural killer cells, aldesleukin, and total-body irradiation~     before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal~     cells and cancer cells. It also helps stop the patient's immune system from rejecting the~     donor's stem cells. When the healthy stem cells from a donor are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets. Sometimes the transplanted cells from a donor can make an immune response~     against the body's normal cells. Giving cyclosporine, mycophenolate mofetil, and~     methylprednisolone before and after transplant may stop this from happening.~      PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide~     together with total-body irradiation followed by donor umbilical cord blood natural killer~     cells, aldesleukin, and umbilical cord blood transplant works in treating patients with~     refractory hematologic cancer or other diseases.~   "
244467|NCT00354159|"~     The purpose of this clinical research study is to evaluate the safety and effectiveness of~     the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with~     an implantable cardioverter defibrillator (ICD). The investigational IHM has the ability to~     record and report the force with which the heart pumps blood (heart pressures). When combined~     with the ICD, the device has the additional ability to send a strong electrical impulse, or~     shock, to the heart when it detects dangerously fast heartbeats to return it to a normal~     rhythm. The IHM and IHM/ICD are implanted surgically just under the skin in the upper chest~     area. This study will also determine how doctors use the information related to heart~     pressures in the management of heart failure.~   "
244469|NCT00354133|"~     Parkinsons' disease is one of the most disabling chronic neurological diseases. It can be~     treated sufficiently until motor complications with fluctuations of mobility and dyskinesias~     develop. The quality of life and the social and occupational functioning is relentlessly~     deteriorating with longer disease duration once the complications of conservative therapy~     develop. High-frequency stimulation of the subthalamic nucleus especially improves the motor~     complications of Parkinson's disease and preliminary data suggest that also the quality of~     life and psychosocial handicap are improved. So far this therapy is only used for patients~     which have already undergone personal, professional and social degradation due to motor~     complications of the disease. The aim of this study is to assess the use of this therapy in~     earlier stages of the disease, when motor complications have just developed and before~     patients are significantly affected in their social and occupational functioning.~   "
244470|NCT00354120|"~     The purpose of this study is to compare Reduced Intensity Conditioning protocols containing~     either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from~     voluntary unrelated donors.~   "
244471|NCT00354107|"~     This phase I/II trial is studying the side effects and best dose of SGN-30 when given~     together with ifosfamide, carboplatin, and etoposide and to see how well they work in~     treating young patients with recurrent anaplastic large cell lymphoma. Drugs used in~     chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as SGN-30, can block cancer growth in different ways. Some block~     the ability of cancer cells to grow and spread. Others find cancer cells and help kill them~     or carry cancer-killing substances to them.~   "
244472|NCT00354094|"~     The purpose of this study is to assess the long term (up to 2 years) safety and tolerability~     of [S,S]-Reboxetine in patients with pain after shingles.~   "
244473|NCT00354081|"~     PURPOSE OF STUDY Observational studies have demonstrated that elevated levels of plasma total~     homocysteine is a risk factor for cardiovascular disease. The purpose of this trial is to~     evaluate the clinical effects of homocysteine lowering treatment with B vitamins during 3-5~     years follow-up of patients undergoing cardiac catheterization for suspected coronary artery~     disease (CAD). Special attention will be given to complication rates among patients needing~     subsequent percutaneous transluminal coronary angioplasty (PCI) or coronary artery by-pass~     grafting (CABG).~      HYPOTHESIS The primary hypothesis of this study is that, among patients with CAD, a daily~     supplement with B vitamins will reduce the risk for cardiovascular mortality and serious~     cardiovascular events with at least 20%. The secondary hypothesis of this study is that,~     among patients with CAD, a daily supplement with B vitamins will reduce the risk for total~     mortality, coronary events, cerebrovascular events and other cardiovascular events. The~     hypothesis will be tested for an effect of any of the treatments (folic acid / vitamin B12 or~     B6), and the effect will be evaluated according to initial total homocysteine levels and B~     vitamin levels as well as to the change in these levels after 1 and 6 months. The sample size~     has been calculated to 3088 patients using a two-sided chi-square test with significance 0.05~     and at an 80% power level, presumed event rate of 22% over 4 years, and event rate reduction~     of 20%, adjusted for non-compliance/drop-out of 20%.~      STUDY DESIGN This is a controlled, double-blind two-centre trial with 3090 included men and~     women who underwent coronary angiography at Haukeland University Hospital or Stavanger~     University Hospital between April 1999 and April 2004. At baseline about 1300 patients~     underwent PCI and 600 underwent CABG. The patients were randomized into 4 groups in a 2 x 2~     factorial design to receive one of the following four treatments: A, folic acid 0.8 mg plus~     vitamin B12 0.4 mg and vitamin B6 40 mg per day; B, folic acid 0.8 mg plus vitamin B12 0.4 mg~     per day; C, vitamin B6 40 mg per day; D, placebo. The active drug and the placebo tablets had~     identical appearance and taste. Treatment was started as soon as the patients were randomized~     after the coronary angiography procedure. The patients have been undergoing interviews,~     clinical examination and blood-sampling at baseline, at follow-up after 1 month and 1 year,~     and at a final study visit. In addition, information on dietary habits was obtained from 2400~     patients at baseline. Among 350 patients that have undergone PCI at baseline, a full clinical~     examination, blood sampling and repeat coronary angiography to assess re-stenosis has been~     performed about 9 (6-12) months after the PCI procedure. For these patients, angiograms~     suitable for quantitative coronary angiography (QCA) analysis have been obtained at the~     baseline and follow-up invasive procedures.~      The follow-up was terminated ahead of schedule in October 2005 due to lack of compliance of~     the participants caused by media reports from the NORVIT study (NCT00266487) on potential~     increased cancer risk associated by B vitamin supplementation. The patients had then been~     followed for 1.5 - 5 years.~      STUDY END POINTS Primary clinical endpoints during follow-up are all cause death, non-fatal~     acute myocardial infarction, acute hospitalization for unstable angina and non-fatal~     thromboembolic stroke (infarction). Secondary endpoints are fatal and non-fatal acute~     myocardial infarction (including procedure related myocardial infarction), acute~     hospitalization for angina, stable angina with angiographic verified progression, myocardial~     revascularization, fatal and non-fatal thromboembolic stroke.~   "
244474|NCT00354068|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving imatinib mesylate together with temozolomide may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate~     when given together with temozolomide in treating patients with malignant glioma.~   "
244475|NCT00354042|"~     This study is designed to look at the safety aspects and effects of repeat inhaled doses of~     GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive~     Pulmonary Disease(COPD).~   "
244476|NCT00354029|"~     The purpose of this study is to determine whether the use of perioperative intravenous S (+)~     ketamine reduces the amount and degree of postoperative pain.~      Furthermore the purpose of this study is to determine whether the use of perioperative~     intravenous S (+) ketamine effects cognitive function in the early postoperative period.~   "
244477|NCT00354016|"~     Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines~     are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for~     Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the~     newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly~     and elderly subjects (CPMP/BWP/214/96).~   "
244478|NCT00354003|"~     The overall goal of the study is to evaluate how research participants in Parkinson Disease~     studies that include brain imaging with a dopamine transporter ligand choose to receive the~     imaging data and what is the impact of the imaging data information on the management of~     their symptoms.~   "
244479|NCT00353990|"~     A study of the bioavailability of insulin after infusion in the duodenum in healthy~     volunteers.~   "
244480|NCT00353977|"~     This study will evaluate the safety and effectiveness of a new vaccine, ALVAC-pp65, in~     boosting immunity to cytomegalovirus (CMV) infection in stem cell transplant donors. CMV is a~     member of the herpesvirus group, which includes herpes simplex virus types 1 and 2,~     varicella-zoster virus (which causes chickenpox), and Epstein-Barr virus (which causes~     infectious mononucleosis). Most adults are infected with CMV, but a healthy immune system~     keeps the virus in check, so that it does not cause harm. In people with a weakened immune~     system, such as transplant recipients, the virus can become reactivated. Medications for~     treating the infection may cause low blood counts and kidney damage, and, in some cases, the~     virus may cause death. The ALVAC-pp65 vaccine is intended to improve immunity against CMV in~     stem cell donors and thereby prevent its reactivation in recipients. It is made from a virus~     that ordinarily infects canaries. The virus is weakened so that it cannot infect the person~     who receives it, and it is modified to carry a copy of a CMV gene called pp65. This gene~     instructs cells to make CMV proteins that the vaccine recipient's immune system can produce~     antibodies to, thus conferring immunity to the disease.~      Persons 18 years of age or older who are scheduled to donate stem cells for a patient in an~     NIH protocol and who are not allergic to eggs, egg products, or other vaccines, may be~     eligible for this study. Candidates are screened with a medical history, physical~     examination, and blood tests.~      Participants receive three vaccinations one week apart beginning at least 3 weeks before the~     scheduled stem cell donation. They are observed for 30 minutes after each vaccination to look~     for any immediate side effects of the vaccine. Approximately 3 tablespoons of blood are drawn~     before each vaccination and 1 week after the last vaccination to evaluate vaccine safety.~     Blood samples are also collected at the screening evaluation, 3 weeks after the start of~     vaccination, and 3 months after the last vaccination to check for CMV immunity.~      Participants keep a diary, recording any reactions to the vaccine and any change in~     medications. They are contacted by telephone for follow-up 3 months after the last~     vaccination to report any additional symptoms.~   "
244481|NCT00353964|"~     The purpose of this study is to evaluate the safety and effectiveness of three concentrations~     of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive~     substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation~     who have undergone cataract extraction with intra-ocular lens implantation.~   "
244482|NCT00353951|"~     The overall objective of GRACE is to combat the resistance of drugs that kill bacteria and~     other germs (antimicrobial) through integrating centres of research excellence and using the~     study of the entire DNA in a cell (genomics) to most appropriately investigate and manage~     community-acquired LRTI.~      Grace-01 is the first study to be undertaken as part of GRACE and the aims of this study are~     to describe the presentation, diagnosis, investigation, management and outcomes for people~     with cough / chest infection in general medical practice in 13 primary care networks in 12~     countries in Europe.~   "
244483|NCT00353938|"~     This study will look at the safety and efficacy of MDMA-assisted psychotherapy in people with~     posttraumatic stress disorder (PTSD).~   "
244527|NCT00353366|"~     GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV)~     vaccine in several countries. In view of its registration in the Philippines, the present~     study will collect data on the safety of the vaccine in the local target population as per~     the Bureau of Food and Drugs Directive.~   "
244484|NCT00353925|"~     The purpose of this study is to learn if kinase, a protein found in the heart, contributes to~     thickening of the heart muscle in people with high blood pressure.~      A protein called myosin causes the heart to contract and relax. It is thought that kinase~     changes myosin to make it work better at different heart rates. This study will try to~     determine if, in some people with high blood pressure, the different forms of this protein~     cause changes in the heart. If the protein affects the size of the heart, it might be~     possible to use it to improve heart function after an injury, such as a heart attack.~      African-Americans with high blood pressure will be eligible for this study. Current data show~     that of almost 900 multi-ethnic individuals, the particular form of kinase under study in~     this project is found exclusively in the African-American population. Study participants will~     have two tubes of blood drawn for DNA testing to determine what form of kinase is present. An~     electrocardiogram will also be done if a recent one is not available. Some people may also~     have an echocardiogram, an ultrasound test to image the heart.~   "
244485|NCT00353912|"~     The purpose of this study is to evaluate the blood pressure lowering effects of a~     valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of~     Black stage II hypertensive patients (MSSBP ≥ 160 mmHg).~   "
244486|NCT00353899|"~     This study will examine ways to establish and standardize normal measurements for children,~     specific to gender, age, and body surface, when using magnetic resonance imaging (MRI). MRI,~     which was introduced in the 1980s, is being used more frequently for children. In this study,~     researchers seek to understand how a child's heart is different from that of an adult, when~     an MRI is used for tests. More children with congenital heart disease are living longer.~     Researchers are looking for a better way to assess their cardiac anatomy and function, and to~     compare findings with normal function.~      Patients ages 8 to 21 in good health and who do not smoke may be eligible for this study.~     There will be a blood or urine test to check for pregnancy in female volunteers who have~     begun menstruating or who are over age 12. Pregnancy test results must be negative for those~     patients to stay in the study. The MRI technique uses a strong magnetic field and radio waves~     to obtain images of body organs and tissues. For that procedure, patients will lie still on a~     table that slides into the enclosed tunnel of the scanner. They will be in the scanner from~     20 to 60 minutes. As the scanner takes pictures, patients will hear knocking or beeping~     sounds, and they will wear earplugs to reduce the noise. Patients will be able to communicate~     with the MRI staff at all times during the scan. At any time, patients or their parents may~     ask that the patients be moved out of the machine. If they would like, patients can bring a~     music CD or listen to a radio station through headphones. Some MRI techniques require~     monitoring while the patient is undergoing the scan. For monitoring of the heart, an~     electrocardiogram (EKG) will be performed to make sure that the heart rhythm is normal and~     that heart disease is not present. Patients may be asked to wear adhesive patches that are~     attached to wires of the EKG machine on their chests. To monitor breathing, patients may be~     asked to wear a rubber belt that stretches as they take a breath. So that the best quality~     images are produced, patients may be asked to hold their breath for about 15 seconds.~      During the MRI scan, patients may experience peripheral nerve stimulation, usually~     experienced as a muscle twitch. It is caused by rapid switching of magnetic fields and is not~     serious. Patients who feel a muscle twitch should report that sensation to the person~     performing the scan. It is possible, though unlikely, for a painful sensation to result from~     nerve stimulation. Patients should immediately report if they have pain so that the scan can~     be stopped.~   "
244487|NCT00353886|"~     The specific aim of this study is to determine if in utero exposure produces differential~     antiepileptic drug (AED) effects on subsequent cognitive abilities and behavioral~     abnormalities in children~   "
244488|NCT00353873|"~     This study will compare two treatment strategies (doubling the dose of inhaled steroids or~     adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not~     controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one~     inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.~   "
244489|NCT00353860|"~     This study will evaluate the safety and effectiveness of stem cell transplantation in which~     the donor s T cells (a type of lymphocyte, or white blood cell) have been removed and then~     added back. Certain patients with bone marrow malignancies undergo transplantation of donated~     stem cells (cells produced by the bone marrow that mature into the different blood components~     white cells, red cells and platelets) to generate new and normally functioning bone marrow.~     However, T-cells from the donor may see the patient s cells as foreign and mount an immune~     response to reject them, causing what is called graft-versus-host-disease (GVHD). Therefore,~     in this study, T-cells are removed from the donor cells to prevent this complication.~     Nevertheless, there are disadvantages of removing the T-cells, since they are important in~     fighting viral infections as well as any remaining malignant cells. The attack against the~     malignant cells is called a graft-versus-leukemia effect. Therefore, donor T cells are given~     to the patient (added back) later (45 and 100 days after the transplant) when they can~     provide needed immunity with less risk of causing GVHD.~      Patients between 10 and 55 years of age with chronic myelogenous leukemia, acute~     lymphoblastic leukemia, acute myelogenous leukemia, a myelodysplastic syndrome,~     myeloproliferative disorders, or chronic lymphocytic leukemia may be eligible for this study.~     Prospective participants and their donors are screened with a medical history and physical~     examination, blood tests (including a test to match for genetic compatibility), breathing~     tests, chest and sinus X-rays, and tests of heart function. They also undergo a bone marrow~     biopsy and aspiration. For this procedure, done under local anesthetic, about a tablespoon of~     bone marrow is withdrawn through a needle inserted into the hipbone.~      Participants may undergo apheresis to collect lymphocytes for research studies. This~     procedure involves collecting blood through a needle in the arm, similar to donating a unit~     of blood. The lymphocytes are then separated and removed by a cell separator machine, and the~     rest of the blood is returned through a needle in the other arm.~      Before treatment begins, patients have a central venous catheter (flexible plastic tube)~     placed in a vein. This line remains in place during the stem cell transfusion and recovery~     period for drawing and transfusing blood, giving medications, and infusing the donated cells.~     Preparation for the transfusion includes irradiation and chemotherapy. Patients undergo total~     body irradiation in 8 doses given in two 30-minute sessions a day for 4 days. Four days~     before the transfusion, they begin taking cyclophosphamide, and 9days before the procedure~     they start fludarabine. These are anti-cancer drugs that kill the cancer cells and prevent~     rejection of the donated cells. While the patient is receiving chemotherapy, the donor~     receives daily injections for 6 days of G-CSF, a drug that moves stem cells from the bone~     marrow into the blood stream. On days 1 and 2 after chemotherapy is completed, the stem cells~     are infused into the patient through the central line.~      Patients usually stay in the hospital about 20 to 30 days after the transplant to recover~     from treatment side effects, which may include fever, nausea, diarrhea and mouth pain, and~     receive blood transfusions, if needed. Treatment with cyclosporine, a drug that helps~     prevents both rejection of donated cells and GVHD, is started on day 44 one day before the~     first T-cell add-back. Patients return to the clinic for follow-up with various tests,~     treatments and examinations as required, with a minimum of visits at least once or twice a~     week for 2 to 4 months after the transplant; then at 4, 6, 9, and 12 months, and then yearly~     for at least 3 years.~   "
244490|NCT00353847|"~     The purpose of this study is to determine whether acupuncture is effective and safe in the~     treatment of chronic LBP.~   "
244491|NCT00353834|"~     The main goals of the study are to evaluate the effect of Exenatide on endothelial-dependent~     vasodilation, as measured by flow mediated dilation (FMD), to evaluate the effect on~     endothelial-independent vasodilation, as measured by nitroglycerin (TNG) response, and to~     evaluate the effect on arterial stiffness, as measured by pulse wave analysis (PWA). We will~     also measure the effects on various markers of endothelial function, subclinical~     inflammation, fibrinolysis, and oxidative stress. The control group for the study will~     receive Lantus insulin, with a goal of similar glycemic control between the treatment and~     control groups.~      Specific Aims~      We will test the following hypotheses:~        1. Treatment of patients with type 2 diabetes who are inadequately controlled by~          monotherapy with a Sulfonylurea (SU) or Metformin, or on combination therapy of a SU and~          Metformin with Exenatide (GLP-1 mimetic) will result in improved endothelial dependent~          vasodilation, as measured by FMD, as compared to the control group, who will be treated~          with Lantus insulin to achieve comparable HbA1c levels.~        2. Treatment with Exenatide (GLP-1 mimetic) will result in improved arterial stiffness, as~          measured by AI by PWA, as compared to the control group, who will be treated with Lantus~          insulin to achieve comparable HbA1c levels.~        3. Endothelial dependent vasodilation, as measured by FMD, and arterial stiffness, as~          measured by AI, measured in the postprandial state (following a standard test meal) will~          be improved following treatment with Exenatide as compared to treatment with once daily~          basal insulin (Lantus).~        4. Treatment will result in no improvement in endothelial-independent vasodilation, as~          measured by a response to TNG, as compared to the control group, who will be treated~          with Lantus insulin to achieve comparable HbA1c levels.~        5. Treatment with Exenatide, compared with treatment with Lantus, will result in a~          reduction in various plasma markers of inflammation (CRP, TNFA, IL6), endothelial~          activation (ICAM, VCAM, endothelin 1), fibrinolysis (PAI-1 protein, PAI-1 activity), and~          oxidative stress (FOX2).~   "
244492|NCT00353821|"~     This study seeks to investigate the factors that may account for the differences in the way a~     stem cell recipient s immune system works after a transplant. It will focus on cytokine~     genes, which give specific instructions to the genes and which may influence immune system~     response. More specifically, the purpose of the study is to find out how gene polymorphisms~     (gene variations among the population) affect the success or failure of a stem cell~     transplant.~      Study participants will have donated blood for a stem cell transplant. They will be asked to~     give consent for NIH personnel to run special tests on these blood samples, which will have~     been placed in storage. It is hoped that blood samples will be studied from 600 stem cell~     donors.~   "
244493|NCT00353808|"~     The purpose of this study is to assess the long-term safety and tolerability of~     [S,S]-Reboxetine in patients with chronic pain following shingles. This is the extension~     study of Protocol A6061026.~   "
244494|NCT00353795|"~     The overall goal of this study is to use MRI to:~        -  Examine the relationship between known risk factors for cardiovascular disease and~          coronary artery wall thickness;~        -  Examine the relationship between coronary artery wall thickness and other markers of~          subclinical coronary atherosclerosis, such as carotid wall thickness and coronary~          calcium scores; and,~        -  Examine the feasibility of measuring the progression of coronary artery wall thickness~          over time in a subset of participants.~   "
244528|NCT00353353|"~     In the Netherlands fortification of food products is not yet mandatory. One of the major~     arguments of the Dutch Health Council to advise against mandatory fortification is the~     possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the~     possibility of masking is: fortification of foods with both folic acid and vitamin B12. In~     this study we want to assess the effects of this fortification strategy on markers of folate~     and vitamin B12 status.~   "
246545|NCT00326040|"~     The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular~     micro-bypass stent in reducing intraocular pressure (IOP) in refractory open-angle glaucoma~     subjects.~   "
244495|NCT00353782|"~     This study will evaluate people with dyslipidemias - disorders that affect the fat content in~     the blood. Fats, or lipids, such as cholesterol and triglycerides, are carried in the blood~     in particles called lipoproteins. These particles are involved in causing blood vessel~     diseases that can lead to conditions like atherosclerosis (hardening of the arteries) or~     heart attack. Participants will undergo accepted medical tests and procedures to evaluate~     their condition. Most of the test results are helpful in making a diagnosis and in guiding~     treatment.~      People with lipid disorders are eligible for this study. Representative types of patients~     include those with:~        -  Plasma cholesterol levels greater than 200 mg/dl or less than 120 mg/dl~        -  Plasma LDL-C levels greater than 130 mg/dl or less than 70 mg/dl~        -  Plasma HDL-C levels greater than 70 mg/dl or less than 25 mg/dl~        -  Unusual cholesterol deposits or xanthomas (nodules of lipid deposits on the skin)~      Children under 2 years of age are excluded from the study.~      Participants will undergo some or all of the following procedures:~        -  Plasma evaluation. Apolipoproteins (plasma proteins involved in metabolism of~          cholesterol, triglycerides, phospholipids, and proteins in the blood) and enzymes~          involved in lipid metabolism are measured.~        -  Fat biopsy. A small sample of fat tissue is collected for examination. For this test, an~          area on the buttock or abdominal wall is numbed. A needle is inserted into the fat, and~          a small amount of tissue is sucked out by a syringe.~        -  Leukapheresis. White blood cells are collected to help diagnose the lipid disorder. For~          this test, blood is collected through a needle in an arm vein, similar to donating~          blood. The blood circulates through a machine that separates it into its components, and~          the white cells are removed. The rest of the blood is returned to the body, either~          through the same needle or through another needle in the other arm.~        -  Skin biopsy. Skin cells are collected for study. The cells are grown in the laboratory~          and the amount of cholesterol that enters or leaves the cells is measured, providing~          information on abnormalities in cholesterol transport. For this test, an area of skin is~          numbed with an anesthetic and a small circular area is removed, using a skin punch~          instrument similar to a sharp cookie cutter.~        -  Heparin infusion study. Heparin, a blood thinner, releases enzymes that break down fat~          in the blood. Lipase activity (breakdown of fats) in the blood is measured following the~          injection of heparin into a vein.~   "
244496|NCT00353769|"~     The purpose of this study is to compare the effectiveness, complications and benefits of Hair~     Apposition Technique(HAT)performed by nurses or doctors.~   "
244497|NCT00353756|"~     The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in~     patients with Crohn's disease.~   "
244498|NCT00353743|"~     The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of~     clinical improvement, the patient is discharged from the hospital without antibiotics. No~     trials has been found in cases of septic abortion.~      The purpose of the present study is to verify the need of antibiotics after clinical~     improvement in cases of septic abortion.~   "
244499|NCT00353730|"~     This study will identify genes and proteins in the blood of patients with atherosclerosis and~     in that of normal volunteers. The findings will be compared to determine the influence of~     these substances on the development of atherosclerosis a narrowing and hardening of blood~     vessel walls by deposits of fatty substances. Blood vessel blockage caused by atherosclerosis~     can impede blood flow and cause stroke, heart attack and poor limb circulation. The~     information from this study may lead to better ways to detect, prevent and treat these~     diseases.~      Healthy volunteers and patients scheduled for carotid endarterectomy at Suburban Hospital in~     Bethesda, Maryland, are eligible for this study. Carotid endarterectomy is a surgical~     procedure in which the inner layer of the carotid artery (neck artery supplying blood to the~     brain) is scraped away to open the blocked vessel. Participants will undergo the following~     tests and procedures:~      Patients~        -  Blood sample: Collection of about 32 cc (8 tablespoons) of blood for genetic and protein~          analysis~        -  Tissue sample: Collection of a piece of diseased blood vessel discarded from the~          endarterectomy procedure~        -  Review of records: Review of medical records for information about past illnesses,~          medications, tests, and so forth, if needed~      Normal Volunteers~        -  Blood samples: Collection of about 32 cc (8 tablespoons) of blood for genetic and~          protein analysis~        -  Carotid artery ultrasound: Ultrasound imaging of the neck arteries for detection of any~          blockage~        -  Electrocardiogram: Recording of the electrical activity of the heart to detect any~          abnormalities in heart rhythm~        -  Echocardiogram: Ultrasound examination to detect possible abnormalities of the heart~          muscle~        -  Cardiac stress test: Treadmill stress test to detect possible heart vessel blockage (for~          subjects who have not had a cardiac stress test in the past year)~        -  Review of records: Review of medical records for information about past illnesses,~          medications, tests, and so forth, if needed~   "
244500|NCT00353717|"~     Basal like breast carcinoma is a Her2, estrogen receptor (ER) progesterone receptor (PR)~     negative breast cancer. It is notable for the high level of epidermal growth factor receptor~     (EGFR) expression in this tumor subtype .~      Thus the investigators wanted to combine the use of anti EGFR therapy in the form of Erbitux~     (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of these women.~     This is a small phase I/II study.~   "
244501|NCT00353704|"~     The purpose of this study is to determine whether the use of oral pregabalin 150 mg as~     premedication reduces the amount and degree of postoperative pain.~      Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150~     mg as premedication reduces anxiety prior to anaesthesia in these patients.~   "
244502|NCT00353691|"~     To compare the change in glycemic control from baseline to endpoint (last available~     posttreatment assessment) as measured by HbA1c in pediatric subjects with type 2 diabetes~     receiving either glimepiride or metformin as monotherapy.~   "
244503|NCT00353678|"~     The purpose of this study is to find the best possible (optimal) dose (effect versus adverse~     events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement~     surgery.~   "
244504|NCT00353665|"~     The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate~     affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the~     calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the~     progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the~     single drug approved to treat ALS).~   "
244505|NCT00353652|"~     Thiazide medications are often prescribed for individuals with high blood pressure, but~     research has shown that they may increase an individual's risk of developing diabetes. While~     it is unknown exactly how thiazide causes this response, it is likely that the nervous system~     is somehow involved. This study will evaluate the role of the nervous system in sugar~     metabolism, as well as determine the effect of thiazide and other medications on individuals~     with high blood pressure.~   "
244506|NCT00353639|"~     This study will evaluate and compare the genes of the telomere repair complex in healthy~     control subjects, patients with blood diseases, and patients with inflammatory bowel disease~     to identify what, if any, changes are associated specifically with inflammatory bowel~     disease.~      Patients between 2 and 80 years of age with ulcerative colitis or regional enteritis may be~     eligible for this study. Participants are recruited from the practice of Dr. Stuart~     Danovitch, Washington, D.C.~      Researchers have established that minor differences in a specific set of genes called the~     telomere repair complex are related to immune-mediated diseases of the bone marrow. NIH~     researchers are now interested in whether inflammatory bowel disease and other autoimmune~     diseases show a similar pattern of genetic differences.~      Participants provide a cell sample for evaluation of the telomere repair complex. The sample~     is collected via buccal swab, a gentle scraping of the inside of the cheek, and stored for~     use in research.~   "
244507|NCT00353626|"~     Post traumatic amputees with an experience of over 3 months of prosthesis use at home,~     without any known difficulty using the prosthesis and without stump pathology, using no~     assistive devices, will be examined in a 3 D computerized gait laboratory. Kinematic and~     kinetic parameters of gait will be obtained.~   "
244509|NCT00353600|"~     A clinical intervention will be performed in adult diabetic Pima Indians with proteinuria to~     determine if an angiotensin converting enzyme (ACE) inhibitor is effective in slowing the~     progression of renal disease in persons with overt diabetic nephropathy attributable to type~     2 diabetes mellitus (NIDDM).~      The study will be conducted in the Gila River Indian Community and include proteinuric~     subjects selected from the Diabetic Renal Disease Study (DRDS; NIH Protocol Number 88-DK-79)~     in whom glomerular function has been measured at six-monthly intervals for the past 48~     months. Twenty-five subjects (12 men, 13 women) aged 31-64 years are eligible for this study.~     These subjects all have urinary albumin-to-creatinine rations >=300 mg/g (equivalent to 300~     mg albumin/day), serum creatinine concentrations < 3.0 mg/dl, and no evidence of nondiabetic~     renal diseases. Their GFR slopes average -0.49 ml/min/month (95% confidence interval, -0.91~     to -0.07), and 11 of them (8 men, 3 women) are hypertensive (systolic blood pressure >=140 mm~     Hg, diastolic blood pressure >=90 mm Hg).~      Subjects will be treated with an ACE inhibitor, and measurements of glomerular filtration~     rate (GFR) and renal plasma flow (RPF) will be made at six monthly intervals until the~     subjects' progress to renal failure. GFR slope (ml.min/month) will be computed, and the slope~     prior to the initiation of an ACE inhibitor will be compared with that obtained during~     treatment.~   "
244510|NCT00353587|"~     This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled~     phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients~     with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be~     adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or~     pre-mixed (e.g., 70/30) insulin, or a combination of insulin and one or two non-TZD~     hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly~     controlled on their existing therapy. Preference for enrollment will be given to patients on~     insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic~     agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for~     the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking~     fixed doses of a short-acting insulin (e.g., not a sliding scale) in combination with~     intermediate-acting insulin may qualify for the study if both the patient and investigator~     are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the~     short acting insulin for at least 26 weeks. Patients treated with a sliding scale of~     short-acting insulin will not be eligible for enrollment.~   "
244511|NCT00353574|"~     This is a research study of a new experimental drug called darusentan. Darusentan is not~     currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in~     the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is~     to evaluate the long-term safety of darusentan in subjects with resistant systolic~     hypertension despite treatment with full doses of three or more antihypertensive medications,~     including a diuretic.~   "
244512|NCT00353561|"~     Clinical and mycological response to oral fluconazole and boric acid suppositories was~     assessed in patients with diabetes mellitus and vulvovaginal candidiasis.~   "
244513|NCT00353548|"~     This study will use a sipping and spitting exercise to better understand the brain's response~     to food intake in people with eating disorders.~   "
244514|NCT00353535|"~     The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF~     and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the~     renal graft~   "
244515|NCT00353522|"~     This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with~     coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12~     weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily~     for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level~     and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12~     months, and the target sample size is 100-500 individuals.~   "
244516|NCT00353509|"~     Prospective mono-center clinical study to evaluate the safety and effectiveness of an~     intracardiac septal closure device in patients with atrial septum defect (ASD)~   "
244517|NCT00353496|"~     The study will compare the difference between lanreotide Autogel and placebo on progression~     free survival in patients who have an endocrine tumour in the pancreas or intestines.~   "
244518|NCT00353483|"~     The main purpose of this study is to compare genetic markers present on tumor cells before~     and after chemotherapy.~   "
244519|NCT00353470|"~     This study will determine the relative effectiveness of three psychotherapies in treating~     people with a panic disorder.~   "
244520|NCT00353457|"~     This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab~     (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by~     surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced~     resectable rectal cancer.~   "
244521|NCT00353444|"~     The purpose of this study is to determine whether Transcranial Doppler measurements have~     correlation with neuropsychological test (Galvestone Orientation Amnesia Test), TC image~     (Marshall Scale) and prognosis (DRS and GOS) in moderate head injury~   "
244522|NCT00353431|"~     The aim of this study is to test the safety and efficacy of a new algorithm for intensive~     s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose~     concentration ≥ 8 mmol/l)~   "
244523|NCT00353418|"~     This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg~     weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg~     daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment~     will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
244524|NCT00353405|"~     This study will evaluate the joint and separate effectiveness of two HIV/STD prevention~     programs in providing protection against acquiring STDs and maintaining safer sex behavior.~   "
244525|NCT00353392|"~     The purpose of this study is to determine whether Q-Switched Nd:YAG Laser therapy are~     effective in reduction of Cutaneous macular amyloidosis.~   "
244526|NCT00353379|"~     This study will determine the effectiveness of guanfacine in improving cognitive and~     functional impairments in schizotypal personality disorder.~   "
244530|NCT00353327|"~     To study the effect of passive immunotherapy (PIT) over the HIV-viral load and the CD4~     T+-cell counts in patients who have failed to respond to three different Highly-Active~     Antiretroviral Therapy (HAART), and who have at the moment less than 100 CD4+-T cells/ml and~     a viral load over 20,000 copies/ml.~   "
244531|NCT00353301|"~     The purpose of this study is to test the safety and efficacy of the combination of erlotinib~     hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with~     metastatic kidney cancer.~   "
244532|NCT00353288|"~     As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in~     most industrialised countries and varicella vaccination is now being introduced in many~     countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine~     was developed for administration convenience and improved compliance to vaccination. To~     account for situations where children have received a first dose of MMR vaccine without~     varicella, this study will evaluate the effect of the combined~     measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A~     second dose of the monovalent varicella vaccine will be given to all children participating~     to this trial since there is a current debate on the need of a second dose to induce a full~     protection against varicella.~   "
244533|NCT00353275|"~     The primary purpose of this study is to evaluate two glycemic control regimens on clinical~     outcome in patients with necrotizing soft tissue infections. Secondary aim is to evaluate the~     inflammatory and immune responses to the glycemic control regimens.~   "
244534|NCT00353262|"~     This single arm study will investigate possible pharmacokinetic interactions between Xeloda~     and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is~     influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic~     analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a~     treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in~     cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study~     treatment is 3-12 months, and the target sample size is <100 individuals.~   "
244535|NCT00353249|"~     This study will determine the effectiveness of cognitive behavioral therapy in treating~     post-traumatic stress disorder in homeless women.~   "
244536|NCT00353236|"~     Delivery of twins or preterm infant is a very stressful episode to mothers. The purpose of~     this study is to characterize maternal psychological resources in dealing with this situation~     and compare it to mothers giving birth to singleton at term~   "
244537|NCT00353223|"~     This study will evaluate the effectiveness of interpersonal psychotherapy and behavioral~     activation techniques in treating depression in people with congestive heart failure.~   "
244538|NCT00353210|"~     Human embryonic stem cells (hESCs) are isolated from the early human embryo and have the~     capability to proliferate indefinitely in culture and to develop into nearly every cell of~     the human body. hESC are important for studying developmental biology and for cell~     replacement therapies for the treatment of degenerative human diseases. An additional use for~     embryonic stem cells would be for the in vitro study of diseases. hESC lines derived from~     embryos diagnosed as abnormal by PGD testing would afford such models for study. Because~     embryos tested by PGD and found to be abnormal would only under rare circumstances be~     transferred to the uterus of a woman (and in most cases would be discarded), the derivation~     of new hESC lines from these embryos would provide a viable less ethically-objectionable~     source of cells with which to study the mechanisms of differentiation and developmental~     biology.~   "
244539|NCT00353197|"~     Human embryonic stem cells (hESCs) are isolated from the early human embryo and have the~     capability to proliferate indefinitely in culture and to develop into nearly every cell of~     the human body. Therefore, hESCs may serve as a renewable unlimited source of cells for~     transplantation therapy. Because of the use of animal products in their derivation, and due~     to the lack of appropriate quality and process controls in the manufacturing of existing cell~     lines worldwide, existing hESC lines are not suitable for utilization in transplantation~     therapy.~      Our objective is to derive several new hESC lines that will be suitable for clinical trials.~     The investigators plan on deriving the new hESC lines utilizing only FDA-approved raw~     materials in a non-animal culture system. They will be produced entirely under GMP~     conditions, using appropriately documented procedures and analytical methods, completely~     safety tested, and screened for infectious and adventitious agents.~   "
244540|NCT00353184|"~     Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to~     investigate whether the addition of oral montelukast to standard therapy for acute asthma~     exacerbations results in further improvement in breathing function over three hours.~   "
244541|NCT00353171|"~     This study will examine whether exposure to organochlorines (certain chemicals such as PCBs~     and DDE, used in pesticides or other industrial applications) is related to age at natural~     menopause. It is known, for example, that smokers experience menopause 1 to 2 years earlier~     than do non-smokers. This study will look for a similar association between organochlorine~     exposure and menopause. It will also look for possible associations between specific factors,~     such as pregnancy history and weight change, and changes over time in blood organochlorine~     levels.~      Women who participated in the North Carolina Infant Feeding Study between 1978 and 1982 are~     eligible for this study. Participants will be interviewed over the phone for information~     about their reproductive and menstrual history, as well as additional information that may be~     related to age and menopausal status. Specifically, the interview will cover the following~     areas: 1) pregnancy and breastfeeding history; 2) menstrual periods and menopause; 3) use of~     birth control pills and hormone replacement therapy; 4) surgeries on the uterus or ovaries,~     such as hysterectomy or oophorectomy, or both; 5) smoking and alcoholic beverage consumption;~     6) physical activity; 7) weight history; and 8) medical history. About one-half of the~     participants will have a blood sample drawn for analysis of the reproductive hormones FSH~     (follicle-stimulating hormone) and LH (leuteinizing hormone) and of DDE and PCB levels.~   "
244553|NCT00353002|"~     All patients undergoing venepuncture or venous cannulation in pediatric emergency department~     will be treated with either Amethocaine, or Liposomal Lidocaine (4%) cream at the site of~     cannulation in order to determine the efficacy of these creams in controlling pain during~     procedures and to determine the success rate of these procedures.~   "
244554|NCT00352989|"~     The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool~     weight, when compared to placebo, in the treatment of acute diarrhoea in children.~   "
244542|NCT00353158|"~     This study will examine the phototoxicity, a reaction to light that is like exaggerated~     sunburn, which occurs in people who take medications such as voriconazole, a medication used~     to fight fungus. Sunscreens might protect the skin from the reaction. Although phototoxicity~     from voriconazole is not completely understood, it may be related to how that medication is~     metabolized in the liver by enzymes called cytochrome P450 enzymes-and mainly by one known as~     2C19. A way to evaluate phototoxicity is through microarrays, which measure how much each~     gene is expressed in cells from tissues such as skin.~      Patients ages 8 and older who are scheduled to begin taking or who currently take~     voriconazole may be eligible for this study. Also, patients ages 18 to 45 in good health who~     have skin tone known as Type 2, which usually burns and tans only slightly following sun~     exposure, may be eligible. All patients will visit the Dermatology Clinic. They will complete~     two questionnaires, on medical history and medications, as well as the skin response to~     sunlight, and donate about 3 teaspoons of blood. Patients who are scheduled to take~     voriconazole will visit the clinic four times, that is, two visits 2 consecutive days before~     beginning the medication and two visits on 2 consecutive days after taking it for at least 7~     days. Each visit will take 1 to 2 hours. Patients about to take voriconazole will have a~     blood test and undergo a physical exam of the skin test site, on the buttocks. Researchers~     will take photographs of the specific site and do tests to measure skin reaction to~     ultraviolet (UV) light. UV light will be shined on 15 small areas of the skin, each 1 x 1~     centimeters. After 24 hours, any redness that occurs on the skin will be checked. Afterward,~     patients will begin taking voriconazole according to directions by the researchers. At 10 or~     more days later, patients will visit the clinic. Sunscreen will be applied and 1 hour later~     after administration of voriconazole, a blood sample will be drawn to check the level of~     medication. Then UV light will be shined on 23 areas of skin 1 x 1 centimeters. More~     photographs will be taken of test sites to record changes in skin redness. On the next day,~     the skin response will be evaluated. Participants in the control group will be asked to avoid~     UV radiation by wearing hats and clothing, and using sunscreen. They will be given the~     doxycycline, an antibiotic, and undergo procedures with UV light shined on small areas of the~     skin, on the buttocks. Control participants will have 7 study days, with visits lasting from~     1 to 3 hours and probably not exceeding 8 hours. They will have two shave biopsies on Study~     Day 2 and on Study Day 7 to determine how the skin has responded to UV light exposures.~   "
244543|NCT00353145|"~     Primary objectives:~        1. To determine the overall tumor response rate with oxaliplatin in combination with~          gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer~          (UPC).~        2. To determine the tolerability (toxicity) of this regimen in this patient population.~      Secondary objectives:~        1. To determine the median overall survival (OS) and time to progression (TTP) for patients~          treated with this combination.~        2. To determine the impact of this combination on quality of life (QOL) in this patient~          population.~   "
244544|NCT00353119|"~     Palmoplantar pustulosis (PPP) is a chronic recurrent skin condition characterized by the~     presence of pustules, erythema and hyperkeratosis on palms and soles. PPP can be a severe and~     disabling disease limiting the ability to walk or work. Although studies on the quality of~     life of patients with PPP are not available, a recent investigation showed that palmoplantar~     psoriasis (non pustular) has a more important impact on quality of life than plaque~     psoriasis. This important impact on quality of life is not surprising as palmoplantar~     psoriasis as well as palmoplantar pustulosis may limit the ability to work or conduct~     activities with hands or even impair walking. The disease is sometimes associated with~     psoriasis elsewhere on the body. Current treatments for PPP include topical corticosteroids,~     cyclosporine, PUVA therapy, methotrexate and acitretin. Response to topical corticosteroids~     and PUVA therapy is often disappointing presumably because the thickness of the stratum~     corneum on palms and soles prevents good penetration of topical medications and light.~     Cyclosporine and methotrexate are sometimes used with success for PPP but there are concerns~     with long term toxicity of both drugs. Therefore there is a need for new treatments for PPP.~   "
244545|NCT00353106|"~     Primary Objectives:~        1. To explore the experience of chronic graft-versus-host disease (cGVHD) following~          allogeneic blood or marrow transplantation from the perspective of the patient and the~          patient's primary family caregiver.~        2. To develop and validate an instrument to measure the severity of multiple symptoms and~          the impact of these symptoms on daily functioning in patients who have cGVHD.~      Secondary Objectives:~        1. To develop a detailed description of the experience of having cGVHD.~        2. To develop a detailed description of the symptom experience of cGVHD to allow for~          development of a symptoms instrument for cGVHD.~        3. To assess the understanding of questions to measure the symptoms of cGVHD in patients~          with various levels of education.~        4. To develop a detailed description of caring for a patient with cGVHD.~   "
244546|NCT00353093|"~     Currently, patients with suspected deep vein thrombosis (DVT) of the lower extremities~     receive the ultrasound investigation of their deep vein system, either by limited~     ultrasonography (ultrasonography confined to the proximal veins, repeating the test after one~     week in patients with positive D-dimer) or by extended ultrasonography (ultrasonography~     extented to the entire deep vein system of the legs). No study has directly compared the two~     strategies to assess their accuracy and safety. We plan to compare the accuracy and safety of~     the two strategies in a prospective randomized study addressing more than 2000 consecutive~     outpatients presenting with the clinical suspicion of DVT.~   "
244547|NCT00353080|"~     To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or~     increasing bone mass in lumbar spine in osteopenic postmenopausal women~      To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in~     maintaining or increasing bone mass in proximal femur and decreasing bone resorption~      To confirm general safety of 5 mg daily risedronate as compared to placebo~   "
244548|NCT00353067|"~     The purpose of this study is to determine if veliflapon (DG-031)can prevent a heart attack or~     stroke in African American patients with a history of unstable angina or myocardial~     infarction.~   "
244549|NCT00353054|"~     The aim of this study was to assess the effect of calcium/vitamin D supplementation (Caltrate~     600 +D®) on body weight loss during a weight-reducing program~   "
244550|NCT00353041|"~     This is a study of the effect of time on the effectiveness of topical anesthetics in the~     mouth. The Null Hypothesis is: Regardless of the time of application over a 10-minute period,~     there is no difference in the clinical effectiveness of the topical anesthetic 5% lidocaine~     on (a) the pain of needle stick insertion and (b) the pain of local anaesthetic~     administration.~   "
244551|NCT00353028|"~     This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the~     treatment of children and adolescents with depression or depressive state~   "
244552|NCT00353015|"~     Primary Objective:~      1. Assess the clinical activity defined by response rate of irinotecan and cisplatin in~     untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the~     gastrointestinal tract.~      Secondary Objective:~      1. To assess the safety profile of irinotecan and cisplatin in untreated patients with~     metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.~   "
244555|NCT00352976|"~     This is a single arm, total body irradiation (TBI) trial. All patients will be prescribed TBI~     300 cGy with the goal of evaluating secondary endpoints.~   "
244561|NCT00352898|"~     Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine~     childhood practice and often co-administered during the second year of life, a combined~     measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine is fully justified. Such a combined~     vaccine was developed and extensively studied in susceptible children. In countries where~     varicella mass-vaccination is already implemented, a transition period is necessary as~     children who started with separate first-dose vaccinations of MMR and varicella will receive~     a single shot of the combined vaccine as the second dose. To account for those situations,~     this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine~     given in place of separate MMR and varicella vaccines as a second dose.~   "
244562|NCT00352885|"~     This study will determine the effectiveness of an antidepressant in preventing or reducing~     depressive symptoms in people with melanoma who are receiving Interleukin-2 (IL-2) treatment.~   "
244563|NCT00352872|"~     The goal of this pilot study is to delineate the role of genetic variations in premature~     menopause, hot flashes, and other toxicities in a cohort of premenopausal women with early~     breast cancer.~      Primary Objective- To ascertain the effect of common variant alleles of CYP450 2B6, 2C19,~     2C9, and 3A5 in pre-menopausal women with breast cancer receiving anthracycline and~     cyclophosphamide based chemotherapy as it relates to occurrence of premature menopause~     (defined as more than 12 months of amenorrhea and serum estradiol and FSH levels consistent~     with post-menopausal status)~      Secondary Objective #1- To obtain pilot data on the effect of common variant alleles of~     CYP450 2B6, 2C19, 2C9, and 3A5 in pre-menopausal women with breast cancer receiving~     anthracycline and cyclophosphamide based chemotherapy as it relates to occurrence of hot~     flash frequency, and other common toxicities of therapy requiring dose delay or reduction.~      Secondary Objective #2- To obtain pilot data on the correlation of hot flashes with serum~     levels of serotonin, tryptophan, and their metabolites and with polymorphisms of the~     serotonin transporter and receptor genes.~   "
244564|NCT00352859|"~     The purpose of this study is to see if taking interferon or gemcitabine along with sorafenib~     will stop the advanced renal cell cancer from becoming worse in some people. To do this,~     sorafenib along with gemcitabine or interferon will be compared to treatment with gemcitabine~     or interferon alone. More safety information on sorafenib will be also collected. About 260~     patients with progressed renal cell cancer will be in this study.~   "
244565|NCT00352846|"~     Primary Objective:~        -  Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total~          lumbar spine and femoral neck.~      Secondary Objectives:~        -  Evaluate the effect of zoledronate on change in BMD at the total hip~        -  Evaluate risk factors for developing osteoporosis on chemotherapy~        -  Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect~          on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with~          calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).~   "
244566|NCT00352833|"~     Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery~     alone in patients after curative resection of a gastric adenocarcinoma in order to gain more~     detailed information primary on safety, tolerability and feasibility and secondary on~     relevant efficacy parameters.~   "
244567|NCT00352820|"~     The objective of this study is to explore the experience of informal caregivers of patients~     with a primary brain tumor, identifying elements and themes of the caregiving experience~     specific to this population of caregivers. The aim is to describe the experience of being an~     informal caregiver for a patient with a primary brain tumor.~   "
244568|NCT00352807|"~     The purpose of this study is to obtain and assay human aqueous samples following~     pre-operative dosing with 0.1% Brimonidine Purite™ (pH 7.8) or with 0.15% Brimonidine Purite®~     (pH 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous~     concentration of the two formulations.Study hypothesis: The aqueous humor concentration 45~     minutes following dosing of 0.1% Brimonidine Purite™ (pH 7.8) is comparable with 0.15%~     Brimonidine Purite® (pH 7.2)~   "
244569|NCT00352794|"~     The goal of this clinical research study is to learn if lenalidomide in combination with~     prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for~     the treatment of myelofibrosis will also be studied.~   "
244570|NCT00352781|"~     Approximately 2 million Ontarians are current smokers. While smoking rates have declined over~     the past 25 years, these rates have remained constant since 2002. The rate of smoking~     cessation in Ontario has not kept up with the rest of Canada. A new strategy is necessary to~     increase the number of smokers making quit attempts and to increase the odds of quitting over~     the long term.~      The overall goal of the Stop Smoking Therapy for Ontario Patients (STOP) Study is to evaluate~     the methods and effectiveness of providing nicotine replacement therapy (NRT) to Ontario~     smokers. The study will develop an evidence-based protocol for providing NRT, provide faculty~     development on combining pharmacotherapy with behavioural interventions and will provide an~     evaluation framework to inform future coverage models.~      The goal for this phase of the STOP study is to provide faculty development on combining~     pharmacotherapy with behavioural interventions. This will be achieved by partnering with~     Public Health Units across Ontario who have established smoking cessation clinics but do not~     have the finances in place to offer NRT to their clients at a subsidized rate or free of~     charge. Cost has been shown to be a significant barrier to the access and use of NRT in~     individuals trying to quit smoking. However, combining pharmacotherapy with behavioural~     interventions may be more effective than either alone. Therefore, we hypothesize that~     providing NRT free of charge to clients enrolled in a smoking cessation clinic will be more~     effective for smoking cessation than behavioural interventions alone.~   "
244571|NCT00352768|"~     This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment~     of children and adolescents with obsessive-compulsive disorder~   "
244572|NCT00352755|"~     This study prospectively evaluates a multidisciplinary approach to patients with~     intraperitoneal carcinomatosis at Washington University. Patients with peritoneal~     carcinomatosis or pseudomyxoma peritonei will undergo debulking surgery with peritonectomy~     and placement of adhesive barrier film followed by repeated delayed intraperitoneal~     chemotherapy with 5FU with systemic oxaliplatin-based chemotherapy on a biweekly schedule. A~     retrospective review of patients treated in a similar manner at our institution showed good~     tolerance and efficacy. This formal Phase II study is planned to determine the safety,~     toxicities and survival of patients with peritoneal carcinomatosis and pseudomyxoma peritonei~     treated with this regimen.~   "
244574|NCT00352729|"~     The purpose of this study is to see if treating a donor site wound with the ACell dressing is~     as good as or better than the dressings we currently treat harvested donor sites with. This~     will be tested on consenting burn patients who require excision and grafting surgery for~     their burn wounds.~      Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less~     than the mean healing time for wounds treated with the Standard of Care dressing.~   "
244575|NCT00352716|"~     The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool~     weight, when compared to placebo, in the treatment of acute diarrhoea in children.~   "
244576|NCT00352703|"~     This is an open-label, single-arm, multicentre study conducted in Spain to estimate the~     effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days~     before the start of the conditioning regimen and for 3 consecutive days after autologous~     PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose~     conditioning chemotherapy.~   "
244577|NCT00352690|"~     This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the~     treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy~     in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and~     carboplatin will follow the completion of chemoradiation.~   "
244578|NCT00352677|"~     The purpose of this study is to determine the safety and effectiveness of INNO-406 in adult~     patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+)~     leukemias.~   "
244579|NCT00352664|"~     Primary Objective:~      1. To determine the effectiveness of donepezil as compared to placebo for the management of~     opiate-induced sedation/drowsiness in patients with stable cancer pain~      Secondary Objectives:~        1. To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and~          placebo~        2. To assess the effects of donepezil on fatigue (FACIT-Fatigue), and other symptoms~          (Anderson Symptom Assessment Scale)~        3. To assess the effects of donepezil on cognition (Symbol Digit Modalities Test)~        4. To assess the effects of donepezil on constipation (number of bowel movements)~   "
244580|NCT00352651|"~     The purpose of this study is to see if therapy with the drug pregabalin relieves pain during~     shingles compared with placebo. A placebo is an inactive substance. Pregabalin is a drug~     marketed as Lyrica™ in the United States for the treatment of seizures, diabetic neuropathy,~     and post-herpetic neuralgia. The use of pregabalin and drugs like it for the treatment of~     pain during the acute phase of shingles is experimental. Thirty four subjects will complete~     the study at the University of California, San Francisco (UCSF) Pain Clinical Research~     Center. This study is funded by Pfizer Global Research.~   "
244581|NCT00352638|"~     RATIONALE: Printed educational materials and counseling by telephone may improve colorectal~     cancer screening compliance in brothers and sisters of patients with colorectal cancer.~      PURPOSE: This randomized phase III trial is studying standard or personalized printed~     educational materials with or without telephone counseling to compare how well they work in~     increasing colorectal cancer screening compliance in brothers and sisters of patients with~     colorectal cancer.~   "
244582|NCT00352625|"~     The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain~     associated with tendonitis or bursitis of the shoulder, elbow or knee.~   "
244583|NCT00352612|"~     The purpose of this study is to help define the role of antibiotics in the treatment of~     pediatric skin infections caused by community-associated methicillin-resistant Staphylococcus~     aureus (CA-MRSA). The investigators hypothesize that treatment with cephalexin, a~     penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not~     result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is~     most often susceptible.~   "
244584|NCT00352599|"~     Neurofibromatosis type I (NF1) is a genetic disorder that affects approximately 1 in 3500~     individuals. Half of people with NF1 inherit the condition from a parent, and half have a new~     occurrence of the condition. The manifestation of NF1 is highly variable and multiple organ~     systems are typically affected. Some of the more common symptoms include benign~     neurofibromas, café au lait spots, Lisch nodules (tan spots on the iris of the eye). Some~     individuals with NF1 also exhibit more severe associated conditions, such as optic pathway~     tumors (gliomas) or bones bending or curving. Neurocognitive deficits and specific learning~     disabilities occur in approximately 30 to 50% of individuals with NF1 and are regarded by~     some observers and sufferers to be among the most troubling features of a disease. The most~     commonly reported findings are deficits in visuoperceptual ability, motor coordination,~     expressive and receptive language, and executive functioning, which requires intact~     short-term memory and attention. Patients with NF1 also show a slight depression in mean IQ~     scores compared to healthy adults without the disorder.~      While cognitive deficits are now a widely-recognized feature of Neurofibromatosis Type 1~     (NF1), the precise cause of these deficits still remain to be determined. Dr. Alcino Silva, a~     co- investigator on this study, has developed an animal model of NF1 in which mice have a~     specific mutation of the *NF1* gene. These mice are physically normal but show specific~     learning impairments. Dr. Silva's lab found that treatment with a medication called~     lovastatin, a drug typically used for high cholesterol, reversed some of the spatial deficits~     seen in these animals. Lovastatin is a medication commonly used to treat high cholesterol and~     has been proven to be relatively safe and tolerable in humans.~      The investigators are now conducting a randomized, double-blinded, placebo- controlled, trial~     of lovastatin in patients with NF1. Participants will be randomly assigned to lovastatin or~     placebo and treated for approximately 14 weeks with baseline and follow-up assessments to~     evaluate safety and any effects on neurocognitive test performance.~   "
244593|NCT00352482|"~     Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's~     ability to breathe. Currently, no medications can reverse the damage to the lungs caused by~     IPF, but individuals are encouraged to engage in moderate exercise to strengthen lung~     function. This study will evaluate the effectiveness of sildenafil at improving exercise~     tolerance and breathing difficulties in individuals with IPF.~   "
244594|NCT00352469|"~     Alcohol use disorders (AUDs) are a major problem facing our society. Their treatment is~     complex, and involves multiple behavioral and pharmacotherapy interventions. There are 3~     approved medications for AUDs, but their efficacy for AUDs that co-exist with anxiety~     disorders is unknown. This study explores the effects of the medication, sustained-release~     quetiapine fumarate (Seroquel SR) for the treatment of alcohol dependence and co-morbid~     anxiety. Primary outcome measure is the amount of alcohol used. Secondary outcome measures~     include craving for alcohol, length of sobriety from drinking and level of anxiety with~     Seroquel SR.~   "
244608|NCT00352287|"~     The purpose of the study was to determine the effects of growth hormone and an insulin~     sensitizer drug in pre-diabetic adults with excessive amounts of abdominal fat. Participants~     received a combination of two drugs: (1) recombinant human growth hormone (or its placebo)~     and (2) pioglitazone (or its placebo). We measured the abdominal fat content and blood sugar~     levels of participants before and after 40 weeks of treatment.~   "
244585|NCT00352586|"~     This study will evaluate whether the drug D-cycloserine (DCS) can improve a type of learning~     called classical conditioning, in which the brain learns to associate neutral stimuli with~     stimuli that elicit emotional or physiological responses. DCS is an antibiotic that was~     initially approved to treat tuberculosis and has been tested in clinical trials over the last~     decade for enhancing cognitive function. This protocol includes both a pilot study and a main~     study. The main study will begin after the pilot study ends.~      Healthy normal volunteers between 18 and 45 years of age may be eligible for these studies.~     Candidates will be screened with a medical and psychiatric history and a physical examination~     that includes blood and urine samples, an electrocardiogram (EKG), hearing test and startle~     test. The startle test involves recording eyeblink responses to loud noises.~      After the screening visit, those enrolled will participate in the pilot or main study, in~     which their reactions to two types of stimuli-an unpleasant, but harmless, shock to the arm~     and a mild puff of air to the eye-will be measured and recorded.~      - Pilot Study~      Session 1 - Participants will receive very brief electric shocks delivered through two~     electrodes attached to the forearm or fingers and will hear brief loud sounds that may~     startle. Geometric shapes will be presented on a computer monitor.~      Sessions 2 and 3 - The procedure is the same as in session 1, except participants will also~     be subjected to brief low-intensity tones and airpuffs to the eye.~      - Main Study~      Participants will undergo the same procedures described in the pilot study, with the~     following additions:~        -  They will have an intravenous tube placed in a vein for collecting blood during the~          test.~        -  They will take a pill each test day that contains either 100 mg DCS, 500 mg DCS, or a~          placebo (inactive substance). Subjects assigned to receive DCS will get the active drug~          on only one of the three test sessions and will be given placebo the other two sessions.~          The placebo group will receive placebo all three sessions.~      In both the pilot and main study, subjects' physiological responses to the stimuli will be~     recorded. Electrodes will be placed on two fingers (to measure sweat, or electrodermal~     activity), on the ribcage midway between the waist and armpit (to measure heart rate), and~     under one eye (to measure eye blink). Pulse will be recorded with a device attached to a~     finger, and breathing rate will be recorded with a special belt placed around the chest. At~     various times during the sessions, subjects will fill out questionnaires about their~     experience. Participants may withdraw from the study at any point.~   "
244586|NCT00352573|"~     This study will survey a random sample of 2,100 general medicine physicians in Europe and in~     the U.S. about ethical difficulties they face in their practice of medicine. The participants~     will complete a questionnaire designed to meet the following study objectives:~        -  Identify the types of ethical dilemmas physicians report that they face in their~          practice and approaches they find helpful in responding to these situations~        -  Determine what ethical support physicians would find useful in dealing with ethically~          problematic situations~        -  Explore physicians experience with 'bedside rationing', due to economic or societal~          constraints, what procedures they forgo as a result, and what criteria they use in their~          rationing decisions~        -  Explore physicians perceptions of the equity of the health care system they work in~        -  Determine what interventions directed at limiting health care costs physicians would~          find acceptable.~      Physicians in Italy, Norway, Switzerland and the United Kingdom who practice direct patient~     care for at least 20 percent of their time may enroll in this study.~      The practice of medicine sometimes involves situations where important values come into~     conflict. The refusal of life-saving treatment, the concern that telling the truth could have~     problematic consequences, acceptable ways of facing a request to die all are examples of~     dilemmas that can arise in the practice of medicine. The absence of clear-cut 'right answers'~     to questions raised by these situations have led to the development of support services, such~     as ethics consultations, to help in decision-making concerning ethical problems that arise in~     clinical settings. Information from this survey can provide input into the continuing~     development of ethics support services by establishing an evidence base regarding the ethical~     difficulties encountered by physicians and the type of support they would consider useful in~     resolving these dilemmas.~   "
244587|NCT00352560|"~     The main purpose of the study is to compare the mean AERP between treatment groups based on~     the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological~     remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to~     placebo.~   "
244588|NCT00352547|"~     This study will evaluate the effects of certain genes (MDR-1, CYP3A4, and CYP3A5) on~     metabolism of the drug sirolimus, an immune-suppressing drug given to transplant recipients~     to prevent organ rejection. Individual differences in metabolism and excretion of sirolimus~     affect the patient's response to treatment.~      Patients who have undergone kidney transplantation at the National Institute of Diabetes and~     Digestive and Kidney Diseases (NIDDK) Transplant Branch and have received sirolimus treatment~     will be enrolled in this study.~      DNA (genetic material) will be extracted from blood samples collected from transplant~     recipients to determine their MDR-1, CYP3A4, and CYP3A5 genotypes. Patient demographic~     information and data on sirolimus metabolism and excretion will be collected from the medical~     information system, NIDDK transplant database, and the patients' medical records. The data~     will be compared among patients with different genotypes (genetic constitution of an~     individual) and haplotypes (set of genes that code for different proteins but are inherited~     as a unit) to determine the effect of these gene variations on sirolimus metabolism.~      Information from this study may be applied to developing better dosing strategies, and thus,~     treatment outcomes for transplant patients receiving sirolimus.~   "
244589|NCT00352534|"~     This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without~     radiation therapy or observation only to see how well they work in treating patients~     undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs~     used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these~     treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after~     surgery, the tumor may not need additional treatment until it progresses. In this case,~     observation may be sufficient.~   "
244590|NCT00352521|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also block blood~     flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving bevacizumab together with irinotecan may kill more tumor cells. Diagnostic~     procedures, such as MRI, may help doctors predict a patient's response to treatment and help~     plan the best treatment.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with irinotecan~     works in treating patients with recurrent malignant glioma and how well MRI predicts response~     to treatment.~   "
244591|NCT00352508|"~     The supermarket industry now services many customers through online food shopping over the~     Internet. The Internet shopping process offers a novel opportunity for the modification of~     dietary patterns. The aim of this study was to evaluate the effects on consumers’ purchases~     of saturated fat of a fully automated computerised system that provided real-time, personally~     tailored advice recommending foods lower in saturated fat.~   "
244592|NCT00352495|"~     RATIONALE: Drugs used in chemotherapy, such as vinblastine and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vinblastine when~     given together with carboplatin in treating young patients with newly diagnosed or recurrent~     low-grade glioma.~   "
244595|NCT00352456|"~     This study is directed toward a better understanding of how the brain regulates emotions and~     social and antisocial behavior. It will look at the use of the orbital frontal cortex and~     amygdala of the brain. Brain changes are involved in solving conflicts and the feelings that~     such conflicts produce. Conflicts may occur with other people or with general social rules.~     The researchers' expectations are that the findings will be useful in developing therapies~     that may improve people's ability to solve social conflicts and reduce antisocial behavior.~      Adults ages 20 to 50 years of age with psychopathy and a second set of comparison adults, all~     of whom have been released from the Fairfax County Adult Detention Center, may be eligible~     for this study.~      The neurocognitive component of the study, the one pertaining to performance of various~     tasks, will involve 20 adults with psychopathy and 20 comparison adults. The neuroimaging~     component, in which a magnetic resonance imaging (MRI) scan is used, will involve 18 adults~     and 18 comparison adults. Two visits by participants will be entailed. At the first visit,~     patients will undergo the following procedures and tests:~        -  Physical examination~        -  Test of vital signs, lying and standing.~        -  Electrocardiogram.~        -  Collection of blood for chemistry and hematology.~        -  Urinalysis and liver function tests.~        -  Screen for HIV and hepatitis.~        -  Pregnancy test, if applicable, at the first visit and at all further visits.~      Depending on the group to which they are assigned, at the second visit, patients will undergo~     an MRI scan or take part in a variety of computer-based tasks to measure different forms of~     thinking skills, emotional responses, and decision making. During the MRI scan, patients will~     lie still on a table that will slide into the enclosed tunnel of the MRI scanner. They will~     be asked to lie as still as possible. As the scanner takes pictures, patients will hear~     knocking or beeping sounds, and they will wear earplugs to reduce the noise. Patients will be~     able to communicate with the MRI staff at all times during the scan, and they may ask to be~     moved out of the machine at any time. While lying in the MRI scanner, patients will be asked~     to perform tasks presented via a screen. These tasks will involve looking at pictures or~     words, and patients will be asked to make decisions about the pictures. The MRI scan will~     take no more than 2 hours. In regard to the computer-based tasks that participants will~     perform, the tasks are often games presented on a computer. Via computer, or on paper, there~     may be presentations of pictures that bring about an emotion.~      There will be no direct treatment or therapeutic benefits to participation in this study.~     However, the knowledge gained may help people in the future.~   "
244596|NCT00352443|"~     RATIONALE: Lapatinib and everolimus may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Everolimus may also stop the growth of cancer cells by~     blocking blood flow to the cancer. Giving lapatinib together with everolimus may kill more~     cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and~     everolimus in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.~   "
244597|NCT00352430|"~     This study will evaluate new treatments for people who have pulmonary hypertension, or high~     blood pressure in the lungs, caused by sickle cell anemia or thalassemia.~      Patients ages 18 and older with a diagnosis of sickle cell disease or thalassemia, who have~     mild to severe pulmonary hypertension, and who are not pregnant or breastfeeding may be~     eligible for this study. There are three stages in the study, with up to 200 participants in~     the screening. Patients will undergo pulmonary function tests, including those for asthma and~     measurement of oxygen levels in the arterial blood. They will have a chest X-ray, computed~     tomography (CT) scan of the lungs, ventilation perfusion lung scan to look for blood clots,~     echocardiogram, test to measure how far patients can walk in 6 minutes, nighttime oxygen~     measurement done while asleep, blood collection, magnetic resonance imaging (MRI) scan of the~     heart, and exercise test. About 3 to 4 days are needed for the tests, all of which can be~     done while patients are outpatients, except for the sleep study. For the CT scan, patients~     lie on a table while an X-ray beam takes images of the lungs and heart. The lung scan~     involves breathing of a small amount of a radioactive aerosol called Tc99m DTPA while~     pictures are taken of the lungs from various angles. Then an injection of albumin, a protein~     with a small amount of radioactivity, will be given, and more lung pictures will be taken.~     For the MRI scan, patients lie on a table that slides into a machine. A medication called~     gadolinium will be injected, to help improve images made through the scan. After the tests,~     patients will be admitted to the Clinical Center for 1 day. A small plastic catheter, or~     tube, will be placed in the vein of an arm. A longer catheter will go into a deeper vein~     (neck or leg), and a pulmonary artery catheter will be inserted to measure blood pressure in~     the blood vessels. Doctors will guide the catheter into the lung artery. Patients will be~     asked to pedal on a stationary bicycle while heart and lung pressure is measured. If~     pulmonary hypertension is present, patients will proceed to the second stage (up to 50~     participants). While the catheter is still in place, patients will wear a face mask and~     breathe nitric oxide (NO) for 20 minutes. They will take 50 mg of sildenafil by mouth, and~     pressure in the heart and lungs will be monitored for about 4 hours. They will again receive~     NO for another 20 minutes. Blood samples will be taken, and the heart rhythm and pressure in~     the lungs will be monitored. Sildenafil can cause headache, flushing, and indigestion. Side~     effects of the lung scan involve allergic reactions to DTPA and albumin. Patients with an~     allergy to eggs should not have that test.~      Up to 25 patients can enter the third stage. They will breathe NO by using a tank of gas that~     delivers it through tubes to the nose, for a period of 6 weeks. They will continue taking~     sildenafil as previously prescribed and visit the clinic every 2 to 4 weeks for an~     echocardiogram, blood tests, and 6-minute walk test. After 6 weeks, patients will have~     catheterization of the heart again to measure pressure in the heart and lungs. Then NO will~     be stopped, and pressure in the lungs will be checked to see if NO has helped lower the blood~     pressure-and to make sure that the blood pressure does not increase when medication is~     stopped. Patients whose symptoms have improved as a result of breathing NO may wish to~     continue with that therapy.~   "
244598|NCT00352417|"~     This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory~     biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy~   "
244599|NCT00352404|"~     Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial~     importance for clinical management of ulcerative colitis. We assessed the value of combined~     chromoscopy and endomicroscopy for diagnosis of intraepithelial neoplasias in a randomised~     controlled trial.~      Endomicroscopy is a new device which enables microscopy of the mucosal layer during ongoing~     colonoscopy. Chromoscopy means topical staining of mucosal surface to unmask areas of~     interest, which are subsequently examined with the endomicroscopic system.~   "
244600|NCT00352391|"~     The goal of this research study is to look at how long individuals who have been treated for~     early stage NSCLC or HNSCC live without developing lung cancer. Another goal is to develop~     tools to help predict the likelihood of lung cancer occurrence in this population. This will~     be done by studying characteristics of tissue and bodily fluids (including blood).~      Objectives:~        -  To assess the smoking-related disease-free survival in patients who are current or~          former smokers with a prior definitively-treated stage I/II lung or head and neck~          cancer.~        -  To develop a risk model to help predict the likelihood of lung cancer development both~          imaging and biomarker based in this high-risk population.~   "
244601|NCT00352378|"~     This is an open labeled phase III randomized trial. The patients with clinical stage II and~     III will undergo mammotome biopsy of breast tumor for histologic diagnosis,~     immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu~     and others. PET results will determine the positivity of lymph node metastasis.~   "
244602|NCT00352365|"~     This phase II trial is studying how well lenalidomide works in treating older patients with~     acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as~     lenalidomide, may stimulate the immune system in different ways and stop cancer cells from~     growing.~   "
244603|NCT00352352|"~     This is a study of the efficacy of acupuncture in children with autism.~   "
244604|NCT00352339|"~     Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate~     the same efficacy as compared to risperidone continuation treatment in the treatment of~     schizophrenia.~   "
244605|NCT00352326|"~     For children who depend on devices to communicate, the rate of communication is a primary~     determinant of success. For children with motor impairments, the rate of communication may be~     limited by inability to contact buttons or cells rapidly or accurately. It is therefore~     essential to know how to adjust the device interface in order to maximize each child's rate~     of communication. The optimal rate of communication is determined by the Channel Capacity,~     which is the maximum value of the Information Rate for all possible keyboard button or cell~     layouts for the communication device. We construct a mathematical model for the information~     rate based on the relationship between movement time and the number of buttons per screen,~     the size of the buttons, and the length of a sequence of buttons that must be pressed to~     communicate each word in the vocabulary. We measure the parameters of the model using a~     custom-programmed touch-screen interface.~   "
244606|NCT00352313|"~     RATIONALE: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor.~     Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving ATN-161~     together with carboplatin may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of ATN-161 when~     given together with carboplatin and to see how well they work in treating patients with~     recurrent malignant glioma.~   "
244607|NCT00352300|"~     This phase I trial is studying the side effects of giving carboplatin and paclitaxel together~     with pegfilgrastim in treating patients with stage III or stage IV ovarian epithelial,~     fallopian tube, primary peritoneal, or carcinosarcoma cancer. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Colony-stimulating factors,~     such as pegfilgrastim, may increase the number of immune cells found in bone marrow or~     peripheral blood and may help the immune system recover from the side effects of~     chemotherapy. Giving carboplatin and paclitaxel together with pegfilgrastim after surgery may~     kill any tumor cells that remain after surgery.~   "
244611|NCT00352235|"~     Phase I/II trial of KRN7000 in patients with chronic hepatitis C.~      Study objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of~     a-GalCer.~      The primary efficacy parameter: HCV-RNA response at the end of treatment. Secondary efficacy~     parameter: Serum ALT response. Further objectives of the study are to evaluate the effect of~     a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.~      Number of dose levels: 3 Investigational product: KRN7000 Route of administration:~     intravenous Dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day~     28 and day 56)~   "
244612|NCT00352222|"~     To obtain additional data on safety and efficacy of the Express stent implantation in the~     treatment of stenosed or occlusive atherosclerotic disease (de novo or restenotic lesions) in~     the iliac arteries (common or external).~   "
244613|NCT00352209|"~     This study will examine the incidence of cardiac complications, particularly cardiomyopathy,~     in patients who have undergone allogeneic (donor) stem cell transplantation at NIH. Cardiac~     complications in these patients are well documented. Most commonly, patients develop~     congestive heart failure or pericarditis after receiving high-dose cyclophosphamide,~     radiation, or other intensive chemotherapy regimens prior to the transplant.~      Most data in the medical literature suggest that the rate of serious cardiac complications is~     relatively low, at about 5 percent or less. Recently, a cluster of cases of significant~     cardiomyopathy in stem cell transplant patients at the NIH Clinical Center has prompted~     concern that the incidence of these complications is higher than that reported in the medical~     literature.~      This study will further define the incidence of cardiac problems, primarily focusing on~     cardiomyopathy, with the following objectives:~        -  To define the incidence of cardiomyopathy in allogeneic stem cell transplant patients~          enrolled in National Cancer Institute (NCI) and National Heart, Lung, and Blood (NHLBI)~          protocols at the NIH Clinical Center~        -  To document the presence or absence of various known or suspected risk factors for~          cardiomyopathy in the documented cases.~      The study consists of a chart review of patients who have had an allogeneic stem cell~     transplant on either an NHLBI or NCI protocol since 1999.~      This project is a first step in clarifying the cardiac complications following stem cell~     transplantation, their incidence, and characteristics of the patient populations. It will~     look at patient demographics, the characteristics of the cardiac complication, and known or~     suspected risk factors.~   "
244614|NCT00352196|"~     This study will be an open-label, 12-week trial of risperidone in subjects with Asperger's~     Disorder, according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)~     Criteria. The study has two arms, one involving pre- and post-treatment MRS studies, and one~     without MRS. The MRS arm will study 18-20 subjects ages 6 and above, with a target of 14~     completing patients. For both arms, we plan to a enroll at total of 30 patients to achieve~     completion for 24 patients. The non-MRS arm of the study will include subjects 6-18 years of~     age, the bulk of which have completed the study as of the writing of this updated revision.~     Our hypotheses are that treatment of Asperger's patients with a low dose of risperidone will:~        1. decrease ratios of N-acetylaspartate (NAA), creatine, phosphocreatine (Cr + PCr), and~          choline in the prefrontal lobe, and~        2. decrease the severity of negative symptoms and overall improve social behavior, and~        3. that the two will be correlated.~      Specific Aims~      The primary objectives of this trial are to:~        -  Further assess and investigate the utility of risperidone in the treatment Asperger's~          disorder.~        -  Assess the efficacy of risperidone in normalizing increased frontal lobe metabolites.~        -  Assess the efficacy of risperidone in normalizing symptoms in Asperger's disorder~          patients using standardized rating scales to assess the impact on negative symptoms and~          on social interaction.~        -  Determine whether risperidone's effect on clinical improvement of Asperger's disorder,~          i.e., negative symptoms, is correlated with normalization of frontal lobe metabolites~        -  Accrue safety and tolerability data on risperidone for this population of patients.~      This information could potentially be used to provide pilot data for a double blind trial~   "
244615|NCT00352183|"~     Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both~     hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary~     mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall~     objective of the study is to evaluate the efficacy and safety of combining fenofibrate and~     simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.~   "
244616|NCT00352170|"~     This study is designed to test whether calcium supplementation alone or calcium plus vitamin~     D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts~     bone loss in a population-based sample of women 55+ years of age.~        -  A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of~          spine and appendicular fractures over four years for independently living, rural women~          55 years of age and older compared to similar women on their usual diets.~        -  A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the~          cumulative incidence of spine and appendicular fractures compared to a calcium~          supplement only.~   "
244617|NCT00352157|"~     The purpose of this study is to determine if dietary consumption of Revival Soy can improve~     the appearance of the skin, hair, and finger nails and support weight loss in overweight,~     premenopausal women.~   "
244618|NCT00352144|"~     To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects~     with primary insomnia on subjective sleep measures, compared to placebo.~   "
244619|NCT00352131|"~     RATIONALE: Monoclonal antibodies, such as maytansinoid DM4-conjugated humanized monoclonal~     antibody huC242, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them.~      PURPOSE: This phase I trial is studying the side effects and best dose of maytansinoid~     DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors~     that cannot be removed by surgery or have spread to other parts of the body.~   "
244635|NCT00351910|"~     To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in~     combination with an antidepressant versus an antidepressant alone in patients with Major~     Depressive Disorder.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
244636|NCT00351897|"~     The purpose of this study is to determine whether Pulsed Dye Laser therapy are effective in~     the treatment of Cutaneous Dermatophytosis.~   "
244620|NCT00352118|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving combination chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with radiation therapy works in treating patients with locally advanced head and neck cancer.~     The doctor also wants to find out if patients who receive this treatment need a feeding tube~     1 year after starting treatment.~   "
244621|NCT00352105|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor~     cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin,~     fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how~     well they work in treating patients with locally advanced head and neck cancer.~   "
244622|NCT00352092|"~     The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and~     calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney~     transplant from a living donor that is HLA-identical (has a similar immune system).~   "
244623|NCT00352079|"~     RATIONALE: Biological therapies, such as BCG, may stimulate the immune system in different~     ways and stop tumor cells from growing. Gefitinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving BCG together with gefitinib may~     kill more tumor cells. It is not yet known whether BCG is more effective with or without~     gefitinib in treating bladder cancer.~      PURPOSE: This randomized phase III trial is studying BCG and gefitinib to see how well they~     work compared to BCG alone in treating patients with high-risk bladder cancer.~   "
244624|NCT00352066|"~     The aim of the study is to see if apricitabine or tipranavir affect the levels of each other~     in the blood (pharmacokinetic interaction) when they are dosed together.~   "
244625|NCT00352053|"~     The purpose of this study is to assess the safety and efficacy of tenofovir disoproxil~     fumarate (tenofovir DF; TDF) plus a genotype-guided optimized background regimen (OBR)~     compared to placebo plus OBR in the treatment of human immunodeficiency virus type 1 (HIV-1)~     infected antiretroviral treatment-experienced adolescents with plasma HIV-1 ribonucleic acid~     (RNA) levels greater than or equal to 1000 copies/mL.~   "
244626|NCT00352027|"~     The main purpose of this protocol is to estimate the percentage of patients with intermediate~     risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years~     after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field~     radiation therapy. The hypothesis being studied is that this treatment will result in more~     than 80% of patients being alive and free of disease three years after starting treatment.~   "
244627|NCT00352014|"~     The purpose of this study is to investigate whether the level of Platelet Inhibition as~     assessed with five point-of-care platelet function assays correlates with clinical~     (periprocedural) outcomes such as Acute Myocardial Infarction, death, Target Vessel~     revascularization and/or stroke in patients undergoing elective PCI.~   "
244628|NCT00352001|"~     RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the~     cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer~     cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Azacitidine may also cause cancer cells to look more like normal cells, and to grow~     and spread more slowly. Giving lenalidomide together with azacitidine may kill more cancer~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide and~     azacitidine in treating patients with advanced myelodysplastic syndromes.~   "
244629|NCT00351988|"~     The primary objectives are to:~      1.1 identify and compare the experiences of minority and nonminority caregivers, including~     the prevalence and severity of physical (fatigue, sleep disturbance) and psychologic~     (depression, anxiety, stress) symptoms and their influence on caregiver symptom burden; and~     to~      1.2 assess the relationship between caregiver's symptoms (physical and psychologic) and the~     patient's symptom's at multiple time points over the patient's treatment regimen for advanced~     solid tumors (lung, breast, cervical, and others).~      A secondary objective is to:~      1.3 describe the experience of being a minority (African American/Black or Latino) or~     nonminority person caring for a medically underserved patient with advanced solids tumors~     (lung, breast, cervical, or others) over the course of the patient's treatment regimen and~     follow-up clinic visits.~   "
244630|NCT00351975|"~     This phase I trial is studying the side effects and best dose of belinostat when given~     together with azacitidine in treating patients with advanced hematologic cancers or other~     diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,~     such as azacitidine, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving belinostat together with~     azacitidine may kill more cancer cells.~   "
244631|NCT00351962|"~     Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated~     stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10~     treatments.~   "
244632|NCT00351949|"~     Single-center, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in~     ambulatory and day-hospital setting~   "
244633|NCT00351936|"~     This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of~     the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated~     patients with schizophrenia or schizoaffective disorder. The advantage of the crossover~     design is that each subject will act as their own control and fewer subjects will be required~     than a between-group design.~   "
244634|NCT00351923|"~     This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered~     subcutaneously or using an alternative administration route.~   "
244637|NCT00351884|"~     Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy~     on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in~     patients with type 2 diabetes inadequately controlled with metformin.~   "
244638|NCT00351871|"~     The objective of this study is to better understand the influence of insulin resistance upon~     treatment response in hepatitis C virus treated with PEG Intron and Rebetol.~   "
244639|NCT00351858|"~     The purpose of this study is to determine the safety and efficacy of the investigational~     trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy~     refractory Her-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer~   "
244640|NCT00351845|"~     The purpose of this study is to test the effects of a modified carbohydrate diet versus a~     portion controlled diet in overweight or obese men and women on body weight.~   "
244641|NCT00351832|"~     This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic~     agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg~     bid or 100mg qd compared to placebo in patients with type 2 diabetes.~   "
244642|NCT00351819|"~     Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the~     synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis~     by the testes. Similarly, men with addiction to narcotics and those on exogenous opioids for~     pain control have decreased serum testosterone levels. Indeed, these men complain of~     decreased libido, erectile dysfunction and impaired quality of life. Animal studies have~     shown that gonadectomy results in a decrease in pain threshold in rats and repletion of~     testosterone elevates that threshold. These observations suggest that testosterone may~     possess analgesic properties. Hence, the investigators hypothesize that hypogonadism~     developing in men on opioids results in an increased sensitivity to pain and requirement of~     higher doses of opioids. In this study, the investigators plan to administer testosterone to~     men with opioid-induced hypogonadism and evaluate their pain perception, pain sensitivity in~     response to noxious stimuli and changes in the requirement of opioids in response to~     testosterone administration.~      Hypothesis:~      Testosterone replacement in men with opioid-induced hypogonadism will improve pain tolerance,~     pain perception and quality of life.~      Specific aims:~        1. To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance,~          and pain modulation in men with opioid-induced hypogonadism.~        2. To determine the effects of testosterone replacement on health-related quality of life.~        3. To determine whether testosterone replacement in hypogonadal men induces changes in the~          dosage requirements of opioid medications for pain control.~      To accomplish our specific aims, the investigators propose a randomized, double blind,~     placebo-controlled, parallel arm study in which hypogonadal men with non-cancer chronic back~     pain syndrome on chronic opioids and low testosterone levels (<300 ng/dl) will be randomized~     to exogenous testosterone replacement therapy vs placebo. Our primary outcome is change in~     pain tolerance using various external painful stimuli. Secondary outcomes are change in pain~     sensitivity and modulation, quality of life and opioid requirements.~   "
244643|NCT00351806|"~     The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able~     to improve the outcome of acute ischemic stroke and to observe its safety.~   "
244644|NCT00351793|"~     The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized~     Total Knee Replacement.~   "
244645|NCT00351780|"~     Study purpose: To evaluate fractional flow reserve-guided side branch intervention strategy~     Method: Provisional side branch intervention if jailed side branch FFR<0.75~   "
244646|NCT00351767|"~     This is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety~     and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years~     old with diabetic foot ulcers. Approximately 160 adult subjects with Type 1 or Type 2~     diabetes mellitus will be enrolled at approximately 40 investigational sites in the United~     States and Canada.~   "
244647|NCT00351754|"~     To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector~     CTA~   "
244648|NCT00351741|"~     The purpose of this study is to compare High Frequency Pressure Ventilation (HFPV) to~     conventional mechanical ventilation.~      Hypothesis: Patients placed on HFPV will have significantly higher number of ventilator-free~     days compared to patients placed on a conventional volume mode.~   "
244649|NCT00351728|"~     Patients diagnosed with ocular melanoma consent to participate in the study. Combined PET/CT~     scans of the whole body are performed at baseline, three months later, and six months after~     that for a total of three combined scans in the first year. Subsequently, these combined~     scans will be performed at 6-monthly intervals for a total of two combined scans per year.~   "
244650|NCT00351715|"~     The purpose of this Phase II study is to determine the feasibility of the dose titration and~     assessment protocol in the outpatient population before conducting an appropriately powered~     phase III study. Thus the primary purpose of this study is to determine the proportion of~     patients who are successfully titrated to an optimal dose of sublingual (Under the tongue)~     methadone and then studied at that optimal dose with successive episodes of breakthrough~     pain.~   "
244651|NCT00351702|"~     Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis~     in HIV infected persons~      Phase: Phase III trial~      Population: 650 HIV positive patients without tuberculosis~      Number of sites: Three~        1. Tuberculosis Research centre, Chennai~        2. Government General Hospital, Chennai~        3. Government Rajaji Hospital, Madurai~      Study Duration: 36 months~      Study Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing~     the incidence of tuberculosis and mortality among HIV-infected persons~      Study Design:~      The study will be a two-armed prospective randomized clinical trial among HIV- positive~     patients without active tuberculosis. Enrolled patients will be assigned to one of the two~     unsupervised self-administered treatment regimens i.e. EH for 6 months or INH alone for 3~     years. At the end of a 3-year follow-up, incidence of TB and overall mortality will be~     compared in each group.~      Study Endpoints:The primary end point of the study will be development of tuberculosis and~     the secondary endpoints will include adverse drug reactions and mortality rate.~   "
244652|NCT00351689|"~     A probiotic bacterial strain was tested in a randomized, double blind , placebo controlled~     clinical trial with 54 healthy male volunteers. Half the volunteers received the dietary~     supplement the other half placebo during 6 weeks prior to exposure to solar-simulated UV~     irradition (2x1,5MED). Blister roofs and skin biopsies were recovered 1, 4 and 10 days after~     UV exposure from unirradiated and irradiated skin and used for immunohistochemical analysis~     and mixed epidermal cell lymphocyte reaction~   "
244676|NCT00351377|"~     Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in~     gastrointestinal (GI) complications in some patients. This study will 1) determine the~     proportion of patients with autoimmune diseases who are experiencing any GI complaints under~     MMF-based immunosuppressive treatment and 2) assess if a switch from MMF to enteric-coated~     mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life~     outcomes.~   "
244653|NCT00351676|"~     We, the researchers, propose to link a clinical pharmacist with an internal medicine or~     family medicine team to provide pharmaceutical care to all patients assigned to the team. The~     hypothesis is that through this team based approach, pharmacists will act as a resource for~     providing pharmacotherapeutic advice during the drug therapy decision making process and~     promote optimal drug use by identifying and resolving actual and potential drug related~     problems. This study is designed to test this hypothesis, by assessing the impact of this~     intervention on evidence based, quality of drug therapy indicators, for patients admitted~     with heart failure (HF), chronic obstructive pulmonary disease (COPD), community acquired~     pneumonia (CAP), type 2 diabetes mellitus (T2DM), and stable coronary artery disease (CAD).~   "
244654|NCT00351663|"~     The purpose of this study is to evaluate the efficacy of 3 different dosing regimens of~     enoxaparin in achieving adequate antithrombotic aFXa levels in critically ill patients.~      The relationship between appearance of DVT and antithrombotic aFXa levels will also be~     assessed and risk factors associated with inadequate aFXa levels under standard enoxaparin~     dosages will be searched for.~   "
244655|NCT00351650|"~     This study will test dihydrotetrabenazine, or 11C-DTBZ, a radioactive tracer, as an imaging~     agent in positron emission tomography (PET). That tracer may have the ability to~     noninvasively measure beta cell, that is, -cell mass (BCM) in humans. For researchers hoping~     to develop new treatments for diabetes mellitus, a method of measuring BCM is very important.~     In this study, researchers will determine if patients with Type 1 diabetes mellitus, who have~     almost no BCM, have much less pancreatic uptake of the tracer than do patients without~     diabetes. Patients ages 18 and older may be eligible for this study. Three groups will be~     studied: Participants who have Type 1 diabetes, those without diabetes, and those who have~     been successfully treated with a transplant of the pancreas or pancreas and kidney~      The study involves three sets of tests that can be done as an outpatient or after being~     admitted to the hospital. Patients will undergo a medical history and procedures including~     collection of blood (about 4 teaspoons), pregnancy test for women of childbearing age,~     magnetic resonance imaging (MRI) scan, PET scan, and tests involving arginine and glucose.~     Arginine is a substance that stimulates insulin release from the -cells. During the~     procedure, two intravenous (IV) lines are placed into the arms, one to administer arginine~     and the other to draw blood (about eight samples during 10 minutes). For the glucose test,~     patients will drink a solution of dextrose, a sugar, and blood samples will be taken over 2~     hours from the IV lines. Some patients experience nausea after drinking the solution. Within~     48 hours of either test or both, patients will be placed in the PET scan machine and given an~     injection of the radioactive material through an IV line. Blood samples of about one-half~     teaspoon will be drawn before the procedure starts and again every 10 seconds for the first 2~     minutes and at several intervals, up to 60 minutes. Finally, patients will also an MRI scan,~     30 to 60 minutes long, of the abdomen. This test will be down within two weeks of the PET~     scan. MRI uses a strong magnetic field and radio waves to obtain images of body organs and~     tissues. During the scan, patients will be asked to lie still on a table that slides into the~     tunnel of the scanner. They will be given earplugs, for the machine can be noisy. Patients~     who have metal within their body that is not compatible with the MRI machine will be~     withdrawn from the study.~   "
244656|NCT00351637|"~     The purpose of this Phase II study is to determine the feasibility of the dose titration and~     assessment protocol in the impatient population, in the clinical setting of preventing or~     managing breakthrough pain, before conducting an appropriately powered phase III study. Thus~     the primary purpose of this study is to determine the proportion of patients who are~     successfully titrated to an effective dose of sublingual methadone.~   "
244657|NCT00351624|"~     The primary objective of this study is to determine whether a 4-month period of~     supplementation with 400 mg/day of docosahexaenoic acid (DHA) provided from chewable softgel~     capsules containing bubblegum flavored microalgal oil (DHASCO-S) versus placebo improves one~     or more cognitive measures of attention, memory, processing speed, and error rate in healthy~     children 4 years of age.~      The secondary objectives are to measure the safety and tolerability of the DHA dose~     administered and to measure blood DHA levels before and after supplementation.~   "
244658|NCT00351611|"~     Patients with partial seizures currently taking 1-3 antiepileptic medications will have a~     50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to~     their current medications for 3 months. Neither the study doctor nor the patient will know~     the medication assignment. Vision testing will be performed prior to receiving the study~     treatment and at the end of the study to see if there are any changes.~   "
244659|NCT00351598|"~     The main aim is to determine, in patients with locoregional, non-small cell lung cancer~     (NSCLC) treated by definitive radiotherapy, the influence on survival of the volume of~     primary tumour, as measured from CT imaging, after adjusting for the effect of the current~     TNM staging system and other known prognostic factors (especially ECOG performance and weight~     loss).~   "
244660|NCT00351585|"~     Type 2 diabetes results when the body does not produce enough insulin to regulate blood~     sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin~     secretion by the pancreas.~   "
244661|NCT00351572|"~     This study will determine whether a new diagnostic test called the Cell Search Assay can~     detect circulating colon cancer cells in patients who have had surgery for colon cancer and~     had visible cancer removed. Other parts of the study will look at whether the presence of the~     circulating tumor cells in blood predicts whether a patient will have their colon cancer~     return.~   "
244662|NCT00351559|"~     This study is designed to evaluate the safety and efficacy of a leukocyte gene expression~     profiling method in the monitoring of asymptomatic heart transplant patients for acute~     rejection.~   "
244663|NCT00351546|"~     Type 2 diabetes results when the body does not produce enough insulin and/or is unable to~     properly use the insulin it makes (insulin resistance). This study was undertaken to assess~     the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.~   "
244664|NCT00351533|"~     The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids)~     given enterally is safe and effective in reducing lung and systemic inflammation seen in~     acute lung injury.~   "
244677|NCT00351364|"~     To evaluate the effect of the drug Montelukast on the brachial artery's function. By giving a~     drug like Montelukast, which blocks the effects of inflammation in the lungs arteries and~     controls asthma, we hope to see positive effects in other arteries such as in the heart.~   "
244695|NCT00351130|"~     Essential hypertension is a widespread disease which affects one out of every three adults in~     the industrialized world. It contributes to cardiovascular disease development, a major and~     well established risk factor. A patient non compliant to drug therapy is recognized as one of~     the primary reasons for inadequate blood pressure control.~   "
244719|NCT00350818|"~     Primary Objective:~      -To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance~     treatment after allogeneic transplantation for high-risk AML / MDS.~      Secondary Objective:~      -To assess the effect of treatment on survival after allogeneic transplantation for high-risk~     AML / MDS.~   "
244665|NCT00351520|"~     Cutaneous leishmaniasis is a parasitic skin lesion caused by different species of Leishmania~     and transmitted by the bite of infected sand flies. Leishmaniasis is exist in 88 countries,~     pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a~     standard treatment for this disease for last 80 years. Pentavalent antimonials are only~     available as injectable, which is painful, toxic, not affordable and moreover is not always~     effective even sometimes with several courses of treatment. Many different modalities are~     used to treat the disease with little success. Miltefosine is drug and has recently been~     shown to be effective in the treatment cutaneous leishmaniasis in Colombia. The molecular~     mechanisms that contribute to this effectiveness are not clearly understood. Only a well~     designed, randomized clinical trial can precisely evaluate the efficacy of any therapeutic~     modalities in cutaneous leishmaniasis. In this study the efficacy of oral treatment of~     miltefosine 2.5 mg per Kg body weight for 4 weeks will be compared with standard treatment of~     intramuscular injections of 60 mg/kg/day glucantime for 2 weeks in ACL parasitologically~     proven patients. At 8 weeks after the initiation of the treatment any patient in the group~     who received miltefosine and has not responded to the treatment will be treated with the~     standard intramuscular injections of 60 mg/kg/day glucantime for 2 weeks. The clinical trial~     will be carried out according to the International approved GCP (Good Clinical Practice)~     guide lines.~   "
244666|NCT00351507|"~     This study was designed to directly assess the effects of vildagliptin on gastric emptying in~     people with type 2 diabetes.~   "
244667|NCT00351494|"~     Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as~     improve the follow-up after specific treatments like embolization. It will also help the~     investigators better understand the mechanism of success or failure for embolization and~     could reduce the amount of particles injected by determining the endpoint of the procedure in~     order to treat the myomas while preserving the myometrium.~   "
244668|NCT00351481|"~     We will investigate maternal and embryonic factors in women with recurrent implantation~     failure, undergoing IVF/ ICSI treatment. Women who have not achieved a pregnancy after three~     embryo transfer procedures will undergo an endometrial biopsy during the window of~     implantation in a natural cycle. During the next treatment cycle we will aspirate endometrial~     secretion and perform a doppler ultrasound investigation of the a. uterina. Moreover, we will~     investigate the cytokine expression from the transferred embryo from the culture medium.~   "
244669|NCT00351468|"~     An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of~     eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who~     have previously been enrolled in an eltrombopag trial. This study will allow adjustment of~     the eltrombopag dose to achieve an individualized dose and schedule for each subject. In~     addition, the ability to reduce the dose of concomitant ITP medications in the presence of~     eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.~   "
244670|NCT00351455|"~     This study is being conducted to gain a better understanding of the quality of life for~     patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to~     have surgery to repair the hernia or 2) patients who cannot have surgery because their health~     will not allow them or 3O if surgery to repair the hernia is completed. A comparison will be~     made between those who receive surgery and those who do not.~   "
244671|NCT00351442|"~     Some people who are exposed to the HIV-1 virus are capable of either controlling or~     completely preventing viral infection. Multiple genetic factors may contribute to preventing~     or controlling HIV-1 infection. The purpose of this study is to analyze the immune system~     responses of individuals who are exposed to HIV-1 but remain uninfected.~   "
244672|NCT00351429|"~     To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical~     procedures~   "
244673|NCT00351416|"~     This research study involves the use of the drugs Letrozole, GnRH, and NAL-GLU GnRH~     antagonist. Letrozole is a drug that is approved by the U.S. Food and Drug Administration~     (FDA) for use in breast cancer treatment that has been found to block the formation of~     estrogen. The NAL-GLU GnRH antagonist is a drug that temporarily blocks the action of GnRH.~     GnRH is a hormone that the body makes that stimulates other hormones that then control the~     function of the ovary.~      The purpose is to study the effects of the administration of letrozole in women with GnRH~     deficiency at the same time that they receive gonadotropin-releasing hormone (GnRH). In~     addition, administration of letrozole and NAL-GLU GnRH antagonist in healthy women with~     normal menstrual cycles will be done to evaluate the role of estrogen in the control of the~     hormone FSH, or Follicle Stimulating Hormone, in the female reproductive cycle. A better~     understanding of FSH control may help in the development of new treatments for women with~     difficulty conceiving.~   "
244674|NCT00351403|"~     Patients with chronic hepatitis C genotype 1 virus infection are usually treated with~     Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for~     others too short. An individually adapted therapy length from 24 to 72 weeks will be~     determined in dependence of the initial virus load and the time to HCV RNA negativity.~      The primary objective is to compare the cumulative rate of the sustained viral response (SVR)~     of the patients with the individually adapted therapy duration to the SVR rates of a historic~     patient collective under the 48 week standard therapy.~   "
244675|NCT00351390|"~     Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from~     the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such~     as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta~     blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in~     parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels~     may identify a patient at high risk for adverse outcome from their HF, even in periods of~     apparent stability.~      It remains unclear, however, whether treating patients based on their NT-proBNP~     concentrations would be associated with better outcomes compared to standard HF therapy~     without measurement of NT-proBNP values.~      The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and~     recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to~     standard HF therapy without such 'hormone guided' treatment.~   "
244750|NCT00350389|"~     The purpose of this study is to determine whether the provision of supplementary plain~     distance glasses for outdoor use to older users multifocal glasses will reduce falls rates~     over a 12 month period.~   "
244678|NCT00351351|"~     Percutaneous nephrolithotomy (PNL), in conjunction with intracorporeal lithotripsy, allows~     for the rapid removal of any kidney stone regardless of size. Currently, the choice of~     intracorporeal lithotripters includes ultrasonic, pneumatic, and combined~     ultrasonic/pneumatic energy sources. Recently, a novel dual probe design as been introduced~     by Cybersonics of Erie, Pennsylvania. This dual probe intracorporeal lithotrite is called the~     Cyberwand, and is composed of a fixed inner probe vibrating at an ultrasonic frequency with~     an outer probe vibrating at about 1,000 Hz. As this new design has the potential to~     revolutionize intracorporeal lithotripsy, we intend to compare this novel technology to~     currently available lithotripsy technology in a randomized clinical trial.~   "
244679|NCT00351338|"~     Although morbidly obese subjects have larger than regular caloric intake, there is evidence~     that they suffer from nutritional deficiencies at a higher rate than the general population,~     probably because they eat mostly unhealthy food.~   "
244680|NCT00351325|"~     The purpose of this study is to assess the safety and tolerability of multiple escalating~     doses of BMS-663513 when given in combination with paclitaxel and carboplatin.~   "
244681|NCT00351312|"~     Evaluation of the ability of socks weaved with pressure relieving areas to reduce the~     pressure on the foot when weight bearing.~   "
244682|NCT00351299|"~     The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect -~     a sedative) is effective for the treatment of acute delirium~   "
244683|NCT00351286|"~     To prove the combination of L-citrulline with simvastatin leads to greater improvement in the~     symptoms of peripheral arterial disease (PAD) than simvastatin alone by evaluating oral L-~     citrulline or placebo against simvastatin for improvement in treadmill walking distance in~     patients, 40–75 years of age, who have PAD with intermittent claudication.~   "
244684|NCT00351273|"~     Reactive arthritis, also known as Reiter's syndrome, is a form of arthritis that occurs as a~     reaction to an infection elsewhere in the body. It is characterized by inflammation of the~     joints, tendons, urogenital tract, and eyes. Pain and swelling in the knees, ankles, and feet~     are common. This study will determine the effectiveness of antibiotic therapy in treating~     people with chlamydia-induced reactive arthritis that has lasted for more than 6 months.~   "
244685|NCT00351260|"~     The study aims to assess whether a SIMPLE or a COMPLEX strategy is best for the treatment of~     coronary bifurcation stenoses.~   "
244686|NCT00351247|"~     To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during~     primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct~     stenting without the postconditioning.~   "
244687|NCT00351234|"~     The purpose of this study is to determine whether type I diabetics with carnitine deficiency~     exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized~     hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to~     have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those~     subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour~     glucose monitoring.~   "
244688|NCT00351221|"~     The trial will investigate the treatment of growth failure in children with Noonan syndrome.~     Abnormalities in the growth hormone (GH) – insulin-like growth factor-I (IGF-I) axis~     resulting in low IGF-I levels have been suggested as a possible cause of short stature seen~     in Noonan syndrome children. Administration of our investigational product is intended to~     bypass the abnormalities in the GH-IGF axis, and hopefully improve body growth.~   "
244689|NCT00351208|"~     The purpose of the study is to measure the efficacy of varying spinal cord stimulation~     frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator~     settings that are most effective in chronic pain management hope to be revealed for the~     purposes of this study. In this double-blind study, both the patient and the staff will not~     be aware of the spinal cord stimulator settings for each patient each week. The~     representative that will set the settings each week will be blinded to the identity of each~     patient and will set the spinal cord stimulator from another room. While there are few papers~     that show the efficacy of spinal cord stimulation in treating chronic pain, there has yet to~     be a study performed that measures the role of stimulation frequency and pulse-widths. This~     study hopes to be the first.~   "
244690|NCT00351195|"~     Various cytotoxic agents have been evaluated in advanced hepatocellular carcinoma, but~     response rates have been low with significant toxicity, most often due to parenchymal liver~     disease. The three agents etoposide, oxaliplatin and capecitabine each has sparse efficacy as~     single agents, but the combination may act synergistically with an acceptable toxicity~     profile.~   "
244691|NCT00351182|"~     New antibiotics are required that have antibacterial activity against doxycyline resistant O.~     tsutsugamushi, that can be safely used in pregnant women and children, that have a low~     possibility of inducing resistance and that do not induce cross resistant to other~     antibiotics. Telithromycin has been reported to be effective on Rickettsia, Batonella and~     Coxiella burnetii. Therefore, telithromycin may be considered as a substitute antibiotic that~     can be used safely in pregnant women and children for rickettsiosis or Orientia infection.~     Our study was designed to prove the clinical usefulness of telithromycin by comparing it with~     doxycycline for treating mild or moderate scrub typhus.~   "
244692|NCT00351169|"~     To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in~     the treatment of Major Depressive Disorder.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
244693|NCT00351156|"~     The purpose of this study is to learn more about Gaucher disease. The information we collect~     from medical histories and a blood sample from people with Gaucher disease may help us~     pinpoint certain things that are different between people who have Gaucher disease and people~     who do not have Gaucher disease. This information may be useful in the future to help find~     new treatments for Gaucher disease.~   "
244694|NCT00351143|"~     This study will investigate whether study subjects with previously uncontrolled asthma~     treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of~     Total Control of their condition and whether adherence to treatment can be enhanced by~     teaching the subjects. Two groups of equal size with identical medical treatment will be~     compared with each other, the test group receiving three training modules during study visits~     and the control group regular study visits only.~   "
244696|NCT00351117|"~     This trial will test the efficacy of St. John's Wort (SJW) as a supplement, in the treatment~     of Raynaud's phenomenon (RP). The investigators are hypothesizing that taking SJW 300mg, 3~     times a day will decrease the frequency, duration, and severity of RP attacks when compared~     to placebo.~      Patients with RP will answer questionnaires and self-evaluate their symptoms of RP as a~     baseline. Then they will be assigned to either a treatment (will receive SJW capsules) or~     placebo (will receive non-therapeutic capsules) group. They will be required to take their~     capsules, self-evaluate their progress and be evaluated every two weeks in a clinic. The~     treatment phase will last six weeks.~      This trial will be conducted in a way to mimic the normal usage of natural products. Patients~     will not be required to stop any current treatment for RP.~   "
244697|NCT00351104|"~     The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain~     associated with ankle sprain or strain.~   "
244698|NCT00351091|"~     The primary objective of this pilot study is to estimate the percent change from baseline at~     Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate~     administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment~     period both compared to a 5 mg daily dose of risedronate for 6 months~      The secondary objectives are :~        -  To estimate the percent change from baseline at specified visits other than Week 4,~          Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and~          the loading dose regimen of risedronate over a 6 month treatment period both compared to~          the 5 mg daily dose of risedronate.~        -  To estimate the percent change from baseline at all specified visits in serum CTX and~          bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate~          administered for 6 months and the loading dose regimen of risedronate over a 6 month~          treatment period both compared to the 5 mg daily of risedronate.~        -  To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the~          monthly 150 mg dose of risedronate administered for 6 months and the loading dose~          regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily~          dose of risedronate.~        -  To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.~   "
244699|NCT00351078|"~     In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation~     (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator~     (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF~     due to a nonsense mutation. In an ongoing Phase 2a study being performed at the Hadassah~     University Hospital - Mount Scopus in Israel, patients with nonsense-mutation-mediated CF~     have received PTC124 in two 14-day treatment courses. Preliminary results from that study~     indicate that PTC124 has pharmacodynamic activity of PTC124 in CF and that PTC124 can be~     safely administered in this patient population. This Phase 2b extension study is designed to~     evaluate the activity and safety of 3 months (approximately 84 days) of continuous treatment~     with PTC124 in the same patients who were enrolled to the Phase 2a study. The main purpose of~     this study is to understand whether PTC124 can be safely administered and achieve~     pharmacodynamic activity in patients with CF due to a nonsense mutation.~   "
244700|NCT00351065|"~     This study was designed to evaluate the efficacy and safety of the SK3530 tablet and to find~     the optimal dose and dosage schedule after oral administration to patients with erectile~     dysfunction.~   "
244701|NCT00351052|"~     This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric~     atopic dermatitis~   "
244702|NCT00351039|"~     This is a Phase I/II trial of elderly patients (> 70 years of age). Patients in this age~     group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer~     (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be~     enrolled. Therapy consists of three drugs (Premetrexed[Alimta™], Bevacizumab and~     Erlotinib[Tarceva™]) which are given every 28 days.~   "
244703|NCT00351026|"~     Treatment of opioid dependence is an important way to reduce the spread of HIV and other~     infectious diseases, particularly in Ukraine since intravenous opioid use is the major way~     these infections are being spread. This proposal will be done at the Kiev City Narcology~     Hospital and the City AIDS Center with collaborators from the University of Alabama and the~     University of Colorado. It will study the acceptability and impact of a 3-month course of~     methadone maintenance on 50 persons with opioid dependence, 25 who are HIV+ and 25 HIV-. The~     proposed work will build on a relationship that was established with the Ukrainian~     Co-Principal Investigator, Sergiy Dvoryak, M.D., during his Humphrey Fellowship at Johns~     Hopkins in 1999-2000 when he spent time with Dr. Woody and Metzger at the Penn Addiction and~     Treatment and Research Center. It will also extend studies of pharmacologic treatment for~     opioid dependence and risk reduction behavioral interventions that are being done by Drs.~     Woody, Schumacher and Booth in Russia and Ukraine. Primary aims are to: measure the~     acceptability and compliance with a 3-month course of methadone maintenance in HIV+ and HIV-~     patients; measure the impact of a 3-month course of methadone in reducing opioid use in HIV+~     and HIV- patients; measure the impact of a 3-month course of methadone on reducing HIV risk~     behavior in HIV+_and HIV- patients. Secondary aims are to: assess the degree to which a~     3-month course of methadone maintenance reduces illegal activities and improves employment~     and psychiatric symptoms; determine short-term outcome after completion of methadone~     treatment; and obtain pilot data on the prevalence of hepatitis B and C among study patients.~     This study will provide pilot data on the acceptability and efficacy of a short-term course~     of methadone maintenance on HIV+ and HIV- persons in a setting where this treatment has not~     been evaluated, on the feasibility of conducting the kind of work that is proposed, and will~     enhance research capabilities of Kiev investigators for future HIV prevention and treatment~     studies.~   "
244704|NCT00351013|"~     Malaria accounts for over 40% of outpatient morbidity in Sierra Leone. These health risks~     have been heightened further by the recent civil war, persistent poverty, lack of access to~     affordable health care, and an increasing resistance of P.falciparum parasites to the most~     commonly used therapy Chloroquine, which now has a confirmed failure rate of 39%. This study~     will recruit 780 people from the Kroo-Bay community in Freetown. Healthy subjects would be~     randomised into two subgroups and given either homeopathic pellets or placebo tablets at four~     month intervals. They are then monitored repeatedly during the study period to assess the~     efficacy of the therapy in reducing the disease burden.~   "
244705|NCT00351000|"~     This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone,~     added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients~     with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective~     disorder. The first two weeks will be a fixed-dose of ziprasidone 40 mg twice a day. During~     weeks 2-6, the ziprasidone dose may be increased up to 80 mg twice a day.~   "
244706|NCT00350987|"~     The aim of this study is to test if procalcitonin (PCT) guided antibiotic stewardship in~     patients with lower respiratory tract infection (LRTI) will be non-inferior, with at worst a~     7.5% higher combined failure rate, as compared to standard care practice (current guidelines~     for LRTI) with reduced total antibiotic (AB) use and hospitalization rate and duration,~     respectively.~   "
244707|NCT00350974|"~     Asymmetric dimethylarginine, ADMA, in plasma, is significantly elevated in patients with~     renal disease and associated with cardiovascular morbidity and mortality. We found that whole~     blood (WB) possesses the metabolic pathways required for both the generation and elimination~     of ADMA and we have developed ex vivo methods to assess the WB accumulation of ADMA in~     humans. The over-arching hypothesis is that dysregulation of ADMA metabolic pathways leads to~     greater ADMA whole blood content and greater capacity to accumulate ADMA, which 1) is not~     reflected by plasma levels and 2) is a better predictor of cardiovascular outcome than plasma~     levels in end-stage renal disease (ESRD). The following specific aims will be pursued to~     characterize whole blood ADMA in ESRD:~        1. Compare and contrast baseline free plasma ADMA and total whole blood (free plus~          protein-incorporated) ADMA concentrations in ESRD patients, matched hypertensive~          controls and a normal population.~        2. Determine the capacity of WB to accumulate (the net balance of generation and~          elimination) ADMA in ESRD patients, matched hypertensive controls and a normal~          population.~      We will use state-of-the-art, high performance liquid chromatography techniques to measure~     ADMA levels in plasma and whole blood. Samples for ADMA measurements will be obtained from~     subjects with end-stage renal disease immediately before their dialysis treatments. Samples~     will also be obtained from volunteers without kidney disease. This group will be matched to~     the end-stage renal volunteers by age, gender and ethnicity. These volunteers will also be~     matched for the presence of hypertension and diabetes. The third group will consist of a~     normal population to measure the normal levels of ADMA and compare to the other two groups.~      There is growing evidence to support a pathological role of ADMA in humans. These experiments~     will enhance our understanding of how ADMA is processed in the human body and how it is~     associated with kidney disease. Potentially, these results will lay the groundwork for new~     insights into the link between ADMA and the high cardiovascular disease burden in patients~     with kidney disease.~   "
244708|NCT00350961|"~     In Denmark approximately 200 new cases of cholangiocarcinoma are diagnosed every year. No~     standard treatment exists for patients with advanced cholangiocarcinoma, and improved~     systemic treatments are needed.~      Duplets of gemcitabine, oxaliplatin and capecitabine have been evaluated in various cancers~     and several different regimens are well tolerated and active, especially in upper~     gastrointestinal cancers, exocrine pancreatic cancer and non-small cell lung cancer.~      The triplet combination of these agents has not been studied, but a triplet combination of~     gemcitabine, oxaliplatin and 5-FU infusion has been evaluated in a phase I study.~      Bi-weekly combination of gemcitabine and oxaliplatin has proven active and tolerable and~     warrants further study. In addition, fixed dose rate infusion of gemcitabine has shown~     interesting as the ability of mononuclear cells to accumulate gemcitabine triphosphate during~     therapy seems to be saturable.~      We propose a phase I-II study of a bi-weekly schedule of gemcitabine, oxaliplatin and~     capecitabine. This regimen could be feasible in an out-patients setting.~      The phase I part is a standard dose escalation study for patients with solid tumors. In the~     phase II part the recommended dose is studied in patients with advanced cholangiocarcinoma.~   "
244709|NCT00350948|"~     The purpose of this research study is to determine if Telcyta® given in combination with~     liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women~     who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal~     cancer that is refractory or resistant to platinum chemotherapy.~   "
244710|NCT00350935|"~     The main objective of the study is to contribute to a better understanding of the~     physiopathology of schizophrenia, by studying causal relationships between cognitive deficits~     and the neurobiological basis for these deficits. Processing visual information involves both~     automatic grouping processes and control processes. Automatic grouping processes allow the~     building of a global configuration from local contour information. It is necessary in order~     to recognize objects. Control processes allow tending to and prioritizing information parts.~     The paradigm the investigators use allows to dissociate these processes, and is used in order~     to characterize the impairments observed in patients with schizophrenia. It is adapted to~     fMRI in order to explore the neurobiological basis of the deficits. The investigators will~     examine whether functional disconnectivity between activated areas subtend the impairments~     observed in patients.~   "
244711|NCT00350922|"~     The purpose of this clinical trial was to determine the effectiveness of a supportive and~     educational self-management program for improving health-related quality of life (HRQOL),~     angina symptoms, and self-efficacy and resourcefulness to self-manage for chronic angina~     patients. 130 participants were enrolled in the trial for 3 months. The program, entitled the~     Chronic Angina Self-Management Program, (CASMP) was found effective for improving HRQOL,~     angina symptoms, and self-efficacy to manage symptoms, compared to usual care.~   "
244712|NCT00350909|"~     The purpose of this clinical trail is to evaluate the efficacy of a brief,~     cognitive-behavioral therapeutic intervention for adolescents reporting mild or moderate drug~     abuse (MMDA). This school-based initiative employs a collaborative effort between the~     University of Minnesota researchers and the St. Paul Public Schools. This intervention aims~     to reduce post-treatment drug use behaviors and enhance drug-use resistant cognitions and~     problem-solving skills.~   "
244713|NCT00350896|"~     The prevalence of digital osteoarthritis varies according to whether a radiological or~     clinical definition is adopted.~      Interventions: Thumb orthoses to be worn at night and usual care vs usual care. Outcome~     measures: Pain at 1 month assessed on visual analog scale is the main outcome measure.~     Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main~     secondary outcome measures.~   "
244714|NCT00350883|"~     This clinical trial tests the effectiveness of cognitive therapy (CT) to improve outcomes in~     outpatients diagnosed with schizophrenia or schizoaffective disorder who manifest prominent~     negative symptoms. It is hypothesized that patients receiving cognitive therapy will manifest~     lower negative symptom levels and improved engagement in constructive activity relative to~     patients who receive treatment-as-usual. Further, it is predicted that these differences~     between CT and TAU will be larger when patients are assessed 6 and 12 months after the end of~     treatment (18 and 24 months after study entry).~   "
244715|NCT00350870|"~     This is a study of four treatments for chronic cocaine use and may help study participants to~     control their drug use. All participants will receive weekly individual cognitive behavioral~     therapy (CBT).~   "
244716|NCT00350857|"~     To examine the safety and effectiveness of extended-release carbamazepine in the treatment of~     children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.~   "
244717|NCT00350844|"~     The goal of this study is to test the hypothesis that hydroxyurea is effective for the~     specific treatment of secondary pulmonary hypertension found on screening in children and~     young adults with sickle cell disease.~   "
244718|NCT00350831|"~     The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820~     when given orally daily to adults with advanced solid tumors.~   "
244821|NCT00349427|"~     This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type~     2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone~     is efficacious in terms of improving glycemic control.~   "
244720|NCT00350805|"~     Abnormalities in the ability to distinguish events in time may have a great impact on~     everyday life. The main objective of the study is to evaluate the magnitude of the temporal~     windows in schizophrenia, i.e. the time interval during which two events are perceived as~     synchronous. The investigators test the hypothesis that these temporal windows are enlarged,~     and check the relationship between this impairment and disorganization symptoms, in order to~     explore the link between this cognitive impairment and clinical symptoms. They explore also~     the neurobiological bases of the impairment by means of electroencephalogram (EEG)~     recordings. Event-related potentials (N50) will reveal whether or not the coding of the~     stimuli has the same temporal characteristics in patients and controls. The distribution and~     amplitude of oscillatory activities will be analyzed as a function of the synchronous or~     asynchronous response of the subject, thus allowing to explore the links between synchrony~     perception and neuronal synchronization phenomena.~   "
244721|NCT00350792|"~     A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed~     and Carboplatin in elderly patients with advanced non-small cell lung cancer~   "
244722|NCT00350779|"~     A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2~     Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome~     proliferator-activated receptor gamma (PPARg) agonist combination therapy.~   "
244723|NCT00350766|"~     The purpose of this study is to determine cell therapy efficacy in patients with ST elevation~     acute myocardial infarction (STEMI)~   "
244724|NCT00350753|"~     Erlotinib and bevacizumab have shown activity individually, as single drugs, or in~     combination with chemotherapy in upper gastro-intestinal cancers, including esophageal and~     gastro-esophageal adenocarcinomas, gastric cancer and pancreatic cancer. Biomarkers~     indicating an important role of EGF and VEGF have been found in these tumors, and in~     cholangiocarcinomas as well. There is promise that combined treatment with erlotinib and~     bevacizumab is active and tolerable in a broad range of upper gastro-intestinal cancers,~     justifying an experimental phase II-study of patients with these diagnoses, refractory or~     intolerant to standard systemic therapy.~   "
244725|NCT00350727|"~     This study is being conducted to characterize the safety/tolerability of pazopanib and~     lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients~     with recurrent Grade III or IV malignant gliomas.~   "
244726|NCT00350714|"~     The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a~     non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver~     fibrosis (>2 in METAVIR) in patients with chronic HCV liver disease.The test is a breath-test~     using a free-standing device (BreathID®) that measures metabolization of a 13C-labeled~     substrate (13C-methacetin) in real time.~   "
244727|NCT00350701|"~     This is to study the effect of replacing testosterone on different inflammatory cells in type~     2 diabetics with low testosterone levels.~   "
244728|NCT00350688|"~     While the gold standard of treatment in invasive bladder cancer is surgical removal of the~     bladder, it is well accepted that a reasonable alternative is an organ preserving approach.~     Bladder preservation can be achieved in patients with radiotherapy alone or together with~     concurrent chemotherapy. This clinical trial will assess the potential of intensity modulated~     radiation therapy (IMRT) delivered using helical tomotherapy to reduce radiation-induced~     gastrointestinal toxicity and increase the accuracy of bladder cancer irradiation.~   "
244729|NCT00350675|"~     In this ecological study we examine the impact of stress from repeated terrorist attacks~     during the second initifada on medical utilization by the Israeli population. We hypothesize~     that in weeks following serious terror attacks there will be an increase in prescriptions for~     psychiatric medications and an increased number of unexplained somatic complaints. We will~     also examine associations with overall medical utlization. We will consider age, gender and~     effects of geographic poximity to location of attacks.~   "
244730|NCT00350662|"~     Comparison of efficacy and toxicity of the combination treatment of deferiprone and~     desferrioxamine with the single agent treatment of either drug~   "
244731|NCT00350649|"~     Cognitive-behavioral coping skills therapy (CBT) is a widely used and recognized treatment~     that has been empirically validated for a range of substance use disorders, often with~     emergent effects and continuing improvement even after treatment ends. Treatment retention~     and compliance are associated with enhanced treatment outcomes in CBT. Contingency management~     (CM) also has very strong support and is associated with rapid, robust effects on targeted~     outcomes. Despite their many strengths, neither CBT nor CM is universally effective. It is~     now essential to seek strategies to maximize and extend the effectiveness of these two~     approaches and to better understand how these treatments exert their effects.~   "
244732|NCT00350636|"~     A new drug for overactive bladder is compared to placebo to determine if it is safe and~     effective. The study lasts approximately 12 weeks.~   "
244733|NCT00350623|"~     This study will test the safety and immunogenicity of an investigational Human~     Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the~     immune response to several different dose levels.~   "
244734|NCT00350610|"~     The computer-based training program (CBT for CBT) focuses on teaching basic coping skills,~     presenting examples of effective use of coping skills in a number of realistic situations in~     video form, and providing opportunities for patients to practice and review new skills while~     receiving substance abuse treatment.~   "
244735|NCT00350597|"~     This is a pilot study to describe the immunological responses and clinical outcome associated~     with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor~     (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high~     risk for recurrence (Stage II T4, III and IV).~   "
244751|NCT00350376|"~     The primary objective of this web-based, cross-sectional study is to assess and compare the~     ability to sleep, work or go to school, and to participate in leisure activities among~     subjects who are receiving Xolair treatment and subjects who were eligible to receive Xolair,~     but instead have been using Advair for at least 1 year.~   "
244752|NCT00350363|"~     Comparison of 1 day versus 1 hour application of topical Zymar.~   "
244753|NCT00350350|"~     The primary objective of the trial is to evaluate the efficacy, safety and clinical~     acceptability of OGT oromucosal spray in the relief of symptoms and signs of xerostomia in~     comparison with a saliva substitute (European Medical Device).~   "
244736|NCT00350584|"~     Posttraumatic Stress Disorder (PTSD) is very prevalent within the veteran population and is~     associated with decreased quality of life and an increased risk of developing other~     psychiatric and physical illnesses. The overarching objective of the proposed study is to~     evaluate the effectiveness of two telehealth treatment conditions in promoting healing within~     a population of veterans with full or partial PTSD. In particular, we are targeting newly~     returned veterans from the Iraq and Afghanistan conflicts. Specifically, we are comparing the~     relative efficacy of an alternative therapeutic approach, a Mindfulness based treatment, with~     a Psychoeducation treatment in reducing symptoms of PTSD and more generalized psychiatric~     symptoms, while increasing quality of life. Of note, both treatment conditions will consist~     of two in-person sessions and six brief weekly telephone calls. Participants will be 58~     veterans (29 per condition) recruited from the VA Boston Healthcare System. Assessment will~     occur before and after the delivery of the intervention. We hypothesize that while both~     treatments will result in improved outcomes, the Mindfulness intervention will promote more~     healing than the Psychoeducation intervention. Results from this project will help further~     our understanding of the role of mindfulness in treating PTSD, particularly in those veterans~     who are returning from deployment.~   "
244737|NCT00350571|"~     We will evaluate a series of interventions intended to help individuals who drop out of~     substance abuse treatment re-engage in order to improve treatment outcome.~   "
244738|NCT00350545|"~     The addition of rituximab to prednisone for the initial treatment of chronic GVHD will~     increase the overall response rate, enable a more rapid and effective steroid taper.~   "
244739|NCT00350532|"~     The purpose of this study is to compare the amount of acetylcholine release after a single~     injection of clonidine in normal volunteers and individuals with neuropathic pain.~   "
244740|NCT00350519|"~     The primary purpose of the study is to compare the effect of perioperative (the time period~     describing the duration of a participants surgical procedure) administration of PROCRIT to~     that of Standard of Care (SOC) on the proportion of participants receiving pRBC (packed red~     blood cells) transfusions (from the day of surgery to the day of hospital discharge) in~     participants undergoing elective major abdominal and/or pelvic surgery. Standard of Care is~     defined as the treatment of participants according to the hospital or institution's policy,~     but where participants will not receive PROCRIT (Epoetin alfa) or any other~     erythropoiesis-stimulating agents (ESAs) (agents that stimulate the production of red blood~     cells in the bone marrow).~   "
244741|NCT00350506|"~     To compare computed tomography (CT) images (pictures) of the coronary arteries using the~     General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients~     referred for an x-ray coronary angiography.~   "
244742|NCT00350493|"~     This is a three year follow up of a previous study where researchers at UNSW and UNewc asked~     smokers with serious mental health problems to participate in a 12-month study, to assess~     whether intervention could assist people experiencing mental illness reduce their tobacco~     smoking.~   "
244743|NCT00350480|"~     To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera)~     and a multidose, monophasic combination oral contraceptive in the treatment of~     hemodynamically stable women with non-gestational, acute uterine bleeding.~   "
244744|NCT00350467|"~     This is a randomized (patients are assigned different treatments based on chance),~     double-blind (neither the patient nor the physician knows whether drug or placebo is being~     taken, or at what dosage), active-controlled, flexible-dose, parallel group, multicenter~     study. The study consists of a screening phase, a double-blind treatment phase (6 weeks) and~     a safety follow-up phase (1 week).~      The patients in this study will be randomized to 1 of 2 treatment groups to receive extended~     release OROS paliperidone or Olanzapine once daily for the 6-week double-blind treatment~     phase. Randomization will occur in a ratio of 1 (extended release OROS paliperidone) to 1~     (Olanzapine). Patients must be hospitalized at least 14 days after entry. Those who receive~     extended release OROS paliperidone will start at a dosage of 6 mg taken daily, dose may be~     titrated up by 3mg/day every 7 days, or down rapidly based on the balance of efficacy~     (effectiveness of drug) and safety/tolerability assessed by the investigator. After the~     initial 7 days, dose could be flexible within 3-12mg/day. Those who receive olanzapine will~     start at a dosage of 5mg taken daily, dose may be titrated up by 5mg/day every 7 days, or~     down rapidly based on the balance of efficacy and safety/tolerability assessed by the~     investigator. After the initial 7 days, dose could be flexible within 5-15mg/day.~      Efficacy parameters include Positive and Negative Symptom Scale (PANSS) score, Clinical~     Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) score per~     assessment visit. The primary efficacy is the change in PANSS from baseline to the last~     post-randomization assessment. Safety assessments include the adverse events, changes in~     physical examination, vital signs, laboratory tests at pretreatment and posttreatment.~   "
244745|NCT00350454|"~     The purpose of this study is to evaluate the efficacy of 3 different rapamycin-eluting-stent~     platforms to reduce coronary artery reblockage after stent implantation~   "
244746|NCT00350441|"~     Does pre-operative administration of Sildenafil (Viagra, Pfizer) reduce the lung injury~     associated with cardiopulmonary bypass in children undergoing corrective surgical repair of~     congenital heart disease.~   "
244747|NCT00350428|"~     This is a randomised controlled clinical trial to compare laser peripheral iridotomy (LPI)~     and primary phacoemulsification with intra-ocular lens implantation (phaco/IOL) in the~     treatment of acute primary angle-closure glaucoma (APACG). Following successful medical~     lowering of raised intra-ocular pressure (IOP) and control of intraocular inflammation,~     patients presenting to Singapore National Eye Centre and Singapore General Hospital with~     acute primary angle-closure glaucoma who meet the eligibility are randomised to one of the~     two treatment arms: laser peripheral iridotomy and primary phacoemulsification with~     intra-ocular lens implantation. These patients will be monitored closely for 2 years~     post-operatively.~   "
244748|NCT00350415|"~     A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety~     and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg~     mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).~   "
244749|NCT00350402|"~     The purpose of this study is to examine the effectiveness of high intensity respiratory~     muscle strength training in treating blunted facial expression in people with Parkinson~     disease.~   "
244756|NCT00350298|"~     Patients with Clostridium difficile associated disease who fulfill the eligibility criteria~     will be approached to participate. All study patients must receive standard of care treatment~     for Clostridium difficile associated disease. Enrolled patients will be randomized to receive~     a single intravenous solution of a human monoclonal antibody (huMab) to C. difficile toxin A~     (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or~     0.9% sodium chloride as placebo in a 1:1 treatment allocation.Patients will be evaluated for~     safety and clinical outcomes through day 84 +/- 10 days. Occurrence of adverse events, use of~     concomitant medications, and stool output will be assessed at scheduled phone contacts and~     study visits. Some patients enrolled will have a subsequent visit on day 168 ± 14 days.~   "
244757|NCT00350285|"~     This behavioral research is an efficacy trial evaluating an intervention called The Teen~     Marijuana Check-Up with non-treatment seeking adolescent marijuana users.~   "
244758|NCT00350272|"~     Elvucitabine is a novel nucleoside analog that is being studied as a treatment for patients~     infected with HIV-1. This Phase II study will enroll 60 HIV-1 naive subjects to assess the~     efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and~     efavirenz measured by changes in the patient's HIV-RNA level and CD4 cell count. The study~     treatment will be 12 weeks of blinded study medication followed by an additional 84 weeks of~     open label treatment if the patient's response to treatment meets certain endpoints. Also~     there will be assessment of the pharmacokinetics of elvucitabine during the study.~   "
244759|NCT00350246|"~     This study will determine if there are short- and long-term postoperative differences in~     visual and corneal outcomes between different laser refractive surgical procedures.~   "
244760|NCT00350233|"~     The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the~     treatment of metastatic bone tumors.~   "
244761|NCT00350220|"~     The purpose of this study is to determine the best red blood cell(hemoglobin) level for~     infants and children following surgical repair of particular heart defects. These children~     often receive red blood cell transfusions after surgery, but what the best hemoglobin level~     is for them remains unknown.~   "
244762|NCT00350207|"~     This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy,~     placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of~     tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients~     homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor~     (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be~     randomised into the 16 week double-blind treatment period in which they receive either~     tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily~     administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily.~     After the 16 week treatment period all patients will receive salmeterol MDI twice daily for~     four weeks.~      The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume~     in the First Second (FEV1) measurements with an electronic peak flow meter throughout the~     study. Daily data on asthma control and use of rescue medication are recorded using an~     electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma~     Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure~     and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.~   "
244763|NCT00350194|"~     The purpose of this study is to determine the effects of omega-3 fatty acids in the form of~     fish oil supplementation (approximately 2 grams per day) on the carotid intima-media~     (CIMT)progression (primary objective) and 2)(Secondary objective) lipid markers such as LDL,~     apo-B, and LDL buoyancy, on inflammatory burden as measured by CRP, on oxidative stress as~     measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat~     derived hormone in subjects with metabolic syndrome.~   "
244764|NCT00350181|"~     To evaluate the incidence of grade II-IV acute GVHD with sirolimus and mycophenolate mofetil~     GVHD prophylaxis.~   "
244765|NCT00350168|"~     The purpose of this study is to evaluate the blood pressure lowering effects of a~     valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of~     stage II hypertensive patients (MSSBP ≥ 160 mmHg).~   "
244766|NCT00350155|"~     This study is designed to investigate the potential differences in GI safety and tolerability~     in the small bowel between lumiracoxib, conventional non-selective NSAID (naproxen) with a~     proton pump inhibitor (omeprazole), or placebo.~   "
244767|NCT00350142|"~     This study will assess the efficacy of treating locally advanced pancreatic cancer using~     Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine~   "
244768|NCT00350129|"~     The primary objective is to assess the effect of glucose on retinal vascular diameter in~     otherwise healthy vasospastic subjects compared to non-vasospastic controls.~      The secondary objective is to compare the effect of glucose also on choroidal blood flow in~     otherwise healthy vasospastic subjects with non-vasospastic controls.~   "
244769|NCT00350116|"~     Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of~     chronic plaque psoriasis.~      Design: Multicenter, double-blind, randomized, placebo-controlled trial.~   "
244770|NCT00350103|"~     The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in~     reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for~     lacosamide will be used to further determine the efficacy of the standard scheme and to~     evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly~     assigned to one of three treatment groups. Subjects in two of the groups will receive~     lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to~     reach this final dose. The third group of subjects will receive a placebo. Subjects will have~     a 2 in 3 (66 %) chance of getting lacosamide.~      The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration~     will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable~     dose of lacosamide or placebo.~   "
244771|NCT00350090|"~     The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin~     alfa) administered at 40,000 Units weekly in cancer patients that are not receiving~     chemotherapy or radiation therapy.~   "
244772|NCT00350077|"~     The purpose of this study is to see if intravenous Vitamin C will decrease the amount of IV~     fluids needed following burn injury in the first 48 hours.~   "
244773|NCT00350064|"~     The purpose of this study is to determine if sixteen weeks of high intensity physical~     training is more effective than sixteen weeks of low intensity physical training in reducing~     abdominal fat and lowering risk factors associated with the metabolic syndrome. Another aim~     of this study is to determine if high intensity physical training improves cognitive~     function.~   "
244774|NCT00350051|"~     The purpose of this study is to evaluate whether treatment with a new drug called~     ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate~     cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA~     (Prostate-specific antigen) levels.~   "
244775|NCT00350038|"~     The rationale of the study is to clarify whether the supplementation of irbesartan with~     ciprofibrate could increase the antihypertensive effect, could improve the endothelial~     functions, and/or could affect the atherogenic small-dense LDL-, oxydized LDL concentrations,~     onto the paraoxinase activity and on the CRP and insulin levels.~   "
244776|NCT00350025|"~     The purpose of this research study is to determine whether the investigational drug~     cetuximab, (Erbitux) alone or with paclitaxel (Taxol) can stabilize the growth of urothelial~     cancer.~   "
244777|NCT00350012|"~     The purpose of this research study is to learn how people distribute their visual attention~     when looking at objects nearby versus far away, and why vision may become distracted at near~     versus far distances.~   "
244778|NCT00349999|"~     The purpose of this study is to better understand how the body fights and protects against~     cholera. Two hundered fifty people presenting to the International Centre for Diarrhoeal~     Diseases Research, Bangladesh, admitted with acute cholera, 50 of whom (healthy, nonpregnant,~     18-45 year olds) will be enrolled in this substudy of mucosal immunity involving duodenal~     biopsy. The remainder of the study is observational, involving collection of stool, vomit,~     and blood samples only. The biopsy requires a flexible tube with a camera be inserted through~     the mouth into the stomach and intestine. During this procedure, small samples will be~     collected from the intestine. The study includes medical history, physical, blood testing,~     hospitalization and urine pregnancy testing. This study will last for 5 years and patients~     will participate for 3 years.~   "
244779|NCT00349986|"~     The rationale of the study is to determine:~        -  the first dose and the titration of basal insulin~        -  the exact daily time administration of basal insulin in poorly controlled type II~          diabetic patients.~   "
244780|NCT00349973|"~     This is a 6-week, randomized, double blind, parallel groups designed, olanzapine-controlled~     trial of oral dipyridamole in symptomatic patients with a (DSM IV) diagnosis of~     schizophrenia, schizoaffective or schizophreniform disorder. This pilot study aims to provide~     preliminary estimates of whether the effect sizes of dipyridamole on positive symptoms,~     negative symptoms, and cognitive deficits differ between schizophrenia patients treated with~     dipyridamole, and schizophrenia patients treated with olanzapine. A total of 30 subjects will~     be recruited locally.~   "
244781|NCT00349960|"~     Currently, less frequent than once weekly subcutaneous epoetin administration regimens were~     shown to be equally effective and safe as the once-weekly schedules in stable pre-dialyzed~     and peritoneal dialyzed patients Bioequivalence of once-every-two-weeks and once-weekly~     subcutaneous administration of the same total dose of epoetin beta for the maintenance phase~     of anemia treatment in stable, iron-replete, chronic hemodialyzed patients was therefore~     prospectively investigated.~      two treatment schedules will be considered equivalent if the primary efficacy parameters will~     be simultaneously similar for both groups and in the predefined range of variation.~     Confidence intervals (CIs) will be used to compare groups. Since the target Hb in dialyzed~     patients is defined as 11g/dL (110 g/L) by the European Guidelines and as >10 g/dL (100 g/L)~     by the National Guidelines, with a recommended upper limit of 13 g/dL (130 g/L), the efficacy~     range for Hb in this study was predefined as 10-12 g/dL (100-120 g/L). The two treatment~     schedules will be considered to have similar efficacy if the mean Hb in Group 2w will not~     differ by more than ±0.5 g/dL (±5 g/L) compared to Group 1w during the assessment period.~     Once similar efficacy established, drug requirements will be compared calculating the ratio~     of the mean weekly epoetin doses in Group 2w/Group 1w. A range of 0.8 to 1.25 for the ratio~     is considered sufficient to define bioequivalence. Equivalence of drug usage in the two arms~     will be accepted if the whole 95% CI for this ratio will be within the above limits.~      Lack of difference between group means does not imply similar distribution of treatment~     effects within each group. The individual hemoglobin change will be used to assess if~     response to treatment was similarly variable in the two arms. The change in Hb will be~     calculated for each patient as the difference between the mean Hb during the assessment~     period and the mean Hb during the baseline phase.~   "
244782|NCT00349947|"~     An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta,~     which is a large blood vessel in the abdomen. If an AAA ruptures, it can be life-threatening.~     Research has shown that sedentary individuals are at increased risk of developing AAAs. This~     study will evaluate the effectiveness of an exercise program at limiting the growth of small~     AAAs in older individuals.~   "
244783|NCT00349934|"~     Open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory~     setting in patients receiving as a first line chemotherapy for metastatic breast carcinoma~     the standard 6 cycles of weekly paclitaxel (80 mg/m² at D1, D8 and D15 of a 4-week cycle).~     Three IMP321 doses (0.25, 1.25 and 6.25 mg) will be tested and given at D2 and D16 of this~     4-week cycle, for 6 courses.~   "
244784|NCT00349921|"~     The purpose of this study is to determine the effects of clonidine and adenosine on nerve~     pain.~   "
244785|NCT00349908|"~     Feasibility study to assess safety of treating patients with self expanding stent in~     intracranial arteries.~   "
244786|NCT00349895|"~     This is a multi-center, prospective, non-randomized study. Approximately 90 patients from up~     to 16 centers will be entered in the study. Patients will be followed clinically for up to 5~     years post-procedure. All patients will have a repeat angiography at 6 months follow-up.~      The primary objective of this study is to evaluate the safety and effectiveness of the Genous~     Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin),~     in the treatment of elective patients with up to two de novo native coronary artery lesions.~     The Genous stent received CE mark for the intended indication in August 2005~   "
244787|NCT00349882|"~     The purpose of this study is to compare the performance of two different contact lens care~     solutions, specifically their affects on the front surface of the eye.~   "
244788|NCT00349869|"~     The purpose of this study is to evaluate the impact of yoga on inflammatory arthritis and~     knee osteoarthritis.~   "
244789|NCT00349856|"~     The purpose of the study is to evaluate the fit and performance of an investigational soft~     contact lens in comparison with a currently marketed lens. Both lenses will be worn on a~     continuous wear basis, which means the lenses will be worn while sleeping.~   "
244790|NCT00349843|"~     The primary objective of this study is to compare subjective ocular symptoms and corneal~     staining over time in a group of individuals who wear soft contact lenses on a daily wear~     basis, whilst they sequentially use two different contact lens care regimens.~   "
244791|NCT00349830|"~     The purpose of this study is to measure the levels of serum proteins and other biomarkers in~     cancer patients and in patients suspected of having cancer. We believe that some of these~     markers may be useful for confirming the diagnosis or for selecting patients for specific~     types of cancer therapies. These markers may also help to predict response to therapy,~     relapse after therapy, and survival after therapy.~   "
244792|NCT00349817|"~     This study examines the best way to teach genetics to family medicine residents. First year~     family medicine residents at the University of Toronto will be taught basic clinical genetics~     as well as a specific disease in genetics via 3 different educational methods. All~     participants will undergo an oral examination and written knowledge test 3 months after this~     education. Results between groups will be compared, and the best way to teach genetics to~     residents determined.~   "
244793|NCT00349804|"~     The purpose of this study is to test if temperature homeostasis in football players can be~     improved by circulating cool, dry air underneath shoulder pads between periods of intense~     physical activity.~   "
244794|NCT00349791|"~     This study is designed to evaluate efficacy and safety of a testosterone patch as treatment~     for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin~     therapy.~   "
244795|NCT00349778|"~     This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to~     treat multiple myeloma. The study is being performed to evaluate the efficacy and side~     effects of treatment. Specifically, the study is designed to reduce the risk of interstitial~     pneumonitis.~   "
244796|NCT00349765|"~     The purpose of this study is to determine whether snacks differing in fat amount and type~     result in changes in cardiovascular disease risk factors in men and women who have mildly~     elevated cholesterol levels. Our hypothesis is that a diet containing snacks rich in~     polyunsaturated fats lead to a more favorable cardiovascular disease risk profile than a diet~     containing snacks rich in saturated and trans fats or one containing low-fat snacks.~   "
244797|NCT00349752|"~     The current study is designed to measure the corticosteroid-sparing effect of certolizumab~     pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe~     Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at~     a dose no higher than 30 mg/day prednisone or equivalent during the week prior to~     randomization.~   "
244798|NCT00349739|"~     The purpose of this study is to evaluate whether anecortave acetate can slow or stop the~     progression of age-related macular degeneration in patients who do not qualify for other~     studies and have no other treatment options.~   "
244799|NCT00349726|"~     This pilot study was a randomized, placebo-controlled, clinical trial to measure changes in~     blood and urine levels of inositol in premature infants at high risk for retinopathy of~     prematurity (ROP) following a single intravenous dose of inositol. Based on previous studies,~     the premise is that maintaining inositol concentrations similar to those occurring naturally~     in utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants.~     The objective was to evaluate the single-dose pharmacokinetics and safety of different~     amounts of intravenous myo-inositol (provided by Ross Products Division, Abbott Laboratories)~     in very low birth weight neonates, in preparation for a future Phase III multi-center~     randomized controlled trial. This study enrolled 74 infants at high risk for retinopathy at 9~     NICHD Neonatal Research Network sites, and randomly assigned them to receive either 60mg/kg~     of 5% inositol, 120 mg/kg of 5% inositol, 60 mg/kg of 5% glucose (the placebo), or 120 mg/kg~     of 5% glucose.~   "
244800|NCT00349713|"~     Malaria is a disease that affects many people in Africa and in Mali. It is caused by germs~     that are spread by mosquito bites. This study will look at the safety, effectiveness, and~     best dose of an experimental malaria vaccine in people who are regularly exposed to malaria.~     Study participants will be 60 adults, 18-55 years old, who live in Bandiagara, Mali.~     Volunteers will get either 3 full doses of the experimental malaria vaccine, 3 half doses of~     the malaria vaccine, or a rabies vaccine that has been approved in Mali. (Rabies is an~     infection of the brain that usually causes death, and can be caught from being bitten by~     infected dogs or bats.) The 3 vaccinations will be given by injection into the upper arm 30~     days apart. Volunteers will be enrolled in the study for approximately 12 months after the~     first vaccination. Volunteers will have 14 blood samples collected during the study for~     testing to make sure that the vaccine is not harmful and to measure the effect of the~     vaccine.~   "
244801|NCT00349700|"~     The purpose of the study was to investigated if modern wound dressings adapting to wound~     exudation and the amount of bacterial colonization can heal large therapy resistant leg~     ulcers which had a pre-treatment with compresses, ointments and gauze~   "
244802|NCT00349687|"~     The proposed study will investigate the role of self-control in smoking cessation and whether~     interventions that improve self-control can help reduce the risk of lapsing among smokers who~     wish to quit. Our model predicts that the regular practice of self-control should lead to a~     building of strength and a general improvement in self-control performance. Hence, smokers~     who practice self-control prior to quitting should be more likely to succeed in their~     cessation attempt than smokers who do not practice self-control~   "
244803|NCT00349674|"~     Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients~     with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent.~     This point warrants the prescription of a maintenance treatment with a less toxic~     immunosuppressant for several months to years. The optimal drug in this indication is not~     determine. We decided therefore to compare the 2 most used drugs in this indication.~     Induction therapy consists in the combination of corticosteroids and intravenous~     cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone~     pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks,~     then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide~     is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - D1, 15 and 30), then every 3~     weeks (0.7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0.7 g/m2).~     At that time, patients are randomized for a maintenance treatment with azathioprine (2~     mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then~     progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of~     25 mg/wk) for 12 months.~   "
244822|NCT00349414|"~     The aim of this study is to compare the safety and efficacy of conventional and micropulse~     transscleral diode laser in the treatment of end-stage glaucoma.~   "
244804|NCT00349661|"~     Objectives: A prospective investigation of the effect of omeprazole, a proton pump inhibitor,~     on the anti-platelet action of clopidogrel.~      The main decision criterion will concern change in VASP protein phosphorylation under~     treatment. Phosphorylation will be measured before and after administration of omeprazole~     versus placebo in patients undergoing clopidogrel treatment.~      Type of study: Single center, double blind, randomized parallel group study versus placebo,~     comparing two treatment groups:~        -  clopidogrel + omeprazole + standard regime (beta-blockers, atorvastatin, IEC, aspirin)~        -  clopidogrel + placebo+ standard regime (beta-blockers, atorvastatin, IEC, aspirin)~      Study population: 120 patients from the Cardiology Department of Brest University hospital,~     Brest (France), receiving a standard treatment comprising a loading dose of clopidogrel~     followed by a daily dose of 75 mg associated to 75 mg aspirin, will be randomized between 20~     mg/day omeprazole and 20 mg/day placebo treatment groups. The efficacy of clopidogrel will be~     assessed by inter-group comparison on the VASP test.~      Study period: 7 days' treatment per patient. Total study period estimated at 6 months.~      Expected findings: The results should confirm the suspected negative effect of omeprazole on~     clopidogrel's impact on arterial thrombosis risk, secondarily allowing new recommendations to~     be drawn up for this association.~   "
244805|NCT00349648|"~     Study hypothesis: The impingement syndrome of the rotator cuff is a common cause of shoulder~     pain for which the most effective treatment is unknown. Steroid injections and~     anti-inflammatory analgetics are considered as effective methods. Physiotherapy and~     acromioplasty are commonly used treatments.~      Hypothesis: Arthroscopy and acromioplasty in addition to conservative treatment is equally~     effective as conservative treatment alone for shoulder impingement syndrome.~   "
244806|NCT00349635|"~     To investigate the effect on body weight of a combination fenofibrate and metformin on top of~     a moderate balanced calorie-deficit diet.~   "
244807|NCT00349622|"~     The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in~     amyotrophic lateral sclerosis (ALS).~   "
244808|NCT00349596|"~     The goal of this clinical research study is to find the safety of decitabine in patients with~     acute lymphocytic leukemia. Upon agreement of the patient, additional blood and bone marrow~     samples to be used to evaluate the effect of the treatment on leukemic cells. Also, with~     agreement of the patient, any leftover blood and bone marrow samples that are collected at~     the start of the study and during the regularly scheduled evaluations to be sent for research~     studies. The research studies will examine changes in the blood and bone marrow cells that~     might help explain the causes of leukemia.~   "
244809|NCT00349583|"~     The purpose of this study is to evaluate the efficacy on quality of vision and dry eye signs~     and symptoms in patients undergoing cataract surgery using the ReZoom® multifocal IOL.~   "
244810|NCT00349570|"~     Intra-coronary thrombosis and thromboembolism continues to be a challenge for percutaneous~     coronary and other vascular interventional techniques. The Xtract™ Aspiration Catheter is a~     single use device designed to remove fresh, soft emboli and thrombi from the arterial system~     using standard catheter techniques, compatible with 6 Fr guide catheters and 0.014~     guidewires. The purpose of this registry study is to validate the design and demonstrate the~     performance of the Xtract Aspiration Catheter as a thrombectomy catheter during percutaneous~     intervention of vessels in the arterial system. Subjects will be enrolled during percutaneous~     intervention when the Interventional Physician decides a thrombectomy catheter is needed to~     remove thrombus during the procedure.~   "
244811|NCT00349557|"~     The purpose of this study is to determine the acute and late toxicities from radiation~     therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks~     for 12 weeks), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2~     years).~   "
244812|NCT00349544|"~     The primary purpose of this study is to adapt the Neck Disability Index (NDI)and the Cervical~     Core Set 6 (CCS6) to the Spanish population. Other objectives are to determine the~     correlation between intensity of cervical pain, degree of disability, and quality of life; to~     determine the correlation between the NDI, CCS6 and the Northwick Park Neck Pain~     Questionnaire; and to determine factors that predict the chronification of disability.~   "
244813|NCT00349531|"~     The primary objective of this study is to investigate the effects on RLS symptoms and sleep~     disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks,~     compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome~   "
244814|NCT00349518|"~     The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant~     or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic~     myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The~     efficacy of the drug in this kind of patients will also further be documented.~   "
244815|NCT00349505|"~     Phase II to study results and morbidity of intra peritoneal hyper-thermic chemotherapy as~     consolidation therapy in patients with FIGO stage IIIC epithelial ovarian carcinoma treated~     by surgery and a total of 6 cycles of platinum based chemotherapy.~      A second look operation is performed after treatment; during this second look secondary~     cytoreductive surgery is accepted without bowel resection.If none or milimetric peritoneal~     disease is obseved an intraperitoneal chemotherapy is achieve~   "
244816|NCT00349492|"~     This study is a randomized, multi-center clinical trial. Patients are stratified according to~     performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2~     treatment arms.~      Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses~     repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on~     day 1. Coursed repeated every 3 weeks~      Treatment in both arms continues for 6 courses in the absence of disease progression or~     unacceptable toxicity.~      Patients are followed every 3 months for 1.5 years~   "
244817|NCT00349479|"~     The purpose of this study is to evaluate a standardized, system-based, barrier assessment and~     interactive educational intervention to increase appropriate t-PA use for stroke.~   "
244818|NCT00349466|"~     This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in~     adult males and females, aged 18 years and over, with a diagnosis of moderate-to-severe~     keratoconjunctivitis sicca (KCS). Patients will be randomized to receive either CF101 1 mg or~     matching placebo, given orally every 12 hours (q12h) for 12 weeks. A Screening Period of up~     to 4 weeks that includes a 2-week run-in period will precede a 12-week treatment period,~     followed by a 2-week follow-up period.~   "
244824|NCT00349388|"~     To determine whether once a day administration of Mesalamine is at least as safe and~     efficacious and administration of multiple doses a day in preventing clinical relapse of~     ulcerative colitis in children and adolescence.~   "
244825|NCT00349375|"~     Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both~     hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary~     mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall~     objective of the study is to evaluate the efficacy and safety of combining fenofibrate and~     simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.~   "
244826|NCT00349362|"~     The purpose of this study is to test the effect of testosterone treatment on glycaemic~     control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with~     insulin.~   "
244827|NCT00349349|"~     The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the~     treatment of patients failing both fludarabine and alemtuzumab.~   "
244828|NCT00349336|"~     This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state~     under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or~     FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm~     will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the~     FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated~     time on study treatment is 3-12 months, and the target sample size is <100 individuals.~   "
244829|NCT00349323|"~     The WHO Special Programme for Research and Training in Tropical Diseases (TDR) developed a~     Community-Directed Treatment (COMDT) approach, which has been adopted in the control of~     onchocerciasis and lymphatic filariasis. WHO has recommended the use of COMDT approach in the~     control of schistosomiasis and STH infections. The COMDT approach has been compared with the~     school based programmes in certain African countries,but not with the health-facility based~     approach.~      The project will be implemented in Mazabuka district of Zambia where COMDT approach will be~     implemented in the catchment area of Rural Health Centres (RHC) as a supplement to the~     health-facility-based approach. After each round of treatmenttreatment coverage and factors~     responsible for the treatment coverage will be measured in both areas. The health impact of~     the health facility based approach with and without the COMDT approach will be compared. The~     effect of the COMDT as a control approach of STH infections will be monitored on infections~     in the community of children aged 12 to 59 months.~   "
244830|NCT00349310|"~     To explore or establish the relationship between cognitive, mood and motor symptoms in PD to~     scores on depression rating scales in a naturalistic setting.~   "
244831|NCT00349297|"~     Acute dacryocystitis in adults can be a very painful disease and may not respond well to~     medical therapy.~      The purpose of this prospective non-randomised study is to determine the microorganisms~     causing acute dacryocystitis and the antibiotic sensitivities of these organisms.~      The study also aims to correlate the microbiological findings to the severity of clinical~     manifestations and evaluate the effectiveness of our current practice of aspiration and~     empiric systemic antibiotic therapy in treating patients with acute dacryocystitis and hence~     review whether there is a need to alter current management strategy.~   "
244832|NCT00349284|"~     Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and~     elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid~     triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in~     this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and~     ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile~     of this patient population.~   "
244833|NCT00349271|"~     The purpose of this study is to determine effect of cell therapy in patients with severe~     dilated cardiomyopathy~   "
244834|NCT00349258|"~     To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate~     between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic~     gonadotropin (hCG) to trigger final oocyte maturation.~   "
244835|NCT00349245|"~     The objective of this study is to determine the efficacy and safety of Dexmedetomidine, a~     selective alpha-2 adrenoceptor agonist, which has recently gained increased popularity for~     ICU and intraoperative sedation as a sedative during awake fiberoptic intubation, as compared~     to Remifentanil.~      The hypothesis is that Dexmedetomidine will provide at least equal if not better conditions~     (sedation and analgesia) required for awake fiberoptic intubation (Ramsay Sedation Scale 3)~     with less respiratory and cardiovascular adverse effects, as well as less recall than~     Remifentanil.~   "
244836|NCT00349232|"~     The purpose of this study is to assess the prevalence of overweight and obesity in children~     attending special primary education and to evaluate the effects of a multidisciplinary~     school-based lifestyle intervention.~   "
244837|NCT00349219|"~     The purpose of this study is to compare first-line erlotinib followed at progression by~     second-line chemotherapy vs. first-line chemotherapy followed at progression by second-line~     erlotinib in the treatment of Advanced Non Small Cell Lung Cancer (NSCLC).~   "
244838|NCT00349206|"~     This phase I trial is studying the side effects and best dose of temsirolimus when given~     together with sorafenib and to see how well they work in treating patients with metastatic,~     recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with~     temosirolimus may kill more tumor cells.~   "
244839|NCT00349193|"~     Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has~     immunomodulating properties. In a previous clinical study laquinimod showed evidence of~     biological activity by reducing the number of acute brain lesions.~      The duration of the current study is 36 weeks.~   "
244840|NCT00349180|"~     This study is performed to confirm the optimal dose for THR (total hip replacement).~   "
244841|NCT00349167|"~     RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating~     patients with advanced solid tumors.~   "
244842|NCT00349141|"~     The objective of this study is to assess the safety and immunogenicity of 4 different doses~     of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be~     enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin~     antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg~     adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects~     will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects~     will be monitored for safety and for antibody response to the vaccine. A data safety~     monitoring board will review and evaluate all the safety data obtained for a dose level~     before allowing administration of the next (higher) dose.~   "
244843|NCT00349128|"~     The primary objective was to assess the effect of 3-month treatment of low and standard doses~     of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels~     in patients with type 2 diabetes and dyslipidemia.~   "
244844|NCT00349115|"~     Multiple Myeloma is a incurable disease. Thalidomide in combination with other agents are~     currently in trials for the newly diagnosed patients, we designed treatment of TCD, followed~     by high dose chemotherapy with autologous stem cell transplantation and TD maintenance~     therapy for the patients with newly diagnosed multiple myeloma.~   "
244845|NCT00349102|"~     The purpose of this study is to evaluate the interest of breath holding for the prevention of~     radiation pneumonitis following conformal radiation therapy.~      Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath~     holding during conformal radiation.~      The primary objective of the study is to establish the efficacy of breath holding, compared~     to free breathing, in the prevention of early pulmonary toxicity following conformal~     radiation.~      Several departments of radiotherapy, many pneumology units and two basic and applied research~     laboratories take part in this multicentric study.~      The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 %~     to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per~     arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion~     period should be approximately 3 years.~   "
244846|NCT00349089|"~     The purpose of this randomized phase II trial is to determine the clinical feasibility - in~     terms of patients without dose limiting toxicities or premature treatment withdrawal or death~     - of the combination of Cisplatin and Pemetrexed and of the combination of Cisplatin and~     Vinorelbine. The combination of Cisplatin / Pemetrexed is assumed to be distinctly less toxic~     than Vinorelbine / Cisplatin.~   "
244847|NCT00349076|"~     Standard treatment for locally advanced cancer of the rectum is preoperative~     chemoradiotherapy with 5-Fluorouracil (5-FU) plus 4 cycles of postoperative chemotherapy with~     5-FU. According to our previous study (CAO/ARO/AIO-94, published in the New England Journal~     of Medicine 2004; 351:1731-40) this treatment results in only 6% of local failures, yet,~     still 36% of all patients develop distant metastasis. Therefore, our new study~     (CAO/ARO/AIO-04) incorporates new drugs, i.e. 5-FU + oxaliplatin, in an effort to improve the~     control of distant metastases. It is our hypothesis that the rate of disease free survival~     will improve by 5 to 8% after 3 years of follow-up.~   "
244848|NCT00349063|"~     The purpose of this study is to compare the wettability of contact lenses disinfected with~     three marketed contact lens care solutions.~   "
244849|NCT00349050|"~     The purpose of this study is to investigate the effects of transcranial magnetic stimulation~     on pain perception.~   "
244850|NCT00349037|"~     The purpose of this study is to evaluate how effective the vaccine is at preventing subjects~     developing flu symptoms after they are directly exposed to flu virus. The study will also~     evaluate how well the vaccine is tolerated at sites where administrations are given, any~     effects it may have on subjects' wellbeing and whether it can produce antibody responses in~     the body~   "
244851|NCT00349024|"~     RATIONALE: Polyvinylpyrrolidone-sodium hyaluronate gel may lessen the pain of oral mucositis,~     or mouth sores, in patients undergoing treatment for cancer.~      PURPOSE: This clinical trial is studying how well polyvinylpyrrolidone-sodium hyaluronate gel~     works in reducing pain from oral mucositis in young patients with cancer.~   "
244852|NCT00349011|"~     The purpose of this study is to determine the effects of a personalized menopausal therapy~     risk assessment and genetic counseling intervention on knowledge, risk perception, and~     decision-making in healthy women at increased risk for breast cancer.~   "
244853|NCT00348998|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Androgens can cause the growth of~     prostate cancer cells. Drugs, such as goserelin and bicalutamide, may stop the adrenal glands~     from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Bevacizumab may also make tumor cells more sensitive to radiation therapy. Giving bevacizumab~     together with hormone therapy and radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with hormone~     therapy and radiation therapy works in treating patients with high-risk locally advanced~     prostate cancer.~   "
244854|NCT00348985|"~     This phase I trial is studying the side effects and best dose of PXD101 and bortezomib in~     treating patients with advanced solid tumors or lymphomas. PXD101 and bortezomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. PXD101 may~     also cause cancer cells to look more like normal cells, and to grow and spread more slowly.~     Giving PXD101 together with bortezomib may kill more cancer cells.~   "
244855|NCT00348972|"~     To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes~     (IFG or IGT).~   "
244866|NCT00348829|"~     The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients~     with secondary mitral insufficiency and CHF.~        1. Identification of hemodynamic parameters as predictor for a successful mitral valve~          reconstruction in CHF patients.~        2. Collection of clinical factors for the assessment of the postoperative course after~          mitral valve reconstruction in CHF patient.~   "
244901|NCT00348374|"~     The current trial will examine the efficacy and safety of Exubera administered as a mealtime~     insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or~     = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion~     of subjects to reach target glycosylated hemoglobin (A1C) levels.~   "
244856|NCT00348959|"~     The 'Open Window' Study is a prospective longitudinal study using a 4 group randomised~     control trial design to evaluate the psychological effect of 'Open Window' on the~     consequences of long term isolation on patients undergoing stem cell transplantation~     treatment of haematological malignancies. This study uses a randomised control trial design,~     which is widely used in healthcare settings to test the effects of interventions and testing~     cause and effect relationships between variables. A mixed methods approach for data~     collection and data analysis is being used. This will facilitate measurement of patients'~     psychological response to 'Open Window' using questionnaires and exploration of subjective~     feelings in relation to personal experiences of having a stem cell transplant through semi~     structured interviews.~      Hypothesis to be tested~      'Open Window' has no effect on patients' levels of anxiety, depression, or distress when~     undergoing a stem cell transplant.~      Results:~      Of the 199 patients in the study, 96 were randomized to the intervention group and 103 to the~     control group. Participants in the intervention group had significantly reduced levels of~     anxiety on the day before transplant (P = 0.001), at day 7 (P = 0.041), and day 60 (P =~     0.035). There was a significant reduction in depression before transplant (P= 0.022).~     Participants in the intervention group reported better experiences (P < 0.005).~   "
244857|NCT00348946|"~     The purpose of this study is to evaluate the effects of low-dose androgen on the motor and~     cognitive development of boys with Klinefelter syndrome.~   "
244858|NCT00348933|"~     Angelman syndrome (AS) is a complex genetic disorder that affects the nervous system. The~     purpose of this study is to determine the effectiveness of certain dietary supplements in~     treating the symptoms of AS.~   "
244859|NCT00348920|"~     This study is looking at the effects of high spinal anesthesia (also known as total spinal~     anesthesia) combined with general anesthesia versus general anesthesia alone on the~     following:~      Stress response: Patients undergoing aortic valve replacement surgery have a large incision~     and a complex operation where they must be placed on the heart-lung machine. The body reacts~     to the heart-lung machine, increasing the stress response.~      High spinal anesthesia using local anesthetics when combined with general anesthesia has been~     shown to block some of the stress response to surgery and the response to the heart-lung~     machine. This study will examine if blood levels of stress hormones and also inflammatory~     mediators can be lowered with the use of high spinal anesthesia.~      Heart function: High spinal anesthesia in combination with general anesthesia may help the~     heart work better when there is a narrowed valve (aortic stenosis). The heart may also have~     improved ability to pump blood with this anesthetic technique.~      Lung function and post-operative pain control: After surgery, patients often have pain which~     prevents them from taking deep breaths and coughing. This can lead to pneumonia. This study~     will also examine if the post-operative pain relief provided by spinal morphine (given~     together with the spinal anesthetic) can provide any better pain control following surgery.~     By doing this, we want to see if patients can take bigger breaths after their surgery when~     spinal morphine is used, and try to prevent the complications that occur if patients are not~     able to breath deeply after surgery.~   "
244860|NCT00348907|"~     The main objective of this study is to demonstrate that hydrotherapy in a specific place can~     reduce the risk of post-thrombotic syndrome.~   "
244861|NCT00348894|"~     The purpose of this study is to assess the long-term safety and tolerability of~     [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy~   "
244862|NCT00348881|"~     This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T~     combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6,~     10, and 14 weeks of age.~   "
244863|NCT00348868|"~     A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction~     counseling with buprenorphine/naloxone to enhanced motivational drug counseling with~     buprenorphine/naloxone for the treatment for opioid addiction in an integrated and~     nonintegrated HIV care setting.~   "
244864|NCT00348855|"~     Observational studies performed in France and abroad in hypertensive patients at high~     cardiovascular risk have shown a wide gap between the therapeutic targets reached in~     ambulatory patients and those set by guidelines. In primary prevention, in hypertensive~     patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1)~     the ignorance of the validated therapeutic targets and strategies, 2) the absence of global~     cardiovascular risk management, 3) the usual ambulatory medical practice, which is not~     adapted to a global cardiovascular prevention approach.~      Objectives Principal. To demonstrate that a series of 5 specific prevention consultations~     over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to~     reach the goals set by guidelines with no deterioration of their quality of life compared~     with no particular intervention.~      Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk~     hypertensive patients will be included and followed up during two years by 268 teaching~     general practitioners from 23 regional teaching colleges. The regional teaching colleges will~     be randomised to avoid a contamination bias. The study will be coordinated by local~     coordinators at the college level.~      Intervention In the intervention group, the investigators will have training, information,~     and feed back regarding the management of high risk hypertensive patients. The training will~     concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and~     scientific data. The investigators will have an easy guide that can be used during~     consultations, and will be informed about tobacco withdrawal programs and education for~     improving diet, exercise and compliance.~      In the control group, investigators will care for their patients as usual. End points Main:~     number of patients who reach all the therapeutic targets defined by the guidelines in the~     total study population, in the sub-group of patients with hypertension, but free of type-2~     diabetes (T2D), and in the sub-group with hypertension and DT2.~      Secondary: number of targets reached by the patients, changes in level of blood pressure,~     LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total~     population and its two subgroups, estimated cardiovascular risk, quality of life.~   "
244865|NCT00348842|"~     NDV is a virus tht is harmful in chicken, but harmless in man. There are 2 major sub-strains~     of NDV, one oncolytic and one non-oncolytic. Oncolytic NDV (MTH-68H) preferentially homes and~     replicates in cancer cells and therefore, administration of NDV intravenously or~     preferentially intra-tumor, either by direct injection or by injection into an afferent~     artery results in direct lysis of tumor cells. NDV activates apoptotic mechanism in cancer~     cells and thus, results in natural cell death.~      Both oncolytic and non-oncolytic NDV were used clinically in hundreds of patients with~     different types of cancer worldwide. NDV were proved harmless in man. Clinical studies were~     done for more than a decade and the efficacy of NDV was documented on pre-clinical animals~     models as well as in man.~      For a large number of patients with metastatic cancer and chemotherapy resistant~     hematological malignances, no cure can be provided by conventional anti-cancer modalities,~     new treatment options are urgently indicated. The goal of the study is to use NDV, in order~     to provide such treatment for patients in need.~   "
244902|NCT00348361|"~     This study is aimed at validating key therapeutic targets and biomarkers associated with~     allergic rhinitis. The therapeutic target expression will be investigated after a 7 day~     course of corticosteroid treatment followed by allergen challenge.~   "
244867|NCT00348816|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make~     tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation~     therapy and prednisone after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation~     therapy and prednisone works in treating patients who have undergone surgery for prostate~     cancer.~   "
244868|NCT00348803|"~     As a pulmonary hypertension center, we have created a database that prospectively tracks~     patients with different forms of secondary pulmonary hypertension. Records include genetic~     analysis, and clinical and hemodynamic profiles.~   "
244869|NCT00348790|"~     RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor~     and by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with~     recurrent or progressive meningioma.~   "
244870|NCT00348777|"~     The main objective of this study is to evaluate the therapeutic effect of a thermal treatment~     on gonarthrosis, with an increase of the number of patients presenting a clinically~     significant improvement.~   "
244871|NCT00348764|"~     To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol~     400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study~     of 3% versus 1% Lauromacrogol 400 foam.~   "
244872|NCT00348751|"~     Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem~     to change behaviour more than requiring users to actively initiate the system. However,~     randomized trials comparing these methods in a clinical setting are lacking. In this study we~     compare the effect of Alerting physicians with a CDSS or actively requiring initiation of~     CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the~     Dutch college of General Practitioners.~   "
244873|NCT00348738|"~     The purpose of this study is to determine whether an increase of blood haemoglobin levels~     through the substitution of erythropoietin during radiotherapy treatment of cervix cancer~     patients results in improvement for disease specific survival, tumor response and local~     control.~   "
244874|NCT00348725|"~     The primary objective was to assess the acceptability of a 4-week treatment of 4 new~     fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and~     dyslipidemia.~   "
244875|NCT00348712|"~     This trial is conducted in Europe.~      The aim of this research study is to compare the efficacy of adding inhaled preprandial~     insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type~     2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin~     antibodies and side effects).~   "
244876|NCT00348699|"~     This phase I trial studies the side effects and best dose of AFP464 in treating patients with~     metastatic or refractory solid tumors that cannot be removed by surgery. Drugs used in~     chemotherapy, such as AFP464, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~   "
244877|NCT00348686|"~     The purpose of this study is to investigate effect of candesartan based therapy on percent~     change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left~     ventricular hypertrophy.~   "
244878|NCT00348673|"~     A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load~     response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the~     dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability~     of UK-453,061 in asymptomatic HIV infected subjects.~   "
244879|NCT00348660|"~     The first part of this study will investigate the incidence of Hepatitis C in pregnant women~     attending an inner city health clinic in downtown Toronto. All women attending the clinic who~     give their consent to participate will be screened by a standardized questionnaire as well as~     by a blood test. Blood testing will tell us how many of these women have Hepatitis C. We will~     then be able to compare the specificities and sensitivities of targeted screening (risk~     behaviour questionnaires) versus universal screening (blood tests).~      In the second part of the study we will follow the pregnancies of those women who were~     identified as Hepatitis C positive on the screening test. Follow- up will include liver~     enzymes and viral load quantifications (amounts) in the first, second and third trimesters as~     well as during delivery and six weeks post-partum. We will also document pregnancy outcomes~     with regard to type of delivery and complications. Pregnancy outcomes will be compared to an~     age and race matched group of women who do not have Hepatitis C.~      Study Hypothesis:~      We expect a higher incidence of Hepatitis C in this inner city population compared to the~     general Canadian pregnant population (0.9%). We predict an HCV seroprevalence (rate) ranging~     between 2-6% in this population and we also predict that targeted screening by standardized~     questionnaire will fail to identify half of the Hepatitis C positive cases.~      By following this group of Hepatitis C positive women through pregnancy, we expect to lend~     further support to previous data showing significant decrease and/or normalization of serum~     transaminases as well as significant increase in HCV viral load by third trimester. We also~     expect to see no significant differences in pregnancy outcomes or obstetrical complications~     between HCV positive women and the HCV negative women.~   "
244880|NCT00348647|"~     Overuse injuries are a major concern for physical active individuals. Study hypothesis is~     that an exercise programme based on known intrinsic risk factors can prevent overuse injuries~     in soldiers undergoing basic military training.~   "
244881|NCT00348634|"~     This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients~     over 65 years with chronic constipation.~   "
244882|NCT00348621|"~     The purpose of this clinical trial is to determine if interventions within the nursing home~     to restore vision, or cope with visual loss, in residents with visual impairment result in~     improvement or less decline in mobility scores, and socialization scores, compared to~     residents with visual impairment in nursing homes with no such intervention. The~     investigators hypothesized that nursing home residents with visual loss who receive cataract~     surgery, or refractive correction, or low vision aids would have have better socialization~     scores and mobility scores at 6 months and 12 months compared to nursing home residents with~     visual impairment who are advised to seek services, but have no specific program.~   "
244883|NCT00348608|"~     CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses~     x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins~     throughout the body VISIPAQUE™ will be given through a vein in the arm before having the CTA~     scan of the heart arteries. The pictures it produces of the heart and its blood vessels will~     be reviewed and compared to those obtained during the catheter-based coronary angiography to~     see if the CTA shows the same blockages.~   "
244884|NCT00348595|"~     The primary objectives of the study are:~        -  To evaluate feasibility, safety and tolerance of 6 months administration of Revlimid at~          5mg/day and 25mg/day, given orally in subjects with prostate cancer with evidence of~          biochemical relapse (M0) following local treatment (i.e., surgery or radiation).~        -  To assess the rate of PSA (prostatic specific antigen) progression at 6 months after~          treatment with 5mg/day and 25mg/day of Revlimid (CC-5013) in patients with evidence of~          biochemical relapse after local therapy.~      The secondary objectives of the study are:~        -  To provide preliminary assessments on the effects of Revlimid (CC-5013) at 5mg/day and~          25mg/day on various PSA constructs in the subject population (i.e., PSADT [Prostatic~          Specific Antigen Doubling Time] and PSA slope) by comparing pre and post treatment~          patterns in each arm.~        -  To evaluate preliminary pharmacodynamic correlations between serum revlimid~          concentrations and toxicity, PSA constructs and other evidence of disease progression.~   "
244885|NCT00348582|"~     The purpose of this study is to compare the clinical outcomes, safety and efficacy in~     patients randomized to receive either ketorolac or nepafanac following cataract surgery.~   "
244886|NCT00348569|"~     To compare computed tomography (CT) images (pictures) of the coronary arteries using the~     General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients with~     typical or atypical chest pain suspected of coronary artery disease (CAD).~   "
244887|NCT00348556|"~     The objective of this study is to determine the safety and effectiveness of intrarenal~     administration of brain natriuretic peptide (BNP) in improving renal function as measured by~     glomerular filtration rate (GFR) and sodium excretion in patients hospitalized with acute~     congestive heart failure (CHF) and deterioration of kidney function (cardiorenal syndrome).~   "
244888|NCT00348543|"~     To study the effect of mild laser treatment on the incidence of exudative complications in~     soft drusen maculopathy. We hypothesise that mild laser treatment causing a proliferation of~     the retinal pigment epithelium and enhancing the capacity of clearing drusen material from~     Bruch's membrane.~   "
244889|NCT00348530|"~     Accumulated clinical and experimental data suggest that dysfunctional coronary~     microcirculation plays a pivotal role in the progression of heart failure despite an optimal~     therapy used. Therefore, we hypothesize that improvement in microvascular function by calcium~     antagonist, verapamil may result in additional clinical benefit. Thus, the aim of this study~     is to compare the effect of treatment with verapamil or carvedilol on long-term outcomes in~     stable, chronic heart failure secondary to non-ischemic cardiomyopathy.~   "
244890|NCT00348517|"~     The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783~     when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of~     dry eye patients.~   "
244891|NCT00348504|"~     The primary objective of the study is to compare the efficacy of levosimendan and dobutamine~     on all-cause mortality in the 180 days following randomization.~   "
244892|NCT00348491|"~     This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to~     severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.~   "
244893|NCT00348478|"~     There are no specific trials addressing the benefit of water provision and health education~     on prevalence of trachoma and infection with ocular Chlamydia trachomatis over time, despite~     considerable effort to provide water resources in trachoma endemic areas. Such information is~     sorely needed, to advance the Global Alliance agenda for the Elimination of Blinding~     Trachoma. This community-based clinical trial will randomize ten communities in Maradi Niger,~     half to receive delivery of water and health education services, and half for delivery of~     services at a later date. We hypothesize that the intervention communities will have lower~     rates of trachoma and C. trachomatis one and two years after delivery of services compared to~     communities without such services. This trial will provide, for the first time, solid~     evidence of the effect of such services on trachoma, as well as the added benefit following~     antibiotic provision by the Ministry of Health on sustaining reductions in trachoma and~     infection.~   "
244894|NCT00348465|"~     The size of the prostate changes due to insertion of the radioactive seeds. We will measure~     the prostate size, before and after the procedure.~   "
244895|NCT00348452|"~     The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER~     100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe~     pain due to OA. For the purposes of this study, celecoxib will serve as a positive control to~     validate the sensitivity of the model. The study hypothesis is that tramadol HCl ER is safe~     and effective in the treatment of moderate to severe pain due to OA.~   "
244896|NCT00348439|"~     Plasmin is expected to create a posterior vitreous detachment. The pharmacological creation~     of a posterior vitreous detachment may be beneficial in a variety of conditions.~   "
244897|NCT00348426|"~     A second botulism outbreak in Northern Thailand was reported in 2006. 192 people were exposed~     to raw meat and the gut of deer, 83 suffered from diarrhea. Of these 5 developed respiratory~     failure, 1 impending respiratory failure.~      We analysed the clinical findings and electrophysiologic findings in this second episode of~     large botulism outbreak in northern Thailand.~   "
244898|NCT00348413|"~     This project will compare the efficacy and safety of 2 methods of disease modification in the~     treatment of active moderate and severe thyroid orbitopathy. A prospective, randomized,~     double-blind, parallel, controlled multidisciplinary clinical trial involving Singapore~     National Eye Centre, National University Hospital, Changi General Hospital, Tan Tock Seng~     Hospital and University of British Columbia Orbital Services, Singapore Eye Research~     Institute, Singapore General Hospital Endocrinology and Radiology Departments and Tan Tock~     Seng Hospital Rheumatology Department is planned. The SingHealth-SGH High Field MR Research~     Laboratory will be involved in the MR imaging of the trial patients.~      Patients who satisfy the inclusion and exclusion criteria will be asked to participate in~     this trial. After informed consent (Appendix B) is obtained, each patient will be randomized~     into one of two treatment arms: 1) Intravenous high-dose pulsed methylprednisolone (1 gram~     infusion over 1 hour per day with a total of 3 doses over 3 days; 4 cycles at 6 weekly~     intervals) and oral placebo and 2) Intravenous high-dose pulsed methylprednisolone (same~     dose) plus oral methotrexate 7.5 mg per week for 2 weeks, increased to 10 mg per week for~     another 2 weeks then 12.5 mg per week for 5 months (total 6 months of methotrexate~     treatment). Depending on patient response, the dose can be further increased by 2.5mg per~     week every 4 weeks to a maximum of 20 mg per week. A strict management protocol will be~     observed for each recruited patient. Patients who develop adverse side effects or need for~     surgical intervention will receive appropriate treatment (i.e. treatment will deviate from~     the protocol but will continue to be monitored). Patients who refuse treatment will be~     observed clinically and with imaging as a natural control group until such time as~     intervention is accepted.~      The patients will have a baseline assessment followed by regular visits to assess treatment~     response and adverse effects. Observations will include the use of an inflammatory index,~     motility measurements including quantitative ductions, exophthalmometry readings, palpebral~     aperture readings and indices of optic nerve function. With regards to the imaging, the~     patients will be assessed with an initial quantitative CT scan and 3-Tesla MRI scan prior to~     treatment. After treatment is started, patients will also undergo repeat MRI scan at 24 weeks~     and 72 weeks to assess quantitative changes with treatment using the Muscle Diameter Index~     (MDI) and Pixel Value Ratio (PVR) for the inferior rectus, superior rectus, the medial~     rectus, lateral rectus and orbital fat (Appendix E). Serum and urine will be obtained at the~     same time intervals as the MRI scan to assess levels of thyroid hormones, thyroid antibodies~     and urinary glycosaminoglycans (GAGs). Free T4, free T3 and TSH will be recorded to monitor~     control of hyperthyroidism. Thyroid antibodies measured will include thyroid stimulating~     immunoglobulin (TSI), thyrotropin-binding inhibition antibody (TB II), thyroid peroxidase~     antibodies and thyroglobulin antibody. Other tests including the full blood count, urea and~     electrolytes will be run prior to each dose of steroid treatment and during follow-up to~     monitor for adverse effects.~      The results of the assessments will be analyzed for significant differences in treatment~     response between the 2 groups. The indices of interest will include the percentage of~     patients in each group who demonstrate a decrease in the inflammatory index of at least 2~     points and the time taken for 50% of patients to show such a decrease. Other parameters that~     reflect the visual function and motility will be compared at different points in time after~     starting treatment to observe response and sustainability of response. From the serial MRI~     scans, quantitative analysis of orbital tissues will be done to identify changes with~     treatment. Antibody and GAG levels will be analyzed to detect any change with treatment. The~     types and frequency of adverse side effects in the 2 groups will also be assessed.~      80 normal subjects will be recruited for MRI scan of the orbits and brain to obtain normative~     values for the MDI and PVR for the Asian population (Appendix E). This will include 20~     subjects from each of 4 decades (21-30 years, 31-40 years, 41-50 years, 51-60 years).~      The normative data will also be used to create a virtual orbital atlas. This aspect of the~     study will be performed in collaboration with the Labs for Information Technology (A-Star).~   "
244899|NCT00348400|"~     Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as~     adjunctive therapy~   "
244900|NCT00348387|"~     This study is intended to support the registration of IMOVAX Polio in China.~      The primary objective of this Pase III trial is to compare IMOVAX Polio to the current~     Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The~     objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection~     rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV~     dose.~   "
244903|NCT00348348|"~     This is a study to investigate a novel drug candidate for the treatment of bacterial~     conjunctivitis.~   "
244906|NCT00348309|"~     Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a~     treatment for type II diabetes mellitus, a disease that occurs when the body is unable to~     effectively use glucose. RSG XR, the investigational drug used in this study, is an~     extended-release form of RSG.~      This study tests whether RSG XR safely provides clinical benefit to people with mild to~     moderate Alzheimer's disease (AD) when combined with the currently approved AD medication,~     Aricept (donepezil). RSG XR is a new approach to AD therapy and this study tests a new way to~     treat AD by testing whether one's genetic makeup affects their response to the study drug.~     Clinical data suggesting that RSG may benefit AD patients was first seen in a small study~     performed at the University of Washington and then from a larger GSK study conducted in~     Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months~     scored significantly better on 3 tests of memory and thought than those who did not receive~     RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a~     specific genetic pattern. They did not have the gene that caused them to produce the protein~     apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one~     from each parent, or they may have only one APOE e4 gene meaning that they inherited either~     the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents.~     Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability~     while those with two copies of the APOE e4 gene, continued to worsen during the 6-month~     treatment. The current study will more directly test the effectiveness or RSG XR on people~     who either have or lack the APOE e4 gene.~   "
244907|NCT00348296|"~     This randomized, double-blind, placebo-controlled multi-center study will carry out to assess~     the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in~     modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to~     assess the safety of GB-0998.~   "
244908|NCT00348283|"~     The goal of this study was to test whether adalimumab can induce mucosal healing in subjects~     with moderate to severe ileocolonic Crohn's Disease.~   "
244909|NCT00348270|"~     This study is a comparison of the quality of vision provided by AMO Tecnis Z9000 three-piece~     silicone posterior chamber intraocular lens and Alcon Laboratories MA60 three-piece acrylic~     posterior chamber intraocular lens.~   "
244910|NCT00348257|"~     Removal of unwanted hair is one of the most commonly sought cosmetic solutions. Traditional~     methods, such as shaving, depilatories, tweezing and waxing result in only temporary hair~     removal, and thus require extensive maintenance. Long term hair removal via electrolysis is~     generally unsatisfactory due to its time consuming, painful nature and the associated risk of~     scarring or pigmentary changes. Moreover, the efficacy of electrolysis is user dependent and~     is estimated to be reduction of only 15-50% of the unwanted hair3.~      The more modern approach to long term hair removal involves laser and Intense Pulsed Light~     (IPL) treatment modalities. These technologies are based on the scientific principle of~     selective photothermolysis. During the treatment, the light energy is absorbed by the hair’s~     pigment (melanin) and transmitted through the hair shaft to the follicle. Conversion of this~     energy into heat causes a rise in the hair temperature, leading to destruction of the~     follicle and disruption of the hair growth mechanism, while leaving the skin undamaged.~      Both laser and light devices have been proven successful in inducing permanent hair removal,~     as well as delayed hair growth, while causing minimal discomfort and complications. The light~     devices are based on the IPL technology, which differs from laser light in various physical~     aspects. The main difference is that while lasers emit light at a distinct wavelength, IPL~     delivers a wide range of wavelengths (400 1400 nm), thus allowing greater flexibility in~     aspects of body area, hair color and skin type LEORTEC LTD. has developed an innovative~     device that integrates the two treatment modalities: Laser and Intense Pulse Light (IPL) and~     in addition MLS - Multi Light Source- a combination of the two modalities. The purpose of~     this study is to evaluate the safety and efficacy of using Leortec 300 device for hair~     removal treatment.~   "
244911|NCT00348244|"~     Evaluate if the incidence of sub clinical CME can be significantly reduced by use of~     peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal~     cataract patients.~   "
244912|NCT00348231|"~     The purpose of this study is to compare whether there is the difference in the effect of~     insulin therapy by the number of times of insulin injection.~   "
244913|NCT00348218|"~     This is a pilot study to assess the effectiveness of Neurovision treatment in the improvement~     of vision in children being under-corrected and to assess the effectiveness of Neurovision~     treatment in slowing down myopia progression in children.~   "
244914|NCT00348205|"~     A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery~     treatments for hyperopia and astigmatism.~   "
244915|NCT00348192|"~     The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it~     has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment~     which is thought to increase the levels of certain chemicals in the brain that are often~     decreased in patients with Alzheimer's Disease.~   "
244916|NCT00348179|"~     The objectives of this investigator initiated study are to:~        1. Determine if and when vascular abnormalities occur during early adolescence~        2. Determine if poor diabetic control is related to vascular abnormalities.~      The development of vascular plaques and vascular contractility will be assessed through the~     use of the SyphmgnoCor equipment.~   "
244917|NCT00348166|"~     The purpose of this study is to find out if undercorrection of myopia slow down the~     progression of myopia in kindergarten children.~   "
244918|NCT00348153|"~     TNF alpha Inhibitors have been very effective in treating rheumatologic diseases as well as~     uveitis. Adalimumab is the first member of a new class of TNF antibody compounds developed to~     contain exclusively human sequences. We want to test the efficacy and safety of the TNF alpha~     Inhibitor Adalimumab in patients with active uveitis despite standard immunosuppressive~     therapy.~   "
244934|NCT00347945|"~     The Convergence Insufficiency Treatment Trial (CITT) is a multi-center, placebo-controlled,~     single-masked, clinical trial designed to compare the benefits of two commonly used treatment~     approaches for patients with convergence insufficiency (CI)~   "
244935|NCT00347932|"~     Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the~     treatment of bacterial conjunctivitis.~   "
244936|NCT00347919|"~     This study is being conducted to compare the efficacy and safety of pazopanib in combination~     with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic~     breast cancer whose tumors overexpress the ErbB2 protein.~   "
244937|NCT00347906|"~     The purpose of this study is to compare the effect of PDT and TTT for the treatment of~     subfoveal occult CNV in age-related macular degeneration.~   "
244919|NCT00348140|"~     Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a~     treatment for type II diabetes mellitus, a disease that occurs when the body is unable to~     effectively use glucose. RSG XR, the investigational drug used in this study, is an~     extended-release form of RSG.~      This study tests whether RSG XR safely provides clinical benefit to people with mild to~     moderate Alzheimer's disease (AD) when combined with one of the currently approved AD~     medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this~     study tests a new way to treat AD by testing whether one's genetic makeup affects the~     response to the study drug. Clinical data suggesting that RSG may benefit AD patients was~     first seen in a small study performed at the University of Washington and then from a larger~     GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG~     once daily for 6 months scored significantly better on 3 tests of memory and thought than~     those who did not receive RSG. In the GSK study, those that appeared to benefit most from~     treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused~     them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene~     may have two copies, one from each parent, or they may have only one APOE e4 gene meaning~     that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4,~     from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same~     level of thinking ability while those with two copies of the APOE e4 gene, continued to~     worsen during the 6-month treatment. The current study will more directly test the~     effectiveness or RSG XR on people who either have or lack the APOE e4 gene.~   "
244920|NCT00348127|"~     To assess how well and safe is Neurovision technology in improving the vision of people with~     low myopia in Singapore~   "
244921|NCT00348114|"~     To evaluate the effectiveness of autologous (tissue from fellow eye) transplantation of~     cultivated limbal epithelium on amniotic membrane to treat severe surface irregularity and~     scarring of the corneal surface.~   "
244922|NCT00348101|"~     Previous clinical investigations have demonstrated the utility of β-adrenergic blockade in~     reducing perioperative ischaemic events, ultimately translating into a decrease in cardiac~     morbidity and mortality. However, β-blocker therapy remains underutilized in clinical~     practice because of concerns of potential adverse effects such as a reduced inotropic state,~     which might result in acute congestive heart failure or hypotension. Therefore, additional~     treatment with a positive inotropic agent might be needed. Phosphodiesterase inhibitors~     (PDEIs) offer a favourable pharmacological profile in this setting and stimulate cardiac~     function in the absence of the β-adrenergic receptor.~      We hypothesize that the combination of PDEI and β-blocker therapy would decrease~     perioperative plasma concentrations of brain natriuretic peptide (BNP) in patients requiring~     major vascular surgery. BNP is chosen as our primary outcome variable because of its~     importance as a sensitive correlate of myocardial dysfunction and its prognostic value for~     predicting the risk of cardiac death across the entire spectrum of acute coronary syndromes.~   "
244923|NCT00348088|"~     The purpose of this study is to measure the level of a specific protein, CXCL1, in the blood~     of patients with untreated, metastatic (Stage IV) melanoma. These levels will be compared to~     blood levels in normal controls. If the levels are elevated in metastatic melanoma, further~     studies to determine if this correlates with presence and extent of disease will be pursued.~   "
244924|NCT00348075|"~     To evaluate the efficacy of NeuroVision NVC vision correction technology to improve the~     vision of subjects with Low and Moderate Myopia in Asian eyes in Singapore~   "
244925|NCT00348062|"~     Evaluate the incidence of hyperemia in patients using bimatoprost and to determine if simple~     interventions reduce its incidence and to assess the value of detailed instruction in~     increasing patient compliance and willingness to continue bimatoprost therapy, despite the~     occurrence of hyperemia.~   "
244926|NCT00348049|"~     Laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) are currently the~     2 main refractive surgeries to correct myopia which are being performed worldwide, with more~     patients preferring LASIK to PRK because of better comfort and faster rehabilitation.~     However, in post-LASIK patients, there is a low risk of flap dislodgement. This risk~     increases with certain occupations which have a higher risk of trauma. Hence, there may be a~     role for PRK for people which such occupations, e.g. soldiers, parachutists, sportsman.~      There are several non-randomised studies which show that PRK is as efficacious, predictable~     and safe as LASIK for low to moderate myopes. But there have been only a few randomized~     controlled studies to compare the efficacy and safety of the 2 treatment modalities and all~     studies comparing LASIK and PRK suffer from a high dropout rate during the follow-up period.~     We compared the efficacy, predictability, stability and safety of LASIK versus PRK over a one~     year duration with almost 100% attendance during all follow-up visits.~   "
244927|NCT00348036|"~     This study will assess the acceptability and effectiveness of a six-session, modular,~     repeating group for low-income women who have symptoms of depression and/or post-traumatic~     stress disorder following interpersonal trauma exposure.~   "
244928|NCT00348023|"~     Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03%~     monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of~     glaucoma or ocular hypertension.~   "
244929|NCT00348010|"~     The purpose of this study is to compare the analgesic effectiveness and safety of tramadol~     HCl ER to placebo in patients with moderate to severe pain due to osteoarthritis (OA). The~     study hypothesis is that tramadol HCl ER is effective and safe in the treatment of OA.~   "
244930|NCT00347997|"~     A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery~     treatments for myopia and astigmatism.~   "
244931|NCT00347984|"~     The objective of this study was to evaluate the effect of Systane® compared to marketed~     artificial tears on the frequency of drop use.~   "
244932|NCT00347971|"~     The purpose of the study is to evaluate whether recombinant IL-21 used in combination with~     rituximab is safe for patients with non-Hodgkin's lymphoma (NHL).~   "
244933|NCT00347958|"~     Objectives:~      To provide safety data on revaccination with ADACEL® vaccine.~      To describe the immune response to tetanus, diphtheria, and pertussis antigens following~     revaccination with ADACEL® vaccine 4-5 years after first vaccination.~   "
244981|NCT00347321|"~     This is a phase III clinical trial comparing early tracheostomy (day 4) versus prolonged~     endotracheal intubation in ICU patients needing prolonged ventilatory support after~     cardiovascular surgery.~   "
244938|NCT00347893|"~     Selective laser trabeculoplasty (SLT) is a new method to reduce intraocular pressure in eyes~     with open angle glaucoma or ocular hypertension. SLT may also be effective for cases with~     previously failed ALT procedures. We will study the efficacy and safety of the SLT procedure.~   "
244939|NCT00347880|"~     The purpose of this study is to collect information about what happens to certain chemicals~     produced in the body called hormones during respiratory infections such as bronchiolitis.~     Bronchiolitis is an infection of small airways in the lungs caused by a virus. This~     infection, which causes swelling and injury in the lungs, is commonly seen in infants and~     children less than 2 years of age.~   "
244940|NCT00347867|"~     It has been suggested that Viagra (or other drugs that inhibit PDE-5, the enzyme that~     normally inhibits blood vessels’ ability to expand) may have beneficial effects in~     hypertensive pregnancy and, possibly, preeclampsia.The benefits of Viagra were observed~     without any reduction in maternal blood pressure, thereby dissociating hypertension per se~     from the loss of NO (nitrous oxide) signaling in the uterine circulation.Following~     publications, suggesting that sildenafil citrate used as a therapeutic agent may improve~     myometrial perfusion in IUGR gestations by promoting myometrial small artery vasodilatation,~     decreasing peripheral resistance and increasing flow within the uteroplacental bed, we intend~     to administer this medication to parturients where intauterine growth restriction and~     pregnancy associated hypertension have been diagnosed in an attempt to induce vasodilatation~     and improved uteroplacental perfusion resulting in improved fetal growth.~   "
244941|NCT00347854|"~     The objective of this study is to evaluate the safety and efficacy of exaggerated use of~     Lubricant Eye Drops in a population of normal subjects by measuring corneal epithelial~     permeability to fluorescein.~   "
244942|NCT00347841|"~     To evaluate the IOP-lowering efficacy of bimatoprost 0.03% in patients found to be~     low-responders to latanoprost therapy.~   "
244943|NCT00347828|"~     The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface~     bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.~   "
244944|NCT00347815|"~     The purpose of this study is to determine the amount of buprenorphine and its metabolites in~     blood and urine after administration of 0.6 mg buprenorphine in healthy volunteers.~     Furthermore the purpose is to correlate the amount of buprenorphine in the blood with the~     effect on the ability to concentrate and coordinate.~   "
244945|NCT00347802|"~     To compare the diurnal curves in patients using bimatoprost 0.03% versus travoprost 0.004%~     for the treatment of glaucoma or ocular hypertension.~   "
244946|NCT00347789|"~     Transconjunctival mitomycin-C in needle bleb revision may be an effective procedure to treat~     cases with a previously failed trabeculectomy. We will investigate approximately 100~     consecutive cases with follow up of up to 9 years. We anticipate that this procedure is an~     effective, safe, and appropriate option for successful glaucoma treatment.~   "
244947|NCT00347776|"~     Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of~     blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar~     and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and~     abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a~     multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis.~     Despite this encouraging news, under the best of circumstances the recurrence rate of~     trichiasis following surgery is disappointingly high. The objective of our project is to~     conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment,~     comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in~     Ethiopia with the goal of determining the impact of treatment on rates of trichiasis~     recurrence at one and two years.~   "
244948|NCT00347763|"~     The purpose of this community-based randomized trial was to determine, in trachoma~     hyper-endemic communities of Tanzania, the added value of intensive spraying to control flies~     on the fly population and on trachoma and ocular chlamydia infection at 6 months and one year~     after mass antibiotic treatment.~   "
244949|NCT00347750|"~     The objective of this proposal is based on the assumption that the HIV infected Ethiopian~     population responded in a different way in comparison to the Caucasian subjects to Lopinavir~     therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum~     concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is~     to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The~     results will allow to establish a better personalised medicine for HIV infected individuals.~   "
244950|NCT00347737|"~     The purpose of this study is to determine what effect teriparatide will have on vascular~     (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).~   "
244951|NCT00347724|"~     The purpose of this study is to compare the analgesic efficacy of oral, once-daily tramadol~     ER 300 mg and 200 mg to placebo in patients with moderate to severe chronic low back pain~     requiring daily analgesic treatment. The study hypothesis is that tramadol ER is effective in~     the treatment of moderate to severe chronic low back pain.~   "
244952|NCT00347711|"~     To evaluate the effects of Intravitreal Bevacizumab in macular edema in retinal vascular~     occlusion.~   "
244953|NCT00347698|"~     The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal~     bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the~     treatment of patients with untreated symmetric proliferative diabetic retinopathy.~   "
244954|NCT00347685|"~     The purpose of this study is to assess the safety of tramadol HCl ER following long-term~     treatment. The study hypothesis is that long-term treatment with tramadol HCl ER is safe and~     effective for the treatment of chronic, non-malignant pain.~   "
244955|NCT00347672|"~     Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and~     other parts of the world. The need for a vaccine to prevent the spread of AI among livestock~     and to humans is sorely needed. The purpose of this study is to test the safety of and immune~     response to a new AI vaccine in healthy adults.~   "
244956|NCT00347659|"~     The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction~     System (BLVR) for patients with advanced emphysema.~   "
244957|NCT00347646|"~     Plasmin is expected to create a posterior vitreous detachment (PVD) when injected directly~     into the eye. The pharmacological creation of a PVD may be beneficial in helping to treat a~     variety of conditions.~   "
244958|NCT00347620|"~     The primary purpose of this study is to evaluate whether interventions to improve vision in~     nursing home residents have an impact on residents' health-related quality of life. The~     interventions being evaluated are correction of refractive error (near-sightedness,~     far-sightedness, presbyopia) and cataract surgery.~   "
244959|NCT00347607|"~     After single, yearly, mass treatment of communities with azithromycin for active trachoma,~     what is the added effectiveness for reduction of trachoma and ocular C. trachomatis infection~     at one, two, and three years, relative to the added costs, of community-based surveillance~     and treatment of cases of severe trachoma (TI) semi-annually or every 4 months?~   "
244960|NCT00347594|"~     The purpose of this study is to measure the aberrations, corneal surface topography and~     pachymetry of normal human eyes with the NGDI.~   "
244961|NCT00347581|"~     This study is designed to compare the use of special prism glasses to placebo treatment for~     children with symptomatic convergence insufficiency.~   "
244962|NCT00347568|"~     The purpose of this study is to develop a web-based decision aid to help women at high risk~     for breast cancer make informed breast cancer prevention choices. These choices include~     chemoprevention, surgery, genetic counseling, or regular screening in accordance with~     recommended guidelines.~   "
244963|NCT00347555|"~     Malaria is an illness caused by a parasite (an animal or plant that lives in or on a host)~     that enters the human body through the bite of an infected mosquito. The purpose of this~     study is to find out about the safety of an experimental malaria vaccine and whether the~     vaccine causes humans to produce antibodies (proteins made by the body's immune system to~     help control or prevent infection). Four strengths of the vaccine will be tested. The lowest~     strength of the vaccine will be tested before the next higher strength is tested. Each dosage~     (shot) of vaccine will be given to 18 people in 4 dosage groups on Day 0, at 1 month and at 6~     months. Two people in each dosage group will receive injections of a placebo (contains no~     medication). Participants will include 80 healthy adults between 18 and 40 years of age.~     Multiple blood draws will occur over the duration of the study. Participants will be involved~     in study related procedures for approximately 13 months.~   "
244964|NCT00347542|"~     The purpose of the study is to evaluate the change in glucose and insulin metabolism(early~     markers for development of diabetes) after 6 weeks of weekly Vitamin D supplementation. As~     vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we~     will also be measuring the changes in these variables.~   "
244965|NCT00347529|"~     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where~     administrations are given, any effects it may have on subjects' wellbeing and whether it can~     produce antibody responses in the body that may protect against the subjects catching a~     pandemic strain of flu~   "
244966|NCT00347516|"~     Implantation of an intraocular lens is the gold standard in modern day cataract surgery.~      The appropriate lens power needed to achieve the desired refractive outcome can be calculated~     with a whole variety of formulas.~      To date, there has been no prospective study conducted to evaluate the accuracy of the IOL~     power calculation formulae commonly in use. It is well established that the frequently used~     IOL formulas do not show significant differences when used in eyes of average axial length~     (i.e. between 22mm and 25mm) and it is at the extremes of axial lengths where discrepancies~     arise. Our aim is to find the most appropriate formula(e) for these 'long' and 'short eyes'~     particularly in our population where there is a significant proportion of high myopes.~   "
244967|NCT00347503|"~     Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition~     in human patients.~   "
244968|NCT00347490|"~     Primary objective:~      To assess clinical efficacy of single bolus anticoagulation with Enoxaparin in chronic~     hemodialysis~      Secondary objective:~      To assess safety and tolerability by the number of spontaneously reported adverse events by~     patients~   "
244969|NCT00347477|"~     Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a~     significant way. However hypothermia also causes leak of fluid into the surrounding tissue.~     This edema could lead to damage to the same tissue, not beneficial for the patients. We~     therefore try to evaluate if hyperosmolar, hyperoncotic fluid as an alternative to std.~     treatment (NaCl/RA)could affect the edema in a positive way, and result to a better outcome~     neurological for the patients.~   "
244970|NCT00347464|"~     Klinefelter syndrome, a congenital chromosomal abnormality with one or more extra X~     chromosomes, occurs in out of 400 live male births. The majority of Klinefelter men present~     with a 47, XXY karyotype. The poly-X variant, with the 49,XXXXY karyotype is uncommon. This~     syndrome, where subjects have two or more X chromosomes presents with primary hypogonadism,~     and, particularly if associated with the 49,XXXXY karyotype, significantly impacts life~     skills across a variety of dimensions, including areas of communication, community use,~     functional academics, home/school living, health and safety, leisure, self-care, self~     direction, and work. Adaptive behavior abnormalities in 46,XXY men are well known and~     described. In the poly-X variant of the 49,XXXXY karyotype, adaptive behavior abnormalities~     are expected to be much more significant, making these patients eligible for services and~     Social Security benefits.~      In 49,XXXXY men no study to date has examined these areas of inquiry in a large patient~     population, using a psychometrically sound instrument in a large patient population. Current~     publications are limited to individual case reports or small case summaries. It is important~     to study the adaptive behavior in its highly abnormal presentation in 49,XXXXY men in order~     to learn more about the effect of additional X chromosomes on adaptive skills, which~     determine how an individual responds to daily demands and in order to develop treatment and~     training goals.~   "
244982|NCT00347308|"~     Forehead and eyebrow surgery is a frequently performed cosmetic surgical procedure in which~     the eyebrows are raised to a more aesthetically pleasing position. Typically, this position~     is judged by the surgeon pre-operatively based on traditional aesthetic concepts, some of~     which date to the Classical era. This study is designed to assess the variance of the eyebrow~     from the desired aesthetic position (as determined by the subject), as wel as to assess the~     distance of normal excursion of the brow from maximum voluntary depression to maximum~     voluntary elevation.~   "
244983|NCT00347295|"~     To investigate the efficacy and safety of Brotizolam in the treatment of patients with~     insomnia in comparison with that of Estazolam~   "
244971|NCT00347451|"~     The prevalence of myopia in East Asia and Singapore in particular is amongst the highest in~     the world, with estimates ranging from 30-70% of the general population. Up to 30% of these~     are high myopes. High myopia is associated with degenerative changes in the fundus. It may~     also be associated with vision-threatening complications such as macular holes. The~     pathogenesis of macular holes in high myopes is not completely understood but is postulated~     to include a combination of anterior vitreous traction and posterior staphyloma formation and~     axial elongation. These forces lead to degenerative changes at the macula, including foveal~     detachment and retinoschisis that precede the formation of lamellar or full thickness macular~     holes. These changes are difficult to detect either clinically or by conventional imaging~     such as ultrasound, making efforts to correct them in the early stages with surgery~     difficult. High myopia is also associated with a two- to threefold increase in risk of~     developing glaucoma. However, the diagnosis of glaucoma in high myopes is difficult as many~     of the pathological changes in the myopic eye mimic those seen in glaucoma. The myopic optic~     disc in particular is notoriously difficult to differentiate from the glaucomatous disc.~     Currently, the diagnosis is highly subjective, relying on observations of the clinical~     appearance of the disc or on disc photos.Optical coherence tomography (OCT) is an evolving~     technology that relies on time delays of reflected or backscattered light and interferometry~     to yield cross-sectional images of the retina and optic disc. The Stratus OCT is the latest~     model and has been demonstrated to be able to yield images with a resolution comparable to~     that of histology. It is thus potentially useful in assessing degenerative changes occurring~     in the myopic fundus, in evaluating the early changes preceding macular hole formation, and~     in providing objective measures of various disc parameters to aid in diagnosing glaucoma in~     high myopes. This study aims to recruit 150 healthy, young, ophthalmologically normal males~     from the SAF and to examine them with OCT. High myopes (≤-8D) will be selected and compared~     with a control group of low myopes. The performance of the OCT will be evaluated against~     current diagnostic methods.~   "
244972|NCT00347438|"~     The purpose of this study is to assess the safety and effectiveness of capecitabine before~     surgery.~      The study will also help gain more information about the effects of the capecitabine on~     physical and emotional well-being and how well the participants on capecitabine follow the~     study drug plan.~   "
244973|NCT00347425|"~     The study will evaluate the safety and tolerability of switching subjects with schizophrenia~     or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.~   "
244974|NCT00347412|"~     The purpose of this clinical trial is to find out whether or not the combination of NOV-002~     with chemotherapy (paclitaxel and carboplatin) is better at improving overall survival time~     when compared to chemotherapy alone in people with non-small cell lung cancer (NSCLC).~      Earlier clinical trials in NSCLC showed that patients treated with NOV-002 in combination~     with chemotherapy had a better response (their tumors got smaller in one United States Phase~     1/2 trial) than patients who received chemotherapy alone; and in two Phase 2 trials done in~     Russian patients, at the end of one year, patients treated with NOV-002 with chemotherapy had~     a better survival rate than patients who did not receive NOV-002 with their chemotherapy.~   "
244975|NCT00347399|"~     The purpose of this study is to determine if of combination therapy of intravitreal~     bevacizumab 4 days after the application of photodynamic therapy could improve the visual~     outcomes of patients with neovascular age related macular degeneration.~   "
244976|NCT00347386|"~     Infections are the important cause of high mortality in young infants in developing~     countries. Zinc is a crucial micronutrient as it influences various immune mechanisms and~     modulates host resistance to several pathogens. It has shown benefits as an adjunct therapy~     in infections like diarrhea and pneumonia in older children Given the predisposition of young~     infants in developing countries to zinc deficiency and infections, addition of zinc to~     standard treatment of serious bacterial infections may lead to significant improvements in~     the outcomes.~      Several hypotheses will be examined in this clinical trial. The primary objective is to~     measure, in a double blind randomized controlled trial, the efficacy of giving 2 RDA~     (Required Daily Allowance 10 mg) of zinc orally in addition to routine antibiotics, for~     treatment of possible serious bacterial infection in infants >= 7 days and up to 4 months of~     age in reducing the proportion of treatment failures and time to discharge from the hospital.~     This will evaluate the clinical consequences of the possible immunomodulation by zinc~     supplementation. This is critical to demonstrate because nearly 80% of infant mortality~     occurs in first months of life.~      Young infants with possible serious bacterial infections fulfilling the inclusion criteria~     will be enrolled in the study and stratified into 4 groups on basis of weight for age 'z'~     scores < -2 z and >=- 2 z and whether he/she has diarrhea or not. Within each stratum the~     subjects will be randomized to receive zinc or placebo. Treatment failures will be defined by~     the need for a change of initial antibiotic therapy. The minimum duration of monitoring will~     be till clinical recovery (using predetermined criteria). Serum copper, serum ferritin and~     serum transferrin receptors will be determined at enrollment, 72 hours after enrollment and~     at discharge from the hospital. Concentrations of CRP and procalcitonin will be measured at~     baseline, 72 hours after enrolment and at clinical recovery.~      Documentation of efficacy of addition of zinc to standard therapy may provide a simple and~     low-cost strategy to improve survival in serious infections in young infants. This is likely~     to have a significant impact on infant morbidity and mortality. It will be good example of~     using a simple immunomodulator beneficially in improving child health.~   "
244977|NCT00347373|"~     The purpose of this clinical trial is to examine the effects of a low and high dose of~     conjugated linoleic acid supplement on body composition in obese humans. Individuals with a~     body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gCLA, or~     6.4g CLA daily for twelve weeks. Changes in body composition, weight, and clinical laboratory~     values are compared between the three groups.~   "
244978|NCT00347360|"~     This is a randomized, double-blind, double-dummy, parallel group trial employing 15 cells of~     a 4x4 factorial design (no placebo)to compare the hypertensive effects in patients with Stage~     1 and Stage 2 hypertension of carvedilol (20, 40 or 80 mg daily) alone, lisinopril (10, 20 or~     40 mg daily) alone, and all combinations of the doses.~   "
244979|NCT00347347|"~     A thorough ophthalmic examination of a child must include a refraction and this is often done~     with cycloplegia. In our study, we aim to determine at which age group a non-cycloplegic~     refraction technique closely correlates with a cycloplegic refraction and hence, would~     obviate the need for cycloplegic refraction in our routine clinical practice.~   "
244980|NCT00347334|"~     The term torticollis is Latin for twisted neck. It can be caused by a tightness of the~     sternocleidomastoid muscle manifested by a head tilt to the same and neck rotation to the~     opposite side. Treatment includes a comprehensive physical therapy program. Torticollis~     typically presents itself within the first three months of life. Currently research in~     infants concludes that a physical therapy stretching program is effective in the majority of~     cases.1~      The study will determine how positioning time correlates to rate of recovery. Overall~     incidence of torticollis has increased dramatically since the inception of the back to sleep~     program in 1994.2 The back to sleep program is an educational awareness program promoting~     families to place infants to sleep on their backs to reduce the risks of sudden infant death.~     The increase use of semi-upright positioning equipment prior to developmental head control~     may also be contributing to the increase. Families are placing babies in semi-upright~     position ie. car seat or swing prior to developmental head control. Head control typically~     emerges by three months of age. Unfortunately the use of positioning devices occurs prior to~     the child reaching their third month birthday.~      The specific aims of the study will include measuring the rate of recovery for infant~     torticollis. Recovery will be defined as achieving full neck rotation and no head tilt. The~     length of time spent in developmental positions and positioning equipment such as belly~     lying, side lying, semi-upright and sitting will also be monitored and recorded. No specific~     position will be prescribed; the study will monitor positions only.~      Treatment will be initiated upon referral to Cleveland Clinic Children's Hospital for~     physical therapy evaluation. Baseline for cervical rotation and lateral tilt will be~     assessed. Families will be trained regarding a home stretching program and asked to diary~     home positioning time. Routine plan of care will continue a minimum of every other week until~     full active range of motion is achieved. At each visit cervical range of motion will be~     determined as well as parent report regarding home positioning time. Recovery will be defined~     as full active range of motion, no head tilt, and symmetrical head righting reactions. Post~     recovery analysis of recovery rates and positioning time will be done to assess correlations.~   "
244984|NCT00347282|"~     Superior sulcus deformity in post-enucleation socket syndrome (PESS) may pose a significant~     cosmetic blemish after enucleation surgery despite apparently adequate orbital volume~     replacement. The underlying reasons include the lack of accurate pre-operative volumetric~     assessment of the anophthalmic socket, leading to either under or over estimation of the~     orbital implant required and the shifting in orbital and periocular structures that may occur~     post enucleation. Conventional imaging studies (computed tomography and magnetic resonance~     imaging) have been used to study the anatomy of anophthalmic sockets, but there are several~     drawbacks such as poor image quality for detailed volumetric assessment, long exposure time~     with possible motion artifact and etc. The new multi-detector computed tomographic technology~     is the latest advance in diagnostic radiology that allows rapid high resolution images to be~     obtained for three dimensional reconstruction and volumetric assessment. This new imaging~     modality will contribute greatly to the understanding of PESS and the surgical planning of~     anophthalmic sockets reconstruction.~      This is a pilot study aiming to collect clinical data on the volumetric and structural~     changes in PESS. The information obtained will:~        1. allow more accurate volume estimation of the primary orbital implants prior to~          enucleation surgeries, thus minimize the development of PESS;~        2. evaluate the volumetric & structural anomalies that constitute PESS~        3. be used for the development of a new customized secondary orbital implant to manage~          superior sulcus deformity in PESS.~   "
244985|NCT00347269|"~     This study will compare the effectiveness of an intervention strategy for the treatment of~     people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and~     social anxiety disorder in the primary care setting.~   "
244986|NCT00347256|"~     The purpose of this study is to determine the efficacy of concurrent chemotherapy and~     radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main~     objectives of this study are: 1) to measure the rate of complete response to preoperative~     chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and~     surgery in terms of local control of the cancer two years post treatment.~   "
244987|NCT00347243|"~     Purpose:To compare visual performance, total and high order wavefront aberrations (coma,~     spherical aberration and other terms) and contrast sensitivity in eyes implanted with one~     monofocal aspheric intraocular lens (IOL) and two spherical IOLs (SofPort AO,~     Soflex,AcrySof®IQ (40 eyes), AcrySof®Natural and AMO®Sensar)~   "
244988|NCT00347230|"~     To study the effects Intacs intracorneal ring segments(Addition Technology, Inc) insertion in~     the treatment of keratoconus~   "
244989|NCT00347217|"~     Observational study to investigate the use and efficacy of CRESTOR 5 mg in reaching LDL-C~     target goals in both statin naïve and statin treated primary and secondary prevention~     patients at high risk for a cardiovascular event.~   "
244990|NCT00347204|"~     To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS &~     Nevanac) to help control pain following Photorefractive Keratectomy (PRK).~   "
244991|NCT00347191|"~     The purpose of this study is to evaluate the relationship between intraocular pressure and~     central corneal thickness using various instruments in ocular hypertension, normal-tension~     glaucoma, primary open angle glaucoma, keratoconus and normal eyes.~   "
244992|NCT00347178|"~     This is a multicentric, randomised, controlled study comparing Laser Iridotomy (LI) to no~     treatment in subjects with asymptomatic narrow angles (ANA).One eye of each subject with ANA~     will be randomised to undergo LI and the other eye will be left alone and will serve as an~     internal control. Subjects are proposed to be followed up once a year for 5 years.~   "
244993|NCT00347165|"~     The purpose of this study is to determine whether intravitreal injection of bevacizumab is~     effective in the treatment of neovascular age related macular degeneration~   "
244994|NCT00347152|"~     The purpose of this study is to determine whether there is any difference in side effects~     experienced by individuals with intellectual disorders taking Depakote DR (immediate release~     form) when they are switched to the extended release form (ER) overnight versus when they~     switch more gradually over a week.~   "
244995|NCT00347139|"~     In order to obtain information on a wider range of doses of GW642444 (a possible new~     medication to treat asthma) than has been previously examined in asthmatic patients, this~     current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be~     compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar~     manner to a study that has already been completed (study number B2C101762) which examined~     repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data~     from study B2C101762 and will provide confidence (or not) that the desired bronchodilation~     can be achieved and maintained without undesirable side effects.~   "
244996|NCT00347126|"~     Prostaglandin analogs are a leading class of glaucoma drugs with a proven safety and efficacy~     for controlling IOP. They include latanoprost, bimatoprost, travoprost and unoprostone.~     Recently, the Singapore National Eye Center (SNEC) awarded a tender for prostaglandin~     analogues to Alcon, the manufacturer of travoprost. Since then, all subsidized patients~     previously treated with latanoprost were systematically switched to travoprost and this~     process will continue for the rest of this year. In this study, we propose to prospectively~     study the efficacy and safety of switching from latanoprost to travoprost in a large series~     of glaucoma patients at SNEC. A total of 372 consecutive patients being switched from~     latanoprost to travoprost will be followed up for 12 weeks following the switch. In addition~     to intraocular pressure, the safety and tolerability (with particular emphasis on hyperemia)~     of travoprost will be examined.~   "
245011|NCT00346931|"~     The purpose of the study is to determine whether combined cataract and glaucoma surgery~     (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery~     alone in patients with borderline control of intraocular pressure.~   "
245012|NCT00346918|"~     The aim of our study is to investigate whether Rapamune used at a low dose (2 mg/d) retards~     cyst growth and slows renal functional deterioration in patients with ADPKD.~   "
245013|NCT00346905|"~     The study objective is to assess the long term safety and effectiveness of Enteryx device in~     commercial use. The long-term effects beyond one year of treatment with Enteryx have not been~     established.~   "
246014|NCT00333268|"~     The purpose of this study is to determine the safety and efficacy of Next Generation~     Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract~     extraction and intra-ocular lens (IOL) implantation.~   "
244997|NCT00347113|"~     The proposed study has as the main objective to investigate the effect of schistosome and STH~     infections and the effect of an anthelminthic intervention on P. falciparum malaria, related~     anaemia and malaria antibody responses among school and pre-school children in Mwanza,~     Tanzania. The study will include a cross-sectional baseline survey followed by an~     anthelminthic intervention trial of two years duration. At baseline, prevalence and intensity~     of malaria, schistosome and STH infections and the prevalence of anaemia will be determined~     by examination of blood, faecal and urine samples. Spleen and liver size and consistency will~     be determined by palpation. P. falciparum specific antibodies will be determined by ELISA.~     All children will be treated with a single dose of praziquantel 40mg/kg and albendazole~     400mg. Children selected to participate in the intervention trial will be randomized into two~     groups, an intervention group of 258 children which will be followed up with albendazole~     400mg and praziquantel 40mg/kg at three months interval and a control group of 258 children~     which will be followed up with praziquantel 40mg/kg and albendazole 400mg once a year in~     accordance with the National Schistosomiasis and Soil-transmitted Helminths Control~     Programme. At 12 months and 24 months follow-up, all examinations conducted at baseline~     survey will be repeated.~   "
244998|NCT00347100|"~     Primary:~        -  To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline~          to endpoint A1c < 7%)~      Secondary:~        -  To investigate the safety of insulin glargine (in terms of hypoglycaemia, including~          symptomatic, non-symptomatic and nocturnal hypoglycaemia)~        -  To investigate whether beta cell function is preserved if this therapy is initiated~          before 2nd OAD (oral anti-diabetic drug) failure~   "
244999|NCT00347087|"~     To test whether treatment with the angiotensin II receptor antagonist Irbesartan improves~     insulin sensitivity and metabolic profile in patients with chronic heart failure.~   "
245000|NCT00347074|"~     A clinical study of keratoconus in Asian Patients and assessment of different topographic~     patterns of keratoconus in Asian patients~   "
245001|NCT00347061|"~     Primary:~      To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients~     with lower urinary tract symptoms related to BPH.~      Secondary:~        -  To provide the information on the efficacy of SL77.0499-10 10mg administered once daily~          for one year in patients with lower urinary tract symptoms related to BPH.~        -  To document the plasma concentration of SL77.0499-10 after repeated administration of~          SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms~          related to BPH.~   "
245002|NCT00347048|"~     This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in~     moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of~     12-week open-label efficacy and safety study in responders.~   "
245003|NCT00347035|"~     Purpose:~      To evaluate the influence of the nonsteroidal anti-inflammatory indomethacin on the~     brimonidine intraocular pressure (IOP) lowering effect.~      Methods:~      A randomized double-masked study was carried out. Patients medicated with timolol maleate~     0,5% and needed complementary medication were random allocated into two groups: (a)~     brimonidine tartarate 0,15% and indomethacin 1% or (b) brimonidine tartarate and placebo~     (balanced saline solution). If patient’s both eyes were eligible, they were allocated to the~     same group.~      IOP was measured at two weeks, one month and two months after study beginning. The mean IOP~     of the eyes was used for analyzes, in the case of two eligible eyes. For statistical analyzes~     repeated measures analysis was used.~   "
245004|NCT00347022|"~     This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric~     indications.~   "
245005|NCT00347009|"~     This 36-month open-label study of adefovir dipivoxil investigates the clinical benefits of~     the therapy in chronic hepatitis B patients with advanced fibrosis or cirrhosis confirmed~     with biopsy. Primary endpoint is histological improvement defined as a decrease of Ishak~     Fibrosis Score by one point or more from baseline at Month 36 of adefovir dipivoxil~     treatment. Approximately 150 patients will be recruited in study centres in the Asia Pacific~     area. The patients are offered 36 months of open label adefovir dipivoxil treatment, with~     assessments every three months, after which there is a 6-month post study treatment follow-up~     prior to study completion. After the 36 months of study treatment, it is likely that the~     patient will benefit from continued treatment with adefovir dipivoxil. If this is the case in~     the investigators clinical judgement, the investigator should ensure that a routine~     prescription is available in a timely manner, and that no unnecessary interruption in~     treatment occurs.~   "
245006|NCT00346996|"~     Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the~     occurrence of severe hypoglycaemia during two different insulin regimens are to be~     investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised~     to receive analogue and human insulin for one year in random order. Outcomes will be number~     of episodes of severe hypoglycaemia~   "
245007|NCT00346983|"~     This research is being conducted to look at the effects of an intraocular drug (pegaptanib,~     also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue~     in the back of the eye) that often occurs following cataract surgery in patients with~     diabetic eye disease. Swelling in the retina can lead to blurry vision, and Macugen may~     reduce this swelling. Eyedrops that decrease inflammation also may help to stop some of the~     swelling. We are testing this drug (pegaptanib) to see if it can decrease swelling in the~     retina and improve vision in patients with diabetes who are having cataract surgery.~   "
245008|NCT00346970|"~     The aim of the present study is to characterize novel mechanisms whereby HDL may exert potent~     vasculoprotective effects independent of reverse cholesterol transport, in particular the~     effect of HDL on the regulation of the vascular NAD(P)H oxidase enzyme system, a major~     vascular source of superoxide, known to be important for endothelial dysfunction. In~     addition, the present study will characterize the effect of HDL on endothelial progenitor~     cell (EPC) mobilization, nitric oxide production and in vivo regenerative capacity.~   "
245009|NCT00346957|"~     The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg~     versus placebo) that is safe and effective for the inhibition of the growth of blood vessels~     in the retina in patients with wet AMD.~   "
245010|NCT00346944|"~     The aim of the project is to study changes in symptom load after removal of all dental~     amalgam restorations in patients with symptoms allegedly related to amalgam.~   "
245014|NCT00346892|"~     The primary objective of this study was to demonstrate that co-administering HRV vaccine~     with OPV does not induce a significant decrease in poliovirus immune response one month after~     the third dose of combined vaccines.~      The primary objective was reached if one month after the third dose of polio vaccine, upper~     limit of the 95% CI for the difference in Seroprotection rate between the group B and C~     pooled and (minus) the group A was below 10% for each polio serotype.~   "
245015|NCT00346879|"~     This is a prospective open-label study comparing two dosing regimens of fondaparinux, which~     is used to prevent deep vein thrombosis, in morbidly obese volunteers.~   "
245016|NCT00346866|"~     The purpose of this study was to evaluate the efficacy of anecortave acetate for depot~     suspension (30 mg and 15 mg) plus PDT versus PDT alone with respect to maintenance of visual~     acuity in patients with wet AMD.~   "
245017|NCT00346853|"~     The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP,~     fomepizole, Antizol™) inhibits dark adaptation of the eye. In other words, we are testing if~     4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these~     processes, individuals with Stargardt disease may have better chances of saving their~     remaining vision. 4-MP has been shown to slow dark adaptation in animals, and is FDA approved~     for human use to treat individuals with methanol or ethylene glycol (antifreeze) poisoning by~     shutting down the body's ability to process alcohols. This medication has an excellent safety~     profile and has been reported to have no short-term or long-term side effects, as long as~     patients refrain from any alcohol while the medication is in the body. A single dose of 4-MP~     remains in the body for about 12 hours, and therefore, it may inhibit dark adaptation of your~     eyes for up to 12 hours. Studying the effects of 4-MP may lead to effective medical treatment~     to save Stargardt patients' vision, and may also have similar effects in other macular~     degenerative diseases.~   "
245018|NCT00346840|"~     The primary objective of the study was assessment of the efficacy of four dose reservoirs (25~     mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered~     for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal~     delivery.~   "
245019|NCT00346827|"~     To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in~     subjects with Parkinson's Disease.~   "
245020|NCT00346814|"~     Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in~     children. Although ablation of the retina with laser or cryotherapy reduces the incidence of~     blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are~     often poor. Vascular endothelial growth factor(VEGF) has an important role in the~     pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent~     destructive neovascularization in ROP. The aim of this study is to determine the safety and~     efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity~   "
245021|NCT00346801|"~     Primary Objectives:~        -  To determine the feasibility, activity, and toxicity of a novel regimen using a~          concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with~          unresectable NSCLC.~        -  To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC~          treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.~        -  To correlate the COX-2 expression and other biomarkers with response to the treatment in~          the tumor from a pretreatment biopsy specimen.~   "
245022|NCT00346788|"~     The purpose of this study is to determine if the observed benefits of minimally invasive~     total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be~     achieved with standard knee arthroplasty using the subvastus approach.~   "
245023|NCT00346775|"~     The Protocol section needs to be updated using the following text The main goal of the study~     was to validate the Preference Module of the EARNS-Q and to test the reliability using~     Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for~     determining satisfaction among different treatment. The EARNS-Q is divided into 2 modules, an~     Experience Module and a Preference Module. The Experience Module includes 28 items, fourteen~     attribute rating items followed by fourteen importance weighing questions. The Preference~     Module includes the same items along with preference questions related to each item as well~     as a global preference question.~   "
245024|NCT00346762|"~     HIV infected former commercial blood donors (FBDs) in Fuyang, Anhui Province, China were~     infected with HIV from a common-source exposure to contaminated blood. The purpose of this~     study is to examine the role of host and viral factors in HIV disease progression in this~     unique HIV infected population.~   "
245025|NCT00346749|"~     This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary~     Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will~     stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects~     who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits.~     Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing~     tests and will complete diary cards during the study. All study medicines and examinations~     will be given at no cost to the study subjects. Both medicines used in this study have been~     approved by the US FDA.~   "
245038|NCT00346580|"~     Sepsis is the leading cause of death in critically ill patients in the United States. It~     develops in approximately 750,000 Americans annually, and more than 210,000 of them die.~     Despite improvements in supportive treatment, mortality has changed very little, and until~     recently, no sepsis-specific treatments were available. Protease inhibitors have seemed to~     have an immune benefit that extends beyond their ability to prevent HIV replication. T cells~     in those patients treated with protease inhibitors have reduced rates of death than in those~     patients not receiving therapy.~   "
245039|NCT00346567|"~     The aim of the study is to find short course alternatives to single dose (sd)nevirapine for~     the prevention of mother-to-child HIV-transmission with the same or better degree of~     transmission protection than sd nevirapine but with less NNRTI resistance development.~   "
245069|NCT00346151|"~     Belatacept is an experimental medication shown in clinical trials to have immune system~     suppression properties in people who have had renal (e.g., kidney) transplants. This study~     will determine whether a combination of anti-rejection drugs, including belatacept, can~     prevent the rejection of a first-time, non-human leukocyte antigen (HLA) identical renal~     transplant and allow patients to be safely withdrawn from anti-rejection therapy one year~     post-transplant.~   "
245026|NCT00346736|"~     Autism is a behaviorally defined, lifelong disorder of the brain, affecting at least 1-2 per~     1000 children. There is an increasing trend of autism worldwide. However, to date, there is~     still no cure for this devastating childhood disease. Autism is characterized by deficit in~     language, social communication and repetitive behavior. It is estimated that the annual cost~     of care for autism is $13 billion in USA alone. Children with autism usually have associated~     behavioral problems such as aggressiveness, stereotypes, hyperactivity, emotional lability,~     and short attention span.~      The National Institute of Child Health & Human Development and National Institute of Deafness~     & Communication Disorders have jointly founded the Collaborative Programs of Excellence in~     Autism. One of the long-term NIH goals is to develop or refine interim treatment strategy and~     to develop effective biological, behavioral or alternative treatment strategy for autism.~     There is a dire need for early identification and treatment of children with autism.~      Acupuncture has been practised in China for 2 millennia. The legal status of acupuncture as a~     treatment technique was approved by Food & Drugs Administration in USA (1997). The~     therapeutic effect of acupuncture is based on stimulation at specific acupoints resulting in~     both local and distant effect via improving signal or modulation of electromagnetic energy.~     There had lack of studies of acupuncture in autism. We hope that we can study the efficacy of~     acupuncture in autism using clinical measurement. We hope to identify the role of acupuncture~     as an adjunctive treatment for autism.~   "
245027|NCT00346723|"~     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in~     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of~     these vaccines are required to be involved in ongoing clinical trials and to present the~     results to the competent authorities each year. The current study is a phase IIIa clinical~     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It~     is part of the ongoing clinical trial program for Influvac® and will be done to assess the~     immunogenicity and safety and tolerability of next season's trivalent influenza subunit~     vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects~     >= 61 years of age (elderly).~   "
245028|NCT00346710|"~     Information was entered by mistake by a Research Assistant. Study never went beyond the~     initial discussion phase.~   "
245029|NCT00346697|"~     The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in~     HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will~     evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and~     inflammation.~   "
245030|NCT00346684|"~     First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in~     clinical stage IA using the monoclonal anti-CD20 antibody rituximab~   "
245031|NCT00346671|"~     Complementary therapies such as Reiki are becoming popular. Reiki is a practice used for~     relaxation and pain management that involves physical touch and social contact with a~     trained, empathetic practitioner. Unlike many relaxation therapies, Reiki requires no~     participation by the patient, a feature that makes Reiki particularly attractive in the~     hospital setting, where patients are often extremely anxious, depressed, in pain, or sedated.~     Our primary research questions are to determine whether physiological changes are induced~     during a Reiki session and whether a Reiki session affects responses to a subsequent acute~     stressor. Secondary research questions include assessing which benefits result from placebo~     or unique abilities of attuned Reiki practitioners and assessing background characteristics~     of recipients that are associated with acceptance and responsiveness. Based on its use to~     reduce pain and anxiety, we will study potential mechanisms by which Reiki decreases activity~     of the sympathetic nervous system and other stress pathways. Comparison of the responses in a~     Reiki group with those in supine-control and sham groups will allow us to gain insights into~     mechanisms by which Reiki effects are mediated. Information obtained from the proposed~     studies will provide detailed information on physiological pathways affected by Reiki. Should~     Reiki decrease stress pathways or reduce physiological responses to stressful situations, it~     could be a useful adjunct to traditional medicine and have significant health and economic~     benefits.~   "
245032|NCT00346658|"~     Extreme magnesium deficiency is known to have an impact on the synthesis, secretion and/or~     action of calcium regulating hormones. Many older adults are at risk for less severe~     magnesium deficiency, since the majority of adults receive less than the Recommended Daily~     Allowance of magnesium. We hypothesize that magnesium supplementation will have a beneficial~     effect on calcium regulating hormones and markers of bone turnover.~   "
245033|NCT00346645|"~     The purpose of this study is to determine whether Bortezomib is effective in the treatment of~     patients with non-small-cell lung cancer who have not received any prior chemotherapy regimen~     for advanced disease.~   "
245034|NCT00346632|"~     Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in~     subjects with AML, ALL, MDS and CML.~   "
245035|NCT00346619|"~     Our group has shown that HAART increases the thymic production of naïve T cells in the~     healthy adult, thereby boosting the immune system. We propose to investigate the amount of~     and length of Nelfinavir therapy necessary to increase those cells in adults. Subjects will~     be treated with Nelfinavir, and blood will be sampled at variable times to determine the~     immune response in peripheral blood.~   "
245036|NCT00346606|"~     Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg~     (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.~      Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.~      Primary end point: To evaluate the change in average AM/PM reflective pruritus score from~     baseline recorded in the subjects’ diaries during the first two weeks of the treatment.~      Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and~     levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.~   "
245037|NCT00346593|"~     The primary purpose of this study is to investigate the clinical performance of a new~     silicone hydrogel contact lens during continuous wear (up to 30 nights) over a period of 24~     months.~   "
245085|NCT00345930|"~     The purpose of this study is to identify individuals who have suffered a liver injury arising~     as an idiosyncratic reaction to a prescription drug or a complementary and alternative~     medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also~     added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic~     subjects.~   "
245040|NCT00346554|"~     The goal for COPD patients in pulmonary rehabilitation programs is to improve the quality of~     life. COPD is known to be worse at night as are other respiratory problems such as CHF.~     Saturation is known to get worse nocturnally as well. Furthermore, these COPD rehabilitation~     patients tend to be older and increasing age is associated with an increase in the incidence~     of sleep disorders. We suspect that there is an increase in the incidence of sleep disorders~     in COPD patients. We plan to further study these patients using questionnaires. A preliminary~     study was done, but the results were not comparable to national statistics. We plan to repeat~     the study, only changing the questions to a format comparable to data from the National Sleep~     Foundation.~   "
245041|NCT00346541|"~     Glaucoma, an optic neuropathy characterized by progressive visual field loss, is the leading~     cause of irreversible blindness worldwide. The condition has a substantial heritable basis,~     as illustrated by the numerous loci and genes identified to date, and the large proportion of~     patients having a family history.~      Interleukin-1 (Il-1) is an important mediator of inflammation. There are 2 pro-inflammatory~     cytokines, Il-1 alpha and Il-1 beta. The genes encoding Il-1 are located within a 430kb~     region on chromosome 2q14.2. The role of Il-1 in glaucoma is a subject of recent interest. It~     has been shown that Il-1, produced endogenously by glaucomatous cells, inhibits the apoptotic~     response to oxidative stress, and Il-1 has also been reported to increase outflow facility by~     stimulating the _expression of matrix metalloproteinase enzymes, which in turn reduces extra~     cellular resistance. Recently, polymorphisms in Il-1 (particularly +3953T of the Il-1 β) were~     found to reduce the risk of primary open angle glaucoma. In this pilot study, we aim to~     investigate the role of Il-1 polymorphisms in both normal tension and high pressure glaucoma~     in our glaucoma patients. Both open and closed angle glaucoma will be studied. This is a~     pilot study of the role of immune system related polymorphisms and depending on the results,~     we may embark on a larger investigation of other immune genes in glaucoma~   "
245042|NCT00346528|"~     To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus~     for use during cataract surgery in Pediatric patients.~   "
245043|NCT00346515|"~     Multicenter, prospective, feasibility study designed to demonstrate the performance and~     safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive~     device during carotid artery percutaneous intervention using the Guidant Acculink carotid~     stent in high surgical risk patients.~   "
245044|NCT00346502|"~     The purpose of this study is to evaluate the safety and effectiveness of an experimental 20%~     betulinic acid ointment (BA ointment) as a treatment for dysplastic nevi with the potential~     to transform into melanoma.~   "
245045|NCT00346489|"~     A clinical trial to establish the long term response of using intraoperative 5-fluorouracil~     (5-FU) versus mitomycin C (MMC) in trabeculectomy glaucoma surgery. Antiproliferative agents~     such as 5-fluorouracil and Mitomycin C have been used extensively in trabeculectomy surgery~     to improve the success of the surgery and prevent further visual loss and blindness in~     glaucoma patients.~   "
245046|NCT00346476|"~     The purpose of this study is to determine the number of people infected with tuberculosis~     (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of~     TB and HIV. This study will also examine the genetics of TB and the relationships among~     active TB infection, new HIV infections, and HIV disease progression.~   "
245047|NCT00346463|"~     Growth retardation in utero may be caused by uteroplacental vascular insufficiency. When~     Doppler ultrasound studies of the umbilical artery are abnormal pathological intrauterine~     growth restriction (IUGR) can be diagnosed. IUGR fetuses have a higher mortality and~     morbidity, both perinatally and on the longer term. This is probably due to chronic~     malnourishment and hypoxia due to placental insufficiency. This placental dysfunction causes~     generation of harmful free oxygen radicals in the fetus. The IUGR fetus has a diminished~     antioxidative capacity which means these free radicals cannot be buffered sufficiently. This~     leads to fetal oxidative stress.~      Previous studies have shown that allopurinol can inhibit the cascades that lead to generation~     of free radicals. High dosed allopurinol also scavenges radicals and binds free iron without~     adverse effects on the fetus or mother.~      As IUGR is associated with placental insufficiency and excessive production of free radicals~     we hypothesize that antenatal allopurinol administration could lead to a decrease in~     oxidative stress in the mother and fetus and subsequent improvement of the maternal and/or~     neonatal outcome.~   "
245048|NCT00346450|"~     To evaluate the use of cultivated conjunctival epithelial equivalents for the treatment of~     ocular diseases~   "
245049|NCT00346437|"~     The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4~     is effective in improving exercise capacity measured by exercise treadmill testing, angina~     functional class, patient symptoms, quality of life, and cardiovascular outcomes. Two doses~     will be studied, 2.87 x 10(8) and 2.87 x 10(9) viral particles, to evaluate the dose-response~     of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.~   "
245050|NCT00346424|"~     The purpose of the study is to compare the safety and effectiveness of alfimeprase to a~     placebo in restoring function of occluded central catheters.~   "
245051|NCT00346411|"~     This research is being done to help us learn about how different factors related to treatment~     affect rheumatoid arthritis (RA). This is not a treatment study. We will follow the patient~     for one year as he or she receives usual treatment from his or her rheumatologist. Up to 360~     adults with RA may join this study.~   "
245052|NCT00346398|"~     The purpose of this study is to determine whether early childhood exposure to common~     allergens (substances that can trigger allergies and asthma) can prevent the development of~     asthma in children at high risk for developing the disease.~   "
245053|NCT00346385|"~     RATIONALE: Monoclonal antibodies, such as BB-10901, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them.~      PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in~     treating patients with relapsed or refractory solid tumors.~   "
245054|NCT00346372|"~     During regularly scheduled appointments, Optical Coherence Tomography (OCT) is performed on~     consented subjects. The OCT is a new type of camera that takes very detailed pictures inside~     of the eye and deeper into eye tissues. Optical Coherence Tomography imaging of intraocular~     tumors may lead to improved diagnosis and monitoring of tumors within the eye.~   "
245055|NCT00346359|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor~     peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also~     stops the patient's immune system from rejecting the donor's stem cells. The donated stem~     cells may replace the patient's immune system and help destroy any remaining abnormal or~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving antithymocyte globulin,~     tacrolimus, and methotrexate before or after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan~     followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and~     methotrexate works in treating patients with myeloid cancer.~   "
245056|NCT00346346|"~     This study will examine the immune response to the malaria parasite at the cellular level to~     better understand why people achieve natural immunity to the parasite only after multiple~     infections and why immunity diminishes rapidly in the absence of ongoing infection. The~     results of this study may provide insight into whether and how natural immunity can be~     improved upon by vaccination.~      Healthy people 2-4 and 18-25 years of age who live in the village of Kambila, Mali, may be~     eligible for this 1-year study. Participants have a small blood sample collected from a vein~     in the arm and also from two finger pricks at the beginning of the study, then every 2 months~     for 6 months and at the end of the study (for a total of five samples). People who become ill~     with malaria are evaluated and treated by a physician. Those recovering from their first~     episode of malaria during the study period have another blood sample collection and two~     finger pricks (bringing to six the total number of samples collected).~   "
245057|NCT00346333|"~     The purpose of this trial is to determine whether lutein in addition to vitamin A will slow~     the course of retinitis pigmentosa.~   "
245058|NCT00346320|"~     RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may~     kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase II trial is studying how well radiation therapy works in treating~     patients with stage I or stage II non-small cell lung cancer that cannot be removed by~     surgery.~   "
245059|NCT00346294|"~     An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™~     Auto-injector in RA subjects.~   "
245060|NCT00346281|"~     This is the first study investigating the safety of 32P BioSilicon in patients with~     advanced,unresectable pancreatic cancer who are also receiving standard intravenous~     gemcitabine chemotherapy. The secondary aims of the study will assess the implantation~     procedure, localisation of 32P BioSilicon, tumour response and survival parameters.~      Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume~     and with the low radioactivity dose that is delivered intratumourally, the incidence of side~     effects associated with the treatment is expected to be low. Prologation of survival and~     improved quality of life could be favourable outcomes of the investigational product.~   "
245061|NCT00346268|"~     The primary objective of this study is to demonstrate the opioid-sparing efficacy of~     parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the~     24 hours after the end of surgery.~   "
245062|NCT00346255|"~     RATIONALE: Monoclonal antibodies, such as BB-10901, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them.~      PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in~     treating patients with relapsed and/or refractory multiple myeloma.~   "
245063|NCT00346242|"~     The evaluation of efficacy is performed by laboratory monitoring of bone density and~     resorption markers and clinical monitoring of bone density improvement. This is a~     prospective, randomized, parallel group, single blind study of one year treatment with~     zoledronic acid every 6 months as compared to one year treatment with zoledronic acid every 3~     months and to placebo every 3 months in patients with hemoglobin syndromes and risk of~     skeletal complications.~   "
245064|NCT00346229|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above~     normal body temperature. Giving temperature-sensitive liposomal doxorubicin together with~     hyperthermia may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     temperature-sensitive liposomal doxorubicin when given together with hyperthermia in treating~     women with locally recurrent breast cancer.~   "
245065|NCT00346216|"~     To answer the question of overall benefit: risk of celecoxib when compared to two most~     commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs)~     in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or~     rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited.~     The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each~     treatment group will be assessed accordingly.~   "
245066|NCT00346190|"~     To determine whether administration of Alendronate early is more effective than late in the~     prevention of osteoporosis following a hip fracture~   "
245067|NCT00346177|"~     The purpose of this study is to determine if cell therapy with your own cells (autologous~     cells) delivered with a catheter to regions of the heart with poor blood flow will be safe~     and if it will improve your ejection fraction and heart failure symptoms.~   "
245068|NCT00346164|"~     This phase III trial is studying observation to see how well a risk based treatment strategy~     works in patients with soft tissue sarcoma. In the study, patients are assigned to receive~     surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes,~     after surgery, the tumor may not need additional treatment until it progresses. In this case,~     observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed. Giving these treatments~     after surgery may kill any tumor cells that remain after surgery.~   "
245070|NCT00346138|"~     The objectives of this study are to compare the visual and refractive outcomes of deep~     lamellar endothelial keratoplasty (DLEK) with penetrating keratoplasty as treatment for~     certain cases of corneal edema due to endothelial decompensation. Additionally, data will be~     collected to compare corneal shape, corneal thickness, endothelial cell density, keratocyte~     density, corneal sensitivity, light scatter, and subjective visual function between the two~     procedures.~   "
245071|NCT00346125|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) scan and~     computated tomography (CT) scan, may help doctors predict a patient's response to treatment~     and may help plan the best treatment. Drugs used in chemotherapy, such as doxorubicin and~     ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving chemotherapy before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This clinical trial is studying how well PET scan combined with CT scan predicts~     response in patients undergoing chemotherapy and surgery for soft tissue sarcoma.~   "
245072|NCT00346112|"~     RELAX-ICD Trial/Research Study; Quality of Life/Protocol No.P-KARE-01: A 3-month outpatient~     rehabilitation therapy and psychological counselling including informative talks with~     conventional therapy, by a cardiologist or general practitioner after implantation of an~     internal cardioverter defibrillator (ICD) in adult patients, whereby the effects of three~     different strategies are compared. Study hypothesis: the rehabilitation programme will be~     beneficial in the management of any psychological problems possibly as a result from the~     intervention, and will help to overcome anxiety, and contribute to improved quality of life.~   "
245073|NCT00346099|"~     Panitumumab is a monoclonal antibody. It works by attaching to a protein called epidermal~     growth factor receptor found on normal and cancer cells. When panitumumab attaches, it blocks~     another protein called epidermal growth factor (EGF) from attaching to the cell. This is~     important because, when EGF is blocked, a cell's growth slows down or stops. Panitumumab may~     also help radiation therapy work. Also because panitumumab is a fully-human antibody, it may~     be less toxic than other monoclonal antibodies made to block the EGF receptor. Chemotherapy,~     such as capecitabine and oxaliplatin, works to kill cancer cells directly. Capecitabine given~     during radiation helps radiation therapy work better. This study is being done to learn how~     rectal cancer tumors that are not removed surgically respond to treatment with panitumumab~     and chemotherapy given before radiation therapy begins followed by treatment with panitumumab~     and capecitabine given with radiation therapy.~   "
245074|NCT00346086|"~     Various chemical modifications of allergens have been attempted to enhance efficacy, improve~     safety, and foster compliance with IT. These approaches have been unsuccessful - in that the~     allergenicity and immunogenicity have either decreased, or increased in tandem, with no~     resultant efficacy: safety benefit ratio. This study utilizes an adjuvant approach in which~     synthetic immunostimulatory DNA is conjugated to ragweed allergen in an attempt to modulate~     both the clinical and immunologic allergic response to ragweed exposure in ragweed-allergic~     patients with seasonal rhinitis.~   "
245075|NCT00346073|"~     GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug~     Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has~     recently issued provisional recommendations for universal adult Tdap vaccination. The current~     study will provide pivotal data in support of extending the age range for Boostrix vaccine to~     include adults 19-64 years of age.~   "
245076|NCT00346060|"~     The long-term goal is to show that retinal transplantation can help to prevent blindness and~     to restore eyesight in patients with dry age related macular degeneration.~   "
245077|NCT00346047|"~     The primary objective of this study is to evaluate the efficacy and safety of BTDS compared~     to placebo in subjects with moderate to severe low back pain.~   "
245078|NCT00346034|"~     The main purpose of this protocol is to evaluate the long-term safety of pregabalin in~     patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive~     open-label pregabalin therapy.~   "
245079|NCT00346021|"~     Purpose of the project is to develop a school-based intervention aimed at increasing hat use~     when children are outside at home and at school. The intervention is targeted to fourth grade~     children in Hillsborough County, Florida and is based on Theory of Reasoned Action and~     Planned Behavior. It is structured to accomplish the following goals: (a) increase sun~     protection knowledge of children in regards to hat use,(b) foster more positive attitudes in~     regard to wearing hats,(c) change the subjective norms of wearing hats (d) target persons~     that children perceive as controlling their behavior of wearing hats(parents,teachers) and~     increase the use of hats when children are outdoors at school(primary outcome) and when~     outdoors at times other than school(secondary outcome).~   "
245080|NCT00346008|"~     RATIONALE: Studying the genes expressed in samples of blood from patients with cancer and~     their family members may help doctors identify biomarkers related to cancer.~      PURPOSE: This clinical trial is studying genes to identify melanoma in patients in Iceland~     and their family members.~   "
245081|NCT00345982|"~     The purpose of the study is to determine whether addition of sertindole to clozapine~     treatment can improve psychosis or the metabolic side-effects of clozapine in patients with~     treatment-resistant schizophrenia.~   "
245082|NCT00345969|"~     The primary aim of this study is to determine, in hypogonadal older men with physical~     frailty, whether exercise training combined with testosterone replacement therapy can improve~     skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.~   "
245083|NCT00345956|"~     To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when~     co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study~     will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo~   "
245084|NCT00345943|"~     The aim of this project is to use both multimodal MRI and behavioral measures to investigate~     how changes in frontostriatal neural systems contribute to the development and persistence of~     Bulimia Nervosa (BN). Findings from this study will have wide-ranging importance for our~     understanding of the development and treatment of BN.~   "
245086|NCT00345917|"~     The long-term goal is to show that retinal transplantation can help to prevent blindness and~     to restore eyesight in patients with the inherited disease retinitis pigmentosa.~   "
245087|NCT00345904|"~     Vaccination is currently the most effective mean of controlling influenza and preventing its~     complications and mortality in persons at risk. Because of the variable nature of influenza~     viruses, the composition of influenza vaccines changes almost every year, to target the 3~     main circulating strains. Each year the influenza vaccine formulation may thus be different~     and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine~     formulated from the three annual circulating strains are similar to what was observed during~     the previous years.~      This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine~     containing the influenza strains recommended for the 2006-2007 season.~   "
245088|NCT00345891|"~     The purpose of this study is to evaluate the impact of delivering a coping-focused~     intervention as an adjunct to a self-help program to promote smoking cessation among~     relatives of lung cancer patients.~   "
245089|NCT00345878|"~     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.~     The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to~     cervical cancer in women. This study will evaluate the immunogenicity and safety of the~     HPV-16/18 L1 VLP AS04 vaccine.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
245090|NCT00345865|"~     RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer~     growth in different ways. Some block the ability of cancer cells to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them. Giving~     colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone~     marrow to the blood so they can be collected and stored for peripheral stem cell transplant.~     Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body~     irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells~     are then returned to the patient to replace the blood-forming cells that were destroyed by~     the chemotherapy and radiation therapy. More radiation therapy is given after transplant to~     kill any remaining cancer cells.~      PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant~     works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.~   "
245091|NCT00345852|"~     This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser~     photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.~   "
245092|NCT00345839|"~     The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or~     Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD)~     patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.~   "
245093|NCT00345826|"~     RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects of dasatinib in treating patients~     with chronic myelogenous leukemia or acute lymphoblastic leukemia.~   "
245094|NCT00345813|"~     RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients~     planning to undergo surgery.~      PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works~     compared to a placebo in treating patients undergoing surgery for localized prostate cancer.~   "
245095|NCT00345800|"~     To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus~     on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine~     changes.~   "
245096|NCT00345787|"~     The primary objective of this study is to evaluate the efficacy and safety of BTDS compared~     to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee.~   "
245097|NCT00345774|"~     This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in~     patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.~   "
245098|NCT00345761|"~     This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000~     mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2~     intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with~     advanced and/or metastatic colorectal cancer.~   "
245099|NCT00345748|"~     The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will~     demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis~     similar to the dose response efficacy previously observed in the International clinical~     trials.~   "
245100|NCT00345735|"~     Primary Objective:~      To demonstrate the efficacy of intranasal fentanyl in the treatment of breakthrough pain~     (BTP) in cancer patients.~      Secondary Objective:~      To explore the relationship between the response to the fentanyl dose and the stable~     background pain opioid dose.~   "
245101|NCT00345722|"~     The purpose of this study is to determine whether addition of strawberries to a dietary~     portfolio of cholesterol-lowering foods will improve compliance and so increase the~     effectiveness of the dietary portfolio in lowering cholesterol and improving cardiovascular~     risk factors.~   "
245102|NCT00345709|"~     Long-Term Objectives:~        -  To establish an ongoing national research registry of epidemiologic, clinical and~          pathologic data on low grade and low malignant potential (LMP) ovarian cancer patients~          in UTMDACC's Department of Gynecologic Oncology for research purposes.~        -  To create a bank of low grade and LMP ovarian cancer tumor blocks for study of the~          molecular and histopathologic differences among low grade ovarian cancer, ovarian LMP~          tumors and high grade ovarian cancer.~        -  To specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer~          patients.~        -  To identify potential precursors of low grade and LMP ovarian cancer.~        -  To assess treatment patterns to guide management of these diseases.~        -  To collect quality of life and health outcomes data on these patients.~        -  To achieve a fundamental understanding of low grade and LMP ovarian cancer that will~          inform prevention and screening efforts, motivate development of improved treatments and~          eventually result in a cure.~      The short-term objectives are:~        -  To detail procedures for potential registrant identification and recruitment.~        -  To create a demographic and health history questionnaire for potential registrants.~        -  To begin aggregating low grade and low malignant potential ovarian tumor blocks.~        -  To specify a timeline for the development of all other aspects of the Registry.~   "
245104|NCT00345683|"~     The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a~     control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00345579).~      No new recruitment will take place during this booster phase of the study. The Protocol~     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
245105|NCT00345670|"~     This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1,~     multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding~     of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory~     syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) at screening.~   "
245106|NCT00345657|"~     The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin~     in patients receiving standard care who are not at LDL goal per ATP III guidelines.~   "
245107|NCT00345644|"~     The primary objective of this study is to compare risedronate 35 mg and placebo with respect~     to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in~     osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative~     computed tomography (3D pQCT).~      The secondary objectives are to compare the percent change from Screening/Baseline between~     the 2 treatment groups for the following measurements:~        -  Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total~          proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;~        -  3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12,~          and 24 months; and~        -  Bone turnover markers (BTMs) of:~             -  fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen~               (CTX 1);~             -  serum aminoterminal propeptide of type 1 procollagen (PINP); and~             -  urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.~   "
245108|NCT00345631|"~     The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device~     is more effective than standard manual compression at sealing the puncture made in the~     femoral artery following a cardiac or peripheral diagnostic or interventional procedure while~     maintaining the same level of safety.~   "
245109|NCT00345618|"~     Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as~     effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic~     events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic~     deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.~   "
245110|NCT00345605|"~     Urea cycle disorders are inherited illnesses in which the body does not produce enough of the~     chemicals that remove ammonia, a byproduct of protein metabolism, from the blood stream.~     Elevated ammonia levels can lead to brain damage and death. Argininosuccinic aciduria (ASA)~     is a type of urea cycle disorder that is characterized specifically by high levels of~     argininosuccinic acid, a chemical involved in the urea cycle. People with ASA are at risk for~     serious liver damage, which may be due to the elevated levels of argininosuccinic acid.~     Sodium phenylbutyrate (Buphenyl-TM) is a drug that has been used to treat other types of urea~     cycle disorders. This study will evaluate whether Buphenyl-TM in conjunction with decreased~     arginine dose (in addition to a normal regimen of protein) will improve short-term liver~     function and decrease plasma citrulline and ASA levels in people with ASA.~   "
245111|NCT00345592|"~     Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and~     fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and~     to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared~     to an in-hospital approach for treatment of symptomatic AT/AF.~   "
245112|NCT00345579|"~     The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to~     a control group receiving licensed Hib conjugate vaccine, when each are co-administered with~     Pediarix® to healthy infants at 2, 4, and 6 months of age.~      This protocol posting deals with objectives & outcome measures of the primary phase of the~     study. The objectives & outcome measures of the Booster phase are presented in a separate~     protocol posting (NCT number = 00345683).~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007~   "
245113|NCT00345566|"~     The protein composition of nutrition may affect the rate of gastric emptying and gastric~     fysiology. This is espesially important in children with neurologic impariment, who commonly~     rely on tube feedings, have feeding problems, nausea, vomiting, gastroesophageal reflux and~     delayed gastric emptying. We aim to find out whether 4 different protein sources affect the~     rate of gastric emptying and electrofysiology in this group of children.~   "
245114|NCT00345553|"~     Little is known about the factors that cause biliary atresia nor the factors that influence~     disease progression. The purpose of this study is to collect the pertinent clinical~     information, genetic material and body fluid samples to enable investigators to address the~     following aims: To identify the gene or genes implicated in the etiology of BA; To identify~     polymorphisms that may be important in disease progression such as HLA polymorphisms; To~     characterize the natural history of the older, non-transplanted child with BA.~   "
245115|NCT00345540|"~     The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin~     in a cohort of women with platinum resistant cancer of ovarian origin.~   "
245116|NCT00345527|"~     Despite evidence of high rates of concurrent substance use and anger problems among problem~     gamblers, until recently there have been no empirically evaluated treatments for these~     co-morbid problems. A recent study (Korman, Collins, McMain, & Skinner, 2005) found that an~     emotion and behaviour regulation treatment (EBRT) was more effective than a gambling-only~     treatment-as-usual in engaging clients in treatment and in reducing gambling, anger, and~     substance use. This study is a replication of Korman et al's study and will compare an~     emotion and behaviour regulation treatment (EBRT) for problem gambling, anger and substance~     use to a manualized cognitive behavioural treatment (CBT) for problem gambling.~   "
245117|NCT00345514|"~     The purpose of this study is to examine the interaction between the personal attributes of~     clinicians and the organizations in which they work and the effect of interventions on their~     ability to implement an asthma disease management program. +~   "
245118|NCT00345501|"~     The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable~     morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is~     believed to play a pivotal role in the CMN mechanism. The aim of this study is to examine the~     efficacy of the prostacyclin analogue iloprost (dose 1ng/kg/min) in preventing CMN in~     high-risk patients undergoing a coronary procedure.~   "
245119|NCT00345488|"~     The study examines time spent in the emergency room on admission of patients with hip~     fracture in a cohort with a traditional setup compared with a prospective cohort with a fast~     track admission schedule including nurse initiation of treatmnet, standardized analgesia,~     fluid and oxygen therapy and standardized logistics for x-ray and admission procedures.~   "
245120|NCT00345475|"~     This is a prospective, observational, exposure-registration and follow-up study of women and~     their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception~     (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The~     UCB AED Pregnancy Registry is designed to monitor pregnancies exposed to Keppra® and Keppra~     XR® in order to determine if there is a potential increase in the risk of major birth defects~     compared to rates from women in the general US population.~      The objectives of the UCB AED Pregnancy Registry are:~        -  To prospectively collect data concerning 1) exposure to Keppra® and Keppra XR® during~          pregnancy, 2) potential confounding factors, 3) outcome of pregnancy, and 4) long-term~          pediatric outcome~        -  To review reported cases of possible birth defects~        -  To estimate the risk of birth defects occurring in live-born offspring of women exposed~          to Keppra® and Keppra XR® during pregnancy~      This study is being conducted in the United States (US). Enrollment in the Registry is~     voluntary. The UCB AED Pregnancy Registry is sponsored by UCB, Inc. and is managed by INC~     Research. The scientific conduct and analysis of the Registry is overseen by an Expert Panel~     consisting of external specialists in teratology/genetics, epidemiology, maternal and fetal~     medicine, and neurology (external member details available upon request).~   "
245121|NCT00345462|"~     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in~     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of~     these vaccines are required to be involved in ongoing clinical trials and to present the~     results to the competent authorities each year. The current study is a phase IIIa clinical~     trial with a commercially available virosomal vaccine (Invivac®) supplied in pre filled~     syringes. It is part of the ongoing clinical trial program for Invivac® and will be done to~     assess the immunogenicity and safety and tolerability of next season's trivalent influenza~     virosomal vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and~     subjects >= 61 years of age (elderly).~   "
245122|NCT00345449|"~     In 2006, the International Patient Decision Aids Collaboration (IPDAS) reached agreement on~     criteria for evaluation. Accordingly, the primary outcome is 'decision quality' 3 weeks after~     using the decision aid. Decision quality is defined as the extent to which a patient decision~     aid improves the match between the chosen option and the features that matter most to the~     informed patient. Measures include: a) patients' knowledge of essential facts [options,~     benefits, harms, and outcome probabilities]; and b. the congruence between the option chosen~     and patients' informed values regarding benefits and risks.~      In the past twenty years lung transplantation has become the most widely accepted option of~     treating cystic fibrosis patients with severe lung disease. Lung transplantation can be a~     good experience for many patients, improving their quality of life and their survival.~     However there are potential risks of lung transplantation including infection, organ~     rejection and early death. Cystic fibrosis patients are often faced with making a choice of~     whether to be referred for lung transplantation when they are very sick and there is the~     immediate need to survive. Our group has developed a tool called a decision aid which we hope~     will assist the patient and family in making this choice. The decision aid guides the patient~     through a series of steps where they weigh the benefits and risks of being referred for lung~     transplantation and the benefits and risks of receiving 'usual care' without the option of~     referral.~   "
245123|NCT00345436|"~     Insulin resistance, often accompanied by obesity, plays a major role in the development of~     type 2 diabetes. This phenomenon may be related with the fact that American adolescents are~     now becoming less physically active in early puberty, explaining the largely pubertal and~     post-pubertal onset of type 2 diabetes in adolescence. Although regular physical activity has~     been suggested to attenuate obesity and prevent type 2 diabetes in high-risk children and~     adolescents, the magnitude of exercise training-induced improvement in the risk factors for~     type 2 diabetes has been only recently studied in adults and studied very little in pediatric~     populations. It is clear that exercise, diet, and genetics all contribute to the development~     of type 2 diabetes in children. However, the few studies that have been done to dissect the~     relative contributions of these three risk factors have generally used only lipid profiles as~     the end point. There have been a number of recent advances in our understanding of the~     molecular basis of type 2 diabetes, particularly, with regards to insulin regulatory pathways~     modulated by exercise within muscle tissue.~   "
245124|NCT00345410|"~     Primary objective: to assess the effect of AVE1625 on weight loss over a period of 24 weeks~     in abdominally obese patients with atherogenic dyslipidemia. Secondary objectives: - To~     assess the dose effect relationship of AVE1625 on HDL-cholesterol and triglycerides plasma~     levels over a period of 24 weeks - To assess the efficacy of AVE1625 on secondary parameters~     such as waist circumference and other metabolic parameters over a period of 24 weeks - To~     assess the safety and tolerabillity of AVE1625 over a period of 24 weeks.~   "
245125|NCT00345397|"~     The investigators want to know if placing a tube through the skin and into the colon to flush~     out the colon is safe and effective in helping spinal cord Veterans with bowel management.~   "
245126|NCT00345384|"~     The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory~     stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients~     undergoing thoracic surgery after discharge from PACU or ICU.~   "
245127|NCT00345371|"~     The purpose of this study is to assess the efficacy and safety of topiramate as compared to~     placebo in reducing methamphetamine use in subjects with methamphetamine dependence.~   "
246015|NCT00333255|"~     The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension,~     0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating~     inflammation in the eye.~   "
245128|NCT00345358|"~     The purpose of this phase IIIb study is to determine whether children who have not received a~     3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of~     age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity,~     safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be~     evaluated for four different age groups with different schedules:~      < 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age~     group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose~     vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no~     booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib~     vaccine.~   "
245129|NCT00345345|"~     This study will examine the use of alemtuzumab (Campath ) in patients with T cell large~     granular lymphocytic leukemia (T-LGL). Patients with T-LGL often have reduced white blood~     cells, red blood cells and platelets, and increased numbers of abnormal cells called large~     granular lymphocytes (LGLs). Patients may have recurrent infections, anemia, or abnormal~     bleeding. Campath destroys specific parts of the abnormal LGLs, which interfere with the~     production of normal blood cells. This study will determine whether Campath can increase~     blood counts and reduce the number of abnormal LGLs in patients and will examine the side~     effects of the drug.~      Patients 18 to 85 years of age with T-LGL leukemia may be eligible for this study.~     Participants undergo the following procedures:~      Before starting Campath treatment~        -  Medical history and physical examination, blood tests, electrocardiogram (ECG).~        -  Echocardiogram (heart ultrasound) and 24-hour Holter monitoring (continuous ECG~          recording).~        -  Bone marrow biopsy: About a tablespoon of bone marrow is withdrawn through a needle~          inserted into the hipbone. The procedure is done using local anesthetic.~        -  Placement of central line, if needed: An intravenous line (tube) is placed into a major~          vein in the chest. It can stay in the body and be used for the entire treatment period.~          The line is used to give chemotherapy or other medications, including antibiotics and~          blood transfusions, and to collect blood samples. The line is usually placed under local~          anesthesia in the radiology department or the operating room.~        -  Apheresis: A catheter (plastic tube) is placed in a vein in each arm. Blood is drawn~          from one vein and run through a cell-separating machine, where the white blood cells are~          collected and saved. The remaining blood is transfused back to the patients through the~          vein in the other arm.~      During Campath treatment~        -  Campath therapy: After a small test dose, patients receive10 daily infusions of Campath~          , each of which lasts about 2 hours. The first few infusions are given at the NIH~          Clinical Center so that the patient can be monitored closely.~        -  Induction therapy: Aerosolized pentamadine, valacyclovir and other medicines are given~          to protect against or treat various infections that commonly affect patients with~          suppressed immune systems.~        -  Whole blood or platelet transfusions, if needed, and injections of growth factors, if~          needed.~        -  Blood tests and check of vital signs (temperature, pulse, blood pressure) every day~          during treatment. Echocardiogram and 24-hour Holter monitor after the last dose of~          Campath .~      Follow-up evaluations after Campath treatment ends~        -  Blood tests at home or at NIH (weekly for the first 3 months, then every other week~          until 6 months, then annually for 5 years~        -  Echocardiogram at NIH (at 3 months only)~        -  Bone marrow biopsy at NIH (at 6 and 12 months, then as clinically indicated)~        -  One repeat apheresis collection for laboratory studies.~   "
245130|NCT00345332|"~     The purpose of the study is to determine how effective Botox is in reducing the amount of~     urine leaked and which dose of Botox is more effective and safe in those who have urinary~     urge incontinence.~   "
245131|NCT00345319|"~     Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis~     regimen to healthy children and adults aged 10-60 years.~   "
245132|NCT00345306|"~     The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a~     hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a~     hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried~     out using estrogen stimulation followed by a concomitant progesterone treatment. Two~     progestative drugs are currently used in conventional IVF treatment, Utrogetan and~     Endometrin. Although Endometrin has been be efficiently used to support the luteal phase~     after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy~     for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of~     frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative~     substitution in an artificially prepared endometrium.~   "
245133|NCT00345293|"~     The purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell~     vaccine used as immunotherapy for prostate cancer. The vaccine is made with each~     participants' own immune cells obtained through blood donation. Dendritic cells are known to~     activate other immune cells such as T cells, that are able to mount an attack against cancer~     cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a~     course of 2 months.~   "
245134|NCT00345280|"~     Cystic fibrosis(CF) is an inherited disease affecting children, adolescents and young adults~     with dysfunction of secretory glands.It is caused by mutations in the protein-coding gene~     which function as the cystic fibrosis transmembrane regulator (CFTR), responsible for the~     secretion of chloride ions in epithelial cells, adenocytes, sweat gland cells, pancreatic~     ducts,alimentary and respiratory tracts and eye. Assessment of the relationship between the~     inflammatory processes and apoptosis in the eye in the course of cystic fibrosis will allow~     determination of immunological exponents which may facilitate diagnosis.~   "
245135|NCT00345267|"~     Integrated care pathways (ICP) coalesce medical and nursing work practices, unifying and~     directing care in line with current best practice and guidelines. We wish to examine the~     introduction of an ICP for children with wheeze/asthma admitted to our hospital. We will~     determine whether more rigid, but guided care results in faster recovery, quicker discharge~     with better education and fewer prescribing errors, but also determine whether staff feel~     alienated by the rigidity of practice, and parents perceive any benefit to the changes~     introduced.This will be a cluster randomised trial (random weeks) of standard or ICP care in~     180 patients admitted to Sick Kids with wheeze/asthma. Parents will be asked to complete a~     questionnaire on admission and contacted at 10-14 days post discharge and asked to recall~     education provided at discharge; no other patient or parent intervention will be required.It~     is expected to take 40 weeks to recruit 180 patients.~   "
245136|NCT00345254|"~     Umbilical cord often becomes encircled around portions of the fetus, usually the neck. The~     incidence ranges from 1 loop in 21% to 3 loops in 0.2%. In this study we wish to assessed the~     practice of severing the cord, which was encircled once around the neck of the fetus, after~     delivery of the anterior shoulder and prior to extraction of the body. The study and the~     control groups will include 30 women, each one. After diagnosis of cord around the neck~     during labor by ultrasound, the women will inter a randomization process. After delivery of~     the head, it will be cut intentionally in the study group and left intact in the control~     group. Neonatal outcome will be assessed.~   "
245137|NCT00345241|"~     To evaluate tear film stability of a market lubricant therapeutic eye drop versus saline when~     using Evaporometry and Interferometry in patients with a diagnosis of Keratoconjunctivitis~     Sicca (KCS). The purpose of this research is to evaluate evaporative parameters and tear film~     quality when using Systane lubricating eye drops versus saline in the eyes of dry eye~     patients at pre-instillation and at 30 and 60 minutes post instillation of drop(s).~   "
245138|NCT00345228|"~     1. To identify the underlying causes of macular haemorrhages in patients with high myopia~        2. In the eyes found to have macular haemorrhages secondary to choroidal~          neovascularisation, we hope to identify the risk factors for the development of~          choroidal neovascularisation in high myopia~        3. To study the functional outcome of these eyes as assessed by visual acuity~        4. To study the morphological outcome of these eyes by clinical assessment (and fundal~          photography) and fluorescein angiography~   "
245139|NCT00345215|"~     The aim of the study is to test the hypothesis that the function and/or regulation of~     aquaporin 2 and/or endothelial sodium channels in the principal cells of healthy humans is~     abnormal at high and low sodium intake~   "
245140|NCT00345202|"~     We wanted to test the shortterm effects of HMG-CoA reductase inhibition (atorvastatin) on~     renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.~   "
245141|NCT00345189|"~     This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and~     pharmacodynamics study.~   "
245142|NCT00345176|"~     Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant~     vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression~     to advanced age-related macular degeneration (AMD). Observational data suggest that increased~     dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty~     acids (docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA]), or both might further~     reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA,~     or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk~     of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta~     carotene and reducing zinc dose in the AREDS formulation.~   "
245143|NCT00345163|"~     This is a Phase II, open-label, multicenter, randomized, non comparative study consisting of~     two concurrent single-arms. Approximately 160 subjects will be randomized in a 1:1 ratio to~     Arm 1 (bevacizumab alone) or Arm 2 (bevacizumab + irinotecan).~   "
245144|NCT00345150|"~     The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in~     essential hypertension by investigating the effects of a non selective nitric oxide inhibitor~     on renal hemodynamics and sodium excretion in patients with essential hypertension. The~     results are compared with a group of healthy subjects.~   "
245145|NCT00345137|"~     The study tests the hypothesis that systemic and renal nitric oxide availability is changed~     in polycystic kidney disease and chronic glomerulonephritis.~   "
245146|NCT00345124|"~     The aim of the study is to test the following hypotheses:~        -  that the function and/or regulation of AQP2 and/or ENaC in the principal cells is~          abnormal in essential hypertension.~        -  if an abnormal function of the principal cells is present in essential hypertension,~          this will become more pronounced at high and low sodium intake.~   "
245147|NCT00345111|"~     The objective of the research on the Restore Intra Ocular Lens Implant (IOL) is to determine~     the clinical visual outcomes following bilateral implantation of the IOL compared to a~     control IOL and to demonstrate what percentage of the subjects obtain spectacle freedom.~   "
245148|NCT00345098|"~     The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of~     depressive symptoms in patients with major depressive disorder. Relapse will be assessed~     using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end~     of the initial 12-week open-label treatment period with SR58611A are randomized to continue~     SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional~     treatment. The secondary objective is to evaluate the safety of SR58611A in patients with~     MDD.~   "
245149|NCT00345085|"~     This project involves evaluation of post operative contrast sensitivity and wavefront~     aberration results among patients implanted with standard monofocal lenses (Acrysof~     SN60AT/SN60WF) and the new presbyopic correcting multifocal lens (Acrysof ReSTOR). Higher~     Order aberrations are visual phenomena such as glare and haloes. They are more prevalent~     after cataract surgery and can affect night driving.~   "
245150|NCT00345072|"~     The purpose of this study is to develop and test a web-based system intended to help women~     going through menopause make more informed choices regarding menopause treatments. The system~     will do this by giving women personalized feedback on the risks and benefits of these~     treatments.~   "
245151|NCT00345059|"~     The purpose of this study is to compare the overall survival of patients with advanced non~     small cell lung cancer treated with docetaxel as single therapy versus docetaxel in~     combination with either gemcitabine or vinorelbine or in combination with capecitabine.~   "
245152|NCT00345046|"~     Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.~   "
245153|NCT00345033|"~     This study will evaluate the effects of combination treatment with aripiprazole and clozapine~     on insulin resistance, blood fat levels, and weight gain in people diagnosed with~     schizophrenia.~   "
245154|NCT00345020|"~     The research objectives of this study are to determine if small incision Deep Lamellar~     Endothelial Keratoplasty (DLEK) is able to further reduce the degree of corneal astigmatism~     and shorten the time course of corneal topography stabilization compared to standard full~     thickness corneal transplant (PKP) surgery.~   "
245155|NCT00345007|"~     Assess recovery of macula function after successful scleral buckling surgery for~     rhegmatogenous retinal detachment by using the multifocal ERG in the postoperative period~     i.e. recovery of functional integrity 2. Assess the relationship between the neurosensory~     retina and the retinal pigment epithelium/choriocapillaris after scleral buckling i.e.~     recovery of structural integrity 3. Assess if there is a difference between macula function~     postoperatively, in eyes with retinal detachments involving the macula and those that do not.~   "
245156|NCT00344994|"~     The purpose of this study is to determine the equipotent dose of ropinirole and pramipexole~     for patients switched from pramipexole to ropinirole in patients with moderate to severe~     primary Restless Legs Syndrome (RLS). The rationale behind Switch is that patients with~     Restless Legs Syndrome can maintain stable efficacy and tolerability if correctly switched~     from one dopamine agonist to an equipotent dose of another.~   "
245157|NCT00344981|"~     Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea to~     maintain viral suppression below 50 copies/ml in volunteers who have achieved viral~     suppression on a standard HAART regimen.~   "
245161|NCT00344929|"~     Hypothesis A “multifaceted” intervention program aimed at increasing the responsiveness of~     care givers, the adequacy of care provided, and the efficacy of organisation of care, in~     presence of abnormal blood loss in the immediate post partum has more impact on the incidence~     of severe PPH and on the costs of care than the current methods of dissemination of clinical~     practice guidelines.~      Intervention Intervention group. The intervention includes three components: (1) outreach~     visits with local presentation of evidence-based clinical practice guidelines for management~     of PPH, and discussion of their applicability in the context of local organisation; (2)~     during these educational visits, reminders - check list, “PPH emergency case” containing~     appropriate materials – to be used in case of PPH, will be proposed; (3) finally, cases of~     severe PPH will be reviewed during peer review sessions organized in each participating unit,~     to help identifying weaknesses in care provided, and needs for improvement.~      Control group. The proposed guidelines for management of PPH will be disseminated through the~     participating perinatal networks; then each unit will be free to implement them at its own~     convenience.~      Randomisation procedure The trial follows a cluster randomised trial design. Randomisation of~     maternity units will be stratified by region, status (public versus private) and size (annual~     number of deliveries). The stratified design will guarantee the comparability of the two arms~     of the trial at baseline.~      Outcome measures The primary outcome is the incidence of severe PPH (number of severe PPH to~     number of deliveries). A severe PPH is defined as a PPH that was associated with one or more~     of the following: peripartum haemoglobin drop greater than 4g/dl, blood transfusion, arterial~     embolisation, surgical procedures such as hysterectomy or arterial ligation, transfer of the~     mother to intensive care unit, maternal death.~      Secondary outcomes include the cost of care and the cost/efficacy ratio, and the incidence of~     adverse effects of uterotonic drugs.~   "
245162|NCT00344916|"~     Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver~     cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is~     increased in liver cirrhosis.~   "
245163|NCT00344903|"~     The Dallas Heart Study (DHS-1) is a large, multi-ethnic, population-based epidemiological~     study designed to identify determinants of atherosclerotic heart disease (ASHD) in a~     representative United States (US) urban environment. This study completed enrollment in 2003.~      Our objective is to pinpoint factors contributing to progression:~        1. from health to ASHD risk;~        2. from ASHD risk to subclinical ASHD; and~        3. from subclinical to clinical ASHD.~      Identification of the critical factors in these transitions will enable targeted~     implementation of appropriate therapy to interdict before clinical ASHD develops.~   "
245164|NCT00344890|"~     The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated~     allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion~     of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or~     myelopathy.~      Patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. At 3 months after~     surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after~     surgery, the implanted bone dowels will be assessed for fusion. Patients will complete~     questionnaires and x-rays taken at each visit.~      The degree of subsidence and rate of fusion will be assessed based on the evaluation of the~     x-rays taken. The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the~     type of treatment that each patient has received.~   "
245165|NCT00344877|"~     OBJECTIVES:~      About 15% of patients suffering from focal epilepsy are refractory to available~     pharmacological treatments. Until now, the only hope for such patients has been the~     development of new pharmaceutical treatments or epilepsy surgery. In case of inoperability,~     different types of invasive brain stimulation such as vagus nerve stimulation or deep brain~     stimulation or non-invasive repetitive TMS have been evaluated to determine their~     anticonvulsive potential. For rTMS, weak and short lasting seizure reduction has been~     reported in different epilepsy syndromes.~      A new, non-invasive stimulation technique, transcranial direct current stimulation (tDCS),~     was useful to modulate cortical excitability in many cortical areas (M1, visual cortex,~     frontal cortex). Cathodal tDCS, with a current of 1 mA, induced long-term depression in~     animal models and reportedly decreased the excitability of both human and animal cerebral~     cortex. In epilepsy patients suffering from a malformation of cortical development, a single~     session of cathodal tDCS helped reduce seizures briefly. The purpose of this protocol is to~     study the effects of repeated applications of tDCS on the excitability of the seizure focus~     in patients with poorly controlled pharmacologically refractory temporal lobe epilepsy.~      STUDY POPULATION:~      We plan to study 56 patients between the ages of 18 and 80 suffering from temporal lobe~     epilepsy.~      DESIGN:~      Subjects will be allocated by blocked randomization to one of two groups (parallel design).~     Group A will receive cathodal tDCS and group B will receive Sham-tDCS on five consecutive~     days. Each subject will participate in 9 sessions (1 baseline visit, 5 intervention visits, 3~     follow-up visits). The effect of the intervention relative to the sham stimulation will be~     evaluated by comparing seizure frequency and neuropsychological tests during the 8 weeks~     before and after the intervention.~      OUTCOME MEASURES:~      Primary outcome measure will be the mean seizure frequency per 4 weeks in the tDCS group as~     compared to the Sham-tDCS group. To analyze the effect of the intervention (tDCS), seizures~     will be evaluated during a 2x4 week baseline period before tDCS and 2x4 weeks after the~     intervention. Using these data we will calculate the percentage change of seizures per 4~     weeks.~      Secondary outcome measures will be the scores of the neuropsychological testing (HVLT-R,~     BVMT-R, CTMT, COWAT) and number of epileptiform discharges in the EEG. Furthermore, th...~   "
245166|NCT00344864|"~     High order aberrations (HOA) are visual phenomena that decrease quality of vision. Examples~     of high order aberration are glare, halos, decreased contrast sensitivity and shape~     distortion. They are caused by slight imperfections or distortions in the corneal surface.~     HOA are currently measured using a variety of FDA approved devices. For this study, the~     LADARWave (Alcon) will be used to measure HOA. This device uses a harmless beam of light. It~     is FDA approved and non-invasive. Contact lens induced high order aberrations have never been~     measured and reported in the literature. This work may provide information to guide future~     contact lens design.~   "
245167|NCT00344851|"~     Current research has shown that the use of diabetes management practices aimed at reducing~     insulin resistance and hyperinsulinemia (such as weight reduction and the administration of~     oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism~     but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine~     called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal~     glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to~     extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on~     menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women~     with PCOS.~   "
245168|NCT00344838|"~     To compare the results of two commercially available customized laser ablation devices.~   "
245169|NCT00344825|"~     300 patients, starting a new pharmacological treatment for B-CLL, were enrolled by 36 Italian~     Centres for assessing the Quality of Life (QoL). A descriptive analysis of QoL and the~     correlation of the age, sex, stage of disease, Time from first B-CLL diagnosis, Number of~     previous B-CLL treatments, reason of starting of the new B-CLL treatment: therapeutic~     Regimen, type of Centre, B-CLL treatment lasting, response to B-CLL treatment.~   "
245170|NCT00344812|"~     A 17 week, double-blind, randomized, parallel group, four arm design outpatient study~     comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid~     dependence.~   "
245220|NCT00344136|"~     Heart disease and stroke disproportionately affect African Americans in the United States.~     These conditions are likely caused by both environmental and genetic factors. This study will~     attempt to identify specific genes of African and European ancestral origins that may~     influence the development of heart disease in African Americans.~   "
245171|NCT00344799|"~     Patients who are diagnosed with choroidal melanoma and undergo I-125 plaque or enucleation~     surgery consent to participate in the study. A tumor sample taken during surgery is studied~     in the lab for genetic features. These features and features of subjects' clinical course are~     recorded. Analysis of the data may identify genetic features that are indicative of~     prognostic factors including risk of metastasis.~   "
245172|NCT00344786|"~     CLL dosing escalating study; daily dosing schedule; PK/PD safety~   "
245173|NCT00344773|"~     The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of~     Gefitinib.~   "
245174|NCT00344760|"~     We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction~     phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower~     number of minority variant HIV-1 strains.~   "
245175|NCT00344747|"~     Obesity has become a pandemic, and it is today's principal neglected public health problem.~      Obesity has increased dramatically during the past two decades At adolescence, it is an~     aggravating issue, because obesity tends to persist in adulthood and the longer its duration,~     the higher the associated mortality and morbidity. Obesity imposes a heavy health and social~     burden, and it is widely recognized that treatment is costly. If obesity is not successfully~     addressed by late adolescence, the likelihood of weight loss in adulthood is as low as 5%.~     Therefore, prevention is crucial, and children and adolescents should be a priority target.~      Treatment of obesity is costly, time consuming, difficult and the results aren't always~     satisfying On most cases the patients receive dietary advice only (6-10 visits per year). And~     usually the patients end the treatment early due to lack of results.~      The best treatment of children and adolescent obesity is done in highly specialized settings,~     by a multidisciplinary team. Those programs have a limited number of locations (not always in~     proximity to the patients' residence), in addition, they are long term treatments and~     therefore are hard to complete successfully without additional support, Therefore only a~     limited number of patients can benefit from such programs.~      Due to the reasons mentioned above, many families tend not to start the process of treating~     their obese child, or turn to commercial weight loss programs, or put their children~     according to their beliefs and diets.~      Therefore ambulatory medicine is the ideal setting for the treatment of children and~     adolescent's obesity, it's also in proximity to the patients' residence, the medical team has~     a deep knowing of their patients and the possibility for long term maintenance and follow-up.~      We propose a trial of obesity treatment by behavior modification program, including parents~     as agents of change.~   "
245176|NCT00344734|"~     The study tests the hypothesis that nitric oxide availability is changed in congestive heart~     failure with regard to the regulation of renal hemodynamics, renal sodium excretion and~     release of vasoactive hormones. The study tests these hypotheses by comparing the effects of~     systemic nitric oxide inhibition with L-NMMA in congestive heart failure patients with~     healthy subjects on renal hemodynamics, blood pressure and plasma levels of vasoactive~     hormones.~   "
245177|NCT00344721|"~     To determine the effect of Essential Fatty Acids (EFA's) on Meibomian Gland lipids and~     aqueous tear production in patients with dry eyes.~   "
245178|NCT00344708|"~     To investigate the effect of using tissue cultured human amniotic epithelial cells to~     re-establish severely damaged ocular surfaces. Specifically, to determine the efficacy of~     transplanted tissue cultured amniotic epithelial cells on persistent corneal epithelial~     defect, a potential visual threaten ocular disorder.~   "
245179|NCT00344695|"~     The purpose of this study is to 1) evaluate the safety and efficacy of two doses of bupropion~     SR (150mg/day and 300mg/day) when compared to placebo, as an aid to smoking cessation in~     adolescents and 2) to examine which factors, such as medication adherence, nicotine~     dependence, and motivation to quit, affect treatment outcome.~   "
245180|NCT00344682|"~     This study is evaluating the efficacy and safety of the drug memantine (trade name NAMENDA)~     as an augmentation agent for the treatment of depression in people who are not fully~     responding to antidepressant medications.~   "
245181|NCT00344669|"~     The purpose of the study was to determine whether periodical mass deworming improves growth~     in children below six years of age.~   "
245182|NCT00344656|"~     This study will use functional magnetic resonance imaging to compare appetite-related brain~     activity in women with anorexia nervosa before and after receiving treatment for the~     disorder.~   "
245183|NCT00344643|"~     The purpose of this research is to compare the on-eye performance of 12 month daily wear~     versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable~     contact lenses by studying its effects on human eyes. Usual and customary care will be given~     in the form of eyeglasses and/or contact lenses.~   "
245184|NCT00344630|"~     To compare the relative efficacy and safety of the TAXUS Express2 stents and the Cypher~     stents among a broad, unselected patient population treated in a nationwide, multi-center~     clinical registry representative of 'real-world,' contemporary clinical practice. A secondary~     objective is to examine performance of the two stents in pre-specified subgroup populations~     and examine regional and national patterns in outcomes.~   "
245185|NCT00344617|"~     To assess the use of Avastin for the management of serosanguinous maculopathy~   "
245186|NCT00344604|"~     To evaluate the changes in quality of life parameters after LASIK surgery.~   "
245187|NCT00344591|"~     This study will evaluate the effectiveness of Structured Ecosystems Therapy (SET), a form of~     therapy that includes family and caregivers, at reducing HIV transmission risk behaviors and~     improving treatment adherence in HIV infected men newly released from prison.~   "
245188|NCT00344578|"~     To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW~     Medical Center at Dallas~   "
245189|NCT00344565|"~     The purpose of this study is to test whether a cognitive behavioral therapy (CBT) and a~     medication called modafinil, which is approved to treat sleep disorders, will help~     individuals who are abusing cocaine.~   "
245190|NCT00344552|"~     The purpose of this clinical research study is to learn if BMS-181339 can shrink or slow the~     growth of the cancer in patients with advanced or recurrent esophageal cancer. The safety of~     this treatment will also be studied.~   "
245191|NCT00344539|"~     The purpose of this study is to test an experimental malaria vaccine in about 75 healthy~     adults, 18-45 years of age. The study will also test an experimental adjuvant which is a~     material added to a vaccine to help the body make more defense cells. The body's immune~     response (response to foreign substances) and the safety of the vaccine will be tested. All~     subjects will receive 3 doses of vaccine on days 0, 28, and 56 and doses may increase during~     the study. Participation in the study is expected to be up to 323 days and includes 16~     visits. Study procedures include medical history, physical exams, urine and blood testing.~   "
245243|NCT00343811|"~     The purpose of this study is to evaluate the continued efficacy of modafinil treatment,~     compared to placebo treatment, in children and adolescents with~     attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment.~   "
245192|NCT00344526|"~     AL amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive~     deposition of amyloid fibrils derived from monoclonal Ig light chains, leading to multisystem~     organ failure and death. The prognosis for AL amyloidosis with conventional treatment remains~     poor, Autologous stem cell transplantation (ASCT) for AL amyloidosis produces high~     hematologic and organ responses. However, treatment-related mortality remains high and~     reported series are subject to selection bias.~   "
245193|NCT00344513|"~     This program is designed to improve medical care and education of hospitalized patients with~     heart failure and accelerate the initiation of evidence-based heart failure guideline~     recommended therapies by administering them before hospital discharge. A registry component~     focusing on admission to discharge and 60- to 90-day follow-up is designed to evaluate the~     demographic, pathophysiologic, clinical, treatment, and outcome characteristics of patients~     hospitalized with heart failure.~   "
245194|NCT00344500|"~     This program aims to help Veterans who take antipsychotic medications lose weight. The~     investigators use a program based on the American Diabetes Association's Diabetes Prevention~     Program, and the investigators have modified it to fit the lifestyles of people with mental~     illness. All participants are educated about nutrition and cutting down fat intake, how and~     when to exercise, and the causes of diabetes and how to prevent it. Participants must be~     Veterans who live within one hour of the West Los Angeles VA hospital.~   "
245195|NCT00344487|"~     To explore the hypothesis that the use of Lopinavir/ritonavir will be associated with~     improved CD4 immune reconstitution in volunteers who fail to demonstrate a significant CD4~     cell increase (while on their first antiretroviral treatment regimen) despite sustained viral~     suppression by a non-Lopinavir/ritonavir-containing regimen~   "
245196|NCT00344474|"~     Personality targeted cognitive behavioural interventions have been shown to be effective in~     reducing alcohol and drug misuse in adult substance abusers (Conrod et al., 2000) and~     adolescent drinkers (Conrod et al, in press). As these interventions target personality~     traits linked to risk for addictive and non-addictive mental disorders, the aim of this study~     is to examine the extent to which this approach can prevent and/or reduce alcohol and drug~     misuse as well as have an impact on the onset or severity of emotional and behavioural~     problems in young people.~   "
245197|NCT00344461|"~     Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and~     Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy~     will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction~     of FTC and Nevirapine. Truvada may be used.~   "
245198|NCT00344448|"~     This study will examine the effect of the drug Raptiva (efalizumab) in patients with~     Sjögren's syndrome (SS), an autoimmune disease affecting the glands producing saliva & tears.~     The cause of SS is not known, but inflammation plays an important role. Raptiva is approved~     by the Food and Drug Administration to treat psoriasis, an inflammatory skin disease.~     Patients 18 years of age & older with SS may be eligible for this study. Candidates are~     screened with a history & physical examination, chest x-ray, and oral & eye examinations.~      Participants are randomly assigned to receive either Raptiva or placebo (an inactive~     substance that looks like Raptiva) for the first 3 months of the study. For the next 3~     months, all participants receive Raptiva. Both Raptiva & placebo are injected under the skin~     once a week. Evaluation during treatment & for 2 months after treatment as follows:~      Full comprehensive evaluations (beginning of the study, at weeks 13 & 25 and 2 months after~     treatment ends):~        -  Physical examination & blood draw.~        -  Saliva collection done in two ways: 1) suctions cups connected to collection tubes are~          placed over the salivary gland ducts in the mouth and under the tongue; and 2) a~          sour-tasting liquid is applied to the top & sides of the tongue at 30-second intervals~          to stimulate saliva production.~        -  Eye exam for tear gland function.~        -  Questionnaires about mouth & eye dryness, energy level and overall well-being.~        -  Lip biopsy (screening & week 13 visits only). A few minor salivary glands are removed~          for examination under a microscope. The lower lip is numbed, a small cut is made on the~          inside of the lip, and several glands are removed. The cut is closed with a few stitches~          that are removed after 5 to 7 days.~        -  Magnetic resonance imaging of the parotid glands (salivary glands near the ear) at weeks~          1, 13 and 25. The patient lies on a stretcher that is moved into the scanner (a metal~          cylinder containing a strong magnetic field). The head is held in place during the scan.~          The study lasts about 90 minutes.~        -  Short evaluations at weeks 3, 5, 9, 15, 17, 21 and 1 month after treatment ends.~        -  Medical history & physical examination, blood draw, evaluation for changes in symptoms~          and side effects, review of current medications at weeks 3, 9, 15 and 21.~        -  Laboratory tests, evaluation for changes in symptoms and side effects, review of current~          medications, saliva collection without the sour liquid and short evaluation of tear~          production at weeks 5 and 17.~        -  Blood tests at week 29~   "
245199|NCT00344435|"~     This international study will identify genetic factors that may influence the development of~     inhibitory antibodies in patients with hemophilia A after treatment with factor VIII.~     Bleeding episodes in patients with inhibitors are often more difficult to treat. Previous~     research indicates that genetic factors play a role in the development of inhibitors. A~     better understanding of the influence of genes in this treatment complication may be helpful~     in predicting, treating or preventing inhibitors.~      People in families in which one or more members have severe factor VIII deficiency and one or~     more have a history of an inhibitor may be eligible for this study. Participants fill out a~     form with questions about the person's relationship to other family members taking part in~     the study. Those with hemophilia provide a brief medical history, including~     hemophilia-related information, inhibitor history and the presence of other conditions such~     as hepatitis C and HIV. All participants have a blood sample taken for laboratory and~     research tests.~   "
245200|NCT00344422|"~     The purpose of this study is to determine how well newly diagnosed multiple myeloma patients~     respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection)~     and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and~     Dexamethasone (VAD).~   "
245201|NCT00344409|"~     To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer~     patients receiving multi cycle platinum-containing chemotherapy~   "
245202|NCT00344383|"~     The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl~     estradiol, an oral contraceptive tablet, given in an extended regimen~   "
245203|NCT00344370|"~     This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind~     extension study for patients who participated in study NK-104-305.~   "
245204|NCT00344344|"~     A Pilot Study to Evaluate the Efficacy of Refined Methods to Mitigate Indoor Allergens in~     North Carolina and Boston, Massachusetts Homes~   "
245205|NCT00344331|"~     This study will evaluate clinical and laboratory tests that might be useful in determining if~     an investigational drug can slow the progression of Niemann-Pick Disease, Type C (NPC), a~     genetic disorder that results in progressive loss of nervous system function. The study will:~     1) look for a clinical or biochemical marker that can be used as a measure of response to~     treatment, and 2) define the rate of progression of biochemical marker abnormalities in a~     group of NPC patients who will later be invited to enroll in a treatment trial.~      Patients of any age with NPC may be eligible for this study. Participants undergo the~     following procedures every 6 months during 4- to 5-day admissions at the NIH Clinical Center.~        -  Medical evaluation, including medical history, physical exam, neurological exam,~          neuropsychometric evaluation, and blood and urine tests.~        -  Lumbar puncture (spinal tap): A sample of cerebrospinal fluid (CSF), the fluid that~          bathes the brain and spinal cord, is obtained for study. After administration of a local~          anesthetic, a small needle is inserted in the space between the bones in the lower back~          where the CSF circulates below the spinal cord. A small amount of fluid is collected~          through the needle.~        -  Eye exam and eye movement study: The pupils of the eye are dilated to examine the~          structures of the eyes. For the eye movement study a special contact lens is placed on~          the eye and the patient looks at a series of target light spots moving on a screen.~        -  Hearing tests.~        -  Electroretinography (in patients who can cooperate with the test) to measure the~          function of the retina. Before the test, the patient's pupils are dilated and an~          electrode (small silver disk) is taped to the forehead. The patient sits in a dark room~          for 30 minutes and then a special contact lens is placed on one eye after it has been~          numbed with drops. The contact lens senses small electrical signals generated by the~          retina when lights flash. During the ERG recording, the eye is stimulated with flashes~          of light projected inside a hollow sphere. After the test, a full eye exam is done and~          photographs of the retina are taken.~        -  Magnetic resonance imaging (MRI): This test uses a magnetic field and radio waves to~          produce images of the brain and obtain information about brain chemicals. The patient~          lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing~          earplugs to muffle loud knocking and thumping sounds that occur during the scanning~          process. Patients who cannot remain still in the scanner may be sedated for the test.~        -  Psychometric testing: Patients complete questionnaires.~        -  Photographs of the patient may be taken for use in teaching sessions or scientific~          presentations or publications, with the patient's consent. Patients may be recognizable,~          but are not identified by name.~        -  Pregnancy test in all female patients over 10 years of age at the beginning of each~          admission to the Clinical Center.~   "
245219|NCT00344149|"~     Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized~     thrombocytopenia.~      Splenectomy is the standard treatment for patients who fails the first-line treatment:~     corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. The aim of~     the study is to determine whether early treatment with Rituximab can result in durable~     remissions, and consequently, lead to the avoidance of splenectomy in a significant number of~     patients.~   "
245206|NCT00344318|"~     This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals'~     pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib~     and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of~     age.~      The study has 2 groups.~        -  One group of subjects will receive a 3-dose primary vaccination with the GSK~          Biologicals' pneumococcal conjugate vaccine (three different lots will be used and~          randomly allocated).~        -  The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.~      All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol~     posting deals with objectives & outcome measures of the primary study. The objectives &~     outcome measures of the Booster study are presented in a separate protocol posting (NCT~     number =00547248).~   "
245207|NCT00344305|"~     Open label, single arm, multicenter study of the shedding and safety of a single dose of~     trivalent, influenza virus vaccine live, intranasal in children 6 to < 60 months of age, with~     28-day shedding follow-up and 180-day safety follow-up.~   "
245208|NCT00344292|"~     Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls~     of arteries. New strategies are needed to prevent and treat atherosclerosis. The purpose of~     this study is to analyze the DNA of participants in two ongoing studies to identify genetic~     variations responsible for the development of atherosclerosis.~   "
245209|NCT00344279|"~     This study, sponsored by the National Institutes of Health and the Tuberculosis Research~     Centre and YRG-Care in Chennai, India, will examine how treatment of lymphatic filariasis in~     HIV-infected patients influences the amount of HIV virus in the blood and the progression of~     HIV infection to AIDS. Filarial infections are common in Chennai, and it is important to~     understand whether treatment of filariasis affects the course of HIV disease. The information~     gained from this study could be used to modify treatments for people both with HIV and~     filarial infections.~      Patients 18 years of age and older who are receiving treatment for HIV infection at the~     Government Hospital HIV clinic or YRG-Care may be eligible for this study. Two groups of~     patients will be recruited - patients with both HIV and filarial infections, and patients who~     have HIV infection alone, without filariasis. Candidates are screened with a medical history~     and review of medical records, physical examination, and blood and stool tests. Women have a~     urine pregnancy test.~      Within one month of screening, all participants receive a single dose of diethylcarbamazine~     and albendazole, a drug regimen commonly used to treat filarial infection. Patients are~     followed closely for the first 2 weeks after treatment to check for side effects. They are~     then seen at 1, 3, 6 and 12 months after the treatment dose for a physical examination and~     blood test.~   "
245210|NCT00344266|"~     This study will look at gene expression (whether particular sets of genes are activated~     [turned on] or deactivated [turned off]) in overweight people as compared to~     non-overweight individuals. It will also investigate the potential role of inflammatory and~     protective substances that are produced naturally by the body within fat tissue. Findings~     from the study may lead to the development of ways to predict who will respond best to diet~     therapy.~      Healthy individuals between 25 and 45 years of age may be eligible for this study. Overweight~     subjects must have a BMI of 25 to 40, and non-overweight control subjects a BMI of 19 to~     24.9. Candidates are screened with a medical history, physical examination, blood tests and~     electrocardiogram (EKG). They are instructed to record their dietary intake for a 3-day~     period and to collect their urine for a 24-hour interval.~      Participants have their food records reviewed a week after the screening visit. They are then~     scheduled for an overnight admission to the Clinical Center. Non-overweight subjects have one~     or two inpatient stays; overweight subjects have six inpatient stays plus frequent nutrition~     counseling sessions. During the 2-day hospital admissions, the following studies are~     performed:~        -  DEXA scan to determine the percentage of body fat tissue. The subject lies on a table~          for about 15 to 60 minutes while the body composition is measured with very low-dose~          x-rays.~        -  Single-slice CT scan to compare the amount of fat tissue under the skin with that in the~          abdomen. The subject lies on a table for about 5 to 10 minutes while the CT scanner~          measures body composition with very low-dose x-rays.~        -  Subcutaneous fat microdialysis to investigate how weight loss affects the activity of~          fat tissue. A small tube (catheter) is placed into the fat tissue under the skin of the~          abdomen after numbing the skin with a local anesthetic. Fluid samples are collected~          through the tube. The procedure lasts overnight. In five non-overweight controls, a~          small amount of a substance called leukotriene B4 is put into their fat tissue to help~          adjust the instruments used in the study.~        -  Air-displacement plethysmography to measure body composition. Subjects wear~          close-fitting clothing and enter a small capsule called a Bod-Pod. They breathe normally~          in the capsule while their body fat composition is studied.~        -  Blood tests. Blood samples are drawn to analyze thyroid hormones, lipids, glucose,~          electrolytes, clotting factors, kidney function, red cells and DNA.~        -  Euglycemic-hyperinsulinemic clamp to measure the effects of insulin in the body and to~          derive an index of insulin-sensitivity. Catheters are placed in a vein in an arm and in~          a vein in the hand on the other side of the body. Insulin and glucose are infused~          through the catheter in the arm, and blood samples are drawn from the catheter in the~          hand every 5 minutes to measure glucose levels. The test lasts about 2 hours.~        -  Subcutaneous fat biopsy to find out how weight loss affects fat tissue characteristics,~          gene regulation and the ability to store glucose. A small sample of fat tissue is~          obtained from the skin of the abdomen after numbing the area with an anesthetic.~        -  Nutrition counseling for overweight subjects. A nutritionist reviews the food record and~          designs a personalized diet for each participant.~        -  Weight loss intervention for overweight subjects. In addition to individual nutritional~          counseling, group sessions are provided every 2 weeks during the first 3 months of the~          study and then every month.~   "
245211|NCT00344253|"~     The purpose of this study is to investigate if interferon beta is superior to the standard~     treatment with Methotrexate for the treatment of intermediate uveitis and macular edema.~   "
245212|NCT00344240|"~     The purpose of the project is to better understand how exercise and education will help~     mobility and health in older adults with diabetes. The investigators are trying to learn what~     type of exercises and classes are needed to help older adults stay active. This knowledge~     will eventually prove useful in helping patients and doctors understand what is needed to~     keep older adults with Type 2 diabetes as healthy as possible.~   "
245213|NCT00344227|"~     The PrONTO Study was designed to evaluate the response of neovascular age-related macular~     degeneration (AMD) patients to intravitreal Lucentis using Optical Coherence Tomography (OCT)~     imaging. OCT was then used to determine the need for retreatment after 3 monthly injections~     of Lucentis. Patients would be followed for 2 years.~   "
245214|NCT00344214|"~     This study will evaluate the effectiveness of a sexual risk reduction intervention in~     reducing sexual risk behavior in HIV uninfected, heterosexual people who use methamphetamine.~   "
245215|NCT00344201|"~     Tisseel fibrin adhesive has been used extensively in many forms of surgery. Its use in eye~     surgery has been relatively recent. A few studies recently showed it was effective in~     securing conjunctival grafts in pterygium surgery, and in securing wounds after glaucoma and~     squint surgery.~      We sought to confirm its effectiveness in pterygium surgery, as well as prove its~     effectiveness in securing other material to the ocular surface such as amniotic membrane. Our~     hypothesis is that fibrin adhesive is effective in securing various types of material to the~     ocular surface for a sufficient length of time to allow adequate healing before it is~     absorbed and degraded.~   "
245216|NCT00344188|"~     This study will examine the natural history of Leishmanial infections and their treatments.~     It will provide an opportunity for NIAID staff to learn more about leishmaniasis and perhaps~     to improve diagnostic tests for these infections. Patients between 2 and 80 years of age with~     known or suspected leishmaniasis are eligible for this study.~      Participants will have routine blood tests and a biopsy to confirm leishmanial infection. The~     biopsy procedure will be determined by the type of infection local cutaneous leishmaniasis~     (LCL), mucocutaneous leishmaniasis (MCL) or visceral leishmaniasis (VL). CL will be confirmed~     with a punch biopsy, in which a cookie-cutter type razor is used to remove a small circular~     piece of skin tissue. MCL will be confirmed using a thin flexible tube inserted into the~     nose. This tube is used to examine the nose and upper airway and to remove a tissue sample,~     if an affected area is seen. VL will be confirmed with either a bone marrow or liver biopsy~     or a splenic aspirate. For these procedures, a small tissue sample is withdrawn through a~     needle placed in the hipbone, liver or spleen, respectively. Some patients may also have a~     skin test for leishmaniasis similar to tuberculin skin testing.~      Treatment and length of hospital stay are determined by the type of infection. CL may be~     treated with Pentostam, amphotericin, amphotericin B, itraconazole or ketoconazole; ML with~     amphotericin B, or encapsulated amphotericin; and VL with Pentostam or encapsulated~     amphotericin. Pentostam is infused daily for 18 to 28 doses, most as an outpatient. Blood is~     drawn 3 times a week for safety tests and an electrocardiogram is done 2 to 3 times a week to~     monitor heart rhythm. Amphotericin B is infused every day or every other day for about 30~     doses, all on an inpatient basis. Patients undergo hydration (infusion of a large amount of~     fluid) just before and immediately after each infusion to protect the kidneys. Blood is drawn~     every other day and urine samples are collected occasionally for routine urinalysis.~     Encapsulated amphotericin is infused every other day, on an outpatient basis. Blood is~     generally drawn every other day to every 2 days and urinalyses are done periodically.~     Itraconazole and ketoconazole are taken orally for at least 1 to 3 months, with blood drawn~     every 2 to 3 weeks.~      Patients may be asked to have photographs taken before, during and after treatment to~     document progress. They may also be asked to provide extra blood samples for research~     purposes, either through a vein in the arm or through apheresis, a method for collecting~     large numbers of cells. For apheresis, whole blood is collected through a needle in an arm~     vein and circulated through a machine that separates it into its components. The desired~     cells are then removed, and the rest of the blood is returned to the body, either through the~     same needle used to draw the blood or through a second needle in the other arm.~      Patients with cutaneous leishmaniasis will have a follow-up clinic visit 2 weeks to 3 months~     after treatment is completed. If there are no complications, their participation will end at~     that time. Patients with mucocutaneous leishmaniasis and visceral leishmaniasis will be~     followed every 3 to 6 months indefinitely for routine evaluations and re-treatment if the~     infection recurs.~   "
245217|NCT00344175|"~     This is a sixteen-week follow-on and 28 week single-blind extension study for patients who~     participated in study NK-104-304.~   "
245218|NCT00344162|"~     This study will examine a possible genetic basis for preeclampsia, a disorder of high blood~     pressure and protein in the urine during pregnancy. Preeclampsia is a major pregnancy~     complication affecting both mother and baby. Previous research has shown that preeclampsia~     tends to run in certain families. This study will determine which genes may be involved in~     preeclampsia.~      Women who have had preeclampsia (called the index woman) may be eligible for this study. They~     will be recruited through the Preeclampsia Foundation. In addition, the following relatives~     of the index woman may be enrolled:~        -  The child from the preeclampsic pregnancy~        -  The index woman's biological parents~        -  The index woman's siblings who have given birth or fathered a child and their family~          members~      The study will exclude any index women or family members who have had chronic hypertension,~     diabetes, polycystic ovary syndrome, or whose pregnancy that involved preeclampsia was a~     multiple fetus pregnancy or that was conceived through use of fertility technology.~      All women participants fill out a questionnaire to collect demographic data (e.g., age, race,~     marital status, etc.) and information on their medical and reproductive history, use of~     tobacco and medicines, and other factors that may be associated with preeclampsia syndrome.~     Women who have had preeclampsia or hypertension in pregnancy are asked to sign a medical~     record release form for study investigators to obtain a copy of the medical record for that~     pregnancy. All male and female participants provide a mouthwash rinse sample for extraction~     of DNA for gene studies. For babies too young to rinse with mouthwash, a soft brush is used~     to brush the inside of the mouth to collect cheek cells.~      Mouthwash samples are analyzed for genes that may be associated with preeclampsia.~   "
245221|NCT00344123|"~     Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral~     treatment regimen for resistant HIV-1 infection in adult patients. Since significant~     cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment,~     effective treatment strategies are critical to prevent long-term cardiovascular events.~     Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is~     unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal~     drug interaction study is needed before this combination can be recommended. This study will~     examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500~     mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered~     to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is~     co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant~     clinical interaction will occur.~   "
245222|NCT00344110|"~     Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential~     hypertension~   "
245223|NCT00344097|"~     This study seeks to determine whether soy protein supplements reduce the pain that often~     occurs following surgery for a lung tumor. Patients are randomized to receive either soy~     protein or milk protein prior to and following a thoracotomy for a lung tumor. We are~     especially interested in pain severity and pain medication use following surgery and will~     measure function and quality of life.~   "
245224|NCT00344084|"~     This study will examine why some people who become infected with the leishmaniasis parasite~     develop skin lesions and others do not. The parasite that causes leishmaniasis is transmitted~     by the bite of a sandfly. It can cause skin lesions that may persist for several months,~     spread to other parts of the body, and become infected with bacteria. Treated with medicine,~     leishmaniasis can be cured completely.~      People 1 year of age and older who live in the Mali villages of Kemena or Sougoula may be~     eligible for this study.~      Participants are injected with a small amount of inactive parasites into the skin of their~     arm. People who have a reaction to the test, and thus have been exposed to the parasite, are~     examined for skin lesions. Their lesions, if any, are evaluated and treated, and their~     participation in the study ends.~      Participants who do not react to the skin test are examined for skin lesions every month for~     5 months. Those who are 18 years of age or older and have mild leishmaniasis skin lesions may~     have a small amount of fluid injected into a lesion in order to remove parasites for~     laboratory analysis.~      Patients' lesions may be photographed to compare what they look like before and after~     treatment. Lesions are treated with an ointment containing an antibiotic and a disinfectant~     twice a day for 20 days. The lesions are examined 1 and 3 weeks after treatment is completed~     to see if the disease has been cured. A few months later, the skin test is repeated to~     determine whether the person has been exposed to parasites over the past year.~      A blood sample may be drawn from some participants, depending on whether they have a reaction~     to the second skin test and whether they have developed skin lesions. The sample is drawn~     only from patients 18-65 years of age.~      Some blood drawn for the study may be used for genetic tests.~   "
245225|NCT00344071|"~     One form of breast cancer, known as inflammatory breast cancer (IBC), is characterized by~     diffuse erythema (redness) and edema (peau d'orange) of the breast. This type of cancer is~     aggressive and poorly understood. It is rare in the United States (about 4 percent of cases),~     but more common in Egypt and Tunisia (up to 23 percent of cases). Conducting a case-control~     study of IBC is complicated by several factors, including the lack of standardized criteria~     for IBC. In addition, collecting pre-chemotherapy tissue and blood samples from IBC patients~     is difficult because treatment begins immediately after diagnosis.~      In this pilot study, the National Cancer Institute will collaborate with two major cancer~     centers and two hospitals (in Egypt and Tunisia) to determine the feasibility of a~     case-control study of IBC. The study will assess the number and characteristics of IBC cases,~     the feasibility of identifying cases at diagnosis, and the availability of control subjects;~     will collect frozen pre-treatment tumor tissue from five IBC cases to determine whether RNA~     isolation is possible; will obtain digital photographs of the breasts of IBC cases; and will~     demonstrate collaboration between the institutions and personnel involved in the study. The~     study will last for approximately one year.~      Participating hospitals will identify IBC cases. Consenting patients will undergo a breast~     examination in which the examining surgeon will complete an Initial Examination Form (IEF).~     Digital photographs of the breasts (but not face) will be taken and linked to the study ID~     number. Tissue examination results will be entered into the IEF. For five selected cases,~     additional pre-treatment tumor tissue will be collected and frozen.~      This pilot study will assess the availability of controls for a case-control study by~     investigating the number and type of admissions to the Ear, Nose, and Throat and~     Ophthalmology Departments at participating hospitals during 2000-2003, using computerized~     records.~   "
245226|NCT00344058|"~     Magnesium sulfate is used for seizure prophylaxis in pregnancies complicated by preeclampsia.~     There is debate as to how long to continue this therapy after delivery of the pregnancy.~     Different schemes have been offered to shorten the exposure to magnesium sulfate after~     delivery, with little data. We seek to investigate the effect of shortened magnesium sulfate~     therapy on the post-partum recovery phase of mild preeclampsia. Our hypothesis was that~     shortened therapy (12 hours versus the traditional 24 hours post-partum) has no effect on~     disease course, and will result in significantly shorter exposure to magnesium sulfate.~   "
245227|NCT00344045|"~     The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol~     versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour~     cumulative dose of the opioid tramadol in the treatment of postoperative pain following total~     hip arthroplasty.~   "
245228|NCT00344032|"~     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.~     Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can~     lead over time to cervical cancer in women . This study will evaluate the immune response~     induced by the HPV-16/18 L1/AS04 vaccine and the safety of the vaccine.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
245229|NCT00344019|"~     This study is designed as a prospective, randomized, placebo-controlled, double-blind~     analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to~     percutaneous coronary intervention [PCI] (at least 2 hours) in patients presenting with~     unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate~     occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on~     high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and~     patients with contraindications to statins will be excluded from the study. The primary~     endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a~     total of 150 patients (75 per group), the study is powered to detect a 30% difference in~     troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above~     the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and~     thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be~     started on statin therapy the day after the procedure, as deemed appropriate by their~     treating physicians.~   "
245591|NCT00338962|"~     The purpose of this study is to evaluate the efficacy of naltrexone in combination with an~     SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression.~      We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in~     alcohol consumption than that seen with treatment with SSRI alone, or with a combination of~     another class of antidepressant and naltrexone. We also hypothesize that SSRI will be~     effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.~   "
245230|NCT00344006|"~     Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium~     falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's~     Medicines and Healthcare products Regulatory Agency.~      CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a~     public-private partnership with the Medicines for Malaria Venture (MMV), World Health~     Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical~     Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a~     treatment for acute uncomplicated P. falciparum malaria.~      The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede~     chlorproguanil-dapsone for the same indication, but the addition of an artemisinin~     derivative, artesunate, should provide additional population benefits over~     chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce~     parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The~     addition of a second agent to the chlorproguanil-dapsone combination should also protect~     against the selection of resistant strains of P.falciparum.~      Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination~     Therapy actually available and is considered as the gold standard for the treatment of P.~     falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the~     combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key~     secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance~     Times (FCT) between CDA and artemether-lumefantrine.~   "
245231|NCT00343993|"~     with appropriate inspired oxygen concentrations, NPPV would prevent intubation and hence~     avert the poor outcome associated with the need of invasive ventilation in patients with~     ALI/ARDS.~   "
245232|NCT00343980|"~     This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to~     compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding~     rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety~     (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)~   "
245233|NCT00343954|"~     To evaluate PK and PD responses to L-citrulline given orally for four weeks to patients with~     sickle cell disease who are otherwise healthy.~   "
245234|NCT00343941|"~     This is a pilot study designed to determine a dose and schedule of Tucaresol that can be~     administered to HIV-1 infected subjects on HAART (highly active antiretroviral therapy) with~     viral suppression without occurrence of significant adverse events and that results in~     significant changes in cell mediated immunity.~   "
245235|NCT00343928|"~     This study will assess the behavioral effects of an amino acid mixture thought to influence~     serotonin function in individuals who have recovered from anorexia nervosa.~   "
245236|NCT00343915|"~     To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months~     after the first dose of the hepatitis B primary vaccination course.~      Subjects were aged 11 to 15 years at the time of the primary vaccination course.~      At the time of enrollment in the present long-term follow-up study subjects were aged 13 to~     18 years.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
245237|NCT00343902|"~     To determine the effect of hawthorn extract 450 mg bid vs. placebo, in addition to standard~     medical therapy in ambulatory patients with NYHA class II to IV chronic heart failure on~     submaximal exercise as measured by the 6-minute walk test~   "
245238|NCT00343889|"~     The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T~     vaccine in countries that follow the World Health Organization-Expanded Program of~     Immunization (WHO-EPI) schedule.~      The primary objective is:~        -  To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a~          lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to~          hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.~      The secondary objectives are:~        -  To describe in each group the immunogenicity parameters one month after the 3-dose~          primary series at 6, 10, and 14 weeks of age; and~        -  To evaluate the overall safety in terms of any adverse events in the first 28 days after~          each injection and any serious adverse events during the entire trial.~   "
245239|NCT00343876|"~     Inflammation is associated with worsening outcomes among individuals with CAD; C-reactive~     protein is a well-known marker of inflammation. Both healthy patients and those with a~     history of CAD who exhibit elevated CRP are at greater risk for cardiovascular events.~     Despite CRP's well- documented association with increased risk in the development and~     progression of CAD, the specific mechanism of elevated CRP in CAD is not known. One possible~     etiology includes a continuous prothrombotic process associated with CAD. Several studies~     demonstrate a link between platelet activation and inflammation. If thrombotic processes are~     involved in the mechanism of elevated CRP, antiplatelet therapy, including clopidogrel, could~     effectively reduce CRP. Preliminary studies have demonstrated a reduction of CRP with aspirin~     and a clear association between clopidogrel therapy and reduced CRP, however no randomized~     trials have been performed. We hypothesize that the proinflammatory effects of platelet~     activation may be inhibited with combined clopidogrel and aspirin therapy.~   "
245240|NCT00343863|"~     RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron hydrochloride, and~     palonosetron hydrochloride, may help lessen or prevent nausea and vomiting caused by~     chemotherapy.~      PURPOSE: This clinical trial studies how well giving dexamethasone together with ondansetron~     hydrochloride or palonosetron hydrochloride works in preventing nausea and vomiting in~     patients receiving doxorubicin hydrochloride and cyclophosphamide for early stage breast~     cancer~   "
245241|NCT00343850|"~     The purpose of this study is to determine if taking Asacol once a day is as effective as~     taking Asacol twice or three times a day in keeping ulcerative colitis inactive, and to~     determine which dosing regimen is easiest to follow. Once daily dosing of Asacol is~     experimental, and has not been approved by the FDA. Dosing as three times daily is FDA~     approved.~      This research is being done because the researchers want to learn what the best methods are~     for keeping ulcerative colitis inactive, and which way of taking Asacol is most helpful to~     subjects in continuing to take a medication to control their ulcerative colitis.~   "
245242|NCT00343824|"~     This study is to compare the treatment with two different silver-containing wound dressings:~     aquacel AG hydrofiber versus acticoat burn dressing.~   "
245244|NCT00343798|"~     This phase I multicenter feasibility trial is studying the safety and potential efficacy of~     infusing ex vivo expanded cord blood progenitors with one unmanipulated umbilical cord blood~     unit for transplantation following conditioning with fludarabine, cyclophosphamide and total~     body irradiation (TBI), and immunosuppression with cyclosporine and mycophenolate mofetil~     (MMF) for patients with hematologic malignancies. Chemotherapy, such as fludarabine and~     cyclophosphamide, and TBI given before an umbilical cord blood transplant stops the growth of~     leukemia cells and works to prevent the patient's immune system from rejecting the donor's~     stem cells. The healthy stem cells from the donor's umbilical cord blood help the patient's~     bone marrow make new red blood cells, white blood cells, and platelets. It may take several~     weeks for these new blood cells to grow. During that period of time, patients are at~     increased risk for bleeding and infection. Faster recovery of white blood cells may decrease~     the number and severity of infections. Studies have shown that counts are more likely to~     recover more quickly if increased numbers of cord blood cells are given with the transplant.~     We have developed a way of growing or expanding the number of cord blood cells in the lab~     so that there are more cells available for transplant. We are doing this study to find out~     whether or not giving these expanded cells along with one unexpanded cord blood unit is safe~     and if use of expanded cells can decrease the time it takes for white blood cells to recover~     after transplant. We will study the time it takes for blood counts to recover, which of the~     two cord blood units makes up the patient's new blood system, and how quickly immune system~     cells return~   "
245245|NCT00343785|"~     This clinical trial is studying how well giving cyclophosphamide together with anti-thymocyte~     globulin followed by methotrexate and cyclosporine works in preventing chronic graft-vs-host~     disease (GVHD) in patients with severe aplastic anemia undergoing donor bone marrow~     transplant. Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone~     marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune~     system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune system and help destroy any remaining abnormal cells. Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving anti-thymocyte globulin before and methotrexate and cyclosporine after~     transplant may stop this from happening~   "
245246|NCT00343759|"~     The purpose of this study is to see what kinds of breast tumors will respond to lapatinib.~     Lapatinib is an experimental medicine which may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
245247|NCT00343733|"~     The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl~     treatment compared to placebo treatment monthly over a 12-week treatment period in~     alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related~     chronic pain.~   "
245248|NCT00343720|"~     The purpose of this study is to establish the objective response rate (complete response +~     partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE~     alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who~     have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment~     group will be used as the control. The VELCADE single-agent treatment group will be used to~     determine if VELCADE administered weekly can demonstrate response rates.~   "
245249|NCT00343707|"~     This six-arm study is being conducted to measure the effect of a combination of paroxetine~     and vestipitant on the arousal induced by public speaking in Seasonal Effective Disorder~     (SAD) patients, using functional brain imaging readouts (i.e., WAT(Wave Analysis Technology)~     PET(Positron Emission Tomography)), after one or eight weeks of treatment. The effect of~     paroxetine alone after one or eight weeks of treatment will also be measured.~   "
245250|NCT00343681|"~     This study is designed to generate clinical data as outlined in the Note for Guidance on~     harmonization requirements for influenza vaccine marketing authorization by the European~     Medicines Agency.~      The objectives of the trial are:~        -  To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion~          influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the~          European Medicines Agency~        -  To describe the safety of the inactivated, split-virion influenza vaccine, Northern~          Hemisphere 2006-2007 formulation.~   "
245251|NCT00343668|"~     The primary goal of this phase II trial is to evaluate the response rate of combination~     chemotherapy with S-1 and Irinotecan in patients with advanced gastric cancer as a first-line~     therapy.~   "
245252|NCT00343655|"~     The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin~     80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect~     on evident necrotic lipid rich core of the plaque in patients.~   "
245253|NCT00343642|"~     Our objective is to determine whether a specific dietary intervention or a~     fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it~     is beneficial in the treatment of Crohn's Disease (CD.~   "
245254|NCT00343629|"~     RATIONALE: Giving healthy volunteers sulindac capsules or sulindac tablets may help doctors~     learn which form of the drug may be more effective in preventing cancer.~      PURPOSE: This randomized clinical trial is studying sulindac capsules to see how well they~     work compared with sulindac tablets in healthy volunteers.~   "
245255|NCT00343616|"~     RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and~     memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve~     quality of life and the ability to plan treatment for cancer.~      PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with~     breast cancer receiving hormone therapy on clinical trial IBCSG-1-98.~   "
245256|NCT00343603|"~     The purpose of this research study is to evaluate an investigational system that may allow~     doctors to show images of the different parts inside the eye that show greater detail than~     current equipment can produce.~   "
245257|NCT00343590|"~     The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy~     (WBV) on balance in a participant with multiple sclerosis (MS) related balance deficits as~     measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke~     Expanded Disability Status Scale (EDSS) and the Berg Balance Score.~   "
246701|NCT00323947|"~     This study will evaluate the safety and effectiveness of extended release methylphenidate~     (XR-MPH) in treating attention deficit hyperactivity disorder (ADHD) in children with both~     ADHD and epilepsy.~   "
245258|NCT00343577|"~     Fabry disease is a rare disorder that often has kidney involvement with increased urine~     protein excretion. Proteinuria is recognized as an important risk factor for progression of~     chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein~     excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry~     disease who already are receiving enzyme replacement therapy. A longitudinal, observational~     study is being undertaken to determine the utility of these agents in Fabry disease,~     realizing that these agents are primarily indicated for reducing systemic blood pressure, and~     most patients with Fabry disease have relatively low blood pressures at baseline.~   "
245259|NCT00343564|"~     This study was an early-phase trial arranged into two phases. The Phase I portion was a~     dose-escalation study designed to assess the safety, tolerability and to identify the maximum~     tolerated dose of SB-743921 in patients with Non-Hodgkin Lymphoma and Hodgkin Lymphoma. Phase~     II was intended to assess the activity, safety and tolerability of SB-743921 in patients with~     Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively. The Phase II portion of the~     study was not initiated.~   "
245260|NCT00343551|"~     The purpose of this study is to investigate the efficacy (blood pressure lowering effect) and~     safety of aliskiren given to hypertensive patients after a missed dose.~   "
245261|NCT00343525|"~     The purpose of this study is to determine the safety and tolerability of bavituximab when~     administered via an arm vein as multiple infusions and to examine how bavituximab behaves in~     the body and how it effects the amount of hepatitis C virus and immune modulators in~     individuals with chronic infection.~   "
245262|NCT00343512|"~     RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and~     pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant~     docetaxel therapy.~      PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve~     the clinical and pathologic complete response rate (pCR) and safety profile of single agent~     neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with~     single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel~     (either by repeat biopsy or definitive surgery).~   "
245263|NCT00343499|"~     24 week, single center, prospective, randomized, double-blind treatment study of valsartan~     (80 mg/bid, increased to 160 mg/bid) or placebo in addition to other general medical therapy~     in patients with persistent atrial fibrillation (AF) undergoing electrical cardioversion to~     restore normal sinus rhythm (SR).~   "
245264|NCT00343486|"~     This study will test the effectiveness and safety of two doses of solabegron against placebo~     in reducing the symptoms of overactive bladder.~   "
245265|NCT00343473|"~     The purpose of this research is to evaluate the optical coherence tomography (OCT), to image~     diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of~     diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage~     (eye diseases in the back of the eye) due to diabetes.~   "
245266|NCT00343460|"~     This randomized phase III trial is studying APF530 and dexamethasone to see how well they~     work compared with palonosetron and dexamethasone in preventing nausea and vomiting in~     patients receiving chemotherapy for cancer.~   "
245267|NCT00343447|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Vaccines may help the body build~     an effective immune response to kill cancer cells. Giving cyclophosphamide and rituximab~     together with vaccine therapy may kill more cancer cells.~      PURPOSE: This randomized phase II trial is studying cyclophosphamide and rituximab followed~     by two different schedules of vaccine therapy to compare how well they work in treating~     patients with chronic lymphocytic leukemia.~   "
245268|NCT00343434|"~     RATIONALE: A diet using a soy-based meal replacement may help survivors of breast cancer lose~     weight and improve their quality of life.~      PURPOSE: This clinical trial is studying how well a soy-based meal replacement works in~     helping women with stage I, stage II, or stage III breast cancer in complete remission lose~     weight.~   "
245269|NCT00343421|"~     The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants~     and toddlers when given at 2,3,4 and 12-18 months of age.~      Primary Objectives:~        -  To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both~          are co-administered with Prevenar®.~        -  To describe the post-dose 3 pertussis antibody responses.~      Secondary Objectives:~        -  To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both~          are co-administered with Prevenar®.~        -  To describe the safety after each vaccination following co-administration with~          Prevenar®.~   "
245270|NCT00343408|"~     RATIONALE: AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving AZD2171 together with standard combination chemotherapy may kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of AZD2171 when given~     together with standard combination chemotherapy in treating patients with advanced non-small~     cell lung cancer (NSCLC) or colorectal cancer.~   "
245284|NCT00343213|"~     P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and~     glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of~     p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse,~     whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be~     seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is~     able to predict the outcome of the lesion. The retrospective part of the study includes~     cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years.~     p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The~     prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV~     detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well~     as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be~     correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2~     pathologists without knowledge of clinical data.~   "
245271|NCT00343395|"~     Nearly half of all Americans will die from cardiovascular disease caused by the build up of~     atherosclerotic plaque within coronary arteries. Most deaths in these patients arise from the~     development of acute coronary syndromes (ACS) such as myocardial infarction, unstable angina,~     or sudden death. ACS is characterized by coronary plaque erosion or rupture, which is~     triggered by endothelial changes, including inflammation, and thrombosis. Diabetes, with~     insulin resistance as a major component, has been shown to engender adverse metabolic events~     within the endothelial cell [1], including impaired endothelial function, augmented~     vasoconstriction, increased inflammation and thrombosis. Activation of the transcription~     factors nuclear factor KB (NF-KB) and activator protein 1 (AP-1) induces inflammatory gene~     expression, with liberation of leukocyte-attracting chemokines, increased production of~     inflammatory cytokines, and augmented expression of cellular adhesion molecules. These~     metabolic processes may therefore play a significant role in the development of ACS.The~     hypothesis is that rosiglitazone and metformin, or the combination of both may provide~     positive anti-atherogenic effect, even among patients without diabetes. This pilot study~     proposes to evaluate the effect of placebo vs. combined rosiglitazone/metformin (Avandamet®)~     on surrogate blood markers of atherosclerosis activity among non-diabetic and pre-diabetic~     patients with known stable coronary syndromes. This will provide further evidence justifying~     a large definitive outcomes-based clinical trial.~   "
245272|NCT00343382|"~     RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients~     with breast cancer It is not yet known whether pilocarpine is more effective than a placebo~     in treating vaginal dryness in patients with breast cancer.~      PURPOSE: This randomized phase III trial is studying pilocarpine to see how well it works~     compared to a placebo in treating vaginal dryness in patients with breast cancer.~   "
245273|NCT00343369|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.~      PURPOSE: This randomized phase III trial is studying different combination chemotherapy~     regimens to compare how well they work in treating young patients with acute lymphoblastic~     leukemia.~   "
245274|NCT00343356|"~     Biochemotherapy (combined immunotherapeutic drugs and chemotherapeutic drugs) has shown~     virtue than that use chemical or biological drugs alone in the treatment of some malignant~     tumor. Here we investigated the efficacy of sequential intravesical therapy with EPI and BCG~     to EPI or BCG alone in patients with transitional cell carcinoma of bladder cancer after~     surgical management.~   "
245275|NCT00343343|"~     This trial is conducted in Europe. The aim of this investigation is to explore the safety of~     a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with~     diabetes.~   "
245276|NCT00343317|"~     Postpartum infections are among the leading causes of maternal mortality world-wide,~     particularly in under-resourced countries. Available data suggests that HIV infected women~     are at greater risk of postpartum complications than uninfected women. In South Africa,~     HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths~     (though indirectly), with puerperal sepsis among the 5 most common causes.~      This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648)~     women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36~     weeks of gestation during the antenatal period.~      Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and~     this morbidity can be reduced by use of prophylactic intrapartum antibiotics.~   "
245277|NCT00343304|"~     We will test whether robot driven, goal directed, trajectory corrected exercise enhances~     motor outcome in the upper limb of stroke patients better than matched motor activity on an~     upper body ergometer (monark).~   "
245278|NCT00343291|"~     The primary objective of this study will be to determine the progression free survival of~     patients with stage IIIb/IV non-small cell lung cancer (NSCLC) treated with dual agent~     monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with two~     different regimens of paclitaxel and carboplatin chemotherapy.~   "
245279|NCT00343278|"~     Valaciclovir (VACV), the L-valyl ester prodrug of aciclovir (ACV), is extensively converted~     to ACV and L-valine after oral administration. In subjects with normal renal function, ACV is~     predominantly eliminated unchanged in the urine, with a small proportion metabolized to~     9-carboxymethoxymethylguanine (CMMG). The metabolism of ACV to CMMG is thought to involve~     aldehyde dehydrogenase (ALDH). On the basis of a high proportion of the Japanese population~     having low-activity ALDH, it can be hypothesized that the conversion of ACV to CMMG is~     decreased, thereby leading, in patients with renal impairment, to higher plasma~     concentrations of ACV. This pilot study was conducted to investigate potential relationships~     between genetic polymorphisms of ALDH2, an isozyme of ALDH, and the plasma pharmacokinetics~     (PK) of VACV, ACV and CMMG in subjects with end-stage renal disease on hemodialysis.~   "
245280|NCT00343265|"~     The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm~     birth in women carrying 2 or more babies.~   "
245281|NCT00343252|"~     The purpose of the study is to determine if daily teriparatide reduces back pain more~     effectively than weekly risedronate in women with osteoporosis who have chronic back pain due~     to a spinal bone fracture.~   "
245282|NCT00343239|"~     Study objectives:~      To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the~     treatment of neoadjuvant gastric carcinoma.~   "
245283|NCT00343226|"~     The objectives of the study are:To compare the renal function of a quadruple~     immunosuppressive regimen (including basiliximab in combination with an optimized~     cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and~     corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard~     dose, mycophenolate mofetil and corticosteroids)~   "
245285|NCT00343200|"~     To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the~     treatment of men with ED and at least 1 prespecified risk factor who do not self identify as~     having ED.~   "
245286|NCT00343187|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in~     subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the~     face~   "
245287|NCT00343174|"~     Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can~     only be administered if treatment starts within 3 hours after onset of symptoms. This results~     in a still too small number of patients treated with rtPA ( < 15% in best clinical care~     institutions ). Ancrod is a differently acting biological drug which has been used for a long~     time but not for acute stroke treatment. STAT was the first RCT of medium size to show a~     significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed~     closely related to STAT but with a longer 6 hours window and specifically extended~     inclusion/exclusion criteria to avoid secondary complications possibly related to a longer~     time window.~   "
245288|NCT00343161|"~     The purpose of the study is to determine whether a maintenance treatment over 12 weeks with~     esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it~     compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy~     (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute~     treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.~   "
245289|NCT00343148|"~     Because AVI-4020 Injection was found to cross the blood-brain barrier, and because AVI-4126~     (RESTEN-NG) has potential medical benefit to people with a variety of diseases, including~     cancers, this study is being performed to find out if AVI-4126 also crosses the blood-brain~     barrier. If it does, then additional investigations could be performed, such as in people~     with certain types of cancer.~   "
245290|NCT00343135|"~     Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue~     infections~   "
245291|NCT00343122|"~     The purpose of the study is to evaluate agitated saline versus polygeline for detection of~     intrapulmonary vasodilatation in patients with cirrhosis.~   "
245292|NCT00343109|"~     This phase II trial is studying how well vaccine therapy works in treating patients receiving~     trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may~     help the body build an effective immune response to kill tumor cells~   "
245293|NCT00343096|"~     This study aims to address the hypothesis that Lorazepam (an anticonvulsant) is as effective~     when given via the intranasal or buccal route as the intravenous route in terminating~     convulsions in children.~   "
245294|NCT00343083|"~     The purpose of this study is to evaluate the response of the tumor to the treatment regimen~     that will be used in this study. This study will also test the safety of cetuximab (C225),~     given with chemotherapy and radiation therapy. We also want to see what effects (good and~     bad) cetuximab, chemotherapy, and radiation therapy have head & neck cancer.~      C225 has been designed to stop the growth of the tumor by blocking certain chemical pathways~     that lead to tumor cell growth. In prior studies with head & neck cancer patients, C225 has~     delayed tumor growth and provided relief of symptoms in some patients.~   "
245295|NCT00343070|"~     Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and~     after 8 weeks~   "
245296|NCT00343057|"~     To assess the impact of standardized written information on outcome in acute LBP.~   "
245297|NCT00343044|"~     The purpose of this study is to evaluate the clinical safety and toxicity of intravenous~     bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1,~     8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian~     tube and primary peritoneal cancer.~   "
245298|NCT00343031|"~     Experimental studies have documented the p'p-DDT, p'p-DDE (a metabolite of DDT) and other~     organochlorine (OC) compounds have estrogenic and/or antiandrogenic activities capable of~     altering normal endocrine functions. It has been postulated that exposure to these toxins~     during embriogenesis may cause urogenital malformations. However, this hypothesis has not yet~     been evaluated in humans populations with relatively high levels of exposure. The primary~     goal of this project is to study in utero exposure to DDE in relation to anogenital distance~     in humans. Anogenital distance is measured from a gender and species specific landmark on the~     genitalia, such as the junction of the penis and the scrotum in male humans, to the center of~     the anus. Altered anogenital distance is a sensitive manifestation of prenatal endocrine~     disruption in animal models; whether it is a sensitive endpoint in humans has not been~     studied. We will test the hypothesis that DDE, an androgen-receptor blocker, decreases~     anogenital distance in male humans who have been chronically but not occupationally exposed~     to DDT in Mexico. Study participants will be newborns and their mothers who live in the state~     of Chiapas, Mexico and who have been exposed to DDT through house spraying programs to~     control malaria in this area. Anogenital distance will be measured at birth and in utero~     exposure to DDE will be determined by measuring DDE in maternal blood.~      Demonstration that p'p-DDT or p'p-DDE may interfere with normal endocrine functions during~     embriogenesis will provide a model to increase our understanding of how other- more~     prevalent-environmental estrogens may act and will open new possibilities for research and~     potential control of etiologic factors related with this important public health problem.~   "
245299|NCT00343018|"~     This study, conducted by the NICHD in collaboration with Lancaster University in Lancaster,~     England, will evaluate the accuracy of information obtained from children using AN ADAPTED~     VERSION OF NICHD's interview protocol. The NICHD protocol was developed to help forensic~     interviewers OBTAIN INFORMATION FROM children who may be victims of or witnesses to a crime~     ABOUT THEIR EXPERIENCES. This study does not involve forensic interviews, but is DESIGNED TO~     OBTAIN INFORMATION FROM children ABOUT an event that takes place at their school. The study~     will examine how children report a brief interaction with an unfamiliar adult, how the memory~     of the event changes over time, and how the use of different interview techniques can help~     children give a fuller and more accurate accounts of past experiences.~      Children 5 and 6 years of age who attend local schools in the Lancaster, England, area may be~     eligible for this study. Participants will be told that they are going to have their pictures~     taken and will be escorted by a researcher to a room at the school with another researcher~     who is posing as a photographer. The photographer and the child will put on a costume, such~     as a pirate's outfit, over their street clothes, helping each other put on pieces of the~     costume. The photographer will take pictures of the child in the costume. They will each take~     off the costumes and the child will be told that he or she will receive the photographs at a~     later time. Another researcher posing as a photographer will come into the room, interrupting~     the event, and begin to argue with the first photographer about who had booked the equipment.~     They will resolve the argument and apologize to the child for the interruption.~      About 6 weeks after the event, the children will be interviewed using the ADAPTED VERSION OF~     NICHD interview protocol. Half will be interviewed first about the staged event (the photo~     session), followed by an interview about a fictitious event (e.g., a class visit to the fire~     station) that could plausibly have happened but did not. The other half of the children will~     be interviewed first about the fictitious event and then about the staged event. The children~     will be interviewed according to one of the following three procedures:~        -  The NICHD protocol preceded by a rapport-building phase that includes the rules of the~          interview and open-ended questions about the child and a recently experienced event~        -  The NICHD protocol preceded by a rapport-building phase that includes the rules of the~          interview and direct questions about the child and a recently experienced event, or~        -  The NICHD protocol preceded by the rules of the interview and open-ended questions about~          the child, but no opportunity to practice talking about a recently experienced event.~      After the interviewer has elicited as much information as is likely to be gained from verbal~     questions, he or she will present the child with a line drawing of a gender neutral person~     and ask the child to indicate where the child was touched by the photographer and where the~     child touched the photographer. Any child who provides a report of the fictitious event will~     be interviewed in the same way about the fictitious event. After 1 year, the children will be~     interviewed again in the same manner as the 6-week interview.~      The interviews will be audio- and videotaped to record the kind of information the children~     talk about and compare it to what actually happened in the event.~   "
245300|NCT00343005|"~     This study will determine the highest dose of an experimental vaccine called AMA1-C1 that can~     safely be given to adults exposed to malaria. Malaria affects about 300 million to 500~     million people worldwide each year, causing from 2 million to 3 million deaths, mostly among~     children under 5 years of age in sub-Saharan Africa. It is the leading cause of death and~     illness among the general population of Mali in West Africa. Increasing drug resistance to~     the malaria parasite, as well as widespread resistance of mosquitoes (the insects that~     transmit the parasite) to pesticides are reducing the ability to control malaria through~     these strategies. A vaccine that could reduce illness and death from malaria would be a~     valuable new resource in the fight against this disease. AMA1-C1 is an experimental vaccine~     developed by the NIAID. Early tests of AMA1-C1 in 30 healthy people in the United States~     found no serious harmful side effects of the vaccine. This study will look at the effect of~     AMA1-C1 in people in Mali who have been exposed to malaria.~      Residents of Don gu bougou, Mali, who are between 18 and 45 years of age and are in general~     good health may be eligible for this study. Candidates are screened with a medical history~     and physical examination, blood and urine tests, and urine pregnancy test for women.~      Participants are randomly assigned to receive three injections (shots) of either the~     experimental malaria vaccine or a hepatitis B vaccine that is approved and used in Mali. All~     shots are given in an upper arm muscle. After the first shot, the second is given 1 month~     later, and the third is given 12 months after the first. Subjects receiving AMA1-C1 will get~     one of three different doses - low, medium, or high - to find the dose that is safest and~     gives the best antibody response to the vaccine. After each shot, participants remain in the~     clinic for 30 minutes for observation. They return to the clinic 1, 2, 3, 7, and 14 days~     after each shot for a physical examination and to check for side effects. Blood samples are~     drawn before each shot and at selected return clinic visits to check for side effects and to~     measure the effect of the vaccine.~      During the rainy seasons after the second and third vaccinations, subjects come to the clinic~     once a month for an examination and a blood test. During the dry season, subjects come to the~     clinic 3 months before the last shot is given for an examination and blood test. Additional~     blood tests may be done on participants who develop malaria.~      If found to be safe in adults, further studies with this vaccine will be done in children~     exposed to malaria, as it is children who bear the brunt of this disease.~   "
245301|NCT00342992|"~     The Alpha-Tocopherol Beta-Carotene Cancer Prevention (ATBC) Study was a large randomized,~     double-blind, placebo-controlled, 2x2 factorial design, primary prevention trial testing the~     effects of alpha-tocopherol and beta-carotene supplements on cancer incidence and mortality~     conducted in Finland as a collaboration between the Public Health Institute (KTL) of Finland~     and the U.S. National Cancer Institute. The intervention period ended in 1993, and the~     research project was continued as a passive follow-up of participants during the~     post-intervention period to monitor potential intervention effects on cancers, as well as~     other morbidity and mortality endpoints. The cohort follow-up serves as a basis for cancer~     epidemiological research of a wide range of cancer risk factors, biomarkers, and genetic~     predisposition based on data and biologic samples collected during the study. This research~     is aimed at testing hypotheses relevant to cancer prevention, etiology, and early detection,~     and the study material provide an invaluable resource for the study of dietary, biochemical~     and molecular hypotheses. The analyses are made particularly informative in that nearly 20~     years of follow-up are available for study.~   "
245302|NCT00342966|"~     The chemopreventive efficacy of Se was tested in a 10-year human intervention trial; total~     and lung cancer mortality, total cancer incidence, colorectal cancer and prostate cancer~     incidence decreased. This study is designed to compare, via stable isotope tracer studies the~     kinetics of inorganic and organic Se before and following two years of oral supplementation~     with L-selenomethionine, to measure forms of Se in the plasma (extracellular Se-dependent~     glutathione peroxidase [GSHPx], selenoprotein-P [SeP], albumin-bound Se [AlbSe] and~     nonprotein-bound low molecular weight [LMWSe] fractions), and to determine the effects of~     supplementation on the ecology of the hindgut microflora. The forms of Se were chosen to~     resemble the metabolism of the principal forms of Se in mixed American diets. Sodium~     selenite, an inorganic form, is metabolized by reduction to selenide which is then either~     used in the co-translational synthesis of SeCys in specific Se-containing proteins (e.g.,~     glutathione peroxidases, diodinases, selenoproteins P and W), or is converted to methylated~     excretion products; in this sense it resembles the food form selenocysteine (SeCys) which is~     metabolized to the selenide level. Selenomethionine (SeMet), an organic form, is a major form~     of Se in many foods, particularly those of plan origin. In addition to being metabolized to~     selenide, SeMet also enters the metabolic protein pool by competing with the~     sulfur-containing amino acid, methionine. A study is proposed to assess the impact of~     selenium (Se) supplementation on its metabolism in humans.~      A pilot study will be conducted to test recruitment strategies and sample collection,~     preparation and analysis and to assess the detectability of two stable isotopes given~     together. Four subjects will receive two 300 ug oral doses consisting of 150 ug of the stable~     isotope 76Se as selenite and 150 ug of the stable isotope 74Se as selenomethionine on study~     days one and twelve. Subjects will be followed for six weeks.~      In the first pharmacokinetics tracer study (PK1), twenty-eight subjects will receive the same~     two labeled stable isotope doses, and will be followed for 4 months. In addition, two~     subjects who have been self-supplementing with 200 ug of Se as selenized yeast for two years~     will take part in PK1 to assess the sensitivity over time of the tracer assay in supplemented~     subjects. PK1 will be followed by a 2-yr supplementation period, in which all 28 subjects~     will receive daily doses of 200 ug of L0SeMet; subjects = metabolism is expected to approach~     a new steady state reflective of long-term supplementation. A second 4-month pharmacokinetic~     tracer study (PK2) will then be conducted while subjects remain on Se-supplementation with an~     extension of six monthly blood samples. Extensive sampling of plasma, urine, and feces during~     PK1 and PK2 will permit both the refinement of existing baseline models for selenite and~     selenomethionine metabolism in humans and the investigation of changes in metabolism arising~     from Se-supplementation. The study is designed to detect a difference of 0.75 standard~     deviation units in pre-versus post-supplementation rate parameters, assuming a two-sided test~     with an alpha level of 0.05 and a power of 0.80.~      The non-absorbed portion of Se may favor portions of the normal colonic bacterial microflora~     that produce certain short-chain fatty acids that colon cells use for energy. To test this~     hypothesis, fecal specimens will be analyzed for short-chain fatty acids over the course of~     Se-supplementation. In addition, the sampling of buccal cell-Se and of toenail-Se on a~     quarterly basis over the course of the study and assay of thyroid hormone levels during the~     first year of the study will permit the investigation of possible changes in levels resulting~     from supplementation.~   "
245303|NCT00342953|"~     This study will examine long-term health effects of cosmetic breast augmentation~     (enlargement) with silicone gel breast implants. There has been concern for some time about~     the possible effects of breast implants on the immune system particularly regarding the~     development of certain connective tissue disorders and on the possibility that implants may~     interfere with the ability to detect breast cancers. More recently, concerns have been raised~     regarding the possible cancer-causing effect of the implants themselves. These concerns were~     heightened by reports that the polyurethane foam coating that envelops the silicone gel in~     some implants may dissolve and produce a chemical called 2,4,-diamino toluene (TDA), which~     has been linked to an increased risk of breast and other cancers in rats and mice.~      To address this issue, this study will gather information from the medical records and a~     questionnaire survey of approximately 12,000 breast implant patients. The questionnaire will~     request information on perceived complications of the implants; history of breast~     examinations and mammograms; frequency of breast self examination; development of diseases~     (particularly cancers and connective tissue disorders) developed subsequent to the~     augmentation surgery; potential risk factors for these diseases, such as age at menarche~     (onset of menstruation), age at first birth, age and type of menopause (natural or due to~     surgery); history of breast biopsies; immune system and connective tissue disorders;~     cigarette smoking; alcohol consumption; family medical history, and so forth. To evaluate the~     results, the information will be compared with the same data on 4,000 women who underwent~     other plastic surgery procedures, such as rhinoplasty, facelift, liposuction, dermabrasion,~     eyelifts, and others, from the same practices as the breast augmentation patients.~      Participants will be recruited for the study from several large reconstructive and plastic~     surgery practices. Among the breast implant patients, women who have had bilateral breast~     implants for cosmetic purposes only, and not as breast reconstruction after breast cancer~     surgery, will be eligible. Women with a history of breast cancer may not participate.~   "
245304|NCT00342940|"~     The present study aims to evaluate safety and immunogenicity of one dose of a commercially~     available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in~     non-elderly adult and elderly subjects.~   "
245305|NCT00342927|"~     The Family Investigation of Nephropathy and Diabetes (FIND) is a multicenter study designed~     to identify genetic determinants of diabetic kidney disease. FIND will be conducted in eleven~     centers and in many ethnic groups throughout the United States. Two different strategies will~     be used to localize genes predisposing to kidney disease: a family-based genetic linkage~     study and a case-control study that utilizes admixture linkage disequilibrium. The center~     based at the Phoenix office of the National Institute of Diabetes and Digestive and Kidney~     Diseases (NIDDK-Phoenix) will conduct family-based linkage studies among American Indian~     populations in the southwestern United States.~      Participants (index cases) with diabetes and kidney disease will initially be recruited, and~     their parents and siblings will also be invited to participate. Genetic material from these~     participants will be used to genotype markers throughout the genome. Linkage analysis will be~     conducted to identify particular chromosomal regions containing genes that influence~     susceptibility to diabetic kidney disease. Linkage analyses will also be used to identify~     genes influencing traits related to diabetic kidney disease, such as serum creatinine,~     urinary protein excretion, plasma glucose levels, blood pressure and blood lipid levels.~     Regions that show evidence for linkage will then be examined in more detail, with both~     genetic linkage and association studies, to attempt to identify the specific genes that~     influence diabetic kidney disease, or related traits.~      The identification of genes that influence susceptibility to diabetic kidney disease will~     lead to a better understanding of how kidney disease develops. In the long run, this may lead~     to improved treatment and prevention of diabetic kidney disease.~   "
245312|NCT00342810|"~     Since 1948, the Framingham Study has examined a group of men and women every two years for~     the primary purpose of studying the incidence and prevalence of cardiovascular disease and~     its risk factors. In 1971 the Framingham Study began a study of the offspring of the original~     group, including data collection on blood pressure, cigarette smoking, weight, and other~     factors that are of interest to studies of eye disease. Researchers gave eye exams to some of~     the original group and to the offspring group. Data from these eye exams have been used to~     examine risk factors for cataracts, diabetic retinopathy, myopia, and glaucoma.~      The purpose of this study is to use the previously collected data for continued research on~     eye-related disorders. No new eye examinations will be conducted.~   "
246702|NCT00323934|"~     In this study, MGCD0103, a new anticancer drug under investigation, is given three times~     weekly to patients with advanced solid tumors or Non-Hodgkin's Lymphoma.~   "
245306|NCT00342888|"~     Childhood leukemia is the most common type of childhood cancer and its etiology is largely~     unknown. Most case-control studies of childhood leukemia have reported elevated risks among~     children whose parents were occupationally exposed to pesticides or who used pesticides in~     the home or garden. Investigators at the University of California at Berkeley (UCB) conducted~     a case-control study of childhood leukemia in 35 counties in the San Francisco Bay area and~     the agricultural Central Valley of California. A major focus of the UCB study is to evaluate~     whether household or occupational exposure to pesticides increases the risk of childhood~     leukemia. Our collaboration provided additional funding to collect carpet dust samples for~     the measurement of pesticides and other chemicals. For 470 participants, we attempted to~     collect carpet dust using a special high volume small surface sampler (HVS3) vacuum and by~     taking dust from participants vacuum cleaner. As of July 2006, dust samples will be collected~     only from participant's vacuum cleaner. Samples were collected at a home visit approximately~     3-6 months after the first in-person interview. We will also provide support for mapping of~     the crops (i.e., determining crop field boundaries and crop species) within 1200 meters (3/4~     mile) of residences so that the residential proximity to agricultural fields treated with~     pesticides can be determined. We will conduct the epidemiologic analysis of pesticide and~     other chemical levels in carpet dust and risk of childhood leukemia. We will also evaluate~     whether residential proximity to agricultural pesticide use is associated with risk of~     leukemia. Further, we will conduct an Exposure Pilot Study that will include a subset of the~     study population. Two components of the Pilot Study will evaluate how well a used vacuum bag~     and a window sill wipe predict pesticide and other chemical concentrations in carpet dust~     samples collected with the more complicated HVS3 vacuum method. The third component will~     compare pesticides detected in carpet dust with pesticides predicted by geographic proximity~     to agriculture.~   "
245307|NCT00342875|"~     Data from the new cancer atlas covering the period 1974 1994 indicates that deaths from~     bladder cancer among white men and women are elevated in the northeastern United States,~     particularly the northern parts of New England. The reason for these elevated rates of~     incidence of and deaths from bladder cancer is unknown. Only part of the excess risk can be~     explained by exposure to the textile and leather industries.~      The purpose of this study is to determine the factors that contribute to the high rates of~     incidence of and death from bladder cancer in northern New England. The main objectives are~     to:~        -  estimate the risk of developing bladder cancer associated with inorganic arsenic in~          drinking water, other water contaminants, tobacco use, occupational exposures,~          residential proximity to industrial sites, dietary factors, ethnicity, and use of~          wood-burning stoves.~        -  estimate the extent to which water containing inorganic arsenic explains the increased~          rates of bladder cancer.~        -  estimate the extent to which exposure to other risk factors explains the increased~          rates.~        -  evaluate risk of bladder cancer according to genetic factors.~        -  examine interactions of these factors with tobacco use, occupational exposure, and~          environmental exposure to arsenic and other compounds.~      All people ages 30 79 with confirmed cases of bladder cancer will be eligible for the study.~     Twelve hundred people with bladder cancer and twelve hundred individuals with no previous~     bladder cancer will be included.~      After potential participants are recruited and agreement is obtained over the telephone, they~     will complete a calendar and collect toenail clippings prior to the home interview. During~     the home visit, an investigator will administer a computer-assisted personal interview,~     collect drinking water samples and the clippings, and obtain a global positioning satellite~     reading. Other biological samples, such as saliva samples, urine, and blood, may be~     requested.~      Private wells at any previous homes of participants will also be sampled. The location of~     previous homes will be determined and the current homeowner will be asked to allow sampling~     of the well.~      The associations between bladder cancer and environmental exposures will be examined and the~     extent to which exposures to such risk factors explain the elevated mortality and incidence~     in northern New England will be estimated.~   "
245308|NCT00342862|"~     This is an observational, exposure-registration and follow-up study, to be conducted in the~     United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant~     subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the~     risk of major birth defects.~      The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development~     and will be managed by INC Research. The Registry will be monitored by an independent~     Advisory Committee of external experts in relevant specialties of teratology, epidemiology,~     maternal and fetal medicine, and infectious disease medicine (external member details~     available upon request).~   "
245309|NCT00342849|"~     The Treatment of Lead-Exposed Children (TLC) clinical trial compared the effect of lead~     chelation with succimer to placebo therapy. TLC was a randomized, double-blind,~     placebo-controlled clinical trial with sites in Cincinnati and Columbus, Ohio, Philadelphia,~     Pennsylvania, Baltimore, Maryland and Newark, New Jersey. The study was designed to test~     outcomes in IQ, neuropsychological function, behavior, physical growth and blood pressure~     three years after initiation of treatment. Enrollment was conducted between 1994 and 1997,~     with completion of the initial three-year follow-up in 2000.~   "
245310|NCT00342836|"~     This study will examine tissue specimens from patients participating in a trial of high-dose~     myo-inositol to prevent lung cancer. The trial, conducted at the British Columbia Cancer~     Agency-Vancouver Cancer Center (BCCA-VCC), includes people who have pre-cancerous changes in~     the air passages of their lungs.~      The BCCA-VCC trial was designed to determine side effects of taking large amounts of the food~     supplement myo-inositol for longer than a month and if the supplement can help smokers stop~     smoking.~      The current study will look at the levels of a substance called Akt in tissue samples~     obtained from air passages of subjects in the BCCA-VCC trial. Akt is activated by tobacco~     components and can be found in lung tumor specimens and pre-cancerous lesions. Myo-inositol~     may affect Akt levels and help prevent progression of pre-cancerous lesions to cancer.~      People participating in the BCCA-VCC phase 1 myo-inositol trial are eligible for this study.~     Tissue samples obtained from air passages of these patients during their participation in~     that study will be sent to the National Cancer Institute for analysis of Akt levels.~   "
245311|NCT00342823|"~     Visceral leishmaniasis is a potentially fatal disease caused in South America by the~     protozoan Leishmania chagasi. In neighborhoods with high exposure rates, the outcome of human~     infection with L. chagasi ranges from asymptomatic to a disseminated wasting disease called~     visceral leishmaniasis (VL). Several studies document familial clustering of VL in~     populations at risk. Segregation analyses favor a genetic over an environmental model for~     susceptibility to L. chagasi infection. A peri-urban outbreak of VL near the Universidade~     Federal do Rio Grande do Norte (UFRN) in Natal, northeast Brazil, has allowed us to identify~     endemic neighborhoods with ongoing transmission of L. chagasi infection. Natal is ideal for~     this study because endemic neighborhoods are easily accessible, people are motivated to~     cooperate with measures to control VL, and other forms of leishmaniasis are not transmitted~     in the region. Dr. Jeronimo of the UFRN, and Dr. Mary Wilson at University of Iowa have~     collected clinical data and DNA from 400 VL families living in these endemic neighborhoods.~     We have created an unprecedented cohort through which we can identify four distinct~     phenotypic responses after L. chagasi exposure. We documented familial clustering of L.~     chagasi infection, and results of both correlation and segregation analyses are consistent~     with the hypothesis that genetic factors predispose, in part, to the diverse clinical~     outcomes after infection. Polymorphism in the TNF locus is associated with developing~     symptomatic as opposed to asymptomatic disease after infection. We recently completed a~     genome-wide scan of the quantitative immune response (DTH) and identified potential linkage~     regions on chromosomes 2, 13, 15 and 19. We have also identified a small linkage peak on~     chromosome 9 for VL. In our ongoing study, we will next perform fine mapping of these regions~     using dense SNPs to identify genes that may determine susceptibility to L. chagasi infection.~     Additionally, we will also analyze candidate genes for association/linkage with~     susceptibility to or protection from L. chagasi disease. We recently identified an~     association on chromosome 5 with the DTH immune response among two linkage disequilibrium~     blocks spanning multiple immune related genes.~   "
245592|NCT00338949|"~     This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a~     standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess~     abdominal fat storage in people with schizophrenia who are at risk for diabetes.~   "
245593|NCT00338936|"~     This study is designed to provide long-term safety and efficacy data for the combination~     doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350~     patients (approximately) who have successfully finished the core trial CVAH631B1303 and~     signed consent for the extension will be enrolled into this study.~   "
245313|NCT00342797|"~     A series of 1,729 retinoblastoma (RB) patients were identified from medical records at~     hospital centers in Boston (1937-84) and New York (1914-84). The study cohort consists of the~     1,604 patients who survived at least 1 year after RB diagnosis. Information was obtained from~     medical records and interviews conducted in 1987 and 1993. RB patients had a 30-fold excess~     risk of another cancer, and a 50% chance of developing a cancer if they survived to 50 years~     of age. Blood samples have been collected from 481 patients, and studies are underway to~     determine if certain mutations in the RB1 genes are associated with increased or decreased~     penetrance or with increased risk of subsequent cancer development. The study population in~     New York is being expanded currently to include patients treated since 1984, and their~     medical records are being abstracted. Blood samples will be collected from the newly~     identified patients who are returning to New York Hospital for a followup RB exam.~   "
245314|NCT00342784|"~     This study will identify genes that predispose men to prostate cancer and affect the rate and~     type of disease spread, the aggressiveness of the disease, and the long-term outcome. Several~     studies show there is a genetic component to prostate cancer susceptibility, and that a~     first-degree relative with prostate cancer increases a man's risk 2- to 3-fold compared to~     those without a family history. The risk is significantly higher if the relative was~     diagnosed at younger than 65 years of age, or if three or more first-degree relatives are~     affected.~      The study will try to locate prostate cancer genes in DNA samples using two methods: linkage~     analysis and association studies. Traditionally, the search for a disease gene begins with~     linkage analysis, in which the aim is to find the rough location of the gene relative to~     another DNA sequence, called a genetic marker, whose position is already known. In genetic~     association studies, genes from a large number of patients are compared with healthy controls~     who are matched by age, race, and geographic region.~      DNA samples for this study come from patients in the two following studies at the Fred~     Hutchinson Cancer Research Center, Seattle, Washington:~      Family study: Participants are families with prostate cancer who have: 1) three or more~     first-degree relatives with prostate cancer; 2) three generations with prostrate cancer~     either through the maternal or paternal side of the family; or 3) two first-degree relatives~     with prostate cancer diagnosed before age 65 or who were African American.~      Population-based study: Participants are patients with prostate cancer and matched healthy~     control subjects.~      The identification of prostate cancer genes important in susceptibility to the disease and~     its aggressiveness may permit earlier detection and development of more directed and~     effective treatments based on underlying genetics.~   "
245315|NCT00342771|"~     This study will examine the association of genetic variants and gene expression patterns with~     the risk of prostate cancer. There will be (It will include?) genotype analysis of blood DNA~     from 600 patients with the disease and from 600 healthy people, and there will be a gene~     expression analysis of prostate tumors. Prostate cancer is a leading cause of death among men~     in Western countries. It is estimated that 220,000 or more new cases of the disease will~     occur in the United States during 2004. The disease incidence is rising. About 25% to 30% of~     the cancers become aggressive. The nonhereditary disease rarely occurs in men who are younger~     than age 40. There are large differences in incidence by geography and race. The highest~     rates are seen among African-American men in the United States. Also, although Caucasians~     have a lower rate of disease incidence and mortality in the United States, the rates among~     them are high compared with rates in some European countries. The reasons for such~     differences are not well understood, but both environmental and genetic risk factors are~     thought to be involved.~      Patients ages 40 to 80 years who have had prostate cancer confirmed within the past 6 months,~     who reside in Baltimore City or adjacent metropolitan counties, and who were born in the~     United States may be eligible for this study. They will be recruited in collaboration with~     the Departments of Pathology and Urology at the University of Maryland and the Baltimore~     Veterans Affairs Medical Center. Those men serving as controls in this study will be~     identified through the Department of Motor Vehicles database and will be matched by age and~     race with the patients who have cancer. The study will include 600 participants with prostate~     cancer and 600 participants in the control group.~      Trained interviewers will administer two questionnaires. The primary questionnaire will be~     used to assess information such as medical and cancer history, tobacco use, current~     medications, occupational history, family medical history, and socioeconomic status. A~     supplemental questionnaire will pertain to patients' exposure to risk factors for prostate~     cancer. It will assess the human body, diet, medical history, family medical history, and~     sexual history. The section on sexual history will be self-administered.~      Patients will undergo collection of blood and urine for various tests. For cancer patients~     with prostate surgery, there will also be a collection of tissue, to be performed at the time~     that the prostate gland is scheduled for surgical removal. The pattern of gene expression~     will be analyzed in low- and high-stage tumors.~      There will be no direct benefit from participating in the study, but participants will~     receive an incentive of up to $75 to participate in the study. No form of treatment is~     involved in this study. However, it is hoped that the study findings will improve~     researchers' understanding of prostate cancer biology with respect to the causes of the~     health variances between African-Americans and Caucasians.~   "
245316|NCT00342758|"~     Early life exposures now appear to be important in modulation of the immune response and~     tendency to develop asthma. We plan to enroll a cohort of children at birth to study early~     life factors in the development of wheezing and respiratory illness during the first six~     years of life in Mexico City. In particular, we will consider the role of early diet~     (particularly antioxidant intake, lactation and obesity), infections, dust mite and cockroach~     antigens, traffic related air pollution, and environmental tobacco smoke. We will also~     consider the potential modifying effect of genetic predisposition with respect to the~     exposures of interest.~      Approximately 6,800 children will be enrolled at birth. The goal is to follow the cohort~     though age 6. To increase the number of expected cases of asthma, we will partially enrich~     the cohort for increased risk of asthma by virtue of having a parent with doctor diagnosis of~     asthma or allergies; the remaining cohort will not be enriched to preserve generalizability.~      Pregnant women enrolled in a prepaid health plan in Mexico City (the Insituto Mexicano de~     Seguridad Social, henceforth referred to as IMSS) will be screened for the study and invited~     to enrolled their newborns when they come for delivery at one of two IMSS hospitals. An~     initial home visit during the first three months of life will include assessment of~     environmental exposures and infant diet. Children will be followed through age six with~     yearly home visits, monitoring of acute lower respiratory illness during the first year of~     life and periodic review of the IMSS medical records.~      We have chosen Mexico City because of the relatively low rates of asthma in the face of~     prevalent exposures to factors that are thought to increase asthma risk in urban areas in the~     United States. These include dust mites, cockroach, airborne pollutants and social factors~     such as low income and young maternal age. This pattern suggests that protective factors may~     be operating in Mexico City that could shed light on the etiology of worldwide childhood~     asthma epidemic. Potential candidates include exposure to certain early infections that shift~     the developing immune system away from the pattern of allergic asthmatic response. We are~     also especially interested in potential protective effects of early nutrition. Exposure to~     ozone in this population is the highest in North American and thus antioxidant intake may be~     especially important. In order to evaluate these protective hypotheses, we will also collect~     information on risk factors believed to be related to increased risk of asthma in US cities~     such as allergens, traffic related air pollutants, and lower respiratory infection with~     respiratory syncytial virus.~   "
245317|NCT00342732|"~     The prevalence of obesity in the United States has reached alarming proportions with 33% of~     adults over the age of 20 being overweight. Obesity is more than twice as prevalent, however,~     in the Pima Indians of Arizona. Although there have been a number of advances in our~     understanding of the genetics of obesity, the environmental influences on the genetic~     expression of obesity requires further investigation.~      In an effort to understand some of the influences on the high prevalence of obesity in the~     Pima Indians, the present study was designed to investigate eating behaviors and food~     preferences, most especially the preference for high fat foods, in sib-pairs of Pima Indians~     who have been previously genotyped in our genomic scan for loci linked to diabetes/obesity.~     Most specifically, we will utilize several questionnaires and methods of assessing eating~     behavior and the preference for high fat foods to create a food intake phenotype. In~     addition, we will study Caucasians so that comparisons can be made between these two groups.~     We will make these evaluations by assessing eating behavior, food preferences including usual~     fat intake and preferences for high fat foods, body image perceptions, and energy~     expenditure. It is hoped that the data gathered from this study will elucidate some of the~     risk factors for the development of obesity among the Pima Indians....~   "
245696|NCT00337558|"~     This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment~     (bladder training) compared to the drug on its own. The study will compare the symptoms of~     OAB by assessing patient diaries and other patient reported outcomes.~   "
245318|NCT00342706|"~     This study will determine the best ways to help teen mothers stay healthy and to increase the~     time between their pregnancies to at least 2 years. It is designed to encourage attitudes and~     behaviors that are generally thought to be related to longer intervals between pregnancies.~     Children of teen mothers generally receive less health care, have lower IQ scores and are~     more likely to enter foster care. They have less supportive home environments and higher~     rates of incarceration and teen childbearing.~      African-American and Latino teenagers living in the Washington, D.C., metropolitan area who~     are pregnant with their first baby may be eligible for this study. Mothers or mother figures~     of the teens also are encouraged to participate. Candidates must be between 15 and 18 year of~     age and speak English.~      Teen mothers enrolled in the study take a urine pregnancy test every 6 months during this~     2-year study. They are randomly assigned to one of the following two groups:~      Usual Care Group: Teens in this group are interviewed by telephone for about 1 hour every 6~     months and for about 15 minutes at 3, 9, 15 and 21 months. The hour-long interview includes~     questions about the teen's feelings and behaviors, risks to her health and well being, and~     how she communicates with her boyfriend and family members. She is also asked about what she~     does to reach personal goals, what she thinks about sexual health, and what support she gets~     from her family, boyfriend, or others. The 15-minute interview is an update to check on the~     teen's health and pregnancy status and to verify contact information.~      Intervention Group: Teens in this group are asked the same questions as those in the usual~     care group; however, they are involved in a project designed to encourage them to set goals~     of furthering their education and training and wait at least 2 years before becoming pregnant~     again. Teens in this group are counseled on learning to communicate and work out problems~     with their family and boyfriend and on how to keep from getting pregnant again soon. The~     participants meet for a 2-hour group session every 3 months at a local health center and are~     contacted frequently by a cell phone, which is provided to them at no cost. The phone~     sessions are about things that are important to the teens, such as problems in their~     relationships, health, sexually transmitted diseases, and preventing another pregnancy too~     soon. The conversations are private and take about 45 minutes.~      Mothers (or...~   "
245319|NCT00342693|"~     Background:~        -  An inadequate filtering system at the Mayak nuclear weapons production facility in~          Ozyorsk, Russia, allowed the release of various radioactive materials, particularly~          I-131 (radioactive iodine) into the city's atmosphere during the 1950s.~        -  A recent pilot study found a higher prevalence of thyroid nodules in Ozyorsk residents~          who were exposed to the radiation in childhood during years of heavy atmospheric~          emissions (1952-1953) than in children exposed in later years (between 1967 and 1991)~          when there were almost no radioactive releases.~        -  Understanding the role of I-131 in the development of thyroid disease is important~          because I-131 is commonly used in medicine (e.g., to treat hyperthyroidism and thyroid~          cancer and to diagnose thyroid disease), and it is the major source of thyroid gland~          exposure in fallout from atomic bomb explosions, nuclear power plant accidents, and~          atmospheric venting from plutonium manufacturing facilities.~      Objectives:~      -To expand the pilot study to include 350 Ozyorsk residents who were exposed in childhood to~     moderate levels of radiation in order to evaluate thyroid disease in relation to the dose of~     I-131 exposure.~      Eligibility:~      -People who were born and living in Ozyorsk, Russia between 1954 and 1955, the period of mild~     radioactive releases from the Mayak nuclear weapons plant.~      Design:~        -  Participants' thyroid gland and structure are examined with an ultrasound examination~          and blood tests.~        -  Participants with a possible thyroid gland disorder are referred to specialists for~          additional diagnostic procedures.~   "
245320|NCT00342667|"~     A major goal of modern perinatal and neonatal medicine is to reduce the rate of developmental~     disabilities, especially mental retardation. Cerebral palsy is frequently associated with~     neurologic abnormalities and mental retardation. Improvements in neonatal intensive care have~     resulted in improved survival of very low birthweight infants but also in an increased~     frequency of cerebral palsy. Prematurity is a leading risk factor for cerebral palsy. Two~     thirds of preterm neonates are born to mothers with preterm labor with intact membranes or~     preterm premature rupture of membranes. A growing body of evidence suggests that these~     conditions are heterogeneous. This is an observational cohort study designed to identify the~     mechanisms of disease in patients with preterm labor/contractions and preterm premature~     rupture of membranes and to describe the relationship between clinical, biochemical,~     histological, biophysical parameters and the development of infant neurological disorders.~   "
245321|NCT00342654|"~     Two large, nutritional intervention trials were conducted in Linxian, China between~     1985-1991. These trials tested the effect of multiple vitamins and minerals in the prevention~     of esophageal cancer in a population with the highest known rate for this disease in the~     world. Results from the trials showed that Beta-carotene + Vitamin E + selenium reduced total~     mortality, total cancer mortality, and stomach cancer incidence and mortality.~     Multivitamins/minerals also showed reduction in premalignant lesions. Preliminary follow-up~     data obtained for the time period after cessation of intervention in 1991 suggests that the~     observed benefit for total and cancer mortality is reduced but that the benefit for stomach~     cancer remains.~      The objectives of the follow-up study are: (1) to continue to determine cancer incidence and~     all causes of mortality in trial participants after intervention to permit examination of~     potential effects of the interventions on total and cause-specific mortality and cancer~     incidence in the post-intervention period; (2) to conduct a cross-sectional nutritional~     survey in a subsample of living trial participants to evaluate their nutritional status,~     asses the validity of dietary questionnaires, and relate neurologic status to vitamin B12~     plasma levels; (3) to collect a blood sample from all living trial participants to permit~     further etiologic investigations of genetic and environmental hypotheses; and (4) to perform~     nested case-control studies of selected genetic and environmental hypotheses.~      To accomplish the objectives of the follow-up study, we will: (1) determine updated vital~     status and cancer status data on all trial participants via monthly checks of village doctor~     records and quarterly checks of the Linxian Cancer Registry; conduct a Vital/Cancer Status~     Interview Survey among all (n-34,000 trial participants (or their surrogates); identify,~     collect, and store all available diagnostic materials for trial participants identified as~     having developed cancer or died with cancer during the follow-up period; (2) conduct a~     Nutritional Survey on a subsample (n-1000) of living trial participants that will include (a)~     a physical exam and brief medical history, (b) a neurologic history, (c) a cognitive function~     exam, (d) a hair/mouth skin exam, (e) a neurological exam, (f) a nutritional questionnaire,~     and (g) collection of a blood sample for hematologic/biochemical analyses; (3) conduct a~     Blood Collection Survey of all living trial participants (n-23,000) to obtain (a) a physical~     exam and brief medical history and (b) a single 10-ml blood sample for separation and~     preservation as WBCs (both viable and nonviable), RBCs, and plasma for genetic (e.g.,~     xenobiotic polymorphisms) and environmental (e.g., plasma ascorbic acid) hypothesis testing;~     and (4) perform Nested Case-Control Studies of selected genetic and environmental hypothesis~     related to the etiology and prevention of esophageal cancer and stroke. These will be done~     using serum from the new cancer and stroke cases (-2500) and controls (-2500) previously~     identified from 1991-1996, as well as using new cancer and stroke cases and controls for the~     period 1996-2004 (-9000).~      The followup for endpoints will continue monthly for an additional 5 years (through the year~     2003). The Nutritional Survey and Blood Collection Survey will be conducted in the spring of~     1999. The Nested Case-Control studies will be performed annually beginning in 2000, and the~     Vital/Cancer Interview Survey will be conducted in the Spring of 2001.~   "
245322|NCT00342641|"~     This study will investigate the possible relationship between infection with hepatitis C~     virus (HCV) and the development of certain hematologic cancers (Non-Hodgkin's lymphoma,~     Hodgkin's lymphoma, chronic lymphocytic leukemia, multiple myeloma) and thyroid cancer. HCV~     causes chronic hepatitis, cirrhosis, and liver cancer. It is transmitted primarily through~     injection drug use and transfusion of infected blood. Studies have shown that HCV may also be~     linked to hematologic cancers and thyroid cancer.~      This retrospective study will examine medical records from veterans with and without HCV~     infection who previously received treatment in the Veterans Administration medical system.~     Data collected on each subject will include the subject's race, sex, age and era of military~     service, presence of liver disease or thyroiditis at their baseline clinic visit, number of~     inpatient visits in the past 5 years and outpatient visits in the past year, and the presence~     of various specified cancers. The prevalence of cancer and other conditions among~     HCV-infected subjects and non-HCV infected subjects at baseline and the subsequent~     development of the cancers of interest in these two groups will be compared and analyzed for~     a possible causal relationship.~   "
245323|NCT00342628|"~     The purpose of this study is to evaluate the safety, immunogenicity, and compatibility of our~     Vi-rEPA conjugate administered to infants with their routine vaccinations.~      We propose to recruit 300 full term healthy newborns in Vietnam and randomly divide them to~     receive Vi-rEPA plus DTP, Hib-TT (not yet used in Vietnam) plus DTP, or DTP alone. Consent is~     obtained following interviews of mothers during prenatal visits, or after delivery. All~     vaccines will be administered at 2, 4, and 6 months. A booster of Vi-rEPA or Hib-TT conjugate~     will be administered at 12 months of age and reactions monitored at 6, 24 and 48 hours after~     each injection. Maternal and cord blood samples are collected during labor and at delivery.~     Blood will be taken at 7, and 12 months of age from all study infants and at 13 months from~     infants injected with Vi-rEPA or with Hib-TT at 12 months. The blood samples will be assayed~     for Vi, Hib, diphtheria, tetanus and pertussis antibodies.~      The levels of serum IgG anti-Vi elicited by Vi-rEPA administered to infants by the above~     schedule will be compared to those elicited by this vaccine in 2 to 5 year-olds in the~     efficacy trial conducted in Dong Thap Province, Vietnam.~   "
245616|NCT00338637|"~     Randomised double blind study of two parallel groups,one of the groups trained with the full~     APOS kit (a shoe with an additional bio mechanical device)~      The control group trained with the Apos shoe without the bio mechanical device. both groups~     will be checked at the beginning of the study, one month later and at the end of the study~     after two months. The tests include neurological test, functional test(FSST,up and go test~     and berg balance test) gate analysis and quality fo life (rays) test.~   "
245324|NCT00342602|"~     This study will identify genetic factors associated with the development of progressive~     multifocal leukoencephalopathy (PML) in patients with acquired immunodeficiency syndrome~     (AIDS). PML is a life-threatening infection of the brain that affects about 5 percent of~     untreated patients with AIDS. Its symptoms include mental deterioration, vision loss, speech~     disturbances, ataxia (inability to coordinate movements), paralysis, and coma. PML is caused~     by a polyomavirus called the JC virus.~      It is estimated that up to 80 percent of the human population has been exposed to the JC~     virus, but the disease is very rare. The virus only becomes active in people who have~     compromised immune systems, such as those undergoing immune suppressive chemotherapy for~     cancer and those with damaged immune systems due to HIV.~      Patients who have participated in the Multicenter AIDS Cohort Study may be eligible for this~     study, as well as healthy normal volunteers who will serve as controls. The study will review~     clinical information from patients and analyze genetic factors from both patients and control~     subjects to investigate genes associated with AIDS and JC virus infection.~   "
245325|NCT00342589|"~     This study will examine the effectiveness of a new laboratory method for detecting~     pneumocystis organisms in a salt-water (saline) oral wash. Pneumocystis infection in people~     with weakened immunity especially patients with HIV infection or cancer, organ transplant~     recipients and people receiving immune suppressing therapy can cause life-threatening~     pneumonia. Currently, pneumocystis infection is diagnosed by sputum analysis or~     bronchoalveolar lavage. For the sputum analysis, patients are induced to produce a sputum~     sample (liquid discharge from the lung) using a saline mist; however, many hospitals lack the~     expertise to perform this procedure. The second method, bronchoalveolar lavage, involves~     inserting a flexible tube into the lung and injecting saline to produce a specimen for~     diagnosis. This method, however, is time-consuming and can be uncomfortable. New techniques~     may allow the use of an oral wash to diagnose pneumocystis, even though an oral sample~     contains far fewer organisms than are obtained with the current methods. This study will~     examine whether new techniques, such as nucleic acid amplification, may enable a simple oral~     wash to be used effectively for diagnosis of pneumocystis infection.~      Patients 3 years of age and older with weakened immunity who have acute pneumonia may be~     eligible for this study. In addition, people at increased risk of infection with~     pneumocystis, including health care professionals, family members of patients, and other~     patients in health care facilities, may participate.~      Participants will have a medical history and review of medical records to determine their~     health status and determine if they have had recent respiratory problems or documented PCP.~     They will then provide an oral wash sample. For this procedure, subjects first rinse their~     mouth well. Then, they vigorously swish 50 milliliters of saline for 5 to 10 seconds and~     immediately repeat the procedure to provide two specimens. Washes may be requested daily,~     weekly, monthly, or for a period of time to be specified. Participants will also have two~     tubes of blood drawn (total of 20 milliliters, or 4 teaspoons) to test for evidence of~     pneumocystis.~      Although no other tests are required for this protocol, participants may be asked to provide~     optional add'l samples, as follows:~      If a sputum or bronchoalveolar lavage sample is required in the course of the patient s~     clinical mgmt, enough material will be obtained, if possible, for research purposes as well~     as what is needed for routine care.~      An induced sputum sample may be requested just for this protocol. For this procedure, a mask~     with a saline mist is placed over the face, inducing a cough that, it is hoped, will produce~     sputum from the lungs.~   "
245326|NCT00342576|"~     Patients admitted on this protocol will have, or be suspected of having, one of the lymphatic~     filarial infections affecting humans. After routine clinical evaluation they will be studied~     in depth immunologically, and their blood cells and/or serum will be collected to provide~     reagents (eg., specific antibodies, T cell clones, etc.) that will be used in the laboratory~     to address the broader questions of immunodiagnosis, immunoregulation, immunopathology and~     immunoprophylaxis. Careful observations of the patients' clinical and immunologic responses~     to therapy will be made, as well as long-term follow-up of these changes. It is anticipated~     both that the patients will receive optimal clinical care for their infections and that the~     specimens collected from them will prove to be valuable reagents for the laboratory studies~     of the immunologic responses unique to filarial or other helminthic infections.~   "
245327|NCT00342563|"~     The purpose of the study will be to evaluate the efficacy of mecamylamine in reducing alcohol~     consumption in smoking and non-smoking alcohol dependent patients.~      We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption~     than placebo. We further hypothesize that mecamylamine will be effective in reducing both~     alcohol consumption and smoking in a subset of alcoholics who also smoke.~   "
245328|NCT00342550|"~     Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators~     have reported that ultrasound evaluation of the cervix can predict the risk of preterm~     delivery. Three-dimensional ultrasound may provide additional information about how to best~     counsel parents about the chances of premature birth. This technology has the capability for~     accurate volume measurements of irregular structures that is superior to conventional~     ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better~     characterize cervical changes and the risk for preterm delivery.~      Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by~     three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm~     labor will be prospectively studied to characterize cervical morphology and volume as~     predictors of preterm delivery risk. These results will be correlated with placental~     pathology and pregnancy outcome. We will also compare the performance of conventional~     two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This~     information is expected to improve our understanding about the nature and timing of cervical~     volume changes in relation to pregnancy outcome....~   "
245329|NCT00342537|"~     This study is a collaboration between the Clinical Genetics Branch of the National Cancer~     Institute and the International Testicular Cancer Linkage Consortium (ITCLC). The primary~     goal of the ITCLC is mapping and cloning susceptibility genes for familial TGCT. The~     objectives of the current study are to:~        -  Identify the genes responsible for testicular germ cell tumor (TGCT) (testicular cancer)~          in families with an inherited tendency to develop the disease~        -  Determine if the genes which predispose to developing testicular cancer also increase~          the risk of other specific types of cancer among first- and second-degree relatives of~          patients with TGCT~        -  Determine if the microscopic appearance of familial testicular cancers is different from~          that of non-familial TGCT~      Patients and family members recruited by the ITCLC in the United Kingdom, the Netherlands,~     and Norway are eligible for this study. Individuals with the following medical criteria may~     participate:~        -  Patients with testicular germ cell cancer who have at least one other blood relative~          with the disease~        -  Family members of patients (first- and second-degree relatives)~      Participants undergo the following procedures:~        -  Fill out questionnaires for providing information about a history of cancer in all blood~          relatives, including parents, siblings, children, grandparents, aunts, uncles, and~          cousins, and a history of undescended testes in male blood relatives. Participants may~          be asked permission to contact family members to request their help in the study as~          well.~        -  Provide a blood sample for genetic testing related to TGCT (except in children under 16~          years old).~        -  Review of medical records and examination of tumor specimen (patients with TGCT only).~        -  Confirmation of the diagnosis of other types of cancer in these same families (medical~          records, pathology repots)~        -  Review of the testicular cancer tissue obtained at the time of surgery from members of~          multiple case families, and comparison of these findings with a series of TGCT which~          have developed in men without a family history.~   "
245617|NCT00338624|"~     The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended~     release tablets 10 mg plus tamsulosin HCl 0.4 mg in the treatment of lower urinary tract~     symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from~     baseline to Week 12 or the Final Visit.~   "
245330|NCT00342524|"~     The purpose of this study is to collect plasma by apheresis from patients who have recovered~     from Severe Acute Respiratory Syndrome (SARS). This plasma will be processed into a~     SARS-antibody enriched intravenous immune globulin (IVIG) product. This product will then be~     available for use in a clinical trial if a SARS epidemic recurs.~      Potentially eligible participants are people between 18 and 56 years of age who have~     recovered from SARS. Potential participants will undergo three sequential screenings to~     determine their eligibility for this study. Eligible participants will then be scheduled for~     plasmapheresis. After apheresis, additional testing will be performed on a sample of the~     source plasma. Once the sample has been tested and cleared, the source plasma will be shipped~     to the United States to the storage facility and finally to the site of manufacturing of the~     IVIG product. Participants may donate plasma again after 14 days.~      The study will not have a direct benefit for participants. However, participation may help~     develop a treatment that could be useful to other people who become infected with SARS.~   "
245331|NCT00342511|"~     This study will evaluate a method of testing for human papillomavirus (HPV) DNA. For women~     who have had Pap test results that are abnormal, a new test can be done for HPV, that is,~     viruses that sometimes cause bumpy or flat warts. Such infections all usually disappear by~     themselves in 1 or 2 years if someone's Pap test shows a mild abnormality. But if the HPV~     does not go away, the infection can slowly lead to cancer of the cervix. Through this study,~     researchers will examine patients in conjunction with a colposcopy, that is, a diagnostic~     tool to determine the cause of abnormal Pap test results. The researchers hope to improve on~     the efficiency of detecting HPV and reducing the risk of cervical cancer.~      Patients ages 21 and older who are not pregnant and who have not had a hysterectomy and who~     are attending a colposcopy clinic may be eligible for this study. This study will enroll 150~     patients. Two pilot studies will be done: one at the Cleveland Clinic, with the use of the~     POI sampler (Preventive Oncology International ) and the other at the University of Arizona,~     with the use of the Fournier sampler.~      In the study part that uses the POI sampler, patients will be recruited from the existing~     colposcopy schedule. For the Fournier sampler, patients will be recruited as they attend~     their scheduled colposcopy visit. During the procedure, the doctor will collect two~     (Cleveland Clinic) or three (University of Arizona) specimen from the patients while the~     patients are sitting. A speculum is not placed in the vagina at that time. Then the doctor~     will conduct a routine pelvic exam, with the use of a speculum, while the patients are lying~     down, and perform the colposcopy. One final specimen will be collected before the the~     colposcopic evaluation. Those three or four specimens will be used just for research~     purposes, and they make up the only part different from the regular colposcopy exam. The~     pelvic exams may sometimes be slightly uncomfortable, and patients may have temporary vaginal~     spotting of blood afterward. The collection of additional specimens may also cause slight~     discomfort.~      The research specimens, which will not be labeled with information that directly identifies~     the patients, will be stored at a repository sponsored by NIH. Those specimens would be~     tested now or in the future.~      Participants will be told about the results of their tests as part of the routine management~     of their abnormal Pap results. Women participating at the University of Arizona will receive~     $25 for the time they spend in the study. Benefits that patients receive from being part of~     this study include helping researchers to discover new ways to prevent cervical cancer.~   "
245332|NCT00342498|"~     We propose to analyze a DNA sample for mutations in the estrogen receptor gene from a patient~     who appears insensitive to estrogen hormone treatment.~   "
245333|NCT00342485|"~     Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and~     patients who present with different diseases that involve or implicate the immune system~     dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in~     vitro for a number of functional parameters, including generating soluable factors that~     inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T~     cell death. The purpose of such studies is to obtain insight into the mechanisms of natural~     resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.~   "
245334|NCT00342472|"~     The overall goal of this project is to determine whether polycyclic aromatic hydrocarbons~     (PAHs) are contributing to the high rate of esophageal cancer in Linxian, China.~      Esophageal cancer is one of the most fatal cancers worldwide with Linxian, China having one~     of the highest rates in the world. In the United States esophageal cancer causes~     approximately 10,000 deaths each year. It is the fourth most common cause of cancer death in~     black males and the eighth leading cause of cancer death in men of all races. Although~     several recent studies have identified some of the molecular changes associated with~     esophageal cancer, its prevention and treatment within high risk groups continues to be~     limited by our inability to identify specific etiologic agents.~      Human exposure to PAHs, including benzo [a]pyrene (B[a]P), is associated with an increased~     rate of skin, lung, and upper GI tumors and also with an increased mortality from causes~     related to atherosclerosis. Evidence, including the preliminary results from histologic and~     food analysis pilot studies, supports the idea that this region's high rate of esophageal~     cancer may be related to long-term, high-level exposure to PAHs via inhalation of air-borne~     pollution and ingestion of food cooked with soft coal.~      Thus, to assess the association of PAHs with the high rate of esophageal cancer in Linxian,~     China, we plan to analyze samples of food for the presence of PAHs, samples of blood for Hb~     adducts (a marker of long-term PAH exposure), samples of urine for 1-OH-Pyrene glucuronide (a~     maker of short-term PAH exposure), and samples of coal for characteristics that may be~     associated with increased carcinogenesis. We will also administer environmental~     questionnaires that will include questions about the type of fuel used for cooking and~     heating, the location and type of stove and/or heating unit (i.e., vented versus unvented),~     and time spent cooking.~   "
245335|NCT00342446|"~     To assess the relations of infertility causes and treatment to cancer risk, we will conduct a~     retrospective cohort study of approximately 12,000 women evaluated for infertility between~     1965-1988. These women will be ascertained from several large infertility clinics and private~     practices in various geographic locations in the United States: Boston, Chicago, Detroit, New~     York, and Palo Alto. These practices were selected on the basis of their having large number~     of patients who received ovulation stimulating drugs many years in the distant past.~     Abstractors reviewed clinic medical records to identify eligible study participants and~     abstract data needed to classify causes of infertility and document therapies employed. Using~     a variety of tracing sources (including the National Death Index, credit bureaus, and~     postmasters), the vital status and location of the study subjects were determined. Subjects~     who were traced and identified as alive are being sent a detailed questionnaire that requests~     information on their health status as well as on a number of lifestyle practices. For~     subjects who report a cancer, medical verification is being sought from the diagnosing~     physicians and/or facilities. Death certificates are being sought for deceased subjects.~   "
245363|NCT00342056|"~     This study will examine DNA from cancer patients previously treated with Gleevec to look for~     a variation (mutation) of the ABCG2 gene that may render the drug less effective in certain~     patients. Gleevec is used to treat chronic myeloid leukemia and gastrointestinal tumors.~     Although most patients respond to treatment, many with advanced disease develop resistance to~     the drug. It is thought that in some patients this resistance results from the action of a~     protein that causes Gleevec to be pumped out of the cells, reducing its usefulness.~      Patients enrolled in clinical trials of Gleevec at the National Cancer Institute and at other~     participating institutions are eligible for this study.~      DNA from patients' blood samples are analyzed for the ABCG2 gene and correlated with clinical~     data, such as the patient's age, race, disease state, weight, height, and body surface area.~     It will also look at the drug dose, how often the drug is given, the duration of treatment,~     side effects and other medications taken.~   "
245336|NCT00342433|"~     Although compelling evidence from laboratory studies suggests that androgens play a major~     role in prostate carcinogenesis, epidemiologic studies in humans (almost exclusively~     serologic studies) have been unable to confirm the hormonal hypothesis. The major limitation~     in these serologic studies may stem from difficulty in measuring androgenicity directly at~     the target site - the prostate. If circulating hormones do not reflect intraprostatic hormone~     levels or androgenicity, it is not clear how we should interpret results from serum/plasma~     measurements, and it is unlikely that future serologic studies can clarify the role of~     hormones in prostate cancer etiology.~      This study is a comprehensive methodologic study designed to collect venous blood and~     prostatic tissue from 650 patients (100 Chinese, 500 American, and 50 Italian) undergoing~     prostatic surgery (radical prostatectomy, cystoprostatectomy, or transurethral resection of~     the prostate) in order to correlate prostate tissue with serum hormone levels, and with~     polymorphisms of hormone-related genes (including the androgen receptor and SRD5A2, the gene~     encoding 5-alpha-reductase Type II), and to examine characteristics (such as age, smoking,~     body size) that might affect serum-tissue correlation. We plan to study the following~     hormones: testosterone, dihydrotestosterone, androstenedione, androstandediol glucuronide,~     estradiol, estrone, and estrone sulfate. Levels of androgen receptor and its associated~     protein in prostatic tissue will also be measured to provide a better estimate of total~     intraprostatic androgenicity. We also plan to collect saliva from 100 of these cases in the~     Washington, D.C. area and 100 of these cases in China, to assess whether this non-invasive~     tissue collection method is valid for hormone measurements. Finally, urine collection from~     100 of these Chinese men is planned for study of androgen metabolites.~      Additionally, we plan to include 200 Chinese subjects for blood collection without tumor~     tissue for gene polymorphism studies, bringing the total number of subjects enrolled to 850.~      For the 650 subjects providing prostate tissue, 30-ml of fasting blood will be collected for~     hormone and polymorphism analyses, and tissue will be collected at surgery. A 15-minute~     interview will be conducted to elicit information on demographic characeristics, tobacco and~     alcohol use, body size, and medical history.~      The proposed methodologic study will be the first of its kind to investigate androgenicity in~     target tissues directly, and the correlation of target tissue androgenicity with circulating~     levels of hormones and polymorphisms of hormone-related genes in a well-designed~     epidemiologic study. This study will provide critical information to guide future analytic~     studies on hormones and prostate cancer.~   "
245337|NCT00342407|"~     Flight attendants may be at an increased risk of breast and other cancers due to work-place~     exposures including cosmic radiation and circadian rhythm disruption form traveling across~     multiple time zones. This cancer incidence study will determine whether female flight~     attendants are at increased risk of breast and other cancers and whether the risk is~     dose-related. The study will include a cohort of approximately 10,000 women who were employed~     as flight attendants for one or more years.~      Breast cancer cases will be identified from telephone interviews of living subjects and~     next-of-kin of deceased subjects, as well as from death certificates. The interview will also~     provide information about non-occupational risk factors for breast cancer such as parity.~     Both internal and external comparisons will be made. The primary analysis will evaluate the~     risk associated with occupational exposure within the cohort, controlling for~     non-occupational risk factors by stratification or modeling. The secondary analysis will~     compare the incidence of breast cancer in the cohort to that in the general population, with~     adjustment for factors such as lower parity which might increase breast cancer risk in the~     cohort independent of occupational exposure to cosmic radiation and circadian rhythm~     disruption. The risk of other ionizing radiation-related cancers, such as leukemia, lung~     cancer, and thyroid cancer, among flight attendants will also be evaluated. The results of~     the study will apply to female flight crew and frequent fliers.~   "
245338|NCT00342394|"~     This protocol describes an exposure assessment study of farmers in North Carolina and Iowa~     who personally apply the fungicides captan, thiophanate-methyl, and benomyl to apple and~     peach orchards. The exposure assessment will include environmental measurements as well as~     biological monitoring data. The biomonitoring data will be based on 24-hour urinary~     metabolites of the three fungicides selected for study. The study is being done in~     collaboration with the Argicultural Health Study (AHS), a large prospective health study of~     licensed private (farmer) and commercial applicators, and the spouses of private applicators.~     The AHS is sponsored by the National Cancer Institute, the National Institute of~     Environmental Health Sciences and the Environmental Protection Agency. The study described~     here will be conducted by the National Institute of Occupational Safety and Health.~      In summary, the objectives of this study are 1) to measure actual exposures to the target~     fungicides using both environmental and biological measures of exposure, 2) to identify and~     quantify major determinants of exposure, 3) to describe within- and between-worker exposure~     variability, and 4) to evaluate, to the extent possible, agreement between exposure estimates~     computed using the AHS exposure algorithms and exposure estimates based on actual~     measurements.~   "
245339|NCT00342381|"~     The purpose of this study is to investigate fatigue in patients with multiple sclerosis (MS)~     and to determine the correlation between the symptom and cerebral changes.~   "
245340|NCT00342368|"~     Mechanical ventilation through an endotracheal tube is a lifesaving procedure for acute~     respiratory failure. However endotracheal intubation increases patient's discomfort and~     stress, and represents one of the most important predisposing factors for developing~     nosocomial bacterial pneumonia.~      In conscious and cooperative patients non invasive positive pressure ventilation (NPPV) is a~     safe and effective mean for treating patients with acute respiratory failure (ARF), improving~     gas exchanges and reducing the rate of complication related to mechanical ventilation. Facial~     mask, that is the conventional interface for NIV, may induce intolerance because of pain,~     discomfort or claustrophobia leading to discontinuation of noninvasive ventilation and~     endotracheal intubation. Thus the improvement of the interface between patient and ventilator~     seems crucial to achieve a good tolerance allowing the prolonged application of noninvasive~     ventilation. Attempting to improve tolerability of patients we used a new interface~     consisting in Helmet made in latex-free PVC.~      No prospective randomized controlled study has been published on the comparison between~     Continuous Positive Airways pressure (CPAP), delivered by an helmet and the medical treatment~     with Oxygen supplementation to treat early acute respiratory failure and acute lung injury.~      Aim of the present protocol is to compare the efficacy of CPAP delivered with helmet and~     conventional medical treatment with oxygen supplementation via Venturi mask, to prevent ETI~     in patients with early hypoxemic ARF ( paO2 /FiO2 below 300).~   "
245431|NCT00341146|"~     The objective of this study is to characterize genes associated either with susceptibility or~     resistance to the development nasopharyngeal carcinoma (NPC) in a Chinese population where~     the incidence of NPC is as high as 50 in 100,000. NPC has been and remains a unique model of~     human malignancy for understanding a multi-step carcinogenic process involving a ubiquitous~     virus (Epstein-Barr virus), environmental carcinogens, and an NPC susceptibility gene. Up to~     95% of all NPC patients at early or late stage of the disease have IgA antibodies directed to~     the EBV virus VCA (viral capsid antigen). Environmental factors have also been implicated as~     significant risk factors in the development of NPC. In addition, certain alleles in HLA genes~     have shown associations with NPC, perhaps in concert with a family of T-cell receptor genes~     (TCR). Other data suggest that a microsatellite marker on Chromosome 6 may be associated with~     an NPC-disease associated gene.~   "
245341|NCT00342355|"~     This study will determine how well four different antiretroviral drug therapies work in~     patients with advanced HIV disease. The trial is part of the South Africa-U.S. Project~     Phidisa Programme - a collaboration between the South African Military Health Service (SAMHS)~     of the South African National Defense Force (SANDF), the U.S. Department of Defense, and the~     U.S. National Institutes of Health - to help prevent HIV transmission among South African~     military and civilian employees and their families.~      Members of the SANDF with HIV infection may be eligible for this study. HIV-infected family~     members who are 14 years of age and older may also participate. All participants must have a~     CD4 count of less than 200 or an AIDS-defining illness.~      Participants are randomly assigned to one of the following four antiretroviral drug regimens,~     which require taking 5 pills or more every day:~        -  AZT (zidovudine) + ddl (didanosine) + EFV (efavirenz)~        -  AZT (zidovudine) + ddl (didanosine) + r/LPV (lopinavir/ritonavir)~        -  D4T (stavudine) + 3TC (lamivudine) + EFV (efavirenz)~        -  D4T (stavudine) + 3TC (lamivudine) + r/LPV (lopinavir/ritonavir)~      Patients are followed for up to 6 years. Clinic visits are scheduled once a month for the~     first 3 months and then once every 3 months for the next five years. Patients undergo a~     medical history, physical examination, and blood tests at each visit, and complete~     questionnaires of behavior, quality of life, and force readiness every year.~   "
245342|NCT00342342|"~     This study will examine blood specimens from patients with various eye disorders who~     previously participated in the Beaver Dam Eye Study to try to identify genes responsible for~     these disorders. The Beaver Dam study was designed to determine the incidence and causes of~     age-related eye conditions, including cataract (changes in the lens of the eye that can~     impair vision); retinopathy (diseases of the retina - the thin layer of tissue that lines the~     back of the eye); age-related maculopathy (degeneration or atrophy of the macula - the center~     part of the retina responsible for fine vision); and impaired vision. Findings from this~     study and others have shown that age-related eye disorders often run in families, indicating~     a genetic component in their development.~      All participants in the Beaver Dam study who had family members in the study may be included~     in the current NHGRI study. The Beaver Dam study included residents of the township of Beaver~     Dam, Wisconsin, who were between 45 and 84 years of age at enrollment. Participants had~     thorough eye examinations and blood samples drawn at baseline and 5 and 10 years after the~     baseline evaluation. Fifteen-year follow-ups will start in 2003.~      This study will analyze data and blood samples previously collected from Beaver Dam study~     participants to identify genes related to numerous age-related visual traits. No new~     participants will be recruited.~   "
245343|NCT00342329|"~     The purpose of this study is to examine hormonal and environmental risk factors (and possible~     gene-environmental interactions) involved in the etiology of lupus nephritis. Our study will~     focus on exposures to occupational and environmental agents that have been linked to the~     development of systemic lupus erythematosus (SLE) or renal disease (e.g., silica dust,~     smoking). We will also assess potential gene environment interactions. We will examine these~     exposures in 100 patients with renal biopsy with documented proliferative or membraneous~     nephritis. We will compare exposures in the lupus nephritis patients to lupus patients who do~     not have nephritis and to normal controls who have participated in the Carolina Lupus Study.~     One hundred lupus nephritis patients (age 18 years or older, of both genders and all races)~     will be identified through the Glomerular Disease Collaborative Network (GDCN)~     Nephropathology database and participating nephrologists at the Medical University of South~     Carolina, Duke University Medical Center and the East Carolina Medical School.~   "
245344|NCT00342316|"~     This study compares overall survival between patients with acute myeloid leukemia, who are in~     complete remission following initial treatment with chemotherapy and whose remission is~     maintained either with a transplantation of stem cells obtained from a sibling or unrelated~     donor or with standard treatment, which is additional chemotherapy.~      The study hypothesis is that the group transplanted with stem cells from a donor will have a~     superior survival compared with patients treated with standard of care.~   "
245345|NCT00342303|"~     We will test the following hypotheses:~        1. The activity of the desaturating/elongating enzymes assessed by the in vivo conversion~          of deuterated a-linolenic and linoleic acids to DHA and AA, respectively, will be~          related to the duration of gestation and to postnatal age.~        2. Dietary w-3 and w-6 LCPUFAs in human milk or DHA and AA supplemented formula will~          inhibit the desaturation/elongation of deuterated a-linolenic and linoleic acids~          demonstrating in vivo inhibition of the metabolic pathway by respective products.~      Present evidence suggests that the parent essential fatty acids (EFA), linoleic acid (18:2~     w-6) and a-linolenic acids (18:3 w-3) are insufficient to fully satisfy EFA nutrition during~     early life in the human. A possible need for long chain (LC, longer than 18 C chain length)~     EFAs in the human is suggested by the accretion rates of elongated and desaturated products~     in the developing fetus; the altered plasma and red cell fatty acid patterns, and the~     abnormal visual function observed in infants receiving solely the parent EFAs; and by the~     relatively high concentration of LC EFAs in human milk. Most milk formula, as compared to~     human milk, are lower in oleic acid, higher in linoleic, have little a-linolenic acid and~     virtually no LC w-3 or w-6 polyunsaturated FA (LC PUFA). This study will evaluate the~     capacity of human infants to form w-3 and w-6 LCPUFAs from the parent EFAs as affected by~     developmental stage and dietary EFA supply. The precursors will be labeled with deuterium and~     the products analyzed by gas chromatography / mass spectrometry GC/MS. The main products of~     the desaturation / elongation pathway are docosahexaenoic (DHA) and arachidonic (AA) acids~     for the w-3 and w-6 series, respectively. Infants will be fed human milk or formulas with or~     without supplemental LCPUFAs as part of a study to evaluate the effect of EFAs on CNS~     functional development. Infants included in this study of the effect of developmental stage~     on EFA desaturation/elongation will be 2-5 days of age (before any fat is administered~     enterally or parenterally) and 28, 32, 36 or 40 weeks gestation. In addition, infants born at~     28 and 40 weeks gestation will be studied 2 and 6 weeks postnatally after dietary fat has~     been provided for at least 7 days and energy intake is sufficient to assure growth. To~     evaluate the effect of dietary EFA on DHA and AA formation we will assess elongation/~     desaturation in infants receiving 3 diets: human milk (which contains w-3 and w-6 LCPUFAs);~     cow milk based formula providing 18:2 w-6 and 18:3 w-3 but no LCPUFAs; or formula~     supplemented with added LCPUFAs (DHA and AA). This study should provide new information on~     the effects of developmental stage and w-3 and w-6 LCPUFA supply in determining the activity~     of EFA elongation/desaturation in the human. This knowledge may help in improving early~     neonatal nutritional practices to assure meeting the EFA needs of the developing CNS.~   "
245448|NCT00340912|"~     Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial~     growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their~     donor but can be used for experiments where study conditions are much more precisely~     controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima~     Indians for two purposes. Firstly, to look for an in vitro system to measure insulin~     resistance, the underlying abnormality in Pima diabetics. Secondly, to look for biochemical~     markers of diabetes or obesity in Pimas employing two dimensional electrophoresis techniques.~   "
245633|NCT00338416|"~     The purpose of this study is to determine the effectiveness and safety of PROCRIT (Epoetin~     alfa) at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb)~     of 12 g/dL (Initiation Phase), followed by a dose of 80,000 Units once every three weeks~     (Q3W) to maintain a Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients~     receiving chemotherapy.~   "
245346|NCT00342290|"~     Early pregnancy is associated with numerous physiologic alterations - many of which are~     required to establish normal pregnancy outcome. Three-dimensional ultrasound may provide new~     opportunities to better characterize some of these early changes. This noninvasive method~     allows one to arbitrarily scan through a digital ultrasound volume data, visualize organs~     from different perspectives, and render anatomical features through computer processing.~     Retrospective measurement of distances and volumes are even possible in the physical absence~     of the patient.~      New information provided by three-dimensional ultrasound may lead to improved understanding~     about how to counsel parents regarding early pregnancy complications such as bleeding. For~     example, vaginal bleeding complicates approximately 15-20% of first trimester pregnancies. A~     common association is subchorionic hemorrhage which is associated with increased risk for~     miscarriage, preterm delivery, preterm premature rupture of membranes, stillbirth, and~     placental abruption. Several studies have attempted to characterize subchorionic hemorrhage~     by conventional two-dimensional ultrasound which is not particularly well-suited for accurate~     measurement of small irregular hematomas. Consequently, there has been considerable debate~     about the significance of this finding especially in asymptomatic women who undergo prenatal~     ultrasound examination for other reasons.~      This protocol will attempt to identify prognostic indicators of adverse pregnancy outcome. A~     maximum of 400 pregnant women up to 20 weeks' gestation with sonographically detected~     subchorionic hemorrhage will be serially studies to characterize sac volume, placental~     volume, hematoma volume, and placental blood vessel patterns by 3DUS techniques. These~     results will be correlated with pregnancy outcome, hormonal markers, and placental pathology.~     This information is expected to improve our understanding of the natural history of~     subchorionic bleeding and spontaneous miscarriages as well as prognostic factors influencing~     pregnancy outcome in both symptomatic and asymptomatic women.~   "
245347|NCT00342277|"~     The understanding of the biological mechanisms underlying preterm birth is very limited,~     making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies~     between 6% to 11% in singleton pregnancies and 64-93% of preterm deliveries occur after the~     spontaneous onset of labor (preterm labor) (1). The risk factors associated with preterm~     birth include demographic variables such as ethnic group, past obstetric history, and~     complications of the current pregnancy such as infection and fetal congenital anomalies. The~     current study aims to investigate the basic mechanisms of preterm labor by systematically~     cataloging the changes in expression levels of all expressed genes whose sequences are~     available. The goals will be accomplished by using microarray technology followed by~     quantitative real-time PCR, in situ PCR, in situ hybridization and proteomics.~   "
245348|NCT00342264|"~     Diesel exhaust has been classified as a probable carcinogen by the International Agency for~     Research on Cancer and as a potential carcinogen by the National Institute for Occupational~     Safety and Health (NIOSH). The carcinogenicity of this pollutant is of concern not only for~     the one million workers who are exposed occupationally, but also for the general population.~     Over 30 epidemiologic studies of diesel exhaust exposure have been performed, and the results~     suggest an increase in lung cancer risk. However, the association is not well defined. Past~     studies have suffered from the use of crude indicators of exposure, inadequate control of~     confounding, and/or short follow-up periods, low exposure levels, and small numbers of~     observations.~      NCI and NIOSH are collaborating on two related studies of diesel exhaust under the NCI/NIOSH~     Interagency Agreement. First, a retrospective cohort mortality study of about 8,200 non-metal~     miners will be performed to investigate lung cancer mortality in relation to quantitative~     measures of diesel exhaust exposure, and to determine whether there is evidence of elevated~     mortality from other causes of death among diesel exhaust exposed miners. The retrospective~     cohort study will be performed using existing records and information and has been exempted~     from IRB review. NIOSH is the lead agency on the retrospective cohort study.~      The proposed study is a case-control study nested in the retrospective cohort of non-metal~     miners. The study is expected to include at least 160 members of the cohort who died from~     lung cancer and four matched controls for each case. Using a structured questionnaire,~     detailed information will be collected on each subject's lifetime exposure to diesel exhaust,~     as well as information on smoking and other confounders. This information will allow~     investigators to examine the association between lung cancer and different quantitative~     measures of diesel exhaust exposure, adjusted for smoking and other potential confounders.~   "
245349|NCT00342251|"~     Age-related macular degeneration (ARMD) affects older Americans and can lead to irreversible~     blindness. Although the cause if ARMD is unclear, it appears to be a condition that is~     affected by both genetic and environmental influences.~      The purpose of this study is to examine an Amish community to investigate genetic factors in~     the development of ARMD.~      Study participants will be 1,000 members, ages 50 and older, of the Old Order Amish community~     in Lancaster and Franklin counties in Pennsylvania. Each will undergo a 30-minute dilated eye~     exam during which an ophthalmologist or optometrist will take digital images of the macula~     and optic disc. Depending on the results of their eye exam, participants may be asked to give~     a blood sample as well. They will also complete a brief questionnaire about personal exposure~     related to occupation, sunlight and smoking.~   "
245350|NCT00342225|"~     This study will examine changes in mother-child relationships when mothers are pregnant,~     because this period may involve conflicts between mothers and children. A widely held~     evolutionary theory postulates that because parents and offspring share only about 50 percent~     of their genes, conflicts occur and would most likely occur at times when parental investment~     decreases. Offspring benefit from obtaining maximal parental investment and may demand more~     investment than parents are willing to give at times, perhaps because the parent would better~     benefit from directing their energy to other pursuits, such as to other offspring or to work.~     This study will explore the following:~        -  How pregnant mothers treat their children, in terms of caregiving techniques;~        -  Whether mothers exhibit different caregiving patterns at different stages of pregnancy;~        -  Whether mother-child conflicts arise during pregnancy, and, if so, when during pregnancy~          they are most likely to occur; and;~        -  Whether offspring overtly resist changes in maternal behavior during pregnancy, and, if~          so, what behaviors children use to resist these changes.~      All pregnant Bofi forager women living in settlements near the villages of Ngotto, Poutem,~     Bambondji, and Grima (in the Central African Republic) who have one or more living offspring~     and have no serious health problems related to pregnancy may be eligible for this study. Bofi~     foragers are among the few remaining hunters and gatherers and, as such, offer an opportunity~     to examine child developmental theories that have been well studied among industrialized~     Euro-American cultures, but neglected cross-culturally. Furthermore, studies among~     contemporary hunter-gatherers provide insight into the evolutionary past of humans, as humans~     have lived as hunter-gatherers for about 99 percent of prehistory.~      Participating pregnant Bofi forager women will be interviewed for demographic information,~     family genealogy, fertility history, and parenting beliefs. The women and their children will~     be observed for 4 hours on two different days as they carry out their normal daily~     activities. Attention will be paid to the mother's investment in terms of direct care of the~     children, including behaviors such as holding, cleaning, comforting, grooming, and feeding~     children.~   "
245351|NCT00342212|"~     Background:~        -  Good measures of physical activity are needed for studies correlating physical activity~          and the risk of developing certain diseases.~        -  In preparation for use in a study of diseases and risk factors in Hispanic populations,~          NCI is evaluating a new model accelerometer to measure physical activity. An~          accelerometer is a small device worn on a belt at the waist that measures and records~          movement, capturing movement intensity and duration and associating it with clock-time.~        -  The new accelerometer (ActiGraph GTIM) uses a different type of motion detector from~          that used in the previous model (ActiGraph 7164).~      Objective: To evaluate and compare the ActiGraph GTIM with the ActiGraph 7164 by collecting~     physical activity data using both models.~      Eligibility: Men and women 18-74 years of age.~      Design: Study participants wear both model accelerometers while they walk or jog around a~     track at several self-selected paces. Data from the two devices are compared.~   "
245352|NCT00342199|"~     Information from this study is needed to plan an eventual trial of a GAS vaccine in India if~     and when one is available. A GAS vaccine is currently a priority of the Indian Council for~     Medical Research (ICMR), and this project has been approved by the Joint Working Group (US~     and Indian Delegates) of the Vaccine Action Program, a joint effort of the ICMR and NIAID to~     implement cooperative efforts between the two countries on mutual objectives in vaccine~     development. Currently, several GAS vaccines are in development, supported by NIAID, and~     other sources, and one candidate is in phase one clinical trial authorized by the FDA.~     Information on the antigenic structure of GAS isolated in India will be needed for planning~     vaccine composition. It is the view of the Indian Ministry of Health and Indian Council for~     Medical Research that eventual prevention and control of rheumatic fever and rheumatic heart~     disease in India, now a heavy burden on the children will require a GAS vaccine, which~     requires both access to primary health care and a vaccine if and when it is available.~      Information on incidence is needed to determine the size of a future vaccine cohort in order~     to obtain a statistically significant result on vaccine efficacy. Although unrelated to~     vaccine development, information on the incidence of GAS pharyngitis is needed in India to~     implement primary and secondary acute rheumatic fever (ARF) and rheumatic heart disease (RHD)~     prevention programs as were implemented in the USA and Europe forty years ago.~      A vaccine trial is not part of this study, nor is there any intervention, other than~     antibiotic treatment of all children volunteers who develop GAS pharyngitis or impetigo.~      An additional point should be made about the importance of obtaining epidemiological data on~     streptococcal disease in India, and on the emm types of GAS that cause infections. The~     population of India is over one billion people, representing nearly twenty five percent of~     the world's population. Information on GAS epidemiology from India is scant to say the least,~     and it is sorely needed. We now know that streptococcal toxic shock syndrome and fasciitis~     that have occurred in the U. S., Europe, Australia, and Japan, with greater frequency in~     recent years are caused by several genetically similar emm types of GAS. The implication of~     such genetic and epidemiologic data is that these genetically related strains have spread~     worldwide, Current information from India is far too limited to know if these virulent~     strains of GAS occur in India, and if they do, to what extent might they be the cause of~     frequent invasive disease in hospitalized patients.~      Equally important, we do not know if a potentially high virulent GAS strain is currently~     emerging in some locale(s) in India, and what possible threat it might become, if it were to~     be transported to other worldwide geographic regions. Although not a specific aim of this~     proposal, the surveillance conducted to accomplish the aims of this protocol will provide~     essential information on the possible emergence of an unexpected emm type with pathogenic~     potential.~   "
245697|NCT00337545|"~     Single center open-label study of an oral agent (RAD001) in subjects with metastatic~     colorectal cancer refractory to at least 2 standard chemo/biologic regimens.~   "
245353|NCT00342186|"~     This study, conducted by the Beijing University First Hospital of China and the National~     Cancer (NCI), will try to identify genes associated with either susceptibility or resistance~     to chronic infection by the hepatitis B virus (HBV). Some people recover from HBV infection;~     others become chronically infected and may go on to develop severe liver disease such as~     cirrhosis or liver cancer. About 350 million people worldwide have chronic HBV infection. Of~     120 million infected Chinese, 90 percent of children infected at less than 5 years of age and~     10 percent of infected adults develop persistent infection.~      HBV-infected and non-infected healthy persons of Han ethnicity born before 1963 may be~     eligible for this study. Offspring of infected candidates (born in any year) may also be~     enrolled. Infected adults must have at least one infected parent or sibling. Persons who~     resided in Fusui County of Guangxi Zhuang Autonomous Region or in the Qidong district of~     Jiangsu Province for at least 6 months before 1986 may not participate.~      All participants (except offspring of the study subjects) will fill out a health~     questionnaire (providing information about eating, drinking, and smoking habits and a~     personal and family health history) and will donate no more than 20 milliliters of blood. The~     blood will be tested for antibodies, antigens, and other substances that may indicate~     infection with hepatitis viruses. Some of the blood will be sent to the NCI for DNA analysis~     to identify genetic factors that may influence clearance of the hepatitis virus after~     infection or progression to liver diseases associated with HBV infection. Infected patients~     who have had a liver biopsy in the past will be asked permission to examine tissue from the~     biopsy and to review laboratory results of any tests done for diagnostic and treatment~     purposes.~      When the study is completed, specimens sent to the NCI will have identifiers linking the~     material to the donor removed. The anonymous samples may then be used for other genetic~     studies. Specimens remaining in China will continue to have identifiers linked to them and~     may be used for future studies designed to identify who is at greatest risk of developing~     serious liver diseases. Participants who do not want their blood used for future studies may~     request that the samples be destroyed.~      Because children inherit one-half of their DNA from each parent, DNA samples from HBV~     infected study participants may provide additional information about the parent s DNA~     structure. Offspring who participate in this study will provide a DNA sample. The sample is~     obtained by swishing a mouthwash in the mouth for 30 seconds and then spitting the mouth wash~     into a cup. The DNA is then isolated from the mouth cells.~   "
245354|NCT00342173|"~     A population-based study was initiated in Costa Rica in June 1993 to investigate the natural~     history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months,~     ending in December 1994, 10,080 women were recruited into our study, after informed consent~     was obtained. At the initial recruitment visit, all women were administered a brief risk~     factor questionnaire, had 15ml of blood collected and, if sexually active, were given a~     pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were~     additional cervical cells which were then used for additional monolayer smears (ThinPrep) and~     for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were~     also taken as a third screening test. Based on these screening tests, women were referred to~     colposcopy, at which time a more detailed risk factor questionnaire was administered,~     additional cervical cells and blood (15ml) were collected, and histological specimens were~     obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion~     (HSIL) or cervical cancer were treated by Social Security Administration clinicians using~     standard local protocols.~      Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who~     have been followed as part of our longitudinal study. Three distinct groups of women of~     approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The~     first group consists of women who at enrollment had evidence of low-grade cervical lesions~     (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group is being~     followed actively at 6-12 month intervals through their seventh anniversary in the cohort.~     The second group consists of women who were cytologically normal at enrollment but randomly~     selected for active follow-up. This second group will be seen once after enrollment, at their~     fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth~     anniversary visit will be added to the first group described above and followed at 6-month~     intervals. The final group consists of the remaining women in our cohort (all cytologically~     normal at enrollment). These women are being followed passively via linkage to the cytology~     and tumor registries in Cost Rica.~      Clinical visits conducted during follow-up consist of a brief personal interview that~     collects information on exposures since enrollment, the collection of 15ml blood, and a~     pelvic examination. Pap smear is prepared during the pelvic examination, and additional~     cervical specimens are collected and used to prepare a monolayer smear (ThinPrep) and for~     human papillomavirus and other testing. Similar to the enrollment visit, cervigrams are also~     collected from each participant at the time of their follow-up visits.~      During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear,~     ThinPrep, cervicography, or by visual inspection) are referred to colposcopy, censored from~     the study, and treated by Social Security Administration clinicians using standard local~     protocols.~   "
245355|NCT00342160|"~     This study will look at viral and immunologic factors involved in protecting against sexually~     transmitted HIV infection in couples in which one partner is infected and the other is not.~      This study will include 50 couples who reside in Rakai, Uganda, and who have been together~     for at least 2 years. In some couples, both partners will be HIV-infected, in some couples~     only one partner will have HIV, and in some couples neither partner will have HIV.~      Participants undergo the following procedures at each of four study visits:~        -  HIV counseling and testing~        -  Medical history, including questions about personal behaviors such as sexual practices~          and use of condoms~        -  Blood sample collection~        -  Urine sample collection~        -  Vaginal swab for women~      Blood, urine and vaginal fluid samples are tested for HIV and other sexually transmitted~     diseases, such as syphilis. Blood and vaginal samples are also tested for HIV viral levels~     and immune response in HIV-infected individuals and for evidence of exposure to HIV in~     non-infected participants. Some blood is also tested for genetic markers to investigate~     whether certain proteins are related to resistance to HIV infection.~   "
245356|NCT00342147|"~     Nasopharyngeal carcinoma is a rare tumor among Caucasians which occurs with high incidence~     among individuals of Chinese descent. The disease is believed to have a multifactorial~     etiology with genetic, viral, and other environmental factors being involved. Little is~     known, however, about the genetic component of this disease.~      We have recently completed subject recruitment for a case-control study of NPC in Taiwan.~     Using information obtained from the NPC cases recruited into this NCI-sponsored case-control~     study as well as from a parallel cross-sectional study conducted by our Taiwanese~     collaborators, we have been able to identify 120-150 families with multiple family members~     affected with NPC.~      The purpose of the study described herein is to determine the role of inherited genetic~     factors in the etiology of NPC and to examine the effect of these genetic susceptibility~     factors on risk associated with environmental exposures.~      Families will initially be contacted via the proband who previously participated in our~     case-control and cross-sectional studies. Subsequently, informative family members will be~     asked to visit the study clinic to participate in the study. A family history questionnaire~     will be administered to the proband from each of the families selected for study. In~     addition, a risk factor questionnaire will be administered to all participating family~     members, and 30-40 ml of blood and an oral sample will be obtained from each study~     participant. Additional study components include medical record review to verify the~     diagnosis of NPC, retrieval of tumor tissue blocks as a source of DNA for study, and clinical~     exams on a sample of unaffected individuals to exclude the possibility of prevalent,~     undetected disease among family members.~      Oral and laryngeal cancer families will also be recruited in a manner similar to that~     described for NPC families, in an attempt to elucidate genetic factors linked to the~     development of these two cancers.~   "
245357|NCT00342134|"~     Our goal is the elucidation of the mechanisms of action of autologous hematopoietic stem cell~     transplant (HSCT) and immunoablation by high-dose cyclophosphamide in multiple sclerosis~     (MS).~      The molecular pathogenesis of multiple sclerosis is poorly understood although T-cell~     mediated immune destruction of myelin is thought to be an important element. We hypothesize,~     and the results of previous studies suggest, that radical immuno-ablation characterized by a~     profound T cell depletion can arrest the progression of disease. Patients with MS with poor~     prognosis based on the rate of progression and refractoriness to approved treatments~     (interferon-beta, glatiramer acetate) will be enrolled in clinical trials at the~     collaborating institution (NWU-Dr. R. Burt; Dr. D Kerr, JHU) and will receive either immune~     ablation with cyclophosphamide and the antibody Campath-1 followed by reconstitution with~     autologous peripheral blood stem cells, a procedure similar to autologous bone marrow~     transplantation, or high-dose cyclophosphamide treatment without stem cell rescue. While the~     overall treatment-related mortality worldwide is approximately 10%, the collaborating~     institution and investigators have an outstanding safety record in performing the procedure~     with no fatal adverse events after having transplanted more than 30 transplants with a~     previously more aggressive regimen than the one that is in use now. The underlying rationale~     for this treatment is that immuno-ablation could eliminate myelin-reactive T cells which, in~     disease-susceptible individuals, may have been activated by previous exposure to~     environmental agents or other acquired mechanisms of immune dysregulation.~      In the proposed study we plan to address whether HSCT or immunoablation without stem cell~     rescue act beneficially in MS via the eradication of myelin-reactive T cells and~     reconstitution of a functional and non-autoimmune immune repertoire. To achieve this goal, we~     will compare peripheral blood T cell reactivities to myelin antigens before and after the~     treatment in 34 patients with MS. In parallel, to identify potential disease-mediating cells~     that do not recognize these myelin antigens, we will search for clonally expanded cells in~     the blood of MS patients before treatment employing molecular analysis of T cell receptor~     repertoire. Expanded T cell clones will be tracked during post-transplant follow-up of~     patients. If the eradication of certain clonotypes resulting from immuno-ablation correlates~     with disease remission, we will attempt to isolate these cells in culture from pre-treatment~     samples and determine their specificity using combinatorial peptide libraries. We would use~     the same approach in case of reappearance or new clonal expansions concomitant to disease~     relapses. We will combine these studies with a broader, unbiased approach that employs~     microarray technology to identify potential changes in gene expression profiles. This~     approach may also lead to the identification of novel therapeutic targets for pharmacological~     treatment.~   "
245378|NCT00341835|"~     This study will search for genes that greatly increase the risk of developing lung cancer in~     conjunction with cigarette smoking or other environmental agents, or both. Lung cancer is the~     second most common cancer diagnosed among men and women and the leading cause of cancer death~     in the United States. It has been frequently given as an example of cancer determined only by~     the environment, certain occupations, and dietary habits. Yet researchers have long had a~     hypothesis that people vary in their risk of becoming affected when exposed to these factors.~     Also, some evidence has shown that lung cancer in families may be due to the combined effects~     of inheritance of a major gene and cigarette smoking.~      Individuals who have a confirmed diagnosis of lung cancer or a family history of lung cancer~     may be eligible to enroll their families in the study.~      Family members will be asked to do one or more of the following:~        -  Complete a questionnaire about personal medical history, lifestyle, and diet.~        -  Have blood drawn from a vein in the arm.~        -  If a family member has had a biopsy or is scheduled for one, give permission to obtain~          medical records and a portion of the stored tissue.~        -  If any relatives have died of cancer, sign a release form to allow researchers to get~          copies of medical and pathology records, and tissue samples from surgery.~      If the family members agree, they may be recontacted to answer questions about their health~     and those of their family, during an annual telephone conversation. Follow-up questionnaires~     may be sent to participants, to determine if any new cancers have developed in the family. In~     the event of a new cancer, the classification of the family may change from the low-risk to~     intermediate risk-level and from the intermediate-risk to high-risk level. Follow-up will~     continue, to get information about tumors and death. Also, a newsletter for lung cancer~     families will occasionally be distributed to participants. In the future, the Internet will~     also provide information for families.~   "
245358|NCT00342121|"~     This study will look for links between corn farming practices and short-term changes in~     immune function in farmers throughout the growing season. It will examine biologic effects~     associated with specific pesticide exposures and general planting activities, such as~     tillage. Farmers have an increased risk of non-Hodgkin s lymphoma and certain other blood~     cancers such as multiple myeloma and leukemia, but the reasons for this increase have not~     been identified. Findings of this study may contribute to learning the causes of cancers such~     as non-Hodgkin s lymphoma.~      Farmers enrolled in the Agricultural Health Study (a study of pesticide applicators and their~     spouses in Iowa and North Carolina) and a group of control subjects selected from~     agricultural extension workers in Iowa may participate in this study.~      The study involves six home visits to farmers and four visits to farmers to individuals in~     the control group. All participants will complete the following tests and procedures:~        -  Questionnaires and diaries During the first visit, all participants will have a medical~          history review, including questions about smoking and other health habits. Farmers will~          be asked about their farming practices, and controls will be asked about their~          occupations. Farmers will fill out daily diaries during short time periods of interest~          around certain pesticide applications to describe farming activities that day. At other~          times during the growing season before harvest, farmers will fill out weekly diaries~          describing farming activities; controls, meanwhile, will fill out weekly diaries~          describing their health and work activities. At home visits during the farmers growing~          season, all participants will fill out questionnaires about their health. Finally,~          farmers and controls will complete a more extensive questionnaire in the off-season,~          during the last home visit, to learn about their activities and exposures in the final~          part of the year (post-harvest for farmers).~        -  Urine samples: At the time of each home visit, controls will provide a urine sample that~          the interviewer will take that day. Farmers, too, will provide urine samples at the time~          of home visits, but they will also collect urine samples for a period of 4 days each~          during short time periods of interest after certain pesticide applications. The~          interviewer will collect these samples immediately at the end of these periods.~        -  Blood samples: At the time of each home visit, the interviewer will draw 50 ml (3.5~          tablespoons) of blood.~        -  Telephone calls: Farmers will be called frequently from once every 2 weeks to every~          other day to schedule visits at the times of interest. Control subjects will also be~          called frequently to schedule their visits closely to those of the farmers.~   "
245359|NCT00342108|"~     This study will investigate the effect of enhanced visual and cross-modal environments upon~     the visual attentiveness of multiply handicapped children diagnosed with Cerebral Palsy (CP)~     and Cortical Visual Impairment (CVI).~      Research Hypothesis~        1. Adapted visual environments which present controlled auditory, tactile, proprioceptive~          or contrasting visual background stimulation will enhance the visual attentiveness to a~          given visual stimulus of children diagnosed with CP and CVI.~        2. Systematic, repetitive, visual stimulation over time, improves the visual attentiveness~          and/or visual-motor responses of CP-CVI children.~        3. The analysis of additional behavioral responses to visual stimuli is a critical~          component in evaluating the perceptual development of visual attention in CP-CVI~          children.~      Use of Noldus: The Observer, an advanced objective computerized observation program, will~     enable precise detection of the neurobehavioral responses of the participants. Both overt and~     covert responses will be observed, analyzed and correlated to identify the level of attention~     of each participant.~   "
245360|NCT00342095|"~     Systemic lupus erythematosus (SLE) is severe, chronic, disabling autoimmune disease that~     significantly affects health status and quality of life. Since the disease occurs most often~     in young to middle-aged adults, SLE can also affect work and disability. However, there is~     currently little information on work-related disability from longitudinal, population-based~     studies of SLE.~      Participants were enrolled into the Carolina Lupus Study between February, 1997 and July~     1999. We plan to conduct two telephone contacts with patients and one telephone contact with~     controls in a follow-up study to be conducted in 2001. The first patient contact will follow~     an introductory letter that describes the follow-up study. This letter provides participants~     the opportunity (via a toll-free phone number) to decline further contact about this study.~     The first patient contact will be a short (5 minute) interview in which we determine their~     current source of lupus-related medical care, timing of next expected visit, and update~     contact information. The second contact will involve a 60-minute telephone interview covering~     medical care utilization, current health status (including a patient-administered measure of~     lupus activity), work and disability issues, psychosocial attributes (e.g. helplessness,~     social support, daily stressors including race-related issues), and changes in exposures~     since the initial interview. We will attempt to schedule the patients' interviews within 3~     months before or after the patient sees his or her own physician for SLE-related evaluation~     or treatment. A short (15 minutes or less) telephone interview will be conducted with~     controls focusing on current health, work status, and daily stresso.~      Ddisease damage will be assessed using the System Lupus international Collaborating Clinics~     (SLICC)/American College of Rheumatology (ACR) Damage Index, a standardized and validated~     instrument that is completed by the patient's physician.~      We will seek death certificates for patients and controls who have died in order to obtain~     cause of death information. Next-of-kin information from death certificates will not be used.~      This study will allow up to determine the feasibility of obtaining reliable data on disease~     damage from more than 50 physicians involved in the treatment of patients in the Carolina~     Lupus Study. This developmental work is a necessary foundation for any additional follow-up~     studies of the Carolina Lupus Study cohort. We will also be able to examine associations with~     disability in patients and in controls and to examine the contribution of various factors to~     the increased disease severity experience by African-American SLE patients.~   "
245361|NCT00342082|"~     This collaborative investigation between NIEHS, Duke University, and the University of North~     Carolina (UNC) will study red blood cells of babies born to HIV-infected women receiving~     anti-retroviral treatment. Studies have shown that newborn mice whose mothers were given~     anti-HIV medications during pregnancy had abnormal red blood cells circulating in their blood~     stream, indicating genetic damage to the cells caused by the anti-HIV medications. It is not~     known if similar red blood cell abnormalities develop in human infants whose mothers received~     anti-HIV medication during their pregnancy. This study will examine red blood cells from~     infants exposed to anti-HIV medications and from non-exposed infants to look for differences~     between them involving this specific genetic damage.~      Healthy pregnant women and HIV-infected pregnant women who received antiretroviral treatment~     during their last trimester of pregnancy and during labor may be eligible for this study.~     Babies of HIV-infected women are also included in the study. Candidates will be recruited~     from medical centers at Duke University and the UNC. HIV-infected mothers must plan to have~     their baby followed by either the UNC or the Duke Pediatric Infectious Disease clinic.~      All women in the study will have 1 milliliter (less than 1/2 teaspoon) of blood collected for~     this study during delivery at the same time that other blood samples are obtained for their~     medical care. In addition, 5 ml (1 teaspoon) of umbilical cord blood will also be collected~     for this study at the time of delivery after the cord is no longer attached to the baby. This~     concludes participation of non-HIV infected women.~      Babies born to HIV-infected mothers will have 1 ml of blood drawn between 0 to 3 days of~     life, between 4 to 6 weeks of life, and between 4 to 6 months of life. These bloodsamples~     will be collected at the same time as other routine scheduled blood draws.~   "
245362|NCT00342069|"~     This study will examine how women think and feel about prenatal testing (amniocentesis and~     chorionic villus sampling), how those thoughts and feelings change over time, and how they~     contribute to the decision whether or not to undergo prenatal testing.~      Prenatal diagnostic testing is offered to pregnant women at increased risk of carrying a baby~     affected with a genetic or chromosomal abnormality. Although these tests are well~     established, standard-of-care procedures, much remains unknown about how best to ensure that~     women make decisions about whether or not to undergo testing that are consistent with their~     beliefs and values. This study will explore the extent to which women are ambivalent about~     prenatal testing and determine how they might benefit from counseling aimed at improving the~     quality of their decision-making.~      Women 18 years of age and older who are scheduled for a prenatal genetics visit at clinics in~     Baltimore, MD; Minneapolis, MN; Binghamton, NY; Salt Lake City, UT; Washington, DC; and~     Bellevue, WA, and are at increased risk for having a baby with trisomy 21 (Down syndrome) may~     be eligible for this study.~      Participants complete two short questionnaires and a telephone interview about their thoughts~     and feelings regarding prenatal testing. The first two surveys examine the women's thoughts~     and feelings before and after prenatal counseling. Both are completed at the prenatal~     clinic-one before and one after the counseling session. The third survey is done by telephone~     a few weeks after the prenatal visit to find out if the participant did or did not have~     prenatal testing and learn about her thoughts and feelings regarding her decision.~   "
245364|NCT00342043|"~     This study, sponsored by the National Institutes of Health and the University of Bamako in~     Mali, Africa, will examine factors that may protect against progression of malaria from mild~     to severe disease. Infection with the malaria parasite causes disease ranging in severity~     from mild or no symptoms to severe. A better understanding of what factors protect against~     disease progression may help scientists develop improved methods of disease prevention and~     treatment. The objectives of this study are to:~        -  Identify differences in protective factors for severe malaria in Malinke children~          residing in two Mali villages, Kela and Kangaba. Genetic variations in hemoglobin~          proteins called HbS and HbC appear to confer protection against severe disease in some~          children but not others. HbC appears to protect young Malinke children living in Kela,~          but not in nearby Kangaba, while HbS protects children in Kangaba but not in Kela. In~          addition, deficiency of an enzyme produced by red blood cells called G6PD protects~          males, but not females, from severe malaria.~        -  Investigate how fetal hemoglobin (HbF) may protect against malaria in infants and~          determine how HbS, HbC, G6PD deficiency, and beta-thalassemia trait affect the rate of~          HbF decline during the first 2 years of life.~      Children under 11 years of age who seek medical care at Kangaba or Kela health centers for~     symptoms of malaria may be eligible for this study. Each will be screened with a medical~     history, physical examination and blood test. In addition, healthy infants born to women~     referred to field site clinics may be enrolled for the newborn study. Participants undergo~     the following procedures:~      Children with mild malaria are treated with artesunate and amodiaquine. Those with severe~     malaria are treated with quinine. Blood is collected by finger prick every day for 4 days to~     evaluate the response to treatment and for genetic testing. Some blood is stored for future~     research related to malaria.~      Newborns have a heel or finger prick at 1, 3 and 6 months to collect a small blood sample for~     genetic testing. In addition, at the time of birth, a small amount of blood is collected from~     one of the blood vessels of the placenta. Some infants may be followed up to 2 years, with~     additional drops of blood taken at 12, 18 and 24 months. Some of the blood is stored for~     future research related to malaria.~   "
245365|NCT00342030|"~     There is suggestive evidence for a role of dietary in the etiology of asthma and chronic~     bronchitis. However, there are few prospective data. We propose to expand our collaboration~     with the Singapore Chinese Health Study to examine dietary, environmental, and genetic~     factors, along with their interactions, in relation to the risk of developing asthma and~     chronic bronchitis. The Singapore Chinese Health Study is a cohort of 63,257 men and women of~     Chinese ethnicity in Singapore who were aged 45-74 years at enrollment from 1993 to 1998.~     Telephone follow-up of the cohort to update and outcome information began in 1999 and is~     ongoing. We expect to identify 538 cases of incident asthma and 672 cases of incident chronic~     bronchitis when the current follow-up questionnaire cycle is complete in 2004. In this~     proposal, we would validate self-reports of incident asthma, obtain follow-up data from the~     entire cohort to perform analyses of dietary and smoking in relation to these outcomes, and~     analyze genetic material on cases of incident asthma and chronic bronchitis and controls from~     the cohort. In this proposal we will examine the following hypotheses:~        1. Higher intake of fruits and/or antioxidant micronutrients decreases the risk of~          developing asthma and chronic bronchitis.~           a. Effects if fruit and/or antioxidant micronutrients may differ by smoking history.~        2. Common polymorphisms in genes involved in the response to oxidative stress influence the~          risk of asthma and chronic Bronchitis. We initially propose to examine polymorphisms in~          three genes--glutathione S-tranferase M1, glutahione S-transferase P1, and matrix~          metalloproteinase-1. However, we plan to examine additional relevant polymorphisms in~          the future, especially taking advantage of high throughput screens of candidate genes~          for asthma and chronic bronchitis. It is possible that by 2004 when the sample set will~          be available that more compelling candidates and high throughput screens may be~          available to us at a low cost. Thus we will re-evaluate our choice when the samples are~          available.~        3. Polymorphisms in these and other genes interact with fruit/antioxidant intake and/or~          smoking to influence the risk of asthma and chronic bronchitis.~   "
245366|NCT00342017|"~     This study, sponsored by the National Institutes of Health and the Tuberculosis Research~     Centre in Chennai, India, will examine how helminth and filarial infections affect the immune~     response to mycobacteria (the bacteria that causes tuberculosis). Helminths are parasitic~     worms that infect the gut, and filaria are worms that circulate in the blood and infect~     various tissues. The findings of this study may affect how tuberculosis is assessed in~     Chennai, where filarial and helminth infections are common in the population.~      Patients between 6 and 65 years of age with helminth or filarial infections who do not have~     active tuberculosis, cancer, AIDS, or other immunosuppressive illness may be eligible for~     this study. Participants will be recruited from villages in the Chingleput District of~     Chennai, India.~      Participants will complete a medical history and physical examination. They will have a blood~     test to determine red blood cell count and to detect filarial infection, a stool examination~     to detect helminth infection, and a tuberculin skin test for tuberculosis. Patients with a~     positive tuberculin test will be treated for tuberculosis and any filarial or helminth~     infections that may have been detected.~      Patients whose tuberculin test is negative will be invited to participate in the second part~     of the study-to determine whether people with either filarial infections or helminth~     infections, or both, respond to tuberculosis bacteria in the same way as people who do not~     have these infections. Participants will undergo a review of their medical history, a~     physical examination, and a blood test to assess red blood cell levels and to look for~     evidence of filarial or helminth infection. They will then be randomly assigned to receive~     either albendazole and DEC (anti-helminth and anti-filarial drugs) or a placebo (look-alike~     tablets that do not contain an active ingredient). Two months later, patients will receive a~     second dose of the same tablets (placebo or active drug) they took previously, and after~     another 4 weeks they will be re-tested for tuberculosis. After 6 months (at the end of the~     study) all participants will receive anti-helminth and anti-filarial drugs and will have a~     repeat tuberculin skin test. Blood and stool samples will be collected twice in the 6-month~     period after the initial treatment to determine the levels of antibody against the parasites,~     to measure the level of infection with filaria, and to measure the level of red blood cells.~   "
245367|NCT00342004|"~     A prospective cohort study is proposed to evaluate occupational and environmental risk~     factors for cancer among women in Shanghai, China. Approximately 75,000 women aged 40-69 who~     reside in eight geographically defined communities in two urban districts of Shanghai will be~     recruited via a community-based cancer education program. All eligible subjects will be~     invited by local health workers from the neighborhood health station to the clinic for an~     interview and selected anthropometric measurements. The interview will elicit information on~     demographic background, diet, lifestyle factors, medical history, lifetime occupational~     history and residential history for the past 20 years. In addition, the women will be asked~     for information on their husbands' current and usual occupations, and demographic and a few~     other exposure factors. A spot urine sample and 10 ml of blood will be collected from all~     cohort members and stored at -70 degrees C for future assays of urine metabolites and DNA and~     hemoglobin adducts of selected occupational and environmental carcinogens, and polymorphic~     genes encoding enzymes that are involved in metabolism of relevant carcinogens. Cohort~     members and their husbands will be followed for cancer outcomes through biennial recontact~     and linkage with files of the population-based Shanghai Cancer Registry, of the Shanghai~     Vital Statistics, and of the Shanghai Resident Registry. Medical records and pathology slides~     will be reviewed for all cancer cases to verify their diagnosis. Post-diagnostic blood~     samples will be obtained from all cohort members diagnosed with cancer during the follow-up~     period and stored for future methodologic and etiologic studies. The proposed initial study~     period is 5 years, with an average follow-up of about 3.5 years. We anticipate, however, that~     follow-up will continue for 10 years or more....~   "
245368|NCT00341991|"~     This case-control study was planned to investigate the link of solar radiation with gene~     damage, host factors, and DNA repair proficiency in cutaneous malignant melanoma (CMM) risk.~     The hypothesis was that impaired DNA repair proficiency is associated with an increased risk~     of CMM due to unrepaired DNA damage, particularly in subjects with dysplastic nevi, poor~     tanning ability or genetic susceptibility.~      The study was reviewed as an RO1 Grant from the National Cancer Institute in 1995. Subject~     enrollment, which included clinical evaluation, epidemiologic questionnaires, and skin and~     blood sample collection, was completed in 1999 on approximately 180 melanoma cases and 180~     controls identified in Italy. The study protocol and consent form both included the~     measurement of genetic and biochemical factors and DNA repair capacity. DNA repair~     proficiency was measured in lymphocytes by the host cell reactivation assay, and sun exposure~     was evaluated by means of a detailed questionaire. Photographs of the back of the subjects~     were taken to allow nevi count. Minimal erythemal dosage was measured in all subjects to~     estimate skin sun sensitivity 24 hours after skin's UV-irradiation. Skin color was~     ascertained on the inner side of the forearm by means of a Minolta chromometer.~      The aim of this protocol is to continue analysis of the biological samples already collected,~     as originally outlined in the study protocol. In particular, we plan to measure polymorphisms~     in genes that may lead to susceptibility to melanoma. Initially we will concentrate on~     variation in genes involved in repairing damaged DNA, but plan to look at a broad group of~     candidate susceptibility genes.~   "
245698|NCT00337532|"~     The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination~     regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer.~     the safety of this treatment will also be studied.~   "
245369|NCT00341965|"~     We propose to conduct a study to increase our understanding of farming practices and of the~     potential for previous exposure to DDT in North Carolina African American male agricultural~     workers, a group especially likely to have had high DDT exposure. Because of potentially~     widespread DDT exposure from agricultural activities, African American farmers and farm~     workers may be uniquely at risk for any associated health effects. However, little is known~     about levels of pesticide exposure in African American farming populations. Three hundred and~     eighty-nine African American men who are current or former farmers or farm workers will be~     asked to participate in the study. These men are members of the Supplemental Minority Cohort~     of the NCI/NIEHS/EPA Agricultural Health Study (AHS). The AHS is a prospective study of the~     potential health effects associated with agricultural exposures. Men in the supplemental~     cohort were recruited in 1996. At that time, they completed an enrollment questionnaire that~     focused on lifetime agricultural exposures, demographics, lifestyle factors and health. In~     this new study, a follow-up questionnaire will be administered by telephone by a trained~     interviewer to all men. Following the interview, the participant will be asked to donate a~     blood specimen, to have anthropometric indices (e.g., height, weight, waist and hip~     circumference, etc.) measured, and to have a top- and side view Polaroid photograph of their~     head taken during one visit to a central community location, such as the local church or~     health clinic. We will quantitatively document serum p,p'-DDE levels, correlate these with~     self-reported farming activities and DDT exposure, and describe the health status of these~     men. We will also correlate serum p,p'-DDE levels and androgen concentrations, since p,p'-DDE~     is thought to be a potent androgen receptor antagonist. This exploration of the potential~     link between levels is important because the demonstration of any subclinical physiological~     effects of p,p'-DDE would increase the plausibility of a wide range of health effects that~     have been postulated to be associated with the endogenous endocrine environment and the~     so-called endocrine disrupters. In addition, we will evaluate the relationship between~     several important physiological parameters which can be easily and accurately measured in~     serum, and physical characteristics including hair patterning and distribution of body fat in~     these African American men.~   "
245370|NCT00341952|"~     Non-Hodgkin's lymphoma (NHL) incidence rates have risen three percent per year in the U.S.~     for four decades. Mortality from NHL has risen 1.6 percent, compared with 0.2 percent for all~     cancers combined. This epidemic curve appears in both sexes and around the world, suggesting~     the possibility of an etiologic agent increasing in prevalence in the general environment.~     Recent research has identified several possible candidates including pesticides, other~     organochlorines, drinking water nitrates, and sunlight. There is an urgent need to evaluate~     whether these common exposures are contributing to the rapid rise in NHL, and to investigate~     other hypothesized risk factors such as viruses, medical conditions, hair dye use, and~     genetic factors. The purpose of this study is to examine the contribution to NHL risk of~     these important environmental, occupational, viral, medical, and personal exposures, and to~     pursue important leads emerging from on-going NHL research. This multidisciplinary,~     population-based case-control study will involve personal interviews to collect information~     on demographics, residential history, pesticide use, and occupational exposures;~     self-administered questionnaires to collect information on diet, family and medical history,~     and other exposures; tap water and carpet dust sampling to collect information on nitrate and~     pesticide exposures; and blood sampling for measurements of compounds in the serum,~     antibodies to viruses, and examination of genetic polymorphisms.~   "
245371|NCT00341939|"~     This study is a retrospective one, exploring the hypothesis that a person's genotypic makeup~     may be associated with a clinical response or toxic effect to a drug. Genetic polymorphisms,~     that is, states of being able to assume different forms, that are in drug-metabolizing~     enzymes, transporters, and receptors may affect a patient's response to drug therapy. To~     date, there have been limited studies looking at a drug-metabolizing genotype (genetic~     makeup) or phenotype (result of the genotype's interaction with the environment). However, it~     is often wondered if the variations in a drug's action, that is, pharmacokinetic effect, come~     from the genotype phenotype relationship.~      Participants who entered previous clinical trials at the National Cancer Institute, as~     approved by the Central Institutional Review Board, may be eligible for this study. Studies~     for which pharmacokinetic analyses were or are being performed will be the source of the~     patient population.~      Genotyping experiments will be performed through genomic DNA isolated from stored frozen~     serum. The genotyping results will be compared with pharmacokinetic data and clinical~     outcomes. Clinical data will consist of what is obtained during the course of the principal~     pharmacokinetic study. The results of the retrospective analyses will provide no direct~     benefit to the participants.~   "
245372|NCT00341913|"~     Reduced susceptibility of Staphyloccus aureus to the glycopeptide antibiotic vancomycin is~     causing increasing concern worldwide in view of the threat of increased morbidity and~     mortality caused by such resistant organisms. MRL Pharmaceutical Services, a Division of~     Focus/MRL, has been contracted by NIAID to establish a Network on Antimicrobial Resistance in~     S. aureus (NARSA) to document cases where staphylococcal isolates with reduced susceptibility~     to vancomycin (MIC's greater than or equal to 4 micrograms/ml) have arisen and to procure~     such isolates into a central repository for distribution to registered approved researchers.~      MRL will be responsible for contacting sites where such isolates have been reported to~     discuss the test methods used to determine the reduced vancomycin susceptibility status of~     the isolate. Once the MRL Laboratory has determined that the isolate meets the criteria~     stated above, the site will be asked to ship the isolate to MRL as a possible candidate for~     inclusion in the NARSA Repository. The procurement strategy will involve issuing each isolate~     a temporary strain designation number which will be destroyed once the antibiotic profile of~     the isolate has been confirmed at MRL, thus preventing any link to the data generated by the~     site. The isolate and its antimicrobial susceptibility profile to several key drugs will be~     recorded in the NARSA Repository database. Demographic information related to the isolate and~     collected from the site includes: The Name of the Donor Site/Institution, City (to be held in~     a separate secured database, these data points are not available to registered user); State,~     Country of Donor Site; Isolation Date; Age; Sex; Patient Location; Patient Service; Culture~     Source; Reporting History. This information will be held in the Registry database. Since~     patient-specific information will not be collected, a request for a waiver of informed~     consent has been requested herein.~      NIAID funded investigators (NARSA Core Investigators) and other approved registered users~     whose research focuses on S. aureus will have access to the Registry/Repository database and~     will be able to request isolates for use in their research. Facility specific information~     will be held in a separate secured database that is not available to registered researchers~     unless approved through an IRB review.~   "
245388|NCT00341705|"~     The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively~     follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus~     (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have~     been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the~     rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to~     evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are~     likely to be on the causal pathway for these conditions. Candidate clinical and laboratory~     markers will be examined longitudinally to define changes over time and their relationships~     to one another. Collaborative studies will focus on genome scanning and evaluation of~     candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the~     diseases that result from these infections. Additional studies will identify response and~     complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive~     clinical care of persons with hemophilia.~   "
245716|NCT00337272|"~     This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the~     treatment of insomnia in patients that have completed their first chemotherapy treatment for~     breast cancer.~   "
245373|NCT00341900|"~     Ionizing radiation efficiently induces chromosomal aberrations (CA) and several studies of CA~     have now been conducted among small groups of flight crews. However, most of the studies only~     evaluated the unstable aberrations that reflect recent exposures, but not long-term~     cumulative cosmic radiation exposure. Chromosome painting by fluorescence in situ~     hybridization (FISH) is a widely used and established cytogenetic method for detecting stable~     aberrations such as translocations. Thus, FISH can be used for estimating chromosomal damage~     from cumulative radiation exposure. No large studies of flight crews utilizing FISH have been~     conducted to date.~      We propose a study to measure CA using FISH in a group of pilots estimated to have high comic~     radiation exposure based on flight histories, i.e., those with long duration flying~     international routes, and a comparison group of university faculty with minimal flying~     history. These measurements will be used to determine if pilots have elevated frequencies of~     CA (specifically stable translocations) as compared with the university faculty. In addition,~     the frequencies of CA will be examined in relation to the cumulative cosmic radiation dose to~     determine if there is a dose-response relationship. Individual cumulative doses will be~     calculated from pilot flight histories using a computer program developed by the FAA which~     estimates cosmic radiation does by accounting for changes in altitude and latitude, and the~     11-year solar cycle at the time of the flight. We will collect information on age, lifestyle~     factors, diet, health history, family cancer history, and medical radiation exposures from~     personal interview and self-administered dietary questionaire. These factors may affect the~     CA frequency and so we plan to adjust for them in the statistical analyses.~      Pilots will be identified based on the Allied Pilots Association roster and faculty from a~     commercial company that maintains a database of university faculty, including those in the~     Chicago area. Potential participants will be notified of the study by mail and~     recruited/screened for eligibility over the telephone. We will compensate participants $100~     for their time. A field station will be set up at a medical or health clinic convenient to~     the participants, where interviews Will be conducted and a peripheral blood sample collected.~     Participants will be notified of the overall study results and may request their personal CA~     results at the end of the study. Participants may also choose to have additional blood drawn,~     however this blood sample will be anonymized so that it cannot be linked back to the~     participant. Genotypic variants in DNA repair (and possibly other) genes will be evaluated~     for an effect on CA frequency.~   "
245374|NCT00341887|"~     This project, called PHIDISA I, will screen uniformed personnel of the South African National~     Defense Force (SANDF) and their registered family members for HIV, hepatitis B and C,~     gonorrhea, syphilis, and chlamydia to determine the incidence and prevalence of these~     sexually transmitted diseases. It will identify people who may be eligible to participate in~     clinical trials for preventing or treating HIV disease and will provide information that will~     be helpful in developing policy and better care for people affected with HIV and other~     diseases.~      This project is part of the South Africa-U.S. PHIDISA Programme-a collaboration between the~     South African Military Health Service (SAMHS) of the SANDF, the U.S. Department of Defense,~     and the U.S. National Institutes of Health-to help prevent HIV transmission among South~     African military and civilian employees and their families.~      Uniformed SANDF personnel or their family members who are eligible for health services from~     the SAMHS may enroll in the study. Participants visit the clinic every 6 months for up to 5~     years for the following tests and procedures:~        -  Fill out a demographic information questionnaire~        -  Fill out a HIV risk assessment questionnaire~        -  Fill out a quality of life questionnaire~        -  Blood test~        -  Urine test~        -  Review of test results and counseling session with a doctor or nurse~      Patients who test positive for HIV have a physical examination and additional blood draws.~   "
245375|NCT00341874|"~     The incidence of hearing impairment in India and Pakistan is higher than in the United~     States. This can be attributed to several factors, including infection and high rate of~     inbreeding which may result in homozygosity for a rare recessive mutation. The average family~     size is larger in India and Pakistan when compared to the United States. In addition, there~     are more than 1 billion people in India while the population size of Pakistan is~     approximately 148 million. The ability to detect linkage is greatly enhanced in an extended~     inbred family. It is estimated that as many as 45% - 60% of marriages in Pakistan are between~     close relatives (the vast majority of marriages are to first cousins). While the percentage~     of consanguineous marriages are not as high in India as compared to Pakistan, the population~     size of India is much larger.~      Hearing impairment is the result of abnormal ear development, abnormal ear function or both~     and yet little is known about the molecular mechanisms involved in the development and~     homeostasis of the inner ear. Although the genes for several recessive deafness loci have~     been identified, there are still many families segregating deafness that cannot be ascribed~     to one of the currently known genes. The purpose of this study is to continue to identify~     genes that cause nonsyndromic hereditary hearing impairment by enrolling families segregating~     deafness.~   "
245376|NCT00341861|"~     The incidence rate of bladder cancer in the Barcelona area of Spain is almost identical to~     that of the U.S. Cigarette smoking has been identified as the most significant risk factor~     for bladder cancer, followed by occupational exposures to chemicals such as aromatic amines~     and their derivatives, diesel exhaust, oil mist, pesticides, and polynuclear aromatic~     hydrocarbons. A variety of non-occupational exposures have been suggested as potential risk~     factors as well, including smoking black vs. blond tobacco, dietary factors, certain~     medications and medical conditions, chlorination by-products in drinking water, and fluid~     intake. Various genetic polymorphisms also appear to affect bladder cancer risk. Research is~     needed to further explore hypotheses generated by previous etiologic studies of bladder~     cancer. An on-going study of bladder cancer survival by the Institut Municipal d'Investigacio~     Medica in Spain provides an excellent opportunity for NCI to perform such research. NCI will~     build upon the ongoing study by funding an interdisciplinary case-control component to~     evaluate bladder cancer risk in relation to various external factors (e.g., occupational and~     environmental exposure) and host factors (e.g., genetic susceptibility markers, and early~     effect markers). This hospital-based case-control study will involve personal interviews~     using a state-of-the-art, computer assisted technique, and collection of blood and toenail~     samples from participants.~   "
245377|NCT00341848|"~     Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for~     over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that~     parity has a protective association with leiomyoma, but the mechanism is not known. Both~     epidemiologic data and data from an animal model indicate that the protective association is~     not an artifact resulting from reduced fertility among women with fibroids. We hypothesize~     that the process of uterine regression following delivery results in loss of small fibroids~     due to selective apoptosis of transformed cells and the extensive remodeling of the entire~     uterus.~   "
245594|NCT00338923|"~     This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic~     neuropathic plantar and venous ulcers.~      HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration~     and differentiation at the wound area.~        -  The primary end point of this study is assessment of safety in treating with HO/03/03~          and the efficacy of the drug to promote wound closure of chronic wounds.~        -  The secondary end points are assessment time to closure and healing rate for the~          measurement of wound healing progression.~   "
245379|NCT00341822|"~     This study will explore the decision-making experiences of women who are currently pregnant~     following a period of infertility on whether or not to undergo an invasive prenatal test~     (IPT) procedure, such as amniocentesis or chorionic villus sampling. Women who become~     pregnant after infertility often experience heightened anxiety regarding the outcome of the~     pregnancy. When choosing whether or not to have IPT they are faced with a complex decision,~     set in the unique context of a pregnancy that they often perceive as exceptionally~     precarious.~      Women who are pregnant with their first child after a period of infertility and have made a~     decision regarding whether or not to undergo IPT may be eligible for this study.~      Participants complete an online password-protected questionnaire that measures infertility~     and decision-making variables and explores women's perceptions of the impact of infertility~     on their IPT decision-making process. The questionnaire covers the following areas:~        -  Subject's demographic information, such as age, marital status, number of children,~          education, race, ethnicity~        -  Subject's infertility history~        -  Subject's thoughts and feelings about infertility~        -  Subject's thoughts and concerns about other people's (e.g., husband, doctor, other~          infertile women) opinions about IPT~        -  Subject's decision about whether or not to have IPT and her feelings regarding the~          decision~        -  The effect of subject's infertility history on her decision to have or not have IPT~   "
245380|NCT00341809|"~     This study will examine the genetic basis of psoriasis and psoriatic arthritis. It is known~     that genes play an important role in determining who gets psoriasis or psoriatic arthritis.~     This study will look for specific gene variants (alleles) that run in families with these~     conditions, or are found more often in people with these conditions than in those without~     them.~      Participants for this study were identified through the dermatology services of the~     University of Michigan Medical Center, the Ann Arbor Veterans Affairs Medical Center, the~     University of Kiel, and Henry Ford Hospital. Additional families were provided by the~     National Psoriasis Foundation Tissue Bank. They include people with psoriasis or psoriatic~     arthritis, or both, in addition to some family members of patients. Only families in which~     the age of the patient at disease onset was below 40 years are included. Patients were~     included if they had lesions covering more than 1 percent of their total body surface area or~     if at least two skin, scalp, nail, or joint lesions were diagnosed as psoriasis. Healthy~     volunteers are also enrolled as control subjects.~      Participants undergo the following procedures, as follows:~      Patients with psoriasis and people without psoriasis who have multiple family members with~     the disease~        -  Skin evaluation~        -  Photographs of lesions for documentation~      Patients with psoriatic arthritis and people without psoriatic arthritis who have multiple~     family members with the disease~        -  Joint evaluation and possibly ultrasound~        -  Joint X-rays or review of existing X-rays~      Patients with psoriasis only, with psoriatic arthritis, and healthy volunteers~        -  Blood draw of 30 milliliters. Some of the blood collected will be used to test for~          rheumatoid factor and C-reactive protein in patients with psoriatic arthritis.~        -  Periodic questionnaires to update health status information~   "
245381|NCT00341796|"~     This study, conducted in Tamil Nadu, India, was initiated in response to the developing~     epidemic of HIV/AIDS in India. It is divided into two stages, as follows:~      Stage I~      All women registered in the pregnancy clinics at the Namakkal District Hospital or the~     Rasipuram Government Hospital in the state of Tamil Nadu in India will be offered~     participation in an educational session on HIV infection and transmission. It will include a~     pre-educational assessment of knowledge, attitudes, and beliefs, and a post-educational~     assessment of knowledge about HIV infection and transmission. All women at the clinic,~     regardless of whether or not they participate in the educational and assessment sessions,~     will be offered HIV counseling and testing. The objectives of this stage of the study are to:~        -  Assess the acceptance of education about HIV infection and transmission among pregnant~          women at the participating sites and their knowledge, attitudes, and beliefs about HIV~        -  Assess the acceptance of voluntary counseling and HIV testing among pregnant women at~          these sites~        -  Determine the prevalence of infection among women who accept HIV testing at these sites~      Stage II~      Pregnant HIV-infected women at the pregnancy clinics at the Namakkal District Hospital or the~     Rasipuram Government Hospital who are 18 years of age or older will be offered enrollment in~     Stage II of this study. Participants will be followed during their pregnancy and until their~     baby is a year old. The baby will be a part of the study from birth to one year of age. After~     delivery, both the mother and baby will be followed with regularly scheduled visits that~     include a physical examination and blood test.~      Treatment with the anti-AIDS drug zidovudine will be offered for both the mother and child.~     For the study protocol, the mother will receive the drug starting the 28th week of pregnancy~     and continuing through labor and delivery. The infants will start drug treatment within the~     first 24 hours of life and continue for 6 weeks. Women who do not choose to take zidovudine~     according to this schedule will be offered standard treatment with a shorter course of drug,~     beginning with the 36th week of pregnancy, and no preventative treatment for their infants.~     All women will be offered education and counseling about the risks and benefits of~     breastfeeding and the risk of HIV transmission through breastfeeding. The objectives of this~     stage of the study are to:~        -  Assess the safety and tolerability of zidovudine given according to this protocol~        -  Assess the acceptance of and adherence to the zidovudine regimen in the protocol~        -  Assess the acceptance of education and counseling about breastfeeding~        -  Determine the mother-to-child HIV transmission rates in this study~        -  Determine the rates of illness and death through 12 months after delivery~        -  Determine risk factors for mother-to-child transmission of HIV~   "
245382|NCT00341783|"~     There are about 300-500 million cases of malaria worldwide each year, with 2-3 million~     deaths. Plasmodium falciparum, one of four types of malaria, is responsible for most of these~     deaths. Because of increasing resistance of this parasite to drugs and of mosquitoes to~     insecticides, a vaccine would be valuable in the fight against malaria.~      Don gu bougou, Mali, is an area of seasonal malaria transmission that is being investigated~     as a possible suitable site for testing investigational malaria vaccines. The goal of this~     study is to characterize the population of this site in terms of common hematologic (blood)~     and biochemistry parameters that may be used to determine eligibility for participation in~     vaccine trials. The study will also assess the prevalence of preexisting medical conditions~     that might affect assessments of vaccine safety and efficacy. Also, the natural immunity to~     antigens in the investigational malaria vaccines will be determined.~      Don gu bougou, Mali, was chosen because of its high malaria rates. Data will be collected at~     four time-points. At least 50 individuals will be recruited from each of the following age~     groups: 6 months-5 years; 6-10 years; 11-15 years; and 16-45 years. Village-wide consent will~     be obtained and about 25 of the 111 family compounds will be randomly selected. Individual~     consent will also be obtained.~      Enrolled volunteers will undergo a baseline medical history and physical examination. Blood~     will be collected for various tests, and, for women of childbearing age, urine pregnancy~     tests will be administered.~      At each of three followup visits, a brief medical history and physical exam will be~     conducted. Blood will be drawn for tests. Also, blood, urine, and/or stool tests not done at~     baseline will be done at one of the followup visits.~   "
245389|NCT00341692|"~     Breast cancer is the most common cancer among women in the United States. Breast cancer~     research has been hampered by the difficulty in collecting normal breast tissue. In this~     study, researchers will obtain samples of normal breast tissue from organ donors and will~     collect risk-factor data from next-of-kin.~      The purpose of this study is to learn how normal breast develops and responds to stresses~     that are known to increase a woman s chance of developing breast cancer.~      Following the breast-tissue donation from 20 volunteers, surgical technicians will make small~     incisions in the skin and tissue of the breast and remove several samples measuring about~     one-inch. Technicians also will take samples of the uterine lining to estimate the date of~     the last menstrual period. The tissue will then be sent to the National Cancer Institute for~     laboratory research studies. Steps will be taken to ensure that the identity of the~     participants remains confidential.~   "
245595|NCT00338910|"~     The primary objective of this study is to describe a possible effect of metronidazole on PK~     of budesonide in healthy volunteers.~   "
245383|NCT00341770|"~     Obesity is the consequence of an imbalance between energy intake and energy expenditure.~     Recent studies have suggested that the sympathetic nervous system (SNS) may be an important~     determinant of the rate of energy expenditure in man. Indirect assessments of the sympathetic~     nervous activity in Pima Indians have recently shown impaired SNS-mediated energy expenditure~     in this obesity-prone population. We plan to perform direct microelectrode nerve recording of~     the sympathetic innervation of the lower leg to directly assess SNS activity and examine its~     potential role in the regulation of metabolic rate and the development of obesity.~     Measurements will be performed in the basal state, in response to glucose feeding (75 g OGTT)~     and in response to glucose/insulin infusion. These studies also will help to disassociate the~     effect of insulin and glucose on the stimulation of SNS activity. Energy expenditure~     measurements will be performed over 24 hours in the respiratory chamber and for 2 1/2 hours~     before and during the euglycemic clamp. Results also will be used to determine possible~     racial differences between Pimas and Caucasians, since the risk for obesity is markedly~     different in these populations. To exclude the possibility of a normal SNS activity but~     with peripheral resistance to the action of norepineprine, we will perform adrenergic~     stimulation by isoproterenol to measure peripheral adrenergic sensitivity.~   "
245384|NCT00341757|"~     Family history of cancer is an important possible indicator of inherited cancer~     susceptibility, which has helped identify individuals and families at high risk of inherited~     cancers in research studies and clinical practice. While there are also various potential~     uses of family history of cancer data in cancer surveillance, the completeness and accuracy~     of family history of cancer data collected from the general population is unclear. In an~     effort to evaluate the feasibility of conducting a national surveillance study to determine~     the prevalence of family history of cancer in the U.S. population, the Risk Factor Monitoring~     and Methods Branch will undertake a pilot study, entitled the Family Health Study, that~     examines issues of data quality. In this study, a family history of cancer questionnaire~     (FHCQ) will be developed for surveillance purposes and administered to a random digit dial~     (RDD) sample of households in the state of Connecticut. Positive and negative reports of~     common cancers in the respondent's families will be validated against records of the~     Connecticut Tumor Registry (CTR) and other data sources.~      The objectives are to: 1) assess the agreement between respondent reports of specific cancers~     in first and second degree relatives and medical record-based reports, as measured by percent~     concordance; 2) quantify the sensitivity, specificity and predictive value of the FHCQ by~     cancer site; 3) evaluate the possible predictors of reporting accuracy, including cancer~     site, year of diagnosis, kinship relation of the relative to the respondent and the frequency~     and quality of their contact, overall family cohesiveness, respondent's own history of~     cancer, and demographic factors; 4) describe the completeness and reliability of family~     structure data.~      Validation of selected relatives' cancer status will be done through data linkage to the~     Connecticut Tumor Registry, other selected cancer registries, the National Death Index,~     Medicare claims data bases, state death certificate registries, or by obtaining consent to~     review available medical records from physicians and health care facilities. Self-reports of~     respondents' cancer status will also be validated since this may be a predictor of ability to~     accurately report family history. A pre-established tracing algorithm will be used to triage~     cancer reports into the medical records systems where true cancer status is most likely to be~     verified by the highest quality data. Validated cancer outco...~   "
245385|NCT00341744|"~     Providing Access to the Visual Environment is a pediatric low vision grant which has the~     ability to provide comprehensive, interdisciplinary low vision rehabilitation services to~     every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected~     vision of 20/50 or worse in the better seeing eye are prescribed optical devices to improve~     their visual functioning and trained to use the devices.~   "
245386|NCT00341731|"~     Polycystic Ovary Syndrome (PCOS) is manifested as a heterogeneous mixture of clinical and~     bichemical characteristics that complicate study of its etiology. It is currently unclear to~     what extent PCOS-associated traits (hyperandrogenism, hyperinsulinemia, insulin resistance,~     type 2 diabetes, dyslipidemia, hypertension, obesity, and coronary artery disease) are the~     result of environmental factors or genetic predisposition. We propose to conduct a twin study~     to investigate the possibility that environmental factors are important in the development of~     the PCOS phenotype. Twin studies are considered to be the gold standard for determining the~     extent of heritability of a trait. The proposal described here is only for Step 1 of a~     larger, multi-step study. The major goal of step 1 is to identify a large cohort of twin~     pairs, in which at least one member of each pair is likely to have PCOS.~      Participants for this study will come from the Mid-Atlantic Twin Registry (MATR). Many (3283)~     potential participants have already been identified based on their answers to a preliminary~     MATR screening questionnaire. Out of the approximately 7145 twin women of reproductive age~     who completed these MATR screening questionnaires, 1803 women reported irregular periods, 954~     reported ovarian cysts, and 526 reported both irregular periods and ovarian cysts. Many of~     the women in this last group are likely to have PCOS. They represent 7.4% of the total~     sample, matching current estimates of PCOS prevalence (4-7%) in reproductive age women. We~     will also add new twin pairs who meet the criteria (irregular periods and evidence of PCOS or~     cystic ovaries) as they are recruited into the MATR and take the preliminary surveys.~     According to MATR statistics, about 33% of twin pairs are monozygotic (MZ, identical).~     Therefore, approximately 174 of the 526 women likely to have PCOS are members of a MZ pair.~      Step 1 of the proposed study consists of a telephone survey of the 3282 women with irregular~     periods and/or ovarian cysts. The survey will be conducted by the MATR. The instrument to be~     used contains a series of simple and direct questions and will take about 10 minutes to~     complete. The questions were designed to identify PCOS and their content deals with the~     frequency of menstrual periods (six or fewer per year being a major diagnostic criterion), a~     previous diagnosis of PCOS, obesity, excess facial hair and other evidence of~     hyperandrogenism. The women will also be asked if t...~   "
245387|NCT00341718|"~     This study will describe the experience of patients with visible physical abnormalities in~     the genetics clinic when they are involved in teaching others about their condition.~     Information from this study may be used to enhance educational experiences in genetics~     clinics.~      Patients 18 years of age and older with a visible physical anomaly who have been seen by a~     genetics professional in the past 5 years may be eligible for this study.~      In a tape-recorded telephone interview, patients are asked about the following:~        -  Their experiences when visiting the genetics clinic~        -  The circumstances under which they have been approached to participate in teaching~          others~        -  Their perspective on specific teaching behaviors used in genetic consultations, and how~          this perspective is affected by their perception of their own visible difference~        -  The benefits and downsides of being involved in teaching others~        -  The circumstances under which they feel comfortable being approached by genetics~          providers to help teach others about their condition~        -  The conditions or circumstances that make some individual teaching experiences better or~          worse than others~   "
245449|NCT00340899|"~     Preterm delivery, preeclampsia and intrauterine growth restriction are leading causes of~     perinatal morbidity and mortality. Efforts to treat these syndromes have not been effective,~     most likely becuase these obstetric complications are the clinical expression of adaptive~     mechanisms of host defense developed in response to pathologic insults. Since the ultimate~     pathologic basis of disease is unclear, therapy for these syndromes has been largely directed~     at symptoms, which appear late in the development of the disease. The main purpose of this~     study is to perform an early and comprehensive exploration of maternal and fetal factors that~     predict the subsequent develpment of these obstetrice complications, so that early medical~     interventions may be tested in patients at high and low risk for adverse perinatal outcome.~   "
246721|NCT00323687|"~     There is an unmet medical need for potent ART regimens that make adherence to treatment even~     easier due to QD dosing, offer a good tolerability profile and fit into the daily life of~     patients.~   "
245390|NCT00341679|"~     This study will define the major genetic risk and protective factors for idiopathic~     inflammatory myopathies (IIM), a group of immune disorders affecting connective tissues such~     as muscles. It will also identify new environmental risk factors for IIM and identify immune~     responses in myositis and related diseases. There are many forms of IIMs, and the causes of~     these diseases are unknown. However, scientists suspect that they result when people with~     some genetic factors that predispose them-that is, put them at greater risk-are exposed to~     certain environmental triggers. Some of those triggers include food, drugs, biologics (such~     as a vaccine to prevent disease), medical devices and occupational exposures.~      Patients, including children under 18, who had a diagnosis of myositis, a related autoimmune~     disease, or a rheumatic disease, as well as their blood relatives, and control subjects who~     were in good health have already been recruited for this study.~      The evaluation consisted of one outpatient visit to the patient's doctor, who will obtain a~     medical history and conduct a physician examination. Patients spent 20 to 30 minutes to~     answer written questions. There was a blood collection of about 6 tablespoons. If there was a~     major change in patients' medical conditions, they were asked to return for a second~     outpatient evaluation to determine whether any of the blood tests or antibodies, which show~     an immune response, had changed. Blood samples collected will be used only for laboratory~     research studies. The samples have been identified by a code, and all other identifying~     information have been removed.~      During the study, researchers will explore possible environmental risk factors, including~     studies of infectious and non-infectious agents. They will analyze the blood for genetic~     markers and test for certain antibodies. Laboratory results will be evaluated as they relate~     to the signs, symptoms, and severity of patients' illnesses. That would help researchers to~     better understand patterns of the diseases and the outcomes for patients.~      This study will not have a direct benefit for patients. However, results from the study can~     be made available to patients' doctors for use in appropriate care. Also, it is hoped that~     information gained can help other people in the future.~   "
245391|NCT00341666|"~     This study, conducted by NIH and the University of Bamako in Mali, Africa, will study the~     effect of concurrent infections with malaria and filariasis on patients' immune response.~     Lymphatic filariasis is caused by infection with very small parasitic worms called Wuchereria~     bancrofti that are acquired from mosquitoes. The worms may cause no illness in many who are~     infected, but is some, they can cause swelling of the arms, legs, breast and genitalia, which~     may progress to permanent swelling referred to as elephantiasis. Malaria is caused by~     Plasmodium falciparum, another parasite that is spread by mosquitoes. It can cause fevers,~     headaches, body aches and weakness, and, if untreated, it can cause severe illness and death.~      The 8-month study will analyze measures of immune function in blood cells from people with or~     without filarial infections who become infected with malaria. The goal of the studies is to~     see if having a filarial worm infection affects immunity against malaria. Results of analysis~     of immune function in persons with malaria but without filaria infections will be compared~     with those harboring both filaria and malaria infections and also with results from healthy~     control subjects.~      Healthy individuals and patients with malaria and filarial infections between 1 and 8 years~     of age and between 18 to 65 years of age who live in N'Tessoni and healthy individuals living~     in Bamako, Mali (controls), may be eligible for this study.~      Participants have blood samples collected as follows during the study:~        -  A blood sample will be collected at the beginning of the study. Individuals found to~          have the filarial worm infection have a second sample drawn at nighttime when the~          filarial worms are present in the blood. Treatment for filaria infection will be offered~          to all infected individuals at the end of the study.~        -  A second sample will be collected during malaria season. Subjects will be interviewed~          about their health during the malaria season and re-tested for filarial and malaria~          infections with a finger-prick test. Those who test positive for malaria will be offered~          treatment to begin immediately after collection of the donated blood sample..~        -  A third sample will be collected after the end of the malaria season. Subjects will be~          interviewed again about their health and re-tested for filarial and malaria infections~          with a finger prick test. Those who have positive results for either infection will be~          offered treatment after collec...~   "
245392|NCT00341653|"~     We propose to add a collection of buccal cells to a school-based cohort of 7th graders in~     Wuhan, a large industrial city in China. The cohort study is being conducted by the Wuhan~     Public Health and Anti-Epidemic Station (Li Yan MD, director and principal investigator). The~     cohort study is designed to look at several outcomes. One is initiation of smoking. The~     second is respiratory health in relation to active and passive smoking and other~     environmental exposures that are prevalent in Wuhan. The respiratory outcomes include changes~     in pulmonary function, asthma and other respiratory symptoms. Collection of buccal cells is a~     noninvasive method of obtaining DNA. The addition of a genetic sample will enable us to~     examine candidate gene associations for asthma and childhood respiratory illness within an~     interesting and well-characterized Chinese population. In addition, it provides the~     capability to examine gene environment interaction with respect to common environmental~     exposures in Wuhan. The ability to examine gene-environment interaction can help to identify~     relatively subtle effects of pollutants such as environmental tobacco smoke which is becoming~     a very common exposure due to the major increase in smoking among Chinese men. Other~     exposures of interest in Wuhan are indoor coal burning and high ambient exposures to~     particules, ozone and nitrogen oxides. The proposed study has been approved by the human~     subjects committee of the Wuhan Public Health and Anti-Epidemic Station....~   "
245393|NCT00341640|"~     This study will provide information regarding the optimal dose and duration of nicotine~     replacement using the nicotine patch for a smoking cessation study of pregnant~     African-American women. Previous studies have shown that pregnancy, race and ethnicity can~     affect the way people metabolize nicotine. The information from this study may help~     scientists develop ways to help pregnant African-American women quit smoking and not start~     smoking again after delivery.~      African-American women 18-30years of age who are in the second trimester of a healthy~     pregnancy, who are carrying only one baby and who smoke 10 or more cigarettes a day may be~     eligible for this study. Candidates are screened with a medical history, physical examination~     and urine test. They receive counseling to help them quit smoking. Those who cannot quit~     smoking within 7 to 10 days after receiving counseling may be invited to join the study.~      Participants are admitted to a private room in the Pediatric Clinical Research Center at~     Children's National Medical Center in Washington, D.C., for 48 hours, during which time they~     are not permitted to smoke. After a wash out period, a nicotine patch will be applied~     according to these doses and schedules:~        -  21 mg patch for 24 hours~        -  21 mg patch for 16 hours~        -  14 mg patch for 24 hours~        -  14 mg patch for 16 hours~      An intravenous (IV) line is placed in the subject's arm and 12 blood samples are drawn~     through the line at intervals during the 48 hours. Twleve urine and saliva samples are also~     collected. Blood, urine, and saliva samples are analyzed for nicotine and cotinine (a product~     of nicotine metabolism) levels, and DNA will be collected studied for genes that are~     associated with nicotine and cotinine metabolism. Participants are interviewed about their~     urges to smoke, quality of sleep, etc.~   "
245394|NCT00341627|"~     Chordoma is an uncommon (400 case/year in the U.S.) and potentially fatal bone tumor derived~     from remnants of embryonic notochord. It occurs primarily in the axial skeleton and has a~     mean age at diagnosis of 55 years, with a range from early childhood to over 70 years. This~     tumor usually presents at an advanced stage and the associated mortality is high due to local~     destruction and distant metastases. Chordoma is rare in African-Americans and is typically~     sporadic; there are few reports of these tumors arising congenitally or within members of the~     same family.~      Recently, we have identified and studied one large family in which 10 relatives in three~     generations have chordoma; the inheritance pattern suggests transmission of a mutation in an~     autosomal dominant gene. Using information from this family, we have tentatively napped this~     gene to the long arm of chromosome 7. To confirm this finding, and to fine map and clone the~     gene, we need to study additional chordoma families. In an effort to identify such families,~     we have developed collaborations with four SEER registries covering the populations of~     Detroit, Los Angeles, Iowa, and New Mexico. Each registry will identify all chordoma cases~     diagnosed since 1988 and invite them (or the next of kin of deceased cases) to participate in~     our study. Through 1997, the registries have identified a total of 140 chordoma cases, 96 of~     whom are living. The registries will invite these patients (or their next of kin) to~     participate in the study. The study components include completion of a self-administered~     personal and family medical history questionnaire, retrieval of medical records and pathology~     reports pertaining to chordoma, and collection of paraffin-embedded chordoma tissue and~     buccal mucosal cells for genetic studies. NCI will carry out all the data collection~     activities for the study subjects identified through the Detroit registry. NCI will also~     conduct the buccal cell collection component of the study for all patients identified by the~     other three registries. These three registries will carry out all other study activities on~     these patients/next of kin and will send the data and slides prepared from the paraffin~     blocks to NCI. NCI will analyze the questionnaire data to determine if any unusual patterns~     of cancers other than chordoma or other medical conditions appear to cluster in families of~     the chordoma patients. Selected members of any families with two or more relatives with~     chordoma will be invited to participate in a separate clinical and molecular study conducted~     at NIH to try to identify the chordoma gene. DNA from the buccal cells and tumor blocks from~     all other patients with sporadic chordoma identified through the registries (likely to~     comprise most patients) will not be studied until we or others have identified such a~     gene....~   "
245395|NCT00341614|"~     Type 2 diabetics (non-insulin-dependent) are more than five times as likely to suffer an~     initial myocardial infarction (MI; heart attack) compared to nondiabetics.Female diabetics in~     particular, have a higher mortality rate for coronary artery disease (CAD) than male~     diabetics.C-reactive protein measurement in the clinical setting enhances the detection of~     individuals who are at high risk for cardiovascular disease (CVD), by providing additional~     predictive value.~      We propose to study the effects of a supervised exercise and diet intervention on~     cardiovascular disease risk in postmenopausal diabetic women. We will recruit 35~     postmenopausal, sedentary type 2 diabetics who will undergo a 3 month exercise and dietary~     intervention. They will exercise 3 times a week for 30 min in a supervised setting. Exercise~     mode will be aerobic and self-selected (i.e. treadmill, bike) at an intensity level of 50-85%~     VO2peak. Blood glucose will be monitored before and after exercise. The dietary intervention~     will consist of 6 meetings with a registered dietitian.~      The study is designed to test the following hypotheses:~        -  Cardiovascular disease risk measures will be different following a 3-month exercise and~          diet intervention.~             -  H1: Blood markers for coronary artery disease risk, as measured by CRP, TC, LDL,~               TG, FG, fasting insulin, and HbA1c, will be different following a 3-month exercise~               and diet intervention.~             -  H2: Anthropometric measures of coronary artery disease risk, as measured by WHR,~               will be different following a 3-month exercise and diet intervention.~             -  H3: Resting blood pressure, as measured by SBP and DBP, will be different following~               a 3-month exercise and diet intervention.~             -  H4: Total body fat, as measured by DXA, will be different following a 3-month~               exercise and diet intervention.~        -  Health-related measures will be different following a 3-month exercise and diet~          intervention.~             -  H1: Cardiorespiratory fitness, as measured by maximal oxygen consumption (VO2max)~               will be different following a 3-month exercise and diet intervention.~             -  H2: Bone-mineral density, as measured by DXA, will be different following a 3-month~               exercise and diet intervention.~             -  H3: Dietary measures (total daily kcal, and daily fat kcal) will be different~               following a 3-month exercise and diet intervention.~   "
245396|NCT00341601|"~     This study, conducted in Korea, will examine why some people are more susceptible to~     tuberculosis (TB) than others and why some strains of M tuberculosis (the bacteria that~     causes TB) are more difficult to treat or become resistant to drug treatments. The study will~     compare blood samples and other medical information from patients with different kinds of~     tuberculosis and with healthy volunteers to identify patient and bacterial characteristics~     that contribute to disease susceptibility, treatment failure, disease recurrence and~     multi-drug resistance.~      Healthy volunteers and patients with tuberculosis who are 20 years of age or older may be~     eligible for this study. Subjects are recruited from among patients receiving treatment for~     tuberculosis at the National Masan Tuberculosis Hospital in the Republic of Korea and from~     healthy people visiting government health care centers for annual medical checkups. The~     latter include people who have had TB but are cured; people who have been exposed to TB, but~     currently have no signs of disease; and those who have not been exposed to TB.~      Participants with tuberculosis undergo the following tests and procedures:~        -  Medical history, including past treatments for TB, and review of medical records~        -  Interview about home and work~        -  Sputum collection to test for the kind of TB bacteria present and for genetic studies of~          the bacteria~        -  Drug treatment for TB~        -  Blood draws as part of regular patient care, for HIV testing, and for genetic studies~        -  Chest x-rays as part of routine patient care~        -  In patients with recurrent disease, examination of the strains from both bouts of~          disease to determine if it is a recurrence of the same organism or infection with a new~          strain.~      Healthy volunteers undergo the following tests and procedures:~        -  Brief medical history~        -  Blood draw to look for exposure to TB and for genetic studies~        -  Review of previous x-ray to look for active TB~   "
245397|NCT00341588|"~     The incidence of testicular germ cell tumors (TGCT) has increased during the twentieth~     century and is of particular concern as it primarily affects young men. It is the most common~     cancer among U.S. males ages 25-34. The only well-described risk factors are cryptorchism~     (undescended testis), family history of TGCT, and personal history of TGCT. To better~     understand the environmental and genetic determinants of TGCT risk, a case-control study will~     be conducted among members of the U.S. armed forces. The study will include men who have~     donated a blood sample to the Department of Defense Serum Repository (DoDSR) between 1989 and~     2000. All DoDSR donors who have developed GCT will be matched to DoDSR donors who have not~     developed TGCT. Approximately 1,080 men with TGCT, 1,080 controls, and 2,160 mothers will be~     included in the study.~      The DoDSR serum sample will be tested for organochlorines levels, gonadotropin levels, and~     viral antibody titres. Each participant will donate a saliva specimen that will be used in an~     examination of genetic susceptibility. Each participant will also complete a questionnaire~     concerning a variety of possible risk factors such as physical activity, medical history,~     medication history, and other risk factors. The mothers of all participants will be invited~     to participate by completing a questionnaire concerning perinatal exposures and events and by~     donating a saliva sample.~      The three main objectives of this study are to:~        -  determine whether environmental endocrine modulators (i.e., chlorinated pesticides and~          polychlorinated biphenyls) are related to risk of GCT and, if so, whether their effects~          are augmented by other risk factors.~        -  determine whether genetic susceptibility to GCT exists and to characterize the~          environmental risk factors related to that susceptibility.~        -  determine whether there are distinct causes of GCT by relating the tissue structures of~          the tumors to the risk factors.~   "
245398|NCT00341575|"~     This study, conducted by NHGRI and the M.D. Anderson Cancer Center in Houston, Texas, will~     develop statistical approaches for modeling family social structure and apply these models to~     explore the role of family social structure in participation in genetic testing and~     counseling, disclosure of test results and adjustment to risk status. With recent genetic~     advances and the ability to test for hereditary illnesses, methods that provide an~     understanding of the family social structure and how that structure affects the dissemination~     of genetic risk information are increasingly important.~      The data for this study were collected by the M.D. Anderson Cancer Center as part of a study~     on family communication and family functioning with regard to genetic testing for hereditary~     nonpolyposis colon cancer (HNPCC). Relatives of people with HNPCC are more likely than the~     general population to get colon cancer and other types of cancer if they have inherited the~     gene alteration (mutation) that predisposes to the disease. This alteration can be passed on~     from a parent to some or all of his or her children.~      In the M.D. Anderson Cancer Center study, telephone interviews were conducted with 80 adult~     members of 16 extended families with a known gene alteration predisposing for HNPCC. These~     participants included people who had been diagnosed with an HNPCC syndrome cancer, their~     unaffected family members who were at risk of carrying a gene mutation for HNPCC, and their~     spouses. Participants were interviewed about their feelings, moods, coping style, and~     relationships with their spouse, relatives, and friends, about their willingness to have~     genetic testing, and about their feelings and beliefs about colon cancer, cancer screening~     and genetic testing and counseling. Some participants were asked about their family~     communication style and how the family coped with the idea of genetic testing and with the~     results, if testing was done.~      The information obtained from the current study may help facilitate family participation,~     communication and psychological adjustment regarding risk information about genetic diseases.~   "
245399|NCT00341562|"~     This study, conducted in Argentina at the Hospital Espa ol de la Plata and the Hospital Franc~     s de Buenos Aires, in collaboration with the NHLBI, will investigate possible genetic factors~     that lead to in-stent restenosis. A stent is a wire mesh tube that is surgically placed to~     open a blocked artery. The stent stays in the artery permanently, holding it open to improve~     blood flow. In the case of blocked coronary arteries, the stent improves blood flow to the~     heart muscle, relieving symptoms such as chest pain and shortness of breath. Sometimes~     re-growth of tissue within a stent, called in-stent restenosis, leads to narrowing of the~     artery, decreased blood flow, and a recurrence of symptoms. Genetic analysis may allow the~     identification of patient that may be at increased risk for in-stent restenosis and lead to~     methods of prevention and treatment.~      Patients 18 years of age and older who are undergoing coronary endarterectomy (surgery to~     remove plaque from an artery) to treat in-stent restenosis at the Hospital Espa ol de la~     Plata and the Hospital Franc s de Buenos Aires may be eligible for this study.~      Participants will have a blood sample drawn and undergo coronary endarterectomy. Tissue~     removed from the patient's artery or the stent during surgery will be analyzed for gene~     expression profiling and genotyping. The results will be studied along with information about~     the patients' medical history.~   "
245576|NCT00339157|"~     1. Main objective: To test the efficacy of anakinra treatment in children or young adults~          with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis~          (SO-JIA)~        2. Design: Double blind, randomized trial testing the efficacy of one month Anakinra~          treatment versus placebo (2 groups of 12 patients each). All the patients will be~          treated with anakinra during the following 11 months and the dose of corticosteroids~          will be gradually tapered (= descriptive part of the trial to assess the tolerance and~          efficacy over 12 months).~        3. Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients~          versus no more than 10% in the placebo group.~        4. Main inclusion criteria : diagnosis of SO-JIA (Durban consensus conference criteria),~          age: 2 to 20 years at inclusion, active, corticosteroid-resistant or -dependent disease,~          no previous IL-1ra treatment.~   "
245400|NCT00341549|"~     This study will try to identify the gene or genes responsible for myopia (nearsightedness)~     and to examine the relationship between myopia and near work. Myopia is the most common eye~     disorder in the world, affecting one in four Americans. Several studies indicate that myopia~     is inherited. The condition tends to cluster in families, so that studying families with this~     condition may facilitate finding the exact cause.~      Caucasian Americans and African Americans with myopia who are in general good health may be~     eligible for this study. People with a family history of myopia through several generations~     along one parent s side only, and in which more than one sibling has myopia are preferred.~     People who have severe diseases that involve myopia, such as Stickler s or Marfan syndromes,~     retinitis pigmentosa or diabetic retinopathy may not participate.~      Participants will undergo the following tests and procedures:~        -  Eye examination, including refraction~        -  Blood draw for genetic studies and possibly establishment of cell lines (collection of~          cells grown in the laboratory from an original tissue specimen) for future research~        -  Myopia Family Study Questionnaire and personal medical information questionnaire to~          provide information about other medical conditions that may influence the development of~          myopia; the vision status of their spouse and children, parents and siblings, and spouse~          s parents and siblings~        -  Risk Factor Questionnaire (for Jewish Orthodox community only) to assess the amount of~          near work activity done in childhood~   "
245401|NCT00341536|"~     This pilot study will examine the potential for health, diet and lifestyle research in Delhi,~     Kerala, and Kolkota, India. It will: 1) evaluate the adequacy of the existing infrastructure~     for a large-scale epidemiologic investigation and follow-up; 2) obtain a characterization of~     the Indian diet; 3) determine study end-points; 4) evaluate the feasibility of collecting and~     analyzing biologic samples within India; and 5) evaluate the ability of centers to recruit~     subjects and collect data.~      Indian men and women between 35 and 70 years of age who have resided in the study area~     (Delhi, Kerala, or Kolkota) for at least 1 year may be eligible for this study. Participants~     will undergo the following tests and procedures:~      Part A: Diet and Lifestyle (2 visits)~        -  Questionnaires on medical history and treatment practices, including questions on~          reproductive history~        -  Brief medical examination~        -  Body measurements, including height, weight, forearm circumference, thighs, hips,~          stomach, skin thickness of the back and triceps (back of the arms)~        -  Blood draw for research, including studies of gene changes that affect the way the body~          uses nutrients~        -  Collection of toenail clippings for research tests~        -  Interview about: 1) dietary habits and understanding of the relationship of diet to~          health; 2) lifestyle, work, and family health; and 3) moving history (how often subject~          has moved in the past 5 years, addresses of past homes, and plans for future moves)~      Part B: Understanding Diet (6 visits)~        -  Interview at each visit about food and drink consumed the day before the interview~        -  2 blood draws~        -  24-hour urine collection~        -  Physical activity monitor. The subject wears a small device placed on the belt or waist~          of the pants for a specified time to measure the amount of movement performed.~      Part C: Medical Follow-up Patterns (1 visit)~      -Answer questions about medical history, treatment practices, and dietary habits~   "
245402|NCT00341523|"~     Esophageal cancer is a common malignancy with a very poor prognosis. The principal reason for~     its poor prognosis is that most tumors are asymptomatic and go undetected until they have~     spread beyond the esophageal wall and are unresectable. Significant reduction in esophageal~     cancer mortality will require successful strategies to diagnose and treat more cases at~     earlier, more curable stages of disease. A successful early detection program will require an~     accurate, patient-acceptable screening test, confirmatory tests that can localize precursor~     and early invasive lesions, and one or more curative therapies that are acceptable to~     asymptomatic patients. This project includes five studies designed to evaluate techniques~     that may be useful in such an early detection program:~        1. The Cytology Sampling Study will estimate and compare the sensitivity of several~          cytologic samplers for identifying biopsy-proven dysplasia and cancer of the esophagus.~        2. The Mucosal Staining Study will evaluate whether mucosal straining can improve~          endoscopic localization of esophageal dysplasia and cancer.~        3. The Endoscopic Staging Study will evaluate how accurately endoscopic techniques can~          stage dysplasia and early invasive cancer of the esophagus.~        4. The Endoscopic Therapy Pilot Study will evaluate the feasibility, safety, acceptability~          and preliminary efficacy of endoscopic therapies for removing or ablating focal~          high-grade dysplasias and early invasive cancers of the esphagus.~        5. The Chemoregression Study will evaluate the ability of oral chemopreventive agents to~          reduce progression or cause regression of low-grade squamous dysplasia of the esophagus.~      This project will be carried out in Linxian, China, a county with extraordinary rates of~     esophageal cancer and a correspondingly high prevalence of the asymptomatic precursor and~     early invasive lesions that are needed for these studies. The project will be a collaborative~     effort of investigators from NCI, the Cancer Institute of the Chinese Academy of Medical~     Sciences, and several U.S. universities....~   "
245403|NCT00341510|"~     This study is a survey (Health Behaviors in School-age Children) sponsored by the World~     Health Organization to gather information about nutrition, dieting practices, physical~     activity, injuries, violence, relationships with family and friends, perceptions of school as~     a supportive environment, alcohol and tobacco use and drug use among adolescents, and about~     the communities in which students live. The U.S. sponsors of the survey are the National~     Institutes of Health and the Health Resources and Services Administration.~      The objectives of the international HBSC study are:~        -  To assess the prevalence of early adolescent health behaviors~        -  To identify psychosocial factors associated with adolescent behaviors~        -  To provide an opportunity for analyses of cross-national comparisons~        -  To provide an opportunity for analyses of trends in the U.S. and cross-nationally~      In addition to the above, the survey includes additional questions designed to provide~     information about areas of specific national interest, including the following:~        -  To assess the association of school, family, peers, and other environmental factors on~          health behavior and health status~        -  To assess the prevalence and identify factors associated with diet and physical activity~        -  To assess the prevalence and identify factors associated with bullying and risk~          behaviors.~      This is the third U.S. administration of the HBSC survey, previously administered in~     1997-1998 and 2001-2002.~      U.S. participants in the survey include about 15,000 students from 350 schools selected to~     take part across the country. In each school, one or two classes (about 25 students) in each~     grade 6 through 10 are picked randomly to participate. In one class period, the students~     complete the written survey, which has 80 multiple choice questions. Students do not put~     their name on the survey. When they finish the survey, the place it in an envelope and seal~     it shut. The envelopes are then put in a box. Reports will not include the names of~     participating counties, cities, school districts, schools, or students.~      The information collected from U.S. school children is compared with similar information~     collected from school children in 36 other countries. The survey is used to help set national~     priorities for school and youth programs, as well as to monitor the progress of these~     programs.~   "
245404|NCT00341497|"~     The purpose is to determine the extent of genetic damage in oral mucosal lesions ascertained~     in the study, whether specific genotypes are associated with genetic damage observed in the~     oral mucosal lesions, whether the extent of genetic damage changes over time, and what~     factors (e.g. smoking) contribute to those changes. Genetic damage indicators will include~     among others DNA adduct formation, particularly related to tobacco smoke carcinogens such as~     polycyclic aromatic hydocarbons. The genotypes of interest will be focused on these affecting~     carcinogen metabolism, (e.g., (CYP family), but may also include those related to growth~     factors, cell cycle control, and DNA repair. Microsatellite instability is another key~     indicator of damage that we plan to examine. This study was undertaken due to the paucity of~     data on the types of oral lesions seen in general dental practice and the limited knowledge~     of the natural history of these lesions.~      Persons were enrolled who had red and/or white oral lesions identified at 6 Dental Clinics at~     VA Medical Centers. The VA Centers involved were: Washington, DC; Atlanta, GA; Durham, NC;~     San Francisco, CA; Danville, IL; and San Antonio, TX.~      When a dentist found a red or white lesions in the course of routine outpatient examinations~     and care, obvious causes such as denture frictional lesions could be ruled out, and the~     normal standard of care for the lesion was biopsy, the patient was considered for enrollment~     into the study. The study was described to the patient, the consent for was signed, the~     patient received an intraoral examination to identify and characterize the oral lesions, the~     lesions were photographed, an oral epithelial cell sample was taken from the site and from~     the rest of the oral mucosa, and the patient was interviewed using a standard questionnaire~     that requested information about sociodemograhic, medical, and lifestyle factors,~     particularly tobacco and alcohol use all as part of the study protocol, and the patient~     received a biopsy as part of normal care. The biopsy report was obtained as was a small piece~     of the biopsy material that was not needed for patient diagnostic purposes. The subjects~     returned every 4-6 months for reassessment of the lesion or to determine that the lesion had~     not returned. The patients completed a questionnaire at each of these visits so that~     lifestyle factors such as tobacco and alcohol use could be reassessed. Also oral epithelial~     cell scrapings were obtained at each of these visits.~      This study is particularly valuable because longitudinal data was collected and because the~     data were collected over time using standard procedures.~   "
245405|NCT00341484|"~     An NCI goal is to identify every human gene that predisposes people to cancer. Recent studies~     of HIV-1 indicate that genetic polymorphisms can affect susceptibility to viral infections~     and that such alleles may be racially restricted, a range of racial and ethnic groups should~     be included in such studies. We propose to examine genetic determinants of infection with~     hepatitis B virus (HBV) and hepatitis C virus (HCV) in an ethnically diverse population of~     injection drug users (IDUs). HBV and HCV are important causes of hepatocellular carcinoma,~     but little is known about genetic factors that alter susceptibility to these infections.~     Subjects will be recruited in diverse inner-city neighborhoods as part of the University of~     California, San Francisco's Urban Health Study. Since 1986, this study has successfully~     recruited and evaluated IDUs from street-based settings. About half of the participants are~     African-American, one-third are white, 10% are Latino, and the remainder are Asian or Native~     American. The mean duration of drug use exceeds 20 years. About 80% of subjects have evidence~     of HBV infection and a similar prevalence of HCV infections is anticipated. We will enroll~     about 1500 subjects over a 13 month period. Archived, unlinked serum specimens may be~     obtained from previous enrollees to increase the sample size, as needed. Highly~     exposed-uninfected subjects will be ascertained on the basis of the serologic testing for~     each virus, as well as the duration and frequency of injection drug use. These highly~     exposed-uninfected subjects will be compared to infected subjects with regard to their~     frequency of genetic polymorphisms (chemokines, chemokine receptors, human leukocyte~     antigens, and others), in collaboration with scientists from NCI's Laboratory of Genomic~     Diversity.~   "
245406|NCT00341471|"~     The Building Futures for Youth (BFY) project is a pilot intervention program for 6th grade~     students and their parents in the District of Columbia public school system. The full~     intervention will include students in the 6th, 7th and 8th grades. The primary overall goal~     of the project is to help students learn to make healthy life choices and delay sexual~     initiation.~      Sixth-grade children and parents in four Washington, D.C., public schools will be recruited~     for this study. Children from two schools will participate in the BFY intervention program~     and children from two other schools will serve as controls. Participants are guided through~     three study phases, with each phase spanning one school year, as follows:~      Sixth-grade students are given a foundation in goal setting, decision-making and~     communication skills. They gain knowledge about puberty, reproduction, and the negative~     consequences associated with having a child at a young age. They learn strategies for getting~     out of situations in which they feel pressured to engage in sexual activity. Through lessons,~     activities, and discussions they are given tools to answer the following questions:~        -  Who am I? Students engage in self-reflection activities and discussions that allow them~          to become aware of their values, beliefs and strengths, increasing self-esteem and a~          positive self-image.~        -  What do I want for my life? Students engage in goal-setting activities, creating~          short-term and long-term goals and mapping out the necessary steps to achieve the goals.~        -  How do I get there? Students are instructed in decision-making, problem-solving and~          communication skills.~        -  How can having sex too early affect my life and the goals I want to achieve? Students~          explore the negative impact that engaging in sexual activity too early and getting~          pregnant or getting someone pregnant can have on their emotional, social and financial~          lives.~      Seventh grade students are given the tools and skills necessary to deal with a variety of~     challenges they may experience during their developmental years. They receive comprehensive~     sex education, in conjunction with life skills such as relationship negotiation, dating~     skills, violence prevention and problem-solving skills.~      Eighth grade students are guided through a series of activities that encourage students to~     translate knowledge gained in the 6th and 7th grade phases into long-term behavioral changes~     and risk reduction. Activities include writing and performing skills, creating an~     informational pamphlet, designing T-shirts and creating poetry that affirms the BFY message.~      In addition, students participate in a program of community service projects, such as the~     Anacostia River clean-up coordinated by the Earth Conservation Corps and Martin Luther King~     Day events coordinated by Howard University's Community Association and Project Change.~      Parents are provided skills training and information on a variety of issues relating to~     adolescent sexuality, parental monitoring and parent-child communication.~   "
245407|NCT00341458|"~     The Polish breast, ovarian and endometrial cancer study is a complex molecular epidemiologic~     study that is expected to enroll about 2,500 breast cancer, 450 ovarian and 450 endometrial~     cancer cases and 2,500 controls from Warsaw and Lodz, two major cities in Poland. This large~     population-based study combines state-of-the-art techniques of exposure assessment and~     collection of biological specimens to allow for the study of a wide range of biomarkers.~     Exposure information is obtained through detailed personal interviews, anthropometric~     measurements, physical activity monitors, and collection of dust samples from the~     participants homes. The collection of biological specimens includes blood samples processed~     as cryopreserved whole blood, serum+ blood clot, plasma+buffy coat+red blood cells; 12-hour~     overnight urine; paraffin embedded tumor and normal tissue; and fresh tissue from tumors,~     non-neoplastic breast tissue and mammary fat tissue. Subject enrollment started in June 2000~     and is expected to continue until January 2003 for breast cancer cases and controls and June~     2003 for ovarian and endometrial cancer cases. As of May 2002, we have identified 2,207~     breast, 138 ovarian and 235 endometrial cancer cases and 2,327 controls. The response rates~     to the interview are 81% for breast, 90% for ovarian and 83% for endometrial cancer cases and~     70% for controls. Most women who agree to the interview agree to provide biological specimens~     (about 90% of cancer cases and controls agree to provide a blood sample), anthropometric~     measurements (95% of breast cancer cases and controls) and wear a physical activity monitor~     (79% breast cancer cases and 90% of controls)....~   "
245408|NCT00341445|"~     The most important risk factor for asthma in inner-city homes may be exposure to cockroach~     allergen. In a previous study, the researchers reported that extermination alone, without~     resident education or professional cleaning, reduced allergen levels in inner-city homes.~     This result contradicted earlier findings by other scientists. This study seeks to confirm~     the researchers' earlier results, and to determine how intensive an effective extermination~     must be.~      The study will last one year and include 60 infested, multi-unit rental homes in North~     Carolina, divided into three groups. In the Treatment-1 group, researchers from North~     Carolina State University will set insecticide bait in initial and follow-up visits, as the~     highest standard for treatment. In the Treatment-2 group, one of five commercial pest-control~     companies will be randomly assigned to treat each home according to a 12-month, pre-paid~     contract. The third group will be a control group that receives no extermination treatment.~     In all homes, researchers will periodically survey the residents, monitor cockroach numbers,~     and monitor allergen levels in dust samples. If this study is successful, it will be used to~     plan future asthma prevention trials.~   "
245577|NCT00339144|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) or the~     maximum administered dose (MAD) of Dasatinib (BMS-354825) in patients in Japan.~   "
245578|NCT00339131|"~     The purpose of this study is to test the safety of a drug called Ultratrace iobenguane I 131~     that has radioactivity, to measure how long it takes for the drug to be absorbed and passed~     out of the body, and to measure how much radioactivity is absorbed into different tissues of~     the body.~   "
246053|NCT00332761|"~     The purpose of this study is to determine if Caduet will lower blood pressure to <140/90 mmHg~     and lower LDL Cholesterol to <100 mg/dL in subjects with hypertension and dyslipidemia who~     are not currently being treated for these medical conditions.~   "
245409|NCT00341432|"~     This study will compare the effectiveness of counseling plus use of a nicotine patch with~     counseling alone for helping pregnant women quit smoking. Smoking during pregnancy is the~     most preventable cause of fetal and newborn health problems such as low birth weight, fetal~     growth retardation, sudden infant death syndrome, spontaneous abortion, decreased lung~     function and premature delivery.~      African-American and Hispanic women 18 years of age or older, smoke cigarettes, and live in~     the District of Columbia metropolitan area may be eligible for this study. Candidates are~     recruited from the George Washington University and Providence Hospital prenatal health~     clinics. They are screened with a review of their medical records and a survey that includes~     questions about their age, residency, race and ethnicity, educational level and employment~     status, number of weeks pregnant, and exposure to cigarette smoke and other types of tobacco.~      Participants answer questions about their smoking behavior, then receive a 10-minute~     counseling session and watch a videotape about quitting smoking. Women who are not able to~     quit smoking in 1 week are then randomly assigned to one of two treatment groups. One group~     continues to receive counseling sessions during the remainder of their pregnancy; the second~     group receives nicotine patches as well as the counseling sessions. In addition, all~     participants watch a video about smoking and receive a guide to help them quit. Women who~     receive the patches must stop smoking completely. If they cannot stop immediately, their~     participation in the study ends. The behavioral counseling sessions for all the women are a~     series of conversations between the women and a trained counselor to help the woman through~     the process of quitting.~      Participants are followed during the study with six clinic visits and three telephone calls.~     During the first visit, the women answer a series of questions about their smoking habits and~     health concerns. A portion of the urine sample they provide during their routine prenatal~     visit is used by this study to assess their cotinine (a breakdown product of nicotine)~     levels. Saliva and breath samples to test for cotinine and carbon monoxide levels are~     collected at each visit. Saliva is collected by brushing the inside of the cheek with a~     cotton swab, and breath samples are collected by having the woman blow into a tube connected~     to a machine. Participants are evaluated four times during the study with questions about~     their smoking behavior.~      With the women's permission, their medical records, health, and treatments during pregnancy~     are reviewed. At the end of the pregnancy, the infant's weight and health are also reviewed.~   "
245410|NCT00341419|"~     This study will characterize the gene mutations responsible for pseudoxanthoma elasticum~     (PXE) and correlate them with disease manifestations in males and females. PXE is an~     inherited disorder that affects the connective tissue in some parts of the body. Calcium and~     other minerals are deposited in the connective tissue, causing changes in the skin, eyes,~     cardiovascular system and gastrointestinal system. Some effects of PXE can cause serious~     medical problems, while others have less impact. Symptoms often appear earlier and are more~     severe in females than in males, but there is no way to predict how the disorder will~     progress in any given individual.~      Candidates for this study are recruited through PXE International, an organization that~     provides patient support and supports research on the disease. The organization collects~     biological samples and medical information on patients and family members to help further~     research on the disease. Families that have samples from the patient, both parents, and at~     least one sibling may be eligible for this study. Grandparents and extended family members~     may be included in certain instances.~      Participants provide a blood sample, a sample of cells scraped from the inside of the cheek~     (buccal cells) and a medical history. The samples are analyzed for gene variants and the~     findings are correlated with disease signs and symptoms.~   "
245411|NCT00341406|"~     This study, conducted at Stanford University in Palo Alto, California, will examine how~     insulin metabolism and cardiovascular risk are altered in response to weight loss. Insulin is~     a natural hormone that causes cells to remove glucose (sugar) from the blood. People who are~     insulin-sensitive remove glucose efficiently. People who are insulin-resistant require more~     insulin to remove glucose from the blood.~      Adult volunteers will be recruited for this study through advertisements in local newspapers~     in communities around Stanford University.~      Participants will undergo the following tests and procedures:~        -  Insulin sensitivity testing: Before beginning the study, participants will be tested for~          insulin sensitivity. For the test, two small catheters (plastic tubes) are placed into~          two veins - one for infusing glucose, insulin, and sandostatin (a drug that blocks~          insulin secretion from the pancreas), and one for drawing blood samples. The infusions~          are done over 3 hours. Blood samples are collected before, during, and at the end of the~          study to measure how well the cells remove glucose from the blood in response to~          insulin.~        -  Research diet: Participants are assigned to a low-calorie diet tailored to the~          individual's metabolic rate. The diets contain either 40 or 60 percent of total calories~          as carbohydrates, 40 or 20 percent as fat, and the rest as protein. People with type 2~          diabetes who are taking diabetes medicine with have a diet of 45 to 50 percent~          carbohydrates, 35 to 40 percent fat, and the rest protein.~        -  Meal profile: Before beginning the diet and after 4 months on the diet, participants are~          tested for the effects of the various study diets on control of blood sugar and fats. On~          the day of each test, participants have a physical examination and provide a medical~          history. Then, a small catheter is placed in a vein. Blood samples are drawn before~          breakfast and then hourly for up to 8 hours.~        -  Participants who are diabetic are randomly assigned to take one of three diabetes~          medications - rosiglitazone, glucophage, or a sulfonylurea compound - to help control~          blood glucose levels.~        -  Magnetic resonance imaging: This diagnostic test uses a strong magnetic field and radio~          waves to show structural and chemical changes in tissues. During the scan, the~          participant lies on a table in a narrow cylinder containing a magnetic field, wearing~          ear plugs to muffle loud knocking and thumping sounds that occur during the scanning~          process. He or she can speak with a staff member via an intercom system at all times~          during the procedure.~      In addition to these procedures, patients may be asked to have a fat cell biopsy. This is~     done to determine whether insulin-resistant people have fewer fat cells but more fat per cell~     than insulin-sensitive people. For this test, a small piece of fat tissue is surgically~     removed, under local anesthetic, from an area of the lower abdomen. With the participant's~     consent, genetic testing may be done on the fat tissue sample to look for genes that may link~     central obesity to insulin resistance.~      Some participants may be asked to be followed for an additional 3 months after completion of~     the study for a continued weight loss program. The follow-up includes weekly visits for~     weight measurements and a review of food records.~   "
245412|NCT00341393|"~     This study will evaluate a system for predicting the effectiveness of antiretroviral~     treatment in African HIV clinics where standard testing methods for measuring viral load,~     such as RNA polymerase chain reaction, are not available or affordable. Without accurate~     tests to monitor viral load, treatment decisions often are based on insufficient clinical and~     immunologic information. This study will see if combined analysis of patients' antiretroviral~     treatment history, adherence to treatment, clinical findings and simple laboratory tests can~     predict whether their treatment is effectively lowering their viral load. An effective~     monitoring system such as this could reduce the number of patients kept on ineffective~     treatments for prolonged periods of time as well as reduce the development of drug~     resistance.~      HIV-infected patients 18 years of age and older who are being followed in the Adult~     Infectious Disease Clinic at Makerere University, Kampala, Uganda, and who have been taking~     antiretroviral treatment for more than 6 months may be eligible for this study.~      Participants' medical charts are reviewed and their medical history is taken, including~     questions about their treatment history, adherence to treatment, and changes in symptoms. A~     blood sample is drawn to determine viral load, CD4+ and CBC counts, and, if necessary,~     anti-viral resistance.~   "
245413|NCT00341380|"~     This study will investigate operative techniques to reduce the risk of tumor spread as a~     result of lung cancer surgery. Recent studies indicate that tumor cells may be released into~     the bloodstream due to handling of the lung during surgery, causing disease spread in~     patients whose tumor was previously confined to the lung. This study will examine whether the~     order in which the pulmonary vein (a vessel carrying blood from the lungs to the heart) and~     artery (vessel carrying blood from the heart to the lungs) are tied off during surgery~     affects the risk of tumor spread and disease recurrence.~      Patients 18 years of age or older with operable Stage I or Stage II non-small cell lung~     cancer and no evidence of tumor spread beyond the lung may be eligible for this study.~     Candidates will be screened with a medical history, blood tests, chest X-ray, and possibly~     mediastinal evaluation. This test involves inserting a tube into the chest cavity to look for~     signs of disease spread beyond the lung.~      All participants will undergo standard surgery for lung cancer. During the procedure, both~     the pulmonary artery and pulmonary vein are tied off; for this study, patients will be~     randomly assigned to have either the artery or the vein ligated first. Patients will be~     followed every 6 months for two years with blood tests and X-rays to look for disease~     recurrence.~   "
245414|NCT00341367|"~     This study attempts to identify genes that may increase or decrease the likelihood of sciatic~     pain (shooting pain down the leg) persisting 1 year after treatment of a herniated spinal~     disc. Many proteins in the nerves, spinal cord, and brain are involved in processing pain.~     These proteins vary slightly in different people. Animal studies have shown that rats and~     mice with certain types of proteins experience chronic pain after sciatic injury while those~     with other types do not. Better information about the role of genes in pain processing may~     lead to a test for the risk of chronic pain for specific individuals and more effective~     treatment approaches.~      This study will include people who participated in the Maine Lumbar Pain Study of the natural~     history of spinal pain. The Maine study included patients treated for sciatic pain caused by~     a herniated disc. In this study, patients who did not improve with medical treatment were~     referred for surgery to remove the disc. Of those referred for surgery, 275 elected to have~     the operation, and 232 did not. One year after surgical consultation, leg pain was reduced in~     81 percent of patients who underwent surgery. Of those who declined surgery, 56 percent~     improved after 1 year. This study will look for genetic differences in the non-surgical group~     that might reveal differences among those who improved and those who did not.~      Participants will provide a blood sample (approximately 2 tablespoons) for genetic testing.~     They will also provide information on the ethnic background of their parents and~     grandparents. Different gene variants occur in different ethnic groups, so information on~     ethnic background will help researchers know what gene variants to look for. Participants~     will complete a questionnaire about their smoking history, because the same protein in the~     brain that responds to nicotine may also play a part in decreasing or increasing pain. Also,~     some surgeons believe that smoking can interfere with spinal bone healing. Information from~     this study will help resolve this question.~   "
245415|NCT00341354|"~     This study, conducted at the San Gerardo Hospital in Milan, Italy, will examine whether a~     bacteriocidal-coated endotracheal tube (breathing tube) cleaned with a device called a Mucus~     Shaver is safe and effective in preventing hospital-acquired infections in patients who~     require prolonged mechanical ventilation in an intensive care unit (ICU).~      Pneumonia is the most frequent hospital-acquired infection in the ICU; its development is~     likely related to the use of a breathing tube. The tube is placed in the patient's trachea~     (windpipe) to assist breathing during and after an operation. Currently, breathing tubes in~     intubated patients are cleaned with a suction catheter that draws out secretions that~     accumulate in the tube. This method does not clean the tube completely, however, and within a~     few hours after the breathing tube is placed, bacteria may begin to grow inside the tube.~     Over time, as the patient breathes in and out through the tube, the bacteria may break free~     and enter the lungs, possibly causing pneumonia. In addition, the growth of bacteria in the~     tube decreases the size of the airway passage, making it more difficult to keep air moving in~     and out of the lungs.~      Previous studies have shown that breathing tubes coated with silver-sulfadiazine prevented~     bacterial growth in the patient's airways and that use of the Mucus Shaver prevented~     accumulation of secretions in the lumen of the breathing tube, keeping the tube open. This~     study will determine if use of the coated tube and Mucus Shaver in patients requiring~     prolonged mechanical ventilation is safe and if it can reduce bacterial growth, the length of~     intubation and mechanical ventilation, the occurrence of pneumonia and the length of time in~     ICU and hospital.~      Patients at San Gerardo Hospital who are 18 and older, who expect to have a breathing tube in~     place for more than 48 hours, and who are not allergic to silver-sulfadiazine may be eligible~     for this study.~      Participants are randomly assigned to have either a standard breathing tube and standard~     cleaning or a coated tube cleaned with a Mucus Shaver. At intubation, a sample of secretions~     is collected from the mouth, the lumen of the breathing tube, and the airways. The lumen of~     the breathing tube is then cultured every day. When the tube is removed, or on the eighth day~     of intubation, a sample of secretions is collected from the mouth, the lumen of the breathing~     tube, and the airways. After the tube is removed, it is examined for biological and~     microscopic analysis.~   "
245416|NCT00341341|"~     This study will explore beliefs and knowledge about genetics and smoking among smokers who~     have a first or second degree relative with advanced lung cancer, and whether their~     understanding of genetic risk influences their desire to quit smoking.~      Healthy adult smokers between 18 and 55 years of age who are first or second degree relatives~     (e.g., siblings, children, grandchildren, nieces, nephews, grandnieces or grandnephews) of a~     patient with advanced lung cancer who is receiving care at the Moffitt Cancer Center and~     Research Institute in Tampa, Fla. and the GUMC/LCCC, may be eligible for this study.~     Participants must be able to complete computer online surveys.~      Participants log on to a password-protected website to complete online educational sessions~     and surveys. The educational sessions include information on: 1) the role of smoking and~     genetics in the development of lung cancer; 2) glutathione S transferase (GSTM1), an enzyme~     made by the GSTM1 gene that cleans up toxins such as cigarette smoke and that may play a~     role in preventing lung cancer from developing; 3) pros and cons of being tested for GSTM1;~     and 5) a series of questions and answers about genetic testing. Participants are offered free~     genetic testing for GSTM1, and those who wish to be tested are sent materials to collect a~     sample from inside the cheek using a mouth rinse and return it to a laboratory at Duke~     University Medical Center. They later receive their results online.~      Participants also complete online surveys that ask about their risk perceptions, beliefs and~     attitudes related to lung cancer, emotional responses to their relative's diagnosis, smoking~     history and motivation to quit, reactions to information about smoking and genetic risk, and~     interest in receiving smoking cessation services. They are asked to review depictions and~     descriptions of smoking cessation materials offered through a quit smoking program at Duke~     University Medical Center and to evaluate the extent to which the various materials might be~     helpful. They are offered additional information among categories they can choose from.~      Participants are surveyed again by telephone 6 months after completing the online surveys.~   "
245417|NCT00341328|"~     The purpose of the study is to evaluate the efficacy and safety of Mycobacterium w in new~     lung tuberculosis patients. Mycobacterium w is a strain of bacterium which is being used as~     vaccine and adjunct drug against leprosy. This agent has also been found to be useful in the~     treatment of lung tuberculosis in limited number of patients.~      We are conducting this study in category-I patients( As per World Health Organization,Geneva~     classification of tuberculosis) having lung tuberculosis to see the efficacy and also to see~     any change in the immunological parameters.~   "
245418|NCT00341315|"~     This study will collect information on the height and weight of women who participated in a~     1998 study in Triana, Alabama, on the risk of breast cancer and benign breast disease in~     relation to environmental exposure to the pesticide DDT and similar chemicals. This~     additional information is needed to calculate the participants' body mass index (BMI), which~     is required for completing analysis of the data.~      The 1998 study-a collaborative effort of the National Cancer Institute, the Triana Area~     Medical Fund, and the College of Nursing at the University of Alabama at~     Huntsville-investigated possible effects of DDT and other compounds on the risk of breast~     cancer, predominantly among African-American women in the area of Triana, Alabama. The study~     was initiated as a result of medical findings showing high blood levels of DDT among the~     local population who had consumed fish from a tributary of the Tennessee River that had been~     polluted by the discharge over several decades of large quantities of pesticides from a DDT~     production plant.~      Women participating in the study had a mammogram, physical examination, breast examination,~     and blood draw, and completed a questionnaire on diet and lifestyle factors. In order to~     complete analysis of the data and determine whether there is an association between~     environmental exposure to DDT and related chemicals and breast cancer risk, additional~     information on BMI is required.~   "
245419|NCT00341302|"~     By the end of 1999, it was estimated that 1.2 million children were living with HIV~     infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in~     less-developed countries. Most HIV-infected children are infected by transmission from mother~     to child during pregnancy, at birth, or through breast milk. Antiretroviral medications,~     cesarean section before rupture of membranes, and avoidance of breastfeeding are ways to~     reduce the risk of transmission. This study will determine mother-to-child transmission rates~     and the effects on infants of exposure to antiretroviral medications and mode of delivery.~      Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled~     during the first year of this 5-year study. HIV-infected women will be evaluated during~     pregnancy, during delivery, and 6 months after delivery. At each visit, a history will be~     taken and physical examination given; blood will be collected for laboratory tests.~      HIV-exposed infants will be evaluated through 6 months of age. At each of 2 visits, a history~     will be taken and physical examination given; blood will be collected for laboratory tests;~     and growth will be assessed.~   "
245420|NCT00341289|"~     This study will examine the relationship between swimming lessons, swimming ability, and~     other risk factors or protective factors, and the risk of drowning among children. The~     study's primary focus is on children between 1 and 4 years of age, with a secondary focus on~     older children up to 19 years of age. Drowning is the second leading cause of accidental~     death among children under 5 years of age, with drowning rates peaking among 1- to 2-~     year-olds.~      The study will examine the circumstances of cases of children between 1 and 19 years of age~     who have drowned in a body of water where swimming ability might have been a risk factor,~     such as a pool, Jacuzzi, hot tub, pond, lake, river, canal quarry, irrigation ditch, dam, or~     ocean. (Drowning is defined as death from asphyxia while submerged, or within 24 hours of the~     submersion.)~      The victims' parents or guardians will be interviewed about their child's general health,~     temperament, motor development, swimming ability, history of swimming lessons, and exposure~     to water. In addition, they will be asked about environmental factors related to the child's~     drowning, such as if a lifeguard was present or if, in the case of a pool drowning, there was~     a fence around the pool. They will be asked about parental norms regarding child supervision~     and pool-provider advice regarding swimming instruction. Parents of older children will be~     asked about their child's risk-taking and sensation-seeking behaviors. Information on~     additional risk factors, such as the remoteness of the site of the drowning and the victim's~     blood alcohol level will also be obtained.~      The above information will be compared with similar information gathered from parents of~     control subjects-that is, children who are the same age as the victims and who live in the~     same geographic area. For adolescent cases, information about swimming in unguarded sites or~     drinking alcoholic beverages while in or around water will be obtained from direct interviews~     with adolescents, as parents may not have accurate information in these areas.~      The information gained from this study will provide guidance for the development of~     interventions to prevent childhood drowning.~   "
245421|NCT00341276|"~     The overall goal of this project is to understand the role of genetics in the etiology and~     prevention of upper gastrointestinal cancer, primarily esophageal cancer, but also cancers of~     the gastric cardia and body.~      Esophageal cancer is the second most common cause of cancer death in China and the seventh~     most common cause of cancer death worldwide. Evidence suggests that genetic factors may play~     an important role in the etiology of this malignancy, and identification of esophageal cancer~     susceptibility genes may allow screening of populations to identify persons at particularly~     high risk, who could then be targeted for prevention strategies (e.g., chemoprevention or~     early detection). There are several lines of evidence supporting the idea that there is~     genetic susceptibility for esophageal cancer in high-risk Chinese populations, including an~     association of positive family history with increased risk, evidence of familial aggregation~     of cases, and segregation analyses suggesting Mendelian inheritance in high-risk families.~      Several different but complementary approaches will be used to identify esophageal cancer~     susceptibility genes. (Because of etiologic similarities and for logistic reasons, parallel~     efforts will be made with gastric cardia and body cancers.) First, a tumor/non-tumor study~     will be conducted in which a biological specimen bank consisting of samples (tumor,~     non-tumor, venous blood, finger stick blood, and buccal cells) from several hundred cases of~     esophageal, gastric cardia, and gastric body cancers will be developed in Taiyuan that can be~     used for the identification of esophageal (as well as gastric cardia and body) cancer~     susceptibility genes and potential early genetic markers of these cancers. High-density~     genome-wide scans with microsatellite markers will be used in a limited number of cases to~     identify potential hot spots followed by further testing of these hot spots and other~     candidate markers in additional tumor/non-tumor samples. Premalignant morphologic lesions~     will also be examined. Second, blood samples for DNA will be collected from approximately 100~     healthy individuals from high-risk (Yangcheng County) and low-risk (Beijing) areas to examine~     potential population differences in polymorphisms for selected genomic markers. Third, a~     large case-control study with cancers of the esophagus, cardia, and body of stomach will be~     conducted to evaluate polymorphisms in the candidate markers identified in other components~     of this project, and to evaluate gene-environment interactions. Finally, a family study will~     be conducted to evaluate linkage of candidate markers with cancer in families having 2 or~     more cases with cancers of the esophagus, cardia, and/or body of stomach.~   "
245422|NCT00341263|"~     This study will examine levels of hormones, such as estrogen and testosterone, in maternal~     and umbilical cord blood to compare hormones between mothers who are having twins and mothers~     who are having one baby. It will investigate whether hormone levels in twin versus singleton~     pregnancies influence the babies' risk of developing breast, prostate, and testicular cancers~     later in life.~      Pregnant women 18 years of age and older who do not have preeclampsia, chronic hypertension,~     pre-pregnancy or gestational diabetes, thyroid disease, or other major pregnancy~     complications are eligible for this study. Participants will be recruited from the obstetrics~     and gynecology practice at the Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire.~      Participants will have a blood sample drawn from their arm during their third trimester~     prenatal visit and again when they are admitted to the hospital for delivery. After the baby~     is born, a blood sample will be collected from the cut umbilical cord. Information about the~     pregnancy and delivery will be collected from the mother's medical chart, and information~     about the baby's size will be obtained from the baby's medical chart.~   "
245423|NCT00341250|"~     This study will test an experimental vaccine called AMA1-C1 in children to see if it is safe~     and if it reduces episodes of malaria parasitemia (parasites in the blood) in children~     exposed to malaria. Malaria affects about 300 million to 500 million people worldwide each~     year, causing from 2 million to 3 million deaths, mostly among children less than 5 in~     sub-Saharan Africa. It is the leading cause of death and illness among the general population~     of Mali in West Africa. Increasing drug resistance to the malaria parasite and widespread~     resistance of mosquitoes (the insects that transmit the parasite) to pesticides are reducing~     the ability to control malaria through these strategies. A vaccine that could reduce illness~     and death from malaria would be a valuable new resource in the fight against this disease.~     AMA1-C1 is an experimental vaccine developed by the NIAID. Tests of AMA1-C1 in 87 healthy~     people in the United States and in Mali found no serious harmful side effects of the vaccine.~      Two- and three-year-old children who live in Don gu bougou or Bancoumana, Mali, and are in~     general good health may be eligible for this study. Candidates are screened with a medical~     history, physical examination, and blood and urine tests.~      Participants are randomly assigned to receive two injections (shots) of either AMA1-C1 or a~     Haemophilus influenzae type B vaccine called Hiberix® (Registered Trademark), which is~     approved and used in Mali. All shots are given in the thigh muscle. Before the first shot, a~     small blood sample is obtained to make sure the child is well and to see if he or she has~     antibodies to the malaria parasite. The second shot is given 4 weeks after the first. After~     each shot, participants are observed in the clinic for 30 minutes. They return to the clinic~     1, 2, 3, 7 and 14 days after each shot for a physical examination. Blood samples are drawn at~     some visits to check for side effects of the vaccine and to measure the response to it.~      During the rainy season after the second vaccination, subjects come to the clinic once a~     month for an examination. Any child who has been ill with a disease that could be malaria has~     a blood sample collected by fingerstick to test for malaria and to learn about the malaria~     parasites causing the infection. Every fourth visit a fingerstick sample is taken regardless~     of whether the child has been sick. If a child becomes sick at any time during the study, he~     or she will be brought to the clinic for examination a...~   "
245424|NCT00341237|"~     This study conducted by the NIEHS and the University of North Carolina Medical Center will~     create and maintain a biorespository containing the genetic material (DNA) from up to 20,000~     individuals recruited from North Carolina. These samples will allow scientists to look for~     differences in each individual s DNA. These differences are not known to be associated with~     any condition or disease to date, but the purpose of the study is test these differences for~     possible susceptibility to (or protection to) common conditions such as asthma,~     cardiovascular disease, cancer and many others. Many of the differences to be studied are in~     environmental response genes. These genes determine the various ways humans respond to toxic~     substances in the environment, their diet and lifestyles (e.g. no exercise vs. exercise), and~     exposures to other substances, e.g. therapeutics.~      Participants will be recruited from the general NC population through health fairs, studies~     drives at community venues and corporations, and from out patient clinics within the~     University of North Carolina health care system. Participants can also visit one of two~     locations in the Research Triangle area to volunteer for this study. All participants will be~     asked to provide a blood sample and some basic information on their gender, race and~     ethnicity, and will be compensated for their time by receiving $20.~      DNA will be extracted from the blood, encrypted with a secret identification number, and~     placed in the registry's biorepository. The registry will exist for up to 25 years. During~     that time, the DNAs will be available to researchers to look for the differences in the DNAs~     as described above. Participants who have certain differences might be asked to participate~     in a future study of people with the same DNA differences. The future studies will most~     likely involve filling out a questionnaire or participating in a telephone survey, but may~     involve being interviewed or having a physical examination or laboratory evaluation,~     including blood tests. Participants will be asked to update their contact information once a~     year for up to 25 years.~   "
245430|NCT00341159|"~     This study will continue to analyze data collected by the Women's Contraceptive and~     Reproductive Experiences (CARE) study. The CARE study was designed to evaluate the~     association between reproductive factors and risk of breast cancer in white and~     African-American women in the United States.~      The present study is not recruiting additional participants. The original study enrolled~     4,575 women with breast cancer and 4,682 control subjects between 35 and 64 years of age~      All participants provided a blood sample for genetic study. The samples were analyzed for~     variants (mutations) in the BRCA1 and BRCA2 genes, the vitamin D receptor gene, the androgen~     receptor gene, and the insulin-like growth factor-1 gene.~      In addition, all participants were interviewed to obtain information related to breast cancer~     risk, including a history of reproductive, menstrual, oral contraceptive, and hormone~     replacement therapy use; lifestyle factors such as smoking, alcohol use, body weight, and~     physical activity; history of medical conditions and procedures; demographic characteristics,~     such as age, race, marital status, and so forth; and a detailed family history of cancer.~   "
245579|NCT00339118|"~     The purpose of the study is achieve standardization treatment of low and intermediate risk~     rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high~     risk patients by the addition of doxorubicin as induction treatment and at the maintenance~     phase.~   "
245425|NCT00341224|"~     As an antidote to juvenile aggression and violence, which has increased in recent years,~     group mentoring offers a viable alternative to intensive one-on-one mentoring. However, no~     group-mentoring programs have been evaluated.~      The purpose of this study is to assess the efficacy of a school-based, group-mentoring~     intervention designed to prevent aggressive and deviant behavior among early adolescents.~      Study participants will be incoming 6th grade students from two inner-city Baltimore middle~     schools and their parents. Approximately 1,400 students and their parents are expected to~     participate. All 6th grade students in these schools are eligible for the study.~      Weekly student group-mentoring sessions are the principal component of this study. These~     groups will be held during the school day and will be designed to increase social skills and~     encourage academic engagement, restraint, and problem-solving. A master's level professional~     will direct and conduct these intervention activities, which will employ the use of field~     trips, cooperative games, discussion of real-life situations, and role playing.~      Students will also complete a 1-hour written survey each fall and spring from grades 6-8~     about the program and about attitudes and behaviors related to school involvement and staying~     healthy and safe. Study staff will contact participants' teachers and review their past and~     current school records, including attendance, grades, and disciplinary information.~      Parents may be asked to participate in group meetings and will complete in-person or~     telephone interviews (about 20 minutes each) about similar information over a 3-year period~     (6th grade to 8th grade).~   "
245426|NCT00341211|"~     The Viral Epidemiology Branch (VEB) of the National Cancer Institute (NCI) conducts research~     on viral infections and their associations with various diseases including AIDS and cancer.~     For some research questions, specimens are available from case subjects as part of ongoing~     protocols but are not available from normal control subjects (i.e., those without the~     infection or disease under study) to whom the case subjects can be compared. This protocol is~     to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid~     such as saliva, urine, or tears) from healthy volunteers.~   "
245427|NCT00341198|"~     Autoimmune diseases may involve nearly any organ and are characterized by abnormal activation~     or response of certain cells. Evidence suggests that farm work, exposure to silica from~     farming activities and exposure to pesticides may contribute to the development of autoimmune~     disease. Associations between autoimmune diseases and farming, however, have not been~     extensively investigated, and exposure data in the currently available studies are extremely~     limited.~      One of the major challenges in conducting population-based research on autoimmune diseases is~     case ascertainment. Self-report of previous diagnosis has proven to be unreliable. This~     protocol outlines a strategy to confirm self-reported diagnoses of systemic autoimmune~     diseases (rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and Sjogren~     syndrome) within the Agricultural Health Study group (AHS; a group of licensed pesticide~     applicators and spouses who completed a questionnaire). The confirmed cases will constitute a~     refined case group to allow analyses of pesticides and other farming-related exposures as~     possible risk factors for these diseases using data that have already been collected.~      Subjects will be selected from participants in the AHS who reported one of the diseases being~     studied. A short telephone interview will be conducted with participants, who will be~     requested to provide written consent for review of information from medical records. To~     confirm the self-diagnosis, participants' physicians will be contacted. Specific information~     will be requested in the form of a checklist. Responses will be reviewed for evidence of~     diagnosis and classified as confirmed, probable, physician-diagnosed, or unconfirmed.~      Secondary objectives of this study are to:~        -  assess the correct interpretation of conflicting self-reports that are provided at two~          different times.~        -  evaluate the usefulness of specific questions that could potentially be used in future~          studies to validate self-reported cases of rheumatoid arthritis in men.~   "
245428|NCT00341185|"~     We propose to study the prevalence of thyroid nodules and cancer in relation to radiation~     dose, in a defined cohort of Kazakhstan residents exposed as children to radioactive fallout~     from atomic bomb tests at the neighboring Semipalatinsk Test Site (STS). The population near~     the STS is believed to have received radiation doses from fallout that were much higher than~     that experienced by any population of comparable size in the US. The study population is a~     defined cohort of 20,000 residents, half of whom, in 1960, resided in heavily-exposed~     villages; the other half lived in lightly-exposed villages. The population is rural, with a~     diet that was and is heavily dependent upon fresh milk from household or local cows and~     therefore likely to have led to ingestion of radioactive iodine from fallout. The study is~     two parts.~      The first part involves a cytogenetic assay for radiation biodosimetry purposes of peripheral~     lymphocytes obtained from blood samples donated by 40 cohort members with individuals~     radiation dose estimates. Blood samples will be collected from 25 putative high-dose and 15~     low-dose cohort members and processed or cytogenetic assay using fluorescent in situ~     hybridization (FISH) for stable chromosome aberrations in peripheral lymphocytes. This~     biodosimetric validation assay, will be carried out by Nailya Chaizhunusova, chief of~     cytogenetics at the Scientific research Institute for Radiation Medicine and Ecology, in~     collaboration with Dr. Tracy Yang at the NASA Johnson Space Center in Houston, Texas. It~     should be possible to detect gamma radiation doses as low as 150 mGy.~      The second part will involve thyroid screening by ultrasound in selected villages. The~     population to be screened will comprise 100-1500 members of the study cohort exposed as young~     children to high fallout levels, and equal numbers of comparable ages exposed to little or no~     fallout. Fine needle aspiration biopsy will be performed, under separate informed consent, if~     the palpation and ultrasound results suggest presence of a tumor. Presence and malignancy of~     tumor will be determined by cytopathology. Subjects with evidence of thyroid disease will be~     referred to thyroid specialists at the Semipalatinsk State Medical Academy. Finger stick~     blood samples will be obtained to assess thyroid function using RIA methods with coated tube~     technology for T4 and TSH. The most sensitive statistical comparisons are expected to be~     dose-response analyses with respect to prevalence of thyroid nodules, which are common and~     known to be associated with radiation dose. Comparisons in terms of thyroid cancer, and~     benign and malignant neoplasms combined, are likely to be less sensitive but of acceptable~     power if risks associated with chronic radiation in this population are similar to those~     associated with acute exposure to X-ray or gamma radiation in other populations.~   "
245429|NCT00341172|"~     This study will evaluate the role of certain gene variants on the onset and course of~     cytomegalovirus (CMV) retinitis-a severe infection affecting the eye-in patients with AIDS.~     Symptoms include blurry vision, eye pain, photophobia, floaters, eye redness, and impaired~     vision. Left untreated, it can cause blindness. The study is done in collaboration with~     investigators of the Longitudinal Studies of the Ocular Complications of AIDS (LSOCA) at the~     Johns Hopkins University School of Medicine. The purpose of the LSOCA study is to learn about~     how HIV and other infections associated with AIDS and their treatments affect people's eyes~     and sight.~      Blood samples previously collected from patients participating in the LSOCA study will be~     analyzed for gene variants. These differences will then be correlated with the patients'~     clinical data to try to discover the role of gene differences among patients on the~     following: susceptibility to CMV and related problems; development and course of CMV; and~     response to HAART (highly active antiretroviral treatment), particularly in CMV onset and~     pathology.~      The study will use blood samples and clinical information previously collected from patients~     during their participation in LSOCA. The materials will be identified with a numerical code~     linking the samples and clinical data. No additional procedures will be performed on patients~     for this study.~   "
245580|NCT00339105|"~     The purpose of the study is to assess the usefulness of high Frequency mid-QRS analysis in~     identifying the ischemic origin of patients presenting to the Emergency Room (ER)with Chest~     pain.~   "
245581|NCT00339092|"~     This study will evaluate the effectiveness of a modified directly observed therapy program in~     increasing antiretroviral therapy adherence in poor, HIV-infected residents of urban~     communities.~   "
245432|NCT00341133|"~     The objective of these studies is to identify genetic factors that contribute to the~     pathogenesis of complex congenital heart disease and other more rare conditions resulting~     from disturbances in organ positioning. These are a group of medical conditions that are~     thought to stem from a poorly understood disturbance in the establishment of the basic body~     plan in the embryo. While the outside of the human body is generally symmetric with mirror~     image left and right sides, the positions of some internal organs are distinctly asymmetric.~     For example, the heart could not function properly as a mechanical pump if its connections to~     major blood vessels retained their initial symmetry. The left ventricle of the heart normally~     pumps blood to the body, while the right ventricle normally pumps blood to the lungs.~     Reversals in these blood vessel connections can be fatal. Similarly, the gut~     characteristically loops in a counterclockwise direction placing the stomach on the left side~     in most cases. Rare laterality anomalies can occur if this looping is in the other direction,~     or randomized (equally likely to loop in either direction). Serious medical problems can be~     caused by disturbances in the establishment, or maintenance of left-right (L-R) differences~     as key organs are developing in the embryo.~      We have established formal collaborative agreements with three major centers who have~     collected a large number of coded cases of congenital cardiac disease. Our research objective~     is to try to understand if specific genetic changes can contribute to a range of cardiac~     malformations. We utilize mutational analysis of candidate genes as our principal tool to~     study the genetics of L-R axis malformations. This protocol is also open to other conditions~     whose basis is also thought to result from L-R problems. In all cases, the patients continue~     under the care of the referring physician. We anticipate a minor role of NIH researchers and~     genetic counseling services if subjects either do not have, or cannot afford, similar~     services in their local area.~      This is not a treatment protocol. Our empiric ability to generate medically significant~     research results is limited by the extensive genetic and other etiologic heterogeneity.~     Therefore, this research is not a diagnostic study. At this stage of research, we are not~     sufficiently confident that our research results will have direct medical implications for~     research subjects.~      Results that are of potential medical importance will be discussed with the primary physician~     who is (in most cases) a trained cardiologist (and/or medical geneticist). We will emphasize~     that these are only preliminary research findings, that they are not CLIA-approved, and must~     be disclosed to the patient or included in the medical record. Repeat testing in a~     CLIA-approved lab under another protocol would be required before the genetic information~     could be shared with the patient and family.~   "
245433|NCT00341120|"~     This study is being conducted at the University Hospital of Lund University in Malmo, Sweden,~     in collaboration with the U.S. National Institute of Child Health and Human Development. The~     study will try to identify genetic causes of impaired sperm production and male infertility.~     It will focus on the possible role of the MTHFR and CBS genes, which regulate absorption and~     metabolism of the vitamin, folate in infertility. If the nutritional intake or metabolism of~     this vitamin is related to male infertility, then this cause of infertility would be~     potentially curable.~      Fertile and infertile men between 20 and 45 years of age may be eligible for this study.~     Criteria include the following:~        -  Fertile men: men whose partners are younger than age 40 and are attending Lund~          University prenatal clinic; who have fathered one or more pregnancies and who stopped~          birth control to achieve the present pregnancy; who achieved the present pregnancy in~          less than 12 months of unprotected intercourse.~        -  Infertile men: men referred to the Scandian Andrology Centre whose infertility is~          unexplained, whose partners are younger than age 40 and who have had regular sexual~          intercourse without contraception for at least 12 months without achieving a pregnancy.~      All participants will have the following tests and procedures:~        -  Complete a questionnaire providing information about their reproductive and medical~          history and recent dietary history;~        -  Provide blood samples for analysis of red cell folate, plasma folate, plasma~          homocysteine, plasma B12, and for genetic evaluation;~        -  Provide a semen sample for routine analysis, including volume, sperm concentration,~          sperm motility, and sperm morphology.~      In addition, infertile men will undergo a physical examination and review of their medical~     records.~   "
245434|NCT00341107|"~     Research and development in genetic testing for cancer susceptibility genes has advanced~     rapidly in recent years, allowing healthy individuals, cancer patients, and their families to~     determine if they carry mutations which increase their risk of breast, ovarian, prostate,~     colon, and other cancers. Initial efforts have unfolded primarily in academic medical centers~     targeting families at high risk for cancer. There is currently no information available for~     assessing the prevalence of genetic testing for cancer susceptibility genes at the national~     level, or for evaluating the knowledge of and attitudes toward such testing among primary~     care physicians. The objectives of this survey are to determine the utilization of genetic~     tests by physicians at the national level; to ascertain physician knowledge of available~     genetic tests for specific cancer susceptibility genes, to examine physicians' general~     attitudes toward testing, and; to explore possible variation in utilization and~     knowledge/attitudes by medical specialty, type of practice, year of training completion,~     board status, urbanicity, and geographic region. The primary research question that this~     survey will address is what is the prevalence of use of genetic testing for cancer~     susceptibility among primary care physicians in the U.S.? The survey will also assess whether~     there are statistically significant differences in 1) self-reported knowledge, current use~     of, and future intentions to use genetic testing for cancer susceptibility, and 2)~     perceptions of barriers to testing, among primary care physicians by their type and location~     of practice, and recency of training. Primary care physicians (internists,~     obstetrician/gynecologist, family and general practitioners) will also be compared with~     specialty groups (gastroenterologists, surgeons, urologists) and oncologists with respect to~     their use, attitudes towards, and knowledge of, genetic testing for cancer susceptibility. A~     questionnaire is being administered by mail, telephone, facsimilie or Internet to a~     nationally representative sample of 2,100 physicians. Responding physicians select their~     preferred response mode. Study participants are primary care and specialty physicians with~     active licenses to practice medicine in the U.S. A data file with personal identifiers~     deleted will be prepared for statistical analysis to estimate the prevalence and determine~     predictors of use and intentions to genetic tests for inherited cancer susceptibility.~   "
245435|NCT00341094|"~     The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and~     other radioisotopes of iodine in the atmosphere, contaminating thousands of square kilometers~     and exposing millions of people. For this study, a well-defined subset of Ukrainian children~     aged 0-18 years or in utero at the time of the accident are being identified and examined by~     well-trained specialists for thyroid disease every two years for at least three cycles. The~     study is a collaborative effort of research in Ukraine and the United States.~      The cohort will include approximately 13,000 persons who were children in 1986, all or most~     of whom have had their thyroids measured for radioactivity during the weeks immediately~     following the accident (or whose mothers had measurements taken while the child was in~     utero). Under a rigid research protocol these subjects will receive diagnostic thyroid~     examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory~     tests, and, if indicated, fine-needle aspiration biopsy. Interview information regarding~     residential, health, diet and lifestyle history will also be collected. All subjects will be~     followed for thyroid cancer morbidity and mortality. Thyroid cancers will be confirmed by~     expert pathology examination of tissue.~      In addition to the analysis of thyroid radiation measurements made in May-June, 1986, efforts~     will be made to reconstruct each person's exposure and to estimate the radiation dose to the~     thyroid. This will involve the reconstruction of deposition patterns and environmental~     pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of~     each person throughout the exposure period.~      The aim of the study is to carry out valid and credible assessments of the early and late~     morphologic and functional changes in the thyroid glands of persons exposed to radiation from~     radioactive materials released as a consequence of the Chornobyl nuclear power plant~     accident. The emphasis is on dose- and time-specific changes.~      In the course of the study other possible risk factors will be examined including dietary~     iodine intake during and after 1986, and the ingestion of potassium iodide for thyroid~     protection shortly after the accident.~   "
245474|NCT00340574|"~     This study will evaluate the safety and efficacy of the experimental malaria vaccine~     AMA1-C1/Alhydrogel® (Registered Trademark) and determine whether a new, additional component~     of the vaccine may increase its effectiveness. Malaria is a debilitating and potentially~     fatal blood disease transmitted by a parasite found in certain mosquitoes. The AMA1-C1~     vaccine has been designed to create an immune response against the parasite and prevent the~     disease. The purpose of the study is to determine whether the additional component-protein~     pieces known as CpG- improves the immune response to the vaccine without causing problematic~     side effects.~      Volunteers must be healthy adults between 18 and 45 years old. Individuals who have had~     malaria in the past or have recently traveled to areas where malaria is endemic will be~     excluded from the study. Candidates will be screened with a physical examination, blood~     tests, and medical history.~      Participants will be involved in a three-stage study. In the first stage, a group of~     participants will receive either a high dose of the vaccine alone or a low dose combined with~     the CpG protein. In the second stage, a different group of participants will receive a high~     dose of the vaccine alone or a high dose combined with CpG. In the third stage, a larger~     group of participants will receive a high dose of the vaccine alone or a high dose combined~     with CpG. The vaccine will be injected into the muscle of the upper arm, and all participants~     will receive three doses of the vaccine with 28 days between doses to monitor possible~     reactions and side effects. Participants will be monitored for 30 minutes after each~     injection and will record any symptoms they experience over the six days after receiving~     their dose. In addition, participants will be examined over the course of six months during~     and after the trial with physical exams and blood and urine tests.~   "
245582|NCT00339079|"~     This study will compare the effectiveness of cognitive behavioral therapy, antidepressant~     medication, and a combination of the two for treating hypochondriasis.~   "
245436|NCT00341081|"~     This study, conducted at the Johns Hopkins University School of Public Health in Baltimore,~     Maryland, will determine how accurately injection drug users report their needle-sharing~     behavior. Needle-sharing is a major cause of blood-borne diseases, including HIV and~     hepatitis. Therefore, a better understanding of this behavior is critical for devising~     strategies to reduce disease spread in this way. Research on needle-sharing behavior has~     relied heavily on users' self-reports. This study will compare these self-reports with~     results of DNA tests that show whether a needle has been used by one or more individuals.~      Injection drug users 18 years of age or older participating in the Baltimore Needle Exchange~     Program (BNEP) have been recruited for this study. Syringes distributed to users through the~     BNEP are collected after use and tested to differentiate between single versus multiple~     users. The findings are compared with the participants' responses about whether or not they~     shared their needles and syringes.~      Participants visit the clinic every 6 months for an interview, including questions about~     their mental and physical health, drug use, sexual activity and knowledge about HIV (the~     virus that causes AIDS) and AIDS. After the interview, a small amount of blood is drawn for~     testing for HIV, hepatitis, syphilis and other infectious diseases. Some of the blood is~     stored for future testing. Participants return to the clinic 4 weeks after the interview and~     blood drawing to get their test results. At this time, they are offered referral for drug~     treatment, free condoms, advice about drug use and safer sex and an opportunity to ask~     questions about their health. Participation in the study may continue for up to 5 years.~   "
245437|NCT00341068|"~     In a collaborative effort with the Health Research Board, the national organization for~     medical research in the Republic of Ireland, individuals with neural tube defects (NTDs) or~     facial cleft defects and their parents will be studied. With the exception of a few~     well-described syndromes most cases of NTDs and facial clefts are not inherited in a~     Mendelian fashion. Nearly all incident cases occur in families with no prior history of the~     defects. The observed recurrence risk in families with an NTD child is 10-12 fold higher than~     the general population suggesting that inherited factors modify this risk. Historically, the~     incidence of NTDs in Ireland was 5-8 fold higher than the USA. The aim of this study is to~     identify the gene(s) involved in these defects using standard genetic epidemiology~     approaches, transmission disequilibrium testing and gene mapping strategies. We will~     initially evaluate genes known to be involved in folate metabolism and pattern formation~     (development of the body). The major outcomes measured will be aggregate allele frequencies~     in case groups compared to controls. Biochemical parameters in red cells and plasma will also~     be measured. Comparisons will be made between the presence of genetics variants, biochemical~     parameters and clinical phenotype. Characterizing the genes associated with these defects~     should provide insight into the etiology and metabolic processes that may be involved,~     furthering prevention and intervention efforts.~   "
245438|NCT00341055|"~     The purpose of this study is to evaluate the hematologic response, safety, and clinical~     outcomes of PROCRIT administered once a week in anemic cancer patients receiving~     chemotherapy.~   "
245439|NCT00341042|"~     This study, conducted in Bamako, Mali (West Africa), will collect blood and sputum samples to~     establish normal values for laboratory test results among Malians. Researchers are starting a~     new initiative to study HIV and tuberculosis in Africa, using Mali as a model country. In~     order to perform these studies, the scientists need to know what constitutes normal~     laboratory values among the population. People in developing countries may have dramatically~     different laboratory values from those who live in developed countries, and there is~     currently little information available to distinguish normal from abnormal results in~     Malians. This study will establish normal ranges that will provide a basis for future HIV and~     tuberculosis research in Mali. Additionally it will provide blood and sputum samples to~     researchers to study different scientific questions related to HIV and Tuberculosis~     infection.~      Healthy volunteers and people infected with HIV or tuberculosis, or both, who are 18 years of~     age or older and who live in Bamako, Mali, may be eligible for this study. Candidates are~     screened with a medical history, physical examination, and blood test.~      Participants provide a blood or sputum sample, or both, for laboratory analysis. Blood is~     collected through a needle inserted into an arm vein, and sputum is collected by having the~     participant cough deeply and spit in a cup. Participants may agree to provide samples one~     time only or on a returning visit basis. Returning visits may be scheduled daily or weekly.~     Subjects may continue to participate for the duration of the 4-year study, provided their~     medical history and physical examination are updated once a year.~   "
245440|NCT00341029|"~     This study, conducted at Duke University in Durham, NC, will determine whether the drugs~     Adderall and methylphenidate affect the genetic material of children with attention deficit~     hyperactivity disorder (ADHD). One small study has shown that taking methylphenidate for ADHD~     may result in higher levels of certain types of changes to the genetic material contained in~     white blood cells. The changes seen are not directly linked to increased risk of disease, but~     indicate a possibility that other kinds of damage that may be linked to increased disease may~     result from taking methylphenidate. The study will also examine whether these types of~     changes might occur in children treated with Adderall .~      Children between the ages of 6 and 12 with symptoms of ADHD may be eligible for this study.~     Candidates are screened with a medical history, psychiatric examination, IQ test, physical~     examination, and electrocardiogram. Parents and teachers complete questionnaires to rate the~     severity of the child's ADHD. Qualified children who are diagnosed with ADHD and who are~     appropriate candidates for treatment with either Adderall or methylphenidate-based drugs~     (e.g., Concerta, Metadate, Focalin, Ritalin or Ritalin LA) may be selected for this study.~      At a baseline visit (Visit 0), parents complete questionnaires that rate the severity of~     their child's ADHD. The children have their vital signs checked (pulse, blood pressure,~     breathing rate, height, weight and temperature) and have a blood sample drawn. The children~     are then randomly assigned to treatment with either Adderall or a methylphenidate product.~     After the baseline visit, participants undergo the following tests and procedures:~      Dose Optimization Visits (visits 1-4)~      In the first 4 weeks of the study, the dose of methylphenidate or Adderall is adjusted weekly~     until doctors determine the dose strength that works best for the individual child. In~     addition, the following procedures are done at each visit:~        -  Child's vital signs are checked.~        -  Parents complete a questionnaire about the severity of the child's ADHD.~        -  Parent and child describe the impact of symptoms on the child's functioning.~        -  Parents complete forms about common side effects of the study drug.~      Follow-up Visits (visits 5-6)~      Children return to the clinic once a month to assess their health and further adjust their~     medication dose, if needed. The visits are similar to those during the dose optimization~     period, with the following additional procedures at visit 6:~        -  A blood sample is obtained to measure whether the medication has affected the child's~          genetic material.~        -  A physical examination is done to check child's health.~        -  Information is provided parents to assist in planning for child's treatment after the~          study.~   "
245583|NCT00339066|"~     This study will determine the relationship between brain lesion severity, treatment response,~     and frontal lobe brain function in people with late-life depression (LLD).~   "
245584|NCT00339053|"~     The purpose of this study is to determine whether immunonutrition and pre operative nutrition~     can reduce lenght of respirator support, lenght of stay in the ICU and incidence of post~     operative infections~   "
245441|NCT00341016|"~     Leukemia holds a special place in the study of radiation-related cancer because bone marrow~     is one of the tissues most sensitive to the carcinogenic effect of ionizing radiation,~     radiogenic leukemia has the shortest latent period among radiation-induced cancers, and its~     appearance suggests that solid tumors may follow. These same characteristics also contribute~     to its considerable significance in radiation protection. There are, nevertheless, important~     gaps in existing knowledge of radiation-induced leukemia, gaps that derive from~     characteristics of the study of the atomic bombing of Hiroshima and Nagasaki, and from~     studies of the effects of medical irradiation and studies of nuclear workers, these being the~     studies that have provided most of the information to date. These gaps include the presumed~     reduction in risk resulting from dose-fractionation and low dose-rate, and the time-response~     function in the first five years after exposure.~      The primary objective of this study is to investigate leukemia risk as a function of such~     radiation; it would constitute the largest epidemiologic study conducted to date among~     working-age males, a group of particular concern in establishing occupational radiation~     safety standards. In addition, data on cases of multiple myeloma and myelodysplasia~     identified in the cohort will be collected to test the hypothesis of a dose related~     association between radiation and increased risk for each of these diseases.~      The primary scientific objectives of the proposed study are to test the following hypotheses:~     (a) that there is a dose-related increase in risk of leukemia among these liquidators; (b)~     that the magnitude of any observed risk per unit dose is less than that seen in the atomic~     bomb survivors, exposed to essentially instantaneous radiation.~      Subsidiary objectives include: (a) to investigate the nature of the dose-response~     relationship among liquidators and to identify modifiers of risk, including time since~     exposure, age at exposure, etc.; (b) to test the hypothesis that there is a dose-related~     increased risk of multiple myeloma; (c) to test the hypothesis that there is a dose-related~     increased risk of myelodysplasial; (d) to collect and store buccal cells from about 2,000~     liquidators with a wide range of dose estimates extending to well over 1 Gy for possible use~     in future molecular studies of their DNA.~   "
245442|NCT00341003|"~     This study, conducted by the National Center for Malaria Control of Cambodia's Ministry of~     Health, the Guangzhou University of Traditional Chinese Medicine in the People's Republic of~     China, and the U.S. National Institutes of Health, will explore why some people with mild~     malaria progress to a severe form of the disease and why some malaria parasites are resistant~     to treatment.~      Malaria is caused by a parasite that is transmitted to humans through a mosquito bite. It can~     cause fever, aches, and weakness. Left untreated, it can cause severe illness and even death.~     Malaria can be cured when it is treated with effective medicine, but some malaria parasites~     are resistant to medicine.~      Children and adults with malaria symptoms and parasites in their blood will be recruited for~     this study from the Pursat Regional Health Center in Cambodia and the Thai-Cambodian border~     area within Pursat Province.~      Participants are hospitalized for 4 to 6 days at the Pursat Regional Health Center. A small~     blood sample is collected for genetic study and to look for substances in the blood, such as~     certain proteins, that may help protect against severe malaria. Patients are then treated~     with two doses of Artequick(Registered Trademark) (artemisinin-piperaquine), the first dose~     upon arrival at the hospital and the second the next day. (Participants who are pregnant will~     be treated with either quinine or artesunate-mefloquine instead of Artequick.)~      Patients undergo fingersticks several times during their hospital stay to collect a small~     drop of blood to monitor parasite counts. They are discharged from the hospital when their~     symptoms resolve and parasites can no longer be detected in their blood. After discharge,~     patients return to the clinic once a week for 3 weeks for a blood test to monitor for~     parasites, as some parasites may be slightly resistant to the medication. Patients in whom~     symptoms or parasites reappear undergo treatment with artesunate and mefloquine.~   "
245443|NCT00340990|"~     This study, conducted at the University of Mali in the capital city of Bamako, will~     investigate how the body reacts to infection with Mycobacterium tuberculosis (MTB), the~     organism that causes tuberculosis. Tuberculosis is a major global health problem whose~     solution requires development of an effective vaccine. However, incomplete understanding of~     how immunity to MTB is acquired and measured limits vaccine development. This study will~     focus on certain immune system cells - CD4+ T cells - that appear to be very important in~     fighting tuberculosis.~      Individuals 16 years of age and older who have or have not been exposed to either~     tuberculosis or HIV, or both, may be eligible for this study. Candidates will be screened~     with a medical history, physical examination, blood tests, review of medical records and~     laboratory tests, and, if medically indicated, a chest x-ray. Individuals whose medical~     records indicate a past history of tuberculosis or a positive test for exposure to~     tuberculosis will have a tuberculin skin test. For this test, a few drops of fluid are placed~     under the skin to see if the immune system reacts to the substance, indicating previous~     exposure to MTB.~      Participants will come to the University of Mali 10 times over a 1-year period - 7 times~     within the first 3 months of the study and then once every 3 months until 1 year after~     enrollment. At each study visit, they will be asked about their medical history and will~     donate 75 milliliters (about 1/3 cup) of blood, totaling 830 mL over the entire year. More~     blood may be requested if the participant's immune system reacts strongly to MTB in~     laboratory tests. No more than 450 mL (2 cups) of blood would be collected every 6 weeks;~     this amount is the Red Cross limit for regular blood donations every 6 weeks.~      The blood samples will be used for tests that measure the level of immunity to tuberculosis.~     Genetic tests may be performed on blood cells to help interpret special tests of immunity.~     Because HIV-infected people are included in the study, the findings may also provide~     information on how HIV renders vulnerability to opportunistic infections, including~     tuberculosis.~   "
245444|NCT00340977|"~     We propose to conduct a population-based case-control study of facial clefts (cleft lip or~     palate) in Norwegian newborns. Cleft lip and palate are one of the most common type of birth~     defect, and both genetic and environmental causes have been suspected. This project will~     combine tests of recently-discovered genes associated with facial clefting and personal~     interviews of the mothers soon after birth. With this information we expect to be able to~     assess the combined role of genetic susceptibility and environmental exposures in causation~     of facial clefts. We plan to enroll 750 cases and 1100 controls over five years. This will~     provide a 2:1 ratio of controls to cases for the largest sub-category of facial clefts (cleft~     lip with or without cleft palate).~      This study is being conducted as a collaboration between the US National Institute of~     Environmental Health Sciences, and the Norwegian Institute of Public Health/Medical Birth~     Registry. Norway offers a unique opportunity for carrying out such a study. First, all~     Norwegian babies with facial clefts are treated at one of two medical centers at the expense~     of the national government. Our collaboration with these two clinics will provide access to~     virtually every case born in the country. Second, the Medical Birth Registry maintains a file~     of all newborn babies, from which control infants can be randomly drawn from the whole~     population. Random population controls are the gold standard for such studies, but are seldom~     feasible. Third, blood samples from all Norwegian newborns are sent to one laboratory for~     analysis of PKU. Our collaboration with the PKU laboratory will permit mothers of control~     infants to consent to the study of their baby's blood without having to submit their baby to~     an additional needle stick.~      Mothers of cases and controls will be initially contacted through their physicians, and will~     be asked to participate in a telephone interview. With their consent, the mothers will also~     be asked to provide biological samples for analysis of genes that predispose to facial~     clefts. We will collect cheek swabs from control mothers and their infants. Case mothers will~     be asked to provide additional blood samples and cheek swabs for more intensive study of~     genetic factors within their family. Protection of privacy will be paramount. Mothers of case~     infants will be given the option of receiving individual results, but only if a consulting~     panel of ethicists and other experts agree that such information will be beneficial.~      Analysis and presentation of data will be carried out jointly by US and Norwegian~     investigators.~   "
245445|NCT00340964|"~     This study will describe the use of an intervention, developed by an organization called~     Positive Exposure, to improve self-perceptions among adolescents and young adults who may~     encounter the stigma, or negative effect, of differences in their head and face. Photo-shoots~     and video interviews will be used. The combined use of those techniques is a new way to~     address aspects such as self-esteem, body image, and feelings of social awkwardness and~     anxiety-that is, a way that has never been systematically explored with people who have~     craniofacial differences. The conditions that participants in this study have will include~     cleft lip and palate, Apert syndrome, hemifacial microsomia, Treacher Collins syndrome,~     Mobius syndrome and Sturge-Weber syndrome. Among the goals of photography and video~     interviews are to help people to define themselves by their strengths rather than by their~     conditions; visually confront discrimination by others; investigate the possibilities for~     social support, networking, and creative problem-solving that can be developed for people~     with craniofacial conditions; and promote hopefulness for the future. Positive Exposure is a~     nonprofit organization founded in 1997. It investigates the psychosocial experiences of~     people who have genetic, physical, and mental conditions, among all ages and ethnic and~     cultural backgrounds of people. According to experiences of people with several conditions,~     participation with Positive Exposure has enhanced their feelings about themselves as~     attractive, capable individuals.~      Patients ages 12 years and older who have craniofacial conditions may be eligible for this~     pilot study. About 30 people will participate. Participants will be asked to provide the~     diagnosis of their craniofacial conditions. They will also be asked how many surgeries and~     what kinds they have had over the years, and how old they were at the time of the surgeries.~     This information will not be connected to participants' names and will be stored in a~     database protected by password.~      There are three parts to the study. In Part 1, patients will be asked to write a personal~     reflection (for as long as they wish) on their experiences of having their picture taken and~     being video taped. They will also fill out a brief survey, taking about 15 minutes. They are~     able to do this at home and will mail their responses to the researchers. In Part 2, they~     will take part in a photo-shoot (about 1 hour) conducted by the founder and program director~     of Positive Exposure and then take part in a video interview (about 30 minutes) conducted by~     a co-investigator from that organization. In Part 3, to take place 1 month following the~     photo-shoot, participants will write a final reflection that describes their experiences with~     Positive Exposure and then fill out another brief survey (about 10 minutes). Surveys used in~     the study will be the Self-Esteem Scale, Perceived Social Stigma Scale, and State Hope Scale.~     Photo-shoots and video interviews will be held at the studio of Positive Exposure in New York~     City or, if necessary, at a location closer to the participant's home. The projected time~     line of this pilot study is 10 months.~      Direct benefits are not the goal of participation in this study. However, participants may~     enjoy the photo-shoots and video interviews, as well as the process of reflecting and sharing~     their life and photo experiences with others. This pilot study will be a starting point for~     future research into Positive Exposure for adolescents and adults with visible genetic~     conditions.~   "
245446|NCT00340951|"~     This study will evaluate the ability of lung transplant recipients to react to the~     transplanted organs. Previous research indicates that some immune tests can identify whether~     people are at risk for chronic rejection of transplanted lungs. Certain parameters, that is,~     physical properties involving the immune system, may cause acute chronic rejection of the~     lungs, which may lead to chronic rejection, a condition of scarring that worsens lung~     function. If such parameters can be identified and distinguished from those found in healthy~     subjects, information gained can help medical professionals to provide individualized~     treatments that work on the immune system. Short-term and long-term survival of lung~     transplant recipients may thus be improved.~      Patients who will have or have had lung transplants will be recruited by clinical transplant~     coordinators. Normal control subjects will be recruited through flyers and newspaper~     advertisements.~      Collection of blood samples will be done at Duke University Medical Center. Blood collections~     will be done of patients undergoing routine pretransplant and posttransplant blood tests, so~     no extra blood collections will be required. Control subjects will undergo three blood~     collections over an 8-week period. They will be compensated for their time in participating,~     at the rate of $5 for the initial blood draw, $10 for the second one, and $15 for the third~     one. A small amount of blood is involved, about 3 tablespoons. The blood cells and DNA (which~     contains genetic material) will be isolated for analysis. Patients' DNA samples collected~     will be identified by a code, and all other identifying information will be removed. The~     samples may be used in the future as new tests are developed.~      This study will not have a direct benefit for participants. However, during the study, if it~     is found that any patients have an inherited risk for a disease likely to cause early death~     if the disease is not treated, then the researchers will attempt to notify those patients.~     Overall, it is hoped that information gathered will enhance researchers' understanding of~     what tests best identify patients at risk for developing chronic rejection of their~     transplanted lungs.~   "
245447|NCT00340938|"~     This study will test the effectiveness of a practical, low-cost, problem-solving method~     called WE CAN that can be taught to families at diabetes clinics. The goal is to see if this~     teaching and support can help with controlling the level of blood sugar in children with type~     1 diabetes as they approach adolescence. Attention would go to young people's completion of~     tasks necessary to manage diabetes, quality of life, and psychological adjustments, plus the~     role of the family in these situations. Type 1 diabetes mellitus, accounting for less than~     10% of the disease cases, is marked by the inability of the pancreas to secrete insulin.~     People who have it must consistently manage their disease. Successful disease management for~     children depends on the family's adaptation to treatment demands. Yet maintaining acceptable~     blood sugar control becomes more difficult for adolescents, owing to changes in the body~     during that period of life. Also, early adolescence is a vital time in people's development~     of health outcomes. The title WE CAN is a way to remember the steps of the problem-solving~     method:~        -  Work together to set goals~        -  Explore barriers and solutions~        -  Choose the best solutions~        -  Act on your plan~        -  Note the results~      Children who have reached age 9 but are not yet 14.5 years who have had type 1 diabetes for~     at least 1 year and who have had at least two visits to diabetes clinics at one of four~     clinical sites may be eligible for this study. A total of 120 children will participate in~     clinic visits once every 3 months.~      Participants and their families will attend diabetes clinic visits once every 3 months. They~     will be assigned to one of two groups: standard care or WE CAN. Those in the WE CAN group~     will have visits about 15 to 45 minutes longer than those involved in the standard care~     group. All participants will have two home visits: at the beginning and at 6 months. There~     will also be telephone interviews, about 20 minutes long, once every 3 months with the~     children and their parents. Medical data will be collected during each visit to the clinic,~     including blood samples. A health advisor will work with the families. Questionnaires given~     to parents and children separately will measure diabetes-related family conflict, parent~     child sharing of responsibilities for the disease, attitudes and emotions about diabetes, and~     impact of the disease on the child's life. Also, parents and children together will take part~     in a 10-minute discussion of a diabetes-related issue that has caused friction among family~     members. They will discuss the problem, come up with possible solutions, and to try to decide~     on a solution within 10 minutes. Family discussions will be videotaped at the first home~     visit and at the 6-month home visit.~      Families in both groups will receive more detailed monitoring of family diabetes management~     than is usually the case. Those in the WE CAN group may be able to control diabetes more~     effectively during the child's early adolescence, though that result is not guaranteed. If~     the family guidance and support provided by the WE CAN health advisor is effective, children~     in that group may have better results in blood sugar than they would if they did not~     participate in the study. Each family member completing the first and 6-month visits and~     completing each telephone interview will receive payment for participating.~   "
245450|NCT00340886|"~     The Environmental Genome Project (EGP) has completely or partially resequenced the protein~     coding and regulatory regions of 53 environmentally sensitive genes from 72 anonymous~     individuals of varying ethnic backgrounds to date. Some of the same genes have been~     resequenced in an additional set of 20 samples, and, in a subset of these, the introns and~     promoter regions have been sequenced as well. Within this population, 523 allelic variants~     (genetic polymorphisms), mostly single nucleotide polymorphisms (SNPs), have been found to~     date. If the polymorphism alters the behavior or expression of the encoded protein, it might~     be of clinical significance.~      The Office of Clinical Research is planning to establish a large resource bank of frozen DNA~     samples (20,000) and make it available to NIEHS intramural investigators involved in the EGP~     to screen for the presence of these SNPs and other mutations by standard genotyping methods.~     To investigate the feasibility of such a large collection of samples, we plan to first~     conduct a pilot study to estimate the accrual rate and uncover potential problems that may be~     encountered in the larger effort. This IRB proposal is for the pilot study in which we will~     collect whole blood samples (EDTA-anticoagulated) from 481 patients at UNC Medical Center.~     Once the pilot study is complete, we will decide whether to proceed with the larger, 20,000~     sample collection and if so, develop and submit for review a new IRB protocol for its~     implementation taking date from the pilot study into account.~      For both the pilot study and larger, 20,000 sample collection, only blood left over from~     patients already having their blood drawn for hematology (complete blood count or CBC) assays~     as part of their routine clinical management will be used, thus eliminating the need to~     collect extra blood. Once the samples have been obtained from the clinical hematology~     laboratory and processed, they will be identifiable only with a unique identification number~     and sent to an NIEHS contractor (BioServe Biotechnlolgies, Laurel, MD) for DNA isolation.~      During recruitment, interviewers will explain the study to potential participants, obtain~     their signatures on the informed consent documents, and answer any questions they have~     concerning this study. At this time, potential participants will be informed that, depending~     on the results of the genetic analyses of their blood samples, they may be recontacted at a~     later date and asked to participate in follow-up genotype/phenotype studies. These follow-up~     studies will be separate from this protocol and the subjects of future IRB proposals. The~     ultimate objective of these sample collections, combined with the follow-up~     genotype/phenotype studies, is to identify groups of individuals with genetic polymorphisms~     in environmentally sensitive genes, and to correlate their genotype with their clinical~     phenotype, a process known as ascertainment by genotype.~   "
245451|NCT00340873|"~     In 1976 an accidental explosion in a chemical plant 16 miles north of Milan resulted in~     contamination of the local population with 2, 3, 7, 8-terachlorodibenzo-para-dioxin (TCDD).~     There is evidence that TCDD and related phenoxy herbicides act as teratogens, tumor~     promoters, and carcinogens in experimental animals. In human, TCDD causes chloracne in those~     exposed. Associations with various cancers have been reported, but the precise role in human~     toxicity, immune and reproductive dysfunction, and cancer is controversial.~      The Seveso accident provides a unique opportunity for an epidemiological investigation in~     that the exposures are the highest recorded in humans, the exposure involves TCDD without~     other contaminants, and a cohort in the involved and surrounding area has been enumerated.~      There is inter-individual variation in the action of genes involved in TCDD effect in human~     cells. The quality of human AH receptor, and the CYP1A1 and arnt genotypes are examples of~     susceptibility markers that may identify subjects at high risk for TCDD-related disease. A~     hypothesis that could explain the inconsistent association of TCDD exposure with cancer is~     that genetic susceptibility may influence which individuals are adversely affected by TCDD~     exposure.~      The study is proceeding in three phases. The first is a pilot/validation study that is~     complete (field activities) and involved 126 subjects. The second is a case-control study of~     about 100 individuals with chloracne and 100 controls. The field components of phase one and~     two are complete, and analyses of results are underway. The third and final phase is a~     planned case-control study of TCDD-related cancers that will include approximately 125 cases~     and 125 controls.~      The study includes a questionnaire/interview and a biospecimen collection; 73 ml of blood are~     obtained from each participant.~   "
245452|NCT00340860|"~     The Norway Mother and Child study is a collaborative venture among health researchers in~     Norway funded by the Norwegian government. The study is being coordinated by the National~     Institute of Public Health (aka Folkehelsa) in Oslo and the Medical Birth Registry (MBR) in~     Bergen. NIEHS has the unique opportunity to participate through the collection of additional~     tubes of blood during the blood sample collection; these two tubes of blood and a urine~     sample will allow NIEHS and collaborators to explore environmental determinants for disease~     among women and their children. These additional samples will remain in the Biobank in Oslo,~     Norway, with other samples from cohort members and will be used under collaboration with~     Norwegian investigators.~      To achieve better health for mothers and children in the future, the Norway Mother and Child~     study is designed to test specific hypotheses about the causes of a number of serious~     diseases by recruiting 110,000 pregnant women to a cohort study. As part of the primary aim~     of the study, women will be asked to provide a blood sample at 17 weeks gestation, at birth,~     and 4 days after birth. The NIEHS samples will be collected at the blood draw at 17 weeks~     gestation. Likely causal factors will be linked to information obtained from questionnaires,~     blood samples, and medical registers.~      The Norway Mother and Child study has multiple endpoints. Primarily those associated with~     adverse pregnancy outcomes will be studied, but also diseases affecting mother, father or~     child. Endpoints will be taken from questionnaires and medical registers. The study will be~     carried out nationally and any research groups with relevant questions will be able to~     participate. The Norway Mother and Child study has been approved by the Norwegian Parliament~     as well as their Data Inspectorate to ensure that the study and all protocols conform to~     Norwegian ethical standards as well as appropriate research ethical criteria. Further, the~     project has been evaluated by the Regional Ethics Committee for Medical Research which has~     approved all modifications to the project.~      Other researchers, nationally and internationally, will have access to the cohort on request~     and following approval from the project's executive group. NIEHS has the opportunity to add~     additional biological specimens for blood and urine to the base cohort. Two additional tubes~     of blood (total volume 9 ml) and a urine sample will be collected as part of the routine~     prenatal ultrasound visit and blood sample collection included in the overall study protocol.~     As part of a reliability sub-study, blood and urine samples will also be collected an~     additional two times, at weeks 23 and 29 of gestation. These samples are designed to allow~     investigators to explore environmental contributors to the health of women and their~     children. Low level exposure to environmental contaminants occurs in all industrialized~     countries, though the level of exposure may differ as the result of diet, cooking practices~     and pollution sources. However, the ability to explore the role of environmental exposure on~     health is often more limited by good population-based information on health and disease then~     by exposure level. Thus, by creating a biological specimen repository in a country with~     excellent disease registries, it will allow NIEHS to explore risk factors for disease~     relevant to US populations. All samples will be stored in Norway and will be used in~     collaboration with Norwegian and other investigators. NIEHS investigators will not have~     access to identifying information. NIEHS samples will not be used for genetic analyses.~   "
245453|NCT00340847|"~     The proposed research intends to construct a set of tissue microarrays containing different~     types of normal and lung cancer tissues for the study of genes associated with lung cancer.~     Thus far we have generated a lung cancer tissue arrayusing paraffin embedded archival tissues~     from 300 lung turmors tissues and 100 adjacent normal tissues. Four- micrometer thickness~     sections have been cut from the tissue array and were used to survey gene expression status~     in arrayed tumors using immunohistochemistry methody. We are currently performing IHC studies~     ot 1) determine protein expression and its correlation with gene expression patterms ovserved~     using cDNA arrays. 2) Analyze protein expression in the chromosome remodeling pathyway in~     non-small cell lung cancer. And 3) determine the association of gene expression with lung~     tumor stage and clinical outcome. The current protocol is needed to complete the above~     studies and for the production of neuroendocrine tumors.~   "
245454|NCT00340834|"~     This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod~     versus interferon β-1a to reduce the frequency of relapses in patients with~     relapsing-remitting multiple sclerosis.~   "
245455|NCT00340821|"~     Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the~     National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the~     etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell~     lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL~     and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy~     also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of~     infective dermatitis cases was recently added and the disease entity is thought to be a~     harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to~     interview patients with these conditions and perform laboratory studies (specifically, HLA~     and other viral or genetic studies) to better understand these diseases and their~     relationship to the HTLV-1 virus and the family history and genetic factors that may be~     involved as well.~   "
245456|NCT00340808|"~     This study, sponsored by NCI and the Gynecologic Oncology Group (GOG), will collect tissue~     samples from women with cancer of the endometrium (lining of the uterus). Researchers will~     use the samples to learn more about endometrial cancer and develop new treatments and methods~     of prevention.~      Women with endometrial cancer who are suitable candidates for surgery and who have not had~     prior retroperitoneal surgery or pelvic or abdominal radiation therapy may be eligible for~     this study. Candidates will be screened with a medical history and physical examination,~     blood tests, and endometrial biopsy (surgical removal of a small tissue sample) or dilation~     and curettage (D & C).~      Participants will undergo hysterectomy (surgery to remove the uterus) along with removal of~     both fallopian tubes and ovaries. This is the standard surgical treatment for endometrial~     cancer. Lymph nodes in the pelvis near the main blood vessel in the abdomen are also removed~     to determine if the disease has spread to these nodes. If cancer is found involving other~     sites, the cancer in those areas may also be removed; examination of the tissues will~     determine if further therapy beyond surgery is needed.~      Before surgery, patients will complete a 20-minute questionnaire that includes questions~     about their background, reproductive history, menstruation and menopause, certain surgeries,~     birth control pills and hormone replacement therapy, other drugs and medicines, weight and~     height, smoking, medical history, and family history of cancer.~      Some of the tissue removed during surgery, plus a urine sample collected from a catheter bag~     during surgery, and blood drawn before surgery and at follow-up visits 6 weeks and 3 years~     after surgery, will be sent to the GOG Tissue Bank in Columbus, Ohio. This bank stores,~     processes, and distributes biological specimens from patients that agree to participate in~     studies conducted by the GOG.~      Patients will have follow-up visits 6 weeks after surgery, then every 6 months for the next 2~     years, followed annually for the next 7 years, for a total 10-year follow-up. The visits will~     include an examination and questions about health status and treatments received between~     visits. Patients whose cancer returns or worsens will undergo another tumor biopsy, if~     possible, at that time.~   "
245585|NCT00339040|"~     The purpose of this study is to determine the safety of and immune response to a new human~     papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between~     the ages of 7 and 12 years.~   "
245457|NCT00340795|"~     This study will evaluate the impact of a Media-Smart Youth (MSY) curriculum on adolescent~     knowledge and behavioral intent regarding media messages, nutrition, and physical activity.~     The study is part of the U.S. Government's efforts to fight obesity and increase physical~     activity among American youth. The MSY program seeks to empower adolescents to make healthful~     choices about nutrition and physical activity by helping them understand how media can~     influence their lives. This is important because it is estimated that young people view as~     many as 40,000 commercial messages a year on television alone, many of which promote~     unhealthy snack foods and beverages.~      Youth between 11 and 13 years of age who are participating in selected after-school programs~     in the Washington, D.C., metropolitan area may be eligible for this study.~      Participants are randomly assigned to either receive the MSY curriculum or serve as controls.~     Youth in the MSY group participate in a workshop consisting of 10 lessons and a creative~     project to create a media message for their peers on the topic of nutrition and physical~     activity. During the sessions, the young people receive information on nutrition and physical~     activity and learn about media production and how to critically examine the media. Youth in~     the control group participate in after-school programs unrelated to MSY. All participants~     fill out questionnaires measuring their knowledge, skills, and behavioral intent related to~     media analysis, nutrition and physical activity both at the start of the study and at its~     completion.~   "
245458|NCT00340782|"~     This study will explore the influence of social and environmental factors, such as stress,~     nutrition, health status, etc., on women's reproductive function.~      Married Mayan women 16-42 years of age who live in the rural highlands of Guatemala and who~     have given birth to at least one child are eligible to participate in this study.~      Participants are interviewed about their demographic, social, family, personal, health,~     reproductive and economic situations. They have saliva and urine samples collected three~     times a week for up to 1 year. Their nutritional and health status is assessed monthly.~   "
245459|NCT00340769|"~     The CCCH tandem zinc finger proteins are members of a small family of proteins that regulate~     the stability of certain types of mRNA containing so-called class II AU-rich elements in~     their 3'-untranslated regions. The best studied member of this protein family,~     tristetraprolin (TTP), exerts this destabilizing effect on at least two mRNAs coding for~     physiologically and medically important cytokines, tumor necrosis factor alpha and~     granulocyte macrophage colony stimulating factor. The physiological functions of the other~     two members of this protein family in mammals, 11B and 11D, are not known, but in~     experimental transfection studies they too can destabilize mRNAs containing this type of~     AU-rich element.~      As part of the Environmental Genome Project, we resequenced the protein coding portions of~     the human genes encoding these three proteins, and uncovered a dinucleotide splice site~     mutation in the 11B gene in one of 144 alleles sequenced. We showed that this mutation~     created a novel restriction fragment length polymorphism, and that this mutation resulted in~     the failure of splicing and expression of the mRNA encoded by the mutant allele. Based on our~     previous data with mice completely deficient in TTP, we anticipate that complete deficiency~     of this protein, and possibly its partial deficiency, would result in human disease.~      The mutant allele was from an anonymous adult Aka Pygmy women from the Central African~     Republic. We propose to genotype up to 1000 members of this ethnic group after obtaining~     buccal cell DNA from them. This will give us an approximate idea of the prevalence of this~     mutation in this population. If the mutation is found in a significant number of living~     individuals in this initial screen, then we will propose a later study of the individuals who~     have this genotype and their families. This second study, which will be reviewed separately,~     will attempt to correlate this genotype with a human trait or phenotype and possible y~     treatable human disease.~   "
245460|NCT00340756|"~     The purpose of this study is to evaluate the reproducibility of measurements of sex hormone~     levels in serum samples. Researchers will collect blood from 60 healthy adults, including 20~     men, 20 premenopausal women, and 20 postmenopausal women. Blood samples will be collected~     after study participants have fasted overnight.~   "
245461|NCT00340743|"~     This study will examine the risks and protective effects of dietary factors on temporary~     genetic damage to cells lining the gastrointestinal tract and to blood cells. Some foods,~     including very well done meat, may increase genetic damage in cells, while others, such as~     yogurt and vegetables, may reduce genetic damage. This study may provide new information on~     the influence of diet on increasing or decreasing the risk of developing cancer, particularly~     colorectal cancer. The study is conducted at the General Clinical Research Center (GCRC) of~     the University of North Carolina.~      Nonsmoking, English-speaking, healthy adults between 18 and 45 years of age may be eligible~     for this 4-week study. Participants undergo the following tests and procedures:~        -  Interview: Participants complete questionnaires including information on their diets,~          habits, past and present health, and family histories.~        -  Diet: Participants adhere strictly to the diet provided by the dietician at the GCRC for~          all 4 weeks of the study. All meals are provided by the GCRC. All meals contain~          well-done meat and some contain yogurt, cruciferous vegetables, including broccoli and~          cabbage, and chlorophyllin tablets. Chlorophyllin is a compound in some foods that~          protects against genetic damage.~        -  Urine sampling: Participants collect a urine sample each morning except Saturday and~          Sunday.~        -  Stool sampling: Participants collect two stool samples during the study, one during the~          second week and another during the fourth week.~        -  Blood draw: About 2-1/2 tablespoons of blood are drawn once a week for research~          purposes. The blood is tested for the effects of eating foods in the different diets~          used in the study.~        -  Rectal biopsies: Four pinch biopsies, each about the size of a grain of rice, are taken~          from the rectum once a week for research purposes. For this procedure, forceps are~          inserted shallowly into the rectum to collect the tissue. The effects of the different~          diets on the colon cells are measured.~   "
245462|NCT00340730|"~     America's greatest resource is its youth, but that resource is increasingly threatened by~     violence. Recommendations for violence prevention have highlighted the need to focus on youth~     and to explore targeted interventions Nowhere is the need greater than in our nation's~     capital where the intentional injury fatality rate for youth age 14-19 is higher than any of~     the 50 states. This study builds on the CDC-supported project Adolescent Violence: A~     Community-Based Strategy which instituted citywide surveillance on injuries, conducted by~     researchers at the Children's National Medical Center. In this study, the same researchers~     will extend that work by testing an individualized intervention to reduce violent behavior~     among a sample of assault-injured youth, age 9-15, who present at the Emergency department~     (ED). 196 youths and their families will be included in this randomized trial, with 98~     families assigned to the individualized intervention condition and 98 families assigned to~     the control condition. Families will be followed for 18 months. To address issues of~     attrition over the 18 months that the study follows, approximately twice as many families, or~     400 families, will be recruited to participate in the study.~   "
245586|NCT00339027|"~     HealthSpark is a community-based research network of childcare centers designed to improve~     the health of children in Miami-Dade County. HealthSpark is the health component of SPARK~     (Supporting Partnerships to Assure Ready Kids), a community coalition led by the Early~     Childhood Initiative Foundation to improve school readiness in Allapattah/Model City and~     Homestead/Florida City, two underserved Miami-Dade County communities. The goal of~     HealthSpark I is to identify the health and healthcare needs of preschool children, then help~     translate evidence-based intervention into community programs.~   "
245463|NCT00340717|"~     This study will determine whether certain gene alterations can serve as markers for early~     detection of prostate cancer. Prostate cancer is often diagnosed by detecting high levels of~     a protein called prostate-specific antigen (PSA) in the blood. Other conditions can also~     cause elevated PSA levels, however, so that additional tests are needed to distinguish~     between benign and cancerous prostate conditions.~      Patients between 40 and 75 years of age who are referred to Howard University Hospital in~     Washington, D.C., or Madigan Army Medical Center in Tacoma, Washington, for ultrasound and~     needle biopsy to diagnose prostate cancer may be eligible for this study.~      Participants will undergo the following procedures at the time of the biopsy visit:~        -  Blood collection: Patients have 10 milliliters (2 teaspoons) of blood drawn.~        -  Prostate massage: Patients have a rectal examination and prostate massage. For the~          latter procedure, the physician lightly massages the prostate gland for about 15~          seconds. After the massage, the patient provides a urine specimen.~        -  Biopsy: A small sample of tumor tissue is removed surgically for examination under the~          microscope.~      Patients whose initial biopsy does not show cancer cells, but who are advised to have a~     repeat biopsy in the future will give a blood, urine, and biopsy specimen at the time of the~     next biopsy.~      Patients who are diagnosed with prostate cancer and undergo surgery to remove the tumor will~     have a small sample of tumor tissue set aside for this study to look for substances that may~     help predict prostate cancer.~   "
245464|NCT00340704|"~     Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and~     evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in~     children with a neuropathic bladder, over the course of 12 months of active treatment.~   "
245465|NCT00340691|"~     This study will examine: 1) the safety and effectiveness of the drug doxycycline in reducing~     the number of Mansonella perstans (Mp) worms in the blood of infected patients, and 2) the~     effects of doxycycline followed by albendazole and ivermectin treatment for lymphatic~     filariasis, caused by the parasitic worm Wuchereria bancofti (Wb).~      Both Mp and Wb very small filarial worms that are spread by mosquitoes. Some people are~     infected with both Mp and Wb. Although most people do not become ill from infection with~     these parasites, some develop symptoms. Wb can cause swellings in the arms, legs, breast, and~     scrotum, and can progress to permanent swelling of the legs or arms called elephantiasis. Mp~     can cause itching, swelling, fever, headache, or other symptoms. Ivermectin and albendazole~     are medicines used to treat lymphatic filariasis. They eliminate the Wb parasite from the~     blood but do not affect Mp. Doxycycline is used to treat many kinds of infections and has~     also recently been shown to reduce the number of filarial worms in several types of filarial~     infections. The drug may be useful in Mp infections as well.~      Residents of Sabougou and nearby villages in Mali who are infected with the Mp parasite, are~     between 14 and 65 years of age, are in good health, are not pregnant or breastfeeding, and~     weigh at least 40 kg (88 lb) may be eligible for this study. They may or may not also be~     infected with Wb. Candidates are screened with a brief medical history and physical~     examination and blood tests to look for infection with Mp and Wb.~      Participants undergo a complete physical examination and medical history. Blood is drawn for~     routine blood tests. Participants are then randomly assigned to one of four treatment groups,~     as follows: 1) doxycycline for 6 weeks; 2) doxycycline for 6 weeks followed by a single dose~     of albendazole and ivermectin given 6 months after the beginning of doxycycline treatment; 3)~     a single dose of albendazole and ivermectin given 6 months after the beginning of doxycycline~     treatment; or 4) no treatment. Only patients infected with Wb receive albendazole and~     ivermectin treatment.~      All participants, whether or not they receive doxycycline, come to the clinic every day for 6~     weeks. Every 2 weeks during this time, they have a blood test and, in women of childbearing~     age, a urine pregnancy test. After 6 months, they have a medical history, physical~     examination, and blood tests. Subjects in the albendazole/ivermectin treatment group are~     given the pills to take at that time. One year and three years after beginning the study,~     participants return to the clinic for a final history, physical examination, and blood tests.~      At the end of the first year of the study, all participants who tested positive for lymphatic~     filariasis but did not receive ivermectin and albendazole will be offered treatment with~     these medicines Ivermectin and albendazole will also be distributed by the Mali government to~     everyone in the villages as part of a program to eliminate lymphatic filariasis in the~     country.~   "
245466|NCT00340678|"~     This investigation is a randomized, double-blinded, placebo-controlled clinical trial in~     adult diabetic Pima Indians with normal urinary albumin excretion (albumin-to-creatinine~     ration less than 30 mg/g) or microalbuminuria (albumin-to-creatinine ration = 30-299 mg/g) to~     test the hypothesis that blockade of the renin-angiotensin system with the angiotensin~     receptor blocker (ARB) losartan can prevent or further attenuate the development and~     progression of early diabetic nephropathy in subjects with type 2 diabetes mellitus who are~     receiving standard diabetes care.~      One hundred seventy subjects were recruited for the study, all of whom had type 2 diabetes~     for at least 5 years, serum creatinine concentrations less than 1.4 mg/dl, and no evidence of~     non-diabetic renal diseases. Ninety-two of the subjects had normal urinary albumin excretion~     at baseline and other 78 had microalbuminuria. Subjects in each albumin excretion group were~     randomized to treatment with either the angiotensin II receptor antagonist, losartan, or~     placebo. Measurements of glomerular filtration rate (GFR), renal plasma flow (RPF) and~     fractional clearances of albumin and IgG will be made initially, at one month, and at~     12-month intervals from baseline thereafter. A kidney biopsy was performed after six years in~     111 subjects. Morphometric analysis of renal biopsies was used to determine differences in~     glomerular structure between treatment groups.~   "
245467|NCT00340665|"~     This study, conducted at the University of Pennsylvania s Newborn Nursery, the Children s~     Hospital of Philadelphia, and the Exton Specialty Care Center, will examine how different~     infant diets may affect estrogen activity in babies. During pregnancy, babies are exposed to~     the female hormone estrogen from their mother. Estrogen plays a key role in the development~     of breasts and milk production, as well as the development of the uterus. The effects of~     these hormones can be seen when babies are examined. Between 6 and 12 months of age, the~     effects are reduced. Breast milk and some infant formulas may contain compounds that can act~     like female hormones in the body and may prolong the estrogen effects.~      This study has two parts. Part 1 studies the physical development of babies fed different~     ways. Part 2 studies how hormone levels in babies differ depending on what they are being~     fed. Babies may participate in one or both parts. Part 1 includes babies 0 to 6 months of~     age; part 2 includes babies 0 to 12 months of age. In each part of the study, parents may~     choose to have their babies evaluated from one to four times.~      Full-term infants (age 37 to 41 weeks gestational age) from birth to 12 months of age who~     weigh from 2501 to 4499 grams (about 5.5 to 10 pounds) at birth and who have no chromosomal~     abnormalities, major malformations, or endocrine problems may be eligible for this study.~     Male infants must have palpable testes. Infants being fed a diet of breast milk, soy milk, or~     cow s milk will be included. Study procedures include the following:~      Part 1~        -  Feeding history: the parent provides information about the baby s dietary intake since~          birth.~        -  Length, weight, and head circumference: the baby s measurements are taken.~        -  Physical examination: the baby s physical maturity is assessed by examination of the~          skin, breasts, and external sex organs.~        -  Breast secretions: the baby s breast buds are gently pressed during the physical~          examination to look for a milky-white substance that some babies produce during the~          first year of life. If the substance appears, a specimen will be collected.~        -  Vaginal cells: for baby girls, the opening of the vaginal area is gently swabbed with a~          sterile Q-tip to assess the maturity of the vaginal lining.~      Part 2~        -  Feeding history and length, weight and head circumference measurements as described~          above.~        -  Urine: a urine sample is collected in a cotton diaper or a urine collection bag.~        -  aliva: a saliva sample is collected by gently swabbing the inside of the baby s mouth 1~          hour after a morning feeding to remove any left over milk.~        -  Hair: a lock of hair, 1/2-inch wide and 1 to 2 inches long is taken from 12-month old~          babies.~        -  Blood: some infants have a small blood sample collected by a heel-stick.~      This study will serve as a basis for a later study about how infant formulas affect infant~     growth.~   "
245596|NCT00338897|"~     The primary objective is to:~        -  demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE)~          by the demonstration of a dose-response in patients undergoing total hip replacement~          surgery.~      The secondary objectives are to:~        -  evaluate the safety of SR123781A in the prevention of VTE after elective total hip~          replacement surgery; and~        -  to assess the SR123781A pharmacokinetic profile in patients undergoing elective total~          hip replacement surgery.~   "
245468|NCT00340652|"~     This study, conducted at the Children's Hospital of Boston and the Brigham and Women's~     Hospital in Boston, will examine the natural history of infant development in the first year~     of life and how different types of infant feeding may affect that development. During~     pregnancy, babies are exposed to the female hormone estrogen from their mothers. Estrogen~     affects development of breasts and milk production, as well as the development of the uterus,~     ovaries and possibly other hormonally responsive organs in both males and females. Between 6~     and 12 months of age, the effects are reduced. Breast milk and some infant formulas may~     contain compounds that can act like female hormones in the body and may prolong the estrogen~     effects. This study will examine the natural history of estrogen activity in infants on~     different feeding regimens, breast milk, cow's milk, and soy milk and will serve as~     preparation for a larger study of the effects of soy formula on estrogen activity in infants.~      Full-term female babies (37 to 41 weeks gestational age at birth) from 0 to 12 months of age~     and male babies from birth to 6 months of age who weigh from 2501 to 4499 grams (about 5.5 to~     10 pounds) at birth and who have no chromosomal abnormalities, major malformations, or~     endocrine problems may be eligible for this study. Males must have palpable testes. Babies~     being fed a diet of breast milk, soy milk, or cow's milk will be included. Study procedures~     include the following:~        -  History of the baby's dietary intake since birth, provided by the parent;~        -  Ultrasound measurement of the uterus, ovaries, and breasts in female babies; the testes,~          prostate, and breasts in males; and the thymus, thyroid, and kidneys in all babies;~        -  Measurements of all babies' weight, length, and head circumference.~   "
245469|NCT00340639|"~     This 1-year study will explore the influences of family and peers on how diabetic adolescents~     manage their disease, focusing on adolescent developmental transitions. The management of~     diabetes is a complex process involving daily self-care activities, problem-solving, and~     decision-making. It is particularly challenging during adolescence when youth are~     experiencing physiological, social and psychological changes, and coming under increasing~     peer influence and decreasing parental supervision. Although it is expected that the~     responsibility for diabetes management will gradually shift from the parent to the child~     during adolescence, research indicates that many children may be given responsibility for~     managing their illness too early, without adequate parental monitoring. Specifically, this~     study will examine the following issues:~        -  The relationship of peers, parents and school support to successful diabetes management;~        -  The influence of the adolescent's self-image and personal goals on diabetes management;~        -  The influence of the adolescent's and parents' attitudes, capability and environment on~          the balance of responsibility for diabetes management.~      Children between 10 and 16 years of age receiving treatment for diabetes type 1 at Georgetown~     University Medical Center's pediatric diabetes clinic may be eligible for this study. The~     children must have been diagnosed with diabetes at least 1 year before entering the study and~     must require insulin treatment. One parent of each child will also participate in the study.~      Children and their parents will complete the following procedures:~      Home Interviews: Parents and children will complete two at-home face-to-face interviews 6~     months apart. At each interview, children will answer questions about their responsibility~     for and adherence to their diabetes management, treatment outcome expectations, optimism,~     self-esteem, self-consciousness, personal goals, social support, perceived barriers to~     diabetes management, family routine and family conflict, their parents' involvement in their~     diabetes management, and parenting style. Parents will evaluate their child's ability to~     manage his or her diabetes, level of maturity, self-esteem, and transition of responsibility;~     their family routine and family conflict, parent-child communication, their parenting goals,~     and their involvement in and responsibility for their child's diabetes management. Three days~     after the 6-month interview, a randomly selected group of parents and children will complete~     a brief, additional telephone interview covering some of the same issues.~      Telephone Interview: At 12 months, parents and children will complete a telephone interview~     that will include questions about adherence to diabetes management and the responsibility of~     parents and children for diabetes management.~   "
245470|NCT00340626|"~     In a collaborative effort with the IBN AL-NAFEES Hospital (Damascus, Syrian Arab Republic),~     individuals from multiplex families determined to have hereditary oral clefts will be~     studied. The purpose of this study is to identify the gene(s) involved in heritable oral~     clefts by linkage analysis and gene mapping strategies. Characterization of genes involved in~     inherited oral clefts could provide important insight into the inheritance and pathogenesis~     of this disease.~   "
245471|NCT00340613|"~     We hypothesize that checking blood sugar and taking long and short acting insulin before~     lunch at school may improve overall blood sugar control, grades, and decreases school~     absences in children and teens with poorly controlled T1DM.~   "
245472|NCT00340600|"~     Diethylstilbestrol (DES), a drug first synthesized in 1938, was administered to several~     million pregnant women in the U.S. and Europe for the prevention of spontaneous abortion and~     premature delivery. In 1971, Herbst reported a strong association between DES use in~     pregnancy and the occurrence of vaginal clear cell adenocarcinoma (CCA) in exposed female~     offspring. Animal models have demonstrated a range of DES effects on offspring exposed in~     utero, including reproductive dysfunction, immune system changes, behavioral and sexual~     abnormalities, and increases in various reproductive cancers in males and females. In the~     mid-1970's, several separate cohorts of DES-exposed daughters and unexposed comparison groups~     were followed for the occurrence of cancer, precursor lesions, and reproductive effects, but~     systematic follow-up of these cohorts had ceased by 1990. In 1992, Congress passed a bill~     (H;.R. 4178) mandating the continued follow-up of DES-exposed cohorts. The National Cancer~     Institute, in collaboration with five field centers, reassembled previously studied cohorts~     of DES-exposed and unexposed mothers, daughters and sons, and identified subjects with~     documented exposure status who had not been studied previously, through familial links within~     the cohorts. Standardized baseline questionnaires were mailed to cohort members to ascertain~     the risk of cancer and other disorders. Pathology reports were collected for reported cancers~     and preneoplastic conditions. Two separate rounds of follow up have been conducted and a~     third is almost complete. Patients from the Registry for Research on Hormonal Transplacental~     Carcinogenesis (the Registry) will be added to the follow-up effort in the third phase. The~     purpose of this study is to continue the follow-up, by means of mail questionnaires and~     medical record collection, which was begun during the first phase of the study. Concern has~     arisen that DES-exposed daughters may be at higher risk of breast cancer. Exposure to high~     levels of endogenous estrogen in utero has been hypothesized to increase the risk of breast~     cancer and DES is a potent estrogen. Cancer risk in the sons will also continue to be~     assessed, especially for increased risks of prostate cancer. Since the offspring who were~     exposed to DES in utero are currently reaching their late forties, when cancer rates begin to~     rise, it is important to continue the follow-up of these cohorts to determine if there are~     long-term increases in cancer risk....~   "
245473|NCT00340587|"~     At fertilization, the binding of sperm to the zona pellucida induces the acrosome reaction~     releasing lytic enzymes that facilitate the passage of the sperm through the zona. The sperm~     then fuses with the egg's plasm membrane and enters the egg's cytoplasm. The zona pellucida,~     an extracellular matrix composed of three glycoproteins (ZP1, ZP2, ZP3), mediates the~     species-specific binding of sperm to egg. Although homologous proteins are present in mouse~     and humans, human sperm will not bind to the mouse zona pellucida and when the zona pellucida~     is experimentally removed, human sperm will not bind or fuse to the mouse egg's plasm~     membrane. We have created transgenic mouse lines that express one or more human zona~     proteins. We wish to determine if human sperm will bind to these chimeric zonae and if this~     binding will induce the human sperm acrosome reaction. Sperm and devitalized eggs will be~     collected by collaborating institution(s) under protocols and consent forms approved by that~     institution's IRB. Only procedures already being performed on subjects for diagnostic or~     treatment purposes will be used.~   "
245597|NCT00338884|"~     A phase II study to allow patients with advanced kidney cancer access to sunitinib malate~     treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a~     continuous daily regimen (once per day) for one year.~   "
245598|NCT00338871|"~     The purpose of this study is to examine whether simple home-base aerobic exercise program~     have beneficial effect on walking abilities and balance performance in children with brain~     damage~   "
245475|NCT00340561|"~     This study will evaluate the driving performance of new teenage drivers and determine to what~     extent independent driving experience improves driving performance of young drivers. Motor~     vehicle crash rates are highest among new teen drivers, especially during the first 6 months~     and 1,000 miles of independent licensed driving. Crash rates decline with experience, and~     this study will assess the effect of driving experience on performance.~      Newly licensed teenagers ranging from 16 years, 3 months to 17 years of age and experienced~     drivers 30 to 50 years of age may be eligible for this study. Candidates must be able to~     legally drive in the commonwealth of Virginia and have at least 20/40 correctable vision.~      Participants complete a questionnaire about their health and driving experience. They are~     then tested on a driving test track. Teens are tested within 3 weeks of obtaining their~     driver's license and before they have more than 100 miles of independent driving experience.~     They are tested a second time 6 to 12 months later and after they have more than 1,000 miles~     of driving experience. A group of experienced adult drivers are also tested to provide a~     comparison.~      The driving test is conducted on a smart road - a controlled, 2.2-mile two-lane research~     track at the Virginia Tech Transportation Institute. It is designed for safety, with~     restricted access, nothing for a vehicle to hit, carefully placed guardrails, and other~     safety features. The research vehicle is equipped with airbags, anti-lock brakes, and other~     safety equipment. It also has sensors and tiny video cameras to assess the behavior of the~     vehicle and the driver; this equipment does not interfere with the operation of the vehicle.~      An experimenter accompanies the driver and instructs him or her to perform routine driving~     skills, such as stopping, changing lanes and maintaining speed, as well as to other tasks~     such as inserting a CD into an entertainment console, having a conversation, and answering a~     cellular telephone call. The driver has an opportunity to practice the tasks before being~     tested.~      The driver's speed is limited to 35 mph or less during the experiment and the driver is~     required to wear seat belts and follow safe driving procedures. The experimenter is in the~     front passenger seat can stop the vehicle using a separate brake pedal.~   "
245476|NCT00340548|"~     Background:~      Over 80% of the hemophiliac population who became infected with HIV prior to 1985 are also~     co-infected with HCV. Thus, hemophiliacs represent an important population for studies of the~     natural history of these chronic viral infections.~      Moreover, the high rate of co-infection makes it an ideal group for assessing the interaction~     between the viruses and the relationship between viral specific immune responses and clinical~     progression.~      Although the hemophiliac poulation is unique, co-infection by these chronic viral pathogens~     is becoming increasingly common, particularly amongst intravenous drug users, who account for~     approximately 25% of the HIV-1 epidemic in the United States.~      Objectives:~      The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2~     cytokines are associated with (1) intracellular cytokines levels in CD4 + Tcells, (2) Human~     Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) viral loads, and (3) clinical~     progression of HIV1 to AIDS in hemophiliacs.~      Eligibility:~      The current proposal will investigate host genetic factors related to HIV-1 and HCV~     immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and~     Development Study (HGDS).~      Design:~      This study is in collaboration with the principle investigators of the Hemophilia Growth and~     Development Study (HGDS) as part of a grant Pathogenesis of HIV and HCV in Hemophilia:~     HGDS-3 with funding support by NIH/NICHD for the period 9/25/01 through 8/31/2005.~      This multicenter, United States study represents a well-characterized, prospectively followed~     cohort of HCV-infected hemophiliacs, of whom 207 are HIV-1 co-infected.~      Enrollment of the hemophiliac cohort was completed between 3/89 and 6/90. The final~     observation of the cohort (follow-up 16) was concluded during 7/98. No new samples or~     clinical data will be collected on this population.~      The LGD plays two roles in this project: (1) an administrative role overseeing the~     withdrawal, handling, and transport of samples from the HGDS/LGD and central repositories at~     the NCI-Frederick, and (2) a scientific role continuing investigations to determine the role~     of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral~     replication..~   "
245477|NCT00340535|"~     This study will examine whether genetic differences among individuals affect blood levels of~     certain chemicals called DBPs after showering. Chemicals such as chlorine and ozone are used~     to kill germs in water. These chemicals may react with organic matter in the water and form~     other chemicals called disinfection byproducts, or DBPs. Although people are usually exposed~     to DBPs by drinking tap water, these chemicals may also penetrate the body during showering.~     This study will see whether the levels of DBPs after showering vary among individuals~     depending on differences in genes that code for enzymes called GSTT1, CYP2D6, and CYP2E1,~     which break down DBPs. This study, sponsored by the Centers for Disease Control and~     Prevention and the National Institutes of Health, is conducted at the University of~     Pittsburgh's Center for Clinical Pharmacology.~      Healthy adults between 18 and 45 years of age who do not smoke cigarettes and are not taking~     any medicines may be eligible for this study. Candidates are screened with a medical history~     and blood and urine tests. Participants are given a diary to record the foods they eat and~     how much water they drink during the 2 days before their study appointment. The following~     activities are scheduled on the appointment day:~        -  Measurements of blood pressure, height, and weight, and pregnancy test for women~        -  Questions about alcohol consumed and medications taken in the last 48 hours~        -  Review of food and water diary~        -  Interview for demographic information (name, address, date of birth, etc.) and other~          information, such as sex, height, weight. Subjects are also asked about anything, such~          as exercise, that might affect their breathing, since breathing problems are a rare side~          effect of chlorzoxazone, a drug used in this study.~        -  Urine sample collection~        -  Blood draw and insertion of a small catheter (plastic tube) to allow for additional~          blood draws during the test procedure without having repeated needle sticks~        -  10-minute shower in a private bathroom~        -  Blood sample collection 10 minutes after the shower and again at 30 minutes after the~          shower~        -  Dose of chlorzoxazone (a drug used to treat muscle pain)~        -  Interview about subject's exposure to water~        -  Light breakfast~        -  Blood and urine collections 2 hours after the chlorzoxazone dose~        -  Lunch~        -  Observation for drug side effects for 2 hours, or longer if needed~      Seven blood samples totaling 75 milliliters (about 5 tablespoonfuls) of blood are collected~     during this study. The blood is tested for chemicals called trihalomethanes to see how they~     are broken down. The urine samples are tested for chemicals called haloacetic acids, which~     are found in tap water after it has been treated with chlorine.~   "
245478|NCT00340522|"~     This study will construct tissue microarrays (TMAs) pertaining to childhood cancer. TMA~     technology is a recently developed one that allows for evaluating hundreds of tissue samples~     simultaneously on the DNA, RNA, and protein levels. The goal is to identify a potential~     molecular signature. Cancer drug discovery is currently focused on identifying drugs targeted~     at the molecular level. Such drugs would be more selective and specific for proteins and~     signaling pathways that are directly involved in the origin of tumors. However, the origin of~     cancer among adults differs from that of cancer diagnosed in children. The overall approach~     by the pharmaceutical industry in developing drugs is not likely to be aimed at low-incidence~     cancers, such as childhood cancers. Thus, the researchers in this study propose to create a~     childhood cancer TMA that include specimens from a wide range of solid tumors that present a~     poor prognosis for patients. This TMA would in turn be used to identify antibodies and lead~     to developing molecularly targeted drugs that would reach clinical trials in adults.~      TMAs are created robotically. Small tissue cores are taken from paraffin-embedded tissue~     blocks and are implanted into new paraffin blocks. The recipient blocks are then processed to~     produce several hundred specimens that can be evaluated on a single glass slide. Specimens~     representing 17 distinct kinds of pediatric solid tumors will be used in this study. Also~     included will be samples of plexiform neurofibroma-that is, benign growths of nervous and~     connective tissues.~      Tissue specimens will come from patients who were age 25 or younger at the time of diagnosis~     of their cancer or plexiform neurofibroma. No procedures will be performed for the sole~     purpose of obtaining tissue for this study.~      The TMA developed in this study will not be commercialized. The results for individuals whose~     tumor specimens are used in the array will not be sent to patients or their treating~     physicians.~   "
245479|NCT00340509|"~     Studies have shown that there is a significant association between serum bilirubin~     concentrations and risk of coronary artery disease (CAD). So far, no linkage analysis in~     humans between serum bilirubin and DNA markers has been reported. The purpose of this~     protocol is to identify chromosome regions that contain quantitative trait loci (QTL)~     involved in serum bilirubin metabolism and bilirubin concentration. In the Framingham Study,~     a 10cM genome scan (about 400 markers) has been conducted in more than three hundred~     families. Serum bilirubin was measured in the first and second exams of the Framingham~     Offspring. These data provide us the opportunity to undertake linkage analyses to map QTL of~     serum bilirubin.~   "
245599|NCT00338858|"~     The purpose of this study is to explore the connection between gait variability parameters~     and balance performance in children with physical disability~   "
245600|NCT00338845|"~     This study will evaluate the effectiveness of the Share Safer Sex Program in reducing sexual~     risk behaviors among female sex workers in four Mexican cities close to the U.S. border.~   "
245480|NCT00340496|"~     Adults treated with X-rays in childhood for benign conditions such as enlarged tonsils and~     adenoids have an increased risk of developing nervous system tumors. The risk is highest for~     schwannomas (RR of 33.1, 95% CI of 9.4-116.5), intermediate for meningiomas (RR of 9.5, 95%~     CI of 3.5-25.7) and lowest for gliomas (RR of 2.6, 95% CI of 0.8-8.6).~      Studies of sporadic tumors of these types have demonstrated the presence of somatic mutations~     in the NF2 gene. Because these mutations are not usually seen in other types of tumors, they~     are believed to be what caused the sporadic neural tumors to develop. Germline mutations in~     the same gene are responsible for the autosomal dominant disorder known as neurofibromatosis~     2 (NF2) which is characterized by the development of similar types of neural tumors.~      The purpose of the proposed study is to determine if neural tumors that developed in people~     who were treated with X-rays in childhood also have somatic NF2 mutations. This will be done~     using DNA from paraffin-embedded neural tumors that developed in ~ 112 individuals treated~     with X-rays in childhood for benign head and neck conditions. These individuals are from a~     cohort of over 4,000 irradiated persons followed by Michael Reese Hospital in Chicago since~     1974. If we find NF2 mutations in the radiation-related tumors, we will determine whether~     they are somatic or germline by looking for NF2 mutations in DNA from buccal cells of the~     patients with the studied tumors. We expect that most patients will have NF2 mutations only~     in tumor DNA. However, there is a remote possibility that one or more patients may have a~     germline NF2 mutation and thus an increased risk of developing neural tumors even in the~     absence of X-ray treatment. We will then compare the types and frequencies of the somatic NF2~     mutations with those found in sporadic neural tumors. If we do not find somatic NF2 mutations~     in the radiation-related tumors, we will conclude that X-rays caused neural tumors to develop~     through interactions with another gene or genes. Either result will contribute to our~     knowledge of radiation tumorigenesis.~      We will send letters describing this study to patients from the Michael Reese Hospital cohort~     who have developed radiation-related neural tumors. Those who consent to take part in it will~     be asked for permission to obtain paraffin blocks from any neural tumor that they have had~     removed and to donate buccal cells for NF2 mutation studies. Finally, they will also be asked~     to complete a questionnaire that will help us update their medical history and obtain a~     medical history on close blood relatives.~   "
245481|NCT00340483|"~     This study, sponsored jointly by the George Washington University School of Public Health and~     the NICHD, will compare the effectiveness of two self-help quit-smoking programs for young~     people.~      Smokers between 18 and 22 years of age who are interested in quitting smoking may be eligible~     for this 6-month study. Candidates must be enrolled in school at least part time.~      Participants are randomly assigned to one of two treatment groups. Both groups receive a~     brief counseling session and self-help guide, and one group also receives email counseling~     related to quitting smoking. All participants have three interviews-one in person at the~     beginning of the program, one over the phone after 2 months in the program, and one in person~     after 6 months, at the end of the program. The surveys cover the participant's intentions and~     behaviors related to smoking cessation and their opinions about the self-help materials. In~     addition, participants may be asked to provide saliva samples at the beginning and end of the~     program for verifying smoking status.~   "
245482|NCT00340470|"~     Teens are at high risk for traffic violations and car crashes because of their young age,~     lack of driving experience, and exposure to high-risk driving conditions. The Checkpoints~     Program has used increased parental restrictions on teen driving through at least the first 4~     months after their children obtain a driver's permit.~      The purpose of this study is to evaluate the efficacy of the Checkpoints Program.~      Approximately 400 teens in Michigan will participate in one of two study groups. One group~     will take standard driver education classes; the other group will take driver education~     classes that incorporate the Checkpoints Program. Teens and their parents will complete a~     written survey after completing the classes and a telephone survey after teens obtain a~     driver's permit. Teens will complete additional telephone surveys 1, 3, 6, and 12 months~     after obtaining a driver's permit. Researchers will use this information to study how parents~     manage teen driving practices, teen driving experiences (amount and conditions of), and~     high-risk teen driving behaviors.~   "
245483|NCT00340457|"~     Incidence rates of renal cell cancer have increased rapidly in the U.S. and other countries.~     In particular, rates among African Americans have risen more sharply than any other cancer~     site. We propose to conduct a population-based case-control study of renal cell cancer in~     areas of the U.S. with a high proportion of African American residents. We will include two~     study centers and one data coordinating center and will recruit study participants over a~     period of four years. We plan to conduct in-person interviews with 2,100 cases (1,400 whites~     and 700 blacks) and 2,800 controls (1,400 each of whites and blacks) to elicit information on~     demographic background and history of exposures. A 40 ml blood sample will be collected from~     living cases and controls to measure certain environmental exposures and for genetic~     analyses. Two buccal cell samples will be collected from living cases and controls for~     genetic analyses. Tumor tissue blocks will be collected from as many cases as possible for~     assays of tumor mutations. Diagnostic slides will be collected for standardized~     reclassification of tumors into clear cell, papillary, and other histologic subtypes. Medical~     records for all cases will be reviewed for health insurance coverage, concomitant conditions,~     presenting symptoms, tumor stage, size and grade, and methods leading to diagnosis of renal~     cell cancer.~   "
245484|NCT00340444|"~     This study will examine the existence of genetic regions that are believed to bring about a~     risk for inflammatory bowel disease (IBD), with its subtypes of Crohn's disease and~     ulcerative colitis. It will identify the locations of chromosomes responsible for hereditary~     IBD through linkage analysis, a technique in genetic research in which the occurrence of a~     disorder in a family is evaluated alongside a known genetic disorder. The project will also~     do fine mapping of genes and examine possible genes associated with IBD.~      IBD is a chronic and often disabling disorder of the gastrointestinal tract, affecting about~     500,000 Americans. Both Crohn's disease and ulcerative colitis share many characteristics,~     such as abdominal pain, bloody diarrhea, fever, fatigue, and malnutrition. But the main~     factors that distinguish these subtypes depend on the location and depth of inflammation.~     Tests and analyses can generally pinpoint some of the differences between the two, but~     sometimes there are major overlaps in characteristics, and the diagnosis is known as~     indeterminate IBD. The exact cause of IBD is not known, but genetic and environmental factors~     are known to contribute to risk for the disease. The single most important environmental risk~     factor has been smoking exposure at the time the diagnosis is made. Also, several genetic~     risk factors are ethnicity, family history, and polymorphisms-abilities to take on different~     forms-in the NOD2 gene.~      Patients who have a diagnosis of IBD and their family members 5 years of age and older who~     have or do not have that diagnosis may be eligible for this study.~      Participants will be asked to complete a questionnaire on their health, ethnic background,~     religion, habits, family medical history, and medications. Information will also be sought on~     the diagnosis, course, complications, and treatment of IBD, as well as risk factors. In~     addition, there will be collection of blood to be used for DNA preparation, storage of~     lymphocytes, and information on immunology.~   "
245587|NCT00339014|"~     The purpose of this study is to determine which of seven combinations of Zonisamide CR and~     Bupropion SR gives the best weight loss and is safe and well tolerated for the treatment of~     obesity not associated with the complications of obesity such as diabetes. In a previous~     study, the combination of zonisamide and bupropion SR was shown to be effective for weight~     loss compared to either zonisamide, bupropion SR alone or placebo. It is thought that by~     adjusting the doses of each drug, giving zonisamide in a controlled release (CR) form and~     increasing the doses more slowly, more weight loss and less side effects can be attained.~   "
245588|NCT00339001|"~     To evaluate the possibility that erythropoietin with early iron supplementation may induce~     retinopathy of prematurity or worsen this disease. In addition risk factors for the~     development of ROP will be checked.~   "
245485|NCT00340431|"~     This study will evaluate the safety of two experimental malaria vaccines in healthy~     volunteers and examine their immune response to them. Safety will be assessed by comparing~     vaccine side effects in groups of volunteers who receive increasing doses of the same vaccine~     (dose-escalating study). Immune response will be evaluated by comparing the levels of~     antibody production with each dose. (Antibodies are infection-fighting proteins produced by~     the immune system.) The two vaccines in this study contain different types of a malaria~     protein called MSP1: one type is MSP142FVO and the other is MSP1423D7.~      Malaria parasites are spread from person to person by mosquitoes. There are four types of~     malaria parasites. The vaccine tested in this study is designed to work against Plasmodium~     falciparum, the parasite responsible for most deaths in children due to malaria in~     sub-Saharan Africa. The vaccine stimulates the body to produce antibodies that prevent P.~     falciparum from entering the person's red blood cells.~      Healthy normal volunteers between 18 and 50 years of age may be eligible for this 12-month~     study, conducted at Quintiles Phase 1 Services in Lenexa, Kansas. Candidates are screened~     with a medical history, physical examination, and blood and urine tests.~      Participants receive three doses of the vaccine-on the first day of the study (day 0), at 1~     month (day 28), and at 6 months (day 180) -through injection into an arm muscle. The first~     group of subjects receives 5 micrograms of vaccine, the second group receives 20 micrograms,~     and the third group receives 80 micrograms. All participants are observed in the clinic for~     30 minutes after each immunization for immediate reactions to the vaccine and keep a record~     of their temperature and of any reactions and side effects they experience for 6 days after~     the vaccination. At various intervals throughout the study, participants undergo a brief~     physical examination and blood tests. Women of childbearing potential have a urine pregnancy~     test on the day of each injection.~   "
245486|NCT00340418|"~     This study will explore the ways in which lung transplants are rejected. A series of~     experiments will evaluate the differences in airway gene expression. Lung transplantation has~     become an important option for patients with advanced lung disease. More than 10,000 patients~     have received them to date, and about 1,200 transplant operations are performed worldwide~     each year. Although short-term survival has continued to improve, the 5-year survival rate is~     less than 50%. Most posttransplant deaths are directly or directly caused by chronic lung~     rejection, a condition of scarring that worsens lung function. .~      Patients ages 18 and older who have received lung transplants, who are undergoing~     bronchoscopy as part of the usual care after transplant, and who are not pregnant may be~     eligible for this study.~      Bronchoscopy and other procedures performed during this study are done only by doctors with~     special training. They will take a total of 30 to 60 minutes. During a bronchoscopy, patients~     will lie on a flat bed. They will be awake and follow instructions. First they will breathe~     Xylocaine (lidocaine), an anesthetic mist, for 8 to 10 minutes. That will lessen the~     discomfort of a small flexible tube called a bronchoscope that will be guided through the~     back of the patient's mouth or nose and into the breathing tubes. When the flexible tube is~     placed, patients will not be able to speak. They will receive the medication Versed~     (midazolam), to make them relaxed and not remember most of the procedure, and fentanyl, to~     decrease the possibility of feeling pain. These medications will be given through a narrow~     tube feeding into a small needle placed into a vein in the arm. The risks of the tube placed~     in the vein include bleeding, swelling, redness, and pain. Side effects from the medications~     may include stomach upset, heart palpitations (awareness of heartbeat), and changes in blood~     pressure. Patients will be carefully monitored for heart rate, blood pressure, breathing, and~     oxygen levels.~      During the bronchoscopy, a procedure called bronchoalveolar lavage is done, in which a small~     amount of germ-free salt water is injected into through the bronchoscope into the lung and~     immediately suctioned back, thus washing the lining of the airways and checking for infection~     and rejection of the transplanted lungs. About 1 or 2 tablespoons of fluid will be collected~     for analysis. Also, an endobronchial brush biopsy may be performed. A small brush removes~     some of the cells from the surface of the airway. These cells will be sent to a laboratory at~     Duke University Health system to analyze the signals from the cells that may eventually led~     to scarring and chronic rejection of the lungs. Then, an endobronchial forceps biopsy is~     performed, in which one or two small pieces, each about the size of a grain of rice, of the~     lining of the lung's large airways is removed. A small surgical tool like tweezers is passed~     into the lung. Risks of biopsies may include bleeding, injury to the lung, or an air leak in~     the lung.~      This study will not have a direct benefit for participants. However, it is hoped that~     information gathered will enhance researchers' understanding of how lung rejection occurs.~   "
245487|NCT00340405|"~     The overall goal of this project is to identify strategies to reduce lung cancer incidence~     and mortality. Using a high-risk occupational cohort, our specific objectives are 1) to~     establish a biologic specimen bank and data bank that can be used for the validation and~     refinement of potential early markers of lung cancer, and 2) to establish a cohort for the~     study of environmental (including dietary) and genetic risk factors for lung cancer.~      Lung cancer is the leading cause of death from malignant neoplasms in the United States and~     in many countries around the world. Potential strategies to reduce the incidence and~     mortality of lung cancer include new methods of early detection and identification and~     alteration of etiologic factors.~      The Yunnan Tin Corporation (YTC), located in Yunnan Province in southern China, is a large,~     nonferrous-metals industry, formed in 1883 and nationalized after the establishment of the~     People's Republic in 1949. It is involved principally in the production of tin from the mines~     around the city of Gejiu. The tin miners at YTC have extremely high rates of lung cancer.~     Among those at high risk, defined as miners 40+ years old with 10+ years of underground~     mining and/or smelting experience, more than one percent per year develop lung cancer. These~     extraordinary lung cancer rates result from combined exposure to radon, arsenic, and tobacco~     smoking in the form of cigarettes and/or bamboo water pipe.~      The study population for the development of a biologic specimen bank for the study of early~     markers of lung cancer is all YTC miners considered to be at high risk for lung cancer based~     on their occupation exposure (40+ years old with 10+ years of underground or smelting~     experience). Currently numbering over 7,000, this high-risk group has been the target for the~     annual lung cancer screening program at the YTC for the past 20+ years. For each high-risk~     miner, sputum samples are collected annually, read for cytologic interpretation, and stored~     in Saccomanno's solution for future early marker research. Screening chest x-rays are also~     obtained. Subjects are followed annually to determine if any have developed lung cancer.~     Diagnostic workup of suspicious cases includes an additional sputum sample and histology~     specimen(s), which are used for diagnostic purposes and also retained for future research.~      Additional biologic specimens have also been obtained on screenees for etiologic research,~     including a one-time collection of whole blood, urine, and toenail clippings. Finger stick~     bloods and buccal smears for DNA will also be sought.~   "
245488|NCT00340392|"~     Background:~        -  Cancer stem cells in breast cancer have been identified as a small population of tumor~          cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be~          necessary for cancer to develop.~        -  These cells can be identified by certain surface markers that overlap with markers~          associated with normal embryonic stem cells.~      Objective: To isolate tumor stem cells using the same methods generally used to isolate human~     embryonic stem cells.~      Eligibility:~        -  Tissue samples will be obtained from the human cooperative network.~        -  Samples will include normal tissues from individuals who have no opportunistic diseases~          and from individuals with cancer.~      Design: Breast cancer stem cells will be isolated, grown in the laboratory and characterized.~   "
245489|NCT00340379|"~     The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of~     psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.~   "
245490|NCT00340366|"~     This study will examine how the body metabolizes micronutrients, such vitamins, during~     pregnancy and how genetic make-up influences their metabolism. Vitamin B12 and folate levels~     in pregnancy have been linked to birth defects, such as neural tube defects, orofacial~     clefts, and congenital heart disease. Other micronutrient levels may be related to other~     birth defects or pregnancy complications. This study will characterize the patterns of~     micronutrient status during pregnancy and compare it with genetic variants and biochemical~     parameters. Information about the relationship between genes and vitamin metabolism may help~     doctors advise women about their nutritional requirements during pregnancy to protect their~     health and the health of their babies.~      This study is a collaboration between NIH and Trinity College in Dublin, Ireland. Women of~     Irish origin 18 years of age or older who are receiving prenatal care at the Coombe Women's~     Hospital in Dublin may be enrolled. Fathers also may participate.~      Upon entering the study, female participants complete a questionnaire relating to their food~     and vitamin intake, alcohol consumption, smoking behavior, and use of medications, and~     provide a blood sample. Additional blood samples are collected during routine clinic visits~     at about 24 and 34 weeks of pregnancy, and again at delivery and from 6 weeks to 2 months~     after the baby's birth. Permission will be requested to obtain a blood sample from the~     umbilical cord at birth after it has been removed from the baby.~      Fathers of the babies are also asked to answer a short questionnaire and to provide a DNA~     sample for genetic studies. To collect the DNA, sterile cotton swabs are rubbed around the~     inside of the mouth to obtain cheek cells from which the DNA is extracted.~   "
245491|NCT00340353|"~     Background:~      Alveolar soft part sarcoma (ASPS) is a rare tumor.~      ASPS is resistant to chemotherapy and radiation.~      ASPS is characterized by slow growth.~      Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic~     studies or biological investigations.~      Primary Objectives:~      Acquisition of blood and tissue from patients with ASPS.~      Acquisition of blood from healthy controls for comparison with blood from patients with ASPS.~     These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046.~      Eligibility:~      Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who~     are undergoing medically indicated surgery for their disease.~      Design:~      Patients with Alveolar Soft Part Sarcoma (ASPS) will be eligible for this study. Biopsy~     tissue will be obtained as an additional sample at the time of a medically indicated~     procedure. Blood sample may be collected at initial visit and follow-up visits. Specific~     risks will be described in a separate consent to be obtained at the time of the biopsy. Tumor~     samples and blood samples will be processed and/or stored for use in research efforts in the~     laboratory of Dr. David Vistica, National Cancer Institute, Frederick, MD. Additionally,~     blood samples will be obtained from healthy volunteers for comparison to patients with ASPS.~     These control samples will be obtained from the National Cancer Institute at Frederick~     Protocol OH99-C-N046.~   "
245492|NCT00340340|"~     We will conduct an interdisciplinary case-control/sib-pair study of lung cancer designed to~     explore the genetic determinants both of lung cancer and of smoking. The study includes~     biospecimen collection as well as exposure information with power to address main genetic~     effects and gene-environment interactions.~      This is an integrated proposal designed to address two major issues: the genetic determinants~     of lung cancer in smokers and the genetic determinants of smoking. Other important issues~     will be addressed in the study with a marginal additional cost to the main design. The study~     achieves excellent power for studying the main effects of genetic factors that are relatively~     common and good power for formal tests of interactive effects.~      Using a case-control design, with questionnaire, medical record abstraction, and blood~     collection, we will investigate: main effects of genes on lung cancer risk; gene-environment~     and gene-gene effects in lung cancer etiology; gene effects on smoking persistence; gene~     effects on ever-never smoking; gene-psychological interactions in smoking behaviors.~      In addition, we will collect viable lymphocytes from all study subjects and tumor,~     metaplastic and normal tissue samples from 100 surgical cases. With these data and tissues,~     we will be able to study: genetic instabilities in lung cancer tissue in relation to specific~     exposures, genotype, persistence of smoking, and clinical presentation of lung cancer;~     histologic characteristics of lung cancer in relation to genotype, gene expression, somatic~     mutations, and smoking; functional assays in viable lmphocytes in relation to genotype, gene~     expression.~      Finally, we will identify lung cancer-affected siblings of cases, and the unaffected siblings~     in the same sibships. This sample will permit us to: replicate associations found in the~     case-control sample with an alternative analytical method based on transmission statistics;~     address some population stratification issues.~   "
245493|NCT00340327|"~     The purpose of this study is to evaluate the safety and drug levels for single, ascending~     doses of IMA-638 in healthy Japanese subjects.~   "
245494|NCT00340314|"~     Background: Circumferential pulmonary vein ablation (CPVA) has been safely and effectively~     performed for treating paroxysmal atrial fibrillation (PAF); however, its safety and~     efficacy, as compared with those of antiarrhythmic drug therapy (ADT), have never been~     formally assessed in a randomized controlled trial.~      The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a~     randomized controlled trial.~   "
245495|NCT00340301|"~     Chemicals called neurotoxins can harm the nervous system. Amyotrophic lateral sclerosis (ALS)~     is a progressive disease affecting movement. Researchers have studied many possible causes of~     ALS, including injury, diet, and exposure to chemicals, but these studies were inconclusive.~      The purpose of this study was to determine whether exposure to lead or other neurotoxins can~     contribute to ALS. The study also evaluated lifestyle and dietary patterns. The study was~     completed in 1994-1996.~      One hundred eighty-two participants took part in this study 110 patients with ALS and 72 who~     did not have ALS. Each completed a questionnaire concerning lifestyle, diet, and residential,~     job, and medical history. Participants contributed 50 cc of blood, used to measure lead, as~     well as clippings of their toenails, used to measure mercury and other metals. They then~     underwent an XRF test (an X-ray procedure) to measure the level of lead in their shinbones~     and knees. Genes related to ALS or susceptibility to lead exposure were also evaluated.~   "
245496|NCT00340288|"~     Uterine leiomyomas, commonly called fibroids, are a major health concern for women of~     reproductive age. The objectives of the study described herein are to investigate the growth~     dynamics of uterine leiomyomas in a clinically relevant population of women. We will test the~     hypotheses that uterine leiomyomas are heterogeneous in terms of their growth characteristics~     and in their clinical symptoms or outcomes, and that differences in leiomyoma growth dynamics~     can be discriminated by molecular markers and cellular phenotypes. Participants will include~     300 premenopausal women (greater than 18 years old) with at least one uterine leiomyoma. The~     inclusion criteria for patient enrollment is confirmed diagnosis of leiomyoma by ultrasound.~     At least one leiomyoma must be equal to or greater than 2 cm in diameter and the uterus must~     be enlarged to the size typical during the eigth week of pregnancy. After enrollment and~     informed consent, T1- and T2-weighted magnetic resonance image (MRI) scans will be conducted~     beginning at the first visit and then at 3, 6, and 12 months. Each patient will have a~     physical exam, provide urine and blood samples at each MRI visit, and respond to an initial~     extensive telephone-administered questionnaire followed by abbreviated monthly questionnaire~     updates. A number of the enrolled women will require surgical intervention~     (hysterectomy/myomectomy) as standard care. If surgery is an outcome for women enrolled in~     the study, MRI will be conducted before surgery and the surgical pathologist will map uterine~     leiomyomas for comparison to MRI. Leiomyoma samples will be analyzed for histopathological~     and molecular changes correlated with growth. Because hysterectomy and myomectomy are common~     outcomes in women with leiomyomas, we anticipate tissue will be available from at least 100~     of the 300 women in the study. For those women who opt for surgery, we will also administer a~     brief (less than 5 minute) questionnaire clarifying their reason for electing surgery. Upon~     completion of data collection, we will be able to compare leiomyoma growth as a function of~     multiplicity and location; examine the relationship between leiomyoma growth and clinical~     symptoms or outcome; identify molecular, cellular, and pathological characteristics of~     leiomyomas with differing growth dynamics; and examine endocrinological parameters and~     lifestyle factors related to differential growth dynamics of uterine leiomyomas. The data may~     be used to establish a clinical severity scale and establish diagnostic markers currently not~     available for uterine leiomyomas.~   "
245497|NCT00340275|"~     Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial~     flora. It is present in 10 to 25% of women in the general population, and is the most common~     vaginal infection. It has been associated with a number of adverse sequelae in reproductive~     health including acquisition of HIV, pelvic inflammatory disease, cervical dysplasia, and~     complications of gynecological procedures. During pregnancy it has been associated with an~     increased risk of preterm birth an postpartum maternal infection. However, the vaginal~     microbial flora remains poorly understood. Information on variation in microbial flora and~     its association with BV from a longitudinal study is unavailable. This prospective~     observational study aims to advance our knowledge of the natural history and abnormal~     alteration in vaginal microbial flora, and to identify risk factors that are associated with~     these changes. A total of 5500 healthy, non-pregnant women of reproductive age will be~     enrolled and followed up in Birmingham, Alabama, for one year (baseline visit plus once every~     three months afterwards, totaling 5 visits). Detailed information on sociodemographic status,~     medical history, hygiene practice, sexual behavior and psychosocial stress will be collected~     through in-person interviews. Routine gynecological and dental examinations will be carried~     out during the study visits. Samples of vaginal secretion and blood will be collected.~     Laboratory tests to quantify vaginal microbial flora and to identify infection of bacterial~     vaginosis as well as common sexually transmitted diseases will be conducted. This project is~     expected to complete in 5 years.~   "
245504|NCT00340158|"~     Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer~     that disproportionately impacts young women. IBC often affects the skin of the breast, as~     well as the breast itself, making it appear inflamed. The purpose of this study is to collect~     data and information on IBC patients so that researchers can study factors associated with~     IBC. The data and information collected will be used to establish the IBC Registry, a private~     cancer registry.~      Approximately 300 persons who are 18 years or older and who have been diagnosed with IBC will~     participate in this study. Participants will provide researchers with access to their medical~     and pathology records, slides, tissue, and x-rays. They also will consent to a 15-minute~     telephone interview concerning general information about themselves and the initial~     manifestation of IBC and to a 30-minute interview about their medical history.~   "
245601|NCT00338832|"~     This study will evaluate the effectiveness of a lifestyle intervention in increasing physical~     activity and reducing disease symptoms in sedentary adults with schizophrenia.~   "
245498|NCT00340262|"~     Recent cohort studies demonstrated reduced breast cancer risks among women with a history of~     fractures or low bone mineral density (BMD). In the Study of Osteoporotic Fractures, each~     standard deviation increase in distal radius BMD was associated with a 50% increased risk~     over three years of follow-up, while in the Framingham study, women in the highest quartile~     of metacarpal bone mass had a 3.5-fold higher risk than women in the lowest quartile. The~     impact of the severity and timing of bone loss on risk has not yet been investigated, and the~     extent to which other risk factors (family history, anthropometric factors, physical~     activity, and exogenous hormones) modify the relationship with BMD is unknown.~      To elaborate on these research questions, we are conducting a follow-up study of 22,695~     postmenopausal women who volunteered for the Fracture Intervention Trial (FIT), a trial of~     the bone-enhancing drug alendronate. This large cohort includes extensive baseline~     information on major breast cancer risk factors, and thus is ideal for evaluating potential~     interactions with BMD and the effects of BMD on other cancer sites. Endometrial cancer has~     been reported to occur more frequently among women with a history of fracture, but no~     previous studies have specifically investigated its relationship to BMD.~      We are investigating whether BMD of the proximal femur predicts breast cancer risk; whether~     breast cancer risk factors among postmenopausal women modify the relationship with BMD;~     whether BMD predicts endometrial or other cancers; and whether measurable biomarkers offer~     further etiologic clues about BMD and cancer risk.~      We have contacted the surviving members of FIT to ascertain incident cancers. Risk factors~     and fracture history are being updated through a self-administered questionnaire. To~     supplement the serum samples collected at baseline, we are using a nested case-control study~     approach to collect buccal cell specimens, which may be useful for measuring a variety of~     biomarkers, including endogenous hormones and genetic polymorphisms involved in either bone~     growth (e.g., vitamin D receptor) or hormone metabolism (e.g., CYP17, COMT). Retrieval of~     operative and pathology reports is being used to validate self-reported cancers. The social~     security numbers and contacts names provided by FIT participants when they completed the~     baseline questionnaire are facilitating comprehensive follow-up and a National Death Index~     search for those who cannot be located. The baseline data, the established cooperation of~     this study population, and the collection of additional biospecimens should enable this study~     to answer important questions about BMD in breast and endometrial cancers.~   "
245499|NCT00340249|"~     The purpose of this application is to request permission to use a bank of biological~     specimens and clinical information collected by the investigators prior to their joining the~     intramural program. The samples have been gathered under the sponsorship and approval of the~     Human Investigations Committees at Yale University, Wayne State University and Pennsylvania~     Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the~     Universidad de Chile and the Universidad Catolica de Chile, in Chile. The investigators~     have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained~     at the time of delivery (from the umbilical cord and by cordocentesis), neonate's urine and~     sonographic examinations of the fetus, including echocardiography, stored on video-tapes.~     Clinical information with patient identifiers is available for these samples and sonographic~     examinations.~   "
245500|NCT00340223|"~     This study will identify variations in the genome of the human immunodeficiency virus (HIV)~     early after infection and following the development of AIDS. It will analyze genetic material~     and clinical data from HIV-positive individuals to assess differences in viral epitopes~     between patients with two different gene alleles (alternative forms of a gene)-B*3501 and~     B*3503. (An epitope is a molecular region on the surface of an antigen capable of eliciting~     an immune response and of combining with the specific antibody produced by such a response.)~      HIV disease in people with the B*3503 allele progresses significantly faster than it does in~     people with the B*3501 allele. This study might provide information that is potentially~     useful in developing a successful HIV vaccine.~      Blood samples and clinical data for analysis will be obtained from the Johns Hopkins~     Bloomberg School of Public Health; the University of Pittsburgh; the John H. Stroger, Jr.~     Hospital of Cook County; the Howard Brown Health Center; Northwestern University; and the~     University of California at Los Angeles.~   "
245501|NCT00340210|"~     The Columbia, MO Serum Bank initially was established in 1977 as part of the National Cancer~     Institute's (NCI) Biological Markers Project to identify serum markers for breast cancer.~     Participants were volunteers identified through the Breast Cancer Detection Demonstration~     Project (BCDDP) at the University of Missouri Hospital and Ellis Fischel Cancer Center in~     Columbia, MO. A total of 6,915 women without a prior history of cancer, other than~     non-melanoma skin cancer, donated blood to the bank on one or more occasions between 1977 and~     1987.~      At the time of each blood collection, interview information was obtained including age,~     height, weight, reproductive and menstrual histories, family history of breast cancer,~     medical conditions, and drug use, including oral contraceptives and menopausal hormone~     therapy. Date of last menstrual period was captured for women who were premenopausal at the~     time of each blood collection. Approximately 30% of the women donated multiple samples over~     the first 10 years of the study, (including 20% with 3 or more samples), with collections~     occurring on average one year apart. At each collection, serum was aliquoted into up to ten,~     1 ml vials and stored at -70 (Infinite)C at the NCI Repository. All women gave informed~     consent before donating to the serum bank.~      The initial follow-up continued for up to 12 years through 1989, with 244 cancers identified.~     Of the 6915 original participants, 79% were last seen in 1983 or earlier, yielding a median~     follow-up time of 4 years. A questionnaire was mailed to all participants annually to~     ascertain information on interim breast biopsies and cancer diagnoses. Women who indicated~     that they had a breast biopsy or breast cancer were sent a consent form for permission to~     obtain medical records including pathology reports. For cancers at sites other than the~     breast, medical records and pathology reports were not requested, although date of diagnosis~     and site were ascertained.~      Between 1999 and 2002, an extended follow-up of Columbia, MO Serum Bank participants was~     conducted. Of the 6915 original participants, 6,720 women had blood remaining and were~     included in this phase of the study. Of these, 6,154 (91.6%) were located; 566 (8%) were not~     locatable, 109 (2%) refused to participate, and 40 (<1%) were too ill to participate. 1,694~     women (25%) were deceased. This last follow-up identified an additional 1123 cancers. This~     cohort has serum samples from a cohort of 6720 pre- and postmenopausal women followed up to~     20 years for cancer diagnoses and is a unique resource for molecular epidemiologic studies~     exploring serum markers associated with cancer risk.~   "
245502|NCT00340184|"~     The purpose of this study is to determine whether post-operative concurrent chemoradiation~     with paclitaxel/carboplatin is effective and safe in the treatment of high risk cervical~     cancer patients.~   "
245503|NCT00340171|"~     Fetal growth abnormalities, such as macrosomia and intrauterine growth retardation, are an~     important cause for increased perinatal mortality in the United States. Toward this end,~     accurate fetal weight determinations are very important for guiding prenatal care.~     Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the~     fetus. This technique allows one to arbitrarily scan through a digital ultrasound volume~     dataset, visualize organs from different perspectives, and render anatomical features through~     computer processing. It also allows the retrospective measurement of distances and volumes~     even in the physical absence of the patient.~      A maximum of 400 pregnancies will be serially studied by three-dimensional ultrasound to~     characterize the growth of volume parameters such as the fetal thigh. This information will~     be applied to the Rossavik model of individualized growth assessment. The technique allows~     growth evaluation by comparing various ultrasound measurements or birth characteristics to~     the individual growth standards specified by the prediction model. Newborn infant body~     composition will also be studied within 48 hours of delivery.~      A separate cross-sectional study of up to 2,577 fetuses will allow development of birth~     weight prediction models based upon fetal volume measurements and further analysis of fetal~     growth abnormalities. Individual growth curve standards utilizing these volume parameters~     should allow one to evaluate deviations from expected growth or birth weight by using each~     fetus as its own control.~   "
245505|NCT00340132|"~     The Pima Indians of Arizona have the highest prevalence and incidence of type 2 diabetes of~     any population in the world. Prospective analyses in this population have identified insulin~     resistance and a defect in early insulin secretion as risk factors for the development of the~     disease. A recent longitudinal analysis which tracked the development of diabetes in 17 Pima~     Indians demonstrated that both insulin action and early insulin secretion deteriorate as~     individuals progress from normal to impaired glucose tolerance and then to diabetes. These~     results suggest that both inherent (apparent in normal glucose tolerant subjects who progress~     to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress~     from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action~     and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and~     environmental determinants of diabetes we plan to study Pima Indian families to determine:~     (1) if there are genes that segregate with metabolic risk factors for diabetes which might~     therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and~     environmental determinants of insulin resistance and impaired insulin secretion.~      Volunteers for this study will be admitted to the clinical research ward where they will~     undergo several tests to determine body composition, oral and intravenous glucose tolerance~     and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle~     tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and~     insulin action in these tissues. A transformed lymphocyte cell line will be established for~     each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2~     diabetes and insulin resistance will be sought by typing each individual at positional and~     functional candidate loci in the hopes of finding an association between these loci and~     obesity, insulin secretion, insulin resistance and/or type 2 diabetes.~   "
245506|NCT00340119|"~     This study, done in collaboration with Johns Hopkins University School of Public Health in~     Baltimore, Maryland, will examine the role of genes in the development of atherosclerotic~     cardiovascular disease (CVD) in patients undergoing kidney dialysis. The rate of illness and~     death from CVD among patients on dialysis is extraordinarily high, accounting for about 50~     percent of deaths. Blood levels of inflammatory markers are elevated in these patients,~     strongly predicting illness and death from CVD. The discovery of gene variants related to the~     inflammatory process in atherosclerotic CVD may lead to better medical treatments and~     improved survival in patients with end-stage kidney disease.~      Participants of John's Hopkins University's CHOICE (Choices for Healthy Outcomes in Caring~     for End-Stage Renal Disease) program are included in this study. Blood samples previously~     collected from these patients will be analyzed in the laboratory for genes that might be~     associated with the inflammatory process and atherogenesis.~   "
245507|NCT00340106|"~     This study will: 1) test the effectiveness of a program to prevent the exposure of infants to~     environmental tobacco smoke; and 2) evaluate the health effects associated with prenatal and~     postpartum exposure to tobacco smoke products and environmental tobacco smoke among infants.~      African-American and Hispanic women who are 18 years of age or older, and who are between 28~     and 35 weeks pregnant may be eligible for this study. Participants complete an interview and~     home visit assessment and are then randomly assigned to participate in Program A or Program B~     of the study, as follows:~      Program A: Involves discussions with an Infant Health Advisor about parenting skills to~     promote child safety and infant growth and development, such as ways to prevent childhood~     injuries caused by falls, poisons, and other hazards.~      Program B: Involves discussions with an Infant Health Advisor about ways to prevent infant~     tobacco smoke exposure, such as how to adopt smoke-free household rules in the home and how~     to work with friends and family members to prevent the baby from being exposed to tobacco~     smoke. In addition, participants who smoked cigarettes before becoming pregnant or while~     pregnant are given advice on how to quit smoking and how to remain a non-smoker once the baby~     is born.~      Participants come to the clinic four times- once during a regularly scheduled prenatal visit~     and again when the baby is 6 weeks, 4 months, and 6 months old - to see the Infant Health~     Advisor for the activities described above in Program A or Program B. Between visits, the~     Advisor calls the participant to check on her progress regarding the program objectives. In~     addition, the study involves the following for all participants:~        -  Telephone interview during the week after joining the study to obtain information on~          participant's background, pregnancy and family history, tobacco use and exposure to~          other people's cigarette smoke during pregnancy, strategies to reduce tobacco use and~          exposure, stressful life events, drug and alcohol use during pregnancy, and sources of~          social support. Similar interviews are repeated when the baby is 6 weeks old, and again~          when the baby is 4 months, 6 months, and 12 months old.~        -  Home visit about 1 week after entering the study to check the home for possible safety~          hazards to the baby and to place one or more nicotine air monitors (small plastic~          objects that measure the amount of tobacco smoke in the air of each room). The home~          visitor returns a week late...~   "
245508|NCT00340093|"~     This 1-year study will test the feasibility and effectiveness of a diabetes personal trainer~     in helping youth with diabetes manage their treatment. It will examine how families with a~     diabetic child handle the responsibilities of managing diabetes and deal with the changes~     that come with managing the illness as the child grows up.~      Children between 11 and 16 years of age receiving treatment for diabetes type 1 at Johns~     Hopkins University Medical Center may be eligible for this study. The children must have been~     diagnosed with diabetes at least 1 year before entering the study and must require insulin~     treatment. One parent of each child will also participate.~      On entering the study, each child and parent will be interviewed about various topics having~     to do with taking care of diabetes. After the interview, the children will be randomly~     assigned to one of two groups: Group 1 will receive education information about diabetes~     management; Group 2 will be enrolled in a program in which they meet with a diabetes personal~     trainer 6 to 7 times over 2 months for individualized instruction in planning and evaluating~     their diabetes care activities. They will also keep in contact with their trainer by~     telephone.~      Children in Group 2 will be given a hand-held personal computer device in which they will~     keep a record of all diabetes-related activities for 3 days, including insulin shots, meals~     and snacks. In addition, they will wear an accelerometer, a small device that keeps track of~     the amount of movement they make. At the end of each of the 3 days, the child will complete a~     20- to 30-minute telephone interview reviewing the day. They will have a tape-recorded~     interview about their experiences in taking care of diabetes. Their meetings with the~     personal trainer also may be taped.~      Children in both groups will continue to see the doctor at the clinic as they normally would.~      At 2 and 6 months after starting the study, children in both groups will complete a telephone~     interview about diabetes management. At 12 months they will complete an in-person interview.~   "
245509|NCT00340080|"~     Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of~     abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from~     Europe, Australia and other countries as applicable. The study has two (co-primary)~     objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results~     in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic~     screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART,~     results in a significantly lower incidence of immunologically-confirmed HSR versus current~     standard of care (no genetic screening or patch testing). The study consists of up to a~     28-day screening period, a randomised observation period (Day 1 through Week 6) and, for~     subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an~     epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one~     of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control)~     and a Genetic Screening Arm (prospective genetic screening). Subjects identified as~     HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be~     excluded from further study. Subjects who experience suspected ABC HSR during the 6-week~     observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6~     weeks later.~   "
245510|NCT00340054|"~     RATIONALE: Electric and magnetic fields may increase the risk of cancer. Developing interview~     questions that accurately estimate a person's exposure to electric and magnetic fields may~     help doctors learn about the long-term effects of workplace exposure.~      PURPOSE: This clinical trial is developing interview questions that can be used in estimating~     workplace exposure to electric and magnetic fields.~   "
245602|NCT00338819|"~     Purpose:~      To test the hemodynamic profile generated by the MCS’s ActiveCare+SFT device in ventilated~     patients and compare it to that of the Kendall SCD Express.~      Design:~      Comparative, prospective study. Patients are their own controls.~   "
245511|NCT00340028|"~     This study will analyze hormones in early pregnancy. Hormonal changes in early pregnancy~     reflect the quality of implantation in the uterus of the fertilized egg, the function of the~     corpus luteum (mass of hormone-secreting tissue that forms immediately after ovulation) and~     placenta, and the health of the embryo. It will determine the following:~        -  Whether early pregnancy hormones vary by characteristics of the mother~        -  Whether early pregnancy hormones differ for pregnancies with male or female babies~        -  Whether early pregnancy hormones can predict the gestational age (age of the baby during~          pregnancy) and the baby's birth weight~        -  Hormone activity at the time pregnancy symptoms begin~        -  How the contribution of the corpus luteum changes during the pregnancy in different~          women~      Stored urine specimens collected from women who participated in the North Carolina Early~     Pregnancy Study in the 1980s will be used for this study. In addition, to evaluate the~     quality of the stored samples, new specimens will be collected from women currently enrolled~     in the University of North Carolina's Right from the Start study. Candidates must be white~     women not of Latino or Hispanic origin who are between 25 and 35 years of age and who are~     planning to become pregnant within a few months' time. They must be non-smokers, have regular~     menstrual cycles, no known fertility problems and no major chronic disease.~      Urine specimens are analyzed for hormone levels and other changes in early pregnancy that can~     be measured in urine. Women providing new urine specimens do the following:~      Pre-Pregnancy~      The pre-pregnancy part of the study lasts through no more than three consecutive menstrual~     cycles. Participants who do not become pregnant after three menstrual cycles end the study at~     that time.~        -  Have a short interview with a study staff member~        -  Complete a daily diary, recording any vaginal bleeding or spotting, health status, and~          use of medications, and mail the diary to the study office once a week~        -  Use an ovulation testing kit for up to 7 days during their menstrual cycle~        -  Call the study staff within the first 24 hours of becoming pregnant~      Pregnancy~      The pregnancy part of the study lasts about 5 weeks.~        -  Continue to complete daily diary records for weekly pickup by staff member~        -  Collect urine samples daily and store them in the freezer for weekly pickup by staff~          member~        -  Have 1 to 2 tablespoons of blood drawn at home weekly for 4 weeks~        -  Have a brief follow-up telephone interview around week 12 of their pregnancy~      Urine samples are analyzed for hormones such as human chorionic gonadotropin,~     estrone-3-glucuronide, and pregnanedrol glucuronide. White blood cells are stored for DNA to~     study such things as genes controlling hormone metabolism.~   "
245512|NCT00340015|"~     This is a prospective cohort study of diet and cancer in relation to several major cancers,~     especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old~     male and female members of the American Association of Retired Persons (AARP). In 1995-6 we~     mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members~     responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates~     that the cohort, both men and women, has the desired wide distributions of percent calories~     from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the~     initial respondents (with satisfactory data) returned a second questionnaire containing~     questions on exposures not assessed in the first instrument.~      In terms of field activities, the study has been relatively quiescent over the past year. At~     the end of the five-year period of observation, we will mail to cohort members a brief~     follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer~     registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up~     will be largely passive, through established state registries. The initial questionnaire~     mailing will be to AARP members in those states selected on the basis of having registries~     with adequate coverage and quality. We will use active follow-up, with record retrieval, for~     the small percentage of cohort members who have moved out of the cancer registry areas. The~     buccal cell collection pilot study has been completed; over 50% of those pilot study~     partricipants who had completed the baseline and risk factor questionnaires returned buccal~     cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure~     indicate that cohort incidence rates for major cancers, determined from registry data, are~     consistent with SEER rates.~   "
245513|NCT00340002|"~     A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This~     capability allows clinicians to make prudent decisions regarding antepartum care, delivery~     site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that~     provides a new way to evaluate the fetus. This technique allows one to scan through a digital~     ultrasound volume dataset, visualize organs from different perspectives, measure volumes, and~     render anatomical features through computer processing. However, the accurate~     characterization of fetal anomalies by this technique must be interpreted in relation to~     normal fetal anatomy at different stages of pregnancy.~      We are continuing to develop an image reference library of fetal anatomy by identifying key~     diagnostic features by three-dimensional ultrasound. A cross-sectional observational study of~     up to 1,400 fetuses will catalog a broad spectrum of congenital malformations at various~     gestational ages. The protocol will include up to 400 examples of normal fetal anatomy by~     three-dimensional ultrasonography.~      All cases will be placed into a digital image database. For each anomaly category, volume~     reconstructions will be compared to normal anatomy at specific gestational ages. Key~     diagnostic findings will be documented and correlated with postnatal outcome. We anticipate~     that our results will permit improved diagnostic interpretation of congenital defects~     throughout pregnancy.~   "
245514|NCT00339989|"~     This study, conducted by the National Cancer Institute and the University of Oklahoma, will~     look for changes in cervix cells and other samples that may be signs of cervical disease.~     Human papilloma virus, or HPV, is a common infection of the genitalia in women that usually~     goes away by itself. If HPV infection does not go away, it might turn into cancer of the~     cervix, although this is rare. This study will examine why many HPV infections go away and~     why a few persist and lead to cervical cancer.~      Women 18 years of age and older who are referred for colposcopy (examination of the vagina~     and cervix using an instrument with a magnifying lens) at the University of Oklahoma~     following Pap smear diagnosis may be eligible for this study. Women will be in one of the~     following diagnostic categories:~        -  Cancer: Stage 1-2 only.~        -  Precancer: Cervical intraepithelial neoplasia (CIN3).~        -  HPV-infected: Positive for any of the 13 known cancer-causing HPV types, but not~          diagnosed with cancer or CIN3.~        -  Normal: Negative for cancer-causing HPV and normal tissue laboratory results.~      Participants will undergo the following procedures:~        -  Questionnaire: Covers demographic information (such as age, race, ethnicity, marital~          status, etc.), pregnancy history, menstrual and sexual history, contraceptive history,~          hormone medication history, medical history, smoking history, physical development,~          family history, and health care access.~        -  Blood test: 2 tablespoons of blood drawn.~        -  Colposcopy.~        -  Procedure to collect a sample of cervical cells and fluids for HPV testing and research.~   "
245515|NCT00339976|"~     This study is a follow-up to an earlier study that examined the relationship of This study~     will examine whether exposure to neurotoxins, such as lead, mercury, solvents, and~     pesticides, can contribute to amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's~     disease. The cause of this degenerative disease of the brain and spinal cord is not well~     understood. Some studies suggest that exposure to environmental neurotoxins may increase its~     risk. This follow-up study will examine the relationship of neurotoxin exposure to the~     interval between the diagnosis of ALS and death. It will also examine the possible roles of~     genetics, lifestyle and dietary factors in the disease. Information on ALS patients~     previously enrolled in the study will be used to examine this relationship. No new~     individuals will be enrolled in the study.~   "
245603|NCT00338806|"~     This study will develop strategies for early detection and prevention of mood disorders and~     associated impairment in adolescent children of parents with bipolar disorder.~   "
246750|NCT00323310|"~     The purpose of this study was to assess the safety and enhancing properties of the magnetic~     resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having~     central nervous system (CNS) disorders.~   "
245516|NCT00339963|"~     This study will use genomics-based technology, such as DNA microarrays, to more precisely~     diagnose subsets of lymphoma, leukemia and multiple myeloma patients. There have been many~     attempts to classify lymphoid cancers in ways that will be useful for clinical diagnosis and~     treatment. Although broad diagnostic categories have been reliably defined, patients within~     each category have distinct clinical courses, suggesting that these classifications could be~     further divided into molecular (genetic) subtypes. For example, 40 percent of patients with~     diffuse large B-cell lymphoma achieve long-term disease remissions following combination~     chemotherapy and are apparently cured, whereas the remaining 60 percent die from the disease.~     Similarly, some patients with follicular lymphoma develop aggressive disease within a few~     years of diagnosis, while others have stable disease over 10 to 20 years. Although the~     distinctions in clinical course of these diseases are recognized, there are no studies to~     determine the molecular (genetic) basis for this variability. This study will try to define~     new molecular diagnostic categories in these diseases and correlate them with clinical~     features, including treatment response, disease remission and overall survival following~     chemotherapy.~      This retrospective study will use clinical data and tissue samples from participating centers~     in the Lymphoma/Leukemia Molecular Profiling Project LLMPP). New patients will not be~     recruited for this study.~      Biopsy materials, including fresh frozen or OTC-embedded lymphoma biopsy material, viably~     frozen samples of peripheral blood cells from leukemia patients, and viably frozen samples of~     bone marrow aspirates from multiple myeloma patients will be collected from pathologists~     participating in the LLMPP. RNA and genomic DNA will be extracted from the tumor samples. A~     variety of technologies will be used to characterize the genome of the cancer cells,~     including lymphochip microarrays for array-based comparative genomic hybridization; Southern~     blotting and PCR for translocation of genes previously implicated in these malignancies; and~     PCR and DNA sequencing methods for analyzing base changes in the genome of the cancer cells.~     Clinical information from the initial diagnosis to disease relapse will be taken from~     existing databases and/or patient charts. Gene expression will be correlated with the~     clinical data. If a small number of genes is found to strongly predict clinical outcome,~     quantitative RT-PCR assays using the Taqman technology may be developed as an alternative to~     DNA microarray analysis.~   "
245517|NCT00339950|"~     The CONCeRN Trial is a multi-center study of asymptomatic women between the ages of 40 and 75~     referred to regional military medical centers for routine colorectal screening. The primary~     purpose of the main study is to determine the extent to which advanced neoplastic lesions~     will be missed if clinicians only perform sigmoidoscopies rather than full colonoscopies as a~     screening procedure and to resolve current debate about the significance of sigmoidoscopic~     detection of single, small, tubular adenomas (i.e., do they imply greater risk for large~     adenomatous polyps or colorectal cancer at other sites beyond the reach of the sigmoidoscope,~     or is there no increased risk?). Women enrolled in the trial receive colonoscopy during which~     all identified polyps are removed and also during which two pinch biopsies of~     apparently-normal tissue are taken. In addition, before the colonoscopy is performed,~     patients wil have blood drawn and answer a brief questionnaire on risk factors for colorectal~     cancer. The sub-study proposes to add on a more extensive questionnaire to assess dietary and~     other lifesyle factors potentially related to colorectal cancer, and to draw additional blood~     for assessment of nutritional status and for analysis of genetic polymorphisms related to~     colorectal cancer. With the additional information available from these questionnaires and~     blood samples, it will be possible to explore the extent to which various dietary and genetic~     risk factors are related to colorectal polyps in asymptomatic women of average risk for~     disease.~   "
245518|NCT00339937|"~     A series of studies will be conducted in Sicily by a collaborative team from the U.S.~     National Cancer Institute and the University of Palermo to better understand the prevalence~     and risk factors for the newly discovered human herpes virus 8 (HHV8) and Kaposi s sarcoma~     (KS), which may be a consequence of HHV8 infection. There are four short-term projects:~        1. To determine HHV8 seroprevalence in extant, unlinked sera from informative groups,~          including homosexual men, persons with sexually transmitted diseases, and in general~          population groups, particularly the elderly. In addition, HHV8 prevalence and other~          serological studies may be determined among other adults, particularly those who may be~          recruited for future studies and those likely to enhance understanding of HHV8 serology.~        2. To identify a pediatric syndrome that might be associated with HHV8 infection, HHV8~          seroprevalence will be determined in sera from hospitalized children with a wide range~          of clinical conditions.~        3. To determine HHV8 seroprevalence in various regions of Italy and by HLA Class II groups~          that have been linked to increased (HLA-DR5) or decreased (HLA-DR3) risk of KS, using~          extant, unlinked sera and data from volunteer bone marrow donors.~        4. To conduct a case control study that will identify risk factors for KS among persons who~          are infected with HHV8 and who manifest anti-HHV8 latent antibodies.~      The results of these projects will be summarized for publication in the medical and~     scientific literature and for the design and prioritization of related projects in the~     future.~   "
245519|NCT00339924|"~     This study will develop a survey instrument to measure primary care physicians' knowledge of~     the variation in human genetics, their beliefs about biologic and genetic differences~     according to patients' race and ethnicity, and how that knowledge is used in their clinical~     decision making.~      Genomics research today is such that primary care physicians will be responsible for~     translating new genetic knowledge, drug therapies, and single and multiplex genetic testing~     into clinical practice.~      Physicians who are board certified general internists, including those who practice and teach~     in research and teaching hospitals in urban areas of the United States, may be eligible for~     this study. Participants will be recruited through invitation and information letters mailed~     to leaders of local chapters of physician organizations, through letters and e-mail sent to~     qualifying general internists in databases, and through e-mail sent to academic physicians~     who practice or teach medicine at medical schools that meet the inclusion criteria. The~     number of participants is estimated at 96 in the first phase of the study. The researchers~     are especially interested in general internists who provide general and preventative health~     care services to patients of various racial, ethnic, and ancestral backgrounds. This study~     will use qualitative methods-focus groups and semistructured interviews-and quantitative~     methods. Two pilot focus group sessions, with about eight members each, are planned for~     Washington, D.C. Other settings for the study are Atlanta, Detroit, Los Angeles, and~     Philadelphia. Those locations were selected based on population density, availability of~     several teaching hospitals with diverse patient populations, availability of physicians~     meeting the study requirements, and the need to address important regions nationwide.~      The focus groups will be separated by region and self-identified race-for example, one group~     consisting of African American internists from Atlanta and another of white internists from~     Atlanta. The facilitator will be a general internist of the same race. Each focus group~     session, to last about 90 minutes, will be audiotaped and transcribed verbatim. Data from the~     focus groups will be analyzed for themes and phrases, and a scale will be developed to assess~     responses. Then the scale will be reviewed by two panels of experts. One panel will be~     experts in genetics and human genetic variation, and the other will be social scientists and~     survey researchers who are experts in developing surveys. For the semistructured interviews,~     two physicians who participated in a given focus group will be invited to participate, based~     on their engagement in the discussion and interest in the project. This will be a~     face-to-face interview of 60 to 90 minutes. A total of 32 interviews will be conducted. After~     the scale is revised, a second pilot study will be done. For that study, 3,500 primary care~     physicians will be invited to participate in a web-based survey by using the scale. It is~     anticipated that there will be sufficient sample size to examine the properties of the scale.~     The proposed timetable for the study is 2 years.~      Benefits from participating in the study include participants' increased understanding of~     human genetic variation and awareness of how other physicians understand and use race and~     ethnicity in their practice of medicine. Also, information gained will be useful to improve~     physicians' training. There will be compensation for participation. Each physician will~     receive $150, and those who participate in both the focus group and semistructured interview~     will receive $150 for each session.~   "
245520|NCT00339911|"~     Background:~      The purpose of this protocol is to establish a centralized repository for the collection and~     distribution of samples (either blood, buccal mucosal cells, semen, urine, or nail clippings)~     from paid, healthy volunteer donors for in vitro research conducted by NCI Frederick~     Investigators.~      Objectives:~      Research uses of normal donor samples obtained through this protocol will include but not be~     limited to genotype analysis, immune function studies, drug screening, vaccine development,~     method development, quality control testing of reagents, and the propagation of infectious~     agents, including HIV.~      Although samples may be used to screen for genetic polymorphisms, this protocol will not be~     used to conduct genetic screening, or other types of studies, specifically designed to reveal~     information of known clinical relevance or implication. Further, Investigators wishing to~     recontact donor(s) for repeated samples when preliminary work has given rise to a research~     question of potential clinical relevance will seek IRB guidance on whether a separate,~     specific protocol should be initiated.~      Eligibility:~      Healthy FCRDC employees will be recruited. Potential donors will be excluded if screening~     indicates exposure to HIV, HTLV or Hepatitis C virus or Hepatitis B virus infection.~      Study Design:~      Samples provided to Investigators will be either anonymous or coded, depending on the~     specific need.~      Codes will be securely maintained and under no circumstances will donor identity be released~     to Investigators.~      The investigational nature of the studies in which their specimens will be used, and the~     risks and discomforts of the donation process will be carefully explained to the donors, and~     signed informed consent documents covering study participation and HIV testing will be~     obtained.~      Donors will receive financial compensation for their time, discomfort and inconvenience~     according to an established schedule; compensation for blood donation is based on the volume~     donated.~      Investigators requesting to participate in the Research Donor Program (RDP) by receiving~     samples for research use will be required to submit a written memo of request, briefly~     describing the nature of the research and providing assurance that samples provided through~     this protocol will be used solely for in vitro research.~      Whole blood will be collected by the standard phlebotomy technique of venipuncture of forearm~     veins.~      Buccal mucosal cells will be collected by use of a sterile swab or brush or after oral rinse.~     Semen will be collected by self-masturbation at the donors homes.~      Urine and nail clippings can be collected either in donors homes or at OHS.~   "
245589|NCT00338988|"~     This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine~     (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma,~     including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic.~     Participants may be either previously untreated or treated with chemotherapy. Participants~     will accrue to two strata based on pre-treatment status; separate response rates and~     statistical operating characteristics will be applied to each stratum.~      The primary objective is to determine the objective response rate (complete plus partial) of~     XELOX in this population.~      Secondary objectives include determining toxicity, stable disease rates, and median and~     overall survival of participants treated with this combination.~   "
245521|NCT00339898|"~     This study will determine whether the results of a test called reverse~     transcriptase-polymerase chain reaction (RT-PCR) correlate with clinical outcomes in patients~     with Ewing sarcoma, and if they can be used to help identify patients at high risk for~     metastasis (spread of the cancer beyond the original site).~      This is a companion study to another NCI trial (AEWS0031), which is examining the~     effectiveness of an intensified chemotherapy regimen for patients with Ewing sarcoma. The~     primary purposes of AEWS0031 are to determine: 1) if chemotherapy given every 2 weeks can~     cure more patients with Ewing sarcoma and similar tumors than chemotherapy given every 3~     weeks; and 2) if certain biological characteristics of these tumors can predict how well the~     chemotherapy will work.~      Many, but not all, patients with Ewing sarcoma that has not metastasized can be cured with~     standard radiation, surgery, and chemotherapy treatment. Most patients whose tumors have~     spread, however, are not cured with standard treatment. A goal of future therapy is to~     identify patients at highest risk for metastasis so that they can be given more intensive~     therapy, and, conversely, patients at lower risk of relapse can receive less toxic treatment.~      Patients enrolled in AEWS0031 are eligible for this companion study. No additional procedures~     re required; RT-PCR testing will be performed on blood and bone marrow samples collected for~     AEWS0031.~   "
245522|NCT00339885|"~     The aim of the project is to positionally clone susceptibility genes for NIDDM. Patients will~     be ascertained in Finland from previous health surveys and hospital discharge records.~     Approximately 400 affected sib pairs will be collected. Families will be chosen who have, at~     most, one parent with NIDDM no history of IDDM. A clinical examination will be undertaken on~     family members and blood drawn for DNA isolation. Covariates such as body weight, blood~     pressure, lipid levels and urinary albumin will also be measured. The unaffected spouse and~     children of a subset of probands will be invited to undergo a frequently-sampled intravenous~     glucose tolerance test (FSIGT) to measure parameters of pancreatic function and peripheral~     insulin resistance (IR). A number of unrelated elderly non-diabetic subjects will also be~     identified to conduct a population-based association analysis.~      The FSIGT analysis will be performed in Los Angeles. The DNA will be shipped to Bethesda~     where a total genomic scan will be performed using semi-automated fluorescence-based~     genotyping technology. Data from Bethesda, Los Angeles and Finland will be sent to Ann Arbor~     where parametric and non-parametric methods will be used to analyse both discrete traits such~     as NIDDM and intermediate traits like IR.~   "
245523|NCT00339872|"~     The purpose of this study is to evaluate the safety of, and blood drug levels for, single,~     ascending doses of IMA-638 in mild to moderate asthma subjects.~   "
245524|NCT00339859|"~     The Laboratory of Human Carcinogenesis and the Pharmocogenetics Section of the Genetic~     Epidemiology Branch will conduct a lung cancer case-control study in Baltimore, Maryland. The~     primary hypothesis of the study is to determine if mutagen sensitivity, p53 induction and~     apoptosis in cultured lymphocytes will be predictive of lung cancer risk. While there are~     some studies that examine mutagen sensitivity, none of these assays has been well-studied in~     an epidemiological setting. Because of methodological issues described herein, and the~     proposed development of new assays, this study will be viewed as a pilot and therefore~     hypotheses generating. The design of this molecular epidemiology study has been specifically~     developed to test the reliability and validity of the mutagen sensitivity assay, where a~     case-control study is needed to assess the possibility of case bias (i.e., results vary due~     to the concurrent presence of lung cancer rather than risk). Importantly, this protocol will~     establish a resource that will allow for the validation of these assays and also for the~     study of other biomarkers and gene-environment interactions, especially those related to DNA~     repair. Th secondary goals of this study are to 1) demonstrate gene-neuro-behavioral~     interactions for smoking addiction in controls and 2) assess the relationship of sex-steroid~     metabolism an and estrogen exposure to lung cancer risk. Cases will have histologically~     confirmed lung cancer and reside in Baltimore an and surrounding areas. They will be~     identified through six hospitals in Baltimore. Cases will be recently diagnosed and blood~     will be collected prior to chemotherapy or radiation therapy. Because of this requirement to~     obtain samples before treatment (or for surgical cases at least two months after surgery), we~     recognize that case ascertainment will be reduced, but critical data to assess differences~     between eligible and ineligible subjects will be collected through tumor registries. Two~     control groups will be used, the first will be hospital-based (frequency matched by age,~     gender, race, smoking and hospital) and the second will be population-based (frequency~     matched by age-, gender and race). The first control group will allow us to examine risk~     factors for lung cancer independent of smoking (odds ration for smoking = 1.0), and the~     second will allow the results to be extrapolated to the general population and also will be~     used to validate the phenotyping assays. The strategy for recruitment will allow us to~     over-sample for women and African Americans, so that after examination of data for the entire~     study group, we can assess differences by these subgroups. Cases and controls will receive a~     structured, in person interview assessing prior medical and cancer history, tobacco use,~     alcohol use, current medications, occupational history, family medical history, menstrual~     history and estrogen use, recent nutritional supplements and caffeine intake, and~     socioeconomic status. The questionnaire also will include the Fagerstrom index for nicotine~     dependence (FTND), Center for Epidemiologic Studies Depression (CES-D) scale, and a modified~     version of the Horn-Waingrow Reasons for Smoking (RFS) Scale. The phenotypic markers to be~     studied will assess DNA repair with cellular response by using lymphocyte cultures exposed in~     vitro to radiation, bleomycin, benzo(a)pyrene-diol-expoxide and N-methyl-nitrosurea and then~     measuring induction of chromosomal aberrations, p53 induction and apoptosis. DNA from cases~     and controls also will be used for genetic polymorphism analysis of carcinogen metabolism,~     and those relating to the dopaminergic system and nicotinic receptors. Tumors from cases will~     be evaluated for estrogen and progesterone receptors. The target accrual number of total~     subjects will be 1,200 where there will be 100 cases for each combination of gender and race~     (Caucasian- and African Americans), matched to 100 each of the hospital-based and~     population-based controls.~   "
245525|NCT00339846|"~     This study will determine whether all patients with craniofrontonasal syndrome (CFNS) have a~     mutation of a gene called ephrin-B1 (EFNB1). CFNS is one of a group of conditions called~     craniosynostosis syndromes that result from closure of one or more of the fibrous joints~     between the bones of the skull before brain growth is complete. Because of the premature~     closure, the brain is not able to grow in its natural shape; instead, there is growth in~     areas of the skull where the joints have not yet closed. In CFNS, it results in malformation~     of the skull and face. It is known that the EFNB1 mutation can cause CFNS, and this study~     will see if the gene change is present in all patients with the disorder.~      This study includes patients and family members affected with CFNS. Participants have 1 to 2~     teaspoons of blood drawn for genetic studies. A second blood sample may be requested for~     further research. Some blood may be used to establish a cell line for later studies. This~     involves growing the white blood cells from the blood sample. The cells can be kept in the~     laboratory to make more DNA or can be frozen for later use in studies of craniosynostosis.~     Patients may also have their medical records reviewed to relate gene changes to clinical~     features in CFNS.~   "
245526|NCT00339833|"~     This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine~     whether reducing subclinical inflammation lessens insulin resistance in healthy, obese~     volunteers. The study findings may lead to new strategies for preventing type 2 diabetes. In~     diabetes, blood sugar is higher than normal and can result in serious medical problems, such~     as blindness and kidney failure. People with subclinical inflammation-inflammation that does~     not produce symptoms, such as fever, pain, or skin redness-are at increased risk for~     diabetes. Although the reasons for this are not completely understood, it is known that~     subclinical inflammation exacerbates insulin resistance, which is a cause of diabetes.~     Insulin is a hormone that helps control blood sugar, and when it does not work properly, the~     condition is known as insulin resistance.~      Normal, healthy volunteers between 18 and 45 years old with a body mass index of at least 30~     kg/m2 and who have subclinical inflammation (determined by blood tests) may be eligible for~     this study. Candidates must be non-smokers and must not have an alcohol or drug problem.~     Candidates will be screened with a medical history and physical examination,~     electrocardiogram, and blood and urine tests. Participants will maintain a standard diet and~     undergo tests and procedures during a 14-day inpatient stay at the Phoenix Indian Medical~     Center.~   "
245527|NCT00339807|"~     Human T-lymphotrophic virus type I (HTLV-I) is endemic in southern Japan and the Caribbean,~     but disease manifestations differ across geographic regions. Though age, gender, and route of~     infection may determine the natural history of this infection, the observed geographic~     differences also may, in part, reflect the distinct genetic background of the host as~     evidenced by the distribution of human leukocyte antigens (HLA) and the presence of other~     environmental factors.~      Studies already completed or ongoing have shown notable differences in incidence and~     prevalence of HTLV-I associated diseases and underscore the need for comparative studies and~     analyses in these areas. This prospective new study of blood donors in Jamaica provides us~     with an opportunity to address many hypotheses regarding HTLV-I transmission and pathogenesis~     in the Caribbean in comparison with an ongoing cohort study of HTLV-I carriers in Japan.~      This study will~        -  identify host factors associated with HTLV-I carrier status and HTLV-I pathogenesis.~        -  directly calculate the incidence of HTLV-I associated diseases in this population.~        -  examine the role of HTLV-I in the pathogenesis of other common infectious agents.~      Approximately 5,000+ blood donors who came to the National Blood Transfusion each year will~     be screened for HTLV-I serology. Of those who agreed to participate, all HTLV-I carriers and~     age-, and sex-matched HTLV-I-negatives will be invited to the University of the West Indies~     clinic for a full study enrollment. Study participants will be given a standardized~     questionnaire, a full physical examination, and a phlebotomy (25-30 mL), and will be followed~     every other year for interim health status and additional phlebotomy. All subjects will~     receive an ophthalmologic examination for detection of uveitis and other ocular diseases.~     Some subjects will be further referred to a neurologist, hematologist or dermatologist,~     according to their signs and symptoms. Approximately 1200 HTLV-I carriers and 600 HTLV-I~     negatives will be recruited for a longitudinal follow-up over the next 5-year period. Two~     types of analyses will be conducted: comparison of HTLV-I-positive and HTLV-I-negative~     subjects, and comparison among HTLV carriers between those with a high level of viral load~     and those with a low level.~   "
246751|NCT00323297|"~     To assess the efficacy and safety of sildenafil when added to patients with PAH who are~     taking bosentan as all or part of their background therapy.~   "
245528|NCT00339794|"~     This study, conducted by the American Academy of Family Physicians (AAFP) and the National~     Human Genome Research Institute, will characterize family physicians' attitudes and practices~     related to the genetics of complex disorders. As the front line of care for most Americans,~     family medicine will have a central role in seeing that new findings in genetics lead to~     disease prevention and health improvements. The information gained from this study could be~     useful in understanding and shaping the dissemination of genetic medicine in ways that~     improve the standard of primary care practice.~      Members of the AAFP will be randomly selected from the organization's membership records to~     be invited to participate in this two-phase study. The first phase is a web-based survey of~     AAFP members. In the second phase, a sub-sample of those who complete the survey will be~     re-contacted; half will be members who have enrolled in a year-long web-based curriculum~     related to medical genetics, and the other half will be those who have chosen not to enroll~     in the curriculum.~      Survey questions relate to the physicians' practices, knowledge, and opinions about~     implications of genomic medicine. Survey areas include family history taking; opinions about~     the future of genetics and family medicine; information about the physician and his or her~     practice; and physician's skills, attitudes and knowledge.~   "
245529|NCT00339781|"~     This study, conducted at St. Bartholomew's Hospital, London, England, will determine whether~     cells passed from mother to offspring during pregnancy increase or decrease the child's risk~     of developing type 1 diabetes. Previous research has shown that certain cells that can be~     passed from mothers to their children during pregnancy may affect the child's chance of~     developing other autoimmune diseases. The cells from the mother may persist in the child's~     blood for years after birth and stimulate the child's immune system in such a way that may~     either increase or decrease the chance of the child developing diabetes. This study will~     determine whether these cells are present in identical twins, where only one of the twins has~     type 1 diabetes.~      Participants in the British Diabetic Twins Study in England may be eligible to participate.~     Of each twin pair in the study, one must have type 1 diabetes and the other must be free of~     the disease. The twins' mother must be alive and willing to provide a blood sample. For~     female twins only, their children must be alive and willing to provide either a blood or a~     buccal cell sample (cheek swab).~      Participants undergo the following procedures:~        -  Both twins in each twin pair provide a blood sample collected on a single occasion.~        -  The mother of each twin pair provides a blood sample collected on a single occasion.~        -  Children of female twins provide a single sample from either the mouth or blood. For~          children younger than 12 years of age, a cell sample is collected from the inside of the~          mouth (buccal) using a toothbrush. The child strokes the inside (cheek) of the mouth~          with the toothbrush ten times on each side, spits this into a collection vial,~          immediately rinses the mouth with water and adds this rinse to the sample collection~          vial. Children over 12 years of age may provide either a buccal cell sample or a blood~          sample.~   "
245530|NCT00339768|"~     The Division of Cancer Epidemiology and Genetics is conducting a collaborative randomized~     multi-intervention trial with the Beijing Institute for Cancer Research to evaluate the~     etiologic role of Helicobacter pylori, garlic, and certain micronutrients in the multi-step~     process of gastric carcinogenesis. The primary endpoint will not be cancer, but rather the~     precancerous lesions severe chronic atrophic gastritis, intestinal metaplasia, and dysplasia.~     The study is designed to detect a stabilizing or mild decrease in the expected age-related~     progression of precancerous lesions over the course of the trial. Thus the trial can be~     considered a study of the potential inhibitors of the process of gastric carcinogenesis. The~     trial will also provide an evaluation of therapy for H. pylori, including an assessment of~     reinfection rates, a critical need for formulating strategies for infection control in China~     and other developing countries. Participating in the trial are approximately 3400 adults aged~     35-70 who were part of an ongoing survey of precancerous gastric lesions in 13 Linqu villages~     in Shandong Province. Linqu appears to be an ideal setting for the trial since stomach cancer~     rates are among the highes in the world, precancerous gastric lesions are prevalent, and the~     population is stable and well characterized. These individuals will be randomly assigned~     (taking H. pylori positivity into account) into 8 intervention groups according to a 2(3)~     factorial design. The interventions are: 1) initial treatment of H. pylori infection with~     ameprazole and amoxicillin followed by 2) daily supplementation with a combination of~     alpha-tocopherol, vitamin C, and selenium; and 3) daily supplementation with garlic extracts.~     No serious side effects have been seen from any of the interventions to date. The study staff~     will continue to monitor for possible adverse reactions and the population will receive~     routine medical care follow-up throughout the course of the trial.~      As part of the ongoing study in Linqu, all participants received an endoscopic exam in the~     fall of 1994. Repeat gastroscopic exams with biopsies at 7 standard gastric sites will be~     conducted during March to May, 1999 and March to May, 2003 to detect early cancers and to~     evaluate gasatric mucosal status. The subjects will be categorized according to the most~     advanced lesions detected in all biopsies and assigned a severity score. The three major~     endpoints for analysis will be: 1) prevalence of dysplasia or cancer 2) prevalence of sever~     chronic atrophic gastritis, intestinal metaplasia, dysplasia, or cancer; and 3) average~     severity score....~   "
245531|NCT00339742|"~     This study, sponsored jointly by the National Cancer Institute and the Tehran University of~     Medical Sciences, will explore the causes of cancers of the stomach and esophagus (the tube~     that runs between the mouth and the stomach) in Northern Iran. This is a unique area of study~     for the following reasons:~        -  Some of the highest rates of esophageal cancer in the world have been reported in~          northeastern Iran 109 cases per 100,000 men and 175 cases per 100,000 women each year~          about 40 times higher than the rates of this cancer in the United States.~        -  In this area of Iran, unlike most areas of the world, the disease affects more women~          than men.~        -  Within 300 miles along the southern border of the Caspian Sea, the rates fall to 10~          cases per 100,000 people per year.~      The high rates of disease in this area, the unique geographic distribution of cases, and the~     exceptionally high rate in women make Northern Iran a promising site for studying esophageal~     and stomach cancers.~      Patients 30 years of age and older who are referred to the upper gastrointestinal disease~     Atrak Clinic in Gonbad, Golestan Province, Iran, with suspected esophageal cancer may be~     eligible for this study. In addition, control subjects 30 years of age and older with certain~     specified diseases will be recruited from patients referred to four hospitals in Gonbad and~     to the Taleghani Clinic. After giving informed consent, all participants will undergo the~     following procedures:~        -  Interviews, including questions about age, ethnicity, education, and other demographic~          data; habits, such as tobacco, opium, and alcohol consumption; personal and family~          medical history; diet, with special attention to food preservation, cooking methods, and~          drinking water; physical activity; occupational and residential history; body~          measurements; signs and symptoms of upper gastrointestinal disease; oral hygiene; animal~          contact; transfusion history; and family socioeconomic status.~        -  Blood draw (15 milliliters, or 1 tablespoon) for genetic and chemical testing for~          markers that may predict who gets the disease.~        -  Hair and nail sampling to identify minerals or compounds whose exposure may be related~          to esophageal cancer.~        -  Endoscopy to evaluate the health of the esophagus and stomach. This test will be~          performed on all case patients and on control participants who give their permission.~          Before the examination, the subject will swallow a liquid that numbs the throat and may~          be given a medicine through a vein to promote drowsiness. The subject will then swallow~          a tube (endoscope) through which the doctor can look at the esophagus and stomach and~          take samples of tissue to look for disease. The tissue samples will be examined~          microscopically and will then be stored for possible future genetic or other testing~          related to diagnosing or determining the risk of esophageal cancer.~   "
245532|NCT00339729|"~     We propose a population-based case-control study among 7000 elementary school children in~     semi-rural Johnston County, NC. Teachers will complete a screening form on each child.~     Controls will be randomly selected. Mothers of potential cases and controls will be~     interviewed by telephone about their child's symptoms of ADHD and exposure history, their~     family history of ADHD, and their reproductive and exposure history. Children's shed baby~     teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child~     Behavior Checklist. School records will be collected. The study goals are to identify risk~     factors for ADHD including preterm delivery and childhood lead exposure.~   "
245590|NCT00338975|"~     This study evaluated the effectiveness of Cognitive Behavioral Social Skills Training versus~     goal-focused supportive contact in improving social functioning in people with schizophrenia.~   "
245604|NCT00338793|"~     Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids~     are used for tuberculous pleurisy because their anti-inflammatory effect is thought to~     minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to~     evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with~     tuberculous pleurisy.~   "
245533|NCT00339716|"~     Iodine-131(131I) and other radioisotopes of Iodine are contained in fallout from atmospheric~     nuclear weapons tests and are among the radionuclides most likely to be released in a nuclear~     reactor accident. In spite of nearly 50 years of experience, the risk of thyroid disease,~     especially thyroid cancer, attributable to exposure to 131I remains unknown, although the~     carcinogenic potential of x-ray and gamma-ray exposure of the thyroid is reasonably well~     known. The available data also indicate that children face greater risks of radiation-induced~     thyroid cancer than do adults.~      The nuclear power plant accident at Chernobyl released large quantities of 131I and other~     radioisotopes of iodine into the atmosphere, contaminating thousands of square kilometers and~     exposing millions of people. It is proposed that a well-defined subset of Belarussian~     children aged 0-18 years at the time of the accident be examined by well-trained specialists~     for thyroid disease at least biennially for up to 30 years. A cohort of 15,000 children has~     been identified, all of whom had their thyroids measured for radioactivity during the weeks~     immediately following the accident. Under a rigid research protocol these children will~     receive complete diagnostic thyroid examinations, including palpation, ultrasound scanning,~     thyroid hormone and other laboratory tests, and fine-needle aspiration, as appropriate.~     Cancer will be determined by expert pathology examination of tissue. In addition to the~     analysis of thyroid radiation measurements made in May-June, 1986, efforts will be made to~     reconstruct each person's exposure and to estimate the radiation doses to the thyroid. This~     will involve the reconstruction of deposition patterns and environmental pathways of the~     radioiodines, and of the location, dietary characteristics, and lifestyle of each person~     throughout the exposure period.~      The data will be analyzed to evaluate the relationship, if any, between thyroid disease,~     especially cancer, and the radiation dose to the thyroid, with emphasis on the dose from~     131I. The primary focus will be on dose-response analyses of person-year incidence data with~     stratification by sex, age at exposure, geographic area, time, and age at risk. Confounding~     factors, e.g., use of potassium iodide (KI) as a prophylactic measure, will be evaluated and~     controlled in the analysis, and the uncertainty of the dose estimates will be taken into~     account.~      In addition to producing risk coefficients for thyroid cancer and other thyroid diseases in~     children as a function of sex and age at the time of exposure, it is expected that the~     analyses will contribute new knowledge of the carcinogenic effectiveness of 131I in~     comparison with that of x-ray and gamma radiation. This information will fill a major gap in~     the world's knowledge of radiation effects, and will provide guidance for radiation~     protection and public health policies wherever nuclear reactors are in operation....~   "
245534|NCT00339703|"~     The purpose of this study is to determine whether serum resistin levels in asthmatics are~     elevated. We will recruit subjects from the allergy/immunology clinic with a prior diagnosis~     of moderate to severe persistent asthma in addition to subjects being seen for evaluation of~     drug allergies. Based on the inclusion and exclusion criteria below, subjects will be placed~     into a control and asthma group. Each subject will undergo one blood draw in the main lab at~     WHMC, and return a lavender top tube to the allergy/immunology clinic for the EIA resistin~     assay. The patient will then have a brief encounter with a physician to determine an up to~     date history of asthma symptoms prior to participating in the exhaled NO test. The entire~     subject encounter will take place with one clinic visit, and requires no follow up visits as~     part of the study. The greatest risk to each subject will be the blood draw, as the exhaled~     NO is a completely non-invasive test.~      Plasma from each subject will be stored in a –70° freezer for no more than one month. Samples~     will be analyzed for resistin levels using an EIA assay run monthly. Mean values from serum~     CRP, serum glucose, serum resistin, and exhaled NO will be compared using a students T-test.~   "
245535|NCT00339690|"~     This study will determine whether use of an in-home test kit results in decreased dust mite~     allergen levels in homes of children who are sensitive or allergic to dust mites. Dust mite~     allergens come from dust mites - microscopic spider-like animals that feed on house dust.~     Dust mites are common anywhere there is dust, such as in carpeting and beds. Some people are~     allergic to dust mite allergens and may develop asthma from living near them.~      People who live in the Research Triangle Park area of North Carolina who have a child between~     5 and 15 years old with a dust mite allergy or sensitivity may be eligible for this study.~     Participants must plan to remain in the same house for at least 12 months from the start of~     the study. At least half the floor of the child's room must be carpeted.~      Participants are given materials on how to reduce dust mite allergens in their home. Study~     staff visit participants' homes three times over a 12-month period to ask questions about the~     home, home cleaning habits, and participants' experiences with home test kits (see below) for~     measuring dust mite allergen. At each visit, staff collect dust samples from the child's~     bedroom, the parents' bedroom, and the living room. The dust samples are analyzed in the~     laboratory for dust mite allergens and the results are given to the participants at the end~     of the study.~      Participants are also given four home test kits for measuring dust mite allergen in the home.~     At the first home visit, staff instruct the participants on how to use the kits and answer~     any questions they may have. The kits are mailed at certain times during the study for the~     participants to use to measure allergen and send the results to the study investigators in a~     pre-paid addressed envelope.~      A control group is given educational materials but no test kits.~   "
245536|NCT00339677|"~     This study will evaluate the structure of error in self-reporting instruments on diet, in~     following up the Observing Protein and Energy Nutrition Study (OPEN) conducted in 1999 and~     2000. The OPEN study, the largest of its kind, resulted in a wealth of nutritional biomarker~     data-measurable indicators of changes in organisms at the level of molecules or cells. A~     biomarker could help in understanding how environment and disease are related and about~     disease risks. Furthermore, its findings showed that the relative estimates of disease risk~     may be weakened by a food frequency questionnaire and a 24-hour questionnaire. Scientists~     have long recognized that self-reported information from questionnaires and interviews~     contains errors, but there has been uncertainty about the structure of such errors. For the~     proposed study, a food record and a food checklist-adjusted food frequency questionnaire will~     be compared with the previously used questionnaires, to determine whether the newer study~     instruments present less chance of measurement error. The results may provide better tools~     for a study on nutritional epidemiology, that is, the incidence and other aspects of disease~     and nutrition. OPEN study participants will be invited for follow-up.~      Patients who completed the 1999-2000 study who are not currently pregnant or a liquid weight~     loss diet may be eligible for this study. The original study recruited men and women 40 to 69~     years of age. A letter with summary results from the original OPEN study will be sent to each~     of the 482 participants.~      Both the Food Record and the food checklist, called the Daily Food List, are instruments to~     be given. The Food Record asks the participant to record all foods and beverages consumed.~     The Daily Food List asks respondents to write in to the number of times a limited number of~     food categories are consumed. In addition, respondents will be asked to complete the National~     Cancer Institute Diet History Questionnaire (DHQ), identical to the one that they completed~     in the original OPEN study, regarding the previous 12 months. Participants will randomly be~     assigned to one of two groups. All will receive four study mailings over a 3-month period:~     the DHQ, First 4-Day Food Record (4-day FR), Second 4-day FR, and Booklet of 7-Day Food Lists~     (7-day FL), the latter listing selected foods that the participants will mark if consumed on~     the reporting day. Study Group A will receive the DHQ, first 4-day FR, second 4-day FR, and~     7-day FL. Study Group B will receive the DHQ, 7-day FL, first 4-day FR, and second 4-day FR.~     Within 10 days after receiving the DHQ, participants will be called to schedule an~     appointment for a 30- to 45-minute visit. Participants will undergo the following procedures:~        -  Complete the Physical Activity Questionnaire (by telephone for those who have moved out~          of the local area or are unable to attend the visit)~        -  Have weight measured~        -  Be asked about whether he or she has recently developed certain medical conditions,~          experienced dramatic changes in diet, or gained special education in nutrition~      The completion time for each instrument in dietary assessment is approximately as follows:~        -  DHQ-60 minutes.~        -  Each 4-day FR-80 minutes (20 minutes a day).~        -  7-day FL-35 to 49 minutes (5 to 7 minutes a day).~   "
245537|NCT00339664|"~     Cancer patients in clinical trials donate various human samples (e.g., serum, plasma, blood,~     urine, feces, bile, saliva) for research purposes.~      The purpose of this study is to conduct further analyses on these existing samples from~     clinical trials that are being performed outside of, but in collaboration with, the National~     Cancer Institute.~   "
245538|NCT00339651|"~     This study, conducted jointly by the National Cancer Institute and the Kaiser Permanente~     Center for Health Research Northwest (KPCHRN) in Portland, Oregon, will lay the groundwork~     for a future study to identify precursors of endometrial cancer; that is, conditions that~     precede development of cancer of the lining of the uterus. The diagnosis of endometrial~     hyperplasia (a condition of abnormal proliferation of endometrial tissue) includes most~     precursors of endometrial cancer, as well as many benign conditions. Currently, three methods~     of classifying endometrial cancer precursors have been suggested based on endometrial~     hyperplasia findings, but it is not known which classification best predicts cancer risk.~      This study will examine surgical specimens of hyperplasia and cancer from women diagnosed~     with endometrial cancer at least 2 years after a diagnosis of endometrial hyperplasia.~     Investigators will estimate the percentage of cases with different degrees of hyperplasia,~     and assess the subsequent cancers that developed. This will allow them to rank hyperplasia~     lesions according to cancer risk and identify lesions that represent the most immediate~     cancer precursors. They will also review patients medical charts for information related to~     cancer risk and treatment.~      Study participants will include women enrolled in the KPCHRN who are 40 years of age or older~     and who were diagnosed with endometrial cancer at least 2 years after being diagnosed with~     endometrial hyperplasia.~   "
245605|NCT00338780|"~     The aim is to investigate whether Lamivudine 100mg daily is effective in the long term~     treatment of HBeAg negative chronic HBV infected patients with active liver disease in Asia~   "
245606|NCT00338767|"~     This study will evaluate the effectiveness of directly observed therapy plus antidepressant~     medication in improving adherence to antiretroviral drug therapy among HIV-infected homeless~     and marginally housed people with depression.~   "
245539|NCT00339638|"~     This study will identify chemical and protein markers in the blood of people who carry the~     human T-lymphotropic virus type I (HTLV-I), a virus associated with various pathologies,~     including an increased risk in adults of a rare and aggressive cancer called adult T cell~     leukemia/lymphoma (ATL). The study will also examine differences in these markers before and~     after the onset of ATL.~      ATL has been reported in every area where HTLV-1 is common, including the Caribbean and parts~     of Japan, West Africa, the Middle East, South America, and Pacific Melanesia. Risk factors~     for the disease are largely unknown and seem to vary among those affected in different~     endemic regions. People who acquire the infection early in life are thought to be at higher~     risk than those who are infected later. In Japan, men seem to be at greater risk than women,~     but the same is not evident among the black population in the Caribbean and Brazil.~      Findings from this study will increase understanding of the cause of ATL and identify~     differences in tumor characteristics and the course of disease across geographical areas.~      Study subjects are drawn from among participants in eight studies of HTLV-1 carriers,~     including the 1) Jamaica Mother-Infant Cohort Study, 2) Jamaica Family Study, 3) Jamaica Food~     Handlers Study, 4) Miyazaki Cohort Study in Japan, 5) Nagasaki Cohort Study in Japan, 6)~     Japan Public Health Center-based Prospective Study on Cancer and Cardiovascular Disease, 7)~     HTLV Outcome Studies in the United States, and 8) GIPH Cohort Study in Brazil.~      Stored blood samples previously collected from patients in the above studies who did and did~     not develop ATL will be analyzed for immunologic and genetic factors.~   "
245540|NCT00339625|"~     The primary objective of the Poly Prevention Trial (PPT) is to determine whether a low fat,~     high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous~     polyps of the large bowel. Secondary objectives of the PPT include 1) evaluating the~     effectiveness of the intervention program with respect to participant achievement of dietary~     goals; 2) examining the relation of dietary change and biochemical markers in blood; and 3)~     assessing the impact of the intervention on quality of life indicators.~   "
245541|NCT00339612|"~     This is an observational, prospective cohort study to describe the demographic, clinical,~     immunologic, and virologic characteristics of HIV-infected children at participating clinical~     sites in Latin American countries. Enrollment in this study will consist of approximately 500~     HIV-infected children in two cohorts who acquired HIV infection through mother-to-child~     transmission (MTCT). The first group will be a static cohort consisting of HIV-infected~     children who were five years of age or younger when previously enrolled into the NISDI~     Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled,~     HIV-infected children who are five years of age or younger. We will characterize~     complications from both the disease and its treatments. Subjects will be evaluated every six~     months for approximately five years and assessments of growth, morbidity, disease progression~     and mortality will be made.~   "
245542|NCT00339599|"~     This study, conducted in collaboration with the Johns Hopkins University School of Medicine,~     will explore the genetic influences on susceptibility to atherosclerotic cardiovascular~     disease (ASCVD). Atherosclerosis is a chronic narrowing of the arteries caused by an~     incremental buildup of fatty substances on the linings of walls of arteries. This study will~     examine the role of genes related to the inflammatory process on the incidence of ASCVD and~     on levels of chemokines (proteins involved in inflammation).~      DNA samples, chemokines levels and relevant clinical data from patients enrolled in Johns~     Hopkins's sibling and family heart studies are analyzed for specific gene markers. The~     studies include: Nurse Model in Black Families at Risk for Heart Disease; Genotypic~     Determinants of Aspirin Response in High Risk Families; and Coronary Disease Detection by~     Thallium SPECT and Fast CT. All of the enrolled patients have consented to have their DNA~     used for testing of genetic factors that may predict cardiovascular disease and do not~     contain patient identifier information.~   "
245543|NCT00339586|"~     Current chemotherapy for advanced non-small cell lung cancer, not amenable for curative local~     treatment (surgery or chemoradiotherapy), has a modest life-prolonging effect and can improve~     quality of life. There is however no potential for long-term cure for these patients.~      Chemotherapy also produces variable and often significant toxicity. Current retrospective~     evidence suggests that significant clinical responses can be obtained when patients whose~     cancer cells have an EGFR TKD mutation are treated with an EGFR TKI.~      The ease of administration and toxicity profile of TKI compare favourably with that of~     chemotherapy, even single agents such as for example gemcitabine The present study will~     establish the clinical benefit rate of TKI as a first line treatment in patients with EGFR~     mutations and thus estimate the proportion of patients who might benefit for a prolonged~     period from a treatment with a modest toxicity profile.~   "
245544|NCT00339573|"~     We propose to conduct a scientifically valid, descriptive survey to measure the prevalence~     and levels of lead in dust, soil, and paint, and the prevalence and levels of various indoor~     allergens in floor and bedding dust in the nation's housing stock. The survey strategy is a~     population-based, multi-stage area probability sample designed to represent all 50 states.~     The survey will include approximately 1000 homes in at least 100 primary sampling units (PSU,~     a metropolitan area or cluster of counties). Residents of candidate participant housing units~     (HUs) will initially be contacted by a letter to introduce and provide a brief explanation of~     the study. A field interviewer will then visit each candidate HU to screen and recruit~     eligible units into the study. A short Screening Questionnaire will be administered to an~     adult HU resident and an invitation will be extended to those HUs that are eligible to~     participate in the study. A field data collection visit will be scheduled for the following~     week, at the resident's convenience. The collection visit will be conducted by two member~     team (including the same field interviewer that will conduct the screening/recruiting visit)~     and will consist of administration of an informed consent form and Data Collection~     Questionnaire, completion of home observation forms, collection of interior dust and exterior~     soil samples, and conduct of nondestructive paint lead analysis on both interior and exterior~     walls. Soil and dust samples will be shipped to analytical laboratories for lead and allergen~     analysis. Extensive survey design, procedure, and reporting details are provided in the~     National Survey Lead Hazards and Allergens in Housing: Protocol and Sample Design Report~     (Attachment A). It is anticipated that this study will provide allergen-specific data~     regarding: 1) housing conditions, demographic factors, and climate to facilitate evaluation~     of regional, ethnic, socioeconomic, and housing characteristic differences in the indoor~     allergen burden; 2) an estimate of indoor allergen exposure in the U.S. population; 3)~     baseline data that can be used to stimulate future studies which attempt to correlate~     allergen exposure to disease outcome. The study will yield lead hazard data to: 1) estimate~     the number and percent of homes with dust and soil lead levels above selected thresholds; 2)~     identify sources of lead in dust in housing; 3) permit future analysis of lead hazard control~     strategies an costs, including associated policy and regulatory guidelines.~   "
245607|NCT00338754|"~     The purpose of the study is to assess the efficacy and safety of repeated administration of~     adalimumab in adult Japanese subjects with moderate to severe chronic plaque psoriasis.~   "
246054|NCT00332748|"~     The purpose of this study is to determine what effects Esomeprazole (Nexium) has on~     increasing or decreasing the amount of oral taxane in the blood, and to determine the safety~     of oral taxane and effect of oral taxane on the cancer.~   "
245545|NCT00339560|"~     The key aims of this study include estimation of possible risk associated with a history of~     gallstones, bacterial infection for the biliary tract, other medical history, diet, use of~     tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information~     will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients~     with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the~     patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for~     removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo~     surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the~     rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will~     be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial~     antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be~     cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence~     of bacteria infection. A major challenge in biliary tract cancer research is to determine how~     cancer risk factors differ from those for gallstones or biliary duct stone disease, since~     many people have gallstones (or biliary duct stones) but few develop cancer.~   "
245546|NCT00339547|"~     The proposed study is designed to estimate the proportion of 35-49 year-old women in a large~     urban health plan who have had fibroids. The membership of the health plan is approximately~     45% black, so estimates for black and white women can be compared. Risk factors for the~     condition will be studied, and uterine tissue from women having hysterectomies or~     myomectomies will be studied to identify genetic, hormonal, and protein mediators of tumor~     growth.~      A randomly selected sample of about 1800 women age 35-49 who are members of the George~     Washington University Health Plan will be invited to participate. Presence of leiomyomas for~     premenopausal participants with no prior diagnosis of leiomyoma will be determined by an~     ultrasound examination. Presence of leiomyomas for premenopausal women who report a prior~     diagnosis of fibroids will be determined by ultrasound evidence in their medical record when~     available, and by self-report when not available. History of fibroids in postmenopausal women~     will be based on pathology records for those with surgical menopause and on radiology records~     or self-report for the small number of naturally postmenopausal women. Estimates of the~     proportion who have or have had fibroids will be compared for blacks and whites.~      To examine risk factors for leiomyoma we will conduct a case-control analysis. Cases will be~     those women identified with leiomyoma from the random sample, supplemented by women in the~     same age range who have hysterectomies or myomectomies during the study period and hose~     excised uteri show evidence of fibroids on standard pathology examination. Women from the~     random sample with ultrasound or pathology evidence showing no uterine fibroids will~     constitute the control group. Controls will be compared to cases grouped by size of largest~     fibroid and grouped by clinical.~      A telephone interview and self-administered questionnaire will provide information on~     demographic factors, medical history, dietary intake, reproductive history, life style~     factors, and occupational/environmental exposures. Blood will be collected from premenopausal~     women to measure lipids, insulin, and potential susceptibility genes. Urine will also be~     collected from premenopausal women early in their menstrual cycles to measure gonadotropin~     levels. Blood pressure, heart rate, weight, height, and waist-to-hip ration will be measured.~     Tissue from surgical specimens will be use by collaborators at NIEHS to measure cell~     proliferation and apoptosis, genetic factors, estrogen and progesterone receptor levels,~     protein markers of estrogen action, and growth factors.~   "
245547|NCT00339534|"~     This study, conducted at Korle-Bu Hospital in Accra, Ghana, will help elucidate the roles of~     lifestyle and genetic factors in prostate cancer risk. There is a strong variation in risk of~     prostate cancer throughout the world. The rates of the disease among African Americans are~     some of the world s highest. In the United States, the incidence of prostate cancer is 70~     percent higher in African Americans than in white Americans and the death rate in African~     Americans is almost double that of white Americans. The reasons for this excessive risk are~     unknown, but both genetic and lifestyle factors have been suggested.~      Because Africans and African Americans share similar genetic ancestry but have vastly~     different lifestyles, a better understanding of the rates and risk factor profiles for~     prostate cancer among Africans will provide important clues to what causes the disease. This~     study will try to assess the incidence of prostate cancer in the West African nation of~     Ghana. The study has two components:~        -  Clinical survey The methods of diagnosis at Korle-Bu will be evaluated and the incidence~          of prostate cancer over a 5-year period will be estimated.~        -  Screening and detection survey A survey of 1,000 men between 50 and 74 years of age will~          estimate the prevalence of both asymptomatic and undiagnosed symptomatic prostate cancer~          in the Accra population.~      The clinical survey will use data from the cancer logbook and medical records at Korle-Bu~     Hospital and the Ghanaian National Census to derive an estimate of prostate cancer incidence~     within Accra. The estimate will be low, since it will be based only on men diagnosed or~     treated at Korle-Bu and will not include men with asymptomatic disease, men diagnosed~     elsewhere, or men without access to medical care. The screening and detection survey will~     assess the presence of asymptomatic and unrecognized symptomatic prostate cancer using PSA~     testing and digital rectal examination in a random sample of 1,000 men in the general~     population of Accra. This will provide a high estimate of disease prevalence. The two~     estimates will provide an approximation of the true incidence rate of the disease in Accra.~      Comparison of these data with similar data from community surveys of African Americans will~     provide insight into reasons for the excess risk of prostate cancer in African Americans.~   "
245548|NCT00339521|"~     We propose to add a collection of genetic material to a clinical trial of anti-oxidant~     supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public~     pediatric hospital in Mexico City. The anti-oxidant study has been approved by the~     Institutional Review Board of the National Institute of Public Health in Mexico City and is~     scheduled to begin in September 1998. The purpose of this add-on study is to examine genetic~     polymorphisms that may be related to asthma. Asthma cases will be compared with their parents~     as controls. In partaicular, we will save the buffy coat from the blood collection being done~     on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial~     for extraction of DNA. This part of the sample would otherwise be discarded. In addition, we~     will enroll the parents of the asthmatic child as controls for the child. From the parents,~     either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected.~     Although our current plan is to compare the asthmatic child to the parents using statistical~     methods based on the transmission disequilibrium test because research into various family~     designs for candidate gene studies is rapidly evolving and various sibling control sample~     strategies have been discussed, we would also like to collect a genetic sample on as many of~     the child's siblings as possible with priority given to those closest in age. This will~     enhance the future usefulness of the samples. We anticipate enrolling approximately 200~     families.~   "
245549|NCT00339508|"~     The researchers have developed and distributed several software packages for pedigree~     analysis (FAST, CASPAR, PedHunter, IIC) and cancer genetics (oncotree, METREX). Users who~     need assistance with the software or who want to see new features added often send the~     researchers data files that include human data. The information is normally coded, and the~     researchers do not have access to the identification of the people whose information is in~     the files. Sometimes the content of the files gives rise to collaborations between the~     software developers and the providers of the files. Because concerns over the confidentiality~     of medical information have increased significantly over the past few years, the researchers~     must apply for exemptions from detailed ethics committee oversight for every data set they~     receive. This process is cumbersome and makes it difficult to assist software users. The~     amount of information required to apply for an exemption also poses a barrier to~     collaborations.~      A full protocol will subject all data sets to ethics committee oversight without the need for~     individual exemption requests, enabling the researchers to assist users with software~     problems and to collaborate with other researchers.~      From January 1, 2000, through December 15, 2001, the researchers received 71 requests for~     assistance, 19 of which included data files. None of the data files had any names or patient~     identifiers. Of these 19, in 8 cases the researchers sent back modified output files. In two~     of these eight cases, the researchers could see results of research interest; one of them~     concerned human data. In 2 of the 19 cases, the researchers sent back modified input files;~     in one such case, they established a collaboration with the originator of the files. In sum,~     most requests come under the heading of customer service, with no research contents. A few,~     however, do lead to research results or collaborations, for which ethics committee oversight~     is required.~      Over the three-year time frame of this protocol, the researchers anticipate receiving data on~     a maximum of 10,000 individuals. They have modified their software documentation to~     explicitly instruct users to make sure the data files they send have no names. Should they~     receive files with names, they will delete the files and ask the originator to resubmit them~     with names encoded. Users submit data through unencrypted e-mail. The data are stored in~     password-protected computers at the National Institutes of Health.~   "
245550|NCT00339495|"~     The Division of Cancer Prevention and Control (DCPC), under extramural contracts to 10 U.S.~     clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal~     and ovarian cancer (The PLCO Trial). The NCI Executive Committee approved the expansion of~     the PLCO Trial to collect additional materials and to conduct additional studies. About~     74,000 men and 74,000 women, aged 55-74 years, are being randomized on a 50/50 basis into~     screening or usual care arms. Additional blood will be collected from screened subjects and~     saliva for buccal cells from control subjects. Pathologic tissues will be obtained for cases~     that develop cancer or selected related diseases (e.g., colon polyps, benign prostatic~     hyperplasia). Additional questionnaire-based risk information will also be collected.~     Genetic, biochemical and questionnaire-based risk information will be related to the~     development of cancer and other diseases in this population. Volunteers who provide samples~     for these studies will not routinely receive their individual results from the Additional~     Investigation. Subjects requesting such information, however, will be provided their test~     results. This protocol Review Application is for the collaboration of intramural scientists~     in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies.~   "
245551|NCT00339482|"~     This project is a continuation of an extensive longitudinal population-based epidemiological~     investigation of the etiology and determinants of type 2 diabetes (and its complications) and~     formerly arthritis. The original baseline observations were made on the residents of the Gila~     Indian Reservation, predominantly Pima Indians, in 1965. We attempt to reexamine the~     population at two-yearly intervals, and have continued to recruit new respondents who,~     because of age and residence or familial relationships, become eligible for entry into the~     project. Eligible persons receive a battery of standardized examinations related to diabetes~     and its complications at two-yearly intervals, including a glucose tolerance test,~     biochemical determinations, such as serum cholesterol and creatinine, insulin, etc., a~     physical examination, and in those aged 15 years and above, retinal photographs, and an~     electrocardiogram. Persons known to have diabetes will be asked to undergo the examination at~     annual intervals to enable more complete and accurate documentation of their health status~     and to identify the development and progression of complications of the disease.~      The data collected have been used to describe the natural history and determinants of~     diabetes and its complications, to investigate factors relating to the etiology of these~     diseases and investigate the genetics of diabetes, its complications and other phenotypes. In~     addition, the project serves to identify subjects with specific characteristics for the~     clinical research projects carried out by the Obesity and Diabetes Clinical Research Section~     and the Diabetes Epidemiology and Clinical Research Section fo the Branch.~   "
245552|NCT00339469|"~     This study, sponsored by the National Cancer Institute and Penn State University, will~     examine how a diet high in legumes (dried beans) influences risk factors for colon cancer and~     polyps. Many scientists believe that colon and rectal cancers develop from polyps (tumors of~     the lining of the large bowel). This study will test whether a high-legume diet can reduce~     levels of certain factors (blood insulin, blood glucose, and markers of inflammation such as~     C-reactive protein) that at elevated levels are known to increase the risk of colorectal~     polyps and colon cancer.~      Healthy men between 35 and 75 years of age may be eligible for this study, conducted at Penn~     State University in University Park, Pennsylvania. Candidates are screened with blood tests~     and measurements of height, weight, and blood pressure. All candidates must have had a~     colonoscopy within 2 years of entering the study. They may or may not have had adenomas and~     may or may not be insulin-resistant. Candidates must not have cancer, heart disease, kidney~     disease, diabetes, or other serious medical condition, and they must have no history of~     colorectal cancer, polyp removal, bowel surgery, polyposis syndrome, or inflammatory bowel~     disease. Participants undergo the following tests and procedures:~        -  Caloric requirement testing: The subject's resting metabolic rate is measured while~          fasting and in the early morning at rest to determine daily calorie requirement before~          beginning the study diet. A special clear plastic hood is placed over the subject's head~          while his breathing is measured. He can communicate with the technician at all times~          during the 30-minute test.~        -  Study diet: Subjects follow two required 4-week diets with a 3-week break in between,~          followed by an optional third 4-week diet. Subjects eat a healthy American diet for both~          of the required 4-week diet periods; about 1-1/2 cups of cooked legumes, such as pinto,~          baked, and navy beans are added to one of the two required diets. For the third~          (optional) diet period, subjects are given the same 1-1/2 cups of legumes, but are~          allowed to lose weight. Participants are given packages with all of the food they are to~          consume during the three diet periods. They may add up to five caffeine-containing~          beverages per day and up to two alcoholic drinks per week. They must eat all of the food~          they are given and only the food they are given. Subjects are expected to maintain a~          constant body weight during the two 4-week required diets, and their caloric intake may~          be increased or decreased as needed to maintain their screening weight.~        -  Weight measurements: Subjects are weighed regularly at the clinic.~        -  Blood samples: Subjects have blood samples drawn at the mid-point of each of the two~          required 4-week diets and at the beginning and end of each of the three 4-week diets.~        -  Urine and stool samples: Urine and stool samples are collected at the beginning and end~          of the two required 4-week diets.~   "
245553|NCT00339456|"~     Although highly active antiretroviral therapy (HAART) has been successful in suppressing~     plasma HIV RNA levels and providing significant clinical benefit in infected patients, it~     does not eradicate HIV infection. It is now clear that virus replication persists despite~     undetectable plasma viremia in individuals receiving HAART. In this regard, withdrawing~     HAART, even after prolonged periods of virus suppression, leads almost invariably to a rapid~     rebound of plasma viremia. It is also now clear that prolonged, continuous HAART carries a~     risk of significant toxicity and side effects. In addition, the monetary cost of HAART is~     prohibitive for many individuals and countries. In terms of cost, 95% of the HIV-infected~     individuals in the world are beyond the reach of therapy as a direct consequence of the cost~     of therapy. These observations may argue for a different approach to HAART with the goals of:~     1) durable suppression of virus replication, without an attempt at eradication, 2)~     minimization of toxicity and side effects and improvement in patient life-style, and 3) a~     reduction in cost. Preliminary data from a pilot study conducted at the National Institutes~     of Allergy and Infectious Diseases, USA, have demonstrated that short cycle structured~     intermittent therapy, 7 days HAART drug followed by 7 days off HAART has maintained~     suppression of plasma HIV RNA while preserving CD4+ T cell counts for up to 80 weeks. In~     addition, there was no evidence for increased HIV in reservoir sites; nor was there evidence~     for the development of resistance to antiretroviral drugs. Finally, there was a decrease in~     parameters of toxicity. This approach may have particular applicability for the treatment of~     HIV in the Southern Hemisphere. Therefore, we propose to study the virologic and immunologic~     effects of short cycle intermittent versus continuous HAART in HIV-infected individuals from~     the JCRC (Kampala, Uganda) in a randomized, controlled, intent-to-treat trial. We shall~     evaluate both the 7 days on-HAART/7 days off-HAART as well as a 2 days off-HAART/5 days~     on-HAART approach. In December, 2004, the 7/7 arm was discontinued.~   "
245559|NCT00339378|"~     Previous studies have estabished pesticide exposure as a possible risk factor for childhood~     cancer. The Agricultural Health Study (AHS), a prospective cohort study of pesticide exposure~     among 51,000 pesticide applicators in North Carolina and Iowa, provides an opportunity to~     study childhood cancer incidence and mortality among the children of pesticide applicators.~     Name and dates of birth for 21,985 children were previously provided by adult participants in~     the AHS. The current study seeks to identify cases of cancer among these children through~     record linkage to state cancer and death registries. Cancer incidence and mortality within~     the cohort will be compared with national data through standardized incidence and mortality~     ratios. A limited case-cohort comparison of pesticide exposures will also be performed.~     Approximately 44 cases of childhood cancer are expected to be identified. No follow-up or~     contact with cases is anticipated. It is anticipated that the study results will provide~     insight into the relationship of pesticide and other farm exposures to the pathogenesis of~     childhood cancer.~   "
245554|NCT00339443|"~     We propose to conduct a pilot study among 30 volunteers from the Division of Cancer~     Epidemiology and Genetics (DCEG) in order to: (1) select the urine pH strip that most closely~     correlates with urine pH measured by pH meter for the New England Bladder Cancer Study, (2)~     calibrate the urine pH strip that was used for the Spanish Bladder Cancer Study against pH~     measured by a pH meter, and (3) compare the DNA yields from buccal cells obtained from two~     different methods: mouthwash vs toothbrush-rinse method. Information collected from this~     pilot study will be used to select and optimize the sample collection protocols in the New~     England Bladder Cancer Study. At the time of enrollment, study participants will be asked to~     provide information on age, gender, height, weight, consumption of antacids and calcium~     supplements, and whether they ate, drank or brushed their teeth in the last hour previous to~     the buccal cells ample collection. In addition, they will have to measure their urine pH with~     four different pH strips twice a day (early morning and before dinner) for a week and record~     the measurements in a diary. During the same week, they will be asked to collect two spot~     urine samples each day from Monday to Thursday (early morning and before dinner), and one~     more on Friday morning, and bring them into work in a cooler. Also, they will be asked to~     collect a continuous 24-hour urine sample during one of the three first days of the week.~     Urine samples will e picked up by lab personnel from BioReliance, and pH will be measured at~     their laboratory with the four pH strips again and with a pH meter. Buccal cells sample~     collection will be completed during the first and the last day of the urine sample collection~     period. The first day, study participants will be asked to provide a water rinse sample after~     brushing the inside of their cheeks with a toothbrush, and a week later they will be asked to~     provide a mouth wash sample consisting of two consecutive rinses with Scope mouthwash. All~     samples and questionnaire data will be unlinked from personal identifiers after the sample~     collection is completed. Participants will be compensated with $100 for the inconvenience of~     participating in this complex study and for their time.~   "
245555|NCT00339430|"~     Since the beginning of the HIV/AIDS epidemic, the number of women infected with HIV has~     rapidly increased and is continuing to climb. The Women's Interagency HIV Study is being~     conducted in several cities in the United States to learn more about how HIV affects women's~     lives and bodies. It will examine the role of HLA and killer immunoglobulin-like receptors~     (KIR) in HIV and related infections in HIV-positive and HIV-negative women. The study will~     determine the relationship between KIR and HLA genes and the following: the risk of HIV~     infection; HIV levels in the blood; incidence of AIDS; response to highly active~     antiretroviral therapy (HAART); and response to immunotherapy.~      Approximately 3,700 women will participate. Participants will visit the clinic every 6 months~     for 4 years. An HIV test will be given each time to HIV-negative women. A questionnaire will~     also be administered. A physical examination and gynecological examination will be given.~     Blood, vaginal swabs, and urine will be collected for testing. A biological impedance test~     will determine any changes in weight, waist-to-hip ratios, and breast and total body fat. Low~     CD4 counts and hospitalizations for HIV are to be self-reported to study staff.~   "
245556|NCT00339417|"~     This study, conducted in Mali, West Africa, will determine whether a new treatment regimen~     for lymphatic filariasis can eliminate the disease more quickly than the standard regimen.~     Lymphatic filariasis is caused by infection with very small filarial worms called Wuchereria~     bancrofti that are spread by mosquitoes. The disease can cause swelling of the arms, legs,~     breast and genitalia and can progress to permanent swelling of the legs or arms called~     elephantiasis. Currently, patients in Mali are treated with a single dose of 400 mg of~     albendazole plus two doses of 200 mcg/kg of ivermectin each year. This study will use a~     regimen of 800 mg of albendazole twice a year plus 200 mcg/kg of ivermectin twice a year for~     2 years. The study will see if the new regimen is more effective in lowering the numbers of~     Wuchereria bancrofti in the blood and will examine the effects of the two treatments on the~     adult worms living in the lymph system.~      Healthy people between 14 and 65 years of age who live in the Mali village of N'Tessoni and~     are infected with Wuchereria bancrofti may be eligible for this study. Candidates are~     screened with a medical history, a brief physical examination and blood tests to check for~     infection with Wuchereria bancrofti and to measure white blood cell counts.~      Participants undergo the following procedures:~      -First visit~      Ultrasound examination to look for filarial worms in the body.~      Random assignment to receive either standard treatment or the experimental regimen~      Urine pregnancy test for women of child-bearing age.~      Receive first treatment dose.~      -6-month visit~      Short history, physical examination and blood test.~      Second treatment dose for subjects in experimental treatment group.~      Urine pregnancy test for women of childbearing age.~      -1-year visit~      Short history, physical examination and blood test.~      Second or third treatment dose, depending on treatment group.~      Repeat ultrasound in subjects whose first ultrasound detected adult worms.~      Urine pregnancy test for women of childbearing age.~      -18-month visit~      Short history, physical examination and blood test.~      Fourth treatment dose for subjects in experimental treatment group.~      Urine pregnancy test for women of childbearing age.~      -24-month visit~      Short history, physical examination and blood test.~      Repeat ultrasound in subjects whose first ultrasound detected adult worms.~      Urine pregnancy test for women of childbearing age.~   "
245557|NCT00339404|"~     In collaboration with members of The International Melanoma Consortium, we propose to study~     melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2 or~     p16) gene, or the cyclin-dependant kinase 4 (CDK4). CDKN2 and CDK4 are both genes that encode~     presumed tumor suppressor genes, mutant forms of which are known to cause increased~     susceptibility to melanoma. The purpose of the present study then is to confirm the existence~     of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular)~     and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies.~     It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by~     genetic and environmental factors (e.g. sun exposure). Characterization of such genes could~     provide important insights into the inheritance, pathogenesis, and treatment of this~     increasingly important disease.~   "
245558|NCT00339391|"~     This project is a collaboration between the Centre Regional de Medecine Traditionnelle (CRMT)~     of the Malian National Institute of Public Health Research (INRSP) and the Section on~     Socioenvironmental Studies (SSES). These units developed a three-pronged protocol reflecting~     their joint and individual concerns:~        1. Effects of occupational complexity on psychological functioning. The project tests a~          theory derived from previous SSES research demonstrating that in industrialized~          societies doing relatively self-directed, substantively complex work increases~          self-directed orientations to self, society and family and promotes effective~          intellectual functioning. It uses sociological survey methodology to determine the~          generalizability of this theory to an essentially pre-literate, preindustrial society.~        2. Effects of work-related stress on mental health. Earlier SSES work demonstrated that~          stressful work conditions lead to distress in industrialized societies. This project~          extends the investigation of these effects to a non-industrialized setting. It also~          extends the investigation of work-related stress to include work-related migration,~          resting a hypothesis that relates equally to SSES and CRMT concerns: that individuals~          from rural ethnic groups with a cultural tradition of work-related migration will show~          fewer mental health problems when migrating for nontraditional work than those from~          cultures without such a tradition. Mental health problems are assessed through: a)~          adaptations of standard survey-based psychological measures of components of distress,~          b) general and culture-specific survey-based psychiatric screening questions, and c) a~          psychiatric interview conducted by a CRMT psychiatrist trained in internationally~          accepted diagnostic procedures and knowledgeable about local cultures.~        3. The effects of migration and cultural and socioeconomic factors on AIDS-related~          knowledge, attitudes and behaviors. The survey addresses concern regarding the degree of~          knowledge about the nature of AIDS among rural Malians who are relatively isolated from~          urban oriented sources of information about culturally non-traditional issues. It also~          examines how socio-cultural background and migration for work affect AIDS related~          attitudes and self-reported behaviors in an African society where estimates of HIV~          prevalence are still relatively low (less than 2%), compared to those of other~          sub-Saharan African countries.~      Although these prongs are distinguishable, each requires a longitudinal design, a~     representative sample, extensive information about responders' social and cultural~     backgrounds, occupational histories, work conditions, and personal orientations and beliefs.~     Because of their overlapping theoretical approaches and methodological requirements,~     combining them in one project increases the richness and efficiency of the data collected for~     each.~   "
245560|NCT00339365|"~     This study will evaluate the effectiveness of the Promoting First Relationships (PFR) program~     versus an Early Education Support (EES) program in promoting infant well-being, preventing~     emotional and behavioral problems, countering developmental delay, and reducing placement~     instability in young foster care children.~   "
245561|NCT00339352|"~     To advance understanding of environmental, behavioral and genetic causes of brain tumors in~     adults, DCEG investigators initiated a multicenter case-control study of malignant and benign~     tumors in adults in 1994. This four-year study was conducted at participating hospitals in~     Boston, Phoenix, and Pittsburgh. Eligible cases were individuals greater than or equal to 18~     years newly diagnosed with an intracranial glioma, meningioma or acoustic neuroma and treated~     at one of the participating hospitals. The controls were patients admitted to neurological,~     neurosurgical or general surgical services at the same three hospitals for any of a variety~     of non-neoplastic conditions. By the end of the study, 811 brain tumor cases had been~     accrued.~      Information about a broad range of possible environmental, lifestyle, and genetic risk~     factors was obtained from both cases and controls through a computer-assisted personal~     interview (CAPI). The family history component obtained history and age at diagnosis of~     cancer or benign brain tumors and selected other diseases, for all living and deceased first~     degree relatives. A supplemental self-administered questionnaire covered diet, vitamin~     supplements, alcohol consumption, and household use of electrical appliances. Blood samples~     were obtained as a source of DNA. Currently, data analysis is in the early stages.~      To increase our ability to examine both genetic and environmental components of brain tumor~     risk, we decided to add a family studies component to the case-control study, focusing on~     families of glioma cases. Initial contact with each family is made through the cases or, if a~     case is deceased, through the next of kin. Cases or next of kin are asked to complete a~     Family Health Questionnaire that updates the family medical history and provides contacting~     information for all adult first degree relatives and more distant relatives with cancer.~     Then, we contact all first degree relatives greater than or equal to age 18 years, and the~     next of kin of deceased eligible relatives and invite them to complete a modified risk factor~     interview conducted over the telephone. This interview obtains information about each~     relative s personal and family history of cancer and other diseases, and history of risk~     factor exposures, including all the major categories covered in the case-control study. Study~     participants who complete the interview are then asked to provide buccal cells as a source of~     DNA for future genotyping.~      The glioma cases and their relatives will serve as a unique resource for both epidemiologic~     and genetic analyses. Selected relatives can serve as controls for association thereby~     eliminating concerns and population stratification. The study design also permits assessment~     of specific genetic hypotheses that cannot be evaluated in a traditional case-control study.~     Data from all first degree relatives of the glioma cases will be used in association studies~     and segregation analysis. In addition, we can screen DNA from members of multiplex families~     (families with 2 or more relatives with a primary CNS tumor) for mutations in candidate genes~     known to be associated with glioma, and contribute data from selected multiplex families to~     collaborative linkage studies to search for new genes conferring susceptibility to brain and~     possibly related tumors.~   "
245680|NCT00337766|"~     Patients undergoing cardiac surgery could develop excessive perioperative bleeding requiring~     transfusions of blood products.~      Desmopressin (DDAVP), already used for patients with von Willebrand syndrome, could reduce~     bleeding and transfusion requirements in these patients when administered ev (0.3 mg/kg) in~     20-30 minutes postoperatively.~   "
245562|NCT00339339|"~     This study will determine whether placement of composite (white) dental restorations~     (fillings) increases concentrations of bisphenol A (BPA) and its metabolites in saliva and~     urine. These compounds have estrogenic-like properties that have raised concerns about their~     safety. Small amounts of the chemicals can leach out of dental sealants and be detected in~     saliva soon after the sealants are applied. Dental composites also contain some of these~     compounds.~      U.S. Commissioned Corps officers who need fillings as part of their regular dental treatment~     and who select composite (white) restorations instead of amalgam (metal) may be included in~     this protocol. Participants are recruited from among officers receiving dental care at the~     commissioned officers dental clinic in Rockville, Md.~      Participants complete a 15-minute interview to gather information about their recent diet and~     eating patterns. They also provide 3 to 4 urine and saliva samples, some collected before~     their dental restoration and some after treatment.~   "
245563|NCT00339326|"~     This study will try to identify risk factors for Kaposi s sarcoma, a rare skin cancer, and to~     understand the role of the KSHV virus in development of the disease.~      All native-born Italians 21 years of age or older residing in Sicily from July 1, 2002~     through June 30, 2005 who have Kaposi s sarcoma not related to HIV infection may be eligible~     for this study. Healthy control subjects will also be enrolled.~      All participants will be interviewed about their childhood, jobs, habits, medical conditions,~     and treatments. They also will provide a blood sample and a saliva sample, obtained by~     swishing a mouthwash for 45 seconds and spitting it into a container.~      Blood will be tested for two viruses KSHV and HIV that are related to Kapsosi s sarcoma. The~     KSHV virus is newly discovered and not well understood. In general, a positive KSHV test~     probably means an infection with the virus has occurred in the past, but not necessarily that~     disease has developed. HIV is the virus that causes AIDS. People with AIDS have a high risk~     of Kapsosi s sarcoma. Although HIV and AIDS are very rare among older adults in Sicily, the~     presence of HIV must be ruled out in order to understand how KSHV is related to Kapsosi s~     sarcoma.~      The blood may also be used to measure immunity (the body s defense against infection and~     cancer) and for genetic studies to help discover why Kapsosi s sarcoma occurs.~   "
245564|NCT00339313|"~     This protocol is for study of the effect of inhibition of parasympathetic outflow on insulin~     secretion and glucose metabolism. Insulin secretion will be measured during infusions of~     escalating doses of atropine. Other clinical parameters of parasympathetic inhibition by~     atropine will also be assessed.~   "
245565|NCT00339300|"~     The etiology of brain tumors is poorly understood. Due, in part, to public concern about a~     postulated relationship between the use of cellular telephones or other increasingly~     prevalent environmental exposures and the incidence of brain cancer in adults, the National~     Cancer Institute is collaborating with three U.S. hospitals in a comprehensive case-control~     study of malignant and benign brain tumors. Factors under consideration include use of~     cellular phones and other wireless communication devices, workplace exposures to chemical~     agents and electromagnetic fields, dietary factors, family history of tumors, genetic~     determinants of susceptibility, home appliance use, reproductive history and hormonal~     exposures, viruses, medical and dental exposure to ionizing radiation, and other aspects of~     medical history.~      Approximately 800 newly diagnosed brain tumor cases and 800 controls have been enrolled at~     hospitals in Boston, Phoenix and Pittsburgh. Cases include all adults (age greater than or~     equal to 18 years) newly diagnosed with a histologically confirmed intracranial glioma,~     intracranial meningioma or acoustic neuroma. Controls are patients admitted to the same~     hospitals as the cases, and treated for any of a variety of non-malignant conditions.~     Participating cases and controls were interviewed in the hospital by a research nurse and~     asked to complete a self-administered questionnaire and donate a sample of blood. Key~     features of the study include its large size, the emphasis on rapid ascertainment of incident~     cases and interview of study subjects rather than surrogate respondents, the use of detailed,~     job-specific questions developed by industrial hygienists to ascertain occupational~     exposures, and the storage of blood samples for future evaluation of inherited~     susceptibility, biomarkers of exposure and gene-environment interactions.~      Implementation of the study protocol proceeded without serious problems. There have been no~     harmful effects on study participants. There have been no complaints from participants or~     breaches of confidentiality. Continuation of this research involves analysis and reporting of~     results. As there will be many papers, this process is expected to extend over the next~     several years.~   "
245566|NCT00339287|"~     Human phagocytic cells such as polymorphonuclear leukocytes (PMNs) are readily mobilized to~     sites of infection and ingest microorganisms by a process known as phagocytosis. The combined~     effects of reactive oxygen species (ROS) and proteolytic peptides and enzymes released into~     forming bacterial phagosomes kill most ingested bacteria. However, many human bacterial~     pathogens have devised means to subvert normal phagocyte responses and the innate immune~     response and cause severe disease.~      The overall objective of this study is to elucidate specific features of pathogen-phagocyte~     interactions that underlie evasion of the innate immune response or contribute to the~     pathophysiology of disease or inflammatory disorders. Therefore, specific projects will:~        1. Identify and characterize specific mechanisms used by pathogenic microorganisms to evade~          or subvert normal phagocyte responses and therefore cause disease.~        2. Investigate phagocyte response mechanisms to specific pathogenic microorganisms.~        3. Identify specific bacterial structures and/or (gene) products that dictate differences~          in phagocyte responses among a range of pathogens so that generalized statements can be~          made about the pathophysiology of disease states.~      The studies will be performed using multiple techniques including state-of-the-art equipment~     for genomics and proteomics strategies to identify target bacterial genes/proteins of~     interest or those up-regulated in phagocytes. Phagocyte-pathogen interactions will be~     examined using fluorescence-based real-time assays and video microscopy, confocal and~     electron microscopy in combination with enzymatic assays for ROS production, routine~     biochemistry, immunology and cell biology.~      Implementing these studies will require isolation of phagocytic leukocytes from venous blood~     of healthy human volunteers. The study population will be all-inclusive except in certain~     instances where individuals possess genetic defects that impair phagocyte function (e.g.,~     myeloperoxidase-deficiency) or have altered phagocyte function due to outside influences such~     as recent bacterial or viral infection.~      The proposed studies will likely provide new information pertinent to understanding host~     cell-pathogen interactions and the pathophysiology of inflammatory conditions.~   "
245567|NCT00339274|"~     The large number of thyroid tumors that have occurred in areas exposed to high levels of~     fallout from the Chernobyl accident raise problems of public health importance, or regulatory~     importance, and of scientific importance. The over-riding priority must go to matters such as~     diagnosis, treatment of those affected and prevention, and International Agencies are giving~     financial and material help in these areas. However providing the needs of the patient are~     not compromised, it is very important to ensure that information that may be of value to the~     health of future generations is not lost. International agencies are again providing~     financial support for a variety of joint studies, some of which are based on studies of~     tissues from thyroid operations carried out as part of treatment, and not required for the~     initial diagnosis on which treatment is based. An international coordinated approach to this~     problem is not in place to help Belarus, the Russian Federation and Ukraine to establish~     their own comprehensive thyroid tissue and data banks and to ensure that tissue and nucleic~     acids are used to contribute to the understanding of the consequences of the Chernobyl~     accident. This project has the support of the Governments of Belarus, the Russian Federation~     and Ukraine and the National Cancer Institute of the USA, (NCI), the European Commission~     (EC), the Sasakawa Memorial Health Foundation of Japan (SMHF) and the World Health~     Organization (WHO) have agreed to cooperate in supporting this project.~   "
245568|NCT00339261|"~     This study is a continuing follow-up of patients with systemic lupus erythematosus (SLE) and~     control subjects enrolled in the Carolina Lupus Study and the University of North Carolina~     (UNC) Lupus Nephritis Study. SLE is a severe, chronic, disabling autoimmune disease that~     significantly affects health and quality of life. The disease most often affects young to~     middle-aged adults, and therefore can also affect work and disability. There is currently~     little information on work-related disability related to SLE. The goals of the current study~     are to:~        -  Determine health and work status of patients and controls in the Carolina Lupus Study~          and the UNC Lupus Nephritis Study;~        -  Develop and test methods for obtaining disease data from university- and community-based~          physicians in the study area;~        -  Examine the associations between sociodemographic, work-related factors, disease damage,~          and work disability among SLE patients and controls; and~        -  Assess the role of demographic and socioeconomic factors, psychosocial attributes, and~          potentially modifiable behavior or environmental factors (e.g., smoking, occupational~          exposures, medication compliance) in disease damage measures, and in the increased~          severity of disease among African-American patients.~      Patients and control subjects enrolled in the Carolina Lupus Study and the University of~     North Carolina Lupus Nephritis Study are eligible for this protocol.~      Subjects will participate in a 30-minute telephone interview that includes questions related~     to their current health status, medical care utilization, work and disability issues,~     psychosocial attributes (e.g., helplessness, social support), and changes in environmental~     exposures since the previous follow-up interview in 2001. With the patients' permission,~     disease damaged will be assessed using a standardized form to be completed by the patients'~     physician or using information obtained from the patient's medical record.~   "
245569|NCT00339248|"~     This study will analyze blood samples to identify substances that are associated with the~     development of breast cancer. It will determine if:~        -  Women who are diagnosed with a benign breast condition that is related to a considerably~          increased risk of breast cancer are more likely to have certain gene variants than women~          diagnosed with conditions related to very little increased breast cancer risk~        -  Women with benign breast conditions who subsequently develop breast cancer are more~          likely to have certain gene variants than women with similar benign conditions who do~          not develop breast cancer.~      This study will examine blood samples from premenopausal women who underwent breast biopsy~     (removal of a small piece of breast tissue for microscopic examination) at four hospitals in~     Grand Rapids, MI, from 1977 to 1987 and were found to have benign breast disease. The women,~     who agreed to participate in a study of markers for breast cancer, also provided a blood~     sample and were interviewed for information on their breast cancer risk factors, family~     history of breast cancer, use of medications, and history of medical conditions.~      This study will retrieve the biopsy reports for these women, determine which of them later~     developed breast cancer, and perform genotyping on their blood samples.~      The information from this study may help in future diagnosis and treatment of breast cancer.~   "
245570|NCT00339235|"~     The aim of this project is to establish a clinical database and a bank of biological~     materials which will be used to improve the pathophysiologic understanding of the mechanisms~     underlying various pregnancy diseases. The US-Mexico Reproductive Health Research Development~     Workshop, sponsored by the NIH, recommended that the setting up of tissue, blood, and~     placental banks from human and relevant animal models should be developed to aid in~     understanding how prenatal conditions relate to pathological consequences in adult life.~      A large observational study in the United States of America, the National Collaborative~     Perinatal Project (NCPP), was conducted over 30 years ago (1959-1966) and has yielded a large~     amount of useful information. However standards of obstetrical and neonatal care have changed~     significantly over the last 30 years. Thus the setting up of a contemporary clinical~     perinatal database and bank of biological materials is required. In order to obtain~     sufficient data for statistical analysis a large sample size is necessary.~      We propose to carry out this project at Sotero del Rio Hospital, Santiago Chile as this~     hospital has a delivery rate of approximately 14,000 women per year. Previous research~     collaborative efforts between the Sotero del Rio Hospital and the PRB have been carried out~     in compliance with NIH research regulations. Sotero del Rio Hospital has had previous~     successful negotiations of Single Project Assurances (SPA) with the NIH.~      Information will be collected from clinical history taking, physical examination, sonographic~     examination and standard laboratory procedures. The bank of biological fluids and tissues~     will include maternal blood, umbilical cord plasma, amniotic fluid, maternal urine and~     placental tissue. No procedures will be carried out on patients that are not part of standard~     of care at Sotero del Rio Hospital.~   "
245571|NCT00339222|"~     During the course of a case-control study of melanoma conducted at the Bufalini Hospital,~     Cesena, Italy in the years 1994-1996, 20 families with 2 or 3 melanoma cases were identified~     and studied. The area where the study was conducted showed the steepest increase in melanoma~     incidence in Mediterranean populations between the years 1987 and 1997.~      Clinical characteristics of melanoma in the families studied were similar to those typically~     described in fair-skinned populations, but no relevant mutations in the coding regions of~     known candidate genes from melanoma have been found. Lack of findings could be due to the~     modest number of families and the small number of affected CMM cases examined. We cannot~     exclude the possibility of alterations in introns, splicing sites or promoter regions. Also~     epigenetic factors could affect the expression of the gene products we studied.~     Alternatively, germline alterations of a gene(s) other than the candidate genes we analyzed~     may play an important role in melanoma predisposition in this population. A large number of~     families is needed to test these hypotheses.~      These additional families could provide an important contribution to the understanding o~     melanoma development. In fact, this population does not generally have the host~     characteristics that are usually associated with higher risk for melanoma (e.g., light skin~     color, red hair, blue eyes, multiple freckles, tendency to sunburn, etc.) but do have a~     relative high frequency of dysplastic nevi and melanoma.~      The main objective of this study is to recruit more families at the Bufalini Hospital,~     Cesena, Italy in order to reach a larger sample size. Recently, 16 potential melanoma-prone~     families have been identified through patient's or physicians' referrals by the~     Dermatologists at the Bufalini Hospital. The dermatologists have maintained close~     relationships with members of these families and are confident that these subjects would be~     willing to participate in a study if contacted. The first goal of our study is to contact~     this family group and verify their willingness to participate in the study. In addition, new~     families could be identified and recruited.~      We propose to conduct a pilot project. We estimate recruitment of approximately 25 families~     with 2 or more melanoma cases in first -degree relatives over a one-year period, including~     the 16 families already identified and approximately 10 new kindreds. At the end of the pilot~     phase we will determine the feasibility of continuing recruitment....~   "
245572|NCT00339209|"~     This study will create a database of clinical and biological research for use in future~     studies, with information obtained from lung transplant recipients. The database will consist~     of genetic material and clinical outcomes to be used in future genotyping studies, that is,~     studies regarding the genetic makeup of individuals. Lung transplantation has become an~     important option for patients with advanced lung disease. More than 10,000 patients have~     received them to date, and about 1,200 transplant operations are performed worldwide each~     year. Although short-term survival has continued to improve, the 5-year survival rate is less~     than 50 percent. Most post transplant deaths are directly or directly caused by chronic lung~     rejection, a condition of scarring that worsens lung function.~      Patients evaluated for lung transplants at Duke University Medical Center may be eligible for~     this study.~      For developing the database, a small amount of blood, about 3 tablespoons, will be collected~     from patients. Blood collection for the research will be done at the same time as blood is~     drawn for necessary tests. The blood cells and DNA (which contains genetic material) will be~     isolated for analysis. Patients' DNA samples collected will be identified by a code, and all~     other identifying information will be removed. Patients may be asked to donate additional~     blood samples after their lung transplant if researchers would like to reexamine their blood.~      This study will not have a direct benefit for participants. However, during the study, if it~     is found that any patients have an inherited risk for a disease likely to cause early death~     if the disease is not treated, then the researchers will attempt to notify those patients.~     Overall, it is hoped that information gained during this study will help medical~     professionals to learn more about immune activation and to see how the reactivity of lung~     transplant patients changes over time. If specific genetic risks could be identified, it~     might lead to individualized treatments that work on the immune system. Short-term and~     long-term survival of lung transplant recipients may thus be improved.~   "
245573|NCT00339196|"~     MULTICENTERS. Uncontrolled and open phase II study. Evaluation of the effectiveness of a~     treatment associating 5 Azacytidine,Valproic acid ,Retinoic Acid at subjects-reached of~     syndromes myelodysplasia and acute MYELOID leukaemia Hematological response at 6 months~     Uncontrolled prospective cohort.~   "
245608|NCT00338741|"~     The objective for establishing the Rebif® Pregnancy Registry is to collect prospective~     outcomes data on women in the United States and Canada who have been exposed to Rebif® during~     their pregnancies. The primary end point will be the rate of spontaneous abortions in exposed~     pregnancies. This rate will be compared with the rate of spontaneous abortions in patients~     with Multiple Sclerosis (MS) whose pregnancies were not exposed to any interferon-beta in a~     manner consistent with the FDA August 2002 Guidance for Industry: Establishing Pregnancy~     Exposure Registries~   "
245609|NCT00338728|"~     The goal of this clinical research study is to learn if the combination of Femara (letrozole)~     and Gleevec (imatinib mesylate) can shrink or slow the growth of the tumor in patients who~     have hormonal sensitive advanced breast cancer.~      Primary Objectives:~        -  To determine the efficacy of Letrozole plus Imatinib Mesylate in patients with ER and or~          PgR positive metastatic breast cancer. Efficacy will be measured by the rate of clinical~          tumor response.~        -  To determine the safety and tolerability of Letrozole plus Imatinib Mesylate in patients~          with metastatic breast cancer.~        -  To determine the time to disease progression and overall survival in patients with~          metastatic breast cancer who are treated with Letrozole plus Imatinib Mesylate.~   "
245610|NCT00338715|"~     Atrial fibrillation (AF) is an irregular heart rhythm that occurs in 30% to 40% of patients~     following heart surgery. This irregular heart rhythm, although often self-limiting, can be~     cause for concern. AF is associated with a two-fold increase in patient complications and~     mortality after heart surgery. During AF, the heart muscle does not contract properly causing~     the blood flow through the heart to slow down potentially forming clots. A clot may then~     enter the blood stream and be carried to the brain, possibly causing a stroke. Patients in~     persistent AF require blood thinners to prevent strokes, and this carries its own bleeding~     risks especially in elderly patients.~      Patients in AF after heart surgery spend twice as many days in the intensive care unit and 3~     to 4 more days in the hospital, hence the impact on hospital resources is quite significant.~     Various medications are used to prevent AF after heart surgery but they are unable to~     completely prevent this complication and the medications have associated side effects. In an~     effort to optimize the care of heart surgery patients, strategies set on eliminating the~     onset of AF after surgery, as opposed to trying to control AF with less than effective~     medications, is a necessity.~      We are proposing a study to determine if isolating the misfiring areas that cause AF at the~     time of bypass surgery in high-risk patients will decrease the occurrence of AF following~     heart surgery. Consenting patients will be randomized to one of two groups. Group 1 will~     undergo bypass surgery plus the additional procedure of pulmonary vein isolation and Group 2~     will undergo bypass surgery only, without the additional procedure. Four staff cardiac~     surgeons at the London Health Sciences Centre will perform all surgeries. Patients will be~     seen postoperatively every six months and will be followed for a two-year period. The~     occurrence of AF will be recorded as well as other complications and lengths of hospital~     stay. We predict that the group with the additional pulmonary vein isolation procedure to~     prevent AF will have a much lower occurrence of this complication. If this is found to be~     beneficial, this will significantly decrease the complications and mortality associated with~     heart surgery. This will have a profound effect in the delivery of care to patients with~     coronary artery disease and other forms of heart disease.~   "
245611|NCT00338702|"~     Foot ulcers represent a significant common complication in patients with diabetes. Wound~     healing is a challenge. Some wounds do not respond to the best practices in wound care.~     Considerable effort has been directed at therapies to improve the rate of healing.~      There are a variety of growth factors which have been used to stimulate wound healing. Human~     platelets are an autologous source of growth factors which probably can stimulate healing.~     Autologous platelet gel (APG) is prepared by centrifugation of autologous human whole blood.~     APG is rich in platelet growth factors. This study will investigate the potential improvement~     in wound healing with this material in diabetic foot ulcers.~      This study will compare the use of autologous platelet gel ( study group) and standard care (~     control group) in the treatment of diabetic plantar forefoot ulcers. This study will also~     compare the cost and quality of life in the two groups.~      Objectives of the study:~        -  To determine if topical APG (autologous platelet gel) is beneficial in the treatment of~          diabetic foot ulcers.~        -  To determine if it will result in a faster rate of wound healing.~        -  To determine if it will improve the quality of life in patients with diabetic foot~          ulcers.~   "
245612|NCT00338689|"~     Primary hypothesis to be tested:~      Early protein intake predicts infant growth and later risk of childhood obesity.~        -  Childhood obesity is a major public health problem and is an identified priority concern~          for the health care. Infants fed formula are more likely to become obese than breastfed~          infants. The higher protein content of infant formulae, compared with breast milk, could~          be a causal factor.~        -  The study will in a multicentre intervention trial on newborn infants investigate~          whether feeding infant formulae, which differ in their level of milk proteins, can~          influence the risk of later childhood obesity. The trial will take place in five~          countries with different habitual total protein intakes to increase the range of protein~          intakes~        -  The investigators will study body composition, hormonal status, protein metabolism and~          anthropometric markers of childhood obesity. The whole cohort will be followed up until~          age 11 years, to assess the long term impact on the prevalence of obesity.~        -  The investigators will explore the impact of consumer (parental) attitudes to, and~          perceptions of, different practices of infant feeding in relation to infant behaviour~          (satisfaction, crying, sleep duration). This consumer science information will help~          improve the understanding of consumer (infants and parents) acceptance of and preference~          for foods that contribute to healthy diets.~        -  If a relationship between early dietary protein intake and later childhood obesity risk~          is confirmed, it offers possibilities for the prevention of obesity, for improving~          advice given to parents and for developing nutritionally improved dietary products for~          infants.~   "
245613|NCT00338676|"~     Aortic stenosis (AS) is AS is caused by calcium deposits in the aortic valve. Calcification~     is progressive and eventually leads to reduced leaflet motion with obstruction of the left~     ventricular outflow. The only treatment is surgery. There are evidences that AS is a~     regulated process with similarities to atherosclerosis but determinants of AS progression are~     unknown. The study aims at evaluating these determinants and more specifically the role of~     lipids, inflammation and platelet aggregation.~   "
245614|NCT00338663|"~     The purpose of the study is to determine if there is difference in immediate postoperative~     pain levels (48 hours) between patients who wear a knee immobilizer splint compared to~     patients who do not wear a knee immobilizer splint after an anterior cruciate ligament~     reconstruction surgery.~   "
245615|NCT00338650|"~     The primary objective of this study is to make adalimumab available to patients suffering~     from moderately to severely active Crohn's Disease who have failed to respond to, lost~     response to, or are intolerant to infliximab, and to evaluate safety~   "
245681|NCT00337753|"~     The purpose of the study is to evaluate a new form of counseling for pathological gambling~     and to see if the counseling is more effective than attending Gamblers Anonymous.~   "
245618|NCT00338611|"~     The purposes of the CITT are:~        -  To determine whether Home-based Pencil Push-up therapy, Home-based Pencil Push-ups with~          Computer Vision Therapy/Orthoptics or Office-based VT/Orthoptics more effective than~          placebo treatment, and whether there are differences between the three treatments in~          improving subject symptoms and signs.~        -  To evaluate whether improvements in outcome measures are still present after one year of~          observation.~   "
245619|NCT00338598|"~     This placebo-controlled study is designed to evaluate the efficacy of glycine, an agonist of~     the glycine-B co-agonist site of the NMDA receptor, on alcohol consumption and craving as~     well as negative symptoms in schizophrenia.~      Glycine will decrease the rewarding action of ethanol and reduce ethanol consumption. Also,~     glycine will improve negative symptoms and cognitive deficits in schizophrenia.~   "
245620|NCT00338585|"~     The purpose of this study is to directly compare the safety and efficacy of intra-thrombus~     alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured~     by a 30 day open vascular free surgery rate.~   "
245621|NCT00338572|"~     In addition to high blood pressure, hypertension is characterized by inflammation, which is~     the body's response to injury or infection. Inflammation has been found to cause plaque~     formation on artery walls. This study will compare the effect of an exercise program versus a~     combined exercise and diet program on reducing inflammation in hypertensive individuals.~   "
245622|NCT00338559|"~     The effect of airway management on vomiting after strabismus surgery is unknown. The purpose~     of this study is to find out whether the use of different airway devices, such as LMA, which~     is a special mask placed in the throat or Endotracheal tube (ET tube), which is a soft tube~     placed in the wind pipe, affects the incidence of vomiting after surgery. Two hundred six~     children between the ages of 2 and 12 years are expected to take part in this study.~   "
245623|NCT00338546|"~     The purpose of this study is to improve the scientific understanding of the cardiovascular~     actions of cocaine, in particular the ability of cocaine to increase blood pressure.~   "
245624|NCT00338533|"~     Glaucoma surgery is performed on children less than 3 years old for infantile glaucoma which~     untreated can cause blindness. Glaucoma is an uncontrolled high eye pressure in these~     children often due to incomplete development of the part of the eye which normally allows~     fluid to drain out of the eye. Two procedures are possible and equal in their success of~     lowering the eye pressure. However, one (the goniotomy procedure) is preferred since it takes~     10 minutes rather than 1 hour (for the trabeculotomy procedure) to perform under general~     anesthesia. This is important in young children to reduce anesthesia exposure especially if~     both eyes need surgery. If the glaucoma has caused the cornea or front of the eye to become~     too cloudy, then the view is too poor to place a lens on the cornea and use a needle to~     perform the shorter procedure. However, a small endoscope which has been FDA approved for use~     in the eye will allow direct viewing of the area which needs treatment. A needle attached to~     this endoscope allows the shorter goniotomy to be performed rather than proceeding to the~     longer trabeculotomy procedure. The outcome measure of this study is anesthesia time and~     reduction in intraocular pressure .~   "
245625|NCT00338520|"~     The purpose of this study is to see if children, who develop coma from malaria, are not~     making enough of a vitamin-like chemical, tetrahydrobiopterin (BH4), which is required for~     the brain to function normally. This information may help to identify new ways to treat~     malaria in the future. Study participants will include 512 children, ages 6 months to 6~     years. Participants will be placed into one of 4 groups: well children; children with mild~     malaria; children without malaria, but with a medical problem involving the brain that~     requires a lumbar puncture for diagnosis (a procedure in which a needle is placed into an~     area surrounding the spinal cord and a sample of cerebral spinal fluid is removed); and~     children with a severe form of malaria affecting the brain called cerebral malaria. Study~     procedures will include blood samples, urine samples and lumbar puncture, only if necessary~     for diagnosis as part of standard practice procedures. Participants will be involved in study~     related procedures for up to 3 weeks.~   "
245626|NCT00338507|"~     This clinical study is designed to explore dose ranging and identify methods to demonstrate~     the efficacy of Erdosteine in patients with stable Chronic Bronchitis associated with Chronic~     Obstructive Pulmonary Disease.~   "
245627|NCT00338494|"~     Clofarabine is a new chemotherapy drug which was FDA approved for the treatment of acute~     lymphocytic leukemia in children. This study is being done to see if Clofarabine works in~     adult patients with B-cell types of lymphoma.~      This research is being done to develop new treatments for patients with lymphoma whose cancer~     has returned or resisted treatment with previous chemotherapy.~   "
245628|NCT00338481|"~     The purpose of this study is to test whether red morphine drops applied in the mouth are~     superior to an equivalent amount of morphine applied as subcutaneous injection for the relief~     of breathlessness in terminal patients suffering from primary lung cancer or lung metastases.~   "
245629|NCT00338468|"~     The purpose of this study is to assess disability in anemic patients over the age of 65 who~     have kidney disease and are receiving weekly PROCRITÂ® (Epoetin Alfa, a glycoprotein that~     stimulates red blood cell production).~   "
245630|NCT00338455|"~     The purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country~     equivalent) cardiac transplant candidates are to assess the safety and efficacy of Natrecor~     (nesiritide). The study will evaluate the drug's ability to prevent clinical worsening when~     administered as a 28-day continuous intravenous infusion in patients receiving standard care~     and continuous intravenous infusion of dobutamine or milrinone.~   "
245631|NCT00338442|"~     This study is to assess VariZIG™ for the treatment of patients at risk for developing serious~     complications from chicken pox.~   "
245632|NCT00338429|"~     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the~     effectiveness of the Strongest Families distance intervention compared to usual or standard~     care that is typically provided to children with mild to moderate sleep onset latency and/or~     bedtime resistance difficulties. This is a single-centre trial based at the IWK Health~     Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime~     resistance).~   "
245816|NCT00335907|"~     This research is being done to see if a protocol (a set of orders that determine how much and~     how quickly a drug/fluid is given) for fluid and drugs used to increase blood pressure~     (vasopressors) will work better then general clinical practices to improve outcomes in~     patients with septic shock.~   "
245634|NCT00338403|"~     We hypothesize that continuous positive pressure applied to the airway will decrease the~     ability of the nose to warm and humidify inspired air compared to zero or negative pressure.~      We will use continuous positive airway pressure (CPAP), a device commonly used to treat~     patients with sleep apnea, to vary the pressure in the airway and determine if increased~     pressure decreases the ability to warm and humidify inspired air. If our hypothesis is~     correct, it may explain the reason why CPAP is poorly tolerated in patients with sleep apnea;~     i.e., less ability to warm and humidify air leading to more nasal mucosal irritation.~   "
245635|NCT00338390|"~     The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a~     day improves the immunological response obtained with tenofovir + ddI or whether it is better~     to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint~     formulation) in a single daily dose to achieve these objectives.~   "
245636|NCT00338377|"~     Objectives:~      The primary objective will be to determine whether patients receiving the combination of~     dendritic cells and high dose IL-2 have sustained persistence of infused T cells compared to~     patients treated with T cells and high dose IL-2 alone.~      Secondary endpoints will include evaluations for tumor response and studies to determine~     whether dendritic cells enhance the infused T cells in anti-tumor activity and their ability~     to migrate to the tumor site. In addition, we will evaluate the characteristics of the~     infused T cells that correspond with effectiveness in vivo.~   "
245637|NCT00338364|"~     This study is designed to assess the effectiveness of the video-based intervention over and~     above current standard practice for pain control in the pediatric emergency department (ED).~     This is a single-center trial based at the IWK Health Centre. The primary outcome will be~     based on the CAMPIS coding of the video-taped pain response of the research participants.~   "
245638|NCT00338351|"~     Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants~     between 6-12 weeks of age at the time of the first vaccination against Streptococcus~     pneumoniae.~   "
245639|NCT00338338|"~     The sustained reduction in elevated blood pressure and lower incidence of adverse events of~     Lacidipine may provide additional benefits for hypertension patients than other CCBs (calcium~     channel blockers). This study is to compare the efficacy and safety of Lacidipine with~     Amlodipine, the most widely used CCB in Taiwan, in hypertensive patients.~   "
245640|NCT00338325|"~     This study is designed to implement the reading of age appropriate books by a trained reader~     into the waiting area of a pediatric day surgery unit to determine if it is effective at~     reducing the anxiety and pain levels of parents and children by providing a safe and calming~     activity for the child. This is a single-centre trial based at the IWK Health Centre. The~     primary outcome will be based on the anxiety and pain scores of the research participants.~   "
245641|NCT00338312|"~     This study is designed to evaluate efficacy and safety of a testosterone patch as treatment~     for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin~     therapy.~   "
245642|NCT00338299|"~     The purpose of this study was to test the effectiveness and safety of PROCRIT (Epoetin alfa)~     at a higher starting dose (60,000 Units) once per week, followed by a less frequent dose~     (60,000 Units every two weeks) in patients with cancer and chemotherapy induced anemia.~   "
245643|NCT00338286|"~     The purpose of this study is to assess the impact on tumor progression as evaluated by~     progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared~     with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating~     anemia according to label guidance in patients with metastatic breast cancer receiving~     standard chemotherapy.~   "
245644|NCT00338273|"~     The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients~     with bipolar depression.~   "
245645|NCT00338260|"~     The LIFE study was conducted from 1995-2001. This study was conducted in 9193 patients with~     high blood pressure and thickening of the main pumping chamber of the heart. The results~     showed that after an average treatment time of 4.8 years, treatment that was based on~     losartan was better than treatment based on atenolol for reducing the risk of having a~     stroke. The main study results were published in Dahlof et al. Lancet 2002;359:995-1003.~   "
245646|NCT00338247|"~     This study will provide pre-approval drug access to lapatinib, in combination with~     capecitabine, to patients whose breast cancer had progressed on other therapies~   "
245647|NCT00338234|"~     Anemia in intensive care and post-operative patients is due to both blood loss (leading to~     iron loss) and inflammation.~   "
245648|NCT00338221|"~     This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children~     with persistent diarrhea or malnutrition. The primary objective of the study is to determine~     the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the~     damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in~     children at HIAS in Fortaleza, Ce, Brazil, with persistent diarrhea (history > 2 weeks~     duration) or malnutrition.~   "
245649|NCT00338208|"~     We wish to evaluate a potential training program for patients with glaucoma, to become more~     efficient users of prescribed low vision devices for distance and near vision tasks. We~     hypothesize that the devices will improve efficiency. Prescribed devices will include a stand~     magnifier, a handheld magnifier, spectacle magnifiers for near vision, and a handheld~     monocular (telescope) and a bioptic telescope (spectacle-mounted telescope) for distance~     vision. The success of being able to use optical devices is dependent upon training. Optical~     devices are currently accepted and used for patients with visual conditions that decrease~     their central vision. The bioptic telescope is a pair of glasses with a small telescope~     mounted within the carrier lens. The glasses look and feel like a normal pair of glasses, but~     have a black device (telescope) protruding from the top of one lens for better identifying~     distance objects. The spectacle magnifier is mounted in a pair of glasses also for near~     vision~   "
245682|NCT00337740|"~     Whether beta-blockers or banding is the best therapy for primary prophylaxis of variceal~     bleeding is subject to debate. A randomized comparison between the two treatments was~     performed in candidates for liver transplantation. Patients with Child B and C cirrhosis with~     high risk varices and no previous variceal bleeding are randomized to propranolol or variceal~     bleeding. Primary end point is variceal bleeding~   "
246795|NCT00322712|"~     Chart Review of patients with pancreatic cancer treated with combination of irinotecan,~     oxaliplatin and cetuximab.~   "
245650|NCT00338195|"~     Recent research has established that some individuals report that they are unable to cease~     caffeine use, despite feeling that caffeine is posing a health risk or causing significant~     impairment in their daily activities. Despite the high rates of unsuccessful efforts to cease~     or control caffeine use in the population, there has been little research on the parameters~     of successful caffeine reduction and no research on caffeine cessation.~      The goals of the study are as follows:~        1. evaluate the applicability of DSM-IV dependence criteria for self-reported problematic~          caffeine use.~        2. evaluate characteristics (e.g, co-morbid psychopathology) of individuals who report that~          they have had difficulty quitting caffeine use on their own and who are seeking~          treatment for caffeine use.~        3. test the efficacy of a caffeine reduction treatment administered to individuals who~          would like to quit/reduce caffeine use, but have found it difficult to do so in the~          past.~   "
245651|NCT00338182|"~     The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152~     when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2~     consecutive days every 14 days in patients with advanced solid malignancies.~   "
245652|NCT00338156|"~     This study will assess the relationship between collagen turnover, neurohormonal activation,~     scarring and left ventricle remodelling in patients 3 years following a myocardial~     infarction.~   "
245653|NCT00338143|"~     This is a Phase IIIb, open label, uncontrolled, multicenter study designed to evaluate the~     safety and tolerability of 12 weeks of subcutaneously administered efalizumab in subjects~     with moderate to severe plaque psoriasis who are candidates for systemic therapy and may also~     be receiving topical therapies, PUVA, or UVB phototherapy during the efalizumab treatment~     period.~   "
245654|NCT00338130|"~     The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with~     temozolomide in patients with advanced melanoma~   "
245655|NCT00338117|"~     The purpose of this study was to determine the safety and effectiveness of a relatively high~     dose of galantamine, 32 mg /day in a three-times daily dosage, compared with placebo in~     treating patients with Alzheimer's disease.~   "
245656|NCT00338104|"~     The primary objective of this study is to determine the optimal dose of glargine insulin when~     converting from intravenous short-acting continuous insulin infusions in surgical and~     intensive care unit patients using a prospective, controlled, parallel group, randomized~     study design.~      Note: Lantus insulin is the proprietary name for glargine insulin.~   "
245657|NCT00338091|"~     The primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of~     benazepril (an ACE inhibitor) or losartan (an ARB), as compared with their conventional~     doses, can safely improve the long-term renal outcome in nondiabetic patients with~     proteinuria and chronic renal insufficiency. The second aim was to compare the long-term~     renal protection between benazepril and losartan at similar clinical setting.~   "
245658|NCT00338078|"~     The purpose of this study is to determine whether oxygen therapy during sleep improves~     quality of life, exercise capacity and heart function among patients with chronic heart~     failure and central sleep apnea.~   "
245659|NCT00338065|"~     Our experiments are designed to test the overall hypothesis that position-dependent or~     water-dependent intra-ocular pressure (IOP) spikes occur in humans, and that these challenge~     ocular homeostasis.~   "
245660|NCT00338052|"~     This is an non-comparative study. There is no statistical hypothesis. The effects of~     extension of treatment on bleeding will be recorded and described.~   "
245661|NCT00338039|"~     The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic~     chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary~     endpoint is actuarial one-year survival.~      The secondary objectives are:~        -  To evaluate the local tumor response in patients treated with the above regimen.~        -  To characterize the safety of the above regimen.~   "
245662|NCT00338026|"~     The purpose of this study was to determine the maximum tolerated dose (MTD) and the~     recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for~     14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid~     tumors (high grade glioma, colorectal, lung, breast, ovarian, pancreatic and prostate). This~     study was also designed to determine the clinical pharmacokinetic profile, safety of multiple~     cycles of administration, and document the antitumor activity of ECO-4601.~   "
245663|NCT00338013|"~     You are being asked to participate in this study because we would like to know if sleeping~     may affect eye pressure.~   "
245664|NCT00338000|"~     The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of~     Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the~     treatment of anemia in predialysis.~   "
245665|NCT00337987|"~     The standard treatment for PTCL is CHOP (cyclophosphamide (C), adriamycin (H), vincristine~     (O), and prednisone (P)) chemotherapy. This study is attempting to determine whether adding~     other treatments to CHOP therapy will improve the chance of the disease going into remission~     or staying in remission. Because other drugs for T-cell lymphoma have not yet been given with~     CHOP, this study is looking at combining CHOP with ONTAK. ONTAK has been FDA approved for~     treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the~     surface of the tumor cells and killing the cell without causing damage to other types of~     cells in the body. Studies have shown that ONTAK has helped patients with PTCL who have~     failed chemotherapy.~   "
245666|NCT00337974|"~     The primary objective of this study is to evaluate the effects of a computer-based training~     program on the memory and cognitive abilities of mature individuals undergoing healthy aging.~   "
245683|NCT00337727|"~     The study will test aprepitant for the prevention of CINV in patients receiving their initial~     cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of~     chemotherapy may opt to participate in an optional second cycle during which the patient will~     receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant~     will be given in place of the oral formulation on study day one. Study drug administration on~     subsequent days will be given orally as in cycle 1.~   "
245758|NCT00336687|"~     About 40 % of the patients in reanimation are thrombopenics and the causes are not well known~     (reduction in platelet's production, increase in their destruction...). This protocol studies~     the epidemiology of thrombopenia for these patients and the impacts of cost and mortality in~     order to bring patients best medical cares.~   "
245667|NCT00337961|"~     The purpose of this study is to develop a way to perform safer surgery in the eye socket. The~     eye and its surrounding structures are very delicate and can easily be damaged from surgery.~     A laser may act as a gentle knife to cut the tissue. Currently, this is done with a small~     scissors and knife, but it could be done with gentle laser. By using an endoscope, the~     surgery could be much safer and faster. Vanderbilt has a Free Electron Laser, which could be~     used to make a small hole in the coverings around the optic nerve to treat certain diseases.~     Before it is used in seeing eyes, the laser must be tested on eyes which are to be removed~     during an enucleation to prove that it does not damage the optic nerve The standard~     enucleation (removal of your blind painful eye) will be performed. This procedure will be~     performed at the Free Electron Laser Center Operating Room, which is a fully equipped~     operating room currently being used for outpatient surgery. The post-operative recovery room~     setting is similar to the post-operative recovery room in the previously used area. This~     includes general anesthesia with a breathing tube in your throat, injecting an anesthetic~     liquid behind the eye for comfort after surgery, and removing the eyeball. Enucleations must~     be performed under general anesthesia or intravenous sedation with a retrobulbar injection~     (injection behind the eye). The anesthesiologist will determine which is safer to perform.~     The removed globe will be replaced with a spherical implant. Just prior to the removal of the~     eyeball, a small opening will be made in the coverings around your optic nerve (the cable~     exiting the eyeball) with the endoscopic laser or with a knife and scissors. The procedure~     should not take much longer than the standard eye removal. The procedure will be identical to~     the standard enucleation (eye removal) except for making the tiny hole in the coverings of~     the optic nerve, which should take about 15 to 30 minutes.~      The laser is very tissue specific. It only reacts with certain types of tissue and should not~     damage the surrounding tissue.~      There will be no additional costs to you associated with the study portion of the procedure.~   "
245668|NCT00337948|"~     The purpose of this study is to determine the effectiveness and safety of epoetin alfa at a~     starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL~     (Initiation Phase), followed by a dose of 60,000 U once every other week (Q2W) to maintain a~     Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients receiving chemotherapy.~   "
245669|NCT00337935|"~     The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to~     increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4~     weeks (Q4W) to maintain Hb levels, is safe and effective in patients with anemia from Chronic~     Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. In this study~     the frequency of PROCRIT (Epoetin alfa) dosing is under investigation.~   "
245670|NCT00337922|"~     This study was designed to explore the drug levels in the blood in Japanese HIV-infected~     patients taking EPZICOM tablet at least for 2 weeks prior to administration of the study~     drug. Pharmacokinetics after administration of EPZICOM tablet will be investigated in a total~     of 8 subjects.~   "
245671|NCT00337909|"~     The primary objective of this study is to evaluate the design and effectiveness of a~     computer-based training program on the memory and cognitive abilities of mature individuals~     undergoing healthy aging.~   "
245672|NCT00337896|"~     The purpose of this substudy study is to evaluate the types of cells involved in fighting~     infection to the A/H5N1 (avian flu virus) vaccine. A maximum of 30 healthy adults ages 18-64~     years, enrolled at Stanford University Hospital and participating in another clinical trial~     (DMID Protocol 04-062) will be enrolled into this substudy to collect additional samples of~     blood for testing before and approximately one week after each vaccination.~   "
245673|NCT00337883|"~     This is a Phase II, open-label, multicenter trial of single-agent treatment with Tarceva in~     patients with histologically confirmed GBM in first relapse. This study seeks to estimate the~     objective response rate and will investigate whether response rate is related to EGFR~     amplification status.~   "
245674|NCT00337870|"~     This study is designed to assess the effectiveness of the video-based intervention over and~     above current standard practice for pain control in the pediatric emergency department (ED).~     This is a single-center trial based at the IWK Health Centre. The primary outcome will be~     based on the Child-Adult Medical Procedures Interaction Scale (CAMPIS) coding of the~     video-taped pain response of the research participants (3-5 years old).~   "
245675|NCT00337831|"~     Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control~     therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution~     hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4~     additional weeks of control therapy the other intervention treatment will be performed.~     Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240~     min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).~   "
245676|NCT00337818|"~     The study will be extended for subjects who received all three doses of vaccine in Finland,~     Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18~     vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin~     and genitals in men and women. Several types of HPV infection are transmitted by sexual~     activity and, in women, can infect the cervix (part of the uterus or womb). This infection~     often goes away by itself, but if it does not go away (this is called persistent infection),~     it can lead in women over a long period of time to cancer of the cervix. If a woman is not~     infected by HPV, it is very unlikely that she will get cervical cancer. This study will~     evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified~     manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine~     safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.~   "
245677|NCT00337805|"~     This is a randomized double blind trial of the use of the use of colloids vs crystalloid~     solutions for resuscitation of patients after cardiac surgery. Patients are managed with an~     algorithm driven protocol that is based on the flow response to fluid challenges. The~     hypothesis is that the use of a colloid solution will result in less use of catecholamines at~     8:00 the morning following surgery. Secondary end-points include total use of catecholamines,~     time in the ICU, return to the ICU, and safety issues including bleeding and renal function.~   "
245678|NCT00337792|"~     The main objective of this study is to determine the equivalency of oral conscious sedation~     and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that~     oral conscious sedation will be equivalent to intravenous conscious sedation for pain~     control. Additional objectives include describing subject satisfaction with each method of~     pain control and characteristics of each method such as side effect profile, recovery room~     time, and postoperative pain.~   "
245679|NCT00337779|"~     Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the~     treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA),~     a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug~     that has anti inflammatory and neuroprotective properties. The study treatment duration is 12~     months.~   "
245684|NCT00337714|"~     Bloodstream infections are common in Intensive Care Units (ICUs). The need of a central~     venous line increases the risk of bacteremia and central venous catheter (CVC) related~     infections. The use of catheters coated and/or impregnated with different antimicrobial~     agents has been proposed to reduce the risk of such infections. However, results obtained so~     far did not reach enough clinical relevance to consider these medicated catheters as a valid~     alternative to the conventional ones.~      The aim of this comparative randomized study is to assess the ability of recently developed~     silver ion-releasing central venous catheters in preventing associated infections in~     comparison with the conventional ones.~      Experimental groups are defined as follows:~        -  Group A: patients treated with standard, triple lumen, non medicated catheters~        -  Group B: patients treated with triple lumen catheters impregnated with silver~          nanoparticles~   "
245685|NCT00337701|"~     This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc)~     using the B2000 needle-free injection device, in HIV-1 positive patients experienced to~     Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of~     Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device~     or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for~     the next 4 weeks. The anticipated time on study treatment is <3 months, and the target sample~     size is 100-500 individuals.~   "
245686|NCT00337688|"~     There are over 750,000 individuals in the U.S. with Cerebral Palsy (CP). Up to 46% of adults~     with CP report limited mobility in their communities. However, upper limb spasticity and~     problems with movement can make the independent use of a wheelchair difficult. Forty percent~     of individuals who desire mobility via electric wheelchairs are precluded from using them~     because of problems with upper limb function. No studies to date have produced devices that~     definitively improve mobility for these individuals. We will recruit 22 subjects with Spastic~     CP and 22 age and gender matched control subjects without apparent disability from~     advertisements, mailings, and outpatient clinics. Both a conventional joystick (MSJ) and a~     novel joystick that is customized for each subject will each be used six different computer~     screen tasks that simulate driving a wheelchair on a path. We will compare subjects and~     joysticks based on driving performance. Understanding problems with driving will help us to~     design joysticks and other assistive devices, not only for CP but for Traumatic Brain Injury,~     Spinal Cord Injury, Parkinson's Disease, stroke, or a variety of other disabilities.~   "
245687|NCT00337675|"~     This is a year-long study evaluating the efficacy of both daily and intermittent treatment of~     asthma in children who experience symptoms episodically (i.e., seasonally, usually in the~     context of upper respiratory tract infection).~   "
245688|NCT00337662|"~     The current study has been designed to address the significance of early onset of response~     prospectively in patients treated with an atypical antipsychotic.~   "
245689|NCT00337649|"~     This single arm study will determine the efficacy and safety of an epothilone D and Herceptin~     combination regimen in patients with HER-2 positive locally advanced or metastatic breast~     cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at~     a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly~     schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The~     anticipated time on study treatment is until disease progression, and the target sample size~     is <100 individuals.~   "
245690|NCT00337636|"~     Patients with infantile or late infantile NCL have either a reduced amount of, or are~     missing, the palmitoyl protein thioesterase 1 (PPT1) enzyme or the tripeptidyl peptidase 1~     (TPP-I) enzyme. Human central nervous system stem cells (HuCNS-SC) are an investigational~     product derived from human brain cells. HuCNS-SC have been shown to survive and migrate~     within the brains of mice. When grown in the laboratory, HuCNS-SC have been shown to produce~     the PPT1 and TPP-I enzymes. In mice missing the PPT1 enzyme, HuCNS-SC have been shown to~     increase the amount of this enzyme in the brain, to reduce the amount of abnormal storage~     material in the brain, and to prevent the death of some neurons (a type of cell) in the~     brain.~      Participation in this study will involve screening assessments, surgery to implant HuCNS-SC,~     medication to suppress the immune system, and a series of follow-up assessments. The length~     of time from the start of screening through to the last follow-up visit will be approximately~     13 months, with frequent visits to the study center during this time. After completion of~     this study, patients will be monitored for an additional 4 years under a separate long term~     follow-up protocol.~   "
245691|NCT00337623|"~     Corticosteroid therapy is usually regarded as a risk factor for the development of posterior~     subcapsular cataracts but prospective studies on this topic and accurate assessment of this~     potential adverse effect are lacking. We will evaluate changes of lens transparency after~     administration of systemic corticosteroid therapy for at least one year with Scheimpflug~     photography and quantification of lens autofluorescence.~   "
245692|NCT00337610|"~     A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2~     Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.~   "
245693|NCT00337597|"~     This prospective, comparative and double blind study is aimed to determine if normal saline~     or dextrose 5% in water will modify the stimulation during the insertion of the stimulating~     catheter used for continuous femoral and sciatic blocks in total knee replacement.~   "
245694|NCT00337584|"~     We are studying whether providing patients undergoing day surgery the opportunity to have~     their medical history reviewed by an hospital internist before surgery leads to better~     results after surgery. These doctors are internal medicine specialists who are experienced in~     assessing patients going to surgery, making sure they are fine-tuned before their~     operation. We believe this will ensure the safest and best surgical outcomes. The study~     involves the patient filling out a 3 page questionnaire for review by the internist prior to~     surgery. Additionally, patients will receive a follow-up phone call one week after surgery~     asking about the experience at the hospital and a questionnaire in the mail three months~     later to see if the patient had any medical problems after leaving the hospital.~   "
245695|NCT00337571|"~     This study will compare the effectiveness (how well the drug works) of aripiprazole with~     placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with~     a diagnosis of autistic disorder (AD).~   "
245699|NCT00337519|"~     Patients with advanced chronic lymphocytic leukemia (CLL) have a poor long-term prognosis.~     Allogeneic stem cell transplantation (SCT) in patients with CLL has only rarely been~     performed in the past because the clinical outcome after myeloablative conditioning was poor,~     mainly due to the high treatment-related mortality. However long-term disease-free survival~     after allogeneic SCT has been reported. Recently it has been demonstrated by our group and~     others that non-relapse mortality can be reduced significantly with the use of~     reduced-intensity conditioning regimens. Yet, graft versus host disease (GVHD) remains an~     important problem in this setting.~      Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been~     successfully applied for GVHD-prophylaxis in the setting of myeloablative and~     reduced-intensity conditioning regimens. The goal of the present study is to evaluate the~     role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for~     allogeneic SCT in patients with advanced CLL.~   "
245700|NCT00337506|"~     The objective of this study is to evaluate the efficacy and safety of Velcade plus~     dexamethasone used as induction chemotherapy prior to autologous transplantation.~   "
245701|NCT00337493|"~     This study will determine which, if any, allelic variants of mycophenolic acid (MPA)~     metabolizing enzymes, drug transporters and drug targets are associated with the observed~     variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage.~     Patients participating in study ML17225 will be eligible for this pharmacogenetic~     investigation, and will have one additional blood sample taken during the study. The~     anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size~     is 500+ individuals.~   "
245702|NCT00337480|"~     The purpose of this study is to determine whether the follow up of patients with acute~     coronary syndrome and modifiable cardiovascular risk factors is efficient based on~     outpatients visits in a House of Education, underlining the importance of nicotinic weaning,~     weight loss and physical activity practice.~   "
245703|NCT00337467|"~     The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced~     protease inhibitor therapy can maintain virologic suppression without a marked increase in~     virologic failure.~   "
245704|NCT00337454|"~     This study is composed of Phase I and Phase II part. Phase I part: The objective is to~     evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia~     (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The~     objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the~     results of Phase I part. Treatment period will be 6 months for subjects with chronic phase~     CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia~     Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)~   "
245705|NCT00337441|"~     The purpose of this study is to determine if chronic anemia can be corrected with epoetin~     alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or~     mobility among elderly.~   "
245706|NCT00337428|"~     Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus~     [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined~     diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic~     and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.~   "
245707|NCT00337415|"~     A Research Study to Evaluate the Effectiveness and Tolerability of MK0354 vs Placebo (an~     inactive look alike pill) in Lipid (fat) Altering in Patients with dyslipidemia (a disorder~     of lipids in the blood)~      This is an early phase trial and some specific protocol information is proprietary and not~     publicly available at this time. (Full information is available to trial participants).~   "
245708|NCT00337402|"~     Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients.~     Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on~     effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France~     (observational study)~   "
245709|NCT00337389|"~     To compare the progression-free survival time (PFS) in patients treated with 5-FU modulated~     with CoFactor (plus bevacizumab) to 5-FU modulated with leucovorin (plus bevacizumab) in~     patients with Metastatic Colorectal Cancer.~   "
245710|NCT00337376|"~     Rapamycin is a drug that has been approved by the Food and Drug Administration (government)~     for use in patients receiving a kidney transplant to prevent the patient's body from~     rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has~     not been approved at this time for the treatment of cancer. Abraxane is a new form of~     chemotherapy that has been approved by the Food and Drug Administration for the treatment of~     metastatic breast cancer, and is a promising drug that is being evaluated in clinical trials~     for treatment of other cancers. This is a phase I study designed to find out if different~     doses of Rapamycin, when combined with Abraxane, are safe and well tolerated.~   "
245711|NCT00337350|"~     We propose an eight-week, double-blind, placebo-controlled trial of rosiglitazone in~     schizophrenia subjects treated with clozapine using Bergman's Minimal Model (MINMOD)~     intravenous glucose tolerance test. Bergman's Minimal Model analysis with frequent sampled~     intravenous glucose tolerance test (FSIVGTT) provides a sensitive and reliable method to~     measure glucose effectiveness, insulin secretion and insulin sensitivity. The MINMOD~     determines the relationship between insulin sensitivity, insulin secretion and the degree of~     obesity and can be used to study drug effects upon these variables.~   "
245712|NCT00337337|"~     We aim to investigate the beneficial effect of adding grain fiber to daily rice meal in type~     2 diabetic patients. We anticipate this intervention will improve glycemia and lipid profile~     in these patients.~   "
245713|NCT00337324|"~     We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain~     in patients with painful diabetic neuropathy.~   "
245714|NCT00337298|"~     The purpose of this study is to compare the effect of two antihypertensive drugs on retinal~     vessel diameter in young type 1 diabetics. The retinal vessel analyzer (RVA) was used to~     investigate how the drugs affected vessel diameter, when the subjects were exposed to an~     increase in blood pressure, induced by isometric muscle contraction and when they were~     stimulated by flickering light.~   "
245715|NCT00337285|"~     The purpose of this study is to assess the long-term safety and efficacy of three NRP104~     doses of 30 mg, 50 mg, or 70 mg, administered at the same time daily, in the treatment of~     adults with ADHD.~   "
245717|NCT00337259|"~     Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with~     chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma.~     Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have~     anti-lymphoma activity. To the investigators' knowledge, there has been no trial of~     gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the~     role of gemcitabine in marginal zone lymphoma.~   "
245718|NCT00337246|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and~     mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can~     block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Giving combination chemotherapy together with rituximab may kill more cancer cells. It~     is not yet known whether giving combination chemotherapy together with rituximab is more~     effective than combination chemotherapy alone in treating chronic lymphocytic leukemia.~      PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy~     with or without rituximab works in treating patients with previously treated chronic~     lymphocytic leukemia.~   "
245719|NCT00337233|"~     RATIONALE: Yoga may improve symptoms and quality of life and reduce stress in patients with~     ovarian cancer or breast cancer and may help them live more comfortably.~      PURPOSE: This clinical trial is studying how well yoga works in controlling symptoms and~     reducing stress in women with ovarian cancer or breast cancer.~   "
245720|NCT00337220|"~     The purpose of this study is to determine if analysis of urine samples for specific markers~     can predict transplant rejection in people who have received kidney transplants.~   "
245721|NCT00337207|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with~     recurrent or progressive glioma.~   "
245722|NCT00337194|"~     This randomized phase II trial studies the side effects and how well giving monoclonal~     antibody SGN-30 together with combination chemotherapy works in treating patients with~     Hodgkin lymphoma that has returned after a period of improvement or did not respond to~     previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of~     cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine~     hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination~     chemotherapy may kill more cancer cells and shrink tumors.~   "
245723|NCT00337181|"~     This protocol will study the clinical course of HIV-infection among volunteers who have~     received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and~     AIDSVAX B/E prior to HIV-1 infection. The study will assess whether those who received the~     experimental vaccine combination have a slower progression of HIV disease compared to those~     who received the placebo injection.~   "
245724|NCT00337168|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving cytarabine together with clofarabine~     works in treating patients with relapsed or refractory acute lymphoblastic leukemia.~   "
245725|NCT00337155|"~     The purpose of this study is to evaluate the effectiveness of the investigational~     radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone~     metastases that no longer respond to hormonal treatment.~   "
245726|NCT00337142|"~     Infants to diabetic mothers (IDM) are at risk for developing hypoglycemia after birth.~     Glucose level follow ups are recommended to each IDM. However, there are no recommendations~     as to how long this follow up should be performed for, nor are there safe glucose levels~     that allow stopping glucose monitoring.~      The aim of the study is to retrospectively follow up glucose levels among IDMs in order to~     find risk factors for developing hypoglycemia and determine time and glucose levels that~     would permit monitoring cessation.~   "
245727|NCT00337129|"~     RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well E7389 works in treating patients with~     metastatic or recurrent head and neck cancer.~   "
245728|NCT00337116|"~     This is a randomized, double blind, placebo-controlled study, clinical trail designed to~     evaluate the efficacy safety and superiority of intravenous boluses of isosorbide dinitrate~     for the relief of acute anginal pain episodes in acute coronary syndrome patients in~     comparison with the usual manner of S/L isosorbide dinitrate .~   "
245729|NCT00337103|"~     The purpose of this study is to compare E7389 versus capecitabine in patients with locally~     advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This~     is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive~     either E7389 or capecitabine on a one-to-one ratio.~   "
245730|NCT00337090|"~     The study will examine which dose of YM178 is best in terms of efficacy, safety and~     tolerability compared to placebo and compared to tolterodine, a marketed product.~   "
245731|NCT00337077|"~     This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog)~     works in treating patients with metastatic prostate cancer that did not respond to hormone~     therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~   "
245756|NCT00336713|"~     The purpose of the study is to evaluate the long-term efficacy and safety of Saredutant in~     patients with depression. The primary objective is to evaluate the efficacy and safety of~     Saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive~     symptoms in outpatients with major depressive disorder who achieved an initial response to 12~     weeks of open-label treatment with Saredutant.~   "
245732|NCT00337064|"~     The standard treatment for women with invasive breast cancer is local excision follow by~     whole breast radiation. The local recurrence rates are low, side effects are low, and the~     cosmetic outcome is excellent. The treatments, however, need to be given daily for 5 1/2 to 6~     1/2 weeks, making the treatment difficult, particularly for the elderly and for women who~     need to travel long distances for the therapy. The goal of this study is to determine the~     toxicity and efficacy of giving the radiation in a shorter time, using higher daily doses of~     radiation.~      The risk of recurrence in the elderly population is lower, and since majority of recurrences~     occur close to the area where the tumor previously was, it is hypothesized that radiation to~     that area of the breast would be sufficient to obtain low risk of recurrence. When a smaller~     volume of tissue is treated, more radiation can be given daily, and therefore the treatment~     can be shortened. The risk of side effects increases as the dose per daily treatment~     increases. Therefore, the goal is to study the short term side effects, long term side~     effects, and cosmetic outcome of daily radiation using higher daily doses for shorter period~     of time. We will also follow the recurrence rate. Because less of the breast tissue will be~     treated, there may be a small increased risk of recurrence. Because the higher fraction size~     can result in more side effects we will be using intensity modulated radiation (IMRT). IMRT~     is the most advanced individually tailored radiation treatment technique that results in the~     least amount of side effects. It allows tight monitoring of the dose in the untreated breast.~      Seventy five women diagnosed with stage I breast cancer will participate. Participants must~     have a lumpectomy, clear margins and no lymphovascular invasion to be eligible. A treatment~     planning CT scan will be obtained. If the lumpectomy cavity can be clearly delineated, an~     IMRT plan will be generated with predefined strict dose requirement criteria. The patients~     will be treated once daily, 5 days a week, for a total of 10 treatments (instead of standard~     28-33). The patients will be evaluated for toxicity weekly during the treatment, and weekly~     for additional 4 weeks. At each of these evaluations, they will fill out a short 10 minute~     questionnaire detailing their side effects. Follow-up will continue every 3 months for 3~     years, and every 6 months for 2 more years. At each of these follow-ups a short questionnaire~     will be filled out by the patients detailing any toxicity, as well as their perception of the~     cosmetic outcome. A cosmesis questionnaire will be also be filled out by the evaluating~     physician before radiation, at 6, 12, 18, and 24 months, and yearly for 3 more years. A total~     of 5 years of follow-up is planned. Participants will also have the option of consenting to~     the photograph portion of the study. Those who do will have photographs taken of their~     breasts (excluding faces) at the time they complete the cosmetic questionnaire, to evaluate~     the cosmetic outcome.~   "
245733|NCT00337051|"~     Renal transplantation is characterized by ischemia-reperfusion lesions in allograft. In a~     previous study, Julier and al. (Anesthesiology 2003) have demonstrated that sevoflurane~     reduces glomerular lesions in kidney of patients undergoing a cardiovascular surgery and~     présenting with ischemia-reperfusion phenomena.~      The purpose of the study is to evaluate the effects of sevoflurane on the recovery of renal~     graft function in patients after kidney transplantation.~      This study will be a randomized, double blinded, controlled clinical trial and 120 patients~     undergoing renal allograft transplantation will be included.~      Patients will be divided into 2 groups: one group of patients who will receive sevoflurane~     (evaluated treatment) for anaesthesia and the other one who will receive propofol (reference~     treatment).~      We will evaluate renal function for one year after transplantation. Ours results will confirm~     or not that sevoflurane protects kidney function from ischemia-reperfusion lesions.~   "
245734|NCT00337038|"~     Our aim is to examine the influence of blood pressure and glycemic control together with~     N-acetylcystein utilization on the endothelia function of hypertensive diabetic patient.The~     study population will include 50 diabetic patient with uncontrolled hypertention that will be~     recruited from the Hypertension Clinic of Soroka University Medical Center.~   "
245735|NCT00337012|"~     This study focuses on possible mechanism mediating duloxetine effects on painful physical~     symptoms in patients suffering from MDD. Our hypothesis is based on the assump¬tion of dual~     impairment of the somatosensory system in these patients. Hypalgesia to phasic experimental~     pain may be due to diminished spinal and brainstem transmission. Hyperalgesia may be~     at¬tributed to increased interoceptive perception (somatic complaints, especially those~     consist¬ing in pain) due to sensitisation or lack of inhibition of the interceptive~     perception. These ef¬fects seem to be mediated by specific brain regions (e.g. the right~     insula). The investigators intent to test if duloxetine effects on these somatic complaints,~     especially pain complaints are due to a nor¬malization of these interceptive alterations~     which have been reported to be associated with depressive symptoms. The investigators~     hypothesize that treatment with duloxetine will normalize patho¬logical activation patterns~     (as assessed by fMRI) associated with increased interoceptive perception.~   "
245736|NCT00336986|"~     This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At~     least 14 to a maximum of 40 patients, who have not previously received treatment for their~     stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.~   "
245737|NCT00336973|"~     This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in~     adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis~     who have had an inadequate response to treatment with an anti-TNF agent. The study will~     consist of a screening period, a treatment period, and an observation period. All subjects~     will begin in the screening period (the length of which is dependent on the previous anti-TNF~     agent treatment). Approximately 100 eligible subjects will receive treatment from Day 0~     through Day 168.~   "
245738|NCT00336960|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor~     and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such~     as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to~     kill tumor cells. Celecoxib may make tumor cells more sensitive to radiation therapy. Giving~     celecoxib together with fluorouracil and radiation therapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving celecoxib together with fluorouracil~     and radiation therapy works in treating patients with stage II or stage III rectal cancer~     that can be removed by surgery.~   "
245739|NCT00336947|"~     RATIONALE: Drugs used in chemotherapy, such as S-1 and tegafur-uracil, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving S-1 or tegafur-uracil after surgery, chemotherapy, biological therapy,~     and/or radiation therapy may kill any remaining tumor cells. It is not yet known whether S-1~     is more effective than tegafur-uracil in treating head and neck cancer.~      PURPOSE: This randomized phase III trial is studying S-1 to see how well it works compared~     with tegafur-uracil in treating patients with previously treated stage III or stage IV head~     and neck cancer.~   "
245740|NCT00336934|"~     RATIONALE: Pomegranate extract may keep prostate cancer from growing in patients with rising~     prostate-specific antigen (PSA) levels after surgery or radiation therapy for localized~     prostate cancer.~      PURPOSE: This randomized trial is studying how well pomegranate extract works in treating~     patients with rising PSA levels after surgery or radiation therapy for localized prostate~     cancer.~   "
245741|NCT00336921|"~     The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the~     return to successful voiding after removal of the catheter following a first episode of acute~     urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).~   "
245742|NCT00336908|"~     This study is a blinded, randomized, controlled prospective trial comparing immune response~     (sepsis, inflammatory response, pulmonary vasoconstriction) in 2 groups of infants less than~     3-month old receiving pre and post cardiopulmonary bypass surgery. The infants will receive 1~     out of the 2 following intravenous lipid preparations: Soybean Oil (n-6), or a combination of~     Medium Chain Triglyceride i.e. coconut oil, Long Chain Triglyceride i.e. Soybean Oil, and~     Fish Oil (MCT:LCT:FO). There will be 16 subjects in each group.~   "
245743|NCT00336895|"~     The objective of this study is to determine the tolerability and safety of Myfortic in liver~     transplant patients. Patients receiving CellCept who have GI side effects will have CellCept~     discontinued and changed to Myfortic (Myfortic is a new drug similar to CellCept, except it~     is enteric-coated). Our hypothesis is that Myfortic has less GI side effects and will,~     therefore, be tolerated better than CellCept and also that Myfortic will have a comparable~     effectiveness to CellCept.~   "
245744|NCT00336882|"~     Severe traumatic brain injury is associated with an increased production of free radicals~     causing brain damage. First line treatment of these patients aims to maintain cerebral~     perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties~     that need to be confirmed when used in these patients. The main objective of this study is to~     evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress~     following severe traumatic brain injury.~   "
245745|NCT00336869|"~     The theme of this Morehouse-Emory Partnership Program focuses on elucidating the etiologic~     basis of ethnic differences in obesity-related CVD and discovering new intervention~     strategies to ameliorate CV health in all communities. The proposed Program uses a~     multi-disciplinary strategy to systematically characterize ethnic differences in~     obesity-related CVD by drawing upon the fields of physiology, psychology, biochemistry,~     vascular biology, public health, nursing and clinical medicine.~   "
245746|NCT00336856|"~     Research Hypothesis: Subjects in the study population who are treated with cetuximab in~     combination with irinotecan will have higher response rates than subjects treated with~     irinotecan alone.~   "
245747|NCT00336843|"~     In order to improve the clinical result of high-dose chemotherapy and autologous stem cell~     transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning~     regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan,~     cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell~     non-Hodgkin's lymphoma.~   "
245748|NCT00336830|"~     The purpose of this study is to determine the effect of a pre-discharge written personal~     endorsement to the patient by the patient's attending cardiologist or cardiac surgeon (MD~     endorsement) to take part in the Cardiac Rehabilitation and Secondary Prevention (CR)~     program, in addition to the standard CR referral, compared to the standard CR referral alone,~     on CR program enrollment within 2 months of index hospital discharge following admission for~     myocardial infarction, unstable angina, coronary angioplasty, or coronary artery bypass.~   "
245749|NCT00336817|"~     The objective of this study is to compare the safety and efficacy of Myfortic with CellCept~     in liver transplant patients. Myfortic and CellCept are both immunosuppressive~     (anti-rejection) drugs. CellCept is commonly used after liver transplantation but~     gastrointestinal (GI) side effects are very common, sometimes necessitating in its~     discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our~     hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable~     effectiveness to CellCept.~   "
245750|NCT00336791|"~     Primary Objectives:~        1. To prospectively evaluate the predictive accuracy of a previously discovered gene~          expression profile-based test to foretell pathologic complete response (pCR) to~          preoperative paclitaxel/FAC (5-fluorouracil, doxorubicin, cyclophosphamide) chemotherapy~          for stage I-III breast cancer.~        2. To evaluate if our genomic predictive test is specific to the paclitaxel/FAC regimen or~          it also predicts increased sensitivity to FAC only chemotherapy.~      Secondary Objectives:~        1. To discover a molecular profile that is associated with pCR after FAC chemotherapy alone~        2. To establish a prospectively collected gene expression profile data bank of breast~          cancer for future studies~        3. To compare the pCR rates between patients who receive 6 courses FAC and those who~          receive sequential paclitaxel /FAC chemotherapies.~   "
245751|NCT00336778|"~     We hypothesize that a simple bridging ARV regimen that tends to select for virus with a low~     replicative capacity may tend to stabilize CD4 cell counts and HIV viral load and might be an~     option to consider in patients with MDR HIV.~      This strategy will provide them with the bridge they desperately need so that they can await~     the development of new therapies that when used in combination will give them the best chance~     in achieving complete virologic suppression.~   "
245752|NCT00336765|"~     The purpose of this study is to assess the safety and tolerability of the multiple receptor~     tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given~     orally daily to adults with advanced solid tumors.~   "
245753|NCT00336752|"~     The purpose of the study is to compare functional outcomes and recovery following surgical~     and non surgical treatment of potentially unstable , isolated fibula fractures. Secondary~     objectives are to compare the re-operation rate, time to union and complications between the~     two treatment groups.~      The primary research questions:~        1. Does surgery provide a better functional outcome compared to non operative treatment of~          undisplaced, unstable fractures?~        2. Do patients with these fractures return to activities faster after operative or non~          operative treatment?~        3. Are complications more common with operative or non operative care?~   "
245754|NCT00336739|"~     The purpose of this study is to determine whether cinacalcet will increase gastric acid~     secretion in healthy volunteers.~   "
245755|NCT00336726|"~     Traumatic Brain Injury (TBI) is a neurologic disorder cuased by physical trauma to the brain.~     Neuroendocrine abnormalities in these patients have been reported, including central~     hypogonadism within hours of the insult and eventual recovery of the~     hypothalamic-pituitary-gonadal axis with recovery of cognitive function to baseline. This~     pilot study will measure hormonal level of neuroendocine function at the time of TBI and~     various time points during recovery.~   "
245757|NCT00336700|"~     Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with~     adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed~     by single agent erlotinib for a total of 12 months.~   "
245759|NCT00336674|"~     In people with type 1 diabetes the beta cells of the pancreas no longer make insulin because~     the body's immune system has attacked and destroyed the beta cells. It is thought that~     exposure of the mucous membranes to insulin may cause act like a vaccine effect whereby~     protective immune cells are stimulated and these then counteract the bad immune cells that~     damage the beta cells. This study aims to determine if intranasal insulin can protect beta~     cells and stop progression to diabetes in individuals who are at risk.~   "
245760|NCT00336661|"~     This is a pivotal, prospective, randomized, blinded, multicenter study to evaluate two~     treatments of photodynamic disinfection in adults with chronic periodontal disease. The study~     is expected to enroll a total of up to 105 subjects.~   "
245761|NCT00336648|"~     Primary Objective:~      1. To assess resectability rate in patients undergoing gemcitabine plus Avastin-based~     chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas.~      Secondary Objectives:~        1. To assess disease free survival and overall survival~        2. To assess margin resection rate (R0 vs. R1) in these patients~        3. To assess patterns of failure~   "
245762|NCT00336635|"~     The currently available stock of smallpox vaccine would be insufficient in the face of an~     incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine is urgently~     needed because previous manufacturing methods using calf lymph are no longer acceptable in~     the view of current standards. Recently, CJ corporation in Republic of Korea has developed~     cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5~     cells. The aim of this phase 1 clinical trial were to assess safety, reactogenicity, and~     immunogenicity of CJ-50300.~   "
245763|NCT00336622|"~     The purpose of this randomized clinical trial was to examine the efficacy of a splinting~     (fabricated versus off-the-shelf splint)and exercise (nerve and tendon gliding versus no~     exercise) interventions to alter the clinical course of Carpal Tunnel Syndrome (CTS). We~     hypothesized that the fabricated splint with nerve and tendon gliding exercises condition~     would yield the best functional outcomes at 4 and 8 weeks posttesting.~   "
245764|NCT00336609|"~     Observational (non-drug) study to look at the risks and burden of mucositis (sores) involving~     the mouth, throat and intestines in patients receiving chemotherapy and radiation therapy~     treatment for various cancer types.~   "
245765|NCT00336596|"~     The purpose of the present, randomized, controlled multicenter phase III trial is to~     investigate the safety and efficacy of continuous 1-hour insonation of occluded middle~     cerebral artery with 2 MHz TCCS in stroke patients treated with intravenous tissue~     plasminogen activator (t-PA) within 3 hours after symptom onset.~   "
245766|NCT00336583|"~     Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide,~     methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this~     ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma~     patients.~   "
245767|NCT00336570|"~     Principal Investigator: Arshed A. Quyyumi, MD~      To establish normal values by age, race, and gender of novel markers of risk in healthy~     subjects necessary to predict precise risk of cardiovascular disease in an individual.~   "
245768|NCT00336557|"~     An observational study to determine the impact of multiple neutralizing antibody (NAb) tests~     on treatment patterns compared to the usual care of MS patients receiving high-dose IFN~     therapy.~   "
245769|NCT00336544|"~     The purpose of this study is to compare the efficacy and safety of cethromycin to~     clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP).~   "
245770|NCT00336531|"~     The purpose of this study is to investigate whether the prophylactic use of itraconazole is a~     better option than empirical use of itraconazole in the management (prevention and treatment)~     of fungal infection associated with high-dose chemotherapy and autologous hematopoietic stem~     cell transplantation in children with high-risk solid tumor.~   "
245771|NCT00336518|"~     Primary objective is to measure sustained viral response given to continuation or~     prolongation of combined Pegasys&Copegus treatment~      Secondary objective is to measure histological response given to continuation or prolongation~     of combined Pegasys&Copegus treatment measured by non-invasive methods~   "
245772|NCT00336505|"~     The purpose of this study is to compare the efficacy of cethromycin to clarithromycin for the~     treatment of mild to moderate community-acquired pneumonia (CAP).~   "
245773|NCT00336492|"~     The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade)~     in children with moderately to severely active ulcerative colitis.~   "
245774|NCT00336479|"~     Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa~     2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV)~     ribonucleic acid (RNA) levels~   "
245775|NCT00336466|"~     Context: Neurocognitive dysfunction complicates coronary artery bypass graft surgery.~     Neurocognitive dysfunction is a measurable problem with thinking. Erythropoietin may be a~     neuroprotectant.~      Objective: To investigate the feasibility and safety of three doses of human recombinant~     erythropoietin to reduce neurocognitive dysfunction in coronary artery bypass graft patients.~   "
245776|NCT00336453|"~     The purpose of this study was to evaluate dose-related safety, reactogenicity and~     immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza~     vaccine, administered to healthy children aged 6 to 59 months.~   "
245777|NCT00336427|"~     We hypothesize that pregnant women are at baseline risk for carrying community-acquired MRSA,~     but also have frequent contact with healthcare workers which may put them at risk for~     hospital-acquired MRSA carriage. Our study aimed to identify the colonization rate of women~     in active labor and whether transmission to infants may occur.~   "
245778|NCT00336414|"~     This is a 5-year project, involving 185 partners from 46 countries (110 in 21 EU States and~     75 in 25 extra-EU States), with a randomised clinical trials (RCT) in juvenile systemic lupus~     erythematosus (JSLE): 5-year phase III single-blind, RCT in children with newly diagnosed,~     WHO class III, IV JSLE proliferative nephritis: PDN and oral cyclophosphamide (CYC) versus~     high dose intravenous (iv) CYC versus intermediate dose iv CYC, followed by maintenance with~     azathioprine.The trial is aimed to find out the treatment regimen associated with the lowest~     occurrence of flare and the lowest drug related toxicity.~   "
245779|NCT00336401|"~     Non-cardiac surgery is associated with significant cardiac morbidity and mortality. Volatile~     anesthetics have a cardioprotective effects which results in preservation of left ventricular~     function and lower troponin I levels. Lower troponin release has been correlated with better~     long term event free survival in both cardiac and non cardiac surgery. A recently completed~     meta-analysis suggests that sevoflurane is a superior volatile agent. The evidence of a~     cardioprotective effect in non-cardiac surgery is lacking. Base on the current literature, we~     intend to evaluate the protective potential of sevoflurane versus propofol anesthesia in high~     risk patients undergoing elective non-cardiac procedures.~      Hypothesis: The use of Sevoflurane as a general anesthetic reduces postoperative troponin~     release, the incidence of myocardial infarction and/or long term morbidity in patients at low~     to moderate risk of postoperative cardiac complications, who are undergoing noncardiac~     surgery.~   "
245780|NCT00336388|"~     The purpose of this study is to investigate the impact of rapid diagnostic tests (RDTs) in~     the context of a newly implemented malaria case management guidelines using artemisinin-based~     combination therapy on the malaria prescribing practices of health care workers in Kenya.~   "
245781|NCT00336375|"~     The purpose of this explorative clinical trial is to study parasite population dynamics,~     diversity and clearance kinetics of Plasmodium falciparum as well as determination of the~     molecular mechanisms associated with drug resistance during the early phase of~     artemether-lumefantrine treatment when the drug intake is either accompanied with or without~     intake of fatty food. The hypothesis is that intake of fatty food together with~     artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of~     early selection of genetic markers related to drug resistance. The study population is~     children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled~     children will be randomly allocated to either intake of a fatty meal or not together with the~     study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses~     according to bodyweight. Study participants will be admitted during the study period (3~     days)to allow close supervision and detailed blood sampling.~   "
245782|NCT00336362|"~     Beta thalassemia major is a serious genetic disease of the blood. Treatments are limited, and~     although a bone marrow transplant from a compatible donor can be curative, only a limited~     percentage of individuals with this disease have a matched donor available. A long-term goal~     of study researchers is to develop a gene transfer process as a method of curing beta~     thalassemia major. Gene transfer involves obtaining blood stem cells from an individual,~     adding a normal globin gene to the stem cells, and putting the cells back into the~     individual.~      Before gene transfer methods can be attempted in individuals with beta thalassemia major, a~     safe method of obtaining blood stem cells needs to be developed. The purpose of this study is~     to investigate the safety and feasibility of collecting peripheral blood stem cells (PBSC)~     from individuals with beta thalassemia major. Research participants will be given G-CSF~     (filgrastim) for several days to increase the number of stem cells in the blood, a process~     called mobilization. After mobilization, participants will undergo a procedure called~     apheresis to remove the white blood cells. Researchers in the laboratory will purify the stem~     cells from the mixture and test methods of putting a normal globin gene into the stem cells.~     Half of the participants will receive hydroxyurea (HU) prior to G-CSF mobilization. HU is~     used in splenectomized patients to attempt to reduce the risk of clotting during~     mobilization. In non-splenectomized patients, HU is given in an attempt to decrease the size~     of the spleen.~   "
245783|NCT00336349|"~     Effective treatment of neuropathic foot pain in diabetic patients is very important to~     improve their quality of life. There are many medications used to reduce the diabetic~     neuropathic pain, including anticonvulsants, anti-depressants or analgesics, but none is~     universally satisfied. A few previous studies employing BOTOX® i.d. injection for control of~     trigeminal neuralgia, post-herpes neuralgia indicate that BOTOX® was effective in controlling~     neuropathic pain. Intradermal injection of BOTOX® to the dorsum of the foot in diabetics~     should be effective in controlling diabetes-associated polyneuropathic pain of the foot.~   "
245784|NCT00336336|"~     INTRODUCTION While pharmacological treatments specifically targeted to the cardio-circulatory~     system have been largely investigated, scanty controlled data are available concerning the~     role of dietary and metabolic approaches in the management/outcome of patients with heart~     failure. A large scale, randomized, clinical trial is proposed to test the effects of (a) n-3~     PUFA and (b) a lipid lowering agent on top of the best recommended treatments for heart~     failure.~      STUDY DESIGN~      The GISSI-HF is a prospective, multicenter, randomized, double blind, placebo controlled~     study, with randomized allocation of patients with a clinical diagnosis of heart failure to:~      Randomization 1 (R1): n-3 PUFA 1 g daily vs corresponding placebo; Randomization 2 (R2):~     rosuvastatin 10 mg daily vs corresponding placebo.~      OBJECTIVES OF THE STUDY PRIMARY OBJECTIVES~      To demonstrate that, in patients with heart failure treated at the best of recommended~     therapies, long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than~     the corresponding placebo in the reduction of:~        -  All-cause mortality~        -  All-cause mortality or hospitalizations for cardiovascular reason~      OTHER END-POINT MEASURES OF EFFICACY~      To assess that long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective~     than corresponding placebo in the reduction of:~        -  Cardiovascular mortality~        -  Cardiovascular mortality or hospitalizations for any reason~        -  Sudden cardiac death~        -  Hospitalizations for any reason~        -  Hospitalizations for cardiovascular reasons~        -  Hospitalizations for congestive heart failure~        -  Myocardial infarction~        -  Stroke~   "
245785|NCT00336323|"~     This study will provide preliminary data on the dose and dose interval related effects of~     intravitreally administered Avastin on retinal thickness and visual acuity in subjects with~     Diabetic Macular Edema (DME) to aid in planning a phase 3 trial.~      In addition, this study will provide preliminary data on the safety of intravitreally~     administered Avastin in subjects with DME.~   "
245786|NCT00336310|"~     The purpose of this study is to determine whether a new-brand of repaglinide is effective in~     the treatment of type 2 diabetes patients.~   "
245815|NCT00335920|"~     The purpose of this study is to evaluate the efficacy and safety of an intratympanic~     continuous two-week application of dexamethasone compared to placebo using a temporarily~     implanted catheter in patients with severe to profound sudden sensorineural hearing loss and~     insufficient recovery after initial systemic prednisolone therapy.~   "
245787|NCT00336297|"~     Recent reviews have identified the need for additional high quality exploratory and~     evaluative research to understand 1) the actual impact on all women of instituting mass~     screening procedures versus using indicator-based approaches to identifying woman abuse and~     2) the extent to which early identification through screening -- either universal or~     indicator-based is effective in preventing or ameliorating important outcomes. This is a~     critical first step in developing a larger randomized controlled trial (RCT) which examines~     the effectiveness of screening in preventing woman abuse, improving quality of life and other~     associated outcomes. This study prepares for the RCT by testing the optimal method of~     administration for the two screening instruments that will be used in the RCT. The~     administration formats are: computer-based screen, paper and pencil screen and face-to-face~     screen. They study will also determine recruitment rates.~   "
245788|NCT00336284|"~     This study is a multi-center, prospective and randomized trial. The primary objective of this~     study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely~     reduce the number of regularly scheduled office follow-up visits, compared to the~     conventional method of implantable cardioverter defibrillator (ICD) follow-up.~   "
245789|NCT00336271|"~     In this study, participants will be eligible to participate in a paid research study that~     will examine the effects of regular coffee drinking. The study takes approximately 2 hours~     total, 55 min. on 2 separate days. Participants will be asked to do computer tasks and drink~     only coffee provided to them during the study.~   "
245790|NCT00336258|"~     The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT~     detected by US-Doppler and procoagulant microparticles in a selected group of cancer patients~     suffering from an advanced stage of the disease.~      An attempt will be made to determine whether there is a correlation between this prevalence~     and various clinical and laboratory parameters.~   "
245791|NCT00336245|"~     A randomized trial of the intrauterine contraceptive device (IUD) versus user's choice~     hormonal contraception (injectable progestins or oral contraceptive pills) among~     HIV-infected, recently post-partum women in Lusaka, Zambia.~   "
245792|NCT00336232|"~     The purpose of this study is to learn how the body responds to different amounts of vitamin K~     in the diet in order to understand the roles that vitamin K may have in the body. We also~     need to determine if older adults need more or less vitamin K in their diet compared to~     younger adults in order to maintain normal body stores of vitamin K.~   "
245793|NCT00336219|"~     The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux~     disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An~     endoscopy will be performed at study start and study end. During the study, the patients will~     complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire).~     The study duration consists of a baseline period (8 days) and treatment period (28 days).~     Pantoprazole (tablet) will be administered once daily at one dose level. The study will~     provide further data on safety and tolerability of pantoprazole.~   "
245794|NCT00336206|"~     The aim of the study is to evaluate if the treatment with Alemtuzumab (after I or II line~     chemotherapy) administered for 6 weeks followed by 4 months maintenance treatment compared to~     a control group can reduce disease activity/residual disease and thereby delay the~     reoccurrence of the CLL disease.~   "
245795|NCT00336193|"~     This proposal examines the impact of an augmented competency based approach to training of~     home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff~     performance, fidelity to the program model, and family outcomes relative to child~     maltreatment and early behaviors associated with youth violence. The central premise~     underlying the proposed study is that the augmented competency based curriculum and clinical~     consultation to supervisors will improve nurses' knowledge and skills in working with~     families, which in turn, will lead to greater fidelity to the home visit guidelines (i.e.,~     quality implementation), which in turn, will result in better maternal and child health~     outcomes.~   "
245796|NCT00336180|"~     The purpose of this trial is to test the effectiveness of a classroom-based prevention~     program (HealthWise: Learning Life Skills for Young Adults) to reduce the risk of HIV/AIDS~     and STIs, as well as substance use, among adolescents in one area of South Africa.~   "
245797|NCT00336167|"~     The purpose of this study is to determine whether bezafibrate is effective in the treatment~     of the muscular adult form of carnitine palmitoyltransferase 2 deficiency~   "
245798|NCT00336154|"~     Epidermolysis Bullosa(EB) is an inherited bullous disease. Tetracycline is believed to have~     anti inflammatory properties. 20 patients with EB older than 13 years will be treated for 4~     months with tetracycline or placebo. After one month of wash out they will be treated for~     additional 4 m with placebo or tetracycline. The patients will be examined each month to~     estimate bulla formation,rate of healing .~   "
245799|NCT00336141|"~     This protocol will investigate the use of vorinostat (suberoylanilide hydroxamic acid - SAHA)~     in combination with infusional 5-FU and leucovorin for the treatment of metastatic colorectal~     cancer patients who have failed standard 5FU regimens.~   "
245800|NCT00336128|"~     Behavioral intervention at Kindergarten setting aiming at increased fruit and vegetable~     consumption, decreased intake of high energy foods, snacks, sweets, increased intake of~     water/low energy drinks, decreased intake of high energy drinks. Physical activity should be~     more than 1 hour/day and TV/media consumption less than 1 hour/day.~      Main questions are:~      Do children differ in intervention and control kindergartens according to their nutrition~     behaviour? Do children in the intervention kindergartens have a higher physical training than~     such in the control kindergartens? Data were collected with a standardised questionnaire.~      Do children differ in intervention and control kindergartens according to their body mass~     index?~   "
245801|NCT00336115|"~     The purpose of this study is to determine if pertussis (whooping cough) vaccine is safe and~     produces an appropriate immune response against pertussis in blood and marrow transplant~     patients.~   "
245802|NCT00336102|"~     RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan~     treatment and may help patients live more comfortably.~      PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with~     newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo~     chemotherapy compared to how often it happens in healthy volunteers.~   "
245803|NCT00336089|"~     RATIONALE: An exercise program or health education program may help relieve fatigue and pain~     and improve the quality of life in women who are breast cancer survivors. It is not yet known~     whether an exercise program is more effective than a health education program or no program~     in reducing fatigue and pain in women who are breast cancer survivors.~      PURPOSE: This randomized clinical trial is studying an exercise program to see how well it~     works in reducing fatigue and pain compared to a health education program or no program in~     women who are breast cancer survivors.~   "
245804|NCT00336076|"~     Mastocytosis is a disorder characterized by presence of excessive numbers of mast cells in~     skin, bone marrow and internal organs. It can affect both children and adults, males and~     females and individuals from all ethnic backgrounds, although precise demographic information~     about the affected populations is not available as it is a rare disorder. Mastocytosis in~     children is generally limited to the skin and follows a self limited course, while it is a~     disorder of the hematopoietic stem cell associated with somatic mutations of the c-kit gene~     in most patients with adult-onset of disease. There is no known curative therapy for most~     patients with systemic mastocytosis. Recent research studies identified several subtypes of~     disease with distinct clinical and pathologic features, however, a precise understanding of~     the incidence as well as molecular pathology of different disease subtypes is lacking. This~     study aims to examine molecular and cellular pathological aspects of disease in patients with~     mastocytosis and correlate findings with clinical presentation and prognosis. Patients will~     undergo a routine history and physical examination, and diagnostic tests will be ordered as~     dictated by each patient's clinical presentation. Blood and bone marrow will be obtained for~     diagnostic and research purposes. Genetic analysis of the c-kit gene regulating mast cell~     growth and differentiation will be performed. It is hoped that findings obtained from this~     study will help to design novel therapies for mastocytosis and other disorders in which mast~     cells play a critical role.~   "
245805|NCT00336063|"~     This phase I trial studies the side effects and best dose of vorinostat when given together~     with azacitidine in treating patients with nasopharyngeal cancer or nasal natural killer~     T-cell lymphoma that has recurred (come back) at or near the same place as the original~     (primary) tumor, usually after a period of time during which the cancer could not be detected~     or has spread to other parts of the body. Drugs used in chemotherapy, such as vorinostat and~     azacitidine, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Vorinostat and~     azacitidine also may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth. Giving vorinostat together with azacitidine may kill more cancer cells.~   "
245806|NCT00336050|"~     Asthma can be caused by many factors, including mold, pollen, and other airborne pollutants.~     The purpose of this study is to evaluate the effect that air pollution has on the long-term~     severity of asthma symptoms and lung function in children.~   "
245807|NCT00336024|"~     This randomized phase III trial is studying two different combination chemotherapy regimens~     to compare how well they work when given before a peripheral stem cell transplant in treating~     young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or~     high-risk medulloblastoma. Drugs used in chemotherapy work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) together with a peripheral stem cell transplant~     may allow more chemotherapy to be given so that more tumor cells are killed. It is not yet~     known which combination chemotherapy regimen is more effective when given before a peripheral~     stem cell transplant in treating supratentorial primitive neuroectodermal tumors or~     medulloblastoma.~   "
245808|NCT00336011|"~     To evaluate short-term and long-term effects by MR imaging on the technical and functional~     status of Medtronic pacemakers.~   "
245809|NCT00335998|"~     Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. 3-AP~     may also stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP and cisplatin may~     make tumor cells more sensitive to radiation therapy. Giving 3-AP and external-beam radiation~     therapy together with cisplatin may kill more tumor cells. This phase I trial is studying the~     side effects and best dose of 3-AP when given together with external-beam radiation therapy~     with or without cisplatin in treating patients with gynecologic cancer~   "
245810|NCT00335985|"~     This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy~     of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based~     on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition,~     to assess the safety of GB-0998.~   "
245811|NCT00335972|"~     We propose to test whether intraoperative administration of dexmedetomidine will reduce~     hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic~     requirements in patients undergoing carotid endarterectomy.~   "
245812|NCT00335959|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy~     together with radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine~     together with radiation therapy works in treating patients with stomach cancer that can be~     removed by surgery.~   "
245813|NCT00335946|"~     The purpose of this study is to determine the effects of non-needle electro-acupuncture on~     mild to moderate anxiety. The hypothesis is that this style of treatment will reduce state~     anxiety and not trait anxiety as measured by the Spielberger STAI test.~   "
245814|NCT00335933|"~     Gabapentin and pregabalin are treatments for some types of neuropathic pain, including~     postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a~     day for effective pain control. The purpose of this study is to determine whether a new~     gabapentin tablet, which only needs to be taken once or twice a day, is safe and effective~     for the treatment of postherpetic neuralgia.~   "
245817|NCT00335894|"~     Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two~     parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and~     the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).~   "
245818|NCT00335881|"~     Persistence of seroprotective antibody concentrations & immunological memory shown by the~     ability to mount a response to a challenge dose of HBV vaccine~   "
245819|NCT00335868|"~     RATIONALE: PHA-739358 may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well PHA-739358 works in treating patients with~     chronic myelogenous leukemia that relapsed after imatinib mesylate or c-ABL therapy.~   "
245820|NCT00335855|"~     The purpose of this study is to evaluate the safety, effectiveness, and tolerability, of the~     Pharma-Pen(TM) intramuscular (IM) and subcutaneous (SC) auto-injector systems used by~     untrained users to self-administer Influenza vaccines as compared to standard IM injections~     administered by a licensed healthcare professional (e.g. a nurse). Participants will be 120~     healthy men and women aged 18 - 50 years who have not received influenza vaccine for at least~     four years and who have no experience in giving intramuscular or subcutaneous injections.~     Subjects will be randomly placed in one of three treatment types. They will receive one~     injection of commercially available Influenza vaccine and will be evaluated over the course~     of six months.~   "
245821|NCT00335829|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs~     directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together~     with chemoembolization may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with~     chemoembolization works in treating patients with liver cancer that cannot be removed by~     surgery.~   "
245822|NCT00335816|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Fluorouracil may also make tumor cells more sensitive to radiation therapy.~     Leucovorin calcium may protect normal cells from the side effects of chemotherapy, and it may~     help fluorouracil work better by making tumor cells more sensitive to the drug. Giving~     radiation therapy together with chemotherapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving radiation therapy together with~     fluorouracil with or without combination therapy works in treating patients who are~     undergoing surgery for stage II or stage III rectal cancer.~   "
245823|NCT00335803|"~     Chronic daily headache has been classified into several categories. One category is of sudden~     onset and is called New Daily Persistent Headache (NDPH). Another category of daily headache~     evolves gradually and is called Transformed Migraine (TM). This research study is being~     conducted to compare people with these two kinds of daily headache in order to improve our~     understanding of these conditions.~   "
245824|NCT00335790|"~     Autism is a neurodevelopmental disorder currently affecting as many as 1 out of 166 children~     in the United States. Autism is considered by many to be a permanent condition with little~     hope for improvement. Treatment for autism is centered on special schooling and behavioral~     therapy; medical science currently has little to offer. Recent research has discovered that~     some autistic individuals have decreased blood flow to the brain, evidence of~     gastrointestinal and brain inflammation, increased markers of oxidative stress, and a~     relative mitochondrial dysfunction. Hyperbaric oxygen therapy (HBOT) can compensate for~     decreased blood flow by increasing the oxygen content of plasma and body tissues and can even~     normalize oxygen levels in ischemic tissue. In addition, animal studies have shown that HBOT~     has potent anti-inflammatory effects and reduces oxidative stress. Furthermore, recent~     evidence demonstrates that HBOT increases the production of mitochondria and mobilizes stem~     cells from human bone marrow, which may aid recovery in neurodegenerative diseases. Based~     upon these findings, it is hypothesized that HBOT will improve symptoms in autistic~     individuals.~      Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic~     children. We recently completed a prospective pilot trial using HBOT in 18 children which~     demonstrated significant clinical improvements in autistic children on several standardized~     scales. Most of the scales were parent-rated, although some were rated by teachers. However,~     parents were not blinded to the fact that their children received HBOT and evaluation of the~     children was through parent-rated scales, either of which could lead to bias. There was no~     placebo or control group. Therefore, the improvements found in this prospective study could~     have been due merely to chance or the natural development of the children. To determine if~     HBOT improves symptoms in autistic children, a double-blind controlled study is needed.~   "
245825|NCT00335777|"~     This is a research study looking at Migranal (study drug) in the treatment of two migraine~     attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us~     al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a~     headache. It has been noted in several studies that in patients with migraine, seventy nine~     percent of the patients experienced allodynia on the facial skin on the same side as the~     headache. Understanding more about allodynia may help us understand how the pain system works~     in migraine.~      This study will compare the differences, if any, in attacks treated early with study drug (at~     1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one~     attack early and one attack late for this study. If the first attack you treat is early (at 1~     hour following onset of throbbing pain) then the second attack you treat should be late (at 4~     hours following onset of throbbing pain).~      It is hoped that this study will provide information on the use of Migranal in subjects who~     have cutaneous allodynia. The results from this study may be used in the development of~     larger clinical trials. The study drug is a medication that is taken in the form of nasal~     spray.~   "
245826|NCT00335764|"~     This phase I/II trial is studying the side effects and best dose of erlotinib, tipifarnib,~     and temsirolimus when given together with sorafenib and to see how well they work in treating~     patients with recurrent glioblastoma multiforme or gliosarcoma. Sorafenib, erlotinib,~     tipifarnib, and temsirolimus may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor~     cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib,~     tipifarnib, or temsirolimus may kill more tumor cells.~   "
246055|NCT00332735|"~     The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for~     outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be~     compared.~   "
245827|NCT00335751|"~     RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine~     the extent of cancer and predict a patient's response to treatment and help plan the best~     treatment.~      PURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates~     treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.~   "
245828|NCT00335738|"~     This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they~     work compared to observation only in treating patients who have undergone surgery for newly~     diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and~     etoposide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery,~     no additional treatment is needed for the tumor until it progresses. In this case,~     observation may be sufficient.~   "
245829|NCT00335725|"~     Purpose of the study is the comparative evaluation of the clinical efficacy and of the~     general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs~     Gonal-F® Serono) when administered in patients undergoing ICSI~   "
245830|NCT00335712|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of~     ONO-5129 in patients with type 2 diabetes mellitus.~   "
245831|NCT00335699|"~     The primary objective of this study is to compare the effect of rosuvastatin 10mg with~     atorvastatin 10mg in the percentage reduction of LDL-C in Subjects with metabolic syndrome~     after 6 weeks of treatment.~   "
245832|NCT00335686|"~     The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the~     mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption~     of nucleoside analogues.~   "
245833|NCT00335673|"~     -  To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and~          ≤ 130/80 mm Hg in diabetic patients.~        -  To determine percentage of patients achieving blood pressure control according to their~          profile (naïve, switch, patient history, etc…) at the end of the trial.~   "
245834|NCT00335660|"~     The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1)~     antagonist, in subjects with Idiopathic Detrusor Overactivity.~   "
245835|NCT00335647|"~     RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of fluphenazine and~     to see how well it works in treating patients with refractory advanced multiple myeloma.~   "
245836|NCT00335634|"~     The purpose of this study is to explore patient and partner experiences with sexual~     dysfunction following radical prostatectomy, in order to understand its effects on sexual and~     non-sexual intimacy. This will enable us to provide assistance in the future to individuals~     experiencing similar circumstances.~   "
245837|NCT00335621|"~     Some patients with chronic obstructive pulmonary disease (COPD) take nebulised treatments to~     ease the symptom of breathlessness, including the drug ipratropium. Nebulised bronchodilator~     drugs are taken up to 4 times through the day, and this can take up to 15 minutes each time.~     Although the treatment isbe effective, patients report that the time taken to set-up and use~     the nebuliser can be a disincentive to regular use. By contrast, an inhaler device is easy to~     use following appropriate instruction, and takes only a few seconds to administer. Inhaled~     tiotropium is a once daily treatment taken by inhaler which has been shown to be effective in~     COPD. We wish to assess whether inhaled Tiotropium as effective as nebulised ipratropium in~     patients with stable chronic obstructive pulmonary disease.~   "
245838|NCT00335595|"~     The purpose of this study is to compare the free time to disease progression of combination~     therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus~     capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease~     progression or a premature drop out of the study.~   "
245839|NCT00335582|"~     In Canada 1 patient in 200 dies within 30 days of an operation. More than half of these~     deaths are the direct result of a heart related complication. This cause of death happens 4~     times more often than in the same people who do not have an operation. We do not have an~     effective way to stop these heart attacks. Stress causes the heart rate and the blood~     pressure to go up which causes the heart to work harder and may be the reason for some heart~     attacks. One group of drugs that stops the heart from working harder and decrease the number~     of heart related complications are BETA-BLOCKERS. We wish to add another drug, which has been~     shown to reduce heart rate and blood pressure, will reduce the number of heart attacks after~     an operation. CLONIDINE has been shown to reduce heart attacks after operations. Since we~     know it is not a good idea to stop beta-blockers we want to see if giving clonidine as well~     as a beta-blocker is safe and has the desired effect of decreasing the number of heart~     attacks. We want to find out how good the combination of these two drugs are at decreasing~     the number of heart attacks.~      Hypothesis: The addition of clonidine to chronic b-blockade will reduce mortality and cardiac~     morbidity among intermediate-to-high risk patients undergoing non-cardiac surgery.~   "
245840|NCT00335569|"~     The purpose of the study is to evaluate the clinical equivalence and the general tolerability~     of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when~     administered to patients undergoing IVF.~   "
245841|NCT00335556|"~     This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or~     surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     combination chemotherapy together with radiation therapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed.~   "
245855|NCT00335348|"~     This study has two main aims. The first is to assess whether Dexamethasone can increase the~     number of patients with who respond to Velcade.~      The second aim of this study is to see whether treating patients with relapsed multiple~     myeloma with Velcade and Dexamethasone for a longer period of time extends the time that the~     myeloma is under control.~   "
245842|NCT00335543|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy~     together with radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill~     any tumor cells that remain after surgery. It is not yet know whether giving chemotherapy~     together with radiation therapy before surgery is more effective than surgery alone in~     treating pancreatic cancer.~      PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and cisplatin~     together with radiation therapy before surgery works compared to surgery alone in treating~     patients with localized pancreatic cancer that can be removed by surgery.~   "
245843|NCT00335517|"~     The purpose of the study is to help determine the appropriate dose of DepoDur for use in~     spinal surgery. The study will also assess the safety of this drug in this patient~     population.~   "
245844|NCT00335504|"~     This randomized phase II trial is studying atorvastatin calcium to see how well it works~     compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in~     patients at increased risk of developing colorectal neoplasia. Chemoprevention is the use of~     certain drugs or substances to keep cancer from forming, growing, or coming back. The use of~     atorvastatin calcium, oligofructose-enriched inulin, or sulindac may stop cancer from forming~     in patients at increased risk of colorectal neoplasia. It is not yet known whether~     atorvastatin calcium, oligofructose-enriched inulin, or sulindac are more effective than a~     placebo in preventing cancer in patients at increased risk of developing colorectal~     neoplasia.~   "
245845|NCT00335491|"~     RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer~     survivors. It is not yet known whether exercise is more effective than standard therapy in~     improving mobility and reducing fatigue and/or weakness in older cancer survivors.~      PURPOSE: This randomized clinical trial is studying exercise to see how well it works~     compared to standard therapy in improving mobility and reducing fatigue and/or weakness in~     older cancer survivors.~   "
245846|NCT00335478|"~     RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in~     patients with cancer.~      PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia~     and fever in patients with cancer.~   "
245847|NCT00335465|"~     The primary objective of the present study is to assess changes of myocardial glucose uptake~     (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with~     type 2 diabetes and idiopathic left ventricular dysfunction (LVD).~      The secondary objectives of the study are: assessment of changes of myocardial~     microcirculation at rest and during adenosine stimulation using PET; assessment of changes in~     myocardial structure and function evaluated by magnetic resonance imaging (MRI); assessment~     of glycaemic control by measurement of HbA1c, fasting blood glucose and insulin levels;~     assessment of safety (adverse event profile, laboratory data).~   "
245848|NCT00335452|"~     The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin~     (two doses) will decrease the risk of ischemic complications (cardiac death (CV death),~     myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).~   "
245849|NCT00335439|"~     The study will evaluate the efficacy of prophylactic administration of the topical~     nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid~     macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent~     cause of decreased vision after uncomplicated cataract surgery and can result in irreversible~     sight reduction. The investigation will involve a comparison arm and a treatment arm with~     both sets of patient populations being evaluated for CME with ophthalmologic examinations and~     optical coherence tomography (OCT) measurements. The objective is to elucidate the role of~     NSAID drops in preventing CME after cataract surgery.~   "
245850|NCT00335426|"~     The purpose of this study is to determine if spinal manipulative therapy can affect cognitive~     processing as determined by performance on a Stroop task. It is specifically hypothesized~     that number of errors and response times will decrease as a result of spinal manipulative~     therapy.~   "
245851|NCT00335413|"~     To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive~     type 1 diabetic patients.~   "
245852|NCT00335400|"~     To prepare the eye for cataract surgery, drugs must be given to the eye to allow for surgery~     to take place. Traditionally, dilating drops and drops containing NSAIDs (to control~     inflammation) are given to the patient well in advance of surgery at repeated time intervals.~     As well, a gel containing lidocaine is applied to the eye just prior to surgery to~     anesthetize (reduce pain and feeling) in the area of the eye. Although effective, the~     procedure is time-consuming and costly for nursing staff. Recently, a few hospitals have~     reported success in mixing the pupil-dilating and NSAID drops with the lidocaine gel,~     creating an anesthetic dilating gel. Although success has been reported, there have been no~     studies to clearly demonstrate that the anesthetic dilating gel is as effective at dilating~     the pupil and reducing sensitivity of the cornea during surgery than the traditional methods~     of drops and gel. It is possible that the dilating gel is less effective due to slower~     diffusion of drugs into the eye. The study will compare the effectiveness of the anesthetic~     dilating gel with the standard pre-operative pharmacologic regimen for cataract surgery.~     Stability (maintaining effectiveness over time) and contamination of the study gel will also~     be assessed. If the dilating gel is shown to be as effective in regards to pupil dilation and~     corneal anesthesia, while maintaining stability and sterility over time, hospitals can be~     encouraged to use such a anesthetic dilating gel routinely during pre-operative procedures~     before cataract surgery.~   "
245853|NCT00335374|"~     This is a multicenter, 6 months open label safety extension study for all patients who are~     willing and eligible to continue from the pivotal, double-blind S308.3.003 trial~   "
245854|NCT00335361|"~     The study is to evaluate a device for male reproductive sterilization and determine if this~     device is successful at blocking the sperm.~      Ninety subjects from two centers in the United Stated will be followed closely for 24 months.~      If you are someone interested in a vasectomy, you may be eligible to participate in this~     clinical study.~   "
245894|NCT00334828|"~     The purpose of this study is to compare eritoran tetrasodium and placebo in patients with~     severe sepsis and to demonstrate a reduction of mortality from all causes.~   "
245856|NCT00335335|"~     CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses~     x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins~     throughout the body.~      VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart~     arteries. The pictures it produces of the heart and its blood vessels will be reviewed and~     compared to those obtained during the catheter-based coronary angiography to see if the CTA~     shows the same blockages.~   "
245857|NCT00335322|"~     In treatment naïve HIV infected subjects, combination antiretroviral therapy including~     efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral~     efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with~     tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and~     abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.~   "
245858|NCT00335309|"~     The purpose of this study is to evaluate the effectiveness of maxillary sinus saline~     irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy~     alone in the management of chronic rhinosinusitis, a prospective randomized controlled trial.~   "
245859|NCT00335296|"~     The primary objective of this study is to demonstrate the safety and performance of the PFx~     Closure System when utilized for patients with PFOs suffering from cryptogenic stroke,~     transient ischemic attack, migraine or decompression illness.~   "
245860|NCT00335283|"~     The purpose of this study is to determine whether aggressive acid suppression with~     Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors~     of response based on clinical and physiologic parameters.~   "
245861|NCT00335270|"~     The purpose of this study is to evaluate the antiretroviral efficacy, safety, and~     tolerability of fos-amprenavir boosted with either of two doses of ritonavir (RTV) when~     administered in combination with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose~     combination) in a once-daily regimen over 96 weeks in ART-naïve, HIV-infected adults~   "
245862|NCT00335257|"~     The study compares the short- and long-term risks of a 24-day regimen of a~     drospirenone-containing oral contraceptive with the risks of established oral contraceptives~     in a study population that is representative for the actual users of the individual~     preparations.~   "
245863|NCT00335244|"~     This clinical trial will determine the safety and effectiveness of intravenous L-citrulline~     in children undergoing cardiopulmonary bypass during heart surgery. Participants will be~     randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in~     it).~      Citrulline is a protein building block in the body that can convert into another substance,~     nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in~     the lungs can be an important surgical problem; it may also lead to problems following~     surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased~     time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The~     hypothesis of this study is that perioperative supplementation with intravenous citrulline~     will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the~     postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical~     ventilation.~   "
245864|NCT00335231|"~     Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an~     infection of the anterior chamber of the eye caused by bacterial contamination and~     colonization through surgical incisions. Bacteria are thought to originate mainly from the~     patient's skin and studies show that bacteria are commonly found in the anterior chamber~     following surgery. However, innate immune defences are usually able to control and eliminate~     bacterial growth before postoperative endophthalmitis occurs. Also, due to the low incidence~     of postoperative endophthalmitis, it is difficult to accurately evaluate preventative~     methods. This study will examine the efficacy of topical preoperative administration of~     gatifloxacin (a new fourth generation fluoroquinolone antibiotic) on reduction of bacterial~     contamination of the anterior chamber following cataract surgery. If the antibiotic is shown~     to lower bacteria count in cultures from anterior chamber fluid, it has the potential to~     lower the incidence of postoperative endophthalmitis.~      Patients undergoing cataract surgery will be notified and asked to participate in the study~     by the physician in advance of the surgery, provided they do not possess any exclusion~     criteria. The participants will be randomly split into two groups; one group will receive~     topical application of gatifloxacin prior to surgery, while the other group will receive no~     eye drops. During surgery, a small sample of anterior chamber fluid will be removed from the~     eye and cultured in both broth and enrichment media for all subjects. Bacterial growth, i.e.,~     colony forming units (CFUs), will be used as an indicator of the bacterial contamination of~     the fluid.~   "
245865|NCT00335218|"~     The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on~     abdominal fat distribution measured by magnetic resonance imaging.~   "
245866|NCT00335205|"~     We hypothesize that depressed patients who have not responded to their current antidepressant~     medication will respond to the addition of ropinirole to their current regimen at a rate~     better than placebo.~   "
245867|NCT00335192|"~     The purpose of this study is to evaluate if there are pharmacokinetic interactions between~     the NRTI 3TC and ABV, and the TDF nucleotide. For this purpose, the intracellular and plasma~     levels of 3TC and ABV will be compared in patients given these nucleosides with TDF and 30~     days after the interruption of the TDF.~   "
245868|NCT00335179|"~     Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes~     that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin~     cells should also be visible using a special microscope. This study examines both types of~     changes.~   "
245869|NCT00335166|"~     This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment~     with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to~     this study is planned as a separate protocol for patients who are willing and eligible to~     participate.~   "
245870|NCT00335153|"~     The primary objective of this study will be to provide further evidence of the long-term~     safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in~     participants with advanced Parkinson's disease (PD) and severe motor fluctuations.~   "
246954|NCT00320567|"~     The purpose of this study is to evaluate the effect of norgestimate/ethinyl estradiol on~     lumbar spine (L1-L4) and total hip bone mineral density (BMD) in pediatric subjects with~     anorexia nervosa.~   "
245871|NCT00335140|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others~     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,~     such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving rituximab together with combination chemotherapy may kill~     more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.~   "
245872|NCT00335114|"~     Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome.~     Contact lens wearers frequently suffer from dry eye syndrome. The purpose of this study is to~     evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye~     symptoms in contact lens wearers~   "
245873|NCT00335101|"~     The study is to evaluate and compare the effects on kidney function of three iodinated~     contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr)~     concentrations up to three days after CM administration.~   "
245874|NCT00335088|"~     The hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal~     sac and eye lids before intraocular surgeries. Patients admitted for various intraocular~     surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin~     and povidone iodine or povidone iodine alone before surgery. Lacrimal sac and eye lid~     cultures will be obtained before the local therapy and just before surgery.~   "
245875|NCT00335075|"~     The primary purpose of the study is to evaluate the efficacy and safety of temozolomide~     compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic~     astrocytoma.~   "
245876|NCT00335062|"~     Graves' disease, the most common form of hyperthyroidism in children, is caused by~     Thyrotropin (TSH) Receptor Antibodies (TRAbs) that mimic the action of TSH. The disease leads~     to significant morbidity in children both due to the prolonged course of antithyroid~     medication often required for sustained immunological remission and the high risk of relapse~     when medication is withdrawn. The ability to predict which patients are most likely to fail~     medical management would greatly improve the choice of therapy. In the past, large goiter~     size, age at diagnosis, increased biochemical severity, and decreased body mass index have~     all been associated with a poorer prognosis, but these clinical indicators lack sensitivity~     and specificity. Preliminary data suggest that the new TRAb assays are both sensitive and~     specific for the measurement of TRAbs in children with Graves' disease. In addition,~     variation in these antibodies over time is not the same in all patients. The goal of this~     proposal will be to prospectively follow children with newly diagnosed Graves' disease and~     use microarray technology to determine if there are genes whose expression differ in patients~     who respond to medical therapy versus those who will need more definitive therapy earlier in~     their disease.~   "
245877|NCT00335049|"~     At this time, we do not know what causes a child to become more nearsighted (myopic). STAMP~     will help us better understand nearsightedness in children. Children will be randomly chosen~     to wear regular glasses (single vision lenses) or no-line bifocal glasses (progressive~     addition lenses) for the first year of the study. All children will wear regular glasses for~     the second year of the study. STAMP will compare how the eye changes shape in the two groups~     to help us understand why children become nearsighted. The two theories of myopia progression~     that are being evaluated are based on different factors. One theory is based on environmental~     factors such as extended near work while the other theory is based on genetically coded~     factors.~   "
245878|NCT00335036|"~     This is a randomized, prospective clinical trial comparing 2 different types of implantable~     cardioverter defibrillator (ICD) leads in children and patients with congenital heart~     disease. ICD lead survival in this patient group is particularly suboptimal, and lead~     extraction is technically difficult and carries a substantial morbidity risk. Recently,~     improved ICD lead designs have been released and are currently being utilized in patients.~     The main aim of the study is to determine if either type of lead performs better in terms of~     implantation electrical characteristics, long-term survival without breaking, and ease of~     extractability.~   "
245879|NCT00335023|"~     Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed~     and developing countries. The most important treatment of PPH is red blood cell (RBC)~     transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum~     haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially~     to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess~     the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether~     RBC transfusion is necessary.~   "
245880|NCT00335010|"~     The aim of the present study was to investigate if NTG, administered intravenously during~     gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation~     and reduce the incidence of postoperative leakage.~   "
245881|NCT00334997|"~     RATIONALE: Endoscopic surgery is a less invasive type of surgery for laryngeal cancer and may~     have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to~     kill tumor cells. It is not yet known whether endoscopic surgery is more effective than~     radiation therapy in treating laryngeal cancer of the glottis.~      PURPOSE: This randomized phase II trial is studying endoscopic surgery to see how well it~     works compared with radiation therapy in treating patients with stage 0, stage I, or stage II~     laryngeal cancer of the glottis.~   "
245882|NCT00334984|"~     RATIONALE: Glutamine may help prevent mucositis, or mouth sores, in patients receiving~     chemotherapy for sarcoma. It is not yet known whether glutamine is more effective than a~     placebo in preventing mucositis in patients receiving chemotherapy for sarcoma.~      PURPOSE: This randomized clinical trial is studying glutamine to see how well it works~     compared to a placebo in preventing oral mucositis in patients receiving chemotherapy for~     sarcoma.~   "
245948|NCT00334126|"~     The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of~     the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to~     placebo in patients who are acutely ill with symptoms of schizophrenia.~   "
246955|NCT00320554|"~     The purpose of this study is to determine the motion characteristics of the foot and ankle~     with a durometer as a method of measurement.~   "
245883|NCT00334971|"~     The purpose of the study is to understand how the ovarian follicle (the fluid filled~     structure in the ovary that contains the egg) makes estrogen and other hormones during normal~     aging, in women with different ethnic backgrounds, and in Fragile X premutation carriers.~      During reproductive aging, estradiol levels are increased, a phenomenon that may be related~     to increased aromatase activity. The investigators' own preliminary data suggest that~     estradiol is increased in African-American women compared to Caucasian women, which may also~     be related to aromatase activity. In addition, the investigators have examined female fragile~     X premutation carriers who still have regular menstrual cycles and have demonstrated evidence~     of early ovarian aging compared to age-matched controls.~      **WE ARE RECRUITING ONLY WOMEN WITH FRAGILE-X PREMUTATION**~   "
245884|NCT00334958|"~     The primary objective of this study is to evaluate the effect of rufinamide on total partial~     seizure frequency in adolescent and adult patients with refractory partial onset seizures~     currently inadequately treated with a maximum of three stable antiepileptic medications.~     Secondary objectives are to evaluate the effect of rufinamide on secondary and exploratory~     outcomes, to confirm the safety profile of rufinamide, and to assess the relationship between~     rufinamide plasma concentration and efficacy.~   "
245885|NCT00334945|"~     The purpose of this study is to evaluate the effect of growth hormone treatment on phosphorus~     levels in the body. Phosphorus is an important mineral for bone growth. It is well known that~     growth hormone treatment improves bone density and bone mineral content. The amount of~     phosphorus is maintained by the kidneys. Fibroblast Growth Factor 23 has recently been~     recognized to help kidneys control phosphate levels.~   "
245886|NCT00334932|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and~     melphalan, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride~     liposome and melphalan together with bortezomib may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of doxorubicin~     hydrochloride liposome , melphalan, and bortezomib and to see how well they work in treating~     patients with relapsed or refractory stage I, stage II, or stage III multiple myeloma.~   "
245887|NCT00334919|"~     The purpose of this study is to determine if the naturopathic Anti-Inflammatory Diet results~     in reduced inflammation and a better response by the immune system when compared to a~     standard diabetic diet based on the current American Diabetes Association guidelines.~   "
245888|NCT00334906|"~     The purpose of this study is to characterize the progression of disease using volumetric MRI~     techniques and cognitive outcome measures in patients with moderate dementia of the~     Alzheimer's type treated with open-label memantine.~   "
245889|NCT00334893|"~     This phase II trial is studying how well eribulin mesylate works in treating patients with~     recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Drugs used~     in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing.~   "
245890|NCT00334880|"~     The purpose of this study is to evaluate the safety and effectiveness of NRP104 administered~     as a daily morning dose (30, 50, and 70mg/day) compared to placebo in adults (18-55 years of~     age inclusive) diagnosed with moderate to severe Attention Deficit Hyperactivity Disorder~     (ADHD).~   "
245891|NCT00334867|"~     RATIONALE: Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide,~     ifosfamide, etoposide, and topotecan, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery~     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~     Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is~     not yet known which combination chemotherapy regimen is more effective in treating Ewing's~     sarcoma.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy and topotecan~     to see how well they work compared with combination chemotherapy alone in treating patients~     with newly diagnosed localized Ewing's sarcoma.~   "
245892|NCT00334854|"~     RATIONALE: Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination~     chemotherapy with or without radiation therapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after~     surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase III trial is studying how well giving ifosfamide and doxorubicin,~     radiation therapy, and/or surgery works in treating young patients with localized soft tissue~     sarcoma.~   "
245893|NCT00334841|"~     Leptin, a circulating hormone expressed abundantly in adipose tissue, has been reported to be~     a satiety factor. In addition, it has been shown to increase during pregnancy in maternal~     blood, parallel to increase in body fat mass, to correlate with fetal body weight gain and to~     fall down to basal levels after delivery.~      Little is known about leptin levels in pregnant women with preexisting or gestational~     diabetes and their relationship with fetal and postnatal growth and perinatal complications.~      Therefore, the proposed study aims to understand and characterize the role of leptin in~     gestational diabetes mellitus as well as the relationship between leptin, cytokines and the~     pathophysiological complications during diabetic pregnancy. Specifically, we will evaluate 60~     pregnant women both in Germany and in Israel and evaluate serum levels and mRNA of leptin,~     cytokines (inflammatory as well as Th1 and Th2) and correlate them to maternal changes of~     body weight and birth weight in women of various degrees of glucose tolerance and with~     various degrees of metabolic control during pregnancy; relationship between serum and~     umbilical cord vein concentrations of leptin, cytokines and metabolic variables; placental~     expression of leptin, leptin receptor, selected cytokines, GLUT1 and 4 and relationship to~     leptin in serum and umbilical cord plasma; comparison between all above parameters of German~     and Israeli pregnant women.~      The results of this new and systematic study will shed light on the role of leptin and~     cytokines in the development of glucose disturbances during pregnancy and the perinatal~     outcome of women with gestational or preexisting diabetes mellitus.~   "
245895|NCT00334815|"~     This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in~     treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be~     removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel,~     work in different ways to stop the growth of [cancer/tumor] cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may~     interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug~     (combination chemotherapy) together with radiation therapy and bevacizumab may kill more~     tumor cells.~   "
245896|NCT00334802|"~     To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients~     with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline~     regimen~   "
245897|NCT00334789|"~     This phase I trial is studying the side effects and best dose of belinostat when given~     together with isotretinoin in treating patients with metastatic or unresectable solid tumors.~     Belinostat may stop the growth of tumor cells by blocking blood flow to the tumor and by~     blocking some of the enzymes needed for cell growth. Isotretinoin may cause solid tumor cells~     to look more like normal cells, and to grow and spread more slowly. Giving belinostat~     together with isotretinoin may be an effective treatment for metastatic or unresectable solid~     tumors.~   "
245898|NCT00334776|"~     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help~     the body build an effective immune response to kill melanoma cells.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients~     with metastatic melanoma.~   "
245899|NCT00334763|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells~     by blocking blood flow to the tumor. Giving radiation therapy together with chemotherapy and~     monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving radiation therapy together with~     chemotherapy and bevacizumab works in treating patients with recurrent, unresectable or stage~     III or stage IV non-small cell lung cancer.~   "
245900|NCT00334750|"~     This descriptive, non-interventional study will collect information on the presence of risk~     factors in newly diagnosed ocular hypertension and open-angle glaucoma patients in Canada.~   "
245901|NCT00334737|"~     Infants born prematurely do not increase production of the primary red cell growth factor,~     erythropoietin (Epo), and often develop an anemia called the anemia of prematurity. The~     anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of~     Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is~     successful in treating the anemia of prematurity. A slightly modified, long-acting version of~     rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in~     increasing hematocrit (red blood cell levels) in adults. In addition to its red cell~     stimulating properties, recent evidence has shown that rHuEpo is protective in the developing~     or injured brain. We have designed a randomized, masked, placebo-controlled study to~     determine the safety and short and long term efficacy of darbepoetin. At this time,~     darbepoetin has been studied primarily in adults and pediatric patients, but there is~     evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well.~     It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize~     that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight~     will result in increased reticulocyte counts and decreased transfusions compared to placebo;~     and 2. The administration of darbepoetin will be associated with an increased mental~     developmental index at 18-22 months compared to placebo.~   "
245902|NCT00334724|"~     The purpose of this study is to determine whether blood pressure control by home blood~     pressure monitoring exerts beneficial cardioprotective effects rather than by clinic blood~     pressure monitoring in elderly patients.~   "
245903|NCT00334711|"~     The purpose of this study is to investigate whether patients with diabetes due to Kir6.2~     mutations can be treated with sulfonylurea medication rather than insulin, and if this is the~     case to investigate the mechanism for sulfonylurea response.~   "
245904|NCT00334698|"~     The aim of this study is to assess the efficacy on nasal congestion and other allergic~     symptoms and the onset of action of an oral combination of cetirizine and pseudoephedrine in~     comparison to the single substances under controlled pollen exposure in an Environmental~     Challenge Chamber (ECC).~   "
245905|NCT00334685|"~     The purpose of this study is to determine the effectiveness of adjunctive treatment of~     pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN~   "
245906|NCT00334672|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of~     hemophagocytic lymphohistiocytosis cells, either by killing the cells or by stopping them~     from dividing. Giving more than one drug (combination chemotherapy) may kill more~     hemophagocytic lymphohistiocytosis cells. A donor stem cell transplant may be able to replace~     blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Cyclosporine and~     methotrexate may stop this from happening.~      PURPOSE: This phase III trial is studying how well combination chemotherapy followed by a~     donor stem cell transplant works in treating patients with hemophagocytic~     lymphohistiocytosis.~   "
245907|NCT00334659|"~     The purpose of this study is to confirm that apricitabine does not induce any clinically~     significant effect upon electrocardiogram (ECG) parameters at doses consistent with the~     maximum exposure expected to occur in clinical practice.~   "
245908|NCT00334646|"~     This study is designed to evaluate the potential pharmacokinetic interaction between oral~     GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.~   "
245909|NCT00334633|"~     We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than~     treatment with metronidazole~   "
245910|NCT00334620|"~     The study aimed to investigate effects of radon (plus CO2) baths on RA in contrast to~     artificial CO2 baths in RA rehabilitation.~      134 patients of an in-patient rehabilitative programme were randomly assigned to the groups.~     Outcomes were limitations in occupational context/ daily living (main outcome), pain,~     medication, etc. measured before start, after end of treatment, and up to a year thereafter.~      Superiority of radon treatment was found regarding reduced limitations in daily living until~     12 months after end of treatment. Steroid consumption and NSAIDs were significantly reduced.~   "
245911|NCT00334607|"~     The aim of this this study is to confirm absence of immune interference between HRV vaccine~     and routine infant vaccinations currently in use in the USA.~   "
245912|NCT00334594|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells~     that remain after surgery.~      PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium~     together with cisplatin followed by surgery with or without radiation therapy works in~     treating patients with malignant pleural mesothelioma.~   "
245913|NCT00334581|"~     Primary objective:~        -  To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in~          hypertensive patients with diabetes and microalbuminuria.~      Secondary objectives:~        -  To determine how well irbesartan 300mg is tolerated versus 150mg~        -  To determine the percentage of patients reaching the blood pressure target of 130/80~          mmHg~   "
245914|NCT00334568|"~     Clinical features in patients with the familial early onset forms and the sporadic forms of~     Alzheimers disease are similar, although the course of deterioration may be different. It~     would be very informative to examine the drug response of patients with Alzheimers disease by~     a certain genotype to find evidence favouring genotype-specific drug responses that may~     indicate genetically defined phenotypic differences in alzheimers disease.~   "
245915|NCT00334555|"~     This study is designed to try to find the best method of partner notification and treatment~     for partners of women with trichomonas~   "
245916|NCT00334542|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of simvastatin may keep cancer from coming back in women who are at~     high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or~     stage I, stage II, or stage III breast cancer.~      PURPOSE: This phase II trial is studying how well simvastatin works in preventing a new~     breast cancer in women at high risk for a new breast cancer after undergoing surgery for~     ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.~   "
245917|NCT00334529|"~     This study will determine if oseltamivir (Tamiflu(Registered Trademark)) is safe and~     effective given less frequently than the currently prescribed dose of twice a day for 5 days~     to people who have the flu, and once a day for up to 6 weeks in people who have been exposed~     to someone else with flu and want to prevent getting it themselves. This study will see if~     the drug can be given once every other day instead of daily if given with another medication~     called probenecid (Benemid(Registered Trademark) or Probalan(Registered Trademark)).~      Healthy people 18 years of age and older may be eligible for this study. Candidates are~     screened with a medical history, physical examination, and blood and urine tests.~      Participants are randomly assigned to one of the following regimens for 2 weeks: 1) 75~     milligrams (mg) of oseltamivir once a day; 2) 75 mg of oseltamivir once every other day plus~     500 mg probenecid four times a day; or 3) 75 mg of oseltamivir once every other day plus 500~     mg probenecid twice a day. All medications are taken by mouth. On study day 0, subjects have~     the following baseline procedures: measurement of vital signs, review of medical and~     medication history, physical examination, blood draw and urine test. They also receive the~     first dose of oseltamivir or oseltamivir and probenecid. In addition, they undergo the~     following procedures as follows:~        -  Days 1 and 4: Vital signs; review of clinical symptoms, side effects and medications~          taken; urine testing and blood draw.~        -  Day 8: Same as day 1 plus count of study medication.~        -  Day 14: Same as day 8 plus pharmacokinetic study to measure the amount of oseltamivir~          and probenecid in the blood. For this test, a catheter is inserted into an arm vein and~          blood samples are collected through the catheter before taking the study medications, at~          the time the medications are taken, and again at 15 minutes, 30 minutes, 45 minutes and~          1, 1.5, 2, 4, 8 and 12 hours after the medication is taken. The catheter is then~          removed. This is the last day to take the study medication.~        -  Day 15: Blood draw for 24-hour (post medication) blood sample.~        -  Day 16: Blood draw for 48-hour (post medication) blood sample.~        -  Days 21 and 28: Same as day 1.~   "
245918|NCT00334516|"~     This study will test whether primary lateral sclerosis (PLS) and amyotrophic lateral~     sclerosis (ALS) affect parts of the brain responsible for thinking, planning, memory and~     emotion.~      Healthy volunteers 18 years of age and older and patients with PLS and ALS may be eligible~     for this study.~      Participants undergo the following procedures:~        -  Rating motor function: Subjects are asked to contract certain muscles in the face, arms~          and legs, to tap their finger on a keyboard rapidly, to walk 20 feet, and to read a~          paragraph out loud.~        -  Electroencephalography (EEG): The electrical activity of the brain (brain waves) is~          recorded while subjects tap their finger very slowly. For this test, electrodes are~          placed on the scalp using a cap or an adhesive substance. A conductive gel is used to~          fill the space between the electrodes and the scalp to ensure good contact.~        -  Surface electromyography (EMG): The electrical activity of the muscles is measured.~          Electrodes filled with a conductive gel are taped to the skin over the muscle tested.~        -  Neuropsychological testing: Testing may include questionnaires, pen-and-paper or~          computerized tests, and motor tasks.~        -  Magnetic resonance imaging (MRI): MRI uses a strong magnetic field and radio waves to~          produce images of the brain. The subject lies on a table that slides into the scanner.~          Scanning time varies from 20 minutes to 3 hours, with most scans lasting 45-90 minutes.~   "
245919|NCT00334503|"~     The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in~     patients with Type2 Diabetes Mellitus treated with Biguanide.~   "
245920|NCT00334490|"~     Post-operative pulmonary hypertension is a risk factor for right ventricular failure and an~     increasing cause of morbidity and mortality in patients undergoing high-risk cardiac surgery.~     Several treatments have been used to treat and reduce post operative pulmonary hypertension.~     Unfortunately none of these treatments are approved for use in this condition and only one~     (inhaled nitric oxide) is specific enough to pulmonary hypertension to not cause dangerous~     low blood pressure in the rest of the body. Sadly, inhaled nitric oxide is difficult and~     expensive to use, and can cause lung damage. Sildenafil citrate is quite specific to the lung~     vessels, is easy to administer and does not easily cause low blood pressure in other areas of~     the body. We hypothesize that oral sildenafil 12.5mg will decrease the baseline (pre-dose)~     mPAP by at least 20% compared with a placebo.~   "
245921|NCT00334477|"~     The purpose of this study is to check the safety and efficacy of a pde5 inhibitor, tadalafil,~     is a special group of patients: Renal chronic patients in hemodialysis treatment.~   "
245922|NCT00334464|"~     Anticoagulation with warfarin is a common and potentially hazardous therapeutic intervention.~     It is a leading cause of iatrogenic bleeding events and, hence, of malpractice claims. There~     are no good alternatives presently for warfarin anticoagulation, and even when alternatives~     become available (i.e., ximelagatran), cost, labeling, and experience (outcomes-related)~     issues will continue to favor an extensive and ongoing use of warfarin. If the present study~     is able to confirm an advantage for a genotype-driven algorithm, in terms of improved~     efficiency, therapeutic efficacy, and, especially, safety, then a pharmacogenetics approach~     to warfarin dosing can be recommended as the basis for an Intermountain Health Care~     (IHC)-wide quality improvement initiative that should improve patient outcomes, reduce~     resource use (costs of achieving safe and therapeutic anticoagulation), and reduce adverse~     clinical events. COUMA-GEN is a prospective, randomized study of patients who are to begin~     chronic warfarin therapy for specific, qualifying clinical reasons (i.e., atrial fibrillation~     (AF), deep vein thrombosis (DVT), or post-orthopedic surgery prophylaxis). Qualifying~     patients will be consented and randomized to an individualized, genotype-based~     warfarin-dosing regimen or to standard care (without knowledge of genotype). In each study~     arm, a predicted maintenance dose will be determined. All patients will receive a baseline~     International Normalized Ratio (INR). For patients in all 3 entry strata, a starting dose of~     warfarin that is twice the assigned daily maintenance dose (according to the specific~     treatment arm) will be prescribed on the first and second days, and then the dose will revert~     to the assigned maintenance dose.~   "
245923|NCT00334451|"~     The RAPID-RF Registry aims to characterize LATITUDE® Patient Management's alert feature:~     LATITUDE Active Monitoring™ by evaluating type and frequency of alert notifications and~     alert-related medical interventions. This registry will also assess clinical outcomes~     including quality of life and New York Heart Association Class changes over time, mortality,~     hospitalizations and heart failure-related event rates.~   "
245924|NCT00334438|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as rituximab, and radiolabeled monoclonal~     antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them without harming normal cells.~     Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more~     cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with~     relapsed or refractory low-grade, follicular, or mantle cell non-Hodgkin's lymphoma.~   "
245925|NCT00334425|"~     To evaluate the effect of LH-activity supplementation during the early follicular phase in~     GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by~     comparing different combinations with HP-HMG and r-FSH.~   "
245926|NCT00334412|"~     Combination therapy of caspofungin and amphotericin B could be a useful treatment option in~     invasive fungal disease, but before it can be routinely recommended; carefully controlled and~     well-designed randomized clinical trials are needed.~   "
245927|NCT00334399|"~     The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in~     patients with Type2 Diabetes Mellitus treated with Biguanide.~   "
245928|NCT00334386|"~     Primary objective:To demonstrate the no-inferiority in efficacy of treatment with~     Torsemide-PR in relation to Torsemide-IR in patients with mild and/or moderate hypertension.~      Secondary objectives: To evaluate the safety and tolerability of Torsemide-PR.~   "
245929|NCT00334373|"~     The purpose of this trial is to compare post-conditioning to standard angioplasty (50/50~     chance) in patients who present with an acute heart attack and are taken directly for an~     angioplasty procedure. Post conditioning is a procedure that involves balloon inflation~     followed by deflation in a series of cycles that appears to show (based on early data) that~     it can decrease the amount of damage to the heart muscle as compared to standard angioplasty~     procedures.~      Hypothesis: For Subjects undergoing direct PCI for STEMI, post conditioning with cycles of~     balloon inflation/deflation within the first minute following the re-establishment of~     coronary blood blow, will decrease the amount of irreversible myocardial damage assessed by~     delayed enhancement contrast CMR.~   "
245930|NCT00334360|"~     The purpose of this research is to determine if the combination of buspirone and~     dexmedetomidine are effective as a treatment to induce therapeutic hypothermia.~      The design of the study includes four study days done in random order. The days are as~     follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a~     computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the~     combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6~     ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic~     technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted~     into the other arm for drug administration.~      Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting~     the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air~     warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and~     lower-body will individually be maintained at the designated skin temperature. Lactated~     Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to~     decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen~     consumption or electromyographic intensity (see below) continues to increase or a total of 5~     liters of fluid is given. Heart rate will be measured continuously using an~     electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at~     the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of~     the baseline), the study will stop and the volunteer will be re-warmed immediately.~   "
245931|NCT00334347|"~     To compare the time to response, response rates, remission rates, and side effects in Bipolar~     Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.~   "
245932|NCT00334334|"~     Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of~     the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus~     influenzae type b.~   "
245933|NCT00334321|"~     This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in~     post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.~   "
245934|NCT00334308|"~     The Question posed is: Does an barley protein concentrate have health benefits similar to~     those demonstrated for soy protein foods which would justify the use of the non-fiber~     components of barley as functional food ingredients? Hypotheses: 1. Cholesterol Lowering:~     There is good evidence indicating that soy protein lowers serum cholesterol levels. The~     evidence was strong enough for a health claim for coronary heart disease risk reduction to be~     approved by the FDA. In addition, we have found that wheat gluten significantly reduced serum~     triglyceride levels. However, there is a need to assess the possible health benefits other~     vegetable protein sources. Barley is grown in relatively large amounts in Canada and barley~     protein would be a readily available vegetable protein source if health attributes could be~     ascribed to it. In addition other components of barley, including plant sterols and~     phenolics, may have hypocholesterolemic and antioxidant properties. 2. Antioxidant: In~     addition to cholesterol-lowering and possibly of equal importance in terms of prevention of~     cardiovascular and other chronic diseases, the barley phenolics associated with barley~     protein and may have added benefits as antioxidants. 3. Markers of Inflammation: Barley~     components are considered to be hypoallergenic. Hence their use in the cosmetic industry.~     Auto-immune and inflammatory responses are associated with increased CHD risk. Barley protein~     consumption may therefore reduce the levels of the pro-inflammatory cytokines; and the acute~     phase proteins. 4. Arterial Dilatation: Barley proteins may also have beneficial effects on~     vascular reactivity which may reduce CHD risk on account of their higher arginine:lysine~     ratio. Arginine enhances nitric oxide synthesis associated with endothelial relaxation and~     arterial dilatation. Barley may therefore increase pulmonary nitric oxide levels.~   "
245935|NCT00334295|"~     The purpose of this study is to determine the efficacy of a monthly administration of~     Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of~     the clinical tumour response after 3 injections.~   "
245936|NCT00334282|"~     To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally~     advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible~     patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib~     once daily or matching placebo. The study treatment will continue until patients experience~     disease progression, unacceptable toxicity or death. Primary objective of the study is to~     evaluate and compare the two treatment arms for progression-free survival. Principal~     secondary objective is to evaluate and compare the two treatment arms with respect to overall~     survival. Other objectives are overall response rate [complete response (CR) + partial~     response (PR)], rate of CR + PR + 6 months stable disease, and the incidence, severity and~     causality of adverse events and serious adverse events. Safety and efficacy assessments will~     be regularly performed on all patients. An Independent Data Monitoring Committee will be~     established to monitor safety during the course of the study and to evaluate interim efficacy~     data on overall survival.~   "
245937|NCT00334269|"~     The purpose of this study is to develop an effective intervention strategy to prevent &~     reduce obesity among a high risk cohort of Aboriginal families.~   "
245938|NCT00334256|"~     To study the pharmacokinetic properties, safety and viral resistance pattern of the~     combination of tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant~     women and their newborns, with a view to prevention of mother-to-child transmission (PMTCT)~     of HIV-1 in Africa and Asia.~   "
245939|NCT00334243|"~     Many infertile patients have a decreased chance of becoming pregnant when using in vitro~     fertilization (IVF). For these patients, many different treatments are available, but none of~     them have been shown to be better than the others. We are testing which of three different~     treatments are better than the others. Patients who are expected to have a decreased response~     to ovarian stimulation will be randomized to either a microflare protocol, an antagonist~     protocol, or a demi-halt protocol.~   "
245940|NCT00334230|"~     This study, conducted in collaboration with the National Rehabilitation Hospital (NRH) in~     Washington, D.C., will look at changes in brain activation and brain responses that occur~     with gait (walking) training. Brain images and responses of healthy subjects are compared~     with those of patients.~      Healthy normal volunteers and people who have had a stroke within 3 months of starting the~     study may be eligible for this study. Candidates must be between 18 and 80 years of age, and~     patients must participate in NRH's walking study.~      Stroke patients participate in all three study sessions described below. The first session~     takes place before patients start the NRH walking training study, the second session takes~     place at completion of the NRH walking study, and the third session takes place 3 months~     after completing the NRH study. Healthy control subjects complete only the procedures in~     session 3.~      Session 1~      Day 1: Neurological examination and questionnaire to evaluate memory and attention.~      Day 2: Motor testing with transcranial magnetic stimulation (TMS). For this test, a wire coil~     is held on the subject's scalp. A brief electrical current passes through the coil, creating~     a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked~     to tense certain muscles slightly or perform other simple actions to help position the coil~     properly. The stimulation may cause a twitch in the leg muscles, and the subject may hear a~     click and feel a pulling sensation on the skin under the coil.~      Session 2~      Day 1: Functional MRI (fMRI). MRI uses a magnetic field and radio waves to produce images of~     body tissues and organs. The subject lies on a table that can slide in and out of the scanner~     (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur~     during the scanning process. Scanning time varies from 20 minutes to 3 hours, with most scans~     lasting 45 and 90 minutes. Subjects may be asked to lie still for up to a few minutes at a~     time and to perform movements of their foot.~      Day 2: motor testing with TMS.~      Session 3~      Day 1: fMRI~      Day 2: motor testing with TMS~   "
245941|NCT00334217|"~     This study is for the purpose of determining whether cognitive remediation may improve~     cognition and treatment response in patients entering substance abuse day treatment~   "
245942|NCT00334204|"~     The kidneys are highly vascular organs and any trauma or surgery poses risk of severe~     bleeding. Platelet function is an integral part of the blood clotting during the initial,~     so-called vascular phase. So far no universally accepted, easy test has been available to~     measure platelet functions. Renal failure is a condition generally associated with bleeding~     due to platelet dysfunctions. This study is exploring the utility of a novel platelet~     function test, called Platelet Function Analyser-100 to predict bleed after percutaneous~     kidney biopsy. Platelet Function Analyser-100 will be measure before kidney biopsy along with~     routine blood tests. Subjects will undergo renal ultrasound before and after renal biopsy to~     verify post-biopsy bleeding events.~   "
245943|NCT00334191|"~     Many patients develop kidney failure after cardiac surgery. Although this kidney failure can~     usually be treated effectively, a longer stay in intensive care is often required. While many~     patients suffer no long term ill effects after developing post-operative kidney failure, some~     require long term kidney dialysis. We also know that patients who develop post-operative~     kidney failure are much more likely to die before they leave hospital.~      Why some people develop kidney failure after cardiac surgery is not known. However, doctors~     suspect that the process of cardiopulmonary bypass (where the functions of the heart and~     lungs are taken over by a machine during the operation, to allow the surgeon to operate)~     overactivates some of the same mechanisms the body uses to defend itself against severe~     infection.~      Many of the cell changes by which severe infection causes kidney failure also occur after~     cardiopulmonary bypass. One of the main overactive defence mechanisms is the release of~     highly toxic compounds derived from oxygen - a process called 'oxidative stress'.~      The investigators believe that sodium bicarbonate might reduce the oxidative stress, which~     occurs during cardiac surgery, and so prevent or decrease the kidney failure, which occurs in~     many patients.~      The investigators hope to give sodium bicarbonate (in similar doses to those used safely for~     treatment of acidosis) to patients during, and for 24 hours after cardiac surgery, and to~     compare the effects with patients who have not had sodium bicarbonate. The drug, or a~     placebo, will be given through the drip, which is present in all cardiac surgery patients.~     Whether a particular patient receives the drug or placebo will be decided at random, and~     neither the patient nor the investigators will know which has been given. We will measure~     kidney function before and after the operation using the standard blood tests.~      The investigators will also take four 20ml samples of blood, spaced before, during, and after~     the operation, from the arterial catheter routinely inserted in every patient. This blood~     would be used to measure oxidative stress, and also some of the proteins inside the blood~     cells, which are responsible for creating the toxic oxygen compounds. In this way we will~     discover not only the effect of sodium bicarbonate, but also the mechanism of that effect.~      Sodium bicarbonate is commonly used to treat metabolic acidosis in severe renal disease,~     circulatory insufficiency due to shock or severe dehydration and has been shown to be an~     effective drug in preventing contrast-induced nephropathy.~      Sodium bicarbonate is considered to be safe in the setting of intensive care treatment and is~     often used in the treatment of patients with metabolic acidosis without any discernible~     adverse clinical effects.~      This is a pilot study. If the drug proves effective in this context, further studies on a~     larger scale would be required to justify its general use.~      There will be no extra risk to a patient who participates in the study, and no discomfort~     other than that normally associated with cardiac surgery.~      Informed consent will be obtained from the patient prior to the operation by one of the~     investigators or the ICU research nurse. The clinical care of a patient who does not consent~     for any reason will not be affected.~   "
245944|NCT00334178|"~     The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with~     placebo in prophylactic monotherapy treatment of migraine headache.~   "
245945|NCT00334165|"~     The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in~     relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty~   "
245946|NCT00334152|"~     This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will~     significantly decrease the number of patients who experience nausea and vomiting after~     surgery.~   "
245947|NCT00334139|"~     Bisphosphonates have been used extensively in the treatment and the prevention of skeletal~     complications associated with bone metastases in patients with breast cancer and prostate~     cancer.~      The purpose of this study is to assess the effect of zoledronic acid patients with prostate~     cancer or breast cancer and bone metastasis.~   "
245949|NCT00334113|"~     The overarching objective of this study is to develop an innovative strategy to address the~     problems of obesity and diabetes by promoting exercise adoption. An automated telephone~     intervention will be developed that can be used to enhance exercise adoption over a twelve~     month period in a population of overweight or obese veterans with Type 2 diabetes.~   "
245950|NCT00334100|"~     The purpose of the study is to determine whether treadmill training is safe and beneficial in~     patients with walking difficulty because of multiple sclerosis.~   "
245951|NCT00334087|"~     -  200 children between ages 36 to 48 months will be invited for a regular dental~          examination~        -  Parameters to be investigated~             1. Pregnancy history~             2. Birth outcome~             3. Child's general health~             4. Feeding habits~             5. Oral hygiene habits~             6. Dmft caries index~             7. Congenital enamel defects~   "
245952|NCT00334074|"~     The purpose of this trial is to to determine the safety and effectiveness of therapeutic~     combination - Clofarabine and Cytarabine for the treatment of AML and MDS.~   "
245953|NCT00334061|"~     This clinical evaluation is a prospective, single-arm, multi-center trial.~      The purpose of this clinical evaluation is to assess the safety and effectiveness of the~     Penumbra System in the revascularization of patients presenting with acute ischemic stroke~     secondary to intracranial, large vessel, occlusive disease.~   "
245954|NCT00334048|"~     Antidepressant medicines sometimes cause sexual side effects. The purpose of this study is to~     determine whether the sexual dysfunction sometimes caused by selective serotonin reuptake~     inhibitor (SSRI) antidepressant medications can be reversed by treatment with Requip~     (ropinirole), a medicine which is used to treat Parkinson's Disease and restless leg~     syndrome.~   "
245955|NCT00334035|"~     For schizophrenic patients who remained in remission while on maintenance medication, there~     may come a point in time when the relative risk for relapse become so low that~     discontinuation of therapy can be considered. This study is to investigate whether that point~     in time is reached in 12 months following the first episode illness. Moreover, it also aims~     to identify other predictors of relapse as well as to evaluate the costs and benefits of~     maintenance therapy.~   "
245956|NCT00334022|"~     In order to better understand the source(s) and the mechanism(s) of HIV persistence and to~     potentially lead to further suppression of HIV from viral reservoirs, we propose to examine~     the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of~     the size of the viral reservoir in infected individuals who are receiving effective antiviral~     therapy for extended periods of time (> 5 years).~   "
245957|NCT00334009|"~     Although clinical risk factors for postoperative development of vasodilatory shock and acute~     renal failure have been identified; there is a considerable proportion of patients undergoing~     cardiac surgery where this syndrome cannot be predicted.~      We sought to investigate the impact of Catecholamine-O-Methyltransferase (COMT) polymorphism~     on the duration of vasodilatory shock and other important clinical outcomes in cardiac~     surgery patients.~      COMT is a key enzyme in the degradation of catechols eg. catecholamines. 25% of the~     population have a low activity (L/L) of this enzyme. Sustained low COMT activity is~     associated with an altered metabolic profile of catecholamines and their degradation~     products.~      The process of cardiopulmonary bypass (CPB)over-activates some of the same mechanisms the~     body uses to defend itself against severe infection. One of the main overactive defence~     mechanisms is the release of highly toxic compounds derived from oxygen - a process called~     'oxidative-stress'. Increased reactive oxygen species (ROS) generation can lead to~     inactivation of biologic mediators, including catecholamines. It is well established that~     some radicals autoxidizes catecholamines, including DA, NE, and epinephrine and contribute~     significantly to vasoplegia.~      As part of this study, we will take six 2.7mL samples of blood, collected before, and after~     the operation, from the arterial catheter routinely inserted in every patient. This blood~     will be used to measure COMT genotype, the concentration of plasma-catecholamines as well as~     marker of oxidative stress.~      Our plan is to enrol patients undergoing cardiac surgery if the use of the CPB is planned.~   "
245958|NCT00333996|"~     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone~     for the treatment of non-infectious anterior uveitis.~   "
245959|NCT00333983|"~     The purpose of this study is to compare 2 training programs using robotic exercise devices to~     supervised arm exercises in stroke patients with chronic stable deficits.~   "
245960|NCT00333970|"~     The purpose of this study is to determine which variables predict improvement on a cognitive~     training task battery, used for patients with schizophrenia, and to determine the proportion~     of patients whose performance returns to normal following cognitive training~   "
245961|NCT00333957|"~     Cystic Fibrosis patients continue to have bowel problems even after adequate pancreatic~     enzyme supplementation. There may be pathology of the lining of the bowel. Capsule endoscopy~     will be used to photograph the entire bowel.~   "
245962|NCT00333944|"~     The purpose of this study is to determine whether high doses of pralidoxime(PAM) are~     effective as compare to lower doses of PAM in the management of moderately sever~     organophosphorus poisoning patients.~   "
245963|NCT00333931|"~     The purpose of this study is to identify changes in brain functioning which are related to~     reduced frequency and/or intensity of impulsive aggressive actions after treatment of~     PTSD-related impulsive aggression with either phenytoin or cognitive behavioral therapy.~   "
245964|NCT00333918|"~     The primary objective of this study is to investigate the efficacy and safety of bromfenac~     ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo~     cataract extraction and intraocular lens implantation.~   "
245965|NCT00333905|"~     The purpose of this study is to determine if reducing blood flow to an exercising muscle~     during exercise training will enhance the training effect on that muscle in people who have~     limited exercise because of congestive heart failure~   "
245966|NCT00333892|"~     To further investigate differences in the immunologic function of various lymphocyte subsets~     in HIV-infected patients who are treated early in their infection and during the chronic~     phase of the infection. Studies will also be done to further delineate the various~     antigen-specific and innate immune responses including characterization of soluble factors~     associated with primary HIV infection.~   "
246956|NCT00320541|"~     This study will compare the cancer response to both treatments for locally advanced or~     metastatic breast cancer~   "
245969|NCT00333853|"~     Insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing.~     Effective presentation and data analysis are essential. We examined HbA1c changes using the~     OneTouch(R) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic~     logbook, compared to established meters with paper logbooks (Control Group).~   "
245970|NCT00333840|"~     The purpose of this study is to evaluate and compare the side effects and anti-leukemic~     benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid~     leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to~     receive either interferon plus Ara-C or imatinib as initial treatment.~   "
245971|NCT00333827|"~     The purpose of this study is to determine effect of cell therapy in patients with severe~     dilated cardiomyopathy~   "
245972|NCT00333814|"~     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone~     for the treatment of non-infectious intermediate or posterior uveitis.~   "
245973|NCT00333801|"~     To study the impact of Individual Placement and Support (IPS) supported employment (SE)~     compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with~     posttraumatic stress disorder (PTSD).~   "
245974|NCT00333788|"~     The study will continue to assess the safety of certolizumab pegol (CDP870) as well as~     examine the evolution of long term efficacy in Crohn's disease patients who completed study~     C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct~     cost parameters.~   "
245975|NCT00333775|"~     This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with~     docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast~     cancer who are candidates for taxane-based chemotherapy but who have not received prior~     chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the~     target sample size is 500+ individuals.~   "
245976|NCT00333762|"~     The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for~     power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in~     realistic indoor environments with target users performing realistic tasks. We will combine~     group trials involving individuals who have a visual impairment (but do not have a mobility~     impairment) with several single-case studio involving individuals who have a visual and~     mobility impairment. Our long-term objective is to provide independent mobility to veterans~     with mobility and sensory impairments.~   "
245977|NCT00333749|"~     Children with acute diseases with oral ulcers (not included PRESENTATIONS OF SLE, IBD or~     IMMUNOCOMPRMIZED STATES)will receive several doses (drinking or mouth rinsing) of either~     pasteurized goat milk or cow milk. Children will than be followed for length of the disease -~     signs and symptoms.~   "
245978|NCT00333736|"~     Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life,~     greater satisfaction, and fewer adverse events compared with using the standard needle.~   "
245979|NCT00333723|"~     This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg~     once daily) in African American and Hispanic patients with type 2 diabetes mellitus. As~     microvascular and macrovascular disease are significant contributors to diabetes morbidity~     and mortality and previous studies suggest that the thiazolidinedione compounds could have~     potentially beneficial vascular effects, the effects of rosiglitazone therapy on serum~     parameters associated with endothelial dysfunction, vascular inflammation and impaired~     fibrinolysis were examined in this study. Improvement in these parameters suggests that~     rosiglitazone may provide an additional beneficial vascular effect, apart from its ability to~     improve glycemic control.~   "
245980|NCT00333710|"~     The main objective of this proposal is to develop and test the efficacy of two interventions~     (a telehealth and face-to-face intervention) designed to improve quality of life, self-care,~     motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV~     and PTSD. It is hypothesized that~   "
245981|NCT00333697|"~     To determine the rate of thromboembolic complications (including death attributed to~     thromboembolic disease) in patients with a score rated as DVT likely on a formalized~     scoring system, when anticoagulation therapy is withheld on the basis of a negative~     comprehensive duplex ultrasound examination. Participants are followed for three months after~     a normal ultrasound to determine if any symptoms attributable to deep vein thrombosis~     develop. Any such symptoms are verified by objective tests.~   "
245982|NCT00333684|"~     Evaluate and record any changes in the Quality of Life and psychological state of the~     affected study group following treatment with Bio-Alcamid.~      Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and~     contours of the face affected by HIV drug-induced lipoatrophy. Pre-treatment classification~     and post treatment recording of changes will be performed by, both, the Principal~     Investigator and the Treatment Specialist and independently by a 'Blinded' Co-Investigator at~     post treatment Week 12.~      Safety data for Bio-Alcamid will be collected throughout the duration of the study. Safety~     will be determined by the rates of procedure-related events and adverse experiences~     associated with the use of Bio-Alcamid.~   "
245995|NCT00333515|"~     The purpose of this placebo-controlled study is to evaluate the safety, tolerability and~     pharmacokinetics of a single dose regimen of human butyrylcholinesterase (HuBChE) in healthy~     adults at 3 ascending dosage levels administered IV. HuBChE, which occurs naturally in human~     plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical~     nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers in~     each dosage cohort will be randomized to treatment with HuBChE active drug or normal saline~     placebo in a 3:1 ratio. The volunteers will remain in the study for 90 (+/- 7) days. For the~     first 3 days following dose administration, they will remain at the clinical trial site as~     inpatients and will be closely monitored for patient safety. Afterwards, they will return to~     the trial site (at pre-determined intervals) as outpatients for 8 further visits, where~     patient safety will be assessed.~   "
245996|NCT00333502|"~     CRLX101 is a nanopharmaceutical comprised of the chemotherapeutic camptothecin (CPT)~     conjugated to a linear, cyclodextrin-based polymer. CRLX101 is designed to increase the~     exposure of tumor cells to CPT while minimizing side effects.~      OBJECTIVES:~      • Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CRLX101 when~     administered intravenously to subjects with advanced solid tumors.~   "
245983|NCT00333671|"~     Diabetic macular oedema is characterized by fluid accumulation in the retinal tissue from~     leaking retinal vessels, the capillaries. This state can lead to severe visual loss and~     blindness. According to basic physiologic rules several factors influence the fluid transport~     between the capillaries and the surrounding tissue. One of these factors is the balance~     between the large molecules within the vessel lumen and the retinal tissue. Some drugs change~     this balance, the osmotic balance, by moving the fluid from the tissue to the vessel lumen.~     In relation to diabetic macular oedema, treatment with such a drug potentially would reduce~     the retinal thickness because it extracts fluid from the retinal tissue. Glycerol has this~     potential. If reduction of the thickness with glycerol is confirmed, then it proves the~     significance of the osmotic balance in the basic nature of diabetic macular oedema.~      In this study we therefore examine the time dependent change in retinal thickness after~     glycerol intake by an instrument called optical coherence tomography (OCT). The participants~     drink glycerol and the thickness of the retina is then monitored closely by OCT during the~     following three hours. Since diabetic changes in the retina are focal pr. definition, the~     secondary purpose of the study is to find any regional differences in the response. The~     examinations are repeated at a second visit where the patient drink another dose of glycerol,~     because we also want to analyse for a dose dependent response. Which dose is given at each~     visit is randomised on beforehand. In addition to measuring the retinal thickness a variety~     of examinations are performed both before and during the study, e.g. blood samples and~     systemic blood pressure measurements.~   "
245984|NCT00333658|"~     This research has been designed to learn whether getting regular and specific feedback about~     work performance with small rewards for meeting goals helps people to improve their job~     performance and leads to better work outcomes, improved mental functioning, and better~     quality of life~   "
245985|NCT00333645|"~     This is a non-comparative, open, multisite prospective estimation study to evaluate the~     efficacy and safety of caspofungin in the prophylactic treatment of adults who have received~     an orthotopic liver transplant and are at high risk of developing an invasive fungal~     infection. It is expected that the proportion of high-risk liver transplant recipients who~     develop a documented (proven or probable per European Organization for Research and Treatment~     of Cancer/Mycoses Study Group [EORTC/MSG] modified criteria) invasive fungal infection during~     the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15%. It~     is also expected that the incidence of serious drug-related adverse events will be less than~     25%.~   "
245986|NCT00333632|"~     The purpose of this study is to determine whether an intravenous infusion of dexmedetomidine~     administered to surgical patients intra-operatively will improve the characteristics of sleep~     post-operatively.~   "
245987|NCT00333619|"~     This project is a randomized controlled trial to test whether a multicomponent,~     nonpharmacological intervention improves sleep/wake patterns and functional recovery among~     older people undergoing post-acute rehabilitation.~   "
245988|NCT00333606|"~     To investigate whether body acupuncture of acupuncture points specific for hearing influences~     the auditory avoked potentials in comparison to puncture of non-specific acupuncture points~   "
245989|NCT00333593|"~     Patients within the intensive care unit who have severe infections causing shock and kidney~     failure have almost a 60% risk of dying despite antibiotic therapy, surgical drainage of the~     site of infection and intensive care support with fluids, nutrition, mechanical ventilation~     and continuous artificial kidney support. This persistently high death rate continues to~     stimulate the development of new approaches to the treatment of septic shock.~      Much clinical and molecular biology research suggests that these patients die because of an~     uncontrolled immune system’s response to infection. This response involves the production of~     several substances (so called “humoral mediators”), which enter the blood stream and affect~     the patient's organs ability to function and the patient's ability to kill germs. These~     substances may potentially be removed by new artificial filters similar to those currently~     used during continuous hemofiltration (the type of artificial kidney support used in~     intensive care).~      Recent investigations by ourselves and others, however, have made the following findings:~        1. Standard filters currently used in intensive care are ineffective in removing large~          amounts of these “humoral mediators” because the holes in the filter are too small to~          allow all of them to pass through~        2. The standard filters currently used in intensive care are also ineffective in removing~          large amounts of these “humoral mediators” because the standard filtration flow through~          the membrane is less than 100 ml/min~        3. When the filtration flow through the membrane is increased to above 100ml/min, patients~          require a lesser dose of drugs to support their blood pressure which is an indirect sign~          that the filters are clearing some of the humoral mediators~        4. Even when the blood flow through standard filters is increased to above 100ml/min, there~          is still not optimal clearing of humoral mediators It is possible, however, that,~          using a different filter membrane with bigger holes in it, would make it easier to clear~          the blood of these humoral mediators. It is thought that this would be noticeable~          clinically in the amount of drugs required to support blood pressure.~      A filter that has these bigger holes is now available. It is made of the same material as the~     standard filters that are currently used in the intensive care unit, only the holes have been~     made bigger to allow these humoral mediators to be removed from the blood. This polyamide~     filter is made of synthetic semipermeable material. This material is highly compatible with~     human blood. This modified polyamide filter is made of exactly the same compatible material~     but the holes in the material are slightly larger through a minor modification of the~     manufacturing process.~      This larger hole filter has now been used in preliminary studies in humans and has been found~     to reduce the blood levels of some humoral mediators. Laboratory studies conducted by~     ourselves showed that this new filter can achieve the highest reported clearance of some of~     the humoral mediators with minimal effect on useful proteins in blood such as albumin~     during hemodialysis. This loss is very small and unlikely to contribute to any detectable~     clinical changes.~      We, therefore, now propose to study the effect of using new large hole filters with~     hemodialysis in patients with severe infections and acute kidney failure.~      We wish to compare the effect of this new therapy to that of standard filters. The new~     therapy will be considered to be effective if it lowers the amount of drugs used to support~     blood pressure and if it lowers the blood levels of some humoral mediators more than~     standard therapy. We will also monitor blood levels of important components of blood such as~     albumin and electrolytes in each group.~      This is a pilot study involving only 10 patients who will each receive 4 hours of the~     standard therapy and 4 hours of the new therapy. Which treatment the patient receives first~     will be random (like the tossing of a coin). Blood samples will be taken at the start and~     after 4 hours of each treatment. The waste product of dialysis called spent dialysate will~     also be collected for the measurement of humoral mediators at the start and after 4 hours of~     each treatment. The changes in blood pressure and drugs used to support it will be recorded~     hourly. As patients involved in the study would normally receive hemofiltration because of~     their kidney failure, all the risks and benefits associated with the procedure would be~     unchanged. The only risk to patients would come from exposure to a modified membrane and from~     having two additional spoonfuls of blood taken.~      If this new membrane were found to have a major effect on the blood level of humoral~     mediators and on the patients’ blood pressure, further studies would then be justified to~     assess its clinical effects (time in ICU, time in hospital, time on ventilator, duration of~     organ failure, etc).~   "
245990|NCT00333580|"~     The purpose of this study is to modify and develop measures that reflect outcomes that are~     relevant to recovering Veterans and are sensitive to improvements resulting from innovative~     gait interventions.~   "
245991|NCT00333567|"~     This study is designed to investigate the efficacy and safety of a single daily dose of 400~     mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing~     pain associated with ambulatory arthroscopic knee surgery~   "
245992|NCT00333554|"~     Type 1 Diabetes (T1D) is an autoimmune disease. This means that the immune system (the part~     of the body which helps fight infections) mistakenly attacks and destroys the cells that~     produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's~     ability to produce insulin decreases.~      The autoimmune process is thought to be initiated by a gene-environment interaction. The~     genetics involved in the development of T1D are fairly well understood. There is a higher~     risk of developing T1D with the presence of the human leukocyte antigen (HLA) DR3 or DR4. It~     is also known that not everyone with these genes actually develops T1D. Therefore, one or~     more environmental factors are thought to contribute to the process of developing T1D.~      The consumption of the anti-inflammatory fatty acids, the omega-3 fatty acids, has decreased~     significantly in the past 100 years. At the same time a rise in the incidence of T1D,~     especially in young children has occurred. Because of the warnings to eliminate fish during~     pregnancy, pregnant women are consuming even less omega-3 fatty acids during fetal~     development.~      Observations have been made that children who have received omega-3 fatty acid~     supplementation have a lower risk of T1D. Omega-3 fatty acids could have a protective effect~     that may occur during pregnancy, infancy, or both. The mechanism of this protection may be~     due to the DHA mediated suppression of the inflammatory response.~      Patients at higher risk for T1D have an increased pro-inflammatory environment. We~     hypothesize that DHA supplementation during pregnancy and early childhood will block the~     initial pro-inflammatory events and prevent development of islet cell autoimmunity in~     children at higher risk for T1D.~      This study is a feasibility study to determine if a full-scale DHA supplementation study will~     be implemented. If a full study is implemented, the primary outcome will be to determine if~     nutritional supplementation with omega-3 fatty acids during the last trimester of a mother's~     pregnancy and/or the first three years of life for children who are at higher risk of T1D~     will prevent the development of islet autoimmunity.~   "
245993|NCT00333541|"~     This purpose of this study is determine whether the use of internet technology to communicate~     with adolescents about contraception is feasible and to determine whether it is more~     effective than traditional methods. Study subjects will complete baseline and follow-up~     surveys at 3, 6, and 12 months about their contraceptive practice and sexual behaviors.~      Subjects with internet access will be randomized to either completing surveys remotely over~     the internet through email or to follow-up in clinic on laptop computers.~      Our hypothesis is that women who have access to the internet as well as use the internet~     regularly are more likely to complete follow-up surveys. This will then in turn allow us to~     get a better understanding of contraceptive practices amongst high risk teens.~   "
245994|NCT00333528|"~     The purpose of this placebo-controlled study is to evaluate the safety, tolerability and~     pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy~     adults. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis~     and treatment in the event of exposure to chemical nerve agents (as employed during chemical~     warfare or as an act of terrorism). Volunteers will receive a single intramuscular infusion~     of either HuBChE or normal saline placebo. The volunteers will remain in the study for 90~     (+/- 7) days. For the first 3 days following dose administration, they will remain at the~     clinical trial site as an inpatient and will be closely monitored for patient safety.~     Afterwards, they will return to the trial site (at pre-determined intervals) as an outpatient~     for a further 8 visits, where patient safety will be assessed.~   "
245997|NCT00333489|"~     The objective of this study is to evaluate efficacy, safety and tolerability of the~     valsartan+amlodipine association in patients with mild to moderate essential hypertension, in~     comparison to amlodipine alone.~      Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO~     classification (8)]. The diastolic blood pressure threshold for inclusion in this study is 95~     mmHg, as these patients are more likely to benefit from association therapy than patients~     with lower diastolic blood pressure.~      For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will~     not be included in this study. Moreover, patients developing severe hypertension (MSDBP > 110~     mmHg and/or MSSBP > 180 mmHg) during the open-label treatment phase will be discontinued from~     the study.~   "
245998|NCT00333476|"~     Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that~     causes a progressive loss of central vision. AMD is the leading cause of legal blindness~     among adults age 50 or older in the Western world. AMD presents in two different types -~     dry and the more severe wet form. Wet AMD is caused by the growth of abnormal blood~     vessels in the macula. Squalamine lactate is an investigational drug that may prevent the~     growth of these abnormal blood vessels. This study will test the safety and efficacy of~     Squalamine in the treatment of AMD.~   "
245999|NCT00333463|"~     A study to examine patient compliance with once daily glaucoma medication~   "
246000|NCT00333450|"~     To evaluate the immunological memory against pneumococcal vaccine serotypes in children~     primed with conjugate vaccines by administering a booster dose of plain polysaccharide~     vaccine.~   "
246001|NCT00333437|"~     Researchers from the Division of Pulmonary and Critical Care Medicine at University of~     California, San Francisco (UCSF) are conducting a study to evaluate whether mycophenolate~     mofetil (an immunosuppressive medication, trade named CellCept) is safe and effective for~     preventing the lung damage from scleroderma from getting worse.~   "
246002|NCT00333424|"~     The development of a safe and effective vaccine for HIV is the subject of intensive~     world-wide research. Various approaches are being investigated in monkey models and humans.~     This is a randomized, double-blind trial to evaluate the safety and immunogenicity of a~     candidate preventative human immunodeficiency virus (HIV) vaccine strategy in 24 healthy~     adult Thai volunteers with no identifiable risk behaviour for HIV-1 infection. Volunteers~     will receive three priming vaccinations at weeks 0, 4 and 8 (pHIS-HIV-AE, a DNA vector~     delivering AE clade HIV-1 genes). This will be followed at week 12 by single boost~     vaccination (rFPV-HIV-AE, non-replicating, recombinant fowlpox virus vector delivering the~     same HIV-1 genes). Safety and immunological monitoring will continue to 52 weeks~   "
246003|NCT00333411|"~     The purpose of this clinical study is to determine the effectiveness, pharmacokinetics and~     safety of several doses of BIRT 2584 XX (100mg, 300mg and 500mg) taken once daily in the~     treatment of moderate to severe plaque-type psoriasis. This new medicine will be compared to~     a so-called placebo medicine over 12 weeks with a 12 weeks treatment extension possible.~   "
246004|NCT00333398|"~     The purpose of this study is to investigate the effectiveness, safety, and tolerability of an~     influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world~     in the winter months. Infection with an influenza virus is a major public health threat as it~     has the ability to spread rapidly and affect large numbers of people. Up to 1359 healthy~     adults ages 18 to less than 65 years old will participate in this study for up to 24 days.~     Volunteers will receive an injection of either influenza vaccine with thimerosal, vaccine~     without thimerosal, or placebo with thimerosal. Volunteers will be asked to document~     information about any health changes for 21 days following vaccination. Volunteers will~     return to the clinic on days 5 and 21 after vaccination to share this information with study~     staff. On day 21, volunteers will have a physical examination. Blood samples will be taken~     prior to vaccination and at Day 21 post-vaccination.~   "
246005|NCT00333385|"~     The aim of this trial was to compare the safety and efficacy of courses of tobramycin and~     ceftazidime, administered intravenously as either thrice daily short infusions or 24 h~     continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary~     PA infection. In conventional treatment regimens, ceftazidime is administered in the form of~     thrice daily short infusions, but pharmacodynamic considerations suggest that continuous~     infusion could be more effective.~   "
246006|NCT00333372|"~     To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the~     assessment of subjective symptoms in order to further determine the optimal dosage and~     efficacy parameters for PhaseIII clinical trials.~   "
246007|NCT00333359|"~     The primary objective of this trial is to assess the long-term safety and efficacy of XP13512~     (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless~     Legs Syndrome (RLS).~   "
246008|NCT00333346|"~     The aim of this study is to compare the administration of 1 unit dose of 100 mg tramadol~     intravenously versus multiple smaller dosages of tramadol during the first 6 hours~     post-operatively and to investigate the time course and accuracy of pain relief versus the~     onset and duration of side-effects.~   "
246009|NCT00333333|"~     This research project is studying the causes for low platelet levels in preterm infants.~     Platelets are a component of blood that helps with clotting. The purpose of this study is to~     determine whether the cause for low platelet levels is the same in infants who are born to~     mothers with preeclampsia and infants who are small for gestational age.~   "
246010|NCT00333320|"~     The purpose of this study is to determine whether brief periods of ischemia performed just at~     the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and~     infarct size in humans~   "
246011|NCT00333307|"~     The purpose of this study is to determine whether different doses of recombinant human~     relaxin is safe when given to women with severe preeclampsia~   "
246012|NCT00333294|"~     The objective of this study is to determine wether the ZD1839 associated with a radiotherapy,~     before the beginning of chemotherapy is effective in the treatment of your disease and to~     evaluate the tolerance of these treatments.~   "
246013|NCT00333281|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the~     effects on vision of six months of daily dosing of 5 mg tadalafil or 50 mg sildenafil~     compared with placebo.~   "
246016|NCT00333242|"~     In the proposed study, we will build upon our previous studies validating and characterizing~     hyperalgesia in MM samples to explore it's underlying mechanism from a pharmacological~     perspective. Utilizing a double-blind, placebo-controlled designs, the proposed work will~     evaluate the ability of dextromethorphan , an N-methyl-D-aspartate (NMDA)-antagonists to~     diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by~     MM patients. Specifically, in a sample of MM patients, dextromethorphan, theorized to~     interfere with the development of opioid-induced hyperalgesia will be evaluated for its~     ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as~     reflected by changes on pain threshold and tolerance to both cold-pressor and electrical~     pain, at peak and trough methadone blood levels. The results of this work will not only~     provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this~     at-risk population, but also direction for the medical management of pain complicated by~     opioid-induced hyperalgesia.~   "
246017|NCT00333229|"~     Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may~     be associated with bone loss and the risk of breast cancer because of its potent effects on~     the mitotic activity of breast epithelium and on bone turnover.~      This study is will assess the safety and efficacy of Zoledronic acid 4 mg, given every 3~     months over 24 months, in improving bone mineral density in premenopausal women with hormone~     receptor negative breast cancer and adjuvant chemotherapeutic treatment compared to placebo.~      This study is not recruiting patients in the United States.~   "
246018|NCT00333216|"~     The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15~     mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry)~     age-related macular degeneration in patients who are at risk for progressing to exudative~     (wet) age-related macular degeneration.~   "
246019|NCT00333203|"~     The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating~     Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular~     membrane and vitrectomy.~   "
246020|NCT00333190|"~     The purpose of this trial is to determine if selectively removing only a small subset of T~     cells, called CD8+ T cells, is safe and if it can reduce the risk of graft versus host~     disease (GVHD) without losing the anti-cancer effects.~   "
246021|NCT00333177|"~     This study will determine the effectiveness of various combinations of psychosocial therapy~     and risperidone treatment in improving work or school performance in people with~     first-episode schizophrenia.~   "
246022|NCT00333164|"~     Multi-center, open-labelled randomized controlled trial, to study the effect of aspirin plus~     cilostazol and aspirin alone on the progression of intracranial arterial stenosis, in 200~     chronic stroke patients with 50-99% stenosis, to be followed up for 2 years~   "
246023|NCT00333151|"~     This trial is conducted in the United States of America (USA) and Canada. This trial is~     designed to show the effect of treatment with liraglutide when added to existing~     rosiglitazone and metformin combination therapy and to compare it with the effects of therapy~     with rosiglitazone and metformin alone.~   "
246024|NCT00333138|"~     This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720~     in patients with relapsing multiple sclerosis.~   "
246025|NCT00333125|"~     The purpose of this study is to compare the intraocular pressure (IOP)-lowering efficacy and~     safety of two combination products in patients with open-angle glaucoma or ocular~     hypertension.~   "
246026|NCT00333112|"~     A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of~     residual OAB symptoms in men.~   "
246027|NCT00333099|"~     The aim of this study is to investigate if enteral immunonutrition of head and neck or~     esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet~     [Impact (R), Novartis] versus a standard enteral nutrition (control, Novartis), could improve~     clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status,~     and life quality parameters.~   "
246028|NCT00333086|"~     Currently available treatments for endometrial cancer are associated with limited efficacy~     and significant toxicity. This study will assess the safety and efficacy of letrozole, an~     aromatase inhibitor, on endometrial cancer.~   "
246029|NCT00333073|"~     To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed~     (stress and urge) urinary incontinence after 12 months follow up period~   "
246030|NCT00333060|"~     The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic~     solution and drug-free solution to safely and effectively prevent or delay the progression of~     nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina~     repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies~     involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the~     lens.~   "
246031|NCT00333047|"~     Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging~     survival and improving the quality of life. The objective of this trial is to assess if an~     initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval~     as compared to chemotherapy alone.~   "
246032|NCT00333034|"~     The primary objective is to assess the efficacy and safety of etanercept 50 mg administered~     once weekly in subjects with psoriasis over 12 weeks.~   "
246033|NCT00333021|"~     This study is phase 3 study for prevention of VTE in patients with abdominal surgery.~   "
246034|NCT00333008|"~     The purpose of this study is to evaluate the feasibility and tolerability of delivering a~     full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine,~     prednisone, and rituximab) in NHL.~   "
246035|NCT00332995|"~     This Phase I trial will assess the feasibility of using a vaginal ring to deliver the~     candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13~     healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical~     and laboratory assessments. Feasibility of drug delivery will be assessed by measuring~     dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue,~     and plasma.~   "
246090|NCT00332215|"~     The primary objective of this study is to assess the safety of inhaled sodium pyruvate in~     people with Cystic Fibrosis (CF). Further, to determine whether inhaled sodium pyruvate will~     improve lung function, as determined by FEV1, or reduce inflammatory markers in induced~     sputum of people with CF.~   "
246036|NCT00332982|"~     The pragmatic issue at hand how to get physicians and nurses to use best practices… and how~     to measure consequences of their implementation. This is the science of knowledge~     translation, which we are realizing is an organic entity. As part of our Critical Care~     Strategy our goal is to improve the quality and continuity of critical care within our health~     care system. Toward this goal we are implementing a program which links 16 Ontario hospitals~     through their critical care units in a Provincial Network.~   "
246037|NCT00332969|"~     This study will investigate the efficacy of treatment with octroetide in patients with~     primary inoperable thymoma to reduce tumor size.~   "
246038|NCT00332956|"~     This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center~     study to select a dosage and schedule of rF1V vaccine for further studies based on the immune~     response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be~     collected through Day 540. Selection of dosage and schedule will be based on GMCs and~     seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400~     healthy adult volunteers will be enrolled (100 per group) in this study.~   "
246039|NCT00332943|"~     The purpose of this study is to determine whether Barium or BariumFerumoxsil is better for~     fecal tagging in MR colonography. Patients referred to colonoscopy are offered MR~     colonography before colonoscopy. Two days before colonography, patients ingest either a~     contrast agent A (200 ml Barium sulphate solution 1g/ml)) four times a day or a 200 ml~     contrast agent B (Barium sulfate(25%) and Ferumoxil(75%)) four times a day, which will render~     fecal masses invisible on the following MR colonography. The patients are randomised to~     either contrast agent A or B. The examinations are evaluated by two independent blinded~     readers, who will rate the tagging quality of the contrast agents. The quality of tagging~     will be rated by a Visual Analog Scale (VAS) and Relative contrast (ReCon = Iwall - Ilumen/~     Iwall + Ilumen).~   "
246040|NCT00332930|"~     The objective of this phase I/II therapeutic human immunodeficiency virus (HIV) vaccine~     candidate study is to provide proof of concept for a HIV antigen delivery system in terms of~     safety, virological effects and selected immune responses in HIV infected individuals after~     cessation of antiretroviral combination therapy (ART).~   "
246041|NCT00332917|"~     This is a multicenter, 6 months open label safety extension study for all patients who are~     willing and eligible to continue from the pivotal, double-blind S308.3.001 trial~   "
246042|NCT00332904|"~     The study´s purpose is to investigate the effect of beta blockade or aldosterone antagonist~     therapy on oxygenation, peripheral and cardiac hemodynamics and humoral systems, in patients~     with liver cirrhosis.~   "
246043|NCT00332891|"~     The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with~     Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 350 mg~     and 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder~     (GAD). The secondary objectives are to evaluate the efficacy of SR58611A on disability and~     quality of life in patients with GAD and to evaluate safety of SR58611A~   "
246044|NCT00332878|"~     This study will evaluate the effectiveness of Stepping Stones, an HIV-prevention education~     program, versus a brief HIV-focused intervention, in improving sexual health and preventing~     HIV infection in young residents of rural South African communities.~   "
246045|NCT00332865|"~     Background: Dysphagia is a common side effect after radiotherapy for haed and neck cancer~     patients. It may be worsened by immobility of the throat during tube feeding. Hypothesis:~     Exercises may prevent or reduce late dysphagia. Method: Phase I study to identify the~     tolerated intensity of exercises and establish the method of measuring training intensity and~     dysphagia measurement. Endpoint: Objective dysphagia using VF and FEESST. The HN swallowing~     and HN pain endpoint of EORTC H&N35 questionnaire. Weight loss, duration of tube feeding.~   "
246046|NCT00332852|"~     This is a prospective open-label one-arm phase III trial designed to evaluate the safety and~     efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in~     postmenopausal patients with primary breast cancer.~      This trial is not recruiting patients in the United States.~   "
246047|NCT00332839|"~     Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant~     recipients to prevent graft rejection, may cause renal impairment. The aim of this study is~     to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus~     is as safe and well tolerated as a standard regimen consisting of enteric-coated~     mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic~     efficacy while resulting in an improved renal function.~   "
246048|NCT00332826|"~     The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin~     compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes~     mellitus and concurrent asthma.~   "
246049|NCT00332813|"~     We propose to develop and pilot test an intervention that addresses both sex- and~     drug-related HIV risk behavior among pregnant women in drug treatment. In the first phase of~     the study, we will conduct focus groups with pregnant women in drug treatment, as well as a~     focus group with their treatment providers, in order to determine key areas of emphasis for~     an intervention in this population. We will then develop an HIV risk behavior intervention~     for pregnant women in drug treatment, pilot the intervention with 20 women, and elicit their~     feedback regarding the intervention. Following refinement of the intervention, we will~     conduct a small randomized trial (n=60) to examine the impact of the intervention compared to~     standard care (SC). We expect that, relative to SC, participants randomized to the~     intervention condition will have lower levels of sex- and drug-related HIV risk behavior.~   "
246050|NCT00332800|"~     Undernutrition after stroke is frequent and is due to cognitive impairment, visuospatial~     perceptive deficits, hemiparesis, depression and dysphagia. The impact of intensive~     nutritional supplementation on functional outcome measures in undernourished stroke patient~     has not been studied.~   "
246051|NCT00332787|"~     This study will determine the optimal length of continuation treatment with fluoxetine for~     children and adolescents with major depressive disorder, as well as the factors that may~     contribute to positive response during acute and continuation treatment.~   "
246052|NCT00332774|"~     The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS~     0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days~     following surgery.~   "
246056|NCT00332722|"~     1. To demonstrate whether:~           i. Facet joint nerve blocks have therapeutic value beyond the duration of local~          anesthetic effect.~           ii. Adjuvant medications (Sarapin and Depo-Medrol) provide additional relief of cervical~          facet joint pain when used with facet joint nerve blocks.~        2. To demonstrate whether or not there are clinically significant improvements in function~          of patients who receive cervical facet joint nerve block with or without Sarapin and~          Depo-Medrol (Group II) compared to patients randomized to Group I who receive only local~          anesthetic blocks.~        3. To determine the adverse event profile in both groups.~   "
246057|NCT00332709|"~     This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate~     the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women~     with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after~     resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or~     letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an~     infusion.~      This trial did not recruit patients in the United States.~   "
246058|NCT00332696|"~     To evaluate in combination with corticosteroid and local standard medical care the efficacy~     and safety of long-acting octreotide compared to placebo for the treatment of symptoms of~     inoperable bowel obstruction in patients with peritoneal carcinomatosis~   "
246059|NCT00332683|"~     Anterior cervical spine surgery (ACSS) is one of the most common procedures performed by~     spinal surgeons. It is associated with a 30-50% risk of developing swallowing difficulties~     (dysphagia). Although these difficulties usually improve within 6 months, for some it remains~     a significant and persistent problem.~      We hypothesize that lowering the cuff pressure will lower the risk of injury to soft-tissues~     in the neck that are important to swallowing function. Our objective in this study is to~     demonstrate a lower occurrence of swallowing problems after anterior cervical spine surgery~     in patients with lower endotracheal tube cuff pressure during surgery.~      Forty patients will be randomly assigned to a treatment group or control group. The treatment~     group will have the cuff pressure maintained at 15mmHg during the entire duration of the~     procedure. The control group will have the cuff pressure monitored without manipulation.~     After surgery soft-tissue swelling will be assessed on the five routine neck x-rays taken. In~     addition, 3 questionnaires completed before surgery and at each scheduled follow-up~     appointment will measure and track changes in swallowing over time and assess the impact of~     swallowing function on the patient's overall health. The results of this study may show that~     making a minor, inexpensive change during an operation may lower the risk of swallowing~     difficulties after a relatively common surgery.~   "
246060|NCT00332670|"~     The purpose of this study is to investigate the following two hypotheses:~        1. Treatment with bright light improves their sleep, mood, concentration and~          self-sufficiency of elderly depressed subjects. This clinical improvement is accompanied~          by decreases in cortisol/DHEA ratio and increases in melatonin concentration in urine~          and saliva.~        2. The eventual beneficial effect of bright light treatment can be predicted by the~          presence of sleep-wake rhythm disturbances as found using muscle activity registration,~          and by cortisol/DHEA and melatonin concentrations in saliva and urine over the day and~          the night.~   "
246061|NCT00332657|"~     The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15~     mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular~     degeneration (AMD) in patients who are at-risk for progressing to wet AMD.~   "
246062|NCT00332644|"~     The proposed work will advance the understanding and effectiveness of tobacco dependence~     treatment and result in more smokers quitting successfully.~   "
246063|NCT00332631|"~     At least 14% of patients develop kidney failure after cardiac surgery. Although this kidney~     failure can usually be treated effectively, a longer stay in intensive care is often~     required. While many patients suffer no long term ill effects after developing post-operative~     kidney failure, some require long term kidney dialysis. The investigators also know that~     patients who develop post-operative kidney failure are much more likely to die before they~     leave hospital.~      Why some people develop kidney failure after cardiac surgery is not known. However, doctors~     suspect that the process of cardiopulmonary bypass (where the functions of the heart and~     lungs are taken over by a machine during the operation, to allow the surgeon to operate)~     overactivates some of the same mechanisms the body uses to defend itself against severe~     infection. Many of the cell changes by which severe infection causes kidney failure also~     occur after cardiopulmonary bypass. One of the main overactive defence mechanisms is the~     release of highly toxic compounds derived from oxygen - a process called 'oxidative stress'.~      Another well-known cause of oxidative stress is paracetamol (Panadol) overdose. In large~     doses the oxidative stress caused by paracetamol damages cells in the liver, where it is~     digested, and the kidney. N-acetylcysteine is a drug in common use for the treatment of~     paracetamol overdose. Patients who would otherwise die of liver failure are routinely saved~     by N-acetylcysteine, which acts as a strong anti-oxidant.~      The investigators believe that N-acetylcysteine might similarly reduce the oxidative stress~     which occurs during cardiac surgery, and so prevent or decrease the kidney failure which~     occurs in many patients. The investigators hope to give N-acetylcysteine (in similar doses to~     those used safely for paracetamol poisoning) to patients during, and for a day after cardiac~     surgery, and compare the effects with patients who have not had N-acetylcysteine. The drug,~     or a 5% glucose placebo, will be given through the drip which is present in all cardiac~     surgery patients. Whether a particular patient receives the drug or placebo will be decided~     at random, and neither the patient nor the investigators will know which has been given. The~     investigators will measure kidney function before and after the operation using the standard~     tests which are performed for the purposes of clinical care of every patient. Also, the~     investigators will do an extra test involving the collection of urine (from the urinary~     catheter every patient has after cardiac surgery), which provides an even better measure of~     kidney function. This is a potential benefit to the patient, as while this test is not~     routinely performed, the results will be available to the doctors in the intensive care unit.~     The investigators will also take four 20ml samples of blood, spaced before, during, and after~     the operation, from the arterial catheter routinely inserted in every patient. This is an~     insignificant amount of blood compared to that taken for other tests, and would have no~     adverse effects. This blood would be used to measure oxidative stress, and also some of the~     proteins inside the blood cells which are responsible for creating the toxic oxygen~     compounds. In this way the investigators will discover not only the effect of~     N-acetylcysteine, but the mechanism of that effect.~      N-acetylcysteine is routinely used to treat paracetamol overdose with few side effects. An~     itchy skin rash is the only common side effect. Sometimes patients develop nausea and~     vomiting, but the treatment for this is usually very effective, and the drug will be stopped~     if it occurs. Rarely, as with all drugs, allergic reactions have been reported, but there are~     no other reported adverse effects.~      There will be no extra risk to a patient who participates in the study, and no discomfort~     other than that normally associated with cardiac surgery. The itchy rash which occasionally~     develops with N-acetylcysteine would occur under anaesthetic, and would almost certainly be~     gone by the time the patient wakes up.~      Informed consent will be obtained from the patient prior to the operation by one of the~     investigators or the ICU research nurse.~   "
246064|NCT00332618|"~     The objective of the trial was to evaluate the efficacy and clinical safety and acceptability~     of Oxygenated Glycerol Triesters in the relief of symptoms of xerostomia versus a reference~     comparator.~   "
246065|NCT00332605|"~     The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine~     (NAC) in combination with naltrexone in methamphetamine dependence.~   "
246066|NCT00332592|"~     NEC is a serious inflammatory bowel disease, which almost only strikes infants with low birth~     weight and low gestational age. The morbidity and mortality rates are high, and early~     diagnosis and treatment is mandatory. The primary aim of the present study is to investigate~     the clinical use of intragastric microdialysis and whether it is able to select patients, who~     may benefit from either medical or surgical therapy. The aim of intraperitoneal microdialysis~     is to evaluate whether changes in intraperitoneal microdialysis reflect the clinical outcome~     after laparotomy.~   "
246067|NCT00332579|"~     The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in~     kleptomania.~   "
246068|NCT00332566|"~     This booster study will assess the immunogenicity, reactogenicity and safety of a booster~     dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy~     children, 18 to 24 months of age, who received the same vaccine for primary vaccination.~     Prior to the booster dose, this study will also assess the persistence of antibodies to the~     vaccine antigen components administered in the primary vaccination course. The Protocol~     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
246069|NCT00332553|"~     This pilot study was designed to explore the effects of combined treatment with raloxifene~     HCl 60 mg and oral 17 beta-estradiol 1mg/day on the number of vasomotor episodes (hot flashes~     plus night sweats) in postmenopausal women discontinuing continuous combined hormone~     replacement therapy (ccHRT) compared to women treated with raloxifene HCl 60 mg alone.~   "
246070|NCT00332540|"~     The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed~     Combination in patients with glaucoma or ocular hypertension~   "
246091|NCT00332202|"~     This clinical research study is to investigate the prevention of relapse in patients with~     diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.~      This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the~     chance of receiving Enzastaurin is 2 to 1.~   "
246092|NCT00332189|"~     The objective of this study is to evaluate the safety of long-term treatment with Phenoptin~     in subjects with phenylketonuria (PKU) who participated in Phase 3 clinical studies with~     Phenoptin.~   "
246071|NCT00332514|"~     The purpose is to analyze whether a follow-up telephone call by a pharmacist after patient~     discharge from the hospital can improve patient outcomes.~      Patients will be interviewed via telephone within 72 hours of being discharged home from the~     hospital. Patients will be questioned on three main topics. They are:~        1. Medical care~        2. Medications~        3. Follow-up appointments~      The purpose is to find out if people understand discharge medications, have obtained those~     medications, are having any problems with their medications and have scheduled necessary~     follow-up appointments. It will be determined if a telephone call by a pharmacist will~     prevent patients from needing to go to the Emergency Room or being admitted back to the~     hospital.~   "
246072|NCT00332488|"~     to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin~     versus combination metformin and a secretagogue~   "
246073|NCT00332462|"~     The aim of this exploratory study is to evaluate the rejection rate in patients treated with~     cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo~     liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h~     monitoring. In addition, this study will assess the safety of this treatment regimen.~   "
246074|NCT00332449|"~     Early breast feeding has shown to be important to mother-infant bonding and is associated~     with longer duration of breast feeding. However, little data is available regarding its~     contribution to glucose levels in the newborn infants. Newborns that are at risk to develop~     hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum~     hypoglycemia.~   "
246075|NCT00332436|"~     The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed~     Combination in patients with glaucoma or ocular hypertension~   "
246076|NCT00332410|"~     The purpose of this study is to determine whether patients with compromised renal function~     (CrCl < 50mL/min) receiving intravenous voriconazole experienced any adverse effects related~     to serum chemistries or other imaging studies of the kidney due to the potential accumulation~     of the vehicle cyclodextran.~   "
246077|NCT00332397|"~     The purpose of this study is to evaluate the efficacy of 3 different drug-eluting-stent~     platforms to reduce coronary artery reblockage after stent implantation~   "
246078|NCT00332384|"~     The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed~     Combination in patients with glaucoma or ocular hypertension~   "
246079|NCT00332371|"~     The study objective is to clarify whether the application of CPFA (coupled plasma-filtration~     adsorption) in addition to the current clinical practice is able to reduce mortality and~     prevent organ failures in septic shock patients in intensive care unit (ICU).~   "
246080|NCT00332345|"~     The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed~     Combination in patients with glaucoma or ocular hypertension~   "
246081|NCT00332332|"~     The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of~     psoriasis in patients for a period of up to 1 year.~   "
246082|NCT00332319|"~     This is a two-part study in which Part A will assess the effects of GW679769 after 1 dose on~     the function of the nerves that supply the bladder. The technique for measuring the nerves~     function is called Neurometry. Part B will assess the effect of repeat doses of GW679769 on~     the bladder nerve function. Part B will also assess the effects of the drug on overactive~     bladder symptoms using a three-day patient diary.~   "
246083|NCT00332306|"~     Protocol Summary~      Title: Evaluation of safety and efficacy of two different once daily anti-retroviral~     treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and~     tuberculosis - Randomized Controlled Clinical Trial~      Phase: Phase III trial~      Population: 180 HIV-1 positive patients with tuberculosis~      Number of Sites: Four.~        1. Tuberculosis Research Centre, Chennai~        2. Government Medical College, Vellore~        3. Government Hospital of Thoracic Medicine, Tambaram~        4. Government Rajaji Hospital, Madurai~      Study Duration: 26 months including 24 months of ART.~      Study Objectives:~      Primary Objective To compare the efficacy and safety of two different once-daily~     anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in~     patients with HIV-1 and tuberculosis, by using virologic end points.~      Secondary Objective To compare the efficacy of antiretroviral treatment given under partial~     supervision with unsupervised treatment (once a month supply).~   "
246084|NCT00332293|"~     The purpose of the study is to determine whether AL-15469A is safe and effective in the~     treatment of bacterial conjunctivitis.~   "
246085|NCT00332280|"~     The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer~     patients with advanced disease.~      The primary evaluation criterion is clinical benefit response.~   "
246086|NCT00332267|"~     The objective of the present protocol is to study whether a low level of oxygen in the blood~     will affect the immune response to as well as cerebral blood flow and metabolism during an~     infection and, conversely, whether the acute systemic and cerebral physiologic response to~     hypoxia is modified by an ongoing inflammatory response.~   "
246087|NCT00332254|"~     Individuals who have had a severe knee injury have an increased risk of developing arthritis~     of the knee and at a much earlier age than would otherwise be expected. The swelling and~     inflammation that occur after injury are believed to be responsible for this cartilage~     damage. The cartilage (material that provides a cushion in the knee) is the primary~     protection from what is called degenerative arthritis or osteoarthritis. We hope to reduce~     this swelling and prevent the damage to cartilage that occurs after injury by injecting a~     medication that blocks one of the proteins responsible for inflammation and cartilage~     breakdown. This protein is called interleukin-1 and can be inhibited by an interleukin-1~     receptor antagonist called anakinra. Anakinra will be injected directly into the injured knee~     and response to the injection will be measured by symptoms and analysis of cartilage~     breakdown in the knee fluid and blood.~   "
246088|NCT00332241|"~     This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly~     dosed with a placebo, in reducing serious behavioral problems in children and adolescents~     with a diagnosis of autistic disorder (AD).~   "
246089|NCT00332228|"~     The overall goal of this research project is to test the efficacy of a newly developed~     therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone~     maintenance and long-term abstinence for individuals with heroin dependence. This study~     includes free detox and outpatient treatment for opioid dependence that includes medication~     and a behavioral intervention.~   "
246093|NCT00332176|"~     The objective of this study is to undertake an initial evaluation of the safety,~     tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with~     peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.~   "
246094|NCT00332163|"~     A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in~     patients with metastatic colorectal cancer (mCRC) who are receiving second-line~     irinotecan-based chemotherapy concomitantly with panitumumab.~   "
246095|NCT00332150|"~     Parental approval to enroll their sick children in clinical research was studied. However,~     the motivation of parents to enroll healthy children and/or babies was not yet studied. The~     importance of clinical research among the healthy population is of extreme value. The aim of~     this study is to assess the motivation, medical trust and other factors influencing parents'~     decision to enroll their healthy baby in a clinical study.~   "
246096|NCT00332137|"~     The muscarinic antagonist tolterodine is widely used treat urinary urge incontinence. Though~     acteylcholine is the primary excitatory neurotransmitter in the gastrointestinal tract, the~     phase III trials suggest that tolterodine infrequently causes constipation. Therefore, the~     objectives of this study are to assess if tolterodine affects the speed at which food travels~     through the stomach, intestines and colon (i.e., gastrointestinal and colonic transit) in~     healthy subjects.~   "
246097|NCT00332124|"~     This study will evaluate the safety and effectiveness of taking choline supplements during~     pregnancy, and whether choline supplementation has an effect on infant development.~   "
246098|NCT00332111|"~     The proposed protocol aims to characterize the infectious episodes in pancreas transplant~     recipients under the current medical care. Knowing these patients infectious risks, the types~     of infections that commonly affect them and the morbidity and mortality associated with it~     will provide valuable information in the evaluation of the safety and efficacy of the current~     practices. The information generated by this study will also serve as the basis for~     development of strategies targeting prophylaxis of infectious episodes.~   "
246099|NCT00332098|"~     This study will evaluate the effectiveness of family-focused treatment (FFT) plus~     pharmacotherapy in treating adolescents with bipolar disorder.~   "
246100|NCT00332085|"~     This pilot trial seeks to gather preliminary data on the combination of chromium picolinate,~     the most commonly used form of chromium, and metformin. The trial will recruit type 2~     diabetes subjects already on metformin and treat them with chromium for 8 weeks. The results~     of this trial will provide vital preliminary data including safety and size of effect to~     direct future studies.~   "
246101|NCT00332072|"~     The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed~     Combination in the treatment of glaucoma or ocular hypertension~   "
246102|NCT00332059|"~     The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed~     Combination in patients with glaucoma or ocular hypertension~   "
246103|NCT00332046|"~     Evidence suggests the use of neuroimaging to detect therapeutic effects of anxiolytic~     treatment when appropriate cognitive-emotional tasks are use to activate the emotional brain~     neurocircuitry believed to be involved in the core symptoms of the disease.~   "
246104|NCT00332033|"~     Uterine leiomyomas (fibroids) represent a major public health problem with few effective~     therapies. Currently, the only definitive treatment is hysterectomy and women are demanding~     alternative therapies to surgery. We have developed a new approach to the treatment of~     uterine fibroids based on collaborative laboratory research into the molecular,~     ultra-structural, and histopathologic changes that occur with the transformation of normal~     uterine myocytes into abnormal myocytes comprising uterine fibroids. We have confirmed that~     excessive, dysregulated collagen production (fibrosis) and abnormal collagen deposition is an~     underlying etiology in the pathogenesis of leiomyoma. We will test the hypothesis that an~     anti-tumor drug (Pirfenidone) will decrease the size of clinically relevant leiomyomas by~     30%. The specific aim is to compare the effects of pirfenidone with placebo on uterine~     leiomyoma volume. Thirty-two (32) women will be randomized in a double-blinded treatment~     design. Inclusion criteria include women that have completed child-bearing, who are~     candidates for hysterectomy, are using effective contraceptive, and have at least one uterine~     leiomyoma greater than 4 cm diameter confirmed by ultrasound. Women will be excluded if they~     have a body mass index greater than 33 kg/m(2), other gynecological diseases, and history of~     cardiovascular disease or smoking. Response in each treatment group will be assessed by T-2~     weighted magnetic resonance imaging (MRI) and 3-D ultrasound imaging studies during the~     enrollment period. To our knowledge, this will be the first study to document the response of~     large fibroids to a short-term trial of an anti-tumor drug. The data will be used to further~     define the role of fibrosis in leiomyoma and establish other clinical trials to thoroughly~     evaluate such therapeutic approaches for uterine leiomyomas.~   "
246105|NCT00332020|"~     The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is~     safe and can help prevent blood clots forming after a hip replacement operation.~   "
246106|NCT00332007|"~     Overall trial objectives:~        1. Can treatment with tonabersat reduce the number of days with aura and/or migraine~          headache in patients with migraine with aura~        2. How well tolerated is treatment with tonabersat~      The study is based on the hypothesis that the unique mechanism of action of tonabersat will~     inhibit some of the early events in the generation of aura and migraine headache and so be~     effective as prophylactic treatment~   "
246107|NCT00331994|"~     Primary objective: to assess the efficacy of Bacillus clausii versus metronidazole in the~     eradication of the small intestinal bacterial overgrowth, 30 days after the end of treatment.~      Secondary objective: to assess the efficacy of Bacillus clausii versus metronidazole in~     avoiding recurrence of the small intestinal bacterial overgrowth, 90 days after the end of~     the treatment; to assess the efficacy of Bacillus clausiiversus metronidazole in improving~     irritable bowel syndrome -related symptoms; to assess the efficacy of Bacillus clausii versus~     metronidazole in the satisfactory relief of overall irritable bowel syndrome symptoms and of~     abdominal discomfort or pain; to assess the efficacy of Bacillus clausii versus metronidazole~     in improving irritable bowel syndrome quality of life.~   "
246108|NCT00331981|"~     Primary purpose:~        -  To find out how effective is long term treatment with amisulpride on the positive and~          negative symptoms in schizophrenic patients~        -  To find out how safe is long term treatment with amisulpride in schizophrenic patients~      Secondary purpose:~        -  To find out how effective is long term treatment with amisulpride on the quality of life~          in schizophrenic patients~        -  To find out how effective is long term treatment with amisulpride on the cognitive~          function in schizophrenic patients~   "
246490|NCT00326781|"~     The purpose of this research study is to:~        1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking~          cessation; and~        2. identify predictors of response to these alternate forms of nicotine replacement therapy~          (NRT).~   "
246109|NCT00331955|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with doxorubicin in treating patients with metastatic or locally advanced solid~     tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as doxorubicin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Vorinostat may help doxorubicin work better by making tumor cells more sensitive to~     the drug.~   "
246110|NCT00331942|"~     To determine the ability of the Cimmunology process to lead to in vitro antibody production,~     the ability of the ELISA assays to detect any of those antibodies, and to establish the~     relationship between the ELISA results and the clinical / pathological status of the patient.~     The statistical significance of the CAAb test results will be determined.~   "
246111|NCT00331929|"~     Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate~     the health status of children living in K. Tivon.~      The health status will be evaluated using health questionnaires and spirometry.~   "
246112|NCT00331916|"~     The purpose of the study is to determine whether AL-15469A is safe and effective in the~     treatment of bacterial conjunctivitis.~   "
246113|NCT00331890|"~     Citicoline is a safe drug approved in some countries for the treatment of acute ischemic~     stroke. The drug has shown some evidence of efficacy in a pooled analysis, based on four~     clinical trials done in USA with oral citicoline.The purpose of the study is confirm the~     results obtained in the pooled analysis, that is, evidence of efficacy in the treatment of~     acute ischemic stroke~   "
246114|NCT00331877|"~     Decisions to limit life sustaining treatments are made for most patients dying in the ICU,~     usually with input from the family. The well-being of the family may be jeopardized by~     involvement in the decision-making process and bereavement. We evaluated the ability of a~     proactive communication strategy (family conference and providing family members with a~     bereavement information leaflet) designed to improve family well-being.~   "
246115|NCT00331864|"~     Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human~     vascular endothelial growth factor A. This study will assess the safety and efficacy of~     ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal~     neovascularization (CNV) secondary to age-related macular degeneration (AMD).~   "
246116|NCT00331851|"~     This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to~     show the effect of treatment with liraglutide added to existing glimepiride and metformin~     combination therapy and to compare it with the effects of insulin glargine added to~     combination therapy of glimepiride and metformin.~   "
246117|NCT00331838|"~     The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026)~     for the prevention of Venous Thromboembolism [VTE] in patients undergoing total knee~     replacement [TKR] surgery.~      Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to~     document the efficacy and safety of AVE5026 post-operative regimens, and to assess the~     pharmacokinetic parameters of AVE5026.~   "
246118|NCT00331825|"~     We initiate a study with research grant from department of health and Taoyuan mental hospital~     and choose risperidone and olanzapine as study medications. We compare the incidence of using~     anticholinergic drugs in schizophrenic patients of Han ethnics with neuroleptic-induced acute~     dystonia or parkinsonism to test the hypothesis that these two medications have different EPS~     incidence in EPS intolerant population.~   "
246119|NCT00331812|"~     In Amyotrophic Lateral Sclerosis (ALS), malnutrition is frequent (16 to 50 % of the patients)~     and is an independent prognostic factor. One of the implicated factors is the increase of~     resting energy expenditure (REE) which can be found in about 50 % of ALS patients. The origin~     of this hypermetabolism is currently unknown but could be located in the mitochondria. In~     fact, some studies have found mitochondrial abnormalities and the existence of an oxidative~     stress. Thus, the aim of this study is to characterize the mitochondrial abnormalities and~     the oxidant/antioxidant status of ALS patients and to determine their relationship with the~     metabolic status, hypermetabolism or normometabolism. Three groups of patients will be~     studied : 20 hypermetabolic ALS patients, 20 normometabolic ALS patients and 20 healthy~     volunteers paired for age and sex.~   "
246120|NCT00331799|"~     The purpose of this study is to explore benefits of duloxetine in enhancing psychological~     resilience and to understand the relevance of inhibiting of both serotonin (5HT) and~     norepinephrine (NE)to therapeutic responses.~   "
246121|NCT00331786|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of nitric oxide-releasing acetylsalicyclic acid may prevent~     colorectal cancer.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of nitric~     oxide-releasing acetylsalicyclic acid in preventing colorectal cancer in patients at high~     risk of colorectal cancer.~   "
246122|NCT00331773|"~     RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to~     help focus thin beams of radiation directly on the tumor, and giving hypofractionated~     radiation therapy (higher doses over a shorter period of time), may be less costly with fewer~     side effects and just as effective in treating prostate cancer.~      PURPOSE: This randomized phase III trial is studying several different radiation therapy~     regimens to compare how well they work in treating patients with stage II prostate cancer.~   "
246123|NCT00331760|"~     RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy~     (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor~     cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with~     or without chemotherapy after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to~     the pelvis with or without chemotherapy works in treating patients with endometrial cancer or~     cervical cancer that has been removed by surgery.~   "
246124|NCT00331747|"~     Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple~     sclerosis (MS) patients.~      During the study patients will undergo a 3 dimensional gait analysis before starting~     treatment with glatiramer acetate and after 1 year of treatment.~   "
246125|NCT00331721|"~     The main objective of this study is to investigate the tolerability of enecadin in patients~     with acute ischemic stroke. Furthermore, the pharmacokinetics of enecadin in both male and~     female patients with acute ischemic stroke will be assessed. Efficacy trends will be~     evaluated up to day 30 post stroke.~   "
246126|NCT00331708|"~     The main purpose of this study is to compare the drug levels of artesunate and~     sulfadoxine-pyrimethamine found in pregnant women with malaria to those drug levels found in~     non-pregnant women from other studies. In addition the efficacy and safety of the study drugs~     will be determined for pregnant women and their babies.~   "
246127|NCT00331695|"~     To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones~     caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by~     the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20~     and 32 weeks of gestation and:~        -  either a first episode of preterm labor stopped by acute tocolysis;~        -  either a history of late miscarriage or premature delivery or uterine malformation or~          DES~        -  either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed~          with initial stratification according to these three risk groups, opened with two~          parallel arms.~   "
246128|NCT00331682|"~     Drugs used in chemotherapy, such as docetaxel and flavopiridol, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Flavopiridol may also help docetaxel work better by making tumor cells more sensitive to the~     drug. This phase II trial is studying how well giving docetaxel followed by flavopiridol~     works in treating patients with refractory metastatic pancreatic cancer.~   "
246129|NCT00331669|"~     The purpose of this randomized, double blind, multi-center study is to assess the efficacy~     and safety of bilateral pallidal deep brain stimulation in patients with tardive dystonia.~   "
246130|NCT00331656|"~     Non-invasive ventilation has become increasingly important in the management of patients with~     acute respiratory failure. One of its major goals is to prevent the need for invasive~     ventilation, which is associated with numerous complications. This study compares the~     usefulness and safety of two noninvasive techniques which are used in Medical practice:~     Noninvasive positive pressure ventilation using a face mask and extrathoracic biphasic~     ventilation using a cuirass. Each of these techniques has advantages and disadvantages and~     both may not suit all patients. It is therefore important to compare the two in terms of~     effectiveness in preventing invasive ventilation and their side effects profile, so that we~     can improve our understanding and expertise in the treatment of patients in respiratory~     failure.~   "
246131|NCT00331643|"~     This phase II trial is studying how well ixabepilone works in treating young patients with~     refractory solid tumors. Drugs used in chemotherapy, such as ixabepilone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~   "
246132|NCT00331630|"~     RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their~     growth. Giving Abraxane together with lapatinib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving Abraxane together with lapatinib~     works in treating patients with stage I, stage II, or stage III breast cancer.~   "
246133|NCT00331604|"~     This trial is conducted in Asia, Europe and South America. The aim of this research is to~     compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary~     function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart~     both in combination with insulin detemir in Type 2 Diabetes.~   "
246134|NCT00331578|"~     The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of~     coronary heart disease and inhibition of restenosis after coronary artery stenting as well as~     a 12 months' long-term safety after the cessation of clopidogrel as an anti-platelet drugs~     used for 6 months after the implantation of degradable drug coating stent.~   "
246135|NCT00331565|"~     Altered bioavailability of drugs will potentially affect both drug efficacy as well as~     safety. In patients subjected to bariatric surgery due to morbid obesity the gastro~     intestinal tract is considerably reconstructed and a change in drug bioavailability is very~     likely. Getting further knowledge on important mechanisms responsible for altered~     bioavailability would help in predicting clinically relevant consequences on different drugs.~      In the present study we aim to investigate the effect of bariatric surgery on atorvastatin~     bioavailability. Atorvastatin is subjected to both extensive metabolism and drug transport~     and will potentially be a good predictor for mechanisms relevant for other drugs as well.~      In addition will the expression of different enzymes and transporters be measured in the~     gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual~     effects.~   "
246136|NCT00331552|"~     Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and cyclophosphamide,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Giving more~     than one drug (combination chemotherapy) together with trastuzumab may be a better way to~     block tumor growth.~   "
246137|NCT00331539|"~     Cochlear implants require programming on an individual basis to provide appropriate levels of~     electrical stimulation. This program, or map, is placed in the speech processor of the~     cochlear implant. Success of implantation largely depends on the adequacy of this map.~     Cochlear implant fitting remains a difficult challenge in congenitally or pre-linguistically~     deafened children. It requires competence of experienced audiologists with expertise in~     behavioral techniques for hearing function assessment.Our goal is to establish the offset~     correlation between objective measurements (NRT and ESRT) and the behavioral measurements of~     T & Cs in different stimulation rates in the Freedom SP System.~   "
246350|NCT00328666|"~     The purpose of this study is to compare the effects of 12 weeks of structured classes of~     either iyengar yoga (IY) or an enhanced usual care intervention on blood pressure, heart rate~     variability, quality of life measures, lipid measures, and safety in patients with~     high-normal to stage I hypertension.~   "
246138|NCT00331526|"~     RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the~     immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate~     the white blood cells, including lymphokine-activated killer cells, to kill tumor cells.~     Giving cellular adoptive immunotherapy during or after surgery may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well cellular adoptive immunotherapy works in~     treating patients with glioblastoma multiforme.~   "
246139|NCT00331513|"~     This randomized phase I trial is studying the side effects and best dose of vorinostat when~     given together with idarubicin in treating patients with relapsed or refractory leukemia or~     myelodysplastic syndromes. Drugs used in chemotherapy, such as vorinostat and idarubicin,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Vorinostat may also stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Giving vorinostat together with idarubicin may~     kill more cancer cells.~   "
246140|NCT00331500|"~     The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in~     the treatment of the signs and symptoms associated with allergic conjunctivitis or~     rhinoconjunctivitis.~   "
246141|NCT00331487|"~     Efficacy comparison of Pioglitazone, once daily (QD), to Rosiglitazone in participants with~     Type 2 Diabetes~   "
246142|NCT00331474|"~     Background:~      Each year, more than half a million babies are infected with HIV by mother-to child~     transmission in developing countries. Many of these babies get sick and develop HIV disease~     (AIDS) at a very young age. Exposure to other infectious diseases may influence this early~     progression to AIDS. BCG is a live tuberculosis vaccine made from cow tuberculosis. It is~     routinely given at birth to most babies, also to babies born to HIV-positive mothers. BCG can~     cause disease (BCGosis) in HIV-infected babies. More importantly, BCG may also trigger immune~     responses in the body that lead to the spread of the HIV virus and early progression to AIDS.~      Objective(s) and Hypothesis:~      The researchers will investigate whether BCG causes progression of HIV by doing a clinical~     trial: babies born to HIV-positive mothers will be randomly allocated to get the BCG vaccine~     at birth or at 14 weeks of age. In these 2 groups of babies, the researchers will compare:~        -  The percentage of babies who progress to HIV disease~        -  Blood markers of HIV disease (the amount of virus and protective white blood cells in~          the body)~        -  The body's immune response to BCG vaccine and other childhood vaccines~        -  The percentage of children who develop BCG scarring, BCG vaccine complications and~          tuberculosis.~      Potential Impact:~      BCG is the most widely given vaccine worldwide and is routinely given to babies born to~     HIV-positive mothers in developing countries. Any effect that BCG has on HIV progression in~     babies will have a significant public health impact in settings with a high burden of HIV~     disease.~   "
246143|NCT00331448|"~     The purpose of this study is to collect data on the body's breakdown of sugar and fat in HIV~     infected adults. Data from this study will make clearer the roles of HIV infection and~     anti-HIV drugs in the development of diabetes, heart disease, and fat redistribution in HIV~     infected adults.~   "
246144|NCT00331435|"~     The purpose of this study is to evaluate and conduct an exploratory comparison of the~     efficacy and safety of indocyanine green angiography (ICGA) guided photodynamic therapy (PDT)~     and fluorescein angiography (FA) guided PDT for exudative age-related macular degeneration~     (AMD) accompanied with polypoidal choroidal vasculopathy (PCV).~   "
246145|NCT00331422|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or stopping them from~     dividing. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin~     before surgery works in treating patients with advanced ovarian epithelial cancer, fallopian~     tube cancer, or primary peritoneal cavity cancer.~   "
246146|NCT00331409|"~     RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Everolimus may also block blood flow to the~     tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib~     mesylate works in treating patients with metastatic or unresectable kidney cancer.~   "
246147|NCT00331370|"~     Damage to very small blood vessels is a consequence, but can also precede high blood~     pressure. Such damage, measured by disturbances in the vessels in the retina (back of the~     eye) is a strong predictor of heart disease and stroke. South Asian people have one of the~     highest rates of hypertension in the world (30% in adults). In Pakistan, this is usually~     severe, undetected and untreated. The Wellcome Trust has already funded a study of blood~     pressure control in adults and children in this population. We propose a substudy, taking~     photographs of the retina and making measurements of the vessels, to determine whether such~     blood pressure related changes occur at an early age in young children with a family history~     of high blood pressure compared to those without, whether such changes predict an increase in~     blood pressure over time, and whether, in adults, such changes can be reversed by blood~     pressure treatment. The hypothesis of our study is: young offspring of South Asian people~     with hypertension have a disturbed microcirculation, as assessed by abnormalities of retinal~     vessels, compared to offspring of normotensive parents. Our 2nd hypothesis is: Abnormal~     retinal vascular geometry will improve proportionately to achieved reductions in BP.~   "
246148|NCT00331357|"~     The objective of this study is to describe a paediatric population presenting an acute~     idiopathic thrombocytopenic purpura (ITP) and their evolution during their therapy in the~     region Pays de la Loire. The study will particularly evaluate the quality of life of these~     patients and their parents.~      The secondary objectives are to identify the predictive factors of the complications, the~     repetitions and the chronicity of the ITP, to estimate the principal parameters of the~     economic cost of therapy of the children suffering from ITP according to the protocol of~     therapy, set up in the region Pays de la Loire and the constitution of a blood sample~     collection which allow a better understanding of the physiopathology of this disease.~      It is about a prospective, multicentric clinical epidemiologic study of a paediatric cohort.~     Patients: 100 children from 0 to 17,99 years suffering from a first discovered ITP. The~     patients are not included if they present a serious, intercurrent, stabilized chronic~     pathology or not likely to modify the quality of life of the child and if they present a~     pathology other than the thrombopenia bringing into play the vital prognosis within a time~     lower than one year. These patients will be followed for 6 months according to the diagnosis~     of their ITP.~      During the 6 months follow-up of each patient, the study will not carry out more~     consultations, nor more blood tests than the usual follow-up of a child suffering from ITP.~     On the other hand, in addition to the J0 questionnaire, it will be requested to the patient~     and to his family to fill in the questionnaires of quality of life and way of life during the~     consultations of J8, 1 month, 3 months and 6 months. A check-up of autoimmunity at 6 months~     will be carried out if the thrombopenia persists (this check-up is usual and not-specific to~     the study). At the time of the blood test for the control of the platelets at J0 and 6~     months, an additional blood sample will be carried out: 5 ml are taken for the children of an~     age ≤ at 2 years, 10 ml from 2 to 4 years and 15 ml of blood for the children of an age > at~     4 years. These blood samples are intended for the constitution of a blood sample collection.~      The protocol of therapy of the children suffering from ITP is homogeneous in all centers,~     this protocol being a consensus established by the network of Oncopaediatrics of the Pays de~     la Loire. The instituted treatment will be in function of the gravity of the ITP expressed in~     4 stages:~      Stage I: Platelets > 20 gigas/L and absence of clinical signs. Stage II: Platelets > 10~     gigas/L and hemorrhagic signs: haematomas, petechias or occasional epistaxis without~     repercussion on the daily life.~      Stage III: moderate. Platelets > 10.000/mm3 and epistaxis with gauze pluggings or mucous~     lesions.~      Stage IV: severe. Platelets ≤ 10.000/mm3 or fall of 2 grs/dl of haemoglobin with bleedings:~     epistaxis, melaena or haemorrhages requiring a blood transfusion or an hospitalization and~     important changes in the activities of the daily life.~      Stages I and II do not receive any treatment and benefit from a simple monitoring.~      Stages III benefit from either a corticosteroid treatment (Méthylprednisolone or Prednisone)~     at the dose of 4 mg/kg and per day in 2 intervals during 4 days (maximal dose of 100 mg/day)~     or a monitoring according to the appreciation of the clinician.~      Stages IV profit in first intention from a treatment by Méthylprednisolone or Prednisone at~     the dose of 4 mg/kg and per day in 2 intervals during 4 days (maximal dose of 100 mg/jour).~      The therapeutic attitude and the stadification belong to a regional consensus, established~     before the study, but each one can decide to apply a treatment according to the gravity of~     the clinical state of the child.~   "
246149|NCT00331344|"~     This phase I/II trial is studying the side effects and best dose of ixabepilone and~     mitoxantrone hydrochloride when given together with prednisone and to see how well they work~     in treating patients with metastatic prostate cancer that did not respond to hormone therapy~     and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone~     hydrochloride, and prednisone, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells~   "
246222|NCT00330382|"~     This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works~     in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain~     substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk~     inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients~     with oral leukoplakia~   "
246150|NCT00331331|"~     This study will examine the proteins of people with uveitis, or inflammation of the eyes.~     Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back~     of the lens, is now possible with the use of new microtechnology. There is an opportunity to~     evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening~     uveitis.~      Patients ages 18 and older who have been enrolled in the Multicenter Uveitis Steroid~     Treatment (MUST) study at NIH may be eligible for this study. Up to 200 patients eventually~     may be enrolled. Researchers will study the vitreous that will be removed from patients' eyes~     during an operation to insert a steroid implant. The steroid implant is used instead of~     immunosuppressive therapy, a way to reduce the action of the immune system.~      Patients will undergo a procedure involving a small hole made in the eye into which the~     implant is placed. Normally a small amount of the vitreous comes out during that procedure,~     and in this study, the vitreous specimen will be taken for testing of inflammatory products.~     At the same time, a small sample of blood, about 1-1/2 tablespoons, will be collected so that~     the researchers can compare inflammatory products that may be in the blood with those in the~     vitreous. If a patient needs to have the implant placed again during the study, he or she~     would be asked permission for collection of the vitreous and blood samples, as previously.~     Samples collected will not be used to diagnose patients' conditions or to change any~     treatments being done. All samples will be labeled with special code numbers so that there is~     no identifying information about patients. This study will not involve examinations or~     scheduled visits of patients.~   "
246151|NCT00331318|"~     This study will determine if applying electrical stimulation of the brain can influence~     training to perform finger movements. The study may provide information that can be used to~     design rehabilitation therapies for people who have lost the ability to move a part of their~     body, such as an arm, leg, or hand following a stroke.~      Healthy volunteers 18-50 years of age may be eligible for this study. Candidates are screened~     with a medical history, physical examination, MRI (if one has not been done within the last~     year), questionnaire to evaluate memory and attention and a pregnancy test for women who can~     become pregnant.~      Participants have the following tests and procedures in seven sessions over about 8 weeks:~        -  Questionnaires to test attention, fatigue and mood before, during and after each session~        -  Surface electromyography: Electrodes are filed with a conductive gel and taped to the~          skin over one small hand muscle to measure the electrical activity of muscles.~        -  Transcranial magnetic stimulation: A wire coil is held on the scalp. A brief electrical~          current passes through the coil to stimulate the brain. During the stimulation, the~          subject may be asked to tense certain muscles slightly or perform other simple actions.~          The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject~          may hear a click and feel a pulling sensation on the skin under the coil.~        -  Transcranial direct stimulation (tDCS) before and during motor training: Small, wet~          sponge electrodes are applied to the head - one above the eye and the other on the back~          of the head. A small electrical current is passed between them. The subject may feel an~          itching or tingling sensation under the electrodes or see light flashes.~        -  Motor learning under tDCS: tDCS is repeated while the subject performs the training~          task. The training task consists of performing voluntary brisk thumb movements in a~          direction opposite to TMS-induced movement directions, during 30 minutes. Training~          blocks are in 10-minute segments and tDCS is applied during the first 20 minutes.~        -  Behavioral measurements: Evaluation of learned movement tasks.~   "
246152|NCT00331305|"~     This study will evaluate the effectiveness of both center-based and home-based exercise~     versus the antidepressant drug sertraline in treating depression in middle-aged and older~     adults.~   "
246153|NCT00331292|"~     The primary goal of this study is to identify a gene or panel of genes which are~     differentially expressed in lung cells and tissue from asthmatic patients following~     administration of Ipratropium bromide and eiTher nebulised Albuterol or saline. Each subject~     in this study will undergo two bronchoscopies.~   "
246154|NCT00331279|"~     The purpose of this study is to determine whether oral cinnamon extract are effective in~     reducing insulin resistance parameters in women with polycystic ovary syndrome.~   "
246155|NCT00331253|"~     To establish the safety and efficacy of indocyanine green-mediated photothrombosis (i-MP) for~     the treatment of patients with neovascular age-related macular degeneration.~   "
246156|NCT00331240|"~     The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular~     pressure control and safety of TravTim fixed combination given once in the evening with~     placebo once in the morning versus TravTim given once in the morning with placebo once in the~     evening in patients with open-angle glaucoma.~   "
246157|NCT00331227|"~     Flavonoids are one of the many classes of natural chemicals found in a variety of foods.~     People with the highest flavonoid blood levels have the lowest rates of coronary heart~     disease. This is considered one of the reasons why high fruit and vegetable consumption is~     associated with lower rates of heart disease, although it is not known if taking a flavonoid~     supplement provides the same protection as eating fruits and vegetables.~      The purpose of this study is to determine if a particular flavonoid supplement, called~     Isotonix OPC-3, taken on a daily basis, will improve the function of arterial vessels.~     Arteries normally constrict after eating a high-fat meal. This study will examine the~     potential of the OPC-3 to lessen this constriction response. Approximately 25 people will be~     involved in this research project and participation will last for 10 weeks.~   "
246158|NCT00331214|"~     This study is designed to evaluate efficacy and safety of a testosterone patch as treatment~     for low libido in surgically menopausal women who are taking estrogen therapy.~   "
246159|NCT00331201|"~     Feeding intolerance is a common problem in the NICU. Feeding intolerance complicates the~     hospitalization, lengthens the hospital stay, and adds substantially to the cost of care. We~     developed a method aimed at treating intestinal villous atrophy. We accomplished preclinical~     testing of the product, and four Phase I clinical trials, including two at McKay-Dee Hospital~     in 2004. Our preparation is a sterile, isotonic, solution that simulates human amniotic fluid~     in electrolyte composition, albumin concentration, and two enterocyte growth factors that are~     present in human amniotic fluid; erythropoietin and granulocyte colony-stimulating factor. We~     termed the product SAFEstart, using the acronym Simulated Amniotic Fluid for Enteral~     administration. This trial on the efficacy and safety of SAFEstart administration as a~     treatment for neonates who have feeding intolerance.~      Hypothesis is that infants with feeding intolerance, randomized to the SAFEstart will have a~     greater enteral calories per kilogram per day for the seven days following conclusion of the~     SAFEstart administration.~   "
246160|NCT00331188|"~     The main objective of this study is to determine the efficacy of early administration of~     Sanvar® in combination with endoscopic treatment for the control of acute variceal bleeding.~   "
246161|NCT00331175|"~     The purpose of this trial is to evaluate the safety and tolerability of single escalating~     doses of Peptide YY3-36 and to determine effects on food intake and serum hormones when~     administered by intravenous infusion to otherwise healthy overweight adult subjects.~   "
246162|NCT00331162|"~     The purpose of this research study is to compare the effects of the two most commonly used~     anti-T cell induction agents(alemtuzumab and rabbit anti-thymocyte globulin) to prevent~     rejection in kidney and pancreas transplant patients. Alemtuzumab is Food and Drug~     Administration (FDA) approved for treating a certain type of cancer (leukemia), and~     Thymoglobulin® (rabbit anti-thymocyte globulin) is approved for anti-rejection treatment, but~     neither drug is FDA approved for administration at the time of transplantation to help~     prevent rejection. Even so, many transplant centers use these medications at the time of~     transplantation and believe that their use helps to decrease the risk of developing rejection~     following kidney and pancreas transplantation. Which drug might be better is not known.~     Subjects will receive either alemtuzumab (one administration) or rabbit anti-thymocyte (3 to~     7 doses) at and within the first week of transplantation. Subjects will be assigned to either~     the alemtuzumab or rabbit anti-thymocyte globulin groups by chance. The two groups will be~     compared to see if there are meaningful differences for survival, organ function, side~     effects, and quality of life. The follow-up care after transplant for subjects in the study~     is the same as that for patients who are not in the study, except that a quality of life~     questionnaire (estimated to take 10 minutes to complete) will be completed at the time of~     transplant and through year 2 during selected scheduled clinic visits. A retrospective chart~     review will occur at 3-5 years post-transplant to follow incidence of chronic rejection,~     patient and graft survival and graft function.~   "
246163|NCT00331149|"~     This study was designed to compare the effectiveness and tolerability of a new prolonged~     release formulation of ropinirole with the currently marketed immediate release formulation~     which is prescribed in many countries. The new prolonged release formulation allows the drug~     to be taken once a day rather than three times a day. This study will also evaluate the side~     effects of the new prolonged release formulation of ropinirole~   "
246164|NCT00331136|"~     The purpose of this study is to evaluate three dose levels of a combination of pyronaridine~     and artesunate for the treatment of uncomplicated falciparum malaria in children.~   "
246165|NCT00331123|"~     This study is designed to evaluate efficacy and safety of a testosterone patch as treatment~     for low libido in surgically menopausal women who are taking estrogen therapy.~   "
246166|NCT00331110|"~     The goal of this project is to assess the effects of an ankle strap on the effectiveness of a~     laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static~     and dynamic lower limb biomechanics. Using a repeated measures, modified cross-over design,~     the following aims and hypotheses will be addressed:~      Biomechanical Hypotheses~        1. Use of the insole with ankle strapping significantly alters hip-knee-ankle (HKA) angle~          towards 180° or talar valgus angulation.~        2. Use of the insole with ankle strapping significantly reduces peak knee external varus~          moment during gait.~        3. Use of the insole with ankle strapping significantly reduces foot external rotation~          (out-toeing) or widened base during gait analysis.~        4. The radiographic HKA angle and tilt angle of the talus will predict knee peak external~          varus moment during gait.~      Clinical Hypotheses~      1. The use of an insole with ankle strapping over a two-week period will reduce knee pain~     (Visual analogue scale, and Knee Osteoarthritis Outcome Survey).~   "
246167|NCT00331097|"~     The purpose of this study is to compare disease free survival of elderly breast cancer~     patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant~     chemotherapy (weekly docetaxel).~   "
246168|NCT00331084|"~     efficacy of antibiotic steroid combination compared with individual administration in~     prevention of postoperative inflammation in patients having cataract surgery~   "
246169|NCT00331071|"~     The purpose of the study is to assess the occurrence of venous thromboembolism (blood clots),~     stroke, and heart attack in current users of ORTHO EVRA compared to current users of~     norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol with special~     attention to duration of use. The study uses data from the PharMetrics Patient-Centric~     Database and MarketScan database, which are US medical claims databases.~   "
246170|NCT00331058|"~     The primary goal of this study is to compare the expression of key GSK drug targets across~     the 4 asthma phenotypes and healthy subjects and secondarily to evaluate changes in target~     expression in response to a 2-week course of corticosteroids across the 4 asthma phenotypes.~     Each asthmatic subject in this study will undergo two bronchoscopies. Each healthy subject~     will undergo one bronchoscopy.~   "
246171|NCT00331045|"~     This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day~     (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in~     patients who receive opioids for the management of cancer pain and develop constipation, by~     giving overall consideration to the efficacy and safety data in each treatment group. Also,~     efficacy and safety data of alvimopan in the recommended dose group will be compared with~     those of placebo and to confirm alvimopan's safety and efficacy.~   "
246172|NCT00331032|"~     The purpose of this study is to test the safety and tolerability of a medication applied~     vaginally twice daily in females versus placebo (inactive substance). Study participants will~     include 60 women, ages 18-24, non-pregnant, previously sexually active, Human~     Immunodeficiency Virus (HIV) negative and sexually transmitted infection (STI) free, in San~     Francisco or Kisuma, Kenya. Each study participant will be followed for 14 days of product~     use and an additional 7 days for safety assessments. Study procedures will include a physical~     exam with a pap smear, urine testing, blood sample testing, and a colposcopy (exam of the~     vagina and cervix using a lighted magnifying instrument). Information learned from this study~     may help to develop a safe and effective medication that could prevent herpes simplex virus~     and HIV. Participants may be involved in study related procedures for up to 55 days.~   "
246173|NCT00331019|"~     The purpose of this study is to determine whether a rapid bedside diagnosis of Group B Strep~     growing in the vagina and rectum can be performed with similar success to the routine~     culture.~   "
246223|NCT00330369|"~     This is a research study of a new experimental drug called darusentan. Darusentan is not~     currently approved by the U.S. Food and Drug Administration (FDA) for use in the United~     States, which means that a doctor cannot prescribe this drug. The purpose of this study is to~     determine if darusentan is effective in reducing systolic blood pressure in subjects with~     resistant systolic hypertension, despite treatment with full doses of three or more~     antihypertensive drugs, including a diuretic.~   "
246174|NCT00331006|"~     Hemophilia A is a serious blood clotting disorder caused by a lack of factor VIII, a~     specialized protein needed for normal blood clotting to occur. Individuals with this disease~     may experience spontaneous bleeding, pain and swelling in their joints due to excess~     bleeding, and bruising. A common treatment for severe hemophilia A is to intravenously~     replace the deficient blood clotting factor; however, some individuals may develop antibodies~     to this replacement factor. This study will evaluate the effectiveness of rituximab at~     reducing the antibodies that develop in response to the replacement factor in individuals~     with severe hemophilia A.~   "
246175|NCT00330993|"~     HYPOTHESIS: For women with pregnancies at <49, 50-56, and 57-63 days gestation who receive~     mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete~     abortion rate 24 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within~     each gestational age group.~      This is a prospective clinical trial. Women will be enrolled such that 40 women are in each~     of three gestational age ranges: ≤49, 50-56, and 57-63 days gestation on the day treatment is~     initiated. Once a gestational age range includes 40 subjects, enrollment in that group will~     be closed. Subjects will swallow mifepristone 200 mg and then place four 200 µg misoprostol~     tablets between the check and gum (2 tablets on each side). The women will be instructed to~     keep the tablets in place for 30 minutes; any remaining portions of the tablets will be~     swallowed after this time. Participants will follow-up 24 hours after receiving the~     misoprostol. Vaginal ultrasonography will be performed to assess for expulsion of the~     gestational sac. Women who have not aborted by the first follow-up visit will be given a dose~     of vaginal misoprostol and will return for a follow-up visit in one week. Subjects who have~     not aborted by the two-week follow-up will be offered a surgical abortion. At each visit,~     data will be collected on bleeding, cramping, other side effects, and medication use.~   "
246176|NCT00330980|"~     Statins are cholesterol-lowering medications that are often prescribed for individuals with~     high cholesterol and who are at risk for heart disease. Preliminary research has shown that~     statins may have other effects on the body that are unrelated to the heart. The purpose of~     this study is to evaluate the impact of statins on mood, mental processes, aggression, and~     serotonin levels.~   "
246177|NCT00330967|"~     The Objectives of the study are to: (1)compare the inflammatory response and insulin~     resistance in skeletal muscles during a systemic infusion of lipid with that during a local~     infusion of lipid into the femoral artery. which would cause minimal or no systemic~     hyperlipidemia but local plasma free fatty acid (FFA) concentrations similar to those during~     the systemic lipid infusion, and (2) determine the inflammatory response and insulin~     resistance in skeletal muscle during an infusion of lipid into the femoral artery as~     described above after NF-KB inhibition by high dose salicylate treatment in humans.~   "
246178|NCT00330954|"~     One of the goals of the Kansas City Diabetes Consortium is to identify and characterize genes~     and their products that are associated with T1DM. Characterization of such genes and their~     products can aid in developing new tools for risk assessment, development of new prevention~     strategies and monitoring progression of disease.~      Study design: Descriptive, basic science pilot study. The results of this pilot study will be~     used to help design a much larger study to address the importance of viral response and~     autoimmune diabetes.~   "
246179|NCT00330941|"~     Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed~     return of bowel function. The investigators therefore tested the hypothesis that including~     perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens~     the duration of hospitalization.~      Methods: Forty patients scheduled for laparoscopic colectomy were randomly allocated to~     receive intravenous lidocaine (bolus injection of 1.5 mg.kg-1 lidocaine at induction of~     anesthesia, then a continuous infusion of 2 mg.kg-1.h-1 intraoperatively and 1.33 mg.kg-1.h-1~     for 24 h postoperatively) or an equal volume of saline. All patients received similar~     intensive postoperative rehabilitation. Postoperative pain scores, opioid consumption, and~     fatigue scores were measured. Times to first flatus, defecation, and hospital discharge were~     recorded. Postoperative endocrine (cortisol and catecholamines) and metabolic (leucocytes,~     C-reactive protein, and glucose) responses were measured for 48 h. Data (median [25%-75%~     interquartile range] Saline vs Lidocaine groups) were analyzed using Mann-Whitney tests.~     P<0.05 was considered statistically significant.~   "
246180|NCT00330928|"~     The purpose of this study is to evaluate a near-infrared (NIR) spectroscopy system that has~     been designed to identify the chemical composition of coronary artery plaques in patients~     undergoing a percutaneous coronary intervention (PCI).~   "
246181|NCT00330915|"~     The purpose of this study is to help answer the following research questions:~      If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological~     parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed;~     To evaluate adverse events~   "
246182|NCT00330902|"~     In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose~     parasitaemia persists at very low levels throughout the dry season, could be a useful~     strategy for malaria control in areas with a short transmission season. We did a randomized~     trial to compare two regimens for clearance of low level parasitaemia in the dry season.~   "
246183|NCT00330889|"~     This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of~     Prednisolone on Rheumatoid Arthritis (RA) patients.~   "
246184|NCT00330876|"~     This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with~     hypercholesterolemia or combined dyslipidemia.~   "
246185|NCT00330863|"~     This study is designed to find out whether taking antipsychotic medication once every two~     weeks by injection compared to taking daily oral medication will help people with~     schizophrenia maintain better control of their symptoms.~   "
246186|NCT00330850|"~     The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating~     subjects suffering moderate pain form a migraine attack, with or without aura. The study is~     also intended to show the effectiveness of PRO-513 for associated symptoms of nausea,~     photophobia, and phonophobia due to a migraine attack.~   "
246256|NCT00329901|"~     Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and~     Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years~   "
246993|NCT00320060|"~     The primary objective of the study is to evaluate the safety and tolerability of Pyridorin~     (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic~     kidney disease.~   "
246187|NCT00330837|"~     Inadvertent puncture of an unintended object in a vascular access procedure is common and can~     lead to serious consequences. Inadvertent common carotid artery (CCA) puncture while~     targeting the internal jugular vein (IJV), for example, is reported to have an incidence of~     2% - 8% and usually results in localized hematoma formation. The hematoma may enlarge rapidly~     if the patient is coagulopathic, or if a large puncture wound is produced by the introduction~     of the sheath itself into the CCA. Airway obstruction, pseudoaneurysm, arterio-venous fistula~     formation and retrograde aortic dissection have all been reported as a consequence of CCA~     puncture. In the presence of occlusive (atheromatous) carotid disease, inadvertent puncture~     may carry the risk of precipitating a cerebrovascular accident.~      In this study, we aim to collect color Doppler and B-mode ultrasound videos from the most~     common ultrasound-guided vascular access sites - internal jugular vein, subclavian vein,~     femoral vein, basilic vein, and brachial vein. The videos will also include structures in~     close proximity to the intended veins. Using such database, we will run various vessel~     tracking and identification algorithms to evaluate their performance. Our ultimate goal is to~     develop an algorithm that will aid the ultrasound operator in identifying structures and~     differentiating between arteries and veins.~   "
246188|NCT00330824|"~     Efficacy/Safety of antibiotic steroid combination compared with individual administration in~     inflammation Post-LASIK~   "
246189|NCT00330811|"~     B-type Natriuretic Peptide (BNP) is a hormone that is made by the pumping chambers of the~     heart. The BNP level can be measured by a blood test and is used as a marker for heart~     problems in adults. Deciding if a child has a heart problem or a lung problem can be very~     difficult, especially in infants. Several studies have demonstrated that BNP levels are~     elevated when children have heart disease.~      The overall goal of the study is to be able to prove that obtaining BNP levels in pediatric~     patients can be used to identify heart problems. We already know that kids with heart~     problems have high BNP levels (>200pg/ml). We need to prove that children who come to the~     Emergency Department for non-cardiac problems still have normal BNP levels (<100pg/ml,~     slightly higher in the newborn population). This will be done by comparing BNP levels with~     the final diagnosis made by the ED physician.~   "
246190|NCT00330798|"~     The purpose of this study is to compare healing times and subjective pain level responses of~     nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.~   "
246191|NCT00330785|"~     To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage~     of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their~     governing guidelines.~   "
246192|NCT00330772|"~     Main Research Question(s):~      What is the effect of continuing aspirin until the time of coronary artery bypass graft~     surgery and of adding clopidogrel to aspirin after coronary artery bypass graft surgery for~     preventing blockage of coronary grafts, heart attack, stroke, and death? To reliably answer~     this question requires a large randomised trial. Before applying for a major grant from the~     Canadian Institute for Health Research to do the large study we would like to perform a small~     pilot study of 150 patients to demonstrate that it is feasible to recruit patients and to use~     a new test called CT angiography to determine whether the bypass grafts are still working~     or have become blocked.~      (ii) Why is this research important? Coronary artery bypass surgery has made a very important~     contribution to improving the health and survival of patients with advanced coronary artery~     disease but still has many problems. One in 10 patients experiences a heart attack at the~     time of surgery, 1 in 20 experiences a heart attack, stroke, or death during hospitalization,~     and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery. Antiplatelet drugs~     such as aspirin and clopidogrel are effective for preventing heart attacks, strokes and~     deaths but aspirin is usually stopped before coronary artery bypass graft surgery because of~     concerns about increasing the risk of bleeding. The effectiveness of the combination of~     clopidogrel and aspirin after surgery has not been evaluated. Our pilot study will provide~     key information about feasibility that will help us to design and perform a large definitive~     study in the future.~      (iii) What is being studied? We will be looking at blood flow in bypass grafts as well as the~     occurrence of heart attack, stroke, and death. For safety we will be looking at bleeding,~     transfusion, and need for further surgery because of bleeding. We will also perform~     laboratory tests of platelet function to measure and compare the effect of the study~     treatments to prevent blood clots from forming.~   "
246193|NCT00330759|"~     The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid~     (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in~     subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)~   "
246194|NCT00330746|"~     The purpose of this study is to select the more promising method of combining cetuximab with~     gemcitabine for treating patients with advanced non small-cell lung cancer, who are not~     candidates for platinum based therapy.~   "
246195|NCT00330733|"~     The hypothesis is that salsalate therapy may be an effective and safe method to modulate~     inflammation in metabolically-critical tissues and thus reduce insulin resistance and its~     related complications.~      The objectives of the study are to (1) determine whether salsalate therapy improves insulin~     resistance in subjects with IGT and changes in glucose area under the curve following a~     standard oral glucose tolerance test (OGTT); (2) determine whether salsalate therapy reduces~     a) plasma levels of a variety of well established inflammatory proteins and b) mononuclear~     cell inflammatory activity to provide evidence of reduced systemic and tissue inflammation,~     respectively; and (3)also determine whether salsalate therapy improves parameters of~     cardiovascular disease risk, including features of metabolic syndrome (fasting glucose,~     triglycerides, HDL, and blood pressure) as well as endothelial dysfunction.~   "
246196|NCT00330720|"~     What to do after an elderly patient falls but is not seriously injured can be a very~     challenging decisions for the patient and the Emergency Physician. Unfortunately, homecare~     support is often unavailable for weeks. The patient and physician must then choose between~     discharge home without support, or hospitalization. An emergency response service (ERS)~     allows the patient to summon assistance from anywhere in their home, and may provide another~     option.~      Objectives: To see how an ERS affects patients’ anxiety, fear of falling, and use of the~     health-care system after discharge. We will study patients over 70 years of age who have~     fallen but do not need to be hospitalized. Our belief is that the ERS will improve patient~     anxiety, and may prevent return visits to the Emergency or episodes of prolonged~     immobilization after a fall.~      Methods: Patients agreeing to participate in the study will be assigned by chance to receive~     either current standard discharge care, or standard care plus the use of the emergency~     response system. Patients will be interviewed one month after discharge to compare the impact~     of the ERS. This study is a first step in deciding whether the ERS is a useful new~     technology.~   "
246197|NCT00330707|"~     To compare the toxicity and efficacy of the combination of BCG and interferon alpha to~     standard dose and low dose BCG alone in high risk superficial bladder cancer~   "
246198|NCT00330694|"~     In the course of their disease, most patients with Parkinson's Disease (PD) face mounting~     mobility deficits, including difficulties with walking, balance, posture and transfers. This~     frequently leads to (fear of) falls, injuries, loss of independence, and inactivity which~     causes social isolation and increases the risk of osteoporosis or cardiovascular disease.~     These mobility deficits are difficult to treat with drugs and neurosurgery. However,~     physiotherapy is deemed effective in improving mobility deficits in PD. Physiotherapy is~     widely prescribed for this purpose in the Netherlands. Yet, the efficiency of current usual~     care physiotherapy can be questioned, for two reasons. First, the referral process seems~     inadequate because patients are mainly referred by neurologists who often lack insight into~     the (im-)possibilities of physiotherapy for PD. Consequently, patients with a real need for~     physiotherapy are not always referred (undertreatment), whereas others without a real need~     are (overtreatment). Furthermore, most therapists treating PD patients are not specifically~     trained in treating these patients. This is not surprising because average therapists rarely~     treat more than two patients per year in their practice. Therefore, patients who are being~     referred probably receive suboptimal treatment.~      The objective of this study is to evaluate whether the efficiency of physiotherapeutic care~     for patients with Parkinson's disease can be improved, at a reduced cost, by targeting two~     key elements of the current care system: a) inadequate referral by neurologists; b)~     suboptimal treatment by physiotherapists. We expect that optimal referral combined with~     expert treatment will increase the efficiency, as reflected by increased health benefits for~     patients at equal or reduced costs'.~   "
246199|NCT00330681|"~     The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via~     intravenous drip once a day in patients with ALS based on the changes in the revised ALS~     functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind,~     placebo-controlled manner. And in addition, this study will be performed to examine the~     safety of MCI-186 to ALS patients.~   "
246200|NCT00330668|"~     This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect~     long term safety and efficacy data on the continued use of recombinant human insulin-like~     growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency~     (IGFD). The secondary objective is to use the data collected to learn more about the~     relationship of IGF-1 exposure to the promotion of normal growth and pubertal development.~   "
246201|NCT00330655|"~     We hypothesize that memantine may be a safe and effective treatment for moderate to severe~     binge eating disorder associated with obesity.~      During this 12-week, open-label, outpatient study, male and female subjects between the ages~     of 18 and 65 years who have moderate to severe binge eating disorder and are obese will be~     treated with open-label memantine. Following this 12-week treatment phase, subjects may be~     eligible to continue into an extension phase which will last an additional 12 weeks. During~     the extension phase subjects will continue open-label memantine treatment.~   "
246202|NCT00330642|"~     The purpose of this study is to determine whether a rapid bedside diagnosis of group B strep~     (GBS) growing in the vagina and rectum can be performed with similar success to the routine~     culture in women who are in labor.~   "
246203|NCT00330629|"~     We propose to add a treatment preference component to a larger study testing standard~     behavioral treatment (SBT) for weight loss without specific food group restriction vs~     standard behavioral treatment with gradual elimination of meat, poultry, and fish [a~     lacto-ovo-vegetarian (LOV) meal plan]. Eligible respondents will be randomized to one of two~     conditions: Treatment Preference-Yes/No. Individuals in the Treatment Preference-Yes will be~     assigned to their choice (SBT or SBT+LOV), those in Treatment Preference-No will be~     randomized to either SBT or SBT+LOV without regard to their preference.~   "
246204|NCT00330616|"~     This is a study to obtain clinical experience of 323U66 SR for elderly patients with~     depression in repeat-dose of 323U66 SR up to 300mg/day, and to conduct exploratory~     investigation on safety, efficacy and pharmacokinetics profile in elderly patients with~     depression.~   "
246205|NCT00330603|"~     This study will seek to determine the amount of acids a person with a chronic cough that is~     suspected to be related to acid reflux breathes out after coughing. The study will also seek~     to determine if this measurement can predict the best treatment for the cough.~      Subjects with a chronic cough which is suspected to be related to acid reflux for which their~     doctor has prescribed a proton pump inhibitor medication will be enrolled in this study.~   "
246206|NCT00330590|"~     The investigators have developed a new device for guiding invasive procedures with ultrasound~     (US), which they call the sonic flashlight (SF). They attach a half-silvered mirror and a~     small flat-panel monitor directly to an ultrasound transducer to project a virtual image of~     the US scan into its actual location within the patient. This permits the operator to guide a~     needle through the skin by aiming directly at the image, using natural hand-eye coordination~     rather than looking away from the patient at a conventional display. The device requires no~     tracking or head-mounted apparatus, and provides an intuitive merger of the visual exterior~     of the patient with an in situ ultrasound image, which can be simultaneously viewed by others~     assisting the operator. The investigators believe the SF will increase the accuracy, safety,~     and speed for a wide variety of invasive procedures, and will require less extensive training~     than conventional US displays.~      Given the wide variety of procedures for which the SF could be used, the investigators have~     narrowed their focus to applying it to a single application: vascular access. They have~     demonstrated clinically that the SF can be used successfully to guide the placement of the~     peripherally inserted central catheter (PICC) lines. The research proposed here will expand~     this application to include the insertion of other central venous access (CVA) lines through~     the internal jugular vein, subclavian vein, and femoral vein. The historical approach to CVA~     line placements has involved the physical exam and identification of visible landmarks. With~     the introduction and common usage of ultrasound, it has become routine to use ultrasound~     guidance.~      Much of the difficulty in learning conventional ultrasound (CUS) guided procedures stems from~     the displaced sense of hand-eye coordination that occurs when the operator looks away from~     the operating field to see the ultrasound display. The SF directly addresses many of these~     issues and therefore the investigators believe that it is well suited for this application.~     They have already shown that novice US users learn vascular access procedures in training~     phantoms more quickly using the SF than CUS. They have also shown that intravenous (IV) team~     nurses already proficient in CUS guided PICC lines perform vascular access in training~     phantoms more quickly using the SF than CUS guidance. Finally, as mentioned earlier, the~     investigators have shown that the SF can be used successfully to guide the placement of PICC~     lines. This study will test the hypothesis that the SF will successfully facilitate catheter~     placement in the subclavian, femoral, and internal jugular veins demonstrating equal~     vasculature visualization as conventional ultrasound.~   "
246207|NCT00330577|"~     The purpose of this study is to compare the short-term mean 24-hour intraocular pressure~     control, 24-hour blood pressure effect and safety of Latanoprost/Timolol fixed combination~     given once in the evening with placebo once in the morning versus timolol maleate 0.5% given~     twice daily in patients with ocular hypertension and primary open-angle glaucoma.~   "
246257|NCT00329888|"~     Compare endoscopic papillary balloon dilatation vs. endoscopic sphincterotomy for bile duct~     stones in:~        -  when sphincterotomy is difficult (periampullary diverticulum, prior sphincterotomy or~          Billroth II anastomosis)~        -  when there is distal CBD tapering.~   "
246208|NCT00330564|"~     The goal of this clinical research study is to learn if sunitinib malate (SU011248) can help~     to control VHL. The safety of this drug will also be studied.~      Primary objectives:~        -  Evaluate safety of treatment with SU011248/sunitinib malate (50 mg daily dose for 4~          weeks, then 2 weeks off) for 6 months in patients with Von Hippel-Lindau Syndrome (VHL)~          who have a measurable lesion undergoing surveillance~      Secondary objectives:~        -  Evaluate efficacy of treatment with SU011248/sunitinib malate (50 mg daily dose for 4~          weeks, then 2 weeks off) for 6 months in patients with VHL who have a measurable lesion~          undergoing surveillance~      Correlative objectives:~        -  Evaluate quality of life of SU011248/sunitinib malate therapy in VHL patients~        -  Evaluate peripheral blood lymphocyte receptor phosphorylation in VHL patients taking~          SU011248/sunitinib malate (optional procedure)~        -  Correlate results of dynamic contrast-enhanced and diffusion weighted MRI and dynamic~          contrast enhanced CT with response and explore findings suggestive of surrogates of~          early response (optional procedure)~   "
246209|NCT00330551|"~     This study will determine the effectiveness of oral risperidone versus long-acting injectable~     risperidone in treating people with first-episode schizophrenia.~   "
246210|NCT00330538|"~     Hypothesis:~      Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as~     a part of the leukemia treatment protocol, will have an increased incidence and severity of~     osteoporosis.~   "
246211|NCT00330525|"~     Control of food intake, size and frequency of meals are critical to the development of~     obesity. The stomach signals feelings of fullness after a meal and therefore plays a role in~     control of calorie intake. It is unclear whether the approved appetite reducing drug~     sibutramine changes the function of the stomach. Differences in the way individuals respond~     to treatment with the appetite suppressant sibutramine may also explain why some people lose~     weight while others do not.~      This single center clinical study aims to compare functions of the stomach in healthy,~     overweight and obese individuals, and to evaluate the effects of the FDA-approved appetite~     suppressing medication sibutramine on weight loss and stomach functions in patients who are~     overweight or obese. The effect of individual differences in inherited genes on weight~     reduction with sibutramine will be tested.~   "
246212|NCT00330512|"~     About 20-25% of deliveries are by cesarean section. Most are elective with use of regional~     anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It~     have the risk of reduction of blood flow to the placenta and the fetus.~      No studies had followed the newborns their first days of live,of mothers who developed~     hypotension in durins CS.~   "
246213|NCT00330499|"~     The purpose of this study is to define the optimal management of localised transitional cell~     carcinoma (TCC) of the urinary bladder. The main objective is to evaluate whether~     chemoradiation is superior to radiotherapy alone.~   "
246214|NCT00330486|"~     The purpose of this study is to determine whether acamprosate (Campral) is safe and effective~     in treating alcohol dependence in individuals with bipolar disorder. All subjects in the~     study must be currently stabilized on mood-stabilizing medication. Half of the subjects will~     receive acamprosate in addition to their mood-stabilizing medication; control subjects will~     be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as~     mood stability will be obtained weekly throughout the active phase of the study.~   "
246215|NCT00330473|"~     A study to compare insulin use and its effect on glucose control and other outcomes in~     patients with Type 2 diabetes who together with their healthcare provider manage their~     disease by discussing and agreeing on the diabetes treatment chosen from a selection of~     available treatment options.~   "
246216|NCT00330460|"~     The purpose of this study is to determine whether in postmenopausal women with low bone~     mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is~     not less than that observed in subjects receiving alendronate sodium by more than a~     pre-specified non-inferiority margin.~   "
246217|NCT00330447|"~     The researchers aim to investigate the outcome (overall survival) of mothers who are~     diagnosed and/or treated for cancer during pregnancy. Furthermore they want to test the~     hypothesis that children who were exposed to cancer or cancer treatment (cytotoxic drugs,~     radiation therapy, targeted therapy,...) develop normally (neurologic and cardiologic~     examination).~   "
246218|NCT00330434|"~     The two purposes of this study are~        1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages~          has~             1. on the blood level of bupropion and chlorzoxazone and their major breakdown~               products in the blood and~             2. on the stimulant effect of bupropion and~        2. to determine what effect a normal and common (25% frequency) genetic variation of a~          specific liver enzyme (that breaks down bupropion) has~             1. on the blood levels of bupropion and its major breakdown products in the blood and~             2. on the stimulant effect of bupropion.~      Two groups of volunteers will be recruited for this study:~        1. volunteers who drink moderate to heavy amounts of alcohol frequently and~        2. volunteers who usually do not drink alcohol.~      Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the~     study.~   "
246219|NCT00330421|"~     This phase II trial is studying how well sorafenib works in treating patients with soft~     tissue sarcoma. Sorafenib may stop the growth of soft tissue sarcoma by blocking blood flow~     to the tumor and blocking some of the enzymes needed for tumor cell growth~   "
246220|NCT00330408|"~     This study aims to assess the impact of training General Practitioners (GPs) on adherence to~     antihypertensive medication among hypertensive individuals. It also aims to assess risk~     factors for non-adherence. Special training (in appropriate algorithms for management and~     patient involvement in therapeutic decision making) has been given to GPs. The study has been~     conducted in six middle or low income clusters of Karachi recruiting individuals randomized~     to specially trained or untrained GPs, with a follow-up period of 6 weeks. The medication~     event monitoring system (MEMS)has been used for assessing adherence. It is hypothesized that~     compliance levels of individuals going to specially trained GPs is higher compared to those~     going to GPs not having received special training.~   "
246221|NCT00330395|"~     The purpose of this study is to test the amount of caspofungin found in the blood of neonate~     and infants <3 months of age following treatment with caspofungin at 25 mg/m2. Another~     purpose is to test the safety of caspofungin in treating neonates and infants with Candida~     infections (a certain type of fungal infection).~   "
246224|NCT00330356|"~     High blood pressure is a global public health problem in developed and developing countries~     including Pakistan. Various studies conducted around the world have linked salt intake to~     variation in the blood pressure.However, definite conclusions are lacking and the exact role~     of dietary salt in salt-blood pressure relationship remains controversial.~      While clinical practice guidelines recommend dietary salt restriction for lowering blood~     pressure, the relationship of salt with blood pressure has not been tested in the Pakistani~     population. Therefore, the efficacy of dietary salt restriction on blood pressure of this~     population remains to be determined. The study aims to determine the relationship between~     dietary salt intake and blood pressure in Pakistani population. It is hypothesized that~     alteration in the dietary salt intake demonstrates significant changes in the Systolic BP.~   "
246225|NCT00330343|"~     This is an investigator initiated dose finding study designed to determine the optimal dose~     of naloxone to prevent or minimize the most common side effects induced by opioids, namely~     itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the~     Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute,~     moderate to severe pain, and who are to be treated with intravenous Patient controlled~     analgesia (IVPCA) morphine will be eligible for inclusion in this study. Patients will be~     recruited by a study investigator prior to the initiation of IVPCA therapy. The majority of~     patients will be post operative patients, and will start therapy and the investigational drug~     in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit. The investigators plan~     on studying between 10 and 99, male and female patients over a 2 year period.~   "
246226|NCT00330330|"~     The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five~     ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics.~   "
246227|NCT00330317|"~     The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy~     with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive~     primary breast cancer on tumour regression to permit breast conserving surgery.~   "
246228|NCT00330304|"~     The study involves use of isoniazid and cotrimoxazole as strategies for preventing infections~     in HIV-infected children and reducing mortality. Cotrimoxazole is well known to reduce~     mortality and infections in HIV-infected children and is currently the recommended standard~     of care. However, isoniazid has only been studied in HIV-infected adults (in whom it has been~     shown to substantially reduce the incidence of tuberculosis). In a randomised controlled~     study of isoniazid in HIV-infected children, the investigators found that INH reduced~     mortality and tuberculosis incidence in excess of 50%; the data safety monitoring board~     recommended termination of the placebo arm given the beneficial effects of INH. The~     investigators therefore aim to follow-up these children to compare the long term impact of~     two different INH and CTX preventive regimens (daily versus thrice weekly) on morbidity,~     mortality, adherence and incidence of adverse reactions. The investigators also aim to~     investigate the efficacy, safety and tolerability of INH compared with placebo for prevention~     of TB in children receiving HAART as the benefit in this group is unknown.~   "
246229|NCT00330291|"~     Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep~     efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy~     (sleep attacks). It has been shown to be a safe and effective agent here where deep,~     restorative slow wave sleep improves and next day cataplexy attacks tend not to occur.~      Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed~     or been involved in a traumatic event. After the event is over, nightmares, flashbacks,~     avoidance of people and places associated with trauma and hyperarousal occur which is~     incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with~     multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI~     serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to~     degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to~     remit as they continue to have sleep problems. PTSD patients will often fail to respond to~     antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents~     (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem's~     ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia~     due to PTSD.~      The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed~     usual PTSD treatments and have failed usual insomnia treatments in particular will be given~     Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is~     a safe treatment optionin this difficult-to-treat patient population.~   "
246230|NCT00330278|"~     This is a randomized, double-blinded placebo controlled trial of cefazolin timing before~     cesarean section fo infection prophylaxis. Subjects are randomized to cefazolin either 30~     minutes prior to skin incision or at time of cord-clamping. Primary outcome is infectious~     morbidity including wound infections and endometritis.~   "
246231|NCT00330265|"~     The objective of this study is to determine the safety and effectiveness of a device (the~     KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as~     compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2~     diabetes mellitus.~      This is a prospective, randomized, multi-center, unmasked, controlled study. All patients~     will receive care for the diabetic foot ulcer during the study.~      Participation in the study is for 24 weeks.~   "
246232|NCT00330252|"~     The purpose of this study is to determine whether the combination of alemtuzumab and~     rituximab is safe and effective in treating patients with relapsed Chronic Lymphocytic~     Leukemia (CLL) and to determine whether alemtuzumab can be given as a single weekly~     subcutaneous dose, together with rituximab.~   "
246258|NCT00329862|"~     Laparoscopic Adjustable Gastric Banding (LAGB) is a gold standard in the surgical treatment~     of morbid obesity. We hypothesize that the addition of truncal vagotomy (cutting of nerves to~     the stomach) will produce greater weight loss and better reduction of co-morbidities~     (diseases caused by or aggravated by morbid obesity) than LAGB alone. 25 patients will be~     enrolled and outcomes compared to LAGB historical controls over a post-operative period of 24~     months.~   "
246259|NCT00329849|"~     Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in~     children 2 to 10 years of age~   "
246994|NCT00320047|"~     This study will evaluate the effectiveness of the drug baclofen in reducing binge eating and~     associated food cravings in people with bulimia nervosa or binge eating disorder.~   "
246233|NCT00330239|"~     Pharmacotherapy has demonstrated efficacy in a number of controlled trials in the treatment~     of PTSD. The selective serotonin reuptake inhibitors have proven particularly useful in~     treating this disorder. Currently there are two selective serotonin reuptake inhibitors~     (Zoloft® and Paxil®), that have been FDA approved for treating PTSD. Coincidentally, this~     same class of medications has also been shown to have efficacy in some trials in decreasing~     alcohol consumption in heavy drinkers. The goal of the proposed study is to preliminarily~     investigate the efficacy of Paxil® (paroxetine), in decreasing symptoms of PTSD as well as~     decreasing substance use, in individuals with concurrent substance dependence and PTSD. The~     type of paroxetine used in this trial will be Paxil CR®, which is a sustained release~     formulation of paroxetine, which has fewer side effects and greater tolerability. This is a~     particularly important issue in substance using populations because medication compliance is~     generally poor.~      Two specific hypotheses will be tested. 1) Individuals who receive Paxil CR® will have a~     greater improvement in their PTSD symptoms (based on CAPS-2 and CGI) than those who receive~     placebo. 2) Individuals who receive Paxil CR® will have greater improvement in their~     substance use outcomes (based on UDS and TLFB) than will those who receive placebo.~   "
246234|NCT00330226|"~     The purpose of this study is to investigate the efficacy and safety of long-term~     psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and~     side effects.~   "
246235|NCT00330213|"~     Red wine consumption is associated with reduced cardiovascular disease mortality, and the~     cardioprotective properties may be partly related to its ability to improve endothelial~     function. The purpose of this study was to determine whether moderate doses of red wine,~     de-alcoholized red wine and cognac improve coronary flow reserve.~   "
246236|NCT00330200|"~     The aim of this study is to examine the effects of ISIS 113715 monotherapy on insulin~     sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2~     diabetes mellitus.~   "
246237|NCT00330187|"~     In the current proposal, we intend to study the efficacy of bupropion SR with or without~     combined contingency management (CM) among adolescent cigarette smokers. The proposed study~     will test not only medication (bupropion SR), but also combination of medication and CM in~     potentially improving smoking cessation outcomes AND retention of adolescent smokers in the~     study.~      Hypothesis to be tested: Bupropion SR treatment will increase abstinence from cigarette~     smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as~     compared to treatment with placebo only.~      Hypothesis to be tested: Adolescent smokers treated with combined bupropion SR + contingency~     management (CM) treatment will have increased retention and increased abstinence rates when~     compared to bupropion SR alone or CM + placebo treated groups (as measured by decreased~     drop-out of participants, urine cotinine and continuous abstinence).~      Hypothesis to be tested: CM will increase the abstinence from cigarette smoking (as measured~     by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment~     with placebo only.~   "
246238|NCT00330174|"~     STUDY OBJECTIVES:~      The primary objective of this study is to compare the safety and efficacy of acamprosate~     versus placebo in the treatment of alcohol dependence in adults with co-occurring mood or~     anxiety disorders (specifically, depression (MDE), generalized anxiety disorder (GAD) or~     social anxiety disorder). Secondary objectives are to evaluate the effect of acamprosate~     treatment on mood and anxiety disorders.~      STUDY DESIGN:~      This is a randomized, double-blind, placebo-controlled trial evaluating acamprosate in the~     treatment of alcohol dependence in adult outpatients with concurrent mood and/or anxiety~     disorders. The active study phase will be 12 weeks in duration. There will be a two-week~     screening period, followed by 12 weeks of study medication and a follow-up assessment at 14~     weeks from randomization.~      STUDY POPULATION:~      A total of 90 (30 per site) men and women aged 18-60 years who have a current diagnosis of~     alcohol dependence as well as a current DSM-IV diagnosis of either MDE, GAD and/or social~     anxiety will be recruited to participate in this study. Only those individuals whose~     psychiatric disorders are stable will be randomized to acamprosate or placebo. Three sites~     will participate in this trial.~      TREATMENTS:~      Eligible participants will be randomly assigned to receive either acamprosate or matching~     placebo for 12 weeks.~      EFFICACY ASSESSEMENTS:~      The primary efficacy outcome measure will be cumulative days abstinent as measured by~     self-report.~   "
246239|NCT00330161|"~     This phase II trial is studying how well vorinostat works in treating patients with~     progressive metastatic prostate cancer. Drugs used in chemotherapy, such as vorinostat, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
246240|NCT00330148|"~     The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on~     two molecules officially registered: melarsoprol, the most commonly used, has a poor safety~     profile and is becoming ineffective due to parasite resistance; and eflornithine, with better~     tolerance but more complicated and expensive to implement in endemic countries. nifurtimox,~     registered only for Chagas' disease but used off-label since the 1970’s in series of cases of~     HAT, is at present the only other available alternative.~      The very limited number of compounds available, the lack of prospects for the development of~     new products and the emergence of resistance are arguments for the use of therapeutic~     combinations.~      This study evaluates the efficacy and safety of three drug combination therapies:~     melarsoprol-nifurtimox, melarsoprol-eflornithine and eflornithine-nifurtimox.~   "
246241|NCT00330135|"~     To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium~     hyaluronate and placebo following an intra-articular injection in patients with symptomatic~     osteoarthritis of the hip.~      Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic~     hip and will be followed up for three months.~      At the third month, if the score for overall pain is still > 40 mm on the VAS, a second~     injection of ADANT® can be given irrespective of which treatment was received previously. The~     patient will be followed up for a further 3 months in an open-label fashion (monthly visits).~   "
246242|NCT00330122|"~     The fractures of the wrist, affecting the distal end of the radius are frequent, in~     particular in the old subject and/or osteoporotic. Beside the simple fractures treated by~     mini-invasive surgical methods, there is a considerable number of strong comminuted fractures~     for which no method of osteosynthesis proves completely satisfactory, especially on~     osteoporotic bone. However, the restitution of the anatomy remains the principal concern of~     the surgeon eager to ensure a good functional result to its patient, with the proviso that~     the least aggressive possible method is used.~      Until now, it is of use to rather largely use the external fixer bridging the radiocarpal~     articulation to maintain the length of the radius, more or less associated with an another~     method of internal osteosynthesis with minima. The major disadvantage of this kind of~     assembly is the high rate of neuroalgodystrophic syndromes of the wrist and losses of~     reduction, sometimes generators of painful after-effects and serious stiffening. These~     after-effects which are sometimes definitive can be very disabling when they occur among~     active people, a fortiori when they touch the dominant side.~      The recent alternative to the use of the external fixer is the use of the plates with locking~     screws, affixed on the foreface of the radius, maintaining the length of the radius but not~     bridging the articulation. Thus, this kind of osteosynthesis does not generate ligamentary~     distraction nor of the radiocarpal capsule, factors which would be prevalent in the release~     of the algodystrophy and of the stiffening. On the other hand, this method of osteosynthesis~     is more invasive than the installation of an external fixer, because it requires the access~     of the foreface of the radius and cannot be practised in a percutaneous way. At present,~     there is any randomized comparative study, the published studies being only comparative~     retrospective and not controlled, carried out on nonhomogeneous series of fractures.~      The principal objective of our study is to evaluate the interest of the locking plates in the~     maintenance of the radial length in the comminuted fractures of the distal end of the radius.~      It is about a prospective, multicentric, randomized study in 2 parallel groups carried out~     patients from 40 to 80 years hospitalized in a service of Osseous Surgery.~      Patients: articular displaced fractures of the lower end of the radius with strong metaphysar~     comminution (groups M3 and M4 of the classification MEC) with an important shortening of the~     radius, measured by a radio-ulnar index higher than 4 mm compared to the opposite side. Are~     excluded the articular explosions type E4. The patients of more than 40 years, autonomous and~     active, able to give an assent for the participation in a clinical study are included.~      Treatment. The first group of patients would be treated by fore locked plate possibly~     associated with pins. The immobilization would be limited to a antibrachiopalmar splint for~     45 days. If, peroperatively, a sufficient stability of the fracture cannot be obtained by the~     plate alone, and that a complementary stabilization by fixer proves to be necessary, then the~     case will be entered like a failure of stabilization by locked plate.~      The second group of patients would be treated by external radiocarpal fixer in neutralization~     possibly associated with an internal osteosynthesis with minima (percutaneous pins). The~     fixer would be left in place during 45 days.~      The reeducation would consist in the 2 groups of an active mobilization of the fingers at the~     beginning, then of an active reeducation of the wrist in flexion/extension and~     pronosupination starting from the 45th day.~      About fifty patients should be included in each group, with a collection of the clinical and~     radiographic results at 21 days, 45 days, 3 months and 6 months.~   "
246274|NCT00329654|"~     This will be a prospective, randomized, single blinded, controlled study in a single center~     setting to assess the effect of either phototherapy with the Embar® light therapy or sham~     irradiation.~   "
246243|NCT00330109|"~     Gliomas are one of the most challenging tumors to treat, because areas of the apparently~     normal brain contain microscopic deposits of glioma cells; indeed, these occult cells are~     known to infiltrate several centimeters beyond the clinically apparent lesion visualized on~     standard computer tomography or magnetic resonance imaging (MR). Since it is not feasible to~     remove or radiate large volumes of the brain, it is important to target only the visible~     tumor and the infiltrated regions of the brain. However, due to the limited ability to detect~     occult glioma cells, clinicians currently add a uniform margin of 2 cm or more beyond the~     visible abnormality, and irradiate that volume. Evidence, however, suggests that glioma~     growth is not uniform - growth is favored in certain directions and impeded in others. This~     means it is important to determine, for each patient, which areas are at high risk of~     harboring occult cells. We propose to address this task by learning how gliomas grown, by~     applying Machine Learning algorithms to a database of images (obtained using various advanced~     imaging technologies: MRI, MRS, DTI, and MET-PET) from previous glioma patients. Advances~     will directly translate to improvements for patients.~   "
246244|NCT00330096|"~     Fruits and vegetables are rich in a variety of flavonoids with antioxidant properties. These~     compounds may be partially responsible for some of the positive links found between fruits~     and vegetables intake and higher bone mineral density in adults and children. Several animal~     studies have shown that consumption of onions (which are rich in quercetin), rutin (a~     quercetin glycoside) and resvatrol (found in red wine) inhibits ovariectomy induced bone loss~     in rats. One of the most studied flavonoids with respect to bone health is the soy~     isoflavones. However, consumption of soy products is relatively low in Western countries. One~     the other hand, a flavonoid such as hesperidin, found mostly in oranges is much more abundant~     in the Western diet. Citrus juice consumption has been demonstrated to prevent bone loss in~     male orchidectomized rats while specifically feeding hesperidin has been shown to prevent~     bone loss in ovariectomized mice and rats. However, to date no clinical prove has been~     obtained for these benefits.Therefore the aim of this study is to investigate the effect of~     hesperidin in preventing bone loss in postmenopausal women. This study is designed as a~     2-year, double blind, placebo-controlled, two arm, and parallel group study. The primary~     outcome measure is change in bone mineral density (BMD) while the secondary outcome measures~     are changes in bone resorption and formation markers as well as body composition. The women~     are randomised to consume 2 servings of hesperidin-rich food or food without hesperidin but~     with the same taste & appearance (placebo). Subjects will undergo medical screening,~     anthropometry, physical activity, dietary assessments and BMD before randomisation into~     placebo or active group. Follow-up measurements are made at 3-month intervals (for blood and~     urine collection) and 6-month intervals for bone mineral density. Side effects are also being~     monitored during each visit.~   "
246245|NCT00330083|"~     This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults~   "
246246|NCT00330070|"~     The purpose of the study is to determine whether IPL512,602 is safe and effective for the~     treatment of asthma symptoms in patients who remain symptomatic on a background therapy of~     inhaled corticosteroids.~   "
246247|NCT00330044|"~     To determine the safety of Alimta when used with chemoradiation in inoperable non small cell~     lung cancer~   "
246248|NCT00330018|"~     The rationale for this protocol is based on the need to assess if the current post stem cell~     transplantation CMV prophylaxis strategies (e.g. high-dose acyclovir plus pre-emptive~     treatment) can be improved by the use of valganciclovir. CMV is the most common viral~     infection following stem cell transplantation, causing significant morbidity and mortality.~     Furthermore, CMV has been shown to be associated with a number of indirect effects in SCT~     recipients including allograft dysfunction, acute and chronic graft versus host disease~     (GVHD). Valganciclovir is shown to be more active than oral ganciclovir, and as good as~     intravenous (i.v.) ganciclovir in treating newly diagnosed CMV retinitis. The use of~     valganciclovir for CMV prophylaxis post stem cell transplantation was never tested in~     controlled study. The investigators therefore suggest a prospective, randomized study to~     evaluate the efficacy and safety of valganciclovir compared with acyclovir for prevention of~     CMV disease in allogeneic stem cell transplantation recipients.~   "
246249|NCT00330005|"~     The purpose of this study was to compare a group psychotherapy intervention, the Integrative~     Outpatient Model, to a convenience control, in adults with bipolar disorder.~   "
246250|NCT00329992|"~     Participants are randomly assigned to either 16 sessions of Brief Eclectic Psychotherapy~     (Gersons et al. (2000) Journal Trauma Stress 13: 333-348), comprising psychoeducation,~     exposure, mementos and writing assignments, domain of meaning and integration, farewell~     ritual, or a minimal attention control group that will be offered 16 sessions of BEP after a~     waiting time of four months. Participants in the minimal attention control group receive~     monthly telephone calls and complete a symptom self monitoring diary (Tarrier, N. et al.~     (1999) Behavior Therapy 30: 597-605) for three weeks.~   "
246251|NCT00329979|"~     Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain~     injury could occur at an unexpectedly high rate. One study has found that up to 22% of~     patients with severe aortic stenosis who have undergone retrograde catheterization of the~     valve can be identified as having new ischemic lesions as detected by diffusion-weighted (DW)~     magnetic resonance imaging (MRI). During cardiac catheterization, cerebral microembolism as~     detected by TCD has frequently been observed, but whether it is clinically relevant remains~     unknown . However, recent studies have suggested that some of these microemboli could be~     responsible for acute brain injury, as documented by DW MRI.~      Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved~     estimate of cerebral ischemic events associated with cardiovascular-catheter procedures. We~     therefore decided to perform DW MRI before and after cardiac catheterization to prospectively~     assess both clinically silent and apparent cerebral embolisms for the first time in a~     multicenter trial. Furthermore, a randomization between radial and femoral access will allow~     assessment of risk of silent brain injury associated with the different vascular access~     sites.~   "
246252|NCT00329966|"~     To evaluate the antibody response to each influenza vaccine antigen when administering a~     single dose to subjects aged 18 years and over~   "
246253|NCT00329940|"~     The purpose of this study is to assess rheumatologic tolerability of letrozole in~     postmenopausal patients with hormone receptor positive breast cancer having discontinued~     anastrozole adjuvant treatment due to musculoskeletal disorders.~   "
246254|NCT00329927|"~     To evaluate the antibody response to each influenza vaccine antigen when administering a~     single dose to subjects aged 65 years and over~   "
246255|NCT00329914|"~     The purpose of the study is to determine whether a daily dose of 200 mg progesterone~     administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm~     delivery amongst twin pregnancies.~   "
246260|NCT00329836|"~     This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous~     allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli~     (e.g. light touch) are applied to the skin. Many studies have been performed looking at the~     presence of cutaneous allodynia in patients with migraines; however, few studies have~     examined it in cluster headache patients. There is still much to be learned about the brain~     and how it functions if the investigators are to understand the underlying causes of cluster~     headache. It is important to explore cutaneous allodynia in cluster headache as it may help~     guide physicians with the care of these individuals. Sixty patients will be screened for this~     study. Thomas Jefferson University is the only center enrolling patients in this research~     study.~   "
246261|NCT00329823|"~     The rationale of the protocol is based on the reported beneficiary results of case-patients~     by the administration of other anti-TNF drug (infliximab) in separate cases on the grounds of~     a probable autoimmune predisposition of the disease. The objective of this study is to~     clarify the potency of etanercept for the therapy of hidradenitis suppurativa.~   "
246262|NCT00329810|"~     To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic~     patients.~   "
246263|NCT00329797|"~     RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing~     radiation therapy and hormone therapy. It is not yet known whether zoledronate is more~     effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in~     patients with prostate cancer.~      PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works~     compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in~     patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and~     hormone therapy.~   "
246264|NCT00329784|"~     This study will evaluate whether early exposure to peanuts promotes tolerance and provides~     protection from developing peanut allergy in children who are allergic to eggs or who have~     severe eczema.~      This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).~   "
246265|NCT00329771|"~     Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a~     heightened skin sensitivity during an active migraine attack. Migraine attacks in patients~     who experience allodynia are more difficult to treat. This study intends to collect and~     evaluate data on the phenomenon of allodynia in patients with episodic migraine during an~     actual attack. The results of this study may help clinicians better understand allodynia,~     thereby helping them diagnose and more effectively manage patients with migraine and~     allodynia.~   "
246266|NCT00329758|"~     The purpose of this study is to determine whether rosuvastatin is effective in the management~     of moderate head injury by improving amnesia and orientation.~   "
246267|NCT00329745|"~     This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine~     efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in~     infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following~     schedules:~      at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or~     rota-030.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
246268|NCT00329732|"~     Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of~     headache. The GONB procedure involves a series of injections into the greater occipital nerve~     (a spinal nerve located at the back of your head). The purpose of this study is to determine~     whether GONB is effective for the treatment of prolonged migraine attacks. This study is~     placebo controlled, which means that half of the patients participating will receive~     injections of active study drug (lidocaine plus bupivicaine) and half of the patients will~     receive injections of saline (placebo). The study is also blinded which means that neither~     you nor the study staff will know whether you received active study drug or placebo. The~     study remains blinded only for the first 30 minutes, at which point additional treatments~     (including GONB) can be administered at the discretion of your treating physician.~      40 patients are expected to participate in this research study. This study is being conducted~     at Thomas Jefferson University only.~   "
246269|NCT00329719|"~     This phase I/II trial studies the side effects and best dose of temsirolimus when given~     together with sorafenib tosylate and to see how well they work in treating patients with~     glioblastoma that has come back. Sorafenib tosylate may stop the growth of tumor cells by~     blocking blood flow to the tumor. Drugs used in chemotherapy, such as temsirolimus, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Sorafenib tosylate and temsirolimus may also stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving sorafenib tosylate with~     temsirolimus may kill more tumor cells.~   "
246270|NCT00329706|"~     A brain PET scan is recognized as reasonable and necessary for some patients with a~     recently established diagnosis of dementia (Centers for Medicare and Medicaid Services,~     Decision Memo CAG-00088R, 2004), but evidence is less clear for patients having less severe~     cognitive problems. A substantial portion of such patients will develop Alzheimer's disease~     and other forms of dementia, which affect millions of people in the U.S., costing us over~     $100 billion annually. This project employs a prospective randomized protocol to determine~     whether PET scanning can help distinguish those patients with early Alzheimer's changes in~     their brains from those having other causes of cognitive impairment more accurately than is~     done with current clinical practices alone, and lead to earlier, more effective therapies~     which extend patients' abilities to think and function independently.~   "
246271|NCT00329693|"~     Women included in this study are undergoing controlled ovarian hyperstimulation for assisted~     reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.~   "
246272|NCT00329680|"~     The scope of this clinical study is to evaluate the possible role of an enteral formulation~     enriched with EPA, GLA and Antioxidants in patients diagnosed in the early stages of sepsis~     despite mechanical ventilation requirements, as well as the impact of this diet upon glycemic~     control and its capacity to prevent the development of sepsis into severe sepsis and septic~     shock.~   "
246273|NCT00329667|"~     This study is a multi-center, prospective, non-randomized, observational study. The~     objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic~     valve.~   "
246275|NCT00329641|"~     This phase II trial is studying how well sorafenib works when given together with carboplatin~     and paclitaxel in treating patients with stage IV melanoma of the eye. Drugs used in~     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may~     help carboplatin and paclitaxel work better by making tumor cells more sensitive to the~     drugs. Sorafenib may also stop the growth of melanoma by blocking some of the enzymes needed~     for tumor cell growth and by blocking blood flow to the tumor. Giving sorafenib together with~     carboplatin and paclitaxel may kill more tumor cells.~   "
246276|NCT00329628|"~     The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is~     safe and prevent blood clot which may form after total hip replacement operation.~   "
246277|NCT00329615|"~     The study is designed to evaluate whether daily insulin treatment to weight losing cancer~     patients attenuates progression of cancer cachexia and improves metabolism.~   "
246278|NCT00329602|"~     This is an initial placebo-controlled study followed by open treatment evaluating the~     effectiveness and tolerability of ropinirole long-term in patients with moderate to severe~     Restless Legs Syndrome.~   "
246279|NCT00329589|"~     The purpose of this study is to determine the safety of Velcade when used with chemoradiation~     in cancer patients.~   "
246280|NCT00329576|"~     To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years~     after the first dose of the hepatitis B in the primary vaccination study.~   "
246281|NCT00329563|"~     The overall goal of this study is to determine the feasibility of initiating hypothermia in~     cardiac arrest patients as soon as possible in the field. In this pilot study we will~     randomize 125 patients after return of spontaneous circulation (ROSC) to hypothermia with~     rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV~     sedation and muscle paralysis or to standard of care following ROSC. The primary objectives~     of this study will be to determine whether temperature of 33-34oC can be achieved and~     maintained using this strategy. The primary outcome measures will include: temperature~     changes of the patients at time of admission to the hospital. Secondary analysis will include~     determining if the proportion of patients discharged from the hospital is increased in the~     group receiving hypothermia. If this initial pilot study can demonstrate feasibility in~     achieving and maintaining hypothermia, a larger randomized clinical trial to test the~     hypothesis that hypothermia initiation in the field will increase the proportion of patients~     surviving following cardiac arrest will be planned.~   "
246282|NCT00329550|"~     This is a multi-centre, open-label extension study in subjects who showed clinical response~     to induction therapy in the treatment of subjects with active Crohn's disease in the~     double-blind main study C87037 (NCT00291668).~   "
246283|NCT00329537|"~     The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and~     6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to~     assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously~     once daily for 8 weeks in comparison with placebo, in patients with moderately to severely~     active Crohn's disease.~   "
246284|NCT00329524|"~     One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the~     ear) ranging from mild to severe impairment. To date there is no effective therapy that seems~     to help the tinnitus sufferer. The purpose of this study is to develop a therapy using a~     technique called Repetitive Transcranial Magnetic Stimulation (rTMS) to hopefully alleviate~     or reduce the symptoms of tinnitus.~      This research is being conducted at the University of Arkansas for Medical Sciences (UAMS).~     Up to twenty (20) right handed subjects, either males or females, 19-65 years of age, with~     tinnitus that is severe enough for those persons to seek medical attention will have been~     seen as patients in the UAMS Hearing and Balance Center, where routine testing includes a~     physical exam, hearing tests, evaluation of middle ear status, and an MRI scan (a machine~     that acquires visual images of the brain). A diagnosis of tinnitus will be established after~     ruling out all other possible causes of the tinnitus.~   "
246285|NCT00329511|"~     High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is~     associated with an increased risk of development of pregnancy related high BP called~     preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature~     separation of the placenta from the uterus resulting in damage to the fetus and cesarean~     delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the~     mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes,~     and therefore, medications to lower BP are used for moderate to severe hypertension. To date~     the literature on the medications used in pregnancy is extremely limited.~      Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central~     nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does~     not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak~     antihypertensive medicine given three or four times a day and frequently needs changes in the~     dose or may require an additional medication to control BP. This may lead to a greater chance~     of non compliance. Another option is Clonidine which is an effective antihypertensive~     treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the~     maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects.~     Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be~     released and absorbed transdermally over a 7-day period.~      The study will determine differences in compliance between the two antihypertensive regimens-~     oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and~     adequacy of BP control, as well as provide information on an alternate option for BP control.~   "
246286|NCT00329498|"~     To document therapeutic gain achieved by cyclic application of L-ascorbic acid (LAA)~     supplementation and depletion, while confirming safety and avoidance of clinically~     significant scurvy, in chemorefractory patients with acute myeloid leukemia (AML) and~     myelodysplastic syndromes (MDS).~   "
246287|NCT00329485|"~     The purpose of this research study is to test the effectiveness of CORvalen, a medical food,~     to increase cellular energy sufficiently to change or modify BNP levels in congestive heart~     failure patients.~   "
246371|NCT00328380|"~     The primary objective of this study is to assess the safety and tolerability of rifaximin 600~     mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy~     subjects to prevent travelers' diarrhea (TD) from all causes.~   "
246288|NCT00329472|"~     This study is randomized phase III trial designed to assess whether (preoperative)~     neoadjuvant chemotherapy followed by surgery plus adjuvant chemotherapy with gemcitabine and~     cisplatin (experimental treatment) improves 3-year disease-free survival, compared to surgery~     plus adjuvant chemotherapy with gemcitabine and cisplatin (standard treatment) in stage IB,~     IIA, IIB and T3N1 non-small cell lung cancer~   "
246289|NCT00329459|"~     This study was designed to determine efficacy of TREXIMA compared to placebo for the~     treatment of a menstrual migraine.~   "
246290|NCT00329446|"~     The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and~     safe in the acute treatment of patients with Generalized Anxiety Disorder.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
246291|NCT00329433|"~     A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most~     common complications after surgery. This may result in death if a clot breaks off and travel~     to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the~     incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In~     order to decrease the likelihood of this complication, patients receive by injection a blood~     thinning medicine. Heparin is the usual medicine used for this purpose following heart and~     lung surgery. Recently there have been reports that other medicines may be more effective~     than heparin for this purpose. Also there have been reports that some patients develop~     antibodies to heparin. When this occurs, this may prevent the heparin from being effective~     and may even promote the formation of blood clots. Antibodies to heparin may be present more~     often following heart and lung surgery than other types of surgery. There is a new medicine~     called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots~     following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood~     clots following hip surgery. The purpose of this study is to compare desirudin with heparin~     for the prevention of vein clots after heart and lung surgery.~   "
246292|NCT00329420|"~     This 26-week extension study evaluates the efficacy and safety of certolizumab pegol~     administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects~     with active Crohn's disease who had no clinical response at Week 6 to induction therapy in~     the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical~     response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this~     extension study.~   "
246293|NCT00329407|"~     This investigation will assess the effectiveness of topiramate in reducing ethanol~     consumption by alcohol dependent subjects. It also will seek to establish whether topiramate~     can be safely used in this population including whether it might be subject to abuse by~     alcohol dependent individuals.~      A secondary goal of this study is to assess the effects of topiramate on verbal fluency~     during treatment for alcohol dependence.~   "
246294|NCT00329394|"~     The principal objective is to evaluate the analgesic effectiveness of the systemic ketamine~     on the control of the pain (average consumption of morphine at 48 hours) at the~     alcool-dependent patient, in carcinological surgery ORL. The effect coanalgesic is found for~     low dose of ketamine and action anti NMDA seems to have a stabilizing effect on this~     particular type of patient. This imbalance of the receivers, with a greater number of r-NMDA~     among these patients would involve it a better analgesic effectiveness and less effects~     dysphoric, to see an improvement on the syndrome of weaning. The secondary objectives~     evaluate the pain, the ground (dependence with alcohol), the first request analgesic, the~     tolerance and the signs psychic (syndrome of weaning...) and the satisfaction of the patient.~   "
246295|NCT00329381|"~     In patients with at least moderate persistent allergic asthma controlled with inhaled~     steroids, omalizumab(administered per US product label), when compared to placebo, will~     provide the participants with significantly improved tolerability of specific allergen~     immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).~   "
246296|NCT00329368|"~     This is a Phase 1b clinical trial to assess the safety and tolerability of vaccination with~     EC90 (KLH-FITC) and GPI-0100 (adjuvant) followed by treatment with EC17 (Folate-FITC) in~     combination with low-dose cytokines (IL-2 and IFN-alpha) in patients with metastatic or~     refractory cancer.~   "
246297|NCT00329355|"~     This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium),~     formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.~   "
246298|NCT00329342|"~     Low back pain has become a major concern to employees and employers because of its negative~     impact on employee health and productivity.~      The objective of this study is to investigate whether a return-to-work intervention conducted~     during inpatient rehabilitation improves functional limitations that are related with low~     back pain and interfere with job performance.~   "
246299|NCT00329329|"~     The purpose of this study is to determine the maximally tolerated dose (MTD) and Phase 2~     recommended dose of satraplatin when administered in combination with capecitabine in~     patients with advanced solid malignancies.~   "
246300|NCT00329316|"~     To examine the preterm delivery rate of a preterm delivery high risk group of pregnant women,~     using once daily natural progesterone agent.~   "
246301|NCT00329303|"~     The primary objective is to assess the effect of re-treatment after relapse in subjects with~     moderate to severe chronic plaque psoriasis having responded to a first treatment.~   "
246316|NCT00329108|"~     The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus~     olanzapine in the treatment of acute mania. An open label extension will further evaluate the~     efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment~     was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007.~     Subjects that were enrolled at the time completed the study as per protocol. There were no~     safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was~     January 10, 2008.~   "
246317|NCT00329095|"~     This is an open-label study in patients who are currently using either a topical~     prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin~     plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the~     same eye(s). Compliance will be measured over the two months of participation.~   "
246318|NCT00329082|"~     To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in~     healthy volunteers.~   "
246302|NCT00329290|"~     The ability to diagnose and surgically repair poorly functioning heart valves has yielded a~     significant population of women that are of childbearing age with mechanical/ bioprosthetic~     heart valves. The clinical management of pregnant women with artificial heart valves during~     pregnancy has been difficult. Currently there have not been any controlled clinical trials to~     provide guidelines for a safe and effective anticoagulation. Current review of the literature~     has shown that oral anticoagulation with warfarin has been implicated to cause significant~     fetal morbidity including prematurity, decreased birth weight, birth defects (i.e.:warfarin~     embryopathy), abortions, still birth and neonatal mortality. Warfarin embryopathy refers to~     characteristic anomalies (nasal hypoplasia, eye defects, hypoplasia of extremities, deafness,~     mental and developmental retardation), that may occur when coumadin is used during first~     trimester and/or if used in doses >5mg per day during pregnancy. It has also been reported~     that intravenous and subcutaneous heparin has not been sufficiently effective in lowering~     maternal morbidity and mortality. Thromboembolic events, valve dysfunction leading to~     peripartum valve replacements, and maternal death have all been observed.~      The purpose of this study is to:~        -  Evaluate the outcome of pregnancy in women with mechanical/bioprosthetic heart valves.~        -  Identify the risks posed to both mother and fetus during treatment with various methods~          of anticoagulation during pregnancy.~      The survey will be conducted in three phases:~      Physicians who respond to:~      Phase 1: A questionnaire asking physicians whether they have cared for a patient with~     prosthetic heart valve after year 1990 will be mailed, faxed or e-mailed to all members of~     the Society of Maternal Fetal Medicine.~      Phase 2: Responding physicians will provide information for the investigators to contact~     their patients and obtain a telephone/signed consent form (approved by the LBMMC IRB) to~     participate in the study and release their medical records to the investigators.~      Phase 3: Data will be collected by the investigators/research nurse by reviewing medical~     records and interviewing referring physicians and the patients.~      Although the information may not have immediate benefit to the subject, the data collected~     may help the medical community develop a more effective guideline of selection of prosthetic~     valves in women in the childbearing age and care of patients with prosthetic heart valves~     during pregnancy.~   "
246303|NCT00329277|"~     Standard perimetry provides information on topographical retinal sensitivity to light~     stimuli, however the said locus is not necessarily the preferred locus for fixation. Standard~     perimetry could also be used as a way for macular scotoma mapping, indirectly showing the~     fixation locus. Topographic acuity at the preferred retinal locus can be determined if~     correlation between loci with high sensitivity, eccentric fixation loci and potential visual~     acuity measurements are correlated.~      PURPOSE OF THE STUDY:~      Determination of visual acuity at preferred retinal locus in Low Vision patients with ARMD~     using eye standard automated and computerized perimetry methods.~   "
246304|NCT00329264|"~     The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and~     safe in the acute treatment of patients with Generalized Anxiety Disorder.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
246305|NCT00329251|"~     The purpose of this study is to determine whether an immunization schedule is beneficial to~     HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load.~   "
246306|NCT00329238|"~     The general aim of this study is to determine the comparative safety and efficacy of~     dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR)~     of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous~     thromboembolism in patients who have been successfully treated with standard doses of an~     approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous~     Thrombo-embolism.~   "
246307|NCT00329225|"~     This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or~     placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have~     not achieved their blood glucose goal using insulin alone. This study requires a total of~     seven visits during 28 weeks.~   "
246308|NCT00329212|"~     The purpose of this study is to investigate the pharmacokinetics in humans of San Huang Xie~     Jin Tang (SHXJT) and evaluate the bioequivalence between herbal concentrate and traditional~     decoction.~   "
246309|NCT00329199|"~     Through the TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy;~     Project 3a) we aim to test the efficacy of a brief treatment aimed at treating depression and~     family conflict among a population of adolescents with depression, and thereby reducing the~     future chance of these adolescents initiating smoking. We will examine Attachment-Based~     Family Therapy (ABFT) for the treatment of depression in comparison with Enhanced Usual Care~     for Depression (EUCd). Reduction of depression will be measured by a clinically significant~     reduction of score on the Hamilton Rating Scale for Depression. Second, we will examine how~     reduction of family conflict mediates the effect of ABFT on depression. The third aim will be~     an exploratory look at the potential prevention of the onset of smoking. Specifically, we~     will examine if reduction of depression and/or reductions in family conflict regardless of~     treatment type reduces the initiation of smoking or reduces smoking behavior at 52 weeks.~     These aims will be accomplished by randomizing 240 adolescents to one of two treatment~     conditions: a) Attachment-Based Family Therapy or b) Enhanced Usual Care for Depression.~     Patients randomized to the ABFT condition will receive 6-12 weeks of family therapy. Patients~     enrolled in the EUCd condition will be referred for outpatient psychological services at an~     agency that fits their geographic and financial needs. Research staff will help patients~     navigate the referral process. All participating therapists will have carried out the full,~     manualized treatment with 2-3 pilot cases prior to treating any randomized cases.~   "
246310|NCT00329186|"~     The purpose of this study is to determine if the relative difference in PK between extensive~     metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and~     venlafaxine ER when a single dose is administered.~   "
246311|NCT00329173|"~     To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin~     after 6 weeks treatment~   "
246312|NCT00329160|"~     The primary objective of this study is to evaluate that 76 weeks of treatment with~     rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic~     volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic~     subjects with coronary heart disease (CHD).~   "
246313|NCT00329147|"~     The purpose of this study is to evaluate the effects of multiple doses of DVS SR and~     paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.~   "
246314|NCT00329134|"~     No pediatric formulations of quinine exist. Therefore, quinine tablets are broken into 2 or 4~     parts, according to the body weight. Based on the body weight, 1/2 or 1/4 a tablet is~     administered to the child.~      At this moment, quinine sulphate pellets are developed. These pellets enable an adequate~     dosing according to the body weight.~      56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body~     weight.~   "
246315|NCT00329121|"~     The purpose of this study is to determine whether the topical application of PEP005 is safe~     and effective for the treatment of cutaneous squamous cell carcinoma in situ (SCCIS, Bowen's~     disease).~   "
246320|NCT00329056|"~     In Parkinson's Disease, the mitochondrial membranes in cells that produce dopamine become~     damaged by oxidants, leading to the death of these cells and progressive tremor, slowness of~     movement and the loss of neurons in the substantia nigra (a part of the brain that is~     involved in movement). Mitoquinone is targeted to reach the membrane of mitochondria and~     provide protection from damaging oxidants. There are no treatments currently available to~     slow the progression of PD and this trial will help advance the development of this unique~     disease modifying drug.~      This trial will enroll 120 participants with untreated early onset of PD. Participants will~     be randomized to receive 1 of 3 treatments: 40 mg of MitoQ tablets, 80 mg of MitoQ tablets or~     placebo. The researchers, participants and sponsor will all be blinded to the treatment~     allocation. Participants will be assessed after 1, 2, 3, 6, 9, 12 months of treatment and~     again 28 days after their last dose. The effectiveness of the trial drug will be measured via~     the Unified Parkinson's Disease Rating Scale (UPDRS). The safety of the trial drug will be~     monitored via regular participant examinations, blood tests, ECG and collecting information~     on adverse events.~   "
246321|NCT00329043|"~     The goal of this clinical research study is to learn if the addition of sunitinib malate~     (SU011248) to hormone based castration is an effective treatment for shrinking or controlling~     the tumor before having the prostate removed.~   "
246322|NCT00329030|"~     This study is designed as a Phase III, multicenter trial, comparing progression-free survival~     (PFS) after autologous hematopoietic stem cell transplantation using a standard Rituxan plus~     BEAM transplant regimen versus a regimen adding Bexxar to BEAM.~   "
246323|NCT00329017|"~     A study to examine the potential associations between common single nucleotide polymorphisms~     and pre-cancerous conditions in breast tissue specimens from postmenopausal women.~   "
246324|NCT00329004|"~     The purpose of this research study is to determine the highest dose of the drug (BMS-690514)~     that can be safely given to patients with advanced cancer.~   "
246325|NCT00328991|"~     This study is a double-blinded, controlled clinical intervention trial to evaluate the~     efficacy of duct tape occlusions therapy for the treatment of common warts. 80 patients~     completed this study, and were randomized 1:1 to receive pads which contained either~     moleskin+transparent duct tape or moleskin alone. The patients wore the pad over the target~     wart for 7 days at a time, removed the pad on the evening of the 7th day, and replaced the~     pad on the 8th day. This cycle was repeated for 8 weeks or until the wart resolved. The~     hypothesis was that duct tape occlusion therapy would be more therapeutic than moleskin for~     the treatment of the common wart. However, in our study there was only 21% resolution rate in~     the duct tape arm vs. 22% in the control group.~   "
246326|NCT00328978|"~     The purpose of the study is to assess and compare the side effect profile, safety,~     tolerability and efficacy of schizophrenic or schizoaffective subjects non- or partially-~     responsive to 800 mg/day of quetiapine treated with either 800 mg/day or more than 800 mg/day~     of quetiapine during 8 weeks.~   "
246327|NCT00328965|"~     This study was designed to evaluate the anti-hypertensive efficacy of lacidipine in~     hypertensives with Type 2 diabetes and effectiveness on endothelial cell function in Korean~     population.~   "
246328|NCT00328952|"~     The purpose of this study is to evaluate the changes in various aspects of auditory verbal~     hallucinations during 24-week antipsychotic treatment in naturalistic condition.~   "
246329|NCT00328939|"~     This is a local registration study in China to compare the safety and efficacy of ARIXTRA to~     Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of~     components.~   "
246330|NCT00328926|"~     Sponsor has decided to discontinue Luveris® in the United States (US) due to level of~     customer demand for this product, and not due to any efficacy or safety concerns.~   "
246331|NCT00328913|"~     The aim of the study is to show evidence of the efficacy of 5-HTP to induce satiety and to~     reduce food intake (confirmatory study).~      The primary objective of the present study is to determine:~        -  the effectiveness of a 5-HTP preparation on satiety markers (before intake of a meal and~          during the day)~      The secondary objectives of the present study are to determine the effectiveness of a 5-HTP~     preparation on:~        -  food consumption (amount and composition) during a free meal (dinner);~        -  wellness after one week supplementation;~        -  the intermeal interval;~        -  body weight and waist-hip ratio (WHR).~   "
246332|NCT00328900|"~     24 patients randomly divided into two groups, one of the groups receiving atropine in~     addition to the planned anaesthesia. Skin conductance parameters to be compared between the~     two groups.~   "
246333|NCT00328887|"~     This a pilot clinical study focused on enhancing the patient's anti-tumor immune response in~     individuals with esophageal cancer by altering the genetic repertoire of the tumors to~     express CD40L, an activator of dendritic cells. This will be accomplished by endoscopic~     administration to the tumors of AdcuCD40L, an adenovirus gene transfer vector expressing the~     coding sequence of the human CD40L cDNA. This study is designed to assess the hypothesis that~     it is safe to administer the AdcuCD40L vector to individuals with esophageal cancer.~   "
246334|NCT00328874|"~     Study hypothesis:~      A 6-week p.o treatment with 5 mg/Kg Coenzyme Q10 is safe and tolerable,increases the brain's~     metabolism and ameliorates clinical symptoms in patients with PSP.~   "
246346|NCT00328718|"~     This study is being conducted to demonstrate the superior clinical effectiveness of~     Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent~     asthma in children aged 6-14 years, and to assess the effect of each treatment~     [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function,~     asthma control, Health Outcomes including the child's quality of life as measured by~     Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life~     as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at~     selected centers where a valid translation is available.~   "
246347|NCT00328705|"~     This is an acute, prospective, multi-center, non-randomized, investigational device exemption~     (IDE) clinical study.~   "
246348|NCT00328692|"~     The study is being conducted to examine whether KW-3902IV will result in greater improvement~     in signs and symptoms of heart failure, with less treatment failure than standard therapy,~     when it is added to IV loop diuretics in subjects with acute heart failure syndrome and renal~     impairment.~   "
246335|NCT00328861|"~     Background:~        -  Natural killer (NK) cells are large lymphocytes (a type of white blood cell) that are~          important in the immune response to cancer.~        -  IL-2 (Aldesleukin) is a substance the body makes that controls the growth and function~          of many types of cells. The Food and Drug Administration has approved IL-3 for treating~          metastatic melanoma and kidney cancer. (Metastatic disease is cancer that has spread~          beyond the primary site.)~      Objectives: To determine the safety and effectiveness of treating metastatic melanoma and~     kidney cancer with laboratory-treated NK cells and IL-2.~      Eligibility: Patients 18 years of age or older with metastatic melanoma or kidney cancer who~     have previously been treated with high-dose IL-2.~      Design:~        -  Leukapheresis. Patients under leukapheresis to obtain NK cells for the treatment~          regimen. Blood is collected through a needle in an arm vein and directed through a cell~          separator machine where white blood cells are extracted. The rest of the blood is~          returned to the patient through a needle in the other arm. NK cells are removed from the~          white blood cells and treated for re-infusion into the patient.~        -  Chemotherapy. Starting 8 days before infusion of the treated NK cells, patients receive~          intravenous (IV, through a vein) infusions of cyclophosphamide and fludarabine to~          suppress the immune system.~        -  NK cell infusion. Patients receive a 30-minute IV infusion of NK cells 2 days after the~          last dose of chemotherapy.~        -  IL-2 therapy. Within 24 hours of the NK cell infusion, patients receive high-dose IL-2~          as a 15-minute IV infusion every 8 hours for up to 5 days. A second cycle of IL-2 is~          given about 14 days after the first.~        -  Blood tests and biopsy. Patients have frequent blood tests during the treatment period~          and may be asked to undergo a biopsy (surgical removal of a small piece of tumor or~          lymph node) at the end of treatment to look at the effects of the treatment on the tumor~          immune cells.~        -  Follow-up evaluation. Patients are evaluated 4-6 weeks after completing treatment. They~          have a physical examination, scans of tumor sites, blood tests and blood sampling (or~          leukapheresis) to examine the response to treatment. Patients who improve with treatment~          return for evaluations every month. Those whose tumor grows again after originally~          shrinking may receive one additional treatment course.~   "
246336|NCT00328848|"~     The purpose of this study is to determine whether comprehensive post-hospitalization~     interdisciplinary care management can be an effective care delivery model to improve outcomes~     in low-income frail elderly.~   "
246337|NCT00328835|"~     Chronic glaucoma is one of the leading causes of blindness and visual loss in the developed~     world. It is a condition where long term exposure to high eye pressures (intra-ocular~     pressure) damages the nerve fibres in the eye. This damage can be seen by examiners as~     changes in the optic nerve. The exact mechanism of how the high intra-ocular pressure causes~     nerve damage is unknown. Both physiological and mechanical mechanisms are thought to play a~     role. Previous authors have reported structural changes in the connective tissue of optic~     nerves of eyes with glaucoma. Structural changes in the optic nerve head which affect the~     mechanical compliance of the nerve may be significant in the cause of glaucomatous nerve~     damage. This study aims to assess the compliance of the optic disc in subjects with and~     without glaucoma. We would test compliance by imaging the optic discs of participants before~     and during a brief (less than two minutes) increase in intra-ocular pressure. We would aim to~     repeat the tests on the same subjects 3 years later to see how compliance changed. We would~     also seek to correlate other important parameters such as corneal thickness and visual field~     changes with our findings~   "
246338|NCT00328822|"~     Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine~   "
246339|NCT00328809|"~     Cardiovascular disease is the leading cause of death and disproportionately prevalent in~     patients with kidney disease. Spironolactone has been shown to improve survival in the~     general population with heart failure by up to 30%. We wish to study the safety and~     tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk~     population of patients on hemodialysis. We will study and closely monitor subjects over a~     period of 12 months, during which they will be receiving spironolactone for a period of 6~     months.~   "
246340|NCT00328796|"~     Midwives and obstetricians are currently using acupuncture for several health problems during~     pregnancy and childbirth. The investigators wish to determine whether acupuncture can be used~     as pain relief during the repair of lacerations in the female pelvic floor following~     childbirth.~      Three acupuncture points in the ear have been reported highly effective for perineal pain~     relief. A scientific trial will compare acupuncture with traditional local anaesthetics when~     midwives conduct perineal repair just after delivery in the hospitals of Southern Denmark.~   "
246341|NCT00328783|"~     The purpose of this study is to evaluate the use of a device that helps coordinate the~     breathing cycle in the radiation treatment of the breast in order to minimize the radiation~     dose to the normal structures around the breast.~   "
246342|NCT00328770|"~     This study investigates whether sirolimus could decrease the rate of hepatoma recurrence~     after liver transplantation in high risk hepatoma patients.~   "
246343|NCT00328757|"~     The purpose of this study is to determine whether it is safe to give a regular diet as the~     first postoperative meal in patients who underwent surgical treatment for clinically~     early-stage gynecologic cancer.~   "
246344|NCT00328744|"~     The rising prevalence of obesity in the United States is believed to be due to increased~     exposure to adverse environmental factors, such as food portion sizes and increased dietary~     variety. Although decreasing portion sizes is a strategy used in weight loss programs,~     research has not studied the effects of decreasing dietary variety. Cross-sectional studies~     show a positive association between variety and body weight and in our own studies the~     investigators have shown that greater reductions in the number of different snack foods~     (i.e., cookies, chips) consumed predicted greater decreases in overall caloric and fat intake~     and greater weight loss. Limiting variety may reduce intake through long-term~     sensory-specific satiety and/or monotony. Reducing dietary variety is a novel dietary~     approach with the potential to improve long-term weight loss, which has not been studied as a~     clinical strategy in obesity research. The objective of this application is to conduct a~     randomized controlled trial of a behavioral weight loss intervention limiting the number of~     different snack foods consumed. Two hundred overweight and obese participants will be~     randomized to a standard behavioral intervention (Standard) or to a standard behavioral~     intervention that also limits the number of different snack foods consumed (Limited Variety).~     Both conditions will receive an 18-month standard behavioral intervention, using behavioral~     techniques (i.e., self-monitoring) to change eating behaviors. Participants in the Limited~     Variety condition will also limit variety in snack foods to only two chosen snack foods~     throughout the intervention. Measures of weight, snack food consumption and hedonics, and~     diet satisfaction will be taken at 0, 6, 12, and 18 months. This investigation will~     determine:~        1. if the Limited Variety condition produces greater weight loss than the Standard~          condition at 18 months;~        2. if the Limited Variety condition consumes fewer servings and calories from snack foods~          than the Standard condition;~        3. if limiting snack food variety produces long-term sensory-specific satiety and/or~          monotony.~      Relevance: Experimental studies show that limiting dietary variety profoundly reduces intake.~     To date, there is no dietary prescription that has been tested that capitalizes on the effect~     of variety on intake that can be maintained. This will be the first investigation to examine~     methods of manipulating dietary variety that can be adhered to over time and that influence~     intake, weight loss, and weight loss maintenance.~   "
246345|NCT00328731|"~     We sought to determine the efficacy of NAET® in permanently eliminating milk allergy for a~     sample of patients.~      We hypothesize that the subjects in the experimental group will show similar level of~     allergies and sensitivities initially on all nine diagnostic measures used here. After~     receiving the NAET treatments, the Experimental group will demonstrate a significant~     reduction in the milk sensitivities and allergies when compared to the control group at the~     final evaluation using same diagnostic measures.~   "
246349|NCT00328679|"~     The main purpose of this study is to determine if standard and investigational tests used to~     help diagnose and treat food allergies can provide information that will be useful in~     determining the cause of dyspepsia and helpful in designing a treatment plan. The study will~     also determine if there is a connection between positive allergy tests and inflammation in~     the upper abdomen.~   "
246351|NCT00328653|"~     The primary objective of this study is:~        -  To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus~          vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment~          period.~      The secondary objectives of this study are:~        -  To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;~        -  To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and~        -  To assess the decrease in frequency of concomitant artificial tears use.~   "
246352|NCT00328640|"~     Is a secondary prevention intervention, focused on implementation of standardized pre-printed~     discharge orders for hospitalists, effective at increasing utilization of the following~     evidence-based treatments 6 months after discharge for ischemic stroke:~        1. Treatment with statins,~        2. Control of hypertension, and~        3. Anticoagulation in patients with atrial fibrillation.~   "
246353|NCT00328627|"~     The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily~     (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.~   "
246354|NCT00328614|"~     The purpose of this study is to determine the safety and effectiveness of Samarium-153 when~     given in combination with hormonal and external beam radiation therapy in men with high risk~     prostate cancer.~   "
246355|NCT00328601|"~     The primary objective of the trial is to determine the optimal dose of orally (tablet)~     administered thioctic acid in the treatment of symptoms of diabetic polyneuropathy (dPNP). It~     is expected that at least one of the three dosages to be tested (600, 1200, or 1800 mg~     tablets) of orally administered thioctic acid improves the symptoms of dPNP as compared to~     placebo.~      Secondary objectives are evaluations of other variables pertinent to dPNP, safety, and~     tolerability.~   "
246356|NCT00328588|"~     A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously~     treated with chemotherapy.~   "
246357|NCT00328575|"~     The purpose of this study is to determine if using intensity modulated radiation therapy for~     brain metastases is safe and will improve local control more than standard whole brain~     radiation therapy.~   "
246358|NCT00328562|"~     The purpose of this study is to determine the safety and effectiveness of Iressa when used~     with a short course of high dose radiation therapy in patients with lung cancer.~   "
246359|NCT00328549|"~     The purpose of this study was to describe the time course and extent of hemoglobin (Hb)~     changes and the erythropoietic response to PEG-IFN/RBV-induced anemia In HCV-infected~     subjects.~   "
246360|NCT00328536|"~     The purpose of the study is to determine whether a 6-week treatment with 4 g Omacor/day~     improves the baseline and postprandial endothelial function (after a high-fat meal) in~     patients with type 2 diabetes mellitus.~   "
246361|NCT00328523|"~     In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the~     recommended target goal (esc 2003 recommendations ldl>=1.15 g/l) to compare the efficacy and~     the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient~     motivation on diet or physical activities or both).~   "
246362|NCT00328510|"~     Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible~     immobilization of the patient's head. This randomized study compares the efficacy of two~     commonly used forms of immobilization used for SRT.~   "
246363|NCT00328497|"~     This single center, open-label study will evaluate the safety and efficacy of Panzem~     (2-methoxyestradiol, 2ME2) Nanocrystal Dispersion (NCD) administered orally with recombinant~     human monoclonal antibody against vascular endothelial growth factor (bevacizumab)~     administered intravenously, in patients with locally advanced or metastatic carcinoid tumors.~   "
246364|NCT00328484|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Symptoms include~     shortness of breath, wheezing, and difficulty exercising. Increasing exercise and physical~     activity may relieve the symptoms of COPD and may also slow the progression of the disease.~     The purpose of this study is to evaluate the effectiveness of a lifestyle activity program~     versus a traditional exercise program at increasing the amount of physical activity among~     individuals with COPD.~   "
246365|NCT00328471|"~     The purpose of this randomized controlled trial (RCT) is to test the effectiveness of a~     comprehensive interdisciplinary post-discharge stroke care management intervention in~     improving the overall well-being of 190 stroke survivors as compared to 190 patients who~     receive usual post-discharge stroke care.~   "
246366|NCT00328458|"~     The purpose of this study is to determine the safety of the drug EPO906 that could shrink~     tumors when used with radiation therapy in cancer patients.~   "
246367|NCT00328445|"~     The purpose of this study is to determine the effectiveness of the Positive Action program on~     reducing negative behaviors, increasing positive behaviors and improving academic achievement~     of elementary school students.~   "
246368|NCT00328432|"~     To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and~     reexcision.~   "
246369|NCT00328419|"~     The antioxidant system of very low birth weight infants is immature. This immaturity is~     implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy.~     The main source of oxidant is oxygen, and parenteral nutrition is contaminated with oxidant.~     Photoprotection decreases the oxidant load infused with parenteral nutrition. In a~     preliminary study, photoprotection reduced the frequency of pulmonary bronchodysplasia,~     increased the quantity of enteral nutrition tolerated, and decreased the arterial blood~     pressure among very low birth weight infants. The aim of this study is to evaluate the impact~     of photoprotection on oxidant related diseases among very low birth weight infants. This~     study is a randomized multicenter trial. In the intervention group, photoprotection is~     applied until the infusion of parenteral nutrition with amber bags, tubing, and syringes. The~     quality of photoprotection is controlled by measuring malondialdehyde and cysteine after 24~     hours of infusion. The control group will receive parenteral nutrition with transparent bags~     and tubing. The outcomes are evaluated at 36 weeks, and 680 infants will be enrolled, with~     stratification among centers and gestational age.~   "
246370|NCT00328393|"~     The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no~     data are available looking at this effect in detail. Especially, ambulatory blood pressure~     has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure~     lowering effects.~   "
246374|NCT00328341|"~     It is anticipated that the use of tissue oxygen monitoring to measure brain tissue oxygen and~     deltoid muscle oxygen will provide more precise information about focal brain ischemia and~     systemic hypoperfusion than current techniques and measures such as blood pressure, heart~     rate and intracranial pressure. Understanding the relationship between tissue oxygen tension~     collected from the brain and deltoid muscle in critically injured patients could lead to a~     broader understanding of the important metabolic and cellular events that occur following~     severe injury and the changes induced by therapeutic interventions. Furthermore, the use of~     interventions designed to improve tissue hypoxia, as measured by low brain or muscle tissue~     oxygen, may improve mortality or neurological recovery after systemic trauma or head trauma~     compared to current approaches that do not involve tissue metabolic monitoring.~   "
246375|NCT00328315|"~     The goal is to conduct a clinical pilot study to evaluate the use of a rotating multi-segment~     slant-hole collimator in the detection of myocardial defects.~   "
246376|NCT00328302|"~     The type 1 diabetes patients who were still normoalbuminuric and normotensive, after 17 years~     duration and a second research kidney biopsy, could enter the double blind treatment study of~     Atacand or Placebo.~      The treatment study continues for five years treatment and ends with a third kidney biopsy.~      The study hypothesis is that the effect of ARB during 5 years on the histopathology are more~     pronounced than the effect on histopathology of placebo.~   "
246377|NCT00328289|"~     Hypothesis: Intradialytic blood pressure and dialysis efficacy (in terms of urea removal)~     improve under electrical muscle stimulation or passive leg movement on a treadmill.~   "
246378|NCT00328276|"~     The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive~     symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system~     hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the~     pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission has~     been considered as a novel treatment approach. To date, there have been several trials on~     NMDA enhancers reported. For example, sarcosine (N-methylglycine, a glycine transporter I~     inhibitor) showed therapeutic effects not only in chronically stable patients but also in~     acutely exacerbated ones when added-on to antipsychotics. In addition, sarcosine yields~     excellent safety profiles, in comparison to current antipsychotics.~      It remains unclear whether NMDA enhancers, such as sarcosine, can serve as monotherapy for~     schizophrenia. The aims of this project are to examine the efficacy and safety of sarcosine~     monotherapy for acutely-ill schizophrenic patients, and to compare the effects of 2~     grams/day, effective dose, with 1 gram/day, ineffective lower dose.~   "
246379|NCT00328263|"~     The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus~     placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.~   "
246380|NCT00328250|"~     This study will evaluate the effectiveness of an online cognitive behavioral therapy~     intervention in improving sleep, mood, and cognitive functioning in people with insomnia.~   "
246381|NCT00328237|"~     The purpose of this study is to evaluate the incidence of neutrophil engraftment after~     transplantation of one or two cord blood units meeting a predetermined total minimum cell~     dose of 2.0 x 10 to the seventh total nucleated cell (TNC)/kg.~   "
246382|NCT00328224|"~     To evaluate the dental status of children using ritalin and suffering from ADHA in comparison~     to healthy children.~   "
246383|NCT00328211|"~     The overall goal of this study is to better understand how cholesterol is absorbed and~     utilized in the body(metabolism) and how serum cholesterol affects the development of~     hardening of the arteries (atherosclerosis). The purpose of aim 1 is to assess the role of~     the amount of different bile acids in the intestine and how they affect the absorption,~     synthesis and digestion of cholesterol. The effect that these bile acids have on how fast the~     gall bladder empties and the release of a hormone in the blood after a meal will also be~     studied. The purpose of aim 2 is to assess the role of phospholipid (a fat containing the~     element phosphorus) in the intestine and how it affects the absorption, synthesis and~     digestion of cholesterol in normal people and in people with a genetic condition (mdr3~     deficiency)that affects phospholipid and bile acid metabolism. The purpose of aim 3 is to~     assess the role of a material that acts like a detergent called Pluronic F-68 which is known~     to block the absorption of cholesterol. The purpose of aim 4 is to determine if the~     cholesterol from food and the cholesterol made by the body are digested and absorbed~     differently.~   "
246384|NCT00328198|"~     This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and~     safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for~     patients with relapsed or refractory B-CLL who have been previously treated.~   "
246385|NCT00328185|"~     Transplantation is the preferred method of treating many forms of end-stage organ failure.~     While short-term results have improved, long-term outcomes remain inadequate. Myocardial~     fibrosis could potentially have an adverse effect on long-term cardiac function. We wish to~     study the degree of fibrosis to see if we can predict survival following pediatric heart~     transplantation.~   "
246386|NCT00328172|"~     The objective of the current study is to investigate the efficacy, safety and tolerability of~     several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of~     treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition,~     there will be an open-label treatment arm with metformin for sensitivity measurement with~     this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in~     this study.~   "
246387|NCT00328159|"~     Usual dietary therapies of mitochondrial fatty acid oxidation disorders (FAO) are based on 3~     strategies:~        -  limitation of lipid intake in the diet;~        -  supplementation of the diet with medium-chain triglycerides (MCT) for patients affected~          with disorders of long-chain FAO;~        -  some specific supplementations (for example, L-carnitine).~      These strategies are often ineffective. The aim of the present study is to evaluate new~     therapeutic ways based on the underlying energetic defect observed in these disorders. The~     long-term goal is to develop efficient therapies of these disorders.~   "
246388|NCT00328146|"~     Re-operative surgery in children is extremely challenging and injury to the underlying~     cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary~     bypass is required in an emergency, there are often limited sites for peripheral cannulation.~     Injury to the heart can easily result in catastrophic complications and death.~   "
246389|NCT00328133|"~     Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa)~     to control severe hemorrhage following injury when traditional measures have failed. Despite~     promising results from several small studies, there remain several unanswered questions~     regarding the use of this relatively expensive product in injured patients including:~        -  The timing of administration~        -  Selection of appropriate patients who are most likely to benefit~        -  The effective dose in injured patients~        -  The potential need for repeated dosing~        -  The need for administration of platelets and correction of acidosis prior to~          administering the first dose~        -  The risks associated with the use of rFVIIa including venous and/or arterial thrombosis~        -  The potential for rFVIIa to cause or aggravate post-injury organ failure and/or~          infectious complications~        -  An analysis of cost versus benefit The purpose of this study is to collect a large~          sample of patients from multiple institutions in order to address the issues listed~          above. To this end, the Western Trauma Association Foundation is sponsoring a~          multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled~          hemorrhage.~   "
246390|NCT00328120|"~     The primary objective of this study is to assess the tolerability of 500mg fulvestrant in~     postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer~   "
246391|NCT00328107|"~     The purpose of this study was to determine the dose-related safety, immunogenicity, and~     protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy~     adults.~   "
246392|NCT00328094|"~     Aggressive intraoperative and postoperative management of blood glucose may substantially~     decrease perioperative cardiovascular and infectious complications in diabetic and~     non-diabetic patients undergoing vascular surgery.~      The purpose of this study is to compare the tight versus traditional blood glucose control in~     diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative~     fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections,~     overall morbidity and 30-day mortality.~   "
246393|NCT00328081|"~     The purpose of this study is to see whether care gap(s) exist in the management of obesity~     and its related conditions in obese patients seen by primary care physicians and specialists.~     The study will also look at whether there is a compliance and adherence gap that exists in~     patients prescribed medication for obesity management.~   "
246394|NCT00328068|"~     Background:~      Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification~     and/or diagnosis of spondyloarthritis have limitations when applied to early disease.~     Moreover, MRI is not part of any of the established criteria and the precise role of MRI in~     early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI)~     changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper~     patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the~     members of the ASAS International Working Group decided to conduct a prospective multi-centre~     study to evaluate (validate) the new candidate criteria, and to assess their performance as~     diagnostic criteria.~      Aims of the study:~        1. To evaluate the new candidate criteria for axial SpA in a multi-centre setting.~        2. To assess the potential role of the new candidate criteria to be used as diagnostic~          criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is~          mandatory as are longer periods of follow-up .~        3. To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria~          against criteria which are tailored to either predominant axial disease or predominant~          peripheral disease. To accomplish this, both patients with predominant axial disease~          (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis)~          will be included.~   "
246395|NCT00328055|"~     The purpose of this study is to compare the acceptability, usefulness, self-efficacy and~     comprehension of an easy-to-read advance directive form versus a standard advance directive~     form written at a post graduate reading level.~   "
246396|NCT00328042|"~     The objective of this study is to compare the efficacy of a 6-session hepatitis C~     self-management workshop to a hepatitis C self-management self-study program. Both~     interventions are designed to help people with hepatitis C learn to actively self-manage~     their chronic HCV infection, and ultimately, to improve health outcomes for veterans with HCV~     who are not receiving Interferon-based treatment. Participants complete a total of four~     assessments. The fourth assessment, a 12-18 month assessment is an approved addition to the~     original study design~   "
246397|NCT00328029|"~     Recently, several conditioning regimens did not include total body irradiation (TBI) anymore,~     especially in the case of young children due to cognitive sequelae and late effects on growth~     and height. Thus, such effective chemotherapy conditioning regimens were developed to avoid~     these complications. Busulfan is one of the major drugs used in these treatments, but, is~     also administered in high dose chemotherapy followed by autograft. In both situations, long~     term pulmonary side effects were diagnosed in a few cases. Even if the occurrence is not very~     frequent, the clinical management is a real challenge regarding the reduced quality of life~     and life expectancy of these patients. Up to now, no correlation was done between respiratory~     sequelae and busulfan pharmacokinetics. Hence, in the investigators' pediatric~     onco-hematological unit, a prospective study will begin and last three years to assess the~     respiratory side effects due to busulfan and their potential links with individual drug~     pharmacokinetic measures. These results will be compared to patients treated with TBI during~     the same period of time.~   "
246398|NCT00328016|"~     The purpose of this study is to investigate the nature of the physiological reasons for the~     decreases in resting blood pressure that can result from systematic practice of~     computer-guided breathing exercises or meditative relaxation.~   "
246399|NCT00327990|"~     This is a two part study (screening and treatment). The first part (screening) is designed to~     evaluate the percentage of patients missed in diagnosing osteoporosis by general~     practitioners (GP's). The second part (treatment) is designed to determine the preference by~     patients for the once monthly ibandronate or the once weekly alendronate.~   "
246436|NCT00327509|"~     The aim of the study is to compare messenger ribonucleic acid (mRNA) expression of various~     genes in lymphocytes between glaucoma patients and sex and age-matched healthy subjects. A~     secondary objective is to analyze the impact of different forms of glaucoma or of a~     vasospastic propensity on the findings.~   "
246400|NCT00327977|"~     Congenital heart disease is a major cause of morbidity and mortality in infants. Many cardiac~     defects require surgical palliation or repair in the newborn period. The effects of chronic~     hypoxia on growth and development are unclear. Infants with very severe cardiac defects may~     undergo surgery in infancy, but often this cardiac surgery can provide only palliation, not~     correction. As a result, these infants are exposed to a physiology of chronic hypoxia during~     the neonatal period through infancy, a critical period of growth and development. The optimal~     oxygen saturations for infants with palliated cardiac defects is unknown. The purpose of this~     study is to analyze the growth and development of infants with post-surgical palliation in~     infancy and assess variations in oxygenation saturations and hemodynamics as they relate to~     weight gain, linear growth and increases in head circumference during the first three years~     of life.~   "
246401|NCT00327964|"~     Malaria remains a disease that causes much death and sickness, especially in sub-Saharan~     Africa. An accurate, simple, and inexpensive method of diagnosing malaria is urgently needed.~     The purpose of this study is to evaluate a different diagnostic method compared to those most~     frequently used. The study may also identify the factors causing false positive and false~     negative results using the alternative method. Participants will be 600 Ugandan children aged~     1-10 years who are enrolled in protocol 04-068. Those who develop a fever over the 12 month~     duration of the study will be tested for malaria by both the standard and the new methods.~     These tests will require a few drops of blood to be collected by finger prick. Subjects will~     be treated on the basis of standard diagnostic testing (i.e. expert microscopy).~   "
246402|NCT00327951|"~     Failure to thrive and difficulty gaining weight is a sign of uncompensated congestive heart~     failure (CHF). Infants with Trisomy 21 and complete atrioventricular canal defects (CAVC)~     frequently develop uncompensated CHF and weight gain failure pre-operatively. A weight of 5~     kg has been suggested as optimal for timing of CAVC repair. A delay in surgical repair often~     occurs if weight gain stalls and reaches a plateau prior to reaching 5 kg. A retrospective~     review performed by Kogon, et al, of children undergoing surgery for VSD at CHOA at Egleston~     recently reported that age and weight at surgery may not, however, be associated with adverse~     surgical outcome.~      The purpose of this study is to determine the optimal timing for surgical correction of CAVC~     in Trisomy 21 infants based on reaching a plateau of failed weight gain despite maximal~     anti-congestive and nutritional therapy.~   "
246403|NCT00327938|"~     The purpose of this study is to find out if the tetanic noxious stimuli and the measured skin~     conductance response can be used as a test in patients before surgery to have an indication~     about what amount of analgesics the patient will need during surgery.~   "
246404|NCT00327925|"~     Blood is collected from patients and cultured in a CimTube (a test tube with stimulation~     media) for several days. Following the culture step, the supernatant fluid is tested for the~     presence of CAAb on experimental test kits.~      Null Hypothesis: There is no relationship between the presence or absence of ovarian cancer~     (OC) and the CAAb i.e. d=0.~      Alternative Hypothesis: The expectation of the CAAb in the cancer population differs from~     that of the control population, i.e. m1 is not equal to m2. Since the sign of the difference~     is not important, the test will be two-sided.~   "
246405|NCT00327912|"~     The purpose of this study is to compare the outcome in a broad perspective after laparoscopic~     Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of~     superobesity (body mass index [BMI] > 50 kg/m2).~   "
246406|NCT00327899|"~     Inotropic therapy is a well-established practice for children with advanced congestive heart~     failure (CHF). Inotropes are intravenous medications to help the heart pump stronger and~     prolong life while awaiting heart transplantation. Traditionally children have been~     maintained on inotropic therapy in the hospital under close, monitored supervision. The~     United Network for Organ Sharing (UNOS), which governs organ distribution, has now changed~     listing criteria allowing patients awaiting heart transplantation to be discharged to home,~     yet maintaining a higher status on the waiting list. In adults, home inotropic therapy has~     been shown to be a safe and cost-effective bridge to transplantation. To date, there are no~     data on the use of home inotropic therapy in children.~      Hypothesis:~      We request to do a retrospective chart review of patients receiving this therapy to determine~     safety and efficacy of continuous ambulatory home inotropic therapy in children.~   "
246407|NCT00327886|"~     The purpose of this retrospective study is to review the postoperative medical management of~     infants who underwent bidirectional Glenn operation from January 1, 2003 to December 31, 2005~     who were significantly cyanotic.~   "
246408|NCT00327873|"~     The main goal of this study is to establish the effectiveness of palliative oxygen in the~     context within which it is usually provided--relief of the sensation of breathlessness and~     improvement in quality of life for people with maximally-treated life-limiting illness.~   "
246409|NCT00327860|"~     The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute~     of Diabetes and Digestive and Kidney Diseases (NIDDK), in collaboration with the Eunice~     Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the~     National Heart, Lung and Blood Institute (NHLBI) funded a cooperative agreement including two~     Clinical Coordinating Centers (at Children's Hospital of Philadelphia and at Children's Mercy~     Hospital in Kansas City), a central biochemistry laboratory (at the University of Rochester)~     and a Data Coordinating Center (at Johns Hopkins School of Public Health) to conduct a~     prospective epidemiological study of children with chronic kidney disease (CKD).~   "
246410|NCT00327847|"~     The purpose of this study is to determine the average dosage of oral vitamin D~     supplementation to maintain optimal vitamin D levels in the body and to see if there are~     differences in the response to oral vitamin D supplementation between African-American and~     Caucasian subjects.~   "
246411|NCT00327834|"~     The specific aim of this study is to assess the efficacy and safety of atomoxetine compared~     with placebo in outpatients with binge eating disorder.~   "
246412|NCT00327821|"~     The objective is to compare the effectiveness of 4 different commercial weight-loss diets~     available to adults in the UK.~      This is achieved with a 6 month multi-centre randomised unblinded controlled trial of~        -  Dr Atkins' New Diet Revolution,~        -  The slimFast Plan,~        -  The weight Watchers Pure Points Programme,~        -  Rosemary Conley's Eat Yourself Slim Diet & Fitness Plan.~        -  No diet (control)~      Subjects are a community based sample of 300 (60 per group) otherwise healthy overweight and~     obese adults.~      Main outcome measures are weight and body fat change over 6 months.~   "
246414|NCT00327795|"~     Recently, a paper was published that compared outcomes of patients requiring repair of aortic~     coarctation and ventricular septal defect. Some surgeons opt to repair both defects in one~     surgery while other surgeons do the repair in two separate operations. Recently at Children's~     Healthcare of Atlanta, we have adopted the practice of correcting both defects during the~     same operation but through two separate incisions (one on the chest and the other through the~     ribs on the side. This reduces the amount of time the patient is on the heart-lung bypass~     machine during surgery. This study is a review of patient charts to compare outcomes of~     patients who have had surgery to repair their coarctation and VSD during 2002 through 2005.~   "
246415|NCT00327782|"~     Palliative care in pediatric oncology and neurology is well described in the literature.~     There is a lack of information on the care of children terminally ill due to heart failure. A~     significant number of children are diagnosed with terminal heart failure for which palliative~     care is required.~      Objective:~      To describe palliative care of children over one year of age with end-stage heart failure,~     including need for and types of pain control, hospice use, need for and use of home nursing~     and quality of life issues.~   "
246416|NCT00327769|"~     This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment~     compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.~   "
246417|NCT00327756|"~     This study will examine whether mitochondrial function is impaired in patients with bipolar~     disorder. Mitrochondria are small organelles inside the cell that are responsible for energy~     production. Recent studies in animals and humans suggest that abnormalities of mitrochondria~     may be involved in bipolar depression. The study will also examine whether the food~     supplement Coenzyme Q10 (CoQ10) improves mitochondrial function and symptoms such as~     depressed mood, low energy, anxiety or slowness in thinking and movements in bipolar~     patients. CoQ10 has been used to increase cell energy production and as an antioxidant. It~     has had some benefit in patients with Parkinson's disease and migraine and in prolonging~     survival in patients with cancer and heart failure.~      Patients 18-65 years of age with bipolar disorder who are currently in a depressive episode~     of at least 4 weeks duration may be eligible for this study. The study has four phases, as~     follows:~      Phase I: Medication Withdrawal~      Patients taper off all psychotropic medications, usually over 1 to 2 weeks.~      Phase II: Baseline Evaluation~      After being off all medication for about 2 weeks, patients undergo the following procedures:~        -  Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). The two~          procedures are performed in an MRI scanner. Both tests use a strong magnetic field and~          radio waves to obtain images that provide information on brain anatomy and chemistry.~        -  Blood tests to assess mitochondrial function isolated from blood cells.~        -  Skin biopsy for tests of mitochondria. A small sample of skin tissue 5 x 5 millimeters~          is surgically removed.~      Phase III: Administration of CoQ10 or Placebo~      Participants are randomly assigned to take either CoQ10 or placebo (an inactive look-alike~     substance) twice a day by mouth. While taking the study medication, patients have the~     following procedures periodically:~        -  Rating scales for anxiety and depression and adverse events.~        -  Check of vital signs.~        -  Blood and urine sample collections.~      Phase IV: Study Completion~      At the end of the 8 weeks of treatment, patients have a physical examination and~     electrocardiogram, and the procedures in phase II are repeated. Participants may then receive~     short-term treatment (up to 12 weeks) with medications for bipolar depression, followed by~     referred to a community physician for long-term treatment.~   "
246418|NCT00327743|"~     The goal of this phase I-II clinical research study is to find the highest safe dose of~     XRP9881 and capecitabine that can be given in combination in the treatment of metastatic~     breast cancer in patients who have been previously treated by taxanes and anthracyclines. The~     safety and effectiveness of this combination will also be studied. Patients participating in~     the study will be asked to give additional blood samples to look at the level of study drugs~     in the blood.~   "
246419|NCT00327730|"~     The purpose of this study is to evaluate the efficacy of Eperisone HCl in the treatment of~     Acute Musculoskeletal spasm associated with Low-Back Pain.~   "
246420|NCT00327717|"~     The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as~     adjunctive therapy in medically refractory patients receiving other antiepileptic drugs~     (AEDs).~   "
246421|NCT00327704|"~     Objective: To determine whether the early administration of albumin as an expander and~     antioxidant would improve survival on the 28th day for septic shock patients.~      Design: Prospective, multicenter, randomized, controlled versus saline, stratified on~     nosocomial infection and center.~      Setting: 27 Intensive Care Units (ICU) in France~      Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris~      Patients: 800 patients could be included during the first 6 hours of their septic shock.~   "
246422|NCT00327691|"~     The primary objective of this study is to determine the degree of additional reduction in~     cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently~     accepted minimum target level for patients with pre-existing CHD. Secondary objectives~     include the safety profile of this treatment strategy, its cost-effectiveness, effect on~     other atherosclerotic-related events and procedures, and total mortality.~   "
246423|NCT00327678|"~     This study is a multicenter trial of treatment for young ALL patients. All ALL patients will~     receive the same steroid pre-phase in order to evaluate sensitivity or resistance. Then,~     patients will be included into 3 specific trials according to biological features~     (immunophenotype, cytogenetics, and molecular biology).~      Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) 2005:~        -  T ALL or B ALL non Ph (N=810 patients planned).~        -  GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned).~        -  GRAAPH 2005: ALL Ph+ (N=270 patients planned)~   "
246424|NCT00327665|"~     As the licensed pneumococcal vaccine is not always satisfactory in elderly, new~     investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note:~     The study consists of the primary phase (106068): vaccination and follow-up and the extension~     (106072) of the primary phase: 1 year follow-up.~      This protocol posting details the procedures of both the primary & extension phase.~   "
246425|NCT00327652|"~     This clinical trial evaluated the safety and tolerability of CRS-100, an investigational~     agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is~     attenuated by genetic modification to limit cell to cell spread and invasion of liver cells.~     These attenuations result in decreased virulence of CRS-100 in mice but retain the ability of~     the investigational agent to stimulate immunity in test animals and generate anti-tumor~     activity in mice. The primary objective of this study was to determine the maximum tolerated~     dose (MTD) and to explore the safety profile of a single intravenous dose of CRS-100 in~     consenting volunteers. Immunological response to CRS-100 and tumor status of study~     participants were also measured. Participation in this first clinical trial with CRS-100 was~     restricted to adults with carcinoma refractory to standard treatment (or for whom no standard~     treatment is available) and who additionally had liver metastases.~   "
246451|NCT00327314|"~     The protocol aims at reducing transplant toxicity and mortality in patients with multiple~     myeloma.~   "
246426|NCT00327639|"~     Treatment of patients with beta thalassemia in North America has altered dramatically during~     the past 40 years, with improvements in transfusion therapy and introduction of iron~     chelation therapy. Thalassemia patients now enjoy an increased life expectancy to the fifth~     and sixth decades of life, with fertility and childbearing becoming important issues. Data~     regarding this important topic remain limited, without clear data regarding iron control~     including serial assessment of hepatic iron concentration, the need for assistance in~     becoming pregnant, and use of iron chelating agents during pregnancy. As the life expectancy~     increases and overall health improves in thalassemia, clear data on fertility, pregnancy~     complications, and the effect of pregnancy on maternal health in thalassemia patients are~     necessary since these will have a direct impact on patient care, quality of life, and patient~     expectations.~   "
246427|NCT00327626|"~     The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of two~     ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic~     agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes,~     despite ongoing maximal treatment with OAD.~   "
246428|NCT00327613|"~     Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy~     is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the~     final end point in blinding diseases of the optic nerve such as glaucoma. It is known that~     neuronal cell death in glaucoma occurs by apoptotic mechanism. In earlier studies, the~     investigators demonstrated that the process of apoptosis is reflected in circulating~     leukocytes by different parameters, like differential messenger ribonucleic acid (mRNA)~     expression and an increased fragmentation of the deoxyribonucleic acid (DNA). Such~     alterations point out a relationship between cellular stress and apoptotic events.~      Based on the results of mRNA-expression, the investigators also expect alterations on the~     protein level.~      This study is, therefore, designed to characterize the proteome related to the proteins~     involved in cell death related pathways.~      Thus the expression pattern of several proteins in leukocytes from patients with primary open~     angle glaucoma will be analyzed by techniques like Western-blot and tandem mass spectrometry.~     These samples will be compared with healthy controls. In addition, they will be also compared~     with samples from patients with Parkinson's disease. Since glaucoma is a neurodegenerative~     disease, these patients will be included as a positive control in this study.~   "
246429|NCT00327600|"~     AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can~     be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment~     of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is~     designed to determine whether the two drugs can be safely combined together, and the Phase 2~     part of the study is designed to provide additional safety data and to gain an understanding~     of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the~     findings from prior clinical studies of DTIC alone.~   "
246430|NCT00327587|"~     The purpose of this study is to determine the safety and efficacy of the various combinations~     of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.~   "
246431|NCT00327574|"~     Studies have established that high blood pressure (BP) is the most common risk factor for~     cardiovascular disease (CVD). Despite a heavy burden of hypertension (33% of all persons aged~     45 years and over), there are no reliable data on comparative strategies to manage~     hypertension in Pakistan. Our Wellcome Trust funded pilot study in Karachi, Pakistan on 320~     adults aged 40 years and over showed that the prevalence of hypertension (95% CI) was 40.3%~     (34.9-45.7%), and CVD was 32.5% (27.6-37.8%).~      We will now conduct a study with two components: 1) cross sectional study to determine the~     prevalence of CVD, and its determinants in Karachi, Pakistan; and 2) prospective, 2x2~     factorial design, cluster allocation intervention study to evaluate the impact of a i)~     Population approach of household health education (HHE) by community health workers (CHW) on~     BP levels of population aged 5 years or over in low-middle income communities of Karachi; and~     ii) High-Risk approach of special BP management administered by intensively trained local~     general practitioners on BP levels of hypertensive subjects aged > = 40 years from the above~     population.~      The cost effective BP control strategy would serve as a model for a much-needed national~     level hypertension control programme in Pakistan, and possibly other developing countries in~     South Asia.~      We hypothesize that 1) HHE delivered by trained CHW is superior to no HHE in lowering BP~     levels of the population; and 2) management of hypertension by specially trained GPs is~     better than usual care provided in the communities of Karachi in lowering blood pressure of~     hypertensive subjects.~   "
246432|NCT00327561|"~     The hypothesis of the existence of a causal association between the systemic~     infectious/inflammatory burden represented by periodontitis and endothelial function assessed~     by flow mediated dilatation of the brachial artery (FMD) is the subject of the proposed~     investigation.~      The objective of this randomized controlled clinical trial is to evaluate the effects of~     periodontal therapy on endothelial function assessed by Flow mediated dilatation (FMD).~      The rationale for this project is twofold:~        -  Establish the extent of acute systemic inflammation and endothelial dysfunction~          associated with the delivery of subgingival instrumentation for the treatment of chronic~          periodontitis~        -  Establish whether or not improved control of chronic periodontal infections results in~          improved endothelial function and thus the existence of a causal association between~          periodontitis and endothelial dysfunction.~   "
246433|NCT00327548|"~     The purpose of the study is to evaluate the effectiveness of relaxation, with or without~     guided imagery, for treating children with functional abdominal pain. The study will evaluate~     a child's ability to decrease the amount of pain with these techniques to allow continuation~     of normal daily activities at home and at school. The hypothesis is that these relaxation~     techniques will help decrease reports of abdominal pain and improve levels of activity.~   "
246434|NCT00327535|"~     This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia~     in patients with non-small cell lung cancer receiving first line myelosuppressive~     chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9~     micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the~     approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg~     every week). The anticipated time on study treatment is <3 months and the target sample size~     is 100-500 individuals.~   "
246437|NCT00327496|"~     Hepatoma ranks the first on the cancer mortality list in Taiwan, and there are currently no~     other effective treatment options for advanced HCC. Therefore, alternative medical~     intervention is needed to improve the survival and quality of life of these patients.~     Dendritic cells are the most potent type of antigen presenting cells in the human body, and~     are involved in the regulation of both innate and adoptive immune responses. If we use~     matured antigen presenting cells pulsed in vitro with appropriate tumor associated antigens~     under optimal activation conditions. It is anticipated that such treatment might generate or~     reactivate a cytotoxic T lymphocyte response against tumor cells and thereby inhibit tumor~     growth.~      Although there are excited results of tumor vaccine in animal models but successful clinical~     tries are rare. There are still some problems needed to be resolved such as immune deficiency~     of the cancer patients or the defect of T cell receptors or the problems of tumor escape.~     There are complex compositions in tumor cells to be a tumor antigen that will influence the~     efficacy of tumor vaccine, so we are going to use tumor lysate to be a tumor antigen.~      In this study, the generation of dendritic cells from the patient’s peripheral blood will use~     rhGM-CSF and rhIL-4 as stimulating factors, and matured dendritic cells will pulse with tumor~     lysate, the ex vivo T cell cytotoxicity for the primary tumor cell will be test. We hope to~     cooperate with basic study group in our hospital to do more ex vivo tests and clinical trials~     in the future.~   "
246438|NCT00327483|"~     Information technology will be brought directly to renal transplant recipients to help them~     learn about the large number of medications they are required to take on a life long basis,~     in order to prevent errors and improve safety.~   "
246439|NCT00327470|"~     The purpose of this study is to determine the benefits of treating subjects with neovascular~     age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization~     (CNV) as compared to those with established CNV. Additionally, the study would like to~     determine the efficacy of Macugen in preserving visual function in those subjects having CNV~     secondary to neovascular AMD.~   "
246440|NCT00327457|"~     The investigators aim to use a randomized design to test the effects of 1) tailored physician~     recommendations, relative to non-specific recommendations, and 2) coordinated physician~     office management systems on patient adherence to colorectal cancer screening~     recommendations.~   "
246441|NCT00327444|"~     This study was designed to characterize the effect of aflibercept in participants with~     advanced chemoresistant ovarian cancer.~      Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap,~     ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in~     participants with advanced ovarian cancer~      Secondary objectives: Safety, tolerability, paracentesis-related parameters,~     participant-reported outcome.~   "
246442|NCT00327431|"~     Research suggests that blood pressure is influenced by both genetic and environmental~     factors. The goal of this study is to find genes that play a role in blood pressure and~     understand how they interact with life events (such as job stress) to influence blood~     pressure. We hypothesize that the gene for endothelin-1 is associated with increased blood~     pressure. Further, we predict that this genetic relationship is moderated by psychosocial~     stress factors, specifically job strain and marital cohesion.~   "
246443|NCT00327418|"~     A study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on~     cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (NIDDM) who~     have a history of either hypertension, retinopathy, microalbuminuria, macroalbuminuria, or~     who currently smoke, but who do not have established corornary heart disease or other~     macrovascular disease.~   "
246444|NCT00327405|"~     The use of ocular compression and suture release have helped to improve the safety and~     decrease the risks of glaucoma filtering surgery. This study looks at the decrease in~     intraocular pressure and glaucoma medications required following glaucoma filtering surgery.~   "
246445|NCT00327392|"~     Very often patients receive medications before a diagnostic, therapeutic, or surgical~     procedure to help them relax, keep them calm, and to relieve them from pain. This is called~     procedural sedation. With respect to minimal-to-moderate procedural sedation for minor~     surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a~     medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified~     form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of~     propofol, and is being studied to see if it can safely keep patients calm and relaxed during~     their medical procedure and then allow for rapid and clear-headed recovery.~   "
246446|NCT00327379|"~     The objective of this study is to evaluate the safety and efficacy of aprotinin as compared~     to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective~     spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation~   "
246447|NCT00327366|"~     The study investigated whether bright artificial light may influence menstrual cycle and~     ovulation conclusively, and what underlying hormonal changes for this effect are.~   "
246448|NCT00327353|"~     Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but~     also on technical properties of the inhalers. Different inhalers have different internal~     resistances and therefore it is expected that patients with limited airflow may have~     different exposure rates of drugs delivered from different devices~   "
246449|NCT00327340|"~     This study is for patients with cancer of the prostate gland that has metastasized or spread~     outside the prostate to other parts of the body. Patients have already been treated with a~     drug called docetaxel or Taxotere® (with or without the addition of a steroid called~     prednisone) some time in the recent past. They either did not respond to this therapy or~     responded to this therapy, but now the cancer is progressing (growing larger or has spread to~     other areas of the body).~      Custirsen (OGX-011) is an experimental drug that has been shown to increase the effectiveness~     of chemotherapy in several kinds of tumors, including prostate cancer.~      Both docetaxel and mitoxantrone have anticancer activity in prostate and are approved by~     Health Canada and the Food and Drug Administration for the treatment of patients with~     prostate cancer.~   "
246450|NCT00327327|"~     AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug~     imexon in combination with an approved drug, gemcitabine, for the treatment of patients with~     previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and~     gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the~     highest doses of the two drugs that can be safely combined together.~   "
246452|NCT00327301|"~     Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy~     is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the~     final end point in blinding diseases of the optic nerve such as glaucoma. It is known that~     neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies the~     investigators could demonstrate that the process of apoptosis is reflected in circulating~     leukocytes by different parameters, like differential mRNA expression and an increased~     fragmentation of the DNA. Such alterations point out a relationship between cellular stress~     and apoptotic events.~      Based on the results of mRNA-expression the investigators also expect alterations on the~     protein level.~      This study is, therefore, designed to characterize the proteome related to the proteins~     involved in cell death related pathways.~      Thus, the expression pattern of several proteins in leukocytes from patients with primary~     open angle glaucoma will be analyzed by techniques like Western-blot and tandem mass~     spectrometry. These samples will be compared with samples from healthy controls. In addition,~     they will also be compared with samples from patients with Parkinson's disease. Since~     glaucoma is a neurodegenerative disease, these patients will be included as positive controls~     in this study.~   "
246453|NCT00327288|"~     Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously~     treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer.~     Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for~     these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3~     week cycle. The objective of the protocol is to determine the highest dose of imexon which~     can be given with a full dose of docetaxel, and to provide information to enable the design~     of a future study focused on one or more specific cancer types.~   "
246454|NCT00327275|"~     To assess the effects of a 16-week individualized, intensive strength training program in~     patients with rheumatoid arthritis. Primary and secondary outcomes include: strength and body~     composition, function, disease activity, pain, quality of life.~      We hypothesized that improvements would be seen in all of the above outcomes.~   "
246455|NCT00327262|"~     This study will investigate the efficacy and tolerability of a short (6 months) high dose~     therapy followed by a standard dose compared to a continuous treatment with a standard dose~     of imatinib (Glivec®) in pretreated Philadelphia chromosome- positive (Ph+)/BCR-ABL+ CML~     patients in chronic phase.~   "
246456|NCT00327249|"~     AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple~     myeloma. The first phase of the study is designed to determine a safe dose of imexon that can~     be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of~     the study is designed to provide additional safety data and to gain an understanding of~     whether imexon can improve the outcome for patients with multiple myeloma~   "
246457|NCT00327236|"~     The investigators believe that T cells, cells that are a part of the immune system, are what~     are causing the neurological problems while also attacking tumor cells. This protocol studies~     the clinical status of patients with paraneoplastic neurological disorder (PND) as well as~     their blood to understand the relationship between their neurological disease, their cancer,~     and their immune system.~   "
246458|NCT00327223|"~     AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and~     pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three~     weeks. The objective of the study is to determine the maximally tolerated dose, the~     pharmacokinetics, and the toxicity of the drug on the designated schedule.~   "
246459|NCT00327210|"~     BGATHome is an interactive, web-based training program designed to improve the ability of~     adults with Type 1 Diabetes to recognize, predict, treat, and avoid extreme blood glucose~     (BG) events. It was developed at the University of Virginia over the past 20 years with~     funding from the National Institutes of Health and the American Diabetes Association.~     BGATHome provides important knowledge about personal insulin use, food, and activity regimens~     that influence BG levels. Users of this program will learn to monitor and recognize the cues~     that signal hyper and hypoglycemic events, and enhance their ability to control these~     fluctuations.~   "
246460|NCT00327197|"~     To evaluate and compare the expression and change in expression of key severe asthma targets~     at baseline in mile to moderate asthmatics vs. severe asthmatic subjects.~      To evaluate and compare the airway pathology at baseline and changes in airway pathology in~     relation to asthma severity.~   "
246461|NCT00327184|"~     The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two~     doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants~     (at 3 & 5m) compared to NeisVac-C™ given with Infanrix™ hexa.~      The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and~     reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m~     of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior~     to the administration of the booster doses. The Protocol Posting has been updated in order to~     comply with the FDA Amendment Act, Sep 2007.~   "
246462|NCT00327171|"~     This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma~     receiving aflibercept.~      The primary objective was to compare the objective response rate of Aflibercept~     (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered~     intravenously (IV) every 2 weeks with historical control in participants with advanced~     ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant~     to platinum and topotecan and/or liposomal doxorubicin.~      The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential~     biological and pharmacogenomic markers of study drug activity, and health-related quality of~     life.~      This study employed an Independent Review Committee (IRC) for radiological tumor assessments.~     For all tumor assessment-related efficacy variables, two analyses were performed: the primary~     analysis was based on Independent Review Committee (IRC) reviewed data and the secondary~     analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the~     IRC reviewed data is reported for this study.~   "
246463|NCT00327158|"~     The purpose of the study is to see if there is a difference in the amount of fat droplets~     reaching the heart during surgery between the standard reamer currently used and a new reamer~     system which is expected to reduce the fat going into the blood, via an intraoperative~     echocardiography done through the food pipe.~   "
246464|NCT00327145|"~     This study is designed to provide additional efficacy and safety data for a treatment~     strategy based on the combination valsartan with amlodipine in hypertensive patients~     previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will~     be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg~     with possible addition of HCTZ~   "
246465|NCT00327132|"~     1. The complete histological and molecular remission rate for antibiotics as 1st-line~          therapy for Hp-positive early-stage gastric lg- and hg-MALT lymphoma~        2. The durability of complete histological remission after antibiotics~        3. The usefulness of pattern of NF-kB and BCL-10 by IHC staining in prospectively~          predicting the Hp-dependence of gastric lg- and hg-MALT lymphoma~        4. The frequency of t(11;18) translocation in gastric lg- and hg-MALT lymphoma in Taiwan.~        5. The association between the CYP2C18/19 genetic polymorphisms and eradication of Hp~          infection after antibiotics.~   "
246466|NCT00327119|"~     The primary objective of this study is to assess the effect of treatment with ABX-EGF on best~     overall objective response rate by modified RECIST (confirmed complete or partial response)~     in Japanese subjects with metastatic colorectal cancer.~   "
246467|NCT00327106|"~     The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture~     surgery on the reduction of allogeneic red blood cell transfusion.~   "
246468|NCT00327093|"~     Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the~     response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based~     on biological markers and/or functional imaging. The response to treatment is evaluated by~     the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors [RECIST]~     criteria).~      Secondary Objectives:~        1. This trial is also analyzing the correlation between the magnitude of response to~          treatment at 2 months (stabilization or objective response, RECIST criteria) and that of~          response observed after 6 months of treatment.~        2. The organisational objective is to develop a tumour bank of metastatic colorectal~          cancer.~      Population: The population includes 252 male and female patients with metastatic colorectal~     cancer justifying the use of cetuximab or bevacizumab, with no heart disease.~      Techniques: Computed tomography (CT scan), functional imaging (ultrasound with SonoVue);~     molecular imaging (positron emission tomography [PET] with fluorodeoxyglucose F18 [18-FDG]);~     and biology and pathology on microbiopsy of liver metastasis are used.~      Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies~     according to RECIST criteria at two months.~      Studied Factors:~      Radiology:~        1. CT scan: RECIST criteria (gold standard);~        2. Ultrasound with SonoVue injection: 1 representative target (delay of contrast~          appearance, peak of rising, curve of increase and decrease of the signal, area under the~          curve, time of average transit).~      Nuclear Medicine: PET scan and 18-FDG (standard uptake values [SUV])~      Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status;~     expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA~     polymorphisms~      Statistics:~        1. Descriptive analyses;~        2. Analysis of the appropriate threshold to measure: response to treatment by an ultrasound~          with SonoVue and by PET scan; correlation between response predicted by the ultrasound~          with SonoVue and the PET; conventional morphological CT at 2 months~        3. Analysis of prognostic factors:~             1. Evaluation of the role of each prognostic factor (pathology and imaging) on~               response to treatment;~             2. Multivariate analysis of prognostic factors;~             3. Analysis of the prognostic power of early response at 2 months on the response~               observed after 6 months of treatment.~   "
246469|NCT00327080|"~     This study will examine how blood pressure in the lungs is controlled in healthy people,~     people with HIV and people with HIV and pulmonary artery hypertension (high blood pressure in~     the lungs, also called PAH). PAH sometimes develops in people with HIV, but it is not known~     why this occurs or how best to treat it.~      Healthy volunteers and patients with HIV infection who are 18 years of age or older may be~     eligible for this study. All candidates are screened with a medical history, physical~     examination, electrocardiogram (EKG), chest x-ray, echocardiogram and blood tests.~     Participants undergo the following procedures:~      All participants have a right heart catheterization and forearm blood flow study.~        -  Catheterization study. A catheter (plastic tube) is placed in an arm vein and possibly~          in an artery in the arm. Then a large catheter is passed through a vein in the groin,~          neck or chest. Through this introducer catheter, another catheter is advanced into the~          right side of the heart and to the pulmonary artery. A facemask is put in place to~          measure the amount of nitric oxide produced by the lungs. Acetylcholine is infused~          through the catheter and its effects on blood pressure in the lungs and on the amount of~          nitric oxide exhaled is measured. After about 1 hour, the catheter and facemask are~          removed and a new catheter is inserted through the introducer catheter into the~          pulmonary artery. The subject is moved into an MRI scanner where blood flow is measured~          after infusion of three different medications: acetylcholine (causes blood vessels to~          expand and slows heart rate); sodium nitroprusside (causes blood vessels to expand and~          increases blood flow to the heart); and L-NMMA (decreases blood flow by blocking~          production of nitric oxide in cells lining the blood vessels).~        -  Blood flow study. Small tubes are inserted into the artery of the patient's forearm.~          These are used to infuse medicines and draw blood samples. Forearm blood flow is~          measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a~          rubber band device) placed around the forearm. When the cuffs are inflated, blood flows~          into the arm, stretching the strain gauge, and the flow measurement is recorded. A small~          lamp is positioned over the hand to measure the light reflected from the hand and blood~          flow in the forearm. Blood samples are then drawn to measure blood counts and proteins~          and other natural body chemicals. Then, forearm blood flow is measured after~          administration of small doses of sodium nitroprusside, acetylcholine and L-NMMA. There~          is a 20- to 30-minute rest period between injections of the different drugs.~      In addition, HIV-infected patients with PAH undergo the following tests to determine the~     cause of their PAH: CT scan of the lungs, pulmonary function tests, 6-minute walk test,~     quality-of-life assessment, assessment of difficulty in breathing, exercise testing while~     measuring oxygen breathed in and carbon dioxide breathed out, blood tests, monitoring of~     oxygen saturation during sleep for 1 night and ventilation/perfusion scan. For the~     ventilation/perfusion scan, the subject breathes in a small amount of radioactive aerosol~     while images are obtained of the radioactivity as it enters the lungs, and then pictures of~     the lungs are taken from multiple angles. Next, the patient receives an injection of tiny~     particles of albumin (a protein) containing a small amount of radioactivity and pictures of~     the lungs are taken that show the pattern of blood flow to the lungs.~      Patients with HIV and PAH who may benefit from the investigational drug, sildenafil (commonly~     known as Viagra), may continue to participate in the next stage of the study. They receive~     the first dose of sildenafil after completing the forearm blood flow study. They continue the~     drug for 16 weeks, returning to the clinic 1 week after the first dose and then every other~     week to monitor the response to treatment and drug side effects. At the end of 16 weeks,~     patients return to the clinic for a repeat evaluation, including blood tests, 6-minute walk~     test, echocardiogram, right heart catheterization and forearm blood flow study.~   "
246470|NCT00327067|"~     Blood donors who have a low fingerstick hemoglobin level are usually deferred from donating.~     A possible solution to the problem of repeated deferrals might be for Blood Banks to offer~     donors with low hemoglobin levels oral iron supplements. To determine the feasibility of such~     a program, this study will:~        -  Determine the frequency of iron deficiency in first-time and repeat blood donors~        -  Examine the effects of long-term blood donation on donor hemoglobin levels and iron~          stores~        -  Compare body iron stores in donors who have low hemoglobin values with that of donors~          who have acceptable hemoglobin values at the time of donation~        -  Determine what conditions other than iron deficiency lead to low hemoglobin levels in~          blood donors~        -  Determine the safety and effectiveness of giving oral iron tablets to donors with low~          hemoglobin levels~        -  Monitor the effect of oral iron administration on donor satisfaction and donor~          retention.~      First-time and repeat blood donors at the NIH Clinical Center Blood Bank 18 years of age and~     older may be eligible for this study. Participants include prospective donors who have an~     acceptable hemoglobin value at the time of donation and those whose hemoglobin level is~     determined to be too low for donation.~      All participants do the following:~        -  Answer medical questions about their diet, health, and family history of blood~          disorders.~        -  Have blood samples drawn from their arm for testing blood cell counts, iron stores, and~          other hemoglobin-related tests as appropriate.~      Donors with low hemoglobin also:~        -  Take iron supplements (ferrous sulfate) to replenish iron stores. (Donors who have~          previously had unpleasant side effects from ferrous sulfate are offered ferrous~          gluconate as an alternative.)~        -  Undergo evaluation with medical screening and laboratory tests at the time of future~          blood donations.~   "
246471|NCT00327054|"~     This is a pilot study.~      The aim of the investigators' study is to evaluate the effectiveness of nigella sativa seed~     in the treatment of dyslipidemia.~      Dyslipidemia is a common risk factor for cardiovascular disease, the leading cause for~     morbidity and mortality among patients.~      Nigella sativa is an easily available and acceptable remedy to treat dyslipidemia and at a~     low cost.~      It is expected that by scientifically determining the effectiveness of this intervention it~     will lead to its widespread use.~      This will provide a low cost alternative to treat dyslipidemia.~   "
246472|NCT00327041|"~     Antiplatelet therapy plays a key role in the prevention of complications related to coronary~     angioplasty and stenting (PCI) including procedure related myocardial damage. Aspirin and~     clopidogrel are now universally prescribed in patients undergoing these procedures. However,~     loading and maintenance doses have not been established and variation in individual response~     is emerging. New tests to assess the effects of these drugs are being developed but have yet~     to be incorporated into routine clinical practice. We will assess the effects of aspirin and~     clopidogrel in a consecutive series of patients undergoing angioplasty using new assays which~     can be carried out at the bedside. We will compare the results with alternative laboratory~     based tests and look for an association between the results, peri-procedural myocardial~     necrosis and subsequent cardiovascular events.~   "
246473|NCT00327028|"~     The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin~     (diphenine) in the treatment of bronchial asthma.~   "
246474|NCT00327015|"~     The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe~     and works better than taking either saxagliptin or metformin alone~   "
246475|NCT00327002|"~     Agents that increase HDL-C via reverse cholesterol transport could provide a new therapeutic~     option for the prevention of atherosclerotic cardiovascular disease. The investigators~     propose to investigate the effects of LY518674 on components that may likely affect~     atherogenesis in patients with the metabolic syndrome including HDL-C metabolism and reverse~     cholesterol transport pathways, the inflammatory response, and oxidative stress in human~     subjects.~      As an agonist of the nuclear peroxisome proliferator activated receptor (PPAR) alpha,~     LY518674 may affect the transcription of genes that encode various proteins involved in~     atherogenesis. This study will explore the consequences of altered transcription such as~     changes in messenger ribonucleic acid (mRNA) and protein levels as well as protein activity.~   "
246489|NCT00326794|"~     Background: Nonsurgical proximal humerus fracture is common, causing prolonged disability,~     for which the time to begin rehabilitation is not well determined. We assessed the~     feasibility and efficacy of early (within 3 days’after fracture) mobilisation of the shoulder~     compared with conventional 3-week immobilization followed by physiotherapy.~   "
246476|NCT00326989|"~     Extracorporal shock wave therapy is performed prior to cell therapy for induction of~     therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in~     patients with chronic ischemic heart disease following anterior myocardial infarction.~      Shock waves can induce growth factor expression in the ischemic myocardium and might augment~     homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h~     following shock wave therapy~   "
246477|NCT00326976|"~     The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size~     following balloon catheterization for acute myocardial infarction.~   "
246478|NCT00326963|"~     This single arm study will evaluate the efficacy, safety and tolerability of a new~     investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc~     bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new~     investigational PI will be administered according to the procedures of the early access~     program in which the patient is enrolled. The anticipated time on study treatment is 3-12~     months, and the target sample size is approximately 120 individuals.~   "
246479|NCT00326950|"~     The primary objective of this study is to determine the dose limiting toxicity and maximum~     tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to~     investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects~     (in evaluable cases) of E7389 in patients with solid tumors.~   "
246480|NCT00326924|"~     To determine if the age of blood transfused to new borns in the NICU setting has an impact on~     their outcome.~   "
246481|NCT00326911|"~     Eligible patients with metastatic pancreatic cancer will be treated with dual agent~     monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with~     gemcitabine~   "
246482|NCT00326898|"~     This randomized phase III trial studies sunitinib malate and sorafenib tosylate to see how~     well they work compared to placebo in treating patients with kidney cancer that has been~     removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to~     the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor~     cells that remain after surgery. It is not yet known whether sunitinib malate or sorafenib~     tosylate is more effective than placebo in treating kidney cancer.~   "
246483|NCT00326885|"~     The purpose of this study is to determine whether the investigational drug catumaxomab is a~     safe and effective treatment for recurrent symptomatic malignant ascites.~   "
246484|NCT00326872|"~     This phase II trial is studying how well AZD2171 works in treating patients with~     neurofibromatosis type 1 and plexiform neurofibroma and/or neurofibroma near the spine.~     AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor.~   "
246485|NCT00326859|"~     During their hospitalization, burn patients frequently require dressing changes that may be~     painful. Deep analgesia and sedation are used but carry the risk of remnant somnolence and~     other effects of anesthesia such as dizziness and nausea/vomiting. All these side effects may~     delay refeeding after the procedure, ambulation and physical therapy. Drugs from the opioid~     class are used to relieve pain during these procedures. Morphine with its slow onset and~     remnant sedation is difficult to use in these patients. Pro-emetic properties and histamine~     liberating effects also make this drug non optimal for iterative procedures. Fentanyl, a~     synthetic opioid with shorter onset and lower incidence of nausea and vomiting, is the~     standard drug used in dressing changes in burn patients. It is metabolized by hepatic~     glucoconjugation. Remifentanil, a well known novel opioid, that has a unique metabolism~     independent from renal or hepatic functions, is metabolized by a non specific esterase. It~     has a very short half-life (3.5 minutes) and should therefore be administered as a continuous~     infusion. The investigators hypothesized that the use of remifentanil for daily burn dressing~     changes is associated with less pain during procedures and faster recovery. Studied patients~     will be the ones requiring iterative dressing change procedures under sedation. The primary~     endpoint will be the maximal pain during the procedure. Secondary endpoints will be: average~     pain during and after the procedure; subjective sensation of comfort; total amount of opioids~     received; times to feeding after the procedure and ambulation after the procedure; comfort of~     the procedure according to the nurses; mobilisation according to the physical therapist; and~     safety of the analgesia technique. The study will be conducted according to the~     recommendations of the American Society of Anesthesiologists (ASA) that have been endorsed by~     the Canadian Anaesthetists' Society (CAS). All patients who consent will fast for at least 6~     hours before the procedure. The two following regimens will be compared: a bolus infusion of~     fentanyl, starting with 1 µg/kg, followed by 0.5 µg/kg as needed every 5 to 10 minutes versus~     continuous infusion of remifentanil adapted to ensure analgesia. The initial dose of~     remifentanil will be 0.1 µg/kg/min to be adjusted between 0.05 µg/kg/min and 2 µg/kg/min. To~     allow blinding during the study, patients will receive a double-blinded protocol with sham~     (normal saline) in one arm. In other words: for each procedure, the patient will always~     receive boluses, either of fentanyl or saline, and a perfusion, either of remifentanil or~     saline. According to power calculations, 30 patients will be necessary to achieve the primary~     end-points. The investigators plan to enroll 40 patients in the study to allow for some drop~     outs and to increase their statistical power.~   "
246486|NCT00326833|"~     The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and~     neurological disorders. Therefore, a proper and timely diagnosis and treatment is important.~     The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of~     vitamin B12 deficiency have increased since the 1980s. Consequently, the number of~     individuals treated with vitamin B12 has increased significantly.~      The objective of this project is to study the actual need for vitamin B12 injections in the~     group of individuals who have already started treatment. In order to investigate this, the~     investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12~     deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they~     will test if the individuals are able to absorb a physiological dose of vitamin B12 using a~     recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the~     vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be~     able to divide the patients into three groups:~        1. need life long injections with vitamin B12,~        2. only need supplementations with a small dose of oral vitamin B12, and~        3. no need for further vitamin B12 treatment.~      The perspective is that the new information from this study might be used for a future~     strategy for vitamin B12 treatment.~   "
246487|NCT00326820|"~     RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone~     metastases. It is not yet know whether ibandronate is more effective than zoledronate in~     treating bone metastases from breast cancer.~      PURPOSE: This randomized phase III trial is studying ibandronate to see how well it works~     compared with zoledronate in treating patients with newly diagnosed bone metastases from~     breast cancer.~   "
246488|NCT00326807|"~     This study assessed whether naltrexone, an opioid antagonist, might be effective in reducing~     excessive gambling behavior in people who also drink heavily. The efficacy of naltrexone was~     evaluated in a randomized, double-blind, placebo-controlled trial. Fifty-two subjects who had~     significant problems with both gambling and alcohol received 11 weeks of either naltrexone or~     placebo.~   "
246491|NCT00326768|"~     The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label~     treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and~     telmisartan 40 mg plus HCTZ 12.5 mg in patients with essential hypertension.~   "
246492|NCT00326742|"~     Aim of the project is to validate and functionally characterize the combined impact of~     candidate genes and stress exposure on drinking in adolescents. Lifetime and recent stress~     experiences and drinking are recorded in a sample of healthy young adults who are genotyped~     for polymorphisms in candidate genes related to alcoholism. All participants undergo a~     standard laboratory psychosocial stress test. Our hypothesis is that specific genes can be~     identified which influence drinking by modulating stress response.~   "
246493|NCT00326729|"~     Fluid resuscitation in burn patients is associated with major macrocirculatory and~     microcirculatory disturbances that have been poorly described. When done according to expert~     opinions, it is now rare to encounter the death of a patient due to an inadequate fluid~     resuscitation. Fluid resuscitation in burn patients is more opinion-based than~     evidence-based. Although burn admission to an intensive care facility is relatively rare, the~     burn patient is well suited to answer questions in the fluid resuscitation field because, as~     opposed to other critically ill patients:~        1. investigators do have a time ‘zero’ for burn patients; they know exactly when the insult~          occurred;~        2. apart from fluid resuscitation, the management of burn patients is uniform in the~          investigators' unit and is done according to various protocols;~        3. the burn population is more uniform than the septic population making confounders and~          background noises less likely; and~        4. as basic as it might sound, studying fluid resuscitation implies accomplishing a~          significant one; burn patients are the category of critically ill patients receiving the~          most important fluid resuscitation.~      Studies that have addressed the question of fluid resuscitation in burn patients are quite~     numerous. However, they are either under-powered, dealing with various interventions or~     outcomes and sometimes of poor methodological quality.~      Moving the investigators' focus from macrohemodynamic to microhemodynamic monitoring is now~     essential and due to recent technological advances, severe impairments in microcirculatory~     perfusion are now being recognized in various pathological states. What is now clear from~     various studies is the fact that even with restoring ‘normal’ macrocirculatory parameters,~     severe microcirculatory alterations can be seen.~      This study is an integral part of a program aimed to explore different questions regarding~     fluid resuscitation in burn patients. The aim is to characterize changes in fluid shift,~     fluid accumulation, and vascular volumes after burn injury and also to study the effects of~     an artificial colloid on different macrocirculatory and microcirculatory parameters. The~     primary end points are:~        1. fluid accumulation during the initial phase; and~        2. short term effects of colloids on macrocirculatory and microcirculatory parameters.~      This study will collect data on macro- and microcirculation derived from current monitoring~     systems. Data (see below) will be collected at defined time points and before and after the~     first two fluid challenges. If the fluid challenge occurs in a one hour time frame of a~     defined time point, only one assessment will be done.~        1. At defined time points: a set of data (see below) will be collected by the research team~          at baseline, 6, 12, 18, 24, 36, 48 and 72 hours after burn injury. Baseline values will~          be the ones obtained immediately after consent.~        2. Fluid challenges: Burn patients often require additional fluid bolus to maintain~          hemodynamic stability because of the following reasons: hypotension; decreased urine~          output (less than 0.5 ml/kg/hour); uncorrected metabolic acidosis; rhabdomyolysis;~          increasing hematocrit; or any other clinical reason according to the attending~          physician.~      In this study, the two first fluid challenges will be allocated according to a random list.~     One bolus will be Pentaspan (500 ml) and the other will be a crystalloid solution (Ringer's~     lactate 1000 ml). These two alternatives represent a true equipoise as they are equally~     acceptable because choosing one of them depends on the preference of the attending physician.~     Fluid challenges will be allocated using a randomised short block cross-over sequence.~      The following parameters will be measured at a fixed time and before and after the fluid~     challenges using different techniques.~      Parameters:~      Intrathoracic blood volume, extravascular lung water, total blood volume; extracellular~     edema; intraventricular preload, ventricular volumes, diastolic function; cardiac output;~     mixed venous saturation; oncotic pressure; microcirculatory assessment: number and diameter~     of capillaries, proportion of perfusion, and flow velocities.~      This is an observational, one-group study aimed at describing macrocirculation and~     microcirculation parameters in a burn patient population. The investigators arbitrarily plan~     to enroll 40 patients.~   "
246494|NCT00326716|"~     To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug~     exposure during pregnancy compared to drug exposure in historical data in human~     immunodeficiency virus (HIV) infected participants.~   "
246495|NCT00326703|"~     Commercial aircraft passengers are exposed to atmospheric pressures ranging from the pressure~     found at ground level to that encountered in the external environment at 8,000 feet. There is~     some evidence in the medical literature that symptoms of acute mountain sickness can result~     from ascent to altitudes of 6,300 to 10,000 feet by unacclimated persons during the first few~     days following ascent, probably due to the hypoxia that results from breathing air at the~     reduced ambient pressures at altitude. The logical hypothesis that follows is that exposure~     to 8,000 feet could cause hypoxia sufficient to adversely affect the comfort and well being~     of some commercial aircraft passengers on prolonged flights. There is insufficient data in~     the literature to validate this hypothesis.~      Exercise at sea level and at altitude reduces arterial oxygen levels. The logical hypothesis~     that follows is that the combination of moderate exercise and exposure to altitude could~     cause hypoxia sufficiently severe to adversely affect the comfort and well being of some~     people and that the combined effect of exercise and altitude on comfort and well being is~     greater than the effect of exercise or altitude alone. Again, there is insufficient evidence~     in the literature to substantiate this possibility.~      The purpose of this investigation is to test these hypotheses.~   "
246496|NCT00326690|"~     The purpose of the present prospective, randomized study is to investigate the clinical~     effectiveness of standardized left ventricular reconstruction surgery (LVR). In order to~     standardize the procedure, the operation will be performed with the Blue Egg, manufactured by~     BioVentrix, a subsidiary of CHF Technologies, Inc.~   "
246497|NCT00326677|"~     The Institute of Medicine has called for studies of indicated preventive interventions to~     reduce the incidence of mental illness in persons already symptomatic but not yet presenting~     with fully developed clinical syndromes.~      The investigators' Advanced Center for Interventions and Services Research in Late Life Mood~     Disorders has embraced the development and testing of preventive interventions as one of its~     key objectives. The investigators propose to test the following hypotheses related to primary~     prevention of major depressive episodes in old age, focusing on elderly patients who have~     symptoms of emotional distress but who are not yet presenting with the full syndrome of a~     major depressive episode.~      Hypothesis 1: Problem solving therapy (PST) will be superior to an attention-only control~     (dietary education) in lowering the two-year incidence of episodes of syndromal major~     depression in already symptomatic elderly primary care patients.~      Hypothesis 2: PST will also prevent higher levels of depressive symptoms and associated~     disabilities, over a two-year period of follow-up.~   "
246498|NCT00326664|"~     This phase I trial is studying the side effects and best dose of AZD2171 in treating young~     patients with recurrent, progressive, or refractory primary CNS tumors. AZD2171 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking~     blood flow to the tumor.~   "
246499|NCT00326651|"~     Patients will use the Conception Kit in their home and fill out a 22 question questionnaire~     in order to demonstrate their knowledge of the method of usage as described in the~     instructions and on the website: www.conceptionkit.com.~   "
246500|NCT00326638|"~     In this study we are comparing two forms of radiotherapy. This study is being done because it~     is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side~     effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).~   "
246501|NCT00326625|"~     Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under~     the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone®~     (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting~     multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and~     neuroprotective properties, which are believed to be of therapeutic value in ALS. The study~     treatment duration is 1 year (52 weeks).~   "
246502|NCT00326612|"~     The investigators will conduct a randomized controlled trial comparing the use of nasal~     midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute~     seizure activity in children under the age of 18 years with epilepsy in the community~     setting. The primary hypothesis is that nasal midazolam will be more effective and have~     shorter seizure time compared to rectal diazepam in the community. The secondary hypotheses~     are that patients treated with nasal midazolam will have fewer respiratory complications,~     emergency department visits, and admissions.~   "
246503|NCT00326599|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. Giving gemcitabine and carboplatin~     together with AZD2171 may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and~     carboplatin together with AZD2171 works compared to giving gemcitabine and carboplatin~     without AZD2171 as first-line therapy in treating patients with stage IIIB or stage IV~     non-small cell lung cancer.~   "
246504|NCT00326586|"~     This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant~     Prostate Cancer.~   "
246543|NCT00326066|"~     The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular~     micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed~     open-angle glaucoma and subjects diagnosed with Ocular hypertension.~   "
246505|NCT00326573|"~     The management of diabetes in adolescence presents significant difficulties due to~     psychological and physiological factors. Blood glucose control deteriorates in this age group~     and poor management threatens long-term health. Motivational Interviewing, a psychological~     intervention designed to facilitate behaviour change, has recently been used with a small~     group of teenagers, producing improved blood glucose control. To establish the impact of this~     intervention and its key components, we plan to compare the outcome in several clinics over a~     longer period of time in a larger number of adolescents selected at random to undergo~     motivational interviewing or to act as a control group. If successful this approach has~     potential to be incorporated into the routine clinical care of adolescents with diabetes.~   "
246506|NCT00326560|"~     Pterygium excision surgery involves excising the abnormal growth from the cornea and filling~     the defect with a conjunctival (white of the eye) graft from the superior part of the eye.~     This is the best method of pterygium excision but it is recognised that in 10-15% of cases it~     will grow back (recurrence). Currently the investigators use small sutures to sew the graft~     in place. Recently it has been described that glue can be used instead of the sutures. It has~     been shown in one study that the patient discomfort is less and so is the surgical time. The~     investigators want to confirm these findings and also compare the recurrence rate between the~     two types of surgery. They plan to complete a prospective, randomised, control trial of 40~     participants. Twenty will have traditional pterygium surgery with the conjunctival autograft~     sutured. Twenty will have cut and paste surgery with Tisseel glue. The two groups of~     participants will be compared for pain and discomfort, surgery time, and recurrence rate of~     the pterygia.~   "
246507|NCT00326534|"~     One study has suggested a connection between an infection with Rickettsia species and~     sarcoidosis finding molecular evidence of rickettsial deoxyribonucleic acid (DNA) in two~     patients. Another study found no antibodies in twenty Swedish patients with sarcoidosis.~      This study will further enhance the subject by three different approaches in Danish patients.~      The purpose of this study is to find serological and molecular evidence of an infection with~     Rickettsia species in Danish patients with sarcoidosis.~   "
246508|NCT00326521|"~     Briefly, the investigators propose to evaluate nulliparous (first time mothers) patients~     beyond 36 0/7 weeks' gestation in active labor who already have received epidural anesthesia~     and have an intrauterine pressure catheter (IUPC) in place. Any patient who then develops a~     single temperature elevation of > 38 degrees will be eligible for inclusion and consented for~     the study. Maternal blood will be drawn immediately, one hour later and at delivery. Amniotic~     fluid will be aspirated from the pressure catheter; the first 1-2 cc will be discarded and~     the remainder will be evaluated for gram stain, culture, glucose level, interleukin-6 (IL-6),~     and proteomics. All placentas will be sent for routine pathologic examination. Cord blood~     will be obtained at birth for routine studies. Both maternal and cord blood will be sent for~     proteomic evaluation (defined). The patients with amniotic fluid that has a positive gram~     stain and culture will be defined as the infected group, and the patients with amniotic fluid~     that has a negative gram stain and culture will be defined as the uninfected group.~     Differences in clinical presentation and laboratory assessments, including proteomics, will~     be compared between the two groups to determine if there are any markers that might prove to~     be useful in distinguishing between these two entities (epidural fever with and without~     actual infection).~   "
246509|NCT00326508|"~     This study will determine whether treatment with a combination of the drugs daclizumab and~     denileukin diftitox can eliminate the need for long-term daclizumab treatment in adult~     patients with uveitis. Denileukin diftitox kills white blood cells called lymphocytes that~     cause inflammation and may be the cause of uveitis.~      Patients 18 years of age and older with uveitis in one or both eyes who are on daclizumab~     therapy and have not had a disease flareup in 6 months may be eligible for this study.~     Candidates are screened with a medical history, physical examination, eye examination~     (including vision test, examination of the front of the eye, and pupil dilation for~     examination of the retina at the back of the eye), blood tests and a questionnaire about~     their vision and daily activities.~      After screening, participants undergo the following procedures:~        -  Daclizumab/ denileukin diftitox treatment. Patients receive their regular dose of~          daclizumab intravenously (through a vein). The interval between doses is increased by 1~          week after each dose. When the doses are 10 weeks apart, the daclizumab is stopped.~          Patients who experience a flare or uveitis are treated with intravenous denileukin~          diftitox and possibly local injections of steroids around the eye or increasing or~          adding other medicines as needed to control the uveitis.~        -  Fluorescein angiography to look for blood vessel abnormalities in the eyes. A yellow dye~          is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of~          the retina (the back portion of the eye) are taken with a special camera that flashes a~          blue light into the eye. The pictures show if any dye has leaked from the vessels into~          the retina, indicating possible abnormalities.~        -  Ultrasound and urine tests at enrollment and after 1 year to check kidneys, lymph nodes~          and pelvic area.~        -  Blood tests at enrollment and every 3-6 months for laboratory and immunology tests and~          other research tests on blood cells to examine the immune response.~        -  Follow-up visits approximately every 6 weeks for 2 years for repeat examinations to~          determine the response to treatment and drug side effects.~   "
246510|NCT00326495|"~     Background:~        -  Colorectal cancer (CRC) is a major public health problem in the U.S. and worldwide, and~          5-year survival with widespread metastatic disease is less than 5%.~        -  Expression of epidermal growth factor receptor (EGFR) or up-regulation of the gene~          occurs in the majority of CRC cases (60-80%).~        -  Therapies targeting EGFR, like cetuximab, have shown activity in the treatment of solid~          tumors like CRC.~        -  Cetuximab is FDA (Food and Drug Administration) approved for the treatment of~          EGFR-expressing CRC, but clinical responses to cetuximab are seen in only 10% of~          EGFR-expressing CRC.~        -  One possible mechanism of resistance to cetuximab could be KRAS (Kirsten rat sarcoma)~          mutations.~        -  Another major pathway implicated in colon carcinogenesis is the vascular endothelial~          growth factor (VEGF) pathway, which is involved in angiogenesis and is a validated~          target for therapy in CRC.~        -  BAY 43-9006 is both a Raf kinase inhibitor and an inhibitor of VEGF receptor (VEGFR2)~          tyrosine kinase.~        -  We hypothesize that the combined inhibition of EGFR, VEGFR2, and the Ras-(rapidly~          accelerated fibrosarcoma) Raf pathway will demonstrate promising clinical activity in~          CRC. Furthermore, in patients with mutant KRAS, combination of cetuximab with a drug~          that inhibits Raf kinase and acts downstream of Ras mutations, could restore tumor~          sensitivity to cetuximab.~      Objectives:~        -  To determine the rate of response (complete response (CR) + partial response (PR) +~          stable disease (SD) for 4 months) and toxicity profile of combination of BAY 43-9006 and~          cetuximab in previously treated EGFR-expressing metastatic CRC in patients with mutant~          KRAS.~        -  To evaluate BAY 43-9006 pharmacokinetics & pharmacogenomics (CYP3A4/5 (cytochrome P450~          3A4/5)).~        -  To evaluate for this combination treatment pharmacodynamics, effect on tumor vascularity~          and effect on angiogenic cytokines.~      Eligibility:~        -  Adults with histologically or cytologically documented, measurable, EGFR-expressing~          metastatic CRC, which has recurred or progressed following at least one prior 5FU~          (Fluorouracil)-based combination chemotherapy regimen administered for the treatment of~          metastatic disease.~        -  Patients must be KRAS mutation-positive.~      Design:~        -  BAY 43-9006 will be administered 400 mg by mouth twice daily~        -  Cetuximab will be administered as 400 mg/m^2 loading dose (week 1) followed by 250~          mg/m^2 IV (intravenous) weekly.~        -  If procedure may be performed safely, tumor biopsy will be obtained prior to treatment~          and after 4 weeks of treatment.~        -  Optional positron emission tomography (PET)/computerized tomography (CT) imaging with~          89Zr-labeled, EGFR-targeting antibody panitumumab may be performed to evaluate radiation~          dosimetry, safety, and tumor distribution prior to and following treatment with study~          agents.~        -  Patients will be evaluated for response every 8 weeks using the RECIST (Response~          Evaluation Criteria in Solid Tumors) criteria.~        -  This trial uses a phase II optimal design targeting a response rate as defined above of~          20% in patients with mutant KRAS. Up to 49 patients may be treated.~   "
246511|NCT00326482|"~     This study will provide a basis for research on the impact of liver injury caused by~     antiretroviral therapy in HIV-infected patients. Elevated liver enzymes called AST and ALT~     are common in HIV-infected patients taking antiretroviral medications and can indicate liver~     damage. Although there are a number of possible causes for these elevations, such as~     infections with a hepatitis virus, antiretroviral medications alone can lead to the~     elevations. The study will focus particularly on evidence of liver fibrosis, which is a sign~     of progressive liver damage.~      HIV-infected patients 18 and older who 1) have been taking combination antiretroviral therapy~     for at least 12 months and have been on a stable regimen for at least 3 months, and 2) have~     had elevated AST or ALT levels for at least 6 months may be eligible for this study. Patients~     who have had liver biopsies performed in the past may be eligible for participation.~      Participants undergo the following tests and procedures over a 12-month period:~        -  Oral glucose tolerance test: The patient drinks a glucose (sugar) drink. Blood samples~          are then drawn over 2 hours through an intravenous (IV) line in the patient's arm. This~          test measures how high the patient's blood sugar and insulin levels rise after drinking~          a standard glucose load.~        -  Transient elastography: This ultrasound test uses vibration (sound waves) to measure~          liver stiffness (fibrosis). Vibrations move faster through a fibrotic liver.~        -  Triple-phase CT scan and single slice CT scan of L4-5: Patients fast for 4 hours before~          the CT scan. A contrast material is injected through a catheter placed in an arm vein to~          improve the visibility of the liver in the specialized X-ray images obtained in the CT~          scanner.~        -  Liver biopsy: This test removes a small sample of liver tissue for microscopic~          examination, particularly for evidence of fibrosis. The skin over the biopsy site is~          numbed and a needle is passed through the skin and rapidly in and out of the liver.~          Patients may be given a sedative for the procedure.~        -  Follow-up visits. Patients return for follow-up visits 1 to 4 weeks after the liver~          biopsy and three more times over the course of the study for a medical history, physical~          examination and blood tests.~      Patients may participate in an additional 4-year follow-up, during which they have visits~     every 3-12 months and are offered the opportunity to repeat the biopsy no sooner than 1 year~     after the first biopsy.~   "
246512|NCT00326469|"~     To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be~     treated with either surgery or chemotherapy at the moment of study inclusion, the efficacy of~     lanreotide Autogel in tumour growth stabilization.~   "
246544|NCT00326053|"~     The purpose of this study is to compare the Symbicort® Turbuhaler® to both Pulmicort®~     Turbuhaler® and Bricanyl® Turbuhaler® for the treatment of asthma after discharge from the~     emergency room~   "
246513|NCT00326456|"~     The purpose of this study is to compare the effectiveness (progression free survival) of the~     experimental combination of carboplatin + liposomal doxorubicin with the standard combination~     of carboplatin + paclitaxel in first line treatment of patients with ovarian cancer.~      Secondary objectives are to evaluate overall survival, quality of life, objective response~     rate, and toxicity.~   "
246514|NCT00326443|"~     The purpose of this research study is to see if giving a typhoid vaccine by mouth (an~     experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a~     better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see~     whether CVD 909 is safe. Typhim Vi has been shown to be safe and effective in preventing~     typhoid fever in older children and adults, but it does not work in children under age 2.~     Scientists at the University of Maryland think that young children could respond to Typhim Vi~     if they were given a dose of the other typhoid vaccine by mouth before they are given the~     Typhim Vi shot. Twenty-eight healthy adult volunteers, ages 18-40 years, will take part in~     this study. Study participation will last for up to 63 weeks, but most of the study visits~     will be in the first 6 weeks. Blood samples will be collected approximately 13 times. Four~     stool samples will be collected. Some volunteers may be followed for an additional 4 years.~   "
246515|NCT00326430|"~     The purpose of this study is twofold: (1) to compare the effectiveness of two promising~     treatments for social phobia, a new cognitive therapy model (Clark & Wells, 1995; Borge et~     al., 2001) and interpersonal therapy (Lipsitz, Markowitz, & Cherry, 1997), adapted for~     inpatient groups; and (2) to study the empirical change processes in these therapies and~     compare them with the cognitive and interpersonal models of change.~   "
246516|NCT00326417|"~     The purpose of the current study is to continue to optimize conditioning regimens in~     high-risk patients with severe aplastic anemia transplanted with marrow from HLA-compatible~     unrelated donors. Specifically, the study will determine whether the addition of fludarabine~     to the conditioning regimen previously described by Deeg et al. will permit a reduction in~     the CY dose, to a point where sustained hematopoietic engraftment and survival are maintained~     (or improved), while the frequency of major regimen-related toxicity (RRT) and early deaths~     is reduced.~   "
246517|NCT00326404|"~     The primary purpose of this study is to compare the compliance rates of adolescents who take~     oral contraceptives (OCPs) continuously to those who take OCPs cyclically.~   "
246518|NCT00326391|"~     The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl~     extended-release tablets at five dose levels compared to placebo in adults with Attention~     Deficit Hyperactivity Disorder (ADHD)~   "
246519|NCT00326378|"~     Non-Small Cell Lung Cancer(NSCLC) is the leading cause of death in Korean men after stomach~     cancer. Surgical resection plays a main role for curative treatment. However, less than 20 %~     of the NSCLC patients have been found in stage I-II disease. In inoperable stage IIIA/B~     disease, the recommended treatment is combined chemotherapy and radiation therapy. Various~     kinds of combination of 2 modalities have been used either in sequential or concurrent~     setting. Concurrent chemoradiotherapy(CCRT) have been recognized to have better survival than~     radiation therapy alone or sequential therapy, but additional consolidation chemotherapy~     after CCRT is not yet to be determined for the beneficial role in survival gain. Docetaxel is~     an anticancer drug and has synergistic anticancer effect in various cancer with cisplatin,~     another anticancer drug. In the present study, randomised trial will be performed to confirm~     the efficacy of the consolidation chemotherapy with docetaxel and cisplatin after completing~     CCRT with the same chemotherapeutic agents in stage III inoperable NSCLC on progression free~     survival and overall survival.~   "
246520|NCT00326365|"~     The purpose of this study is to determine whether the homeopathic remedy Kali Bichromium is~     effective in reducing the amount of tracheal secretions in patients intubated with a~     conventional endotracheal tube and receiving controlled mechanical ventilation in the ICU~     setting.~   "
246521|NCT00326352|"~     For reduction of dislocated shoulder, sedation with propofol and remifentanil should give~     satisfactory operating conditions and pain relief, and significantly reduce the time to full~     recovery, compared with morphine and midazolam~   "
246522|NCT00326339|"~     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, ascending~     dose, dose ranging study to evaluate up to three doses of R935788 (50 mg bid, 100 mg bid and~     150 mg bid). Approximately 180 patients who have had rheumatoid arthritis for a minimum of 12~     months and who have been receiving a weekly methotrexate (MTX) dose for a minimum of 6 months~     will be enrolled into the study.~   "
246523|NCT00326326|"~     To assess the effect of CP-778,875 on HDL-C cholesterol in adult subjects with dyslipidemia~     and type 2 diabetes~   "
246524|NCT00326313|"~     Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It~     can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in~     preterm babies.~      During the past two decade, the introduction of protocols for prophylactic antibiotics for~     women with a high risk for GBS infection, have led to a decline of 65% in GBS cases(0.32 for~     1000 live birth compared to 1.8 cases in 1000).The purpose of the study is to check the~     morbidity and mortality at Sheba medical center in the last 12 years in children with~     positive blood culture for GBS. We assume that in our hospital the morbidity and mortality is~     less then expected. If proven right, we would then check the reasons for that outcome~     considering the type and length of treatment and the different virulence of the~     streptococcus.~   "
246525|NCT00326300|"~     The purpose of this study is to evaluate the long-term safety of methylphenidate HCL~     extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity~     Disorder (ADHD)~   "
246526|NCT00326287|"~     The purpose of this study is to compare the clinical cure rate (ratio of clinically cured~     patients to the total number of patients) of ceftobiprole medocaril versus a comparator in~     the treatment of patients with community-acquired pneumonia.~   "
246527|NCT00326274|"~     The purpose of this study is to determine the safety potential of Helioblock® SX Cream as a~     sunscreen product in long term intermittent use conditions among pediatric subjects.. Each~     subject will be enrolled to participate for six months. The test product should be applied~     every day that outdoor activities are planned, prior to any significant sun exposure during~     out-door activities (such as the beach, outdoor sport activities), or whenever the subject~     needs to be protected against sunburn or other damage due to the sun. A minimum of 14 days~     test product use and sun exposure is required.~   "
246528|NCT00326261|"~     Nerve blocks for arm and hand surgery provide many advantages for patients including~     excellent pain control and reduction in general anesthesia-related adverse effects.~     Infraclavicular block is possibly the best method for performing regional anesthesia of the~     arm because of the consistent anesthesia of the whole arm and low incidence of serious~     adverse effects. Normally the anesthetist uses nerve stimulation to identify nerves supplying~     the forearm and hand. Recent research has indicated that to improve success from 60% to 79%~     two types of muscle stimulation must be sought before injection of local anesthetic. This can~     be time consuming, requires a significant learning process, increases complications and~     leaves 21% of patients with inadequate anesthesia requiring supplementation or general~     anesthesia. More recently practitioners have been using ultrasound imaging to direct the~     needle and watch local anesthetic spread around the nerves. Preliminary reports have~     documented that this technique is associated with much greater success than the nerve~     stimulation method. However a good quality study comparing the dual-endpoint infraclavicular~     technique with an ultrasound-guided technique has not been performed. This randomized study~     aims to rectify this deficiency by determining if ultrasound-guided infraclavicular block has~     a significantly greater success than the current standard, dual end-endpoint nerve~     stimulation technique.~   "
246529|NCT00326248|"~     This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will~     significantly decrease the number of patients who experience nausea and vomiting after~     surgery.~   "
246530|NCT00326235|"~     Dependence on heroin is a major public health problem because of its association with~     criminality, law enforcement costs and healthcare costs. Managed withdrawal is a required~     first step for a long term drug-free treatment of heroin addicts. Methadone and clonidine~     have been the mainstay of treatment for the relief of heroin withdrawal symptoms but both~     have limitations. The purpose of this study was to evaluate the efficacy of buspirone in the~     alleviation of the withdrawal symptoms experienced by heroin addicts when they stop using~     heroin. Buspirone is a non opiate drug with no abuse potential, no sedating effects and no~     withdrawal symptoms.~   "
246531|NCT00326222|"~     The purpose of this randomised open study is to examine the effect of self-management program~     for diabetes patients.~   "
246532|NCT00326209|"~     To evaluate the long-term safety and tolerability of mesalamine pellets (MP)in patients with~     ulcerative colitis currently in remission.~   "
246533|NCT00326196|"~     This is a randomized, multi-site, clinical trial comparing percutaneous coronary stenting~     (PCI) with drug eluding stents to coronary bypass for angiographically significant coronary~     artery disease in diabetes. The hypothesis being tested is that a strategy of surgical~     revascularization is superior to percutaneous intervention in preventing death or myocardial~     infarction in diabetics with severe ischemic heart disease.~   "
246534|NCT00326183|"~     Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella~     [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data~     will be collected following each vaccination.~   "
246535|NCT00326170|"~     5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS).~     Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the~     effects of 5-aza. The goal of this clinical research study is to find the highest safe dose~     of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and~     all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness~     of this combination therapy will also be studied.~      Additional blood and bone marrow samples will be requested. These samples will be used to~     evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and~     bone marrow samples that are collected at the start of the study and during the regularly~     scheduled evaluations to be sent for research studies. The research studies will examine~     changes in the blood and bone marrow cells that might help explain the causes of leukemia and~     MDS and how the combination of 5-aza, VPA, and ATRA works.~   "
246536|NCT00326157|"~     This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome®~     loading dose regimen, in a weekly administration schedule during the initial phase of~     allogeneic stem-cell transplant and in case of occurrence of graft versus host disease~     (GvHD), which are both high risk periods as far as severe fungal infection development is~     concerned.~   "
246537|NCT00326144|"~     The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate~     sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the~     treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the~     same formulation. The SR designation was changed to XR after consultation with FDA.~   "
246538|NCT00326131|"~     The first purpose of this study is to determine how the body absorbs, metabolizes, and~     eliminates a single dose of BMS-275183 (labeled with radioactive carbon). Secondly, to~     measure the levels of BMS-275183 in your blood, study the safety of the drug, and to see what~     effects it has on your cancer.~   "
246539|NCT00326118|"~     The purpose of the primary phase of the study is to demonstrate the non-inferiority of a~     single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC)~     conjugate vaccine when given in the second year of life to subjects primed in infancy with a~     Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available~     Hib and MenC vaccines.~      In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to~     follow the antibody persistence up to 5 years after vaccination. No additional vaccine is~     administered during the extension phase. The Protocol Posting has been updated in order to~     comply with the FDA Amendment Act, Sep 2007.~   "
246540|NCT00326105|"~     The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an~     antidepressant versus an antidepressant alone in patients with MDD with inadequate response~     to an antidepressant treatment.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
246541|NCT00326092|"~     The purpose of this study is to assess the comfort of a glaucoma therapy in patients with~     open-angle glaucoma or ocular hypertension~   "
246542|NCT00326079|"~     The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular~     micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle~     glaucoma.~   "
246546|NCT00326027|"~     The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in~     hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux~     disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a~     patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration~     consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered~     once daily in the morning to patients with NERD or GERD at one dose level for each~     indication. The study will provide further data on the safety and tolerability of~     pantoprazole.~   "
246547|NCT00326014|"~     To evaluate the safety and efficacy of a new trabecular bypass that is implanted in~     conjunction with cataract surgery in open angle glaucoma subjects.~   "
246548|NCT00326001|"~     The purpose of this study is to demonstrate the advantage of using a gold alloy tip electrode~     over a platinum/iridium alloy tip electrode in ablation of the cavotricuspid isthmus in~     patients with atrial flutter.~   "
246549|NCT00325988|"~     This study will identify biomarkers (genes and proteins) in patients with relapsing-remitting~     multiple sclerosis (MS) and link them with clinical disease parameters, such as the extent of~     inflammation and rate of disease progression, to try to better understand the disease. It~     will examine how the biomarkers may be related to disease development and progression and~     differences among patients' symptoms and response to treatment.~      Patients with relapsing-remitting MS between 18 and 60 years of age who are enrolled in the~     multi-institutional MS-CombiRx trial may be eligible for this sub-study. Participants have~     blood tests when they enter the MS-CombiRx study and again after 6 months, 1 year, and 3~     years for analysis for genetic and protein analysis.~   "
246550|NCT00325975|"~     This study will examine how people s immune systems respond to inoculation with vaccinia~     virus the standard vaccine used to protect against smallpox and how these responses correlate~     with symptoms they develop after receiving the vaccine.~      People 18 years of age and older who are scheduled to receive smallpox vaccination as a~     routine part of their employment (e.g., laboratory worker, health care worker, or emergency~     response worker) may be eligible for this study. They may or may not have been vaccinated~     previously. In addition, individuals who were vaccinated against smallpox at least 6 months~     before starting the study may participate as control subjects. All candidates will be~     screened with a brief medical history and physical examination.~      Participants in the following vaccination categories will undergo the procedures described~     for their group:~      Vaccine Recipient Frequent Follow-up~      Participants will come to the NIH Clinical Center every 2 to 3 days for a total of 7 visits~     over a 2-week period. At each visit, starting the day of vaccination, they will have the~     following procedures:~        -  Brief skin examination, possibly with photographs of skin lesions;~        -  Throat and skin swabs for vaccinia virus culture;~        -  Blood draw (about 8 teaspoonfuls).~      Additional blood samples will be collected 1 month after vaccination and again within a year~     after vaccination. The blood will be analyzed for the immune response to the vaccine, genetic~     differences that might influence differences in immune response, and the presence of vaccinia~     virus.~      Participants will fill out a diary card every day for 3 weeks after vaccination to record any~     symptoms. Individuals who develop symptoms lasting more than 2 weeks, such as persistent or~     new skin lesions, will return to the clinic for additional skin exams and blood tests.~     Individuals who develop vaccine side effects may have a urine culture for vaccinia virus.~      Vaccine Recipient Infrequent Follow-up~      Participants will come to the NIH Clinical Center for blood tests on the day of vaccination,~     4 weeks after vaccination, and once again within a year after vaccination. At each visit, 6~     teaspoonfuls of blood will be drawn. This group will also include individuals who have been~     vaccinated within 8 months of entering the study and are not currently receiving the vaccine,~     but for whom blood samples are not available.~      Control Group Vaccinated at Least 6 Months Before Entering the Study~      Participants will come to the NIH Clinical Center for blood tests every 2 to 3 days for 2~     weeks, then at 1 month after the first blood draw, and again within a year of the first blood~     draw. About 8 teaspoonfuls of blood will be drawn at each visit.~   "
246551|NCT00325962|"~     The purpose of this study is to determine whether 6R-BH4 (sapropterin dihydrochloride) is~     safe and effective in the treatment of poorly controlled hypertension in the presence or~     absence of type 2 diabetes.~   "
246552|NCT00325949|"~     This is a study of the safety and pain-relieving ability of extended release hydrocodone and~     acetaminophen tablets in patients with moderate to severe low back pain~   "
246553|NCT00325936|"~     Abnormalities of glucose, insulin and lipoprotein metabolism are common in patients with~     hypertension, and these metabolic abnormalities are reported to be related to insulin~     resistance. Therefore, whenever treating such patients, antihypertensive agents that may have~     the added effect of improving insulin resistance should be selected. CinalongTM (Cilnidipine)~     is expected to improve metabolic syndrome as well as insulin resistance by its dual effects~     on L and N-type calcium (Ca) channels. In this study, the researchers investigate the effects~     of CinalongTM on insulin resistance and other metabolic related factors.~   "
246554|NCT00325923|"~     The aim of this study is to assess the impact of a patient decision aid regarding natural~     health products for menopausal symptoms on decisional conflict, knowledge and persistence for~     an option of women aged 45-64 years old. We are expecting a decrease in decisional conflict~     and an improvement on knowledge level. We are also expecting an intention to use the decision~     aid in the future and to discuss with the physician or pharmacist about the use, or the~     intention to use natural health products.~   "
246555|NCT00325910|"~     To conduct a pilot study to evaluate the feasibility of a large randomized controlled trial~     (RCT) of metformin in patients with heart failure and type 2 diabetes and to generate initial~     morbidity and mortality estimates in this patient population. The primary hypothesis is that~     subjects with heart failure and type 2 diabetes who receive metformin will have a significant~     reduction in the combined endpoint of all-cause mortality and all-cause hospitalization as~     compared to subjects who receive placebo therapy.~   "
246556|NCT00325897|"~     The purpose of this study is to determine if long-term administration of a macrolide~     antibiotic will reduce worsening of symptoms among individuals with chronic obstructive~     pulmonary disease (COPD).~   "
246557|NCT00325884|"~     The purpose of this study is to assess the long-term clinical outcomes after stenting~     bifurcation coronary artery lesions, and to determine whether simple or more complex~     techniques are associated with a better clinical outcome. We will also assess the risk~     factors associated with poorer clinical outcomes~   "
246571|NCT00325702|"~     This project will develop, implement, and evaluate a community-level intervention for Black~     and White substance-using MSM between the ages of 15 and 29. The intervention is designed to~     change both social norms and risk behavior using persuasive media communication and~     interpersonal networking as primary intervention strategies.~      Qualitative data from focus groups and interviews will inform the development of the~     intervention. The effects of the intervention will be assessed through annual interviews with~     young Black and White MSM in Philadelphia where the intervention will be implemented and in~     Baltimore, our comparison community.~   "
246572|NCT00325689|"~     A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with~     Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic~     treatment.~   "
247023|NCT00319670|"~     To evaluate patient acceptance of a new MiraLax dose formulation in children currently~     treated with polyethylene glycol 3350 powder for treatment of constipation.~   "
246558|NCT00325871|"~     Colorectal cancer (CRC) is one of the common malignancies worldwide, accounting for a~     significant percentage of cancer mortality. Concurrent chemoradiation (CCRT) is now a~     standard treatment for unresectable malignancies of anorectum. To improve quality of life,~     CCRT is also commonly applied in treatment of lower rectal and anal canal cancer to preserve~     anal sphincter function. The most commonly used chemotherapeutic drugs combined with~     radiation as radiosensitizers is 5-fluorouracil (5-FU). Circulating endothelial progenitor~     cells (EPC), which contribute to the tumor vessel formation, reflect the response to~     chemotherapy both in animal model and clinical trial. Thus, circulating EPC can be used as a~     marker for optimizing and monitoring the anti-angiogenesis therapy including angiogenesis~     inhibitors and chemotherapy. Whether circulating EPC can be served as a marker of CCRT~     efficacy or not remains undetermined. Since CCRT is now a standard treatment of locally~     advanced and high-risk CRC, the development of a surrogate marker for monitoring CCRT~     response and optimize treatment intensity is very important.~      In this grant we intent to monitor the levels of circulating EPC in locally advanced and~     high-risk CRC patients before, during and after CCRT. To further characterize the changes in~     function and biology of EPC caused by CCRT, a syngeneic animal model will be also used to~     evaluate the clonogenecity and specific gene expression of EPC in tumor-bearing mice~     receiving CCRT.~   "
246559|NCT00325858|"~     The purpose of this study is to compare the effectiveness of multiple doses of once daily~     tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe~     pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the~     treatment of patients with moderate to severe pain due to OA.~   "
246560|NCT00325845|"~     The objective of this investigation is to evaluate the safety and efficacy of~     viscosupplementation in treating symptomatic lumbar facet joint arthropathy. The intended use~     of the device (Synvisc) is to alleviate pain and improve function in patients with painful~     lumbar facet joint arthrosis by intra-articular injection into the involved joint.~   "
246561|NCT00325832|"~     To determine if the use of automated office blood pressure readings can improve management of~     systolic hypertension in routine clinical practice. Automated office SBP recordings in~     routine clinical practice using the BpTRU device will reflect more accurately the mean awake~     ambulatory systolic BP than will manual BP readings taken with conventional mercury~     sphygmomanometry. This should lead to improvements in the management of systolic hypertension~     with optimization of drug therapy in practices using the BpTRU device.~   "
246562|NCT00325819|"~     The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol)~     for routine infant vaccinations is helpful in preventing fever or other symptoms.~   "
246563|NCT00325806|"~     Primary objective:~      Mean values of systolic and diastolic office blood pressure~      Secondary objectives:~      Total mortality, occurrence of cardio- and cerebrovascular events, change of mean blood~     pressure (ABPM : Ambulatory Blood Pressure Monitoring) during the observation~   "
246564|NCT00325793|"~     Hypertension (high blood pressure) can often cause neurological worsening in patients with~     stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of~     nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of~     Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The~     purpose of this study is to evaluate safety and efficacy of double or triple concentrated~     peripheral intravenous (IV) Nicardipine.~   "
246565|NCT00325780|"~     This study is a long-term follow-up protocol for patients who participated in study~     NK-104-3.01EU or study NK-104-3.02EU.~   "
246566|NCT00325767|"~     The purpose of this study is to determine whether lung mucociliary clearance (MCC) can be~     significantly enhanced in healthy subjects by one week of inhalation of nebulized~     levalbuterol aerosol, as compared to racemic albuterol or placebo. Subjects will inhale one~     week of levalbuterol, one week of racemic albuterol, and one week of placebo, in a randomized~     order.~   "
246567|NCT00325754|"~     Chronic Obstructive Pulmonary Disease (COPD) affects over 14 million people in the United~     States. It is the fourth leading cause of death and the only leading cause of death for which~     mortality rates are rising. Medical science has developed few effective therapies for COPD.~     In patients with advanced COPD and chronic hypoxemia, long-term oxygen therapy (LTOT) has~     been shown to be uniquely beneficial. It is the only available non-surgical therapy~     demonstrated to prolong survival in these patients. This study will compare the clinical and~     physiologic benefits of two different oxygen therapy devices among hypoxemic individuals with~     COPD: a lightweight ambulatory oxygen device versus the standard portable E-cylinder device.~   "
246568|NCT00325741|"~     The Stanford Medical Center Division of Immunology and Rheumatology and the Division of Blood~     and Marrow Transplantation (BMT) are enrolling patients with severe systemic lupus~     erythematosus (SLE) that is resistant to standard treatment (prednisone and cyclophosphamide~     [Cytoxan]) into a new study to determine if they can be successfully treated with a blood~     stem cell transplantation obtained from an appropriate donor. Donors will be human leukocyte~     antigen (HLA)-matched healthy brothers or sisters. For patients without sibling HLA-matches,~     a search for donors will be initiated through the US and International Donor Registries.~     Eligible patients must be at least 18 years old and have SLE with progressive kidney, lung,~     heart, or central nervous system disease that has not responded to standard therapy.~      Patients will be treated for two weeks to prepare them for the infusion of blood stem cells~     that are obtained from their HLA-matched donor. Patients will initially be treated with~     immunosuppressive drugs, which will be gradually withdrawn at approximately 6 months after~     transplantation. The goal of this study is to replace the abnormal immune cells of the SLE~     affected patient that causes the disease with normal immune cells that are generated from the~     transplant blood stem cells from the healthy donor.~   "
246569|NCT00325728|"~     The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in~     subjects with mild to moderate Alzheimer's Disease and sleep disturbance~   "
246570|NCT00325715|"~     AGN 201904, a proton pump inhibitor, versus esomeprazole in the prevention of stomach or~     upper intestinal damage following administration of high-dose aspirin in healthy volunteers~   "
246636|NCT00324818|"~     We are trying to determine if longer duration of therapy with metronidazole or combination~     therapy of metronidazole plus azithromycin results in better cure rates for BV~   "
246573|NCT00325676|"~     The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study~     discontinuation rates, and quality of life parameters in patients with erosive GERD. The~     study duration consists of a treatment period up to 16 weeks according to the classical~     healing concept or the complete remission concept. During this period, the patients will~     receive pantoprazole (tablet) at one dose level once daily. The following observational phase~     lasts up to 6 months. The study will provide further data on efficacy, safety, and~     tolerability of pantoprazole.~   "
246574|NCT00325663|"~     The aim of this study was to evalute three different acupuncture techniques, including one~     sham control, in its effect on osteoarthitis of the knee~   "
246575|NCT00325650|"~     Primary objective:~      To evaluate the effect of long-term administration of Rimonabant on the time of progression~     to type 2 diabetes in patients with prediabetes (i.e. Impaired Fasting Glucose (IFG) or~     Impaired Glucose Tolerance (IGT) or both at baseline).~      Secondary objectives:~        -  To assess the effect on weight loss and weight maintenance; sustained effect following a~          washout period, effect on other markers of glycemic control (fasting glucose,~          fasting-insulin and HbA1c), glucose tolerance and insulin responses during oral glucose~          tolerance tests (OGTTs), and on other risk factors (HDL-Cholesterol, TG),~        -  To assess the effect on quality of life~        -  To evaluate long term safety and tolerability.~   "
246576|NCT00325637|"~     The purpose of this study is to compare the effect of cilnidipine (a calcium channel blocker)~     and losartan (an angiotensin II receptor blocker) on cerebral blood flow (CBF) and blood~     pressure in hypertensive patients with a previous ischemic stroke.~   "
246577|NCT00325624|"~     The purpose behind the proposed research is that diabetes care in First Nations people can be~     improved by involvement of a Home Care team providing diabetes education and management,~     supported by emerging technology, specifically Bluetooth-enabled glucometers and blood~     pressure monitors, capable of transmitting their data to a web environment in tabulated and~     graphical format available for remote viewing.~   "
246578|NCT00325611|"~     Palliative care is believed to improve care of patients with life-limiting illnesses. This~     study evaluated the impact of a multi-center randomized trial of a palliative care team~     intervention on the quality and cost of care of hospitalized patients. Study subjects were~     randomized to intervention or usual care. At study end, patients receiving the palliative~     care intervention reported greater patient satisfaction with their care. Intervention~     patients also had significantly fewer ICU admissions and lower total costs for care 6 months~     past their hospitalization. Intervention patients completed more advance directives and had~     longer hospice stays.~   "
246579|NCT00325598|"~     This study investigates the feasibility and safety of delivering radiation therapy only to~     part of the breast, (the tumor bed and selected areas) rather than the whole breast, for~     patients with early stage breast cancer.~   "
246580|NCT00325585|"~     Recent studies have shown that many drug-using minority women are vulnerable to HIV infection~     from their husbands or other intimate male partners. The goal of this study is to develop and~     evaluate two new HIV counseling and testing programs designed for drug-using women at risk~     for HIV from a primary male partner. It is predicted that HIV counseling and testing programs~     administered to couples rather than to women only, and programs that focus on intimate~     relationships in the context of HIV risk, will result in a reduction of risky sexual and~     drug-related behavior among drug-using women and their primary male partners. This four-year~     study employs a randomized clinical trial (RCT) design to test the effectiveness of two new~     HIV counseling and testing programs for women drug-users in Harlem and the South Bronx in New~     York City.~   "
246581|NCT00325572|"~     There are two phases to the study. The first will examine serum copper and zinc levels and~     copper/zinc ratio in children (ages 3-8) who have autism and compare them to levels from same~     sex and age children who are developing typically. The hypothesis is that there is a~     significant difference in the copper/zinc ratio between young children who have autism and~     their typically developing peers.~      The second phase of the study will evaluate the effect of dietary supplementation using zinc~     and vitamin C for 16 weeks on selected symptoms of autism. Children with autism will be~     enrolled on the basis of copper/zinc ratios greater than 2.0, and as determined to be~     statistically higher than typically developing children. Measurements of serum copper, zinc~     and unbound copper will be obtained prior to, at the mid-point and end of the trial. Those~     children whose ratios have not fallen below 1.25, the top of thecurrently recognized range~     will have the zinc and vitamin C doses adjusted for the duration of the trial. Detailed~     evaluation of language skills, and a variety of behaviors will be evaluated prior to and~     after supplementation. The study will be placebo-controlled and double blind. Those children~     enrolled in the placebo arm will be offered a full trial of supplements at the end of the~     their participation in the study.~      The hypothesis to be tested is whether correction of elevated copper to zinc ratios in~     children with autism can be accomplished by oral supplementation with zinc and vitamin C and~     if these children show measurable and significant changes in receptive or expressive language~     or behavioral parameters associated with autism.~   "
246582|NCT00325559|"~     This study aims at investigating the effect of hyperglycaemia on physical performance and~     local energy stores in the muscle in patients with type 1 diabetes mellitus under exercise~     conditions.~   "
246583|NCT00325546|"~     Primary : effect on weight loss and weight maintenance over 9 months when prescribed with a~     hypocaloric diet in obese patients.~      Secondary : effect on HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist~     circumference - safety and tolerability~   "
246584|NCT00325533|"~     Black men in the United States have a greater risk of developing high blood pressure than men~     of any other ethnic or racial group. The purpose of this study is to evaluate the~     effectiveness of a high blood pressure detection and medical referral program conducted by~     barbers in predominantly Black barbershops at increasing awareness and lowering blood~     pressure levels among their Black male customers.~   "
246585|NCT00325520|"~     The purpose of this study is to investigate thought processes and neural mechanisms that may~     contribute to the development of habitual behaviors. The investigators hypothesize that~     patients with AN will perform differently than people without eating disorders on a series of~     neuropsychological tasks and will show different neural activation patterns in functional~     neuroimaging scans.~   "
246586|NCT00325507|"~     The purpose of this study is to assess the safety and tolerability of TroVax® investigational~     vaccine injections when given as first or second line treatment in conjunction with~     subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or~     papillary cell renal carcinoma.~      TroVax® is the experimental product in this trial and its value as a medicine has not yet~     been proven. Interleukin-2 (IL-2) is a standard treatment for cancer, which means that it can~     be received even if one chooses not to participate in this study. TroVax® is being studied as~     a possible treatment for patients with cancer of the kidney.~      TroVax® belongs to a class of medicines called vaccines. A vaccine helps the body's immune~     system to recognize and kill foreign invading organisms effectively. It is believed that one~     of the reasons why cancer can spread through the body is that the immune system cannot~     recognize cancer cells as being different from normal tissues and therefore cannot kill the~     cancer cells. A vaccine that alerts the immune system to the presence of cancer cells in the~     body could lead to the immune system being able to target and kill those cancer cells~     effectively. This trial is of a completely new way of trying to treat cancer in the future by~     the use of vaccination injections. TroVax® consists of a virus that has been changed so that~     it is no longer infectious and carries a gene for a protein called 5T4. This protein is~     carried by many kidney cancer cells. When the virus is injected, it makes the protein, and~     the body's immune system is then able to recognize this protein and kill the cells that have~     it (i.e. the cancer cells).~      The purpose of this study is to assess the safety and tolerability of TroVax® injections and~     to understand whether TroVax® could make such an immune response happen in patients with~     renal cell cancer while receiving interleukin-2 (IL-2). This study will also observe and~     monitor any side effects experienced in patients who receive TroVax® while being treated with~     IL-2.~   "
246587|NCT00325494|"~     The purpose of this study is to establish the safest doses of an investigational drug called~     MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or~     lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface~     of these cancers.~   "
246588|NCT00325481|"~     To assess the safety of a bivalent vaccine of two new influenza virus reassortants in healthy~     adults prior to the release of the trivalent vaccine (FluMist) containing them.~   "
246589|NCT00325468|"~     An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab~     Administration in Postmenopausal Women with Low Bone Mineral Density~   "
246590|NCT00325455|"~     To assess the cholesterol changing effects of MK0859 in patients with primary~     hypercholesterolemia or mixed dyslipidemia.~   "
246591|NCT00325442|"~     This study was an international, multi-center, randomized, double-blind, placebo-controlled~     study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e.,~     endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred~     at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test.~     Study procedures included routine blood tests, medical history, physical exams, disease~     evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select~     centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.~      Patients who completed all assessments for 16-weeks were also eligible to enter an~     open-label, extension phase study (FREEDOM - EXT).~   "
246592|NCT00325429|"~     This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic~     agent. This 52-week clinical study is designed as an open label, long-term study aimed to~     evaluate the safety of vildagliptin in patients with type 2 diabetes.~   "
246593|NCT00325416|"~     The purpose of this research study is to determine the safest dose of topotecan when given in~     a high dose before a stem cell transplant; topotecan will be given with melphalan.~   "
246594|NCT00325403|"~     This study was an international, multicenter, randomized (2:1 active:placebo), double-blind,~     placebo-controlled study in subjects with PAH who were NOT currently receiving approved~     therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an~     additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test.~     Study procedures included routine blood tests, medical history, physical exams, disease~     evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at~     select centers - a hemodynamic substudy with a right heart catheterization at Baseline and~     Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and~     Week 12.~      Patients who completed all assessments for 12 weeks were also eligible to enter an~     open-label, extension phase study (FREEDOM - EXT).~   "
246595|NCT00325390|"~     To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance~     dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients~     with acute coronary syndrome without ST-segment elevation and planned for percutaneous~     coronary intervention(including stenting).~   "
246596|NCT00325377|"~     The purpose of this study is to test whether or not the Magnetic Molecular Energizer (MME)~     device provides a well tolerated and effective intervention to reduce pain, pain-related~     symptoms and improve ability to function in those diagnosed with the condition “Chronic Low~     Back Pain” (chronic LBP).~   "
246597|NCT00325364|"~     This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the~     Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking~     patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month~     follow-up period.~   "
246598|NCT00325351|"~     The purpose of this study is to evaluate whether treatment with a new drug called~     ZK-Epothilone (ZK-Epo) given with carboplatin in patients with recurrent ovarian cancer, who~     previously have had a good response with cisplatin or carboplatin, is safe and helps to~     decrease or stop tumor growth.~   "
246599|NCT00325338|"~     Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for~     patients with hypersensitivity to ragweed pollen (hay fever). This novel formulation is~     designed to provide a vaccine that will be efficacious with only four escalating dose~     injections administered before the start of the pollen season. In this Follow-up Study the~     Efficacy will be assessed by exposing allergic subjects to Ragweed pollen in an environmental~     exposure chamber EEC. Patient symptomatic response to pollen and patient quality of life in~     the EEC will be determined. Patients who previously completed two EEC portions of study~     Ragweed MATAMPL 204 and who had been treated with either Ragweed MATA MPL or Placebo before~     the 2005 ragweed season will be enrolled.~   "
246600|NCT00325325|"~     The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and~     tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per~     day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be~     performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.~   "
246601|NCT00325312|"~     The purpose of the trial is to evaluate whether patients with acute non specific neck pain~     get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to~     sham ultrasound.~   "
247038|NCT00319475|"~     Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic~     graft to an aorta in AAA and Leriche Syndrome patients~   "
246602|NCT00325299|"~     The primary purpose is to see if magnesium tablet supplementation will decrease elevated GGT~     enzyme activity in alcoholic patients immediately after they had been treated for alcohol~     withdrawal. The secondary aims are to find out whether supplementation decreases the activity~     of ASAT and ALAT enzymes, increases muscle strength, decreases blood pressure and decreases~     depressive symptoms among these patients.~   "
246603|NCT00325286|"~     This is an open label design using Lithium plus extended release carbamazepine (Equetro) in~     combination for 6 months. Rapid cycling bipolar disorder is frequently treatment refractory~     and associated with repeated hospitalizations and complications. The results of this study~     will offer a promising approach to treat this complex disorder. The primary efficacy measure~     will be the time to relapse. Relapse will determined by the investigator based on the~     following: Need for additional pharmacotherapy for mood-related symptoms, hospitalization for~     an mood episode, increase of more than 50% in HAM-D and YMRS scores from the baseline visit.~   "
246604|NCT00325273|"~     The purpose of this study is to determine whether childhood atopic disease decrease or not~     after allowing allergic mothers intake of probiotic (Lactobacillus GG) in second trimester,~     followed by infant intake for 6 months after birth.~   "
246605|NCT00325260|"~     In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is~     already on the market in China. The main objective of the study is to show that both vaccines~     are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac~     will be assessed in the Chinese population.~   "
246606|NCT00325247|"~     Diarrhoea continues to be a major cause of mortality and morbidity in young children~     especially in many developing countries. Although the mortality burden of diarrhoea has~     substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized~     controlled supplementation trials in developing countries have consistently shown that zinc~     has the potential to reduce the duration of diarrhoea as well as has preventive effect on~     childhood diarhroea in subsequent months. Currently, international health agencies recommend~     zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc~     deficiency is highly prevalent and diet is poor in zinc.~      The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode~     of diarrhoea.~      This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs~     10 days) during acute diarrhoea in a rural community in a community-based individually~     randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven~     villages in the ICDDR,B Matlab study area.~      The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly~     allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days).~     Children who will be allocated to the shorter duration therapy will receive placebo for the~     remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct~     diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using~     appropriate statistical procedure.~      Findings of this study will be immensely valuable for deciding recommendation for the~     duration of zinc therapy in the management of acute diarrhoea in young children and will have~     profound programmatic and policy implications for scaling up zinc intervention in the~     community.~   "
246607|NCT00325234|"~     The primary purpose of this study is to help answer the following research questions:~        -  whether the chemotherapy combination therapy Pemetrexed-Carboplatin or~          Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the~          tumor smaller or disappear and for how long~        -  to learn more about the side effects in each chemotherapy combination treatment arm~        -  to assess how participants with advanced breast cancer report health changes while~          receiving any of the chemotherapy combination arm~   "
246608|NCT00325221|"~     Quality of life (QOL) and psychological well-being of patients with implantable~     cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock~     therapies. A close therapeutic relationship between patients and physicians, resulting in~     short reaction times to ICD-treated arrhythmic events and, in an optimised antiarrhythmic~     therapy, may help the patients to deal with their situations in the best possible way.~      The researchers investigate the influence of automatic remote patient monitoring on QOL,~     anxiety, and depression in ICD patients, and kind and frequency of (un-)scheduled~     patient-physician contacts. They also evaluate monitoring-induced changes in patient mobility~     and in patients' perceptions of ICD therapy.~   "
246609|NCT00325208|"~     It is increasingly recognised that rapid growth in infancy may be associated with a greater~     risk of cardiovascular disease later in life. This trial will investigate whether the use of~     infant feeding bottles with different designs influences the milk intake and growth of~     infants. We will compare the growth of bottle-fed infants with that of a breast-fed reference~     group.~   "
246610|NCT00325195|"~     These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene~     glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high~     uric acid levels who are unable to take standard gout therapies, or for whom those therapies~     have been unsuccessful in controlling their uric acid level.~   "
246611|NCT00325182|"~     This study will attempt to examine whether Levetiracetam (Keppra (TM)) can help people with~     alcohol dependence cut down on their alcohol consumption. In addition, the investigation will~     assess the effectiveness of Keppra on reducing withdrawal symptoms post alcohol cessation.~     Matched group of historical controls of alcohol dependent patients receiving placebo will be~     used for comparison.Based on the mechanism of action of Keppra we hypothesize that it may be~     effective in promoting abstinence and reducing drinking behavior in alcohol dependent~     patients.~   "
246612|NCT00325169|"~     This study was designed to evaluate the effects on lung function of a combination of SERETIDE~     50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual~     treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily~     alone) in subjects with COPD. The study will utilise a three-way cross-over design with a~     2-week wash-out period between each 2-week consecutive treatment period.~   "
246613|NCT00325156|"~     To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster~     vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with~     GSK Biologicals' rotavirus vaccine or Placebo.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
246614|NCT00325143|"~     To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib~     vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK~     Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to~     comply with the FDA Amendment Act, Sep 2007.~   "
246615|NCT00325130|"~     Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types~     6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined~     diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in~     adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity~     of the concomitant vaccines.~   "
246616|NCT00325117|"~     This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic~     agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind,~     parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of~     vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes~     inadequately controlled with sulfonylurea monotherapy.~   "
246617|NCT00325104|"~     This study will evaluate the benefits and side effects of a new medication called Cinacalcet~     for treating patients with primary hyperparathyroidism associated with multiple endocrine~     neoplasia type 1 (MEN1) or type 2A (MEN2A). Patients with primary hyperparathyroidism have~     elevated levels of blood calcium caused by too much parathyroid hormone released by one or~     more parathyroid tumors. The parathyroids are small glands located in the neck. Most cases of~     primary hyperparathyroidism are due to a single overactive parathyroid gland, but in MEN1 and~     MEN2A, several glands are overgrown and overactive. Cinacalcet decreases the secretion of~     parathyroid hormone.~      Patients 18 years of age and older with primary hyperparathyroidism and MEN1 or MEN2A and who~     are not candidates for parathyroid surgery may be eligible for this study.~      Participants are admitted to the Clinical Center for 1 week blood and urine tests and imaging~     studies, and initiation of Cinacalcet treatment. They take the drug by mouth and have daily~     blood tests until the dosage required to achieve normal blood calcium levels is determined.~     Patients return to the hospital 2 weeks later for 1 week to evaluate the response to the drug~     and make any necessary adjustments. Treatment may continue for as long as 1 year with 1-week~     admissions every 3 months to monitor the benefits and side effects of Cinacalcet. Evaluations~     may include the following:~        -  Blood and urine analyses.~        -  Measurement of gastric acid secretion. For this test, a soft plastic tube is inserted~          into the nose or mouth and then swallowed and then gently removed about an hour later.~        -  Injections of secretin, calcium and arginine into a vein and collection of blood samples~          to measure the responding increase in levels of gastrin, calcitonin and insulin,~          respectively. These tests are used to diagnose and monitor hormone secretion from~          endocrine tumors and are used in this study to assess the response to Cinacalcet~          treatment.~        -  Radioisotope test to evaluate tumors of the endocrine organs. A radioactive substance~          injected into a vein is taken up by the endocrine tissue and the concentrated~          radioactivity is measured.~        -  Imaging tests, such as MRI and CT, to detect or follow growing tumors in the pituitary,~          neck, and abdomen. CT is a special type of x-ray machine that visualizes tissues, such~          as thyroid or parathyroid tumors. MRI uses a magnetic field and radio waves to obtain~          pictures of different tissues in the head, neck and abdomen.~        -  DEXA scan to assess bone density. This test uses standard low-intensity x-rays.~   "
246618|NCT00325091|"~     This study will examine the effects of long-term practice of repeated finger movements in~     people with focal hand dystonia, as compared with healthy volunteers. Patients with dystonia~     have muscle spasms that cause abnormal postures while trying to perform a movement. In focal~     dystonia, just one part of the body, such as the hand, neck or face, is involved.~      Right-handed healthy volunteers and patients with focal hand dystonia of the right hand 18~     years of age and older may be eligible for this study. Candidates are screened with a medical~     history and neurological and physical examination.~      Participants are trained daily for 11 days (excluding weekends) at the NIH and are asked to~     continue with daily 15 minutes of practice over a 12-week period to perform sequential finger~     movement task (key presses) with their left hand. They practice initially at NIH and then at~     home. At each clinic visit, their learning of the motor skill is assessed by recording their~     performance of 20 consecutive trials of the eight sequences (a total of 160 key presses) in~     the task.~      To evaluate long-term motor learning of the sequential movements, participants are asked to~     do different task tests at Day 2, Week 4 and Week 12. Brain wave activity, and brain~     excitability are also measured during these days. In one task, they see a random series of~     letters on a screen during the sequential finger movements and are asked to say the number of~     times they see a specific letter. In another task, they are asked to focus on each specific~     movement while performing the sequential finger movements. During each visit, they are~     questioned and evaluated for the development of any abnormal movements that may be suggestive~     of early dystonia.~      All participants have an electroencephalogram (EEG) and transcranial magnetic stimulation~     (TMS) at Day 1, and Day 2 and at Week 4 and Week 12 to evaluate brain activity. For the EEG,~     electrodes are placed on the subject's scalp and the electrical activity of the brain is~     recorded while the subject performs the sequence of finger movements. For TMS, a wire coil is~     held on the subject's scalp. A brief electrical current is passed through the coil, creating~     a magnetic pulse that stimulates the brain. The effect of TMS on the muscles is detected with~     small electrodes taped to the skin of the subject's arms or legs.~   "
246619|NCT00325078|"~     This study will determine if the drug infliximab is safe for treating inflammatory bowel~     disease (IBD) in patients with chronic granulomatous disease (CGD). IBD is an inflammation or~     irritation of the gut that leads to symptoms such as diarrhea, bloating and stomach cramps.~     CGD is an inherited disease affecting white blood cells called neutrophils in which patients~     are susceptible to repeated bacterial and fungal infections. They also have a higher~     incidence of some autoimmune diseases, such as IBD. Infliximab is approved to treat Crohn's~     disease, an IBD similar to that seen in patients with CGD.~      Patients 10 years of age and older with CGD and IBD may be eligible for this study.~     Candidates are screened with a medical history, physical examination, blood and urine tests,~     electrocardiogram (EKG), tuberculosis skin test (PPD skin testing), and stool test for the~     presence of infections. Additional tests may be done, including colonoscopy (procedure using~     a flexible tube through the rectum to examine the lining of the gut) and imaging studies such~     as an x-ray, chest CT scan (test using a special x-ray machine), MRI (test using a magnetic~     field and radio waves), and barium studies (study using a drinkable solution of barium to~     help enhance the x-ray pictures of the gut).~      Participants are divided into patients with IBD symptoms (Group 1) and patients without IBD~     symptoms (Group 2) for the following procedures:~      Group 1~      Patients are evaluated every 6 months with a medical history and physical examination for~     signs and symptoms of IBD. Patients who are taking moderate to high doses of steroid~     medications have their medication slowly lowered (tapered) and are evaluated every 3 months~     for a total of 2 years. Patients in this group who start to develop IBD symptoms are moved to~     Group 2 for treatment with infliximab (see below).~      Group 2~      Patients in Group 2 receive infliximab infusions at 2-week intervals for three doses. The~     drug is given over a 2-hour period through a catheter placed in a vein. Patients are~     evaluated with a medical history, physical exam, and blood tests the day of each dose. One~     week after the last dose, they have another evaluation, including a colonoscopy. Patients who~     respond well to infliximab may continue to receive the drug every 2 months for a total of 1~     year, with evaluations at every dosing visit. At the end of the first year of receiving~     infliximab, all patients have follow-up evaluations every 6 months for a total of 2 years.~      Group 3~      Subjects who volunteer to undergo colonoscopy and research biopsies that serve as controls~     for evaluation of the patient gut samples.~   "
246620|NCT00325065|"~     The goal of this protocol, broadly stated, is to use targeted manipulations with intranasally~     administered oxytocin (OT) and arginine vasopressin (AVP) in conjunction with neurocognitive~     and neuroimaging paradigms to evaluate claims that OT and AVP inhibit and facilitate,~     respectively, the effective processing of aversive signals. Moreover, we wish to examine~     whether increased vasopressin levels will increase, and increased oxytocin levels decrease,~     the neural response in the amygdala and other limbic structures to aversive stimuli. In~     addition, we wish to assess whether OT and AVP administration will lead to the facilitation~     of conspecific recognition as appears to be the case for other mammalian species....~   "
246621|NCT00325039|"~     The primary aim of this clinical trial is to compare treatment success for two minimally~     invasive surgical procedures to treat stress urinary incontinence in women. These procedures~     are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes~     for the two surgical procedures, including quality of life, sexual function, satisfaction~     with treatment outcomes, complications, and the need for other treatments(s) after surgery.~     Follow-up will be a minimum of two years.~   "
246622|NCT00325026|"~     The purpose of this study is to compare the time to delivery of two different cervical~     ripening methods on the preterm gestation.~   "
246623|NCT00325013|"~     The researches aim to study the effects of DHA (component of fish oil) on patients with~     Primary Sclerosing Cholangitis (PSC). Our hypothesis is that DHA might reverse the problems~     associated with PSC.~   "
246624|NCT00325000|"~     We examined the hypotheses that severely depressed inpatients treated for 5 weeks with IPT-S~     plus pharmacotherapy have 1) a higher reduction in depressive symptoms and 2) higher~     response- and remission rates compared to pharmacotherapy plus CM. For the follow-up period~     (12 months) we hypothesized a better symptomatic and psychosocial longterm outcome and lower~     rates of relapse for patients initially treated with combination therapy.~   "
246625|NCT00324987|"~     This randomized phase III trial studies imatinib mesylate and bevacizumab to see how well~     they work compared to imatinib mesylate alone in treating patients with gastrointestinal~     stromal tumor that has spread to other parts of the body or cannot be removed by surgery.~     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability~     of tumor cells to grow and spread. It is not yet known whether imatinib mesylate and~     bevacizumab are more effective than imatinib mesylate alone in treating gastrointestinal~     stromal tumor.~   "
246626|NCT00324974|"~     The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules~     oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a~     4-week treatment period.~   "
246627|NCT00324961|"~     This is a phase IV, 2-year, multi-center, single arm and open-label study, evaluating the~     efficacy and safety with using local manufactured adefovir dipivoxil in Chinese subjects with~     HBeAg negative chronic hepatitis B~   "
246628|NCT00324948|"~     Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria~     will be enrolled and randomized to receive either active drug or matching placebo. After a~     two-month, non-treatment period, patients will receive study drug for 6 months and will~     record information about sexual encounters in a daily diary. Study drug will be applied~     directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint~     of the study is based on the use of a standard measure of sexual function (FSEP).~   "
246629|NCT00324922|"~     The primary question of this study is to understand if trimethoprim-sulfamethoxazole~     (TMP-SMX) is as effective as vancomycin for treating methicillin-resistant Staphylococcus~     aureus (MRSA) osteomyelitis.~   "
246630|NCT00324909|"~     Autism is a neurodevelopmental disorder that currently affects as many as 1 out of 166~     children in the United States. Autism is considered by many to be a permanent condition with~     little hope for improvement. Treatment for autism is centered on special schooling and~     behavioral therapy; medical science currently has little to offer.~      Recent research has discovered that some autistic individuals have decreased blood flow to~     the brain, evidence of inflammation in the brain, and increased markers of oxidative stress.~     Multiple independent single photon emission computed tomography (SPECT) and positron emission~     tomography (PET) research studies have revealed hypoperfusion to several areas of the~     autistic brain, most notably the temporal regions and areas specifically related to language~     comprehension and auditory processing. Several studies show that diminished blood flow to~     these areas correlates with many of the clinical features associated with autism including~     repetitive, self-stimulatory and stereotypical behaviors, and impairments in communication,~     sensory perception, and social interaction. Hyperbaric oxygen therapy (HBOT) has been used~     with clinical success in several cerebral hypoperfusion syndromes including cerebral palsy,~     fetal alcohol syndrome, closed head injury, and stroke. HBOT can compensate for decreased~     blood flow by increasing the oxygen content of plasma and body tissues and can even normalize~     oxygen levels in ischemic tissue. In addition, animal studies have shown that HBOT has potent~     anti-inflammatory effects and reduces oxidative stress. Furthermore, recent evidence~     demonstrates that HBOT mobilizes stem cells from human bone marrow which may aid recovery in~     neurodegenerative diseases. Based upon these findings, it is hypothesized that HBOT will~     improve symptoms in autistic individuals.~      The purpose of this study is to determine if HBOT improves clinical outcomes in children with~     autism. The study will also determine if HBOT changes markers of inflammation and oxidative~     stress in autistic children.~   "
246631|NCT00324896|"~     Parkinson's disease (PD) is the second most common neurodegenerative disease in the US,~     affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD~     complain of sleep disturbances, typically sleep fragmentation. Despite the high prevalence of~     sleep problems and their impact on the life of these individuals, there has been, until~     recently, little research focus on the problem. This will be a multi-site, double blind,~     placebo-controlled, two arm, parallel group, fixed-dose trial which will last 6 weeks.~     Seventy patients at four sites (30 at the PI's site and a total of 40 patients at three~     external sites) will be equally randomized to eszopiclone or placebo. The primary hypothesis~     is that eszopiclone will be superior to placebo for the treatment of insomnia in patients~     with Parkinson's disease~   "
246632|NCT00324883|"~     We plan to assess the accuracy of a new means of estimating urine sodium excretion. We will~     compare the chloride to creatinine ratio obtained by titrator sticks with urine sodium~     measured by a standard laboratory. If found to approximate sodium excretion, the titrator~     sticks could provide a convenient means for doctors and patients to monitor their salt~     intake.~   "
246633|NCT00324870|"~     This phase I/II trial is studying the side effects and best dose of vorinostat when given~     together with bevacizumab and to see how well they work in treating patients with~     unresectable or metastatic kidney cancer. Vorinostat may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood~     flow to the tumor. Giving vorinostat together with bevacizumab may kill more tumor cells.~   "
246634|NCT00324857|"~     The purpose of this study is to demonstrate the efficacy of interventions to improve~     understanding of knee replacement risks, benefits, and expected outcomes among AA primary~     care patients, increase willingness to consider knee replacement among AA primary care~     patients, and increase primary care referral rates for surgical consideration for AA patients~     who meet the indications for knee replacement.~   "
246635|NCT00324831|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,~     and prednisone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can~     block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells~     found in bone marrow or peripheral blood and may help the immune system recover from the side~     effects of chemotherapy. Vaccines made from a person's cancer cells may help the body build~     an effective immune response to kill cancer cells. It is not yet known whether giving GM-CSF~     together with vaccine therapy is more effective than giving GM-CSF together with a placebo~     when given after combination chemotherapy and rituximab in treating diffuse large B-cell~     lymphoma.~      PURPOSE: This randomized phase III trial is studying GM-CSF and vaccine therapy to see how~     well they work compared to GM-CSF and placebo when given after combination chemotherapy and~     rituximab as first-line therapy in treating patients with stage II, stage III, or stage IV~     diffuse large B-cell lymphoma.~   "
246637|NCT00324805|"~     This randomized phase III trial studies chemotherapy and bevacizumab to see how well they~     work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage~     IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work~     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as~     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab~     also may stop the growth of non-small cell lung cancer by blocking the growth of new blood~     vessels necessary for tumor growth. It is not yet known whether chemotherapy is more~     effective with or without bevacizumab in treating non-small cell lung cancer.~   "
246638|NCT00324792|"~     The primary objective of the study is to assess the effect of a 3-month intensive insulin~     therapy on urinary leukotriene E4 (LTE4) excretion in patients with diabetes.~   "
246639|NCT00324779|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others~     interfere with the ability of cancer cells to grow and spread. Giving rituximab before~     chemotherapy may be an effective treatment for B-cell non-Hodgkin's lymphoma or B-cell acute~     lymphoblastic leukemia.~      PURPOSE: This phase II trial is studying how well rituximab works in treating young patients~     who are planning to receive chemotherapy for B-cell non-Hodgkin's lymphoma or B-cell acute~     lymphoblastic leukemia.~   "
246640|NCT00324766|"~     The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with~     levosimendan in patients with acute myocardial infarction and heart failure after acute~     percutaneous coronary intervention (PCI) treatment.~   "
246641|NCT00324753|"~     The immediate objective of this proposal is to assess the effectiveness of a multi-faceted~     intervention to improve patient-provider communication about colorectal cancer screening in~     improving patient adherence with colorectal cancer screening recommendations. This~     intervention consists of: (1) guiding the communication process through patient activation to~     initiate a colorectal cancer screening discussion; (2) optimizing communication content~     through the use of a prompt sheet; and (3) cueing the provider to assess patient perception~     of the communication. The long-term objective of our research program is to maximize~     colorectal cancer screening rates throughout the VA through widespread adoption of clinically~     feasible approaches to enhance patient-provider communication.~   "
246642|NCT00324740|"~     This phase I/II trial is studying the side effects and best dose of isotretinoin when given~     together with vorinostat and to see how well they work in treating patients with advanced~     kidney cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Isotretinoin may cause kidney cancer cells to look more like normal~     cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may~     kill more tumor cells.~   "
246643|NCT00324727|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     melphalan directly into the arteries around the tumor may kill more tumor cells. It is not~     yet known whether hepatic arterial infusion with melphalan is more effective than standard~     therapy in treating liver metastases due to melanoma.~      PURPOSE: This randomized phase III trial is studying hepatic arterial infusion with melphalan~     to see how well it works compared to standard therapy in treating patients with unresectable~     liver metastases due to melanoma.~   "
246644|NCT00324714|"~     RATIONALE: Bisphosphonates, such as risedronate, may help improve bone health and prevent~     osteoporosis in postmenopausal women. It is not yet known whether risedronate is effective in~     improving bone mineral density and bone health in women with ductal carcinoma in situ.~      PURPOSE: This randomized phase III trial is studying risedronate to see how well it works~     compared to a placebo in improving bone mineral density and bone health in postmenopausal~     women with ductal carcinoma in situ enrolled in clinical trial CRUK-IBIS-II-DCIS (CRUK:~     Cancer Research UK) (DCIS: Ductal carcinoma in situ).~   "
246645|NCT00324701|"~     The purpose of this study is to see whether therapy for elderly adults with major depression~     can be delivered effectively using videoconferencing technology (telepsychology), which~     allows a therapist and patient who are not in the same room as one another to communicate. We~     are interested in learning if this form of mental health service delivery is an acceptable~     alternative to traditional face-to-face therapy delivered with the therapist in the same room~     as the patient.~   "
246646|NCT00324688|"~     This study looks at HIV-infected subjects who are on methadone treatment and medicines for~     HIV.~   "
246647|NCT00324675|"~     Objective:~      To evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration~     rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due~     to overt diabetic nephropathy.~      Background:~      Diabetic nephropathy is a world wide public health concern of increasing proportions. It has~     become the most common single cause of end-stage renal disease in the United States and in~     Europe. Previous studies have already found agents modifying the renin-angiotensin-system~     (ACE inhibitors and angiotensin receptor blocker) to retard diabetic nephropathy. These~     agents are likely to exert multiple effects in the kidney. One of them appear to be their~     known ability to improve endothelial function and to change renal glomerular hemodynamics.~      In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2~     diabetic patients without end organ damage after treatment with rosiglitazone. In that study,~     rosiglitazone significantly reduced glomerular hyperfiltration. This was associated with a~     reduction of urinary albumin excretion. The observed effects are potentially important in the~     context of renal protection, provided that a similar beneficial effect of rosiglitazone is~     demonstrable in overt diabetic nephropathy (renal insufficiency, hypertension, proteinuria).~      Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in~     patients with chronic renal insufficiency due to overt diabetic nephropathy.~   "
246703|NCT00323921|"~     The appearance of aged skin is a common cosmetic complaint of middle aged and older~     individuals. This study evaluates the safety and efficacy of a new laser with cooling to~     improve the appearance of aged skin. The laser being used will heat various depths of the~     skin while protecting the outer layer.~   "
246648|NCT00324662|"~     A unique single-lead dual-chamber implantable cardioverter-defibrillator (ICD) system~     (produced by Biotronik, Germany) features a conventional electrode in the ventricle (anchored~     in the ventricular apex) and a floating electrode (ring on the lead body) in the atrium,~     capable of sensing atrial electrical signals. The purpose of this study is to determine~     whether this system detects a supraventricular tachyarrhythmia (e.g. atrial fibrillation,~     atrial tachycardia) in the equivalent manner as conventional dual-lead dual-chamber ICDs~     using two separate electrodes anchored in the ventricle and in the atrium, respectively.~   "
246649|NCT00324649|"~     This study evaluated changes in body fat distribution in human immunodeficiency virus type 1~     (HIV-1) infected participants who either switched from a zidovudine- plus lamivudine-~     containing highly active antiretroviral therapy (HAART) regimen to a regimen containing~     Truvada® (a fixed-dose combination tablet of emtricitabine [FTC, 200 mg] and tenofovir~     disoproxil fumarate [TDF, 300 mg]) or who remained on a zidovudine- plus~     lamivudine-containing regimen. Subjects continued their protease inhibitor (PI) or~     nonnucleoside reverse transcriptase inhibitor (NNRTI).~   "
246650|NCT00324623|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, may be used~     to prepare the body for other treatments, such as cellular adoptive immunotherapy. Biological~     therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in~     different ways and stop tumor cells from growing. Vaccines may help the body build an~     effective immune response to kill tumor cells. Giving cyclophosphamide together with~     fludarabine followed by biological therapy may be an effective treatment for metastatic~     melanoma.~      PURPOSE: This phase I trial is studying the side effects of giving cyclophosphamide together~     with fludarabine followed by cellular adoptive immunotherapy, and vaccine therapy in treating~     patients with metastatic melanoma.~   "
246651|NCT00324610|"~     Standard administration of capecitabine use a 14 days administration. Routine practice in~     several intitution leads to use a 5 out of 7 days regimen, with less toxicity.~      Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as~     compared to the standard administration (14 days out of 21). The second end point is to~     compare toxicity with either regimen.~      Method : Randomized study with two groups : one with standard administration , the second~     with 5/7 days regimen~   "
246652|NCT00324597|"~     RATIONALE: AMG 706 may stop the growth of cancer cells by blocking blood flow to the cancer~     or by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such~     as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving AMG 706 together with gemcitabine may~     kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of AMG 706 when given~     together with gemcitabine in treating patients with advanced solid tumors or lymphoma.~   "
246653|NCT00324584|"~     The purpose of this study is to determine if telecare using modern telecommunication devices~     can improve the metabolic control and the quality of life of type 1 diabetic patients.~   "
246654|NCT00324571|"~     This is a randomized, open-label, parallel-design study to be conducted at 75 centers within~     the United States. The study will be described to hemodialysis patients. Informed consent~     will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be~     randomized to receive either Renagel or a calcium-based binder.~      Starting from the randomization date, mortality data including survival, death date and cause~     of death (vital status information) and morbidity data including hospitalization date will be~     recorded for all patients. These data will be collected until the end of the study (December~     31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the~     phosphate binder prescribed by their usual healthcare provider.~   "
246655|NCT00324558|"~     Main objective:~      To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26~     weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases~     progression-free survival.~      Secondary objectives:~      To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26~     weeks, starting with the onset of chemotherapy, increases global survival, improving the~     response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous~     thromboembolism (VTE).~   "
246656|NCT00324545|"~     (1) What effect does behavioral counseling for vegan, for low to moderate fat, and for~     lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different~     diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled,~     maintain their modified behaviors after they have completed their diet program? (4) How does~     targeting different diets affect secondary indices associated with heart disease such as~     weight, lipid, inflammatory, and thrombotic factors?~   "
246657|NCT00324532|"~     The study is an Open Label, Prospective, Non Comparative, Pilot, clinical trial design.~     Patients with inadequate relief in GI symptoms associated with GERD despite PPI treatment~     will be screened and those who meet the inclusion and exclusion criteria will perform a~     glucose breath test for bacterial overgrowth . Each patient will then complete a~     questionnaire to record their GERD related symptoms. Each patient will then receive a daily~     intake of 30 mL two times daily, 30 minutes before meals for a period of 4 weeks. During the~     course of the trial, they will have 4 visits with the study physician to assess treatment~     compliance and occurrence of adverse events, and will complete periodic daily diaries to~     record compliance.~   "
246658|NCT00324519|"~     The purpose of this study is to compare two methods of pregnancy termination on the time to~     delivery in the second trimester.~   "
246659|NCT00324506|"~     The primary objective of this safety/mechanistic study is to determine the safety and~     tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing~     multiple sclerosis. Safety will be assessed by virtue of changes in size and number of~     lesions on MRI scans.~   "
246681|NCT00324207|"~     The objectives of this study are to:~        1. quantitate the level of insulin mRNA in the while cell fraction of whole blood in~          selected groups of subjects,~        2. determine the gene expression of markers of white cell activation in the white cell~          fraction of whole blood in selected subjects,~        3. determine the identity of the white cell responsible for expression of insulin mRNA and~        4. determine protein expression of mRNA of insulin/proinsulin and selected genes of white~          cell activation.~   "
246682|NCT00324194|"~     In this study, MGCD0103, a new anticancer drug under investigation, is given twice weekly to~     patients with leukemia or myelodysplastic syndromes.~   "
246660|NCT00324493|"~     Hemophilia, which results from deficiency of factor VIII or IX, is a common hereditary~     X-linked bleeding disorder affecting up to 10/100,000 population. About 60-70% of them have~     severe disease (factor level <1%). This group is characterized by the occurrence of frequent~     spontaneous bleeding into joints and soft tissues. If inadequately treated, it results in~     progressive damage to joints and muscles leading to crippling deformities. Close clinical~     observation of these patients over many years has shown that those with >1% levels have much~     less bleeding compared to those with less than 1%. This observation has gained immense~     clinical importance in planning therapy for these patients.~      To prevent progressive joint damage, the missing factor needs to be replaced. Much has~     evolved in this practice in the last 50 years. From administration of whole blood in the~     beginning, to plasma and cryoprecipitate, to purified plasma-derived concentrates and finally~     recombinant factor concentrates. The standard of therapy now is to replace factors frequently~     enough to maintain >1% factor levels at all times (“prophylaxis”) or administer immediately~     on premonition or earliest signs of bleeding (“on demand” therapy). This has greatly enhanced~     the quality of life of people with hemophilia. However, the optimal regimens of factor~     replacement remain to be defined. The definition of what is optimal management of this~     chronic condition, currently incurable for the vast majority of patients, varies~     significantly in different parts of the world, depending on practicality and social~     expectations. Models have care have been developed in Western countries based on careful~     documentation of outcome over many years. Such data is lacking from developing countries.~      This multi-center study aims to systematically record the outcome of musculoskeletal function~     in people with hemophilia in developing countries for the first time and provide information~     that can help plan care for the 80% of all hemophiliacs in the world who live in these~     countries. Currently there is no well documented model of care at the range of factor~     replacement practiced in these countries nor is there any significant information on the~     long-term outcome of musculo-skeletal function among these patients.~   "
246661|NCT00324480|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with alvocidib in treating patients with advanced solid tumors. Drugs used in~     chemotherapy, such as vorinostat and alvocidib, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may~     also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving vorinostat together with alvocidib may kill more tumor cells.~   "
246662|NCT00324467|"~     The purpose of this study is to assess whether patients who are likely to fail R-CHOP, as~     predicted by a mid-treatment PET scan, can have an improved outcome if switched to a standard~     salvage regimen R-ICE (rituximab, ifosfamide, carboplatin, etoposide).~      Patients who have a negative PET scan after 4 cycles of R-CHOP have an excellent prognosis~     (>85% chance of cure) and should complete treatment with 6 cycles of standard R-CHOP.~     Patients who have a positive PET scan after 4 cycles of R-CHOP have a very poor prognosis~     (~10% chance of cure) and may have an improved outcome if switched to a non-cross resistant~     chemotherapy combination R-ICE.~   "
246663|NCT00324454|"~     Levetiracetam (Keppra) is used to treat partial onset seizures. Its biological effects~     suggest it might also be useful in treating 3 aspects of human motor neuron diseases (MNDs)~     for which no effective therapy exists: cramps, spasticity, and disease progression.~   "
246664|NCT00324441|"~     The purpose of the study is to evaluate whether mild walter-filtered near infrared~     hyperthermia produces an additional benefit when applied as an adjunct to standard multimodal~     rehabilitation compared to standard multimodal rehabilitation only in patients with~     fibromyalgia.~   "
246665|NCT00324428|"~     This is a phase II study that aims to investigate prospectively a new therapy for a cohort of~     patients with chronic pain attributed to pancreatic cancer. The justification of this study~     is that the pain is the most important factor for the quality of life of these patients and~     rTMS has been shown to be significantly associated with pain improvement in patients with~     abdominal pain due to chronic pancreatitis. This therapeutic trial will be a 10-day,~     randomized, parallel-group design, double-blind, incomplete cross-over, placebo controlled~     clinical trial conducted at Beth Israel Deaconess Medical Center. The principal aim of this~     investigation is the study of pain after a therapeutic intervention. The primary outcome is~     pain reduction indexed by pain reduction and or analgesic intake reduction. The second aim of~     the study is to assess the safety this new treatment in patients with pancreatic cancer. The~     third aim of this study is to investigate whether rTMS treatment is associated with a change~     in the activity of right secondary somatosensory cortex using magnetic resonance~     spectroscopy. Because patients with locally advanced or advanced pancreatic cancer often~     require increasing doses of narcotic pain medications, such as morphine, oxycodone and~     fentanyl, in order to control their pain, adverse side effects are frequent observed in this~     population of patients. Therefore rTMS treatment might represent a new therapeutic approach~     that might be useful not only for pancreatic cancer but also to other types of cancer.~   "
246666|NCT00324415|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and cetuximab together with~     radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and~     cetuximab together with radiation therapy works in treating patients with HIV and stage I,~     stage II, or stage III anal cancer.~   "
246667|NCT00324402|"~     To evaluate the maternal blood concentrations of brain natriuretic peptide (BNP) during the~     second and third trimesters of a normal pregnancy. We will attempt to define a normal range~     for pregnancy and any outliers that may serve as markers for abnormal cardiovascular~     physiology.~   "
246668|NCT00324389|"~     This proposal seeks to use DNA analyses to understand how racial and genetic factors~     influence interferon (treatment) response in HCV infection in African Americans. A better~     understanding should allow rational design of new therapies or better use of existing~     therapies. Patients will provide medical history and undergo a physical exam, blood draws,~     electrocardiogram, possible chest x-ray, and abdominal ultrasound. Patients will be admitted~     to the hospital for 5 days and undergo 2 liver biopsies, sedation, and multiple blood draws.~     Twenty adult male volunteers (10 Caucasians,10 African Americans) ages 18 - 65 years will~     participate.~   "
246699|NCT00323973|"~     Chagas disease (CD) is the major cause of disability secondary to tropical diseases in young~     adults from Latin America. In this region 20 million people are currently infected by T.~     cruzi, the etiologic agent for CD. In Colombia, 18 percent of the population live in CD~     endemic areas, 900,000 people are infected and over three million are at high risk of being~     infected. Heart failure due to Chagas cardiomyopathy (CCM) is the main clinical form of CD in~     Colombia. However, the incidence of CCM among T. cruzi infected people is unknown and the~     mechanisms that lead from infection to CCM are uncertain. Besides the poor prognosis of CHF~     due to Chagas disease, it is important to estimate the risk of complications and death in~     patient infected with T. cruzi Unfortunately, few clinical studies have addressed this issue.~     Most T. cruzi infected patients have mild or no clinical disease, however, the percentage of~     infected people that will develop detectable cardiac abnormalities is approximately 30 to 40~     percent, but only 20 percent of them will develop symptomatic cardiac involvement. Like CHF~     from other causes, CHF due to CD responds to digital, diuretics and vasodilators therapy.~     Also, some studies have shown that angiotensin-converting enzyme (ACE) inhibitors improve~     survival in patients with moderate to severe CHF due to CD. Increased sympathetic drive~     results in an increased risk of cardiac arrhythmia and sudden death. Beta-adrenoreceptor~     antagonism seems to protect against the deleterious effects of chronic sympathetic~     stimulation. The effects of the selective beta-adrenergic receptor blocker Bisoprolol on~     cardiovascular mortality, hospital readmission due to progressive heart failure and~     functional status in patients with CHF secondary to CCM has not been explored to-date. To~     evaluate the benefit of Bisoprolol in CHF due to CCM, a cohort of T. cruzi seropositive~     patients will be selected from several institutions in Colombia. Patients will be classified~     according to a modified version of the Panamerican Health Organization recommendations for~     patients with CCM. Overall one year mortality in patients with CHF due to Chagas disease has~     been reported as 34 percent. However, one year mortality is only 3 percent in patients in~     NYHA functional class II, 27 percent in those in NYHA functional class III, and 62 percent~     among those in functional class IV (22). The sample size has been calculated assuming an~     event rate of 40 percent in two years in the placebo group, and using a 95 percent confidence~     level and power of 80 percent, we will need to recruit 250 patients per treatment arm to~     detect a reduction of 30 percent in the risk of the primary outcome. The event rate we have~     used to estimate sample size is similar to the expected two-year mortality in patients with~     CHF due to Chagas disease in NYHA functional class II. Therefore, the estimated sample size~     should be enough to measure significant changes in the composite primary outcome (death, HF~     hospitalizations, SMVT, SCD). The recruitment process will follow guidelines set out by the~     FCV Ethics Committee. Most participants will be recruited from the Chagas disease and the~     Heart Failure clinics located in Bucaramanga, Bogotá and Cucuta. During the pretreatment~     period an initial evaluation visit will be scheduled in which participants will sign consent~     forms, baseline measurements and tests will be conducted at the FCV including blood pressure~     measurements obtained with patients in the sitting and standing positions. Laboratory test~     such as twelve-lead ECG will be recorded in each patient. Left ventricular ejection fraction~     at rest will be determined by 2D echocardiography, using a modified Simpsons rule to~     calculate LV volumes. Quality of life questionnaire will be performed two weeks apart during~     baseline examination using the Minnesota living with heart failure questionnaire. Minimum of~     two 6-minutes corridor walk test once a week over a two-week period will be performed to~     measure the functional class. During the treatment period patients will be randomly assigned~     to receive double-blind Bisoprolol or placebo, initially taking a total daily dose of 2.5~     mgrs qd. The dose will be increased every two weeks to 5 up to 7.5 and 10 mgrs qd (maximum~     maintenance dose). Follow-up assessment will include clinical check-up, and blood collection~     for future measurements of inflammatory reactants and markers. Quality of life measurements~     will be obtained at six months. Following the descriptive analysis we will compare the~     patient survival and hospitalization rates using Kaplan-Meier estimates and survival graphs.~     Cox regression will be used for the multivariate analysis of time to death and time to~     hospitalization. This analysis will allow us to explore the pattern of changes in patients~     with chronic heart failure due to Chagas disease such as the effect of beta-blockers in this~     special type of cardiomyopathy.~   "
246700|NCT00323960|"~     This is a 5-year project, involving 185 partners from 46 countries (110 in 21 EU States and~     75 in 25 extra-EU States), with a randomised clinical trials (RCT) in juvenile~     dermatomyositis (JDM): 5-year phase III single-blind, RCT in children with newly diagnosed~     JDM: prednisone (PDN) versus PDN plus methotrexate (MTX) versus PDN plus Cyclosporine A. The~     trial is aimed to find out the treatment regimen associated with the lowest occurrence of~     flare and the lowest drug related toxicity~   "
246669|NCT00324376|"~     A randomized, cross-over, open-label study will be conducted to evaluate the equivalency,~     safety and tolerability of sevelamer once per day dosing, given with the largest meal,~     compared with standard three times per day dosing, in hemodialysis patients previously using~     sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to~     one of the following treatment sequences:~        1. sevelamer dosed once a day with the largest meal followed by standard three times per~          day dosing with meals~        2. sevelamer dosed three times per day with meals followed by once a day dosing with the~          largest meal. Patients will maintain a fixed daily dose throughout both treatment~          periods based on the most recently prescribed sevelamer dose prior to screening.~   "
246670|NCT00324363|"~     This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic~     (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.~   "
246671|NCT00324350|"~     The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic~     control for type 2 diabetes (in ACCORD participants) on factors related to bone health,~     including, fractures, falls, and bone mineral density.~   "
246672|NCT00324324|"~     RATIONALE: A donor stem cell transplant can lower the body's immune system, making it~     difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent~     bacterial infections in patients who have recently undergone donor stem cell transplant. It~     is not yet known whether moxifloxacin is more effective than a placebo in preventing~     bacterial infections in patients who have recently undergone donor stem cell transplant.~      PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works~     compared with a placebo in preventing bacterial infections in patients who have recently~     undergone donor stem cell transplant.~   "
246673|NCT00324311|"~     Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is~     known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is~     the source of local and/or systemic infection or sepsis. The local inflammation and infection~     destroy healthy surrounding tissues and extends the original damage. In order to prevent~     these complications, and in order to minimize the risk of infection, it is imperative to~     evaluate the burn and remove all of the offending eschar at the earliest possible~     opportunity. This removal of dead tissue is termed debridement.~      The most direct debridement method for eschar removal is surgery. Traditional, conservative~     non-surgical debridement is a lengthy process which often involves many complications.~      The objective of this study is to evaluate the safety and enzymatic debriding efficacy of~     Debrase Gel Dressing (DGD) in hospitalized patients with deep partial thickness and/or full~     thickness thermal burns and to compare DGD to standard of care (SOC).~   "
246674|NCT00324298|"~     RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. It is not yet known which schedule of bleomycin is more effective when given together~     with etoposide and cisplatin in treating metastatic germ cell cancer of the testicles.~      PURPOSE: This randomized phase III trial is studying two different schedules of bleomycin to~     compare how well they work when given together with etoposide and cisplatin in treating~     patients with metastatic germ cell cancer of the testicles.~   "
246675|NCT00324285|"~     Severe malnutrition is associated with a high rate of mortality, even when using the latest~     WHO recommendations. Watery diarrhea as observed in cholera is an additional vital risk to~     those children. The fragility of the children together with the complexity of the~     pathophysiology and the simplicity of the medical environment where the treatment is~     delivered are serious constraints for the development of new therapies. Dehydration is a~     special immediate risk in those children who already displayed altered body distribution of~     water with potassium, magnesium, zinc and other nutrient deficiency. Dehydration is also~     often associated with a decrease in appetite. In addition, the intestinal function is altered~     both by the infectious agent and the nutritional status of the child. Recommended therapy for~     those children comprises oral rehydration with ReSoMaL (modified ORS for use in severely~     malnourished children recommended by WHO), at a relatively low rate, with permanent~     monitoring; in addition, breastfeeding should not be interrupted and feeding with F100 (Milk~     based formula diet for use in severely malnourished children recommended by WHO) is~     recommended. Recently, amylase-resistant starch added to a standard WHO-ORS has been shown to~     reduce the duration and severity of adults with cholera. The rationale for using~     amylase-resistant starch was that when starch enters the colon it is metabolized by the~     bacteria. The short-chain fatty acids thus produced stimulate sodium absorption in the colon,~     just like glucose stimulates water absorption in the small intestine. In addition, this~     treatment would be of particular interest in malnutrition because short-chain fatty acids are~     specific energetic substrate for the colon.In the present project, we propose to test the~     hypothesis that addition of amylase-resistant starch to the already recommended treatment of~     severely malnourished children with cholera reduces the severity and duration of diarrhea;~     this could be achieved through the effect of short-chain fatty acids on colonic sodium~     absorption. In addition, a better recovery from malnutrition could be achieved through the~     energy provided by short-chain fatty acids to the colon and improved appetite through~     improved rehydration. Thus, the aim of the study is to measure the effect of~     amylase-resistant starch added to an already accepted treatment (with minimal changes) at the~     rehydration and rehabilitation phases of the treatment. A total of 210 children aged 6 mo to~     60 mo will be studied in three groups : a) glucose based ORS and amylase-resistant starch; b)~     glucose based ORS without amylase resistant starch ; c) rice based ORS . The major outcome~     variables on the first phase (diarrhoeal duration and stool output), and second phase (food~     intake, weight gain) will be compared between the two treatment groups. The result of the~     study if found effective in reducing the duration of diarrhoea, enhance recovery from~     diarrhoea and malnutrition in severely malnourished children, will contribute to better case~     management of these children.~   "
246676|NCT00324272|"~     The purpose of this study is to determine whether the use of fibrin sealant reduces~     post-operative drainage following groin and axillary lymph node dissection.~   "
246677|NCT00324259|"~     This study aims to examine whether estradiol is an appropriate for future Phase 3 studies as~     second or third line endocrine treatment. In addition the protocol explores several~     approaches to enhance the safety of estrogen therapy, including the establishment of the~     efficacy of a lower dose than that currently recommended and through the early identification~     of non-responders to avoid drug exposure in patients who are unlikely to benefit to estrogen~     treatment.~   "
246678|NCT00324246|"~     -  In-vitro study~        -  Collect data regarding the color appearance on the new developed indicator strips (NEW~          NORMA-SENSE), in contact with vaginal secretion with elevated pH~        -  Measure the buffering capacity of vaginal secretion from non-symptomatic and symptomatic~          subjects~        -  Detect these indicator strips' performance, in contact with urine~   "
246679|NCT00324233|"~     Intermittent catheterization is a well-known method used for emptying the bladder. The~     objective of this study is to compare the residual urine after intermittent catheterisation~     with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized,~     single blinded, crossover study including 24 healthy males.~   "
246680|NCT00324220|"~     In this study, MGCD0103, a new anticancer drug under investigation, is given three times~     weekly in combination with azacitidine to patients with high-risk myelodysplastic syndromes~     or acute myelogenous leukemia.~   "
246683|NCT00324181|"~     It is suggested the pathogenesis of normal-tension glaucoma (NTG) involves vascular~     dysregulation. In the past studies, it is well documented that many physical problems related~     to vascular dysregulation, such as angina pectoris (Friedman M et al 1974; Russek HI et al~     1976), migraine (Diener HC et al 1994), primary Raynaud's disease (Wagner HH et al 1993) and~     stroke (Gainotti G, et al, 2001; Hayee Ma et al 2001), are associated with a high risk of~     depressive illness. So, NTG, being a disease involving vascular dysregulation, is postulated~     to be associated with psychopathology.~      Glaucoma increases after 40 year-old and the number of people over this age in Hong Kong is~     rapidly growing. However, we have no knowledge about the link between psychopathology and NTG~     in Hong Kong. The present study is sought to overcome the limitation in previous research and~     the goals of present study are:~        -  To identify the prevalence of psychopathology of normal-tension glaucoma Hong Kong~          Chinese Out-patients attending a university-affiliated glaucoma clinic.~        -  To determine whether there are any differences among NTG patients, patients with~          glaucoma other than NTG and control in terms of psychopathology and quality of life.~      Designs:~      Case-control study to compare among patients with normal-tension glaucoma (NTG), patients~     with glaucoma other than normal-tension glaucoma (OTNTG) and control in terms of~     psychopathology and quality of life~   "
246684|NCT00324168|"~     The purpose of this study is to determine whether adding topical steroids improves the~     outcomes of bacterial corneal ulcers, especially visual acuity.~   "
246685|NCT00324155|"~     The purpose of this clinical research study is to examine the safety and effectiveness (how~     well the drug works) of two different treatments for patients with melanoma. One treatment is~     an investigational compound (a drug that is not currently approved by the United States Food~     and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016)~     together with an approved chemotherapy drug called Dacarbazine~   "
246686|NCT00324142|"~     This is a study of the drug tinidazole for women with recurrent bacterial vaginosis. Half of~     the participants will get the drug for 10 days, the other half will get the drug for 10 days~     and then twice a week for 12 weeks.~   "
246687|NCT00324129|"~     In this study, MGCD0103, a new anticancer drug under investigation, is given three times~     weekly to patients with leukemia or myelodysplastic syndromes.~   "
246688|NCT00324116|"~     To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart),~     of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in~     patients with exudative age-related macular degeneration and evidence of recent onset,~     subfoveal and/or juxtafoveal choroidal neovascularization.~   "
246689|NCT00324103|"~     In the last years Structured Treatment Interruptions (STI) have been proposed to reduce~     HAART-related toxicity and to increase patients’ compliance. ISS PART is a randomized~     comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with~     persistent suppression of viral replication. The two arms of the study will be compared in~     terms of immunological response (proportion of patients with CD4>500/mmc) at 2 years.~   "
246690|NCT00324090|"~     The purpose of this study is to investigate the effect of a diet with either high or low~     glycemic index (GI) on ad libitum (free) food intake, body weight, fat mass and fat-free~     mass, risk markers for diabetes and cardiovascular diseases, energy expenditure and substrate~     oxidation after 10 weeks´ intake in slightly overweight subjects.~   "
246691|NCT00324077|"~     The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is~     safe, and whether the combination of the two drugs will help decrease the number of cells~     that contain the Philadelphia chromosome.~   "
246692|NCT00324064|"~     Specific Aim 1 Healthy male and female subjects and growth hormone (GH) deficient subjects~     display sexually dimorphic GH responses to GHRH administration~      Specific Aim 2 GH responses to GHRH in both healthy controls and in GH deficient patients~     correlate with expression and activity of the stimulatory G proteins, G alpha q and G alpha~     S. G protein levels correlate with gonadal steroid levels.~      Specific Aim 3 Sexually dimorphic GH responses to GHRH are enhanced in Tanner Stage V~     compared to Tanner Stage 1 individuals~   "
246693|NCT00324051|"~     The purpose of the study is to estimate drug preference of stable schizophrenic patients who~     will be treated with olanzapine orodispersible tablets for 6 weeks then with olanzapine~     tablets for 6 weeks and vice-versa.~   "
246694|NCT00324038|"~     The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with~     standard- treatment in subjects with osteoarthritis (OA).~   "
246695|NCT00324025|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy~     and safety trial to evaluate Mycograb®. Subjects will be randomized to receive either~     Mycograb® (dosed 1 mg/kg) or placebo during the first week of induction therapy (amphotericin~     B plus 5-flucytosine) via a central line or peripheral venous line twice daily for 7~     consecutive days. The total duration of the study will be approximately 24 months.~   "
246696|NCT00324012|"~     The trial is a phase II trial in adrenocortical carcinoma (ACC), a rare malignancy with poor~     prognosis. It will provide results leading to the establishment of the effect of the included~     drugs. The regimen consists of cisplatin plus taxotere. Over a period of 1-2 years this~     national trial will include 19-36 patients with advanced ACC from different centres in~     Denmark. Patients not responding to the first line treatment will be switched to the~     alternative regimen. The primary objective of this trial is to investigate response rate.~     Secondary endpoints are survival, time to progression, best overall response rate and~     duration of response.~   "
246697|NCT00323999|"~     The aim of the study is to evaluate bipolar equipment versus monopolar, and to see if there~     is any differences between the two types of bipolar equipment espescially regading both~     safety and effect.~   "
246698|NCT00323986|"~     Aims of the study~        -  to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised~          COPD patients~        -  to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa~          colonization and colony counts, and on reduction of the number of~          exacerbations/hospitalisations, antibiotic courses and steroid use.~        -  to evaluate the Quality of Life of patients treated and not treated with azithromycin,~          using a validate Italian version of St George questionnaire~        -  to evaluate the rate of chronic colonization with atypical pathogens~        -  to evaluate the safety and tolerability of a long-term treatment with azithromycin,~          including a survey on possible bacterial antibiotic resistance pattern variations~   "
246704|NCT00323908|"~     A study to examine the correlations between methylation of various genes associated with~     breast cancer and proliferation and cytomorphology in breast epithelial cells acquired by~     random periareolar fine needle aspiration of women at high risk for development of breast~     cancer.~   "
246705|NCT00323895|"~     A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting~     Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.~   "
246706|NCT00323882|"~     Multicenter study in which patients with metastatic hormone refractory prostate cancer~     (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010~     every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at~     escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be~     enrolled in each dosage level. Patients who tolerated and responded to treatment or who had~     stable disease for 3 months or longer and who subsequently progressed during the follow up~     phase of the study had the option to receive additional treatment with MDX-010, up to 4~     cycles. Patients were followed in the study for response up to 2 years and were followed for~     survival status for up to 5 years after enrollment.~   "
246707|NCT00323869|"~     A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as~     treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).~   "
246708|NCT00323856|"~     The purpose of this study is to determine the immunologic and overall safety associated with~     long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less~     than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products~     other than Alphanate and who have no history of developing either antibody inhibitors to~     Factor VIII or nonspecific inhibitors of coagulation.~   "
246709|NCT00323843|"~     Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management~     of kidney stone by topical administration of drugs? In order to secure fewer complications in~     ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human~     to determine its potential of lowering intrarenal pressure.~   "
246710|NCT00323830|"~     The objective of the trial is to compare disease-free survival between adjuvant~     capecitabine/cisplatin alone vs capecitabine/cisplatin with radiotherapy (chemoradiation) in~     curatively resected gastric cancer patients.~   "
246711|NCT00323817|"~     To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia~   "
246712|NCT00323804|"~     Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop~     liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of~     fibrosis is currently under investigation in large multicenter trials. The aim of our study~     is to assess if peginterferon alpha2b plus ribavirin is more efficient than peginterferon~     alpha2b alone. 454 patients will be randomized between the 2 arms and the efficacy will be~     assessed, after 3 years of treatment, on Metavir liver fibrosis score improvement.~   "
246713|NCT00323791|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor~     cells.~      PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see~     how well they work compared with gemcitabine alone in treating patients with metastatic or~     unresectable kidney cancer.~   "
246714|NCT00323778|"~     This study looks at the effect of an injectable medication called Hyalgan on the cartilage of~     the knee in people who have osteoarthritis (wear and tear arthritis) of the knee. Hyalgan~     is a medication which is injected into the knee, and is FDA approved to treat knee arthritis.~     We will be using magnetic resonance imaging (MRI) and x-rays to look at knee cartilage to see~     how it responds over the course of a year to the injections. A comparison to patients taking~     oral pain medication will be made.~   "
246715|NCT00323765|"~     This study will identify changes that occur in the part of the brain that controls hand~     movements in patients with cervical (neck) dystonia. Patients with dystonia have muscle~     spasms that cause abnormal postures while trying to perform a movement. In focal dystonia,~     just one part of the body, such as the hand, neck or face, is involved. The study will~     compare findings in healthy volunteers and patients with cervical dystonia to learn more~     about the condition.~      Healthy volunteers and patients with cervical dystonia 18 years of age and older may be~     eligible to participate. Candidates are screened with a medical history and physical~     examination. Participants undergo the following tests:~      Somatosensory evoked potentials (Visits 1 and 2)~      This test examines how sensory information travels from the nerves to the spinal cord and~     brain. An electrode placed on an arm or leg delivers a small electrical stimulus and~     additional electrodes placed on the scalp, neck and over the collarbone record how the~     impulse from the stimulus travels over the nerve pathways.~      Transcranial Magnetic Stimulation (Visits 2, 3 and 4)~      This procedure maps brain function. A wire coil is held on the scalp. A brief electrical~     current passes through the coil, creating a magnetic pulse that stimulates the brain. The~     stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear~     a click and feel a pulling sensation on the skin under the coil.~      Nerve conduction studies (Visits 2, 3 and 4)~      This test measures how fast nerves conduct electrical impulses and the strength of the~     connection between the nerve and the muscle. Nerves are stimulated through small wire~     electrodes attached to the skin and the response is recorded and analyzed.~      Surface electromyography (Visits 2, 3 and 4)~      Electrodes are placed on the front and back of the neck muscles to measure the electrical~     activity of the muscles.~   "
246716|NCT00323752|"~     The purpose of this study is to establish whether rHuEpo is as effective as PAD in increasing~     red cell mass prior to surgery. Other benefits of the PAD program and preoperative~     administration of rHuEpo will also be compared.~   "
246717|NCT00323739|"~     This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with~     metastatic renal cell carcinoma. In this trial the investigators will evaluate this~     combination in patients previously untreated with any anti-angiogenesis agent and patients~     who have previously received one prior regimen containing an anti-angiogenesis agent.~   "
246718|NCT00323726|"~     Trends in Incidence and Survivals for Ovarian Germ Cell Tumors: A 27-Year Population-Based~     Study~   "
246719|NCT00323713|"~     The purpose of this study is to determine whether the use of a very low protein diet is~     effective in delaying the start of chronic dialysis treatment in patients affected by chronic~     kidney disease (CKD).~   "
246720|NCT00323700|"~     To determine if there is a clinically and statistically significant difference between~     OROS-MPH and IR MPH in ADHA and ODD symptoms by the parent completed SNAP-IV. It is~     hypothesized that OROS-MPH is superior in improving symptom outcomes overall, remission rate,~     functional improvement, quality of life and persistence with medication over time.~   "
246722|NCT00323674|"~     This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a~     minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open~     surgery according to modified Lichtenstein procedure with light weight mesh.~   "
246723|NCT00323661|"~     The purpose of this study is to compare the influence of accelerometer-based rate adaptation~     and Closed Loop Stimulation on cognitive performance and quality of life in pacemaker~     patients.~   "
246724|NCT00323648|"~     Each patient is preoperatively treated once profylactic with intraveneous antibiotics.~     Postoperatively, one group will be treated with intraveneous antibiotics during 5 days. The~     other group will receive no antibiotics.~   "
246725|NCT00323635|"~     This study is being done to compare frequency of urination during the night when women take~     tolterodine tablets vs. when they take placebo tablets.~      We will also measure whether between these two treatment conditions there are any differences~     in women's sleep, mood and performance on cognitive tests.~   "
246726|NCT00323622|"~     The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium~     falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of~     infants and children living in malaria endemic areas. The vaccine would offer protection~     against malaria disease due to the parasite P. falciparum. The vaccine would also provide~     protection against infection with hepatitis B virus (HBV).~      This phase IIb trial is being carried out following the demonstration of efficacy of the~     candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated~     approximately 30% efficacy against clinical episodes of malaria and approximately 58%~     efficacy against severe malaria disease.~      In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the~     safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period~     commencing 21 months after Dose 1.~      This protocol posting deals with objectives & outcome measures of the extension phase at year~     2. During this extension study, no new subjects will be recruited and no vaccine will be~     administered.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
246727|NCT00323609|"~     Patients with osteoporotic vertebral body compression fractures will be randomly assigned to~     treatment with balloon kyphoplasty or vertebroplasty. Over 2 years of follow-up, back pain,~     back function, quality of life, adverse events, subsequent fractures and cumulative~     healthcare costs will be compared.~   "
246728|NCT00323596|"~     Action Seniors!: A 12-Month Randomized Controlled Trial of a Home Based Strength and Balance~     Retraining Program in Reducing Falls Risk Factors~   "
246729|NCT00323583|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and~     5-fluoruracil, work in different ways separately and in combination to stop tumor cells from~     dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes~     side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated~     promising responses in all patients. It is not yet known how effective this drug and dosing~     combination is in treating advanced pancreatic cancer.~      PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel,~     oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in~     treating patient with locally advanced unresectable or metastatic adenocarcinoma of the~     pancreas following demonstrated progression after first-line gemcitabine.~   "
246730|NCT00323570|"~     This trial is conducted in the United States of America (USA). The purpose of this study is~     to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to~     Trauma~      Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.~   "
246731|NCT00323557|"~     The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the~     effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia,~     in patients with chronic lymphocytic leukemia (CLL).~   "
246732|NCT00323544|"~     This study will investigate whether the simplified regimen of a once daily fixed dose~     combination of Truvada (emtricitabine and tenofovir disoproxil fumarate [DF]) will be~     associated with a reduced rate of adverse events, seen with long term use of antiretrovirals,~     as well as improved adherence compared to a twice daily fixed dose combination of Combivir.~   "
246733|NCT00323531|"~     The null hypothesis is that patients receiving either thoracoscopy or fibrinolysis for~     empyema recover in the same amount of time. Therefore, we will test this by randomizing the~     next 40 patients who consent to the study to one treatment or the other.~   "
246734|NCT00323518|"~     CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein,~     is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly~     occurring side effect of high-dose chemotherapy in patients undergoing autologous~     hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the~     safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients~     at risk for developing oral mucositis.~   "
246735|NCT00323505|"~     Multiple myeloma is a rare form of malignancy in which neoplastic plasma cells accumulate in~     the bone marrow. Most malignant plasma cells continue to produce immunoglobulin. The activity~     of multiple myeloma can therefore usually be monitored easily by serial measurement of the~     serum paraprotein levels. Except for a few patients who receive a donor bone marrow~     transplant, multiple myeloma remains incurable despite intensive chemotherapy. Its course is~     typically marked by periods of active disease alternating with increasingly shorter~     remissions.~      Interferons are substances produced in human cells in response to a variety of stimuli, such~     as viral infection. When given to myeloma patients as part of maintenance treatment ,~     interferon-alpha 2 b (INTRONA) has been shown to be of value in prolonging the periods of~     remission. Until now, INTRONA could only be given as injections under the skin, three times~     a week. Some patients experience flu-like symptoms with each injection, particularly early on~     during maintenance therapy. This, as well as the chronic fatigue and even depression that~     INTRONA can induce may considerably reduce the quality of life of myeloma patients on~     interferon, so much so that sometimes this useful adjunct to chemotherapy for myeloma has to~     be stopped.~      Recently, a new preparation of interferon namely pegylated interferon (PEG Intron) has become~     available. It has the advantage of being broken down much more slowly by the body and~     therefore only needs to be given once a week. This minimises the swings in blood interferon~     levels that may be responsible for some of the interferon side effects. The safety and~     superior tolerability of PEG Intron has already been demonstrated in patients with hepatitis~     C for which it now carries a licence, but not in myeloma patients. Here, we propose to study~     whether the quality of life and side effect profile of myeloma patients on PEG Intron is~     better compared to that of Intron®A.~      In the main study, consenting eligible myeloma patients who are well and have been~     established on INTRONA maintenance therapy for at least six weeks will be randomly allocated~     to receive PEG Intron for three months followed by INTRONA for 3 months, or to continue with~     INTRONA for 3 months followed by PEG Intron for 3 months. All patients will be monitored~     regularly for any side effects and will be asked to fill in a quality of life questionnaire~     at the beginning (i.e. before receiving the first randomised treatment) and at the end of~     each study period (i.e. at 3 and 6 months). Initially, we are aiming at enrolling 60 patients~     into this part of the study.~      In a smaller sub-study involving only 14 patients initially, we are proposing to investigate~     whether myeloma patients who need to be taken off Intron®A because of its side effects can~     tolerate PEG Intron more easily. Should their tolerance of PEG Intron also be poor we would~     stop the interferon maintenance therapy altogether. However, should PEG Intron be found to be~     acceptable to them, we intend to switch these patients back to the standard treatment at the~     end of six weeks treatment with PEG Intron to assess whether they have become more tolerant~     of Intron®A in the intervening period. Patients will again be monitored carefully for any~     side effects and will be asked to fill in three quality of life questionnaires (at 0, 6 and~     12 weeks).~   "
246736|NCT00323492|"~     This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected~     patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing~     highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose~     combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg [FTC/TDF]).~     Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease~     inhibitor (PI) at the same dose.~   "
246737|NCT00323479|"~     The purpose of this study is to describe the joint symptoms and structural joint changes~     under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.~   "
246738|NCT00323466|"~     Study to investigate the effect of two types of radiotherapy on saliva: IMRT versus~     conventional radiotherapy.~      In each group, one part will receive normal dental preventive treatment. The other part will~     use products for treatment of dry mouth (Biotene gamma).~      Both anorganic and organic components of the saliva will be studied at different time points,~     combined with bacterial swabs.~   "
246739|NCT00323453|"~     The purpose of this study is to determine whether the incidence of surgical site wound~     infection will be reduced in open appendectomy patients through the use of the Alexis® wound~     retractor.~   "
246740|NCT00323440|"~     Familial Mediterranean fever (FMF) is a genetic disease, caused by mutations in the FMF gene,~     entitled MEFV. The disease is characterized by painful attacks of inflammation in sites lined~     by serous membranes (e.g. abdominal pain caused by inflammation of the peritoneum, a serous~     membrane surrounding all internal organs within the abdomen). Continuous colchicine treatment~     prevents attacks in most patients. The pathogenesis of the disease, what leads to the attacks~     and how colchicine helps, are questions not yet resolved. Elucidating the role of the~     inflammatory proteins is an important step towards the understanding of these questions. To~     date only small numbers of cytokines and inflammatory proteins have been studied~     individually. We propose to study a large number of these proteins in the RNA and protein~     levels addressing the interaction between them and the effect of colchicine on their~     expression.~      Blood samples will be drawn from consenting patients in remission, during attacks, under and~     without colchicine treatment. (20 patients in each category).Twenty healthy volunteers will~     donate control blood samples for the study. RNA will be produced from the neutrophils, and~     cytokines and various proteins' RNA expression will be determined. Major expressed proteins~     will be measured in the same samples and the results will be analyzed with regard to the~     activity of the disease, MEFV mutations and colchicine treatment status. The information~     obtained by the study may allow us to determine the sequence of events associated with FMF~     attack development, and perhaps take us one step further in the understanding of the~     pathogenesis of the disease.~   "
246741|NCT00323427|"~     This study evaluates whether a 2 hour group session, The Living Well with Hearing Loss~     Workshop, can successfully teach hard of hearing people how to best use hearing aids and a~     variety of personal skills to compensate for the limitations of their impaired ears.~   "
246742|NCT00323414|"~     Non-alcoholic steatohepatitis (NASH), the most severe form of liver injury in the spectrum of~     non-alcoholic fatty liver disease (NAFLD), has emerged as the major cause of chronic liver~     disease in developed countries. Among adults in the United States, the prevalence is between~     5.7% and 17%. These rates are expected to increase concurrent with the epidemics of obesity~     and type 2 diabetes mellitus, which are the major risk factors for NAFLD and NASH. In~     addition to its high prevalence, NASH is also a progressive fibrotic disease that advances to~     cirrhosis and liver related death in 20% and 12% of patients, respectively. Among NASH~     patients with cirrhosis, 40% have liver related death. Diabetics are particularly prone to~     experience these poor outcomes. No therapy has been proven effective for patients with NASH.~      The purpose of this study is to find out whether treatment with polyunsaturated fatty acids~     (eicosapentaenoic acid [EPA] combined with docosahexaenoic acid [DHA] called Opti-EPA)~     improves NASH compared to treatment with placebo pills. The placebo pills will contain corn~     oil and will be contained in a capsule, but have no medical effect on the body. The~     investigators will determine improvement in NASH from microscopic changes in the subject's~     liver tissue during 48 weeks of treatment. This means that the subject will need to have a~     liver biopsy before and after the treatment.~      Omega-3 fatty acids are a form of polyunsaturated fats, one of the four basic types of fat~     that the body gets from food. (Cholesterol, saturated fat, and monounsaturated fat are the~     others.) One's body does not make this type of fat; it comes from food sources. These fats~     are found in foods like cold water fish (tuna, salmon, and mackerel), and vegetable products~     like flaxseed oil and walnuts.~      Research shows that polyunsaturated fats are good for people. Studies have shown that it is~     good for heart health by playing a role in keeping blood cholesterol levels low, keeping~     irregular heart rhythms stable, and reducing blood pressure.~      The drug being studied, Opti-EPA, is a nutritional supplement. They do not have to be~     reviewed by the Food and Drug Administration (FDA) like medicines do. Opti-EPA is considered~     experimental in this study. This means that the United States Food and Drug Administration~     (FDA) has not approved it for use in people with nonalcoholic fatty liver disease.~   "
246743|NCT00323401|"~     1. To study the influence of antenatal classes for first time parents and their effect ob~          pregnancy, birth and parenthood.~        2. Randomized into two groups (a. 3 courses in midpregnancy and b. no courses)~        3. Data on pregnancy, birth and parenthood are collected from register and questionaire~   "
246744|NCT00323388|"~     Identification of Risk Allels for Prostate Cancer~   "
246745|NCT00323375|"~     The purpose of this protocol is to perform Phase 1 (safety/toxicity and pharmacokinetic)~     Studies of an investigational aminoquinoline antimalarial (AQ-13) in human subjects. The~     compound to be studied (AQ-13) is being examined because it is active in vitro against~     Plasmodium falciparum malaria parasites resistant to chloroquine (CQ) and other antimalarials~     (multi-resistant P. falciparum), and because its safety was similar to that of CQ in~     preclinical studies performed by SRI International (IND 55,670). AQ-13 was also selected for~     study because it is active in vivo in two monkey models of human malaria: 1] P. cynomolgi in~     the rhesus monkey (Macaca mulatta), a model of human infection with P. vivax, and 2]~     CQ-resistant P. falciparum in the squirrel monkey, a model of human infection with~     CQ-resistant P. falciparum.~   "
246746|NCT00323362|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib~     mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.~   "
246747|NCT00323349|"~     Diabetes mellitus (DM) type 2 is well recognized as a major cause of morbidity and mortality~     in the United States, as well as a significant contributor to health disparities within the~     population. Changes in demographic and lifestyle characteristics in the population have led~     to a progressive increase in the prevalence of both diabetes and impaired glucose tolerance~     (IGT), a precursor to DM type 2. Although pharmacologic interventions have proven to be~     successful in blocking the progression from IGT to DM, they have not been as effective as~     diet and exercise modification. Studies of behavioral interventions in IGT have focused on~     the outcomes of improved DM risk factors and decreased progression to DM, but have either~     required extensive interventions that lack applicability to the general population or have~     utilized more modest interventions with no effect on risk factors. These studies have not~     included impact evaluations to assess the effect of knowledge of IGT status on motivation to~     change and perceived risk. This study will assess the impact of knowledge of IGT on the~     likelihood of altering health-related behaviors, utilizing the Health Belief Model as a~     conceptual framework. Subjects will be randomized to one of four treatment arms, organized in~     a factorial design to (1) assess the impact of OGTT testing on motivation to change behaviors~     and (2) evaluate the efficacy of a novel educational intervention linked to patients'~     learning styles. This evaluation will determine whether OGTT testing is more beneficial as a~     cue to action to motivate behavior change than a multifactorial assessment of diabetes risk.~     Additionally, the improvement in health motivation after an educational intervention is~     expected to be enhanced when the educational method is tailored to the individual's preferred~     learning style. This information will provide the foundation for more efficient behavioral~     interventions for patients at high risk for DM type 2.~   "
246748|NCT00323336|"~     Study is being done to determine if it is possible to use saliva to measure bone specific~     proteins and predict bone turnover which could be used in the treatment of osteoporosis.~   "
246749|NCT00323323|"~     Purpose: This study will evaluate the safety of CHOP plus Alemtuzumab in patients with T/NK~     cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous~     treatments. The biological response of lymphoma cells and the immune system to this drug~     combination will also be measured in patients before, during, and after therapy~     administration.~   "
246752|NCT00323284|"~     The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular~     micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle~     glaucoma or ocular hypertension and co-existing cataract.~   "
246753|NCT00323271|"~     The purpose of this study is to evaluate the efficacy of a brief psychological intervention,~     cognitive-behavior therapy, for the management of persistent pain associated with Multiple~     Sclerosis.~   "
246754|NCT00323258|"~     The purpose of this study is to evaluate the effectiveness of a program to help patients with~     heart disease stay on their heart medications.~   "
246755|NCT00323245|"~     Conservative management for urinary incontinence has been shown to improve bladder control.~     We are conducting a study of the effectiveness of conservative management for urinary~     incontinence in women who also have osteoporosis. We hope to find that treatment for~     incontinence improves bladder control and thereby allows women to be more active and reduces~     their risk of falling and breaking bones.~   "
246756|NCT00323232|"~     Although Standard of Care for Hip Fractures is the Device (Dynamic Hip Screw) being studied~     in this project, and both sizes (the 2 and the 4 hole versions) are currently in use there is~     not widespread agreement yet whether there is an optimal number of screws (2 or 4) required~     for the best outcomes. If it can be shown that a 2 hole version is just as successful in~     outcomes it would allow for a smaller incision (surgical cut) at the site of the fracture.~     This could reduce soft tissue dissection, operating time, and surgical blood loss. This in~     turn would reduce post operative pain, blood loss, and hospital length of stay.~   "
246757|NCT00323219|"~     Patients often come to the emergency department with bacterial skin infections (known as~     cellulitis). Some patients with very severe infections are admitted to hospital for~     antibiotic treatment and some are sent home on oral antibiotics. Many patients have moderate~     infections and are treated as outpatients with daily intravenous antibiotics for 2-5 days. In~     this patient group it is unclear if treatment with oral antibiotics is as effective as~     intravenous antibiotics. The purpose of this study is to determine if treatment of moderate~     cellulitis with an intravenous antibiotic (cefazolin) for 3-5 days is as effective as~     treatment with an oral antibiotic (moxifloxacin). We hypothesize that the oral agent will be~     as effective as intravenous treatment for moderate cellulitis.~   "
246758|NCT00323206|"~     The purpose of this research study is to study a type of gene therapy treatment called~     plasmid electroporation. This type of treatment involves the injection of a gene into some~     melanoma tumors located near the surface of the skin, followed by a burst of electricity into~     the tumor to cause the tumor to take up the gene. This study is a Phase I study to determine~     the side effects and the correct dose of this type of treatment and also its effectiveness in~     treating melanoma. While the electroporation technique has been used in people, the~     combination of plasmid injection and electroporation is being tried in human beings for the~     first time.~   "
246759|NCT00323193|"~     This study involves a controlled trial of an optimized version of a weight management and~     physical activity psycho-educational intervention (called MOVE!) with 200 obese and~     overweight veterans with serious mental illness.~   "
246760|NCT00323180|"~     This study is looking at biomarkers in prostate cancer.~   "
246761|NCT00323167|"~     Mucociliary clearance, in which mucus secretions are cleared from the breathing airways, is~     the primary defense mechanism for the lungs. Inhaled particles, including microbes that can~     cause infections, are normally entrapped in mucus on the airway surfaces and then cleared out~     by the coordinated action of tiny hair-like structures called cilia. Individuals with primary~     ciliary dyskinesia, variant cystic fibrosis, and pseudohypoaldosteronism have defective~     mucociliary clearance. The purpose of this study is to collect clinical and genetic~     information about these three airway diseases to improve current diagnostic procedures.~   "
246762|NCT00323154|"~     Itching is a frequent and disturbing side effect of the use of pain medication such as~     morphine. In the post-operative period, it can be more distressing to pediatric patients than~     their pain. The current first line treatment, an antihistamine (Benadryl), has a low~     efficacy. This treatment causes sleepiness and may be dangerous when used in combination with~     other drugs.~      Nalbuphine has analgesic properties similar to morphine as well as the ability to reverse~     some morphine-induced side effects, such as respiratory depression and itching. Nalbuphine~     has been used effectively for patients undergoing Caesarean sections. However, the~     effectiveness of nalbuphine in the pediatric population has not been investigated.~      We want to determine the efficacy of nalbuphine in the treatment of itching after morphine~     for postoperative pain relief. We will use a novel method to measure the effect of the~     treatment using an intensity scale before and after the drug, to determine the intensity~     difference.~   "
246763|NCT00323141|"~     To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro~     II prothesis in patients with a hernia umbilicalis.~   "
246764|NCT00323128|"~     This study has an open study design. The GFR will be measured using the renal clearance of~     inulin (Inutest) in volunteers with different stage of renal disease or without renal~     disease. A blood sample will be obtained for measuring serum creatinine in different~     laboratories.~   "
246765|NCT00323115|"~     Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be~     treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will~     be administered after three vaccinations for one year or until progression of disease.~   "
246766|NCT00323102|"~     This study aims at a direct comparison between Multihance and a validated comparator like~     Omniscan in a cross-over individual design in patients with brain tumors to confirm the~     superior overall diagnostic performance of MuliHance for this indication~   "
246767|NCT00323089|"~     The objective of this study is to determine if subcentimetre pulmonary nodules can be~     accurately and safely excised by endoscopic stapling devices after they have been localized~     using CT and marked with a microcoil device.~      The addition of real-time CT imaging and insertion of platinum microcoil markers to the~     technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary~     nodules, will decrease the rate of open thoracotomies required to completely resect the~     nodules.~   "
246815|NCT00322452|"~     The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet~     chemotherapy given as first line treatment in terms of progression free survival in selected~     NSCLC patients with the objective of demonstrating non-inferiority.~   "
246768|NCT00323076|"~     Positron Emission Tomography (PET) is a Nuclear Medicine procedure that uses positron~     emitting radiolabeled tracer molecules to visualize biological activity. The presence of~     hypoxia (low oxygen) is associated with poor prognosis in a variety of tumour types and~     treatment strategies targeting hypoxic cells have been developed. The PET tracer [18]F-FAZA~     can identify hypoxic areas, and changes in uptake during treatment may predict tumour~     response.~   "
246769|NCT00323063|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor~     cells.~      PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see~     how well they work compared to gemcitabine alone in treating patients with previously treated~     locally advanced or metastatic breast cancer.~   "
246770|NCT00323050|"~     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a~     booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14~     months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix~     hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.~   "
246771|NCT00323037|"~     The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in~     improving heart function in subjects with stable chronic heart failure.~   "
246772|NCT00323024|"~     The purpose of this study is to determine the safety and maximum tolerated dose of inhaled~     NX1011 for the treatment of pulmonary arterial hypertension (PAH).~   "
246773|NCT00323011|"~     This study is for people with colorectal cancer, who have tumors that cannot be completely~     removed by surgery. Blood clots are a problem in patients with cancer. Blood clots are also a~     problem in patients receiving cancer drugs. Studies have shown that up to 17% of patients~     receiving cancer drugs experienced blood-clotting problems. One purpose of this study is to~     find if the drug combination of irinotecan, 5-fluorouracil (5-FU), bevacizumab and leucovorin~     (LV) affect blood-clotting factors. A second purpose of this study is to find out what~     effects the drug dalteparin has on clotting factors in the blood in patients receiving the~     drug combination of irinotecan, 5-FU, bevacizumab and LV. It is hoped that adding dalteparin~     to chemotherapy may benefit patients with colorectal cancer by preventing blood clots~   "
246774|NCT00322985|"~     T-cell Non-Hodgkin's lymphomas are a group of cancers that are usually treated with~     chemotherapy, radiation therapy, or occasionally surgery. T-cell lymphomas are relatively~     uncommon and therefore not well studied. Treatment approaches are patterned after the more~     common B-cell lymphomas. T-cell lymphomas are more likely to relapse following standard~     therapy than are B-cell lymphomas. New therapies are needed for T-cell lymphomas. In this~     study, we will administer the drug called lenalidomide as a pill to patients with T-cell~     lymphoma. The goals are to determine if the drug can induce regression of the cancer, and to~     determine if the treatment is well tolerated in this patient group. This study will take~     place at six cancer centres across Canada.~   "
246775|NCT00322972|"~     The WHO has initiated a program to eliminate trachoma, blinding eye infection caused by~     Chlamydia trachomatis, in large part by mass distributions of oral azithromycin. The proposed~     study will determine the frequency and treatment target of community-wide mass antibiotic~     treatment. We will also study the impact of mass antibiotic distribution on~     antibiotic-resistance in pneumococcus.~   "
246776|NCT00322959|"~     Tai-Chi-Chuan (TCC), a branch of traditional Chinese martial arts, has been widely practiced~     since the 17th century. Recent studies have shown that TCC can improve cardiorespiratory~     function, muscle strength, humoral and cellular immunity, metabolic response and mental~     control.~      Cultured monocytes from blood or bone marrow can be triggered to differentiate to myeloid~     dendritic cells (DC). DCs are specialized leukocytes for presenting antigens to quiescent,~     naive, and memory T cells, and they play pivotal roles in the induction of cell-mediated as~     well as humoral immune responses in vivo. Mature DCs have a capacity for initiating immunity~     or tolerance, which depends on their activation state.~      In this study we will investigate the effect of TCC on DC differentiation in the peripheral~     blood obtained from the healthy donors who take part with and without TCC exercise. The~     distribution of various DC sub-populations (myeloid DC and plasmacytoid cell) will be~     analyzed by detecting surface marker expression.~   "
246777|NCT00322946|"~     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and~     subtropical regions of the world. The purpose of this study is to evaluate the safety and~     immune response to the dengue vaccine DEN4delta30-4995 in healthy adults.~   "
246778|NCT00322933|"~     This multicentre SHARF4 (Stuivenberg Hospital Acute Renal Failure) study aims to investigate~     outcome in patients with acute renal failure (ARF), stratified according to severity of~     disease (SHARF score) and randomised to different treatment options.~      All adult patients with a serum creatinine >2 mg/dl were included. Patients were stratified~     according to disease severity and those in need for RRT were randomised to intermittent~     (IRRT) or continuous renal replacement therapy (CRRT)~   "
246779|NCT00322920|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of topotecan when~     given weekly with cisplatin in patients with persistent, recurrent, or advanced stage~     cervical cancer. Secondary purposes are to describe the toxicity profile in patients with~     persistent, recurrent, or advanced stage cervical cancer treated with the combination of~     topotecan when given weekly with cisplatin and to determine the response rate and time to~     progression in patients with persistent, recurrent, or advanced stage cervical cancer treated~     with the combination of topotecan when given weekly with cisplatin.~   "
246780|NCT00322907|"~     The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat~     uncomplicated resistant malaria and to compare the outcome with mefloquine or~     quinine+sulfadoxine/pyrimethamine (SP)~   "
246796|NCT00322699|"~     This protocol is evaluating efficacy and toxicity of three sequential whole bladder~     photodynamic treatment with Photofrin and red laser light (630 nm) in the management of~     superficial bladder cancer (non-muscle invasive) in those patients who have failed or are not~     candidates for conventional intravesical therapy.~   "
246797|NCT00322686|"~     The purpose of this study is to determine whether oglemilast is safe and effective in the~     treatment of allergen-induced asthma.~   "
246781|NCT00322894|"~     The Expanded Breast Cancer Registry and Tissue Repository Research Team (EBCR-RT) is~     comprised of University of Mexico Comprehensive Cancer Center faculty and staff whose goals~     are to improve the outcomes and quality of life of patients with breast cancer, and~     ultimately to eradicate and cure breast cancer. One focus of the EBCR-RT is the creation an~     infrastructure that can potentially be adopted as a model for a statewide registry and tissue~     repository for the discovery of biomarkers for this disease.~      The goals of the EBCR are:~        1. To register patients diagnosed with breast cancer and information relevant to their~          diagnosis (such as stage, grade, hormone receptor status, etc), treatment (surgery,~          radiation, chemotherapy, hormone therapy, etc), and survivorship (Quallity of Life,~          etc).~        2. To collect relevant demographics including age, menopausal status, race/ethnicity, body~          mass index (BMI), place of residence, behaviors (smoking, alcohol intake, etc)~        3. To establish a paired tumor tissue and blood sample for each relevant time-point (as~          defined in the protocol), which will be stored in the Tissue Bank Shared Resource~          Facility for future hypothesis-driven research.~   "
246782|NCT00322881|"~     The main purpose of this trial is to look at how elderly women (70 years of age or older)~     with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of~     carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or~     responds to standard carboplatin and paclitaxel chemotherapy.~   "
246783|NCT00322868|"~     Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.~      Primary outcomes: Markers of inflammation (neutrophils, elastase, cytokines and bacteria)will~     be measured in induced sputum specimens before and after a 4 week treatment period with~     pioglitazone in clinically stable CF patients.~   "
246784|NCT00322855|"~     To review the outcome of patients with soft tissue sarcoma treated with chemotherapy from~     2004 and 2005.~   "
246785|NCT00322842|"~     This study evaluates the safety of plerixafor and other outcomes that are purely exploratory~     in nature. One other pre-specified outcome is to evaluate an interval of 10-11 hours between~     dosing with plerixafor and the beginning of apheresis to determine if there will be at least~     a 2-fold increase in circulating CD34+ cells. Data from this protocol will assist in the~     determination of the dosing schedule for future studies.~   "
246786|NCT00322829|"~     The purpose of this clinical study is to develop an easily performed test to detect Group B~     Streptococcus (GBS) in pregnant women at the time of delivery, which would allow health care~     providers to make an accurate and rapid decision regarding the administration of antibiotics.~     Administering antibiotics during delivery reduces significantly the likelihood of~     transmission of GBS, a bacterium that can cause severe life-threatening disease in newborns.~     Three hundred and twenty pregnant females between 18 to 44 years of age, who are admitted for~     delivery at the time of consent, will be recruited at the Centre Hospitalier Universitaire de~     Quebec. Participation involves being observed for 30 minutes. The research nurse will obtain~     2 vaginal/anal samples using standard techniques. One sample will be used to detect GBS with~     the approved BD GeneOhm StrepB assay and the other sample will be used for the development of~     the new point-of-care rapid detection GBS test.~   "
246787|NCT00322816|"~     The purpose of this pilot study is to evaluate the use of (1) 'malaria prevalence', (2)~     'malaria incidence' and (3) 'malaria mortality' as a measure of malaria transmission in The~     Gambia, while mosquito insecticides (larvicides) are used to control malaria-carrying~     mosquitoes. Two thousand children aged 6 months to 10 years of age will be recruited from~     villages in the study area. They will be monitored over 7 months for the presence of malaria~     parasites and signs and symptoms of the disease.~   "
246788|NCT00322803|"~     This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients~     suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35%~     CO2 measured by a visual analogue scale after the first intake and after approximately one~     week of treatment as compared to placebo treatment.~   "
246789|NCT00322790|"~     Differences in 30-year Trends in Incidence and Survival for Malignant Germ Cell Tumors in~     Males and Females.~   "
246790|NCT00322777|"~     Major depression is a widely spread health problem in Canada. Recent research suggests a~     potential role for religion/spirituality in the prevention of and recovery from depression in~     adults. The purpose this study was to assess the efficacy of a home-based Spirituality~     Teaching Program for adults in the treatment of major depression. The objectives of the study~     were to determine:~        1. whether the Spirituality Teaching Program is efficacious in improving depression~          severity, response rate, and remission rate in adults,~        2. whether efficacy is maintained long term (over a 16 week period).~   "
246791|NCT00322764|"~     The primary purpose of this study is to determine the safety and efficacy of oral RG2417~     (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.~   "
246792|NCT00322751|"~     Given the activity of single-agent Topotecan in NSCLC, there is both scientific rationale and~     a medical interest in studying this agent in combination with radiation. In addition,~     Topotecan administered on a weekly basis offers advantages over the daily x 5 regimen, i.e.,~     the convenience of administration and fewer visits to the clinic.~   "
246793|NCT00322738|"~     This study will attempt to find out what effect mosquito insecticides have on the~     transmission of malaria in The Gambia. Eight hundred healthy men and women, aged 18 to 40~     years, living in selected villages east of Farafenni town in The Gambia, West Africa will be~     screened for parasites. About 552 of these people are expected to be free of malaria and will~     form the study group. These people will participate in the study for 7 months and will be~     checked for the malaria-causing parasite every two weeks by finger prick blood sample.~   "
246794|NCT00322725|"~     1.11 Retrospectively evaluate for a correlation between tumor response and changes in~     systolic/diastolic/mean arterial blood pressures in patients treated with bevacizumab, with~     or without chemotherapy, with a wide variety of metastatic malignancies.~      1.12 Retrospectively evaluate for differences in tumor response between patients with and~     without pre-existing hypertension treated with bevacizumab plus or minus chemotherapy with a~     wide variety of metastatic malignancies.~      1.21 Determine if there were differences in bevacizumab induced hypertension rates between~     different tumor types.~      1.22 Evaluate for differences in bevacizumab induced hypertension rates between males and~     females.~      1.23 Examine if there were associations between a particular chemotherapeutic agent(s), that~     may have had an increased propensity of inducing hypertension when combined with bevacizumab.~   "
246798|NCT00322673|"~     This clinical study is being conducted at multiple sites to determine the activity, safety~     and tolerability of XL999 when given weekly to patients with relapsed or newly-diagnosed AML.~     XL999 is a small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR,~     c-Kit, FLT3 and SRC. c-Kit and FLT3 are receptors commonly expressed on AML blasts.~   "
246799|NCT00322660|"~     Children born after elective C-section have a greater risk of respiratory problems and~     hypoglycemia - most likely due to a lower concentration of stress hormones compared to~     children born vaginally. Hypothesis: can we eliminate or reduce the risk of respiratory~     distress and hypoglycaemia by administrating adrenaline to the newborn.~   "
246800|NCT00322647|"~     1. To identify reasons for low patient recruitment numbers to clinical trials in a cancer~          research center setting (and a community setting) in order to attempt to increase~          accrual rates.~        2. To review the screening sheet for women who considered participating in the study of~          Tamoxifen and Raloxifene (STAR) for the prevention of breast cancer in high risk women~          through the University of New Mexico in Albuquerque from 1999 through 2004~   "
246801|NCT00322634|"~     The use of performance status and LDH in combination can predict patient survival more~     accurately than physician clinical impression or the patients' own feelings about their~     survival~   "
246802|NCT00322621|"~     To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from~     Diabetic Neuropathy.~   "
246803|NCT00322608|"~     This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics~     of escalating doses of the vascular disrupting agent NPI-2358 in patients with refractory~     solid tumors or lymphoma. The formation of new blood vessels (angiogenesis) is an important~     component of tumor growth and vascular disrupting agents are intended to target the~     differences between these tumor blood vessels and the blood vessels in normal tissues.~     NPI-2358 has also been seen to directly affect tumor cells.~   "
246804|NCT00322595|"~     The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine~     fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in~     patients with generalized anxiety disorder (GAD).~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
246805|NCT00322582|"~     In many of the patients with cardiomyopathy, the etiology is not clear . In about 30% there~     is a family history of cardiomyopathy .Our aim is to study the genetics basis for these~     patients with cardiomyopathy with no clear etiology and who have a first degree family~     relative with cardiomyopathy as well.~   "
246806|NCT00322569|"~     To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the~     pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm~     and the dual pimecrolimus/paclitaxel-eluting (Symbio) coronary stent compared to the CoStar~     coronary stent control arm for the treatment of single de novo lesions <25 mm in length in~     native coronary arteries 2.5 - 3.5 mm in diameter.~   "
246807|NCT00322556|"~     The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients~     with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety,~     the number of infusions temporally associated with AEs, the rate, severity and relationship~     of all AEs and the vital sign changes during each infusion will be evaluated.~   "
246808|NCT00322543|"~     Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™~     pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo~     lesions of the native coronary arteries.~   "
246809|NCT00322530|"~     The goal of the present study is the comparison of different dialysis strategies in~     critically ill patients with acute renal failure on the intensive care unit. Patients are~     treated with either continuous dialysis or hemofiltration. Outcome measures are death,~     restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.~   "
246810|NCT00322517|"~     To determine the antitumor efficacy and the safety of SU-014813 at a dose of 100 mg orally~     once daily in patients with Metastatic Breast Cancer~   "
246811|NCT00322504|"~     To assess the efficacy of acupuncture treatment in reducing symptoms of anxiety in women~     recently diagnosed with cancer.~      • To assess the efficacy of acupuncture treatment on improving perceived quality of life in~     women recently diagnosed with cancer.~   "
246812|NCT00322491|"~     This study evaluates the safety and efficacy of plerixafor given in addition to~     granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells~     (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and~     multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating~     CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor~     (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN)~     engraftment after transplantation. Data from this protocol will assist in the determination~     of the dosing schedule for future studies.~   "
246813|NCT00322478|"~     Many people with diabetes have a desire to share blood glucose data with other members of~     their team. Using a unique wireless glucose meter device, real-time wireless alerts may be~     automatically sent to a specific team of interested caregivers whom the patient selects.~     Additionally, trending reports can be automatically delivered to any number of authorized~     patient caregivers to facilitate more frequent review of glycemic control.~      This study is recruiting patients from throughout the USA including Hawaii and Alaska.~   "
246814|NCT00322465|"~     This study will look at the safety, effectiveness, and tolerability of combination~     medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation~     of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed~     from person to person during sex. This study will compare the 2 currently recommended NGU~     treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat~     certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin~     may cure NGU better than when doxycycline or azithromycin is used alone. Study participants~     will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in~     Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last~     7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2~     urethral swabs, and have their urethra checked for discharge indicating infection.~   "
246816|NCT00322439|"~     This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for~     5 years.~   "
246817|NCT00322426|"~     The purpose of this study is (1) to determine if patient triggered sensory(auditory, visual~     and tactile) cues can help treat freezing of gait in Parkinson's disease, and (2) to assess~     if unexpected (randomized) cues are more effective than anticipated ones.~   "
246818|NCT00322413|"~     The two epoetins, Epoetin alfa, a well established drug to treat renal anemia and Epoetin~     Omega, that differs from Epoetin alfa in the sugar moiety of the molecule were compared in~     regard of efficacy and safety to treat end stage renal disease anemia. Study hypothesis was~     that Epoetin Omega is non-inferior to Epoetin alfa in correcting renal anemia in dialysis~     patients. A 12-weeks randomized comparative efficacy study was performed including 77 end~     stage renal disease patients (epoetin omega:n=39, epoetin alfa: n=38). In the intent-to-treat~     analysis, average weekly difference in hemoglobin versus baseline value was higher in~     omega-treated patients: 1.94+-0.81 vs. 1.23+-0.62 g/dl. The unadjusted and adjusted~     omega-alfa differences were 0.71 g/dl (95%CI 0.38 to 1.04; p<0.001) and 0.78 g/dl (0.49 to~     1.08;p<0.001), respectively. Average weekly epoetin dose was lower in the omega group: 87+-25~     vs. 108+-21 IU/kg. The unadjusted and adjusted omega-alfa differences were -21IU/kg (-32 to~     -11; p<0.001) and -24IU/kg (-35 to -13; p<0.001), respectively. Epoetins were comparably well~     tolerated. In dialysis patients, subcutaneous epoetin omega apparently provides a greater~     anti-anemic effect per administered dose (IU) than epoetin alfa.~   "
246819|NCT00322400|"~     This open-label, dose-finding, multi-center study is designed to determine the safety and the~     maximum tolerated dose of AMG 706 given once daily in combination with either weekly~     paclitaxel (Arm A) or once-every-3 week docetaxel (Arm B) in subjects with locally recurrent~     or metastatic breast cancer. Secondarily, this study will evaluate the pharmacokinetic (PK)~     profile of AMG 706 in both treatment arms, the PK profile of paclitaxel in Arm A and the PK~     profile of docetaxel in Arm B. Additionally, this study will assess objective tumor response~     and duration of response. Exploratory endpoints include the investigation of potential~     biomarker development and to assess the effects of genetic variation in drug metabolism~     genes, cancer genes and drug target genes on subject response to AMG 706 in combination with~     paclitaxel or docetaxel.~   "
246820|NCT00322387|"~     Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with~     chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to~     determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if~     it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold~     before apheresis, and if transplantation with the apheresis product was successful, as~     measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).~   "
246821|NCT00322374|"~     Tumor response information was obtained for all participants who received at least 2 cycles~     of study drug, underwent requisite baseline and on-treatment disease assessments and had at~     least one post-treatment assessment. Tumor response assessment in evaluable participants was~     done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.~   "
246822|NCT00322361|"~     Hepatitis B Vaccine [Recombinant] is a well-established vaccine which has been used~     extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: [1] induce~     protection against the morbidity and mortality of acute hepatitis B virus infection, [2]~     reduce the incidence of chronic infection in vaccinated populations, and [3] thereby, reduce~     the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new~     manufacturing process of the Hepatitis B Vaccine [Recombinant] vaccine shows the same level~     of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine~     [Recombinant] vaccine. This study will also confirm that the new process vaccine is as well~     tolerated as the current vaccine.~   "
246823|NCT00322348|"~     The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to~     Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced~     breast cancer by assessment of progression-free survival at 24 weeks.~      Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 10.8 mg~     and ZOLADEX 3.6 mg by assessment of adverse events (AEs)and to assess goserelin PK in~     Japanese and Caucasian participants who have received ZOLADEX 10.8 mg by assessment of~     goserelin plasma concentration time profiles~      Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow~     recruitment. 98 (vs the planned 260) patients were randomised into the study and will be~     followed as per protocol for 2 years~   "
246824|NCT00322335|"~     This protocol posting deals with objectives & outcome measures of the extension phase at~     Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary~     phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives~     & outcome measures of the Booster phase/study are presented in a separate protocol posting~     (NCT number =NCT00323050).~      The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib~     antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The~     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
246825|NCT00322322|"~     Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an~     anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac~     dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in~     hemodialysis patients. The patients should be included in the first month after the start of~     chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up~     during one year.~   "
246826|NCT00322309|"~     This research study is being done to look at the safety of the medication Mirtazapine~     (Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage~     will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A~     greater increase in Clinician Global Impression (CGI) score will be observed in the MG than~     in the CG. Secondary Hypotheses: I. A greater decrease in Hamilton Rating Scale for~     Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores will be observed in~     the MG than in the CG. II. A greater decrease in HIV risk behaviors will be observed in the~     MG than in the CG. III. A greater improvement in sleep structure will be observed in the MG~     than in the CG. IV. The proportion of subjects experiencing severe adverse drug reactions~     that necessitate termination from the study by one of the study clinicians will not differ~     between the MG and CG. V. Retention will be greater in MG than in CG.~   "
246827|NCT00322296|"~     Parapsoriasis is a term that refers to a precursor stage of cutaneous T-cell lymphoma~     (CTCL)/mycosis fungoides(MF). Complete responses (clearing) of early presentations of CTCL/MF~     have been shown to be associated with long-term survival and cure. Induction of a complete~     response in parapsoriasis, therefore, would seem to be a desirable therapeutic endpoint.~     Bexarotene 1% gel has been approved for treatment of cutaneous T-cell lymphoma (mycosis~     fungoides). The goal of this study is to evaluate the tolerability, safety and efficacy of~     bexarotene 1% gel in patients with parapsoriasis.~   "
246828|NCT00322283|"~     The purpose of this study is to determine whether it is effective in the treatment of~     exercise-induced asthma and investigate the safety of oglemilast.~   "
246829|NCT00322270|"~     To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events,~     serious adverse events and major bleeding events for up to 120 minutes following the~     instillation of study drug to an occluded central venous access device.~   "
246830|NCT00322257|"~     This trial is conducted in the United States of America (USA) and Canada. The aim of this~     research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary~     safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous~     insulin aspart both in combination with insulin determir in Type 1 Diabetes.~   "
246831|NCT00322244|"~     The study is a randomized, controlled clinical trial that investigates the efficacy ogf~     massage therapy for 66 patients with pain secondary to osteoarthritis of the knee. It is a~     wait-list design where subjects and randomly assigned to either Group A or Group B. Group A~     receives two months of massage while Group B is wait-listed, receives two months of usual~     care. At the conclusion of the wait period, Group B receives two months of massage. In all~     cases, subjects continue to receive conventional medical care for their OA symptoms.~      Outcome measures include a WOMAC questionnaire, a visual analog pain scale, time to walk~     fifty feet and range of motion of the knee (using a goniometer). A research assistant,~     competent in appropriate subject assessment obtains the outcome measures. Change in~     medication use is tracked by the use of patient diaries. Assessments of subjects, occurs at~     baseline, and week 8 and 16 in both the intervention and control groups.~   "
246832|NCT00322231|"~     The purpose of this study is to determine whether the investigational zoster vaccine, is~     generally well tolerated when administered to participants with a history of herpes zoster.~   "
246833|NCT00322218|"~     This study will treat patients with diffuse large B-cell lymphoma whose disease is in~     complete remission due to previous treatment with CHOP-R. Half of the patients will receive~     Zevalin and the other half will receive no further anti-cancer treatment. The two patient~     groups will be compared to determine if Zevalin given after CHOP-R therapy provides greater~     benefits than receiving no additional anti-cancer therapy after CHOP R.~   "
246834|NCT00322205|"~     The overall goal of this research is to increase our understanding of the role of individual~     genetic differences in response to bupropion treatment and the psychobiological mechanisms by~     which genetic and treatment factors interact in the smoking cessation process. The ultimate~     objective is to provide information necessary to match bupropion vs. behavioral counseling~     cessation treatment to those smokers with the greatest need and likelihood of benefit. This~     study is a double-blind randomized placebo-controlled clinical trial of bupropion HCL (brand~     name Zyban) in adult male and female smokers. The factorial design includes one treatment~     factor (bupropion 300 mg/day + counseling vs. placebo + counseling) and several subject~     factors (e.g. genotype, personality). Smoking history, psychological status will be assessed~     at baseline and blood will be drawn for genotyping. Bupropion or placebo will be delivered~     over a 10-week treatment period and subjects will be instructed to quit smoking after two~     weeks of medication (week 3 of treatment). All subjects will also receive a 7-week group~     behavioral smoking cessation treatment (over an 11 week period). This study may yield~     information that will help clinicians identify the most effective smoking cessation treatment~     for a particular patient, based on his/her background.~   "
246835|NCT00322192|"~     The purpose of this study is to test the hypothesis that adding functional strength training~     to UK conventional therapy improves muscle function and walking than either UK conventional~     therapy alone or increased intensity of UK conventional therapy~   "
246836|NCT00322179|"~     The response rate to interferon-based anti-viral therapy for chronic hepatitis C is lower in~     patients who are obese. However, it is not clear whether this is related to suboptimal dosing~     of the medication or alterated response in obese patients. Alterated immune response had been~     reported in obese patients. The goal of current study is to determine the immune response to~     interferon in obese compared to non-obese chronic hepatitis C in an tissue culture system.~   "
246837|NCT00322166|"~     The proposed study will determine the effect of a public health strategy (ie. increased sun~     light exposure and increased calcium intake) to reduce falls in older people in residential~     care using a randomised trial. The primary hypothesis of the trial is that increased~     appropriate sun light exposure will reduce falls, improve 25 hydroxy vitamin D (25OHD) levels~     and lower parathyroid hormone (PTH) levels. Secondary hypotheses are that the intervention~     will reduce accelerated bone turnover, reduce fractures, improve motor function and improve~     mood.~   "
246838|NCT00322153|"~     The objective of this study is to evaluate the safety, tolerability, and efficacy of~     memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of~     the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).~   "
246849|NCT00321997|"~     The purpose of this study is to compare the ability of different doses of pegaptanib sodium~     to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or~     impriving vision in patients with wet AMD when compared to placebo injections.~   "
246850|NCT00321984|"~     The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified~     release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and~     nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal~     reflux disease (GERD).~   "
246851|NCT00321971|"~     This study evaluates the effectiveness of a problem-solving training program in preventing~     depression in the spouses or family caregivers of persons with mild cognitive impairment or~     early dementia.~   "
247108|NCT00318552|"~     This study will directly compare meropenem with standard first line antibiotic therapies in~     subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while~     resident in an ICU.~   "
246839|NCT00322140|"~     Background:~        -  CDDO is a novel synthetic triterpenoid which is a potent multifunctional molecule. It~          induces apoptosis in vitro in malignant cells through both intrinsic and extrinsic~          pathways, and it controls cellular differentiation, apoptosis, and growth inhibition by~          serving as a ligand for the transcription factor peroxisome proliferator activator~          receptor-gamma (PPAR gamma).~        -  Based on in vitro activity, it holds considerable promise as a novel anti-tumor agent~          against a wide range of malignancies by concurrently targeting multiple pathways leading~          to oncogenesis.~        -  In vivo data demonstrates that the drug is well tolerated in dogs, and has anti-tumor~          effects, dependent upon dose schedule.~      Objectives:~      Primary:~        -  To determine the dose limiting toxicities, toxicity profile, and maximum tolerated dose~          of CDDO when administered in adult patients with solid tumors and lymphomas.~        -  To characterize the pharmacokinetics of CDDO.~      Secondary:~        -  To obtain preliminary evidence of anti-tumor activity of CDDO in this population.~        -  To evaluate the in vivo molecular and biological effects of CDDO by assessing changes in~          biomarkers of apoptosis and cell cycle arrest.~      Eligibility:~        -  Patients with advance, histological-confirmed malignancies refractory to standard~          therapy or for which no standard therapy exist.~        -  Patients should have adequate liver, renal and bone marrow function.~      Study Design:~        -  Accordingly with the accelerated titration design 4B, dose levels will initially be~          increased at 100% increments, and one new patient per dose level will be treated per~          4-week course.~        -  The accelerated phase ends when one patient experiences DLT during any course of~          treatment or when two different patients experience grade 2 toxicity during first course~          of treatment.~        -  When the first instance of grade 2 toxicity is observed two additional patients must~          have been treated at that dose, or a higher dose, (during any course) without~          experiencing moderate or worse toxicity, in order that the accelerated phase continue.~        -  When the accelerated phase ends, dose-escalation will revert to a more conservative~          modified Fibonacci scheme with 40% dose-step increments, with at least 3 patients~          treated per dose level.~   "
246840|NCT00322127|"~     This study will determine how safely and well people can tolerate AMD3100 at larger than~     normal doses to mobilize CD34+ cells, (stem cells). AMD3100 is a new drug designed to~     mobilize stem cells for transplantation in cancer patients. It pushes those cells into the~     circulation, making it easier to collect them, and it temporarily increases the number of~     stem cells in a person's blood.~      Patients ages 18 to 50 in good health and who are not pregnant or breastfeeding may be~     eligible for this study. They will undergo the following tests and procedures:~        -  History and physical examination~        -  Review of medications, including those prescribed and over-the-counter, as well as~          nutritional supplements~        -  Blood tests for liver, kidneys, and other functions; and for infections including~          hepatitis and AIDS~        -  Pregnancy test~        -  Electrocardiogram~      On the day they receive AMD3100, patients will be admitted to the Clinical Center. They will~     receive two doses, injected under the skin, at intervals separated by 14 to 90 days. Dose~     levels are 240 and 320 micrograms/kg and 400 and 480 micrograms/kg. For 24 hours following~     the first AMD3100 administration, blood will be collected periodically through a plastic tube~     at amounts dependent on doses of AMD3100 given. If patients receive one of the two highest~     doses, their heart rhythm will be monitored continuously during the hospital stay. From 7 to~     10 days following administration of AMD3100, patients will give blood samples to monitor the~     effects. The second dose of AMD3100 will be given 14 to 90 days after the first one. Patients~     will return to the Clinical Center for the same procedures as done previously, but the dose~     of the drug will be higher.~      Risks involve side effects of AMD3100. In previous studies, patients who received the drug~     experienced a temporary increase in white blood cell counts. Serious side effects have~     included abnormally low platelet clot, abnormal heart rhythm, and low blood pressure.~     Patients will be carefully monitored for such effects.~   "
246841|NCT00322114|"~     RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from~     forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may~     keep prostate cancer from forming.~      PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing~     prostate cancer in healthy participants.~   "
246842|NCT00322101|"~     RATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and~     cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell~     transplant helps stop the growth of cancer cells. It may also stop the patient's immune~     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are~     infused into the patient they may help the patient's bone marrow make stem cells, red blood~     cells, white blood cells, and platelets. It is not yet known whether low-dose chemotherapy~     and total-body radiation therapy is more effective than high-dose chemotherapy in treating~     patients with myelodysplastic syndrome or acute myeloid leukemia.~      PURPOSE: This phase III trial is studying low-dose conditioning to see how well it works~     compared to high-dose conditioning followed by peripheral blood stem cell transplant in~     treating patients with myelodysplastic syndromes or acute myeloid leukemia~   "
246843|NCT00322075|"~     Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic~     patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of~     HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal~     and prandial insulin, satisfaction with treatment, incidence of adverse events.~   "
246844|NCT00322062|"~     The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium~     phosphate solution already on the market. Efficacy of each bowel preparation, safety and~     acceptability will be assessed.~   "
246845|NCT00322049|"~     The main target populations for the tetravalent live attenuated dengue virus vaccine are~     indigenous populations, especially infants less than 2 years old, residing in areas of the~     world endemic for dengue and at risk of developing dengue hemorrhagic fever (DHF). The~     presence of maternal dengue antibody during the first year of life makes it unlikely that a~     vaccine given during that time will have long-term efficacy, as the vaccine virus would~     likely be neutralized prior to necessary replication. Children older than 18 months may have~     preexisting flavivirus antibody. Therefore, vaccination of infants living in Thailand early~     in the second year of life (between the ages of 12 and 18 months) seems most beneficial. The~     aim of this trial is to evaluate the safety and immunogenicity of a two-dose schedule of a~     tetravalent live attenuated dengue vaccine in flavivirus antibody naïve infants beginning at~     12-15 months of age.~        -  To assess the kinetics of dengue neutralizing antibodies to each dengue virus serotype~          one and four years following dose 2 of dengue/control vaccination in the setting of~          potential wild-type dengue virus exposure.~        -  To assess the immunogenicity, the safety and reactogenicity of a booster dose of dengue~          vaccine administered at Year 3 following primary vaccination.~   "
246846|NCT00322036|"~     This is a multinational, randomized, double blind, placebo controlled, parallel group study~     comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo.~     Study subjects will have the diagnosis of mild dementia of the Alzheimer's type. Subjects may~     be taking approved medication for Alzheimer's disease provided the dose has been stable for~     at least 6 months.~   "
246847|NCT00322023|"~     This study will determine whether increasing D-serine within the body will improve negative~     symptoms and cognitive impairments in people with schizophrenia.~   "
246848|NCT00322010|"~     To study all ICU patients with an independent baseline functional status, who experience a~     critical illness requiring intubation and mechanical ventilation, evaluating the role of~     protocol-directed, early physical and occupational therapy on the incidence of critical~     illness associated functional debilitation. Our goal is to hasten the recovery of independent~     physical functioning as well as to reduce ICU delirium in the group of patients who begin~     this intervention from the earliest hours of ventilator dependence.~   "
246852|NCT00321958|"~     The purpose of this study is to confirm the effectiveness and safety of a new medical device~     which sprays liquid nitrogen through an upper endoscope (cryotherapy) to treat Barrett's~     esophagus with high-grade dysplasia and early esophageal cancer. It is hypothesized that this~     treatment will remove the abnormal lining of the esophagus and allow the normal esophageal~     lining to return.~   "
246853|NCT00321945|"~     It is well known that atrial fibrillation (AF) and atrial flutter occur frequently after most~     types of cardiac surgeries.(1-4) Postoperative AF is associated with significant morbidity,~     longer hospital stay, and higher related costs. Currently, it is common procedure to~     premedicate patients with antiarrhythmic drugs for elective cardiac surgeries. Treatments~     such as beta blockers, Amiodarone, and electrical pacing are used to help prevent the~     morbidity associated with pot-operative AF.(5)~      Renin-angiotensin system (RAS) activation may contribute to AF. Several clinical trials have~     suggested that inhibitors of this system may reduce the incidence of AF.(6-12) Patients with~     AF are known to have increased levels of angiotensin converting enzyme (ACE) and some types~     of angiotensin receptors.(13-15) Data from animal studies performed by our group suggest that~     cardiac ACE overexpression may lead to arrhythmic ion channel changes.(16;17) Although not~     studied in this group yet, it would be reasonable to conclude that the use of ACE inhibitors~     and angiotensin receptor blockers (ARBs) would decrease the incidence of AF in post-operative~     patients, too~   "
246854|NCT00321932|"~     RATIONALE: Zoledronic acid, vitamin D, and calcium may prevent bone loss in patients who are~     undergoing donor stem cell transplant.~      PURPOSE: This randomized phase II trial is studying how well zoledronic acid works in~     preventing osteoporosis in patients undergoing donor stem cell transplant.~   "
246855|NCT00321919|"~     This study will evaluate whether anemia prevention with NeoRecormon has an additional impact~     on reducing cardiovascular risk over conventional anemia treatment in patients mostly with~     stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is~     2+ years and the target sample size is 500+ individuals.~   "
246856|NCT00321906|"~     The purpose of this study is to compare the safety and effectiveness of two different~     anti-rejection drug regimens.~   "
246857|NCT00321893|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of budesonide may keep lung cancer from forming in patients with lung~     nodules.~      PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in~     treating patients with lung nodules who are at high risk of lung cancer.~   "
246858|NCT00321880|"~     RATIONALE: Supportive care, such as healing touch, may improve quality of life in patients~     receiving chemotherapy for acute leukemia.~      PURPOSE: This clinical trial is studying how well healing touch works in treating patients~     receiving chemotherapy for acute myeloid leukemia or acute lymphocytic leukemia.~   "
246859|NCT00321867|"~     The purpose of this study is to determine whether adding a graft during a rectocele repair~     will improve the success rate of the repair.~   "
246860|NCT00321854|"~     This is a double blind, placebo-controlled clinical trial of 15 months duration designed to~     examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in~     patients with new onset Parkinsons disease~   "
246861|NCT00321828|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab~     may also stop the growth of colon cancer by blocking blood flow to the tumor. Giving~     combination chemotherapy together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed~     by surgery.~   "
246862|NCT00321815|"~     To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in~     patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one~     prior chemotherapy regimen.~   "
246863|NCT00321802|"~     The purpose of this study is to determine the effect of statin therapy for prevention of~     atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial~     fibrillation in the absence of significant coronary artery disease.~   "
246864|NCT00321789|"~     We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient~     treatment adherence. A randomized controlled trial compared a one-year, telephone-based~     patient-spouse intervention to usual care. The primary outcome was LDL-C measured three times~     (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and~     exercise, also assessed at baseline, 6 months, and 11 months.~   "
246865|NCT00321763|"~     The purpose of this phase IIb study is to demonstrate the consistency of three lots of an~     adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to~     Fluarix™ administered intramuscularly in elderly aged 60 years old and above.~   "
246866|NCT00321750|"~     Background and hypothesis. Oral erosive lichen planus (OELP) is a severe form of mucosal~     lichen planus. Lesions often induce intense pain and limit feeding. Its course is chronic~     with flares and spontaneous remissions are rare. Treatment is difficult: topical steroids are~     usually used first but antimalarials, oral retinoids, systemic steroids, immunosuppressive~     drugs and even extracorporeal photochemotherapy can be necessary for treating severe forms.~     The need for novel therapies with less morbidity is obvious. Calcineurin inhibitors have a~     theoretical interest in treating OELP: this has been emphasized by several open studies~     performed with topical tacrolimus. The effectiveness of 1% pimecrolimus cream has been~     suggested by a few case reports and by one recent comparative study which confirmed the~     potential interest of topical pimecrolimus in treating OELP. The absorption of pimecrolimus~     through human mucosa is still unknown. Its application on ulcerative lesions such as OELP~     ones, could lead to significant systemic levels of the molecule.~      Objective: To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen~     planus (OELP) and to assess its tolerance.~   "
246867|NCT00321737|"~     The purpose of this study is to assess the ability of once-daily (QD) treatment with~     dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of~     erosive esophagitis (EE).~   "
246868|NCT00321724|"~     This phase II trial is studying how well AZD2171 works in treating patients with relapsed or~     refractory B-cell chronic lymphocytic leukemia. AZD2171 may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the~     cancer cells~   "
246869|NCT00321711|"~     The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence~     of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet~     transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS)~     receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the~     appropriate dose and schedule, will result in reduction in the incidence of clinically~     significant thrombocytopenic events in low or intermediate risk MDS subjects receiving~     hypomethylating agents.~   "
246870|NCT00321698|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving radiation therapy~     together with chemotherapy before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when~     given together with radiation therapy and to see how well they work in treating patients who~     are undergoing surgery for high-risk localized prostate cancer.~   "
246871|NCT00321685|"~     This phase II trial studies how well giving bevacizumab, radiation therapy, and combination~     chemotherapy works in treating patients who are undergoing surgery for locally advanced~     nonmetastatic rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some find tumor cells and kill them or carry tumor-killing~     substances to them. Others interfere with the ability of tumor cells to grow and spread.~     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine,~     may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as~     capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     bevacizumab together with radiation therapy and combination chemotherapy before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~     Giving bevacizumab together with combination chemotherapy after surgery may kill any tumor~     cells that remain after surgery.~   "
246872|NCT00321672|"~     The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or~     60 minutes for the treatment of painful HIV-associated neuropathy.~   "
246873|NCT00321659|"~     The overall objective of this work is to improve treatment outcomes for persons with~     fibromyalgia by optimizing the approach to self-management. The purpose of this research~     project is to evaluate and compare, in a randomized, controlled trial involving 200 women,~     the short and long-term effectiveness of four approaches to fibromyalgia self-management for~     improving health and functional status, self-efficacy, and symptom severity. Additionally, we~     will also examine the effect of each intervention on health care usage. We will assess the~     following 16-week interventions:~        -  cardiovascular and flexibility exercise~        -  strength training, cardiovascular and flexibility exercise~        -  Arthritis Foundation's Fibromyalgia Self-Help course~        -  a combination of the Fibromyalgia Self-Help Course and strength training exercise~          interventions~   "
246874|NCT00321646|"~     The main purpose of this trial is to collect information and to evaluate the effects, good or~     bad, the combination of docetaxel and bevacizumab has on patients with high risk prostate~     cancer that are undergoing radical prostatectomy.~   "
246875|NCT00321633|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. It is not yet known whether carboplatin is more effective than docetaxel in~     treating patients with metastatic genetic breast cancer.~      PURPOSE: This randomized phase II trial is studying carboplatin to see how well it works~     compared to docetaxel in treating women with metastatic genetic breast cancer.~   "
246876|NCT00321620|"~     The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid~     (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer~   "
246877|NCT00321594|"~     This phase I/II trial is studying the side effects and best dose of belinostat and to see how~     well it works in treating patients with liver cancer that cannot be removed by surgery.~     Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth~   "
246878|NCT00321581|"~     Background:~        -  AZD2171 is an experimental drug that may slow the growth of cancers by blocking~          angiogenesis (formation of new blood vessels).~        -  Cancer growth is dependent on angiogenesis for nutrition.~        -  Inhibiting angiogenesis is a new approach to cancer therapy.~      Objectives:~        -  To determine the side effects of AZD2171 in children and adolescents with cancer.~        -  To determine the highest dose of AZD2171 that can safely be given to children and~          adolescents with cancer.~        -  To study how the body handles AZD2171.~        -  To determine the effects of AZD2171 on various factors related to angiogenesis.~        -  To determine if AZD2171 can inhibit cancer growth in children and adolescents.~      Eligibility:~      -Children and adolescents 2-18 years of age with treatment-resistant solid tumor cancers or~     acute myelogenous leukemia.~      Design:~        -  About 40 patients may be included in the study.~        -  AZD2171 is given by mouth in treatment cycles of once a day for 28 days. Treatment may~          continue unless the cancer worsens or unacceptable side effects develop.~        -  Patients have periodic physical examinations, blood and urine tests and imaging tests~          (CT, X-rays, MRI) to evaluate disease throughout the course of treatment. Additional~          blood tests are done to study how the body handles AZD2171, to look for proteins that~          stimulate angiogenesis, to determine if certain blood vessel cells are affected by~          AZD2171, and for other research purposes.~        -  Biopsy tissue (when available) is examined for the receptor for new blood vessel~          formation.~   "
246957|NCT00320528|"~     This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and~     emotional well being of children and adolescents with ADHD and to evaluate whether and in~     what measure the presence of comorbid conditions (internalizing and externalizing disorders)~     influences atomoxetine's ability to improve the quality of life of ADHD subjects.~   "
246879|NCT00321568|"~     This study will evaluate the ability of magnetic resonance imaging (MRI) using different~     magnet strengths (1.5, 3 and 7 Tesla) to detect damage in different parts of the brain in~     patients with multiple sclerosis. The higher the Tesla, the greater the ability to see brain~     changes. Healthy subjects will also be studied to compare findings in patients with those of~     normal volunteers.~      Healthy normal volunteers and patients with multiple sclerosis 18-65 years of age may be~     eligible for this study. Patients should have minimal clinical disability. Candidates are~     screened with a medical history, physical examination, and blood and urine tests.~      Participants undergo three MRI examinations. The first is on a 1.5 Tesla machine. The second~     and third - at 3 Tesla and 7 Tesla - are done within 30 days of the first. Each procedure~     takes about 2 hours. Before and after the 7 Tesla examination, subjects have an~     electrocardiogram (EKG), their blood pressure and temperature are measured and a blood sample~     is drawn.~      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. This~     test has several advantages over x-ray methods, such as the ability to see more clearly~     inside the brain and to see chemical changes that might occur in specific neurological~     diseases. Also, since x-rays are not used, there is no radiation risk. Radio waves are~     generated and changes in magnetic fields are measured and analyzed by computer. For the~     procedure, the subject lies on a table that is moved into a metal cylinder (the MRI scanner)~     that has a strong magnetic field. Earplugs are worn to muffle loud thumping noises caused by~     the electrical switching of the radio frequency circuits. During the MRI, subjects receive an~     injection of a contrast agent called Gadolinium, which brightens the images.~   "
246880|NCT00321555|"~     Background:~        -  About 80% of patients with hairy cell leukemia (HCL) have tumor cells that have a~          protein on their surface called CD25.~        -  The experimental drug LMB-2 is a recombinant immunotoxin that has been shown to kill~          leukemia and lymphoma cells with the CD25 protein. (A recombinant immunotoxin is a~          genetically engineered drug that has two parts - a protein that binds or targets a~          cancer cell, and a toxin that kills the cancer cell to which it binds.)~      Objectives:~        -  To evaluate the safety and effectiveness of LMB-2 in patients with HCL whose cancer~          cells contain the CD25 protein.~        -  To evaluate the effects of LMB-2 on the immune system, determine how the drug is~          metabolized by the body and examine its side effects.~      Eligibility:~      -Adults with hairy cell leukemia whose tumor cells have CD25 on their surface~      Design:~        -  Up to 27 patients may be included in the study.~        -  Patients receive an infusion of LMB-2 through a vein every other day for three doses~          (days 1, 3, 5), constituting one treatment cycle.~        -  Patients may receive up to six treatment cycles every 4 weeks unless their cancer~          worsens or they develop unacceptable side effects.~        -  Blood is drawn weekly for various tests.~        -  Before each cycle and in follow-up visits, disease status is evaluated with a physical~          examination, blood tests, chest x-ray and electrocardiogram.~        -  Before the first cycle, patients may have a CT scan, echocardiogram (heart ultrasound~          test) and bone marrow biopsy. With the patient's permission, these tests may be repeated~          before other cycles also.~   "
246881|NCT00321542|"~     The study aims to examine if non-invasive imaging of the coronary arteries by CT angiography~     using an intra-venous injection of X-ray contrast medium in asymptomatic patients with adult~     onset diabetes mellitus can predict the risk of developing coronary heart disease.~   "
246882|NCT00321529|"~     The purpose of this study is to determine if the ProAdjuster system of analysis can be used~     to determine cervical spine instability using the Penning system of radiographic marking as a~     standard of comparison.~   "
246883|NCT00321516|"~     The purpose of this clinical research study is to learn if aripiprazole has a drug-drug~     interaction with lamotrigine.~   "
246884|NCT00321503|"~     This study is a test of how well a new FDA-approved device is for diagnosing a condition~     known as laryngopharyngeal reflux (LPR). The device, which measures pH of the air in the~     upper throat, will be compared to several other methods for diagnosing laryngopharyngeal~     reflux.~   "
246885|NCT00321490|"~     This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and~     safe in the treatment of patients with MDD.~   "
246886|NCT00321477|"~     This is a Phase IIa study to evaluate the efficacy, safety and tolerability of GW679769 vs~     placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with~     overactive bladder in women.~   "
246887|NCT00321464|"~     The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in~     the treatment of bone metastases in subjects with advanced breast cancer.~   "
246888|NCT00321451|"~     Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain,~     fatigue, and multiple tender points. The majority of individuals with FM report sleep~     problems, including delayed sleep onset, extended awakenings, and non-restorative sleep.~     These sleep disturbances may worsen FM-related pain, fatigue, low mood, and low energy. The~     purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia~     therapy in reducing sleep disturbances and improving other FM-related symptoms.~   "
246889|NCT00321438|"~     The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or~     non-phenotypeable virus while receiving standard of care therapy. This is an observational~     study. No investigational treatment will be administered through this study.~   "
246890|NCT00321425|"~     In an observer-blinded study ultrasound guidance and electrical nerve stimulation will be~     compared for lateral sagital infraclavicular blocks (LSIB). Block effectiveness, time~     consumption and patient acceptance will be registered in 80 patients. Ultrasound guidance may~     cause less discomfort and could be less time consuming than electrical nerve stimulation.~   "
246891|NCT00321412|"~     The objective of this study is to evaluate the safety and effectiveness of the experimental~     drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have~     fistulas. The study will test whether or not patients receiving AST-120 experience a greater~     reduction in number of draining fistulas and improvement of their other Crohn's disease~     symptoms versus patients who receive placebo (material that does not contain any active~     medication).~   "
246990|NCT00320099|"~     This study will compare, in adults with septic shock, the safety and efficacy of a~     combination of moderate doses of corticosteroids and intensive insulin therapy to that of~     moderate doses of corticosteroids. In addition, this study will compare the efficacy and~     safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone~   "
246892|NCT00321399|"~     Three main clinical outcomes will be assessed:~        1. Post-test resource utilization as assessed by referral rate to catheterization within~          90-days of the index study;~        2. Incremental prognostic value and risk stratification for predicting cardiac death and~          myocardial infarction;~        3. Cost-effectiveness~      To this end, SPARC is organized with two distinct specific objectives with important~     differences in patient population and endpoints.~      Specific Aim 1: To evaluate the impact of stress perfusion imaging with SPECT or PET, CT~     Angiography, and hybrid PET-CT on post-test resource utilization.~      The primary endpoint of specific aim 1 is to compare the impact of combined myocardial~     perfusion-coronary anatomy data to that of perfusion only [stress SPECT, stress cardiac PET~     (without CTA)] and anatomy only (CTA alone) on post-test resource utilization, as measured by~     referral to cardiac catheterization within 90 days of index noninvasive testing, in patients~     without CAD.~      Secondary endpoints:~        1. to compare the diagnostic accuracy for detection of epicardial CAD of stress PET and~          hybrid PET-CT, stress SPECT, and CTA, as defined by coronary angiography;~        2. to compare the referral rate to revascularization within 90 days of cardiac~          catheterization.~      Specific Aim 2: To compare the incremental prognostic value and risk stratification of stress~     perfusion imaging with SPECT or PET, CT coronary angiography, and combined perfusion-anatomy~     imaging approaches.~      The primary endpoint of specific aim 2 is to compare the incremental value of stress~     perfusion only (stress PET and stress SPECT), coronary anatomy only (CTA data), and combined~     perfusion-anatomy studies (PET+CTA and SPECT+CTA) over clinical, historical and stress test~     data for the prediction of cardiac death and nonfatal myocardial infarction.~      Secondary endpoints:~        1. to compare the incremental value of these noninvasive imaging approaches over clinical,~          historical and stress test data for the prediction of a composite endpoint including~          cardiac death, nonfatal myocardial infarction, late (>6 month from index study) referral~          to revascularization, or late (>6 month from index study) hospitalization for chest pain~          or heart failure;~        2. to compare the incremental value of these noninvasive imaging approaches over clinical,~          historical and stress test data for the prediction of all cause mortality. In addition,~          the ability of these modalities -together and separately- to risk stratify patients is a~          primary goal of specific aim 2.~   "
246893|NCT00321386|"~     To obtain demographic and baseline ophthalmic parameters (such as Intraocular Pressure~     profiles, disc morphological characteristics, central corneal thickness, peripapillary~     retinal nerve fibre layer thickness and its serial changes, visual field changes, severity of~     any medical associations—e.g. hypertension, migraine, strokes, silent cerebral infarcts) with~     non-invasive measurements, in Chinese Patients with Normal Tension Glaucoma~   "
246894|NCT00321373|"~     The purpose of this study is to evaluate the immune response and safety of influenza vaccine~     candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in~     elderly aged 60 years old and above.~   "
246895|NCT00321360|"~     Whether patient-maintained sedation (the patient controls his/her degree of sedation using a~     hand-held device) using the drug propofol is safer and more effective when using~     deteriorating reaction time as an added safeguard against the small potential for over~     sedation in a group of healthy volunteers.~   "
246896|NCT00321347|"~     Opioid medicines, like morphine, are the main treatment for severe cancer pain.~     Unfortunately, some patients suffer severe pain despite high doses of opioids. We hypothesize~     that intravenous lidocaine can quickly and effectively treat this kind of opioid-refractory~     pain.~   "
246897|NCT00321334|"~     The objective of the trial is to determine whether 3 cycles of TP (docetaxel plus cisplatin)~     after complete operation will improve survival when compared with 3 cycles of TP prior to~     complete resection for NSCLC.~   "
246898|NCT00321321|"~     The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone~     GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP~     channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the~     insulinotropic effect of GIP.~   "
246899|NCT00321308|"~     To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed~     for the treatment of patients with locally advanced or metastatic NSCLC who have failed one~     prior chemotherapy regimen~   "
246900|NCT00321295|"~     Congestive heart failure (CHF) is a medical condition that is due to left ventricular~     systolic dysfunction (LVSD). LVSD is a decreased ability of the heart to pump blood forward.~     There are 5 million people in the United States that have CHF and 52,828 new cases are~     diagnosed annually. There are 995,000 hospital visits and 52,828 deaths annually due to CHF.~     Previous studies have shown that people with this condition are at a higher risk for~     complications immediately after any type of heart surgery than are normal individuals. This~     includes increased dependence on medications and devices to improve the pumping function of~     the heart and blood pressure. Additionally, they also have longer lengths of hospital stay~     and higher rates of death compared to normal individuals.~      Some patients with LVSD not only have a decreased pumping ability of the heart, they also~     have an inefficient pumping function. These patients have been shown to benefit from a device~     therapy known as biventricular pacing. Biventricular pacing involves simultaneously~     electrically stimulating the two major pumping chambers of the heart known as ventricles~     using a pacemaker and wires. This causes a more coordinated contraction of the heart chambers~     resulting in improvement in the pumping ability of the heart and blood pressure. Studies have~     confirmed that in these patients, implantation of a biventricular pacemaker improves~     patients' symptoms and quality of life as well as decreasing a need for future~     hospitalizations. Whether biventricular pacing in patients with LVSD improves patient~     outcomes after heart surgery has not been investigated.~      Some patients temporarily develop slow heart rates after cardiovascular surgery. These slow~     heart rates can cause a decrease in the blood pumped from the heart and result in low blood~     pressures. Therefore, all patients undergoing cardiovascular surgery, regardless of left~     ventricular function, receive temporary pacing wires that are placed on one of the ventricles~     during the surgery. Temporary pacing will result in an increase in heart rate and improvement~     in the amount of blood pumped by the heart and in blood pressure. The placement of these~     wires is precautionary as only a few patients need to be paced for slow heart rates. Once~     patients are felt to no longer require them, the wires are easily removed. The purpose of~     this study is to determine whether biventricular pacing immediately after heart surgery in~     patients with LVSD will improve in-hospital outcomes.~      Patients that are scheduled for heart surgery and meet the inclusion criteria will be~     approached for consent to participate in this study. Once consented, they will be randomized~     to one of three treatment arms: usual care, RV pacing (single ventricle pacing), or~     biventricular pacing. Randomization is a process similar to picking numbers out of a hat. The~     patients will then undergo surgery as scheduled. During the surgery, the patients will~     receive the temporary pacing wires on both ventricles instead of one. Immediately after~     surgery, the patients will receive either usual care, RV pacing, or biventricular pacing~     depending upon the treatment arm that they were randomized to. The pacing wires will be~     removed as soon as the patients become stable as per routine. The clinical, operative, and~     in-hospital characteristics of these patients will be recorded on specialized forms. The~     characteristics of those that received biventricular pacing will be compared to those that~     had RV or no pacing to see whether there was any benefit to this mode of therapy.~   "
246901|NCT00321282|"~     Roughly thirty percent of people that undergo open heart surgery get an abnormal heart beat~     afterwards known as atrial fibrillation (AF). While not life threatening, this abnormal heart~     beat increases the likelihood of stroke and delays recovery. There are strategies to prevent~     post-operative AF, but they are costly and sometimes have undesirable side effects.~     Therefore, it would be best if we use these preventive treatments only in high risk patients.~      We intend to develop a risk prediction model based on demographic and electrocardiogram (ECG)~     findings that will predicted who is likely to get AF. We will develop this model using data~     already available on patients who have undergone cardiac surgery. The development of this~     model will use the latest mathematical algorithms similar to those used to study genetic~     evolution. This type of model is capable of looking at many parameters in an unbiased way, so~     that only the strongest, independent predictors remain in the final model. Once, the model is~     developed, we will validate the model by comparing our predictions to actual outcomes~     previously recorded in the database.~   "
246931|NCT00320879|"~     Aim: To evaluate the renoprotective effect as reflected by short-term changes in albuminuria~     of ultra high doses of irbesartan in Type 2 diabetic patients with microalbuminuria Design: A~     double-masked randomized cross-over trial including 60 hypertensive Type 2 diabetic patients~     with microalbuminuria on ongoing antihypertensive medication. At inclusion, previous~     antihypertensive treatment will be discontinued and replaced with bendroflumethiazide 5 mg~     o.d. for the entire study. Following two months wash-out (baseline), patients will be treated~     randomly with irbesartan 300, 600 and 900 mg o.d., each dose for two months. End-points~     evaluated at the end of each study period include urinary albumin excretion rate (UAE, mean~     of three 24-hrs collections), 24-hrs blood pressure (ABP); and GFR (51Cr-EDTA).~   "
246902|NCT00321269|"~     Patients with a diagnosis of CHF, NYHA class II, III or IV will be recruited for a study~     comparing a nursing intervention addressing CHF (SIM group) or CHF and depression (CIM~     group). Participants in the standard illness management program will receive an 8-week,~     8-session intervention designed to help them improve daily weighing, salt-restriction,~     medication management, etc. This intervention will be conducted in a combination of home~     visits and phone visits. They will also receive interactive, telephone-based daily monitoring~     that assesses daily weight, dyspnea, fatigue and medication compliance. Patients in the~     comorbid illness management program will receive the same illness management program PLUS~     education and behavioral techniques designed to help them cope emotionally with the illness.~     The comorbid illness management home monitoring will include a twice-monthly screen for~     depression. Major Variables: The major outcomes will be depressive symptoms, health-related~     quality of life, functional status, heart failure symptom severity, and self-care behaviors~     in heart failure.~   "
246903|NCT00321256|"~     This research project is supported by a multicentric network of collaborators whose goal is~     to assess the efficacy of transplanting allogenic pancreas islets to restore insulin~     secretion in patients with brittle type 1, insulin-dependent diabetes mellitus and to improve~     their metabolic control.~   "
246904|NCT00321243|"~     A four-level triage scale (the Geneva Emergency Triage Scale, GETS) has been used since 1997~     in our emergency department (ED). A recent evaluation of this scale showed that our~     instrument had an excellent intra-rater reliability but insufficient inter-rater reliability.~     We also observed a wide variability in the way triage nurses perform (J Clin Epidemiology,~     2006 in press). These variations in the triage process are mainly explained by a poor~     standardization of vital signs measurement. Therefore, we have recently modified our triage~     instrument and introduced explicit criteria for vital signs evaluation during the triage~     process.~      The objectives of this study are:~        -  To evaluate the inter- and intra-rater reliability of our modified triage scale using a~          computer simulator~        -  To measure the impact of visual clues on the triage decisions when using the triage~          simulator~        -  To evaluate the performance of triage nurses and chief physicians in their triage~          decisions.~      We expect to observe:~        -  an improvement of the inter-rater reliability of our instrument compared to the previous~          version~        -  a better standardization and more systematic use of vital signs measurement~        -  a higher reliability when visual clues are given to the evaluator~        -  lower rates of under- and over-estimation of emergency levels.~   "
246905|NCT00321230|"~     Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.~   "
246906|NCT00321217|"~     The main aim of this study is to identify genetic markers (at DNA and RNA level) which are~     involved in the response to treatment with monoclonal antibodies against TNF in patients with~     rheumatoid arthritis.~   "
246907|NCT00321204|"~     It is well known that abnormal heart beats from the top parts of the heart, atrial~     fibrillation (AF) and atrial flutter (Aflut), occur frequently after most types of cardiac~     surgeries. Postoperative AF and Aflut are associated with significant morbidity, longer~     hospital stay, and higher related costs. Currently therapies are marginally effective at~     preventing this abnormal heart beat. The incidence of abnormal heart beats after cardiac~     surgery seems to be a function of the amount of inflammation and oxidative stress induced.~     Our group and others have shown that atrial abnormal heart beats are associated with~     increased oxidative stress. Thiazolidinediones (TZDs) are medications used to treat diabetes.~     Beside their glucose lowering effects, TZDs are shown to exhibit anti-inflammatory and~     antioxidant properties. Therefore, we propose to retrospectively analyze the effect of~     pre-operative TZDs on the incidence of post-operative AF or Aflut. This study will involve~     retrospective chart reviews without further patient contact of all patients having undergone~     cardiac surgery in Emory University Hospital, Crawford Long Hospital, or the VA Medical~     Center from 2000 to 2005. This study is preparatory to a funding proposal for a prospective~     trial.~   "
246908|NCT00321191|"~     This study is investigating the second gas effect, a phenomenon produced by the uptake of~     nitrous oxide (N2O) by the lungs, during the course of a typical anaesthetic. The effect is~     to increase the concentration of other breathed gases in the lung. These include oxygen and~     volatile anaesthetic agents such as sevoflurane, which are also normally administered along~     with N2O. We wish to i) measure the magnitude of the second gas effects on both blood and~     expired concentrations of sevoflurane (Part 1), and ii) see if a demonstrable difference~     exists between the effects on blood and expired concentrations.~   "
246909|NCT00321178|"~     The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now~     advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily)~     along with surgery. This preliminary advice was based on observations in 21 patients with~     pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time.~     In patients treated with SR for at least 4 weeks, M. ulcerans could no longer be cultured~     from excised lesions. SR has been introduced without a formal evaluation or comparison with~     other treatments have been conducted or published, but the impression is that this treatment~     is beneficial and may cure BUD without additional surgical management.~      This study protocol evaluated the hypothesis that early, limited lesions of~     BUD(pre-ulcerative or ulcerated lesions, ≤ 10 cm maximum diameter), can be healed without~     recurrence using antimycobacterial drug therapy, without the need for debridement surgery.~      In endemic regions in Ghana, patients will be actively recruited and followed if ≥ 5 years of~     age, and with early (i.e., onset < 6 months) BUD.~        -  consent by patients and / or care givers / legal representatives~        -  clinical evaluation, and by~        -  analysis of three 0.3 cm punch biopsies under local anaesthesia.~        -  disease confirmation: dry reagent-based polymerase chain reaction (DRB-PCR IS2404)~        -  randomization: either SR for 8 weeks, or 4 weeks of SR followed by R and clarithromycin~          (C)~        -  stratification: ulcerative or pre-ulcerative lesions.~      Biopsies processed for histopathology, DRB-PCR-, microscopy, culture, genomic, and~     sensitivity tests. Lesions assessed regularly for progression or healing during treatment.~     Drug toxicity monitoring included blood cell counts, liver enzymes and renal tests; and ECG~     and audiographic tests.~      Primary endpoint: healing without recurrence at 12 months follow-up after start of treatment~     Secondary endpoint: reduction in lesion surface area and/or clinically assessed improvement~     on completion of treatment, averting the need for debridement surgery.~      Recurrences biopsied for confirmation, using PCR, histopathology, and culture. Sample size~     calculation: 2x74 fully evaluable patients; 80% power to detect a difference of 20 % in~     recurrence-free cure 12 months after start of treatment between the two groups (60 versus~     80%). A Data Safety and Monitoring Board made interim analysis assessments.~   "
246950|NCT00320619|"~     Individuals who undergo spine surgery often have a significant loss of blood and may require~     multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may~     reduce the amount of blood lost during surgery, which would decrease the number of blood~     transfusions required. This study will evaluate the safety and effectiveness of EACA at~     reducing blood loss and the need for blood transfusions in individuals undergoing spine~     surgery.~   "
246910|NCT00321165|"~     Total parenteral (intravenous) nutrition in the home setting (Home TPN or HPN) is a life~     saving strategy in patients who suffer from severe intestinal failure. Unfortunately, this~     treatment modality remains complicated by the development of frequent infectious~     complications. This especially relates to the device that is used to establish venous access,~     mostly a catheter (Hickman-Broviac type) or a port-a-cath.~      Taurolodine is an antimicrobial agent without any known side effects or resistance-related~     problems that holds promise as an effective antibiotic lock solution to prevent catheter~     infections, as demonstrated recently in a pilot study in HPN patients [Jurewitsch, 2005].~      In addition, recently a test has been described which may enable to confirm a suspected~     diagnosis of central line infection within one hour, the so-called Acridine Orange Leukocyte~     Cytospin test (AOLC) [Bong, 2003]. For this test, blood that is drawn from the central line~     is stained with the fluorescent dye acridine orange. Next, microscopic evaluation for the~     presence of micro-organisms takes place. Implementation of this test might enable to start~     treatment of the infection and prevent unnecessary removal of non-infected central lines~     without the necessity to several days wait for culture results.~   "
246911|NCT00321152|"~     The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin®) is safe and effective~     in relieving depression when it is added to standard kinds of antidepressants called~     serotonin reuptake inhibitors (SSRIs).~   "
246912|NCT00321139|"~     Blockages in the blood vessels of the heart are the main cause of chest pain, heart attacks,~     and sudden death. A cardiac catheterization, or injecting x-ray dye into the blood vessels of~     the heart and taking pictures, is currently the best way of assessing these blockages. This~     procedure, however, does not allow us to know what is happening inside the blockages. Some~     blockages have a higher risk of rupturing and completely blocking of the blood vessel while~     others are at low risk for doing this.~      Blood levels of different substances produced by the body have been shown to be associated~     with a higher risk of having chest pain, a heart attack, or sudden death. There is also~     evidence from studies in animals and tissues taken from humans during surgery that some of~     these substances are made in the blockages themselves.~      We would like to investigate whether a number of these substances are made in the blockages~     and released into the bloodstream. We will do this by taking one tablespoon samples of blood~     upstream and downstream of the blockages in the blood vessels of the heart. The samples will~     be obtained by using a very thin catheter, or plastic tubing, that is about 1/3 the size of~     the blood vessels of the heart. We will take samples from the tightest blockage found as well~     as another, less tight, blockage and compare the two. We will also sample blood from the~     tightest blockage after it is opened by doing an angioplasty. Finally, we will also take~     pictures of the blockages studied using a very small ultrasound camera inserted into the~     blood vessel. We will compare the levels of the substances measured with the features we see~     on the pictures.~      We hope to learn if some or all of the substances measured can identify which blockages are~     more at risk for rupturing and causing heart attacks and sudden death.~      All patients who are entered into this study will already be having an angioplasty done. The~     procedures needed for the study (sampling of blood and taking pictures with an ultrasound)~     are already often, though not always, used in patients undergoing an angioplasty.~   "
246913|NCT00321126|"~     Shigellosis is a major cause of morbidity and mortality in young children in Bangladesh and~     other developing countries. Further, the increasing emergence of resistance to a wide range~     of antibiotics is of great concern. Another major public health problem in Bangladesh is~     malnutrition, which is closely linked with shigellosis and with a high mortality. In~     Shigellosis, a heavy nutritional burden is placed on children and vital micronutrients such~     as vitamin A is lost in the urine. We recently found that the immune response in S. Flexneri~     infection was lower in children who were severely malnourished (weight-for-age≤65% as a~     percentage of the National Centre for Health Statistics median) when compared to children~     with weight-for-age from >65-75%. T cell responses were primarily affected with lowered~     CD4/CD8 ratios, lowered proliferative responses to T cell mitogens, Conconavalin A (ConA) and~     phytohaemagglutinin (PHA). However, proliferation of pheripheral blood mononuclear cells~     (PBMs) was lowered only in the presence of autologous plasma suggesting that a factor(s) in~     plasma, probably nutritional, rather than a defect in cells themselves was responsible. In~     children with S. dysenteriae 1 infection, proliferative responses to PHA were similarly~     lowered in the presence of autologous plasma but inhibition correlated to lowered~     transferring levels in plasma and not to the weight-for-age of the children. Also severely~     malnourished children with either S. flexneri or S. dysenteriae 1 infection were more~     severely ill. These findingings show that immunity in malnourishrd children with shigella~     infection is impaired which may lead to more severe illness. As zinc has profound effects on~     immunity as well as clinical outcome in diarrhoeal diseases, it is possible that zinc~     deficiency may be a factor in reducing immunity and increasing severity of acute illness in~     malnourished children with shigellosis. In this study, we will investigate the effect of zinc~     supplementation, in a double blind placebo controlled trial, on inflammatory responses,~     outcome of acute illness and growth following recovery from acute illness with S. flexneri~     infection.~   "
246914|NCT00321113|"~     The purpose of this study is to explore the safety and efficacy of two different~     immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids~     versus tacrolimus plus MMF, following induction with daclizumab) in recipients of marginal~     donor kidneys.~   "
246915|NCT00321100|"~     The purpose of this study is to determine the objective response rate of patients with~     previously untreated metastatic colorectal cancer treated with the combination of cetuximab,~     capecitabine, and oxaliplatin with out without bevacizumab.~   "
246916|NCT00321087|"~     This study will evaluate the safety and efficacy of T2000 when used to treat patients with~     moderate to severe essential tremor over a 20 week period.~      Essential tremor (ET) is a common form of involuntary shaking not related to Parkinson's~     disease. The medications that are currently used to treat ET work in a small proportion of~     patients and provide only partial improvement in symptoms. Use of these current medications~     is also limited by side-effects in many patients.~      T2000 is a medication currently under development for the treatment of essential tremor.~     Although T2000 is a new medication, it belongs to a class of medications that has been used~     for many years for the treatment of a variety of medical conditions. In previous studies,~     T2000 appeared to be effective in controlling symptoms of ET and some patients with severe ET~     had major improvements in tremor. T2000 was well tolerated for periods up to 20 days and the~     minimal side-effects seen were those that would be expected for medications in this class.~      The current study will evaluate the safety and efficacy of T2000 in patients with moderate to~     severe essential tremor. Patients will receive doses of T2000 beginning at 600 mg a day,~     followed by 800 mg a day and up to 1000 mg a day. The total duration of treatment will be 20~     weeks. Patient's tremor and neurological examination will be monitored throughout the study.~     The response to T2000 will be determined by comparing the severity of tremor while patients~     are receiving T2000 compared to the tremor observed without active medication.~   "
246917|NCT00321074|"~     The purpose of the study is to compare the safety and efficacy of two different tacrolimus~     based immunosuppressive regimens, one in combination with daclizumab, the other in~     combination with steroids, in recipients of suboptimal livers.~      Pharmacokinetics of tacrolimus and bile composition will be measured in a subgroup of~     patients.~   "
246951|NCT00320606|"~     Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ~     transplant recipients to prevent their bodies from rejecting the new organ. Long-term use of~     these drugs places transplant recipients at higher risk of serious infections and certain~     types of cancer. The purpose of this study is to determine whether immunosuppressive drugs~     can be safely withdrawn over a minimum of 9 months from children who received liver~     transplants at least 4 years ago.~   "
246918|NCT00321061|"~     This study will test whether a vaccination schedule of experimental HIV vaccines is safe and~     whether it causes side effects in healthy adult volunteers. It will also compare the effects~     of vaccine injected into the muscle (intramuscular), just under the skin (subcutaneous), or~     into the skin (intradermal) and will monitor the social impact of being in an HIV vaccine~     study.~      Healthy volunteers 18-50 years old may be eligible for this 42-week study. Participants are~     screened for antibodies to adenovirus, a common virus that causes upper respiratory~     infections, such as the common cold. Half of the participants selected will be positive and~     half will be negative for antibodies to the virus.~      The vaccines used in this study are known as VRC-HIVDNA016-00-VP (called the DNA vaccine)~     and VRC-HIVADV014-00-VP (called the rAd5 vaccine). The DNA vaccine codes for four HIV~     proteins. The rAd5 vaccine is made using an adenovirus that has been modified to contain DNA~     that codes for three HIV proteins. These vaccines cannot cause HIV or adenoviral infections.~      Participants are randomly assigned to one of six possible vaccination schedules that include~     prime and booster vaccines. The first vaccinations prime the immune system and the immune~     response is then boosted later. The groups differ in the type of vaccines given (DNA vaccine~     prime with rAd5 booster or rAd5 prime with rAd5 booster), in how the vaccine is administered~     (intramuscularly, subcutaneously or intradermally) and in the schedule of administration. All~     shots are given in the upper arm. Subjects fill out a diary card at home for 5 days after~     each vaccination, recording their temperature and any symptoms. The cards are turned in to~     the clinic at the first visit after all 5 days are completed. Subjects return for clinic~     visits about 3 days after each prime vaccination and either come in or call the clinic about~     7 days after the injection. They call a study nurse 1 or 2 days after the booster~     vaccination.~      Participants have 15-20 clinic visits during the course of the study, depending on their~     vaccination schedule. At each visit, they are checked for health changes or problems, asked~     how they are feeling and if they have taken any medications or other treatments, including~     over-the-counter medicines, herbal supplements, etc. Blood and urine samples are collected at~     some visits. Subjects are tested for HIV several times and asked questions about their sexual~     behavior and drug use. Throughout the stu...~   "
246919|NCT00321048|"~     Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for~     breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases~     radiation exposure to the heart during radiation for breast cancer. In this trial cardiac~     perfusion changes or lack thereof will be quantified in women treated with radiation for~     breast cancer while using the ABC device. The control group of the study will consist of~     patients randomized to radiation therapy without the ABC device.~   "
246920|NCT00321035|"~     The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix is~     effective and safe to implant as an aid of glaucoma and pterygium surgeries.~   "
246921|NCT00321022|"~     The primary objective of this study is to determine if emergency department patients with~     Transient Ischemic Attack (TIA) that are managed using a TIA accelerated diagnostic~     protocol, or ADP, demonstrate a significant decrease in their index visit length of stay~     and cost, with comparable diagnostic and 90-day clinical outcomes relative to TIA patients~     randomized to traditional inpatient care.~      The secondary objectives are to evaluate the potential role of a TIA risk stratification tool~     and to determine the time to a diagnostic endpoint in both groups.~   "
246922|NCT00321009|"~     To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of~     echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV~     mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.~   "
246923|NCT00320996|"~     SGO Society of Gynecologic Oncologists Data Outcomes Project.~   "
246924|NCT00320983|"~     A Phase I Study of Adjuvant Topotecan and Cisplatin with Concurrent Radiation Therapy for~     Advanced Cervical Cancer.~   "
246925|NCT00320970|"~     Diabetic nephropathy is a frequent microvascular complication that occurs in approximately~     40% of patients with either type 1 or type 2 diabetes. The most common cause of end-stage~     renal disease (ESRD) in the United States and in the developed world is diabetic nephropathy.~     Currently, more than half the United States ESRD population has diabetes. More effective~     therapies to prevent and treat diabetic nephropathy are urgently needed. One way to increase~     therapeutic effectiveness is to refine treatment targets based on improved understanding of~     how treatments modulate disease processes. The purpose of this study is to determine whether~     a treatment for diabetic nephropathy, the angiotensin receptor blocker candesartan, modifies~     mediators of kidney injury independent of blood pressure and the relationships to drug dose.~   "
246926|NCT00320957|"~     The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective~     and safe to implant as an aid of glaucoma surgery.~   "
246927|NCT00320931|"~     There have been many advances in the test used to look for heart disease. An example of this~     newer technology is the Multislice CT scan (MSCT) and Positron Emission Tomography (PET)~     scans.~      The use of this type of combined scan may show early coronary artery disease or the degree of~     damaged heart muscle form a heart attack with a single exam. It may help doctors to know who~     might benefit from heart surgery or angioplasty to increase the blood flow to the heart. This~     type of detailed images has previously been available only through cardiac catheterization.~   "
246928|NCT00320918|"~     Chart Review on Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM~     Cancer Center with a combination of irinotecan, capecitabine and celecoxib.~   "
246929|NCT00320905|"~     The proposed study will be the first to examine whether changes in blood flow patterns within~     the brain account for the possible cognitive benefits of CR. A clearer understanding of this~     possibility may provide key insight into the way CVD affects the brain, help identify~     effective treatments, help a greater number of patients return to work, and improve quality~     of life.~   "
246930|NCT00320892|"~     Dying patients are often unable to clear secretions from their large airways, resulting in~     noisy breathing usually described as death rattle. While there is no evidence that patients~     find this condition disturbing, the noises may be disturbing to the patient's visitors and~     caregivers who may fear that the patient is choking to death.~      In Israel none of the pharmaceutical drugs listed in the literature exist. Thus, Atropine~     drops which have been noted in the literature as being used, though according to our~     knowledge no evidence of clinical trials using sublingual Atropine were conducted.~      The study is designed as a randomly controlled, double blind crossover trial. The patient~     will serve as control for himself, as crossover between placebo and drug (randomly chosen)~     will take place. The administrator of the drug will be blinded to the medication, each time~     randomly beginning with a different drug (placebo or Atropine).~      We will evaluate Atropine Sulphate 1% ophthalmic drops effect on 33 patients using a noise~     score scale of 0-3. Noise scores will be taken at the start; 30 min after drug/placebo~     administration and every hour thereafter. After 4-hours crossover will take place and~     evaluation will follow the same protocol.~   "
246952|NCT00320593|"~     The purpose of the study is to determine if progressive addition lenses (PALs) versus single~     vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative~     responses (i.e., large accommodative lags) and near esophoria.~   "
246932|NCT00320866|"~     Background: Terminal patients are often unable to swallow and need medications to control~     symptoms. In these cases medications are administered continuously and subcutaneously by a~     syringe driver. A syringe driver is an expensive and sophisticated equipment to operate.~     Hypodermoclysis is a useful and easy alternative used in the homecare setting for hydration.~      Objectives:~        1. To assess the level of symptoms control by the administration of morphine,~          metoclopramide and midazolam by hypodermoclysis versus by a syringe driver.~        2. To assess the complications and side effects of infusing these medications continuously~          by hypodermoclysis versus by a syringe driver.~      Methods: Patients in the homecare setting who meet the criteria for parentral infusion and~     suffer: pain, vomit/nausea and/or agitation will be recruited for the study.~      A double blind crossover methodology will be used. Each patient will serve as both~     intervention and control, and both patient and medical staff will be blinded to the~     medication route administration. A research nurse will administer the medications. Crossover~     will take place 48 hours thereafter. A research assistant will conduct evaluation of symptoms~     and side effects for a period of 4 days. A sample size of 27 patients will be included in the~     study (calculated for a significance level of 95% and power of 80%).~   "
246933|NCT00320853|"~     The purpose of the study is to evaluate the change in insulin sensitivity and secretion~     indices (early markers for development of diabetes) after 4 weeks of a megadose of Vitamin D.~     This will also help to calculate sample size for and choose an appropriate index for a larger~     randomized control trial which may be required subsequently.~   "
246934|NCT00320840|"~     To evaluate the contribution of internal and familial resources on the development of~     motherhood in a population of mothers having preterm twin infants and comparing this~     population to a population of mothers giving birth to single (or twins) full term infants.~   "
246935|NCT00320827|"~     This is a dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the~     recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six~     weeks and possibly up to 12 weeks depending on response.~   "
246936|NCT00320814|"~     To assess the ocular and systemic safety and tolerability of a single intravitreal injection~     of VEGF Trap in patients with diabetic macular edema.~   "
246937|NCT00320801|"~     The original objective of this study was to demonstrate the effectiveness and tolerability of~     the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the~     buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis~     pain currently treated with oral opioids. The double-blind treatment intervention duration is~     12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen)~     will be provided to all subjects in addition to study drug.~      This study was terminated early due to administrative reasons with only 20% of the planned~     sample size; therefore, the primary objective was changed to focus on the safety evaluation.~   "
246938|NCT00320788|"~     This study examines the effect of intravitreally administered VEGF Trap in patients with wet~     AMD.~      The purpose of this trial is to assess the ocular and systemic safety and tolerability of~     repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal~     neovascularization (CNV) due to AMD.~   "
246939|NCT00320775|"~     The purpose of this trial is to assess the ocular and systemic safety and tolerability of a~     single intravitreal injection of VEGF Trap in patients with subfoveal choroidal~     neovascularization (CNV) due to AMD.~   "
246940|NCT00320762|"~     The purpose of this study is to determine whether the OculusGen Collagen Matrix is effective~     and safe to implant as an aid of glaucoma and pterygium surgeries.~   "
246941|NCT00320749|"~     The primary purpose of this study is to define the maximum tolerated dose of combination~     docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects~     will be measured in study participants. In addition, researchers will assess data about~     preliminary efficacy in patients with this treatment approach.~   "
246942|NCT00320736|"~     This study is a double-blind, placebo-controlled trial of the nicotinic receptor agonist,~     galantamine, for the improvement of memory and attention in people with schizophrenia and~     schizoaffective disorder. Twenty subjects on a stable dose of antipsychotic medications~     receive galantamine or identical placebo tablets for 8 weeks. Adverse events are screened for~     every week. Tests of memory, attention, and reward responsivity are performed at baseline and~     afer 8 weeks on medication. Clinical scales rating psychiatric symptoms are performed at the~     beginning, middle, and end of the trial.~   "
246943|NCT00320723|"~     This proposal seeks to evaluate a pilot smoking cessation treatment program that will combine~     nicotine replacement therapy with or without bupropion sustained-release (SR) with cognitive~     behavioral therapy for smoking cessation in patients with major mental illness.~   "
246944|NCT00320710|"~     Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1~     year with a standard zoledronic acid regimen. Looking at the continued effectiveness and~     safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This~     study is prospective, double-blind, stratified, multi-center, and two-arm.~   "
246945|NCT00320697|"~     This study seeks to determine if continued treatment with bupropion and nicotine replacement~     therapy (NRT) can reduce the smoking relapse rate in patients with schizophrenia.~   "
246946|NCT00320684|"~     This study will compare the concentrations of serotonin transporter in the brains of women~     with a history of anorexia nervosa who are currently maintaining a normal weight to those of~     healthy women of normal weight.~   "
246947|NCT00320671|"~     This 52 week long study evaluates the effectiveness of aripiprazole versus risperidone in~     treating people with first-episode schizophrenia. Patients who do not improve with these~     medications receive clozapine as their third medication trial.~   "
246948|NCT00320658|"~     The purpose of this study is to determine the safety of and immune response to a preventive~     malaria vaccine, MSP1 42-C1/Alhydrogel, in healthy adults. This study will also compare~     responses to two different doses of the malaria vaccine given with or without the adjuvant~     CPG 7909.~   "
246949|NCT00320632|"~     This study will determine the effectiveness of desipramine in improving cellular signaling,~     and thereby decreasing symptoms of depression in people with major depressive disorder (MDD).~   "
246953|NCT00320580|"~     The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl~     estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given~     in a traditional cyclic regimen~   "
246958|NCT00320515|"~     This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin~     for patients with unresectable, advanced gastric cancer who had no prior palliative~     chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase~     2, which has been completed and now a total of 60 qualified patients will be enrolled in the~     phase 2 of this study. The treating physician will determined the maximum number of cycles of~     pemetrexed plus cisplatin that a patient may receive in this study.~   "
246959|NCT00320502|"~     The purpose of this study is to determine the safety and feasibility of BXT-51072 as a~     cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous~     intervention (PCI), a procedure to open coronary arteries.~      BXT-51072 belongs to a class of drugs called glutathione peroxidase mimics. BXT-51072 works~     by imitating a substance produced in various tissues in the body, which prevents damage of~     the heart and blood vessels.~   "
246960|NCT00320489|"~     To compare the health outcome of patients with schizophrenia, who are at risk for relapse,~     when treated with a long acting injection form of olanzapine versus treatment with oral~     olanzapine.~   "
246961|NCT00320476|"~     Multiple Myeloma is a incurable disease. Recently developed targeted therapy gave new hope~     for the patients with multiple myeloma. Velcade in combination with other agents are~     currently in trials for the newly diagnosed patient, we designed sequential treatment with~     VTD and MPT for the patients who are not transplant candidates. This would be expected to~     result in maximal tumor control, and thus, in maximal survival benefit, equivalent to high~     dose therapy with autologous transplantation in younger population~   "
246962|NCT00320463|"~     In this study, infants will be randomly allocated into three groups:~        -  one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)~        -  the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)~        -  the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be~          double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current~          formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV~          vaccine.~   "
246963|NCT00320450|"~     The purpose of this research is to find out how effective and safe SB-681323 will be in the~     treatment of RA when it is added to standard anti-rheumatic treatments.~   "
246964|NCT00320437|"~     Our aim is examine avenues by which mothers can transmit their trauma to their children.~   "
246965|NCT00320424|"~     This study is requested by PMDA to confirm the efficacy and the safety for HFS.~   "
246966|NCT00320411|"~     This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in~     patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2~     overexpressing tumors and are refractory to treatment with anthracycline, taxanes and~     trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with~     the data from EGF100642 and integrated analysis will be carried out in order to enhance the~     credibility of the study results.~   "
246967|NCT00320398|"~     This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).~   "
246968|NCT00320385|"~     This study will evaluate and compare the safety and efficacy of lapatinib in combination with~     trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast~     cancer.~   "
246969|NCT00320372|"~     This registry will collect information about patients with treatment-resistant depression~     (TRD) who are currently in a major depressive episode. For the purposes of this study, TRD is~     defined as an ongoing depression lasting at least 2 years or that has recurred at least 3~     times, to include the current episode, during the patient's lifetime AND has not adequately~     responded to 4 or more adequate antidepressive treatments. The registry will follow the~     clinical course and outcomes for patients with TRD who are treated with and without~     adjunctive (used along with other treatments for depression) vagus nerve stimulation (VNS)~     therapy.~   "
246970|NCT00320359|"~     Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st~     line Small Cell Lung Cancer~   "
246971|NCT00320346|"~     The World Health Organisation has warned that an influenza pandemic is inevitable. The avian~     influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic.~     This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in~     healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza~     Vaccine.~   "
246972|NCT00320333|"~     Pulmonary rehabilitation of COPD patients are implemented in a non-randomized manner in two~     settings: primary and secondary health care. The effect on quality of life and~     hospitalizations will be evaluated~   "
246973|NCT00320320|"~     The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI~     discontinuation after initial 8 cycles and reintroduction after progression.~   "
246974|NCT00320307|"~     The purpose of the study is to look at the levels of the drug abacavir (ABC) in blood. Also,~     the study will look at the levels of carbovir triphosphate (CBV-TP), which is the active~     substance produced from ABC in the bodyâ s cells which helps prevent HIV from multiplying.~     CBV-TP will be measured in specific blood cells. The amount of ABC and CBV-TP will be looked~     at when subjects receive ABC as a 300mg dose twice a day and compared with the levels when~     they receive ABC as a 600mg dose once a day.~   "
246975|NCT00320294|"~     To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin~     (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.~   "
246991|NCT00320086|"~     The purpose of the study is to learn more about Microalbuminuria in children with and without~     diabetes. Albumin is a protein that may be excreted in the urine. In some conditions, like~     kidney problems or diabetes, the amount of albumin in the urine increases. The purpose of~     this study is to measure concentration of albumin in the urine of diabetic children and~     compare to healthy children.~   "
246992|NCT00320073|"~     RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Erlotinib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving vinflunine together with erlotinib or pemetrexed may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vinflunine when~     given together with erlotinib or pemetrexed in treating patients with unresectable or~     metastatic solid tumors.~   "
246976|NCT00320281|"~     As clinicians, it is often a struggle to find effective pain control for a certain subgroup~     of patients with tetraplegia. These patients often have severe upper back, neck, and shoulder~     pain, limiting rehabilitation productivity and potential, and always limiting quality of~     life.~      This pain appears to be primarily musculoskeletal. Muscles in the upper back and neck become~     shortened, rock hard, and extremely tender with even the slightest touch or stretch.~     Refractory to multiple classes of medications, modalities, and other treatments, patients~     truly suffer-not only from pain, but from fatigue, sedation, expense, and loss of useful~     rehabilitation time due to attempted remedies. Unfortunately, this subgroup of patients is~     not small and the problem is significant, as anyone who specializes in the treatment of~     spinal cord injury patients will recognize.~      In search for another form of treatment, botulinum toxin A (BTXA) may be promising for pain~     control in that group of patients with tetraplegia whose pain has proven to be refractory to~     treatment. It did not take long searching the literature to find compelling evidence that~     BTXA may have another mechanism of action for direct pain control, apart from its well known~     mechanism for spasticity control. Clinically, it is increasingly being recommended and used~     for this purpose. In fact, one of the specific indications now recognized by most for BTXA~     treatment is for myogenic pain due to short, tight, strained muscles-just as we see with our~     population. Yet, it's application has not been studied in people with tetraplegia. Thus, the~     genesis of the project and the hope to help our patients evolved.~      Study hypotheses:~        -  In addition to traditional treatments used for pain control, injection of BTXA into~          cervical and upper back muscles will effectively reduce cervical/shoulder pain severity~          reported by individuals with cervical spinal cord injuries, regardless of the etiology~          of pain.~        -  Pain reduction secondary to the use of BTXA will be associated with a decrease in total~          analgesic medication use among SCI patients during acute inpatient rehabilitation.~        -  BTXA to treat cervical/shoulder pain will increase active participation in the~          rehabilitation program for individuals with tetraplegia during inpatient rehabilitation.~   "
246977|NCT00320268|"~     This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and~     safe in the treatment of patients with MDD.~   "
246978|NCT00320255|"~     The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as~     anticoagulant therapy, when administered to patients with advanced or metastatic cancer and~     at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk~     profile could lead to significant reduction in this serious and sometimes fatal complication~     of ongoing cancer and its treatment.~   "
246979|NCT00320242|"~     The purpose of this study is to gather data to see if the Laser Cane and/or U-Step Walker~     with laser accessory is more effective in aiding with gait freezing than a regular~     cane/U-Step Walker in patients who have idiopathic Parkinson's disease.~   "
246980|NCT00320229|"~     The aim of our study was to demonstrate that, during a percutaneous coronary intervention,~     even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid~     thrombus resolution and clinical improvement without concomitant differences in hemorrhagic~     complications~   "
246981|NCT00320216|"~     The purpose of this study is to evaluate the efficacy and safety of initial single and~     multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to~     severe plaque psoriasis.~   "
246982|NCT00320203|"~     The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a~     single administration of Anecortave Acetate Depot for treatment of elevated intraocular~     pressure (IOP) in patients with open-angle glaucoma.~   "
246983|NCT00320190|"~     The purpose of this study is to compare the efficacy of dasatinib with that of high-dose~     (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved~     only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The~     safety of these treatments will also be evaluated.~   "
246984|NCT00320177|"~     This study will explore the eating habits of children and determine if eating behavior is~     linked to genetics.~      Children between 8 and 17 years of age may be eligible for this study. It will include~     children who have experienced loss of control over eating, children who report overeating~     without loss of control, and children who report experiencing neither of the above.~     Candidates will be screened with the following:~        -  Medical history and brief physical examination, including height, weight, and body fat~          measurements. Body fat is measured using a device called a Bod Pod. The child sits~          inside the device for about 5 minutes and the machine determines body fat by measuring~          air movement. The child must wear a tight-fitting swimsuit for this test.~        -  Urine test to look for sugar or protein in the urine and to test for pregnancy in~          females.~        -  Blood tests for routine chemistries and for gene studies related to eating behaviors.~        -  Questionnaires and interviews about the child's general health and eating habits.~        -  Acclimatization to test meal conditions for the study. The child is given a yogurt shake~          to drink and fills out rating scales before and after the drink.~      Participants will come to the Clinical Center two times at 8:30 a.m. for laboratory meal~     testing. At each visit, the child will do the following:~        -  In the morning, eat a breakfast of apple juice and a buttered English muffin.~        -  Between 10 a.m. and 2 p.m., pursue activities at the Clinical Center recreation facility~          or the NIH classroom, but may not eat or drink anything that contains calories.~        -  At 2 p.m., fill out rating scales about his or her hunger level.~        -  At 2:30 p.m., eat from a food buffet that will be made available.~        -  After eating, repeat rating scales about hunger level.~      The procedure for both visits will be the same, except at one visit the child will be~     instructed to eat as much as you would eat at a normal meal, and at the other visit, the~     instruction will be to let yourself go and eat as much as you want.~   "
246985|NCT00320164|"~     This protocol aims to collect human peripheral blood mononuclear cells for the production of~     dendritic cells (DC). There are two ways to collect human peripheral blood mononuclear cells~     in this protocol. One is by using the method of leukapheresis from normal healthy adults. The~     other is by drawing the blood from normal healthy adults and then getting the buffy coats~     from the blood.~   "
246986|NCT00320151|"~     This protocol is designed to gather a small amount of blood from patients seen in the New~     York Presbyterian Hospital-Weill Cornell Medical Center Pulmonary, Critical Care unit, and 5~     West floor (Pulmonary Floor) for clinical care associated with chronic lung disease. This~     protocol will also survey medical records of patients with chronic lung disease, in order to~     study the clinical characteristics of these individuals. Investigators aim to understand the~     genetics of chronic lung diseases, and will use the serum and DNA from this blood to perform~     various genotyping studies such as such as genomic/gene expression studies of individuals~     with chronic lung diseases~   "
246987|NCT00320138|"~     The purpose of this study is to determine the effectiveness of acupuncture as a treatment for~     Posttraumatic Stress Disorder (PTSD) among military personnel.~   "
246988|NCT00320125|"~     The purpose of the study is to evaluate the effects of different dietary calcium have on the~     pregnant teen mother and her newborn. We hypothesize that the higher calcium intake during~     pregnancy will result in higher bone mass in the newborn.~   "
246989|NCT00320112|"~     VA diabetes patients often have difficulty managing their self-care and accessing~     clinic-based services; many also lack social support to help them meet the demands of their~     illness. Enhanced support is especially important when undertaking and sustaining new~     challenging self-care tasks, such as initiating or intensifying insulin treatment regimens.~     Although some VAs have implemented telephone nurse care management programs supported by~     automated calling services, many are reluctant to adopt these models due to nursing~     shortages.~   "
246995|NCT00320034|"~     The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer,~     albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol~     which are mirror images of each other i.e. R-and S- isomers. The investigational treatments~     are R-albuterol and S-albuterol.~      R-albuterol ( levalbuterol) has been shown to have a slightly better bronchodilator effect as~     compared to the racemic albuterol and is well- tolerated in patients. However it is still not~     clear whether the S-isomer has no effect or has a harmful effect on the airways.~      The purpose of this study is to compare the effects of the R- and S- isomers on allergen~     induced airway inflammation in subjects with mild atopic asthma. This will give us a better~     idea as to whether the routine use of levalbuterol is superior to racemic albuterol.~   "
246996|NCT00320021|"~     The primary objective of the study is to evaluate the safety, tolerability and efficacy of~     Pyridorin (pyridoxamine dihydrochloride) up to 250 mg given orally twice daily in patients~     with diabetic kidney disease.~   "
246997|NCT00320008|"~     The purpose of this study is to determine whether intensified multifactorial intervention~     comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic~     complications compared to standard treatment in patients with type 2 diabetes and~     microalbuminuria.~   "
246998|NCT00319995|"~     This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study~     with a screening period. Subjects will receive one of the following three treatment groups~     for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or~     placebo. The primary objective of this study is to assess the efficacy of the combination of~     loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg~     montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in~     relieving the symptom of nasal congestion. The safety profile of combined~     loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.~   "
246999|NCT00319982|"~     This is a pilot clinical trial to assess whether the administration of diltiazem may be able~     to decrease the development or progression of hypertrophic cardiomyopathy (HCM). Diltiazem is~     a commonly used medication for the treatment of high blood pressure and studies on animals~     with HCM suggest that diltiazem decreases disease development. This study specifically~     targets individuals in the prehypertrophic phase of HCM-- those with documented sarcomere~     gene mutations without echocardiographic or EKG evidence of LVH, and therefore without a~     clinical diagnosis of HCM.~      The hypothesis of this study is that starting diltiazem administration early in life (in the~     prehypertrophic phase) will decrease the progression of HCM in individuals with sarcomere~     gene mutations. This will be assessed by looking at an improvement in the heart's ability to~     relax using echocardiography, as well as exploratory analyses of a broad range of features~     reflecting the heart's structure and function.~   "
247000|NCT00319969|"~     The purpose of the study is to evaluate the objective tumor response rate of amrubicin or~     standard topotecan therapy when administered as second-line therapy to ED-SCLC patients who~     have chemotherapy sensitive recurrent or progressive.~   "
247001|NCT00319956|"~     The hypothesis of this study is that administration of azithromycin to ventilated premature~     infants will decrease the incidence and severity of BPD.~      The purpose of this study is to determine if Azithromycin treatment is beneficial for~     prevention of bronchopulmonary dysplasia in preterm infants.~   "
247002|NCT00319943|"~     The purpose of this study is to determine the neuropsychological and neurophysiological~     impacts of a computer-based training program designed to improve the cognitive performance of~     patients with mild cognitive impairment (MCI).~   "
247003|NCT00319930|"~     The purpose of the study is to evaluate the effects of increasing doses of CNF1010 on~     pharmacodynamic markers and hematological response.~   "
247004|NCT00319917|"~     The purpose of the study is to assess the efficacy on joint damage and safety in RA patients~     treated with DMARDs in a double blind, placebo controlled study.~   "
247005|NCT00319904|"~     We will collect DNA from 500 rigorously diagnosed patients with schizophrenia to allow us in~     the future to examine phenotypic subtypes in relation to genetic variants. Phenotypes will~     include subgroups based on clinical symptoms, medication response, or other biological~     markers including neuroimaging or pharmacologic challenges.~   "
247006|NCT00319891|"~     The primary objective of this study is to evaluate the effects of computer-based training~     program (HiFi-AD) on the memory and cognitive abilities of individuals diagnosed with mild~     Alzheimer's Disease (AD).~   "
247007|NCT00319878|"~     Aplastic anemia is a rare autoimmune disorder in which the bone marrow production of blood~     cells is greatly decreased or absent. Symptoms include fatigue, weakness, tiny reddish-purple~     marks on the skin, abnormal bruising, and bleeding from the gums, nose, or intestine. While~     some cases of aplastic anemia are caused by medications, toxic exposures, or inherited genes,~     most often the cause remains unknown. The purpose of this study is to determine the safety~     and efficacy of combining two drugs, sirolimus and cyclosporine, for treating individuals~     with aplastic anemia that has not responded to other treatments.~   "
247008|NCT00319865|"~     Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.~   "
247009|NCT00319852|"~     The present clinical study will assess the immunogenicity and reactogenicity of Sanofi~     Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months~     of age compared to commercially available vaccines in order to meet the requirements for~     registration of the product in South Korea.~      Primary objective To demonstrate the non-inferiority in terms of seroprotection rates~     (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to~     Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus~     commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV~     (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination.~      Secondary objectives~        1. Immunogenicity: To assess the non-inferiority in terms of seroprotection rates~          (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response~          rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine~          versus historical reference (Study E2I03294 - France). To assess and describe the~          immunogenicity of the study vaccines in both groups.~        2. Safety: To assess and describe the safety of the study vaccines after each dose.~   "
247010|NCT00319839|"~     Primary Objective: To assess the overall response rate (complete and partial response) to~     Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of~     Cetuximab on disease progression.~      Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United~     States (Jemal et al, 2003), and over 30% of these patients are expected to die of their~     malignancy. Squamous cell carcinoma accounts for more than 90% of head and neck cancer cases.~     Although metastatic disease at the time of diagnosis is rather uncommon, and despite~     aggressive use of up-front concurrent radiation and cisplatin-based chemotherapy,~     approximately 20% of the patients will develop metastases. Patients with recurrent or~     metastatic squamous cell carcinoma of the head and neck (SCCHN) have a poor prognosis~      A subsequent randomized study conducted by ECOG (E1393) compared high-dose paclitaxel (200~     mg/m2) as a 24-hour infusion plus cisplatin 75 mg/m2 with G-CSF support, to low dose~     paclitaxel (135 mg/m2) as a 24-hour infusion, plus cisplatin 75 mg/m2 (Forastiere et al,~     2001). Patients with newly diagnosed metastatic or recurrent squamous cell carcinoma of the~     head and neck, excluding nasopharyngeal primaries were eligible. No prior treatment for~     recurrent/metastatic disease was allowed, but patients could have received chemotherapy as a~     part of the initial curative therapy that should have been completed 6 months prior to study.~      No statistically significant difference could be demonstrated either in response rates or~     survival between the two arms (Murphy et al, 2001). This study, however, indicated that~     paclitaxel, a member of the taxane class of anti-tumor agent, is active in head and neck~     cancer.~      New agents to treat head and neck cancer need to be investigated. Abraxane, an albumin-bound~     formulation of paclitaxel has shown significant single-agent activity in breast cancer and in~     head and neck cancer. Recently, Abraxane has approved for use in metastatic breast cancer.~     Given previous randomized phase III trials indicated single agent chemotherapy fared as well~     as combination chemotherapy regimen in terms of overall survival, this novel formulation~     should be actively investigated in head and neck cancer.~   "
247011|NCT00319826|"~     The purpose of this study is to investigate why some people develop life-threatening~     infections caused by the bacteria Staphylococcus aureus, while other people do not. It is~     possible that the infectious ability of the bacteria can determine whether an infection~     develops and its severity. The investigators will look at old blood and nasal specimens~     collected from 1000 adults who had S. aureus infections and who were hospitalized at Duke~     University Medical Center. Previously collected health information regarding these patients~     and the specific bacterial traits in the samples will be studied. Eventually this information~     may be used to help treat and prevent S. aureus infection.~   "
247012|NCT00319813|"~     A Cross sectional observational Quality Assurance Project in General Practice to COPD~     Diagnosis and Treatment~   "
247013|NCT00319800|"~     To determine whether in docetaxel pretreated advanced NSCLC patients with favorable clinical~     parameter(s) gefitinib can produce different outcomes from patients without favorable~     clinical parameter treated with irinotecan.~   "
247014|NCT00319787|"~     The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard~     treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a~     difference in the rate of decrease of prostate specific antigen (PSA) levels.~   "
247015|NCT00319774|"~     Volume overload contributes significantly to the pathogenesis of hypertension in hemodialysis~     patients. The Hemocontrol(HC)system (Gambro), which automatically adjusts ultrafiltration~     rate and dialysate conductivity according to blood volume variations during dialysis, has~     been suggested to improve hemodynamic tolerance and thus facilitate fluid removal.~      This randomized controlled trial was designed to compare the use of HC with standard~     hemodialysis to test the hypothesis that the use of the HC system may lower home blood~     pressure in comparison with standard hemodialysis as a primary endpoint. Secondary endpoints~     are a variation in the percentage of dialysis sessions requiring nurses’ interventions for~     intra-dialytic hypotension and a change in the health-related quality of life of HD patients.~   "
247016|NCT00319761|"~     Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in~     the world. A wealth of literature suggests that vitamin D and its analogs have profound~     effects on immune system function and glomerular mesangial cell proliferation. Calcitriol, an~     active form of vitamin D, is commonly used for the treatment of secondary hyperparathyroidism~     in patients with advanced chronic kidney diseases. Therefore, the investigators plan to~     conduct a open-label single-arm study to evaluate the safety and efficacy of calcitriol in~     the treatment of IgA nephropathy. Ten patients with biopsy-proven IgA nephropathy and~     persistent proteinuria despite conventional therapy will be recruited. They will be treated~     with calcitriol for 12 weeks. Proteinuria, renal function, serum and urinary inflammatory~     markers will be monitored. This study will explore the potential anti-proteinuric and~     anti-inflammatory effects of calcitriol in the treatment of IgA nephropathy, which is a major~     cause of dialysis-dependent renal failure.~   "
247017|NCT00319748|"~     The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat~     metastatic breast, ovarian, endometrial or cervical cancer not responding to standard~     treatment.~   "
247018|NCT00319735|"~     The interaction of epidermal growth factor receptor (EGFR) inhibitory agents such as~     cetuximab combined with radiation shows promising results. EGFR inhibitory agents also~     enhance radiation-induced apoptosis and inhibit radiation induced damage repair. These~     interactions may represent the principle effects that contribute to the synergy between EGFR~     and radiation.~      This trial will investigate the feasibility and activity of this combination in patients with~     surgically resectable disease.~   "
247019|NCT00319722|"~     This study uses EEG to study brain waves at rest and in response to specific auditory and~     visual sensory stimuli in autistic children. We hypothesize that, compared to same age peers,~     autistics will show abnormalities in their electrophysiologic processing of sounds (tones and~     phonemes)and visual stimuli (flashes of light)and that these abnormalities will be able to~     separate autistics not only from typical children but also into clinical subgroups with~     specific biological/electrophysiological characteristics. We hope to find biological measures~     which will prove diagnostic of autism in very young children and which can be used in the~     measurement of treatment outcome in future intervention trials.~   "
247020|NCT00319709|"~     The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly~     patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose~     of SR58611A compared to placebo in elderly patients with depression. The secondary objectives~     are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability~     and quality of life in elderly patients with depression.~   "
247021|NCT00319696|"~     The aim of the study is to collect long-term efficacy, tolerability and safety data of~     bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).~   "
247022|NCT00319683|"~     5-fluorouracil (5-FU), one of the most actively investigated anti-cancer drugs, is rapidly~     inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This~     study will test the safety and effects of oral ADH300004 14 hours prior to oral 5-FU in~     subjects with locally advanced, recurrent, or metastatic hepatocellular carcinoma.~   "
247024|NCT00319657|"~     The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone~     Marrow Transplantation are enrolling patients into a research study to determine if blood~     stem cells injected after kidney transplantation, in combination with lymphoid irradiation~     ,will change the immune system such that immunosuppressive drugs can be completely withdrawn.~     Patients must have a healthy, completely human leukocyte antigen (HLA)-matched brother or~     sister as the organ and stem cell donor.~      One to two months before kidney transplant surgery, blood stem cells will be removed from the~     donor and the cells will be frozen. After transplant surgery, the recipient will receive~     radiation and anti-T cell antibody treatments for two weeks to prepare for injection of the~     stem cells. The stem cells will be injected at the end of the two-week treatment. If the stem~     cells persist in the recipient, immunosuppressive drugs will be gradually reduced until they~     are withdrawn completely at least six months after transplantation. Patients will be followed~     in the Stanford clinics for transplant patients. Patients who live outside of the San~     Francisco Bay Area must remain near Stanford for six weeks after transplant surgery.~   "
247025|NCT00319644|"~     The proposed study will evaluate adult patients admitted to the medical or surgical intensive~     care units (ICUs) at San Francisco General Hospital (SFGH). On admission, patients will be~     randomized in a 1:1 manner to the mini-bronchoalveolar lavage (BAL) quantitative culture arm~     in the setting of suspected ventilator-associated pneumonia (VAP) versus the tracheal~     aspirate culture arm, which is the current test available at SFGH.~   "
247026|NCT00319631|"~     Understanding the role VEGF plays in ARDS consequently provides an ideal opportunity to~     discover new therapies for ARDS.~   "
247027|NCT00319618|"~     The purpose of this study is to determine if combination therapy of weekly Taxotere™ with~     Iressa™ will increase the objective responses in measurable leasions in metastatic breast~     cancer~   "
247028|NCT00319605|"~     Phase IV, observational, post-authorization, cross sectional, open-label, multicenter study~     to evaluate the acceptability of oral solution of levetiracetam in patients with partial~     epilepsy as assessed by a questionnaire.~   "
247029|NCT00319592|"~     The purpose of this study is to determine non-inferiority in seroconversion and to compare~     the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous~     virus strain and several wild types strains after completion of vaccination course.~   "
247030|NCT00319579|"~     Kidney transplantation, a 'miracle' of modern medicine, is the preferred treatment option for~     End Stage Renal Disease compared to dialysis, patients who receive kidneys have a 70%~     reduction in risk of death, a dramatically improved quality of life and cost the health care~     system considerably less. As a result there are over 3000 Canadians, and 57,000 Americans on~     the waiting list for a kidney. To meet the shortage in cadaveric kidneys, rates of living~     kidney donation have nearly doubled over the last 10 years, and will continue to rise with~     growing demand.~      Yet despite its advantages for the recipient, living kidney donation remains a complex~     ethical, moral and medical issue. The premise for accepting living donors is that the~     minimal risk of short and long-term medical harm realized by the donor is outweighed by the~     definite advantages to the recipient and potential psychosocial benefits of the altruistic~     gift to the donor. The only benefit for the living donor is psychological - donors experience~     increased self-esteem, feelings of well-being and improved health related quality of life~     with their altruistic act of assuming medical risk to help another. The short-term~     consequences of living donation are well established. On the other hand the long-term~     implications of living kidney donation are far less certain. This study will look at the long~     term implications of living kidney donation.~   "
247031|NCT00319566|"~     The purpose of the study is to determine whether hormone replacement therapy in post~     menopausal women with coronary artery disease prevents future heart attacks or death from~     coronary heart disease.~   "
247032|NCT00319553|"~     This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and~     BOOSTRIX® vaccines among US adolescents.~   "
247033|NCT00319540|"~     The purpose of the study is to test the efficacy of a psychoeducational group program on~     unipolar depression~   "
247034|NCT00319527|"~     Kidney transplantation, is the preferred treatment option of end stage renal disease.~     Compared to dialysis, patients who receive kidneys have a 70% reduction in death, a~     dramatically improved quality of life and cost the health care system considerably less. As a~     result, there are over 3000 Canadians on the waiting list for a kidney. In order to meet the~     shortage of cadaveric kidneys, the rates of living kidney donation have nearly doubled over~     the last 10 years. Yet despite its advantages for the recipient, living kidney donation~     remains a complex ethical, moral, and medical issue. The premise for accepting living donors~     is that the minimal risk of short and long-term medical harm realized by the donor is~     outweighed by the definite advantages to the recipient and potential psychosocial benefits of~     the altruistic gift to the donor. The only benefit for the living donor is psychological -~     donors experience increased self-esteem, feelings of well-being, and improved health related~     quality of life with their altruistic act of assuming medical risk to help another. The~     short-term consequences of living donation are well established. On the other hand the~     long-term consequences of living kidney donation are far less certain. The main medical~     concerns of living kidney donation include an increased risk of hypertension, proteinuria,~     and low glomerular filtration rate (GFR- a measure of the filtering capacity of the kidney).~     Estimates of these outcomes are variable, inconsistent, and uncertain in the literature. This~     study is designed to quantify the long-term medical and psychosocial implications of living~     kidney donation.~   "
247035|NCT00319514|"~     To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules~     in patients with previously untreated, advanced NSCLC.~   "
247036|NCT00319501|"~     To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in~     selected patients who require intermittent medical intervention for the control of episodes~     of acute repetitive seizures. In addition, to assess the support provided by caregivers who~     are not themselves or not under the direct supervision of health care professionals at the~     time of administration.~   "
247037|NCT00319488|"~     This study will determine the effectiveness of initiating a high-dose inhaled corticosteroid~     (ICS) or a leukotriene receptor antagonist (LTRA) in addition to an inhaled beta2-agonist~     (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms in increasing~     episode-free days among young children with recurrent severe wheezing.~   "
247039|NCT00319462|"~     Point A, the major critical point for dose specification of intracavitary brachytherapy, is~     defined as the crossing of uterine artery and ureter in treatment of cervical cancer.~     However, the currently advocated systems use hypothetical point A (HPA) to estimate the~     dosimetry of brachytherapy. This study is to localize anatomic point A (APA) of cervical~     cancer patients for reference of radiotherapy. We will use laparoscopic clipping technique to~     localize APA for cervical cancer patients during pelvic and paraaortic lymph node sampling.~     When these patients are receiving brachytherapy, orthogonal radiographs will be obtained~     after insertion of tandem and colpostats by using Henschke afterloading applicators.~   "
247040|NCT00319449|"~     This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe~     10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian~     population with primary hypercholesterolemia.~   "
247041|NCT00319436|"~     The primary goal of this Stage I therapy development study will be to manualize and test the~     preliminary efficacy of a parenting intervention for drug dependent mothers that aims to~     foster their ability to recognize children's emotional needs at different ages and their~     capacity to be emotionally available to their children.~   "
247042|NCT00319423|"~     Aims:~        1. Evaluate the effect of an exercise therapy program and patient education, versus patient~          education only, on hip function among patients with radiologically verified hip OA~        2. To identify biomechanical differences during gait, one-leg standing , and~          two-legged-raise analysis in patients with hip OA following either exercise therapy and~          patient education program, or a patient education program only.~      Main Hypothesis:~      Significant improved hip function (WOMAC) will be demonstrated in patients with hip~     osteoarthritis (OA) (radiographically verified hip OA) following a patient education program~     and a 12 week exercise therapy program, compared to those only going through a patient~     education program.~      Material and Methods:~      110 patients with radiographically verified hip OA will be included in the randomized~     controlled trial; they will be randomized into:~        1. Patient Education, or~        2. Patient Education in addition to a supervised exercise program.~      The main outcome is:~      The Disease Specific WOMAC-Index.~      Secondary outcome measures are:~      SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, muscle strength~     tests, gait analysis (biomechanical analysis),6 minutes walking test, Åstrand's bike test,~     range of motion.~      Status:~      The PhD student is accepted at the University of Oslo,and the study has so far included 17~     subjects.~      The study will be carried out:~      NAR-Orthopedic Centre, Ullevaal University Hospital in collaboration with Diakonhjemmet~     Hospital and University of Delaware.~      The study is included in our research program for active rehabilitation.~   "
247043|NCT00319410|"~     This randomized clinical trial compares two methods of diagnostic hysteroscopy: vaginoscopic~     hysteroscopy vs. traditional method. Pain intensity was estimated using a visual analogue~     scale (VAS), and patient satisfaction was evaluated. These endpoints were compared by~     treatment assignment. Vaginoscopic hysteroscopy was associated with significantly lower VAS~     scores, indicating reduced experience of pain in this treatment group; however, this was not~     associated with improved patient satisfaction.~   "
247044|NCT00319397|"~     The purpose of this study is to investigate the effects of age, exercise and cardiovascular~     disease on blood pressure.~   "
247045|NCT00319384|"~     This trial will look at the effectiveness and patient acceptance of ultrafiltration therapy~     in an outpatient setting.~      The purpose of this study is to determine if ambulatory patients who suffer from heart~     failure and hypervolemia can be safely and effectively treated in an outpatient infusion~     clinic. The results from this trial will be useful in planning a larger, randomized trial~     comparing usual care and ultrafiltration for this patient population in similar ambulatory~     settings.~   "
247046|NCT00319371|"~     We study the skin-temperature (skin temperature measurement on different skin regions) and~     circadian rest-activity cycles (wrist activity monitoring) of 40 women in their daily life.~      This project will provide further information at which circadian phase vasospasms occur in~     daily routine life (one week recordings). Special interest lays on the time before sleep. The~     attained results could be used to establish a therapy with few side effects for people with~     difficulties initiating sleep because of vasospasm.~   "
247047|NCT00319358|"~     Chronic pancreatitis is a progressive inflammatory disease of the pancreas that presents with~     abdominal pain and in late stages may cause diabetes and malnutrition. The pain may be~     incapacitating and may affect patients physically, mentally and socially. Pain due to chronic~     pancreatitis is difficult to treat. Oxidative stress and free radical mediated injury has~     been shown to cause pancreatic inflammation. It has been shown that patients with chronic~     pancreatitis are deficient in micronutrients and natural antioxidants such as b-carotene,~     vitamin E and C etc. Studies have suggested that antioxidant supplementation may help to~     combat pain in these patients. Antioxidant supplementation may decrease the oxidative stress~     and boost the antioxidant status, thereby resulting in pain relief. The investigators have~     planned to perform a trial to study the effect of antioxidant supplementation on pain relief~     in patients with chronic pancreatitis.~   "
247048|NCT00319345|"~     The purpose of this study is to compare the effect of bolus of either sodium-lactate or~     mannitol on the evolution of intracranial pressure (ICP) during intracranial hypertensive~     episodes (IHE)~   "
247049|NCT00319332|"~     This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic~     regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with~     relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. A total of 350 patients,~     approximately 175 patients per arm, will be enrolled at 30 to 40 sites in the United States.~   "
247050|NCT00319319|"~     The purpose of this study is to determine whether the nicotinic receptor antagonist~     mecamylamine hydrochloride (Inversine) can augment SSRI-refractory major depression symptoms,~     quality of life and cigarette smoking outcomes. A total of n=60 SSRI-refractory patients who~     are on stable doses of an SSRI are being recruited into this 8-week double-blind, randomized,~     placebo-controlled trial.~   "
247051|NCT00319306|"~     The purpose of this study is to determine whether patients with asthma are better able to~     manage and control their symptoms by using one inhaler daily that both prevents as well as~     treats the symptoms of an asthma exacerbation.~   "
247052|NCT00319293|"~     Insulin resistance is an important feature of the polycystic ovary syndrome,and patiens are~     successfully treated with the insulin sensitizing agent metformin. The insulin resistance of~     lean patients with the syndrome is debated. In this study, we will study the change in~     insulin resistance, metabolic and hormonal factors after 3 months of metformin treatment in~     lean PCOS women.~   "
247053|NCT00319280|"~     In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high~     tibial osteotomy is a good choice of treatment for the young and active patient.~      However it leaves an open gap which has to be filled with a bone substitute and requires~     stable fixation.~      Hitherto the golden standard has been autograft taken from iliac crest but there are~     donorsite related problems and limited amount available.~      Recently injectable and resorbable calciumphosphate-cements have been introduced and used~     with promising results in fractures of the distal radius, calcaneus and lateral tibial~     condyle.~      These new cements seem to be a good alternative to other bone substitutes providing high~     initial strength that might promote early mobilisation; it resorbs and promotes~     osteoconduction securing safe healing.~      The aim of the present study is to evaluate whether there is any difference in clinical~     outcome, correction, stability and healing in open-wedge osteotomies with three different~     bone substitutes: Autograft from iliac crest and the injectable calciumphosphate-cement~     Calcibon and as control a group with an empty gap.~      Osteosynthesis is performed with the Dynafix® system (EBI) The investigation is performed as~     a randomised prospective clinical trial including 45 patients with a planned 2 years~     follow-up period.~      Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and~     Lysholm score.~      Routine standing x-rays is performed. Stability is assessed with Roentgen~     Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional~     measuring of eventual loss of correction.~      This combined with urine and serum bone-healing markers gives a very precise picture of the~     healing in the bone-gap.~      To asses the cartilage of the knee MRI is performed and biochemical markers fore Collagen~     type II degradation are measured.~   "
247054|NCT00319267|"~     The aim of the study is to demonstrate that the exposure to bosentan in children with~     idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension,~     using a pediatric formulation, is similar to that in adults with PAH and to evaluate the~     tolerability and safety of a pediatric formulation of bosentan in this patient population.~   "
247055|NCT00319254|"~     The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the~     treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB,~     IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.~   "
247056|NCT00319241|"~     This study is a randomized trial of interventions to improve parent-child relationships of~     drug-dependent mothers.~   "
247057|NCT00319228|"~     To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in~     the treatment of subjects with congenital AT-III deficiency.~   "
247058|NCT00319215|"~     The primary purpose of this study is to investigate the effects of bedtime administration of~     a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road~     driving performance. In addition, the drugs' effects on balance are evaluated during the~     night, and the next morning residual effects on memory and psychomotor performance.~   "
247059|NCT00319202|"~     Hypothesis:~      The use of candesartan 16-32 mg/d for 6 months improves the carbohydrate metabolism, and~     decreases the plasmatic levels of adipocytokines and oxidative stress markers, in non~     diabetic, non hypertensive subjects with dysglycemia and abdominal obesity, and these effects~     are independent of the changes in arterial blood pressure.~      General Objectives:~      The objective is to study the impact of the treatment with candesartan in the carbohydrate~     metabolism and the plasmatic levels of adipocytokines and oxidative stress markers, in non~     diabetic, non hypertensive subjects with dysglycemia and abdominal obesity.~      Study Design:~      This is a randomized, double blind, cross-over, placebo-controlled, clinical trial to assess~     the effects of candesartan (up to 32 mg/d for 6 months), over the carbohydrate metabolism,~     plasma levels of adipocytokines and concentrations of oxidative stress markers in non~     diabetic, non hypertensive, dysglycemic and obese subjects from Colombia. The total duration~     of the study is 36 months.~      Population:~      One hundred non diabetic, dysglycemic and obese, subjects of both genders, over 18 years old,~     will be included. To be included subjects should have blood pressure values under 140/90 mmHg~     and should be receiving no antihypertensive medical treatment.~      Procedures:~      Subjects whom fulfill all selection criteria will be included in a run-in period of 15 days~     with placebo and hygiene-dietary measures (MHD) including educational, nutritional and~     exercise support. The patients that during this Run in phase have a compliance equal to or~     greater than 80% will be randomized to one of the two treatment groups (Group A receiving~     candesartan 16/32 mg/d for 6 months and then placebo for 6 months, or Group B receiving~     placebo during the first 6 months and then candesartan 16/32 mg/d during the last 6 months)~     in a 1:1 proportion by blocks of 4 subjects. Randomization will be performed by the~     AstraZeneca clinical department. Both groups will concurrently receive the standard treatment~     with MHD. Control visits will be programmed every month. Metabolic parameters, including~     C-reactive protein (CRP), interleukin-6 (IL-6), adiponectin, leptin, insulin, malonaldehyde~     and 8-isoprostanes, will be evaluated every 6 months (at the beginning and end of each~     treatment).~      Statistical Analysis:~      The analysis strategy will be performed by intention-to-treat. In a descriptive analysis, the~     averages and proportions will be obtained with their corresponding 95% confidence intervals~     for the clinically relevant variables during the baseline evaluation. In order to evaluate~     the differences between the groups, the Student's t test, Mann-Whitney and Fischer's exact~     tests will be used according to the nature of the study variables. Multiple lineal regression~     will be used with the purpose of comparing the treatment groups from baseline and its changes~     up to the 6th month of treatment.~      Ethical Aspects:~      The study will be conducted according to the Helsinki declaration, the good clinical~     practices guidelines and the Colombian legislation. Prior to entering the study, patients~     must sign a written informed consent that has been approved by the Institutional Ethics~     Committee of Fundación Cardiovascular de Colombia.~   "
247060|NCT00319189|"~     The objective of the present study is to evaluate both the efficacy and safet of nateglinide~     in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose~     tolerance. Primarily will the change in glucose tolerance and acute insuline responce be~     addressed.~   "
247061|NCT00319176|"~     Venous thromboembolism is a condition that causes formation of blood clots in the body. It~     may have life threatening consequences if the leg veins, lungs or the brain blood vessels are~     involved. In pregnancy, a woman's baseline risk for forming blood clots is increased.~      Women with a known prior blood clot during pregnancy, artificial heart valves or other~     genetic conditions are at a very high risk for these complications during their pregnancy. It~     has been well established that these women benefit from medical treatment with a blood~     thinning medication in their pregnancies to prevent further formation of blood clots. These~     medications are called Heparins and are given as shots. Prior studies have suggested that a~     type of Heparin called low molecular weight heparin (Enoxaparin=Lovenox®) is well suited~     for use in pregnancy as it does not affect the baby and has a very low complication rate.~      The standard dose given for treatment of these patients has been established previously.~     However, there is a concern that complications may occur if the concentration of this~     medication falls below its effective level. It is of particular importance in pregnancy, as~     the rate of breakdown of this medication increases in pregnancy and may lead to lowering of~     its effective levels.~      Our study will evaluate the blood levels of enoxaparin before and after administration of~     this medication in pregnant women who are receiving this drug for treatment. This will~     determine whether an increase in the dose or an increase in the frequency of dosing might~     further improve the standard of care.~   "
247062|NCT00319163|"~     Primary Objective: To determine the bioequivalence between the clinical batch process and the~     new processes for manufacturing LNG/EE.~      Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in~     healthy, cycling women.~   "
247063|NCT00319150|"~     A strategy for optimizing erythropoietin therapy in patients with erythropoietin resistance.~     A multi-centered, open-label, randomized, controlled trial.~   "
247064|NCT00319137|"~     Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric~     oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of~     NOS, and therefore NO, may be an effective technique for the treatment of migraine headache.~     GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory~     activity in migraine through a novel mechanism of action. The intent of this study is to~     investigate the safety and efficacy of GW274150 for the acute treatment of migraine headache.~   "
247076|NCT00318981|"~     This study involves a 7 week dose-response trial of Concerta™ methylphenidate for mothers of~     children with ADHD who have ADHD themselves. The aim of this study is to assess the efficacy~     of Concerta™ in improving adult ADHD symptoms and impairments (primary outcome), as well as~     observed and reported parenting (secondary outcome). The researchers hypothesize that~     Concerta™ will significantly decrease mothers ADHD symptoms and impairment, as well as~     improve observed and reported parenting~   "
247077|NCT00318968|"~     The primary purpose of the study is to develop, and test, an algorithm for identification of~     responders to empirical esomeprazole treatment in general practices.~   "
247078|NCT00318955|"~     The purpose of this study is to assess efficacy and safety of dexmedetomidine at the time of~     extubation and after extubation, in patients requiring postoperative sedation in the ICU.~   "
247065|NCT00319124|"~     To identify differences between patients with OA of the hip in an early stage and a healthy~     control group.~      Hypothesis 1.1 There are significant differences between patients with OA of the hip in an~     early stage and a healthy control group in terms of functional capacity, biomechanical /~     kinematic variables, muscle strength and range of motion.~      Osteoarthritis (OA) is by far the most prevalent joint disorder today. The knee and the hip~     are large joints to be targeted and is an important cause of pain and disability. In knee OA,~     it is shown that significant risk factors in developing the disease are quadriceps weakness,~     joint instability, and changes in joint loading. A few studies on hip OA have shown altered~     gait pattern, which affect joint loading, and one study has shown weakness in abductors,~     adductors and flexors around the hip. As joint loading and muscle weakness are important~     factors in the development in knee OA, it might as well be factors influencing OA in the hip.~     The purpose of this case-control studies was to compare hip OA patients to a healthy control~     group regarding biomechanical and clinical differences. Patients with hip pain, activity~     limitations (Harris Hip Score 60-95 p) and radiographically verified hip OA was included. The~     healthy control group will have a Harris Hip Score of 100 p. One hundred and ten patients and~     fifty controls will be asked to fill in questionnaires on pain, stiffness and physical~     function (WOMAC), quality-of-life (SF-36 v2), self-efficacy (Lorigue), and activity (PASE) in~     addition to perform 6-minute walk test, sub-maximal cardiovascular function, strength, and~     hip range of motion tests. Additionally, Qualisys Pro reflex 3D motion analysis system will~     be used during walking, one-leg standing, and raising from a chair on a sub-group of 40~     patients and 20 controls.~   "
247066|NCT00319111|"~     The present trial investigates the long-term safety, tolerability and efficacy of bosentan in~     patients with inoperable CTEPH.~   "
247067|NCT00319098|"~     Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian~     virus. Prevention and control will depend on the rapid production and worldwide distribution~     of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and~     tested in clinical trials to determine the most optimal formulation and the best vaccination~     schedule. This study is designed to test in healthy adults aged above 18 years the~     reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1~     vaccine formulated from Split Virus.~   "
247068|NCT00319085|"~     Background~        -  Recently published studies confirm that preheating of femoral component enhances shear~          strength of implant-cement interface. Both Iesaka et al 2003 and Jafri et al 2004 showed~          reduction in cement porosity on cement-implant interface with preheated femur~          components. We will use the radiostereometry analysis (RSA) to investigate how the~          preheating of femur component influence on prosthesis survivorship. There are no~          clinical controlled studies performed to the date.~      The aim of the study~        -  Comparison of the migration rates between preheated and non-preheated femur components,~          analyzed with RSA.~      Methods~        -  Randomization of 80 patients into 2 groups with 40 in each. All patients will undergo~          standard hybrid total hip replacement. In group one the femur component (Bi-Metric,~          Interlock Biomet) will be preheated to 40 degrees of Celsius before cementation. In~          group two: the control group, the femur component will be of room temperature. We will~          measure the temperature at cement bone interface during the operation with use of~          thermocouple electrodes inserted through separate drill hole in the femur. The~          measurements will be recorded every 10 seconds. The patients will follow the standard~          postoperative rehabilitation program.~        -  The RSA analysis will be performed the first day after the operation and at 3, 12, 24~          months postoperatively.~        -  The Dual-energy X-ray absorptiometry scanning (DEXA) of the femur will be performed at~          the first week after the operation and at 12 and 24 months postoperatively.~        -  The patients will be followed both clinically and radiologically at 1 and 2 years after~          the operation (Harris Hip Score).~        -  The results will be expressed as mean + SD (in mm). ANOVA statistical analysis will be~          used to confirm the differences between the groups.~   "
247069|NCT00319072|"~     The purpose of this study is to evaluate a prototype web-based module for patients to~     generate appropriate and focused health information along with a customized set of questions~     to take to their health care provider for discussion on hormone replacement therapy.~   "
247070|NCT00319059|"~     Previous epidemiological studies have shown that in cardiovascular patients, the 34C>T~     variant in the gene encoding for the enzyme Adenosine Mono Phosphate Deaminase (AMPD1) is~     associated with prolonged survival.~      The 34 C>T variant encodes a severely truncated, metabolically inactive protein. We~     hypothesize that during ischemia, in these patients AMP in preferentially converted into~     adenosine instead of IMP. Adenosine receptor stimulation, in turn, will increase resistance~     to ischemia-reperfusion in the myocardial tissue.~      To test this hypothesis, 7 male healthy volunteers heterozygous for the 34C>T variant will be~     selected from 100 healthy volunteers, which we have previously genotyped. These subjects will~     be compared with 7 matched control subjects. Individual ischemic tolerance will be assessed~     in the thenar muscle using 99mTc-Annexin A5 scintigraphy.~      Briefly, the circulation of the nondominant forearm will be interrupted for 10 minutes by~     inflation of an upperarm cuff to 200mmHg en concomitantly, the subjects will perform~     isometric rhythmic handgripping until exhaustion. Immediately upon reperfusion, 400 MBq of~     99mTc-Annexin A5 will be administered intravenously. Finally, 1 and 4 hours post-injection,~     scintigrapghi imaging of both hand will be performed. Targeting of annexin A5 will be~     expressed as percentage difference between the experimental and control hand.~   "
247071|NCT00319046|"~     Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher~     disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are~     required to establish the long term efficacy, safety and tolerability of miglustat in~     maintaining diseases stability after a switch from ERT.~   "
247072|NCT00319033|"~     This study will asses the long term safety and efficacy of oral bosentan to patients~     suffering from Interstitial Lung Disease.~   "
247073|NCT00319020|"~     The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability~     of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial~     hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.~   "
247074|NCT00319007|"~     The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either~     combined or alone, are effective in treating or preventing adenoma development in the ileal~     anal pouch in patients with familial adenomatous polyposis.~   "
247075|NCT00318994|"~     To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis~     requiring surgery between 30 to 60 minutes after a bolus of 1 g IV meropenem given during the~     induction period of anesthesia.~   "
247122|NCT00318357|"~     The CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR)~     therapy on the mortality of patients from the CARE-HF program for an additional 4 year~     follow-up. Investigators are free to choose whatever available treatment they believe is in~     the patient's best interest.~   "
247079|NCT00318942|"~     Background: Two recent systematic reviews of the literature and meta-analyses have suggested~     that colloids administration might be deleterious in critically ill patients.~      Objective: To compare the effects on hospital mortality of crystalloids and colloids when~     given for fluid resuscitation in critically ill patients.~      Setting: Adult intensive care units (ICUs) in several European countries.~      Study design: A multinational, randomised, controlled trial performed on two parallel groups.~      Intervention: Any type of crystalloids (control group) versus any type of colloids (including~     albumin).~      Patients: All patients above the legal age of consent and hospitalised in an intensive care~     unit, who need fluid resuscitation (according to the physician). Pregnant women, moribund~     patients, brain dead patients, and patients who have a known allergy to colloids or severe~     head injury or major burns (> 20% of body surface) or dehydration will not be included.~      Primary endpoint: 28-day mortality.~      Hypothesis: Assuming a hospital mortality rate of 20% in the crystalloids group, a 0.05 type~     I error, 3010 patients are needed to show a difference between the 2 groups of 5% with a 90%~     probability (two-sided test).~   "
247080|NCT00318929|"~     There is a bimodal distribution to the new onset seizures with one peak occurring in the very~     young and the second peak occurring in persons over age 65 years. The presentation of~     seizures in the elderly may vary from that of younger patients and the diagnosis may be~     confused with other conditions such as transient ischemic attacks. However, the consequences~     of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and~     a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic~     and pharmacodynamic changes occurring in the elderly.~   "
247081|NCT00318903|"~     There is a need for more effective therapy for patients following surgery for esophageal~     carcinoma. Docetaxel and Irinotecan, independent of each other, have demonstrated activity in~     this disease. There is interest in the combination of these two active agents plus~     radiotherapy.~   "
247082|NCT00318890|"~     This trial seeks to accomplish both local and regional control of head and neck cancer and~     reduce systemic metastatic disease. To do this, patients will received chemotherapy followed~     by chemotherapy and radiation (given together) with an escalating dose of docetaxel.~   "
247083|NCT00318877|"~     The purpose of this study is to learn whether overweight children who participate in an after~     school team sports program improve their health as much as overweight children in a more~     traditional health education program.~   "
247084|NCT00318864|"~     The purpose of this study is to determine if improvements in mood will ameliorate autonomic~     dysregulation, HPA dysfunction and typical (e.g. lipids) and atypical risk factors in~     depressed patients with elevated cardiovascular risk (CVD). Up to 70, depressed participants~     with elevated cardiovascular risk factors were randomized to a cognitive behavioral~     intervention (CBT) or a waiting list control (WLC) condition. Twenty non-depressed age and~     risk-matched controls will also recruited. Traditional risk factors (e.g. lipids, blood~     pressure, heart rate), atypical risk factors (endothelial function, asymmetric~     dimethylarginine, C-reactive protein) will be measured pre and post treatment six months~     later Subjects will undergo a psychophysiological stress test while cardiovascular physiology~     was measured. Salivary cortisol will be measured during the day and during the psychological~     stress test. Depressed subjects will be randomized to a 16 week cognitive behavior therapy~     intervention or to a wait-list control. It is hypothesized that reduction in mood will be~     associated with reduction in typical and atypical risk factors.~   "
247085|NCT00318851|"~     The purpose of this study is to evaluate ischemic events and neuropsychological changes after~     carotid artery angioplasty and stenting with a neuroprotection device.~   "
247086|NCT00318838|"~     This study will assess the effect of multiple dosing of 125 mg azimilide on glomerular~     filtration rate (GFR) and total creatinine clearance (GFR + active secretion) in healthy~     subjects. Also, it will assess the effect of multiple dosing of 125 mg azimilide on renal~     hemodynamics (RPF) in healthy subjects.~   "
247087|NCT00318825|"~     The purpose of the study is to determine the analgetic effect of nitrous oxide during~     colonoscopy, compared to no sedation and intravenous (IV) sedation.~   "
247088|NCT00318812|"~     The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as~     intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with~     chronic kidney disease.~   "
247089|NCT00318799|"~     The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic~     parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover~     design.~   "
247090|NCT00318786|"~     This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of~     three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2~     diabetes.~   "
247091|NCT00318773|"~     Serotonergic antidepressants are clearly effective for premenstrual syndrome (PMS). This~     study compares short-term treatment (4 months) and long-term treatment (12 months) with~     sertraline to determine how long medication should be continued after achieving a good~     response, how soon symptoms return after stopping medication, and whether symptoms are~     further improved with long-term treatment. Multiple hypotheses include the following: The~     percent of relapsed subjects is greater with short-term treatment; relapse is swifter with~     short-term treatment; relapsed subjects improve swiftly when returned to medication; patient~     satisfactions and quality of life are more improved with long-term treatment.~   "
247103|NCT00318617|"~     The purpose of this study is to determine the effect of a 4-week treatment period with~     GW501516X on how the heart obtains and uses energy. The energy of the heart will be measured~     by Magnetic Resonance Imaging (MRI). This study will also measure a number of other potential~     markers of drug activity, including levels of certain lipids (fats) and proteins in your~     blood. The data from this study may help researchers better understand the actions of this~     drug in the body and if this drug may be useful to treat patients with heart disease.~   "
247104|NCT00318604|"~     This study investigates whether the amount of circulating plasma DNA can be used as a~     response marker for anti-cancer treatment in treating gross tumors.~   "
247105|NCT00318591|"~     The purpose of this study is to investigate the frequency of urinary tract infections with~     symptoms in spinal cord injured patients requiring intermittent catheterization for emptying~     the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.~   "
247092|NCT00318760|"~     Background:~      - Research has shown that clonidine, a drug originally prescribed to treat high blood~     pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse to~     heroin and cocaine seeking in rats. However, it does not seem to block cue-induced relapse in~     rats. Researchers are interested in studying whether clonidine shows the same pattern of~     effects on stress- and cue-induced cravings for heroin or cocaine in humans.~      Objectives:~      - To compare the ability of clonidine to reduce stress- and cue-induced cocaine and heroin~     craving in drug abusers.~      Eligibility:~      - Individuals between 18 and 55 years of age who are current cocaine or heroin users.~      Design:~        -  This study will consist of two visits: a screening visit to determine eligibility and an~          experimental/script session.~        -  Before the script session, participants will provide urine and breath samples for~          testing. Participants will complete questionnaires to measure their current drug craving~          and days since last use of cocaine or heroin.~        -  At the start of the script session, participants will receive a dose of clonidine or~          placebo as directed by the study researchers. Three hours after dosing, participants~          will be read four scripts (two neutral, one stress-inducing, and one drug-cue-related)~          with breaks in between each script. After each script, participants will respond to~          questions about levels of stress and craving.~        -  Participants will provide saliva samples immediately before and during the script~          readings, and will also be measured for skin response to the scripts.~   "
247093|NCT00318747|"~     This study will test the effectiveness of an investigational treatment for patients with~     ragweed-induced asthma, sometimes called fall seasonal asthma. The treatment being tested is~     a series of anti-ragweed shots. The purpose of the study is to determine whether a short~     series of injections with Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)~     can cause a long-lasting reduction in the symptoms of asthma that are caused by fall hay~     fever allergies.~   "
247094|NCT00318734|"~     Cardiovascular disease (CVD) affects millions of people in the United States; each year, more~     people die from CVD than from any other disease. There are many dietary and lifestyle factors~     that may increase the risk of developing CVD. Preliminary research has shown that the~     presence of certain trace elements may be associated with the development of CVD. This study~     will examine toenail clippings and laboratory data to evaluate the link between trace~     elements and CVD risk factors in young adults.~   "
247095|NCT00318721|"~     A cluster-randomized vector control trial in Bihar, India, and neighboring Nepal, will test~     the efficacy of long-lasting impregnated bednets (LLINs, Permanets) for reducing visceral~     leishmaniasis incidence. The intervention unit is the village (400-1000 people). The study is~     designed to detect a 50% reduction in Leishmania donovani incidence in intervention compared~     to control clusters over 2 years. 24 clusters (selected as high incidence during previous~     years) will be randomly allocated to intervention or control. Following health education, and~     with informed consent, all households in intervention villages will receive free Permanets~     (from September 2006). Net usage will be monitored and new nets provided if required. Control~     villages will not be given untreated nets, as - although commonly used in this region - their~     effectiveness against sandflies has not been proven. Pre-intervention infection status of~     villagers (>2 yrs) will be evaluated serologically from finger-prick blood (and past/current~     disease status noted). Incident infections will be recorded by 3-monthly active search for~     clinical cases, and by annual serological diagnoses to detect subclinical infections. All~     villagers (>2yrs) will be leishmanin skin tested at the end of the trial for further~     subclinical infection detection, and sera from a sub-sample will be tested for antibodies to~     sandfly saliva antigens (a measure of sandfly exposure). All clinical cases will be given~     free treatment. Free Permanets will be provided to control villages after the trial.~     Complementary studies involve entomological surveillance by light traps in a sample of houses~     and social/economic questionnaire surveys. The entomological surveys will test whether~     community-wide use of LLINs provides any mass effect, which could protect those in the~     community who fail to use LLIN for any reason.~   "
247096|NCT00318708|"~     Asthma can be caused by a variety of factors, including tobacco smoke, allergens, and~     respiratory airway infections. Many people use inhaled corticosteroid medications to treat~     their symptoms. These medications, however, are not effective for everyone. Clarithromycin is~     an antibiotic that may effectively treat asthma in these individuals. This study will~     evaluate the effectiveness of clarithromycin at controlling asthma symptoms.~   "
247097|NCT00318695|"~     This will be a double-blind, randomized placebo-controlled study. 253 children were recruited~     and randomly assigned into one of 2 groups to receive either normal infant formula or formula~     with Bifidobacterium longum and Lactobacillus rhamnosus GG. The primary aim is to assess the~     effect of early administration (from birth) of probiotics on the incidence of allergic~     sensitization, eczema, asthma and rhinitis.~   "
247098|NCT00318682|"~     A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The~     objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together~     with non-invasive techniques, and to determine how it is able to predict the histological~     fibrosis score, defined by the METAVIR score. This transversal study aims to compare the~     evaluation of hepatic fibrosis obtained by FIBROSCAN and histology (METAVIR score) in 2550~     consecutive patients taken in charge for a liver biopsy. The results of the study will~     compare the respective performances of these techniques in the prediction of the METAVIR~     score, and help in the recommendation of the care of patients with viral hepatitis B and C;~     these methods will undergo a medico-economic study.~   "
247099|NCT00318669|"~     This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).~   "
247100|NCT00318656|"~     A better glycemic control is associated with less complications (cardiac diseases, blindness,~     etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead~     to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than~     with a sulphonylurea (glimepiride).~   "
247101|NCT00318643|"~     The purpose of this study is to explore other treatments for patients with superficial~     bladder cancer. The investigational medication to be studied is an enzyme called~     hyaluronidase, and it is a human recombinant form of the enzyme. An investigational~     medication is a medication or formulation of a medication that is not approved by the United~     States Food and Drug Administration for use in this country but it may be used in studies~     such as this one. The drug company name for this medication is Chemophase. Chemophase will be~     given in combination with mitomycin C. Mitomycin C will be given alone one time and then both~     drugs will be given together weekly for 5 weeks. Mitomycin C is an anti-tumor drug that is~     commonly used to treat superficial bladder cancer. Treatments are administered directly into~     the bladder. It is envisioned that Chemophase with mitomycin C may potentially increase the~     local penetration of mitomycin C into remaining cancer cells following surgery to treat~     superficial bladder cancer.~   "
247102|NCT00318630|"~     This study is to investigate the effects of AVANDIA on the asthmatic response.~   "
247109|NCT00318539|"~     Quetiapine (Seroquel ®), an atypical antipsychotic registered for use in schizophrenia, which~     has a very low propensity of extrapyramidal and endocrine side-effects, has also been studied~     as an adjunct in OCD. In an open trial, ten patients with OCD who had not responded to at~     least three previous treatments with a SRI at maximum dose and duration were assigned to~     receive quetiapine in addition to a SRI for 8 weeks. Given the efficacy of quetiapine in~     treatment resistant patients, and given its rapid onset of action (4-6 weeks), it is~     postulated that the combination of a low dose atypical antipsychotic and a standard dosage of~     an SRI as a treatment for patients with OCD might increase the number of responders as well~     as the effect size.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
247110|NCT00318513|"~     The purpose of this study is to determine the safety and side effects of bevacizumab in~     subjects with lymphedema who will initially receive bevacizumab alone and then in combination~     with standard manual lymphatic drainage (MLD) and combined decongestive therapy (CDT). This~     study will help to determine the dose of bevacizumab to be used in future studies of subjects~     with lymphedema.~   "
247111|NCT00318500|"~     The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75~     mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms~     (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.~   "
247112|NCT00318487|"~     Fifteen (15) patients completely edentulous in the maxilla will be treated with 8 dental~     implants. The total treatment will be done in 2 stages to allow, within the same group, a~     study of two different approaches. Miniscrews that can be functionally loaded will be~     provided by 3i with the design and surface textures as wanted by the study sponsor.~   "
247113|NCT00318474|"~     IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of~     individuals diagnosed with IgAN, including children, will eventually progress to chronic~     renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the~     safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to~     be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements~     (FOS).~   "
247114|NCT00318461|"~     This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is~     designed to show the effect of treatment with liraglutide when adding to existing metformin~     therapy and to compare it with the effects of metformin monotherapy and combination therapy~     of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised,~     double-blinded period followed by an 18 months open-label extension, in total 2 years (104~     weeks).~   "
247115|NCT00318448|"~     There has been an increased interest in the association between ADHD and sleep disorders over~     the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been~     identified in ADHD children regardless of whether or not they are receiving stimulant~     therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD~     associated insomnia.~   "
247116|NCT00318435|"~     The type of hemodialysis access and preservation of this access greatly influences the~     quality of life and survival of patients undergoing hemodialysis. The Kidney Disease Outcomes~     Quality Initiative (K/DOQI) guidelines for vascular access recommend the primary placement of~     native or autogenous hemodialysis fistulas in preference to polytetrafluoroethylene (PTFE)~     grafts and central venous catheters because the former form of access has fewer complications~     and a longer durability. However, autogenous hemodialysis fistulas, like~     polytetrafluoroethylene grafts, are also subject to dysfunction and eventual failure.~     Endovascular angioplasty has become an accepted alternative treatment to surgical revision~     for hemodialysis access-related venous stenoses and occlusions. However, the patency rates in~     the follow-up period are low because of the high frequency of restenosis due to intimal~     hyperplasia. Since 1988, noncovered stents have been used to improve fistula patency. In the~     central veins, bare stents demonstrate better patency rates than percutaneous transluminal~     angioplasty (PTA) alone. Neointimal hyperplasia is the major reason for restenosis following~     stent placement. The cephalic vein forms the outflow conduit for radiocephalic and~     brachiocephalic autogenous fistulas. It has recently been suggested that a focal area of the~     cephalic vein is prone to developing hemodynamically significant stenosis, in what is now~     termed the cephalic arch. This is the perpendicular portion of the cephalic vein in the~     region of the deltopectoral groove before its junction with the axillary vein. To overcome~     the problem of restenosis due to intimal hyperplasia in the cephalic arch the investigators~     used the insertion of a stent-graft as an alternative approach. In this study they~     investigated the use of a PTFE-covered nitinol stent-graft (Fluency, Bard) versus a Luminex~     (Bard) stent.~   "
247117|NCT00318422|"~     This trial is conducted globally (the United States of America excepted). This trial is~     designed to show the effect of treatment with liraglutide when added to existing glimepiride~     therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on~     therapy to glimepiride.~   "
247118|NCT00318409|"~     Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual~     behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or~     acquiring HIV. No studies have tested the feasibility and acceptability of conducting~     pharmacologic interventions to reduce meth use and meth-associated sexual risk behavior among~     MSM. The purpose of this pilot study is to determine the feasibility enrolling and retaining~     meth-dependent MSM into a pharmacologic study of bupropion vs. placebo and measuring the~     tolerability of and adherence to medication among these participants.~   "
247119|NCT00318396|"~     This is a prospective, randomized study comparing two different bone preparation techniques~     for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who~     receive a unilateral total hip replacement are randomized to either conventional broaching or~     compaction.~      Hypothesis: Compaction results in significantly less stem migration [evaluated by~     radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss~     [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after~     two years.~   "
247120|NCT00318383|"~     The purpose of this study is to determine whether vaccination with NicVAX will result in a~     higher continuous abstinence rate than vaccination with placebo in smokers who want to quit~     smoking. In addition, two different formulations and dosing schedules will be studied, to~     select the dose and dosing schedule which generates the highest level of anti-nicotine~     antibodies. The primary study period is 12 months, which was extended by amendment to include~     up to 2 years of observations.~   "
247121|NCT00318370|"~     The purpose of this study is to determine if an investigational drug called MORAb-003 is~     useful by itself or when used with other approved cancer drugs in treating women with ovarian~     cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian~     cancers.~   "
247137|NCT00318162|"~     This study will examine the effects of low-dose naltrexone (LDN) on children with autistic~     spectrum disorders. The investigators hope to show a positive effect on social functioning~     and language.~   "
247123|NCT00318344|"~     For thousands of years people in the South Pacific have used Atuna racemosa extract as a~     topical anti-inflammatory. We, the researchers at the Mayo Clinic, have shown this extract to~     also have antibacterial properties. While this extract has been used for decades in the South~     Pacific, a controlled clinical trial to evaluate toxicity has never been performed.~   "
247124|NCT00318331|"~     Glutamine is an amino acid which is rapidly depleted in critical illness. It is used as~     energy by cells that line the gut, vital for immune system function, and works as an~     anti-oxidant. Glutamine supplementation has been shown to improve outcomes in ICU patients.~     We hypothesize that critically ill patients given extra glutamine will have less of an~     inflammatory response and therefore better outcomes than patients not given extra glutamine.~     Our study randomizes patients to tube feeding with OR without extra glutamine to see if it~     affects patient outcomes as well as markers of inflammation.~   "
247125|NCT00318318|"~     The purpose of this study is to assess the immunological status of patients using Premarin.~     Premarin use is associated with an enhanced immune status, and possibly even some anti-cancer~     effect. The researchers will compare the use of Premarin with those not using hormone~     replacement therapy (HRT) to track the effects of Premarin in reducing the risk of infection~     and swelling.~   "
247126|NCT00318305|"~     The purpose of this study is to determine patient preference and acceptance of tablet sodium~     phosphate bowel preparation in patients who had polyethylene glycol (PEG) solution for their~     prior colonoscopy. This study will provide answers related to the patient preferences and~     their acceptance of this new method of bowel preparation.~   "
247127|NCT00318292|"~     Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a~     painful stimulus. This trial is examining the effects of a local anesthetic given at the~     point of innervation prior to performing a vaginal hysterectomy with suspension sutures.~   "
247128|NCT00318279|"~     To determine if practicing an aorto-saphenous vein anastomosis on a low-fidelity surgical~     simulator allows trainees to produce a higher quality anastomosis in a shorter period of~     time, than a group that only learns by watching a video.~   "
247129|NCT00318266|"~     It is hypothesized that the NMP22(Nuclear Matrix Protein) Bladder Check ® Test will~     demonstrate improved sensitivity over that of standard urine cytology for patients with~     superficial transitional cell carcinoma at high risk of recurrence.~   "
247130|NCT00318253|"~     The study is based on the hypothesis that consumption of cranberry juice products results in~     the production of metabolites in the urine that have anti-adhesive properties on bacteria. A~     crossover study using 12 healthy women will be given different cranberry products or water as~     a control and their urine will be analyzed for anti-adhesive effects and compared to the~     properties of the urine. Cranberry juice will also be evaluated for its effect on vaginal~     microflora.~   "
247131|NCT00318240|"~     This is a feasibility study to determine safety and the ability of HIFU (High Intensity~     Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local~     recurrence of prostate cancer following radiation treatment.~   "
247132|NCT00318227|"~     The purpose of this study is to determine whether a less restrictive strategy of red blood~     cell transfusion in elderly patients following coronary bypass surgery results in enhanced~     postoperative recovery as determined by quality of life assessment, exercise tolerance and~     clinical outcomes.~      Two postoperative transfusion strategies:~        1. Liberal - transfused when Hgb is <100g/L~        2. Restrictive - transfused when Hgb is <70g/L~   "
247133|NCT00318214|"~     This is a clinical research study of an experimental topical drug for the treatment of~     chronic, neuropathic, diabetic foot ulcers. The purpose of the study is to determine the~     safety of the experimental drug when applied to large, diabetic foot ulcers. The study will~     also determine if the experimental drug can safely promote healing of diabetic foot ulcers~     better than standard treatments currently available to doctors.~      Patients participating in the study may receive an active drug (MRE0094) or inactive drug~     (placebo). What treatment a patient will receive is determined by chance (like drawing a~     number from a hat). All patients will receive additional care for diabetic foot ulcers during~     the study.~      Participation in the study can be up to 4½ months.~   "
247134|NCT00318201|"~     We, the researchers at the Indiana University School of Medicine, are doing this study to~     better understand how the effects of certain medications are altered when taken~     simultaneously, or in combination with each other. We will also look at how each volunteer's~     genes (DNA) may affect the way these medications are metabolized.~      Hypothesis:~      We will test the hypothesis that the extent of drug-drug interaction caused by the~     combination of erythromycin and diltiazem is not predictable from the extent of interaction~     produced by each inhibitor alone. Specifically we will test the hypothesis that the~     combination of erythromycin and diltiazem will cause a greater decrease in midazolam~     intravenous and oral clearance than the sum of the decreases caused by each inhibitor alone.~   "
247135|NCT00318188|"~     Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen~     deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to~     disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly~     used for vascular involvement. To date, no pharmacological treatment have been shown to be~     effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is~     that rehabilitation could be an interesting non pharmacological treatment in order to~     decrease the handicap of SSc patients. Our objective is to evaluate the effect of a~     personalized standardized rehabilitation program on the quality of life of SSc patients in a~     multicentric randomized controlled trial. This trial will compare a personalized standardized~     rehabilitation program to the usual non pharmacological treatment. The primary outcome~     measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design~     will be used for this study.~   "
247136|NCT00318175|"~     Endothelin-1 is a potent vasoconstrictor and binds to two receptors, ET-A and ET-B, which are~     variable expressed on endothelial cells, smooth muscle cells, and fibroblasts. Furthermore,~     endothelin-1 has been found to be released in vitro by scleroderma fibroblasts and could~     contribute to the development of dermal fibrosis in systemic sclerosis. Bosentan is a dual~     receptor antagonist, that competes with the binding of endothelin-1 to both receptors and has~     already been approved for the treatment of pulmonary arterial hypertension in Europe, the US,~     and some other countries. The purpose of this study is to evaluate the effect of bosentan~     treatment on skin fibrosis and functionality in patients with systemic sclerosis.~   "
247138|NCT00318149|"~     As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy~     adults, probably as a result of immunosenescence, there is a desire to devise ways to~     increase the current vaccines efficacy for this target population. Adjuvants are known to~     boost immune responses, thus representing one way to increase the efficacy of the current~     GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is~     to evaluate the immunogenicity and the reactogenicity of a vaccination with four different~     adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For~     immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly~     aged 65 years and older will receive Fluarix™ and form the control groups of this trial.~   "
247139|NCT00318136|"~     This is an open-label, single-arm, multicenter pilot study to evaluate the safety and~     efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb~     with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell~     Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.~   "
247140|NCT00318123|"~     To evaluate the therapeutic equivalence between the two arms of treatment in virological and~     immunological response after 48 weeks and to evaluate the presence of side effects during the~     follow-up period.~   "
247141|NCT00318110|"~     The purpose of this study is to find out what effects (good and bad) a stem cell transplant~     from an unrelated donor will have for patients with kidney cancer that has spread to other~     parts of the body (metastasized).~   "
247142|NCT00318097|"~     McCune-Albright syndrome (MAS) is a syndrome caused by a genetic mutation that causes a~     specific protein in the body called a G protein to be constantly active. Children with~     McCune-Albright syndrome classically have early puberty, areas of increased skin~     pigmentation, and bone lesions resulting from the constant activity of the specific protein~     involved.~      Histamines are known to play a role in allergies and related allergic problems. The effects~     of histamines are controlled by the same G protein that is overly active in McCune-Albright~     syndrome. Thus, one could predict that patients with McCune-Albright may be at high risk for~     allergic problems. To date, no studies have documented any form of histamine excess or~     allergic difficulties in patients with McCune-Albright syndrome. However, the investigators~     have made the observation that a high percentage of their patients with MAS exhibit a range~     of allergic symptoms, from mild symptoms, to severe, life-threatening symptoms.~      The purpose of this study is to demonstrate increased histamine response by using a histamine~     skin test in patients with MAS. If increased reactions to histamines can be documented in MAS~     patients when compared to controls, severe and potentially life threatening allergic~     reactions in children with MAS could be anticipated and avoided.~   "
247143|NCT00318084|"~     The purpose of this study is to determine the diagnostic value of two week treatment with~     Nexium as a confirmatory test for patients with suspected reflux disease.~   "
247144|NCT00318071|"~     The primary objectives of the Multi MERCI trial were:~        -  to evaluate the addition of the Merci L5 Retriever~        -  additionally permit use of the Merci Retrieval System in the setting of persistent clot~          following IV t-PA treatment (use in the 0-8 hour window for patients ineligible for IV~          t-PA was also permitted)~   "
247145|NCT00318058|"~     As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy~     adults, probably as a result of immunosenescence, there is a desire to devise ways to~     increase the current vaccines efficacy for this target population. Adjuvants are known to~     boost immune responses, thus representing one way to increase the efficacy of the current~     GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is~     to evaluate the immunogenicity and the reactogenicity of a revaccination with the adjuvanted~     GlaxoSmithKline influenza vaccine administered intramuscularly about 1 year after~     administration of the first dose of vaccine. For immunogenicity and safety evaluations,~     subjects who have already received Fluarix™ during the preceeding year will receive a dose of~     commercial vaccine and will form the control group of this trial.~   "
247146|NCT00318045|"~     The aim of this study is to examine the relationship between optical blur from poor~     refractive corrections (glasses) of workers using computers and their productivity and~     comfort in the workplace. We believe that improving the visual status of subjects who use~     computers will have a beneficial effect on productivity and visual comfort.~   "
247147|NCT00318032|"~     Diabetes is a common chronic condition associated with the risk of heart disease, and eye and~     kidney damage. Many people are diagnosed with diabetes when they develop symptoms or~     complications, suggesting that the true onset of disease occurs years earlier. Early~     detection of diabetes may result in health benefits, but this is not proven. People of South~     Asian origin are at more risk of having diabetes and of getting the heart disease~     complications associated with it. The study aims to test whether screening for diabetes is~     feasible in a South Asian population and to measure the benefits of early detection and~     intensive treatment.~      Hypothesis: A program of screening and an intensive multi-factorial intervention for type 2~     diabetes is both feasible and cost effective within primary care.~   "
247148|NCT00318019|"~     In this study the food supplement OPC Factor will be tested to determine its effectiveness~     for increasing energy levels in healthy people aged 45-65 when compared to a placebo. All~     subjects will receive both active product and placebo at some time during the study. The~     study is nine weeks in duration. It involves three visits, taking an effervescent powder in~     water twice a day, and answering 24 multiple choice questions once a week. Subjects who~     complete the study can elect to receive a two month supply of the study product free of~     charge.~   "
247149|NCT00318006|"~     This study will compare nasal saline irrigation with nasal saline spray for the treatment of~     chronic nasal and sinus symptoms. Participants will complete a questionnaire regarding their~     nasal and sinus symptoms and will be randomly assigned to one of the treatment groups. Each~     participant will be instructed on how to perform daily nasal treatment.The subjects will~     complete follow-up surveys at regular intervals to assess any change in their nasal symptoms~     after starting nasal saline treatment. Participants may take their usual medications for~     sinus symptoms during their participation in the study.~   "
247196|NCT00317382|"~     Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult~     and traumatic lumbar punctures?~   "
247150|NCT00317993|"~     The purpose of this study is to investigate the effects of the two lipid -lowering drugs,~     ezetimibe and simvastatin, on lipid metabolism in humans. In specific, the study will~     investigate in blood cells whether the enzyme that controls cholesterol synthesis, HMG-CoA~     reductase, and the receptor that takes up cholesterol from the blood, the LDL receptor, are~     changed during treatment with the aforementioned drugs.~   "
247151|NCT00317980|"~     The purpose of this study is to determine whether low-dose pentavalent antimony is equally~     effective when compared to the standard-dose regimen in patients with cutaneous~     leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.~   "
247152|NCT00317967|"~     The purpose of this study is to determine if a drug called atorvastatin will reduce the size~     and stiffness of the muscle in the left ventricle of the heart.~   "
247153|NCT00317954|"~     The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and~     bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic~     patients with albuminuria despite recommended antihypertensive treatment.~   "
247154|NCT00317941|"~     The purpose of this study is to compare the injection site reaction and injection site pain~     after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different~     autoinjectors.~   "
247155|NCT00317928|"~     Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women~     with PCOS. Ovulation is restored and bleeding periods become regular.~      Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for~     6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6~     months. Measurements are performed before ech treatment period, every second month during~     treatment and after completing treatment.~   "
247156|NCT00317915|"~     The aim of this multicenter, doubleblind, randomized study was to investigate the~     renoprotective effect of irbesartan treatment in patients with type 2 diabetes and~     microalbuminuria (a precursor of diabetic kidney disease). 590 patients were randomized to a~     median 24 months of treatment with 300 mg irbesartan once daily, 150 mg irbesartan once daily~     or placebo. Time to development of overt nephropathy, defined by persistent proteinuria, was~     the primary outcome measure.~   "
247157|NCT00317902|"~     The objective of this study was to treat anemic (Hemoglobin (Hb) < 12 g/dL) HIV-infected~     subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of > 13 g/dL and then to~     assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained~     with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.~   "
247158|NCT00317889|"~     This is a prospective, randomized study comparing two different bone preparation techniques~     for insertion of a porous coated titanium cementless femoral stem. Patients receiving a~     bilateral total hip replacement are randomized to conventional broaching on one side and~     compaction on the other side.~      Hypothesis: Compaction results in significantly less stem migration [evaluated by~     radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss~     [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after~     two years.~   "
247159|NCT00317876|"~     RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone~     marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune~     system from rejecting the donor's bone marrow. The donated bone marrow stem cells may replace~     the patient's immune system and help destroy any remaining abnormal cells. Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving cyclosporine and methotrexate before or after transplant may stop this from~     happening.~      PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide in~     treating patients who are undergoing a donor bone marrow transplant for Fanconi's anemia.~   "
247160|NCT00317863|"~     Zink and bone strength~   "
247161|NCT00317850|"~     The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is~     to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic~     troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial~     design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with~     idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6~     month's duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory~     were enrolled.~   "
247162|NCT00317837|"~     Insertion of a hemiarthroplasty is a well established treatment for a dislocated medial hip~     fracture in elderly patients. The purpose of this study is to compare unipolar and bipolar~     hemiarthroplasty as a treatment for patients aged 70 years or above with a dislocated medial~     femoral neck fracture. The study is prospective and randomised, and will be based on~     questionnaires, clinical examinations, registration of complications and radiographic~     evaluation at follow up at 3 months, 1 and 3 years postoperatively.~   "
247163|NCT00317811|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Ascorbic acid may help melphalan work better by making cancer cells more sensitive~     to the drug. Giving bortezomib together with ascorbic acid and melphalan may kill more cancer~     cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with ascorbic~     acid and melphalan works in treating patients with newly diagnosed multiple myeloma.~   "
247164|NCT00317798|"~     RATIONALE: Biological therapies, such as antithymocyte globulin may stimulate the immune~     system in different ways and stop cancer cells from growing. Sirolimus may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. It may also prevent or~     reduce the side effects of antithymocyte globulin. Giving antithymocyte globulin together~     with sirolimus may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of antithymocyte~     globulin when given together with sirolimus in treating patients with relapsed multiple~     myeloma.~   "
247197|NCT00317369|"~     The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its~     optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination~     with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral~     dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.~   "
247165|NCT00317785|"~     RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a~     donor stem cell transplant helps stop the patient's immune system from rejecting the donor's~     stem cells and helps stop the growth of cancer or abnormal cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving~     immunosuppressive therapy before or after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving total-body irradiation together with~     cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for~     hematologic cancer and other diseases.~   "
247166|NCT00317772|"~     The purposes of this study are:~        1. To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD)~          weekly of topotecan in combination with standard dose gefitinib in patients with~          relapsed, platinum-resistant, ovarian, peritoneal or fallopian tube cancers that are~          epidermal growth factor receptor (EGF-R) positive (>/= 1+).~        2. To determine the response rate and response duration in this patient population treated~          with the maximum tolerated dose (MTD) of topotecan administered on a weekly schedule in~          combination with standard dose gefitinib, given by way of the mouth (PO) daily.~   "
247167|NCT00317759|"~     RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to~     stimulate the immune system and stop cancer cells from growing. Fludarabine may help the~     immune system kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular~     adoptive immunotherapy in treating patients who have metastatic melanoma.~   "
247168|NCT00317746|"~     With the improved prognosis of human immunodeficiency virus (HIV) infection, end stage liver~     disease due to hepatitis C (HCV) now represents a major cause of morbidity and mortality in~     people with HIV. Treatment for HCV has become increasingly important as a means of preventing~     the consequences of chronic HCV infection. Paradoxically, co-infected patients have low rates~     of treatment initiation and completion in large part because they have a high risk of~     developing neuropsychiatric symptoms while receiving PEG-interferon (PEG-IFN). There are a~     large number of co-infected individuals in Canada who could benefit from HCV therapy if~     tolerability could be improved. This trial will address whether prophylactic use of~     antidepressants in HIV-HCV infected patients initiating HCV therapy can prevent the~     development of neuropsychiatric side effects and thus permit more patients to receive full~     treatment for HCV.~   "
247169|NCT00317733|"~     The purpose of this study is to determine the safety and effectiveness of 110 mg ketoprofen~     in Transfersome applied to the skin twice daily as compared to placebo and oral celecoxib 200~     mg per day for the relief of signs and symptoms of osteoarthritis of the knee for a period of~     six weeks.~   "
247170|NCT00317720|"~     Primary Objectives:~        1. To identify the optimal dose and pharmacokinetics of RAD001 in combination with~          trastuzumab in a Phase I trial~        2. To determine the efficacy of RAD001 plus trastuzumab in HER-2-overexpressing patients~          with resistance to trastuzumab-based therapy for metastatic breast cancer in a Phase II~          trial.~             1. Trastuzumab resistance will be defined as the development of progressive disease~               after trastuzumab-based therapy for metastatic breast cancer. Patients who develop~               metastases while receiving adjuvant or neoadjuvant trastuzumab will be eligible.~             2. Efficacy would be measured by the rate of objective response plus stable disease~               lasting 6 months (complete response (CR) + partial response (PR) + stable disease~               SD).~      Secondary objectives:~        1. To determine the pharmacokinetics of RAD001 in combination with trastuzumab. In the~          phase II portion of the study, pharmacokinetic studies will be optional.~        2. To determine the nature and degree of toxicity of RAD001 in combination with trastuzumab~          in this cohort of patients~        3. To determine expression levels of total and phosphorylated mTOR and p70S6K-T389-P as~          well as relevant downstream signaling components (e.g., S6, 4E-BP1) in pre- and post-~          treatment tumor samples.~        4. To correlate biomarker expression with response to therapy.~   "
247171|NCT00317707|"~     In the everyday practice cardiovascular prevention in people at high risk is still~     unsatisfactory and treatments with documented efficacy are generally under-used.~      Polyunsaturated fatty acids of marine origin (n-3 PUFA) are the latest more promising~     strategy to improve prognosis in these patients.~      The Risk and Prevention study combines an epidemiological and an experimental approach in~     order to:~        1. Verify the possibility to optimise cardiovascular prevention in subjects at high risk by~          planning the intervention with patients and setting individual goals (outcome study)~        2. Evaluate the efficacy of a long term n-3 PUFA treatment in reducing the incidence of~          cardiovascular events, through a controlled, randomised, double blind clinical trial.~   "
247172|NCT00317694|"~     Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food,~     reducing the amount that the body can absorb.~      The purpose of this study it to look at how effective and safe Magnesium iron~     hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive~     hemodialysis.~   "
247173|NCT00317681|"~     The purpose of this study is to evaluate the efficacy of topical tacrolimus in different~     subtypes of cutaneous lupus erythematosus. As shown by several groups activated memory T~     lymphocytes play a key role in the pathogenesis of lupus erythematosus. Tacrolimus targets T~     lymphocytes and suppresses their activation by inhibiting the expression of cytokine genes,~     such as IL-2. Therefore, treatment of cutaneous lupus erythematosus with topical tacrolimus~     might result in an improvement of skin lesions in such patients.~   "
247174|NCT00317668|"~     The investigators will check the serum of epilepsy patients for antibodies against glutamate~     receptors and double stranded DNA. They will characterise the patients (by the kind of~     epilepsy, autoimmune disease comorbidity, and cognitive profile).~   "
247175|NCT00317655|"~     The main purpose of this study is to investigate the ability of some dietary supplement~     products to affect general joint health and life quality in a selected population with back~     pain.~      The study is randomized and double - blind, with parallel groups receiving treatment for a~     duration of 12 weeks.~   "
247255|NCT00316615|"~     The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular~     (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006,~     when Administered to Non-Elderly Adults and Elderly Subjects~   "
247176|NCT00317642|"~     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the~     treatment of pediatric patients 1 to 21 years old with relapsed acute or refractory~     lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.~      There is no recommended standard treatment for relapsed or refractory acute myelogenous~     leukemia in older patients. Cytarabine is the most commonly used drug to treat these~     patients. This study will determine if there is benefit by combining clofarabine with~     cytarabine. Patients will be randomized to receive up to 3 cycles of treatment with either~     placebo in combination with cytarabine or clofarabine in combination with cytarabine.~     Randomization was stratified by remission status following the first induction regimen (no~     remission [i.e., CR1 = refractory] or remission <6 months vs CR1 = remission ≥6 months). CR1~     is defined as remission after first pre-study induction regimen. The safety and tolerability~     of clofarabine in combination with cytarabine and cytarabine alone will be monitored~     throughout the study.~   "
247177|NCT00317629|"~     Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an~     increasing incidence over the last two decades. So far, pentavalent antimony compounds have~     been considered the treatment of choice, with a percentage of cure of about 85%. However, the~     high efficacy of these drugs is counteracted by their many disadvantages and adverse events.~     Previous studies have shown nitric oxide to be a potential alternative treatment when~     administered topically with no serious adverse events. However, due to the unstable nitric~     oxide release, the topical donors needed to be applied frequently, making the adherence to~     the treatment difficult. The electrospinning technique has allowed the production of a~     multilayer transdermal patch that produces a continuous and stable nitric oxide release. The~     main objective of this study is to evaluate this novel nitric oxide topical donor for the~     treatment of cutaneous leishmaniasis.~      A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620~     patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether~     this patch is as effective as meglumine antimoniate for the treatment of cutaneous~     leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous~     leishmaniasis will be medically evaluated and laboratory tests and parasitological~     confirmation performed. After checking the inclusion/exclusion criteria, the patients will be~     randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously~     meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo~     of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the~     medications will be administered daily and the presence of adverse events assessed. During~     the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The~     healing process of the ulcer, the health of the participants, recidivisms and/or reinfection~     will also be assessed. The evolution of the ulcers will be photographically registered. In~     the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic~     alternative for one of the most important public health problems in many countries will be~     available to patients.~   "
247178|NCT00317616|"~     Pre-fALS is a prospective natural history and biomarker study of people not yet affected with~     ALS, but who are at genetic risk for developing ALS. The investigators aim to recruit~     unaffected (healthy) people from familial ALS (fALS) pedigrees in which a known genetic~     mutation associated with ALS has been identified; for this study, a fALS pedigree is one with~     two biologically related individuals who have or have had ALS and/or FTD. Individuals who may~     be at genetic risk for ALS and who belong to families with at least one affected family~     member who has tested positive for a known ALS genetic mutation may also be eligible to~     participate. Our goal is to study the pre-symptomatic phase, onset and progression of ALS and~     to learn more about genetic and environmental factors that put people at risk for developing~     ALS.~   "
247179|NCT00317603|"~     The purpose of this trial is to test the safety of a vaccine made from a patient's own breast~     cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The~     vaccine is made by genetically modifying a patient's own tumor cells to secrete~     granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response.~   "
247180|NCT00317590|"~     There is increasing evidence from African countries, including Burkina Faso, that at least in~     some settings/seasons the proportion of fevers attributable to malaria is low or very low:~     this means that the current strategy of treating all fever cases as malaria is only to the~     advantage of very few. Rapid, antigenic tests might be of help, particularly in peripheral~     health centres such as the Centres de Santé et Promotion Sociale (CSPS) that lack any~     laboratory facilities. Nevertheless two major problems could arise:~        -  False negatives: as only the negative result would change the decision to treat, versus~          the current presumptive strategy, false negatives would not be treated for malaria.~        -  False positives: they would be exposed to the risk to be left without treatment for the~          true cause of their fever instead.~      The main purpose of this study is to assess if the short term outcome of febrile patients~     treated after testing with the Rapid Diagnostic Test Paracheck® is at least equivalent (not~     inferior) to that of controls (presumptively treated without any test) in terms of clearance~     of fever and other major symptoms and signs.~      To do so, febrile patients will be randomly assigned to be submitted to the test before~     clinical decision, or to be managed the usual way with no test. A follow up will be carried~     out at Day 4th in order to determine the proportion of patients in both groups with~     persistence of fever and other main clinical symptoms.~   "
247181|NCT00317577|"~     Low-pressure (normal tension) glaucoma is a type of open-angle glaucoma resulting in damage~     to the optic nerve and abnormalities of the visual field. Eye (intraocular) pressure in this~     type of glaucoma is not higher than that usually considered to be normal (less than 21 mmHg)~     for the eye. The present treatment of low-pressure glaucoma is also directed to lowering the~     “normal” eye pressure. Both medications in this study, brimonidine and timolol, lower eye~     pressure.~      Laboratory research over the past decade indicates the potential to treat glaucoma not only~     by lowering eye pressure, but with treatments aimed at the damage occurring at the optic~     nerve. One group of drugs, selective alpha2-adrenergic agonists, have been shown in~     laboratory animals to protect against the effects of nerve damage following local stroke.~     Brimonidine, one of the medications in the current study, is a selective alpha2-adrenergic~     agonist which protects against damage to optic nerve in animal models of glaucoma..~      The hypothesis of the present study is that brimonidine eye drops provide protection to the~     damaged optic nerve independent of lowering eye pressure in patients with low-pressure~     glaucoma. This will be determined by (1) measuring eye pressure, (2) performing visual field~     examinations, and (3) examination of the optic nerve.~   "
247198|NCT00317356|"~     The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and~     to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for~     8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients~     with active ulcerative colitis.~   "
247256|NCT00316602|"~     The purpose of this study is to compare the immunogenicity and safety of an investigational~     smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.~   "
247182|NCT00317564|"~     This is a prospective, observational, registration and follow-up study of women exposed to~     Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual~     period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine~     whether there is an increased risk or a pattern of birth defects in the offspring of women~     exposed to Betaseron® at conception and during pregnancy compared to rates from women in the~     general US population. Secondarily, the Registry will examine rates of spontaneous abortions~     and other negative pregnancy outcomes in this population. This study will be conducted in the~     United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare~     Pharmaceuticals and is managed by the Post Approval & Strategic Services group at INC~     Research, LLC. The scientific conduct and analysis of the Registry will be overseen by an~     Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in~     teratology, epidemiology, maternal and fetal medicine, and neurology (external member details~     available upon request).~   "
247183|NCT00317551|"~     We have identified focussing problems related to myopia getting worse. Our trial uses optical~     and orthoptic interventions that correct the focussing problems to see if this retards myopia~     progression.~   "
247184|NCT00317538|"~     The purpose of this study, in patients with rheumatoid arthritis who have had an incomplete~     response to etanercept and methotrexate (MTX), are to evaluate: safety and evidence of~     therapeutic benefit of infliximab and methotrexate, the levels (pharmacokinetics) of~     etanercept and infliximab and antibodies (immunogenicity) to etanercept and infliximab in~     patients blood, whether switching from etanercept to infliximab changes progression of~     structural damage over the study period, and whether specific markers in the blood~     (pharmacodynamics) correlate with therapeutic response or benefit.~   "
247185|NCT00317525|"~     The aim of this study is to examine the relationship between optical blur from poor~     refractive corrections (glasses) of older workers using computers and their productivity and~     comfort in the workplace. The investigators believe that improving the visual status of~     subjects who use computers will have a beneficial effect on productivity and visual comfort.~   "
247186|NCT00317512|"~     The purpose of this study is to assess the safety and feasibility of a novel oxygen carrying~     solution, HBOC-201, in the setting of PCI for Acute Coronary Syndromes from randomization til~     hospital discharge.~   "
247187|NCT00317499|"~     This was a phase 3, double-blind, placebo-controlled, randomized, multicenter study in~     subjects with psoriatic arthritis (PsA) and psoriasis comprising 3 periods: a 24-week~     double-blind period, a ≤ 24-week maintenance period, and a 48-week open-label period. During~     the double-blind period, subjects were randomized equally to 1 of 2 regimens: etanercept 25~     mg twice weekly (BIW) or placebo, administered subcutaneously (SC). After the week 24 visit,~     subjects continued on blind-labeled therapy in a maintenance period until all subjects~     completed the double-blind period. After the maintenance period, all subjects received~     open-label etanercept 25 mg BIW.~   "
247188|NCT00317486|"~     This study evaluates the effects of bosentan on oxygen saturation, hemodynamics and exercise~     capacity in patients with pulmonary arterial hypertension related to Eisenmenger physiology.~     Patients receive bosentan or placebo for 16 weeks.~   "
247189|NCT00317473|"~     To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed~     children living in western Kenya and aged 12-47 months~   "
247190|NCT00317460|"~     The purpose of this study is to examine the efficacy of providing two levels of psychosocial~     support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients~     receiving their care in an HIV clinical care setting.~   "
247191|NCT00317447|"~     Sciatica (lumbosacral radiculopathy) is a common diagnosis in primary care, occurring in~     approximately one percent of all patients with acute low back pain. (1, 2) Traditional~     treatment generally involves pain control (acetominophen, NSAID’s, or narcotics), activity as~     tolerated, and time. (1, 3-8 ) The general consensus is that fifty percent of patients with~     sciatica recover within six weeks, and that ninety percent are better in twelve weeks.(4, 8)~     Those patients with intractable pain or progressive neurologic symptoms usually receive~     epidural steroid injections and, if necessary, decompressive laminectomy or discectomy. (2,~     8, 9)~      Low back pain and sciatica result in tremendous losses to our society in terms of decreased~     productivity and cost of treatment. (1, 12) Oral steroids are inexpensive and relatively safe~     medications that, if effective in reducing the pain and disability associated with sciatica,~     could improve the quality of patients’ lives, and result in significant cost savings to~     society at large. We hypothesize that the use of oral steroids to treat acute sciatica will~     speed patients’ recovery as measured by: changes in physical findings, rates of return to~     work and activities of daily living, pain and disability assessment scores, and decreases in~     the use of narcotic and non-steroidal anti-inflammatory drugs (NSAID’s), and in the need for~     epidural injection or surgical intervention.~   "
247192|NCT00317434|"~     The purpose of this study is to determine the maximum tolerated dose of Lapatinib with~     Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal~     carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with~     carboplatin AUC 6 in this cohort of patients.~   "
247193|NCT00317421|"~     The purpose of the study is to investigate if regular treatment with sildenafil reduces blood~     pressure and improves blood vessel function in patients with hypertension (high blood~     pressure).~   "
247194|NCT00317408|"~     RATIONALE: Giving combination chemotherapy and total-body irradiation before a peripheral~     stem cell transplant that uses the patient's or a donor's stem cells, helps stop both the~     growth of cancer cells and the patient's immune system from rejecting the stem cells. When~     the stem cells are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy and~     total-body irradiation followed by a stem cell transplant may be an effective treatment for~     anaplastic large cell lymphoma.~      PURPOSE: This clinical trial is studying how well combination chemotherapy followed by stem~     cell transplant works in treating young patients with progressive or relapsed anaplastic~     large cell lymphoma.~   "
247195|NCT00317395|"~     Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5~     intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute~     coronary syndromes (ACS) and planned early invasive strategy.~      Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and~     pharmacodynamics (PD).~   "
247199|NCT00317343|"~     RIAPRE is a non-interventional registry to be settled in Italy with the purpose of collecting~     data on 600 cases of high risk elective percutaneous coronary intervention (PCI) patients~     treated with an anticoagulation regime different from unfractionated heparin in monotherapy.~     About thirty catheterization laboratories will co-operate in this activity. The long term~     outcome of patients will be taken into consideration. The availability of these data will~     allow for a better understanding of the therapeutic needs in this area.~   "
247200|NCT00317330|"~     This study will test the effectiveness of two different tuberculosis (TB) prevention~     strategies, DOTS or DOTS-A. DOTS is the current prevention strategy for TB. DOTS-A is an~     enhanced prevention strategy that will screen household members of individuals diagnosed with~     active TB and will provide enhanced treatment as needed. The study will be conducted in 8~     communities located in Rio de Janeiro. Study participants will include 6400 males and females~     of all ages, including active TB patients and their household contacts. Patients with TB~     identified for treatment at the Health Clinics of 8 urban communities will be eligible. The~     communities will be assigned to 1 of the 2 prevention strategies, DOTS or DOTS-A. After 4~     years, the information gathered during the study will be used to determine the incidence of~     TB in these communities to see which prevention strategy was more effective in decreasing TB.~   "
247201|NCT00317317|"~     Infertility is a common problem with increased incidence. In-vitro fertilization (IVF) is by~     far the most commonly used treatment. The success rate of IVF is still low. This study~     examines the effect of acupuncture on IVF pregnancy rate, as well as possible mechanisms. It~     is hypothesized that acupuncture can significantly increase the IVF pregnancy rate.~   "
247202|NCT00317304|"~     Stress appears to be related to hot flash frequency and intensity, and the degree of distress~     that women experience from their hot flashes appears to be related to their coping resources.~     This trial is a pilot study to test the effect of participation in a mindfulness-based stress~     reduction program on hot flash frequency and intensity, as well as menopause-related quality~     of life.~   "
247203|NCT00317291|"~     This is a sample-size-limited, randomized, blinded (subject and evaluator), sham~     acupuncture/placebo moxibustion (sham acu/placebo moxa) controlled clinical trial. The~     subjects in this study will be 50 men and women with HIV infection who have a diagnosis of~     distal symmetric peripheral neuropathy (DSP). Subjects will be randomized to one of two~     experimental intervention conditions:~        -  Condition 1: subjects receive acu/moxa treatment; and~        -  Condition 2 (Control Group): subjects receive sham acu/placebo moxa.~      All subjects in Conditions 1 and 2 will attend 16 scheduled sessions over 15 weeks, be~     administered the same instruments, and submit their daily symptom diaries for analysis. There~     will be six weeks of twice weekly treatment sessions, and three follow-up sessions at weeks~     9, 11, and 15. All conditions will be identical in duration and be administered by licensed~     acupuncturists trained in traditional Chinese medicine (TCM).~   "
247204|NCT00317278|"~     Infants in the Neonatal Intensive Care Unit (NICU) are exposed to stressful stimuli such as~     loud noises, bright lights, blood drawing, suctioning, and intubation, and are frequently~     left in isolation with minimal proper interaction. Stress has been demonstrated to exert a~     negative effect on the immune system. Different psychological interventions, including~     relaxation, have been used in efforts to reduce stress, and several of these techniques have~     been shown to improve cellular immunity. Massage therapy (MT) has been used to reduce stress~     in premature infants and has been associated with weight gain, shorter hospital stay, and~     improvement in mental/motor development. While MT has been shown to increase the number and~     function of natural killer (NK) cells in healthy adults and in adults infected with HIV, the~     effect of MT on the immune system of children, including premature infants, has never been~     investigated. The investigators hypothesize that, in premature infants, MT will enhance the~     immune system. One hundred and twenty stable premature infants meeting selection criteria~     will be randomized to massage and sham treatment groups. Immunologic evaluation will be~     performed on both groups at baseline, midway and at the end of therapy. Physicians, nurses,~     and parents will be masked. The investigators' unique and innovative study will be the~     largest study in this area and will provide valuable information on potential immune~     parameters associated with stress reduction and improved development in premature infants~     undergoing massage therapy.~   "
247205|NCT00317265|"~     This is a randomized, prospective European Multicenter Study comparing complete arterial~     revascularization of the coronary arteries using arterial graft material exclusively and~     “conventional” coronary artery bypass surgery using the left internal thoracic artery as~     graft to the left anterior descending artery (LAD) and vein grafts to other vessels to be~     bypassed.~   "
247206|NCT00317252|"~     The purpose of this study is to determine if patients should stop taking their angiotensin~     converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) around the time of~     their angiogram in order to prevent contrast induced nephropathy (CIN).~   "
247207|NCT00317239|"~     This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron~     (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with~     non-dialysis dependent chronic kidney disease (NDD-CKD).~   "
247208|NCT00317226|"~     The primary objective of this study is to evaluate the long term safety and tolerability of~     an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of~     non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension~     to protocol 1VIT04004 (NCT00317239).~   "
247209|NCT00317213|"~     It has been shown in rodent models that chronic substance abuse is associated with a~     rigidification of cell membrane fluidity due to a change in the membrane~     cholesterol/phospholipids ratio. Upon substance withdrawal the membrane undergoes~     reequilibration of this ratio, a process resulting both in an acute and a prolonged severe~     withdrawal syndrome. MBM has developed a patented,phosphatidic acid-enriched phospholipid~     platform (LIBERTAL), which is supposed to facilitate the membrane fluidity recovery. The~     company has focused on nicotine withdrawal in smoking cessation,as primary target.~   "
247227|NCT00316979|"~     Migraine is a condition thought to be related to cortical hyperexcitability. Repetitive~     transcranial magnetic stimulation (rTMS) can modulate the cortical excitability by means of~     long-term potentiation or long-term depression. This study will will test the safety and~     efficacy of rTMS in the treatment of patients with Migraine.~   "
247210|NCT00317200|"~     Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously~     tested and found to have significant single agent activity in relapsed SCLC, including in~     refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are~     associated with worse outcomes. Bevacizumab, a monoclonal antibody to VEGF, increase response~     rates and survival when combined with chemotherapy agents compared with the chemotherapy~     agent alone in NSCLC, breast cancer, and colorectal cancer. Paclitaxel plus bevacizumab, in~     the dose and schedule proposed in this study, improves response rates and progression free~     survival compared with paclitaxel alone in women with metastatic breast cancer. Therefore, we~     will be testing the safety, feasibility, and efficacy of this regimen in patients with~     chemosensitive relapsed SCLC.~   "
247211|NCT00317187|"~     The purpose of this study is to compare the reactogenicity & safety of~     Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care,~     Tritanrix™-HepB/Hiberix™.~   "
247212|NCT00317174|"~     The purpose of the study is as follows:~        -  To evaluate the persistence of antibodies and the presence of immune memory induced by a~          3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the~          study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC~          at 10 months age to one subset of subjects.~        -  To evaluate the persistence of all antibodies pertaining to primary vaccination and the~          booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine~          at 15-18 months age in the other subset of subjects.~   "
247213|NCT00317161|"~     The purpose of the study is to demonstrate consistent results in 3 production lots of~     Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a~     single injection, with respect to immunogenicity, safety and reactogenicity.~     Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine~     (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark~     vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.~   "
247214|NCT00317148|"~     The purpose of the study is to evaluate the effect of daily oral intake of DHEA 50 mg for 4~     months on reducing vasomotor symptoms (hot flashes) compared to placebo administration in~     postmenopausal women.~   "
247215|NCT00317135|"~     The purpose of this study is to compare the reactogenicity & safety of~     Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care,~     Tritanrix™-HepB/Hiberix™.~   "
247216|NCT00317122|"~     This study will only include infants born to mothers who are tested as seronegative for human~     immunodeficiency virus (HIV) & hepatitis B surface antigen (HBsAg). The purpose of this study~     is to demonstrate in infants who received a birth dose of hepatitis B vaccine that~     Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with~     respect to immunogenicity of the hepatitis B antigen.~   "
247217|NCT00317109|"~     The purpose of this study is to assess the safety and reactogenicity of a booster dose of~     diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b~     vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and~     reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal~     vaccine (ACW) at 24 to 30 m in primed subjects.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
247218|NCT00317096|"~     The aim of this phase III trial is to assess the safety and efficacy of treatment with~     rituximab in combination with FCM chemotherapy (R-FCM) versus FCM chemotherapy alone for~     remission induction and to asses the safety and efficacy of rituximab maintenance versus~     observation only after response to induction therapy. Both questions are addressed in way of~     a prospective randomized comparison in patients with relapsed FL, MCL and LP lymphoma.~   "
247219|NCT00317083|"~     Up to 70% of obese patients undergoing bariatric surgery have obstructive sleep apnea~     syndrome (OSAS). OSAS is responsible for laryngeal sensory impairment. As the afferent neural~     pathway involved in the initiation of cough is located in the laryngeal epithelium, cough~     reflex sensitivity may be decreased in obese OSAS patients. The researchers therefore~     conducted this study to determine the effect of OSAS associated with obesity on cough reflex~     sensitivity, assessed by cough reflex threshold to an inhaled irritant (citric acid).~   "
247220|NCT00317070|"~     The primary objective of this study is to evaluate the efficacy and tolerability of the~     intravesical cocktail and its comparison with intravesical DMSO in a controlled trial for the~     treatment of painful bladder syndrome including interstitial cystitis.~   "
247221|NCT00317057|"~     Patients admitted to the hospital with chronic obstructive pulmonary disease are evaluated~     with regard to early follow-up by a specialized nurse in the home after discharge.~   "
247222|NCT00317044|"~     The purpose of this study is to determine whether treatment with esomeprazole for 6 months~     will improve asthma in adult patients with moderate to severe asthma and symptoms of~     gastroesophageal reflux disease.~   "
247223|NCT00317031|"~     The primary objective is to directly compare the efficacy of acamprosate, naltrexone and~     placebo for relapse prevention in alcoholics.~   "
247224|NCT00317018|"~     Small contract VA Community Based Outpatient Clinics present unique challenges to~     implementation of collaborative care because of their distinct organizational characteristics~     and lack of on-site psychiatrists. A recent effectiveness study, successfully used~     telemedicine technologies to adapt the collaborative care model for small rural VA Community~     Based Outpatient Clinics. The purpose of the proposed study is to implement this~     telemedicine-based collaborative care model in small Contract VA Community Based Outpatient~     Clinics and determine its sustainability and cost-effectiveness.~   "
247225|NCT00317005|"~     Homocysteine recently gained access to the category of risk factor for the development of~     atherosclerotic cardiovascular disease in the general population. Chronic renal failure~     patients, even before being introduced to dialysis therapy have almost universal elevation of~     serum homocysteine; when on dialysis their mortality is above 50% related to cardiovascular~     disease that we might now speculate, with a contribution of potentially toxic levels of the~     aminoacid homocysteine.~   "
247226|NCT00316992|"~     The purpose of this study is to determine if ramelteon has respiratory depressant effects in~     subjects with moderate to severe chronic obstructive pulmonary disease.~   "
247228|NCT00316966|"~     With the introduction of the National Insurance Law in Israel in 1995, there have been~     increased efforts to reduce hospitalization in general and length of stay in the hospital in~     particular. Under nourished patients have been shown to have a longer mean length of stay and~     they are more likely to suffer from complications, which significantly increase cost of care.~     Intense nutritional intervention programs, aimed at decreasing rehospitalizations and post~     hospitalization complications, are not clearly currently included in the basket of services~     provided under the law. Nutritional intervention has been shown to be clinically efficacious~     and cost-effective. Demonstration of the benefits of such intervention, both in terms of~     reduced expenditures and quality of care, may open a path for specific nutritional~     intervention programs that are needed for older persons during and after discharge from Acute~     Care. Given the effort made to reduce the length of hospitalization time, even in frail~     elderly patients, it is clear that full scale nutritional intervention cannot be completed~     during their hospitalization. Therefore, there is a need to create continuity between~     in-patient and follow-up nutritional intervention. This combined policy has the potential to~     improve general health, reduce the rates of under nutrition and its associated complications,~     and thus reduce future hospitalization, along with the mortality and morbidity associated. It~     is plausible that improved general health and less frequent hospitalization will eventuate in~     cost reduction and allow the intervention to be cost effective. Furthermore, the descriptive~     information regarding the nutritional status of older patients admitted to an Acute Care~     department may be important for policy makers in their development of nutritional~     intervention programs to support the elderly before, during and after hospitalization.~      Study Hypothesis:~      We hypothesize that multidisciplinary nutritional intervention, during and following~     hospitalization, will improve dietary intake and nutritional status. Improvement in~     nutritional status will, in turn, cut health care costs by decreasing the use of health~     services. In-hospital nutritional care will be beneficial, but combined in-hospital and~     community care will be more clinically efficacious and more cost effective in the long run.~   "
247229|NCT00316953|"~     This phase I trial is studying the side effects and best dose of dasatinib in treating young~     patients with recurrent or refractory solid tumors or Philadelphia chromosome-positive acute~     lymphoblastic leukemia or chronic myelogenous leukemia that did not respond to imatinib~     mesylate. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth~   "
247230|NCT00316940|"~     RATIONALE: Radioactive substances, such as samarium 153, may release radiation as it breaks~     down and kill cancer cells. Bortezomib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Bortezomib may also make tumor cells more sensitive to~     radiation. Giving samarium 153 together with bortezomib may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of samarium 153 when~     given together with bortezomib in treating patients with relapsed or refractory multiple~     myeloma.~   "
247231|NCT00316927|"~     RATIONALE: Giving dexamethasone together with aspirin and diethylstilbestrol may be effective~     in lowering prostate-specific antigen levels and may slow or stop the growth of prostate~     cancer. It is not yet known which schedule of dexamethasone, aspirin, and diethylstilbestrol~     is more effective in treating prostate cancer.~      PURPOSE: This randomized phase III trial is studying dexamethasone and aspirin when given~     together with two different schedules of diethylstilbestrol to compare how well they work in~     treating patients with locally advanced or metastatic prostate cancer.~   "
247232|NCT00316914|"~     RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused~     by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more~     effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients~     receiving combination chemotherapy.~      PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate~     to see how well they work compared to a placebo in preventing neurotoxicity caused by~     oxaliplatin in patients receiving combination chemotherapy for stage II, stage III, or stage~     IV colorectal cancer that has been completely removed by surgery.~   "
247233|NCT00316901|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography and computed~     tomography scan (done before and after cellular adoptive immunotherapy), may help doctors~     predict a patient's response to treatment and help plan the best treatment.~      PURPOSE: This phase II trial is studying how well positron emission tomography and computed~     tomography scan predicts response in patients with metastatic melanoma or kidney cancer who~     are undergoing cellular adoptive immunotherapy on a Surgery Branch clinical trial.~   "
247234|NCT00316888|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others~     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,~     such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Cetuximab may help cisplatin and fluorouracil work~     better by making tumor cells more sensitive to the drugs. It may also make tumor cells more~     sensitive to radiation therapy. Giving cetuximab together with chemotherapy and radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin,~     fluorouracil, and radiation therapy works in treating immunocompetent patients with stage I~     (closed to accrual as of 11/3/2008), stage II, (some stage II closed to accrual as of~     11/3/2008) or stage III anal cancer.~   "
247235|NCT00316875|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride~     liposome work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving lapatinib together with doxorubicin~     hydrochloride liposome may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of doxorubicin~     hydrochloride liposome when given together with lapatinib in treating patients with~     metastatic breast cancer.~   "
247236|NCT00316862|"~     This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together~     with radiation therapy works in treating patients with esophageal cancer or gastroesophageal~     junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin~     and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with~     radiation therapy before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed.~   "
247237|NCT00316849|"~     This phase I trial is studying the side effects and best dose of temsirolimus when given~     together with temozolomide and radiation therapy in treating patients with newly diagnosed~     glioblastoma multiforme. Temsirolimus may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     temsirolimus together with temozolomide and radiation therapy may kill more tumor cells.~   "
247238|NCT00316836|"~     RATIONALE: Understanding the relationship between breast density, levels of hormones in the~     blood, and levels of anticancer drugs in the blood may help improve the ability to plan~     effective treatment for women with invasive breast cancer.~      PURPOSE: This clinical trial is studying the relationship between breast density and blood~     levels of hormones and anticancer drugs in women with invasive breast cancer who are~     receiving exemestane or anastrozole.~   "
247239|NCT00316823|"~     RATIONALE: Finding genetic markers for thyroid cancer in a biopsy specimen may help doctors~     diagnose thyroid cancer.~      PURPOSE: This clinical trial is studying how well genetic analysis works in diagnosing~     thyroid cancer in patients with thyroid nodules.~   "
247240|NCT00316810|"~     The purpose of this study is to determine and compare the efficacy of Campath-1H/Tacrolimus~     versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type~     1-diabetic patients undergoing simultaneous pancreas-kidney allograft transplantation as well~     as to evaluate the safety of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF in terms of~     drug-related complications and immunosuppression-associated complications.~   "
247241|NCT00316797|"~     The initial study of [123I] INER will be completed in two parts. Once Part A (Preliminary~     whole body biodistribution) is completed, Part B (Serial dynamic SPECT assessment of regional~     brain uptake and washout and plasma metabolite analysis to determine the brain penetrance and~     regional distribution and washout counts following 123-I INER injection) will commence. All~     study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and~     Molecular NeuroImaging (MNI) in New Haven, CT. All subjects will undergo written informed~     consent and a screening evaluation including baseline clinical laboratory testing, and a~     baseline physical and neurological evaluation.~   "
247242|NCT00316784|"~     The study objective is the eluciation of the dose-response function in efficacy (and possibly~     safety) in order to determine an optimal dose with respect to efficacy and safety. The study~     is designed with three dose levels and one placebo control.~   "
247243|NCT00316771|"~     This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor~     (4) in patients with RA currently having an inadequate clinical response to methotrexate.~     Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75~     bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time~     on study treatment is <3 months, and the target sample size is 100-500 individuals.~   "
247244|NCT00316758|"~     This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses~     ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in~     patients with type 2 diabetes. Eligible patients will be those who have completed study~     BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will~     continue on the same treatment regimen (mono or combination therapy) as they received in the~     initial study. The anticipated time on study treatment is 3-12 months, and the target sample~     size is 100-500 individuals.~   "
247245|NCT00316745|"~     This randomized phase III study compares safety and efficacy of two sequence arms in advanced~     colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm~     A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing~     regimen (arm B).~   "
247246|NCT00316732|"~     This study was designed to assess the effectiveness of dutasteride in the actual clinical~     practice of prostate assessment clinics in the UK in accordance with best practice over a~     12-month period.~   "
247247|NCT00316719|"~     This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with~     lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week~     periods.~   "
247248|NCT00316706|"~     This protocol posting deals with objectives & outcome measures of the extension phase up to~     Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of~     the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by~     enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary~     phase are presented in a separate protocol posting (NCT00196924).~      The long-term follow-up study will be blinded until the primary study is unblinded and will~     be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924).~     During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the~     primary study will continue their participation in the follow-up study until Month 48.~     Subjects in the Control group (Havrix®) will attend one further visit as their last study~     visit.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
247249|NCT00316693|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the~     uterus or womb). This infection may go away by itself, but if it does not go away (this is~     called persistent infection), it can lead in women over a long period of time to cancer of~     the cervix. This study will evaluate the efficacy in prevention of persistent HPV-16 or~     HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK~     Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 -~     25 years of age at study start. Approximately 1000 study subjects will either receive the HPV~     vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to~     a 0-1-6 month schedule.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
247250|NCT00316680|"~     A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK~     Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis~     B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories~     (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b~     vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be~     assessed as well.~   "
247251|NCT00316667|"~     The aim is to assess the population prevalence of risk factors for different chronic diseases~     such as cardiovascular disease, type 2 diabetes, osteoporosis, asthma, and allergy. Risk~     factors include genetic and serologic biomarkers, questionnaire data on health and lifestyle.~     There are many hypotheses under study for each research field.~   "
247252|NCT00316654|"~     Persistence of Antibody Response to N. meningitidis Group C in Children~   "
247253|NCT00316641|"~     The purpose of this study is to determine whether the Lipid-lowing Tea is effective and safe~     in the treatment of Hyperlipidemia Patients~   "
247257|NCT00316589|"~     The purpose of this study is to gather information on the safety and immunogenicity of an~     investigational smallpox vaccine in HIV infected populations. Subjects will receive two~     vaccinations~   "
247258|NCT00316576|"~     Associations between angiotensin-converting enzyme gene polymorphism and occurrence and~     outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already~     been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the~     I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be~     associated with a higher risk of acute renal failure in critically ill patients.~   "
247259|NCT00316563|"~     To investigate delta-9-tetrahydrocannabinol's (THC) ability to increase food intake and~     improve food enjoyment for advanced cancer patients with taste and/or smell (chemosensory)~     abnormalities.~   "
247260|NCT00316550|"~     The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1)~     antagonist, in subjects with Irritable Bowel Syndrome.~   "
247261|NCT00316537|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of low dose~     nicotine gel in patients with chronic diabetic ulcers~   "
247262|NCT00316524|"~     The primary objective of this study is to evaluate the immune response after a single~     vaccination of pre-immune subjects compared to two vaccinations in naive subjects.~      In addition the study further investigates the safety profile of MVA-BN® in a healthy~     population compared to placebo.~   "
247263|NCT00316511|"~     This is a dose escalation study. Patients will be enrolled in cohorts of three patients each,~     and escalation of dose to the next cohort will be determined based on dose-limiting toxicity~     (DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of~     intravenous L-NDDP. Once the MTD has been determined, an additional four patients will be~     enrolled at that dose level. While the MTD is determined based on safety data from each~     cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional~     cycles of L-NDDP at the same dose as their starting dose until documented progression,~     unacceptable toxicity, or another off study criterion is met. Patients who have not met any~     of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is~     determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also~     determine the pharmacokinetic profile of L-NDDP administration. Clinical activity of L-NDDP~     in solid tumor patients will be assessed as tumor response using the Response Evaluation~     Criteria in Solid Tumors (RECIST) criteria. Clinical activity of L-NDDP in B-cell lymphoma~     patients will be assessed using the International Working Group recommendations.~   "
247264|NCT00316498|"~     This study is done in conjunction with a trial, conducted at Columbia University College of~     Physicians and Surgeons in New York and the Royal Manchester Children's Hospital in England,~     to examine the effectiveness of a new drug called OGT 918 for treating Niemann-Pick Type C~     (NPC) disease. Patients with this genetic disorder do not transport lipids (fatty substances)~     in their cells, resulting in problems of the liver, spleen and brain. An early sign of NPC is~     a reduced ability to move the eyes rapidly up and down or from side to side. These voluntary~     eye movements are called saccades. Patients in the OGT 918 trial who participate in this~     sub-study will have their saccadic eye movements measured to see if improvement occurs with~     OGT 918 treatment.~      Patients with Niemann-Pick Type C disease 12 years of age and older who are enrolled in the~     OGT 918 trial described above may be eligible for this study.~      Participants will have both vertical (up and down) and horizontal (side to side) saccadic eye~     movements measured at two time points before starting treatment with OGT 918 and after 12~     months of treatment. For the test, patients sit in a chair with their head positioned as for~     a regular eye examination (steadied by a chin cup and headrest) and follow with their eyes a~     series of lights or laser spots moving on a screen at a distance of 1 meter (3 feet). During~     the test, patients wear either special recording glasses, infrared goggles, or special~     contact lenses for measuring eye movements. A full eye evaluation lasts about 1 hour, and~     each eye is evaluated twice. The evaluations are separated in time by at least an hour, and~     possibly a day.~   "
247265|NCT00316485|"~     Under this study, patients who require removal of their third molars (wisdom teeth) will be~     diagnosed, evaluated and treated. In addition, tooth, bone and gum tissue samples will be~     collected for use in bone, wound healing, microbiology and genetic research.~      Patients 16-50 years of age who require wisdom tooth removal may be eligible for this study.~     Participants may have one or all of their wisdom teeth removed at one time. The surgery is~     done under local anesthetic. In addition, conscious sedation may be administered, if the~     patient wishes.~      Besides wisdom tooth removal, patients are asked to donate a small sample of jaw bone (from~     the lining of the inner wall of the tooth socket) and gum tissue (from the area of the~     surgical site). The samples are collected at the same time as the tooth extraction. The bone~     sample is about the size of a pencil point (1.5 millimeters wide and 3 millimeters long) and~     the gum tissue sample is 1 millimeter. Removal of these samples should not cause any~     additional discomfort or increase the time required for the surgery or for healing.~   "
247266|NCT00316472|"~     Elevated phosphorus levels are a common problem in dialysis patients. However, it is~     associated with an increase in death and hospitalizations. Current treatment is comprised of~     dietary modifications and phosphorus binders - though this is often not enough for many of~     our patients. Our trial investigates the use of niacinamide, a form of vitamin B, in~     decreasing serum phosphorus levels.~   "
247267|NCT00316459|"~     To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as~     assessed by the QTc interval.~   "
247268|NCT00316446|"~     The purpose of this study is to determine if gastric bypass patients experience~     hypoventilation in the immediate postoperative period, and to what degree.~   "
247269|NCT00316433|"~     The purpose of this study is to determine the safety and effectiveness of the combination of~     oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small~     cell lung cancer.~   "
247270|NCT00316420|"~     The purpose of this study is to test the effectiveness and safety of the drug combination of~     gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.~   "
247271|NCT00316407|"~     The purpose of this study is to determine the effectiveness, safety, tolerability and best~     dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.~   "
247273|NCT00316381|"~     The purpose of the study is to compare the efficiency of a sorted subpopulation of~     CD34+/CXCR4+ cells and unselected bone marrow-derived progenitor cells in the treatment of~     patients with acute myocardial infarction and a low left ventricular ejection fraction.~   "
247274|NCT00316368|"~     The purpose of this study is to determine, using echocardiography, whether bi-ventricular~     pacing improves the contractile force by resynchronizing both ventricles, thereby improving~     and/or correcting the paradoxical septal movement.~      Primary Hypothesis:~        -  Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in~          cardiac index (CI) as compared with standard atrio-right ventricular pacing.~      Secondary Hypothesis:~        -  Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in~          cardiac index (CI) as compared with atrio-left ventricular pacing and right atrium~          pacing.~   "
247275|NCT00316355|"~     This study will determine the effectiveness and cost-effectiveness of a stepped-care~     treatment program for people with obsessive-compulsive disorder.~   "
247276|NCT00316342|"~     The purpose of this study is to examine the effect of back supports plus education upon~     recovery from a work-related low back disorder. The study tests the hypothesis: the use of~     back supports plus health education is not different from health education alone in promoting~     recovery from a work-related low back disorder in consideration of personal, health, and job~     factors. Significant improvements in physical health, neurogenic symptoms, back pain~     disability, and low back pain were observed over the twelve months of study follow-up. No~     statistically significant difference between the study groups was found with respect to these~     measures.~   "
247277|NCT00316329|"~     Primary Objective:~        -  To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on~          D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination), as~          a single daily dose, in comparison with administration of Coartem®~          (artemether+lumefantrine).~      Secondary Objectives:~      To compare the 3 treatment groups in terms of:~        -  clinical and parasitological efficacy on D14 and D28 on the global population and on the~          subpopulation consisting of children aged under 5 years and that for patients aged 5~          years and over~        -  clinical and laboratory safety~        -  time to parasite clearance~        -  time to clearance of fever~        -  changes in gametocytaemia~        -  impact on anaemia~   "
247278|NCT00316316|"~     This study will determine the effectiveness of adding motivational interviewing to cognitive~     behavioral therapy, consisting of exposure and ritual prevention, in improving treatment~     outcomes in people with obsessive-compulsive disorder.~   "
247279|NCT00316303|"~     This study will determine the effectiveness of the STIRR (Screen, Test, Immunize, Reduce~     risk, and Refer) intervention in increasing rates of testing, immunization, referral, and~     treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental~     disorder and a substance abuse disorder.~   "
247280|NCT00316290|"~     This study will determine the effectiveness of integrated parent training versus standard~     behavioral parent training in treating depression and stress in mothers of children with~     attention deficit hyperactivity disorder (ADHD).~   "
247281|NCT00316277|"~     The purpose of this study is to determine whether treatment outcome for subjects dependent on~     prescription opioid analgesics can be improved by adding individual drug counseling to the~     prescription of buprenorphine/naloxone with standard medical management. This will be~     examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization~     treatment for those who do not respond successfully to the initial treatment; and c) a~     long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.~   "
247282|NCT00316264|"~     This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and~     palivizumab were administered sequentially to high-risk children during the same respiratory~     syncytial virus (RSV) season. A control group was administered only motavizumab.~   "
247283|NCT00316251|"~     The purpose of this study is to determine the effects of Power Plate vibration therapy on~     balance as measured by the NeuroCom Balance Master.~   "
247284|NCT00316238|"~     To investigate dose-response of Rapid Acting Intramuscular Olanzapine in Agitated Patients~     with Schizophrenia~   "
247285|NCT00316225|"~     This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer~     patients with fluid around their lungs or abdomen.~   "
247286|NCT00316212|"~     The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion~     that are well-tolerated and which reduce postoperative bleeding and blood product~     transfusion.~   "
247287|NCT00316199|"~     The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel~     combination administered on a 3-weekly schedule in Chinese patients with unresectable,~     locally recurrent breast cancer or metastatic breast cancer.~   "
247288|NCT00316186|"~     This study was designed to find the safest and most effective dose of a combination of two~     chemotherapy drugs, Hycamtin® (topotecan) and Paraplatin® (carboplatin), in people with~     extensive disease small cell lung cancer.~   "
247289|NCT00316173|"~     This study was designed to find the most effective and safest doses of both HYCAMTIN and~     CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow~     researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.~   "
247290|NCT00316160|"~     Effects of two depression medication on sexual functioning~   "
247291|NCT00316147|"~     In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will~     be randomly allocated into two groups:~        -  one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B~          virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at~          6-10-14 weeks of age~        -  the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of~          age~   "
247292|NCT00316134|"~     The purpose of this clinical trial is to evaluate the ability of various biomarkers measured~     in serum and/or pleural fluids to estimate the risk of finding cancer in patients with~     undiagnosed pleural effusions. An algorithm for prediction of the risk of finding cancer in~     the patient using an optimal combination of markers will be developed, and patients will be~     categorized as having a low, moderate, or high risk of finding cancer that might be used to~     more effectively triage patients.~   "
247294|NCT00316108|"~     The purpose of this study is to determine whether morbidity and mortality for high-risk~     surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX~     and EZ System distal protection device will be less than or equal to that of objective~     performance criteria (OPC) derived from historic controls undergoing surgical intervention~     with a carotid endarterectomy (CEA).~   "
247295|NCT00316095|"~     This study will investigate two registered drugs, one for the treatment of high blood~     pressure and one for the treatment of elevated cholesterol. High blood pressure~     (hypertension) is a common medical condition affecting millions of people worldwide. A wide~     variety of effective drug treatments is available to reduce blood pressure. Elevated~     cholesterol (hypercholesterolemia) is a common medical condition affecting people worldwide.~     A wide variety of effective drug treatments is available to reduce cholesterol levels.~      Hypertension and hypercholesterolemia often occur together. They are both important risk~     factors for the development of heart and vessel diseases (e.g. heart attack or stroke).~     Current guidelines advise treatment of high blood pressure and elevated cholesterol to reduce~     the risk of cardiovascular diseases. This study will test the simultaneous use of a drug to~     reduce blood pressure and a drug to reduce elevated cholesterol. Both drugs are registered~     and are effective. The drug for treatment of high blood pressure is telmisartan Micardis).~     The drug for treatment of elevated cholesterol is simvastatin (Zocor). Since hypertension and~     hypercholesterolemia frequently occur together, the purpose of this study is to investigate~     whether both drugs can be used simultaneously. A low dose and a high dose of these drugs will~     be used. It will be investigated whether each of the drugs is still as effective when given~     together, at the same time of day, with the other drug.~   "
247296|NCT00316082|"~     The purpose of this trial is to understand if saxagliptin is more effective than placebo as a~     treatment for type 2 diabetic subjects who are not controlled with diet and exercise~   "
247297|NCT00001675|"~     This study was designed to learn more about the areas of the brain involved in the experience~     of positive and negative emotions.~      Patients who would like to participate in this study will first undergo a screening process~     to see if they will be eligible for the study. Patients eligible to participate in the study~     will go through two sessions.~      During session one, researchers will attempt to evoke positive and negative emotions by~     showing patients slides of different emotion-arousing stimuli (pictures of pleasant and~     unpleasant scenes). While patients are viewing these slides, researchers will be measuring~     patient's heart rate, sweating, and eye-blinking.~      During session two, patients will undergo an MRI of the brain while seeing similar~     emotion-arousing pictures as in session one. In addition, patients may be asked to play a~     simple computer game for a reward of money while researchers use the MRI to measure brain~     activity.~      Researchers hope to develop methods to evoke positive and negative emotions and~     simultaneously (at the same time) see brain activation in normal volunteers, alcoholics, and~     recovered alcoholics.<TAB>~   "
247298|NCT00001673|"~     This protocol has three purposes: (1) to evaluate subjects for inclusion or exclusion from~     other NIAAA protocols; (2) to provide a common set of descriptive information that will be~     available on all NIAAA research subjects; (3) to allow NIAAA medical and nursing staff to~     treat alcoholic patients for acute alcohol intoxication or alcohol withdrawal before~     requiring patients to consent to evaluation for participation in research studies.~      Information collected will include such items as psychiatric diagnoses, presence or absence~     of brain, liver or other organ damage, history of the amount of past alcohol consumption,~     other substance use and family history of alcoholism. This information will allow~     investigators to determine for which, if any, NIAAA research studies a subject is eligible.~     In order to avoid requiring intoxicated subjects to consent for procedures such as HIV~     testing, psychiatric interviews, and Magnetic Resonance Imaging (MRI) of the brain we will~     obtain consent from all alcoholic subjects in two phases, using two separate consent forms.~     The first consent form will express the subject's desire to be admitted to the NIAAA~     inpatient unit for the purpose of treatment for alcoholism and will authorize only medical~     evaluation and treatment for alcoholism and associated problems. After an alcoholic subject~     has been admitted to the inpatient unit and is judged to be no longer intoxicated or~     suffering from acute alcohol withdrawal he or she will be presented with the second consent~     which will describe the evaluation for participation in other NIAAA research studies.~     Non-alcoholic, healthy controls will sign only one consent form describing the data to be~     collected and evaluation for participation in other NIAAA research studies.~   "
247299|NCT00316069|"~     This study is designed for the collection of stem cells from the bloodstream for use in~     research studies. These cells will be studied to determine if they have unique features~     particular to the donor that may or may not affect their use for developing new treatments.~      Volunteers with or without a blood disease may be eligible to donate stem cells for this~     study. Women who are pregnant or breastfeeding may not enroll.~      Donors are evaluated with a medical history and physical examination, blood tests and an~     ultrasound examination of the spleen. They then undergo stem cell mobilization and apheresis~     as follows:~      Donors are given injections of a hormone called G-CSF every day for 5 days to stimulate~     release of stem cells from the bone marrow into the bloodstream for collection. On the day of~     the last injection, donors undergo apheresis to obtain white cells and stem cells. For this~     procedure, blood is withdrawn through a catheter (plastic tube) placed in a vein and directed~     into a machine where the white cells and stem cells are separated from the rest of the blood~     by a spinning process. These cells are extracted and collected in a bag inside the machine,~     and the rest of the blood is returned to the donor through a second catheter in a vein in the~     other arm. The procedure takes 4 to 5 hours.~   "
247300|NCT00316056|"~     This study will investigate how people learn best about genetics. It involves participating~     in activities in NHGRI's Immersive Virtual Environment Laboratory (IVE lab), where digital~     virtual worlds are created that appear to surround the subject when he or she wears a~     head-mounted display.~      English-speaking men and women between 18 and 40 years of age may be eligible for this study.~     Participants are randomly assigned to one of two groups, each of which receives a different~     type of information, once in the IVE lab. Subjects complete a questionnaire before and after~     performing the activities in the lab. The questionnaire evaluates the subject's knowledge of~     genetics and tests some reading and number skills.~   "
247301|NCT00316043|"~     The aim of the study is to describe the current clinical management of young children with~     urinary tract infections in Dutch primary care and also to describe the possibilities for~     improvement and potential cost-efficiency of improved care in the light of preventing renal~     failure.~   "
247302|NCT00316030|"~     Bexarotene may be useful in the treatment of Acute Myeloid Leukemia (AML). This is the first~     study on the use of bexarotene to treat patients with AML. The main purpose of this study is~     to establish the proper dose of bexarotene when used to treat AML. The side effect profile of~     bexarotene in patients with AML will also be explored.~   "
247303|NCT00316017|"~     The purpose of this study is to determine if hypertonic saline with and without dextran can~     improve overall survival in victims of trauma with shock.~      Injury and lost blood from trauma can cause your body to be in shock (low blood pressure~     related to blood loss). This decreased blood flow can lead to organ damage. In order to~     restore the blood pressure and blood flow, the medics give fluids into the patients' veins as~     soon as possible. This is called resuscitation. The resuscitation fluid most commonly used~     is isotonic or one that is the same concentration as the blood. The investigators are~     trying to determine if infusing a hypertonic fluid (or one more concentrated than the~     blood) can increase the blood pressure and restore blood flow more efficiently. The~     hypertonic fluids the investigators are using are called hypertonic saline with dextran (HSD)~     and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly~     more concentrated than your blood. Dextran is a sugar solution.~   "
247304|NCT00316004|"~     The purpose of this study is to determine if hypertonic saline with and without dextran can~     improve neurologic outcomes in victims of severe traumatic brain injury (TBI).~      Injury and lost blood from trauma can cause your body to go into shock (low blood pressure~     related to blood loss). This decreased blood flow can lead to organ damage. In order to~     restore the blood pressure and blood flow, the medics give fluids into the patients' veins as~     soon as possible. This is called resuscitation. The fluid most commonly used is isotonic~     or one that is the same salt concentration as the blood. The investigators are trying to~     determine if infusing a hypertonic fluid or one more concentrated than the blood can~     increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids~     they are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no~     dextran). Hypertonic saline is a salt solution that is slightly more concentrated than blood.~     Dextran is a sugar solution.~   "
247305|NCT00315991|"~     The purpose of this study is to test a training program for parents of children with T1DM.~   "
247306|NCT00315978|"~     The purpose of this study is to determine whether providing patients with information about~     their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows~     them to make appropriate decisions about heart disease prevention.~   "
247307|NCT00315965|"~     Using a rapidly responding nitric oxide analyzer in a new developed modular~     lung-function-setup we are going to measure steady-state NO diffusing capacity in 107 healthy~     subjects (age 6-45 years). The results will be compared to those measured by using carbon~     monoxide single-breath estimates. We like to show that the new method is sufficient to~     measure exactly lung diffusion capacity in this collective.~   "
247308|NCT00315952|"~     University of Pittsburgh Medical Center (UPMC) diabetes research physicians are studying the~     action in muscle tissue of inhaled insulin (Exubera®) and infused (intravenous or IV)~     insulin on blood sugar control in people with type 1 diabetes. Type 1 diabetics often take~     2-4 shots of insulin every day. Exubera may offer an alternative to these insulin injections.~   "
247309|NCT00315939|"~     The purpose of this study is to test two newly developed computer programs, Integrated~     Biobehavioral Monitoring and Feedback (IBMF) IBMF-1 and IBMF-2. The computer programs are~     considered experimental. Both computer programs are being tested to see if they are useful in~     helping people with type 1 diabetes avoid low blood sugar episodes.~   "
247310|NCT00315926|"~     The purpose of this study is to assess whether treatment with melatonin can reduce cell~     damage and inflammatory stress response and thereby occurrence of myocardial injury after~     abdominal aortic surgery.~   "
247311|NCT00315913|"~     The purpose of this study is to determine whether propranolol is better than oxytocin for the~     treatment of labor abnormalities. The endpoint is the rate of vaginal delivery experienced by~     women receiving prolonged oxytocin versus propranolol.~   "
247312|NCT00315900|"~     The primary objective of the study is to assess the relative efficacy of Depakote ER and~     Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a~     Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of~     the study is to assess the relative tolerability of Depakote ER and Seroquel in this~     population. The primary hypothesis is that agitated dementia patients will demonstrate a~     significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while~     treated with Depakote ER compared to treatment with Seroquel.~   "
247313|NCT00315887|"~     The objective of this study is to assess the safety and efficacy of the buprenorphine~     transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and~     hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment~     intervention duration is 56 days during which time supplemental analgesic medication~     (ibuprofen) will be provided to all subjects in addition to study drug.~   "
247314|NCT00315874|"~     The objective of this study is to demonstrate the effectiveness and tolerability of the~     buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal~     system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain~     inadequately treated with non-opioid analgesics. The double-blind treatment intervention~     duration is 60 days.~   "
247315|NCT00315861|"~     Currently, no data exists regarding the safety and tolerability of a combination regimen~     utilizing weekly topotecan in combination with pemetrexed. Although both drugs are associated~     with myelosuppression, it is hoped that the utilization of the weekly topotecan dosing~     schedule will allow the drugs to be easily combined. This phase I trial will evaluate the~     safety and tolerability of weekly topotecan in combination with pemetrexed in patients with~     advanced solid tumors.~   "
247372|NCT00315120|"~     The purpose of this study is to determine whether osteopathic manipulative treatment (a type~     of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical~     therapy are effective in the treatment of chronic low back pain.~   "
247316|NCT00315848|"~     The objective of this study is to demonstrate the effectiveness and tolerability of the~     buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal~     system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain~     inadequately treated with non-opioid analgesics. The double-blind treatment intervention~     duration is 60 days.~   "
247317|NCT00315835|"~     The objective of this study is to assess the safety of the buprenorphine transdermal system~     (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to~     severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72~     hours during which time supplemental analgesic medication (intravenous morphine PCA) will be~     provided to all subjects in addition to study drug.~   "
247318|NCT00315822|"~     The investigators propose to test the hypothesis that the incidence of major complications~     related to infection or inadequate healing is reduced in morbidly obese patients given 80%~     inspired oxygen during, and for 12-18 hours after, surgery compared with patients given 80%~     oxygen only during surgery. The primary outcome will be a composite of major complications~     plausibly related to infection or healing.~   "
247319|NCT00315809|"~     The purpose of the study is to see if new methods can be used to determine why Multidrug~     Therapy (MDT), used to cure leprosy patients effectively for twenty years, is not as~     effective against Leprosy in the Philippines. Researchers do not know how people get infected~     with leprosy or what causes the disease to relapse after cure with adequate MDT. Blood, skin~     scrapings, nasal swabs and biopsies, will be collected from leprosy patients to perform tests~     related to the detection of the disease and the germ. The tests will be used to find out if~     the bacteria in the body are related to the bacteria found in other patients or contacts.~     This will help the researchers to know where these bacteria come from, and to see how they~     spread. Other tests will be performed to see if the bacteria can be killed by two common~     medicines given to leprosy patients. Study participants will include individuals age 18 and~     older presenting to Leonard Wood Memorial for the diagnosis and/or relapse of leprosy.~   "
247320|NCT00315796|"~     Pain is a common and difficult problem for patients with cancer. It has been reported that~     over 80% of cancer patients suffer from pain. Much of this pain is iatrogenic and related to~     procedures. Dr. Grossman recently demonstrated that most patients undergoing bone marrow~     biopsy have poor pain control during the procedure. Treatment of pain is almost entirely with~     analgesic medications, principally opioids. These medications have numerous undesirable~     effects such as sedation, confusion, hypotension and constipation that limit their efficacy~     and utility. Drs. Diette, Lechtzin, Rubin and colleagues recently demonstrated that use of~     nature sights and sounds (NSS), a simple, safe, and inexpensive intervention, decreases pain~     during fiberoptic bronchoscopy, a procedure commonly performed to diagnose cancer and to~     detect pulmonary complications of cancer therapy. Patients were randomly assigned to either~     standard care with intravenous narcotics and benzodiazepines or standard care coupled with~     view of a nature scene and use of nature sounds before, during, and after bronchoscopy. The~     group assigned to the NSS reported significantly better pain control than the control group.~     While these findings are novel and exciting, they raised several new questions that suggest~     logical extensions of this work. It is not known whether this intervention can be applied to~     patients in other settings, nor is it known whether comparison to standard care is an~     appropriate control group. Further, the mechanism of action of NSS needs to be determined.~     NSS may simply be a form of distraction therapy but it may have other properties. The theory~     of biophilia proposes there are specific elements in nature imagery that exert beneficial~     health effects. Because NSS appears to be a promising and safe intervention for the treatment~     of pain, these investigators plan to perform a controlled clinical trial in cancer patients~     undergoing invasive procedures. Patients will be randomly assigned to one of three arms,~     standard care, NSS, and a non-nature based distraction technique. We will study the efficacy~     of NSS for the management of procedure-related pain in oncology patients. The findings will~     provide necessary background information to develop more definitive studies of NSS that~     should be competitive for external funding. This exciting study will help develop a harmless,~     inexpensive method to treat pain in cancer patients, that may complement or replace analgesic~     medications.~   "
247321|NCT00315783|"~     Compare data (structural and functional) obtained by transthoracic rest echocardiography and~     magnetic resonance imaging (with gadolinium) in 30 patients with hypertrophic cardiomyopathy~   "
247322|NCT00315770|"~     This is a controlled, randomized, intervention trial (CRIT) with 20-40 year old overweight~     individuals (n = 320) across Europe in order to distinguish between biologically active~     components of seafood, i.e., seafood proteins and n-3 lipids, regarding their effects on risk~     factors for metabolic syndrome, bone health, and weight management.~   "
247323|NCT00315757|"~     The purpose of this study is to evaluate the efficacy (disease response) and safety of~     mapatumumab in combination with bortezomib and bortezomib alone in subjects with relapsed or~     refractory multiple myeloma (MM).~   "
247324|NCT00315744|"~     Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an~     adjustment of their asthma therapy. Current guidelines suggest that the treatment options are~     either an increased dose of inhaled corticosteroid or the addition of other therapy such as a~     long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to~     high dose ICS therapy are growth retardation and the suppression of the~     hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that~     a combination product that included a LABA as well as the ICS allowed to reduce the steroid~     dose and was still at least as effective in achieving asthma control as treatment with a~     higher dose of ICS. These treatment options shall be compared in the present study. Children~     who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized~     to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or~     fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of~     eight weeks.~   "
247325|NCT00315731|"~     Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131~     Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from~     testing done on blood samples drawn at 12 timepoints over the first 7 days following~     administration of the dosimetric dose. Whole body gamma camera images will be obtained on six~     days following the dosimetric dose. Organ and tumor dosimetry data will be generated from~     gamma camera counts of specific organs and tumor. All scans will be examined by an~     independent review panel to evaluate biodistribution of the radionuclide.~      Using the dosimetric data from three of the six imaging time points and the patient's weight,~     a patient-specific activity (mCi) of Iodine-131 will be calculated to deliver the desired~     total body dose of radiation (75 cGy). Patients will receive an infusion of unlabeled~     Tositumomab (450 mg) immediately followed by an infusion of the patient specific dose of~     tellurium-derived Iodine I 131 Tositumomab (35 mg) to deliver a total body dose (TBD) of 75~     cGy. Patients will be followed closely obtaining safety information during the post-treatment~     period, and for response and safety at 3,6,and 12 months during the first year, annually~     thereafter up to five years, and annually for additional safety and outcomes information up~     to 10 years.~   "
247326|NCT00315718|"~     In patients with diabetes mellitus type 2 stably adjusted to diet long-term intake of~     aqueous-ethanolic extract from Hintonia latiflora over more than 12 months leads to a~     statstically significant amelioration of parameters of glycaemic control (HbA1c, postprandial~     and fasting glucose) not acchievable with diet alone.~      As safety parameters, liver function tests and cardiovascular parameters are to be monitored.~     Adverse events are to be monitored.~   "
247327|NCT00315705|"~     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the~     treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute~     lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is~     based on the induction of complete responses. Randomized trials demonstrating increased~     survival or other clinical benefit have not been conducted.~      The purpose of the phase 1 portion of this study was to determine if clofarabine added to a~     combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory~     acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the~     phase 2 portion of the study was to measure the effectiveness of the combination therapy in~     children with ALL.~   "
247328|NCT00315692|"~     The purpose of this clinical trial is to evaluate the ability of multiple serum biomarkers to~     estimate the risk of ovarian cancer in women presenting with pelvic mass (defined as a~     simple, complex or a solid ovarian cyst / pelvic mass).~   "
247329|NCT00315679|"~     This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline~     (oxpentifylline) for the treatment of recurrent mouth ulcers.~   "
247330|NCT00315666|"~     The purpose of this study is to test whether memantine has a prophylactic effect on chronic~     tension-type headaches.~   "
247331|NCT00315653|"~     The purpose of this clinical trial is to evaluate the ability of urinary Survivin mRNA~     measurement to estimate the risk of bladder cancer at the time of cystoscopy in subjects with~     no prior history of bladder cancer presenting with microscopic or macroscopic hematuria.~   "
247332|NCT00315640|"~     The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot~     when administered for the treatment of elevated IOP following treatment with steroids.~   "
247333|NCT00315627|"~     The purposes of this study are:~        1. To reverse hyperglycemia and insulin dependency in patients with type 1 diabetes~          mellitus through islet transplantation utilizing steroid free, calcineurin-inhibitor~          free immunosuppression.~        2. To assess the long-term function of successful islet transplants in patients with type 1~          diabetes mellitus utilizing islets that have undergone a period of culture.~        3. To determine whether the natural history of the microvascular, macrovascular, and~          neuropathic complications are altered following the successful transplantation of~          islets.~   "
247334|NCT00315614|"~     SPECIFIC AIMS:~        -  To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes~          mellitus by islet cell transplantation.~        -  To induce a state of donor specific tolerance and eliminate the need for continuous~          immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells~          with islets and utilization of the monoclonal antibody Campath-1H for induction of~          Immunosuppression.~        -  To assess long-term function of successful islet cell transplants in patients with Type~          1 diabetes mellitus.~        -  To determine whether the natural history of the microvascular, macrovascular and~          neuropathic complications are altered following successful transplantation of islet~   "
247335|NCT00315601|"~     The major objectives of this research are to see how much, and for how long, telithromycin~     and azithromycin get into the fluids and cells of the lung.~   "
247336|NCT00315588|"~     The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell~     transplantation, in patients with type 1 diabetes mellitus who have a stable kidney~     allograft.~   "
247337|NCT00315575|"~     The purpose of this study is to develop imaging techniques that can distinguish functional~     brain changes in people at high risk for dementia years prior to onset of clinical memory~     problems from those with normal changes of aging.~   "
247338|NCT00315562|"~     Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized~     ischemic stroke caused by high-grade carotid stenosis.~   "
247339|NCT00315549|"~     This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel~     treatment group study in subjects equal to or over 13 years of age, with Streptococcus~     pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400~     mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg~     over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules~     will be dispensed to maintain the blind between the treatment groups.A positive rapid~     identification test for streptococcal Group A antigen will be required for all subjects at~     Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture,~     identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.~   "
247340|NCT00315536|"~     Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and~     blood pressure in children.To differentiate between contractility and the effect of the~     circulating volume, some of the subjects will receive additional fluid.This will be evaluated~     using two transthoracic echocardiac exams within the first 30 min of anesthesia.~   "
247341|NCT00315523|"~     To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered~     once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring~     in subjects exposed to ragweed pollen in an environmental exposure unit.~   "
247342|NCT00315510|"~     Statins, including rosuvastatin, are drugs that lower plasma cholesterol and prevent~     atherosclerotic disease. Recent preclinical evidence suggests that statins also increase~     tissue tolerance to ischemia-reperfusion injury.~      This is a randomized, double blind, parallel designed study comparing the effect of 1 week~     treatment with rosuvastatin (20 mg, once a day) with placebo on forearm ischemia-reperfusion~     injury in healthy male volunteers. Forearm ischemia-reperfusion injury is quantified with~     Tc-99m-annexin A5 scintigraphy of the hands after a standardized ischemic exercise test. For~     this purpose, Tc-99m-rh-annexin A5 (400 MBq; < 5 mSv) is injected intravenously upon~     reperfusion, followed by scintigraphy of both hands with a gamma camera at 1 and 4 hours~     after injection. Annexin A5 targeting is calculated as the percentage difference in activity~     (counts/pixel) between the thenar muscles of both hands.~   "
247343|NCT00315497|"~     Giant cell arteritis (GCA), also known as temporal arteritis, is a disease that usually only~     occurs in older adults. GCA causes inflammation of blood vessels, or vasculitis. In order to~     properly treat this disease, it is critical that the level of disease activity can be~     determined over the course of the disease. The purpose of this study is to determine new~     biological markers, or biomarkers, that may be used to assess the severity of disease in~     people with GCA.~   "
247344|NCT00315484|"~     The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa~     (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other~     week) in anemic cancer patients receiving chemotherapy.~   "
247345|NCT00315471|"~     Takayasu's arteritis is a rare disorder that causes swelling and damage to the large arteries~     in the body, such as the aorta. In order to ensure proper treatment, measuring disease~     activity is critical. The purpose of this study is to establish new biological markers~     (biomarkers) to assess the severity of disease in people with Takayasu's arteritis.~   "
247346|NCT00315458|"~     The original objective of this study was to assess the safety and efficacy of the~     buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal~     system in subjects with moderate to severe osteoarthritis pain. However, this study was~     terminated early with only 35% of the planned sample size, therefore the primary objective is~     changed to focus on the safety evaluations.~   "
247347|NCT00315445|"~     The objective of this study is to assess the safety of the buprenorphine transdermal system~     (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/~     acetaminophen in subjects with chronic back pain. The double-blind treatment intervention~     duration is 84 days during which time supplemental analgesic medication (non-steroidal~     anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.~   "
247348|NCT00315432|"~     The purpose of this study was to describe the time course and extent of hemoglobin (Hb)~     changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and~     Ribavirin)-induced anemia In HCV(hepatitis C virus)/HIV (human immunodeficiency virus)~     co-Infected subjects.~   "
247349|NCT00315419|"~     Bone marrow failure syndromes (BMFS) are rare disorders characterized by dysfunctional~     hematopoietic stem cells, which give rise to all red and white blood cells. The deficiency of~     blood cells, or cytopenia, caused by this malfunction leads to an assortment of diseases and~     disorders, all of which are characterized as BMFS. Because these diseases are rare,~     conducting research on them is difficult, and standards of treatment for most BMFS have yet~     to be developed. This study will collect clinical and laboratory data from people with BMFS~     to identify the characteristics and biological markers associated with these diseases over~     time. This information will assist doctors and researchers to develop better therapies and~     diagnostic tests that will help improve the management of BMFS and cytopenias.~   "
247350|NCT00315406|"~     Polyarteritis nodosa (PAN) is a rare immune system disorder that causes swelling and damage~     to small- and medium-sized blood vessels in the body. In order to properly treat this~     disease, it is critical that the level of disease activity can be determined over the course~     of the disease. The purpose of this study is to determine new biological markers, or~     biomarkers, that may be used to assess the severity of disease in people with PAN.~   "
247351|NCT00315393|"~     Granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA) are two~     rare immune system disorders that cause the inflammation of blood vessels, or vasculitis. In~     order to properly treat these diseases, it is critical that the level of disease activity can~     be determined over the course of the disease. The purpose of this study is to determine new~     biological markers, or biomarkers, that may be used to assess the severity of disease in~     people with GPA or MPA.~   "
247352|NCT00315380|"~     Eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA) is a rare immune system~     disorder that causes asthma, an excessive number of eosinophils (a type of white blood cell)~     in the blood, and the inflammation of blood vessels, or vasculitis. In order to properly~     treat EGPA, it is critical that the level of disease activity can be determined over the~     course of the disease. The purpose of this study is to determine new biological markers, or~     biomarkers, that may be used to assess the severity of this disease in people with EGPA.~   "
247353|NCT00315367|"~     The purpose of this study is to determine if medication designed to improve memory will help~     patients with Multiple Sclerosis (MS) who are experiencing memory problems using fMRI to~     track brain activity.~   "
247354|NCT00315354|"~     The aim of this study is to evaluate the effects of three dominant dietary patterns -~     conventional low-fat, low-glycemic index (GI) and very-low-carbohydrate - on energy~     metabolism and heart disease risk factors following weight loss in obese young adults in a~     feeding study~   "
247355|NCT00315341|"~     The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone~     (BUP/NX) and methadone (MET) on indices of hepatic safety.~   "
247356|NCT00315328|"~     The purpose of this study is:~        -  To compare the effectiveness of weekend atropine plus near activities and daily patching~          plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia~          (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.~        -  To determine the maximum improvement in vision of the amblyopic eye with each treatment.~        -  To determine whether amblyopia is associated with structural abnormalities of optic~          nerve fiber layer.~   "
247357|NCT00315315|"~     The purpose of this study is:~        -  To report the success proportions for the treatment of persistent nasolacrimal duct~          obstruction for three surgical procedures: balloon catheter dilation, nasolacrimal~          intubation, and simple probing.~        -  To obtain descriptive data regarding symptoms and quality of life in patients receiving~          each type of surgical procedure, and to compare success proportions between patients~          undergoing balloon catheter dilation and those undergoing nasolacrimal intubation.~   "
247358|NCT00315302|"~     The purpose of the study is:~        -  To compare the effectiveness and safety of weekend atropine augmented with a plano lens~          for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100)~          in children 3 to less than 7 years old.~        -  To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine~          treatment with and without a plano lens.~   "
247373|NCT00315107|"~     Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients~     with resistance to somatostatin analogs.~   "
247359|NCT00315289|"~     The purpose of this study is:~        -  To report the success proportions of simple probing within different age groups of~          patients under 24 months of age.~        -  To obtain descriptive data regarding symptoms and quality of life in patients receiving~          simple probing.~        -  To obtain similar data for simple probing in patients 24 months of age or older, for~          intubation in patients age 6 - <48 months, and for balloon catheter dilation in patients~          age 6 - <48 months.~   "
247360|NCT00315276|"~     The purpose of the study is to evaluate the efficacy and safety of modafinil administered~     once daily for 9 weeks at doses of 255, 340, 425, and 510 mg as treatment for adults with~     ADHD.~   "
247361|NCT00315263|"~     This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in~     small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain~     Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF).~   "
247362|NCT00315250|"~     We propose to build on preliminary data evaluating non-dopaminergic/non-motor clinical~     biomarkers to more fully assess these markers at the threshold of Parkinson disease (PD).~      Development of reliable biomarkers for both dopaminergic and non-dopaminergic manifestations~     of Parkinson disease (PD) and related disorders may dramatically accelerate research on PD~     etiology, pathophysiology, and therapeutics. Biomarkers are broadly defined as~     characteristics that are objectively measured and evaluated as indicators of normal~     biological processes, pathogenic processes, or pharmacologic responses to a therapeutic~     intervention. Specific biomarkers may be useful at the onset of neurodegeneration, the onset~     of disease, and/or to mark disease progression.~   "
247363|NCT00315237|"~     The purpose of this clinical research study is to learn if patients who receive vinflunine~     plus best supportive care live longer than patients who receive best supportive care alone.~     This study will also investigate patient benefit, safety and whether or not vinflunine~     shrinks or slows the growth of the cancer.~   "
247364|NCT00315224|"~     The present work examines the impact of pulse pressure as a footprint of vascular ageing on~     cardiovascular benefits of endurance training in elderly hypertensives. METHODS AND RESULTS:~     54 patients ≥ 60 years with antihypertensive treatment and diastolic 24h-ambulatory blood~     pressure (ABP) ≤ 90 mmHg are randomly assigned to sedentary activity or a heart-rate~     controlled 12 week exercise program, consisting of walking on a treadmill at target lactate~     concentrations of 2.5 ± 0.5 mmol/l. 24h-ambulatory blood pressure, physical performance,~     arterial elasticity, endothelium-derived vasodilation, quality of life, and weight are~     assessed at baseline and follow-up.~   "
247365|NCT00315211|"~     The purposes of this study are:~        -  To determine the overall response rate of patients treated with at least 2 cycles of~          this regimen.~        -  To determine the feasibility and toxicity of the combination of topotecan and docetaxel.~   "
247366|NCT00315198|"~     Ths purpose of this study is to determine whether near activities enhance the effect of~     patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared~     with distance activities in the treatment of moderate amblyopia and severe amblyopia in~     children 3 to <7 years old.~   "
247367|NCT00315185|"~     The purpose of this study is to determine the role of cetuximab (Erbitux) with chemotherapy~     for advanced colorectal carcinoma. This study will determine if this new agent can improve~     one's response to standard treatment.~   "
247368|NCT00315172|"~     Non-exercise activity thermogenesis (NEAT) is the energy expended engaging in daily~     activities such as maintenance of posture, fidgeting, and other activities not specifically~     designated as exercise. A growing body of evidence indicates that NEAT plays an important~     role in overall energy balance; for example, differences in NEAT account for the ease with~     which adults gain or lose weight during over- or under feeding. An intriguing and possibly~     modifiable component of NEAT is fidgeting-like activity. In lean and overweight adults,~     modulation of NEAT by augmenting fidgeting can increase short-term energy expenditure. It is~     unknown whether NEAT can be altered in children, or whether augmenting NEAT in children can~     change daily energy expenditure or body composition long-term. Children exhibit higher levels~     of daily activity than adults, suggesting potentially profound differences in energy balance.~     We propose to study the role of NEAT in children to determine if: a) the fidgeting component~     of NEAT can be measured accurately and reproducibly in children; b) NEAT can be increased by~     devices that remind children to engage in fidgeting-like activities; and c) manipulation of~     fidgeting-NEAT can significantly change energy expenditure and body composition. Thirty lean~     and thirty overweight children will be enrolled and treated in a pilot feasibility study. By~     adapting technologies developed to measure activity in adults, children's behavior and~     thermogenesis will be recorded and analyzed to study question (a). To address study questions~     (b) and (c), we will ask children to wear a timer that vibrate on a fixed interval schedule~     and be randomly assigned to two conditions: the intervention or active condition, during~     which children will be cued by the timer to engage in a fidgeting behavior (rapidly moving~     their heel up and down), and the control condition, during which children will be asked to~     perform a less thermogenic activity (noting the cue). Children will then cross over so that~     each child will complete both conditions. Primary outcome measures for question (a) will be~     changes in energy expenditure when subjects are asked to fidget in a laboratory environment.~     The correlation of these energy expenditure measurements with new activity monitoring~     technologies will also be obtained, so that such equipment can be used for measurements under~     free-living conditions. For study questions (b) and (c), compliance with prescribed fidgeting~     regimens in a free living environment and the changes in energy expenditure and body~     composition will be determined over a 2 week interval. This pilot study will enable the~     determination of the sample size needed to assess the efficacy of a longer term NEAT~     intervention in children.~   "
247369|NCT00315159|"~     The purpose of this study is to evaluate a less invasive procedure for the evaluation of the~     inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva. Each~     patient will undergo a sentinel lymph node dissection as well as resection of the primary~     tumor on the vulva. Patients who are determined to have sentinel nodes that are negative for~     metastatic disease will not receive a full groin dissection. Patients who have sentinel lymph~     nodes that contain metastasis will undergo a complete inguinal dissection. The study will~     evaluate the long-term outcomes in patients who receive only a sentinel lymph node dissection~     without a complete dissection. All patients entered onto the study will have a biopsy proven~     squamous cell carcinoma of the vulva. Each patient will be enrolled by a Gynecologic~     Oncologist practicing out of Women & Infants Hospital~   "
247370|NCT00315146|"~     The purpose of this pilot study is to compare two strategies intended to improve the health~     of overweight older adults by improving body composition. One strategy, resistance training,~     is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ~     agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These~     strategies will be used in conjunction with a hypocaloric diet and will be compared to a~     hypocaloric diet alone to determine if either of these strategies are superior in reducing~     visceral fat and preserving muscle mass.~   "
247371|NCT00315133|"~     The study evaluates the effect of inactivation of the immune system with chemotherapy and~     immunotherapy and infusion of bone marrow stem cells in early onset type 1 diabetes mellitus.~     We hypothesize that reprograming the immune system will stop immune aggression to the insulin~     producing cells allowing their regeneration and thus decreasing or eliminating the need of~     exogenous insulin.~   "
247374|NCT00315094|"~     The purpose of this study is to help people with home parenteral nutrition (HPN) to avoid~     infections and feelings of depression or fatigue and to test how their health and quality of~     life change over time. Another purpose is to test the nurse teaching sessions and the method~     of obtaining support from the peer partner through videophone.~   "
247375|NCT00315081|"~     Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the~     dopamine receptors in the pituitary.Schizophrenic patients suffering from a~     neuroleptic-induced hyperprolactinemia will be examined endocrinologically. Adverse drug~     effects and diagnoses will be confirmed by measuring hormones.~   "
247376|NCT00315068|"~     Catheter ablation using radiofrequency is a new therapeutic tool to treat atrial fibrillation~     with a higher success rate than medical therapy (80% versus less than 50% respectively).~     Because of the length of the intervention and of the risk of complications of the procedure,~     it would be important to determine success rate before the intervention. The information~     gained from this study will in all probability improve our estimation of the chances of a~     successful intervention and may enable us to take necessary therapeutic measures in case of~     an elevated risk of recurrence.~      Multiple studies suggest that the 2 markers in this study could provide information of this~     nature, however, their utility in the radiofrequency catheter ablation treatment of atrial~     fibrillation has never been demonstrated.~   "
247377|NCT00315055|"~     To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is~     non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three~     dose (2-3-4 month) primary series.~      Immunogenicity~        -  To assess pre- and post-primary series~        -  To assess pre- and post-booster series.~   "
247378|NCT00315042|"~     This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled,~     2 parallel treatment group study in subjects from 6 months to < 13 years of age, with~     Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either~     telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily~     for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5~     and 10 days respectively, to provide blinding to the different treatment regimens. A positive~     rapid identification test for streptococcal Group A antigen will be required for all subjects~     at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture,~     identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.~   "
247379|NCT00315029|"~     Background: The number of multiple pregnancies is considered to be the most important adverse~     effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or~     ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce~     this incidence remarkably. Unfortunately, former research has documented that cycles with SET~     maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of~     eSET will require a carefully chosen and thoroughly defined implementation strategy focussed~     on the couple undergoing the subfertility treatment. This trial will investigate the~     (cost)effectiveness of a combined patient centred implementation strategy.~      Objective: The main aim is to compare the effectiveness and costs of implementation of~     elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic~     sperm injection (ICSI), between usual care and a combined patient-centred strategy.~      Study design: A randomised controlled trial~      Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment~     in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres.~      Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The~     strategy consists of counselling through an evidence based decision aid and reimbursement of~     a 4th cycle if couples have chosen for eSET in the first 2 cycles.~      Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes~     and cost-effectiveness of the combined strategy.~      Secondary study parameters/outcome of the study:~        -  patient knowledge~        -  patient decisional conflict~        -  patient satisfaction~        -  IVF/ICSI treatment outcome.~   "
247380|NCT00315016|"~     The purpose of this study is to determine whether eplerenone is more effective than doubling~     the dose of ACE inhibitor in reducing urinary protein (albumin) loss in diabetes mellitus~   "
247381|NCT00315003|"~     This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2-~     treatmentgroup study in children (age range: ≥6 months and <72 months [< 6 years of age])~     with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral~     suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg~     once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and~     250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin~     will also be dispensed to provide blinding for the different treatment regimens.Assessments~     and reporting of safety will be carried out at all visits.~   "
247382|NCT00314990|"~     The VITRO (Vitamins and Thrombosis) study investigated the effect of homocysteine lowering by~     daily supplementation of B-vitamins on the risk reduction of deep-vein thrombosis and~     pulmonary embolism. Patients between 20 to 80 years old with a first objectively confirmed~     proximal deep-vein thrombosis or pulmonary embolism in the absence of major risk factors and~     a homocysteine concentration above the 75th percentile of a reference group were asked to~     participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of~     patients with a homocysteine below the 75th percentile of the reference group~     (normohomocysteinemic group). After informed consent patients were randomized to daily~     multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin) or~     placebo and were followed for 2.5 years. End-points were objectively diagnosed recurrent~     deep-vein thrombosis or pulmonary embolism.~   "
247383|NCT00314977|"~     2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer~     using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or~     sequential- is however unclear. The aim of the study is to compare the efficacy and~     tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide,~     taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced~     breast cancer.~   "
247384|NCT00314964|"~     The primary purpose of this study is to determine if PD-0299685 is effective and safe in the~     treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.~   "
247386|NCT00314938|"~     This will be the first clinical study of the development of PHA-794428 in a pediatric~     population. Since differences in PK and/or PD response may occur between adult and pediatric~     subjects, it is deemed appropriate to first conduct an exploratory single dose study in~     pediatric patients to assess safety and tolerability in this patient population. In addition~     this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to~     be tested in repeated dose phase 2b trials in children, using PK/PD modeling~   "
247387|NCT00314925|"~     The primary purpose of the study is to determine if Seneca Valley Virus may be administered~     safely to patients with certain types of advanced cancer.~   "
247388|NCT00314912|"~     The purpose of this Phase III open-label extension study is to evaluate the long-term safety~     of Tramiprosate (3APS) in patients with mild to moderate Alzheimer’s disease.~   "
247389|NCT00314899|"~     The purpose of this study is to find out what effect malaria in the mother has on the~     development of her child's immune system response to malaria and whether being exposed to~     malaria in the womb makes a child more likely to get malaria. The study will also assess the~     effect that exposure to malaria in the womb has on the child's growth and development over~     the first three years of life. Study participants will include 480 healthy pregnant women~     (greater than or equal to 15 years of age), their healthy offspring, 20 healthy people from~     the United States with no malaria exposure or disease and 40 adult Kenyans who have~     previously been exposed to malaria or have malaria with no signs of infection. Study~     procedures will include an ultrasound (procedure to assess the baby's growth and development~     in the womb), blood, urine, and stool collections. Newborns will be examined at birth, and at~     6, 12, 18, 24, 30 and 36 months of age.~   "
247390|NCT00314886|"~     Despite there being no clearcut advantages, one of the most common recommendations in IBS~     management is to increase the amount of dietary fibres. In some IBS patients fibres have a~     deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic~     sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal~     sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.~   "
247391|NCT00314873|"~     This study is important to demonstrate if single agent activity is noted for patients with~     thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens~     the door to evaluate other combination of drugs with imatinib in thymic tumors.~   "
247392|NCT00314860|"~     Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with~     extended release ropinirole over 12 weeks~   "
247393|NCT00314847|"~     Cardiogenic shock is currently the main cause of death after myocardial infarction and 50% of~     deaths occur within the first 48 hours. To limit the extent of the myocardial necrosis is the~     primary objective of the treatment in this context. The symptomatic treatment of the~     ventricular failure alone does not allow a reduction of mortality. The immediate prognosis is~     not significantly improved by the current standard of care, including early revascularisation~     and intra-aortic balloon counterpulsation.~      In order to improve the immediate prognosis, it seems necessary to limit the irreversible~     myocardial lesions and the systemic inflammatory response induced by an extended myocardial~     infarction (complement activation, cytokines production, iNOS expression, etc.). These~     objectives may be reached by a more extended utilization and availability of circulatory~     assistance methods.~      The investigators propose to compare, in a randomised multicenter study, two treatments of~     the myocardial infarction with cardiogenic shock among 44 patients:~      Standard Treatment versus ECLS-Impella +/- standard treatment.~      In June 2007, an amendment replaced the device ECMO by the use of Impella intra-thoracic~     pump.~      This amendment has been approved by the Ethic Committee on July 7, 2007. In March 2009, a new~     amendment has been approved by the EC. This amendment allowed to revise the number of~     patients to enroll (reduced to 44) and this lead us to modify also the primary endpoint :~     variation of BNP levels between H0 and H24 (H0 defined as the nearest value of BNP level~     obtained before the randomization).Showing a more important BNP levels decrease in the~     experimental group compared to standard treatment group, the investigators obtain an indirect~     argument to show a superior efficacy of the tested strategy.~   "
247394|NCT00314834|"~     IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to~     evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional~     status, dialysis efficacy, Karnofsky score~   "
247395|NCT00314821|"~     To demonstrate efficacy and safety of Requip in in treating bipolar depression.~   "
247396|NCT00314808|"~     This study seeks to define the tolerability and safety associated with the administration of~     Dronabinol in the treatment of adults with nausea, vomiting and appetite loss in patients~     with primary gliomas who are undergoing chemotherapy treatment. The study will also describe~     the effect of Dronabinol on the quality of life in terms of nausea, vomiting and anorexia in~     this patient group.~   "
247397|NCT00314795|"~     The purpose of this study is to evaluate the ability of peginesatide to increase and maintain~     increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on~     dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal~     transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).~   "
247398|NCT00314782|"~     Two-part, multi-center study design to establish a maximum tolerated dose (MTD) of ZD4054 in~     combination with docetaxel and to explore its safety, tolerability, pharmacokinetic (PK)~     profiles and clinical efficacy in patients with metastatic hormone-refractory prostate cancer~     (HRPC)~   "
247416|NCT00314548|"~     Summary of the proposed research:~      The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been~     used to cause a decrease not only of the pulmonary but also of the systemic vascular tone.~     Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary~     vasodilatation without affecting the systemic blood pressure as shown in preliminary~     studies/case reports. No large trials exist for this type of use of the drug so far.~     Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical~     settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress~     syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to~     ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry~     out a prospective, double blinded, randomized trial to show that the nebulized iloprost~     decreases pulmonary hypertension selectively and improves oxygenation in ARDS.~   "
247399|NCT00314769|"~     This study will examine whether continuous use of transcranial direct current stimulation~     (tDCS) in combination with motor training can lead to long-term improvement in movement~     performance beyond what can be achieved with motor training alone.~      Healthy normal volunteers 18-80 years of age who are clearly right- or left-handed may be~     eligible for this study. Each candidate is screened with a medical history, clinical and~     neurological examination, questionnaires to evaluate memory, attention, and handedness and a~     brain MRI, if one has not been done by NINDS within 12 months of entering the study. Pregnant~     women may not participate.~      The study involves 10 sessions (in addition to the screening visit) over 3 months. Sessions~     1-5 are completed over 5 consecutive days. Sessions 6-10 are divided over the remaining time.~     Participants are randomly assigned to one of three groups: 1) tDCS during motor training; 2)~     tDCS after training; or 3) training with sham tDCS. During these sessions, participants~     perform a pinch force task (squeezing a small device between the thumb and forefinger) and~     visuomotor tasks (using a device to move the cursor on a computer screen to various targets~     and holding the cursor in place for 1 second).~      During the motor training and performance sessions, participants have the following~     procedures.~        -  TMS measurements: A wire coil is held on the scalp, and a brief electrical current is~          passed through the coil, creating a magnetic pulse that stimulates the brain. During the~          stimulation, the subject may be asked to tense certain muscles slightly or perform other~          simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg,~          and the subject may hear a click and feel a pulling sensation on the skin under the~          coil.~        -  tDCS: Small, wet sponge electrodes are applied to the head - one above the eye and the~          other on the back of the head. A small electrical current is passed between them. The~          subject may feel an itching or tingling sensation under the electrodes or see light~          flashes. Some sessions are done with sham tDCS.~        -  Surface electromyography: Electrodes are filled with a conductive gel and taped to the~          skin over one small hand muscle to measure the electrical activity of muscles.~        -  Behavioral measurements: Evaluation of learned movement tasks~        -  Questionnaires to evaluate the subject's attention, fatigue and mood before and after~          testing~   "
247400|NCT00314756|"~     To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after~     initial treatment with curettage~   "
247401|NCT00314743|"~     The purpose of this study is to determine the efficacy of aprepitant in preventing acute and~     delayed chemotherapy induced nausea and vomiting when administered in combination with~     intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous~     transplant setting.~   "
247402|NCT00314730|"~     This study evaluates the usability of personal digital assistants (PDAs) by nurses for~     collecting, utilizing and communicating patient health information, and the feasibility of~     using PDAs to increase nurses' access to and utilization of best-practice guidelines.~   "
247403|NCT00314717|"~     The purpose of the study is to see if a low glycemic index diet will reduce blood sugar~     levels in pregnant women with high blood sugar levels.~   "
247404|NCT00314704|"~     The purpose of this study is to compare the efficacy of dopamine and norepinephrine, two~     commonly used vasopressor agents, in the treatment of shock.~   "
247405|NCT00314691|"~     After extraction of the cell-free DNA circulating in maternal plasma, we aim at developing~     new techniques for fetal DNA enrichment to perform fetal gender determination, and indirect~     diagnosis of inherited diseases like Cystic Fibrosis, Huntington Disease, Myotonic Dystrophy,~     B-Thalassaemia...~   "
247406|NCT00314678|"~     Clinically, there has been extensive experience with topotecan and cisplatin. Recently,~     several investigators have evaluated the combination of paclitaxel, cisplatin and topotecan.~     As expected, myelosuppression was the dose-limiting factor. Herben et al recently reported~     the results of a phase I trial using the combination of paclitaxel, cisplatin, and topotecan~     as first line therapy in advanced stage ovarian cancer. Interestingly, the authors could not~     achieve a dose of topotecan that would be considered optimal for the treatment of relapsed~     disease in a single-agent fashion. The inability to utilize a therapeutic dose when combined~     with either platinum or paclitaxel has been demonstrated in previous reports and affirms the~     bone marrow suppressive effect. The clinical response rate from this trial was reported as~     86.7%.~   "
247407|NCT00314665|"~     This research study is for patients that have been diagnosed with chronic uveitis, a disease~     that causes inflammation in the eye. Patients are currently being treated with Remicade,~     Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation.~     Despite these medications, patients still have inflammation in their eyes. Patients are being~     asked to add an additional drug, thalidomide.~   "
247408|NCT00314652|"~     The objective of this study is to assess the safety and efficacy of the buprenorphine~     transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects~     with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.~   "
247409|NCT00314639|"~     Patients suffering from schizophrenia and schizophrenia spectrum psychosis frequently~     experience cognitive impairments. Such deficits may affect memory, attention and executive~     function processes. Many studies have shown that cognitive impairments predict daily~     functioning. Improvement of these difficulties represents a major component of recovery in~     such population. Second generation antipsychotics, now first line intervention, have been~     shown to improve cognitive processes compared to first generation agents. However, more~     subtle cognitive impairments may still remain. In fact, cognitive impairments is one of the~     most frequent subjective complaints from patients and their family, even though antipsychotic~     treatment has been optimized. Very few options are available to clinicians to try to improve~     such persistent cognitive difficulties. First, cognitive remediation techniques have shown~     some effectiveness but results are sparse and come from a very small number of studies. It is~     also not clear if cognitive improvement obtained from such techniques would apply to daily~     functioning and can be generalized.A second possible intervention would be to add a~     pharmacological agent able to improve cognition. Modafinil (Alertec) is officially indicated~     for improving wakefulness in patients with excessive daytime sleepiness associated with~     narcolepsy. Some empirical data and clinical observations suggest that modafinil could~     improve alertness and/or cognitive functioning without exacerbating psychotic features in~     persons with schizophrenia and psychotic disease in the spectrum of schizophrenia. This study~     aims to (a) assess the effect on cognitive functioning of modafinil as an adjunctive to a~     second generation antipsychotic in a prospective cohort of thirty patients suffering from~     schizophrenia and psychosis in the spectrum of schizophrenia. This study will also (b)~     evaluate the impacts of the addition of modafinil on side effects, psychopathology symptoms~     and other health parameters (such as weight, metabolic profile, etc.). Our principal~     hypothesis is that significant improvements will be observed on attention processes without~     any exacerbation of psychotic symptoms or major emerging side effects. This cross-over~     placebo-controlled prospective study will include patients with schizophrenia or psychosis in~     the schizophrenia spectrum according to DSM IV definition, men or women aged over 18 years~     old, with no item score equal or over 5 at PANSS positive symptoms subscale. At enrollment,~     all patients will have to experience significant cognitive difficulties with scores equal or~     lower than Z=-1.00 at Color trail test, Mesulam and Weintraub Cancellation Test, Stroop test~     or Continuous Performance Test-II. Patients will be exposed to 100mg daily of Placebo or~     Modafinil for 2 weeks than to 200mg daily for the two following weeks. A two weeks wash out~     period will then take place before the same sequence will be start again. Patient will thus~     be exposed one month to placebo and one month to modafinil or conversely, in a random~     fashion.Assessments will include neurocognitive standardized battery, psychopathological~     tools (PANSS, CGI, SOFAS, SDS), side effects (UKU, ESRS, DAI), vital signs, anthropometric~     and metabolic profile.~   "
247410|NCT00314626|"~     To evaluate the proportion of patients with virological failure after 48 weeks of treatment~     with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once~     daily as an antiretroviral simplification regimen.~   "
247411|NCT00314613|"~     Assured treatment with Risperal CONSTA will provide first-episode patients, who have a~     greater potential for therapeutic response, with their best opportunity for continued~     improvement in cognitive function beyond three months of treatment.~   "
247412|NCT00314600|"~     The investigators created a randomized clinical trial to find out what kind of treatment is~     optimal for non-dislocated both-bone midshaft forearm fractures.~   "
247413|NCT00314587|"~     The investigators created a randomized clinical trial between 1 or 2 elastic stable~     intramedullary nails to find out what kind of treatment is optimal for unstable both-bone~     midshaft forearm fractures.~   "
247414|NCT00314574|"~     This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy,~     safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the~     treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are~     inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting~     beta-agonists (LABA) with or without additional controller therapy.~   "
247415|NCT00314561|"~     Pioglitazone and rosiglitazone are used in the treatment of diabetic patients.~     Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose~     levels and lipid profiles. The effect of these two different thiazolidinediones on~     atherosclerotic and inflammatory markers has not been compared in prospective manner. The~     purpose of this prospective, randomized, open-label, crossover trial is to compare the effect~     of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients~     with metabolic syndrome.~   "
247417|NCT00314535|"~     Magnetic resonance (MR) spectroscopic techniques are to be developed to obtain the best data~     possible at 3 Tesla (3T) for the prostate.~   "
247418|NCT00314522|"~     This study performed a retrospective analysis of patient images to develop software in~     determining dose delivered for each fraction treatment.~   "
247419|NCT00314509|"~     The aim of the study is to compare the efficacy of two doses of a fixed combination of~     ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in~     patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a~     treatment period (8 weeks). The study will provide further data on safety and tolerability of~     ciclesonide/formoterol fumarate.~   "
247420|NCT00314496|"~     Retrospectively have access to MR images of patients to develop software that:~        1. segment images~        2. convert MR values to electron density and then~        3. entered into a dose calculation system~      The project involves software development of data that is already available. No intervention~     is made at this point.~   "
247421|NCT00314483|"~     Mesenchymal stem cells (MSC) have been shown to have immunosuppressive properties. Following~     a bone marrow/peripheral blood stem cell transplant, a proportion of patients develop a~     condition called ‘graft versus host disease’ (GVHD). In this condition the transplanted cells~     recognize the recipient as foreign and bring about an immune-mediated destruction of tissues.~     The treatment for this condition is to use drugs that will cause immunosuppression. A small~     subset of these patients develop a severe form of GVHD (Grade III or IV) which, in spite of~     the best currently available treatment, is associated with eventual death in more than 90% of~     cases. The investigators propose to use infusions of expanded MSC from the donor to treat~     this condition. A few reports on this approach have already been published in peer reviewed~     journals and preliminary results appear to be promising. The investigators are also aware~     that larger trials have been initiated to study this. After getting written informed consent,~     the investigators will infuse expanded MSC into patients who develop steroid-resistant GVHD.~   "
247422|NCT00314470|"~     The purpose of this study is to retrospectively have access to image files of patients.~   "
247423|NCT00314457|"~     The aim of this study is to determine whether the continuous intraarticular infusion of local~     anesthetics in the postoperative period can improve analgesia and patients satisfaction after~     knee and shoulder arthroscopy.~   "
247424|NCT00314444|"~     This study will examine whether biofeedback treatment is effective in lessening or stopping~     movement symptoms in people with psychogenic movement disorder. People with this condition~     have increased or decreased movements that are not under their control and are not associated~     with any know problem with the nervous system. Biofeedback is a type of therapy that uses~     electronic instruments to monitor breathing and heart rate. This treatment has been effective~     in patients with anxiety and panic attacks.~      People 18 years of age and older diagnosed with psychogenic movement disorder may be eligible~     for this study. Candidates are screened with a neurological history, physical examination and~     psychiatric evaluation.~      Participants come to the NIH Clinical Center for nine 1-hour test sessions over an 8-week~     period for the following procedures:~      Week 1 (two visits):~        -  Patients' movements are videotaped while they sit, stand and walk.~        -  Patients train on RESPeRATE device, a computerized musical biofeedback device to help~          slow theirs breathing rate. The device has three components: a computerized module,~          earphones, and a chest strap holding a breath sensor. The patients put the elastic strap~          around their chest, put on the earphones, and sit in a chair. The device monitors and~          analyzes their breathing to create a melody composed of two distinct tones - one for~          inhalation and one for exhalation. Patients are instructed to match their breathing to~          the tones, which gradually slow until they are breathing at a slower, therapeutic rate.~        -  Patients' breathing is monitored and analyzed for information on breathing pattern and~          rate.~        -  Patients complete questionnaires on level of relaxation before and after RESPeRATE~          training.~        -  Patients take the RESPeRATE device home to use for two 10-minute practice sessions per~          day. They complete relaxation questionnaires before and after each session.~      Weeks 2-7:~        -  Patients' progress is monitored and reviewed from the previous week~        -  Patients' breathing is monitored and analyzed for information on breathing pattern and~          rate.~        -  Patients complete questionnaires on level of relaxation before and after RESPeRATE~          training.~        -  Patients are observed for 10 minutes while using the RESPeRATE device.~      Week 8:~        -  Patients' progress is monitored and reviewed from the previous week~        -  Patients' breathing is monitored and analyzed for information on breathing pattern and~          rate.~        -  Patients complete questionnaires on level o...~   "
247425|NCT00314431|"~     Based on success with telephone follow up for other groups of medically fragile infants, we~     designed an innovative model of post-hospital comprehensive and coordinated follow-up for~     infants with chronic lung disease. In this model, which we refer to as community-based~     follow-up, medical management was coordinated by a nurse specialist, through frequent~     telephone contacts with the infants' primary caregiver. This model of follow up care was~     compared, in a randomized trial, with the more traditional model - multidisciplinary medical~     center-based care. We hypothesized that community-based care would lead to health and~     developmental outcomes similar to those observed with center-based care.~   "
247426|NCT00314418|"~     Colonoscopy is usually associated with coiling (looping) of the colonoscope (instrument~     used for the procedure) in parts of the bowel. This is the main reason for patient discomfort~     and lengthens the duration of the procedure. Minimizing the coiling of the colonoscope would~     decrease the duration, and improve the efficiency and tolerability of the procedure and have~     a positive impact on colon cancer screening.~      The primary aim of this study is to compare the time it takes for the colonoscope to reach~     the end of the colon when the patient is lying on the belly versus the left side (usual) at~     the start of the procedure. Patients who have medical conditions that may be affected by~     lying on their belly or those who cannot comfortably lie on the belly will be excluded from~     the study. Changes in patient position and use of abdominal pressure (commonly given by the~     endoscopy nurse during the procedure) will be permitted as necessary and determined by the~     endoscopist. The endoscopist will also retain the decision to discontinue the patient's~     participation from the study for any medical reason. After the procedure the patient will be~     monitored in the usual manner and asked to fill out a satisfaction survey (24 hours after).~   "
247427|NCT00314405|"~     The aim of this study is to evaluate the performance of a double labelling method using~     isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a~     series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and~     patients: SLN excision will be performed on 100 patients treated for infiltrative breast~     cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual~     localization of the radioactive and stained nodes will be performed. After the surgery, SLN~     will be submitted to serial analysis and immunohistochemistry. A comparison of the two~     methods and an economical evaluation of the complete procedure will be performed.~   "
247428|NCT00314392|"~     The response to standard pain stimuli in males and females is investigated, together with the~     effect of informing participants about the effect of a painkiller. Physiological response to~     pain is recorded.~   "
247429|NCT00314379|"~     The ICARE study, clinicaltrials.gov ID number: NCT00220831 and protocol number KL-2004, is~     recruiting diabetic patients with haptoglobin phenotype 2-2, which are randomised to either~     Vitamin E 400IU per day or placebo. Patients will be followed for 4 years for the major~     cardiovascular complications of diabetes, acute myocardial infarction (MI), stroke and~     cardiovascular mortality (see ICARE protocol). The EFI study, Endothelial Function in ICARE~     will recruit a sample group of 50 patients from the ICARE cohort. These patients will~     complete all requirements by ICARE protocol and in addition will be tested for endothelial~     function by a non-invasive method of flow mediated dilatation (FMD).~   "
247430|NCT00314366|"~     Recent studies have suggested that it may be possible to grow new blood vessels~     (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One~     theory is that a certain type of stem cell, aldehyde dehydrogenase bright stem cells, may~     stimulate the growth of new vessels. After a bone marrow procedure, the special cells are~     separated and then injected back into the heart around the area of damage with a special~     guidance and injection system.~      Once a patient meets all inclusion criteria and no exclusion criteria, he/she will be~     consented to the study and extensive baseline testing will be completed at St. Luke's~     Episcopal Hospital in Houston, Texas. Once all baseline criteria are met, the patient has~     his/her own bone marrow harvested and later injected, if randomized to receive active~     treatment. The day after the bone marrow harvest, the patient is taken to the cardiac~     catheterization lab where NOGA mapping is performed and the processed cells or placebo are~     injected under electromechanical guidance into the affected areas of the left ventricle. The~     patient is usually discharged home the next day and returns for follow-up at weeks 1 and 4,~     and months 3 and 6, and at one year unless there is a crossover and then he/she begins~     baseline again at 6 months and follow-up for one more year. Follow-up testing, including~     quality of life and NOGA mapping, is done at the time of injection, as well as at 6 months.~   "
247431|NCT00314353|"~     Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation~     in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to~     kill cancer cells directly. This study is being done to see how colorectal cancer responds to~     treatment with the combination of bevacizumab and chemotherapy.~   "
247432|NCT00314340|"~     Characterize the relative abuse liability of a short versus a long acting opioid in chronic~     pain patients.~   "
247433|NCT00314327|"~     The purpose of this project is to evaluate the efficacy of long-acting risperidone for~     patients with first episode schizophrenia spectrum who did not improve sufficiently with the~     first antipsychotic medication they tried during their initial treatment trial.~   "
247434|NCT00314314|"~     It is hypothesized that the intranasal administration of insulin will enhance~     hippocampal-dependent neurocognitive performance in euthymic patients with bipolar I or II~     disorder. This novel initiative represents a proof-of-concept study that insulin is salient~     to neurocognitive functioning and deficits in bipolar disorder and represents a novel and~     safe therapeutic avenue. The available literature suggests that the acute administration of~     intranasal insulin enhances cognition in memory impaired older adults with either Alzheimer's~     disease or minimal cognitive impairment. Prior research demonstrates a cognitive enhancing~     effect of insulin within one hour of the first intranasal insulin dose. Other studies suggest~     that the long-term administration of intranasal insulin (i.e. over eight weeks) in enhances~     memory performance in human volunteers. We aim to evaluate the acute and long-term effects of~     intranasal insulin administration in persons with bipolar disorder. As such we will be~     conducting the neuropsychological testing at three time points, the week before receiving~     insulin, within one hour of the first dose and after 8 weeks of insulin administration.~   "
247435|NCT00314301|"~     The purpose of this study is to compare movement variations before and after the loaded~     training, with kinematics, kinetics, and electromyography, in children with spastic diplegia~     and to further discuss mechanisms of the loaded training.~   "
247436|NCT00314288|"~     The primary purpose of the study is to investigate the anti-dyskinetic effect of several~     doses of sarizotan in Parkinson patients in order to generate information on the~     dose-response relationship (dose-finding).~   "
247437|NCT00314275|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) and safety associated with~     ABT-578 administered using the Medtronic Endeavor Drug Eluting Coronary Stent system in the~     treatment of single de novo lesions in native coronary arteries between 2.5 - 3.5 mm in~     diameter.~   "
247438|NCT00314262|"~     Evaluate effect on cells and patient response to study medications, assess side effects of~     these medications, and evaluate chemicals in cells that may tell how the drug works, before,~     and after receiving the study medications.~   "
247439|NCT00314249|"~     The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a~     dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with~     fibromyalgia.~   "
247440|NCT00314236|"~     This study will investigate whether the treatment of damaged cartilage in the knee with~     BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with~     microfracture alone. Furthermore, the effect of BST-CarGel in decreasing cartilage related~     pain and improving cartilage-related function in the knee will be assessed.~   "
247441|NCT00314223|"~     Background: Sinus node dysfunction is a major cause of bradycardia necessitating pacemaker~     implantation. Evidences of genetic study supported that some genes involved in the pacemaker~     current or renin-angiotensin system were related to sinus node dysfunction. However, the~     influence of gene polymorphisms on sinus node dysfunction was not well studied.~      Methods: A group of 100 patients with documented sinus node dysfunction and 100 age- and sex-~     matched healthy control patients will be enrolled into this study. Gene polymorphism study~     includes the angiotensin-I converting enzyme gene, angiotensin II type 1 receptor gene,~     HCN1-4, SCN5A, KCNE and other possible gene polymorphisms which are related to sinus node~     function based on previous reports. Genetic polymorphisms are identified with polymerase~     chain reaction-based restriction analysis. Comparison of multiple haplotype analysis and~     single-locus analysis will be analyzed between the cases and controls.~      Estimated Results: Some genetic polymorphisms of these genes which are related to sinus node~     function or rennin-angiotensin system will show association with sinus node dysfunction. In~     multilocus haplotype analysis, some genetic haplotype profiles may demonstrate significant~     difference between cases and controls. In single locus analysis, some genetic polymorphisms~     may be associated with sinus node dysfunction.~      Estimated Conclusion and Clinical Implication: This study will demonstrate the genetic~     polymorphisms in RAS genes or some other genes associated with sinus node dysfunction. These~     results will support the roles of these genetic polymorphisms in determining the risk of~     sinus node dysfunction among the Chinese population in Taiwan.~   "
247442|NCT00314210|"~     The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to~     placebo in increasing time from randomisation to an anxiety event in patients with~     generalised anxiety disorder (GAD).~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
247443|NCT00314197|"~     The investigators propose to conduct a randomized controlled trial at the patient level of~     the Telephone Linked Care - Behavioral Change (TLC-BC) system, which is designed to promote~     smoking cessation, reduce risky drinking, and improve physical activity and diet. They expect~     to:~        1. successfully integrate an automated telephone behavior change intervention into primary~          care practices;~        2. demonstrate improvement in health behaviors for individuals randomized (assigned by~          systematic chance) to use the TLC-BC system compared to individuals who receive written~          health education informational packets; and~        3. evaluate the direct costs associated with the use and operation of the TLC-BC system.~      Project aims and hypotheses follow:~      Aim 1: Integrate a proven, totally automated computer telephone intervention, Telephone~     Linked Care - Behavior Change (TLC-BC), into primary care practices. This will be assessed by~     the patient and clinician/staff surveys at the end of data collection.~      Aim 2: Demonstrate an improvement in health behaviors for individuals randomized to use the~     TLC-BC system compared to individuals who receive written informational packets.~      Aim 3: Evaluate the direct costs associated with the use and operation of the TLC-BC system~     within the primary care setting.~      Hypothesis 1: The Telephone Linked Care - Behavioral Change system will be successfully~     implemented by patients and practices.~      Hypothesis 2: At 6 months a clinically significant improvement in behavioral change rates~     will be demonstrated for diet, physical activity, and smoking in the intervention group~     compared to patients in the control group.~      Hypothesis 3: At baseline, 3, 6, and 9 months risky drinking will be identified, but there~     will be no difference in improvement between the study groups.~   "
247444|NCT00314184|"~     This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to~     evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up~     to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
247445|NCT00314171|"~     The purpose of this study is to determine whether a glaucoma therapy is safe and effective in~     treating patients with open-angle glaucoma or ocular hypertension.~   "
247446|NCT00314158|"~     The purpose of this study is to determine whether a glaucoma therapy is safe and effective in~     treating patients with open-angle glaucoma or ocular hypertension.~   "
247447|NCT00314145|"~     The purpose of this study is to determine non-inferiority in seroconversion and to compare~     the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous~     virus strain after completion of vaccination course.~   "
247448|NCT00314132|"~     The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be~     used for vaccination against Japanese encephalitis) is safe and well tolerated when compared~     to placebo (dummy) vaccination.~   "
247449|NCT00314119|"~     This study will explore the growth of dermal neurofibromas (skin tumors) in patients with~     neurofibromatosis type 1 (NF1). Investigators will try to learn: 1) how fast (or slow) these~     benign tumors grow in NF1, 2) how often new tumors appear and 3) what genes are involved in~     the growth of the tumors.~      Men and women between 20 and 50 years of age diagnosed with NF1 and their biological parents~     are eligible for this study.~      Patients with NF1 are evaluated at the NIH Clinical Center with the following tests and~     procedures:~        -  Medical examination and drawing of family tree.~        -  Photos of the back, abdomen and thigh in order to count the number of skin tumors.~        -  Photos of the skin taken with a special camera (Primos camera) that takes very detailed~          pictures of a small area of skin.~        -  Photos of the skin taken with a dermatoscope, which takes very detailed pictures of a~          small area of skin under high magnification.~        -  Biopsy of at least one skin tumor and biopsy of a small piece of normal skin.~        -  Blood sample collection for genetic testing of the gene NF1 and to establish a cell~          line.~        -  Other medical tests (e.g., x-rays or MRI) if needed.~      Patients and their families will also have a genetic counseling session and an opportunity to~     ask questions about neurofibromatosis type 1.~      Patients return to the NIH after 3, 6, 12, 18 and 24 months for follow-up photographs and~     possibly blood samples.~      Biological parents of patients provide a blood sample for genetic testing.~   "
247450|NCT00314106|"~     Background:~        -  In a study in humans with melanoma, patients given total body irradiation to suppress~          the immune system in conjunction with chemotherapy showed a significant clinical~          response.~        -  In previous studies, about one-half of patients given tumor-fighting cells (cells~          created from the patient's tumor cells and grown in the laboratory) showed some~          anti-tumor response.~      Objective: To determine whether tumor-fighting cells taken from a melanoma tumor and grown in~     the lab can more effectively at fight melanoma when the patient's immune system is suppressed~     and cannot attack them.~      Eligibility: Patients 18 years of age or older with metastatic melanoma who have tumor~     reactive cells available.~      Design:~      -Patients are assigned to one of two groups - those having received prior therapy with~     Interleukin-2 (IL-2) and those who have not.~      After five days of injections of filgrastim, a medicine to stimulated the growth of white~     blood cells, patients undergo apheresis or bone marrow harvesting, or both, to collect stem~     cells for later re-infusion. For apheresis, whole blood is collected through a needle in an~     arm vein and circulated through a cell-separating machine where the stem cells are extracted.~     The rest of the blood is returned through the same needle or a needle in the other arm. Bone~     marrow harvesting is done under general anesthesia. Stem cells are collected through a large~     needle inserted into the hipbone.-Patients' immune system cells and bone marrow function are~     eliminated with chemotherapy (7 days) and total body irradiation (3 days) so the patient's~     immune system cells will not fight the tumor-fighting cells they are given in treatment.~        -  1 to 3 days after total body irradiation, patients receive the tumor-fighting cells by~          intravenous (IV) infusion. After the cells are infused, they receive interleukin-2~          (IL-2) infusions every 8 hours for 5 days.~        -  2 days after infusion of the tumor-fighting cells, patients receive the stem cells~          collected earlier by apheresis.~        -  Patients are evaluated 4 to 6 weeks after cell infusion to look for tumor response to~          treatment. Patients whose tumor has not grown return to the National Institutes of~          Health (NIH) every 1 to 3 months for blood tests, scans and x-rays.~   "
247451|NCT00314093|"~     Background:~        -  CD4+ cells are white blood cells that regulate the immune system by controlling the~          strength and quality of the immune response.~        -  CD25+ cells are a subset of CD4+ cells that suppress or prevent immune responses.~        -  RFT-5-dgA is an immunotoxin (substance that kills specific cells in the immune system)~          that kills CD25+ cells.~        -  In mouse studies, RFT-5-dgA showed anti-tumor activity in animals studies.~      Objective: To determine whether the immune system of patients with metastatic melanoma~     (melanoma that has spread beyond the original site) can cause tumors to shrink if the~     patients are given RFT-5-dgA to remove their CD25+ cells.~      Eligibility: Patients 18 years of age and older with metastatic melanoma whose disease has~     progressed after receiving standard treatment.~      Design:~        -  Patients receive RFT-5-dgA through a vein every other day for a total of 3 doses (one~          treatment course). Patients have routine blood tests during the week of treatment.~        -  Four to 5 weeks after the last dose, patients are evaluated with a physical examination,~          blood tests and scans and x-rays to evaluate their tumor.~        -  Patients whose tumor has shrunk or remained stable may be offered additional treatment~          with RFT-5-dgA up to a total of four courses.~        -  Patients undergo leukapheresis or have several tubes of blood drawn from a vein to~          determine the effects of RFT-5-dgA on the immune system. This is done before the first~          dose of RFT-5-dgA, after the first three doses, and possibly during subsequent treatment~          courses in those patients who receive additional treatment. For leukapheresis, blood is~          collected through a needle in an arm vein and flows through a catheter into a machine~          that separates it into its components by spinning. The white cells are extracted and the~          rest of the blood is returned through another needle in the other arm.~   "
247452|NCT00314080|"~     Background. Northern Thailand's biggest botulism outbreak to date occurred on 14 March 2006~     and affected 209 people. Of these, 42 developed respiratory failure, and 25 of those who~     developed respiratory failure were referred to 9 high facility hospitals for treatment of~     severe respiratory failure and autonomic nervous system involvement. Among these patients, we~     aimed to assess the relationship between the rate of ventilator dependence and the occurrence~     of treatment by day 4 versus day 6 after exposure to bamboo shoots (the source of the~     botulism outbreak), as well as the relationship between ventilator dependence and negative~     inspiratory pressure.~      Methods. The investigators reviewed the circumstances and timing of symptoms following~     exposure. Mobile teams treated patients with botulinum antitoxin on day 4 or day 6 after~     exposure in Nan Hospital (Nan, Thailand). Eighteen patients (in 7 high facility hospitals)~     with severe respiratory failure received a low- and high-rate repetitive nerve stimulation~     test, and negative inspiratory pressure was measured.~   "
247453|NCT00314067|"~     The purpose of this study is to disseminate and transfer the comprehensive quality management~     interventions (CQM) for alcohol-related disorders in primary care developed during the first~     funding phase into routine care. The two steps are (1) to optimize the CQM approach and (2)~     to investigate the dissemination and transfer into routine care in a randomized controlled~     trial.~   "
247454|NCT00314054|"~     The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with~     chronic hepatic impairment and in matched healthy adults.~   "
247455|NCT00314041|"~     Infant phase: To determine the safety of and production of antibodies by a group C~     meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine~     vaccines.~      Booster phase: To compare the safety of and production of antibodies by MnCC with and without~     MMR and to compare the antibody response to that produced by a low dose of plain~     polysaccharide vaccine as a way of investigating immune memory~   "
247456|NCT00314028|"~     This study will test the effectiveness of a brief clinic-based program designed to promote~     the correct use of condoms among young African-American men newly diagnosed with a sexually~     transmitted disease.~   "
247457|NCT00314015|"~     Evaluation of the success rate of immediately loaded implants based on:~        -  condition of the gingiva~        -  stability of the implants~        -  evaluation of the RXs~        -  questionnaires~   "
247458|NCT00314002|"~     Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With~     Massive Pulmonary Embolism~      Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for~     mechanical thrombectomy with Aspirex 11F.~      Treatment: Aspirex 11F assisted thrombectomy~      _________~      The study was terminated early. After having treated seven (7) patients, it was decided in~     April 2007 that the handling characteristics of the test device should be upgraded before~     continuing the trial as planned. Therefore, the study was long-term interrupted and finally~     terminated early. This decision was made by the sponsor in full accordance with the principal~     investigator. Further studies shall be conducted to show effectiveness and safety of the~     Aspirex PE catheter thrombectomy device.~      _________~      Primary Endpoints:~        1. Thrombectomy with the Aspirex catheter device is associated with an immediate decrease~          in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP).~        2. The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and~          untreated cardiovascular structures.~      Secondary Endpoints:~        1. Thrombectomy with the Aspirex catheter device is associated with improved flow in the~          treated main and lobar pulmonary arteries as assessed by the angiographic Miller index.~        2. There will be no significant mechanical haemolysis as assessed by plasma free~          haemoglobin levels.~        3. In-hospital mortality will not exceed 20%.~      Study Design: A prospective international multicenter non-randomized registry assessing the~     safety and efficacy of the Aspirex 11F mechanical thrombectomy device.~      Sample Size: Maximum of 50 patients~      Inclusion Criteria:~        -  Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis~          or at least contraindication for lysis.~      Exclusion Criteria:~        -  Systemic embolism in the presence of an arterial septal defect or patent foramen ovale.~        -  Free floating right heart thrombi, left heart thrombi.~        -  Life expectancy, due to underlying disease, less than one month.~   "
247459|NCT00313989|"~     Follow up of implants with patients receiving radiotherapy for buccopharyngeal oncology.~     Implants will be placed 6 weeks before start of the radiotherapy or at least 3 months after~     the end of the radiotherapy~   "
247460|NCT00313976|"~     The purpose of the study is to evaluate if the higher dose can give greater efficacy without~     negative impact on the adverse event profile for patients with early secondary progressive~     Multiple Sclerosis (SPMS).~   "
247461|NCT00313963|"~     The purpose of this study is to determine if intravenous magnesium sulfate treatment is~     effective in reducing the length of stay and pain in children with sickle cell disease~     suffering an acute vaso-occlusive episode.~   "
247462|NCT00313950|"~     The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months~     Turkish children and check if the administration of the MMR trivalent vaccine on the same day~     but at different site will interfere on immunogenicity for the four valences Hepatitis A,~     Measles, Mumps, and Rubella.~   "
247463|NCT00313937|"~     Primary objective:~      To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am~     - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during treatment~     with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00~     am between patients on Insulin glargine and NPH insulin.~      Secondary objective:~      To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as~     well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).~   "
247464|NCT00313924|"~     OAB is a widespread medical problem affecting 6- 30% of the population (both sexes and all~     age groups) in Europe1 and 16%2-18%3 of the US and Canadian population. Nevertheless only a~     small proportion of this group turns to seek medical help. Once treated, evaluation of~     treatment outcome is problematic since outcome measures for success vary widely (i.e.~     improvement in number of incontinence episodes, number of urge episodes, change in frequency~     and nocturia etc) but do not include measures of patient reported outcomes.~      The OAB Assessment Tool is a self-administered questionnaire (8-question self–filled survey)~     primarily intended to identify patients with symptoms of OAB. The same comparable information~     could be obtained after a certain treatment period, thus providing accurate and precise~     measures of success. It could also offer insight to the changes of the different parameters~     that make up the problem. Due to its ease of administration and its high specificity in~     assessing OAB, the OAB Assessment Tool seems to be optimal for this objective.~   "
247483|NCT00313677|"~     The purpose of the study is to describe the early signs and symptoms of the~     dystroglycanopathies, and to gather information that will be required for future clinical~     trials.~   "
247598|NCT00312143|"~     This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in~     combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney~     transplant recipients.~   "
247465|NCT00313911|"~     To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence~     rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the~     three vaccinations at 2, 4, and 6 months of age for each subject.~      To evaluate the overall safety in terms of:~      Any solicited adverse reactions in the first 7 days after each injection, Any adverse events~     and reactions in the first 30 days after each injection, Any serious adverse events during~     the trial.~      Immunogenicity:~      To document the immune response to Hepatitis B antigen of the three batches of the~     investigational DTaP-IPV-HB-PRP~T vaccine.~   "
247466|NCT00313898|"~     In clinical practice it is quite common to have sexually active male patients with~     mild/normal erectile function that are not satisfied with their sexual function. The aim of~     this study is to evaluate the effect of sildenafil on the quality of sexual function in this~     group of patients.~      The endpoint of this study is to define another, different group of patients that may respond~     positively to treatment with sildenafil.~   "
247467|NCT00313885|"~     Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing~     sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances~     are associated in patients with fibromyalgia. By improving the quality of sleep, complaints~     of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this~     chronic pain disorder may be improved.~   "
247468|NCT00313872|"~     To assess the optimal sequence of the palliative chemotherapy regimen (DP --> FOLFIRI vs~     FOLFIRI --> DP) in metastatic gastric cancer patients.~   "
247469|NCT00313859|"~     This trial is designed to assess the tolerability and efficacy of simvastatin plus FOLFIRI~     (irinotecan, 5-FU, leucovorin) in metastatic colorectal cancer patients.~   "
247470|NCT00313846|"~     The objective of this study is to demonstrate the effectiveness and tolerability of the~     buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal~     system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently~     treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during~     which time supplemental analgesic medication (acetaminophen) will be provided to all subjects~     in addition to study drug.~   "
247471|NCT00313833|"~     This pilot study was designed to evaluate the effectiveness and tolerability of the~     buprenorphine transdermal system versus placebo on health outcomes in elderly residents in~     supervised living environments. The treatment intervention duration is 42 days during which~     time supplemental analgesic medication (usual analgesic care) will be provided to all~     subjects in addition to study drug.~   "
247472|NCT00313820|"~     Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with~     central post stroke pain (CPSP)~   "
247473|NCT00313807|"~     Exposure to radiographic contrast dye during coronary angiography is well known to cause~     either transient decreases in renal function or acute renal failure. Although the overall~     incidence is low, acute renal failure occurs most frequently in patients with both diabetes~     and chronic renal failure where the average reported incidence is upwards of 20%. The~     etiology of contrast-induced nephropathy is related to acute decline in renal blood flow~     following dye exposure resulting in ischemic injury at the level of the medulla. The~     development of acute renal failure following radiocontrast dye administration is significant~     because it contributes to morbidity and mortality in patients at risk.~      The administration of amino acids, either through intravenous infusion or a protein meal,~     results in a substantial increase in renal plasma flow (RPF) and glomerular filtration rate~     (GFR). In both healthy subjects and in those with chronic renal failure, an amino acid~     infusion produces a 20% rise in GFR and effective RPF.~      We hypothesize that the 20% rise in effective RPF and GFR following an amino acid infusion~     will counteract the radiocontrast dye-induced vasoconstriction and reduce the renal toxicity~     of contrast medium in a group of high-risk patients.~   "
247474|NCT00313794|"~     This study is for patients with metastatic adenocarcinoma arising from the colon or rectum~     who have received treatment(s) for metastatic disease with subsequent disease progression.~     Patients who are intolerant to treatment(s) are also included. This is a study for good~     performance status colorectal cancer patients who have exhausted standard therapy options.~   "
247475|NCT00313781|"~     To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of~     prostate cancer that is refractory to hormone therapy~   "
247476|NCT00313768|"~     To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel,~     carboplatin and bevacizumab as first-line treatment in patients with locally advanced or~     metastatic nonsquamous non-small cell lung cancer~   "
247477|NCT00313755|"~     The purpose of this study is to determine whether a new colonoscopic viewing technique called~     narrow band imaging (NBI)can help doctors detect more patients with at least one~     pre-cancerous area than conventional colonoscopy using white light alone in patients with~     genetically inherited high risk for bowel cancer (HNPCC).~   "
247478|NCT00313742|"~     This trial is conducted in Europe. The aim of this research is to assess the impact of three~     basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes~     when performing physical exercise.~   "
247479|NCT00313729|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients~     with supratentorial low-grade glioma.~   "
247480|NCT00313716|"~     The purpose of this study is to determine the effect of early administration of recombinant~     human erythropoietin on long-term neurological outcome after severe traumatic brain injury.~   "
247481|NCT00313703|"~     The purpose of this study is to determine how often headaches recur and to learn how to~     predict continued suffering from headache after emergency department discharge.~   "
247482|NCT00313690|"~     -  The purpose of the phase I portion of the study is to determine the safety and~          feasibility of neoadjuvant bortezomib in combination with docetaxel and cisplatin~          followed by surgery in early stage non-small cell lung cancer, via a multi-cohort dose~          escalation trial.~        -  The phase II portion of the study will look at the clinical response rate and the~          pathology response rate. Other purposes are to look at surgical morbidity, mortality and~          respectability rates. Molecular correlates of response and survival to this neoadjuvant~          regimen will be explored.~   "
247484|NCT00313625|"~     RATIONALE: Giving chemotherapy, such as melphalan and busulfan, before a donor peripheral~     blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving tacrolimus~     and methotrexate before or after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving melphalan together with busulfan~     followed by donor peripheral stem cell transplant, tacrolimus, and methotrexate works in~     treating patients with multiple myeloma.~   "
247485|NCT00313612|"~     This phase II trial is studying how well giving oxaliplatin together with topotecan works in~     treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian~     tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~   "
247486|NCT00313599|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Lapatinib may help paclitaxel work better by making tumor cells more sensitive to the drug.~     Lapatinib may also stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Giving lapatinib together with paclitaxel may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when~     given together with paclitaxel in treating patients with advanced solid tumors.~   "
247487|NCT00313586|"~     This randomized phase II trial studies azacitidine with or without entinostat to see how well~     they work compared to azacitidine alone in treating patients with myelodysplastic syndromes,~     chronic myelomonocytic leukemia, or acute myeloid leukemia. Drugs used in chemotherapy, such~     as azacitidine, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Entinostat may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving azacitidine together with entinostat may work better in treating patients with~     myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.~   "
247488|NCT00313573|"~     RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer.~     It is not yet known whether telemedicine is more effective than standard care in treating~     depression and/or pain caused by cancer.~      PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it~     works compared to standard care in treating patients with depression and/or pain caused by~     cancer.~   "
247489|NCT00313560|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed. Drugs used in chemotherapy, such as~     capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving erlotinib together with combination~     chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after~     surgery.~      PURPOSE: This randomized phase II trial is studying how well giving erlotinib before and~     after surgery together with combination chemotherapy and radiation therapy works in treating~     patients with stage I or stage II pancreatic cancer that can be removed by surgery.~   "
247490|NCT00313547|"~     The purpose of this study is to compare the impact of two blood pressure lowering treatments~     (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate~     over 24 hours.~   "
247491|NCT00313534|"~     RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.~   "
247492|NCT00313521|"~     RATIONALE: Drugs used in chemotherapy, such as thiotepa, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and~     radiation therapy after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well thiotepa works together with radiation~     therapy in treating young patients with newly diagnosed malignant brain tumors.~   "
247493|NCT00313508|"~     This is a randomized, controlled, multicenter, dose-escalation study of fludarabine. Patients~     are randomized to 1 of 2 treatment arms.~      The purpose of this study is to find out what side effects are caused in this study and~     whether Fludarabine with the dendritic cell vaccine (DC vaccine) can increase the ability of~     the immune system to recognize melanoma.~   "
247494|NCT00313495|"~     The purpose of this study is to collect prospective data from individuals who are part of a~     Huntington Disease (HD) family, in order to relate phenotypes between individuals and~     families with each other and genetic factors in order to learn more about HD, develop~     potential treatments for HD, and to plan for future research studies of experimental drugs~     aimed at slowing or postponing the onset and progression of HD.~   "
247495|NCT00313482|"~     This is a Phase II, open-label study in male patients with metastatic HRPC.~      Each cycle will be 21 days (3 weeks). Patients will receive the following drugs:~        -  Docetaxel 75 mg/m2 IV given over 1 hour on Day 1.~        -  Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease~          progression.~        -  Sargramostim 250 mcg/m2 SC on Days 2-15 of each cycle. Patients will be evaluated every~          4 cycles (12 weeks) for response using RECIST criteria. PSA response will be evaluated~          according to the National Cancer Institute (NCI) PSA Working Group Criteria. To evaluate~          the safety of this drug combination, patients will be evaluated at each clinic visit for~          adverse events. Toxicities will be assessed per National Cancer Institute (NCI) CTCAE~          Version 3.0.~      Those patients achieving stable disease or better will continue therapy. Those patients~     experiencing progressive disease will be taken off study.~      Patients will receive a maximum of 10 cycles of treatment.~   "
247496|NCT00313469|"~     We propose to study the pharmacokinetic (PK) and pharmacodynamic (PD) components of the~     response to fluindione, the main oral anticoagulant used in France, in patients over 80.~      We expect to gain a better understanding of the role of age, nutritional status, genetic~     factors and drug interactions in the variability of the response to fluindione.~   "
247497|NCT00313456|"~     This is a single-center, open-label (sequential-group dose-escalation dose-finding) phase I~     study of satraplatin and docetaxel in patients who have received prior chemotherapy regimens.~     Once the MTD is determined, an additional 6 patients, all with chemotherapy-naïve HRPC, will~     be enrolled. Once a recommended dose(s) (RD(s)) for phase 2 studies has/have been determined,~     6 additional patients with chemotherapy-naïve HRPC will be enrolled at the RD to further~     evaluate safety and efficacy.~   "
247498|NCT00313443|"~     The objective of this study is to determine if concentrations of amiodarone in fat tissue~     increases constantly over time during chronic treatment with this drug, and if blood~     concentrations reflect accurately the concentrations in fat tissue or not. This is because~     excessive concentrations of this drug in tissues can produce adverse effects.~   "
247499|NCT00313430|"~     The investigators want to test the hypothesis that patients with chronic renal disease have a~     poorer ability to preserve water after being thirsty and a poorer ability to excrete water~     after a load of fluid. They presume that these abilities become poorer when renal~     insufficiency progresses. The investigators further hypothesize that patients with~     hypertension also have a decreased ability to concentrate and dilute urine.~   "
247500|NCT00313417|"~     Creatine as a new therapeutic strategy in depression:~      A double-blind, parallel, randomized, add-on clinical trial of creatine versus placebo added~     to antidepressant treatment of patients with major depressive episode.~   "
247501|NCT00313404|"~     Norwalk virus and related Norwalk-like viruses are the most common cause of outbreaks of~     stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United~     States. These viruses are sometimes found in drinking water, ice, shellfish and in other~     foods. They can be spread easily from contact with water, food, objects or hands that have~     even small amounts of feces from someone who was sick.~      The purpose of this research study is to see how long Norwalk virus can survive in water and~     still be able to cause sickness. When this is determined the researchers will be able to~     recommend risk levels for norovirus contaminated waters. Another purpose for this study is to~     see how a person's body's immune cells respond to Norwalk virus in the body. During this~     study volunteers will receive a dose of Norwalk virus in water that may make them sick.~   "
247502|NCT00313391|"~     The purpose of this study is to determine if Risperdal Consta will affect the healthcare~     utilization costs in chronically ill schizophrenic patients with multiple admissions to the~     psychiatric hospital compared to the previous utilization costs under standard oral treatment~     of any atypical antipsychotic. We hypothesize that higher Risperdal Consta acquisition costs~     can be offset by reduction in total medical utilization costs, such as hospitalizations, ER~     visits, unscheduled outpatient visits or incarcerations due to worsening of psychotic~     symptoms.~   "
247503|NCT00313378|"~     Lung surgery under thoracotomy is known to induce long-term pain which can be considered as~     neuropathic in many patients concerned [1,2]. The suspected origin of neuropathy is a direct~     traumatism of intercostal nerve(s) [3]. Among the possible preventive treatments that can be~     administered during the initial aggression, ketamine [4,5] appears as the easiest to use, as~     it is already commonly administered intra and postoperatively for improvement of analgesia~     [6].~   "
247504|NCT00313365|"~     Joint spaces are aseptic areas, meaning that they do not contain microorganisms. Any injury~     to the joint space could cause the entry of microorganisms, with the potential to cause~     infection. Septic arthritis refers to the infection of a joint space with microorganisms,~     usually bacteria. This invasion initiates a process of inflammation and causes irreversible~     damage to a joint cavity. Patients typically present with pain, swelling, decreased motion,~     and inability to use the joint. When bacteria enter a joint space, the host immune system~     responds by concentrating inflammatory cells within the joint. While inflammatory cells serve~     to eliminate the bacteria, they also produce substances that not only attack bacteria but~     also could destroy the joint space. These substances are called enzymes, and they could~     damage the cartilage (translucent fairly elastic tissue around the joint) and adjacent bone~     in the process. Because cartilage has a poor ability to cure itself, this process may lead to~     irreversible damage and chronic joint dysfunction. Studies have found that signs of early~     joint damage can be found within hours following joint infection. This is true even if~     antibiotic therapy (medicine to fight the infection) is started within 24 hours of infection.~     Also, delay in treatment has been related to poor outcome. However, the best method of~     treating septic arthritis has yet to be determined. Currently, there are two accepted ways~     for treating septic arthritis: serial needle aspiration (introducing a needle in the joint to~     aspirate the inflammatory liquid), and surgical lavage (opening and cleaning the joint space~     in the OR under anesthesia). Antibiotics are also used with these two forms of treatment.~     Supporters of surgery believe that the most dependable method of eliminating bacteria from a~     joint space is through arthrotomy (opening the joint with a surgical incision) and lavage~     (irrigation of the joint with copious saline solution) .Promoters of serial needle aspiration~     support this method because it is quick, does not require opening the joint space, and can be~     performed without anesthesia.At present, there are no conclusive studies comparing the two~     techniques. Hopefully, this study will help delineate the best course of management.~   "
247505|NCT00313352|"~     The purpose of this chart review study is to examine the effects of beta -adrenergic blocking~     agents on systemic ventricular dimensions, systemic atrioventricular valve function and~     exercise tolerance in patients with transposition of the great arteries (TGA) and systemic~     ventricular dysfunction.~   "
247506|NCT00313339|"~     Following a Heart attack the acute loss of heart muscle cells results in a cascade of events~     causing an immediate decrease in cardiac function that has the potential to persist long~     term. Despite revascularization of the infarct related artery circulation and appropriate~     medical management to minimize the stresses on the heart walls, a significant percentage of~     patients experience permanent cardiac dysfunction and consequently remain at an increased~     life-time risk of experiencing adverse cardiac events, including death.~      There is a great potential for stem cell therapy, using a variety of cell precursors~     (particularly hematopoietic,)to contribute to new blood vessel formation (and possibly~     limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The~     administration of cells via an infusion through the infarct related artery appears to be~     feasible and result in a clinical effect in some studies.~      Therefore, we propose to evaluate the safety and efficacy of a CD34+ selected stem cell~     product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after~     successful infarct related artery stent placement.~      The primary objective of the study is to determine the feasibility and safety of~     prospectively identifying patients at risk for clinically significant cardiac dysfunction~     following a myocardial infarction and the ability to isolate and infuse via the affected~     coronary circulation an autologous bone marrow derived CD34+ cell product at four dose~     levels.~      The secondary objective of the study is to assess the effect on cardiac function and infarct~     region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+~     cells will be evaluated similar to the treated group to assess the rate of significant~     spontaneous improvement in cardiac function without CD34+cell infusion.~   "
247507|NCT00313326|"~     This is a comparative study of duration of respiratory weaning between adaptive support~     ventilation and succession of controlled ventilation then spontaneous ventilation for~     patients after surgery.~   "
247515|NCT00313222|"~     The present trial investigates a possible use of oral bosentan, which is currently approved~     for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering~     from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i)~     peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary~     hypertension after pulmonary endarterectomy.~   "
247516|NCT00313209|"~     The aim of the study is to compare the efficacy of roflumilast on pulmonary function and~     symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during~     concomitant administration of salmeterol. The study duration will last up to 28 weeks. The~     study will provide further data on safety and tolerability of roflumilast.~   "
247517|NCT00313196|"~     The study will assess the effect of bosentan on pulmonary vascular resistance and exercise~     capacity in Sickle Cell Disease (SCD) patients diagnosed with Pulmonary Hypertension. It~     consists of 3 phases: screening, treatment and follow-up. During the screening visit, the~     study doctor will decide if patients meet the study requirements. All potential patients will~     have a diagnosis of increased pulmonary artery pressures that is shown by right heart~     catheterization conducted shortly prior to start of study treatment. Patients will be asked~     to perform exercise capacity test (walking as far as possible for 6 minutes). Following the~     baseline visit the treatment phase consists of 4 additional clinic visits during which the~     good and bad effects of the drug are reviewed and exercise capacity test will be repeated.~     Patients will be treated for 16 weeks. Blood samples will be collected every month, or more~     often, if needed. At the end of the study some of the patients will be asked to repeat the~     right heart catheterization. All patients will repeat an exercise capacity test. After~     completion of the study, patients will have the option of enrolling in a long-term follow-up~     study where all patients will receive active drug. Patients electing not to participate in~     the extension study will be followed up for safety assessments for about 28 days after the~     end of the study treatment.~   "
247518|NCT00313183|"~     This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes~     mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and~     physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these~     subjects.~   "
247519|NCT00313170|"~     This study will assess the relationship between fulvestrant dose and efficacy in~     postmenopausal women with oestrogen receptor positive advanced breast cancer.~   "
247520|NCT00313157|"~     The purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and~     carvedilol on ventricular rate, working capacity and quality of life in patients with chronic~     atrial fibrillation.~   "
247521|NCT00313144|"~     The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are~     to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are~     initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related~     quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory~     analyses to evaluate the safety of long-term administration of ARALAST.~      Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every~     6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw~     portion of the study, which will also include assessments of antibodies to ARALAST, and~     chemistry panel. Subjects will be treated according to the prescribing (attending)~     physician's instructions based on the prescribing information given in the ARALAST package~     insert.~   "
247522|NCT00313131|"~     This randomised controlled trial aimed to verify whether directly observed single dose~     treatment (with tinidazole+fluconazole) would be as effective as the longer standard~     treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic~     management of women presenting with vaginal discharge in primary health care centers of~     Ghana, Togo, Guinea and Mali. It was designed as an effectiveness trial, i.e. it was done~     under conditions typical of routine work in these health centers~   "
247523|NCT00313118|"~     Determination of the mean value of oxidative stress parameters in normals and of the plasma~     and serum levels, resp. of malondialdehyde, glutathion and superoxide dismutase in healthy~     subjects.~   "
247524|NCT00313105|"~     To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking~     cessation compared with a control group with low dose nicotine patches.~      Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½~     year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure,~     lung function and body weight every 6 months for 2 years.~   "
247525|NCT00313092|"~     The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict~     glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity~     will decrease after one month of nCPAP-treatment.~   "
247526|NCT00313079|"~     A phase I trial in patients with relapsed or refractory leukemia of a human monoclonal~     antibody that kills B cell acute lymphoblastic leukemia. Trial will study safety,~     pharmacokinetics, and anti tumor activity of the antibody given as a single agent and with~     vincristine.~   "
247527|NCT00313066|"~     Connective tissue growth factor (CTGF) is known to be a fibrogenic cytokine, it could be~     expressed in various fibrosis diseases. But, recent research showed that CTGF also be~     considered to be a tumor suppressive gene. The expression of CTGF protein is higher in normal~     Type I and II alveolar epithelial cells than metastatic tumor cells. CTGF appears to be a~     suppressor of lung tumor invasion and in metastasis and the decreased CTGF expression in~     tumor tissues was associated with advanced tumor stage, lymph node metastasis, early~     postoperative relapse and shorter patient survival.~      CTGF can be expressed in many human organs such as heart, brain, placenta, liver, muscle,~     kidney, peritoneal mesothelial cells and lung but did not known in the pleura. The CTGF~     protein is present in the peritoneal cavity and is increased during peritonitis. Considering~     pleural cavity comes from the same origin of mesenchyma with peritoneum, pericardium and~     fallopian tube, we aim to evaluate whether the CTGF expression increase in the pleurisy~     patients including the parapneumonic effusion and the TB pleurisy.~      The diagnosis of TB pleurisy depends on the effusion TB culture and pleural biopsy.~     Unfortunately the sensitivity of TB culture was only 20-30%. So most patients must receive~     invasive pleural biopsy. Adenosine deaminase(ADA) was developed as a screening test but~     should not be considered an alternative test to culture and biopsy. The sensitivity of ADA~     might vary from 32%-100% and the cutoff value also vary from 26 to 70 IU/L. We should develop~     a method to alternate the culture and biopsy . Therefore, our technologist Jao-Jia chu will~     develop the CTGF ELISA kit for this specific aim. If CGTF might increase expression in~     pleuritis but decrease in pleural metastasis, it might be a potential method help to~     differentiate lymphocytic pleural effusion between TB pleurisy and malignancy.~   "
247528|NCT00313053|"~     This is a phase I trial in patients with relapsed or refractory leukemia of a human~     monoclonal antibody that kills B cell acute lymphoblastic leukemia. The trial will study the~     safety, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent and~     with vincristine.~   "
247529|NCT00313040|"~     Recent research suggests that overweight persons who are physically active may be~     significantly less likely to develop health complications and less likely to die early when~     compared even with lean persons who are not physically active. Previous treatment programs~     for people who have struggled with their weight have focused almost entirely on weight loss~     as the main goal of treatment. Our research program has a different focus. We hope to improve~     health and healthy self esteem independent of body weight by focusing instead on increasing~     physical activity as the main goal of treatment. This is a small study designed to see if~     this approach would be appealing to persons who are struggling with their weight who are~     currently sedentary. It is designed for people who are otherwise fairly healthy for whom~     exercise is reasonably safe. Participants are randomly (by chance) assigned to participate in~     the experimental treatment program or instead to meet with their regular primary care doctor.~     Those who are assigned to meet with their regular doctor can access traditional weight loss~     resources such as Weight Watchers, Jenny Craig, Fitness centers etc... After the experiment~     is complete, these participants will have the opportunity to participate in the experimental~     treatment program.~   "
247530|NCT00313027|"~     The purpose of this study is to determine the value of novel non-invasive medical imaging~     methods for detecting the spread of head and neck squamous cell carcinoma to the lymph nodes~     in the neck by comparing their results to findings at the time of surgery.~   "
247531|NCT00313014|"~     The objective of this study is to demonstrate the effectiveness and tolerability of the~     buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal~     system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back~     pain currently treated with oral opioids. The double-blind treatment intervention duration is~     12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will~     be provided to all subjects in addition to study drug.~   "
247532|NCT00313001|"~     This trial is conducted in the United States of America (USA). The study will compare A1C~     reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to~     patients receiving exenatide twice daily. Patients enrolled in the study will be insulin~     naive patients who have not achieved glycemic control with metformin and sulfonylurea.~   "
247533|NCT00312988|"~     Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and~     Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.~   "
247534|NCT00312975|"~     The purpose of this trial is to study how long patients can remain progression free when they~     receive CP-675,206, compared to how long patients can remain progression free when they~     receive best supportive care. If you choose to take part, you will be randomized to receive~     either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means~     you will not receive any study drug or other treatment for your cancer. Best supportive care~     could include treatment with antibiotics, analgesic drugs (medicine for pain), blood~     transfusions or psychosocial and nutritional support, depending on your needs. You have a 50%~     chance of being randomized to receive CP-675,206.~   "
247535|NCT00312962|"~     This study will determine the effectiveness of reward-intensive, computer-based targeted~     cognitive training in improving neurocognitive deficits in people with schizophrenia.~   "
247536|NCT00312949|"~     This study will evaluate the effectiveness of an interactive educational website in enhancing~     discussions about treatment issues and improving the quality of care for people with~     schizophrenia.~   "
247537|NCT00312936|"~     We are exploring the effect that an 8 week stress reduction program based in mindfulness~     practices will have on the experience of medication side effects reported by HIV-infected men~     and women taking antiretroviral therapy.~   "
247538|NCT00312923|"~     Lay Language Summary: High cholesterol levels are common in persons with HIV infection.~     However, conventional cholesterol-lowering medications may have harmful side effects when~     given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of~     policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering~     properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that~     policosanol will lower levels of LDL cholesterol (bad cholesterol) and raise levels of HDL~     cholesterol (good cholesterol).~   "
247539|NCT00312910|"~     The purpose of this study is to determine whether probiotics are effective in the prevention~     of the complications of liver cirrhosis.~   "
247540|NCT00312897|"~     Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of~     adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of~     omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1)~     change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the~     end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end~     of 10-week treatment.~      Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant~     reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at~     the end of treatment compared to placebo.~   "
247541|NCT00312884|"~     This project, using home monitoring for the signs and symptoms of heart failure, aims to~     empower patients to be actively involved in their care and provide rapid access to healthcare~     services and advice when needed. The telemonitoring system is easy to use and ensures the~     accurate transfer of information from the home to the hospital. The information is then~     screened and if important changes are seen, the patient will be contacted by a heart failure~     nurse who will offer advice and may arrange a clinic visit or suggest alterations to the~     medication. The project uses modern technology to provide disease management, links the~     patient in their home with the hospital and reinforces education and self-care behaviour.~     This innovative programme will be tested to see if it reduces the risk of re-admission to~     hospital, reduces anxiety, improves quality of life following a hospital admission for heart~     failure and whether this represents good value for money in terms of the health benefits it~     provides.~      Hypothesis:~      Patients using home telemonitoring of signs and symptoms of heart failure following discharge~     from hospital with chronic heart failure have a reduced risk of all-cause re-hospitalisation~     when compared with usual care.~   "
247597|NCT00312156|"~     The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use~     of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of~     NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves~     children and adolescents with Type 1 Diabetes.~   "
247542|NCT00312871|"~     The purpose of the study is to assess the effect of an early and complete correction of~     anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure~     (which involves improper functioning of the kidneys). It also assesses the effect of~     hemoglobin normalization (correction of anemia) on the need for renal (kidney) replacement~     therapy, quality of life, blood pressure control, hospital admissions, mortality,~     cardiovascular events, nutritional status and safety.~   "
247543|NCT00312858|"~     Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and~     varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together~     with measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine at the second dose.~     Immunogenicity and safety data will be collected after each dose of vaccine.~   "
247544|NCT00312845|"~     The purpose of this study is to determine if the combination of VELCADE and rituximab~     improves progression free survival relative to rituximab alone in patients with relapsed or~     refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have~     previously responded to rituximab. This is an international study being conducted in the~     United States and in many countries around the world. A complete list of study locations is~     listed below.~   "
247545|NCT00312832|"~     Background: Stavudine-containing regimens are associated with a potential for lipoatrophy and~     dyslipidemia. We assessed the safety and efficacy of reducing the dose of stavudine compared~     to switching to tenofovir or maintaining the standard dose of stavudine.~      Methods: Clinically stable lipoatrophic HIV-infected patients receiving antiretroviral~     therapy containing stavudine 40 mg bid with a plasma HIV RNA <200 copies/mL for at least 6~     months were randomized to maintain stavudine 40 mg bid (d4T40 arm), to reduce to 30 mg bid~     (d4T30 arm), or to switch from stavudine to tenofovir-DF (TDF arm) while preserving the~     remaining drugs. Fasting metabolic parameters were assessed at baseline and at weeks 4, 12,~     and 24. Mitochondrial parameters in peripheral blood mononuclear cells and body composition~     were measured at baseline and at week 24.~   "
247546|NCT00312819|"~     Recent studies in laboratory animals demonstrate the ability of disulfiram to significantly~     inhibit the growth and metastasis of a mouse model of lung cancer. Work with cells in vitro~     support the idea that this inhibition is mainly due to the inhibition of angiogenesis - the~     formation of new blood vessels in the tumor. Furthermore, it was found out that the best~     effect has been obtained when disulfiram has been used not at the highest dose but at an~     optimal dose, which is smaller. Thus, this trial will assess the addition of disulfiram to~     chemotherapy in non-small cell lung cancer (NSCLCA).~   "
247547|NCT00312806|"~     The aim of the present study is to identify factors (such as symptom patterns and symptom~     scores) that influence the response to treatment with pantoprazole using different evaluation~     methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole~     will be administered once daily in the morning at one dose level. The study duration consists~     of a treatment period of 8 weeks. The study will provide further data on safety and~     tolerability of pantoprazole.~   "
247548|NCT00312793|"~     This study is designed to evaluate the efficacy and safety of Myospare, a non-invasive~     device, which is connected to the body via electrodes placed in the injured leg. The~     electrodes which are placed in the middle or upper thigh will stimulate the quadriceps~     muscle.~      Myospare will be installed 1 day after the anterior cruciate ligament (ACL) reconstruction~     surgery and will be removed after 6 weeks of treatment. The patients will be assigned to two~     groups:~        1. Physiotherapy plus Myospare~        2. Only physiotherapy~      The hypothesis of the study is that electrical stimulation combined with voluntary exercise~     is more effective than voluntary exercise alone.~   "
247549|NCT00312780|"~     This clinical study is being conducted at multiple sites to determine the activity, safety~     and tolerability of XL784 when given daily to patients with albuminuria due to diabetic~     nephropathy. XL784 is a small molecule reno-protective metalloproteinase inhibitor,~     inhibiting both ADAMs (including ADAM10, a target of significant interest because of its~     important role in blood vessel formation and cell proliferation, and ADAM17/TACE, activation~     of which has been associated with renal deterioration) and MMPs (including MMP-2 and MMP-9).~     XL784 was specifically optimized to be MMP-1 sparing, which may be clinically significant~     because inhibition of MMP-1 has been hypothesized to be associated with musculoskeletal~     toxicity.~   "
247550|NCT00312767|"~     People with Fabry disease have an alteration in their genetic material (DNA) which causes a~     deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and~     remove certain types of fatty substances called glycolipids. These glycolipids are normally~     present within the body in most cells. In Fabry disease, glycolipids build up in various~     tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not~     present, or is present in small quantities. The build up of glycolipid (globotriaosylceramide~     or GL-3) levels in these tissues in particular is thought to cause the clinical symptoms that~     are common to Fabry disease. This study is designed to verify that no loss of Fabrazyme~     occurs during simultaneous Fabrazyme infusion and hemodialysis in patients currently~     receiving Fabrazyme at a dose of 1.0 mg/kg every 2 weeks.~   "
247551|NCT00312754|"~     The purpose of this clinical research study is to learn if BMS-232632 administered as~     Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including~     Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated~     vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be~     studied.~   "
247552|NCT00312741|"~     The hypothesis is that community-acquired pneumonia is usually a monomicrobial infection.~     Therefore, early detection of the etiology allows to select the most active, narrow-spectrum,~     and cheap, and less toxic antibiotic agent.~   "
247553|NCT00312728|"~     This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with~     first- or second-line therapy in patients with metastatic non-squamous non-small cell lung~     cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of~     115 patients enrolled in the study.~   "
247572|NCT00312481|"~     This will be a randomised, single-centre, single-blind, parallel-group, pilot study in~     patients undergoing colonoscopy.~      The primary objective is to evaluate the efficacy of MOVIPREP® versus PICOLAX® for gut~     cleansing prior to colonoscopy.~      The secondary objectives are to evaluate the safety, tolerability and acceptability of~     MOVIPREP versus PICOLAX for gut cleansing prior to colonoscopy.~   "
247554|NCT00312715|"~     This study will use a technique called microperfusion to examine how thyroid hormones are~     involved in fat metabolism. The thyroid gland produces two kinds of hormones: T3 and T4. Some~     of the T4 is changed to T3 in various organs after leaving the thyroid. The T3 stimulates the~     body to burn fat. People have different rates at which they can change T4 to T3, and this may~     lead to differences in body fat among different people.~      Microperfusion is based on the exchange of substances across tiny holes of a small plastic~     tube called a probe, which is inserted after numbing the skin over a fat pad. Through these~     openings, the fat pad is continuously rinsed with small amounts of fluid, and an exchange of~     substances occurs. The fluid drips from the other opening of the probe and is collected in a~     vial. Small amounts of study drugs are infused and the amount of substances released by the~     fat pad in response to them are measured.~      Healthy normal volunteers 18 years of age and older may be eligible for this study.~     Candidates are screened with a medical history, physical examination and blood tests.~      Participants undergo microperfusion. A needle is placed in an arm vein for collecting blood~     samples before and at the end of the experiment for measuring thyroid hormones and other~     substances in the blood. The skin over the fat pad next to the umbilicus (navel) is numbed~     and two microperfusion probes are inserted. A salt water solution is infused into the fat pad~     for one hour and the substances in the fluid are measured as the fluid leaves the fat pad.~     After 1 hour isoproterenol, a drug that aids in energy production by fat, is added to help~     determine the level of fat metabolism. After an additional hour small amounts of thyroid~     hormone are added to the fluid and samples are collected as they leave the body. Two~     catheters are inserted during each experiment. Small volumes of sterile fluid are circulated~     continuously in the tubing and samples are collected at regular intervals.~   "
247555|NCT00312702|"~     Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of~     America.~   "
247556|NCT00312689|"~     Children with congenital lacrimal stenosis are treated by probing and intubation of the~     lacrimal drainage system.~      Hypothesis: Microbiological findings at the time of insertion and removal of the silicon~     intubation have an influence on the clinical outcome and success rate of the surgical~     treatment. Microbiological specimens are taken from conjunctiva and nasal mucosa during the~     two procedures under general anaesthesia and from the silicon tube after removal and examined~     for bacterial contamination.~   "
247557|NCT00312676|"~     The hypothesis is that the characteristics of extended release Depakote will allow overnight~     conversion of immediate release to extended release form of Depakote. This has been tested~     successfully in younger patients but not in individuals over the age of 60. We will include~     individuals between 60 and 80 years old.~   "
247558|NCT00312663|"~     Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of~     America.~   "
247559|NCT00312650|"~     Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One~     of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study~     investigates using a lower dose given more frequently in combination with a second drug~     Gemcitabine.~   "
247560|NCT00312637|"~     The purpose of this study is to evaluate whether high-resolution magnetic resonance imaging~     of the axilla with spectroscopy can identify nodal features suggestive of metastatic~     involvement in patients diagnosed with invasive breast cancer. This may enable us to define a~     select group of patients for whom axillary lymph node dissection could be avoided.~   "
247561|NCT00312624|"~     This is a pilot study to find a correlation between MRI and ICD therapy in patients with~     known cardiomyopathies, aiming to determine if cardiac scarring identified by MRI correlates~     with ventricular arrhythmias and the occurrence of ICD therapy.~   "
247562|NCT00312611|"~     The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System~     in a population of patients with a BMI between 35 and 55.~   "
247563|NCT00312598|"~     Weight gain is a serious, common side effect of many antipsychotic medications. On average,~     the highest amounts of weight gain are found to occur in people taking clozaril and~     olanzapine, but with significant weight gain occuring in those on the other atypical~     antipsychotics as well.~      We, the researchers at the University of North Carolina, propose an open-label observational,~     pilot study of the changes in weight, BMI, body composition, and lipids, glucose, insulin and~     other metabolic parameters occurring in subjects as they switch from treatment with~     olanzapine, risperidone or quetiapine to aripiprazole. This medication switch will be~     determined prior to their entering this study by their treating psychiatrist. We also will~     determine resting energy expenditure (REE) and respiratory quotient (RQ) as measured by~     metabolic cart to determine if either energy expenditure or the propensity to store energy as~     fat may be involved in any changes to weight that are detected. Food intake, hunger, and~     physical activity will also be assessed.~   "
247564|NCT00312585|"~     The purpose of this study is to assess if acupuncture can shorten the time to delivery for~     women who are experiencing their first, full-term pregnancy.~   "
247565|NCT00312572|"~     The objective of this study is to evaluate the safety and efficacy of dose conversion from~     hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in~     subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention~     duration is 2 weeks during which time supplemental analgesic medication will be allowed.~   "
247566|NCT00312559|"~     To determine if yoga is beneficial in improving physical function quality of life and medical~     status in people with Parkinson's disease~   "
247567|NCT00312546|"~     A histone deacetylase (HDAC) inhibitor is a class of drug that interferes with the function~     of HDAC, an enzyme that hides HIV within inactive CD4 cells. These drugs are normally used to~     treat seizures and other nervous system problems but have been found to work against HIV. The~     purpose of this study is to investigate the efficacy of valproic acid (VPA), an HDAC~     inhibitor, in treating HIV infected adults using anti-HIV drugs.~   "
247568|NCT00312533|"~     The goal of viscosupplementation is to replenish synovial fluid, which will improve patient~     symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has~     been shown to improve symptoms in patients with osteoarthritis. Recent studies have shown~     that this improvement may be highly variable based on the time from treatment, especially in~     the first 12 weeks following treatment. The purpose of this study is to document the outcomes~     following a treatment protocol in which corticosteroid is used in addition to the initial~     Synvisc injection in the series of three injections.~   "
247569|NCT00312520|"~     The purpose of the study is to determine if pulse steroids are more efficacious and safer~     than the standard treatment with oral corticosteroids.~   "
247570|NCT00312507|"~     The objective of this pilot study is to examine the feasibility and safety of performing a~     larger trial to assess outcomes following treatment of meconium aspiration syndrome with~     surfactant lavage compared to bolus surfactant. Specifically, we will determine if surfactant~     lavage results in a more rapid improvement in physiologic outcomes (e.g. pulmonary~     compliance), as well as clinical outcomes (e.g. length of time on mechanical ventilation).~   "
247573|NCT00312468|"~     Recent studies have shown that HIV infected individuals have an increased risk of developing~     heart disease, but the reason for this is not fully understood. This study will examine~     ultrasound test results of blood vessels and laboratory data of HIV infected and HIV~     uninfected women to examine the link between heart disease and HIV infection.~   "
247574|NCT00312455|"~     Many substance dependent individuals continue to abuse a variety of substances during~     treatment for their disorder. Often, substance dependent individuals are co-diagnosed with~     depression and violence problems. Supplements of n-3 polyunsaturated fatty acids (PUFAs) may~     play a role in treating individuals with such substance abuse problems. The purpose of this~     study is to evaluate the effectiveness of the n-3 PUFAs eicosapentaenoic acid (EPA) and~     docosapentaenoic acid (DPA) in treating relapse, aggression, and depression in substance~     dependent individuals.~   "
247575|NCT00312442|"~     The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated~     vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer~     recurrent after external radiation therapy or temporary (High Dose Rate, or HDR)~     brachytherapy.~   "
247576|NCT00312429|"~     Umbilical cord blood is an important source of stem cells and can be used to treat blood and~     immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord~     blood have been shown to be effective in treating illness in children, but more research is~     needed to confirm the benefit of this procedure in adults. The purpose of this study is to~     examine the immune system response to cord blood stem cell transplantation in adults with~     advanced blood disorders or cancer.~   "
247577|NCT00312416|"~     Brimonidine tartrate is an alpha-2 agonist ocular hypotensive drug that exerts its effect by~     causing both a decrease in aqueous production and an increase in uveoscleral outflow. It has~     been proven to reduce increased intraocular pressure in glaucoma and ocular hypertension. As~     an alpha 2 agonist Brimonidine belongs to the same class of drugs as Clonidine; however, its~     molecular structure is sufficiently different to make it more selective for the alpha 2~     receptor than Clonidine. Unlike Clonidine, Brimonidine does not appear to have an effect on~     the central nervous system and therefore does not cause sedation or systemic hypotension.~      In addition to their known effect of lowering intraocular pressure, alpha 2 adrenoceptor~     agonists are neuroprotective. It has, however, been shown that Brimonidine is a very potent~     vasoconstrictor in the ciliary body thus reducing aqueous humor production. Little is,~     however, known about potential vasoconstrictor effects of Brimonidine in the posterior pole~     of the eye. This is of clinical importance, because optic nerve head ischemia appears to~     contribute to glaucoma pathophysiology.~      This study is performed to investigate the effects of topical Clonidine vs. topical~     Brimonidine on choroidal blood flow and intraocular pressure during isometric exercise.~   "
247578|NCT00312403|"~     Matrix metalloproteinases (MMPs) fulfill diverse important molecular functions and play~     pivotal roles in development, tissue morphogenesis, repair, aging, and inflammatory~     processes. MMPs are also important disease modulating factors, such as cancer, cardiovascular~     disease, rheumatoid arthritis or macular degeneration. Functional genetic variants have been~     described to fine-tune MMP activities at the gene transcriptional level and have been~     associated with increased genetic risk of e.g. arteriosclerosis or cancer. MMPs are also~     assumed to play a major role in the remodeling of the extracellular matrix (ECM) in the optic~     nerve head during glaucomatous optic neuropathy. MMP-1, MMP-3 and MMP-9 have been shown to be~     up-regulated in a variety of animal models of glaucoma. Here, we study three promoter SNPs~     within the genes encoding three members of the MMP family. By assessing the prevalence of~     genetic variants associated with either increased/decreased enzyme activity, we will (i)~     estimate their contribution to the genetic risk of developing primary open angle glaucoma~     (POAG) and (ii) investigate the potential role of MMPs in the functional pathology of POAG.~   "
247579|NCT00312390|"~     The visual disorder of amblyopia affects 2% to 3% of the population. Amblyopia is a~     developmental condition that is characterized by reduced vision of the eye due to the~     presence of a sensory impediment during visual development, such as strabismus (ocular~     misalignment) or anisometropia (unequal refractive error), occurring early in life. Recent~     studies in humans and animals point towards a cortical locus for the processing deficit in~     amblyopia, revealing sensory deficits at the signal cell level that include reduced spatial~     resolution, reduced contrast sensitivity, and a reduced number of binocular neural cells. In~     the retina, however, no abnormalities have yet been reported.~      Like in the brain blood flow in the retina is coupled to neuronal activity. This phenomenon~     has been measured by different study groups with non invasive techniques in the brain and~     retina. We therefore use a Zeiss fundus camera for the assessment of retinal vessel~     diameters. This so called retinal vessel analyzer (RVA) is a combination of a fundus camera~     connected to a high resolution video camera equipped with a software based analyzing system.~     An unprecedented reproducibility and sensitivity of retinal vessel diameter measurements is~     attained with this system. In addition this system allows real time analysis of retinal~     vessels as well as off-line determinations from video tape. A special provocation test, which~     minimizes risk and discomfort to the subject under study is applied through the illumination~     pathway of the fundus camera: Diffuse luminance flicker is used as a stimulus to augment~     intrinsic mechanisms by which the retina can vary the vascular supply, in correspondence with~     local variations of functional activity. This system allows to study the flicker response of~     retinal vessels, which is within a magnitude of 6 to 8%.~      However, the exact mechanisms underlying this phenomenon are not fully understood. Especially~     in the eye it is not clear whether it is an exclusive metabolic effect within the retina and~     the surrounding blood vessels or dependent of central regulatory brain functions.~      The purpose of the current study is to improve our understanding of the mechanisms underlying~     flicker evoked responses of retinal blood vessels in humans. It is not clear whether the~     retina of amblyopic eyes can regulate retinal blood flow in response to increased metabolic~     demands as induced during flicking light stimulation. A detail understanding of the metabolic~     and functional processes within the retina of patients with amblyopia is a prerequisite for~     further research to prevent amblyopia.~   "
247596|NCT00312169|"~     This is a multicenter, open-label, non-randomized, dual-arm pilot study to investigate the~     prevalence of the reverse transcriptase (RT) resistance mutations, K65R/x or L74V/x, in HIV-1~     plasma from subjects experiencing confirmed first-time incomplete virologic suppression~     during treatment with an initial antiretroviral (ARV) regimen consisting of at least 12 weeks~     of TDF or ABC + emtricitabine (FTC) or lamivudine (3TC) + non-nucleoside reverse~     transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Subjects will be followed until a~     substantial loss of virologic or immunologic control requires a treatment switch. Confirmed~     first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA~     response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two~     consecutive times.~      Subjects will have a screening genotype to establish adherence to their non-suppressive TDF-~     or ABC-containing regimen by the presence of M184V (or other treatment-related primary)~     mutation and to demonstrate that the evolution of treatment-emergent RT mutations can be~     characterized.~      Twenty subjects (a maximum of 10 per arm) will be enrolled at 10-20 United States (U.S.)~     sites. If fewer than 20 subjects can be enrolled, the study may be discontinued early by the~     sponsor. Equal numbers of subjects on Arm A versus Arm B will be a goal.~   "
247580|NCT00312377|"~     This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in~     treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets~     the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor~     receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial~     growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in~     lung cancer patients who have had their cancer re-appear after treatment with standard~     chemotherapy.~      This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can~     deliver longer improved progression free survival and improved overall survival than~     docetaxel (Taxotere) alone.~      All patients participating this clinical study will receive treatment with docetaxel, a~     commonly used treatment for recurrent non-small cell lung cancer.~      In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF~     agent.~      Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR)~     inhibition, when used with standard chemotherapy, can lead to increased survival in advanced~     non-small cell lung cancer (NSCLC) patients.~      Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib~     (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour~     cells and stopping them from dividing.~   "
247581|NCT00312364|"~     This is a clinical research study of an experimental topical drug for the treatment of~     chronic, neuropathic, diabetic foot ulcers.~      Patients participating in the study may receive an active drug (MRE0094), inactive drug~     (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the~     United States. What treatment a patient will receive is determined by chance (like drawing a~     number from a hat). All patients will receive additional care for diabetic foot ulcers during~     the study.~      Participation in the study can be up to 4½ months.~   "
247582|NCT00312351|"~     The purpose of this trial is to compare the ability of three different doses of pegaptanib~     sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing~     or improving vision in patients with wet AMD. The study will also examine the effects of~     pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.~   "
247583|NCT00312338|"~     Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora~   "
247584|NCT00312325|"~     Because of their antiinflamatory effects, glucocorticoids are often used to reduce edema in~     neurologic tissue and to otherwise mitigate the consequences of neural inflammation. For~     example, high dose prednisolone treatment has been shown to be an effective therapy for~     different eye diseases including severe Graves´ Ophthalmopathy and acute optic neuritis.~     However, contradictory results exists for the influence of high dose prednisolone therapy per~     se on tissue blood flow. Thus, in the current study, we plan to investigate the effect of~     high dose, short time therapy with intravenous prednisolone in patients with optic neuritis~     and severe Graves´ Ophthalmopathy.~   "
247585|NCT00312312|"~     The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic~     rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory~     markers, and among others, exhaled nitric oxide.~   "
247586|NCT00312299|"~     First object is to compare square edge PMMA with round edge PMMA IOL where the materials are~     same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials~     are different~   "
247587|NCT00312286|"~     The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations~     and dosing regimens on high-risk cervical human papillomavirus infection in women.~   "
247588|NCT00312273|"~     The purpose of this study is to evaluate the effect of aminophylline in patients with~     out-of-hospital bradyasystolic cardiac arrest.~   "
247589|NCT00312260|"~     The objective of the study is to compare the efficacy of gabapentin and amitriptyline for~     treating neuropathic pain in children in a randomized controlled trial.~   "
247590|NCT00312247|"~     The purpose of this research study is to understand the walking patterns, strength and~     function changes of boys with Duchenne muscular dystrophy on/off corticosteroids to determine~     the best timing and treatment options to maintain walking for as long as possible.~   "
247591|NCT00312234|"~     This study is comparing two different exercise programs, Qi Gong (gentle stretching, and~     breathing) with an aerobics program (boxing and dancing) to see if children with chronic pain~     or fibromyalgia are able to take part in the program. We would also like to know if it is~     easy to take part in an exercise program.~      We hypothesize that children with chronic musculoskeletal pain and FM, who engage in Qigong~     fitness training, will be more compliant, and have an equivalent or possibly superior~     improvement on measures of motor function (peak power, endurance, and metabolic efficiency)~     compared to children given an aerobic fitness exercise program.~   "
247592|NCT00312221|"~     The objective of this study is to demonstrate the effectiveness and tolerability of the~     buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal~     system (5 mg) and oxycodone immediate release in subjects with moderate to severe~     osteoarthritis pain currently treated with oral opioids. The double-blind treatment~     intervention duration is 12 weeks during which time supplemental analgesic medication~     (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in~     addition to study drug.~   "
247593|NCT00312208|"~     Primary objective :~        -  To compare disease-free survival after treatment with docetaxel in combination with~          doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by~          docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive~          axillary lymph nodes.~      Secondary objectives :~        -  To compare toxicity and quality of life between the 2 above-mentioned arms.~        -  To evaluate pathologic and molecular markers for predicting efficacy.~   "
247594|NCT00312195|"~     The objective of this study is to demonstrate the effectiveness and tolerability of the~     buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal~     system in subjects with chronic nonmalignant pain syndromes currently controlled by oral~     opioids. The double-blind treatment intervention duration is 2 weeks during which time~     supplemental analgesic medication (acetaminophen) will be provided to all subjects in~     addition to study drug.~   "
247595|NCT00312182|"~     To assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG~     evaluation~   "
247599|NCT00312130|"~     This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase~     insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and~     elevated levels of fasting glucose.~   "
247600|NCT00312117|"~     Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged~     hospitalization, significant morbidity/mortality, and cost. In addition, these patients may~     require temporary or permanent hemodialysis which, in turn, is associated with further~     morbidity, mortality, and cost. CN has been reported to account for 10% of hospital acquired~     renal failure. In recent years, studies have investigated preventive therapies with mixed~     results. Fenoldopam was found to be ineffective in a large randomized trial. Dopamine has~     been shown to be ineffective as a preventive strategy. Hemofiltration has been shown to be~     beneficial (New England Journal of Medicine [NEJM] 2003) but is costly and not practical.~     Mucomyst has shown mixed results. The single strategy which most would agree as being~     beneficial remains hydration, most commonly with intravenous 0.9% normal saline. Most~     recently, sodium bicarbonate has been shown to be beneficial in a small randomized trial~     (n=119). It is clear that the most cost effective strategies for treatment of CN should be~     aimed at prevention.~      The general question is: Is a sodium bicarbonate solution more efficacious in preventing~     contrast nephropathy compared to normal saline? The general hypothesis is that sodium~     bicarbonate will be more efficacious.~   "
247601|NCT00312104|"~     The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of~     insulin detemir twice daily combined with mealtime insulin aspart against that of insulin~     glargine once daily combined with mealtime insulin aspart. The trial involves patients with~     Type 1 Diabetes.~   "
247602|NCT00312091|"~     The purpose of this study is to compare the blood levels, absorption, and breakdown of~     lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the~     individual liquid formulations of the same anti-HIV drugs in HIV infected Thai children.~   "
247603|NCT00312078|"~     The purpose of this study is to determine whether a special yogurt can improve performance on~     certain tests of intelligence and decrease liver inflammation in patients with cirrhosis.~   "
247604|NCT00312065|"~     The purpose of this study is to examine the need for reflective heat shield covers over the~     temperature probes applied to the skin of newborn babies who are being nursed under a radiant~     warmer.~   "
247605|NCT00312052|"~     The primary purpose of this study is to assess the safety and tolerability of E5555 in~     subjects with coronary artery disease.~   "
247606|NCT00312039|"~     HIV-1 infected patients receiving long-term therapy with lamivudine or emtricitabine~     (nucleoside reverse transcriptase inhibitors [NRTIs]) are at risk for the development of a~     mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers~     resistance to both drugs (> 100 fold increase in IC50).~      In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation~     show only a 10-fold increase in IC50 as compared to wild type HIV-1. Achillion~     Pharmaceutical's intention is to demonstrate that 10 mg of elvucitabine, administered once~     per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall~     in HIV-1 RNA plasma levels, as compared to baseline. The data from this study will guide~     dosing in future long-term studies in HIV-1 infected patients with the M184V mutation.~   "
247607|NCT00312026|"~     This is a Phase IV randomized, double-blind, placebo-controlled study to evaluate the safety~     and efficacy of SC efalizumab in adult patients (18 years of age and older) with chronic~     moderate to severe plaque psoriasis involving the hands and/or feet who have had no previous~     exposure to efalizumab. The study will consist of a screening period, a treatment period, and~     an observation period.~   "
247608|NCT00312013|"~     This study will evaluate the effects of nadroparin on survival and disease progression in~     patients with hormone-refractory prostate cancer (HRPC), locally advanced pancreatic cancer~     or non-small-cell lung carcinoma (NSCLC).~   "
247609|NCT00312000|"~     Primary objective:To assess the efficacy, defined as overall survival, of sequential versus~     combination chemotherapy for advanced colorectal cancer (CRC).~      Methodology Open, randomised multicenter phase III study. Randomisation by centre will be~     centralized. 820 patiënts with histologically proven advanced CRC; not amenable to curative~     surgery. Measurable or evaluable disease. Age 18 years and above. WHO performance status 0-2.~      Test products:~      Arm A: First line: capecitabine capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 (q3),until~     progression or unacceptable toxicity. Second line: irinotecan 350 mg/m2 IV infusion on day 1~     (q3),until progression or unacceptable toxicity. Third line: oxaliplatin 130 mg/m2 IV~     infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3). Arm B: First~     line: irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 and capecitabine 1000 mg/m2~     orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Second line:~     oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3),~     until progression or unacceptable toxicity.~      Patients will be followed by CT-scan every 9 weeks for response while on treatment, or at any~     other moment when progression is suspected. After cessation of chemotherapy, patients will be~     followed every 3 months until death. Clinical and laboratory toxicity/symptomatology will be~     graded according to NCI common criteria.~   "
247610|NCT00311987|"~     The natural thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to have a~     cholesterol-lowering effect. Their pharmacologic use for this purpose is limited, however, by~     their actions on other organs, including the heart, bone, and brain, where there can be side~     effects of excessive thyroid hormone action. 3,5-diiodothyropropionic acid (DITPA) is a~     thyroid hormone analog with relative selectivity for a form of the thyroid hormone receptor~     expressed in the liver, where it regulates several aspects of lipid metabolism, including the~     clearance of low-density lipoprotein (LDL) cholesterol.~      This study is designed to determine whether DITPA is safe and effective in achieving LDL~     cholesterol levels that are consistent with the National Cholesterol Education Program Adult~     Treatment Panel III (NCEP ATP III) guidelines in patients who have not achieved those levels~     on conventional therapy, due to drug-resistant disease, drug intolerance, or both.~      This is a single-center, randomized, double-blind, placebo-controlled study. Following a~     4-week Pre-Randomization Phase with dietary counseling and a 2-week placebo run-in, eligible~     patients will be randomized (1:1:1) to receive DITPA (90 mg/day, 180 mg/day), or placebo for~     a total treatment duration of 12 weeks.~      Sixty (60) patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 20~     patients per treatment group):~        -  DITPA at 90 mg/day (45 mg twice a day [BID] taken orally)~        -  DITPA at 180 mg/day (90 mg BID taken orally)~        -  Placebo (BID taken orally)~      Those patients randomized to receive DITPA at 90 mg/day will receive 45 mg/day for the first~     2 weeks, followed by 90 mg/day for 10 weeks.~      Those patients randomized to receive DITPA at 180 mg/day will receive 45 mg/day for the first~     2 weeks, followed by 90 mg/day for the next 2 weeks, and then 180 mg/day for 8 weeks.~   "
247611|NCT00311974|"~     We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine~     leads to the activation of the sympathetic nervous system in healthy individuals.~   "
247612|NCT00311961|"~     Treatment with systemic corticosteroids for acute exacerbations of COPD results in the~     improvement of clinical outcomes. The optimal route of administration has not been rigorously~     studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many~     hospitals. Oral administration is more convenient, though, because there is no need for~     intravenous access, less personnel is required for starting and monitoring therapy, and~     material costs are smaller.~      The investigators hypothesized that oral administration is not inferior to intravenous~     administration of prednisolone in the treatment of patients hospitalized for an acute~     exacerbation of COPD.~   "
247613|NCT00311948|"~     The purpose of this study is to look at both the clinicians' ability to reach out to the teen~     smokers and to evaluate the efficacy of providing tobacco cessation support using a proactive~     telephone quitline combined with an interactive Web-based program for teens within a managed~     care environment.~   "
247614|NCT00311935|"~     This study will determine whether laparoscopic and open hernia repair have the same~     recurrence and complication rates in the under 60yr old age group. The overall financial~     costs of each repair will also be compared.~   "
247615|NCT00311922|"~     The aim of this research will be to perform a randomized controlled trial (RCT) of a new~     diabetes educational intervention that teaches self-management skills that compensate for~     poor numeracy skills among a sample of patients with diabetes and low numeracy.~   "
247616|NCT00311909|"~     The purpose of this study is to determine whether deep brain stimulation is effective at~     reducing tic frequency and severity in adults with Tourette syndrome.~   "
247617|NCT00311896|"~     The purpose of this study is to evaluate the efficacy and safety of the subcutaneous~     administration for 45 days of Bemiparin (3,500 UI/day) in cancer patients with a CVC, to~     prevent CVC-related deep venous thrombosis (CVC-DVT)~   "
247618|NCT00311883|"~     Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis~     before and after a 4 week course of oral hydroxychloroquine.~   "
247619|NCT00311870|"~     The aim of the study was to compare the renoprotective effect of a long acting calcium~     antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type~     1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to~     treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and~     urinary excretion of albumin were measured every 6 months~   "
247620|NCT00311857|"~     GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ~     from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should~     safety be proven, the phase II trial will be initiated with the standard dose of 75mg/m2 of~     TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1,~     thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this~     phase I/II trial.~      Primary endpoints are feasibility and toxicity, secondary endpoints are overall and~     progression-free survival. An interim analysis will be performed after inclusion of 15~     patients into the main study. Patients’ enrolment will be performed over a period of 2 years.~     The observation time will end 2 years after inclusion of the last patient.~   "
247621|NCT00311844|"~     This study was a double-blind, placebo-controlled, cross-over, single-center study of~     desloratadine 5 mg or placebo in subjects 18 years of age or older with a history of seasonal~     allergic rhinoconjunctivitis. This study was performed to examine the effects of~     desloratadine compared with placebo, on the signs and symptoms of allergic conjunctivitis~     induced by direct conjunctival challenges with a previously identified sensitizing antigen,~     in the eyes of a subject known to be sensitive to the antigen.~   "
247622|NCT00311831|"~     The purpose of this study is to determine whether the caregivers of children presenting to~     the emergency department (ED) with acute gastroenteritis who receive extensive~     gastroenteritis education (standard education plus home nursing visit) will improve their~     gastroenteritis knowledge more than those who receive standard education (an information~     sheet) in the emergency department.~   "
247623|NCT00311818|"~     Primary objective:~        -  To compare efficacy of oral antidiabetics (OAD) combination therapy with either HOE901~          insulin analogue once daily or Lispro insulin analogue at mealtime in terms of change in~          HbA1c (baseline to endpoint).~      Secondary objectives:~        -  To compare the OAD combination therapy with either HOE901 insulin analogue once daily or~          Lispro insulin analogue at mealtime in terms of efficacy and safety.~   "
247624|NCT00311805|"~     The goal of the study is to determine the safety and possible effectiveness of various doses~     of autologous (one's own) stem cells, delivered with a needle into the regions of the leg~     with poor blood flow in patients with blocked leg arteries that results in claudication (pain~     when walking). Stem cells are primitive cells produced by the bone marrow that can develop~     into blood cells or other types of cells. In addition to determining whether this new~     approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of~     this approach for treating intermittent claudication - the condition where areas in the leg~     are lacking enough oxygen and blood flow to keep the leg muscle working well, causing pain~     and cramping upon walking.~      This study is a double-blind, randomized study to compare CD34-positive stem cells versus a~     placebo agent (salt water solution known as normal saline). The patient will have a 3:1~     chance of their stem cells versus the placebo. Regardless of a patient receiving placebo or~     treatment, all patients will undergo all of the pre-treatment phases of this study, which~     includes the stem cell mobilization and apheresis procedure.~   "
247625|NCT00311792|"~     The purpose is to determine if skills obtained by training in the laparoscopic virtual~     reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as~     improved score in a technical skills assessment.~   "
247626|NCT00311779|"~     The primary objective of the study is to determine the safety and efficacy of different~     strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have~     been infested with at least a mild case of Pediculosis capitis (head lice).~   "
247627|NCT00311766|"~     The purpose of this study is to investigate a treatment to enhance the healing of acute and~     chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with~     Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source -~     FDA Office of Orphan Product Development (OOPD).~   "
247628|NCT00311753|"~     Acutely ill immobilized patients are at a high risk for thromboembolic events including deep~     venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular~     weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This~     study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH~     certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.~   "
247629|NCT00311740|"~     The purpose of this study is to compare the effect of the fixed combination of~     valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ~     alone and whether the combination treatments are safe and well tolerated. The study aims to~     establish a dose response relationship for both monotherapies and the combinations.~      This study is being conducted in Japan.~   "
247630|NCT00311727|"~     This study may determine whether laboratory studies of people's blood cells, who have~     received vaccines against H5 influenza, or bird flu, will help to decide if the vaccines~     are going to be prevent disease effectively. About 232 people, 18 years and older, enrolled~     in the studies A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging~     Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated~     Influenza A/H5N1 Vaccine in Healthy Adults and in Healthy Elderly Adults will participate.~     Participants may be involved in this study for about 14 months. Procedures may include blood~     draws, physical exams, and medical history reviews.~   "
247631|NCT00311714|"~     This study will look at the safety, tolerability and what the body does to CS-8958 given to~     40 healthy volunteers 18-55 years old. CS-8958 is a dry-powder investigational drug that is~     breathed into the lungs through an inhaler device. The researchers will collect information~     about any problems that volunteers have while taking the drug and about changes in blood~     pressure and how the heart is working. Volunteers will have breathing tests, physical~     examinations, and blood samples collected for laboratory tests. The researchers will also~     look at how much of the medication travels throughout the body versus how much stays only in~     the lungs. Doses of the medication will be tested at one level and then at higher and higher~     levels after a safety committee reviews the safety and tolerability information on volunteers~     prior to the next higher dose being given. Each volunteer will participate for up to 6 weeks~     from initial screening to the follow up visit and spend 7 days in the clinic.~   "
247632|NCT00311701|"~     This retrospective study conducted in Canada and the US involves a chart review to assess the~     safety of oseltamivir (Tamiflu®) compared to alternate antiviral therapy, amantidine or~     rimantidine, administered to children less than 12 months of age with diagnosed or suspected~     influenza. The objectives are to describe the frequency of neurological and all other adverse~     events possibly related to administration of these antivirals in these infants. Investigators~     will also compare frequency of adverse events at various doses of oseltamivir in these~     children. Critical endpoints to be collected include frequency and severity of adverse~     events, particularly those relating to central nervous system complications. A~     sub-investigator will travel to each of the participating sites to collect data related to~     each infant's health prior to becoming ill, health status at time of influenza diagnosis,~     dosing regimen, reported neurological events post-dosing, and all reported adverse events~     post-dosing.~   "
247633|NCT00311688|"~     Interleukin-2 (IL-2) is a protein found naturally in the blood that helps boost the immune~     system. The purpose of this study is to provide long-term treatment and monitoring of HIV~     infected people enrolled in NIAID-funded studies investigating the use of laboratory-made~     IL-2 for the treatment of HIV infection.~   "
247634|NCT00311675|"~     The purpose of this study is to see how antibodies (proteins that fight infection) are made~     after you receive the new H5N1 flu vaccine. The new H5N1 vaccine will be given to 50 healthy~     adult lab workers, aged 18 years and older. Subjects will receive two 90mcg injections (shots~     in the arm) of the vaccine about 1 month apart. Subjects will maintain a memory aid to record~     oral temperature and any response to the vaccine for 7 days after each immunization. Subjects~     will be contacted by telephone 1 to 3 days after vaccination. They will return to the clinic~     on Day 7. Blood will be drawn before each vaccination and on Days 56 and 180. Subjects may be~     involved in the study for about 6 months. It is anticipated that the vaccine will provide~     safe protection against influenza H5N1.~   "
247635|NCT00311662|"~     Overall trial objectives:~        -  Can treatment with tonabersat reduce the number of days with a migraine headache in~          patients who suffer from frequent migraine attacks~        -  How well tolerated is treatment with tonabersat~      The study is based on the hypothesis that the unique mechanism of action of tonabersat will~     inhibit some of the early events in the generation of migraine and so be effective as~     prophylactic treatment~   "
247636|NCT00311649|"~     The purpose of this research is to study side effects and safety of a new H5N1 flu (bird flu)~     vaccine and to look at how well people's immune systems make antibodies to fight infection~     after they get the vaccine. Up to 300 healthy people who are working at Aventis Pasteur H5N1~     virus vaccine production facility in Swiftwater, PA, during the flu season are being asked to~     participate. It is important for vaccine production workers to receive the vaccine in order~     to minimize the risk of this bird flu virus combining with the regular flu virus. Volunteers~     in this study will have a medical screening, 2 vaccinations a month apart, 2 blood sample~     collections (1 before and 1 after the vaccinations to compare), 5 clinic visits, and~     follow-up over 6 months. They will also complete a diary card and to write down their~     temperature once a day and any symptoms they have every day during the week after they get~     their second shot. They will also be asked to write down any drugs or medicines they take.~   "
247637|NCT00311636|"~     RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may~     prevent this from happening.~      PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in~     preventing early menopause in premenopausal women who are receiving chemotherapy for stage I,~     stage II, or stage III breast cancer that has been removed by surgery.~   "
247638|NCT00311623|"~     RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This clinical trial is studying the best dose of sirolimus and to see how well it~     works before surgery in treating patients with advanced localized prostate cancer.~   "
247657|NCT00311376|"~     The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A~     in treating overactive bladder in spinal cord injury or multiple sclerosis patients.~   "
247639|NCT00311610|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~      PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients~     with metastatic colorectal cancer.~   "
247640|NCT00311597|"~     RATIONALE: Extracranial stereotactic radiosurgery may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of extracranial~     stereotactic radiosurgery and to see how well it works in treating patients with solid~     tumors.~   "
247641|NCT00311584|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with~     temozolomide works in treating young patients with recurrent neuroblastoma.~   "
247642|NCT00311571|"~     Microgravity during space flight induces physiological changes that affect astronauts’ health~     and performance. Space flight simulations such as prolonged bed rest can mimic some of these~     changes and provide study conditions that are more accessible than during space flight. The~     European Space Agency, ESA together with the French national space agency, CNES and the~     Japanese national space agency, NASDA are performing extensive studies using long duration~     bed rest.~      Previous studies including several long and short term bed rest campaigns have yielded~     significant medical data on the physiological changes induced by space flight. These data can~     be used to study the effect of countermeasures, methods helping to prevent these~     physiological changes.~      The long duration bed rest, lasting 3 months undertakes a variety of investigations involving~     28 subjects. This study focuses on countermeasures, studying the effect of a bone tissue~     stabilisation medication and resistive exercises to determine their suitability for use~     during long duration stays on ISS.~      The physiological changes recorded during space flight and bed rest mimic those observed in~     some diseases and in the aging process. Significant clinical applications are expected as a~     direct result of this experiment and future equivalent studies.~   "
247643|NCT00311558|"~     RATIONALE: Sodium stibogluconate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Interferon may interfere with the growth of cancer cells.~     Giving sodium stibogluconate together with interferon may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of sodium~     stibogluconate when given together with interferon in treating patients with advanced solid~     tumors, lymphoma, or myeloma.~   "
247644|NCT00311545|"~     RATIONALE: Monoclonal antibodies, such as CNTO 328, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying how well CNTO 328 works in treating patients with~     unresectable or metastatic kidney cancer.~   "
247645|NCT00311532|"~     The primary objective of this study is to estimate the incidence of new-onset valvulopathy,~     determined by baseline and follow-up echocardiograms, in patients with Parkinson's Disease~     who are receiving pergolide as second-line therapy.~      The secondary objective of the study is to estimate the prevalence of valvulopathy, as~     determined by baseline echocardiograms, among all patients who have Parkinson's Disease and~     are being considered for pergolide as second-line therapy.~   "
247646|NCT00311519|"~     The purpose of this research study to test the effectiveness of a study medication to~     increase how fast a solution called lactated Ringer’s is absorbed when put under the skin~     subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a~     human recombinant form of the enzyme. The drug company name for this medication is Hylenex.~     Hylenex was currently an investigational medication at the initiation of the study, but~     received FDA approval during the study. An investigational medication is a medication or~     formulation of a medication that is not approved by the United States Food and Drug~     Administration for use in this country but may be used in studies such as this one.~   "
247647|NCT00311506|"~     This is an observational study to be conducted at approximately 25 sites in the United~     States. Approximately 25 subjects with severe obstructive CF lung disease (FVC <40%~     predicted) will be enrolled.~   "
247648|NCT00311493|"~     The purpose of this study it is to evalutate the persistence of antibodies after a booster~     immunisation with a TBE vaccine for adults~   "
247649|NCT00311480|"~     The present study aims to evaluate safety and immunogenicity of two doses, administered three~     weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1~     influenza antigen, in non-elderly adult and elderly subjects.~   "
247650|NCT00311467|"~     Multi-center, prospective randomised phase III study evaluating capecitabine in combination~     with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in~     patients with metastatic renal cell carcinoma.~   "
247651|NCT00311454|"~     The study is required by the FDA as part of a post-marketing commitment. The purpose of the~     study is to compare the reactivity of the TRUE Test quaternium-15 patch and a real use~     exposure.The subjects will wear the patch test for 48 hours and reading will be performed day~     3 or 4. The use test will be applied from day 3 or 4 and untill reaction appears. Reactions~     from respectively TRUE Test and use test will be compared using the McNemar Change Test.~   "
247652|NCT00311441|"~     The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE~     vaccines administered to children.~   "
247653|NCT00311428|"~     This phase IV protocol is designed to evaluate the safety, clinical tolerability and~     immunogenicity of the 2005-2006 formulation of three widely used conventional influenza~     vaccines in children aged 6 to 35 months~   "
247654|NCT00311415|"~     Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C~     Conjugate Vaccine in healthy children~   "
247655|NCT00311402|"~     Phase III study to compare the preventive effect of recurrent brain infarction and safety of~     Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic~     acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily~   "
247656|NCT00311389|"~     The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a~     combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.~   "
247658|NCT00311363|"~     The primary objective of this trial is to assess the maintenance of efficacy of gabapentin~     enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering~     from Restless Legs Syndrome (RLS).~   "
247659|NCT00311350|"~     This is the first multiple-dose experience in humans with MOA-728 in an oral formulation.~     This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK)~     of MOA-728 following administration of ascending multiple oral doses to healthy subjects.~   "
247660|NCT00311337|"~     Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and~     tolerability, as well as the efficacy, of maintenance treatment with VELCADE (bortezomib) in~     patients with multiple myeloma with detectable disease activity following tandem high-dose~     chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment~     will be 3 to 6 months.~   "
247661|NCT00311324|"~     The purpose of this study it to determine if a culturally appropriate, church based~     intervention for African Americans with type 2 diabetes, will lead to improved glycemic~     (blood sugar) control.~   "
247662|NCT00311311|"~     The purpose of this study is to determine whether immunosuppression by tacrolimus,~     mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate~     mofetil, and prednisone affect the progression of atherosclerosis in renal transplant~     recipients.~   "
247663|NCT00311298|"~     We propose a randomised trial among pulmonary TB patients, examined and treated as part of~     the national TB control programme (WHO, 2003). The aim is to improve TB treatment outcome in~     high TB and HIV burden countries. The overall objective of the proposed trial is to assess~     the effect of nutritional support on TB treatment outcomes, and to assess the role of~     diabetes on risk and severity of TB, and TB treatment outcomes. The study will be conducted~     in Mwanza Tanzania. All patients will initially be examined for HIV and diabetes. A total of~     500 found pulmonary TB smear-positive (PTB+) and HIV positive (HIV+) will be randomised to a~     daily supplement of 1 versus 6 energy-protein bars throughout treatment, both with full~     multi-micronutrient (MN) content. A total of 1500 found pulmonary TB smear-negative (PTB-,~     irrespective of HIV status) and PTB+ and HIV negative (HIV-) will be randomised to 1 daily~     energy-protein bar containing either low or high MN content.~   "
247664|NCT00311285|"~     The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more~     demanding because of the challenge of operating through small scars in the abdominal wall~     without any tactile feedback depending only on the visual feedback on a monitor. The purpose~     is to establish a model of how to measure mental and physical load in laparoscopy.~   "
247665|NCT00311272|"~     Dendritic cells loaded with tumor antigens induce cytotoxic T-cells which have been proved~     capable of killing both melanoma and breast cancer cells. Melanoma and colorectal cancer~     cells express some common antigens. Hence it is possible to use melanoma lysate to load the~     dendritic cells with tumor antigens similar to the antigens expressed by the patients'~     colorectal cancer cells.~      The patient receives 10 vaccinations with 14 days between each. The parameters for effect are~     changes in tumor/metastasis size measured with computed tomography (CT), decrease in serum~     concentration of carcinoembryonic antigen (CEA), performance status measured by the World~     Health Organization (WHO) criteria, and Quality of Life.~   "
247666|NCT00311259|"~     The purpose of this study is to determine whether treatment with melatonin can reduce cell~     damage and inflammation in connection with laparoscopic gall bladder surgery.~   "
247667|NCT00311246|"~     Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by~     the buildup of immune-system (fights off infection in the body) cells in organs. These cells~     form small groups called granulomas, which lead to inflammation of the surrounding tissue.~     Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system).~     The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs~     in many patients can include redness and painful lumps on the skin, reduced eyesight, joint~     pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged~     adults.~      There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid~     hormone) therapy is considered the standard treatment. Only limited benefit has been shown~     when using corticosteroid therapy to ease lung symptoms or improve lung function in patients~     with sarcoidosis. Also, the effects of other therapies (for example: methotrexate,~     cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that~     suppress a body's natural defense system [immune system]) which have been used in a small~     number of patients are not well known and can cause long term problems.~      The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug~     Administration) approved for patients with moderately to severely active rheumatoid~     arthritis. However, adalimumab is not approved for the treatment of sarcoidosis. Adalimumab~     is experimental in this study. The purpose of this study is to evaluate the safety and~     effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary~     (lung) involvement who show symptoms of the disease even though they are currently being~     treated with medication.~   "
247668|NCT00311233|"~     Recurrent abdominal pain (RAP) is a common complaint in childhood. Identification of the~     processes that maintain illness is important.~      The purpose of this study is to get more knowledge about characteristics of children with~     recurrent abdominal pain and their parents, and about the course of their pain. These results~     may be important to identify children who need treatment.~   "
247684|NCT00311025|"~     The purpose of this project is to follow first-ever- acute stroke patients from onset, one,~     two and four years post stroke and study the effect of two different approaches of exercises~     implemented the first year post-stroke.~   "
247685|NCT00311012|"~     This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with~     essential hypertension.~   "
247686|NCT00310999|"~     Patients undergoing surgery will have laryngoscopy performed using two widely accepted~     techniques – Macintosh Laryngoscope and Shikani Optical Scope. The techniques will be timed~     and compared for cervical spine movement using fluoroscopy.~   "
247720|NCT00310557|"~     The purpose of this study is to look at the safety (what are the side effects) and efficacy~     (how well does it work) of Magnevist (the study drug) used for MRI of the renal arteries. The~     results will be compared to the results of MRI taken without Magnevist and with the results~     of your X-ray angiography.~   "
247669|NCT00311220|"~     Tuberculosis is still the most common infectious disease in Taiwan. The infants in Taiwan~     have been vaccinated at birth with BCG -Tokyo 171 strain since 1951. The BCG vaccination rate~     is 97% among first grade students in a recent national survey. Even with such a high BCG~     vaccination coverage, Taiwan still has a relatively high TB incidence rate. In 2004, there~     were totally 16,784 newly diagnosed TB cases and the annual incidence was 74.11 per 100,000~     population nationally. Nearly 70% of the incidence cases were men and 30.4% were women. The~     mean age of incidence cases was 57.8 years old (median=63). 8,440(50.29%) patients were~     elderly than 65 years old. The elderly men did not receive the BCG vaccination and were the~     most important group to develop newly diagnosed tuberculosis and a special issue for the~     national TB control program in Taiwan.~      The tuberculin skin test (TST) is the only widely available method for detecting whether~     people have an immunologic reactivity to mycobacterial antigens and identified as latent~     tuberculosis infection (LTBI). Targeted tuberculin testing for latent TB infection is a very~     important strategy to identify subjects with high risk to develop tuberculosis including~     those who have recent infection with Mycobacterium tuberculosis or have clinical conditions~     that associated with an increased risk for progression of LTBI to active TB but the~     sensitivity was lower in elderly patients.~      Quantiferon-TB gold test (QFT-RD1) is a new diagnostic test for latent tuberculosis and a~     valuable alternative to skin testing. This whole-blood assay measures the production of IFN-~      in whole blood upon stimulation by ESAT-6 and CFP-10 and allows distinction of latent M.~     tuberculosis infection from BCG-induced reactivity. ESAT-6 and CFP-10 are deleted from BCG~     Region 1 (RD1), not present in most nontuberculous mycobacteria and are highly specific~     indicators of M. tuberculosis infection. Thus, the aim of this study was to estimate the~     specificity and sensitivity of a whole blood IFN-γassay employing CFP-10 and ESAT-6, for the~     detection of M. tuberculosis infection in a clustered high risk elderly population.~      Changhwa Veterans Home is a government-expense veterans home with totally 519 residents in~     2004.The inhabitants were all elderly people and lived in groups. , They did not receive BCG~     vaccination and were the high risk group to develop endemic TB infection. The annual TB~     incidence rate over there was 3,500 per 100,000 population.~   "
247670|NCT00311207|"~     Pulmonary tuberculosis is one of the most important infectious diseases in human with high~     mortality.~      Early diagnosis followed by antibiotic treatment is the only way for control of the disease.~     However, most of commercial tuberculosis diagnostic kits are of moderate sensitivity.~     Oncoprobe Inc. recently developed a tuberculosis diagnostic kit (HR-103) based on detection~     of antibody against Mycobacterium tuberculosis in serum. The main purpose of this project is~     to evaluate the sensitivity and specificity of the kit in detection of pulmonary tuberculosis~     from saliva, urine, pleura and serum samples.Capilia TB assay and another~     Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based~     immunochromatographic assay will be tried to detection tuberculous disease.~   "
247671|NCT00311194|"~     The purpose of this study is to determine whether extra education of patients with chronic~     heart failure can reduce 6 months readmission rate to hospital.~   "
247672|NCT00311181|"~     The objective of this study is to compare the ULV (Upper Limit of Vulnerability)/DFT~     (Defibrillation Threshold) efficacy between the 2.5, 3.5 and 4.5 ms membrane time constant~     based biphasic defibrillation waveforms. This comparison will result in identifying the~     optimal membrane time constant when programming the tuned defibrillation waveform.~   "
247673|NCT00311168|"~     The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual~     chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with~     implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV~     delay.~   "
247674|NCT00311155|"~     This study is to assess the safety and efficacy of an add-on treatment algorithm with~     olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate~     hypertension.~   "
247675|NCT00311142|"~     The development of regular sleep-wake cycle is an important factor of the newborn maturation~     and it has influence on behavior .Factor that may influence the process of the maturation of~     the sleep-wake cycle is the delivery mode.nd growing. These various states could be detected~     and measured with actigraphy, using a wrist-watch like device that continuously measures and~     records the subject's movements.The present study aims to compare vacuum delivery with~     regular, elective and not elective caesarean sections. We hypothesize that the sleep of~     vacuum-delivered newborns will be more fragmented then newborns in other delivery modes.~   "
247676|NCT00311129|"~     The purpose of this study is to assess the antitumor effect and safety of fludarabine~     phosphate tablet in combination with rituximab in patient with indolent lymphoma.~   "
247677|NCT00311116|"~     The primary objective is to determine whether in children undergoing doxorubicin-containing~     chemotherapy, if topical vitamin E, when compared to placebo, decreases an objective~     measurement of oral mucositis.~   "
247678|NCT00311103|"~     Objectives: To assess the efficacy of an intervention program targeted to the elderly with~     recent-onset disability of musculoskeletal origin (DIMS), and to perform its economic~     evaluation.~   "
247679|NCT00311090|"~     The three purposes of this study are the following:~        -  To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux~          (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep~          venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;~        -  To compare the activities of idrabiotaparinux and idraparinux directly in blood during~          and after a 6-month treatment;~        -  To check the ability of avidin (SSR29261) to reverse the blood thinning activity of~          idrabiotaparinux at the end of a 6-month treatment period.~   "
247680|NCT00311077|"~     Primary objective~        -  To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration~          of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin~          glulisine across healthy subjects in 4 different BMI-classes (lean, overweight,~          moderately obese, severely obese), using the euglycemic clamp technique with the~          Biostator™.~      Secondary objective~        -  To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous~          administration of insulin glulisine in comparison to insulin lispro and to investigate~          the safety and tolerability after subcutaneous administration of insulin glulisine in~          comparison to insulin lispro.~   "
247681|NCT00311064|"~     Purpose:~      The purpose of this study is to determine if disturbances in cytokines or factors of the~     metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period~     in pregnant women with type 2 diabetes or who are overweight. At the same time we, the~     investigators at Rigshospitalet, want to determine if physical activity in the overweight~     pregnant woman can influence these factors in a favourable way and, with that, improve the~     progress of pregnancy and birth.~   "
247682|NCT00311051|"~     The purpose of this study is to examine wether the combination of Ramatroban/Montelukast is~     as effective as Montelukast alone in patients with mild to moderate atopic asthma (GINA I and~     II) sensitive to house dust mite. The test is performed by a specific inhalative provocation.~   "
247683|NCT00311038|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients~     scheduled for multi-slice CT.~   "
247687|NCT00310986|"~     In 2004, the Developmental Clinic of the Child Psychiatric Unit at Srinagarind Hospital, had~     80 new pediatric cases of attention deficit hyperactivity disorder (ADHD) come for evaluation~     and intervention. The children were between 7-12 years of age. Most of them were treated with~     stimulant medication, (i.e. methylphenidate) to help reduce hyperactivity; however, both the~     parents and children needed special help to develop some techniques for behavioural~     management.~      Meditation has been used as an attention training method for many thousands of years, and was~     mostly involved with religious or spiritual practices in various parts of the world,~     especially in the eastern countries. Breathing meditation is a popular method which can be~     applied to all people without instructions that are too complicated. If meditation therapy,~     by breathing meditation which is specified to treat attention deficit hyperactivity~     disorders, benefits this group of patients, it would be very useful, culturally appropriate,~     cost-effective and would reduce the drugs used which will save the child from drug side~     effects.~   "
247688|NCT00310973|"~     This study will evaluate the effectiveness of peer-led HIV/sexually transmitted disease~     (STD)risk reduction educational counseling in reducing HIV risk behavior among the social~     networks of young men who have sex with men and Roma men and women in Bulgaria and Hungary.~   "
247689|NCT00310960|"~     The purpose of this study is to:~        -  To estimate the duration of misalignment by age at presentation in infantile esotropia~          (infantile ET), acquired non-accommodative esotropia (ANAET) and acquired partially~          accommodative esotropia (APAET).~        -  To determine the proportion of patients with angle instability in infantile ET, ANAET~          and APAET by length of follow-up.~   "
247690|NCT00310947|"~     Complete normalization of CFR following AVR for aortic stenosis was observed only for~     stentless valves. Besides the superior hemodynamic performance this might explain the~     excellent long term results of this valve design.~   "
247691|NCT00310934|"~     The objective of this study is to compare optimally given methadone maintenance treatment~     (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered~     buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to~     methadone if the maximal dose of buprenorphine is insufficient.~   "
247692|NCT00310921|"~     The purpose of this study is to determine whether misoprostol administered prior to elective~     first trimester pregnancy has an effect on pain and ease of procedure and complications.~   "
247693|NCT00310908|"~     The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a~     non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute~     renal colic.~   "
247694|NCT00310895|"~     The purpose of this study is to determine the safety and the maximum tolerated dose of~     GRN163L administration in treating patients with refractory or relapsed solid tumor~     malignancies.~   "
247695|NCT00310882|"~     The endogenous digitalis-like compounds (DLC)are steroid hormones synthesized and released~     from the adrenal gland.They are integrated in the feed-back system of the~     Hypothalami-Pituitary-Adrenal gland axis.One of their remarkable function is to induce~     apoptosis in malignant cells. Recently, accumulating data point to the possibility of using~     synthetic DLC as new anti-cancer drugs. Less is known about the endogenous metabolism of~     these compounds in cancer patients.~      Proceeding from preliminary clinical data which demonstrated significantly reduced DLC plasma~     levels in breast cancer patients and from in vitro data which showed an impaired release of~     DLC towards stress stimuli in athymic nude mice,we put up the hypothesis that a latent~     adrenal insufficiency with low DLC levels facilitates the induction and progression of tumor~     diseases.~   "
247696|NCT00310869|"~     This research study is a long-term follow-up to an earlier study of developmental care. For~     that study, high risk preterm newborns were randomly assigned to a standard care group, which~     received the standard care offered in the Newborn Intensive Care Unit (NICU) at the time, or~     to an experimental group, which received regular behavioral observations to determine if~     changes in their environment or care were needed. The purpose of the current study is to~     assess the functioning of these infants again, now that they are adolescents and to compare~     the groups to determine if the developmental care used in the original study is effective~     long-term.~   "
247697|NCT00310856|"~     To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate~     vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.~   "
247698|NCT00310843|"~     Attempt to identify genetic polymorphisms in interrogated pathways which may be associated~     with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within~     the first 8 weeks of nevirapine therapy.~   "
247699|NCT00310830|"~     The study will assess the effect of bosentan on pulmonary vascular resistance and exercise~     capacity in sickle cell disease (SCD) patients diagnosed with pulmonary arterial~     hypertension. It consists of 3 phases: Screening, Treatment and Follow-up. During the~     Screening visit, the study doctor will decide if patients meet the study requirements. All~     potential patients will have a diagnosis of increased pulmonary artery pressures that is~     shown by right heart catheterization conducted shortly prior to start of study treatment.~     Patients will be asked to perform exercise capacity test (walking as far as possible for 6~     minutes). Following the Baseline visit, the treatment phase consists of 4 additional clinic~     visits during which the good and bad effects of the drug are reviewed and exercise capacity~     test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected~     every month, or more often, if needed. At the end of the study, patients will be asked to~     repeat the right heart catheterization and exercise capacity test. After completion of the~     study, patients will have the option of enrolling in a long-term follow-up study where all~     patients will receive active drug. Patients electing not to participate in the extension~     study will be followed up for safety assessments for about 28 days after the end of the study~     treatment.~   "
247700|NCT00310817|"~     To compare the functional immune response 28 days after administration of one dose of Men~     ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY~     polysaccharide (PS) vaccine~   "
247701|NCT00310804|"~     The present study aims to evaluate safety, tolerability and immunogenicity of three lots of~     Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a~     conventional egg-derived control vaccine licensed in Europe.~   "
247721|NCT00310544|"~     The purpose of this study is to determine the dose of drug which is most effective in the~     delineation of dead heart muscle.~   "
247702|NCT00310791|"~     This study seeks to gain new information on why young women with anorexia nervosa are~     predisposed to early bone loss and osteoporosis. Through a randomized treatment trial in~     which participants will receive either combined therapy with the adrenal hormone,~     dehydroepiandrosterone (DHEA) and estrogen replacement therapy or placebo, we will determine~     the effects of an 18-month treatment course on bone mass, circulating markers of bone~     turnover, and serum levels of a factor, insulin-like growth factor I (IGF-I). We are also~     studying if these therapies change bone structure to increase skeletal strength compared to~     placebo, as assessed through cross-sectional geometric analysis of our bone density data by~     dual-energy x-ray absorptiometry (DXA).~   "
247703|NCT00310778|"~     The impact of sodium intake on plasma drug concentrations has previously been reported in the~     literature for verapamil and quinidine but, to the investigators' knowledge, never with~     renin-angiotensin system blockers such as AT1R antagonists and angiotensin converting enzyme~     inhibitors.~   "
247704|NCT00310765|"~     The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in~     abdominal pain from adhesions.~   "
247705|NCT00310752|"~     The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the~     management of chronic wounds.~      Other goals of this study are to gain feedback from patients and healthcare providers on the~     ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the~     efficacy of DermaStream(tm) in chronic wound management.~   "
247706|NCT00310739|"~     We previously reported early measurement of urinary MDA might be a useful marker for the~     prediction of CDDP-induced renal damage in rat. The purpose of this clinical study is to test~     whether the changes of human urinary excretion of MDA, and can be used as early biomarker for~     the prediction of development of CDDP-induced ARF.~   "
247707|NCT00310726|"~     The study is designed as a randomized, controlled trial with specific observational~     objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be~     counselled to exclusively breastfeed through 4 months of age. All live-born children will be~     randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning~     at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with~     the introduction of typical weaning foods ad lib.~   "
247708|NCT00310713|"~     Persistence of antibodies and kinetics of B cell response in healthy children after~     vaccination with MCC vaccine~   "
247709|NCT00310700|"~     Kinetics of B cell response in infants Menjugate vaccination~   "
247710|NCT00310687|"~     Persistence of Immune response after vaccination with MCC~   "
247711|NCT00310674|"~     Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine~     Administered to Healthy Premature and Non Premature Children of 3 months of age~   "
247712|NCT00310661|"~     TD is a troublesome and potentially irreversible side effect associated with the use of~     neuroleptics. While the newer neuroleptics are improved in this regard, they all still carry~     the risk of TD.~      The present study proposes that sarizotan is a potential agent for treating~     neuroleptic-induced TD based on preliminary data indicating efficacy in the management of~     dyskinesias associated with Parkinson's disease. Its efficacy is further substantiated by~     pre-clinical data obtained from the vacuous chewing movement (VCM) model in rats, a model we~     employ ourselves in investigating the relationship between D2 occupancy and TD. The present~     study also examines the effects of sarizotan on cognitive function, given the association~     between TD and cognitive deficits.~   "
247713|NCT00310648|"~     Clinical Trial in Two parts:~      Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted~     Influenza Vaccine When Administered to Elderly Subjects.~      Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate~     the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When~     Administered to Elderly Subjects.~   "
247714|NCT00310635|"~     Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32~     to 40 Months of Age~   "
247715|NCT00310622|"~     The purpose of the study is to verify the ability of the HyperQ signal to detect Dobutamine~     induced Ischemia. The gold standard for ischemia will be the results of Angiography if~     performed, or Echocardiographic imaging, which was performed during the test.~   "
247716|NCT00310609|"~     The purpose of this study is to look at the safety (what are the side effects) and efficacy~     (how well does it work) of Magnevist (the study drug) used for MRI of the aortic arch and~     cerebral branches. The results will be compared to the results of MRI taken without~     Magnevist, and with the results of your X-ray angiography.~   "
247717|NCT00310596|"~     The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine)~     injection has on the way the heart conducts the electrical impulses that allow it to beat~     effectively. The study will compare Magnevist injection's effect to that of placebo (a saline~     injection).~   "
247718|NCT00310583|"~     The aim of this randomized placebo-controlled study is to evaluate the effects of analgetics~     for neuropathic pain on mechanical hyperalgesia as a kind of evoked pain. Therefore the~     number of responders and non-responders on pregabalin will be evaluated in respect of~     mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking~     pain determined via pinprick). The hypothesis is that in the placebo group the amount of~     non-responders is increased.~   "
247719|NCT00310570|"~     Stubbing of the finger-tip is a common injury in sports such as basketball, volleyball,~     cricket and football. This can result in a Mallet finger deformity, where the end joint of a~     finger cannot be actively straightened out. In most mallet finger cases seen at The Alfred,~     the skin remains intact, and the impairment results from a tear of the extensor tendon or an~     avulsion (a small fracture where the tendon attaches to the bone). Treatment commonly~     involves immobilising the end joint of the finger in a splint for six or more weeks so~     patient compliance is a major factor in the quality of the outcome achieved.~      This study aims to compare two different types of splintage (the commonly used thermoplastic~     thimble splint and the aluminium-foam “Mexican hat” splint which is in use in Britain) with a~     control splint (thermoplastic prefabricated “stack splint” with tape). Outcome measures will~     include patient compliance with the splint, degree of extensor lag, active movement of the~     joint, and any complications.~      The null hypothesis is that there are no differences in outcome between different methods of~     conservative splinting treatment for mallet finger.~   "
247722|NCT00310531|"~     The aim of this trial is to investigate whether the Menostar patch is as safe and effective~     in the prevention of bone loss in postmenopausal women as raloxifen, a drug already~     registered for prevention and treatment of osteoporosis.~   "
247723|NCT00310518|"~     The purpose of this study is to assess the overall response rate (ORR) of persistent,~     recurrent or metastatic leiomyosarcoma in patients treated with ARQ 501.~   "
247724|NCT00310505|"~     This study is being conducted to assess the safety and efficacy of amphotericin B~     deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given~     in the conventional way every alternate day against the daily administration regimen being~     tested.~   "
247725|NCT00310492|"~     This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment~     of atopic dermatitis~   "
247726|NCT00310479|"~     We seek to develop an advanced imaging approach to identifying and localizing prostate~     cancer. We believe that high field MRI (magnetic resonance imaging) has the potential to do~     this and we will endeavor to prove this by having patients with prostate cancer~     pre-operatively undergo a technique called magnetic resonance spectroscopy. After surgery,~     the microscopic locations of cancer will be compared with the pre-operative images to assess~     how well the imaging technique succeeds.~   "
247727|NCT00310466|"~     The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of~     birch pollen induced allergy~   "
247728|NCT00310453|"~     The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use~     in children aged 5-12 years~   "
247729|NCT00310440|"~     The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not~     inferior in effectiveness and safety to local autologous bone (control device) when applied~     in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural~     allograft ring in patients with degenerative cervical disc disease..~   "
247730|NCT00310427|"~     This study will determine whether the experimental drug LY686017 can reduce a person's desire~     for alcohol. A brain chemical called Substance P acts at places in the brain called NK1~     receptors. Substance P is released in response to stress and gives rise to behaviors that are~     thought to represent anxiety. LY686017 blocks Substance P from acting at the NK1 receptors.~      People between 21 and 65 years of age who have been drinking on a regular basis for at least~     one month before entering the study, who meet the criteria for alcohol dependence and who~     have an elevated score on a general test of anxiety may be eligible for this study.~      Participants are admitted to the NIH Clinical Center for 35 days. They participate in an~     alcohol treatment program in addition to the research study. After having been withdrawn from~     alcohol for at least 2 days, participants receive either 50 mg of LY686017 or placebo (an~     inactive substance that looks like the study drug) every morning for 28 days. In addition to~     drug treatment, they undergo the following procedures:~        -  Functional magnetic resonance imaging (fMRI): In the last week of the study, subjects~          undergo MRI to study the amount of blood going to brain structures thought to be~          involved in anxiety and craving. During the procedure, they look at pictures of faces~          exhibiting various emotions and pictures related to alcohol.~        -  Cue reactivity: At the beginning and towards the end of the study, subjects are asked to~          rate their alcohol craving and their anxiety level while they sniff and handle their~          favorite alcoholic beverage or water.~        -  Metyrapone test: During weeks 1 and 4 of the study, subjects are given metyrapone - a~          drug that interferes with the body's ability to make the stress hormone cortisol - to~          determine how LY686017 affects the body's hormonal response. The drop in cortisol from~          metyrapone administration causes the brain to release ACTH, a hormone that causes the~          adrenal gland to make cortisol.~        -  Trier test: In the last week of the study, subjects give a 5-minute speech to three~          people and are then asked to subtract numbers in their head. Then they are asked to rate~          their feelings and desire for alcohol on two rating scales. Blood is drawn from a saline~          lock at the beginning and end of the test to measure hormone levels.~        -  Rating scales: Subjects complete an Obsessive Drinking Scale weekly and an Alcohol Urge~          Questionnaire and Comprehensive Psychiatric Rating Scale twice a week.~        -  Blood tests: Blood samples are collected periodically to check blood chemistries,~          clotting time, and the amount of LY686017 in the blood.~   "
247731|NCT00310414|"~     This study will examine how the brain makes involuntary spasms and contractions in patients~     with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause~     uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is~     involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study~     which areas of the brain are primarily affected in FHD and better understand how brain~     changes produce dystonia symptoms.~      Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be~     eligible for this study. Candidates are screened with a medical history and physical and~     neurological examinations. Women who can become pregnant have a urine pregnancy test.~      All participants undergo fMRI. This test uses a strong magnetic field and radio waves to~     obtain images of body organs and tissues. The subject lies on a table that is moved into the~     scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that~     occur during the scanning process. The procedure lasts about 90 minutes, during which time~     the patient is asked to lie still for 10-15 minutes at a time. During the procedure, subjects~     are asked to perform some tasks, including writing, tapping with their hand, and drawing in a~     zigzag motion. Each task is performed using the right hand, left hand and right foot.~   "
247732|NCT00310401|"~     The purpose of this study is to test the effectiveness of albuterol versus placebo with the~     following specific aims: a) Treatment of brain dead organ donors with albuterol will reduce~     pulmonary edema, improve donor oxygenation, and increase the number of lungs available for~     transplantation, b) Developing a blood test to predict the development of primary graft~     dysfunction in lung transplant recipients, and c) treating brain dead organ donors with~     albuterol will decrease markers of primary graft dysfunction and lead to improved lung~     transplant recipient outcomes and to higher rates of lungs suitable for transplantation.~   "
247733|NCT00310388|"~     This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind~     VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet~     inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an~     adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation.~     Treatment will be continued until the subject withdraws from the study or until the program~     is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia,~     and South Africa. The primary objective of the study is to evaluate the safety and~     tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult~     epilepsy patients with partial-onset seizures, who completed the double-blind Study~     VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with~     retigabine and patient quality of life and to evaluate whether retinal pigmentation,~     unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of~     nails, lips, skin or mucosa change over time after discontinuation of retigabine.~   "
247777|NCT00309777|"~     The purpose of this study is to compare the efficacy and safety of pitavastatin with that of~     simvastatin.~   "
247734|NCT00310375|"~     The purpose of this study is to evaluate the safety and tolerability of long-term therapy~     with retigabine administered as adjunctive therapy in adult epilepsy patients with~     partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of~     long-term treatment with retigabine and patient quality of life will also be assessed.~   "
247735|NCT00310362|"~     Low endoscopy completion rates are a major problem in the VA, causing delay or failure to~     receive essential care, increased clinic wait times, lost capacity, increased costs, thus~     limiting endoscopic screening for colorectal cancer. This study tests whether an Interactive~     Voice Response (IVR) messaging system is equally effective in promoting the completion of~     flexible sigmoidoscopy and colonoscopy as usual clinical care practices that include phone~     calls from nurses to patients prior to preparation and procedures. Previous studies have~     examined the role of scheduling facilitation or patient adherence on endoscopy completion and~     the use of IVR technology to enhance patient adherence in other medical contexts. This is the~     first study, however, to evaluate the use of IVR for endoscopy completion and the first to~     compare it to the effectiveness of phone calls from nurses prior to an endoscopy appointment.~   "
247736|NCT00310349|"~     PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination~     for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can~     prevent ear disease in infants. Mothers will receive the 23 valent pneumococcal~     polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon~     after child birth; or c) seven months after child birth (control group). The adult~     diphtheria, tetanus and acellular pertussis vaccine (dTPa) will be used as the control~     vaccine for the birth dose.~      The study aims to recruit 210 Indigenous women aged 18-39 years who have an uncomplicated~     pregnancy. Following recruitment, subjects will be randomly assigned to one of the three~     groups.~      Each mother and infant will be followed from pregnancy until the baby is seven months of age.~     Children will receive all of their routinely recommended vaccinations in accordance with the~     standard vaccination schedule.~      The primary outcome will be prevalence of ear infection at seven months of age, defined as~     middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic~     otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary~     analyses will be a direct comparison of the proportion of infants in the control group who~     have nasopharyngeal carriage of vaccine type pneumococci at seven months of age compared to~     infants in each of the other two groups and a similar comparison of the proportion with~     middle ear disease.~   "
247737|NCT00310336|"~     50-60% of patients with chronic hepatitis C are not cured by treatment with pegylated IFNα~     plus ribavirin.~      Retreatment of non-responders of previous (pegylated) IFNα plus ribavirin therapies with~     pegylated IFNα plus ribavirin results in a sustained response in less than 10% of the~     patients.~      Extensive analysis of IFNα signaling in cells expressing HCV proteins, in transgenic mice~     expressing HCV proteins, and in liver biopsies from patients with chronic hepatitis C point~     to STAT1 methylation as an important posttranslational modification targeted by HCV to~     inhibit IFNα signaling.~      STAT1 methylation can be increased and IFNα can be improved by adding AdoMet and betaine.~      The study is designed to test the hypothesis that a combination treatment with pegylated~     IFNα2b, ribavirin, AdoMet and betaine is superior to the current standard combination therapy~     with pegylated IFNα plus ribavirin.~   "
247738|NCT00310323|"~     The purpose of this research study is to determine the effect of chronic nighttime low oxygen~     saturations on selected body systems (liver) that break down drugs in children with~     obstructive sleep apnea syndrome (OSAS).~   "
247739|NCT00310310|"~     Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with~     serious medical and psychological complications. Nasal continuous positive airway pressure~     (CPAP) is the treatment of choice for this condition because it is highly effective in~     reducing the frequency of nocturnal respiratory events, improving sleep architecture,~     decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence,~     however, limits the effectiveness of CPAP therapy and results in sub-optimal patient~     outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest~     improvements, have generally not been theory-driven, and have had minimal effects on key~     patient outcomes such as reduction in OSA symptoms or increase in health-related quality of~     life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management~     Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that~     requires significant self-care on the part of the patient. We draw on the extensive chronic~     disease self-management literature to provide a solid theoretical justification for this~     pragmatic intervention both to better manage key aspects of OSA and to increase CPAP~     adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve~     treatment adherence, and decrease medical utilization.~   "
247740|NCT00310297|"~     Primary objective:~      To compare the pharmacodynamics of insulin glulisine and insulin lispro injected~     subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects~     with type 2 diabetes.~      Secondary objectives:~        -  To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese~          subjects with type 2 diabetes, injected subcutaneously before three standard meals~          during a 12-hour day.~        -  The safety of insulin glulisine, the relationship of the pharmacodynamics and~          pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid,~          triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.~   "
247741|NCT00310284|"~     The purpose of this study is to determine whether a handheld computer is superior to a~     self-help manual for the treatment of chronic primary insomnia.~   "
247742|NCT00310271|"~     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where~     administrations are given and any effects it may have on subjects' wellbeing. The study will~     also test the ability of vaccine to cause particular immune responses in the body.~   "
247778|NCT00309764|"~     The overall objective of this study is to improve clinical outcomes and quality of life for~     congestive heart failure (CHF) patients by integrating a readily available, low cost~     technology – the telephone – into coordinated CHF care.~   "
247779|NCT00309751|"~     The purpose of this study is to compare the efficacy and safety of pitavastatin with that of~     atorvastatin in patients with type II diabetes mellitus (type II DM) and combined~     dyslipidemia.~   "
247743|NCT00310258|"~     This study will develop and test drug use prevention strategies for low-income, minority~     girls. Gender-specific substance use rates, risk and protective factors, and health outcomes~     highlight the need for interventions aimed at girls. Girls and boys share a number of risk~     factors, yet some factors are more salient for one gender. Girls and boys may also be~     affected differently by the same risk factors. Intervention planned for this study emphasizes~     risk and protective factors that impact girls. Our intervention will build mother-daughter~     communication and closeness; enhance girls' self-efficacy and body esteem; nurture girls'~     conflict management, problem-solving, stress reduction, and refusal skills; correct perceived~     norms; build social supports; and establish patterns of parental monitoring and supervision.~     We hypothesise that girls who receive GSI will have lower 3-year follow-up rates of substance~     use than girls who receive no intervention.~      The study will occur in three phases. In a 12-month preparation phase, we will refine and~     complete intervention and measurement protocols, recruit subjects and randomly assign girls~     and mothers to study arms, and pretest girls and mothers. A 12-month implementation phase~     will initiate field operations of the clinical trial, including intervention delivery,~     process data collection, and posttests. Follow-up in the last 36 months will involve~     longitudinal measurements of girls and mothers, booster session development and delivery, and~     data analyses.~   "
247744|NCT00310245|"~     This is a single center, independent study. The primary objective is to compare efficacy and~     safety of continuing a conventional HAART in chronically infected HIV patients with a~     therapeutic strategy based on long term, immunologically driven treatment interruptions.~     Evaluation will be based on clinical, immunological and virological response.~      Patients will be randomized in a ratio 1:2 to one of the two treatment arms:~      Control group continuing the ongoing therapy STI group performing long term CD4 guided~     structured treatment interruptions In the STI arm patients will stay off therapy until their~     CD4 count will drop < 400 cells/mcL. At that time point patients will resume the HAART~     regimen they were assuming before STI and will continue HAART until they CD4 count will raise~     > 800 cells/mcL and their HIV-RNA will drop below the detection limit of 50 copies/ml. When~     both the CD4 count and the viral load will be within these pre-set values they will stop~     therapy again. There is no limit to the number of interruptions and re-start cycles during~     the study period The study is powered to evaluate equivalence between the two strategies~     under the assumption of a failure proportion in the control arm at each time point not~     greater than 5% and a maximum allowed difference of 15%.~   "
247745|NCT00310232|"~     The general objective of this study is to improve the Quality of Life (QoL) of selected~     patients with advanced carcinoma of the lung. The specific objective is to evaluate the~     effect of treatment with epoetin alfa (recombinant human erythropoietin) on anemia related~     QoL and anemia in non-small cell lung cancer patients with advanced stage disease and~     underlying anemia of malignancy.~   "
247746|NCT00310219|"~     RATIONALE: Imaging procedures, such as positron emission tomography (PET) scan and CT scan,~     may help doctors plan radiation therapy for patients with non-small cell lung cancer.~      PURPOSE: This clinical trial is studying how well a combined PET scan and CT scan works~     compared to a CT scan alone in planning radiation therapy for patients with stage II or stage~     III non-small cell lung cancer.~   "
247747|NCT00310206|"~     The purpose of this research study is to compare how the body reacts to different strengths~     of an H5N1 flu vaccine when given by different routes of injection (injection into the skin~     or into the muscle). It will also compare how antibodies (proteins produced by the body's~     immune system that recognize and help fight infections and other foreign substances in the~     body) are made after receiving the H5N1 flu vaccine. Participants will include 100 healthy~     adults, ages 18-40 years. Study procedures include blood samples and completing a memory aid~     documenting daily oral temperature and side effects for 7 days following each vaccination.~     Participants may be involved in the study for up to 13 months.~   "
247748|NCT00310180|"~     This randomized phase III trial studies the best individual therapy for women who have~     node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype~     DX), and whether hormone therapy alone or hormone therapy together with combination~     chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen~     can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by~     blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the~     body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving hormone therapy together with more than one chemotherapy drug (combination~     chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the~     benefit of adding chemotherapy to hormone therapy for women with node-negative,~     estrogen-receptor positive breast cancer is small. New tests may provide information about~     which patients are more likely to benefit from chemotherapy.~   "
247749|NCT00310167|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet~     known which regimen of low-dose radiation therapy is more effective in treating follicular~     non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying two different regimens of low-dose~     radiation therapy (24Gy versus 4Gy) to compare how well they work in treating patients with~     follicular or marginal zone non-Hodgkin's lymphoma.~   "
247750|NCT00310154|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib~     together with docetaxel and radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when~     given together with gefitinib and radiation therapy in treating patients with stage III~     non-small cell lung cancer.~   "
247751|NCT00310141|"~     RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and~     computer-assisted counseling may help people stop smoking.~      PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling~     helps African American smokers stop smoking.~   "
247780|NCT00309738|"~     The purpose of this study is to compare the efficacy and safety of pitavastatin with that of~     simvastatin in patients with risk factors for heart disease.~   "
247752|NCT00310128|"~     RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and~     cisplatin, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and yttrium~     Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability~     of cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them without harming normal cells. Giving more than one drug~     (combination chemotherapy) together with rituximab and yttrium Y 90 ibritumomab tiuxetan may~     kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed~     or refractory AIDS-related non-Hodgkin's lymphoma.~   "
247753|NCT00310115|"~     RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after~     pregnancy.~      PURPOSE: This randomized clinical trial is studying three different types of counseling to~     see how well they work in preventing smoking relapse after pregnancy in pregnant women who~     quit smoking during pregnancy.~   "
247754|NCT00310089|"~     RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as~     doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD2171~     together with combination chemotherapy before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed and may kill more tumor cells.~      PURPOSE: This randomized clinical trial is studying how well giving AZD2171 together with~     combination chemotherapy works in treating women with locally advanced breast cancer.~   "
247755|NCT00310076|"~     RATIONALE: Thalidomide may stop the growth of tumor cells by blocking blood flow to the~     tumor. Giving thalidomide after surgery and chemotherapy may kill any remaining tumor cells.~      PURPOSE: This phase II trial is studying how well thalidomide works in treating patients who~     have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic~     perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or~     appendix cancer .~   "
247756|NCT00310063|"~     RATIONALE: Using acupressure wrist bands to press and stimulate nerves at an acupressure~     point on the inside of the wrist may help control nausea and vomiting caused by chemotherapy.~      PURPOSE: This randomized clinical trial is studying how well acupressure works in preventing~     nausea and vomiting in young cancer patients receiving chemotherapy.~   "
247757|NCT00310050|"~     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes~     needed for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high energy x-rays to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when~     given together with radiation therapy in treating patients with locally advanced pancreatic~     cancer.~   "
247758|NCT00310037|"~     This randomized phase II trial studies how well bortezomib works when given after combination~     chemotherapy, rituximab, and an autologous stem cell transplant in treating patients with~     mantle cell lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) together with an autologous stem cell~     transplant may allow more chemotherapy to be given so that more cancer cells are killed.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Giving bortezomib after combination~     chemotherapy, monoclonal antibody therapy, and an autologous stem cell transplant may kill~     any remaining cancer cells or keep the cancer from coming back.~   "
247759|NCT00310024|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with bortezomib in treating patients with relapsed or refractory multiple myeloma.~     Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving vorinostat together with bortezomib may kill more cancer cells~   "
247760|NCT00310011|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel~     and cisplatin works in treating patients with advanced transitional cell cancer of the~     urothelium.~   "
247761|NCT00309998|"~     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor~     cells by blocking blood flow to the tumor. Giving vinorelbine together with bevacizumab may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving vinorelbine together with~     bevacizumab works in treating older patients with stage III or stage IV non-small cell lung~     cancer.~   "
247762|NCT00309985|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy~     may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known whether androgen-ablation~     therapy is more effective with or without docetaxel in treating metastatic prostate cancer.~      PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and~     chemotherapy to see how well they work compared to androgen-ablation therapy alone in~     treating patients with metastatic prostate cancer.~   "
248303|NCT00302731|"~     Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose~     PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather~     early information about safety when natural or bioidentical hormones are used during early~     menopause.~   "
247763|NCT00309972|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and vinorelbine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known~     whether giving combination chemotherapy followed by radiation therapy is more effective than~     giving combination chemotherapy together with radiation therapy followed by more chemotherapy~     in treating non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by~     radiation therapy to see how well it works compared to combination chemotherapy combined with~     radiation therapy followed by more chemotherapy in treating patients with stage III non-small~     cell lung cancer that cannot be removed by surgery.~   "
247764|NCT00309959|"~     This phase II trial is studying how well ABI-007 works in treating patients with persistent~     or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~   "
247765|NCT00309946|"~     This phase II trial is studying how well cediranib maleate works in treating patients with~     malignant mesothelioma that cannot be removed by surgery. Cediranib maleate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking~     blood flow to the tumor~   "
247766|NCT00309933|"~     RATIONALE: Studying quality of life in breast cancer survivors may help determine the~     long-term effects of breast cancer and may help improve the quality of life for future breast~     cancer survivors.~      PURPOSE: This clinical trial is studying quality of life in female breast cancer survivors~     and their spouse, partner, or acquaintance.~   "
247767|NCT00309920|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such~     as darbepoetin alfa, may increase the number of immune cells found in bone marrow or~     peripheral blood and may help the immune system recover from the side effects of~     chemotherapy. Giving combination chemotherapy together with darbepoetin alfa after surgery~     may kill any tumor cells that remain after surgery. It is not yet known whether combination~     chemotherapy and darbepoetin alfa are more effective than combination chemotherapy alone in~     treating stage III breast cancer.~      PURPOSE: This randomized clinical trial is studying how well giving combination chemotherapy~     together with darbepoetin alfa works compared to combination chemotherapy alone in treating~     women with stage III breast cancer.~   "
247768|NCT00309907|"~     This phase II trial is studying how well etanercept works in treating young patients with~     idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may~     be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor~     stem cell transplant.~   "
247769|NCT00309894|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as~     ketoconazole, may stop the adrenal glands from making androgens. GM-CSF may help ketoconazole~     work better by making tumor cells more sensitive to the drug. Giving ketoconazole together~     with hydrocortisone and GM-CSF may be an effective treatment for prostate cancer.~      PURPOSE: This phase II trial is studying how well giving ketoconazole together with~     hydrocortisone and GM-CSF works in treating patients with progressive prostate cancer after~     hormone therapy.~   "
247770|NCT00309881|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Giving more than one drug (combination chemotherapy)~     together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with rituximab works in treating patients with chronic lymphocytic leukemia (CLL) that has~     not responded to fludarabine (closed to entry as of 10/2006), CLL with autoimmune hemolytic~     anemia, or Richter transformation.~   "
247771|NCT00309868|"~     We hypothesize that nesiritide will have favorable effect in decreasing heart filling~     pressures and echocardiogram studies.~   "
247772|NCT00309855|"~     This study is being done to understand how testosterone, the major male sex hormone, controls~     the pituitary gland's secretion of growth hormone (GH). GH is an important metabolic hormone,~     which controls sugar; fat and protein use in the body and maintains muscle strength and bone~     calcium content. Both testosterone and GH decline in older men. The age-related fall in these~     hormones probably contributes to relative frailty, reduced quality of life, bone loss, muscle~     wasting and impaired sexual function.~   "
247773|NCT00309842|"~     RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and~     total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop~     the growth of cancer cells and prepares the patient's bone marrow for the stem cells. When~     the healthy stem cells from a donor are infused into the patient they may help the patient's~     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving cyclosporine and mycophenolate mofetil may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide~     together with total-body irradiation works in treating patients who are undergoing an~     umbilical cord blood transplant for hematologic cancer.~   "
247774|NCT00309816|"~     The purpose of this study is to determine if sildenafil (Viagra) improves exercise tolerance.~   "
247775|NCT00309803|"~     Multicenter, prospective, study designed to demonstrate the performance and safety of the~     Lumen Biomedical, Inc. FiberNet Embolic Protection System as an adjunctive device during~     carotid artery percutaneous intervention. The primary endpoint is the rate of all stoke and~     death within 30 days of the procedure.~   "
247776|NCT00309790|"~     Despite advances in medical therapy for patients with heart failure, one-third of patients~     remain limited by fatigue and shortness of breath.~      Our previous study concluded that one dose of sildenafil (Viagra) lead to an improvement in~     heart pressure and exercise capacity.~      Currently sildenafil is not FDA approved for the treatment of heart failure.~      The purpose of this study is to determine if treatment with sildenafil for 12 weeks in~     patients with heart failure can improve exercise capacity and quality of life in people with~     heart failure.~   "
247781|NCT00309725|"~     The objective of this trial was to investigate the effect of galantamine (an~     acetylcholinesterase inhibitor) on heart rate and PR interval (the time it takes for the~     heart's electrical impulse to get from the atria to the ventricles) during the administration~     of rapidly increasing doses and at the end of a 2-week treatment period with 32 mg per day in~     patients with Alzheimer's disease.~   "
247782|NCT00309712|"~     The primary study hypothesis of this study is to determine whether there is a greater~     percentage of patients achieving a triglyceride level of <200 mg/dL with the combination of~     simvastatin 20 mg and fenofibrate 160mg than with either simvastatin 20 mg monotherapy or~     fenofibrate 160mg monotherapy.~   "
247783|NCT00309699|"~     The purpose of this study is to evaluate the effectiveness and safety of flexible-doses~     paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with~     Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also~     evaluate the effects of paliperidone ER on global functioning, and will compare the~     effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.~   "
247784|NCT00309686|"~     The purpose of this study is to evaluate the effectiveness and safety over a 6-week period of~     paliperidone ER compared with placebo in treating subjects with Bipolar I Disorder who are~     experiencing a manic or mixed episode while they are taking lithium or valproate. This study~     will also evaluate the effect of paliperidone ER compared with placebo on overall~     functioning, on how quickly a response is seen, on improvement in severity of illness, on~     health-related functional status, on depressive symptoms, and on psychotic symptoms. The~     relationship between blood levels and the effectiveness and safety of paliperidone ER will be~     evaluated, including the effect of food relative to time of taking the drug.~   "
247785|NCT00309673|"~     The use of local anaesthesia efficiently reduces pain due to needle puncture. However, when~     tuberculin skin test is performed it is the skin reaction to tuberculin injection that is~     studied. It is a quantitative skin reaction measured in millimiters. From the study of~     literature it is not known whether local anaesthetic modify skin reaction to tuberculin.~     Therefore, before recommending the use local anaesthesia for tuberculin intradermal injection~     we have to rule out a potential effect of local anaesthetic on the result of the test. This~     is particularly important in children, since there are more sensitive to pain than adults~   "
247786|NCT00309660|"~     Treatment with PPARgamma ligands have been shown to reduces intestinal inflammation in murine~     models of colitis. The aim of this study was to evaluate the effect of treatment with local~     PPARgamma ligand (rosiglitazone) in distal ulcerative colitis.The patients are treated with~     rosiglitazone enema, once a day, for fourteen days. Disease activity was assessed before and~     after treatment by endoscopical and clinical activity score.~   "
247787|NCT00309647|"~     Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian~     virus. Prevention and control of a pandemic will depend on the rapid production and worldwide~     distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be~     developed and tested in clinical trials to determine the most optimal formulation and the~     best vaccination schedule.This study is designed to test in healthy adults aged between 18-60~     years the reactogenicity and immunogenicity of one and two administrations of a candidate~     pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen~     doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to~     detect the optimal formulation for immunization against the H5N1 influenza strain.~   "
247788|NCT00309634|"~     Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian~     virus. Prevention and control of a pandemic will depend on the rapid production and worldwide~     distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be~     developed and tested in clinical trials to determine the most optimal formulation and the~     best vaccination schedule.This study is designed to test in healthy adults aged between 18-60~     years the reactogenicity and immunogenicity of one and two administrations of a candidate~     pandemic H5N1 vaccine formulated from Split Virus. The vaccines contain different antigen~     doses . For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to~     detect the optimal formulation for immunization against the H5N1 influenza strain.~   "
247789|NCT00309621|"~     Patients with severe chronic hand dermatitis, that has not responded to topical treatment,~     including topical steroids and the avoidance of aggravating factors, will be treated with the~     oral medication alitretinoin. The study aims to investigate the safety and efficacy of the~     medication when given over a period of 6 months.~   "
247790|NCT00309608|"~     The objective of the study is to test the efficacy, safety and tolerability of several doses~     of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks~     together with metformin in patients with type 2 diabetes mellitus who are not at goal with~     their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as~     add-on therapy to metformin for comparison. The influence of several factors (gender, age,~     weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in~     this study.~   "
247791|NCT00309595|"~     This is a multi-center prospective, randomized, two-arm study evaluating performance of the~     Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be~     randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered~     into the study.~      Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent~     System for the treatment of superficial femoral artery (SFA) long de novo or restenotic~     lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined~     by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one~     year as demonstrated by Duplex sonography.~   "
247807|NCT00309387|"~     The Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related~     Cataract (CTNS) is a 13-year study designed primarily to evaluate the safety and efficacy of~     a vitamin-mineral supplement (Centrum) containing recommended daily-allowance dosage (RDA) in~     preventing age-related cataract or delaying its progression in participants with early or no~     cataract at baseline.~   "
247808|NCT00309374|"~     The purpose of this study is to determine the effects of HMG-CoA reductase inhibitor~     pretreatment on inflammation and coagulation activation in human endotoxemia.~   "
247792|NCT00309582|"~     Nevirapine (NVP)-based antiretroviral therapy (ART) has been commonly used in many developing~     countries due to its affordability and feasibility. Nonetheless, the potential drug-drug~     interaction between NVP and fluconazole (FLU) is a major concern. NVP can induce cytochrome~     P450 isoenzymes in the liver while FLU inhibit the activity of this enzyme. The recent report~     has demonstrated that fluconazole significantly raises plasma NVP levels and may cause~     serious hepatotoxicity. Conversely, NVP does not significantly influence the plasma level of~     FLU. However, there have not been enough data or any recommendations to adjust NVP dosage for~     the concurrent use of both drugs in order to avoid the adverse events. A previous study has~     demonstrated that genetic disposition may play a role in NVP hypersensitivity reactions.~     There is little data of safety and tolerability for concurrent use of NVP and FLU in Asian~     populations. We therefore conducted this prospective observational study to compare the~     trough plasma NVP levels and frequencies of adverse events among antiretroviral HIV-infected~     patients who did not receive FLU and received FLU in different dosages for cryptococcosis~     prophylaxis or treatment; and subsequently received NVP-based ART regimens.~   "
247793|NCT00309569|"~     Primarily, this clinical investigation compared overall survival and recurrence-free survival~     in patients with hormone receptor-negative breast cancer treated with pre- and postoperative~     chemotherapy vs. conventional postoperative treatment.~   "
247794|NCT00309556|"~     Primarily, this clinical investigation compares the rates (percentages) of pathological~     complete remissions attained at the time of final surgery following 6 cycles each of~     epirubicin + docetaxel + capecitabine-containing chemotherapy ± trastuzumab (in HER-2~     positive disease) vs. epirubicin + docetaxel-containing chemotherapy ± trastuzumab (in HER-2~     negative disease).~   "
247795|NCT00309543|"~     This clinical investigation examined the influence of cytostatic chemotherapy with~     5-fluorouracil, modulated by biologically active leucovorin, on patients’ survival time~     following surgery for colon carcinoma Stage II.~   "
247796|NCT00309530|"~     This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or~     interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple~     combination, in terms of recurrence-free and overall survival in curatively operable colon~     carcinoma Stage III.~   "
247797|NCT00309517|"~     This clinical investigation examined the influence of preoperative radiotherapy in~     combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil +~     leucovorin + MAb 17-1A chemo-immunotherapy on patients’ local recurrence rate and overall~     survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).~   "
247798|NCT00309504|"~     The purpose of this study is to find ways to improve the appearance of tumours or markers~     that indicate the presence of tumours in Magnetic Resonance Imaging (MRI). Although based on~     the same technology, there are many ways to obtain images using MRI. The type of image that~     will be produced by the scanner depends on the instructions sent to the machine. These~     instructions tell different components of the machine when to turn on and off and all~     together are called a pulse sequence. These pulse sequences can get quite lengthy and~     intricate and small changes in them can produce considerable changes in the resulting image.~     the aim of this protocol is to alter existing pulse sequences to improve image appearance.~     This protocol will involve only healthy volunteers.~   "
247799|NCT00309491|"~     Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide~     vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with~     potentially curative, operated hormone receptor-positive breast cancer.~   "
247800|NCT00309478|"~     Primarily, this clinical investigation compared the efficacy of cyclophosphamide +~     methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of~     prognosis (disease-free survival, overall survival) in premenopausal patients with~     potentially curative, operated hormone receptor-positive breast cancer.~   "
247801|NCT00309465|"~     The main objective of this study is to compare three strategies of evening insulin glargine~     dosing to preoperative glucose values in patients with diabetes undergoing surgery to~     determine which dosing strategies most often achieves the admission target study values of~     100-179 mg/dl.~   "
247802|NCT00309452|"~     The purpose of this study is to understand the effectiveness of a specialized package of~     phase-specific treatments for individuals in the midst of their first episode of psychosis.~     The pharmacologic and psychosocial treatments will be delivered within a state public mental~     health center.~   "
247803|NCT00309439|"~     The problem is the lack of data from randomized controlled trials to throw light on the~     ALA-prostate cancer issue. There is therefore a need to acquire evidence from a randomized~     controlled study to illustrate the effect of ALA on a surrogate marker for prostate cancer,~     namely prostate specific antigen (PSA). Demonstration that atrial fibrillation recurrence was~     reduced after cardioversion and that there was no adverse effect of 1 years of ALA feeding on~     PSA would go a considerable way to providing the required evidence that ALA in the human diet~     has no adverse effect on the prostate and so allow its use for cardiovascular risk reduction.~     hypothesis: The effect of ALA on PSA levels over time will be no different from the control,~     so providing supportive data for the view that ALA is not cancer promoting.~   "
247804|NCT00309426|"~     The purpose of this study is to examined the effect of fetuin A on atherosclerosis and~     prognosis in hemodialysis patients.~   "
247805|NCT00309413|"~     The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is~     effective in the treatment of acute schizophrenic or schizophreniform psychosis in a~     placebo-controlled, randomized double-blind study.~   "
247806|NCT00309400|"~     We are doing this study to learn more about the early history of universal screening for~     metabolic disorders such as PKU and galactosemia. In particular, we are interested in~     learning from our past experience to inform our current plans to expand universal newborn~     screening. Following standard historical research methodology, we will begin with a review of~     the historical scholarship on PKU and galactosemia, including more general works on mental~     retardation, genetics, public health screening, and metabolic disorders. We will also obtain~     scientific publications and archival sources on the early screening and treatment of these~     disorders. Lastly, we will conduct oral history interviews with key participants in teh early~     screening and treatment of PKU and galactosemia.~   "
247809|NCT00309361|"~     This Phase 3 study is designed as a multicenter, randomized, blinded, controlled study to~     evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a submucosal~     injection following completion of a restorative or periodontal maintenance procedure~     requiring local anesthesia with an agent containing a vasoconstrictor. Local vasodilation~     that results in more rapid clearance of the anesthetic is the proposed mechanism of action.~   "
247810|NCT00309348|"~     This research study aims to show that a newly developed investigational Doppler instrument~     can reliably measure blood flow in dialysis access grafts, to see if a decrease in the flow~     may be a sign of impending graft failure and also to see if there is evidence that by~     monitoring the flow in these grafts their lives may be extended.~      The new investigational device is to be known as FloMon; this is an ultrasonic device that~     provides blood flow measurements from a small probe placed in a noninvasive manner above the~     graft or blood vessel. The instrument is being developed so that it may help give insight to~     on-coming graft failure which may be prevented.~      The FloMon is an extension of a previously Food and Drug Administration (FDA) cleared~     instrument, Echoflow-A, which had been used in a similar study as this one. The Echoflow-A is~     similar to this device in all respects with the exception of design and calculation of~     measurement. The FloMon compared to the Echoflow-A is better ergonomically designed and reads~     flow readings in about 2 minutes versus twice the time necessary to take similar measurements~     using the Echoflow-A.~   "
247811|NCT00309335|"~     This Phase 3 clinical study is designed as a multicenter, randomized, blinded, controlled~     study to evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a~     submucosal injection following completion of a restorative or periodontal maintenance~     procedure requiring local anesthesia with an agent containing a vasoconstrictor. Local~     vasodilatation that results in more rapid clearance of the anesthetic is the proposed~     mechanism of action.~   "
247812|NCT00309322|"~     This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled~     study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11~     years of age. NV-101 or sham injection is administered at the completion of a dental~     procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental~     procedure(s) shall be performed in a single quadrant of the mouth and include cavity~     preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing),~     or crowns.~   "
247813|NCT00309309|"~     Abnormalities in glucidic and lipidic metabolism are common features in renal transplant~     patients on chronic immunossupression with steroids and calcineurin inhibitors. In kidney~     transplant patients with chronic rejection these abnormalities cluster with renal and~     cardiovascular risk factors and altogether may sustain premature graft loss and may increase~     the risk of cardiovascular morbidity and mortality. Thiozolidinediones are a new class of~     oral antidiabetic agents that may increase insulin sensitivity improving the glucose~     tolerance and dyslipidemia. Moreover, rosiglitazone –one of these drugs- has been reported to~     decrease blood pressure and albuminuria in subjects with type 2 diabetes and nephropathy.~     Recent finding that glitazones ameliorate the glucidic and lipidic profile induced by steroid~     treatment in healthy subjects, provided a further rationale to evaluate the metabolic and~     renal effects of glitazones in renal transplant patients on chronic steroid therapy. Thus, we~     designed and organized a pilot study to assess the short-term risk/benefit profile of~     rosiglitazone in renal transplant patients with chronic rejection. Ten patients will have a~     basal evaluation of insulin sensitivity, glucose tolerance,lipid profile, renal hemodynamic~     and albuminuria. These evaluations will be repeated at the end of the treatment (4 months of~     therapy with rosiglitazone 8 mg/day) period and 2 months after treatment withdrawal.~   "
247814|NCT00309296|"~     The purpose of this study is to determine whether an extended care treatment model lasting~     over a year will increase long-term smoking cessation rates compared to the standard 8 week~     treatment of care.~   "
247815|NCT00309283|"~     Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal~     disease, responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western~     countries. At comparable levels of blood pressure control and proteinuria, patients with~     ADPKD have faster decline in glomerular filtration rate than those with other renal diseases~     and do not seem to benefit to the same extent of ACE inhibitor therapy. A reasonable~     explanation for the above findings is that in ADPKD progression is largely dependent on the~     development and growth of cysts and secondary disruption of normal tissue. Thus,~     renoprotective interventions in ADPKD - in addition to achieve maximal reduction of arterial~     blood pressure and proteinuria and to limit the effects of additional potential promoters of~     disease progression such as dyslipidemia, chronic hyperglycemia or smoking - should also be~     specifically aimed to correct the dysregulation of epithelial cell growth, secretion, and~     matrix interactions characteristic of the disease.~      Evidence that specific receptors for somatostatin are present in the kidney tissue, arises~     the possibility that somatostatin treatment in patients with ADPKD might inhibit fluid~     formation and eventually induce the shrinking of renal cysts.To evaluate the tolerability and~     the safety of long-acting somatostatin in ADPKD patients, a prospective cross-over controlled~     study has been recently performed. This pilot study demonstrated the safety of six month~     treatment of long-acting somatostatin in patients with ADPKD. Moreover, the percent increase~     of total kidney volume was significantly lower in patients on somatostatin than in placebo.~     Overall, these findings provide the basis for designing a long-term study in ADPKD patients~     aimed to document the efficacy of the somatostatin treatment in preventing further increase~     or even reducing the total kidney volume and the renal volume taken up by small cysts,~     eventually halting kidney disease progression.~   "
247816|NCT00309270|"~     During the past 15 years, however, the superior immunosuppressive efficacy of CsA and the~     well-known toxicity of long-term steroid therapy have prompted trials of steroid withdrawal~     from renal allograft recipients at various intervals after transplantation. Steroid~     withdrawal or avoidance must be balanced against the associated risk of precipitating acute~     allograft rejection. Moreover, with the current immunosuppressive regimens, by 10 years~     approximately 50% of grafts will have been lost due mainly to chronic rejection or the~     side-effects of immunosuppressive therapy. Thus, the quest for therapies that might induce~     specific immune tolerance – ideally via short-term interventions that would target only the~     pathogenic immune response and leave the protective host immune response unimpaired – has~     provided a “holy grail” for transplant immunologists.~      The humanized IgG monoclonal antibody Campath-1H has been hypothesized to provide enough~     immunosuppression that would allow maintenance therapy with low-dose CsA, and possibly~     reprogramming the immune system so to encourage tolerance processes. Despite Campath-1H~     immunosuppressive regimens have been claimed to induce a condition of “almost tolerance”,~     this has not been proved nor evidence of development of persistent regulatory immune~     responses long-term post transplant has been provided. Thus, characterizing phenotypically~     and functionally distinct subsets of T-regulatory cells possibly generated selectively in~     non-rejecting transplant recipients in Campath-1H-based immunosuppressive regimens may help~     to find new noninvasive markers of immune system activation to tailor immunosuppressive~     protocols.~      The primary aim of the study is to compare the effect of Campath-1H, low dose sirolimus~     versus Campath-1H, low dose CsA, both in addition to low dose MMF on phenotypic and~     functional profiles of peripheral blood mononuclear cells (PBMCs) in kidney transplant~     recipients in a steroid-free regimen.~   "
247834|NCT00309023|"~     This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137~     monoclonal antibody, administered every three weeks to patients with metastatic or locally~     advanced solid tumors.~   "
247817|NCT00309257|"~     Alport syndrome (AS) represents a form of progressive hereditary nephritis in which the~     genetic defect resides in the synthesis of one of several subunits of type IV collagen, the~     predominant constituent of basement membranes in renal glomeruli. Renal impairment occurs~     with time and severe renal failure with hypertension and uremia represent the end stage of~     the disease, even if a high variability in the rate of progression is described.Males are~     usually affected by a progressive form of the disease. Affected females with X-linked~     syndrome usually have a good prognosis with a mild renal impairment. The disease is also~     associated to a sensor neural deafness which can occur in approximately half of the patient~     affected and usually correlates with renal impairment. No definite treatment exists in order~     to delay the time of dialysis or a kidney transplant. Many studies showed that Angiotensin~     converting enzyme (ACE) inhibitors slow glomerular filtration rate (GFR) decline and limit~     progression to end stage renal disease (ERDS) and dialysis in several chronic nephropathies~     associated with proteinuria. The combination of ACE-I with Angiotensin II receptor~     antagonists may reduce proteinuria more effectively than the two drugs alone. Moreover the~     addition of statins may synergize the antiproteinuric effects of ACE-I and ATAII antagonists~     in experimental models of chronic renal diseases.~      The purpose of this study is to evaluate the effect of a standardized multimodal~     nephroprotection intervention (Remission Clinic) in Alport patients with renal involvement.~   "
247818|NCT00309244|"~     The purpose of this 13 month study (12 month treatment period and 1 month follow-up period)~     is to determine whether inhaled insulin is safe and effective in the treatment of type 2~     diabetes.~   "
247819|NCT00309231|"~     The purpose of this study is to perform a series of islet transplants using the Edmonton~     protocol. Patients with Type I Diabetes and glycemic lability, severe hypoglycemia or~     hypoglycemic unawareness will undergo transplantation of purified pancreatic islets from~     cadaveric donors into the portal vein, followed by steroid-free immunosuppression as per the~     Edmonton protocol (IL-2 antibody induction, sirolimus, low dose tacrolimus-based~     immunosuppression). The goals of the transplant are to improve glycemic control, stabilize~     blood sugars and achieve insulin independence.~   "
247820|NCT00309218|"~     The present study investigates the safety and efficacy of steroid withdrawal in pediatric~     renal transplant recipients with stable graft function under concomitant immunosuppression~     with cyclosporine and mycophenolate mofetil.~   "
247821|NCT00309205|"~     Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each~     volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers~     will receive investigational product for a total of 42 days.~   "
247822|NCT00309192|"~     The purpose of this study is to determine whether intravitreal injection of Triamcinolone~     Acetonide is effective in the treatment of Clinically Significant Diffuse Macular Edema due~     to Type 2 Diabetes Mellitus.~   "
247823|NCT00309179|"~     This study proposes to determine the safety of the administration of E7820 plus cetuximab and~     explore the MTD of the combination in a Phase Ib study. In addition, the efficacy of this~     combination will be explored in patients with colorectal cancer in the Phase II proof of~     concept phase of the study.~   "
247824|NCT00309166|"~     The main aim of this vaccine is to prevent cervical cancer in women. However, it could also~     be relevant to vaccinate selected groups of males. Therefore, this study is designed to~     evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male~     subjects aged 10-18 years.~   "
247825|NCT00309140|"~     This study will collect further basic safety data on patients with cancer treated with~     enzastaurin. This study is not open to the public.~      The purpose of the this study is to extend the clinical experience of patients who complete~     enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli~     Lilly and Company and who may benefit from continued enzastaurin therapy.~   "
247826|NCT00309127|"~     Disease management using a multidisciplinary team to achieve and maintain optimal metabolic~     and cardiovascular risk factors control in Type 2 diabetic patients with nephropathy reduces~     the incidence of end stage renal disease (ESRD) and improves clinical outcomes compared to~     usual clinic-based care~   "
247827|NCT00309114|"~     Urinary tract infection (UTI) is the most common infection in patients with spinal cord~     injury (SCI) and is linked to major undesired results or complications including death. The~     bladder of SCI patients, especially those with indwelling catheters, is usually colonized by~     bacteria, some of which do and others which do not cause symptoms of UTI. Bacteria that do~     not cause symptoms are often called benign colonizers and are often left untreated because~     they may provide some protection against infection with more harmful bacteria. This idea of~     using benign bacteria to prevent infections with symptoms is called bacterial interference. A~     prototype strain, Escherichia coli 83972, was shown to begin and continue for extended~     periods of time non symptom causing colonization of the human bladder and to hold back~     symptom causing infections of the neurogenic bladder. Data from pilot studies at two medical~     centers indicated that bacterial interference might be a useful therapy for reducing the rate~     or frequency of UTI in SCI patients. Because almost all SCI patients have a UTI at some time,~     and also the large costs of treating this infection, studying the impact of bladder~     colonization with E. coli 83972 on the rate of symptom causing UTI has an amazing potential~     for improving the quality of life of SCI patients and decreasing the cost of health care.~     Like with other preventive plans such as vaccination, for instance, it is important to~     explore the effectiveness of this new preventive approach. The project is a prospective,~     randomized, double blind, multi-center study that deals with specific pieces of bacterial~     interference in SCI patients.~      HYPOTHESES: Placing non symptom causing bacteria (E. coli 83972) into SCI patients' bladders~     reduces the rate of symptom causing UTI.~      A. SPECIFIC AIM: Determine how bladder colonization with E. coli 83972 or similar bacteria~     affects the rate of symptom causing urinary tract infections in a large group of SCI and~     Spina Bifida patients by conducting a prospective, randomized, placebo-controlled,~     multi-center clinical trial.~   "
247828|NCT00309101|"~     The purpose of the study is to investigate the efficacy and safety for steroid resistant,~     non-thymectomized MG patients.~   "
247829|NCT00309088|"~     The purpose of the study is to investigate the efficacy and safety for steroid non-resistant~     MG patients in a double blind, placebo controlled study.~   "
247830|NCT00309075|"~     The purpose of this study is to look at the safety (what are the side effects) and efficacy~     (how well does it work) of Magnevist (the study drug) used for MRI of the calf and foot~     arteries. The results will be compared to the results of MRI taken without Magnevist, and~     with the results of your X-ray angiography.~   "
247831|NCT00309062|"~     Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic~     rhinoconjunctivitis~   "
247832|NCT00309049|"~     The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.~   "
247833|NCT00309036|"~     The trial is performed to assess efficacy and safety of a recombinant grass Pollen allergen~     cocktail in allergic rhinoconjunctivitis~   "
247835|NCT00309010|"~     This study will examine how the brain coordinates movement in patients with focal hand~     dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and~     repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such~     as the hand, neck or face, is involved. This study will use transcranial magnetic stimulation~     (TMS, see below) to study how the brain plans movement.~      Healthy volunteers and patients with focal hand dystonia 18 years of age and older may be~     eligible for this study. Healthy subjects may participate in one, two or three of the~     experiments described below. Patients with dystonia may participate in experiments one and~     three.~      Before each experiment, each subject is asked about his/her medical and neurologic history,~     complete questionnaires and will undergo a brief physical examination.~      Experiment 1~        -  Surface EMG: Small electrodes are taped to the skin over the arm to measure the~          electrical activity of muscles.~        -  TMS: A wire coil is held on the subject's scalp. A brief electrical current is passed~          through the coil, creating a magnetic pulse that stimulates the brain. During the~          stimulation, the subject may be asked to tense certain muscles slightly or perform other~          simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg,~          and the subject may hear a click and feel a pulling sensation on the skin under the~          coil.~      Experiment 2 (Two visits.)~        -  Visit 1: Magnetic resonance imaging (MRI): This test uses a magnetic field and radio~          waves to obtain images of body tissues and organs. The patient lies on a table that is~          moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and~          thumping sounds that occur during the scanning process. The procedure lasts about 90~          minutes, during which time the patient will be asked to lie still for up to 30 minutes~          at a time.~        -  Visit 2: Surface EMG and TMS~      Experiment 3~      -Surface EMG and TMS - During the TMS, subjects are asked to respond to shapes on a computer~     screen by pushing a button or pressing a foot petal.~   "
247836|NCT00308997|"~     This study will determine the efficacy of MRI-guided transcranial magnetic stimulation~     (TMS)in reducing voices and other symptoms experienced by people with schizophrenia and~     schizoaffective disorder. In addition, the study will determine duration of improvement~     obtained during the course of trial participation via on-going monthly contact with study~     participants for up to 1 year after the trial.~   "
247837|NCT00308984|"~     The purpose of this study is to describe the incidence of recall or awareness under~     anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data~     relating to intra-operative recall during general anesthesia.~      The hypothesis is that the implementation of routine awareness follow-up evaluation in~     children undergoing general anesthesia will identify that the incidence of intra-operative~     awareness in children is equal to or greater than in adults.~   "
247838|NCT00308971|"~     Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in~     both the chronic kidney disease (CKD; pre-dialysis) and end stage renal disease (ESRD; on~     hemodialysis) populations, and several lines of evidence point to their contribution in the~     development of atherosclerosis. Biomarkers of the inflammatory state such as C-reactive~     protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and death in~     these two populations. The uremic state is characterized by retention of oxidized solutes~     including reactive aldehyde groups and oxidized thiol groups. It has recently been~     demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of~     oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the~     atherosclerotic uremic metabolic state. In this study we hypothesize that administration of~     antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress~     in patients with Stage III and IV CKD.~   "
247839|NCT00308958|"~     Patients with cystic fibrosis (CF) must perform daily bronchial drainage therapy (BD) to keep~     their airways clear of secretions. Many different techniques are available to achieve this~     and there is currently no agreement as to which form of therapy is most effective. High~     frequency chest wall oscillation (HFCWO is used for this purpose by CF patients throughout~     the United States and abroad. To perform this therapy, the patient wears a vest which fits~     over the entire torso and is connected to an air compressor. The compressor generates~     oscillating air pulses that are transmitted to the lungs, thereby mobilizing secretions. The~     oscillations produced by the most commonly used device have a sinusoidal wave form (The Vest™~     Airway Clearance System, Hill-Rom Inc, St Paul, MN). Previous studies indicate this form of~     therapy is as effective as more traditional and cumbersome forms of therapy. The design of~     the pulse generator has been recently modified so that the oscillations produced have a~     triangular wave form (Respitech Inc, MN). Studies done at the University of Minnesota found~     that the air flows induced in the airways can vary substantially depending on the wave form~     applied to the chest. At present, the impact of using a triangular wave form on mucus removal~     is unknown. The proposed study will compare mucous clearance using a device generating sine~     wave oscillations to a device generating triangular wave oscillations.~      Hypothesis: Bronchial drainage using a triangular wave form of HFCWO will result in superior~     sputum production compared to HFCWO using a sine wave form.~      Secondary Hypotheses:~      Bronchial drainage using a triangular wave form of HFCWO may result in sputum with rheologic~     properties distinct from sputum produced while using sine wave HFCWO.~      Bronchial drainage using a triangular wave form of HFCWO may result in superior post-therapy~     pulmonary function tests compared to pulmonary function tests obtained following therapy with~     sine wave HFCWO.~      Subjects will perceive bronchial drainage using a triangular wave form of HFCWO as more~     comfortable than airway clearance using sine wave HFCWO.~   "
247840|NCT00308945|"~     Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very~     little information for a major class, the prostaglandin analogues with regard to this aspect.~     The purpose of this study is to compare the effect of travoprost 0.004% and latanoprost~     0.005% on choroidal blood flow and retinal vascular diameter in glaucoma patients. After~     washout of current topical medication, intraocular pressure (IOP) in both eyes (Goldmann~     applanation tonometry), choroidal blood flow (laser Doppler flowmetry) and retinal vessel~     diameter (Retinal Vessel Analyzer) in one randomly selected eye will be measured at baseline,~     after two weeks and after 4 weeks of treatment with travoprost or latanoprost QD, in a~     randomized, double masked 2-way cross-over study in 20 open angle glaucoma patients.~   "
247841|NCT00308932|"~     To determine the effect of age and device on delivery of HFA-Fluticasone Propionate (FP) in~     children of different ages. Hypothesis -- passive inhalation in younger children through a~     valved holding chamber/mask (VHC) will reduce the relative amount of FP delivered to airways.~   "
247842|NCT00308919|"~     To assess by MR Imaging the lesions induced by WST09-mediated photodynamic therapy (PDT) in~     patients with recurrent or persistent localized prostate cancer following definitive~     radiotherapy using different light doses and multiple illuminating fibres.~   "
247843|NCT00308906|"~     The purposes of this study are to identify potential gene and protein markers of~     aminoglycoside-induced kidney injury in infants, children and adolescents treated with~     aminoglycoside antibiotics.~   "
247844|NCT00308893|"~     The main hypothesis is that the therapeutic response and pharmacological resistance to ADs in~     depressed patients can be associated with a polymorphism for the BDNF gene. The research of~     allelic forms associated to lesser efficiency or inefficiency of ADs could add to the body of~     evidence that BDNF mediates the mechanism of action of ADs, and could have important~     practical implications. We propose to compare in a group of patients with major depression,~     the allelic variability of the BDNF gene between responders and non-responders after a 3-week~     period and a 6-week period of SSRI treatment.~   "
247995|NCT00306904|"~     The purpose of this study is to evaluate the pharmacokinetics, safety and preliminary~     efficacy of 3 doses of Cand5. Cand5 is a small interfering RNA molecule that selectively~     silences the mRNA encoding for VEGF. The target population are patients with diabetic macular~     edema.~   "
247845|NCT00308880|"~     Tranexamic acid belongs to fibrinolytic inhibitors. Several prospective randomized clinical~     trials have proved its effectiveness in reducing intra-operative and post-operative bleeding~     in orthopedic and cardiovascular surgeries. However, there is little study about tranexamic~     acid in reducing post-operative bleeding in head and neck surgery. So the aim of this study~     is to investigate if tranexamic acid could reduce post-operative bleeding via prospective~     double-blinded randomized clinic trial.~   "
247846|NCT00308867|"~     The aim of this study is to investigate how the efficacy and tolerability of PD P 506 A-PDT~     relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions~     located on the head. To be able to quantify the effect the patient will be allocated to one~     of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.~   "
247847|NCT00308854|"~     The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild~     to moderate AK lesions located on the head.~   "
247848|NCT00308841|"~     Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing~     patient discomfort during the removal of a lost intrauterine device (IUD).~      Methods: This double-blinded, randomized, placebo-controlled trial included 68 women who~     underwent removal procedure for a lost IUD. Thirty-four women were allocated to the~     lidocaine group and 34 to the saline group. The main outcome measure was the intensity of~     pain during, immediately after, and 20 minutes after the procedure, assessed by a visual~     analog scale. Statistical analysis was performed using Friedman's test with Bonferroni~     correction, Student's t test, and 2.~   "
247849|NCT00308828|"~     The purpose of this study is to determine the prevalence and severity of osteoporosis in~     hemodialysis patients and to evaluate potential correlations with renal bone disease indices~   "
247850|NCT00308815|"~     This is a randomized controlled prospective study which assigned patient to receive manual~     CPR or automatic CPR machine use. The quality and efficacy between manual CPR and machine CPR~     will be evaluated.~   "
247851|NCT00308802|"~     The purpose of this study is to test noninvasive methods to monitor the health and condition~     of new kidneys in people who have received kidney transplants.~   "
247852|NCT00308789|"~     The purpose of this study is to compare two methods of delivering Nasal Continuous Airway~     Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting~     babies off the ventilator and decreasing lung damage.~   "
247853|NCT00308776|"~     This study will determine the effectiveness of administrating a dose of cholecystokinin~     during a binge eating episode in reducing this eating behavior in people with bulimia~     nervosa.~   "
247854|NCT00308763|"~     Nicotine addiction is a serious health problem in the United States; 46 million people smoke~     cigarettes, and 70% of those are trying to quit. The nicotine patch and bupropion, a~     medication used to reduce nicotine cravings, are two commonly used smoking cessation aids.~     Both have been shown to reduce smoking rates, however, the effectiveness of combining the two~     treatments has not been widely examined. This study will evaluate the effectiveness of the~     nicotine patch combined with bupropion at reducing smoking rates among younger, low-income,~     and minority individuals.~   "
247855|NCT00308750|"~     The purposes of this study are to determine:~      The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or~     docetaxel with carboplatin and any side effects that might be associated with the combination~     of these drugs.~      Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and~     carboplatin can help patients with non-small cell lung cancer live longer, compared with the~     combination of docetaxel and carboplatin.~      Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and~     carboplatin can make your tumor smaller or disappear, and for how long, compared with the~     combination of docetaxel and carboplatin.~      The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or~     docetaxel with carboplatin have on your disease related symptoms.~      The relation of smoking history and hormone replacement therapy (for women only) may have to~     your lung cancer treatment results.~      The effects of certain genes and proteins in samples of your blood and tumor tissue in order~     to learn more about non-small cell lung cancer and how enzastaurin works in the body.~   "
247856|NCT00308737|"~     Pulmonary Safety in Diabetics with T/I~   "
247857|NCT00308724|"~     The purpose of this study is to determine whether cognitive behavior therapy (CBT) is~     effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older~     in a primary care setting.~   "
247858|NCT00308711|"~     The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and~     100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R)~     in women who need to have cervical ripneing and induction of labor.~   "
247859|NCT00308698|"~     High recombinant human erythropoietin requirement and elevated serum adiponectin were~     significant determinants of long-term mortality in patients who started hemodialysis therapy.~   "
247860|NCT00308685|"~     This study is designed to evaluate the repeat-dose safety and effectiveness of a~     bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11~     years with asthma. The dosing period lasts three weeks and starts following a three-week~     run-in period.~   "
247861|NCT00308672|"~     The secondary objective is to evaluate the agreement between these criteria and the~     prevalence of concordant and discordant according to different criteria.~   "
247862|NCT00308659|"~     Main hypothesis: microbiological diagnossis off severe community acquired pneumonia can be~     performed by non invasive or semi invasive microbiological tools, semi invasive tools~     including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB).~     A microbiological diagnosis could improve antibiotic therapy efficacy and improve patient's~     outcome.~      These Two strategies have never been prospectivally evauated.~        -  Aim of the study: To evaluate 2 diagnostic strategies: non invasive or semi invasive~          including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy~          (FOB)for the care of patients admitted in intensive care for severe community acquired~          pneumonia and receiving an empirical antibiotic therapy as recommanded by 2001 American~          thoracic guidelines~        -  Type of study randomized multicentric controlled open study~   "
247863|NCT00308646|"~     It will be more effective if we can work on the primary prevention for the high risk groups~     of diabetes and prediabetes such as the early detection.~   "
247864|NCT00308633|"~     This study will measure blood levels of endothelial progenitor cells (EPCs) and nitric oxide~     (NO) in patients with coronary artery disease (CAD) who are participating in a 3-month~     cardiac rehabilitation program at Suburban Hospital in Bethesda, MD. EPCs are a kind of stem~     cell produced by the bone marrow that can develop into cells found in arteries and in the~     heart and, therefore, can repair diseased vessels. The study will examine whether the EPCs~     are affected by exercise and will look at how they may contribute to repair of cells lining~     the diseased arteries as a result of participation in the rehabilitation program.~      People with coronary artery disease may be eligible for this study. Candidates are screened~     with a medical history, physical examination, electrocardiogram, and blood tests. CAD~     patients also to a treadmill exercise test.~      Volunteers' participation ends at the screening visit. The blood drawn at screening is used~     to identify EPC specific genes to compare with the EPC genes from patients with CAD.~      CAD patients participate in Suburban Hospital's cardiac rehabilitation program. The exercise~     portion of the program includes 36 sessions of about 60 minutes each, spaced over~     approximately 3 months. Patients have a baseline blood test at screening and repeat blood~     tests at the end of each month of participation in the rehabilitation program. Some of the~     blood will be used for genetic tests to see how genes of the EPCs are changed by the~     patient's participation in the rehabilitation program.~   "
247865|NCT00308620|"~     Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV~     effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for~     malaria treatment and prevention, and it also has significant anti-inflammatory effects. No~     formal study of chloroquine has been performed in people with HIV infection. Chloroquine is~     used worldwide and is quite inexpensive outside of the United States. If shown to be~     effective, chloroquine could be a very important tool worldwide in delaying HIV disease~     progression which would extend the time period without needing anti-retroviral therapy. In~     countries where anti-retroviral therapy is not available, this could be very helpful.~      This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a~     once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws~     for CD4 counts, HIV viral loads, and other research tests. The visits are at study~     enrollment, 4 weeks, and 8 weeks.~   "
247866|NCT00308607|"~     The purpose of this study is to determine whether combination therapy with bevacizumab~     (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) is effective in patients with~     locally advancing or metastatic melanoma.~   "
247867|NCT00308594|"~     The purpose of this study is to determine whether dexamethasone is effective in the treatment~     of pain and disability resulting from a compressed spinal nerve in the neck (cervical~     radiculopathy).~   "
247868|NCT00308581|"~     To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over~     26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with~     infliximab~   "
247869|NCT00308568|"~     The purpose of this study is to evaluate the effect of a mailed educational brochure on~     adherence to referral for screening colonoscopy. The comparison (or control) group receives~     no mailer, which is usual care.~   "
247870|NCT00308555|"~     We are conducting a study to assess whether smoking marijuana affects the safety of~     prescribed opioids in patients treated for chronic pain. This study will assess whether~     smoking cannabis affects the absorption, distribution, metabolism and excretion of widely~     used opioid analgesics. We propose to do this by investigating the effects of smoked cannabis~     in subjects prescribed morphine or oxycodone for chronic pain. We will also assess the~     clinical safety of cannabinoids and these opioids by monitoring the short-term side effects~     associated with combined therapy.~   "
247871|NCT00308542|"~     This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for~     the treatment of diabetic edema.~   "
247872|NCT00308529|"~     This proposed phase II trial will investigate the combination of irinotecan, carboplatin and~     bevacizumab along with radiation in the treatment of patients with limited-stage SCLC. This~     study differs from our maintenance bevacizumab trial in that bevacizumab will begin with~     the initial chemotherapy treatment. Irinotecan/platinum regimens are emerging as standard~     treatments for patients with extensive-stage disease. Adding a novel minimally toxic agent to~     this regimen up front may further enhance this doublet's efficacy without contributing to~     toxicity. This trial will be one of the first clinical trials to evaluate a combination of~     targeted therapy and chemotherapy in the up front treatment of a common solid tumor.~   "
247873|NCT00308516|"~     This phase II trial will investigate the combination of adjuvant 5-fluorouracil, radiation,~     and bevacizumab in patients with stage II and III rectal cancer, followed by FOLFOX6 and~     bevacizumab. Fluorouracil (FU) has proven to be an effective and safe regimen in the~     treatment of stage II and III rectal cancer. Recent evidence has proven~     fluorouracil/leucovorin (FL) in combination with bevacizumab is superior to FL alone and when~     combined with irinotecan is superior to (irinotecan plus fluorouracil/leucovorin (IFL) alone.~     This trial will be one of the first clinical trials to evaluate a combination of targeted~     therapy, radiation, and chemotherapy in the adjuvant treatment of a common solid tumor.~   "
247874|NCT00308503|"~     The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance~     of patients with primary insomnia using night polysomnography recordings over a 6-week~     treatment period corresponding to a stabilization of improvement of sleep.~   "
247875|NCT00308490|"~     The purpose of this study is to describe alterations of serum ferritin, transferrin~     saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes,~     reticulocyte hemoglobin content after iron loading in hemodialysis patients.~   "
247876|NCT00308477|"~     This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone~     for the treatment of macular edema associated with branch retinal vein occlusion.~   "
247877|NCT00308464|"~     The purpose of this study is to explore the safety, toleration and dose response of~     PHA-794428 after multiple weekly injections in male and female growth hormone deficient~     patients.~   "
247996|NCT00306891|"~     The purpose of this study is to determine whether food has any effect on a single dose of~     Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of~     fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.~   "
247878|NCT00308451|"~     The purpose of the proposed work is to assess the effects of a dietary supplement, containing~     chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on~     glycemic control in type 2 diabetes. Specifically, this study will assess whether use of the~     supplement will lower the post-prandial rise in blood glucose experienced after ingestion of~     a 75g carbohydrate load, relative to placebo, in type 2 diabetic patients. The study will~     also assess the chronic effects of supplementation over a 4-week period (relative to placebo)~     on fasting plasma levels of glucose, insulin, lipids and lipoproteins.~   "
247879|NCT00308438|"~     The purpose of the study is to determine whether an investigational compound, ALX-0600, is~     safe and effective in treating Crohn's Disease.~   "
247880|NCT00308425|"~     The primary aim of this study is to evaluate the safety and efficacy of EC-MPS plus valsartan~     as part of an intensified multifactorial intervention on the reduction of the 12-month rate~     of transplant nephropathy compared with EC-MPS plus standard practice of care in recipients~     of a first cadaver donor kidney transplant given CsA-ME, basiliximab, and short-term~     steroids.~   "
247881|NCT00308412|"~     Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children~     under 5 years of age, causing serious respiratory tract disease. The purpose of this study is~     to test the safety of and immune response to a new HPIV vaccine in healthy infants and~     children.~   "
247882|NCT00308399|"~     A 7 day study which involves 2 nutrient drink tests, an ECG, a Scintigraphy scan, and a Sect~     scan. This study requires the participant to make 4 visits to the GCRC in the Charlton~     building but no overnight stays.~   "
247883|NCT00308386|"~     Although strong clinical evidence exists that patients with diabetes should achieve certain~     clinical goals (i.e. HbA1C, BP, LDL, etc.), to reduce morbidity and mortality national~     surveys indicate that only a minority of people with diabetes achieves these goals.~      Hypothesis: combination of nurse case management and enhanced behavior change counseling will~     improve outcomes for glycemic control, blood pressure and cholesterol in high risk patients~     with Type 2 diabetes when compared to usual care over a 3 year period.~      Study design- The study will be a three year randomized control trial that will select~     patients that have either A1C >8.5, LDL >130, or BP >140/90. Nurse case managers, trained in~     clinical guidelines and brief behavior change counseling techniques (motivational~     interviewing), will aim to foster patient adherence in the experimental group patients. Nurse~     case managers will use standing orders to set an implementation of clinical guidelines (for~     diabetes, hypertension, hyperlipidemia and depression) with individual follow up.~      A total of 820 patients between the all 9 (6 Hershey Medical Center and 3 Reading Hospital~     affiliated clinics) will be sought. One third of the study patients will be recruited from~     the underserved Hispanic population in the Reading area. Patients will be randomized by~     physician i.e. one physician will be randomly assigned to have all their patients co-managed~     by a nurse case manager; the other will have usual care without any contact with nurse case~     manager.~      Nurses will be trained and then initiate a small pilot study in July thru August. Full~     recruitment and initiation of study will begin in September 2006.~      Clinic Activities - Each nurse will be responsible for 3 clinics. Nurses will work under the~     supervision of the primary care physicians. A set of clinical guidelines will be developed~     with physician input that will serve as the over-riding framework for the nurses.~      Outcomes - Over a three-year period the investigators will evaluate clinical response~     (improvements in A1C, BP, LDL, and depression when present) as well as a series of other~     measures that will be obtained by surveys (patient satisfaction, quality of life,~     self-management behaviors). Provider satisfaction will be measured using a standardized tool.~     Finally, cost effectiveness of the intervention and evaluation of the potential barriers to~     implementation will be studied.~   "
247884|NCT00308373|"~     People with type 2 diabetes mellitus (earlier known as maturity onset diabetes mellitus) have~     high blood levels of sugar and fat. This study is being done to determine if excessive sugar~     entering the blood in people with type 2 diabetes mellitus is caused by excessive fat. We~     will also evaluate how the anti-diabetic medications, pioglitazone and metformin taken by~     mouth work to control blood sugar in people with diabetes.~   "
247885|NCT00308360|"~     This is an eight-week open-label randomized parallel group clinical trial focusing on the~     comparison of risperidone alone with risperidone plus valproate among hospitalized adult~     patients diagnosed with schizophrenia who also exhibit problems with hostility. Patients may~     have already been receiving risperidone or valproate (but not both) at study entry. Patients~     not receiving valproate at study entry were randomized to receive either risperidone alone or~     risperidone with valproate. For patients already receiving valproate at study entry, their~     antipsychotic medication(s) was switched to risperidone, and they were followed for a~     four-week lead-in period prior to baseline assessment and randomization to receive~     risperidone alone or continue with risperidone and valproate. We hypothesized that~     risperidone alone has an antiaggressive/antihostility effect, and that this effect is~     augmented by the co-administration of valproate.~   "
247886|NCT00308347|"~     Evaluate the effect of Losartan in reducing kidney disease in patients with Non-insulin~     Dependent Diabetes and Nephropathy (kidney damage that usually accompanies late stage~     Diabetes Mellitus).~   "
247887|NCT00308334|"~     The purpose of this study is to evaluate the effect of domperidone (given to lactating~     mothers of very preterm infants) on the macronutrient composition of human milk.~   "
247888|NCT00308321|"~     Parallel group double blind randomised in patients with first episode corticosteroid~     sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a~     longer tapering steroid regimen with standard regime~   "
247889|NCT00308308|"~     To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes~   "
247890|NCT00308295|"~     The main goal of this study is to determine whether the American Heart~     Association-recommended fish oil dose is efficacious, safe, and tolerable in hemodialysis~     patients. The secondary objective is to test the effects of fish oil supplementation on~     inflammatory and cardiovascular markers.~   "
247891|NCT00308282|"~     This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of~     treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for~     patients with Rheumatoid Arthritis. Patients will receive three intravenous doses of~     LY2127399 or placebo. Patients will participate in 10 or more visits to the study site, over~     6 months. Evaluation of safety and efficacy will be conducted throughout the study.~   "
247892|NCT00308269|"~     This is a Phase I clinical trial evaluating the safety and tolerability of escalating doses~     of vintafolide (EC145) in participants with relapsed or refractory advanced tumors. The~     primary objective of this study is to determine the safety and maximum tolerated dose of~     vintafolide given by intravenous bolus or infusion. The efficacy of the treatment will also~     be measured.~   "
247997|NCT00306878|"~     The purpose of this clinical research study is to determine the safety, pharmacokinetics,~     immunogenicity in humans, the recovery time required from the biologic effects and the~     optimal biologic dose range of BMS188667 (CTLA4Ig)~   "
247893|NCT00308256|"~     The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has~     shown that in France, only 15% of children and 26% of adults had HbA1c<7%. Adolescents seem~     to need particularly a better metabolic control.~      Working Hypothesis:~      We hypothesized that a stricter control of glycaemia by nurse-counselling could probably~     improve metabolic control in adolescents with type 1 diabetes.~      Objectives:~      To show that nurse-counselling may improve levels of patient satisfaction.~      Methodology:~      The main criterion is the patient acceptance of diabetes measured by an analogical visual~     scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to~     10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to~     improve patient's appreciation by 10 mm, near to I cope very well with my diabetes.~      This is a randomised parallel group study with 36 subjects in each group. During the~     follow-up, the routine follow-up group will continue its routine care. The complementary~     follow-up group will be called by nurses every 15 days and consult monthly. HbA1c is the~     secondary criterion and will be measured every 3 months.~      The total study duration is 18 months including 6 months for the recruitment and 12 months~     for the patients follow-up~   "
247894|NCT00308243|"~     It is hypothesized that the inhalation of sodium pyruvate will reduce lung damage in patients~     with Cystic Fibrosis (CF) by its ability to reduce levels of toxic reactive oxygen and~     nitrogen compounds associated with the chronic inflammatory component of the disease. The~     primary objective of the study is to assess the safety of inhaled sodium pyruvate in 0.9%~     sodium chloride (saline) solution in people with CF. Further, to determine whether inhaled~     sodium pyruvate will improve lung function, as determined by spirometry, or reduced~     inflammatory markers in induced sputum of people with CF.~   "
247895|NCT00308230|"~     The object of this study is to measure the levels of B-type Natriuretic Peptide (BNP) in~     patients with congenital heart disease, normal individuals, and patients with acquired heart~     failure, and compare the results from each group.~   "
247896|NCT00308217|"~     The objective of this research proposal is to perform an ongoing single institution~     prospective clinical trial examining the overall clinical outcome of children with single~     ventricle physiology.~   "
247897|NCT00308204|"~     The purpose of this study is to investigate the efficacy of Raptiva (efalizumab) in the~     treatment of discoid lupus erythematosus (DLE). Discoid lupus erythematosus is a chronic~     disorder, which may lead to permanent and progressive loss of hair. Lupus is a condition of~     chronic inflammation cause by an autoimmune disease. Autoimmune diseases are illnesses which~     occur when the body's tissues are attacked by its own immune system. The immune system is a~     complex system within the body that is designed to fight infectious agents, for example,~     bacteria, and other foreign invaders.~      One of the mechanisms that the immune system uses to fight infections is the production of~     antibodies. Patients with lupus produce abnormal antibodies in their blood that target~     tissues within their own body rather than foreign infectious agents. Lupus can cause disease~     of the skin, heart, lungs, kidneys, joints, and nervous system. When only the skin is~     involved, the condition is called discoid lupus erythematosus (DLE).~      Raptiva (efalizumab) is a humanized immunoglobulin(a protein extract from blood which fights~     off infection-sometimes called antibody), which targets the immune cells that are activated~     in inflammation. Raptiva has been approved for use in the management of psoriasis at doses of~     1mg/kg, but is not approved for the treatment of DLE.~   "
247898|NCT00308191|"~     The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment~     of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide~     alone.~   "
247899|NCT00308178|"~     The purpose of this trial is to see if Abraxane, which is a new form of paclitaxel, is safe~     as a replacement form of paclitaxel in dose-dense chemotherapy. This trial will also~     determine if using Abraxane will allow patients to receive treatment every two weeks without~     requiring injects of G-CSF, a white blood cell stimulating growth factor.~   "
247900|NCT00308165|"~     This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it~     is given directly into brain tumors by a delivery technique called convection-enhanced~     delivery. This drug has been used for different types of cancer, but in this study it will be~     given by an experimental delivery technique designed to maximize the amount of drug delivered~     to the brain tumor and minimize the side effects in other parts of the body.~      This study will also evaluate advanced magnetic resonance (MR) imaging techniques.~      The study will assess quality of life parameters throughout the follow-up period.~   "
247901|NCT00308152|"~     Colonoscopy and sedation are frequently accompanied by hypotension, which reduces the amount~     of sedation able to be employed. Blood pressure is restored by the infusion of intravenous~     normal saline. Prophylactic infusion of normal saline may enhance the colonoscopy completion~     rate, and patient comfort during colonoscopy and during the recovery from colonoscopy.~      The investigators propose randomising consenting adult patients attending outpatient~     colonoscopy to one of two treatment arms:~      (i) A control arm~      (ii) A treatment arm, with pre-hydration with an infusion of 1.0 litre of normal saline~     immediately prior to colonoscopy.~      Outcome measures include colonoscopy completion rates, hypotension during or after~     colonoscopy, and patient ratings of comfort and satisfaction.~   "
247902|NCT00308139|"~     A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of~     Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with~     Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic~     Medications.~   "
247903|NCT00308126|"~     Purpose: To compare the incidence of post-surgery complications and evaluate relevant~     parameters within 28 days after an operation in HES (130/0.4) and albumin treated groups~      Study Design: Open-label, active controlled, parallel group, randomized, multi-center study.~     Per protocol, 624 patients required in 6 study centers.~      Hypothesis: No difference in rate of postoperative (post-op) complications between HES and~     albumin groups~   "
248052|NCT00306163|"~     The aim of this study is to compare the responsiveness of lower airways in adult patients~     with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment~     medication will be administered as follows: ciclesonide will be inhaled once daily at one~     dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study~     duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study~     will provide further data on safety and tolerability of ciclesonide.~   "
247904|NCT00308113|"~     This study will help determine if CoQ10 and prednisone, alone and as a combination decrease~     the decline in cardiopulmonary and skeletal muscle function that occurs in the wheelchair~     confined phase of DMD. Participants who are enrolled in this study should not have taken any~     corticosteroids within the last six months. This is a 13-month, prospective, randomized study~     comparing a daily prednisone arm (0.75mg/kg/day), a CoQ10 arm (serum of greater than 2.5~     ug/mL) and a combination arm (prednisone and CoQ10) with an enhanced standard of care arm in~     wheelchair confined males age 10 to 18 years with an established DMD diagnosis.~   "
247905|NCT00308100|"~     There are no standardized plasma volume replacement protocols during liver transplantation~     surgery. The current study is designed to compare efficacy, safety, and costs of~     perioperative volume replacement with Voluven (Hydroxyethyl starch 130/0.4) and albumin in~     patients undergoing liver transplantation.~   "
247906|NCT00308087|"~     The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim~     will be more effective than rituximab alone.~   "
247907|NCT00308074|"~     The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole~     monotherapy in the treatment of children and adolescents suffering from Autism Spectrum~     Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in~     reducing ASD-associated symptoms of anxiety and aggression, resulting in significant~     improvements in global outcome.~   "
247908|NCT00308061|"~     This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and~     measured the ability of the vaccine to stimulate antibodies directed against the malaria~     protein that the vaccine is based on. Forty adults were randomly assigned to get either the~     experimental malaria vaccine or a rabies vaccine, for comparison.~   "
247909|NCT00308048|"~     Patients with HCV genotype 2 or 3 infection who have a rapid virological response to~     treatment are randomised to either 14 or 24 weeks HCV treatment. Our hypothesis is that there~     is no important difference in effect between the two treatment effect.~   "
247910|NCT00308035|"~     People who have had a stroke often have difficulty walking and problems with their balance.~     The purpose of this project is to examine problems with foot postures in people who have~     weakness on one side of their body~   "
247911|NCT00308022|"~     This study is designed to exam the effects of early management with high frequency percussive~     ventilation (HFPV) on patients with lung injury. Patients at risk for Acute Respiratory~     Distress Syndrome (ARDS) will be enrolled and randomized to one of two groups. One group will~     be managed with HFPV. The second group will be managed with conventional ventilation~     utilizing lung protective techniques. The primary endpoint of the study is rate of ventilator~     associated pneumonia. We hypothesized that use of HFPV in patients at risk for the~     development of ARDS will decrease the rate of ventilator associated pneumonia when compared~     to patients managed with conventional ventilation.~   "
247912|NCT00308009|"~     It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in~     women) at the time of prolapse surgery or at a later date. Women with both conditions were~     randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or~     no leakage when couching was the main end-point, evaluated 1 year after the last surgery~   "
247913|NCT00307996|"~     The purpose of this study is to examine whether CoQ10 administration is effective as an~     antioxidant in hemodialysis patients.~   "
247914|NCT00307983|"~     The purpose of this study is to examined the effect of malnutrition and/or inflammation on~     atherosclerosis and prognosis in hemodialysis.~   "
247915|NCT00307970|"~     To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a~     conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in~     1-6 year old children.~      Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid~     delivered to young children who passively inhale and cannot breath hold.~   "
247916|NCT00307957|"~     The Pillar palatal implant procedure is a minimally invasive and commercially available~     treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe.~     The implants are placed into the soft area in the roof of the mouth providing support to the~     soft palate. This research is being done to compare daytime sleepiness and sleep related~     quality of life after palatal implants.~   "
247917|NCT00307944|"~     The purpose of this study is to determine if using Pantoprazole decreases your daytime~     sleepiness and improves your reaction time when compared to using a placebo (sugar pill).~   "
247918|NCT00307931|"~     An open-label multi-center single-cohort study to assess the safety and efficacy of~     certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek~     patients who have previously responded to infliximab but who no longer have a sustained~     response or became intolerant to infliximab~   "
247919|NCT00307918|"~     Glaucoma is the leading cause of irreversible blindness in the world, resulting from~     progressive axonal destruction of the optic nerve. Primary open-angle glaucoma is the most~     common form, and it is usually painless with insidious onset. Conventional treatment is~     focused on lowering intraocular pressure (IOP), the one risk factor that can be modified,~     which has been demonstrated to protect against further damage to the optic-nerve head.~     Acupuncture is an ancient treatment which has been found to be beneficial for many ailments,~     and may reduce IOP. We propose a pilot study to evaluate whether acupuncture is an effective~     and safe modality for reducing elevated IOP in patients with open angle glaucoma and primary~     ocular hypertension. Patients with elevated IOP on tonometric measurement (20mmHg < IOP <~     30mmHg) will be treated twice-weekly with a standardized (as opposed to individualized)~     acupuncture treatment. Treatment will last for four-weeks (for a total of 8 treatments), and~     patients will be evaluated for IOP diurnal curves at 2 weeks (4 treatment), 4 weeks (end of~     treatment ) and then 4 weeks following the last treatment.~   "
248053|NCT00306150|"~     The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during~     your surgery, is safe and can help reduce the need for a blood transfusion during bladder~     surgery.~   "
248054|NCT00306137|"~     Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients~     Undergoing Surgical Procedures for Lung or Esophageal Cancer.~   "
248358|NCT00302016|"~     This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia~     who are resistant or intolerant to imatinib and to provide patients access to this new drug~     until the drug becomes commercially available.~   "
247920|NCT00307905|"~     We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean~     cumulative morphine consumption in patients scheduled for surgical correction of fracture of~     neck of hip.~      224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the~     trial. Patients will be randomized to receive either intraoperative injection and post~     operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable~     oral placebo tablets. Baseline measurements of relevant outcome measures will taken~     preoperatively. Immediately after surgery, patients will receive an initial dose of morphine~     of 0.1mg/kg body weight. Patients will take the oral study medication for 21 days. Every four~     hours after surgery, patients will be asked to grade their pain on an NRS. Subsequent doses~     of morphine will be calculated based upon the patient's weight and current NRS, according to~     a preplanned scheme. Patients will be permitted to request additional morphine, beyond their~     calculated dose.~   "
247921|NCT00307892|"~     The perception of pain is a complex process that is not yet fully understood. With outpatient~     knee arthroscopy becoming standard of care, postoperative pain management has become~     increasingly important in caring for patients. Traumeel S is a homeopathic complex widely~     used in German-speaking Europe for orthopedic pain and inflammation. It contains a mixture of~     medicinal plants and minerals, all highly diluted. In some recent studies, Traumeel has shown~     anti-inflammatory and analgesic activity.~      In this study, the efficacy of Traumeel S will be compared with placebo in reducing pain~     during the first 48 hours after arthroscopy. Also compared will be 6 day pain levels,~     analgesic consumption, quality of life, post operative knee function, quadriceps atrophy and~     safety.~      The study design is double blind RCT. 98 patients, aged 18-40 and undergoing arthroscopic~     meniscectomy or chondroplasty will be enrolled in the trial. Patients will be randomized to~     receive either intraoperative join irrigation with Traumeel S and oral treatment with~     Traumeel S, or placebo irrigation and oral ingestion. Patients will continue to take active~     or placebo medication for 6 days. Pain will be recorded daily by the patient in the patient~     diary using an 11-point numerical rating score (NRS-11. Patients will also record daily~     consumption of primary and rescue analgesics. Range of motion (RoM) will be measured on~     days 6 and 30 post-operatively, and the Lysholm knee scale and circumference of thigh above~     patella will be measured at 30 days. All these measures will be compared with baseline.~     Patients will be contacted daily by the research assistant to encourage compliance and to~     record their daily NRS and analgesic consumption in the CRF.~   "
247922|NCT00307879|"~     This trial was performed to evaluate the safety and the efficacy of G-CSF based stem cell~     therapy in patients with AMI. MAGIC Cell-1 trial enrolled patients with acute and old~     myocardial infarction, and had two groups of cell infusion, and G-CSF alone. MAGIC Cell-2~     trial enrolled patients with acute myocardial infarction presented within 12 hours after~     onset of chest pain who underwent successful primary PCI. We randomized patients into the~     G-CSF group and the control group.~   "
247923|NCT00307866|"~     Patients with suspicion of primary or secondary hepatic malignancy in whom a radiological~     examination is needed in order to decide on the most appropriate treatment.~   "
247924|NCT00307853|"~     We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean~     cumulative morphine consumption following Total Knee or Hip Arthroplasty.~      224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the~     trial. Patients will be randomized to receive either intraoperative injection and post~     operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable~     oral placebo tablets. Baseline measurements of relevant outcome measures will taken~     preoperatively.~      In the recovery room, the patient will begin to receive IV Dipyrone (Optalgin) 1000mg, for a~     total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). Once back~     in the ward, the patient will be connected to an IV Patient-Controlled Analgesia (PCA)~     device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes,~     should the patient require it. The PCA memory registers the time and dose, and the data will~     be used later to evaluate post-operative pain.~   "
247925|NCT00307840|"~     The purpose of this study was to compare two different initial dosing schemes for the~     administration of paricalcitol in hemodialysis patients with secondary hyperparathyroidism:~     the already in use iPTH/80 scheme, and an iPTH/120 scheme, which corresponds to the~     immediately lower dose, based on current instructions on paricalcitol dose adjustment. We~     studied the effectiveness of the two dosing schemes in achieving a target iPTH level (150 –~     300 pg/mL)~   "
247926|NCT00307827|"~     The purpose of this study is to assess the efficacy, immunogenicity, and safety of various~     doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis~     (IVSR-UC) and to evaluate optimal dosing.~   "
247927|NCT00307814|"~     The purpose of this study is to evaluate the effectiveness and safety of less frequent dosing~     of PROCRIT (Epoetin alfa) in patients with anemia due to Chronic Kidney Disease (CKD) as~     assessed by hemoglobin maintenance, adverse events and health-related quality of life.~   "
247928|NCT00307801|"~     The purpose of this study is to determine whether the study drug is safe and effective in the~     treatment of dysfunctional uterine bleeding.~   "
247929|NCT00307788|"~     It is our hypothesis that patient's expectations concerning treatment outcome will be~     influenced by their psychiatric symptoms, and that this expectancy will have a strong~     influence on the efficacy of acupuncture treatment to suppress experimentally induced pain.~     We will conduct a study, monitoring expectations but not manipulating them, in a cohort of~     patients with chronic low back pain.~   "
247930|NCT00307775|"~     This study will address the following questions:~        -  Does the use of oestrogen inserted vaginally with an applicator, help with the symptoms~          of faecal (bowel) incontinence in women who are past the age of menopause?~        -  Do women find it easy to use?~        -  Is the treatment safe for the womb lining?~        -  Is there any systemic absorption of the treatment?~   "
248055|NCT00306124|"~     This study aims to determine whether levodopa is effective in boosting learning and memory in~     healthy subjects and patients with dementia or Mild Cognitive Impairment.~      We also examine in healthy subjects using functional magnetic resonance imaging which brain~     regions mediate improved learning after levodopa administration.~   "
248056|NCT00306111|"~     The purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to~     mobilize peripheral blood stem cells in patients with Non Hodgkin-lymphoma in an~     intraindividual study~   "
247931|NCT00307762|"~     This is a trial aiming to evaluate the difference of effectiveness between two therapy~     methods in patients with acute stroke. The other aim is to use Navigated Brain Stimulation~     (NBS)to analyze changes in brain networks during the recovery and as the consequence of~     rehabilitation. The groups are:~        -  body-weight supported gate trainer rehabilitation~        -  gait-oriented traditional physiotherapy Patients in physiotherapy group will have 75 min~          physiotherapy daily every workday. This includes 20 minutes walking exercises in the~          traditional group while 20 minutes of gait trainer therapy in the gait trainer group.~          The evaluation of effectiveness of therapy in each group is made after three weeks'~          therapy and at six months. The goal is to have 40 patients until the end of June 2006.~   "
247932|NCT00307749|"~     The primary objectives of the study are to evaluate the efficacy and safety of three doses of~     MCC-257 in patients with mild to moderate diabetic polyneuropathy~   "
247933|NCT00307736|"~     The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and~     erlotinib when administered in combination with external beam radiation therapy(Phase I~     portion) as well as to begin to collect information about whether this combination treatment~     is effective in treating(Phase II portion) patients with locally advanced rectal cancer.~   "
247934|NCT00307723|"~     The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and~     gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as~     to begin to collect information about whether this combination treatment is effective in~     treating patients with locally advanced pancreatic cancer (Phase II portion).~   "
247935|NCT00307710|"~     Primary Objective:~      To assess the trend in immunogenic response across patients administered either licensed~     trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of~     trivalent recombinant baculovirus expressed hemagglutinin vaccines. Immunogenic response is~     defined as a 4-fold or greater increase in serum antibody.~      Secondary Objective:~      To determine the safety and tolerability of 3 doses (15 μg HA per virus, 45 μg HA per virus,~     and 135 μg HA per virus) of recombinant baculovirus-expressed HA vaccine in patients with~     non-Hodgkin's B-cell lymphoma.~   "
247936|NCT00307697|"~     Currently patients thought to have anxiety or depression by their GPs are referred to the~     Primary Mental Health Team (PMHEIT) for psychiatric assessment. This assessment consists of a~     one-hour interview with a senior psychiatry registrar or psychiatrist, who then writes a~     letter to the referring GP. The letter contains diagnostic information and management~     recommendations. It is not current practice to send a copy of this letter to the patient. We~     hypothesize that patients who receive a copy of the psychiatric assessment letter that is~     sent to GPs will improve adherence to treatment recommendations; and that patients who~     receive a copy of the letter will have improved outcomes.~      GPs will be asked to agree to the participation of their patients. Participants will be~     persons over the age of 18 years who are referred to the PMHEIT for assessment and who~     receive primary diagnoses of depression or anxiety. After the assessment interview, the~     patient will be given an explanatory letter and a consent form. Consenting patients will~     complete the Depression and Anxiety Stress Scales (DASS) and a SF12 questionnaire to measure~     the level of disability they are experiencing due to their mental condition.~      Participants will be randomly allocated into two groups: a control group who will not receive~     a copy of the assessment letter, and an experimental group who will be mailed a copy of the~     same information that their GP receives. The registrar who conducts the assessment and writes~     the report will not know to which group each participant has been assigned. Thus, the content~     of the letter will not be affected by knowledge that the patient will or will not see it. The~     letter will be sent simultaneously to the referring GP and to experimental group~     participants. To ensure confidentiality, the letter will be sent by registered mail.~      Three weeks later, participants will be mailed a copy of the DASS. After a week, they will be~     contacted by phone and asked for their DASS responses. They will also be asked a brief series~     of questions regarding their adherence to the treatment recommendations given in their~     assessment letter. When adherence is partial or absent, the interviewer will attempt to~     ascertain the reason. This procedure will be repeated at 3 months, except that assessment on~     the SF12 will also take place.~   "
247937|NCT00307684|"~     Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002~     (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was~     assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a~     developmental disorder beginning in childhood and characterized by developmentally~     inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult~     patients with ADHD is limited, but it is estimated that approximately 50% of children with~     ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS~     methylphenidate. The active ingredient is methylphenidate and the tablet is designed to~     release the active ingredient gradually to ensure an effect, which lasts up to 12 hours.~     Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either~     receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate.~     This 5-week period was followed by a 7-week period, where patients received OROS~     methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete~     42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and~     tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate~     over a long period of time.~      Amendment: At the end of the open-label period of the present study 42603ATT3004, patients~     are enrolled into a double-blind placebo-controlled period, which lasts an additional 4~     weeks. The purpose of this double-blind placebo-controlled period is to evaluate the~     maintenance of effect under continued treatment with OROS methlyphenidate in comparison to~     treatment cessation in those patients, who are randomized into the placebo-group.~   "
247938|NCT00307671|"~     The aim of this trial is to lower the morbidity rate in elderly patients affected with~     systemic necrotizing vasculitides, by reducing mortality and improving global outcome.~   "
247939|NCT00307658|"~     The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing~     remission in patients relapsing of systemic vasculitides.~   "
247940|NCT00307645|"~     The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated~     vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy,~     i.e. in preventing relapses.~      HYPOTHESIS :~      MMF might be more effective than azathioprine as maintenance drug in AASV patients, reducing~     by 50% relapse rate, with a same frequency of adverse effects~   "
247941|NCT00307632|"~     The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control,~     compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine~     and ethinyl estradiol (NLGM / EE).~   "
247942|NCT00307619|"~     The purpose of this study is to evaluate the effectiveness and tolerability of topiramate~     compared to placebo in patients with binge eating disorder receiving Cognitive Behavior~     Therapy (CBT)~   "
248161|NCT00304694|"~     18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively~     detect subclinical and clinical therapeutic responses at stages that are earlier than those~     detected by conventional approaches.~      We propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET~     before and after induction chemotherapy for locally advanced NPC patients.~   "
247943|NCT00307606|"~     Background Seroma formation is a common problem after mastectomy. The incidence various~     between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and~     repeated skin puncture is necessary to remove the seroma. In addition to many ambulatory~     visits this also leads to an increased risk of infection, and the adjuvant treatment can be~     delayed for several weeks~      Different procedures have been tried to avoid seroma formation. Among these are for ex. :~     immobilisation of the arm and shoulder after mastectomy, different drain regimens, closing of~     the dead space of the cavity, different chemical substances as thrombin, tranexamacid and~     fibrin. Non of these results has been successful.~      Seroma formation is most likely the result of the inflammatory response due to wound healing.~     In the seroma fluid several factors have been detected that support this assumption. These~     factors are: high levels of IgG, leucocytes, granulocytes, proteinases, proteinases~     inhibitors, different kinds of cytokines ( tPA, uPA,, uPAR, PAI-1, PAI-2, IL-6 og IL-1).~      On the basis of this, an inhibition of the inflammatory response might result in a decrease~     of seroma formation, and perhaps improve quality of life after mastectomy.~      Steroids inhibit the inflammatory response for example by inhibition of the cytokine~     function. It has been shown that a high single dose of steroid infusion (30mg/kg solu-medrol)~     inhibits the normal IL 6 response after colon resection. Newer studies have shown that even~     at a lower dose the inflammatory response is inhibited. In several studies of head and neck~     surgery the oedema in surgical area is reduced after a single dose of 125 mg solumedrol. It~     is precisely this effect of reduced fluid formation we want to obtain in our study. We have~     therefore chosen to use a single dose of 125 mg of solumedrol in this study. Even at the~     largest single dose of glucocorticoids there have not been seen any increasing in surgical~     complications.~      The aim of the study: To find out whether single dose of glucocorticoid can reduce the seroma~     formation after mastectomy~      Study design : A randomised pilot study, with 2 x 20 patients. 125 mg solumedrol is given 1,5~     hours before surgery in 20 patients, and the other 20 patients are the control group~      Inclusion criteria: Women with primary breast cancer, undergoing a mastectomy with either~     sentinel node biopsy or complete axillary dissection.~   "
247944|NCT00307593|"~     The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of~     relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated~     vasculitides.~   "
247945|NCT00307580|"~     This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at~     ~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs~     (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)~     were to be treated with up to two serially instilled doses of Cathflo Activase.~   "
247946|NCT00307567|"~     Booster and immune memory study~   "
247947|NCT00307554|"~     Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals'~     10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.~   "
247948|NCT00307541|"~     Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one~     month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months~     of age~   "
247949|NCT00307528|"~     As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the~     safety and the immune response of the new investigational pneumococcal protein vaccine is~     evaluated in healthy elderly population.~   "
247950|NCT00307515|"~     A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical~     practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or~     intra-abdominal surgery.~   "
247951|NCT00307502|"~     The purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside~     analog reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs), and the~     influence of the individual characteristics on the pharmacokinetic parameters in the Spanish~     population of HIV-infected subjects.~   "
247952|NCT00307489|"~     This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once~     daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg~     (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera)~     for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus~     deoxyribonucleic acid [HBV DNA]).~      Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind~     treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of~     open-label FTC/TDF which may be continued through the end of the 168-week treatment period if~     there is a virologic response (HBV DNA < 400 copies/mL). Alternatively, subjects with~     confirmed HBV DNA < 400 copies/mL at or any time after Week 24 of double-blind treatment may~     continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the~     investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in~     subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may~     discontinue the study and begin commercially available HBV therapy rather than initiate~     open-label FTC/TDF.~   "
247953|NCT00307476|"~     Primary: To determine the effectiveness of the rectal trumpet compared to the standard care~     in maintaining skin integrity in patients with fecal incontinence.~      Hypothesis (H1): There will be no difference in the failure rates of rectal area skin~     integrity between subjects receiving the rectal trumpet and those receiving treatment as~     usual (staqndard care).~      Secondary: To determine the ease of use, cost-effectiveness, and level of patient comfort~     with the rectal trumpet compared to the standard care in patients with fecal incontinence.~      Secondary (exploratory) hypotheses:~      There will be differences in the ease of use of the devices, costs of the devices, and~     patient comfort relative to the devices.~   "
247954|NCT00307463|"~     This study aims mainly to investigate the effects of two approaches to control blood pressure~     in hypertensive hemodialysis patients; using antihypertensive drugs versus strict volume~     control (by strict dietary salt restriction and persistent ultrafiltration) without using~     antihypertensive drugs on cardiac structure and inflammation.~   "
247955|NCT00307450|"~     The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced~     dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with~     levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the~     modified AIMS.~   "
247956|NCT00307437|"~     The primary objective of this study is to evaluate the efficacy and safety of ustekinumab~     (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.~   "
247957|NCT00307424|"~     AutoCPAP would lead to better compliance than FixCPAP~   "
247958|NCT00307411|"~     Investigating the effect of low dose growth hormone therapy on body fat composition, insulin~     sensitivity and metabolic profiles in middle-aged men with metabolic syndrome and low~     insulin-like growth factor (IGF-1) level.~   "
247959|NCT00307398|"~     A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg~     or sham administration every 6 months.~   "
248386|NCT00301600|"~     A single-center random parallel study to compare the efficacy and safety of Mycophenolate~     mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA~     nephropathy~   "
247960|NCT00307385|"~     This study will examine whether hand movement in stroke patients can be improved by applying~     electrical stimulation to the side of the brain affected by the stroke. It will compare the~     effects of similar brain stimulations in stroke patients and healthy volunteers.~      Healthy, right-handed normal volunteers and stroke patients between 18 and 80 years of age~     may be eligible for this study. Patients' stroke must have occurred at least 3 months before~     entering the study and affect one side of the brain only. Candidates are screened with a~     medical history, brain MRI, and evaluation of memory and attention span. Pregnant women are~     excluded from the study.~      The study involves seven 2-day sessions over the course of about 8 weeks, with each session~     separated by at least 1 week. During each session participants practice a pattern of hand~     movements and their accuracy in performing the movements is evaluated before and after brain~     electrical stimulation. The movements include a complex finger sequence, a simple finger~     sequence, a peg test (placing wooden pegs in holes on a board), a hand function test (turning~     over cards, picking up small objects with one hand and placing them in a can, picking up~     small objects with a spoon and placing them in a can, stacking checkers, moving light cans,~     and moving heavy cans), and a box and block test (picking up and moving blocks from one box~     to another).~      The first day of each 2-day session lasts about 5 hours and includes the following:~        -  TMS measurements: A wire coil is held on the scalp, and a brief electrical current is~          passed through the coil, creating a magnetic pulse that stimulates the brain. During the~          stimulation, the subject may be asked to tense certain muscles slightly or perform other~          simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg,~          and the subject may hear a click and feel a pulling sensation on the skin under the~          coil.~        -  tDCS: Small, wet sponge electrodes are applied to the head - one above the eye and the~          other on the back of the head. A small electrical current is passed between them. The~          subject may feel an itching or tingling sensation under the electrodes or see light~          flashes. Some sessions are done with sham tDCS.~        -  Motor learning under tDCS: tDCS is repeated while the subject performs different finger~          movements. A new pattern of finger movements is taught each session.~        -  Surface electromyography: Electrodes are filed with a conductive gel and taped to the~          skin over one small hand muscle to measure the electrical activity of muscles.~        -  Behavioral measurements: Evaluation of learned movement tasks~        -  Questionnaires to evaluate the subject's attention, fatigue and mood before and after~          testing~      The second day of each session lasts about 2 hours and includes the TMS measurements and~     behavior measurements.~   "
247961|NCT00307346|"~     This study will compare electroencephalograph (EEG) recordings in healthy volunteers and in~     people with movement disorders to examine brain activity associated with the weakness. EEG~     records the electrical activity of the brain (brain waves).~      Healthy volunteers and patients with arm or leg weakness who are between 18 and 80 years of~     age may be eligible for this study. Healthy subjects are screened with a medical history,~     physical and neurological examinations, and a questionnaire. They must be right-handed and~     never have had a neurological disease or head trauma.~      All participants have an EEG. An elastic cap with electrodes is placed on the subject's scalp~     to record the brain's electrical activity. During the EEG, subjects are required to resist~     against a force with their arm, elbow, shoulder or leg for as long as they can. Several~     recordings are done with short breaks between them.~   "
247962|NCT00307333|"~     Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC)~     will require intubation and mechanical ventilation as a result of sepsis and sepsis-like~     illness.~      Infants will be randomly assigned to one of two groups. One group of infants will have the~     HRC index known to the physicians caring for them, and physicians will use the HRC index as~     they desire to aid in clinical management.~      Infants in the other group will have the HRC index recorded, but this information will not be~     displayed to the physicians caring for the infants.~   "
247963|NCT00307320|"~     Researchers at UVa Health System are interested in how women experience and deal with stress~     during pregnancy. Participants will be randomly assigned either to engage in coping~     strategies on one's own or to receive 6 weeks of relaxation training. Researchers will~     examine how coping strategies affect the course of the pregnancy and the health of the infant~   "
247964|NCT00307307|"~     The primary objective of this randomized, double blind, placebo controlled pilot study is to~     determine if therapies aimed at lowering LDL cholesterol (HMGCoA reductase inhibitor –~     simvastatin) or increasing HDL cholesterol (Niaspan) will induce regression of carotid~     atherosclerotic plaque in vivo using MRI imaging techniques. MR plaque morphology at baseline~     will be compared to that after 6 and 12 months of therapy and changes in MR characteristics~     will be compared to changes in lipoprotein parameters and urinary isoprostanes. The effect of~     moderate LDL reduction, aggressive LDL reduction and the combination of aggressive LDL~     reduction and HDL elevation on MRI plaque characteristics will be compared by randomly~     assigning subjects (n=69) with carotid disease (>30% stenosis by ultrasound criteria) to one~     of three treatment arms;~        1. Simvastatin 20 mg daily and placebo Niaspan (n=23)~        2. Simvastatin 80 mg daily and placebo Niaspan (n=23)~        3. Simvastatin 20 mg daily and active Niaspan (n=23) Treatment group 2 and 3 will have~          roughly equivalent LDL lowering because of the synergistic LDL lowering effect of the~          combination of simvastatin and Niaspan.~   "
247965|NCT00307294|"~     The primary objective of this study is to evaluate PSA response rates of the combination of~     Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary~     objectives include: 1) To evaluate the clinical response rate of this combination on~     measurable disease 2) To evaluate overall survival for this combination.~   "
247966|NCT00307281|"~     The Comprehensive Lung Center (CLC) at the University of Pittsburgh Medical Center (UPMC~     Health System) provides patients with any type of breathing or lung disorder a full range of~     diagnostic and therapeutic services. The Emphysema Research Center (ERC) is a specialty~     clinic, within this center, that attempts to advance the understanding of emphysema and to~     evaluate new therapies for patients with emphysema. The Emphysema Research Registry will~     enable pulmonary research physicians to: 1) gather information and create a research registry~     of people who have been diagnosed with emphysema; 2) utilize this research registry with the~     purpose of conducting research that attempts to advance the understanding of emphysema and to~     evaluate new therapies; and, 3) use the research registry to identify potential candidates~     for future research programs. These aims will be achieved by the collection of DNA (genetic~     material)for analysis and storage in addition to pulmonary function tests and other medical~     information.~   "
247967|NCT00307268|"~     To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that~     the effectiveness is lower than efficacy outcomes measured in clinical trials~   "
247968|NCT00307255|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel~     albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating~     patients with advanced metastatic solid tumors.~   "
248162|NCT00304681|"~     The purpose of this study is to determine the effectiveness and safety of~     OROS*methylphenidate/CONCERTA* vs. immediate release methylphenidate as a treatment for ADHD~     specifically for those children who have behavioural difficulties in the~     afternoon/after-school and evening periods.~   "
247969|NCT00307242|"~     In earlier clinical studies, when patients who have been on lamivudine (LAM) were switched to~     adefovir dipivoxil (ADV), some patients developed ALT flares with an elevation of ALT > 10 x~     the upper limits of normal (ULN).~      There were no cases of hepatic decompensation with the flares, however. The transition~     methods were varied among physicians from no overlapping to overlapping for 1 to 3 months~     with LAM and ADV. There is still some uncertainty about the optimal approach to switching~     from LAM to ADV.~      This study will compare the safety of directly switching to ADV to a protocolled switch after~     a period of overlap of 12 weeks. This will facilitate pro-active switching in patients on LAM~     and will also highlight genotypic resistance ahead of phenotypic resistance as a reason to~     switch patients. Data to date have only been presented as part of a controlled study in~     patients with clinically evident LAM-resistance. This study will enroll patients who still~     have serum hepatitis B virus (HBV) DNA suppression whilst receiving LAM.~   "
247970|NCT00307229|"~     To determine the maximum tolerated dose and/or maximum attainable dose of a vaccine~     consisting of adenovector expressing rat Her-2/neu in patients with metastatic or locally~     recurrent breast cancer.~   "
247971|NCT00307216|"~     This study will determine the effectiveness of the Graduated Recovery Intervention Program, a~     manual-based individual therapy program, in enhancing the clinical benefit of routine~     treatment for individuals recovering from their first episodes of psychosis.~   "
247972|NCT00307203|"~     Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic~     population often find it difficult to quit smoking. The purpose of this trial is to determine~     the safety and effectiveness of bupropion in treating individuals with schizophrenia who~     smoke.~   "
247973|NCT00307190|"~     This study will determine whether the disturbances in cholecystokinin release and gastric~     emptying that occur in people with binge eating disorder are similar to those that occur in~     people with bulimia nervosa.~   "
247974|NCT00307177|"~     The purpose of this research is to compare reactions and antibody responses following receipt~     of different doses of the experimental influenza vaccine or standard influenza vaccine.~   "
247975|NCT00307164|"~     Lipoatrophy, the loss of body fat from particular areas of the body, is a common side effect~     of antiretroviral therapy (ART). The purpose of this study was to determine the effectiveness~     of uridine supplementation in treating HIV infected individuals on stable ART with~     lipoatrophy.~   "
247976|NCT00307151|"~     A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a~     single dose to her infant has been shown to be an effective way of reducing the risk of~     mother-to-child transmission (MTCT) of HIV. The purpose of this study was to compare the~     effectiveness of a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based~     antiretroviral regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants~     who had or had not been exposed to SD NVP for prevention of MTCT.~      >>~      >> A five year follow up has been added to the study.~   "
247977|NCT00307138|"~     There has been continuing debate about whether use of hetastarch for volume replacement in~     coronary artery bypass surgery [CABG] increases the risk of postoperative bleeding. A recent~     meta-analysis of hetastarch use in on-pump CABG concluded that use of hetastarch in these~     procedures is associated with increased risk, but the safety of hetastarch use in off-pump~     procedures remains unresolved.~      We designed a double-blinded randomized clinical trial to investigate this question. The~     study was designed as an equivalence trial. Statistical power calculations were performed~     taking this into consideration. Sealed assignments from a block randomization table developed~     prior nto initiation of the trial were unsealed in the operating room. These were used to~     assign patients scheduled for off-pump CABG to receive either 1 L of hetastarch or 1 L of~     albumin as part of intraoperative volume replacement. Albumin was used for all subsequent~     intraoperative and postoperative fluid replacement.~      The rate of postoperative bleeding was assessed prospectively by monitoring hourly chest tube~     drainage and number of units of blood products transfused postoperatively in the Intensive~     Care Unit. Risk was assessed by a Data Safety Monitoring Committee (DSMC) established for~     this trial. The SAMC was scheduled per protocol to meet after the first 15 subjects (both~     groups combined) had 1000cc or more of chest tube drainage in the first 12 hours~     postoperative, and then subsequently either after 15 additional bleeds of this volume or~     following a schedule set at the discretion of the DSMC.~      The trial was continued until 156 patients had been recruited. At that time, 78 participants~     each had been assigned to the hetastarch and albumin groups. DSMC review at that time~     determined that use of hetastarch is associated with a risk of postoperative bleeding which~     is greater than the risk associated with use of albumin and the DSMC accordingly halted the~     trial.~   "
247978|NCT00307125|"~     The purpose of this study is to determine whether treatment with rituximab (anti-CD20,~     Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney)~     transplant will promote longer-term survival of the transplanted kidney.The pilot study~     compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to~     placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA~     antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after~     transplant.~   "
247979|NCT00307112|"~     A bacterium called Group A Steptoccoccus or strep is commonly found in the nose and throat~     of healthy adults and children and can cause a variety of illnesses. If this bacterium~     infects another part of the body one or more times, children may get Rheumatic heart disease~     (RHD). The purpose of this community based study is to see how many children between 5-15~     years of age have RHD in Leon, Nicaragua. The study will also help to determine if the usual~     methods of detecting this disease are working. Researchers hope that this study will help to~     develop vaccines that may prevent strep infections to Nicaragua and other parts of the~     world. About 3,600 children will take part in the study. The children will participate for a~     minimum of 1 day and have a 6 month follow-up visit if they are identified as possible or~     probable RHD cases. Study procedures will include clinical exams and echocardiograms to~     determine the presence of RHD.~   "
247980|NCT00307099|"~     This study will enroll 460 subjects who have new pulmonary infiltrates during their ICU stay~     and who are at low risk of having pneumonia, as determined using the Clinical Pulmonary~     Infection Score (CPIS). The study is designed to determine whether 3 days of antibiotic~     treatment with meropenem (with or without coverage for MRSA) for ICU subjects diagnosed with~     new pulmonary infiltrates can reduce the emergence of anti-microbial-resistant organisms and~     the isolation of a potential pathogen compared to a standard course of antibiotic therapy~     (minimum of 8 days of therapy with antibiotics of the primary care team's choosing). Subjects~     will be randomly placed in either the meropenem group or standard antibiotic therapy group.~     The study will also examine whether short-course therapy reduces hospital length of stay and~     hospital cost, without having a negative effect on subject morbidity and mortality.~   "
248163|NCT00304668|"~     Approximately 42 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each~     volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo. The~     volunteers will receive investigational product for a total of 42 days.~   "
247981|NCT00307086|"~     The primary objectives of this study are to:~        -  To determine the maximum tolerated dose (MTD) of bortezomib in combination with~          high-dose melphalan as a conditioning regimen.~        -  To determine the safety, tolerability, and response rates of bortezomib given in~          combination with high-dose melphalan, as a conditioning regimen, for tandem transplants~          in patients with primary refractory multiple myeloma or plasma cell leukemia.~      The secondary objectives of this study are to:~        -  To determine gene expression profiles (pharmacogenomics) and perform RTPCR for Fanconi~          anemia pathway genes, prior to and after treatment with bortezomib, in patients with~          primary refractory multiple myeloma and plasma cell leukemia and correlate profiles with~          responses to treatment.~        -  To determine the time to disease progression and overall survival in patients with~          primary refractory multiple myeloma and plasma cell leukemia treated with bortezomib~          followed by tandem autologous transplantation~        -  To determine the response rates of 2 cycles of bortezomib in patients with primary~          refractory multiple myeloma or plasma cell leukemia~   "
247982|NCT00307073|"~     Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some~     pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart~     beat too fast or too slow). Advances in pacemaker technology in recent years include features~     that automatically adapt to patient conditions without intervention from the clinician.~     Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity~     advances by including the managed ventricular pacing (MVP) feature designed to promote~     intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary~     ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a~     feature called TherapyGuide that is designed to allow the user to select certain conditions~     for each subject and receive a list of suggested pacemaker parameter value changes based on~     those conditions. The purpose of this study is to evaluate the overall system safety and~     clinical performance of the Adapta pacing system.~   "
247983|NCT00307060|"~     To compare the blood pressure lowering efficacy, safety and tolerability of a combination~     drug to a single drug taken once daily in patients with uncontrolled blood pressure following~     a 4-week filter on the single therapy product.~   "
247984|NCT00307047|"~     The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and~     efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V®~     arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™~     Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston~     Scientific.~      TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston~     Scientific.~   "
247985|NCT00307034|"~     Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of~     age) and after the complete 2, 4, 11 months schedule when co-administered with~     DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)~   "
247986|NCT00307021|"~     GSK Biologicals is developing a number of candidate malaria vaccines for the routine~     immunization of infants and children living in malaria-endemic areas. The candidate vaccines~     are designed to offer protection against malaria disease due to the parasite Plasmodium~     falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection~     against infection with hepatitis B virus (HBV). This study will evaluate two candidate~     vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment~     Act, Sep 2007.~   "
247987|NCT00307008|"~     Streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of~     humans. However, these bacteria can also cause severe infectious diseases such as pneumonia,~     septicemia and meningitis. Elderly subjects are especially vulnerable to these infections,~     and the diseases can result in death. The currently available licensed Streptococcus~     pneumoniae vaccine is recommended for prevention of pneumococcal diseases in individuals over~     the age of 65. However, the antibody level elicited by this vaccine, is not always~     satisfactory in elderly people. To overcome the problem, GlaxoSmithKline Biologicals is~     currently developing candidate vaccines that are hoped to work better than the currently~     available vaccines. As a first step in this development, the present study is being conducted~     in order to evaluate the immune response to the currently marketed vaccine.~   "
247988|NCT00306995|"~     Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which~     most of the population lacks immunity. If such virus is pathogenic to human and demonstrates~     the ability to transmit from person to person, the result is a global outbreak of disease~     that affects a high percentage of individuals in a short period of time and is likely to~     cause substantially increased mortality and morbidity in all countries of the world.~     Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have~     been directly transmitted to humans, raising concern over the possibility of a new influenza~     pandemic among the world's immunologically naive populations. In order to face this kind of~     situation, a pandemic influenza vaccine has to be developed.~   "
247989|NCT00306982|"~     This study will investigate the incidence of influenza, disease and various possible~     downstream complications and hospitalizations or emergency room visits after routine annual~     vaccination of the elderly population with Fluarix™.~   "
247990|NCT00306969|"~     This is a pilot study of the safety and tolerability of photopheresis in combination with~     increasing doses of oral bexarotene in patients with cutaneous T-cell lymphoma.Our hypotheses~     are that the combination of bexarotene with photopheresis is safe and that bexarotene will~     enhance immune response in the setting of extracorporeal photopheresis in the treatment of~     cutaneous T-cell lymphoma (CTCL), resulting in a shorter time to clinical response.~   "
247991|NCT00306956|"~     The purpose of this study is to determine if the introduction of pacifier use to infants at 2~     weeks of age, once breast feedings are well established, will affect the incidence and~     duration of successful breastfeedings.~   "
247992|NCT00306943|"~     A pre-requisite to the yearly licensing process of the Influenza vaccine (FluarixTM/~     Influsplit SSW®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity~     of the vaccine composed of the new strains (2005/2006).~   "
247993|NCT00306930|"~     This study is a clinical evaluation of survivorship of an acetabular cup system after total~     hip replacement using patient examinations and questionnaires.~   "
247994|NCT00306917|"~     Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip~     arthroplasty~   "
247998|NCT00306865|"~     This study will examine how chemical changes in the brain produce symptoms of hand dystonia.~     Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive~     movement or abnormal postures. In focal dystonia, just one part of the body, such as the~     hand, neck or face, is involved. The study will use positron emission tomography (PET) to~     find our which areas of the brain in patients with focal hand dystonia differ from healthy~     volunteers without focal hand dystonia.~      Healthy volunteers and patients with focal hand dystonia between 18 and 65 years of age may~     be eligible for this study. Candidates are screened with a medical history and physical and~     neurological examinations.~      Participants undergo the following procedures:~        -  PET scanning: The PET scanner is shaped like a doughnut. The subject lies on a bed that~          can slide in and out of the scanner. A custom-molded plastic mask is placed on the face~          and head to support the head and prevent it from moving during scanning. Two radioactive~          substances - five doses (one per scan) of [15 O] water and one dose of [11C] flumazil~          are injected into the body through a vein. The dose of injected radioactive substance is~          very small, and they are not harmful to the body. The [15 O] water doses are injected~          during the first hour and scans are taken every 10 minutes. The [11C] flumazil is~          injected during the second hour. The radioactive substances are detected by the PET~          scanner and provide information on the functioning of the brain chemistry.~        -  MRI scanning: MRI uses a magnetic field and radio waves to produce images of body~          tissues and organs. The patient lies on a table that is moved into the scanner (a narrow~          cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur~          during the scanning process. Scanning time for this study will be less than one hour.~          Subjects may be asked to lie still for up to 10 minutes at a time.~   "
247999|NCT00306852|"~     The purpose of the Tube Versus Trabeculectomy (TVT) Study is to compare the safety and~     efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with~     previous ocular surgery.~   "
248000|NCT00306839|"~     The purpose of the study is to evaluate mid and long term postoperative pain and further~     disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh~     fixation with fibrin sealant (FS), compared to mesh fixation with sutures.~   "
248001|NCT00306826|"~     In patients with impaired glucose tolerance (IGT), the researchers want to study the relative~     effects of pioglitazone, simvastatin, or the combination of both on:~        -  intima media thickness (IMT) as an easily assessed marker of atherosclerosis~        -  heart rate variability (HRV) as a marker of autonomic neuropathy~        -  flow-mediated vasodilatation (FMD) of the brachial artery as a marker of endothelial~          function~        -  vascular and metabolic lab parameters~   "
248002|NCT00306813|"~     This is a multi-center, open label, uncontrolled, non-comparative phase I/II study in~     patients with refractory or relapsed multiple myeloma who are eligible for second, third, or~     fourth line therapy. Patients will be enrolled sequentially into four dose cohorts. The~     feasibility of administrating Revlimid (R) in combination with Doxorubicin and Dexamethasone~     (AD) and the MTD of the combination will be determined in the phase I part of the study (Part~     A). When the MTD has been established, the efficacy of the combination will be further~     evaluated in the phase II part of the study Part B)~   "
248003|NCT00306800|"~     The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with~     methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source~     Aktilite CL128, in treatment of patients with multiple actinic keratosis (sun-damaged skin)~     on the face and / or scalp~   "
248004|NCT00306787|"~     This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day~     (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms~     compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).~   "
248005|NCT00306774|"~     Knee osteoarthritis (OA) is a common and disabling health problem in older adults and for~     which there is no cure. The purpose of this study is to determine the effects of vitamin D on~     knee OA symptoms and physical function in adults aged 45 years and older.~   "
248006|NCT00306761|"~     Cerebral palsy (CP) is a non-degenerative neuromuscular disease that can exist at or occur as~     a result of birth. Because of damage to one or more parts of the brain that control movement,~     an affected child cannot control his or her muscles normally. Prevalence of CP is similar~     worldwide, with pronounced severity in underdeveloped countries due to poor health and~     financial conditions.~      Research should be conducted to find methods of medical treatment to allow affected children~     to maintain or regain musculoskeletal functionality. Many children affected with CP spend~     much of their days restricted to a rigid wheelchair; limiting muscular and cognitive~     development, making it difficult to interact with their environment. The gap to be addressed~     by this study is to determine if a wheelchair that is based on the dynamics of human anatomy~     can allow enhanced function, while being adaptive to individual growth and development. At~     present, there is very little dynamic capability available in commercial wheelchairs to allow~     this mobility.~      A dynamic wheelchair system was recently designed and a small sample of able-bodied children~     has been tested in the chair. It is hypothesized that significant increases in functional~     mobility will be achieved in children with CP from the use of this novel wheelchair design.~   "
248007|NCT00306748|"~     The purpose of this study is to determine the safety and gastrointestinal pharmacodynamics~     (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation)~     of MD-1100 acetate administered daily for 14 days.~   "
248008|NCT00306735|"~     The primary purpose of this study is to explore the efficacy of three different dose~     schedules of palonosetron for the prevention of emesis over a 7-day study interval in~     multiple myeloma patients.~   "
248009|NCT00306722|"~     Very often patients receive medication before a diagnostic, therapeutic, or surgical~     procedure to help them relax, keep them calm, and to relieve them from pain. This is called~     procedural sedation. During procedural (mild-to-moderate) sedation, a patient is first given~     a pain-relief medication (analgesic) and then a medication to help him/her relax and keep~     him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases~     immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is~     made as a slow release version of propofol with a longer duration of effect.~   "
248010|NCT00306709|"~     This is a randomized intervention that examines the effect of culturally adapted weight loss~     program in African American (AA) females age 40-65. Evidence suggests that AA women are more~     successful with weight loss programs that are culturally tailored (Karanja, et al, 2002).~     Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from~     ATP-III and the CHANGE exercise program, which have shown success independently in previous~     clinical trials with AAs.~   "
248011|NCT00306696|"~     Study examining the effect of different diuretics on fluid retention in diabetics treated~     with rosiglitazone.~   "
248012|NCT00306683|"~     In children treated for intracranial lesions, the 2 factors of the obesity are : the location~     of the lesion (hypothalamic-pituitary region) and craniopharyngiomas~   "
248013|NCT00306670|"~     The purpose of this study is to evaluate the rate of response when administering rituximab to~     suppress or eliminate the anti-body in a patient's blood that inhibits the effectiveness of~     their factor replacement product compared to treatment using cyclophosphamide. This is a~     Phase 2/3 study to find out what effects (good and bad) and response rituximab has on a~     patient and their anti-Factor VIII antibodies. Also, to compare the effect (good and bad) of~     the rituximab with cyclophosphamide on a patient and their anti-Factor VIII antibodies to see~     which is better. This research is being done because we do not know which treatment regimen~     (rituximab or cyclophosphamide) is more effective in eliminating or suppressing the~     anti-Factor VIII antibody in patients with acquired Hemophilia A.~   "
248014|NCT00306657|"~     Normal tension glaucoma (NTG) and chronic open angle glaucoma (COAG) occurring progressively~     with optimal conventional or intraocular pressure reducing surgery are still unsolved~     problems in ophthalmology. The investigators would like to investigate whether or not the~     composition of cerebrospinal fluid (CSF) surrounding the optic nerve (ON) in these patients~     is pathologic under certain conditions. They therefore compare the CSF taken during optic~     nerve sheath fenestration with the CSF taken during a lumbar puncture. The investigators'~     hypothesis is that, in patients with NTG and COAG, the composition of CSF surrounding the~     affected ON plays an important role in promoting progressive visual function loss.~   "
248015|NCT00306644|"~     The study investigated the effect of rosiglitazone and placebo on carotid intima media~     thickness in patients with insulin resistance syndrome and/or type 2 diabetes.~   "
248016|NCT00306631|"~     This phase 2 study will determine the antitumor activity, based on the objective rate, of~     oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with~     advanced or metastatic breast carcinoma. The study will also evaluate the safety and response~     duration in patients, time to tumor progression, and overall survival in patients following~     MKC-1 therapy.~   "
248017|NCT00306618|"~     This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well~     as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal~     Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme~     (GBM)~   "
248018|NCT00306605|"~     This study is designed to evaluate the emotional experiences of fathers who have preterm~     infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we~     will compare the emotional responses experienced by father of surgical NICU babies and~     fathers of medical NICU babies.~      Our primary hypothesis is that paternal stress levels will be lower for those fathers of~     infants who are hospitalized in a medical NICU compared with fathers of infants who are~     hospitalized in a surgical NICU.~      Secondary hypotheses include: 1) Stress levels for fathers of hospitalized infants will~     decrease over time; 2) Depressive symptomatology modulates perceived stress in fathers of~     NICU infants.~   "
248019|NCT00306592|"~     The primary objectives of this study are to further evaluate the safety of natalizumab~     (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity~     following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab~     from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS)~     therapies.~   "
248020|NCT00306579|"~     Introduction~      For several years ischemic electrocardiographic (ECG) changes in the acute phase of~     ischemic stroke have been reported. Whether these ECG changes reflect true myocardial~     ischemia remains controversial. So far no study has assessed different markers of myocardial~     ischemia or necrosis in consecutive patients admitted to hospital with an acute ischemic~     stroke.~      Purpose~      The main purpose of this study is to determine the potential burden of reversible and~     irreversible myocardial ischemia in patients with an acute ischemic stroke.~      Patients and methods~      Serial blood samples for measuring troponin T, CK-MB and NT-proBNP are collected in 250~     patients with evidence of an acute ischemic stroke admitted to the Department of Neurology at~     Odense University Hospital. In addition resting 12-lead ECG recordings will be obtained on a~     daily basis, and a 24-hour ST-segment ambulatory monitoring will be performed once within the~     first week of hospitalisation. Finally, myocardial perfusion patterns during rest will be~     evaluated by means of a myocardial perfusion scintigraphy in patients with an elevated~     troponin T level.~      Six months later control measurements of troponin T, CK-MB and NT-proBNP and a 12-lead ECG~     will be obtained.~      Expectations~      The study will contribute with original observations in patients with acute ischemic stroke~     considering the following issues:~        1. The prevalence and characteristics of ECG changes suggestive of myocardial ischemia.~        2. The prevalence of transient ST-segment changes on ambulatory monitoring.~        3. The prevalence and degree of myocardial necrosis as judged from biochemical markers.~        4. The prevalence of reversible and irreversible perfusion defects on myocardial~          scintigraphy.~        5. The prevalence, size and patterns of NT-proBNP.~        6. Whether there is a change in ECG and biochemical markers over a 6-month follow-up~          period.~      The results may have clinical implications regarding early and late treatment as well as~     clinical follow-up of patients recovering from an episode of acute ischemic stroke.~   "
248021|NCT00306566|"~     The purpose of this study is to monitor a specific cellular immune response in melanoma~     patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP~     vaccine.~   "
248022|NCT00306553|"~     The purpose of this study is to evaluate a specific cellular immune response in melanoma~     patients that have been vaccinated with a Melan-A VLP vaccine.~   "
248023|NCT00306540|"~     The purpose of this study is to evaluate how effective quetiapine versus placebo is when~     added to an existing therapy, in reducing the symptoms of PTSD.~   "
248024|NCT00306527|"~     The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset)~     following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells~     or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine~     one year before (2004) in the study V58P4.~   "
248025|NCT00306514|"~     The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads~     to a specific cellular immune response in patients with malignant melanoma at advanced stage~     of the disease.~   "
248057|NCT00306098|"~     SPECIFIC AIMS:~        1. To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes~          Mellitus by islet cell transplantation;~        2. To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1~          Diabetes Mellitus by islet cell transplantation;~        3. To assess long-term safety and function of successful islet cell transplants in patients~          with Type 1 Diabetes Mellitus;~        4. To determine whether the natural history of the microvascular, macrovascular and~          neuropathic complications of Diabetes Mellitus are altered following successful~          transplantation of islet cells; and~        5. To assess the effect of infliximab in preventing early islet destruction, and thereby~          eliminating the need for a second donor's islet cells.~        6. To assess the effect of etanercept in preventing early islet destruction.~        7. To assess the effect of exenatide to improve islet graft function and survival in~          subjects that have returned to using exogenous insulin.~        8. To assess the ability of exenatide to improve islet survival at time of transplantation.~   "
248026|NCT00306501|"~     This study will compare several techniques designed to improve the ability to swallow in~     stroke patients with chronic dysphagia (difficulty swallowing).~      Healthy volunteers 20 to 60 years of age and people 20 to 90 years of age who have had a~     stroke resulting in swallowing problems may be eligible for this study. Volunteers are~     screened with a medical history, physical examination, and urine test for women to rule out~     pregnancy. Stroke patients are screened additionally with a chest x-ray, physical~     examination, cognitive screening, swallowing questionnaires, nasoendoscopy (examination of~     the nasal passages in the back of the throat using a lighted telescopic instrument) and~     FEESST (passage of a thin, flexible telescope through the nose to the voice box),~     videofluoroscopy (x-ray of the head and neck during swallowing) and button press training~     (learning how to press a button on a table in coordination with swallowing).~      All participants undergo the following procedures:~        -  Transcranial magnetic stimulation (TMS): A metal coil is placed on the head and sends a~          pulse of energy to the brain through the scalp. The muscle response to the pulse is~          recorded from the muscles in the throat that are associated with swallowing.~        -  Electromyography: A needle is used to insert tiny wires in specific muscles of the~          throat to record the muscle response to the TMS pulses.~        -  Magnetic resonance imaging (MRI): During brain MRI scanning, subjects lie quietly and~          images of the brain are taken.~      In addition to the above tests, stroke patients undergo the following:~        -  Water test: The subject swallows a small amount of water and the number of times~          required to clear the throat or cough is counted. This test is repeated five times.~        -  Experimental training. Subjects have a total of 12 60-minute training sessions, one~          session a day for up to 5 sessions a week.~             -  Button press training: The subject swallows small amounts of water. A device placed~               on the throat senses when swallowing occurs. The subject learns how to coordinate~               pressing a button on a table in coordination with swallowing.~             -  Vibrotactile stimulator training: A device that uses a buzzing vibration is placed~               on the throat at times during the swallowing training.~             -  Transcranial direct current stimulation (tDCS): Wires attached to sponge electrodes~               are placed on the scalp and over the eye. Small electric currents are delivered to~               areas of the brain involved with swallowing. This is done at times during the~               swallowing training.~      Participants may receive one of several combinations of training approaches; all receive the~     volitional (button-press) training. Within 5 days of completing training, subjects repeat the~     tests. TMS, MRI, MEG and x-ray study of swallowing function are also repeated to see if any~     changes have occurred in the brain or in the ability to swallow after training. Patients are~     contacted by telephone and in writing 3 and 6 months after training for follow-up on their~     swallowing status and oral intake.~   "
248027|NCT00306488|"~     Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic~     treatment of the dry form of age-related macular degeneration. This pilot study of up to 10~     eye drop tolerant participants with bilateral geographic atrophy is designed to characterize~     the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression~     of geographic atrophy area over a two-year period. Participants will have one eye randomized~     to receive the eye drop and the fellow eye will be observed only.~   "
248028|NCT00306475|"~     The major objective of this proposal is to test the hypothesis that the addition of~     divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly~     improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a~     double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or~     schizoaffective disorder.~   "
248029|NCT00306462|"~     Primary Hypothesis:~      Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium~     sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24~     and 32 6/7 weeks' gestation.~   "
248030|NCT00306449|"~     The purpose of the present study is to determine whether weight gain may be prevented by a~     small group seminar-based two-year educational intervention on healthy lifestyle in freshmen~     at the Faculté de médecine de l'Université de Sherbrooke.~   "
248031|NCT00306436|"~     Diabetes is the leading cause of end-stage renal disease in developed countries. Hypertension~     and metabolic control are known to affect the progression of renal deficiency and patient's~     outcome. Our project aims at implementing a multidisciplinary and systematic approach of~     diabetic patients with renal deficiency, and at evaluating the impact of metabolic and blood~     pressure targets as recommended by current guidelines.~   "
248032|NCT00306423|"~     The purpose of this study is to determine whether a rehabilitation program following lumbar~     microdiscectomy influences short-term (4 months) and long-term (up to 5 years)outcomes in~     quality of life, activity and endurance.~   "
248033|NCT00306410|"~     The purpose of this study is to determine the effect of normalization of vitamin D levels on~     bone density, immune and adipocyte function in HIV1-seropositive patients.~   "
248034|NCT00306397|"~     The main purpose of this study is to investigate, whether a steroid free immunosuppressive~     treatment is a valuable alternative in the treatment of de novo kidney transplant recipients~     and if it is possible to withdraw calcineurin inhibitors after 3 months.~   "
248035|NCT00306384|"~     The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD),~     following participation in 1 of 7 controlled studies in patients with type 2 diabetes~     mellitus.~   "
248036|NCT00306371|"~     Acne can be treated with a mid-infrared laser. We demonstrated safety and efficacy using~     lower energy settings in order to make the treatments less painful~   "
248037|NCT00306358|"~     In the present study the design of the vitamin B12 absorption test, CobaSorb, is further~     optimised. We investigate which test – measurement of holotranscobalamin or cobalamins –~     could be used for reflection of vitamin B12 absorption. Furthermore, we prolong the duration~     of vitamin B12 administration in order to determine the final duration of the vitamin B12~     absorption test CobaSorb.~      Seventy-eight healthy individuals (age 21-81 years) are treated with three oral doses of 9~     microgram cyanocobalamin per day for five successive days. Non-fasting blood samples are~     collected on day 1-5 before administration of the first dose of vitamin B12 and on day 8.~     Cobalamins and holotranscobalamin are measured on day 1–5 and 8. The performance of the~     vitamin B12 absorption test will be evaluated in individuals with borderline or low levels of~     holotranscobalamin or cobalamins (below the 75% percentiles) using a change larger than~     2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused~     by absorption of the administered vitamin B12.~   "
248038|NCT00306345|"~     The identification of patients with potential early organ failure is the key in preventing~     admission or readmission to a critical care facility. The primary goal of the Outreach~     Project is to ensure that all patients with threatening organ failure receive appropriate and~     timely treatment in a suitable area; avoid admission to the intensive care unit (ICU); and~     share ICU skills by a partnership in education. The objectives of the study are to determine~     whether the introduction of an intensive care unit based medical emergency team, responding~     to hospital-wide preset criteria of physiologic instability, will decrease the number of~     predefined serious adverse events (SAEs) and to investigate the effects on quality of life~     and costs in a general surgery population.~      Study Hypothesis: The Outreach intervention will decrease the number of predefined serious~     adverse events; increase quality of life; and decrease costs.~   "
248164|NCT00304655|"~     The purpose of this study is to prove safety and efficacy of aripiprazole.~   "
248387|NCT00301587|"~     The purpose of this study is to compare red blood cell folate levels in women who are taking~     oral contraceptives with or without folic acid~   "
248039|NCT00306332|"~     T-cell and B-cell depletion in allogeneic peripheral blood stem cell transplantation by using~     immunomagnetic negative and positive selection procedures~      Background:~      Removal of T-cells from the donor graft (T-cell depletion) offers the possibility for~     prevention of GVHD and subsequently less transplant related morbidity and mortality after~     allogeneic stem cell transplantation (SCT). There are several techniques to deplete T-cells~     from the stem cell grafts e.g. physical, immunological and combined physical / immunological~     separation methods. All these techniques result in a stem cell graft with sufficient CD34+~     stem cells combined with an adequate depletion of T and B cells. CD34+ selected stem cell~     grafts are very pure and do not contain any additional cell populations. In contrast,~     CD3+/CD19+ depleted grafts still contain NK-cells, monocytes and dendritic cells that are~     part of the innate immune system. Theoretically,the presence of these cells may positively~     influence immunological reconstitution and the graft-versus-leukaemia (GVL) effect,~     respectively, resulting in improved outcome after SCT~      Objectives:~      To evaluate the differences in immunological reconstitution, transplant related mortality,~     disease-free survival and overall survival after T-cell depleted allogeneic SCT for~     haematological malignancies using either immunomagnetic CD34+ selection or immunomagnetic~     CD3+/CD19+ depletion using the CliniMACS system in approximately 270 consecutive patients.~      Additionally in this study in 20 consecutive patients the kinetics of NK-cel reconstitution~     and differences in NK-cell repertoire will be monitored. NK-cell mediated anti-tumor~     reactivity will be monitored in patients transplanted with and without NK-cells in the stem~     cell graft (CD3+/CD19+ depletion, versus CD34+ selection). Secondary objectives are to~     evaluate the clinical relevance of minor histocompatibility-specific cytotoxic T-cell~     responses for the GVL effect, the kinetics of NK-cell reconstitution and differences in~     NK-cell repertoire using the different T-cell depletion protocols.~      Design:~      Single center prospective randomised phase III study~      Population:~      Patients eligible for allogeneic SCT according to the standard criteria of our institution~     who will receive an allogeneic T- and B-cell depleted SCT with peripheral stem cells of an~     HLA-identical sibling donor or an HLA-identical unrelated voluntary (VUD) donor.~      Intervention:~      T-cell depletion will be conducted using two different techniques: either immunomagnetic~     CD34+ selection or immunomagnetic CD3+/CD19+ depletion.~      Endpoints:~      Primary endpoints are immunological reconstitution, relapse, disease free survival and~     overall survival. Secondary endpoints: NK-cell reconstitution and NK-cell mediated~     anti-tumour reactivity. Cytotoxic T-cell responses for the GVL effect.~      Estimated efforts and risks for participating patients:~      We don't expect any extra patient efforts or risks because T-cell depletion is a standard~     procedure in our clinic for many years. There is extensive experience with immunological~     T-cell depletion techniques. We hypothesize CD3+/CD19+ depletion will favour stem cell~     transplant outcome. Immunological and molecular biological studies will be performed on blood~     samples already obtained as part of the standard protocol.~   "
248040|NCT00306319|"~     Pharmacokinetic study in TB patients to determine the effect of rifampicin on the~     pharmacokinetic profile of moxifloxacin.~   "
248041|NCT00306306|"~     Radiographic contrast agents are administered to all patients undergoing diagnostic or~     interventional catheterization procedures. Injection of contrast enables visualization of the~     vasculature with X-ray based fluoroscopy or cineangiographic imaging. Unfortunately, the use~     of radiographic contrast agents is often associated with severe adverse side effects,~     including acute kidney failure. Acute kidney failure following exposure to an intravascular~     contrast agent is also known as Radiocontrast Nephropathy (RCN).~      Physiologic factors that may put a patient at higher risk of developing RCN include:~     pre-existing renal insufficiency, diabetes mellitus, age, cardiovascular disease~     (particularly congestive heart failure and low ejection fraction), and dehydration or other~     conditions characterized by depletion of effective circulatory volume. These risk factors are~     relatively common in patients undergoing catheterization procedures. Treatment of high-risk~     patients can be modified, by hydration and/or minimizing contrast volume; however despite~     these efforts, RCN remains a well-recognized complication of coronary catheterization~     procedures.~      Given the frequency and detrimental consequences of RCN, there is a compelling clinical need~     for safe and effective therapies to reduce the incidence of RCN. One such potential therapy~     is endovascular cooling to induce mild hypothermia. This study has been designed to evaluate~     whether endovascular cooling can reduce the incidence of RCN in high-risk patients who are~     undergoing diagnostic or interventional catheterization procedures.~   "
248042|NCT00306293|"~     Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days~     in a two-way crossover study with a washout period of 7 days in between.~   "
248043|NCT00306280|"~     This purpose of this study is to determine whether phototherapy can be used to safely and~     effectively treat H pylori.~   "
248044|NCT00306267|"~     The purpose of this study is to assess the safety and effectiveness of PROCRIT (Epoetin alfa)~     administered by injection subcutaneously (SC, under the skin), at a dose of 80,000 U once~     every four weeks or 40,000 U once every two in anemic patients with cancer not receiving~     chemotherapy or radiation therapy.~   "
248045|NCT00306254|"~     To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin~     in preventing blood clots in the lungs or deep leg veins of patients after knee surgery~   "
248046|NCT00306241|"~     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.~     Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can~     lead over time to cervical cancer in women . This study will evaluate the immune response~     induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
248047|NCT00306228|"~     The conceptual hypothesis of this study is that, in patients with acute myocardial infarction~     and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit~     artery with paclitaxel eluting stent significantly reduces the rate of restenosis in~     comparison with bare stents.~      The conceptual hypothesis of this study is that, in patients with acute myocardial infarction~     and ST-segment elevation, the strategy of performing coronary stent-angioplasty of the~     culprit artery under the protection of tirofiban 120 minutes after fibrinolytic significantly~     improves epicardial and myocardial infusion in comparison with the strategy of performing~     immediate intravenous thrombolysis (tenecteplase plus enoxaparine) followed by coronary~     angiography and adequate revascularization.~   "
248048|NCT00306215|"~     The purpose of this study is to determine whether CCX282-B is effective in treating patients~     with moderate to severe Crohn's Disease.~   "
248049|NCT00306202|"~     The purpose of this clinical research study was to establish a recommended phase 2 once daily~     (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or~     refractory (resistant to previous treatment) leukemia in children and adolescents. The side~     effects that this oral investigational drug may have in children, and the levels of the drug~     in the blood, will be studied at different doses.~   "
248050|NCT00306189|"~     The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment~     on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60~     and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared~     with those treated with placebo over 12 months.~   "
248051|NCT00306176|"~     The aim of the present study is to investigate the influence of systemic exercise,~     rosiglitazone administration and combined pharmaceutical and lifestyle intervention on~     cardiovascular risk factors~   "
248071|NCT00305903|"~     This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible~     patients will receive open-label treatment with rivastigmine capsules plus memantine tablets~     as add on therapy. This study is designed to evaluate the safety and tolerability of add on~     therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)~   "
248058|NCT00306085|"~     Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic~     limbs has been shown to improve collateral vessel formation. In the present study the safety~     and feasibility of autologous blood mononuclear cells implantation will be investigated in~     patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in~     the ankle-brachial pressure index (ABI:>0.1), ischemic ulcers and angiography as well as~     laser doppler flow will be evaluated until six months.~   "
248059|NCT00306072|"~     The purpose of this study is to evaluate two levels of the herbal extract Salacia oblonga~     (salacinol) on postprandial glycemia and insulinemia in patients with Type 2 diabetes after~     ingestion of a high-carbohydrate control meal.~   "
248060|NCT00306059|"~     Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney~     injury~   "
248061|NCT00306046|"~     18 F-fluoride Positron emission tomography (PET) is able to demonstrate and quantify the~     metabolic activity locally in the skeleton (1). This technique should, therefore, also be~     able to demonstrate a dramatic decrease in the metabolic activity in localized monostotic~     Paget’s disease lesions after therapy. In this condition, indeed, the usual biological~     markers may be unhelpful to assess the efficacy of therapy, because they are usually~     comprised in the normal range for single pagetic localizations, even before therapy (2). The~     main purpose of this trial is to assess the early and long term response of pagetic bone to~     bisphosphonate therapy.~   "
248062|NCT00306033|"~     This study is a double-blind, placebo-controlled, randomized clinical trial to determine~     whether IVIG is effective in improving motor scores in patients with myasthenia gravis and~     worsening weakness.~   "
248063|NCT00306020|"~     Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high~     systemic dosages of opioids. Yet, many patients continue to report pain while experiencing~     dose-limiting side effects. An alternative approach to systemic administration is to apply~     topical medications. The advantage of topical application is the potential of achieving good~     analgesia using low dosages with few, if any, systemic side effects. Current clinical data~     indicates, that topically applied morphine has an analgesic effect in patients with severe~     pain and that it may even improve wound healing. The clinical reports so far have been either~     case studies or double blind randomly controlled trials with a very small sample size of~     patients. There is still a great deal of information which is lacking about this modality of~     treatment regarding on the one hand, the mechanism of action and on the other, clinical~     issues. For example, is the mechanism of the effect actually peripheral? What is the adequate~     dose of analgesic medication for different types of skin conditions? Wound healing has not~     been quantified.~      We will apply morphine topically to skin wounds of cancer and evaluate the effect of the~     treatment on pain, side effects, quantify wound healing, quantify morphine and its~     metabolites in blood and urine.~      Should well controlled studies, demonstrate all or any of the peripheral effects of topical~     morphine, clinical application of this treatment modality would be possible. This could~     contribute towards better treatment of these patients, who have pain which is difficult to~     treat and can, at times, be intractable.~   "
248064|NCT00306007|"~     The aim of the study is to evaluate the reliability, validity, and acceptability of the~     London Measure of Unplanned Pregnancy (LMUP) in a U.S. population of women. The researchers~     hypothesize that the LMUP will be acceptable to a U.S. population and will be reliable and~     valid.~   "
248065|NCT00305981|"~     Family members have poor overall understanding of ICU patients’ prognosis, resuscitation~     status and care, defined a priori as less than 75% correct responses to the yes/no ICU care~     questions.~      Family members of all adult patients admitted to an intensive care of San Francisco General~     Hospital will be screened for enrollment and recruited sequentially over a period of nine~     months (August 1, 2005-March 31, 2006). We will determine the frequency of family members’~     correct responses to the survey questions about ICU care. Family member responses will be~     compared to the chart and real-time patient observation reality (gold standard).~      Hypothesis # 2 Poor English language comprehension and low education level (defined as not~     having completed high school) are risk factors for poor ICU care understanding and knowledge.~      During their surveys family members will be asked questions regarding their English language~     comprehension and education level. Association of these possible risk factors with low level~     of ICU care knowledge will be tested primarily using analysis of variance. Should our~     hypothesis #2 prove to be correct, our future goal will be to develop recommendations for~     interventions to increase understanding specific for these high risk groups. One of these~     interventions is described in Hypothesis #3 below.~      Hypothesis # 3 Provision of the results of family members’ knowledge assessment to health~     care providers will result in improved ICU care knowledge on subsequent testing.~      Subjects will be randomized to two groups—one group’s health care providers will be shown the~     results of family members’ initial ICU knowledge assessment; the other group’s providers will~     not be given these results. One to two days after providing this summary to providers, all~     randomized subjects will undergo a second interview assessing their ICU care knowledge.~     Changes in the frequency of correct responses between the two groups will be compared using~     mean differences in proportions with 95% confidence intervals.~   "
248066|NCT00305968|"~     About 10% of the population in western countries suffer from abdominal pain and change of~     bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of~     life and they are often not well taken care of within the public healthcare system. They~     often feel frustrated and seek both their family doctors, specialists and alternative~     medicine for help. Many patients feel they do not know enough about their disease, and the~     uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information~     and education in these patients.~   "
248067|NCT00305955|"~     The purpose of this study will be to:~        -  Determine the amount of visual acuity improvement with treatment of presumed bilateral~          refractive amblyopia~        -  Determine the time course of visual acuity improvement with treatment~   "
248068|NCT00305942|"~     This proposed phase II trial will investigate the combination of topotecan/carboplatin in the~     first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are~     emerging as common treatments for patients with extensive-stage disease. This trial will be~     one of the first clinical trials to evaluate a combination of weekly topotecan and~     carboplatin in the first-line treatment of extensive-stage SCLC.~   "
248069|NCT00305929|"~     This is a multi-centre, phase II, open-label, 12-month clinical trial for patients previously~     treated with WST09 (Tookad) who have positive prostate biopsies for cancer.~      The study aims at delivering a second WST09 treatment for the purpose of eradicating the~     localized prostate cancer.~   "
248070|NCT00305916|"~     Conventional coronary angiography is the recommended procedure in detection of coronary~     stenosis in patients with idiopathic cardiomyopathy. The aim of this prospective study is to~     assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in~     patients with idiopathic cardiomyopathy in sinus rhythm, compared to conventional coronary~     angiography.~   "
248072|NCT00305890|"~     Osteoarthritis (OA) occurs when the cartilage between two bones becomes worn down, and the~     bones begin to rub against each other in the joint. This often leads to pain, swelling,~     decreased joint motion, and the formation of bone spurs (tiny growths of new bone). Being~     overweight increases the risk of developing OA and fastens disease progression. This study~     will evaluate two different programs, lifestyle behavioral weight management and pain-coping~     skills training, in reducing the effects of knee OA in obese individuals.~   "
248073|NCT00305877|"~     This randomized phase II trial is studying bevacizumab to see how well it works compared to~     cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in~     treating patients with pancreatic cancer that has been completely removed by surgery.~     Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Radiation~     therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together~     with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells~     that remain after surgery. It is not yet known whether bevacizumab is more effective than~     cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in~     treating pancreatic cancer.~   "
248074|NCT00305864|"~     This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when~     given together with temozolomide and radiation therapy and to see how well they work in~     treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma.~     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Motexafin~     gadolinium may help temozolomide work better by making tumor cells more sensitive to the~     drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Motexafin gadolinium may~     also make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium~     together with temozolomide and radition therapy may kill more tumor cells.~   "
248075|NCT00305851|"~     RATIONALE: Music therapy or book discussion may improve quality of life in patients~     undergoing stem cell transplant. It is not yet known whether music therapy is more effective~     than book discussion in improving quality of life in patients undergoing stem cell~     transplant.~      PURPOSE: This randomized phase III trial is studying how well music therapy works compared to~     listening and discussing books on tape in improving quality of life in young patients~     undergoing stem cell transplant.~   "
248076|NCT00305838|"~     RATIONALE: Estrogen may cause the growth of ovarian cancer cells. Hormone therapy using~     tamoxifen may fight ovarian cancer by blocking the use of estrogen by the tumor cells.~     Measuring CA 125 levels may help doctors predict a patient's response to tamoxifen and help~     plan the best treatment.~      PURPOSE: This phase II trial is studying CA 125 levels in treating patients with relapsed~     advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are~     receiving tamoxifen.~   "
248077|NCT00305825|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others~     interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Estrogen can cause the growth of~     breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the~     amount of estrogen the body makes. Giving bevacizumab together with letrozole may be an~     effective treatment for locally advanced or metastatic breast cancer.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with letrozole~     works in treating postmenopausal women with locally advanced or metastatic breast cancer that~     cannot be removed by surgery.~   "
248078|NCT00305812|"~     RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the~     cancer. It may also stimulate the immune system in different ways and stop cancer cells from~     growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     lenalidomide together with melphalan may kill more cancer cells.~      PURPOSE: This randomized phase II trial is studying the side effects and best dose of~     lenalidomide when given together with melphalan and to see how well they work in treating~     patients with multiple myeloma.~   "
248079|NCT00305799|"~     RATIONALE: Understanding how oxaliplatin affects hearing loss, dizziness, and peripheral~     neuropathy may improve the ability to plan effective treatment for patients receiving~     oxaliplatin for solid tumors.~      PURPOSE: This clinical trial is studying hearing loss and dizziness in patients receiving~     oxaliplatin for solid tumors.~   "
248080|NCT00305786|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     oxaliplatin works as second-line therapy in treating patients with stage III or stage IV~     non-small cell lung cancer.~   "
248081|NCT00305773|"~     Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for~     their growth. Giving the drug in different ways may kill more cancer cells. This randomized~     phase II trial is studying two different schedules of vorinostat to see how well they work in~     treating patients with acute myeloid leukemia.~   "
248108|NCT00305409|"~     The purpose of this study is to determine whether administration of a synbiotic, comprised on~     inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha~     and other pro-inflammatory cytokines in the mucosa of Crohn's patients with active disease to~     reduce mucosal inflammation and induce remission.~   "
248109|NCT00305396|"~     A prospective, single center, open-label, randomized trial of Thymoglobulin induction and~     sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and~     tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased~     donor kidney transplant recipients.~   "
248082|NCT00305760|"~     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune~     response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well vaccine therapy works when given together~     with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced~     pancreatic cancer.~   "
248083|NCT00305747|"~     RATIONALE: Diindolylmethane may slow the growth of prostate cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in~     treating patients with nonmetastatic prostate cancer that has not responded to previous~     hormone therapy.~   "
248084|NCT00305734|"~     This phase II trial is studying how well giving bortezomib together with gemcitabine works in~     treating patients with recurrent or metastatic nasopharyngeal cancer. Bortezomib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving bortezomib together~     with gemcitabine may kill more tumor cells~   "
248085|NCT00305708|"~     RATIONALE: Drugs used in chemotherapy, such as busulfan and fludarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. A~     donor peripheral blood, bone marrow , or umbilical cord blood transplant may be able to~     replace blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted~     cells from a donor can make an immune response against the body's normal cells. Giving~     antithymocyte globulin before the transplant may stop this from happening.~      PURPOSE: This phase I/II trial is studying the side effects of busulfan, antithymocyte~     globulin, and fludarabine when given together with a donor stem cell transplant in treating~     young patients with blood disorders, bone marrow disorders, chronic myelogenous leukemia in~     first chronic phase, or acute myeloid leukemia in first remission.~   "
248086|NCT00305695|"~     This randomized phase II trial is studying zoledronate to see how well it works compared to~     observation in maintaining bone mineral density in patients who are undergoing surgery to~     remove both ovaries. Zoledronate may prevent bone loss in patients who are undergoing surgery~     to remove the ovaries.~   "
248087|NCT00305682|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. An~     umbilical cord blood transplant may be able to replace blood-forming cells that were~     destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a~     donor can make an immune response against the body's normal cells. Giving sirolimus and~     mycophenolate mofetil after the transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide~     together with total-body irradiation followed by an umbilical cord blood transplant,~     sirolimus, and mycophenolate mofetil works in treating patients with hematologic cancer.~   "
248088|NCT00305669|"~     RATIONALE: Colony-stimulating factors, such as GM-CSF, may help the body build an effective~     immune response to kill tumor cells. Giving GM-CSF before surgery may be an effective~     treatment for localized prostate cancer.~      PURPOSE: This clinical trial is studying how well giving GM-CSF before surgery works in~     treating patients with localized prostate cancer.~   "
248089|NCT00305656|"~     This phase II trial is studying how well AZD2171 works in treating patients with recurrent~     glioblastoma multiforme. AZD2171 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor~   "
248090|NCT00305643|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving radiation therapy~     together with capecitabine may kill more tumor cells. Celecoxib may prevent or lessen~     hand-foot syndrome caused by capecitabine.~      PURPOSE: This randomized phase III trial is studying how well celecoxib works in preventing~     hand/foot syndrome caused by capecitabine in patients with metastatic breast or colorectal~     cancer.~   "
248091|NCT00305630|"~     Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to~     photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration~     (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection~     with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed~     for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months~     on fluorescein angiography.~   "
248092|NCT00305617|"~     RATIONALE: Determining whether erlotinib passes into the cerebrospinal fluid may help in~     planning treatment for some types of cancer.~      PURPOSE: This clinical trial is studying how well erlotinib is able to pass into the~     cerebrospinal fluid of patients receiving erlotinib for stage III non-small cell lung cancer.~   "
248093|NCT00305604|"~     To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients~     with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.~   "
248110|NCT00305383|"~     The purpose of this study is to examine the rapid virologic response (RVR) at combination~     therapy (CT) Week 4 between groups receiving a standard combination peginterferon~     alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine~     monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.~   "
248165|NCT00304642|"~     Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase~     I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of~     dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy~     HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive~     2.5mL dapivirine vaginal microbicide gel at one of three concentrations.~   "
248094|NCT00305591|"~     Hepatic encephalopathy (HE) is a frequent complication of chronic liver disease (cirrhosis)~     and involves a wide spectrum of problems from mild impairment of reaction times in driving~     and operating machinery through to disturbances in mood, behaviour and conscious levels.~      Magnetic resonance imaging (MRI) is a method of obtaining pictures of the inside of the body.~     Patients with liver disease have previously been studied with MRI which has highlighted~     changes in the brain. This research aims to highlight some of the differences in the way that~     the brain functions in patients with liver disease. Using our new, more powerful MRI scanner,~     with more sophisticated techniques we hope that the novel combination of MRI techniques can~     objectively detect the presence of , and monitor HE.~      Study hypothesis: Hepatic encephalopathy (HE) is a reversible, metabolic disturbance of the~     brain, associated with low grade brain swelling and disturbances of the chemical balance~     within the brain, resulting in functional impairment, the presence of which MR imaging can~     detect with sufficient sensitivity to monitor the changes that may occur over time in~     response to treatment.~   "
248095|NCT00305578|"~     The purpose of this study is to investigate whether addition of memantine to bipolar~     depression patients who have had an incomplete response to lamotrigine (Lamictal) which is~     frequently used to treat bipolar depression in the clinical setting. At present, memantine is~     approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the~     treatment of bipolar depression. Subjects will be asked to participate because they are~     suffering from bipolar depression associated and have had an inadequate response to~     lamotrigine. Subjects will have to be on at least 100 mg per day, for at least 4 weeks.~   "
248096|NCT00305565|"~     This is a postmarket medical device study. The objective of this study is to compare the~     safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different~     amounts of electrical charge for the treatment of patients with treatment-resistant~     depression (TRD).~   "
248097|NCT00305552|"~     Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph~     nodes and the skin. Skin lesions may be disfiguring and impair the quality of life.~     Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis~     in case reports. The objective is to assess the efficacy and tolerance of thalidomide in skin~     sarcoidosis.~   "
248098|NCT00305539|"~     Hypothesis: In giant cell arteritis (GCA), a short initial treatment with anti-TNF may allow~     a faster decrease of steroids dosage and therefore avoid some of the adverse events of~     steroids.~   "
248099|NCT00305526|"~     This protocol will evaluate the effect of cardiac resynchronization therapy (CRT) combined~     with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker~     therapy was either not tolerated or could not be up titrated to optimal doses before CRT.~     Cardiac resynchronization therapy will be combined with automatic implantable cardioverter~     defibrillator (AICD, CRT-D) as it has been shown to be associated with an improvement in~     prognosis in the patients with left ventricular systolic dysfunction and heart failure.~   "
248100|NCT00305513|"~     Unilateral spatial neglect (USN) is believed to be a disorder of attention, characterized by~     impairment in the ability to perceive or respond to stimuli presented to the contralesional~     space, and which is not attributable to significant sensory or motor deficits. USN has~     serious consequences for rehabilitation and long term disabilities. Efforts have been made to~     clarify both the theoretical basis of this phenomenon and the rehabilitation methods that~     will be best in improving function. The purpose of this study is to try and contribute to~     both efforts by examining treatment effectiveness of two methods; one targeting general~     arousal (phasic alerting), and the other targeting increasing awareness to left side stimuli~     and habit changes. Functional neuroimaging methods (PET [positron emission tomography] and~     fMRI [functional magnetic resonance imaging]) have been applied to understand the functional~     anatomy of the brain during mental processes. Only a few attempts have been made to use~     functional neuroimaging in patients with neurological deficits such as USN, usually~     speculations are made based on findings with healthy participants to explain this disorder.~     This study's aim is to examine the functional reorganization of the attentional network in~     the brain of USN patients while performing visual tasks, by means of functional neuroimaging~     techniques, in light of specific rehabilitation techniques.~      Patients will be examined before and after 3 weeks of rehabilitation both using standardized~     neurobehavioral tests and PET imaging procedures.~   "
248101|NCT00305500|"~     Objectives: To evaluate tolerability and efficacy of escitalopram treatment in high dose than~     20-50 mg/d in out-patients with OCD Type of the study: Open label, prospective study.~      Number of patients: 100 patients with OCD~      Duration of the study: 18-weeks of active treatment, 8-visits:~      Dose titration:~      One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment– if partial/no response,~     according to YBOCS score and clinical judgment, dose increase of up to 50mg depending on~     response, adverse events, patient preference and judgment of the clinician 12 weeks follow up~     on high dose. Total of 18 weeks of follow-up.~   "
248102|NCT00305487|"~     The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in~     children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at~     two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a~     treatment period (2 weeks).~   "
248103|NCT00305474|"~     This study seeks to determine whether adult, non-psychotic, first-degree relatives of~     schizophrenic patients who show specific neurocognitive deficits and negative symptoms will~     show improvements in these areas following a 6-month, double-blind trial of a low dose (up to~     2.0 mg) of risperidone.~   "
248104|NCT00305461|"~     The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary~     function and time to first exacerbation in patients with moderate persistent asthma.~     Ciclesonide will be administered once daily in the evening at two dose levels. The study~     duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).~   "
248105|NCT00305448|"~     This study will assess the relationship between fulvestrant dose and efficacy, and determine~     the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen~     receptor positive advanced breast cancer.~   "
248106|NCT00305435|"~     The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured~     by platelet counts by cohort dose-escalation design.~   "
248107|NCT00305422|"~     The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic~     patients during therapy with quetiapine or risperidone.~   "
248111|NCT00305370|"~     There is a scarcity of clinical trials assessing the effects of medications in children with~     bipolar disorder. This study aims to assess the efficacy of Aripiprazole associated with~     Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder~     comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not~     have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double~     blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole~     + placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores~     compared to aripiprazole + placebo.~   "
248112|NCT00305357|"~     Evolution of pain and neural injury will be evaluated at 2 years or longer after the onset of~     AHZ by multiple measures. Assessments at 2 years or longer will be compared to those~     collected during the first 6 months after HZ in order to test whether or not sensory function~     and cutaneous innervation continues to normalize beyond 6 months in subjects who recover from~     HZ without severe PHN.~   "
248113|NCT00305344|"~     While this study is now completely enrolled, we do hope to develop a next generation cord~     blood based study sometime in early 2009. Please continue to contact us if you have a child~     with newly diagnosed Type 1 Diabetes (T1D) who alo has their OWN cord blood in storage.~   "
248114|NCT00305331|"~     The dopamine agonists, pramipexole (Mirapex) and ropinirole (Requip), are drugs that are used~     to treat symptoms of Parkinson's disease. However, these drugs can induce bothersome leg~     swelling or edema in about 20 percent of patients. The cause of this edema is unknown but may~     be secondary to stimulation of peripheral dopamine receptors in the kidney or blood vessels.~     We hypothesise that a peripherally acting dopamine receptor antagonist, will reduce edema in~     PD patients. This study will assess the effect of the peripheral acting dopamine D2 receptor~     antagonist, domperidone as a potential treatment for dopamine agonist-induced leg swelling.~   "
248115|NCT00305305|"~     Dr. Elliott Sherr and his collaborators at University of California, San Francisco (UCSF) are~     studying the genetic causes of disorders of cognition and epilepsy, in particular disorders~     of brain development that affect the corpus callosum, such as Aicardi syndrome, as well as~     two additional brain malformations, polymicrogyria and Dandy-Walker malformation. The goal of~     the investigators' research is to use a better understanding of the underlying genetic causes~     as a foundation to develop better treatments for these groups of patients.~   "
248116|NCT00305292|"~     The UCSF Pain Clinical Research Center (PCRC) is conducting a study of the effects of~     modafinil (Provigil®; Vigiver, Alertec), alcohol and the combination on alertness, mood,~     visual motor and cognitive performance, and pain sensation. Modafinil is a stimulant drug~     marketed as a wakefulness and alertness promoting medication.~   "
248117|NCT00305279|"~     The purpose of this study is to determine the effects of different amounts of phosphorus in~     the diet on hormones that control phosphorus and bone health both in people who are healthy~     and in ones who have moderate kidney disease.~   "
248118|NCT00305266|"~     The aim of this study is to quantify the effect of IVIG treatment in a group of patients with~     chronic inflammatory demyelinating polyradiculoneuropathy(CIDP), who requires continues~     treatment of IVIG at regular intervals of 3-10 weeks:~        1. During continues treatment of IVIG at regular intervals of 3-10 weeks.~        2. During pause in treatment.~      Hypothesis:~        1. The disease activity in the patients are cyclical correlating to the treatment~          intervals.~        2. Pause in treatment will increase disease activity, which can be quantified with symptom~          scores, disability scales, and clinical test.~      Primary effect parameter is muscle strength quantified by isokinetic dynamometry.~      Added to the protocol there is an immunological study of inflammatory markers in blood~     samples of patients under treatment pause.~   "
248119|NCT00305253|"~     This study will test the efficacy of the NASG on women suffering from obstetric hemorrhage as~     compared to hemorrhaging women who do not receive the NASG.~   "
248120|NCT00305240|"~     The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA)~     testing of patients that have had a heart attack and have decreased pumping ability of the~     lower chamber of their heart. MTWA testing is a non-invasive test used to detect the~     likelihood of developing abnormally fast rhythms in the lower chambers of the heart. The~     objective of the study is to prove that if a patient has a negative MTWA test, they will be~     less likely to develop abnormally fast and dangerous rhythms in the lower chambers of the~     heart. The results of the study will help doctors to determine which patients would benefit~     the most from having an Implantable Cardioverter Defibrillator (ICD) implanted.~   "
248121|NCT00305227|"~     Recurrent urinary tract infections (RUTIS) continue to be a major health problem in women and~     are now complicated by increasing antibiotic resistance. New preventive approaches are~     needed. Because most women with RUTI lack the normal protective Lactobacillus (LB) in their~     vaginal flora, we hypothesized that restoration of LB would reduce RUTIS. In this trail,~     women with recent UTI are randomized to receive either LB or placebo vaginal capsules and are~     followed for side effects, for colonization with LB and for occurrence of RUTI over hte next~     four months.~   "
248122|NCT00305214|"~     The purpose of the study is to determine the usefulness of Microvolt T Wave Alternans (MTWA)~     testing of patients that have had a heart attack and have decreased pumping ability of the~     lower chamber of their heart. MTWA testing is a non-invasive test used to detect the~     likelihood of developing abnormally fast rhythms in the lower chambers of the heart. The~     objective of the study is to prove that if a patient has a positive MTWA test, they will be~     more likely to develop abnormally fast and dangerous rhythms in the lower chambers of the~     heart. The results of the study will help doctors to determine which patients would benefit~     the most from having an Implantable Cardioverter Defibrillator (ICD) implanted.~   "
248123|NCT00305201|"~     The purpose of this study is to determine whether Chilean children with history of Kawasaki~     disease have endothelial dysfunction years after the acute phase of the disease, and if this~     condition can be modified by treatment with statins.~   "
248160|NCT00304707|"~     Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment~     for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate~     the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving~     treatment for alcohol dependence.~   "
248455|NCT00300690|"~     This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE)~     performs better than Dacron for above knee femoropopliteal bypass.~   "
248124|NCT00305188|"~     Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory~     neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and~     placebo group.~      Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo~     group in order to ensure that the efficacy of the chemotherapy is not compromised by the~     addition of xaliproden to the chemotherapeutic regimen.~      Other Secondary Objectives : study of the neurotoxicity parameters (Duration of~     oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of~     PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin~     treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of~     the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free~     survival, overall survival).~   "
248125|NCT00305175|"~     The primary objectives of this prospective, observational study are (1) to describe the~     long-term cellular, molecular, and clinical effects of hydroxyurea therapy in sickle cell~     disease, and (2) to perform hydroxyurea pharmacokinetics studies.~      This study will follow sickle cell patients being treated with hydroxyurea for a long period~     of time to evaluate the long-term cellular and molecular effects of the drug on the patients'~     body. This study will consist of two patient groups. One group will be made up of patients~     who have received hydroxyurea therapy before entering the study. The second group will be~     made up of patients who have not received hydroxyurea before study entry.~   "
248126|NCT00305162|"~     The primary objective of this study is to demonstrate that the efficacy of cangrelor is~     superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.~   "
248127|NCT00305149|"~     .This study is trying to address change of chemotherapy dosage according to individual~     patient response to initial cycles of chemotherapy in order to reduce cumulative dose of~     chemotherapy.The study includes patients with early unfavorable and advanced hodgkin~     lymphoma. Patients with low risk were started with standard beacopp and only high risk~     patients were started with escalated beacopp.Following 2 cycles of therapy the patients were~     reassessed.Based on scintigraphy results decision was made regarding further therapylative~     chemotherapy for early responders and maximize dose intensity for late responders.~   "
248128|NCT00305136|"~     Recent advances in the field of pain psychophysics that have enhanced the understanding of~     pain processing by the nervous system seem to characterize the individual pattern of pain~     processing, thereby enabling the prediction of a person's susceptibility to develop chronic~     pain consequent to surgery.~      In this project, the researchers propose to apply a wide array of advanced testing methods in~     order to prospectively assess the pain modulation pattern of pain free patients about to~     undergo an elective thoracotomy. Since about half of post-thoracotomy patients suffer from~     chronic neuropathic postoperative pain, the researchers expect to identify which tests~     predict a risk for this pain and the relative power of the relevant tests in this prediction,~     and to construct a short and applicable tool, the 'pain susceptibility profile', that will~     reliably predict the risk for the development of pain. The expected results of this project~     will serve the field of pain prevention by identifying patients at risk and tailoring~     interventions to reduce the risk of chronic pain.~   "
248129|NCT00305123|"~     The purpose of this study is to learn more about sore throats caused by the germ Group A~     Streptococcus (GAS) or Strep. When Strep causes a sore throat, it can be treated with~     medicines called antibiotics. However, if not treated, it can lead to heart problems and~     other serious diseases. This study will identify the different types of Strep that are~     present in children with sore throats. Researchers will check children with sore throats at~     least twice weekly among a group of approximately 12,000 children. Study participants will~     include children, ages 5-16, attending the public elementary schools in Djikoroni-Sébénikoro,~     a low income community in Bamako, Mali. Throat swabs will be obtained and free treatment is~     available when a child enrolled in the group complains of a sore throat. The information from~     this study may help make a vaccine to prevent Strep infection in Malian children. Children~     may participate for the 3 year duration of the study.~   "
248130|NCT00305110|"~     The purpose of this study is to determine the safety and speed of onset of 2mg intravenous~     hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency~     department with acute severe pain~   "
248131|NCT00305097|"~     Habitual consumption of coffee may have substantial beneficial effects on glucose metabolism~     according to recent findings of epidemiological studies in the U.S., Europe, and Japan.~     However, data from longer-term human intervention studies with appropriate outcome measures~     are lacking. We will study the effects of caffeinated and decaffeinated coffee consumption on~     body fatness, insulin sensitivity and glucose tolerance that may underlie the observed~     associations with a lower risk of type 2 diabetes in a randomized controlled trial. We~     hypothesize that both caffeinated and decaffeinated coffee will improve insulin sensitivity~     and glucose tolerance. Before starting a larger, long-term intervention study, we will~     conduct a pilot study to test the feasibility of such a trial. The pilot study will be an~     8-week parallel trial in 45 overweight individuals, who will be randomized to drinking 5 cups~     per day of 1) caffeinated coffee (n=15), 2) decaffeinated coffee (n=15), or 3) water (n=15).~     Body fatness (weight, waist circumference, bioelectrical impedance), insulin sensitivity~     (HOMA model), and glucose tolerance (oral glucose tolerance test) will be the primary~     outcomes. We will assess the adherence of participants to their assigned treatment by~     measuring serum caffeine concentrations, documentation of coffee use in diaries by the~     participants, and counting unused coffee packets. We will also obtain feedback from~     participants on how to improve compliance in a future trial. If successful, this study will~     form the basis for a definitive trial of coffee consumption, body fatness, and glucose~     tolerance. Given the extensive use of coffee and the rapidly increasing health burden of type~     2 diabetes, such a trial would have important public health implications.~   "
248132|NCT00305084|"~     The main objective of the trial is to document the safety of the combination (escalation~     doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of doxorubicin, 75~     mg/sqm). Safety will be established by clinical and laboratory assessment according to~     National Cancer Institute Common Toxicity Criteria (NCI-CTC ).~   "
248183|NCT00304395|"~     The purpose of this research is to identify cases from patients who have been referred for~     consultation to the Infectious Disease Section at the VAMC, Houston, and to compare them with~     other cases of CAP in order to determine whether there are features that might enable non-CAP~     cases to be distinguished from CAP.~   "
248133|NCT00305071|"~     In conventional treatment for non-complicated bacterial cystitis, 3-day oral antibiotics~     could achieve good cure rate. However, severe lower urinary tract symptoms were most~     bothersome and only could be partially relieved by NSAID, detrusor muscle relaxants, minor~     tranquilizer or pyridium. Some medication associated side effects were complained while~     receiving adjuvant medication treatment, including gastro-intestinal discomfort, dry mouth,~     blurred vision, lethargy, or allergic reactions. The irritative bladder symptoms from bladder~     inflammation had great impact on the quality of life and well tolerable adjuvant therapy~     would have clinical benefit to reduce the discomfort from the bladder.~      In the past years, cranberry juice or its extract has been proven to have protective effect~     on urothelium to prevent further bacterial ascending infection. The commercial cranberry~     extract tablets have good tolerability and showed good effect on symptoms reliving and~     infection protection on several clinical observation. In acute bladder infection, we could~     expect the bioactive components in cranberry could reduce the virulence of pathogens and~     assist to eradicate pathogens and to stable the urothelium. In literature review, only little~     works focusing on the symptoms relief in acute cystitis patients. To clarify the clinical~     benefit on lower urinary symptoms relieving, we attempt to conduct a randomized double-blind~     placebo-controlled trial to evaluate the effect of a compound cranberry extract tablet as an~     adjunctive modality in treating acute uncomplicated bacterial cystitis in otherwise healthy~     female patients.~   "
248134|NCT00305058|"~     The purpose of this research study is to determine which opiate pain medication (morphine or~     hydromorphone (Dilaudid)) is more effective in the treatment of acute pain in patients~     presenting to the emergency department.~   "
248135|NCT00305045|"~     Studies exploring the efficacy of repetitive transcranial magnetic stimulation (rTMS) as a~     treatment for refractory major depressive disorder (MDD) have shown significant promise.~     Despite this, several questions regarding the treatment parameters needed to optimize~     efficacy remain. Moreover, there is also a lack of clear understanding as to the therapeutic~     mechanisms involved. For example, several lines of evidence suggest that patients with MDD~     have deficits in cortical inhibition (CI) and that these deficits are key to understanding~     the pathophysiology of this disorder. With this study, we seek to confirm the therapeutic~     potential of an acute course of rTMS for treatment-refractory MDD in a large sample of~     patients. In addition, we will strive to clarify the neurophysiological mechanisms through~     which rTMS exerts its therapeutic effects, using both TMS and electroencephalography/event~     related brain potential (EEG/ERP) measures of neurophysiological activity. Moreover, in this~     study, we intend to investigate the efficacy of a maintenance course of rTMS in an effort to~     prevent symptom recurrence.~   "
248136|NCT00305032|"~     To investigate the effect of weight loss by gastric balloon insertion on parameters of~     obstructive sleep apnea.~   "
248137|NCT00305019|"~     The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg~     once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (HBV).~   "
248138|NCT00305006|"~     A randomized control trial of constraint-induced movement therapy and bimanual training. The~     protocols have been developed at Columbia University to be child friendly and draws upon our~     experience since 1998 with constraint-induced movement therapy in children with cerebral~     palsy.~   "
248139|NCT00304993|"~     Lipid abnormalities in people with the Metabolic Syndrome (the Insulin Resistance Syndrome)~     are characterized by elevations in triglycerides and LDL cholesterol; low levels of HDL~     cholesterol; and small, dense LDL particles. Statins generally do not change LDL particle~     size, so often fenofibrate is added. This combination may still not be sufficient. Niacin is~     a common third drug added to the treatment regimen, but niacin can increase insulin~     resistance. This study compares niacin as a third drug to rosiglitazone, an insulin~     sensitizer.~   "
248140|NCT00304980|"~     The purpose of this study is to determine the safety and efficacy of~     sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to~     HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised~     to one of the 2 treatment and followed up (until day 14 actively) for 45 days.~   "
248141|NCT00304967|"~     This study will use a method called dynamic light scattering (DLS) to study the lens of the~     eye in young normal subjects. The DLS device uses a very dim laser light to study the lens of~     the eye. It detects proteins in the lens, identifying early changes that may make the device~     useful in future cataract studies. This study will use DLS to examine the characteristics of~     proteins in healthy young lenses that can be used for comparison with lenses in older people~     and people with cataracts.~      Normal volunteers aged 5 to 21 years may be eligible for this study. Participants undergo the~     following procedures:~      Medical history~      Eye examination with dilation to include:~        -  Measurement of visual acuity~        -  Examination of pupils and eye movements~        -  Examination of the front of the eye (cornea, lens) with a slit lamp bio-microscope~        -  Examination of retina with an ophthalmoscope (instrument with a strong light and~          magnifying lens)~        -  Dynamic light scattering~   "
248142|NCT00304954|"~     This study examined whether the anti-inflammatory medicines infliximab, sirolimus or~     daclizumab, when given with a participant's current therapies, would prevent the growth of~     new blood vessels in the eye in participants with age-related macular degeneration (AMD).~      Participants 55 years of age and older with AMD and drusen larger than 63um may be eligible~     for this study. Vision in the study eye was between 20/20 and 20/400.~      Participants were randomly assigned to one of three treatments - infliximab, sirolimus, or~     daclizumab - or to observation only. In addition, participants may have been treated by their~     ophthalmologist as needed for their AMD.~      Infliximab and daclizumab were given intravenously (through a vein); infusions were given at~     enrollment in the study, then at 2 weeks, and then monthly.~      Sirolimus was a pill that was taken every other day for the duration of the study. At 6~     months, participants were evaluated to see whether continuing treatment would be beneficial.~      In addition to treatment or observation, participants underwent the following procedures:~      Physical examination at enrollment and 6 months.~      Photographs of the back of the eye, fluorescein angiography, indocyanine green angiography~     and measurement of retinal thickness at enrollment and months 1, 3 and 6.~        -  Fluorescein angiography evaluated the eye's blood vessels. A yellow dye was injected~          into an arm vein and traveled to the blood vessels in the eyes. Pictures of the retina~          were taken using a camera that flashed a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating possible blood vessel~          abnormality.~        -  Indocyanine green angiography identified feeder vessels that may have supplied abnormal~          blood vessels. This procedure is similar to fluorescein angiography, but uses a green~          dye and flashes an invisible light.~        -  Optical coherence tomography measures retinal thickness. This test shines a light into~          the eye and produces cross-sectional pictures of the retina. These measurements are~          repeated during the study to determine whether retinal thickening is getting better or~          worse, or staying the same.~      Tuberculin skin test and chest x-ray at enrollment and 6 months.~      Blood tests at enrollment and months 1, 3 and 6.~   "
248456|NCT00300677|"~     To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance~     doses over 3 days and compare it to the amount of voriconazole in the plasma.~   "
248143|NCT00304941|"~     This study will characterize risk factors associated with breast cancer development in some~     patients. In particular, it will examine the role of insulin in breast cancer in patients~     with and without a family history of the disease.~      Women 30 to 70 years old who have been diagnosed with breast cancer and matched control~     healthy subjects with and without a family history of breast cancer may be eligible for this~     study.~      Participants undergo the following procedures:~        -  Cancer-genetic counseling session, including family history, risk assessment, genetic~          testing for BRCA1 and BRCA2 (if criteria is met), interpretation of results and~          management options~        -  Medical history, including questions about symptoms or diseases, reproductive history,~          use of oral contraceptives, body weight, exercise, lifestyle, and demographic issues~        -  Drawing of family tree~        -  Examination of medical records~        -  Blood drawing for genetic and other tests~        -  CT scan of the abdomen (approximate time < 1 minute)~        -  Filling out questionnaires~   "
248144|NCT00304915|"~     This study is a randomized trial designed to test and refine a collaborative care model for~     treating depression in VA patients with HIV.~   "
248145|NCT00304902|"~     The purpose of this study is to review medical records at MEDVAMC in order to relate the~     outcome of bacteremic MRSA infection to the antibiotics selected for treatment.~   "
248146|NCT00304889|"~     The purpose of this study is to compare the outcome of treatment with nitazoxanide vs.~     vancomycin for diarrheal disease due to Clostridium difficile in patients who have failed~     previous treatment with metronidazole.~   "
248147|NCT00304876|"~     The investigators propose to study intensively the bacteriology of feces in C. difficile~     associated diarrheal disease, using a variety of conventional and very up-to-date techniques.~   "
248148|NCT00304863|"~     The purpose of this study is to determine whether dietary supplementation with Lactobacillus~     GG will reduce the rate of failure or relapse following treatment of CDAD with metronidazole.~   "
248149|NCT00304850|"~     After surgery, sensitization and hyperexcitability of central nervous system result in acute~     and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA)~     receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate~     analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential~     components of cells functioning and are also known as allosteric modulators of NMDA~     receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive~     properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free~     diet in women operated on breast cancer versus kétamine~   "
248150|NCT00304837|"~     The purpose of this gene therapy study is to evaluate the safety and efficacy of~     intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in~     patients with moderate to high-risk Critical Limb Ischemia (a condition in which there is~     poor blood circulation in the leg). This trial will assess whether VEGF improves rest pain~     and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg~     arteries.)~      VEGF is DNA, or genetic material that will be injected into the leg muscles on three separate~     occasions, each 2 weeks apart. Once the DNA is in the leg, it directs the cells of the artery~     wall to increase its production of VEGF, which has been shown to cause new blood vessels to~     grow. This experimental therapy is designed to grow new blood vessels around blockages in the~     leg arteries.~      The total length of participation in this study is approximately 1 year and will require~     approximately 8 clinic visits within that year. Following enrollment in the study, testing~     may be done for cancer screening, blood work, physical exams, vascular testing and eye exams.~     There is no charge for any testing or office visits required by the study.~      This study has been approved by the Food and Drug Administration (FDA).~   "
248151|NCT00304824|"~     Glaucoma is one of the leading causes of blindness worldwide. The key feature of glaucoma is~     damage to the optic nerve head with loss of retinal ganglion cells and local tissue~     remodeling. Neuronal cell death in glaucoma occurs by apoptotic mechanisms1. Apoptosis of~     neurons also plays a major role in neurodegenerative diseases, such as Alzheimer's or~     Parkinson's disease. An association between glaucoma and these disorders has been described~     2-4. Furthermore, it has been reported that the olfactory function is disturbed in these~     neurodegenerative diseases5-6. We hypothesize that similar olfactory alterations may occur in~     glaucoma which is in fact a local neurodegenerative disease.~   "
248152|NCT00304811|"~     The purpose of this study is to compare the outcome of treatment for bacteremic MRSA~     infection with vancomycin alone, vancomycin plus gentamicin, vancomycin plus rifampin, and~     vancomycin plus gentamicin and rifampin.~   "
248153|NCT00304798|"~     Evaluate for difference in outcome between hospital admission versus discharge after recent~     TIA, and evaluate feasibility of a larger study.~   "
248154|NCT00304785|"~     To compare the intraocular pressure effect and safety of latanoprost 0.005% given every~     evening versus PTFC given twice daily.~   "
248155|NCT00304772|"~     The purpose of this study is to verify the equivalence in clinical efficacy of fluconazole~     and micafungin for the treatment of Candida bloodstream infection in non-neutropenic~     patients.~   "
248156|NCT00304759|"~     This trial is designed to determine whether an 8-week course of escalated dose conformal~     radiation can be compressed safely, and with similar efficacy into a 4-week course.~   "
248157|NCT00304746|"~     We hypothesize that AndroGel may offer some relief to subjects with low or borderline~     testosterone levels who suffer from depression and have failed to respond to a trial of a~     standard antidepressant.~      During this nine week, outpatient, double-blind study, male subjects between the ages of 30~     and 65 years with treatment-refractory depression and low or borderline low testosterone~     levels will be treated with either AndroGel or placebo. Following this nine week,~     double-blind phase, eligible subjects will have the option to continue into a six month,~     open-label phase during which time all subjects will receive the AndroGel patch.~   "
248158|NCT00304733|"~     Objective: to compare the effectiveness of irremovable total contact casts and custom made~     temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes~   "
248159|NCT00304720|"~     Primary Objective:~      A. To determine whether stable allogeneic hematopoietic engraftment can be safely established~     in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with~     fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus~     and MMF.~      B. To evaluate the incidence of grade II-IV GVHD associated with this treatment.~   "
248166|NCT00304629|"~     The long-term safety and efficacy of galantamine (12 mg bid) will be documented during a one~     year open-label treatment in subjects with Alzheimer's Disease who completed the GAL-INT-8~     trial (up to 400 eligible patients). Safety will be tracked by means of adverse event~     reports, laboratory parameters and physical exam. Long-term efficacy will be evaluated by~     means of a Alzheimer's Disease Assessment Scale(ADAS) and activities of daily living scale~     Disability Assessment for Dementia Scale(DAD)~   "
248167|NCT00304616|"~     To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole~     administration~   "
248168|NCT00304603|"~     The purpose of this study is to explore the mode of action of topiramate in the treatment of~     obese and diabetic patients by testing association between genetic variations within~     candidate genes or chromosomes (thread like structure found in cell which carries genes) and~     the clinical outcomes.~   "
248169|NCT00304590|"~     This clinical study is being conducted at multiple sites to determine the activity, safety,~     and tolerability of XL999 when given weekly to patients with relapsed or refractory multiple~     myeloma. XL999 is a small molecule inhibitor of cellular factors including VEGFR, PDGFR, and~     FGFR that may be involved in multiple myeloma.~   "
248170|NCT00304577|"~     Infantile esotropia is corrected in most cases by bilateral recession of the medial rectus~     muscles (BR) or by unilateral recession of the medial rectus muscle and resection of the~     lateral rectus muscle (RR). We compared the outcome of these techniques in a randomized~     prospective study.~   "
248171|NCT00304564|"~     Falls are the largest cause of death in the elderly and those in nursing homes have even a~     higher incidence of falling. The purpose of this study is to determine whether listening to~     the Music of Nolwenn Leroy daily is effective in fall prevention in those elderly patients~     who are residents in several Texas geriatric nursing home facilities. The music of Nolwenn~     Leroy has been shown to be effective in fall reduction in a different setting (Posturographic~     Changes and Fall Prevention associated with Music Therapy: The Nolwenn Effect (USA~     ClinicalTrials.gov Identifier: NCT00121693) )with results better than listening to Mozart of~     any other music. Another similar study (USA ClinicalTrials.gov Identifier:NCT00272272)is~     presently being conducted in a geriatric nursing home facility in Georgia. Dynamic~     posturographic measurments will be obtained from all residents and compared to normative age~     related data and utilized to measure stability changes in this study.~   "
248172|NCT00304551|"~     This study evaluated the clinical response of the efficacy and safety of the combination~     therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free~     group in CHC patients with compensated LC.~      Additionally, this study evaluated the dosage reactivity and the pharmacokinetic~     characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC~     patients with compensated LC.~   "
248173|NCT00304538|"~     The purpose of this study is to identify the safest dose of very low dose glucagon to prevent~     hypoglycemia in patients with Type I diabetes who use insulin pumps and to measure the the~     amount of glucagon in the blood and see how the body responds to the glucagon.~   "
248174|NCT00304525|"~     The purpose of this study is to determine the safety profile, pharmacokinetics,~     pharmacodynamics and maximum tolerated dose of RAF265 in patients with locally advanced and~     metastatic melanoma.~      Phase II portion of study (dose expansion) has been cancelled with Amendment 7 as of Dec~     2011.~   "
248175|NCT00304512|"~     The purpose of this study is to determine whether AT1001 (migalastat hydrochloride) is safe~     and effective in female patients with Fabry disease.~   "
248176|NCT00304499|"~     The purpose of this study is to compare the side-effect profile and efficacy of sustained~     release, OROS® and TTS, dosage forms of oxybutynin with immediate release (IR) oral~     oxybutynin and with placebo.~   "
248177|NCT00304473|"~     Assess the efficacy of a fast titration of quetiapine to the current titration approved by~     the regulatory authorities.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
248178|NCT00304460|"~     Background:~      -Although IL-2 can shrink tumors in about 20 percent of patients with metastatic kidney~     cancer and in 15 percent of patients with metastatic melanoma, it is not fully known how the~     drug works.~      Objectives:~      -To better understand how IL-2 causes tumors to shrink.~      Eligibility:~      -Patients 18 years of age or older with metastatic kidney cancer or metastatic melanoma~      Design:~        -  135 patients with melanoma and 110 patients with kidney cancer may be enrolled.~        -  Patients are hospitalized for about 7 days for each treatment. They receive IL-2~          intravenously (through a vein) over 15 minutes every 8 hours for up to 4 days or 12~          doses. This constitutes one treatment cycle.~        -  Research blood samples are collected daily during the first treatment cycle and for one~          or two days following the last dose.~        -  Patients may be asked to undergo leukapheresis, a procedure for collecting large~          quantities of white blood cells. This involves collecting blood through a needle in an~          arm vein. The blood is directed through a cell separator where the white cells are~          extracted. The rest of the blood (red cells, platelets, and plasma) is returned to the~          patient through the same needle or through a needle in the other arm.~        -  About 7-10 days after discharge from the hospital, patients return for a second~          treatment cycle but without research blood sampling.~        -  2 months after therapy, patients are evaluated with scans, and x-rays, and blood tests~          to evaluate the tumor and the effects of the treatment on immune cells.~        -  Patients whose tumors shrink or remain stable may continue treatment (without repeating~          the full set of research blood samples) as long as they benefit from the treatment and~          do not develop unacceptable side effects. Patients who continue treatment are evaluated~          every 2 months for 3 to 4 times and then every 3 to 6 months.~   "
248179|NCT00304447|"~     The purpose of this study is to evaluate the effect of corticosteroids on the frequency and~     severity of Mylotarg® infusion-related adverse events, to evaluate the effect of~     corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete~     response with incomplete platelet recovery (CRp) at one-month post treatment.~   "
248180|NCT00304434|"~     Objective 1: Determine the safety and toxicity profile of Tamiflu administered in combination~     with probenecid in healthy adults.Objective 2: Determine the pharmacokinetic profile of~     Tamiflu and probenecid in healthy adults.~   "
248181|NCT00304421|"~     The purpose of the study is to compare the effect of two different drugs, rabeprazole (20 mg)~     and pantoprazole (40 mg), and their effects on the amount of acid produced by your stomach on~     evening and at night after standard protein meal.~   "
248182|NCT00304408|"~     The purpose of this study is three fold: 1)To collect serum from patients with documented~     Clostridium difficile infection and test for the presence of antibody to C. difficile toxin~     at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To~     collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay~     random serum samples from the VA lab in order to determine the rate of antibody to C.~     difficile toxin in our patient population.~   "
248184|NCT00304382|"~     The purpose of this study is to determine whether there are differences in the level of~     antibody to capsular polysaccharides of S. pneumoniae or the physiological activity of such~     antibody after vaccinating patients who have recovered from pneumococcal pneumonia with~     pneumococcal polysaccharide vaccine (Pneumovax) or conjugate pneumococcal vaccine (Prevnar).~   "
248185|NCT00304369|"~     In this record review study, our objective is to determine the rates of cure, failure and~     relapse following treatment of C. difficile colitis with metronidazole.~   "
248186|NCT00304356|"~     The purpose of this study is for compassionate use of nitazoxanide in the treatment of~     diarrheal disease due to Clostridium difficile infection when the patient has failed previous~     treatment with metronidazole or vancomycin.~   "
248187|NCT00304330|"~     The information collected will provide insight in to the epidemiology of antibiotic~     resistance in a transplant compared to a non-transplant population. Data is needed regarding~     the date of admission, date of bloodstream infection and location of ward/ICU so trends in~     the emergence of resistance and antibiotic usage can be detected.~   "
248188|NCT00304317|"~     The purpose of this trial is to quantify the amount Celebrex, a specific cyclooxygenase-2~     (COX-2) inhibitor, when used for the management of acute renal colic for a ureteral stone~     will:~        -  reduce pain medication usage~        -  improve the percentage of spontaneous stone passage~        -  decrease the time to spontaneous passage, and~        -  shift the size distribution of stones passed towards larger sizes~   "
248189|NCT00304304|"~     From a previous community needs survey, we determined that asthma was a particular problem in~     our community-based research network of child care centers. This study will examine whether a~     moderate intervention can help these centers improve their asthma-friendly rating as per~     NHLBI guidelines. We will both center directors and parents to establish baseline data on~     child health and the asthma-friendliness of each center. We will use a wait-list control,~     with all centers eventually receiving the intervention.~   "
248190|NCT00304291|"~     Neuromyelitis optica (NMO) is a severe demyelinating disease that selectively involves the~     optic nerves and the spinal cord but usually spares the brain. NMO is considered to have a B~     cell induced pathogenesis. Mitoxantrone (MITO, Novantrone®), a synthetic anthracenedione~     approved for worsening relapsing-remitting multiple sclerosis (MS) and secondary progressive~     MS, has been shown to primarily suppress the humoral response. We conducted a prospective~     2-year study to evaluate the benefit of MITO in five relapsing NMO patients.~   "
248191|NCT00304278|"~     The purpose of this study is to determine the safety and effectiveness of treatment with~     Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with~     Head and Neck cancer~   "
248192|NCT00304265|"~     Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis~     vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine.~      To describe and characterize adverse events occurring after vaccination with REPEVAX®~     (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated~     poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular~     pertussis) vaccine among two groups: Group 1 - adolescents 10-14 years of age who~     participated in study 371-03/01 (and thus received a 5th dose of TRIPEDIA® vaccine) and Group~     2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell~     pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their~     2nd through 7th year of life.~   "
248193|NCT00304252|"~     The purpose of this study is to determine the safety and efficacy of interferon beta-1a in~     maintaining remission in patients with Crohn's disease.~   "
248194|NCT00304239|"~     The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with~     methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source~     Aktilite CL128, in treatment of patients with multiple actinic keratosis (sun-damaged skin)~     on the face and / or scalp.~   "
248195|NCT00304226|"~     The population for this current study will include stage 1 and stage 2 hypertensive patients~     who are newly diagnosed or didn't have treatment during the last 3 months and patients who~     are currently treated but uncontrolled on present monotherapy.~      The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a~     treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.~   "
248196|NCT00304213|"~     This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men~     age > 60 years. The goal is to assess the safety and efficacy of TRT in men age > 60 years.~   "
248197|NCT00304200|"~     This study is designed to evaluate the safety and appropriate dose of the combination of~     Temodar and Sutent as first-line therapy for patients with metastatic malignant melanoma~     (Phase 1). Once the safety and appropriate dose is determined, additional patients will be~     studied at that dose to determine if there is clinical benefit as determined by the primary~     end-point of progression-free survival (PFS) at 6 months and additional secondary endpoints~     (Phase II).~   "
248198|NCT00304187|"~     This study will determine the effectiveness of the antibiotic erythromycin in enhancing~     gastrointestinal function and decreasing the frequency of binge eating in people with bulimia~     nervosa.~   "
248199|NCT00304174|"~     This study will evaluate whether people with bulimia nervosa will binge eat in a structured~     laboratory setting and display behavioral patterns similar to those of individuals who are~     dependent on drugs.~   "
248200|NCT00304161|"~     This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression~     in people with Parkinson's disease.~   "
248210|NCT00303979|"~     The purpose of this study is to characterize current management of patients with either heart~     failure or prior myocardial infarction and left ventricular dysfunction and to assess the~     effect of education, specific clinical guidelines, reminder systems, comprehensive disease~     state management tools, benchmarked quality reports, and academic detailing on the use of~     evidence-based heart failure therapies in cardiology practices. This study is a quality~     improvement initiative that is being conducted through review of patient records.~   "
248211|NCT00303966|"~     Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the cancer. This phase II trial is studying how well~     sorafenib works in treating patients with relapsed chronic lymphocytic leukemia.~   "
248201|NCT00304148|"~     Insights into the cause of kidney failure have emerged from research, but less is known about~     the epidemiology of less severe forms of kidney disease known both as chronic kidney disease~     (CKD) or chronic renal insufficiency (CRI).~      The Chronic Renal Insufficiency Cohort (CRIC) Study was established to study the consequences~     of CKD with a particular focus on cardiovascular illness like myocardial infarction (heart~     attack) and stroke. The CRIC Study will identify high-risk subgroups of individuals with CRI,~     informing future treatment trials, and development of preventive therapies.~      CRIC is an observational study that to date, 3612 participants have been enrolled in the CRIC~     cohort. The goal for Phase III is to enroll 1500 new participants across all seven Clinical~     centers (214 new participants per center). Participants previously enrolled will be followed~     for an additional 5 years and newly recruited participants will be followed for up to an~     additional 5 years. Principles underlying the targeted composition of the cohort of new~     recruits are very similar as the Phase I recruits, however with some modifications as listed~     below in the eligibility summary.~      No study treatments or interventions will be given to participants in CRIC. Subjects will~     include a racially and ethnically diverse group of adults aged 45 to 79 years old with a~     broad spectrum of renal disease severity and proteinuria levels. Participants who are 65~     years or older will undergo additional testing to assess physical and cognitive function,~     social support, and quality of life.~   "
248202|NCT00304135|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and~     gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It~     is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is~     more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic~     biliary tract cancer.~      PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and~     radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in~     treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.~   "
248203|NCT00304096|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating~     patients with stage III or stage IV breast cancer.~   "
248204|NCT00304083|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and etoposide, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving combination chemotherapy with or without radiation therapy before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving~     combination chemotherapy after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     patients with stage III or stage IV malignant peripheral nerve sheath tumors.~   "
248205|NCT00304070|"~     This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or~     surgery works in treating young patients with stage I, stage II, stage III or stage IV~     adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain~     after surgery.~   "
248206|NCT00304031|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving radiation therapy~     together with temozolomide may kill more tumor cells. It is not yet known which schedule of~     temozolomide when given together with radiation therapy is more effective in treating~     glioblastoma or gliosarcoma.~      PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide~     to compare how well they work when given together with radiation therapy in treating patients~     with newly diagnosed glioblastoma or gliosarcoma.~   "
248207|NCT00304018|"~     RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and etoposide, before a donor~     umbilical cord blood stem cell transplant helps stop the growth of cancer cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving antithymocyte globulin before transplant and tacrolimus and prednisone after~     transplant may stop this from happening.~      PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works~     in treating patients with advanced hematologic cancer.~   "
248208|NCT00304005|"~     RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to~     see how well it works in treating patients with Richter syndrome or refractory or relapsed~     chronic lymphocytic leukemia or other lymphoproliferative disorders.~   "
248209|NCT00303992|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     irinotecan, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving trastuzumab together with irinotecan may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving trastuzumab together with irinotecan~     works in treating patients with HER2/neu positive metastatic breast cancer.~   "
248212|NCT00303953|"~     This phase II trial is studying how well PXD101 works in treating patients with relapsed or~     refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to~     the cancer.~   "
248213|NCT00303940|"~     RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as temozolomide and carboplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving talabostat together with temozolomide or carboplatin may~     kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of talabostat when~     given together with temozolomide or carboplatin in treating young patients with relapsed or~     refractory brain tumors or other solid tumors.~   "
248214|NCT00303927|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well capecitabine works as second-line therapy~     in treating patients with stage IV pancreatic cancer who have the thymidylate synthase gene.~   "
248215|NCT00303914|"~     RATIONALE: Questionnaires that assess symptoms caused by cancer and cancer therapy may help~     improve the ability to plan treatment for patients with invasive cancer to help them live~     longer and more comfortably.~      PURPOSE: This clinical trial is studying symptoms caused by cancer and cancer therapy in~     patients with invasive breast, lung, prostate, or colorectal cancer.~   "
248216|NCT00303901|"~     RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment~     for primary lung cancer or lung metastases that cannot be removed by surgery.~      PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with~     primary lung cancer or lung metastases that cannot be removed by surgery.~   "
248217|NCT00303888|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Phenoxodiol may help docetaxel work better by making tumor cells more sensitive to the drug.~      PURPOSE: This randomized phase I/II trial is studying the side effects of docetaxel when~     given together with either phenoxodiol or placebo and to see how well it works in treating~     patients with recurrent advanced ovarian epithelial cancer, fallopian tube cancer, or primary~     peritoneal cavity cancer.~   "
248218|NCT00303875|"~     RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and~     quality of life in older long-term cancer survivors who are overweight.~      PURPOSE: This randomized clinical trial is studying two different schedules of exercise and~     dietary counseling to compare how well they work in improving physical activity, nutrition,~     and quality of life in older long-term cancer survivors who are overweight.~   "
248219|NCT00303862|"~     This phase II trial is studying how well AZD2171 works in treating patients with refractory~     metastatic kidney cancer. AZD2171 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
248220|NCT00303849|"~     This phase I/II trial studies the side effects and best dose of melphalan when given together~     with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well~     they work in treating patients with previously treated brain tumors. Drugs used in~     chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood~     vessels around the brain and allow cancer-killing substances to be carried directly to the~     brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients~     undergoing chemotherapy with carboplatin and BBBD. Giving carboplatin, melphalan, etoposide~     phosphate, mannitol, and sodium thiosulfate together may be an effective treatment for brain~     tumors.~   "
248221|NCT00303836|"~     This randomized phase II trial is studying how well giving vaccine therapy with or without~     interleukin-2 after chemotherapy and an autologous white blood cell infusion works in~     treating patients with metastatic melanoma. Vaccines made from peptides may help the body~     build an effective immune response to kill tumor cells. Giving vaccine therapy with~     interleukin-2, chemotherapy, and an autologous white blood cell infusion may be a more~     effective treatment for metastatic melanoma.~   "
248222|NCT00303823|"~     This randomized phase II trial is studying green tea extract to see how well it works~     compared to a placebo in preventing cervical cancer in patients with human papillomavirus and~     low-grade cervical intraepithelial neoplasia. Chemoprevention is the use of certain~     substances to keep cancer from forming, growing, or coming back. The use of green tea extract~     may stop cervical cancer from forming in patients with human papillomavirus and low-grade~     cervical intraepithelial neoplasia. It is not yet known whether green tea extract is more~     effective than a placebo in preventing cervical cancer in patients with human papillomavirus~     and low-grade cervical intraepithelial neoplasia.~   "
248223|NCT00303810|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving radiation therapy in different ways and~     giving it together with more than one drug (combination chemotherapy) may kill more tumor~     cells. It is not yet known which radiation therapy and combination chemotherapy regimen is~     more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor~     (PNET), or ependymoma.~      PURPOSE: This clinical trial is studying six different radiation therapy and combination~     chemotherapy regimens to compare how well they work in treating young patients with~     medulloblastoma, PNET, or ependymoma.~   "
248224|NCT00303797|"~     This phase I trial is studying the side effects and best dose of sorafenib and bortezomib in~     treating patients with advanced cancer. Sorafenib and bortezomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop~     the growth of cancer cells by blocking blood flow to the cancer~   "
248289|NCT00302913|"~     This study is a prospective, single-center evaluation of the efficacy of clopidogrel dose~     adjustment in patients with insufficient platelet inhibition after elective coronary stent~     implantation.~   "
248290|NCT00302900|"~     Many individuals experience negative reactions when donating blood, including dizziness,~     lightheadedness, or fainting. Such reactions may discourage them from donating again. This~     study will evaluate the effectiveness of pre-donation water consumption and a muscle tensing~     exercise during donation to reduce negative reactions among new blood donors. This study will~     also evaluate whether reducing negative reactions increases the likelihood of donors~     returning to give blood in the future.~   "
248225|NCT00303784|"~     RATIONALE: The increasingly prolonged and extended use of androgen deprivation therapy (ADT)~     in the treatment of prostate cancer, usually achieved through the administration of LHRH~     agonists, has raised concerns about long-term toxicities, in particular osteoporosis and~     adverse metabolic changes which may be associated with type II diabetes and increased~     cardiovascular risk. An alternative approach is to investigate other methods of ADT. Oral~     oestrogen has been shown to be as effective as LHRH and surgical orchidectomy in achieving~     castrate levels of testosterone and has equivalent or improved prostate cancer outcomes but~     is not used routinely as first-line therapy because of the risk of cardiovascular system~     (CVS) complications. The CVS complications have been attributed to first-pass hepatic~     metabolism. Administering oestrogen parenterally avoids the entero-hepatic circulation and so~     is expected to mitigate the risk of CVS toxicity whilst still effectively suppressing~     testosterone to castrate levels. This hypothesis has been supported by results from the early~     stages of this trial which have provided sufficient indication of the safety and efficacy of~     the patches to warrant further investigation of the treatment in this setting, as recommended~     by the IDMC..~      PURPOSE: This randomized phase III trial is studying how well the estrogen skin patch works~     compared with luteinizing hormone-releasing hormone agonist injections in treating patients~     with locally advanced or metastatic prostate cancer.~   "
248226|NCT00303771|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) in~     different doses or combinations may kill more tumor cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating colorectal cancer.~      PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with~     leucovorin with or without irinotecan in treating older patients with metastatic colorectal~     cancer .~   "
248227|NCT00303758|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and~     gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     and giving them in different ways may kill more tumor cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.~      PURPOSE: This randomized phase III trial is studying two different combination chemotherapy~     regimens to compare how well they work in treating patients with metastatic pancreatic cancer~     that cannot be removed by surgery.~   "
248228|NCT00303745|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It~     is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone~     in treating colorectal cancer.~      PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how~     well they work as second-line therapy compared to irinotecan alone in treating older patients~     with progressive, metastatic colorectal cancer that cannot be removed by surgery.~   "
248229|NCT00303732|"~     RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow~     to the tumor and by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and~     everolimus and to see how well they work in treating patients with advanced solid tumors.~   "
248230|NCT00303719|"~     RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that~     were destroyed by chemotherapy and radiation therapy, or that have become cancer. Sometimes~     the transplanted cells from a donor can make an immune response against the body's normal~     cells. Giving cyclophosphamide and fludarabine together with total-body irradiation followed~     by cyclosporine and mycophenolate mofetil before the transplant may stop this from happening.~      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together~     with radiation therapy followed by cyclosporine and mycophenolate mofetil works in treating~     patients who are undergoing a donor stem cell transplant for hematologic cancer, metastatic~     breast cancer, or kidney cancer.~   "
248231|NCT00303706|"~     The purpose of this study is to compare the safety and effectiveness of minimally invasive~     endoscopic harvest of the radial artery to the conventional open method of radial artery~     harvest in coronary artery bypass surgery. The researchers hypothesize that the radial artery~     can be safely, efficiently, and routinely harvested using a minimally invasive endoscopic~     technique. Endoscopic minimally invasive harvesting of the radial artery will reduce the~     postoperative morbidity due to pain, wound infection, and neurological complications and~     improve cosmetic results.~   "
248232|NCT00303667|"~     RATIONALE: Giving chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total~     body irradiation, before peripheral blood stem cell transplant helps stop the growth of~     cancer cells. It may also stop the patient's immune system from rejecting the donor's stem~     cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused~     into the patient they may help the patient's bone marrow make stem cells, red blood cells,~     white blood cells, and platelets. Giving IL-2 (aldesleukin) after NK cell infusion may~     stimulate them to kill any remaining cancer cells.~      PURPOSE: This phase I/II (currently enrolling in phase II) trial is studying how well a donor~     natural killer cell infusion works in treating patients who are undergoing donor stem cell~     transplant for acute myeloid leukemia.~   "
248233|NCT00303654|"~     RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer or~     benign prostatic hyperplasia. Transurethral resection using a loop resectoscope may have~     fewer side effects and improve recovery.~      PURPOSE: This clinical trial is studying how well the loop resectoscope works in treating~     patients with bladder cancer or benign prostatic hyperplasia who are undergoing transurethral~     resection.~   "
248234|NCT00303641|"~     The purpose of this study is to determine if the Medtronic Resting Heart Bypass system is~     safer and results in less inflammatory reaction than traditional bypass machines used in~     coronary artery bypass surgery. We hypothesize that the new Medtronic Resting Heart System is~     safer and results in much less systemic inflammatory reaction in comparison to the standard~     cardiopulmonary bypass systems currently in use.~   "
248235|NCT00303628|"~     Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug~     (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells~     that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and~     fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This~     randomized phase III trial is studying combination chemotherapy to see how well it works with~     or without bevacizumab in treating patients who have had surgery for stage II or stage III~     rectal cancer.~   "
248236|NCT00303615|"~     This study is for patients with breast cancer that has spread to other tissues and organs.~     The purpose of this study is to identify patients who may respond favorably to certain types~     of hormonal therapy. Researchers will study your tumor, which was removed during your breast~     surgery. They will look for the presence or absence of Androgen (AR) receptors. These tests~     are for research purposes only. They will not affect the treatment of your breast cancer. The~     presence or absence of Androgen receptors on the tumor does not alter the therapy that is~     offered to patients. Recent evidence suggests that AR+ tumors are more likely to be destroyed~     when treated with androgen drugs. We will ask about 35 ER-/PR- breast cancer patients from~     Legacy Health System to be in this study. All tests and procedures are done as an outpatient~     in the doctor's office, a clinic, or at the hospital. The study drug that will be used in~     this trial is Androxy®, a synthetic androgen hormone. Androgens have been shown to inhibit~     the growth of some breast cancer cells. Arimidex is an aromatase inhibitor that will be used~     in conjunction with Androxy to inhibit the in vivo production of estrogen. It is hoped that~     the combination of these two drugs will inhibit the growth of your tumor and possibly cause~     it to shrink.~   "
248237|NCT00303602|"~     This study is testing if under the tongue olanzapine for schizophrenia, related psychosis,~     schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that~     is swallowed, in patients who are already gaining weight on olanzapine.~   "
248238|NCT00303589|"~     This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard~     care' in patients with complicated skin and skin structure infections requiring~     hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h~     2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or~     vancomycin, plus aztreonam or ciprofloxacin]. The anticipated time on study treatment is <3~     months and the target sample size is 100-500 individuals.~   "
248239|NCT00303576|"~     Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter~     study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or~     matching placebo gel. The volunteers will receive investigational product for a total of 42~     days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and~     compliance.~   "
248240|NCT00303563|"~     This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and~     symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate~     monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized~     to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study~     treatment is <3 months, and the target sample size is 100-500 individuals.~   "
248241|NCT00303550|"~     The study is now completed~   "
248242|NCT00303537|"~     The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty~     liver disease.~   "
248243|NCT00303524|"~     The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3~     monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol~     suppression in patients with oestrogen receptor positive early breast cancer.~   "
248244|NCT00303511|"~     Review the feasibility, safety and outcomes in adults with congenital heart disease who~     undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications~   "
248245|NCT00303498|"~     The aim of this study was to determine whether long-term (≥ 6 months at the target dose)~     blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with~     chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.~   "
248246|NCT00303485|"~     This study will determine the rapidity of suppression of the bone resorption marker sCTX in~     post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated.~     Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with~     vitamin D and calcium supplementation. The anticipated time on study treatment is~     approximately 7 months, and the target sample size is <100 individuals.~   "
248247|NCT00303472|"~     The purpose of this study is to evaluate the safety and tolerability of romiplostim in~     thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will~     evaluate the platelet response to romiplostim.~   "
248248|NCT00303459|"~     COMPASS-2 is a Phase 4, prospective, randomized, double-blind, placebo-controlled,~     event-driven study evaluating the effect of bosentan on the time to first confirmed~     morbidity/mortality event in patients with symptomatic PAH already receiving sildenafil~     therapy. Patients must have been receiving doses of sildenafil equal to or greater than 20 mg~     t.i.d. for at least 12 weeks prior to being randomized.~      The study continued until the predefined target number of morbidity/mortality events was~     reached.~   "
248291|NCT00302887|"~     The aim of this study was to evaluate the short term and one year follow-up results of~     connective tissue manipulation and combined ultrasound therapy (ultrasound and high voltage~     pulsed galvanic stimulation) in terms of pain, complaint of non-restorative sleep and impact~     on the functional activities in patients with fibromyalgia.~   "
248304|NCT00302718|"~     The purpose of this study was to determine whether financial incentives for~     guideline-recommended treatment of hypertension are effective. We hypothesized that patients~     with hypertension cared for by physicians or practice groups receiving financial incentives~     were more likely to be prescribed guideline-recommended anti-hypertensive medications and~     achieve Joint National Commission (JNC) 7 guideline-recommended blood pressure goals compared~     to patients who were treated by providers that did not receive financial incentives.~   "
248249|NCT00303446|"~     This study will determine if the drug dutasteride can improve weakness, mobility,~     functioning, nerve function, and quality of life in patients with spinal and bulbar muscular~     atrophy (SBMA). Patients with this inherited disease have an abnormal androgen receptor~     protein. The male hormones testosterone and dihydrotestosterone (DHT) bind to this abnormal~     receptor, causing damage to nerve cells that innervate muscle and leading to weakness.~     Dutasteride decreases DHT production. Lowering DHT levels may decrease the harmful effects of~     DHT to the nerves and improve strength in people with SBMA.~      Males 18 years of age and older with SBMA who have neurological symptoms and can walk 100~     feet (with or without assistive devices) may be eligible for this study. Candidates are~     screened with a blood test and a review of their medical records and genetic studies.~      Participants undergo the following procedures:~        -  Blood and urine tests, history and physical examination, assessment of muscle strength~        -  Quality-of-life questionnaire~        -  Tests to assess functional abilities, such walking up steps, keeping the head up while~          lying down, and other measures~        -  Nerve conduction study and motor unit number estimation to assess nerve damage. A probe~          placed on the skin delivers small electrical impulses and wires taped to the skin record~          the impulses.~        -  Quantitative muscle testing to measure strength. The subject pushes and pulls levers~          attached to a gauge. Strength is recorded by a computer.~        -  Medication. Participants are divided into two groups. One group is given the study drug,~          dutasteride; the other receives a placebo (sugar pill). All participants take their~          assigned medication once a day for 24 months.~        -  Follow-up evaluations. Every 6 months for 2 years, participants return to NIH to repeat~          the tests described above to determine the effects of the dutasteride. Nerve and~          quantitative muscle testing is not done at the 6- and 18-month visits.~        -  In addition to their follow-up appointments here at the NIH every 6 months, participants~          will also have blood tests and a physical examination performed after 3, 9, 15 and 21~          months of treatment by the patient's local physician.~   "
248250|NCT00303433|"~     Post Operative Delirium is a common and serious risk of surgery. Delirium, when it occurs is~     associated with an increased risk of mortality, increase length of stay, and more adverse~     outcomes in general, including increased risk of higher level of care required at discharge.~      Namenda, which is currently approved for moderate or severe Alzheimer's disease has a unique~     mechanism of action than other drugs for this condition. It may have the ability to protect~     the brain from more severe consequences of hypoxia, or hypoglycemia. Hence it is being looked~     at in this study to see if it can reduce the incidence and/or severity of delirium~     post-operatively.~   "
248251|NCT00303420|"~     We are investigating a new way of administering alteplase to remove clots from hemodialysis~     catheters. Currently, alteplase is left to dwell inside the catheter between dialysis~     treatments to dissolve the clot and restore blood flow through the catheter. We have~     developed a new way to administer alteplase by advancing it to the tip of the catheter at~     regular 10 minute intervals. We hypothesize that our new push protocol will dissolve clots~     in hemodialysis catheters better and faster than the current dwell method.~   "
248252|NCT00303407|"~     To determine the efficacy and to measure the complications of prophylactic anticoagulation~     using low-molecular weight heparin in adult cancer patients under palliative care~   "
248253|NCT00303394|"~     Aim: To investigate the therapeutic potential of IL-1Ra in type 2 diabetes.~      Rationale: Since the major defect leading to a decrease in b-cell mass in type 2 diabetes is~     increased apoptosis, therapeutic approaches designed to arrest apoptosis could be a~     significant new development in its management. This approach might actually reverse the~     disease to a degree rather than just palliate glycemia. Based on current thinking, treatment~     with IL-1Ra appears as a promising approach. The prospected effect is blocking of the~     IL-1b-mediated glucotoxicity and thereby to prevent the decline in b-cell mass, together with~     a rapid restoration of b-cell function. FDA approval for IL-1Ra in the treatment of~     rheumatoid arthritis occurred based on a favourable tolerability profile.~   "
248254|NCT00303381|"~     The purpose of this study is to determine the safety and efficacy of interferon-beta-1a in~     subjects with active ulcerative colitis (UC).~   "
248255|NCT00303368|"~     The study is a multicenter four-year outcome study of the natural history of tibial dysplasia~     in patients with NF1 and selected patients without NF1. We will obtain information on the~     natural history, burden, functional and health status, health-related quality of life, and~     surgical interventions/outcomes of tibial dysplasia. The project will also establish a Core~     Facility (NOCF) for tissue samples for future studies.~   "
248256|NCT00303355|"~     To assess the utility of clinical bedside examination for the measurement of jugular venous~     pulse in critically ill patients.~   "
248257|NCT00303342|"~     The purpose of this study is to evaluate the change in measures of physiological arousal~     before and after behavioral treatment of insomnia.~   "
248258|NCT00303329|"~     A 1-year randomized Phase II core trial was conducted to investigate the efficacy of~     deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia~     2 years of age and older. Patients who successfully completed the main trial may continue in~     the extension trial to receive chelation therapy with deferasirox for up to 3 years.~     Extension was prolonged to 4 years.~      The objective of this study is to assess the long-term safety and efficacy of deferasirox in~     these patient groups.~   "
248259|NCT00303316|"~     This study will assess both the antibody persistence of the investigational vaccine and the~     immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers~     who participated in an earlier study in order to determine if they are still protected before~     they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the~     quality of the induced immune memory in response to a booster dose of the same vaccine as in~     the primary series.~      Primary Objective:~      To describe the antibody persistence at 18 months of age and the booster effect of a dose of~     PENTAXIM™ on immunogenicity.~      Secondary objective:~      To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by~     the vaccines received during the primary series.~   "
248260|NCT00303303|"~     Most patients bitten by copperhead snakes do not currently receive antivenom. Some snakebite~     victims have long term problems with the function of the limb that was bitten. This study~     will determine whether early administration of antivenom to patients with mild to moderate~     copperhead snakebites reduces long-term complications.~   "
248261|NCT00303290|"~     The goal of this clinical research study is to see if a new interferon which is given only~     once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety of~     this treatment will also be studied.~   "
248302|NCT00302744|"~     Psychiatric Research Study For Cancer Patients~      The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a~     study designed to measure the effectiveness of the novel psychoactive medication psilocybin~     on the reduction of anxiety, depression, and physical pain.~   "
248262|NCT00303277|"~     Recent evidence suggests that there is a significant overlap between AD and cerebrovascular~     disease. In fact, AD and cerebrovascular disease may share some of the same risk factors,~     including hypercholesterolemia. In addition, studies have suggested that the HMG Co-A~     reductase inhibitor lipid-lowering agents, known as statins, decrease the risk of AD by up~     to 70%; however, effects differed by specific statin use. This study will compare two~     statins, simvastatin (which crosses the blood brain barrier) and pravastatin (which does~     not), with respect to their ability to alter blood and cerebrospinal fluid (CSF) levels of AD~     and inflammatory markers. The primary aim of the proposed study is to determine whether there~     is a reduction in Abeta with statins and whether the ability of the statin to cross the~     blood-brain barrier will affect its ability to decrease Abeta. If it can be demonstrated that~     statins alter AD-associated biomarkers, this would have broad implications for the treatment~     and prevention of AD.~   "
248263|NCT00303264|"~     Functional dyspepsia has been defined loosely as pain or discomfort centered in the upper~     abdomen. The symptoms can also include fullness, early satiety, bloating, belching, nausea,~     retching and vomiting. These symptoms may present with or without the co-existence of~     symptoms of heartburn or gastroesophageal reflux disease (GERD). Functional dyspepsia is a~     diagnosis of exclusion in which other disease states, such as ulcer, cancer, etc. are ruled~     out and the source of the pain is unknown.~      The standard of care for most patients presenting with dyspeptic symptoms has been with~     proton pump inhibitors (PPI), regardless of whether or not the patient's symptoms include~     acid-related conditions, e.g., heartburn, GERD, etc. Although PPI treatment has yielded some~     success in these patients, there is a significant population of patients whose dyspeptic~     symptoms are not adequately treated with PPI's alone.~      The purpose of this study is to evaluate the use of dexloxiglumide in the treatment of the~     symptoms of functional dyspepsia in patients whose dyspeptic symptoms are not being treated~     adequately with PPI's.~   "
248264|NCT00303251|"~     This study is an open-label, dose-escalating study to delineate the safety, pharmacokinetics~     (PK), and pharmacodynamics (PD) of TKI258. Pharmacokinetics and pharmacodynamics will be~     performed on all subjects. The eligible subject population consists of subjects who have been~     diagnosed with locally advanced or metastatic melanoma that is refractory to standard therapy~     or for which no curative standard therapy exists.~   "
248265|NCT00303238|"~     The purpose of the study is to evaluate the effect of botanical dietary supplements on~     inflammation in healthy people with different genetic responses to inflammation.~   "
248266|NCT00303225|"~     This study will test an experimental antiviral drug called SIGA-246 for use against the~     smallpox virus (variola). Although smallpox has been universally eradicated, it could~     possibly be brought back as a bioweapon. In the event of a smallpox attack, it would be best~     to have an antiviral medication in addition to the smallpox vaccine. SIGA-246 has shown to~     have activity against other viruses from the same family (orthopoxvirus) that smallpox~     belongs to.~      Healthy volunteers who are 18-50 years of age and are not pregnant or breastfeeding may be~     eligible for this study. Candidates are screened with a medical history and physical~     examination, blood and urine tests, and an electrocardiogram.~      Participants are randomly assigned to receive a one-time dose of SIGA-246 (either 500 mg,~     1000 mg, or 2000 mg) or a placebo (sugar pill) taken by mouth. They report to the clinic in~     the morning for the following procedures:~        -  Insertion of intravenous (IV) line in the forearm.~        -  Blood and urine tests before taking the study drug.~        -  Drug administration within 30 minutes of eating a light breakfast.~        -  Blood sampling from the IV line at 30 minutes and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 5 and 6,~          10 and 12 hours after taking SIGA-246 to determine how the drug is absorbed,~          distributed, broken down and excreted. Samples are also collected by needle stick at 24~          and 48 hours for the same tests.~        -  Electrocardiogram at 2 hours and 24 hours after taking SIGA-246.~        -  24-hour urine collection after taking the SIGA-246.~        -  Complete diary card at home for 7 days after taking the SIGA-246.~        -  Follow-up visits at about 2 weeks and about 4 weeks after taking SIGA-246.~        -  Checks for health changes or problems at every visit.~   "
248267|NCT00303212|"~     The primary purpose of this study is to determine the effectiveness of telemonitoring~     compared with usual guideline-based care in preventing hospitalization for heart failure~     patients.~   "
248268|NCT00303199|"~     The study of safety of a new organic arsenic compound in the treatment of advanced multiple~     myeloma~   "
248269|NCT00303186|"~     The purpose of this study is to conduct an economic analysis on the cost of conventional~     therapy as compared to biologic therapy and the direct/indirect costs of disease management~     in patients with refractory psoriatic arthritis (PsA). Primary outcomes are to qualify the~     economic burden of refractory PsA care. The secondary outcomes are to assess efficacy,~     safety, and cost effectiveness of different therapies.~   "
248270|NCT00303173|"~     Over 10% of women have high blood pressure during their pregnancy which may affect their~     health or that of their baby. There are currently no methods to prevent most high blood~     pressure in pregnancy and some treatments are not desirable for use in pregnancy. Previous~     research indicates that simple relaxation methods can reduce blood pressure and anxiety~     levels for some people, but this has not been well-studied, especially during pregnancy. This~     pilot study is intended to determine how guided imagery (imagining relaxing scenes) affects~     blood pressure and anxiety, and to assess how satisfied women are with this technique.~     Sixty-six pregnant women with high blood pressure will be randomly assigned to (1) listen to~     a guided imagery audio-compact disc or (2) quiet rest, at least twice-daily for 4 weeks. All~     women in both groups will receive all usual care, plus will have their blood pressure~     measured regularly during 1 day per week for 4 weeks. This study will determine if imagery~     lowers maternal blood pressure, and if further research on imagery effects on pregnancy~     health outcomes is feasible.~   "
248271|NCT00303160|"~     This study argues that H.pylori infection, by increasing the production of reactive oxygen~     species, increases the utilization of dietary antioxidants(Vit E and Vit C) that serve in~     quenching the free radicals, thus decreasing their serum levels and confounding their~     protective effect against gastric cancer.~   "
248272|NCT00303147|"~     The purpose of this study is to determine if expressive writing is an effective intervention~     for reducing stress, enhancing cognition, and improving quality of life for caregivers of~     older adults with dementia~   "
248273|NCT00303134|"~     The purpose of this study is to test the safety and efficacy of islet cell transplants for~     the treatment of type 1 diabetes mellitus. It has been shown that normal control of blood~     sugar levels can prevent progression of complications (such as kidney disease, nerve damage,~     and vascular disease) from diabetes. This research study is designed to see if normal blood~     sugar control can be achieved by transplanting pancreatic islet cells into your liver, which~     may reduce or eliminate your need for insulin. Patients may qualify to participate in this~     research study if they have type 1 diabetes mellitus for at least five years and meet at~     least one of the following criteria:~        -  Experience hypoglycemic unawareness - Defined as inability to tell when blood glucose is~          low (for example, may not feel symptoms such as shaking, sweating, and rapid heartbeat~          that usually signify that glucose is low)~        -  Have been hospitalized several times in the past year for low blood sugar and/or high~          blood sugar~        -  Have complications of diabetes such as retinopathy, kidney problems, or neuropathy~   "
248274|NCT00303121|"~     Clinic-based evaluation of patients compliance with topical medications in the treatment of~     glaucoma. Also assessing effectiveness of delivery techniques among these patients.~   "
248275|NCT00303108|"~     The purpose of this study is to determine the ORR associated with Doxil in combination with~     carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).~   "
248276|NCT00303082|"~     The trial intends to evaluate the efficacy of specially designed probiotics to prevent~     premature birth and related neonatal morbidity associated to intra-uterine infection. The~     tested probiotics are efficacious to decrease the prevalence of bacterial vaginosis. The~     study hypothesis is that the early administration of those probiotics to pregnant women with~     bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of~     the immune response to infection.~   "
248277|NCT00303069|"~     This is a randomized, Multicenter, double-blind (subject, investigator, and Merck Research~     Laboratories (MRL) clinical personnel directly involved in the study), placebo-controlled,~     dose-ranging study in healthy adults 18 to 55 years of age. It is the first in man (FIM)~     study evaluating the tolerability and immunogenicity of the 0657nI S. aureus vaccine. For~     this Phase I study, approximately 120 healthy adults will be enrolled in the study and~     randomized to receive a single 0.5 mL vaccination of either 0657nI S. aureus vaccine (3~     different dosage levels of 5 μg, 30 μg or 90 μg of the 0657nI vaccine) or saline placebo.~     Vaccine/placebo will be administered intramuscularly (IM) in the deltoid muscle. Because this~     study will be the first study evaluating the tolerability and immunogenicity of 0657nI S.~     aureus vaccine in humans, a dose-escalation phase will be conducted in a small number of~     subjects randomized in a 3:1 ratio (n=36, consisting of 9 subjects for each of 3 vaccine~     dosage levels and 9 placebo subjects) to evaluate the vaccine safety at increasing dose~     levels of the 0657nI protein in Panel A, before expanding the enrollment to the remaining 84~     subjects in Panel B.~   "
248278|NCT00303056|"~     The primary objective is to compare the overall treatment effect on pain relief between~     icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in~     term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the~     safety of icatibant, to evaluate overall conditions of daily life after treatment with~     icatibant, to assess systemic exposure of icatibant following intra-articular injection.~   "
248279|NCT00303043|"~     In this study the investigators aim to evaluate the utility of a continuous mixed venous~     saturation monitoring compared to a clinical examination in a group of critically ill~     patients.~   "
248280|NCT00303030|"~     A short presentation of a randomized clinical trial of biofeedback and anal injections as a~     first treatment option of faecal incontinence.~      Background: Faecal incontinence affects mainly women who have suffered sphincter disruption~     from vaginal delivery, but individuals of all ages can be affected. The treatment of this~     debility is not uniform between institutions or internationally. Often is surgical~     reconstruction of the anal sphincter performed, or other invasive, costly treatment options.~      The study: We intend to conduct a randomized, controlled, clinical trial where we compare the~     effect of two less invasive, less costly treatment options as a first alternative:~     biofeedback and anal injections. Our hypothesis is that anal injections will give a better~     and more lasting effect than biofeedback. The primary endpoint will be change in faecal~     incontinence assessed by the St. Marks incontinence score. Secondary endpoints will include~     change in quality of life and several physiological parameters. We intend to include 62~     patients in both groups, 124 all together, from 2 centres in Norway. The observation time is~     2 years. We plan to include the first patient April 2006, and conclude the study by December~     2010. This study can contribute to a more appropriate treatment-algorithm for these patients.~      Study group:~        -  Barthold Vonen MD PhD, Department of gastroenterological surgery, University Hospital of~          North Norway~        -  Rolv-Ole Lindsetmo MD PhD, Department of gastroenterological surgery, University~          Hospital of North Norway~        -  Arvid Stordahl MD PhD., Department of Surgery, Østfold Hospital Fredrikstad~        -  Ylva Sahlin MD PhD, Department of Surgery, Innlandet Hospital Hamar~        -  Trond Dehli, MD, Department of gastroenterological surgery, University Hospital of North~          Norway~        -  Kjersti Mevik, Stud. Med, University of Tromso~      Project manager: Trond Dehli~      Funding, approvals, publication: This study is funded from Northern Norway Regional Health~     Authority and The Institution of Norwegian Health- and rehabilitation-organizations. It has~     been approved by the Regional Committee for Medical Research Ethics and Norwegian Social~     Science Data Services. The results will be published in an international peer-reviewed~     journal after the Vancouver-convention's guidelines. The results will also be presented at~     national and international conferences.~      Contact:~      Trond Dehli, Department of gastroenterological surgery, University hospital North Norway,~     Breivika, 9038 Tromsø trond.dehli@unn.no tlf: +47 776 26 000~   "
248281|NCT00303017|"~     safety, efficacy and acceptability of Flavocoxid~   "
248282|NCT00303004|"~     The purpose of this study is to investigate if combination treatment with Bosentan and~     Sildenafil to patients with Eisenmenger syndrome is beneficial.~   "
248283|NCT00302991|"~     Observational, multicentre, epidemiological study to determine the HRQOL of patients with~     epilepsy according to treatment sub-group and to validate the Spanish version of the Adverse~     Events Profile, produced by G. Baker et al. Three treatment groups will be examined: patients~     receiving only a new anti-epilepsy drug (AED), patients receiving a classic AED; patients~     receiving combination therapy.~   "
248284|NCT00302978|"~     We are interested in investigating the functional brain abnormalities of height phobia.~     Subjects will be have a functional MRI scan before and after a course of treatment with~     behavioral therapy.~   "
248285|NCT00302965|"~     Measuring the effectiveness of plasma transfusions in critical care~   "
248286|NCT00302952|"~     Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health~     problem. The purpose of this study is to determine the safety and effectiveness of lovastatin~     for controlling inflammation in mildly active RA.~   "
248287|NCT00302939|"~     This study looks at the causes of anemia in adults of all ages who are referred by their~     primary care physician.~   "
248288|NCT00302926|"~     Aim: To dissociate the effects on plasma concentrations of the inflammatory marker c-reactive~     protein of a negative energy balance and a reduction in body fat stores. Secondly to compare~     CRP with fibrinogen and interleukin-6 (IL-6).~   "
248292|NCT00302874|"~     To improve glycemic control of inpatients admitted to the internal medicine wards, the~     researchers generated a protocol based on intensive insulin treatment for use in all~     inpatients with hyperglycemia.~      The researchers hypothesize that intensive insulin treatment will improve the glycemic~     control and the outcome of hospitalized patients.~      Study Information:~        -  All patients with a history of diabetes admitted to the internal medicine ward were~          enrolled in the study.~        -  At baseline, demographic and clinical information were obtained, including information~          necessary to determine the severity of the illness. Venous capillary blood glucose~          levels were checked 4 times a day by glucometer.~        -  During the pre-intervention period, patients were treated according to the common~          practice in the hospital without any intervention. The study team collected the baseline~          data on the glycemic control and treatment of patients admitted with hyperglycemia.~        -  During the intervention period, the study team visited the ward daily and guided the~          medical staff as to the use of the treatment protocol.~        -  During the post-intervention period, the study team collected the data without active~          intervention in the implementation of the protocol.~        -  Data was collected on the mode of treatment and glycemic control of all hyperglycemic~          patients throughout the study. The incidence of hypoglycemia, complications (myocardial~          infarction, stroke, infections), mortality, transfer to intensive care unit (ICU),~          length of hospitalization, and disposition at discharge were noted.~   "
248293|NCT00302861|"~     This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility,~     safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients~     with previously untreated B-CLL. The length of the controlled portion of the study is two~     years. The study will be conducted at investigative sites in the United States.~   "
248294|NCT00302848|"~     EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort~     study of new users of drospirenone/ethinylestradiol (DRSP/EE),~     levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine~     conditions of medical practice in seven European countries. Baseline survey and semiannual,~     active follow-up are based on postal questionnaires, with validation of reported events by~     the women's treating physicians. A multifaceted 4-level follow-up procedure will be~     established to ensure low loss to follow-up rates. The objective of the study is the~     investigation of the incidence of rare serious adverse events associated with the use of new~     and established OCs, and specifically the incidence of thromboembolic events.~   "
248295|NCT00302835|"~     The objective of the international, multicenter case-control study was to evaluate the~     association between end-stage renal disease (ESRD) and use of non-phenacetin-containing~     analgesics with particular emphasis on combined formulations.~   "
248296|NCT00302822|"~     HIV infection is diagnosed late in a substantial proportion of patients having an increased~     risk of clinical progression (AIDS, new AIDS-defining event or death). The currently~     recommended antiretroviral therapy has suboptimal activity in this setting and potent~     quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate~     candidate as the fourth antiretroviral agent, regarding its activity, its parenteral~     administration avoiding gastrointestinal symptoms that often lead to interruption of~     treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity.~      The aim of this study is to investigate, in a comparative intensification trial, the~     immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral~     therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral~     treatment.~      We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting~     in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve~     immunological restoration, measured as the proportion of patients with more than 200 CD4~     cells per mm3 after 24 weeks of antiretroviral therapy.~   "
248297|NCT00302809|"~     Recent studies suggest that a diet rich in fruit and vegetables can lower blood pressure, and~     a number of lines of evidence suggest that grape products may have such an effect. The~     purpose of this study is to determine whether consuming grape juice lowers blood pressure in~     individuals with pre-hypertension or stage I hypertension.~   "
248298|NCT00302796|"~     A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as~     non-specific, due to the lack of a patho-anatomical diagnosis. This term is not~     satisfactory, since it implies uncertainty for both the patient and the clinician. Modic~     changes have recently been identified as a pain giving patho-anatomical diagnosis for a~     considerable percentage (20-30 %) of LBP patients. The causes of these Modic changes have not~     been determined conclusively but bacterial infection is among the plausible causes for those~     following a disc herniation.~      Purpose The aim of this study is to assess the clinical effect of antibiotic treatment~     compared to placebo, in patients with LBP and Modic changes following a lumbar herniated~     disc.~      Design A double blind prospective clinically controlled trial. Patients will be randomized by~     a blinded observer to either Group A: 1 antibiotic tablet 45 patients Group B: 1 placebo~     tablet 36 patients Group C: 2 antibiotic tablets 45 patients Group D: 2 placebo tablets 36~     patients~      The patients will take the drug three times a day for 100 days.~   "
248299|NCT00302783|"~     The purpose of this study is to test whether multi-source feedback, including self-assessment~     and tailored coaching, improves resident communication skills and professionalism. We~     hypothesize that residents who are assigned to receive multi-source feedback, in addition to~     receiving standard feedback, will improve significantly more than residents receiving~     standard feedback alone, as measured by parent and nurse ratings of specific behaviors over~     time.~   "
248300|NCT00302770|"~     This trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized~     type. The following elements of response will be tested: number of responders to treatment,~     time to response, effect size as measured with the LSAS~   "
248301|NCT00302757|"~     The study evaluates the additional use of radioimmunotherapy with a 90-Yttrium labeled~     monoclonal antibody targeting lymphoma cells in two dose reduced conditioning regimens for~     allogeneic hematopoietic cell transplantation from human leukocyte antigen (HLA)-identical~     donors. Radioimmunotherapy should allow an increased anti-lymphoma effect of the conditioning~     while the allogeneic grafts may confer potent graft versus lymphoma effects and rescue from~     potential hematopoietic side effects of the radioimmunotherapy. The study evaluates the~     feasibility and toxicity of such approach and will also analyze disease response and survival~     of the patients treated.~   "
248305|NCT00302705|"~     This study was designed in order to evaluate the blood pressure lowering effect of valsartan~     compared to enalapril over 24 hours after skipping one daily dose. Both drugs act on the~     renin-angiotensin-aldosterone system (RAAS) and are widely use for the treatment of~     hypertension. Previous studies had a significant limitation: the effect of a missing dose was~     not evaluated after the whole 24 hours post missing dose period (48 hours after last taken~     dose), and as a result, it does not imitate the real life situation of a missing dose.~   "
248306|NCT00302692|"~     Advances in medical care have increased the proportion of elderly Americans and enabled them~     to remain more physically active. This has resulted in an unprecedented increase in the~     number of geriatric patients admitted to trauma centers. The elderly constitute 23% of trauma~     center admissions, but 36% of all trauma deaths. This disproportionately high mortality is~     attributable to a higher prevalence of pre-existing conditions, particularly, cardiac~     disease. Multi-system injuries result in critical cardiac stress. Although beta-blockade has~     been shown to decrease morbidity and mortality in patients at risk for myocardial infarction~     after elective surgery, their use in trauma patients with potential underlying cardiac~     disease has not been previously studied. We hypothesize that routine administration of~     beta-blockers after resuscitation will reduce morbidity and mortality in elderly trauma~     patients with, or at risk for, underlying cardiac disease.~      This study is a randomized, prospective clinical trial. One cohort will receive routine~     trauma intensive care, and the other, the same care plus beta-blockade after completion of~     resuscitation. The primary outcome will be mortality. Secondary outcomes include MI, length~     of stay, organ dysfunction, cardiac, and other complications.~      Changes in outcome may not be due to reduction in myocardial oxygen demand and heart rate.~     Laboratory studies demonstrate that circulating inflammatory cytokines contribute to cardiac~     risk in trauma patients, and their production is influenced by adrenergic stimulation. We~     will measure circulating IL-6, TNF alpha, IL-1beta, and measure NF-kB and p38 MAP kinase~     activation in peripheral blood leukocytes, and determine the effect of beta-blockade on the~     production of these inflammatory markers.~      Finally, the wide variation in patient response to beta-blockers is attributed to genetic~     variability in the adrenergic receptor. Therefore, we will identify single nucleotide~     polymorphisms (SNPS) within the beta-adrenergic receptor, and determine their effects on~     mortality and response to beta-blockade. This study will provide the first randomized,~     prospective trial designed to reduce morbidity and mortality in elderly trauma patients at~     risk for cardiac disease. The laboratory and genetic component will provide additional~     insights that may explain treatment effects, lead to new therapeutic strategies, and have the~     potential to lead to additional areas of investigation.~   "
248307|NCT00302679|"~     According to experience in a self-payed health check-up center,unsedated total colonoscopy is~     not inferior or may be better than unsedated sigmoidoscopy in terms of pain and patients'~     acceptance.~      Hypothesis: Unsedated total colonoscopy is not inferior to unsedated sigmoidoscopy in terms~     of pain and patients' acceptance.~   "
248308|NCT00302666|"~     The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy~     and safety of this oral contraceptive in two different regimens of intake.~   "
248309|NCT00302653|"~     The purpose of this study is to determine whether rasburicase is effective and safety in~     correcting hyperuricemia.~   "
248310|NCT00302640|"~     The purpose of this study is to determine the effect of nitazoxanide suspension in treating~     diarrhea caused by enteric viruses in children less than 12 years of age.~   "
248311|NCT00302627|"~     Bone is lost rapidly and fractures occur in 10-20% of patients who receive organ transplants~     within 2 years. The purpose of this study is to evaluate long-term effects of a~     pamidronate-vitamin D-calcium regimen on bone loss, fractures, and safety in recipients of~     kidney and heart transplants.~   "
248312|NCT00302614|"~     Investigate the role of clinical parameters in predicting the severity of obstructive sleep~     apnea~   "
248313|NCT00302601|"~     The purpose of this study is to~        -  investigate which method and criterion for diagnosing pulmonary embolism is the best and~        -  determine the relationship between blood vessel constriction and clot size in patients~          developing heart failure~   "
248314|NCT00302588|"~     Investigate the final diagnosis and treatment result of metastatic cervical carcinoma of~     unknown primary~   "
248315|NCT00302575|"~     The main purpose of this study is to examine whether improved integration between the~     community supervision system and outpatient addiction treatment system can improve treatment~     adherence, drug use and public safety outcomes among drug-involved inmates re-entering the~     community.~   "
248316|NCT00302562|"~     Investigate the role of MMPs in the CXCL12-induced invasion of laryngeal and hypopharyngeal~     squamous cell carcinoma~   "
248317|NCT00302549|"~     1. To compare the efficacy of FK506 vs intravenous cyclophosphamide pulses in the treatment~          of class III-IV LN.~        2. To compare the safety and tolerability of FK506 vs intravenous cyclophosphamide pulses~          in the treatment of class III-IV LN.~        3. To explore the dosing of FK506 and its effective range of blood concentration.~   "
248318|NCT00302536|"~     The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with~     idiopathic focal segmental glomerulosclerosis.~   "
248319|NCT00302523|"~     The purpose of this study is:~        -  To explore the potential role of tacrolimus in the treatment of membranous nephropathy.~        -  To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus~          cyclophosphamide.~   "
248320|NCT00302510|"~     The purpose of this study is to assess the efficacy and safety of immunoadsorption in the~     treatment of lipoprotein glomerulopathy.~   "
248321|NCT00302497|"~     The long-term use of calcineurin inhibitors in the maintenance phase after kidney~     transplantation is associated with typical adverse effects, such as potential contribution to~     progressive impairment of renal function, hypertension, and metabolic abnormalities.~      This 15 month study with a safety follow up is undertaken to evaluate the potential benefit~     of an alternative treatment strategy to the chronic use of CNI. It will establish, through a~     comparative design, the superior protection of kidney function provided by chronic usage of~     basiliximab over tacrolimus early post-transplantation using EDC kidneys.~   "
248322|NCT00302484|"~     Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in~     a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver~     function, immunosuppressive therapy (especially corticosteroids) after transplantation~     increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate,~     slows down the destruction of bone. The purpose of this study is to determine whether~     bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive~     therapy after liver transplantation.~   "
248323|NCT00302471|"~     This two part study will evaluate the safety and tolerability of MK0429 in addition to~     assessing it's pharmacokinetic profile and pharmacodynamic response.~   "
248337|NCT00302289|"~     The primary aim was to measure the effect of green tea extract, tyrosine and caffeine on~     energy expenditure, appetite ratings and spontaneous energy intake together with recording of~     side effects in healthy normal weight subjects.~   "
248324|NCT00302458|"~     This is a double-blind, randomized, placebo-controlled, five-period crossover study to~     examine the likability of a repeated administration of immediate release methylphenidate~     hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses~     are as follows:~        -  Hypothesis 1: the subjective feelings of detection and likeability will be greater for~          periods of IR-MPH administration than after OROS-MPH administration irregardless of~          sequence;~        -  Hypothesis 2: the greater ratings of feelings of detection and likeability will be~          associated with the periods of most rapid change in plasma d-MPH and not with the~          magnitude of plasma d-MPH concentration (other than the OROS-MPH to IR-MPH condition in~          which they coincide), and~        -  Hypothesis 3: the subjective feelings of dislike will be greatest for the two conditions~          in which IR-MPH is the second condition.~   "
248325|NCT00302445|"~     An open label, single arm study to evaluate the study and efficacy of efalizumab in~     combination with NB-UVB. Weeks 1-12 efalizumab will be administered once a week in~     combination with NB-UVB three times per week. Weeks 13-24 efalizumab monotherapy will~     continue. Weeks 25-36 subjects will be followed for safety.~      Subjects with moderate to severe plaque psoriasis often require more than one therapy to~     treat their disease. Because of the different mechanisms of action, it is thought that~     combined efalizumab and NB-UVB may be more effective and have a more rapid onset than either~     treatment alone.~   "
248326|NCT00302432|"~     This study aims:~      1. to assess the effect of smoking reduction programs (behavior therapy alone or behavior~     therapy with cigarette holders; Flowers Menthol plastic cigarettes with menthol) on~     cigarette smoking habits in an antipsychotic treated schizophrenia population.~   "
248327|NCT00302419|"~     The investigators hypothesized that complementary intracoronary streptokinase administration~     to primary percutaneous intervention in patients with acute myocardial infarction may provide~     further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ~     formed or embolized from proximal site (spontaneous or following PCI)] and fibrin.~   "
248328|NCT00302406|"~     This is a single-blind study looking at the efficacy and satisfaction of Concerta~     substitution in adult subjects with ADHD receiving immediate release methylphenidate.~     Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or~     Concerta. The specific hypotheses of this study are:~      Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled~     in patients switched from MPH IR TID to Concerta.~      Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to~     Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with~     MPH IR TID.~   "
248329|NCT00302393|"~     There are two specific aims of this study. The first is to document the pharmacokinetics of~     dopamine transporter (DAT) receptor occupancy of repeated administration of orally~     administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride~     (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) using positron emission tomography~     (PET) scanning with C-11 altropane as the ligand. The investigators hypothesize that central~     nervous system (CNS) DAT occupancy of the OROS-MPH to IR-MPH sequence will be greater than~     that of IR-MPH to OROS-MPH sequence at 5 hours after the initial administration and that the~     CNS DAT occupancy of the other two formulations will be intermediate.~      The second aim of this study is to assess whether the abuse liability potential of delayed,~     repeated administrations of different formulations of MPH is moderated by the oral delivery~     system in which a delivery system with slower onset may be safer than one with more rapid~     early release.~   "
248330|NCT00302380|"~     The primary objective of this study is to evaluate the Binding Potential in subjects with~     ADHD and adults without ADHD: the intent being to demonstrate that C-11 Altropane PET can be~     used to differentiate adults with ADHD from healthy control subjects.~   "
248331|NCT00302367|"~     The specific aim of this study is to document the pharmacokinetics of DAT receptor occupancy~     of OROS and immediate release (IR) MPH using PET scanning with C-11 altropane as the ligand.~     We hypothesize that the time to maximal receptor occupancy and the degree of receptor~     occupancy of immediate release (IR) MPH will be shorter and greater (respectively) than with~     an equipotent dose of OROS MPH.~   "
248332|NCT00302354|"~     This is a double-blind, placebo-controlled study, three-period crossover study to examine the~     likeability of a single dose of OROS MPH (CONCERTAÒ 90mg) and a single dose of Long-acting~     MPH (RITALIN LAÒ 90mg). Hypotheses are as follows:~      Hypothesis 1: OROS-MPH (CONCERTAÒ) will be later than SODOS-MPH (RITALIN LAÒ) in its Tmax~     (time to Cmax).~      Hypothesis 2: The subjective feelings of detection and likeability would be greater for~     SODOS-MPH (RITALIN LAÒ) than for an equivalent total dose of OROS-MPH (CONCERTAÒ).~   "
248333|NCT00302341|"~     The purpose of this study is to demonstrate the non-inferiority of pafuramidine maleate~     (DB289)versus trimethoprim-sulfamethoxazole (TMP-SMX)for the treatment of mild to moderately~     severe Pneumocystis pneumonia (PCP).~   "
248334|NCT00302328|"~     The project is a randomized clinical trial with a follow up time of 12 months comparing the~     effects of surgical treatment of idiopathic macular holes. Patients are randomized to~     vitrectomy alone, vitrectomy plus indocyanine green (ICG) assisted inner limiting membrane (~     ILM) peeling or vitrectomy plus trypan blue (tb) assisted ILM peeling. At baseline patients~     are characterized using early treatment diabetic retinopathy study (ETDRS) visual charts,~     tests of aniseikonia, optical coherence tomography 3 (OCT3), visual field and fundus~     photography. Per- and postoperative complications are registered.~      Data analyses will help clarify the effect of ILM peeling on hole closure and visual acuity.~     Comparing results after ICG- and tb assisted ILM peeling will help clarify the topic of a~     toxic effect on retinal cells after staining and peeling of the ILM. Changes in intraretinal~     morphology before and after dye-assisted ILM peeling will be studied using OCT3 imaging and~     the patients' subjective opinion on the surgical results will be analyzed using quality of~     life questionnaires and metamorphopsia tests.~   "
248335|NCT00302315|"~     This study aims to investigate the effectiveness of physiotherapy applications in early~     postcesarean problems.~   "
248336|NCT00302302|"~     The purpose of this study is to investigate the effect of L-arabinose in a sugar-rich meal on~     intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and~     insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose.~   "
248338|NCT00302276|"~     The objective of the present study was to investigate the acute and sub-chronic effect of a~     supplement containing green tea extract, capsaisin, caffeine, tyrosine and calcium or placebo~     taken t.i.d on thermogenesis, body fat loss, and fecal fat excretion. Furthermore, if a~     8-week supplementation could prevent weight-regain after initial 4-week weight loss.~   "
248339|NCT00302263|"~     To investigate the 5-hour acute effect on energy expenditure, substrate oxidation and ad~     libitum food intake after intake of the Metobes-compound (green tea extract, capsaicin,~     tyrosine, caffeine). Furthermore, to investigate if the effect of the Metobes-compound can be~     inhibited by blocking the β-adrenergic receptors.~      The effect of the Metobes-compound will be investigated by:~        1. 5-hour energy expenditure and respiratory quotient (ventilated hood).~        2. 5-h change in blood pressure and heart rate~        3. 5-h change in sympathetic/parasympathetic ratio.~        4. Ad libitum energy intake.~        5. Self-reported postprandiel appetite sensations (VAS).~   "
248340|NCT00302250|"~     The primary objective of the double-blind segment is to compare effects of alagebrium vs~     placebo on change from baseline in endothelial function, as assessed by flow-mediated~     vasodilation (FMD).~   "
248341|NCT00302237|"~     The purposes of the registry are: 1) To provide an ongoing post-market surveillance mechanism~     to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and~     RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions.~     3) To evaluate the adequacy of Abbott Vascular's physician training program.~   "
248342|NCT00302224|"~     The study is designed to test the safety, tolerability of a newly developed form of~     ketoconazole (DIO-902) for the treatment of elevated blood sugars in type 2 diabetes. This~     study also will also examine the effect of the drug on total and LDL cholesterol and blood~     pressure. Elevated cortisol may contribute to the development of Type II diabetes. The~     investigational drug DIO-902 may reduce the level of cortisol in blood and therefore provide~     better control of blood sugar levels in patients with Type II diabetes.~   "
248343|NCT00302211|"~     The purpose of this multi-center international trial is to evaluate the safety and~     effectiveness of adding iloprost or placebo (an inactive substance that contains no active~     study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will~     also examine whether patients on sildenafil can reduce the number of iloprost inhalations~     from the approved 6 doses per day to 4 doses per day.~   "
248344|NCT00302198|"~     The purpose is to collect data for ALS research. The data will be used to learn more about~     the origin of ALS and to improve quality of care for people with ALS. The information you~     provide in the ALS registry will be used to evaluate variations in patient care, adherence to~     standards of care and also to help foster ALS research.~   "
248345|NCT00302185|"~     Research question: Can acupuncture improve symptom control and quality of life (QOL) in~     patients with advanced incurable cancer?~      The purposes of this study is to investigate the feasibility of performing a randomized trial~     with acupuncture in improving symptom control and quality of life (QOL) in patients with~     advanced incurable cancer at the BC Cancer Agency, Vancouver Island Centre in Victoria.~      We will:~        -  Evaluate whether subjects who are receiving palliative care for cancer related symptoms~          can tolerate and complete to a course of acupuncture treatments.~        -  Evaluate whether it is possible to conduct a study using acupuncture on cancer patients.~   "
248346|NCT00302172|"~     To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.~   "
248347|NCT00302159|"~     Background:~        -  Radiation therapy with temozolomide (an anti-cancer drug) is standard therapy for~          treating brain tumors called glioblastomas.~        -  The drug valproic acid, currently approved for treating seizures, has been shown in~          laboratory tests to increase the radiosensitivity of glioma cells.~      Objectives:~      -To determine the effectiveness of adding valproic acid to standard treatment with radiation~     therapy and temozolomide for treating glioblastoma.~      Eligibility:~      -Patients 18 years of age and older with glioblastoma multiforme who have not been previously~     treated with chemotherapy of radiation.~      Design:~        -  This Phase II trial will enroll 41 patients.~        -  Patients will receive radiation therapy to the brain once a day, Monday through Friday,~          for 6 1/2 weeks.~        -  Patients will take temozolomide once a day by mouth, Monday through Friday, during the~          period of radiation treatment. Starting 4 weeks after radiation therapy, patients will~          take temozolomide once a day for 5 days every 28 days for a total of six cycles.~        -  Patients will receive valproic acid by mouth twice a day beginning 1 week prior to the~          first day of radiation therapy and continuing until the completion of chemotherapy and~          radiation therapy.~        -  Patients will have follow-up visits 1 month after completing therapy, then every 3~          months for 2 years, and then every 6 months for 3 years. Follow-up includes a physical~          examination, blood tests and magnetic resonance imaging of the brain.~   "
248348|NCT00302146|"~     This study will use positron emission tomography (PET) to compare how people with Gaucher~     disease or Gaucher disease carriers with parkinsonism, and their family members, use dopamine~     in their brains in comparison with healthy normal volunteers and people who have Parkinson~     disease. PET assesses organ function by measuring metabolism. In this study, magnetic~     resonance imaging (MRI) is used in conjunction with PET to help better interpret and~     understand the information gleaned from PET.~      People 21 years of age and older with the following conditions may be eligible for this~     study:~        -  Gaucher disease and parkinsonism~        -  Parkinsonism and a family history of Gaucher disease~        -  Gaucher disease and a family history of parkinsonism~        -  Gaucher disease carriers who have parkinsonism or a family history of parkinsonism~        -  Unaffected people with a family history of Gaucher disease and parkinsonism~        -  Healthy volunteers~      Participants undergo the following tests and procedures:~        -  Personal and family medical history~        -  Physical examination~        -  PET scan: The subject lies on a table that slides into the PET scanner until his or her~          head is positioned properly in the scanner. A catheter is inserted into a vein. An~          initial scan is done to obtain images before radionuclides are injected. Radioactive~          water is then injected through the catheter and the subject is asked questions in order~          to stimulate blood flow in certain areas of the brain to show what parts of the brain~          are activated. Fluorodopa is then infused through the catheter over 3 minutes. The PET~          scan can last up to 2 hours.~        -  MRI scan: This test uses a magnetic field and radio waves to obtain images of organs.~          The subject lies still on a bed in the middle of a circular scanner for about 30~          minutes.~   "
248349|NCT00302133|"~     The purpose of this study is to test the efficacy of naltrexone and valproate in the~     treatment of comorbid bipolar disorder and alcohol dependence.~   "
248350|NCT00302120|"~     The purpose of this study is to determine whether performing MRI of the breast will improve~     breast cancer management by reducing the number of biopsies and in case of malignancy~     allowing one-stage surgical excision of the tumor.~   "
248616|NCT00298558|"~     The purpose of the ACTIVE study was to test if cognitive training interventions could~     maintain functional independence in elders by improving basic mental abilities, with~     follow-up assessments through five years.~   "
248351|NCT00302107|"~     Objective: To study the efficacy and tolerability of mirtazapine (Remeron) in the treatment~     of PTSD.~      Research Design: This is an 8-week randomized, double-blind, placebo-controlled treatment~     trial of mirtazapine for the treatment of PTSD as defined on the Clinical Assessment of PTSD~     Scale (CAPS).~      Methodology: After signing an informed consent and meeting all inclusion/exclusion criteria,~     the patient is randomized to either mirtazapine versus placebo for 8-week duration. During~     the study a pharmacist maintains the randomization log and verifies the order for the placebo~     or mirtazapine in look-a-like tablets. Patients' symptoms, side effects and compliance are~     assessed bi-weekly. Based on symptomology and occurrence of side effects, the investigator~     increases the medication in 15 mg increments, as tolerated, until a maximum therapeutic~     benefit is achieved, not to exceed 45 mg/day. The dosing is at bedtime. Compliance is~     assessed by bi-weekly pill count at week 4 and week 8. Patients are given supportive clinical~     management during the clinic visits. An investigator is available by telephone 24 hrs a day~     in case of emergency. Patients may be seen more often if needed. Efficacy will be measured by~     the following assessment scales: Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton~     Anxiety Scale (Ham-A), Clinical Global Impression Severity of Illness (CGI-s), Clinical~     Global Impression of Improvement (CGI-I), Global Assessment of Functioning (GAF), CAPS,~     Treatment Outcome PTSD rating scale (TOP-8), and Davidson Trauma Scale (DTS).~      Clinical Significance: Mirtazapine has shown promise in treating PTSD in an open label trial.~     This study is the next step in proving mirtazapine's efficacy in treatment of PTSD.~   "
248352|NCT00302094|"~     CT-examinations are used in computer programs which are used in the planning of external~     radiation of cancers in the anal canal. In CT the structures of the anal canal are hardly~     visible. 3D-ultrasound examinations offer a better visualisation of normal and pathological~     structures of the anal canal. The description of the tumour made from the 3D-ultrasound~     examination is used in the planning of the external radiation.~      PET-CT is used to visualise tumour activity also in lymp nodes. The hypothesis of the study~     is that image fusion of PET, CT and 3D-ultrasound will offer better visualisation of tumour~     and hereby more accurate diagnostics and treatment.~   "
248353|NCT00302081|"~     This is a randomized, open-label, multinational study designed to evaluate the standard~     regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm~     PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously~     once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.0/R (24 weeks)], using a 24 week~     treatment duration for both arms. Additionally, the study examined the efficacy of reduced~     treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg~     for 16 weeks [Arm PEG2b 1.5/R (16 weeks)] .~   "
248354|NCT00302068|"~     Some individuals with coronary heart disease (CHD) suffer from depression and use~     antidepressant medications to reduce symptoms. However, preliminary research has shown that~     exercise may be a more effective way to treat depression in these individuals. The purpose of~     this study is to evaluate the effects of exercise in reducing depression and improving heart~     function in individuals with CHD.~   "
248355|NCT00302055|"~     The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention~     resulting in modest weight loss and increased physical activity can delay or prevent the~     development of type 2 diabetes in those at increase risk for the disease. The lifestyle~     program used, however, was not designed for delivery on a public health scale. Successful DPP~     translation will require a sustainable partnership between a health care system and an~     established community organization committed to community health and experienced in~     implementing sustainable health and wellness programs. We have been collaborating with local~     health system and community administrators for over a year to design a 'real-world'~     clinic-based screening model to identify and refer high-risk patients for a group-based~     adaptation of the DPP lifestyle intervention in community facilities. We have designed this~     study to develop preliminary data about the feasibility and yield of clinic-based screening~     and referral, as well as the effectiveness of the adapted lifestyle intervention. This pilot~     study seeks to: 1) evaluate the feasibility of a strategy to implement American Diabetes~     Association (ADA) recommendations for clinic-based diabetes-risk testing and to refer~     high-risk patients for a community-based lifestyle intervention; 2) compare two strategies to~     enhance community-based program participation by referred patients; 3) demonstrate the~     capability of community facilities to schedule and enroll referred clinic patients at~     high-risk for diabetes and to deliver a modified, group-based DPP lifestyle intervention~     consistently; and 4) compare levels of weight loss and physical activity achieved by referred~     clinic patients with pre-diabetes who participate in a free-of-charge, group-based DPP~     lifestyle intervention at community facilities compared to a free-of-charge, traditional,~     one-on-one DPP lifestyle intervention at a DPP research site. Addressing these issues now~     will enable us to evaluate this partnered DPP translation model with a larger, more robust~     future study that will involve referral by multiple primary care clinics, program delivery at~     more community sites, and a 3-year follow-up period.~   "
248356|NCT00302042|"~     The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention~     resulting in modest weight loss and increased physical activity can delay or prevent the~     development of type 2 diabetes in those at increased risk for the disease. The lifestyle~     program used, however, was not designed for delivery on a public health scale. Successful~     community translation of the DPP's findings will require close collaboration with an~     established community organization committed to improving community health and experienced in~     implementing sustainable health and wellness programs. With exceptional reach into diverse~     U.S. communities, the Young Mens Christian Association (YMCA) may be an ideal community~     partner. We have been collaborating with the YMCA organization for over a year to design a~     robust recruitment and implementation model that is sensitive to the unique needs and~     resources of a community organization. We now propose to evaluate if a group-based adaptation~     of the DPP lifestyle intervention can be successfully implemented by YMCA staff, in YMCA~     facilities. We have designed this study to develop preliminary data about the reach,~     effectiveness, and consistent implementation of the DPP lifestyle intervention in this~     context. This pilot study has two primary aims: 1) to demonstrate the extent to which YMCA~     staff trained by DPP study personnel can administer a group-based adaptation of the DPP~     lifestyle intervention in a fashion consistent with DPP intervention protocols, and 2) to~     evaluate if the intervention program delivered by the YMCA results in changes in body mass,~     physical activity, and dietary intake that are consistent with a level found to be associated~     with diabetes risk reduction during the DPP trial. We will also collect valuable data about~     the feasibility and reach of a selective, community-based marketing and screening approach~     for recruiting program participants. In combination, these data will enable us to design and~     conduct a larger, future 3-year trial focusing on the effectiveness and sustainability of~     community DPP translation in multiple YMCA settings.~   "
248357|NCT00302029|"~     The purpose of this study is to find out more about cytomegalovirus (CMV) and how it is~     spread between people. One thousand adolescent males ages 12-17 years will participate in~     this study. Participants will be given a questionnaire about risk factors for CMV. A small~     blood sample (2-3 teaspoons) will be taken to test for CMV infection. Subjects that are CMV~     seronegative may participate in the second part of this study, which will involve returning~     to the clinic at regularly scheduled visit times to provide blood, urine, and saliva (spit)~     samples. This part of the study will take at least 24 months to complete. Subjects that test~     positive for CMV during the 2nd portion of the study will be invited to participate in the~     3rd part of the study. This part of the study will require 8 regularly scheduled visits to~     provide blood, urine and saliva samples, over a 12-month period. The maximum amount of time a~     subject will participate in the study is 36 months.~   "
248637|NCT00298285|"~     The primary aim is to determine the rate of major bleeding and blood clots when using~     enoxaparin as a bridge to oral blood thinning medication in patients who have undergone~     mechanical valve replacement.~   "
248359|NCT00302003|"~     This phase III trial is studying how well combination chemotherapy works when given before~     radiation therapy and/or additional chemotherapy in treating young patients with newly~     diagnosed Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug~     (combination chemotherapy) and giving them together with radiation therapy may kill more~     cancer cells.~   "
248360|NCT00301990|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Interleukin-2 may stimulate the~     white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with~     interleukin-2 works in treating patients with metastatic kidney cancer.~   "
248361|NCT00301964|"~     This phase II trial is studying how well bevacizumab works in treating patients with~     recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.~   "
248362|NCT00301951|"~     RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant helps stop both~     the growth of cancer cells and the patient's immune system from rejecting the donor's stem~     cells. When the healthy stem cells from a donor are infused into the patient, they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells. Giving chemotherapy, such as fludarabine and busulfan, and antithymocyte~     globulin before transplant and tacrolimus and mycophenolate mofetil after transplant may stop~     this from happening.~      PURPOSE: This clinical trial is studying how well giving low-dose fludarabine and busulfan~     together with anti-thymocyte globulin, followed by donor umbilical cord blood transplant~     works in treating patients with advanced hematologic cancer.~   "
248363|NCT00301938|"~     This phase I trial is studying the side effects and best dose of 7-hydroxystaurosporine when~     given together with perifosine in treating patients with relapsed or refractory acute~     leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes. 7-Hydroxystaurosporine~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as perifosine, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Giving~     7-hydroxystaurosporine together with perifosine may kill more cancer cells.~   "
248364|NCT00301925|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy~     after surgery may kill any remaining tumor cells. It is not yet known which combination~     chemotherapy regimen is more effective in treating early stage breast cancer that has been~     removed by surgery.~      PURPOSE: This randomized phase III trial is studying four different combination chemotherapy~     regimens to compare how well they work in treating patients with early stage breast cancer~     that has been removed by surgery.~   "
248365|NCT00301912|"~     RATIONALE: Drugs used in chemotherapy, such as busulfan and fludarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy with a peripheral stem cell or bone marrow transplant may allow~     more chemotherapy to be given so that more cancer cells are killed. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Tacrolimus and methotrexate may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving busulfan together with fludarabine~     before donor stem cell transplant works in treating patients with hematologic cancer.~   "
248366|NCT00301899|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab and pertuzumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Giving trastuzumab~     together with pertuzumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving trastuzumab together with pertuzumab~     works in treating patients with unresectable locally advanced or metastatic breast cancer~     that did not respond to previous trastuzumab.~   "
248367|NCT00301886|"~     RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other~     symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective~     than ibandronate in preventing bone problems caused by bone metastases due to breast cancer.~      PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works~     compared to ibandronate in preventing bone problems in women with stage IV breast cancer that~     has spread to the bone.~   "
248368|NCT00301873|"~     RATIONALE: Zoledronate may prevent bone loss in patients with primary malignant glioma.~      PURPOSE: This phase II trial is studying how well zoledronate works in preventing~     osteoporosis in patients with primary malignant glioma.~   "
248369|NCT00301860|"~     RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps~     stop both the growth of cancer cells and the patient's immune system from rejecting the~     donor's stem cells. When the healthy stem cells from a donor are infused into the patient,~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets. Sometimes the transplanted cells from a donor can make an immune response~     against the body's normal cells. Giving chemotherapy, such as fludarabine and melphalan, and~     antithymocyte globulin before transplant and cyclosporine and methotrexate after transplant~     may stop this from happening.~      PURPOSE: This clinical trial is studying how well donor stem cell transplant, using low-dose~     chemotherapy and antithymocyte globulin, followed by donor white blood cell infusions work in~     treating young patients with hematologic cancer.~   "
248370|NCT00301847|"~     This phase II trial is studying how well sorafenib works in treating patients with kidney~     cancer that has spread to the brain. Sorafenib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
248371|NCT00301834|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as fludarabine and busulfan, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. A peripheral stem cell, bone~     marrow , or umbilical cord blood transplant may be able to replace blood-forming cells that~     were destroyed by chemotherapy. Sometimes the transplanted cells from a donor can make an~     immune response against the body's normal cells. Giving cyclosporine together with~     methotrexate and methylprednisolone may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving alemtuzumab together with~     fludarabine and busulfan works when given before donor stem cell transplant in treating young~     patients with hematologic disorders.~   "
248372|NCT00301821|"~     RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill~     more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal~     antibody therapy together with combination chemotherapy works in treating patients with stage~     II, stage III, or stage IV diffuse large B-cell lymphoma.~   "
248373|NCT00301808|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving more than one chemotherapy drug (combination chemotherapy) together with radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium~     together with radiation therapy followed by docetaxel works in treating patients with stage~     III non-small cell lung cancer.~   "
248374|NCT00301795|"~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Oblimersen may help rituximab work better by~     making cancer cells more sensitive to the drug. This phase II trial is studying how well~     giving rituximab together with oblimersen works in treating patients with stage II, stage~     III, or stage IV follicular non-Hodgkin's lymphoma~   "
248375|NCT00301782|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, vincristine, bleomycin,~     carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. It is not yet known which~     combination chemotherapy regimen is more effective in treating germ cell tumors.~      PURPOSE: This randomized phase II trial is studying two different combination chemotherapy~     regimens to compare how well they work in treating male patients with germ cell tumors.~   "
248376|NCT00301769|"~     This phase I trial is studying the side effects and best dose of SJG-136 in treating patients~     with relapsed or refractory acute leukemia, myelodysplastic syndromes, blastic phase chronic~     myelogenous leukemia, or chronic lymphocytic leukemia. Drugs used in chemotherapy, such as~     SJG-136, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing.~   "
248377|NCT00301756|"~     This phase II trial studies how well belinostat works in treating patients with ovarian~     epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that have spread to~     other places in the body or ovarian low malignant potential tumors. Belinostat may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
248378|NCT00301730|"~     RATIONALE: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the~     immune system in different ways and stop tumor cells from growing.~      PURPOSE: This phase I trial is studying how well cellular adoptive immunotherapy works in~     treating a patient who has undergone a donor stem cell transplant for breast cancer that has~     spread to the lung.~   "
248379|NCT00301691|"~     RATIONALE: Decreasing the amount of fat in the diet and increasing fruit and vegetable intake~     may help prevent some types of cancer. Giving low-income participants easy-to-read written~     nutrition materials and an instructional and motivational videotape may help improve eating~     habits.~      PURPOSE: This randomized clinical trial is studying how well nutrition education improves the~     eating habits of low-income healthy participants who eat an unhealthy diet.~   "
248380|NCT00301678|"~     RATIONALE: Decreasing the amount of fat in the diet and increasing fruit, vegetable, and~     fiber intake may help prevent some types of cancer. Giving participants easy-to-read~     personalized written nutrition materials and a personalized videotape may help improve eating~     habits.~      PURPOSE: This clinical trial is studying how well personalized nutrition education improves~     the eating habits of healthy participants who eat an unhealthy diet.~   "
248381|NCT00301665|"~     The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®)~     injections into pericranial muscles compared to placebo to prevent migraine attacks.~   "
248382|NCT00301652|"~     The purpose of this study is to access the efficacy of MMF compared to CTX in inducing~     remission and improving renal function in subjects with ANCA associated vasculitis with renal~     involvement.~   "
248383|NCT00301639|"~     The specific aim of this study is to document the pharmacokinetics of dopamine transporter~     DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane as~     the ligand. We hypothesize that CNS DAT occupancy of OROS MPH will be greater than that of~     Metadate CD at 10 hours after administration.~   "
248384|NCT00301626|"~     Background. The ROSCAP Study was a randomized controlled trial in heart disease patients to~     test the effect of a smoking reduction intervention on cigarettes per day (cpd) and~     biochemical and clinical indicators of tobacco exposure. .~   "
248385|NCT00301613|"~     This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs~     CTX in the treatment of severe HSPN~   "
248388|NCT00301574|"~     The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day~     and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment~     of patients with Alzheimer's disease, and to investigate the dose-response.~   "
248389|NCT00301561|"~     Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in~     immediate need in June 2005). Face to the scope of the need and the constraints~     (unavailability and cost of viral load and CD4 cell count, lack of physicians…), WHO has~     developed a follow-up approach based on a simplified monitoring. However, this simplified~     approach which represents a major stake for the expanded access to ART has been little~     evaluated against the gold standard approach.~   "
248390|NCT00301548|"~     The role of early timing of adjuvant chemotherapy was postulated to be particularly important~     for patients with endocrine non-responsive disease. The role of cytotoxicity during the~     period of breast surgery itself and immediately after (perioperative chemotherapy) remained~     unknown. We investigated in a randomized trial the role of perioperative chemotherapy in~     patients treated with a preoperative chemotherapy for locally advanced breast cancer and~     compare it to the preoperative chemotherapy without additional cytotoxic therapy during and~     immediately after definitive surgery. Patients with T2-3 N0-2 M0 breast cancer, with both~     estrogen receptors (ER) and progesterone receptors (PgR) expressed in less than 20% of tumor~     cells, or with absence of progesterone receptors, received up to 6 courses of primary~     systemic therapy with epirubicin 25 mg/m2 intravenously (i.v.) on days 1 and 2, cisplatin 60~     mg/m2 i.v. on day 1, and 5-fluorouracil 200 mg/m2 i.v. daily as continuous infusion (ECF).~     Patients achieving a partial or complete remission were randomized to continue the infusion~     of fluorouracil until 2 weeks after surgery (perioperative treatment arm) or to stop~     fluorouracil infusion one week before surgery, on day 21 of the sixth cycle (control arm).~   "
248391|NCT00301535|"~     The purpose of this study is to determine if Hemopure® will enhance tissue preservation~     during Cardiopulmonary Bypass surgery.~   "
248392|NCT00301522|"~     The primary objective of this study is to further evaluate the safety and effectiveness of~     the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and~     large vessel diameters and with multiple overlapping stents in the treatment of de novo~     coronary artery lesions~   "
248393|NCT00301509|"~     To evaluate:~        1. the impact of combined antiviral therapy (Peginterferon plus ribavirin) on natural~          history of patients affected with HCV decompensated cirrhosis, after sustained~          virological response. A controlled study.~        2. safety and efficacy of antiviral therapy in this population by using a statistically~          significally number of patients as controls.~   "
248394|NCT00301496|"~     The purpose of this study is to evaluate the product performance of a new 2-layer compression~     bandage for the treatment of venous leg ulcers.~   "
248395|NCT00301483|"~     The main purpose of this study is to determine if HBOC-201 is safe and tolerable to trauma~     subjects, when given to treat the inadequate supply of blood and nutrients to tissues and~     organs.~   "
248396|NCT00301470|"~     The objective of functional Uro MR is to add to an initial morphological phase, based on T2~     and T1 weighted MR sequences, a sequential contrast-enhanced acquisition allowing to obtain~     functional semi-quantitative parameters from time-intensity curves from ROIs placed on the~     aorta, renal parenchyma and cavities. If the equivalence with the renal scintigraphy is~     demonstrated, it would be possible to have both the morphological and functional approach of~     an obstructed kidney in one MR examination, without exposure to diagnostic irradiation.~   "
248397|NCT00301457|"~     The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve~     the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone~     sensitive breast cancer patients, subsequent to 2-3 years tamoxifen~   "
248398|NCT00301444|"~     The researchers propose to conduct a pilot study on the efficacy of mirror-box and mental~     visualization treatments on phantom limb pain. The trial will last for 4 months and during~     the first month, data will be gathered daily on the number of episodes of phantom limb pain,~     the average length of episodes, average intensity of pain, and worst intensity of pain. In~     addition, the rapidity of pain relief, the length of therapy needed to sustain long-lasting~     pain relief, and whether use of these two treatment methods during rehabilitation can provide~     sustained and/or permanent pain relief will be determined. Cognitive testing will also be~     performed to determine the effect of limb amputation on cognition and mood with results being~     compared to an on-going study of similar effects in patients with chronic (> 3 months) limb~     amputation.~      The inclusion of subjects with phantom limb pain in upper extremity amputations has recently~     been approved.~   "
248399|NCT00301431|"~     The purpose of this study is to determine if DVS-233 is safe and effective in the treatment~     of pain and other symptoms of fibromyalgia syndrome.~   "
248400|NCT00301418|"~     This study will offer a safe treatment for patients with relapsing recurring glioblastoma~     (GBM) or anaplastic astrocytoma (AA). The trial will test the hypothesis that Erlotinib~     (Tarceva, OSI-774) can be safely used up to a dose of 150 mg two times a day for 12 months to~     ultimately enhance survival of patients with relapsed/refractory GBM/AA. Correlation of~     response to Tarceva with particular genetic alterations including epidermal growth factor~     receptor variant type III (EGFRvIII) amplification and phosphatase and tensin homolog~     (mutated in multiple advanced cancers 1) (PTEN) loss will be studied.~   "
248401|NCT00301405|"~     To determine the efficacy of thalidomide for treatment of the Chronic Pelvic Pain Syndrome~     (CPPS).~   "
248402|NCT00301392|"~     The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes~     in a population with impaired glucose tolerance.~   "
248403|NCT00301379|"~     This is an observational study intended to validate results of a previous study done at the~     Mayo Clinic. Patients are treated with combination chemotherapy and radiation and maintained~     on oral Xeloda until they can receive liver transplant. A staging laparotomy is performed~     before chemoradiation in order to identify patients who will most benefit from the treatment~     and to improve outcomes.~   "
248404|NCT00301366|"~     The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in~     adult Alpha1-antitrypsin deficient patients.~   "
248662|NCT00297947|"~     This study will investigate the safety and efficacy of quetiapine in sub-optimally responding~     patients with DSM-IV schizophrenia using a double blind, randomized 12-week trial comparing~     oral doses of 1200 mg/d to 600 mg/d of quetiapine.~   "
248405|NCT00301353|"~     Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing~     products may be a potential alternative to HRT for preventing bone loss during the menopausal~     transition. We investigated whether one-year consumption of isoflavone-enriched foods~     affected bone mineral density, bone metabolism and hormonal status in early postmenopausal~     women in a randomized double-blind, placebo controlled parallel multi-centre trial.~   "
248406|NCT00301340|"~     Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator~     (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore~     causing a quick-acting suffocation that will not result in the development of resistance.~      The objectives of this open label study are to evaluate the efficacy and safety of home use~     of two 10-minute treatments of 5% L.A. (applied one week apart).~   "
248407|NCT00301327|"~     This is a multi-center, randomized, double blind, vehicle controlled, study designed to~     evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.~   "
248408|NCT00301314|"~     The majority of patients with Hodgkin Lymphoma (HL)are cured with radiation therapy and/or~     combination chemotherapy. However, patients who relapse after attaining a complete remission~     with chemotherapy and those with primary refractory disease have a poor outcome with~     conventional chemotherapy regimens. Treatment results with standard−dose second−line regimens~     produce low complete remission rates and minimal survival benefit. Single institution studies~     have shown better outcome after autologous stem cell transplant in this group of patients~     when compared to historical controls receiving conventional treatment. In this retrospective~     review, we aim to analyze outcome and determine independent prognostic factors which would~     correlate with the long−term outcome of patients with HL who received an autologous stem cell~     transplant in the past at the Royal Marsden Hospital Eligible patients (those on~     current−follow−up) identified from the transplant database will be eligible for the study.~      Accrual of eligible patients currently under follow−up will be performed in clinic at the~     time of next appointment. All patients accrued will give informed consent to participate in~     the study for retrospective case note review, after discussion with a study investigator and~     after receiving a study information sheet. The results of the analysis will be published in a~     peer−reviewed medical journal.~   "
248409|NCT00301301|"~     There has been considerable international /national interest in the GEM−P regimen for~     treatment of patients with relapsed/refractory lymphoma. Currently, there is no accepted~     standard therapy for these patients. Since the publication of our experience with this~     regimen (Study with CCR ethics number 1857 closed to recruitment in July 2003:Ng M, Waters J,~     Cunningham D et al, Br J Cancer 2005;92:1352−7), we have treated relapsed/refractory lymphoma~     patients with this regimen and would like to undertake a retrospective review of a sub−group~     of these patients with diffuse large B cell lymphoma (DLBCL).~      Patients treated with GEM−P with or without Rituximab prior to March 2005 for~     refractory/relapsed DLBCL will be included in the analysis. Accrual of eligible patients~     currently under follow−up will be performed in clinic at the time of next appointment.~      All patients accrued will give informed consent for retrospective case note review, after~     discussion with a study investigator and after receiving a study information sheet. All~     eligible patients identified from the pharmacy database, and will be consented at the time of~     the next clinic appointment, if they are agreeable for the retrospective case note review.~   "
248410|NCT00301288|"~     Patients with aggressive Non−Hodgkin−lymphoma treated at first diagnosis with chemotherapy~     alone or combined chemo-radiotherapy can achieve high response rates. However, patients with~     relapsed lymphoma still have a poor prognosis. High dose chemotherapy (HDCT) followed by~     autologous stem cell transplantation (ASCT) is the treatment of choice for these patients. An~     ASCT allows patients to receive much higher doses of chemotherapy than usual, to improve the~     chances of curing the disease. The high−dose of chemotherapy destroys the cells in the~     patients bone marrow and then the patients own cells from either the bone marrow or~     peripheral blood are used to rescue the patient from intensive treatment. High−dose~     chemotherapy with autologous stem cell (either bone marrow or peripheral blood)~     transplantation is used in the treatment of Intermediate/High grade NHL with poor risk~     disease and in second remission at the Royal Marsden Hospital.~      The purpose of the present analysis is to determine independent prognostic factors correlated~     with the long−term outcome of patients with NHL who received an ASCT between January 1991 and~     June 2005. Accrual of eligible patients currently under follow−up will be performed in clinic~     at the time of next appointment. All patients accrued will give informed consent to~     participate in the study for retrospective case note review, after discussion with a study~     investigator and after receiving a study information sheet. The results of the analysis will~     be published in a peer−reviewed medical journal. This will include patients treated at the~     royal Marsden Hospital only.~   "
248411|NCT00301275|"~     Multiple myeloma is a disorder in which malignant plasma cells accumulate in the bone marrow.~     These plasma cells produce an abnormal protein called paraprotein / M spike in the serum~     which can be serially monitored to assess the response of tumour on therapy. The paraprotein~     has a heavy chain which can be either IgG, IgA, IgM or IgD and a light chain which can be~     either kappa or lambda.~      At present, these can be assessed by serum and urine electrophoresis (SPE and UPE). These~     techniques are relatively insensitive and poorly quantitative compared with other~     immunoassays for tumour markers.~      The potential of serum free light chain (flc) measurement as a marker for myeloma has been~     recognised for some time. However, development of such assays has proved elusive, primarily~     due to the difficulty in developing assays that are both convenient to use and have the~     required specificity to measure flc in serum. Recently , the assay has been standardised and~     is in use. Its likely that the assessment of flc might be a sensitive marker of documenting~     complete remission in patients with myeloma. The aim of this study is to study the flc in~     patients with myeloma in complete remission (CR) to see if patients have CR documented by~     standard criteria- are the free light chains still positive and if so are they better markers~     of remission. The samples will be collected and tested in batches of 60 each.~   "
248412|NCT00301262|"~     Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the~     same extent as it is by moderate and severe ED. This study will provide controlled clinical~     data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated~     with Viagra versus those treated with a placebo. With an open-label extension, this study~     will also provide all study subjects the opportunity to receive the active drug treatment for~     6 weeks.~   "
248413|NCT00301249|"~     The Family Investigation of Nephropathy and Diabetes (FIND)Study is a multi-center~     consortium. The charge of the consortium is to acquire sets of families with~     well-characterized diabetic nephropathy, establish a secure master FIND database, and perform~     a genome scan to identify chromosomal regions linked with diabetic nephropathy.~   "
248414|NCT00301236|"~     The purpose of this study is to determine which dosages of dexmethylphenidate HCl~     extended-release capsules may represent effective treatment for ADHD in children 6-12 years~     of age.~   "
248415|NCT00301223|"~     The objective of this study is to evaluate the efficacy, safety and tolerability for~     pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the~     symptoms of neuropathic pain.~   "
248416|NCT00301210|"~     Opioids are one of the most commonly abused drugs among individuals who seek treatment for~     drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose~     of this trial is determine whether tramadol is effective in treating opioid dependent~     individuals.~   "
248417|NCT00301197|"~     Obesity is a major public health problem. At least 15 million American adults are obese, and~     the number is rising. Childhood obesity is also increasing in prevalence and currently~     affects approximately 11-22 percent of children aged 6 to 11. Childhood obesity is associated~     with serious negative physical, emotional, and social consequences. Obese children are at~     high risk for becoming obese as adults; 24-44 percent of obese adults were obese as children.~     The risk of an obese child becoming an obese adult is especially high when at least one~     parent is obese. To date, adult obesity is known to be resistant to treatment. In contrast,~     promising long-term effects have been found with children who received behavioral~     family-based weight loss treatment. However, even with state-of-the-science programs, a~     substantial percentage of children (i.e., over 40 percent) regain all or most of the weight~     lost once treatment ends. The proposed study examined the efficacy of two intervention~     strategies designed to improve the long-term maintenance of weight loss in children relative~     to discontinued treatment contact following an active weight loss treatment phase (no~     maintenance treatment control (NTC).~   "
248418|NCT00301184|"~     The purpose of this study is to determine the safety of and immune response to a DNA HIV~     vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV~     uninfected adults.~   "
248419|NCT00301171|"~     Wheezing is a high-pitched whistling sound that is produced when air flows through narrowed~     lung airways. It is a common symptom of asthma. Persistent wheezing is commonly treated with~     bronchodilators and inhaled steroids; however, when wheezing is temporarily caused by a virus~     or exposure to tobacco smoke, this may not be the most effective treatment. The purpose of~     this study is to evaluate the cause of wheezing in infants and children and to assess the~     effectiveness of inhaled steroids on improving lung function.~   "
248420|NCT00301158|"~     RATIONALE: Physical activity may lower the risk of some types of cancer and other chronic~     diseases.~      PURPOSE: This clinical trial is studying ways to increase physical activity in urban~     adolescents who attend after-school programs.~   "
248421|NCT00301145|"~     RATIONALE: Varenicline tartrate may help people quit smoking by decreasing the symptoms of~     nicotine withdrawal. It is not yet known whether varenicline tartrate is more effective in~     helping people stop smoking when given together with a telephone-based counseling program,~     and Internet-based counseling program, or both programs.~      PURPOSE: This randomized clinical trial is studying how well giving varenicline tartrate~     together with a telephone-based counseling program and/or an Internet-based counseling~     program works in helping adults stop smoking.~   "
248422|NCT00301119|"~     RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and~     plan effective treatment for lung cancer.~      PURPOSE: This clinical trial is studying biomarkers in screening participants for lung~     cancer.~   "
248423|NCT00301106|"~     RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may~     help the body build an effective immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified~     virus that can make interleukin-12 in treating women with breast cancer that has spread to~     the liver.~   "
248424|NCT00301093|"~     RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective~     immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with~     imatinib mesylate may be an effective treatment for chronic myelogenous leukemia.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy~     when given together with imatinib mesylate in treating patients with chronic phase chronic~     myelogenous leukemia.~   "
248425|NCT00301080|"~     D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by~     chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in~     treating peripheral neuropathy caused by chemotherapy.~      This randomized, double-blind, placebo-controlled clinical trial was designed to study~     D-cycloserine at 2 different doses to see how well each works compared to the other and to a~     placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.~   "
248426|NCT00301067|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the~     drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor.~      PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of~     calcitriol when given together with temozolomide, and to see how well they work in treating~     patients with metastatic stage IV melanoma.~   "
248427|NCT00301054|"~     A study that seeks to establish an effective way of preventing anaemia in children at the~     community level using two known interventions - Iron supplementation and or antimalarial.~     Children recruited into the study will be assigned to four groups. Those receiving Placebo~     and Iron, those receiving Placebo and Antimalarial, those receiving Placebo and Antimalarial~     and those receiving double placebo. The children will be followed up over a period of nine~     months and their haemoglobin concentration, malaria parasites in their blood and their weight~     and height will be assessed.~   "
248663|NCT00297934|"~     The purposes of this study is to determined the effects of instrument applied spinal~     manipulative therapy upon dual-task performance involving complex postural and cognitive~     task.~   "
248428|NCT00301041|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy in different ways may kill more tumor cells.~      PURPOSE: This randomized clinical trial is studying the side effects and best way to give~     radiation therapy and to see how well it works in treating patients with invasive breast~     cancer.~   "
248429|NCT00301028|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others~     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,~     such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving more than~     one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses~     high-energy x-rays and other types of radiation to kill tumor cells. Giving cetuximab~     together with combination chemotherapy and radiation therapy, with or without cisplatin, may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin~     and paclitaxel followed by radiation therapy, with or without cisplatin, works in treating~     patients with metastatic head and neck cancer.~   "
248430|NCT00301015|"~     The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck~     Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health~     workers at village level in Tanzania and how the use of rapid diagnostic test may influence~     prescription of antimalarial drugs.~      The hypothesis is that rapid diagnostic tests used by community health workers will reduce~     the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health~     outcome.~   "
248431|NCT00301002|"~     The purpose of this study is to determine if Alefacept is effective in the treatment of~     palmar plantar pustulosis.~   "
248432|NCT00300989|"~     The purpose of the investigation is to compare post-operative fracture and wound healing~     using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.~   "
248433|NCT00300976|"~     (Intervention study) The objective of the study is to confirm the superiority of the~     intensive therapy to the conventional therapy concerning the prevention of the incidence or~     exacerbation of vascular complications caused by diabetes mellitus (DM) by a randomized~     controlled study in patients with type 2 DM.~      (Follow-up study) The objective of the follow-up study is to evaluate the long-term efficacy~     of intensive versus conventional therapy in the effect on mortality and the prevention of the~     incidence or exacerbation of vascular complications caused by diabetes mellitus through a~     post-intervention follow-up research conducted after the multi-center, open-label, randomized~     parallel-group study comparing the efficacy of intensive versus conventional therapy in type~     2 diabetic patients.~   "
248434|NCT00300963|"~     The purpose of this study is to test the safety and effectiveness of talnetant vs.~     risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic~     schizophrenia patients.~   "
248435|NCT00300950|"~     The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection,~     non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as~     safety, and immune responses related to the injections.~   "
248436|NCT00300937|"~     As preeclampsia is a disease specially affecting young and primiparous women, and due to the~     fact that we found previously in several studies a prevalence of 12%, to ensure a confidence~     of 95% and a power of 80%, it is necessary to include a total of 190 women (95 in each arm),~     therefore it is planned to recluse a total of 200 pregnant women currently attending to the~     outpatients clinic at the HGOIA for pregnancy control before than week 20 of gestation.~      From each one of those women the clinical research team will obtain an obstetric,~     anthropometric and clinical record following the current regulations of the Ecuadorian Public~     Health Ministry. All women included will be under a detailed prenatal control every 4 weeks~     from week 20 of pregnancy, this will include gestational age, weight, umbilical perimeter,~     uterine altitude, fetal cardiac frequency and maternal blood pressure.~      In addition, in each schedule visit an urine test will be done (to discard proteinuria), also~     a venous blood sample (10 ml) in heparinized tubes will be taken and immediately transported~     to the Biomedical Center for centrifugation and plasma isolation. During week 20, all women~     will be assigned (using a randomized numbers table) to one of the following groups: a)~     intervention group, that will received two capsules of 100 mg of coenzyme Q10 twice daily up~     to delivery; or b) control group, that will receive two capsules of the correspondent placebo~     twice daily up to delivery. Both, active and placebo capsules will be manufactured by the~     same provider (Jarrow Formulas, Los Angeles, CA, USA) to guarantee that weight, size, odor~     and color are similar.~      Absolutely all women participating in the study will know all contact information of the~     clinical team and will be allowed to request medical care as frequent as they needed,~     independently of establish obstetrical controls. Preeclampsia diagnosis will be performed~     only by clinical researchers and based on a persistent high blood pressure higher than 140/90~     mmHg and proteinuria higher than 300 mg/24 hours.~      Coenzyme Q10 will be measured using a high performance liquid chromatography equipment (HPLC)~     and the method previously described and validated by our group.~      The hypothesis is that in the group receiving CoQ10 supplementation will be less cases of~     preeclampsia compared to placebo.~   "
248437|NCT00300924|"~     The purpose of this study is to test an experimental drug combination of two medications~     currently approved by the Food and Drug Administration (FDA) for migraine headache or other~     pain. These are called rizatriptan given with acetaminophen.~   "
248438|NCT00300911|"~     The present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function~     compared with metformin~   "
248439|NCT00300898|"~     The purpose of this study is to learn which of three minimally invasive procedures is the~     most effective for treatment of contained lumbar disc herniation.~   "
248440|NCT00300885|"~     A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel~     plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.~   "
248466|NCT00300547|"~     The purpose of this study is to diagnose possible synchronous carcinomas and polyps with~     magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in~     the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two~     days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day,~     which will render fecal masses invisible on the following MR colonography. The study is~     primarily a feasibility study with altered operative strategy as a secondary end-point. Gold~     standard is colonoscopy and operation.~   "
248467|NCT00300534|"~     The performance of an investigational immunochromatographic strip (ICS) test for the~     diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study~     population consists of patients with and without syphilis presenting to sexually transmitted~     disease clinics in five cities in the United States. Specimens include finger-stick whole~     blood (investigational test only) and whole blood, plasma, and serum by venipuncture.~   "
248441|NCT00300872|"~     Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5~     times per hour. SDB is a common disorder affecting 9 to 24% of the middle-aged and overall 4%~     of the middle-aged male population suffers from the Obstructive sleep apnea syndrome (OSA)~     i.e. Sleep-disordered breathing (SDB) with associated daytime sleepiness. Several major~     epidemiological studies have shown that SDB is not only an independent risk factor for~     hypertension but it is also strongly associated with heart failure and stroke. The mechanism~     for the linkage between SDB and cardiovascular consequences is not fully determined. Vascular~     endothelial growth factor (VEGF) is a soluble 34-46 kD angiogenic heparin-binding~     glycoprotein. This cytokine regulates multiple endothelial cell functions including vascular~     permeability and vascular tone and some data suggest that it may contribute to the~     atherosclerotic process. Recent studies have shown increased plasma and serum concentrations~     of Vascular endothelial growth factor (VEGF) in patients with OSA and there were correlations~     between VEGF concentrations and the severity of OSA, as indexed by the minimum oxygen~     saturation level and the frequency of the upper airway obstruction per hour of sleep. A~     recent non-randomized study with a small sample size has shown a significant decrease in~     Vascular endothelial growth factor (VEGF) concentrations in patients in whom nocturnal~     hypoxia improved after 1 year of nasal continuous positive airway pressure (CPAP) therapy.~      Despite robust evidence showing improvement of symptoms, cognitive function and quality of~     life in obstructive sleep apnea (OSA) patients treated with nasal CPAP, there are~     nevertheless conflicting data whether Continuous positive airway pressure (CPAP) can reduce~     daytime blood pressure (BP) in patients with OSA. Two randomized placebo controlled studies~     have shown reduction of 24-hr systolic and diastolic blood pressure (BP) in obstructive sleep~     apnea (OSA) patients after 1 month of nasal continuous positive airway pressure (CPAP)~     therapy while other investigators have shown no such benefit.~      This randomized, sham-placebo controlled study aims to assess 1) the effect of nasal~     continuous positive airway pressure (CPAP) over a period of 3 months on 24 hr blood pressure~     (BP); and 2) whether any change in BP and plasma Vascular endothelial growth factor (VEGF) is~     related to the baseline severity of obstructive sleep apnea (OSA) and continuous positive~     airway pressure (CPAP) compliance.~   "
248442|NCT00300859|"~     DESCRIPTION (adapted from applicant's abstract): Injury control experts suggest that~     consistent SBU is the most effective means for motorists to reduce1he risk of death or~     serious injury in a crash. Sadly, the SBU prevalence among Massachusetts' residents is among~     the lowest in the nation. In accord with Healthy People 2010, Objective 15-19, and the CDC's~     Injury Research Agenda, the investigator will test the utility of a brief intervention to~     increase SBU among ED patients with self-reported SBU that IS less than always. A secondary~     aim is to determine if the brief intervention is more effective among persons being treated~     for a motor vehicle crash (MVC)-related injury during a teachable moment than other~     non-injured ED patients receiving the same intervention. The research staff will~     systematically sample ED patients, screening for SBU among eligible participants during a~     3-month period. Upon obtaining verbal consent, researchers will ask participants to complete~     a self-administered screening form on health and safety issues, including SBU. Patients that~     screen positive, (i.e., give an answer of less than always use safety belts) on a SBU~     screening question will be asked to participate in an intervention to promote health and~     safety among ED patients. Participants will be reimbursed for their time, and asked to do the~     following: to give written informed consent via IRB-approved forms and a HIPAA release form;~     complete an intake form, and agree to a follow-up phone interview at 3 and 6 months~     post-enrollment. Participants will be randomized into one of two groups: an Intervention~     Group that will receive a brief intervention designed to increase SBU, and a Control Group~     that will receive only standard care. Research staff will contact participants for a~     follow-up phone survey at 3 and 6 months to test the hypothesis that individuals randomized~     to the Intervention Group will have a higher self-reported SBU than those in the Control~     Group that received only standard care. Likewise, for the secondary (exploratory) analysis,~     the hypothesis is that among those treated for MVC-related trauma--and randomized to the~     intervention group--will have a higher self-reported SBU than others with non MVC-related~     trauma due to a greater receptivity to brief intervention techniques during the ED visit~     (i.e. the teachable moment).~   "
248443|NCT00300846|"~     The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy~     of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who~     are not optimally controlled on clozapine.~   "
248444|NCT00300833|"~     Treating an AMI patient with ST elevation with Aggrastat in the ambulance on his or her way~     to the hospital.~   "
248445|NCT00300820|"~     This study will examine those who will seek and those who are most likely to benefit from~     genetic counseling for psychiatric disorders. It will identify themes related to perceived~     risks, benefits, and possible motivations for seeking genetic counseling among families~     affected by bipolar disorder. It will then use those themes to generate a starting point for~     a framework to guide further research and to improve genetics services as they are currently~     practiced.~      Adults with bipolar disorder and the adult siblings of people with bipolar disorder are~     eligible for this study. In a 60- to 90-minute telephone interview, participants are asked~     questions related to their thoughts about the causes of bipolar disorder, their experiences~     with the illness, their concerns about the disorder occurring again in their families, and~     their feelings about the value of discussing these issues with health care professionals.~     They also are asked questions about the mental health of their close family members and their~     own mental health.~   "
248446|NCT00300807|"~     1. Evaluate the safety, tolerability, and virologic activity of escalating single (and~          multiple) doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies~          (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection.~        2. Assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection.~   "
248447|NCT00300794|"~     The purpose of this study is to determine whether low-dose ketamine infusion is effective in~     suppressing the symptoms of opiate withdrawal during rapid opiate antagonist induction (RAI).~   "
248448|NCT00300781|"~     The purpose of this study is to learn whether neratinib is safe and effective in treating~     women with advanced HER2+ (human epidermal growth factor 2) breast cancer.~   "
248449|NCT00300768|"~     The primary purpose of this study is to determine the safety and tolerability of moxidectin~     in subjects infected with O. volvulus with special emphasis on Mazzotti reactions to~     determine whether it is safe enough to expose a number of subjects sufficient for obtaining~     statistically significant data on the safety and efficacy of moxidectin relative to~     ivermectin.~      Secondary objects are to determine the pharmacokinetics of moxidectin, to obtain initial~     indication of the efficacy in terms of long term effect on skin microfilaria levels and an~     indication of the effect on the macrofilaria that may underlie the effect on skin~     microfilaria levels.~   "
248450|NCT00300755|"~     To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5~     years of age with endoscopically proven symptomatic GERD.~   "
248451|NCT00300742|"~     The purpose of this study is to test the feasibility of using topiramate to reduce binge~     eating and drinking episodes in alcohol dependent individuals with comorbid binge eating~     disorder.~   "
248452|NCT00300729|"~     The primary purpose of the study is to investigate if daily treatment with celecoxib, an~     inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell~     lung cancer who receive anticancer chemotherapy as their primary treatment. Secondary~     endpoints of the study are: health-related quality of life, toxicity, cardiovascular events,~     progression-free survival, and biological markers (VEGF, proteomics).~   "
248453|NCT00300716|"~     This study is designed to determine whether memantine is an effective treatment for memory~     and cognitive problems associated with multiple sclerosis when compared to placebo.~   "
248454|NCT00300703|"~     To provide the infrastructure to answer prehospital research questions posed by scientists at~     academic health science centers and policy makers at multiple levels of government.~   "
248457|NCT00300664|"~     About 90% of patients with haemato-oncologic malignancy lose their body muscle mass and also~     lose weight either due to chemotherapy induced nausea/vomiting or the high catabolic state~     due to fever, sepsis or chemotherapy. This impacts tremendously on the days in hospital and~     also on the treatment-related complications. Studies with Human Growth hormone (hGH) have~     shown that it increases lean body mass in adult patients with AIDS and animal models of~     cancer. At the same time, in vitro studies have shown that hGH has no effect on tumor cell~     growth. This study is designed to see if the use of hGH in immunocompromised patients with~     haematological malignancies prevents the loss of muscle mass and weight loss to some extent.~      This will be a blinded 1:1, randomised study including 150 patients whereby the patients will~     either receive hGH or a placebo. The doctors and the nurses will not know what drug the~     patient is receiving. Both hGH and the placebo will be given intravenously (if patients are~     receiving other intravenous antibiotics or haemopoietic support ) or subcutaneously (if~     platelets are above 20 x 109/L) The treatment will start on the first day of treatment and~     continue for 6 weeks.~   "
248458|NCT00300651|"~     The following study addresses the hypothesis that cognitive-behavioral interventions will be~     effective in reducing positive and negative symptoms of schizophrenia under the conditions of~     the German health care system. It is also hypothesized that interventions designed to reduce~     delusions will reduce cognitive biases and dysfunctional self-concepts.~   "
248459|NCT00300638|"~     The purpose of this study is to determine whether long-term chronic alcoholism is associated~     with changes in emotional functioning and brain structure and function.~   "
248460|NCT00300625|"~     This study was designed to validate the San Francisco Syncope Rule. This set of rules was~     derived by Quinn et. al. to help guide the treatment of patients evaluated in the Emergency~     Department who had an episode of syncope (passed out) or near syncope (almost passed out). A~     rule that considers patients with an abnormal ECG, a complaint of shortness of breath,~     hematocrit less than 30%, systolic blood pressure less than 90 mm Hg, or a history of~     congestive heart failure was shown predict with a good degree of accuracy which patients~     would have an adverse event and require admission.~   "
248461|NCT00300612|"~     This 2-phase study will determine the safety of treating patients with malignant melanoma~     with the genetically engineered HyperAcute-Melanoma vaccine. It will establish the proper~     vaccine dose and will examine side effects and potential benefits of the treatment. The~     vaccine contains killed melanoma cells containing a mouse gene that causes the production of~     a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response~     to the foreign substance will stimulate the immune system to attack the patient's own cancer~     cells that have similar proteins without this sugar pattern, causing the tumor to remain~     stable or shrink.~      Patients 18 years of age or older with malignant melanoma may be eligible for this study.~     Candidates will be screened with medical history and physical examination, blood tests,~     urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if~     needed.~      Participants will receive twelve vaccinations two weeks apart from each other. The vaccines~     will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase~     I of the study will treat successive groups of patients with increasing numbers of the~     vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase~     II will look for any beneficial effects of the vaccine given at the highest dose found to be~     safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine~     treatment. In addition, patient follow-up visits will be scheduled every 3 months for the~     remaining first year (6 months) after vaccination and then every 6 months for the next 2~     years for the following tests and procedures to evaluate treatment response and side effects:~      Medical history and physical examination Blood tests X-rays and various scans (nuclear~     medicine/CT/MRI) FACT-G Assessment questionnaire to measure the impact of treatment on the~     patient's general well-being. The questionnaire is administered before beginning treatment,~     monthly during treatment, and during follow-up visits after completing the treatment. It~     includes questions on the severity of cancer symptoms and the ability to perform normal~     activities of daily life.~   "
248462|NCT00300599|"~     Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5~     times per hour. Sleep-disordered breathing affects 9 to 24% of the middle-aged and overall 4%~     of the middle-aged males suffers from Obstructive sleep apnea syndrome (OSAS) i.e. SDB with~     associated daytime sleepiness. Several major epidemiological studies have shown that SDB is~     not only an independent risk factor for systemic hypertension but it is also associated with~     cardiovascular complications such as heart failure, stroke, and sudden death.~      The mechanisms for the linkage between Sleep-disordered breathing and cardiovascular diseases~     are not fully determined but surges in sympathetic nerve activity are seen at the end of each~     apneic episode accompanied by large rises in systemic arterial blood pressure (BP). The~     increased levels of muscle sympathetic nerve activity are diminished by nasal continuous~     positive airway pressure (CPAP) therapy. Numerous studies have found a hypercoagulable state~     in terms of increased clotting factor and platelet activities, and impaired fibrinolysis in~     coronary artery disease, ischaemic stroke, and sleep-disordered breathing. Common carotid~     artery intima-media thickness (IMT) has been shown to correlate with traditional vascular~     risk factors and may predict the likelihood of acute coronary events and stroke. Recently,~     carotid artery intima-media thickness has been shown to have positive correlations with the~     severity of sleep disordered breathing.~      Despite robust evidence showing improvement of symptoms, cognitive function and quality of~     life in patients with obstructive sleep apnea treated with nasal continuous positive airway~     pressure, there are conflicting short-term data whether continuous positive airway pressure~     can reduce blood pressure in patients with obstructive sleep apnea. This randomized~     controlled study aims to assess the long-term effects of nasal continuous positive airway~     pressure on 1) 24 hr systemic blood pressure; 2) Coagulation state; and 3) Carotid artery~     intimal media thickness.~   "
248463|NCT00300586|"~     The objective of this trial is to improve the duration of control disease for PS 0-1 patients~     who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is~     for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a~     second-line chemotherapy when progression of disease is occurring. Two approaches will be~     experimented in this trial in attempt to prolong progression free survival :~        -  Maintenance chemotherapy with single-agent gemcitabine continued till disease~          progression or toxicity.~        -  Sequential treatment with erlotinib immediately given after the end of first-line~          chemotherapy.~   "
248464|NCT00300573|"~     The study will compare the safety and efficacy of an investigation nucleoside analog reverse~     transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC)~     in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral~     therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new~     'optimized' background regimen (OBR) selected for them by their investigator based on prior~     ARV treatment history and the results of HIV genotype and phenotype tests performed during~     the screening period. In addition to treatment with the new OBR, patients will be randomized~     to receive treatment with either DFC or 3TC in a blinded fashion. There is a 50 percent~     chance a patient will receive DFC or 3TC. Treatment in the study may continue for up to 96~     weeks. Patients with an inadequate response to therapy after 16 weeks will have the option to~     change their OBR and the option to switch to receive the other study medication (i.e., DFC to~     3TC or 3TC to DFC).~   "
248465|NCT00300560|"~     In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated~     to receive colistin or conventional antibiotic regimen.~   "
248512|NCT00299936|"~     The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of~     rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects~   "
248468|NCT00300521|"~     Previous rather poor results in liver transplantation (LT) of patients with advanced~     hepatocellular carcinoma (HCC) have made the application of LT very limited in treatment of~     HCC. The advantages of ADV-TK gene therapy highlight its potentiality as adjuvant treatment~     for HCC patients after LT. We reported here the improved outcome of LT with combined~     treatment of ADV-TK gene therapy in patients with intermediate or advanced HCC.~   "
248469|NCT00300508|"~     The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an~     untreated control group after initial 5 years of adjuvant hormone-therapy.~   "
248470|NCT00300495|"~     Atrial fibrillation is a very common complication of pulmonary resection. Patients who~     develop atrial fibrillation require additional treatment and are more likely to stay in the~     hospital for longer period of time increasing the costs associated with the operation. We~     propose a randomized controlled trial to see if oral amiodarone given for one week before~     surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the~     incidence of atrial fibrillation in patients who received preoperative amiodarone and compare~     them to the incidence of atrial fibrillation in patients who did not received preoperative~     amiodarone.~   "
248471|NCT00300482|"~     The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)~     + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy~     in subjects with multiple abnormal lipid levels in the blood.~   "
248472|NCT00300469|"~     The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)~     + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with~     multiple abnormal lipid levels in the blood.~   "
248473|NCT00300456|"~     The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)~     + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with~     multiple abnormal lipid levels in the blood.~   "
248474|NCT00300443|"~     The purpose of this study is to assess the safety and efficacy of bimatoprost in patients~     with glaucoma or ocular hypertension~   "
248475|NCT00300430|"~     The primary purpose of this study is to test the safety and the effects of using an~     investigational drug regimen; once daily ABT-335 (Investigational drug) administered in~     combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in~     patients with abnormal lipid levels in the blood.~   "
248476|NCT00300417|"~     This study will test the safety of an experimental vaccine for preventing West Nile virus~     infection. The virus is spread mainly by mosquito bites. Symptoms can include high fever,~     headache, neck stiffness, stupor, muscle weakness, vision loss, numbness and paralysis.~     Rarely, infection leads to permanent nerve damage and possibly death. The vaccine used in the~     study is made from DNA that codes for West Nile virus proteins. Injected into a muscle, the~     DNA instructs the body to make a small amount of West Nile virus protein. This study will see~     if the body creates resistance or immunity to these proteins. Participants cannot get West~     Nile virus from the vaccine.~      Healthy normal volunteers between 18 and 65 years of age may be eligible for this study.~     Candidates are screened with a medical history, physical examination, and blood and urine~     tests for various infections and other medical problems. Women who are able to become~     pregnant are given a pregnancy test. Women who are pregnant or breastfeeding may not~     participate. Anyone who has received a vaccination for Yellow Fever or Japanese Encephalitis~     virus in the past may not participate in this research study.~      Participants will receive three injections of the experimental vaccine, the first on the~     first study day (Day 0), the second on Day 28, and the third on Day 56. The injections are~     given with a device called Biojector® (Registered Trademark) 2000 that delivers the vaccine~     through the skin into the muscle without the use of a needle. On the day of each injection,~     subjects are given a diary card to take home for recording their temperature and any symptoms~     or side effects for 5 days. They return to the clinic 2 weeks after each injection, bringing~     the completed card with them at that time. In addition to the injections, subjects have the~     following tests and procedures during clinic visits:~        -  Medical history and, if needed, physical examination: Day 0 and weeks 2, 4, 6, 8, 10,~          12, 24 and 32~        -  Vital signs and weight: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32~        -  Lymph node exam: Day 0 and weeks 2, 4, 6, 8, 10, and 12~        -  Blood samples: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32~        -  Pregnancy test (for women): Day 0 and weeks 4, 8 and 32~        -  Urine sample: Day 0 and weeks 2, 4, 6, 8, and 10~      The blood and urine tests are for health checks. Some blood samples are also used to study~     the immune response to the vaccine and for gene testing.~   "
248477|NCT00300404|"~     We investigate whether the add-on specific antitoxoplasmatic medication has positive effects~     in individuals with schizophrenia or major depression seropositive for Toxoplasma gondii (TG)~     infection. As TG modulates neurotransmitter metabolism affecting serotonin and dopamine we~     hypothesize that this chronic persistent infection might play a role for depressive and~     psychotic symptomatology. Therefore, on the basis of an ex juvantibus approach, specific anti~     TG medication might further improve psychiatric symptomatology in affected patients. This is~     investigated in a double-blind, placebo-controlled, randomized treatment trial.~   "
248478|NCT00300391|"~     The purpose of this study is to determine if treating delirious intensive care unit patients~     with haloperidol improves mortality.~   "
248479|NCT00300378|"~     The primary objective is to compare the antidepressant efficacy, safety, and tolerability of~     DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives~     include testing both general and functional quality-of-life outcomes and satisfaction with~     therapy reported by the subject.~   "
248480|NCT00300365|"~     We will test our primary hypothesis that combining niacin extended release (niacin-ER), at a~     daily dosage of up to 2.0 g with pioglitazone, at a daily dosage of 45 mg will result in a~     12% greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in~     non-diabetic patients with the metabolic syndrome (see Table 1).~   "
248481|NCT00300352|"~     We seek to examine the effects of folic acid treatment on vascular function in patients with~     coronary artery disease. Our hypothesis is that folic acid treatment will improve vascular~     function~   "
248482|NCT00300339|"~     To investigate in patients suffering from intermittent claudication due to Fontaine stage II~     PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an~     improvement of walking capacity, by comparing three doses of SL650472 to placebo, and to~     calibrate such effect versus cilostazol~   "
248483|NCT00300326|"~     To determine clinical outcomes and biomechanical gait performance of patients who receive the~     Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. This study~     will provide evidence as to whether there are differences between the two surgical procedures~     with respect to complications such as infection and dislocations, rate and level of~     functional recovery, blood loss, operating time, degree of radiographic correction and~     quality and duration of post-operative pain and stiffness.~   "
248484|NCT00300313|"~     Assessing the efficacy of escitalopram in preventing the development of PTSD, or or reducing~     its severeness, after exposure to a traumatic event.~   "
248554|NCT00299390|"~     The purpose of this study is to determine whether the study drug is effective and safe in the~     first line treatment of patients with small cell lung cancer~   "
248485|NCT00300300|"~     ACL reconstruction in the Division of Orthopaedic surgery at Queen's is currently being~     performed arthroscopically assisted. The resultant function of the reconstructed ligament is~     greatly influenced by the placement of the transosseous tunnels, which are tunnels in the~     bones through which the grafts pass. Presently the placement of the tunnels is being judged~     from arthroscopically identified anatomical landmarks within the joint. The result is~     incidence rates of misplaced tunnels as high as 40%. Computer assisted tunnel placement would~     aid in the correction and reproducibility of anatomic tunnel placement. The objective of this~     study is to conduct a prospective, randomized trial comparing clinical and radiographic~     outcomes in subjects who receive either a patella or hamstring tendon graft to reconstruct a~     chronic tear of the anterior cruciate ligament. All subjects will be further randomized into~     a computer-assisted or a conventional arthroscopic surgical group to allow investigators to~     compare the precision and accuracy of tunnel placement between these surgical approaches. The~     main question under investigation is: does the increased accuracy of computer-assisted~     surgery make a clinical difference to the laxity of the reconstructed knee, and is the laxity~     further influenced by the type of tendon graft received?~   "
248486|NCT00300287|"~     This study is not being conducted in the United States. Key long-term clinical studies have~     shown that people with type 2 diabetes should try to achieve overall blood glucose levels as~     close to normal as possible. The purpose of this study is to gather data on the long-term~     safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering~     overall blood glucose levels in people with type 2 diabetes who have not been previously~     treated with drug therapy to lower their blood sugar and whose blood glucose levels are close~     to normal.~   "
248487|NCT00300274|"~     This trial was to examine the impact of everolimus and reduced dose of cyclosporine on~     efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in~     heart transplant recipients.~   "
248488|NCT00300261|"~     We are testing the use of telehealth technology that includes self monitoring of blood~     pressure, weight, blood sugar, and oxygen levels for patients with heart failure who are~     receiving home care. We are interested to learn if using the equipment results in improved~     self care and decreased incidence of rehospitalization.~   "
248489|NCT00300248|"~     Acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is a severe lung condition~     that causes respiratory failure. Individuals with ALI/ARDS often require the use of a~     respirator or artificial breathing machine, known as a mechanical ventilator, while in an~     intensive care unit (ICU). Past research has shown that improved short-term clinical outcomes~     result from the use of a protective mechanical ventilation technique for the lungs. This~     study will evaluate the effects of lower tidal volume ventilation, and other aspects of~     critical illness and ICU care, on the long-term clinical outcomes of individuals with~     ALI/ARDS.~   "
248490|NCT00300235|"~     Priapism, a prolonged erection of the penis, is a medical issue that often affects men with~     sickle cell disease. The purpose of this study is to collect demographic and clinical~     information on priapism by interviewing men with sickle cell disease.~   "
248491|NCT00300222|"~     The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 60~     minutes for the treatment of postherpetic neuralgia (PHN).~   "
248492|NCT00300209|"~     Description: The Manhattan HIV/Hepatology Brain Bank (MHBB) was established in 1998 as a~     resource for the AIDS research community. The MHBB was created to act as a center for the~     provision of pre- and post-mortem tissues and body fluids from HIV infected persons. It has~     recently expanded its goals to assist in the elucidation of liver disease-induced nervous~     system disorders.~      The MHBB is dedicated to improving the understanding of HIV and Hepatitis C and thereby,~     improving the lives of patients living with HIV and/or Hepatitis C.~      Participation is voluntary and can be stopped at any time.~      Benefits: This is an observational study; no experimental procedures, devices or drugs are~     used. All enrolled patients undergo regular examinations by physicians, nurses, and~     neuropsychologists who specialize in the problems that HIV and HCV can cause.~      Taking part in this study may result in the detection of brain, muscle, or spinal cord~     disease for which treatments may be available. Participants may receive no direct benefit~     from this study. However, knowledge gained from this research may, in the future, help others~     who suffer from HIV/AIDS and/or liver disease.~      Participants agree to autopsy and organ donation upon demise by signing an Anatomical Gift~     Consent document.~   "
248493|NCT00300196|"~     The primary purpose of this study is to determine whether a brief intravenous infusion of~     ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.~   "
248494|NCT00300183|"~     This study evaluates outreach to HIV-infected people living in unstable housing in New York~     City who are new to CitiWide Harm Reduction. One hundred and fifty people are interviewed~     every 6 months, and their medical records are reviewed every 6 months for a total of 18~     months. The study examines how outreach, case management, housing, drug use, mental health,~     and quality of life are related to people's ability to get into and stay in medical care.~   "
248495|NCT00300170|"~     This study is to look at things that may affect whether or not people who are HIV-infected~     get into medical care and stay in medical care. some of the things that will be examined~     include how drug use, HIV disease severity, mental health, housing, trust, feelings of~     discrimination, social support, relationship with provider, and patient's race and provider's~     race are linked with whether or not people get health care. People who are enrolled in the~     study will be interviewed once, and their medical records will be examined.~   "
248496|NCT00300157|"~     The purpose of this study is to determine whether percutaneous coronary angioplasty with~     Taxus drug eluting stent is safe and effective in the treatment of unprotected left main~     coronary artery disease associated to other coronary lesions or not.~   "
248497|NCT00300131|"~     Prospective, open-labeled First in Man Clinical Investigation enrolling patients with~     visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x~     18 mm BVS EECSS containing 98 microgramme per cm² of surface area.~   "
248498|NCT00300118|"~     The purpose of this study is to determine whether mesalazine or budesonide is more active in~     the treatment of active Crohn's disease.~   "
248614|NCT00298584|"~     The purpose of this study is to determine which of the two procedures commonly used to~     collect urine, percutaneous suprapubic aspiration (SPA) and urethral catheterization (UC), is~     less painful, and the success rates and complication rates associated with both methods.~   "
248499|NCT00300105|"~     This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to~     monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in~     patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including~     treatment and follow-up, is 103 weeks.~   "
248500|NCT00300092|"~     Study objective: Fingertip injuries are common in the pediatric population. Considerable~     controversy exists about whether prophylactic antibiotics are necessary after repair of such~     injuries. Our goals were to estimate the rate of bacterial infection among pediatric patients~     with distal fingertip injuries overall and to compare the rate of bacterial infections among~     subgroups treated with and without prophylactic antibiotics.~      Methods: This was prospective randomized control study of pediatric patients presenting to an~     urban children's hospital with trauma to the distal fingertip requiring repair. Patients were~     randomized to two groups: those receiving prophylactic antibiotics (Cephalexin) and those who~     did not receive antibiotic therapy. Repairs were performed in a standardized fashion and all~     patients were re-evaluated in the same emergency department in 48 hours and by phone 7 days~     later. The primary outcome of this study was the incidence of infection.~   "
248501|NCT00300079|"~     This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0%~     compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy~     over a 24 hour period in patients with glaucoma or ocular hypertension.~   "
248502|NCT00300066|"~     The purpose of this study is to assess serum cystatin C as a marker of kidney function~     (glomerular filtration rate, GFR) in children aged 2-14. The individual production rate and~     possible extra renal elimination of cystatin C based on body composition data is included to~     develop new algorithms to estimate GFR.~      Furthermore, day-to-day variation on serum cystatin C is investigated.~   "
248503|NCT00300053|"~     The purpose of this study is to evaluate the efficacy and safety of intramyocardial~     injections of adult stem cells in patients with refractory chronic myocardial ischemia.~   "
248504|NCT00300040|"~     The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing~     adequate wound healing in patients with severe peripheral vascular disease who are undergoing~     lower limb amputation.~      The hypothesis is that HBOC-201 will pass through the partially occluded lesions in the~     peripheral arteries in the lower extremity and promote the wound healing process by~     delivering oxygen to the oxygen deprived tissues. This will reduce the incidence of lower~     limb wound complications at 60 days post-surgery and may reduce the incidence of a second~     amputation.~   "
248505|NCT00300027|"~     The purpose of this study is to define the recommended dose of BMS-582664 that could be~     safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil,~     leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced~     gastrointestinal malignancies and to evaluate the safety profile, tolerability,~     pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.~   "
248506|NCT00300014|"~     The Purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing~     recurrent post-vitrectomy diabetic hemorrhage with conventional treatment, air-fluid~     exchange.~   "
248507|NCT00300001|"~     The primary research objective of this protocol is to evaluate the impact of integrating a~     home-based symptom monitoring system in the day-to-day care of cancer patients in community~     settings on the frequency of supportive symptom interventions, symptom severity, and quality~     of life.~   "
248508|NCT00299988|"~     The overall goal of this double-blind Phase II study is to evaluate the safety, efficacy and~     biological mechanisms of action of Intravenous Immunoglobulin (IVIg) in the treatment of mild~     to moderate stage Alzheimer's disease (AD). IVIg contains antibodies against the amyloid beta~     protein that is the central component of the AD senile plaque. It is hypothesized that IVIg~     treatment will reduce the levels of beta amyloid in the brain and improve cognitive abilities~     relative to placebo. A total of 24 patients with mild to moderate AD capable of giving~     informed consent will be randomly assigned to receive either IVIg (16 patients)or saline~     placebo (8 patients) for six months. This study includes comparison of four dosing regimens~     of IVIg. Cognitive, behavioral and functional measures will be collected at baseline, three~     months and six months of treatment. Plasma samples will be collected before and after~     infusions. Subjects will undergo a lumbar puncture before and after the six months of~     treatment for cerebrospinal fluid (CSF) biomarker analyses. In addition, Positron Emission~     Tomography (PET) imaging substudies will be performed at two time points during the study.~     Following the initial 6 month placebo-controlled period, all participants have the~     opportunity to receive IVIg for an additional 12 month period in an extension study.~   "
248509|NCT00299975|"~     Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but~     treatment for this condition in conventional medicine is suboptimal. Complementary and~     alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by~     patients with FC, but there is little research evidence about these commonly used CHM. The~     purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the~     optimal dosage.~   "
248510|NCT00299962|"~     This Phase I study will evaluate the safety of two doses of BG00001 at different doses and~     intervals. Eligible subjects will have:~        -  malignant pleural mesothelioma, or~        -  pleural effusions who have progressed through at least one prior therapy or have refused~          therapy~      BG00001 is given twice through a catheter in the pleural space.~   "
248511|NCT00299949|"~     Sepsis is the 13th most common cause of death in the United States, causing approximately~     210,000 deaths per year. Once DIC has developed, irreversible organ injury has already~     occurred and the mortality rate is 70%. Inhibition of systemic coagulation with activated~     protein C concentrate has been the only therapy for sepsis introduced in the past several~     decades which has improved outcomes. Elucidation of the coagulopathic mechanisms early in the~     development of DIC may give rise to targeted therapies and strategies for early intervention.~     We hypothesize that an increase in endogenous thrombin potential precedes the development of~     overt DIC by a clinically significant time period. Our primary objective is to determine if~     endogenous thrombin potential (ETP) measured at first diagnosis of sepsis prior to the onset~     of DIC and organ failure is predictive of overt DIC and/or poor outcome. We will compare ETP~     to standard coagulation assays and the clinical assessment of DIC using the ISTH criteria for~     overt DIC. A secondary objective of this study is to determine if host coagulation variables~     predispose to the development of DIC and poor clinical outcome during sepsis.~   "
248513|NCT00299923|"~     The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1~     or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a),~     Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same~     combination, given for 48 weeks (group B) in patients who relapsed to previous combination~     therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined~     as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24~     GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.~   "
248514|NCT00299910|"~     This study will assess in a double blind placebo controlled fashion the effects of a 12 week~     course of oral montelukast/placebo on polysomnographic and radiological findings and will~     characterize the systemic (serum,urine) and local (upper airway collected biological samples)~     inflammatory response in children (2-10 years of age) with sleep disordered breathing,~     fittingthe inclusion and exclusion criteria.~   "
248515|NCT00299897|"~     This is a 28-day, multi-center, placebo-controlled study designed to look at the dose~     response, efficacy, and safety of SP01A, given as a pill to be swallowed, in the treatment of~     HIV-infected subjects.~      Samaritan has discovered that SP01A affects cholesterol binding, which is directly implicated~     in the pathogenesis of HIV. It has also been established that drugs of this nature exert an~     anti-HIV effect in-vitro. These data suggest that SP01A has the potential to reduce HIV virus~     replication.~      One measurement of an HIV infected person’s risk of progressing to AIDS is the number of~     viral particles of HIV in their blood (called a “viral load”). This study is designed to see~     if SP01A will lower the amount of HIV in an infected individual's blood. Patients will be~     assigned by chance to 1 of 4 groups. Neither the patient nor the study doctor or nurse will~     know which dose of the study drug the patient is taking or if he/she is receiving the placebo~     (a capsule that looks like the study drug but does not contain any active ingredient).~      Study drug administration will continue for 28 days. At the end of the 28-day study, the~     patient will be offered testing of his/her virus for resistance to approved drugs (genotype).~   "
248516|NCT00299884|"~     The primary aim of this study is to evaluate the efficacy and non-inferiority of a~     lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate~     taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C)~     cholesterol. Additionally, other aims would include effects on other types of blood~     cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to~     atorvastatin.~   "
248517|NCT00299871|"~     To evaluate the dose-response relationship of AVE0010 administered once daily and twice daily~     with chronic dosing in metformin-treated subjects with type 2 diabetes~   "
248518|NCT00299858|"~     This will be a prospective randomized double-blinded parallel group clinical trial evaluating~     the short-term effects of theophylline therapy on exercise duration and lung function in~     patients with chronic obstructive pulmonary disease already receiving both tiotropium and a~     long-acting beta-agonist (salmeterol or formoterol).~   "
248519|NCT00299845|"~     Proton pump inhibitors are administered to children as off-label use in Japan. The purpose of~     this study is to evaluate the effects of CYP2C19 genotypes on pharmacokinetic~     /pharmacodynamic profiles of PPI in children. The results will provide the beneficial~     information for the individualized medicine of PPI in children.~   "
248520|NCT00299832|"~     Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in~     hypertensive patients with renal dysfunction~   "
248521|NCT00299819|"~     The primary objective of this study is to evaluate the safety and tolerability of~     intravenously administered MEDI-545 compared with placebo, over a dose escalation range of~     0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of~     prednisone orally or an equivalent dose of another oral corticosteroid.~   "
248522|NCT00299806|"~     Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe~     hypertension~   "
248523|NCT00299793|"~     The purpose of this study is to assess efficacy, safety and tolerability of lamotrigine as~     used in a natural clinical setting, to examine the positive effects of lamotrigine, and the~     reasons why some patients choose to continue or discontinue lamotrigine.~   "
248524|NCT00299780|"~     The purpose of this study is to determine the safety of parathyroid hormone in combination~     with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize~     sufficient progenitor stem cells after one or two attempts.~   "
248525|NCT00299767|"~     The purpose of this study is to determine the safety of sequential cord blood transplantation~     (2 cord blood units) for patients who have diseases that are capable of being cured by~     allogeneic stem cell transplant but do not have a matched family or volunteer unrelated~     donor.~   "
248526|NCT00299754|"~     Most studies of labour induction with misoprostol used doses higher than 25mg and intervals~     of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as~     single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg~     dinoprostone pessary.~   "
248527|NCT00299741|"~     -  There are nearly 30,000 deaths per year in the United States from prostate cancer,~          making this a large and important target patient population for new cancer treatments.~        -  SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or~          more specifically receptor tyrosine kinases, in tumor cells. These proteins are active~          in cellular pathways that are important for development and growth of a variety of~          different cancers. The targets of SU011248 include the receptors for vascular~          endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By~          blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that~          nourish the cancer cells and death of the cancer cells themselves.~        -  SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma,~          gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer~          has not been studied to date.~        -  This study is directed at two populations of men with advanced prostate cancer:~             1. Men with advanced prostate cancer who have a rising PSA despite hormone therapy,~               but have not yet received any chemotherapy.~             2. Men with metastatic prostate cancer who have received prior chemotherapy (with a~               docetaxel-based regimen) and have increasing disease following chemotherapy.~        -  Men in this study will receive SU011248 on a six-week repeating schedule, with four~          weeks of daily treatment followed by a two-week rest. The goals of the study are:~             1. to determine whether SU011248 is an important therapeutic agent in men with~               advanced prostate cancer, and~             2. to identify predictive markers of anti-cancer activity within individual subjects~               that would allow selective treatment of appropriate subjects in the future.~   "
248555|NCT00299377|"~     Randomized comparison of abciximab i.v. versus i.c. in patients with STEMI undergoing primary~     PCI. The hypothesis is, that higher concentration of abciximab i.c. leads to improved~     epicardial flow, perfusion, reduction of no-reflow, reduction in infarct size and~     subsequently better outcome.~   "
248528|NCT00299728|"~     This is a phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG~     7909 and Montanide® ISA-51 and NY-ESO-l protein 400µg with immune adjuvants CpG 7909 and~     Montanide® ISA-51 in patients with tumors that often express NY-ESO-1.~      The vaccinations will be administered subcutaneously every 3 weeks for 4 doses.~      Patients with any malignancy that is known to frequently express NY-ESO-1 will be eligible,~     regardless of whether antigen expression in the autologous tumor can be demonstrated or not~     by either PCR or immunohistochemistry.~      The primary objective of the study is to define the safety.~      Secondarily, the study will evaluate whether patients develop a specific immunologic response~     to the NY-ESO-1 protein. Blood samples will be obtained at baseline, prior to each~     vaccination, one week after each vaccination, and at the last study visit for the assessment~     of NY-ESO-1 specific CD4+ and CD8+ T-cells. Cytokine secretion by NY-ESO-1 specific CD8+ and~     CD4+ T-cells, as a measure of T-cell activation, will be determined by FACS analysis. In~     addition, humoral immunity will be determined by the presence of NY-ESO-1 specific antibodies~     which will be assessed in all patients by ELISA.~      Disease status will be assessed at baseline and 2-4 weeks after the fourth vaccination in~     patients with evaluable (measurable and non-measurable disease).~   "
248529|NCT00299715|"~     The purpose of this study is to evaluate the effectiveness and safety of 3 different doses of~     paliperidone extended release (ER) compared to placebo in patients diagnosed with Bipolar I~     Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate~     the effects of paliperidone extended release on global functioning, and the relationship~     between blood levels and the effectiveness and safety of paliperidone.~   "
248530|NCT00299702|"~     The purpose of this study is to compare the effectiveness of two antipsychotic medications,~     RisperdalÂ® ConstaÂ® versus AbilifyÂ®, over a 2-year treatment period in the long-term~     maintenance of patients with schizophrenia.~   "
248531|NCT00299689|"~     The purpose of this study is to determine whether ONTAK is an effective treatment in patients~     with Stage IV Melanoma~   "
248532|NCT00299676|"~     The purpose of this observational study is to investigate the changes in cognitive~     functioning, behavior, and functional improvement in Alzheimer's disease patients treated~     with Galantamine who are living at home (i.e. not in permanent residential care), and to~     obtain information regarding usual clinical practice that can be used for communicating~     treatment expectations to patients and supporters.~   "
248533|NCT00299663|"~     Group A streptococcus (GAS) causes a variety of human infections. It is also an uncommon but~     serious cause of postpartum infections. In contrast to group B streptococcus (GBS) infection,~     which causes illness and death in newborns disproportionately more often than it does in~     mothers, perinatal GAS infection primarily affects mothers . Invasive GAS infection is~     defined by the isolation of GAS from a normally sterile site (e.g., blood) or by the~     isolation of GAS from a nonsterile site in the presence of the streptococcal toxic shock~     syndrome or necrotizing fasciitis. A postpartum case of invasive GAS is defined as isolation~     of GAS during the postpartum period, in association with a clinical postpartum infection~     (e.g., endometritis) or from either a sterile site or a wound infection.~      Because of the burden and severity of invasive GAS infection, the Centers for Disease Control~     and Prevention (CDC) hosted a meeting in to formulate guidelines for responding to postpartum~     and postsurgical GAS infections. However, we could not find any recommendations for long-term~     follow-up of patients who had GAS infection subsequent to delivery or gynaecological~     procedures, or further recommendations regarding subsequent delivery or gynaecological~     invasive procedures. It is possible that women who had GAS as a cause of vaginal infection~     may have a tendency to be carriers of this organism, but this has never been proven. We~     believe it is of importance to determine if women who have had one infection may be long-term~     carriers which may pose a risk during future pregnancies.~      The objective of the present study is to evaluate the incidence of long term gynaecological~     carrier state of patients who had GAS invasive infection following delivery, and to provide~     guidelines for follow-up and treatment of such patients.~      The proposed study may answer the question whether this endogenous GAS origin represents~     chronic GAS carrier state, similar to the known GBS carrier state. As some of these patients~     had severe infections (sometimes life threatening) a protocol for long-term follow up and~     management is necessary in case an invasive procedure is done (IUD insertion, endometrial~     biopsy, curettage or delivery) in order to prevent recurrent infection. The information~     collected in the study will enable us to afford recommendations for follow up and prophylaxis~     in the future.~   "
248534|NCT00299650|"~     The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively~     investigated. The aim of the study is to show a reduction of the mortality rate of ARDS~     patients.~   "
248535|NCT00299637|"~     This study will try to determine whether fetuses to mothers having clinical chorioamnionitis~     have changes in blood flow in middle cerebral artery.~   "
248536|NCT00299624|"~     Aging is an independent risk factor, without any clear explanation. The primary aim of the~     study is to depict the effect of aging on the coagulation fibrinolysis parameters and~     microparticles.~   "
248537|NCT00299611|"~     The purpose of this study is to evaluate the effectiveness of Levetiracetam augmentation~     relative to Placebo in SSRI non-remitters with obsessive compulsive disorder. The hypothesis~     is that anxiolytic effect of Levetiracetam is more beneficial when adding with a SSRI.~   "
248538|NCT00299598|"~     Resin composites withholding antibacterial properties may be useful in preventing recurrent~     caries. Covalently attached antibacterial polymers are a possible solution.This in vivo study~     would evaluated the antibacterial effect of alkylated polyethylenimine nanoparticles~     incorporated into flowable and hybrid composite resin disks embedded in a palatal removable~     appliance.The disks would be in close contact with the palate in order to check for contact~     mucosities. disks on the side facing the Tongue would be evaluated for their antibacterial~     potency with confocal laser scanning microscopy.~   "
248539|NCT00299585|"~     Objective: The evaluation of PD VitalOs Cement, an injectable brushite, as a stabilizer of~     dental implants and a potential source for bone augmentation.~      Methods: Forty (40) patients needing dental implants will be treated where needed with PD~     VitalOs Cement gapping half of their sites whereas the other half will be gapped with Bio-oss~     demineralized bone and BioGuide membrane.~   "
248556|NCT00299364|"~     The benefit-risk-balance of the isopropanolic Cimicifuga racemosa extract (iCR) is compared~     with tibolone in menopausal symptoms treatment. Menopausal patients aged 40 - 60 years and~     with a Kupperman Menopause Index (KMI) equal or more than 15 participate and were assigned to~     either iCR corresponding to 40 mg crude drug/day (n=122) or tibolone 2,5 mg/day (n=122)~     orally. The primary endpoint is the benefit-risk balance at end of treatment.~   "
248557|NCT00299351|"~     To evaluate the safety and tolerability of extended treatment with depsipeptide in patients~     who have at least demonstrated stable disease on prior Gloucester-sponsored depsipeptide~     clinical trials, and in the opinion of their physician/ investigator might benefit from~     continued treatment with depsipeptide~   "
248615|NCT00298571|"~     The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean~     deliveries will decrease post-op pain.~   "
248540|NCT00299572|"~     Hyperphosphatemia is frequently seen in patients with end-stage renal disease (ESRD).~     Hyperphosphatemia usually results in a high calcium-phosphorus product (CPP) which may~     subsequently lead to artery and become a risk factor of cardiovascular complications.~     Alendronate, due to its effect of inhibiting osteoclasts, is approved for treatment of~     osteoporosis. Previous reports found the use of bisphosphonates could suppress arterial~     calcification in hemodialysis dialysis patients. The aim of this study is to evaluate the~     safety and efficacy of alendronate to suppress coronary artery and aortic calcifications, as~     well as to improve bone density in chronic peritoneal dialysis (PD) patients.~      This study will include ESRD patients who had received maintenance PD for more than 3 months,~     have high CPP level (≧55), and have chest X-ray proven aortic calcification or coronary~     artery calcification. All participants are randomly allocated to either group 1 or group 2.~     Group 1 patients receive alendronate 70 mg once weekly in the first 16 weeks, while group 2~     patients receive the same dose of drug every week in the second 16 weeks. The extent of~     coronary artery and aortic calcification is evaluated by using multi-detector spiral computed~     tomography, whereas bone mineral density is measured by dual-energy X-ray absorptiometry.~     Both examinations are performed at week 0, 16 and 32 for each participant. Laboratory studies~     and possible adverse reactions were regularly monitored.~      We expect that alendronate can alleviate the progression of arterial calcification or even~     improve it. Bone density may also be improved after treatment. Besides, we wish to find the~     independent factor(s) influencing the efficacy of alendronate. These results may help~     clinical physicians for early intervention and prevention of cardiovascular complications in~     ESRD patients.~   "
248541|NCT00299559|"~     The purpose of the study is to determine whether the application form of etheric oils~     (camphor, cineol and menthol) causes changes in the concentration of this agents in the~     exhaled air. The second aim of the study is to determine differences in the subjective~     convenience of the application forms. We will test an commercial ointment application vs.~     smart textiles. Smart textiles are new high-tech products with the unique possibility to~     combine the textiles with functional products e.g. pharmaceutical agents.~   "
248542|NCT00299546|"~     The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in~     subjects who have active rheumatoid arthritis and have been treated previously with at least~     1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).~   "
248543|NCT00299533|"~     We are studying whether the addition of fish oil capsules, containing 2.2 gm of~     polyunsaturated fatty acids, when added to antiepileptic drugs improve seizure control.~   "
248544|NCT00299520|"~     This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive~     either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the~     first four days of study treatment and then every other day, for up to 14 days of the~     treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment),~     and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).~   "
248545|NCT00299507|"~     The purpose of this study was to evaluate the effect of the dose concentration and~     administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size~     when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months~     (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).~   "
248546|NCT00299494|"~     The purpose of the study is to determine the tolerability, the initial safety profile and~     maximum tolerated dose, and to obtain preliminary information on the antitumor activity of~     inotuzumab ozogamicin [CMC-544] in combination with rituximab in subjects with follicular,~     diffuse large B-Cell, or mantle cell NHL.~   "
248547|NCT00299481|"~     The purpose of this study is to create a tissue bank of gynecologic cancers and normal tissue~     for the study of cancer in order to better understand the changes occurring on a molecular~     level (DNA, RNA, protein) that lead to the development of cancer.~   "
248548|NCT00299468|"~     We will test - in a chronically ill managed long term care population - the effectiveness of~     an intervention that provides nurse Care Managers with an inventory of evidence-based~     practices tailored to patients with different levels of knowledge, skills and confidence to~     engage in self-care management. Specifically, we will develop a change package of~     evidence-based hypertension (HTN) management strategies geared to patients scoring at the~     four different stages of activation on the Patient Activation Measure (PAM). We will randomly~     assign a group of interdisciplinary teams in the managed long-term care plan to intervention~     or control status and will train the Care Managers on the Intervention teams to use the~     change package in conjunction with a patient's PAM score to design - with the involvement of~     the patient - an individualized HTN management plan. We then will assess the impact of the~     intervention on patient activation and outcomes.~   "
248549|NCT00299455|"~     This is a prospective, randomized, double-blind, placebo controlled one-center study carried~     out in primary care setting of the health center of City of Turku, Finland. The study~     patients will be allocated to one of the two parallel treatment groups~     (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute~     otitis media are resolved more effectively with antimicrobial treatment than with placebo.~     Furthermore, this study aims at finding out prognostic factors that could help to direct~     antimicrobial treatment for correct subgroups of young patients.~   "
248550|NCT00299442|"~     This project will introduce a self-help parent training programme for families on National~     Health Service (NHS) waiting lists for child mental health services. It will examine whether~     access to treatment can be increased by providing an intervention that requires fewer~     resources and by releasing clinician time for more serious cases. This intervention will be~     tested in a randomised, controlled trial in which 35 subjects will receive treatment~     immediately and 35 will receive treatment after waiting for 10 weeks. All families will also~     complete questionnaires before and after the 10 week study period in order to measure changes~     in child behaviour, parenting, and parental mental health. Cost-effectiveness of this~     programme will also be analysed. Intention-to-treat analyses will be conducted.~   "
248551|NCT00299429|"~     Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally~     invasive bypass surgery in patients with isolated proximal left anterior descending coronary~     arteries in terms of non-inferiority of an end point combining mortality, acute myocardial~     infarction and rate of reintervention of the target vessel within one year.~   "
248552|NCT00299416|"~     Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2~     glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two~     hour while being cooled to 34.5 C.~   "
248553|NCT00299403|"~     The aim of the present study is to compare the antidepressant effect of electroconvulsive~     therapy ( ECT) with that of low frequency repetitive transcranial magnetic stimulation of the~     right prefrontal cortex.~      In the same study we investigate the value of saliva cortisol as a predictor of treatment~     outcome.~   "
248558|NCT00299338|"~     This a Phase I/II non-randomized, open-label clinical study of 8 weeks duration using SP01A~     in HIV positive patients on a stable antiretroviral regimen. Dose response and safety~     associated with oral administration of four doses (200 mg, 400 mg, 600 mg, and 800 mg daily)~     of SP01A will be studied in a total of 24 study subjects. In addition, six HIV-negative~     subjects will be recruited as a control for cortisol secretion only and will not receive~     study medication.~   "
248559|NCT00299325|"~     Primary objective:~      To assess the effect of rimonabant on visceral fat area over a period of 12 months when~     prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome~      Secondary objectives:~        -  To assess the effect of rimonabant over a period of 12 months on:~             -  Liver fat content using CT scan (Computed Tomography scan)~             -  Anthropometric measures (weight, waist circumference, body composition using Dual~               Energy X-ray Absorptiometry (DEXA))~             -  Lipid, lipoprotein profile~             -  Glycemia, insulinemia and HbA1c~             -  Adipokines, inflammatory and hemostatic markers~        -  To evaluate the percentage of patients with metabolic syndrome at 12 months~        -  To evaluate the safety and tolerability of rimonabant in these patients~      In four selected US sites the effect of rimonabant at 12 months will be also assessed on:~        -  Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp).~        -  Resting metabolic rate and substrate oxidation at rest using indirect calorimetry.~        -  Adipose tissue histology and expression of genes involved in glucose and lipid~          metabolism (superficial adipose tissue biopsy).~   "
248560|NCT00299312|"~     Rett Syndrome (RTT) is a genetic brain disorder that occurs almost exclusively in females and~     is usually caused by a change (mutation) in the gene MECP2. The disorder is characterized by~     multiple developmental problems, as well as behavioral features, such as repetitive~     stereotypic hand movements, including hand washing, wringing, and tapping. While there is no~     cure for RTT, recent advances in the understanding of the disease suggest that the~     development of new, effective therapies is promising. This study will gather information on~     the genetic defects that cause RTT, the physical expressions of these defects, and disease~     progression. In turn, this may direct the development of future treatments. Expanded studies~     include individuals with MECP2 Duplication disorder, and RTT-related disorders including~     individuals with MECP2 mutations, but not meeting obligatory criteria for the diagnosis of~     RTT and individuals with mutations in CDKL5 and FOXG1 some of whom meet criteria for atypical~     RTT.~   "
248561|NCT00299299|"~     This study tests the feasibility and reproducibility of patient-specific motion models. These~     will be used for quantification of safe margin reduction. Patient-specific motion models will~     be built by post-processing 4D MRI data with non-rigid registration. By comparing these~     models between visits, model reproducibility will be assessed, and the methodology refined.~   "
248562|NCT00299286|"~     To provide an in vivo measure of the activity of lapatinib. To assess the antiproliferative~     effects of lapatinib in breast cancer, ie how much lapatinib slows down the growth of cancer~     cells by measuring K167 (a marker of proliferation) in breast tumours before and after a~     short treatment with lapatinib.~   "
248563|NCT00299273|"~     The purpose of this study is to examine the effects of a low calorie high fat/protein diet on~     body fat and body composition in overweight and obese subjects. The investigators will also~     test the effects of this diet on secondary outcomes such as: fluid and electrolyte balance,~     cholesterol, inflammation, sugar and insulin metabolism, fat hormones, blood pressure and~     feelings of fullness.~   "
248564|NCT00299260|"~     Patients who receive transplants are at increased risk of developing serious cytomegalovirus~     (CMV) infections because they have a decreased immune system. The purpose of this study is to~     evaluate the safety and immune response of a CMV vaccine in patients (18 years old and older)~     who are awaiting a transplant. Following immunization with vaccine or placebo (inactive~     substance), patients will be followed for the development of immune responses to CMV and for~     evidence of CMV infection following transplantation. One hundred forty eligible patients will~     receive 3 injections of the CMV gB vaccine or 3 doses of placebo during 5 visits.~     Participants will participate in the study for approximately 7 months (if they do not undergo~     a transplant) or 10 months (if they undergo a transplant).~   "
248565|NCT00299247|"~     The purpose of this study is to study resistance to current malaria treatments and affordable~     alternatives for uncomplicated malaria. Resistance occurs in areas where these treatments are~     used frequently. This study may help prevent future resistance. About 150 residents in~     Buenaventura, Colombia will participate. They will have uncomplicated malaria and they will~     be followed for 28 days after treatment. Physical exams and blood draws are included in study~     visits.~   "
248566|NCT00299234|"~     This study is a double-blind, placebo-controlled, parallel group trial of atomoxetine (1.8~     mg/kg) for the management of chemotherapy-related acquired attentional disorders in children~     who have survived Acute Lymphocytic Leukemia. Atomoxetine will produce a favorable impact on~     ADHD symptoms in children with chemo-related acquired attentional disorders.~   "
248567|NCT00299221|"~     This was a study to compare less intense immunosuppression with a more traditional approach.~     The hypothesis was that less immunosuppression will provide similar protection against~     rejection than typical 2-3 drug therapy.~   "
248568|NCT00299208|"~     The goal of this study is to develop a safe, well tolerated, and highly efficacious~     azithromycin combination treatment for uncomplicated falciparum malaria. Azithromycin is a~     drug that has shown potential for malaria treatment. It will be combined with other malaria~     drugs currently approved for treatment in Thailand. About 120 people, ages 20-65, will be~     enrolled in Thailand. Participants will have severe cases of malaria and they will be~     hospitalized 28 days for treatment.~   "
248569|NCT00299195|"~     The purpose of this study is to see if a drug called sulindac can prevent the development of~     changes in the mouth that are related to oral pre-cancer growths (oral epithelial dysplasia)~     or oral cancer. Sulindac is an anti-inflammatory drug that has already been tested in people~     with arthritis (inflammation of a joint).~      This study is being done by Memorial Sloan-Kettering Cancer Center in New York, Amrita~     Institute of Medical Sciences and Research Center in Cochin, India, and Regional Cancer~     Centre (RCC) in Trivandrum, India.~   "
248600|NCT00298766|"~     This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with~     VELCADE in patients with previously treated systemic AL-amyloidosis who require further~     treatment.~   "
248570|NCT00299182|"~     The goal of this clinical research study is to find the highest safe dose of AMG 531 that can~     be given to treat thrombocytopenia (low platelet counts) in patients who have received~     chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531.~      Primary Objectives:~        1. To determine the clinical safety and tolerability of AMG 531 administered following~          chemotherapy (R-HyperCVAD alternating with R-Ara-C/MTX) in patients with non-Hodgkin's~          lymphoma.~        2. To determine an optimal biologic dose (OBD) of AMG 531 in patients receiving R-HyperCVAD~          and R-Ara-C/MTX.~        3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and~          platelet recovery following chemotherapy(chemo).~      Secondary Objectives:~      1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route with~     chemotherapy.~   "
248571|NCT00299169|"~     Patients who are intolerant of statins in routine practice, but who lack objective evidence~     of significant harm, will be randomized to receive statins by either n of 1 trials or~     standard practice. Our hypothesis is that n of 1 trials will improve statin adherence,~     thereby improving low density lipoprotein cholesterol (LDL-C) levels.~   "
248572|NCT00299156|"~     The goal of this clinical research study is to learn if clofarabine given by mouth on a~     weekly schedule can help to control MDS. The safety of clofarabine given by mouth will also~     be studied.~   "
248573|NCT00299143|"~     The purpose of this study is to determine whether shear-induced platelet aggregation is able~     to discriminate first acute coronary syndrome (ACS) from recurrent ACS~   "
248574|NCT00299130|"~     This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid~     arthritis (RA).~   "
248575|NCT00299117|"~     The primary purpose of this study is to examine the effect of a brief preoperative smoking~     intervention on postoperative complications in women undergoing breast cancer surgery.~      Secondary purposes are to examine long-term smoking cessation rates and experienced stress~     and nicotine withdrawal symptoms during the smoking cessation period.~   "
248576|NCT00299104|"~     This is a phase III, randomized, controlled, double-blind, parallel group, international~     study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to~     Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be~     enrolled and will be allocated equally between 3 treatment arms.~   "
248577|NCT00299091|"~     This is a study on the utility of the modification of doses of efavirenz guided by its plasma~     concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment~     with Sustiva.~   "
248578|NCT00299065|"~     The prevalence of asthma continues to increase. Despite the large number of available~     therapies, many patients continue to require emergency deparment (ED) visits and intensive~     therapy. However, ED visits continue to be a major contributor to the healthcare cost of~     asthma treatment. In the United States alone, asthma is the 11th most common reason for ED~     visits, with ED visits and hospitalizations accounting for almost 50% of the healthcare cost~     for asthma. Additionally, while only 20% of asthmatics have had ED visits or~     hospitalizations, these patients account for over 80% of the direct costs for asthma~     treatment. Current National Asthma Education and Prevention Program (NAEPP) guidelines~     regarding management of acute asthma exacerbations in the ED setting include: oxygenation for~     most patients, inhaled short-acting β2-agonists and systemic corticosteroids.~      Zileuton, a specific 5-lipoxygenase inhibitor, has been extensively studied in inflammatory~     diseases such as asthma, which involve leukotrienes as mediators of inflammation. Zileuton~     Immediate Release (IR) tablets (Zyflo®) were approved by the Food and Drug Administration~     (FDA) in December 1996 for the prevention and treatment of asthma in adults and children 12~     years of age and older. The results of the 2 pivotal studies in asthmatics with zileuton IR~     tablets demonstrated that zileuton at a dose of 600 mg QID produced and maintained a lasting~     improvement of lung function. In addition to the lasting effect of zileuton, an acute~     bronchodilation (as early as 60 minutes) was observed after administration of the first 600~     mg oral dose.~      This acute bronchodilator effect may benefit patients during an acute exacerbation of asthma~     when added to the usual care in the ED or clinic setting. Critical Therapeutics has developed~     an injectable formulation of zileuton that will be explored for use in acute asthma~     exacerbations. This initial study is intended to provide PK data, information on safety and~     tolerability and some indication of pharmacologic activity as evidenced by lung function~     changes. In an attempt to enhance the potential for observing effects on lung function, only~     those patients with a demonstrated ability to respond by an increase in FEV1 of at least 10%~     within 3 hours after oral zileuton dosing will be enrolled.~   "
248579|NCT00299052|"~     The Tibia bone (shinbone) is located in the leg, itis the most frequently fractured bone in~     the body and has very poor blood supply because it is surrounded by skin and fat instead of~     muscle like the thighbone causing healing problems. Problems frequently found during the~     healing process are malunion (bone heals in the wrong place), nonunion (the bone never~     heals), and compartment syndrome (a big inflammation of muscle that causes compression of~     nerves and blood vessels) with necrosis (death) of tissue. Surgeons have tried to decrease~     these problems by using different surgical techniques and substances to accelerate healing.~     Substances frequently used in fractures are bone grafts. Bone grafts are normally obtained~     from the wrist or the hip bone, and sometimes can cause other complications varying from pain~     to infection. To avoid complications, investigators have used alternatives such as obtaining~     bone from donors. The donor bone grafts are carefully analyzed and cleaned to ensure they~     will not cause problems for the receiver. Bone obtained from donors is called Demineralized~     Bone Matrix (DBM). DBM has proved to be very effective in helping fractures to heal faster~     and we want to use it in patients with tibia fractures.~      This study is important because DBM can improve the way tibia fractures are treated and could~     have the potential to decrease the time patients must stay in the hospital. DBM could improve~     healing time and diminish overall costs. Also, with the use of DBM plus reamings, patients~     will have fewer complications like pain and infection.~   "
248580|NCT00299039|"~     Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol~     #3® (300 mg acetaminophen, 30 mg codeine, 15 mg caffeine per tablet). We are proposing to~     test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients~     undergoing outpatient breast surgery.~   "
248581|NCT00299026|"~     The clinical investigation is an international, prospective, double-blind, randomized safety~     and efficacy study. The purpose of this study is to evaluate the safety and performance of~     the NIRx(TM) Paclitaxel-Coated Stent (1.0µg/mm2 of paclitaxel incorporated into slow- and~     moderate-release formulation of a triblock copolymer carrier system)in patients who present~     for stenting of de novo lesions of a native coronary artery.~   "
248582|NCT00299013|"~     The purpose of this study is to investigate whether a novel dosage form of a prednisolone~     ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.~   "
248583|NCT00299000|"~     The purpose of the study is to evaluate the safety and efficacy of two dose levels of~     Naglazyme in infants under the age of one year who have MPS VI by monitoring physical~     appearance, x-ray of the skeletal system and growth.~   "
248584|NCT00298987|"~     The purpose of this clinical research study is to provide dasatinib treatment to patients~     with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute~     lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The~     safety of the treatment will also be studied.~   "
248585|NCT00298974|"~     The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR~     to placebo in subjects with osteoarthritis (OA) of the hip or knee.~   "
248586|NCT00298961|"~     In our study we will aim to examine the issues of cost analysis, quality of life, clinical~     efficacy and satisfaction of psychiatric consultations through videoconference in a primary~     care setting in comparison with in-person psychiatric treatment and primary care only. The~     main hypotheses of the study are: Satisfaction of the patients will increase, the use of~     telepsychiatry will reduce the costs for the primary and mental health care centers as well~     as for the patients, the treatment will be as effective as in-person treatment, the number of~     patients referred to mental health treatment will be higher than that of the previous year,~     quality of life will improve and that there will be a stigma reduction of mental illness.~   "
248587|NCT00298935|"~     The purpose of this study is to determine whether osteopathic manipulative treatment (OMT):~        -  decreases pain and improves physical functioning in women during the third trimester of~          pregnancy~        -  decreases complications during obstetrical delivery~        -  improves quality of life in the post-partum period~   "
248588|NCT00298922|"~     Pulmonary infection with Burkholderia cepacia complex (BCC) in patients with CF is often~     associated with a more rapid decline in lung function. Because of the resistance of BCC to~     many antibiotics, treatment options are often limited. New therapies to improve outcomes for~     patients infected with BCC are needed.~      However, because of the unpredictable nature of this pulmonary infection in CF, patients with~     BCC infection have been excluded from many CF therapeutic trials.~      Recent published trials in the United States, Australia, and the United Kingdom have all~     demonstrated clinical benefits from prolonged administration of azithromycin in CF. In these~     trials, the vast majority of patients were chronically infected with Pseudomonas aeruginosa.~      Patients with BCC were excluded from the US and UK trials, and only four patients with BCC~     infection were enrolled in the Australian trial. Thus, the effectiveness of azithromycin in~     CF patients infected with BCC is largely unknown and deserves further study.~      The two main ways by which azithromycin is thought to help with the chronic lung infections~     seen in CF are by [a] reducing inflammation and [b] direct effects on the bacteria, in~     particular P. aeruginosa. BCC pulmonary infection in CF is often associated with a large~     inflammatory response similar to or more severe than P. aeruginosa infection. If azithromycin~     works mainly by an anti-inflammatory mechanism, it should also be helpful in CF patients~     infected with BCC.~      Alternatively, azithromycin could have a direct effect on BCC as seen with P. aeruginosa as~     the two bacteria have many similarities.~   "
248589|NCT00298909|"~     The investigators want to study the relative effects of physical exercise vs.~     extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and low~     HDL cholesterol (good cholesterol) on~        -  lipid profile~        -  endothelial function as measured by ultrasound~      The endothelium is the inner part of the blood vessels. Impaired endothelial function is~     known to be associated with atherosclerosis which can ultimately lead to diseases such as~     stroke, heart attack and others. Endothelial function can be assessed non-invasively by~     ultrasound.~      Both interventions mentioned above have been shown to have a beneficial effect on lipid~     profile and endothelial function. However, the relative effects are unclear.~   "
248590|NCT00298896|"~     The purpose of this study is to evaluate the objective tumor response rate to SNS-595 in~     patients with small cell lung cancer (SCLC).~   "
248591|NCT00298883|"~     Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal~     transplantation.~   "
248592|NCT00298870|"~     The purpose of this study is to elucidate whether the individualized medicine based on NAT2~     gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug~     therapy for the pulmonary tuberculosis with isoniazid.~   "
248593|NCT00298857|"~     The purpose of this study is to compare the blood levels of valproic acid in subjects with~     different body weights and to evaluate whether the pharmacokinetic parameters of this drug is~     altered in the obese population.~   "
248594|NCT00298844|"~     The study aim is to establish a consecutive population of newly referred type 2 diabetes~     mellitus patients and among these to describe the degree of macrovascular disease by~     evaluating left ventricular systolic and diastolic function (echocardiography), myocardial~     perfusion (single-photon emission computed tomography (SPECT)), the peripheral vascular~     perfusion (strain gauge toe blood pressure measurements and a ultrasound scan of the a.~     carotis communis). Further, the degree of microvascular disease will be evaluated (glomerular~     filtration rate assessment, fundus photography and biotesiometry). Finally the cohort will be~     followed the next two years to assess the prognostic value of the above-mentioned parameters~   "
248595|NCT00298831|"~     The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio~     of 0.9 after a dose of sugammadex when administered at least 15 minutes after the last~     administration of rocuronium in a wide range of surgical procedures and anesthetic regimens~     (routine use). Safety evaluation is part of the study.~   "
248596|NCT00298818|"~     The purpose of this study is to assess the efficacy and tolerability in real-world clinical~     practice, of adjunctive zonisamide treatment in adult patients with developmental~     disabilities and epilepsy.~   "
248597|NCT00298805|"~     The purpose of this study is to compare depressive characteristics in migraine patients to~     those observed in patients with epilepsy in a previous study, and determine whether those~     symptoms are unique to patients with epilepsy.~   "
248598|NCT00298792|"~     The purpose of this study is to determine if a treatment for alcohol dependence that is~     specifically tailored to patients' patterns of drinking and coping strategies can result in~     better outcomes than more standardized treatments.~   "
248599|NCT00298779|"~     This is an open-label, randomized, multiple-dose, multicenter Pharmacokinetics drug-drug~     interaction study in patients with advanced solid tumors, including non-Hodgkin's lymphoma,~     who are in need of anti-tumor therapy. In addition, the impact of omeprazole on the~     pharmacodynamics of VELCADE will also be evaluated.~   "
248601|NCT00298753|"~     Patients treated with the antiepileptic drug Oxcarbazepine often develop syndrome of~     inappropriate secretion of antidiuretic hormone(SIADH)We want to test the hypothesis, that~     these patients have a higher reabsorption of water during the Aquaporine2 water channels,a~     higher concentration of Vasopressine (AVP), and a lower clearance of water.This situation~     will tend to normalize, when the patients are treated with fluid restriction~   "
248602|NCT00298740|"~     This research is being done to find out whether subjects previously treated with the~     implantable insulin pump (IIP) therapy, and now taking insulin by injection, will benefit~     from re-implantation of IIP. The investigators will see if IIP causes more stable control of~     blood sugar, with fewer highs and lows. People with type 1 diabetes previously implanted with~     the MiniMed Implantable Pump (MIP) model 2000 at Johns Hopkins may join this study.~   "
248603|NCT00298727|"~     Purpose: This study will compare the effectiveness and mediators of two different knowledge~     transfer (KT) interventions in terms of their impact on changing knowledge and behavior~     (utilization and clinical reasoning) related to health outcome measures.~   "
248604|NCT00298714|"~     There is evidence on the beneficial effects of the administration of angiotensin II type 1~     (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models~     of liver fibrosis in rodents and limited information in chronic hepatitis C with mild~     fibrosis.~      The purpose of this study is to investigate the effect of long-term administration of oral~     Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic~     hepatitis C and fibrosis F2-F3 (METAVIR score).~   "
248605|NCT00298701|"~     This trial is performed to assess whether the Grazax-R treatment is safe to use in children~     aged 5-12 years.~   "
248606|NCT00298688|"~     The purpose of this study is to determine the disease control rate at trial closure and after~     the first stage of the study in patients with relapsed or refractory SCLC and measurable~     disease treated with gefitinib~   "
248607|NCT00298675|"~     The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD)~     and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects~     with histologically documented advanced solid tumors that are refractory to standard therapy~     or for which no standard therapy is available. Additionally, the safety and tolerability and~     clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic~     breast cancer in the phase 1b portion of the study.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.~     Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
248608|NCT00298662|"~     The purpose of the study is to evaluate the safety and tolerability of a combination of~     interferon beta 1-b (Betaseron®) and tacrolimus (Prograf®) in patients suffering from~     multiple sclerosis (MS) who have failed treatment with currently approved drugs for MS~      Prograf is an immunosuppressant that weakens the immune reactions responsible to protect the~     organism against infections. It is currently available on the market for patients who have~     received an organ transplant, to prevent rejection. Because of its effect on the immune~     system, theoretically, Prograf should exert a significant effect in MS. It has been tried in~     a small number of MS patients at a lower dose than the one used in organ transplant, however~     the results of the study did not allow to draw definite conclusions on its safety and~     efficacy in MS.~      Betaseron is approved in Canada for the reduction of the frequency of relapses in patients~     with relapsing-remitting MS and for the slowing of progression and reduction of the frequency~     of relapses in patients with secondary-progressive MS. The combination of Betaseron and~     Prograf may result in an additive effect or an increase in the actions of the drugs. However,~     the combination of the two drugs has never been studied.~      The aim of this study is to see how well the combination of Betaseron and Prograf is~     tolerated by patients with MS. The side effects of the treatment, if any, will be followed.~     In addition, the efficacy of the combination will be evaluated.~   "
248609|NCT00298649|"~     The goal of this project is to develop and test the effectiveness of a Lay Health Advisor~     program to teach migrant and seasonal farmworkers about pesticide safety in their homes. This~     is a community-based collaborative research project in which we first conduct in-depth~     interviews with farmworkers to learn about their knowledge and beliefs relative to pesticide~     exposure in the home, and, second, develop the content of the Lay Health Advisor program~     based on this formative information. We will evaluate this program by conducting pre- and~     post-test interviews with farmworkers, and comparing safety and knowledge to a control group~     who receive other important health education.~   "
248610|NCT00298636|"~     Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and~     represent a non-opiate target for pain management. Activated spinal A1 receptors inhibit~     sensory transmission by inhibiting the slow ventral root potential, which is the~     C-fiber-evoked excitatory response associated with nociception. Adenosine may inhibit~     intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory~     nerve terminals to inhibit the release of substance P and perhaps glutamate. Although~     adenosine A3 receptors are not found in the nervous system, adenosine is also known to have~     anti-inflammatory properties that may contribute to pain relief in the peripheral setting of~     inflammation.~   "
248611|NCT00298623|"~     The primary objective of this trial is to assess the efficacy of XP13512 taken once daily~     compared to placebo for the treatment of patients suffering from Restless Legs Syndrome~     (RLS).~   "
248612|NCT00298610|"~     The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by~     individuals with uncomplicated malaria infection and to determine how fast it eliminates~     malaria infection from the body.~   "
248613|NCT00298597|"~     In the study we want to prove whether the subcutaneous application of granulocyte-stimulating~     factor (G-CSF) and erythropoetin (EPO) influence associative learning and/or motor skills of~     patients, who suffer from chronic stroke or amyotrophic lateral sclerosis. The study~     hypothesis is that G-CSF and EPO improve associative learning and/or motor skills.~   "
248617|NCT00298545|"~     The researchers are involved in a research program to understand how vitamin D and calcium in~     the diet or as supplements may lower the risk of colorectal polyps and cancer. To that end,~     the researchers are conducting a study of vitamin D supplementation in which volunteer~     subjects are provided a Western style diet for 2 separate 4 week periods at the Rockefeller~     University Hospital. During one of these 4 week inpatient periods, subjects receive calcium~     supplements and during the other 4 week inpatient period they receive a placebo tablet. The~     researchers determine changes within the colon as a result of supplementing the vitamin D in~     the presence of high and low calcium. A more detailed description of the study is provided~     below.~   "
248618|NCT00298532|"~     The OPALS Pediatric Study will examine the incremental impact of introducing a prehospital~     full advanced life support in pediatric patients.~   "
248619|NCT00298519|"~     Women of different ethnic groups have different diets that may affect the fatty acid content~     of their breast milk. Ethnicity may also have an independent effect on breast milk~     composition. The differences in fatty acid content of breast milk may influence the immune~     tolerance of breastfed babies, and hence the development of allergy.~   "
248620|NCT00298506|"~     This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506)~     combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.~   "
248621|NCT00298493|"~     All critically ill, mechanically ventilated patients in the Intensive Care Unit receive~     medications to relieve pain and anxiety. However, accumulation of these medications can be~     associated with serious complications, most notably longer time on the breathing machine and~     in the ICU. Two strategies have been shown to dramatically improve patient outcomes:~     nurse-directed protocols for giving sedation, and daily interruption of sedation. However,~     these strategies have not been widely adopted, because of physicians' concerns, and because~     it is unclear which strategy is better. Given that patient outcome is improved with either of~     these strategies, the fundamental question that arises is whether patients managed with a~     combination of two strategies which both reduce drug accumulation (protocolized sedation and~     daily interruption) have an even better outcome than patients managed with only one of them~     (protocolized sedation). We propose a multicenter study in which 700 critically ill,~     mechanically ventilated patients will have their sedation managed with protocolized sedation~     alone, or both strategies. Both groups of patients will have the following recorded: ICU and~     hospital lengths of stay, mortality, total sedative drug use, ICU human resources used, side~     effects and recall of their ICU stay. The results of this large multi-center trial will help~     to inform best practice with regard to sedation management of critically ill patients in~     Canada and elsewhere. In addition, reducing ICU stay could be economically attractive, as the~     cost of an ICU day in Canada is approximately $3000.~   "
248622|NCT00298480|"~     Transvaginal ultrasound of the cervix has become a common tool to evaluate patients who are~     at risk for preterm delivery. A shortened cervical length has been associated with an~     increased risk of preterm delivery. Dynamic cervical change is visible shortening(>6mm) of~     the cervix seen during the ultrasound examination. Prior studies have shown that the presence~     of dynamic change in patients with a shortened cervical length(<3cm) is not independently~     predictive of preterm delivery. However, a subset of patients with normal initial cervical~     length(>3cm) and dynamic change did demonstrate an increased rate of preterm delivery.~     Because this was a small sub-group, the present study was designed to obtain a larger sample~     size for further evaluation. The second focus of this study involves patients with a dilated~     cervix and whether cervical length adds predictive value to gestational age at delivery.~      Patients presenting to with symptomatic preterm labor(vaginal pressure or uterine~     contractions), who consent to the study, will undergo the standard evaluation for preterm~     labor(described in detail below.) The only additional evaluation is a prolonged transvaginal~     ultrasound of approximately 10 minutes to evaluate for the presence of dynamic change during~     a contraction.~      Null hypothesis:~      Symptomatic preterm labor patients, with normal initial cervical length(>3cm), who exhibit~     dynamic cervical change deliver at a gestational age equal to those without dynamic change.~      Alternative hypothesis:~      Symptomatic preterm labor patients, with normal initial cervical length(>3cm), who exhibit~     dynamic cervical change deliver at an earlier gestational age than those without dynamic~     change.~   "
248623|NCT00298467|"~     This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL~     who have relapsed or refractory disease. There will be 3 phases of this study: Induction,~     Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits~     in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as~     other testing. Patients who complete the Induction Phase may be eligible for additional~     MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete~     the Maintenance Phase with a response of stable disease or better will be followed every 2~     months for 1 year or until disease progression. The purpose of this study is to determine~     objective response rate at Day 50 in patients with relapsed or refractory classic systemic~     ALCL or primary cutaneous ALCL treated with MDX-060. Other objectives will be evaluated.~   "
248624|NCT00298454|"~     Intensive care patients with multiple organ dysfunction syndrome often show renal failure~     with the need for hemofiltration. Resolving renal failure after cessation of hemofiltration~     may or may not be accompanied by oliguria. Whether or not the administration of diuretics at~     that moment is appropriate is not known. The study randomises between furosemide or placebo~     when hemofiltration is stopped. Study endpoint is recovery of renal function.~   "
248625|NCT00298441|"~     The purpose of this study is to determine whether the frequency of intravenous iron~     administration has an effect on anemia correction and oxidative stress formation in~     hemodialysis patients.~   "
248632|NCT00298350|"~     The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137~     relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of~     combination antiretroviral regimens in subjects who have failed, or are failing, protease~     inhibitor therapy.~   "
248633|NCT00298337|"~     The aim of the study is to find out if allergic diseases can be prevented buy giving~     probiotic bacteria to pregnant mothers and their newborn infants~   "
248634|NCT00298324|"~     The purpose of this study is to determine whether the response to treatment for extensive~     chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside~     cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and~     prednisone alone.~   "
248626|NCT00298428|"~     The risk of thrombotic complications after implantation of drug-eluting stents (DES) may be~     increased in patients with diabetes mellitus (DM) or metabolic syndrome (MS). It is~     recommended that all patients take an association of aspirin and clopidogrel for several~     months after DES implantation to reduce this risk. However, the biological efficacy of~     current antiplatelet therapies has not been studied prospectively and specifically in DM or~     MS patients.~      Our aim is to study the biological efficacy of an association of aspirin and clopidogrel (600~     mg loading dose followed by 75 mg maintenance dose) using an assay measuring ex vivo~     shear-induced platelet aggregation (SIPA), along with other assays measuring platelet~     activation and aggregation, in patients with DM, MS, or no DM/MS.~      Patients with stable coronary artery disease and successful DES implantation in native~     coronary arteries will be eligible. They will be stratified at entry according to their~     metabolic status (DM, MS, or no DM/MS). Measurements will be performed 6-24 hours after~     clopidogrel loading dose (acute effects) and 4 months later under clopidogrel maintenance~     dose (chronic effects).~      Study end-points:~      A. Primary biological end-point: To compare SIPA levels in DM vs. MS vs. no DM/MS patients.~      B. Secondary biological end-points:~        -  To compare the results of other tests of platelet aggregation/activation in DM vs. MS~          vs. no DM/MS patients.~        -  To compare the acute (6-24 hours after clopidogrel loading dose) and chronic (4 months~          later) results of the above mentioned tests. These comparisons will be performed in the~          overall population and in each group (DM, MS, no DM/MS).~      C. Secondary clinical end-points: To study the relationship between SIPA levels (and the~     other tests of platelet aggregation/activation) and the occurrence of:~        -  Periprocedural myocardial infarctions~        -  Major adverse cardiac events (cardiovascular death, myocardial infarction or~          ischaemia-driven target vessel revascularization) at 4 and 12 months after stent~          implantation.~      We, the researchers at Assistance PUBLIQUE - HOPITAUX de Paris, anticipate our study may help~     improve our knowledge of the efficacy of current antiplatelet therapies in DM and MS patients~     treated with DES.~   "
248627|NCT00298415|"~     The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIB/IV of~     elderly people, are to manage a monochemotherapy. Paclitaxel in association with carboplatin~     is feasible in elderly patients and the retrospective analysis of two studies of the~     comparing SWOG, one this association with that of cisplatine and vinorelbine and the other~     cisplatine only with cisplatine and vinorelbine, showed among 117 the 70 years old patients~     and more, the absence of significant difference of survival and toxicity compared to the~     younger patients. The study recently published of Lilenbaum and Al shows that among patients~     with bad PS, association carboplatine and paclitaxel do better than the paclitaxel only. The~     paclitaxel managed in weekly form is likely of a better activity by exposing the cancerous~     cells in a repeated way with shorter intervals without allowing the emergence of resistant~     clones and by allowing an increase in the intensity of amount. This mode of administration~     appeared at the same time effective and tolerated very well among patients of more than 70~     years. The weekly association of carboplatin and paclitaxel was tested in phase II and showed~     a rate of response of 14% and one survival 1 year from 31% a randomized test (not dedicated~     to the old person) of phase II to 3 arms was led by Belani et al.. The best combination of~     carboplatine + paclitaxel weekly proved to be that associating paclitaxel 100mg/m² 3 weeks~     out of 4 and carboplatine AUC 6 in J1 with J1 = J29. A test of phase II dedicated the 70~     years old to patients and more was carried out in France taking again this association~     carboplatine (AUC 6) every 4 weeks and paclitaxel weekly (90 mg/m² J1, J8 and J15). This test~     having included 51 patients highlighted a median of 10,42 months survival (IC 95%:~     7,29-17,05)~   "
248628|NCT00298402|"~     Cigarette smoking causes an increase in inflammation in the lungs. In about 20% of smokers~     this inflammation leads to damage in lungs including making holes in the lung tissue. This~     damage can not be repaired and these people find it very difficult to breathe. One of the~     problems with this disease called chronic obstructive pulmonary disease, or COPD for short,~     is that by the time patients visit their doctor with symptoms, the damage has already been~     done. At the moment, there is no way to predict which smokers will go on to develop COPD. The~     aim of this research is to look at smokers who breathe normally and use an imaging technique~     called a CT scan, to look at their lungs in more detail. Some of these people will have spots~     on their scan which may be caused by inflammation. We want to look at the cells at these~     spots to see if they make more proteins and enzymes that cause lung damage when compared to~     people that do not have these spots. We would then be able to predict which smokers are~     likely to develop COPD and treat them early before they have damaged their lungs.~   "
248629|NCT00298389|"~     Patients with chronic obstructive pulmonary disease (COPD) that have frequent chest~     infections are the patients most likely to become worse over time. Why these people are more~     susceptible to chest infections is not known. One reason might be that the white cells in~     their lungs called macrophages do not work properly. Normally, these cells remove all the~     debris inhaled into the lung. This can also include bacteria. In patients with COPD, these~     macrophages are not able to remove these particles. The research question addresses why this~     happens~   "
248630|NCT00298376|"~     This study aims to determine if there is a link between cow’s milk allergy in infants and~     regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance~     after 12 month avoiding food and persistent in others.~      Cow’s milk allergy is evaluated by basophils activation test, T cells activation test,~     specific humoral response (IgA, IgE, IgG) in allergic infants before and after 12 month~     avoiding food, before and after low dose milk exposure, before and after oral challenge.~      Number and function of regulatory T cells and microflora composition are measured at the same~     time.~      Allergic infants are compared to age matched control group.~   "
248631|NCT00298363|"~     This study was designed to evaluate and compare the safety and tolerability of tenofovir~     disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of~     hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating~     adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating~     reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores,~     reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes,~     development of drug-resistant mutations, and generation of antibody to virus.~      A maximum randomized treatment duration of 168 weeks was planned. Since subjects with~     decompensated liver disease were enrolled into this study, it was necessary to provide early~     intervention strategies if profound viral suppression was not expeditiously achieved. For~     this reason, subjects with a decrease in plasma HBV DNA from baseline of < 2 log_10 copies/mL~     and plasma HBV DNA > 10,000 copies/mL (or plasma HBV DNA > 1,000 copies/mL for subjects who~     entered the study with HBV DNA < 10,000 copies/mL) at Week 8 had the option to start~     open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who~     had plasma HBV DNA levels remaining > 400 copies/mL (confirmed) at or after 24 weeks of~     treatment could have been unblinded at the investigator's discretion for selection of~     alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was~     permanently discontinued, immediate initiation of another anti-HBV regimen was strongly~     recommended.~   "
248638|NCT00298272|"~     The primary objective of this study was to evaluate the tolerability and safety of rituximab~     in combination with methotrexate (MTX) and etanercept or adalimumab in participants with~     active rheumatoid arthritis (RA). The secondary objective was to explore the efficacy of~     rituximab in combination with MTX and etanercept or adalimumab in participants with active~     RA.~   "
248639|NCT00298259|"~     Background: Fracture of several ribs in more than one place as the result of trauma, leads to~     paradoxical movement of the chest wall and ventilatory failure. The mainstay of management in~     these patients has traditionally been analgesia and positive pressure ventilation to splint~     the chest wall and allow healing of the ribs to begin. However, this management option leads~     to prolonged intensive care unit (ICU) stay with increasing complication rates as patients~     remain on a ventilator for prolonged periods. Patients often remain on a ventilator for two~     to three weeks while waiting for enough rib healing to provide sufficient chest wall~     stability to allow the patient to take over all their breathing themselves. Until that time,~     patients are at risk of pneumonia and sepsis and other complications. Long term disabilities~     which have been reported in these patients include ongoing pain syndromes, inability to~     return to work, particularly manual type labour and cosmetic chest wall deformities.~      An alternative treatment strategy is to operatively fix the ribs. By fixing the ribs~     operatively, the patient no longer requires internal pneumatic stabilization (provided by~     mechanical ventilation) and can be weaned from the ventilator within days rather than weeks.~     This can potentially lead to earlier discharge from the intensive care unit, and an avoidance~     of the multiple complications which arise in the ventilated patient. Rib fixation may also~     lead to less pain and deformity, improved mobility in the post injury phase and earlier~     return to work.~      Hypothesis: that early operative fixation of ribs in patients presenting with flail chest~     secondary to trauma will result in less mechanical ventilatory requirements, earlier~     discharge from the intensive care unit and lower rate of complications associated with~     prolonged mechanical ventilation. This will lead to cost savings in the treatment of these~     patients.~   "
248640|NCT00298246|"~     The purpose of this study is to learn more about autism and its subtypes. Autism is a~     developmental disorder in which children have problems with communication and social skills~     and display restricted interests and repetitive behaviors.~      This study has several goals. One aim is to look at types of autism that are known, such as~     the regressive subtype, (where skills are lost). We will explore whether there is a unique~     change in immune functioning related to this subtype. Another aim is to serve as one of the~     sites that will pilot a larger natural history study, entitled Autism Phenome Project. The~     goal is to further understand autism by identifying other subtypes.~      We will look at several types of medical issues that may be related to autism, including~     immunologic problems. Children will be followed over the course of several years. We aim to~     capture medical problems that may be related to autism as they develop, and study outcomes in~     areas such as behavior and language, in order to explore known and new subtypes of autism.~      Normally developing children (aged 1) with autism (age 1, and developmental delays other than~     autism (age 1), may be eligible for this study.~      Depending on each child's study group and age, participants may undergo the following tests~     and procedures:~      Baseline Visit~        -  Medical and developmental history, physical examination, psychological, cognitive and~          medical tests to assess symptoms of autism or other developmental disorders, photographs~          of the child's face, collection of hair, urine and baby teeth samples. If available,~          hair samples from the baby's first haircut and from the biological mother's hair are~          also collected.~        -  Overnight electroencephalogram (EEG): A special cap with electrodes is placed on the~          child's head to measure brain waves (brain electrical activity) while the child sleeps~          in the hospital overnight. Healthy volunteers do not undergo this procedure.~        -  Magnetic resonance imaging (MRI) scan: The child stays in the scanner, lying still for~          10 to 15 minutes at a time. Since it may be difficult for the child to lie still, the~          test may be scheduled for a time when the child is likely to be sleepy, or the child may~          be sedated.~        -  Lumbar puncture (for children in the autism). This test and the MRI may be done under~          sedation.~      Follow-Up Visits~      Follow-up visits are scheduled at different intervals, depending on study group, age and~     aspect of the study the child is enrolled in. The visits include a short interview session~     with the child's caregiver and assessment of the child's development and behavior. Some of~     the assessment measures used during the baseline examination are repeated, including symptoms~     ratings, behavioral tests and a blood test. For some children, the final visit will include~     repeats of the medical procedures.~   "
248641|NCT00298233|"~     Influenza, also known as the flu, is a contagious respiratory illness caused by influenza~     viruses. The illness can range in severity, from mild to severe to even death, and it causes~     an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years,~     there have been increasing numbers of human cases of avian influenza, or bird flu. This trend~     may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian~     influenza virus that can easily spread from person to person. Oseltamivir is an antiviral~     medication that is used to treat people with uncomplicated human influenza, and it may be~     effective in treating people with either severe human influenza or avian influenza. The~     purpose of this international study is to compare standard-dose oseltamivir versus high-dose~     oseltamivir for treating people who are hospitalized with severe human influenza or avian~     influenza.~   "
248642|NCT00298220|"~     The aim of the study is to test whether or not a tailored multi-component intervention~     program to increase the activity of general practice teams in the prevention of hazardous and~     harmful alcohol consumption results in increase advice giving rate to patient with hazardous~     and harmful alcohol consumption and a better patient outcome in terms of hazardous and~     harmful alcohol consumption.~      The primary objectives of the proposed study are:~        1. to test the (cost) effectiveness of a tailored multi-component implementation program to~          engage general practices (i.e. GPs, nurse practitioners or practice nurses/assistants)~          in the prevention of hazardous or harmful alcohol consumption, changing both providers'~          advice giving behaviour and patients' alcohol consumption~        2. to identify predictors of effect~        3. to examine whether or not the implementation of a tailored multi-component~          implementation program to engage general practice in the prevention of hazardous or~          harmful alcohol consumption is feasible.~   "
248643|NCT00298207|"~     High blood pressure (hypertension) is one the most common and serious chronic diseases among~     Americans, especially among the African Americans. The purpose of this study is to explore~     the effect six month long walking intervention on blood pressure in adult African American~     with a newly diagnosed high blood pressure (hypertension). The hypothesis is that the group~     with encouragement to walk extra 30 minutes a day for 5-7 days a week may lower their blood~     pressure compared to the control group without the encouragement.~   "
248644|NCT00298194|"~     To assess in subjects with and without functional dyspepsia the effects of Z-338 on:~        1. Type and severity of symptoms a standardized nutrient challenge~        2. The gastric nutrient distribution and gastric emptying of a standardized nutrient~          challenge~        3. The association of the above with the manifestations of symptoms and symptom pattern~   "
248645|NCT00298181|"~     Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced~     kidney injury and resultant DGF. PSGL-1 is a ligand for P-, E-, and L-selectin. It has been~     reported that that YSPSL (rPSGL-Ig) blocks P-selectin and, to a lesser degree, E- and~     L-selectin. Both sPSGL-1 and YSPSL (rPSGL-Ig) have been shown in animal models to reduce both~     cytokines and tissue damage associated with ischemia reperfusion and to improve renal~     function post-transplant. Therefore, the current phase I/II clinical study is designed to~     assess the safety and efficacy of YSPSL (rPSGL-Ig) in preventing DGF in patients undergoing~     cadaveric kidney transplants and to determine a dose for future pivotal studies.~   "
248660|NCT00297973|"~     Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in~     patients with hypertension and at least three other cardiovascular risk factors (including~     diabetic patients) seen in private practice and randomized to either Caduet or usual care.~   "
248646|NCT00298168|"~     Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced~     kidney injury and resultant delayed graft function (DGF). PSGL-1 is a ligand for P-, E-, and~     L-selectin. It has been reported that YSPSL (rPSGL-Ig) blocks P-selectin and, to a lesser~     degree, E- and L-selectin. Both sPSGL-1 and YSPSL (rPSGL-Ig) have been shown in animal models~     to reduce both cytokines and tissue damage associated with ischemia reperfusion and to~     improve renal function post-transplant. Therefore, the current phase I/II clinical study is~     designed to assess the safety and efficacy of YSPSL (rPSGL-Ig) in preventing DGF in patients~     undergoing cadaveric kidney transplants and to determine a dose for future pivotal studies.~   "
248647|NCT00298155|"~     Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the~     second leading cause of cancer-related mortality. More than 230,000 men will be diagnosed~     with prostate cancer in the USA this year and more than 30,000 will die of this disease.~      Androgen deprivation, the elimination of testosterone and its active metabolites, remains the~     single most effective intervention available for the treatment of advanced prostate~     carcinoma. This is usually achieved by surgical removal of the testes (orchiectomy), by~     suppressing production of testosterone (LHRH agonists) and/or by blocking the androgens at~     receptor sites (antiandrogens). Unfortunately, androgen suppression does not cure the~     disease. Most patients progress within 0-5 years, and all patients ultimately progress if the~     cancer is not eliminated during initial therapy (usually prostatectomy or radiation).~      Hormone suppression treatment eliminates the detectable levels of testosterone in the blood.~     However, the testosterone levels in tissue remain high enough to stimulate androgen~     receptors. Overexpression of androgen receptors is present in all cell lines which~     demonstrate androgen independence, i.e., are resistant to androgen-suppressive therapy.~      Approximately 95% of testosterone is supplied by the testes, with the remaining 5% supplied~     by the adrenal glands. The presumption that standard androgen deprivation achieves the~     optimal level of androgen suppression for patients is based on the levels of androgen which~     result from orchiectomy. However, because adrenal androgen levels are unaffected by standard~     modes of androgen deprivation, 5% of the body's testosterone remains despite hormone therapy.~      The hypothesis of this study is that more effective suppression of the androgen axis through~     elimination of adrenal androgens and more effective suppression of testosterone metabolites~     will lower intraprostatic androgen levels, minimizing activation of the androgen receptor and~     augmenting natural cell death (apoptosis). The investigators propose to test this hypothesis~     by administering neoadjuvant (pre-surgery) androgen deprivation therapy of different types~     before prostatectomy for patients with clinically localized prostate cancer. The~     investigators will assay serum and intraprostatic androgen levels, while assessing relative~     levels of apoptosis of normal and malignant tissue.~   "
248648|NCT00298142|"~     The management of headache disorders is too often based upon trial and error or on personal~     beliefs and opinions. Seldom it is based on scientific arguments. Therefore the~     identification of prognostic patient characteristics is mandatory as this will lead to a more~     precise referral of headache patients.A prospective cohortstudy is designed to identify these~     prognostic patient characteristics. After testing, 186 headache patients (migraine, tension~     type headache and cervicogenic headache) will be randomly allocated to one of two treatment~     groups. Testing includes the fulfillment of questionnaires (Headache Diagnosis Questionnaire,~     Headache Inventory Questionnaire and the Headache Impact Test) and physical tests (Thermal~     Stimuli, Cervical Spine examination and Pressure Algometry). Treatment groups are a usual~     care group (administered by a medical doctor) and a usual care plus physio-/ manual therapy~     treatment. After six weeks of treatment subjects will complete the headache inventory list~     and the Headache Impact Test a second time. The perceived effect will be registered allowing~     the distinction between responders (positive effect) and non-responders (no effect or worse).~     Logistic regression-analysis will be used to identify the specific patient characteristics of~     the responders and the non-responders. Secondly the additional value of the physio-/ manual~     therapy intervention will be examined. Follow-up measurements up to 52 weeks are provided.~   "
248649|NCT00298129|"~     Many patients with chronic renal disease show a loss of the nocturnal decline of blood~     pressure (non-dipper). However, the mechanism is not yet fully understood. We evaluate~     24-hour blood pressure in patients with chronic renal disease using an ambulatory blood~     pressure monitoring device (A & D TM2425). We also analyze the power spectrum of heart rate~     variability as an index of autonomic cardiovascular modulation using the same device.~   "
248650|NCT00298116|"~     The overall hypothesis to be tested is: women with the molecular phenotype of highly skewed X~     chromosome inactivation are at increased risk of spontaneous abortion.~   "
248651|NCT00298103|"~     The purpose of this study is to review patients with E. coli infections at UPMC from January~     1, 2004 to December 31, 2005 to determine if these infections have arisen in the community~     rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be~     devastating if they were associated with bloodstream infection, such as sometimes accompanies~     urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates~     coming from the community.~   "
248652|NCT00298090|"~     Measuring tissue oxygen saturation (St02) in the thenar eminence is emerging as a measurement~     of resuscitation. However, no study to our knowledge has evaluated the effects of an arterial~     line in the radial artery supplying this muscle bed on St02. This study will attempt to~     address the interaction between an arterial line and St02 monitoring in the thenar eminence.~     As most patients who require aggressive resuscitation will have an arterial line, it is~     important to understand what if any impact this will have on St02 in the same extremity.~   "
248653|NCT00298077|"~     The study will identify patients with infections commonly observed in transplant recipients,~     describe the epidemiology of their infection, study the risk factors associated with various~     infections and examine strategies of early diagnosis and prevention of infection~   "
248654|NCT00298064|"~     The Tissue Repository will search for cases, pull slides, Paraffin-embedded tissue (PET)~     blocks.~   "
248655|NCT00298051|"~     The aim of the study was to determine whether delayed umbilical cord clamping, as compared to~     early umbilical cord clamping, improves infant iron status at 6 months of age.~   "
248656|NCT00298038|"~     The purpose of this study is to determine if the study drug is safe and effective in~     preventing Hepatic Encephalopathy (HE).~   "
248657|NCT00298025|"~     To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and~     Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing~     ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal~     gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral~     contraceptives pill (OCP) for cycle programming.~   "
248658|NCT00298012|"~     The goal of this study is to evaluate the efficacy of oral methotrexate for the treatment of~     active axial spondyloarthritis (early ankylosing spondylitis or spondyloarthritis with~     sacroiliitis). Efficacy will be measured by reduction in the signs and symptoms of active~     spondyloarthritis including effects on back pain and stiffness, range of motion in the spine,~     physical function, quality of life and incidence of arthritis, enthesitis and anterior~     uveitis.~   "
248659|NCT00297986|"~     In this study the investigators aimed to study the ventilatory performance of different~     interfaces during NPPV delivering.~   "
248664|NCT00297921|"~     Prospective, nonrandomized, noncomparative, open-label, multicenter, 2-stage clinical study~     designed to determine the overall response (combined complete remission, complete remission~     with incomplete blood count recovery, partial remission, or blast response) rate following~     tandutinib therapy in 2 groups of patients with newly diagnosed Acute Myelogenous Luekemia.~   "
248665|NCT00297908|"~     Ethanol based hand sanitizers do not raise blood alcohol levels to a measurable amount. This~     study will determine to what extent, if any, heavy use of ABHS changes blood alcohol levels.~   "
248666|NCT00297895|"~     Subjects must be diagnosed with melanoma. All subjects receive sentinel lymphadenectomy. If~     the subject is sentinel node positive and meets study requirements, the subject is randomized~     to receive either (1) completion lymphadenectomy (2) observation with nodal ultrasound.~     Subjects are then followed for 10 years.~   "
248667|NCT00297882|"~     This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria~     combination drugs (ACTs)for treatment of children aged 1-10 years in different locations in~     Cameroon. Randomized clinical trials will provide local data on the safety of the test drugs,~     and on putative marker mutations of the development of resistance to ACT. The study will~     involve three centres, namely, Banso (Guinea-Savannah region), Limbe(Littoral Forest), and~     Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of~     Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be~     determined using a WHO standardised 28 day protocol. Safety will be monitored through~     clinical examination, and biochemical and haematological indices. Molecular markers of~     artemisinin resistance will be investigated by molecular sequencing and comparison of~     parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections~     will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on~     generation of gametocytes will be determined from gametocyte carriage rates measured by~     microscopy.~   "
248668|NCT00297869|"~     The subjects in this study are physicians working in the Wishard Emergency Department. The~     purpose of this study is to measure the extent to which information technology~     (i.e.-computers) improves emergency department care. The objective of our study is to~     evaluate the use of informatics in the emergency department and specifically to determine if~     computer reminder systems: 1) reduce the number of unsafe medications prescribed to older~     adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase~     influenza immunization of eligible older patients in the emergency department.~      Interventions: The interventions in this study are computer reminders. When releasing~     patients from the emergency department, physicians currently write all release orders,~     including prescriptions, on a computer order entry system that is linked to the Regenstrief~     Medical Record System. The computerized order entry system will be programmed so that~     physicians randomized (randomly placed) into the intervention group, the group that will~     receive the intervention, they will receive one of three types of reminders:~        1. The medication prescribed is generally considered unsafe for use in older patients. The~          reminder will then list appropriate alternatives for this medication.~        2. The dose of the prescribed medication is excessive and should be adjusted for the~          patient's creatinine clearance (or kidney function).~        3. This patient may be eligible for influenza vaccination.~      The physician will then choose to order or disregard the recommendation. The computer system~     will automatically record what the physician selected to do. The general outcome of interest~     is the extent to which the electronic reminders successfully improved physician practice in~     the emergency department setting. This outcome will be compared to physicians who were~     randomized to the group that did not receive the reminders (the control group).~   "
248669|NCT00297856|"~     Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and~     well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare~     outcomes in a large population cohort. The Protocol Posting has been updated in order to~     comply with the FDA Amendment Act, Sep 2007.~   "
248670|NCT00297843|"~     Allergic Rhinitis is an inflammatory disease which causes an influx of inflammatory cells and~     cytokines into the nasal mucosa. These biomarkers can also be found in the nasal secretions.~     The evaluation of these inflammatory biomarkers is of great interest as this could lead to a~     concept of measuring the efficacy of anti-allergic treatments by assessing the changes in~     nasal biomarkers after allergen challenge. To use this model as an assessment of~     pharmacodynamics it is crucial to evaluate the specificity and reproducibility of cellular~     and cytokine levels in the nasal secretions after allergen provocations.~      In a 2 part repeated measurement design 20 patients with allergic rhinitis and 20 healthy~     subjects will undergo two 4-hour pollen exposures in an interval of 21 days.~      The aim of this study is to explore the cellular and cytokine levels this allergen challenge~     will induce in nasal secretions and to assess if an increase in those inflammatory biomarkers~     is specific to the patient subgroup and whether the results are reproducible after the second~     allergen challenge.~   "
248671|NCT00297830|"~     The purpose of this study is to compare the effectiveness and safety of zoledronic acid with~     alendronate in the prevention of bone loss after organ transplantation. Zoledronic acid is~     given as a single intravenous infusion. Alendronate is given as a weekly pill. Both are~     expected to be very effective, but it is not known which one will work best.~   "
248672|NCT00297817|"~     The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B~     meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11~     to 18 years.~   "
248673|NCT00297804|"~     The clinical investigation is an international, prospective, multi-center, double-blind,~     randomized safety and efficacy trial. The purpose of this study is to evaluate the safety and~     effectiveness of the TAXUS(TM)Stent System with 1µg/mm2 (loaded drug/stent surface area) of~     paclitaxel incorporated into a moderate rate-release formulation of triblock copolymer~     carrier system in patients with a higher risk of target lesion revascularisation and~     restenosis.~   "
248674|NCT00297791|"~     COLOR II is a randomized, international, multi center study comparing the outcomes of~     laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent.~     Clinical and operative data will be collected centrally in the coordinating centre in~     Halifax, Canada. Quality of life and costs will be assessed on a national basis.~   "
248689|NCT00297583|"~     The primary objective of the study was to compare the effect of insulin glulisine, insulin~     lispro and unmodified human insulin on endogenous glucose production during euglycemic~     glucose clamps using stable labeled glucose in type 1 diabetic subjects.~      The secondary objectives of the study were to assess:~        -  the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma~          nonesterified free fatty acids (NEFA) and glycerol levels~        -  the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma~          lactate levels~        -  the safety and tolerability of insulin glulisine in comparison to insulin lispro and~          unmodified human insulin.~   "
249074|NCT00292357|"~     Bone marrow cells were previously shown to enhance wound healing in experimental diabetes. In~     this pilot study, patients with chronic diabetic ulcers not healing under conventional~     therapy, will be treated with local application of autologous bone marrow cells.~   "
248675|NCT00297778|"~     Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the~     brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the~     brain (nerve cells) to control and harmonize muscle movements. Consequently, the main~     manifestations of the disease affect movement and include tremor, muscular rigidity, slowness~     in performing movements and loss of balance.~      However, the disease affects also other, non motor functions and may cause other disorders,~     such as depression. Depression may be a reaction to the disability caused by the disease, but~     many studies show that depression is more common in PD than in other chronic debilitating~     illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is~     also used in brain circuits involved in the experience of pleasure, and loss of pleasure in~     daily physical or social activity is one of the key manifestations of depression.~      The objective of the study is to assess whether pramipexole, at doses approved for the~     treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in~     PD patients.~      Also data on the safety of the product in the disease will be collected.~   "
248676|NCT00297765|"~     A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of~     kidney transplant patients.~   "
248677|NCT00297752|"~     The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres.~     Scarring of the face as a consequence of burns will often have a detrimental effect on~     function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the~     best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is~     little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing.~      In clinical practice good results are felt to be achieved by treatment of facial burns with~     flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is~     compared to flammazine, a current alternative of care. The efficacy of treatment will be~     assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in~     terms of number of patients requiring surgery and functional and aesthetic outcome.~      Apart from medical outcome, this study offers the opportunity to study psychosocial problems~     associated with facial defects. It is still an unresolved question whether facial scarring~     causes more or different psychosocial problems. Therefore, self-esteem and quality of life~     will be examined over time, in relation to depression, posttraumatic stress symptoms and~     other factors, such as coping style and social support.~      By evaluating the efficacy of different treatment strategies, we aim to optimise the standard~     of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial~     impact of facial injury. With these results psychosocial professionals will be able to focus~     on persons at risk and to be better able to meet a patient's personal needs.~   "
248678|NCT00297739|"~     Primary objectives:~        1. To assess the short-term efficacy of risperidone augmentation for treatment-resistant~          aggression in children with ADHD.~        2. To assess the short-term safety and tolerability of risperidone augmentation in the same~          group of subjects.~   "
248679|NCT00297726|"~     This study will examine the efficacy of the Arthritis Self Managemnet Program (ASMP)and~     determine changes in health resource utilization after completeing the ASMP program.~   "
248680|NCT00297713|"~     ALTU-238 is a long acting crystalline formulation of recombinant human growth hormone (rhGH)~     that is being developed for the treatment of growth hormone deficiency in adults and~     children. ALTU-238 is designed to require fewer injections than the currently available~     formulations of rhGH.~   "
248681|NCT00297700|"~     Our goal is to test a dentist-hygienist team intervention to help dental patients quit~     smoking and determine if it can be effectively and cost-effectively implemented and~     sustained.~      Staff in half of the HMO's 14 large dental facilities will be trained to provide brief~     cessation advice and assistance and to encourage smokers to talk by phone with a tobacco~     counselor before they leave the dental office. Phone counselors will provide brief~     counseling, assess stage, and offer a full list of cessation services. The Active Referral~     intervention strategy is both practical and innovative, as it takes advantage of available~     resources; efficiently distributes intervention activities between dentists, hygienists, and~     counseling specialists; and could be delivered in individual, small, or large dental~     practices. This intervention is provided as part of routine care to all patients seen for~     annual dental and periodontal exams.Consented patients will receive a short phone survey~     shortly after the exam to assess smoking status, satisfaction with delivery of support~     services,and satisfaction with intervention. Consented patients in treatment and control~     facilities will be surveyed by phone at one year to re-assess smoking status and satisfaction~     with services.~   "
248682|NCT00297687|"~     To determine the safety & immunogenicity of a potential vaccine against meningococcal B~     disease~   "
248683|NCT00297674|"~     The aim of this clinical trial is to clarify the clinical efficacy of clarithromycin as~     immunotherapy for the management of septic syndrome by ventilator-associated pneumonia.~   "
248684|NCT00297661|"~     Context: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal~     stents, reduce the risk of restenosis. It is unclear whether there are differences in safety~     and efficacy between the two types of drug-eluting stents.~      Objective: To determine differences in safety and efficacy between sirolimus and paclitaxel~     eluting stents.~   "
248685|NCT00297648|"~     The aim of the study will be to investigate the effect of certolizumab pegol on the~     intestinal mucosa in active Crohn's disease.~   "
248686|NCT00297635|"~     This study will help determine whether the use of a wireless glucose meter and and an~     internet-based automated diabetes management system to organize blood glucose values will~     help improve glucose control during the start of continuous subcutaneous insulin infusion~     therapy by an insulin pump device in patients with type 1 diabetes. Outcome measures to be~     determined include an assessment of glucose excursions, overall glucose control, health care~     team staff and patient time required and a satisfaction survey.~   "
248687|NCT00297609|"~     Computerized physician order entry with clinical decision support system CPOE+CDSS)completely~     eliminated errors in filling in the resuscitation medications order forms and significantly~     reduced time to completing the forms in a pediatric critical care department (PCCD).~   "
248688|NCT00297596|"~     This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second~     line therapy in patients with stage IV, metastatic breast cancer~   "
248690|NCT00297570|"~     The study is controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+~     CML) patients with complete cytogenetic response after more than one year of imatinib~     therapy. The aim is to explore a possible benefit in the addition of peg-interferon (Peg-IFN)~     to imatinib, in terms of the rate of achievement, molecular remission, and response duration.~   "
248691|NCT00297557|"~     Comparison of single time point with dual time point PET imaging in the accuracy of~     diagnosing active lymphoma. Biopsy results or clinical/radiological progression will be used~     in conjunction with the PET data.~   "
248692|NCT00297544|"~     We are investigating the chronic effect of daily assumption of Viagra on the blood vessels~     function in patients with impotence. The study will include 2 groups: 1- patients with~     multiple risk factors, e.g. hypertension 2- patients with no cardiovascular risk factors~   "
248693|NCT00297531|"~     This study is to determine whether scaling and root planing (SRP) followed by photodynamic~     disinfection results in improved outcomes that persist over time in adults with chronic~     periodontitis when compared with subjects with SRP alone.~   "
248694|NCT00297518|"~     This study is to determine whether scaling and root planning (SRP) followed by photodynamic~     disinfection results in improved outcomes that persist over time in adults with chronic~     periodontitis when compared with subjects with SRP alone.~   "
248695|NCT00297505|"~     The purpose of this study is to compare the effects of citalopram versus placebo given in the~     context of contingency management for cocaine dependence.~   "
248696|NCT00297492|"~     This study tests whether stopping smoking by gradually cutting down first is more or less~     successful than stopping abruptly. We hypothesize that stopping by gradually cutting down~     first will produce more abstinence than stopping abruptly.~   "
248697|NCT00297479|"~     The goal of this behavioral research study is to create and study a Mindfulness-Based~     Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus~     attention on being in the here and now. It can be learned through training in how to~     control one's attention. It is usually taught through meditation. The overarching goals of~     the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and~     effects posited to mediate MBAT's impact on abstinence.~   "
248698|NCT00297466|"~     The purpose of this study is to determine whether a brief, focused intervention in the~     hospital emergency department is effective in helping adults quit smoking.~   "
248699|NCT00297453|"~     The study is designed to evaluate and compare the efficacy and cost effectiveness of 3~     smoking cessation treatments with HIV-positive cigarette smokers. The treatments include~     face-to-face individual counseling, a computer-Internet-based self-help treatment and a~     self-help manual treatment.~   "
248700|NCT00297440|"~     We seek to: 1) conduct the formative work to adapt the cessation materials and exercise~     protocol from focus on adult women to adolescent girls, and 2) conduct a small randomized~     pilot trial to determine the preliminary efficacy of the intervention in a sample of~     adolescent girls. Therefore, this study, will serve as a pilot for a larger clinical trial.~     Successful smoking cessation in adolescent girls could contribute to the future reduction of~     chronic disease morbidity and mortality in this group.~   "
248701|NCT00297427|"~     This research study will evaluate the effectiveness of acupuncture in decreasing urinary~     incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture~     sessions over 6 weeks. We will compare the effectiveness of acupuncture and sham (placebo)~     acupuncture (a procedure in which the needle feels like it penetrates the skin, but is not~     actually inserted into the body) on the frequency and volume of involuntary (accidental)~     urine loss after completing the intervention, and again one month later. Individuals~     participating in this study will be randomly assigned to receive either the actual or sham~     acupuncture. Randomization means being assigned by chance, similar to flipping a coin. Study~     participants will not know which group (actual or sham acupuncture) they were assigned to~     until one month after completing the 6-weeks of treatment. The sham acupuncture needles look~     similar to the real acupuncture needles and feel like they penetrate the skin, but do not~     actually do so. If individuals are assigned to the sham acupuncture group, they will be~     eligible to receive the actual acupuncture one month after completing the sham acupuncture if~     they wanted to. All individuals will be followed for 6 months after completing the~     acupuncture treatments.~   "
248702|NCT00297414|"~     The purpose of the study is to collect data of patients who were randomized (assignment of~     study medication by chance) and treated in 3 previous studies of galantamine (CR003145,~     CR002014 and CR005947) for the treatment of mild cognitive impairment (isolated memory~     impairment). This data were not recorded during the course of these 3 previous studies.~   "
248703|NCT00297401|"~     Protein kinase C (PKC), an enzyme in the body, has been implicated in the process of diabetic~     microvascular complications. The purpose of this study will be to evaluate the renal~     hemodynamic and peripheral vascular effects of PKC inhibition with ruboxistaurin mesylate (an~     inhibitor of PKC) in patients with Type 1 diabetes mellitus and evidence of early~     nephropathy. In this pilot study, 21 patients with type 1 diabetes were planned to be~     randomized to LY333531 or placebo in a 2:1 fashion, after an initial period of testing. After~     8 weeks of study drug, patients were retested.~   "
248704|NCT00297388|"~     The purpose of this study is to assess the time for patients to relapse when switched from an~     oral antipsychotic to one of two doses of long-acting risperidone injection (shots).~     Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.~   "
248705|NCT00297375|"~     The purpose of this study is to evaluate the effectiveness and safety of tramadol~     HCl/acetaminophen as a pain medication compared with placebo in the treatment of acute pain~     from a migraine headache. Although tramadol HCl/acetaminophen is approved to treat acute~     pain, it is not approved for the treatment of acute pain associated with migraine headache.~     The study hypothesis is that tramadol HCl/acetaminophen is safe and effective as a pain~     medication in the treatment of acute pain associated with a migraine headache.~   "
248706|NCT00297362|"~     The purpose of this study is to evaluate the safety and effectiveness of galantamine~     hydrobromide in patients with Alzheimer's disease who have not received or have not responded~     to treatment with medication similar to galantamine hydrobromide.~   "
248707|NCT00297349|"~     The purpose of this observational study is to evaluate the safety of topiramate when used in~     combination with other medications for seizures in adults and children.~   "
248708|NCT00297336|"~     A 6-month, observational, post authorization safety study for the collection and evaluation~     of additional safety data on topiramate as a prophylactic treatment for migraines in adult~     patients. According to current European and international guidelines the safety and efficacy~     of drugs will be continuously monitored even after their approval and market circulation.The~     applicable methods of monitoring include: Observational studies, voluntarily reported adverse~     events, clinical trials of IV phase and Post Authorization Safety Studies ( PASS). Post~     Authorization Safety Studies (PASS) during the use of a product are a significant source of~     information regarding the action of the drug or a therapeutic method under the circumstances~     of every day clinical practice.~   "
248709|NCT00297323|"~     The purpose of this observational study is to evaluate the safety of topiramate in adults and~     children with epilepsy (or seizures) who have not received or have not responded to treatment~     with previous antiepileptic medication.~   "
248710|NCT00297310|"~     The purpose of this study is to evaluate two groups of kidney transplant recipients, to~     determine the proportion of patients that achieve therapeutic blood concentrations of~     tacrolimus by Day 3 after transplantation. Patients in one group will be treated with~     tacrolimus according current clinical practice. The other group will have a pre-transplant~     assessment of their tacrolimus blood level concentration that will be used to guide~     post-transplantation tacrolimus dosing. Tacrolimus is a medicine that slows down the body's~     immune system. For this reason, it works as an anti-rejection medicine.~   "
248711|NCT00297297|"~     Molecular gene profiling of fine-needle aspiration samples in addition to fine-needle~     aspiration cytology can improve the selection of patients with benign versus malignant~     thyroid nodules with improved sensitivity.~   "
248712|NCT00297284|"~     This study is being conducted in order to determine if the FDA-approved drug Modafinil can~     improve cognitive function in patients with lupus. Modafinil is currently being used to treat~     excessive sleepiness caused by certain sleep disorders. It has also been shown to improve~     attention and concentration in some people who don't have lupus or sleep disorders. This~     study hopes to determine if Modafinil can be used safely and effectively in lupus patients,~     and improve their quality of life. No medications currently exist for the treatment of~     lupus-associated cognitive dysfunction.~   "
248713|NCT00297271|"~     The purpose of the PRIME Study is to examine the current management and outcomes of patients~     with mild cognitive impairment or dementia. Approximately 4500 patients will be enrolled in~     this disease registry across 12 sites in Australia. Clinical, treatment, health status and~     economic data will be acquired over 3 years. The study will identify the relationships among~     demographic variables, prognostic features, geographic setting, treatment options and~     clinical, economic and health status (activities of daily living and caregiver impact)~     outcomes.~   "
248714|NCT00297258|"~     The purpose of this study is to evaluate the activity and tolerability of pazopanib in~     subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following~     standard therapies or for whom no standard therapy exists and to characterize the~     pharmacokinetics of pazopanib in this subject population.~   "
248715|NCT00297245|"~     The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect~     length of hospital stay, quality of life, the rehabilitation process, and work~     performance.However, there is no method to prevent the decline.Gastrodin,the active~     constituent of gastrodia elata, has been widely used for the treatment of paralysis,~     hemiplegia, headache, vertigo, and Alzheimer's disease. Gastrodin is safe. No severe~     side-effect has been observed in the treatment. We postulate that gastrodin would attenuate~     the causative parameters of cognitive dysfunction related to CPB and would be an effective~     drug to prevent the decline as a result.~   "
248716|NCT00297232|"~     The primary objectives for the initial treatment period of this study are to further evaluate~     the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions~     and immunogenicity following re-exposure to natalizumab and confirming the safety of~     switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS)~     therapies to natalizumab. The primary objective for the long-term treatment period of this~     study is to evaluate the long-term impact of natalizumab monotherapy on the progression of~     disability measured by Expanded Disability Status Scale (EDSS) changes over time.~   "
248717|NCT00297219|"~     The high rate of cardiovascular complications in the dialysis population cannot be explained~     by traditional cardiovascular risk factors. One of such factors proposed to contribute to the~     cardiovascular mortality in dialysis patient population is vascular calcification possibly~     resulting from disturbances of calcium-phosphate metabolism.~      The aim of this study is to assess the effects of treatment with dialysate containing 1.75 or~     1.5 mmol/L to 1.25 mmol/L calcium regarding coronary artery calcification and bone~     histomorphometry in hemodialysis patients.~   "
248718|NCT00297206|"~     Limited data are available on valaciclovir use in children and valaciclovir is not currently~     approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use~     in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An~     extemporaneous suspension formulation of valaciclovir has been developed to expedite the~     provision of benefits to children similar to those from administration of valaciclovir solid~     formulations in adults.~   "
248719|NCT00297193|"~     Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance~     or toxicity to conventional treatment.~      The purpose of this study is to determine whether there is a potential clinical benefit of~     hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous~     stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best~     clinical practice.~   "
248720|NCT00297180|"~     GW869682 causes glucose to be excreted in the urine. The purpose of this study is to see~     whether enough calories from glucose are excreted in the urine to cause weight loss.~   "
248721|NCT00297167|"~     The primary efficacy objective of this study is to compare the coefficient of fat absorption~     (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals)~     pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis~     (CF) and exocrine pancreatic insufficiency (EPI).~   "
248995|NCT00293514|"~     The purpose of this study is to compare the sealing efficacy and safety of TachoSil®~     (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary~     management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung~     malignancies with or without metastases.~   "
248722|NCT00297154|"~     A growing number of people in this country are overweight or obese. This is concerning as~     increasing weight has been shown to increase the risk of developing heart failure. However,~     there is also research to suggest that in people who already have heart failure, heavier~     people live longer. So, how does being overweight put a person at risk for heart failure, but~     once they have heart failure, protect them? There is no clear explanation for this dilemma.~      People who are obese commonly have other diseases, such as high blood pressure, high~     cholesterol, and diabetes, that increase the risk of developing heart disease. It is this~     group of diseases that is referred to as The Metabolic Syndrome. People with the metabolic~     syndrome also have increased levels of inflammation and clotting proteins in their blood~     stream. Current treatment of the metabolic syndrome involves using medications for~     cholesterol, blood pressure, and diabetes. Diet and exercise are also commonly recommended.~      Lifestyle intervention programs are programs that help people lose weight by changing their~     eating habits and exercise / activity routines. Weight loss and exercise have been shown to~     lower the risk of developing diabetes and improve diabetes control, improve cholesterol~     abnormalities, and lower blood pressure. These programs have not previously included heart~     failure patients, however.~      We hypothesize that using a lifestyle intervention program in addition to the usual~     medications for heart failure will result in improved symptoms of heart failure and control~     of the metabolic syndrome.~      This study will be the first research study to look at the use of diet and exercise in~     treating heart failure patients who are overweight / obese with the metabolic syndrome. The~     study will last 6 months. From this study we hope to learn whether diet and exercise is~     helpful in treating heart failure patients who are overweight. Specifically, the study will~     look at the short term effects on cardiac risk factors (blood pressure, cholesterol, blood~     sugar), heart failure symptoms, and exercise capacity.~   "
248723|NCT00297141|"~     Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the~     preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation~     of the toxicity grade III and IV of the therapy scheme~   "
248724|NCT00297128|"~     -  feasibility and tolerance of preoperative therapy with Cetuximab in combination with~          Capecitabine and radiotherapy for patients with locally advanced operable rectal~          carcinoma~        -  collection of response rate (T-downstaging, pathological complete remission),~          correlation of responsiveness with EGFR-status~   "
248725|NCT00297115|"~     The aim of the study is to compare the effect of roflumilast on exacerbation rate and~     pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast~     will be administered orally once daily in the morning at one dose level. The study duration~     will be up to 56 weeks. The study will provide further data on safety and tolerability of~     roflumilast.~      For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673~     (toll free).~   "
248726|NCT00297102|"~     The aim of the study is to investigate the effect of roflumilast on exacerbation rate and~     pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast~     will be administered orally once daily in the morning at one dose level. The study duration~     will last up to 56 weeks. The study will provide further data on safety and tolerability of~     roflumilast.~      For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673~     (toll free).~   "
248727|NCT00297089|"~     To determine the efficacy of ABT-751 when administered in combination with standard~     pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is~     complete and the study is currently enrolling subjects in Phase 2.~   "
248728|NCT00297076|"~     The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist~     GW873140 or placebo in combination with an optimized background regimen in~     treatment-experienced HIV-infected subjects with R5-tropic virus~   "
248729|NCT00297063|"~     This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone~     and placebo.~   "
248730|NCT00297050|"~     This study will evaluate the safety and tolerability of peramivir, a new drug to treat~     influenza. The study will administer gradually increasing doses of the drug in successive~     small groups of subjects to determine the optimal dose that is safe and well tolerated. It~     will be studied first at a single dose and then in multiple doses. The study will also~     determine how long peramivir stays in the body and how high the drug levels are in the blood.~      Men and women 18 - 40 years of age who weigh at least 110 lbs. and have a body mass index~     (BMI) between 19 and 32 may be eligible for this study. Candidates are screened with a~     medical history, physical examination, electrocardiogram (EKG), and blood and urine tests.~      Part I - Single Dose Escalation~      Participants are admitted to the NIH hospital for 32 to 40 hours for a single 15-minute~     intravenous infusion of peramivir or placebo (saline), followed by monitoring and evaluation.~     The drug dose is increased in successive groups of eight subjects; in each group, six~     subjects are given peramivir and two receive placebo. The first group receives 0.5 mg/kg of~     peramivir; subsequent groups receive increasingly higher doses (1, 2, 3.5, and 5 mg/kg) as~     long as the last dose was well tolerated by the preceding group. Blood samples are drawn and~     subjects are monitored for vital signs (temperature, blood pressure and heart rate) and for~     symptoms such as headache, nausea, shortness of breath or pain at 0.5, 1, 2, 3, 6, 9, 12, 18~     and 24 hours after the drug infusion. At the 24-hour evaluation they have an EKG. If needed,~     an echocardiogram (ultrasound examination of the heart) may also be done. Subjects return to~     the clinic 2, 3, 7, 14, and 28 days after the infusion for a check of vital signs, review of~     symptoms, blood draw, and urine sample collection. In addition, subjects are asked to collect~     all their urine for the first 48 hours after the study drug infusion.~      Part II - Multi-dose Escalation~      Groups of 16 subjects receive an intravenous infusion of peramivir (12 subject) or placebo (4~     subjects) once a day for 5 consecutive days. The first four infusions are given in the NIH~     outpatient clinic. The dose of peramivir is increased in successive groups of 16 subjects as~     long as the preceding dose was well tolerated. Before the infusion on day 1, subjects have a~     physical examination, blood test and EKG to obtain baseline values. After the infusion, they~     remain in the hospital for 6 hours. Vital signs and symptoms are c...~   "
248731|NCT00297037|"~     Study investigating the use of pimecrolimus 1% cream for oral lichen planus~   "
248732|NCT00297024|"~     Brain tumours often have low oxygen levels, and that makes them more resistant to radiation~     therapy. If patients breathe the right mixture of oxygen during treatment, radiation may work~     better. In this study, patients with brain tumour will undergo a special MRI test while they~     breathe different mixtures of oxygen and carbon dioxide to find out whether oxygen levels~     improve in the tumor. Patients will also be asked to repeat this MRI test during the second~     week of radiation therapy, as well as 3 months, 6 months and 1 year after RT. The MRI test~     after RT will help us understand how the blood vessels in the normal brain are affected by~     radiation.~   "
248733|NCT00297011|"~     A randomized study comparing the combination of valacyclovir and temovate gel (clobetasol~     gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).~   "
248763|NCT00296608|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     radiation therapy and chemotherapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill~     any tumor cells that remain after surgery. It is not yet known whether radiation therapy is~     more effective with or without chemotherapy when given before surgery for rectal cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy given together with~     fluorouracil and leucovorin to see how well they work compared to giving radiation therapy~     alone before surgery in treating patients with stage II or stage III rectal cancer.~   "
248996|NCT00293501|"~     RATIONALE: Tinzaparin may stop the growth of kidney cancer by blocking blood flow to the~     tumor.~      PURPOSE: This phase I/II trial is studying the side effects of tinzaparin and to see how well~     it works in treating patients with metastatic kidney cancer that cannot be removed by~     surgery.~   "
248734|NCT00296985|"~     Patients having cardiac surgery to correct their heart disease may suffer a decline in mental~     and neurologic abilities. Passage of small particles of fat, tissue waste and air bubbles to~     the brain while on the heart-lung machine is thought to be one cause for decline in mental~     and neurologic abilities (the function of brain) after surgery.~      The purpose of this study is to determine if replacement of cardiotomy suction (one part of~     the heart-lung machine) with the cell-saver (a different part of the heart-lung machine)~     during surgery will help to prevent a decline in mental and neurologic abilities after~     surgery. investigating 312 patients over 2 years,patients will be assigned randomly to either~     cardiotomy suction or cell-saver group. Patients will be given questionnaires before surgery,~     6 weeks and 1-year after surgery. These questionnaires will assess memory, attention span,~     the ability to concentrate and the quality of life. Patients will also have a brief~     neurologic exam (physical examination to check mental state, reflexes, strength, and balance)~     before surgery, 3-5 days after surgery, 6 weeks and 1-year after surgery to determine any~     changes. Cell-saver separates red blood cells from tissue waste products and fat prior to~     returning blood back to the patient and may reduce the negative effects of particles of fat,~     tissue waste and air bubbles have on the brain. Potential benefits of cell-saver device when~     used during surgery may prevent the decrease in memory, attention span, and the ability to~     concentrate resulting in improved quality of life after surgery.~      Objectives: The primary aim is to determine the effect of continuous flow cell-saver on short~     and long term neurocognitive function after cardiac surgery, measured by precise preoperative~     and postoperative psychometric and neurologic testing. Hypothesis: The primary hypothesis:~     Continuous flow cell-saver reduces postoperative neurocognitive decline following cardiac~     surgery. Methodology: 312 informed and consenting patients, age > 65 years, scheduled for~     coronary artery bypass graft surgery will be prospectively enrolled over a 2-year period.~     Patients will be randomly allocated to either the continuous flow cell-saver or conventional~     cardiotomy suction (controls). Neurological history and physical exam will be completed~     preoperatively, discharge, 6-weeks and 1-year after surgery. Transcranial Doppler scanning~     will be used for intraoperative monitoring of cerebral embolic load. Transesophageal~     echocardiography and epiaortic scanning will be employed to account for the severity of the~     aortic atheroma scores. Neurocognitive testing and quality of life assessment will be~     conducted preoperatively , 6-weeks and 1-year after surgery. Significance: The utilization of~     continuous flow cell-saver may reduce the negative effects of fat particles, tissue waste and~     air emboli have on brain.~   "
248735|NCT00296972|"~     The main purpose of this study is to compare the safety, effectiveness and tolerability of~     using Pegasys with Copegus in people who have both the hepatitis C virus (HCV) genotype 1 and~     HIV who continue taking HAART (highly active antiretroviral therapy) to those who discontinue~     taking HAART.~      Canadian guidelines recommend that both HIV and HCV should not be treated at the same time as~     the medications needed to treat these two diseases may interact and that which disease to~     treat first is dependent on the CD4 count. In this study, the CD4 count must be over 350~     cells and one must be stable on HAART before starting the study medication Pegasys in~     combination with Copegus.~   "
248736|NCT00296959|"~     A phase II double blind trial to evaluate the effects of the AMPA, glutamte antagonist,~     topiramate on levodopa-induced dyskinesia in Parkinson's disease~   "
248737|NCT00296946|"~     A phase II double blind clinical trial investigating the effects of ipratropium spray versus~     placebo spray in patients with Parkinson's disease.~   "
248738|NCT00296933|"~     Major Depressive Disorder (MDD) is a serious illness associated with considerable morbidity,~     risk of suicide and adverse social consequences (Montgomery et al., 1994a). Cognitive~     impairment is one of the three major symptom areas of MDD. Specifically, memory impairment~     and concerns are one of the most commonly reported complaints in MDD. While antidepressant~     (AD) treatments vary a great deal in their propensity to cause cognitive impairment, there~     remains a paucity of empirical evidence on the effects of AD treatment on neuropsychological~     indices of memory functioning in non-geriatric depressed individuals. Hence, comparative~     effects of various AD drugs on memory functioning remain unclear.The aim of this study is to~     evaluate multiple aspects of memory functioning (short-term, working memory, verbal,~     non-verbal, spatial and prospective memory) of MDD patients before and after 8 weeks of~     antidepressant treatment with bupropion XL or escitalopram.~   "
248739|NCT00296920|"~     Despite many available treatments, there are patients with major depression who remain~     treatment refractory and chronically disabled. For these severely ill patients, several~     neurosurgical procedures are available where brain lesions are made that interrupt white~     matter tracts linking orbital frontal cortex to the striatum, resulting in significant~     therapeutic benefit for many patients. In this study, we will test the safety and efficacy of~     Deep Brain Stimulation (DBS)--a reversible method used to modulate brain activity--as an~     alternative to the standard subcaudate tractotomy (SCT). The physiological consequences of~     this procedure will be mapped longitudinally using positron emission tomography (PET)~     measures of brain glucose metabolism. Patients will be clinically monitored for 1 year with~     longitudinal psychiatric, neurological, neurosurgical, neuropsychological and PET imaging~     examinations to assess treatment efficacy and side effects.~   "
248740|NCT00296907|"~     The purpose of the study is to evaluate the effectiveness of a two-session brief~     psychological intervention in siblings of pediatric cancer patients with regard to behavior~     problems and depression.~   "
248741|NCT00296894|"~     Patients will be randomized into two groups (1/1) during one year:~        -  40 mg adalimumab subcutaneously (sc) every other week~        -  placebo~      The effect on x-rays and clinical parameters will be evaluated.~   "
248742|NCT00296881|"~     This study is to determine whether scaling and root planning (SRP) followed by photodynamic~     disinfection results in improved outcomes that persist over time in adults with chronic~     periodontitis when compared with subjects with SRP alone.~   "
248743|NCT00296868|"~     Complex Regional Pain Syndrome or posttraumatic dystrophy is a pain syndrome which develops~     after a trauma, surgery or for unknown reason. The incidence after wrist fractures varies in~     literature from 2 - 37%. The female sex is involved three times as much as the male sex.~     There is one study in literature which describes a prophylactic effect of vitamin C after~     wrist fractures. Goal of this study is to search for a dose dependent effect of vitamin C and~     to replicate these earlier findings.~   "
248744|NCT00296855|"~     The particular aim of this study is the comparison of the diagnostic results of MRA images~     upon application of Vasovist (gadofosveset), a contrast agent not yet available on the~     market, with the MRA images upon application of a conventional extracellular contrast agent.~     A catheter angiography, which will be performed as a routine diagnostic procedure for~     vascular diseases, will serve as an evaluation standard.~   "
248745|NCT00296842|"~     The purpose of this study is to study the effectiveness of an early psychological~     intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of~     children and adolescents~   "
248780|NCT00296387|"~     The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in~     treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following~     the onset of the first symptoms is beneficial compared to placebo.~   "
248781|NCT00296374|"~     The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor)~     atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes~     with moderate proteinuria and hypercholesterolaemia.~   "
248746|NCT00296829|"~     All marketed influenza vaccines are injected by the intramuscular route. This study will test~     whether an influenza vaccine is effective when injected by other route than into the muscle.~     In order to prove this, the amount of antibodies in the blood will be measured before and~     after vaccination. In addition, the safety of both influenza vaccines will be tested by~     evaluating all serious reactions occurring after vaccination. The vaccine injected in this~     study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip).~      Primary Objective:~      To demonstrate and compare the immune response of two dosages of influenza vaccine~     administered by an alternate route to the intramuscular administration of the vaccine.~      Secondary Objectives:~        -  To compare the immune response 21 days after vaccination between each investigational~          group versus intramuscular group for each influenza strain.~        -  To describe the safety profile after the vaccination in each study group~        -  To describe the compliance of the two dosages of the vaccine administered by the~          alternate route with the European Medicine Agency.~      Observational Objectives:~        -  To describe the safety profile during the 21-day period following an intramuscular~          revaccination in each group and the possibility of any reaction at the first injection~          site.~        -  To describe the pain at the injection site with a Visual Analog Scale and the~          acceptability of the injection using a questionnaire in each group.~        -  To describe the leakage appearing at the injection site immediately after the alternate~          route injection and to explore the relationship with immunogenicity.~        -  To evaluate the cellular mediated immune response in a subset of subjects.~   "
248747|NCT00296816|"~     Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and~     oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of~     angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent~     addition of bevacizumab (Avastin®).~   "
248748|NCT00296803|"~     The purpose of this study is to examine the effects of clopidogrel compared to placebo on~     markers of inflammation in subjects with metabolic syndrome who are receiving background~     therapy including low dose aspirin.~   "
248749|NCT00296790|"~     A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of~     Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with~     Escitalopram (Lexapro - antidepressant).~   "
248750|NCT00296777|"~     The main purpose of this study is to correlate brain testing with treatment outcome.~   "
248751|NCT00296764|"~     Angelman Syndrome (AS) is a developmental disorder that is caused by a deficiency of a~     maternally transmitted gene. It is inherited at birth, and affects movement, speech, and~     social demeanor. This study will gain a better understanding of the disease progression and~     clinical features of AS by observing children with AS over an extended period of time.~   "
248752|NCT00296751|"~     60 female that care for pain control during second stage of delivery, will choose between~     epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the~     second stage for 10 minutes. 30 minutes after administration of either pain relief, a second~     recording of maternal ECG will take place for 10 minutes.~   "
248753|NCT00296738|"~     Myocardial scintigraphy with 123I-MIBG allows for visual and semi-quantitative assessment of~     sympathetic cardiac innervation using the hear to mediastinum ratio (HMR). Impaired cardiac~     MIBG clearance may occur in patients with congestive heart failure (CHF). The purpose of~     present study was to develop and validate a quantitative index for the assessment of cardiac~     MIBG uptake kinetics using SPECT/CT for diagnosis of CHF~   "
248754|NCT00296725|"~     Depressed patients will have hearing tests and then be treated with up to three treatments~     (i.e., Fluoxetine, Imipramine and Placebo) until remitted, to see whether test results~     predict specific outcomes.~   "
248755|NCT00296712|"~     Relatively drug naive patients will receive two antidepressant medications as initial~     treatment.~   "
248756|NCT00296699|"~     This is a Pilot Study to get a first indication whether Duloxetine may be effective for~     depressed patients with Atypical Features.~   "
248757|NCT00296686|"~     This pilot study will assess the efficacy of several sequential pharmacological treatments~     for patients with Refractory Depression.~   "
248758|NCT00296673|"~     The purpose of this study is to determine the effects of reactive neuromuscular training on~     muscular endurance test.~   "
248759|NCT00296660|"~     The purpose of this study is to collect data and body fluid samples from people with acute or~     established HIV infection and from HIV uninfected people. Data from this study will be used~     to better understand properties of HIV, including HIV transmission and the differences~     between acute and established HIV infections.~   "
248760|NCT00296647|"~     The information gathered in this study may help to develop more effective ways to help people~     quit smoking and stay quit in the future.~   "
248761|NCT00296634|"~     This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy~     adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and~     dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine~     when given alone or combined with aluminum hydroxide. A secondary goal is to guide selection~     of vaccine dosage levels for expanded Phase II trials based on reactogenicity and~     immunogenicity profiles. This dose optimization will be applied to both younger and older~     subject populations in subsequent studies. Subjects who meet the entry criteria for the study~     will be enrolled at one of 4 study sites and will be randomized into one of 8 groups to~     receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of HA with or~     without aluminum hydroxide adjuvant by intramuscular injection. Participants may be involved~     in study related procedures for up to 8 months.~   "
248762|NCT00296621|"~     The purpose of this study is to determine whether long-term oral glutamine supplementation is~     effective in improving muscle mass and function in children with Duchenne muscular dystrophy~     (DMD).~   "
248782|NCT00296361|"~     Primary objective of this study is to compare the two therapy regimens with regard to renal~     function by using calculated creatinine clearance. The secondary objectives are to compare~     the efficacy and safety profiles of the two therapy regimens.~   "
248997|NCT00293488|"~     RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in~     treating patients with relapsed or refractory lymphoma.~   "
248764|NCT00296595|"~     Diet has long been used as a way to provide enough nutrients to an individual in order to~     meet metabolic requirements. However, recent scientific advancements have suggested that~     beyond meeting nutrition needs, diet may also be health promoting through the modulation of~     various body functions. In a way, the role of nutrition has evolved from hunger satisfaction~     and maintenance of body integrity to the promotion of a state of well-being and prevention of~     important chronic diseases such as cancer, diabetes and cardiovascular disease (CVD). In~     recent years, n-3 polyunsaturated fatty acids (PUFA) have attracted much attention as~     consumption of a n-3 PUFA rich diet has been reported to reduce CVD risk. However, n-3 PUFA~     are also highly susceptible to free radical damage and therefore could be unable to fully~     exert their health benefits under an oxidative stress condition. The general objective of the~     present application is to investigate the mechanisms by which n-3 PUFA improve cardiovascular~     health in abdominal obesity and explore the potential of dietary antioxidants to modulate~     these effects in individuals at high risk of oxidative stress. For that purpose, we plan to~     study the changes in fasting and postprandial plasma lipoprotein-lipid levels, markers of~     lipid and lipoprotein oxidation, inflammation and endothelial dysfunction following 12 weeks~     of n-3 PUFA supplementation with or without low-calorie cranberry juice cocktail (as a source~     of antioxidants) in a group of 160 men. We feel that the present study will broaden our~     understanding of the physiological mechanisms underlying the beneficial effects of consuming~     unsaturated fatty acids and give further insights on the role of antioxidants in preserving~     and potentiating these cardiovascular health benefits.~   "
248765|NCT00296582|"~     This study is being done to measure the functions of the stomach after eating a meal and to~     develop a new method that will simultaneously measure both gastric emptying and the~     relaxation of the stomach after a meal using nuclear medicine testing. This would make the~     testing more convenient for patients and will also offer better understanding of these two~     gastric functions.~   "
248766|NCT00296569|"~     This study is being conducted to assess the safety and tolerability of MK-0686 and to~     evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.~   "
248767|NCT00296556|"~     The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the~     treatment of mild to moderate ulcerative colitis.~   "
248768|NCT00296543|"~     The purpose of this study is to determine if the hemodialysis procedure changes the risk for~     cardiac arrest in patients.~   "
248769|NCT00296530|"~     This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain~     clinic visits will include a physical examination, medical history review, and lung function~     tests. All study related medications and medical examinations will be provided at no cost to~     the subject. The drugs used in this study are approved for the age group under study.~   "
248770|NCT00296517|"~     This study is designed to evaluate the efficacy and safety in depressive patients who did not~     respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).~   "
248771|NCT00296504|"~     GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble~     and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV~     versus sixteen 150mg capsules daily for APV. This study is designed to provide additional~     information on long term safety and tolerability of FPV containing regimens for those~     subjects who received FPV in previous GlaxoSmithKline studies.~   "
248772|NCT00296491|"~     This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain~     clinic visits will include a physical examination, medical history review, and lung function~     tests. All study related medications and medical examinations will be provided at no cost to~     the subject. The drugs used in this study are approved for the age group under study.~   "
248773|NCT00296478|"~     This multicenter, randomized, open-label study will be performed in approximately 990 healthy~     females undergoing IVF. Each study center will follow their study center standard practice~     for IVF unless otherwise noted in this protocol. The study centers will be provided with the~     medications for down regulation, stimulation and ovulation induction. The subjects will be~     randomized to study medication on the day of oocyte retrieval or the day following and will~     continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be~     required to return to the clinic several times during the course of the 10 week treatment~     period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.~   "
248774|NCT00296465|"~     This study will be performed in approximately 132 women with anovulatory/oligoovulatory~     infertility.~   "
248775|NCT00296452|"~     To determine if using a nutritionally enhanced supplement will improve mucositis in head and~     neck cancer patients~   "
248776|NCT00296439|"~     Hemodialysis patients who receive frequent weekly nutrition counseling using motivational~     interviewing techniques will have lower serum phosphorus levels compared to patients~     receiving standard treatment.~   "
248777|NCT00296426|"~     An incomplete understanding of patients' preadmission medications and failure to reconcile~     these with medications ordered in the hospital and at discharge are major, previously~     unappreciated, causes of adverse drug events (ADEs). The Joint Commission for Accreditation~     of Healthcare Organizations has now mandated a process for reconciling all medications at~     hospital admission and discharge. The best ways to implement medication reconciliation and~     the impact on patient outcomes are unknown. We, the researchers at at Brigham and Women's~     Hospital, will design and implement a medication reconciliation process with two major~     components: 1) information technology to integrate medication reconciliation into the current~     workflow at Brigham and Women's Hospital (BWH); and 2) process re-design involving~     physicians, nurses, and pharmacists to ensure that reconciliation takes place. We will then~     conduct a randomized controlled trial on the General Medical Service of BWH to evaluate the~     effects of this new process on reducing medication reconciliation errors with the potential~     to cause patient harm (potential ADEs).~   "
248778|NCT00296413|"~     Some antiseizure medication levels are affected by hormones. This study is being done to~     determine if blood levels of lamotrigine or valproate are affected by the hormones in the~     birth control pill or the menstrual cycle itself.~   "
248779|NCT00296400|"~     The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor)~     atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate~     proteinuria and hypercholesterolaemia.~   "
248783|NCT00296348|"~     The primary objective of this study is to investigate the impact of early corticosteroid~     withdrawal in paediatric renal transplant patients on growth expressed as change in height~     standard deviation score (SDS) from baseline to end of study as the primary endpoint. The~     expected advantages are reduced growth suppression, lower incidence of arterial hypertension~     and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by~     lower serum lipid values.~   "
248784|NCT00296335|"~     This is a phase III randomized study designed to evaluate the efficacy of mitomycin,~     doxifluridine, and cisplatin compared to mitomycin and doxifluridine.~   "
248785|NCT00296322|"~     This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with~     early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine~     compared to mitomycin plus doxifluridine in resected advanced gastric cancer.~   "
248786|NCT00296309|"~     Primary objective of this study is to compare the renal function as well as the incidence of~     renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary~     Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal~     transplanted patients.~   "
248787|NCT00296296|"~     Protocol Title: Randomized open label study comparing the metabolic control of first Kidney~     Transplant recipients with Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral~     as part of a ATG induction, prednisone free and blood monitored Cellcept immunosuppressive~     regimen.~      PURPOSE This is a single center medical research study to analyze post-transplant kidney~     recipients with pre-existing type 2 diabetes managed according to the recommended American~     Diabetes Association (ADA) guidelines. Prograf (Tac) and Neoral (CSA) are the two main~     medications to prevent rejection after transplantation. However, they may contribute to~     poorer diabetes control. The purpose of the study is to compare the effects of Prograf and~     Neoral on the control of Diabetes after kidney transplantation. In addition, all participants~     in this study will receive Thymoglobulin (anti-lymphocyte globulin) at the time of~     transplantation instead of long term prednisone (steroids).~   "
248788|NCT00296283|"~     This pilot study is looking at the effects of a brief psychoeducational workshop. These one~     day workshops are designed to increase family members knowledge about bipolar disorder and to~     help with processing emotions that go along with having a relative with bipolar disorder.~   "
248789|NCT00296270|"~     Objectives: To determine whether people systematically misremember the “myths” (false~     information) as true, and to assess effects on perceptions of risk and behavioral intentions.~   "
248790|NCT00296257|"~     To compare the efficacy of SMP-114 (120 and 240 mg/d) versus placebo in terms of the~     percentage of patients meeting the American College of Rheumatology criteria for 20%~     improvement in RA (ACR20) at week 24. The study hypothesis would be to demonstrate that the~     use of methotrexate and SMP-114 is more efficacious than Methotrexate alone.~   "
248791|NCT00296244|"~     The purpose of this study is to determine whether steroid-related complications can be~     avoided by using steroid-free immuno-suppressive drug regimen after liver transplantation.~   "
248792|NCT00296231|"~     The purpose of this study is to test whether application of high frequency ventilation~     through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.~   "
248793|NCT00296218|"~     Primary Objective~        -  The main objective of this study is to assess if a two-month regimen of irbesartan in~          patients hospitalized for acute coronary syndrome without ST segment elevation can~          reduce inflammation markers (ie hsCRP), in comparison to a similar regimen of enalapril.~      Secondary Objectives~        -  To compare both regimens on several other biological parameters which have demonstrated~          their relevance and their predictive clinical value (ie BNP, microalbuminuria, troponin~          I …) in this patient population.~        -  To compare on the above parameters the early initiation of treatment versus the~          initiation of treatment at hospital discharge.~   "
248794|NCT00296205|"~     The purpose of this study is to determine what percentage of patients receiving high-dose~     Cyclophosphamide may experience a halt in the worsening of their disease or experience~     improvement of their disease and for how long the benefit may last.~   "
248795|NCT00296192|"~     The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM~     952) in a single dose application scheme.~      Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be~     checked. Subjects will then be hospitalized for one night. In the morning of the next day,~     subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then~     receive a single dose of trial medication. Safety assessments after application include~     adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and~     laboratory checks. Efficacy will be assessed by application of motor examination scores.~      The first subject is planned to be enrolled in February 2006. The last subject is planned to~     be enrolled in May 2006. Last subject out is expected for August 2006.~   "
248796|NCT00296179|"~     To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate~     extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and~     escitalopram at 2 months.~   "
248797|NCT00296166|"~     Patents with atrial fibrillation can be treated with the purpose of curing the~     arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter~     includes open heart surgery.~      By catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes~     of atrial fibrillation. In patients with permanent atrial fibrillation the results are not as~     good.~      We will compare a conventional ablation approach where lesions are created on the inside of~     the heart with a thoracoscopic approach where the lesions are created from the outside of the~     heart.~   "
248798|NCT00296153|"~     The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid~     parameters and on the function and stiffness of blood vessels in HIV infected patients on~     Antiretroviral Therapy (HAART)~   "
248799|NCT00296140|"~     Post Stroke Depression(PSD)is a high volume condition with negative impact on patient~     recovery after stroke. The primary aim of this study is to evaluate the effectiveness of a~     system intervention to improve the proportion of Veterans screened and started on treatment~     for PSD.~      The secondary aim is evaluate whether a patient-based self-management intervention provides~     any additional benefit compared to usual care.~   "
248800|NCT00296127|"~     To evaluate the bioavailability of celecoxib administered as capsule contents sprinkled onto~     applesauce relative to intact capsule~   "
248801|NCT00296114|"~     To prospectively collect serum and DNA samples from subjects with pancreatic cancer,~     pancreatitis, liver disease, and from healthy and at-risk volunteers in order to identify~     novel biomarkers for early diagnosis, differential diagnosis, stage, natural history of the~     disease, response to treatment, and to identify novel targets for therapeutic interventions.~     In particular:~   "
248802|NCT00296101|"~     Physical inactivity is a major public health problem in the United States. Research has shown~     that physical activity levels decline during adolescence, and the decline is greater in~     females than males. The purpose of this study is to evaluate a life-skills oriented physical~     activity intervention at increasing activity levels and decreasing cardiovascular risk~     factors in adolescent females.~   "
248803|NCT00296088|"~     Obesity is a significant health care issue in the United States, particularly among the~     critically ill. Preliminary research has shown that differences in ventilator management~     exist among obese and non-obese individuals. This study will examine the effect of excess~     weight on ventilator management and clinical outcomes in individuals in an intensive care~     unit (ICU).~   "
248804|NCT00296062|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some find tumor cells and kill them or carry tumor-killing substances to~     them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may~     also block blood flow to the tumor. Giving combination chemotherapy together with bevacizumab~     may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine~     when given together with irinotecan and oxaliplatin with or without bevacizumab and to see~     how well they work in treating patients with metastatic or locally advanced colorectal cancer~     or other solid tumors that cannot be removed by surgery.~   "
248805|NCT00296049|"~     RATIONALE: Antibiotics, such as daptomycin and vancomycin, may be effective in treating~     bacteria in the blood. It is not yet known whether daptomycin is more effective than~     vancomycin in treating bacteria in the blood in patients with neutropenia caused by~     chemotherapy.~      PURPOSE: This randomized clinical trial is studying daptomycin to see how well it works~     compared with vancomycin in treating bacteria in the blood in patients with neutropenia~     caused by chemotherapy.~   "
248806|NCT00296036|"~     RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or~     lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving~     pyridoxine with or without topical urea/lactic acid-based cream is more effective than~     topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome.~      PURPOSE: This randomized phase III trial is studying pyridoxine and topical urea/lactic~     acid-based cream to see how well they work compared with giving pyridoxine together with a~     placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two~     placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for~     breast cancer or other cancer.~   "
248807|NCT00296023|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor~     bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells.~     It also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune system and help destroy any remaining cancer~     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor~     lymphocyte infusion) after the transplant may help increase this effect. Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving antithymocyte globulin before transplant and methotrexate and tacrolimus after~     the transplant may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in~     treating older or frail patients with hematologic cancer.~   "
248808|NCT00296010|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal~     doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor~     cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin~     after surgery is more effective than observation or cyclophosphamide and methotrexate in~     treating breast cancer.~      PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it~     works compared with observation or cyclophosphamide and methotrexate in treating older women~     who have undergone surgery for breast cancer.~   "
248809|NCT00295997|"~     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem~     cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It~     also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune system and help destroy any remaining cancer~     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor~     lymphocyte infusion) after the transplant may help increase this effect. Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate~     mofetil after transplant may stop this from happening.~      PURPOSE: This clinical trial is studying how well a donor stem cell transplant works in~     treating patients with hematologic cancer, metastatic kidney cancer, or aplastic anemia.~   "
248810|NCT00295984|"~     RATIONALE: Nicotine may stimulate the immune system to kill Kaposi's sarcoma cells.~      PURPOSE: This phase II trial is studying the side effects and how well the nicotine skin~     patch works in treating patients with Kaposi's sarcoma.~   "
248823|NCT00295815|"~     This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of~     recurrent brain cancer (specifically intracranial glioblastoma multiforme).~   "
248824|NCT00295802|"~     The purpose of this study is to determine the substantial equivalence of the Ablatherm high~     intensity focused ultrasound (HIFU) as compared to cryotherapy for the treatment of low risk,~     localized prostate cancer.~   "
248825|NCT00295789|"~     To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel~     plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer~   "
248826|NCT00295776|"~     To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in~     patients with post herpetic neuralgia.~   "
248811|NCT00295971|"~     RATIONALE: Giving chemotherapy and total body irradiation before a donor bone marrow~     transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It~     also helps stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving antithymocyte globulin and removing the T cells from the donor cells before transplant~     may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects and best dose of donor T cells and~     antithymocyte globulin when given together with chemotherapy and total-body irradiation in~     treating young patients who are undergoing T-cell depleted donor stem cell transplant for~     myelodysplastic syndrome, leukemia, bone marrow failure syndrome, or severe immunodeficiency~     disease.~   "
248812|NCT00295958|"~     RATIONALE: The LMB-2 immunotoxin can find tumor cells and kill them without harming normal~     cells. Vaccines made from peptides may help the body build an effective immune response to~     kill tumor cells. Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving LMB-2 immunotoxin together with~     vaccine therapy works in treating patients with metastatic melanoma that cannot be removed by~     surgery.~   "
248813|NCT00295945|"~     RATIONALE: Giving pain medication into the space between the wall of the spinal canal and the~     covering of the spinal cord or giving it into a vein may help lessen pain caused by cancer~     surgery. It is not yet known whether epidural analgesia is more effective than~     patient-controlled analgesia in controlling pain in patients who have undergone surgery for~     gynecologic cancer.~      PURPOSE: This randomized clinical trial is studying epidural analgesia to see how well it~     works compared to patient-controlled analgesia in treating patients who have undergone~     surgery for gynecologic cancer.~   "
248814|NCT00295932|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and prednisone,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer~     growth in different ways. Some block the ability of cancer cells to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them. Giving~     bortezomib together with cyclophosphamide, prednisone, and rituximab may be an effective~     treatment for non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     bortezomib when given together with cyclophosphamide, prednisone, and rituximab and to see~     how well it works in treating patients with relapsed or refractory indolent B-cell~     non-Hodgkin's lymphoma.~   "
248815|NCT00295919|"~     RATIONALE: Drugs used in chemotherapy, such as fenretinide LXS, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide LXS in~     treating patients with recurrent, refractory, or persistent neuroblastoma.~   "
248816|NCT00295906|"~     RATIONALE: Computer-based continuing education courses may be effective in improving the~     skills of primary care doctors to identify skin cancer risk factors, perform skin cancer~     exams, and counsel patients. They may also improve the skills of primary care doctors to~     assess and counsel patients on their weight, diet, and physical activity.~      PURPOSE: This randomized clinical trial is studying how well computer-based continuing~     education courses work in improving doctors' ability to perform skin cancer or weight control~     exams and counseling during routine office visits.~   "
248817|NCT00295893|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as~     trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving combination chemotherapy with or without trastuzumab before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. It is not yet known whether combination chemotherapy is more effective with or~     without trastuzumab in treating breast cancer.~      PURPOSE: This randomized phase II trial is comparing two different regimens of combination~     chemotherapy given together with or without trastuzumab to see how well they work in treating~     patients with stage II or stage III breast cancer.~   "
248818|NCT00295880|"~     Rationale: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood~     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from the~     donor's umbilical cord blood are injected into the patient's bone marrow they may help make~     stem cells, red blood cells, white blood cells, and platelets.~      Purpose: This phase I/II trial is studying the side effects of donor umbilical cord blood~     transplant when given directly into the bone marrow and to see how well it works in treating~     patients with hematologic cancer.~   "
248819|NCT00295867|"~     RATIONALE: Zoledronate may delay or prevent bone marrow metastases in patients with breast~     cancer.~      PURPOSE: This phase II trial is studying how well zoledronate works in treating bone marrow~     micrometastases in women with stage I, stage II, or stage III breast cancer.~   "
248820|NCT00295854|"~     To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg~     once daily vs. placebo in patients with Interstitial Cystitis.~   "
248821|NCT00295841|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when~     given together with cytarabine and to see how well they work in treating patients with~     refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.~   "
248822|NCT00295828|"~     The purpose of this study is to determine if a drug called Macugen may help to stop the~     growth of abnormal blood vessels on the iris that has occurred in the eye(s) as part of~     diabetic retinopathy.~   "
248827|NCT00295763|"~     Patients diagnosed with thyroid cancer are commonly treated with surgery to remove their~     thyroid gland followed by radioiodine ablation to destroy any remaining parts of the thyroid~     gland that may have been missed during surgery. It is thought that ablation with radioiodine~     destroys normal remaining thyroid tissue as well as cancerous cells either in the thyroid~     area or at other sites.~      Following successful treatment, patients are then monitored by their physicians at regular~     intervals with testing to detect any recurrence of thyroid cancer throughout the body. If~     thyroid cells are detected by these follow up tests, the physician will decide the best~     method to re-treat the patient.~      In 2001-2003 Genzyme conducted a clinical study to test if Thyrogen® can be used to~     accomplish radioiodine ablation treatment. This study aimed to determine that the success~     rates of radioiodine ablation were comparable when patients were prepared for ablation with~     Thyrogen® while being maintained on their normal thyroid hormone therapy, or, alternatively,~     by thyroid hormone withdrawal. Thyroid hormone withdrawal commonly causes uncomfortable side~     effects for patients, and these might be avoided by the use of Thyrogen.~      Eight months after the initial Thyrogen plus radioiodine treatment to achieve ablation, all~     patients in both groups were given Thyrogen® to test for any remaining thyroid tissue. The~     results of this testing showed that all patients (in both groups) had successfully achieved~     remnant ablation and had no detectable thyroid tissue remaining.~      In order to confirm these remnant ablation results we will conduct follow up testing in this~     study for all patients that were enrolled in the previous study and we also will determine if~     their thyroid cancer has recurred. Only patients who completed this previous Thyrogen~     ablation study are eligible for entry into this study.~   "
248828|NCT00295750|"~     The study was a three-arm, active-control, multi-centre, parallel group study.~   "
248829|NCT00295737|"~     The primary objective of this study is to isolate macrophages by using bronchoalveolar lavage~     (BAL) for different in vitro experiments.~      Therefore, following a baseline BAL, allergen, endotoxin, and saline will be instilled into~     three different lung segments during the first bronchoscopy. After 24 hours during a second~     bronchoscopy, BAL fluid will be collected in these challenged segments to harvest invaded~     cells for in vitro experimentation. In addition, segmental bronchial biopsies will be taken~     to assess the degree of local inflammation.~   "
248830|NCT00295724|"~     -  The primary objectives of this placebo-controlled clinical trial are to evaluate the~          analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients~          with moderate to severe chronic low back pain.~        -  The secondary objectives are to evaluate the effect of bicifadine on function and~          general quality of life, to evaluate safety following discontinuation of bicifadine~          treatment and to investigate the population pharmacokinetics of bicifadine.~   "
248831|NCT00295711|"~     The primary objectives of this placebo-controlled clinical trial are to evaluate the~     analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo~     in patients with moderate to severe chronic low back pain.~      The secondary objectives are to investigate the dose-response relationship of three dose~     levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to~     evaluate the effect of bicifadine on function and general quality of life, to describe the~     population pharmacokinetics of bicifadine in patients with chronic low back pain, and to~     evaluate safety following discontinuation of bicifadine treatment.~   "
248832|NCT00295698|"~     The impact of lymphatic filariasis (LF) on HIV is assessed by measuring HIV viral load before~     and after DEC treatment of filariasis in double-infected individuals. The impact of HIV on~     lymphatic filariasis is assessed by measuring the success of DEC treatment on W. bancrofti~     antigenaemia and microfilaraemia in double-infected individuals. The effect of DEC treatment~     in individuals with lymphatic filariasis and/or HIV is assessed by measuring the pre- and~     post-treatment level of HIV viral load, immunological responses and micronutritional~     parameters, including antioxidants and markers of oxidative stress, in single- or~     double-infected individuals. The study is carried out as an anonymous, unlinked and~     double-blind placebo controlled study with cross-over design. The study groups comprise: 1)~     18 double-infected individuals (HIV+/LF+), 2) 16 HIV infected individuals (HIV+/LF-) and 3)~     25 individuals with lymphatic filariasis (HIV-/LF+). Based on stratified, blocked~     randomisation the study participants receive DEC treatment or placebo. Pre- and~     post-treatment (1 week, 12 weeks and 24 weeks post-treatment) blood samples are collected and~     analysed for HIV viral load, CD4+ T cell count, distinctive Th1 and Th2 cytokines,~     circulating filarial antigens (CFA), micronutrient status, antioxidant enzymes and markers of~     oxidative stress. After 12 weeks the study participants get the opposite treatment and~     post-treatment blood samples are collected four times with the same intervals as above.~   "
248833|NCT00295685|"~     The purpose of this study is to determine if people taking lansoprazole two times a day to~     control severe GERD symptoms can be controlled just as well, if not better, by taking Nexium~     just once a day.~   "
248834|NCT00295672|"~     Our aim is to conducted a multicenter phase II trial of the cisplatin-oral vinorelbine~     -radiotherapy combination after induction chemotherapy with cisplatin-docetaxel in patient~     with NSCLC. Oral vinorelbine will be used in the present study rather than the intravenous~     form because: 1- Previous investigations have demonstrated that oral vinorelbine is as~     effective as the intravenous form in the treatment of NSCLC. 2 - We think that the use of~     oral agents in CT will reduce some disagreements provoked by intravenous injections: stress,~     infections, hemorrhage, displacement at the hospital and cost of CT.~   "
248835|NCT00295659|"~     Diabetes in pregnancy or gestational diabetes (GDM) is a condition that, if left untreated,~     may lead to complications for the mother and her baby. It is still not known which is the~     best method to diagnosis GDM. The goal of this study is to compare three well-accepted~     methods for diagnosis of GDM (using either 75 g or 100 g in the glucose tolerance test) and~     determine which method is the easiest and least expensive to use in relation to the reference~     method used over the last 20 years. The goal is to see if they can equally predict the~     healthy outcome of the pregnant mother and her newborn.~   "
248836|NCT00295646|"~     The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the~     comparison of zoledronate added to standard adjuvant therapy with controls according to~     disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer~     treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard~     adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal~     blockade combined with an antiestrogen or aromatase inhibitor.~   "
248837|NCT00295633|"~     The purpose of this clinical research study is to learn whether Saxagliptin added to~     thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2~     diabetic subjects who are not sufficiently controlled with TZD alone~   "
248838|NCT00295620|"~     The study assesses the effect of further 2 years vs further 5 years of adjuvant treatment~     with anastrozole after initial 5 years of adjuvant endocrine therapy.~   "
248839|NCT00295607|"~     This is an exploratory study to evaluate the impact of eliminating steroid administration~     upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in~     patients transplanted for HCV cirrhosis.~   "
248841|NCT00295581|"~     This study, conducted at Johns Hopkins University Center for Immunization Research in~     Washington DC, will test the safety and immune response of healthy volunteers to two~     experimental malaria vaccines. Malaria is a disease of red blood cells caused by a parasite~     that spreads from person to person by mosquitoes. It affects people of all ages, but is~     particularly severe in children. Patients may have a high fever, chills and muscle aches.~     They sometimes can have severe complications that may even result in death.~      The vaccines in this study are called transmission blocking vaccines. These vaccines~     stimulate the person's immune system to produce antibodies against malaria. When a mosquito~     bites a vaccinated person, it ingests some of the person's blood. The antibodies in the~     ingested blood stop the malaria parasite from developing inside the mosquito. The mosquito~     would not be able to transmit malaria to other people. PpPfs25/ISA51 (Vaccine A) stimulates~     production of antibodies against the malaria parasite Plasmodium falciparum, and~     ScPvs25/ISA51 (Vaccine B) stimulates antibodies against the malaria parasite Plasmodium~     vivax. The vaccines also contain a substance called Montanide ISA51, which boosts the immune~     response to the vaccine.~      Healthy volunteers between 18 and 50 years of age may be eligible for this study. Candidates~     are screened with a medical history, physical examination, and blood and urine tests. Women~     who are able to become pregnant have a urine pregnancy test before each immunization.~      Participants are randomly assigned to receive two injections, spaced 4 months apart, of~     either Vaccine A or Vaccine B at one of three doses-high, medium, or low. Two subjects in~     each dose group additionally serve as controls and receive only Montanide ISA51 mixed with~     saline. The vaccine is injected into the muscle of the upper arm. Subjects are monitored for~     30 minutes after each injection for possible side effects and take home a diary card to~     record their temperature and any symptoms that may appear over the next 13 days.~      A blood sample is drawn before and on several occasions after each vaccination to check the~     subject's health and to evaluate the immune response to the vaccine. At 1, 3, 7, 14, and 21~     days after each vaccination, participants come to the clinic for a check of vital signs~     (temperature, pulse, respiration, and blood pressure), brief physical examination, and~     history of symptoms since the previous visit.~   "
248842|NCT00295568|"~     This study will examine how the two sides of the brain interact when learning precision hand~     movements. Both sides of the brain are active when a person performs an accurate hand~     movement. This study will look at the extent to which the two brain hemispheres interact when~     learning accurate hand movements.~      Healthy, right-handed normal volunteers 18 - 40 years of age may be eligible for this study.~     Candidates are screened with a clinical and neurological examination.~      Participants are randomly assigned to one of two groups - precision or non-precision hand~     movements. All participants undergo the following procedures:~        -  Force precision task: Subjects are press a small device between the thumb and index~          finger. The force produced with the fingertips is translated onto a computer screen.~          Subjects track a white line passing on the screen with their fingertips.~        -  Paired-pulse transcranial magnetic stimulation (TMS): A wire coil is held to the~          subject's scalp. A brief electrical current is passed through the coil, creating a~          magnetic pulse that stimulates the brain. During the stimulation, the subject may be~          asked to tense certain muscles slightly or perform other simple actions. The stimulation~          may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click~          and feel a pulling sensation on the skin under the coil. The effect of paired-pulse TMS~          on the muscles is detected with electrodes taped to the skin on the arms or legs.~        -  Surface electromyography (EMG): This test measures the electrical activity of muscles.~          For this test, electrodes are filled with a gel and taped to the skin over the muscle to~          be tested.~      The study involves six sessions. Sessions 1-5 are on consecutive days; session 6 is one week~     after session 5.~        -  Session 1: Familiarization with the motor task and baseline measurements, including~          error rate, EMG, and paired-pulse TMS~        -  Session 2: Training in the motor task and repeat measurements as in session 1~        -  Session 3: Training and measurements as in session 2~        -  Session 4: Training and measurements as in session 2~        -  Session 5: Training and measurements as in session 2~        -  Session 6: Measurements only~   "
248843|NCT00295555|"~     Few studies have reported the effect of alpha1-adrenergic antagonists on 24-h blood pressure~     and regulation of sympathetic nervous activity in hypertensive patients with diabetic~     nephropathy. Using ambulatory blood pressure monitoring devices equipped with spectral~     analysis of heart rate variability, we assess the effects of doxazosin on blood pressure in~     diabetic nephropathy patients and compare the results with those in patients with essential~     hypertension, patients with diabetes mellitus and patients with chronic nephropathy.~   "
248844|NCT00295542|"~     The MAPEC study was designed to investigate whether normalizing the circadian blood pressure~     profile towards a more dipper pattern (increasing the diurnal/nocturnal ratio of blood~     pressure) by the use of Chronotherapy (that is, taking into account the time of day of~     administration of antihypertensive medications) reduces cardiovascular risk.~   "
248845|NCT00295529|"~     There is an urgent need for a knowledge translation strategy to facilitate the integration of~     genetics into family medicine, to improve the low knowledge base of most Canadian family~     physicians, ensure that the needs are met of those in the population who could benefit from~     genetic assessment, and facilitate evidence-based decision-making in the face of increasing~     patient demand.~      We have developed a multi-faceted intervention incorporating three distinct knowledge~     translation strategies: interactive educational sessions, a portfolio of tools for use in~     clinical practice and an innovative, efficient, information technology-based knowledge~     service designed to provide timely (just-in-time) information which reflects both topical~     genetics issues and the pattern of users' queries (a so-called push-pull approach).~      We hypothesize that a multi-faceted knowledge translation intervention will improve the~     delivery of genetics services by family physicians.~   "
248846|NCT00295516|"~     In pregnancies complicated by Rhesus disease, the mother has developed antibodies which cross~     the placenta and can cause anemia and death of the fetus. When the anemia is detected on~     time, the fetus can be saved by giving it blood transfusions during the pregnancy.~      The standard test to predict whether the fetus needs a blood transfusion is examination of~     the amniotic fluid. To obtain this fluid a needle has to be inserted in the womb, which has a~     risk of preterm delivery, infection, and making the disease worse. This is called~     amniocentesis.~      A new safe test, using Doppler ultrasound, has been developed to possibly replace the~     amniocentesis.~      The aim of this study is to compare the new Doppler test with the standard amniocentesis. If~     the Doppler test is at least as good, this safe test may replace the amniocentesis in the~     management of pregnancies with Rhesus disease.~   "
248847|NCT00295503|"~     To estimate the time to progression of cancer in patients with previously untreated~     mesothelioma receiving cisplatin, pemetrexed and bevacizumab~   "
248856|NCT00295373|"~     The purpose of this study is to determine whether the effects of rosuvastatin treatment and~     exercise training can be synergistic, with respect to the innate immune receptor TLR4,~     markers of systemic inflammation, and stimulated production of inflammatory cytokines, in~     hypercholesterolemic subjects. It is hypothesized that a rosuvastatin and exercise~     intervention will synergistically lower measured variables, so as to be anti-inflammatory.~   "
248857|NCT00295360|"~     The expression of transporters involved in bile acid homeostasis is differentially regulated~     during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter~     breast cancer resistance protein (BCRP) that is highly expressed in the human intestine.~     Therefore we intend to analyze whether intestinal BCRP expression could be altered during~     cholestasis.~   "
248942|NCT00294229|"~     Context: Acute low back pain (LBP) is a common reason for consultations in primary care.~     Reducing the pain in the first hours and days and restoring the functional capacity of the~     lumbar spine may result in a decrease in medical costs and earlier return to work.~      Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute~     low back pain.~   "
248848|NCT00295490|"~     Osteoarthritis of both the knee and hip joints are common conditions; knee osteoarthritis~     affects 6% of adults over 30 years of age and osteoarthritis of the hip affects between 3%~     and 6% of the Caucasian population. Both forms of osteoarthritis are associated with~     disability. Conventional treatment (analgesics and the use non-steroidal anti-inflammatory,~     NSAIDS) is prophylactic, aimed at decreasing pain and improving function. However long term~     use of NSAIDS is associated with a high incidence of adverse events (gastrointestinal tract~     symptoms). A safer alternative treatment would therefore be beneficial.~      Both anecdotal evidence and recent studies have implicated the potential of the herbal remedy~     Devil's Claw (Harpagophytum procumbens) for the treatment of painful, chronic arthritic type~     conditions (Ernst and Chrubasik, 2000). Devil's Claw is an extract obtained from the root of~     the Harpagophytum procumbens plant, a member of the sesame family found in the Kalahari~     region in South Africa. It has been shown that this herbal remedy has anti-inflammatory and~     analgesic effects (Baghdikian et al, 1997). Currently Devil's Claw is marketed for use as a~     supportive treatment of degenerative arthrosis, is not a Medicines Control Agency licensed~     product and is freely available to the general public in health food stores and pharmacies.~      The objectives of this study are to assess the efficacy, optimum dosage and safety of the~     herbal remedy Devil's Claw (Harpagophytum) in the treatment of osteoarthritis of the knee~     and/or hip. The primary objective of this study is to investigate the following three~     principal questions:~        1. To compare the efficacy of Devil's Claw with placebo in the treatment of osteoarthritis~          of the knee and/or hip~        2. To determine the optimum dose of Devil's Claw and~        3. To evaluate the safety and tolerability of three doses of Devil's Claw in the treatment~          of osteoarthritis of the knee/hip and to compare them to placebo There are also a number~          of secondary research objectives that will also be addressed (see later).~      These objectives are based on the following hypotheses :~      Hypotheses~        -  Devil's Claw has anti-inflammatory properties (as assessed by the reduction in pain,~          stiffness and disability aspects on the WOMAC) in chronic osteoarthritis of the knee~          and/or hip after 16 weeks of treatment, as compared to placebo.~        -  A dose response effect exists in the treatment of osteoarthritis of the knee/hip by~          Devil's Claw.~   "
248849|NCT00295477|"~     The study is intended for individuals who are doing well on HAART therapy. In Step 1 of the~     trial, individuals will be given up to 6 infusions of the study drug VRX496 to see the effect~     on viral load and CD4 counts. If individuals have no serious adverse effects from the~     infusions of VRX496 and the viral load and CD4 counts remain stable, they may go on to Step 2~     of the study. In Step 2, individuals will stop taking their HAART medication and their viral~     load, CD4 counts and the number of VRX496 in T cells will be monitored.~      All subjects who receive VRX496 T cells will enroll in a Long-Term Follow-up study to monitor~     subjects. Subjects will be followed every 6 months for five years following the 1st infusion~     of the T cells. If the VRX496 T cells are no longer found in the blood after five years, then~     subjects will be contacted yearly for the next 10 years. If the VRX496 T cells are found in~     the blood at five years after the 1st infusion of T cells, then the subjects will continue to~     be seen once a year until the VRX496 T cells are no longer found in the blood for a maximum~     of 15 years.~   "
248850|NCT00295464|"~     Administration of steroid to the mother in imminent preterm delivery is a known effective~     practice to decrease the risk of respiratory distress syndrome and intraventricular~     haemorrhage in preterm infants if given with a week of the preterm delivery. This randomized~     clinical trial is performed to test the possibility whether the repeat dose of steroid~     results in further reduction of these diseases in case the mother is in imminent preterm~     delivery more than a week after the first antenatal steroid treatment.~   "
248851|NCT00295438|"~     The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in~     thoracoabdominal trauma using two different echographic methods. The first method is a~     robot-based tele-echography performed by radiologists in a remote location. The second is~     bedside echography performed by emergency physicians according to the FAST (Focussed~     Assessment by Sonography of Trauma) examination.~   "
248852|NCT00295425|"~     Psoriasis is an immuno-mediated skin disorder, which affects about 2-3% of the population~     worldwide. For moderate-severe forms of psoriasis systemic immunosuppression is the treatment~     of choice. This clinical trial was initiated to compare the safety and effectiveness of~     mycophenolate mofetil and cyclosporine A for the treatment of psoriasis. Patients are~     randomized to receive either 2.5 mg/kg BW cyclosporine A or 1 g bid mycophenolate mofetil. If~     after six weeks no decrease in the PASI score occures cyclosporine A doses are increased to 5~     mg/kg BW for additional six weeks. In the other arm mycophenolate mofetil is increased to 1 g~     tid for additional six weeks.~   "
248853|NCT00295412|"~     The lifetime of substance use disorders in schizophrenia is close to 50%. Substance abuse in~     schizophrenia is associated with negative consequences. Unfortunately, there no clear~     guidelines for the pharmacological treatment of this dual diagnosis population. Preliminary~     results suggest that second-generation antipsychotic drugs (mainly clozapine) may relieve~     drug cravings in schizophrenia. We performed a 12-week pilot study to evaluate the impact of~     quetiapine, a second-generation antipsychotic, on substance abuse parameters, psychiatric~     symptoms and side effects in patients schizophrenia and comorbid substance use disorders. Our~     expectation was a 20 % decrease in drug cravings from baseline to end-point.~   "
248854|NCT00295399|"~     The goal of this project is to develop a low-cost, user-friendly, portable telerehabilitation~     system for physical therapy of the upper limb after stroke or traumatic brain injury. The~     system is based on the use of a commercially available force feedback joystick and will work~     with an ordinary home PC and a standard high-speed internet connection. Using the joystick,~     the patient will perform exercises designed to aid in recovering motor function of the hand~     and arm. The joystick will be programmed to either assist or resist the patient's movements.~     The system will include sophisticated analysis of patient status and progress to provide the~     therapist and physician with detailed information. In the first phase of the study, we will~     develop the system in cooperation with the physical therapy staff and other rehabilitation~     specialists. The investigators will examine the usability, comfort, safety and therapeutic~     benefit of the system. In the second phase of the study, the investigators will employ the~     system in patients' homes, using the internet to connect to rehabilitation specialists in the~     clinic. The study hypothesis is that it is possible to adapt commercially available, low cost~     gaming equipment such as force feedback joysticks to provide therapy for patients in their~     own homes, and that patients will be able to work with this system and will find it enjoyable~     and helpful for recovering motor function.~   "
248855|NCT00295386|"~     The present study examines the short- and long-term clinical efficacy of cognitive-behavior~     therapy and pharmacological treatment in patients suffering from late-life primary insomnia.~     46 subjects suffering from chronic primary insomnia were randomized into either~     cognitive-behavior therapy (CBT, n=18), hypnotics (7.5 mg Zopiclone, n=16), or placebo~     treatment (n=12). All active treatments lasted 6 weeks with follow-ups conducted at 6 months.~     Ambulant clinical polysomnography (PSG) and sleep diaries were used on all three assessment~     points.~   "
248943|NCT00294216|"~     The purpose of this study is to investigate the effect of intake of Omacor (Omega-3-acid~     ethyl ester 90) 2g/day on specified parameters related to the stability of carotid plaque in~     patients awaiting endarterectomy.~   "
248858|NCT00295347|"~     The proposed research aims to compare the onset of action and the efficacy of~     fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid~     antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in~     65 inpatients with severe depression. The study will also explore the utility of the~     hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be~     a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo~     during three years.~   "
248859|NCT00295334|"~     Our specific aim is to explore the effect of moderate alcohol intake on parameters of~     glycemic index and lipid profile among patients with type 2 diabetes.~   "
248860|NCT00295308|"~     Background:~        -  Though the drug buprenorphine effectively treats dependence on opioids like heroin, some~          abstinent patients relapse to use during treatment. This relapse may be triggered by~          stress or stressful situations, and buprenorphine probably has no specific protective~          effect in these situations. Buprenorphine probably also has no specific effect on~          relapse to cocaine use.~        -  Research has shown that clonidine, a drug originally prescribed to treat high blood~          pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse~          to heroin and cocaine seeking in rats. Researchers are interested in studying whether a~          combination of clonidine and buprenorphine may be more effective in preventing drug~          relapse than administering one of the medications alone.~      Objectives:~      - To determine whether clonidine, given to abstinent patients maintained on buprenorphine, is~     more effective than placebo in preventing relapse to heroin or cocaine use.~      Eligibility:~      - Individuals between 18 and 50 years of age who are current cocaine or heroin users seeking~     treatment.~      Design:~        -  The study will last up to 36 weeks, with four phases of treatment and a follow-up~          evaluation. Three times a week, participants will be asked to report illicit drug use~          and provide urine and breath samples. Throughout the study, participants will receive~          individual counseling in weekly 40 60 minute sessions. Other samples and tests will be~          scheduled as required by the study researchers.~        -  Patients will be stabilized on daily buprenorphine over the first 14 days of the study.~        -  Weeks 1 8: Participants will receive vouchers for regular substance-free urine samples.~          Those who successfully complete this phase will continue to the next part of the study.~        -  Weeks 7 9: Participants will receive either clonidine or placebo along with the~          buprenorphine. The dose of clonidine will be stabilized during this time.~        -  Weeks 9 22: Participants will continue to receive either clonidine or placebo along with~          the buprenorphine. During this part of the study, participants will keep electronic~          diaries to record drug use or craving and to record data on mood, stress levels, and~          activity.~        -  Weeks 23 28: Participants will stop taking the clonidine or placebo, but will continue~          the buprenorphine treatment. Participants will continue to keep electronic diaries.~        -  Weeks 29 36: Participants will have the choice of transferring to a community clinic~          transfer or gradually reducing doses of buprenorphine to end the study.~        -  Participants will return for a follow-up visit and urine sample 6 months after the end~          of the study.~   "
248861|NCT00295295|"~     Cerebral palsy is a group of disorders characterized by lack of coordination in the muscles,~     loss of movement, and speech disturbances. These disorders are caused by injuries to the~     brain that occur during fetal development or near the time of birth. The purpose of this~     study is to determine the effects of high frequency, low magnitude vibration on bone and~     muscle in children with cerebral palsy.~   "
248862|NCT00295282|"~     This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be~     enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg.~     Three to six patients will be enrolled at each dose level, starting at the lowest dose level,~     for a maximum of 24 patients to be enrolled into the study. The study is designed to~     establish the safety and tolerability of single doses of MDX-1100 administered in~     dose-escalating cohorts to patients with ulcerative colitis. Other study objectives include~     characterizing a pharmacokinetic profile and pharmacodynamic effects of MDX-1100 and~     determination of immunogenic response to MDX-1100.~   "
248863|NCT00295269|"~     The purpose of this study is to assess innovative treatment methods in patients with adult~     respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.~   "
248864|NCT00295256|"~     The management of high-risk pregnancies require substantial use of medical resources. Our~     goal is to determine the effectiveness of a nurse case management program in which case~     managers are assigned to patients with high-risk conditions.~      Our hypothesis is that women with diabetes in pregnancy or hypertension who are assigned a~     nurse case manager will have lower glucose levels and lower blood pressure levels~   "
248865|NCT00295243|"~     Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will~     be given Topotecan intravenously on Days 1, 8 and 15.~   "
248866|NCT00295230|"~     Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes~     of ventilation is not only feasible but also advantageous for providing more constant and~     desirable mechanical breath size. This ideally minimizes ventilator-induced lung injury due~     to barotrauma and volutrauma. To date, only one recent study has investigated the relative~     advantages of combining VG with different modes of synchronized mechanical ventilation in~     clinically stable, preterm infants that were mechanically ventilated at an average age of one~     month. We aim to further evaluate the effects of PSV+VG versus SIMV+VG ventilation in very~     low birth weight infants within the first three to five days of life. Our hypothesis is that~     in very low birth weight infants requiring mechanical ventilation in the first three to five~     days of life, PSV+VG will allow for more stable physiologic and ventilatory parameters~     compared to SIMV+VG. The primary endpoints are a reduction in respiratory rate and average~     mean airway pressure in the PSV+VG group compared to the SIMV+VG group.~   "
248867|NCT00295217|"~     The goal of this study is to validate the new ExAblate Application software V4.2 by~     developing additional data that shows the safety of this treatment. The ExAblate is intended~     to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine~     fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less~     than 24 weeks and not seeking treatment for reasons of improving fertility.~   "
248868|NCT00295204|"~     Comparing the arrhythmia diagnostic yield of MCOT as compared to standard loop event monitors~     in patients presenting with palpitations, syncope or near syncope occurring less frequently~     than every 24 hours. Patients randomized and are enrolled for 30 days. Prior testing~     required: 24 hours of non diagnostic monitoring,~   "
248869|NCT00295191|"~     This study aims to investigate the effects of high flux dialyser use and ultra pure dialysate~     utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality,~     progression of carotid artery intima-media thickness and coronary artery calcifications,~     inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in~     hemodialysis patient population. It is hypothesized that both interventions in this project~     may diminish cardiovascular disease in hemodialysis patients.~   "
248889|NCT00294931|"~     This multicenter phase II trial is designed to study the unique combination of chemotherapy~     (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical~     setting seems ideal for evaluation of the role of bevacizumab in delaying progression and~     prolonging survival.~   "
248944|NCT00294203|"~     This pilot study is looking at how well epoetin alfa, given in the immediate post-operative~     period, works in reducing anemia and the need for transfusions.~   "
248870|NCT00295178|"~     This study is designed to investigate the difference in speed and degree of symptom~     resolution between daptomycin and vancomycin in subjects treated for cellulitis or erysipelas~     by evaluation of the following parameters:~        -  Time to erythema margin cessation to progress~        -  Time to defervescence~        -  Time to hospital discharge following relief of the presenting cellulitis or erysipelas~        -  Degree of improvement of the following signs and symptom of cellulitis or erysipelas~          including~        -  Degree of improvement of cellulitis-related pain and swelling as reported by subjects~      Additionally, the difference in frequency of Adverse Events between daptomycin and vancomycin~     will be described.~   "
248871|NCT00295165|"~     The purpose of this study is to evaluate if Leukine can induce clinical response or remission~     in patients with Crohn's disease.~   "
248872|NCT00295152|"~     The purpose of this study is to determine the effects of community occupational therapy in~     older patients with mild ot moderate dementia and their primary caregivers.~   "
248873|NCT00295139|"~     The main purpose of this study is to determine if the multifaceted treatment for substance~     abuse in dual disordered patients is more effective in reducing drug use than a supportive~     control treatment. The researchers will also determine if adding a case management component~     (Critical Time Intervention; CTI) to the intervention will increase treatment engagement and~     retention.~   "
248874|NCT00295126|"~     This is a randomized open label trial that evaluates the efficacy of an autologous platelet~     concentrate (APC) in pre-implantation reconstruction of maxilla.~      The sinus occlusion will be performed under general anaesthetic. On one side by the usual~     technique with hipbone transplant, the other side will be restored with APC mixed with~     autologous bone tissue removed from the surgery site.~      The side selection will be determined by the randomization.~   "
248875|NCT00295113|"~     The aim of the study is to observe the ventilatory and cardiac function (included the~     pulmonary arterial pressure) during an intermittent work exercise test with high density work~     load.~   "
248876|NCT00295100|"~     The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial.~     Study participants will be randomly assigned to receive either tamoxifen or placebo for one~     year. Participants will subsequently be followed for one year off of medication. The primary~     objective is to evaluate the effectiveness of tamoxifen in reducing breast density by~     mammogram.~   "
248877|NCT00295087|"~     Women who are affected with premature ovarian failure will exhibit skewed X-chromosome~     inactivation patterns compared to women with normal menstrual function (as defined by being~     pregnant), indicating a possible X-chromosome defect.~   "
248878|NCT00295074|"~     Mild traumatic brain injury (TBI) is a common injury that can produce significant functional~     sequelae and ongoing disabling symptoms. Predicting who will have an uncomplicated recovery~     and who will suffer ongoing symptoms is difficult. This protocol evaluates the use of~     neuropsychologic testing after mild TBI in injured patients to attempt to objectively~     establish predictors of long term disability and functional recovery.~   "
248879|NCT00295061|"~     The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1~     Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1~     Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult~     Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug~     on a weekly schedule for 24 weeks.~   "
248880|NCT00295048|"~     The purpose of this study is to evaluate the efficacy of an innovative, computer driven~     cognitive rehabilitation program for individuals with schizophrenia and related disorders.~   "
248881|NCT00295035|"~     Colorectal cancer is a major health concern in the Western world with an estimated lifetime~     risk of 5-6%. The goal of achieving effective cancer prevention is driven by the prediction~     that CRC will become the leading cause of death (surpassing heart disease) in this decade,~     with an estimated 1,000,000 new cases and over 500,000 deaths per year, worldwide. Despite~     continuing advances in diagnosis and therapy, long-term survival rates have not improved~     significantly over the last four decades. Nearly 50% of all CRC patients will die of the~     disease. Preventive strategies offer the best hope, at least until our understanding of the~     biology of cancer matures to the point where it can be implemented into therapy. The search~     for new chemopreventive compounds with minimal toxicity raises particular interest in~     phytochemicals.Curcumin (diferuloylmethane) is a natural compound derived from the rhizome of~     Curcuma Longa, an East Indian plant, commonly called turmeric. It has been shown to possess~     potent anti-inflammatory and anti-oxidative properties, for which it has a long history of~     dietary use as a food additive. Curcumin has also a potent anti-proliferative effects against~     a variety of cancer cell lines in vitro, which stem from its ability to modulate many~     intracellular signal transduction pathways. Human phase I-II studies found curcumin to be~     safe, and indicated no dose-limiting toxicity when taken by mouth at doses up to 10 g/day.~     This data, together with the dismal therapeutic options available for colon cancer patients,~     suggest that curcumin warrants investigation in this setting. The present study evaluates~     gemcitabine in combination with curcumin and celecoxib for patients with colon cancer.~   "
248882|NCT00295022|"~     To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of~     seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an~     environmental exposure unit.~   "
248883|NCT00295009|"~     The objective of this clinical investigation is to compare the safety and effectiveness of~     ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain~     associated with DDD in the lumbosacral spine. There will be separate study arms for one and~     two level cases.~   "
248884|NCT00294996|"~     The purpose of the study is to examine the safety and effectiveness of the drug combination~     of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet,~     as first line treatment for patients with metastatic HER2+ breast cancer.~   "
248885|NCT00294983|"~     Estimating the prevalence of OCD symptoms among patients with burns~   "
248886|NCT00294970|"~     Cognitive profile of patients who suffer both from PTSD and OCD, as compared to those who~     suffer from PTSD or OCD without other comorbidity.~   "
248887|NCT00294957|"~     Assessing the psychological and physiological status of Israeli former prisoners of war~     (POW).~   "
248888|NCT00294944|"~     Assessing the effectiveness of Idazoxan as a treatment for depressive patients who did not~     respond to treatment with SSRI~   "
248890|NCT00294918|"~     This is an open-label, multi-center, randomized, parallel-group, maintenance trial of~     Serostim® in subjects who have completed a prior Serostim® Human Immunodeficiency~     Virus-associated Adipose Redistribution Syndrome (HARS) trial (Study 22388). The subjects,~     who encountered toxicity during the antecedent protocol, will be assigned to a 1 milligram~     (mg) dose. All other subjects will be randomized in 1:1 ratio, to receive up to 2 mg or 4 mg~     of Serostim®, beginning from Day 1 of Week 1. Doses will be adjusted downward in subjects~     weighing less than 55 kilogram (kg). Serostim® therapy will be continued at the assigned~     doses through Week 12 (Period 1). Subjects, who will encounter toxicity during Period 1, will~     be assigned to the 1 mg group for Period 2. All other subjects will be randomized in a 1:1~     ratio to receive up to 2 mg or 1 mg of Serostim® on a weight adjusted basis. Period 2 therapy~     will begin on Day 1 of Week 13, continuing through Week 36. Study visits are required at~     Screening (that is, Final Visit of the antecedent trial), Day 1 of Week 1 (Baseline), and at~     Weeks 2, 6, 12, 14, 24, 30 and 36.~   "
248891|NCT00294905|"~     A controlled study demonstrated that a smoking cessation protocol in routine primary care,~     specifically targeted at patients with COPD (SMOCC), doubled the quit rates. The protocol was~     tested under optimal trial conditions, but it is unclear if a large-scale implementation~     strategy is (cost-)effective. Therefore the present study investigates a large scale~     implementation strategy in a 2-armed community intervention trial. The research question is~     how (cost-)effective this implementation strategy is compared to usual implementation~     procedures.~   "
248892|NCT00294892|"~     Primary~        -  pharmacokinetics of single dose nevirapine~        -  the effect of single dose carbamazepine on the pk of single dose nevirapine~        -  resistance against nevirapine before and after.~        -  follow-up on HIV status newborns~        -  relation between nevirapine levels in cord blood and plasma~      Secondary~      * safety of single dose nevirapine and nevirapine/carbamazepine~      Hypothesis:~      Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive~     pregnant Tanzanian women by decreasing nevirapine half-life.~   "
248893|NCT00294879|"~     Introduction Pressure Support Ventilation is widely used in patients in the ICU. Matching the~     patient's respiratory needs with adequate ventilator settings is necessary to ensure a low~     work of breathing (WOB) and maximal patient comfort. The inspiratory rise time (IRT)~     determines the time to reach the selected airway pressure. A short IRT results in a high peak~     inspiratory flow and a short time to reach that peak, but is also associated with the~     development of turbulent flow, resulting in increased WOB. Aim of this study is to~     investigate the effects of different IRT settings on WOB and patient comfort during pressure~     support ventilation.~      Methods We will performed a prospective, single blind cohort study in patients on Pressure~     Support Ventilation. 10 healthy adult patients admitted to the ICU after elective facial or~     neck surgery will be included. All patients will be ventilated in pressure support mode using~     a Servo 300 ventilator (Siemens. Elema, Solna, Sweden), with a positive end expiratory~     pressure of 5 cm H2O, pressure support level of 12 cm H2O above PEEP and an inspiratory~     oxygen fraction of 0.40. Patients have to be awake and cooperative (Ramsay 2). WOB will be~     measured with an esophageal balloon, and miniature flowmeter (Bicore system). Breathing~     comfort will be evaluated using a visual analogue scale (VAS) ranging from 1 to 10. WOB and~     patient comfort will be measured (in random order) at 0, 5, and 10% IRT. For statistical~     analysis the two-way analysis of variance will used. A p value of < 0.05 will be considered~     statistically significant.~   "
248894|NCT00294866|"~     Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory~     markers which may contribute to the high rates of cardiovascular disease and mortality seen~     in these patients. Vitamin D use in dialysis patients has been shown to have a survival~     benefit, with paricalcitol at advantage over calcitriol. Since there is some evidence for~     involvement of the vitamin D receptor in inflammation, this study is designed to look for an~     effect of paricalcitol on markers of inflammation in hemodialysis patients.~   "
248895|NCT00294853|"~     The purpose of the study is to determine if calcium score can be used as a predictor of~     coronary artery disease in heart transplanted patients, as it is used in non-transplanted~     persons.~   "
248896|NCT00294840|"~     To assess a quantitative kinetic model of FDG uptake measurement using PET in patients with~     aggressive Non-Hodgkin's lymphoma and cancer of the pancreas, malignancies with known~     variability in disease aggressiveness and prognosis, for optimized tailoring of the~     therapeutic strategy in the individual patient.~   "
248897|NCT00294827|"~     Survival of colo-rectal cancer patients after liver transplantation.~   "
248898|NCT00294814|"~     The purpose of this study is to test the hypothesis that using three different techniques to~     anastomose coronary grafts to the aorta: partial occlusion, single cross clamp, or using the~     Heartstring anastomotic device, will change the amount of gas and solid microemboli as~     detected by the EmbodopR transcranial Doppler (TCD) system and consequently the~     neurocognitive performance of patients after coronary bypass operation.~   "
248899|NCT00294801|"~     comparative trial of placebo versus flex-a-new (a food supplement) containing glucosamine an~     chondroitin sulfate for the symptom modification is knee osteoarthritis~   "
248900|NCT00294788|"~     This project aims to test the hypothesis that oral consumption of a specific strain of the~     probiotic bacterium Lactobacillus fermentum (trademarked PCC®) is able to significantly~     enhance the immune response to a vaccine for influenza.~   "
248916|NCT00294580|"~     A trial was conducted in the 1980s to compare two strategies for control of malaria in young~     children aged 3-59 months: treatment with chloroquine versus treatment combined with~     fortnightly chemoprophylaxis with Maloprim. The impact on mortality and morbidity was~     assessed at the time, and their cognitive abilities and educational outcomes were assess 14~     years later in 2001. The hypothesis was that the chemoprophylaxis would reduce morbidity and~     mortality and would improve cognitive abilities and educational outcomes in the long term~   "
248917|NCT00294567|"~     In patients with hypertension who undergo elective PCI, the effects of long-term~     administration of Calblock (azelnidipine) on plaque volume will be determined quantitatively~     by 3D-IVUS and compared with those of amlodipine besilate (Norvasc or Amlodin).~   "
248975|NCT00293787|"~     The purpose of the study is to evaluate the safety and effectiveness of an investigational~     therapy for treating patients with open-angle glaucoma or ocular hypertension.~   "
248901|NCT00294775|"~     The consequence of aortic valve stenosis (AVS) is increased pressure load on the left~     ventricle which causes left ventricular (LV) hypertrophy, and myocardial stretch will cause~     activation of cardiac peptides and activation of the renin angiotensin aldosterone system~     (RAAS). The consequence of LV hypertrophy is increased chamber-stiffness and delayed active~     LV relaxation which initially will cause diastolic and later systolic dysfunction. In heart~     failure (HF) and ischemic heart disease the degree of diastolic dysfunction has been~     demonstrated to correlate with functional class, neurohormonal activation and prognosis which~     also recently have been suggested for AVS.~      With longstanding elevated filling pressures the left atrium (LA) will dilate. Only limited~     data are available on the degree and importance of LA dilatation in AVS.~      When apparent, symptoms of HF in AVS are associated with high mortality rates. If LV systolic~     dysfunction also is present prognosis will deteriorate further. In these cases aorta valve~     replacement (AVR) is recommended. AVR will normalize pressure overload and thereby decreases~     LV hypertrophy. Previously it was believed that in time LV hypertrophy regressed towards~     normal and even normalized. Recent studies however have demonstrated that LV hypertrophy~     regression mainly happens during the first year after AVR, and little subsequent changes are~     seen during the remaining 10 years. Furthermore, patients that experience most regression of~     hypertrophy have more favourable outcome and better functional class than patients with less~     regression of hypertrophy. Thus absence of reverse remodelling is associated with poor~     outcome after AVR. Importantly the regression of LV hypertrophy is closely paralleled by~     decreasing RAAS hyperactivity.~      RAAS hyperactivity may be attenuated pharmacologically with angiotensin II receptor blockers~     (ARB) which in systemic hypertension with LV hypertrophy has been associated with reverse~     remodelling.~      The hypothesis is that in patients undergoing AVR for symptomatic AVS, 12 months post~     operative blockade of the angiotensin II receptor will accelerate LV and LA reverse~     remodelling, reduce filling pressures and suppress neurohormonal activation compared with~     conventional therapy. This will lead to improved exercise tolerance and due to improved left~     atrial function reducing the risk of atrial arrythmias.~   "
248902|NCT00294762|"~     This will be the first prospective study where patients will be selected on the basis of two~     measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess~     prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy~     in highly selected patients with EGFR overexpression and/or EGFR amplification.~   "
248903|NCT00294749|"~     The purpose of this study is to determine whether long antibiotic prophylactic is more~     effective than a short traitement in infective complications for prostate biopsy~   "
248904|NCT00294736|"~     This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in~     patients with advanced NSCLC who currently smoke.~      Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers.~      In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD~     established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be~     treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is~     open as of Nov-2006.~   "
248905|NCT00294723|"~     This trial is conducted in North America (the United States of America (USA) and Mexico).~      The trial is designed to evaluate the effects of treatment with liraglutide versus~     glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind~     trial period plus a 52-week open-label extension (week 104) followed by an additional~     156-week continued open-label extension. The total duration of the treatment period is~     planned to be 260 weeks (5 years).~   "
248906|NCT00294710|"~     This study is designed to compare the long-term efficacy and safety of an aliskiren based~     regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients~     with essential hypertension~   "
248907|NCT00294697|"~     Our overall hypothesis is that genetic variations in innate immunity genes predispose~     patients to varying responses after injury by altering the systemic and local inflammatory~     responses. In addition, we hypothesize that these genetic differences are associated with~     different clinical outcomes~   "
248908|NCT00294684|"~     The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical~     trial to evaluate whether long-term treatment with corticosteroids improves the outcome of~     the Kasai or gall-bladder Kasai in infants with biliary atresia. In this clinical trial,~     ChiLDREN is testing whether corticosteroid therapy following the Kasai will improve bile~     drainage and long term outcome in infants with biliary atresia. Subjects in this trial must~     start treatment within 72 hours of the Kasai procedure and be part of a prospective study of~     the natural history of biliary atresia also being conducted by ChiLDREN~     (http://www.clinicaltrials.gov/ct/show/NCT00061828?order=3).~   "
248909|NCT00294671|"~     The purpose of this study is to determine if diflunisal can prevent progressive lower leg~     nerve damage in patients with familial amyloidosis polyneuropathy.~      Funding Source - FDA Office of Orphan Products Development (OOPD); National Institute of~     Neurological Disorders and Stroke (NINDS)~   "
248910|NCT00294658|"~     The purpose of this trial is to determine if thymectomy combined with prednisone therapy is~     more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.~   "
248911|NCT00294645|"~     The purpose of the study is to compare remote pacemaker follow-up to current standard of care~     follow-up. The study will compare the rate of first diagnosis of clinically actionable events~     between patients who utilize the Medtronic Carelink® Network (Remote arm) versus patients who~     are followed via routine office visits augmented by transtelephonic monitoring (TTM)(Control~     arm).~   "
248912|NCT00294632|"~     The goal of this clinical research study is to find the highest tolerable dose of the drug~     lenalidomide (Revlimid, lenalidomide) that can be given with Rituxan® (rituximab) in the~     treatment of relapsed mantle cell lymphoma. The safety and effectiveness of this combination~     treatment will also be studied in both mantle cell lymphoma and diffuse large B-cell~     non-Hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma~     (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).~   "
248913|NCT00294619|"~     The purpose of this study is to evaluate efficacy and safety profile of a new weekly~     administered growth hormone preparation compared with placebo in adults with growth hormone~     deficiency.~   "
248914|NCT00294606|"~     This will be a prospective, randomized, double-blinded, cross-over clinical trial to compare~     the effects of phenylephrine or norepinephrine on cardiac function during carotid artery~     surgery in patients under general anesthesia. The effect of the vasopressor on cardiac~     function will be measured using electrocardiography, transesophageal echocardiography and~     cardiac troponin I intraoperatively and postoperatively. We will use a cross-over pattern~     since both drugs exhibit rapid onset and short duration of action. We hypothesize that there~     will be less myocardial ischemia associated with the use of norepinephrine when compared with~     phenylephrine during carotid artery surgery.~   "
248915|NCT00294593|"~     The purpose of this study is to determine whether folinic acid can improve developmental~     quotient of young Down syndrome patients, given that these present signs of folate deficiency~     which are known to cause reversible neurological, psychiatric and cognitive disorders.~   "
248918|NCT00294554|"~     The purpose of this research is to evaluate the usefulness of memantine, compared to placebo~     (sugar pill), for the treatment of cognitive impairment in patients with idiopathic~     Parkinson's disease (PD) and dementia. Memantine is used as a safe and effective treatment~     for patients with Alzheimer's disease. Cognitive impairment includes concentration and memory~     difficulties. We will look at how well this medication helps your cognitive impairment, how~     well you tolerate this medication (including its effects on your motor symptoms of PD) your~     activities of daily living, your emotions, and any medical conditions you might have. We will~     interview a person you choose as your informant.~   "
248919|NCT00294541|"~     This trial is a follow-up companion study to Protocol ICA-17043-10, a Phase III,~     multi-center, efficacy and safety study of ICA-17043. This is an open-label extension study~     collecting safety data on the use of ICA-17043 in subjects with sickle cell disease (SCD)~     (e.g., HbSS, HbSC, HbSb0-thalassemia, HbSb+-thalassemia subjects). All subjects who have~     successfully completed ICA-17043-10 will, if deemed appropriate by their study Investigator~     and appropriate consent by subject is given, enroll in the ICA-17043-12 study (Study 12).~     Only patients who participated in ICA-17043-10 are eligible for this open label study~   "
248920|NCT00294528|"~     A randomized blinded study is conducted comparing 2 different knee prostheses. Range of~     motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are~     registered at intervals up to one year postop, where patients are informed on which~     prosthesis they received.~      We want to:~        -  determine whether an increased ROM is achieved with a high-flex knee compared to a~          standard knee~        -  and if so, does it matter~   "
248921|NCT00294515|"~     This study will determine the relative efficacy and safety of up to 100 days Valcyte~     prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of~     CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study~     treatment is 3-12 months and the target sample size is 100-500 individuals.~   "
248922|NCT00294502|"~     To study the efficacy of an antibacterial/anticoagulant solution instilled into the~     hemodialysis (HD) catheters after each treatment (“antibiotic lock solution - ALS”) to~     prevent catheter related bacteremia (CRB) and to salvage catheters with established CRB.~   "
248923|NCT00294489|"~     A relatively large proportion of patients with chronic HCV infection have normal or mildly~     elevated ALT. Many of these patients are not being treated, and are not being sent for a~     liver biopsy. The present study will determine the ability of Methcetin BreathID Test(MBIT)~     to detect those patients who will be candidates for anti-viral treatment, as an alternative~     measure for liver biopsy in decision-making prior to treatment in clinical hepatology.~   "
248924|NCT00294476|"~     The purpose of this study is to evaluate the safety and efficacy of IVIG in the treatment of~     metastatic cancer of the prostate, colon and melanoma.~   "
248925|NCT00294463|"~     Tibolone, a tissue-selective compound with a combination of estrogenic, progestogenic and~     androgenic properties, is used as an alternative for estrogen or estrogen plus progesterone~     hormone therapy for the treatment of symptoms associated with menopause and osteoporosis. The~     current study compares endometrial histology, biochemistry (hormone levels) and~     gene-expression profiles after short-term (21-days) treatment with tibolone, to the findings~     after treatment with estradiol-only (E2) and E2+Medroxyprogesterone Acetate (MPA) in healthy~     postmenopausal women undergoing hysterectomy for endometrial prolaps.~      Since short-term tibolone use results in increased spotting and bleeding but long-term~     treatment with tibolone has been shown to lead to an atrophic endometrium our hypothesis is~     that tibolone first displays a more estrogenic mode of action, which over time, is~     counterbalanced by tibolone's progestagenic properties~   "
248926|NCT00294450|"~     The purpose of this investigation is to carry out a clinical evaluation of a newly developed~     fistula pouching system's ability to function as a good pouch for fistulas, with the opening~     on the skin of the stomach or in a wound on the skin of the stomach.~   "
248927|NCT00294437|"~     To determine if therapy with Zometa® (zoledronic acid) 4mg will be effective in preventing~     the occurrence of bone metastases in prostate cancer patients at high risk of developing~     them. In addition, pain and analgesic scores and overall safety are to be evaluated~     throughout the study.~   "
248928|NCT00294424|"~     The aim of this study is to compare the cost-effectiveness of major joint replacement in~     patients with short and non-fixed (control group) waiting time (WT). After being placed on~     the waiting list, patients will be randomized into two groups through regular contact with~     the practice staff: (1) Patients with non-fixed waiting time (patient undergoes hospital's~     normal procedure from the date (s)he is added to the waiting list to the date of operation),~     and (2) patients with short waiting time (operated in maximum three months). The main~     question is: is it possible to improve the cost-effectiveness of major joint replacement by~     shortening waiting time?~   "
248929|NCT00294411|"~     The incidence of caesarean section has reached 15-20% in most developed countries.~     Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component~     of a strategy to reduce the caesarean section rate. Most medical literature has focused on~     the efficacy of VBAC in reducing the caesarean section rate and the physical safety of~     successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little~     is known about how the uncertainty of labour outcome and a failed VBAC impact on the~     psychosocial function of these women. What we do know is that antenatal depression and~     unplanned caesarean section are major risk factors for postpartum depression, which in turn~     is the major cause of maternal mortality in many developed countries including Hong Kong. We~     propose to study a cohort of women with a prior caesarean section and presenting with a~     subsequent pregnancy for care. After consent and recruitment, these subjects will be randomly~     assigned to have a repeat caesarean section or VBAC. The medical outcomes, overall~     satisfaction of the subjects with the care they received, and the short-term psychosocial~     function of these subjects will be studied. The result of this study will provide important~     information that would be useful in assisting women to decide the mode of delivery after a~     prior caesarean section. The Hypothesis is that there is a significant difference in~     psychosocial function between these 2 groups of patients.~   "
248976|NCT00293774|"~     A study to determine the effectiveness and safety of the use of metal-on-metal hip~     resurfacing (for example the birmingham hip) when compared to conventional total hip~     replacement.~   "
248930|NCT00294398|"~     Specific Aim:~      To determine whether a prescription for Inhaled Corticosteroids (ICS) added to standard~     Emergency Department (ED) discharge therapy for young children with persistent asthma~     symptoms increases ICS use and improves symptoms and quality of life over the months~     following the ED visit.~      Hypotheses:~      In a cohort of pediatric patients with persistent asthma discharged from the ED after an~     acute asthma exacerbation, a prescription for ICS will:~        1. Improve usage of ICS as measured by refill of a prescription within the first 2 months~          after the ED visit~        2. Improve symptom severity at two weeks after an ED visit as measured by days of cough,~          wheeze, missed school, daycare or work~        3. Improve patient and caregiver asthma-related quality of life during the 2 months~          following an ED visit measured by asthma Health Related Quality of Life (HRQL)~        4. Improve asthma control at 2 months as measured by a validated asthma instrument~   "
248931|NCT00294385|"~     The purpose of this study is to compare the Time To Disease Progression (TTDP) between those~     patients with unresectable, locally recurrent or metastatic breast cancer who are treated~     with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy~     of Docetaxel followed by Gemcitabine.~   "
248932|NCT00294372|"~     The general aim is to evaluate the antiviral activity and safety of increasing doses of oral~     administered RTV-boosted BILR 355 BS (75 mg and 150 mg twice daily) in HIV-1-infected,~     NNRTI-experienced patients, followed by 28 day combination therapy with Tipranavir or~     Lopinavir based HAART-regimen~   "
248933|NCT00294359|"~     Although it is possible to cure bowel cancer when it is detected at an early stage, in many~     cases it may spread to involve other organs and in these cases is generally incurable.~     Chemotherapy prolongs survival and improves quality of life in such patients, but standard~     chemotherapy for this disease has not been defined.~      There are several possible chemotherapy treatments for patients with bowel cancer, which has~     spread to other organs. However, these treatments are only partly effective and only work for~     a limited period of time. Most treatments are associated with a number of possible side~     effects which may have a detrimental effect on quality of life. Thus, it is imperative that~     more effective treatments with the lowest possible risk of side effects are developed.~      Previous studies have shown that the addition of a new type of antibody treatment~     (bevacizumab) to an intensive combination chemotherapy regimen improved survival in patients~     with advanced bowel cancer and extended the time before tumours began to grow. However,~     intensive chemotherapy is likely to only be a suitable treatment for a proportion of patients~     with bowel cancer, because intensive chemotherapy causes a high rate of side effects.~      This study compares a gentle chemotherapy treatment (capecitabine chemotherapy tablets given~     by mouth) with the combination of capecitabine and bevacizumab and the combination of~     capecitabine, bevacizumab and intravenous mitomycin C.~      It is expected that a gentle chemotherapy treatment or a gentle chemotherapy treatment~     combined with bevacizumab would be an appropriate treatment for both young and fit patients~     as well as older and less fit patients who would not easily tolerate intensive chemotherapy.~   "
248934|NCT00294346|"~     The purpose of this study is to look at the safety and effectiveness of an investigational~     drug (AV608) when used in subjects who have Social Anxiety Disorder. AV608 is an NK-1~     receptor antagonist that exhibits central nervous system activity after oral administration.~     The study will compare AV608 to placebo (a medically inactive substance) to see if AV608~     helps the symptoms of Social Anxiety Disorder. Eligible subjects will be assigned by chance~     to take either AV608 or placebo for 12 weeks. During the study, subjects will be asked about~     their overall health and mood and their Social Anxiety Disorder.~   "
248935|NCT00294320|"~     The purpose of this study is to evaluate the performance of two techniques to monitor the~     clearance of AK lesions when treated with Aldara 5% cream.~   "
248936|NCT00294307|"~     Aim 1. To compare across three hospital sites the effects on health and cost outcomes~     observed by the following three interventions, each designed to enhance adaptation and~     improve outcomes of hospitalized cognitively impaired elders and their caregivers:~        1. augmented standard care (ASC) - standard hospital and, if referred, home care plus early~          identification of CI during the patients' hospitalization by trained registered nurses~          (RNs) with immediate feedback to patients' primary nurses, attending physicians and~          discharge planners;~        2. resource nurse care (RNC) - standard hospital and, if referred, home care plus early~          identification of CI during the patient's hospitalization by trained RNs and hospital~          care by RNs trained in the use of expert clinical guidelines developed to enhance the~          care management of hospitalized cognitively impaired elders and to facilitate their~          transition from hospital to home; or,~        3. advanced practice nurse care (APNC) - standard hospital care plus transitional (hospital~          to home) care substituting for standard home care and provided by APNs with advanced~          training in the management of CI patients using an evidence-based protocol designed~          specifically for this patient group and their caregivers.~      [H1] We hypothesize that health and cost outcomes with APNC, a comprehensive intervention~     designed to meet the unique needs of cognitively impaired older adults hospitalized for an~     acute medical or surgical event and their caregivers will be associated, relative to health~     and cost outcomes with ASC and RNC, with improvement in patient, caregiver and cost outcomes.~      [H2] We hypothesize that improvements in patient, caregiver and cost outcomes observed for~     the RNC group will be greater than those observed for the ASC group.~      Aim 2. To compare within each site and over time, health and cost outcomes (identified in Aim~     1) from patients treated with either ASC or RNC, both relatively lower intensity~     interventions, with the outcomes of patients at the same site observed after switching to~     APNC, a high intensity intervention.~      [H3] We hypothesize that compared to patients receiving the ASC or the RNC interventions,~     patients at the same site will have improved patient, caregiver and cost outcomes after the~     site switches to APNC.~      [H4] We hypothesize that patient, caregiver and cost outcomes achieved by the groups~     receiving APNC interventions at T1 and T2 will be similar.~   "
248937|NCT00294294|"~     The purpose of the study is to determine whether prophylactic antipyretic treatment after~     vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the~     rate of febrile reactions.~   "
248938|NCT00294281|"~     Fibromyalgia syndrome (FMS) is a long-term disorder that is characterized by widespread body~     pain and tender points in joints, muscles, tendons, and other soft tissues. Other symptoms~     associated with the disorder include fatigue and depression. The cause of FMS is unknown, and~     conventional treatments are often unsuccessful in adequately relieving pain. For people with~     severe, unrelenting pain, which is referred to as refractory FMS, opioid maintenance therapy~     may be an option, but it comes with the dangerous potential of addiction and is therefore~     avoided if possible. Vagus nerve stimulation (VNS), in which a nerve located in the neck~     receives electrical input, may be an option for providing pain relief. The purpose of this~     study is to determine the safety, tolerability, and effectiveness of VNS as a treatment for~     people with refractory FMS.~   "
248939|NCT00294268|"~     The purpose of this study is to evaluate the effectiveness of a cognitive behavioural~     treatment (CBT) designed to help obese patients lose weight and to maintain their weight~     losses over time. It is hypothesized that CBT will result in greater sustained weight loss.~   "
248940|NCT00294255|"~     The study aims to assess the efficacy and tolerability of risperidone added to lithium,~     valproate or lamotrigine in patients experiencing a manic episode with depressive or~     irritable features.~   "
248941|NCT00294242|"~     The purpose of this study is to determine if routine membrane sweeping in uncomplicated term~     pregnancies increases the rate of pre-labor rupture of membranes.~   "
248945|NCT00294190|"~     This proposed phase II trial will investigate weekly topotecan at a higher dose than was used~     in the previous trials in an attempt to achieve improved response rates and disease control~     without added toxicity. To help ameliorate the fatigue, planned rest weeks will be~     incorporated into the schedule. This trial will be the first clinical trial to evaluate a~     higher dose of weekly topotecan in the treatment of extensive-stage SCLC.~   "
248946|NCT00294177|"~     Gestational trophoblastic disease comprises a spectrum of diseases with different propensity~     for local invasion and metastasis, that is, partial and complete hydatidiform mole,~     choriocarcinoma, and placental site trophoblastic tumor.All trophoblastic tumors produce hCG,~     and monitoring of therapy is largely based on the determination of hCG in serum. The~     conformational change of tumor markers during antineoplastic chemotherapy for cancer and its~     clinical meaning has only been rarely studied. In this study, we will try to understand the~     conformational change of the tumor marker (hCG) during chemotherapy.~   "
248947|NCT00294164|"~     This study is a Phase 2/3, multicenter, double-blind, randomized, parallel-group,~     placebo-controlled, dose-finding trial of Serostim® (mammalian cell-derived recombinant human~     growth hormone, r-hGH) versus placebo in subjects with human immunodeficiency~     virus-associated adipose tissue redistribution syndrome (HARS).~      The primary study objective is to determine whether Serostim® treatment reduces adipose~     tissue maldistribution more effectively than placebo. The primary co-endpoints are derived~     from measures of visceral adipose tissue assessed by computerized tomography (CT) and the~     ratio of trunk; and limb fat assessed by dual-energy X-Ray absorptiometry (DXA) scans.~     Anthropometric measures, physical exams, quality of life assessments, serial photographs, and~     various laboratory measures will be used to address secondary objectives. These secondary~     objectives relate to the impact of Serostim® on Physician and subject assessments of change~     in body shape, health-related quality of life, attitude towards medication compliance,~     metabolic markers, fat redistribution, and safety.~      On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive daily Serostim®,~     Serostim® and placebo given on alternate days, or daily placebo. Serostim® doses will be~     based on body weight, with a maximum dose of 4 milligram (mg).~      Therapy will continue for 12 weeks. Treatment will then be altered and the new treatment will~     be continued through Week 24. Interim Study Visits will be required at Weeks 2 and 4~     (Treatment Period 1) and at Weeks 14 and 16 (Treatment Period 2). Subjects will be offered to~     be enrolled into a maintenance Protocol (Study 23056) at Week 24.~   "
248948|NCT00294151|"~     The study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of~     spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. The~     investigators hypothesize that, by combining vertebral augmentation with cement and~     radiotherapy, they could achieve an enhancement in pain relief and level of activities, as~     well as a decrease in the side effects of multiple medications used for pain control.~   "
248949|NCT00294125|"~     Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed to treat arthritis. The~     purpose of this study is to test the effectiveness of flavocoxid, a plant-derived compound,~     for the treatment of knee osteoarthritis (OA) in adults.~      Study hypotheses: 1) Flavocoxid has an acceptable safety and tolerability profile as~     determined by the Generally Regarded as Safe (GRAS) profile in patients with OA compared to~     identical placebo. 2) Flavocoxid will be more effective as a therapy for OA compared to~     identical placebo.~   "
248950|NCT00294112|"~     Human mesenchymal stem cells (MSCs), derived from healthy adult volunteer human donors, can~     be obtained from bone marrow donation and cultured in the laboratory. MSCs have shown the~     ability to find injured tissue, reduce and control inflammation, and assist in tissue repair.~      Prochymal™ MSCs will be infused into patients with moderate-to-severe Crohn's disease.~     Infusions will occur on two separate days, 7-10 days apart. Patients will be monitored for~     reduced Crohn's disease symptoms.~   "
248951|NCT00294099|"~     The purpose of this study is to compare how the body reacts to different strengths of the new~     A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide~     dosing information. How the body's immune system responds to the new H5N1vaccine with~     aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be~     evaluated. The vaccine is given as an injection or shot in the arm. Volunteer participants in~     this study will be 600 healthy elderly adults, aged 65 years and older. Participants will be~     randomly assigned to 4 different dosage groups of vaccine, either with or without adjuvant,~     for a total of 8 different groups. Volunteers will participate in the study for 7 months.~     Each individual will receive two vaccinations, the second 28 days after the first. In~     addition to visits for these vaccinations, subjects will return to the clinic for physical~     evaluations and blood sample collection 6 times during the course of this study.~   "
248952|NCT00294086|"~     This study will evaluate the tolerability and safety of valsartan in patients with stable,~     chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week~     (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD~     and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg.~     Patients remain on their prior CHF standard care therapy throughout the study period, and the~     up-titration of valsartan is based on patient tolerability.~   "
248953|NCT00294073|"~     The study aims to compare standard techniques used to control pain after knee surgery. The~     investigators hypothesize that the fascia iliaca block is faster, safer and as good as or~     better than the femoral block, with or without a stimulating catheter.~   "
248954|NCT00294060|"~     The P3 Study is a United States post market study to gather data on clinical status, primary~     indications, device therapy choices, clinical management and outcomes for patients with~     implantable pacemakers.~   "
248955|NCT00294047|"~     This is a multicentre study in which women were planned to receive either the Human~     Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study~     participation will last approximately 48 months and involves a total of eleven scheduled~     visits. Under Protocol Amendment 4, study participation will last up to 84 months and~     involves a maximum of seventeen scheduled visits.~   "
248956|NCT00294034|"~     The purpose of this study is to collect data from pacemakers and determine how this~     information is used by physicians to care for their patients with pacemakers.~   "
248977|NCT00293761|"~     The purpose of the study is to determine whether a glaucoma therapy is safe and effective in~     treating patients with open-angle glaucoma or ocular hypertension~   "
248957|NCT00294021|"~     Pneumococcus is a major cause of morbidity and mortality. In 2000, a pneumococcal conjugate~     vaccine (PCV) was licensed for use in children and is now part of the routine childhood~     vaccine schedule. PCV is known to reduce invasive disease and protect against nasopharyngeal~     (NP) acquisition of vaccine serotype pneumococci; it also results in an increased risk of~     nonvaccine serotype carriage. This study proposes to assess the longterm impact of vaccine on~     NP carriage in a setting where there is intense antibody pressure on the ecology of the~     pneumococcus. A cross sectional study of pneumococcal NP colonization among American Indian~     children will be combined with surveillance for invasive disease in the same population. The~     purpose is to determine the impact of community wide PCV use on NP colonization and the~     relationship with invasive disease. This longterm safety issue needs to be assessed to fully~     evaluate the impact of vaccine on NP ecology and invasive disease.~   "
248958|NCT00294008|"~     This study is a non-interventional web based registry designed to assess demographic,~     treatment and outcomes data in patients receiving treatment with long-acting injectable~     risperidone. One year retrospective data and 2 year prospective data will be collected.~   "
248959|NCT00293995|"~     Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of~     contralateral patent processus vaginalis if present, versus open repair~   "
248960|NCT00293982|"~     The purpose of this study is to determine whether physician knowledge of parental pre-visit~     expectations improves patient satisfaction in the pediatric emergency department.~   "
248961|NCT00293969|"~     RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to~     administer intravenous opiates, what is the difference in pain relief at 60 minutes in~     patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or~     weight-based IV morphine 0.15 mg/kg?~      HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients~     will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.~      SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients~     with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may~     be able to provide evidence to suggest that the higher dose should be used for adult ED~     patients under the age of 66 presenting with acute pain.~   "
248962|NCT00293956|"~     This study was designed to evaluate the level of certain hormones (thyroid hormones and~     cortisol) in full term or close to full term infants who have respiratory distress severe~     enough to require respiratory support. The purpose of this study is to determine if there is~     a relationship between these hormone levels and how sick these infants are who require help~     with breathing following birth.~      Hypothesis: Infants who are born full term or near full term and who have low hormone levels~     will have higher severity of illness.~   "
248963|NCT00293943|"~     The purpose of this study is to investigate the significance of complete versus incomplete~     electrical isolation of pulmonary veins by radiofrequency-induced linear lesions in patients~     with paroxysmal atrial fibrillation.~      The study hypothesis ist that the complete linear PV isolation ablation is superior to the~     non-complete linear PV isolation on the outcome of patients with idiopathic drug-refractory~     atrial fibrillation. As a second hypothesis in this adaptive study design, the~     non-inferiority of the complete linear PV isolation strategy will be tested.~   "
248964|NCT00293930|"~     A study to assess the safety and effectiveness of tacrolimus cream in the treatment of~     psoriasis~   "
248965|NCT00293917|"~     A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis~   "
248966|NCT00293904|"~     The purpose of this study is to evaluate whether the use of a specific immunomodulatory~     principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and~     more pronounced decrease of sensitivity against pollen than with the grass pollen allergen~     alone~   "
248967|NCT00293891|"~     A study to assess the safety and effectiveness of tacrolimus cream in the treatment of~     psoriasis.~   "
248968|NCT00293878|"~     The purpose of this study is to evaluate the safety and effects on lipids of FM-VP4~     administered for 12 weeks in subjects with mild to moderate primary hypercholesterolemia.~   "
248969|NCT00293865|"~     The purpose of this study is to assess the detection rate and false negative rate of sentinel~     lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.~   "
248970|NCT00293852|"~     Heart failure is a condition where the heart does not pump enough blood to the rest of the~     body. People with heart failure may have another condition called the metabolic syndrome(~     having excess fat in the belly, high blood pressure, high fat in the blood, low level of good~     cholesterol and high blood sugar). People who have both heart failure and the metabolic~     syndrome often see many doctors. A new clinic has been formed at Ben Taub General Hospital~     that includes a specialist in heart failure (cardiologist) and in the metabolic syndrome~     (endocrinologist) as well as patient teaching. The goal of this study is to randomize~     patients with the metabolic syndrome who are admitted to the hospital for heart failure to~     this clinic (collaborative care) versus the usual doctor appointments (usual care). The~     purpose of this study is to see if collaborative care is better medical care than usual care.~     Specifically, we will see if patients in collaborative care will have:~        1. fewer admissions to hospitals for illness~        2. better blood pressure, sugar, fat and heart failure control~        3. better patient satisfaction and knowledge about their diseases~        4. lower levels of inflammation.~   "
248971|NCT00293839|"~     The purpose of this study is to compare the efficacy of DITROPANÂ® XL (oxybutynin chloride)~     Extended-Release Tablets and DETROLÂ® LA (tolterodine tartrate extended-release capsules) in~     the reduction of urge urinary incontinence episodes during a 12-week treatment period in~     patients with overactive bladder. The secondary objective is to compare the tolerability of~     DITROPANÂ® XL (oxybutynin chloride) and DETROLÂ® LA (tolterodine tartrate) during a 12-week~     treatment period.~   "
248972|NCT00293826|"~     The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe~     and effective in the treatment of rheumatoid arthritis.~   "
248973|NCT00293813|"~     This study is structured to estimate the effect of denosumab, compared to placebo and~     alendronate, on several bone parameters.~   "
248974|NCT00293800|"~     The purpose of the study is to evaluate the safety and effectiveness of an investigational~     glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.~   "
248978|NCT00293748|"~     This study will determine if the drug Atorvastatin (Lipitor) changes the genetic material~     found in blood cells of people with vascular (blood vessel) disease. Vascular diseases affect~     the blood flow in the body and can lead to a heart attack or stroke. Information gained from~     this study could be used to develop a more reliable blood test that predicts the risk of~     heart attack or stroke.~      People 21 and older who have two or more risk factors for developing vascular disease are~     eligible for this study. Candidates are screened with a medical history, physical~     examination, electrocardiogram, ultrasound of the carotid (neck) arteries, blood tests, and~     check of blood pressure and heart rate.~      Participants are randomly assigned to one of four treatment groups. Three groups receive~     Lipitor in a dose of either 10, 20 or 40 milligrams; the fourth group receives a placebo. All~     take the study drug for 3 months. In addition, they undergo the following tests and~     procedures:~      Study Phase I (Months 2-4)~      Participants in all groups are seen once a month at the NIH Clinical Center for blood tests~     and monitoring of drug side effects.~      Study Phase 2 (Months 5-10)~        -  Placebo group: Participants are given 40 mg of Lipitor for 3 months (months 5-7) and~          seen by a physician once a month during that time. Blood is drawn at the 7-month visit~          and then participants are referred back to their physicians. During months 8, 9 and 10,~          participants are called once a month to check on their health. Participation ends after~          the tenth month.~        -  Lipitor group: Participants are referred back to their physicians for months 5 and 6 and~          are called once a month. During month 7, they return to the clinic for a follow-up~          evaluation and blood test. Participation ends after the seventh month.~   "
248979|NCT00293735|"~     Eclampsia is a major cause of perinatal morbidity and mortality. The pathophysiology is not~     known but magnetic resonance imaging (MRI) and Doppler data suggest that overperfusion of the~     cerebral tissues is a major etiologic factor. Hypertensive encephalopathy from overperfusion,~     and vascular damage from excessive arterial pressure (cerebral barotrauma) are believed to~     lead to vasogenic and cytotoxic cerebral edema, with resultant neuronal anomalies, seizure~     activity and cerebral bleeding if left unchecked. Doppler data have shown that cerebral~     perfusion pressure (CPP) is abnormally increased in severe preeclampsia and that~     autoregulation of the middle cerebral artery is affected by this condition leading to~     increased CPP. Magnesium sulfate (MgSO4) is the most widely accepted eclampsia treatment and~     prophylactic agent, and it has been used in the USA since the 1950's. Despite widespread use,~     its mechanism of action is unknown. MgSO4 is given intravenously or intramuscularly and~     requires specialized nursing training and monitoring to minimize toxicity from respiratory~     and cardiac depression. Labetalol, a combined alpha and beta blocker, has been used for many~     years to safely treat hypertension in preeclamptic women, and is now known to reduce CPP in~     women with preeclampsia. In the United Kingdom labetalol was for many years used as the sole~     agent in treating preeclampsia, and the rate of seizure was no different to that reported in~     the USA with MgSO4. Since labetalol can be administered orally, is economical, has low~     toxicity potential, does not require specialized training to administer or monitor, and~     decreases CPP, it may be an ideal agent for controlling blood pressure (BP) and decreasing~     the incidence of eclampsia in women with preeclampsia. The current study is a multicenter,~     randomized, controlled trial to compare the anti-seizure effect of parenteral MgSO4 versus~     oral labetalol in hypertensive pregnant women who are eligible for MgSO4 therapy. The primary~     outcome measure is eclampsia, and the secondary outcome measures include blood pressure~     control, and relevant antenatal, intrapartum, and postnatal maternal and fetal/neonatal~     parameters including adverse effects and complications. Inclusion criteria are deliberately~     broad in order to make the study clinically relevant. Hypertensive pregnant women, in whom~     the decision for delivery has been made, will be enrolled after written, informed consent.~     Patients will be randomized to receive MgSO4 therapy as given in their institution, versus~     oral labetalol (200mg/q6 hours), from enrollment in the study until 24 hours post delivery.~     There will be 4000 patients in each arm of the study and analysis will be by~     intention-to-treat. The study is powered to show both therapeutic superiority as well as~     clinical equivalence. This study has the potential to change the way preeclampsia is managed,~     and will represent a major advance in terms of the availability and safety of prophylactic~     therapy, especially in developing nations where MgSO4 is underutilized due to cost~     constraints.~   "
248980|NCT00293722|"~     The purpose of this study is to evaluate the safety and effectiveness of etanercept under~     usual care settings in patients with PsA treated by rheumatologists.~   "
248981|NCT00293709|"~     The purpose of this study is to evaluate the safety profile and the effectiveness of~     etanercept under usual care settings in patients with PsA treated by dermatologists.~   "
248982|NCT00293696|"~     To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate~     comparison to chemical castration induced (goserelin) ones~   "
248983|NCT00293683|"~     We hypothesize that the use of absorbable staples to close cesarean skin incisions will cause~     less pain, have better long-term cosmetic results, and result in improved patient~     satisfaction over standard metal staples. We expect to see no difference in wound~     complication rates with these two cesarean skin closure techniques.~   "
248984|NCT00293670|"~     To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen~     deprivation (LHRHa treatment or orchidectomy)~   "
248985|NCT00293657|"~     To determine whether a single dose of intravenous lornoxicam is superior to intravenous~     placebo for the acute treatment of moderate or severe headache associated with a single~     migraine attack in patients with a history of migraine. Two-thirds of patients in this study~     will receive a single dose of intravenous lornoxicam (8mg or 16 mg) and one-third of patients~     will receive a single dose of an intravenous placebo.~   "
248986|NCT00293644|"~     The purpose of this study is to determine whether pre-emptive use of a delayed release~     combination of pyridoxine hydrochloride and doxylamine succinate (Diclectin®), before~     eruption of symptoms of Nausea and vomiting of pregnancy and hyperemesis gravidarum, will~     reduce the incidence of severe forms of this syndrome/HG.~   "
248987|NCT00293631|"~     To determine whether a single dose of intravenous lornoxicam is superior to intravenous~     placebo for management of post-operative pain in patients who have surgical removal of a~     bunion on the lower extremity. One-fourth of patients in this study will receive a single~     dose of intravenous ketorolac for management of pain and one-fourth of patients in this study~     will receive a single dose of an intravenous placebo.~   "
248988|NCT00293618|"~     This study evaluates whether the implementation of a prediction rule for postoperative nausea~     and vomiting changes physician behaviour, improves patient outcome and improves~     cost-effectiveness of treatment of postoperative nausea and vomiting.~   "
248989|NCT00293605|"~     Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips,~     the aims of this study are to determine the effect of implant stem design on bone quality~     surrounding the implant using three stem designs that are routinely implanted at this~     hospital.~   "
248990|NCT00293592|"~     This is a multicenter, randomized, double-blind trial, comparing clinical outcomes after the~     administration of high-dose dexamethasone versus placebo in patients undergoing heart surgery~     with the use of cardiopulmonary bypass. The primary endpoint is the occurrence of major~     complications (including all-cause mortality, myocardial infarction, stroke, renal failure,~     and prolonged mechanical ventilation) in the first 30 days after surgery.~   "
248991|NCT00293579|"~     This study will estimate overall response rate of pemetrexed in poor risk patients with~     advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.~   "
248992|NCT00293553|"~     Total proctocolectomy and ileal pouch-anal anastomosis is the surgical treatment of choice~     for patients with medically refractory ulcerative colitis, ulcerative colitis with dysplasia~     or cancer, and patients with familial adenomatous polyposis. Pouchitis, an inflammatory~     process of the ileal pouch, is the most common long-term complication. Increased stool~     frequency, abdominal pain, and pelvic discomfort are suggestive of pouchitis, approximately~     40% of patients with these symptoms have no or minimal inflammation of the pouch or rectal~     cuff on endoscopy and histopathology. These patients have a condition resembling irritable~     bowel syndrome (IBS), which we termed the irritable pouch syndrome (IPS). The RATIONALE and~     FEASIBILITY for the proposed study are: 1) IPS occurs in a substantial number of patients~     with IPAA, significantly affecting the quality of life. However, IPS is rare in the general~     population, and is considered an orphan disease. Studies such as those we propose can only be~     conducted in centers with a large number of patients with IPAA. The Cleveland Clinic has~     maintained the world's largest ileal pouch registry, with a total of more the 2,500 patients;~     2) a series of investigations on the diagnosis and treatment of patients with inflammatory or~     functional diseases of IPS, notably the initial study of IPS, have been conducted by our~     team; 3) In contrast to IBS, the pathophysiology and treatment of IPS have not been studied.~     Our HYPOTHESES are that 1) similar to IBS, visceral hypersensitivity may play a role in the~     pathogenesis of IPS, and 2) amitriptyline, a safe and effective agent for patients with IBS,~     will be more effective than placebo in alleviating symptoms and improving quality of life in~     patients with IPS. The AIMS of the study are to 1) investigate visceral hypersensitivity~     using barostat examination of the pouch; 2) conduct a randomized, placebo-controlled clinical~     trial evaluating the use of amitriptyline in IPS.~   "
248993|NCT00293540|"~     This study will determine if hormone receptor positive premenopausal metastatic breast cancer~     patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a~     longer survival.~   "
248998|NCT00293475|"~     This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and~     carboplatin and to see how well they work in treating patients with primary central nervous~     system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier~     disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing~     substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may~     block cancer growth in different ways by targeting certain cells. Giving methotrexate,~     mannitol, rituximab, and carboplatin together may be an effective treatment for primary~     central nervous system lymphoma.~   "
248999|NCT00293462|"~     RATIONALE: GM-CSF may protect normal cells from the side effects, such as mucositis, of~     radiation therapy and may help damaged tissue heal faster after radiation therapy.~      PURPOSE: This randomized clinical trial is studying how well GM-CSF works in preventing and~     treating mucositis in patients who are undergoing radiation therapy for head and neck cancer.~   "
249000|NCT00293436|"~     RATIONALE: Celecoxib and erlotinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for their growth. Celecoxib may also stop the growth of liver cancer by~     blocking blood flow to the tumor.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving celecoxib~     together with erlotinib and to see how well they work in treating patients with liver cancer.~   "
249001|NCT00293423|"~     RATIONALE: Vaccines made from a person's tumor cells, such as gp96 heat shock protein-peptide~     complex, may help the body build an effective immune response to kill tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of gp96 heat shock~     protein-peptide complex vaccine and to see how well it works in treating patients with~     recurrent or progressive high-grade glioma.~   "
249002|NCT00293410|"~     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine and~     cyclophosphamide in treating patients with relapsed or refractory acute leukemia, chronic~     myelogenous leukemia, or myeloproliferative disorders.~   "
249003|NCT00293397|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or stopping them from dividing.~     Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping~     chemotherapy drugs near the tumor.~      PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works~     in treating patients with liver cancer that cannot be removed by surgery.~   "
249004|NCT00293384|"~     RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help~     lessen or prevent nausea and vomiting in patients treated with chemotherapy.~      PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron~     and dexamethasone works in preventing nausea and vomiting in patients receiving~     cyclophosphamide before undergoing an autologous stem cell transplant.~   "
249005|NCT00293371|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. Giving vatalanib together with~     docetaxel and prednisone may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of vatalanib when~     given together with docetaxel and prednisone and to see how well they work in treating~     patients with advanced prostate cancer.~   "
249006|NCT00293358|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, ifosfamide, and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may~     kill more tumor cells.~      PURPOSE: This phase III trial is studying combination chemotherapy followed by radiation~     therapy to see how well it works compared to radiation therapy alone in treating patients~     with germ cell tumors in the brain.~   "
249007|NCT00293345|"~     This phase I trial is studying the best dose of 3-AP and the side effects of giving 3-AP~     together with gemcitabine in treating patients with advanced solid tumors or lymphoma. Drugs~     used in chemotherapy, such as 3-AP and gemcitabine (GEM), work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. 3-AP~     may help gemcitabine kill more cancer cells by making the cells more sensitive to the drug.~     3-AP may also stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
249008|NCT00293332|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Giving docetaxel and carboplatin~     together with bevacizumab before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together~     with bevacizumab works in treating patients with stage I, stage II, or stage III non-small~     cell lung cancer that can be removed by surgery.~   "
249009|NCT00293319|"~     RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells~     and not harm normal cells.~      PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with~     refractory or relapsed neuroblastoma.~   "
249075|NCT00292344|"~     Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to~     antibiotic treatment.The study was designed to determine the value of rapidly acting~     loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in~     travelers' diarreha treatment.~   "
249010|NCT00293293|"~     RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who~     are undergoing chemotherapy.~      PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy~     and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed~     epithelial ovarian, fallopian tube or peritoneal cavity cancer.~   "
249011|NCT00293280|"~     RATIONALE: Drugs used in chemotherapy, such as lomustine, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well lomustine works in treating patients with~     stage III or stage IV non-small cell lung cancer.~   "
249012|NCT00293267|"~     This study will investigate the safety and efficacy of raltegravir as a therapy for~     HIV-infected patients failing current therapy with 3-class antiviral resistance.~   "
249013|NCT00293254|"~     This study will investigate the safety and efficacy of raltegravir as a therapy for Human~     Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral~     resistance.~   "
249014|NCT00293241|"~     The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable~     cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.~   "
249015|NCT00293228|"~     The purpose of this study is to study the effect that treatment of dormant tuberculosis~     infection has on the immunological system.~      We expect to observe an impact over the production of cytokines by peripheral white blood~     cells which may be useful to know if treatment has been effective.~   "
249016|NCT00293215|"~     This is a clinical trial of a drug called CMD-193 which is a humanised monoclonal antibody~     linked to a toxin (calicheamicin). The purpose of this study is to determine in patients with~     advanced tumours expressing the Lewis-Y antigen:~        -  How much and how long 111-In-CMD-193 (CMD-193 tagged with a small amount of radioactive~          Indium – also called Indium-111 or 111In) circulates in the blood, where the antibody~          goes in the body, and how much attaches to the tumour.~        -  Whether CMD-193 causes changes in the metabolism (activity) of the tumour.~        -  Whether CMD-193 causes shrinkage of the tumour.~   "
249017|NCT00293202|"~     Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid~     arthritis. We are examining whether etanercept is effective in improving the nutritional~     status of hemodialysis patients as a consequence of its ability to decrease inflammation.~     Hemodialysis patients with end stage renal disease have a high mortality rate. In individual~     patients, mortality is associated with a low serum albumin concentration, a marker of poor~     nutritional status, and with elevated C-reactive protein, a marker of inflammation. Since~     efforts to improve nutrition through dietary intake have not been successful, inflammation is~     thought to play a key role in determining nutritional status. Recently, it has been shown~     that malnutrition, inflammation, and atherosclerosis are closely related in patients with~     chronic renal failure. It is our hypothesis that suppression of the cycle of inflammation,~     malnutrition, and vascular injury caused by atherosclerosis will improve survival in dialysis~     patients. This study is designed to examine whether suppression of the inflammatory response~     can be accomplished safely with etanercept and to determine if this suppression will improve~     nutritional status and clinical outcome in hemodialysis patients with poor nutritional status~     and evidence of inflammation.~   "
249018|NCT00293189|"~     We are looking after gene-polymorphies in the p2x7-gene in patient with osteoporotic~     fractures.~   "
249019|NCT00293176|"~     To investigate the efficacy and safety of donepezil in individuals with mild cognitive~     impairment on measures of cognition, global function and behavior.~   "
249020|NCT00293163|"~     To assess the likelihood of keloid and scar formation, pigmentation disorders and~     hypersensitivity reactions in patients with skin of color undergoing correction of facial~     soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.~   "
249021|NCT00293150|"~     The principle aim is to determine the efficacy of eplerenone in patients with diastolic heart~     failure to reverse cardiac remodeling and to improve diastolic function.~   "
249022|NCT00293137|"~     The principal aim is to investigate the safety and efficacy of rosiglitazone in patients with~     chronic systolic heart (Dilated cardiomyopathy). We hypothesize that in patients with heart~     failure, rosiglitazone is safe, and can reduce nitric oxide (NO) derived oxidative stress (in~     particular, nitrotyrosine) thereby improving endothelial dysfunction, left ventricular~     performance, and metabolic parameters.~   "
249023|NCT00293124|"~     The rationale is to assess the clinical and biological activity of Imatinib and to compare~     the data with historic data.~      Additionally this study has been designed to gain more experience with the treatment of GIST~     in several Central and Eastern European Countries.~   "
249024|NCT00293111|"~     An Open Label, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101~     (R-Etodolac) in Patients with Relapsed or Refractory Multiple Myeloma (MM)~   "
249025|NCT00293098|"~     Patients who have iron overload due to chronic blood transfusions and have developed heart~     failure or who are at high risk of heart failure because of the high levels of iron in their~     hearts, will be treated with deferiprone, an investigational drug, in combination with~     deferoxamine (Desferal). Some studies suggest that deferiprone may be better than~     deferoxamine in removing iron from the heart and improving heart function, and that using~     both drugs together may remove more iron. Participants would make a clinic visit for lab~     studies each week, and would continue to take deferiprone for as long as their physician~     feels it is useful in their care.~   "
249026|NCT00293085|"~     The objective of this study is to evaluate efficacy, safety and quality of life adjuvant~     docetaxel-cisplatin chemotherapy versus no adjuvant treatment in patients with completely~     resected NSCLC Stage I-II.~   "
249038|NCT00292916|"~     The effect of whole body vibration (WBV) on bone strength and fall frequency in older adults~     is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in~     very frail elderly, there is a lack of data concerning the effect of WBV in community-living~     elderly woman. We hypothesize that WBV significantly affects bone parameters as assessed by~     DXA, QCT, US and bone markers with parallel positive changes of fall related risk factors~     (power, strength, balance, and reaction time). We further hypothesize that the effects of WBV~     were superior to conventional resistance exercise.~   "
249027|NCT00293072|"~     Lupus and vasculitis are autoimmune conditions which can be life threatening. In order to~     treat these conditions toxic therapies such as cyclophosphamide and steroids are often~     required. These standard treatments are associated with significant side effects. Furthermore~     a proportion of patient do not respond to these conventional therapies. Newer safer therapies~     are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one~     part of the human immune system that helps prevent infections. Abnormal activity of the~     immune system is responsible for autoimmune disease although the exact mechanisms in lupus~     and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B~     cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this~     context. It has recently been used to treat some autoimmune conditions with positive results.~     In this pilot study we wish to assess the effectiveness and safety of rituximab in patients~     with lupus and vascultis that are resistant to conventional therpies.~   "
249028|NCT00293059|"~     The purpose of this study is to determine whether the study drug is safe and effective in the~     treatment of dysfunctional uterine bleeding.~   "
249029|NCT00293046|"~     This trial is performed to assess whether the Grazax® treatment compliance can be improved by~     use of a compliance device (Memozax®).~   "
249030|NCT00293033|"~     The purpose of this study is to evaluate the efficacy of BEMA fentanyl at any dose in the~     management of breakthrough pain in cancer subjects on background opioid therapy. The standard~     of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with~     minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used,~     but because of slow and variable oral absorption, the pain control is not the best with these~     products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating~     breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick~     and is administered by continuously swabbing the interior of the subject's mouth until the~     product is dissolved (approximately 15 to 30 minutes). The buccal route of administration~     avoids the delay and variability associated with oral absorption.~      BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive)~     fentanyl, an alternative product to OTFC that does not require the subject to continuously~     paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is~     placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc~     readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of~     the disc are water soluble, so the entire dosage form dissolves within 30 minutes of~     application.~   "
249031|NCT00293020|"~     The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the~     management of breakthrough pain in cancer subjects on background opioid therapy. The standard~     of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with~     minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used,~     but because of slow and variable oral absorption, the pain control is not the best with these~     products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating~     breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick~     and is administered by continuously swabbing the interior of the subject's mouth until the~     product is dissolved (approximately 15 to 30 minutes). The buccal route of administration~     avoids the delay and variability associated with oral absorption.~      BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive)~     fentanyl, an alternative product to OTFC that does not require the subject to continuously~     paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is~     placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc~     readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of~     the disc are water soluble, so the entire dosage form dissolves within 30 minutes of~     application.~   "
249032|NCT00292994|"~     The Metabolic Syndrome (MS) is prevalent in the American population and is strongly~     associated with premature coronary disease. Lifestyle intervention, primarily exercise and~     dietary changes, are foundational treatment strategies for independent components of MS, but~     these interventions have not been thoroughly evaluated in MS. Even with very modest weight~     loss, in the setting of caloric restriction and exercise, marked improvement MS parameters~     have been noted. However, it is not known whether it is diet with weight loss or exercise~     that improves the metabolic derangements associated with MS. We propose a study designed to~     examine the relative impact of diet or exercise on the components of MS. Furthermore, it is~     known that psychological factors significantly impact the ability of patients to initiate and~     sustain lifestyle changes. We will monitor certain psychological states to evaluate their~     impact on the success of weight loss and sustainability of lifestyle changes throughout this~     study. Specific Aims: 1.) Evaluate the relative efficacy of diet with weight loss or exercise~     on improving the markers of metabolic syndrome. 2.) Determine of pre-existing psychological~     factors influence the effectiveness of diet with weight loss or exercise on the markers of~     metabolic syndrome. Design: Adult women (> 18 yrs) with a body-mass index (BMI)  30 kg/m2~     will be assessed for MS and randomized to one of three groups (n = 34/group), Control (C),~     diet with weight loss alone (D), or exercise alone (E). The intervention groups will~     participate in supervised dietary changes designed for weight loss or exercise for 6 months.~     Anthropomorphic, serologic, and psychological parameters will be monitored and compared using~     ANOVA. Hypothesis: As indexed by the improvement in the laboratory markers of the components~     of metabolic syndrome, exercise alone has a more profound positive impact on Metabolic~     Syndrome then diet with weight loss alone.~   "
249033|NCT00292981|"~     Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional~     C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be~     life-threatening and may even result in fatalities, especially in case of involvement of the~     larynx.The planned extension study is designed to enrol subjects that participated in the~     pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24~     months or until the licensing procedure for C1-INH is finalized, whatever comes first.~   "
249034|NCT00292968|"~     Using an electronic health record to link the resources of primary care practices and~     community programs will help patients to improve their diet and exercise, quit smoking, and~     moderate their drinking.~   "
249035|NCT00292955|"~     The anti-tumor activity of cetuximab prior to chemoradiotherapy and the safety and~     tolerability of cetuximab with concurrent chemoradiation will be determined in women with~     locally advanced or metastatic cervical carcinoma.~   "
249036|NCT00292942|"~     The purpose of this study is to establish the safety, tolerability, and pharmacokinetics of a~     multiple dose of the antimalarial drug artesunate.~   "
249037|NCT00292929|"~     The purpose of this study is to establish the safety, tolerability and pharmacokinetics of a~     single dose of the antimalarial drug artesunate.~   "
249039|NCT00292903|"~     This study will compare the effectiveness of brief interpersonal psychotherapy versus~     standard treatment for pregnant women with depression.~   "
249040|NCT00292890|"~     Background and aims:~        -  In the Netherlands most patients with diabetes mellitus that are treated with insulin,~          use an insulin pen for insulin administration. The injection technique can influence the~          absorption rate of insulin.~        -  The aim of this study is to compare the effect of insulin injections using a 5 mm~          insulin needle with insulin injections using a longer needle, on HbA1c, bloodglucose~          levels, hypoglycaemic events, bleeding, bruising, insulin leakage and pain perception.~        -  Study Hypothesis: 'Insulin injected with needles of 5 mm can be given without a~          skinfold. The length of the needle will not influence HbA1c levels and bloodglucose~          levels’.~   "
249041|NCT00292877|"~     The purpose of this study is to determine if treatment with anti-IL-5 antibody has a~     prednisone-sparing effect in patients with symptomatic eosinophilic bronchitis (with or~     without asthma).~   "
249042|NCT00292864|"~     The purpose of this study is to assess the safety and tolerability of one-hour infusions~     given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended~     phase 2 dose; and to learn more about the clinical activity of SNS-032.~   "
249043|NCT00292851|"~     To process blown nasal secretions from subjects with rhinosinusitis and to obtain a specimen~     by nasal lavage. To investigate the reliability and validity of the measurements we will~     determine their repeatability and compare them with those of nasal lavage in the same~     subjects.~   "
249044|NCT00292838|"~     To investigate the validity of a clinical model to determine the relative potency of~     different preparations of inhaled corticosteroids used for the treatment of asthma or of~     eosinophilic bronchitis without asthma.~   "
249045|NCT00292825|"~     The main purpose is to prevent syncope in patients with recurrent syncopal episodes caused by~     malignant vasovagal faints and bradycardia. Patients are treated by a special pacemaker~     (closed loop stimulation [CLS]) which can potentially identify an incipient attack and~     prevent syncope by pacing.~   "
249046|NCT00292812|"~     The study hypothesis is that different concentrations of nucleotides' supplementation of an~     infant formula might affect differently growth and/or other clinical parameters in neonates.~   "
249047|NCT00292799|"~     This study aims to investigate the role of the weight reduction agent, Orlistat compared to~     the Metformin for the management of women who are obese and do not ovulate or have difficulty~     conceiving. Patients will receive either one of these medications and will be monitored at~     regular intervals with hormone blood tests and ultrasound scans in order to study the effect~     of the medications on the reproductive functions. Patients will receive the medications for~     three months and the study will end if the patient becomes pregnant. The study also aims to~     investigate the dose of metformin that should be used as there is no consensus to date~     regarding the optimum dosage for this drug~   "
249048|NCT00292786|"~     This proposal is designed to achieve the following specific aims and will test the associated~     hypotheses:~      AIM 1: To compare walking ability, standing posture, gait initiation and functional standing~     and stepping of twenty children with typical development to that of twenty children with~     spastic diplegia or hemiplegia, CP.~      Hypotheses~        -  Children with CP will demonstrate impaired coordination as compared to children of~          typical development. In addition, children with CP will demonstrate inappropriate foot~          contact area, decreased velocity and step length as compared to children of typical~          development.~        -  Children with CP will demonstrate impaired postural control as compared to children of~          typical development.~        -  Children with CP will demonstrate an impaired gait initiation motor program as compared~          to children with typical development.~        -  Children with CP will take more time to complete the timed up and go test and~          demonstrate decreased reaching distances in the functional reach test as compared to~          children of typical development.~      AIM 2: Using a single-blinded, randomized, controlled study design, to assess the ability of~     a 12-week at-home electrical stimulation gait training program to improve walking ability,~     standing posture, gait initiation, functional standing and stepping, and satisfaction with~     walking ability for a group of 10 children with spastic diplegia or hemiplegia CP as compared~     to a group of 10 children with spastic diplegia or hemiplegia CP who undergo a 12-week~     at-home gait training program without electrical stimulation.~      Hypotheses~        -  The ES gait training group will demonstrate improved joint coordination as compared to~          the group undergoing a gait training program without ES. The ES gait training group will~          demonstrate improved foot contact area, increased self-selected walking velocity and~          greater step length as compared to the group undergoing a gait training program without~          ES.~        -  The ES gait training group will demonstrate improved postural control as compared to the~          group undergoing a gait training program without ES.~        -  The ES gait training group will demonstrate improved gait initiation as compared to the~          gait training group without ES.~        -  The ES gait training group will demonstrate decreased times on the Timed Up and Go and~          an increase in functional reach as compared to the group undergoing a gait training~          program without ES.~        -  The ES gait training group will demonstrate greater satisfaction and self-perceived~          performance on everyday tasks related to walking function and posture as measured by the~          COPM compared to the group that undergoes a gait training program without ES.~   "
249049|NCT00292773|"~     This study will investigate the role of weight reduction surgery on the reproductive~     performance of obese women with ovulation problems. It is hypothesized that surgery offered~     when other methods of weight reduction have failed, may help restore ovulation.~   "
249050|NCT00292760|"~     This is a phase II open label study for patients with p53-deleted CLL who require treatment.~     Both untreated and previously treated patients are eligible for study entry.~      The trial consists of giving continuous alemtuzumab and cyclical high-dose~     methyl-prednisone.Alentuzumab is given intravenously during the first 4 weeks of treatment to~     ensure that adequate serum levels are achieved quickly. The drug will be administered daily~     during the first week, commencing at a dose of 3mg, and increasing to 10mg and then up to the~     target dose of 30mg as tolerated.Thereafter alemtuzumab will be given at a dose 30mg thrice~     weekly. From week 5, alemtuzumab will be given at the same dose but by the subcutaneous route~     of administration.~      Methlyprednisolone will be given for 5 consecutive days at a daily dose of 1.0g/m2, starting~     on Day 1 and repeating the cycle every 28 days.~      Treatment will be given for 16 weeks (i.e 4 cycles of methylprednisolone). Treatment will be~     discontinued if there is no response after 8 weeks, or if toxicity becomes unacceptable.~   "
249051|NCT00292747|"~     The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg~     is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered~     alone, in the treatment of primary and secondary dysmenorrhoea.~   "
249052|NCT00292734|"~     Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more~     effective in the treatment of the secondary insomnia of depressive and dysthimic patients~     than antidepressant therapy alone in the acute phase of the disease.~   "
249053|NCT00292721|"~     Several studies including ours have reported that celecoxib improves endothelium-dependent~     vasodilation and reduces inflammation and neointimal hyperplasia. Our hypothesis is that~     celecoxib may reduce the late luminal loss after coronary stent implantation~     (paclitaxel-eluting stent.~   "
249054|NCT00292708|"~     To determine the optimal prophylactic antibiotics administration method in elective~     colorectal surgery~   "
249055|NCT00292695|"~     To determine whether adding combinational chemotherapy concurrently to conventional radiation~     will improve the response rate, event-free survival, and overall survival.~      To test the dose intensity and toxicity of chemotherapy in concurrence with radiation.~      To detect the blood EBV DNA level in Chinese Nasal NK/T-cell lymphoma patients and correlate~     to the treatment response and prognosis.~   "
249072|NCT00292383|"~     The purpose of this study is to determine whether there is a relationship between ventricular~     lead position and the incidence of heart failure and atrial fibrillation in patients with~     indication for permanent pacemaker stimulation.~   "
249056|NCT00292656|"~     Background: It has been suspected in our clinic patients that when patients do not wash their~     hands after receiving NAET treatments, the effect of their treatments has been reduced or in~     some cases, the same treatment has to be repeated more times to be effective.~      Location of the study: PNIB Research Center 6714 Beach Blvd. Buena Park, CA 90621~      Purpose The purpose of the study was to determine the importance of hand-washing with plain~     water after each NAET® treatment. The study utilized an experimental design with random~     assignment to two groups, consisting of treatment/experimental, and treatment/control groups.~      Objective: We sought to determine if there is any benefit to mandate hand-washing with plain~     water after each NAET® treatment.~   "
249057|NCT00292591|"~     The purpose of this study is to determine the effectiveness of vitamin D supplementation~     during pregnancy starting at the beginning of the second trimester. Mothers will be~     randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units~     per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D~     status of women regardless of their ethnicity or race.~   "
249058|NCT00292578|"~     Background: Studies have noted a correlation between food sensitivities and health disorders.~     Various commonly seen health problems may be caused by cane sugar since it is lavishly and~     frequently used by people worldwide.~      Objective: This study evaluated the efficacy of NAET testing instruments in detecting~     hypersensitivities to cane sugar.~      Materials and Methods: Seventy-four subjects volunteered for this study. They were asked to~     write down one of their major health problems, the amount of sugar consumed on a daily basis~     and any known health problem(s) related to sugar consumption. The following testing~     modalities were used in the study: (1). Allergy Symptom-Rating Scale (ASRS); (2). NST Rating~     Scale (NSTRS); (3). Pulse Difference Rating Scale (PDRS). Test-1 was done twice. Tests 2 and~     3 were done three times each: once without contacting sugar and then contacting sugar at one~     minute and ten minutes.~   "
249059|NCT00292552|"~     This is a 3 year longitudinal study to identify novel endpoints and compare these with~     standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to~     measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression~     over time. Control subjects (smokers and never smokers) will be recruited as comparators with~     the COPD subjects.~   "
249060|NCT00292539|"~     This registry is a data collection on patients who are implanted for more than 6 months with~     a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left~     ventricular ejection fraction shall be documented.~   "
249061|NCT00292526|"~     In cancer patients, the increase of troponin I soon after chemotherapy is a strong predictor~     of left ventricular dysfunction and poor cardiologic outcome. This information provides a~     rationale for the development of prophylactic strategies directed against~     chemotherapy-induced cardiotoxicity (CTIC). Activation of the renin-angiotensin system has~     been proved to be involved in the development and progression of cardiac dysfunction in~     several clinical settings, and has been suggested to have a role in the occurrence of CTIC.~     We investigated the role of treatment with ACE-inhibitors in the prevention of CTIC in~     high-risk cancer patients.~   "
249062|NCT00292513|"~     Standard suture is superior to both tissue adhesive (2-octyl cyanoacrylate) and absorbable~     sutures with respect to cosmetic outcome of, complication rate of and parental satisfaction~     with the closure of low tension facial, neck and shoulder, wounds in children and adolescents~   "
249063|NCT00292500|"~     This evaluation is designed to evaluate the feasibility of using an automated distal coronary~     anastomotic to facilitate grafting of the left internal mammary artery to the left anterio~     descending coronary artery during myocardial revascularization in patients with coronary~     artery disease requiring surgical intervention. The study is designed to assess the ability~     to compare the patency of grafts created using an automated device versus hand-sewn grafts of~     the same vessels in the same patient population.~   "
249064|NCT00292487|"~     The purpose of the study is to compare the incidence of contrast induced nephrotoxicity~     following the administration of Isovue or Visipaque in patients with mild to moderate renal~     impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed~     tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine~     (SCr) will be measured before and up to 48-72 hours post dose.~   "
249065|NCT00292474|"~     The ultimate goal of a paclitaxel eluting stent system (TAXUS stent) is to prevent restenosis~     by blunting the initial response to stent implant injury and sustaining the arrested response~     until vascular healing has taken place.~      The purpose of the TAXUS IV-SR trial is to study the safety and efficacy of the TAXUS Stent~     under controlled trial circumstances used in the treatment of new coronary artery lesions~     (heart blockages) This clinical investigation will evaluate the safety and effectiveness of~     the TAXUS Stent with 1 ug/mm2 (loaded drug/stent surface area) of paclitaxel incorporated~     into a slow rate-release formulation of a triblock copolymer carrier system for treatment of~     new coronary artery lesions.~   "
249066|NCT00292461|"~     The purpose of this study is to evaluate the efficacy and safety of zonisamide for~     anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial~     or partial with secondary generalized seizures.~   "
249067|NCT00292448|"~     The objective of this trial is to compare the efficacy and the safety of Ba 679 BR Respimat 5~     ug once daily to tiotropium inhalation capsule 18 ug (Spiriva inhalation capsule) in a~     crossover study of 4-week treatment periods in patients with COPD.~   "
249068|NCT00292435|"~     To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous~     insufficiency linked to edema (swelling) and subjective symptoms~   "
249069|NCT00292422|"~     This Phase 2a study is designed to evaluate the safety and tolerability of multiple~     subcutaneous (SC) doses of BG9924, administered in a cohort dose-escalation fashion, in~     patients with active rheumatoid arthritis (RA) who have had an inadequate response to therapy~     with disease-modifying anti rheumatic drugs (DMARDs) and who may have undergone anti-TNF~     therapy. This study will assist with dose selection for further planned Phase 2 studies.~   "
249070|NCT00292409|"~     The purpose of this clinical research study is to evaluate the overall effectiveness of 8~     week of aripiprazole treatment.~   "
249071|NCT00292396|"~     The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of~     moderate to severe chronic plaque psoriasis.~   "
249076|NCT00292331|"~     The purpose of this study was to test the hypothesis by comparing the efficacy of~     cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute GVH in liver~     cirrhotic patients with or without concomitant hepatocellular carcinoma (HCC).~   "
249077|NCT00292318|"~     The purpose of this study is to determine if a behavioral treatment method called biofeedback~     will reduce the frequency of episodes of leakage of fecal material in patient suffering from~     fecal incontinence.~   "
249078|NCT00292305|"~     This is a study of crush- or culotte stenting of bifurcation lesions using drug eluting~     stents. This is a randomized Nordic multicenter study including 400 patients with angina~     pectoris with clinical angiographic follow-up.~   "
249079|NCT00292292|"~     The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single~     level degenerative disc disease at L4/5 or L5/S1.~   "
249080|NCT00292279|"~     The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil~     emulsion on outcome in post-operative cancer patients.~   "
249081|NCT00292266|"~     This is an open-label, randomized, multicenter, comparative, and parallel-group study~     comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting~     multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44~     microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of~     Avonex® 30 mcg intramuscular injection given once a week.~   "
249082|NCT00292253|"~     This is a randomized, multicenter, parallel-group, open-label study comparing the~     tolerability of Rebif® injections (44 microgram [mcg] administered subcutaneously three times~     a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting~     multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two~     Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a~     minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to~     assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3~     months after the initiation of treatment.~   "
249083|NCT00292240|"~     Over the past decade, many new programs intended to prevent substance use among adolescents~     have been developed and evaluated. There has been a recent shift towards brief interventions~     for youth in school (Brown, 2001; D'Amico and Fromme, 2002) and health care settings, such as~     emergency rooms and inpatient clinics (Barnett et al., 2001; Colby et al., 1998; Monti et~     al., 1999). Although the primary care setting presents a unique opportunity to intervene with~     youth concerning drug use, such as marijuana or inhalants, many youth are not screened for~     use (Friedman et al., 1990; Johnson and Millstein, 2003; Middleman et al., 1995) and~     preventive services in this setting are significantly below recommended levels~     (Halpern-Felsher et al., 2000; Klein et al., 2001; Ozer et al., 2001). The objectives of the~     proposed research are to: 1) explore the feasibility of adapting a brief intervention from~     our previous work for use in the primary care (PC) setting, and 2) assess the short-term~     efficacy of the intervention in the PC setting. During year 1, focus groups of high-risk~     youth (n=16), parents (n=8), and providers (n=8) will provide feedback on barriers to~     implementing a substance use brief intervention in a PC setting. We define high-risk youth as~     those who may have already developed regular patterns of use or have experienced some~     problems due to their use. In addition, the intervention will be pilot tested with 10~     high-risk youth who will provide feedback on intervention content. Revisions will be made to~     the intervention curriculum based on this feedback and in year 2, the short-term efficacy of~     the intervention will be tested with a small sample of high-risk youth (n=30). This study~     will extend brief intervention research for youth, as it will be one of the first to examine~     the feasibility of implementing a brief substance use intervention to PC with high-risk youth~     and to determine the impact of this intervention on short-term outcomes.~   "
249084|NCT00292227|"~     The purpose of this trial is to assess whether rotigotine has an effect on the electrical~     activity of the heart. Moxifloxacin infusion is used as positive control to assess assay~     sensitivity.~   "
249085|NCT00292214|"~     To determine the amount of paracetamol in the blood when given in either intravenous or oral~     forms prior to cholecystectomy. The clinical effectiveness of each form will also be~     evaluated with pain scores and the use of other pain relief drugs.~   "
249086|NCT00292201|"~     Asthma is a chronic respiratory condition characterized by bronchial hyper-responsiveness~     secondary to abnormal inflammation of the lung. Steroids remain the most effective treatment~     for this condition. The lipid lowering agents statins have been found to have~     anti-inflammatory properties. This study is to test the hypothesize that statins will~     decrease bronchial hyperresponsiveness and inflammation, leading to improved symptoms in~     patients with asthma.~   "
249087|NCT00292188|"~     To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic~     peripheral neuropathic pain~   "
249088|NCT00292175|"~     The purpose of the study is to determine whether a new colonoscopic viewing technique called~     narrow band imaging (NBI) helps doctors detect more patients with at leat one pre-cancerous~     area (dysplasia associated lession or mass, MALMs) than conventional colonoscopy using white~     light alone.~   "
249089|NCT00292162|"~     Heart failure is a condition that occurs when the heart muscle weakens and no longer~     contracts normally. Half of these patients have an irregularity of heart rhythm called atrial~     fibrillation (AF). Patients with both heart failure and AF spend more time in hospital, and~     die earlier than those with heart failure alone. AF is difficult to treat with conventional~     methods in patients with heart failure. Radiofrequency ablation is a new technique used to~     cure AF. The investigators aim to establish if radiofrequency ablation for atrial~     fibrillation in patients with advanced heart failure can result in marked improvement in the~     function of the heart.~   "
249090|NCT00292136|"~     Background:~        -  The treatment of addiction often hinges on preventing relapse into drug-using behaviors,~          which occurs at high rates even after prolonged abstinence. Research has shown that~          constant reporting through personal data-collection devices, such as electronic diaries,~          can help prevent relapse and reinforce abstinence. This constant reporting is known as~          Ecological Momentary Assessment (EMA).~        -  The researchers here at NIDA have already completed two major arms of the study,~          focusing on patterns of craving and drug use during methadone maintenance, and on~          whether electronic diaries could help remind outpatients to complete treatment tasks. An~          ongoing arm of the study is examining connections among drug craving/use, stress, and~          geographical location.~      Objective:~      - To investigate the role of stress associated with geographical location in drug craving and~     use.~      Eligibility:~      - Individuals between 18 and 65 years of age or older who are dependent on opioids (cocaine~     and/or heroin).~      Design:~        -  The study will last 28 weeks. After the initial screening, participants will receive~          daily methadone and weekly drug counseling sessions that will continue throughout the~          study.~        -  After 3 weeks of methadone treatment, participants will have 15 weeks of EMA in which~          they will record both event-triggered cravings and daily responses (3 per day). EMA will~          consist of event-triggered recordings (initiated by participants whenever they use~          heroin or cocaine, or whenever they feel an urge to do so) and random-signal-triggered~          recordings (3 per day). During EMA, participants will begin a voucher-based program to~          encourage abstinence from heroin and cocaine.~        -  Participants will also carry global positioning system (GPS) units to record their~          locations during these 15 weeks, and will complete questionnaires about stress levels at~          specific intervals during the study.~        -  At the end of the study, participants will have the choice of transferring to a~          community clinic or undergoing an 8-week taper from methadone.~   "
249091|NCT00292123|"~     The primary goal of this study is to determine how contingency management can best be~     combined with standard or high doses of methadone to increase simultaneous abstinence from~     heroin and cocaine.~   "
249092|NCT00292110|"~     Background:~      - The treatment of addiction often hinges on preventing relapse into drug-using behaviors,~     which occurs at high rates even after prolonged abstinence. Some methadone patients continue~     to abuse cocaine and heroin during treatment, even with extensive psychosocial services. More~     research is needed to look at the results from earlier studies of continued drug use during~     methadone treatment, focusing on the results of fixed vs. flexible doses of methadone to~     reduce the likelihood of continued drug use and the role of monetary vouchers as an incentive~     to continue abstinence from illicit substances.~      Objectives:~      - To determine if the combination of flexible methadone dosing and voucher-based contingency~     management can improve rates of abstinence from heroin and cocaine.~      Eligibility:~      - Individuals between 18 and 65 years of age or older who are dependent on opioids (cocaine~     and/or heroin).~      Design:~        -  The study will last 40 weeks. After the initial screening, participants will receive~          daily methadone and weekly drug counseling sessions that will continue throughout the~          study.~        -  After 6 weeks of methadone treatment, participants who continue to use heroin and~          cocaine will be randomized to one of four groups for 16 weeks of study. Each group will~          receive a flexible or fixed dose of methadone, and one of two contingency management~          conditions.~        -  Flexible-dose participants will receive individualized dose increases, based on drug use~          and withdrawal. Fixed-dose participants will be set at a specific dose of methadone that~          will not be changed.~        -  The two contingency management conditions will be monetary vouchers given for regular~          cocaine-negative urine samples, or vouchers independent of urine cocaine screen results.~        -  After the study phase, participants will have 10 weeks of standard individual counseling~          and stable doses of methadone. Urine samples will continue to be collected, but no~          vouchers will be given.~        -  At the end of the study, participants will have the choice of transferring to a~          community clinic or undergoing a 10-week taper from methadone.~   "
249093|NCT00292097|"~     The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from~     endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic~     brain-injured patients requiring prolonged mechanical ventilation.~   "
249094|NCT00292084|"~     This is an extension study of HCV-05-002. The objective of this study is to evaluate the~     safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for~     an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.~   "
249095|NCT00292071|"~     This is an open-label study of MK0991 in children between 3 to 24 months of age with new~     onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of~     caspofungin.~   "
249096|NCT00292058|"~     Psychiatric consultation and short-term follow-up will produce equivalent clinical outcomes~     and be less costly when provided via videoconferencing (telepsychiatry) than when provided~     in-person.~   "
249097|NCT00292045|"~     This is an open-label, fixed-dose study of immunization with NY-ESO-1 protein combined with~     CpG as adjuvant in patients with high-risk stage D1 or advanced prostate cancer~      Eligible patients will receive vaccinations consisting of 100µg NY-ESO-1 protein combined~     with 2.5mg CpG administered intradermally every 3 weeks for 4 doses.~   "
249098|NCT00292032|"~     The CASPER will collect systematic clinical assessments of patients and families within the~     multicenter Canadian Inherited Heart Rhythm Research Network. Unexplained Cardiac Arrest~     patients and family members will undergo standardized testing for evidence of primary~     electrical disease and latent cardiomyopathy along with clinical genetics screening of~     affected individuals based on an evident or unmasked phenotype.~   "
249099|NCT00292019|"~     This is a pilot study to evaluate the role of RALRP in the management of localized prostate~     cancer.~   "
249100|NCT00292006|"~     The purpose of this study is to find out whether computerized tomography will be better than~     plain radiographs in determining pediatrics scaphoid fractures.~   "
249101|NCT00291993|"~     Obstructive sleep apnea syndrome is complicated by considerable cardiovascular morbidity and~     mortality, at least partly due to hypertension. Nocturnal hypoxia, hypercapnia and acidosis~     stimulate chemoreceptors and presumably increased secretion of vasoactive hormones which~     might be responsible for hypertension in these patients.~      The aim of this study is to measure the secretion of vasoactive hormones at night and to~     analyse the relationship between vasoactive hormones, oxygen saturation and the blood~     pressure at night.~   "
249102|NCT00291980|"~     The immune response of uraemic patients to hepatitis B vaccination is impaired compared to~     healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As~     the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more~     immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this~     population.~   "
249103|NCT00291967|"~     To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with~     that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals’ Hiberix™~     vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly~     administered with Wyeth Lederle’s meningococcal C conjugate vaccine (Meningitec™), with~     respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP)~     after a three-dose primary vaccination course.~   "
249104|NCT00291954|"~     Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg~     surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a~     benefit for this population.~   "
249105|NCT00291941|"~     The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an~     improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral~     immune responses after the primary vaccination course.~   "
249106|NCT00291928|"~     The purpose of this trial is primarily to investigate the safety profile of HuMax-CD20 in~     patients with active RA. Furthermore, the trial is designed to identify the dose levels to be~     used in future trials (based on evaluations of safety, pharmacokinetics and ACR and DAS~     responses).~   "
249107|NCT00291915|"~     Evaluation of two treatment modalities in early potentially severe early arthritis (~     Methotrexate alone or in combination with adalimumab)~   "
249108|NCT00291902|"~     Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary~     heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).~   "
249109|NCT00291889|"~     Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three~     doses of primary vaccination followed by a booster dose after completion of primary~     vaccination course. Booster vaccination will be given only to subjects receiving the~     candidate tuberculosis vaccines and not to the subjects receiving active comparators or~     control.~   "
249146|NCT00291408|"~     The purpose of the study is to compare histone acetyltransferase (HAT) and histone~     deacetylase (HDAC) expressions and activities in induced sputum macrophages obtained from~     patients with moderate to severe COPD and age-matched normal non-smokers~   "
249110|NCT00291876|"~     The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150,~     162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a~     2 dose vaccination schedule of hepatitis A vaccine.~      This protocol posting deals with objectives & outcome measures of the extension phase at year~     11 to 20.~      No additional subjects will be recruited during this long-term follow-up.~   "
249111|NCT00291863|"~     This study will analyse the effect of simvastatin on endothelium dependent venodilation in~     chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that~     patients will have a greater endothelium dependent venodilation after four months of~     simvastatin use.~   "
249112|NCT00291850|"~     A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose~     - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant~     chemotherapy in this patient population.~   "
249113|NCT00291837|"~     The purpose of this sudy is to determine the response rate of CT-2106 in patients with~     advanced ovarian cancer who have failed one prior platinum and taxane based regimen.~   "
249114|NCT00291824|"~     The purpose of this trial is to study the effects on risk reduction and expense of 3~     approaches to the care of people with cardiovascular risk factors in a naturalistic primary~     care environment.~   "
249115|NCT00291811|"~     The purpose of this program is to provide access to AMD3100 for patients who would benefit~     from an autologous stem cell transplant but who have either previously failed to collect~     enough cells for transplant following standard therapy or are not considered by their~     physician to have a reasonable chance of collecting enough cells for transplant.~   "
249116|NCT00291798|"~     The objective of the present clinical investigation is to determine whether hormonal therapy~     given preoperatively is able to reduce tumor size to an extent that facilitates~     breast-conserving procedures.~   "
249117|NCT00291785|"~     CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors~     designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to~     normal tissues. The objective of this study is to determine the dose limiting toxicities,~     safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for~     the treatment of colorectal cancer.~   "
249118|NCT00291772|"~     The purpose of this study is to see if giving the study drug in a slow and steady dose will~     lower blood sugars during the meal and after-meal time.~   "
249119|NCT00291759|"~     The purpose of this study is to assess the difference in event-free survival between~     postmenopausal women with hormone receptor-positive early breast cancer who switched from~     tamoxifen to anastrozole and those who continued to receive tamoxifen.~   "
249120|NCT00291746|"~     The primary objective of this study is to determine the accuracy of the Reflux Disease~     Questionnaire (RDQ) as a diagnostic test for gastroesophageal reflux disease. Symptom~     evaluation by the RDQ will be compared with other established approaches to the diagnosis of~     gastroesophageal reflux disease (GERD) in a primary care patient population with symptoms~     thought to be of upper gastrointestinal (GI) tract origin.~   "
249121|NCT00291733|"~     Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge~     characteristics of basal ganglia. From the other hand, LEV which shares a different~     electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of~     abnormal neuronal firing in experimental models of epilepsy. LEV also reduces~     levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates priming phenomenon~     which associated with long-term changes in synaptic function that can lead to dyskinesias in~     PD.~      Study objectives :~        -  To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo~          on disabling dyskinesias that develop as result of long-term treatment with levodopa,~          occurring at the time of maximal clinical improvement in patients with Parkinson's~          disease (PD).~        -  To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.~   "
249122|NCT00291720|"~     Patients with kidney failure have a poor survival rate that is due to a much higher than~     average rate of heart and vascular disease. The reason that kidney failure causes heart~     disease is unknown but recent research suggests that a hormone called aldosterone, which is~     increased in patients with kidney disease may damage the heart and blood vessels.~      The investigators propose, using a randomized blinded trial, to find out whether drugs that~     inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in~     patients with kidney failure~   "
249123|NCT00291707|"~     The purpose of this Phase I study is to determine the safety and effectiveness of two~     chemotherapies drugs, Cetuximab and Pemetrexed (Alimta), when given in combination with~     radiation therapy.~   "
249124|NCT00291694|"~     To assess the effects of twelve months of celecoxib administration by evaluating breast~     tissue needle aspirations, to determine if cell growth can be slowed.~   "
249125|NCT00291681|"~     Our overall objective in this study is to study the role of B cells in inflammatory bowel~     disease (IBD), using a combination of high-throughput experimental and novel bioinformatical~     techniques.~      Idiopathic IBD includes Crohn's disease (CD) and Ulcerative Colitis (UC), which are chronic~     inflammatory disorders of the intestine. IBD is common in developed countries, with up to 1~     in 200 of individuals affected by theses diseases. It is currently thought that the disease~     arises owing to a complex array of genetic, environmental and immunologic susceptibility~     factors. T cells are thought to cause the lesions, but the B cell population apparently has a~     significant role as well, through secreting antibodies against certain self-antigens. We~     believe that a major contribution to the understanding of the pathogenesis of IBD, and~     especially of the immune pathway leading to CD, can be achieved by analysis of the B cell~     clones participating in immune responses in the gut, in particular their immunoglobulin (Ig)~     variable region gene diversity, which has never before been studied in the context of IBD.~      The adaptive immune system is one of the only two biological systems capable of continuously~     learning and memorizing its experiences. This is a highly complex, distributed system, in~     which pathogen recognition, decision-making and action are performed by an interacting~     network of diverse lymphocytes. Immune learning and memory are embedded in the dynamical~     states of the complete lymphocyte repertoire, and cannot be understood by studying the~     behavior of single cell types. This complexity, further increased by the non-linear behavior~     of each component, can only be elucidated by using theoretical tools to complement~     experimental and clinical studies. Needless to say, many aspects of the deregulation of~     lymphocyte clones are not evident in the phenotype of the single cell but rather in the~     population dynamics of a whole clone (or many clones) of cells, as in B cell lymphomas. Such~     aspects are best elucidated by studies of the population dynamics and genetics of the~     relevant B cell clone(s).~      In this study, we propose to utilize a novel bioinformatical approach – the analysis of the~     shapes of Ig gene mutational lineage trees. This is the main innovative feature in our~     proposal, as it taps into parameters that have never before been measured or analyzed with~     respect to B lymphocytes in IBD. While the method is new, it has already been shown that~     graphical analysis of B cell lineage trees and mathematical quantification of tree properties~     provide novel insights into the mechanisms of normal and malignant B cell clonal evolution. A~     preliminary analysis of lineage trees from other autoimmune diseases (shown below) indicates~     that, given sufficient amounts of data, the method could elucidate changes in Ig gene~     diversification and selection in IBD patients.~      Moreover, we aim to search for correlations between the parameters characterizing Ig gene~     diversification and parameters characterizing patients, disease history and severity, and~     histological markers, as this has the potential of yielding novel diagnostic and prognostic~     tools.~   "
249126|NCT00291668|"~     This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in~     patients with Crohn's disease.~   "
249127|NCT00291655|"~     For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from~     newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175~     (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the~     treatment, to receive treatment with levetiracetam until the monotherapy indication for~     levetiracetam is granted in Europe.~      To continue to assess safety of levetiracetam as per adverse event reporting and observation~     of weight changes.~   "
249128|NCT00291642|"~     The purpose of the study is to assess the efficacy comparability of cetirizine and~     levocetirizine, by comparing the effects of single intake of the two drugs to placebo in~     reducing symptoms of SAR in ragweed sensitive adult subjects exposed to ragweed pollen in an~     Environmental Exposure Unit.~   "
249129|NCT00291629|"~     This trial was performed to evaluate the safety of G-CSF based stem cell therapy and to~     compare outcome of intracoronary infusion of mobilized PBSCs between patients with AMI and~     OMI.~   "
249130|NCT00291616|"~     The purpose of this study is to determine the optimal treatment duration of antiviral therapy~     for chronic hepatitis B.~   "
249247|NCT00290030|"~     To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention~     associated with BPH.~      To assess the safety of alfuzosin in this population and health care consumption.~   "
249131|NCT00291603|"~     Background:~      The new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany)~     features a number of technological improvements that may benefit the patient. This includes~     the use of the advanced high-flux polysulfone membrane, Helixone®, which has an extremely~     high endotoxin retaining capability. Theoretically leading to reduced systemic inflammation~     in the patient, which is an important factor for morbidity and mortality with dialysis.~      The dialysis membrane is the first to be manufactured using membrane-spinning procedures~     (nano-controlled spinning technology) that enables the membrane to be modulated at the~     nano-scale level. The resultant membrane is able to extremely efficiently remove middle~     molecules, along with minimal loss of albumin.~      These features may lead to improved patient outcomes, including reduced systemic inflammation~     and improved quality of life.~      Aims:~        1. To assess the short-term effects of the FX-class Dialyser on quality of life in stable~          haemodialysis patients~        2. To assess the short-term effects of the FX-class Dialyser on inflammatory markers in~          stable haemodialysis patients.~   "
249132|NCT00291590|"~     Management of chronic diseases, such as diabetes, relies upon the health care providers and~     the patients self-care. Self management programs for diabetes that target self-empowerment~     tools have been found to be effective in some studies, but have not typically included~     individuals on Medicaid.~      Our goal for this trial was to observe if patients participating in such a program could~     decrease glycated hemoglobin levels, improve health status and improve self-care practices.~   "
249133|NCT00291577|"~     This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with~     docetaxel in patients with metastatic or locally recurrent breast cancer who have not~     received chemotherapy treatment in the advanced disease setting.~   "
249134|NCT00291564|"~     The purpose of this study is to gather information on how doctors program particular settings~     on cardiac resynchronization therapy implantable cardiac defibrillators (CRT-Ds), to analyze~     how these settings affect the amount of cardiac resynchronization therapy (CRT) patients~     receive and to evaluate the therapy approach for converting abnormally fast heartbeats into~     normal heartbeats. There are no experimental devices or procedures involved in this study.~   "
249135|NCT00291551|"~     This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor~     Ventricular Support System when used to treat patients with heart failure. The implant, which~     is loaded onto the delivery system, is placed over the epicardial surface of the right and~     left ventricles.~      No formal hypothesis testing will be performed; descriptive statistics will be used to~     summarize patient outcomes. The results of the study will be used to guide the design and~     sample size estimation of future studies.~   "
249136|NCT00291538|"~     In this open-label randomised phase I trial, bortezomib will be administrated to 2 groups of~     10 patients with MM who have inclusion criteria use the extended 2nd line indication, either~     intravenously (group 1 = 10 patients) or subcutaneously (group 2 = 10 patients). The schedule~     of administration of bortezomib will be the following : 1.3 mg per square meter of~     body-surface area twice weekly for 2 weeks, followed by 1 week without treatment, for up to~     eight cycles, either IV (group 1) or SC (group 2).~      The primary objective is to characterize the pharmacokinetics of the 2 routes of~     administration.~      The secondary objectives are to characterize the pharmacodynamics (20S proteasome inhibition~     in whole blood), toxicity, including cardiac safety, and efficacy of the 2 routes of~     administration.~   "
249137|NCT00291525|"~     Various patient groups with the On-X Valve can be maintained safely on lower doses of blood~     thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard~     dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.~   "
249138|NCT00291512|"~     This project studies the effectiveness of a sexual risk reduction intervention among HIV+ Men~     who have Sex with Men (MSM) and who use methamphetamine.~   "
249139|NCT00291499|"~     The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg~     tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint~     osteoarthritis.~      Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's~     Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during~     the treatment with the tested product, Condrosulf®, versus placebo.~   "
249140|NCT00291486|"~     The purpose of this clinical trial is to determine whether it is safe to treat patients with~     advanced colorectal cancer, with humanised A33 antibody tagged with radioactive iodine~     (131I-huA33) in combination with chemotherapy (capecitabine).~   "
249141|NCT00291473|"~     Mixed cancer vaccines, CHP-HER2 protein and CHP-NY-ESO-1 protein, are to be studied to~     evaluate the safety and immune responses in patients who are positive either or both~     antigens. Nine patients will be enrolled, who are refractory to standard therapies for cancer~     or at high risk to relapse. CHP-HER2 and CHP-NY-ESO-1 are subcutaneously given on bimonthly~     basis, together with OK-432(Picibanil) as an immunoadjuvant. Six doses will be given.~     Toxicity profiles will be monitored, and antigen specific humoral anad T cell responses will~     be described.~   "
249142|NCT00291460|"~     The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients~     improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk~     within six minutes.~   "
249143|NCT00291447|"~     The purpose of this clinical trial is to describe the toxicity, biodistribution,~     pharmacokinetics and tumour uptake of a single infusion of ch806 (tagged with a trace amount~     of radioactive 111-Indium: 111In-ch806) in patients with advanced tumours expressing the 806~     antigen.~   "
249144|NCT00291434|"~     The aim of our study was to evaluate the value of two different altered fractionation~     schedules – hyperfractionation and accelerated fractionation with concomitant boost – in~     comparison with conventional fractionation in primary definitive radiotherapy for squamous~     cell carcinomas of the larynx, oropharynx or hypopharynx. The study began and was conducted~     while the only teletherapy unit in our department was the cobalt-60 machine. During that~     period we were expecting the installation of new sophisticated equipment. We assumed that the~     results of this study would be also able to show whether or not it would be rational to use~     the altered fractionation regimens on the new machines.~   "
249145|NCT00291421|"~     The purpose of this study is to collect and compare information regarding the treatment and~     outcome of patients diagnosed with Alzheimer's disease who are receiving either drug or~     nondrug treatment. Information will be collected from patients and their primary caregivers.~   "
249147|NCT00291395|"~     Before , during and after intravenous administration of PGI2 we score/measure headache, rCBF,~     blood flow in middle cerebral artery and diameter of superficial temporal artery/radial~     artery and correlate that to known patophysiology of headache to see if PGI2 is involved in~     headache pathophysiology.~   "
249148|NCT00291382|"~     This double-blind, stratified, parallel group study is to determine whether aiming for 'Total~     control' results in better airway hyper-responsiveness than maintaining the treatment level~     at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in~     PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will~     enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow),~     symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma~     exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung~     function measurements and airway hyper-responsiveness will be measured.~   "
249149|NCT00291369|"~     The PERCY Quattro trial has been designed to evaluate the survival benefit of two cytokine~     treatments, Interleukin-2 (IL2) and/or alpha interferon (IFN), for patients with intermediate~     chance of response in metastatic renal cell carcinoma.~      Eligible patients will be randomly assigned in a two-by-two factorial design to either~     medroxyprogesterone (MPA), subcutaneous IFN, subcutaneous IL2, or a combination of IFN and~     IL2.~      The primary objective of the study is overall survival; secondary objectives are~     progression-free survival, response rate, toxicity, and quality of life.~   "
249150|NCT00291356|"~     This is a study to compare the safety, blood concentrations, and effects of GSK189075,~     GW869682, and placebo when dosed for 2-weeks by mouth to patients with type 2 diabetes.~   "
249151|NCT00291343|"~     This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of~     age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™~     ACWY full dose stage at 24 to 30 months of age all subjects will receive a dose of~     Mencevax™ ACWY. In the Mencevax™ ACWY small dose stage at 30 to 36 months of age, the first~     75 subjects in each of the two centers will be tested for boostability of the MenA and MenC~     immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting~     has been updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
249152|NCT00291330|"~     The purpose of this trial is to determine the comparative safety and efficacy of dabigatran~     etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to~     maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute~     symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a~     parenteral anticoagulant approved for this indication. This trial aims to demonstrate~     non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE.~     After achieving non-inferiority, this trial also aims to establish superiority (by means of~     hierarchical tests) of dabigatran over warfarin.~   "
249153|NCT00291317|"~     Regular exercise is strongly recommended to help maintain a healthy lifestyle. Unfortunately,~     children and young adults with damaged spinal cords may not be able to exercise regularly.~     However, there is an exercise bike specially designed for persons with damaged spinal cords~     that enables them to pedal by directly stimulating the muscles in their legs. Our study is~     designed to determine the benefits of exercise for Spinal Cord Injured (SCI) patients using~     this bike.~   "
249154|NCT00291304|"~     Magnetic Resonance Imaging (MRI) is a well known imaging tool for the investigation and~     diagnosis of breast cancer, used in addition to breast mammograms and ultrasound. Recent~     publications suggest that MRI may be the best test to use in women who have very dense~     breasts, have a family history of breast cancer and have had breast cancer and were treated~     with breast saving measures. MRI has been shown to be a better tool to show multiple breast~     cancer spots than mammography or ultrasound. The radiologists and the radiology students will~     have the opportunity to review the MRI scans along with the breast ultrasound and mammography~     films and the pathology reports from the breast cancer surgery completed at the CCI. This may~     enable them to learn how the various subtypes of breast cancer look on MRI. The goal is: 1)~     to gain good breast MRI expertise, giving the Radiology residents a complete diagnostic~     program. 2) to develop good MRI breast experience, enabling the Cross Cancer Institute to be~     the centre of excellence for Breast MRI for northern Alberta.~   "
249155|NCT00291278|"~     This study will compare bone mass in women with a history of endometriosis, a disease in~     which the lining of the uterus grows on nearby tissues, to that of women who have not had~     endometriosis. Endometriosis may be treated with medication or surgery, or both. Because~     uterine tissue grows more when estrogen levels are high, medical treatment is designed to~     lower estrogen. Decreased estrogen, however, is often associated with weak bones and hot~     flashes. Also, women with endometriosis may have lower bone density as a consequence of their~     disease. This study will look at bone density in these women, particularly to see if areas~     other than the lower back may be affected.~      Regularly menstruating women between 40 and 50 years old, with or without a history of~     endometriosis, may be eligible for this study. Candidates are screened by telephone; women~     with endometriosis are asked to provide documentation of their endometriosis before beginning~     the study.~      Study participants undergo the following tests and procedures:~        -  Medical history and blood sample collection~        -  Questionnaires about exercise activity, calcium intake, menstrual cycle history,~          cigarette use and medication history~        -  DEXA scan: This test evaluates the strength of the bones in the back, wrist, and hip.~          The DEXA scanner uses low-energy x-rays to determine bone density. Scans are done of the~          lower spine, upper thigh, hip, and the entire body. For the test, the subject lies on~          the scanning table. Each scan takes about 3 minutes, and the entire procedure may take~          as long as 1 hour.~   "
249196|NCT00290706|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving gemcitabine together with bortezomib may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when~     given together with gemcitabine and to see how well they work in treating patients with~     relapsed or refractory B-cell or T-cell non-Hodgkin's lymphoma.~   "
249248|NCT00290017|"~     This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed plus~     placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy~     regimen.~   "
249156|NCT00291265|"~     This study will test the accuracy of a new home-use electronic device that measures and~     records small changes in Parkinson's disease symptoms, such as tremor and impaired movement~     and speech. The testing is done at home and the results are sent by Internet to the patient's~     doctor. Detecting Parkinson's disease in its early stages may permit doctors to provide early~     treatment and slow the rate of disease progression.~      Patients with early Parkinson's disease (less than 5 years) with rest tremors and~     bradykinesia (slowness and difficulty of movement) who are not taking medications for the~     disease may be eligible for this study. Candidates are screened with training and practice in~     using the home monitoring device over 2-3 weeks. Those who demonstrate proficiency with the~     device may be enrolled in the study.~      Participants undergo the following tests and procedures:~      Baseline Visit~      Participants' undergo symptoms ratings using the Unified Parkinson's Disease Rating Scale and~     assessments of memory, thinking and depression.~      At-home testing~      Participants begin at-home testing with the monitoring device after the baseline visit and~     repeat the tests weekly for 6 months. The test information is automatically uploaded to a~     home computer (provided by the study) and sent to the investigators via Internet. The test~     procedure is as follows:~        -  Introduction questionnaire (1 minute): Participants are questioned about how they are~          feeling at test time.~        -  Pegboard test (4 minutes): At the sound of a tone, the participant moves eight pegs from~          the right to the left using their right and then left hand.~        -  Tapping test (3 minutes): At the sound of a tone, the participant alternately presses~          two buttons with the right index finger and then the left index finger.~        -  Reaction time/movement time testing (3 minutes): At the sound of a tone, the participant~          moves his or her index finger from one button to the other, first with the right hand~          and then with the left hand.~        -  Digitography testing (4 minutes): At the sound of a tone, the participant alternates~          between pressing two keys with the index and middle fingers.~        -  Speech + Actiwatch tremor data upload (7 minutes): The participant: 1) takes a deep~          breath and says ahhh for as long as possible; 2) is shown a picture and, at the sound~          of a tone, is asked to tell a story about the picture; 3) uploads the tremor data from~          the Actiwatch (a device worn on the wrist that records tremors).~        -  At specified times du...~   "
249157|NCT00291239|"~     40 patients with the diagnosis of major depression are included. There are two interventions:~     partial sleep deprivation (PSD) and normal night sleep (CTRL). Patients are randomly assigned~     to PSD-(2 undisturbed nights)-CTRL or CTRL-(2 undisturbed nights)-PSD. Cytokine-status,~     neuropsychological and psychopathometric status are assessed pre and post each interventional~     and control condition.~   "
249158|NCT00291226|"~     Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors~     in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with~     glycine to a greater degree than with placebo.~   "
249159|NCT00291213|"~     This is a placebo-controlled study designed to learn if levetiracetam is effective for~     tardive dyskinesia.~   "
249160|NCT00291200|"~     This study will gather information on the natural history of the basic symptoms of psychosis~     to identify factors that may affect the improvement or persistence of the symptoms.~   "
249161|NCT00291187|"~     The purpose of this study is to determine the safety and efficacy of VEC-162 compared to~     placebo to improve sleep parameters in a model of insomnia.~   "
249162|NCT00291174|"~     This is a research study to evaluate the electrical properties of heart tissue. The purpose~     of this study is to determine the impedance (electrical resistance) of different tissues on~     the outer surface of the heart. This may be important for distinguishing scarred heart muscle~     from fat that can be seen on the surface of the heart. This information may eventually be~     utilized in patients that undergo a procedure (called catheter ablation) for the treatment of~     life-threatening heart rhythms. Investigators expect a detectable difference between the~     impedance of normal and infarcted myocardium (approximately 50 ohms).~   "
249163|NCT00291161|"~     Background: Partners in Dementia Care (PDC) is a care coordination and support service~     intervention for veterans with dementia and their family caregivers, delivered through~     partnerships between VA medical centers and local Alzheimer's Association Chapters. PDC was~     designed to be a feasible and practical intervention to integrate health, community, and~     support services. PDC has a standardized protocol for care coordination and support services,~     including guidelines for care plan assessment, care plan development and implementation,~     ongoing monitoring, and reassessment. It also offers a structured training curriculum for~     providers and an operations manual for uniform implementation.~      Objectives: The primary objective was to test the impact of PDC on outcomes for veterans with~     dementia and family caregivers. Two specific research objectives and corresponding hypotheses~     were addressed: 1. To test the impact of PDC on three categories of outcomes: psychosocial~     well-being outcomes (patient and caregiver effects); health care service use (patient effects~     only); and health care cost (patient effects only). HI:PDC, compared to usual care, will~     improve psychosocial well-being for patients with dementia and their caregivers. H2:PDC,~     compared to usual care, will reduce health care service use for patients with dementia.~     H3:PDC is preferred to usual care based on cost-benefit analyses. H4:The PDC intervention~     will be more effective in improving psychosocial well-being and reducing health care service~     use for patients and caregivers dealing with more severe patient impairment (e.g., cognitive~     status, functional status, and level of problem behaviors). 2. To evaluate the impact of PDC~     on role and intra-psychic strains caused by dementia and its care (patient and caregiver~     effects). H5a:PDC, compared to usual care, will decrease patient role and intra-psychic~     strain. H5b:PDC, compared to usual care, will decrease caregiver role and intra-psychic~     strain. H6:The PDC intervention will be more effective in decreasing role and intra-psychic~     strains for patients and caregivers dealing with more severe patient impairment (e.g.,~     cognitive status, functional status, and level of problem behaviors).~   "
249164|NCT00291148|"~     This is a comparative drug trial involving patients with clinically definite Multiple~     Sclerosis and documented neuropathic pain. Patients will be randomized to receive treatment~     with either paroxetine or pregabalin. After dose titration, participants will complete~     various pain scale assessments at several points during the study in order to determine the~     effectiveness of their assigned pain medication.~   "
249165|NCT00291135|"~     A pilot study to assess the effects of six months of letrozole on breast tissue risk markers~     in postmenopausal women on hormone replacement therapy at high risk of developing breast~     cancer.~   "
249166|NCT00291122|"~     To assess the quantitative real time PCR results results of oligonucleotide probes for a~     number of gene transcription products that may be useful as predictors of indicators of~     response to celecoxib.~   "
249167|NCT00291109|"~     To assess the quantitative real time PCR results of oligonucleotide probes for a number of~     gene transcription products that may be useful as predictors or indicators of response to~     letrozole~   "
249168|NCT00291096|"~     The overall goal of this project is to develop an integrative system of breast cancer risk~     assessment based on epidemiologic and biologic risk variables, as well as to develop or~     refine risk biomarkers which may be useful in predicting and monitoring response to~     prevention interventions.~   "
249169|NCT00291083|"~     To examine nipple aspirate fluid for secretions that may be identified as a high risk~     indicator for development of breast cancer, and compare those to serum analysis.~   "
249170|NCT00291070|"~     This study will examine the effects of L-theanine (an amino acid found in green tea) on the~     behavior, cognitive performance and sleep quality of boys with ADHD.~   "
249171|NCT00291057|"~     In a previous phase II study, the safety and efficacy of a novel formulation of malathion~     0.5% was evaluated in patients 2 years of age and older. Based on the results of that study,~     this formulation is currently in a phase III study for that population.~      The current study will use blood markers and clinical evaluations to determine the safety and~     tolerability of this formulation when used in children 6-24 months of age.~   "
249264|NCT00289809|"~     The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined~     with ifosfamide and then the efficacy of this combination in terms of overall response rate,~     time to progression and time of response~   "
249265|NCT00289796|"~     This study will assess immunogenicity, safety and reactogenicity of primary and booster~     vaccination.~   "
249172|NCT00291044|"~     Brief summary: The current management guidelines recommended by ACOG rely on history as a~     screening method to determine pregnant women who are at risk for transmitting herpes to their~     newborn. History fails completely in identifying the women most at risk of transmitting~     herpes to their newborn - the seronegative woman who acquires a primary infection from her~     partner during pregnancy. Despite recent advances, both pregnant women and newborns continue~     to be at risk of acquiring herpes infection. Genital herpes infections are epidemic in the~     United States. In the early 1990's, 25% of women in the US were seropositive for the HSV-2~     antibody. These numbers are likely higher now. The incidence of neonatal herpes in the US~     cannot be accurately estimated since it is not a reportable disease. However, in some areas~     of the US, the incidence is 1 in 3,200 live births which would translate to an incidence of~     approximately three infants a day in the US . In other areas of the US, the incidence is even~     higher, approaching 1 in 1,500 liveborns. This protocol examines patient acceptance of HSV-1~     and HSV-2 type specific serologic testing and assesses patient counseling tools. In addition,~     seroprevalence of HSV-2 in pregnant patients will be collected and evaluated.~   "
249173|NCT00291031|"~     The purpose of this study is to determine whether Imagery Rehearsal Therapy(IRT) is effective~     in the reduction of the number of nightmares and the nightmare distress in a population of~     patients with psychiatric disorders.~   "
249174|NCT00291018|"~     The objective of this clinical investigation is to compare the safety and effectiveness of~     ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of~     symptomatic cervical disc disease (SCDD).~   "
249175|NCT00291005|"~     -  To evaluate the overall tumor response rate in subjects with metastatic hormone~          refractory prostate cancer~        -  To evaluate PSA (tumor marker) response rate~        -  To evaluate safety~   "
249176|NCT00290992|"~     Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed~     hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma~     uric acid concentration.~      Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP~     antibodies, and pharmacokinetic parameters.~   "
249177|NCT00290979|"~     -  To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro~          in terms of the change in HbA1C from baseline to endpoint.~        -  To compare the safety of HMR1964 with insulin lispro.~   "
249178|NCT00290966|"~     Phase II:~      Primary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with~     cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III~     survival comparison against the CDDP + 5-FU control arm.~      Secondary objective: to evaluate the quantitative and qualitative safety profile of the 2~     test groups.~      Phase III:~      Primary objective: to detect a statistically significant increase in time to progression~     (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm~     (cisplatin plus 5-FU).~      Main secondary objective: to detect a statistically significant increase in overall survival~     (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm~     (cisplatin plus 5-FU).~      Other secondary objectives: to compare response rates, time to treatment failure, duration of~     response, safety profiles, quality of life and disease-related symptoms.Socio-economic data~     will be collected in order to be able to perform an analysis by country when necessary.~   "
249179|NCT00290953|"~     To demonstrate an increase in overall survival for patients with newly diagnosed extended~     stage small cell lung cancer when treated with SR48692 versus placebo, after an initial~     response (complete or partial response or stable) to first line cisplatin plus etoposide.~      Primary objective: comparison of overall survival between patients in the control arm and the~     meclinertant arm.~      Secondary objectives: comparison of the progression free survival, the time to progression,~     the clinical benefit, the quality of life, the toxicity and safety between patients in the~     control arm and the meclinertant arm.~   "
249180|NCT00290940|"~     This study will compare glucose lowering with CS-917 compared to placebo after 3 months of~     treatment~   "
249181|NCT00290927|"~     -  To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as~          compared with OHA therapy.~        -  To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA~          therapy.~        -  To evaluate the safety of HMR1964.~   "
249182|NCT00290914|"~     The purpose is to evaluate the safety and usefulness of the investigational drug, vilazodone~     in depression.~   "
249183|NCT00290901|"~     This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for~     patients with chronic low back pain, when administered over a 6-week period.~   "
249184|NCT00290888|"~     Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with~     several procedures currently being used to treat the tear. The two most common treatments at~     this point in time are arthroscopic cuff repair with and without acromioplasty. However, an~     arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as~     one that includes acromioplasty, but without threatening the shoulder stability that is~     provided by the acromion and coracoacromial ligament. This prospective study examines the~     hypothesis that appropriate shoulder function can be restored through the execution of the~     traditional arthroscopic cuff repair without acromioplasty.~   "
249197|NCT00290693|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel~     works in treating patients with recurrent or progressive metastatic pancreatic cancer.~   "
249198|NCT00290680|"~     RATIONALE: Bortezomib and celecoxib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Giving bortezomib together with celecoxib may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and~     celecoxib in treating patients with advanced solid tumors.~   "
249297|NCT00289367|"~     The purpose of this project is to see whether treatment with a thyroid hormone, called~     triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial~     fibrillation.~   "
249700|NCT00284063|"~     The purpose of this continuation project is to use MRI to evaluate gapping of the~     zygapophysial (Z) joints following side-posture positioning and side-posture spinal adjusting~     in subjects with acute low back pain.~   "
249185|NCT00290875|"~     Many thousands of trauma patients are seen in Canadian emergency departments each year. On~     rare occasions, such patients have a broken neck (cervical spine fracture) but in 98 percent~     of cases the xrays ordered by the doctors are normal. The total cost of inexpensive but high~     volume tests such as neck x-rays adds considerably to rising health care costs. In addition,~     these patients are often immobilized with uncomfortable backboards and collars for many~     hours, tying up valuable space and time in our crowded emergency departments.~      This research group recently developed and tested a highly accurate and reliable guideline~     called the Canadian C-Spine Rule to help physicians be much more selective in their use of~     neck x-rays and to minimize the period of immobilization. This research project will evaluate~     the true effectiveness of the Rule when implemented with simple and inexpensive measures.~     This study will involve 14,000 patients in 12 busy emergency departments across Canada.~      This Canadian C-Spine Rule is designed to allow physicians to be much more selective in their~     use of neck xrays without the risk of missing a fracture or dislocation of the neck and to~     reduce the length of time of immobilization. Widespread use of the guideline could lead to~     large savings for our health care systems without jeopardizing patients and could greatly~     expedite care of trauma patients in our crowded emergency departments.~   "
249186|NCT00290862|"~     Doctors are studying an investigational treatment to be used during the vertebroplasty~     procedure when treating vertebral compression fractures (spine fractures) that may help to~     reduce pain and restore mobility. If one has experienced back pain for at least 4 weeks but~     not longer than 1 year, he/she may be eligible to participate.~      The purpose of this protocol is to describe the methods for the clinical evaluation of~     Cortoss for vertebroplasty in patients with painful osteoporotic compression fractures.~      Eligible patients with painful osteoporotic compression fractures of the spine are divided~     into two groups. Each enrolled patient will have the vertebroplasty procedure; however one~     group of patients will have the vertebroplasty procedure using polymethylmethacrylate [PMMA]~     (a Food and Drug Administration [FDA]-approved bone cement) and the other group of patients~     will have the vertebroplasty procedure using a relatively new (investigational) biomaterial~     called Cortoss.~   "
249187|NCT00290849|"~     The objectives of this registry are to assess the use of the thrombin-specific anticoagulant~     bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In~     particular, data will be collected to analyze experiences of bivalirudin use in respect to~     the following objectives;~        -  examine the aspects of safety and effectiveness of bivalirudin~        -  gain experience regarding the characteristics of patients in bivalirudin treatment~        -  evaluate the handling of bivalirudin and its practicality~   "
249188|NCT00290836|"~     The overall objective is to compare efficacy and safety of TachoComb H versus standard~     surgical treatment for the control of local bleeding in patients undergoing prostatectomy.~     Specific objectives include the comparison between test treatments for intraoperative~     haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin~     and haematocrit concentration of drainage fluid.~   "
249189|NCT00290823|"~     The purpose of this study is to determine whether a short course of increased corticosteroid~     dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid~     dosing in patients with neurocysticercosis (NCC).~   "
249190|NCT00290810|"~     This phase II trial is studying how well bevacizumab works in treating patients with relapsed~     or refractory B-cell chronic lymphocytic leukemia. Monoclonal antibodies, such as~     bevacizumab, can block cancer growth in different ways. Some block the ability of cancer~     cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood~     flow to the cancer.~   "
249191|NCT00290771|"~     This was an investigational study to assess the objective overall response (OOR) rate~     (complete response [CR] + partial response [PR]) of imatinib mesylate and hydroxyurea~     (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme~     (brain tumors). This study also evaluated the duration of tumor response (as per MacDonald~     criteria), clinical benefit, progression-free survival rate at 6 and 12 months, and the~     survival rate at 12 and 24 months.~   "
249192|NCT00290758|"~     This randomized phase II trial is studying how well genistein works in preventing breast~     cancer in women at high risk for breast cancer. Chemoprevention is the use of certain drugs~     to keep cancer from forming, growing, or coming back. The use of genistein may prevent breast~     cancer in women at high risk for breast cancer.~   "
249193|NCT00290745|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor~     cells or by lowering the amount of estrogen the body makes.~      PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating~     women with ductal carcinoma in situ.~   "
249194|NCT00290732|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill more~     tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~      PURPOSE: This phase I trial is studying the side effects and best dose of liposomal~     doxorubicin when given before mastectomy in treating women with invasive breast cancer.~   "
249195|NCT00290719|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     gefitinib together with chemotherapy and radiation therapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase I/II trial is studying the side effects of gefitinib when given together~     with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they~     work in treating patients with esophageal cancer or gastroesophageal junction cancer that can~     be removed by surgery.~   "
249310|NCT00289198|"~     The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg~     once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent~     subjects (12 years of age and older) with perennial allergic rhinitis (PAR).~   "
249199|NCT00290667|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others~     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,~     such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy works in treating older patients with previously untreated B-cell lymphoma.~   "
249200|NCT00290654|"~     RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor~     to kill tumor cells. Giving internal radiation therapy using a special radiation therapy~     device may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy~     works in treating women with ductal carcinoma in situ.~   "
249201|NCT00290641|"~     RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, and~     radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the~     growth of cancer cells. It also stops the patient's immune system from rejecting the donor's~     stem cells. The donated stem cells may replace the patient's immune system and help destroy~     any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from~     a donor can also make an immune response against the body's normal cells. Giving cyclosporine~     and mycophenolate mofetil after the transplant may stop this from happening.~      PURPOSE: This clinical trial is studying how well giving chemotherapy together with~     total-body irradiation followed by donor umbilical cord blood transplant, cyclosporine, and~     mycophenolate mofetil works in treating patients with hematologic cancer.~   "
249202|NCT00290628|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood~     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When the stem cells from a related or~     unrelated donor, that do not exactly match the patient's blood, are infused into the patient~     they may help the patient's bone marrow to make stem cells, red blood cells, white blood~     cells, and platelets.~      PURPOSE: This clinical trial is studying how well donor umbilical cord blood transplant works~     in treating patients with hematologic cancer.~   "
249203|NCT00290615|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Cetuximab and bevacizumab~     may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving~     capecitabine together with cetuximab, oxaliplatin, and bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving capecitabine together with~     cetuximab, oxaliplatin, and bevacizumab works in treating patients with metastatic or~     recurrent colorectal cancer that cannot be removed by surgery.~   "
249204|NCT00290602|"~     The purpose of this study is to determine whether the 2mg/kg administration of~     corticosteroids, in the form of methylprednisolone sodium succinate, in early phase acute~     respiratory distress syndrome after thoracic surgery, will reduce the postoperative~     mortality.~   "
249205|NCT00290589|"~     Low back pain is a common symptom that functionally disables many people. When the low back~     pain is accompanied by pain that shoots down the leg, it is felt to be caused by a herniated~     disc. We are conducting this study to determine if a powerful anti-inflammatory agent will~     decrease the pain and functional impairment that is associated with this illness.~   "
249206|NCT00290576|"~     Symbiotic interaction between probiotics (Living alimentary microbials supplemental,~     affecting positively host by improving intestinal microbial equilibrium (Fuller, 1989)) and~     human digestive tract was amply experimented and seems to be an interesting solution to~     orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic~     supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group.~     Nevertheless, our aim is to test clinical efficiency of two new probiotics strains.~     Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21)~     and safety (Adverse Events) in very premature babies.~   "
249207|NCT00290563|"~     This study is designed to investigate whether a new drug may offer safe and effective~     treatment for patients with overactive bladder.~   "
249208|NCT00290550|"~     This is a study to evaluate the effectiveness of an investigational drug in patients with~     cancer of the lung.~   "
249209|NCT00290537|"~     The goal of this clinical research study is to learn how the drug ZD6474 affects the amount~     of tumor cell death in the body and the amount of blood that can be supplied to the tumor.~     The safety of ZD6474 alone and when given with chemotherapy will be studied. In addition, the~     side effects and response to this treatment will also be studied.~   "
249210|NCT00290524|"~     This study wants to address the question of whether or not oral alimentation should be begun~     early in patients following colorectal surgery compared to the classical diet which depends~     on reappearance of functional intestinal transit. Early oral alimentation following~     colorectal surgery may decrease hospitalisation stay duration.~   "
249226|NCT00290303|"~     The purpose of this study is to compare the immune response, safety and reactogenicity of~     Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B~     vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not~     carry hepatitis B virus) at 6, 10 & 14 weeks of age. This study will also include a small~     group of infants born to mothers who do carry hepatitis B virus; these infants will receive a~     birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6,~     10 & 14 weeks age.~   "
249339|NCT00288821|"~     The purpose of the study is to determine the diagnostic accuracy of a new magnetic resonance~     imaging (MRI) technique, the diffusion weighted imaging with body background signal~     suppression (DWIBS) in the detection of lymph node pathology in patients with gynaecologic~     malignancies.~   "
249340|NCT00288808|"~     Investigate the validity of Hemosense System in pediatric patients on anticoagulation~     therapy.~   "
249211|NCT00290511|"~     The goal of this clinical research study is to learn if chemotherapy given with rituximab,~     followed by Ibritumomab tiuxetan (Zevalin), and then followed by rituximab can help to~     control lymphoma. The safety of this treatment schedule will also be studied.~      Objectives:~        1. To assess whether the time to progression for these high-risk patients can be prolonged~          to a median of 36 months, compared to the historical expectation of approximately 24~          months.~        2. To assess the tolerance and efficacy of Y2B8 (Zevalin) after R-FND (rituximab,~          fludarabine, mitoxantrone, dexamethasone) in patients with high-risk stage III-IV~          follicular lymphoma~        3. To assess overall response, failure-free survival, and survival of this strategy~          compared to our historical experience with FND (fludarabine, mitoxantrone,~          dexamethasone) alone or R-FND~        4. To assess the tolerance and efficacy of maintenance therapy with rituximab.~        5. To maximize the 12-month molecular remission rate for patients with high-risk stage~          III-IV follicular lymphoma~        6. to correlate the results of quantitative PCR assay with classical PCR and with clinical~          outcome~   "
249212|NCT00290498|"~     The overall goal of this clinical research study was to find out which of two different~     chemotherapy drug combinations, R-CHOP and R-HCVAD, is more effective in treating B-cell~     lymphoma.~      At this point, all participants will now be assigned to the R-HCVAD arm of the study.~     Researchers will study the safety and effectiveness of this drug combination.~   "
249213|NCT00290485|"~     The aim of this study is to demonstrate that the use of Gleevec in initially non-resectable~     gastrointestinal stromal tumors can lead to allow complete resection in 20% of cases.~   "
249214|NCT00290472|"~     Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from~     dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works~     in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic~     lymphocytic leukemia.~   "
249215|NCT00290459|"~     This proposal seeks to retain discard pieces of human gynecologic tissues and discard~     ascites fluid collected during normal surgical procedures, along with corresponding blood~     samples and urine, for research involving prognostic markers of disease/cancer. The specific~     aims of the proposal include:~        1. To collect discard pieces of benign, pre-malignant and malignant gynecologic tissues,~          discard ascites fluid and, when possible, corresponding blood and urine specimens from~          patients undergoing:~             1. hysterectomy~             2. excisions of cervical dysplasia and/or venereal warts, and~             3. therapeutic excisional surgeries to remove gynecologic disease/cancer (uterine,~               ovarian and lower female genital tract).~             4. paracentesis for the symptomatic relief of ascites fluid accumulation (distention).~        2. To collect pre-operative blood and urine from patients along with pre- operative blood~          work drawn for clinical evaluation.~        3. De-identify the patients from their donated tissue, blood and urine specimens by~          assigning a laboratory identification number.~        4. Rapidly process and store the collected specimens to preserve biological integrity.~          (RNA, DNA and proteins)~        5. Collect and record the patient's demographic and medical information into a research~          database under the assigned lab number only.~        6. Assess the specimens for prognostic markers of gynecologic disease/cancer by molecular~          techniques such as DNA arrays,immunohistochemistry and ELISA.~   "
249216|NCT00290433|"~     The goal of this clinical research study is to learn if treatment with two types of~     chemotherapy combinations can help to control peripheral T-cell lymphoma.~   "
249217|NCT00290420|"~     The purpose of this study is to determine which, between weekly prophylaxis or malaria attack~     treatment, both by chloroquine, is the most appropriate way to protect women and foetus from~     P. vivax malaria infection during pregnancy.~   "
249218|NCT00290407|"~     The purpose of this study is to determine how well subjects respond to treatment with~     Rituximab plus Beta-Glucan.~   "
249219|NCT00290394|"~     The purpose of this study was to determine the effects of rosiglitazone in normotensive type~     2 diabetic patients with regard to its blood-pressure–reducing effects.~   "
249220|NCT00290381|"~     This is the first proof of concept study for OC000459 and is undertaken to assess the effects~     of the compound on the development of inflammatory cytokines in a model (nasal allergen~     challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be~     compared with placebo in the study.~      The study will be a randomised, double blind, placebo controlled, crossover evaluation of the~     effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects~     with a known history of allergic rhinitis and screening positive to allergen will be~     included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed~     and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety~     parameters will be monitored throughout.~   "
249221|NCT00290368|"~     This is a non-drug, biomarker study to assess the utility of the model of repeated nasal~     allergen challenges in subjects with atopic rhinitis as a method of inducing an increased~     response to inhaled allergen, which will more closely resemble the responses seen during the~     hayfever season.~   "
249222|NCT00290355|"~     Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed~     to assess the safety of the treatment and its ability to induce an immune response.~   "
249223|NCT00290342|"~     DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of~     combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been~     updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
249224|NCT00290329|"~     GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal~     Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to~     collect clinical data in the local target population in order to assess the occurrence of~     rare adverse events after vaccination as per the requirement of Philippines Bureau of Food~     and Drugs Directive.~   "
249225|NCT00290316|"~     The diagnostic accuracy of EUS for detection of the liver tumors (primary and metastatic)~     remains unknown. To compare the accuracy of the EUS and CT scan for detection of the primary~     and metastatic carcinoma of the liver.~   "
249246|NCT00290043|"~     To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and~     RHI (HOE31HPR100) injected subcutaneously before and after a standard meal~   "
249227|NCT00290290|"~     Most cases of infection of clean-contaminated wounds (wounds without gross spillage of~     organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore,~     it is conceivable that application of an optimal antiseptic agent can reduce the rate of~     surgical wound infections. This trial is to compare the impact of disinfecting the skin with~     Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection~     of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse~     effects on the skin from either antiseptic agent and the cost-savings associated with the use~     of Chloraprep vs Betadine.~   "
249228|NCT00290277|"~     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.~     Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can~     lead over time to cervical cancer in women . This study will evaluate the immunogenicity and~     the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.~   "
249229|NCT00290264|"~     The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with~     treatment according to conventional best practice in adolescent and adult patients with~     persistent asthma.~   "
249230|NCT00290251|"~     This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine~     fibroids in pre-menopausal women.~   "
249231|NCT00290238|"~     The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy~     when compared to a reference sham treatment in the treatment of patients who have undergone~     surgical intervention for chronic low back pain with or without a radiating lower extremity~     pain component.~   "
249232|NCT00290225|"~     Study hypothesis: that a standardized course of Eastern practices (Breath Water Sound Course~     -BWS) will significantly relieve PTSD and depression in tsunami victims. Further, that a~     client-centered exposure treatment (Traumatic Incident Reduction- TIR) would provide~     additional, significant relief of PTSD and depression in tsunami victims.~      180 tsunami victims in Southern India will be divided into three groups: those that only~     receive BWS course, those that receive the BWS course and TIR and a wait-list control. They~     will be pretested with the PCL-17 (PTSD scale), the Beck Depression Inventory and the General~     Health Questionaire. These scales will also be administered post-service as well as five~     weeks post pre-testing and at three and six month intervals.~   "
249233|NCT00290212|"~     Study Objective: To determine whether Natto supplementation in women immediately after~     menopause might prevent severe bone loss~      Study population: Women 50 - 60 years, 1-5 years after menopause~      Study Design: Double-blind, placebo-controlled, randomized controlled trial. A phase II~     clinical trial.~      Instruments Used to Measure Therapeutic Response: Lunar Prodigy DEXA bone densitometer~      Study Treatment Group: Daily supplementation with Vitamin K2, NATTO~      Study Control Group: Identically-looking placebo medication~      Duration of treatment: 12 months~      Duration of Subject Participation in Study: 12 months Assessment of Therapeutic response:~     Given an expected reduction of bone mass density of - 1.1% annually in the placebo group, the~     minimum clinically significant difference between the groups is 0.3 percentage points. The~     trial is therefore powered to detect a reduction in annual bone mass loss of 0.3 percentage~     points in the treatment group.~      Numbers of Evaluable Subjects Required: 304 Maximum # Subjects 334~   "
249234|NCT00290199|"~     In women undergoing labor induction for membrane rupture at or near term, we are~     investigating the addition of a foley catheter placed in the cervix to standard therapy~     (oxytocin administration) to decrease the time from the start of the induction to delivery.~   "
249235|NCT00290186|"~     The study is to evaluate the effectiveness of hyperbaric treatments and the potential~     longer-term effects in children between the ages of 3 and 8 years with spastic cerebral palsy~     (CP). One group will receive 100% oxygen and the other group will receive the equivalent of~     21% oxygen (room air). The children will receive pre-treatment testing (baseline). After 40~     experimental treatments are completed, the children will be retested at 0, 3, and 6 months to~     evaluate any changes.~   "
249236|NCT00290173|"~     This is a trial comparing the efficacy of oral ritodrine in the form of sustained release~     capsules for the maintenance of uterine quiescence after successfully treated episode of~     threatened preterm labor.~   "
249237|NCT00290160|"~     Evaluate if early protein supplementation decreases the incidence of hyperkalemia in~     Extremely Low Birth Weight Infants (babies less than 1,000 grams birth weight).~   "
249238|NCT00290147|"~     The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.~   "
249239|NCT00290134|"~     The purpose of this study is to determine whether one or more fispemifene dose regimens are~     more effective than placebo in the treatment of hypogonadism in older men.~   "
249240|NCT00290121|"~     The purpose of this study is to understand, with the use of functional magnetic resonance~     imaging, the neural correlates involved in appetite control and the mechanism of weight gain~     in patients with schizophrenia treated with atypical antipsychotics. We hypothesize that a~     difference in cerebral activations between weight gaining and non-weight gaining patients~     will be detected after four months of treatment with olanzapine.~   "
249241|NCT00290108|"~     The aim of the present study was to investigate whether injection rate of propofol has an~     influence on its maximum effect.~   "
249242|NCT00290095|"~     The purpose of this study is to determine Clinically important difference and Response shift~     in quality of life in patients with Multiple Myeloma.~   "
249243|NCT00290082|"~     Neuroleptics are used since a long time in the management of severely agitated patients.~     Loxapine is routinely used in our country, with, to our knowledge no severe adverse event~     reported, in this indication.~      However, recently, benzodiazepines have appeared interesting in agitated patients, with the~     use of midazolam.~      The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated~     patients admitted in the emergency department.~   "
249244|NCT00290069|"~     The main aim of this study is to compare the renal function (serum creatinine at 6 months) in~     the later introduction of tacrolimus or rapamycin based in immunosuppressor regimes with~     daclizumab, mycophenolate mofetil, and steroids in patients older than 50 years of age who~     are the recipients of a graft from donors aged 55 years and older.~   "
249245|NCT00290056|"~     We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of~     arrhythmic events among post-MI, ICD recipients.~   "
249249|NCT00290004|"~     The primary purpose of this study is to evaluate the safety, toxicities, dosage and response~     rate for an investigational drug, motexafin gadolinium, administered to patients with chronic~     lymphocytic leukemia or small lymphocytic lymphoma. The secondary purpose of this study is to~     evaluate the clinical benefit rate, the time it takes for a patient's chronic lymphocytic~     leukemia or small lymphocytic lymphoma to worsen, the duration of response and the time~     during which patients survive without chronic lymphocytic leukemia or small lymphocytic~     lymphoma worsening. Additionally, the patient's response to motexafin gadolinium will be~     compared to the response of the patient's cells in a laboratory to motexafin gadolinium.~   "
249250|NCT00289991|"~     Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who~     have had a Stem Cell Transplant. The success of the end point will be measured using evidence~     of Infection, drug compliance and survival.~   "
249251|NCT00289978|"~     This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod~     (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting~     multiple sclerosis (RRMS)~   "
249252|NCT00289965|"~     This project is designed to compare college drinking interventions on outcomes and~     cost-effectiveness. We plan to recruit 700 students with residence hall alcohol violations to~     participate in a randomized study to evaluate 3 brief interventions: in-person brief~     motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a~     Web-based tutorial). Participants will be followed over 12 months to determine changes in~     alcohol consumption and related problems. We will also explore which participants might~     respond better to one intervention vs the others.~   "
249253|NCT00289952|"~     The purpose of this study is to examine whether the co-administration of valproic acid~     (Epival®), with highly active antiretroviral therapy (HAART) can reduce the size of HIV~     latent reservoirs in infected CD4 cells.~   "
249254|NCT00289939|"~     The long-term goal of this work is to reduce the prevalence of HIV and domestic violence~     among women at risk by encouraging self-protective behaviors. To obtain this goal, Multnomah~     County Health Department and Oregon Department of Human Services have conducted a randomized~     trial of an intervention to prevent HIV and domestic violence among women who have recent~     criminal justice involvement and who are at risk for HIV infection.~      Women enrolled in the study were randomly assigned to one of three study conditions:~        -  Group 1: these women received information on local resources addressing HIV prevention,~          domestic violence, and life stability issues; they did not receive any counseling~          sessions as part of the study itself.~        -  Group 2: these women received up to ten supportive counseling sessions based on the~          techniques of motivational interviewing. These sessions aimed to reduce HIV risk and to~          improve life stability.~        -  Group 3: these women received up to ten supportive counseling sessions based on~          motivational interviewing. These sessions aimed to reduce risk for HIV and domestic~          violence and to improve life stability.~      The primary hypotheses of this study were:~        -  1. Supportive counseling (motivational interviewing) addressing HIV prevention and~          increased life stability will lead to reductions of HIV risk behavior among women~          enrolled in the study.~        -  2. Supportive counseling (motivational interviewing) addressing domestic violence~          prevention, HIV prevention, and increased life stability, will bring about reductions in~          experiences of domestic violence and a reduction of HIV risk among these women.~        -  3. The supportive counseling received in this study will enhance these women's~          self-efficacy, self-esteem, and psychological well-being.~      Women in all three experimental groups were interviewed at the beginning of the study and~     again after 4, 7, and 10 months. These assessment interviews asked questions about: HIV risk;~     experiences of domestic violence; and life stability issues such as education, employment,~     and housing; and included biological testing for HIV and sexually transmitted diseases. Women~     in Group 2 and Group 3 participated in up to 10 sessions of supportive counseling~     (motivational interviewing) between the time of enrollment and the 4-month interviews.~   "
249255|NCT00289926|"~     This study is designed to evaluate the efficacy and safety of oral Dehydroepiandrosterone~     (DHEA) 50mg daily, for 12 months in naturally menopausal women with low libido who are not~     receiving systemic oestrogen or oestrogen- progestin therapy.~      Efficacy measures for the present study are effects on sexual function, wellbeing and~     menopausal symptoms. Safety measures will include endometrial assessment by transvaginal~     ultrasound (TVU), vital signs, lipid profiles, general electrolytes, effects on glucose~     metabolism and reports of adverse events.~   "
249256|NCT00289913|"~     This two-stage study evaluates the immunogenicity, safety, and tolerability of the~     administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™~     (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria~     and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the~     administration of VAQTA™ in healthy children 15 months of age at study entry.~   "
249257|NCT00289900|"~     This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the~     effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A~     coadministered with simvastatin) will be superior to atorvastatin on decreasing the low~     denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio~     for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg~     MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg~     MK-0524B versus 80 mg atorvastatin.~   "
249258|NCT00289887|"~     This is a 16-week study to evaluate high systolic and diastolic blood pressure following~     treatment in obese, hypertensive, adult patients.~   "
249259|NCT00289874|"~     This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma~     which is also active during allergy seasons in pediatric patients with seasonal aeroallergen~     sensitivity.~   "
249260|NCT00289861|"~     We propose a double-blind, placebo-controlled trial to study the effectiveness and~     tolerability of adding risperidone to stable yet only partially remitted patients with~     schizophrenia maintained on clozapine.~   "
249261|NCT00289848|"~     This is a clinical study to determine the safety and efficacy of an investigational drug in~     patients with type 2 diabetes mellitus.~   "
249262|NCT00289835|"~     HYPOTHESIS~        1. Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis~          progression as evaluated by IVUS.~        2. Sealing moderate SVG lesions with the TAXUS stent does not accelerate SVG~          atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by~          IVUS.~      OBJECTIVES~        1. To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting~          stent in comparison with medical treatment on limiting SVG disease progression as~          evaluated by IVUS.~        2. To evaluate by IVUS the effect of stenting moderate SVG lesions with the~          paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis~          progression in angiographically non-diseased SVGs segments.~   "
249263|NCT00289822|"~     Impaired contractile function after a heart attack and due to coronary heart disease is a~     major cause of heart failure limiting quality of life and prognosis, which cannot be~     prevented even with optimal standard therapy.~      The aim of the current trial is to investigate whether infusion of progenitor cells into the~     coronary artery supplying the most dyskinetic left ventricular area may improve left~     ventricular contractile function, compared to no cell infusion in the control group, in~     patients with old (>= 3 months) myocardial infarction.~   "
249266|NCT00289783|"~     This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and~     the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving~     licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy~     infants at 2, 4, and 6 months of age. The study will also evaluate the safety and~     immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib~     conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15~     months of age.~   "
249267|NCT00289770|"~     The aim of this study is to evaluate the long-term persistence of hepatitis A and B~     antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3~     dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol~     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.~      This protocol posting deals with objectives & outcome measures of the extension phase at Year~     11-15.~   "
249268|NCT00289757|"~     The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at~     11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a~     2 dose vaccination schedule of hepatitis A vaccine.~   "
249269|NCT00289744|"~     The aim of this study is to evaluate the long-term persistence of hepatitis A and B~     antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary~     vaccination schedule of combined hepatitis A/hepatitis B vaccine.~      This protocol posting deals with objectives & outcome measures of the extension phase at year~     6 through to 10.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
249270|NCT00289731|"~     The focus of this study is to evaluate how risk factors like age, gender, body mass index,~     smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated~     with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and~     B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been~     updated in order to comply with the FDA Amendment Act, Sep 2007.~   "
249271|NCT00289718|"~     The aim of this study is to evaluate the long-term persistence of hepatitis A and B~     antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a~     3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting~     has been updated in order to comply with the FDA Amendment Act, Sep 2007.~      This protocol posting deals with objectives & outcome measures of the extension phase at year~     11 to 15.~   "
249272|NCT00289705|"~     The purpose is to study whether the positive effects from obesity surgery in adults also can~     be achieved when adolescent subjects are operated.~      Our hypothesis is that the effects concerning weight loss, health improvement and improved~     quality of life will be as good in adolescents as in adults.~   "
249273|NCT00289679|"~     To evaluate the concentration of cytokines and metal ions in blod samples and biopsies from~     patients undergoing a hip revision.~   "
249274|NCT00289666|"~     This study is designed to determine the effect of continuous positive airway pressure (CPAP)~     or bi-level positive airway pressure (BiPAP) on heart rate variability (HRV) in patients with~     obstructive sleep apnea (OSA).~   "
249275|NCT00289653|"~     Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide~     levels from the levels they were before they started using the patch. Subjects will also~     decrease their daily consumption of cigarettes, change how they smoke the cigarette, and will~     show reduced reactivity to smoking-related cues and reduced craving.~   "
249276|NCT00289640|"~     The purpose of this clinical research study is to compare the best overall response rate~     (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory,~     or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of~     0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.~   "
249277|NCT00289627|"~     The purpose of this clinical research study is to evaluate the Best Overall Response Rate~     (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III~     (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this~     product will also be evaluated.~   "
249278|NCT00289614|"~     The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity~     following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with~     moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced~     multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to~     48-72 hours post dose.~   "
249279|NCT00289601|"~     This study is a randomized, double-blind, multi-center study designed to compare differences~     in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24~     hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or~     clopidogrel non-responsive patients who are randomized to heparin with or without~     eptifibatide therapy during PCI. The primary objective of this study is to determine if the~     use of eptifibatide is associated with a significant difference in post-PCI myonecrosis~     (measured as an elevation of CK-MB ratio ≥ 2 times upper limit of normal [ULN]) within 24~     hours of low-medium risk PCI in patients who are aspirin or non-responsive as determined by~     VerifyNow Aspirin and P2Y12 testing.~   "
249280|NCT00289588|"~     The main purpose of this study is to determine if applying mupirocin into soldiers noses who~     are colonized with methicillin-resistant Staphylococcus aureus (MRSA) will reduce infections~     in them and their cohort of fellow soldiers.~   "
249281|NCT00289575|"~     The aim of this pilot study is to evaluate MBCP performance in bone regeneration after~     osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone~     weakness following the healthy area drilling, thanks to a bone reconstruction at the expense~     of the biomaterial.~   "
249282|NCT00289562|"~     A Phase I/II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride~     Infusion in Patients with B-cell Acute Lymphoblastic Leukemia with an Option of Extended Use~     of Forodesine Hydrochloride~   "
249283|NCT00289549|"~     Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days~     each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour~     prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy~     (28 days).~   "
249701|NCT00284050|"~     This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual~     acuity in patients with diabetic macular edema with center involvement.~   "
249284|NCT00289536|"~     The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial~     recovery (% increase [IU/dL] per IU/kg infused) and major single-infusion pharmacokinetic~     parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not~     have received treatment with a factor VIII concentrate for at least 3 days. Blood samples~     will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48~     hours post-infusion. A washout period of at least 3 days, but no more than 30 days between~     the last blood draw and the next infusion will be observed. During participation, subjects~     will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII~     concentrate.~      A secondary objective is to investigate the relationship between pharmacokinetic parameters~     at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and~     von Willebrand factor antigen at baseline.~   "
249285|NCT00289523|"~     The purpose of this study is to evaluate the potential early EEG predictors of an~     individual's response to treatment with antidepressant medications.~      Objectives:~        -  Prospectively confirm accuracy of current EEG biomarker algorithm~        -  Determine preferred clinical intervention for subjects with negative indicator~        -  Identify predictors of worsening suicide ideation~   "
249286|NCT00289510|"~     The objective of this study is to assess the safety and immunogenicity of inactivated~     influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to~     receive a single injection of whole virion, Vero cell derived or egg derived influenza~     vaccine on Day 0. Subjects will return to the study site for safety evaluation at~     predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn~     at predetermined intervals to measure their immunologic response to vaccination.~   "
249287|NCT00289497|"~     Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course~     of several days. These patients do not feel pain, and do not recognize their foot is being~     injured until a wound develops. Areas about to ulcerate become inflamed and “hot spots” can~     be identified. This study’s purpose is to evaluate the effectiveness of a home infrared~     temperature probe designed to forewarn patients that an area on the foot is inflamed so they~     can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers~     among high-risk patients, evaluate the cost of home temperature monitoring compared to~     standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having~     foot complications will be randomized into 3 treatment arms: 1) standard therapy consisting~     of regular foot care; 2) standard therapy plus recording of a structured foot evaluation~     using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to~     identify “hot spots.” Device patients will measure temperatures at 6 sites on the foot each~     day. When temperatures are elevated >4°F patients will contact the research nurse and~     decrease activity. The primary study outcome will be incident foot ulcers and Charcot~     fractures.~   "
249288|NCT00289484|"~     The purpose of this study is to determine whether augmentation of antidepressant medication~     with Omega-3 polyunsaturated fatty acids increases the speed and degree of improvement for~     patients with major depression~   "
249289|NCT00289471|"~     Veterans who completed GEMS-Phase 1 will be asked to participate in GEMS-Phase 2 to determine~     the accuracy of methods used to assess mild memory problems. This will better help us~     evaluate the screening test completed in GEMS-Phase 1. The goals are:~        1. Compare the assessment of memory made at the initial visit to assessments of memory made~          at the second evaluation.~        2. Determine of veterans with mild memory problems have improvement or worsening of these~          memory problems over time. Our long-term goal remains to optimize the quality of care~          for veterans with cognitive impairment. We will also determine if patient~          characteristics can be used to target case-finding, describe the current process of care~          and evaluate the association between cognitive impairment and overall- and~          dementia-related health care utilization and costs.~   "
249290|NCT00289458|"~     The objective of this project is to determine the effect of aquatic exercise and aquatic~     exercise combined with an education program on decreasing fall risk in older adults with hip~     osteoarthritis. The hypothesis is that aquatic exercise will improve function, strength and~     balance and the addition of the education session will enhance confidence in movement.~   "
249291|NCT00289445|"~     The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C~     (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid,~     and to assess the toxicity and activity in patients with previously treated colorectal and~     gastric cancer. Escalating doses of MMC starting from 6 mg m(-2) in 2 mg m(-2)-steps to a~     maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-FU (2.600 mg~     m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-FU weekly for 6 weeks~   "
249292|NCT00289432|"~     INCAM-study is a multicenter, prospective, randomized controlled trial. The aim of the study~     is to test the effectiveness of psychoeducative intervention when offered in hospital setting~     as a component of routine breast cancer care. The hypotheses are; - that breast cancer~     patients participating in psychoeducative interventions focusing on coping will experience~     better health-related quality of life than those who participate in the hospital standardised~     psychoeducative intervention. - that coping styles are associated with the immune system.~   "
249293|NCT00289419|"~     The purpose of this study is to determine whether wound infiltration with following~     single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment~     of postoperative pain after total hip replacement compared to continuous epidural infusion.~   "
249294|NCT00289406|"~     The goal of this study is to compare the antihypertensive effect and tolerability of~     S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate~     hypertension.~   "
249295|NCT00289393|"~     The purpose of this study is to evaluate the results of elective lumbar spinal surgery as it~     relates to shifting patient expectations for outcome. Patients undergoing elective posterior~     spinal surgery for degenerative conditions of the spine at SWCHSC will be evaluated.~   "
249296|NCT00289380|"~     1. The aim of this large scale study to survey the prevalence of nutritional risk and~          malnutrition in China,Europe and USA.~        2. The impact of nutritional support for the patients at nutritional risk on clinical~          outcomes and cost-effectiveness~      Already get the approval by Ethics Committee of Peking Union medical college and Johns~     Hopkins Hospital.~   "
249298|NCT00289354|"~     To evaluate the effect of the combination of chromium picolinate (600 μg Cr) + biotin (2 mg)~     versus placebo on glycosylated hemoglobin (HbA1c), lipid profiles (Total-C, HDL-C, LDL-C,~     TGs, TG/HDL ratio, etc), and pharmacoeconomic outcomes as measured at the Baseline Visit and~     90 days later at the Final Visit. Secondarily, to measure the effect of chromium picolinate~     (600 μg Cr) + biotin (2 mg) versus placebo on patient quality of life, fasting and~     post-prandial blood sugar levels, fasting insulin, and anti-hyperglycemic medication usage.~   "
249299|NCT00289341|"~     The purpose of this study is to assess the safety and activity of a type of vaccine as immune~     therapy for prostate cancer. This vaccine will be made for each participant's own immune~     cells (called dendritic cells) obtained by blood donation. Dendritic cells are immune cells,~     whose role is to identify foreign antigens (bacteria, viruses, or tumor cells, for example)~     in the body and to activate other cells of the immune system to mount an attack on that~     foreign antigen. Each participant will be randomized into either Arm 1 (experimental~     treatment only) or Arm 2 (placebo first, then the experimental treatment). Participants will~     be given the vaccine and three boosters as an injection. After the placebo phase, each~     participant in Arm 2 will crossover to the treatment phase so that all participants will~     eventually receive the experimental treatment.~   "
249300|NCT00289328|"~     The purpose of this study is to characterize the skeletal deficits and risk factors for~     impaired skeletal development in children requiring glucocorticoid therapy.~      We will compare the bone health of children treated with prednisone for nephrotic syndrome~     (NS with those treated with prednisone for Crohn's Disease (CD). Childhood NS usually~     responds to prednisone and is not characterized by pathologies that can impact on bone. In~     contrast, CD is treated with prednisone, but is independently associated with poor growth and~     maturation, nutritional deficiencies and inflammation. Due to the differences in the~     diseases, this comparison will allow us to distinguish between the prednisone-related and~     disease-related effects on bone in the two disease states.~   "
249301|NCT00289315|"~     There is a worldwide pandemic of obesity with far-reaching consequences for the health of our~     nation. Obesity is the second leading cause of preventable death in the United States.~     Prevention of obesity, especially in children, has been deemed by public health policy makers~     to be one of the most important objectives for our country. Obesity disproportionately~     affects citizens of minority and low socioeconomic status. A consensus of opinion has formed~     that the recently observed increased prevalence of obesity is caused by environmental and~     behavioral factors that favor easy access to high calorie foods and sedentary behavior. This~     prevention project, called LA Health, will test whether modification of these environmental~     and behavioral factors can prevent inappropriate weight gain in children who are enrolled in~     the fourth to sixth grades during Year 1. The primary aims of the LA Health project are to~     test the efficacy of two school-based approaches for obesity prevention. The two approaches~     are derived from two NIH-funded pilot studies called the HIPTeens project (a secondary~     prevention program) and the Wise Mind project (a primary prevention program). The study will~     test the efficacy of primary prevention alone and a combination of primary and secondary~     prevention in comparison to a no-treatment control group using a cluster randomization~     research design, with 18 school clusters from 9 different parishes randomly assigned to the~     three treatment arms. The following parishes were selected for the project: East Carroll,~     Madison, Franklin, East Feliciana, St. John, St. Helena, Pointe Coupee, Avoyelles, and Sabine~     Parishes. Thus far East Carroll, East Feliciana, St. John, Pointe Coupee, and Avoyelles~     Parishes have agreed to participate. We anticipate adding additional parishes in the second~     year of the project.The project will collaborate with a USDE funded project, LA GEAR UP, to~     test the relative efficacy obesity prevention programs for children who come from~     economically disadvantaged environments. The LA GEAR UP program is designed to enhance~     educational achievement. Since LA GEAR UP will be implemented in all 18 school clusters, all~     of the preventions intervention arms, including no-treatment, will be combined with an~     academic enhancement program. The study will span three years and will provide critical tests~     of strategies that modify the child's environment as a primary prevention strategy and~     provide health behavior modification via classroom instruction and internet counseling as a~     secondary prevention strategy. The study will also recruit a similar (but smaller) sample of~     students to measure changes in body weight relative to height, gender, and age over the same~     three-year period. This observation only control group will be studied to evaluate secular~     trends in changes in body weight so that body weight changes observed in the randomized trial~     can be interpreted within the context of stable versus unstable population changes in body~     weight. The results of this investigation will significantly impact public health policy~     related to obesity prevention in rural communities, minority communities, and in children~     from families that are economically disadvantaged.~   "
249302|NCT00289302|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. When there are~     changes in the heart beat sometimes an implantable heart device is used to control the rate~     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of~     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may~     be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the~     upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles~     through three or four leads (soft insulated wires) that are inserted through the veins to the~     heart.~      People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,~     may be in need of an electronic device called an implantable cardioverter defibrillator~     (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it~     sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If~     the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to~     return the heart to its normal rhythm. The InSync ICD device can change the timing of when~     the left and right ventricles of the heart are paced to beat.~      The purpose of this study is to monitor the long-term performance of the InSync ICD Model~     7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).~   "
249303|NCT00289289|"~     The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm~     pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart~     and reduce symptoms (such as shortness of breath, dizziness, and others).~   "
249304|NCT00289276|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. Using very low~     electrical pulses that travel across the inside of the chest cavity, thoracic fluid status~     monitoring (OptiVol™) can measure the level of resistance to the electrical pulses, which~     indicates the level of fluid in the chest. The purpose of this study is to collect~     information related to fluid build up in the chest of subjects with heart failure.~   "
249305|NCT00289263|"~     This is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two~     (262) patients on each arm will be recruited in the study.~   "
249306|NCT00289250|"~     Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is~     followed by a marked increase in the density of gametocytes. To determine whether treatment~     with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to~     receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56~     days to record gametocyte presence and density.~   "
249307|NCT00289237|"~     In spite of declining trend coronary heart disease (CHD) is still a leading cause of~     morbidity and mortality. Many years of epidemiological research have identified several risk~     factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated~     through high blood pressure, high cholesterol and fatness) and smoking. So far intervention~     studies on lifestyle factors have shown disappointing results, most probably due to~     insufficient interventions and methodology.~      Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons~     representing a well-defined population. About 13,000 are invited for a health examination and~     assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three~     waves over a five year period. A priori the group is divided into a high intensive and low~     intensive intervention group. The remaining 48.285 individuals serve as control.~      After five years all individuals who attended the base-line examination are re-invited to~     assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk~     of CHD and biological risk factors. The total cohort (61.301) is followed through central~     registers to evaluate the effect of the intervention on use of the health care system and the~     long term effect on incidence of CHD.~      The status for the project is that the four waves of intervention have been performed, the~     last follow-up was in March 2006.~      Data collection finalized with 10 years follow-up via Central National Registries and a~     questionnaire. No further follow-up is scheduled for the main purposes of the study.~      Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary~     effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin~     off project are on-going.~      More than 25 Ph.d. studies and more than 200 peer-review publication have so far been~     produced.~      Summary of results, links to articles and theses at: www.Inter99.dk~   "
249308|NCT00289224|"~     The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the~     oral killed bivalent cholera vaccine when administered to individual residing in a~     cholera-endemic area in India.~   "
249309|NCT00289211|"~     The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of~     acute HAE attacks.~   "
249311|NCT00289185|"~     GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a~     candidate malaria vaccine GSK 257049 for the routine immunization of infants and children~     living in malaria endemic areas. The vaccine would offer protection against malaria disease~     due to the parasite Plasmodium falciparum. The vaccine would also provide protection against~     infection with hepatitis B virus (HBV).~      In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a~     new variant RTS,S/AS02D (0.5 mL dose) has been developed.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
249312|NCT00289172|"~     Rotavirus disease is the most common cause of gastroenteritis and dehydration in young~     children worldwide. The global public health burden has prompted the development of a human~     rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This~     pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety~     data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of~     the first dose.~   "
249313|NCT00289159|"~     To determine wether multimodal MRI (conventinal T1 and T2 sequences, diffusion, magnetization~     transfer, spectroscopy) is reproducible; to follow up a cohort of patients with early~     remmittent MS after treatment with interferon.~   "
249314|NCT00289146|"~     Examine the effects of renal surgery on the immune system.~   "
249315|NCT00289133|"~     The purpose of this study is to evaluate long-term clinical and radiographic data between~     geometrically identical GVF and cross-linked polyethylene-bearing inserts in total knee~     arthroplasty.~   "
249316|NCT00289120|"~     Examine the effects of cola on risks of kidney stones~   "
249317|NCT00289107|"~     The study will evaluate the clinical performance of the rotating platform and fixed bearing~     implants through patient questionnaires, outcomes scoring and radiographic assessment.~   "
249318|NCT00289094|"~     The purpose of this study is to evaluate the clinical performance of the rotating platform~     and fixed bearing implants in patients undergoing primary total knee replacement. Outcome~     scoring and radiographic assessment will be the methods used to evaluate performance.~   "
249319|NCT00289081|"~     The purpose of the study is to evaluate the clinical performance of the cruciate ligament~     retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs.~     Outcome scoring and radiographic assessment will be the methods used to evaluate performance.~   "
249320|NCT00289068|"~     Incision size in cataract surgery is related to induced surgical astigmatism, chamber~     stability, and surgical efficiency. Sleeves of different diameters change the size of the~     surgical incision and amount of fluid allowed into the eye during the surgical procedure for~     a given set of surgical parameters. Optimization of surgical parameters requires review of~     surgical efficiency including: fluid usage, energy usage, and total surgical time. With~     optimized surgical parameters recommendations can be made to increase the efficiency and~     safety of cataract surgery.~   "
249321|NCT00289055|"~     The main objective of this study is to assess the patency rate of the nitinol self-expandable~     stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to~     angioplasty only.~   "
249322|NCT00289042|"~     SPECIFIC AIM: To test the safety and feasibility of using low molecular weight heparin (LMWH,~     enoxaparin sodium; Lovenox, Sanofi-Aventis) in lieu of unfractionated heparin (UFH) as~     antithrombotic therapy for patients in atrial fibrillation undergoing transesophageal~     echocardiography (TEE) guided chemical or electrical cardioversion to sinus rhythm.~      HYPOTHESIS: Early cardioversion from atrial fibrillation can be safely performed using a~     short-term anticoagulation strategy of low molecular weight heparin (Lovenox, Sanofi-Aventis)~     compared to unfractionated heparin, accompanied by a TEE examination prior to cardioversion.~     The use of LMWH with TEE will result in a safe, cost-effective, and possible efficacious~     approach to cardioversion of atrial fibrillation compared to UFH with TEE.~   "
249323|NCT00289029|"~     The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity~     following the administration of Isovue or Visipaque in patients with moderate to severe renal~     insufficiency undergoing cardiac angiography. Serum creatinine will be measured before and up~     to 48-72 hours after the administration of the contrast agent to evaluate renal function.~   "
249324|NCT00289016|"~     The primary objective of the study was to assess the clinical efficacy of talimogene~     laherparepvec in terms of tumor response rates.~   "
249325|NCT00289003|"~     The purpose of this study is to explore the protective effect and safety of soluble~     beta-1,3/1,6-glucan compared to placebo in oral mucositis in head and neck patients receiving~     radiotherapy or chemoradiotherapy.~      Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities prevent~     oral mucositis~   "
249326|NCT00288990|"~     Study Title: A Serologic Study to Correlate b-IFN NAb titers to b-IFN Induced Biomarker~     Response in Patients with Multiple Sclerosis~      Objectives: Subjects currently on any of the three b-IFN preparations (Avonex (Interferon~     b-1a 30 mcg IM Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Betaseron~     (Interferon b-1b 250mcg SC QOD)) will be enrolled to one of 3 groups:~      Group 1: Approximately 200 subjects will be enrolled who are NAb+ (titer ³ 20NU/ml) Group 2:~     Approximately 50 subjects will be enrolled who are BAb- (titer <8U) and NAb- (titer <20~     NU/ml) Group 3: Approximately 50 subjects will be enrolled who are BAb+ (titer ³8U) and NAb-~     (titer <20 NU/ml)~      The primary objective of this study is to compare baseline b-IFN induced MxA mRNA response in~     neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-,~     titers < 20NU/ml, BAb-, titers <8U, Group 2) patients.~      Secondary objectives are:~        1. To compare b-IFN induced MxA mRNA response in neutralizing antibody positive (NAb+,~          titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers < 20NU/ml, BAb-, titers~          <8U, Group 2) patients at the month 6 visit.~        2. To compare b-IFN induced biomarker response (viperin, IFIT1) in neutralizing antibody~          positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers <~          20NU/ml, BAb-, titers <8U, Group 2) patients (data compared at baseline and month 6~          visits)~        3. To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in neutralizing~          antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. BAb+ (titers ³8U)/NAb- (titers~          <20 NU/ml, Group 3) patients at baseline and month 6 visits.~        4. To correlate NAb titer levels with b-IFN induced biomarker response (data taken from~          baseline and month 6 visits from Group 1).~        5. To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in BAb-/NAb- patients~          (Group 2) vs. BAb +/NAb- patients (Group 3) in order to determine if BAbs affect b-IFN~          induced biomarker response (data compared at baseline and month 6 visits).~      Tertiary objectives are:~      1. To explore patient characteristics that may predict NAb positivity.~      Design: This is a multi-center, open-label study of approximately 300 (200 NAb+ and 100 NAb-~     (50 BAb+ and 50 BAb-)) MS patients that will compare b-IFN induced biomarker response~     following b-IFN injection in neutralizing antibody positive vs. antibody negative patients.~      Study Population: Approximately 300 subjects (200 in Group 1, 50 in Group 2, and 50 in Group~     3) will be recruited for the study.~      Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the~     following eligibility criteria at the time of randomization:~        1. Patients (male or female) diagnosed with relapsing forms of MS.~        2. Currently being treated with the same b-IFN (in accordance with FDA approved dosing and~          schedules) for 12 to 48 months inclusive.~        3. All levels of disability~        4. Age 18-65 years inclusive~        5. Subjects must be willing to be followed for the 6-month study period.~      Exclusion Criteria: Candidates will be excluded from study entry if any of the following~     exclusion criteria exist at the time of study initiation.~        1. Patients with prior b-IFN NAb test (whether positive or negative).~        2. Patients who are currently being treated or have been treated within 6 months prior to~          screening with combination therapy (b-IFN plus any other~          immunosuppressant/immunomodulatory) other than IV steroids (either pulse or for a~          relapse).~        3. Unwillingness or inability to comply with the requirements of this protocol including~          the presence of any condition (physical, mental, or social) that is likely to affect the~          subject's ability to comply with the study protocol.~        4. Any other reasons that, in the opinion of the Investigator, the subject is determined to~          be unsuitable for enrollment into this study.~      Treatment Groups: This is a multi-center, open-label study of approximately 300 (200 NAb+~     patients and 100 NAb- patients (50 BAb+ and 50 BAb-)) relapsing MS patients that will compare~     b-IFN induced biomarker response following b-IFN injection in neutralizing antibody positive~     vs. antibody negative patients.~      Subjects currently on any of the three b-IFN preparations (Avonex (Interferon b-1a 30 mcg IM~     Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Betaseron (Interferon b-1b 250mcg~     SC QOD)) will be enrolled to one of 3 groups:~      Group 1: Approximately 200 subjects will be enrolled who are NAb+ (titer ³ 20NU/ml)~      Group 2: Approximately 50 subjects will be enrolled who are BAb- (titer <8U) and NAb- (titer~     <20 NU/ml)~      Group 3: Approximately 50 subjects will be enrolled who are BAb+ (titer ³8U) and NAb- (titer~     <20 NU/ml)~   "
249327|NCT00288977|"~     Study hypothesis is that we can reproduce results of islet transplantation in type one~     diabetics in patients with a kidney transplant.~   "
249328|NCT00288964|"~     A new artificial lung device has been developed that potentially provides added support to~     mechanical ventilation for severely damaged lungs. The Hattler Respiratory Assist Catheter is~     designed to provide gas exchange (deliver oxygen and remove carbon dioxide) for a period of~     up to 7 days, providing more time for the lungs to improve.~      Extrapolating from large animal data, the hypothesis is that the Hattler Catheter will be~     capable of providing 30% to 40% of the basal requirements of carbon dioxide exchange in a~     manner that is dependable and reproducible.~   "
249329|NCT00288951|"~     The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma~     therapy in patients with open-angle glaucoma or ocular hypertension~   "
249338|NCT00288834|"~     This project proposes to evaluate the relative effectiveness of four therapy protocols for~     pharyngeal phase swallowing impairment in the stroke population. Data derived from this study~     should contribute significantly to our understanding of the rehabilitative process in the~     neurogenic dysphagic population and will provide the foundation for the establishment of~     efficacious, cost-efficient patient services.~      1. Research Question to be addressed~        1. The utilization of SEMG biofeedback monitoring in dysphagia rehabilitation facilitates~          more rapid and complete recovery than traditional rehabilitation using the same~          swallowing exercises without exteroceptive feedback.~        2. Swallowing rehabilitation provided in an intensive rehabilitative programme (10 hrs of~          treatment in the 1st week) facilitates more rapid and complete recovery than~          traditionally scheduled swallowing rehabilitation (twice weekly).~   "
249330|NCT00288938|"~     Background:~        -  Melanocytic nevi, or moles, are non-cancerous growths of a type of skin cell called a~          melanocyte.~        -  Large congenital melanocytic nevi (LCMN) are a special type of mole that begins to grow~          before birth and is larger than moles that develop after birth.~        -  Determining how melanocytes in moles and LCMNs differ from normal melanocytes may~          increase the ability to predict whether a mole will give rise to a melanoma (a type of~          skin cancer)~      Objectives:~        -  To understand how melanomas develop, by studying moles, LCMNs, and pigmented skin~          lesions that are suspicious for melanoma~        -  To develop better criteria for diagnosing melanoma, particularly by using a device~          called a digital dermatoscope (a special camera, connected to a computer, that takes~          pictures of moles when they are magnified and illuminated)~      Eligibility:~        -  Children 5 years old or older with an LCMN~        -  Adults 18 years old or older with 100 or more moles larger than 2 mm in diameter and at~          least one 4 mm or more~        -  Adults 18 years old or older with a pigmented lesion suspicious for melanoma~      Design:~        -  Patients' personal and family health history is obtained.~        -  Patients are examined by investigative team doctors, and several lesions are examined~          with a dermatoscope.~        -  Additional photographs of part or all of the skin surface may be taken.~        -  Some lesions may be biopsied.~        -  Additional tests or examinations may be recommended.~        -  Patients are followed periodically for skin or physical examinations, photography,~          laboratory and imaging evaluations, and possible skin biopsies.~        -  Children may undergo brain magnetic resonance imaging (MRI)~   "
249331|NCT00288925|"~     To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects~     with unresectable advanced pancreatic cancer in order to determine the optimal dosage for~     PhaseII study~   "
249332|NCT00288912|"~     The purpose of this study is to examine whether a telephone-based self-management~     intervention improves pain, physical function, and other outcomes among veterans with~     osteoarthritis of the hip or knee.~   "
249333|NCT00288899|"~     This is a VA Merit Review Study involving 7 VA medical centers participating in a parallel~     group randomized trial comparing repeat back versus standard electronic consent for 4~     common elective surgical procedures (total hip arthroplasty, carotid endarterectomy,~     laparoscopic cholecystectomy, and radical prostatectomy). Baseline covariates include health~     status (SF-12), reading ability (REALM), and demographics. Primary outcomes are patient~     comprehension of the informed consent, patient satisfaction with the informed consent and~     decision making processes, patient satisfaction with care, anxiety (STAI), and provider~     assessment of the repeat back process. In addition, we are electronically capturing data~     detailing time spent in each phase of the consent process including repeat back.~   "
249334|NCT00288886|"~     The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address~     the continuing care adherence needs of veterans presenting for substance use disorder (SUD)~     treatment. Final results of our recently completed HSR&D clinical trial suggest CPR~     meaningfully impacts aftercare adherence and abstinence rates. However, CPR did not impact~     abstinence rates at earlier follow-up points, other important measures of treatment outcome,~     or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites~     has not been established. Thus, the intervention has been modified and pilot testing of this~     improved version of CPR, which includes contingent reinforcement of abstinence and improved~     prompting of AA/NA attendance (CPR+), shows promising results. We are conducting a multi-site~     randomized clinical trial to examine the effectiveness of CPR+. We recruited 183 veterans~     seeking residential treatment at the Salem and Jackson VAMCs. Our primary hypothesis is that~     the CPR group will have higher 1-year abstinence rates compared to the STX group. Our~     secondary hypotheses are that the CPR will be particularly effective for individuals with~     co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in~     aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations,~     and lower costs of care. Treatment outcome will be measured 3-, 6-, and 12-months after~     participants enter treatment and compared to baseline levels. The current study will seek to~     extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing~     care adherence and greater impact on treatment outcome. Dissemination and implementation~     efforts will be ongoing for this brief, inexpensive intervention, which offers an important~     means to improve participation and outcome for individuals seeking SUD treatment within the~     VAMC. Data collection and analysis has been completed.~   "
249335|NCT00288873|"~     Obese persons are known to have elevated levels of parathyroid hormone (PTH) and low levels~     of vitamin D. These hormones are important in regulation of the body’s calcium stores and~     bone health. We would like to investigate these abnormalities and the accuracy of our current~     diagnostic tests by comparing results of standard assays for vitamin D and PTH to more~     specific tests, in obese subjects at baseline and as vitamin D is replaced. We will also~     compare two standard vitamin D replacement regimens to determine if one is more effective.~      This is a pilot study with two parts: Part 1 will compare levels of PTH and vitamin D using~     two different assays in obese subjects who have normal vitamin D and those who do not. We~     plan to enroll 20 subjects who have normal vitamin D levels and 40 subjects who have vitamin~     D insufficiency. All subjects will fill out questionnaires about the amount of calcium and~     vitamin D in their diet, and their recent sunlight exposure. We will ask for blood samples so~     that we can measure levels of calcium, vitamin D, albumin, creatinine, glucose, insulin and~     the different forms of PTH.~      Subjects who have vitamin D insufficiency will then be randomized to receive Vitamin D2 or~     Vitamin D3 in standard doses for eight weeks, in an open label trial. At four and eight~     weeks, these subjects will fill out the above questionnaires and have the blood tests~     repeated. For safety purposes, urine calcium will also be monitored.~   "
249336|NCT00288860|"~     The purpose of this study is to test whether providing PTSD patients additional support by~     telephone (in addition to usual outpatient care) after they discharge from residential~     treatment improves those patients' outcomes and keeps them out of the hospital longer.~   "
249337|NCT00288847|"~     The activation of the knee extensors in adults after patella dislocation.~      The kneecap can dislocate due to an accident or also only due to an interior turn in the~     stretched knee joint out of its sliding bearing. E. Arendt (Arendt 2002) wrote an overview~     work, in which possible causes and working methods to the patella dislocation are discussed.~     Despite almost one hundred quotations the authors are not able find the causes and the~     possible treatment concepts. The study will examined healthy adults (25 female and 25 men)~     and 25 patients with patella dislocation by a routine applied clinical gait analysis and~     surface EMG (after the European SENIAM guidelines) iin the Laboratory for Gait Analysis Basel~     of the Children's University Hospital Basel. The combination of gait analysis and the surface~     EMG with Wavelet analysis may objectify possible reasons for a patella dislocation~   "
249384|NCT00288236|"~     Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes~      Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference,~     HDL-cholesterol, triglycerides - Safety, tolerability~   "
249341|NCT00288795|"~     This research study is being conducted to compare the effectiveness of two types of~     complimentary medicine treatments to see if they will reduce the fatigue experienced by~     breast cancer patients receiving radiation therapy. The treatments being studied are Polarity~     Therapy and Massage Therapy.~      The primary study hypothesis is that Polarity Therapy will be efficacious in relieving~     fatigue in breast cancer patients receiving radiation treatments.~      The secondary hypothesis is that Polarity Therapy will be efficacious in improving~     health-related quality of life in breast cancer patients receiving radiation treatments.~   "
249342|NCT00288782|"~     Recent studies show that 25 – 30% of depressed patients never fully recover, resulting in a~     treatment-resistant condition. Thus, depression is a major cause of human suffering. We are~     interested in finding new ways of identifying and alleviating treatment-resistant depression,~     and we believe that recent advances in brain imaging can contribute to achieving that goal.~     In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented~     for examining the neurochemistry of brain receptors involved in antidepressant actions.~      Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective~     antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic~     receptors that have often been implicated in “stress reactions” as well as depressive~     disorders. We believe that our compound can identify specific molecular brain dysfunctions~     that are causally related to treatment-resistant depression.~      The purpose of this study is to determine whether there is a reliable relationship between~     the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by~     mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and~     region-of-interest data analysis, using healthy volunteers who will receive a daily dose of~     mirtazapine (double-blind design with placebo, 7.5 mg or 15 mg daily for 5 days). We believe~     that this project could provide a procedure for assessing brain function in~     treatment-resistant depression, with the aim of improving the guidelines for successful,~     evidence-based treatment of depression.~   "
249343|NCT00288769|"~     Background:~      Recurrent aphthous stomatitis is a common phenomenon in Primary Medicine.Frequency of the~     phenomenon can be as high as 25% of the general population and the recurrence of the problem~     can be up to 50%.Different approaches for treatment are described: treatment with various~     natural vitamins , local ointments , disinfectant agents for local treatment , local~     antibiotic ointments , NSAID, local cortisone-steroids , and even medication on the basis of~     immune-depressants of the immune system and systematic steroids .~      Methods:~      A double-blind study of daily administration of sublingual Vitamin B12 tablets manufactured~     by Solgar (each tablet containing 1000 mcg. of Vitamin B12) opposed to placebo tablets.~      Purpose of the research:~      To investigate the effect of Vitamin B12 on the frequency of recurrent canker sores of the~     mouth (RAS).~      Study hypothesis:~      Treatment with vitamin B12 will reduce the recurrence rate and will diminish the~     symptomatology of RAS episodes.~   "
249344|NCT00288756|"~     The purpose of this study is to determine if increasing the linear rise rate of injection of~     x-ray contrast in the heart during left ventriculograms(part of a cardiac Catheterization~     procedure) will decrease the incidence of arrythmias and improve image quality?~   "
249345|NCT00288743|"~     There is a growing body of evidence in the literature regarding the adverse effects of~     hyperglycemia in critically ill patients. To target and maintain better blood glucose~     regulation we implemented an insulin protocol with target blood glucose levels between 81-110~     mg/dL.~   "
249346|NCT00288730|"~     The purpose of this study is to assess the safety and efficacy of two doses of intravenous~     NATRECORÂ® hBNP (a recombinant form of the natural human peptide normally secreted by the~     heart) versus placebo in the treatment of patients with symptomatic, decompressed congestive~     heart failure (CHF).~   "
249347|NCT00288717|"~     To investigate the effects of Candesartan and Telmisartan on the home blood pressure, glucose~     and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by~     the newly developed Tele-medicine system~   "
249348|NCT00288704|"~     Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations~     in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1).~     These mutations result in the body's overproduction of interleukin-1 (IL-1), a protein that~     stimulates the inflammatory process. IL-1 Trap (rilonacept) was designed to bind to the~     interleukin-1 cytokine and prevent it from binding to its receptors in the body.~   "
249349|NCT00288691|"~     The aim of this study is to explore effects of the investigational product for the treatment~     of treatment-resistant menorrhagia without organic cause.~   "
249350|NCT00288678|"~     1. To demonstrate a feasible hospital-based diabetic shared care model in Taiwan.~        2. To compare effectiveness of diabetes control between patients receiving case management~          provided by a health manager and patients receiving usual care.~        3. To determine the optimal level of glucose, blood pressure and lipids in control of~          diabetes in Taiwan.~   "
249351|NCT00288665|"~     To study the effect of a simple and fast 'modus operandi' by aspiration of thrombus and~     debris with the Export catheter in an acute occlusion, on microvascular (re)perfusion and~     late left ventricular remodeling. Subsequently determinating if PCI with primary aspiration~     as an adjunct is superior to standard PCI. Microvascular (re)perfusion will be assessed with~     angiographic and electrocardiographic measurements (TIMI frame count, TIMI flow grade, Blush~     score, ST-T segment measurements). Early and late left ventricular function and infarct size~     will be measured with serial MRI imaging.~   "
249352|NCT00288652|"~     The purpose of this study is to determine the effectiveness of different doses of~     [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection~   "
249353|NCT00288639|"~     The objective of study is to assess the clinical improvement (change in seizure frequency),~     safety, and tolerability of subjects with partial seizures following adjunctive therapy of~     pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.~   "
249382|NCT00288262|"~     In many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes~     in reproductive hormones such as luteinizing hormone (LH). Melatonin's effects on human~     reproductive endocrinology are uncertain. It is thought that the same hypothalamic pulse~     generator may both trigger the pulsatile release of GnRH and LH and also cause hot flashes.~     Thus, if melatonin suppressed this pulse generator in postmenopausal women, it might moderate~     hot flashes. This clinical trial tested the hypothesis that melatonin could suppress LH and~     relieve hot flashes.~   "
249354|NCT00288626|"~     The purpose of this study is to determine the effectiveness of a new treatment for multiple~     sclerosis (MS), a serious disease in which the immune system attacks the brain and spinal~     cord. MS can be progressive and severe and lead to significant disability. The study~     treatment involves the use of high-dose chemotherapeutic drugs to suppress the immune system.~     The participant's own (autologous) blood-forming (hematopoietic, CD34+) stem cells are~     collected before the chemotherapy is given, and then transplanted back into the body~     following treatment. Transplantation of autologous hematopoietic stem cells is required to~     prevent very prolonged periods of low blood cell counts after the high-dose chemotherapy.~   "
249355|NCT00288613|"~     Purpose The purpose of this study is to compare the economical impact and clinical parameters~     of short daily hemodialysis using the NxStage® System One hemodialysis device with~     thrice-weekly conventional in-center dialysis using a matched cohort from the US Renal Data~     System (USRDS) database.~   "
249356|NCT00288600|"~     The use of intravenous immunoglobulin G (IVIG) therapy has been reported in~     hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it. Human~     Immunoglobulin is considered an alternative to delay the hemolytic process and consequently~     reduce the number of exchange transfusions and transfusions of red cells concentrate, thus~     diminishing the risk of transmitting transfusional therapies-related diseases. OBJECTIVE: To~     determine the effect of IVIG in decreasing the incidence and severity of neonatal immune~     hemolytic jaundice due to Rh hemolytic disease reducing the need for exchange transfusion as~     a primary goal in these babies. METHODS: This will be a randomized, double blind, clinical~     trial involving all newborns with risk of significant hyperbilirubinemia due to direct~     Coombs-positive Rh hemolytic disease. The primary goal will be need for exchange transfusion~     and others are: incidence of late anemia, kernicterus and deafness Babies were randomly~     assigned into two groups: group 1 (study group) received phototherapy plus IVIG (500 mg/kg);~     and group 2 (control group) received phototherapy and normal saline solution (10 ml/Kg) in~     the first 6 hours of life. Exchange transfusion was carried out in any group if at any time~     the bilirubin level reached 340 micromol/l (20 mg/dl) or more, or rose by 8.5 micromol/l per~     h (0.5 mg/dl per h). Adverse effects will be related in two groups. Parents informed consent~     will be asked in pre-natal time.~   "
249357|NCT00288587|"~     The purpose of this study is to assess the ability of Ultrafiltration to influence the rate~     of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion~     pressure, in patients with NYHA class III/IV Heart Failure.~   "
249358|NCT00288574|"~     This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate~     of relapse of anorexia nervosa (AN) and enhancing the psychosocial and behavioral recovery of~     people who have been treated for AN.~   "
249359|NCT00288561|"~     Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor~     (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal~     injection. The present study is directed towards the assessment of ranibizumab administered~     on the same day in combination with verteporfin in patients with subfoveal CNV secondary to~     ARMD~   "
249360|NCT00288548|"~     We want to study the effect of the combination of metoprolol (a beta-blocker) with formoterol~     (a beta-agonist) on long function in patients with Chronic Obstructive Pulmonary Disease~     (COPD). There are more and more clues that a beta-blocker, when well chosen and in the right~     dosage, won't harm the long function in patients with COPD. Since a beta-blocker can be a~     valuable addition to treating patients with heart problems we would like to see if this~     category of medication can be available for COPD patients in the future.~   "
249361|NCT00288535|"~     This study is a prospective, randomized, single-center evaluation of the Cypher™ Sirolimus~     eluting coronary stent system in the treatment of de novo bifurcated coronary lesions~     comparing provisional modified T stenting with systematic modified T-stenting.~   "
249362|NCT00288522|"~     The main purpose of this study is to evaluate the efficacy and safety of 3 doses of~     Somatuline Autogel 60mg to control the muscle infiltration and edema, eyelid retraction and~     extraocular muscular contraction in patients with active thyroid-associated ophthalmopathy of~     moderate intensity.~   "
249363|NCT00288509|"~     The aim of this study is to assess longer term safety and effectiveness of Dysport®.~   "
249364|NCT00288496|"~     Mechanical bowel preparation (MBP) is common practice in elective colorectal surgery. In~     recent literature the value of MBP is subject of discussion. We conducted a multicenter,~     randomized study with the goal of comparing outcome of elective colorectal resections and~     primary anastomoses with and without mechanical bowel preparation in terms of anastomotic~     leakage and other septic complications.~      Within the setting of a multicenter randomized trial,1433 patients were randomized before~     elective colorectal surgery to receive either MBP or to have no MBP but a normal meal on the~     day before operation. The primary endpoint was anastomotic leakage. Secondary endpoints were~     septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses),~     fascia dehiscence and death.~      The incidence of anastomotic leakage was similar in both groups: 5.1% in patients without MBP~     versus 4.9% in patients with MBP (p=0.93; 95% confidence interval for the difference (no MBP~     minus MBP) ranges from –2.3% tot +2.7%). There were no significant differences in other~     septic complications, fascia dehiscence, or mortality. Fecal contamination, number of days~     until resumption of a normal diet, and duration of hospital stay were similar in both groups.~      This study shows that elective colorectal surgery can be safely done without MBP. Therefore,~     MBP should be abandoned in elective colorectal surgery.~   "
249381|NCT00288275|"~     Chemoresponse assays (lab test) measure the effect that chemotherapy treatment has on a~     patient's cancer cells in the lab. This test has shown success in a retrospective study in~     predicting how an individual patient's tumor will respond to a given chemotherapy and how~     treatment utilizing an agent that the test said that a patient's cells would be sensitive too~     corresponds to a longer progression free interval. This study will determine the ability of~     two tests used to predict the success of chemotherapy in recurrent, persistent, or refractory~     cancer of the ovaries, fallopian tube(s) or peritoneum by measuring how long patients live~     without progression.~   "
249383|NCT00288249|"~     The purpose of this study is to determine whether the study drug is effective and safe in the~     treatment of patients with metastatic breast cancer~   "
249456|NCT00287300|"~     The purpose of this study is to compare the efficacy and safety of three treatment regimens~     for the prevention of malaria during pregnancy.~   "
249365|NCT00288483|"~     Despite undeniable progress in the reduction of morbidity and mortality of coronary heart~     disease (CHD) prevention is a mainstay for medical intervention. The importance of elevated~     serum cholesterol for the formation and progress of CHD can be regarded as proved after the~     results of the major intervention studies became available. These studies have provided key~     evidence for a positive correlation of lipid lowering and decreased mortality. Other studies~     in patients with established CHD have shown that stabilization and regression of~     atherosclerotic lesions is possible with lowering of cholesterol using a variety of agents.~     Different studies have also investigated the long-term effects of lipid lowering strategies~     on atherosclerosis by means of coronary angiography and have demonstrated that lipid~     reduction reduces progression of atherosclerosis and can promote atherosclerosis regression.~     Thus, it has been demonstrated that cholesterol lowering therapy reduces the risk of CHD and~     diminishes cardiovascular morbidity and mortality.~      Policosanol is a drug that presumably possesses both hypocholesterolemic and antiplatelet~     effects. Furthermore there are hints to even more positive effects that influence the~     development of atherosclerosis, i.e. inhibition of LDL peroxidation and smooth muscle cell~     proliferation.~      Previous studies showed efficacy in dose ranges of mostly 5 to 20 mg Policosanol per day. As~     nearly all previous studies have been performed in Latin America it cannot be excluded that~     either ethnic or nutritional factors contribute to the dose found to be optimal in this~     region. This circumstance as well as the requirement to meet the ICH Guideline “Ethnic~     Factors in the Acceptability of Foreign Clinical Data” make further studies, i.e. a~     dose-finding clinical trial, an efficacy clinical trial in European patients and a long-term~     tolerability clinical trial in Caucasian patients necessary.~      It is known from more than 60 clinical studies performed so far that Policosanol has an~     excellent safety profile. A placebo-controlled design was considered appropriate as patients~     with two or more risk factors for the development of cardiovascular events and a LDL of~     greater than 190 mg/dl were excluded; the chance of getting an active lipid-lowering agent~     during the treatment phase was 80 %.~   "
249366|NCT00288470|"~     A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for~     correction of facial wrinkles.~   "
249367|NCT00288457|"~     The Study of whether or not Ureteral Stent Length affects patient comfort after electro-shock~     wave treatment for kidney stones.~   "
249368|NCT00288444|"~     To determine the molecular interaction in tumor samples between docetaxel and lonafarnib.~   "
249369|NCT00288431|"~     This study is designed to determine the safety, tolerability and maximum tolerated dose of~     Oral AP23573 in combination with Doxorubicin~   "
249370|NCT00288418|"~     The main purpose of this study is to determine if the Angiotech central venous catheter (CVC)~     is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in~     preventing bacterial catheter colonization. Other objectives of this study are to determine~     if the Angiotech CVC is equal in effectiveness to a CVC coated with chlorhexidine and silver~     sulfadiazine in preventing catheter-related local infection, and catheter-related bloodstream~     infection. This study will also assess the safety of the Angiotech CVC.~   "
249371|NCT00288405|"~     To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent~     System to facilitate endovascular coil embolization of wide neck saccular intracranial~     aneurysms.~      Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck,~     intracranial, saccular aneurysms arising from a parent vessel~   "
249372|NCT00288392|"~     The purpose of this study is to evaluate the efficacy of soluble beta-1,3/1,6-glucan compared~     to placebo on the healing of chronic leg ulcers in diabetes patients.~      Hypothesis: Through its ability to activate tissue macrophages and counteract~     diabetes-associated defects in macrophages, the soluble beta-1,3/1,6-glucan will promote the~     healing of leg ulcers in diabetic patients.~   "
249373|NCT00288379|"~     To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of~     formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of~     inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild~     asthma~   "
249374|NCT00288366|"~     The objective of this study is to determine the effect of various mood stabilizers (MS) on~     the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in~     patients treated with antipsychotic drugs (APDs). Patients will be switched from their~     current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless~     clinically contraindicated) for comparison with metabolic levels during treatment with the~     former medication.~      The metabolic syndrome is an empirical concept based on extensive evidence that a~     constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low~     HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of~     cancer.~   "
249375|NCT00288353|"~     The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG~     changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.~   "
249376|NCT00288340|"~     The goal of the project is to characterize abnormalities in brain structure and function~     related to schizophrenia. The investigators will use advanced magnetic resonance imaging~     (MRI) techniques to measure the degree and distribution of neuronal activity during specific~     cognitive tasks, alterations in neuronal connectivity, and how these are related to disease~     symptoms and treatment.~   "
249377|NCT00288327|"~     The overall aim of the study was to test the feasibility and effectiveness of a~     cardiovascular disease risk reduction intervention program for midlife, low-income women. We~     enhanced an existing nutrition and physical activity intervention tool, A New Leaf...Choices~     for Healthy Living, which was designed specifically for this demographic group as part of the~     CDC's WISEWOMAN Program. The enhanced intervention was tested in a randomized controlled~     trial in a community health center setting.~   "
249378|NCT00288314|"~     Neuropsychological studies investigating trauma-exposed and posttraumatic stress disorder~     (PTSD) subjects have generally underlined the significantly poorer performance of tasks that~     require attention, concentration, and verbal memory, and difficulty in regulating memories~     surrounding the traumatic event. A previous study (El Hage et al. Cognitive Neuropsychiatry,~     2006) revealed that the trauma-exposed subjects scored higher on anxiety/depression scales,~     and lower on processing speed tests. Moreover, the study showed significant impairment in~     working memory partially mediated by speed processing, but not by anxiety or depression.~     These results suggest that processing speed makes a major contribution to trauma-related~     working memory decline, and needs to be investigated in further studies.The aim of the~     present study is to explore correlation between hippocampus volume, frontal dysfunction and~     cognitive slowing in trauma-exposed subjects, while examining brain activation during~     performance of working memory tasks using functional magnetic resonance.~   "
249379|NCT00288301|"~     The purpose of this study is to test the effectiveness of a weight loss and weight loss~     maintenance intervention among low income women, conducted in a community health center~     setting.~   "
249380|NCT00288288|"~     The primary purpose of this study is to compare the time, risk and cost savings of 2 patient~     groups who receive FDA approved left ventricular pacing leads.~   "
249385|NCT00288223|"~     Study objectives:~        -  to document the clinical efficacy of telithromycin(800 mg per day for 5 days) at Test Of~          the Cure (TOC)visit (D12-D19), in acute exacerbation of chronic bronchitis.~        -  to assess the long-term clinical efficacy of telithromycin by telephone at D25-D35 (V3)~        -  to assess the safety of telithromycin~   "
249386|NCT00288210|"~     The incidence of stent restenosis in the setting of primary angioplasty is particularly high,~     reaching a rate of 27% In the last years the introduction of drug-eluting stents has~     drastically reduced the incidence of restenosis in patients not requiring urgent~     revascularization. Whether drug-eluting stenting might constitute the new optimal therapy for~     patients with an acute myocardial infarction is unknown. To be able to answer this question,~     we designed a randomized trial in which patients with an acute myocardial infarction eligible~     for treatment with primary angioplasty and abciximab were randomized to receive either a~     rapamicine-eluting stent or a conventional bare stent.~   "
249387|NCT00288197|"~     To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or~     probable deep tissue fungal infections.~   "
249388|NCT00288184|"~     The study is a randomized, double-blinded, placebo controlled, crossover trial of allopurinol~     for the treatment of children with newly diagnosed essential hypertension.~   "
249389|NCT00288171|"~     To test the hypothesis that lowering serum uric acid will ameliorate hypertension in children~     after renal transplantation.~   "
249390|NCT00288158|"~     The purpose of this study is to examine the consequences of lowering serum uric acid in~     pre-hypertensive, obese adolescents pathways involved with how uric acid mediated~     hypertension and renal disease. The specific aims are:~        1. Test the hypothesis that lowering uric acid will improve endothelial function.~        2. Test the hypothesis that lowering uric acid will reduce plasma renin activity and serum~          angiotensin II levels.~        3. Test the hypothesis that lowering uric acid will reduce markers of inflammation~   "
249391|NCT00288145|"~     The project is designed to test the effectiveness of a multilevel worksite wellness program,~     based in Rhode Island and nearby neighboring states to impact employee weight, dietary intake~     and physical activity, compared to an attention placebo condition.~   "
249392|NCT00288132|"~     The American Diabetes Association clinical care guidelines stress the importance of metabolic~     control to prevent complications and improve quality of life for persons with diabetes.~     Unfortunately, these guidelines have not had widespread acceptance into clinical practice.~     Therefore, we propose translational research to evaluate telemedicine technology using~     interactive video conferencing (Diabetes TeleCare) as a novel means to increase the~     availability of health professionals in rural communities for the effective delivery of a~     diabetes self-management education program and as a means to provide retinal screenings in~     the primary care setting.~   "
249393|NCT00288119|"~     This is a multi-center study whose aim is to define the epidemiology and genetics of~     Barrett's esophagus and adenocarcinoma. The researchers have studied families affected with~     Barrett's esophagus and esophageal adenocarcinoma, a specific type of cancer of the~     esophagus. They have found that Barrett's and esophageal cancer occur at a younger age in~     these families suggesting that familial Barrett's esophagus is a genetically inherited~     disease.~   "
249394|NCT00288106|"~     RATIONALE: Learning about the long-term effects of chemoprevention drugs, such as~     finasteride, in patients with prostate cancer may help doctors plan better treatment and~     follow-up care.~      PURPOSE: This clinical trial is following patients who were diagnosed with prostate cancer~     while undergoing treatment with either finasteride or a placebo on the Prostate Cancer~     Prevention Trial (PCPT).~   "
249395|NCT00288093|"~     This phase I trial is studying the side effects and best dose of 3-AP when given together~     with radiation therapy in treating patients with stage III pancreatic cancer that cannot be~     removed by surgery.~      3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP may make tumor~     cells more sensitive to radiation therapy. Giving 3-AP together with radiation therapy may~     kill more tumor cells.~   "
249396|NCT00288080|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using~     drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer~     by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays~     to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. It is not yet known whether giving hormone therapy and radiation therapy~     together with chemotherapy is more effective than giving hormone therapy together with~     radiation therapy in treating prostate cancer.~      PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy~     followed by docetaxel and prednisone to see how well it works compared to hormone therapy and~     radiation therapy in treating patients with localized prostate cancer.~   "
249397|NCT00288067|"~     This phase I/II trial is studying the side effects and best dose of fenretinide and to see~     how well it works when given together with rituximab in treating patients with B-cell~     non-Hodgkin lymphoma. Drugs used in chemotherapy, such as fenretinide, work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others~     interfere with the ability of cancer cells to grow and spread. Giving fenretinide together~     with rituximab may kill more cancer cells.~   "
249398|NCT00288054|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find~     tumor cells and kill them or carry tumor-killing substances to them. Others interfere with~     the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to~     kill tumor cells. Giving docetaxel and cetuximab together with radiation therapy may kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when~     given together with cetuximab and radiation therapy in treating patients with stage III~     non-small cell lung cancer.~   "
249399|NCT00288041|"~     This phase II trial is studying how well giving bortezomib together with paclitaxel and~     carboplatin works in treating patients with metastatic melanoma. Bortezomib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may~     help paclitaxel and carboplatin kill more tumor cells by making tumor cells more sensitive to~     these drugs~   "
249400|NCT00288028|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving bortezomib after an autologous peripheral blood stem cell~     transplant may stop the growth of any cancer cells that remain after transplant.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in~     treating patients with multiple myeloma who have undergone an autologous peripheral blood~     stem cell transplant.~   "
249401|NCT00288015|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with~     angiosarcoma.~   "
249402|NCT00288002|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, docetaxel, and~     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth~     in different ways. Some find tumor cells and kill them or carry tumor-killing substances to~     them. Others interfere with the ability of tumor cells to grow and spread. Giving combination~     chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed. Giving monoclonal antibodies~     after surgery may kill any tumor cells that remain after surgery. It is not yet known whether~     combination chemotherapy is more effective with or without capecitabine and/or trastuzumab in~     treating breast cancer.~      PURPOSE: This randomized phase III trial is studying epirubicin, cyclophosphamide, and~     docetaxel to compare how well they work with or without capecitabine and/or trastuzumab~     before surgery in treating women with stage I, stage II, or stage III breast cancer.~   "
249403|NCT00287989|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving erlotinib together with paclitaxel and carboplatin may~     kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when~     given together with paclitaxel and carboplatin to compare how well they work in treating~     patients with stage III, stage IV, or recurrent non-small cell lung cancer.~   "
249404|NCT00287976|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well irinotecan works in treating young patients~     with refractory or recurrent hepatoblastoma.~   "
249405|NCT00287963|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when~     given together with vinorelbine in treating patients with recurrent lung cancer.~   "
249406|NCT00287950|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~     Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain~     after surgery. Sometimes, the tumor may not need any treatment until it progresses. In this~     case, observation may be sufficient.~      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together~     with surgery and radiation therapy works in treating infants with neuroblastoma.~   "
249407|NCT00287937|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with paclitaxel and carboplatin in treating patients with advanced or refractory~     solid tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may~     kill more tumor cells~   "
249408|NCT00287924|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating~     young patients with residual ependymoma.~   "
249409|NCT00287911|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Internal radiation~     uses radioactive material placed directly into or near a tumor to kill tumor cells. Topotecan~     and cisplatin may make tumor cells more sensitive to radiation therapy. Giving topotecan and~     cisplatin together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when~     given together with cisplatin and radiation therapy in treating patients with advanced~     cervical cancer.~   "
249410|NCT00287898|"~     RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is~     not yet known whether genetic counseling by telephone is more effective than standard~     (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.~      PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to~     see how well it works compared to standard (in-person) genetic counseling in women at risk of~     carrying the BRCA1 or BRCA2 mutation.~   "
249411|NCT00287885|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving~     daily doses of docetaxel may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel in~     treating patients with refractory or recurrent advanced gynecologic cancer.~   "
249412|NCT00287872|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood~     flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide~     works in treating patients with newly diagnosed stage II or stage III multiple myeloma.~   "
249413|NCT00287859|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Chemotherapy drugs may have different effects in patients who have a poor performance status.~      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in~     treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or~     primary peritoneal cavity cancer with a poor performance status.~   "
249414|NCT00287846|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see~     how well it works in treating patients with recurrent or refractory aggressive fibromatosis.~   "
249415|NCT00287833|"~     This randomized phase I trial is studying the side effects and best dose of Bowman-Birk~     inhibitor concentrate in preventing cancer in healthy men. Chemoprevention is the use of~     certain drugs to keep cancer from forming, growing, or coming back. The use of Bowman-Birk~     inhibitor concentrate may prevent cancer.~   "
249416|NCT00287820|"~     The primary objective of the study is to assess whether chronic treatment with olanzapine~     over a five-month period produces a significant increase in abnormalities in glucose levels.~     The main secondary objective is to evaluate whether the increase in glucose levels and rate~     of glucose abnormalities differs between Olanzapine and Risperidone during this treatment~     period. Additional secondary objectives of the study are to investigate similar questions~     with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid~     metabolism.~      We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in~     the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin,~     insulin and lipids.~   "
249417|NCT00287807|"~     Self-monitoring of blood glucose (SMBG) is one of the important instruments in diabetes~     management. Most patients with type 1 diabetes and patients with type 2 using insulin,~     frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate~     the insulin treatment and get information about how to change the insulin regimen, if~     necessary. Without SMBG it is almost impossible to achieve this goal.~      The purpose of this study is to determine if self-monitoring in patients with type 2 diabetes~     not using insulin results in better glycemic control.~   "
249418|NCT00287794|"~     As one of the characteristic clinical features of the patients with rheumatoid arthritis, the~     unique character of the patients, somewhat difficult to be persuaded but theoretical, has~     long been pointed out. The investigators hypothesized that this unique character might be due~     to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique~     biochemical disease activities. The investigators test (1) the sleep quality of the patients~     and draw some characteristic features, and (2) investigated the connection between unique~     biochemical changes such as the increase of c-fos or wee-1.~   "
249419|NCT00287781|"~     Migraine headaches have previously been shown to be responsive to intranasal lidocaine in a~     small study. Using a nebulizer to administer the drug would improve the feasibility of using~     the treatment. It would also spare the patient narcotics with their attendant side effects.~     Because of the potential for placebo effect a placebo control is necessary in this study.~   "
249420|NCT00287768|"~     The primary objective of this study is to compare median overall survival of the test arm~     (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent~     gastric cancer.~   "
249421|NCT00287755|"~     To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant~     cancer chemotherapy after gastric surgery~   "
249422|NCT00287742|"~     The purpose of this study is to assess the effectiveness and safety of risperidone (an~     antipsychotic medication) versus placebo for the treatment of patients with hallucinations~     and delusions associated with Alzheimer's disease.~   "
249423|NCT00287729|"~     The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403~     milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis~     (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared~     with placebo in patients with idiopathic pulmonary fibrosis.~   "
249424|NCT00287716|"~     The objectives of this study are to assess the safety and efficacy of treatment with~     pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic~     pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone~     1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the~     pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.~   "
249425|NCT00287703|"~     About 30% of patients with major depression are treatment resistant to pharmacological~     treatment. In the search for new methods to treat depression a great interest has been put~     into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak~     electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields)~     can alleviate the symptoms of depression.~   "
249426|NCT00287690|"~     The aim of this study is to investigate the effect of genistein administration on coronary~     arteries in humans. We will measure the size of a coronary artery and the speed and amount of~     blood flow in response after subjects have ingested Supro® drinks (a soy protein drink~     containing genistein).~   "
249457|NCT00287287|"~     The primary objective of the study is to assess the anti-tumor activity of REVLIMID®~     (lenalidomide), administered as a single agent, in patients with distantly metastatic thyroid~     carcinomas which are unresponsive to systemic radioiodine, in terms of tumor response and~     response duration.~   "
249427|NCT00287677|"~     Concomitant administration of recombinant human growth hormone (rhGH) may boost the expansion~     of immune reconstitution and broaden specific T cell responses not achievable by vaccination~     alone. The main objective of that study is to test the validity of this hypothesis with~     vaccines which are routinely administered to HIV-1 patients(tetanus toxoid and hepatitis A~     virus vaccines) in order to, if proven of value, use this strategy of HIV vaccination in the~     near future. This is a pilot, randomized, clinical open label study aimed to investigate~     thymic functionality and the HIV-specific responses after administration of rhGH in HIV-1~     infected patients in highly active antiretroviral therapy (HAART) regimen.~   "
249428|NCT00287664|"~     Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of~     patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents~     (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous~     studies are pilot studies and they are not able to give information about an improvement in~     survival. This comparative randomized study was delineated to test the efficacy of~     terlipressin on survival.~   "
249429|NCT00287651|"~     Diabetic Retinopathy is the leading cause of blindness in the world. Previous studies have~     documented beneficial effects of physiologic administration of pulsatile insulin on a variety~     of diabetic complications such as nephropathy, hypertension, glycemic control, etc. Similar~     pathogenetic mechanisms have been postulated for diabetic retinal disease. This study~     examines the effect of pulsatile insulin on patients with varying stages of diabetic retinal~     disease.~   "
249430|NCT00287638|"~     Patients with obstructive sleep apnoea (OSA) have repetitive episodes of partial or complete~     upper airway obstruction during sleep. This leads to sleep fragmentation and symptoms like~     excessive daytime sleepiness and impaired psychosocial well-being. More evidence now~     suggested OSA is associated with cardiovascular diseases like hypertension, myocardial~     infarction, pulmonary hypertension and stroke.~      The upper airway structure and function are altered in OSA. Some studies suggested that an~     increase in the levels of systemic biomarkers of inflammation and oxidative stress in~     patients with OSA. So far, there is only very limited data on non-invasive monitoring of~     inflammation involved in the upper airway of OSA patients. The inflammatory mechanisms~     involved in the upper airway may give some insights to the systemic effect, like~     cardiovascular complications, of OSA.~      Measurement of the constituents of exhaled breath and exhaled breath condensate (EBC) is a~     non-invasive method to assess the degree of inflammation of the airway. Exhaled nitric oxide~     (eNO) can be measured with the subject exhaling to a mouthpiece connected to a machine~     measuring real-time eNO level. With the subject exhaling to a cooling unit, EBC can be~     collected as liquid is formed as a result of condensation.~      This study will assess the eNO in exhaled breath, oxidative stress marker (8-isoprostane) and~     cellular inflammatory markers (eotaxin, monocyted derived chemokine, growth related oncogene-~     alpha, monocyte chemoattractant protein-1) in the EBC and blood of OSA patients before and~     after 1 night and 3 months of continuous positive airway pressure treatment.~   "
249431|NCT00287625|"~     Chronic obstructive pulmonary disease (COPD) is a disease state characterized by airflow~     limitation that is not fully reversible. Acute exacerbation of COPD (AECOPD) with increasing~     symptoms like dyspnea, cough and sputum is the natural history of the disease and incurs~     significant burden to our health care system. In Hong Kong, COPD was the 5th leading cause of~     death, and accounted for at least 4% of all public hospital acute admissions in 2003.~     Previous studies have shown that pulmonary function and quality of life were adversely~     affected by frequent exacerbations. Strategies to decrease the heavy use of health care~     resources is urgently needed for the benefits of the patients and the society.~      Pulmonary rehabilitation programme (PRP) is a multidisciplinary programme of care for~     patients with chronic respiratory impairment. In COPD patients, the programme can be tailored~     individually and can optimize each patient's physical and social performance and autonomy.~     Previous studies on patients with stable COPD found that a PRP including education and~     physical training could lead to statistically significant and clinically meaningful~     improvements in health related quality of life and exercise capacity.~      COPD patients who just have experienced an episode of acute exacerbations are at high risk of~     developing another attack. There has been only one randomized controlled study looking at the~     effect of out-patient PRP for patients immediately after an exacerbation. It has shown that~     PRP immediately after an exacerbation was safe and improved the exercise capacity and the~     quality of life at 3 months. However, the follow up duration of the study was short and thus~     the effect of rehabilitation on recurrent exacerbations and hospitalizations is not assessed~     and this information is important.~      The investigators would thus like perform a randomized controlled trial to assess if a short~     course (for 6 weeks) out-patient PRP for patients admitted to acute hospital for AECOPD could~     have a positive impact on the patients by decreasing their health care resources utilization~     (recurrent COPD exacerbations, hospitalizations and accident and emergency department [AED]~     attendance) and improving the quality of life of the patients over a period of 1 year.~     Patients will be randomized to either a control group or PRP intervention group.~      It is hope that the information generated from this study will be able to give a guide to~     whether short course PRP is effective for the patient (in terms of quality of life) and the~     health care system (in terms of health care utilization).~   "
249432|NCT00287612|"~     This study compares complete dissection of the tissue around the lower esophagus to no~     dissection of these tissues during laparoscopic fundoplication in children.~   "
249433|NCT00287599|"~     The military is subject to traumatic wounds of various types and severity. Such wounds are~     predisposed to infection because they 1) tend to be extensive and deep, 2) may affect areas~     of normal carriage of potentially pathogenic bacteria in the gastrointestinal tract, upper~     respiratory tract, and the female genital tract, 3) typically produce tissue damage, 4) may~     introduce foreign bodies, 5) may interfere with local blood supply, 6) tend to produce~     ischemia, edema and hemorrhage, 7) may be complicated by fractures or burns and 8) may lead~     to shock and overwhelming of the body's systemic defenses. It will not always be possible in~     the military setting to cleanse and debride the wound promptly and effectively or to promptly~     provide surgery in the event of damage to vital structures. In the active military setting,~     the probability of wound infection following trauma is relatively high. In the absence of~     rapid identification of infecting flora and provision of information on antimicrobial~     susceptibility, clinicians must resort to empiric therapy rather than a tailored therapy.~     There is a tendency to use one of the top available agents that would likely be active~     against the vast majority of bacteria. This leads to increases in antimicrobial resistance,~     an important problem.~      The investigators hypothesize that the use of molecular biology techniques will provide~     identification of the microorganisms responsible for wound infection more rapidly and~     accurately. The investigators will evaluate real-time PCR (polymerase chain reaction)~     technique under this proposal. This procedure can be applied directly to material from the~     wound without need for first growing the organisms. It can be used to define the total flora~     of the wound within five hours. The investigators will first develop primers and probes that~     will detect the various bacteria anticipated in a given wound in a certain location. These~     primers and probes will be used in real-time PCR for rapid and accurate identification of the~     wound flora. The information obtained with real-time PCR is quantitative so that one may~     judge the relative importance of different isolates. The investigators will also use another~     molecular approach, 16S rRNA gene cloning, and conventional cultures; these will provide~     further information about the flora of various wounds. Definitive identification of anaerobes~     can be provided quickly and that, along with information on usual antimicrobial~     susceptibility patterns, can be life-saving or shorten the course of the infection~     considerably.~   "
249458|NCT00287274|"~     Device: computerized physician order entry.~      We wanted to investigate if the introduction of a computerized intensive care unit system~     reduced the incidence and severity of medication prescription errors (MPEs). A prospective~     trial was conducted during 5 weeks in a paper-based unit versus a computerized unit. The~     registration of different classes of MPEs was done by a clinical pharmacist. An independent~     panel evaluated the severity of MPEs.~   "
249434|NCT00287586|"~     As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of~     age or older, have low testosterone levels. It is known that short-term testosterone~     replacement is safe, and can increase muscle strength and physical function, but the risks of~     long-term testosterone replacement in older men with low testosterone levels are incompletely~     understood.~      Atherosclerosis is characterized by thickening of the artery walls, and the narrowing of the~     blood vessels as cholesterol is deposited in the lining of the arteries. It is the major~     cause of cardiovascular disease including ischemic heart disease (heart attacks) and stroke.~     Although, historically, there has been a widespread perception that higher levels of~     testosterone might increase the risk of atherosclerosis, the evidence from research does not~     support this. In observational studies, higher testosterone levels have been correlated with~     more favorable cardiovascular risk factors, and supplementation with testosterone to bring~     older men into the normal range for healthy younger men appears to improve several~     cardiovascular risk factors, and may slow the progression of atherosclerosis.~      The primary purpose of this study is to look at the effects of testosterone replacement on~     the progression of atherosclerosis in older men. This study is also being done to find out~     whether replacement with testosterone in older men with low testosterone levels improves~     their health-related quality of life.~   "
249435|NCT00287573|"~     The objective of this study is to evaluate the safety and effectiveness of the TAXUS Express2~     Paclitaxel-Eluting Coronary Stent System as compared to brachytherapy in patients~     experiencing in-stent restenosis.~   "
249436|NCT00287560|"~     The purpose of the study is to determine wether a modified propofol preparation shows any~     effect on the incidence of injection pain in children undergoing elective surgery under~     general anesthesia.~      Study hypothesis: The use of a modified propofol preparation will reduce the incidence of~     injection pain in the study group.~   "
249437|NCT00287547|"~     The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and~     immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris~   "
249438|NCT00287534|"~     The purpose of this study is to determine the efficacy and tolerability of 3 years treatment~     with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment~     with tamoxifen in postmenopausal women with early breast cancer~   "
249439|NCT00287521|"~     The purpose of this study is to determine whether a glaucoma therapy is safe and effective in~     treating patients with open-angle glaucoma or ocular hypertension.~   "
249440|NCT00287508|"~     To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield®~     BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange~     Carotid Stent System when used under commercial use conditions by a broad group of physicians~     entering the study with differing carotid artery stenting experiences.~   "
249441|NCT00287495|"~     Background:~        -  Kaposi's sarcoma (KS) is a disease in which cancer cells are found in the tissues under~          the skin or mucous membranes that line the mouth, nose, and anus. KS causes red or~          purple patches (lesions) on the skin or mucous membranes and spreads to other organs in~          the body, such as the lungs, liver, or intestinal tract.~        -  BAY 43-9006 inhibits the activity of several proteins or protein receptors in cells that~          are thought to be important to the progression of KS. Blocking these mechanisms may~          cause KS to get better.~      Objectives:~        -  To learn about the toxicity and blood levels of BAY 43-9006 in people with KS who are~          and are not taking the anti-retroviral drug ritonavir.~        -  To look for evidence of a beneficial treatment effect of BAY 43-9006~      Eligibility:~        -  Adults with confirmed KS, both HIV-positive and HIV-negative.~        -  Patients must have either 1) at least five measurable KS lesions with no previous local~          therapy, or 2) other measurable non-skin disease that permits evaluation of a response~          to treatment.~      Design:~        -  Patients are randomly assigned to a specific dose of BAY 43-9006. They take the drug by~          mouth either once or twice daily, depending on their dose group, for up to 54 weeks.~        -  Drug blood levels are determined after patients have been taking BAY 43-9006 for 1 to 2~          weeks by blood collections immediately before the dose and at 1, 2, 4, 8, 12, 16 and 24~          hours after the dose.~        -  Patients are evaluated every 3 weeks with review of a medication diary, interview about~          drug side effects, physical examination, and assessment of KS lesions.~        -  KS lesions are photographed on entering the study and at other time points during the~          study.~        -  CD4 cell counts and HIV viral load are tested every 12 weeks.~        -  Biopsies are done at the start of the study, on day 15, and if it appears that all of~          the lesions have resolved.~        -  Other procedures, such as CT or MRI scans, may be done if medically indicated.~   "
249442|NCT00287482|"~     This is a pilot feasibility study being performed in women completing front-line treatment~     for breast or ovarian cancer. It is being done to evaluate whether or not an herbal~     combination known as Essiac (ESIAK) can improve the overall quality of life in these women as~     they transition from active treatment to follow-up, also known as the quality of life in~     transition. This information will be used to design a larger randomized trial.~   "
249443|NCT00287469|"~     The purpose of this study is to determine if a hepatitis E vaccine is safe and able to~     prevent symptomatic liver disease due to the hepatitis E virus.~   "
249444|NCT00287456|"~     We hypothesize use of the insulin pump will improve body weight, lean body mass, whole body~     protein turnover, hepatic glucose production (HGP), and blood sugar control in CF patients~     with impaired glucose tolerance or patients with CF related diabetes (CFRD). We further~     hypothesize that HGP is also elevated in children/adolescents with type 1 diabetes and that~     the insulin pump will result in decreased HGP.~   "
249445|NCT00287443|"~     Our specific aims include:~        1. AIM 1. Characterization of glucose tolerance, nutritional and clinical status,~          socioeconomic status, family history of diabetes and genotype in Hispanic CF children~          compared to Caucasian CF children. Each child will undergo a two-hour oral glucose~          tolerance test and will be categorized by glucose tolerance according to standards set~          forth by the 1998 CF Consensus Conference on Diabetes. Nutritional status will be~          determined by three-day food journals and intake will be compared to energy needs~          measured by indirect calorimetry. Socio-economic status will be calculated from reported~          family income and medical insurance coverage. Genotyping will be done at the laboratory~          of Dr. Arthur Beaudet at Baylor College of Medicine. Clinical status will be measured~          using modified NIH scores. Family history for both type 1 and type 2 diabetes will be~          obtained in Spanish by Dr.Vanderwel. This specific aim tests the hypothesis that glucose~          intolerance /frank CF related diabetes occurs at a younger age in Hispanics than in~          Caucasians with CF, and is correlated to family history of diabetes and clinical status.~        2. AIM 2. Characterization of insulin secretion and insulin sensitivity. Previous studies~          in adults have described peripheral insulin resistance as a major cause of CF related~          diabetes, yet studies have not been conducted in children. Studies in adults and~          children without CF suggest that insulin resistance occurs more frequently in Hispanics.~          We will measure insulin secretion and insulin sensitivity using the frequently sampled~          intravenous glucose tolerance test (IVGTT) and the minimal model analysis of Bergman, as~          modified for children. This specific aim tests the hypothesis that Hispanic children~          with CF have worse peripheral insulin resistance, but similar insulin secretion when~          compared to Caucasian children with CF.~        3. AIM 3. Quantification of post-absorptive gluconeogenesis and whole body protein~          turnover. Total hepatic glucose production (HGP) will be measured using~          [6,6-2H2]glucose. We will quantify gluconeogenesis by measurement of the incorporation~          of 2H into the 2nd, 5th and 6th carbons of glucose following 2H20 administration method~          of Landau). We will determine whole body protein turnover using the stable isotopes~          [1-13C]leucine and will measure serum amino acid levels. This specific aim tests the~          hypothesis that gluconeogenesis and whole body protein turnover are disproportionately~          higher in Hispanic children and adolescents with CF than in Caucasian CF children.~   "
249446|NCT00287430|"~     We hypothesize that the anabolic effects of growth hormone (GH) will improve the clinical~     status of patients with CF by improving lean body mass, osteopenia, muscle strength,~     pulmonary function, and quality of life.~      We will recruit 40 malnourished CF patients for this 12-month study. All 40 patients will be~     treated with recombinant human growth hormone (rhGH). Each patient will serve as his/her own~     control by obtaining medical records for 6 months to 1 year prior to study enrollment or by~     completing 6 months of study without GH prior to being treated for 1 yr. with GH.~   "
249447|NCT00287417|"~     The aim of the study is to evaluate the risk of Down syndrome during the first trimester of~     the pregnancy. The risk assessment is evaluated using early ultrasound and maternal~     biochemical markers.~   "
249448|NCT00287404|"~     Many patients with type 2 diabetes have difficulty attaining cholesterol goals, partly due to~     the recommendations for fasting measurements that may not be practical in the typical~     clinical setting. Focus toward therapy is shifting toward non-fasting assessments but little~     is known about the usefulness of this approach in diabetes, where postmeal cholesterol levels~     are more abnormal. This is an observational study examining fasting and postmeal lipids~     (cholesterol) in patients with type 2 diabetes using standard means and NMR.~   "
249449|NCT00287391|"~     This study will investigate Gastroesophageal Reflux Disease (GERD)as a cause of sleep~     disturbance. Patients with GERD may experience all or some of the following symptoms: stomach~     acid or partially digested food re-entering the esophagus (which is sometimes referred to as~     heartburn or regurgitation) and belching. Even very small, unnoticeable amounts of rising~     stomach acid may cause patients to wake up during the night.~      This study will also investigate the effect of Rabeprazole, (brand name Aciphex) on patients~     with known insomnia. Rabeprazole is an FDA approved medication already marketed for the~     treatment of GERD.~   "
249450|NCT00287378|"~     Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However,~     in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic~     allergic response, known as IgE-induced airway inflammation is what causes the increased~     inflammation in response to ozone. To do this we will examine the response to ozone in a~     group of asthmatics treated with omalizumab, a medicine available and approved for use in~     people with asthma, or a placebo control. The placebo for this study is inert physiologic~     saline (salt water) which contains no omalizumab. Both the omalizumab and the placebo will~     be administered as an injection under the skin. Omalizumab, also called Xolair, is a~     humanized monoclonal antibody, which means that it originally was produced in mice, then~     genetically engineered to look more like human than mouse antibody. Omalizumab inactivates~     IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this~     study is to test the hypothesis that omalizumab, by blocking this aspect of allergic~     reactions, will decrease the number of inflammatory cells in the airway after ozone~     challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes~     in lung function, mucociliary clearance (a measure of how quickly mucus clears form the~     airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways~     are to a medication used to diagnose asthma, called methacholine. We will examine these as~     additional information we can learn during the course of the study. This is a blinded study,~     meaning that neither you nor the researchers know if you get the active drug or placebo, but~     that information can be obtained if needed. The placebo is an injection of inert~     physiological saline (salt water) which contains no omalizumab.~   "
249451|NCT00287365|"~     Recent reports have shown that people with asthma who have a particular gene, known as the~     GSTM1 null gene, are more susceptible to the effect of air pollutants. The purpose of this~     research study is to learn if volunteers who have asthma and have a GSTM1 null gene have~     increased response (change in lung function and increase in lung cells collected from sputum)~     compared to volunteers with asthma who have the GSTM1 sufficient gene when challenged with~     0.4 ppm ozone during intermittent exercise. The principal purpose of this study is to~     identify hyper-responsive, responsive and non-responsive groups of human subjects with mild~     asthma based on their airway neutrophilic response to ozone exposure, and to perform analyses~     on DNA from airway cells to explore possible differences in genetic profiles between the~     three groups. An additional pilot aim is to compare expression of a small number of specific~     genes of interest in a subset of ozone-responsive and ozone-non-responsive subjects with mild~     asthma.~   "
249452|NCT00287352|"~     Weight gain associated with antipsychotic medication use is a major side effect that limits~     the tolerability of these drugs. This often significant weight gain adversely affects health,~     increasing risks for developing cardiovascular disease, diabetes, sleep apnea, cancers of the~     colon, kidneys, uterus, endometrium and esophagus and osteoarthritis. Beasley and colleagues~     (1997) reported that 40.5% of olanzapine-treated patients gained more than 7% of baseline~     weight. Much of the olanzapine induced weight gain occurs early in treatment, and~     antipsychotic-naïve and young patients (Woods et al., 2002) are particularly vulnerable to~     this side effect. One of the most promising medications to aid weight loss in patients taking~     olanzapine is amantadine.~      Attempts at preventing weight gain are expected to be more successful than attempts to~     reverse it once it occurs. It is now common clinical practice to educate all patients~     beginning treatment with olanzapine, and other antipsychotics, about healthy eating and the~     need for exercise. However, despite this effort, weight gain in this population continues.~     Beginning a weight-stabilizing medication after a low threshold of weight gain has occurred~     may have significant impact on patients' health and their willingness to continue to take~     antipsychotics.~      We propose to investigate the efficacy of amantadine as a weight-stabilizing agent in a~     population of first-episode psychotic subjects just beginning treatment with antipsychotic~     agents. This population is generally young and medically healthy, without contraindications~     to amantadine. They are often of normal body mass index and without obesity-related medical~     problems. They have much to gain in preventing the weight gain which so often progresses~     steadily over the course of treatment, is difficult to reverse and results in significant~     morbidity and mortality. Additionally, the first episode psychotic population tends to take~     fewer concomitant psychiatric medications. This is important since these medications may~     cause weight gain (long term use of mirtazapine, lithium, depakote) or weight loss (short~     term use of SSRI's) which could confound the effectiveness of amantadine to combat weight~     gain.~   "
249453|NCT00287339|"~     The purpose of this research study is to investigate different doses of proton pump~     inhibitors in reducing cough symptoms felt to be associated with Gastroesophageal reflux~     disease (GERD). Proton pump inhibitors are medicines used to treat GERD, which work by~     lowering the amount of acid in the stomach.~      The proton pump inhibitor used in this study is called, Esomeprazole (brand name Nexium), and~     is already marketed for treating GERD. Patients with GERD may experience all or some of the~     following symptoms: stomach acid or partially digested food re-entering the esophagus (which~     is sometimes referred to as heartburn or regurgitation), belching and coughing. Even very~     small, unnoticeable amounts of rising stomach acid may cause patients to cough.~      Because there may be a link between chronic cough and GERD, study doctors are interested in~     learning if giving high-dose Nexium (40 milligrams, twice daily) will help in treating~     chronic cough.~   "
249454|NCT00287326|"~     The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic~     will result in lower parenteral narcotic usage, and improved side-effect profile for~     post-operative pain in the pediatric population undergoing lower extremity or pelvic~     osteotomy.~   "
249455|NCT00287313|"~     The purpose of this study is to determine if daily Vitamin K supplementation stabilizes INRs~     in patients taking warfarin with a history of frequent dose changes or variable INRs.~   "
249460|NCT00287248|"~     This research is designed to obtain efficacy and safety information for 123-I IMPY as an~     imaging biomarker for Alzheimer's disease (AD). The distribution of this agent will be~     measured by obtaining single photon emission computed tomography (SPECT) images of the brain~     serially over time to determine the relative localization of the radiopharmaceutical in~     regions of the cortex relative to background regions and develop an optimal technique of~     radiotracer administration (bolus or bolus with constant infusion). The researchers will then~     evaluate the utility of 123-I IMPY and SPECT in AD patients as an early diagnostic tool and~     subsequently serial evaluations of AD patients will be performed to determine if this~     technique may be useful as a tool for evaluation of progressive brain β-amyloid deposition in~     AD.~   "
249461|NCT00287235|"~     The primary objective of the study was to compare the efficacy, safety and tolerability of~     Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System~     (MARS®) device in improving severe HE by 2 grades compared to Standard Medical Therapy (SMT)~     in patients with chronic End Stage Liver Disease (ESLD) during a 5 day study period.~   "
249462|NCT00287222|"~     The primary efficacy endpoint will be the proportion of subjects that remain free of~     progression at the 27th week following the onset of treatment. Secondary objectives include~     the subject's time in weeks from treatment onset to documented disease progression as~     assessed by the RECIST criteria, response rate, median and overall survival, safety and~     tolerability.~   "
249463|NCT00287209|"~     The purpose of this study is to determine whether postoperatively oral treatment with high~     dosis amiodarone for five days after intravenously admitted bolusinfusion will minimize the~     risk for development of atrial fibrillation after coronary artery bypass grafting.~   "
249464|NCT00287196|"~     This trial seeks to establish the role of post-operative radiotherapy in patients who have~     had surgery for melanoma involving lymph nodes and who are at high risk of recurrence.~   "
249465|NCT00287183|"~     Current research indicates that TTP488 may be a viable agent for the treatment of diabetic~     nephropathy. The purpose of this study is to determine the safety and efficacy of a six-month~     regimen of daily orally-administered TTP488 to patients with diabetic nephropathy.~   "
249466|NCT00287170|"~     The study is being undertaken to evaluate whether delayed-release medications, designed to~     begin to open in the lower intestinal tract, the main site of Crohn's Disease, are more~     effective than standard systemically delivered drugs to promote remission or response in CD~     patients. It is hypothesized that the delayed-release medications will go right to the~     injured tissue and heal the disease more quickly.~      The delayed-release test drugs are 6-mercaptopurine (at a dose of 40 mg daily) or calcitriol~     (at a dose of 5 mcg three times a week) versus Purinethol (6-MP at a dose of 1-2 mg/kg body~     weight daily). Calcitriol is a synthetically manufactured replica of a natural substance in~     the body that is derived from Vitamin D. There is much medical evidence that shows that lack~     of Vitamin D can be a possible risk factor in developing autoimmune disorders, including~     Crohn's Disease. Moreover, calcitriol has been shown in animal models to improve the symptoms~     of Crohn's Disease.~   "
249467|NCT00287157|"~     Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine,~     a known anti-spasticity medication, has been shown in a previous study to improve sleep and~     next-day functioning in CP (cerebral palsy) patients. It is hypothesized that this~     improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with~     resulting improvement in quality-of-life (i.e.,improvements in next-day functioning,~     cognition and movement) may also be seen in a similar patient population, i.e., children with~     traumatic brain injury (TBI).~   "
249468|NCT00287144|"~     The study tries to determine if post partum thyroiditis has marked long term (20 years after~     partum) risk for developing hypothyroidism.~   "
249469|NCT00287131|"~     Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate~     of patients with metastatic disease is less than 5% with a median survival of only 6-10~     months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other~     chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually~     short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more~     promising results. This form of therapy has a similar response rate with some patients~     achieving a durable complete response. Recently the National Institute of Health (NIH)~     reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of~     large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective~     regression was achieved in 51% of patients with metastatic melanoma.~      Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in~     Israel.~   "
249470|NCT00287118|"~     An open-label, multi-center study to establish psoriasis control of moderate to severe plaque~     psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.~   "
249471|NCT00287105|"~     The purpose of this study is to determine whether Imatinib is safe and effective in~     association with intensive treatment of Ph+ALL in children.~   "
249472|NCT00287092|"~     Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active~     immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive~     infections caused by Haemophilus influenzae type b. However there are currently no clinical~     data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule.~     This study is designed to provide safety and immunogenicity data to support the use of~     Pediacel™ according to a 3, 5, and 12 months schedule.~   "
249473|NCT00287079|"~     The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc)~     interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to~     Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second~     exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome (CIS)~     accompanied by an abnormal magnetic resonance imaging (MRI). The secondary objectives are to:~        -  Assess the effectiveness of sc IFN beta - 1a (Rebif®) therapy in reducing the proportion~          of patients with CIS converting to CDMS~        -  Assess the safety of sc IFN beta - 1a (Rebif®) in the patients with CIS~   "
249474|NCT00287066|"~     To assess the impact of inhalation of insulin on glucose disposition in patients with type 1~     diabetes~   "
249793|NCT00282828|"~     This study will compare the effectiveness of either adding clonazepam or placebo to standard~     treatment or switching to venlafaxine in treating generalized social anxiety disorder in~     individuals who have not responded to treatment with sertraline.~   "
249475|NCT00287053|"~     The purpose of the proposed study is to identify the mechanisms responsible for the weight~     gain associated with Depakote treatment, and to identify methods to prevent and treat weight~     gain in people taking Depakote. Both sides of the energy balance equation will be measured in~     a sample of healthy lean and overweight adults. Energy intake will be measured in the~     Pennington Center's Eating Laboratory, and total daily energy expenditure (TEE) and posture~     allocation will be measured with the IDEEA™. Questionnaires that assess food cravings and~     eating attitudes and behaviors will be used to determine if a behavioral phenotype is~     associated with weight gain in response to Depakote treatment. It is hypothesized that~     Depakote treatment will result in increased food intake. It is also hypothesized that the~     time spent engaging in sedentary behavior will increase in response to Depakote treatment.~     Time spent engaging in, and the energy expended during, physical activity is expected to~     decrease significantly. Therefore, it is hypothesized that TEE is expected to decrease~     significantly. The results will be used to identify specific behavioral targets to prevent~     weight gain during treatment with Depakote. Potential targets include interventions to modify~     food intake and physical activity. The degree to which each behavior (food intake or physical~     activity) will be targeted is dependent on the results of this study. For instance, if the~     majority of the weight gain associated with Depakote treatment is due to changes in food~     intake, stronger dietary interventions will be suggested. Additionally, changes in endocrine~     factors (hormones and peptides) will be evaluated during the study to determine if Depakote~     is associated with an altered endocrine response that affects satiety, food intake, or energy~     expenditure. If an altered endocrine response is found, these results will be used to~     identify adjunctive medications or compounds to correct the endocrine response and reduce~     weight gain. Genomic studies will also be possible, since gene sequencing and gene expression~     can be analyzed from archived buffy coat samples.~   "
249476|NCT00287040|"~     The purpose of this study is to compare mammography adherence among women receiving tailored,~     interactive mammography interventions via DVD and telephone counseling to usual care.~   "
249477|NCT00287027|"~     Patients who have schizophrenia, schizoaffective disorder, a psychotic disorder, and are~     being treated with a medication called Risperidone Long Acting Injectable medication or~     another antipsychotic medication are candidates for the study. The purpose of the study is to~     find out from patients' family how they feel the medication has affected their relationship~     with them. The study will involve meeting with family members three times over the course of~     one year. The first time will be at New Hampshire Hospital (NHH) or at a community mental~     health center and the follow up times will be at a convenient place and time for the family~     member (s), in the community. We will ask them to answer questions from the Family Burden~     Interview and Quality of Life Questionnaire. The family will not be charged for any test that~     is completed solely for this study. The family will be provided a travel stipend to meet with~     the researchers.~   "
249478|NCT00287014|"~     The purpose of this study is to find out how, why, and when Rift Valley Fever (RVF) spreads.~     Participants will be 250 adults and children, aged 1 year and older, from the Ijara District,~     Kenya. They will be given a questionnaire, undergo a medical examination that includes an eye~     exam, and have a 1-teaspoon sample of blood taken from a vein. Participation will take about~     3 hours.~   "
249479|NCT00287001|"~     - To investigate the benefit of epidermal cooling on the incidence of post inflammatory~     hyperpigmentation after laser irradiation~   "
249480|NCT00286988|"~     The purpose of this study is to assess the effectiveness, tolerability and safety of oral~     topiramate for the preventative management of Cyclic Vomiting Syndrome. It is believed that~     topiramate will decrease the frequency, duration and severity of attacks experienced by~     children and adolescents with Cyclic Vomiting Syndrome.~   "
249481|NCT00286975|"~     Study objective: The objective of this trial was to determine the effectiveness of a~     Leadership Development Program (LDP) aimed at 1) establishing basic management knowledge and~     2) promoting reflection of leadership skills.~      Study design: Randomized, controlled, single-blind trial. Study participants: Senior~     postgraduate medical and surgical trainees at an urban university health care centre.~      Methods: Eligible participants were randomized to either the LDP(intervention group) or to~     regular postgraduate training (control group). For ethical reasons, all participants assigned~     to the control group were offered the LDP at the end of the trial. The 1º outcome measure~     used was a knowledge-based written exam. The sample size was estimated on finding a 20%~     difference in mean test scores between groups. Participants' reflective capacity and higher~     order leadership role skills were tested through a personal learning project (PLP, 2º outcome~     measure).~   "
249482|NCT00286962|"~     The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous~     administration of insulin regarding safety, glycemic control and number of episodes of~     hypoglycemia in patients with type 1 diabetes mellitus.~   "
249483|NCT00286949|"~     Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention~     deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance~     levels of brain chemicals that may be affected in people with executive dysfunction,~     (difficulties with organization, task completion, and priority setting). Thus, atomoxetine~     has the potential to improve executive dysfunction in people with Parkinson's disease (PD).~      The goal of this study is to provide preliminary data on the effectiveness and tolerability~     of atomoxetine for the treatment of executive dysfunction in patients with PD.~   "
249484|NCT00286936|"~     To examine the influence of regular hypnotic therapy on the incidence of delirium after hip~     fracture surgery~   "
249485|NCT00286923|"~     The purpose of the study is to determine by the use of non-invasive magnetic stimulation if~     the medication Topiramate adjusts the excitability of the migraine sufferer's brain.~      Previous studies have shown the migraine sufferer's brain is more excitable. The magnetic~     stimulation device has given us a way to look at excitability and to see if it changes at the~     same time that a headache diary shows if the pattern or severity of headaches changes with~     the administration of the drug Topiramate.~      It is expected that as migraine sufferers have fewer headaches with topiramate the testing~     with magnetic stimulation will show that their brains are less excitable and that if the~     topiramate does not change the character of headaches then the pattern of excitabilty would~     not change from the baseline test before medication is started.~   "
249486|NCT00286910|"~     We want to test the hypothesises that patients with nephrotic syndrome have a higher~     excretion of AQP2 in the urine,that they have a higher concentration of AVP,and a lower~     C-H2O.Everything will normalize, when the syndrome is in remission.Furthermore we want to~     test the hypothesis that the expression of mutations in the NPHS2-gene,that codes for~     podocin,will cause a lack off or a poorer response in the treatment of nephrotic syndrome~   "
249498|NCT00286754|"~     The purpose of this study is to determine whether a stage-matched intervention (SMI) will~     lower BP and improve treatment adherence compared to usual care (UC) or a health education~     intervention (HEI) in veterans with uncontrolled BP. The study will also examine the effect~     of SMI on patient's health-related quality of life, satisfaction, acceptability and determine~     its cost-effectiveness.~   "
249487|NCT00286897|"~     Patients will be randomised to receive either placebo or the study drug for a period of 30~     weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the~     patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder~     of the 22 weeks, all medications should be kept stable. Patients will be required to attend~     the clinic twice during the screening period and then a further 8 times during the treatment~     period. They will be required to complete home diaries where they will record their motor~     function. In addition, their doctor will assess their Parkinson's disease during the clinic~     visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics~     evaluation. Following the treatment and assessment period, they will return to the clinic one~     month later for follow up.~   "
249488|NCT00286884|"~     The aim of the study is to investigate heart rate variability in patients with white coat~     hypertension and patients with essential hypertension.~   "
249489|NCT00286871|"~     Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help~     prevent post-transplant rejection.~   "
249490|NCT00286858|"~     This study shall evaluate in daily medical practice the clinical results of the AV delay~     hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for~     one of the three following indications: sinus node dysfunction, atrial disease (or~     bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome~     of automatic functions will be evaluated.~   "
249491|NCT00286845|"~     A previous preliminary study performed at Vanderbilt University with funding from the~     Leukemia Society of America demonstrated that the response of leukemia cells in vitro to the~     chemotherapeutic agent idarubicin in the microculture kinetic assay for apoptosis (MiCK~     assay) predicted survival in patients with newly diagnosed acute myeloid leukemia (AML). In~     this previous study, achievement of complete response (CR) to induction therapy with~     idarubicin and cytarabine was used as the clinical indicator for determining whether leukemia~     specimens taken prior to treatment were sensitive or not sensitive in the MiCK assay. This~     group of patients has been followed for 7 years and their long term survival rates show that~     their responses in the MiCK assay to idarubicin but not cytarabine predict survival. In the~     present proposal a separate group of patients with newly diagnosed AML will be recruited to~     provide leukemia cell samples that will be used to establish criteria for sensitivity and~     non-sensitivity to idarubicin and cytarabine in the MiCK assay. The achievement of CR will be~     used to determine in vitro sensitivity as it was done in the previous study. With the in~     vitro sensitivities as determined in this proposed study, the long term survivals of patients~     in the previous study will be analyzed prospectively.~      The proposed study is expected to have an approximate duration of one year. Patient~     population will include newly diagnosed AML patients with both de novo AML and AML arising~     from a previously diagnosed myelodysplastic syndrome. The study will not include patients~     with previously treated leukemia that has relapsed~   "
249492|NCT00286832|"~     Early identification of refractory lymphoma patients provides a basis for stratification~     between responders to standard approaches and non-responders who may benefit from an early~     change to an alternative treatment strategy.Metabolic or molecular imaging with fluorine-18~     fluorodeoxyglucose positron emission tomography (18F-FDG-PET) has emerged as a powerful~     imaging modality for diagnosis, staging, and therapy monitoring of a variety of cancers. The~     primary hypothesis of the present study is that early response can be pinpointed by PET~     reflecting both tumor burden and activity, as a surrogate for final outcome. An increasing~     number of studies have suggested the potential role of 18F-FDG PET in the staging and~     monitoring of lymphomas. The optimal timing of PET scans and the potential role of~     quantitative PET using SUV to assess response to chemotherapy remain to be defined.~     Confirmation of very early 18F-FDG-PET as a significant predictor of treatment response in a~     homogenous group of aggressive lymphoma patients would potentially change the prognosis of~     the patient by allowing earlier use of alternative therapies and discontinuation of therapy~     that will not lead to a significant tumour response.~   "
249493|NCT00286819|"~     This is an open -label randomized phase II study of dose-dense~     Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2~     (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.~   "
249494|NCT00286806|"~     This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of~     single-agent AT-101 in men with hormone-refractory prostate cancer.~   "
249495|NCT00286793|"~     This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of~     AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate~     cancer that are either chemotherapy naive or have received and progressed on a docetaxel~     containing regimen,~   "
249496|NCT00286780|"~     This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in~     combination with rituximab in patients with relapsed or refractory chronic lymphocytic~     leukemia.~   "
249497|NCT00286767|"~     This study will investigate what factors may lead to the development of immune reconstitution~     syndrome (IRIS) in HIV-infected patients and what the outcome is after IRIS. It will also~     seek to better define and describe the syndrome. IRIS is a condition that can occur in~     HIV-infected people following the start of antiretroviral therapy. The sudden improvement of~     immune function with this therapy can cause an unexpected worsening of diseases the patient~     already has, such as tuberculosis or fungal infections, and development of fever, enlarged~     lymph nodes or other complications, or even uncover a previously silent disease.~      HIV-infected people who are at least 18 years old, whose CD4+T cell count is 100 cells per~     microliter or less, and who have not previously been treated with combination antiretroviral~     therapy or have taken the drugs for less than 3 months and more than 6 months before~     screening for this study may be eligible to participate. Candindates must also live within~     the wider DC area so that acute problems after therapy initiation will be evaluated at NIH.~     Candidates are evaluated before starting therapy with a medical history and physical~     examination, blood and urine tests, electrocardiogram, chest x-ray and CT scan of the chest,~     tuberculin skin testing, apheresis, and possibly an intestinal (gut) and lymph node biopsy~     (surgical removal of a small piece of tissue for microscopic examination). For apheresis,~     blood is collected through a needle in an arm vein and spun in a machine that separates the~     blood components. The white blood cells and plasma are removed, and the red cells and~     platelets are returned through the same needle or through a needle in a vein in the other~     arm.~      Participants have a complete history and physical examination and additional blood tests,~     including genetic studies, upon entering the study. They start taking anti-HIV medications,~     prescribed according to the current standard of care, as well as medications to treat other~     infections, and treatment of IRIS, if needed. The study lasts about 4 years. Patients return~     to the clinic at 2, 4, 8 and 12 weeks after the entry visit, then every 12 weeks (about every~     3 months) until week 48 (the first year), and then every 16 weeks (about every 4 months)~     until the end of the study. At most visits, patients have a medical history, physical~     examination and blood and urine tests, including CD4+T cell count and HIV plasma viral load~     measurement. Apheresis is also done at weeks 24 and 48 and then once every 48 weeks.~     Intestinal and lymph node biopsies (optional) are also done at weeks 24 and 48. A syphilis~     test and PAP smear (for women) are done yearly. and plasma, cells and serum are stored at~     almost every visit for immunologic studies.~   "
249499|NCT00286741|"~     Background: Diabetes is a common, morbid and expensive disease among veterans. Achieving~     adequate glycemic control and blood pressure control can reduce the devastating complications~     of diabetes. Because the majority of patients do not achieve adequate control of blood sugar~     and blood pressure, innovative strategies to improve control are needed. One strategy with~     great potential for veterans receiving VA care is the group clinic. Group clinics have been~     developed over the last 5-10 years, and have been shown to improve clinical outcomes and~     reduce outpatient utilization in geriatric settings. Group medical clinics involve a cohort~     of 8-20 patients who have 1-2 hour group visits. These clinics are distinguished from~     traditional group education visits for diabetes by the fact that these visits involve one~     physician and one or more additional health care professionals, usually a nurse practitioner~     and/or a pharmacist, and are designed to make management changes for a number of people with~     the same disease in a short period of time. The effect of group medical clinics on blood~     sugar, blood pressure, and the cost of diabetes care, is unknown. Objectives: Our primary~     objectives in this project are to determine the effectiveness and cost-effectiveness of a~     group visit intervention in improving rates of control of diabetes and high blood pressure in~     patients with both illnesses.~   "
249500|NCT00286728|"~     This project will help counselors in substance abuse treatment programs make effective~     referrals of dually diagnosed patients (those with a co-occurring psychiatric disorder) to~     self-help groups.~   "
249501|NCT00286702|"~     After a stroke, many people develop contracture of the muscles in their affected wrist and~     hand which leads to a permanently clenched, painful hand. A contracture is often treated by~     therapists who use hand splinting to prevent it occurring or slow down its progression.~     Despite their wide use, there has not been research completed to investigate whether or not~     splinting prevents contracture in people following stroke. In fact, this project will be the~     first of its kind in the world and is therefore vital to stroke rehabilitation.~      The study is a multi-centre, randomised controlled trial that will measure the effect of~     hand-splinting in two positions on the prevention of contracture, functional use of the hand,~     and quality of life.~   "
249502|NCT00286689|"~     The specific aims for this study are –~        1. To determine the effect of GH on height, height velocity, body weight and lean body~          mass. This specific aim tests the hypothesis that GH significantly improves height,~          height velocity, weight, weight velocity and lean body mass in chronically ill children~          who have grown poorly despite adequate nutritional rehabilitation.~        2. To determine the effect of GH on whole body protein turnover (WBPT), IGF-1 levels and on~          cytokines. This specific aim tests the hypothesis that chronically ill children have~          increased catabolism, caused by high levels of circulating cytokines and low levels of~          IGF-1, and that these abnormalities improve with GH treatment.~        3. Evaluation of bone mineral density and bone turnover. This specific aim tests the~          hypothesis that bone density is low in chronically ill children secondary to increased~          osteoclast activity correlating with elevated cytokine levels.~      We hypothesize that the anabolic effects of growth hormone (GH) will improve the height and~     weight of chronically ill children who have failed to grow despite receiving adequate~     nutrition via gastrostomy tube or oral supplementation.~   "
249503|NCT00286676|"~     This is a pilot study. We will treat 10 HIV-infected adults (1/2 with lipoatrophy) with GH~     depot for one year. Results will be compared to data from 10 HIV patients (1/2 with~     lipoatrophy), treated with Nutropin AQ subcutaneously. The primary endpoint of the study is~     to determine the effect of GH depot on body weight and lean tissue mass (LTM).~      The secondary endpoints are to document changes in: 1) whole body protein turnover (WBPT), 2)~     gluconeogenesis, 3) bone mineral density and markers of bone turnover, 4) fat distribution~     (lipoatrophy), 5) thymus size, 6) T-cell subsets, and 7) TNF-µ levels. Adverse events, such~     as glucose intolerance and edema, will be monitored at every visit.~   "
249504|NCT00286663|"~     The purpose of the study is to determine the role special antibodies play in possibly~     identifying Autoimmune Hepatitis through the following:~      Identify the response of specific T cells to antibodies and Monitor the response of the cells~     that regulate the immune system~   "
249505|NCT00286650|"~     Paracetamol is commonly used to reduce pain after operations. Recently anaesthetists have~     been using bigger doses of paracetamol because it has been suggested that bigger doses will~     work better. However these bigger doses have never been assessed scientifically in adult~     patients to see if they work better, and it has not been determined at which dose the maximum~     effect in reducing pain occurs. We We will investigate whether a 90 mg per kg body weight~     dose works better than a 60 mg per kilogram dose, in reducing pain after wisdom tooth~     extraction. We will also examine the pharmacokinetics (the way the body removes the drug) of~     paracetamol, and whether paracetamol changes the way blood clots at these doses. We will also~     examine whether these doses are safe, by monitoring liver enzymes, and making sure the blood~     level of paracetamol is not greater than that previously recognised to cause liver disease.~     The patients will be healthy volunteers scheduled to have wisdom tooth extraction. They will~     have blood taken at intervals for four hours after having the paracetamol. They will fill in~     pain scores at the same times they have blood taken.~   "
249506|NCT00286637|"~     The purpose of this research is to evaluate novel technologies for the assessment of ocular~     structure and function, including the scanning device called Optical Coherence Tomography~     (OCT). We will test the OCT and other devices in their ability to image diseases of the eye~     and also compare the measurements made with OCT to those of other imaging and visual field~     devices approved by the Food and Drug Administration (FDA). OCT may be useful for the early~     diagnosis and monitoring of a variety of types of eye diseases~   "
249507|NCT00286624|"~     This study was designed to test the safety and efficacy of up to 3 pancreatic alloislet~     transplants in type 1 diabetic patients with hypoglycemia unawareness. 6 subjects were~     transplanted under this protocol using anti-thymocyte globulin induction immunosuppression~     and everolimus with cyclosporine maintenance immunosuppression.~   "
249517|NCT00286494|"~     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily~     (QD), combined with pioglitazone in adults with type 2 diabetes mellitus~   "
249518|NCT00286481|"~     The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or~     with simvastatin on cholesterol levels in treating patients with elevated cholesterol.~   "
249508|NCT00286611|"~     Currently, there are no published methods for easily determining the level of amifostine in~     the blood or saliva. A method has been developed within the Department of Radiation Oncology~     by Drs. Douglas Spitz and Gurminder Sidhu, within the Spitz Lab. This method has been tested~     using both animal sampling and expired blood (obtained from DeGowin blood center) mixed with~     amifostine.~      If the method proves successful, it could then be used as a tool to quantify blood and~     salivary amifostine levels and possibly correlate them to treatment efficacy or limiting~     adverse events using amifostine. A better method of treatment, either increasing the efficacy~     of amifostine or reducing its unwanted side effects, could then be developed.~   "
249509|NCT00286598|"~     The role of weight-bearing physical activity in the development of diabetic foot ulcers~     remains poorly understood. Regular participation in moderately intense physical activity~     (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus~     by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily~     moderate intensity activity for people with diabetes. However, the ADA recommends that people~     with diabetes and insensate feet, which affects up to 40% of those with diabetes, should~     limit their walking because of concerns that walking could increase the risk of foot ulcers~     and amputation. Firm evidence is lacking to support these concerns; in fact, while a research~     fellow I conducted an observational study that showed daily weight-bearing activity may~     reduce the risk of foot ulceration among people with diabetic foot problems. A controlled~     clinical trial is needed to study these issues further.~      The present study is a randomized controlled trial in 100 older adults with diabetes and~     insensate feet, 50 of whom will participate in an individually-tailored behavior-change~     intervention called Feet First, and 50 of whom will be controls. The intervention is based~     on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active~     for Life Program. Feet First extends the target population beyond older adults generally to~     people with insensate feet due to diabetic peripheral neuropathy.~      The specific aims of the study are:~        -  To determine whether Feet First intervention subjects achieve a greater increase in~          weight-bearing activity than control subjects, and~        -  To obtain preliminary evidence on intervention subjects' foot outcomes (foot function,~          foot-related self-care, and risk of foot ulcers), compared to control subjects.~   "
249510|NCT00286585|"~     Volatile anesthetics may provide some protection from myocardial ischemia, an effect called~     anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this~     preconditioning effect resulted in better cardiac performance, faster recovery and lower~     morbidity and mortality.~      The investigators will perform a prospective randomized multi-center study to compare~     volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo~     major non-cardiac surgery.~   "
249511|NCT00286572|"~     Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no~     diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better~     survival than patients with oral antidiabetics. But there is not known wether perioperative~     therapy with insulin or oral antidiabetics is associated with higher risk for higher~     perioperative cardiac morbidity and mortality and worse long-term survival.~   "
249512|NCT00286559|"~     Until today it was not possible to reliably assess the function of a new bypass, i.e., to~     measure myocardial perfusion. Measuring intramyocardial blood flow directly after~     revascularisation would greatly improve the assessment of graft function. With transthoracic~     contrast echocardiography, myocardial perfusion can be reliably assessed, as it has been~     shown in numerous studies. In the first part of the study the investigators will clarify~     methodological aspects of contrast echocardiography. In the second part they will analyze the~     validity of contrast TEE in the operating room.~   "
249513|NCT00286546|"~     Context - As men age, testosterone levels decline leading to symptoms that overlap with the~     symptoms of major depression. Little is known about the potential role of testosterone in the~     treatment of major depression.Objective - To assess the levels of bioavailable testosterone~     and total levels of testosterone in men diagnosed with major depressive disorder between the~     ages of 40 and 65.Design, Setting and Participants - 50 men between the ages of 40 and 65 and~     who suffer from major depressive disorder will be compared with 50 age matched healthy~     controls in an outpatient hospital setting. Main Outcome Measures - Bioavailable testosterone~     and total testosterone levels will be measured as well as blood pressure, pulse rate, height,~     weight, waist and hip measurements. Medical and psychiatric history will be assessed by the~     study physician. The Mini International Neuropsychiatric Interview (MINI) will be used to~     administered by the physician to ensure that the patient meets the DSM-IV criteria for Major~     Depression. The Hamilton Depression Rating Scale (HAM-D-17) will be used to assess depression~     symptom severity. A Symptom/Side Effect Rating Scale will also be administered to measure the~     presence and severity of side effects that each patient may be experiencing. In addition, the~     SEX FX questionnaire will be administered. Each patient will be asked to complete a series of~     self-report measures including the Social Adaptation Self-Evaluation Scale Questionnaire~     (SASS), the Androgen Deficiency in Aging Males (ADAM) and the Beck Depression Inventory~     (BDI-II).~   "
249514|NCT00286533|"~     This study is an evaluation of the implants placed in a regular dentist's practice regarding:~        -  gingiva condition~        -  stability of implant~        -  prothetic quality~        -  questionnaires for the patients~   "
249515|NCT00286520|"~     The study aims to compare a newly developed system for transanal colonic irrigation~     (Peristeen Anal Irrigation) with a bowel management regime that does not include irrigation~     in a prospective, randomized trial in spinal cord lesion patients (SCL- patients) with faecal~     incontinence and/or constipation.~      Population; 80 SCL- patients with faecal incontinence and/or constipation from five~     countries.~      Focus on:~      Bowel symptom score Neurogenic Bowel Dysfunction score Symptom related quality of life~     questionnaire Time expenditure for performance of bowel care ans side effects~   "
249516|NCT00286507|"~     A macular hole is a fairly common problem in the retina and is an important cause of loss of~     central vision. The aim of this study is to determine whether, in patients with a stage 2 or~     3 full thickness macular hole (FTMH), peeling a very fine, transparent tissue that covers the~     surface of the retina, called the internal limiting membrane (ILM) during surgery is superior~     to non-ILM peeling macular hole surgery. The main outcomes are improvement in vision,~     achievement of macular hole closure, need for re-operation, health related quality of life~     (HRQOL) and cost effectiveness.~   "
249523|NCT00286416|"~     Double blind protocol treatment of 2/3 of the patients with omalizumab and 1/3 placebo~     administer for 4 months. Patients selected for the study must have both aspirin exacerbated~     respiratory disease and allergic asthma and rhinitis. They must also have completed aspirin~     desensitization and be taking aspirin on a daily basis for the treatment of AERD.~   "
249524|NCT00286403|"~     Patients developing kidney failure after open heart surgery experience an abrupt decrease in~     blood flow to the kidney. The investigators hypothesize that administration of fenoldopam~     mesylate (a drug that increases blood flow to the kidney) to patients early in the course of~     their disease could reduce progression to dialysis-dependent acute renal failure. The~     investigators also hypothesize that restoring blood flow could induce additional injury to~     the kidney through the release of reactive oxygen species. Therefore, patients in this~     protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. The~     investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease~     the incidence of death or dialysis at 21 days in patients with early post-operative acute~     renal failure.~   "
249525|NCT00286390|"~     The purpose of this project is to conduct a scientifically rigorous investigation of the~     clinical outcomes, quality of life, and cost associated with the delivery of acupuncture in~     the treatment of acute and chronic pain in patients at Malcolm Grow Medical Center, Andrews~     Air Force Base.~      The specific aims of this study are to:~        1. Gather outcomes and patient satisfaction data on patients receiving acupuncture~          treatment for acute and chronic pain.~        2. Perform an analysis of costs, including any system cost savings, associated with~          providing acupuncture services to pain patients.~        3. Serve as a model to expand the project to Scott AFB and Travis AFB as per the request of~          the Air Mobility Command Surgeon General. (AMC/SG).~   "
249526|NCT00286377|"~     This is a double-blind, placebo-controlled, parallel groups study to determine whether~     prosptide is effective in relieving pain in patients who have sensory neuropathic pain~     related to their HIV infection or the drugs used to treat it.~   "
249527|NCT00286364|"~     We want to investigate if early follicular phase downregulation and androgen priming, by use~     of GnRH antagonist, aromatase inhibitor and hCG before COH in a short protocol, shows signs~     of improvement compared to standard short antagonist protocol~   "
249528|NCT00286351|"~     Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following~     IVF outcome~   "
249529|NCT00286338|"~     The investigators want to correlate different methods to guide fluid therapy. The~     investigators know that guidance by esophagus doppler technique has improved outcome and want~     to correlate other already used techniques to esophagus doppler.~   "
249530|NCT00286325|"~     This study will determine the safety of treatment of bullous pemphigoid in patients resistant~     to therapy with systemic corticosteroids, with rituximab plus systemic corticosteroids.~   "
249531|NCT00286312|"~     The purpose of this study is to determine if oral atorvastatin administered just before~     percutaneous coronary angioplasty for acute myocardial infarction improves early and late~     heart function as compared to placebo.~   "
249532|NCT00286299|"~     This study investigates treatment effects from aerobic endurance training, maximal strength~     training and computer game on aerobic capacity, work efficiency and psychiatric symptoms in~     patients suffering from schizophrenia. The study is a controlled trial. The aim is to~     describe the population in respect to aerobic capacity and muscular strength. Low aerobic~     capacity and muscular strength are important risk factors for cardiovascular disease (CVD).~     The study also aim to evaluate physical and psychiatric effects from physical training.~     Effects from participation in physical training or computer game on symptoms, depression and~     quality of life will be investigated. Data will be collected between October 2005 and August~     2007.~   "
249533|NCT00286286|"~     The purpose of this study is to determine the effectiveness of aerosolized pain medication~     (.5% bupivicaine) delivered into the peritoneal cavity after laparoscopic gastric bypass~     surgery. This double blind study will include 50 patients. 25 will receive the aerosolized~     pain medication and 25 will receive a placebo (normal saline). All 50 patients will receive~     routine/typical methods of post-operative pain management. Post operative pain scores of the~     patients will be examined to determine the effect of aerosolization.~   "
249534|NCT00286273|"~     Severely ill patients admitted to the intensive care unit may develop an acute failure of~     kidney function. To bridge the period to recovery, renal function is temporarily replaced by~     continuous venovenous hemofiltration (CVVH). To prevent clotting of the hemofiltration~     circuit, heparin is generally used, providing anticoagulation in the circuit and the patient.~     As a result, bleeding complications may occur, necessitating the transfusion of blood.~     Anticoagulation of the circuit can also be obtained with the use of tri-sodium citrate, which~     provides anticoagulation of the circuit without affecting coagulation in the patient and thus~     without increasing his/her risk of bleeding. The use of citrate may however cause metabolic~     complications.~      Primary aim of the present study is to show in a larger group of intensive care patients~     whether the use of regional anticoagulation with citrate is safe compared to systemic~     anticoagulation with the low molecular weight heparin nadroparin.~   "
249535|NCT00286260|"~     Polyneuropathy of different etiologies is often associated with pain. The standard treatment~     of this pain is anticonvulsants or antidepressants, but none of these treatment are effective~     or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the~     hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised,~     double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000~     mg/day on pain in polyneuropathy~   "
249536|NCT00286247|"~     A maximum of 60 subjects will be enrolled in the trial. It is a non-randomized, open label,~     single center study. All subjects undergo INGN 201 injection and IV chemotherapy: doxorubicin~     and docetaxel. This is done on the first 2 days of a 3-week cycle. After completion of 4 to 6~     cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off~     study if there is no tumor response.~   "
249565|NCT00285870|"~     Dr. Sanger and the research team want to learn about upper extremity hypertonia (stiffness)~     in children and young adults with cerebral palsy. Specifically, they want to learn about ways~     to measure the stiffness in the joints of hypertonic arms. The information the research team~     will collect includes any physical exams or computer generated data about your arm movements.~   "
249537|NCT00286234|"~     This research study is being conducted to test the effects of two drugs on blood lipids~     (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or~     pre-diabetes (both of which have a condition called insulin-resistance). These products~     are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We~     hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels,~     increase HDL-cholesterol levels and do so without altering glucose levels.~   "
249538|NCT00286221|"~     This is a prospective, randomized controlled clinical trial to evaluate the efficacy and~     safety of intravenous patient controlled analgesia (IVPCA) in patients following major~     intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid~     consumption, costs, sedation level, length of hospital stay, patient satisfaction, and~     complications in patients randomized to receive either pro re nata (PRN) or IVPCA opioids. We~     hypothesize that IVPCA will be more efficacious than PRN opioids in the treatment of~     postoperative without an increased incidence of adverse effects.~   "
249539|NCT00286208|"~     This open-label, randomized study is being conducted to determine whether a dose of 400 mcg~     of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of~     mifepristone 200 mg is effective and acceptable at inducing an abortion compared with~     misoprostol taken orally.~      The goal of this study is to provide answers to the following four questions:~        1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least~          as effective as using oral misoprostol up to 63 days since the last menstrual period~          (LMP)?~        2. Are the side effects with sublingual use tolerable for women?~        3. Is sublingual administration of misoprostol acceptable to women?~        4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety~          (side-effects) or acceptability?~   "
249540|NCT00286195|"~     To assess the procedural success, performance, 30-day and 6 month clinical outcome of~     bifurcation stenting, and the six month incidence of clinically indicated target lesion~     revascularization with the use of the Abbott Vascular MULTI-LINK FRONTIER Coronary~     Bifurcation Stent System in patients with de novo or restenotic bifurcation lesions.~   "
249541|NCT00286182|"~     The purpose of this study is to determine if treating anemia with subcutaneous erythropoetin~     in patients with heart failure and a preserved ejection fraction (HFPEF) will be associated~     with reverse ventricular remodeling, significant improvements in exercise capacity, and~     improved health status, as compared with placebo.~   "
249542|NCT00286169|"~     The purpose of this study is to compare the efficacy and toxicity of amrubicin with~     carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.~   "
249543|NCT00286156|"~     This study is a prospective, randomized, open-label, pilot clinical trial designed to compare~     the effects of an agent that has antiproliferative (1,2), antiangiogenesis (3),and~     tumor-progression blocking capabilities (4), namely, rapamycin (Rapamune®), in the treatment~     of autosomal-dominant polycystic kidney disease (ADPKD).~      Up to this time, only generic renal disease treatments for ADPKD have been in use, such as~     the treatment of hypertension, urinary tract infections, renal stones, renal call carcinomas,~     and replacement therapy with dialysis and/or renal transplantation. The fundamental~     aberrations in ADPKD are proliferation of cyst-forming tubuloepithelial cells, secretion of~     cytokine-rich fluid into those cysts, and progressive cyst expansion and release of~     inflammatory mediators that injure surrounding normal renal tissue. Consequently, therapy~     directed specifically at blocking the proliferation of tubuloepithelial cells and their~     tendency to malignant transformation, as well as impeding their blood supply, should have~     obvious merit.~      General Procedures:~      In Group I participants will have an iothalamate glomerular filtration rate (GFR) equal to or~     greater than 60 ml/min/1.73 m2, and in Group II participants will have a GFR less than 25-59~     ml/min/1.73 m2. Both males and females with ADPKD who volunteer and qualify, will be randomly~     and prospectively assigned to treatment with rapamycin at either a high or low trough blood~     level or to standard care (each 1/3 of enrolled patients) for one year. The two treatment~     groups will receive rapamycin doses aimed at maintaining the 20- to 24-hour trough blood~     levels at either 2 to 5 ng/mL (low-dose), or greater than 5 to 8 ng/mL (high-dose). These~     trough levels are in the lower range of levels used when treating renal transplant recipients~     in whom trough levels are typically maintained between 5 and 15 ng/mL.~   "
249544|NCT00286143|"~     The study exams whether adding an opioid to the epidural infusion of a local anesthetic in~     neonates will significantly improve the quality of the postoperative analgesia.~   "
249545|NCT00286130|"~     In Patients with metastatic colorectal cancer the following treatments first-line~     Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.~      The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety~     as first~   "
249546|NCT00286117|"~     The purpose of this study was to assess the difference in disease-free survival between~     post-menopausal women with hormone receptor-positive early breast cancer who switched from~     tamoxifen to anastrozole and those who continued on tamoxifen.~   "
249547|NCT00286104|"~     External ventricular catheters are used for intracranial pressure monitoring and temporary~     cerebrospinal fluid (CSF) drainage in neurosurgery. The incidence of ventriculostomy-related~     cerebrospinal fluid infections had been quoted as between 2.2% to 10.4% in the more recent~     literature. Previous prospective studies in the investigators' unit have shown that the use~     of dual antibiotics prophylaxis in patients with external ventricular drain was associated~     with decreased incidence of CSF infection but was complicated with opportunistic extracranial~     infections. The current practice is to cover with prophylactic dual antibiotics unless guided~     by microbiology results for all patients with external ventricular drain. In recent years,~     cerebrospinal fluid shunt catheters impregnated with antimicrobial agents have been~     available. Experimental studies have shown that they provide protection against~     staphylococcal aureus and coagulase-negative staphylococci strains for between 42 days and 56~     days. Theoretically, they provide the antibiotic prophylaxis locally without the associated~     complications of systemic antibiotics.~      It is hypothesized that the use of antibiotic-impregnated catheters instead of systemic~     antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will~     decrease the rate of opportunistic/nosocomial infections and improves the overall outcome in~     these patients; that would convert into a reduction in treatment cost of these patients.~   "
249548|NCT00286091|"~     The purpose of this study is to compare the treatment effect of denosumab with placebo on~     prolonging bone metastasis-free survival in men with hormone refractory (androgen~     independent) prostate cancer who have no bone metastasis at baseline.~   "
249549|NCT00286078|"~     The purpose of this study is to evaluate the safety and effectiveness of an implantable~     device for difficult to treat migraine. There are a significant number of patients who have~     drug refractory migraine and alternative therapies are needed.~   "
249551|NCT00286052|"~     Recently there has been an increased awareness in the need for adequate sedation and pain~     control for Pediatric Intensive Care Unit (ICU) patients. Fentanyl is an opioid commonly used~     in Pediatric ICU patients to decrease pain and increase sedation. Although opioids (e.g.~     morphine and fentanyl) provide excellent pain relief, they have many side effects including~     dependence, tolerance and withdrawal. These side effects lead to increased doses in order to~     maintain pain control and/or sedation. There have been a few adult studies pointing to some~     possible treatments. For example, giving low dose naloxone along with opioids. Adult studies~     show that this combination not only decreases the frequency of opioid side effects, but also~     improves pain control and prevents the development of tolerance. We propose that children who~     receive low dose naloxone infusions along with fentanyl infusions will demonstrate: 1)~     decreased total daily doses of Fentanyl, 2) decreased frequency of withdrawal and 3)~     increased pain and sedation control. In this randomized, blinded prospective trial we will~     enroll 168 Pediatric ICU patients. Patients will receive either low dose naloxone or placebo~     simultaneously with their fentanyl infusion. Pain and sedation will be assessed using the~     Modified Motor Activity Assessment Scale (MMAAS). The fentanyl infusion will be increased to~     provide adequate pain control and/or sedation. Naloxone infusion will not be adjusted.~     Approximately 48 hours prior to removal from the ventilator, patients will have their~     fentanyl infusions decreased while being monitored for withdrawal. Patients showing signs of~     withdrawal will receive methadone, an opioid taken by mouth. Once off fentanyl, naloxone will~     be stopped. Patients will continue to be monitored for withdrawal for 4 days or until ICU~     discharge. If this study works, patients who receive low dose naloxone along with opioid~     infusions will have less tolerance and dependence and demonstrate less withdrawal. This may~     cause shorter Intensive Care Unit stays.~   "
249552|NCT00286039|"~     Correlation between determination of citrulline in plasma or dried blood~      Reference ranges for healthy children and babies~      Longitudinal follow-up of citrulline in preterm babies~   "
249553|NCT00286026|"~     Trachoma is the world's leading cause of preventable blindness. This disease, caused by~     Chlamydia trachomatis, is endemic in many parts of the developing world. In 1990s we~     evaluated the use of community-wide treatment with oral azithromycin in a project called~     Azithromycin in Control of Trachoma (ACT). This approach resulted in clinical improvement and~     dramatic reduction in prevalence of chlamydial infection through a 1-year follow-up. We~     enrolled the ACT villages, as well as an additional village that had not had any prior~     treatments, in our ACT II (2005) study and performed clinical surveys to assess trachoma~     activity testing conjunctival swabs for the presence of C. trachomatis by nucleic acid~     amplification tests (NAATs). Thus, we hoped to determine the long-term (10 year) effects of~     azithromycin treatment.~      We have completed the census and clinical survey of the initial three villages. Mass~     treatment with azithromycin would not be justified with such low rates (1.8 - 4%) of ocular~     chlamydial infection. We have treated only those living in households with one or more cases~     of chlamydial infection and we will not follow up on these individually treated families.~      In order to achieve the goals of our study, we now propose to identify other more remote~     villages with trachoma infection rates of 20% or more to evaluate the effect of~     community-wide treatment with single dose of oral azithromycin. If one or more of these~     villages (dependent upon population) has trachoma rates of 20% or more they will be invited~     to participate in the azithromycin treatment. In one set of subjects (1 or 2 villages,~     dependent upon population and infection rate) we will perform treatment, and follow them up~     at 2-, 12-, and 24-months post-treatment to ascertain infection rates. In a second set of~     subjects (1 or 2 villages, dependent upon population and infection rate) we will perform~     treatment, then perform re-treatment at 30-days post initial treatment, and follow them up at~     2-, 12-, and 24-months post-treatment to ascertain infection rates. This should help us~     determine the need for/and the best time for re-treatment to eliminate blinding trachoma, as~     some recent studies suggest there is a 2-4% failure rate in the initial treatment. In sum,~     this study should provide a rational approach to use of community-wide azithromycin treatment~     to eliminate blinding trachoma as a public health problem~   "
249554|NCT00286013|"~     The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity~     as well as relative dose-intensity and cumulative dose delivered, of an association~     ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and~     unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma~   "
249555|NCT00286000|"~     A multicentre phase II study to evaluate the results of high dose simplified folfiri in~     advanced colorectal cancer~   "
249556|NCT00285987|"~     Study to compare the quality of life after reconstruction of the cruciate ligament in~     hospitalized versus day-clinic patient~   "
249557|NCT00285974|"~     Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five~     different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic~     prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling~     preoperatively, and 3, 6, 12 and 24 months postoperatively.~   "
249558|NCT00285961|"~     This is an evaluation of the functionality and added value of cork splint materials instead~     of a plaster splint for children (3-11 years old).~   "
249559|NCT00285948|"~     To prospectively obtain data about the clinical and radiological results of the resurfacing~     technique as primary hip prosthesis in young active patients~   "
249560|NCT00285935|"~     We are conducting an eight week longitudinal study to learn if blood levels of certain~     naturally occurring compounds and genetic markers differ between patients with depression and~     healthy adults who are not depressed, and if any such differences relate to memory~     performance, mood, and neurobiology.~      We will do this by comparing the unmedicated depressed patients with matched healthy controls~     at baseline and then following the depressed patients over the course of eight weeks of~     standardized antidepressant treatment to gauge which baseline abnormalities normalize over~     the course of treatment.~   "
249561|NCT00285922|"~     The aim of this study is to improve the detection of heart attack in people who come to a~     hospital emergency room (ER) with cardiac symptoms. We are testing a novel technology that~     calculates the heart's electrical activity at points all around the upper body torso and~     develops a map showing areas indicating heart attack. Our hypothesis is that this new body~     mapping technique will be better than the standard electrocardiogram (ECG) in detecting heart~     attack.~   "
249562|NCT00285909|"~     Moderate alcohol consumption is associated with a decreased risk of cardiovascular disease~     and type 2 diabetes. The association of alcohol consumption with cardiovascular disease is~     mediated by a functional polymorphism of alcohol dehydrogenase 1c, but the effect of this~     polymorphism on alcohol metabolism is only investigated in vitro.~      The risk reduction of moderate alcohol consumption for cardiovascular disease is explained~     largely by an increase of HDL cholesterol, but an increase of adiponectin concentrations~     after moderate alcohol consumption may also be involved. It seems likely that adiponectin is~     a mediator for the association of moderate alcohol consumption with type 2 diabetes. The~     mechanism by which moderate alcohol consumption increases adiponectin concentrations is~     unknown, but ppar-gamma activation may be involved.~      effects of this polymorphism on mediators of this relation are not known. This study~     therefore investigates the effect of moderate alcohol consumption and the influence of~     alcohol dehydrogenase 1c polymorphism on ppar-gamma activated gene expression and risk~     factors of cardiovascular disease and type 2 diabetes.~   "
249563|NCT00285896|"~     GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion~     in a glucose dependent way. Below normal plasma glucose levels the effects of GLP-1 stop and~     the risk of hypoglycemia is small. However no results exits on the effects pharmacologically~     relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in~     healthy people after a fasting period when a glucose load is administered. The risk of~     hypoglycemia when GLP-1 is administered will be evaluated during these two conditions.~   "
249567|NCT00285844|"~     The goal of this study is to determine why some obese individuals develop insulin resistance~     and others do not. We hypothesize that an impairment in differentiation of fat cells~     (adipocytes) is responsible for the development of insulin resistance in select obese~     individuals. This study will evaluate obese individuals at baseline with respect to~     characteristics of adipocytes, including gene expression, and will then entail randomizing~     subjects to either weight loss or treatment with an insulin sensitizing drug (pioglitazone).~     Changes in insulin resistance will be associated with changes in adipocyte morphology and~     gene expression.~   "
249568|NCT00285831|"~     The purpose of this study is to assess whether the dysphoric-like depressive characteristics~     observed in people with epilepsy are unique to this patient population in comparison to three~     control groups: Mild Depression (enrolled at Stanford University), Migraine Headaches~     (enrolled at Long Island Jewish Medical Center), and Multiple Sclerosis (enrolled at Rush~     University Medical Center).~   "
249569|NCT00285818|"~     The purpose of this study is to see whether the medication mifepristone is an effective and~     tolerable treatment for increasing the clinical effectiveness of electroconvulsive therapy~     (ECT) and protecting cognitive function during ECT. Both Mifepristone and ECT appear to~     normalize hyperfunctioning of the hypothalmic-pituitary-adrenal (HPA) axis, which has been~     found among patients with major depression referred for ECT. The combination of these two~     treatments in major depression may lead to a more rapid clinical response than ECT alone.~     Additionally, there appears to be a connection between pre-ECT higher cortisol levels due to~     HPA axis hyperfunctioning and post-ECT cognitive impairment. Administration of mifepristone~     prior to and during ECT treatment may reduce cortisol levels and reduce the incidence of~     cognitive impairment observed after ECT.~   "
249570|NCT00285805|"~     Thiazolidinedione derivates (TZD's) are Peroxisome-Proliferator-Activated-Receptor-γ agonists~     (PPARγ-agonists) and enhance insulin sensitivity. One of the side effects, however, is the~     fact that subjects treated with these drugs seem to be more prone to fluid retention. The~     precise mechanism of rosiglitazone-related fluid retention is unknown, but it is clear that~     either primary or secondary renal sodium retention is part of the mechanism. Furthermore in~     observational studies, TZD-related oedema seems to be resistant to loop diuretic therapy. The~     recent finding that rosiglitazone induces upregulation of the epithelial sodium channel~     (ENaC) in the kidney could be the explanation for TZD-related fluid retention and the~     observed resistance to loop diuretics. In the present human in-vivo study the following~     hypothesis will be tested:~      Rosiglitazone treatment stimulates the activity of ENaC in the distal nephron, which enhances~     the natriuretic effect of amiloride and decreases the natriuretic effect of furosemide in~     parallel.~   "
249571|NCT00285792|"~     The purpose of this study is to examine the effects of increasing the amount of time spent in~     recess (outside playtime) on overall daily physical activity in Hispanic preschool age~     children attending full-day and half-day preschool programs. We hypothesize that increasing~     recess (outside playtime) by 60 minutes in participants attending full-day and 30 minutes in~     participants attending half-day of preschool will increase average daily physical activity~     during the intervention days. We also hypothesize that children will not compensate for the~     increased recess (outside playtime) by decreasing physical activity outside of school during~     the intervention days.~   "
249572|NCT00285779|"~     The purpose is to assess the response of subjects to etanercept (as compared to placebo) in~     treating the physical signs of mucosal and cutaneous lichen planus. The investigators also~     wish to assess the effect of etanercept on disease-related itching, pain, and serious adverse~     events in patients with lichen planus.~   "
249573|NCT00285766|"~     Objective of this 16-week, open-label study is to assess the safety and tolerability of once~     daily application of three doses of STS during continuous dosing in the treatment of elderly~     subjects with major depression. Subjects will have study visits (clinic visits) at beginning~     of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.~   "
249574|NCT00285753|"~     This study aims at developing and evaluating a support group program for patients with mild~     cognitive impairment (MCI) and their partners. These patients have defective memory function~     but are not demented. However, there is an increased chance of developing dementia in the~     near future; 10-15% per year for MCI patients, in contrast to 1-2% per year for healthy~     elderly persons. For the patients and their caregivers this means that they are confronted~     with feelings of uncertainty and fear towards the future. They also have many questions about~     how to improve their memory problems and how to cope with other changes or consequences.~      The purpose of the support group program is to improve coping skills and facilitate~     adaptation to the impairments, in order to reduce anxiety or depression and strengthen~     feelings of competence in patients and their partners.~   "
249575|NCT00285740|"~     This study involves a form of group therapy called Cognitive Behavioral Therapy or CBT for~     depressed patients with Epilepsy. The CBT groups will be tailored for an epilepsy clinic~     population. There are 12 sessions of therapy in the study held once a week for 12 weeks.~   "
249576|NCT00285727|"~     This is an 8 week study for patients who are currently taking antidepressant medication but~     not fully responding. Ropinirole CR would be taken in conjunction with current antidepressant~     medication. Patients come into the clinic once a week when starting on the medication and~     then once every other week for the remainder of the 8 weeks.~   "
249577|NCT00285714|"~     The primary objective of this clinical trial is to assess the influence of orthognathic~     surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and~     soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.~   "
249578|NCT00285701|"~     Patients referred for colon inspection (colonoscopy) due to suspicion of colon polyps/cancer~     will receive local administration of hexaminolevulinate (HAL) prior to colon inspection. Blue~     light illumination will induce red fluorescence of polyps and tumours, improving detection of~     the polyps and tumors. Different HAL doses will be tested to find the optimal image~     conditions. Tolerability measurements will be performed to ensure patient safety.~   "
249590|NCT00285545|"~     The lack of blood flow to the small intestine causes mesenteric ischemia. Using a~     Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the~     small intestine, we are hoping to identify abnormalities without surgical intervention.~   "
249794|NCT00282815|"~     The purpose of this study is to determine if treating stroke patients who have obstructive~     sleep apnea with continuous positive airway pressure will improve symptoms caused by the~     stroke.~   "
249579|NCT00285688|"~     Peptic ulcer disease is the most common gastrointestinal disease. Antibiotic resistant~     Helicobacter pylori is a major problem worldwide. The gold standard for Helicobacter pylori~     eradication is composed of Proton-pump inhibitor/Ranitidine bismuth citrate + Amoxycillin +~     Metronidazole /Clarithromycin. In Thailand, clarithromycin resistant strains increased and~     led to treatment failure. Data on file at Rajavithi Hospital showed that metronidazole~     resistant H. pylori was about 50% and Clarithromycin resistant strains accounted for 8%. This~     molecular genetic study will be performed in patients presenting with dyspepsia, who had an~     indication for gastroscopic examination, to explore the incidence of antibiotic resistant~     Helicobacter pylori in Rajavithi Hospital, Thailand.~   "
249580|NCT00285675|"~     The purpose of this study is to monitor the safety of continued DN-101 and docetaxel~     treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC)~     Studies.~   "
249581|NCT00285662|"~     In malaria-endemic areas, young children have an especially high risk of malaria morbidity~     and mortality. Malaria is estimated to cause up to 2 million deaths and 500 million clinical~     episodes in Africa alone. The bulk of disease in Africa and severe disease and deaths~     globally is due to P. falciparum. However, P. vivax is also responsible for a substantial~     disease burden in endemic regions outside Africa, where P. vivax may account for more than~     half of all malaria cases. Efforts to reduce this unacceptably high disease burden are~     hampered by the limited availability of affordable interventions. Following the cessation of~     large-scale vector control in highly endemic areas, malaria control efforts have centred on~     early diagnosis and treatment of clinical cases and reducing exposure through the use of~     insecticide-treated nets (ITNs). While ITNs have been shown to significantly reduce the~     burden of malaria additional effective interventions are urgently needed.~      Several trials have shown that chemoprophylaxis given to children at weekly or fortnightly~     intervals reduces morbidity from malaria in a number of different settings and populations.~      An alternative approach has been to use intermittent preventive therapy (IPT) involving the~     administration of a full therapeutic dose of antimalarials at regular intervals. This is~     logistically easier to deliver, and is less costly, and may reduce problems of promoting drug~     resistance associated with regular chemoprophylaxis. Intermittent administration of~     sulphadoxine-pyrimethamine (SP) during antenatal clinic visits was shown to be highly~     effective in reducing malaria and anaemia in pregnant women and improving infant birth~     weights. IPT in pregnancy (IPTp) is now recommended by WHO for endemic regions of Africa.~   "
249582|NCT00285649|"~     The purpose of this study is to compare the clinical effectiveness of two types of~     chiropractic spinal manipulation to conservative medical care for patients at least 55 years~     old with sub-acute or chronic LBP.~   "
249583|NCT00285636|"~     The purpose of the study is to investigate the psychological effects of burn injuries as~     experienced by patients.~   "
249584|NCT00285623|"~     The purpose of this study is to collect information, after exposure to TachoSil ®, of all~     thromboembolic events, immunological events and drug interactions leading to thromboembolic~     events or major bleeding. In addition, pharmacoeconomic data will be collected.~   "
249585|NCT00285610|"~     Prior research indicates a link between early lead exposure and risk for delinquent behavior.~     In this study, we follow a large birth cohort from the Cincinnati Lead Study into early~     adulthood to determine whether this increased risk persists. Outcome measures include~     official arrest records, diagnoses of Substance Abuse Disorder and Antisocial Personality~     Disorder, self-report of delinquent behavior, and a psychopathy scale. Predictors include~     pre-natal and post-natal blood lead levels. Multivariate statistical methods will control for~     potential confounders/covariates.~   "
249586|NCT00285597|"~     This is a double-blind, placebo-controlled, cross-over study evaluating the effects of UDCA~     on peripheral blood flow and immune function in patients with stable chronic heart failure~     (CHF). Sixteen patients with CHF will be recruited from the heart failure clinic at the Royal~     Brompton Hospital. Following baseline evaluation, patients will be randomised to receive~     either placebo or UDCA at a dose of 1000 mg/day for a period of four weeks. They will then~     undergo repeat evaluation (peripheral blood flow and immune function). A four week washout~     period will then take place before the patients cross-over to receive the respective other~     therapy for a further four weeks (i.e. those first receiving placebo will go onto receive~     UDCA and vice versa). The study will be completed after a total of twelve weeks, with a final~     assessment (peripheral blood flow and immune function).~   "
249587|NCT00285584|"~     The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons~     with mild-to-moderate depression would be more likely to adopt protective behavior change~     when provided with pharmacotherapy for their depression than when treated with placebo.~     High-risk behaviors include using illegal drugs and participating in unprotected sexual~     intercourse. The specific pharmacotherapy used in this study was the anti-depressant,~     bupropion. The subject population consisted of HIV negative men who have sex with men (MSM)~     with mild-to-moderate depression.~   "
249588|NCT00285571|"~     The relative importance of dietary patterns vs. macronutrient composition in affecting energy~     intake and body weight remains uncertain. In this study we propose to investigate the~     relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. We~     will quantify and compare the effects of typical ranges of variety & fat intakes in the~     American diet on voluntary energy intake. The primary hypotheses to be tested are 1)an~     increasing availability of entree/side/snack/dessert variety offered will significantly~     increase voluntary energy intake in a dose-response fashion when other dietary factors known~     to influence energy intake are held constant. 2)The separate effects of dietary variety &~     dietary fat on energy intake will be similar.~      We anticipate that the results of this investigation will lead to a greater understanding of~     the relative importance of eating patterns versus macronutrient composition in the etiology~     of obesity, and more specifically, dietary variety versus dietary fat in determining energy~     intake. More importantly, it will help lay a foundation for improved dietary recommendations~     concerning weight loss and prevention of excess weight gain in adulthood.~   "
249589|NCT00285558|"~     The purpose of this study is to determine whether adding a peer-based intervention based on~     an outward bound model is more effective than a standard behavioral weight intervention for~     helping adolescents lose weight.~   "
249795|NCT00282802|"~     The purpose of this study is to examine the role of genetic and environmental factors in the~     cause of Parkinson's disease.~   "
249591|NCT00285532|"~     The purpose of this project is to help families and communities identify and reduce health~     risks from lead, pesticides and, ultimately, other environmental hazards. We have partnered~     with the Better Housing League and Baby's Milk Fund in Cincinnati and nationally with the~     Alliance to End Childhood Lead Poisoning and the National Center for Lead Safe Housing. The~     first specific aim of this project is to evaluate a sampling kit for families to assess~     levels of lead and pesticides in their home environment. This aim will strengthen~     right-to-know laws by providing families with tools to assess environmental contamination in~     their own homes. The second aim is to increase community awareness of the role of~     environmental agents in developmental disorders, hearing loss and school problems.~   "
249592|NCT00285519|"~     The purpose of this study is to examine whether strict blood pressure (BP) control by~     doxazosin using home BP monitoring, especially targeting the morning BP level, can reduce~     hypertensive target organ damage.~   "
249593|NCT00285506|"~     The purpose of the study is to test the effect that contrast media (dye) has on cellular~     integrity (structure)~   "
249594|NCT00285493|"~     Clinical trial using antibiotic treatment, namely Rulid, after onset of low back pain.~   "
249595|NCT00285467|"~     The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and~     4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control~     hyperparathyroidism in this group is unknown. The National Kidney Foundation presented~     guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients~     and active vitamin D therapy in patients with sufficient levels. These guidelines are based~     on opinion since there are no significant trials to determine if vitamin D supplementation is~     effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol,~     and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have~     not been compared with vitamin D supplementation with a calciferol (ergocalciferol or~     cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in~     vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood~     pressure and strength. In this proposed study we wish to directly compare the effectiveness~     of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with~     CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary~     endpoints will be change in blood pressure.~   "
249596|NCT00285454|"~     Many people in the UK have ischaemic heart disease. Insufficient blood supply to the heart~     muscle means that it functions inefficiently, and leads to symptoms of shortness of breath,~     chest pain and excess fluid in the body. Recently it has been shown that cells from the~     inside of bone are able to produce many different cell types. We are investigating a new~     treatment in which a patient's bone marrow cells are taken, and injected into the heart in an~     attempt to produce new blood vessels and heart muscle cells. This may lead to a new treatment~     for ischaemic heart disease.~   "
249597|NCT00285441|"~     The purpose of this study is to identify differences in TB specific immune responses among~     immunosuppressed patients latently infected with TB and patients with active TB.~   "
249598|NCT00285428|"~     This is a Phase I trial to look at safety and how a patient's body will tolerate the~     treatment at different dosages.~   "
249599|NCT00285415|"~     The purpose of this study is to determine the effectiveness of the combination of the two~     drugs, docetaxel (Taxotere®) and carboplatin (Paraplatin®) followed by radiation directed at~     the tumor in treating your endometrial cancer.~   "
249600|NCT00285402|"~     The purpose of this migraine prevention study is to evaluate the efficacy and safety of~     AST-726 in moderate to severe migraine patients at one of two doses compared to placebo and~     compared to a baseline period as measured by a reduction in the number of migraine days.~   "
249601|NCT00285389|"~     Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C~     (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients~     under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow~     purge with rituximab before an autologous stem cell transplantation for the consolidation of~     the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.~   "
249602|NCT00285376|"~     This study is designed to determine the safety and effectiveness of vilazodone for major~     depressive disorder and to discover genetic markers associated with response. This study will~     enroll approximately 400 patients.~   "
249603|NCT00285363|"~     This descriptive study aims to allow children and adolescents who have cancer to~     self-evaluate their quality of life. It is hypothesized that treatment affects quality of~     life in the areas of physical and social functioning. It is further hypothesized that these~     effects dissipate within 6 months after treatment is completed.~   "
249604|NCT00285350|"~     This is a prospective, multi-center, double-blind, placebo-controlled trial to determine the~     efficacy and safety of mycophenolate mofetil (MM) in combination with prednisone as the~     initial form of immunosuppression in patients with acquired myasthenia gravis (MG).~   "
249605|NCT00285337|"~     The primary purpose of this study is to compare anterior and posterior surgical approach in~     treatment of CSM in terms of surgical complications and neurological, functional,~     disease-specific and quality of life outcomes measures.~      Secondary aims are to quantify the amount of change pre and post-surgery concerning the same~     outcome measures; to determine if there are differences in outcomes between posterior~     surgical techniques (i.e. laminectomy with fusion or laminoplasty) and examine the~     relationship between baseline MRI and baseline and follow-up neurological and functional~     outcomes.~   "
249637|NCT00284895|"~     This research study is looking at the effects of weight loss, due to surgery or structured~     weight-loss program on lung function, inflammation in your body and lungs, asthma and asthma~     symptoms. This study is important because we will be better able to understand the effect of~     weight on lung functioning and asthma. Approximately 20 research subjects will be enrolling~     in this study at National Jewish.~      Adults with asthma who has elected to undergo weight-reduction surgery may qualify for the~     participation. Involvement will last about 1 year.~   "
249698|NCT00284089|"~     Open-label Multicenter, Phase I/II Study comprising three phases (single dose, multiple dose~     and extension phase), Assessing the Safety and Efficacy of Ranibizumab (RFB002) in Japanese~     Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular~     Degeneration (AMD).~   "
249606|NCT00285324|"~     This study will examine the use of a variation of standard magnetic resonance imaging (MRI)~     called diffusion tensor MRI (DT-MRI) for distinguishing injured brain tissue due to radiation~     therapy (radiation necrosis) from the return of a brain tumor that was previously removed~     (tumor recurrence). DT-MRI differs from standard MRI in the way that computers process the~     images; there is no difference in the experience of having the procedure done. Both radiation~     necrosis and tumor recurrence can occur within weeks to months following brain radiation~     treatment. Because the treatment and management options for the two conditions differ~     significantly, distinguishing the two is of critical importance. Currently, surgical biopsy~     is required to make this differentiation.~      Healthy volunteers and patients who have received radiation therapy as part of their~     treatment for a brain tumor may be eligible for this study. All candidates must be at least~     21 years old. Patients must have a new area of abnormality that requires a biopsy to~     determine whether it is a tumor recurrence or radiation necrosis. Candidates are screened~     with a medical history and physical examination. In addition, patients have blood and urine~     tests.~      All participants undergo MRI and DT-MRI. MRI uses a strong magnetic field and radio waves~     instead of X-rays to obtain images of body organs and tissues. The MRI scanner is a metal~     cylinder surrounded by a strong magnetic field. During the MRI, the subject lies on a table~     that can slide in and out of the cylinder and wears earplugs to muffle loud knocking noises~     that occur during the scanning. Scanning time varies from 20 minutes to 3 hours, with most~     scans lasting 40-60 minutes. Subjects may be asked to lie still for up to 20 minutes at a~     time. DT-MRI is a type of MRI that measures how water moves in the brain tissue. This~     technique uses the same MRI machine as conventional MRI, but the diffusion images are~     obtained after the normal MRI scan, and by a computer program that is installed into the~     machine. This completes the participation of healthy subjects.~      In addition to the scans, patients undergo brain biopsy of the abnormal areas identified by~     MRI. Patients' commitment to the study protocol is fulfilled when the surgery is complete;~     they may, however, continue to receive follow-up care at the NIH Clinical Center after they~     complete the study. They are given the results of the biopsy so that further treatment, if~     necessary, can be arranged.~   "
249607|NCT00285298|"~     The purpose of the investigators study is to assess the impact of therapy with Pentoxifylline~     (PTF), a nonspecific phosphodiesterase inhibitor, on kidney function in patients at high-risk~     for progression to end-stage renal disease. The investigators hypothesize that therapy with~     Pentoxifylline will slow progression of kidney disease over time.~   "
249608|NCT00285285|"~     To compare the effect of “point-of-care” (POC) analysis of blood work with traditional~     laboratory methods on length of stay in a pediatric emergency department (PED).~   "
249609|NCT00285259|"~     The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs~     (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just~     before and after transplantation) and CMV-seropositive recipient-only subjects (related or~     unrelated) to determine incidence rates of CMV infection, disease, and other complications~     from immunosuppression and/or transplantation. The outcomes for the groups receiving CMV~     vaccine will be compared to the outcomes for the group that received the placebo vaccine to~     see if there is a clinical benefit. For this trial, donors and recipients must have matched~     HLA genotype (matched at 5/6 or 6/6 HLA loci).~   "
249610|NCT00285246|"~     Background: Previous deployments like that to the Persian Gulf in 1991 produced veterans with~     post-deployment symptom-based health problems with no medical explanation. This was termed~     Gulf War illness or medically unexplained illness (MUI). If previous wars are any indication,~     some soldiers currently deployed to hostile areas also will return home with unexplained~     symptom-based illnesses. However, when this study began there was virtually no pre-war,~     prospective data on risk and resilience factors associated with MUI. This study is attempting~     to fill that gap.~      Objectives: Our goals are to: (a) determine pre- and immediate post-deployment factors~     predicting later MUI and poor functional status, (b) improve previous methodological problems~     (e.g., selection bias, recall bias and lack of baseline controls) in studies of MUI, and (c)~     relate pre-deployment risk factors (e.g., personality, stressor reactivity) and resilience~     factors (e.g., coping style, social support) to post-deployment functional status.~   "
249611|NCT00285233|"~     The objective of this study is to assess the safety and efficacy of islet allotransplantation~     for the reestablishment of stable glycemic control in patients with type 1 diabetes, using~     anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and~     low dose tacrolimus maintenance immunosuppression.~   "
249612|NCT00285220|"~     This two site study will evaluate the safety and effectiveness of laparoscopic truncal~     vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.~   "
249613|NCT00285207|"~     A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous~     cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the~     safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.~   "
249614|NCT00285194|"~     The collective effects of two-layer pancreas preservation, pretransplant islet culture, day~     -2 pretransplant immunosuppression, and induction immunosuppression with the FcR-nonbinding~     anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala)to facilitate diabetes reversal after~     single-donor islet transplantation.~   "
249615|NCT00285181|"~     To evaluate the effects of a 8-week treatment with 80 mg/day simvastatin on prooxidant and~     antioxidant status at rest and after exercise, on mitochondrial respiration and calcium~     release in skeletal muscle, and on aérobic aptitude in 24 healthy male subjects.~   "
249616|NCT00285168|"~     This research study is being conducted to determine if a modified bone mineral density (BMD)~     test report that contains additional fracture risk information will be a useful physician~     decision aide in selecting patients for pharmacological osteoporosis therapy. It is~     hypothesized that this supplementary information, provided in addition to the conventional~     BMD report, will increase the likelihood that patients at high risk for an osteoporotic~     fracture will receive prescribed therapy for osteoporosis.~   "
249617|NCT00285155|"~     To evaluate the effects of a 14-day repeated dose of 150 mg bupropion (therapeutic dose) on~     cognitive and executive functions, behaviour and subjective feelings, after sleep deprivation~     in 12 healthy male subjects.~   "
249618|NCT00285142|"~     To evaluate :~        -  acute effects of a single dose of 8 mg rosiglitazone (therapeutic dose)~        -  on insulin secretion and~        -  insulin sensitivity in 12 healthy male subjects.~   "
249619|NCT00285129|"~     Comparison of the functional result and speed of rehabilitation between two types of hip~     prostheses: primary ceramic-on-ceramic total hip replacement versus metal-on-metal hip~     resurfacing.~   "
249620|NCT00285116|"~     Comparison between 3 groups:~        -  group I has hallux rigidus. Is fasicitis plantaris present?~        -  group II has fasicitis plantaris. Does the hallux have limited mobility?~        -  group III does not have hallux rigidus or fasicitis plantaris~   "
249621|NCT00285103|"~     The purpose of this study is to determine whether SPC2996 is effective and safe in the~     treatment of Chronic Lymphocytic Leukaemia (CLL)~   "
249654|NCT00284674|"~     This evaluation is being conducted to evaluate the performance of thee prosthesis.~   "
249622|NCT00285090|"~     The purpose of this study is two-fold. The first is to establish that bone mineral density is~     diminished among children admitted to this regional burn center as compared to healthy~     non-burned children. The second purpose of this study is to examine the short and long-term~     effects of calcium and vitamin D supplementation in on bone metabolism and accrual in~     children who have been burned.~      Specific Aims: 1) To measure bone mineral content and bone mineral density and their change~     during growth in convalescent burned children admitted to a regional burn center and to~     compare them to normal, healthy children.; 2) To measure lean body mass, fat mass, total body~     water in convalescent burned children admitted to a regional burn center and compare them to~     normal, healthy children with focus on how these components of body composition relate to~     indices of bone mineral content and density; 3) To identify alterations in bone metabolism~     and calcium and vitamin D homeostasis following burn injury and relate these to bone mineral~     density in burned children; 4) To test the effect of short term calcium and vitamin D~     supplementation on improving bone mineral density, bone mineral content, and indices of~     calcium and vitamin D metabolism in acutely burned children.~   "
249623|NCT00285077|"~     The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B~     in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD).~      A secondary objective is to describe the long term progression of Alzheimer's symptoms in~     patients treated by 4 mg/day of SR57667B.~   "
249624|NCT00285064|"~     To perform a comprehensive evaluation of multidetector CT myocardial enhancement patterns in~     patients with an acute ST elevation MI. In particular we plan to assess the relationship~     between regions with early hypoperfusion and/or late hyperenhancement, and myocardial~     viability.~   "
249625|NCT00285051|"~     Patients will be treated for 2 consecutive chemo cycles with the study drug for one and~     placebo for the other. In addition, patients will receive an injection before the chemo,~     either ondansetron (if receiving placebo inhalation) or normal saline) if receiving active~     study drug. They will take study medication for 3 days, 4 times daily and fill out VAS scores~     before and after doses. Patients will be given rescue medication with each dose.~   "
249626|NCT00285038|"~     The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT~     detected by Doppler ultrasound in a selected group of patients suffering from gynecological~     malignancies.~   "
249627|NCT00285025|"~     The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison~     to placebo, decreases the decline in cognitive performance and the global clinical decline~     over 1 year in patients with mild to moderate AD.~      Secondary objectives are to assess the effect of SR57667B on functional decline and its~     safety/tolerability in patients with mild to moderate AD, and to document plasma~     concentrations of SR57667 in patients with mild to moderate AD.~   "
249628|NCT00285012|"~     This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette~     smokers with the intent of demonstrating differences in smoking cessation between varenicline~     and placebo.~   "
249629|NCT00284999|"~     To determine the ocular efficacy and safety of Soothe and Refresh Tears.~   "
249630|NCT00284986|"~     This study is designed to evaluate the safety and efficacy of Prochymal(TM) (Ex-vivo Cultured~     Adult Human Mesenchymal Stem Cells) in subjects experiencing treatment-refractory acute GVHD,~     Grades III-IV, that is refractory to standard first line therapies and at least one~     second-line therapy.~   "
249631|NCT00284973|"~     Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate,~     PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and~     immunogenicity of 3 doses and 2 vaccination schedules.~      This blood stage candidate malaria vaccine is being developed for the routine immunization of~     infants and children living in malaria-endemic areas.~   "
249632|NCT00284960|"~     Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance~     compared to healthy controls.~   "
249633|NCT00284947|"~     The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney~     transplantation is associated with renal dysfunction and hypertension. The study will~     evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab~     at monthly doses.~   "
249634|NCT00284934|"~     This study introduces a new optimization immunosuppressive regimen associating tacrolimus at~     a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow~     down renal function worsening and to prevent the progression of chronic allograft~     nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.~   "
249635|NCT00284921|"~     To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the~     clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison~     with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests~     (ALT/AST) after 12 months treatment.~   "
249636|NCT00284908|"~     S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a~     class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially~     available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers,~     erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study~     evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid~     suppression is considered to be correlated with clinical efficacy.~      In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each~     volunteer. First, one of the dosages will be orally administered for five days. Then, a nine~     to sixteen day period without study drug administration will follow prior to the~     administration of the next dosage, for again five days. Each volunteer will have a total of~     four study drug administration periods.~      After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be~     done for four days. After the last study drug intake in period 4 pharmacokinetic blood~     sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood~     draws over a pre-determined time period. The pharmacokinetic blood sampling measures the~     medication concentration in the blood at pre-defined time points.~      After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured~     for 24 hours by means of a thin tube that will be inserted into the stomach through the~     nostril to evaluate the efficacy of the different dosages of STU-Na.~   "
249638|NCT00284882|"~     The purpose of this study is to find out how often group A Streptococcus (GAS) occurs in~     school-age children of Central Fiji. This bacterium often causes pharyngitis (sore throat)~     and can also cause pyoderma (skin infection) or scabies. Approximately 1000 children ages~     5-14 years will be enrolled from 4 primary schools in Central Fiji. These children will have~     throat swabs performed to determine how commonly GAS occurs. Over the next 10 months,~     children in this group who complain of sore throat will be examined and have throat swabs to~     determine if GAS is the cause. A subset of 600 children will be examined for pyoderma and~     scabies and have throat swabs every 2 months during the 10 month study. In addition, a small~     amount of blood will be drawn at 0, 6, and 10 months to determine the level of antibodies to~     Streptococcus.~   "
249639|NCT00284869|"~     The purpose of this study is to investigate putative ethnic differences in the~     proinflammatory response in human endotoxemia.~   "
249640|NCT00284856|"~     This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in~     participants with chronic asthma who actively smoke cigarettes.~   "
249641|NCT00284843|"~     The purpose of this study is to estimate the number of cases of rheumatic heart disease,~     pyoderma, and scabies in school age children in Fiji. In addition the study will describe the~     features of rheumatic heart disease, pyoderma, and scabies in these children. Study~     participants will include 5200 primary school children, ages 5-14, from 21 primary schools in~     the Central Division of Fiji. These children will be examined for pyoderma, scabies, and the~     doctor will listen to their heart with a stethoscope. Any child that has a heart murmur~     detected will have their heart looked at through an echocardiogram test (uses sound waves to~     create a picture of how the heart is working). Any child that is found to have rheumatic~     heart disease will be referred to a pediatric cardiologist for further evaluation.~     Participants will be involved in the study for about 2 days.~   "
249642|NCT00284830|"~     SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main~     objective to study the effect of unnecessary right ventricular apical pacing on the clinical~     outcome of time to development of persistent AF.~   "
249643|NCT00284817|"~     - Assess the safety and tolerance of a weekly MEDI522 regimen in patients with~     irinotecan-refractory advanced CRC or other solid tumors refractory to standard therapy.~   "
249644|NCT00284804|"~     This study is designed to determine the objective response rate in patients with relapsed or~     refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or~     gemcitabine alone.~   "
249645|NCT00284791|"~     The primary hypothesis of this study is that in fluoxetine (Prozac)-resistant adolescents~     with Major Depressive Disorder (MDD), Lamotrigine plus fluoxetine will be safe and as~     effective as sertraline (Zoloft).~      Our Primary Aim is to determine the efficacy and safety of Lamotrigine-augmentation of~     fluoxetine for treatment-resistant depression in adolescents.~      Our Secondary Aims are to characterize the factors associated with treatment-resistance for~     adolescents with major depression. Also to assess the relationships in the families of~     adolescents with major depression as they enter treatment, and to track the differences in~     family relationships for adolescents who respond or do not respond. We postulate that tense,~     frustrated, irritable, and over-involved relationships constitute a risk factor for~     attenuated improvement or relapse.~   "
249646|NCT00284778|"~     The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer~     is now well established. The two treatments of reference are pemetrexed (alimta) and~     docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in~     the literature.~      Economic analyses are currently one of the criteria used in medical decision, beside~     effectiveness, quality of life and toxicities.~      However, Economical comparison shows significant variations in the acquisition costs of the~     two drugs. Consequently, it appears interesting to carry out a randomized prospective study~     with on exclusive economical criteria of judgment.~      As there is no difference in the effectiveness between the two treatments, a~     cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an~     economical point of view (payer).~   "
249647|NCT00284765|"~     The purpose of this trial is to study the management of the sprained ankle by help of~     NSAID-plaster. A questionnaire. The effect of RICE and RICE + NSAID-plaster in the treatment~     of the sprained ankle, compared by pain-score.~   "
249648|NCT00284752|"~     Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone~     refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response~   "
249649|NCT00284739|"~     Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will~     reduce the duration of percutaneous drainage and increase the proportion of successful~     drainages.~   "
249650|NCT00284726|"~     The purpose of this study is to compare 2 different cold storage solutions, used to preserve~     donor lungs for lung transplantation, and their effect on cytokine activation related to~     ischemic reperfusion injury. Primary endpoint is 30 day survival.~   "
249651|NCT00284713|"~     Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with~     non ischemic dilated cardiomyopathy.~   "
249652|NCT00284700|"~     Helicobacter pylori is recognized as a major gastrointestinal pathogen in developing~     countries. This microorganism infects up to 60% of children less than five years in those~     countries and is strongly associated with chronic gastritis and peptic ulcer disease in~     children and adults. The progression of gastritis to atrophy often leads to decreased gastric~     acid output, which is a well-known risk factor for anemia. Gastric acid is essential for~     increasing the bioavailability and absorption of non-heme dietary iron, the most important~     source of iron in developing countries. Numerous reports suggest that iron malabsorption~     secondary to low gastric acid output is a problem in developing world countries. It has been~     further observed that iron deficiency anemia is resistant to iron therapy particularly in~     these countries. In a recently completed study we observed an association of anaemia with H.~     pylori infection. We hypothesize that the poor bioavailability of iron in these countries~     could be related to H. pylori -induced low gastric acid output and we propose to investigate~     the role of H. pylori infection as a cause of anemia and treatment failure of iron~     supplementation in Bangladesh. A prospective, randomized, double-blind, placebo-controlled~     field trial is proposed among four groups ( 65 each) of H. Pylori infected children of 2-5~     years of age with iron deficiency anemia. The children will be assigned to one of the four~     therapies: antibiotics alone (for H. Pylori eradication), antibiotic plus iron therapy, iron~     therapy alone, or placebo. Hemoglobin concentration, serum ferritin concentration, and~     transferrin receptor will be measured before and at 1 and 3 month after the intervention. We~     also propose a complementary study in an additional 20 children with H. Pylori infection and~     iron deficiency anemia to assess iron absorption with application of double stable isotopes.~     The change in hematological parameters will also be compared among the groups before and~     after the therapy. The results of this study are expected to have implications in the~     prevention and treatment of iron deficiency anemia in developing countries.~   "
249653|NCT00284687|"~     Human cytomegalovirus (HCMV) has remained a major cause of morbidity and mortality following~     allogeneic bone marrow or peripheral blood stem cell transplantation (SCT). The most reliable~     virological predictive marker for disease development is the presence of HCMV viremia. It has~     been further recognized that viral load, and viral load kinetics are important determinants~     of pathogenesis. Prior to the preventive use of antiviral agents, CMV disease occurred in~     15-45% of at-risk patients and carried a high mortality rate. In the last decade, major~     advances in the prevention of CMV disease have occurred with the application of pp65~     antigenemia and qualitative/quantitative polymerase chain reaction (PCR) assays for the rapid~     and sensitive diagnosis of HCMV infection, combined with preemptive antiviral treatment~     targeted to patients with viremia. The prevalence of early CMV disease has declined to 3% to~     6% with intense antiviral drug use. All antiviral drugs currently used for the treatment of~     systemic HCMV infection, including ganciclovir, foscarnet, and cidofovir, target the HCMV DNA~     polymerase. Ganciclovir is the most widely used drug for preemptive treatment. However,~     ganciclovir treatment is often complicated by bone marrow toxicity with the occasional~     development of potentially life-threatening thrombocytopenia, granulocytopenia, and graft~     failure, associated with secondary bacterial and fungal infection. Another limitation of~     preemptive ganciclovir therapy is the requirement for intravenous administration. The~     currently available oral valganciclovir is not yet approved for preemptive therapy in SCT~     recipients, and is associated with high treatment cost. Additionally, prolonged or repeated~     ganciclovir treatment may lead to the development of drug resistance. The use of foscarnet~     and cidofovir is limited by considerable nephrotoxicity, low oral bioavailability, and high~     cost. Thus, there is an increasing need for new effective non-toxic, low-cost anti-HCMV drugs~     with high oral bioavailability.~      Recently, the anti-malaria drug artesunate, which is widely used in the treatment of severe~     malaria, has been shown to be a highly effective inhibitor of HCMV in vitro. Artesunate~     exhibited similar antiviral activity (same micromolar range) to that of ganciclovir, while~     demonstrating no cytotoxicity. Importantly, its antiviral activity has been further~     demonstrated in vivo in a rat CMV model. No significant side effects were demonstrated in a~     number of pre-clinical and clinical studies, and artemisinin and its derivatives have been~     shown to be well-tolerated and safe in adults and children. Several million people have taken~     artemisinins to date, with no significant adverse or treatment-limiting effects being~     reported. Although neurotoxicity has been reported with supraphysiological doses in animals,~     it has not been documented in humans. Meta-analyses of malaria patients treated with~     artemisinins demonstrated that this drug class is safe. In rare cases, however, slight~     changes to haematology values have been seen, including a reduction in the number of~     reticulocytes as well as a slight increase in transaminase levels. These signs, however, do~     not generally give rise to any noticeable clinical manifestations. In rare cases, a slight~     but transient reduction in sinus heart rate has been observed. Abdominal cramps and mild~     diarrhoea have been reported at elevated doses.~      Thus, one might expect a similarly high degree of safety for the potential use of artesunate~     as an antiviral drug for HCMV infection. Thus, oral therapy with artesunate could be a~     beneficial option to the current therapies for the preemptive treatment of HCMV disease in~     SCT recipients.~   "
249655|NCT00284661|"~     Meniscal repair resulting in meniscal preservation is the most desirable treatment of a torn~     meniscus and is one of the most commonly performed arthroscopic procedures. The inside-out~     meniscal suturing technique allows precise placement of sutures under direct visualization~     and studies have reported excellent healing rates and low re-tear rates. However,~     complications associated with the use of the inside-out technique (injury to the knee's~     neurovascular structures and infection) and the fact that it is a time consuming procedure~     have generated the development of alternative methods and devices. The FasT-Fix is reported~     to be quicker and safer. It is applicable to tears in most locations and requires no~     additional incisions or portals. Even though this and many similar devices are widely used~     with reported clinical healing rates of 75 -92% and relatively minor complications, few~     prospective, randomized clinical trials evaluating and comparing different techniques have~     been carried out. Patient outcome studies are necessary to evaluate which technique~     ultimately results in the most effective repair and the least patient disability following~     surgery.~      We hypothesize that an inside-out suturing technique will have a higher complication rate but~     a significantly lower failure rate than the FasT-Fix Menisical Repair System~   "
249656|NCT00284648|"~     This study is intended to determine whether the optimal treatment of acute Achilles tendon~     ruptures is surgical repair or functional bracing.~      Our hypotheses are surgical repair will: 1) Result in a clinically relevant decrease in~     re-rupture rate and 2) Result in a clinically relevant improvement in disease specific~     quality of life and 3) A clinically relevant improvement in functional outcome measures~   "
249657|NCT00284635|"~     The purpose of this study is to see if it is possible to discharge patient undergoing a UKA 1~     day postoperatively~   "
249658|NCT00284622|"~     It remains unknown if a concomitant arthroscopic knee debridement would increase the benefits~     of surgery (quality of life and functional ability) for young active patients with medial~     compartment OA of the knee and varus alignmen. This additional procedure has a low incidence~     of morbidity and would potentially allow for treatment of meniscal tears and articular~     damage, as well as joint lavage to remove debris and inflammatory factors. A trial is needed~     to determine whether HTO with concomitant knee arthroscopy will result in better overall~     outcomes for this patient group.The objective is to compare the quality of life, functional~     status, pain, and swelling of patients who undergo an HTO with or without a concomitant knee~     joint arthroscopy to address additional joint pathology~   "
249659|NCT00284609|"~     The aim of this study is to investigate the effect of a new rehabilitation program of type 2~     diabetes patients in a primary care center versus standard care in the outpatient Hospital~     Clinic.~   "
249660|NCT00284596|"~     Patients undergoing opening wedge high tibial osteotomy (HTO) will be randomized to standard~     or locking screw fixation of the osteotomy plate. Tantalum beads will be implanted around the~     osteotomy site in all subjects to facilitate RSA imaging which will then allow micromotion at~     the osteotomy site to be quantified.~      Primary Objectives and Hypothesis~        1. a)to determine fixation stability of the Puddu opening wedge osteotomy plate secured~          with non-locking compared to locking screws. We hypothesize that plate fixation with~          locking screws will result in a significant reduction of micromotion between tibial~          segments prior to bony healing compared to the non-locking screw fixation.~           b)To determine the progress of bony healing. We hypothesize that increased fixation~          stability in patients with locking screws will facilitate early bone healing reflected~          by smaller micromotion over time compared to the non-locking screw patients.~        2. a)If there is improved stability with the use of locking screws, rehabilitation~          protocols following opening wedge HTO will be modified accordingly. We hypothesize that~          decreasing micromotion will reach the detection limit of the RSA setup (0.4 mm) earlier~          in the locking screw group than in the non-locking screw group.~           b)To evaluate the effect of the osteotomy on proximal tibial anatomy. We hypothesize~          that an open-wedge procedure might increase rather than decrease the tibial slope.~   "
249661|NCT00284583|"~     Interdigital neuroma is a painful forefoot disorder characterized by plantar pain and toe~     paresthesias thought to result from entrapment of the interdigital nerve by the overlying~     transverse metatarsal ligament. Multiple treatments have been recommended for this condition~     and range from modification of shoe wear to surgical excision of the painful nerve. Serial~     ethanol injection therapy has been reported to be an effective alternative to surgical~     excision. However, despite wide adoption of this treatment, no randomized, double blinded,~     placebo-controlled study exists to verify the efficacy of this treatment in comparison to~     longer standing similar therapies, such as corticosteroid injection.~      120 patients from one Orthopaedic group’s foot and ankle offices with single foot neuromas~     and no previous history of neuroma or foot disorder treatment will be selected for the study.~     These patients will be randomized to three treatments, specifically lidocaine injection,~     corticosteroid injection, or ethanol injection. Outcomes will be assessed at 3, 6 and 12~     month time points using validated questionnaires as well as a non-validated disease specific~     questionnaire. Primary endpoint will be graded change in the physical function portion of the~     SF-36 form. Secondary endpoints will be the graded change in the McGill Short Form for Pain~     and ultimate satisfaction with treatment as assessed by a non-validated questionnaire~     designed for Morton’s neuroma symptoms.~   "
249662|NCT00284570|"~     First, we, the researchers, hope to find out the PCT response to heart surgery in children by~     taking blood before surgery and each day for four days after surgery. These blood draws will~     help us figure out the typical Procalcitonin (PCT) response, the normal increase in PCT after~     heart surgery, and when the PCT level returns to baseline.~      Second, we, the researchers, hope to determine the accuracy of PCT as a marker of infection.~      Hypothesis~      Our hypothesis is that Procalcitonin is superior to other currently used markers of infection~     and will prove to be a clinically useful tool for evaluation of infection in children~     following cardiac surgery.~   "
249663|NCT00284557|"~     The purpose of this study is to determine whether participation in a group-based health~     education curriculum is superior to receipt of standardized health educational materials for~     children who are overweight or at risk for overweight with regard to achievement of a~     healthier body weight and improvement of key eating and physical activity behaviors.~   "
249699|NCT00284076|"~     To assess the effects of L-arginine upon functional status (treadmill exercise testing;~     quality of life) and limb blood (by mercury strain gauge plethysmography) in peripheral~     arterial disease.~   "
249664|NCT00284531|"~     This protocol is designed to obtain information on the drug levels, metabolism, and safety of~     daclizumab (Zenapax(R)) in children and adolescents undergoing cardiac transplantation. In~     addition to the drug safety and metabolism information, the number and severity of rejection~     episodes in patients undergoing cardiac transplantation using the standard immunosuppressive~     drugs plus daclizumab will be compared with patients who have previously undergone cardiac~     transplantation at the Baylor College of Medicine and received the same standard~     immunosuppressive drugs without daclizumab.~   "
249665|NCT00284518|"~     The purpose of this study was to determine the safety and effectiveness of different doses of~     botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic~     hyperplasia.~   "
249666|NCT00284505|"~     This pilot study will evaluate whether thalidomide decreases pain in patients with~     arachnoiditis.~   "
249667|NCT00284492|"~     In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care~     decreases the frequency of hot flushes and increases health related quality of life among~     postmenopausal women. The intervention group will receive 10 sessions of acupuncture, the~     control group will engage in self care only. The study period lasts for 12 weeks.~   "
249668|NCT00284479|"~     The purpose of this study was to investigate the effects of an 8 week program of walking for~     45 minutes, twice a week, on fitness, body composition , blood pressure and blood markers of~     cardiovascular risk. We hypothesised that this 90 minutes of walking per week would result in~     measurable increases in fitness and reductions in body fat, resting blood pressure and~     improved blood lipid profiles.~   "
249669|NCT00284466|"~     The purpose of the study is to compare the pictures of heart arteries obtained by MSCT~     scanner to the pictures obtained during heart catheterization. Our specific question is~     whether the MSCT scanner is accurate enough to replace heart catheterization in some~     situations for the evaluation of coronary heart disease.~   "
249670|NCT00284453|"~     The purpose of the proposed pilot study is to identify factors which are associated with~     periods of high ventricular arrhythmia burden. This will be performed by analysis of gene~     expression from peripheral blood samples.~   "
249671|NCT00284440|"~     The present study is designed to compare the response of choroidal blood flow to the~     hand-grip test in glaucoma patients with and without visual field progression.~   "
249672|NCT00284427|"~     It is known that people with cancer are using antioxidant vitamins at high rates. It is not~     known if these vitamins are safe to use during cancer treatment. It is not known if common~     vitamins and minerals used by many cancer patients will interfere with cancer treatments by~     reducing the effectiveness of the cancer therapy. Preliminary studies that look at the~     addition of antioxidants during cancer therapy show us that antioxidants could play a~     significant role in the management of cancer.~      Antioxidants are vitamins and other nutrients that help to decrease inflammation in the body~     by stopping free radicals or oxidants. Common antioxidants include vitamins E, C, and A,~     beta-carotene, and glutathione. Some doctors who treat cancer are now using antioxidants with~     chemotherapy while others believe they should not be used with cancer treatment.~      The purpose of this study is to try and understand if it is safe efficacious to add~     antioxidant nutritional supplements to traditional chemotherapy and/or radiation therapy~     during the treatment of cancer.~   "
249673|NCT00284414|"~     Patients with Morton neuroma of the foot will undergo either ultrasonography or MRI. The~     results will be compared.~      In case of surgery, the pathology report will be compared with the ultrasonographic or MRI~     findings.~      Which is the most reliable and specific: ultrasonography or MRI?~   "
249674|NCT00284401|"~     Comparison of the function and mobility of the shoulder with the placement of the Delta~     prosthesis (anteversion and retroversion of the glenoidal and humeral components)~   "
249675|NCT00284388|"~     Development of a non-invasive method for the determination of the position of optimal muscle~     length in the different muscles of the shoulder.~      Analysis of the adaptation of the muscle to a new optimal length in patients with a shoulder~     prosthesis.~   "
249676|NCT00284375|"~     Systematic registration of all big toe prostheses placed in Ghent University Hospital for~     analyses of global results, comparison between different types of prostheses, ...~   "
249677|NCT00284362|"~     Comparison between arthroscopic and open surgery for hallux rigidus.~   "
249678|NCT00284349|"~     Comparison between immobilisation by a plaster and a rehabilitation brace for the treatment~     of a fracture of the ankle~   "
249679|NCT00284336|"~     This is an open label Phase II study in elderly patients (65y or older) with early breast~     cancer who are candidate for adjuvant chemotherapy. A scheme with liposomal doxorubicin~     (Caelyx) and cyclophosphamide (endoxan) will be used. The aim is to study the cardiac effects~     of liposomal doxorubicin with new non-invasive techniques, ie strain rate imaging, classical~     echocardiography, and special blood tests measuring troponin I and BNP.~   "
249680|NCT00284323|"~     Investigate the effect of selective intracoronary administration of adenosine on myocardial~     salvage and microvascular integrity in the setting of acute myocardial infarction.~   "
249681|NCT00284310|"~     The purpose of this trial is to follow-up on patients who underwent different types of wrist~     surgery: 4-row arthrodesis or proximal row carpectomy.~   "
249682|NCT00284297|"~     Follow-up of patients who underwent a knee arthrodesis with different types of intramedullary~     nails.~   "
249683|NCT00284284|"~     Comparison of the added value of a rehabilitation brace to standard rehabilitation by~     physiotherapy~   "
249684|NCT00284271|"~     This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2)~     toxicity, overall response and FFTF.~   "
249685|NCT00284258|"~     This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of~     IRIS, and feasibility of FOLFIRI. Phase III is aimed to verify inferiority of the progression~     free survival of IRIS in comparison with FOLFIRI.~   "
249695|NCT00284128|"~     The primary objective is to assess the antihypertensive efficacy of 4 different AVE 7688~     doses on the change from baseline in trough diastolic blood pressure at the end of week 12.~      The secondary objectives are:~        -  To assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from~          baseline in trough systolic blood pressure at the end of week 12~        -  To compare the percentages of responders after 12 week of treatment~        -  To evaluate the long term safety and tolerability of AVE 7688 with particular attention~          to angioedema~   "
249686|NCT00284245|"~     In earlier work, the Sponsor developed a computer image processing system for analysis of~     pain diagrams from patients with chronic pain. This system was then tested in a study in over~     500 chronic pain patients seen by both primary care practitioners and pain specialists. The~     hypothesis was that pain location would correlate with the pain type and the underlying cause~     of the pain. In the study, the computer analysis demonstrated clear correlations between pain~     diagram data and diagnosis/pain type. The present study extends these observations in a~     web-based setting, with a focus on the value of computer analysis of pain diagrams as~     diagnostic predictors.~   "
249687|NCT00284232|"~     A randomized controlled trial in patients with type 1 diabetes, assessing the metabolic~     effects of accurate blood sugar results and education. A systematic approach in~     self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients.~     Education in SMBG combined with a high analytical quality instrument for SMBG, introduced in~     a systematic and thorough way will improve HbA1c by 0,5% and keep it over a period of 9~     months.~   "
249688|NCT00284219|"~     Cigarette smoking is a major public health problem causing significant morbidity and~     mortality. Yet, smoking cessation therapies are often ineffective at helping smokers break~     their addiction.~      The mesolimbic dopaminergic reward system plays a crucial role in mediating the reinforcing~     effects of nicotine. Recently, acute high frequency repetitive transcranial magnetic~     stimulation (rTMS) of frontal brain regions has been shown to efficiently modulate the~     mesolimbic dopamine systems in both animals and humans. For this reason, we investigated~     whether 10 high-frequency (10Hz) rTMS treatments over the left dorsolateral prefrontal cortex~     can help people to withdraw smoking in comparison to placebo rTMS.~      Smokers seeking to quit are recruited through newspaper advertisements. Participants were~     randomized to 10 days of either real or placebo high frequency rTMS.~   "
249689|NCT00284206|"~     Objective of the Project.~      -Methamphetamine (MA) use is growing to epidemic proportions and existing treatments for MA~     dependence demonstrate sub-optimal efficacy. Research implicates heavy use of MA as at least~     a contributing agent to a variety of neuropsychiatric impairments including psychosis, mood~     disturbance, anxiety, cognitive deficits, and motor dysfunction. Initial study by this~     investigator suggests that agents like risperidone may also be beneficial to MA dependent~     individuals by decreasing MA use and improving cognitive function in early abstinence.~     Long-acting injectable risperidone may prove more efficacious given its receptor binding~     characteristics and potential to increase medication adherence. The study objective is to~     determine the safety and efficacy of treating MA dependence and the associated cognitive and~     psychiatric symptomatology with long-acting injectable risperidone.~   "
249690|NCT00284193|"~     Patients with severe hemophilia and inhibitors can be treated effectively by Activated~     Prothrombin Complex Concentrates (APCC, eg. FEIBA) or High dose recombinant factor VIIa~     (rFVIIa). Rarely, such patients develop refractoriness to these products for whom therapy~     with sequential FEIBA and rFVIIa has been recently suggested.~      The impetus for the present report was a hemophilia A patient with high titer inhibitor~     (1300BU) who had life threatening hematuria that was resistant to repeated doses of 400µg/kg~     rFVIIa up to a cumulative dose of 1200 µg/kg given over 6-9 hours.~      Thrombin generation (TG) tested in vitro was consistent with resistance to high~     concentrations of rFVIIa but yielded good response to combinations of low doses of~     rFVIIa+FEIBA. In a desperate attempt to control the bleeding, concomitant therapy of 25 U/kg~     FEIBA and 40µg/kg rFVIIa was infused and resulted in arrest of bleeding within minutes. Over~     a span of about one year the patient has been successfully treated by this combination for~     more than 200 bleeding episodes in muscles and joints.~   "
249691|NCT00284180|"~     This research study involves the anti-cancer medication trastuzumab and the investigational~     drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in~     combination or vinflunine alone is effective in the treatment of metastatic breast cancer~   "
249692|NCT00284167|"~     The primary objective of this study is to assess the benefit of using online, tailored~     behavioral weight management materials (Balance), in combination with nutritional materials~     (Balance and Nourish), in conjunction with a goal setting tool (Balance and Achieve), or a~     combination of all three (Balance, Nourish and Achieve). This objective will be evaluated by~     measuring weight loss rates as reported by study participants at 3, 12, and 18 months~     post-enrollment. The hypothesis is that adding additional materials will increase the effect~     of the intervention over just using Balance alone.~   "
249693|NCT00284154|"~     This clinical trial involves the administration of the chemotherapeutic medication~     vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of~     extensive small cell lung cancer. The purpose of this research trial is to study the~     effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer,~     evaluate the toxicity, and evaluate how long the response to this drug lasts.~   "
249694|NCT00284141|"~     This study evaluated the efficacy and safety of aflibercept in the treatment of participants~     with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA).~      Primary objective:~        -  To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept,~          aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in~          participants with platinum- and erlotinib-resistant, locally advanced or metastatic~          NSCLA.~      Secondary objective:~        -  To assess duration of response (DR), progression-free survival (PFS), and overall~          survival (OS) in this participant population~        -  To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap,~          ZALTRAP®).~      This study employed an Independent Review Committee (IRC) for radiological tumor assessments.~     For all tumor assessment-related efficacy variables, two analyses were performed: the primary~     analysis was based on Independent Review Committee (IRC) reviewed data and the secondary~     analysis was based on Investigator evaluation.~      In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response~     Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST~     criteria only consider the longest diameter of the tumors for calculations pertaining to~     changes in tumor size, mRECIST assessments also account for the differences in the cavities~     of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and~     mRECIST are reported.~   "
249696|NCT00284115|"~     Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive~     approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer~     enabling nonambulatory patients to have the repetitive practice of a gait-like movement.~   "
249702|NCT00284037|"~     Individuals with obstructive sleep apnea syndrome (OSAS) are at high risk for cardiovascular~     morbidity and mortality. The effect of long-term nocturnal therapy with continuous positive~     airway pressure (CPAP) on daytime baroreflex sensitivity (BRS), a predictor of cardiac death,~     was investigated in OSAS patients.~   "
249703|NCT00284024|"~     This study is testing if a medication called domperidone will help women produce more milk so~     that they can keep breastfeeding and not use formula. The study is also testing what dose of~     domperidone works best to increase breast milk production.~   "
249704|NCT00284011|"~     The purpose of this study is to determine if the oral intake of the dietary supplement SAMe~     increases blood homocysteine levels in healthy human subjects.~   "
249705|NCT00283998|"~     The purpose of this study is to compare the safety and effectiveness of surgical versus~     conservative management of type II odontoid fractures among patients >/= 65 years of age. Of~     secondary interest is to determine if there are differences in outcomes between anterior~     screw fixation and posterior fusion of these fractures.~   "
249706|NCT00283985|"~     Nasal/nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin's lymphoma (NHL)~     more frequent in Asia than in western countries. When localised, radiotherapy seems to be the~     best treatment. When radiotherapy cannot be used because of dissemination or relapse,~     chemotherapy protocols used for other types of NHL give poor results and survival is poor.~     Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually~     used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours~     by l-asparaginase was shown on tumour cell lines and samples.~      The investigators propose a phase II protocol for patients with refractory or relapsing~     nasal/nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate~     and dexamethasone. Biological studies will be conducted trying to find factors which could~     predict responses to this chemotherapy.~      Since january 2009, the study concerns all patients with nasal/nasal type NK-T-cell lymphoma~     who have not received asparaginase before.~   "
249707|NCT00283972|"~     To prospectively observe the association of the LAP-BAND procedure on quality of life,~     anthropometric, metabolic and biochemical parameters in morbidly obese patients when~     performed by experienced US surgeons. The study will also include a complete economic~     analysis of the LAP-BAND procedure and follow-up costs Hypothesis: Measurements defining~     quality of life and the severity of obesity and obesity related comorbidities improve~     significantly over baseline with the LAP-BAND System treatment at 6 and 12 months post~     surgery when performed by an experienced surgeon.~   "
249708|NCT00283959|"~     The purpose of this study is to collect information on the safety of AT1001 (migalastat~     hydrochloride) and how AT1001 works in patients with Fabry disease.~   "
249709|NCT00283946|"~     The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR~     Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using~     zolpidem (Myslee) as a comparative drug~   "
249710|NCT00283933|"~     The purpose of this study is to collect information on the safety of AT1001 (migalastat~     hydrochloride) and how AT1001 works in patients with Fabry disease.~   "
249711|NCT00283920|"~     This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI)~     to measure peripheral benzodiazepine receptors (PBRs) in the brain. PBRs were initially found~     in peripheral organs such as kidneys, endocrine glands and lungs, but later studies~     identified PBRs in the CNS. PBRs can be a marker to detect nervous system inflammation.~     Development of a test to image PBRs may improve the management of brain disorders such as~     multiple sclerosis, Alzheimer's disease, Parkinson's disease, and others in which~     inflammation is involved in progression of the disease.~      Healthy volunteers from 18 to 40 years old may be eligible for this study. Candidates are~     screened with tests that may include some or all of the following: diagnostic interview;~     ratings of mood, anxiety, functioning, and other parameters; neuropsychological testing;~     physical examination; electrocardiogram; blood and urine tests; and personal, social and~     family histories.~      Participants undergo the following procedures:~        -  Evaluation: Subjects provide a medical history, including detailed questions about their~          psychological health, and have a physical examination and blood and urine tests.~        -  PET scanning: PET uses small amounts of a radioactive chemical called a tracer that~          labels active areas of the brain. The tracer used in this study is [11C]PBR28. For the~          procedure, the subject lies on the scanner bed. A special mask is fitted to the head and~          attached to the bed to help keep the head still during the scan so the images will be~          clear. A brief scan is done just before the radioactive tracer is injected to provide~          measures of the brain that will help to precisely calculate information from subsequent~          scans. After the tracer is injected through a catheter (plastic tube) placed in the arm,~          pictures are taken for 2 to 3 hours, during which the subject lies still on the scanner~          bed. Subjects return to the clinic the following day for more blood and urine sample~          collections.~        -  MRI: The MRI scan is done within 1 year of the PET scan (either before or after the~          PET). MRI uses magnetic fields and radio waves to produce images of the brain. The~          patient lies on a table that is moved into the scanner (a narrow cylinder), wearing~          earplugs to muffle loud knocking and thumping sounds that occur during the scanning~          process. He or she can communicate with the staff at all times during the procedure.~   "
249712|NCT00283907|"~     This study of healthy normal volunteers will examine the brain networks involved in people's~     sense that they control their own movements (sense of agency). Although almost everyone has a~     sense of agency, some patients (for example, patients with schizophrenia, alien limb~     phenomena, and others) have movements they think are not under their control. This study will~     use electroencephalography (EEG) to determine how the normal brain produces the sense of~     agency. This information will provide a first step in understanding patients with an impaired~     sense of agency.~      Healthy, right-handed men and women 18 years of age and older may be eligible for this study.~     Candidates are screened with a medical history and neurological examination.~      Participants are fitted with a cyberglove device (a lightweight glove with flexible sensors~     that measure the position and movement of the fingers and wrist) on their right hand. The~     glove is used to transform the subject's hand and finger motions into real-time digital~     joint-angle information. Subjects slowly open and close their hand while watching an~     artificial hand projected on a monitor. They continue practicing the exercise until they are~     comfortable with the cyberglove and have the sense that the artificial hand is a mirror~     representation of their own hand, accurately reflecting their hand's movements.~      After practicing with the cyberglove, subjects have a functional EEG. For this test,~     electrodes are placed on the scalp, and brain waves are recorded while the subject opens and~     closes his or her hand or just watches the computer monitor. The EEG recording takes about 60~     minutes.~   "
249727|NCT00283712|"~     Pemphigus vulgaris (PV) is a rare skin disorder that causes blistering of the skin and mucous~     membranes. Infliximab is a man-made antibody used to treat certain types of immune system~     disorders, including rheumatoid arthritis and Crohn's disease. This study will determine if~     infliximab given in combination with prednisone is a safe and effective treatment for adults~     with PV.~   "
249713|NCT00283894|"~     This study will measure energy expenditure (the rate at which the body burns calories),~     physical activity and caloric intake in people with narcolepsy to learn more about how the~     risk of becoming overweight or diabetic may be affected.~      Healthy control subjects and people with narcolepsy between 18 and 55 years of age may be~     eligible for this study. Participants are withdrawn from their narcolepsy medication and~     undergo the following tests and procedures over 5 weeks before resuming medications.~        -  Blood draw for genetic studies.~        -  Collection of a cerebrospinal fluid sample.~        -  Diet to keep subjects' weight constant.~        -  Activity watch, using a device worn on the wrist to measure amount of movement, and an~          activity monitor worn at the waist to measure physical activity and caloric expenditure.~        -  Questionnaires about sleepiness, symptoms, food intake, exercise and mood.~        -  24-hour urine collection and 24-hour blood draw to measure hormones.~        -  Glucose tolerance test. The subject drinks a sugar solution and blood samples are~          collected through a catheter before drinking the solution and 30 minutes, 1, 2 and 3~          hours after drinking it.~        -  Startle reflex test. Subjects hear a loud noise through headphones and are asked to look~          at pictures.~        -  Sleep study to evaluate sleep-related breathing disturbances and record information~          about sleep stages.~        -  Indirect calorimetry test to measure how fast the body uses calories. A plastic canopy~          is placed over the face for several minutes to capture the air exhaled to analyze oxygen~          use. To measure the energy associated with meals, the same measurements are taken after~          the subject eats lunch.~        -  CT scan of the abdomen to see how much fat is deposited in the abdomen, and DEXA scan of~          the whole body to see the percentage of fat and muscle.~        -  Plethysmography. Participants sit in an enclosed chamber while the mass and volume of~          the body are measured by changes in air pressure.~        -  Neuropsychological testing to assess thought processes.~        -  Continuous 24-hour heart rate measurement.~        -  Metabolic chamber. Subjects spend 24 hours in a small room to measure the amount of~          oxygen inhaled and carbon dioxide exhaled.~        -  Walking/running test to assess level of physical conditioning.~        -  Dexamethasone CRH (corticotropin-releasing hormone) suppression test and CRH stimulation~          test. Subjects receive eight doses of 0.5 mg dexamethasone every 6 hours for a day and a~          half. After the last dose, two blood samples are drawn, then a dose of CRH is injected,~          and then six more blood samples are drawn over the next 3 hours.~        -  TRH (thyrotropin-releasing hormone) stimulation test. Subjects are given TRH through a~          vein, and several blood samples are then drawn over the next 3 hours.~        -  Doubly labeled water test. Subjects drink a dose of heavy water. Urine samples are~          collected at 2, 3 and 5 hours after drinking and again for two 4-hour collections a week~          later.~   "
249714|NCT00283881|"~     This study will determine if stimulation of the stroke-injured side of the brain combined~     with stimulation to the paralyzed hand can temporarily improve the sense of touch in stroke~     patients.~      Healthy normal volunteers and people who have had a single stroke within 3 months of entering~     the study that affected one side of the brain may be eligible for this study. All~     participants must be between 18 and 90 years old and must be right-handed. Candidates are~     screened with a medical history, neurological examination and magnetic resonance imaging~     (MRI) of the brain if one has not been done within 1 year of entering the study.~      Participants undergo the following tests and procedures during four 2-day sessions over about~     6 weeks:~        -  Peripheral high-frequency stimulation: Small loudspeakers are taped to the fingertips~          and simple tactile pulses are passed through the skin. Stimulation may be sham or real.~        -  Transcranial direct current stimulation: Two small rubber electrodes are taped to the~          head - one above the eye and the other on the back of the head. A current is passed~          between the two electrodes. Stimulation may be sham or real.~        -  MRI: The subject lies in the scanner, a metal cylinder surrounded by a magnetic field,~          for about 40 minutes, lying still for up to 40 minutes at a time. An electrical~          stimulation is applied to the fingers of the right and left hand in separate sessions.~          Earplugs are worn to muffle the loud noises during the scanning. Functional MRI measures~          blood flow changes in the brain during the performance of specific tasks.~        -  Behavioral measurements:~             -  Grating orientation task: The subject responds as quickly as possible to a touch~               stimulus to the finger by saying whether the direction of the stimulus is vertical~               or horizontal.~             -  Haptic object recognition task: The subject is given five categories of unfamiliar~               objects in the shape of cubes. During the task, identical objects are hidden in a~               sack. With eyes closed, the subject is asked to identify and find the objects from~               the sack as quickly as possible.~             -  Pegboard test: The subject is asked to place several pegs into a corresponding hole~               of a pegboard as soon as possible.~             -  Tapping task: The subject is asked to tap a metal stick on a metal plate as quickly~               as possible for 1 minute.~        -  Paired-pulse transcranial magnetic stimulation: This test measures changes in brain~          activity. A wire coil is held on the scalp and a brief electrical current is passed~          through the coil, creating a magnetic pulse that stimulates the brain. The subject hears~          a click and may fee a pulling sensation on the skin under the coil, and there may be a~          twitch in the muscles of the face, arm or leg. Subjects may be asked to tense certain~          muscles slightly or perform other simple actions.~        -  Paired-pulse somatosensory evoked potential mapping: This test measures brain activity~          in another brain area. The subject is seated in a chair with eyes closed. One electrode~          is placed above the eye and two others are placed on the back of the head. A short~          electrical stimulus is applied to a nerve in the wrist and brain activity is recorded~          while the stimulus is applied.~        -  Surface electromyography: This test measures the electrical activity of muscles.~          Electrodes are filed with a conductive gel and taped to the skin.~        -  Visual analog and mood scale: Subjects complete questionnaires about their attention,~          fatigue and mood.~   "
249715|NCT00283868|"~     The purpose of this trial is to determine if an experimental remote video camera system is an~     effective way for a stroke specialist to evaluate stroke patients from a distant site.~   "
249716|NCT00283855|"~     The objective of this study is to determine the effects of an arthritis self-management~     program and an online support community delivered via an encrypted, secure web site on~     psychological well-being, pain, quality of life, global health status, and social supporting~     in adults with RA.~   "
249717|NCT00283842|"~     The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment~     of neuropathic pain associated with diabetic peripheral neuropathy.~   "
249718|NCT00283829|"~     The purpose of this study is to test if interleukin-2, a drug that stimulates the immune~     system, can be used after chemotherapy to slow the progression of your disease. We also want~     to test what the best dose of interleukin-2 is that can be used safely at home.~      Interleukin-2, abbreviated as IL2, is a naturally produced growth hormone for the immune~     cells in our body. It stimulates the growth of the immune cells and enhances their ability to~     fight infections and cancers. In people with cancer, the immune cells are typically~     suppressed and became even more so after irradiation and chemotherapy treatment. By giving~     you more IL2 we hope to enhance the immune system so that it can fight the cancer better,~     control cancer growth and shrink the cancer.~   "
249719|NCT00283816|"~     Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may~     increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic~     state. This study is to determine whether metformin added to oral contraceptive therapy in~     adolescent women with PCOS improves metabolic state.The study will also test a lifestyle~     improvement program to reduce weight.~   "
249720|NCT00283803|"~     The purpose of this research study is to determine if an investigational drug called~     Exisulind will extend the off-treatment period of patients receiving Intermittent Androgen~     Suppression (ADT).~      There is evidence suggesting that alternating between periods of treatment and no treatment~     with androgen suppressants may delay the time to develop androgen-insensitive progression and~     improve overall quality of life. During intermittent androgen suppression (IAS) treatments,~     men receive a luteinizing hormone-releasing hormone (LHRH) agonist and antiandrogen for a~     fixed period of time (approximately 9 months) and then enter an off-treatment period, whose~     length will vary, depending on the rate of rise in the patient's Prostate-Specific Antigen~     (PSA). Once the PSA reaches an established threshold (1 ng/mL in men who have had a~     prostatectomy or 4 ng/ml in men with an intact prostate), androgen suppression will be~     re-initiated for another 9 months. These cycles of on-treatment/off-treatment will be~     repeated until patient no longer responds to the androgen suppression and it is clear that~     their cancer is progressing. It has been observed that off-treatment periods tend to become~     shorter with each successive cycle of androgen suppression, presumably due to the emergence~     of androgen-independent clones. This study proposes to look at exisulind, a pro-apoptotic~     drug, which may extend the off-treatment period in patients receiving IAS.~   "
249721|NCT00283790|"~     Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem~     Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young~     Volunteers, Using Flurazepam 30 mg as an External Comparator~   "
249722|NCT00283777|"~     The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis~     of the study was to evaluate the effect of supplementing the diet of individuals with Type 2~     diabetes with chromium picolinate and assessing the effect on blood glucose levels and~     insulin sensitivity~   "
249723|NCT00283764|"~     Compare the antihypertensive efficacy of two methods for instilling Xalatan eyedrops~   "
249724|NCT00283751|"~     This trial is conducted in Europe and the United States of America (USA). The aim of the~     trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is~     at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug~     treatment in reducing HbA1c in patients with Type 2 Diabetes.~   "
249725|NCT00283738|"~     The objective of the study is to investigate the safety and effectiveness of PFO closure with~     the BioSTAR Septal Repair Implant System in a population of patients that have refractory~     migraine (with aura) and who have failed medications.~   "
249726|NCT00283725|"~     The purpose of this observational study is to examine patterns of treatment care for patients~     with Alzheimer's disease (AD) in a real-world arena and to examine the association with~     different outcomes for patients and informal caregivers.~   "
249728|NCT00283699|"~     The purpose of this study is to determine if treatment with albendazole improves the clinical~     outcome of neurocysticercosis infection and/or leads to the disappearance of cysts sooner~     when compared with symptomatic treatment.~   "
249729|NCT00283686|"~     The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the~     progression of cystic disease and on the decline in renal function in autosomal dominant~     kidney disease (ADPKD) will be assessed in two multicenter randomized clinical trials~     targeting different levels of kidney function: 1) early disease defined by GFR >60~     mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73~     m2 (Study B; NCT01885559). Participants will be recruited and enrolled, either to Study A or~     B, over the first three years. Participants enrolled in Study A will be followed for at least~     5 years, while those enrolled in Study B will be followed for five-to-eight years, with the~     average length of follow-up being six and a half years. The two concurrent randomized~     clinical trials differ by eligibility criteria, interventions and outcomes to be studied.~   "
249730|NCT00283673|"~     This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised~     exercise versus no exercise. Several end points were evaluated after 16 weeks including~     insulin sensitivity and muscle physiology.~   "
249731|NCT00283660|"~     This study will determine whether supplements of the mineral zinc will improve mental health~     and school performance among schoolchildren in Guatemala.~   "
249732|NCT00283647|"~     Exposure to lead during pregnancy, infancy, and childhood increases the individual likelihood~     of impaired school performance, increased impulsiveness, aggression, and delinquent behavior.~     Disorders that result from exposure to environmental neurotoxicants are a complex web of~     interactions between genetic, neurochemical, biochemical, environmental and social factors~     that influence children during critical periods of development. To date, research in the area~     of human developmental neurotoxicology focuses primarily on global measures of sensory-motor~     development and cognition. However, studies elucidating the biological basis for~     developmental and behavioral disorders due to environmental toxicant exposure are lacking.~     Although gross brain structure appears normal, underlying problems exist at a neural level.~     Our proposal seeks to relate childhood environmental lead exposure at various levels and~     stages of development with detriments in brain structure and neurochemical functioning~     assessed with magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).~     Cortical and subcortical brain volumes will be determined with high resolution MRI. Neuronal~     and glial cell markers will be measured using proton MRS. These structural and chemical~     measures will also be correlated with behavioral measures from the young adult participants~     of the Cincinnati Lead Study (CLS). These participants represent a unique and ideal cohort of~     approximately 240 subjects with detailed histories of exposure and behavioral outcomes in~     lead exposed children monitored for approximately 20 years. A pilot study examining language,~     working memory and attention in combination with functional magnetic resonance imaging (fMRI)~     will also be performed to better understand the functional and behavioral deficits.~   "
249733|NCT00283634|"~     Tarceva, an orally available small molecule, has demonstrated potent activity in tumor models~     and humans. This randomized, open-label phase 2 study of Tarceva alone and of Tarceva plus~     VELCADE is designed primarily to determine the objective tumor response rates to these~     treatments in patients with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC) that is~     refractory to or has relapsed after front-line chemotherapy.~   "
249734|NCT00283621|"~     To determine the percentage of patients and number of cycles in which a packed red blood cell~     transfusion was administered due to anemia and in which antibiotics were administered due to~     neutropenic fever.~   "
249735|NCT00283608|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving~     anastrozole may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors learn more about how anastrozole works~     in the body.~      PURPOSE: This research study is looking at the pharmacogenetics of anastrozole in~     postmenopausal women with estrogen receptor-positive (ER+) and/or progesterone~     receptor-positive (PR+) stage I, stage II, or stage III breast cancer.~   "
249736|NCT00283595|"~     Decreased bone strength is a serious medical problem present in many women with Anorexia~     Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones~     than women with normal bone strength.~      We are investigating whether a hormone that is naturally produced by the human body, called~     growth hormone, can help strengthen the bones of women with this type of disordered eating.~   "
249737|NCT00283582|"~     Intensive chemotherapy is often associated with low platelet counts often requiring platelet~     transfusions to maintain platelet counts. In previous clinical studies administration of~     rhTPO has been demonstrated to increase platelet counts.~   "
249738|NCT00283569|"~     To establish a clinic based case control study for examination of potential risk factors for~     primary adult brain tumors.~   "
249739|NCT00283556|"~     The purpose of this study is to compare the response to treatment and side effects associated~     with high dose irinotecan in patients with recurrent brain tumors.~   "
249740|NCT00283543|"~     To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with~     Temozolomide~   "
249741|NCT00283530|"~     The purpose of this study is to identify the genetic makeup of cancers, the cancer response,~     and the correlation of the cancer response to standardized regimens of cancer treatment.~   "
249742|NCT00283517|"~     The purpose of the study is to assess demographic, treatment, and outcome data in~     schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid~     formulations of first generation (conventional) or second generation (atypical) antipsychotic~     medications.~   "
249743|NCT00283504|"~     The researcher proposes to assess levels of sputum inflammatory markers (eosinophils,~     eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in~     a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma~     symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).~      Associations will be assessed between the types of sputum inflammatory markers and the~     patient's atopic status and level of asthma control as indicated by the following measures:~        1. pulmonary function test (PFT)~        2. asthma symptoms based on the Asthma Control Test (ACT)~   "
249744|NCT00283491|"~     The purpose of this study is to determine the effect of a lactic acid fermented oat gruel on~     iron absorption in the upper and lower part of the intestine, respectively.~   "
249745|NCT00283478|"~     To determine if Iscar Quercus improves immune function and quality of life among patients~     with stage IV non-small cell lung cancer.~   "
249746|NCT00283465|"~     The purpose of this study is to compare the effectiveness of early treatment of anemia with~     epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard~     anemia care on the need for blood transfusions, tumor response, anemia and quality of life in~     patients with cancer receiving platinum-containing chemotherapy.~   "
249747|NCT00283452|"~     The purpose of this study is to determine whether a new phone and mail based coaching/support~     program that has been developed is more effective in helping people stay physically active~     than existing programs that are currently available to all HealthPartners members. We~     hypothesize that the intervention program will lead to a greater likelihood of physical~     activity maintenance among moderately active older adults than a usual care condition.~   "
249748|NCT00283439|"~     The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG~     531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with~     lymphoma receiving multi-cycle chemotherapy.~   "
249749|NCT00283426|"~     The purpose of this study is to determine whether soluble beta-1,3/1,6-glucan is an effective~     and safe treatment of thermal burns and non-injured skin where skin grafts are harvested.~      Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities improve~     wound healing of thermal burns and non-injured skin where skin grafts are harvested.~   "
249750|NCT00283413|"~     The objective of the Symbiot III Clinical Trial was to evaluate the safety and effectiveness~     of the Symbiot Covered Stent System in the treatment of symptomatic ischemic saphenous vein~     bypass graft disease.~   "
249751|NCT00283400|"~     The purpose of this study is to evaluate the tolerability and safety of 25 percent human~     albumin therapy in patients with subarachnoid hemorrhage.~   "
249752|NCT00283387|"~     The aim of this study is to assess the efficacy and safety of betaine in reducing urine~     oxalate excretion of Type 1 Primary Hyperoxaluria (PHI) patients.~      Hypothesis:~      Betaine will effectively reduce urine oxalate excretion in Primary Hyperoxaluria Type I~     patients.~   "
249753|NCT00283374|"~     Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its~     definition is still evolving. Patients with this syndrome are at increased risk for~     cardiovascular disease, and at increased risk of mortality from cardiovascular disease.~      Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal~     obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous~     (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and~     thought to play a major role in the metabolic disturbances associated with obesity and~     metabolic syndrome.~      Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and~     is associated with obesity, insulin resistance and metabolic syndrome.~      Bariatric surgery has yielded dramatic results including longitudinal loss of excess body~     weight and either complete reversal or significant improvement of several features of~     metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.~   "
249754|NCT00283361|"~     The main purpose of this study is to see if the experimental drug ZP120, when given with the~     approved drug furosemide to patients with acute or sub-acute heart failure, can reduce the~     amount of fluid in the patients' lungs and make breathing easier.~   "
249755|NCT00283348|"~     The purpose of this study is to help researchers find out more about a condition called~     Chronic Allograft Nephropathy (CAN). CAN is a complication that sometimes occurs after~     kidney transplantation and affects the function of the transplanted kidney. It is hoped that~     by studying blood, urine, and tissue samples of kidney transplant patients, new ways of~     diagnosing and treating CAN may be found.~   "
249756|NCT00283335|"~     This was a double-blind randomized trial comparing 1200 mg per day of gemfibrozil with~     placebo in 2531 men with coronary heart disease, an HDL-C of 40mg/dl or less, an LDL-C of 140~     mg/dl or less, and triglycerides of 300mg/dl or less. The primary outcome was nonfatal~     myocardial infarction(MI) or death from coronary causes. The median follow-up was 5.1 years.~     There was a risk reduction of 22% in the primary outcome (p=.0006) and 24% risk reduction in~     the combined endpoint of stroke, MI, and CHD death. The rate of events was reduced by raising~     HDL-C and lowering triglycerides without lowering LDL-C (N Engl J Med 1999;341:410-418).~   "
249757|NCT00283322|"~     Intensive care unit patients have multiple risk factors for venous thromboembolism. Venous~     thromboembolism leads to significant morbidity and can be fatal. Unfractionated heparin and~     low molecular weight heparin are commonly used to prevent venous thromboembolism. Heparin~     induced thrombocytopenia, an untoward consequence of exposure to heparin, is an immune~     disorder that may develop in patients treated with heparin products. Determining the~     prevalence of heparin induced thrombocytopenia and its relationship to preventive and~     therapeutic heparin and low molecular weight heparin will help clinicians more appropriately~     choose methods of venous thromboembolism prophylaxis and treatment in the critically ill, ICU~     population.~      The objective of this study is to determine the prevalence of heparin-induced antibodies on~     admission to the ICU and the development of new heparin-antibodies during the first week of~     hospitalization.~   "
249758|NCT00283309|"~     The primary purpose is to determine if patients scheduled to receive prescription~     corticosteroid therapy for inflammatory illnesses who are given either memantine or riluzole~     pretreatment will show lesser declarative memory impairment than those receiving placebo.~      The exploratory purpose is to determine if patients scheduled to receive prescription~     corticosteroid therapy for inflammatory illnesses who are given memantine or riluzole~     pretreatment will show a smaller increase in manic/hypomanic symptom severity than those~     receiving placebo.~   "
249759|NCT00283296|"~     The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding,~     ultralight manual wheelchair that incorporates small swing-down wheels for navigation in~     confined areas. This enables access to narrow environments such as those encountered in~     offices, restrooms, and transportation settings. When using the small access wheels, the~     wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead~     compartment. It is anticipated that the Endeavor will maximize mobility; increase access to~     confined areas; and ease the demands of travel for people with disabilities.~   "
249760|NCT00283283|"~     This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu~     season.~   "
249774|NCT00283088|"~     The purpose of this trial is to evaluate if it is safe to use tissue plasminogen activator~     (tPA) within 6 hours of stroke onset when combined with hypothermia.~   "
249761|NCT00283270|"~     The aim of the study is to test whether screening followed by brief problem-solving~     counselling in primary care could improve the quality of life of elderly patients with~     undiagnosed psychological problems. We hypothesize that undiagnosed psychological problems~     detectable by screening are common in the elderly and brief counselling could improve the~     quality of life of these patients.~   "
249762|NCT00283257|"~     This is a multi-site randomized control trial taking place at six cancer centers. UC Davis is~     the lead site. Additional performance sites include the City of Hope Medical Center, Fred~     Hutchinson Cancer Center at the Univ. of Washington, USC Norris Cancer Center, UCSD Cancer~     Center, and Johns Hopkins Cancer Center. Clinical trial patients and their caregivers who are~     randomized to the intervention arm of the study are scheduled for three educational sessions.~     The sessions focus on teaching problem solving skills based on the COPE problem solving~     model.~   "
249763|NCT00283244|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It is not yet known whether gemcitabine and erlotinib are more effective when given~     alone or together in treating non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how~     well they work when given alone or together as first-line therapy in treating older patients~     with stage IIIB or stage IV non-small cell lung cancer.~   "
249764|NCT00283231|"~     This is an uncontrolled pilot clinical trial to determine the feasibility of recruitment and~     effectiveness of a device called RESPeRATE that paces respiration to treat menopausal hot~     flashes in 12 peri- or postmenopausal women. Participants will practice paced respiration for~     15 minutes everyday for six weeks and attend assessment visits at weeks 3 and 6.~   "
249765|NCT00283218|"~     The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin~     analogues will improve post prandial glycaemic control in patients with type 1 diabetes.~      OBJECTIVE:~      The objective is to describe pharmacodynamic (PD) and pharmacokinetic (PK) profiles of~     Insulin Aspart (IAsp), Biphasic Insulin Aspart (BIAsp) 30, 50 and 70 for a period of 12 hours~     following a standard test meal on four days respectively in subjects with type 1 diabetes.~   "
249766|NCT00283205|"~     The Yoga for Treatment of Hot Flashes and Menopausal Symptoms is an uncontrolled pilot~     clinical trial to determine the feasibility of recruitment and of evaluating yoga for the~     relief of menopausal hot flashes in 12 peri- or postmenopausal women. Participants will~     attend an Introductory Yoga Workshop, 8 yoga training sessions in 8 weeks, be assessed~     clinically before, during, and after training and contacted by telephone 3 months later.~   "
249767|NCT00283192|"~     The primary outcome of FAST (a randomized double-blinded, placebo controlled, trial of the~     effect of sertraline vs. placebo in reducing the incidence and severity of hot flushes in~     healthy women) is to determine if 6 weeks of treatment with sertraline (50mg daily for 2~     weeks, followed by 100mg per day for 4 weeks, if tolerated) results in a greater reduction in~     hot flush score (frequency * severity) compared to placebo among women with moderate to~     severe hot flashes. The secondary aim is to determine the effect of treatment with sertraline~     on quality of life, sleep, sexual function, and mood.~   "
249768|NCT00283179|"~     To evaluate the efficacy, safety and tolerability of aripiprazole in the treatment of acutely~     relapsed patients with diagnoses of schizophrenia or schizoaffective disorder with~     risperidone as an active control.~   "
249769|NCT00283166|"~     An estimate of 90% of patients with cancer experience at least moderate pain at some point in~     their illness, and 42% of patients do not receive adequate palliation. The main objective of~     this research is to reduce barriers to pain control by creating more effective partnerships~     between patients and their health care providers. The aims of the study are: 1) to compare~     the effects on pain, cancer-related symptoms, and health-related quality of life of a~     standard cancer pain leaflet versus face-to-face, tailored education and coaching; 2) to~     estimate the effect of tailored education and coaching on patients' self confidence for~     managing their pain and participating actively in care; and 3) to examine the mechanisms~     underlying the beneficial effects of the intervention. The proposed model will enhance~     research on pain management in that it is a pilot-tested intervention that is applicable in~     the outpatient setting, based on Social Cognitive Theory, and focused on patient activation~     and education.~   "
249770|NCT00283153|"~     The purpose of this research is to evaluate the effectiveness of three training programs~     designed to teach persons with acquired brain injury (ABI) to recognize emotions. It is~     hypothesized that the training programs will enhance several aspects of emotion recognition~     in persons with ABI. Furthermore, it is expected that these effects will be maintained over~     time, and will positively influence participants' social behavior and integration.~   "
249771|NCT00283127|"~     Urogenital Chlamydia trachomatis infection is the most common bacterial sexually transmitted~     infection in Norway. Urogential C.trachomatis infection can easily be treated with~     antibiotics. However, left untreated it is a major cause of pelvic inflammatory disease (PID)~     that can lead to complications such as infertility, ectopic pregnancy and chronic pelvic pain~     in women. Most infections are asymptomatic and many do not seek the doctor for testing.~     Therefore cases remain undetected and untreated.We want to determine the efficacy and~     feasibility of screening for urogenital C. trachomatis infection with home sampling~     (intervention) compared to the current strategy of conventional sampling at the doctor's~     office (control) in identifying men and women aged 18-25 years with urogenital C.trachomatis~     infection (Part A). We also want to identify factors influencing the acceptability of home~     sampling for C.trachomatis infections (Part B)and determine factors associated with~     C.trachomatis infections (Part C).~   "
249772|NCT00283114|"~     Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the~     toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with~     myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative~     diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose~     from phase 1a.~   "
249773|NCT00283101|"~     This is an open-label, dose-escalation study to determine the tolerability, safety profile,~     and antitumor activity of SGN-40 in patients with CLL. All patients will receive dose~     escalation during the first two weeks regardless of cohort designation.~   "
249775|NCT00283075|"~     This is a phase 1 trial to evaluate the safety and toxicity of mouse kidney cancer~     cell-containing agarose-agarose macrobeads that are implanted in the abdominal cavity as a~     proposed biological treatment of patients with end-stage, treatment-resistant cancer. The~     macrobeads have been extensively tested in tumor models in mice and rats, as well as in~     forty-five veterinary patients (cats and dogs) with naturally occurring tumors of various~     types including breast cancer, prostate cancer, liver cancer, and lymphoma with clear tumor~     responses and no significant detectable toxicity.~   "
249776|NCT00283062|"~     This is a prospective, multicenter, open-label, randomized phase III study in participants at~     high risk of recurrent prostate cancer after radical prostatectomy. The study will~     investigate~        -  Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate~          (ELIGARD®) versus leuprolide acetate alone (ELIGARD®)~        -  Immediate treatment following prostatectomy versus deferred treatment at the time of~          relapse~      Using a 2x2 factorial design participants will therefore be randomized to~        -  Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and~          hormonal therapy)~        -  Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy)~        -  Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal~          therapy)~        -  Deferred treatment with leuprolide acetate alone (hormonal therapy)~      Primary Objective:~        -  The primary objective of the study is to compare progression-free survival using a 2x2~          factorial design~      Secondary Objectives:~        -  To compare the 5-year overall, cancer-specific and metastasis-free survival after~          systemic treatment between the groups~        -  To compare the safety and tolerability between Docetaxel in combination with leuprolide~          acetate and leuprolide acetate alone.~        -  To evaluate quality of life as measured by the FACT-P questionnaire.~      Originally, 1696 participants were planned in the study (with 424 participants randomized to~     each arm). However, only a total of 211 participants completed the randomization procedure as~     of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee,~     decided to stop the participant recruitment as of 26 September 2007. Participants who had~     already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter~     the randomization if they met eligibility criteria. The final revised number of planned~     participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants~     were actually randomized.~      The final sample size did not allow all the statistical analyses to be conducted on efficacy~     data. Therefore, the protocol was amended to reflect the change in the plans for statistical~     analysis. The study was underpowered to serve as the basis for drawing conclusions regarding~     efficacy and quality of life (QoL) endpoints.~   "
249777|NCT00283049|"~     The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to~     Week 12 between the 3 treatment arms.~   "
249778|NCT00283036|"~     Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan~     in ambulatory Hypertensive patients~   "
249779|NCT00283023|"~     Recent developments in the understanding of stem- and progenitor cell differentiation raises~     hopes that brain damage in chronic neurological diseases may become repaired by systemic or~     focal transplantation of such cells. Clinical trials of stem- or progenitor cell~     transplantation in multiple sclerosis are currently premature. The researchers developed a~     protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment~     of demyelinating disease.~   "
249780|NCT00283010|"~     The primary objective of this study is to evaluate the effects of a computer-based training~     program on the memory and cognitive abilities of mature individuals undergoing healthy aging.~   "
249781|NCT00282997|"~     To evaluate the safety of pregabalin in patients with fibromyalgia.~   "
249782|NCT00282984|"~     The primary purpose of this study is to determine whether or not varenicline will help people~     with cardiovascular disease quit smoking and to confirm it is safe in these patients.~   "
249783|NCT00282971|"~     To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes~     who are not well controlled on 2 or more oral anti-diabetic agents~   "
249784|NCT00282958|"~     To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain~     but also for subacute pain.~   "
249785|NCT00282945|"~     The purpose of this study is to determine whether markers of b-cell function can predict~     changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM)~     randomized to treatment with metformin or rosiglitazone.~   "
249786|NCT00282932|"~     An interventional active/placebo double blinded parallel randomized controlled study in which~     at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is~     measured along with associated safety and other secondary endpoints like bladder diary~     endpoints, quality of life and patient treatment satisfaction.~      Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and~     Urgency of at least 1 episode per day confirmed by bladder diary).~      Patients are not eligible to enroll in the study if they have/had significant hepatic or~     renal disease, history of radiation treatment.~   "
249787|NCT00282919|"~     The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.~   "
249788|NCT00282906|"~     This is an National Institute of Health (NIH) funded, investigator-initiated, single center~     prospective study to investigate the ability of the new dual-modality positron emission~     tomography and computed tomography (PET-CT) imaging systems in comparison to conventional~     imaging methods in assessing treatment response in men with metastatic prostate cancer. The~     investigators will enroll two groups of men with stage IV metastatic prostate cancer, each~     group will be comprised of 160 patients.~        -  Group I: men with newly diagnosed hormone-responsive measurable metastatic disease who~          will be treated with androgen-ablation therapy~        -  Group II: men with newly-developed hormone-refractory measurable metastatic disease who~          will be treated with chemotherapy and /or other therapies for hormone refractory disease~      To be eligible, men in either group must have rising serum prostate specific antigen (PSA)~     level - defined as at least 2 consecutive rises in PSA documented over a reference value (1st~     measure within 28 days prior to recruitment). The first rising PSA (2nd measure) should be~     taken at least 14 days after the reference value. A confirmatory PSA measure (3rd measure)~     obtained at least 14 days after the 2nd measure is required and must be greater than the 2nd~     measure. Additionally, patients must have a serum PSA concentration of at least 2 ng/mL in~     addition to increasing PSA to be eligible. Patients will be followed with the PET-CT at 4, 8,~     and 12 months after the initiation of androgen ablation therapy (Group I) or chemotherapy~     (Group II).~   "
249789|NCT00282893|"~     The purpose of this study is to determine if early transluminal ballooning of the major~     cerebral arteries prevents severe vasospasm and improves neurological outcome in patients~     with Fisher Grade III aneurysmal subarachnoid hemorrhage.~   "
249790|NCT00282867|"~     The purpose of this study is to assess the feasibility, safety and preliminary efficacy of~     the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.~   "
249791|NCT00282854|"~     The purpose of this study is to find the genes that cause Rolandic epilepsy and its related~     traits.~   "
249792|NCT00282841|"~     The purpose of this study is to find out more about the usefulness of ultrasound in~     combination with a contrast solution to look for blood vessel blockage or occlusion in the~     brains of stroke patients.~   "
249796|NCT00282789|"~     We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive~     airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would~     improve LV function.~   "
249797|NCT00282776|"~     This study will evaluate the effectiveness of a telephone-based depression screening and care~     management program in treating depression in postpartum women.~   "
249798|NCT00282763|"~     The purpose of this Study is to test the Safety and Effectiveness of MK0686 in relieving~     neuropathic (chronic) pain as experienced by patients with Postherpetic Neuralgia (Also Know~     as PHN or Post Shingles Pain).~      This is an early phase trial and some specific protocol information is proprietary and not~     publicly available at this time. (Full information is available to trial participants).~   "
249799|NCT00282750|"~     The purpose of this study is to test whether bar coded surgical sponges can significantly~     increase the safety of operations, specifically by (1) reducing discrepancies and miscounts,~     (2) reducing total staff time spent on sponge counting, and (3) reducing disruptions to the~     operating room as a system. Also, the study aims to further characterize the limitations of~     the current surgical sponge counting protocol.~   "
249800|NCT00282724|"~     Lamellar ichthyosis is a congenital disease of the skin with a generalized scaling. The~     primary activity of liarozole is considered to be the inhibition of the degradation of a~     substance called retinoic acid, which is the principal endogenous regulator of growth and~     differentiation of epithelial tissues in mammals. The current study intends to evaluate the~     efficacy and safety in patients with lamellar ichthyosis.~   "
249801|NCT00282711|"~     The purpose of this study is to compare two types of exercise stress testing to find the best~     method for detecting heart disease in women.~   "
249802|NCT00282698|"~     Patients with or without diabetes may have high blood sugar levels due to stress response of~     the body during heart surgery. This study is being done to determine if maintaining normal~     blood sugar levels during open-heart surgery by using intravenous insulin results in a lesser~     incidence of death, wound infections in the chest, disturbances of heart rhythm, kidney~     failure, stroke and prolonged time on the breathing machine (artificial ventilation) within~     30 days after surgery.~   "
249803|NCT00282685|"~     Treatment of patients with diabetic neuropathy by intraarterial progenitor cell~     transplantation.~   "
249804|NCT00282672|"~     The purpose of this study is to determine if the intervention of a 510(k)-cleared~     endoscopically-guided (Halo Ablation systems), ablation system plus anti-secretory therapy is~     better than anti-secretory therapy alone in clearing Barrett's Esophagus.~   "
249805|NCT00282659|"~     The purpose of this study is to determine if magnesium can improve blood pressure,~     cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators~     (ICDs).~   "
249806|NCT00282646|"~     Patients with peripheral artery disease, stage III or IV who are not candidates for~     interventional or operative therapy should be treated with intraarterial progenitor cell~     therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.~   "
249807|NCT00282633|"~     A Comparison of Skin Closure Techniques after Primary Cesarean Delivery. Traci N. Gray, M.D.~     and Peter F. Schnatz, D.O.~      A prospective, observer blinded, randomized, and controlled trial comparing Dermabond closure~     technique to suture closure of skin.~      Study Participants: All women age 18years or older who provide informed consent prior to~     primary Cesarean delivery at Hartford Hospital. Women with vertical skin incisions and or who~     are febrile preop or intraop will be excluded.~      Methods: Qualified participants will then be randomized to skin closure with either Dermabond~     or suture. Surgeon preference will dictate usage of 4-0 monocryl or 4-0 vicryl for skin~     closure for patients randomized to the suture arm.~        -  The circulating nurse will time all skin closures.~        -  The surgeon will complete a 3 question survey immediately postop.~        -  At the 6 week post partum visit, patients and the health care professional will complete~          a brief query regarding cosmetic appeal and pain. A disposable camera will be supplied~          to each provider office and a photo will be taken of the incision.~        -  All photos will be evaluated for cosmesis by physicians who will be blinded to the~          methods of skin closure.~      Primary Outcomes: To compare the time needed to close skin. To compare cosmetic outcome after~     healing~      Secondary Outcomes: Patient Pain scores. Provider and patient satisfaction. Responses to~     questions.~   "
249808|NCT00282620|"~     This study is being conducted to see if magnesium can reduce the number of shocks patients~     with ICDs experience and to see if magnesium supplementation improves patients quality of~     life.~   "
249809|NCT00282607|"~     The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159, an~     orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment~     of subjects with erectile dysfunction (ED).~   "
249810|NCT00282594|"~     We sought to determine if there is a benefit to using an insulin drip to control~     hyperglycemia in the surgical critical care unit for patients who undergo general and~     vascular surgery.~   "
249811|NCT00282581|"~     The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox~     vaccine injections in healthy adults that are 18-35 years of age with HIV infection~   "
249812|NCT00282568|"~     A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable~     kidney transplant patients converted from a Prograf® based immunosuppression regimen to a~     modified release tacrolimus based immunosuppression regimen.~   "
249813|NCT00282555|"~     STU-Na belongs to the proton pump inhibitors (PPI), a group of drugs that reduce gastric~     acidity. PPI are used to treat acid related diseases like erosive or ulcerative esophagitis.~     This trial aims to find out the therapeutic dose of STU-Na required for healing patients with~     erosive or ulcerative esophagitis. One of four dosages of STU-Na (15 mg, 30 mg, 60 mg, or 90~     mg daily), or Esomeprazole 40 mg daily, an already marketed PPI, will be given to patients.~     The attribution to one of the 5 treatment groups will be by chance. Neither the patient nor~     the study physician will know, which treatment is administered to the patient.~   "
249891|NCT00281528|"~     This is a multi-center, open-label, randomized Phase II study in previously untreated~     patients with metastatic breast cancer to evaluate the antitumor activity and safety of~     weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly~     infusion. All patients will also receive concurrent bevacizumab.~   "
249814|NCT00282542|"~     The purpose of this study is to gain knowledge about the result of infusing liver cells,~     carefully matched to blood type, into a subject's body. The hope is that this procedure will~     aid functions of the liver and prevent death, enable a transplant procedure to be carried out~     if a donated liver becomes available, and lessen complications in postoperative recovery.~     There is no guarantee that any of these benefits will be re eived, but even if they are not,~     the hope is that knowledge gained by using this procedure will be of future benefit to others~     who also suffer from liver disease.~   "
249815|NCT00282529|"~     The proposed research is designed to establish lymphedema incidence rates for a varied~     population of breast cancer patients. Patients with breast preservation, mastectomy, sentinel~     lymph node biopsy, axillary dissection and radiation therapy will be included with the goal~     of determining the impact that each of these treatments has on development of lymphedema.~     Establishing incidence in these populations is crucial to the remainder of the study. We~     conduct a two phase study. The first phase will use arm measurements, a symptom survey (The~     Lymphedema and Breast Questionnaire), a functional survey (Disability of the Arm, Shoulder,~     and Hand Questionnaire), and operative and pathology information to create a simple screening~     tool to predict the development of lymphedema. Currently, lymphedema is only diagnosed after~     arm swelling develops. The goal of the screening tool is to identify those patients at~     significantly increased risk for development of lymphedema as compared to the general~     population of breast cancer survivors. Phase 2 of the study will test a lymphedema prevention~     strategy in a high risk population. The goal of this phase is to reduce the incidence of~     lymphedema in those patients that have undergone an axillary node dissection with radiation~     therapy by using a combination of education, a compression sleeve and decongestive exercises.~     If prevention is successful, the development of a screening tool becomes even more important~     to identify those patients that should undergo a prevention regimen.~   "
249816|NCT00282516|"~     OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology~     improves outcomes when compared to in-person, office-based visits.~   "
249817|NCT00282503|"~     The purpose of this study is to compare the safety and efficacy of ECP treatment combined~     with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of~     patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days~     following an allo HPCT.~   "
249818|NCT00282490|"~     The purpose of this study is to perform a randomized controlled investigation of the effect~     of surface nerve stimulation on functional daytime incontinence in children with OAB.~   "
249819|NCT00282477|"~     Bicycle riding is associated with related diverse urogenital symptoms ranging from genital~     numbness to erectile dysfunction (ED). Very little is known about the quality of sperm in~     cyclists and whether a connection exists between erectile dysfunction and azoospermia.~   "
249820|NCT00282464|"~     This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in~     outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are~     required to undergo a washout period of at least 7 days of any prior med.~   "
249821|NCT00282451|"~     This trial is conducted in Africa and Middle East. The objective of the study is to compare~     glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30~     twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in~     subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.~   "
249822|NCT00282438|"~     Sarcoidosis is a disease believed to be due to immune cells, cells which normally protect the~     body, but are now attacking lungs, heart, nerves, or other organs or systems within the body.~     As a result, the affected organs or systems fail to work properly causing difficulty~     breathing; heart failure; inability of the nerves to respond properly causing numbing,~     tingling, pain, and progressive muscle weakness; or other symptoms depending on the organ or~     body system involved. The likelihood of progression of this disease is high. This study is~     designed to examine whether treating patients with high dose cyclophosphamide (a drug which~     reduces the function of the immune system) and ATG (a protein that kills the immune cells~     that are thought to be causing this disease), followed by return of the previously collected~     blood stem cells will stop the progression of sarcoidosis. Stem cells are undeveloped cells~     that have the capacity to grow into mature blood cells, which normally circulate in the blood~     stream. The purpose of the high dose cyclophosphamide and ATG is to destroy the cells in the~     immune system. The purpose of the stem cell infusion is to evaluate whether this treatment~     will produce a normal immune system that will no longer attack the body.~   "
249823|NCT00282425|"~     Scleroderma is disease believed to be due to immune cells, cells which normally protect the~     body but are now causing damage to the body. There has not been any treatment that has been~     effective in treating this disease. The likelihood of progression of the disease to severe~     disability and death is high. This study is designed to examine whether treating patients~     with high dose Cyclophosphamide and Fludarabine (drugs which reduce the function of your~     immune system) and CAMPATH-1H (a protein that kills the immune cells that are thought to be~     causing the disease), followed by return of blood stem cells that have been previously~     collected from patients brother or sister will stop or reverse the disease. The purpose of~     the Cyclophosphamide, Fludarabine and CAMPATH-1H is to decrease immune system. The purpose of~     the stem cell infusion is to restore blood production, which will be severely impaired by the~     Cyclophosphamide, Fludarabine and CAMPATH-1H, and to produce a normal immune system that will~     no longer attack the body.~   "
249843|NCT00282165|"~     In a double blind randomized clinical trial with cross-over design, treatment using~     naratriptan will be compared to placebo within a group of 30 convicts with psychiatric~     disorders such as psychosis or psychopathy with repeated aggressive outbursts resistant to~     conventional psychopharmacologic and other psychotherapeutic treatment. Hypothesis is that~     addition of naratriptan to the individual treatment regime reduces aggression -and improves~     general outcome- as compared to addition of placebo and is well tolerated in this group and~     under these conditions.~   "
249892|NCT00281515|"~     The purpose of this study is to compare the effects of Paclitaxel/Carboplatin and Lonafarnib~     to those of Paclitaxel/Carboplatin in primary treatment of patients with epithelial ovarian~     cancer.~   "
250051|NCT00279409|"~     The purpose of this pilot is to initiate a program of research into the development of~     effective medication techniques to treat those children with ADHD who are referred because~     they are partial or non-responders to standard stimulant treatment.~   "
249824|NCT00282412|"~     Rheumatoid arthritis disease is believed to be due to immune cells, cells that normally~     protect the body and are now causing damage to the body. Risk of death is highest in people~     with twenty or more joints actively involved with disease, positive rheumatoid factor, an~     elevated sedimentation rate (laboratory measures of active inflammation), and patients with~     limitation of daily activities (trouble doing simple things like opening a carton of milk).~     In these high risk patients, life is significantly shortened. Death is usually from heart~     disease, kidney failure, neck dislocation, broken hip bones, or blood clots to the lung. In~     this study we use moderate dose chemotherapy (cyclophosphamide and fludarabine) and~     CAMPATH-1H (a protein that kills the immune cells that are thought to be causing the~     disease), followed by infusion of blood stem cells that have been collected from the~     patient's brother or sister (allogeneic stem cell transplant). The purpose of the moderate~     dose chemotherapy and CAMPATH-1H is to destroy the cells in the immune system and to allow~     the cells from the patient's brother or sister to grow. The purpose of the stem cell infusion~     is to restore blood cell production, which will be severely impaired by the moderate dose~     chemotherapy and CAMPATH-1H, and to produce a normal immune system that will no longer attack~     the body.~   "
249825|NCT00282399|"~     The purpose of this study was to determine which of the doses of decitabine maximizes genomic~     demethylation in patients with Myelodysplastic Syndrome (MDS).~   "
249826|NCT00282386|"~     This study was to compare the effect of 156 weeks of treatment with MK-0966 (Rofecoxib)~     versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside~     (the lining) of the large intestine, also known as the colon) in patients with a history of~     colorectal adenomas.~   "
249827|NCT00282373|"~     The primary objectives of this study are to determine the safety and feasibility of inducing~     mild hypothermia using a non-invasive thermoregulatory device, the Medivance Arctic Sun~     Temperature Management System, in patients resuscitated after cardiac arrest.~   "
249828|NCT00282360|"~     Patients with coronary artery disease have an abnormal cardiac metabolism. The hypothesis of~     this study is that shifting cardiac metabolism from free fatty acids to glucose will improve~     myocardial ischemia~   "
249829|NCT00282347|"~     This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to~     evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF)~     compared with placebo in combination with MMF in subjects diagnosed with International~     Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis.~   "
249830|NCT00282334|"~     The aim of the study is to compare telemedical antihypertensive treatment based on home blood~     pressure monitoring and conventional antihypertensive treatment based on monitoring of blood~     pressure in the doctor's office.~      We want to test the hypotheses that telemedical treatment is more effective in lowering blood~     pressure, provide better quality of life and is more cost-effective.~   "
249831|NCT00282321|"~     We wanted to test urinary concentrating ability and AQP-2 expression in kidney during~     high-protein and high-carbohydrate diet.~   "
249832|NCT00282308|"~     This was a Phase II, randomized, open-label, multicenter study designed to evaluate the~     immune response to vaccines after administration of 1000 mg of rituximab in subjects with~     active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).~   "
249833|NCT00282295|"~     New immunization recommendations in the US include vaccination of adolescents against~     pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the~     Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced~     Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate~     vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the~     same office visit if vaccination with both vaccines is indicated. Therefore, this study is~     designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix~     co-administered with Menactra as compared to the administration of either vaccine alone in~     healthy adolescents 11 - 18 years of age.~   "
249834|NCT00282282|"~     The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how~     effective it is in preventing graft versus host disease (GVHD)in patients that have received~     non-myeloablative peripheral blood stem cell transplantation.~   "
249835|NCT00282269|"~     The purpose of this study is:~        -  To determine the safety and feasibility of performing an international multi-centre~          randomized control trial of early and prolonged hypothermia to improve outcome in~          children with severe traumatic brain injury (TBI).~        -  To determine whether in children with severe traumatic brain injury, prolonged initial~          hypothermia (minimum 72 hours at 32-33 degrees) improves the proportion of good outcomes~          12 months after injury when compared to initial normothermia (36-37 degrees).~   "
249836|NCT00282256|"~     A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable~     pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen~     to a modified release tacrolimus based immunosuppression regimen.~   "
249837|NCT00282243|"~     A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable~     liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression~     regimen to a modified release tacrolimus based immunosuppression regimen.~   "
249838|NCT00282230|"~     A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant~     patients~   "
249839|NCT00282217|"~     The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by~     treatment with sirolimus, may improve renal function in renal transplant recipients with~     chronic allograft nephropathy.~   "
249840|NCT00282204|"~     Antenatal hypnosis is associated with a reduced need for pharmacological interventions during~     childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group~     hypnosis preparation for childbirth in late pregnancy.~   "
249841|NCT00282191|"~     This survey aims to investigate the prevalence of spasticity among adults who live in~     community settings in Davidson County, Tennessee. The treatment of spasticity in those who~     live in community homes could significantly increase a person's quality of life by allowing~     them to participate more independently in activities of daily living, or by making assistance~     easier for caregivers.~   "
249842|NCT00282178|"~     The purpose of this study is to investigate the effect of a 12-week candesartan treatment~     compared with hydrochlorothiazide on insulin sensitivity assessed with hyperinsulinemic~     euglycemic clamp.~   "
249844|NCT00282152|"~     Bilateral subthalamic nucleus deep brain stimulation (B-STN DBS) is one of the most effective~     surgical treatments for PD patients suffering from levodopa-induced motor complications. The~     relatively low incidence of permanent adverse effects and the potential for neuroprotection~     and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio~     of this procedure. Since neuroprotection is best applied early in the disease course when~     there are more surviving neurons, we believe that further investigation of this procedure is~     warranted. The proposed pilot study will provide the necessary data to substantiate the~     safety and tolerability of the procedure as well as provide data for the design of a~     full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and~     effective treatment to slow the progression of PD.~   "
249845|NCT00282139|"~     This is an open-label, flexible dose study designed to evaluate the safety and efficacy of~     aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms~     and with or without ADHD symptoms.~   "
249846|NCT00282126|"~     Osteoporosis, a disease in which the bones become weak and are more likely to break, is a~     major health problem in the United States. Too much acid in the body appears to be linked to~     loss of calcium via urine, bone loss, and muscle breakdown. The purpose of this study is to~     determine the effect of various doses of potassium citrate, a supplement that can neutralize~     acid, on bone density and muscle mass in older, healthy adults.~   "
249847|NCT00282113|"~     The purpose of this study is to see how oral preparations containing both probiotics and~     prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain~     fatty acid content in premature infants. Our hypothesis is that short term growth will be~     improved, the stool will have more healthy bacteria, and the fecal short chain fatty acid~     content will increase in the babies who receive the probiotic/prebiotic combinations compared~     to control groups.~   "
249848|NCT00282100|"~     This research is being done to find how soon the liver cancer may come back and whether~     proteins or genes in tumor, blood or urine can give us clues of early recurrence.~   "
249849|NCT00282087|"~     The purpose of this trial is to study the benefits of giving chemotherapy to women after they~     have had surgical resection of their primary disease and have no evidence of disease~     remaining(known as adjuvant therapy). The major objective of this study is to determine the~     progression free survival. The goal is to prevent relapse or recurrence of their uterine~     leiomyosarcoma.~   "
249850|NCT00282074|"~     In this prospective open armed study we aim to see if bilateral hernia repair using a mesh~     alters the spermatogram (sperm count) or testicular volume.~   "
249851|NCT00282061|"~     This study's first aim is to widen the knowledge of the characteristics of delayed sleep~     phase disorder (DSPS) by focusing on the circadian rhythms of appetite regulation factors and~     their phase relations to the cycles of sleep-wake, melatonin, cortisol and body temperature.~     This study's second aim is to assess the influence of forced morning awakening, as a daily~     struggle faced by DSPS patients, upon the synchronization of these variables in DSPS~     patients. The investigators hypothesize that the chronic incompatibility between the~     endogenous sleep-wake rhythm of the DSPS patients and the morning wakefulness, as a social~     demand, may impair the synchronization between the different rhythms, as findings indicate in~     normal subjects under jet lag. And finally, the third aim of the study is to assess the~     influence of successful treatment with melatonin upon the phase locations of circadian~     rhythms of studied measures and the synchronization between them. These measures will be~     assessed in a controlled study, for 36 hours (sampled every 2 hours) under three distinct~     experimental conditions: first, under free sleep-wake conditions (ad-libitum bedtime and~     arousal); second, under restricted sleep-wake conditions (enforced morning wake-up); and~     finally, after 12 weeks of melatonin treatment.~   "
249852|NCT00282048|"~     To determine the activity and response rate of AG-013736 in patients with advanced and~     refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).~   "
249853|NCT00282035|"~     To determine if Accelerated Partial Breast Irradiation, using 3D CRT, is as effective as~     Whole Breast Irradiation following breast conserving surgery in women with an new~     histological diagnosis of ductal carcinoma in situ only or invasive breast cancer without~     evidence of metastatic disease. Effectiveness will be determined by the rate of ipsilateral~     breast tumour recurrence.~      General objective is to improve the convenience and quality of life of female patients who~     receive breast irradiation.~   "
249854|NCT00282022|"~     RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well VNP40101M works in treating patients with~     recurrent or refractory locally advanced or metastatic small cell lung cancer.~   "
249855|NCT00282009|"~     RATIONALE: Computer-assisted stop-smoking plans and telephone counseling may help people stop~     smoking. It is not yet known which computer-based smoking cessation program is more effective~     with or without telephone counseling in helping smokers quit smoking.~      PURPOSE: This randomized clinical trial is studying two different computer-based smoking~     cessation programs to compare how well they work with or without telephone counseling in~     helping smokers quit smoking.~   "
249856|NCT00281996|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving imatinib mesylate together with gemcitabine may kill more tumor~     cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving imatinib~     mesylate together with gemcitabine and to see how well they work in treating patients with~     locally advanced, metastatic, or recurrent pancreatic cancer.~   "
249885|NCT00281606|"~     Guidelines have continued to list lopinavir/ritonavir as a preferred protease~     inhibitor-containing regimen for HIV-infected individuals. There has recently been increasing~     interest in once daily therapy. While lopinavir/ritonavir has recently been approved as a~     once daily therapy it was associated with considerable diarrhea in those treated with soft~     gel capsules. It is the hope that alternative formulations of lopinavir/ritonavir may provide~     similar pharmacokinetics with improved tolerability. This includes the possibility of using~     liquid or newly released tablets. This study will treat people tolerating their current~     regimen with up to four weeks of each formulation with several assessments of~     pharmacokinetics and tolerability for each.~   "
249857|NCT00281983|"~     RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of~     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either~     kill them or deliver cancer-killing substances to them without harming normal cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving methotrexate, cyclosporine and mycophenolate mofetil after the transplant may stop~     this from happening. Once the donated stem cells begin working, the patient's immune system~     may see the remaining cancer cells as not belonging in the patient's body and destroy them~     (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells~     (donor lymphocyte infusion) may boost this effect.~      PURPOSE: This phase I/II trial is studying the side effects of giving fludarabine together~     with cyclophosphamide and to see how well they work in treating patients who are undergoing~     donor stem cell transplant for B-cell chronic lymphocytic leukemia or Waldenström's~     macroglobulinemia.~   "
249858|NCT00281970|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after~     surgery.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin~     works in treating patients with stage I, stage II, or stage III non-small cell lung cancer~     that has been completely removed by surgery.~   "
249859|NCT00281957|"~     This randomized phase II trial is studying how well giving sorafenib together with either~     temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be~     removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may~     also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known~     whether sorafenib is more effective when given together with temsirolimus or tipifarnib in~     treating patients with malignant melanoma.~   "
249860|NCT00281944|"~     This phase I trial is studying the side effects and best dose of oxaliplatin when given~     together with leucovorin and fluorouracil in treating young patients with advanced solid~     tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~   "
249861|NCT00281931|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some find cancer cells and kill them or carry cancer-killing substances to~     them. Others interfere with the ability of cancer cells to grow and spread. Giving~     fludarabine and cyclophosphamide together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide~     together with rituximab works in treating patients with B-cell prolymphocytic leukemia.~   "
249862|NCT00281918|"~     This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to~     see how well they work compared to fludarabine and cyclophosphamide in treating patients with~     B-cell chronic lymphocytic leukemia.~   "
249863|NCT00281905|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving radiation therapy after chemotherapy may kill any~     remaining tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with or without radiation therapy works in treating children with brain tumors.~   "
249864|NCT00281892|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Darbepoetin alfa may cause the body to make more red blood cells. It is not yet known whether~     fludarabine is more effective with or without darbepoetin alfa in treating chronic~     lymphocytic leukemia.~      PURPOSE: This phase III trial is studying fludarabine to see how well it works when given~     together with or without darbepoetin alfa in treating older patients with chronic lymphocytic~     leukemia.~   "
249865|NCT00281879|"~     RATIONALE: A peripheral stem cell transplant or an umbilical cord blood transplant from a~     donor may be able to replace blood-forming cells that were destroyed by chemotherapy or~     radiation therapy. Giving an infusion of the donor's white blood cells (donor lymphocyte~     infusion) after the transplant may help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells can make an immune response~     against the body's normal cells. Methotrexate, cyclosporine, tacrolimus, or~     methylprednisolone may stop this from happening.~      PURPOSE: This clinical trial is studying how well a donor stem cell transplant or donor white~     blood cell infusions work in treating patients with hematologic cancer.~   "
249866|NCT00281866|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with~     recurrent and/or metastatic head and neck cancer.~   "
249867|NCT00281853|"~     RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve~     function may help doctors plan treatment and help patients live more comfortably.~      PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving~     chemotherapy or biological therapy for cancer.~   "
249886|NCT00281593|"~     To identify dose combinations of telmisartan and ramipril that are more effective in reducing~     diastolic blood pressure than each of the respective monotherapies in patients with Stage I~     or II hypertension.~   "
249887|NCT00281580|"~     To demonstrate that Micardis and Norvasc when used together are more effective at lowering~     blood pre ssure.~   "
249888|NCT00281567|"~     Comparison of lung function response between tiotropium inhalation solution and Spiriva~     HandiHaler.~   "
249889|NCT00281554|"~     This study is designed to determine the safety of RSD1235 in patients with atrial~     fibrillation.~   "
249868|NCT00281840|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such~     as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving bevacizumab together with docetaxel and radiation therapy may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel~     and radiation therapy works in treating patients with stage III or stage IV head and neck~     cancer.~   "
249869|NCT00281827|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.~     Giving carboplatin and gemcitabine together with thalidomide before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together~     with thalidomide works in treating patients who are undergoing surgery for stage II or stage~     III non-small cell lung cancer.~   "
249870|NCT00281814|"~     RATIONALE: Questionnaires that measure coping may improve the ability to plan supportive care~     for patients undergoing donor bone marrow transplant.~      PURPOSE: This clinical trial is studying coping in patients who are undergoing a donor bone~     marrow transplant.~   "
249871|NCT00281801|"~     RATIONALE: Questionnaires that measure quality-of-life may improve the health care team's~     ability to plan supportive care for patients undergoing donor bone marrow transplantation.~      PURPOSE: This clinical trial is studying quality of life in patients who are undergoing donor~     bone marrow transplantation.~   "
249872|NCT00281788|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, carboplatin, and paclitaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when~     given together with carboplatin, paclitaxel, and radiation therapy in treating patients with~     esophageal cancer or gastroesophageal junction cancer.~   "
249873|NCT00281762|"~     We wanted to test the hypothesis that prostaglandin inhibition reduces the down regulation of~     u-AQP-2 induced by fasting~   "
249874|NCT00281749|"~     A telephone call from a physician taking care of a patient in the hospital to a physician in~     the long term care setting at the time of discharge can improve transitional care for elderly~     patients. We believe direct communication between physicians can reduce re-hospitalizations,~     medication errors, morbidity and mortality. No studies have been done that involve~     physician-to-physician sign-outs after hospital discharge to the nursing home. In our study,~     we would like to address the breakdown in the transfer of information to the nursing home~     setting.~   "
249875|NCT00281736|"~     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells.~     The drug becomes active when it is exposed to light, and kills tumor cells. HPPH may be~     effective in killing precancerous cells and tumor cells.~      PURPOSE: This randomized phase II trial is studying how well photodynamic therapy with HPPH~     works in treating patients with precancerous esophageal conditions or stage 0 or stage I~     esophageal cancer.~   "
249876|NCT00281723|"~     Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition.~     Despite advances in therapeutic means there is still necessary to find a way to alleviate the~     local pain and discomfort induced by the mucosal ulceration.~      The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in~     the treatment of RAS.~      Participants in the study will be examined for oral lesions, will be instructed how to apply~     the oral-tablet, and will be interviewed during the follow-up period up to one week after the~     application.~   "
249877|NCT00281710|"~     We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting~     healthy humans~   "
249878|NCT00281697|"~     This phase III, multicenter, randomized, placebo-controlled, blinded trial is designed to~     evaluate the efficacy and safety of bevacizumab when combined with standard chemotherapy~     compared with chemotherapy alone in subjects with previously treated metastatic breast~     cancer.~   "
249879|NCT00281684|"~     This clinical trial is a multi centre, randomised, single-blind, parallel group,~     placebo-controlled, single oral dose study with a positive control arm. Patients previously~     scheduled for 3rd molar tooth extraction, who are otherwise healthy, will be recruited. Upon~     completion of surgery, e.g. prior to established pain, patients will be randomised to~     treatment (SB-706598, placebo or co-codamol) and dosed with the study medication~   "
249880|NCT00281671|"~     The purpose of this study is to determine the effects of nesiritide on urine output and~     hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data~     will also be obtained.~   "
249881|NCT00281658|"~     This is a Phase III study designed to evaluate the response (shrinkage or lack of growth) of~     tumors of lapatinib plus paclitaxel compared to paclitaxel plus placebo as first line~     metastatic treatment in women and men who have metastatic breast cancer. Patients will be~     evaluated for safety and efficacy. Countries include China, Hong Kong, Thailand, Brazil and~     Peru.~   "
249882|NCT00281645|"~     The primary objective of the study is to evaluate the safety and efficacy of bicifadine 400~     mg BID for up to one year in patients with moderate to severe chronic low back pain.~      The secondary objectives are to compare the long-term safety of bicifadine to standard of~     care therapy, to evaluate the safety of bicifadine following discontinuation of dosing, and~     to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not~     tolerate bicifadine 400 mg BID.~   "
249883|NCT00281632|"~     This study was designed to find out how effective and safe GW786034, is in the treatment of~     epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to~     standard treatment.~   "
249884|NCT00281619|"~     The purpose of this study is to determine how fast children, who have had a recent kidney~     transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their~     prescribed dose. The results may lead to better dosing based on individual needs.~   "
249893|NCT00281502|"~     The study will be conducted in two phases. Phase A will evaluate the contribution of~     bacterial overgrowth and colonic inertia to development of Hepatic Encephalopathy (HE)in 50~     ambulatory subjects with HE and hepatitis C cirrhosis. This phase will include a Screening~     and Evaluation Visit.~      Phase B will evaluate the effect of rifaximin on bacterial outgrowth and severity of HE in 20~     of the subjects enrolled in Phase A who have a somewhat greater degree of encephalopathy.~      The purpose of this study is to evaluate the following:~        1. the relationship between bacterial overgrowth and the presence and severity of HE in~          patients with hepatitis C cirrhosis;~        2. the effectiveness and tolerability of rifaximin relative to placebo in treatment of HE~          associated with hepatitis C cirrhosis;~        3. the relationship between bacterial overgrowth and the presence and severity of HE before~          and after rifaximin treatment.~   "
249894|NCT00281489|"~     The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and~     Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of~     patients remembering being awake during surgery. The BIS monitor may be able measure how~     asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be~     compared with using the concentration of anesthetic gas to guide anesthesia.~   "
249895|NCT00281476|"~     The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone~     metabolisme and biochemical markers of disease in Multiple Myeloma~   "
249896|NCT00281463|"~     The purpose of this three phase study is to evaluate a Pushrim Activated Power Assist~     Wheelchair (PAPAW). Phase I will examine whether the steady-state, metabolic energy~     efficiency for propelling a manual wheelchair with and without the device will be~     significantly different. In Phase II, wheelchair users will evaluate the PAPAW over~     activities of daily living course to determine its usability and acceptability and to~     identify areas for future development. Finally, in phase III, comparison of activities of~     daily living in the community will be made between the subjects when using their personal~     wheelchair and a PAPAW.~   "
249897|NCT00281450|"~     This study will explore the possible effect of a tailored educational intervention towards~     general practitioners, in order to reduce inappropriate prescription patterns for elderly~     patients > 70 years.~   "
249898|NCT00281437|"~     The current study was designed to investigate the influence of choice of exercise program on~     exercise adherence. The two exercise programs included 1) traditional exercise at a fitness~     centre or 2) lifestyle exercise-walking using a pedometer to track steps. Biological and~     psychological indicators were examined to investigate the effect of choice in a sample of~     sedentary adults.~   "
249899|NCT00281424|"~     The purpose of the project was to test the widely endorsed assumption that pedometers produce~     or encourage more physical activity participation in the form of walking. The investigators~     hypothesized that pedometers would not increase the amount of walking cardiac patients~     participated in after their cardiac rehabilitation program compared to patients without~     pedometers.~   "
249900|NCT00281411|"~     After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor~     the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm~     diameter and the presence of endoleaks is evaluated with CT angiography yearly after~     Endovascular Aneurysm Repair (EVAR).~      The aim of this study is to investigate the value of MRA examinations for the follow-up of~     these patients. The advantages of MRA with respect to CTA are no use of ionizing radiation,~     use of less nephrotoxic contrast agents.~   "
249901|NCT00281398|"~     Homelessness is a significant problem in Canada, and many homeless people will seek routine~     care in the Emergency Department (ED) as a result of barriers to access. There is a paucity~     of information in the literature concerning the attitudes of health care workers towards~     homeless patients in the ED setting, although there is ample reason to believe that these~     attitudes may be suboptimal. In the absence of formal teaching regarding issues of~     homelessness, medical students have been shown to develop increasingly negative attitudes~     towards this vulnerable population. It is therefore important to better delineate the~     attitudes of ED physicians towards homeless persons and to develop an emergency medicine~     curriculum that helps sensitize physicians to the needs of this already disadvantaged~     population.~   "
249902|NCT00281385|"~     This study is a comparison of the traditional prescription versus the lifestyle exercise~     prescription in sedentary adults over 6 months. Biological and psychological parameters will~     be assessed over the 6 month study. Biological indicators will be assessed pre and post~     including body composition, muscular strength, endurance, and flexibility, aerobic fitness,~     and blood tests. Psychological parameters will be assessed pre, mid, and post including~     self-efficacy, motivation, need satisfaction, physical self-description, leisure-time~     exercise, as well as all constructs from the thepry of planned behaviour.~   "
249903|NCT00281372|"~     Evaluation of sexual functioning of patients at the Sexual Medical Center, at Sheba Medical~     Center in Israel. Sexual functioning shall be compared with their dental behavior.~      Hypothesis: a positive association will be found.~   "
249904|NCT00281359|"~     This study is looking at new ways to stretch knee contractures in children with cerebral~     palsy using a specially designed splint.~   "
249905|NCT00281346|"~     Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with~     transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses.~     Blinded evaluation and comparison with coronary angiography: presence and location of~     stenoses, and head to head comparison of clinical value and patient classification.~   "
249906|NCT00281333|"~     Hemophilia patients tend to lower their physical activity level due to the fear of increasing~     bleeding episodes. Although recent literature has shown that with routine muscle~     strengthening and physical activity, the frequency and duration of bleeds was reduced. Our~     study has built a routine of strength training exercises and karate training. The study is~     built in two stages, each stage being three months. The participants fill out a bleeding~     diary that includes information from the previous six months. It includes place of bleed,~     duration, pain level, spontaneous or traumatic bleed, factor replacement and joint~     limitation. Before the exercise, the participants are tested for muscle strength and~     endurance. The bleeding diary will be filled out following the first three months and the~     second phase as will the muscle strength and endurance. We are hoping to see a drastic~     reduction of bleeding episodes occurring especially from spontaneous bleeds.~   "
249908|NCT00281307|"~     Many beneficial effects of vitamin E have been described, but vitamin E supplementation by~     mouth has not been effective in the treatment of nasal symptoms and allergic rhinitis. The~     investigators will evaluate the effect of vitamin E directly applied to the lining of the~     nose in individuals with moderate to severe rhinitis by symptom questionnaires.~   "
249909|NCT00281294|"~     To evaluate the efficacy of fontolizumab in subjects with active rheumatoid arthritis as~     determined by a 50% improvement of an American College of Rheumatology criteria (ACR50)~     response at Week 14 (Stage A of study).~   "
249910|NCT00281281|"~     1. Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug~          toxicity.~        2. There is limited data on the change of vancomycin pharmacokinetics in patients who need~          extracorporeal membrane oxygenation (ECMO).~        3. This control trial is to understand:~             1. whether the pharmacokinetics of vancomycin is influenced by the use ECMO~             2. design the most appropriate dose of vancomycin in adult patients using ECMO.~   "
249911|NCT00281268|"~     To assess rapidly innovative treatment methods in patients with adult respiratory distress~     syndrome as well as those at risk of developing ARDS.~   "
249912|NCT00281255|"~     This study will determine whether an acute infusion of intravenous allopurinol improves the~     inotropic response to dobutamine in patients with idiopathic dilated cardiomyopathy (DCM) as~     measured by cardiac magnetic resonance imaging (CMR).~   "
249913|NCT00281242|"~     The purpose of this study is to determine whether there is a statistical association between~     changes in sputum serial levels of two cytokines, interleukin (IL)-17 and IL-6, during the~     treatment course of a severe acute exacerbation of chronic obstructive pulmonary disease~     (AE-COPD) and during the clinical course itself (i.e., rate of recovery or potential~     complicated course). AE-COPD is defined as an episode requiring emergency room (ER)~     evaluation.~   "
249914|NCT00281229|"~     The purpose of this study is to determine whether the lungs of individuals with chronic~     obstructive pulmonary disease (COPD) contain resident memory T lymphocytes that can produce a~     combination of cytokines that induce the symptoms of an acute exacerbation of COPD (AE-COPD).~     Specifically, the study will determine cell-surface receptors of lung T cells in comparison~     with blood T cells from the same subject, and will examine anti-CD3-activated blood or lung T~     cells for interleukin (IL)-6 and interferon-gamma production in response to IL-18, and for~     IL-17A production in response to recombinant IL-23.~   "
249915|NCT00281216|"~     The purpose of this study is to determine whether there is a statistical association between~     the changes from baseline in the levels of two cytokines interleukin (IL)-17A and IL-6 in the~     sputum of patients with chronic obstructive pulmonary disease (COPD) and the severity of~     acute exacerbations of COPD (AE-COPD). These sputum cytokine levels are taken as measures of~     the adaptive immune response (IL-17A) and the innate immune response (IL-6), respectively.~     Sputum will be collected either spontaneously or will be obtained by induction; cytokine~     levels will be measured by ELISA. The primary analysis, comparisons of sputum cytokine levels~     between clinical states, will be done using random effects modeling.~   "
249916|NCT00281203|"~     This study group forms the normal subject control group in an experiment designed to~     determine whether the alveolar macrophages (AMø) of patients with chronic obstructive~     pulmonary disease (COPD) show abnormal responsiveness to bacterial and viral products.~     Specifically, the study will determine the dose-response characteristics of AMø for~     production of interleukin (IL)-6, IL-18, and IL-23 (pro-inflammatory cytokines) on~     stimulation by purified lipopolysaccharide, a synthetic lipopeptide (PAM3-Cys), or poly I:C.~     These stimuli mimic the response to Gram-negative bacteria, Gram-positive bacteria, and RNA~     viruses, respectively. Results of the AMø from these healthy volunteers will be compared with~     AMø of COPD patients and smokers (or ex-smokers) with normal pulmonary function; those~     samples are being obtained during clinically indicated bronchoscopies under a separate~     consent form.~   "
249917|NCT00281190|"~     The purpose of this study is to determine whether the alveolar macrophages (AMø) of patients~     with chronic obstructive pulmonary disease (COPD ) show abnormal responsiveness to bacterial~     and viral products, relative to smokers with normal pulmonary function. Participation in this~     study will be offered to patients already scheduled to undergo a bronchoscopy for clinical~     indications.~   "
249918|NCT00281177|"~     The purpose of this study is to characterize the relationship of social stress, coping, and~     self-regulatory health behaviors in the context of asthma disparities among African American~     and low income populations.~   "
249919|NCT00281151|"~     The purpose of this study is to determine the mechanisms underlying the disparities in asthma~     and to improve asthma care in pregnant women, a targeted group at high risk for~     asthma-specific maternal and perinatal complications.~   "
249920|NCT00281138|"~     To reduce disparities in asthma among Latino children.~   "
249921|NCT00281125|"~     This is an open-label, two-arm, multicenter Phase IA/II dose-escalation study of PTK787 in~     combination with Pemetrexed alone (Cohort 1) or Pemetrexed and Cisplatin (Cohort 2).~      This study is designed to determine the maximum tolerated dose (MTD) and dose limiting~     toxicity (DLT) of PTK787 when administered in combination with Pemetrexed or Pemetrexed and~     Cisplatin, and to characterize the safety, tolerability, biologic activity, and PK profile of~     PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas.~   "
249922|NCT00281112|"~     To evaluate asthma morbidity in low-income, African-American children and adults with asthma.~   "
249923|NCT00281099|"~     The purpose of the study is to compare two device settings (sets of instructions) used by the~     ICD. The Implantable Cardiac Defibrillator (ICD) can be set to use one wire (top or bottom~     of the heart) or two wires (top and bottom). The study will compare how much time either ICD~     wire is used by the ICD and the status of congestive heart failure.~   "
249924|NCT00281086|"~     To address the problems of disparities in asthma care and morbidity by examining the~     influence of environmental/genetic factors and stress on the development of asthma.~   "
249969|NCT00280488|"~     The primary goal of this study is to test the efficacy of a brief intervention that includes~     the patient and a significant other, relative to an intervention including the patient only,~     for reducing alcohol use and alcohol-related problems among trauma patients.~   "
249970|NCT00280475|"~     The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery~     (SRS) in the patients who received surgical resection for brain metastases in comparison with~     postoperative whole brain radiation therapy (WBRT).~   "
249925|NCT00281073|"~     This is a sequential phase 1 and phase 2 study to evaluate the efficacy of intracardiac~     echocardiography to detect septal and left atrial pathology as compared to transesophageal~     echocardiography (Phase 1) and its value in a management strategy for immediate cardioversion~     during cardiac catheterization procedures in patients with atrial fibrillation as compared to~     a conventional strategy delaying cardioversion till full anticoagulation is established for a~     three weeks (Phase 2). Phase 1 will enroll 100 patients at 12 centers; these patients will be~     undergoing clinically indicated TEE & cardiac catheterization procedures. After review of~     Phase 1 results by an independent DSMB & the investigators that establish efficacy of ICE,~     Phase 2 will be initiated. Phase 2 will enroll 300 patients in 15 centers; these patients~     with atrial fibrillation will be undergoing clinically indicated cardiac catheterization~     procedures and have a clinical indication for cardioversion. Patients will be randomized to~     ICE guided cardioversion strategy or a conventional strategy employing three weeks of full~     anticoagulation before cardioversion. ICE imaging will be used to identify a low risk group~     for immediate cardioversion. A composite primary study endpoint that will include mortality~     and major morbidity including stroke and bleeding complications will be used.~      This study will examines two hypotheses in AF patients undergoing invasive cardiac~     procedures:~      Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of left atrial~     pathology or septal defects that can predispose patients to stroke. This will be evaluated~     during the Phase I component of the study.~      Hypothesis 2: That ICE can identify low risk patients in whom immediate cardioversion during~     the procedure is safe and comparably effective to electrical cardioversion performed based on~     a conventional strategy of a minimum of 3 weeks of preceding anticoagulation therapy. Low~     risk patients are expected to have an acceptably low incidence rate of stroke, transient~     ischemic attack (TIA), peripheral embolism, and major hemorrhagic events following electrical~     cardioversion. This will be evaluated during the Phase II component of the study, after the~     Phase I objective is achieved.~   "
249926|NCT00281060|"~     Minimal invasive treatment (called endovascular) of the arteries of the lower limb remains~     problematic, because recurrent disease (restenosis) frequently leads to recurrent symptoms.~     As yet, balloon angioplasty remains the recommended strategy to revascularize the superficial~     femoral artery (artery of the thigh). We investigated whether the use of a vascular~     endoprosthesis (stent) improves patients´ outcome.~      Study hypothesis: Primary stenting with self expanding nitinol stents may improve patency~     after endovascular treatment of superficial femoral artery obstructions compared to balloon~     angioplasty with optional stenting.~   "
249927|NCT00281047|"~     FP-10 is a food ingredient derived from milk casein. FP-10 can inhibit H. pylori to attach to~     the gastric epithelium. FP-10 has been made clear to decrease the intragastric urease~     activity (which is assumed to be produced by H. pylori) measured by the urea breath test.~     FP-10 can also detach H. pylori from gastric epithelium. We have hypothesized that FP-10~     increases the eradication rates by a triple therapy with a proton pump inhibitor,~     amoxicillin, and clarithromycin.~   "
249928|NCT00281034|"~     1. To survey the health-related quality of life using the SF-36v2 score of patients with~          chronic brain infarction in Japan~        2. Chronic brain infarction in Japan is better than EU/USA~   "
249929|NCT00281021|"~     The purpose of this study is to determine the potential benefit of adding Digoxin to~     erlotinib (Tarceva) treatment for patients with non-small cell lung cancer.~   "
249930|NCT00281008|"~     The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012~     (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia~   "
249931|NCT00280995|"~     The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 as~     add-on therapy in subjects with Homozygous Familial Hypercholesterolemia~   "
249932|NCT00280982|"~     Exploiting the immunostimulatory capacities of dendritic cells holds great promise for cancer~     immunotherapy. A mouse model for malignant mesothelioma allowed us to prove that autologous~     dendritic cells presenting tumor antigens were very effective by (partly) inhibiting tumor~     growth. This study will test the feasibility and safety of a clinical trial using autologous~     DC as a therapeutic adjuvant for the treatment of malignant pleural mesothelioma.~   "
249933|NCT00280969|"~     A selection study in treatment naive HIV patients to compare the virologic success rate of~     once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and~     abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen~     will be hired to the comparative study to the current first line regimen (tenofovir plus~     lamivudine plus efavirenz)~   "
249934|NCT00280956|"~     The primary objective of this study is to evaluate the long-term tolerability and safety of~     natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn's~     Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307.~   "
249935|NCT00280943|"~     Osteoporotic fractures of the hip are a major cause of admission to long-term care~     facilities. Such fractures put patients at high risk for further fractures, pain and~     disability. Current data show that many patients in long-term care facilities do not receive~     FDA medications for their osteoporosis. This trial will test whether a multi-model~     intervention (which provides feedback about provider use of osteoporosis medications,~     information about osteoporosis, and currently approved osteoporosis medications)directed at~     physicians, other health care providers, and nurses will improve the number of prescriptions~     written for FDA approved medications for osteoporosis treatment.~   "
249936|NCT00280930|"~     The purpose of this study to see what happens to breast density in healthy postmenopausal~     women after treatment with letrozole in one year, compared with treatment with placebo for~     one year. Other goals of the study include determining if there is a connection between~     estrogen level and breast density for women in the study and collecting information about the~     quality of life of those taking part in the study.~   "
249937|NCT00280917|"~     This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory~     agent, will improve the clinical condition of patients with rheumatoid arthritis who still~     have active joint inflammation despite taking methotrexate for at least 6 months.~   "
249938|NCT00280904|"~     The purpose of this Registry is to compare shunt/catheter-related infection rates among~     various shunt systems when used according to hospital standard of care to treat~     hydrocephalus.~   "
249939|NCT00280891|"~     To describe the charactersitics of patients with advanced head and neck cancer treated with~     palliative intent and determine outcome in terms of symptom control and toxicity~   "
249940|NCT00280878|"~     This is a Phase II pilot study evaluating the safety of a risk-adjusted outpatient-based~     approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim)~     and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim) in combination with~     Rituximab (R-VGF/R-F-GIV).~   "
249941|NCT00280865|"~     This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label~     pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in~     patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone~     during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo~     single blind run in period followed by a 12-week double blind treatment period and a 3-week~     follow-up period~   "
249943|NCT00280826|"~     This study examined the safety and potential efficacy of the monoclonal antibody efalizumab~     (Raptiva) for treating sight-threatening uveitis (eye inflammation). Efalizumab controls the~     activity of white blood cells called lymphocytes that cause inflammation. The drug is~     currently approved in the United States to treat patients with moderate to severe psoriasis.~      Participants 18 and older with sight-threatening intermediate or posterior uveitis of at~     least 3 months duration, causing persistent macular edema in one or both eyes, were eligible~     for this study. The uveitis required treatment with at least 20 milligrams per day of~     prednisone, or the equivalent, or a combination of two or more anti-inflammatory treatments~     such as prednisone, methotrexate, cyclophosphamide, cyclosporine, etc.~      Participants underwent the following tests and procedures:~        -  Medical history and physical examination.~        -  Weekly efalizumab treatment.~        -  Weekly eye examination, including measurement of vision and pressure in the eyes,~          dilation of the eyes and examination of the front and back parts of the eye.~        -  Weekly blood tests to measure the number and types of cells in the blood and to check~          for signs of inflammation and treatment side effects. At some visits, blood samples were~          collected to measure how much efalizumab remains in the blood and whether the body has~          developed an immune response to the medicine.~        -  Blood draw at enrollment and at 2 and 4 months for research tests to examine how~          participants' immune response was operating.~        -  Fluorescein angiography at enrollment and 1 and 3 months after enrollment, unless~          additional tests are needed, for medical management. This test checked for abnormalities~          of eye blood vessels. A yellow dye was injected into an arm vein and travels to the~          blood vessels in the eyes. Pictures of the retina (the back portion of the eye) were~          taken with a special camera that flashes a blue light into the eye. The pictures show~          whether any dye has leaked from the vessels into the retina, indicating possible~          abnormalities.~        -  Monthly pregnancy test for women who could become pregnant.~      Participants returned for treatment and clinic visits weekly for 16 weeks. After 16 weeks,~     participants whose macular edema had decreased and whose vision may have improved were~     offered to continue the injections.~   "
249944|NCT00280813|"~     The purpose of the study is to evaluate a new treatment to help patients who have problems~     because of their use of alcohol. The treatment is called Behavioral Treatment for Alcohol~     Abuse in Schizophrenia (BTAAS).We are interested in determining whether BTAAS is more~     effective in reducing use than a supportive control treatment.~   "
249945|NCT00280800|"~     Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally~     effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances,~     objective vigilance, and it is cost-effective compared to conventional fixed continuous~     positive airway pressure.~   "
249946|NCT00280787|"~     Patients enrolled on this study will have been diagnosed with non-small cell lung cancer~     which cannot be removed by an operation. The standard treatment for this disease is a~     combination of chemotherapy and radiation therapy; however, the best way to combine these~     treatments is not known. This study will examine if the combination of chemotherapy and~     radiotherapy has an increased effect on slowing tumor growth with the addition of a drug~     called ZD1839.~      In this study, chemotherapy will be given initially (induction therapy) to try to control the~     spread of the cancer. Then radiation and chemotherapy will be given together. Receiving~     chemotherapy at the same time as radiation treatments can enhance the effect of the~     radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on~     cancer cells, ZD1839 has shown an additive effect when used in combination with radiation.~     ZD1839 has also been shown to slow or stop growth in tumors.~      The purpose of this study is to determine the side effects and effectiveness of using ZD1839~     when used with radiation in this treatment regimen (induction chemotherapy followed by~     combination chemotherapy, ZD1839, and radiation therapy).~   "
249947|NCT00280774|"~     The purpose of this research is to determine if patients on corticosteroids who are given~     memantine will show improvement in memory compared to those receiving placebo (an inactive~     substance). This research also seeks to determine if such patients, when given memantine,~     will experience improvement in manic/hypomanic symptoms (feelings of agitation,~     overexcitement, or hyperactivity) and/or depressive symptoms. Subjects will be randomized to~     a crossover trial of memantine and placebo for 8 weeks, followed by a 4 week washout and then~     8 more weeks of the study medication. Memantine and placebo will start at 5 mg/day for one~     week, increased to 5 mg twice a day in the second week. During the third week patients will~     take 10 mg in the morning and 5 mg in the evening. At weeks 4-8, patients will take 10 mg~     twice a day. One 8 week course of study medication will be memantine and the other 8 week~     course of study medication will be placebo, both assigned in a random fashion.~   "
249948|NCT00280761|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors understand how patients respond to treatment.~      PURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer undergoing~     chemotherapy and radiation therapy.~   "
249949|NCT00280748|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Pemetrexed may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     radiation therapy together with pemetrexed may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving whole-brain radiation therapy~     together with pemetrexed works in treating patients with brain metastases from non-small cell~     lung cancer.~   "
249950|NCT00280735|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells~     that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel~     works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.~   "
249951|NCT00280722|"~     The purpose of this study is to investigate the feasibility of carrying out a full scale~     randomised controlled trial to compare the effects of giving additional information versus no~     additional information to patients prior to their first oncology appointment.~      Hypothesis: Patients with some awareness of research provided prior to clinic appointment in~     oncology and aware of the possibility of being invited to take part in a clinical trial are~     more likely to agree to participate.~   "
249952|NCT00280709|"~     The primary purpose is to compare patency of two different types of biliary metal stents,~     i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine~     frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and~     cholangitis.~   "
249953|NCT00280696|"~     A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory~     trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in~     patients from 16 to 65 years with epilepsy suffering from partial onset seizures.~   "
250039|NCT00279565|"~     This randomized, single-center, controlled study is designed to evaluate the safety,~     tolerability, and efficacy of treatment with Peg-Intron with Rebetol in methadone or~     buprenorphine maintenance patients with hepatitis C.~   "
249954|NCT00280683|"~     Nitric oxide is an important marker of airway inflammation in asthma. Nitric oxide may have a~     protective role in patients with moderate to severe asthma. The investigators believe that a~     natural amino acid, L-arginine, that augments nitric oxide levels can decrease asthma~     exacerbations and improve the asthma care of moderate to severe asthma patients.~      This study is a randomized, placebo controlled trial in which subjects will receive either 3~     months of L-arginine supplementation or a placebo. The investigators will monitor subjects'~     symptoms, the number of asthma exacerbations, and lung function. In addition, we will draw~     blood, obtain induced sputum samples and measure exhaled breath nitric oxide levels at each~     monthly visit.~   "
249955|NCT00280670|"~     This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT)~     program for treating anxiety symptoms, social problems, and adaptive behavior deficits in~     children with autism spectrum disorders.~   "
249956|NCT00280657|"~     The purpose of the study is to determine safety and efficacy of an oral contraceptive in~     treating acne papulopustulosa.~   "
249957|NCT00280644|"~     Study objectives:~        -  To provide more insight on the modulation of inflammation and matrix degrading factors~          in serum and urine by leflunomide in early , active patients with RA and to validate the~          sensitivity of DEMRI (Dynamic Enhanced Magnetic Resonance Imaging) in detecting~          inflammatory changes in active RA in response to treatment with leflunomide~        -  Effect of leflunomide therapy on physical function improvement and Quality of life~   "
249958|NCT00280631|"~     The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in~     patients with Myelodysplastic Syndrome (MDS)~   "
249959|NCT00280618|"~     Primary:~        -  To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated~          with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin~      Secondary:~        -  Safety and tolerability of this regimen in these patients~   "
249960|NCT00280605|"~     The aim of the study is to collect, under daily practice conditions, clinical data on the~     safety profile and the efficacy of a new formulation of alfuzosin administered once daily in~     patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia~     (BPH).~   "
249961|NCT00280592|"~     Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these~     patients are prone to have recurrent urinary tract infections. Cranberry has been~     traditionally used for the treatment and prophylaxis of urinary tract infections but there is~     no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this~     disease. The aim of our study is to assess the efficacy and safety of cranberry in the~     prophylaxis of urinary tract infections in patients with multiple sclerosis with a~     prospective randomized, double-blind and placebo-controlled clinical trial.~   "
249962|NCT00280579|"~     Aim: To determine the incidence of cyanide poisoning in fire victims.~      20 consecutive patients will have the rest of their blood sample analyzed for cyanide.~   "
249963|NCT00280566|"~     The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue~     to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or~     mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the~     regimen.~   "
249964|NCT00280553|"~     The incisions used in abdominal surgery can be quite painful, requiring strong pain~     medications. A new pain pump that trickles small amounts of local freezing into the incision~     has been developed that helps numb the area so that the patient does not feel the pain for~     two to five days after surgery.~      The main research question is whether use of the pain pump will result in decreased hospital~     length of stay. The research is important because if the pain pump is found to be effective,~     it can substantially decrease the length of stay. Areas to be studied include hospital length~     of stay, patient's comfort post-operatively, and post-operative complications.~   "
249965|NCT00280540|"~     This is a double-blind study to evaluate the reduction in systolic blood pressure using a~     therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg~     compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).~   "
249966|NCT00280527|"~     It is known that a vast majority of patients seeking a bariatric surgery weight reduction~     procedure have non-alcoholic fatty liver disease (NAFLD), while a smaller subset of patients~     within this group have a more serious liver problem known as nonalcoholic steatohepatitis~     (NASH). NASH is a serious liver disease that can lead to cirrhosis, liver failure and~     ultimately liver transplantation. The purpose of this study is to explore the effects of~     bariatric surgery on the progression of NASH. The investigators also hope to gain insight~     into which genes may be responsible for the development of NAFLD and NASH. The knowledge~     gained from this study will advance the field of fatty liver disease and help design rational~     treatments to prevent disease progression.~   "
249967|NCT00280514|"~     Penetration of cefpirome and moxifloaxacin into abscess fluid of humans will be tested.~     Patients with an abscess scheduled for drainage will receive study drugs (single or multiple~     dose), pus samples and plasma samples will be collected and analyzed by High pressure liquid~     chromatography (HPLC). Pharmacokinetics of the study drugs in pus and plasma will be~     determined using a pharmacokinetic model.~   "
249968|NCT00280501|"~     There is evidence from a variety of animal studies that choroidal blood flow is under neural~     control. By contrast, only little information is available from human studies. Recent results~     indicate that a light/dark transition is associated with a reduction in choroidal blood flow~     due to an unknown mechanism. We have shown that during unilateral dark/light transitions both~     eyes react with choroidal vasoconstriction strongly indicating a neural mechanism responsible~     for the blood flow changes.~      Dopamine has been discussed as a chemical messenger for light adaptation. However,~     dopaminergic effects in the eye are not restricted to synaptic sites of release, but dopamine~     also diffuses to the outer retinal layers and pigment epithelium. Accordingly, dopaminergic~     effects also include a modulatory role on retinal vessel diameter and animal studies provide~     evidence for vasodilatory effects in the choroid. There is evidence that during darkness~     retinal and choroidal dopamine levels decrease. Accordingly, dopamine could provide a~     modulatory input to the light/dark transition induced changes of choroidal circulation. The~     aim of the present study is to test this hypothesis.~   "
249971|NCT00280462|"~     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in~     perfusion pressure. For a long time it had been assumed that the choroid is a strictly~     passive vascular bed, which shows no autoregulation. However, recently several groups have~     identified some autoregulatory capacity of the human choroid. In the brain and the retina the~     mechanism behind autoregulation is most likely linked to changes in transmural pressure. In~     this model arterioles change their vascular tone depending on the pressure inside the vessel~     and outside the vessel. In the choroid, several observations argue against a direct~     involvement of arterioles. In a previous project we were able to identify that the nitric~     oxide (NO) - system as well as the endothelin system are involved in choroidal blood flow~     regulation during isometric exercise.~      In the present study autoregulation of the choroid during isometric exercise will be~     investigated and the pressure/flow relationships will be observed in the absence or presence~     of a calcium antagonist - nifedipine.~   "
249972|NCT00280449|"~     This study will examine the effects of having a case manager help PHAs access and use health,~     social services and practical resources that are helpful to their needs as compared to the~     usual more PHA self-managed approach of deciding and using services as they see necessary.~     New and existing users of HIV/AIDS services in Wellington-Dufferin, Waterloo and Grey-Bruce~     Regions who consent to this study will be randomized to receive their usual self-directed~     supportive, educational, medical and medical care services when they seek assistance~     according to their needs or these usual services augmented by case management services. They~     will be measured before randomization and at 3, 6 and 12 months following service use for~     their satisfaction with HIV/AIDS services, compliance with HIV/AIDS medication, improvement~     in quality of life, psychological distress, risk behaviours and expenditures for the use of a~     range of publicly funded services.~   "
249973|NCT00280436|"~     This study is designed to find the optimal (best) doses of GW679769 that promote sleep onset~     and maintain sleep during two consecutive nights of dosing without significant next-day~     thinking impairment and drowsiness in subjects with primary insomnia.~   "
249974|NCT00280423|"~     This study is designed to find the optimal (best) doses of GW679769 that could be given daily~     to promote sleep onset and maintain sleep during the night without significant next-day~     thinking impairment and drowsiness in subjects with primary insomnia.~   "
249975|NCT00280410|"~     This is a multicenter, randomized, open-label study to investigate the superiority of the~     contrast enhancement effect of E7337 on tumor-like lesions in the Dynamic CT of the liver.~   "
249976|NCT00280397|"~     The purpose of this study is to determine the maximum tolerable dose (MTD) and the related~     effects of E7080 administered to patients with solid tumors that are resistant to approved~     existing anti-tumor therapies, or for which no appropriate treatment is available.~   "
249977|NCT00280384|"~     To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian~     healthy adult male subjects by comparing electrophysiological reactions after administering~     E2014 to extensor digitorum brevis muscle (EDB).~   "
249978|NCT00280371|"~     The purpose of this study is to determine the safety and efficacy of the investigational drug~     in comparison with a placebo.~   "
249979|NCT00280358|"~     The purpose of the study is to obtain initial pharmacokinetic data in healthy patients after~     dosing a combination of the study medications.~   "
249980|NCT00280345|"~     Based on these recent observations and findings in this new animal model of pigmentary~     glaucoma in the DBA/2J mouse, we propose that immune system abnormalities in the anterior~     chamber may play a possible role in the development of pigmentary glaucoma and possibly~     primary open-angle glaucoma (POAG) in humans.~   "
249981|NCT00280332|"~     -  To determine the prevalence of colonic neoplasm in patients who had previously undergone~          screening colonoscopy~        -  To determine the optimal time interval for re-screening in average risk individuals~        -  To determine potential baseline characteristics that predicts adenoma recurrence~   "
249982|NCT00280319|"~     That interpersonal psychotherapy and creative play therapies can reduce symptoms of~     depression among adolescents with depressive-type illness in northern Uganda.~   "
249983|NCT00280306|"~     White matter fiber tracking may provide a novel tool to assess the integrity of injured motor~     tracts in the cervical spine. It provides information about fiber directions which is not~     given by conventional MRI. White matter fiber tracking in the brain is used at several~     institutions, including our own medical college, for presurgical planning of tumor excision.~     We believe that the technical and clinical experience gained for the brain can be applied to~     fiber tracking in the cervical spine as well.~   "
249984|NCT00280293|"~     The purpose of this study is to determine if lamotrigine add-on therapy is associated with~     decreased cocaine craving and improvement in depressive symptom severity than placebo in a~     group of outpatients with bipolar disorder and cocaine dependence. Additionally, this study~     is examining whether lamotrigine add-on therapy is associated with decreased cocaine use and~     the improvement of manic symptom severity than placebo in a group of outpatients with bipolar~     disorder and cocaine dependence.~   "
249985|NCT00280280|"~     The purposes of this pilot study are to evaluate the safety and efficacy of Botox® compared~     to the safety and efficacy of oral baclofen in reducing muscle tone-related disability~     resulting from neurological damage or a stable neurological disorder and to evaluate~     drug-therapy tolerance.~   "
249986|NCT00280267|"~     The purpose of this study is to determine the feasibility of testosterone replacement therapy~     in frail elderly female hip fracture patients who have testosterone deficiency, and to obtain~     preliminary information about the effects of testosterone therapy on muscle strength and~     size, bone density, mobility, daily functioning, and quality of life.~   "
249987|NCT00280254|"~     The purpose of this study was to compare two strategies in the treatment of outpatients with~     heart failure. We hypothesized that an individualized treatment strategy based on the~     availability of hemodynamic data from non-invasive testing would be feasible and~     significantly reduce morbidity compared to the conventional clinically oriented treatment of~     heart failure outpatients.~   "
249988|NCT00280241|"~     This research study will look at the effects (good or bad) of administering cyclophosphamide,~     fludarabine, and rituximab. Clinical studies with combination therapy have shown higher~     response rates than using single drugs, and this study will evaluate the side effects and~     effectiveness of this combination.~   "
249989|NCT00280228|"~     This study will compare two programs to see if they are helpful in preventing the use of~     substances in adolescents with attention deficit-hyperactivity disorder (ADHD), oppositional~     defiant disorder (ODD), or conduct disorder (CD). One of the programs involves working with~     adolescents and their parent(s) in their home. The other program involves working with~     adolescents and their parent(s) in an office setting.~   "
249990|NCT00280215|"~     This study will test the effectiveness of two medications: ACEI (angiotensin converting~     enzyme inhibitor)and ARB (angiotensin receptor blocker) in reducing the renal injury induced~     by hyperoxaluria in patients with Primary Hyperoxaluria.~      Hypothesis: Calcium oxalate crystal deposition in the kidney causes inflammation and~     resulting injury to kidney tissue. Angiotensin blockade will improve these changes, thus~     slowing the progression of renal insufficiency in patients with Primary Hyperoxaluria.~   "
249991|NCT00280202|"~     The purpose of this research study is to determine the genetic changes and immunologic~     changes that are involved in the development and progression of lung cancer.~   "
249992|NCT00280189|"~     The purpose of this study is to assess short and long term outcomes after radiofrequency~     ablation (RFA) of pulmonary malignancies in patients who are not candidates for surgical~     resection. This study will evaluate the efficacy of RFA for the treatment of lung tumors by~     assessing its impact on local tumor control, progression free survival, overall survival,~     dyspnea score and quality of life (QOL).~   "
249993|NCT00280176|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as fluorouracil, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving bortezomib and fluorouracil together with radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with fluorouracil and external-beam radiation therapy in treating patients~     with stage II, stage III, or stage IV rectal cancer.~   "
249994|NCT00280163|"~     This research study is done to find out if genetic make up of a person plays a role in~     complications and recovery after the Coronary Artery Bypass Graft (CABG) operation.~      As you may be aware, the DNA (Deoxyribonucleic acid) is a chemical in our body that carries~     the genetic information. There are common but very small variations (polymorphisms) that~     occur in DNA. We would like to find out if these common variations put a person at increased~     risk for developing complications- especially rapid irregular heart beat after the CABG~     operation.~   "
249995|NCT00280150|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy~     uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together~     with bevacizumab, radiation therapy, and erlotinib may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of bevacizumab and~     erlotinib when given together with combination chemotherapy and radiation therapy and to see~     how well they work in treating patients with stage III non-small cell lung cancer.~   "
249996|NCT00280137|"~     To examine the psychometric properties of a brief quality of life (QOL) instrument for use in~     pediatric systemic lupus erythematosus (SLE). The purpose of this prospective study is~     primarily to determine the validity and reliability of a new health-related quality of life~     (HRQOL) measure in children with systemic lupus erythematous (SLE). We wish to secondarily~     examine concordance between child- and parent-reports of the HRQOL measure and identify~     factors associated with poorer HRQOL in them.~      Earlier studies have shown that SLE significantly impacts QOL in adults. At present, there is~     no disease-specific instrument for measuring HRQOL in children with SLE. In response to these~     concerns, we developed the Simple Measure of Impact of Lupus Erythematosus in Youngsters©~     (SMILEY©). Establishing the validity and reliability of SMILEY©, examining child-parent~     agreement and identifying factors associated with poorer HRQOL will enable us to measure the~     impact of SLE in children, and formulate appropriate interventions for this sensitive~     population. We plan the following specific aims:~        1. to determine construct validity and reliability of SMILEY© child and parent versions in~          children with SLE using gold standards (Pediatric Quality of Life inventory - PedsQL~          generic and rheumatology modules, Childhood Health Assessment Questionnaire -CHAQ)~        2. to determine responsiveness of SMILEY©~        3. to examine level of agreement between child- and parent-reports of SMILEY© in children~          with SLE~        4. to identify medical (steroid use, use of disease modifying agents such as cytoxan,~          cellcept, thalidomide, or cyclosporine, disease duration, disease activity and disease~          damage etc.) and psychosocial (self-concept, socioeconomic status) factors that affect~          HRQOL (as measured by child- and parent-reports of SMILEY© and PedsQL generic and~          rheumatology modules) and physical function 5) to translate, adapt and validate SMILEY~          in different languages~   "
249997|NCT00280111|"~     It has been observed that in children who get a severe rotavirus infection, subsequent~     infections cause either no symptoms or generally only mild or moderate diarrhea. This~     evidence is the basis for developing a vaccine since it suggests that the first infection~     immunizes the child against disease upon re-infection.~      It was found that neonatal avirulent strains 116E and I321 induce protective immunity and~     offer clinical protection for at least one year. Both these strains are well characterized~     and the safety studies have been done in animal models. These candidate vaccine strains have~     been evaluated for safety and immunogenicity in adults and children (2 to 12 years of age) by~     a randomized double blind placebo controlled trial in Cincinnati, USA. In India, the~     diversity of rotavirus strains is greater and there is greater prevalence of malnutrition and~     co-infection with other enteric pathogens. These vaccines have therefore, also been tested in~     India.~   "
249998|NCT00280098|"~     Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone~     refractory prostate cancer under the conditions of daily practise.~   "
249999|NCT00280085|"~     Assess pancreatic beta cell function using MR imaging.~   "
250000|NCT00280072|"~     -  The purpose of this study is to evaluate the safety and efficacy of the RAD to determine~          whether the RAD is effective in reducing mortality in patients with Acute Renal Failure~          due to Acute Tubule Necrosis and to evaluate the safety of the RAD~        -  If the RAD works normally when used for as long as 72 hours~        -  If the RAD will provide added benefits to normal CVVH therapy for patients with Acute~          Renal Failure~   "
250001|NCT00280059|"~     The purpose of this study is to assess whether Lyrica is a safe and effective treatment for~     partial epilepsy in comparison with an established treatment, Lamictal.~   "
250002|NCT00280046|"~     This trial was conducted in Russian Federation. This trial aimed for a comparison of the~     effect on glycemic control in subjects with type 2 diabetes of three different treatment~     regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in~     combination with metformin and treatment with oral anti-diabetic drugs.~   "
250003|NCT00280033|"~     This study is will gather critical information on the safety, tolerability, and the~     immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine~     in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject~     will participate for about 7 months and will be randomly placed in one of several different~     study groups receiving a different dose of vaccine or placebo. All subjects will receive two~     injections of their assigned study product, about 28 days apart, in the muscle. Subjects will~     keep a journal of their temperature and any adverse effects between study visits. A small~     amount of blood will also be drawn before the first injection, 7 days after each injection, 1~     month after the first injection, and 1 and 6 months after the second injection.~   "
250004|NCT00280020|"~     The purpose of this study is to evaluate whether Tai Chi Chih vs. cognitive behavioral~     therapy vs. sleep education reduces insomnia in older adults. The secondary goal of the study~     is to determine whether the behavioral treatment of insomnia alters proinflammatory cytokine~     activity.~   "
250005|NCT00280007|"~     Patients with liver cirrhosis and hepatocellular carcinoma will undergo transarterial~     chemoembolisation (TACE) as clinically indicated and will be randomized to receive~     bevacizumab or placebo every 2 weeks up to 1 year. Tumor response will be assessed using MR~     of the liver and PET-scanning.~      It will be tested whether the addition of bevacizumab as angiogenic inhibitor will slow down~     tumor progression, reduce the need for re-embolisation and will improve patient survival.~   "
250006|NCT00279994|"~     The purpose of this study is to determine if supervised exercise therapy in a~     physiotherapeutic setting, with or without therapy feedback, is more (cost-)effective than~     exercise therapy based on a 'go home and walk' advice without supervision, for patients with~     PAD stage II (Fontaine).~   "
250007|NCT00279981|"~     The purpose of this study is to look at the heart rate and rhythm information collected daily~     in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators~     (ICD) and cardiac resynchronization therapy (CRT) devices. The study will gather this~     information from many patients to see if heart rate or rhythm data can predict the risk of a~     patient having a medical condition such as stroke.~   "
250008|NCT00279968|"~     The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator~     (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias~     in order to better understand how to improve the clinical care of patients and effectiveness~     of ICD therapies.~   "
250009|NCT00279955|"~     The purpose of this study is to determine the value of diagnostic data obtained from~     Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization~     therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health~     care utilization.~   "
250010|NCT00279942|"~     Fibromyalgia is characterized by widespread pain that can lead to significant patient~     dysfunction and economic burden to society. The management of patients with fibromyalgia is~     difficult and no single treatment modality has been successful. We propose to study the~     effect of dietary soy supplement on quality of life associated with fibromyalgia.~   "
250011|NCT00279929|"~     The role of dehydroepiandosterone (DHEA) and its sulphated ester (DHEAS) [together known as~     DHEA(S)] in humans remains to be fully elucidated. They are the most abundant circulating~     steroid hormones in humans with the principle source of production being the adrenal glands.~     In adrenalectomised or hypoadrenal subjects it is not standard clinical practice to replace~     this hormone. Whilst this lack of DHEA(S) is clearly not life threatening, the published~     literature on the psychological effects of replacement in this population has shown some~     benefit in quality of life but data concerning the metabolic effects is conflicting and~     incomplete. We wish to carry out a study to measure the effect of DHEA(S) replacement in a~     group of adrenalectomised / hypoadrenal subjects and measure the outcome of a number of~     psychological and metabolic parameters both prior to and after twelve weeks of 50 mg/day~     DHEA(S) in a double blind randomised cross over design.~      Mood, quality of life and sexual well being will be assessed using validated questionnaires.~     In addition, we will utilise the GCRC facility to measure body composition using total body~     water and DEXA. We will measure insulin sensitivity, exercise performance, muscle~     fatigability and VO2 max. Pre- and post- intervention muscle biopsies will assess DHEA(S)~     effects on myosin heavy chain isoform expression; skeletal muscle mitochondrial ATP~     production and be used to assess muscle enzyme levels.~   "
250012|NCT00279916|"~     We hypothesize that intranasal steroid application will have a beneficial therapeutic effect~     in adults with regard to resolution of serous otitis media and/or negative middle ear~     pressure, as compared to placebo. We further hypothesize that the rate of spontaneous~     short-term resolution of otitis media wit effusion in adults treated with placebo will be~     relatively low (minority of patients).~   "
250013|NCT00279903|"~     Patients with painful knee osteoarthritis will be randomly allocated to one of three groups.~     Each group will receive a knee injection of: 1) cortisone, 2) low dose Botox, or 3) high dose~     Botox. Patients will then be followed for 6 months to see if they have significant pain~     relief or improvement in their activity level after the injection.~   "
250014|NCT00279890|"~     SR-01 may reduce facial redness. it is a topically applied product. The agent will be applied~     to local skin areas of subjects with red facial skin to assess affect, and then applied to~     the whole face to assess efficacy and safety~   "
250015|NCT00279877|"~     Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty~     for the treatment of painful, osteoporotic vertebral compression fractures.~   "
250052|NCT00279383|"~     OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register~     settled in Italy with the purpose of collecting data on 800 patients intra-operatively~     treated with hemostatic supporting agents/techniques in addition to the standard surgical~     procedures in 40 surgical wards. The availability of these data will allow for a better~     understanding of the therapeutic needs in the area of hemostatic supporting~     agents/techniques.~   "
250053|NCT00279370|"~     This study will determine the safety of antidepressant use during pregnancy for both the~     mother and the child.~   "
250016|NCT00279864|"~     Prosthetic joint infection is a devastating complication of total joint arthroplasty~     ultimately leading to the failure of the total joint arthroplasty function and possibly~     death. Optimal treatment requires the resection of the infected total joint arthroplasty~     followed by prolonged parenteral antimicrobial therapy. This procedure is followed by~     reimplantation of a new total joint arthroplasty at a later date. Surgical debridement and~     retention of the infected total joint arthroplasty offers a more conservative surgical~     approach and has been proven to be cost-effective in selected groups of patients. Traditional~     medical therapy for staphylococcal infection would require an initial parenteral~     antimicrobial followed by chronic oral non-rifampin containing antimicrobial suppression~     regimen for the life of the total joint arthroplasty. With this strategy the success rate is~     close to 30%. Recently, several prospective studies of patients with THA, TKA and fracture~     fixation device infections conducted in Europe showed that the success rate with a 3-6 month~     course of a quinolone-rifampin combination is effective in 70% to 100% of cases. The proposed~     study will be a prospective open label observational cohort that will evaluate the outcome of~     Patients with S. aureus PJI treated with a medical regimen that includes oral levofloxacin-~     rifampin and debridement and retention of components. This medical regimen was approved for~     use by the Orthopedic Infectious Diseases focus group, Mayo Clinic, Rochester. 15 patients~     will be enrolled over a one-year period and followed up to minimum of 1 additional year. The~     outcome of this group will be compared to a historical group that is treated with traditional~     therapy.~   "
250017|NCT00279851|"~     The purpose of this study is to determine if there is a significant percentage of children~     with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia~     (low blood sugar).~   "
250018|NCT00279838|"~     The purpose of this study is to determine whether intraoperative computer-assisted navigation~     improves prosthetic implant positioning as compared to conventional intraoperatve~     instrumentation in Total Knee Arthroplasty (TKA).~   "
250019|NCT00279825|"~     The objective of this study is to compare the pharmacokinetics and pharmacodynamics of~     IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa~     controlled-release tablets in subjects with idiopathic Parkinson's disease.~   "
250020|NCT00279812|"~     The aim of the study is to investigate the relationship between dose and form of selenium on~     immune function, and to identify functional markers of selenium status.~   "
250021|NCT00279799|"~     AFIYA aims to reduce both the risk of Sexually Transmitted Infections (STIs) and HIV in young~     African American females through a culturally and gender appropriate intervention (group~     sessions) coupled with an individualized HIV Telephone Maintenance Intervention.~   "
250022|NCT00279786|"~     Beta(2)-adrenergic receptor (BAR) agonists are the most important group of drugs used in the~     treatment of asthma. In children unresponsive to inhaled BAR agonist therapy, higher dose~     systemic BAR agonist therapy is frequently the next step in treatment. Despite the widespread~     use of intravenous BAR agonist therapy for pediatric status asthmaticus, there is controversy~     regarding the efficacy of this therapy. A number of studies have established that genetic~     variations of the BAR have important effects in modulating responses to BAR agonist therapy~     for asthma. In particular, changes in amino acid position 16 of the BAR gene are thought to~     be the most functionally important. Patients encoded for two glycine amino acids, rather than~     arginine, at this position appear to have more severe asthma and to respond differently to~     acute BAR agonist therapy.~      Our hypothesis is that genotypic differences may contribute to poor response to acute BAR~     agonist treatment. We propose to conduct a prospective observational study to determine the~     influence of a patient's BAR genotype on the response to acute BAR agonist therapy.~      Our specific hypothesis is that children with genetic polymorphisms of the gene encoding the~     BAR will have a decreased response to acute high-dose continuous BAR therapy (both inhaled~     and intravenous) compared to other children.~      Our primary outcome is ICU length of stay. Secondary outcomes are~        1. to assess the rate of improvement in clinical asthma score based on genotype, and~        2. to attempt to correlate asthma phenotype with genotype by comparing demographic data and~          hospital course.~   "
250023|NCT00279773|"~     The primary objective is to determine the maximum tolerated dose (MTD), dose limiting~     toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid~     leukemia (AML).~   "
250024|NCT00279760|"~     This randomized, double-blind, placebo controlled, parallel and multiple dose study provided~     safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and~     BMS-224818 in subjects with RA~   "
250025|NCT00279747|"~     A one year double-blind trial to investigate the efficacy and safety of meloxicam oral~     suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral~     suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.~   "
250026|NCT00279734|"~     Study to assess the ability of healthy subjects to build anitbodies to tetanus and~     pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is~     being developed for the treatment of Rheumatoid Arthritis and which can affect the immune~     system.~   "
250027|NCT00279721|"~     Resected well-differentiated thyroid neoplasms with at least one high risk feature will~     receive adjuvant radiation using IMRT with SIB. The acute toxicity and locoregional control~     rate at 2 years will be recorded.~   "
250040|NCT00279552|"~     Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal~     products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage.~     Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the~     diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test~     called Shilling’s test has been used for evaluation of the vitamin B12 absorption. However,~     the Schilling’s test is no longer easy accessible because of increasing difficulties to~     obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for~     Schilling’s test II (absorption of vitamin B12 attached to intrinsic factor) is no longer~     available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12~     has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to~     examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin~     B12 in patients with evident vitamin B12 deficiency.~   "
250028|NCT00279708|"~     This study will determine if atorvastatin (Lipitor) can help patients with pulmonary (lung)~     sarcoidosis and replace or reduce the need for patients to take steroids, such as prednisone.~     Sarcoidosis is an inflammatory disease that can affect nearly any part of the body. Pulmonary~     sarcoidosis may resolve on its own or it may progress to irreversible lung damage,~     disability, and death. Many sarcoidosis patients are treated with prednisone, but the drug is~     not effective in all patients, and it can cause serious side effects, such as high blood~     pressure, sugar diabetes, eye cataracts, and bone thinning.~      Patients with stage II or III pulmonary sarcoidosis between 18 and 70 years of age who~     require prednisone may be eligible for this study. Candidates are screened with the tests and~     procedures described below.~      Participants are randomly assigned to one of two treatment groups: one group takes~     atorvastatin; the other takes a placebo (a look-alike pill that has no active ingredient to~     fight sarcoidosis). Both groups take the pills by mouth once a day for 12 months. When~     treatment begins, participants begin to have their prednisone dosage tapered (reduced). The~     tapering is done over 8 weeks until the dose is reduced by 90 percent. Patients are evaluated~     periodically to determine if the two groups differ in how long they can remain on the reduced~     dose of prednisone without having their symptoms recur, requiring an increase in the~     prednisone dose. A full battery of tests is done at the initial screening visit and at the~     26- and 52-week follow-up visits, requiring hospitalization for 3-5 days. Additional interim~     outpatient assessments are done at 6, 12, 18 and 36 weeks.~      The full battery of tests at the initial screening and the 26- and 52-week visits includes~     the following:~        -  Medical history, physical examination, blood and urine tests, assessment of disease~          severity and activity.~        -  Questionnaires.~        -  Chest x-ray (CXR) and computed tomography (CT) scan.~        -  Abdominal ultrasound.~        -  Six-minute walk test (6MWT)~        -  Exercise testing and blood gases~        -  Pulmonary function tests (PFT)~        -  Maximum incremental ventilatory performance test (MIVP)~        -  Exhaled nitric oxide and carbon monoxide (Exhaled NO and CO)~        -  Bronchoscopy and lavage~      Interim testing at 6, 12, 18 and 36 weeks includes PFT, MIVP, Exhaled NO and CO, CXR,~     questionnaire, blood tests, and 6MWT.~      Six months after completing the study, participants fill out a questionnaire.~   "
250029|NCT00279695|"~     The objective of this research program is to improve diagnosis and treatment monitoring of~     ophthalmic disease by improving diagnostic ultrasound techniques. The program explores the~     use of novel signal and imaging processing techniques towards this end.~   "
250030|NCT00279682|"~     The purpose of this study was to determine the effect of a primary care intervention on~     reducing suicidal ideation and depression in older patients.~   "
250031|NCT00279669|"~     Premature infants stand a risk of danger to the layer of the eye that creates sight that, if~     untreated, can cause severe vision problems, leading to blindness in some cases. This~     research study will use ultrasound to examine the eye for retinal changes of prematurity.~   "
250032|NCT00279656|"~     The purpose of this study is to evaluate the impact of a collaborative approach (geriatric~     care involving the collaboration with a clinical pharmacist) to optimize the prescription of~     medicines for elderly inpatients.~   "
250033|NCT00279643|"~     The purpose of this study is to learn more about how hair removal with lasers achieves, what~     appears to be, permanent hair reduction. Laser hair removal has become one of the most~     popular and commonly performed procedures in cosmetic dermatology. However, relatively little~     is known about how the permanent reduction in the treated areas occurs. Recently, it has been~     discovered that certain cells in the hair follicle must be destroyed in order to achieve~     permanent hair reduction. A marker of these types of cells known as keratin 15 has been~     identified. By measuring the amount of keratin 15 before and after laser therapy, we hope to~     gain a better understanding of how lasers cause hair reduction on a biochemical level.~   "
250034|NCT00279630|"~     Posterior tibial tendon dysfunction (PTTD) is the most common cause of painful and~     debilitating acquired flatfoot deformity in adults. The dysfunction is often progressive and~     may result in attenuation of the PTT and eventually collapse of the plantar arch or even~     rupture of the tendon. Current therapeutic management of PTTD is multipronged and includes~     management with foot orthoses, stretching, and strengthening exercises. Evidence drawn from~     research related to the management of painful chronic Achilles tendinosis suggests that~     eccentric strengthening of the posterior tibialis may lead to superior results compared to~     concentric. The purpose of this research is to determine the effectiveness of treatment~     interventions used in the management of PTTD.~   "
250035|NCT00279617|"~     The main purpose of this research study is to determine whether the drug Levetiracetam~     (Keppra™) is effective in the prevention of panic attacks. The drug Levetiracetam (Keppra™)~     has been approved for the treatment of seizures by the U.S. Federal Food and Drug~     Administration (FDA) and is available by prescription. Levetiracetam has not been approved by~     the FDA for the treatment of panic disorder.~   "
250036|NCT00279604|"~     INCA (Intervention and Neuropsychology of Cannabis Abuse) is a study combining two research~     goals. One is to study efficacy of a short intervention the ‘Problem Profile Intervention’,~     which utilizes individual feedback from a ‘substance problem check-up’. Subjects will~     randomly receive the ‘Problem Profile Intervention’ or the WHO Brief Intervention, a brief~     intervention, which has been shown to be efficacious. Currently efficiency studies are under~     way. The WHO Brief Intervention has been translated into German by our group. In contrast to~     most other cannabis intervention studies the current study is focussed on cannabis abusers~     not so much cannabis-dependent subjects. A total of 160 subjects are to be recruited. Half of~     them will randomly receive either the Problem Profile Intervention or the WHO Brief~     Intervention (active control). A total of 25% of subjects from each group will be placed on a~     3 months waiting list before receiving the intervention (inactive control). Intervention~     outcome will be assessed three months, six month and 12 months after the intervention. We~     hypothesize cannabis use to be reduced by 25% by the 'Problem Profile Intervention'. The~     second aim of the study is to study mechanism of substance abuse. Initial results from own~     studies and data from other groups point to executive cognitive functions as a subtle but~     important factor that can be compromised in cannabis users (Verdejo-Garcia et al., 2004;~     Garavan and Stout, 2005). Using an fMRI-study, we intend to examine a subgroup of our~     subjects on a specific aspect of executive functioning that has recently received major~     interest in drug research: Decision-making capability, or risk-taking behaviour, respectively~     (e.g. Ernst and Paulus, 2005).~   "
250037|NCT00279591|"~     A randomized controlled trial compared the clinical outcomes of transported pediatric~     patients monitored with an oscillometric blood pressure device versus those monitored with a~     near-continuous, noninvasive blood pressure.~   "
250038|NCT00279578|"~     In the present study we are examining the clot formation and clot stability in patients with~     severe haemophilia A after they receive recombinat factor VIII and after addition of~     tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability.~     The perpective of the study is to document whether it is relevant to use traneksamic acid in~     surgery in patients with severe haemophilia A.~   "
250041|NCT00279539|"~     The purpose of this study is to evaluate the safety and bioactivity of intramyocardial gene~     transfer using VEGF (vascular endothelial growth factor) in patients with ischemic heart~     failure. The research treatment of this CHF study will involve the use of an intramuscular~     injection with a catheter inserted in through the groin to transfer a type of DNA (phVEGF165~     gene) to the wall of the heart. Genes (which are part of the DNA molecules) carry~     instructions to allow the cells to produce specific proteins. Gene transfer or treatment with~     DNA (a necessary part of all cells) is being studied for the treatment of patients with heart~     failure. This research therapy, which is experimental and not proven, is designed to try to~     grow new blood vessels to improve blood flow to areas of the heart that are not receiving~     enough blood.~      DNA is present in all cells and provides the instructions for making proteins. After~     delivering a piece of DNA containing the vascular endothelial growth factor 1 (VEGF-1) gene~     (the product being studied) into cells, the cells may produce a specific protein called~     vascular endothelial growth factor 1 (VEGF-1). Animal studies have indicated that the VEGF-1~     protein may cause new blood vessels to grow. The Vascular Endothelial Growth Factor Gene (ph~     VEGF 165) is found on the VEGF DNA. Experiments performed in animals show that once in the~     heart wall, the DNA directs the cells of the heart muscle to make the VEGF protein. VEGF 165~     is a protein that has been shown to stimulate cells (known as endothelial cells), which form~     the inner lining of blood vessels. This protein causes cells to divide and grow, thereby~     forming new blood vessels. It is anticipated that this new blood supply may help the heart~     pump the blood more effectively and relieve some heart failure symptoms. We do not yet have~     enough information to know what will happen in humans, that is why we are doing this~     research.~      After gene transfer we will begin a process to help move some of the stem cells from the bone~     marrow into the blood circulation. Subjects will be given the drug called G-CSF (a drug used~     to move cells from the bone marrow into the blood stream). Stem cells are young cells~     produced by bone marrow (the spongy cavity in the center of large bones) that can develop~     into blood cells or other types of cells. This medication triggers the movement of stem cells~     out of the bone marrow and into the blood stream. Before being released into the blood~     stream, stem cells receive signals that direct them to become specific types of cells such as~     CD34+ cells (endothelial progenitor cells). CD34+ cells that move to or are in the area of~     damaged heart tissue may promote growth of new blood vessels that supply blood and nutrients~     and thereby improve the chance of survival of heart tissue, improve heart function, and~     possibly have a long-term benefit.~      We will be recruiting 12 subjects for this study. There will be no randomization and no~     placebo group. Once eligibility in the research study has been determined all subjects will~     be treated with the VEGF and G-CSF.~   "
250042|NCT00279526|"~     The increase in life expectancy in the 21st century has resulted in a major growth in the~     prevalence of age-related diseases and conditions. Depression has been found to be the most~     prevalent among the various mental disorders in later life. It was emphasized that depression~     in the elderly is a persistent or recurrent disorder resulting from psychosocial stress or~     physiologic effects of disease and can lead to disability, cognitive impairments, intensified~     symptoms of other medical conditions and increased utilization of health care services. Due~     to the rapidly aging population, depression is a serious public health concern that has a~     great impact on quality of life and may lay a considerable burden on the health care systems.~     However depression among the elderly may prove to be hard to diagnose since in aged persons~     depressive symptoms are often masked by somatic complaints or by cognitive impairments.~     Consequently depression is often under diagnosed and the patients continue to visit~     constantly the nurse or the physician without getting an adequate answer to their problem.~     For that reason over utilization of health care services may be an indicator to the presence~     of undiagnosed depression. The purpose of this study is to examine the relationships between~     socio-demographic variables, high primary care utilization and depressive symptomatology~     among aged patients.~   "
250043|NCT00279513|"~     Hallux valgus is a common deformity of the big toe, defined as medial deflection of the first~     metatarsal bone along with lateral deflection of the first toe. Surgery has been shown to be~     beneficial when compared to orthoses or no treatment. While generally effective, surgery~     entails significant post-operative pain, inflammation and edema, and several weeks of limited~     mobility. This will be a double-blind, randomized, placebo-controlled study comparing the~     homeopathic drug Traumeel S with placebo in pain reduction after surgical Hallux valgus~     correction.~      80 patients, over the age of 18 years, undergoing surgical correction of unilateral hallux~     valgus will be enrolled in the trial. The patients will be randomized to two groups, one~     receiving oral Traumeel S and the other oral placebo tablets. Patients will take active or~     placebo medication for 13 days or until they have a NRS score of 3 or less for 2 consecutive~     days. Pain will be reported daily by the patient on the patient diary, using an 11-point~     numerical rating score (NRS-11) during 13 days post-operatively. They will also be asked to~     report daily consumption of primary and rescue analgesics for 13 days post-operatively.~     Patients will be contacted daily by the research assistant to encourage compliance and to~     record their daily NRS and analgesic consumption in the CRF. Patients will be evaluated by~     physicians at six and 13 days postoperatively for redness and compliance.~   "
250044|NCT00279500|"~     The objective of this study is to evaluate the safety and efficacy of the retinal stimulation~     system by evaluating the data after chronic implantation.~   "
250045|NCT00279487|"~     The purpose of this study is to determine whether gabapentin, as a one time administration~     prior to a total knee replacement procedure, has opioid sparing effects and a reduction in~     pain scores.~   "
250046|NCT00279474|"~     The aim of the study is to evaluate the effect of cognitive behavior group intervention with~     cancer patients and their family members. Around 80 cancer patients and their family members~     will participate in group intervention and will be compared with 80 controls.~   "
250047|NCT00279461|"~     Recent studies have demonstrated that subjects with low blood levels of vitamin D are at a~     higher risk of developing autoimmune diseases such as Rheumatoid Arthritis (RA). We are~     pursuing these studies to test the hypothesis that restoration of vitamin D levels~     ameliorates the manifestations of RA. We will test this hypothesis by inviting patients with~     RA to participate in a trial that examines the effects of oral vitamin D administration on~     the clinical expression of this disease. For this purpose, the participants of this trial~     will be asked to take an oral dose of 2,000 units of vitamin D daily for 6 months. We will~     examine the participant's joints, assess disease activity measures, and determine his/her~     blood levels of vitamin D before starting this treatment and periodically thereafter.~   "
250048|NCT00279448|"~     To compare recurrence free survival between two treatment groups (5 years with exemestane vs~     2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5~     years)~      This Pfizer sponsored trial is part of an international collaboration of investigators~     conducting 7 similar yet independent studies in 9 countries. This study is designed to be~     part of the larger TEAM trial where the data from these 7 studies will be combined. A~     pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial~     [971-ONC-0028-081/A5991026] Study Results:~     http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1~   "
250049|NCT00279435|"~     The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and~     immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior~     visilizumab study.~   "
250050|NCT00279422|"~     The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects~     with intravenous steroid-refractory ulcerative colitis.~   "
250054|NCT00279357|"~     Does a new colonoscopic viewing technique called narrow band imaging (NBI) help doctors~     detect more patients with at least one pre-cancerous polyp (adenoma) than conventional~     colonoscopy using white light alone?~      May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro~     allow assessment of inter- and intra-observer variability.~   "
250055|NCT00279344|"~     Primary objectives:~        -  To determine non-inferiority of FITpatch with regard to efficacy compared to standard~          opioid treatment~        -  To assess the safety of FITpatch compared to standard opioid treatment~      Secondary objectives:~        -  To assess the intake of oral morphine as rescue analgesic to FITpatch compared to~          standard opioid treatment~        -  To assess Quality of life reported with FITpatch compared to standard opioid treatment~   "
250056|NCT00279331|"~     The purpose of this observational study is to estimate the number of new HIV infections and~     the number and variability of antiretroviral-resistant HIV strains among men who have sex~     with men (MSM). Participants will be recruited from four sites in Peru and one site in~     Ecuador.~   "
250057|NCT00279318|"~     The long-term goal of the TEDDY study is the identification of infectious agents, dietary~     factors, or other environmental agents, including psychosocial factors which trigger T1DM in~     genetically susceptible individuals or which protect against the disease. Identification of~     such factors will lead to a better understanding of disease pathogenesis and result in new~     strategies to prevent, delay or reverse T1DM.~   "
250058|NCT00279305|"~     Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the~     insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot~     maintain proper blood glucose levels in response to daily activities such as eating or~     exercise. With fewer insulin producing cells blood glucose increases, causing hunger, thirst,~     and unexplained weight loss. By the time these symptoms develop, 80-90% of a person's beta~     cells have already been destroyed. However, this also means that between 10-20% of these~     cells remain that continue to produce insulin.~      Scientists have learned that two types of immune cells, B cells and T cells, are involved in~     causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells~     that make insulin. Although they don't attack insulin producing cells, B cells may be what~     trigger the T cells to attack.~      This study will investigate the use of rituximab to see if it can help lower the number of~     immune B cells thereby preventing the destruction of any remaining insulin producing beta~     cells that remain at diagnosis. Rituximab is approved by the Food and Drug Administration~     (FDA) for the treatment of a condition called B-lymphocyte lymphoma. Its effects on the~     immune system are well understood through its use in organ transplantation. Research has~     shown that rituximab might be helpful in treating other conditions caused by T cells and B~     cells, including type 1 diabetes. The goal of this study is to find out if rituximab can~     preserve residual insulin secretion and prevent further beta cell destruction in type 1~     diabetes.~   "
250059|NCT00279292|"~     This is a clinical trial to determine more effective methods of controlling the pain in~     pancreatic cancer. Although narcotic pain medication are effective, they have many side~     effects and are underutilized due to social stigma and fear of addiction. Celiac plexus~     neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled~     clinical trials. We hypothesized that celiac plexus neurolysis plus pain medication will be~     more effective and have fewer side effects than pain medication alone. We are evaluating the~     effectiveness of this standard pain medications with or without celiac plexus neurolysis in a~     randomized controlled trial. One half of the participants will receive pain medications only~     and the other half will receive pain medications plus neurolysis, delivered via an endoscopic~     ultrasound device placed in the stomach.~   "
250060|NCT00279279|"~     The purpose of this study is to test specific device programming in patients without a~     previous history of a life-threatening, abnormally fast heartbeat who are implanted with a~     Medtronic ICD (Implantable Cardioconverter Defibrillator) or ICD with CRT (Cardiac~     Resynchronozation Therapy) device. The information learned from this study could be used to~     guide physicians in future ICD or CRT device programming.~   "
250061|NCT00279266|"~     This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in~     patients with diabetic peripheral neuropathy.~   "
250062|NCT00279253|"~     Background Clonidine, a derivate of Imidazol, is an antihypertensive drug. It acts by~     stimulating adrenergic receptors on nerves in the brain and Imidazol-receptors. As a result,~     clonidine slows the heart rate and reduces blood pressure. Clonidine was approved by the FDA~     in 1974 and is registered in Austria with the brand name “Catapresan”.~      Alpha2 adrenergic agonists are nowadays used topically as eye drops in glaucoma treatment. In~     addition to their known effect of lowering intraocular pressure, alpha2 adrenoceptor agonists~     are neuroprotective. Brimonidine, which is the most commonly used topical alpha-2 agonist, is~     currently on the market for treatment of glaucoma and is effective in reducing intraocular~     pressure. It has, however, been shown that brimonidine is a very potent vasoconstrictor in~     the ciliary body thus reducing aqueous humor production. Little is, however, known about~     potential vasoconstrictor effects of brimonidine in the posterior pole of the eye. This is of~     clinical importance, because optic nerve head ischemia appears to contribute to glaucoma~     pathophysiology. Direct investigation of the ocular hemodynamic effects of brimonidine is,~     however, difficult, because lowering intraocular pressure with brimonidine may confound the~     results due to the concomitant change in ocular perfusion pressure.~      The aim of the present study is to assess the effect of intravenous clonidine as model drug~     of alpha agonists on ocular blood flow and IOP in healthy humans.~      Study objectives:~      To investigate effects of clonidine on ocular blood flow and intraocular pressure.~   "
250063|NCT00279240|"~     Three year prospective randomised controlled trial in IGT subjects to study the effect of~     metformin and lifestyle modification in preventing the conversion to diabetes~   "
250140|NCT00278187|"~     RATIONALE: Monoclonal antibodies, such as volociximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Volociximab may also stop the~     growth of non-small cell lung cancer by blocking blood flow to the tumor. Erlotinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     volociximab together with erlotinib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving volociximab together with erlotinib~     works in treating patients with stage III or stage IV non-small cell lung cancer.~   "
250064|NCT00279227|"~     We sight to evaluate whether patients with coronary artery disease (CAD) have more epicardial~     fat than patients without CAD, which would suggest that epicardial fat may be more than an~     “innocent bystander” and be actively involved in the disease process. Its role as a modulator~     of vascular response and myocardial function could potentially lead to new areas of cardiac~     research. We also sight to evaluate whether epicardial fat from patients with CAD releases~     more adipokines than subcutaneous fat from these patients which could prompt studies into the~     differential regulation of adipokine secretion in this tissue. Thus for e.g., the use of~     thiazolidinediones (glitazones), statins, ARBs or other compounds that can specifically~     modulate adipokine secretion could be explored to determine their benefit in ameliorating the~     effects attributable to increased epicardial fat.~   "
250065|NCT00279214|"~     The study will evaluate the vasopressor requirement, hemodynamic response and measures of~     tissue perfusion in patients with septic shock receiving an infusion of drotrecogin alfa~     (activated) compared to patients not receiving drotrecogin alfa (activated).~   "
250066|NCT00279201|"~     This study will compare insulin lispro low mixture [LM] and insulin glargine both in~     combination with the patient's oral diabetes medicines, for their ability to control blood~     sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with~     regard to the length of time that the overall blood sugar can be controlled.~      This study will also determine whether the safety of insulin lispro LM and any side effects~     that might be associated with it are different from those observed with insulin glargine,~     both in combination with the patient's oral diabetes medications.~      The addendum study (Intensification Addendum) will compare how different insulin treatments~     work to control blood sugar in patients whose diabetes could not be controlled by either~     insulin lispro LM or insulin glargine.~   "
250067|NCT00279188|"~     The long-term course of asthma shows variable outcome with regard to the incidence of~     exacerbations and the decline of lung function over time. The present study aimed:~        1. to investigate whether asthma management additionally guided by the degree of bronchial~          hyperresponsiveness leads to a better outcome~        2. to examine the predictors among clinical and inflammatory disease markers of the~          long-term decline in lung function~   "
250068|NCT00279175|"~     Impaired contractile function after a heart attack of the heart is a major cause of heart~     failure limiting quality of life and prognosis, which cannot be prevented even with optimal~     standard therapy, including immediate balloon/stent dilation of the infarct vessel.~      The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into~     the infarct vessel (after successful reperfusion therapy) may improve left ventricular~     contractile function compared to placebo therapy. After bone marrow aspiration progenitor~     cells are enriched via a centrifugation method.~   "
250069|NCT00279162|"~     Patients will receive either a gel containing both calcipotriene plus betamethasone or gel~     with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this~     time all patients will receive the gel containing both calcipotriene and betamethasone for 44~     weeks. In addition, patients will receive an ointment containing both calcipotriene plus~     betamethasone as treatment for their psoriasis of the trunk and limbs for 52 weeks.~      The objective is to study the short-term efficacy of the gel, and the short and long-term~     safety of the gel and the ointment.~   "
250070|NCT00279149|"~     The objective is to evaluate decision making of i.v. tPA treatment in acute stroke within 3~     hours of symptom onset either remotely via videoconferencing system (investigational arm)~     beginning of treatment on-site and then transfer to stroke unit vs. decision after immediate~     transfer to stroke unit (usual care arm). Ten remote hospitals are connected to the BICHAT~     stroke unit. All patients will have stroke unit care at BICHAT hospital. Primary end-point is~     rankin 0-1 at 3 months.~   "
250071|NCT00279136|"~     Asthma and COPD are characterized by airway narrowing. The most potent, physiological~     mechanism leading to bronchodilation is taking a deep inspiration. This protects healthy~     subjects against bronchoconstrictive stimuli, and reverses pre-existing bronchoconstriction.~     However, the deep breath-induced bronchoprotection and -bronchodilation is impaired in~     asthma. We questioned whether this is specific for asthma (in comparison to COPD), and~     whether this is associated with bronchial inflammation and -remodelling. The study is a~     two-groups comparison, of physiological and pathological disease markers, obtained by~     methacholine challenges, monitoring airways resistance, and by taking bronchial biopsies.~   "
250072|NCT00279123|"~     Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant~     medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on~     potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in~     preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole~     decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.~      There is little data regarding the effect of pantoprazole on bleeding peptic ulcers.~     Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of~     gastric pH in addition to clinical outcome.~      This study compares the effect of two doses of intravenous pantoprazole with no acid~     suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual~     clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the~     clinical outcome.~   "
250073|NCT00279110|"~     The purpose of this study is to determine whether providing directly administered~     antiretroviral therapy to HIV-infected who receive methadone therapy leads to better~     treatment outcomes than if they take HIV medications on their own.~   "
250074|NCT00279097|"~     The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or~     immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™~     in neurosurgical subjects.~   "
250075|NCT00279084|"~     In type 2 diabetics, progression from chronic kidney disease to end stage renal disease may~     be slowed down by therapeutic interventions as angiotensin converting enzyme inhibitors use,~     control of high blood pressure and proteinuria, control of hyperglycaemia, protein intake~     restriction, smoking cessation.~      Correcting anaemia in these patients may prevent impairment of renal function. International~     guidelines indicate that haemoglobin level has to be of 110 g/L in these patients. We conduct~     an interventional randomized trial to evaluate the potential benefit of an haemoglobin level~     of 130 g/L in patients with type 2 diabetes and with a chronic kidney disease defined by a~     Cockcroft's creatinine clearance of 25 - 60 ml/min.~   "
250076|NCT00279071|"~     Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary~     inertia.~      A randomized controlled trial including 150 pregnant women Acupuncture has become a natural~     part of the range of obstetric treatments offered in danish delivery wards, but there is only~     little evidence to the effect of the acupuncture.~      The women are randomized into to groups.~        1. Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)~        2. No treatment~      The women will be asked in case beginning signs of inertia, if they want to parcipitate in~     the trial.~      Inclusion criteria:~        1. Normal pregnancy~        2. In labour (orificium < 8 cm), 37th week or thereafter~        3. Ruptured membranes~        4. Primary or secondary inertia~      The women will just before randomization be vaginally explored and fetal heart monitored. The~     meassure of effect happens two hours after randomization.~      The midwife who measures the effect, is blinded to the treatment or lack of, and also on the~     including exploration.~      Secondary effect meassures: length of labour, use of oxytocin and number of contracions~     pr/min meassured twice:~      1. before the randomization and again 1 hour after randomization.~   "
250077|NCT00279058|"~     Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized,~     this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy~     represents an approach to treatment based on the immune response to cancer antigens.~      The principal objective of the study is to identify whether a dendritic cell-based vaccine~     can increase the moderate therapeutic effect of bolus high dose IL-2 in patients with~     metastatic melanoma. For this purpose,patients with metastatic melanoma who have a certain~     blood type (HLA-A201+) will be treated systemically with high dose IL-2. In one group of~     patients, the IL-2 will be preceded by three doses of autologous dendritic cell pulsed with~     melanoma antigens appropriate for their blood type. Two cycles of three DC vaccines will be~     administered every 14 days by intra-lymph node injections, followed by high dose IL-2~     treatment. Responding patients will receive additional DC vaccines at 1 month and 2 months~     intervals.~      In a second group, patients will receive the standard high dose IL-2 protocol within a~     comparable period of time.~      Each group will include 12 patients.~      A complete evaluation of evaluable lesions will be performed prior to accrual, after initial~     3 DC vaccines, six weeks after first IL-2 treatment, after a total of 6 DC vaccines and 6~     weeks after second cycle of IL-2 treatment.~   "
250078|NCT00279045|"~     The study will compare and evaluate the effects of long-term treatment of monotherapy with~     rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of~     glycemic control in patients with recently diagnosed type 2 diabetes mellitus.~   "
250079|NCT00279032|"~     The findings from preclinical animal models confirm the peripheral~     anti-inflammatory/analgesic activity of GW406381 and also suggest contribution of a central~     site of action to the anti-hyperalgesic efficacy that may not be shared by other COX-2~     inhibitors. A central action is consistent with distribution of GW406381 into the CNS in~     animals. Furthermore, preliminary data from a positron emission tomography study in which 6~     healthy male volunteers received a tracer dose of 11C labelled GW406381 indicate that~     GW406381 is rapidly absorbed into the central nervous system in man.~   "
250080|NCT00279019|"~     GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being~     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long~     duration of action of GSK233705 when administered via inhalation in animal models supports~     the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary~     disease.~      GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being~     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long~     duration of action of GSK233705 when administered via inhalation in animal models supports~     the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary~     disease.~   "
250081|NCT00279006|"~     This study will evaluate the 3 drug-eluting stents presently marketed for intervention in the~     coronary artery with respect to the complications that may occur in case it becomes necessary~     to retract the stent during the intervention. It has been noted that stents carrying a drug~     for local application may be more difficult to retract than the more smooth bare metal~     stents.~   "
250082|NCT00278993|"~     This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients~     with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic~     disease and who have had prior anti-androgen therapy. The study will further explore the~     efficacy of E7389 by enrollment of patients into two strata: those who have had no prior~     systemic chemotherapy for their disease (except for mitoxantrone and estramustine), and those~     who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents~     such as docetaxel.~   "
250083|NCT00278980|"~     The aim of the study is to investigate the effect of C-peptide administration on nerve~     function in patients with type 1 diabetes and peripheral sensory neuropathy.~   "
250084|NCT00278967|"~     To compare the safety and efficacy of 2 different bowel cleansing preparations prior to~     colonoscopy in adult subjects.~   "
250085|NCT00278954|"~     The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food~     and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial~     infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The~     secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine~     if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin~     G (IgG) in subjects with PID.~   "
250086|NCT00278941|"~     The purpose of this study is to determine safety & efficacy of SEROQUEL SR™ in the treatment~     of major depressive disorder compared to placebo & to evaluate quality of sleep, overall~     quality of life, and effect, if any, on anxiety and satisfaction PLEASE NOTE: Seroquel SR and~     Seroquel XR refer to the same formulation. The SR designation was changed to XR after~     consultation with FDA.~   "
250141|NCT00278174|"~     RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth~     of kidney cancer.~      PURPOSE: This phase II trial is studying how well interferon alfa works in treating patients~     with metastatic kidney cancer.~   "
250215|NCT00277160|"~     The purpose of this study is to assess pegfilgrastim starting with the first cycle versus~     secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays,~     dose reductions, and hospitalizations) in older patients receiving chemotherapy.~   "
250087|NCT00278928|"~     This will be a prospective, randomized trial to determine if differences exist in the~     tolerance of lipid injectable emulsions in the neonatal intensive care unit (NICU). Lipid~     injectable emulsions are an essential nutrient for neonatal growth and development.~     Traditionally, lipid injectable emulsions have been commercially available in sterile glass~     bottles, but in April of 2004, a new container was introduced as a sterile plastic bag. In~     January, 2005, NICU personnel observed what appeared to be a higher than usual incidence of~     hypertriglyceridemia. Upon further laboratory investigation of the lipid injectable emulsions~     stored in glass bottles versus those in plastic, significant differences were noted in the~     population of large-diameter fat globules by globule size analysis, reflective of a less~     stable emulsion in plastic. The United States Pharmacopeia (USP) which sets the standards for~     drug purity and safety in the U.S., and whose drug monographs are enforceable by the FDA, has~     proposed to limit this large diameter fat globule population to a volume-weighted percent fat~     greater than five micrometers or PFAT5 to be less than 0.05% of the total lipid~     concentration. (At the present time, the USP monograph is not officially recognized, but is~     on track for adoption in 2006.) Our preliminary analyses of four lots of 20% lipid injectable~     emulsion packaged in glass to have a PFAT5 of 0.003±0.0008%, compared to an approximate~     55-fold increase in the large-diameter fat globule population or 0.166±0.016% for an equal~     number of products packaged in plastic. We hypothesize this difference may explain the recent~     clinical observations. We will compare the incidence of hypertriglyceridemia in neonates~     between lipids packaged in glass versus those in plastic. The study will attempt to discern~     whether the differences in packaging influence the stability and subsequent tolerance of~     lipid injectable emulsions.~   "
250088|NCT00278915|"~     The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a~     study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty~     (early puberty) in girls with McCune-Albright syndrome (MAS).~   "
250089|NCT00278902|"~     This is a Phase 1 study during which patients with advanced solid tumors will receive~     investigational study drug ARRY-334543.~      This study has 2 parts. In the first part, patients will receive increasing doses of study~     drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible~     that will not cause unacceptable side effects. Approximately 70 patients from the US and~     Canada will be enrolled in Part 1 (Completed).~      In the second part of the study, patients will receive the best dose(s) and schedule(s) of~     study drug determined from the first part of the study and will be followed to see what side~     effects the study drug causes and what effectiveness it has, if any, in treating the cancer.~     Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).~   "
250090|NCT00278889|"~     The primary purpose of this study is to compare the efficacy of AZD2171 in combination with~     FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line~     treatment of patients with metastatic colorectal cancer~   "
250091|NCT00278876|"~     The presence of c-kit mutation is an independent poor prognostic factor for relapse in~     addition to large size (> 5 cm) and high mitotic rate (> 5/50 high power field [HPF]) in~     localized gastrointestinal stromal tumor (GIST) patients who underwent complete surgical~     resection. In addition, the localized GIST which had exon 11 c-kit mutation and features of~     high-risk for relapse according to National Institute of Health (NIH) consensus guideline~     (tumor size > 10 cm or mitotic count > 10/50 HPF) also have high-risk of relapse. Until~     recently, there has been no effective therapy for advanced, unresectable GISTs. However, a~     new agent, imatinib mesylate, has shown promise in the metastatic setting, and c-kit exon 11~     mutation is the strongest prognostic factor for better response and survival. It is~     reasonable to try imatinib in an earlier and minimal residual status especially for patients~     at higher risk of relapse and a higher probability of response to imatinib.~   "
250092|NCT00278863|"~     A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of~     age and older. In addition, patient delay in seeking care for symptoms results in diagnosis~     at a more advanced stage than that seen in younger individuals. However, clinical trials on~     gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which~     have been reported to have clinically significant response rates and survival with mild or~     negligible toxicities, have been widely used for the patients with AGC. However, few studies~     have been conducted in elderly patients.~   "
250093|NCT00278850|"~     The purpose of this study is to investigate the efficacy of an educational seminar series for~     women with vulvar vestibulitis syndrome (VVS).~   "
250094|NCT00278837|"~     Women with breast cancer often suffer significant distress and disability from their disease.~     A practice of meditation-based stress reduction and cognitive-affective-behavioral learning~     may help women with breast cancer decrease their suffering and improve their quality of life.~   "
250095|NCT00278824|"~     A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug~     Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the~     treatment of breakthrough pain in adult patients with moderate to severe non-malignant~     chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will~     last up to 15 days. Eligible patients who complete the open-label arm will be allowed to~     enroll in the double-blind study arm.~   "
250096|NCT00278811|"~     The purpose of this study is to compare two different kinds of follow-up care and their~     effects on psychiatric service use and psychological well-being. This randomized, controlled~     trial of subjects discharged from the psychiatric emergency services to outpatient care~     receive traditional hospital-based outpatient clinic referrals (treatment as usual) or~     appointments for community-based follow-up by a mobile crisis team.~   "
250097|NCT00278798|"~     The objective of this study is to compare radical hysterectomy with trachelectomy on outcomes~     related to intimacy, sexual health, and mood immediately before, 1 month after, and 6 months~     after surgery.~   "
250098|NCT00278785|"~     The underlying hypothesis that providing brief interventions to individuals who engage in~     potentially harmful patterns of alcohol use will alter their drinking behavior and therefore~     avoid negative consequences. Specifically, this study aims to determine if brief~     interventions will:~        1. Reduce the number of re-admissions and deaths due to injuries associated with alcohol~          consumption~        2. Reduce the number of driving under the influence (DUI) arrests~        3. Reduce harmful drinking behavior~   "
250099|NCT00278772|"~     The purpose of this research study is to evaluate the safety, tolerability, and efficacy of~     divalproex extended release compared to placebo (sugar pill without medication) in the~     treatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproex~     extended release is approved by the United States Food and Drug Administration (FDA) for the~     treatment of epilepsy and for prevention of migraine headaches.~   "
250321|NCT00275678|"~     This study will compare the outcomes of study participants who have had peripheral blood stem~     cell transplantation or with those who have had bone marrow transplantation from an unrelated~     donor for the treatment of serious hematological malignancies.~   "
250100|NCT00278759|"~     Acute respiratory tract infections are among the most common problems of childhood,~     particularly among infants and children younger than 3 years, and account for most antibiotic~     prescriptions to children. Most of these infections are self-limited and do not require~     medical intervention; however, the symptoms overlap significantly with those of severe viral~     or bacterial infections. At the hospital Emergency Department (ED), medical assessment,~     prescription of antibiotics (unnecessarily if the infection is viral), and a series of~     investigations (e.g., blood work, X-rays) often take place before a decision on patient~     management and possible hospital admission can be made. Such procedures lead to intense use~     of human health resources (nursing, laboratory and radiology staff) and hospital facilities.~      The literature suggests that a prompt single viral diagnosis improves decision-making. To our~     knowledge, no-one has performed a controlled trial to examine the impact of a rapid,~     multi-viral detection test like VIRAP, or the impact of the timing of such a test, on~     management of children with flu-like illnesses in the ED.~      Our objective is to determine if use of our new viral detection program, VIRAP, for rapid~     testing for viral respiratory infections right after triage will improve patient management~     and resource use in the ED. We will test the hypothesis that availability of VIRAP at triage~     to support rapid diagnosis of viral infection in children at BCCH will (i) reduce the waiting~     time in the ED; (ii) improve decision making regarding diagnostic investigations and specimen~     collection; and (iii) decrease antibiotic prescriptions.~      Study completed and manuscript accepted for publication in the Journal of Pediatrics.~   "
250101|NCT00278746|"~     Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There~     was a significant reduction in duration of the treated episodes and in their severity as~     measured by diarrheal stool output or frequency. Zinc is a potentially important~     immunomodulator or nutraceutical which may have great impact as therapeutic agent in~     conditions like diarrhea and pneumonia. The issue is whether and how zinc should be~     introduced in primary health care programs for treatment of acute diarrhea. A practical,~     sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national~     programs is therefore required. This study aimed to address this issue.~   "
250102|NCT00278733|"~     The goal of the study is to test the efficacy of brief physician advice in reducing the~     frequency of high risk drinking and alcohol-related harm in a population of university~     students seeking routine care at UBC Student Health Service. It is hypothesized that~     receiving the intervention will reduce the amount of alcohol consumed and the incidence of~     alcohol-related harm among the students in the intervention group, as compared to the control~     group.~   "
250103|NCT00278707|"~     The purpose of this study is to determine whether oral supplementation of glyceryl triacetate~     improves the clinical prognosis of Canavan Disease.~   "
250104|NCT00278694|"~     Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.~   "
250105|NCT00278681|"~     Use of zinc in diarrhea may be an effective intervention to reduce hospitalizations and child~     mortality as it could reach the most vulnerable children in a community and reduce severity~     of not only diarrhea but also of associated infections. It might also potentially reduce~     antibiotic use.~      We conducted a pilot study prior to conducting a community based controlled effectiveness~     trial to assess whether addition of zinc as a therapeutic modality for diarrhea delivered~     through existing channels, reduces visits to health care providers, antibiotic and other drug~     use, and increases ORS use during diarrhea.~   "
250106|NCT00278668|"~     We suggest to investigate serotonin uptake in schizophrenia patients receiving ECT~   "
250107|NCT00278655|"~     Multiple sclerosis is disease believed to be due to immune cells, cells which normally~     protect the body, but are now attacking the tissue in the brain and possibly the spinal cord.~     The likelihood of progression of this disease is high. This study is designed to examine~     whether treating patients with high dose cyclophosphamide and CAMPATH-1H (drugs which reduce~     the function of the immune system) followed by return of previously collected blood stem~     cells will stop the progression of your multiple sclerosis. Stem cells are undeveloped cells~     that have the capacity to grow into mature blood cells, which normally circulate in the blood~     stream. The purpose of the cyclophosphamide and CAMPATH-1H is to destroy the cells in your~     immune system which are thought to be causing your disease. The purpose of the stem cell~     infusion is to restore the body's blood production, which will be severely impaired by the~     high dose chemotherapy and to produce a normal immune system that will no longer attack the~     body.~   "
250108|NCT00278642|"~     Autoimmune Bullous Skin Disorders are believed to be due to immune cells, cells that normally~     protect the body and are now causing damage to the body. This study is designed to examine~     whether treating patients with high dose cyclophosphamide (a drug which reduces the function~     of the immune system) together with anti-thymocyte globulin (a protein that kills the immune~     cells that are thought to be causing your disease), followed by return of the previously~     collected special blood cells (stem cells) will result in improvement of this disease. Stem~     cells are undeveloped cells that have the capacity to grow into mature blood cells, which~     normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy~     the cells in the immune system which may be causing this skin disease. The purpose of the~     stem cell infusion is to restore the body's blood production, which will be severely impaired~     by the high dose chemotherapy and anti-thymocyte globulin.~   "
250109|NCT00278629|"~     Chronic inflammatory demyelinating polyneuropathy is disease believed to be due to immune~     cells, cells which normally protect the body, but are now attacking the nerves in the body.~     As a result, the affected nerves fail to respond, or respond only weakly, to stimuli causing~     numbing, tingling, pain, and progressive muscle weakness.The likelihood of progression of the~     disease is high. This study is designed to examine whether treating patients with high dose~     cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein~     that kills the immune cells that are thought to be causing disease), followed by return of~     the previously collected blood stem cells will stop the progression of CIDP. Stem cells are~     undeveloped cells that have the capacity to grow into mature blood cells, which normally~     circulate in the blood stream. The purpose of the high dose cyclophosphamide and ATG is to~     destroy the cells in the immune system. The purpose of the stem cell infusion is to evaluate~     whether this treatment will produce a normal immune system that will no longer attack the~     body.~   "
250110|NCT00278616|"~     Antiphospholipid syndrome is disease believed to be due to immune cells, cells which normally~     protect the body, but are now producing the protein which leads to abnormal clotting in the~     body. This study is designed to examine whether treating patients with high dose~     cyclophosphamide together with CAMPATH (drugs which reduce the function of the immune~     system), followed by return of the previously collected stem cells will result in improvement~     in the disease. Stem cells are undeveloped cells that have the capacity to grow into mature~     blood cells, which normally circulate in the blood stream. The purpose of the intense~     chemotherapy is to destroy the cells in the immune system which may be causing the disease.~     The purpose of the stem cell infusion is to produce a normal immune system that will no~     longer attack the body. The study purpose is to examine whether this treatment will result in~     improvement in the disease. The drugs used in this study treatment are drugs for commonly~     used for immune suppression.~   "
250111|NCT00278603|"~     Severe peripheral vascular disease of the legs causes narrowing of the blood vessels in the~     legs, which keeps the blood from flowing adequately through these vessels. This study is~     designed to examine whether treating patients with their own previously collected blood stem~     cells will improve blood flow in the most severely affected leg. Blood stem cells are~     undeveloped cells that have the capacity to grow into mature blood cells, which normally~     circulate in the blood stream.~   "
250112|NCT00278590|"~     This trial is designed to evaluate the safety of treating systemic lupus erythematosus~     participants with cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell~     transplant. There will be no randomization in this study. All subjects who are determined to~     be eligible for the study treatment will receive cyclophosphamide and CAMPATH-1H followed by~     allogeneic stem cell transplant. The purpose of the intense chemotherapy is to destroy the~     cells in the immune system which may be causing this disease. The purpose of the stem cell~     infusion is to produce a normal immune system that will no longer attack body. The study~     purpose is to examine whether this treatment will result in improvement in the lupus disease.~   "
250113|NCT00278577|"~     This disease is believed to be caused by immune cells (called lymphocytes) attacking tissue.~     Risk of death is highest in people with active acute disease. In addition, progressive~     Crohn's Disease leads to further loss of bowel function, which may eventually result in the~     need for artificial nutritional support (parenteral nutrition).~      This study involves high dose chemotherapy followed by return (infusion) of blood stem cells.~     Stem cells are undeveloped cells that have the capacity to grow into mature blood cells,~     which normally circulate in the blood stream. The high dose chemotherapy consists of~     cyclophosphamide and anti lymphocyte antibody (a protein that depletes cells that cause~     damage to the body). The purpose of the intense chemotherapy is to destroy the immune system~     completely. The purpose of the stem cell infusion is to restore the body's blood production,~     which will be severely impaired by the high dose chemotherapy and anti lymphocyte antibody.~   "
250114|NCT00278564|"~     Myositis is a disease, believed to be due to immune cells, cells which normally protect the~     body, but are now attacking the muscles and other organ systems within body. As a result, the~     affected muscles and organs fail to work properly causing weakness, difficulty swallowing,~     skin rash, respiratory problems, heart problems, joint stiffness, soft tissue calcification~     and vasculitis (blood circulation problems). The likelihood of progression of this disease is~     high. This study is designed to examine whether treating patients with high dose~     cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein~     that kills the immune cells that are thought to be causing this disease), followed by return~     of previously collected blood stem cells will stop the progression of myositis.~   "
250115|NCT00278551|"~     Rheumatoid arthritis (RA) is a chronic illness, immunologically mediated, probably induced by~     the exposure to an antigen or antigens, to which immunologic tolerance is lost. The disease~     has a variable course, from a mild, intermittently symptomatic illness requiring only~     symptomatic therapy to a fulminant illness requiring dangerous immunosuppressive therapy,~     surgery or both. The molecular defect causing RA has not been characterized, but may involve~     aberrant T cell, B cell, and macrophage function. Although RA often responds to~     immunosuppressive medication including corticosteroids, methotrexate, azathioprine and~     cyclophosphamide, or to non-steroidal anti-inflammatory drugs, no therapy has been curative.~     In patients with severe RA, who have been unresponsive to corticosteroids, and who have more~     than 20 active joints or vasculitis, we propose, as a phase I-II study, complete immune~     ablation and subsequent reconstitution with autologous in vitro T lymphocyte depleted PBSCs~     harvested from the patient prior to immune ablation. The combination of high dose~     cyclophosphamide and anti-thymocyte globulin conditioning will be followed by rescue with~     autologous lymphocyte depleted PBSCs. Subsequent disease activity will be followed by: (1) RA~     disease activity index, (2) type and amount of therapy for RA, and (3) flow cytometry of~     peripheral blood lymphocyte subsets, (4) joint count, (5) patients' assessment of pain, (6)~     arthritis impact measurement scales (AIMS) questionnaire, (7) acute phase reactants. This~     study will dose standard therapy, i.e. immune suppression, to the point of complete immune~     ablation and subsequent recapitulation of lymphocyte ontogeny by PBSC rescue. We anticipate~     that this study will also form the basis to clarify further the role of the immune system in~     RA.~   "
250116|NCT00278538|"~     This study is designed to examine whether treating patients with lupus with high dose~     cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune~     system), followed by return of their previously collected stem cells will result in~     improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow~     into mature blood cells, which normally circulate in the blood stream. The purpose of the~     intense chemotherapy is to destroy the cells in the immune system which may be causing this~     disease. The purpose of the stem cell infusion is to produce a normal immune system that will~     no longer attack body. The study purpose is to examine whether this treatment will result in~     improvement in the lupus disease.~   "
250155|NCT00277992|"~     Children with HLHS have a history of poor enteral intake and growth. Over the past several~     years a modification to the Norwood operation was instituted (RV to PA shunt in place of the~     standard Blalock-Taussig shunt).~      The purpose of this study is to evaluate whether children who underwent this modification of~     the Norwood procedure had improved growth compared to those in past years who underwent~     traditional Norwood.~   "
250117|NCT00278525|"~     Scleroderma is a systemic disorder categorized as an immunologically mediated disease that~     causes collagen deposition of skin and visceral organs. The molecular pathogenesis of~     scleroderma has been elusive, although vasculopathy and immune mediated mechanisms are~     thought to be important. Once extensive cutaneous or visceral disease occurs, prognosis is~     significantly shorter than the general population. Although various treatments have been~     tried, none of them seems to have changed the natural history of scleroderma. Standard dose~     immunosuppressive treatment has been disappointing. Recently, cyclophosphamide at 1-2~     mg/kg/day orally or 800-1400 mg intravenous (IV) monthly for 6-9 months has proven effective~     in treatment of scleroderma alveolitis (1). Recent phase I studies of immunoablation with~     autologous peripheral blood stem cell transplantation (PBSCT) showed some promising data, but~     the exact efficacy is undetermined (2,3). We now propose, as a phase II randomized study,~     autologous unmanipulated PBSCT versus pulse cyclophosphamide in patients with systemic~     scleroderma.~   "
250118|NCT00278512|"~     The systemic vasculitis is a wide-ranging group of diseases that are characterized by the~     presence of blood vessel inflammation (1). Despite this common feature, each type of~     vasculitis has a unique variety of clinical manifestations that influences its degree of~     disease severity and ultimately its management. Immunosuppressive therapy forms the~     foundation of treatment for almost all forms of systemic vasculitis.~      The systemic necrotizing vasculitis (SNV) are a subset of vasculitis with significant~     morbidity and mortality (2). The SNV are Wegener's granulomatosis, allergic angiitis and~     granulomatosis (AAG) (also known as Churg-Strauss syndrome), polyarteritis nodosum (PAN),~     microscopic polyangiitis (MPA), and overlap syndrome. In spite of modern therapeutic immune~     suppressive agents, there remains a not inconsequential morbidity and mortality associated~     with SNV. The current standard therapy for SNV is chronic oral cyclophosphamide (1-3~     mg/kg/day) and corticosteroids (3-6). Transplant doses of cyclophosphamide at 200 mg/kg~     infused over 4 days is the most common worldwide transplant regimen for systemic lupus~     erythematosus (SLE) (7). Like SLE, SNV are cyclophosphamide responsive disease. We,~     therefore, propose a trial of high dose cyclophosphamide with anti-thymocyte globulin (ATG)~     for patients with SNV.~   "
250119|NCT00278499|"~     The purpose of this study is to collect data on the HIV strains currently circulating among~     female sex workers (FSWs) and their clients. In addition, this study will identify potential~     participants for future studies.~   "
250120|NCT00278486|"~     ARRON is a disease believed to be due to immune cells, cells which normally protect the body,~     but are now attacking the tissue in the retina and/or optic nerve. In addition, the disease~     may affect the nerves in the ear or other parts of the body . The affected nerves fail to~     respond, or respond only weakly, to stimuli causing numbing, tingling, pain, and progressive~     muscle weakness. If the nerves to the ear are affected, reduced hearing or deafness may~     result. The likelihood of progression of your disease is high. This study is designed to~     examine whether treating patients with high dose cyclophosphamide and rabbit ATG (drugs which~     reduce the function of the immune system) followed by return of previously collected blood~     stem cells will stop the progression of ARRON syndrome. Stem cells are undeveloped cells that~     have the capacity to grow into mature blood cells, which normally circulate in the blood~     stream. The purpose of the cyclophosphamide and rabbit ATG is to destroy the cells in the~     immune system which are thought to be causing this disease. The purpose of the stem cell~     infusion is to restore the body's blood production, which will be severely impaired by the~     high dose chemotherapy and to produce a normal immune system that will no longer attack the~     body.~   "
250121|NCT00278473|"~     This study will determine the effectiveness of group cognitive-behavioral therapy as compared~     to a problem-solving social support group in treating problems of time management,~     organization, and planning in adults with attention deficit hyperactivity disorder (ADHD).~   "
250122|NCT00278460|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel~     works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.~   "
250123|NCT00278447|"~     The objective of this study is to test whether a chronic disease management (CDM) program for~     substance abusers in primary care leads to improved alcohol and drug-related outcomes (such~     as reduced consumption and health problems) and health care utilization patterns.~   "
250124|NCT00278434|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep tumors from forming, growing,~     or coming back. Zoledronate may prevent the growth of cervical cancer by blocking blood flow~     to cervical intraepithelial neoplasia cells. The use of zoledronate may keep cancer from~     forming.~      PURPOSE: This randomized is studying how well zoledronate works in treating patients with~     cervical intraepithelial neoplasia 2/3 or 3.~   "
250125|NCT00278421|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others~     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,~     such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.~     It is not yet known which schedule of rituximab and combination chemotherapy is more~     effective in treating non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and~     combination chemotherapy to compare how well they work in treating patients with aggressive~     B-cell non-Hodgkin's lymphoma.~   "
250156|NCT00277979|"~     Pompe's disease, also known as glycogen storage disease type II, is a genetic disorder due to~     deficiency of acid glucosidase (GAA), which results in lysosomal glycogen storage in various~     tissues.~      Very low levels of GAA usually present in infancy, lead to a progressive cardiac and skeletal~     muscle disorder and death before age 1 year.~      Most infants develop massive hypertrophic cardiomyopathy which progresses to dilated~     cardiomyopathy and cardiorespiratory arrest.~      3D echocardiography can be a simple, non-invasive method of following cardiac disease~     progression in infantile Pompe's disease.~   "
250157|NCT00277966|"~     In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a~     Quality Improvement Review examining radiation exposure.~   "
250126|NCT00278408|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others~     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,~     such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving~     rituximab and combination chemotherapy together with radiation therapy may kill more cancer~     cells. It is not yet known which schedule of rituximab and combination chemotherapy is more~     effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and~     combination chemotherapy with or without radiation therapy to compare how well they work in~     treating patients with aggressive B-cell non-Hodgkin's lymphoma.~   "
250127|NCT00278395|"~     This phase II trial is studying how well vorinostat works in treating patients with advanced~     kidney cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Vorinostat may also stop the growth of tumor cells by blocking blood flow to the tumor.~   "
250128|NCT00278382|"~     Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by~     blocking some of the enzymes needed for cell growth. This phase II trial is studying how well~     sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's~     lymphoma~   "
250129|NCT00278369|"~     RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry~     tumor-killing substances directly to kidney cancer cells. Interleukin-2 may stimulate the~     white blood cells to kill kidney cancer cells. Giving denileukin diftitox together with~     interleukin-2 may kill more tumor cells.~      PURPOSE: This randomized phase I trial is studying the side effects of denileukin diftitox~     and interleukin-2 in treating patients with metastatic kidney cancer.~   "
250130|NCT00278343|"~     This phase II trial is studying how well cediranib maleate works in treating patients with~     persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or~     fallopian tube cancer. Cediranib maleate may stop the growth of tumor cells by blocking blood~     flow to the tumor and by blocking some of the enzymes needed for cell growth.~   "
250131|NCT00278330|"~     This phase I trial is studying the side effects and best dose of flavopiridol when given~     together with vorinostat in treating patients with relapsed or refractory acute leukemia or~     chronic myelogenous leukemia or refractory anemia. Flavopiridol and vorinostat may cause~     leukemia cells to look more like normal cells, and to grow and spread more slowly. Vorinostat~     may also stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Giving flavopiridol together with vorinostat may be an effective treatment for~     leukemia or refractory anemia.~   "
250132|NCT00278304|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation~     uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving~     radiation therapy in different ways may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving external-beam radiation together~     with internal radiation works in treating patients with cervical cancer.~   "
250133|NCT00278278|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy~     x-rays to kill tumor cells. It is not yet known whether giving methotrexate together with~     combination chemotherapy and radiation therapy is more effective than combination~     chemotherapy and radiation therapy alone in treating gliomas.~      PURPOSE: This randomized phase III trial is studying giving methotrexate together with~     combination chemotherapy and radiation therapy to see how well it works compared to~     combination chemotherapy and radiation therapy alone in treating young patients with newly~     diagnosed gliomas.~   "
250134|NCT00278265|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate and fludarabine, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing.~      PURPOSE: This phase II trial is studying how well methotrexate works as first-line therapy~     and fludarabine works as second-line therapy in treating patients with T-cell large granular~     lymphocytic leukemia.~   "
250135|NCT00278252|"~     RATIONALE: Drugs used in chemotherapy, such as etoposide, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well etoposide works in treating young patients~     with ependymoma.~   "
250136|NCT00278239|"~     RATIONALE: Questionnaires that measure quality of life may improve the ability to plan~     treatment for patients with primitive neuroectodermal tumors.~      PURPOSE: This phase III trial is studying quality of life in patients who have undergone~     previous treatment for primitive neuroectodermal tumors.~   "
250137|NCT00278226|"~     RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from~     forming.~      PURPOSE: This clinical trial is studying how well a motivational program works in helping~     smokers enrolled in a methadone maintenance program quit smoking.~   "
250138|NCT00278213|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and~     mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can~     block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others can find cancer cells and help kill them or carry cancer-killing substances to~     them. Combination chemotherapy followed by alemtuzumab may be effective in treating chronic~     lymphocytic leukemia and prolymphocytic leukemia.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by~     alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia or~     prolymphocytic leukemia.~   "
250139|NCT00278200|"~     RATIONALE: Vaccines made from a person's white blood cells may help the body build an~     effective immune response.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating~     patients who are being considered for solid organ transplant who are at risk for~     post-transplant lymphoproliferative disorder.~   "
250142|NCT00278161|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Colony-stimulating factors, such as~     pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral~     blood and may help the immune system recover from the side effects of chemotherapy. Giving~     rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating~     leukemia or non-Hodgkin's lymphoma.~      PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide~     together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade~     non-Hodgkin's lymphoma, or mantle cell lymphoma.~   "
250143|NCT00278148|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving erlotinib, paclitaxel, and carboplatin together with radiation therapy before surgery~     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~     Giving these treatments after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase I/II trial is studying the best dose of erlotinib and the side effects of~     erlotinib, paclitaxel, and carboplatin when given together with radiation therapy and to see~     how well they work in treating patients who are undergoing surgery for stage III non-small~     cell lung cancer.~   "
250144|NCT00278135|"~     The purpose of this study is to investigate the effect of docosahexaenoic acid (DHA, 22:6n-3)~     in improving cognitive functions in subjects with age-related cognitive decline. DHA is a~     long chain omega-3 fatty acid (LC-PUFA) that plays an important role in neural and visual~     development and cardiovascular health.~   "
250145|NCT00278122|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and~     stop tumor cells from growing. Giving paclitaxel together with GM-CSF may be effective in~     treating melanoma.~      PURPOSE: This phase II trial is studying how well giving paclitaxel together with GM-CSF~     works in treating patients with stage III or stage IV melanoma that cannot be removed by~     surgery.~   "
250146|NCT00278109|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     radiation therapy together with cyclophosphamide and doxorubicin after surgery may kill any~     tumor cells that remain.~      PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when given~     together with cyclophosphamide and doxorubicin and to see how well they work in treating~     women with stage I or stage II breast cancer who have undergone surgery.~   "
250147|NCT00278096|"~     In this study we aim to assess whether unsolicited occupational therapy compared to no~     therapy can decelerate the increase in disability in high-risk elderly.~   "
250148|NCT00278083|"~     This trial is a randomised, single-center, placebo-controlled, double blind, parallel group~     study in patients with asthma symptomatic on inhaled steroids.~      This trial will examine the efficacy and safety of 5 mg/kg doses of infliximab in patients~     with inhaled corticosteroid-dependent asthma. The primary objective of this study is to~     obtain pharmacological evidence for a role of the pro-inflammatory cytokine TNF-alpha in~     patients with asthma symptomatic on inhaled steroids and to evaluate the safety and~     tolerability of repeated intravenous administration of infliximab.~   "
250149|NCT00278070|"~     Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three~     different doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomic~     schedule three times a week: on Monday, Wednesday and Friday.~   "
250150|NCT00278057|"~     We wanted to test the hypotheses that blood pressure level was lower, that the variability of~     blood pressure and blood glucose was reduced, and that quality of life was improved when~     glucose was added to the dialysis fluid.~   "
250151|NCT00278044|"~     Study the clinical manifestations and gene mutation of Taiwanese ALD patients~   "
250152|NCT00278031|"~     The aim of the study is to assess the quality of life of children who have been cured of~     retinoblastoma - a malignant eye tumor. The study is questionnaire-based, and uses~     standardized quality of life assessment tools.~   "
250153|NCT00278018|"~     Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized,~     this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy~     represents an approach to treatment based on the immune response to cancer antigens.~      The long-term objective of this study is to develop a therapeutic approach for the treatment~     of cancer in general, and melanoma in particular, based on immunotherapy, using a combination~     of local tumor irradiation followed by injection of immature dendritic cells (iDC).The~     treatment will be followed by the injection of interferon alpha, which we expect will induce~     activation of the iDC.~      This trial is based on the hypothesis that local radiation, which causes destruction of the~     tumor, in combination with injection of the patient's own iDC and the activation of these~     cells with interferon alpha, will induce an effective immune response against the tumor. In~     order to test the suggested approach, we propose a 20-patients clinical trial that will~     evaluate the objective clinical and immunological response to the proposed treatment in~     patients with malignant melanoma and other solid tumors.~   "
250154|NCT00278005|"~     We propose a retrospective review of patients with DiGeorge syndrome having undergone cardiac~     surgery to evaluate the incidence of blood stream and/or surgical site infection. The~     hypothesis is that we will find an increased number of infections for this sub-group. We will~     compare the incidence of infection to children of similar age and diagnosis to evaluate for~     variances in the incidence of infection.~   "
250210|NCT00277225|"~     The purpose of this protocol is to determine the single-dose pharmacokinetics and~     immunogicity of BMS-188667 administered as a 1 hour intravenous infusion with extended~     pharmacokinetic sampling. Safety of all subjects will be assessed in a double blind fashion~     through the inclusion of placebo controls at each dose level.~   "
250158|NCT00277953|"~     To date, there have been no published reports of normal variations in tracheal dimensions for~     pediatric patients undergoing MRIs. While there are reports of normals in CT studies, the~     reported dimensions were for average areas and lengths over the entire length of the trachea~     and not for normal variation in the dimensions at various sites in the trachea. Moreover, CT~     measurements are likely not entirely applicable to MRI measurements. Since cardiac MRI has~     become the procedure of choice to document the presence of vascular rings as well as the~     significance of any ring that is found, there is a need for normal values to be generated.~     This would in turn permit physicians to determine in cases of documented vascular rings the~     severity of the tracheal stenosis/deformity if found.~   "
250159|NCT00277940|"~     Abnormalities of the aorta have been identified in patients who have undergone repair of~     coarctation of the aorta by various surgical techniques. These abnormalities are thought to~     contribute to ventricular hypertrophy, hypertension and exercise intolerance. Aortic arch~     reconstruction is performed for a variety of lesions besides simple coarctation of the aorta;~     these include hypoplastic left heart syndrome and its variants. In the latter group of~     patients extensive reconstruction is performed usually with a pulmonary homograft. We have~     previously shown that the neo-aortic dimensions and geometry are abnormal. The elastic~     properties of the neo-aorta, however, have not previously been described.~   "
250160|NCT00277927|"~     Mild valvar pulmonary stenosis can be detected in 1/10,000 live births. Historical data~     suggested that most of these patients do well. Nonetheless, the majority of these patients is~     followed periodically by a pediatric cardiologist and may undergo repeated echocardiographic~     studies to follow the gradient. Such follow-up can be costly and it is not know if there is~     any benefit to periodic evaluation.~   "
250161|NCT00277914|"~     To estimate the duration of efficacy with continued treatment of double-blind flibanserin or~     placebo over twenty-four weeks of treatment.~   "
250162|NCT00277901|"~     At Children's Healthcare of Atlanta at Egleston, it is standard of care to do a cardiac MRI~     on patients with the diagnosis of Tetralogy of Fallot and Aortic Coarctation to evaluate~     heart function. We propose to do a retrospective chart review of patient data along with~     their MRI data to analyze ventricular function and cavity volumes pre-Tetralogy of Fallot~     repair, post-Tetralogy of Fallot repair (pre-valve repair/replacement) and post-valve~     repair/replacement in order to assess the efficacy and optimal timing of valve replacement.~   "
250163|NCT00277888|"~     The purpose of this study is to determine whether a jugular route leads to a lower rate of~     complications as compared with a femoral route for catheterization in patients admitted in~     several intensive care units in France who develop acute renal failure requiring~     hemodiafiltration or hemodialysis.~   "
250164|NCT00277875|"~     Determine whether increasing arterial distensibility by decreasing advanced glycation~     end-product (AGE) cross-link components of vascular stiffness improves (a)~     endothelial-mediated vasoreactivity at rest, as assessed by flow-mediated vasodilation (FMD),~     and (b) endothelial-mediated vasoreactivity after exercise, as assessed by pulse~     perfusion-mediated vasodilation (PPMV).~   "
250165|NCT00277862|"~     Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to~     treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to~     conventional interferon monotherapy. Recent reports showed that pegylated interferon and~     ribavirin combination therapy markedly increased the SVR rate to 55-70%. The duration of~     treatment has not been accurately defined. The main objective of this is to assess the~     duration of pegylated interferon ribavirin therapy in chronic hepatitis genotype 4 and assess~     the clinical utility of rapid and early virologic response in determining the optimal~     duration of peg interferon ribavirin therapy in chronic hepatitis C.~   "
250166|NCT00277849|"~     This study will collect blood samples for use in laboratory studies of malaria. The World~     Health Organization reports that 40 percent of the world's population is at risk for malaria,~     mostly in the poorest countries. It is a serious disease caused by parasites. Each year,~     300-500 million infections lead to more than a million deaths. However, there are traits in~     red blood cells (erythrocyte) that protect people against malaria. In this study,~     polymorphism refers to the various kinds of red blood cell traits.~      The sickle cell trait is an example of one that seems to offer a natural survival advantage~     in children where malaria is common. Researchers at the Laboratory of Malaria and Vector~     Research are investigating ways in which the blood cell traits can offer such protection, and~     new knowledge gained can bring about medical advances. Of particular importance is studying~     how the malaria organism, Plasmodium, survives inside different red blood cells. A steady,~     consistent, and reliable supply of fresh whole blood is necessary for testing.~      Patients 18 to 65, weighing more than 110 lbs. and who do not have anemia or known HIV,~     Hepatitis C, or Hepatitis B may be eligible for this study.~      Patients will undergo a medical history and general assessment including vital signs of~     temperature, heart rate, and blood pressure. Blood will be collected from a vein in the arm,~     or rarely a vein in the hand. A complete blood count, or CBC, will be done to ensure that~     blood levels are sufficient and that blood donation is safe for a patient to do. Patients~     need to have enough hemoglobin, the part of red blood cells that transports oxygen throughout~     the body. The blood will also be tested to confirm the type of red blood cell traits of~     patients. About 1 to 8 tablespoons may be collected, but most blood samples will be small,~     that is, 1 to 4 teaspoons. After the patients' first visit, sessions will take 5-20 minutes.~     Blood collection will total no more than 2 cups from a donor during any 6-week period.~     Although the frequency of blood donations is not known at this time, it is unlikely that a~     patient will be asked to donate blood more than four times a year. It may be important for~     patients to undergo a repeat CBC or tests for blood chemistry if results are needed for~     research. Risks associated with blood collection are considered minimal. They include~     discomfort, occasional bruising or bleeding at the puncture site, and faintness.~      In this study, it is possible that a small amount of blood may be stored for future research,~     to help the researchers to learn more about malaria. There are no plans for the results from~     the various research laboratory tests to be made available to patients or to their private~     doctors. However, patients in this study may discuss the results of routine medical tests~     with the study investigators. Some of the blood collected will be tested for genetic~     conditions. Through genetic testing, researchers can learn more about how health or illness~     may be passed on to people by their parents, or from people to their children. All results of~     tests will remain confidential. Blood samples will be labeled by code, and reference to~     patients' identities will be protected.~      Participants will receive $50 for each blood donation. This study will not have a direct~     benefit for participants. Future research that uses their blood samples will help researchers~     to learn about malaria as well as how to prevent or treat the disease.~   "
250167|NCT00277836|"~     MST-997 is a taxane analog with the potential to treat subjects with a variety of tumor~     types. Preclinical data demonstrated that MST-997 inhibited tumor growth when administered~     intravenously (IV). This phase 1 dose escalation study is designed to evaluate the safety and~     tolerability of if IV MST-997 formulated in Polysorbate 80 Diluent can be safely administered~     on a weekly basis.~   "
250168|NCT00277823|"~     The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability~     of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects~     receiving placebo.~   "
250169|NCT00277810|"~     The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of~     lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate~     Alzheimer's disease (AD).~   "
250170|NCT00277797|"~     Low back pain is a common condition, which extols a large cost to society from lost wages~      The Biowave System was developed by Biowave Corporation (Biowave), Norwalk, CT. Two wires~     emanate from the unit. The feed wire is attached to a large disposable input pad (Feed~     Electrode). The return wire is attached to a smaller pad (Return Electrode) over the~     source of the pain (the treatment site).~      The device sends a premixed modulated envelope of two high frequency electronic wave forms~     (Feed Signal) between the two electrodes. The beat frequency of the modulated envelope~     (d-Frequency) is equal to the difference in frequency of the two feed signals. The location~     of beat frequency formation is dependent on the size and location of the two electrodes. With~     the configuration used in the study, the beat frequency signal is believed to form~     immediately ventrally to the Return electrode. The size of the volume of tissue affected can~     be changed and is dependent upon electrode geometry and the amplitude of the Feed Signal. The~     beat frequency is a low frequency blocking signal which is believed to cause a demodulation~     in the nerve cells and a reduction of the sodium/potassium ion exchange. As a result, the~     charge polarity of the nerve cell wall is prevented from changing and is therefore unable to~     transmit pain impulses. The size of the volume of tissue affected can be changed and is~     dependent upon electrode geometry and the amplitude of the Feed Signal.~      The objective of this study is to compare the Biowave System with TENS (a currently available~     treatment) and to further evaluate its efficacy for the relief of pain in patients with~     chronic low back pain.~   "
250211|NCT00277212|"~     Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance~     Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode~   "
250212|NCT00277199|"~     Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS-188667~     in Healthy Subjects~   "
250171|NCT00277784|"~     The macula is the site of central vision within the retina. The retina is oxygenated by the~     underlying choroid. These tissues are less than 1 mm thick in total. While optical techniques~     can reveal much about the structure of the retina, ultrasound allows imaging of the choroid~     and deeper tissues. This study will investigate use of high frequency (20 MHz) ultrasound for~     imaging of the retina and choroid in patients with age-related macular degeneration, a prime~     cause of blindness. The investigation will involve use of novel post-processing methodologies~     to achieve maximum resolution of the fine tissue structures involved in this disease.~   "
250172|NCT00277771|"~     We propose to conduct a randomized study of standard behavioral weight-loss treatment to test~     if using an electronic diary with or without tailored feedback will improve adherence to~     self-monitoring and subsequently improve weight loss. Subjects will be randomly assigned to~     different methods to self-monitor food and exercise habits: (1) use of the traditional paper~     diary , (2) use of a personal digital assistant (PDA), or (3) use of a personal digital~     assistant that also provides daily feedback.~   "
250173|NCT00277758|"~     This is a treatment study trial, in which we will assess the safety and tolerability of daily~     dose IL-2, as monotherapy for 12 weeks, followed by IL2 in combination with PEG-IFN and RBV~     for 48 weeks in the treatment of chronic Hepatitis C.~   "
250174|NCT00277745|"~     This study is being conducted to test the ability and accuracy of a new instrument in the~     diagnosis of periodontitis (gum disease) by using fluids from the mouth. The diagnosis~     instrument will test two types of fluids, gingival crevicular fluid (GCF) and saliva. GCF is~     the fluid that accumulates between your teeth and gum tissue. The fluids will be collected in~     three ways: 1. Direct GCF sampling 2. GCF rinse sampling and 3. Whole saliva. A total of 100~     adult patients will participate in this study. These subjects will be of two patient~     populations: 1) diseased population, with active gum disease; and 2) a low-risk disease~     population, with no active gum disease. Patients will be seen 6 times over the course of the~     study over a period of approximately 12 months. At each visit the patient will undergo oral~     fluid collection, as previously described, and thorough examinations of the mouth, including~     the taking of measurements for study purposes. Patients will also have radiographs taken at~     baseline, month 6, and end of study visits.~   "
250175|NCT00277732|"~     The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity~     of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to~     the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical~     care at baseline and follow-up visits over 6 months).~   "
250176|NCT00277706|"~     Parathyroid hormone (PTH) has potent bone-building actions and has been approved for the~     treatment of osteoporosis as FORTEO by Eli Lilly & Co. Numerous studies have verified its~     effectiveness in increasing bone mass and potential for PTH to positively impact oral bone.~     The hypothesis of this study is that patients administered FORTEO along with periodontal~     (gum) surgery will respond more favorably than patients who receive placebo.~      There will be 40 subjects enrolled in this study. All subjects will receive surgical~     treatment. 20 subjects will receive FORTEO and 20 will receive placebo. Subjects will be~     assigned to study group randomly. Neither the subjects nor the clinicians will know whether~     the subject is receiving FORTEO or placebo.~      Patients will undergo routine periodontal treatment procedures including periodontal surgery.~     Starting from 3 days prior to surgery, all subjects will self-administer FORTEO or placebo~     for 6 weeks. Subjects will be trained for self-administration, a procedure similar to~     diabetic injections. Patients will also take Vitamin D and Calcium by mouth during this time.~     Study outcomes will be measured by blood collection; oral fluid sampling; oral x-ray and~     spine and hip bone density scan; routine periodontal examinations; and an oral health quality~     of life questionnaire.~      Patients of both genders and all ethnicities from age 30-75 years will be included in the~     study. All ethnicities are eligible for entry into study. No vulnerable populations will be~     included. Pregnant/breast-feeding women and women of childbearing potential on no~     contraception will be excluded from the study. Research records will not be linkable to the~     research subjects. Subjects will be randomly assigned to treatment arms and identified by~     initials and numbers. Informed consent forms will be used to obtain consent for participation~     in the study from all subjects prior to enrollment. The Principal Investigator or~     Co-Investigator will explain the details of study involvement and give subjects ample~     opportunity to ask questions.~      It is anticipated that patients on FORTEO will have greater regeneration with periodontal~     therapy as compared to control patients.~   "
250177|NCT00277693|"~     The purpose of the present study is to determine if spironolactone is safe and effective in~     the treatment of cardiovascular complications in hemodialysis patients.~   "
250178|NCT00277680|"~     Women with symptomatic uterine fibroids are treated either by Uterine Fibroid Embolization~     (UFE) or laparoscopic occlusion. The study hypothesis is that laparoscopic occlusion of~     uterine vessels and UFE have equal effect on bleeding symptoms. Menstrual bleeding reduction~     six months after treatment is the main endpoint. Secondary endpoints include participants~     assessment of symptom relief, and volume reduction of fibroids measured by MRI. We will also~     investigate possible differences in postoperative course, symptom reduction, complication,~     and recurrence. Patients are controlled with regular intervals up to five years after~     treatment.~   "
250179|NCT00277667|"~     The purpose of this research study is to evaluate the safety, tolerability, and efficacy of~     quetiapine compared to placebo (sugar pill without medication) in the treatment of bipolar~     disorder with moderate to severe hypomania or mild mania. Quetiapine is approved by the~     United States Food and Drug Administration (FDA) for the treatment of schizophrenia and~     bipolar mania.~   "
250180|NCT00277654|"~     The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how~     well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment~     of bipolar disorder with panic disorder or generalized anxiety disorder. Risperidone is~     currently approved by the United States Food and Drug Administration (FDA) for the treatment~     of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the~     treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder~     (the condition being investigated in this study).~   "
250181|NCT00277641|"~     This research study is to evaluate the effectiveness, tolerability, and safety of lamotrigine~     therapy in the treatment of binge eating disorder associated with obesity.~      Lamotrigine has been approved by the Food and Drug Administration for the treatment of~     bipolar disorder, but has not been approved for use in the treatment of binge eating disorder~     with obesity.~   "
250182|NCT00277615|"~     The purpose of this study is to evaluate a novel ultrasound bladder scanning device designed~     particularly for children in children with bladder dysfunction.~   "
250213|NCT00277186|"~     The study aims to determine if a New Arthroplasty Care Model, established on evidence-based~     medicine and best practices, will improve patient outcomes and improve cost effectiveness for~     patients with severe degenerative joint disease of the hip or knee in Alberta~   "
250183|NCT00277602|"~     Primary objective:~        -  The primary objective of the study is to establish that riluzole slows down (1) the~          decrease in total functional capacity (TFC), (2) the increase of the motor score of the~          Unified Huntington's Disease Rating Scale (UHDRS) as well as (3) the increase of a~          combined score of these.~      Secondary objectives:~      Secondary objectives are to assess~        -  changes in the other UHDRS subscales~        -  the number of patients who need antichoreic treatment and the time until this treatment~          has to be initiated~        -  the safety/tolerability of riluzole in Huntington patients~   "
250184|NCT00277589|"~     Primary objective:~        -  To evaluate change in total volume of all nodules.~      Secondary objectives:~        -  To evaluate change in goiter volume after a 12-months treatment, number of nodules and~          echogenicity of nodules.~   "
250185|NCT00277576|"~     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where~     administrations are given and any effects it may have on subjects' wellbeing. The study will~     also test the ability of vaccine to reduce hepatitis B disease.~   "
250186|NCT00277563|"~     Pulsed electromagnetic fields (PEMF) have been approved by FDA and are utilized currently in~     treating non-union fractures, neurogenic bladder and musculoskeletal pains. Based on 2 prior~     pilot studies (open label) demonstrating reduction in neuropathic pain from carpal tunnel~     syndrome we decided to perform a placebo-controlled trial, randomized for 2 months utilizing~     a wrist PEMF device attached by Velcro for 4 hours/day.~   "
250187|NCT00277550|"~     To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in~     female patients with CC and upper GI symptoms of dyspepsia~   "
250188|NCT00277537|"~     Study will assess the safety and effectiveness of 12 week treatment with the study~     medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have~     trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol~     inhalation may help to facilitate the clearance of mucus by altering its rheology (making it~     less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On~     completion of the double blind phase, subjects will have the opportunity to participate in a~     52 week open label phase.~   "
250189|NCT00277524|"~     The purpose of the OMNI study is to characterize therapy and diagnostic utilization in study~     participants implanted with study devices and to describe Implantable Cardioverter~     Defibrillator(ICD)therapy utilization for life threatening arrhythmias in primary and~     secondary prevention study participants. This study will assess therapies in Medtronic~     pacemaker, defibrillator, and cardiac resynchronization therapy devices.~      The first therapy is for reducing unnecessary pacing in pacemaker patients. The second~     therapy provides pacing therapy in an attempt to stop fast or life threatening ventricular~     arrhythmias in lieu of delivering a defibrillation shock. The third therapy is a diagnostic~     measurement of a patient's fluid status and provides the physician information on the~     patient's heart failure status.~      The study will also assess the time to a patient's first defibrillation shock and will verify~     that the shock was for a fast or life threatening ventricular rhythm.~   "
250190|NCT00277511|"~     Primary objective:~        -  To investigate the microbiological efficacy, assessed as eradication rate based on~          microbiologically evaluable patients 1 month post treatment with oral Levofloxacin 500~          mg in male adults with chronic bacterial prostatitis (CBP, category II)~      Secondary objectives:~        -  To investigate the microbiological efficacy, assessed as eradication rate based on~          microbiologically evaluable patients 6 months post treatment with oral Levofloxacin 500~          mg in male adults with chronic bacterial prostatitis (CBP, category II).~        -  To assess the clinical response rate based on resolution of signs and symptoms after 2~          weeks of treatment; 5-12 days, 1 month, 3 months and 6 months post treatment with oral~          Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category~          II).~        -  To assess the safety of Levofloxacin 500 mg on the basis of adverse events, standard~          clinical chemistry, hematology, urinalysis and vital signs in male adults with chronic~          bacterial prostatitis (CBP, category II).~   "
250191|NCT00277498|"~     To demonstrate statistical superiority of the combination of latanoprost and timolol to the~     individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8~     AM, 10 AM, 4 PM at weeks 2, 6 and 12.~   "
250192|NCT00277472|"~     This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination~     therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.~   "
250193|NCT00277446|"~     An epidemiologic study of patients with asthma has shown that increased intake of soy~     isoflavones correlates with less severe asthma. In experimental animals, treatment with the~     soy isoflavone genistein reduces airways inflammation and hyper-responsiveness. In vitro~     studies performed by us have shows that genistein reduces release of inflammatory compounds~     by human blood eosinophils. The purpose of this pilot study is to determine whether dietary~     supplementation with soy isoflavones has effects in patients with asthma. 20 patients with~     asthma will supplement their diet with a soy isoflavone capsule for 4 weeks. Before and after~     the supplementation period, we will measure lung function, exhaled nitric oxide (a marker for~     airway inflammation), collect exhaled breath condensate to measure levels of inflammatory~     mediators in the airways, and isolate peripheral blood eosinophils to assess the impact of~     soy isoflavones on their function. We hypothesize that dietary supplementation with soy~     isoflavones will reduce exhaled nitric oxide level, reduce the inflammatory mediators in the~     exhaled breath condensate, and reduce the ability of eosinophils to release inflammatory~     molecules. Identifying if these hypothesized effects of soy isoflavones exist in asthma will~     provide a justification for further clinical studies.~   "
250194|NCT00277433|"~     The primary goal of the study is to investigate the impact of a common genetic polymorphism~     in a histamine detoxification enzyme that may well have a common role in regulating the~     expression of atopic dermatitis (AD) and other related atopic diseases in children.~   "
250195|NCT00277420|"~     This project aims to conduct a unique, community-based intervention consisting of a~     randomized trial of a culturally-appropriate weight loss intervention for overweight Latino~     children in Milwaukee. The intervention promotes lifestyle changes through a low weight loss~     regimen, one or more physical activities ranging from soccer to hip-hop dance, and dietary~     counseling including cooking classes for parents. In addition to weight reduction for~     overweight Latino children, the project has the potential to reduce missed school days and~     improve self-esteem and quality of life.~   "
250196|NCT00277407|"~     1. Purpose of this study is to determine whether NAET procedures are effective in the~          treatment of children with allergy-related autism spectrum disorders in restoring their~          verbal and nonverbal communication.~        2. Hypothesis: Children in the experimental group will show a significant improvement over~          the control group in verbal and nonverbal communication as most food allergen groups,~          environmental allergen groups, childhood immunizations, and some other relevant~          allergenic substances are desensitized in a systematic way using NAET® procedures within~          the specified period of study.~   "
250197|NCT00277394|"~     The objective of the study is to compare the safety of innohep® and Unfractionated Heparin~     (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal~     function for initial treatment of acute Deep Venous Thrombosis (DVT).~      The primary response criterion is the percentage of patients with clinically relevant~     bleeding events prior to day 90 +/- 5.~   "
250198|NCT00277381|"~     Treating hypertension is known to decrease morbidity and mortality. Despite this 70% of~     patients do not have adequately controlled blood pressure. The main reason for this is~     non-adherence to recommended drug therapy. Although strategies have been developed to improve~     adherence many are time consuming and expensive. We propose to use communications technology~     to develop a novel means of improving adherence to antihypertensive therapy. We will conduct~     a randomised, single-blinded, controlled study to assess the impact of a real-time, automated~     reminder system on adherence rates. This will involve adapting two pieces of currently~     available technology - the electronic pill bottle and the Ambient Globe. The Globe will~     change colour in response to information received, via a wireless link, from the patient's~     electronic pill bottle. We hypothesise that this will provide patients with an up to date,~     but unobtrusive, reminder of their adherence status and thus effect positive behavioural~     change. We will measure the impact of this intervention on adherence rates as well as~     assessing patient views and the impact on provider workload. This trial will elucidate the~     role of communications technology in improving adherence behaviour and allow us to develop~     further strategies to tackle this major health issue.~   "
250199|NCT00277368|"~     The purpose of this study is to investigate the prevalence, characteristics and~     classification of headaches in epileptic patients.~   "
250200|NCT00277355|"~     This study is being conducted to assess the impact of minocycline on the progression of~     symptoms of HD. The study will also assess whether it is reasonable to continue with further~     study of minocycline in HD. We will measure the effect of minocycline on HD by measuring the~     change in Huntington's disease symptoms.~   "
250201|NCT00277342|"~     The investigators hypothesise that a common A277G polymorphism of the liver fatty acid~     binding protein (L-FABP) gene, which leads to an amino acid exchange, may be associated with~     alterations of lipid-induced hepatic insulin resistance. In the present study the~     investigators will investigate potential differences in lipid-induced hepatic insulin~     resistance, and in the relation between glycogenolysis and gluconeogenesis, in healthy~     subjects with the A277G polymorphism vs. subjects carrying the wildtype.~   "
250202|NCT00277329|"~     This clinical study is being conducted at multiple sites to determine the activity, safety,~     and tolerability of XL999 when given weekly to patients with non-small cell lung cancer~     (NSCLC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR,~     FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels~     (angiogenesis), and metastasis.~   "
250203|NCT00277316|"~     This clinical study is being conducted at multiple sites to determine the activity, safety,~     and tolerability of XL999 when given weekly to patients with metastatic clear cell renal cell~     carcinoma (RCC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR,~     PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood~     vessels (angiogenesis), and metastasis.~   "
250204|NCT00277303|"~     This clinical study is being conducted at multiple sites to determine the activity, safety,~     and tolerability of XL999 when given weekly to patients with metastatic colorectal cancer~     (CRC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR,~     FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels~     (angiogenesis), and metastasis.~   "
250205|NCT00277290|"~     This clinical trial is being conducted at multiple sites to evaluate the activity, safety,~     and tolerability of XL999 when given weekly to patients with ovarian cancer that has~     previously been treated with platinum-based chemotherapy. XL999 is a small molecule inhibitor~     of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor~     cell growth, formation of new blood vessels (angiogenesis), and metastasis.~   "
250206|NCT00277277|"~     The majority of patients with Type 2 Diabetes are obese and weight loss is known to improve~     diabetes outcomes and reduce the need for anti-diabetic medical. This 8-week Telehealth study~     will compare the effects of standard weight loss advice given in a clinic setting to weight~     loss advice delivered in the home using an interactive cable television technology called~     Healthium.~   "
250207|NCT00277264|"~     The objective of this trial is to evaluate whether the effect of one year (48 weeks)~     treatment with inhaled tiotropium bromide (Spiriva® - 18 µg once daily) on the change in~     trough FEV1, compared to placebo in patients with COPD, is affected by smoking status.~   "
250208|NCT00277251|"~     This trial will test the hypothesis that among 20 children and adolescents from Children's~     Hospital, Boston with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid~     arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue~     disease and vasculitis, treatment of glucocorticoid-associated osteopenia and osteoporosis~     with 18 months of alendronate (FOSAMAX®, Merck & Co., Inc.) will result in greater~     improvement in the mean change of individual AP spine bone mineral density (BMD) (gm/cm2)~     determined by dual energy X-ray absorptiometry (DXA) than treatment with 18 months of~     standard of care therapy.~   "
250209|NCT00277238|"~     The purpose of this study is to determine the efficacy and tolerability of CPG 10101 at two~     different dose levels with pegylated-interferon-alpha 2B (PEG-IFN) plus ribavirin (RBV)~     compared to PEG-IFN and RBV without CPG 10101 in HCV positive subjects who were classified as~     non-responders to previous adequate PEG-IFN plus RBV therapy.~   "
250214|NCT00277173|"~     The purpose of this study is to determine whether a CRM (adapted Crew Resource Management~     approach proven successful in aviation as well as some inpatient medical settings)~     intervention is effective for reducing medication errors among older adults in primary care~     settings.~   "
250216|NCT00277147|"~     This study will evaluate a new (conjugate) vaccine for typhoid fever, which remains a serious~     disease especially difficult to treat in developing countries. Salmonella typhi, the bacteria~     causing typhoid fever, have become resistant to several antibiotics increasing the difficulty~     of treating the disease. The disease may have serious complications effecting bones, brain,~     and intestines, with permanent injury or death. Methods to control typhoid fever, such as a~     sanitary water and food supply, along with effective sewage treatment, are not likely to be~     available soon in those countries.~      NIH scientists developed a vaccine called Vi, made of a polysaccharide (a chain of linked~     sugars) from the surface of Salmonella typhi, the bacteria that cause typhoid fever. It has~     been approved by the World Health Organization and is licensed in 94 countries. It is~     effective in adults but not in young children. Clinical trials have shown that chemically~     binding the Vi to a protein to form a conjugate vaccine has improved and extended its~     efficacy to children (conjugate vaccines to other bacteria, notably meningitis causing~     bacteria have been used extensively and successfully). Now NIH scientists have developed~     another vaccine for typhoid fever - using a polysaccharide from fruit, known as pectin. The~     pectin has been chemically treated so that it resembles Vi. The treated pectin, O-acetyl~     pectin, is bound to a protein; exoprotein A, (rEPA). The result is a conjugate, as was formed~     for Vi. Similarly to the Vi conjugate it induces antibodies against Salmonella typhi in~     laboratory animals. If the O-acetyl pectin conjugate proves successful, it will be evaluated~     in children ages 5 to 14 years old and in infants, toward using it with routine vaccines for~     infants.~      Volunteers ages 18 to 45 who do not have an allergy to fruit pectin and who have not been~     vaccinated against nor had typhoid fever within the last 5 years may be eligible for this~     study.~      Volunteers will undergo several tests at their first visit to the clinic for this study. A~     blood sample (about 2/3 of an ounce) will be taken to test for HIV, hepatitis B and C,~     complete blood count, liver functions, blood chemistry and pregnancy in women of childbearing~     age. The blood sample will also be tested for antibodies to Vi, rEPA (the protein of the~     conjugate), and pectin. There will also be a urine collection for testing. If the laboratory~     tests are acceptable, volunteers will be asked to return to the clinic on a...~   "
250217|NCT00277121|"~     Several lipid disorders are without known genetic origin. The scope of this project is to~     sequence genes superior involved in lipid and carbohydrate metabolism in patients with severe~     lipid disorders. The resulting mutations will be tested in suitable in vitro systems to~     detect their part in development of the specific disease.~   "
250218|NCT00277108|"~     The purpose of this study is to determine if Escitalopram (Lexapro) is effective in the~     treatment of postpartum depression.~   "
250219|NCT00277095|"~     The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive~     surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who~     have stress urinary incontinence arising from intrinsic sphincter deficiency following an~     operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two~     adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress~     incontinence.~      The results will be analyzed to demonstrate the effects of the device as well as its~     associated risks. Therapeutic success will be based on whether patients demonstrate at least~     a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at~     baseline.~   "
250220|NCT00277082|"~     To determine the concentration of 9-nitrocamptothecin (9NC) in the alveolar fluid over time.~      1.2. To determine the arterial concentration of 9NC administered by inhalation in comparison~     to venous and urine concentrations.~      1.3. To determine the tumor concentration of 9NC administered by inhalation~   "
250221|NCT00277069|"~     1. Determine the response rate with this regimen in an anthracycline and taxane resistant~     cohort of patients.~   "
250222|NCT00277056|"~     Dysregulated Tyrosine Kinase Signaling in Leukemia~   "
250223|NCT00277043|"~     The purpose of this study are to determine whether a test dose program for taxanes will~     reduce the rate and/or severity of hypersensitivity reactions (HSR); and to determine whether~     a test dose program for taxanes will result in cost reduction due to decreased drug wastage.~   "
250224|NCT00277030|"~     The purpose of this study is to compare two different treatment strategies for RDS in preterm~     infants > 1500 grams and evaluate whether a selective surfactant administration would reduce~     the need of intubation, mechanical ventilation and surfactant use.~   "
250225|NCT00277017|"~     The purpose of this study is to evaluate a therapy combining the established FUNIL regimen~     with Thalidomide. We want to see how well the therapy works, if it can be easily done, and~     how well the body handles the treatment. We also wish to see if the addition of Thalidomide~     will increase the effectiveness of the already established treatment regimen.~   "
250226|NCT00277004|"~     Physiological Biomarkers of Cancer Treatment Related Fatigue in Women with Breast Cancer.~   "
250227|NCT00276991|"~     This research work is important for the cure/control of HIV infection. The objectives of a~     treatment case on HIV patient is essentially to bring down the viral load closer to~     undetectable level. The studies are depend on the potential influence of 'Kallunk Oxide' on~     the CD4+ T cells and the effectiveness on surface of HIV-1. The basic study is to break~     surface protein and directly inhibit a protein's increased functions, not only in the CD4+T~     cell but also CD3 and CD8+ T cells, by appropriate antidote.~      The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and~     lifestyle can be more easily studied.~   "
250228|NCT00276978|"~     20 therapy-refractory patients with major depression will be treated for 3 weeks with~     Aripiprazole 10 mg/d. Effectivity will be assessed using a pre-post comparison of different~     psychopathological rating scales and patient adherence.~   "
250229|NCT00276965|"~     This study will compare the safety and effectiveness of a mood stabilizing medication, an~     antidepressant medication, and a combination of both medications to treat symptoms of bipolar~     type II depression.~   "
250230|NCT00276952|"~     The purpose of this study is to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in~     the treatment of patients diagnosed with chronic tensional-type headache in accordance with~     International Headache Society guidelines~   "
250231|NCT00276939|"~     The purpose of the study is to assess whether, in individuals with type 2 diabetes, a~     low-fat, vegan diet improves blood glucose control more effectively than a control diet based~     on current American Diabetes Association (ADA) guidelines. The principal measure is~     hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The~     study duration is 22 weeks with a one-year follow-up.~   "
250245|NCT00276757|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of Langerhans~     cell histiocytosis, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) may be an effective treatment for Langerhans~     cell histiocytosis.~      PURPOSE: This randomized clinical trial is studying combination chemotherapy to see how well~     it works in treating young patients with Langerhans cell histiocytosis.~   "
250322|NCT00275665|"~     This study is being done in stem cell transplant recipients to see if taking the drug~     valganciclovir can prevent or reduce serious cytomegalovirus (CMV) infections that can occur~     100 days or later after transplant.~   "
250232|NCT00276926|"~     The purpose of this study is to assess the clinical anti-proliferative activity of STI571~     (Glivec®, Novartis, Pharma) in patients with HES defined as:~        1. Idiopathic Hypereosinophilic Syndrome (secondary HES), defined as a peripheral blood~          eosinophilia greater than 1,500 cells/µL for longer than 6 months, absence of other~          apparent aetiologies for eosinophilia and with or without signs and symptoms of organ~          involvement, irrespective to expression of any of imatinib targets (c-Kit receptor,~          PDGFR, bcr-abl receptor) on bone marrow cells.~        2. Familiar hypereosinophilia defined as a peripheral blood eosinophilia greater than 1,500~          cells/µL for longer than 6 months, absence of other apparent aetiologies for~          eosinophilia and signs and symptoms of organ involvement, irrespective to expression of~          any of imatinib targets (c-Kit receptor, PDGFR, bcr-abl receptor) on bone marrow cells,~          and with a recognized or reported cases of hypereosinophilia in the patient's family.~        3. Chronic myeloproliferative disorder, defined as chronic eosinophilic leukemia (CEL) with~          the presence of blasts (>10%) in the bone marrow (BM), or the presence of immature~          eosinophils in different tissues, or an aggressive clinical course or the presence of~          clonal cytogenetic anomalies.~        4. Myeloproliferative disorder (MPD) with eosinophilia, eosinophilic leukemia or chronic~          myelomonocytic leukemia [myeloproliferative disorders/myelodysplastic syndromes~          (MPD/MDS)] with evidence of:~             -  t(5;12)(q33;p13) by cytogenetic or fluorescent in situ hybridization (FISH)~               analysis, or~             -  ETV6/TEL-PDGFRB fusion transcript by reverse transcription polymerase chain~               reaction (RT-PCR), or~             -  PDGFRB disruption, assessed or suspected, by other translocations with additional~               partner genes (H4, HIP1, CEV14 and Rab5) 5, or~             -  MPD/MDS who have constitutive activation of the gene for platelet-derived growth~               factor receptor beta (PDGFRB) 6 by point mutations~   "
250233|NCT00276913|"~     Primary Objectives:~        -  To determine the safety, toxicity and the maximum tolerated dose (MTD) of intravenous~          STA-5312 when administered weekly (3 of 4 weeks) to subjects with advanced or metastatic~          solid tumors.~        -  To determine the pharmacokinetics of STA-5312.~      Secondary Objective:~      • To assess antitumor activity of STA-5312 administration.~   "
250234|NCT00276900|"~     This study will determine the effectiveness of taking sertraline within 24 hours of giving~     birth in preventing a recurrence of postpartum depression.~   "
250235|NCT00276887|"~     This study will examine the long-term effects of cognitive behavioral therapy on the physical~     symptoms, functioning, and health care utilization of people with multiple medically~     unexplained physical symptoms.~   "
250236|NCT00276874|"~     Despite the many behavioral and cognitive treatment therapies that exist for cocaine~     addiction, individuals who complete cocaine abuse treatment are still at high risk for~     relapsing. Aripiprazole, a medication that is currently used to treat schizophrenia, may be~     useful in preventing drug relapse in individuals addicted to cocaine. This three-part study~     will evaluate the interaction between aripiprazole and cocaine. It will also determine the~     safety and effectiveness of aripiprazole in preventing drug relapse among cocaine addicts.~   "
250237|NCT00276861|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent~     colon cancer.~   "
250238|NCT00276848|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. It is not yet known whether giving fludarabine together with~     cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic~     leukemia.~      PURPOSE: This randomized phase III trial is studying giving fludarabine together with~     cyclophosphamide to see how well it works compared to fludarabine alone in treating patients~     with advanced chronic lymphocytic leukemia.~   "
250239|NCT00276835|"~     RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Interleukin-2 may stimulate~     the white blood cells, including natural killer cells, to kill melanoma or kidney cancer~     cells. Giving genistein together with interleukin-2 may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving genistein together with~     interleukin-2 works in treating patients with metastatic melanoma or kidney cancer.~   "
250240|NCT00276822|"~     RATIONALE: An education program based on patients' health communication needs may improve~     patients' overall healthcare experience and sense of control.~      PURPOSE: This clinical trial is studying the health communication needs of patients with~     breast cancer to develop patient education programs.~   "
250241|NCT00276809|"~     RATIONALE: Giving combination chemotherapy before a peripheral blood stem cell transplant~     stops the growth of cancer cells by stopping them from dividing or killing them. Giving~     colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells~     move from the bone marrow to the blood so they can be collected and stored. A monoclonal~     antibody, such as alemtuzumab, is given to kill any remaining cancer cells. Chemotherapy and~     radiation therapy (total-body irradiation) are given to prepare the bone marrow for the stem~     cell transplant. The stem cells are then returned to the patient to replace the blood-forming~     cells that were destroyed by the chemotherapy and radiation therapy. Giving combination~     chemotherapy, total-body irradiation, and alemtuzumab together with autologous peripheral~     stem cell transplant may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with total-body irradiation and alemtuzumab works in treating patients undergoing an~     autologous stem cell transplant for stage I, stage II, stage III, or stage IV chronic~     lymphocytic leukemia.~   "
250242|NCT00276796|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel together with topotecan~     and cisplatin works in treating patients with advanced, persistent, or recurrent cervical~     cancer.~   "
250243|NCT00276783|"~     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating~     patients with recurrent malignant gliomas, primary CNS lymphoma, or brain metastases.~   "
250244|NCT00276770|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography using fluorothymidine~     F 18, may be effective in finding recurrent disease in patients with gliomas.~      PURPOSE: This clinical trial is studying how well positron emission tomography using~     fluorothymidine F 18 works in finding recurrent disease in patients with gliomas.~   "
250281|NCT00276263|"~     The purpose of this study is to determine whether preventative treatment with sarcosine can~     reduce symptoms and delay/avoid disease progression in individuals defined as being in a~     prodromal stage of schizophrenia.~   "
250246|NCT00276744|"~     RATIONALE: Treating tumor tissue in the laboratory with different drugs may help doctors find~     the best drug for treating individual patients with pancreatic cancer.~      PURPOSE: This phase II trial is studying an individualized drug treatment selection process,~     based on laboratory results, for treating patients with pancreatic cancer that can be removed~     by surgery.~   "
250247|NCT00276731|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     radiation therapy after surgery may kill any tumor cells that remain. It is not yet know~     whether combination chemotherapy followed by surgery alone is more effective than combination~     chemotherapy followed by surgery and radiation therapy in treating neuroblastoma.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by~     surgery to see how well it works compared to combination chemotherapy followed by surgery and~     radiation therapy in treating young patients with stage II or stage III neuroblastoma.~   "
250248|NCT00276718|"~     RATIONALE: Drugs used in chemotherapy, such as etoposide, carboplatin, and bleomycin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving combination chemotherapy after~     surgery may kill any tumor cells that remain.~      PURPOSE: This clinical trial is studying how well giving etoposide, carboplatin, and~     bleomycin works in treating young patients undergoing surgery for malignant germ cell tumors.~   "
250249|NCT00276705|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Thalidomide may stop the growth of liver cancer by blocking blood flow to the tumor.~     Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping~     chemotherapy drugs near the tumor. Giving combination chemotherapy, thalidomide, and~     chemoembolization before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed. Giving thalidomide together with chemotherapy after surgery~     may kill any remaining tumor cells and prevent the tumor from coming back.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy and~     thalidomide together with chemoembolization works in treating younger patients undergoing~     surgery for newly diagnosed liver cancer.~   "
250250|NCT00276692|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with~     newly diagnosed Ewing's sarcoma.~   "
250251|NCT00276679|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients~     with high-risk relapsed or refractory neuroblastoma.~   "
250252|NCT00276666|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as lomustine, vincristine, and cisplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving radiation therapy together with combination chemotherapy after surgery may kill any~     tumor cells that remain.~      PURPOSE: This phase II trial is studying giving radiation therapy together with combination~     chemotherapy to see how well it works in treating young patients with metastatic~     medulloblastoma who have undergone surgery.~   "
250253|NCT00276640|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~      PURPOSE: This clinical trial is studying giving radiation therapy or combination chemotherapy~     to see how well it works in treating patients with clinically or radiologically progressive~     low-grade gliomas.~   "
250254|NCT00276627|"~     RATIONALE: A computer program and education materials may help improve the ability of doctors~     to communicate with patients.~      PURPOSE: This randomized clinical trial is studying how well a computer program together with~     education materials works in improving communication between doctors and patients with stage~     IV cancer.~   "
250255|NCT00276614|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with~     metastatic kidney cancer.~   "
250256|NCT00276601|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in~     treating patients with acute promyelocytic leukemia.~   "
250257|NCT00276588|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     carboplatin followed by paclitaxel works in treating patients with stage III or stage IV~     non-small cell lung cancer.~   "
250258|NCT00276575|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Erlotinib and everolimus may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab~     and everolimus may also block blood flow to the tumor. Giving everolimus and erlotinib~     together with bevacizumab may kill more tumor cells.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of~     erlotinib and everolimus when given together with bevacizumab in treating patients with~     advanced solid tumors.~   "
250259|NCT00276549|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel~     works in treating patients with metastatic prostate cancer.~   "
250260|NCT00276536|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth~     of cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in~     treating patients with stage IV solid tumors, lymphoma, or myeloma.~   "
250261|NCT00276523|"~     RATIONALE: SCH 54031 (PEG-interferon alfa-2b) may interfere with the growth of tumor cells~     and slow the growth of head and neck cancer. It may also stop the growth of head and neck~     cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This randomized phase II trial is studying how well different doses of~     PEG-interferon alfa-2b work in treating patients with stage II, stage III, or stage IV head~     and neck cancer that can be removed by surgery.~   "
250262|NCT00276510|"~     The purpose of this study is to determine whether Tanakan® is effective at slowing the~     progression from memory complaint to dementia of Alzheimer's type.~   "
250263|NCT00276497|"~     A three year prospective, double blinded, placebo controlled, randomized clinical trial in~     impaired glucose tolerance (IGT) subjects to study the effect of pioglitazone in preventing~     the conversion to Diabetes.~   "
250264|NCT00276484|"~     To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus~     Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not~     Adequately Controlled on Atorvastatin 40 mg.~   "
250265|NCT00276471|"~     Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to~     evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM~     patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and~     glycemic control.~   "
250266|NCT00276458|"~     The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe~     plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high~     risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.~   "
250267|NCT00276445|"~     Intravenous- injection of beta-1,3-glucan in human is known to induce T helper type 1~     response, while oral uptake did not. It was examined whether superfine dispersed~     beta-1,3-glucan (SDG) contrived to absorbed by intestinal mucosa would alleviate allergic~     symptoms by per-oral ingestion~   "
250268|NCT00276432|"~     The primary outcome in this study will be time to discharge for low-risk patients and~     therapeutic turnaround time for patients with NSTEMI or unstable angina.~   "
250269|NCT00276419|"~     The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo~     (10 weeks of each) for the treatment of noncyclic breast pain.~   "
250270|NCT00276406|"~     Doctors at Mayo Clinic are doing this study to learn if pyridostigmine, a drug, affects the~     speed at which food travels through the stomach, intestines and colon, and if pyridostigmine~     improves constipation symptoms in patients with diabetes. Pyridostigmine has been approved by~     the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed~     in this study is considered investigational.~   "
250271|NCT00276393|"~     Patients with type 1 diabetes trained in multiple daily insulin injection were treated with~     two diffferent kinds of long acting insulin preparations. The two insulin preparations were~     glargine and ultralente insulin. Patients were randomized to receive one of the two insulin~     preparations for the first 4 months followed by the second preparation for a further four~     months. Short acting insulin used was the same during both periods. We found that glargine~     insulin was better than ultralente insulin in our study.~   "
250272|NCT00276380|"~     The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association~     with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following~     ischemic stroke.~   "
250273|NCT00276367|"~     A single post-hospital discharge home visit by a geriatric nurse practitioner or geriatric~     fellow can bridge the gap and ease the transition for elderly frail patients returning home~     after hospital admission. We believe this intervention will reduce medication errors, ensure~     follow-up discharge plans, decrease re-hospitalization rates, and decrease morbidity and~     mortality.~   "
250274|NCT00276354|"~     The main purpose of this study is to evaluate the tolerance of long term repeated doses of~     Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying~     special attention to digestive and nutritional status.~   "
250275|NCT00276341|"~     The purpose of this study is to determine whether the use of EGb 761 by patients with~     Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to~     placebo.~   "
250276|NCT00276328|"~     The purpose of this study is to evaluate whether Smecta® is more effective than placebo with~     respect to time to recovery following an acute diarrhoea episode.~   "
250277|NCT00276315|"~     To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A~     (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of~     hemifacial spasm.~   "
250278|NCT00276302|"~     The primary objectives of the study are:~        -  Determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS~          patients who have failed prior therapies~        -  Recommend a dose for subsequent studies of IPI-504~   "
250279|NCT00276289|"~     Kidney stone formation due to an excess of calcium in the urine is a common problem. It is~     treated with thiazide diuretics. These drugs often cause excessively low blood potassium~     levels that in turn require large doses of potassium supplements. These supplements are often~     large, unpleasant and easy to forget. We are trying the addition of spironolactone to these~     patients' medications to see if it allows them to take a lower dose of potassium.~   "
250280|NCT00276276|"~     The purpose of this study is to find out if giving oral HYCAMTIN to patients with relapsed~     small cell lung cancer benefits them. The study will compare how long patients live when they~     are given therapy to make them feel better (active symptom control) to the length of time~     patients live when they are also receiving oral HYCAMTIN.~   "
250283|NCT00276237|"~     One of the most common residual lesions in adult survivors of pediatric cardiac surgery is~     pulmonary valve disease, particularly regurgitation.~      Multiple studies have demonstrated that placement of a pulmonary valve in such patients,~     results in improved ventricular function and resolution of symptoms. However, the optimal~     prosthetic valve for use in the pulmonary position has not been defined. There are~     essentially three alternatives available: the stented bioprosthetic valve, stentless~     bioprosthetic tube grafts used to replace the entire right ventricular outflow tract and~     mechanical valves.~      All three of these valve options have been used in adults with congenital heart disease at~     Emory Healthcare and at Children's Healthcare of Atlanta at Egleston.~      The goal of this study is to evaluate and compare the indications and short and mid-term~     outcomes for these alternative therapies.~   "
250284|NCT00276224|"~     The objectives of this study is:~        -  to establish the coverage rate of weekly iron supplementation in children in~          intervention schools over a period of nine months~        -  document any side effects of weeekly iron supplementation among children in intervention~          schools over a period of nine months asses the feasibility of incorporating the weekly~          iron supplementation programme into the normal school activity in intervention schools~          determine the extent of acceptability and support for the iron supplementation programme~          by staff at the health centre nearest to the intervention schools~        -  compare the praziquantel efficacy and schistosomiasis reinfection in children in~          intervention schools with that of children in control schools following the introduction~          of weekely iron supplementation over a period of nine months~        -  determine the impact of weekly iron supplementation on haemoglobin levels of children in~          intervention schools and compare with children in control schools over a period of nine~          months~   "
250285|NCT00276211|"~     This study is going to compare diffusionweigthed MRI scanning to the result of surgey in~     patients with metastasis from brestcancer in the axilla~   "
250286|NCT00276198|"~     The objective of the program is to examine the efficacy of 6 month home micronutrient~     supplementation in Bedouin and Jewish children on improvements in nutritional status~     including measures of iron, ferritin, zinc and folic acid, and measures of growth and health~     parameters i.e.reported and recorded morbidity.~   "
250287|NCT00276185|"~     Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This~     study will test if botulinum toxin injections at earlier phases (<or = 3 months) in~     spasticity improve functional and motor tests compared with late injections (>or = 6 months).~   "
250288|NCT00276172|"~     The primary objective of this study is to determine the safety and the immunogenicity of~     extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV)~     to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801,~     C-1802, or C-1803.~   "
250289|NCT00276159|"~     The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat~     certain hematologic malignancies not responding to standard treatment.~   "
250290|NCT00276146|"~     The purpose of this study is to determine the benefits as well as side effects of giving~     drugs called dipyridamole and magnesium to patients with sickle cell anemia (SCA).~   "
250291|NCT00276133|"~     Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular~     injury through conversion to an oxidatively modified form of LDL. However, few studies~     evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective~     actions in hyperlipidemic patients with non-diabetic nephropathy.~   "
250292|NCT00276120|"~     The purpose of this study is to identify novel genetic factors which distinguish breast~     cancer in younger women compared to older women. By identifying these novel genetic factors~     we believe more specific therapies can be developed and breast cancer may be prevented among~     women with an increased cancer risk. A woman does not have to live in St. Louis to~     participate.~   "
250293|NCT00276107|"~     To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age.~     To determine the antibody responses to the seven pneumococcal vaccine serotypes one month~     after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6~     months of age.~   "
250294|NCT00276094|"~     The purpose of this study is to determine whether ospemifene is more effective than placebo~     in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.~   "
250295|NCT00276081|"~     To compare the efficacy and safety of gabapentin, estrogen and placebo in the treatment of~     hot flashes and other climacteric symptoms.~   "
250296|NCT00276068|"~     The Vulvar Vestibulitis Clinical Trial (VVCT) a randomized, placebo-controlled, double~     blinded clinical trial. We will study the clinical efficacy of four medical treatments for~     vulvar vestibulitis: topical lidocaine, oral desipramine, combined lidocaine and desipramine,~     and placebo cream and capsules. Desipramine is a tricyclic antidepressant commonly used by~     clinicians for treatment of several chronic pain conditions that demonstrates an optimal side~     effect profile compared to other tricyclic antidepressants. Topical lidocaine has also been~     found to be beneficial for vulvar vestibulitis treatment in small studies. It is hypothesized~     that the combined use of oral desipramine and topical lidocaine will be more therapeutically~     effective than either one by itself and better than placebo.~   "
250297|NCT00276055|"~     1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed~     dose of docetaxel and bevacizumab.~      1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab~     in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination~     of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma~   "
250298|NCT00276042|"~     The study will be conducted in infants and children with acute otitis media, 6 months to less~     than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to~     describe bacteriologic efficacy in those with initial culture positive specimens with~     different dosages of faropenem~   "
250299|NCT00276029|"~     The purpose of this study was to investigate whether the administration of etanercept to~     patients with severe asthma improved their asthma related quality of life and a measure of~     the degree of reactivity of the airways~   "
250323|NCT00275652|"~     This trial is being done to see if the investigational drug, LdT (Telbivudine), is safe and~     effective in the treatment of hepatitis B infection. In addition to this, we will be looking~     at the comparison of the effects (good and bad) of LdT and lamivudine.~   "
250300|NCT00276016|"~     This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover~     study, conducted at a single site in Austria, outside of the normal grass pollen season. An~     allergic reaction will be induced by exposing subjects to grass pollen in the Vienna~     Challenge Chamber (VCC). Subjects will receive a single dose of each of the following~     treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release~     capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a~     minimum of a 5-day washout period between each treatment. Subjects will complete symptom~     evaluations throughout the study. The nasal decongestant effects of phenylephrine will be~     compared to those of placebo using the subjective symptom evaluations. The safety profile~     (adverse events and vital signs) of the treatments will also be evaluated.~   "
250301|NCT00276003|"~     Primary objectives~        -  Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins~          disease, treated with the combination of the gemcitabine and irinotecan.~      Secondary objectives~        -  Assess progression free survival in these patients treated with this regimen.~        -  Assess toxicity of this regimen in this group of patients.~   "
250302|NCT00275990|"~     The purpose of this study is to determine whether prompt removal of thrombus (blood clot)~     from a blocked coronary artery using the AngioJet rheolytic thrombectomy device will result~     in improved blood flow within the heart and a smaller final infarct size (reduced injury to~     the heart muscle).~   "
250303|NCT00275977|"~     The aim of the study is to investigate whether infusion of autologous bone marrow derived~     stem cells can improve cardiac function in the aftermath of a myocardial infarction.~   "
250304|NCT00275964|"~     Context:Clinical trials demonstrating increased risk of cardiovascular disease and breast~     cancer among women randomized to hormone replacement therapy have attracted people's focus on~     the alternative therapy for menopausal symptoms. This study drug- a mixture of~     CHIA-WEI-HSIAO-YAO-SAN, CHIH-PO-TI-HUANG-WAN, HSIANG-SHA-LIU-CHUN-TZU-TANG (TMN1) is widely~     used as an alternative to hormonal therapies for hot flush in Taiwan. However, there is a~     paucity of data supporting their efficacy and safety.~      Objective:To evaluate the safety and efficacy of TMN1 in the treatment of hot flush.~      Design and Setting:A multi-center, prospective, observational follow-up study was conducted~     from July 2003 to December 2004 in 4 hospitals.~      Participants:In total, 136 eligible subjects entered this study. They were required to take~     study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up~     efficacy and safety evaluations.~      Main Outcome Measures:During the observation period, the investigators and study nurses~     actively enquired subjects if there was any adverse event (AEs) occurring to them by using~     Traditional Chinese medicine Adverse Events (TCM AE) questionnaire which includes 20 AEs~     proposed by experienced CM doctors as most commonly seen in the use of study drug. Every~     subject's complaint or abnormal laboratory value were carefully examined for possible~     causality and reviewed and decided by the research team. The primary outcome measure was the~     mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of~     menopausal symptoms measured by the Kupperman Menopause Index. The secondary outcome measures~     included changes in quality of life measured by World Health Organization Quality of Life~     (WHOQOL) questionnaire, and adverse events monitored actively by a global assessment of~     tolerability. During the study period, every subject also received tests on routine~     hematology, biochemical function, and gynecologically relevant hormones at baseline visit, 4~     weeks and 12 weeks after medication.~   "
250305|NCT00275951|"~     The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL~     may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.~   "
250306|NCT00275938|"~     Hepatitis B virus (HBV) causes a wide spectrum of liver diseases, such as fulminant or acute~     hepatitis, chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. The number of~     individuals infected with this virus has been estimated to be as high as 350 million. Thus,~     in addition to global hepatitis B vaccination, effective treatment of chronic hepatitis B is~     also needed.~      Currently, there are no effective antiviral treatments to cure HBV infection in patients with~     chronic hepatitis B. Five drugs have been approved for the treatment of chronic hepatitis B~     at present: conventional interferon (IFN) alpha, lamivudine, adefovir dipivoxil, pegylated~     IFN alpha and recently entecavir. Overall, satisfactory virologic and serologic responses~     could be achieved using pegylated IFN alpha alone in around 20-44% of these patients.~     Nevertheless, better treatment options are still needed for the remaining >50%~     non-responders.~      Although the best treatment choice for chronic hepatitis B is not clarified yet, certain~     therapeutic concepts could be derived from the experience of treating patients with chronic~     hepatitis C. A major advancement in treating hepatitis C virus (HCV) infection has been the~     development of combination therapy with IFN and ribavirin. IFN monotherapy is limited by poor~     sustained virologic responses, even when higher doses of IFN are used. IFN plus ribavirin~     combination therapy, in contrast, results in much improved treatment outcomes. In our~     previous study and others, sustained remission rate after cessation of therapy were~     significantly higher in patients receiving combination therapy than those receiving IFN~     alone. Therefore, combination therapy with IFN and ribavirin has been recommended as the~     standard treatment regimen for chronic hepatitis C. Furthermore, we have used ribavirin and~     IFN combination for the treatment of dual chronic hepatitis B and C, and the results also~     revealed that the efficacy of clearing HCV RNA was not affected by the presence of HBV~     infection. Interestingly, after a little more than 2-year post-treatment follow-up, we found~     that a significant portion (21%) of the responsive patients also cleared HBsAg. These~     findings imply that this combination regimen might be also effective for the control of~     chronic hepatitis B. We thus conducted a randomized, multi-center, placebo-controlled study~     in patients with HBeAg-positive chronic hepatitis B.~   "
250307|NCT00275925|"~     This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine~     monotherapy in adults with partial seizures.~   "
250308|NCT00275912|"~     This study is aimed to collect additional data regarding the efficacy in reducing the~     frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine~     monotherapy in children.~   "
250309|NCT00275899|"~     Decoy receptor 3 (DcR3), a new member of tumor necrosis factor receptor (TNFR) superfamily,~     is a decoy receptor for FasL and could inhibit FasL-induced apoptosis, has recently been~     shown to induce costimulation of T cells. Systemic lupus erythematosus (SLE) is an autoimmune~     disease with pathogenic autoantibodies and immune complexes results from abnormal immune~     responses including T and B lymphocyte hyperactivity, and formation of pathogenic subsets of~     autoantibodies. Rhematoid arthritis (RA) is a multi-systemic autoimmune disease characterized~     by persistent inflammatory synovitis. Activated T lymphocytes infiltration to synovium is~     strongly correlated with the symptoms. DcR3 mRNA is expressed in peripheral-blood T cells and~     is up-regulated after antigenic stimulation. The DcR3 gene has been demonstrated to be~     overexpressed in patients with sclerosis or SLE; however, role of DcR3 in SLE and RA as well~     as the effects of DcR3 on T cell immune response is still not clear. This study is to~     investigate role of DcR3-induced T cell activation in SLE and RA. The genetic polymorphisms~     of DcR3 in association with SLE and RA will be studied to elucidate the genetic factors~     associated with development of SLE and RA. For further explore the possible molecular~     mechanisms of elevated DcR3 in association with SLE, we attempt to study whether DcR3 could~     induce T cell activation via costimualtion and/or inhibit the activation induced cell death~     (AICD) of activated T cells in SLE and RA. This study will provide a new direction of therapy~     in reverse T cell hyper-reactivity in SLE and RA.~   "
250324|NCT00275639|"~     This research study is being done to study the effects, both good and bad, of calcineurin~     inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a~     liver transplant.~   "
250310|NCT00275886|"~     Helicobacter pylori is a major human pathogen that infects over half of the world population.~     Infection initiates a series of changes in the gastric mucosa, beginning with gastritis and~     leading in some patients to peptic ulcer disease, mucosa-associated lymphomas, and gastric~     adenocarcinoma. It is believed that host factors, in particular, the T cell-mediated immune~     responses may play an important role in the pathogenesis of diseases induced by H. pylori~     infection. Recent results revealed that there were higher IFN-γ secreting cells in gastric~     infiltrating T cells isolated from H. pylori infected patients than in uninfected patients,~     suggesting that the TH1 response and degree of IFN-γ production is associated with disease~     severity. Meanwhile, recent studies have shown that apoptosis of the gastric epithelium is~     increased during infection and this response is associated with an expansion of gastric~     T-helper type 1 (Th1) cells. In this project, we are trying to further investigate role of~     host T cell mediated immune response in pathogenesis of Helicobacter infection by~     characterization of the expression of chemokine receptors on gastric infiltrating~     lymphocytes. We are going to investigate the mechanisms involving in chemokine/chemokine~     receptor interaction in recruitment of gastric infiltrating lymphocytes and pathogenesis of~     gastric mucosa damage in Helicobacter infection. This study will be helpful for understanding~     the mechanisms of activation and recruitment of gastric-infiltrating lymphocytes during~     gastric inflammation.~   "
250311|NCT00275834|"~     The primary aim of this study is to assess long-term weight loss efficacy of zonisamide~     relative to placebo in obese patients prescribed a dietary intervention.~   "
250312|NCT00275821|"~     The study will test if the efficacy and safety of an alternative dosing regimen is as~     effective as monthly injections.~   "
250313|NCT00275795|"~     Food allergy reactions cause various health disorders in sensitive people. These reactions~     may be IgE-mediated,cell-mediated, energy disturbance-mediated, or a combination of the~     three. Certain laboratory diagnostic procedures have been able to identify most IgE-mediated~     or cell-mediated food reactions, but so far there is no test available in traditional~     medicine to test the energy-mediated allergies and sensitivities. NAET® procedures have been~     able to identify food substances triggering to energ disturbances in sensitive people causing~     related health disorders. NAET uses one of the testing procedures called NST (Neuromuscular~     sensitivity testing).The efficacy of NST-NAET to screen food sensitivity will be evaluated in~     comparison with one of the well accepted, established, traditional medicine allergy testing~     known as the IgE-specific antigen test.~   "
250314|NCT00275769|"~     This study compares the pacemaker's automatic pacing threshold measurements to the manual~     measurements conducted by a health care provider.~   "
250315|NCT00275756|"~     Background~      Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in~     perfusion pressure. The existence of an effective autoregulation in the optic nerve~     circulation has been shown in animals and humans. The exact mechanism behind this~     autoregulation is still unknown. The motive for the investigation of optic nerve head (ONH)~     blood flow autoregulation is to enhance the understanding of pathologic eye conditions~     associated with ocular vascular disorders. To clarify the regulatory mechanisms of ONH~     microcirculation is of critical importance to understand the pathophysiology of glaucoma,~     because there is evidence that glaucoma is associated with optic nerve head ischemia. Several~     studies indicate that a disturbed autoregulation might contribute to glaucomatous optic~     neuropathy. Currently, five classes of intraocular pressure (IOP) reducing drugs are~     available for topical therapy in patients with glaucoma or elevated intraocular pressure.~     These drugs have also vasoactive properties, which may influence both the resting ocular~     circulation and the autoregulatory mechanisms of blood flow during changes in ocular~     perfusion pressure.~      Study objective~      To investigate the influence of common topical glaucoma therapy on ONH blood flow regulation~     during changes in IOP and systemic arterial blood pressure.~   "
250316|NCT00275743|"~     This study is being done to test new way of measuring the relaxation of the stomach after a~     meal (called gastric accommodation) by using a MRI scan. This new test will be compared with~     the standard test of measuring stomach relaxation that uses radioactive tracers. These tests~     will be compared in healthy volunteers and people with upper abdominal symptoms (known as~     dyspepsia).~   "
250317|NCT00275730|"~     Prostaglandins (PG) are known to alter regional ocular blood flow and exhibit vasoactive~     properties in isolated ocular blood vessels. A variety of animal experiments indicate that~     endogenous PGs play a role in the regulation of retinal (RBF) and choroidal (ChBF) blood~     flow. There is also evidence that the prostaglandin pathway is involved in the activation of~     NO production in humans, however, the mechanisms for interactions between PG and NO in ocular~     vasculature are still unclear.~      Animal studies suggest that retinal and choroidal blood flow decrease after administration of~     indomethacin (a nonspecific cyclooxygenase inhibitor). More recently, it has been shown that~     indomethacin injected intravenously decreased optic nerve oxygen tension and reduced the CO2~     reactivity. This is probably the result of decreased blood flow through vasoconstriction of~     vessels in the optic nerve. Systemic administration of indomethacin also diminishes cerebral,~     renal and mesenteric blood flow by an unknown mechanism. However, no clinical trials exist so~     far investigating the effects of indomethacin on ocular blood flow. Therefore, the aim of~     this study is to investigate the effect of indomethacin on ocular blood flow in healthy~     humans.~   "
250318|NCT00275717|"~     This study is being done to collect blood and bone marrow samples for biologic studies of~     antibody producing cells. Donor specific antibodies can cause damage to the kidneys after~     they are transplanted. The study will look at the impact of immunosuppression on antibody~     production by antibody producing cells.~   "
250319|NCT00275704|"~     Flaxseed, a phytoestrogen, is a natural food supplement rich in plant ligands, which have a~     very weak estrogen effect. In this study, flaxseed is being evaluated in regard to its~     capacity to safely and effectively treat hot flashes. Specifically, this study seeks to~     determine if flaxseed will lower the number and severity of hot flashes and if women~     experience any side effects from taking flaxseed for this purpose.~   "
250320|NCT00275691|"~     Community acquired pneumonia(CAP) is a common cause of morbidity and mortality. The diagnosis~     of CAP from the microbiology perspective has been challenging. Recent reports suggest the~     utility of real-time PCR for rapid and accurate diagnoses of these pathogens. Real-Time PCR~     tests, using the LightCycler instrument, will be performed on excess or additional specimens~     after extraction of nucleic acid.~   "
250325|NCT00275613|"~     Membranoproliferative glomerulonephritis (MPGN) is a relatively-rare, immune-mediated kidney~     disease. All current therapies are inadequate and MPGN frequently leads to kidney failure.~     This study is a 10 patient trial of the monoclonal antibody rituximab for adult patients with~     MPGN. Study patients will receive 2 doses of rituximab intravenously on days 1 and 15 and~     will then be followed for 1 year.~   "
250326|NCT00275600|"~     This study is being done to find out what effects Vitamin E or Evening Oil of Primrose has on~     cyclical breast pain.~   "
250327|NCT00275587|"~     Our broad, long-term objective is to create a new non-resident (non-teaching) hospital~     service that uses patient-centered critical pathway care plans for treating patients in St.~     Marys Hospital. This innovative service, the Hospital Medicine (HOME) Team, will integrate~     three timely, high-priority concepts in healthcare: patient-centered quality care,~     evidence-based medicine, and principles that define high reliability organizations. The~     target populations for the new model of service are patients hospitalized with pre-defined~     admission diagnoses who are expected to require only a brief, focused hospital stay of four~     days or less. Specifically, we will 1) Design the prototypical approach to be used for~     developing all critical pathway care plans by integrating patient-centered quality care,~     evidence-based medicine, and principles that define high reliability organizations, 2)~     Systematically design the critical pathway care plans for two pre-defined admission diagnoses~     (community-acquired pneumonia and non-surgical low-back pain), and 3) Compare outcomes of~     this new service against respective historical patient cohorts for patients admitted with~     community-acquired pneumonia and non-surgical low-back pain. We anticipate that the~     prototypic methodology used to develop this patient-centered service will be replicated for~     other new hospital-service models. To our knowledge, there are currently no existing hospital~     services in the U.S. that have intentionally integrated principles of high reliability~     organizations into evidence-based critical pathways founded on patient-centered principles of~     uncompromising quality.~   "
250328|NCT00275574|"~     Breast pain or mastalgia is a common and troublesome symptom for many women. Whereas cyclical~     breast pain related to hormonal fluctuations can frequently be treated, non-cyclical breast~     pain can go untreated due to its various etiologies and non-specific presentation.~     Acupuncture is an ancient form of Chinese medicine that has been used for centuries to treat~     a vast array of illnesses and conditions. Research has shown that acupuncture has a link to a~     release of endorphins and other chemicals in the central nervous system. Thus, it is thought~     to help relieve pain. To date, there has been minimal research using acupuncture for breast~     pain. This pilot of 30 women will seek to determine whether four acupuncture treatments over~     a period of two weeks will significantly lower the level of pain experienced by these~     participants. Additionally, we will evaluate quality of life measures.~   "
250329|NCT00275561|"~     This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic~     esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the~     esophagus becomes filled with large numbers of eosinophils, a type of white blood cell.~     Patients who have this condition have difficulty in swallowing (dysphagia) solid food.~      Prior to treatment the patients had biopsies of their esophagus and took questionnaires~     regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken~     from the esophagus to measure any changes in the tissue from before treatment. The primary~     endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia~     Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue)~     response to treatment.~   "
250330|NCT00275548|"~     The study is being done to study the impact of prophylactic administration of antiviral~     therapy as compared to initiation of antiviral therapy at the time of clinical recurrence of~     hepatitis C infection in liver transplant recipients.~   "
250331|NCT00275535|"~     This study was done to find out which treatment, tacrolimus or sirolimus, leads to better~     long-term kidney function in kidney transplant patients.~   "
250332|NCT00275522|"~     The study is being done to compare the safety and effects (good and bad) of three different~     combinations of immunosuppression drugs used by kidney transplant recipients while also~     looking at their kidney function.~   "
250333|NCT00275509|"~     The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is~     a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney~     transplant recipients who have a positive crossmatch with their live donor.~   "
250334|NCT00275496|"~     Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their~     melanoma. If the melanoma meets study requirements, the subject is randomized to receive~     either (1) no further surgical procedures as part of the study or (2) a Selective~     Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then~     followed for 10 years.~   "
250335|NCT00275483|"~     The purpose of this study is to determine whether stimulation to the akupressurpoint P6 with~     a recently developed bracelet are effective preventing postoperative nausea and vomiting~   "
250336|NCT00275457|"~     To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from~     moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week~     open label or double blind extension.~   "
250337|NCT00275444|"~     A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose~     ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple~     antiretroviral experienced patients and the dose that achieves the best efficacy and safety~     as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and~     laboratory profile measures would be selected for further clinical study.~   "
250338|NCT00275431|"~     This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of~     single-agent AT-101 in patients with relapsed or refractory B-cell malignancies.~   "
250339|NCT00275418|"~     Many inflammatory disorders in the body are linked to oxidative tissue damage. Anti-oxidants~     that are present in many natural food sources may provide protection from such damage.~      Beta carotene is an anti-oxidant vitamin present in many fruits and vegetables. The algae~     Dunaliella is particularly rich in beta carotene.~      In this prospective trial we want to investigate whether beta carotene from Dunaliella may~     prevent exacerbations of Crohn's disease.~   "
250340|NCT00275405|"~     This research will investigate the effect of garlic oil extract when added to daily diet on~     inflammatory mediators and blood clotting activation.~   "
250341|NCT00275392|"~     The purpose of this study is to develop effective exercise intervention to reduce dizziness~     and fall risk in older adults with non-specific dizziness. We hypothesize that the use of~     vestibular exercises can reduce dizziness and improve gaze and postural stability in older~     persons.~   "
250342|NCT00275379|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design,~     exploratory study of orally administered ERB-041 in subjects with active IC. The primary~     objectives of this study will be to investigate ERB-041’s activity on levels of urinary APF,~     explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to~     evaluate the safety of ERB-041 in women with active IC.~   "
250343|NCT00275366|"~     This purpose of this study is to determine the outcomes of the first-known application of~     robotic therapy in the rehabilitation following rotator cuff repair, using a novel vertical~     oblique robotic module.~   "
250344|NCT00275353|"~     The purpose of this study is to examine whether an Individualized Symptom Education Program~     (ISEP) is helpful to women to manage their symptoms when they are receiving radiation therapy~     for gynecological cancer.~      It is expected that women who participate in the ISEP program will be better able to manage~     their symptoms and exprience less distress than women who receive usual care.~   "
250345|NCT00275340|"~     Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who~     are older and sicker than in previous years. Increased patient acuity and reduced hospital~     length of stays leave individuals ill prepared for their recovery following discharge.~     Individuals experience pain, functional impairment and depressive symptoms following~     discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional~     decline and depressive symptoms predispose individuals to adverse events, impaired~     health-related quality of life (HRQOL), and increased morbidity and mortality.~      Existing supports; including printed education materials, community care resources, cardiac~     rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of~     individuals in this early period following hospital discharge.~      Despite the positive health outcomes in other patient populations, valid studies examining~     the impact of telephone-based peer support to men and women after hospital discharge from~     CABG surgery were not found. It is anticipated that a home-based peer support program,~     delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early~     weeks post hospital discharge from CABG surgery.~   "
250346|NCT00275327|"~     o determine if extended-spectrum beta-lactamases, plasmid-mediated AmpC beta-lactamases,~     carbapenemases, chromosomal mutations in ribosomal RNA or other mechanisms of resistance~     account for antibiotic resistance in commonly encountered Gram negative and Gram positive~     bacteria at UPMC. Also to determine the molecular epidemiology and in vitro susceptibility of~     multiply resistant organisms at UPMC and to relate this to antibiotic use in the institution.~   "
250347|NCT00275314|"~     This is a multi-center, open label, randomized, 3-way cross-over study. 21 subjects will be~     randomized to receive all three treatments in one of three treatment sequences.~      Patients at risk of CMV disease (D+R-, D+R+, D-R+), who are being treated prophylactically~     with Valcyte® (commercially available tablets), after their first or second kidney transplant~     and who have adequate renal and hematological function will be eligible for the study.~     Screening may be at any time after transplantation provided that follow-up procedures can be~     completed during the scheduled time of prophylaxis. The first dose of study drug may be~     between 1 and 14 days after screening provided the transplant has stabilized, stable serum~     creatinine and steady-state kinetics of ganciclovir and calcineurin inhibitor therapy have~     been attained. Follow-up will take place 7- 14 days after last dose of study drug~     administration; therefore the duration of the study will be up to 5 weeks.~   "
250348|NCT00275301|"~     The overall design of the study is to perform both a PET and MRI scan on objectively~     identified borderline personality disorder patients, to treat them with olanzapine for 8~     weeks, and to then re-scan the patients with PET.~   "
250349|NCT00275288|"~     MRI Study for females ages 18-45 with Borderline Personality Disorder(BPD): This study is a~     non-treatment study that involves 2 visits. Study Hypothesis:~        1. To refine and pilot test functional neuroimaging paradigms to assess the amygdala~          response to neutral facial expressions across positive and negative emotional contexts.~        2. To assess whether patients with borderline personality disorder show a heightened~          amygdala response to neutral facial expressions relative to healthy controls (20 female~          healthy controls, 20 females with borderline personality disorder).~        3. To assess the relationship between individual differences in clinical ratings of~          personality and affective regulation, and the amygdala response to facial expressions.~   "
250350|NCT00275275|"~     A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in~     patients with Parkinson's disease to determine the appropriate conversion ratio and side~     effects related to the drug.~   "
250351|NCT00275262|"~     Phase 2 study, conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple~     myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell~     transplantation.~   "
250352|NCT00275249|"~     The purpose of this study is to determine the extent to which analgesic tolerance develops in~     chronic pain patients who are either started on opioids or who receive an increase in~     pre-study opioid dose level and then observed during long-term (20 weeks) stable opioid~     therapy. In addition to clinical measures of relief of ongoing chronic pain, estimation of~     tolerance development will be supplemented by periodic assessment of the anti-nociceptive~     effects of opioids using the brief thermal sensitization model.~   "
250353|NCT00275236|"~     The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in~     subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total~     time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of~     PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained~     from PSGs.~   "
250403|NCT00274586|"~     Tolerability of a four weeks treatment with Aggrenox® modified release capsules b.i.d,~     compared to reduced dose during the first two weeks of treatment in a double-blind,~     randomized controlled parallel group comparison trial among Taiwanese patients with previous~     TIA's or ischemic stroke.To monitor frequency and intensity of headaches and other safety~     parameters among Taiwanese patients with previous TIA's or ischemic stroke given Aggrenox~     using a titration scheme or not~   "
250354|NCT00275223|"~     This study aims to understand the biological processes that link obesity to diseases~     including insulin resistance and diabetes. Our approach involves studying the health of~     patient undergoing weight loss either via weight reduction surgery or by medically supervised~     liquid formula diets. Patients must be enrolled in a weight treatment program at Emory~     Bariatrics, Emory University, Atlanta GA, to be eligible for this study. This study does not~     cover the cost of treatment at Emory Bariatrics. The hypothesis is that decreases in~     adipose-tissue derived factors during weight loss will be related to improvement in insulin~     function.~   "
250355|NCT00275210|"~     To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III~     colon cancer.~      Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS),~     safety (including long term toxicity)~   "
250356|NCT00275197|"~     The major purpose of the study is to help determine whether giving the combination of~     Elzasonan with Zoloft to people with depression is a better treatment than taking Zoloft~     alone. This study will also compare the safety and tolerability of Elzasonan and Zoloft~     combination to Zoloft alone or placebo.~   "
250357|NCT00275184|"~     The aim of this study is to determine whether taking bowel preparation (citramag and senna)~     or a medicine to speed up transit through the stomach (metoclopramide), will improve the~     quality of the images seen, increase the transit through the small bowel, and increase the~     rate of completion of capsule endoscopy.~      The secondary objective is to determine whether patients could routinely tolerate this bowel~     preparation prior to capsule endoscopy and whether the diagnostic yield of capsule endoscopy~     is improved.~   "
250358|NCT00275171|"~     The study aims at clarifying (in a randomized, double-blinded design):~        1. Whether stimulation with 0.1 mg rhTSH 24, 48 or 72 hours before induction of a~          131I-tracer dosis increases the 131I uptake in patients with atoxic multinodular goitre~          and to study which time interval is the most optimal (Part I)~        2. Whether patients suffering from atoxic multinodular goitre obtains a corresponding~          goitre reduction compared with a control group when stimulating with 0.1 mg rh TSH 24,~          48 or 72 hours before 131I therapy and when reducing the thyroid radiation dose to 50 Gy~          (Part II)~      The two studies will be carried out successively on the same patient population. The 131I~     uptake will be carried out first followed by the I therapy itself. The patients are compared~     with a placebo-treated control group going through the same course of treatment, but the 131I~     dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed~     during one year with a regular ultrasound scan of the thyroid gland and control of the~     metabolic status. The patient satisfaction is monitored by the use of a~     visual-analogue-scale.~   "
250359|NCT00275158|"~     Pre-eclampsia complicates 7 - 10% of pregnancies and constitutes a leading cause of fetal~     growth retardation and premature birth, as well as infant and maternal morbidity and~     mortality. The kidney is the primary site of injury resulting in high blood pressure, loss of~     protein into the urine and decreased kidney function. The release of vasoconstrictors over~     vasodilators from an abnormal placenta may underlie pre-eclampsia. Nitric Oxide (NO) is an~     important vasodilator that is thought to play an important role in the kidneys ability to~     accommodate to a healthy pregnancy. Normal pregnancy in the rat is accompanied by increased~     production of NO and its second messenger cGMP. There is a parallel increase in renal~     expression of constitutive nitric oxide synthase (NOS), the enzyme that generates NO from~     arginine. In the pregnant rat, an infusion of NG-nitro-L-arginine methyl ester (L-NAME), an~     exogenous inhibitor of NOS, has been shown to replicate some of the hemodynamic features of~     the syndrome of pre-eclampsia. In a recent animal study, L-arginine supplementation reversed~     the adverse effects of L-NAME on pregnancy by attenuating the high blood pressure and by~     significantly decreasing protein loss in the urine. To date, studies of the use of L-arginine~     supplementation to treat women with pre-eclampsia have been small or uncontrolled and have~     only assessed blood pressure as a primary outcome measure. We report a single center,~     randomized, placebo-controlled trial of L-arginine supplementation for the treatment of~     pre-eclampsia, in which precise physiological techniques have been utilized to assess kidney~     dysfunction in addition to blood pressure.~   "
250360|NCT00275145|"~     This study will investigate the separate and combined effects of aerobic and resistance~     training on cardiovascular risk factors in overweight men and women with mild to moderate~     dyslipidemia.~   "
250361|NCT00275132|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether erlotinib is more effective than a~     placebo in treating non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works~     compared to a placebo in treating patients with stage III or stage IV non-small cell lung~     cancer.~   "
250362|NCT00275119|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating~     patients with locally advanced pancreatic cancer that cannot be removed by surgery.~   "
250363|NCT00275106|"~     RATIONALE: Drugs used in chemotherapy, such as prednisolone and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer~     cells. It is not yet known whether prednisolone is more effective than dexamethasone when~     given together with combination chemotherapy in treating lymphoblastic lymphoma.~      PURPOSE: This phase III randomized clinical trial is studying prednisolone to see how well it~     works compared to dexamethasone when given together with combination chemotherapy in treating~     young patients with newly diagnosed lymphoblastic lymphoma.~   "
250364|NCT00275093|"~     This phase I trial is studying the side effects and best dose of temsirolimus in treating~     patients with metastatic solid tumor or lymphoma that cannot be removed by surgery who have~     different levels of liver function. Temsirolimus may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Temsirolimus may have different effects~     in patients who have changes in their liver function~   "
250365|NCT00275080|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with decitabine in treating patients with advanced solid tumors or relapsed or~     refractory non-Hodgkin's lymphoma, acute myeloid leukemia, acute lymphocytic leukemia, or~     chronic myelogenous leukemia.~      Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving vorinostat together with decitabine may kill more cancer cells.~   "
250366|NCT00275067|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     arsenic trioxide and temozolomide together with radiation therapy after surgery may kill any~     remaining tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide~     and temozolomide when given together with radiation therapy and to see how well they work in~     treating patients with malignant glioma that has been removed by surgery.~   "
250367|NCT00275054|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others~     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,~     such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Sometimes the cancer~     may not need treatment until it progresses. In this case, observation may be sufficient. It~     is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is~     more effective than observation alone in treating chronic lymphocytic leukemia.~      PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and~     cyclophosphamide to see how well they work compared to observation alone in treating patients~     with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.~   "
250368|NCT00275041|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving irinotecan together with cetuximab may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with cetuximab~     works in treating patients with metastatic breast cancer.~   "
250369|NCT00275028|"~     This phase II trial is studying how well AZD2171 works in treating patients with recurrent~     ovarian, peritoneal, or fallopian tube cancer. AZD2171 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor~   "
250370|NCT00275015|"~     RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of~     cancer cells by stopping them from dividing or killing them. Giving colony-stimulating~     factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone~     marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is~     then given to prepare the bone marrow for the stem cell transplant. The stem cells are then~     returned to the patient to replace the blood-forming cells that were destroyed by the~     chemotherapy and radiation therapy.~      PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with~     total-body irradiation works in treating patients who are undergoing an peripheral stem cell~     transplant for chronic lymphocytic leukemia.~   "
250371|NCT00275002|"~     This phase II trial is studying how well giving O6-benzylguanine together with temozolomide~     works in treating young patients with recurrent or progressive gliomas or brain stem tumors.~     Drugs used in chemotherapy, such as O6-benzylguanine and temozolomide , work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. O6-benzylguanine may help temozolomide work better by making tumor cells more~     sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more~     tumor cells.~   "
250372|NCT00274989|"~     CLL2M is a phase 2, multicenter, open label study to investigate the possible therapeutic~     benefits of using bendamustine in combination with rituximab for the treatment of patients~     with previously untreated or relapsed CLL.~   "
250373|NCT00274976|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them.~      PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in~     treating patients with advanced chronic lymphocytic leukemia that did not respond to previous~     fludarabine.~   "
250374|NCT00274963|"~     RATIONALE: Drugs used in chemotherapy, such as bendamustine and mitoxantrone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer~     cells.~      PURPOSE: This phase II trial is studying how well giving bendamustine together with~     mitoxantrone works in treating patients with relapsed or refractory B-cell chronic~     lymphocytic leukemia.~   "
250375|NCT00274950|"~     RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it~     progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells.~      PURPOSE: This phase III trial is studying how well observation and/or combination~     chemotherapy works after surgery or biopsy in treating young patients with extracranial germ~     cell tumors.~   "
250376|NCT00274937|"~     This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy~     work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal~     cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as~     cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving radiation therapy together~     with amifostine and chemotherapy may kill more tumor cells.~   "
250377|NCT00274924|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving rituximab together with combination chemotherapy may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large~     B-cell non-Hodgkin's lymphoma.~   "
250378|NCT00274911|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as lomustine, cisplatin, and vincristine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving radiation therapy followed by combination chemotherapy after surgery may kill any~     remaining tumor cells.~      PURPOSE: This phase II trial is studying how well giving radiation therapy followed by~     combination chemotherapy works in treating young patients with supratentorial primitive~     neuroectodermal tumors.~   "
250379|NCT00274898|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after~     radiation therapy and chemotherapy may kill any tumor cells that remain after radiation~     therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may~     not need additional treatment until it progresses. In this case, observation may be~     sufficient.~      PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works~     compared to observation in treating patients who have undergone radiation therapy and~     chemotherapy for stage II or stage III non-small cell lung cancer.~   "
250380|NCT00274885|"~     RATIONALE: Learning about the relationship between platinum levels in the blood and~     neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients~     live more comfortably.~      PURPOSE: This phase IV trial is studying the relationship between platinum levels in the~     blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal~     cancer.~   "
250381|NCT00274872|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. It is not yet known which combination chemotherapy regimen is more~     effective in treating colorectal cancer.~      PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens~     to compare how well they work in treating patients with metastatic colorectal cancer that~     cannot be removed by surgery.~   "
250382|NCT00274859|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     oxaliplatin works in treating patients with metastatic cancer who cannot receive~     anthracycline or taxane therapy.~   "
250383|NCT00274846|"~     RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps~     stop the growth of cancer cells. It also helps stop the patient's immune system from~     rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets.~      PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK~     cells from a donor works in treating patients with relapsed acute myeloid leukemia.~   "
250384|NCT00274833|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation~     therapy together with temozolomide and erlotinib after surgery may kill any remaining tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving radiation therapy together with~     temozolomide and erlotinib works in treating patients with newly diagnosed glioblastoma~     multiforme.~   "
250385|NCT00274820|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of~     cancer cells. The cancer is said to be resistant to chemotherapy. Giving ascorbic acid may~     reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the~     growth of cancer cells by blocking blood flow to the cancer. Giving arsenic trioxide together~     with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with~     ascorbic acid, dexamethasone, and thalidomide works in treating patients with chronic~     idiopathic myelofibrosis or myelodysplastic or myeloproliferative disorders.~   "
250386|NCT00274807|"~     RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more cancer cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     patients with newly diagnosed acute myeloid leukemia.~   "
250404|NCT00274573|"~     The primary objective of this study is to investigate the effect of tiotropium vs. placebo on~     trough FEV1 and FEV1 2 hours post inhalation after 12 weeks of treatment. For both endpoints~     changes from baseline will be analysed. Three strata of patients will be included (severe~     COPD, i.e. <35% of predicted FEV1, moderate COPD, i.e. 35% - <50% of predicted FEV1, mild~     COPD, i.e. 50% - 70% of predicted FEV1, according to American Thoracic Society [ATS]~     criteria). The study is conducted in order to find out for which endpoint tiotropium is~     different from placebo in which stratum.~   "
250387|NCT00274794|"~     RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving colony-stimulating factors, such as G-CSF, monoclonal~     antibodies, such as rituximab, or chemotherapy, such as etoposide, helps stem cells move from~     the bone marrow to the blood so they can be collected and stored until transplant. Giving~     etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be~     an effective treatment for non-Hodgkin's lymphoma.~      PURPOSE: This randomized clinical trial is studying how well giving etoposide and G-CSF with~     or without rituximab works in treating patients who are undergoing an autologous peripheral~     stem cell transplant for B-cell non-Hodgkin's lymphoma.~   "
250388|NCT00274781|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and gemtuzumab ozogamicin,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more cancer cells.~      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with~     gemtuzumab ozogamicin works in treating patients with advanced myelodysplastic syndromes.~   "
250389|NCT00274768|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well capecitabine works in treating patients~     with metastatic breast cancer.~   "
250390|NCT00274755|"~     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and magnetic~     resonance spectroscopic imaging (MRSI), (done before, during, and after treatment) may help~     doctors predict a patient's response to treatment and help plan the best treatment.~      PURPOSE: This phase II trial is studying how well MRI and MRSI evaluate patients who are~     undergoing treatment for gliomas.~   "
250391|NCT00274742|"~     The purpose of this study is to determine whether a continuous infusion of Blinatumomab~     (MT103) is safe in the treatment of relapsed Non-Hodgkin's Lymphoma.~      Furthermore, the study is intended to provide pharmacokinetic and pharmacodynamic data of~     Blinatumomab as well as to get first indication of tumour activity.~   "
250392|NCT00274729|"~     The purpose of this study is to investigate the effect of three diets different in type and~     amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.~   "
250393|NCT00274716|"~     The objective of this study is to evaluate the safety and efficacy of two investigational~     drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with~     hypertension (high blood pressure).~      This is an early phase trial and some specific protocol information is proprietary and not~     publicly available at this time. (Full information is available to trial participants).~   "
250394|NCT00274703|"~     Eosinophils play a key role in the pathogenesis of eosinophilic oesophagitis. Therapies that~     suppress eosinophil recruitment and activation may give a benefit. Mepolizumab is a humanised~     monoclonal antibody against interleukin-5 (IL-5). This study will evaluate the ability of~     mepolizumab to decrease the recruitment and infiltration of eosinophils into the oesophagus,~     thereby reducing the inflammation and symptoms of EE (eosinophilic oesophagitis) in adult~     patients.~   "
250395|NCT00274690|"~     The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic~     medication to prevent nausea and vomiting in females after surgery.~   "
250396|NCT00274677|"~     This study is an 8-week evaluation of an investigational drug for treating depression in~     bipolar patients. Depressed patients will be given either an investigational drug or placebo~     and receive psychiatric assessments of their depression at weekly visits. Study drug and all~     study-related visits are provided at no cost to the patient. The patient agrees to meet with~     study research staff for roughly 11 clinic visits.~   "
250397|NCT00274664|"~     Amblyopia (‘lazy eye’) is the commonest visual disorder of childhood and is caused by an~     interruption to visual development. Occlusion of the better eye by patching is the mainstay~     of treatment, so forcing use, of the affected eye. We have little understanding of how much~     treatment is required for improvement, so occlusion may continue for many months. This is~     both demanding for the child and family as a whole. Treatment outcome is frequently~     unsatisfactory. Compliance is often poor, thus we do not know precisely how much treatment~     the child actually receives or how much is required.~      To overcome this, we have designed an instrument that permits us to measure occlusion: an~     occlusion dose monitor (ODM) which provides an objective record of how much occlusion a child~     actually receives. Recently we have observed that 75% of improvement induced by occlusion~     occurs in the first four weeks of treatment. In this study we explore the possibility that by~     intensive treatment the period of amblyopia therapy can be shortened – i.e. treatment will be~     more efficient, more effective, and more ‘family-friendly’. The study hypothesis is that 12~     hours/day of patching is more effective than 6 hours/day.~   "
250398|NCT00274651|"~     Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with~     recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101~     is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with~     belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.~   "
250399|NCT00274638|"~     To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior~     to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate~     hypertensives.~   "
250400|NCT00274625|"~     The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture~     closure alone in preventing an incisional hernia after open bariatric surgery.~   "
250401|NCT00274612|"~     The primary objective of this study is to demonstrate that telmisartan 80 mg (MICARDIS®) is~     at least as effective and possibly superior to ramipril 5mg and 10mg in lowering mean~     ambulatory diastolic blood pressure (DBP) and systolic blood pressure (SBP) during the last 6~     hours of the 24-hour dosing interval in mild-to-moderate hypertensive patients at the end of~     an 8 and 14-week treatment period, respectively.~   "
250402|NCT00274599|"~     Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril~     5mg & 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing~     interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.~   "
250405|NCT00274560|"~     The objective of the study was to evaluate the degree of improvement in lung function in~     patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium~     inhalation capsules compared to salmeterol inhalation aerosol .~   "
250406|NCT00274547|"~     The primary objective of this trial is to determine whether treatment with tiotropium (18~     mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD~     experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation~     during a six month observation period.~   "
250407|NCT00274534|"~     To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to~     Salmeterol MDI in patients with moderate to severe COPD.~   "
250408|NCT00274521|"~     The study was designed to determine whether tiotropium inhalation capsules, compared to~     placebo, enhances the improvement in exercise tolerance seen in patients with chronic~     obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. In~     addition, assessments of the effect of tiotropium on dyspnea and quality of life following~     pulmonary rehabilitation were taken.~   "
250409|NCT00274508|"~     To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD~   "
250410|NCT00274495|"~     To study the effectiveness and safety of adding Rosiglitazone, an insulin sensitizing agent~     to people with chronic hepatitis C infection genotype 1 with fatty liver disease, who are~     being treated with standard therapy. Standard therapy consists of weekly pegylated interferon~     injections and daily ribavirin pills, whose dosage is weight based. This regimen in genotype~     1 patients is effective in only 45% of patients at best. In addition, this therapy must be~     given for 48 weeks to be effective and has alot of side-effects. One risk factor for a poor~     response is fatty liver. Rosiglitazone has been shown to be effective in the treatment of~     patients with fatty liver alone. This study hopes to show that the addition of Rosiglitazone~     to the standard therapy in genotype 1 patients with fatty liver disease will increase~     effectiveness of the standard therapy of hepatitis C.~   "
250411|NCT00274469|"~     The purpose of this study is to compare the efficacy and tolerability of Faslodex~     (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor~     positive advanced breast cancer.~   "
250412|NCT00274456|"~     This was an open-label study conducted comparing the toxicity and antitumor activity of~     ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).~   "
250413|NCT00274443|"~     This is an open-label dose escalation trial using ABI-007 plus carboplatin.~   "
250414|NCT00274430|"~     A double-blind placebo controlled study~        -  To compare the effect of tadalafil and dexamethasone versus placebo on Ppa and pulmonary~          edema formation in subjects susceptible to HAPE.~        -  To investigate the effect of dexamethasone on alveolar fluid clearance, as assessed by~          measurement of the nasal potential difference, and prevention of HAPE.~        -  To investigate the effect of the tadalafil and dexamethasone versus placebo on the~          dynamic CBF autoregulation properties and on the development of AMS in HAPE susceptible~          subjects.~   "
250415|NCT00274417|"~     This study is for individuals electing to have GreenLight Photoselective Vaporization of the~     Prostate (PVP) to treat symptoms from an enlarged prostate gland. The purpose of this~     research study is to evaluate the safety and effectiveness of the medication dutasteride as~     compared to placebo (an inactive substance) for improving surgical and long-term outcomes of~     PVP. Dutasteride is approved by the United States Food and Drug Administration (FDA) for the~     treatment of symptoms from an enlarged prostate gland. The use of dutasteride to improve the~     outcomes of PVP is investigational. The study will last for approximately 15 months and will~     involve 6 visits.~   "
250416|NCT00274404|"~     The hypothesis is that an antiviral drug (valacyclovir) will reduce the amount of~     Epstein-Barr virus (EBV) in the mouths of university students with infectious mononucleosis~     (mono) while being a safe drug. Because EBV is the cause of mono, it is expected that~     reduction of the amount of virus could result in faster recovery from the disease.~   "
250417|NCT00274391|"~     The purpose of this research study is to determine whether the combination of inhaled~     amiloride and a concentrated salt solution is better than the salt solution itself for cystic~     fibrosis (CF) patients. In CF, airway secretions are thick and dehydrated. Many patients use~     inhaled salt solutions to help draw water into their secretions so that they are easier to~     get rid of with chest physiotherapy (“chest PT”) and cough. Unfortunately, these salt~     solutions are reabsorbed very quickly by the airways, so the beneficial effects may not last~     very long. In the hopes of prolonging their effects, the drug amiloride could be used in~     combination to slow salt and water reabsorption from airways. Amiloride is a medication that~     has been given by mouth for high blood pressure for many years. It is possible that the~     combination of salt solutions and inhaled amiloride may significantly improve the clearance~     of secretions in CF, which would be expected to improve lung function in CF.~   "
250418|NCT00274378|"~     Allomatrix is a combination of Demineralized Bone Matrix with a binding medium of calcium~     sulfate hemihydrate and carboxymethylcellulose. Allomatrix combines the osteoinductive~     capacity of DBM with the osteoconduction and controlled resorption of surgical grade calcium~     sulfate.~      Unstable fractures of the distal radius do not resist displacement once it has been~     manipulated into an anatomical position.~      There is a parallel between the quality of the anatomic result and the residual capacity of~     the wrist, except in older, low demanding patients.~      Injectable osteoconductive cements have been introduced to fill voids in metaphyseal bone and~     may provide a better stability around hardware in osteoporotic bone and help maintain~     reduction of fracture fragments.Moreover, a product like ALLOMATRIX could accelerate and~     improve bone healing and fracture stability by its osteoinductive properties. However, the~     clinical significance of these new bone graft materials still have to be proven in a~     randomised controlled study set-up.~   "
250419|NCT00274365|"~     Online consulatations through videoconference in the field of psychiatry given to general~     practitioners will reduce costs of medical treatment and improve service.~   "
250420|NCT00274352|"~     The purpose of this study is to determine if adalimumab is an effective for the skin~     manifestations of sarcoidosis.~   "
250436|NCT00274144|"~     Effects of AT1 receptor antagonist telmisartan on the primary endpoint inflammatory~     parameters in patients with coronary artery disease (CAD). Secondary endpoints are~     alterations in clinical course and blood pressure~   "
250421|NCT00274339|"~     The purpose of this study is to evaluate changes in scores on the Reflux Finding Score and~     Reflux Symptom Index over a 24 week period. To enroll subjects must score at least a 13 on~     the Reflux Symptom Index and at least a 5 on the Reflux Finding Score. All subjects will~     receive education on lifestyle modifications with a nutritionist and exercise trainer. All~     subjects will be expected to comply with lifestyle modifications for the entire study period~     of 24 weeks. Half of all subjects will receive Prevacid 30mg BID and half will receive~     placebo BID for 24 weeks. Subjects will have 4 office visits over 24 weeks and weekly~     contacts with the study staff to assess Reflux Symptom Index and any health or medication~     changes.~   "
250422|NCT00274326|"~     Primary:~        -  To assess the efficacy of SR121463B in correcting hyponatremia in patients with~          dilutional hyponatremia other than SIADH or cirrhosis~      Secondary:~        -  To assess the long-term efficacy of SR121463B in maintaining normonatremia in these~          patients~        -  To assess the safety and tolerability of SR121463B~   "
250423|NCT00274313|"~     The purpose of this study is to evaluate the safety and tolerability of a new inhaled~     sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be~     inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate~     blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and~     eliminated after 14 days of treatment.~   "
250424|NCT00274300|"~     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where~     administrations are given and any effects it may have on subjects' wellbeing. The study will~     also test the ability of vaccine to cause particular immune responses in the body and~     evaluate the effect it has on herpes outbreaks~   "
250425|NCT00274287|"~     This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance~     program in patients with androgen-independent prostate cancer (AIPC) who have achieved a~     maximal response on a taxotere or other chemotherapy schedule.~   "
250426|NCT00274274|"~     This trial is conducted in Europe. This trial aims for a comparison of the efficacy and~     safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy,~     with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.~   "
250427|NCT00274261|"~     This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use~     of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of~     contraception over six months (183 days) and at least six cycles of use. In addition, there~     is an opportunity for subjects to continue with study treatment for up to twelve months (365~     days) and twelve cycles of treatment upon completion of the first six months of treatment.~   "
250428|NCT00274248|"~     This is a phase 1, open-label, multicenter study investigating the use of MLN518 in~     combination with standard chemotherapy to patients with newly diagnosed AML. Two dose levels~     of MLN518—200 mg and 400 mg given orally twice a day are planned for sequential evaluation in~     separate groups of patients. Patients assigned to the 400 mg dose level given orally twice a~     day of MLN518, will potentially have their dose of MLN518 adjusted on the basis of MLN518~     plasma concentrations measured during the first 3 days of induction therapy. All patients~     will receive initial induction chemotherapy with cytarabine, 200 mg/m2/day by CIVI on Days 1~     through 7, and with daunorubicin, 60 mg/m2/day by intravenous (IV) push (IV infusion if~     borderline cardiac function is detected) on Days 1 through 3 (7+3). An abbreviated~     cytarabine and daunorubicin regimen (5+2) will also be used when the initial remission~     induction therapy fails to clear the bone marrow of blast cells (as typically detected on the~     Day 15 bone marrow) and a second attempt at remission induction is indicated. Patients who~     achieve a complete remission (CR) will receive consolidation therapy with HiDAC (standard or~     modified) in combination with continued MLN518 treatment. Patients remaining in continuous CR~     after completion of their last cycle of consolidation therapy will be permitted to continue~     treatment with single-agent MLN518 for 6 months thereafter.~   "
250429|NCT00274235|"~     Malaria in pregnancy is one of the most important preventable causes of low birthweight~     worlwide and a major cause of severe maternal anaemia contributing to maternal mortality.~     Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently~     adopted government recommendation for malaria control during pregnancy in Benin, but the~     emergence and the spread of resistance to SP justifies the evaluation of alternative~     anti-malarial drugs. Mefloquine (MQ), which has been proven effective and reasonably safe in~     this indication, may be an interesting alternative to SP. The aim of this trial is to compare~     the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for IPT. It is an~     equivalent study designed to test the hypothesis that MQ is as efficacious as SP to prevent~     malaria in pregnancy, and that it could replace SP when resistance of Plasmodium falciparum~     becomes too elevated. Primary endpoint will be the proportion of infants with low~     birthweight. Secondary endpoints will be the proportion of mothers with placental plasmodial~     infection, and the proportion of mothers with anaemia at delivery.~   "
250430|NCT00274222|"~     This study was designed to evaluate the hypothesis that nebulized budesonide) might be an~     alternative to systemic corticosteroids (SC) in the treatment of patients with acute~     exacerbations of COPD (AECOPD).~   "
250431|NCT00274209|"~     Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy~     with dye spraying can detect subtle abnormalities that are not visible with standard~     endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer targeted~     biopsies can replace standard colonoscopy with multiple random biopsies.~   "
250432|NCT00274196|"~     The purpose of this study is to measure the sensitivity and specificity of ultrasound exam of~     the hip in diagnosing occult hip fractures.~   "
250433|NCT00274183|"~     Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan.~     However, the prevalence and clinical characteristics have not been studied well. The purpose~     of this study is to resolve the aforementioned problem.~   "
250434|NCT00274170|"~     : Headaches are a common complaint presenting to the emergency department (ED), accounting~     for 1-2% of all ED visits, with migraines as the second most common primary headache~     syndrome. Patients that ultimately present to the ED have failed outpatient therapy and~     exhibit severe and persistent symptoms. Treatment options have been traditionally with a~     parenteral opiod, generally Demerol. Unfortunately, patients with chronic painful conditions~     like migraines have been prone to dependency. In 1986, a nonopioid, compazine was noted~     serendipitously to relieve migraine headache pain. 1 Nonopioid regimens have evolved as~     standard therapy in the treatment of migrainne headache in the ED. Today, there are a number~     of nonopioid treatment options, but not without their own individual concerns. Ergotamine and~     dihydroergotamine are effective, but commonly cause nausea and vomiting. Sumatriptan is~     expensive has recurrence rate, is ineffective in about 20-30%, and is contra-indicated in~     patients with cardiac disease. Metoclopramide, a dopamine receptor antagonist, commonly used~     as an anti-emetic agent, has been widely studied for use with acute migraines. Its side~     effects include drowsiness and dystonic reactions. Compazine has been successfully used to~     treat migraine headaches for the past several decades, and has been accepted as standard~     treatment of headaches in the ED. 2 Its side effect profile includes extrapyramidal effects,~     dysphoria, drowsiness and akathisias. The ideal medication for treating headaches would have~     no addictive properties, few side effects, quick onset, be highly effective and have a low~     rate of recurrence. Somatostatin is known to have an inhibitory effect on a number of~     neuropetides, which have been implicated in migraine. Native somatostatin is an unstable~     compound and is broken down in minutes, but octreotide, a somatostatin analogue has a longer~     half life. Intravenous somatostatin has been shown to be as effective as ergotamine in the~     acute treatment of cluster headache. 3 The analgesic effect of octreotide with headaches~     associated with growth hormone secreting tumor has been established. 4 Five somatostatin~     receptors have been cloned with octreotide acting predominantely on sst2 and sst5. The~     distribution of sst2 within the central nervous system strongly suggests that this particular~     somatostatin receptor has a role in cranial nociception, being highly expressed in the~     trigeminal nucleus caudalis and periaqueductal grey. Kapicioglu et.al performed a double~     blind study comparing octreotide to placebo in treating migraine. They found there to be a~     significantly greater relief of pain with octreotide at 2 and 6 hours compared to placebo~     (76% vs 25%, p<0.02). They noted that 47% of those in the octreotide group had complete~     relief compared to no patients in the placebo group. They went on to note that those patients~     in the octreotide group had earlier relief of symptoms and no side effects. The only minor~     adverse event related to the administration of octreotide was a local reaction in 3 patients~     (18%). In a study performed recently in Netherlands, no clinically relevant changes in vital~     signs, routine chemistry, and urinalysis were observed with octreotide use. Electrocardiogram~     analyses showed no newly occurring or worsening of known cardiac abnormalities 2 and 24 h~     after injection with octreotide. 5 Levy et. al also compared octreotide to placebo in a~     double blinded study but found no difference. This was a poorly designed study, in that the~     patients treated themselves at home with an injection of either placebo or octreotide for 2~     episodes of headache and recorded their level of pain relief at 2 hours. Matharu et. al also~     performed a double blind study comparing octreotide to placebo, but looking at cluster~     headaches rather than migraines. They found there to be a significant improvement with the~     use of octreotide over placebo (52% vs 36%). At Darnall Army Community Hospital the cost of~     100 mcg Octreotide and10 mg Compazine, is $10.46, $2.02-8.00, respectively.~   "
250435|NCT00274157|"~     The specific aims of the project are as follows:~      To determine whether catheter-based revascularization procedures improve functional capacity~     and quality of life among patients with intermittent claudication.~      To investigate whether improvements in walking ability result in a less sedentary lifestyle~     and improvement of the cardiovascular risk profile.~   "
250438|NCT00274118|"~     To compare the renal consequences of two different approaches to blocking the renin~     angiotensin system in subjects with hypertension and concurrent Type II diabetes mellitus and~     diabetic nephropathy.~   "
250439|NCT00274105|"~     The aim of this trial is to evaluate the efficacy and safety of telmisartan 80 mg~     administered once daily in patients with documented coronary artery disease (CAD) and a~     probably cardiovascular risk profile concerning the amelioration of structural alterations~     and endothelial function.~      The primary objective of this trial is to evaluate the efficacy in particular with regard to~     the percentage change of atheroma volume in the femoral artery.The secondary objective is to~     evaluate the change in the plaque size- assessed by intravascular ultrasound, the increase in~     Flow Dependent Dilation provoked by intraarterial infusion of three increasing concentrations~     of Acetylcholine, and the change in seated systolic blood pressure.~      Endothelial dysfunction is a primary event in atherogenesis and all known cardiovascular risk~     factors have been associated with endothelial dysfunction before atherosclerotic vascular~     disease manifests itself clinically. Pivotal to endothelial dysfunction is a disturbance in~     the function of endothelium-derived nitric oxide (NO). Recently, it could be shown that acute~     and chronic angiotensin-1 receptor antagonism reversed endothelial dysfunction in~     atherosclerosis. In experimental atherosclerosis, AT1 receptor blockade appears to have~     protective effects. Respective potential mechanisms include the prevention of endothelial~     injury, the augmentation of NO activity, the inhibition of lipid peroxidation and an~     antiproliferative effect. These findings together with the most recent data that losartan~     improves endothelial function and NO activity suggest that AT1 receptor antagonism may also~     be antiatherogenic in patients with atherosclerosis. Angiotensin II influences smooth muscle~     cell migration, hyperplasia, and hypertrophy. Angiotensin II also enhances production of~     local superoxide anion, which will inactivate nitric oxide. Inhibition of these reactions by~     the AT1-Blocker telmisartan may therefore interfere with atherosclerotic plaque formation.~   "
250440|NCT00274092|"~     The objective of this study is to compare the bronchodilator efficacy and safety of~     tiotropium inhalation capsules (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg~     q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)~   "
250441|NCT00274079|"~     The objective of the study is to determine the effect on lung function when either SPIRIVA~     once daily or placebo once daily is added to the usual therapy (care) of COPD patients naïve~     to anticholinergic agents managed in primary care. Previous studies have been in both~     hospital in and outpatients, with washout of some respiratory medications, this is the first~     study to be conducted in General Practice, the drug's anticipated environment.~      Data from this study, including the adverse event monitoring, and post study findings on~     physical examination, will be used to extend the safety database. Health Resource Utilisation~     (HRU) data will be recorded to be use with data from other sources for economic analysis of~     COPD treatment.~   "
250442|NCT00274066|"~     To evaluate acute effect of single dose of ipratropium (Atrovent) or fenoterol (Berotec) in~     comparison to placebo when given to COPD patients on pharmacodynamic steady state of~     tiotropium (Spiriva)~   "
250443|NCT00274053|"~     The purpose of this study is to investigate the effect of a 9-month treatment of tiotropium~     (SPIRIVA®) 18 mcg once daily on Health Related Quality of Life and lung function in patients~     with a Chronic Obstructive Pulmonary Disease.~   "
250444|NCT00274040|"~     Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2~     puffs of 20 mcg, four times daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study~     in Adults with Chronic Obstructive Pulmonary Disease (COPD).~      The objective of this study is to compare the bronchodilator efficacy and safety of~     tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg~     q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).~   "
250445|NCT00274027|"~     To explore the mechanisms of dyspnea relief during exercise in patients with COPD following~     treatment with tiotropium bromide (Spiriva)~   "
250446|NCT00274014|"~     The objectives of this study were to evaluate the effect of a one-year treatment with inhaled~     tiotropium bromide 18 mcg once daily on lung function, incidence and severity of~     exacerbations in patients with chronic obstructive pulmonary disease (COPD).~      The secondary purpose was to explore possible relationships between lung function changes and~     occurrence of COPD exacerbations and to try to characterize these exacerbations.~   "
250447|NCT00274001|"~     The purpose of this trial is to compare the effect of switching to nevirapine~     (Viramune®)-containing regimen on quality of life of patients with fat abnormalities and~     virological control whilst receiving a PI-based regimen.~   "
250448|NCT00273988|"~     The purpose of this study was to determine the effects of nevirapine treatment on the~     pharmacokinetics of methadone in HIV-1 infected, opioid-dependent adults who had been on a~     stable methadone maintenance therapy for at least five days prior to study entry.~   "
250449|NCT00273975|"~     Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and~     nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when~     administered for 48 weeks in antiretroviral drug naïve paediatric patients.~   "
250450|NCT00273962|"~     To compare the bronchodilator efficacy of ipratropium plus salbutamol (Combivent) with~     salbutamol alone given every 20 minutes for three doses in asthmatic children with severe~     acute exacerbation~   "
250451|NCT00273949|"~     The purpose of this study is to assess the ability of lactulose, a prebiotic agent, to~     prevent hospital acquired infection in children~   "
250452|NCT00273936|"~     The purpose of this study is to determine the safety and maximum tolerated dose,~     pharmacokinetics, and anti-neoplastic response of AVN-944 in patients with advanced~     hematologic malignancies.~   "
250453|NCT00273910|"~     This study will evaluate the immunization effects of a vaccine for patients who are at risk~     for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has~     invaded deep into the skin or lymph nodes. Currently, the only therapy that the U.S. Food and~     Drug Administration (FDA) has approved for preventing recurrence of melanoma is~     alpha-interferon. But the research data are controversial. In this study, the vaccine to be~     used, called gp100, contains a piece of a protein called a peptide, which melanoma cancer~     cells produce.~      Patients 16 and older who have had confirmed melanoma surgically removed and whose tissue~     type is tested as being human leukocyte antigen serotype within HLA-A serotype group~     (HLA-A2), through a specific blood test, may be eligible for this study.~      Up to 132 participants will be enrolled. There will be a physical examination and collection~     of blood samples for tests, and making sure that x-rays and scans are current. Patients will~     be randomly assigned to four groups. Group 1 will receive the peptide with an adjuvant~     (assistant) oil-based liquid called Montanide ISA-51, as an injection in the thigh. Group 2~     will receive gp100, Montanide, and a cream called imiquimod, which the FDA has approved for~     treating genital warts and herpes but that may help immune cells in the skin to recognize the~     vaccine. Imiquimod will be applied to the skin for 5 days. Group 3 will receive gp100 mixed~     in salt water given as several mini-doses under the skin of the thigh. Group 4 will also~     receive several mini-doses of gp100 mixed in saline, as well as imiquimod cream applied to~     the skin for 5 days. All patients will receive the gp100 every 3 weeks for 12 weeks. Every~     dose is a cycle, with four cycles considered a course of therapy. If the melanoma does not~     return or patients do not experience side effects from this therapy, then the courses of~     vaccine will repeated for up to 12 cycles of therapy (3 courses over 33 weeks). Side effects~     of the peptide vaccination include local swelling, swelling of local lymph nodes, bruising,~     and pain and redness at the injection sites. There may be chills or fever. Patients will be~     watched closely for such side effects.~      To study how the vaccine changes the action of cells in the immune system, patients' white~     blood cells (lymphocytes) will be obtained, involving a separate informed consent. The~     procedure, called leukaphersis, requires inserting a needle into the arm, to obtain blood~     going into a machine, which divides the blood into red cells, plasma (or the serum part), and~     lymphocytes. The lymphocytes are removed, and the plasma and red cells returned to the~     patient through a second needle in the other arm. Risks associated with the procedure include~     fainting, which can be prevented by patients' eating before coming to the lab, and bleeding~     and infection at the needle site. Patients will undergo leukapheresis will be done about four~     times: before receiving the vaccine, 3 weeks after the first four doses, and then after 8~     cycles and 12 cycles. Patients assigned to the groups receiving imiquimod will be asked to~     record every time they apply that cream and describe any symptoms developed during the study.~     All patients will be watched closely for any sign that their melanoma has returned. Before~     and throughout the study, multiple blood tests will be conducted.~      The vaccine, Montanide, and imiquimod may increase patients' immune system in fighting off~     new tumors, but that is not known now. However, the study may provide information that will~     be useful in treating melanoma patients in the future.~   "
250467|NCT00273728|"~     Background: In patients with severe sepsis and septic shock early aggressive volume~     replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions.~     The role of modern, low molecular weight, starch preparations and their influence on the~     course of disease is not determined yet.~      Hypothesis: The purpose of this study is to determine wether initial infusion therapy with~     Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care~     Unit and hospital length of stay without impairment of renal function~      Design: Double-blind, randomized, controlled monocentric study~      Setting: Intensive Care Units of a University Hospital~      Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock~      Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW~     130, substitution 0.4) in the first five days of intensive care treatment.~      Parameter:~        -  Intensive Care length of stay~        -  Hospital length of stay~        -  Mortality~        -  Kidney function~      Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay.~     Unpaired t-Test for kidney function parameters.~      Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl~     starch group~   "
250454|NCT00273897|"~     This study will test whether DC electrical polarization of the brain can temporarily improve~     hand function in patients with corticobasal syndrome (CBS). In this degenerative disorder of~     the brain, nerve cells die over time, causing a progressive decline in the patient's ability~     to use their hands. This is always worse on one side. Other symptoms include arm or leg~     stiffness, tremor, gait unsteadiness, and speech difficulty. Some patients also have some~     decline in thinking ability, such as loss of skilled activities, poor problem solving~     abilities poor concentration, problems with language, and forgetfulness,. DC electrical~     polarization of the brain involves placing sponge electrodes on the head and passing a very~     weak current between them. DC polarization can temporarily improve the ability of healthy~     people to make word lists and may improve symptoms in some brain diseases.~      Patients 40 and older with CBS who have participated in NINDS protocol 02-N-0001 (Testing a~     Model of the Representational Knowledge Stored in the Human Prefrontal Cortex) may be~     eligible for this study. In protocol 02-N-0001, participants provide a medical history,~     undergo a neurological examination, PET scanning and MRI, and complete tests, such as sitting~     in front of a computer monitor and press a key to indicate a decision about what appears on~     the screen (for example, whether a statement is accurate) and answering questions from a test~     examiner.~      For the current protocol, participants have three 2-hour testing sessions at the NIH Clinical~     Center, scheduled at least one day apart. In each session, sponge electrodes are placed on~     the head so that they affect different areas of the brain. Two areas are involved with hand~     movement; the third does not. The electrodes are dampened with water and attached to the~     sides of the patient's head. When the current is turned on, the patient may feel some~     tingling. The current is on for 40 minutes, but can be reduced or stopped early if the~     tingling becomes uncomfortable.~      Before and during each session, the patients' hand function is tested by having them perform~     and imitate some actions, insert pegs into holes on a board, and tap their index finger as~     fast as they can. Part or all of the sessions are videotaped for use in evaluating the~     effects of DC polarization.~   "
250455|NCT00273884|"~     This protocol is designed to assess the safety and efficacy of amonafide in combination with~     cytarabine in subjects with previously untreated secondary AML.~   "
250456|NCT00273871|"~     The purpose of the study is to determine the effect of conversion from calcineurin inhibitor~     based therapy to Rapamune based therapy in patients with mild to moderate renal~     insufficiency.~   "
250457|NCT00273858|"~     This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety~     of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or~     50mg of etanercept once weekly. The improvement of health-related quality of life will also~     be evaluated.~   "
250458|NCT00273845|"~     The broad goal of this study is to assess the effectiveness of two interventions to~     facilitate treatment linkage and treatment engagement. Treatment linkage is operationally~     defined as completion of agency intake procedures and attendance at the first clinical or~     therapy session. Treatment engagement represents a more comprehensive conceptualization of~     treatment retention and includes measures of the clinical and ancillary services actually~     received by the client over time; as such, client engagement focuses on the intensity and~     duration of treatment participation. This study will enhance the CIU concept by conducting a~     controlled trial, using a three-armed research design, of interventions designed to enhance~     treatment linkage and treatment engagement. These interventions - a Motivational Intervention~     and Strengths-Based Case Management - are science-based and have demonstrated efficacy in~     moving drug abusers towards treatment and supporting treatment engagement.~   "
250459|NCT00273832|"~     The purpose of this study is to determine whether coronary artery computed tomography~     scanning is a more rapid, less expensive and safe alternative to standard diagnostic~     evaluation of patients with acute chest pain in the emergency room.~   "
250460|NCT00273819|"~     The purpose of this study is to test the ability of a new X-ray technique called CT~     angiography to identify significant narrowing of the coronary arteries compared to~     traditional coronary angiogram.~   "
250461|NCT00273806|"~     The purpose of the study is to determine whether a program of screening and intervention for~     four health risk behaviors (smoking, problem drinking, sedentary lifestyle, unhealthy diet)~     carried out by medical assistants in primary care practices can help patients improve their~     behaviors. The hypothesis is that patients who receive the intervention will demonstrate~     higher rates of health behavior change than patients who receive usual care.~   "
250462|NCT00273793|"~     Incentives can be used to facilitate the acquisition of many healthy behaviors, such as~     smoking cessation. However, there is much room for improvement in the use of incentives. This~     study investigates how two aspects of providing incentives influence the effectiveness of~     using incentives to promote smoking cessation. One aspect is the criterion for providing~     incentives, e.g., whether to require smoking cessation before providing an incentive or to~     provide incentives following smoking reductions. The other aspect being investigated is~     whether it is best to use a fixed incentive amount or an amount that increases with continued~     cessation success.~   "
250463|NCT00273780|"~     This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to~     determine the effect of cognitive and behavioral interventions on HAART adherence.~   "
250464|NCT00273767|"~     The main objective is to observe the effects of erythropoietin administration on different~     blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.~   "
250465|NCT00273754|"~     This is a research study using caffeine in children who have an obstructive sleep apnea~     (OSA). OSA means children who stop breathing during their sleep due to obstruction in their~     airway. The purpose of this study is to determine whether caffeine when given in the vein,~     will wake children up faster and decrease post-anesthesia airway obstruction, as well as the~     safety and if the drug agrees with the child compared to a placebo (an inactive or dummy~     agent).~   "
250466|NCT00273741|"~     The aim/objective of this study is to evaluate the antiasthenic effect of methylphenidate~     with a visual analogical scale (VAS) after 7 days of treatment, in cancer patients, in~     palliative care, i.e. with a progressive or terminal disease.~   "
250468|NCT00273715|"~     Skin closure either by sutures or staples is required after any surgical procedure of the~     hip.~      The purpose of this study is to compare the amount of drainage between patients who have had~     either staples or sutures placed for skin closure.~   "
250497|NCT00273338|"~     The primary objective of this study is:~        -  To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on~          survival in metastatic androgen-independent prostate cancer~      The secondary objectives of this study are:~        -  To determine the effect of the ASCENT regimen on the rate of thromboembolic events~          (blood clots)~        -  To determine the effect of the ASCENT regimen on prevention of skeletal-related events~          (fractures)~        -  A Separate sub-study will be conducted at selected study sites in North America to~          determine the population PK of DN-101.~   "
250469|NCT00273702|"~     After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine~     600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day~     at visit 6 unless clinical improvement has been attained at a lower dose (clinical~     improvement will be assessed by the investigator with respect to gambling thoughts, urges and~     behavior). If it is clinically necessary to modify this schedule (e.g., because of side~     effects or an adequate response to a lower dose), the dose will be raised more slowly or the~     target dose will not be reached.~      Subjects will start no other psychotropic medications during the study but may continue on~     previously prescribed psychotropic medications if on a stable dose for 3 months prior to~     study entry. Psychotherapy of any form (including cognitive-behavioral therapy) will not be~     initiated during the study but subjects may continue with current psychotherapy if they have~     been undergoing therapy for at least three months prior to study entry.~      Subjects will be evaluated with the PG-YBOCS, G-SAS, CGI, HAM-D, HAM-A and the Sheehan~     Disability Inventory at screening and at each visit for the remainder of the study.~     Medication side effects will be evaluated at each study visit. A tablet count will be kept~     for each dose of medication taken.~   "
250470|NCT00273689|"~     The purpose of the study is to test how well 2 different medications stop asthma symptoms~     caused by exercising. The two medications that will be tested are pretreatment with~     albuterol and montelukast (Singulair®). Although both medications are used for treating~     asthma, we don't know which medicine is better at stopping asthma symptoms caused by~     exercising.~   "
250471|NCT00273676|"~     Patients with severe community-acquired pneumonia are included Half of the patients are~     treated with a 3 day course of intravenous antibiotics, followed, when clinical stable, by a~     course of oral antibiotics. Efficacy of this treatment is compared to a standard course of 7~     days of intravenous antibiotics, which treatment is assigned to the other half of patients.~     Outcomes measured are clinical cure and costs.~   "
250472|NCT00273663|"~     Direct stimulation of the cerebral cortex induces an increase in cerebral blood flow.~     Although this information is known, it has never been documented during Transcranial Cerebral~     Electrical Stimulation (TCES), which is a non invasive technique. It is used to modulate the~     opiate endogenous system, mainly in opioid users but no cerebral blood flow mapping of the~     anatomic regions involved in this modulation of the opiate system under electrical~     stimulation has been performed in functional Computerized Tomography.~   "
250473|NCT00273650|"~     We will be testing a specific dietary supplement, methylcobalamin (vitamin B12). Follow-up~     assessments with our clinical team will take place over the 12-week study period so that we~     can record any changes in development. The main goal of this study is to determine if~     subcutaneous injections of vitamin B12 given every three days can positively affect behavior~     and development in children with autism.~      Hypothesis: Methylcobalamin injections will improve measures of executive function, speech,~     and socialization in children with autism, and will be associated with metabolic improvement.~   "
250474|NCT00273637|"~     The goal of this study is to better characterize peripartum cardiomyoapthy or~     pregnancy-related cardiomyopathy by enrolling as many PPCM survivors as possible using both~     direct and web-based methods of recritment. Patients will anser a questionnaire regarding the~     onset, progression, treatment and follow-up of their diagnosis as well as the psychosocial~     aspects of PPCM.~   "
250475|NCT00273624|"~     60 patients with major depression will be treated with 10 mg Olanzapine or Placebo for 2~     weeks. In case of response (reduction of depressive symptoms)the study will be continued for~     further 60 days.~   "
250476|NCT00273611|"~     Vitamin D is important to maintain good health. Although it is found in foods and vitamins,~     many people still have low vitamin D levels. One purpose of this study is to describe vitamin~     D levels from patients at the University of Colorado Seniors Clinic. Another goal of the~     study is to find out if education by a pharmacist can increase vitamin D levels in patients~     who have low vitamin D levels.~   "
250477|NCT00273598|"~     Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of~     life, functional outcome, cosmetic result, and the correction of spinal deformity of two~     instrumentation systems for the treatment of adolescent idiopathic scoliosis.~   "
250478|NCT00273585|"~     The purpose of this study is to determine whether a newly developed educational software~     program is effective in increasing patients' confidence in their ability to undergo colon~     cancer screening. If the software is effective in this regard, the study will also determine~     if increased confidence to undergo screening leads to more people being screened and to~     people feeling as though their decision about screening was informed.~   "
250479|NCT00273572|"~     The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to~     increase leisure-time physical activity and reduce body weight will improve the parameters of~     the metabolic syndrome and quality of life among obese, non-diabetic Arab women~   "
250480|NCT00273559|"~     The purpose of this study is to compare the risks and benefits of steroid elimination versus~     steroid therapy in renal transplant patients particularly looking at the effects on bone~     mass, lipids, hypertension, and new onset diabetes.~   "
250481|NCT00273546|"~     -  1.To compare overall survival after treatment with the test tri-therapy (TPF: docetaxel~          plus cisplatin and 5FU) or the control treatment (PF: cisplatin plus 5-FU) followed by~          chemoradiotherapy in patients with locally advanced SCCHN.~        -  2.The main secondary endpoint is progression free survival (PFS). The other secondary~          endpoints are to evaluate and compare improvement of local symptoms; time-to-treatment~          failure; quality of life; clinical complete response rate (CR and CR/PR); toxicity and~          to evaluate the relationship of tumor markers and response to therapy.~   "
250482|NCT00273533|"~     The present study is designed to evaluate the hypothesis that the Angiotensin‐Converting~     Enzyme (ACE) inhibitor Ramipril improves vascular function and reduces markers of low-grade~     chronic inflammation and oxidative stress in patients with Rheumatoid Arthritis.~   "
250498|NCT00273325|"~     Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents~     the invasive disease from Streptococcus pneumoniae in full-term infants, but was not~     thoroughly studied in premature infants. This study evaluated the effectiveness and safety of~     the vaccine given in routine practice to very low birth weight infants, looking at blood~     antibody levels 4-6 weeks after the final vaccine dose, and adverse events, survival,~     infections, and neurodevelopmental outcomes at 18-22 months corrected age.~   "
250483|NCT00273520|"~     Primary Objective:~        -  The primary objective is to evaluate the clinical efficacy of telithromycin versus~          placebo as a supplement to the usual standard of care during an acute exacerbation of~          asthma. Efficacy will be assessed by:~             -  Changes in the diary card summary symptom score assessed daily for 6 weeks, and~             -  Changes in the domiciliary morning Peak Expiratory Flow Rate (PEFR) following oral~               telithromycin treatment~      Secondary Objectives:~      The secondary objectives of the study are:~        -  To evaluate the microbial activity of telithromycin during an exacerbation of asthma by:~             -  Assessment of the patient's clinical improvement relative to initial C. pneumoniae~               or M. pneumoniae status, and~             -  Analysis of the quantitative changes from baseline in C. pneumonia or M. pneumoniae~               by culture and quantitative Polymerase Chain Reaction (PCR).~        -  To evaluate the safety of 10 days of oral telithromycin as a supplement to the standard~          of care for patients with acute exacerbations of asthma~        -  To assess additional efficacy endpoints and health outcome evaluations following 10 days~          of treatment with either oral telithromycin or placebo, with either treatment used as a~          supplement to the standard of care for patients with acute exacerbations of asthma:~             -  Changes and daily variability in the PEFR during the 6 weeks of study treatment,~             -  Health status at follow-up (6 weeks)~             -  Pulmonary function tests:~                  -  Forced Expiratory Volume in 1 second (FEV1)~                  -  Forced Vital Capacity (FVC)~                  -  Forced Expiratory Flow Rate (FEF25-75%)~             -  Need for additional medications (e.g., inhaled corticosteroids, oral~               corticosteroids, bronchodilator use),~             -  Time to next acute exacerbation of asthma.~   "
250484|NCT00273507|"~     Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC~     (IB, IIA, IIB, and IIIA/N2).~   "
250485|NCT00273494|"~     Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease.~      Patients are randomised to surgery or not.~   "
250486|NCT00273481|"~     To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus~     the LTFC given once every morning following a run-in period with timolol maleate given twice~     daily.~   "
250487|NCT00273468|"~     To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced~     Nausea and Vomiting (CINV)~   "
250488|NCT00273455|"~     To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed~     combination given twice daily versus bimatoprost given once every evening in patients with~     open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy~   "
250489|NCT00273442|"~     To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol~     maleate fixed combination because they are insufficiently controlled on latanoprost~     monotherapy.~   "
250490|NCT00273429|"~     To compare the 24-hour efficacy and safety, measured every three hours, of the~     dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each~     given once daily.~   "
250491|NCT00273416|"~     The primary aim of this study is to assess how effective PF-00592379 is in restoring penile~     erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits~     where they will receive the following in random order; 2 separate doses of PF-00592379,~     sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on~     penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM~     technique).~   "
250492|NCT00273403|"~     This outcome evaluation effort provides the opportunity to learn what programmatic approaches~     effectively address two of the most difficult hurdles in HIV health services delivery: (1)~     getting people who would benefit from health care to use it and (2) getting people who do use~     health care to do so more consistently and effectively. The New York HIV Planning Council~     (through MHRA) has funded 23 agencies to achieve these objectives for people of color with~     HIV disease.~   "
250493|NCT00273390|"~     This project is designed to test the hypothesis that inhibition of binding between tumor~     necrosis factor alpha (TNF-alpha) and its receptors using Remicade (infliximab, chimeric~     mouse/human IgG1K monoclonal antibody directed against human TNF-alpha, Centocor, Malvern,PA)~     is clinically useful for patients with uveitis that is refractory to other forms of systemic~     immunosuppressive therapy.~   "
250494|NCT00273377|"~     The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen~     reduce wound infection risk in patients undergoing colon resection. The investigators will~     simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for~     postoperative nausea and vomiting) does not increase infection risk.~   "
250495|NCT00273364|"~     Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases,~     it starts as a relapsing-remitting disease with distinct attacks and no symptoms between~     flares. Over years or decades, virtually all cases transition into a progressive disease in~     which insidious and slow neurologic deterioration occurs with or without acute flares.~     Relapsing-remitting disease is often responsive to immune suppressive or modulating~     therapies, while immune based therapies are generally ineffective in patients with a~     progressive clinical course. This clinical course and response to immune suppression, as well~     as neuropathology and neuroimaging studies, suggest that disease progression is associated~     with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune~     mediated demyelination. Therefore, immune based therapies, in order to be effective, need to~     be started early in the disease course while MS is predominately an immune-mediated and~     inflammatory disease. While current immune based therapies delay disability, no intervention~     has been proven to prevent progressive disability. We propose, as a randomized study,~     autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG~     versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone,~     natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite~     treatment with alternate approved therapy.~   "
250496|NCT00273351|"~     Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by~     rigidity, bradykinesia, postural instability, and tremor. Clinical decline reflects ongoing~     degeneration of dopamine-containing neurons. A critical unmet need for clinical research is~     to improve early detection of these diseases by developing tools to assist with earlier~     diagnosis. Biomarkers are broadly defined as characteristics that are objectively measured~     and evaluated as indicators of normal biological processes, pathogenic processes, or~     pharmacologic responses to a therapeutic intervention (Biomarkers Defintions Working Group~     2001). Development of reliable biomarkers for PD would dramatically accelerate research on PD~     etiology, pathophysiology, disease progression and therapeutics. Specific biomarkers may be~     useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease~     progression. The biomarkers in this study include brain imaging with a radioactively labelled~     drug (Beta-CIT), computerized testing of memory, attention, motor speed, judgment and~     handwriting, and assessments of speech and smell. Subjects may also be asked to provide a~     blood sample for genetic and biochemical testing.~   "
250499|NCT00273312|"~     This study will evaluate the safety, efficacy, and activity of patupilone in patients with~     advanced unresectable and/or metastatic hepatocellular carcinoma based on tumor response~     using modified RECIST criteria.~   "
250500|NCT00273299|"~     The purpose of this study is to assess the potential of using valsartan/HCTZ as initial~     therapy in patients with severe hypertension compared to valsartan alone as initial therapy,~     and to determine whether a greater proportion of patients achieve blood pressure control with~     the combination compared to the monotherapy without producing an unacceptable adverse event~     profile.~   "
250501|NCT00273286|"~     This is a multi-center, randomized controlled trial to test whether a clinic-integrated, low~     intensity, multi-component behavioral intervention is effective in preventing the~     deterioration in glycemic control, treatment adherence, and quality of life that commonly~     occur during late childhood and early adolescence in youth with type 1 diabetes. The study~     will also examine mechanisms and processes that influence the effectiveness of family~     management of diabetes during this developmental period.~   "
250502|NCT00273273|"~     The purpose of this project is to study the pharmacokinetics of a once-daily antiretroviral~     medication used to treat adolescents and young adults with HIV infection.~   "
250503|NCT00273260|"~     The purpose of this study is to determine whether giving women feedback concerning their bone~     mineral density, combined with either an information leaflet or group education concerning~     osteoporosis changes women's behavior and/or bone density.~   "
250504|NCT00273247|"~     We conducted a randomized controlled trial of adjuvant interferon (IFN) therapy in patients~     with hepatitis-C virus (HCV)-related cirrhosis who underwent curative resection of~     hepatocellular carcinoma (HCC) to investigate whether IFN could reduce or delay the incidence~     of recurrent tumor (secondary/tertiary prevention of HCC). Patients were randomly assigned to~     treatment with IFN (3MU thrice/wk /48 weeks) vs. no treatment after curative resection of~     HCC(control group)~   "
250505|NCT00273234|"~     The purpose of this study is to compare the effectiveness of standard venous ulcer care to~     standard venous ulcer care plus a cell based product made from the patients own blood. This~     product, Autologous Platelet Concentrate (APC), is a concentrate of cells in the bloodstream~     called platelets.~   "
250506|NCT00273221|"~     The aim of this study is to compare the effectiveness and safety of combined~     phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy~     (phacotrabeculectomy) with phacoemulsification, intraocular lens implantation and glaucoma~     drainage device(phacotube) in the early and intermediate control of intraocular pressure(IOP)~     in patients with primary open angle and angle closure glaucoma.~   "
250507|NCT00273208|"~     This research project is being done to design and then test whether a 10 week program can~     help reduce the symptoms of being tired and fatigued among women who have had breast cancer.~     The pilot study will include 4 groups of women, two groups of women from Baltimore and two~     groups of women from Washington County, Maryland. Each group will have 5 to 6 women. The~     purpose of this pilot study is to help us find the best things to include in the program to~     help women who have had breast cancer and who have severe problems with fatigue that has~     lasted months to years after being treated with chemotherapy or radiation therapy.~      Following the pilot program we will conduct and evaluate (using a quasi-experimental design~     comparing fatigue scores before and after the intervention) the efficacy of the refined~     10-week integrated mind/body medicine approach to reduce symptoms of fatigue among breast~     cancer survivors who have completed their adjuvant therapy. Four intervention groups (~12~     women per group) will be conducted: two in the urban setting and two in the rural setting. We~     will assess fatigue symptoms at baseline, immediately after the program, 2 months and 6~     months following completion of the program. We will compare mean baseline scores to~     post-intervention scores.~      The ultimate goal is to develop a non-pharmacologic, holistic, low risk intervention for~     improving symptoms of fatigue and thus improving quality of life among breast cancer~     survivors~   "
250508|NCT00273195|"~     People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,~     may be in need of an electronic device called an implantable cardioverter defibrillator~     (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it~     sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm.~      The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device.~     A feature of this device allows it to send small, painless electrical impulses~     (Anti-tachycardia pacing or ATP) to the heart instead of shocking it out of a rhythm that is~     too fast. Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock~     to the heart can feel like a punch in the chest. This device also allows the heart to beat on~     its own when it can and helping it (by pacing, or sending it electrical signals) when it~     needs help. This feature is important because previously studies have shown that pacing the~     heart too often can increase the risk for heart failure or for atrial fibrillation (having~     too rapid of heart beats in the atrium).~      This study is now complete and the device has since been approved by the FDA.~   "
250509|NCT00273182|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes.~      When there are changes in the heart beat sometimes an implantable heart device is used to~     control the rate and rhythm of the heart beat. In certain heart failure cases, when the two~     lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization~     therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted)~     under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right~     and left ventricles through three or four leads (soft insulated wires) that are inserted~     through the veins to the heart.~      The purpose of this study is to monitor the long-term performance of the InSync Model 8040~     (InSync) and InSync III Model 8042 (InSync III) systems for cardiac resynchronization therapy~     (CRT).~   "
250510|NCT00273169|"~     Evaluate correlation between the values from the PSA monitor and clinical assessment of~     sedation with the RASS on postoperative patients.~   "
250511|NCT00273156|"~     The novel and exploratory nature of this intervention relates to the concept of incorporating~     patient-specific oral health information obtained during a dental hygiene visit into the~     tobacco quitline counseling. Linking the patient-specific oral health information obtained~     during the dental hygiene visit to the tobacco quitline counseling will close the therapeutic~     loop for oral health professionals and make them a focal point for the tobacco use~     intervention without increasing clinical burden.~   "
250544|NCT00272727|"~     The purpose of the study is to assess if a dialog tool can improve compliance and asthma~     control in patients with asthma.~   "
250512|NCT00273143|"~     This study is being done to determine how the body fights off a common virus known as~     Cytomegalovirus (CMV). CMV is a virus that commonly infects humans and causes disease in~     patients with compromised immune function such as those who receive organ and tissue~     transplant. By knowing how the human body responds to the infection, researchers will be able~     to develop better methods on how to prevent this infection.~   "
250513|NCT00273130|"~     Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written~     informed consent into three groups.~        1. transnasal gastroscopy with thin endoscope~        2. transoral with thin endoscope~        3. standard size trans-oral endoscopy Stress response parameters (epinephrine,~          nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were~          monitored.~   "
250514|NCT00273117|"~     Two groups of patients were randomised into two groups of either transnasal gastroscopy or~     conventional type gastroscopy (n=98). The aim of the study was to evaluate the~     cardiorespiratory effects and sideeffects of the two methods, and to evaluate the technical~     features of the transnasal endoscope.~   "
250515|NCT00273104|"~     This follow up study (>1 year) aims to compare the effects of lifestyle intervention and~     gastric by pass surgery on various comorbidities associated with morbid obesity.~   "
250516|NCT00273091|"~     Detektion and Registration of Atrial Tachyarrhythmias at Patients with Heart Failure; What~     proportion of patients with CRT-therapy are affected at least temporarily by Atrial~     Arrhythmia?~   "
250517|NCT00273078|"~     This research is about tongue’s pressure during speech, using a complete denture which allows~     respecting tongue and speech physiology at the best.~      A strain gauge transducer is placed inside this prosthodontics device. During speech, the~     pressure and the sounds are recording. The analysis of the twos signals should explain what~     pressure is needed for what sound. The comparison between old complete denture wearers and~     new one is realized to provide informations about tongue adaptation’s phenomenon.~   "
250518|NCT00273065|"~     The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in~     humans~   "
250519|NCT00273052|"~     This study was designed to determine whether treatment with COREG MR is more effective at~     maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.~   "
250520|NCT00273039|"~     The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in~     subjects with Social Anxiety Disorder~   "
250521|NCT00273026|"~     This study will compare patients treated with a marketed medication and those who continue~     with their usual care to assess the proportion of patients achieving well controlled asthma~     after 24 weeks.~   "
250522|NCT00273013|"~     This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect~     on a model of asthma type inflammation called the allergen-induced late asthmatic response.~     This will be compared with the response after treatment with a dummy (placebo) and a tablet~     treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3~     treatments in a random order. The study is double-blind so subjects will not know which~     treatment they are taking at any given time.~   "
250523|NCT00273000|"~     The purpose of this study is to study the effect of GLP-2 on mesenteric bloodflow in healthy~     adults by the use of ultrasound., it is the hypothesis that GLP-2 vil increase the bloodflow.~   "
250524|NCT00272987|"~     Patients will be randomised to a 1:1 ratio to receive either paclitaxel 80 mg/m2 IV weekly~     for three weeks of a four week cycle, trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly IV,~     and oral lapatinib 1000 mg QD or paclitaxel 80 mg/m2 IV weekly for three weeks of a four week~     cycle, trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly IV plus placebo. The primary~     objective of this study is to evaluate and compare time to progression (TTP). Secondary~     objectives will be to evaluate and compare the two treatment arms with respect to: overall~     response rates, clinical benefit, time to response, duration of response, progression-free~     survival, and overall survival. The study will first enroll an open label safety cohort of 20~     patients to assess the tolerability of the triplet combination.~   "
250525|NCT00272974|"~     The study was designed to measure the effects of male and female condom promotion on STI~     prevalence and reported condom use by sex workers and their partners. It also examined~     whether the intensity of the education and support given to intended users affected adoption~     and sustained use of these methods.~      The primary objective of the study was:~        1. To test the effect of supplementing community-based male and female condom promotion~          with clinic-based counseling, measured in terms of the level of protection in high-risk~          sex acts and STI prevalence.~           Secondary objectives of the study included:~        2. To monitor short- and medium terms changes in the proportion of protected sex acts among~          commercial sex workers after the female condom is added to a male condom distribution~          system.~        3. To examine short-term and medium-term changes in STI prevalence when the female condom~          is added to the male condom distribution system.~        4. To measure the incremental cost-effectiveness of adding female condom promotion to~          existing male condom distribution systems~   "
250526|NCT00272961|"~     The study was to determine the safe and effective dose of TBC3711 in patients with~     uncontrolled high blood pressure while already taking blood pressure medications.~   "
250527|NCT00272948|"~     The aim of this trial is to evaluate whether the prophylactic use of Defibrotide (DF) in~     pediatric patients (age less than 18 years) undergoing stem cell transplantation and who are~     at high risk of developing hepatic Veno-occlusive Disease (VOD) will have an impact on the~     incidence and severity of the disease. Patients will be randomly assigned to one of two~     treatment arms: Those allocated to the Prophylactic Arm will receive the study drug~     (Defibrotide) from the day of conditioning onwards. Patients allocated to the Control Arm~     will receive the study drug (Defibrotide) from the day that VOD is diagnosed.~   "
250528|NCT00272935|"~     This is a randomized, double-blind study to compare the efficacy and safety of daily doses of~     Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to~     severe hot flashes in postmenopausal women.~   "
250529|NCT00272922|"~     The purpose of this randomized study is to determine whether a type of mesh derived from a~     layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus~     standard surgical suture repair.~   "
250530|NCT00272909|"~     This research study is designed to evaluate the safety, tolerability, and efficacy of SUN~     N4057 (piclozotan) in subjects with acute ischemic stroke within 9 hours of the onset of~     symptoms.~   "
250531|NCT00272896|"~     We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that~     VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To~     test this hypothesis, we performed a double blind placebo-controlled crossover study in~     migraineurs and studied the effect on headache and cerebral and systemic hemodynamic~     parameters.~   "
250532|NCT00272883|"~     In the Congenital Myopathy Research Program at Boston Children's Hospital and Harvard Medical~     School, the researchers are studying the congenital myopathies (neuromuscular diseases~     present from birth), including central core disease, centronuclear/myotubular myopathy,~     congenital fiber type disproportion, multiminicore disease, nemaline myopathy, rigid spine~     muscular dystrophy, SEPN1 and RYR1 myopathy and undefined congenital myopathies. The primary~     goal of the research is to better understand the genes and proteins (gene products) involved~     in muscle functioning and disease. The researchers hope that our studies will allow for~     improved diagnosis and treatment of individuals with congenital myopathies in the future. For~     more information, visit the Laboratory Website at www.childrenshospital.org/research/beggs~   "
250533|NCT00272870|"~     Cure rates for patients with high grade glioma remain disappointing, in part because tumor~     cells are often resistant to chemotherapy, and because using higher doses of chemotherapy~     causes damage to normal blood cells. This trial is designed to try to overcome both of these~     barriers. The idea is to make tumor cells more sensitive to a chemotherapy agent,~     Temozolomide, by using 06Benzylguanine (06BG). In addition, patients will have a portion of~     their blood cells modified by the insertion of a chemotherapy resistance gene which may help~     protect blood cells from damage by the combination of the Temozolomide and 06BG.~   "
250534|NCT00272857|"~     Fanconi anemia (FA) is a disease that affects an individual's bone marrow. It is caused by a~     defective gene in the bone marrow cells that produce various types of blood cells.~     Individuals with FA may experience fatigue, bleeding, and increased infections. The purpose~     of this study is to evaluate the safety and effectiveness of a gene transfer procedure in~     generating new, healthy cells in individuals with FA.~   "
250535|NCT00272844|"~     The purpose of this study is to determine whether supplementation with an oil-based~     cholesterol suspension will correct the biochemical abnormalities in cholesterol and its~     precursors in individuals with the Smith-Lemli-Opitz syndrome.~   "
250536|NCT00272831|"~     Patients with type 2 diabetes have a long duration of disease for the development of~     complications. Among all complications, microangiopathic complications are major causes of~     mortality and morbidity in diabetic patients. In Asia, patients with type 2 diabetes are~     particularly susceptible to the development of kidney disease. Patients with diabetic kidney~     disease have more adverse metabolic profiles and increased risk of having other complications~     such as blindness, stroke, heart attack and nerve damage than those without. Despite~     receiving the best of care, the combined event rate of death, cardiovascular disease and end~     stage kidney disease in diabetic patients with renal impairment remained as high as 10% per~     year.~      Cilostazol reduces platelet aggregation and prevents formation of blood clots. Furthermore,~     cilostazol treatment has been shown to reduce serum triglyceride concentrations and increase~     HDL-cholesterol levels. In this randomized placebo-controlled, double-blinded study, the~     investigators hypothesize that Cilostazol may reduce the rate of decline in renal function in~     Chinese patients with type 2 diabetes and mild to moderate renal impairment. Sixty patients~     will be randomised to receive either Cilostazol 100 mg twice daily or placebo for 12 months.~     The effect of Cilostazol on the progression of diabetic nephropathy, as defined by rates of~     decline in glomerular filtration rate, serum creatinine and urinary albumin excretion rate~     will be measured. The results will provide additional insight on the management of diabetic~     kidney disease which is prevalent among Chinese diabetic patients in Hong Kong.~   "
250537|NCT00272818|"~     The incidence of gastrointestinal allergy is on the rise and can be manifest in a number of~     different clinical presentations. The goal of this study is to evaluate the measurement of~     CD23, a protein that can be identified stool, urine, and blood, as a non-invasive marker for~     use in the diagnosis and interval assessment of patients with known or suspected~     gastrointerstianl allergy.~      Eosinophilic esophagitis (EE) is a disorder typically found in school-age and adolescent~     children, and is more prevalent in male patients. Patients with EE typically present with~     symptoms of heartburn or difficulties swallowing. Blood and x-ray studies may be normal or~     display non-specific findings. The diagnosis of EE rests on a combination of clinical~     symptoms, and the results of endoscopic and histologic studies. There is currently no~     biochemical marker that can be used to monitor disease course in these patients.~      Cow milk protein intolerance (CMPI) is an allergic process affecting the distal~     gastrointestinal tract in infants. As such, it often presents as diarrhea without or without~     the presence of gross rectal bleeding in infants ranging in age from birth to 6 months of~     age. Children display symptoms of abdominal disress including emesis, cramping, colic, or~     feeding difficulties. The diagnosis is based on an appropriate clinical history and~     supporting physical exam (typically normal). Treatment involves removal of the offending~     dietary antigens which include cow or soy milk protein Eosinophilic crypt abscesses, or~     collections of eosinophils within the intestine can also be seen.~      CD23 is a protein that can be found on allergy-type white blood cells (eosinophils), as well~     as on the cells that line the gastrointestinal tract. Previous studies have reported~     increased levels of CD23 in infants with cow's milk allergy. CD23 is also elevated in infants~     and children with allergic disease. Levels of CD23 appears to fall in conjunction with~     therapy.~   "
250538|NCT00272805|"~     The purpose of this study is to compare dosing compliance between study patients taking~     controlled release carvedilol once a day, and study patients taking immediate release~     carvedilol (Coreg) twice a day.~   "
250539|NCT00272792|"~     The primary objective of this trial is to evaluate the ability of Phenoptin to increase~     phenylalanine (phe) tolerance in children with phenylketonuria who are following a~     phe-restricted diet.~   "
250540|NCT00272779|"~     The purpose of this study is to evaluate the safety, tolerability and antiviral effects of~     atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV.~     A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by~     participants in both arms.~   "
250541|NCT00272766|"~     The purpose of this study is to evaluate the safety and effect on visual acuity of Macugen~     (pegaptanib sodium) in patients with subfoveal choroidal neovascularization (CNV) secondary~     to the ocular histoplasmosis syndrome (OHS).~   "
250542|NCT00272753|"~     The aim is to study whether the budesonide component within the budesonide/ formoterol~     combination inhaler has additive value in a model of slow onset acute asthma , namely three~     AMP provocation tests performed on one day~   "
250543|NCT00272740|"~     The primary objective of the study is to assess the activity of fulvestrant in postmenopausal~     women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase~     inhibitors by estimating the Clinical Benefit Rate~   "
250545|NCT00272714|"~     The purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen~     (4-OHT) compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women~     with regular menstrual cycles who are not taking oral contraceptives.~   "
250546|NCT00272701|"~     The purpose of this study is to assess how PPI treated GERD patients with insufficient~     symptom control will benefit from a change in management by providing a more efficient acid~     secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to~     pre-study PPI treatment.~   "
250547|NCT00272688|"~     An open, observational health economic study to estimate marginal cost and health~     consequences of replacing conventional Parkinsons disease therapy with intraduodenal levodopa~     administered continuously~   "
250548|NCT00272675|"~     Does chlorhexidine gluonate, a simple broad-spectrum antimicrobial agent with virtually no~     adverse-effects lower the incidence of NI after cardiac surgery, especially with respect to~     LTI and SSI?~   "
250549|NCT00272662|"~     The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and~     pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in~     anemic cancer participants receiving chemotherapy.~   "
250550|NCT00272649|"~     The purpose of this trial is to examine the safety, feasibility, immunological response, and~     clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic~     to patients with newly diagnosed with metastatic kidney cancer~   "
250551|NCT00272636|"~     The purpose of this study is to determine the long-term efficacy of radiofrequency catheter~     ablation in patients with chronic atrial fibrillation.~   "
250552|NCT00272623|"~     Since the first placement of a totally implantable venous access port (TIVAP) by Niederhuber~     et al in 1982 its application to provide long-term central venous access has dramatically~     increased. These systems have dramatically simplified the administration of chemotherapy and~     parenteral nutrition as well as the repetitive collection of blood samples.~      Initial retrospective studies have focused on the complications associated with different~     implantation techniques. Subsequently, major attention has been payed to the comparison of~     distinct types of TIVAPs. To date a variety of approved port systems are available. These~     devices can be either implanted using the Seldinger technique or by venous cut-down of the~     cephalic vein Despite the global use of these established implantation procedures~     prospective, randomized trials directly comparing these two approaches are still lacking. So,~     the choice, which technique to use is left to the surgeon's preference.~      The aim of this study is to directly compare the Seldinger technique versus cephalic vein cut~     down for placement of TIVAPs in respect of implantation success rate, operation time and~     perioperative morbidity.~   "
250553|NCT00272610|"~     The objectives of this study are to evaluate the safety and efficacy of 0.5% retinol (Vitamin~     A) versus it's vehicle cream in the treatment and prevention of skin aging and Bateman's~     Purpura (bruising).~   "
250554|NCT00272597|"~     The primary objective of this pilot study is to evaluate the impact of switching 30 subjects~     from an existing antipsychotic to risperidone long acting on healthcare resource utilization.~     The study will be a ten month open-label, 'mirror-image', pilot study. Healthcare resource~     utilization during the 10 months prior to starting risperidone long acting will be~     retrospectively collected for all subjects (period A) at the beginning of the study. The~     utilization of direct medical resources will also be collected for 10 months after initiation~     of risperidone long acting (period B). In this design the patients will serve as their own~     control.~   "
250555|NCT00272584|"~     This is a 9 week, multicentre, randomized, double-blind, placebo-controlled trial with two~     parallel groups. There is also an open-label extension phase of 18 weeks. Both medications to~     be used in the study, clozapine and risperidone, are fully approved for the treatment of~     schizophrenia.~   "
250556|NCT00272571|"~     The objectives of the study are to test the hypothesis that external counter pulsation~     therapy (ECPT) provides clinical benefit by improving the number and function of endothelial~     progenitor cells (EPCs) in peripheral blood of patients with angina pectoris.~   "
250557|NCT00272558|"~     The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly~     orally and partly intravenous in advanced pleural mesothelioma.~   "
250558|NCT00272545|"~     This study will evaluate the effectiveness of a new approach to a normalization of eating~     program, based on principles of cognitive-behavioral therapy, in treating women with anorexia~     nervosa or bulimia nervosa.~   "
250559|NCT00272532|"~     Study objective:~        -  To demonstrate, in patients with myofascial pain syndrome in cervical region, the degree~          of efficacy of thiocolchicoside ointment administered to trigger point regions compared~          with the trigger point injection.~   "
250560|NCT00272519|"~     The life skills intervention model is designed to help adolescents promote their physical and~     mental health through cognitive and behavioral techniques (e.g., problem solving, coping, and~     communication skills) designed to help them achieve social and personal competencies used to~     manage various life challenges.~   "
250561|NCT00272506|"~     To evaluate current and novel therapies and management strategies for children with asthma.~     The emphasis is on clinical trials that help identify optimal therapy for children with~     different asthma phenotypes, genotypes, and ethnic backgrounds and children at different~     developmental stages.~   "
250562|NCT00272493|"~     Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a naturally occurring substance~     that is made by the body in response to infection or inflammation, and greatly improves~     cellular immune responses. The purpose of this study is to evaluate the safety and~     effectiveness of GM-CSF as an adjuvant to improve the immune response to hepatitis B virus~     (HBV) vaccination in HIV infected individuals.~   "
250563|NCT00272480|"~     To determine whether the use of two antiviral agents in combination will be better than~     placebo in the treatment of an inflammatory sidease of the spinal cord caused by HTLV-I~   "
250564|NCT00272467|"~     The purpose of this study is to evaluate the ulcer healing efficacy of rebamipide in~     comparison with omeprazole in Helicobacter pylori-positive gastric ulcer after eradication~     therapy.~   "
250565|NCT00272454|"~     The purpose of this study is to study efficacy and safety of cilostazol use in patients with~     acute ischemic stroke.~   "
250566|NCT00272441|"~     To evaluate current and novel therapies and management strategies for children with asthma.~     The emphasis is on clinical trials that help identify optimal therapy for children with~     different asthma phenotypes, genotypes, and ethnic backgrounds and children at different~     developmental stages.~   "
250567|NCT00272428|"~     It has been suggested that a low dietary intake of antioxidant vitamins and minerals~     increases the incidence rate of cardiovascular disease and cancer. To date, however, the~     published results of randomized, placebo-controlled trials of supplements containing~     antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the~     efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins~     and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the~     general population.~   "
250568|NCT00272415|"~     This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen~     (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma.~     A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed~     enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.~   "
250569|NCT00272402|"~     In this randomized trial we evaluate two conceptually distinct but potentially synergistic~     interventions designed to reduce clinical inertia in the outpatient care of adults with type~     2 diabetes. The project addresses the following specific aims;~      Specific Aim 1. Implement and assess two conceptually distinct but potentially synergistic~     interventions to reduce clinical inertia related to control of A1c, SBP, and LDL in adults~     with diabetes.~        -  Hypothesis 1. Patients of physicians who receive the Cognitive Behavioral Intervention~          (CBI) (Group 1) will subsequently have less Clinical Inertia than those who receive no~          intervention (Group 4).~        -  Hypothesis 2. Patients of physicians who receive the Office Systems Redesign~          intervention (CBI) (Group 2) will subsequently have less Clinical Inertia than those who~          receive no intervention (Group 4).~        -  Hypothesis 3. Patients of physicians who receive the combined CBI plus OSR intervention~          (Group 3) will subsequently have less Clinical Inertia than those who receive CBI alone~          (Group 1) or OSR alone (Group 2).~      Specific Aim 2. Assess the impact of interventions to reduce clinical inertia on health care~     charges.~      • Hypothesis 4. After adjustment for baseline measures of health care charges, those who~     receive no intervention (Group 4), will have higher total health care charges over a 24-month~     follow-up, relative to the patients of physicians in intervention Group 1, Group 2, or Group~     3.~   "
250570|NCT00272389|"~     We hypothesized that pretreatment nonresponder and responder liver tissue would show~     consistent differences in gene expression levels and that these differences could be used to~     predict treatment outcomes and this can obviate the need of the present therapeutic trial.We~     are interested in conducting a retrospective study using the data of patients suffering from~     chronic HCV infection who were treated in our department with a combination of PEGINTERFERON~     and RIBAVIRIN. All these patients underwent liver biopsy prior the treatment. Based on the~     clinical data available it is possible to determine the responders and nonresponders to this~     therapy.RNA will be extracted from the liver tissue and the expression of 5~     genes(IFI15,IFI616,IFI1,OAS3,OAS2 )will be checked .The prediction power of the combination~     of these genes in differentiating responders from nonresponders will be determined.~   "
250571|NCT00272376|"~     This study will examine the inheritance of myopia in families of various nationalities and~     ethnic backgrounds to identify gene changes that cause myopia or similar diseases and to~     better understand these conditions. In patients with myopia, the eye does not focus light~     accurately on the retina (tissue that lines the back of the eye), so that objects at a~     distance appear blurry. Myopia may occur alone, with other vision problems such as retinal~     dislocations, cataract or glaucoma, or with other problems such as joint or skin problems.~      People with myopia (usually those from families with several affected members) and control~     subjects with normal vision may be eligible for this study.~      Each participant undergoes the following procedures:~        -  Blood draw for genetic testing related to the disorders under study~        -  Medical and family history, including drawing a family tree to explore vision problems~          in the family~        -  Complete eye examination, including refraction (pupil dilation) and visual acuity~          testing, photographs of the retina and possibly lens, and specialized tests to measure~          field of vision, color vision and ability to see in the dark~   "
250572|NCT00272363|"~     This study will document the clinical and genetic features of glaucoma and related diseases,~     including normal tension glaucoma (NTG). Researchers would like to define genetic influences~     and eventually isolate the genes causing those diseases.~      Glaucoma is an important cause of vision loss in the United States and worldwide. The disease~     is marked by a wearing down of the retina and optic nerve, often associated with increased~     pressure in the eye. It is often an inherited trait. This study will involve between 250 and~     2,000 patients over a 5-year period. It will examine the natural history of the genotype, or~     genetic makeup, of a person and the phenotype, that is, visible situations produced by the~     interaction of the genotype and one's environment.~      Patients 4 and older who have glaucoma or related diseases or whose family members have those~     diseases may be eligible for this study. They will complete a medical history for the doctors~     to verify the diagnosis, inquire about medical problems and surgical operations, and gather~     data about vision problems in a patient's family (by drawing a family tree). The complete eye~     examination may take several hours. Eye drops will be used to dilate, or enlarge, the pupils~     of patients' eyes, and the pupils will stay dilated for 4 to 6 hours. There may be some~     temporary glare in brightly lit areas, which can be reduced by wearing of sunglasses.~     Patients may experience some blurring of vision. There may be a localized allergic reaction~     to the medication used or an increase of pressure inside the eye. If that occurs, medication~     to control the reaction will be given. In addition, photographs of the retina and perhaps~     even the lens will be taken. For that procedure, eye drops will dilate the pupils of the~     eyes. The light that is involved with the specialized photography may cause some mild~     discomfort. Patients will undergo eye tests regarding color vision, field of vision, and~     ability to see the dark. Also, there will be a measurement of pressure in the eye and~     thickness of the cornea.~      To study patients' DNA, the researchers will obtain a blood sample of about 4 teaspoons from~     patients 10 years or older. A smaller amount of about 1 teaspoon for each 5 lb. of body~     weight will be collected from younger patients. Those DNA samples will be used only for~     research in the genetic disorder in a patient's family. No other testing or research will be~     conducted on the blood samples without patients' separate permission. Also, the DNA will be~     stored by codes that the researchers define and contained in a secured building.~      In this study, researchers will not provide information about a patient's health to patient~     family members or to other people. They will not discuss information such as adoption or~     biological fatherhood unless it has medical implications for the patient or the patient's~     family members.~      If information obtained from this study may be important to patients' health, they will be~     informed when it is available. There are no plans to give patients the results of any medical~     tests, evaluations, or other research data. Further research may be needed before such~     results become meaningful.~   "
250573|NCT00272350|"~     Background:~      In vivo experiments have documented the ability of ZD6474 to inhibit tumor growth in various~     preclinical tumor models. Given the pronounced neovasculature associated with malignant~     gliomas, and abundant published data demonstrating the dependence of glioma growth on the~     maintenance and proliferation of this neovasculature, ZD6474 represents a potentially~     promising new therapeutic approach to these otherwise refractory tumors.~      Thus, we now propose a phase I trial of ZD6474 in patients with recurrent and progressive~     low-grade gliomas who are on P450-inducing anti-epileptic drugs and a phase II trial for~     patients with recurrent gliomas not taking P450-inducing anti-epileptic drugs.~      Objective:~      Phase I - To establish the maximally tolerated dose of ZD6474 and to obtain preliminary~     information regarding the spectrum of toxicities of ZD6474, and to obtain pharmacokinetic~     data to patients taking EIAED.~      Phase I - To obtain preliminary information regarding potential anti-tumor activity of ZD6474~     in patients taking EIAED.~      Phase II - To establish data regarding the anti-tumor activity of ZD6474 and to collect~     information regarding the spectrum of toxicities in patients not taking EIAEDs.~      Eligibility:~      Patients with histologically proven malignant primary gliomas will be eligible for this~     protocol. Additionally, patients with progressive low-grade gliomas and patients with~     infiltrative brain stem gliomas, diagnosed radiographically rather than by biopsy will also~     be eligible.~      Design:~      Phase I - Group B patients will be accrued to the formal dose-escalation phase I trial.~     Groups of patients with recurrent high-grade gliomas will be accrued to increasingly higher~     doses of ZD6474 until the MTD is established.~      Phase II - Patients will be treated at a dose of 300 mg day, every day, on a 4-week cycle.~   "
250574|NCT00272337|"~     The purpose of the study is to test higher versus lower doses of aspirin on markers of~     atherosclerosis in patients who have had a heart attack.~   "
250575|NCT00272324|"~     This is a randomized controlled trial of aspirin and/or folate supplementation for the~     prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.~   "
250576|NCT00272311|"~     The purpose of the study is to test higher versus lower doses of aspirin on markers of~     atherosclerosis in patients at risk of a first heart attack.~   "
250577|NCT00272285|"~     The purpose of this study is to compare the efficacy and safety of ramosetron plus~     dexamethasone injection with granisetron plus dexamethasone injection for the prevention of~     chemotherapy-induced vomiting and nausea.~   "
250590|NCT00272103|"~     This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the~     treatment of patients with functional dyspepsia.~      The study will test in patients with functional dyspepsia the hypothesis that itopride is~     superior to placebo with regard to the improvement of symptoms.~   "
250578|NCT00272272|"~     Falls are the largest cause of death in the elderly and those with dementia have even a~     higher incidence of falling. The purpose of this study is to determine whether listening to~     the Music of Nolwenn Leroy is effective in fall prevention in those elderly patients who are~     residents in a Geriatric Nursing Home Facility. The music of Nolwenn Leroy has been shown to~     be effective in fall reduction in a different setting (Posturographic Changes and Fall~     Prevention associated with Music Therapy: The Nolwenn Effect (USA ClinicalTrials.gov~     Identifier: NCT00121693) )with results better than listening to Mozart of any other music.~   "
250579|NCT00272259|"~     The investigators are looking for individuals who have suffered a stroke to participate in an~     experiment examining the use of robotics in rehabilitation. They are trying to develop a~     robotic environment for hands after having had a stroke. Participants will interact with up~     to two small robots and a visual display. The experiment involves minimal risk and may~     involve testing sessions over multiple weeks. Subjects must be at least 1 year post-stroke~     and have difficulty picking up small objects.~      For more information, contact: Bambi Brewer, CMU Ph.D. Student, 412-241-9423 or~     bambi@andrew.cmu.edu.~   "
250580|NCT00272246|"~     Primary generalized dystonia, also called idiopathic torsion dystonia or dystonia musculorum~     deformans is a disabling neurological condition which usually starts in childhood, mostly in~     a lower limb and spreads to other body parts as the disease progresses. Medical treatment is~     usually ineffective and most patients become wheelchair bound or even bedridden. Recently~     several case series and one RCT reported favourable results of bilateral deep brain~     stimulation (DBS) of the globus pallidus internus (GPi) for primary generalized dystonias.~     However, the number of patients treated with bilateral GPi stimulation is still limited.~     Therefore, we propose a RCT to investigate whether bilateral DBS of the GPi is an effective~     and safe treatment in patients with primary generalized dystonia.~   "
250581|NCT00272233|"~     Work requirements for medical trainees result in substantial sleep loss. Sleep loss has been~     associated with increased levels of certain inflammatory hormones that could have negative~     impact on blood vessel function. The purpose of this study is to determine the effects of~     sleep loss on blood hormone levels and blood vessel function in medical trainees.~   "
250582|NCT00272220|"~     Our study is a randomized controlled trial that aims to evaluate the effectiveness of~     modified directly observed therapy (mDOT) to (1) increase both short and long term adherence~     to HAART treatment, and (2) improve clinical outcomes associated with HAART therapy.~      Our hypothesis is that modified directly observed therapy (mDOT) during the initial 6 weeks~     of HAART, supervised primarily by HIV-positive lay activists, will improve adherence and~     clinical outcomes compared with those that do not have supervised mDOT. We also hypothesize~     that the benefits of mDOT will be achieved through a variety of mediators that will result~     from the social interactions the patients will have with the activists. These mediators~     include improved social support, improved knowledge about HAART, reduced stigma, and improved~     self-efficacy.~   "
250583|NCT00272207|"~     The purpose of the study is to determine whether or not the drug Nabilone significantly~     reduces pain and improves quality of life in patients with fibromyalgia.~   "
250584|NCT00272194|"~     The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an~     intubation conduit for endotracheal intubation.~   "
250585|NCT00272181|"~     The purpose of this study is to determine the safety, effectiveness, and recommended dose of~     Proxinium in North American patients with Squamous Cell Head and Neck Cancer~   "
250586|NCT00272168|"~     The goal of this study is to evaluate the efficacy of a combined social skills training and~     cognitive-behavioral therapy intervention for seriously mentally ill Veterans as they begin~     employment.~   "
250587|NCT00272155|"~     This study will explore the possible effect of a tailored educational intervention towards~     general practitioners, in order to improve antibiotic prescriptions for respiratory~     infections.~   "
250588|NCT00272142|"~     There are currently no interventions available to substantially reduce the incidence of low~     birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation~     and possibly improved energy intakes.~      The current view of the medical and public health community in India is that the immediate~     focus should be on promoting survival and development of low birth weight infants who have~     nearly a 6 to 7 fold higher mortality during infancy than those with normal birth weight.~      Low serum zinc is associated with increased incidence of diarrhea and pneumonia. There is~     sufficient evidence in under-threes that during acute illness, zinc supplementation (1-2~     recommended dietary allowance [RDA]) reduces incidence of all episodes of diarrhea, severe~     diarrhea and pneumonia. A number of initial published trials also show significant effect of~     zinc treatment on pneumonia. With the large and consistent effects of zinc supplementation on~     the incidence and severity of infections, an effect on child mortality is likely.~      Available literature suggests the distinct possibility of reduced neonatal and infant~     mortality in LBWs receiving 1 RDA of zinc daily. A pilot study in India showed a 54%~     reduction in mortality in LBW infants. These findings were based on a very small sample and~     therefore considered insufficient to change policy.~      A positive impact in the proposed study will provide an important tool for reduction of~     infant mortality which is currently stagnant and government acceptance for such a program is~     likely to be very high. We, the researchers at the Society for Applied Studies, believe this~     study has the potential for decreasing infant mortality from its current level.~   "
250589|NCT00272116|"~     Zinc deficiency is common in developing country children, as food intakes are often low,~     foods from animal sources are infrequently used, the bioavailability of zinc from staple~     cereal-based diets is limited and zinc losses occur during recurring diarrheal illnesses.~     Zinc deficiency is associated with impairment in immunological and other defenses against~     infection and increased rates of serious infections. Due to limitations in currently used~     biochemical markers, supplementation trials in populations likely to be deficient provide a~     reliable means of assessing health consequences of zinc deficiency.~      A significantly lower incidence and prevalence of diarrhea has been observed in zinc~     supplemented developing country children in several placebo-controlled trials. The effect of~     routine zinc supplementation on lower respiratory tract infection is still unclear. We,~     therefore, evaluated the impact of daily zinc supplementation in a representative sample of~     children aged 6 to 30 months enrolled from a New Delhi slum area, with a sample size~     sufficient to determine the impact on the incidence of severe diarrhea and acute lower~     respiratory infection.~   "
250591|NCT00272090|"~     The primary purpose of the protocol is to demonstrate that the new regimen (insulin~     glargine+regular insulin ) is no worse than the reference regimen (insulin glargine+lys-pro~     insulin ) in reducing the incidence of severe nocturnal hypoglycemia at the end point; the~     secondary purpose is to compare the two study regimens as far as the glycemic control~     (measured by HbA1c), the daily Mean Blood Glucose (MBG) and the mean amplitude of glycemic~     excursion (MAGE index), calculated on the basis of Self Monitoring Blood Glugose (SMBG) data,~     are concerned and to verify the safety of basal insulinization with Lantus.~   "
250592|NCT00272077|"~     Primary objective:~      To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability~     (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose).~      Secondary objectives:~      The secondary objectives are the assessment of: changes in glycaemic control (HbA1C),~     frequency of hypoglycaemias, changes in weight, final insulin dose, changes in lipid~     parameters, changes in urinary albumin-to-creatinine ratio, profile of patient which best~     fits each of the algorithms with the dependent variable of change in HbA1C and independent~     variables of age, gender, race, tobacco use, diabetes complications, initial HbA1C, initial~     weight, duration of diabetes mellitus, general education and diabetes education.~   "
250593|NCT00272064|"~     -  The primary objective of the present study is to verify the superiority of Telecare~          program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point.~        -  The secondary objectives of the study are the assessment of: total daily dose of~          insulin, changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in~          weight, health-related quality of life, cost-effectiveness of Telecare program vs.~          common ambulatory program; general safety (adverse event profile, other routine~          laboratory parameters).~   "
250594|NCT00272051|"~     Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity~     of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal~     carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory~     neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo~     group ; Compare the response rate between treatment group and placebo group.Secondary~     objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to~     recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free~     survival, overall survival) ; safety profile.~   "
250595|NCT00272038|"~     Objectives to evaluate the activity of Erlotinib in prostate cancer patients who are hormone~     refractory and androgen independent and have not been exposed to chemotherapy.~   "
250596|NCT00272025|"~     To determine if adding Escitalopram to current mood stabilizer (MS) or atypical antipsychotic~     (AA) will improve in rates similar to or better than adding a placebo (inactive pill)in~     resistant bipolar patients.~   "
250597|NCT00272012|"~     Primary objective:~      The primary study objective is to compare efficacy of Insulin glulisine, once a day at~     breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin~     glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual~     patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy~     regimens receiving two different injection timing of Insulin glulisine.~      Secondary objective:~      Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a~     day at breakfast vs. Insulin glulisine given once a day at main meal in combination with~     insulin glargine + OAD in terms of:~        -  Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose~          (baseline to endpoint)~        -  Change of fasting plasma glucose (baseline to endpoint)~        -  Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study~          endpoint~        -  Insulin dose (rapid-acting, basal and total daily doses)~        -  Weight, body-mass index~        -  Hypoglycemic events~        -  Adverse events~   "
250598|NCT00271999|"~     The Frequent Hemodialysis (FHN) Nocturnal Trial is a randomized controlled trial recruiting~     subjects from dialysis units associated with designated Clinical Centers in the U.S. and~     Canada and followed for 12 months. Subjects will be randomized to conventional hemodialysis~     delivered three days per week home arm or to the six times per week nocturnal home~     hemodialysis arm which will follow any dialysis prescription provided their prescribed~     standardized Kt/V is at least 4.0 and treatment time is at least 6.0 hours, six times per~     week.~   "
250599|NCT00271986|"~     Anastomotic leakage is a serious complication after LAR with high morbidity and mortality~     rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to~     investigate the clinical use of peritoneal microdialysis and whether is able to detect~     anastomotic leakage prior to clinical symptoms develops.~   "
250600|NCT00271973|"~     Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days~     receive Oxycodone 20 mg po vs. placebo. Half of the volunteers will be poor metabolizers~     according to CYP2D6 genotype and half will be extensive metabolizers (EM) and have an enzyme~     with normal function. The study hypothesis is that PM will experience less pain relief than~     EM.~   "
250601|NCT00271960|"~     This study will determine the effectiveness of two group prenatal care programs as compared~     to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes~     in young women during and after pregnancy.~   "
250602|NCT00271947|"~     Crohn's disease (CD) is a chronic illness, immunologically mediated, probably induced by the~     exposure of the intestine to an antigen or antigens similar to the intestine, to which~     immunologic tolerance is lost or a dysregulated immunity ensues. The disease has a variable~     course, from a mild, intermittently active illness requiring only symptomatic therapy to a~     fulminant illness requiring potentially dangerous immunosuppressive therapy, surgery or both.~     The molecular defect causing CD has not been characterized, but probably involves aberrant T~     cell function. Although CD often responds to immunosuppressive medication including~     corticosteroids, azathioprine and 6-mercaptopurine, to anti inflammatory drugs such as 5~     aminosalicylate (5 ASA), or to some antimicrobial agents, including metronidazole, no therapy~     has been curative. In patients with severe CD, who have been unresponsive to corticosteroids,~     azathioprine, 5 ASA, metronidazole, and infliximab, we propose to compare the efficacy of~     Crohn's disease non-myeloablative autologous hematopoietic stem cell transplantation (CDNST)~     to standard therapy. Subsequent disease activity will be followed by (1) Crohn's disease~     activity index (CDAI), (2) a more global severity index, the Crohn's Severity Index, (3) type~     and amount of therapy for CD, and (4) clinical, hematologic and biochemical studies.~   "
250604|NCT00271921|"~     The purpose of this study is to examine whether body fat distribution changes that occur with~     weight gain in women recovering from anorexia nervosa are transient or persistent, and if~     they are associated with other features of Metabolic Syndrome.~   "
250605|NCT00271908|"~     During Phase III, Adolescent Trials Network for HIV/AIDS Interventions~     (ATN)/Connect-to-Protect (C2P) site staff, their official community partners established in~     Phase I, and newly invited community sector representatives (i.e., individuals from various~     key parts of the community such as family, spiritual or faith-based institutions, business~     and government) will form a coalition that will work toward achieving C2P objectives. ATN~     040b is the evaluation protocol for ATN 040, Phase III of C2P.~   "
250606|NCT00271882|"~     This is a qualitative study using a purposive sampling methodology to interview HIV-positive~     female adolescents who have experienced physical and/or sexual abuse. An open-ended, in-depth~     interview, occurring over one to two sessions, will be conducted with each participant.~   "
250607|NCT00271869|"~     Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic~     stem cell transplantation and the leading cause of death more than 2 years after~     transplantation.During the past 30 years survival of patients with chronic GVHD has not~     improved and steroids remained the most often used therapy. Extracorporeal photoimmunotherapy~     (ECP)has shown to be efficacious in patients with GVHD. We propose a phase II study to~     evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly~     diagnosed chronic GVHD of liver or lungs and need for systemic immunosuppression defined~     according to the NIH consensus criteria.~   "
250608|NCT00271856|"~     To examine the effects of Mindfulness-Based Stress Reduction (MBSR) and education groups on~     HIV (Human Immunodeficiency Syndrome) infection. Key outcomes include CD4 and viral load,~     stress hormones, depression and quality of life.~   "
250609|NCT00271843|"~     This study evaluates multi-attribute utility, a modification of subjective expected utility,~     as a descriptive model of the adolescent's decision to initiate smoking or alcohol use.~     According to the model, the young decision maker envisions a set of consequences that will~     follow the two decision options, either to continue as a non-user or to initiate usage. Each~     consequence has three components. The components are the worth of the consequence, which may~     be positive or negative, the judged likelihood that the consequence will happen, and the~     importance of the consequence. Within an individual, importances will change with mood or~     circumstance, which is how the model accounts for impulsive decisions that may occur in~     social settings.~      The model will be tested by eliciting components of ten independent consequences from a large~     group of students early in the seventh-grade year. Current usage will also be examined;~     extant data suggest that most students will be non-users at that time. It is known that a~     fair amount of initiation takes place during the seventh and eighth grade years. The~     hypothesis is that those non-users whose model scores are high will be more likely to~     initiate usage than those whose scores are low. The same students will be queried regarding~     usage eighteen months later to evaluate the hypothesis.~      It is now well known that differential knowledge regarding the harmful effects of drug use~     does not distinguish adolescent users from non-users. The model approach quantifies the idea~     that anticipated positive consequences play a prominent role in the decision of those who~     choose to initiate. An important implication is that prevention campaigns might profit by~     addressing positive as well as negative consequences of usage.~   "
250610|NCT00271830|"~     Sexual dysfunction is common in male patients with chronic renal failure on dialysis and~     after renal trasnplantation. Multiple factors play a role in this important clinical problem.~     Recent studies suggest that certain immunosuppressive medication used for solid organ~     transplant may affect male sexual function. The purpose of this study is to compare the~     sexual function of male renal transplant patients on sirolimus and those patients not on~     sirolimus immunosuppression.~   "
250611|NCT00271817|"~     To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high~     cholesterol.~   "
250612|NCT00271804|"~     The purpose of this study is to find out what the maximal tolerated dose of Velcade can be~     given with thalidomide in patients with myelodysplasia.~   "
250613|NCT00271791|"~     The purpose of the study is to investigate the value of steroids in the treatment of~     vestibular neuronitis. The potential benefits of steroid therapy would be analyzed by the~     clinical response, self-perceived handicap and laboratory parameters.~   "
250614|NCT00271778|"~     Mastoidotympanoplasty is a recognised surgery that is performed for chronic otitis media. But~     whether mastoidectomy in addition to tympanoplasty is really necessary in each and every case~     of quiescent chronic otitis media still remains controversial. Hence this study has been~     undertaken to study the differences in the outcomes of the 2 surgical procedures performed~     for chronic otitis media in a randomized control design.~   "
250615|NCT00271765|"~     The primary purpose of this study is to assess the safety of INO-1001 in subjects who have~     experienced a heart attack and are to be treated with coronary angioplasty.~   "
250616|NCT00271752|"~     This is a randomised, single blinded, multicentre trial to evaluate whether daily~     procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to~     abnormal values and day-to-day changes can reduce the mortality of critically ill patients in~     the Intensive Care Unit (ICU).~   "
250617|NCT00271739|"~     The IDEATel study is a multicenter randomized controlled trial to evaluate the efficacy,~     acceptability, and cost-effectiveness of telemedicine case management to provide diabetes~     care to elderly Medicare beneficiaries residing in medically underserved areas of New York~     State.~   "
250618|NCT00271726|"~     This is a prospective, randomized, multi-center pilot study of unstable extraarticular~     fractures of the distal radius with dorsal displacement of the distal fragment in elderly~     patients. The patients are randomly assigned to osteosynthesis with palmar locking plate,~     external fixator, or Kirschner wires.~      The aim of this pilot study is to allow a sample size calculation for a main randomized~     controlled trial (RCT). The primary outcome criterion is the functional status measured by~     the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria~     are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a~     pilot study it is intended to generate a study hypothesis for the main RCT.~   "
250619|NCT00271713|"~     Efficacy:~      To investigate changes of structural bone properties in vivo using 3DpQCT (Xtreme CT,~     Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis.~      Major structural bone parameters which determine bone strength and predict fracture risk~     earlier and more precisely are measurable in vivo by 3DpQCT.~      Safety:~      To assess the tolerability and safety of ibandronate therapy~   "
250620|NCT00271700|"~     This study will examine whether new processes and technologies for monitoring diabetic~     patients' insulin levels improves patient care at Brigham and Women's Hospital.~   "
250621|NCT00271687|"~     This study aims to provide preliminary data on the feasibility and outcomes of a 12 week~     exercise program on the quality of life of men with hormone refractory prostate cancer~     receiving docetaxel-based chemotherapy.~   "
250622|NCT00271674|"~     The purpose of the study is to compare patient satisfaction, clinical efficacy and adverse~     effects of Q-switched YAG laser versus punch biopsies for the treatment of tattoo dots that~     are applied as skin markers in relation to X-ray treatment of malignant disorders.~   "
250623|NCT00271661|"~     Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition~     known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a~     process called accommodation. It is caused by an increase in the stiffness of the lens of the~     eye that occurs naturally with aging. Currently, there are no known treatments that can be~     used to prevent or delay presbyopia. As a result, the risk, in later life, of having this~     condition is essentially 100%.~      The purpose of this research is to determine whether chemotherapy drugs are delaying the age~     at which people develop symptoms of presbyopia. We hope to establish that presbyopia can in~     fact be delayed with the use of drugs, which would ultimately lead to further research in~     this area.~   "
250624|NCT00271635|"~     Charcot-Marie-Tooth type IA (CMT1A) is the most prevalent hereditary peripheral neuropathy.~     Demyelination of peripheral nerves is the hallmark of CMT1A. Ascorbic acid has been shown to~     have a favorable influence on myelination in in vitro studies and in a mouse model for CMT1A.~     We will study the efficacy and safety of ascorbic acid treatment in young patients with~     CMT1A.~   "
250625|NCT00271622|"~     This study will screen children and adolescents (and their parents) to determine the child's~     eligibility for participation in NIMH research studies on autism spectrum disorders, such as~     autism and Rett's Disorder.~      Screening evaluations include some or all of the following procedures:~      Parent interview~      Parent and child evaluations including:~        -  Diagnostic interview~        -  Developmental or cognitive testing~        -  Ratings of psychiatric and medical symptoms~        -  Neuropsychological testing~        -  Personal, social an family history~      Child physical examination and possible blood draw~      Children who are determined eligible for a current NIMH research protocol are invited to~     participate.~   "
250626|NCT00271609|"~     Background:~      Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels~     in tumors. Inhibiting the formation of these blood vessels may slow or stop disease~     progression by diminishing the supply of life-sustaining nutrients and oxygen the blood~     delivers to the tumor.~      Bevacizumab is approved for treating colorectal cancer and has shown activity against brain~     tumor cells in laboratory and animal tests.~      Objectives:~      To examine the safety and side effects of bevacizumab in patients with recurrent brain~     tumors.~      To determine the anti-tumor activity of bevacizumab in patients with recurrent brain tumors.~      Eligibility:~      Patients 18 years of age and older with a brain tumor that continues to grow after receiving~     standard treatments.~      Design:~      Patients complete the following procedures during the study:~        -  Infusions of bevacizumab through a vein once every 2 weeks in 4-week treatment cycles.~        -  Positron emission tomography (PET) scan before the first dose of bevacizumab, at the end~          of the first treatment cycle, and as needed after that.~        -  Magnetic resonance imaging (MRI) scan before the first dose of bevacizumab, within 48-96~          hours after the first dose of bevacizumab in the first treatment cycle, and then every 4~          weeks. One tube of blood for research is collected at the time of each MRI scan to look~          at specific cells.~        -  Physical and neurological examinations every 2 weeks for the first treatment cycle and~          then every 4 weeks.~        -  Quality-of-life questionnaires every 4 weeks.~   "
250627|NCT00271596|"~     This research plan proposes to conduct a double-blind, placebo-controlled pilot clinical~     trial in 36 adults with mild Huntington's disease (HD) to address the following research~     aims:~        1. To determine the effect of citalopram compared to placebo in patients with early HD on~          executive function and other outcome variables including functional measures~          (health-related quality of life, work productivity, and self-reported attention), motor~          performance, and psychiatric status,~        2. To study the relationship between executive function and functional status in patients~          with early HD after selective serotonin reuptake inhibitor (SSRI) treatment, and~        3. To examine the effect of citalopram treatment on volumetric and metabolic (i.e,~          N-acetyl-aspartate concentration) measures in the neostriatum among patients with~          recently diagnosed Huntington's disease.~   "
250628|NCT00271583|"~     Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new~     antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception~      Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of~     CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception~      Subjects are randomized to receive a one-time treatment with either one dose of 50 mg~     CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with~     follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days~     after expected onset of menses (if needed)~      The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency~     postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.~   "
250629|NCT00271570|"~     This study evaluates the safety of infliximab in infants and children with acute Kawasaki~     Disease.~   "
250630|NCT00271557|"~     The purpose of this safety study is to evaluate NATRECORÂ® hBNP (a recombinant form of the~     natural human peptide normally secreted by the heart in response to heart failure), in~     subjects with worsening congestive heart failure for whom inpatient intravenous therapy with~     medications that influence the tone and caliber of blood vessels is deemed appropriate.~   "
250631|NCT00271544|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. When there are~     changes in the heart beat sometimes an implantable heart device is used to control the rate~     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of~     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may~     be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the~     upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles~     through three or four leads (flexible insulated wires) that are inserted through the veins to~     the heart. The purpose of this study is to evaluate a new lead for delivering energy to the~     left ventricle (bottom left chamber of the heart).~   "
250632|NCT00271531|"~     The purpose of this study is to develop a scoring system to allow doctors to accurately~     identify children on a mechanical ventilator who have bacterial pneumonia. Currently this~     diagnosis is very difficult to make, resulting in the overuse of antibiotics and the~     promotion of antibiotic-resistant bacteria in the pediatric intensive care unit (ICU). Four~     ICUs at 3 children's hospitals will participate. Study participants will include 150~     children, ages 2 months to 17 years old who require mechanical ventilation, and in whom the~     bedside health care providers suspect bacterial pneumonia. Bacteria will be studied by~     sampling lung fluid through the breathing tube less than 12 hours after starting antibiotics,~     using a procedure known as non-bronchoscopic-bronchoalveolar lavage (NB-BAL). Participants~     may be involved in study related procedures for up to 31 days.~   "
250633|NCT00271518|"~     The purpose of this study is to compare a new weekly administered growth hormone preparation~     with standard daily treatment in children with insufficient secretion of growth hormone~   "
250634|NCT00271505|"~     The goal of this clinical research study is to evaluate the effectiveness of Avastin® in~     combination with docetaxel and carboplatin in the treatment of lung cancer. The safety of~     this combination will also be studied.~   "
250635|NCT00271492|"~     Qualifying patients who are scheduled for angiogram with endothelial function testing are~     approached to participate in this protocol (consent form reviewed with patient). Those who~     are willing to participate will have additional measurements taken during their angiogram as~     part of this protocol. Patients who are diagnosed with Endothelial Dysfunction as a result of~     a clinically indicated angiogram will be eligible to participate in a 6 month medication~     trial (Atrasentan vs. placebo - randomized, blinded trial). Patients are monitored closely~     during the 6 month trial via phone calls and blood testing for assessment. At the end of the~     6 months they return to Mayo for a repeat angiogram to assess endothelial function for any~     changes or improvements.~   "
250636|NCT00271479|"~     Hypothesis:~      Lower doses of each A/C/Y/W135 component of the meningococcal polysaccharide vaccine could~     confer a similar functional immunogenic response as the dose of 50 μg currently being used,~     and subsequently be equally protective.~      The purpose of this study is to evaluate the use of fractional dose tetravalent meningococcal~     polysaccharide vaccine to control outbreak especially caused by N. meningitidis serogroup~     W135~      Primary Objectives:~        -  To measure the immunogenicity of a dose corresponding to one fifth of the amount of the~          licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 10 μg for each component;~          and~        -  To measure the immunogenicity of a dose corresponding to one tenth of the licensed~          meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 5 μg for each component.~   "
250637|NCT00271466|"~     The objective of this study is to assess the safety of treatment with Duragesic® (a~     transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50,~     75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy.~     Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the~     subject's current narcotic pain relief therapy, and to the parameters for increasing the~     Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the~     bloodstream during treatment) will also be assessed.~   "
250638|NCT00271453|"~     The purpose of this study is to assess the effectiveness and safety of DurogesicÂ® (a~     transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of~     children with chronic pain requiring long-term narcotic pain relief therapy.~   "
250639|NCT00271440|"~     The purpose of this study is to compare the reductions in skin flora of newborns after a~     single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%)~     and to examine the safety of skin cleansing in neonates in Nepal.~   "
250640|NCT00271427|"~     Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb~     in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg.~     It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes~     against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX~     activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that~     If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be~     blocked by saturation of deficient stores of GPX solely and the mechanism of action requires~     more than repletion of deficient stores. It's important not only to estimate the optimal dose~     but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels~     in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment~     modality which can suppress the autoimmunity in more than 400 million AIT patients. Because~     there've been no way to suppress autoimmune war and replacement of LT4 had been the only~     treatment modality for palliation. An other independent part of the study is to test the~     effect of Se in adolescent AIT patients.~   "
250641|NCT00271414|"~     The objective of this study is to assess the safety and clinical utility of DuragesicÂ® 12.5~     micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the~     treatment of children ages 2 to 12 with continuous pain requiring narcotic pain relief~     therapy. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be~     assessed.~   "
250642|NCT00271401|"~     The purpose of this study is to compare the effectiveness and safety of intracoronary~     stenting with or without abciximab, an anti-platelet therapy, and conventional coronary~     angioplasty with abciximab in patients undergoing percutaneous coronary intervention.~   "
250683|NCT00270868|"~     The purpose of this study is to determine if the double guide wire technique is more~     effective than the conventional method in those cases of difficult selective biliary~     cannulation in the ERCP procedures.~   "
250643|NCT00271388|"~     The purpose of the current proposal is to pilot a new and potentially improved treatment for~     neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the~     vestibular nerves that lie directly below the mastoid bones.~   "
250644|NCT00271375|"~     This project implemented and evaluated the Rosalyn Carter Institute's (RCI's) educational and~     support program for caregivers, Caring for You, Caring for Me. Specifically, it examined~     effects of the program upon family caregivers to older adults in the Atlanta area and elderly~     Veterans receiving outpatient primary care at the Atlanta Veterans Affairs Medical Center~     (VAMC).~   "
250645|NCT00271362|"~     The purpose of the study is to compare the effect of different lower limb amputation surgical~     procedures on leg bone integrity and rehabilitation outcome.~   "
250646|NCT00271349|"~     Eosinophilic Esophagitis (EE) is a chronic, T-helper 2 cell (TH2) - type inflammatory~     disorder of the esophagus with a rapidly increasing prevalence. Studies analyzing the natural~     course of EE provide strong evidence, that the chronic inflammation leads to irreversible~     structural changes in the esophagus with a loss of the mucosal elasticity and a fibrosis of~     the sub-epithelial esophageal layers with a concomitant risk of impairment in function.~      Treatment strategies in chronic inflammations have, in general, two main goals: 1) Relief of~     symptoms and 2) Prevention of long-term damage of the affected organ. Until now, the~     treatment of EE is still controversial. Standard recommendations for therapy of this chronic~     eosinophilic inflammation include dilation, systemic or topical corticosteroids and~     leukotriene antagonists. Several of these reports demonstrate, that topical corticosteroids~     may be effective for symptom control as well as for down-regulating the local inflammation.~     Furthermore it has been demonstrated, that treatment with topical corticosteroids is as~     effective as oral prednisone. However, the majority of therapeutic recommendations are based~     on clinical observations, case reports or small case series.~      The purpose of this study is the evaluation of the efficacy and the safety of a monotherapy~     with a topical corticosteroid as short-term induction-treatment and as long-term,~     maintenance-treatment compared with placebo, in the treatment of adult patients with active~     EE.~   "
250647|NCT00271336|"~     Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with~     sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature~     neonates.~   "
250648|NCT00271323|"~     -  Primary : To determine the safety profile of each treatment group.~        -  Secondary : To determine efficacy in term of overall response, disease free survival and~          survival at 1 and 2 years.~   "
250649|NCT00271310|"~     The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on~     lung function, incidence of respiratory tract infections, quality of life, quantitative~     microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of~     nebulised hypertonic saline will have a beneficial effect on lung function and other clinical~     outcomes with no adverse effects on infection and inflammation in adults and children with~     cystic fibrosis.~   "
250650|NCT00271297|"~     Background:~      The pelvic floor muscles (PFM) are located inside the pelvis, surrounding the urethra, vagina~     and rectum. They provide structural support for the pelvic organs. Dysfunctional PFM can lead~     to urine and fecal incontinence, pelvic organ prolapse (POP), sexual problems and chronic~     pain syndromes. POP increases with age, parity and weakness in the PFM. Symptoms associated~     with POP are backache, bladder, bowel and sexual dysfunction, and pelvic heaviness. Thus the~     condition is debilitating and can greatly affect the quality of life, interfering with~     day-to-day activities and reduce participation in physical activity.~      The aim of the project:~      As life expectancy increases, more women may experience POP. Hence it is important to prevent~     and treat the condition at an early stage. Despite being a common disorder among women,~     little research has been done on POP. The aim of this study is to evaluate the effect of~     pelvic floor muscle training (PFMT). PFMT is a non-invasive method with no adverse effects.~     If there is significant effect, the main goal is to incorporate this method in clinical~     practice among physiotherapists and medical doctors. If PFM training is effective, more~     emphasis of PFM training can be put into regular female fitness programs. The prevalence of~     POP increases with age.~      Method:~      This is a single blind randomised controlled trial to evaluate the effect of PFMT on POP. 100~     women with POP will be randomised to either training or control group. The training programme~     will last for six months, training once a week with a physiotherapist in addition to a~     structured home training programme. A blinded case-control study will also be carried out. 50~     women without POP will be matched for age and vaginal deliveries. Before starting the RCT~     study, a reproducibility study on perineal ultrasound will be carried out in 18 women.~   "
250651|NCT00271284|"~     ·Main objective: To compare the variability of fasting capillary blood glucose concentration,~     observed with insulin glargine combined with insulin glulisine and with insulin detemir~     combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.~      ·Secondary objectives:~      Efficacy:~        -  To compare the variability of blood glucose concentration before the evening meal,~          observed with insulin glargine combined with insulin glulisine and with insulin detemir~          combined with insulin glulisine, in type 1 diabetics.~        -  To record the intra- and inter-daily variability using the MAGE and MODD indices~          [1,2,3,4]~        -  To compare the glycaemic profiles (7 points)~        -  To evaluate the HbA1c concentration, at the end of each period of treatment, weight~          change, the dose of insulin used and the number of daily injections.~      Tolerance:~        -  To record undesirable events~        -  To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic,~          diurnal, nocturnal, severe).~   "
250652|NCT00271271|"~     Primary:~      ·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as~     first line treatment in patients with non-small cell bronchopulmonary cancer~      Secondary:~      ·To evaluate the toxicity of the combination~   "
250653|NCT00271258|"~     - Main objective: To evaluate the clinical and physiological tolerance of sodium divalproate~     in manic, mixed or hypomanic episodes of bipolar disorder in adolescents treated for 6~     months.~      - Secondary objective: To evaluate the efficacy of sodium divalproate in improving manic,~     mixed or hypomanic symptoms.~   "
250654|NCT00271245|"~     The purpose of this study is to determine whether patients with liver cirrhosis can improve~     their selenium nutritional status by taking supplemental selenium.~   "
250684|NCT00270855|"~     The purpose of this proposal was to evaluate and compare the health benefits of using upper~     extremity exercise versus functional electrical stimulation for lower extremity exercise. It~     was our hypothesis that both Functional Electrical Stimulation Leg Cycle Ergometry (FES LCE)~     exercise and voluntary Arm Crank Ergometry (ACE) upper extremity exercise would increase~     whole body energy expenditure, thereby increasing muscle mass, insulin sensitivity, glucose~     effectiveness and improving lipid profiles in adults with paraplegia.~   "
250655|NCT00271232|"~     People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,~     may be in need of an electronic device called an implantable cardioverter defibrillator~     (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it~     sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If~     the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to~     return the heart to its normal rhythm.~      The InSync III Marquis device can change the timing of when the left and right ventricles of~     the heart are paced to beat. This is called V to V timing. V to V timing may further~     improve the pumping function of the heart. The purpose of this study is to determine whether~     or not this V to V timing feature of the InSync III Marquis system is safe and effective.~   "
250656|NCT00271219|"~     Children born to women who abuse drugs have a high risk of being born with birth defects and~     developmental problems. Methadone is a drug that is commonly used for treating opioid~     dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a~     newborn because of the prenatal exposure. The purpose of this study is to evaluate the~     effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal~     symptoms in children born to opioid-dependent women.~   "
250657|NCT00271206|"~     Past research on nicotine addiction has shown that changes in estradiol and progesterone~     hormone levels during menstruation may cause women to respond differently than men to~     nicotine. The purpose of this study is to examine the effects of progesterone on smoking~     behavior, nicotine withdrawal symptoms, and the reinforcing effects of smoking in men and~     women addicted to nicotine.~   "
250658|NCT00271193|"~     The study will test whether adding brief counseling visits with an ancillary health care~     provider (a nurse or nursing assistant) will induce additional weight loss, as compared with~     quarterly physician visits alone. All visits will take place at the site of usual patient~     care (i.e., the primary care clinic).~   "
250659|NCT00271180|"~     The main purpose of the Product Performance Report (formerly referred to as System Longevity~     Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm~     products by analyzing product survival probabilities.~   "
250660|NCT00271167|"~     The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP~     ribose] polymerase) inhibitor, in patients undergoing heart surgery. The study also measures~     whether INO-1001 reduces the side effects caused by heart-lung bypass machines.~   "
250661|NCT00271154|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. When there are~     changes in the heart beat sometimes an implantable heart device is used to control the rate~     and rhythm of the heart beat. The purpose of the REVERSE clinical trial is to determine~     whether pacing in both the left and right ventricles using Cardiac Resynchronization Therapy~     (CRT) can help slow the progression of heart failure in people who have mild or previous~     symptoms and poor heart pumping function. This kind of therapy has previously been shown to~     reduce symptoms and improve exercise capacity in people with more advanced forms of heart~     failure.~   "
250662|NCT00271141|"~     The proposed work is based on the detection of a novel molecule for sensitivity to oxidative~     stress in humans in venous blood~   "
250663|NCT00271128|"~     The proposed study intends to evaluate the impact of the NT-proBNP assay on the diagnosis of~     heart failure in patients with dyspnea of unknown etiology presenting to the emergency room~     and admitted to the medical wards.~   "
250664|NCT00271115|"~     The primary objective is to determine if kangaroo holding in the first week after birth~     influences the stress levels of mothers who have delivered their infants prematurely and who~     require admission to the Special Care Nursery (SCN).~      Hypothesis: There will be a decrease in maternal stress levels as perceived by mothers and as~     reflected in their blood pressures and heart rates after kangaroo holding their premature~     infants in the SCN.~   "
250665|NCT00271102|"~     The purpose of this study is to determine whether vaginal repair or abdominal repair is the~     procedure of choice for the surgical management of a prolapsed bladder.~   "
250666|NCT00271089|"~     Fanconi anemia (FA) is a disease that affects an individual's bone marrow. It is caused by a~     defective gene in the CD34+ cells, which are responsible for producing various types of blood~     cells. Individuals with FA may experience fatigue, bleeding, and increased infections. The~     purpose of this study is to collect and purify blood cells from individuals with FA and store~     them for future therapeutic use.~   "
250667|NCT00271076|"~     To assess the safety and feasibility of Volcano Corp Eagle Eye Gold Catheter system to~     correlate the presence and characteristic of carotid artery atherosclerotic disease with~     anatomic and histologic analysis.~   "
250668|NCT00271063|"~     This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum~     tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin~     in patients with refractory or relapsed acute lymphocytic leukemia.~   "
250669|NCT00271050|"~     The purpose of the research study is to learn whether external beam radiation can be used as~     a safe and effective treatment for patients with bulky (≥ 5cm) sites of non-Hodgkin's~     lymphoma prior to treatment with 90Y-ibritumomab tiuxetan (Zevalin).~   "
250670|NCT00271037|"~     Pelvic organ prolapse occurs when the pelvic organs (e.g., the uterus or bladder) fall or~     slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. Some types~     of surgery try to restore the normal anatomy and function of the vagina (i.e., reconstructive~     surgery). Other surgery repairs the prolapse by essentially closing the vagina (e.g.,~     colpocleisis or colpectomy), thereby leaving a woman unable to have vaginal intercourse in~     the future. The use of colpocleisis has not been well-studied. The current literature is~     lacking sufficient studies of colpocleisis to fully understand its risks and benefits for~     women considering surgery for prolapse. Traditionally, colpocleisis has been restricted to~     elderly women thought to be poor medical risks for prolonged reconstructive surgery. This~     study will describe the postoperative course of women who undergo colpocleisis, with~     particular attention to the persistence or recurrence of urinary incontinence and patient~     satisfaction after the colpocleisis prolapse surgery.~   "
250685|NCT00270842|"~     The purpose of this study is to find out if participation in one of the study groups:~     functional balance training, Tai Chi, or education, results in better outcomes overall. The~     outcomes that we are primarily interested in are related to walking ability and balance.~   "
250671|NCT00271024|"~     The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to~     compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard~     smoking cessation treatment with nicotine patch and counseling.~      Hypotheses:~        1. Naltrexone will improve smoking cessation quit rates, as measured at the end of active~          treatment (3 months) and during long term follow up (1 year).~        2. Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving~          and withdrawal) will be important factors by which naltrexone improves smoking cessation~          outcome.~        3. These effects are predicted to be stronger in women compared to men.~   "
250672|NCT00271011|"~     Colorectal cancer (CRC) is one of the more common cancers in the United States with over~     145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some~     who relapse after surgery, or are unable to have surgery, chemotherapy is the primary~     treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by~     themselves, but many are given in combination with other chemotherapy treatment drugs and~     they seem to work better together than by themselves. This study will investigate the~     effectiveness of the combination of three chemotherapy drugs in patients who have been~     previously treated for their CRC and it has returned. This study will also evaluate any rash~     that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C,~     Irinotecan, and Cetuximab.~   "
250673|NCT00270998|"~     Stress urinary incontinence is the uncontrollable leakage of urine with physical effort or~     stress, such as coughing, sneezing, or exercise. Treatment for stress incontinence can be~     surgical or non-surgical. Different non-surgical treatments include pelvic muscle exercises~     and pessary use. Pelvic muscle exercises (often known as Kegel exercises) train and~     strengthen the pelvic muscles and improve incontinence. A pessary is a medical device that~     fits inside the vagina to give the urethra and bladder extra support and prevent or reduce~     urinary incontinence. Exercises and pessary use can help women with stress incontinence but~     it is not known which treatment is better, or if a combination of the two treatments at the~     same time is best. This study will determine whether pelvic muscle training and exercises,~     pessary use, or a combination of both exercises and pessary is most effective at improving~     incontinence in women. The study's primary hypothesis is that pessary use is more effective~     than pelvic muscle exercises after 3 months of treatment.~   "
250674|NCT00270985|"~     Study Hypothesis:~      Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c)~     levels in adults with pre-diabetes.~      Lay Summary:~      Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition~     called pre-diabetes. Lifestyle is a major factor that determines whether pre-diabetes becomes~     full T2DM. Lifestyle includes dietary habits and physical activity. Many people develop T2DM~     because of poor dietary habits and a sedentary lifestyle. Moreover, eating a high-fat,~     high-sugar diet can damage the blood vessels and increase the risk of strokes and heart~     attacks. A person's diet may produce substances in the blood that can interfere with the~     production of insulin in the pancreas. Sometimes, these changes in the insulin producing~     cells are serious and can eventually interfere with how the cells in the body use blood~     sugar, which causes T2DM. Techniques are available to measure circulating substances in the~     blood of persons with pre-diabetes that may be associated with the development of T2DM.~     Laboratory research has shown that almonds contain high levels of important compounds that~     may influence the onset of heart disease and T2DM. A meal plan that includes almonds daily~     will be given to half of the study participants and the other participants will be given a~     meal plan that is nut-free. Because of the potential to delay the onset of heart disease~     and T2DM in some persons with pre-diabetes, this 16-week study will collect and analyze blood~     samples for changes that may make the person with pre-diabetes more likely to develop heart~     disease and T2DM. Blood samples will be collected at weeks 0, 8 and 16 to measure compounds~     that may be influenced by consuming almonds daily. This study will also attempt to understand~     other possible causes of heart disease and T2DM in persons with pre-diabetes; particularly~     those that might be related to body weight and body composition. Body composition techniques~     using very small amounts of electrical current are available to study body fat. Body weight,~     waist and hip measurements, blood pressure and body composition testing will be performed at~     the start of the study and every 4 weeks during the study. Lastly, these other possible~     causes of heart disease and T2DM will be investigated to look at relationships with the~     substances in the blood.~   "
250675|NCT00270972|"~     This study was designed to confirm the clinical benefits and safety of OrCel in the treatment~     of venous ulcers. OrCel and standard care are compared to standard care alone. Standard care~     consists of currently accepted compression therapy.~      Patients are treated for 12 weeks. Patients with healed ulcers are followed for an additional~     12 weeks to assess durability of the healed wound.~   "
250676|NCT00270959|"~     This study will evaluate the effectiveness of patient-centered collaborative care that~     combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms~     of post-traumatic stress disorder in people who have survived a traumatic injury.~   "
250677|NCT00270946|"~     This study was designed to evaluate the clinical benefits and safety of OrCel in the~     treatment of venous ulcers. OrCel and standard care were compared to standard care alone.~     Standard care consisted of currently accepted compression therapy.~      Patients were treated for 12 weeks. Patients with healed ulcers were followed for an~     additional 12 weeks to assess durability of the healed wound.~   "
250678|NCT00270933|"~     The purpose of this registry is to collect information on the health status of patients~     receiving Marquis/Maximo VR Implantable Cardiac Defibrillators (ICDs), how the devices are~     being programmed and how this correlates to clinical patient outcome.~   "
250679|NCT00270920|"~     This is a randomised controlled trial to compare antenatal preparation and postnatal~     counseling strategies for improving breastfeeding rates.~      The objectives are:~        1. to study the effect of a standard two-encounter postnatal lactation counseling protocol~          on the initiation and maintenance of exclusive breastfeediing in mothers~        2. to compare the effect of a standard two-encounter postnatal lactation counseling~          protocol with a single-encounter antenatal breastfeeding education protocol on the~          initiation and maintenance of exclusive breastfeeding in mothers.~   "
250680|NCT00270907|"~     The goal of this phase I clinical study is to find the highest safe dose of gemcitabine and~     CT-2103 that can be given in combination for the treatment of metastatic breast cancer. The~     safety and effectiveness of this combination will also be studied. This clinical trial will~     be offered to patients who are being considered for treatment with gemcitabine. Research lab~     samples and research biopsies will not be requested as part of this study.~   "
250681|NCT00270894|"~     The purpose of this study is to evaluate the effectiveness and tolerability of the~     combination of the following medications given every two weeks in HER2 positive breast cancer~     patients:~        -  trastuzumab (Herceptin)~        -  epirubicin (Ellence)~        -  cyclophosphamide (Cytoxan)~        -  docetaxel (Taxotere)~   "
250682|NCT00270881|"~     The primary purpose of this study is to evaluate the safety and efficacy of cord blood~     transplantation for adult patients with hematologic malignancies including refractory acute~     leukemia. The transplant procedure was determined in detail according to the previously~     published report showing a high survival, so that the investigators could expect a similar~     result.~   "
250686|NCT00270829|"~     The impact of nesiritide in CHF is unclear, but it is possible that systemic vasodilation~     leads to adverse consequences even if the direct renal effects are positive. Therefore, this~     study will look at the effects of direct intrarenal administration of nesiritide on GFR and~     RPF.~   "
250687|NCT00270816|"~     The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis~     with positive effects on the disease course. The 8 MUI dose at alternate days is kept~     constant for years. About 1/3 of patients suspend treatment by three years due to side~     effects or suspected or accepted ineffectiveness. The main objective of the study is to~     verify the safety and effectiveness of a cyclical administration (a month of suspension after~     two of treatment) from the beginning of treatment. There is the possibility that a scheme~     envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising~     the drug therapeutic effect) compared to the standard administration protocol. This might~     also result in an increase of the drug effectiveness and/or in a longer duration of~     effectiveness itself. Finally, cyclical administration allows patients to spend actual~     periods of therapeutic vacation, with positive psychological effects.~   "
250688|NCT00270803|"~     This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor~     coordination and brain metabolic activity in regular users of marijuana. Subjects were tested~     twice, after smoking cigarettes with marijuana and after smoking cigarettes without~     marijuana.On both occasions they performed on a virtual reality maze task. They were~     afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG).~   "
250689|NCT00270790|"~     Purpose of this study:~      There is some evidence that the best treatment for head and neck cancer involves a~     combination of radiation therapy and chemotherapy. Radiation therapy is a form of cancer~     treatment using high energy x-rays. Chemotherapy is a form of cancer treatment that uses~     special medications. This study uses two chemotherapy drugs (Taxol and Carboplatin), which~     are FDA approved for treating head and neck cancers. This treatment combination has been~     associated with difficulty, pain, or a burning sensation upon swallowing (called~     esophagitis), and decrease in blood cells (cells in the blood which fight against infection).~     The purpose of this study is to investigate whether the addition of another drug, Amifostine,~     can reduce the side effects of current combination treatment (radiation and chemotherapy~     which is standard of care). The addition of Amifostine is the investigational part of the~     study. The research study is also looking at the side effects of Amifostine and cancer's~     growth response to this combination treatment.~   "
250690|NCT00270777|"~     A study to increase the safety of polyvalent antivenom involving 1000 patients in three~     centres: low dose adrenaline, promethazine, & hydrocortisone (alone and in combination) to~     prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double~     blind, placebo-controlled trial.~   "
250691|NCT00270764|"~     The purpose of this study is to determine the social and economic outcomes of anti-HIV~     treatment in South African adults, with data collected from interviews, detailed~     questionnaires, and patients' medical records.~   "
250692|NCT00270751|"~     Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate,~     especially regarding the method of pleurodesis. Previous studies have shown that~     thoracoscopic apical pleurectomy is a reliable method with a very low incidence of~     recurrence. However, this procedure is more technical demanding and time consuming through~     thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary~     function and a higher risk of perioperative complication such as hemothorax. In our previous~     studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is~     an easy and convinent method of pleurodesis which decreases the rate of recurrence without~     affecting pulmonary function. In this study, we hypothesized that pleural abrasion with~     minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax~     recurrence while the short-term and long-term complications are less.~   "
250693|NCT00270738|"~     Urinary incontinence (UI) is the complaint of any involuntary leakage of urine. Stress~     urinary incontinence (SUI) is the complaint of involuntary leakage on effort or exertion, or~     on sneezing or coughing. The prevalence of female UI is greater than that of male, and the~     commonest type is SUI. UI has significant impact on the quality of life including physical,~     mental and social issues. SUI may also lead to withdraw from regular physical exercise and~     fitness activities that important in the prevention of osteoporosis, coronary heart disease,~     and so on. The cause of SUI is related to the impairment of pelvic floor muscles (PFM). So~     far, the effects of intensive pelvic floor muscle training for female SUI were proved in many~     randomized controlled trials. However, training of accurate contraction of PFM depends on~     vaginal palpation. The willingness to seek for medical help may be reduced due to being~     embarrassed with vaginal palpation. Sapsford proposed a concept to treat SUI via transversus~     abdominis (TrA) that does not need to palpate the vagina. Maybe the new intervention can~     promote the willingness to seek medical help. However, to date there is no randomized~     controlled trial comparing the effect of indirect training of the PFM via TrA with either~     untreated control or other intervention. Therefore, there are two purposes in this study, to~     compare the effect of indirect training of PFM via TrA with control group and to compare the~     effect of indirect training of PFM via TrA with PFMT for female SUI.~   "
250694|NCT00270725|"~     The purpose of this study is to determine the impact of anti-HIV treatment on the work~     attendance of employed people in South Africa. The study will enroll participants from a~     large manufacturing and distribution firm in South Africa.~   "
250695|NCT00270712|"~     The causes of deterioration of transplanted kidney function are poorly understood. The~     purpose of this study is to determine the disease processes that cause transplanted kidney~     dysfunction and loss in patients who received a kidney either recently or over a year prior~     to entering this study. This study will also identify specific characteristics in kidney~     transplant recipients that predict whether a kidney transplant will be successful.~   "
250696|NCT00270699|"~     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and~     subtropical regions of the world. The purpose of this study is to test the safety of and~     immune response to a new dengue virus vaccine in healthy adults.~   "
250751|NCT00269971|"~     The purpose of this study is to determine an effective dose of epoetin alfa to be~     administered prior to surgery, to decrease the need for blood transfusions during hip~     replacement. Epoetin alfa is a genetically engineered protein that stimulates red blood cell~     production.~   "
250697|NCT00270686|"~     Background:~      - Heritable disorders of connective tissue are genetic conditions that can affect the skin~     and other parts of the body. They are related to mutations in genes that are responsible for~     building tissues. The symptoms differ among disorders. Researchers want to study which genes~     may be responsible for different disorders. They will be performing a long-term (up to 10~     years) study and a study that requires a single visit. These studies will look at how these~     disorders affect the body and what genes may cause these conditions.~      Objectives:~      - To perform one-time and long-term studies of people who have heritable disorders of~     connective tissue.~      Eligibility:~      - Individuals at least 2 years of age who have or may have a heritable disorder of connective~     tissue.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood samples.~        -  Participants will be on one of two parts of this study. The longitudinal arm will~          require long-term study over about 10 years. The mutational analysis arm will involve a~          single visit.~        -  Longitudinal arm participants must be at least 12 years of age. They will have study~          visits at regular intervals for up to 10 years. The tests given at these visits may~          include all or some of the following:~        -  Blood, saliva, urine, and skin samples~        -  Heart and lung function tests~        -  Magnetic resonance imaging scans of the neck, chest, spine, and abdomen~        -  Other imaging studies such as x-rays, bone density scans, and ultrasounds~        -  Questionnaires about sleep, pain, and quality of life~        -  Photographs of affected areas.~        -  Mutational analysis arm participants will have a single study visit. They will provide~          blood and saliva samples. They will provide tissue from a skin biopsy. They will also~          let the researchers take photos of any affected body parts. They will complete~          questionnaires about sleep, pain, and quality of life.~   "
250698|NCT00270673|"~     Blood lactate levels have long been related to tissue hypoxia, a severe condition in~     critically ill patients associated with the development of organ system failure and~     subsequent death. Increased blood lactate levels and failure to normalize blood lactate~     levels during treatment have been associated with increased morbidity and mortality. However,~     evidence of improved clinical outcome of lactate-directed therapy is limited and difference~     in the use of blood lactate monitoring in the intensive care unit exists between hospitals.~     This warrants a study on the efficacy of early blood lactate-directed therapy. In this study~     the efficacy of 8 hours of early lactate-directed therapy (therapy aimed at resolving tissue~     hypoxia that is guided by serial blood lactate levels) will be compared with 8 hours of~     control group therapy (without lactate measurement).~   "
250699|NCT00270660|"~     The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types~     of chronic otitis media that are prone for complications. In which type are the complications~     more common? Which type gives rise to more hearing loss? How does the disease process in the~     3 types evolve? should the 3 types of otitis media be managed differently?~   "
250700|NCT00270647|"~     The use of vitamin E, vitamin C, beta carotene, and/or multivitamins may keep cancer,~     cardiovascular disease, eye diseases, or cognitive decline from occurring. This randomized~     clinical trial studied vitamin E, vitamin C, beta carotene, and/or multivitamins to see how~     well they work compared with placebos in preventing cancer, cardiovascular disease, eye~     disease, and cognitive decline in male doctors aged 50 years and older.~   "
250701|NCT00270634|"~     This study will see if voclosporin is safe and effective in preventing kidney transplant~     rejection.~   "
250702|NCT00270621|"~     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the~     effectiveness of the Strongest Families distance intervention compared to usual or standard~     care that is typically provided to children with mild to moderate Enuresis diagnoses. This is~     a single-centre trial based at the IWK Health Centre. The primary outcome is change in~     diagnosis.~   "
250703|NCT00270608|"~     The purpose of this study is to evaluate the effect of vigorous physical activity versus~     extremely sedentary life style during young age on the bone mineral density and general~     health in later life.~   "
250704|NCT00270582|"~     Primary to evaluate the 1-year treatment failure rate of two sequential chemotherapy~     regimens:~        1. weekly docetaxel plus cisplatin followed by gemcitabine and~        2. gemcitabine plus cisplatin followed by weekly docetaxel. Study design:Prospective,~          multi-center, open-labelled, randomized phase II study.~   "
250705|NCT00270569|"~     The primary endpoint of this phase II trial is the objective response rate of the stage I~     (low-dose) regimen. The secondary endpoints include treatment-related toxicity, the change in~     quality of life, progression free survival and overall survival. Simon's optimal two-stage~     design will be used to determine the patient number.~   "
250706|NCT00270556|"~     This 48 week study is designed to compare the substitution of the thymidine analogues~     zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated~     with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb~     fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed~     tomography (CT) scans and improved cholesterol and tryglicerides.~   "
250707|NCT00270543|"~     The primary endpoint of this phase II trial is the objective tumor response rate. The~     secondary endpoints include treatment-related toxicity, the clinical benefit response defined~     by the change in performance status and body weight, the change in quality of life,~     progression free survival and overall survival. Simon's optimal two-stage design will be used~     to determine the patient number.~   "
250708|NCT00270530|"~     Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia~     and its serious impact on both maternal and infant survival. Intermittent presumptive~     treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing~     the risk of malaria in pregnancy. However, based on a study done in western Kenya,~     HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis~     rather than the standard 2-dose regimen given during the second and third trimesters, as HIV~     appears to reduce the effectiveness of the SP drug combination. The goal of this study was to~     evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP~     dosing schedule in HIV-positive women.~   "
250709|NCT00270517|"~     This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral~     antibiotic in the treatment of community acquired pneumonia~   "
250710|NCT00270504|"~     The purpose of this study is to evaluate if the placement of a temporary urethral stent for~     up to 12 months, following dilation or internal urethrotomy (cutting open), results in a~     higher rate of urethral patency during the first year of follow-up when compared to the~     control group that does not receive a stent.~   "
250711|NCT00270491|"~     Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with~     weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel -~     capecitabine, in patients with metastatic breast cancer.~   "
250748|NCT00270010|"~     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus~     placebo for the treatment of anemia in AIDS (Acquired Immunodeficiency Syndrome) patients~     with anemia that is a result of this disease and zidovudine (AZT) treatment. Epoetin alfa is~     a genetically engineered protein that stimulates red blood cell production.~   "
250712|NCT00270478|"~     This study will examine the use of hydroxyurea and erythropoietin for treating sickle cell~     disease in patients who also have kidney disease or pulmonary hypertension (high blood~     pressure in the lungs). Hydroxyurea increases production of fetal hemoglobin in the red blood~     cells of patients with sickle cell disease, reducing the amount of sickle cells that cause~     pain and other complications requiring hospitalizations. However, hydroxyurea treatment has~     limitations: patients with sickle cell disease who have developed kidney disease may not be~     able to get the full benefit of the medicine, and hydroxyurea alone may not be able to treat~     life-threatening complications such as pulmonary hypertension or stroke. This study will~     determine which of two dosing schedules of hydroxyurea and erythropoietin is more effective~     for treating patients with sickle cell disease who also have kidney disease or pulmonary~     hypertension, and will examine whether the two drugs can lower blood pressure in the lungs.~      Patients 18 years of age and older with sickle cell anemia and kidney disease or pulmonary~     hypertension, or both, may be eligible for this study. Candidates are screened with a medical~     history, physical examination, blood tests, a 6-minute walk test (test to see how far the~     subject can walk in 6 minutes), and echocardiogram (ultrasound of the heart to measure blood~     pressure in the lungs).~      Participants undergo the following tests and procedures:~      Stabilization Phase: Patients take 2 hydroxyurea tablets a day until their fetal hemoglobin~     levels stabilize, usually over 2 to 4 months. They have blood tests every 2 weeks to monitor~     hemoglobin and fetal hemoglobin levels. At some time during this period, they undergo a test~     to measure kidney function, in which they are injected with an iodine-containing dye and wear~     a small pump for 1 day that injects a small amount of dye under the skin over 24 hours. They~     come to the clinic for 2 or 3 blood tests collected over 4 hours.~      Sequence I (Standard): When the fetal hemoglobin levels have been stable for 2 months,~     patients have a repeat echocardiogram and 6-minute walk test. Erythropoietin is then added to~     the hydroxyurea regimen. It is given 3 days a week, as an injection under the skin, along~     with iron supplements. Patients have blood tests and blood pressure measurements every week~     or every other week. Patients with pulmonary hypertension have another echocardiogram and~     6-minute walk test once the hemoglobin level is stable.~      Sequence II (Cycled): When hemoglobin levels have stabilized with hydroxyurea once a day and~     erythropoietin 3 times a week, the hydroxyurea is adjusted so that the amount taken in 7 days~     is cycled over 4 days, and the erythropoietin is cycled over 3 days, with the dose~     increased twice, every 3 to 4 weeks. Blood pressure and hemoglobin are monitored once or~     twice a month. Patients with pulmonary hypertension have another echocardiogram and 6-minute~     walk test once the hemoglobin level is stable.~      Patients who develop complications while taking the drugs have their treatment regimens~     adjusted as needed.~   "
250713|NCT00270465|"~     Study Design: This is a Phase I, randomized, placebo-controlled, double-blinded study to~     examine safety, tolerability and immune response of a prime-boost vaccination regimen for~     treatment of HIV infection. The vaccination schedule consists of three injections of a~     multiclade HIV plasmid DNA vaccine followed by one injection of a multiclade recombinant~     adenoviral vector vaccine (rAd), in HIV-infected adults. The hypothesis is that this~     vaccination regimen will be safe and elicit an immune response in HIV-infected subjects. The~     primary objectives are related to evaluating the safety and tolerability of the vaccination~     regimen and assessing the effect of vaccination on humoral and cellular immune responses to~     vaccine-specific HIV antigens.~      Product Description: VRC-HIVDNA016-00-VP is composed of 6 closed, circular DNA plasmids that~     are each 16.67% (by weight) of the vaccine. Each of the 6 plasmids in this vaccine expresses~     a single gene product. Plasmids VRC 4401, VRC 4409 and VRC 4404 are designed to express clade~     B HIV-1 Gag, Pol and Nef, respectively. VRC 5736, VRC 5737, and VRC 5738 are designed to~     express HIV-1 Env glycoprotein from clade A, clade B, and clade C, respectively. Each DNA~     vaccination will be 1 mL of vaccine administered intramuscularly (IM) using the Biojector~     2000 Needle-Free Injection Management System. Phosphate buffered saline (PBS) will be used as~     the placebo for the DNA vaccine.~      VRC-HIVADV014-00-VP (rAd) is a recombinant product composed of 4 adenoviral vectors (Ad) (in~     a 3:1:1:1 ratio) that encode the HIV-1 Gag/Pol polyprotein from clade B and HIV-1 Env~     glycoproteins from clades A, B, and C, respectively. Injections of 10(10) PU will be~     administered IM by needle and syringe. The final formulation buffer (FFB) will be used as the~     placebo for the rAd vaccine.~      Subjects: HIV-infected adult volunteers (18-50 years old) on stable highly active~     antiretroviral therapy (HAART) therapy who have a CD4+ cell count greater than 350 cells/mm3~     and have had a viral load (VL) less than 400 copies/mL for at least six months and a viral~     load of less than 50 copies/mL within 4 weeks prior to enrollment.~      Study Plan: Fifteen volunteers will be enrolled and randomized in a 2:1 ratio to~     vaccine:control (10 DNA prime with rAd boost:5 PBS with FFB placebo). A Data and Safety~     Monitoring Board (DSMB) will review the study every 6 months. Subjects will be evaluated for~     safety and immunogenicity for 48 weeks, which is 24 weeks after the target date for the~     booster vaccination.~      Study Duration: Subjects will be followed for 48 weeks after enrollment into the study.~   "
250714|NCT00270452|"~     This study will test whether certain patients with myelodysplastic syndrome (MDS), acute~     myeloid leukemia (AML) or chronic myeloid leukemia (CML) can safely be vaccinated with two~     peptide vaccines derived from proteins called proteinase 3 (PR1) and Wilm's tumor-1 (WT1).~     These proteins are produced in large amounts by cells of MDS, AML and CML patients. The~     peptides are combined with an adjuvant called Montanide to make the vaccines, and the~     vaccines are given with GM-CSF (sargramostim). Both Montanide and sargramostim help the~     immune system respond to the vaccines. The vaccines then activate the immune system to make~     specialized cells that search out and kill the MDS, AML and CML cells containing the two~     proteins.~      Patients with MDS, AML or CML who are 18 years of age or older may be eligible for this~     study. Candidates are screened with a medical history and physical examination, blood tests,~     chest x-ray, and bone marrow aspirate and biopsy. For the bone marrow biopsy, the area of the~     hip is anesthetized and a special needle is used to draw marrow from the hipbone.~      Participants receive an injection (shot) of each peptide vaccine into deep tissue of the~     upper arm, upper leg, or the abdomen and two separate shots of sargramostim in the same area~     as the vaccine shots. Patients' vital signs (heart rate, breathing rate, temperature, blood~     pressure) are measured before and after they receive the vaccines and they are watched for 2~     hours after the shots for possible side effects, such as chills, pain at the injection site,~     stomach upset, allergic reaction, low blood counts, and infection.~      Patients return to the clinic 1, 2, 3 and 4 weeks after receiving the vaccines for a brief~     physical evaluation and blood tests. A chest x-ray is also done at the 4-week visit. Patients~     may receive whole blood or platelet transfusions if needed to treat the MDS, growth factors~     (filgrastim, erythropoietin, or others) if needed, and medications to treat any infections~     that may develop.~   "
250715|NCT00270439|"~     The purpose of this study is to determine whether laparoscopic removal of the omentum (thin~     layer of fat inside the abdomen) will significantly improve insulin resistance in patients~     with non-insulin dependent type 2 diabetes mellitus.~   "
250716|NCT00270426|"~     The purpose of this study is to further determine whether benazepril, could safely slow the~     progression of renal dysfunction in non-diabetic patients with advanced renal insufficiency.~   "
250717|NCT00270413|"~     This study tests the hypothesis that SU11248 can delay tumor progression after tumor mass~     reduction by taxanes. This is a dual-arm open-label randomized multicenter phase II clinical~     trial with 2:1 randomization evaluating the efficacy of SU11248 versus nil in patients with~     metastatic breast cancer after objective response to taxane chemotherapy. Patients randomized~     to the placebo arm (Arm B) will be offered the opportunity to receive open-label SU011248~     treatment upon development of Response Evaluation Criteria in Solid Tumors (RECIST)-defined~     disease progression.~   "
250718|NCT00270400|"~     The purpose of this study is to compare the effects on heart rate and ventricular arrhythmias~     (irregular heart beats) of two doses of NatrecorÂ® (a recombinant form of the natural human~     peptide normally secreted by the heart in response to heart failure) versus dobutamine,~     during the first 24 hours of treatment of decompensated congestive heart failure (CHF).~   "
250719|NCT00270387|"~     The purpose of this pilot study is to compare the clinical effects, safety profile, and~     economic impact of standard therapy plus NatrecorÂ® (nesiritide, a recombinant form of the~     natural human peptide normally secreted by the heart in response to heart failure) to~     standard therapy plus placebo in patients who present to the Emergency Department with~     worsening congestive heart failure (CHF) and are treated in the Emergency Department~     /Observation Unit.~   "
250720|NCT00270374|"~     The purpose of this study is to compare the hemodynamic (blood flow) and clinical effects of~     the study drug, Natrecor (nesiritide, a recombinant form of the natural human peptide~     normally secreted by the heart in response to heart failure) to those of intravenous~     nitroglycerin or placebo, when added to the standard care therapy that is usually~     administered in the treatment of patients with worsening congestive heart failure.~   "
250749|NCT00269997|"~     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus~     placebo in the treatment of persistent anemia caused by advanced cancer and aggressive~     cisplatin chemotherapy. Epoetin alfa is a genetically engineered protein that stimulates red~     blood cell production.~   "
250721|NCT00270361|"~     The purpose of this study is to assess the safety and tolerability of two doses of nesiritide~     (a recombinant form of the natural human peptide normally secreted by the heart in response~     to heart failure) when administered serially as a treatment to outpatients with worsening~     congestive heart failure (decompensated CHF) who are receiving their usual cardiac~     medications and are at high risk for hospitalization.~   "
250722|NCT00270348|"~     The primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered~     once daily in the morning is non-inferior to placebo with respect to growth velocity in~     children with mild persistent asthma following a 12-month treatment period~      The secondary objective is to investigate changes in growth in terms of bone age (wrist~     X-ray), and maintenance of asthma control and safety with ciclesonide~   "
250723|NCT00270335|"~     An accurate dosage of anesthetics during surgery is important. Usually this is achieved~     through close observation of the patient, but a new monitor (CSM-monitor) can measure the~     level of anesthesia more closely.~      In obese patients dosage of drugs is difficult due to the change in body composition. The~     CSM-monitor may provide a more accurate dosage of propofol (an anesthetic agent) during~     surgery, and as a consequence of that, also reduce the postoperative need for analgesics.~      Main objective: To optimise propofol dosing in obese patients undergoing hysterectomy.~      Main hypothesis: Monitoring the depth of anesthesia using the CSM-monitor reduces time to~     opening eyes in obese patients after hysterectomy in propofol anesthesia.~      Secondary hypotheses: CSM-monitoring reduce propofol dose in obese patients undergoing~     hysterectomy. Patients with a high CSM-level during hysterectomy have higher postoperative~     consumption of analgesics. Supplementary, an algorithm for the dose of propofol that most~     frequently results in a CSM-level between 40 and 60 is calculated.~   "
250724|NCT00270322|"~     The study purpose is to compare the effectiveness of different methods for post-operative~     pain treatment after total knee replacement.~   "
250725|NCT00270309|"~     Objective To test the hypothesis that a nurse-led self-management programme is effective for~     men with uncomplicated lower urinary tract symptoms. This will be achieved by comparing~     symptom seveirty and the amount of drug therapy used to manage these symptoms in men who~     attend a self-management programme, compared to those who do not.~      Study design This study will use the format of a randomised controlled trial. 200 new~     patients with uncomplicated LUTS will be randomised to either attend or not attend (standard~     therapy) a self-management programme. The programme provides education, reassurance, prostate~     cancer risk, advice on lifestyle modifications (e.g. fluids - type and amount), concurrent~     medication re-scheduling and behavioural changes (double-voiding, strategies for dribbling,~     and bladder re-training). These strategies are learnt through group discussion, problem~     solving and goal setting.~      All men start the study with a period of watchful waiting (monitoring symptoms only) and are~     followed up for a total of 1 year. At each assessment (baseline, 3, 6, and 12 months) symptom~     severity and the use of drug therapy to control symptoms will be compared between the two~     groups. The only difference between them is that one group has attended a self-management~     programme and the other has not.~      Potential application of results Self-management focuses on patient involvement in health~     care by involving them in the day-to-day control of their symptoms. If effective,~     self-management may provide a long-term method of managing LUTS without using drug therapy,~     thereby offering considerable health gain and financial savings.~      The NHS Modernisation Agency wishes to develop the role of the nurse specialist to manage~     some patients independently of doctors. Nurse-led LUTS assessment clinics are now well~     established, perhaps nurses managing these patients with self-management interventions may~     become part of standard therapy.~   "
250726|NCT00270296|"~     Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child~     transmission (MTCT) of HIV in developed countries. However, little is known of the~     effectiveness of such regimens in developing countries, such as Botswana. This study will~     determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and~     zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV)~     is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected~     pregnant women in Botswana.~   "
250727|NCT00270283|"~     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa in AIDS~     patients for the treatment of anemia that is a result of the disease and zidovudine (AZT)~     treatment. Epoetin alfa is a genetically engineered protein that stimulates red blood cell~     production.~   "
250728|NCT00270270|"~     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus~     placebo in AIDS patients for the treatment of anemia that is a result of the disease or a~     result of zidovudine (AZT) treatment for AIDS. Epoetin alfa is a genetically engineered~     protein that stimulates red blood cell production.~   "
250729|NCT00270257|"~     Drug abuse and HIV/AIDS are serious global health problems. Injection drug use is currently~     the major mode of transmission of HIV in many countries. The purpose of this study is to~     determine the effectiveness of drug and risk reduction counseling combined with either~     substitution drug treatment with buprenorphine/naloxone (BUP/NX) or short-term detoxification~     with BUP/NX in preventing HIV transmission among injection drug users. Participants will be~     recruited for this study in China and Thailand.~   "
250730|NCT00270244|"~     This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus~     treatment as usual (TAU) in improving the treatment of depressed adolescents in school-based~     health clinics.~   "
250731|NCT00270231|"~     Despite preclinical evidence supporting the role of the endogenous opioid system in the~     reinforcing effects of nicotine, the efficacy of the opioid antagonist naltrexone (NTX) as a~     tobacco dependence treatment remains unresolved. Research is needed to identify those smokers~     for whom NTX will have the strongest beneficial effects on smoking behavior.~      The research bridges existing knowledge of genetic, pharmacologic, and behavioral responses~     to nicotine, and translates this knowledge to treatment for tobacco dependence. The immediate~     goal was to test whether genetic variation in the mu-opioid receptor gene predicts the~     effects of naltrexone (NTX) on nicotine reinforcement.~   "
250732|NCT00270218|"~     The purpose of this study is to determine the safety of and immune response to an adenoviral~     vector HIV vaccine or a DNA HIV vaccine, each followed by an adenoviral vector HIV vaccine~     boost, in HIV uninfected adults.~   "
250733|NCT00270205|"~     LC002 is an experimental therapeutic vaccine designed to boost the immune response of people~     infected with HIV. The purpose of this study was to determine the safety and tolerability of~     and immune response to LC002 in HIV-1-infected adults who are currently receiving anti-HIV~     treatment.~   "
250750|NCT00269984|"~     The purpose of this study is to determine the safety and effectiveness of epoetin alfa versus~     placebo, injected beneath the skin, in the treatment of patients with persistent anemia~     caused by advanced cancer, with a below normal hematocrit of <= 37%. Epoetin alfa is a~     genetically engineered protein that stimulates red blood cell production.~   "
250734|NCT00270192|"~     This randomized controlled trial addresses the impact of simple antenatal breastfeeding~     educational interventions on breastfeeding rates and practice in a tertiary hospital setting.~      Hypothesis: A single antenatal encounter, which includes breastfeeding educational material~     and individual instruction with a lactation counselor, can improve the initiation, duration~     and exclusivity of breastfeeding compared to routine antenatal care or the use of educational~     material alone~   "
250735|NCT00270179|"~     The purpose of this study is to evaluate the whether epoetin alfa stimulates the bone marrow~     to produce red blood cells and therefore increases a patient's ability to self-donate blood~     prior to major surgery. Epoetin alfa is a genetically engineered protein that stimulates red~     blood cell production.~   "
250736|NCT00270166|"~     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus~     placebo in reducing or preventing the need for transfusions in anemic patients with cancer~     receiving chemotherapy, and to investigate possible quality-of-life benefits associated with~     the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red~     blood cell production.~   "
250737|NCT00270153|"~     Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss.~     Angiotensin-II may play a role in the development and progression of CAN. Angiotensin~     converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of~     angiotensin-II. However these drugs have been reported to cause elevated potassium and~     creatinine levels in some renal transplant patients. Yet, there are now several retrospective~     reports of long term benefits of improved renal function and graft survival in renal~     transplant recipients. There have been no reports of prospective randomized controlled trials~     of ACEI in renal transplant patients in the early post transplant period.~      The purpose of the present study is to assess the safety of enalapril, a drug in the ACEI~     class, when started 1-3 month post transplant. This is a double-blinded, randomized control~     trial of enalapril vs. placebo in new renal transplant patients with serum creatinine values~     no higher than 2.5mg/dl and normal serum potassium levels. The study drug will be~     administered for 6 months. Patients will be monitored in the renal transplant clinic every~     1-4 weeks according to routine protocol. Clinical end-points will be occurence of potassium~     >5.9mEQ/L or sustained increase in serum creatinine >50% from baseline.~   "
250738|NCT00270140|"~     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa at~     doses of 150, 300, or 600 units per kilogram of body weight versus placebo in facilitating~     presurgical collection of blood for self-donation during surgery of the knee, hip or spine.~     Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.~   "
250739|NCT00270127|"~     The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in~     reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer~     on non-platinum chemotherapy, and to investigate quality-of-life benefits associated with the~     use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red~     blood cell production.~   "
250740|NCT00270114|"~     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa and to~     determine whether epoetin alfa will facilitate self-donation of blood before surgery in~     patients who have anemia, (as indicated by low hematocrit levels, the percent of red blood~     cells in whole blood) and who will be undergoing orthopedic surgery. Epoetin alfa is a~     genetically engineered protein that stimulates red blood cell production.~   "
250741|NCT00270101|"~     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus~     placebo in reducing the transfusion requirements in anemic patients with multiple myeloma,~     and to investigate the quality-of-life benefits associated with the use of epoetin alfa.~     Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.~   "
250742|NCT00270088|"~     The purpose of this study is to evaluate the safety of epoetin alfa and to determine whether~     epoetin alfa will reduce the need for blood transfusions during the period of time around~     major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates~     red blood cell production.~   "
250743|NCT00270075|"~     The purpose of this study is to determine whether epoetin alfa will enable self-donation of~     at least 4 units of blood during the 2-week period before surgery (which is a shorter period~     of time than the conventional 3-week blood donation period before surgery) in patients who~     are not anemic and who will be undergoing orthopedic or heart and blood vessel surgery.~     Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.~   "
250744|NCT00270062|"~     The purpose of this study is to evaluate the safety of epoetin alfa and its effectiveness in~     facilitating the presurgical collection of blood from anemic patients for possible~     self-transfusion during and after scheduled joint surgery and its effectiveness in reducing~     surgery-related transfusion requirements. Epoetin alfa is a genetically engineered protein~     that stimulates red blood cell production.~   "
250745|NCT00270049|"~     The purpose of this study is to evaluate the effect of treatment with epoetin alfa versus~     placebo on the percentage of red blood cells in anemic patients with chronic lymphocytic~     (white blood cell) leukemia and its effect on the patients' quality-of-life. Epoetin alfa is~     a genetically engineered protein that stimulates red blood cell production.~   "
250746|NCT00270036|"~     The purpose of this study is to determine the safety of epoetin alfa and to determine the~     effectiveness of epoetin alfa in reducing the need for blood transfusions after major~     orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red~     blood cell production.~   "
250747|NCT00270023|"~     The purpose of this study is to determine the safety and effectiveness of epoetin alfa and~     whether epoetin alfa will enable self-donation of blood during an 11-day period before~     surgery (which is shorter than the conventional 3-week blood donation period before surgery)~     in patients who are not anemic and who will be undergoing orthopedic, heart and blood vessel,~     or breast reduction surgery. Epoetin alfa is a genetically engineered protein that stimulates~     red blood cell production. Normovolemic hemodilution (NVHD, withdrawal of a patient's blood~     immediately before surgery, immediate replacement of blood with an equal volume of fluid, and~     return of the withdrawn blood after completion of surgery; a procedure which reduces the loss~     of blood during surgery) will also be performed.~   "
250752|NCT00269958|"~     The purpose of this study is to evaluate the safety and effectiveness of two different dosing~     schedules of epoetin alfa versus placebo for decreasing the need for blood transfusions and~     preventing the occurrence of severe anemia during the period of time around total hip~     replacement surgery. Epoetin alfa is a genetically engineered protein that stimulates red~     blood cell production.~   "
250753|NCT00269945|"~     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus~     placebo for the treatment of anemia in AIDS (Acquired Immunodeficiency Syndrome) patients~     with anemia that is a result of this disease and zidovudine (AZT) treatment. Epoetin alfa is~     a genetically engineered protein that stimulates red blood cell production.~   "
250754|NCT00269932|"~     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an~     antibiotic, compared with cefuroxime axetil, another antibiotic, in the treatment of adults~     with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.~   "
250755|NCT00269919|"~     The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting~     injectable formulation of risperidone (an antipsychotic medication) and its influence on~     quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of~     emotional instability, detachment from reality, often with delusions and hallucinations, and~     withdrawal into the self).~   "
250756|NCT00269906|"~     The purpose of this study is to evaluate the safety and efficacy of abciximab, an~     anti-platelet therapy, versus placebo in patients with unstable angina who are not responding~     to standard medical therapy and who are eligible for coronary angioplasty.~   "
250757|NCT00269893|"~     The purpose of this study is to evaluate the effectiveness and safety of abciximab (an~     anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.~   "
250758|NCT00269880|"~     The purpose of this study is to compare the safety and effectiveness of abciximab, an~     anti-platelet therapy, versus placebo in patients undergoing percutaneous coronary~     intervention when administered in combination with two different heparin regimens. Please see~     attached results.~   "
250759|NCT00269867|"~     The purpose of this study is to evaluate the safety and effectiveness of infliximab (an~     anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis,~     despite methotrexate treatment.~   "
250760|NCT00269854|"~     The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric~     monoclonal antibody (cA2) compared to placebo in patients with active Crohn's disease.~   "
250761|NCT00269841|"~     The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric~     monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing~     Crohn's disease.~   "
250762|NCT00269828|"~     This is a randomized, open-label, multinational, phase III study in women with~     histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have~     PS 2. Study drug will be administered on day 1 of each 21 day cycle~   "
250763|NCT00269815|"~     The purpose of this study is to evaluate the long-term safety and effectiveness of OROSÂ®~     Methylphenidate HCl (a central nervous system stimulant) in children with attention deficit~     hyperactivity disorder (ADHD).~   "
250764|NCT00269802|"~     The purpose of this study is to evaluate the efficacy and safety of OROSÂ® Methylphenidate~     HCl as compared with placebo and standard immediate-release RitalinÂ® (taken three time per~     day) for the treatment of Attention Deficit Hyperactivity Disorder in children. Both OROSÂ®~     Methylphenidate HCl and RitalinÂ® contain the central nervous system stimulant,~     methylphenidate HCl.~   "
250765|NCT00269789|"~     The purpose of this study is to compare the effectiveness (onset of effect, time to loss of~     effect, and overall efficacy) of methylphenidate given as an OROSÂ® (methylphenidate HCl)~     formulation, compared to immediate-release RitalinÂ® and placebo for the treatment of~     Attention Deficit Hyperactivity Disorder (ADHD) in children using standardized attention and~     behavior scales, and other assessments. Both OROSÂ® Methylphenidate HCl and RitalinÂ® contain~     the central nervous system stimulant, methylphenidate HCl.~   "
250766|NCT00269776|"~     The purpose of this study is to provide data on the effectiveness of the OROS Methylphenidate~     Hydrochloride (HCl) formulation compared to placebo and standard immediate-release Ritalin~     with respect to improving attention and behavior, and decreasing hyperactivity in children~     with Attention Deficit Hyperactivity Disorder (ADHD). Both OROS Methylphenidate HCl and~     Ritalin contain the central nervous system stimulant, methylphenidate HCl. The safety~     associated with the two methylphenidate formulations will also be compared with placebo.~   "
250767|NCT00269763|"~     The purpose of this study is to establish the clinical utility and safety of fentanyl TTS (a~     transdermal patch delivering the narcotic pain reliever fentanyl) in the treatment of pain in~     patients with cancer.~   "
250768|NCT00269750|"~     The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that~     of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed~     urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the~     treatment of the symptoms of overactive bladder.~   "
250769|NCT00269737|"~     The purpose of this study is to evaluate the safety and effectiveness of continuous use of~     TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the~     treatment of chronic cancer pain.~   "
250770|NCT00269724|"~     The purpose of this study is to is to evaluate the safety and efficacy of OROS® oxybutynin~     chloride in patients being treated for urge urinary incontinence. Oxybutynin is an~     antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive~     bladder.~   "
250771|NCT00269685|"~     The purpose of this study is to compare the classical tactics in the treatment of septic~     shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice~     pressor.~      Vasopressin seems to be an interesting alternative in the treatment of septic shock. To this~     date, available studies have showed that it could correct hyperkinetic syndrome and~     vasoplegia in septic shocks without noticeable side effect. It as been demonstrated that~     vasopressin improves renal function, as no effect on digestive organs and as no metabolic~     effect.~   "
250867|NCT00268398|"~     PURPOSE: This randomized phase III trial is studying two different combination chemotherapy~     regimens to compare how well they work in treating patients with colorectal cancer and~     resectable metastases.~   "
250772|NCT00269672|"~     There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate~     vaccines enhances the immune response in infants. There is no data so far evaluating whether~     this also applies to adults. The objective of this study is to compare the immune response of~     2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to~     select a formulation and to compare the immune response to the chosen 13vPnC formulation~     relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).~   "
250773|NCT00269659|"~     A left bundle branch block (LBBB) is related to abnormal cardiac conduction and mechanical~     asynchrony and is associated with hypertension and coronary artery disease. Improved~     evaluation of left ventricular (LV) mechanical asynchrony is needed, because of the~     increasing number of patients with a LBBB and heart failure. A variety of patterns of~     mechanical activation can be observed in LBBB patients.~      Novel imaging modalities such as tissue Doppler imaging, real-time 3D echocardiography and~     cardiovascular magnetic resonance imaging provide information about regional and global LV~     function in healthy subjects, patients without a LBBB with heart failure, patients with a~     LBBB without heart failure, and patients with a LBBB with heart failure.~      The investigators want to evaluate the different patient groups with the novel imaging~     modalities and they want to compare the novel imaging modalities with each other.~      The investigators hypothesized that, between the groups, differences concerning regional and~     global LV function are measurable.~      Each novel imaging technique has its own advantages and limitations but are comparable in~     measuring regional and global LV function.~   "
250774|NCT00269646|"~     The purpose of this study is to compare the effects of a low-carbohydrate diet and a~     high-carbohydrate, high-fiber diet, on insulin sensitivity and blood chemicals considered~     risk markers for heart disease, in persons with the metabolic syndrome.~      Our primary hypothesis is that the ad libitum high-carbohydrate, high-fiber diet will~     significantly improve insulin sensitivity, whereas the ad libitum low-carbohydrate, low-fiber~     diet will not.~   "
250775|NCT00269633|"~     The specific aim of this study is to test the hypothesis that light stimuli concentrated~     around 467 nm will evoke a significantly stronger therapeutic response in SAD patients~     compared to light stimuli concentrated around 657 nm at an equal photon density.~      The secondary objective of this study is to determine the efficacy of different colors and~     levels of light in order to optimize therapeutic benefit, while also minimizing side effects~     and maintaining safety of light exposure.~   "
250776|NCT00269620|"~     This is an open-label prospective, multicenter, randomized trial to compare continuation~     rates into the fourth cycle of women using either the NuvaRing or OrthoEvra. Five hundred~     women will be recruited at 9 centers nationwide to be randomly assigned to use either the~     NuvaRing or OrthoEvra for four months. Women must either be on the pill or have recently~     stopped the pill and be relatively satisfied with oral contraceptive use to qualify for~     enrollment. Two visits and two phone calls will be required.~   "
250777|NCT00269607|"~     The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants~     as relapse prevention for patients that are completing treatment for opiate addiction in~     inpatient (or similarly controlled) settings. Participants in the naltrexone experimental~     group are prematched in a pairwise fashion with other patients who do not want a naltrexone~     implant during the first six months after ending inpatient treatment, but who reiceive~     treatment as usual (TAU) from the Norwegian healthcare system.~      The hypotheses are that quality of life, depression, opioid use, will be significantly better~     in the naltrexone group compared to the non at 6-, 12-, and 18-month follow-up.~      We also hypothesize that the implants can prevent death from opioid overdose up to 6 months~     after commenced treatment.~   "
250778|NCT00269594|"~     The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic~     excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label~     treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and~     well tolerated in patients with neurotic excoriation. The proposed study will provide needed~     data on the treatment of a disabling disorder that currently lacks a clearly effective~     treatment.~   "
250779|NCT00269581|"~     Purpose of this study is to determine if a CD-ROM computer program (called Headstrong) is~     effective in helping children cope with chronic headaches.~   "
250780|NCT00269568|"~     This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an~     intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate~     in this prospective clinical trial. This study will provide an evaluation of oral~     mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up~     to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7~     and 14 days after misoprostol administration, when using mifepristone 200 mg orally and~     misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up~     to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as~     acceptability will be done using pre and post-study questionnaires, and visual analogue~     scales. Complete abortion rate within 24 hours is expected to be 90%~   "
250781|NCT00269555|"~     Genistein Combined Polysaccharide (GCP) is derived from adding soy powder to shiitake~     mushrooms. This concentrated mixture is currently being sold in Japan and the United States~     and is thought to possibly contain properties that may be useful in treating certain types of~     cancer.~   "
250782|NCT00269542|"~     Children, aged 1 months to 23 months, in the intervention households received zinc, iron and~     folic acid and those in the control households were administered iron and folic acid (IFA)~     alone for a period of one year. The primary outcomes were hospitalizations and deaths during~     this period.~   "
250783|NCT00269529|"~     The study aims to compare two different kinds of pain treatment after total knee replacement~     (operation with artificial knee joint): 1) a large local injection in and around the knee,~     supplemented with injection the day after, or 2) the department's conventional pain treatment~     consisting of continuous nerve block in the groin.~   "
250784|NCT00269516|"~     This study is a multicenter, randomized, double blind, parallel group study of 6 months'~     treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open~     label safety extension to this study is planned as a separate protocol for patients who are~     willing and eligible to participate.~   "
250785|NCT00269503|"~     Back pain is a major cause of disability in the United States. The lifetime prevalence of low~     back pain is estimated at 60-90%. Back pain has conservatively been estimated to involve~     total direct and indirect costs of over $25 billion annually in lost wages, treatment, and~     related issues. These losses clearly extend to the active duty population cared for by~     military health care facilities.~      Chiropractic medicine is characterized by the use of a number of physical manipulations and~     mobilization techniques, which can be used singly or in combination to treat a variety of~     medical conditions. Although basic clinical practice guidelines for Chiropractic have been~     developed, few studies have rigorously compared techniques and their outcomes for specific~     conditions. Fewer still have sought to correlate treatment modality with both anatomical~     effect and clinical outcome.~      Throughout the military, Chiropractic care is available only to active duty personnel and~     only at a limited number of medical treatment facilities. At National Naval Medical Center,~     it is a well-established treatment option, where the full array of techniques is employed,~     primarily for painful conditions, and most often for back pain. This study seeks to clarify~     the mechanisms of action and efficacy of one specific treatment option, prone distraction,~     for the relief of subacute sciatica due to radiographically confirmed herniated disc, and to~     compare it to side-posture manipulation and standard medical management.~      Prone lumbar distraction utilizes a specialized table with motorized continual motion~     distraction. This table has multiple mechanical articulations that can be used to place~     patients in a wide variety of positions. Patients being treated with continuous motion~     distraction are placed prone with the table positioned for maximum comfort and centralization~     of symptoms.~      Side posture manipulation is a widely practiced, standard chiropractic technique, which has~     been shown to provide considerable clinical improvement for patients with sciatica. Low-~     grade oscillatory stresses are performed within the physiological range of normal joint~     motion. The hip, pelvis and lumbar spine are rotated forward with manual pressure while a~     counter rotation of the chest and thoracic spine is applied.~   "
250786|NCT00269490|"~     The purpose of the proposed research is to conduct a feasibility study of yoga as an~     adjunctive therapy for the treatment of posttraumatic stress disorder (PTSD) in 15 military~     personnel at the Walter Reed Army Medical Center (WRAMC) in Washington, DC. Participants will~     complete 10 weeks of yoga training, in addition to the continuing their usual and customary~     care for PTSD at WRAMC. The style of yoga chosen for this study, Yoga Nidra, uses deep~     relaxation, deep breathing and meditation to systematically reduce physical, emotional,~     mental, and even subconscious tension. After a diagnostic mental health assessment at~     baseline, participants will attend a total of 18 classes taught over a 10-week period and~     will practice daily at home using a compact disk provided by the instructor. Baseline~     measures will include the Patient Health Questionnaire, PD-HAT Trauma Questions, PTSD Symptom~     Scale - Interview, Fear of Loss of Vigilance Scale, and expectation of efficacy. The primary~     outcome measure will be the PTSD Checklist. Changes in health status, locus of control, and~     pain will be assessed over the course of the study. An additional goal of this study is to~     gather preliminary data on the anticipated effect size and feasibility of conducting a larger~     clinical study of the adjunctive use of yoga for the treatment of PTSD symptoms in enlisted~     military personnel.~   "
250787|NCT00269477|"~     The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged~     15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study~     MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the~     antibody response will be evaluated in a subset of these participants who will receive a~     booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who~     have not been previously vaccinated with a meningococcal vaccine or had documented meningitis~     disease who will also receive a dose of Menactra® vaccine.~   "
250788|NCT00269464|"~     Evaluating the prevalence and characteristics of obsessive-compulsive (OC) symptoms in~     patients with chronic schizophrenia~   "
250789|NCT00269451|"~     Assessing the prevalence and natural course of PTSD after the 1999 Turkish earthquake~   "
250790|NCT00269438|"~     The purpose of this study is to establish the efficacy and safety of a new tablet formulation~     and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical~     improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of~     therapy.~   "
250791|NCT00269425|"~     The purpose of this study is to determine whether a Mediterranean style diet, enriched in~     monounsaturated and omega-3 fats, is superior to the American Heart Association Step 2 diet,~     a traditional low fat diet, for improving rates of survival and cardiovascular complications~     in persons who have had a first myocardial infarction (heart attack).~   "
250792|NCT00269412|"~     This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects~     will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550~     mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional~     two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will~     receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to~     treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase~     that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the~     Post-treatment Phase will be discontinued from the study.~   "
250793|NCT00269399|"~     The purpose of this study is to assess the treatment and safety of a 10-day course of~     rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium~     difficile-associated diarrhea (CDAD).~   "
250794|NCT00269386|"~     Clarithromycin may be an effective therapy in Crohn's disease. It is a broad spectrum~     antibiotic. Crohn's disease, the investigators think, is in some way related to bacteria,~     which reside in the bowel.~      Previous studies of different types of antibiotic in Crohn's disease have shown encouraging~     results. Clarithromycin alters the bacteria in the bowel and gets into cells in the bowel~     which may contain bacteria. There is some evidence that clarithromycin can stimulate the~     immune system and improve the function of cells involved in killing bacteria in the bowel.~   "
250795|NCT00269373|"~     Is PET-CT scan better than PET or CT alone in diagnosing primary tumours in patients with~     unknown primary tumors? Can information obtained with PET-CT replace other clinical and~     radiological investigations? Is PET/CT cost-effective?~   "
250796|NCT00269360|"~     The purpose of this study is to compare three treatments for neck pain: 1) rehabilitative~     exercise, 2) chiropractic spinal manipulation combined with rehabilitative exercise, and 3)~     self-care education.~   "
250797|NCT00269347|"~     The broad, long term objective of this interdisciplinary research is to identify effective~     therapies for low back pain sufferers and to increase our understanding of this important~     condition. The primary aim is to examine the relative efficacy of chiropractic spinal~     manipulation, rehabilitative exercise, and self-care education in terms of patient-rated~     outcomes in the short and long term for non-acute low back pain.~   "
250957|NCT00267176|"~     This study will investigate the effect on ambulatory blood pressure of lumiracoxib 100 mg~     once daily versus ibuprofen 600 mg three times a day in osteoarthritis patients with~     controlled hypertension.~   "
250798|NCT00269334|"~     The study includes two components：(1) cross-sectional (Study I), and (2) longitudinal~     treatment trial (Study II). The cross-sectional component will include all subjects initially~     recruited for the parent project. Genotyping characteristics will be compared with clinical~     status (i.e., recovered vs symptomatic). The treatment trial component (one) will include a~     subset of the subjects (n = 400) who remain significantly depressed. They will be randomly~     assigned to 8-weeks of treatment with either citalopram or paroxetine. With such a design, we~     wish to test the following hypotheses：~      Ⅰ. Depressed patients with the short variant of the serotonin transporter (5HTTLPR) will~     respond faster and better to antidepressants compared to their counterparts with the long~     variant. Concurrently, patients with the 5-HTT Stin2 12/12 allele will also show better~     response as compared to those with the 10/12 allele.~      Ⅱ. Depressed patients who are homozygous for deficient or less active CYP2D6 or CYP2C19~     enzyme(s) will be more likely to show treatment emergent side effects compared to subjects~     with the wildtype alleles. Specifically, in Study II, CYP2D6 polymorphism will predict PAR~     but not CIT side effects and CYP2C19 polymorphism will be associated with CIT but not PAR~     side effects.~   "
250799|NCT00269321|"~     The purpose of this randomized clincal trial is to assess the relative effectiveness of three~     conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic~     manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home~     exercise alone.~   "
250800|NCT00269308|"~     The purpose of this randomized clinical trial is to assess the relative effectiveness of~     three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic~     manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home~     exercise alone.~   "
250801|NCT00269295|"~     The purpose of this research study is to determine whether a new vaccine for typhoid fever is~     safe and effective. This study will also look at what effects (good and bad) this new~     vaccine, Ty800, has on the volunteers. The study will determine the highest dose of Ty800~     that can be given without causing severe side effects. About 54 healthy males and females,~     ages 18-45 inclusive, in the Cincinnati metropolitan area will be enrolled in this study.~     They will be in the study for approximately 7 months, which includes a one month screening~     period, study product administration on Day 0, a 10-day hospital stay, an outpatient period~     on Days 9-28 with 4 follow-up visits, and safety follow-up phone calls at 2 and 6 months~     after hospital discharge. Researchers hope that this trial will help produce a vaccine that~     combines a high level of durable protective immunity with simplicity of administration and~     minimal reaction to the vaccine.~   "
250802|NCT00269282|"~     The purpose of this study is to determine the effectiveness of two home-based asthma~     interventions in increasing adherence to daily asthma controller medication.~   "
250803|NCT00269269|"~     To compare the unconditioned and conditioned effects of placebo capsules in the treatment of~     patients with borderline hypertension (BH).~   "
250804|NCT00269256|"~     The purpose of this study is to evaluate the multiple mechanisms through which stress,~     physical environment, and genetic predisposition contribute to asthma in urban children.~   "
250805|NCT00269243|"~     Angiotensin converting enzyme (ACE) inhibitors have been shown to improve survival and to~     reduce the risk of cardiovascular events in some groups of patients following myocardial~     infarction. This study is designed to test whether early initiation (≤7 days) of an ACE~     inhibitor post-coronary artery bypass graft (CABG), would reduce cardiovascular events. The~     trial was a double-blind, placebo controlled study of 2,553 patients randomly assigned to~     quinapril, target dose 40 mg daily or placebo, followed up to 43 months.~   "
250806|NCT00269230|"~     People who have abnormal heart beats, or whose heart does not beat on its own, may need an~     electronic device called a pacemaker or a defibrillator. Furthermore, people whose hearts~     have a reduced pumping ability may need a device are called cardiac resynchronization therapy~     (CRT) device. A CRT device is implanted surgically just under the skin in the upper chest~     area. This device then helps the heart beat at a regular rhythm by sending electrical signals~     (pacing) directly to the heart tissue through flexible wires called leads. The device may~     also be able to stop the heart from beating too fast. Three leads are implanted into the~     chambers of your heart. Two of the leads will be placed on the right side of your heart. The~     third lead is placed on the left side of your heart and is the lead being studied.~      The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM~     Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics~     that may help to better keep it in position once it is implanted into the left ventricle. It~     is also steroid-eluting which means that over time it slowly releases a small amount of~     medication into the heart tissue to help prevent too much swelling around the area it is~     implanted.~   "
250807|NCT00269217|"~     This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed~     hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6~     scheduled clinic visits, and 7 treatment arms.~   "
250808|NCT00269204|"~     A 28-week clinical trial in patients with primary hypercholesterolemia or mixed~     hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9~     scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of~     the 3 treatment groups.~   "
250809|NCT00269191|"~     This study was conducted to assess the safety and tolerability of the drug and to evaluate~     its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.~   "
250810|NCT00269178|"~     Health promotion in schools aims to improve the health and well being of students by~     empowering them with the knowledge, skills and confidence to take responsibility for their~     own health. We incorporated a malaria component to an established peer health education~     programme in schools in The Gambia, and evaluated its impact on knowledge attitudes and~     practice (KAP) of school students and their families using a cluster randomized design. Since~     malaria is a particular problem among children under 5 and pregnant women, students were~     encouraged to explain what they learned to their families, and we sought to evaluate whether~     the malaria messages were taken up by the students' families. Evaluation endpoints are KAP in~     students, and KAP in women living in the school students' home compound.~   "
250811|NCT00269165|"~     This study will examine the effect of external beam radiation therapy in the prevention of~     restenosis following successful balloon aortic valvuloplasty in severe, symptomatic aortic~     stenosis.~   "
250812|NCT00269152|"~     This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility~     study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as~     adjuvant combination-chemotherapy in participants with completely resected, stage Ib or~     IIa/IIb non-small cell lung cancer (NSCLC).~      A two-stage design will be employed independently for both treatment arms, with the~     possibility of stopping each treatment early for lack of feasibility.~   "
250813|NCT00269139|"~     Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in~     patients with borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD).~     The term behavioral crisis is used strictly for periods of uncontrollable urges to repeat~     mental or outward activity, e.g., flashbacks, cutting, binging on food, drugs or sex, with no~     intervals to rethink one's priorities or to consider others' direction.~      The clinical hypothesis states, in two steps, that:~        1. the perception of a life crisis precedes and then underlies every behavioral crisis;~        2. the behavioral crisis resolves promptly and all symptoms end if the clinicians engage~          the patient about his management of the life crisis that underlies the symptoms.~   "
250814|NCT00269126|"~     This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary~     Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times.~     Subjects will be given breathing tests, and will record their breathing symptoms daily on~     diary cards.~   "
250815|NCT00269113|"~     This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the~     East German Study Group for Hematology and Oncology versus standard chemotherapy plus~     MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and~     mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target~     sample size is 100-500 individuals.~   "
250816|NCT00269100|"~     The purpose of this study is to analyse bacteremia induced by debridement of pressure ulcers~     in patients in the complex nursing department.~   "
250817|NCT00269087|"~     This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease).~     This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects~     will be given breathing tests, and will record their breathing symptoms daily on diary cards.~   "
250818|NCT00269074|"~     Primary objectives: effect of IDEA-070 compared to placebo on pain and inflammation induced~     by PDT. The primary objective is to detect a statistically significant difference of pain and~     inflammation induced by PDT in test areas treated with IDEA-070 compared to placebo-treated~     areas.~   "
250819|NCT00269061|"~     This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid~     volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their~     current diabetic regimen.~   "
250820|NCT00269048|"~     This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or~     CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma~     Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated~     with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of~     SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to~     double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will~     then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once~     daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs,~     electrocardiograms, clinical laboratory safety tests and adverse event assessments will be~     performed to evaluate the safety and tolerability of SB-480848.~   "
250821|NCT00269035|"~     This study is being conducted in 2 groups of schizophrenic patients: in group 1 the~     relationship between the dopaminergic D2 receptor occupancy (D2 RO ) and serotoninergic 5HT2A~     receptor occupancy at stable plasma concentration (Cp) of SB-773812 will be investigated~     using SPECT scan in up to 15 chronic schizophrenic patients in an open- label design. In~     group 2 up to 80 patients will receive SB-773812 or Risperidone for 6 weeks to obtain at~     least 10 patients showing clinical improvement with SB-773812. The relationship of D2 RO,~     measured at steady state after chronic dosing at Cmax (6+/-2 h) and Ctrough (24+/-4 h), and~     PK at steady state after repeated doses, to efficacy readouts will be investigated. The~     SB-773812 dose administered will be selected as the highest dose proven to be safe and well~     tolerated from a previous study.~   "
250822|NCT00269022|"~     Despite the success of the triptan class of drugs, approximately 60% of patients who take~     medication at the moderate to severe pain stage of acute migraine, still have pain of mild or~     greater degree at 2 hrs post dose. SB-705498 is a novel, first in class TRPV1 receptor~     antagonist under development for the treatment of migraine pain. Preclinical experiments have~     demonstrated that the TRPV1 receptor is expressed both centrally and peripherally in the~     trigeminal system and inhibition of TRPV1 with SB-705498 can both prevent and reverse~     established central sensitisation.~   "
250823|NCT00269009|"~     The investigators want to find out if providing a Community Health Educator Referral Liaison~     (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical~     inactivity, unhealthy diet, and risky drinking) by connecting patients to available services~     in the community or directly providing behavior change support.~   "
250824|NCT00268996|"~     IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented~     coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers,~     safety and tolerability.~   "
250844|NCT00268710|"~     Primary objectives:~        -  To determine the response rate, measurable and non measurable, to Taxotere® in the~          second line setting.~      Secondary objectives:~        -  To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as~          second line therapy in HRPC~        -  To evaluate PSA response (PSA: Prostate Specific Antigen)~        -  To evaluate symptomatic response~        -  To evaluate Quality of life~        -  To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.~   "
250845|NCT00268697|"~     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily~     (QD), taken with ezetimibe on cholesterol levels in subjects with primary dyslipidemia~   "
250958|NCT00267163|"~     The goal of this project is to determine if a cholinesterase inhibitor is more effective than~     placebo in delaying cognitive and brain functional decline in people at risk for Alzheimer's~     disease.~   "
250825|NCT00268983|"~     Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen (Tositumomab and~     Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen, formerly called Iodine-131~     Anti-B1 Antibody) in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will~     be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly~     assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2~     (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm~     B, subjects will undergo a two-phase treatment. In the first phase, termed the dosimetric~     dose, subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately~     followed by an infusion of 5 millicuries (mCi) (0.18 gigabecquerel [GBq]) of Iodine 131~     Tositumomab (35 mg). Whole body gamma camera scans will be obtained three times (Day 0; Day~     2, 3, or 4; and Day 6 or 7) following the dosimetric dose. The information derived from the~     scans will enable a patient specific dose to be calculated to deliver the desired total body~     dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the therapeutic~     dose, subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg)~     immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated~     Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric~     dose and continued for 14 days following the therapeutic dose. Subjects on study will be~     followed for response and safety at Week 7, Week 13, and every three months for the first and~     second year, every six months for the third year, and then annually for the forth and fifth~     years; and then for vital status, additional therapy, and long term safety events through~     year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of~     next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia~     (AML), HAMA or hypothyroidism, unexpected safety issues, and death.~   "
250826|NCT00268970|"~     The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel~     in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).~   "
250827|NCT00268957|"~     Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered~     into this study at approximately 26 centers in the United States. This study aims to evaluate~     the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest~     meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals.~     The total length of participation is approximately 24 weeks.~   "
250828|NCT00268944|"~     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The overall objective is to evaluate the safety and efficacy of rhGAA in~     patients with advanced Late-onset Pompe disease.~   "
250829|NCT00268931|"~     The specific purpose of this study is to determine the effect of movement training on the~     onset of motor skills in babies born prematurely. We hypothesize that infants who participate~     in movement training will show advances in motor skills, visual attention, and toy-oriented~     behavior.~   "
250830|NCT00268918|"~     The main purpose of this study is to see if the study drug, PTK787, is safe and to find the~     highest dose that can be given safely without causing serious side effects.~   "
250831|NCT00268905|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and to explore the~     safety and anti-tumor activity of E7389 in combination with carboplatin in patients with~     advanced solid tumors.~   "
250832|NCT00268892|"~     The purpose of this extension study was to collect long-term safety and tolerability~     information to support a marketing authorisation application for a three-month dosage regimen~     of degarelix.~   "
250833|NCT00268879|"~     The purpose of the study is to investigate whether renzapride will help alleviate the~     symptoms associated with constipation predominant irritable bowel syndrome in female~     patients.~   "
250834|NCT00268866|"~     Danish Quality Assurance Project on Diagnosis and Treatment of COPD in Outpatient Lung~     Clinics~   "
250835|NCT00268853|"~     The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide,~     Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting~     Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.~   "
250836|NCT00268840|"~     The purpose of this study is to assess the efficacy of combination therapy with gemcitabine~     and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary~     adenocarcinoma.~   "
250837|NCT00268827|"~     The purpose of this study is to compare Kaletra tablets with Kaletra soft-gel capsules to see~     if there is any change in the side effects you may have and to see how people in the study~     feel about using the tablets.~   "
250838|NCT00268814|"~     The study will test the hypotheses that heroin assisted treatment, compared to methadone~     maintenance treatment, is more effective with regard to~        -  the improvement of health,~        -  reduction of illicit drug consumption,~        -  decrease of criminal behaviour,~        -  rise in the accessibility and retainment,~        -  detachment from a social drug context,~        -  social stabilisation in the sense of new drug-free contacts, improved vocational~          circumstances, financial security, stabilisation of the living situation,~        -  enrollment in subsequent treatment in the case of heroin dependent persons who could not~          be effectively reached or successfully treated so far, and it will check which is the~          optimal treatment setting with regard to these aims.~      The medication is injectable pure heroin (diacetylmorphine) 3x/d, or d l methadone 1x/d~      The study design is multicentre, open, randomised, 4 x 2 stratified. The study duration is 24~     months (individual period of investigation), 1. study phase: 12 moths (protocol part B) and~     2. study phase: 12 moths (part C). Patients recruited have an opiate dependency according to~     ICD-10, who are not being treated currently or who are in a methadone maintenance programme~     with an unsatisfactory course of treatment.~   "
250839|NCT00268788|"~     The purpose of this study is to evaluate the effect of subcutaneous administration of~     immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy~      NB. ONLY RECRUITING FROM DENMARK~   "
250840|NCT00268775|"~     The purpose of this study is to compare the effect of two implementation strategies for a~     simple patient-directed intervention to reduce long-term benzodiazepine use in Dutch~     community pharmacies.~   "
250841|NCT00268762|"~     Is the combination of low doses of argatroban in combination with rt-PA safe, and does it~     increase recanalization in patients with acute ischemic stroke.~   "
250842|NCT00268749|"~     This is an open label trial of the NMDA agonist glycine used alone for symptoms that appear~     to be prodromal for schizophrenia in adolescents and young adults.~   "
250843|NCT00268723|"~     To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be~     effective in the prevention of EIB and be safe and well-tolerated.~   "
250846|NCT00268684|"~     The objectives of the study is to determine if either temozolomide or erlotinib combined with~     WBRT and SRS improves survival as compared to WBRT and SRS alone.Ptients with histologically~     confirmed NSCLC with the presence of 1-3 intraparenchymal brain metastases will be randomized~     to 3 arms. All of the patients will receive WBRT and SRS. The patients of the arm 1 will~     receive radiation treatment only, the arm 2 patients will be treated with temozolomide and~     arm 3 patients will receive erlotinib~   "
250847|NCT00268671|"~     Study Objectives:~        -  To determine the MTD (maximal tolerated dose) and recommended dose of a weekly docetaxel~          and cisplatin combination regimen for locoregional recurrent/metastatic Squamous Cell~          Carcinoma of the Head and Neck (SCCHN)~        -  To determine the response rate of the recommended dose~        -  To determine the safety and tolerability of the recommended dose~   "
250848|NCT00268658|"~     The purpose of this study is to evaluate the effectiveness of the biofeedback gait training~     device in improving load bearing over an operated limb, during post-operative gait training~     therapy. The effectiveness of the device will also be tested in self-training at home.~   "
250849|NCT00268645|"~     The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in~     daily practice and to improve the physicians' knowledge and experience concerning Insulin~     glargine~   "
250850|NCT00268632|"~     The primary objective of this study is to assess the impact of physician's reinforcement~     using bone marker data on the subject's compliance (at least 50% drug taken) and persistence~     on treatment after one year in postmenopausal osteoporotic women.~   "
250851|NCT00268619|"~     Study objectives:~        -  To demonstrate that the acute administration of ramipril will control the inflammation~          process in patients with high-risk Acute Coronary Syndrome (ACS) as assessed by the high~          sensitivity C-reactive protein blood levels.~        -  To demonstrate that the normalization of blood glucose levels with intravenous insulin~          will improve the inflammation process during the acute phase of an ACS as assessed by~          Tumor necrosis factor alpha blood levels.~   "
250852|NCT00268606|"~     The present study is a new approach of examining tailored cognitive-behavioral interventions~     for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with~     respect to cognitive-behavioral risk factors and these patients are offered tailored~     cognitive-behavioral treatment options. It is expected that this approach will result in~     increased magnitude and maintenance of effects.~   "
250853|NCT00268593|"~     Docetaxel (Taxotere) is an approved chemotherapeutic drug for the treatment of~     androgen-independent prostate cancer. The aim of the study is to investigate whether addition~     of the investigational drug PI-88 will increase the efficacy of docetaxel in this disease.~     PI-88 inhibits cancer growth by inhibiting the development of new blood vessels and starving~     the tumour of oxygen and nutrients (anti-angiogenic). Because PI-88 and docetaxel have~     different mechanisms of action, they are expected to have increased (synergistic) activity~     when combined.~   "
250854|NCT00268580|"~     The purpose of the study is to evaluate whether the Emergency Department (ED) Asthma Care~     Project (ACP) leads to improved asthma care delivery and patient outcomes in the ED setting.~      Hypothesis: Implementation of a multi-disciplinary asthma strategy/clinical pathway for the~     treatment of asthma in the ED, based upon the 1999 Canadian Asthma Consensus Guidelines (and~     subsequent updates), will increase adherence with published management guidelines in the ED~     setting, reduce variations in the emergency management of acute asthma, increase utilization~     of specialized asthma services and improve outcomes for patients following ED visits.~      Methods:~      This observational, pre- post-intervention study will compare a stratified sample of 10~     Ontario hospital EDs (5 intervention and 5 control sites). Chart abstractions will be~     performed on all adult visits for acute asthma over a 3 month period before and after~     implementation of the Ontario Hospital Associations (OHA)'s (now Ontario Lung Association's~     (OLA's) ED Asthma Care Map. Patient and provider surveys and provider focus group post~     intervention will also be conducted. Primary outcome measures are hospitalizations and repeat~     ED visit rates. Secondary outcome measures include: length of stay in ED, self-reported~     adherence with referral to specialized asthma services made during index ED visit,~     self-reported asthma control, and use of self-management strategies (including use of action~     plan), use of asthma management strategies promoted by the care map (such as use of objective~     measure of airflow rates, use of steroids, education, referral to specialized asthma services~     on discharge). Ease of implementation and barriers to implementation will also be evaluated.~   "
250855|NCT00268567|"~     lupus nephritis accounts for the most morbidity and mortality in patients with SLE.~     Glucocorticoids combined with cyclophosphamide (CYC) are effective for the treatment of~     patients with proliferative lupus nephritis and have been the immunosuppressive regimen of~     choice for many years. However, some patients do not respond well to the regimen, and adverse~     effects of cyclophosphamide limit its use in certain patients. Leflunomide is a novel~     immunosuppressive agent currently used in the treatment of rheumatoid arthritis.There were a~     few pilot observational studies and reports suggesting leflunomide was also safe,~     well-tolerated and may be effective in SLE patients without important organ involvement. It~     has not been shown if leflunomide can be used in the treatment of patients with lupus~     nephritis. We therefore undertook a multi-center, controlled study to investigate the~     efficacy and safety profile of leflunomide compared with cyclophosphamide in the treatment of~     patients with biopsy proven proliferative lupus nephritis.~   "
250856|NCT00268554|"~     The purpose of this study is to determine whether dipyridamole enhances postocclusive~     reactive hyperaemia by increasing extracellular adenosine concentrations during ischemia and~     reperfusion. Furthermore we hypothesize that dipyridamole augments postocclusive reactive~     hyperaemia by increasing adenosine receptor stimulation.~   "
250866|NCT00268411|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It~     is not yet known whether giving both of these drugs on the same day is more effective than~     giving them on different days.~      PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine~     and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic~     cancer.~   "
250857|NCT00268541|"~     Offspring of patients with type 2 diabetes have increased risk of developing diabetes and are~     typically more insulin resistant than their peers with no diabetes family history. We have~     recently demonstrated that, in contrast to their sedentary counterparts, physically active~     offspring are not insulin resistant. In the proposed controlled clinical study, we will~     examine the effects of a moderate exercise programme on insulin resistance, and other~     metabolic risk factors, in sedentary offspring and matched control subjects. We hypothesise~     that offspring will exhibit an augmented response to exercise, thereby normalising their~     predisposition to an adverse metabolic profile. We will also investigate expression of~     adipokines and other genes in adipose tissue to determine whether these contribute to the~     increased insulin resistance observed in offspring and whether they are influenced by~     exercise. The results will help to determine the efficacy of exercise in normalising~     metabolism in offspring and will help elucidate the mechanisms involved.~   "
250858|NCT00268528|"~     This clinical trial is assessing compliance with long-term mercaptopurine treatment in young~     patients with acute lymphoblastic leukemia in remission. Assessing why young patients who~     have acute lymphoblastic leukemia may not take their medications as prescribed may help~     identify ways to assist them in taking their medications more consistently and may improve~     long-term treatment outcomes.~   "
250859|NCT00268515|"~     To evaluate the efficacy of aerosolized cyclosporine given in addition to the standard oral~     immunosuppressive drug regimen, in preventing acute rejection immediately after lung~     transplantation~   "
250860|NCT00268502|"~     RATIONALE: Studying quality of life in cancer survivors may help determine the long-term~     effects of breast cancer and may help improve the quality of life for future cancer~     survivors.~      PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian~     female breast cancer survivors.~   "
250861|NCT00268489|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium~     together with bevacizumab may be an effective treatment for non-small cell lung cancer.~      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with~     bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.~   "
250862|NCT00268476|"~     The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for~     the treatment of men with prostate cancer who are starting long-term ADT for the first time,~     termed hormone-naïve prostate cancer. This trial aims to see if we can improve the way in~     which prostate cancer is currently managed, either by adding new treatments to the standard~     approach or by modifying the type of hormone therapy aiming to improve quality-of-life by~     reducing the side effects of treatment. Each new treatment approach is compared against a~     control arm receiving the current standard treatments. We aim to identify treatment~     strategies that enable men to live longer, or as long but with an improved quality-of-life,~     as well as offering value for money for the health service.~      Since opening to accrual in Oct-2005, the trial has tested many ways of treating prostate~     cancer and some results are now already known. More than 10,000 men will join the trial with~     answers becoming available throughout the trial. New patients joining the trial from Protocol~     version 17.0 onwards (activated in December 2018) may be eligible to join one of two~     treatment comparisons, metformin (treatment group K; the metformin comparison) and~     transdermal oestradiol (treatment group L; the transdermal oestradiol comparison). A~     computer program will be used to allocate which treatment each participant receives, using a~     chance process.~      Summary of the research arms in STAMPEDE trial platform Summary of research treatment groups~     currently open to recruitment (June 2017)~        1. Metformin (Arm K): This anti-diabetic medication is proposed to have both anti-cancer~          effects and may help prevent the adverse metabolic effects of long-term ADT. STAMPEDE~          will investigate whether adding metformin to the current standard-of-care for~          non-diabetic men can improve all-cause survival.~        2. Transdermal oestradiol (Arm L): This is an alternative form of hormone treatment which~          has been shown to suppress testosterone as effectively as standard ADT and avoid some of~          the side-effects. It may also help to avoid the adverse metabolic effects and fatigue~          and therefore improve overall quality of life compared with standard forms of ADT.~          STAMPEDE will investigate whether transdermal oestradiol can treat the cancer as well as~          current standard forms of ADT.~        3. Control group (Arm A): Patients allocated to this group receive the current~          standard-of-care ADT +/- RT +/- docetaxel.~   "
250863|NCT00268463|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing~     substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different~     ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and~     capecitabine together with an hepatic arterial infusion with floxuridine is more effective~     than giving oxaliplatin and capecitabine alone in treating patients who are undergoing~     surgery and/or ablation for liver metastases due to colorectal cancer.~      PURPOSE: This randomized phase III trial is studying oxaliplatin, capecitabine, and an~     hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin~     and capecitabine in treating patients who are undergoing surgery and/or ablation for liver~     metastases due to colorectal cancer.~   "
250864|NCT00268450|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some find tumor cells and kill them or carry tumor-killing~     substances to them. Others interfere with the ability of tumor cells to grow and spread.~     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Giving combination chemotherapy together with bevacizumab before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving these~     treatments after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and~     gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with~     locally advanced nonmetastatic bladder cancer that can be removed by surgery.~   "
250865|NCT00268437|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving radiation therapy together with pemetrexed disodium and~     carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving radiation therapy together with~     pemetrexed disodium and carboplatin works in treating patients with locally advanced~     esophageal cancer that can be removed by surgery.~   "
250868|NCT00268385|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with temozolomide in treating patients with malignant gliomas. Drugs used in~     chemotherapy, such as vorinostat and temozolomide, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may~     also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Vorinostat may help temozolomide work better by making tumor cells more sensitive to the~     drug. Giving vorinostat together with temozolomide may kill more tumor cells.~   "
250869|NCT00268372|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It~     is not yet known whether giving combination chemotherapy together with radiation therapy is~     more effective than giving cisplatin together with radiation therapy in treating cancer of~     the oropharynx.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy and radiation~     therapy to see how well they work compared to cisplatin and radiation therapy in treating~     patients with stage III or stage IV cancer of the oropharynx.~   "
250870|NCT00268359|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such~     as irinotecan, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may~     kill more tumors cells.~      PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving~     bevacizumab together with irinotecan works in treating patients with recurrent or refractory~     gliomas.~   "
250871|NCT00268346|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with~     recurrent or metastatic esophageal or gastroesophageal junction cancer.~   "
250872|NCT00268333|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving more than one drug (combination chemotherapy) together with radiation therapy may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with radiation therapy works in treating patients with recurrent metastatic colorectal~     cancer.~   "
250873|NCT00268320|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. When there are~     changes in the heart beat sometimes an implantable heart device is used to control the rate~     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of~     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be~     prescribed.~      People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,~     may be in need of an electronic device called an implantable cardioverter defibrillator~     (ICD).~      Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart.~     People with AT may experience symptoms such as heart palpitations (a racing or pounding~     feeling in the chest), shortness of breath, dizziness, fatigue or weakness.~      The purpose of this study is to study an investigational implantable device containing~     Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD)~     therapies (CRT+ICD device) in subjects who are at significant risk of developing atrial~     tachyarrhythmias.~   "
250874|NCT00268307|"~     The goal of this study is to determine the safety of giving a patient's own bone~     marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood~     vessels of the heart). Stem cells are simple cells produced by the bone marrow that can~     develop into many types of cells. It is possible that these cells will decrease the size of~     damage caused to the heart from a heart attack and increase the pumping efficiency of the~     heart; which can be decreased due to a heart attack. The stem cells will be taken from bone~     marrow and then given back into the heart vessels.~   "
250875|NCT00268294|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. When there are~     changes in the heart beat sometimes an implantable heart device is used to control the rate~     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of~     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be~     prescribed.~      People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,~     may be in need of an electronic device called an implantable cardioverter defibrillator~     (ICD).~      Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart.~     People with AT may experience symptoms such as heart palpitations (a racing or pounding~     feeling in the chest), shortness of breath, dizziness, fatigue or weakness.~      The purpose of this study is to characterize the impact of cardiac resynchronization therapy~     versus cardiac resynchronization therapy with atrial therapies on the incidence, duration and~     termination of atrial tachyarrhythmias.~   "
250876|NCT00268281|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. When there are~     changes in the heart beat sometimes an implantable heart device is used to control the rate~     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of~     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may~     be prescribed.~      Left Ventricular Capture Management (LVCM) refers to the overall method for determining left~     ventricular thresholds (level of energy needed to effectively pace the tissue in the lower~     left chamber of the heart) by measuring, analyzing, and adjusting energy delivered from the~     CRT device to the pacing lead.~      The purpose of the Left Ventricular Capture Management Software Download Clinical Trial was~     to evaluate the accuracy of the Left Ventricular Capture Management (LVCM) feature to support~     LVCM feature approval in future cardiac resynchronization therapy with defibrillation (CRT-D)~     devices~   "
250877|NCT00268255|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together~     with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation~     therapy when given together with gefitinib and to see how well they work in treating patients~     with inoperable stage I or stage II non-small cell lung cancer.~   "
250878|NCT00268242|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer~     cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     mitoxantrone works in treating patients with relapsed acute myeloid leukemia.~   "
250879|NCT00268229|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving imatinib mesylate together with daunorubicin~     and cytarabine may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate~     when given together with daunorubicin and cytarabine in treating patients with relapsed acute~     myeloid leukemia.~   "
250880|NCT00268216|"~     The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the~     survival of subjects with COPD and also assess the long term safety profile of this drug.~   "
250881|NCT00268203|"~     This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab~     (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or~     transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine~     I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain~     additional safety and efficacy information for this treatment regimen. Post study drug~     administration follow-ups will continue for up to ten years. These will include blood-work~     and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week~     13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years~     from the dosimetric dose and then annually thereafter through year 10. Thyroid function will~     be monitored annually during Long-term follow-up.~   "
250882|NCT00268177|"~     This study was designed to look at effects of salmeterol/fluticasone propionate compared to~     placebo on airway inflammation in patients with chronic obstructive airways disease~   "
250883|NCT00268164|"~     The purpose of this study is to determine whether the lactic acid bacteria  Lactobacillus~     acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12) is effective as~     maintenance treatment in ulcerative colitis.~   "
250884|NCT00268151|"~     The purpose of this study is to determine the most suitable dose of Oxaliplatin that can be~     safely given in combination with a low fixed dose of Capecitabine and a limited volume of~     radiation in patients with non-small cell lung cancer.~   "
250885|NCT00268138|"~     the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride~     concentration of 1.25% compared with placebo by determining prevention of white spot lesions~     in patients wearing fixed orthodontic appliances.~   "
250886|NCT00268125|"~     The purpose of this study is to demonstrate a betterment of the digestive symptomatology by~     the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.~   "
250887|NCT00268112|"~     Spontaneous resynchronization of dyskinetic segments of the left ventricle occurs after~     coronary bypass surgery in adults and has been shown in some children. It is, however,~     unknown what degree of dyskinesis is likely to be reversible in infants with ischemia from~     anomalous coronary arteries and what criteria would indicate that a resynchronization~     strategy of biventricular pacing might be needed.~      These questions need data from quantitative serial tissue Doppler observations of patients~     from pre-operative to late post-operative follow-up.~   "
250888|NCT00268099|"~     The primary aim of this study is to determine the optimal timing for repair of right-to-left~     shunt lesions such as Tetralogy of Fallot defects.~      The secondary aim being define the criteria for failing medical therapy.~   "
250889|NCT00268086|"~     The primary aim of this study is to determine the clinical and radiographic findings with~     constrictive pericarditis in the adult congenital population and determine the degree of~     right heart failure and dilation from pulmonary insufficiency in the presence of constrictive~     pericarditis~      The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and~     elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.~   "
250890|NCT00268073|"~     The records of all the patients that underwent the Norwood-Sano operation at Children’s~     Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be~     investigated. These patients will be compared with an equal number of consecutive cases~     treated by classic Norwood stage I operation in order to determine the incidence of~     neo-aortic valve insufficiency and the clinical outcome of these patients.~   "
250891|NCT00268060|"~     Infants with congenital long QT syndrome (LQTS) and 2:1 atrioventricular block (AVB) have~     been recognized as a clinical subset of children with LQTS.~      The purpose of this study is to describe the clinical course and outcome of a patient with~     congenital long QT syndrome (LQTS).~   "
250892|NCT00268047|"~     Clinical evidence reveals that some patients who undergo cardiac transplantation exhibit~     problems with pulmonary vascular resistance as well. In some studies, an increase in~     pulmonary vascular resistance has been used as an indicator for increased 3-day and 3-month~     mortality after heart transplantation2. In this study, the investigators would like to look~     at pulmonary vascular resistance in patients with a surgical history of the Fontan procedure~     followed by heart transplantation.~   "
250893|NCT00268034|"~     Collect data to support “standard of care possibility” of extracardiac repair with closure of~     intracavitary communication and plication of the aneurysm as probably safest surgical repair~     for left ventricular aneurysms.~   "
250998|NCT00266630|"~     The efficacy and safety of the extended treatment to patients with most recent episode manic~     or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be~     examined.~   "
250894|NCT00268021|"~     Automated implantable cardioverter defibrillators ,AICD, and Biventricular,BiV, Pacemakers~     have been shown in randomized trials to offer an advantage in adults with decreased~     ventricular ejection fraction, heart failure, spontaneous non-sustained ventricular~     tachycardia VT, inducible non-suppressible VT and the combination of low ejection fraction~     and prior myocardial infarction,14. Pediatric patients with a variety of different heart~     abnormalities are at high risk for life threatening arrhythmias and poor ventricular function~     or heart failure,16. Therefore, extrapolating this adult data, AICDs and BiV pacemakers have~     been used with increasing frequency in the pediatric and congenital heart disease population.~     Improvements in device size and lead design allows AICD and BiV implantation in the very~     young, in small size patients and in patients with complex cardiac anomalies,1. The use of~     BiV pacemakers and the patterns of AICD discharge are similar in young patients and in~     adults, suggesting that the risk of life threatening arrhythmia and heart failure are also~     similar,16. However, this patient population behaves differently from the adult population in~     the incidence of pacemaker complications, circadian arrhythmias,7, and more importantly, a~     relatively high incidence of complications related to AICD insertion, 8. There is a need for~     more studies to establish the risk-benefit ratio of these devices in the pediatric setting.~   "
250895|NCT00268008|"~     The primary objective of this retrospective study of valve replacement is to document~     long-term survival and occurrence of valve related complications such as described in the~     literature; anticoagulant related bleeding event , thromboembolic events, subacute bacterial~     endocarditis (SBE), structural failure or deterioration , valve thrombosis, explantation and~     reimplantation with reason, death and death cause, and cerebrovascular accidents either~     permanent or transient in nature.~      Secondary to this is the presumption that mechanical valves have a superior “life expectancy~     “ to bio-prosthetic valves. We plan to look at the time of freedom from re-implantation from~     different types of valves, factoring in patient age, size ,defect and risk factors.~      The information learned from this study may benefit future patients who undergo the Ross~     procedure by increasing our knowledge of safer and/or more effective techniques.~   "
250896|NCT00267995|"~     The Ross procedure has become the surgery of choice for aortic valve replacement in children.~     This consists of taking a child's own pulmonary valve (the autograft) and replacing the~     child's diseased aortic valve with the autograft. At times, this can involve either enlarging~     or reducing the diameter of the aortic annulus to make the valve fit properly. The patient's~     own pulmonary valve is then replaced, most typically with a human heart valve (a homograft).~     There has been some concern in the literature that as time goes on, the autograft will dilate~     and the patient will develop progressive aortic insufficiency.~      Since 1994, we have performed almost 50 Ross procedures in children and young adults.~     Contrary to many reports from the literature, we have not recognized a problem with autograft~     enlargement and progressive aortic insufficiency. One thing that we have done differently~     from other centers is that we have modified the insertion technique of the autograft into the~     native aortic root. This involves a second buttressing suture layer. Not only does this have~     the immediate effect of reducing bleeding complications, we postulate that it has the~     long-term effect of stabilizing the autograft and preventing aortic root dilatation.~      We hypothesize that this proximal buttressing technique for the Ross procedure has a two-fold~     benefit. Firstly, it reduces the amount of bleeding in the postoperative period. Secondly, it~     prevents late autograft root dilatation.~   "
250897|NCT00267982|"~     A retrospective chart review will be performed on 50 patients who received RFA for the~     treatment of EAT between August 1992 and August 2003 at Children's Healthcare of Atlanta.~      The use of the CARTO/Biosense catheter has improved outcomes with decreased radiation~     exposure to patients.~   "
250898|NCT00267969|"~     The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab~     (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.~   "
250899|NCT00267956|"~     The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275~     (ustekinumab) in patients with psoriatic arthritis.~   "
250900|NCT00267943|"~     The primary objective is to assess the efficacy and safety of the fixed dose combination of~     telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other~     antihypertensive therapies during open-label, long-term treatment.~   "
250901|NCT00267930|"~     This study is designed to evaluate the safety, tolerability and preliminary efficacy of~     vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours~     and less than 6 months duration~   "
250902|NCT00267917|"~     The objective of this trial is to compare the total and regional deposition of aerosol in the~     lungs and oropharynx of patients with COPD and known poor MDI inhalation technique following~     inhalation of Berodual? delivered via the Respimat? inhaler and Berodual? delivered via an~     HFA-metered dose inhal er achieved with their natural inhalation technique compared with~     taught optimal technique.~   "
250903|NCT00267904|"~     Objectives: Plasma levels of catechols have distinct meanings in terms of indicating~     functions of endogenous catecholamine systems. This Protocol is designed to enable ongoing~     quality assurance of diagnostic and research assays of catechols and their metabolites and to~     identify possible influences of demographic and anthropometric factors, dietary constituents,~     and conditions of sampling on reference values.~      Study Populations: The study population is healthy volunteers and people who are obese or~     have untreated hypertension.~      Design: Arm venous blood is drawn via an indwelling i.v. catheter from healthy volunteers~     across demographic and anthropometric spectra (age, gender, skin color, ethnicity, body mass,~     adiposity), to obtain quality control plasma and establish reference values for plasma levels~     of catechols and their metabolites. Non-invasive physiological measures are obtained~     concurrently. Levels of catechols and their metabolites are related to results of common~     clinical pathology tests. Subgroups of subjects are tested more than once, to assess dietary~     influences (cereal with milk, coffee) and conditions of sampling (temperature at the skin).~      Outcome Measures: The main non-experimental outcome is an ongoing pool of quality control~     plasma. The main experimental outcome measures are plasma concentrations of catechols and~     their metabolites, non-invasive physiological measures, and results of common clinical~     pathology tests. Subject groups are compared with respect to the above demographic and~     anthropometric factors. Effects of the experimental manipulations are assessed within~     subjects~   "
250904|NCT00267891|"~     This study will use functional magnetic resonance imaging (fMRI) to examine what happens in~     the brains of adolescents when they are exposed to violent media and how imagining aggressive~     behavior affects brain function. The study will measure physiological changes (such as the~     amount of electricity generated by the skin, heart rate, and breathing rate) related to these~     tasks during fMRI. MRI uses a magnetic field and radio waves to obtain images of body organs~     and tissues. For fMRI, the subject performs certain tasks during the MRI scanning to examine~     changes in the brain regions that are involved with those tasks. During the scan, the subject~     lies in a metal cylinder (the scanner), wearing earplugs to muffle loud noises that occur~     with the scanning.~      Healthy right-handed native English-speaking males between 14 and 17 years of age may be~     eligible for this study. Candidates are screened with a neurological examination and~     neuropsychological testing that includes questions about their feelings, experiences, and~     behavior, and tests of reading level and intelligence.~      Participants undergo fMRI and fill out questionnaires before and after the scanning. Some~     children are asked to play 20 minutes of video games before the test. During the scan, the~     child views short neutral video clips and video clips of people fighting or imagine~     self-defense situations. The child is asked to rate the video clips for their aggressive~     content or tell how he or she feels about the imagined situations. Two small straps are~     wrapped around the child's index and middle fingers to measure changes in the amount of~     electricity generated by the skin, and a strap at the ring finger measures the child's heart~     rate. A band around the child's chest records breathing rates.~      Children who cannot or do not want to undergo MRI testing may be asked to view commercially~     available video clips of people fighting and neutral video scenes, such as sports scenes.~     They are asked to rate them on their violent content and excitement, or to rate the video~     games they have played on their violent/nonviolent content and their popularity. In addition,~     the children fill out questionnaires about their media use and exposure to violence.~      All participating families are contacted by telephone 1 day and 2 weeks after the experiment~     for parents to answer questions about how the child has been doing and for the children to~     answer questions about their feelings.~   "
250905|NCT00267865|"~     This study will investigate the use of chemotherapy plus highly active antiretroviral therapy~     (HAART) in patients with AIDS-related primary brain lymphoma. None of the drugs used in this~     study are experimental, but chemotherapy plus HAART has not been established as a standard~     treatment in patients with AIDS. The chemotherapy regimen used in this study (see below) was~     chosen because it may be less toxic to immune cells called T-lymphocytes than most drug~     treatments for lymphoma.~      People with AIDS 18 and older and have primary brain lymphoma may be eligible for this study.~     Candidates are screened with a medical history and physical examination, MRI, CT and PET~     scans, cerebrospinal fluid studies, brain biopsy at tumor sites, if possible,~     electrocardiogram and blood tests.~      Participants undergo six 2-week induction treatment cycles of HAART plus chemotherapy with~     methotrexate, rituximab and leucovorin, followed by two 4-week consolidation treatment~     cycles using HAART, methotrexate and leucovorin, and then HAART alone. Rituximab is given by~     intravenous (IV, through a vein) day 1 of each cycle. Also on day 1 IV fluids are given to~     lower acidity in the urine to protect the kidneys from the methotrexate. On day 2,~     methotrexate is infused through a vein over 4 hours. Starting 24 hours after initiation of~     the methotrexate infusion, leucovorin is given every 3 to 6 hours (first IV and then possibly~     by mouth) until the drug decreases to a target level in the blood. HAART is begun as soon as~     possible. The specific HAART regimen for each patient is determined individually. All~     patients are hospitalized the first week of every 2-week treatment cycle for safety~     monitoring. In addition to HAART and chemotherapy, patients undergo the following tests and~     procedures:~        -  Intellectual functioning: Before starting treatment, patients are tested for their~          ability to understand basic concepts and coordination in order to be able to evaluate~          how the brain lymphoma affects thinking and concentration. After the lymphoma appears to~          have resolved, more formal and intensive tests are done. The intensive tests are~          repeated each year, and shorter, interim tests are done about every 6 months. Also, a~          specialist periodically monitors patients' understanding of HAART and the importance of~          this therapy.~        -  Blood tests: Blood is drawn every day during hospitalizations to measure methotrexate~          levels and to evaluate kidney and liver function and blood counts. Blood is also drawn~          before starting therapy, when the lymphoma disappears, 6 months after completing~          treatment, and any time it appears that the lymphoma may have recurred to test for~          Epstein-Barr virus (EBV), a virus that is almost always present in AIDS-related primary~          brain lymphoma.~        -  Imaging tests: Patients undergo magnetic resonance imaging (MRI) and positron emission~          tomography (PET) scans periodically to monitor the effects of treatment on the lymphoma.~          MRI scans are done after the 2nd, 4th, 6th, and 8th treatments, then every 2 months for~          three times, every 3 months for six times, every 6 months for four times, and then every~          year for 5 years, or sooner if there is a concern about the brain. PET scans are done~          after the first cycle, after the MRI suggests the lymphoma is gone, and then yearly.~        -  Lumbar puncture (spinal tap): This test is done to look for EBV in the cerebrospinal~          fluid (CSF). Under local anesthetic, a needle is inserted in the space between the bones~          in the lower back where the CSF circulates below the spinal cord and a small amount of~          fluid is collected through the needle. This test is done at the same times as the blood~          tests for EBV.~        -  Eye examinations: Patients' eyes are examined periodically because brain lymphoma can~          sometimes spread to the eye and because some people with AIDS-related primary brain~          lymphoma are at risk of certain eye infections.~   "
250906|NCT00267852|"~     This is an observational prospective, multicenter study. The aim of the study is to evaluate~     how the Italian population of patients are treated with early aggressive RA, defined by the~     Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol~     2003;21(Suppl. 31):S129-S132), in rheumatologic clinical practice and whether recent~     scientific evidence or new treatments available to rheumatologists can change their practice~     in a 2 year follow-up. The observation will primarily focus on the disease activity and~     clinical remission in patients who are receiving different treatment strategies. The primary~     goal is to define prevalence of clinical remission, according to the (Disease Activity Score)~     DAS 28 definition of clinical remission, in patients with early aggressive RA receiving~     different therapies at 1 year.~      Secondary objective are assessment of:~        -  Prevalence of Remission at the second year~        -  Disease activity at the first and second year.~        -  ACR 20%, 50%, 70% response at the first and second year.~        -  Quality of Life in patients with or without remission at the first and second year~        -  Safety Evaluations~   "
250907|NCT00267839|"~     The purpose of this study is to determine whether exercise training may impact relevant risk~     factors and health costs of community living women older 65 years.~   "
250908|NCT00267826|"~     Protocol Title: Immunopharmacological effects of Rituximab in atopic dermatitis~      Study Phase: Investigator driven study~      Study Design: Open-label, single center.~      Primary Study Objective: To determine the efficacy, safety and immunopharmacological effects~     of Rituximab (anti-CD20) administered as a 1000mg intravenous infusion on days 1 and 15 to~     patients with atopic dermatitis.~      Secondary Study Objective: To investigate key immunological parameters involved in the~     pathology of this common skin disease to interpret the clinical findings.~      Number of Patients: 6~      Study Population: Male and female patients, at least 18 years of age with atopic dermatitis,~     active inflammation, a severity score of 6-9 according to Langeland and Rajika.~      Treatment Group: Rituximab will be administered as 1000 mg infusion intravenously at day 1~     and 15, followed by a 24-week follow-up period.~      Visit Schedule: Screening Visit (within 28 days prior to Visit 1) Treatment visits (Visits~     days 1, 3, 8, 15, 17) Follow-up Visits (Visits weeks 4, 8, 12, 16, 20, 24)~      Visit 11/Early Termination Visit (if applicable) Visit 11 will serve as the Early Termination~     Visit for any patient who withdraws from the study between Visit 1 and 10.~      Efficacy Parameters:~      Clinical parameters:~      EASI Patient Assessment of Pruritus / Pruritus score Physician Global Assessment (PGA)~     Photography~      Laboratory analysis:~      Differential blood count Total IgE, specific IgE (aeroallergen panel) Immunophenotyping of~     PBMC Lymphocyte proliferation following pan-T stimulation with PHA Cytokine release from~     blood T cells following pan-T stimulation with PHA~      Skin tests Histopathology of skin biopsies~      Safety Parameters: Physical examinations; vital signs; selected blood chemistry, including~     liver function tests, creatinine; white blood cell count (WBC; including total lymphocyte~     count); platelets, lymphocyte subset analysis; complement, immunoglobulins (IgA, IgM, IgG,~     IgE), monitoring for infections; monitoring for concomitant therapies; monitoring for adverse~     events.~   "
250909|NCT00267813|"~     Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated~     craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion~     (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully~     treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic~     activity in response to smoking and neutral cues in Positron Emission Tomography using FDG.~   "
250910|NCT00267800|"~     The cause of most interstitial lung diseases (ILDs) is still unknown. Further research, for~     example to determine predisposing genetic factors, is therefore needed. A database with~     relevant clinical data and DNA/serum samples of ILD patients could facilitate future research~     on the cause of ILDs.~   "
250911|NCT00267787|"~     Study the Genetics of Anal Cancer~   "
250912|NCT00267774|"~     In this multicenter, international study we are evaluating two approaches to determine which~     coronary artery narrowings require stent placement in patients with multivessel coronary~     artery disease. Patients will be randomized to an angiographic strategy, where only coronary~     angiography is used to determine which lesions to stent or to a pressure wire strategy where~     fractional flow reserve, an index measured with the pressure wire, will be used to determine~     which lesions to stent. The primary outcome will be major adverse cardiac events at 1 year. A~     secondary outcome will be cost-effectiveness.~   "
250913|NCT00267748|"~     This trial has two parts. The purpose of the first part of the trial is to determine the~     doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in~     combination. This part is currently closed to enrollment.~      The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2~     schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying~     progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule.~     The trial will also determine the number of patients whose cancer responds to the treatments,~     whether life of patients can be extended, what the side effects are of the treatments, how~     bothersome disease or treatment-related symptoms are to patients, and whether tests can be~     found that will predict which patients may or may not respond to these treatments in the~     future.~   "
250914|NCT00267735|"~     The objective of this proposed 18-month exploratory research study is to help pregnant women~     weigh risks and benefits in a childbirth decision using the Preferences-Assessment Computer~     Module. Our hypothesis is that, after using this computer module, women will be more aware of~     the potential risks and benefits of VBAC and of elective repeat cesarean and will have~     greater clarity about their preferences related to these risks and benefits.~   "
250915|NCT00267722|"~     The purpose of the study is to evaluate an intravenous (by injection) investigational~     medication to treat moderate to severe inflammatory, nonstricturing, nonpenetrating Crohn's~     disease. The research is being conducted at up to 5 clinical research sites in the US and~     Europe and is open to both men and women ages 18 to 70 years old. Participants in the study~     will have a number of visits to a research site up to 17 months. All study-related care and~     medication is provided to qualified participants at no cost: this includes all visits,~     examinations and laboratory work.~      Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the~     immune system to help defend the body from infections and other foreign substances) that is~     directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing~     so, it may prevent them from causing inflammation. Visilizumab has also been observed to have~     a suppressive effect on the body's immune system (system in the body that reacts to foreign~     or occasionally one's own proteins).~   "
250916|NCT00267709|"~     The purpose of the study is to evaluate an intravenous (by injection) investigational~     medication to treat Crohn's disease in patients with at least one perianal fistula. The~     research is being conducted at up to 5 clinical research sites in the US and Europe and is~     open to both men and women ages 18 to 70 years old. Participants in the study will have a~     number of visits to a research site over a 17 month period. All study-related care and~     medication is provided to qualified participants at no cost: this includes all visits,~     examinations and laboratory work.~      Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the~     immune system to help defend the body from infections and other foreign substances) that is~     directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing~     so, it may prevent them from causing inflammation. Visilizumab has also been observed to have~     a suppressive effect on the body's immune system (system in the body that reacts to foreign~     or occasionally one's own proteins).~   "
250917|NCT00267696|"~     The purpose of this study is to test the effectiveness, safety and tolerability of the drug~     combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed~     with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal~     cancer.~   "
250918|NCT00267683|"~     This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety~     of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.~   "
250919|NCT00267670|"~     The purpose of this study is to explore the potential benefit of the medication,~     pentoxifylline, for the treatment of NASH.~   "
250920|NCT00267657|"~     In this parallel group clinical pharmacology laboratory experiment, we will assess~     pharmacodynamic interactions (with a focus on cardiovascular effects) of a 15 mg intravenous~     methamphetamine dose and single oral doses of reserpine (0.5 and 1.0 mg) or placebo.~   "
250921|NCT00267644|"~     Objective: Although approximately 9% of patients presenting to a Pediatric Emergency~     Department (ED) are dehydrated, there is no reliable method to measure objectively the degree~     of intravascular dehydration. Respiratory changes in Inferior Vena Cava (IVC) diameter have~     been shown to predict volume status in adults. Previous research has demonstrated correlation~     between IVC diameter and volume status in children undergoing hemodialysis. Other studies~     have shown that IVC diameter in children can be sonographically measured rapidly and~     accurately by ED physicians. If we can establish that IVC diameter predicts volume status in~     dehydrated children, this tool could assist the ED physician in rapid diagnosis and prompt~     resuscitation without the need to wait for blood or urine tests. In this study we use the~     dehydrated patient as a model for hypovolemia, with the idea that the data could ultimately~     be used in the setting of any hypovolemic state. We aim to evaluate whether ultrasound of the~     pediatric IVC can be used to reliably assess volume status.~      Methods: This is a prospective cohort study. Pediatric ED patients ranging in age from 1 to~     41 months were assessed by a Pediatric emergency physician and stratified as either~     clinically euvolemic or hypovolemic. After consent was obtained, one of three Emergency~     Medicine Residents performed trans-abdominal sonographic measurements of the IVC diameter.~     Measurements of the IVC diameter just caudal to the insertion of the hepatic veins were~     obtained in a longitudinal orientation.~   "
250922|NCT00267631|"~     Objective: Obesity amongst children is a public health issue in the United States and is~     rising at an alarming rate. The purpose of this study is to determine if there is any~     correlation between At Risk body weight (overweight and obese) and immediate health of the~     pediatric population.~      Methodology: As part of routine patient care, we measured length in addition to weight of~     patients 2 years to 18 years of age presenting to the pediatric emergency department. A~     report was run monthly to calculate the BMI of all patients for whom data is available. The~     data were plotted on the year 2000 gender based BMI for age percentile growth charts from~     CDC. A retrospective electronic chart review was conducted for patients At Risk body weight~     (BMI ≥ 85%), and were compared to control or healthy (BMI of 25 - 75 %) group for six~     groups of final ED diagnoses of infectious diseases.~   "
250923|NCT00267618|"~     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the~     effectiveness of the Strongest Families distance intervention compared to usual or standard~     care that is typically provided to children with mild to moderate Recurrent~     Headache/Abdominal Pain symptomology. This is a single-centre trial based at the IWK Health~     Centre. The primary outcome is change in diagnosis.~   "
250924|NCT00267605|"~     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the~     effectiveness of the Strongest Families distance intervention compared to usual or standard~     care that is typically provided to children with mild to moderate Attention~     Deficit/Hyperactivity Disorder. This is a single-centre trial based at the IWK Health Centre.~     The primary outcome is change in diagnosis.~   "
250925|NCT00267592|"~     The purpose of this study is to estimate overall survival for adult patients with newly~     diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with~     concurrent and adjuvant temozolomide. This study will also determine the toxicity and~     toxicity rate of talampanel for this therapeutic regimen.~   "
250926|NCT00267579|"~     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the~     effectiveness of the Strongest Families distance intervention compared to usual or standard~     care that is typically provided to children with mild to moderate Disruptive Behaviour~     symptomology. This is a single-centre trial based at the IWK Health Centre. The primary~     outcome is change in diagnosis.~   "
250927|NCT00267566|"~     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the~     effectiveness of the Strongest Families distance intervention compared to usual or standard~     care that is typically provided to children with mild to moderate Anxiety symptomology. This~     is a single-center trial based at the IWK Health Center. The primary outcome is change in~     diagnosis.~   "
250928|NCT00267553|"~     Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29,~     and will continue to compare combined hormonal therapy using the experimental aromatase~     inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene~     (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the~     treatment of advanced breast cancer. The purpose of this study is to determine whether~     maximal estrogen suppression achieved via the combination of atamestane, plus toremifene~     (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast~     cancer.~   "
250929|NCT00267540|"~     Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone~     mass and bone turnover in young girls aged 12-13.~      More specifically the effects on the following parameters will be assessed:~        -  Vitamin D metabolites.~        -  Parathyroid hormone.~        -  Bone turnover.~        -  Bone mineral accretion.~        -  Serum calcium and phosphate.~        -  Renal handling of calcium and phosphate.~   "
250930|NCT00267527|"~     This is a multicenter, randomized, placebo-controlled, double-blind, Phase 2 study. Patients~     will be treated for a total of 12 weeks. There will be a 6 week follow-up period after the~     treatment period ends. Patients will be randomly assigned to low dose CJC 1295, high dose CJC~     1295 or placebo.~      The objective is to assess and compare the efficacy, pharmacokinetics, safety, and~     tolerability of CJC 1295 in patients with human immunodeficiency virus (HIV) associated~     visceral obesity.~   "
250931|NCT00267514|"~     The purpose of this study is to determine if sevelamer carbonate powder is an effective~     treatment for the control of serum phosphorous levels in patients on dialysis when compared~     to sevelamer hydrochloride tablets.~   "
250932|NCT00267501|"~     The purpose of this study is to elucidate the mechanisms underlying eosinophil growth,~     survival, migration, and function and to investigate and further characterize the~     pathophysiology of, clinical manifestations of, and spectrum of disease severity of~     eosinophilic inflammation in humans.~   "
250933|NCT00267488|"~     The purpose of this study is to find out if Hycamtin given weekly is safe and effective for~     treating your endometrial cancer.~   "
250934|NCT00267475|"~     The purpose of this study is to conduct a translational study in patients with primary~     eosinophil associated gastrointestinal disorders [EGID] (e.g. eosinophilic esophagitis~     eosinophilic gastritis, eosinophilic enteritis [EE], eosinophilic colitis, and eosinophilic~     gastroenteritis [EGE]) with the aim of developing a data bank containing pertinent patient~     demographic information, tissue samples, and DNA, which will facilitate research on the~     pathophysiology of inflammatory disorders and the development of a verified successful~     clinical treatment program.~   "
250935|NCT00267462|"~     The purpose of this study is to identify the patients seen in our practice who are seen with~     Hypertrophic Myopathy diagnosis in order to better understand the presenting characteristics~     of their disease, the diagnostic testing to determine the diagnosis, the methods used to~     follow the disease progression and management practices used in caring for these patients.~     The objectives of this data review will be an analysis to determine if there is a methodology~     that will foster improved diagnostic speed and accuracy, and determine the best management~     practices based on outcomes in these patients.~   "
250936|NCT00267449|"~     The primary study endpoint -SoftScan adjunctive accuracy- will be used to test the hypothesis~     that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic~     accuracy that is significantly better than x-ray mammography alone.~   "
250937|NCT00267436|"~     This project will pilot test a step-by-step guide developed by CDC for organizations to~     engage in evidence-based adaptation of interventions previously shown to be effective in~     research settings for use in real world applications. The second purpose of the program is to~     evaluate the adapted intervention to determine if it is effective in changing behavior of~     HIV+ African American men who have sex with other men.~   "
250938|NCT00267423|"~     Hypothesis 1 (H1): Epicardial biventricular pacing is a safe and feasible method of pacing in~     young patients.~      Over the last two years, physicians at Children’s Healthcare of Atlanta have been implanting~     epicardial BiV pacing systems in children determined to have ventricular dyssynchrony caused~     by numerous cardiac diagnoses. The decision to use these pacing systems was based on the~     knowledge gained by adult studies. Since the use of these pacing systems in the pediatric~     population has not been formally studied, we propose a study to retrospectively review the~     safety and feasibility of epicardial BiV pacing in pediatric patients. This study will~     involve the review of the medical records of children who received epicardial BiV systems at~     Children’s Healthcare of Atlanta between January 2002 and May 2004.~   "
250939|NCT00267410|"~     This project will pilot test a step-by-step guide for community-based organizations to engage~     in evidence-based adaptation of interventions previously shown to be effective in research~     settings for use in real world applications. The main purpose of this program is to improve~     understanding of the processes needed for adapting evidence-based behavioral interventions to~     fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation.~     The second purpose of the program is to increase the number of effective behavioral HIV~     prevention interventions for 18-24 year old sero-positive men of color who have sex with~     other men (MSM of color).~   "
250940|NCT00267397|"~     The purpose of this project is to conduct population based surveillance for prenatally~     diagnosed congenital defects amount residents of the five counties to: improve the~     comprehensiveness of the Metropolitan Atlanta Congenital Defects Program (MACDP) to (1)~     better fulfill its objectives (2) allow assessment of the impact of prenatal diagnosis and~     elective termination on the birth prevalence of congenital defects in Atlanta (3) develop a~     registry of prenatally diagnosed defects to be used in epidemiologic and genetic studies, in~     evaluation prevention programs and in monitoring prenatal diagnostic technology.~   "
250999|NCT00266617|"~     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa in the~     treatment of persistent anemia caused by advanced cancer and aggressive~     adriamycin-chemotherapy. Epoetin alfa is a genetically engineered protein that stimulates red~     blood cell production.~   "
250941|NCT00267384|"~     This randomized, double-blind, placebo-controlled clinical trial will be performed to assess~     the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients~     hospitalized with an infection and treated with aminoglycosides (AGs). Secondary goals of the~     study will be as follows: comparison of the mortality rates, and length of hospitalization~     among patients treated with N-acetylcysteine compared to the control group.~   "
250942|NCT00267371|"~     The purpose of this two arm controlled double-blind study is to determine the safety and~     effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the~     frequency of migraine headaches, in patients who experience migraine headaches and have a~     PFO, compared to medical therapy alone.~   "
250943|NCT00267358|"~     Anorexia and cachexia are devastating complications in late-stage cancer patients and is~     strongly associated with mortality in these patients. Activation of Ghrelin receptors have~     been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity~     and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced~     anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of~     RC-1291 HCl in cancer patients with anorexia and cachexia.~   "
250944|NCT00267345|"~     Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis~     is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the~     chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will~     be measured in the chyle as well as hormonal serum level.~   "
250945|NCT00267332|"~     -  The primary objective of this study is to evaluate the efficacy of modafinil in the~          treatment of opioid induced sedation as measured by the Epworth Sleepiness Scale (ESS).~        -  The secondary objective is to estimate the frequency and severity of toxicity associated~          with Modafinil (400mg) in patients with opioid induced sedation.~   "
250946|NCT00267319|"~     -  The study primarily investigates the effect of copaxone on fatigue during treatment,~          compared to baseline in patients with relapsing-remitting multiple sclerosis.~        -  Secondary outcome measures are:disability, relapse rate, quality of life and depression.~   "
250947|NCT00267306|"~     The purpose of this study is to evaluate the safety and tolerability of visilizumab in~     patients with severe ulcerative colitis that has failed to respond to steroid therapy.~      What is visilizumab?~      Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are~     normally made by the immune system to help defend the body from infections and other foreign~     substances. Visilizumab is thought to selectively affect the immune system to decrease~     inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative~     colitis.~      Who can participate in this study?~      The target population for this study is adults with severe ulcerative colitis that has~     resisted intravenous (IV) steroids. This study is open to patients with the following~     characteristics:~        -  16-70 year olds~        -  A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed~          within 36 months prior to study entry~        -  Active disease despite ongoing treatment with steroids~      How is this study conducted?~      Eligible participants will be administered visilizumab as one daily injection on two~     consecutive days. All medication and study-related care, except for the costs of in-patient~     hospitalization, are provided to qualified participants at no cost. This includes all visits,~     examinations and laboratory work.~      How does one get more information?~      This study is currently enrolling patients at hospitals and clinics in North America and~     Europe. For more information on the study or how to participate in it, please call~     1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.~   "
250948|NCT00267293|"~     Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen~     (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter~     use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to~     determine whether giving both medications together is better than giving one medication alone~     for the treatment of fever.~   "
250949|NCT00267280|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      Cholesterol levels will be measured over six weeks in subjects being treated with two~     different kinds of cholesterol medications to see how the different treatments compare to one~     another.~   "
250950|NCT00267267|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      Cholesterol levels will be measured over six weeks in subjects being treated with two~     different kinds of combination cholesterol medications to see how the different treatments~     compare to one another.~   "
250951|NCT00267254|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      Cholesterol levels will be measured over six weeks in subjects being treated with two~     different kinds of cholesterol medications to see how the different treatments compare to one~     another.~   "
250952|NCT00267241|"~     The aim of this study is to evaluate the effects in terms of gas exchange, respiratory~     mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS~     patients.~   "
250953|NCT00267228|"~     The aim of the study are:~        1. Retrospectively to study the clinical characteristics and features (somatic,~          psychological and social variables) of patients treated in Center for Eating Disorders,~          Odense University Hospital 1994-2004.~        2. To study the predictive power of the psychosocial and morphometric data with regard to~          drop outs, relapse and outcome.~        3. To investigate eating habits, social functions and quality of life in weight recovered~          and chronicly ill patients with eating disorder.~   "
250954|NCT00267215|"~     This trial assessed the safety and efficacy of a single dose of lumiracoxib 400 mg compared~     to placebo and to a single dose of celecoxib 200mg. It also assessed safety and efficacy of~     400mg lumiracoxib administered once a day for 7 days compared to placebo and to 200 mg~     celecoxib twice daily.~   "
250955|NCT00267202|"~     This study is designed to investigate the use of omalizumab as a pretreatment for patients~     with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy~     shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions~     to immunotherapy in patients with persistent allergic asthma.~   "
250956|NCT00267189|"~     The purpose of the study is to assess the effect of everolimus initiation together with~     reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance~     liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.~   "
250959|NCT00267150|"~     Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in~     gastrointestinal (GI) complications in some patients. This study will assess if a switch from~     MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or~     health-related quality of life outcomes and determine the proportion of pancreas-kidney~     transplant recipients who experience any GI complaints under MMF-based immunosuppressive~     treatment.~   "
250960|NCT00267137|"~     Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the~     heart, is the world's most common kind of irregular heart beat. People with AF experience~     symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of~     breath, dizziness, fatigue or weakness. Although AF can occur in otherwise healthy people for~     no apparent reason, it is sometimes associated with high blood pressure, heart disease or~     lung problems. The purpose of the SAFARI trial is to study the effectiveness of pacing~     algorithms in the upper chamber of the heart for patients who have both AF and bradycardia~     (slow heart beat).~   "
250961|NCT00267124|"~     The purpose of this study is to determine the effects of exercise and cardiorespiratory~     fitness on age-related brain changes.~   "
250962|NCT00267111|"~     This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the~     pain response in term neonates subjected to intramuscular injection for administration of~     vitamin K.~      Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in~     decreasing the pain from intramuscular injection in term neonates.~   "
250963|NCT00267098|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. When there are~     changes in the heartbeat, sometimes a pacemaker is used to control the rate and rhythm of the~     heartbeat. In this trial, the researchers will test if pacing both the left and right lower~     half of the heart (ventricles) will:~        -  decrease the number of hospital and clinic visits due to heart failure symptoms~        -  extend life~        -  delay heart failure symptoms as compared to those who are paced in only one ventricle~          (the right ventricle)~   "
250964|NCT00267085|"~     The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid~     Leukemia) vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or~     eliminate all evidence of disease in patients who have CML that is in remission after~     treatment with imatinib mesylate, but who still have small amounts of detectable disease.~   "
250965|NCT00267072|"~     The objectives of this study are:~        -  To identify women at increased risk for developing ovarian cancer~        -  To detect ovarian cancers at an early stage~        -  To investigate the role of tumor membrane fragments as tumor markers for early ovarian~          carcinoma~   "
250966|NCT00267059|"~     The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to~     control CLL in patients who have already received standard therapy. The safety of~     lenalidomide will also be studied.~   "
250967|NCT00267046|"~     Primary:~        1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and~          severity of oral mucositis (OM) in patients with sarcoma receiving multicycle~          chemotherapy.~        2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy.~        3. To evaluate the safety profile of palifermin when combined with multicycle chemotherapy.~      Exploratory:~        1. To evaluate the biologic effect of palifermin on oral mucosa.~        2. To investigate potential biomarker development by biochemical analysis in blood cells,~          serum, and plasma.~        3. To investigate the effects of genetic variation in mucositis genes, drug metabolism~          genes, and drug target genes on patient response to the treatment regimen.~   "
250968|NCT00267033|"~     A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown~     that 8 Gy in a single fraction is very effective in providing pain relief, with complete or~     partial improvement in pain seen in 66% of patients with bone metastases. Percutaneous~     vertebroplasty (PV) is a technique designed to consolidate pathologic vertebral bodies~     through the injection of orthopaedic cement under fluoroscopic guidance. Consolidation~     provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis,~     haemangiomas, myeloma and metastatic diseases, with complete or partial improvement in pain~     seen in 70-85% of patients. To date, no randomized trial has tested the association of~     vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous~     spine metastases.~      A randomized trial has been designed to determine whether vertebroplasty and radiotherapy (8~     Gy in a single fraction) provide enhancement pain and narcotic relief compared to~     radiotherapy alone for patients with painful osseous spine metastases~   "
250969|NCT00267020|"~     The purpose of this research study is to determine the effects and toxicity of gemcitabine~     alone or gemcitabine plus enzastaurin in patients with pancreatic cancer.~   "
250970|NCT00267007|"~     The purpose of this study is to evaluate the neuroprotective effect of PROCRIT (epoetin alfa,~     a glycoprotein that stimulates red blood cell production) versus placebo in patients with~     cancer who develop chemotherapy-induced peripheral neuropathy due to combination Taxane and~     Platinum-Based treatment.~   "
250971|NCT00266994|"~     The TE Registry is a multi-institutional bioinformatics database for the collection of data~     relevant to TE. Participating HTRS affiliated study centers may enroll patients and enter~     data in the TE Registry by completing enrollment and data entry forms and transmitting them~     to the study center. The purpose of this study is to improve our understanding of the~     epidemiology, pathophysiology, and outcome of patients suffering from thromboembolism (TE)~     events.~      The initial objectives of the registry are:~        -  Evaluate the epidemiology and clinical characteristics of known prothrombotic risk~          factors in persons with TE.~        -  Identify the frequency and nature of complications associated with TE and its treatment.~        -  Describe the phenotypes and complications seen in persons with multiple molecular risk~          factors for TE.~        -  Compare the epidemiology, clinical characteristics, and complications seen in patients~          with and without known risk factors for TE.~   "
250972|NCT00266981|"~     The purpose of this study is to compare two techniques for treating patients with Whiplash~     Associated Disorders, in relation to: disability, balance, cervical pain and cervical range~     of motion.~      The hypothesis: The APOS kit treatment is more effective than the short wave therapy.~   "
250973|NCT00266968|"~     Congenital heart disease affects 1 in 100 newborn babies each year and more than 2,000,000~     Americans have a congenital heart defect. One common defect treated at Children's Healthcare~     of Atlanta at Egleston is single ventricle heart. Due to these overwhelming numbers, the use~     of diagnostic imaging technology to assess these defects and heart function is an important~     step in the evolving care of this patient group.~   "
250974|NCT00266955|"~     There is some evidence suggesting ADHD medication interaction could result in mild myocardial~     ischemia/infarct.~   "
250975|NCT00266942|"~     Our aim is a retrospective chart review seeking to determine any differences in the main~     clinical and outcome variables as well as general outcome data such as functional recovery,~     readmission rates, somatic growth and mortality. An n size of 150 to 200 for each of the 2~     groups will give us excellent power to detect potential differences.~   "
250976|NCT00266929|"~     The purpose of this study is to compare the safety and effectiveness of surgical versus~     conservative management of type II odontoid fractures among patients > 64 years of age. Of~     secondary interest is to determine if there are differences in outcomes between anterior~     screw fixation and posterior fusion of these fractures.~   "
250977|NCT00266916|"~     The primary objective of this study is to determine the clinical benefits of percutaneous~     intervention to improve pulmonary blood flow on oxygen saturations, symptoms, exercise~     tolerance and hematocrit in patients with complex cyanotic congenital heart disease who are~     not candidates for surgical repair.~   "
250978|NCT00266903|"~     Review the outcome of treatment with endothelin receptor antagonists (bosentan or sitaxsetan)~     alone or in combination with Sildenafil (a PDE-5 inhibitor) in adult patients with pulmonary~     hypertension due to congenital heart disease.~   "
250979|NCT00266877|"~     The purpose of this study is to learn whether HKI-272 is safe and effective in treating~     non-small cell lung cancer.~   "
250980|NCT00266864|"~     It has long been recognized that co-morbidity associated with multiple metabolic syndrome,~     such as adverse body composition, insulin resistance and autonomic nervous system impairment,~     may lead to significant increase in cardiovascular morbidity and mortality. It is unclear~     whether the co-morbidity evident in this population are due directly to their immobility or~     are the result of unfavorable changes in their underlying hormonal milieu. The purpose of~     this study is to determine the effect of testosterone replacement therapy in hypogonadal~     males on:~      body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy~     expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment~   "
250981|NCT00266851|"~     The purpose of this study is to assess the effectiveness of the azalide macrolide~     azithromycin in adults with persistent asthma.~      Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a~     statistically significant and clinically meaningful improvement in overall asthma symptoms~     and other patient-oriented asthma outcomes one year after initiation of treatment of adult~     primary care patients with asthma?~      Experimental Design: The investigators propose a one-year randomized, placebo-controlled,~     blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of~     azithromycin/placebo as adjunctive therapy (in addition to usual care) in 100 adult asthma~     patients recruited from practice-based research networks (e.g., Wisconsin Research and~     Education Network (WREN) and others). This practical clinical trial will (1) enroll a~     representative sample of asthma patients encountered in the practices of primary care~     physicians, (2) employ standard clinical trial methodology to ensure internally valid results~     and (3) measure outcomes important to patients, so that the results will be valid and~     applicable to the kinds of asthma patients encountered by family physicians and other primary~     care providers.~      Active study sites - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee,~     Madison, Mauston, Rice Lake, Tomah, Wausau; Colorado: Monument; Illinois: Peoria; Nevada:~     Reno; North Carolina: Granite Falls; North Dakota: Minot; Ohio: Cleveland, Berea; Oklahoma:~     Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford; Rhode Island:~     East Providence~   "
250982|NCT00266838|"~     The antineoplastic agent Docetaxel (Taxotere®) is approved for the treatment of patients with~     metastatic and locally advanced breast cancer and other malignancies. There are 2 frequently~     used schedules of treatment with Docetaxel. Docetaxel can be administered every 3 weeks or in~     a weekly regimen. The efficacy seems to be similar but the toxicity profile changes. In the~     standard 3-weekly Docetaxel regimen the dose-limiting side effect is myelosuppression, while~     in the weekly regimen there is only a mild myelosuppression. On the other hand, weekly~     Docetaxel has a side effect that is rare in the 3-weekly schedule: epiphora (= tearing eye)~     caused by dacryostenosis.~      The underlying mechanism of dacryostenosis induced by weekly Docetaxel is fibrosis of the~     lacrimal puncta and canaliculi. Docetaxel has been reported to be secreted in the lacrimal~     tears. Direct contact between Docetaxel containing tears and the epithelial lining causes~     chronic inflammation of the mucosa and ultimately fibrosis of the most narrow part of the~     lacrimal outflow system i.e. the lacrimal puncta and canaliculi.~      A surgical treatment is possible for dacryostenosis. In case of subtotal stenosis of the~     lacrimal canaliculi, silicone intubation of the canaliculi is performed in order to prevent~     further closure. In the case of complete stenosis, placement of a permanent pyrex glass tube~     of Jones is required.~      To our knowledge, there is no primary prevention for Docetaxel induced dacryostenosis.~      The rationale of this randomized double blind interventional study is to investigate the~     efficacy of corticosteroid versus artificial tears topical eye treatment in patients on a~     weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel in~     the lacrimal tears will be washed away by the repetitive use of eye drops. In addition, eye~     drops containing corticosteroids have an anti-inflammatory effect and may further prevent the~     formation of fibrosis.~      A new treatment protocol will be investigated. Two different commercially available eye drops~     will be compared: dexamethasone sodium phosphate (Maxidex®, Alcon) in one eye of the patient~     and artificial tears (Lacrystat®, Viatris) in the other eye of the same patient. The study~     period will start with topical eye treatment from day 1 of cycle 1 and will continue during~     the administration of chemotherapy, with a final analysis at 26 weeks.~   "
250983|NCT00266825|"~     The purpose of the study is to determine if increasing DHA intake during pregnancy can~     increase gestation duration and enhance infant and childhood outcomes related to visual~     acuity, stereoacuity, attention, and distractibility.~   "
250984|NCT00266812|"~     This is a phase II, randomized, multicenter, open-label study designed to assess the safety~     and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain~     radiation and later on at 14 days on/14 days off schedule in patients with cerebral~     metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be~     evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2~     months. Progression-free survival at 6 months, duration of overall survival, and quality of~     life will also be evaluated.~   "
251000|NCT00266604|"~     The purpose of this study is to identify patient characteristics (such as baseline seizure~     frequency) that may predict effective doses of topiramate using just that one drug~     (monotherapy) as initial therapy for epilepsy. Topiramate is an anti-epileptic drug that is~     approved for the treatment of epilepsy in adults and children 2 years of age and above.~   "
250985|NCT00266799|"~     This is an open-label, multinational, randomized, multicenter trial designed to compare~     pegylated liposomal doxorubicin with capecitabine as first line chemotherapy of metastatic~     breast cancer. The primary objective of the study is to compare the time to disease~     progression, although overall response rates, overall survival, quality of life, time to~     treatment failure, and safety and tolerability will also be assessed.~   "
250986|NCT00266786|"~     Ketorolac has been marketed for several years in other forms (tablet and injectable) for the~     short-term relief of pain. This study will test whether a new dosage form (nasal spray)~     containing ketorolac is effective at relieving the pain of major abdominal surgery, and will~     also assess product safety. Previous studies with the nasal spray have suggested that it is~     similar to the previously approved injectable form in effectiveness for pain relief and in~     its safety profile.~      Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when~     the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first~     dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to~     4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug,~     subjects will be given morphine sulfate or other standard analgesics. Follow-up safety~     evaluations will occur about 1 and 2 weeks after the start of dosing.~      Subjects will be asked to answer questions about their pain relief and any possible side~     effects of the drug during the study, and will be given physical examinations, including~     nasal evaluations, before and during the clinical trial. A small amount of blood will be~     drawn for routine clinical laboratory testing.~   "
250987|NCT00266773|"~     The purpose of this study is to determine whether a telephone-based self-monitoring and~     skills review program with personalized therapist feedback following group CST for chronic~     pain can reduce and prevent relapse of the pain, physical disability, and psychological~     distress experienced by patients with chronic pain of the muscles and bone.~   "
250988|NCT00266760|"~     Episodic ataxia (EA) is a rare genetic disease characterized by episodes of imbalance,~     incoordination, and slurring of speech. The underlying cause of EA is only partly understood,~     and currently there are no established treatments. There is also little information about the~     link between EA's clinical features and its genetic basis. The purpose of this study is to~     better characterize EA and disease progression. In turn, this may direct the development of~     future treatments.~   "
250989|NCT00266747|"~     The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with~     Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg~     dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The~     secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of~     life in patients with GAD and to evaluate safety of SR58611A.~   "
250990|NCT00266734|"~     To compare the efficacy of a recently FDA approved point of care diagnostic test, the RPS~     Adeno Detector (Rapid Pathogen Screening, Inc.; South Williamsport, PA), against cell culture~     for detecting adenoviral conjunctivitis~   "
250991|NCT00266721|"~     The hypothesis of this study is that the administration of pancrelipase with meals will~     benefit symptoms of post-prandial bloating, pain and eructation.~   "
250992|NCT00266708|"~     Patients with kidney failure have underlying bone disease at the time of transplant.~     Fractures of various bones can be as high as 22%. Medication required for the transplant~     plays a role in bone loss.~      Bisphosphonates are used in the general population to treat bone loss of osteoporosis and~     steroid-induced bone loss. While previous studies, using various bisphosphonates, have shown~     preservation of bone mineral density in renal transplant recipients, we have demonstrated~     that pamidronate, a second generation bisphosphonate, is associated with low bone turnover~     while still preserving bone mineral density. Improved bone mineral density is associated with~     decreased fracture risk in the general population, while low bone turnover may be associated~     with increased fracture in dialysis patients.~      The purpose of this study is to determine whether risedronate, a third generation~     bisphosphonate, is effective in preserving bone density when given prophylactically following~     renal transplantation and whether it is associated with low bone turnover at one year~     following renal transplantation.~   "
250993|NCT00266695|"~     To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study~     (NCT00604383), and who are felt by the investigator to have the potential to benefit from the~     ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion~     of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine~     the long-term safety and effect of ruboxistaurin on vision.~   "
250994|NCT00266682|"~     People who have a slow heart beat, or whose heart does not beat on its own, may be in need of~     an electronic device called a pacemaker. A pacemaker is implanted surgically just under the~     skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending~     electrical signals (pacing) directly to the heart tissue through flexible wires called leads.~     The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe~     and effective for both sensing the heart’s natural rhythm and pacing the heart when it does~     not beat on its own. This lead will be studied in both the right atrium and right ventricle.~     A previously market approved Medtronic lead model will serve as a comparison to prove the~     safety and effectiveness of the SelectSecure Model.~   "
250995|NCT00266669|"~     The purpose of this study is to investigate the efficacy and safety of a topical gel~     formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate~     to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to~     autoimmune diseases, such as scleroderma.~   "
250996|NCT00266656|"~     This is an extension study that will gather long-term data on the effect of early growth~     hormone (GH) treatment on adult height and other aspects of health and development in girls~     with Turner syndrome. The main purpose is to determine whether girls who received 2 years of~     GH treatment before 6 years of age achieve taller adult height than girls who were untreated~     during this time. The study will also look at middle ear and hearing function, and cognitive~     and behavioral development. Protocol completion is defined as attainment of height velocity~     less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.~   "
250997|NCT00266643|"~     This study is to compare the tolerability of different methods for switching from another~     medication to duloxetine for the management of diabetic nerve pain. The primary objective is~     to compare the most gradual method with the most abrupt method, to see if they have different~     tolerability.~   "
251004|NCT00266552|"~     The purpose of the study is to assess the effectiveness and safety of an oral solution of~     risperidone (an antipsychotic medication) versus placebo in the treatment of conduct disorder~     in children with mild, moderate, or borderline mental retardation.~   "
251005|NCT00266539|"~     The purpose of this study is to compare two pain medications delivered by two different forms~     of patient-controlled pain management systems: the Fentanyl HCl Patient-Controlled~     Transdermal System (E-TRANS fentanyl) and the morphine intravenous pump. Fentanyl HCl and~     morphine are narcotic pain relievers. The E-TRANS fentanyl system is a small unit worn on the~     patient's upper outer arm or chest that uses low-intensity electrical current to deliver~     fentanyl through the skin and into the patient's bloodstream. The patients studied will be~     those who have just had scheduled abdominal or pelvic surgery.~   "
251006|NCT00266526|"~     Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV~   "
251007|NCT00266513|"~     This study investigates gene abnormalities in Primary Immune Deficiency(PID) with a goal of~     improving the diagnosis and treatment of patients.~      The specific disorders include:~        1. X linked hyper IgM Syndrome which is caused by an abnormality in the CD40L gene.~        2. NEMO associated immune deficiency which is caused by an abnormality in a gene called~          NEMO.~        3. Common variable immunodeficiency (CVID) which has an unknown genetic basis.~        4. Other disorders of immunoglobulin production.~      This study will:~        1. Better characterize the clinical features of CD40 L deficiency and NEMO associated~          immune deficiency and other related primary immune deficiency syndromes.~        2. Determine the frequency of CD40 L and Nemo abnormalities.~        3. Determine whether particular abnormalities in these genes are associated with more of~          less severe illness or with specific symptoms.~        4. Explore the basic mechanism by which these altered genes cause immune dysfunction.~        5. Identify other genes causing low immune globulin levels and related primary immune~          deficient states.~   "
251008|NCT00266500|"~     This study will investigate how different parts of the body lose body heat and will measure~     the heat released by specific areas such as the limbs and abdomen. Animal studies suggest~     that dissipation of body heat may affect energy expenditure, and therefore, body weight. This~     study will explore the relationship between obesity and heat in humans.~      Healthy people 18 years of age and older who are of normal weight or who are obese and who~     are not taking medications for obesity-related medical conditions may be eligible for this~     study. Candidates must have a body mass index (BMI) between 18 and 25 kg/m2 for normal weight~     subjects or a BMI greater than 30 kg/m2 for obese subjects. All candidates must weigh less~     than 300 pounds. Women must have a normal menstrual cycle or be postmenopausal.~      Participants undergo the following procedures in a single day on an outpatient basis:~        -  Medical history, physical examination, blood and urine tests and electrocardiogram.~        -  DEXA and MRI scans of the trunk and limbs to measure the amounts of muscle, bone and fat~          in the body. For the DEXA scan, the subject lies on a table while a very small dose of~          x-rays is passed through the body. For the MRI, the subject lies on a table that is~          moved into a steel cylinder. A magnetic field and radio waves produce images that are~          used to measure fat in the trunk of the body, thighs, and arms.~        -  Infrared photography of hands, front of thigh, and abdomen. A special camera is used to~          measure the heat leaving the body.~        -  Bicycle exercise test. The subject exercises on a stationary bicycle while the heart~          rate, heart rhythm, blood pressure and oxygen consumption are measured. The pedal~          resistance is increased gradually until the subject can no longer exercise and then the~          resistance is gradually decreased for cool-down.~      Participants who qualify for the second part of the study undergo the following procedures~     during a 5-day in-hospital stay:~        -  Temperature measurements. Body temperature is measured in the ear canal. Skin~          temperature is measured with small round adhesive temperature-sensing patches placed on~          the abdomen and limbs for up to 5 days.~        -  Measurement of body radiowaves. A remote sensing device is used to measure microwaves~          that are naturally released from the body.~        -  Infrared photography of hands, front of thigh and abdomen is done several times during~          the study.~        -  Application of mild coolness to hands, thigh and abdomen. The subject's hand is exposed~          to mild coolness first by immersion in cool water, then by a cool-water spray, then by a~          cooled pad placed on the hand, and finally, with a device applied to the hand that cools~          and has a gentle vacuum. The abdomen and thigh are similarly exposed. During each test,~          an infrared camera records how heat is released by the body.~        -  Temperature effects of a meal. The subject drinks lemon-flavored sugar water to~          measure the body's response.~        -  Bicycle exercise test. The subject exercises on three different occasions. During or~          after some of the tests, mild cooling is applied to the abdomen, front of the thigh, or~          hands.~        -  Measurement of exhaled air (indirect calorimetry). The subject wears a hood that~          collects and analyzes exhaled air for 15- to 30-minute periods.~        -  Photography and videotaping. The subject is photographed and videotaped. The images do~          not include views of any private parts, and the subject's identity is protected.~   "
251009|NCT00266487|"~     The purpose of this study is to examine whether the lowering of blood homocysteine levels by~     treatment with B vitamins can prevent cardiovascular disease~   "
251010|NCT00266474|"~     Aim of the study is to detect the prevalence of chronic rhinosinusitis and the colonisation~     with Pseudomonas aerug. in the upper airways in patients with cystic fibrosis.~   "
251011|NCT00266461|"~     Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, commonly~     occurs in patients who have undergone abdominal surgery and contributes to postoperative~     morbidity, including delayed enteral nutrition, increased patient discomfort, and prolonged~     hospitalization. POI appears to be have many causes, with activation of inhibitory reflexes,~     inflammatory responses, and the effects of anesthesia and analgesics all playing roles.~     However, there is no approved pharmacological therapy for the treatment and prevention of~     POI.~      Daikenchuto (TU-100) is an herbal formulation consisting of Asian ginseng, Zanthoxylum fruit~     (Sichuan pepper), ginger, and malt sugar, which was originally described in Jin kui yao lue,~     the classical medical textbook written in ancient China in the third century by Zhang Zhong~     Jing. Since it was introduced to Japan, Daikenchuto has been used in the treatment of~     abdominal pain and a feeling of coldness in the abdomen.~      TSUMURA Daikenchuto Extract Granules, Product Code TU-100, is a modern herbal product~     manufactured in the dosage form of granules by Tsumura & Co. The current Tsumura product,~     TU-100, was approved for manufacture as a prescription drug in 1986 by the Japanese Ministry~     of Health and Welfare and has been sold commercially as a prescription Kampo (a generic term~     for the system of traditional medicine that was developed in Japan after being introduced~     from China in the fourth century) drug in Japan for many years. The drug product proposed for~     use in the clinical studies is identical to the drug currently sold in Japan. In addition,~     all three botanical components and maltose syrup powder are considered as food substances and~     are currently part of the United States food supply.~      The purpose of this study evaluate the tolerability, efficacy and safety of TU-100 for the~     treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel~     resection~   "
251012|NCT00266448|"~     The purpose of this study is to determine whether whole body washing with chlorhexidine in~     combination with mupirocine nasal ointment is effective in the eradication of~     meticillin-resistant Staphylococcus aureus (MRSA).~   "
251013|NCT00266435|"~     The main objective of this study is to compare the sensitivity and specificity of a new~     system for analyzing the electrocardiogram (ECG) to the sensitivity and specificity of a~     conservative treadmill test in asymptomatic subjects, classified by Framingham score as~     moderate to high risk. Subjects will perform a routine exercise test with the addition of~     another set of electrodes to record high resolution ECG. All subjects will perform a stress~     echocardiography. The result of the routine ECG analysis will be compared to the new system~     and to the echocardiography results.~   "
251014|NCT00266422|"~     Comparison of short and long term neurological outcome of VLBW infants with and without early~     onset hypotension required intervention. The cohort includes all VLBW infants born in our~     institution between January 1997 and December 2000.~   "
251015|NCT00266409|"~     An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in~     symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective~     Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI)~     to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at~     least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder.~     Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI~     alone during the study. Most symptom evaluations will be done using an automated phone~     interview system. There are 4 clinic visits.~   "
251016|NCT00266396|"~     Despite the widespread use of total hip and knee arthroplasty, there is a notable lack of~     consensus regarding postoperative treatment, mostly because of the lack of well-designed~     studies testing the efficacy and effectiveness of such practices. In particular, there are no~     evidence-based recommendations on the amount of weight that the patient should be advised to~     bear on the operated leg after the operation.~   "
251017|NCT00266383|"~     The human homologue of mice natural-resistance-associated macrophage protein 1 (Nramp 1)~     gene, NRAMP 1, has been reported to play a role in the susceptibility to tuberculosis in~     humans. The aboriginal population in Taiwan has a 5-fold higher prevalence of tuberculosis~     than the Han Chinese. Whether genetic factors such as NRAMP 1 polymorphisms play a role in~     the prevalence of tuberculosis in Taiwanese aboriginals should be clarified.~   "
251103|NCT00265239|"~     Early reperfusion therapy has improved the clinical outcomes of patients with acute~     myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion~     injuries. There is now increasing evidence that reactive oxygen species cause reperfusion~     injury. This study was designed to examine the effects of edaravone, a novel free radical~     scavenger, in patients with AMI.~   "
251018|NCT00266370|"~     1. To establish a pathology reference laboratory for the consultation on the diagnosis of~          infectious diseases and lymphoma.~        2. To study the specific pathogens on 100 cases of unexplained death due to infectious~          diseases in the files of Taiwan CDC and the Forensic Institutes of Department of Law and~          Justice.~        3. To study the distribution of children lymphoid lesions in Vietnam and Taiwan and their~          virus association.~        4. To establish a tissue bank for infectious diseases and lymphoma.~   "
251019|NCT00266357|"~     A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.~   "
251020|NCT00266344|"~     A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.~   "
251021|NCT00266331|"~     This study is for the patient with breast cancer. To take part in this study, external beam~     radiation therapy needs to be part of the treatment plan. Reduced glutathione, an ingredient~     of RayGel™, has been helpful in decreasing some radiation therapy side effects to the skin.~      Reduced glutathione plays a vital role in both making DNA and cell repair. This study will~     measure if RayGel decreases skin reaction in breast cancer patients treated with external~     beam radiation therapy.~   "
251022|NCT00266318|"~     The main purpose of this study is to evaluate the safety and tolerability of combination~     therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin~     (based on body weight) for 48 weeks in HCV genotype 1 infected subjects, who are~     non-responders to previous pegylated interferon alfa plus ribavirin therapy.~      This is an open-label, multicenter study. All subjects will receive Infergen 24 mcg~     administered by injection daily plus ribavirin 800-1400 mg (based on body weight)~     administered by mouth daily for 48 weeks~      * If any 5 of the first 10 subjects can not tolerate the 24 mcg daily dosage of Infergen by~     week 4, as determined by the principal investigator, then the dosage of Infergen will be~     changed to 15 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body~     weight) administered by mouth daily for 48 weeks~   "
251023|NCT00266305|"~     The main purpose of the study was to examine whether fish oil supplementation of lactating~     mothers affect infant development during first year of life, focusing on visual and mental~     development. A follow-up studies are conducted in order to see if early intake of long-chain~     n-3 polyunsaturated fatty acids (n-3 LCPUFA) have any long-term effects on health, primarily~     immun function and markers of cardiovascular risk.~   "
251024|NCT00266292|"~     The purpose of this study is to investigate the effects of long-chain n-3 polyunsaturated~     fatty acids (n-3 LCPUFA) on immune function and cardiovascular disease risk~   "
251025|NCT00266279|"~     This phase II study will test the response rate of combined oxaliplatin and capecitabine~     treatment when administered at a given dose and schedule, in patients with Head and Neck~     cancer for which there is no curative treatment.~   "
251026|NCT00266266|"~     HPV DNA testing by a clinician has been shown to be highly sensitive in detecting cervical~     disease. Can we prove that HPV self-testing will be sufficiently sensitive to detect disease~     in high risk population who for various reasons would not have routine pap smear screening?~   "
251027|NCT00266253|"~     This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK~     Activator (2) in combination with metformin, compared to that of placebo (metformin~     monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their~     stable dose of metformin and will be randomized to receive either GK Activator (2) or~     placebo. The anticipated time on study treatment is less than 3 months, and the target sample~     size is 100-500 individuals.~   "
251028|NCT00266240|"~     This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK~     Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The~     anticipated time on study treatment is less than 3 months, and the target sample size is~     100-500 individuals.~   "
251029|NCT00266227|"~     This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study~     evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid~     arthritis (RA) who are receiving Methotrexate (MTX).~   "
251030|NCT00266214|"~     The purpose of this study is to evaluate the analgesic efficacy and safety of the lidocaine~     patch 5% compared to placebo in patients with moderate to severe pain associated with carpal~     tunnel syndrome.~   "
251031|NCT00266201|"~     Usually, heart failure refers to myocardial insufficiency of the left ventricle. However,~     in patients with congenital heart defects, often predominantly the right ventricle is~     affected.~      Brain natriuretic peptide (BNP) has been shown to be a reliable biomarker for left~     ventricular function and severity of left ventricular failure.~      The objective of the present investigation is to evaluate brain natriuretic peptide (BNP)~     with regard to its predictive value as a biomarker for right ventricular function, clinical~     symptoms and/or the patients' quality of life.To this end, blood levels of neurohumoral~     markers are measured and tested for statistical correlation with exercise tolerance and right~     ventricular function, as assessed by imaging methods. A sample of healthy volunteers serves~     as a control group.~   "
251032|NCT00266188|"~     Tetralogy of Fallot is the most frequent complex congenital heart malformation. Over the past~     five decades, surgical repair has been performed with respectable results. However, relevant~     postoperative residues frequently remain. Pulmonary insufficiency, in particular, has been~     identified as a factor limiting the right ventricular function and, accordingly, the quality~     of life and life expectancy.~      With increasing use of cardiac MRI for both measurement of ventricular function and imaging~     of pulmonary arteries, residual defects have been discovered that were not detectable by~     echocardiography. There is mounting evidence of right ventricular pressure and volume stress~     in Fallot patients after surgical correction. At present, it is impossible to detect right~     ventricular insufficiency at an early stage. Hence, it is to be assumed that right~     ventricular insufficiency is underdiagnosed and therapeutic action frequently is initiated~     beyond the point of no return of ventricular function.~      The objective of this study is the systematic collection of cross-sectional and longitudinal~     data from extensive standardised examinations, including MRI, echocardiography, pulmonary~     function and ergometry tests, ECG and quality of life assessments, in a large number of~     patients with surgically corrected tetralogy of Fallot, and the setup of a database. The data~     obtained are supposed to provide information on the long-term outcome of surgical correction,~     to help establish criteria for necessity and time of re-intervention or re-operation, and to~     assess the effectiveness of re-interventions and re-operations.~   "
251033|NCT00266175|"~     Postoperative stenoses of the pulmonary artery vascular system seldom occur alone; they are~     frequently found in connection with congenital heart defects or malformation syndromes. The~     resulting increase of afterload represents a serious pressure load for the right ventricle.~     Depending on the number and severity of the stenoses, gradual functional right ventricular~     failure is to be expected. Due to limited clinical experience, there has not yet been a~     consensus concerning the indications for the different therapeutic strategies (balloon~     dilatation, stent implantation, surgical dilatation techniques). Up to now, only few~     investigators in few centres use stents as therapy. Therefore, systematic multicenter~     investigations assessing larger groups of patients undergoing this procedure are not yet~     available. The same applies to other novel dilatation techniques, such as the use of the~     cutting balloon as therapy for rigid valve stenoses.~      By comparing and analysing different invasive forms of treatment (balloon dilatation, stent~     implantation and surgery), we expect to achieve an optimisation of therapy.~      In the study, the outcomes of different strategies as practiced now in German cardiological~     centers will be compared and the main factors influencing the results will be determined. On~     the basis of a standardized investigation before and one year after the intervention, these~     comparisons with respect to the reduction of stenosis and corresponding changes of right~     ventricular functional and anatomical changes are carried out correcting for known~     confounders. The assessment of the different included invasive and non-invasive diagnostical~     procedures with respect to their ability to detect pathological findings and their changes as~     result of the treatment is an important secondary target of the study.~   "
251034|NCT00266162|"~     Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that~     constitutes a great burden at the individual as well as the familial and social level. The~     combination of critically increased pulmonary vascular resistance, progressive pressure load~     of the right ventricle and disturbance of pulmonary gas exchange result in long-term~     polymorbidity. The objective of this study is to look into the effects of medium-term~     pulmonary pressure-lowering treatment with oral bosentan in patients with congenital heart~     defects and clinically relevant pulmonary arterial hypertension (PAH), taking advantage of~     extensive diagnostic procedures.~   "
251035|NCT00266149|"~     The present study evaluates the effect of oral contraceptives on lamotrigine plasma~     concentrations in a double blind, placebo controlled, cross-over study in patients with~     epilepsy.~   "
251036|NCT00266136|"~     The study in patients with primary and secondary AML and high-risk MDS uses a~     risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of~     G-CSF priming, and of autologous stem cell transplantation.~   "
251037|NCT00266123|"~     To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL +~     MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to~     renal allograft function at month 12 post-transplantation.~   "
251038|NCT00266110|"~     RATIONALE: Vaccines made from a person's white blood cells may help the body build an~     effective immune response to kill tumor cells. Monoclonal antibodies, such as trastuzumab,~     can block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine~     therapy together with trastuzumab and vinorelbine may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with~     trastuzumab and vinorelbine works in treating patients with locally recurrent or metastatic~     breast cancer.~   "
251039|NCT00266097|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and gemcitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     oxaliplatin together with gemcitabine, erlotinib, and radiation therapy may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin,~     gemcitabine, and erlotinib when given together with radiation therapy in treating patients~     with unresectable and/or metastatic pancreatic cancer or biliary tract cancer.~   "
251040|NCT00266084|"~     This study tested the safety and performance of a new cell collector device and compared the~     results to those obtained with the current existing device that are being used routinely~   "
251041|NCT00266071|"~     Pressure ulcers are a common and frustrating problem and their treatment is critical in~     elderly people. The interaction between external pressure and the skin vascular is central to~     the prevention of pressure ulcers. It is only through understanding of the physiology of~     cutaneous perfusion and its relation to external pressure or different stimuli that effective~     preventive measures to reduce skin beakdown can be adapted in clinical practice.~   "
251042|NCT00266058|"~     The purpose of this study is to find out whether taking certain anti-HIV medicines with~     certain antimalarial medicines affects the amount of the medicines in the blood.~      The study medicines that will be used are artemether/lumefantrine (antimalarial medication)~     and lopinavir/ritonavir or efavirenz (anti-HIV medications). Artemether/lumefantrine is not~     approved by the United States Food and Drug Administration (FDA) but is recommended as~     standard of care medical treatment for malaria in Africa and Asia. Lopinavir/ritonavir and~     efavirenz are approved by the FDA. Artemether/lumefantrine and lopinavir/ritonavir or~     efavirenz may need to be used together to treat children in Africa and Asia. We seek to learn~     about whether or not the use of these medicines together results in a change in blood levels~     of any of these medicines. The information obtained from this study will help doctors to~     provide a better treatment to children and adults with malaria and HIV.~   "
251052|NCT00265928|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Giving bortezomib~     together with rituximab may be an effective treatment for non-Hodgkin's lymphoma.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab~     works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma,~     including Waldenstrom's macroglobulinemia.~   "
251043|NCT00266045|"~     The results of the Prolong study, currently submitted for publication, show that patients~     with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured~     one month after anticoagulation with vitamin K antagonists is stopped, have a high rate of~     recurrences (about 14%) and a prolongation of anticoagulation is effective in reducing~     significantly this rate. Those patients with normal D-dimer (about 60% of all patients~     examined) have a low rate of recurrences (about 5%) and likely a prolongation of~     anticoagulation in all these patients cannot be recommended.~      In line with these results, the Prolong-Two study aims at assessing the predictive role for~     recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its~     withdrawal and c) periodically during follow up.~      Patients with a first unprovoked venous thromboembolism (including proximal deep vein~     thrombosis of a leg and/or pulmonary embolism) which are treated with vitamin K antagonists~     for not less than 6 months are considered for the study. D-dimer assay is performed during~     anticoagulation and patients with altered results continue the anticoagulation for 6 more~     months. Those with normal D-dimer stop the anticoagulant treatment and are again examined one~     month later. Anticoagulation is resumed for 6 more months in those patients with abnormal~     D-dimer results but is permanently stopped in those with a normal assay. The latter patients~     are examined and D-dimer assay performed again every two months to evaluate the natural~     history of the assay after anticoagulation is stopped and the possible predictive value for~     recurrence of a change of the assay during follow-up from normal to abnormal results.~   "
251044|NCT00266032|"~     The purpose of the study is to determine safety and efficacy of long-cycle regimens of an~     oral contraceptive.~   "
251045|NCT00266019|"~     Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The~     cause of NASH is not completely understood and currently there is no effective treatment for~     this disease. An effective approach to treatment is needed since without treatment this~     disease may progress to fibrosis and cirrhosis. Obesity is one of the most important risk~     factors for NASH and weight reduction is generally recommended as an initial step in its~     management. However, there are very limited data on the efficacy of weight reduction as a~     treatment for NASH. Data from uncontrolled trials using poorly defined primary outcome~     measures and patient populations and nonstandardized weight loss interventions suggest that~     modest weight loss may improve fatty liver disease. The objective of this project is to~     conduct a randomized controlled trial of weight reduction in the management of NASH using a~     combination of diet, exercise, and behavior modification.~   "
251046|NCT00266006|"~     This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and~     preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute~     intracerebral haemorrhage.~   "
251047|NCT00265993|"~     Study objectives :~        -  To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute~          venous thromboembolic disease.~   "
251048|NCT00265980|"~     Previous work in our laboratory, and many others, has shown that body weight is regulated.~     When anyone, fat or thin, tries to maintain a reduced body weight, many systems affecting~     energy balance (skeletal muscle, neuroendocrine, and autonomic systems) conspire to slow~     metabolic rate thus favoring the regain of lost weight. Individuals with leptin deficiency~     are remarkably similar to weight-reduced individuals. Their metabolism, thyroid hormones, and~     sympathetic nervous system activity are all low despite their obesity. While administration~     of leptin to leptin-deficient humans results in substantial weight loss and increases in~     energy expenditure. However, leptin administration to leptin-sufficient humans at usual body~     weight has little or no effect on weight unless given in doses 10-20 times what would be~     considered to be in the normal physiological range. This study examines the hypothesis that~     leptin is read by various systems regulating energy balance as an indicator of how much~     energy we have stored and that the body perceives the weight-reduced state as a condition of~     relative leptin insufficiency. Within this model, restoration of leptin to levels present~     prior to weight loss should relieve much of the metabolic opposition to keeping weight off.~     Preliminary studies support this hypothesis.~      Healthy lean and overweight subjects are admiited to the General Clinical Research Center at~     Columbia University Medical College and placed on a liquid formula diet. Calories are~     adjusted until weight is stable and then subjects undergo testing of neuroendocrine,~     autonomic, and metabolic function. All subjects undergo an in-patient 10% weight reduction.~     Subjects are studied in a single blind placebo control design in which they are studied at~     usual weight and while maintaining a 10% reduced weight. At either usual weight or reduced~     state subjects undergo a single blind crossover placebo/control study in which they receive~     placebo,lepin injections while on an isocaloric diet either at usual weight or following a~     10% weight loss. Leptin injections are given in doses that restored 8AM circulating leptin~     concentrations to those present at initial body weight.~   "
251049|NCT00265967|"~     Study objectives:~        -  To demonstrate the effect of irbesartan on the regulation of diastolic blood pressure,~          in case of missing one dose after a period of administration for 6 to 8 weeks~        -  To evaluate the safety of irbesartan~   "
251050|NCT00265954|"~     High quality behavioral weight loss programs are not widely accessible. The Internet offers~     one way to deliver health behavior programs to a wider audience. However, effective weight~     loss treatments are intensive and program delivery over the Internet may not be capable of~     duplicating the level of engagement typically generated during traditional in-person~     treatment. The goal of this study is to test the effectiveness of three weight loss~     interventions: Internet alone, Internet+periodic in-person support, and in-person alone. The~     investigators hypothesize that the in-person and internet+in-person interventions will~     produce better weight loss and maintenance than the internet only group.~   "
251051|NCT00265941|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor~     cells more sensitive to radiation therapy. Monoclonal antibodies, such as cetuximab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It~     is not yet known whether radiation therapy and cisplatin are more effective with or without~     cetuximab in treating head and neck cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and~     cetuximab to see how well they work compared to radiation therapy and cisplatin in treating~     patients with stage III or stage IV head and neck cancer.~   "
251079|NCT00265551|"~     The purpose of this study is to determine whether a low dose and a high dose of the study~     drug SCA-136 are effective and safe in the treatment of schizophrenia requiring~     hospitalization.~   "
251125|NCT00264953|"~     This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD~     as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the~     optimum radiation dose comparing of 30 to 20 Gy in the same context.~   "
251053|NCT00265915|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such~     as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood.~     Giving rituximab together with GM-CSF may be an effective treatment for chronic lymphocytic~     leukemia.~      PURPOSE: This phase II trial is studying how well giving rituximab together with GM-CSF works~     in treating patients with B-cell chronic lymphocytic leukemia.~   "
251054|NCT00265902|"~     RATIONALE: Diagnostic procedures, such as infrared thermography, may help find Kaposi's~     sarcoma and learn the extent of disease.~      PURPOSE: This clinical trial is studying how well infrared thermography finds skin lesions in~     patients with Kaposi's sarcoma.~   "
251055|NCT00265889|"~     RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an~     effective treatment for Hodgkin's lymphoma.~      PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants~     works in treating patients with progressive or recurrent Hodgkin's lymphoma.~   "
251056|NCT00265876|"~     RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving AZD0530 together with gemcitabine may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of AZD0530 when~     given together with gemcitabine and to see how well they work in treating patients with~     locally advanced or metastatic pancreatic cancer that cannot be removed by surgery.~   "
251057|NCT00265863|"~     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above~     normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin,~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well mitomycin works when given as a~     hyperthermic peritoneal perfusion in treating patients with malignant ascites.~   "
251058|NCT00265850|"~     PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given~     together with combination chemotherapy to compare how well they work in treating patients~     with metastatic colorectal cancer.~      RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving monoclonal antibodies together with combination~     chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy~     is more effective with cetuximab and/or bevacizumab in treating patients with colorectal~     cancer.~   "
251059|NCT00265837|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow~     transplant or peripheral blood stem cell transplant helps stop the growth of cancer and~     abnormal cells and helps stop the patient's immune system from rejecting the donor's stem~     cells. When certain stem cells from a donor are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells. Removing the T cells from the donor cells before transplant may stop this from~     happening.~      PURPOSE: This randomized phase III trial is studying donor bone marrow that is treated in the~     laboratory using two different devices to compare how well they work in treating patients who~     are undergoing a donor bone marrow transplant for hematologic cancer.~   "
251060|NCT00265824|"~     PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab~     alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work~     compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy~     combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer~     that cannot be removed by surgery.~   "
251061|NCT00265811|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor~     cells and keep colon cancer from coming back. It is not yet known whether giving combination~     chemotherapy together with cetuximab is more effective than giving combination chemotherapy~     alone in treating colon cancer.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab~     to see how well they work compared to combination chemotherapy alone in treating patients~     with stage III colon cancer that was completely removed by surgery.~   "
251062|NCT00265798|"~     This phase II trial is studying how well sorafenib works in treating patients with malignant~     gastrointestinal stromal tumor that progressed during or after previous treatment with~     imatinib mesylate and sunitinib malate. Sorafenib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
251063|NCT00265785|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating~     patients with stage III or stage IV non-small cell lung cancer.~   "
251064|NCT00265772|"~     The primary purpose of this study is to compare the efficacy of enteral nutrition compared to~     steroids in inducing remission of active pediatric Crohn’s disease. The main hypothesis of~     this study is that the use of enteral nutrition induces mucosal healing, whereas steroids do~     not. This effect may be related to a change of the commensal flora during enteral nutrition.~   "
251065|NCT00265759|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of~     estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not~     yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast~     cancer.~      PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole~     to compare how well they work in treating postmenopausal women who are undergoing surgery for~     stage II or stage III breast cancer.~   "
251066|NCT00265746|"~     Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at~     a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus,~     the experience of gestational diabetes is the strongest one. The incidence of various forms~     of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years.~      The aim of this study is a comparison of the efficacy of life style modification and life~     style modification in conjunction with metformin administration, in a population of women,~     who had already experienced gestational diabetes.~   "
251067|NCT00265733|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex and capecitabine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with~     capecitabine works in treating patients with metastatic breast cancer.~   "
251068|NCT00265720|"~     Colorectal cancer is the second deadliest among cancers and disproportionately affects~     African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as~     its goal to test three interventions designed to increase screening rates among medically~     underserved African Americans in the Metropolitan Atlanta area. It is designed to increase~     awareness of modifiable risk factors and promote the benefits of screening as a means of~     early detection of colorectal cancer. mportance of being screened for colorectal~     cancer,African Americans continue to be disproportionately affected by this disease. The~     Colorectal Cancer Screening~   "
251069|NCT00265707|"~     -  A disposable blood pressure measuring device will be tested and compared to a standard~          mercury sphygmomanometer.~        -  Up to 100 subjects with various levels of blood pressure values will be tested.~   "
251070|NCT00265694|"~     1. Recently a radomized trial of vinorelbine versus best supportive care in patients at 70~          years of age or older demonstrated a definite improvement in overall survival rate and~          quality of life with chemotherapy.~        2. The role of combination therapy containing the platinum compound, which is the standard~          therapy for the young patients is still vague.~        3. Gemcitabine and carboplatin have favorable toxicity profile.~   "
251071|NCT00265681|"~     The primary objective is to evaluate the effectiveness of telephone-based counseling in~     promoting smokeless tobacco cessation among residents of Minnesota. It is hypothesized that a~     greater proportion of individuals assigned to the proactive telephone calls will quit their~     use of smokeless tobacco products and all tobacco products compared to the comparison group~     not receiving those calls.~   "
251072|NCT00265655|"~     To determine the objective response rate (ORR) of oral satraplatin in patients with~     Metastatic Breast Cancer.~   "
251073|NCT00265642|"~     The purpose of this study is to examine the efficacy of irbesartan on the progression of~     liver fibrosis in adult patients with chronic hepatitis C.~      The expected total enrollment is 200 patients. Patients who meet the study criteria and~     accept to participate at this study will take by day one tablet of 150 mg of treatment~     (irbesartan or placebo) during two years. The assessment of efficacy will be make by~     evaluation of area of liver fibrosis and blood markers of liver fibrosis~   "
251074|NCT00265629|"~     This is an early feasibility trial designed to demonstrate whether a new ablation device can~     be used safely and effectively in treating atrial fibrillation.~      This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at~     a single study site~   "
251075|NCT00265616|"~     The purpose of this study is to determine whether propofol or barbiturates should be~     preferred in the treatment of status epilepticus (continuous seizure activity) refractory to~     2 standard antiepileptic agents.~   "
251076|NCT00265603|"~     The purpose of this study is to determine the safety of using a treatment called~     transimmunization in addition to standard therapy (radiation) in the treatment of lung~     cancer. Transimmunization is a treatment of the blood designed to boost the immune response~     against lung cancer. Transimmunization uses a device called a UVAR-XTS instrument, to remove~     a portion of blood, part of which is returned, and part of which is incubated overnight~     before being returned to the bloodstream the next day.~   "
251077|NCT00265590|"~     This study will examine specific gene changes in patients with aniridia, a disease in which~     the iris (colored part of the eye) is absent or partially absent, and will correlate the~     changes with clinical manifestations of the disease. In aniridia, the eye often appears to~     have no color, but only a larger than normal pupil. Patients may have impaired vision and~     cataracts, glaucoma, nystagmus (rapid, involuntary eye movements), photophobia (light~     sensitivity), displaced lens, underdeveloped retina, and thickened cornea. This study will~     focus particularly on corneal changes.~      Patients 4 years old and older with aniridia may be eligible for this study. Candidates are~     screened with a family history and complete eye examination, including the following:~        -  Visual acuity testing using a vision chart.~        -  Eye pressure measurement.~        -  Fundus photography to examine the back of the eye: The pupils are dilated and special~          photographs of the inside of the eye are taken to evaluate the retina and measure~          changes that may occur over time. The camera flashes a bright light into the eye for~          each picture.~        -  Slit lamp examination: Evaluation of the front part of the eye with a special microscope~          called a slit lamp biomicroscope.~        -  Corneal thickness measurement.~      Participants have blood drawn for genetic testing related to aniridia. Relevant medical~     information, including disease severity and complications, is obtained over time. Family~     members may also be requested to provide blood samples for genetic testing.~   "
251078|NCT00265564|"~     This study proposes a prospective program of research that will identify feasible and~     inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby~     improving substance abuse treatment outcomes.~   "
251080|NCT00265538|"~     This study examines the use of patient initiated discussions of blood pressure medication in~     the primary care setting. Additionally, this study examines different levels of patient~     incentive(s) to initiate discussions with providers including information only, information~     plus 20$ incentive and reimbursement for 6 months of copay, and information/monetary~     incentive plus a reminder call prior to the index visit. Patient opinions about~     doctor/patient relationships will be assessed. Provider attitudes and prescribing behaviors~     will be analyzed as well.~   "
251081|NCT00265525|"~     A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit)~     against usual care in increasing physical activity levels in patients with Coronary Artery~     Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a)~     have increased physical activity levels, b) will have a higher health-related quality of life~     at measurement dates and, c) will have greater improvements in psychosocial predictors.~   "
251082|NCT00265512|"~     The prevalence of substance use disorders (SUD) in the VA is rising, making SUD(s) among the~     most commonly diagnosed disorders in the VA. A substantial body of data attests to the~     effectiveness of substance use disorder treatment; further the predictor most consistently~     associated with positive addiction treatment outcomes is duration. Despite the body of~     evidence supporting length of treatment as one of the stronger predictors of long-term SUD~     outcomes, only 36% of SUD treatment programs in the VA are meeting the continuing care~     performance criterion specified by the Office of Quality Performance. This randomized~     clinical trial investigates whether substance use disorder patients assigned to telephone~     case monitoring (TCM) for continuing care will do better than those attending face-to-face~     continuing care as usual (CCAU)(standard outpatient care).~   "
251083|NCT00265499|"~     The purpose of this study is to determine whether skeletonization of the internal thoracic~     artery leads to improved flow, increased length, improved sternal perfusion, and decreased~     pain and dysesthesia in patients undergoing coronary artery bypass surgery~   "
251084|NCT00265486|"~     During facial cooling and especially during breath hold, can mammals - and also humans -~     elicit a so called dive reflex, causing bradycardia, peripheral vasoconstriction and~     centralization of blood flow to brain, lungs and heart but the reflex is suppressed by~     physical activity. The dive reflex can be elicited by breath hold alone and will be more~     pronounced during simultaneously facial cooling, but not by stimulation of other skin~     receptors.~      The dive reflex has an oxygen conserving effect, because of intense vasoconstriction in both~     viscera and muscles, and simultaneously with reduction in cardiac output (CO). Therefore~     plasma lactate will rise, to compensate for the lesser regional blood flow. If one~     hyperventilates with 100 % oxygen, then the reflex can still be elicited, but it is more~     pronounced during asphyxia. Experienced sports divers, who has been diving for more than 7-10~     years have reduced post apnea acidosis and oxidational stress, but probably also less~     sensitivity for progressive hypoxia and hypercapnia, because these individuals have a more~     pronounced dive reflex.~      Transcranial Doppler ultrasonography (TCD) gives a reproducibly value for brain perfusion by~     continuously non-invasive real-time sampling. A single piezo-electrical transducer sends and~     collects ultrasound through the temporal region of the scull, where it is the thinnest.~     Hereby can the blood flow of arteria cerebri anterior, media (MCA) and posterior and~     basilaris be estimated.~      With TCD it can be shown that the cerebral blood flow rises in MCA in healthy subjects during~     facial cooling, with normal ventilation, when resting in a supine position without affecting~     the systemic blood pressure. Single Photon Emission Computerized Tomography (SPECT)-scanning~     during normo-baric and hyperbaric pressure of professional divers breathing 100 % oxygen has~     shown to reduce the cerebral blood flow in several regions of the brain.~      But it is yet unknown how brain blood flow and metabolism are affected by an face immersion~     dive and simultaneously prolonged physical activity, and hence a rise in lactate under~     hyperbaric pressure (3 meters), breathing atmospheric air, similar to the circumstances for~     trained scuba divers work.~      Presumably it will cause a fall in brain blood flow and in time cognitive deficits.~      Erythropoietin (rhEPO) is a well known drug, used as doping in sports for about 15 years. So~     far the only known enhancement in athletic achievement by rhEPO is caused by peripheral~     improvements and especially blood capability to transport oxygen to the working muscles; this~     has been documented by a rise in haematocrit. rhEPO has also a neuroprotective effect on~     neurons in patients with neuron damage caused by cerebral hypoxic ischeamia.~      rhEPO work also on a series of cerebral mechanisms, including enhanced motor and spatial~     learning and more. Enhanced motor learning may improve the professional divers choices during~     work and may be also physical performance and mechanical efficiency. Intravenous injection of~     rhEPO will increase rhEPO in cerebrospinal fluids, since rhEPO is capable of crossing blood~     brain. All together this may indicate that rhEPO, not only works on physical performance, but~     also has effects on the brain. rhEPO has also an effect on the condition of cancer and~     dialysis patients, not only explained by merely increased hematocrit.~      This project will add new knowledge in the understanding of the mechanisms of clinical use of~     rhEPO.~      The purpose of this study is to investigate, how brain blood flow and metabolism are affected~     by face immersion dive and simultaneously breath hold during normo-baric and hyperbaric~     pressure (3 m depth) when breathing atmospheric air in trained sports divers. IL-6, HSP-72,~     lactate, ammonium and body-temperature will be measured. Brain and muscle oxygenation will be~     measured by near-infrared spectroscopi (NIRS). Furthermore we will investigate whether a~     small dose of rhEPO affects mentioned parameters during simulated dive in pressure chamber~     with facial cooling.~      Hypothesis Brain blood flow in trained divers will be diminished during prolonged physical~     activity during simultaneously face immersion dive and breath hold under hyperbaric pressure.~      There will be a release of IL-6 and HSP-72. Pretreatment with a small amount of rhEPO before~     prolonged physical activity during simulated dive has a protective effect on brain blood flow~     and oxygenation.~   "
251085|NCT00265473|"~     This clinical trial is designed to extend the observations made in our pilot clinical trial~     (IND 8971, Study #1) on the safety and efficacy of immunotherapy with the anti-CD3 monoclonal~     antibody hOKT3γ1 (Ala-Ala), (currently called MGA031) combined with sirolimus and tacrolimus~     in preventing rejection and autoimmune destruction of deceased donor pancreatic islet~     transplants in type 1 diabetic recipients.~   "
251086|NCT00265460|"~     The purpose of this trial is to examine if smokeless tobacco combined with group support~     might increase smoking cessation rate compared with groups support in smokers.~   "
251087|NCT00265447|"~     The purpose of this project is to establish evidence to support specific, targeted exercise~     and rehabilitation recommendations for people over 50 with osteoarthritis of the knee.~   "
251088|NCT00265434|"~     Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality~     of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a~     dysfunction of Chloride channels in exocrine glands, leading to retention of secretions and~     consecutive chronic inflammation with bacterial superinfections.~      The prospective placebo controlled cross-over study aims at the evaluation of the efficacy of~     a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.~   "
251089|NCT00265421|"~     We wish to determine wich of two standardized suturing techniques is the best for perineal~     repair if a perineal laceration or an episiotomy is present after vaginal birth.~      The participants are healthy primi para and deliver at term.~   "
251090|NCT00265408|"~     Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.~   "
251091|NCT00265395|"~     This is a controlled, randomized, parallel-groups, open-label, multinational study designed~     to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus~     Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether~     72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of~     treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to~     treatment.~   "
251092|NCT00265382|"~     The purpose of this study is to assess the safety and tolerability of ziprasidone during~     long-term open-label administration in adolescents (ages 13-17) with schizophrenia.~   "
251093|NCT00265369|"~     Primary objective:~        -  To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo~          in children suffering from acute diarrhoea and treated for 7 days.~      Secondary objective:~        -  To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.~   "
251094|NCT00265356|"~     The purpose of this trial is to improve the management of patients with potentially~     surgically curable colorectal cancer liver metastases.~      The primary objective is to determine the impact of pre-operative positron emission~     tomography (PET) on patients who have been assessed as having resectable colorectal cancer~     liver metastases by conventional imaging (computed tomography (CT) abdomen/thorax,~     colonoscopy), by determining the proportion of patients who have a change in management~     resulting from PET.~   "
251095|NCT00265343|"~     This is an extension study to further test~      the efficacy and safety of asenapine compared with a~      marketed agent (olanzapine) in the treatment of patients with~      persistent negative symptoms of schizophrenia.~   "
251096|NCT00265330|"~     The purpose of this study is to assess the safety and tolerability of ziprasidone during~     long-term open-label administration in children and adolescents (ages 10-17) with bipolar I~     disorder (manic or mixed)~   "
251097|NCT00265317|"~     This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib~     alone in patients with advanced/metastatic lung cancer who have received previous treatment~     with a platinum-based regimen~   "
251098|NCT00265304|"~     The purpose of this study is to evaluate the long-term safety of IDEA-033 (an~     anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an~     anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of~     both knees.~   "
251099|NCT00265291|"~     Our goal is to study pharmacogenetics in Mexican-Americans, using depression treatments as a~     proof of the concept that pharmacogenetic approaches can be used to optimize treatment~     strategies for common and complex disorders in this population.~   "
251100|NCT00265278|"~     The purpose of this study is to assess the potential interactions between intravenous~     methamphetamine and oral Modafinil.~   "
251104|NCT00265226|"~     The purpose of the study is to study the efficacy and safety of Mycobacterium in treating~     patients with lung tuberculosis . Mycobacterium is a strain of bacterium which is used as a~     vaccine and an adjuvant drug against leprosy. This agent has also been found to be effective~     in the treatment of lung tuberculosis in a limited number of patients.~      The researchers are conducting this study in the World Health Organization (WHO) category-II~     of lung tuberculosis patients to see the efficacy and also to see any change in immunological~     parameters.~   "
251105|NCT00265213|"~     we revise 8 disability items from SPADI into Chinese to develop a simple self-completion~     questionnaire for the assessment of restriction in daily activities resulting from breast~     conservative surgery.~      The purpose of this study was to validate the score obtained from this questionnaire by~     testing restriction of shoulder active flexion and abduction on examination at post BCS 2~     days correlates with disability score.~   "
251106|NCT00265200|"~     The purpose of this study is to evaluate a new blood test as a way to follow the effect of~     Zometa in treating bone metastases due to lung cancer.~   "
251107|NCT00265187|"~     Sputum specimens will be obtained from children < 2 years of age and processed by different~     mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical~     and epidemiological data will also be obtained.~   "
251108|NCT00265174|"~     Numerous studies document the ability of tumors to shed DNA into the blood stream.~     Circulating DNA can thus be recovered for analyses, representing a surrogate tumor material~     to test for potential applications in disease diagnosis and prognosis.~      Detection of genetic alternation is one of the most important tests for cancer patient since~     they offen correlated with the clinical course, prognosis and chemosensitivity of primary~     brain tumors. Currently in brain tumor patients these molecular aberrations can be analyzed~     only on tumor tissue that was obtained at surgery or biopsy.~      Paucity of pathologic samples or poor fixation technique often make the tissue samples~     unassessable for molecular aberrations.~      Therefore, the ability to extract tumor DNA from peripheral blood holds a great clinical~     significance. Still, the molecular aberration evaluated on serum DNA should be correlated and~     verified by comparison to standard evaluations performed on tumor samples. Our study aim is~     to evaluate the feasibility of using serum DNA for routine diagnosis of tumor molecular~     aberrations.~   "
251109|NCT00265161|"~     The study will be held in the winter of 2005-2007. The aim is to assess the effectiveness of~     the influenza vaccine in health care workers (HCW).~   "
251110|NCT00265148|"~     This is a placebo-controlled study evaluating the effects of rosiglitazone on functional~     brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD).~   "
251111|NCT00265135|"~     The purpose of this study is to better understand the safety, tolerability and distribution~     of CNTO 328 in the bloodstream.~   "
251112|NCT00265122|"~     The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants~     with active Crohn's Disease.~   "
251113|NCT00265109|"~     The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for~     people with body dysmorphic disorder.~   "
251114|NCT00265096|"~     The purpose of this study is to evaluate the safety and efficacy (improvement of signs and~     symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of~     active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and~     symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray~     related to joint damage, psoriasis skin lesions, physical function, and quality of life.~   "
251115|NCT00265083|"~     The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections~     (under the skin) of golimumab for the treatment of active ankylosing spondylitis~     [AS(arthritis of the spine)]. Efficacy will be measured by reduction in the signs and~     symptoms of active AS, including effects on back pain and stiffness, physical function, range~     of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.~   "
251116|NCT00265070|"~     This study is being carried out to see if ZD1839 is effective in treating prostate cancer~     after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.~   "
251117|NCT00265057|"~     N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer~     progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study~     will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a~     protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that~     subjects can tolerate.~   "
251118|NCT00265044|"~     To improve the quality of hypertension care in our facility, while concurrently, examining~     the relative contribution of each aspect of a multi-factorial intervention designed to~     improve hypertension care.~   "
251119|NCT00265031|"~     This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in~     the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is~     necessary following effective chemotherapy.~   "
251120|NCT00265018|"~     This study is designed to find the optimum radiation dose and number of cycles for an ABVD~     chemotherapy combined with an involved field irradiation. It is to be tested whether the~     reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20~     Gy is feasible without a loss of efficacy.~   "
251121|NCT00265005|"~     The purpose of this study is to determine if alteplase is effective in dissolving a clot in a~     catheter in a large vein (central venous line or PICC line) or artery in infants less than 6~     months of age.~   "
251122|NCT00264992|"~     Implantation failure of the embryo might be the result from the environment in the uterus.~     Proteins (cytokines) are screted by the endometrium which can result in a pro or anti~     inflammatory environment. The aim of this study is to identify pre-implantation endometrial~     and embryo cytokine expression profiles associated with successful and unsuccessful embryo~     implantation in assisted reproduction cycles.~   "
251123|NCT00264979|"~     The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has~     not still been defined. The purpose of this study is to compare two treatment strategies in~     which liver resection is performed either during, or 12 to 14 weeks after the primary~     resection. Endpoints include the rate of severe complications and survival.~   "
251124|NCT00264966|"~     To determine the safety and efficacy of multiple doses of ASM8 antisense oligonucleotides in~     asthmatics.~   "
251126|NCT00264940|"~     The prevalence of type 2 diabetes is rising in the population for many years. It is now~     recognized that a period of glucose intolerance precedes the clinical symptoms appearance.~     This is due to a combination of b-cell dysfunction and insulin resistance. It is estimated~     that this pre-clinical phase of type 2diabetes may antedate the onset of overt diabetes by~     10-12 years. Furthermore, insulin resistance is considered to be a main component of the~     metabolic syndrome and associated with significant cardiovascular morbidity and mortality.~     Recently, there has been an effort to pinpoint the pre-diabetic phase for early therapeutic~     intervention in the individual. These studies, in patients with impaired glucose intolerance,~     have shown to be beneficial from both lifestyle change and pharmacological intervention. It~     is thus hypnotized that intervention in patients with insulin resistance with or without~     glucose intolerance may prevent the progress of type 2 diabetes and it’s complications. There~     is difficulty in identifying individuals who are at high risk for type 2 diabetes. The~     prevention strategy relies on intervention in a pre-diseased state. In the case of type 2~     diabetes, the early intervention is useful in the phase where there is insulin resistance,~     but prior to the appearance of glucose intolerance. The diagnosis of insulin resistance is a~     challenging one. The gold standard in diagnosing insulin resistance is the~     hyperinsulinemic-euglycemic clamp, but this method is not suitable for routine clinical use.~     Thus, less invasive methods for evaluation, like homeostasis model assessment (HOMA) and~     quantitative insulin sensitivity check index (QUICKI), were developed. There is a correlation~     between HOMA and QUICKI results and the hyperinsulinemic-euglycemic clamp. Both HOMA and~     QUICKI allow insulin resistance diagnosis. The results from those tests correlate with~     hyperinsulinemic-euglycemic clamp and allow diagnosing insulin resistance, however, those~     indexes require serum glucose, insulin measurements and quite complicated calculations. A new~     method was suggested, non-invasive, sensitive and simple, for the identification of insulin~     resistance. In normal individuals, in the presence of insulin, glucose is taken up by a~     variety of cells, undergoes glycolysis and enters the tricarboxylic acid cycle or fat~     synthesis. In either case, CO2 in produced as a by-product. This CO2 enters the circulation~     and is discarded by the lungs. The new method is based on the assumption that 13C-glucose is~     ingested as described and its by-product 13CO2 can be measured in the expired air. In type 2~     diabetes and other states of insulin resistance glucose, uptake is impaired and results in~     blunted 13CO2 production. This hypothesis was tested by Lewanczuc et al. The writers compared~     the [13C]-glucose breath test with hyperinsulinemic-euglycemic clamp, HOMA and QUICKI~     indexes. They tested 26 patients at different stages of insulin sensitivity and reported a~     good correlation of the glucose breath test and the other indexes. We suggest testing a~     larger group of patients at high-risk to develop type 2 diabetes and compare the glucose~     breath test with HOMA index.~   "
251127|NCT00264927|"~     To assess the efficacy of SR121463B in correcting hyponatremia in patients with syndrome of~     inappropriate antidiuretic secretion (SIADH).To assess the long-term efficacy of SR121463B in~     maintaining normal levels of serum sodium in patients with SIADH. To assess the safety and~     tolerability of SR121463B in patients with SIADH.~      The double blind period is followed by an open label extension study with flexible doses of~     satavaptan.~   "
251128|NCT00264914|"~     To determine the long-term safety and tolerability of SR121463B in patients with syndrome of~     inappropriate antidiuretic secretion (SIADH). To assess the long-term efficacy of SR121463B~     in maintaining normal levels of serum sodium in patients with SIADH.~      Long term safety is evaluated further in an open label extension study with flexible doses of~     satavaptan.~   "
251129|NCT00264901|"~     This trial is conducted in the United States of America (USA). This trial aims for a~     comparison of the safety and efficacy in subjects with type 2 diabetes using either self~     titration or physician guided titration according to the local standard of care.~   "
251130|NCT00264888|"~     In some patients with Duchenne muscular dystrophy (DMD), the disease is caused by a nonsense~     mutation (premature stop codon) in the gene that makes the dystrophin protein. PTC124 has~     been shown to partially restore dystrophin production in animals with DMD due to a nonsense~     mutation. The main purpose of this study is to understand whether PTC124 can safely increase~     functional dystrophin protein in the muscles of patients with DMD due to a nonsense mutation.~   "
251131|NCT00264875|"~     To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated~     with HIV neuropathy~   "
251132|NCT00264862|"~     The aim of this study is to evaluate a new way to create CT-like images during~     intra-operative procedures. We want to prove that the quality and information received from~     DynaCT is satisfactory in implementing stent-graft in abdominal aortic aneurysm.~   "
251133|NCT00264849|"~     Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with~     severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to~     omalizumab over time will be assessed by physicians and patients evaluating the overall~     improvement in control of their asthma.~      THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.~   "
251134|NCT00264823|"~     The purpose of this research study is to investigate how nurses can best help people with~     serious mental illnesses (SMI) follow their HIV treatment plans.~   "
251135|NCT00264810|"~     The RNS® System Pivotal study is designed to assess safety and demonstrate that the RNS®~     System is effective as an adjunctive (add-on) therapy in reducing the frequency of seizures~     in individuals 18 years of age or older with partial onset seizures from no more than two~     foci (two areas of the brain) that are refractory (drug-resistant or hard-to-treat) to two or~     more antiepileptic medications. Patients continue to receive their epilepsy medications while~     participating in the study.~   "
251136|NCT00264797|"~     The purpose of this study is to determine the efficacy of osmotic-release methylphenidate~     (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.~   "
251137|NCT00264784|"~     The purpose of this ongoing study (Part V) is to evaluate the cause, distribution, control,~     and results of group A streptococcus infections (GAS) in Fiji. Patients of all ages~     presenting to the Colonial War Memorial Hospital, Suva, Fiji and patients donating blood to~     the Colonial War Memorial Hospital, Suva, Fiji may participate. Subject duration is less than~     one day. This study may help to develop a vaccine that will prevent group A streptococcal~     infections.~   "
251138|NCT00264771|"~     The purpose of this ongoing study (Part II) is to estimate the incidence of acute rheumatic~     fever, rheumatic heart disease, acute post-streptococcal glomerulonephritis (kidney disease),~     and invasive group A streptococcal (GAS) disease (strep infection) in Fiji to help develop~     better treatments and vaccines. Group A streptococcal disease is caused by the bacterium~     group A streptococcus. It is commonly found in the nose and throat of normal healthy adults~     and children, and can cause illness. The bacterium is spread by close contact with patients~     or carriers, through things like coughing, sneezing, kissing, or sharing a drink and can~     cause a wide variety of illnesses. These illnesses may be a sore throat, skin sores, and less~     commonly acute rheumatic fever or kidney disease. Participants of all ages will be recruited~     through the Colonial War Memorial and Lautoka Hospital. A blood sample will be collected from~     each study participant. Subject participation should be less than one day.~   "
251158|NCT00264511|"~     Study hypothesis :Hyperbaric Oxygen may prevent complications and improve outcomes in severe~     lower limb trauma. We propose to investigate this hypothesis by conducting an International~     multi centre randomised control trial of standard trauma/orthopaedic care with or without a~     concurrent course of hyperbaric oxygen treatments.~   "
251139|NCT00264758|"~     The Frequent Hemodialysis Network (FHN) Daily Trial is a randomized controlled trial~     recruiting subjects from dialysis units associated with designated Clinical Centers in the~     U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional~     hemodialysis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per~     week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The~     study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months~     in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with~     the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life~     scale.~   "
251140|NCT00264745|"~     The purpose of this study is to test a new educational program for families taking care of~     persons who have had a stroke. Caregivers are asked what they think of the TASK program and~     how to make it better. After getting the TASK program, their ability to provide care will be~     compared with a group that did not receive the TASK program.~   "
251141|NCT00264732|"~     The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the~     treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.~   "
251142|NCT00264719|"~     Hypothesis: Early use of oral metoclopramide can hasten and improve the establishment of~     lactogenesis II in mothers after preterm and term deliveries.~      The study hopes to show that metoclopramide can be effective to establish and sustain~     Lactogenesis II for both preterm and term infants.~   "
251143|NCT00264706|"~     The primary objectives of this trial are: 1) to evaluate the safety of NONA-L-ARGININE in ex~     vivo application to saphenous vein segments prior to grafting; and, 2) to obtain preliminary~     data on the biological effects of NONA-L-ARGININE, as compared to placebo, in the prevention~     of neointimal hyperplasia.~   "
251144|NCT00264693|"~     Low molecular weight heparins (LMWH) have been shown to be at least as efficient and safe as~     unfractioned heparin (UFH) in prophylaxis and treatment of venous thromboembolic events and~     in therapy of acute cardiovascular diseases. LMWH are widely used as safe replacement of oral~     anticoagulation with vitamin K antagonists (VKA).~      Due to their pharmacokinetic characteristics, LMWH tend to accumulate in patients with~     impaired renal function. Official guidelines recommend therefore to use LMWH controlled by~     Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation~     therapy in patients with severe renal insufficiency.~      Although dosage recommendations have been proposed for enoxaparin in patients with renal~     impairment based on several studies, these data cannot be applied to other LMWH directly due~     to different pharmacokinetic properties of each drug.~      The present study aims to clarify the pharmacokinetics of dalteparin in patients with renal~     insufficiency, especially addressing the question of accumulation after multiple doses and~     including patients with severe renal insufficiency and derive a safe and suitable concept for~     using dalteparin in patients with impaired renal function.~   "
251145|NCT00264680|"~     Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients~     treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic~     patients treated with lamotrigine or valproic acid. Determination and assessment of the~     comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image~     perception in women treated with lamotrigine or valproic acid.~   "
251146|NCT00264667|"~     Study in patients with dyslipidaemia.~   "
251147|NCT00264654|"~     This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)~   "
251148|NCT00264641|"~     The purpose of this study is to evaluate the cerebral blood flow in subjects with high and~     low activity in the renin-angiotensin system (RAS).The renin-angiotensin system is a hormone~     system which is involved in the regulation of the blood pressure. Earlier studies have shown~     that high RAS activity is associated with a more pronounced cognitive impairment during~     hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy~     volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning~     during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers~     with high and low RAS activity, respectively~   "
251149|NCT00264628|"~     The purpose of the study is to investigate safety, tolerability and efficacy of oral GW679769~     up to 120 mg dose compared to placebo in patients with ACR(American College of~     Rheumatology)-defined fibromyalgia, co-morbid with depression.~   "
251150|NCT00264615|"~     Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy~     patients when switching from LAMICTAL immediate-release to extended-release and vice versa.~   "
251151|NCT00264602|"~     The primary purpose of this study is to determine if we can identify the first lymph node~     that drains from the tumor, and thus would be the most likely site for metastatic disease,~     and remove it for analysis to improve the ability to detect tumor in this node and to remove~     this additional site that potentially contains tumor cells.~   "
251152|NCT00264589|"~     Obesity and diabetes increase cardiovascular risk by complex and incompletely known~     mechanisms. The aims of this study are :~        1. to compare cardiac and vascular functions at rest and during exercise in 4 groups of~          age-matched men, without cardiovascular diseases but exhibiting increasing~          cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic~          subjects~        2. to test the effects of a 8-weeks long individualized training program on these functions~          in obese subjects and in diabetics patients.~   "
251153|NCT00264576|"~     The purpose of this study is to evaluate the safety and immunogenicity of cell~     culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin~     vaccine administered to healthy adults ages 18 < 50 years.~   "
251154|NCT00264563|"~     Iatrogenesis is inevitable in the NICUs.~   "
251155|NCT00264550|"~     The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in~     combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid~     arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.~   "
251156|NCT00264537|"~     The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in~     combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis~     subjects who have not been previously treated with methotrexate.~   "
251157|NCT00264524|"~     The current study was designed to determine whether the HLA-DRB1, DQA1, DQB1 alleles are~     associated with the risk and the pattern of valve damage of RHD.~   "
251159|NCT00264498|"~     The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage~     IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839~     compared to gemcitabine/carboplatin.~   "
251160|NCT00264485|"~     The purpose of this study is to compare two pain medications delivered by two different forms~     of patient-controlled analgesia (PCA) management systems: the Fentanyl HCl Patient-Controlled~     Transdermal System (E-TRANS fentanyl) and the morphine intravenous pump. Fentanyl HCl and~     morphine are narcotic pain relievers. The E-TRANS fentanyl system is a small unit worn on the~     patient's upper outer arm or chest that uses low-intensity electrical current to deliver~     fentanyl through the skin and into the patient's bloodstream. The patients studied will be~     those who have just received a total hip replacement.~   "
251161|NCT00264472|"~     5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly~     inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This~     study will test the safety and effects of oral ADH300004 14 hours prior to oral 5 FU in~     subjects with refractory solid tumors.~   "
251162|NCT00264459|"~     The trial is performed to asses efficacy and safety of a sublingual extract of a six grass~     pollen mixture~   "
251163|NCT00264446|"~     5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly~     inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This~     study will examine the kinetics of inhibition and recovery of the metabolic pathways for~     fluoropyrimidines in subjects who receive a single oral dose of ADH300004, and may allow~     optimization of oral 5 FU dosing to subjects in future studies.~   "
251164|NCT00264433|"~     N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer~     progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study~     will test the safety and effects of ADH-1 in subjects with specific incurable, solid tumors~     with a protein biomarker called N-cadherin. This study will examine the clinical activity of~     ADH-1.~   "
251165|NCT00264420|"~     Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates~     are used in bone metastases to keep the cancerous lesion under control in the bone and to~     help prevent calcium level elevations in the blood. Cancer cell-culture studies at the~     Cleveland Clinic showed that zoledronic acid and radiation together have more cell killing~     effect than either one used alone. The purpose of this study is to monitor the healing of~     bone lesions when using zoledronic acid together with radiation treatment.~   "
251166|NCT00264407|"~     The purpose of this study was to determine the effects of hormone replacement therapy (HRT)~     on hearing in post-menopausal women.~   "
251167|NCT00264394|"~     There is growing evidence that antiretroviral therapy (ART) increases the risk of coronary~     heart disease (CHD) through metabolic side effects, such as dyslipidemia, insulin resistance,~     and type II diabetes. Prevalence of risk factors for CHD in HIV-infected individuals~     receiving ART in the Swiss HIV Cohort Study (SHCS) is high. This cluster randomised~     controlled trial is nested into the SHCS and will investigate whether physicians randomised~     to the routine provision of risk profiles from their patients receiving ART will improve the~     management of risk factors in HIV-infected patients compared to control physicians not~     routinely receiving such information. Risk profiles will be generated by the SHCS data center~     and provided to clinicians in all study centers.~   "
251168|NCT00264381|"~     The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium)~     subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three~     times daily for 7 days for the treatment of superficial thrombophlebitis (STP).~   "
251169|NCT00264368|"~     In order to optimize anti-cytomegalovirus (CMV) treatment with ganciclovir (GCV), in patients~     with multi organ failure treated with continuous renal replacement therapy (RRT), more~     information about ganciclovir pharmacokinetics in this setting is needed.~      The primary objective is to describe the pharmacokinetics of ganciclovir in critically ill~     patients with acute renal failure treated with continuous renal replacement therapy, with a~     special emphasis on the extra-renal clearance and distribution volume.~      Secondary objectives are to investigate if any co-factors, such as serum creatinine, weight,~     general hydration status, rest function of the native kidneys, etc. can help to describe the~     pharmacokinetics of GCV in these patients on continuous RRT as well as the relative influence~     of filtrations and dialysis on GCV elimination during different modalities of the treatment.~   "
251170|NCT00264355|"~     Following heart transplantation many patients develop acute renal failure in the early~     posttransplant phase and some are in need of renal replacement therapy for shorter or longer~     time. The cause of this acute renal failure is most probably multi factorial but many reports~     indicate that cyclosporine has a central role in the pathophysiology and it is generally~     recommended to lower the cyclosporine load to patients developing acute renal failure in this~     population.~      Several in vitro studies on renal cells in culture indicate that the primary metabolites of~     cyclosporine (AM1, AM9, AM4N) are less toxic to the kidney than cyclosporine itself. However,~     the secondary metabolite AM19 as well as the cyclic metabolites AM1c and AM1c9 has been~     associated with decreased renal function and nephrotoxicity renal transplant recipients.~      The primary objective of this pilot study is to investigate if the concentrations of~     secondary- and cyclic metabolites of cyclosporine (AM19, AM1c, AM1c9) is related to~     development of acute renal failure in the early posttransplant phase following heart~     transplantation.~      Secondary objectives are to investigate associations between genotypes of P-glycoprotein and~     CYP3A5 and the metabolic pattern of cyclosporine.~   "
251171|NCT00264342|"~     This is a 2-year study involving the progressive reduction in the nicotine content of~     cigarettes. The investigators believe that at the end of the study smokers of cigarettes with~     progressively reduced nicotine content will be weaned from nicotine. At the end of the~     study, the result will be a decreased level of nicotine dependence. When smokers are again~     free to choose any smoking behavior, they will smoke fewer cigarettes and/or have a greater~     interest in quitting compared to a control group that smokes their usual cigarettes.~   "
251190|NCT00264095|"~     The purpose of this study is to observe the methods used to manage blood loss in surgical~     procedures to remove tumors from patients with cancer and to determine if there is a~     relationship with the need for blood transfusions.~   "
251172|NCT00264329|"~     To address the issues involved in treatment participation by substance-abusing parolees, the~     CJ-DATS Transitional Case Management (TCM) study proposes to test a parole re-entry model~     that consists of (1) completion by the inmate of a strengths and goals assessment as part of~     discharge planning, (2) a telephone case conference call that includes the inmate and~     significant members of the inmate's aftercare plan (including the parole officer), and (3)~     strengths case management (for 12 weeks) in the community to promote treatment participation~     and support the client's access to needed services.~   "
251173|NCT00264316|"~     The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is~     limited by postinfarction left ventricular (LV) dysfunction.The purpose of this study is to~     determine whether intracoronary transfer of bone marrow cells will augment left ventricular~     function recovery of the heart.~   "
251174|NCT00264303|"~     A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in~     patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus~     severity score over the first week of treatment~   "
251175|NCT00264290|"~     The purpose of this study is to determine whether treatment with valganciclovir decreases T~     cell activation levels among HIV-infected patients with asymptomatic cytomegalovirus (CMV)~     co-infection, potentially improving immune responses to antiretroviral therapy.~   "
251176|NCT00264277|"~     The optimal duration of oral anticoagulant treatment in patients with idiopathic venous~     thromboembolism is still uncertain. The present study addresses the possible role of the~     D-dimer test in assessing the need for continuation of anticoagulation.The study aims at~     assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in~     these patients~   "
251177|NCT00264264|"~     Hemostasis at the arterial puncture site after percutaneous coronary interventions is~     achieved by either placement of a puncture closure device or by delaying sheath removal for~     hours to allow normalization of heparin induced anticoagulation. Both of these methods are~     far from ideal. Delayed sheath removal poses a risk of recurrent bleeding, hematoma formation~     and results in decreased patient mobility while the safety of closure devices has been called~     into question by several recent reports. Due to the lack of definitive data, the arterial~     access site management varies considerably between physicians and among institutions. The~     proposed study will evaluate the safety and efficacy of arterial closure devices to achieve~     hemostasis compared with immediate sheath removal after protamine administration followed by~     direct compression after percutaneous coronary intervention procedures.~   "
251178|NCT00264251|"~     The purpose of this study is to determine if, in men and women with excess abdominal fat and~     insulin resistance, people with HIV infection respond differently than people without HIV to~     interventions that typically improve body fat distribution and insulin resistance. The~     specific interventions are:~        1. Diet + exercise program.~        2. Rosiglitazone treatment.~        3. A combination treatment of diet + exercise program and rosiglitazone.~   "
251179|NCT00264238|"~     The purpose of this study is to determine whether memantine is safe and effective when used~     as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD).~   "
251180|NCT00264225|"~     This study aims to assess the analgesic effectiveness and safety of three different doses of~     a new formulation of Lamaline® versus Dafalgan® Codeine after 10 days administration in~     subjects with painful gonarthrosis~   "
251181|NCT00264212|"~     To compare the antihypertensive efficacy and tolerability of irbesartan and~     irbesartan-hydrochlorothiazide fixed combination therapy with amlodipine and amlodipine plus~     hydrochlorothiazide in the treatment of isolated systolic hypertension.~   "
251182|NCT00264199|"~     The purpose of this study is to determine whether 48 hours of glucagon-like-peptide-1 (GLP-1)~     infusion can improve heart function and alter substrate metabolism in non-diabetic patients~     with heart failure.~   "
251183|NCT00264186|"~     Inflammation is characterised by an increased risk for cardiovascular events. Dysfunction of~     the vascular endothelium caused by oxidative stress might provide a mechanistic link. In~     acute and chronic inflammation, oxidative stress occurs when the production of reactive~     oxygen species [ROS] (including superoxide anions [O2-]) exceeds the capacity of the~     endogenous antioxidant defense systems, resulting in ROS-mediated damage. Recombinant human~     superoxide dismutase (rhSOD) has shown potent antioxidant properties in in-vitro and animal~     studies and has been tested in phase I clinical trials in humans. rhSOD could offer a~     therapeutic option for vascular dysfunction in diseases associated with increased oxidative~     stress. The investigators, therefore, want to test if the hyporesponsiveness to vasoactive~     drugs (norepinephrine, acetylcholine and glyceroltrinitrate) during acute inflammation by~     low-dose lipopolysaccharide (LPS) is due to the increased production of superoxide anions,~     which could be scavanged by the radical scavenger rhSOD.~   "
251184|NCT00264173|"~     Primary Objective :~        -  To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a~          manic or a mixed episode according to DSM IV TR (APA 2000) [Diagnostic and Statistical~          Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)] and over a~          periode of 3 weeks and 12 weeks of treatment~      Secondary Objective :~        -  To evaluate the clinical and biological safety of valproate compared to lithium.~   "
251185|NCT00264160|"~     This open-label, multicenter trial will evaluate the efficacy and safety of treatment with~     AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to~     imatinib mesylate therapy.~   "
251186|NCT00264147|"~     To assess the clinically active dose range of study medication in the treatment of patients~     with rheumatoid arthritis.~   "
251187|NCT00264134|"~     Primary Objective: To determine the maximum tolerated dose of docetaxel when given with~     Irinotecan and Carboplatin for the treatment of inoperable lung cancer.~      Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in~     patients with inoperable lung cancer.~   "
251188|NCT00264121|"~     The purpose of this study is to determine the incidence of congenital undescended testis of~     mature boys, at one year of age, born in the Medical Centre Alkmaar (MCA).~   "
251189|NCT00264108|"~     The purpose of this study is to evaluate the cost-effectiveness of epoetin alfa compared with~     darbepoetin alfa in the treatment of anemia in adults receiving chemotherapy for cancer.~     Epoetin alfa and darbepoetin alfa are genetically engineered proteins that stimulate red~     blood cell production.~   "
251191|NCT00264082|"~     The purpose of this research study is to evaluate the usefulness of the TRAP protein as (1)~     an early indicator of bone destruction and (2) a tool for assessing the effect of Zometa® in~     treating symptoms of bone metastases due to breast cancer. Tartrate-resistant acid~     phosphatase (TRAP) is a protein released into the blood stream as a result of bone~     destruction caused by metastasis of breast cancer to the bone. Bone destruction causes pain~     and bone fractures. This study will measure TRAP levels in serum taken from breast cancer~     patients to see if TRAP levels will be able to predict the effect of Zometa® treatment on~     bone destruction, pain and bone fractures.~   "
251192|NCT00264069|"~     The purpose of this study is to find out how well new treatment plans are followed by~     outpatients with major mental illnesses (schizophrenia, bipolar disorder, depression,~     personality disorder) and to determine the relationship between a diagnosis of schizophrenia~     and compliance with a treatment plan.~   "
251193|NCT00264056|"~     The incidence of malignant melanoma continues to rise throughout the world. Approximately 12~     in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is~     often very aggressive since it may spread both through the lymphatic system and the~     bloodstream at an early stage of disease.~      While treatment of localized disease is mostly surgical, in patients with extensive disease,~     prognosis remains poor; the primary standard therapy of metastastic disease comprises~     dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or~     BCNU. The duration of response to systemic chemotherapy is generally short and so far, no~     standard second-line treatment has been established.~      To study the potential additional therapeutic effects of regional hyperthermia in advanced~     malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases,~     in the present trial, we sought to compine local hyperthermia with concomitant systemic~     second-line chemotherapy.~   "
251194|NCT00264043|"~     The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx~     Velocity™ on patient outcome at one month.~   "
251195|NCT00264030|"~     The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial~     reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.~   "
251196|NCT00264017|"~     In the past ten years, newer drugs with more selective affinity for the alpha-receptor have~     been introduced. Alfuzosin (Uroxatral) and Tamulosin(Flomax are two second generation~     alpha-blockers. In the course of our clinical proctice, both drugs have been used routinely.~     This retrospective comparison is intended to be a priliminary comparison of their~     effectiveness and side effects.~   "
251197|NCT00264004|"~     The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be~     well tolerated without significant drug withdrawal when accompanied by a suitable~     hypertension management strategy or dose reduction.~   "
251198|NCT00263991|"~     Primary headache disorders are now accepted as physiological diseases, and advanced~     imaging-techniques have demonstrated a migraine generator in the brain stem and increased~     stimulus sensitivity in these patients. The underlying neuronal dysfunctions remain to to~     clarified and the existing neurophysiological methods have not yet been useful. More~     sensitive and reliable methods are therefore highly needed. The aims of the study are~     therefore to develop a sensitive and reliable method to demonstrate a cortical reorganisation~     and expansion of pain sensitive cortical areas in patients with migraine or tension-type~     headache.~   "
251199|NCT00263978|"~     Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood~     and marrow transplantation. Treatment with currently available (Food and Drug Administration~     [FDA] approved) agents fails in most cases. Recently conducted clinical studies indicate that~     patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed~     not with a research intent, but rather to ensure that defibrotide is used by the blood and~     marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a~     safe, effective and ethical manner.~   "
251200|NCT00263965|"~     This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and~     active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2~     diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and~     1-week placebo single-blind baseline measurement period, the patients will be given the~     investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up~     during the first 3 weeks of the double-blind period. The total study duration, including~     enrollment, run-in, randomized treatment and follow-up, is 29 weeks.~   "
251201|NCT00263952|"~     The trial is performed to assess efficacy and safety of a purified standardised bee venom~     preparation in bee venom allergy~   "
251202|NCT00263939|"~     The purpose of the study is to determine the effectiveness of a home-delivered variant of the~     chronic disease self management program in improving health outcomes in patients with chronic~     conditions.~   "
251203|NCT00263926|"~     The trial is performed to assess efficacy and safety of a purified standardised wasp venom~     preparation in wasp venom allergy~   "
251204|NCT00263900|"~     The aim of this study is to evaluate the impact of the use of a quick diagnostic test of~     infection with RSV and influenza virus on the assumption of clinical responsibility of the~     children consulting at the Paediatric Emergency Unit.~   "
251205|NCT00263887|"~     The goal of this trial was to explore the utility of evaluating emphysema progression through~     CT scans measuring lung density during a 2 year period of weekly infusions of either placebo~     or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries~     were also collected. All efficacy data were analyzed for potential use in evaluating~     Prolastin efficacy in this and other clinical trials.~   "
251206|NCT00263874|"~     This initial proof of concept, phase II study aims to assess the safety and efficacy of~     UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary~     Disease.~   "
251207|NCT00263861|"~     RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may~     help patients live more comfortably.~      PURPOSE: This clinical trial is studying nerve function in older diabetic patients who are~     undergoing chemotherapy for metastatic solid tumors.~   "
251208|NCT00263835|"~     The purpose of this study is to modify and evaluate a culturally appropriate intervention~     that is designed to improve diabetes self-care practices by enhancing the self-efficacy,~     empowerment and diabetes knowledge among Latino adults over the age of 55 years.~   "
251209|NCT00263822|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Sometimes after treatment, the tumor may not need additional~     treatment until it progresses. In this case, observation may be sufficient. It is not yet~     known whether erlotinib is more effective than observation after first-line chemotherapy in~     treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.~      PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works~     compared to observation in treating patients who have undergone first-line chemotherapy for~     ovarian cancer, peritoneal cancer, or fallopian tube cancer.~   "
251210|NCT00263809|"~     The primary objective of the study is to measure platelet corrected count increments and the~     incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected~     count increment measured 1-hour post transfusion in response to the infusion of platelet~     concentrates treated with the Mirasol PRT System device (test product) versus untreated~     (reference product).~   "
251211|NCT00263796|"~     To study the effect of oxytocin on face processing and response inhibition in autistic adults~     by fMRI.~   "
251212|NCT00263783|"~     To determine the safety profile of single and multiple doses of MEDI522 in patients with~     refractory solid tumors.~   "
251213|NCT00263770|"~     The purpose of the study is to compare the effectiveness of soft palatal implants with~     placebo and continuous positive airway pressure treatment in obstructive sleep apnea.~   "
251214|NCT00263757|"~     This randomized, controlled trial is designed to test whether treatment of sleep disordered~     breathing (SDB) with positive airway pressure (PAP) therapy alters the natural history of~     atrial fibrillation (AF). Patients with recent AF who are now in sinus rhythm, and found to~     have SDB (obstructive and/or central sleep apnea) by formal sleep study but without~     complaints of daytime sleepiness, are randomized to PAP therapy to eradicate SDB or to usual~     care (medical management as prescribed by the patient's cardiologist).~   "
251215|NCT00263744|"~     The primary objective of this study is to describe the safety of 40 mg MEDI-517, with a~     control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16~     and/or HPV-18 DNA detected in cervical brushings.~   "
251216|NCT00263731|"~     The purpose of this study is to learn more about the metabolic properties of lung cancer~     cells.~   "
251217|NCT00263718|"~     The objective of the study is to compare the use of calcipotriol plus betamethasone~     dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel~     vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk~     and/or limbs. Patients will be treated once daily for up to 8 weeks.~      The primary response criterion is the number of patients with controlled disease at week 8.~   "
251218|NCT00263705|"~     Determination of guidelines regarding the use of adjuvant chemotherapy for early breast~     cancer in this population of Patients over 70 years old.~   "
251219|NCT00263692|"~     The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals'~     combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when~     administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years~     when co-administered with MMR vaccine in subjects who had previously received four doses of~     Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.~   "
251220|NCT00263679|"~     The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK~     Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school~     children and adolescents (9-13 years of age) previously vaccinated with five consecutive~     doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control~     vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and~     safety assessments.~   "
251221|NCT00263666|"~     The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK~     Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines~     including OPV in HIV positive infants. The Protocol Posting has been updated in order to~     comply with the FDA Amendment Act, Sep 2007.~   "
251222|NCT00263653|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a~     booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles,~     mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy~     subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa~     -containing vaccine) and MenC-CRM197.~   "
251223|NCT00263640|"~     The trial is performed to assess efficacy and safety of the Allergopharma house dust mite~     allergoid in bronchial asthma.~   "
251224|NCT00263627|"~     The aim of this clinical trial is to show safety and efficacy of the allergoid preparation of~     birch pollen allergens in the treatment of birch allergic patients in a representative number~     of patients.~   "
251225|NCT00263614|"~     To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or~     less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated~     liver transaminases have histological evidence of active liver disease.~   "
251226|NCT00263601|"~     The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in~     Allergic Rhinoconjunctivitis~   "
251227|NCT00263588|"~     Determine how safe and effective lapatinib is when used to treat patients with ErbB2~     overexpressing breast cancer that has spread to the brain and is still progressing there even~     after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic~     radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for~     safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during~     the course of the study.~   "
251228|NCT00263575|"~     The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in~     treating breakthrough pain episodes in opioid cancer patients who are using stable doses of~     opioid medication.~   "
251238|NCT00263432|"~     Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain~     a repair and prevention of secondary osteoarthritis~   "
251239|NCT00263419|"~     The purpose of this study is to determine whether a structured stress relief management~     program can prevent the progression of late diabetic complications in patients with type 2~     diabetes.~   "
251240|NCT00263406|"~     Randomisation between postoperative administration of an ACE-inhibitor or not.~   "
251229|NCT00263562|"~     The painful episode is the most common problem experienced by children with sickle cell~     disease. Although various treatments are available during painful episodes, the medication~     most commonly given for pain is a pain medication such as morphine. Fluids are also used.~     Even with these treatments, many children still have severe pain that is difficult to~     control. In addition to pain medications, there are other medications that may be useful.~     Methylprednisolone (solumedrol) and prednisone are a group of medications called steroids~     that may be helpful for painful episodes. These medications are known to lower the amount of~     inflammation (this means swelling, tenderness, and soreness) in the body. Because this~     medication may help with your pain, you are being asked to be a part of this study. These~     types of medications are used in other illnesses such as asthma, especially during times when~     the illness has gotten worse.~      The main purpose of this study is to see if the methylprednisolone and prednisone will lower~     the amount of pain and the length of hospital stay.~      In addition to the pain medication you will normally receive, you will be assigned to one of~     2 groups: 1) the experimental group with the active form of the medicine, or 2) a comparison~     group without the active form of the medicine. In either group, you will still receive all of~     the treatments you would normally receive for a painful episode, including pain medicines and~     fluids. You and your doctors will not know what group you will be assigned.~      If you decide to be a part of the study the following will happen:~      For the first 5 days, you will be asked to: 1) describe your current pain (0=no pain to 10=a~     lot of pain), worst pain (0=no pain to 10=a lot of pain), least pain (0=no pain to 10=a lot~     of pain), and the amount of pain relief (0=no relief to 10=complete relief); 2) describe any~     signs or symptoms you feel, including filling out a pain scale form each day; 3) and take the~     medicines for 5 days, either at home or when in the hospital. Thirty days after the study, a~     study researcher will call and will ask questions about your pain, any painful episodes, and~     any medications you had. If you are discharged home sooner than 5 days after the start of the~     study, research staff will call you to ask you these questions, remind you to fill out your~     pain forms, and remind you to take your medicine. If you are discharged home, you will be~     given pain scales to fill out each day at home.~   "
251230|NCT00263549|"~     The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic~     Rhinoconjunctivitis~   "
251231|NCT00263536|"~     This study will examine whether family-based interpersonal psychotherapy (FB-IPT) is an~     effective tool for helping pre-adolescent girls and boys at risk for become obese to reduce~     weight gain. IPT is a time-limited group therapy for preventing and treating depression in~     children. It is also effective for treating binge eating disorder in adults and has resulted~     in weight maintenance or modest weight loss in obese adults. IPT focuses on improving how~     people relate to one another by relating symptoms to personal problem areas and then~     developing strategies for dealing with these problems. Girls and boys between the ages of~     8-13 years of age who are in good general health with the exception of being overweight and~     whose body mass index (BMI) is above the 85th percentile for their age and sex may be~     eligible for this study. Candidates are screened with a physical examination, measurement of~     their height and weight, blood and urine tests, a DEXA scan (x-ray scan that measures body~     fat, muscle and bone mineral content), and questionnaires and an interview to obtain~     information about the child's general health, social and psychological function, and eating~     patterns. Parents are also screened for their health and are asked to give blood samples for~     genetic studies and participate in a few questionnaires and interviews.~      Participants are randomly assigned to participate in FB-IPT or a health education program.~     Both programs involve 12 weekly visits. At the end of the study, the body weight and mood of~     the girls and boys in both groups are compared.~      Participants (a parent and their child) meet individually with the therapist for 12 sessions~     (each approximately an 45 minutes ). Girls and boys offered FB-IPT have meetings in which~     they develop strategies for dealing with the problems girls struggle with that may lead to~     increased eating. Girls and boys in the health education group have meetings that focus on~     teaching teens children to live healthier lives and review topics related to developing and~     maintaining healthy eating and exercise.~      All participants are evaluated at the end of the 12-week program and asked to return to the~     NIH for follow-up visits at post treatment, 6 and 12 months following initiation of the~     program.~      Each child and parent will be compensated for their time and inconvenience with $40 for~     completing all pre-program assessments, $40 for attending the 12 week follow-up visit, $40~     for the 6 month follow-up visit, and $40 for the 1-year follow-up. Therefore, each child may~     receive up to $160, and the participating parent may receive up to $160. If a child's second~     biological parent is also willing to give a genetic sample and undergo interviews, the second~     parent can also receive $40 for a single visit to the NIH.~   "
251232|NCT00263523|"~     This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI)~     to measure a serotonin receptor subtype in the brain called 5-HT(1A). This receptor is a~     target for drug therapy to treat anxiety and depression. The study will see if a newly~     developed radioligand (radioactive substance used in PET scanning to study the receptor~     systems of the brain) called [(11)C](-)-RWAY is more effective than other radioligands~     currently used in brain receptor research.~      Healthy subjects 18-40 years of age may be eligible for this study. Candidates are screened~     with a physical examination, electrocardiogram, and blood and urine tests.~      Participants undergo PET and MRI scanning as follows:~      PET scan~      PET uses small amounts of a radioactive chemical called a tracer (in this case,~     [(11)C](-)-RWAY) that labels active areas of the brain. For the procedure, the subject lies~     on the scanner bed. A special mask is fitted to the subject's head and attached to the bed to~     help keep the head still during the scan so the images will be clear. A brief scan is done~     just before the tracer is injected to provide measures of the brain that will help in the~     precise calculation of information from subsequent scans. Then, the tracer is injected~     through a catheter (plastic tube) placed in the arm and pictures are taken for about 2 hours,~     while the subject lies still on the scanner bed. Subjects return to the clinic for blood and~     urine tests 24 hours after the scan.~      MRI~      The MRI scan is done within 1 year of the PET scan. MRI uses a magnetic field and radio waves~     to produce images of body tissues and organs-in this case, the brain. The subject lies on a~     table that is moved into the scanner (a tube-like device), wearing earplugs to muffle the~     noise of the machine during the scanning process. The space in the scanner is confining and~     may cause some people to be somewhat anxious. An intercom system allows the subject to speak~     with the staff member performing the study at all times during the procedure, and the~     procedure can be stopped at any time.~   "
251233|NCT00263497|"~     Most trauma survivors in low-income countries develop post-injury chronic pain syndromes.~     Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting. The~     actual study aims at reducing post-injury chronic pain and improving function by immediate~     temporary prosthesis fitting after surgery.~   "
251234|NCT00263484|"~     The purpose of this study is to determine whether lower than conventional doses of~     dexamethasone and thalidomide; and a higher dosing frequency of zoledronic acid are effective~     in the treatment of newly-diagnosed multiple myeloma.~   "
251235|NCT00263471|"~     7-methylxanthine has been shown to increase the concentration and thickness of collagen~     fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of~     childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize~     the sclera and prevent further progression of myopia.~   "
251236|NCT00263458|"~     The purpose of this study is to assess the feasibility, cost, and effectiveness of a model of~     care designed to integrate buprenorphine treatment for opioid dependence into the HIV primary~     care clinics at the UCSF Positive Health Program.~   "
251237|NCT00263445|"~     Serum insulin-like growth factor-I (IGF-I) measurements have been shown to correlate well~     with growth hormone action and effect, and recent data show that serum IGF-I may be related~     to safety and efficacy of growth hormone (GH) treatment in patients. Some studies indicate~     that high IGF-I levels are associated with increased cancer risk, and low IGF-I levels are~     associated with increased risk for cardiovascular disease. Studies in children also show that~     the serum IGF-I level is correlated with the change in height score achieved (that is, the~     higher the IGF-I level, the greater the gain in height). Pediatric endocrinologists have~     therefore begun to use serum IGF-I levels, in addition to growth rate and weight gain, to~     adjust the GH dose in treated children.~      Although monitoring of serum IGF-I levels is becoming standard of care in patients begin~     treated with GH, there are few guidelines regarding the actual logistics of adjusting GH~     dose. As serum IGF-I level has been linked to both safety and efficacy of GH treatment, the~     ideal practice would be to maintain serum IGF-I levels within a certain target range. The~     overall goal of our study is to construct a mathematical model which predicts the change in~     GH dose necessary to achieve a desired change in IGF-I level.~      Hypotheses to be tested by our study include the following: IGF-I measurement has a role in~     optimization of GH therapy; GH dose change to achieve IGF-I changes are predictable; and~     gender and puberty affect the relationship between dose change and target IGF-I changes.~   "
251241|NCT00263393|"~     This study will evaluate the effectiveness of a novel cardiovascular disease prevention~     program designed for delivery through existing primary health care services in rural villages~     in Andhra Pradesh.~      The primary aim is to increase the number of high-risk individuals in the population that are~     appropriately managed with proven, low-cost preventive interventions. The corresponding null~     hypothesis is therefore that the prevention program will result in no change in the~     proportion of high-risk individuals identified and treated in villages assigned to~     intervention compared with those villages assigned to control.~   "
251242|NCT00263380|"~     Research on the synergistic effect of corticosteroids and beta-agonists on the cytokine~     production in COPD patients. Blood will be obtained from healthy volunteers and COPD patients~     and blood monocytes will be stimulated to produce cytokines with or without the prementioned~     drugs.~   "
251243|NCT00263367|"~     This study will look at the changes taking place in the blood levels of key markers of~     oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes~     vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about~     changes at pressures slightly greater than normal atmospheric pressure.~      Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this~     study only for safety. It is not being assessed for the ability of hyperbaric oxygen to~     improve the clinical condition of children with autism.~      This study was felt to be important since autism appears to be associated with oxidative~     stress and hyperbarics was being used off-label for this condition without safety studies.~   "
251244|NCT00263354|"~     To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in~     patients with advanced unresectable or metastatic gastric cancer.~   "
251245|NCT00263341|"~     The purpose of this 1-year study is to evaluate the efficacy and safety of a new~     contraceptive vaginal ring (CVR) delivering low doses of Nestorone (NES), a new,~     nonandrogenic progestin, and ethinyl estradiol (EE), an estrogen used in oral contraceptives.~     The CVR, which is made of silicone rubber, is designed to be used for 1 year (13 menstrual~     cycles) before replacement is required.~   "
251246|NCT00263328|"~     A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune~     system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study~     A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months~     posttransplant. Patients who completed study A3921009 were offered the opportunity to~     participate in study A3921021 which will extend the evaluation of safety and efficacy of~     CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control~     arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects~     will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be~     discontinued.~   "
251247|NCT00263315|"~     A Phase II/III randomized double-blind study comparing the safety and the efficacy of a~     weekly administration of 25 mg nebulized AmBisome with nebulized placebo solution to prevent~     invasive pulmonary aspergillosis in neutropenic hemato-oncologic patients.~   "
251248|NCT00263302|"~     The purpose of this study is to determine whether glucocorticoids have potent diuretic~     effects in patients with congestive heart failure.~   "
251249|NCT00263289|"~     Nitrous oxide analgesia is used routinely for the dental treatment of anxious or~     uncooperative pediatric patients. In many instances it is used alone without any supplemental~     oral premedication. A controversy exists among pediatric dentists and pediatric dental~     departments regarding the need to apply pre-procedural fasting (PF) or other limitations on~     children undergoing dental treatment with nitrous oxide alone.The purpose of this study is to~     investigate the association between PF and the frequency of vomiting in pediatric patients~     receiving dental treatment with nitrous oxide analgesia.~   "
251250|NCT00263276|"~     The purpose of this clinical research study is to learn if BMS-512148 is effective in~     controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients~     who have been diagnosed with Type 2 diabetes. Patients should first try to control their~     diabetes with diet and exercise and should not have previously been treated for their~     diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be~     studied~   "
251251|NCT00263263|"~     Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in~     native coronary arteries reducing the occurrence of restenosis and repeated~     revascularization, however saphenous vein grafts have been always excluded form randomized~     trials.~      Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with~     respect to bare-metal-stents in degenerated vein grafts.~      Design: Double-blind randomized controlled non-industry-sponsored trial.~      Setting: A single-center tertiary-care referral hospital.~      Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the~     corresponding bare-metal-stent. All patients are followed clinically and repeated~     angiographic follow-up is performed in all at 6-months.~      Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss.~     Secondary end-points include: binary angiographic in-stent and in-segment restenosis,~     intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events~     (death, myocardial infarction, target-lesion and target-vessel revascularization).~   "
251252|NCT00263250|"~     This is a multicenter clinical trial to compare pain, physical function, and other outcomes~     in men with asymptomatic or minimally symptomatic inguinal hernias randomly assigned to~     watchful waiting without an operation, or a standard hernia repair with mesh. We studied the~     safety of delaying operation.~   "
251265|NCT00263068|"~     This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM~     936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal~     dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the~     Taper Period of SP792 are allowed to enroll in this trial.~      All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2~     patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments,~     initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of~     6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although~     not all subjects will require 28 days to reach their optimal dose.~      A subject's dose may be increased or decreased, as needed by the investigator to maintain a~     subject's effective dose during the Maintenance Period. A Taper Period is provided to allow~     for safe, gradual withdrawal from trial medication~   "
251253|NCT00263237|"~     This study will determine whether an experimental medicine, STA-5326 mesylate, is safe to use~     in patients with common variable immunodeficiency (CVID) who have inflammation of the gut. It~     will also determine if patients who take this drug show improvement in their symptoms,~     decrease in inflammatory chemicals in the gut, changes in their immune cells, and improvement~     in how their gut is functioning to absorb food.~      Patients between 18 and 75 years of age with CVID and chronic diarrhea or involuntary weight~     loss of more than 5 percent of their past body weight over the past 12 months may be eligible~     for this study. Candidates are screened with a review of their medical records, a medical~     history and physical examination, blood, urine and stool tests, chest x-rays and skin test~     for exposure to tuberculosis, and a hydrogen breath test. For the latter, breath samples are~     collected before and every 20 minutes (for 2 hours) after the subject drinks a sugar~     solution. This test determines the digestive effects of bacteria in the upper intestine.~     Samples are collected by having the subject blow into a balloon.~      Participants undergo the following tests and procedures:~      Immune System and Gastrointestinal Evaluation~        -  48-hour stool fat collection (measures the amount of undigested fat in the stool):~          Subjects keep a diary of what they eat for a 48-hour period. At the beginning of the 48~          hours they take two dye capsules and then take another two capsules 48 hours later. They~          collect a stool sample when they pass the second set of capsules in their bowel~          movement. An additional 24-hour stool collection is tested for loss of protein in the~          stool.~        -  D-xylose absorption test (measures the ability of the gut to absorb nutrients): Subjects~          drink a solution of d-xylose (a sugar substitute). Blood samples are collected before~          and 1 hour after drinking the solution.~        -  Upper endoscopy: A thin flexible lighted tube is advanced through the mouth to evaluate~          the esophagus, stomach and beginning of the small intestine.~        -  Lower endoscopy: A thin flexible lighted tube is advanced through the rectum to evaluate~          the colon.~      Treatment Period (Study days 1 to 57)~        -  Physical examination - study days 1, 8, 15, 29, 43 and 57~        -  Blood samples to test the levels of STA-5326 in the blood. On study days 1 and 57,~          samples are collected before the medication dose and 1, 2, 4, 6 and 8 hours after the~          dose; on day 29, one sample is collected before the medication dose.~        -  Blood samples for routine safety testing - study days 1, 8, 15, 29, 43 and 57~        -  Medication history - study days 1, 8, 15, 29, 43 and 57~        -  Interview about pain, discomfort, and well being - study days 1, 8, 15, 29, 43 and 57~        -  Pregnancy test for women who can become pregnant - study days 15, 43, and 57~        -  D-xylose absorption test - study days 29 and 57~        -  Electrocardiogram - study days 29 and 57~        -  Urine test - study days 29 and 57~        -  Blood test for research on immune cells - study day 57~        -  Repeat endoscopies and studies of gut function (24- and 48-hour stool collections)~      Follow-up period (Day 85 and day 113)~      -Physical examination, blood tests, medication history, questions about pain, discomfort and~     well being~   "
251254|NCT00263211|"~     The purpose of this study is to determine the effects of Plavix and aspirin in women with~     metastatic breast cancer.~   "
251255|NCT00263198|"~     The purpose of this study is to test the safety of PTK787/ZK222584 and Letrozole when given~     in combination, and to see what effects they have on breast cancer that has metastasized.~   "
251256|NCT00263185|"~     The purpose of this study is to determine whether Vitamin D supplementation reduces the~     symptoms of muscle stiffness and joint tenderness that some patients may develop after~     starting therapy with Anastrozole for breast cancer.~   "
251257|NCT00263172|"~     The primary purpose of this study was to compare weight loss achieved through a behavioral~     online intervention vs. a commercial self-help website. The investigators hypothesized that~     there would be no difference in weight loss between groups.~   "
251258|NCT00263159|"~     The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity~     of pharmaceutical care for asthma patients.~   "
251259|NCT00263146|"~     Acute Respiratory Distress Syndrom is associated to lung and systemic inflammation, which~     could be worsened by mechanical ventilation.This included a proteasis - antiproteasis~     imbalance which could participate to a fibrosis process.~      Low tidal-volume ventilation (6 mL/kg) with low plateau pressure (< 30 cm H2O) has been~     proved to decrease mortality when compared with more conventionnal high-volume (12 mL/kg)~     ventilation.Moreover, this lung-protective approach decrease lung annd systemic inflammation.~      Using recruitment maneuvers (i.e. the application during a short time of high pressures with~     the intention to re-open the lung, followed by an increase of PEEP-level to keep the lung~     open, in an attempt to decrease the alveolar shear-stress) has been proposed to improve~     oxygen and to reduce bio-trauma.~      However, the effect of such maneuvers on the inflammatory response and on the evolution of~     ARDS remains unknown.~      Therefore we have planned a randomized, monocentric, controlled trial consisting of the~     comparison of two approaches of mechanical ventilation in Acute Lung Injury. This trial will~     include 30 hemodynamically stable patients fulfilling the ALI or ARDS criteria defined by the~     US and European Consensus Conference.~      They will be randomized in two groups: standard low-volume ventilation vs. recruitment~     maneuvers.~      The main objective of our study is to compare both ventilatory strategies in termes of lung~     and systemic inflammation.~      The primary outcome measures will be the proteasis activity as measured in broncho alveolar~     fluid (BAL) and pro- and antiinflammatory cytokines activity as measured in the BAL and in~     the blood. Two samples (BAL and blood) will be obtained at a 48-72 hours interval. In the~     recruitment maneuver group, the first BAL will be obtained two hours before the maneuver.~      Secondary outcome measures will be gaz exchange, respiratory mechanics, systemic hemodynamics~     and visceral dysfunction scores.~   "
251260|NCT00263133|"~     12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks.~     Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and~     statistically compared. This study aims to examine a putative modulation of synaptic~     transmission and plasticity by an antidepressant and is part of a series of studies in~     healthy individuals and depressed patients.~   "
251261|NCT00263120|"~     The thymus is known to be the site of T cell development in humans. Due to its location in~     the chest in front of the heart, incidental thymecomy is commonly performed during~     cardiothoracic surgery, especially in infants and children, so that surgeons may gain access~     to the surgical field. This practice has been considered safe because it was thought that the~     thymus is inactive after birth. However, recent data using newly developed techniques has~     demonstrated that the thymus normally is active well into adulthood. In addition, in a~     previous study (UCLA IRB # 02-03-008-02) we have demonstrated alterations in lymphocyte (T~     cells) number in individuals who have undergone thymectomy in childhood but we do not know~     how immunity is affected. We plan to investigate if immune development or immune function~     later in life is affected by the loss of T cell production caused by thymectomy during~     cardiothoracic surgical procedures in childhood. At UCLA, a large number of patients are seen~     who have congenital heart disease and undergo surgical procedures for correction or repair~     and many children and adults are followed for many years after they have undergone surgical~     procedures. Subjects for study will be recruited from among these patients.~      We propose a study which will examine the number and activity of lymphocytes obtained from~     blood samples from child and young adult subjects who have undergone surgery in early~     childhood. We will determine if these subjects have had complete thymectomy in the past using~     CT or MRI (obtained during routine care) or, for subjects who are having cardiothoracic~     surgery, by visualization of thymic tissue during the procedure. In addition we will give~     vaccination for a common viral illness (hepatitis A) and measure immune responses to it (from~     a blood sample). As part of this study, we will ask for medical information consisting of a~     history of congenital cardiac disease and other diagnoses (such as asthma), a history of~     infections and hospitalizations, and information about immunizations. We will also ask about~     a list of specific symptoms which will give us information about the function of the immune~     system.~   "
251262|NCT00263107|"~     Telerounding is the use of wireless remote video-confrencing to assess hospitalized patients.~     Physicians thus rely on all ususal data collected during bedside rounds with the exeption of~     a direct physical exam. The intention of this study is to determine if post-operative~     morbidity can be identified in an accurate and timely manner.~   "
251263|NCT00263094|"~     Fasting is a known trigger for headache. People who fast to comply with religious edict have~     been shown to be prone to headache which becomes more likely to occur with increasing length~     of fasting, and in people prone to headache. This has been documented as 'Yom Kippur~     Headache' and 'First of Ramadan Headache.' We performed a study to test the hypothesis that~     Rofecoxib, a pain medicine and anti-inflammatory, with a prolonged duration of action would~     prevent or attenuate headache when taken just prior to the complete (no food or drink) 25~     hour fast of Yom Kippur.~   "
251264|NCT00263081|"~     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily~     (QD), to lower cholesterol in subjects with homozygous familial hypercholesterolemia~     undergoing lipid-lowering treatment.~   "
251267|NCT00263042|"~     The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI),~     stroke, or death from an MI or stroke in patients with abdominal obesity with other~     cardiovascular (CV) risk factors.~      The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV~     death, or CV hospitalization in these patients.~   "
251268|NCT00263029|"~     The purpose of this phase II trial is to determine the efficacy and safety of the combination~     of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced~     cancers of the rectum.~   "
251269|NCT00263016|"~     Primary Objective:~        -  To compare the tumour response rate of combination chemotherapy irinotecan/cisplatin~          (IC) versus docetaxel/cisplatin (DC) in advanced NSCLC patients who responded to 3~          courses of docetaxel/cisplatin.~      Secondary Objectives :~        -  To compare the time to progression after chemotherapy treatment between the IC and DC~          arms of treatment.~        -  To compare the toxicity profile of the IC and DC arms of treatment.~   "
251270|NCT00263003|"~     Study Objectives :~        -  To demonstrate the reduction in office Blood Pressure following a 8-week regimen of~          irbesartan / hydrochlorothiazide using irbesartan as a reference.~        -  To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan~          / hydrochlorothiazide using irbesartan as a reference.~        -  To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood~          Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week~          regimen of irbesartan / hydrochlorothiazide versus irbesartan.~        -  To compare the proportion of patients requiring titration after 4-week regimen of~          irbesartan/hydrochlorothiazide versus irbesartan~        -  To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus~          irbesartan when administered once daily~   "
251271|NCT00262990|"~     The objective of this study is to assess the safety and efficacy of patupilone compared to~     pegylated liposomal doxorubicin. Additionally, this study will assess the ability of~     patupilone to extend the survival time and potential beneficial effects in women who have~     nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.~   "
251272|NCT00262977|"~     Our aim is to determine if a patient-directed intervention is more effective than~     computerized clinician reminders alone for improving aspirin use in adults with diabetes.~   "
251273|NCT00262964|"~     The primary goal of this study is to provide a better understanding of: 1) the pathogenesis~     and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2)~     the effect of marked weight loss on the histologic and metabolic abnormalities associated~     with NAFLD. The following hypotheses will be tested:~        1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat~          tissue and increased free fatty acid availability,~        2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar)~          production by the liver and altered liver protein synthesis,~        3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic~          inflammation, necrosis and fibrosis, and~        4. marked weight loss improves NAFLD once patients are weight stable.~   "
251274|NCT00262951|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Interferon alfa may interfere~     with the growth of tumor cells. Giving combination chemotherapy and radiation therapy~     together with interferon alfa before surgery may shrink the tumor so it can be removed.~     Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy and~     radiation therapy together with interferon alfa works in treating patients with locally~     advanced pancreatic cancer that cannot be removed by surgery.~   "
251275|NCT00262938|"~     RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of~     life of obese endometrial cancer patients and may help them live longer and more comfortably.~      PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary~     counseling on weight loss and quality of life of obese patients with stage I or stage II~     endometrial cancer in remission.~   "
251276|NCT00262925|"~     This phase II trial is studying how well giving combination chemotherapy together with~     alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic~     leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as~     alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer~     cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Giving combination chemotherapy together with alemtuzumab may kill more~     cancer cells.~   "
251277|NCT00262899|"~     RATIONALE: Genetics education and counseling may help patients make treatment decisions. It~     is not yet known how genetic counseling or usual care influence patient treatment decisions~     for breast cancer.~      PURPOSE: This randomized clinical trial is studying how well genetic counseling works~     compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ,~     stage I, stage II, or stage IIIA breast cancer make treatment decisions.~   "
251278|NCT00262886|"~     RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or~     sister may be an effective treatment for kidney cancer.~      PURPOSE: This phase II trial is studying how well a donor peripheral stem cell or bone marrow~     transplant works in treating patients with relapsed or refractory metastatic kidney cancer.~   "
251279|NCT00262873|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with~     myelodysplastic syndromes.~   "
251280|NCT00262860|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may~     kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine~     hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.~   "
251281|NCT00262847|"~     This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how~     well they work compared to carboplatin, paclitaxel, and placebo in treating patients with~     stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs~     used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to~     grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are~     more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial,~     primary peritoneal, or fallopian tube cancer.~   "
251282|NCT00262834|"~     This phase II trial is studying how well vorinostat works in treating women who are~     undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer.~     Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.~   "
251283|NCT00262821|"~     This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to~     see how well they work compared to cisplatin and radiation therapy in treating patients with~     cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Internal~     radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.~     Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is~     not yet known whether giving cisplatin together with radiation therapy is more effective with~     or without tirapazamine in treating cervical cancer.~   "
251284|NCT00262808|"~     RATIONALE: Colony-stimulating factors, such as GM-CSF, may increase the number of immune~     cells found in bone marrow or peripheral blood and may help the immune system recover from~     the side effects of chemotherapy or kill tumor cells. Drugs used in chemotherapy, such as~     fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy~     after surgery may kill any remaining tumor cells. Sometimes, after surgery, the tumor may not~     need additional treatment until it progresses. In this case, observation may be sufficient.~      PURPOSE: This phase II trial is studying how well GM-CSF and combination chemotherapy work in~     treating patients who are undergoing surgery for stage II or stage III colon cancer.~   "
251285|NCT00262795|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. It is not yet known whether fludarabine is more effective than~     chlorambucil in treating chronic lymphocytic leukemia.~      PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as~     first-line therapy compared to chlorambucil in treating older patients with previously~     untreated chronic lymphocytic leukemia.~   "
251286|NCT00262782|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Sometimes, the cancer may not need treatment until it progresses. In this case, observation~     may be sufficient. It is not yet known whether fludarabine is more effective than observation~     in treating chronic lymphocytic leukemia.~      PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works~     compared to observation only in treating patients with stage 0, stage I, or stage II B-cell~     chronic lymphocytic leukemia.~   "
251287|NCT00262769|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It~     is not yet known whether gemcitabine is more effective with or without cisplatin in treating~     cholangiocarcinoma or biliary tract tumors.~      PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how~     well they work compared to gemcitabine alone in treating patients with unresectable locally~     advanced or metastatic cholangiocarcinoma or other biliary tract tumors.~   "
251288|NCT00262743|"~     RATIONALE: Green tea extract contains ingredients that may slow the growth of certain~     cancers.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of green tea~     extract and to see how well it works in treating patients with stage 0, stage I, or stage II~     chronic lymphocytic leukemia (CLL).~   "
251289|NCT00262730|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Biological therapies, such as~     poly ICLC, may stimulate the immune system in different ways and stop tumor cells from~     growing. Giving poly ICLC after radiation therapy and temozolomide may stop any remaining~     tumor cells from growing.~      PURPOSE: This phase II trial is studying how well giving radiation therapy together with~     temozolomide followed by temozolomide and poly ICLC works in treating patients with newly~     diagnosed glioblastoma multiforme.~   "
251290|NCT00262717|"~     To compare two commercially available platforms for assessment of HIV drug resistance to~     determine which provides superior virological results.~      We hypothesise that one test will be significantly superior to the other.~   "
251291|NCT00262704|"~     This randomized trial will test the hypotheses that (a) a physician opinion leader~     intervention, (b) a narrative process trace physician feedback intervention, or (c) the~     combined intervention (a + b), are no more effective than (d) usual care in improving the~     clinical care of adult patients with type 2 diabetes.~   "
251292|NCT00262691|"~     Cardiovascular disease is a complex multifactorial and polygenic disorder that is thought to~     result from an interaction between a person's genetic make up and various environmental~     factors. Although many studies have revealed that several genetic variants increase the risk~     of cardiovascular disease, the results of these studies remain controversial. The purpose of~     this study is to identify polymorphisms that confer susceptibility to cardiovascular disease~     and to clarify the adequacy of reported susceptibility gene polymorphisms. To complete this~     purpose, we will prospectively study over 5,000 local residents in whom relationship between~     these polymorphisms and occurrence of cardiovascular disease over 5 years.~   "
251295|NCT00262652|"~     Sodium pyruvate in sodium chloride solution will be delivered by nebulization to the lungs.~     It is believed that this administration will produce bronchodilation in asthmatics as~     determined by improvement in FEV1. FEV1 is a measure of lung function, and will be determined~     after administration of sodium pyruvate. The study is a blinded, so subjects may receive~     either the sodium pyruvate or a sodium chloride placebo. The primary endpoint will be the~     improvement of FEV1 after 15 minutes in subjects receiving sodium pyruvate compared to the~     FEV1 of subjects receiving the sodium chloride placebo.~   "
251296|NCT00262639|"~     This is a placebo controlled trial (some people receive active and some people receive~     inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol~     dependence. Two main medications (plus ancillary non-placebo controlled medications) and~     their placebos (inactive drugs) will be utilized to treat both alcohol withdrawal, promote~     abstinence, and reduce drinking over approximately a six-week treatment period. All~     participants will meet criteria for Alcohol Dependence and be drinking heavily up until 72~     hours prior to receiving the first study drug. They will be injected one drug (flumazenil or~     placebo) over a two day period and receive the second one (gabapentin or placebo) by mouth~     for 39 days. The main hypothesis is that this protocol will reduce early alcohol withdrawal~     symptoms and will reduce relapse to drinking and promote abstinence compared to the placebo~     (inactive) drug group. Secondary outcomes that will be evaluated include reduction in~     craving, improvement in sleep, brain activity and mood.~   "
251297|NCT00262626|"~     Glaucoma is a disease which affects between one and two percent of all individuals aged over~     40 years. According to recent Canadian National Institute for the Blind figures, it is the~     second largest specific cause of blindness in this country. The most common form of glaucoma,~     open-angle glaucoma, is incipient and typically results in a progressive loss of vision~     without symptoms due to damage to a structure inside the eye called the optic nerve head.~     Although the most important known risk factor for the development of open-angle glaucoma is~     high intraocular pressure (the pressure within the eyeball), a number of researchers have~     shown that a sizeable proportion of patients continue to lose vision in spite of successful~     treatment to lower their intraocular pressure. This finding suggests that there may be~     additional risk factors involved. Ocular vasospasm (the inability of certain blood vessels to~     dilate and increase blood flow according to the needs the eye) and vascular disease are among~     other factors implicated but their roles have not yet been fully investigated. The Canadian~     Glaucoma Study Group proposes to investigate the role of risk factors, including vasospasm~     and vascular disease, involved in the progression of open-angle glaucoma. We will recruit 410~     patients with open-angle glaucoma across 4 centres (Halifax, Vancouver, Montreal and Toronto)~     who will be treated by experienced investigative ophthalmologists according to a uniform~     standard protocol to ensure that all patients are managed in the same manner. The patients~     will be followed meticulously with the most modern and accurate tests available every four~     months for a period of 5 years to determine whether progression has taken place. Visual~     function will be measured using two techniques called conventional perimetry and~     blue-on-yellow perimetry, and optic nerve heads will be examined with a special scanner~     capable of three-dimensional imaging. By defining both the ocular and systemic profiles of~     patients who progress and do not progress, we may be able to identify which patients will~     benefit from the standard treatment of intraocular pressure reduction, such as that~     prescribed in the study. More importantly, we will identify the characteristics of patients~     who do not benefit from standard treatment, so that alternative ones may be developed. Such~     studies are clearly necessary, but have not yet been conducted. We believe that the proposed~     study will increase our knowledge of open-angle glaucoma and reduce its impact on blindness~     and visual disability.~   "
251298|NCT00262613|"~     In animal models, sodium pyruvate has been shown to be an effective anti-inflammatory agent,~     and in human studies sodium pyruvate has been shown to be a bronchodilating agent. Subjects~     with COPD are known to have inflammation in the lung, and often have bronchoconstriction. As~     such, these subjects typically are on multiple therapies, including steroid therapy. This~     trial will study the effect of inhaled sodium pyruvate on inflammation and lung function in~     COPD subjects over a six week period.~   "
251299|NCT00262600|"~     The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran~     etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and~     systemic embolism.~   "
251300|NCT00262587|"~     International studies have shown that elite athletes have a high prevalence of respiratory~     symptoms and asthma as compared to normal subjects. It is unclear whether the increased~     prevalence of asthma in elite athletes reflects traditional asthma or whether it is a~     special form of sports asthma. The treatment of elite athletes with asthma seems to vary~     widely, and only a few studies have focused on the treatment of elite athletes with asthma.~     Further knowledge of the pathogenesis of sports asthma would lead to a greater understanding~     and better treatment of the condition. This study will investigate the type of airway~     inflammation in elite athletes and examine the effect of treatment with inhaled steroids in~     combination with long-acting beta-agonists versus placebo in the same group.~   "
251301|NCT00262574|"~     Patients receiving BNP or nitroglycerin (IV) during the angioplasty procedure. 24 h after the~     procedure, vascular reactivity will be re-examined using the brachial artery flow-mediated~     dilatation study. Blood assays for ET-1, pro-BNP, and various inflammatory markers will be~     checked before and 24 h after the procedure. It is our hypothesis that endothelial function~     will be better in the BNP treated patients compared to the NTG treated patients~   "
251302|NCT00262561|"~     263 patients with peripheral atherosclerosis were examined to evaluate the activity of the~     platelets during the standard treatment, including aspirin. A subgroup of 43 received 600 mg~     of clopidogrel 2 h before platelet reactivity analysis.~      The main hypothesis is that high platelet activity at the beginning of the study is~     associated with a higher risk of atherothrombosis. Follow up time is 5 years.~   "
251303|NCT00262548|"~     The purpose of this study is to determine whether treatment with rosuvastatin for 6 months in~     obese type 2 diabetic women will improve their lipid profiles and thus prevent the~     progression to cardiovascular disease.~   "
251304|NCT00262522|"~     The purpose of this study was to compare the safety and tolerability of the to-be-marketed~     lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC)~     formulation and to compare the safety, tolerability, and antiviral activity of once daily~     (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select~     nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously~     received antiretroviral treatment.~   "
251305|NCT00262509|"~     The purpose of the research project is to develop and evaluate an emergency egress system for~     persons with visual impairment, which would use existing lighted exit signage to provide~     egress information at a distance of up to 100 feet.~   "
251344|NCT00262002|"~     The purpose of this study is to evaluate the safety, immunogenicity and induction of immune~     memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate~     Vaccine administered to healthy infants.~   "
251306|NCT00262496|"~     The purpose of the study is to determine whether Botulinum-A toxin injected in the bladder~     muscle will help prevent the frequency and degree of urinary incontinence in Spinal Cord~     Injured and Multiple Sclerosis patients. The proposed mechanism would be that the Toxin would~     allow the bladder to hold more urine at a lower pressure as determined by Urodynamics. The~     research will answer the question whether the dosages 300 units vs 400 units are either~     equally vs not equally effective in helping urinary incontinece and bladder storage.~   "
251307|NCT00262483|"~     To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with~     hepatitis C.~   "
251308|NCT00262470|"~     This trial is designed to study the effects of various mechanistically unique medications in~     controlling excessive increases in heart rate with standing and in improving the symptoms of~     orthostatic intolerance in patients with this disorder.~   "
251309|NCT00262457|"~     The purpose of this study was to determine the feasibility of an implanted electrical~     stimulation system incorporating BION microstimulators for long term use to prevent tissue~     breakdown in high risk patients.~   "
251310|NCT00262444|"~     Evaluation of the difference in pressure ulcer incidence or the time to develop pressure~     ulcers depending on the turning frequencies.~   "
251311|NCT00262431|"~     The study aims to assess early (one to three days after intubation) tracheostomy~     effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.~   "
251312|NCT00262418|"~     Comparison of the efficacy and safety of a single administration of ivermectin to a single~     administration of permethrin for the treatment of scabies~   "
251313|NCT00262405|"~     Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic~     pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and~     physiologic assessment at baseline. Subjects will be monitored off treatment for three months~     for changes in symptoms and physiology. Subjects will then be randomized to six months of~     treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is~     change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment.~     Secondary endpoints are progression free survival, change in dyspnea, change in quality of~     life, and change in physiology.~   "
251314|NCT00262392|"~     The purpose of this study is to determine whether Bisphosphonates in comparison to radiation~     therapy are effective in the prophylaxis and treatment of heterotopic ossification in high~     risk patients.~   "
251315|NCT00262379|"~     The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with~     peginterferon plus ribavirin.~   "
251316|NCT00262366|"~     Comparison of automatic CPAP with fixed CPAP in patients with OSAS~   "
251317|NCT00262353|"~     Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial~     hepatic system~   "
251318|NCT00262340|"~     The purpose of this study is to determine whether using non-invasive measurements of airway~     inflammation can improve clinical decision making in children with severe asthma compared to~     conventional management (British Thoracic Society Guidelines)~   "
251319|NCT00262327|"~     The growth and metastasis of solid tumors are dependent on angiogenesis. Endostatin, the~     C-terminal proteolytic fragment of collagen XVIII, is an effective endogenous angiogenesis~     inhibitor in cancer therapy in mice. Applied for clinical studies in solid tumor, however,~     recombinant human endostatin protein, difficulties in a large-scale production of the~     recombinant endostatin protein, and the cumbersome daily administration. Up to now, its~     clinical application has been hampered by those matters. We herein constructed a adenoviral~     vector ecoding human endostatin. This study will test the safety and efficacy of recombinant~     human endostatin adenovirus (Ad-rhE) in the treatment of patients with advanced solid tumors.~   "
251320|NCT00262314|"~     The overall objective of this study is to collect data relevant to the tolerability of~     Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring~     recommendations specified in the package insert.~   "
251321|NCT00262301|"~     Hereditary angioedema (HAE) is a genetic disorder characterized by sudden recurrent attacks~     of local swelling (angioedema). These attacks are often painful and disabling, and, in some~     cases, life-threatening. HAE is caused by mutations in the C1INH gene that leads to a~     decrease in the blood level of functional C1INH. This multi-center study was designed to~     assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of~     recombinant human C1 inhibitor (rhC1INH) in the treatment of acute hereditary angioedema~     attacks.~   "
251322|NCT00262288|"~     The purpose of this multi-center study is to explore the efficacy, safety, tolerability and~     pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute~     attacks in patients with hereditary angioedema.~   "
251323|NCT00262275|"~     To investigate the effect of different dosages of aspirin on platelet aggregation and to~     determine the possible mechanisms of aspirin resistance, we intend to compare the effects of~     low, medium dose aspirin with clopidogrel (an alternative antiplatelet agent) in patients~     after coronary artery bypass surgery.~   "
251324|NCT00262262|"~     The aim of this study is determine whether or not the antiepileptic drug Levetiracetam is an~     effective treatment of the postmastectomy pain syndrome.~   "
251325|NCT00262249|"~     This trial is conducted in the United States of America (USA). The purpose of the trial is to~     compare the effect of Norditropin® using different dosing regimens in children suspected of~     growth hormone deficiency.~   "
251326|NCT00262236|"~     This is a study for people diagnosed with hypertension to compare the safety and~     effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in~     the study for 12 weeks.~   "
251327|NCT00262223|"~     This treatment intervention trial is designed for men and women with either alcohol misuse~     (e.g. hazardous or binge drinking) or alcohol use disorders (alcohol abuse or dependence) and~     comorbid PTSD. Participants will be randomly assigned to one of two treatments (a cognitive~     behavioral treatment intervention called Seeking Safety + Medication (Zoloft) or Seeking~     Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12~     sessions over 12 weeks), and again at 6 months and 12 months post-treatment.~   "
252121|NCT00251654|"~     The investigators prospectively document infectious, neurological, and other complications or~     adverse events occurring during peripheral regional anesthesia via a catheter using~     computer-based data recording.~   "
251328|NCT00262210|"~     * AIMS OF THE STUDY~        1. To test if steroid-free chemotherapeutic regimens decrease the risk of HBV reactivation~          and hepatitis development in HBsAg (+) carriers.~        2. To compare the efficacy of steroid-free chemotherapeutic regimens with that of~          steroid-containing regimens in terms of lymphoma control.~        3. To study the change of activity of HBV and other hepatotropic viruses during the course~          of chemotherapy.~   "
251329|NCT00262197|"~     This project evaluates a HPMG effort to reduce error rates through customized direct feedback~     of diabetes quality of care data to diabetes patients and their physicians. HPMG has~     routinely provided patients with personalized feedback of glucose and cholesterol test~     results since about 1997. This project will implement and evaluate the impact of this~     intervention on diabetes medical error rates and resource use.~   "
251330|NCT00262184|"~     Consumption of soy-based foods is associated with a number of health benefits, including~     lower risk of cardiovascular disease, breast and prostate cancer, attenuated menopausal~     symptoms and prevention of bone loss with age.~      In order to investigate the effect of isoflavone on bone mineral density (BMD) and in Taiwan~     women with postmenopausal osteopenia, a Taiwan Isoflavone Multicentric Enrollment Study~     (TIMS) is designed.~   "
251331|NCT00262171|"~     The purpose of this study is to establish the HNPCC related information in Taiwan, and to~     characterize relevant susceptibility genes related to colorectal cancer to provide better~     disease control for the high-risk people. To accomplish this objective, we will collect~     detailed information of the HNPCC patients and their families from the collaborative~     hospitals and relate the information to the risk of CRC in order to provide sound disease~     control system in Taiwan.~   "
251332|NCT00262158|"~     This project is the survey on smoking behavior in Taiwan. The survey information will be used~     to analyze the influence of the earmarked tax of cigarettes on (1)the consumption of~     cigarette,(2)the substitution between the consumption of domestic and imported cigarettes,~     and(3)the consumption of other addictive goods.~   "
251333|NCT00262145|"~     Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to~     reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and~     carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by~     the intestinal mucosa). There has been some study of the ability of these products to reduce~     the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol~     levels in chronic studies. The purpose of the present study is to objectively determine if~     one cup of “tea” made from a combination of three types of tea leaves (mulberry, black and~     green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea.~      Research Design - The study will consist of a double blind, placebo controlled crossover~     study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a~     standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of~     white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will~     also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting~     of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon.~     On one of the test days the subjects (randomly) will concurrently consume the active~     preparation, a tea containing extracts of the three types of tea leave described above plus~     the meal, and on the other test day they will consume the meal with a liquid placebo~     preparation (warm water, sugar and food coloring). Subjects will provide a breath sample~     before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate~     malabsorption will be determined by the hydrogen concentration in the breath samples and fat~     malabsorption by the concentration of 13-CO2 in the breath samples.~      Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption~     and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract~     actually induces carbohydrate and/or fat malabsorption could provide the basis for further~     studies.~   "
251334|NCT00262132|"~     Corticosteroids are presently the drug of choice for the treatment of pulmonary sarcoidosis.~     However, corticosteroids are associated with many significant side effects. For this reason,~     it would be beneficial to find an alternative agent to corticosteroids for the treatment of~     pulmonary sarcoidosis. This study is an open label trial of mycophenolate for new onset~     pulmonary sarcoidosis. Patients are candidates for this study if they have biopsy proven~     pulmonary sarcoidosis and a vital capacity or FEV1 less than 80% of predicted. Patients must~     undergo bronchoscopy where not only is the diagnosis of pulmonary sarcoidosis required, but~     in addition, cells are obtained from bronchoalveolar lavage. If the patients are diagnosed~     with pulmonary sarcoidosis, they are placed on an initial dose of 500mg BID of mycophenolate~     for 1 week. If their blood counts are not affected on this dose and they have no significant~     symptoms that are thought to be drug related, then their dose is escalated to 1g BID for the~     remaining 9 weeks of the study (the total study drug therapy time is 10 weeks). The patients~     are followed with multiple study visits. At these visits blood tests are drawn to make sure~     that there are no significant side effects from mycophenolate. In addition, the patients have~     a history and physical performed to evaluate the clinical state of their sarcoidosis and to~     detect mycophenolate side effects. On completion of 10 weeks of mycophenolate therapy, the~     patients undergo a second bronchoscopy with bronchoalveolar lavage to obtain cells for~     analysis. The patients are evaluated with spirometry, measurements of shortness of breath~     (dyspnea), and a quality of life scale (SF36) at serial visits during their study. The~     primary endpoint of the study is improved, unchanged or worse FVC. It is hoped that this~     pilot study will suggest that mycophenolate is a reasonable treatment option for new onset~     pulmonary sarcoidosis.~   "
251335|NCT00262119|"~     The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and~     atrial preventive and antitachycardia pacing therapies on the reduction of a composite~     clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular~     hospitalizations.~   "
251336|NCT00262106|"~     The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5~     gels compared to placebo in preventing vaginally acquired HIV infection.~   "
251337|NCT00262093|"~     The reason for having a higher incidence of preeclampsia in primiparas may involve~     angiogenesis imbalance in these patients.~   "
251338|NCT00262080|"~     The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an~     investigational product) is safe and relieves symptoms of HAE in patients suffering from~     moderate to severe acute attacks of HAE.~   "
251339|NCT00262067|"~     This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate~     the efficacy and safety of bevacizumab in combination with chemotherapy compared with~     chemotherapy alone in subjects with previously untreated metastatic breast cancer.~   "
251340|NCT00262054|"~     The purpose of this study is to determine whether bivalirudin given during PCI is associated~     with better outcomes compared to un-fractionated heparin.~   "
251341|NCT00262041|"~     The purpose of this study is to evaluate the safety and immunogenicity of Novartis~     Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide~     vaccine administered to healthy adolescents ages 11 to 17 years.~   "
251342|NCT00262028|"~     The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly~     Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10~     years~   "
251343|NCT00262015|"~     The purpose of this study is to determine when a memory immune response after re-vaccination~     with Meningococcal C conjugate vaccine (Menjugate) or challenge with Meningococcal A/C~     polysaccharide vaccine can be observed, after initial vaccination with Meningococcal C~     conjugate vaccine during the UK immunization campaign~   "
251345|NCT00261989|"~     The aim of this study is to describe the presenting pulse oximetry reading in patients who~     have a known lesion which will cause them to have a low presenting oximetry reading. The~     study hypothesis is that there is a low presenting pulse oximetry in patients with congenital~     heart disease and that there will be no significant variation in the hourly variation in~     oximetry readings in these patients.~   "
251346|NCT00261976|"~     This is a study evaluating the long-term safety of infliximab (Remicade)~   "
251347|NCT00261963|"~     The purpose of this study is to examine the effect of UV-irradiation on human cutaneous~     cicatrices by clinical examinations and histological, immunohistochemical and biochemical~     analyses.~   "
251348|NCT00261950|"~     The purpose of this study is to evaluate the effects of cinacalcet on markers of bone~     turnover in patients with kidney disease who are receiving dialysis.~   "
251349|NCT00261937|"~     We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute~     bronchiolitis.~   "
251350|NCT00261924|"~     Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7~     days are safe and effective compared to platelets collected by the same method, stored for~     the same amount of time and not treated for pathogen inactivation.~   "
251351|NCT00261911|"~     The purpose of this study is to assess the effectiveness of sibutramine on weight loss,~     reduction in body size and improvement in metabolic risk factors and safety in obese~     adolescents.~   "
251352|NCT00261898|"~     OBJECTIVE: Obesity and chronic sleep deprivation have both become increasingly pervasive~     medical problems in recent years. The prevalence of adult obesity has doubled over the past~     30 years and continues to increase. In addition, industrial societies attach an economic~     value to maximizing the waking period to the longest tolerable limit by sleeping as little as~     possible. Average sleep time has decreased over the last century by 2 hours. Chronically~     sleeping less has been associated with increased weight, endocrine and metabolic health risks~     including glucose intolerance, cardiovascular disease, and mortality. The possibility that~     the current epidemic of obesity and metabolic health risks may be partially related to~     insufficient sleep is now being recognized. The objective of this proof-of-concept controlled~     trial is to investigate the impact of increasing sleep time in chronically sleep-deprived,~     obese subjects.~      STUDY POPULATION: 18-50 year old, obese (BMI 30-50) men and premenopausal women, chronically~     sleep deprived, recruited from the Baltimore-Washington metropolitan area. Chronic sleep~     deprivation will be verified by the use of sleep logs and the use of actigraphy before entry~     into the study. Secondary causes of sleep deprivation such as insomnia, psychological~     (depression), and medical conditions associated with poor sleep quality (including~     obstructive sleep apnea) will be exclusionary criteria.~      DESIGN: This is a randomized, 12-month duration, comparison-controlled clinical trial of an~     extension of sleep up to approximately 7 hours and 30 minutes (Intervention Group) or~     continuation of habitual short sleep schedule (Comparison Group). The proposed treatment is~     an educational and behavioral intervention aimed at increasing sleep in a non-pharmacological~     fashion. The main analysis of the study will be to determine if additional sleep will result~     in a significant difference in body weight at the end of 12 months between the Intervention~     Group and the Comparison Group. In addition, we would like to establish whether 12 months of~     additional sleep will result in: a) a decreased prevalence of metabolic syndrome; and b)~     changes in the endocrine profile (i.e. inducing changes in leptin [increase] and ghrelin~     [decrease] opposite to the changes associated with chronic sleep deprivation). At the end of~     the 12-month intervention study (Phase 1, Efficacy Randomized Phase Study), all participants~     will be given information about the potential benefit of more sleep and encouraged to~     increase sleep time. Health teaching about proper nutrition and adequate exercise will also~     be provided at that time to the Intervention and Comparison Groups. All participants will be~     evaluated 6 months later to assess the effects of this intervention in a real-life situation,~     and offered participation in a three-year extension with semi-annual visits (Phase 2,~     Effectiveness 3 Year Follow-Up Phase Study), for which matched external comparison subjects~     will also be recruited ad hoc.~      OUTCOME PARAMETERS: body weight, average number of hours of sleep/night, fasting glucose and~     insulin, oral glucose tolerance test, leptin, ghrelin, adiponectin, other relevant endocrine~     and anthropometric measures, body composition, various metabolic parameters, food intake,~     energy expenditure, and quality of life measures.~   "
251353|NCT00261872|"~     This study of persons with both alcoholism and ADHD will determine whether adding the drug~     methylphenidate to a standard treatment program will decrease alcohol use. In approximately~     half of patients with ADHD, symptoms persist into adulthood, and the untreated condition is~     associated with a significantly increased incidence of substance use disorder. Also, more~     than one-third of adults with substance use disorder have symptoms of ADHD. This study will~     evaluate the effectiveness of adding methylphenidate to a standard alcohol treatment program~     in improving patients' treatment compliance and decreasing adverse consequences of drinking,~     as well as monitoring their attention deficit/hyperactivity symptoms,~      People 21 to 65 years of age with alcoholism and attention deficit hyperactivity disorder~     (ADHD) may be eligible for this study.~      Participants are randomly assigned to receive either slow-release methylphenidate (an~     approved medication for ADHD) or placebo. All subjects participate in NIAAA's alcohol~     treatment program, which includes a standardized 12-week behavioral therapy course and~     treatment with naltrexone, a medication to prevent relapse. Patients are assessed once a week~     with the standard NIAAA treatment evaluation battery, including:~        -  Timeline Followback: A validated self-report method to assess a person's drinking over a~          defined interval in time~        -  Addiction Severity Index: A validated interview that measures problem severity in seven~          areas related to drug and alcohol abuse~        -  Biomarkers for alcohol abuse~        -  Conners Adult ADHD Rating Scale (a rating scale for ADHD symptoms and severity)~   "
251354|NCT00261859|"~     The purpose of this study is to evaluate the effectiveness of an enhanced emergency~     practitioner (EP) performed brief intervention (BI), namely, the Enhanced Brief Negotiation~     Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary~     care provider, followed by a telephone booster intervention performed by trained nurses~     1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and~     standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled~     clinical trial 900 hazardous and harmful (HH) drinkers will be randomly assigned to one of~     the 4 conditions. We, the researchers at Yale University, will conduct cost benefit analysis~     of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via~     interactive voice response (IVR).~   "
251355|NCT00261846|"~     This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606~     (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation~     study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum~     tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of~     Part 1 and after a dose has been established for the compound in chronic phase subjects. Part~     2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all~     phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the~     hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic~     Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in~     advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.~   "
251356|NCT00261833|"~     This is a randomized, placebo-controlled, double-blind, multicenter phase III/IV study to~     compare the efficacy and safety of Zemaira® with placebo in subjects with emphysema due to~     alpha1-proteinase inhibitor deficiency. The effect of Zemaira® on the progression of~     emphysema will be assessed by the decline of lung density, measured by computed tomography~     (CT).~   "
251357|NCT00261820|"~     Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12~     months after transplantation in patients receiving either a regimen of sirolimus plus~     mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining~     tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients~     undergoing renal allograft transplantation. In addition, the two treatment groups will be~     compared with respect to the incidence of acute rejection at 3, 6 and 12 months following~     transplantation, and the patient and graft survival at 6 and 12 months after transplantation.~     The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will~     be evaluated beginning in the immediate post-operative period.~   "
251372|NCT00261612|"~     Mantle cell lymphoma (MCL) remains difficult to treat by standard treatment approaches. Novel~     drugs have shown promising results in early clinical evaluations. In the current trial, we~     investigate a combination of bortezomib (a proteasome inhibitor), rituximab (a monoclonal~     antibody), and dexamethasone in patients with MCL, who have already been pretreated by~     standard chemotherapy and show again signs of disease progression. The study objectives~     include remission rates, safety of this drug combination, and survival time.~   "
251418|NCT00261014|"~     The purpose of this study is to develop a way to predict which patients diagnosed with~     idiopathic blood clots can safely stop warfarin therapy after six months. We will use patient~     characteristics, blood test results and imaging test results to identify those patients who~     have the lowest risk of developing a new blood clot after warfarin is stopped.~   "
251358|NCT00261807|"~     Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive~     cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI)~     with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior~     to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did~     not include any patients with clostridial infection, there is in vitro data to support the~     activity of daptomycin against a variety of clostridial species(11) ( Clostridium~     perfringens) Therefore, for this trial we will include patients with clostridial infections~     with this species. Additionally, the patients in the SSTI study were not as ill as the~     proposed study population. Therefore for treatment of such severe infections, we would like~     to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of~     daptomycin in this subgroup are as follows:~        1. Patients who are severely ill have an increased volume of distribution; and therefore~          have a lower serum concentration of daptomycin. These patients might require a higher~          dose of daptomycin to achieve the desired serum concentration.~        2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and~          faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the~          drug to achieve adequate free (unbound) serum concentration of the drug.~        3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The~          clinical trials for endocarditis are using 6mg/kg/dose of daptomycin.~      Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should~     use the higher dose of daptomycin.~      Objective:~      To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin~     therapy in the treatment of patients with severe necrotizing skin and soft tissue infections.~      Type of Study:~      Open label, single center study.~   "
251359|NCT00261794|"~     The purpose of this study is to evaluate the efficacy of an innovative, computer driven~     cognitive rehabilitation program for unemployed veterans with schizophrenia.~   "
251360|NCT00261781|"~     The major aim of this study is to determine the efficacy of a home-based treadmill walking~     program in improving walking capacity and quality of life in people with early mid-stage~     Parkinson's disease(PD).~   "
251361|NCT00261768|"~     The purpose of this study is to see if noise reduction programs in digital hearing aids help~     patients hear better than hearing aids without these programs. We also want to know if we can~     predict how successful patients will be with hearing aids.~   "
251362|NCT00261755|"~     The purpose of this study is to investigate the effect of acupuncture for pain relief and~     relaxation during childbirth.~   "
251363|NCT00261742|"~     The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin~     for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of~     age) with perianal dermatitis caused by group A beta-hemolytic streptococci.~   "
251364|NCT00261729|"~     Evaluate the efficacy and tolerability of the drug prazosin compared to placebo for combat~     stress-related nightmares, sleep disturbance and overall function in recently combat-exposed~     returnees from OIF and OEF. To evaluate the effects of the SSRI paroxetine on behavioral~     symptoms and overall function in this population.~   "
251365|NCT00261716|"~     Many persons with schizophrenia have difficulty getting and keeping a job. This study is~     designed to compare the benefits of four sessions of motivational interviewing or illness~     education in increasing employment rates accruing from participation in supported employment.~   "
251366|NCT00261703|"~     Primary Objective:~        -  Phase II: To determine the best treatment scheme (TPF vs. PF).~        -  Phase III: To compare the time to progression and the treatment failure at the 3 arms.~      Secondary objectives:~        -  To evaluate the safety at the 3 arms.~        -  To compare the progression , overall survival and locoregional control at the 3 arms.~   "
251367|NCT00261690|"~     Using Virtual Reality as a form of Distraction during Burn Care.~   "
251368|NCT00261677|"~     The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing~     of PROCRITÂ® (a glycoprotein that stimulates red blood cell production) versus placebo in the~     treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect~     on the quality of life.~   "
251369|NCT00261664|"~     Telehomecare is a technology that individuals use in their homes to communicate with health~     providers electronically. This technology can help them function at a higher level and avoid~     undesirable hospitalizations by making changes in their everyday behaviors, but research is~     needed to understand how telehomecare supports health behavior change and leads to improved~     health status.~      The hypothesis being tested is that the use of an electronic method of monitoring and~     transmitting health information facilitates patient empowerment, with subsequent effects on~     the patient's ability to manage her/his treatment regimen more effectively. The study will~     explore the relationship between telehomecare and acquisition of knowledge, and will show~     whether changes in knowledge levels translate to changes in behaviors and improved health~     outcomes. The effects of two different telehomecare systems (nurse-directed vs.~     patient-directed) on knowledge, self-management, and health status will be compared. A~     further goal is to illuminate the attitudes of physicians regarding the use of telehomecare~     in the treatment of their elderly, community dwelling patients.~      Results will inform managers and policymakers who are responsible for integrating eHealth~     mechanisms into chronic disease protocols, funding health care programs, and creating~     policies that support the use of information technology by all Americans.~   "
251370|NCT00261638|"~     “Health” includes physical and mental aspects. The evaluation of “Mental Health” contains~     four domains: psychophysical health, perceived security of the living world, meaning and~     worth of life, satisfaction of family-social interaction.~      We have established a Taiwan Mental Health Index scale based on literature review and~     experts’ opinions in 2002. The reliability and validity were assessed to be satisfactory.~     This TMHI scale has been applied in nation-wide mental health surveys of 2002, 2003, and~     2004.~      In order to evaluate the effect of mental health promotion activities, this research project~     will adopt this TMHI scale as the assessment tool. 300 people will be recruited for study~     after signing the informed consent. The general population sample of 1076 subjects recruited~     in 2004, will be as the comparison sample. The difference in 4 dimensions of MHI will be~     analyzed between these two study groups. The 300 study subjects will be subcategorized into~     two groups of low and high attendance groups. The difference in MHI between groups will also~     be statistically examined using independent t-test. The statistical signification is set at~     α=0.05.~      This study result will be as the reference for setting up effective mental health promotion~     program for general public.~   "
251371|NCT00261625|"~     Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women.~     However, its safety and efficacy in increasing bone mineral density in chronic peritoneal~     dialysis (PD) patients have not been investigated. Etidronate, another bisphosphonate, can~     suppress the extent of coronary artery calcification in chronic hemodialysis patients. The~     hypothesis of this study is that alendronate can increase bone mineral density and suppress~     aortic and coronary artery calcification in chronic peritoneal dialysis patients.~   "
251373|NCT00261599|"~     Very often patients receive medication before a diagnostic procedure, like a colonoscopy, to~     help them relax and stay calm during the procedure. This is called procedural or~     minimal-to-moderate sedation. One product used for sedation is called propofol. AQUAVAN~     (fospropofol disodium) is made as a water soluble form of propofol allowing for rapid~     sedation during the entire procedure. This study is designed to test AQUAVAN for sedation~     during colonoscopy procedures.~   "
251374|NCT00261586|"~     The purpose of this study is to compare several analgesics given in approved daily doses in~     combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding~     properties and their effects on the stomach in healthy volunteers.~   "
251375|NCT00261573|"~     The purpose of this study is to evaluate the safety and efficacy of galantamine (a drug for~     treating dementia) compared to placebo in the treatment of patients with dementia related to~     cerebrovascular disease (vascular dementia) or dementia related to Alzheimer's disease with~     cerebrovascular disease (mixed dementia).~   "
251376|NCT00261560|"~     The purpose of this study is to compare the safety and effectiveness of 1300 mg acetaminophen~     extended release given three times daily for nine days to that of 400 mg ibuprofen given~     three times daily for nine days for the signs and symptoms of (Grade I and Grade II) lateral~     ankle sprains.~   "
251377|NCT00261547|"~     The purpose of this study is to determine if administration of rituximab blocks the~     development of donor specific antibodies (DSA) in transplant recipients who have developed~     renal dysfunction and DSA after renal transplant. It is hoped that by blocking DSA production~     renal function will stabilize or improve.~   "
251378|NCT00261534|"~     The purpose of this study is to examine the degree of fatigue in patients receiving~     chemotherapy. Special interest goes out to the course of fatigue throughout five treatments~     and the actions taken by patients to reduce this fatigue.The correlation between fatigue and~     haemoglobin will also be subject of study.~   "
251379|NCT00261521|"~     The purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to~     assess the effect of correction versus partial correction of anemia using epoetin alfa on~     heart pumping function.~   "
251380|NCT00261508|"~     The purpose of the study is to evaluate the effectiveness of an oral solution of risperidone~     (an antipsychotic medication) versus placebo in the treatment of behavioral symptoms in~     children with Pervasive Developmental Disorders (PDD).~   "
251381|NCT00261495|"~     The purpose of this study is to compare the effectiveness and safety of sustained- release~     hydromorphone, formulated to release slowly over time, taken once daily, and controlled-~     release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will~     also determine the dose of sustained-release hydromorphone that provides a level of pain~     control that is equal to the pain control provided by control-released oxycodone~     (equi-analgesic dosage).~   "
251382|NCT00261482|"~     The purpose of the study is to evaluate user experience with the EVRAÂ® Contraceptive~     Transdermal Patch; specifically, user satisfaction with the EVRAÂ® Patch, and if applicable,~     user preference of the EVRAÂ® Patch compared with the previous method of contraception. The~     study also evaluates contraceptive efficacy, safety and user compliance.~   "
251383|NCT00261469|"~     The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative~     use before a migraine attack) enhances the effectiveness of migraine treatment with triptans.~   "
251384|NCT00261456|"~     The IMPACT study is an international targeted prostate screening study of men at increased~     prostate cancer risk due to the presence of known pathogenic mutations in BRCA1 and BRCA2~     genes.~      There are only approximately 150 men with a known BRCA1 or BRCA2 mutation in the UK. Research~     has shown that these men are at an increased risk of developing prostate cancer but more~     information is needed about the pathogenesis of prostate cancer in this defined group and the~     role of screening in these men. The study will offer annual PSA screening to these men to~     determine the incidence of prostate cancer in this group. The study will also look at new~     markers of early prostate cancer in this cohort.~      The power calculations for this study are 850 carriers and 850 controls (age-matched men~     without BRCA1/2 mutations). It is therefore essential to gain international collaboration to~     meet the target of recruiting 850 men with these known mutations and a control group of 850~     men who have tested negative for a known familial mutation.~   "
251385|NCT00261443|"~     The purpose of this clinical research study is to learn if outpatients with bipolar mania who~     are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms~     on a combination treatment of aripiprazole plus lithium or valproate.~   "
251386|NCT00261430|"~     The purpose of this study is to examine treatment practices of adult schizophrenia patients~     by their own doctors, and to assess patient outcomes when treated with long-acting~     risperidone injection over a two-year period of observation.~   "
251387|NCT00261417|"~     This is a 12-week study to determine the effect on glucose and lipids, safety, and~     tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo~     in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study~     comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double~     blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week~     follow-up.~   "
251388|NCT00261404|"~     Phase II, open label study in which patients with metastatic melanoma (stage III or IV) who~     have cancer which is not considered curable by surgery will receive intratumoral injections~     of TNFerade™ plus radiation as a 4-week treatment, followed by a 3 year follow-up period.~   "
251389|NCT00261391|"~     3 patients were enrolled in each of 3 study cohorts. There three cohorts were given~     differing, incrementally larger doses of this phase I drug. The same safety measures are~     being obtained on all patients. Efficacy measures were individualized as enrolllees do not~     have the same underlying vascular anomaly. The study is structured to include a 24 month~     drug-phase and a 24 month follow-up phase. The study is now closed to enrollment.~   "
251390|NCT00261378|"~     The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by~     intra-arterial embolisation for the treatment of Hepatocellular Carcinoma~   "
251391|NCT00261365|"~     The purpose of this study is to identify candidate markers predictive of response and/or~     serious toxicity to BMS-734016 (MDX-010).~   "
251404|NCT00261196|"~     The purpose of this study is to test collagenase injection therapy to dissolve adhesions~     causing frozen shoulder.~   "
251392|NCT00261352|"~     This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of~     tesaglitazar compared with metformin and metformin in combination with fenofibrate in~     patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C).~     Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment~     period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center,~     active controlled (metformin with or without fenofibrate) treatment period and a 3-week~     follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin~     (rosuvastatin)~   "
251393|NCT00261339|"~     Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and~     esophagus. GERD occurs when the lower esophageal sphincter does not close properly and~     stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common~     medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. Proton~     pump inhibitors such as pantoprazole, can relieve symptoms of GERD in a large proportion of~     patients.~      Of particular interest in GERD is the assessment of symptom severity and quality of life, and~     the response to treatment. Therefore, a questionnaire was developed to assess GERD symptoms~     (`ReQuest TradeMark in Practice`). An important point to consider when using such a~     questionnaire is to follow the patients´ medical response to treatment and note whether a~     patient needs to change dosing, such as changing from full dose to half dose, or vice versa.~      The aim of the study is to determine the value of the questionnaire (`ReQuest TradeMark in~     Practice`) according to treating physicians` clinical judgment when using pantoprazole at~     full and half dose. The study duration consists of a pre-treatment periods (0-2 weeks) and~     two treatment period (8 weeks each). During the first treatment period, pantoprazole will be~     administered once daily at full dose (40 mg). During the second treatment period,~     pantoprazole will be administered once daily at half dose (20 mg). The study will provide~     further data on safety and tolerability of pantoprazole.~   "
251394|NCT00261326|"~     The purpose of this study is to investigate if the simvastatin treatment improve the visual~     function after 3 months of the inclusion to this project and if the simvastatin influences~     the results on cerebral MRI after 3 and 6 months of the inclusion. In addition the~     development of new demyelinating relapses. In the patients with monosymptomatic acut optic~     neuritis to investigate whether the simvastatin reduces the risk to develop multiple~     sclerosis (MS).~   "
251395|NCT00261313|"~     This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel~     (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast~     cancer setting.~   "
251396|NCT00261300|"~     Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and~     esophagus. GERD might occur when the lower esophageal sphincter does not close properly and~     stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common~     medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of~     the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach~     touches the lining of the esophagus, causing a burning sensation in the chest or throat.~     Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in~     a large proportion of patients.~      Additionally, long-term treatment with proton pump inhibitors may be needed for patients with~     chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which~     is often associated with ulcers in the stomach or duodenum).~      The aim of the study is to evaluate the long-term effect of pantoprazole in patients with~     chronic gastric acid-related complaints. The study duration consists of a 5-year treatment~     period. Pantoprazole will be administered once daily. The study will provide further data on~     long-term safety, tolerability, and efficacy of pantoprazole.~   "
251397|NCT00261287|"~     The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal~     spray for long term use in relieving symptoms in perennial allergic rhinitis.~   "
251398|NCT00261274|"~     The purpose of this study is to demonstrate that small amounts of a person's own red cells,~     when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused,~     repeatedly. Each participant will have some blood drawn, treated with an enzyme, washed and~     re-infused five times. Additional samples of blood will be drawn for testing and evaluation.~   "
251399|NCT00261261|"~     Children experience significant anxiety and distress during the preoperative period.~     Currently available interventions are ineffective and/or associated with significant~     disadvantages. These interventions exclusively target the child and do not attempt to reduce~     parental anxiety. Based on an integration of the literature in both the anesthesia and~     psychological milieus, we developed ADVANCE, a behaviorally oriented anxiety reduction~     program for children undergoing surgery that targets the family as a whole.~   "
251400|NCT00261248|"~     The purpose of this study is determine whether a vaginal mucosal vaccine given to women with~     a history of recurrent urinary tract infections can reduce the number of infections occurring~     in a six-month study period, as compared to placebo treatment.~   "
251401|NCT00261235|"~     The purpose of this study is to test the effectiveness of USES, a strengths-based enhancement~     to supported employment (SE), as compared to supported employment alone.~   "
251402|NCT00261222|"~     Design: Single-centre~      Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the~     efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural~     and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN).~      Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary~     temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health~     centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital~     outpatient department.~      Sample size: N=120~      Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three~     days (first and second day: 10mg/kg, third day: 5mg/kg).~      Statistical procedures: The primary analysis parameter is the proportion of clinical failures~     on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without~     PCR correction), the rate of early clinical failures, the rate of late parasitological~     failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the~     overall group of study children and for rural (n=50) and urban (n=50) study children~     separately.~      Study duration and dates: The study will be implemented in September-December 2005.~   "
251403|NCT00261209|"~     The purpose of this study is to dissolve flexor tendon adhesions associated with failed~     tendon repair surgery.~   "
251405|NCT00261183|"~     We hypothesized that patient will success in benzodiazepine withdrawal if they get melatonin~     to solve sleep-problems which commonly occur during benzodiazepine withdrawal. Former heroin~     addicts, currently in Methadone maintenance treatment, who are also abusing benzodiazepine,~     started self benzodiazepine withdrawal, and got for 6 weeks melatonin (5mg/day, taken every~     night) or placebo and after 1 week, additional 6 weeks with placebo or melatonin (double~     blind for what got first).Success The benzodiazepine withdrawal success was evaluated by~     urine for benzodiazepines, and sleep quality was evaluated using PSQI questionnaire~     (baseline,and after weeks 6, 7, 13)~   "
251406|NCT00261170|"~     This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned~     to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely~     to have quit smoking at the end of treatment and at 6 months compared with smokers randomly~     assigned to receive placebo and cognitive-behavioral counseling. Because depression is more~     prevalent among smokers and because smokers who are prone to depression may become depressed~     when they quit, the hypothesis is that the proportion of quitters who receive the active~     drug/antidepressant will be greater than the proportion of quitters who receive the placebo~     drug at 6 months.~   "
251407|NCT00261157|"~     This research is being done to test a two-way video system mounted on top of a robot. After~     surgery the act of seeing and evaluating patients in the hospital is called standard~     rounding. This research study will allow doctors to see and speak with their patients using~     the two-way video system - telerounding, during their stay at the hospital. The purpose of~     this study is to assess the safety of telerounding during a patients hospital stay.~      Our hypothesis is that post-operative morbidity and the time to identification of~     post-operative morbidity will not vary with this new method of rounding.~   "
251408|NCT00261144|"~     The purpose of this study is to determine if collagenase injection will reduce or eliminate~     the appearance of cellulite of the thigh.~   "
251409|NCT00261131|"~     The study proposes to determine if injections of BTX-A to the hamstring muscles result in~     measurable physiologic changes not observed with normal saline injections in children with~     spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern.~   "
251410|NCT00261118|"~     There is broad support for the hypothesis that Ulcerative colitis is an auto-immune disease.~     Rituximab is an antibody protein that removes a subgroup of white blood cells (B lymphocytes)~     from the circulation. These cells have the capacity to generate the auto-antibodies that~     typify auto-immune disease. Although Rituximab has been mainly used for treating B lymphocyte~     malignancies (lymphoma) it has also been used with promising results in Rheumatoid arthritis~     and has an excellent safety record. This is a small placebo-controlled trial to assess its~     efficacy and safety in patients with steroid-resistant active ulcerative colitis.~   "
251411|NCT00261105|"~     Primary Objectives:~        -  The primary objective of the study is to evaluate clinical efficacy i.e. to show that~          with respect to clinical cure rate, Ketek® (telithromycin) in the treatment of community~          acquired respiratory tract infections: community acquired pneumonia (CAP), acute~          bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in~          outpatients.~      Secondary Objectives:~      The secondary objectives are to:~        -  Further assess the efficacy of Ketek® (telithromycin) by considering the rate at which~          additional antibacterials were prescribed to treat the primary infection; the rate of~          hospitalisation due to a complication of the primary infection and assessment of~          bacteriological data, chest X-ray and sinus X-ray if available.~        -  Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse~          Event (SAE) reporting~   "
251412|NCT00261092|"~     Primary objective:~        -  To evaluate overall response rate (based on RECIST criterion)~      Secondary objective:~        -  To evaluate time to progression, clinical benefit, quality of life and safety~   "
251413|NCT00261079|"~     Primary objective:~        -  To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus~          prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin~          disease~      Secondary objective:~        -  To evaluate patient's satisfaction of Allegra treatment~   "
251414|NCT00261066|"~     By investigating the long-term functional status of patients who have undergone various types~     of orthopaedic surgery we will have a basis for devising guidelines for future patients and~     surgeons.~   "
251415|NCT00261053|"~     The purpose of this single-center study is to explore the efficacy, safety, tolerability and~     pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute~     attacks in patients with hereditary angioedema.~   "
251416|NCT00261040|"~     The purpose of this study is to determine if there is a difference in terms of length of~     hospital stay and post-operative outcomes between patients whose total hip replacement~     surgery is performed with a minimally invasive versus standard surgical approach.~   "
251417|NCT00261027|"~     This project is a pilot, phase II, open-label, single-center, non-comparative clinical study~     evaluating the antitumor efficacy and tolerability of exemestane in treating adult~     post-menopausal women with recurrent or refractory, stage II-IV, epithelial ovarian cancer.~      To evaluate the efficacy and tolerability of exemestane in this population, patients will be~     enrolled at a single site, namely the Ottawa Regional Cancer Center. Patients selected~     according to the criteria outlined will receive exemestane (25 mg/day given orally once~     daily) until disease progression or until study withdrawal. These patients will be treated on~     an out-patient basis. There is no specific wash-out time required for patients who have~     previously received either cis or carboplatinum; however, this previous therapy must stop~     upon patient inclusion into this trial.~      In 1st stage if less than 2/15 patients achieve a response then study will be terminated. In~     2nd stage if greater than 7/28 patients achieve a response then no further investigation of~     the drug is warranted.Treatment (including drug dosages) A commercial supply of exemestane~     (Aromasin) will be provided. The medication will be administered by the patient at home (25~     mg taken orally once daily until disease progression) The medication should be taken each day~     after a meal at the same time of the day. There are no patient diaries and no need for the~     patient to record the time of administration.~   "
251444|NCT00260663|"~     This study compares the effectiveness of hearing aid appointments provided in a group format~     to those provided in an individual format. We are asking if hearing aid training with group~     appointments is as good as or better than with individual appointments.~   "
251419|NCT00261001|"~     The rationale for transcutaneous vaccination is based on the unique ability of cutaneous~     immune cells, especially Langerhans cells (LCs), to present antigens to the immune system.~     DCs can be found at high densities in the epidermis and the dermis of human skin, a fraction~     of which are the epidermal LCs. It is known that strong and efficient immune responses can be~     induced by targeting vaccines to skin APCs (Glenn 2003, Partidos 2003), e.g. by epicutaneous~     application of smallpox vaccine on scarified skin. Several obstacles however prevent vaccines~     from attaining sufficiently high and free concentrations in these target skin DCs.~      In this clinical trial we aim at testing the safety and immunogenicity of this new~     transcutaneous route of vaccine administration, first with a licensed, well-known, safe and~     highly immunogenic vaccine i.e. Tetagrip® vaccine, which is licensed for subcutaneous (s.c.)~     and intra-muscular routes (i.m), and to compare the induced vaccine-specific immune responses~     to those induced with the conventional (i.m) injection. We hypothesize that the~     transcutaneous application of Tetagrip® in the commercially available standard preparation of~     0.5 ml should be capable to induce at least similar antibody and CD4 and/or CD8 T cell~     responses to both the tetanus and the flu vaccinal antigens.~      This Phase I, open label, randomized study is designed to evaluate and to compare the safety~     and immunogenicity of a transcutaneous mode of Tetanus / Influenza vaccination to the~     conventional i.m. route of vaccine administration in two cohorts: The cohort I constituted of~     healthy volunteers and the cohort II of HIV-infected patients in whom the virus is stably~     controlled by antiretroviral therapy, ensuring an immune competence and a capacity to respond~     to vaccines.~   "
251420|NCT00260988|"~     The purpose of this study is to better understand if either dalteparin or tinzaparin is a~     better drug to use in dialysis patients on blood thinners who are at high risk of developing~     blood clots and need surgery.~   "
251421|NCT00260975|"~     Many breast cancer patients treated with chemotherapy complain of problems with concentration~     and memory. This has been referred to as chemo fog. The current study is investigating this~     phenomenon by measuring mental function of breast cancer patients prior to and after exposure~     to chemotherapy, and by comparing mental function in those patients who receive chemotherapy~     and those who do not.~   "
251422|NCT00260962|"~     The purpose of the study is to evaluate the efficacy of an anti-psychotic medication,~     Olanzapine, in achieving desired weight gain in patients identified as having Anorexia~     Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible~     beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety~     symptoms associated with this disorder.~   "
251423|NCT00260949|"~     There are two ways in which surgeons repair rotator cuff tears. An open method involves~     making an incision (cut) 5-6 inches in length in the skin and repairing the tear with the~     skin open, while the arthroscopic method involves making small holes in the skin and using a~     guiding camera and special equipment to repair the tear. This clinical study is being~     conducted to study the rate of re-tear (one year following surgery) of rotator cuffs that~     have been repaired using the arthroscopic technique.~   "
251424|NCT00260936|"~     To assess whether there exist significant differences in glucose metabolism, lipids, lactate,~     body composition, and bone density between HIV-infected and uninfected young men.~   "
251425|NCT00260923|"~     This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and~     300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in~     the study for 8 weeks~   "
251426|NCT00260910|"~     The purpose of this study is to determine the progression evaluation and genetic~     determinations of hypertension in Chinese~   "
251427|NCT00260897|"~     Avascular necrosis of the femoral head (ANFH) is a debilitating disease that commonly leads~     to destruction of the hip joint in patients at middle age of life and often requires surgical~     intervention. Previously, we have identified the collagen type II, alpha 1 (COL2A1) gene as~     the ANFH disease gene. In this grant proposal, we will establish cell ine and animal models~     to understand the pathophysiology of ANFH, and extend our ongoing study for identifying genes~     responsible for non-familiar ANFH by looking into other interacting molecules of the pathway.~   "
251428|NCT00260884|"~     -  OBJECTIVES To determine in a prospective randomized clinical trial, the effect of~          extended lymph node dissection (R3 gastrectomy) versus conventional surgery (R0/1~          gastrectomy) on tumor recurrence and survival in Chinese patients with advanced cancer~          of the stomach (adenocarcinoma invasion beyond submucosa).~        -  STATISTICAL CONSIDERATIONS The major end points are disease free survival and survival.~          The log-rank test will be used as analytic method on disease-free survival and overall~          durvival. The follow-up time after treatment is five years.~      Previous experience provides an estimation of a 20% 5-year survival rate with conventional~     surgery for gastric cancer. Assuming that this new treatment (radical surgery) may increase~     the 5-year survival rate to 40%, we estimate that 118 evaluable patients are required to~     detected a significance at a of 0.05 level and power of 0.8 using a one tailed test.~      We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.~   "
251429|NCT00260871|"~     Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and~     environmental factors. In this grant proposal, we propose to map the loci of susceptibility~     genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus~     on a unique pathological type of a unique population in order to reduce heterogeneity of the~     genetic background. Compared with western women, female Chinese population has a high~     prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type,~     which has a familial basis, we will increase the probability of identifying genes associated~     with female lung adenocarcinoma. The primary goal of this study is to identify the genetic~     and environmental determinants of female lung adenocarcinoma, and study the relationship~     between gene polymorphisms and clinical manifestation profiling of lung cancer.~   "
251430|NCT00260858|"~     The purpose of this study is to assess the extent of and sources of variation in the~     glycaemic index values of foods measured by different laboratories around the world.~   "
251431|NCT00260832|"~     The purpose of this study is to compare the results in older patients who have newly~     diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine~     or patient's choice with the physician's advice of either cytarabine or supportive care~     medication.~   "
251432|NCT00260819|"~     Excessive rise in pulmonary artery pressure induced by low oxygen tension (hypoxia) is one of~     the factors implicated in high-altitude pulmonary oedema. Plasma ET1 increases in subjects~     exposed to high altitude and is correlated to pulmonary artery pressure.~      The aim of the study is to investigate whether blockade of ET1 receptors would reduce the~     acute rise in systolic pulmonary artery pressure induced by hypoxia.~   "
251433|NCT00260806|"~     This study will use the NIH-sponsored Women and Infants Transmission Study (WITS) and the~     Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection~     (P2C2) HIV-infected pediatric cohorts to determine how left ventricular (LV) function~     (particularly fractional shortening and contractility) and structure (particularly wall~     thickness and mass) are affected by cumulative intensity of exposure to highly active~     anti-retroviral therapy (HAART).~   "
251434|NCT00260793|"~     The purpose of this research study is to see if subjects with Parkinson's disease who are~     experiencing motor fluctuations (on and off states) and dyskinesias (involuntary~     excessive movements) would benefit from a higher dose of Requip as compared to the maximum~     FDA approved dose of dopamine agonist drugs (including Requip, Mirapex, and Permax). Requip~     as used in this study is investigational, which means it has not been approved by the US Food~     and Drug Administration (FDA) at this dose level.~   "
251435|NCT00260780|"~     Study participants who are exposed to the intervention will: 1)report more condom use during~     sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk~     reduction, communication, and anger management skills; 4) report fewer substance use~     behaviors, and 5)report more health care seeking activities, than the participants in the~     control group~   "
251436|NCT00260767|"~     This study will assess the distribution of topical gel in the human vagina, using enhanced~     MRI techniques. The number and size of uncovered areas will be studied, and the upper genital~     tract will be examined for the presence of topical gel using MRI.~   "
251437|NCT00260754|"~     Community members within the treatment city will report: 1)engaging in fewer sexual risk~     practices; 2)significantly higher condom use; 3) significantly higher rates of STD care~     seeking (including STD screening behaviors); 4) fewer having STDs in the past 6 months; 5)~     significantly higher awareness scores regarding syphilis and other STDs, as compared with~     those in the comparison city.~   "
251438|NCT00260741|"~     The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral~     cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe~     and effective in reducing the symptoms of spasticity and tremor in patients with~     secondary-progressive or primary progressive multiple sclerosis.~   "
251439|NCT00260728|"~     The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of~     the Fusion™ Vascular Access Graft for patients in need of early vascular access for~     hemodialysis.~   "
251440|NCT00260715|"~     After exposure to the C-POL intervention: 1) unprotected vaginal or anal sex, sex with casual~     partners, concurrent sexual relationships, and exchange of sex for drugs or money will~     decrease significantly; 2) perceived syphilis-risk for self and peer group, knowledge about~     highly relevant risk-factors, information sources and resources will increase significantly;~     and 3) syphilis morbidity will decrease significantly in the intervention community as~     compared to the comparison community.~   "
251441|NCT00260702|"~     This study will evaluate the safety and effectiveness of a laboratory-made antibody called~     omalizumab in patients with Job's syndrome, or hyper-IgE syndrome (HIES). Patients with HIES~     have very high levels of IgE antibody, a protein made by white blood cells. IgE plays an~     important role in starting allergic reactions in the body and may be related to some HIES~     symptoms, such as skin rashes and asthma. Patients also have frequent lung infections, easily~     broken bones and other symptoms. Omalizumab, which is approved to treat allergic asthma, is~     directed against IgE. This study will see if blocking IgE with omalizumab in HIES patients is~     safe and if it can reduce patients' IgE count. It will also look at how the body handles~     omalizumab and how it affects patients' symptoms.~      Patients 6 years of age or older with HIES may be eligible for this study. Each candidate is~     screened with a medical history, physical examination, skin examination and blood test.~      Participants receive an injection of omalizumab under the skin once every 2 weeks for 6~     doses. At the time of each injection, patients are examined by a doctor, answer questions~     about their symptoms and have a blood sample drawn. After the sixth dose, patients have a~     physical examination, blood tests, skin examination and lung function tests. At follow-up~     visits scheduled 2, 4 and 6 months after the last dose of omalizumab, patients have a~     physical examination, answer questions about their symptoms, and have a blood sample drawn.~     Patients who show a significant response to omalizumab stay off the drug for 3 months after~     the last dose and then discuss with their study doctor and referring doctor about continuing~     the medicine.~   "
251442|NCT00260689|"~     Severe aplastic anemia (SAA) is a life-threatening bone marrow failure disorder characterized~     by pancytopenia and a hypocellular bone marrow. Allogeneic bone marrow transplantation offers~     the opportunity for cure in 70% of patients, but most patients are not suitable candidates~     for hematopoietic stem cell transplantation (HSCT) due to advanced age or lack of a~     histocompatible donor. For these patients, comparable long term survival is attainable with~     immunosuppressive treatment with anti-thymocyte globulin (ATG) and cyclosporine (CsA).~     However, of those patients treated with horse ATG(h-ATG)/CsA, one quarter to one third will~     not respond, and about 50% of responders relapse. Auto-reactive T cells may be resistant to~     the effect of ATG/CsA (non-responders), while in others residual auto-reactive T cells expand~     post-treatment, leading to hematopoietic stem cell destruction and recurrent pancytopenia~     (relapse). As long term survival is correlated to response rates and robustness of~     hematopoietic recovery, novel immunosuppressive regimens that can achieve hematologic~     response and decrease relapse rates are needed.~      This trial will compare the effectiveness of three immunosuppressive regimens as first line~     therapies in patients with SAA with early hematologic response as the primary endpoint, as~     well as assess the role of extended CsA treatment after h-ATG in reducing numbers of late~     events of relapse and clonal evolution. Randomization is employed to obtain an equal~     distribution of subject to each arm; comparisons of early hematologic responses will be made~     among the rates observed among the three concurrent arms (rabbit-ATG [r-ATG] versus standard~     h-ATG; alemtuzumab vs standard h-ATG). For long course CSA, comparison of primary end points~     will be to well established historic relapse rate of 38% at 2-3 years and a cumulative rate~     of clonal evolution of 15%.~   "
251443|NCT00260676|"~     The aim of the study is to verify if a PROTECTIVE ventilatory strategy (low tidal volume~     and high PEEP, application of CPAP during the apnea test and recruitment maneuvers), improves~     lung function and increases the number of lungs eligible for transplantation.~   "
252136|NCT00251459|"~     This is a Phase IIIb, single-masked, 1-year multicenter study of the safety and tolerability~     of intravitreally administered ranibizumab in subjects with active subfoveal CNV secondary to~     AMD.~   "
251445|NCT00260650|"~     The purpose of this study was to determine the efficacy of a self-management program, called~     the Heart PACT Program, compared to usual health care in patients with heart failure.~     Outcomes measured were patient activation (skills needed to maintain function, collaborate~     with providers, and access care), self-care management, hospitalizations and emergency~     department visits.~   "
251446|NCT00260637|"~     Limited evidence suggests that acupuncture may help relieve symptoms of chronic~     prostatitis/chronic pelvic pain syndrome. This study evaluated if acupuncture twice weekly~     for 10 weeks would help ameliorate symptoms of CP/CPPS.~   "
251447|NCT00260624|"~     The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro)~     using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing~     agitation.~   "
251448|NCT00260611|"~     The primary objective for this study is to evaluate PSA response rates (response will be~     defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy. The~     secondary objectives are to compare progression free survival, disease free survival, overall~     survival, and toxicity (tolerance/safety).~   "
251449|NCT00260598|"~     The purpose of the study is to evaluate the usefulness and accuracy of the LIFE-Lung~     Bronchoscopy to identify early changes in lung tissues that show precancerous, cancer in~     situ (just beginning and not spread) and microscopic invasive cancer lesions versus the~     ability of the standard White Light Bronchoscopy to identify the same. This will be done as~     a part of routine monitoring bronchoscopy.~      Patients who have had a surgical resection of non-small cell lung cancer (NSCLC) and with no~     current evidence of disease (NED) will be eligible. Also eligible are patients who have had~     head or neck squamous cell carcinoma with radical head and/or neck dissection and who are~     currently NED. Patients with severe chronic, obstructive, pulmonary disease shown by~     pulmonary function testing abnormalities will also be eligible.~      In addition to the specialized bronchoscopy, doctors will be investigating the use of imaging~     spectroscopy. This is using an optical (visualizing) procedure to measure the light reflected~     back from tissue. Different lesions and normal tissues reflect light differently and in~     specific color wavelengths. By using measurements over time (different~     examinations/bronchoscopies) very small changes can be seen. This may allow eventually for~     very early diagnosing of precancerous or cancer in situ lesions, allowing for earlier~     treatment.~   "
251450|NCT00260585|"~     The purpose of this study is to identify markers in the blood and tissue that could indicate~     risk factors for the development and progression of esophagus cancer. This research aims to~     collect medical history, blood, and tissue samples from patients who present with an~     esophageal disorder. Identifying genetic and behavioral risk factors involved in the~     development of esophageal cancer might allow for early detection and prevention. Survival and~     an opportunity for a cure with esophageal cancer will depend greatly on the stage of~     diagnosis. Tumors can develop changes in their genetic (hereditary) make-up, and these~     changes can sometimes be seen in normal tissues before the development of cancer. These~     genetic (hereditary) changes can serve as tumor markers and can be detected using methods~     that study changes in genetic material like DNA and RNA. The analysis of proteins can provide~     additional information. By identifying changes in these molecules that are different or~     altered in cancer, the investigators can use methods and tests for the detection of these~     changes.~   "
251451|NCT00260572|"~     The aims of this study are to create a prospective data base to evaluate the long term~     outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to~     measure standard outcomes as well as patient derived outcomes such as general and disease~     specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that~     may identify patients who will benefit from surgery for GERD; and to identify possible~     determinants of failure of both medical and surgical treatments of reflux.~   "
251452|NCT00260559|"~     To assess short and long term outcomes after minimally invasive esophagectomy compared to~     open esophagectomy. To compare both standard outcome measures as well as patient derived~     outcome measures, in particular, quality of life (QOL). To look at the applicability of this~     QOL instrument to this patient group.~   "
251453|NCT00260546|"~     Cardiac resynchronisation therapy (CRT) is a highly effective treatment option for patients~     with symptomatic heart failure and electrical intraventricular dyssynchrony, who are~     unresponsive to medical therapy. CRT has been shown to improve the quality of life in these~     patients and lately two studies had shown a mortality reduction with and without the adjunct~     of an implantable cardioverter defibrillator (ICD). Unfortunately, up to 25% of the CRT~     recipients do not show a symptomatic improvement after device implantation (non-responder).~     Because of possible intermittent tachycardiac intrinsic conduction, it remains difficult in~     numerous patients to assure a 100% biventricular stimulation as the prerequisite for a~     beneficial therapeutic effect. In a important study by Knight et al it could be shown that in~     a population of 440 CRT-patients, 36% did not have continuous biventricular stimulation. The~     main cause was the occurrence of atrial tachyarrhythmias, in particular atrial fibrillation.~     The medical control of rapid ventricular conduction remains a difficult problem in heart~     failure patients. Furthermore it is unknown how many patients have good biventricular pacing~     under resting conditions but develop an improved AV-conduction with exercise. This can cause~     inhibition of ventricular stimulation or in many cases fusion beats. Conversely, an~     AV-interval programmed too short may have detrimental effects on diastolic filling times.~      The safest method to control the ventricular rate and prevent ventricular fusion beats with a~     normal AV time is the AV node ablation using radiofrequency ablation.~      The An Art Study investigates whether patients with an implanted CRT pacemaker or a CRT~     defibrillator will benefit from an AV-node-ablation using a combined symptomatic heart~     failure endpoint and duration of biventricular stimulation as compared to a CRT control~     group.~   "
251454|NCT00260533|"~     The purpose of this study is to determine the effectiveness and tolerability of atomoxetine~     (Strattera) in adult patients with generalized social anxiety disorder (an anxiety disorder~     characterized by a fear of interpersonal interactions).~   "
251455|NCT00260520|"~     The objective of this trial will be to determine whether prophylactic low-molecular weight~     heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A~     prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe~     fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal~     growth restriction, or both.~   "
251456|NCT00260494|"~     The purpose of this study is to determine if acupuncture improves wound healing. Since we,~     the investigators at the University of California, San Francisco (UCSF), know that how much~     oxygen is delivered to tissue is the best predictor of how well a wound will heal, we are~     measuring changes in tissue oxygen of wounds before and after acupuncture treatments. We are~     focusing on the leg wounds of coronary artery bypass graft (CABG) patients who have their~     saphenous veins harvested in an open fashion since this is a fairly well controlled patient~     model.~   "
251457|NCT00260481|"~     The purpose of this study is to assess the efficacy of the PROMETA pharmacotherapy compared~     to placebo for initiating abstinence and for preventing relapse to methamphetamine use in~     treatment-seeking individuals meeting criteria for methamphetamine abuse. It is hypothesized~     that individuals assigned to receive the PROMETA pharmacotherapy, compared to placebo, will~     demonstrate significantly fewer and less intense withdrawal symptoms, more days abstinent~     from methamphetamine use, and fewer relapses to methamphetamine use as assessed by~     self-report of drug use verified by urine samples.~   "
251458|NCT00260468|"~     The objective of this project is to examine the state of the brain in people over 50 years~     old suffering from late-onset depression by means of an extensive clinical assessment~     programme, including magnetic resonance imaging (MRI), neuropsychological testing,~     neurological examination, eye examination as well as blood and saliva samples. The results~     are to be compared with results from a control group matched for gender and age.~   "
251459|NCT00260442|"~     The purpose of this study is to examine the effect of dietary cholesterol administered as~     whole egg or egg white (control)on muscle mass gain with resistance training in a young old~     population of men and women (age 50-69). It is hypothesized that dietary cholesterol will be~     significantly associated to muscle mass gain.~   "
251460|NCT00260429|"~     The purpose of the study is to determine if collagenase will reduce the degree of contracture~     in the primary joint in subjects with Dupuytren's disease.~      This study was designed to be part of the larger clinical program, for adult patients with~     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal~     Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were~     evaluated.~   "
251461|NCT00260416|"~     Background: Acute balloon angioplasty is beneficial in patients with acute myocardial~     infarction. However, presently this treatment is not offered to patients with symptom~     duration above 12 hours.~      Hypothesis: Acute balloon angioplasty for myocardial infarction is beneficial despite symptom~     duration above 12 hours.~      Methods: In 60 patients with myocardial infarction and symptom duration above 12 hours, the~     proportion of non-perfused myocardium before acute angioplasty and 1 month after angioplasty~     is compared to evaluate if myocardial tissue can be saved by acute angioplasty despite long~     symptom duration.~   "
251462|NCT00260403|"~     The purpose of the study is to compare photodynamic therapy to transpupillary thermotherapy~     as a treatment method for choroidal neovascularization in age-related macular degeneration (~     AMD). AMD is a disease affecting the macula, the central area of the retina.There are two~     main types of AMD. Geographic atrophy ( dry) AMD and neovascular ( wet) AMD. In neovascular~     AMD, sub-retinal neovascular membranes ( new blood vessels) develop beneath the retina. The~     new vessels can leak causing haemorrhage that leads to significant visual loss. Photodynamic~     therapy ( PDT) is a method for treating neovascular membranes without affecting the retina.~     Photoactive chemicals are injected into the patient and irradiated with light as the pass~     through the neovascular membranes. This light is strong enough to activate the chemicals,~     that destroy the blood vessels, but not strong enough to cause damage to the overlying~     retina. The duration of the treatment is 83s. PDT treatment is effective in predominantly~     classic subfoveal choroidal neovascularization ( CNV), but was observed to yield no visual~     benefit in minimally classic CNV during a 2-year follow-up and as to occult CNV the effect~     was scarce. PDT does have its drawbacks, one of which is the cost. Another is that the~     patient become highly sensitive to strong light. Transpupillary thermotherapy ( TTT) is a~     thermic treatment of choroidal neovascularization in AMD. Using a thermal diode laser (~     emission 810 nm), transpupillary irradiation of the fundus through a conventinal contact lens~     is performed. The temperature is elevated < 10 degrees C during a 60s exposure to continuous~     radiation. The laser power is adjusted to the diameter of the laser beam. In a pilot study,~     Reichel et al. ( 1999) demonstrated that subfoveal occult CNV could be occluded and visual~     acuity stabilized in a majority of patients treated with TTT. These results has been~     confirmed in small series of cases with occult CNV and with minimally ( <50%) classic CNV.~     This prospective, randomized controlled study aim to compare TTT and PDT as a treatment for~     occult and minimally classic CNV. A total of 140 patients will be included in the study.~     Follow up is 2 years. The patients included will be followed as to visual acutiy ( ETDRS),~     new vessel growth ( fluorescien angiography and ICG), OCT and with a quality of life~     questionnarie.~   "
251463|NCT00260390|"~     Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men~     may be associated with age-related HPG hypofunctioning. In this study we seek to examine the~     efficacy of Testosterone replacement for this condition.~      Hypothesis:~      Testosterone replacement will be more effective than placebo, in treating men with late onset~     Dysthymic Disorder and hypo-gonadism.~   "
251464|NCT00260377|"~     Aspirin was proved to be the drug preventing vein grafts from closure and improving clinical~     outcome after coronary artery bypass surgery. It appears to be effective when being~     prescribed as early as first 48 hr. after the operation without increasing the incidence of~     bleeding complications. the exact effective dose is not known.~   "
251465|NCT00260364|"~     Pancreatic cancer is an aggressive, largely chemo-resistant disease with a poor prognosis.~     EGFR and VEGF are both overexpressed in pancreatic cancers and thought to contribute to~     tumour development and progression. The combination of gemcitabine and capecitabine has~     recently been shown to be effective in advanced pancreatic cancer. The combination of~     gemcitabine plus erlotinib has also been shown to be effective in advanced pancreatic cancer.~     The aim of this study is to assess whether combining a chemotherapy doublet (gemcitabine plus~     capecitabine) and a biologic doublet (erlotinib plus bevacizumab) is a safe and effective way~     to treat advanced pancreatic cancer by targeting multiple tumour stimulating mechanisms~     simultaneously.~   "
251466|NCT00260351|"~     -  To demonstrate that rabies vaccine administered according to the Thai Red Cross,~          (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according~          to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects~          with a WHO category III rabies exposure,or,~        -  To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen~          (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen~          in terms of GMTs at D28, in subjects with a WHO category III rabies exposure.~      Secondary objectives:~        1. To describe the immunogenicity profile of each regimen~        2. To assess the safety of the vaccine in each group.~   "
251467|NCT00260338|"~     Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into~     endothelial cells and participate in the development of new blood vessels in ischemic tissue.~      The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical~     effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial~     ischemia.~   "
251483|NCT00260130|"~     The 2010 National Health Objectives call for a reduction in the prevalence of obesity. The~     marked recent increase in overweight and obesity prevalence implicates behavioral factors in~     the etiology of the epidemic. The present proposal hypothesizes the trend is attributal, in~     part, to increasing consumption of energy-yeilding beverages since they are a significant and~     increasing source of dietarty energy and they elicit weaker appetitive and dietary responses~     than solid foods.~   "
251468|NCT00260325|"~     Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to~     injury could reduce or prevent the development of secondary hyperalgesia around the area of~     primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy~     volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg~     vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat~     stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the~     experiment.~   "
251469|NCT00260312|"~     The purpose of this study was to evaluated the effectiveness of inactivated poliovirus~     vaccine at a vaccine schedule that is commonly used in developing countries. The~     effectiveness of inactivated poliovaccine given at this schedule is important to national~     policy makers as they consider vaccination policies after the use of oral polio vaccine is~     discontinued.~   "
251470|NCT00260299|"~     Participants wanted for study of mevalonate kinase deficiency (MKD), mevalonic aciduria, or~     hyperimmunoglobulinemia with periodic fever syndrome (HIDS).~      Patients with MKD (mevalonic aciduria or hyperimmunoglobulinemia with periodic fever syndrome~     (HIDS)) may be eligible for a research study conducted at Oregon Health & Science University~     (OHSU) in Portland, Oregon USA. The purpose of the study is to find out more about how these~     diseases affect body chemistry and health. The researchers also want to find out how~     cholesterol in the diet affect blood cholesterol and how the body handles cholesterol. This~     is a short-term and long-term dietary study. The long-term goal of this research is to see if~     controlling dietary cholesterol can decrease any of the symptoms of the diseases.~      The study could involve up to 12 one-week admissions to OHSU over the course of 5 years.~   "
251471|NCT00260286|"~     The purpose of this experiment is to investigate whether the dependence of luteinizing~     hormone pulsatility on energy availability declines during adolescence.~   "
251472|NCT00260273|"~     Schizophrenia is one of society's most costly medical conditions and the most severe among~     psychiatric disorders. One of the most important and exciting new concepts in psychiatry is~     that detection and intervention very early in the course of schizophrenia offers what may be~     the field's best practical hope for realizing substantive improvements in the outcome of~     schizophrenia or schizophrenia spectrum disorders. Thus, we propose a five year program that~     focuses on three interconnected major research streams: (1) an evaluation of the~     effectiveness and cost-effectiveness of a model-driven psychological intervention in~     preventing or delaying the onset of a psychotic illness; (2) a qualitative study of the~     pathways to mental health at this time of very high risk; and (3) an exploration of the~     burden to the healthcare and informal caregiver systems associated with this high risk~     population.~   "
251473|NCT00260260|"~     Patients undergoing surgery (thyroidectomy and hysterectomy) will postoperatively receive~     oxycodone intravenously (IV) as pain management with morphine as an escape medicine, if there~     is insufficient pain relief with oxycodone. Patients' pain and side effects will be~     registered and after 24 hours they will answer a questionnaire. All included patients will be~     genotyped accordingly to CYP2D6 and relevant single nucleotide polymorphisms (SNPs), and~     measures of plasma levels of oxycodone will be performed.~   "
251474|NCT00260247|"~     This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that~     metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of~     these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical~     observations suggest that oxcarbazepine does not induce these enzymes to the same degree.~      This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4~     enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme~     activity.~      It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.~   "
251475|NCT00260234|"~     Insulin dependent Type I diabetics require daily insulin therapy to normalize blood glucose~     but may have difficulty with significant glycemic excursions and hypoglycemic episodes and~     crises. Islet cell transplantation can provide relief from daily insulin therapy, normalize~     blood glucose and reduce or eliminate short and long-term diabetes-related complications.~     PEG-Encapsulated Islet Allografts is a new islet transplant product under development that~     does not require the ongoing use of immunosuppressive drugs after the implant. This study~     will test the safety and efficacy of PEG-Encapsulated Islet Allografts in the treatment of~     Type I diabetes and provide functional outcome measurements.~   "
251476|NCT00260221|"~     Using Virtual Reality Hypnosis to relief pain and anxiety for burn patients.~   "
251477|NCT00260208|"~     Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases~     and over time causes fibrosis and eventually cirrhosis of the new liver. The aim of this~     study was to see if the frequency of liver fibrosis was different with cyclosporine~     microemulsion than tacrolimus~   "
251478|NCT00260195|"~     This study will develop a program to help school children deal with violence-related trauma.~   "
251479|NCT00260182|"~     This study will identify specific genes that may cause a predisposition to depression in some~     families.~   "
251480|NCT00260169|"~     This study will determine ways to make depression care more responsive to the needs of~     consumers in primary care clinics serving low-income Latinos.~   "
251481|NCT00260156|"~     This study is not being conducted in the United States. The purpose of this study is to~     assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic~     islet function in people with type 2 diabetes who have not previously been treated with drug~     therapy to lower their blood sugar.~   "
251482|NCT00260143|"~     Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though~     they may try to eat more food to gain weight. The reasons for this weight loss are not clear.~     Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone~     that is naturally produced in the bodies of both men and women and has important effects on~     building muscle and bone mass. The purpose of this study is to find out if providing~     additional testosterone to HIV infected men who have low testosterone can help them gain~     weight, increase their muscle mass, and feel better. The study will also help see if~     testosterone improves the efficiency with which your body produces and uses energy including~     fat. The dose of testosterone being used in this study will raise testosterone levels in the~     blood to higher than normal levels (2-3 times normal level).~   "
251484|NCT00260117|"~     Each year, a significant portion of men and women who engage in physical activities such as~     walking or running reduce their activity and by doing so place themselves at greater risk of~     obesity, heart disease, and diabetes. Our own prospective epidemiological studies of runners~     and walkers suggest that during 7.6 years of follow-up over 40% have reduced their mileage by~     half or more. Research suggests that social support, perceived health benefits, resiliency to~     interruptions in training, and exercise self-efficacy predict successful maintenance. We have~     found that runners who successfully maintained or increased their running mileage during this~     follow-up were more likely to have participated in social events such as marathon,~     half-marathon, or 10km races.~      The purpose of this study is to build upon our current Internet-based survey tools~     (www.healthsurvey.org) for tracking physical activity and nutrition on full-function activity~     and diet logs. The existing software allows participants to visualize their accumulated~     running and walking mileage on a virtual transcontinental route starting in Yorktown,~     Virginia and ending in Florence, Oregon. To the existing software, we will add the ability~     to: 1) choose named or anonymous running and walking partners with similar goals and~     abilities to travel with (or race against) along the transcontinental trail, 2) communicate~     with partners to provide mutual support, 3) compete as part of virtual running and walking~     teams created by the user, and 4) be recognized for completing each state on an awards page~     (optional). Interest in the site will be maintained by providing regular updates on~     scientific research on running and walking through our proprietary software. The updates will~     be created from PubMed abstracts that are made more reader friendly by defining all~     scientific terms in pop-up balloons.~   "
251485|NCT00260104|"~     It would be useful to study coronary arteriovenous difference of various markers in patients~     who are undergoing coronary angiography for suspected coronary artery disease. Environmental~     and genetic factors may play a role in the progression of coronary artery disease. The goal~     of this project is to establish a series of cross-sectional / case-control studies to~     evaluate risk factors of coronary artery disease in China.~   "
251486|NCT00260091|"~     The purpose of this randomized prospective clinical trial is to determine whether an~     infertility treatment that moves quickly to In Vitro Fertilization (IVF) is more cost~     effective than the usual treatment strategy which includes various combinations of~     infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro~     Fertilization.~   "
251487|NCT00260078|"~     Limited data exist about combination anti-HIV treatment regimens in children, including how~     those drugs are cleared by the body in children. The purpose of this study is to measure the~     blood levels of the following combinations of anti-HIV drugs in HIV infected chilren:~     tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and~     darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.~   "
251488|NCT00260065|"~     The purpose of this study is to determine the overall response rate in patients with~     myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.~   "
251489|NCT00260052|"~     To determine if the early administration of erythropoietin to patients sustaining traumatic~     brain injury will reduce secondary brain injury.~   "
251490|NCT00260039|"~     This dose-ranging study is to evaluate an investigational vaccine with the following~     objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate~     immune responses in women who are between 16 and 23 years of age at enrollment.~   "
251491|NCT00260026|"~     Researchers from Memorial Sloan-Kettering Cancer Center are conducting a research study on a~     Chinese herbal medicine known as Jin Fu Kang. We want to see if this can help patients with~     advanced lung cancer. Jin Fu Kang might reduce the growth of cancer or improve quality of~     life. You are eligible for this trial because your cancer has progressed after prior~     chemotherapy and your doctor has recommended further chemotherapy treatment.~      Lung cancer that has been confirmed and that has spread is called advanced cancer. There is~     no known permanent cure for advanced lung cancer, but chemotherapy may temporarily shrink the~     cancer and improve the quality of patients' lives.~   "
251492|NCT00260013|"~     The objective of the Transition into Primary-care Psychiatry (TIPP) project is to determine~     how feasible it is to conduct a study to evaluate a new primary-care focused program of~     mental health care delivery for people with chronic mental illness. This will be done by~     comparing a primary-care based collaborative, interdisciplinary model to care-as-usual on~     health related quality of life, client symptomatology, client's perceived need of care,~     participant satisfaction and cost-effectiveness.~   "
251493|NCT00260000|"~     The main purpose is to test whether treatment with BH4-tablets can replace the protein~     restrictive diet in patients with mild PKU caused by a certain frequent mutation.~   "
251494|NCT00259987|"~     This Phase II study will assess the efficacy, safety, and pharmacodynamics and~     pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with~     relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric~     cardia.~   "
251495|NCT00259974|"~     Polyneuropathy associated with anti-MAG monoclonal IgM gammopathy is responsive of mainly a~     sensory deficit in predominantly males ,aged 40-70 years. Significantly high serum anti-MAG~     antibodies are linked with demyelinating features of the peripheral nerves.Rituximab, an~     anti-CD 20 monoclonal antibody is a new drug which reduces B-lymphocytes. This study will~     test the safety and efficacy of rituximab in the treatment of patients with anti-MAG~     polyneuropathy.~   "
251496|NCT00259961|"~     Long-term results following laparoscopic and open Nissen fundoplication for~     gastro-oesophageal reflux will be objectively assessed in a selected population of patients~     already included in a randomized controlled trial comparing the two different techniques. The~     presence of postoperative symptoms will be evaluated by an independent clinician using an~     objective questionnaire. The recurrence of gastro-oesophageal reflux will be studied by~     24-hours pH study. Furthermore the presence of gastric motility disorders will be studied by~     electrogastrography and 13C-octanoic acid breath test.~   "
251497|NCT00259948|"~     The purpose of this study is to examine the effect of Aerobic Physical Activity on the~     function of the Autonomic System in patients after Myocardial Infarction or Stroke.~      A secondary objective is to examine whether it is possible to predict which of the patients~     will most benefit from physical activity (exercise training), taking into account, genetic~     factors such as Polymorphism of ACE (Angiotensin Converting Enzyme)~   "
251498|NCT00259935|"~     The purpose of this study is to determine the bioequivalence of the new oral capsule~     formulation to the currently used oral capsule formulation of topotecan.~   "
251542|NCT00259363|"~     -  Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed~          doses of oxaliplatin in this study~        -  Phase II: To determine the treatment efficacy according to response rates from phase I.~   "
251499|NCT00259922|"~     Adults who are taking opioid therapy for persistent non-cancer pain and have resulting~     opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms,~     or to placebo. The primary objective of this phase 3 confirmatory study is to compare~     alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is~     based on frequency of bowel movements. Subjects will be required to: (1) track their bowel~     movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.~   "
251500|NCT00259909|"~     The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire~     measuring the impact of an acute exacerbation on daily lives of patients with chronic~     obstructive pulmonary disease (COPD). This questionnaire will aim to detect an acute~     exacerbation and resolution of exacerbation from the patient's perspective. At a later stage~     of development, this questionnaire will be able to measure the effect of anti bacterials in~     the treatment of acute exacerbations of COPD (AECOPD). This study will evaluate the factor~     structure, validity, reliability, and responsiveness of the GSK questionnaire in subjects who~     experience acute exacerbations of their COPD.~   "
251501|NCT00259896|"~     This study is a placebo-controlled study in both healthy normal subjects and patients with~     Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is~     given for 7 days, and to assess the impact this medication has on various substances in the~     blood. Assessments include repeat blood sampling and monitoring of any side effects.~   "
251502|NCT00259883|"~     This study was designed to assess the efficacy and safety of combination therapy of PAXIL and~     benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or~     depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in~     the symptoms of depression will be evaluated by use of the rate and extent of decrease in~     Hamilton Rating Scale for Depression (HAM-D).~   "
251503|NCT00259870|"~     This is a two part study designed to evaluate the safety and efficacy of SB-773812 in the~     treatment of acute schizophrenia. Subjects with acute schizophrenia will be randomized in an~     adaptive design study to receive placebo, SB-773812 60mg or olanzapine 15mg for 12 weeks in~     Part A. An interim analysis will be conducted to assess the efficacy and safety of the~     SB-773812 60mg dose compared with placebo. Based on these data, up to two further doses of~     SB-773812 will be added to the randomization for Part B.~   "
251504|NCT00259857|"~     We have previously evaluated the safety and efficacy of Alendronate in 10 patients with~     juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate~     improved BMD of the spine and hip without any major side effects. There were no additional~     fractures during therapy. The present study is designed to further evaluate the safety and~     efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind,~     randomized, placebo-controlled, cross-over protocol.~   "
251505|NCT00259844|"~     This study will test the safety and efficacy of TroVax in patients undergoing surgical~     resection of colorectal cancer with liver metastases.~      TroVax potentially works by encouraging the immune system to react against the 5T4 protein on~     the surface of bowel cancer cells. The immune system is then able to recognise 5T4 and kill~     cells that carry it. The hope is that if tumour cells started to grow again after the main~     tumour has been surgically removed, the immune system would be able to find and destroy them.~   "
251506|NCT00259831|"~     The purpose of the Study is to determine the prophylactic effects of CVT-E002 treatment for~     upper respiratory tract infections in healthy adult employees working with residents in~     continuing care facilities. It is hypothesized that the use of CVT-E002 will effectively~     reduce the incidence, severity and duration of upper respiratory infections among the~     participants when compared to placebo.~   "
251507|NCT00259818|"~     This is a Phase I, dose escalation study of EM-1421 administered by intravenous infusion (IV)~     for five consecutive days every 28 days to patients with solid tumors refractory to current~     therapies. There have been no previous human studies of intravenous (into one's vein) EM-1421~     treatment; however, lab research (research in test tubes and/or animals) suggests that~     EM-1421 has shown some activity against tumors in animals. This activity in animal models~     suggests that EM-1421 may be a useful chemotherapy for human cancer.~      The primary objective of this study is to determine the safety and maximum tolerated dose of~     EM-1421 given by intravenous infusion. The efficacy of the treatment will also be measured.~   "
251508|NCT00259805|"~     The purpose of this study is to assess the safety, tolerability and effectiveness of~     rituximab in the treatment of chronic focal encephalitis.~   "
251509|NCT00259792|"~     The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with~     conventional stepwise treatment according to asthma treatment guidelines in patients with~     persistent asthma.~   "
251510|NCT00259779|"~     To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course~     of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute~     exacerbation of Chronic Obstructive Pulmonary Disease (COPD).~   "
251511|NCT00259766|"~     The purpose of this study is to compare health-related costs and asthma control in ordinary~     clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as~     needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and~     Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately~     controlled on inhaled glucocorticosteroids alone.~   "
251512|NCT00259753|"~     The objective of this study is to evaluate the safety and preliminary efficacy of three doses~     of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding~     for VEGF.~   "
251513|NCT00259740|"~     The purpose of this study is to determine if denosumab is effective in the treatment of~     relapsed or plateau-phase multiple myeloma.~   "
251514|NCT00259727|"~     The purpose of this study is to determine the mechanisms by which HIV protease inhibitors~     contribute to the development of diabetes in HIV-infected patients. The investigators propose~     that some HIV protease inhibitors impair insulin secretion and increase the production of~     glucose by the liver.~   "
251905|NCT00254527|"~     The intent of this study is to:~        1. Define the prevalence of MRSA carriage in the pediatric population in Kansas City.~        2. Systematically define patient risk factors for MRSA carriage and infection.~        3. Characterize the unique genetic characteristics of MRSA strains, both community acquired~          (CA) and healthcare associated (HCA) that are present in the different pediatric~          populations.~   "
251515|NCT00259714|"~     Salt and water excess is an essential mechanism of hypertension. This is particularly~     relevant to patients with end stage kidney disease (ESKD) on dialysis. We have demonstrated~     that individualization of the sodium concentration in the dialysate as to match the patient's~     own serum sodium concentration leads to less thirst, interdialytic weight gain, and better BP~     control in hypertensive patients. In this study we will evaluate the mechanisms underlying~     this response by measuring systemic hemodynamics, body volume spaces, and biochemical marker~     of volume status.~   "
251516|NCT00259701|"~     This study attempts to test capillary responses to various challenges without the need for~     iontophoresis (electrical current).~   "
251517|NCT00259688|"~     Hypothesis: The prevalence of sleep apnea is greater in pregnant women with preeclampsia than~     in pregnant women without preeclampsia.The presence of sleep apnea will be associated with~     poor blood pressure control, worsening blood pressure during sleep and evidence of fetal~     distress. The usual treatment for sleep apnea is to have the patient breathe pressurized air~     through a mask. This is called continuous positive airway pressure (CPAP). In preeclamptic~     women with sleep apnea, use of CPAP will result in improved blood pressure control and~     reduced fetal distress.~   "
251518|NCT00259675|"~     To see the efficacy of using chemotherapies alternatively (carboplatin and gemcitabine~     alternating with carboplatin and taxol) for pts with stage IIIB (nonresectable and stage IV~     NSCLC.~   "
251519|NCT00259662|"~     This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG~     coA reductase inhibitor class of drugs referred to as statins, will reduce inflammatory~     responses and deep vein thrombosis formation when given in high doses in the perioperative~     period.~   "
251520|NCT00259649|"~     Women are followed prospectively for 3 months, recording headaches, other symptoms, and~     menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan~     for 3 months.~   "
251521|NCT00259636|"~     Patients with fibromyalgia & migraine are randomized to receive zonisamide or placebo.~   "
251522|NCT00259623|"~     The objective of the study is to evaluate the efficacy of the epicardial or endocardial~     radiofrequency ablation in the treatment of atrial fibrillation.~      It is a multicentric, prospective, randomized, parallel, comparative, double blind study. The~     study principal objective is to evaluate the absence of atrial fibrillation after 3 months.~     The secondary objectives consist in the evaluation of the maintenance of the sinusal heart~     rate at one year and of the quality of life improvement~   "
251523|NCT00259610|"~     The purpose of this study is to 1)to determine if it is better to treat all early RA patients~     with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination~     with etanercept or reserve this treatment for patients who do not appropriately respond to~     methotrexate alone and 2) to determine which combination of methotrexate therapy is better~   "
251524|NCT00259597|"~     Breast nipple aspirate fluids (NAF) are useful for non-invasive monitoring of the breast. NAF~     has been shown to exhibit large inter-individual differences in lipid peroxidation.~     Unfortunately, the yield of epithelial cells in NAF is low. More recently, breast ductal~     lavage has been approved for clinical use. Nuclear morphologic features of breast biopsies~     have been shown previously to have prognostic value for breast cancer risk. In women without~     cancer, there may be subtle changes in the breast epithelial cells that can only be defined~     with computer-assisted measurements. The subjects selected for this study will be 98 women~     with biopsy-confirmed proliferative breast disease. These women are at slightly increased~     breast cancer risk, and exhibit higher mean levels of cholesterol and cholesterol oxides in~     NAF than women with non-proliferative histology in the breast. Levels of 8-isoprostane,~     cholesterol, fatty acids, fat-soluble micronutrients and 2,6-cyclolycopene-4,5-diol will be~     quantified in breast NAF that is obtained before breast lavage. These measures were chosen~     based on their potential relationship to dietary intakes and to oxidative stress, which is~     relevant to the application of these methods to dietary prevention studies.The investigators~     will characterize the morphology of breast epithelial cells from lavage using quantitative~     image cytometry to capture nuclear and cellular area, diameter, roundness, perimeter, and~     nuclear:cytoplasmic area ratio. Correlations will be evaluated between the measured~     morphologic features and each analyte in the NAF. The impact of various clinical, demographic~     and dietary factors on cellular morphology will also be explored. This study will help~     establish the feasibility of using these measures as endpoints in dietary intervention~     studies and will generate hypotheses that should be tested in larger studies. Such measures~     also should be applicable to molecular epidemiological investigations that seek to examine~     the impact of certain gene polymorphisms and environmental exposures on biomarkers of cancer~     risk.~   "
251525|NCT00259584|"~     All patients with symptomatic malignant SVCO deemed suitable for treatment either with~     radiation therapy or by stenting will be eligible. They will receive whichever treatment is~     deemed most clinically appropriate. Symptomatic response, time to onset of palliation,~     duration of symptom control and survival will be assessed.~   "
251526|NCT00259571|"~     The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as~     mesalazin in preventing an acute episode in ulcerative colitis.~      The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of~     the colonic mucus. The background of the study is the finding that the phosphatidylcholine~     content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy~     and inflamed parts of the colon.~   "
251527|NCT00259558|"~     The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine~     in the most severe form of ulcerative colitis.~      The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the~     colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine~     (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and~     patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon~     in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.~   "
251528|NCT00259545|"~     The purpose of this study is to evaluate if retarded release phosphatidylcholine is an~     effective alternative to steroid dependent or -refractory course in chronic active ulcerative~     colitis.~      The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus~     layer. The background of the study is the finding, that the phosophatidylcholine content of~     the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls~     and patients with Crohn´s disease. The content was measured in non-inflamed areas of the~     colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method~     for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.~   "
251953|NCT00253890|"~     The purposes of this study are:~        1. to evaluate the relationship between subjective complaints of sleep and objective~          measures of sleep quality, as measured through polysomnography, and~        2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in~          methadone maintenance.~   "
251529|NCT00259532|"~     The purpose of this project is to evaluate and compare three new methods for diagnosis,~     staging, operability evaluation and treatment control of pancreas cancer. The investigators~     use contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and~     Cholecystokinin, which triggers the enzyme production of pancreas. The hormones induce an~     increased metabolism and thus an increased blood flow through healthy pancreas tissue,~     however, not in tumor tissue. The investigators hope to be able to use this effect~     diagnostically. The patients included will also have a 64-slice-CT in order to evaluate, if~     an increased diagnostic safety can be reached compared to an older CT scanning method. All~     patients will also be examined for the tumor marker CA 19-9. Further, the investigators will~     examine if contrast-enhanced ultrasound can contribute with information in treatment control~     after either surgery or medical treatment.~   "
251530|NCT00259519|"~     Two-year multicentre randomized controlled parallel trial to compare intentional delivery and~     conservative management in pregnant women with preterm and prelabour rupture of membranes~     between 32 and 35 weeks.~      The purpose of this study is to determine whether intentional delivery of women with PPROM~     between 32 and 35 week's gestation can decrease the overall neonatal morbidity associated~     with PPROM-related complications without increasing the morbidity associated with a shortened~     pregnancy.~   "
251531|NCT00259506|"~     Research project regarding the possibility to implement and the efficacy of a non-drug,~     psychotherapeutic intervention (MBCT), in preventing relapse/recurrence of depression.~   "
251532|NCT00259493|"~     The purpose of this study is to compare graft patency rates following coronary artery bypass~     graft surgery performed by beating heart vs. conventional techniques using cardiac CT~     scanning to evaluate the bypass grafts.~   "
251533|NCT00259480|"~     The specific aims of this study are to:~        1. Test the immediate effectiveness of the intervention to reduce caregiver upset with~          targeted disruptive behaviors (primary outcome). Hypothesis: Caregivers in the~          intervention group will report less upset with target behaviors at 4-months in~          comparison to caregivers in the control group.~        2. Test the immediate effectiveness of the intervention to reduce caregiver burden~          (secondary outcome). Hypothesis: Caregivers in the intervention group will report less~          burden at 4-months in comparison to caregivers in the control group.~        3. Test the immediate effectiveness of the intervention to reduce the frequency of~          occurrence of targeted disruptive behaviors in persons with dementia (secondary~          outcome). Hypothesis: Caregivers in the intervention group will report a decrease in the~          frequency of occurrence of targeted behaviors at 4-months in comparison to caregivers in~          the control group.~        4. Test the maintenance effect of intervention at 6-months on caregiver upset and burden~          and targeted disruptive behaviors. Hypothesis: Compared to usual care, caregivers in~          intervention will maintain reduced upset and burden and report less occurrences of~          targeted behaviors from 4 to 6-months.~        5. Assess the cost of the intervention and its cost effectiveness.~      We have also received funding to conduct a supplementary study to evaluate the effect of the~     nurse intervention on behavior reduction and caregiver distress. The specific aims of this~     supplementary study arm are to: 1) describe the prevalence and type of medical conditions~     among control group participants who receive the nurse intervention, 2) describe for those~     with a detected medical condition/problem, the number of caregivers who follow-up with~     physicians and the type of physician follow-up/treatment that occurs; 3) evaluate whether~     control group participants who receive the nurse intervention report reduced disruptive~     behaviors and caregiver upset at 6 weeks (pre-post comparison); and 4) for control group~     participants who receive the nurse intervention, compare the level of disruptive behaviors~     and caregiver upset 4 months from entry into this study arm with the results in the Project~     ACT experimental group (who received the multi-component intervention).~   "
251534|NCT00259467|"~     Specific Aims~        1. Establish a preliminary effect size for the impact of the intervention on depressive~          affect and agitated behaviors in persons with dementia in 4 months~        2. Evaluate acceptance of and engagement in activities in persons with dementia~        3. Establish a preliminary effect size for the impact of the intervention on caregiver~          burden, depressive symptoms, and mastery at 4 months.~        4. Evaluate caregiver skills acquisition, acceptance of and compliance to intervention~          techniques.~   "
251535|NCT00259454|"~     This study tests the effectiveness of an in-home intervention to reduce upset and burden~     among family caregivers, and decrease nursing home placement. The main hypothesis that will~     be tested is that compared to control group, subjects, experimental group participants will~     have enhanced well-being and fewer nursing home placements.~   "
251536|NCT00259441|"~     The contrast induced kidney toxicity has been known to affect the mortality and morbidity in~     the patients undergoing coronary angiography. But the mechanism and therapeutic strategy for~     it is not well known. Nowadays, it is reported that the N-acetylcysteine may have preventive~     effects for contrast induced kidney toxicity with its antioxidant effects.The statins have~     been reported to have many other effects other than the lipid lowering effect-including~     antioxidant effect, so we hypothesized that the antioxidant effect of simvastatin may prevent~     the contrast induced kidney toxicity.~   "
251537|NCT00259428|"~     To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus~     rhythm after electrical, pharmacological or spontaneous conversion of atrial~     fibrillation/atrial flutter (AF/AFL).~      To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.~      To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of~     AF/AFL recurrence.~   "
251538|NCT00259415|"~     This study is a collaborative effort between a community-based service organization,~     Supportive Older Women's Network (SOWN), and an academic research division at Thomas~     Jefferson University (TJU). We plan to use a randomized controlled two-group design to: 1)~     test the effectiveness of the intervention at 6 months to enhance social support and~     perceived efficacy in comparison to a control group; 2) test if gains are sustained over 12~     months (within experimental group comparison); and 3) evaluate the cost and cost~     effectiveness of the intervention. Three secondary study aims are to describe the process and~     content of tele-support groups (dose/intensity, support group topics); evaluate the relative~     benefits for African American and White females; and determine if control group subjects~     benefit from receiving a peer's telephone number for mutual support (within group comparison~     between 6 and 12 months).~   "
251539|NCT00259402|"~     -  To determine the activity and efficacy of the schema specified as dose regimen~        -  To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU~   "
251540|NCT00259389|"~     Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV~     infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a~     strategy in which patients are observed while taking their medications, has been proven~     useful in increasing patient adherence. The purpose of this study is to determine the~     effectiveness of a new DOT strategy in HIV infected adolescents who have had difficulty~     adhering to anti-HIV drug regimens or regimens to prevent opportunistic infections (OIs) in~     the past.~   "
251541|NCT00259376|"~     To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus~     rhythm after electrical, pharmacological or spontaneous conversion of atrial~     fibrillation/atrial flutter (AF/AFL).~      To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of~     AF/AFL recurrence.~      To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.~   "
251543|NCT00259350|"~     The best antiseptic solution for cateheter care remains unknown.High concentration in aquous~     solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone~     iodine in aquous solutions. No study has compare alcoholic formulations of low concentration~     of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central~     venous catheters.~      To compare the incidence of central venous catheter colonization after skin disinfection with~     either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine,~     0.025% Benzalkonium and 4% benzylic alcohol.~      To compare the incidence of catheter related bacteremia in the to study groups. To compare~     the local and general tolerance of the two antiseptic formulations~   "
251544|NCT00259337|"~     The present clinical study will assess the immunogenicity as the primary objective and the~     reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined~     vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of~     age followed by a booster dose during the second year of life.~      Safety:~      This study will describe the safety after each dose of the primary series of the study's~     combined vaccine (Pentaxim™).~   "
251545|NCT00259324|"~     The US is in the midst of an obesity epidemic, affecting young children. The pediatric~     primary care setting is an ideal place to address this problem since most families have~     frequent contact with their pediatrician and a child's health status is regularly assessed in~     this setting. Recommendations for treating children with a body mass index (BMI) over the~     85th percentile in the primary care setting have been developed by an Expert Committee on~     childhood. Programs are needed that meet the recommendations from the Committee, which~     include: 1) beginning treatment as young as possible; 2) focusing on the family, with the~     parent being the primary change agent for treatment; 3) using behavior modification~     techniques to change eating and activity behaviors; and 4) making 2 or 3 very specific~     changes in diet and activity at one time. Thus, the aim of this R21 application is to~     develop, implement, and evaluate a 6-month behavioral childhood obesity intervention that~     meets the Committee's recommendations and can be implemented in a primary care setting. A~     second aim of this project is to determine which eating and activity behaviors should be~     targeted in the intervention. One hundred thirty-five children, aged 4 to 9 years with a BMI~     > 85th percentile, assessed and referred by their pediatricians, will be randomized to one of~     three conditions: 1) a newsletter condition; 2) a Behavioral Parenting Program that increases~     physical activity (60 min/day) and decreases sweetened drink consumption (< 3 servings/week)~     (Traditional); or 3) a Behavioral Parenting Program that reduces TV watching (< 2 hours/day)~     and increases low-fat milk consumption (2 servings/day) (Substitutes). Follow-up assessments~     on weight, height, and standardized BMI (z-BMI), the primary dependent variable, will be~     conducted at 3, 6, 9, and 12 months. Pediatricians will provide follow-up letters to~     families, regarding weight and height status, following the assessments. This pilot study~     allows us to determine the feasibility and efficacy of a pediatric obesity intervention that~     optimizes the role of the pediatrician and meets the Committee's recommendations for~     treatment in a primary care setting. Moreover, by comparing the effects of targeting the~     traditional or substitute behaviors, data will be obtained for a power analysis for a~     full-scale trial of the effects of these two approaches on long-term weight loss.~   "
251546|NCT00259311|"~     The purpose of this study is to determine whether a compound known as LY2422347 is effective~     in treating people diagnosed with primary insomnia (difficulty sleeping with no other~     significant contributing factor, such as depression).~   "
251547|NCT00259298|"~     The purpose of this study is to evaluate the effects of teriparatide on skeleton images in~     postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that~     stimulates the production of new bone in the skeleton. This process of bone formation can be~     studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This~     trial will test whether bone scans will identify areas of the skeleton that are forming new~     bone during teriparatide therapy. It also will study what these areas look like after therapy~     is stopped.~   "
251548|NCT00259285|"~     To determine the response to this regimen for therapy prior surgery in patients with locally~     advanced disease or metastatic disease.~   "
251549|NCT00259272|"~     A non randomized study to validate the MATHYS Scale in a population of in and outpatients~     greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and~     treated with olanzapine.~   "
251550|NCT00259259|"~     To evaluate the short-term effects of structured lipids on appetite regulation.~   "
251551|NCT00259246|"~     The aim of the study is to compare fasting and postprandial PYY levels between~     overweight/obese and lean subjects during and after an infusion of saline, PYY1-36 or PYY3-36~     and to evaluate the efects on appetite, energy intake and energy expenditure.~   "
251552|NCT00259233|"~     12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of~     PYY1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4~     escalating doses PYY3-36 on 5 different test days within one week. The patients will be~     tested in a single blinded dose escalating protocol. Measurements of appetite, ad libitum~     energy intake, blood pressure and blood sampling will be performed during the test day.~   "
251553|NCT00259220|"~     Gastric lavage is usually used for gastric preparation before endoscopy in patients with~     upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric~     tube in these patients is not clearly defined. This randomized trial is aimed to determine if~     the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the~     management of upper gastrointestinal bleeding.~   "
251554|NCT00259207|"~     The purpose of this study is to compare 2 techniques of pulmonary valve replacement in~     patients with a large right ventricular outflow tract: a standard surgical treatment using~     cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal~     circulation.~   "
251555|NCT00259194|"~     Coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding~     complications are often seen. To avoid/reduce bleeding complications digital compression is~     applied in the area of puncture during approximately 20 minutes and the patient is in the~     investigators' department observed in bed for 2 hours. The investigators apply pressure over~     the puncture site using a sand bag in the first hour. The patients are told not to move, to~     keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours~     (standard observation). In the present study the patients are randomized between standard~     observation and an alternative observation, where the patients are allowed to lift their~     head, arms and legs during the 2 hours, otherwise as standard observation.~      The study has three aims:~        1. To establish the incidence of bleeding complications:~             -  Frequency of hematoma (> 5 cm)~             -  Frequency of pseudoaneurysms~             -  Frequency of bleeding demanding surgery~             -  Frequency of bleeding demanding transfusion~        2. Establish a model to predict in wich patient to expect a bleeding complication.~        3. Assess if the alternative observation is associated with more bleeding complications~          compared to standard observation.~   "
251954|NCT00253877|"~     This study compares outcomes and metal ion levels between patients who receive the Conserve®~     Plus Hip System compared to those who have received a standard hip replacement in a recent~     study.~   "
251556|NCT00259181|"~     Chlorhexidine gluconate (CHX), as an anti plaque agent, is commonly used with a variety of~     products. In this study we, the investigators at Hadassah Medical Organization, intend to~     examine the efficacy of a single dip in CHX of provisional restoration prior to oral~     cementation. If the protocol is effective, we intend to calibrate it and recommend clinical~     use of the protocol. The examination of biofilm formation will be both with electron~     microscope and confocal scanning laser microscope.~   "
251557|NCT00259168|"~     The purpose of this study is to determine whether attenuation/normalization of elevated blood~     sugar after meals ameliorates vessel wall (endothelial) function in individuals with insulin~     resistance.~   "
251558|NCT00259155|"~     We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have~     an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the~     small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a~     dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic~     chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the~     lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this~     study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in~     IBS subjects with concomitant improvement in clinical symptoms.~   "
251559|NCT00259142|"~     Malaria remains a major cause of morbidity and mortality particularly among children < 5~     years in Uganda. Due to inaccessibility many children die before they reach the health~     facility. The Home Based Management of Fever (HBMF) strategy was adopted in Uganda as a mean~     to improve access to early and appropriate treatment of fever at community level. Pre-packed~     chloroquine with sulphadoxine-pyrimethamine (HOMAPAK) is provided through Community Drug~     Distributors(CDDs). Initial evaluation showed underutilization of the CDDs (15%). This cast~     doubt on community acceptability, accessibility as well as its feasibility and cost~     effectiveness. This 3-year project intends to compare community acceptability and cost~     effectiveness of two HOMAPAK distribution methods. The current CDD-based HOMAPAK distribution~     versus home-based HOMAPAK distribution. The study hypothesis is that home-based HOMAPAK~     distribution is more acceptable to the community and more cost effective than the CDD based~     HOMAPAK A non randomised community study will be conducted in two sub-counties of Mukono~     district. In the control arm, HOMAPAKs will be distributed through the CDDs while in the~     intervention arm, HOMAPAKs will be directly distributed to the caretakers in the homes. The~     study population are caretakers and their children < 5 years. At baseline a survey (Phase 1)~     with a sample size 657 in each study area will assess the common drugs stocked at home to~     treat malaria and the health seeking behaviour for malaria for children < 5 years and to~     determine the prevalence of malaria parasitaemia and anaemia among children < 5 years. Phase~     2 includes the intervention. The villages will be assigned to either the control or~     intervention arm. Anaemia and malaria parasitaemia among children with fever will be assessed~     through active case finding. The impact of either distribution system on accessibility,~     acceptability, sustainability, compliance, cost effectiveness and malaria morbidity will be~     assessed during the evaluation phase. Health education messages on malaria prevention and~     treatment will be given to both communities. Drug misuse will be limited by distributing~     HOMAPAKs according to the number of children <5years in each household. HOMAPAK will only be~     replenished after the caretaker returns a used packet to the CDD.~   "
251560|NCT00259129|"~     This is an open-label, non-randomized Phase I study of sorafenib 400 mg bid (2 x 200 mg~     tablets) in cancer patients. The primary objective of the study is to evaluate the effect of~     sorafenib on cardiovascular safety parameters. The secondary objectives are to evaluate the~     safety, pharmacokinetics, and anti-tumor activity of sorafenib in cancer patients~   "
251561|NCT00259116|"~     This trial is a single center, open-label, dose-finding study of recombinant human relaxin~     (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.~   "
251562|NCT00259103|"~     The purpose of this study is to assess the safety and efficacy of rhRlx for cervical~     ripening, when compared to a placebo.~   "
251563|NCT00259090|"~     To compare the anti-tumour effects as measured by changes in various biomarkers, of a~     combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal~     women patients with primary breast cancer who are awaiting curative-intent surgery.~   "
251564|NCT00259077|"~     The purpose of this study is to study safety and efficacy of omeprazole standard treatment in~     a Japanese non-erosive reflux disease population.~   "
251565|NCT00259064|"~     The purpose of the study is to determine if the addition of Iressa to Best Supportive Care~     treatment will increase the progression free survival of chemo-naïve, poor performance status~     patients, with stage IIIB or IV NSCLC.~   "
251566|NCT00259051|"~     The purpose of this study is to investigate the pharmacodynamic effect of omeprazole n a~     Japanese non-erosive reflux disease population~   "
251567|NCT00259038|"~     The study will evaluate the safety and efficacy of intravenous infusion of carperitide using~     pressure measurements inside the heart and great vessels and measuring carperitide~     concentration in the blood.~   "
251568|NCT00259025|"~     The main purpose of this study is to investigate whether intravenous infusion of a lipid~     emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate~     variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis~     patients.~   "
251569|NCT00259012|"~     The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic~     (PD) profiles to determine the safety and tolerability of single and multiple doses of~     pantoprazole in infants aged 1 through 11 months.~   "
251570|NCT00258999|"~     The study will evaluate the clinical utilization of skin Cholesterol (SC) for cardiovascular~     risk assessment in asymptomatic individuals at low, intermediate and high risk based on~     Framingham global risk estimates.~      Preliminary studies have suggested that SC is an easy to measure, noninvasive marker of~     cardiovascular risk. This study is intended to provide further data in support of broader~     clearance by the Food and Drug Administration for the use of SC as a tool to identify~     asymptomatic patients at increased risk of cardiovascular disease. Currently, SC testing is~     cleared for use as part of risk assessment in subject suspected of having significant~     multi-vessel disease.~      The current study data will be used to support the use of SC testing as part of~     cardiovascular risk assessment in subjects without suspected coronary artery disease (CAD).~   "
251571|NCT00258986|"~     The purpose of this study is to compare the effects of hand-assisted laparoscopic and~     mini-incision muscle-splitting donornephrectomy on living kidney donors. The hypothesis is~     that the mini-incision is not inferior to the laparoscopic technique.~   "
251615|NCT00258388|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. OGX-011 may help docetaxel and prednisone kill more tumor cells by making tumor~     cells less resistant to the drugs.~      PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone~     with or without OGX-011 works in treating patients with recurrent or metastatic prostate~     cancer that did not respond to previous hormone therapy.~   "
251572|NCT00258973|"~     The purposes of this study are to determine:~        1. Inter-site variability in CIMT image measurement using SonoCalcTM.~        2. If non-sonographer health care professionals working in an office practice setting can~          be trained to follow a carotid scanning protocol that permits (a) accurate measurement~          of CIMT and (b) determination of plaque presence.~        3. If (a) CIMT measurements and (b) determination of plaque presence by non-sonographer~          health care professionals are bioequivalent to those made by a core laboratory.~        4. If CIMT measurements and plaque assessment performed in office practices lead to~          meaningful changes in patient and physician behavior related to cardiovascular disease~          prevention.~   "
251573|NCT00258960|"~     Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that~     will be administered every 4 weeks.~      Sample size calculation will be done by means of Simon's method in 2 stages for phase II~     studies and will be based on the principal aim of the study (evaluation of the rate of~     objective response).~      The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate~     of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment~     when the rate of response targets be lower than 35 %. In this case, considering an alpha~     error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study~     would continue if more than 5 objective responses were found. The total number of patients to~     including in the study would be 44. The results will be significant if they find at least 20~     objective responses.~      Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.~   "
251574|NCT00258947|"~     Primary Objective:~      To estimate the smallpox vaccination take rate in healthy young adults not previously~     vaccinated with a smallpox vaccine.~      Secondary Objectives:~      To describe antibody response to vaccination and evaluate the take for each subject at~     various timepoints for each batch and pooled batches and to evaluate local signs, symptoms,~     and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.~   "
251575|NCT00258934|"~     All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will~     test whether an influenza vaccine is effective when injected by a route other than into the~     muscle. In order to prove this, the amount of antibodies in the blood will be measured before~     and after vaccination. In addition, the safety of both influenza vaccines will be tested by~     evaluating all serious reactions occurring after vaccination. The vaccine injected in this~     study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In~     addition, the safety of both influenza vaccines administered by different routes will be~     tested by evaluating all adverse events and especially all serious reactions.~      Primary Objective: To demonstrate and compare the immune response of an influenza vaccine~     after a single dose when administered by different routes.~      Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with~     the European Medicine Agency (EMEA) after the first injection.~   "
251576|NCT00258921|"~     To support physicians in their active management of hypertensive patients. By targeting~     specific systolic and diastolic blood pressure (BP) figures physicians will closely monitor~     the BP values and as such will have an individualized control of the treatment in each~     patient.~   "
251577|NCT00258908|"~     To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed~     combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration.~      To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.~   "
251578|NCT00258895|"~     Primary Objectives:~        1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of~          age who have previously received 4 doses of DAPTACEL® or Pentacel™.~        2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in~          DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of~          DAPTACEL® or Pentacel™.~      Observational Objectives:~        1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses~          to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously~          received 4 doses of DAPTACEL® or Pentacel™.~        2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.~        3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among~          subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a~          2nd dose of MMR.~   "
251579|NCT00258882|"~     To further characterize the vaccine safety profile and to identify any signals of potentially~     vaccine-related adverse events (AEs) not detected during pre-licensure studies.~   "
251580|NCT00258869|"~     We propose to develop novel diagnostic tests for severe sepsis and community acquired~     pneumonia (CAP). This program, entitled Community Acquired Pneumonia & Sepsis Outcome~     Diagnostics (CAPSOD), is a multidisciplinary collaboration involving investigators at six~     organizations: NCGR; Duke University Medical Center, Durham, NC; Henry Ford Hospital,~     Detroit, MI; Eli Lilly and Company, Indianapolis, IN; Indiana Centers for Applied Protein~     Sciences, Indianapolis, IN; and ProSanos Corp., La Jolla, CA.~      In the United States, Community Acquired Pneumonia is the sixth leading cause of death and~     the number one cause of death from infectious diseases. Of the 5.6 million annual cases of~     CAP, 1.1 million require hospitalization for intensive therapy. Sepsis, commonly known as~     blood poisoning or bloodstream infection, is the tenth leading cause of death in the US and~     the number one cause of death in non-cardiac intensive care units. Incidence of sepsis is~     increasing by 9% each year and mortality rates vary between 25 and 50%. Cost to the US~     healthcare system exceeds $20 billion each year.~      In patients with suspected sepsis or early CAP, rapid identification of patients who will~     develop severe sepsis or CAP is critical for effective management and positive outcome. The~     CAPSOD study is designed to identify novel tests for early diagnosis of severe sepsis and~     CAP. When performed in patients at the earliest stages of disease, these tests will have~     prognostic value, rapidly identifying those who will have poor outcomes or complicated~     courses.~      CAPSOD will prospectively enroll patients with sepsis and CAP at Duke University Medical~     Center and Henry Ford Hospital. The study will use advanced bioinformatic, metabolomic,~     proteomic and mRNA sequencing technologies to identify specific protein changes, or~     biomarkers, in patient blood samples that predict outcome in sepsis and CAP. Development of~     biomarker-based tests will permit patient selection for appropriate disposition, such as the~     intensive care unit, and use of intensive medical therapies, thereby reducing mortality and~     increasing effectiveness of resource allocation.~   "
251581|NCT00258856|"~     The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged~     7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study~     603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of~     participants who will receive a booster dose of Menactra® vaccine and children in the same~     age group not previously vaccinated with a meningococcal vaccine or had meningitis disease~     who will receive a dose of Menactra® vaccine.~   "
251582|NCT00258843|"~     To describe the tolerance in terms of occurrence of serious adverse reactions and severe~     adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX~     Polio™ administered in children and infants.~   "
251583|NCT00258830|"~     To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation~     of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and~     subjects aged ≥ 60 years.~      To describe the immune response (antibodies to hemagglutinin) 21 days following injection of~     the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in~     subjects aged 18-59 years and subjects aged ≥ 60 years.~      To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER)~     for further analysis by the Food and Drug Administration (FDA), Center for Disease Control~     and Prevention (CDC) and the World Health Organization (WHO) to support selection and~     recommendation of antigen strains for subsequent influenza vaccines.~   "
251584|NCT00258817|"~     To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for~     Disease Control and Prevention (CDC), and the World Health Organization (WHO) for~     characterization of circulating influenza strains.~      Observational Objectives:~      To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in~     the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to <~     36 months.~      To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine,~     administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥~     6 months to < 36 months.~   "
251585|NCT00258804|"~     Primary Objectives :~        -  To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic,~          nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and~          glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan.~      Secondary Objectives :~        -  To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and~          8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected~          with a blood glucose monitor through a monthly patient diary).~        -  To assess the relationship between hypoglycaemia events during Ramadan and blood glucose~          control prior and during Ramadan.~        -  To assess patient satisfaction~        -  To document adverse events (all serious adverse events, non serious adverse events)~          throughout the study (all events will be collected through the monthly patient diary).~   "
251586|NCT00258791|"~     The purpose of the study is to determine whether ibuprofen reduces post-ECT headache or~     reduces its severity.~   "
251587|NCT00258778|"~     Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the~     human glucocerebrosidase gene (GCD)leading to reduced activity of the lysosomal enzyme~     glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer)in~     the cells of the monocyte-macrophage system.~      This is the first trial to utilize a recombinant active form of lysosomal enzyme,~     glucocerebrosidase, (human prGCD)which is expressed and purified in a bioreactor system from~     transformed carrot plant root cell line.~   "
251588|NCT00258765|"~     Radical prostatectomy is used to treat early prostate cancer in otherwise well men, but is~     followed by later cancer relapse in 1 in 4 cases. This study aims to see if post-operative~     adjuvant therapy with a combination of zoledronic acid and docetaxel might help reduce~     relapse in such cases. Patients will be randomized to receive the adjuvant combination~     therapy or no therapy. All patients will be monitored closely for signs of relapse and~     treated appropriately with conventional salvage therapy.~   "
251589|NCT00258752|"~     This study will compare Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST),~     IPT-AST plus parent involvement (Enhanced IPT-AST), and Usual Care for the prevention of~     adolescent depression.~   "
251590|NCT00258739|"~     Primary objective:~        -  To classify the 2 study groups, according to the tumoral response.~      Secondary objectives:~        -  To evaluate the percentage of focused control per year.~        -  To calculate the time until progression.~        -  To evaluate the safety profile.~   "
251591|NCT00258726|"~     This study will test the safety and how well the body's immune system responds to a live, but~     weakened varicella (chickenpox) vaccine, known as Varivax, given with and without ProQuad,~     another measles, mumps, rubella, and varicella virus vaccine (MMR-II). One hundred five~     healthy children will be enrolled in the study when they are 12 months old. All subjects will~     be vaccinated at 12 months of age and some subjects will receive a second vaccination at 18~     months of age. All subjects will participate for 1 year. This study is a single-site,~     two-year trial with post-licensure vaccines.~   "
251592|NCT00258713|"~     The purpose of this study is to determine the safety and efficacy of voclosporin in patients~     with plaque psoriasis.~   "
251593|NCT00258700|"~     The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC~     conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal~     serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month~     schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15~     months of age.~   "
251594|NCT00258687|"~     The purpose of this study is to learn if a vaccine made from the patient's own tumor cells,~     then genetically modified to secrete granulocyte-macrophage colony-stimulating factor~     (GM-CSF), will delay or stop the growth of the tumor. It will also look at the vaccine's~     effects on the immune system and the side effects of giving a vaccine made from a subject's~     own cancer cells.~   "
251595|NCT00258674|"~     The purpose of this study is to test the effectiveness of physician profiling and care~     coordination by a diabetes resource nurse in improving the quality of diabetes care.~   "
251596|NCT00258661|"~     Osteopathic Manipulative Treatment (OMT) were used in the 1800s and 1900s to treat pneumonia~     before the introduction of antibiotics in the mid-1900s. The purpose of this study is to~     determine if OMT, when used in conjunction with antibiotics and other usual care, will~     improve the recovery of elderly pneumonia patients.~   "
251597|NCT00258635|"~     The purpose of this study is to assess the immunological differences between three~     RagweedMATAMPL treatment arms compared to placebo with respect to immunoglobulin levels.~      In addition, the study will assess the reduced allergenicity of modified Ragweed Pollen~     contained in RagweedMATAMPL compared to unmodified native allergen using skin prick testing.~   "
251598|NCT00258622|"~     Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine~     and placebo in patients with peripheral chronic neuropathic pain.~   "
251599|NCT00258609|"~     The purpose of this study is to determine whether 120 Unit, and 240 unit of botulinum toxin A~     are effective in the treatment of migraine without aura prophylaxis.~   "
251600|NCT00258596|"~     Primary intracoronary stent placement after successfully crossing chronic total occlusions~     (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional~     balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in~     selected groups of patients. Whether sirolimus-eluting stents are superior to bare metal~     stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation~     will be compared with sirolimus-eluting stent implantation for the treatment of chronic total~     coronary occlusions. A total of 200 patients will be followed up for 6, 12, and 24 months~     with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by~     an independent core laboratory. The primary end point is the binary angiographic restenosis~     and reocclusion rate at 6 month follow-up.~   "
251601|NCT00258583|"~     The purpose of this study is to place past, current, and future medical record information~     into the UPMC Simmons Center for Interstitial Lung Disease Research Registry.~   "
251602|NCT00258570|"~     The purposes of this study are:~        -  to determine if there are specific genetic traits that might explain why patients have~          developed pulmonary fibrosis;~        -  to determine if specific genetic traits account for differing patterns of inflammation~          and scar tissue that has formed in the patient's lungs.~   "
251603|NCT00258557|"~     The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r~     versus Kaletra (a combination pill of lopinavir and ritonavir, (lpv/rtv) in HIV-1 infected~     patients who have never been treated with anti-retroviral medications (referred to as~     treatment-naïve patients).~   "
251604|NCT00258544|"~     This study is investigating the way the lung is damaged in a condition called pulmonary~     fibrosis. Research studies will be conducted on lung tissue obtained from an open lung biopsy~     performed by the subject's surgeon. The identification of unique genetic markers of scarred~     lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary~     fibrosis.~   "
251605|NCT00258531|"~     -  A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for~          routine use during colonoscopy.~        -  No randomised trials have been performed to evaluate if, and to what extent, the use of~          this technology may improve the coecal intubation rate and reduce the patient's~          experience of discomfort and pain by making the insertion of the endoscope easier~   "
251606|NCT00258518|"~     The investigators aim to compare the respiratory mechanics in acute lung injury (ALI)/acute~     respiratory diseases syndrome (ARDS) patients with and without pleural effusion.~   "
251607|NCT00258505|"~     The outcome of brain injury (physical or stroke) may be related to a brain electrical~     phenomenon known as Cortical Spreading Depression (CSD). This is a brief cessation of~     function in a local region of brain tissue. It has been hypothesized that CSD may occur after~     brain injury and may expand the damage to adjacent brain areas. Our aim is to detect CSD by~     means of intracranial electrodes in patients with brain injuries and asses how these events~     alter the outcome of the patients.~   "
251608|NCT00258492|"~     A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep~     quality among patients with Restless Legs Syndrome (RLS). We, the researchers at Northeastern~     Ohio Universities College of Medicine, hypothesize that, relative to a control group, RLS~     sufferers who participate in an aerobic exercise intervention will demonstrate:~        1. reduced RLS symptoms;~        2. improved sleep quality;~        3. reduced daytime sleepiness.~   "
251609|NCT00258479|"~     Nicotine is one of the most widely abused substances in the United States. Nicotine~     replacement therapy (NRT) is currently an effective treatment for nicotine dependence;~     however, even with NRT most people fail at quitting smoking after their first attempt.~     Modafinil is a promising drug that may be useful in treating nicotine dependent individuals.~     The purpose of this study is to evaluate the safety of the combination of modafinil and NRT~     in treating nicotine dependent adolescent smokers.~   "
251610|NCT00258466|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not~     yet known which type of radiation therapy is more effective in treating prostate cancer.~      PURPOSE: This randomized phase III trial is studying different types of radiation therapy to~     compare how well they work in treating patients with stage I, stage II, or stage III prostate~     cancer.~   "
251611|NCT00258453|"~     RATIONALE: Collecting information on how craniopharyngioma is diagnosed and treated may help~     doctors predict a patient's response to treatment and help plan the best treatment. It may~     also help identify the intermediate- and long-term effects of treatment.~      PURPOSE: This clinical trial is collecting information on diagnosis, treatment, and quality~     of life of young patients who are undergoing surgery for craniopharyngioma.~   "
251612|NCT00258440|"~     RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat~     anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with~     anemia.~      PURPOSE: This randomized clinical trial is studying how well epoetin alfa works in treating~     patients with anemia who are undergoing chemotherapy for cancer.~   "
251613|NCT00258427|"~     RATIONALE: A bone marrow or umbilical cord blood transplant may be able to replace~     blood-forming cells that were destroyed by chemotherapy. Giving combination chemotherapy~     before a donor stem cell transplant may make the transplant more likely to work. This may be~     an effective treatment for patients with high risk Fanconi's anemia.~      PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating~     high risk patients who are undergoing a donor stem cell transplant for Fanconi's anemia.~   "
251614|NCT00258401|"~     RATIONALE: Eating a diet low in residue (fiber, fat, and certain milk or vegetable products)~     may help prevent or reduce diarrhea caused by pelvic radiation therapy.~      PURPOSE: This randomized clinical trial is studying a low-residue diet to see how well it~     works compared to no dietary intervention in treating diarrhea in patients who are undergoing~     radiation therapy to the pelvis for uterine, cervical, or prostate cancer.~   "
251616|NCT00258375|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011~     may help docetaxel kill more tumor cells by making tumor cells more sensitive to the drug.~      PURPOSE: This phase II trial is studying how well giving OGX-011 together with docetaxel~     works in treating women with locally advanced or metastatic breast cancer.~   "
251617|NCT00258362|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination~     chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed~     by radiation therapy works in treating patients with stage III, stage IV, or recurrent~     endometrial cancer.~   "
251618|NCT00258349|"~     This phase I/II trial is studying the side effects and best dose of vorinostat when given~     together with trastuzumab and to see how well they work in treating patients with metastatic~     breast canceror breast cancer that has recurred in the chest wall. Vorinostat may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor~     cells and kill them or carry tumor-killing substances to them. Others interfere with the~     ability of tumor cells to grow and spread. Vorinostat and trastuzumab also may stop the~     growth of tumor cells by blocking blood flow to the tumor. Giving vorinostat together with~     trastuzumab may be a better way to block tumor growth.~   "
251619|NCT00258336|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others~     interfere with the ability of cancer cells to grow and spread. Vaccines made from a person's~     cancer cells may help the body build an effective immune response to kill cancer cells.~     Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in~     bone marrow or peripheral blood. Giving rituximab together with vaccine therapy and GM-CSF~     may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with vaccine~     therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkin's lymphoma.~   "
251620|NCT00258323|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving more~     than one drug (combination chemotherapy) may kill more tumor cells. Cisplatin and~     fluorouracil may also make tumor cells more sensitive to radiation therapy. Gefitinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     radiation therapy together with combination therapy and gefitinib before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these~     treatments after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well giving radiation therapy together with~     combination chemotherapy and gefitinib before and after surgery works in treating patients~     with advanced esophageal or gastroesophageal junction cancer.~   "
251621|NCT00258310|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any~     remaining tumor cells.~      PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who~     have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck~     cancer.~   "
251622|NCT00258297|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can~     be removed.~      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with~     stage I, stage II, or stage III esophageal cancer that can be removed by surgery.~   "
251623|NCT00258284|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel~     works in treating patients with metastatic prostate cancer.~   "
251624|NCT00258271|"~     RATIONALE: Drugs used in chemotherapy, such as cladribine and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving cladribine and cytarabine together with imatinib~     mesylate may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate~     when given together with cladribine and cytarabine in treating patients with refractory or~     relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia.~   "
251625|NCT00258258|"~     RATIONALE: Paricalcitol may cause multiple myeloma cells to look more like normal cells, and~     to grow and spread more slowly. Paricalcitol may also stop the growth of the cancer cells by~     blocking blood flow to the cancer. Zoledronate may delay or prevent bone metastases in~     patients with multiple myeloma. Giving paricalcitol together with zoledronate may be an~     effective treatment for multiple myeloma or other plasma cell disorders.~      PURPOSE: This clinical trial is studying the side effects and best dose of paricalcitol when~     given with zoledronate in treating patients with relapsed or refractory multiple myeloma or~     other plasma cell disorders.~   "
251626|NCT00258245|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer~     cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells~     by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with~     bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide~     when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in~     treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.~   "
252305|NCT00249236|"~     The purpose of the study is to assess the effectiveness and safety of risperidone (an~     antipsychotic medication) versus placebo in treating mania during 3 weeks of treatment in~     patients with Bipolar I Disorder who suffer from manic or mixed episodes.~   "
251627|NCT00258232|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as capecitabine and irinotecan, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving celecoxib together with capecitabine and irinotecan may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving celecoxib together with capecitabine~     and irinotecan works in treating patients with recurrent or metastatic colorectal cancer.~   "
251628|NCT00258206|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving rituximab together with~     cyclophosphamide may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with~     cyclophosphamide works in treating patients with high risk, refractory, or relapsed multiple~     myeloma.~   "
251629|NCT00258193|"~     -  The primary objective of this trial is to compare the dose-ranging pharmacodynamic~          effects of orally administered placebo, and 100 and 1000 ug qd of MD-1100 Acetate on~          gastrointestinal transit in patients with C-IBS.~        -  The secondary objectives of this trial are:~             1. To compare the dose ranging pharmacodynamic effects of placebo, and 100 and 1000 ug~               MD-1100 Acetate once daily on time to first bowel movement after first drug intake.~             2. To describe and summarize the effects of placebo, and 100 and 1000 ug MD-1100~               Acetate once daily on stool frequency, stool consistency, ease of passage and~               sensation of incomplete evacuation during the Treatment Period relative to~               Baseline.~   "
251630|NCT00258180|"~     RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .~      PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young~     patients with severe autoimmune enteropathy.~   "
251631|NCT00258167|"~     -  Research demonstrates that the families of the seriously mentally ill are burdened by~          this caregiving role and by their responsibilities~        -  Research also demonstrates that family interventions are effective and that they have a~          potential to reduce family burden, as well as to improve the condition of the mentally~          ill patients.~        -  We assume that the sibling group intervention would be effective in reducing the family~          burden of the siblings, and that this reduction would be reflected in their replies to~          the Experience of Caregiving Inventory.~   "
251632|NCT00258154|"~     The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due~     to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the~     safety and immunogenicity of either vaccine.~   "
251633|NCT00258141|"~     The study will find out how effective rupatadine is in the treatment of mosquito bite~     symptoms in adult patients allergic to mosquito bites.~   "
251634|NCT00258128|"~     We believe that diet induced obesity leads to activation of the IKK/NF-kB inflamatory pathway~     and that chronic inflammation leads to insulin resistance and diabetes. In rodents,~     salicylates inhibit IKK/NF-kB and may improve insulin sensitivity. We will study if this is~     true in people.~   "
251635|NCT00258115|"~     Chronic subaccute inflammation may underlie the development of diabetes cardiovascular~     disease and other components of the metabolic syndrome. Rodent studies suggest diet induced~     obesity is associated with activation of the IKK/NF-kB pathway and this pathway can be~     inhibited by salicylates. This study seeks to determine the effect of salicylates in~     overweight persons.~   "
251636|NCT00258102|"~     The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an~     antibiotic) with that of oral lomefloxacin in the treatment of complicated urinary tract~     infections in adults.~   "
251637|NCT00258089|"~     The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an~     antibiotic) with that of oral ciprofloxacin in the treatment of complicated urinary tract~     infections in adults.~   "
251638|NCT00258076|"~     The objective of this study is to estimate the exposure to the hormones norelgestromin,~     norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers across~     multiple commercial lots of ORTHO EVRAÂ® (a transdermal contraceptive patch) and to compare~     these data to historical hormonal exposure data from one ORTHO EVRAÂ® clinical development~     lot.~   "
251639|NCT00258063|"~     The objective of this study is to estimate exposure to the hormones norelgestromin,~     norgestrel, and ethinyl estradiol in healthy female volunteers across multiple commercial~     lots of EVRAÂ® (a transdermal contraceptive patch manufactured by LOHMANN Therapie-Systeme),~     to compare these data to exposure data from one clinical lot, and to compare these data to~     exposure data from a commercially available oral contraceptive.~   "
251640|NCT00258050|"~     To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics~     of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to~     assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.~   "
251641|NCT00258037|"~     Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary~     incontinence after ischemic stroke measured by quality of life paramters.~   "
251656|NCT00257842|"~     Constipation is a common disorder and current treatments are unsatisfactory. Biofeedback may~     help patients with constipation and dyssynergic defecation, but its efficacy is unproven and~     whether this is due to behavioral modification or excessive attention is unknown. Methods: In~     a prospective randomized trial, the investigators investigated the efficacy of Biofeedback~     (manometric- assisted anal relaxation, muscle coordination and simulated defecation~     training), with either sham feedback therapy (Sham) or standard therapy (diet, exercise,~     laxatives; Standard) in 77 subjects (69 women) with dyssynergic defecation. Primary outcome~     measures included presence of dyssynergia, balloon expulsion time, number of complete~     spontaneous bowel movements (CSBM), and global bowel satisfaction. Data analyzed per~     protocol.~   "
251984|NCT00253461|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET scan) using 11C~     topotecan, may help doctors predict a patient's response to treatment and help plan the best~     treatment.~      PURPOSE: This phase I/II trial is studying how well a PET scan using 11C topotecan predicts~     response to treatment in patients with brain metastases due to ovarian, small cell lung, or~     other cancer.~   "
251642|NCT00258024|"~     Malaria is one of the major causes of illness and mortality in Sub-Saharan Africa. In Ghana,~     malaria is the most important cause of morbidity and accounts for about 40% of outpatient~     contacts. Chemoprophylaxis and insecticide-impregnated bed nets are used for malaria control~     in pregnancy.Chloroquine is administered within the ANC package at health facilities in~     Ghana. However, many pregnant women in rural,low-income communities do not report for ANC or~     report late thereby increasing their risk of morbidity and mortality. Reasons for this~     include inaccessibility and high cost. As the gap between urban and rural health care and~     socioeconomic circumstances increase, malaria control remains the major challenge of the~     health sector. A facility-based intervention alone is not sufficient to have a significant or~     sustained impact on malaria control in pregnancy. Alternative strategies are needed for the~     delivery of malaria interventions to pregnant women in rural areas in Ghana. The overall~     objective of this study is to develop alternative strategies for community involvement for~     delivery of malaria interventions to pregnant women in rural Ghana. The project will be~     conducted in the Afigya Sekyere district in the Ashanti Region of Ghana. Interviews and focus~     group discussions will be conducted with pregnant women and community members focusing on~     local knowledge on control of malaria in pregnancy and factors influencing utilization of~     antenatal services. Women in their first and second pregnancies who are permanently resident~     in the study area will be included in the study using IPT with sulphadoxine-pyrimethamine~     (SP). The study population will be randomized to:Group 1 will receive clinic-supervised~     IPT-SP and daily folate/iron supplementation and Group 2 will access IPT-SP with daily~     folate/iron supplementation from trained traditional birth attendants (TBA). Midwives and~     TBAs will be trained in preparing thick blood smears and placenta biopsies for~     parasitological examination. Parasitaemia and Hb will be measured at entry and at delivery~     and fever episodes during pregnancy will be recorded. Study participants will be followed for~     adverse reactions within a week after drug administration. The effectiveness of~     community-based IPT for the control of malaria in pregnancy will be determined. The endpoints~     of the study will be birth weight, maternal anaemia, fever episodes and prevalence of~     peripheral and placental parasitaemia in the groups.~   "
251643|NCT00258011|"~     This is a multi-center, open label, study conducted to evaluate the safety of laronidase~     administered by intravenous drip infusion in Japanese patients with MPS I disease.~      Following baseline evaluation, patients will receive weekly infusions of JC0498 at an~     intravenous dose of 100 units/kg. Patient safety will be monitored continuously throughout~     the trial. In addition, the effects of JC0498 treatment in this patient population will be~     assessed by periodically evaluating aspects of MPS I disease in patients at scheduled~     intervals over the duration of the trial.~      Since patients may be eligible for the trial if they have received JC0498, a portion of the~     data may be captured retrospectively and recorded onto the case report forms (CRFs).~      This study represents the first good clinical practice (GCP) effort to characterize MPS I in~     the Japanese population and evaluate the effects of JC0498 on disease manifestations.~   "
251644|NCT00257998|"~     Recently a clinical prediction rule (CPR) has been developed and validated that accurately~     identifies patients with low back pain that are likely to benefit from a lumbo-pelvic~     manipulation. The studies that developed and validated the rule used the identical~     manipulation procedure. However, recent evidence suggests that different manual therapy~     techniques may result in the same outcome.Purpose: The purpose of this study is to~     investigate the effectiveness of three different manual therapy techniques in a subgroup of~     patient with low back pain that satisfy the CPR.~   "
251645|NCT00257985|"~     The aim of the present study is to explore functional consequences of migraine gene mutations~     on their responses to GTN infusion.~   "
251646|NCT00257972|"~     The purpose of this research study is to compare the efficacy of aripiprazole with placebo in~     combination with lithium or valproate monotherapy, in the treatment of bipolar I patients~     with manic or mixed episodes.~   "
251647|NCT00257959|"~     This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta~     blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for~     spontaneous or inducible ventricular tachycardia or fibrillation~   "
251648|NCT00257946|"~     The objective of this study is to evaluate the use of 2 different types of biosynthetic~     material for the repair of congenital diaphragmatic hernia. The research question is: what is~     the best material for repairing large congenital diaphragmatic hernias? The primary outcome~     variable is recurrence.~   "
251649|NCT00257933|"~     This study hopes to determine the appropriate oral steroid dose for treating children~     hospitalized with asthma exacerbations. Practice guidelines from different countries~     recommend a wide range of doses, and the doses used in actual practice vary widely. There is~     no data on what is the most appropriate dose of prednisone (or equivalent) in this situation.~     We will be looking at the dose recommended by the National Asthma Education and Prevention~     Program guidelines, which are published by the National Heart, Lung, and Blood Institute, as~     compared with a lower dose which is commonly used in practice. We hypothesize that the lower~     dose will be no worse than the higher dose as determined primarily by duration of~     hospitalization.~   "
251650|NCT00257920|"~     The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol®~     Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on~     hemodialysis.~   "
251651|NCT00257907|"~     This study will examine how the immune system responds to infection with Mycobacterium~     tuberculosis bacteria (bacteria that cause tuberculosis) in order to better understand how~     the germ produces infection and how the immune response might work to control the infection.~      Only about one in 10 people infected by M. tuberculosis become sick, sometimes years or even~     decades after exposure. It is not known why some people become sick and most do not, but the~     immune system of people who never develop disease may be better able to control the bacteria.~     This study will evaluate the latent form of M. tuberculosis infection to further the~     understanding of the immune mechanisms - particularly the role of certain white blood cells -~     involved in the disease process.~      Healthy volunteers 18 years of age and older may be eligible for this study. Candidates are~     screened with a medical history, family history of medical conditions, sexual history,~     history of drug use, physical examination and blood tests, including a test for HIV. People~     in Mali, West Africa, and in local health clinics in the United States may participate.~      At the start of the study, participants have blood tests and a tuberculin skin test (PPD~     test), which indicates whether a person has been exposed to tuberculosis bacteria. For the~     PPD, a tiny amount of liquid containing dead tuberculosis antigen is put under the skin of~     the forearm with a needle. The antigen cannot cause infection or disease.~      After 3 days, participants have another blood test and the site of the tuberculin test is~     examined for swelling that would indicate a positive result. Participants with a positive PPD~     have a chest x-ray to check for tuberculosis disease. Those whose x-ray is also positive are~     withdrawn from the study and referred to their doctor for evaluation and treatment. Those~     whose x-ray is negative return to the clinic within 3 weeks of the tuberculin test to give~     another blood sample.~      Participants whose PPD is negative have a second tuberculin test 10 to 21 days later and~     return 3 days after the test to determine if it is still negative or if it is positive. (Some~     people who are negative after the first test may test positive after the second procedure.)~     Those whose test is still negative end their participation in the study at that time.~     Participants whose second PPD is positive have a chest x-ray as described above, and those~     with a negative chest x-ray return in 3 weeks to donate one last blood sample.~      The purpose of the present study is to evaluate the latent form of this infection, the~     prevalence of which worldwide exceeds that of active disease. Our hypothesis is that in~     latent tuberculosis antigen specific effector memory CD4+ T cells are responsible for the~     generation of clinically measurable delayed type hypersensitivity and that central memory~     CD4+T cells are not directly involved in this process. We base this idea on the assumption~     that latent tuberculosis is a state of antigen persistence and that effector memory T cells~     should be maintained as long as antigen/infection is present.~      We propose to conduct this study in Mali, West Africa and local clinics in the U.S.~     Tuberculosis affects 593/100,000(2) individuals in Mali and most have been exposed to the~     disease. Additionally it would be important to evaluate the same parameters locally as latent~     infection is one of the major factors for reactivation tuberculosis in this country. Patients~     would be enrolled in 4 major groups: HIV-/TST- (Group A), HIV-/TST+ (Group B), HIV+/TST+(G~     roup C) and HIV+/TST- (Group D).~      To evaluate this hypothesis we plan to enroll between 100 - 300 patients over the course of 2~     years from both countries. Blood samples before and at predetermined time points after the~     application of Purified Protein Derivative (PPD) will be obtained to determine the fraction~     of CD4+ T cells which produce interferon gamma in response to stimulation with PPD with a~     16hr antigen stimulation assay. Appropriate staining will be done to ascertain the phenotype~     as well as cytokine production (Interferon gamma,( IFN gamma), Interleukin 2 (IL2) and Tumour~     Necrosis Factor ( TNF)). Additionally lymphocyte proliferation will be studied using~     5-(and-6)-carboxyflouorescein diacetate succinimidyl ester (CFSE.)~      In conducting this study we hope to further the understanding of the immune mechanisms~     involved, particularly mechanisms of T cell memory, which would provide insights into TB and~     HIV pathogenesis. We also believe that understanding these mechanisms could lead towards~     establishment of surrogates for immunity in TB vaccine studies, which could enhance vaccine~     trial design. It might also help in understanding better the immunological dynamics of~     tuberculosis co-infection in individuals with HIV infection.~   "
251652|NCT00257894|"~     The purpose of this study is to determine whether baclofen is effective in reducing smoking~     urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.~   "
251653|NCT00257881|"~     The primary purpose of this study is to evaluate the safety, tolerability, and maximum~     tolerated dose (MTD) of CMD-193 administered intravenously (IV) to subjects with advanced~     malignant tumors. The secondary purpose is to obtain preliminary information on the~     pharmacokinetics and antitumor activity of IV CMD-193.~   "
251654|NCT00257868|"~     The purpose of this study is to determine whether Rivastigmine is effective for the~     prevention of postoperative delirium in patients undergoing cardiac surgery.~   "
251655|NCT00257855|"~     A present there is no safe treatment for reducing rate at which disability worsens in people~     with secondary progressive multiple sclerosis. Recent research has suggested the possibility~     that drugs that act by blocking the entry of sodium into nerve cells can protect nerve fibres~     in the brain and spinal cord. In this trial, the investigators will test whether one such~     drug, called lamotrigine, can prevent damage to nerve fibres and reduce the rate at which MS~     worsens. The period of treatment in the trial will run for 2 years.~   "
251671|NCT00257647|"~     Chronic myeloid leukemia is a serious disease which is characterized by progression from~     relatively quiescent stages of the disease to an aggressive phase. Although now there is~     highly successful medical therapy known as Gleevec (Imatinib), the treatment is not always~     successful and patients do develop resistance. Those patients have limited treatment options.~     We are developing a gene therapy model of treatment for this disease using pseudoviral~     particles to insert molecules of genetic material which would not allow the harmful genes~     causing the leukemia to function.~   "
251657|NCT00257829|"~     The Phenomenon of Tumor Hypoxia Many solid tumors are relatively resistant to treatment with~     ionizing radiation and certain chemotherapeutic agents such as anthracyclines that are~     affected adversely by acidic pH. These effects have primarily been attributed to the presence~     of hypoxic cells within the tumor. The relevance of hypoxia with respect to failure of~     radiotherapy to cure certain malignancies has had a chequered history. However, in recent~     years the evidence that hypoxia plays a central role in relative radioresistance has become~     more compelling.~      Since approximately two-thirds of all women suffering from cervical carcinoma receive~     radiation as a component of their therapy, an enhanced understanding of the interactions~     between hypoxia and radiation as a component of their therapy, an enhanced understanding of~     the interactions between hypoxia and radiation resistance is critical to improving outcome~     among those with cervical cancer.~   "
251658|NCT00257816|"~     There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in~     the United States in 2003 with about 4,000 deaths from this disease. This accounts for~     approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary~     treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant~     systemic cisplatin chemotherapy and radiation have shown high response rates (RR) with~     improvements in durable remissions and overall survival. Though the incidence and mortality~     in the U.S. dropped steadily from years 1940 to 2000, there has recently been a plateau,~     arresting the decline. With the routine addition of systemic Cisplatin (CDDP) chemotherapy to~     local regional radiation, mortality from advanced cervical cancer in the United States is~     expected to further decrease. However, further advances in this disease are needed.~   "
251659|NCT00257803|"~     Oxytocin is normally given either rapidly into the vein (bolus) or put into an intravenous~     bag and administered more slowly, after delivery of the baby by cesarean section. Both of~     these methods are commonly used. To date there has been little research to demonstrate that~     one method of giving oxytocin is better than another in women who are more likely to bleed~     after delivery. The purpose of the study is to see whether a small bolus of oxytocin makes~     the uterus contract better to reduce bleeding and decreases the need to give additional~     oxytocin or more powerful drugs in women who are at risk for bleeding after delivery of their~     baby by cesarean section.~   "
251660|NCT00257790|"~     Evaluate if tobramycin given once a day is at least as efficacious as the traditional~     tobramycin given three times a day, given with penicillin G, til patients with febrile~     neutropenia.~   "
251661|NCT00257777|"~     Controversies still exists concerning the overall clinical effects of blood-based vs.~     crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest.~     Both techniques are used world-wide. No larger prospectively randomized studies comparing the~     two methods have been reported. The aim of this study is to collect a large number of~     clinical data to create a proper basis for evaluation of the two techniques.~   "
251662|NCT00257764|"~     Swallowing dysfunction after stroke is common, but there is no reliable evidence for how it~     should be managed other than perhaps by nasogastric tube. This study compared the~     effectiveness of standardised, low and high intensity behavioral intervention for dysphagia~     with that of “usual care”.~   "
251663|NCT00257751|"~     Clopidogrel (Plavix), a platelet ADP receptor antagonist, has become the standard of care to~     prevent thrombosis in interventional cardiology and is increasingly being used in unstable~     angina and NSTEMI. An increasing number of patients are referred to emergent or urgent CABG,~     and several studies, as well as our own experience, have shown that preoperative~     administration of irreversible platelets inhibitors increase the risk of bleeding~     complications following CABG.~   "
251664|NCT00257738|"~     Squamous Cell Carcinoma of the Head and Neck (SCCHN) is a devastating illness, the treatment~     of which is associated with significant morbidity. This type of cancer affects 43,000~     individuals each year with an estimated survival rate of 50%. A potential treatment~     alternative for this patient population is the use of peptide-based immunotherapy. This~     clinical tial will be using a vaccines comprised on the Trojan peptides MAGE-A3 and HPV 16 to~     treat patients with Squamous Cell Carcinoma of the Head and Neck who have recurrent,~     progressive or metastatic SCCHN.~   "
251665|NCT00257725|"~     This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in~     4-to-5-year olds.~   "
251666|NCT00257712|"~     The purpose of the SMART study was to better understand whether the body's own production of~     growth hormone (GH) would improve memory and problem solving ability, or cognitive function.~     The study was a double blind, placebo-controlled study of the cognitive effects of growth~     hormone releasing hormone (GHRH) in healthy older men and women and in those with mild~     cognitive impairment (MCI).~   "
251667|NCT00257699|"~     Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the~     digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea,~     vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow~     structure due to scar tissue and swelling), and fistulae (abnormal passages from the~     intestines to another organ or to the skin).~      CD is thought to arise from a combination of inherited (genetic) factors and some undefined~     environmental factor(s). One environmental factor that has been shown to be intimately~     involved with the development of CD is the presence of bacteria that normally inhabit the~     intestines. As a result, some physicians have tried to alter the normal bacterial population~     as a means of controlling the inflammation (swelling) in the intestines of individuals with~     CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin.~     These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria~     that can contribute to chronic inflammation. More investigation is needed to firmly establish~     the usefulness of this therapy because previous clinical trials have given mixed results,~     although they have suggested that antibiotics can be particularly useful in cases of Crohn's~     colitis (CD that primarily affects the large intestine). Because these earlier studies have~     lacked a large enough patient population with colonic involvement, a trial focusing on this~     CD subgroup with a sufficient number of subjects will help to clarify the value of combining~     metronidazole and ciprofloxacin.~      The proposed study will test the hypothesis that combination antibiotic therapy is effective~     in the treatment of CD involving the colon. The study will compare the use of combination~     therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will~     examine the results of treatment at the end of 8 weeks of treatment.~   "
251668|NCT00257686|"~     The purpose of this study is to compare the efficacy and safety of pitavastatin with that of~     pravastatin in elderly patients~   "
251669|NCT00257673|"~     The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe~     and effective treatment for patients with mild to moderate Alzheimer's disease.~   "
251670|NCT00257660|"~     The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport~     manufactured at a new manufacturing facility in Europe.~   "
251672|NCT00257634|"~     The purpose of this project is to compare different treatment options for lateral~     epicondylitis. Lateral epicondylitis is a pain condition involving extensor muscles fo the~     forearm originating from the lateral epicondyle. Controversy exists regarding the method of~     delivering pain relief so that conditioning and strengthening can be initiated and progress~     appropriately. Our hypothesis is that the steady even delivery via iontophoresis (compared to~     injection will provide better pain control and allow physical therapy to progress more~     effectively.~   "
251673|NCT00257621|"~     This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in~     combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI)~     backbone. This study has a 48 week duration and is open to both treatment naive and~     experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.~   "
251674|NCT00257608|"~     This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the~     safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus~     bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.~   "
251675|NCT00257595|"~     To assess the safety of long-term use of cetirizine dry syrup in children with perennial~     allergic rhinitis.~   "
251676|NCT00257582|"~     To assess the safety of long-term use of cetirizine dry syrup in children with various type~     of cutaneous disease accompanied on pruritus.~   "
251677|NCT00257569|"~     To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of~     pruritus of the treatment period.~   "
251678|NCT00257556|"~     Prospective open label, randomised, parallel group, comparative pilot.~   "
251679|NCT00257543|"~     We hope to gain valuable information about the safety, success of engraftment, and rates of~     complications using alternate donor transplantation for children with severe SCD. Crucial~     information will be also collected about late effects from alternate donor BMT sickle cell,~     providing valuable information to clinicians and families making decisions among~     interventions for children with severe sickle cell disease. If successful, alternate donor~     transplantation in this setting could pave the way to offering curative treatment to many~     more patients with severe SCD.~   "
251680|NCT00257530|"~     This study will test whether addition of imiquimod to standard antimony therapy provides a~     significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our~     previous results, we hypothesize that lesions in patients who receive the combined treatment~     of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and~     produce less scarring than treatment with pentavalent antimony alone.~   "
251681|NCT00257517|"~     This study will assess 75-100 patients for feeding issues following surgery for single~     ventricle.~   "
251682|NCT00257504|"~     The purpose of the study is to test whether hypotensive episodes during dialysis - caused by~     withdrawal of fluid drom the circulation - can be predicted by means of two harmless~     monitoring techniques.~   "
251683|NCT00257491|"~     To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80~     mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential~     hypertension.~   "
251684|NCT00257478|"~     A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously~     treated with chemotherapy.~   "
251685|NCT00257465|"~     The purpose of this study is to determine whether a vaccine composed of patients' own~     melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and~     stimulates an immune response to patients' own cancer cells.~   "
251686|NCT00257452|"~     To demonstrate that tiotropium (Spiriva®) does not prolong the QT interval of the ECG more~     than placebo~   "
251687|NCT00257439|"~     The purpose of this study is to evaluate the urinary excretion and renal metabolism of~     vitamins, in particular vitamin B12 and folate, in relation to various renal conditions~     involving loss of renal function and/or proteinuria.~   "
251688|NCT00257426|"~     RATIONALE: Octreotide may stop or slow the growth of tumor cells and may be an effective~     treatment for liver cancer.~      PURPOSE: This phase II trial is studying how well octreotide works in treating patients with~     locally advanced or metastatic liver cancer.~   "
251689|NCT00257413|"~     Experimental data suggest that transplantation of endothelial progenitor cells (EPCs)~     attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition,~     clinical studies suggest that autogolous progenitor cells transplantation is feasible and~     safe in patients with ischemic disease. This study will investigate the feasibility, safety,~     and initial clinical outcome of intravenous infusion of autologous EPCs in patients with~     idiopathic pulmonary arterial hypertension.~   "
251690|NCT00257400|"~     This study will compare the effectiveness of individual versus interpersonal psychotherapy in~     treating depressed women with a history of sexual abuse.~   "
251691|NCT00257387|"~     Evaluate the incidence of acute rejection at 12 months after transplantation in subjects~     receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by~     CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune~     followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.~   "
251692|NCT00257374|"~     Background: Pedialyte and Gatorade are advocated for the treatment of dehydration in viral~     gastroenteritis, but there is limited evidence to support their use.~      Objective: To examine the efficacy, safety and palatability of Pedialyte, Gatorade, and a New~     Oral Rehydration Solution (NS).~      Design: Randomized double blind. Setting: Inpatient, community hospital.~     Patients/Interventions: 75 consecutive adult patients (m/f=44/33) admitted with viral~     gastroenteritis were randomized to receive Gatorade, Pedialyte or NS for 48 hours. A~     yogurt/rice diet was allowed ad libitum.~      Measurements: Stool and urine output, electrolytes, fluid intake, body weight, hematocrit and~     palatability of solutions.~      Limitations: Smaller sample size and higher drop out (20%).~   "
251693|NCT00257361|"~     We propose to undertake an initial study of DCS to determine whether it has any short-term~     clinical benefits when added to standard ERP therapy in adults with OCD.~   "
252306|NCT00249223|"~     The primary purpose of the study is to show that treatment with an injectable formulation of~     risperidone is not less effective than and has a similar safety profile to risperidone~     tablets in patients with chronic schizophrenia.~   "
251694|NCT00257348|"~     The purpose of the study is to evaluate the effectiveness and side effects of the drugs~     capecitabine and docetaxel in the treatment of cervical cancer. Capecitabine is approved by~     the FDA for the treatment of breast and colon cancer. Docetaxel is approved in the treatment~     of breast and lung cancer. The use of capecitabine and docetaxel in this study for the~     treatment of cervical cancer is considered investigational. Eligible subjects will take the~     drug capecitabine (Xeloda) by mouth twice a day every 12 hours, for fourteen consecutive days~     followed by a 7 day rest period. Subjects will also receive the drug docetaxel (Taxotere)~     intravenously (in the vein) every three weeks.~   "
251695|NCT00257335|"~     To demonstrate safety and efficacy of intensity-modulated radiotherapy (IMRT) for treatment~     of previously irradiated recurrent head and neck cancer.~      Specific Aims: Identify acute and late toxicities, response rates, locoregional control,~     disease free survival, and overall survival with IMRT. Also, tumor response, the amount of~     tumor shrinkage or reduction, will be analyzed.~      Rationale: Recurrent head and neck cancer is regarded as having limited treatment modalities~     since salvage surgery can only be accomplished on limited subgroups of patients. Chemotherapy~     has not shown clear clinical benefits and has significant toxicity. Re-irradiation has been~     used as a treatment modality. However, the re-irradiation dose is limited by significant~     toxicity that occurs with the cumulative dose of radiation. The use of IMRT can give a high~     dose to the recurrent tumor while limiting the dose to critical structures in the vicinity of~     the reirradiated volume thereby limiting toxicity and treating the recurrence to an adequate~     dose.~      The number of subjects was determined from 2 stage design with a historical control group as~     comparison, and these numbers of subjects were found to be 40.~      It is assumed that this treatment regimen will not be of further interest if the true~     response rate is less than 32.6% (Po0.326). It is also assumed that a true response rate of~     53% or more (P10.53) would be of considerable interest in the treatment of recurrent head and~     neck cancer. The type I error (the probability of rejecting the hypothesis that the~     proportion responding to the treatment is less than or equal to Po when this hypothesis is~     actually true) is 0.05.~   "
251696|NCT00257322|"~     While new treatments for metastatic and recurrent colorectal cancer have become available~     over the past several years, this disease remains incurable with a limited life expectancy~     from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer~     are needed. Under this proposal, patients with advanced colorectal cancer will receive~     Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic~     cells and enhance anti-tumor immune mechanisms. This will be combined with standard~     chemotherapy and patients will be followed for response and overall survival. Detailed~     correlative laboratory analysis will also be performed to define the extent of dendritic cell~     and cellular immune system stimulation.~   "
251697|NCT00257309|"~     General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of~     thrombolytic therapy (TT) for the treatment of AMI in patients >=75 years old with ST-segment~     elevation or LBBB AMI <6 hours of evolution without contraindications for TT.~      Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT~     in patients >=75 years old with AMI.~      Participating Centers: 27 Spanish hospitals performing >50 PA/year. Primary Endpoint (PE):~     Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30~     days. There are also 7 secondary endpoints (SE).~      Procedure: Diagnosis of inclusion/exclusion criteria --> Centralized randomization -->~     Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA~     within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months.~     Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days~     and 12 months. Quality control: 100% variable and follow-up review by external CRO. Safety~     Committee and Event Adjudication Committee formed by experts not participating in the study.~   "
251698|NCT00257296|"~     The purpose of the study is to evaluate a multi-faceted intimate partner violence (IPV)~     screening/intervention targeting abused women who are seen for prenatal care in~     obstetrics-gynecology clinics or general medical care in internal medicine clinics. The~     intervention is based on our clinical experience and review of the literature which suggests:~     1) IPV can vary and no one pattern exists for all women; 2) recovery from abuse usually~     occurs over time and not necessarily immediately after it is first detected; 3) women have~     gone down many different paths leading to an abusive relationship and there is no single path~     to recovery; 4) for screening/interventions to be credible and ultimately disseminated they~     must respond to the complexity of the patient stories clinicians see everyday when caring for~     women experiencing IPV and 5) busy obstetricians/internists/clinicians are unlikely to~     effectively screen and treat women experiencing IPV unless they are supported by other~     personnel trained to address IPV as well.~      The intervention also is based on recommendations of IPV experts and on the theory of chronic~     disease management that recognizes that the best outcomes are achieved when: 1) patients are~     educated and given the support and skills to set their own goals and make their own choices;~     2) multidisciplinary teams work better than programs focused only on physician behavior; 3)~     active monitoring of progress is essential; 4) active coping styles using a range of~     therapeutic modalities are available and 5) a stepped approach is utilized with those not~     making progress or with more severe problems receiving the greatest intensity of services.~      The screening/intervention will be available to each abused woman for approximately three to~     six months. Patients in the evaluation study will be surveyed at the following time points:~     baseline, 1 week, 1 month, 3 months, 6 months, and for the partial cohort that starts early,~     9 months. Additionally, a sample of nonabused women will be surveyed at baseline to serve as~     a referent group.~      Our primary hypotheses are, that compared to usual care, abused women receiving the~     intervention will have a reduction in levels of IPV, decreases in depression and nonspecific~     physical symptoms, increase in functional health status, increase in safety behaviors,~     increase in help seeking for issues related to IPV, and reduction of general medical~     services.~   "
251699|NCT00257283|"~     The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid~     ethyl ester 90) on the incidence of cardiovascular events and mortality in patients~     undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.~   "
251700|NCT00257270|"~     This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations:~     Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The~     hypothesis was that gabapentin would decrease both subjective and objective features of~     tinnitus in the trauma group, but would be less effective in the non-trauma group.`~   "
251701|NCT00257257|"~     Primary: Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes~      Secondary: Effect on glucose, insulin, C-peptide, insulin resistance, body weight,~     HDL-cholesterol, triglycerides, blood pressure - Safety, tolerability~   "
252028|NCT00252889|"~     The primary objective is to determine the nature and degree of the toxicity of weekly dosing~     of topotecan in escalating dose levels by cohorts of 3-6 patients in combination with a fixed~     dose of pegylated liposomal doxorubicin (Doxil).~      The secondary objective is to determine the activity of weekly topotecan and pegylated~     liposomal doxorubicin in advanced solid tumors.~   "
251702|NCT00257244|"~     The purpose of this study is to help improve our understanding of the biology involved in the~     body's response to serious trauma or burn injury. The host response to trauma and burns is a~     collection of physiological and pathophysiological processes that depend critically upon the~     regulation of the human innate immune system, with particular emphasis on the inflammatory~     component of that system. No single research center or small group of centers has the~     capacity to delineate the integrated response of this complex biological system, which~     involves multiple molecular and genetic interactions that vary in time. Our proposal promotes~     the identification of important dynamic relationships that regulate the integration of this~     complex biological system, with the expectation that this understanding will ultimately~     impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.~   "
251703|NCT00257231|"~     The purpose of this study is to help improve our understanding of the biology involved in the~     body's response to serious trauma or burn injury. The host response to trauma and burns is a~     collection of physiological and pathophysiological processes that depend critically upon the~     regulation of the human innate immune system, with particular emphasis on the inflammatory~     component of that system. No single research center or small group of centers has the~     capacity to delineate the integrated response of this complex biological system, which~     involves multiple molecular and genetic interactions that vary in time. Our proposal promotes~     the identification of important dynamic relationships that regulate the integration of this~     complex biological system, with the expectation that this understanding will ultimately~     impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.~   "
251704|NCT00257218|"~     OBJECTIVE – The role of health promotion for patients with impaired fasting glucose on~     preventing or delay the progression of diabetes mellitus has not been widely investigated in~     Taiwan. The purposes of this study are to explore the nature history of prediabetes, to~     evaluate the incidence of DM in prediabetes and to establish the cohort of people with~     prediabetes. Further study will be based on this cohort to evaluate the effect of health~     promotion and to compare the concentration of certain protein in their serum, such as~     adiponectin.~      RESEARCH DESIGN AND METHODS –A total of 600 subjects aged 40-60 years with impaired fasting~     glucose (100-125 mg/dl) were randomly selected from the Peng-Hu clinics during January 2003~     and December 2003. Anthropometric, biochemical, and metabolic characteristics will be~     measured, including weight, height, waist circumference, oral glucose tolerance test,~     triglyceride, high and low density cholesterol, blood pressure and insulin resistance etc. A~     questionnaire interviews with subjects regarding demographic characteristics is also~     performed. 300 subjects will receive education of health promotion. Simultaneously, 150~     subjects with normal fasting plasma glucose (<100 mg/dl) will selected for comparison.~      Statistical Analysis - Descriptive data will be described as means and SDs for continuous~     variables, and analysis of variance (ANOVA) and Chi-square tests were used for assessing the~     significances. Bonferroni method was used for post-hoc comparison in ANOVA. Multiple linear~     regressions were used for predicting determinants of FPG. We tested the variables scales in~     this study for multicollinearity by correlation matrix and VIF (variance inflation factor).~     Odds ratios (ORs) and the 95% confidence interval (CI) were calculated to estimate the~     relative risk of diabetes mellitus by logistic regression model. A p-value below 0.05 was~     considered significant. The statistical analyses were performed with SPSS statistical~     Package.~   "
251705|NCT00257205|"~     This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with~     surgically incurable metastatic melanoma who have received no prior chemotherapy, or~     biochemotherapy for the treatment of metastatic disease. The primary objective of this trial~     is to compare overall survival for patients with advanced melanoma who are randomized to~     receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or~     temozolomide (investigator choice)~   "
251706|NCT00257192|"~     The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective~     for the treatment of adolescents (ages 13-17) with schizophrenia~   "
251707|NCT00257179|"~     This study uses serum tissue factor and tissue factor inhibitor and factor VII to monitor the~     pre-coagulation status in lung cancer patients and to correlate the pre-coagulation status~     with clinical staging and prognosis.~   "
251708|NCT00257166|"~     The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective~     for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or~     mixed).~   "
251709|NCT00257153|"~     In patients with acute ST-segment elevation myocardial infarction (STEMI), percutaneous~     coronary intervention (PCI) may cause thrombus dislodgment and impaired microcirculatory~     reperfusion. This study was designed to test the hypothesis that thrombus aspiration before~     standard PCI may improve acute myocardial reperfusion, measured by ST-segment resolution~     (STR) and myocardial blush grade (MBG), compared with standard PCI.~   "
251710|NCT00257140|"~     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an~     antibiotic, compared with cefaclor, another antibiotic, in the treatment of adults with~     chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.~   "
251711|NCT00257127|"~     The purpose of this study is to determine immune system function following vaccination in~     HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior~     vaccination, patients in this study will receive booster shots of one of two pneumococcal~     vaccines, a hepatitis B vaccine, and a measles vaccine.~   "
251712|NCT00257114|"~     Multiple myeloma represents the second most common hematological malignancy.VELCADE is a~     small molecule to treat human malignancies. Its anti-neoplastic effect invovles several~     distinct mechanisms including inhibition of cell growth. Patients who have relapsed or are~     refractory to therapy, the standard of care is now VELCADE based on the results of previous~     clinical trials.~   "
251713|NCT00257101|"~     To test the effectiveness of a stepped-care intervention involving 2 stages: (1)~     Self-Telemonitoring (STM) of blood pressure (BP) which uses a telephone transmission system~     (2) Telephone-Based Nurse Case Management (NCM), provided by a commercially available~     service.~   "
251728|NCT00256906|"~     Isolated mild fetal ventriculomegaly is a common finding in fetal ultrasound examinations.~      When the ventricular diameter is more than 15 mm it is usually considered as severe and~     connected to other malformations. Most of these children will be severely affected later in~     life. Less than 10 mm ventricular width considered as normal.~      The current medical knowledge can not answer questions regarding future development of~     children who were diagnosed to suffer from mild (10-14.9 mm) brain ventriculomegaly during~     the pregnancy.~      We would like to assess the development and neurological status of all children who were~     diagnosed as mild ventriculomegaly during the pregnancy in the last 6 years and to~     prospectively follow up all the children who will be diagnosed from the beginning of the~     study on for 6 years.~      We hypothesized that the course of their development is different than of other children.~   "
251714|NCT00257088|"~     This five-year prevention services application is concerned with preventing substance abuse,~     comorbid mental and behavioral disorders, and school failure. We will direct an integrated~     set of first grade classroom based preventive interventions at two correlated and confirmed~     early antecedents: early aggressive, disruptive behavior and poor achievement. We will test a~     comprehensive Whole Day (WD) program directed at improving: 1) teacher's classroom behavior~     management; 2) family/classroom partnerships regarding homework and discipline; and 3)~     teacher's instructional practices regarding academic subjects, particularly reading. We will~     test WD effectiveness in a developmental epidemiological design in which children and~     teachers are randomly assigned to intervention and standard setting (control) classrooms in 2~     classrooms in each of 12 schools. While following the first grade children to the end of~     third grade, we will follow their first grade teachers over two subsequent cohorts of first~     graders to test whether the support and training structure sustains high levels of WD~     practice. We will also test whether the support and training structure is successful in~     training non-WD teachers. This prevention services aim will be augmented by an economic~     analysis of the costs and cost-effectiveness of the WD program. This combined services and~     prevention research should increase the efficiency of developing evidence-based programs and~     extending their use system-wide in both the prevention and education fields. The aims of our~     proposed work are to: 1) Implement and evaluate the effectiveness of a whole-day preventive~     intervention program for first-grade (WD) directed at known antecedent risk factors for later~     substance abuse, school failure, and comorbid mental and behavioral disorders; 2) Measure the~     variation in impact of WD due to variation in the experimentally manipulated quality of~     teachers' specific WD practices around classroom behavior management, family/classroom~     partnership, and quality of instruction, regarding reading, taking into account family, peer,~     and community factors; 3) Test effective- ness of the support structure required to sustain,~     and extend to other teachers high quality implementa- tion of WD; 4) Carry out economic~     analyses of the costs of implementing WD and their cost-effectiveness.~   "
251715|NCT00257075|"~     The purpose of the study is to assess the effectiveness and safety of risperidone (an~     antipsychotic medication) versus placebo during 3 weeks of treatment of mania in patients~     with Bipolar I Disorder who are suffering a manic episode.~   "
251716|NCT00257062|"~     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an~     antibiotic, compared with another antibiotic, ciprofloxacin, in the treatment of adults with~     uncomplicated infections of the skin and the supportive layers beneath the skin.~   "
251717|NCT00257049|"~     The purpose of this study is evaluation of the safety and effectiveness of levofloxacin, an~     antibiotic, compared with ceftriaxone sodium or cefuroxime axetil in the treatment of adults~     with pneumonia.~   "
251718|NCT00257036|"~     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an~     antibiotic, compared with ciprofloxacin, another antibiotic, in the treatment of adults with~     mild to moderate infections of the skin and the supportive layers beneath the skin.~   "
251719|NCT00257023|"~     The purpose of this study is to assess the safety, effectiveness, and plasma concentration of~     paliperidone (an antipsychotic medication) given once daily in the treatment of patients with~     schizophrenia~   "
251720|NCT00257010|"~     The purpose of this study is to evaluate the long-term safety of almotriptan malate (a~     migraine headache medication) in the treatment of migraine headaches in adolescents for up to~     one year.~   "
251721|NCT00256997|"~     The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic~     medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms~     of emotional instability, detachment from reality, often with delusions and hallucinations,~     and withdrawal into the self) participants with a history of being poorly compliant with~     taking their medication.~   "
251722|NCT00256984|"~     The primary purpose of this study is to determine how effective and how durable STARR~     (stapled transanal rectal resection) surgery is in relieving symptoms of intractable~     constipation associated with obstructive defecation syndrome (ODS).~   "
251723|NCT00256971|"~     The important role of the menisci in knee function and in preserving knee health has been~     shown in several studies. Additionally to principal functions of load transmission and shock~     absorption, meniscus contributes to knee joint proprioception and probably also to joint~     stability.Study about affect of meniscus injury on balance posture has not previously been~     published.Surgical practice is increasingly aimed at minimal resection of injured tissue,~     preserving a stable meniscal remnant with as much function as possible.The purpose of this~     study is to determine whether menisci surgery have any effects on relatively new postural~     control measures, in correlation with functional balance assessment. The second purpose is to~     establish the affect of different types of menisci surgery on balance impairment~     (meniscectomy vs tear repair), in correlation with a long-term outcome.~   "
251724|NCT00256958|"~     Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal complaints worldwide,~     affecting 30-40% of the population by the age of 65 yr.Individuals with knee OA suffer~     progressive loss of function.Balance is an integral component of these and many other~     activities of daily living. Individuals with knee OA display impairment in postural control,~     mostly under dynamic testing condition. Total knee replacement (TKR) has an established place~     in the treatment of knee osteoarthritis and is considered to be an effective intervention.It~     remains unknown whether TKR impact significantly at balance state of the patients with OA and~     whether improving in functional abilities after TKR correlates with balance control ability~     in this population.The purpose of this study is to determine whether TKR have any effects on~     relatively new postural control measures using force platform system - Balance master, in~     correlation with functional balance assessment.~      Methods:~      Participants During a year of prospective study we plan to recruit 150 participants with~     symptomatic OA of the knee, hospitalizing in orthopedic department of Hadassah Hospital for~     primary TKR. Participants will undergo evaluation just before a surgery and a year after.They~     will be asked to perform Balance Master measurements, ambulation and balance tests.~     Additional information will be collected through a questionnaire and physical examination.~   "
251725|NCT00256945|"~     In this study we intend to find out the pattern of biofilm accumulation in vivo on various~     surface finishings.~      Our intention is to prepare Polymethylmetacrylate squers on orthodontical brackets,then~     prepare the surface of the sample and measure the surface roughness with a profilimeter and~     get the mean value in Ra units, then place the brackets on lower premolars and molars for 12~     hours, remove them and examine the biofilm formed with confocal scanning microscope.~   "
251726|NCT00256932|"~     Adults who are taking opioid therapy for persistent non-cancer pain and have resulting~     opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or~     to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan~     with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on~     frequency of bowel movements. Subjects will be required to: (1) track their bowel movements~     and other bowel symptoms and (2) attend 6 clinic visits over 4 months.~   "
251727|NCT00256919|"~     This study is designed to compare a range of doses of GW856553 versus placebo on the~     biomarkers associated with rheumatoid arthritis~   "
251729|NCT00256893|"~     A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in~     particular the widespread pain associated with this condition. A total 160 subjects (80 per~     treatment arm) are being recruited from approximately 25 centres in 9 European countries.~     Male and female subjects greater than 18 years of age with a diagnosis of primary~     fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible~     for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon~     a statistically defined allocation to treatment. The primary endpoint is improvement in pain~     score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the~     subject's pain is being collected on a daily diary. In addition, the overall improvement in~     quality of life for the subject will be assessed by means of a number of subject-completed~     questionnaires during the treatment period. Safety of the treatment regimen will be assessed~     throughout the study.~   "
251730|NCT00256880|"~     The purpose of this study is to determine how effective and safe a new investigational drug~     is in treating patients with relapsed or refractory multiple myeloma. The treatment involves~     daily dosing. A patient may continue to receive the treatment as long as they are benefiting~     from the treatment. Blood samples will be taken at specific times to measure the amount of~     drug in your body at specific times after the drug is given. Blood samples will also be taken~     for lab tests such as complete blood counts and clinical chemistries. Physical exams will be~     performed before each treatment. During the treatment phase, the patients will undergo~     regular assessments for safety and clinical response.~   "
251731|NCT00256867|"~     This study evaluates the effect of medicines for type 2 diabetes and lipids control. This~     study will require about 6 office visits for lab tests and examinations. All study related~     medicines and medical examinations will be provided at no cost to the subjects.~   "
251732|NCT00256854|"~     This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed~     dose conversion recommendations for RLS subjects converting from ropinirole immediate release~     to ropinirole controlled-release for RLS.~   "
251733|NCT00256841|"~     The study is designed for patients with non small cell lung cancer whose cancer is too~     advanced and therefore cannot be operated with the goal of completely removing the cancer. At~     this stage of the disease, most patients cannot be cured from the disease, however, treatment~     can help to live longer and better by keeping the cancer under control. For that purpose,~     patients traditionally receive radiation therapy or chemotherapy or both treatments in~     succession. Recently, the administration of both treatment methods given concurrently showed~     somewhat better results when compared to successive administration. In some studies the drug~     Taxotere together with radiation performed well in keeping the cancer better under control.~      Combination of the drug Taxotere together with a compound called 5-FU either as continuous~     infusion or in its oral form of a pill called Xeloda enhanced its anti cancer activity~     substantially.~      One goal of this study is to investigate how much of the combination can be given in~     conjunction with chest radiation. Using X-rays, the study will also evaluate how much~     shrinkage of the cancer is caused by this treatment directly at the tumor site and other~     areas where the cancer may have also spread.~      In this study the radiation will be given on only one day per week in two sessions, rather~     than divided over five days per week (Monday through Friday) as it is more commonly used.~     However, both schedules have been found to be equally effective.~      The treatment program will use increasing doses of the 5-FU medication, either as infusion or~     as pill to find the highest dose that is tolerated. Once the highest tolerated dose is~     determined, subsequent patients who will be enrolled will continue to be treated at that dose~     level. The dose of the drug Taxotere will remain the same throughout.~      Hypothesis: Our previous research suggests that the combination of Taxotere and 5-FU given~     together with weekly chest radiation will provide a more convenient form of treatment than~     the conventional approach and also be at least similar in its efficacy.~   "
251734|NCT00256828|"~     The purpose of this study is to compare the antiviral activity of two treatment groups for~     HIV chronic infection: a QD regimen of didanosine, lamivudine and efavirenz versus a BID~     regimen of zidovudine, lamivudine and efavirenz. Both will be administered with food in the~     starting treatment of human immunodeficiency virus infection at Week 48.~   "
251735|NCT00256815|"~     The study is designed for subjects whose cancer is too advanced and therefore cannot be~     operated with the goal of completely removing the cancer. At this stage of the disease, most~     subjects cannot be cured from the disease, however, treatment can help subjects to live~     longer and better by keeping the cancer under control. All treatment offered to is primarily~     pursuing that goal. Subjects at this stage of their disease traditionally receive radiation~     therapy or chemotherapy, both treatments in succession or both concurrently. Recently, the~     administration of both methods of treatment concurrently has been employed and indicate~     somewhat better results. Specifically, a class of chemotherapy agents called Vinca Alakaloids~     used in combination with radiation therapy appear promising as determined in small studies.~     The drug Navelbine is part of this class of drugs. This drug is approved as an infusion~     through the veins. The pill form is under development and will be used in this form in this~     treatment program.~      For this protocol, radiation will be administered using a schedule which is more convenient~     for patients, by once weekly chest irradiation for a total of 12 weeks. Use of this schedule~     was determined to be as good as the more commonly used daily radiotherapy. The once weekly~     schedule is less cumbersome as it involves less visits. The rationale and reason why you are~     being asked to participate in this program is to study whether the drug Navelbine can be~     given together with the once weekly radiation schedule. Radiation will be administered in two~     fractions, 6 hours apart on one day. For this program, the drug Navelbine would be made~     available as a pill, and would not have to be infused through the vein. The proposed protocol~     will use increasing doses of the drug Navelbine in pill form to find the highest dose of~     Navelbine that is tolerated in conjunction with radiation therapy. Initially, each subject~     will receive one dose of Navelbine, which is higher than the dose of the previous subject.~     This escalation will continue until the highest tolerated dose has been determined.~      The administration via pill would be easier and avoid previously experienced side effects~     that were experienced by infusion into the veins of subjects, such as burning and sores at~     the infusion site.~   "
251736|NCT00256802|"~     To examine the ability of MRA to measure the effect of GTN on the intra-cranial vascular~     response during the GTN-induced headache in healthy volunteers.~   "
251749|NCT00256620|"~     The principal objective to this randomized trial is to compare the efficacy of two strategies~     of intra-operative hemodynamic management during cardiopulmonary bypass among patients~     undergoing primary elective coronary artery bypass graft (CABG) surgery in preventing~     peri-operative cardiac, cognitive and neurologic morbidity and mortality and post-operative~     deterioration in the patient's quality of life as measured by the seven domains of SF-36~     Health Survey (bodily pain, health perceptions, energy, and mental, physical, social and role~     function).~   "
251771|NCT00256334|"~     Resveratrol is purported to possess cancer preventive activity, especially for colon cancer,~     though its mechanisms of action are not well defined. Resveratrol is found in the skin of~     grapes and has anti-oxidative and pro-apoptotic effects on cancer cell lines in vitro. The~     main dietary sources of resveratrol are grapes, grape products, and red wine, and small~     amounts may be found in mulberries. A prior report and compelling preliminary data from our~     laboratory suggest that resveratrol modulates Wnt signaling, a signaling pathway which is~     activated in over 85% of colon cancers. In this proposal, studies were performed to define~     the actions of resveratrol on the Wnt signaling pathway in a clinical trial in which patients~     with colon cancer received treatment with Resveratrol, and correlative laboratory studies~     examined its effects directly on colon cancer and normal colonic mucosa. These studies~     provided data on the mechanisms of resveratrol action and provided a foundation for future~     prevention trials, correlative studies and therapeutic clinical research with this agent.~   "
251737|NCT00256789|"~     This program is designed for the treatment of patients with advanced non-small cell lung~     cancer. The study is designed for patients whose cancer is too advanced and therefore cannot~     be operated with the goal of completely removing the cancer. Patients at this stage of their~     disease traditionally receive radiation therapy or chemotherapy or both treatments in~     succession. Recently, the administration of both methods of treatment has been employed and~     preliminary studies indicate somewhat better results. Specifically, a new class of~     chemotherapy agents called taxanes used in combination with radiation therapy appear~     promising as determined in small studies. However, the best treatment for this type of cancer~     has not been established yet. One goal of this study is to investigate if the combination of~     the new drug Taxotere (a drug belonging to the taxane class) given on the day of the~     radiation is well tolerated and will result in enhanced shrinkage of the cancer compared to~     traditional radiation therapy. In this study the radiation will be given on one day, rather~     than divided over five days per week (Monday through Friday) as in previous studies. Previous~     research has shown that both equal in how effective they are in treating lung cancer. The~     study will use the drug Taxotere in conjunction with radiation therapy. Taxotere is an~     approved medicine by the United States Food and Drug Administration for the treatment of lung~     cancer.~      The purpose of this study is to evaluate if the chemotherapy drug Taxotere administered once~     weekly together with concurrent radiation on the same day is effective in shrinking non-small~     cell lung cancer. This trial will also investigate how well this treatment is tolerated and~     what effects this treatment will have on the everyday life and activities of participants.~   "
251738|NCT00256776|"~     This is an international study in adult patients diagnosed with multiple myeloma who have~     already received at least one autologous stem cell transplantation and who have responded but~     later progressed, or relapsed, at least one year after transplantation.~      Eligible patients will be randomly assigned to one of two treatments: either Velcade plus~     Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone.~      Thalidomide and Velcade are two new agents that have recently become available for the~     treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to~     test the hypothesis that the combination treatment with Velcade plus Thalidomide plus~     Dexamethasone will result in a longer time to progression (measure of time after the disease~     is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.~   "
251739|NCT00256750|"~     The purpose of this study is to learn if Belatacept can provide protection from organ~     rejection following kidney transplantation while avoiding some of the toxic effects of~     standard immunosuppressive medications such as kidney damage. Effects on kidney function and~     patient survival as well as drug safety will also be studied.~   "
251740|NCT00256737|"~     The purpose of this study is to study gastritis, GI symptoms during long term omeprazole~     treatment~   "
251741|NCT00256724|"~     The purpose of this study is to determine if the impedance threshold device (ITD) attached to~     a facemask can increase blood pressure in patients who present to the emergency department~     with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss,~     sepsis, or dehydration.~   "
251742|NCT00256711|"~     This is a randomized, open label, parallel group, multi-centre, phase II study of progression~     free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30~     mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with~     locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.~   "
251743|NCT00256698|"~     The purpose of this study is to determine the efficacy of anastrozole monotherapy versus~     maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared~     with in treatment of hormone receptor positive women with first relapse of breast cancer.~   "
251744|NCT00256685|"~     The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate~     (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with~     menopause, and also to assess the effects of DVS on sleep parameters and health outcomes~     indicators.~   "
251745|NCT00256672|"~     The purpose of this study is to determine whether full-time high dose prophylactic bracing~     (23 hours or more per day) is more effective than low dose bracing (12 hours or less per day)~     in preventing or delaying spinal curve progression in children with scoliosis after spinal~     cord injury.~   "
251746|NCT00256659|"~     To evaluate the utility of real time prognostic data (illness severity, stability and~     function) in the improvement of hospitalization morbidity, mortality, iatrogenic~     complications and length of stay.~   "
251747|NCT00256646|"~     OBJECTIVES: Vascular Disease is the leading cause of complications and death in patients with~     diabetes. Risk markers and underlying mechanisms have not been fully elucidated, and may~     differ from those in non-diabetic individuals. The unifying theme for the Program Project is~     that hyperglycemia and insulin resistance alter a number of biological processes which~     interact in vicious cycles to accelerate atherogenesis and are consequently major underlying~     risk factors for vascular disease. The overall objectives are to define these unique~     processes and to elucidate underlying biochemical, metabolic, and genetic determinants of~     vascular disease complications in diabetes.~      RESEARCH PLAN: Over the past 4 years, we have collaborated with the DCCT/EDIC Study Group,~     and have made novel observations regarding vascular disease pathogenesis in Type 1 Diabetes.~     This work has focused our studies on specific pathogenic processes. We will now study a Type~     2 Diabetes cohort from the VA Cooperative Study, Glycemic Control and the Complications of~     Diabetes, Type 2, with high vascular disease event rates. These collaborations provide a~     unique opportunity to address the pathogenesis of accelerated atherogenesis in the two main~     types of diabetes, and will greatly augment the scientific knowledge that will be gained in~     the conduct of these world-class prospective trials.~      METHODS: The Program Project has 4 projects and 3 cores. Project 1 will assess lipoproteins,~     glycoxidative stress, and inflammation as risk factors in studies involving Type 2 Diabetes~     patients and cultured cell systems. Based on preliminary data from our initial studies Type 1~     patients, changes in the NMR lipoprotein subclass profile will be emphasized.~      Project 2 will elucidate interactions between inflammation, modifications of lipoproteins,~     and autoimmunity in vascular disease risk. These novel concepts are also based upon exciting~     preliminary data pertaining to LDL-antibody complexes.~      Project 3 will pursue interesting preliminary data and define the role of the~     kallikrein-kinin system in vascular disease complications, with effects on mitogenesis and~     matrix production.~      Project 4 will assess the role of the Insulin Resistance Syndrome and novel factors secreted~     from adipocytes in the pathophysiology of biochemical risk factors and cardiovascular~     complications.~      Cores include an Administrative Core, a Biostatistics and Epidemiology Core which will link~     with the trials data coordinating centers, and Molecular and Statistical Genetics Core.~     Investigators will work in close collaboration with the VA Executive Committee, Study~     Centers, the Hines Coordinating Center, and some of the other ancillary studies. All data~     analysis involving clinical outcomes will be performed at the Hines Coordinating Center.~      There is true synergism among the projects at both scientific and logistical levels. The~     Program Project design allows for interactions among multidisciplinary investigators studying~     the same cohort, which will define how multiple pathological processes interact at the level~     of the arterial wall to promote atherosclerosis.~   "
251748|NCT00256633|"~     TITLE: CSP 465-C, Fatty Acid Binding protein 2 (FABP2) ancillary proposal to CSP# 465~     Glycemic Control and Complications in Diabetes Mellitus Type 2.~      Angeliki Georgopoulos, M.D. Carlos Abraira M.D. William Duckworth M.D.~      Fatty acid binding protein 2 (FABP2) is involved in the transport of long chain fatty acids~     across the intestinal epithelium. A common (40-45%) polymorphism of FABP2 gene (codon 54~     Threonine for Alanine) results in increased intestinal fatty acid absorption and triglyceride~     secretion (Baier et al J Clin Invest 95:1281-87, 1995; Baier et al J Biol Chem 271:~     10892-10896,1996). We have found (JCEM 85:3155-60, 2000) that in patients with type 2~     diabetes, the codon 54 polymorphism of the FABP2 results in fasting and postprandial~     hypertriglyceridemia. Since hypertriglyceridemia is a risk factor for atherosclerosis in type~     2 diabetes and it is part of the insulin resistance syndrome, the objective of this ancillary~     study would be to screen the participants of the CSP# 465 study for the polymorphism and~     assess a) whether those carrying the polymorphism respond differently to the various~     treatment modalities and b) whether they develop more cardiovascular events compared to the~     ones lacking the polymorphism. There is one study that suggests an association of the~     polymorphism with a history of parental stroke (JCEM 85:2801-4, 2000).~      The only additional request from the study participants will be to agree to the collection of~     a blood sample to be used for DNA isolation and screening for the polymorphism. No additional~     funds are requested. If this polymorphism proves to be a predictor of either the response to~     a specific treatment modality or of the risk to macro-vascular complications, it will be very~     easy to screen for it and target our treatment modalities appropriately.~   "
252307|NCT00249210|"~     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an~     antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with~     rapid onset of severe inflammation/infection of the sinuses.~   "
251750|NCT00256607|"~     A predominant consequence of diabetes mellitus (DM) type 2 is accelerated development of~     atherosclerosis related conditions. Conventional cardiovascular risk factors only explain a~     portion of the excess risk for atherosclerosis in this population. In vitro, animal and~     epidemiologic studies have suggested that a variety of novel cardiovascular risk factors~     (CVRF), including triglyceride-rich lipoproteins (TGRL), small dense low density lipoprotein~     (D-LDL) subfractions, oxidative stress, and advanced glycation endproduct (AGE) formation may~     contribute to the development of atherosclerosis. These risk factors may also induce~     endothelial cell activation/injury or local or systemic inflammation that cause elevations in~     plasma levels of additional novel risk factors, such as soluble adhesion molecules,~     plasminogen activator inhibitor-1 (PAI-1), fibrinogen and C-reactive protein (CRP). Many of~     these risk factors are increased in DM type 2, presumably as a consequence of hyperglycemia~     and insulin resistance. However, no studies have evaluated the singular or synergistic~     relationship of these novel (CVRF) to measures of atherosclerosis as well as to the~     development of clinical macrovascular events in individuals with diabetes. If, as we suspect,~     these novel CVRF are related to development of atherosclerosis and macrovascular disease, it~     will be critical for the future design of prevention strategies to know whether intensive~     glucose lowering significantly reduces the levels of these novel CVRF. Furthermore, it would~     be important to explore whether the relationship of the above novel risk factors to~     atherosclerosis and development of clinical events is attenuated in those individuals~     receiving glucose lowering therapy. Alternatively, if glucose lowering has no effect (or a~     negative effect), on relevant novel CVRF, this could potentially explain the limited success~     of intensive glucose lowering to reduce macrovascular events in several prior trials.~      The investigator proposes to take advantage of the study population and framework of the~     recently approved VA Cooperative Study of Glycemic Control and Complications in Diabetes~     Mellitus Type 2 to address these issues in an efficient and cost-effective manner.~   "
251751|NCT00256594|"~     The purpose of this study is to determine if a modified paper prescribing form decreases~     prescribing errors compared to a traditional or standard paper prescribing form.~   "
251752|NCT00256581|"~     Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and~     new camera.~   "
251753|NCT00256568|"~     The purpose of this study is to better understand outpatient prescribing errors through~     clinic and pharmacy-based error reporting systems.~   "
251754|NCT00256555|"~     Cystic fibrosis (CF) is a catabolic condition, and children affected with this disease~     frequently have problems with growth, despite adequate nutrition. We hypothesize that the~     anabolic effects of growth hormone (GH) will improve the height and weight of CF patients and~     thereby improve their clinical status and their quality of life. We further hypothesize that~     these effects will be sustained for at least one year after GH treatment is complete.~   "
251755|NCT00256542|"~     The purpose of this study is to determine whether intravesical U101 (alkalinized~     lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder~     origin.~   "
251756|NCT00256529|"~     This is a prospective descriptive cross sectional study to determine the percentage of~     patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and~     to establish which presenting factors warrant esophageal biopsies. We hypothesize that a~     greater than expected percentage of patients who are biopsies will have histologic changes~     consistent with EE.~   "
251757|NCT00256516|"~     Exchange of the butter, eggs, cheese and meat in the Atkins diet for soy protein foods, other~     vegetable proteins including gluten and vegetable fats, nuts, avocado, olive and canola oil~     will result in dramatic rather than modest reductions in blood lipids with weight loss. In~     effect this will represent an exchange of saturated fat and animal protein for healthy~     monounsaturated and polyunsaturated fats and vegetable proteins with significant effects on~     blood lipids while still encouraging weight loss.~   "
251758|NCT00256503|"~     About 10% of the population is believed to suffer from Primary Insomnia. It is also believed~     that people with chronic insomnia have a sleep system that is essentially out of alignment~     (we call this homeostatic dysregulation). We also know that a certain form of~     non-medication therapy called cognitive-behavioral therapy is a very effective treatment for~     insomnia. It is not known, however, whether cognitive-behavioral therapy actually works by~     bringing the brain's sleep system back into alignment (sleep homeostasis). One of the~     methods used to measure sleep homeostasis is to observe a person's brain waves during sleep~     and particularly during sleep that follows a period of sleep loss.~      The purposes of this study are to first learn whether persons with insomnia do have a~     misaligned sleep system compared to persons who do not have insomnia by assessing the sleep~     of people before and after a period of extended sleep loss. Second, the study will determine~     whether cognitive-behavioral therapy can re-regulate the sleep system and its response to~     sleep loss. Third, the final purpose is to examine whether the immune system of people with~     insomnia is more altered following sleep loss than in the comparison group and whether~     cognitive-behavioral therapy can alter immune function.~   "
251759|NCT00256490|"~     Patients affected with non-Hodgkin’s large B-cell lymphoma are treated by chemotherapy. The~     evaluation of the response to this treatment is made by Positron Emission Tomography (PET/CT)~     in many centres where this technology is available. Presently PET scans and CT scans are~     being performed before treatment, after 4 cycles of chemotherapy and a few months after the~     end of treatment.~      The goal of this study is to determine if it is possible to evaluate the efficiency of~     chemotherapy treatments after one cycle of treatment instead of waiting after 4 cycles, using~     a new scanner that combines PET and CT modalities. Data available from studies on these~     combined exams suggest that PET/CT helps to rapidly evaluate the response of the chemotherapy~     treatment. We also want to verify if some pathological characteristics measured from tumor~     cells will enable doctors to predict in advance the response to treatment.~   "
251760|NCT00256477|"~     The main aim of this project is to evaluate the use of a specific Yoga technique of~     controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This~     method is currently the subject of a United States grant application to formally test~     American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with~     The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this~     course for treatment of American veterans returning from Afghanistan and Iraq. Elements of~     this method have been used on a variety of populations. Whilst this is a multi-component~     intervention, it is postulated that the most active ingredient in the program is a specific~     Yoga breathing technique called Sudarshan Kriya (SK).~   "
251778|NCT00256243|"~     We proposed to use 4 cycles of AC q 2 weeks, as used in the dose dense adjuvant study with~     GM-CSF support on days 3-9 of the cycle. After the completion of AC we plan to administer~     paclitaxel and carboplatin weekly for a total of 12 doses with one week rest after every 3~     weeks of treatment over 12 weeks. Patients who are her-2 over-expressors by FISH~     (fluorescence in situ hybridization) will also receive Trastuzumab with weekly carboplatin~     and paclitaxel as the combination TC±H has been found to be synergistic in advanced breast~     cancer with improved clinical outcome.~   "
251761|NCT00256464|"~     The principal aim of this project is to conduct a Randomized Controlled Trial (RCT) to~     examine whether adding a twelve-session Multi-Component Yoga Intervention (MCYI) to the~     treatment regimen of Australian Vietnam Veterans suffering chronic Posttraumatic Stress~     Disorder (PTSD) leads to a significantly greater clinical improvement than conventional~     psychiatric treatment alone. Include 12 sessions with each session 3 hours duration- 4 days~     per week for 3 weeks i.e. total of 36 hours. The Multi-Component Yoga Intervention (MCYI)~     consisting of specific poses, breathing techniques, information about yoga techniques and~     practices, group processes, psychoeducation, relaxation procedures and meditation techniques~     in Vietnam War Veterans with chronic Posttraumatic Stress Disorder (PTSD) resistant to~     treatment has been developed. This project aims to evaluate MCYI through RCT method.~      It is hypothesised that Yoga augmentation will lead to: (1) reduced symptoms of PTSD and~     Depression; and (2) reduced alcohol intake. A secondary aim of the proposed RCT is to~     evaluate putative mediating variables. Benefits include that it is low cost and easy to~     apply. Done at home, non threatening and additional to standard psychiatric treatment for~     PTSD.~   "
251762|NCT00256451|"~     The purpose of the study is to understand the relationship between what an individual~     inherited from their family (genetics), how they respond and feel after drinking alcohol, and~     how they respond to pre-treatment with naltrexone, a medication that blocks some of the~     effects of alcohol and is approved for the treatment of alcoholism. The investigators are~     conducting this study on those of African descent because there is almost no research focused~     on this group and the association with genetics. The investigators seek to enroll 40 people~     in the study. Participation will consist of 4 different alcohol challenge sessions. Each~     session will be separated by at least 10 days. In total, there will be four challenge~     sessions.~   "
251763|NCT00256438|"~     Transcranial direct current stimulation (tDCS)is a non invasive technique which uses a very~     weak current to change excitability in targeted regions of the brain. Early studies suggest~     that it has antidepressant properties. This study will test the safety and efficacy of tDCS~     as a treatment for depression.~   "
251764|NCT00256425|"~     The purpose of this study is to determine whether cognitive rehabilitation is effective in~     patients with gliomas (brain tumour), by comparing direct and follow-up neuropsychological~     functioning and quality of life of the experimental group to the control group.~   "
251765|NCT00256412|"~     This is a research study to determine whether omega-3 fatty acid supplementation, when taken~     with the antidepressant medication escitalopram (Lexapro), helps to improve depressive~     symptoms in individuals who have major depressive disorder (MDD).~      Omega-3 fatty acids are found in foods including walnuts, some fruits and vegetables, and~     coldwater fish such as herring, mackerel, sturgeon, and anchovies.~   "
251766|NCT00256399|"~     Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in~     males with BPH and ED.~   "
251767|NCT00256386|"~     Errors and preventable adverse events associated with medication prescription and dispensing~     are common, and the difference between guideline recommendations and the actual frequency of~     laboratory monitoring is substantial. This study evaluates three interventions to improve~     laboratory monitoring at initiation of medication therapy: an electronic medical record~     reminder to the prescribing clinician (EMR), an automated voice message to the patient (AVM),~     and a pharmacy team outreach (Pharmacy) compared to usual care (UC).~   "
251768|NCT00256373|"~     Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP)~     can be improved. At present patients with LBP start treatment as soon as possible, this also~     applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At~     Glostrup University Hospital department of Physical Medicine/rheumatology we use a method~     (method A) where an interdisciplinary team gives the patients a treatment composed of various~     topics. This includes among other things education, physical team training, exercises in~     swimming pool, stretching exercises, and occupational therapy. A different method (method B)~     originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus~     strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the~     beginning partly carries the patient through the exercises, assists this training.~      In both methods, individually considerations are taken, but to a greater extend in method B.~     The treatment will extend over a three months period.~      A few earlier investigations have compared these two methods, but they have not been~     systematized to such a degree, that they gave any final conclusions. Therefore, we~     initialized an investigation including a larger number of patients, where the two methods are~     compared from the results the patients achieve after 3, 6, 12 and 24 months.~      286 consecutive patients were included and randomized to one of the two methods. Those, who~     did not wish to participate in the investigation, were treated according to the department’s~     normal procedure (Method A)~   "
251769|NCT00256360|"~     The rationale of this randomized phase II study is to investigate the feasibility of~     sequenced densified FEC and docetaxel based regimens in patients with primary operable~     high-risk breast cancer. Several phase III and phase II clinical trials showed the benefits~     of dose-dense therapy (Q2W) over conventional treatment in breast cancer, lymphoma and SCLC.~     The aim of the study is also to demonstrate that further shortening of treatment interval~     from 14 days to 10-11 days in FEC regimen is feasible and will not compromise patient's~     safety. The results of this randomized phase II study should serve as a basis for follow-up~     randomized phase III trial comparing conventional versus densified sequential FEC and~     docetaxel based regimens.~   "
251770|NCT00256347|"~     30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a~     screening/orientation session. The next 5 visits will be (full day) outpatient sessions~     taking place Monday through Friday during one week. All full day visits will be drug~     administration sessions with subjects randomized to one of two groups. The primary purpose is~     to investigate the time course of development of analgesic tolerance (loss of pain relieving~     effect) to morphine on experimentally produced skin tenderness in healthy volunteers.~   "
251793|NCT00256048|"~     The purpose of this study is to determine if naso-jejunal feeding (feeding beyond the~     stomach) improves the efficacy of enteral feeding (feeding into the gut) in critically ill~     patients.~      The study hypothesis is that in patients who fail to establish enteral feeding via the~     nasogastric route, introduction of nasojejunal feeding will lead to more effective enteral~     feeding than the current regime involving staged introduction of promotility agents.~   "
251772|NCT00256321|"~     Gastric cancer is the second most common neoplasm in the world. Early diagnosis and surgical~     resection improve the survival and the chance of cure. Unfortunately, majority of cases are~     diagnosed at advanced stage, with only 20% of the patients presenting with localized disease.~     The five-year survival for gastric cancer of all stages remains at a dismal 8%. Chemotherapy~     has been used for advanced gastric cancer but with unsatisfactory results. Therefore, new~     approaches are needed for these patients. Among the newer chemotherapy regimens for advanced~     gastric cancer include a combination of oral 5FU-based compound called Capecitabine(Xeloda)~     and Oxaliplatin. A few phase II studies suggest that the combination regimen is active with~     overall response rates ranging 30-40%. Several preclinical and clinical studies have shown~     that the expression of cyclooxygenase enzyme II(COX-2) is upregulated in many pre-neoplastic~     and neoplastic lesions. Furthermore, there appears to be an association with the~     overexpression of Cox-2 and the invasiveness of cancer and prognosis. Finally, preclinical~     and clinical studies suggest selective Cox-2 inhibitors can induce apoptosis in gastric~     cancer cells and retard tumor progression. Therefore, there is a strong rationale for the~     combination of a selective Cox-2 inhibitor, Celecoxib, with Capecitabine and Oxaliplatin in a~     therapeutic phase II trial for patients with advanced or recurrent gastric cancer.~   "
251773|NCT00256308|"~     Oxaliplatin-containing regimens have been safely and successfully used in combination with~     concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The~     Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5-fluorouracil~     (5-FU) and radiation in the treatment of rectal cancer. The trial showed a combined~     preoperative chemoradiotherapy and Oxaliplatin-containing regimen is well tolerated with no~     increase surgical toxicity. The good response rate observed warrants its use in further~     clinical trials.~      The combination of oxaliplatin, 5-FU, and radiation also have been used in a Phase I/II trial~     in esophageal cancer. In this particular trial, eligibility included therapeutically naïve~     esophageal cancer subjects with clinical disease stages II to IV. Initial doses and schedules~     for cycle 1 consisted of Oxaliplatin 85 mg/m2 on days 1, 15, and 29; continuous infusion of~     5-FU 180 mg/m2 for 24 hours for 35 days; and radiation therapy (RT) 1.8 Gy in 28 fractions~     starting on day 8. At completion of cycle 1, eligible subjects could undergo an operation or~     begin cycle 2 without RT. Postoperative subjects were eligible for cycle 2. Stage IV subjects~     were allowed three cycles in the absence of disease progression. 38 subjects were treated (22~     stage IV, 16 stage II-III). 38 eligible subjects received therapy: 22 non-invasively staged~     as IV and 16 non-invasively staged as IV and 16 non-invasively staged as II and III. 36~     subjects completed cycle 1, 29 subjects started cycle 2, and 24 subjects completed cycle 2.~     The combined-modality therapy was well tolerated, but dose limiting toxicity (DLT) prevented~     Oxaliplatin and 5-FU escalation. No grade 4 hematologic toxicity was noted. Eleven grade 3~     and two grade 4 clinical toxicities were noted in eight subjects. After cycle 1, 29 subjects~     (81%) had no cancer in the esophageal mucosa. 13 subjects underwent an operation with intent~     to resect the esophagus and 5 subjects (38%) exhibited pathologic complete responses. There~     was no surgical mortality. Only 1 subject developed post-operative tracheoesphageal fistula.~     The results of these trials described above indicated that combination of oxaliplatin and~     radiation is safe and efficacious and dose not compromise surgical wound healing, repair and~     clinical outcome.~   "
251774|NCT00256295|"~     The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors~     including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and~     lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8~     oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was~     16% with no incidence of febrile neutropenia.~      Toxicity is a crucial consideration when designing regimens intended for palliation.~     Toxicities associated with cisplatin can make it difficult to use in patients with Head and~     Neck Cancer (HNC), many of whom are elderly and have comorbidities. In addition, many~     patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant~     therapy, or as part of their primary chemoradiation treatment. When these patients recur, it~     is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely~     to be better tolerated than cisplatin containing regimens, especially with regards to~     neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination~     chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy~     regimen using oxaliplatin and gemcitabine administered once every week is logical and worth~     exploring in patients with metastatic and recurrent head and neck cancer to improve the~     toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy~     regimen.~   "
251775|NCT00256282|"~     This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who~     have metastatic melanoma which has advanced beyond the point at which local therapies such as~     surgery or radiation therapy would be helpful. Without effective treatment, metastatic~     melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of~     chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally~     persisted. This research involves treatment with a combination of chemotherapy drugs known to~     be active against melanoma alone. The investigational purpose of this study is to determine~     if the combination of docetaxel, vinorelbine and sargramostim will produce a response~     (complete or partial) in metastasis melanoma. The researchers also wants to find out what~     side effects are associated with this combination of drugs.~   "
251776|NCT00256269|"~     The combination of cisplatin and irinotecan has significant anti-tumor activity in esophageal~     cancer. Oxaliplatin has been shown to have activity in combination with 5-Fluorouracil (5FU)~     and radiation in treatment of locally advanced esophageal cancer. Oxaliplatin also has better~     side effects profile than cisplatin and may be able to overcome tumors that have developed~     cisplatin resistance. The standard treatment of locally advanced esophageal cancer has been~     cisplatin, 5FU and radiation followed by possible esophagectomy. However, a large portion of~     these patients will relapse and the tumor may develop resistance to cisplatin and/or the~     cumulative toxicity from previous treatment forbids the use of cisplatin again. Weekly~     combination of oxaliplatin and irinotecan has been shown to be active and well tolerated in~     elderly population with refractory colorectal cancer. Therefore, we propose this phase II~     trial of a weekly oxaliplatin and irinotecan to test the effectiveness and the tolerability~     of this regimen in metastatic and/or recurrent esophageal cancer.~   "
251777|NCT00256256|"~     Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence~     world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing~     effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New~     animal studies indicate a protective effect of GLP-1 in the brain and the heart. The~     mechanism behind this is yet not known.~      The study hypothesis is that GLP-1 will stimulate glucose-uptake in the brain and heart~     independent of insulin and thereby exert its protective effects.~   "
251810|NCT00255814|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy~     in treating patients with liver metastases.~   "
251779|NCT00256230|"~     Melanoma remains a malignancy that is largely resistant to chemotherapy. Metastatic disease~     responds poorly to the treatments used today with only 2 out of 30 drugs tested, DTIC and~     nitrosoureas, showing response rates greater than 10%, and complete responses are rare.~     DTIC-based regimen has been recognized as a standard chemotherapy for advanced melanoma, and~     temozolomide demonstrated efficacy equal to that of DTIC and is an oral alternative agent~     that also crosses the blood brain barrier. Randomized phase III trials have shown no survival~     benefit of adding other agents (cisplatin, BCNU, and tamoxifen). Biochemotherapy is being~     developed extensively with moderate improvement in the responsive rate (approximately 50%)~     and is under evaluation in randomized trial to identify whether there is survival benefit to~     this strategy, compared with chemotherapy alone. Recently, a randomized phase III study~     comparing chemotherapy (cisplatin, dacarbazine, and tamoxifen) with biochemotherapy (the same~     chemotherapy regimen plus high-dose IL-2 and interferon alfa) have shown 44% response rate~     for biochemotherapy vs. 27% for chemotherapy. However, the tendency toward an increased~     response rate in patients who received biochemotherapy did not translate into an increase in~     overall survival, and there was, in fact, a trend for a survival advantage in patients~     receiving chemotherapy alone (median survival: 10.7 vs 15.8 months). New agents (or~     combinations) need to be developed for this refractory malignancy.~      The purpose of this study is to determine the response rate and evaluate the toxicity of~     disulfiram (DSF) in the treatment of Stage IV melanoma.~      The advantages of using DSF in this phase I/II trial are the following:~        -  DSF has been used as a drug for many years for the treatment of alcoholism. Its~          mechanism, pharmacokinetics, toxicity/tolerable dose are well known, and this drug is~          relatively non-toxic by itself at therapeutic dose. Doses of greater than 3000mg/m2 can~          cause reversible confusion.~        -  DSF can be taken orally; therefore, it is convenient to administer.~        -  DSF can penetrate the blood-brain barrier (unlike dacarbazine and many other~          chemotherapy agents); therefore, it might have an active effect on CNS metastasis.~      This study is designed to include women and minorities, but is not designed to measure~     differences of intervention effect.~   "
251780|NCT00256217|"~     Breast cancer is one of the most common cancers seriously afflicting women in the United~     States. Of the one million incident cases that are reported annually there are approximately~     193,000 new cases of breast cancer (Greenlee, 2001). Although significant advances have been~     made both in early detection and treatment of breast cancer, the impact of these on reduction~     in mortality has been modest (Peta, 2000). Furthermore, despite data implicating diet and~     other environmental risk factors, no lifestyle changes have yet been shown to significantly~     reduce the risk of breast cancer. Therefore, chemoprevention of breast cancer is a worthwhile~     approach to reduce the incidence of breast cancer.~      There is every reason to believe that a detailed understanding of the initiation, promotion~     and growth of breast cancer will ultimately provide a rational strategy upon which to base~     prevention strategies. While the pathways of breast cancer development are not yet fully~     understood, a role for estrogens in breast cancer etiology has been well established.~      While many pathways are involved in breast cancer etiology, including loss of tumor~     suppressor function by p53 or BRCA1 and gain of HER2 oncogene expression, their exact role in~     an individual patient's cancer development may vary.~      Therefore, it may be advantageous to focus on a chemoprevention strategy that may have a more~     uniform impact on breast cancer development, such as estrogen exposure. Estrogen and its~     metabolites, both in the circulation and locally synthesized in the breast, are important in~     the pathogenesis of breast cancer. High levels of circulating estrogen in postmenopausal~     women have been associated with an increased risk of breast cancer (Clemons, 2001).~     Furthermore, local estrogen synthesis, i.e. aromatase activity, in the breast may also be~     important in the development of breast cancer.~   "
251781|NCT00256204|"~     A 2 phase study to evaluate disease progression in Parkinson's disease patients taking~     rasagiline~   "
251782|NCT00256191|"~     Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is~     synthetically manufactured from naturally occurring taxanes extracted from yew starting~     material. The synthesis involves modification to the taxane side chain to overcome multidrug~     resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose~     escalation, sequential group, Phase 1 study evaluating the intravenous administration of TPI~     287 on an every 21 day cycle.~   "
251783|NCT00256178|"~     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily~     (QD), taken with simvastatin on cholesterol levels in subjects with primary dyslipidemia~   "
251784|NCT00256165|"~     The purpose of this study is to obtain data regarding the left ventricular mass (LVM)~     regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing~     LVM regression measured with magnetic resonance imaging (MRI) to LVM regression measured with~     echocardiography (2-dimensional [2D] mandatory; 3-dimensional [3D] in sites where the~     technology is available).~   "
251785|NCT00256152|"~     In patients with a standard indication for pacing and no previous history of AF, detection of~     Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.~      Overdrive atrial pacing with the AF Suppression algorithm will reduce the risk of symptomatic~     AF in patients with standard indication for pacing and no previous history of AF.~   "
251786|NCT00256139|"~     A multicentre, randomised, double blind, placebo controlled phase III study of subcutaneously~     administered Raptiva in the treatment of patients with moderate to severe psoriasis~   "
251787|NCT00256126|"~     The study aims at identifying the predictive markers after one month of Saizen therapy in~     Growth Hormone Deficiency (GHD) and Turner Syndrome children.~   "
251788|NCT00256113|"~     The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)~     in patients with depression.~      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to~     placebo in patients with depression.~      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy~     of saredutant on disability and quality of life in patients with depression, and to evaluate~     blood levels of saredutant.~   "
251789|NCT00256100|"~     The purpose of this project is to assess the safety and effectiveness of fondaparinux, a new~     drug to prevent blood clotting in the continuous dialysis machine used in intensive care~     patients who have kidney failure.~   "
251790|NCT00256087|"~     To assess the effect of addition of probiotic Lactobacilli to standard enteral feeding on~     infection rates and feeding efficacy in critically ill patients.~      The study hypothesis is that critically ill patients who receive the addition of probiotic~     lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections.~      The null hypothesis is that there will be no significant difference in the rate of hospital~     acquired infection in critically ill patients who receive enteral feeding with or without the~     addition of probiotic Lactobacilli.~   "
251791|NCT00256074|"~     The purpose of this study is to assess the impact of different feeding solutions on patients~     with breathing difficulty being supported by a breathing machine.~      The aim of the study is to determine if high fat-low carbohydrate feeding reduces the carbon~     dioxide production in patients with respiratory failure.~   "
251792|NCT00256061|"~     The study hypothesis is that in critically ill patients there is significant differences~     between electrolyte levels measured using blood gas analysers and by laboratory techniques,~     and between levels measured on arterial and venous blood samples.~   "
251837|NCT00255437|"~     The study will evaluate the safety and efficacy of a new intravenously administered iron drug~     to treat anemia in patients with chronic kidney disease who are not on dialysis.~   "
251838|NCT00255424|"~     The study will evaluate the safety and efficacy of a new intravenously administered iron drug~     to treat anemia in patients with chronic kidney disease who are not on dialysis.~   "
251794|NCT00256035|"~     In recent years, medical research into the cause and progression of heart disease due to~     narrowing and blockage of blood vessels to the heart muscle has improved the understanding of~     ischemic heart disease. It is now accepted that both the development and later progression~     with sudden blockage of blood vessels are associated with inflammation, although it remains~     unknown exactly what triggers this inflammatory process. It is possible that new blood tests~     which measure markers of inflammation in the bloodstream may be useful to help identify~     patients at risk of heart damage and assess response to treatment.~      The study plans to assess a new blood test for a known marker of inflammation (IL-4) in~     patients with heart disease.~      The hypothesis of this study is that, the cytokine, IL-4, measured by a new assay, is~     abnormally elevated in the blood of patients with coronary artery disease.~      Also hypothesized is that the degree of abnormality of blood IL-4, is related to important~     clinical events in such patients, including severity of disease, acute complications, and~     treatment.~   "
251795|NCT00256022|"~     The primary hypothesis for the study is that pre-operative prophylactic probiotic~     Lactobacilli tablets will reduce the severity and incidence of endotoxin rise in post~     cardiopulmonary bypass in cardiac surgery patients.~      Endotoxins are large heat stable lipopolysaccharides, which are found in the cell wall of~     gram negative bacteria. It has been assumed that the intestinal bacteria are the primary~     source of the plasma endotoxin in cardiac surgery patients.Lactobacilli have been reported as~     effective in counteracting gram negative bacteria in the gut.Thus Lactobacilli may be~     effective in reducing the endotoxin rise associated with cardiopulmonary bypass, which may~     potentially reduce the incidence of the syndrome of generalised inflammation and low systemic~     vascular resistance post cardiopulmonary bypass.~   "
251796|NCT00256009|"~     A randomize trial: expectation or evacuatio uteri for the treatment after late abortion~   "
251797|NCT00255996|"~     Evaluation of linezolid pk profile in burns patients~   "
251798|NCT00255983|"~     Identifying the role of antibiotics in the treatment of subjects with a microbiologically~     documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical~     trial. The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil~     versus placebo in the treatment of subjects with microbiologically documented AECB.~   "
251799|NCT00255970|"~     The purpose of this research study was to determine whether treatment with the bone grafting~     material Regenafil was as effective as the standard treatment using demineralized freeze~     dried bone allograft (DFDBA). Regenafil is demineralized freeze dried bone in a special gel~     form.~   "
251800|NCT00255957|"~     The use of HES has been found clinically to improve patients with stroke if administered~     within a window period by means of hemodilution to improve rehology. We propose to see the~     effects of long term administraion of HES in the amounts required for treating stroke~     patients and study the effects on the kinetics of HES, its effects on coagulation and~     hemorheology.~   "
251801|NCT00255944|"~     This study will evaluate the effectiveness of a tailored interactive online risk reduction~     program versus a standard online risk reduction program in reducing the risk of STD infection~     in young adults.~   "
251802|NCT00255931|"~     The purpose of this study is to determine the effect of biofeedback-relaxation combined with~     cognitive behavioral therapy on clinical, physical and psychological outcomes in patients~     with heart failure.~   "
251803|NCT00255918|"~     This study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in~     producing beneficial effects similar to that of nicotine in individuals with schizophrenia.~   "
251804|NCT00255905|"~     This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating~     insomnia symptoms that are secondary to depression. This study will also determine how long~     the benefits of CBT will last and how the recurrence of insomnia is associated with the onset~     of new depressive episodes.~   "
251805|NCT00255892|"~     This study is an exploratory qualitative investigation of the challenges, strengths, and~     needed areas of support associated with receiving an HIV diagnosis among youth living with~     HIV. Qualitative interviews will be conducted with health care providers who work with~     adolescents living with HIV and focus groups will be conducted with adolescents who are~     living with HIV (ages 16-24). One third of the focus groups will be conducted in Spanish.~     Findings from this study will be used to create an outline and development plan for a~     culturally-sensitive and developmentally appropriate intervention (or set of interventions)~     for youth recently diagnosed with HIV.~   "
251806|NCT00255879|"~     This study will assess the risk of experiencing tardive dyskinesia and other movement~     disturbances associated with three atypical antipsychotic drugs among middle-aged and elderly~     psychiatric patients.~   "
251807|NCT00255866|"~     This study will develop a treatment program to reduce mood and behavior problems in assisted~     living residents who have dementia.~   "
251808|NCT00255840|"~     The purpose of this study is to determine the effectiveness of several anti-HIV treatment~     strategies in resource-poor South African communities. The strategies being studied are using~     specially trained doctors or nurses to administer HIV care.~   "
251809|NCT00255827|"~     This 2-phase study will determine the safety of treating patients with pancreatic cancer with~     the genetically engineered HyperAcute-Pancreatic cancer vaccine. It will establish the proper~     vaccine dose and will examine side effects and potential benefits of the treatment. The~     vaccine contains killed pancreatic cancer cells containing a mouse gene that causes the~     production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the~     immune response to the foreign substance will stimulate the immune system to attack the~     patient's own cancer cells that have similar proteins without this sugar pattern, causing the~     tumor to remain stable or shrink.~      Patients 18 years of age or older with pancreatic cancer that has been surgically resected~     may be eligible for this study. Candidates will be screened with medical history and physical~     examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound~     scans may be obtained if needed.~      Participants will receive twelve vaccinations two weeks apart from each other. The vaccines~     will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase~     I of the study will treat successive groups of patients with increasing numbers of the~     vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase~     II will look for any beneficial effects of the vaccine given at the highest dose found to be~     safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine~     treatment. In addition, patient follow-up visits will be scheduled every 2 months for the~     remaining first year (6 months) after vaccination and then every 3 months for the next 2~     years for the following tests and procedures to evaluate treatment response and side effects:~      Medical history and physical examination Blood tests X-rays and various scans (nuclear~     medicine/CT/MRI) FACT-Hep Assessment questionnaire to measure the impact of treatment on the~     patient's general well-being. The questionnaire is administered before beginning treatment,~     monthly during treatment, and during follow-up visits after completing the treatment. It~     includes questions on the severity of pancreatic cancer symptoms and the ability to perform~     normal activities of daily life.~   "
251811|NCT00255801|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and bexarotene, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Bexarotene may also cause cutaneous T-cell lymphoma cells to look more~     like normal cells, and to grow and spread more slowly. Giving liposomal doxorubicin followed~     by bexarotene may be an effective treatment for cutaneous T-cell lymphoma.~      PURPOSE: This phase II trial is studying how well giving liposomal doxorubicin followed by~     bexarotene works in treating patients with cutaneous T-cell lymphoma.~   "
251812|NCT00255788|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor.~      PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to~     see how well they work in treating patients with recurrent or metastatic breast cancer.~   "
251813|NCT00255775|"~     RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from~     forming, growing, or coming back. The use of broccoli sprout extract may prevent lung cancer.~      PURPOSE: This clinical trial is studying how well broccoli sprout extract works in preventing~     lung cancer in smokers.~   "
251814|NCT00255762|"~     This phase II trial is studying how well giving carboplatin and paclitaxel together with~     bevacizumab works in treating patients with stage IV melanoma that cannot be removed by~     surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and paclitaxel~     together with bevacizumab may kill more tumor cells.~   "
251815|NCT00255749|"~     RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat~     anemia caused by cancer and chemotherapy.~      PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating~     patients with anemia who are undergoing chemotherapy for cancer.~   "
251816|NCT00255723|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses~     high-energy x-rays to kill cancer cells. Giving combination chemotherapy and radiation~     therapy with an autologous stem cell transplant, using peripheral stem cells or bone marrow~     from the patient, may allow more chemotherapy to be given so that more cancer cells are~     killed. Giving combination chemotherapy together with radiation therapy before an autologous~     stem cell transplant may be an effective treatment for Hodgkin's lymphoma.~      PURPOSE: This phase II trial is studying how well combination chemotherapy and radiation~     therapy work in treating patients who are undergoing an autologous stem cell transplant for~     relapsed or refractory Hodgkin's lymphoma.~   "
251817|NCT00255710|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy~     before a donor bone marrow or stem cell transplant helps stop the growth of cancer cells. It~     also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune system and help destroy any remaining cancer~     cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also~     make an immune response against the body's normal cells. Giving cyclophosphamide,~     mycophenolate mofetil, and tacrolimus after transplant may stop this from happening.~      PURPOSE: This phase I trial is studying cyclophosphamide and/or mycophenolate mofetil with or~     without tacrolimus to see which is the best regimen in treating patients who are undergoing a~     donor bone marrow or stem cell transplant for hematologic cancer.~   "
251818|NCT00255697|"~     RATIONALE: Studying quality-of-life in patients having cancer treatment and in their~     caregivers may help identify the intermediate- and long-term effects of treatment on patients~     with cancer and on their caregivers.~      PURPOSE: This clinical trial is studying quality of life of older patients who are undergoing~     treatment for cancer and of their family caregivers.~   "
251819|NCT00255684|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and~     radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the~     growth of cancer cells. It also stops the patient's immune system from rejecting the donor's~     stem cells. The donated stem cells may replace the patient's immune system and help destroy~     any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from~     a donor can also make an immune response against the body's normal cells. Giving cyclosporine~     and mycophenolate mofetil after transplant may stop this from happening.~      PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide~     together with total-body irradiation followed by cyclosporine and mycophenolate mofetil works~     in treating patients who are undergoing a donor umbilical cord blood transplant for~     hematologic cancer.~   "
251820|NCT00255671|"~     RATIONALE: Learning about the side effects of stereotactic radiosurgery in patients with~     brain tumors or other brain disorders may help doctors plan treatment and help patients live~     more comfortably.~      PURPOSE: This clinical trial is studying the acute side effects in patients who are~     undergoing stereotactic radiosurgery for brain tumors or other brain disorders.~   "
251821|NCT00255658|"~     This phase I trial is studying the side effects and best dose of temsirolimus when given~     together with sorafenib in treating patients with unresectable or metastatic solid tumors.~     Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood~     flow to the tumor. Giving sorafenib together with temsirolimus may kill more tumor cells.~   "
251822|NCT00255645|"~     This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24~     months, in patients with type 2 diabetes after participation in the phaseII/III studies~     GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined~     laboratory or clinical findings, will have a 12-week post-treatment follow-up visit,~     including laboratory evaluation and adverse event recording.~   "
251868|NCT00255021|"~     The present clinical study will assess the immunogenicity and reactogenicity of Sanofi~     Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary~     vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of~     life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.~   "
251823|NCT00255619|"~     Apart from haemodialysis, continuous ambulatory peritoneal dialysis (CAPD) is another~     effective therapy for end stage renal disease (ESRD). The Achilles heel of CAPD however is~     peritonitis, which is a major cause of morbidity and mortality in CAPD patients. Advances in~     connectology, such as the disconnect system, have resulted in reduced rate of peritonitis.~     The disconnect system which incorporated a Y-connection allow contamination occurring at the~     time of connection of the system to flush into the drainage bag thereby reducing the size of~     microorganism innoculum entering the peritoneal cavity. In recent years, the twin bag system~     where both the infusion and drainage bags are pre-attached to the Y tubing, has resulted in~     further reduction in peritonitis rate.~      Two different twin bags systems are being introduced into the MOH hospitals. They are Baxter~     UltraBag® and Fresenius Andy·Disc®.~      Even though both the systems are very similar, our own experience suggest that minor~     variation in the connectology could translate into marked differences in the peritonitis~     rate. In this multi centre, randomised controlled study, both the twin bag systems will be~     evaluated to establish their equivalence with respect to the incidence of peritonitis and~     technique failure.~   "
251824|NCT00255606|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It~     is not yet known which schedule of docetaxel and prednisone is more effective in treating~     prostate cancer.~      PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and~     prednisone to compare how well they work in treating patients with metastatic prostate~     cancer.~   "
251825|NCT00255593|"~     Current strategies for the medical management of transplant patients are largely focused on~     the prevention and treatment of T-lymphocyte mediated processes. However there is an~     increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell~     mediated rejection of transplants by there ability to act as antigen presenting cells and~     T-cell activators. Thus there is a significant medical need for effective therapies targeting~     B cells of transplant patients.One such potential therapy would be to use rituximab, a~     monoclonal antibody against B-cells in all renal transplant patients. In the present study~     the efficacy and safety of prophylactic rituximab is studied.~   "
251826|NCT00255580|"~     The purpose of this study is to determine if medicinal cannabis (marijuana) is safe and~     effective for treating pain in individuals with HIV-associated distal, sensory-predominant~     polyneuropathy (DSPN).~   "
251827|NCT00255567|"~     The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21~     days alone and SSG and PM as a combination course of 17 days in the treatment of patients~     with VL.~   "
251828|NCT00255554|"~     Subjects will receive six months of DBT, consisting of one 90-minute group and one 60-minute~     individual session per week as well as telephone availability of the individual therapist.~     Half the subjects will concurrently receive escitalopram while half will receive placebo, in~     a randomized double-blind design.~   "
251829|NCT00255541|"~     This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled~     (glibenclamide) study of tesaglitazar in patients with type 2 diabetes, not adequately~     controlled on diet and lifestyle advice alone during the run-in period. The study comprises a~     6 week placebo single blind run in period followed by a 52-week double blind treatment period~     and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to optimal~     effect or highest tolerable dose during the first 12 weeks.~   "
251830|NCT00255528|"~     This was a 4-week, multicenter, double-blind, placebo-controlled, randomized, parallel-group~     study to determine the antihypertensive dose range, efficacy, safety and tolerability of~     TOPROL-XL ® (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in~     hypertensive pediatric subjects. The study population included school age children (age 6 to~     < Tanner Stage 3) and adolescents (> Tanner Stage 3 to age 16) of both genders. No more than~     50% of the randomized subjects could be adolescents (> Tanner Stage 3 to 16 years old). Since~     response to some therapies in adult hypertension appears to be different in black and~     non-black populations, recruitment was aimed at a mixture of black and non-black children.~     The design included a 1-week screening period (for treatment naive subjects), a 1-week~     single-blind placebo run-in period, and a 4-week double-blind treatment period. Eligible~     subjects were randomized to the double-blind period with a once daily oral dose of metoprolol~     CR/XL to one of three target doses: 0.2, 1.0 and 2.0 mg/kg, or placebo. Dosing was weight~     adjusted. The dose range for this study was 12.5 to 200 mg daily. Subjects were closely~     monitored and evaluated at the end of Weeks 1, 2, 3 and 4 during the double-blind treatment~     period.~   "
251831|NCT00255515|"~     The purpose of this study is to compare efficacy of quetiapine fumarate combined with~     Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social~     outcome in patients with schizophrenia.~   "
251832|NCT00255502|"~     This was a 52-week, multicenter, open-label study to determine the safety, tolerability and~     pharmacokinetics of TOPROL-XL (metoprolol succinate) extended-release tablets (metoprolol~     CR/XL) in hypertensive pediatric subjects. The study population included school age children~     (age 6 to 12 years < Tanner Stage 3) and adolescents (> 12 years old or > Tanner Stage 3 to~     16 years old) of both genders. Because response to some therapies in adult hypertension~     appears to be different in black and non-black populations, the recruitment will have a~     mixture of black and non-black subjects. Pharmacokinetic measurements were performed on a~     subset of patients. Thirty subjects (15 subjects each in the 6 to 12 year age group and the~     13 to 16 year age group) had a series of blood samples drawn. All subjects had a trough~     plasma level taken 24 hours after the last dose of open-label metoprolol CR/XL (Visit 18)~     with the exception of those subjects who completed Protocol 307B (16 week open-label~     treatment).~   "
251833|NCT00255489|"~     The purpose of this study is to characterize the safety profile of ZD1839 in combination with~     Palliative thoracic Radiotherapy in patients with non-small cell lung cancer~   "
251834|NCT00255476|"~     The purpose of this study is to compare the objectie tumour response rate between the~     cisplatin/5FU and cisplatin/5FU plus ZD1839 combination~   "
251835|NCT00255463|"~     The purpose of this study is to compare the changes in a proliferation biomarker in subjects~     receiving Anastrozole or Anastrozole/ZD1839 combination.~   "
251836|NCT00255450|"~     This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared~     to placebo in patients with chronic kidney disease.~   "
251839|NCT00255411|"~     This study will explore how the mind and the brain work to cause movement symptoms or~     seizures in people who do not have a recognized neurological or medical disorder. The study~     includes a check for psychiatric disorders, symptoms and their severity; psychiatric and~     personality questionnaires; and neuropsychological testing.~      Normal, healthy volunteers, people who have movement symptoms not due to a brain or medical~     disorder and people who have seizures not due to epilepsy may be eligible for this study. All~     candidates must be 18 years of age or older.~      All participants have a medical history, physical examination and psychological evaluation,~     including completion of questionnaires. People with movement symptoms or seizures have a~     symptoms evaluation.~      Some participants also undergo neuropsychological testing, including questionnaires,~     pen-and-paper or computerized tests, and motor tasks.~   "
251840|NCT00255398|"~     Kidney Disease Biomarkers~      Summary: This study will identify biomarkers (proteins and other molecules in the blood or~     urine) that may help scientists predict what kidney disease a patient has and whether a given~     patient would respond to particular therapies. The study will look for biomarkers in the~     blood and urine of patients with various kidney diseases and study of the effects of~     angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers~     (ARB) on biomarkers. Blood and urine from healthy volunteers will be studied for comparison.~      Healthy people and the following patients may be eligible for this study: adults with~     diabetic nephropathy 18 years of age and older; children with newly diagnosed clinical~     idiopathic nephrotic syndrome between 2 and 18 year of age; children and adults with~     glomerular disease (minimal change disease, focal segmental glomerulosclerosis, or collapsing~     glomerulopathy).~      Participants undergo tests and procedures as follows:~      Glomerular Disease: Adults with glomerular disease provide about four to six blood and urine~     samples over the course of 6 to 12 months. The samples are collected at the time of regularly~     scheduled visits for the NIH treatment protocol in which they are participating. Children~     provide only blood samples.~      Chronic Kidney Disease: Patients with chronic kidney disease provide a blood and urine sample~     every 6 months for 3 years or more.~      Angiotensin Antagonism: Patients with chronic kidney disease who are taking ACE inhibitors or~     ARBs stop their medicines for 4 weeks, while those who are not taking ACE inhibitors or ARBs~     begin one of the medicines. In general, patients just starting on the medications continue~     them after the study is completed, since they are beneficial for chronic kidney disease.~        -  Medication withdrawal group: Patients come to NIH for 2 successive days at the beginning~          of the study for blood and urine tests (including one 24-hour urine collection) and to~          receive iothalamate (a chemical used to measure kidney function). Iothalamate is~          delivered over 24 hours through a needle placed in the abdomen (or elsewhere) via a pump~          similar to pumps that some diabetics use to deliver insulin. Patients then stop taking~          their ACE inhibitor or ARB medication. They monitor their blood pressure every day and~          return to NIH after 1, 2 and 4 weeks for blood tests. During week 4, the iothalamate~          infusion is repeated, and blood and urine samples are collected as at the beginning of~          the study. Patients then resume taking their ACE inhibitor or ARB once a day with the~          dose being increased at 2-week intervals. They come to NIH weekly after 1 week and then~          every other week for blood tests. Four weeks after reaching the highest FDA-recommended~          dose of medication tolerated, the iothalamate infusion and blood and urine collections~          are repeated.~        -  Medication induction group: At the beginning of the study, patients have the iothalamate~          infusion and blood and urine collections described above and then begin to take either~          an ACE inhibitor or ARB. The dose is increased after 2 weeks. Patients monitor their~          blood pressure every day. After being on the highest dose for 4 weeks, patients repeat~          the iothalamate infusion and blood and urine collections. The study is then complete and~          they are provided a 2-month supply of medicine to take home.~      Information is gathered on symptoms, treatments, and results of past laboratory tests of all~     patients. Healthy volunteers provide blood and urine sample collections every month or every~     other month for up to four collections to be used for biomarker studies and the screen for~     common chronic diseases.~   "
251841|NCT00255385|"~     The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or~     with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and~     improvement in growth and development.~   "
251842|NCT00255372|"~     The purpose of this study is to determine whether Forlax® is more effective than placebo in~     relieving chronic constipation in children who may also suffer from soiling or faecal~     incontinence.~   "
251843|NCT00255359|"~     The study will be a randomized, double blind, placebo controlled, dose rising study in~     Interferon alpha (IFN-alpha) non-responder HCV infected patients or HCV patients who have~     relapsed following IFN-alpha therapy. Eligible subjects must have compensated liver disease~     and serum HCV RNA concentrations above 100,000 IU/mL at screening. The study will include~     both a single dose period for the evaluation of acute toxicity and single dose~     pharmacokinetics and a consecutive multi-dose period for the determination of longer-term~     safety, multiple-dose pharmacokinetics and antiviral activity. The objectives of this study~     are to evaluate the safety, tolerability, and antiviral activity of escalating single and~     multiple doses of XTL 2125 in patients with chronic hepatitis C virus infection and to assess~     the single- and multiple-dose pharmacokinetics of XTL 2125~   "
251844|NCT00255346|"~     The goal of this clinical research study is to learn if dasatinib can help to control~     myeloproliferative disorders. The safety and tolerability of dasatinib will also be studied.~   "
251845|NCT00255333|"~     The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer~     drug, are being studied in patients with solid tumors.~   "
251846|NCT00255320|"~     We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP~     induced headache may be associated with dilatation of intra- and extracerebral blood vessels.~     To test this hypothesis, we performed a double blind placebo controlled crossover study in~     normal human volunteers and studied the effect on headache and cerebral as well as~     hemodynamic parameters.~   "
251847|NCT00255307|"~     This is a randomized double-blind three-arm trial to evaluate two dosages of CVT-E002 against~     placebo in pediatric upper respiratory tract infections (URTI). It is hypothesized that~     CVT-E002 use at standard doses reduces the duration of URTI in children aged 3-12 years.~   "
251848|NCT00255294|"~     This study will evaluate the contraceptive effectiveness of cellulose sulfate vaginal gel in~     preventing pregnancy when used for 6 months.~   "
251849|NCT00255281|"~     The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion~     from AF~   "
251850|NCT00255268|"~     To evaluate the efficacy, safety and survival of two treatment regimens: Continuous~     Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with~     prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated.~     QoL evaluation is also included.~   "
251851|NCT00255255|"~     This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation~     b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS~     and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.~   "
251852|NCT00255242|"~     Individuals with cystic fibrosis (CF) have persistent infection in the airways, which the~     body attempts to fight by recruiting immune cells (neutrophils) to the lung. The immune~     system and neutrophils are unable to completely kill the bacteria, and the response to the~     infection leads to inflammation (swelling) of the airways and lung damage. Nitric oxide (NO)~     has anti-bacterial and anti-inflammatory properties in the lung. NO production is decreased~     in CF patients, and may contribute to the persistent infection and inflammation. Increasing~     the production of NO in the airways of CF patients may help decrease this inflammation and~     infection.~      Rho GTPases are molecules in the cells that line the airways that decrease the protein that~     makes nitric oxide (NOS). Rho proteins also increase inflammation in these cells. Rho~     proteins are increased in CF cells, and may partially explain the low NO and high~     inflammation seen in CF. Blocking the Rho protein in CF cells increases NOS, which can then~     produce more NO. The Rho protein can be inhibited with a drug, simvastatin (Zocor®).~     Simvastatin is used by millions of people to lower their cholesterol, is very safe, has few~     side-effects and is approved for use in children greater than 10 years of age. We propose~     that treating CF patients with simvastatin will increase NO produced (exhaled NO), and may~     decrease airway inflammation.~      If simvastatin has these expected effects in CF, it would be another drug that has potential~     to become a new therapy to fight the debilitating lung damage of the disease.~   "
251853|NCT00255229|"~     Irinotecan (7-ethyl-10- {4(-1-piperidino)-1-piperidino} carbonyloxy camptothecin) is a~     semisynthetic camptothecin derivative introduced in the 1980's. Irinotecan is a prodrug~     metabolized by carboxylesterases to an active metabolite 7-ethyl-10-hydroxy-camptothecin~     (SN38). SN38 exerts its cytotoxic effect by forming stable complexes with topoisomerase I and~     DNA. These complexes collide with replication forks and cause breaks in DNA. Studies~     substantiated irinotecan's activity in 5FU resistant colorectal cancer and led to its~     approval for treatment of 5FU resistant colorectal cancer in the United States, Canada and~     Europe.Colorectal cancer studies demonstrated that single agent irinotecan's dose limiting~     toxicity was diarrhea occurring 5 to 6 days after its administration. High dose loperamide at~     first occurrence of diarrhea has decreased the incidence of diarrhea but the incidence of~     grade 3/4 diarrhea remains high at 28 to 40%.~   "
251885|NCT00254787|"~     The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release)~     quetiapine in a rapid escalation scheme with to the current approved label titration.~   "
251854|NCT00255216|"~     Policosanol, a compound derived from sugar cane wax and available in health food stores~     across the United States, is a popular non-prescription product for treating~     hypercholesterolemia. Virtually all of the published medical literature on policosanol has~     been authored by research groups in Cuba.~      This study will assess the short-term safety and efficacy of policosanol in healthy adults~     who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary~     care clinics consisting primarily of Caucasian and African-American patients. The primary~     outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include~     changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein~     sub-particles. This will be the first known randomized clinical trial of policosanol in North~     America.~      The data derived from this pilot study regarding the lipid lowering effects of policosanol~     will be used to support applications for further funding through institutions outside the~     Carolinas Healthcare System including the National Institute of Health (NIH).~      Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a~     small pilot study.~   "
251855|NCT00255190|"~     The purpose of this study is to determine the long-term safety profile of daily treatment~     with dexlansoprazole MR in subjects with gastroesophageal reflux disease.~   "
251856|NCT00255177|"~     Hepatitis C virus (HCV) infects approximately 170 million people worldwide. The current~     standard- of- care therapy of chronic HCV infection is a regimen of subcutaneously~     administered (pegylated)-interferon-α and ribavirin for 24 weeks (for genotypes 2 and 3) to~     48 weeks (for genotype 1). The sustained viral response rates (SVR) in patients infected with~     genotypes 2 and 3 are ~80% but remain <50% in patients infected with genotype 1. The~     treatment is quite toxic with approximately 30% of patients experiencing adverse events (i.e.~     depression, fever, anemia, fatigue) requiring dose reduction or discontinuation of therapy.~     This regimen is contraindicated in women who are pregnant and in patients with decompensated~     liver disease. The absence of acceptable therapies for many patients with HCV infections~     makes new therapies desirable for this disease.~   "
251857|NCT00255164|"~     The purpose of this study is to assess the ability of once-daily (QD) treatment with~     Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of~     erosive esophagitis (EE).~   "
251858|NCT00255151|"~     The purpose of this study is to assess the ability of once-daily (QD) treatment with~     Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of~     erosive esophagitis (EE).~   "
251859|NCT00255138|"~     The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in~     enhancing attention and concentration among childhood survivors of cancer.~   "
251860|NCT00255125|"~     This is a randomized study evaluating the effectiveness and direct effect a commercial soy~     supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it~     either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned~     surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be~     evaluated to determine the effects of the soy supplement on the prostate tissue.~   "
251861|NCT00255112|"~     The purpose of this study is to determine whether a specific family based cognitive~     behavioral treatment program is effective in the treatment of children with separation~     anxiety disorder.~   "
251862|NCT00255099|"~     The purpose of this study is research with the goal of evaluating the effect of TMC125 (a~     non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus.~     The study will also investigate whether this new medication is well tolerated, and to further~     confirm that the medication is safe to be used~   "
251863|NCT00255086|"~     The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a~     neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain~     NAA and magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In~     secondary analyses, we will determine if measures of clinical stabilization produced by~     memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS~     measures of brain NAA and MRI volumetric measures of hippocampal volume.~   "
251864|NCT00255073|"~     Reduction of spasticity has been a major focus of the treatment of childhood cerebral palsy,~     resulting in numerous treatment strategies that target various parts of the motor system.~     However, in many children weakness may be a greater contributor to disability than~     spasticity. Recent results suggest a correlation between spasticity and weakness, but it is~     not known if reduction of spasticity can improve strength.~      We suggest a simplified model in which spinal mechanisms (including reflex contributions to~     spasticity) and supraspinal mechanisms (including voluntary contributions to strength)~     combine to activate muscle. The model implies that the supraspinal contribution cannot~     increase unless the spinal contribution decreases. We therefore hypothesize that reduction of~     spasticity improves the ability to increase voluntary strength.~      We propose a double-masked placebo-controlled clinical trial combining treatment using the~     oral anti-spasticity medication baclofen with a 6-week program of strength training. We will~     enroll 20 ambulatory children with spastic diplegic cerebral palsy. Prior to and following~     the intervention, we will obtain quantitative measures of spasticity, strength, and gait. We~     predict that the children taking baclofen will have a greater increase in strength than the~     children taking placebo. We predict that the increase in strength will be reflected in~     improved performance on gait analysis, and it will correlate with a reduction in quantitative~     measures of spasticity and spinal reflex excitability.~      If the hypothesis is correct, it will provide important new information on the relationship~     between spasticity and strength in children with cerebral palsy. It will provide the first~     measurements of the effect of baclofen on voluntary muscle activation in children. It will~     support the short-term use of combined anti-spasticity medication and strengthening as a new~     clinical treatment for ankle weakness in children with spastic diplegia. A successful result~     will have immediate and significant implications for treatment of children with cerebral~     palsy.~   "
251865|NCT00255060|"~     To screen women who are high risk for breast cancer with breast MRI, mammogram and random~     periareolar fine needle aspiration.~   "
251866|NCT00255047|"~     The overall aim of the study is to corroborate that a schedule consisting of 3 doses of~     Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of~     Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3~     doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus~     vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.~   "
251867|NCT00255034|"~     This is an Australian, open-label, multicenter, randomized, double-blind clinical trial~     designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and~     ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C~     (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at~     least F1A2). The primary endpoint will be a sustained virological response defined by~     undetectable HCV RNA in serum at 24 weeks after completion of therapy.~   "
251886|NCT00254774|"~     The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate~     during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid~     Cycling.~   "
251869|NCT00255008|"~     This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy~     with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1~     chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian~     patients with genotype 1 chronic hepatitis C. This study is also designed to provide a~     randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in~     Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic~     response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at~     24 weeks after therapy completion.~   "
251870|NCT00254995|"~     To further characterize the safety profile of Menactra vaccine and to identify any signals of~     potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.~   "
251871|NCT00254982|"~     This is an open-label, multicenter, parallel-group comparison study of the efficacy, safety,~     and tolerability of infliximab therapy in adult patients suffering from chronic plaque~     psoriasis (psoriasis vulgaris). Patients will be assigned to GROUP I (high need) or GROUP~     II (low-need) by the investigator according to their previous psoriasis treatment.~   "
251872|NCT00254969|"~     The present clinical study will assess the immunogenicity and reactogenicity of Aventis~     Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary~     vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of~     life in order to meet the requirements for application for the use of the product in the~     Expanded Program on Immunization (EPI) in South Africa.~   "
251873|NCT00254956|"~     The primary objective is to demonstrate the non-inferiority of ciclesonide compared to~     beclomethasone-HFA in the occurrence of Class 1 lens event for nuclear (NO), cortical (C), or~     posterior subcapsular (P) lens opacification within 12 months. Secondary objectives are to~     compare ciclesonide and beclomethasone with respect to class II and class III best corrected~     visual acuity and intraocular pressure from baseline to 12 months.~   "
251874|NCT00254930|"~     The purpose of this study is to assess whether risperidone (an antipsychotic medication) is~     safe and effective in treating behaviour disorder in learning disabled children, which does~     not improve with psychological therapy.~   "
251875|NCT00254917|"~     The present clinical study will assess the immunogenicity and reactogenicity of the~     subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine~     (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age~     schedule followed by a booster vaccination during the second year of life with the aim to~     cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus,~     pertussis, poliomyelitis and Hib vaccines.~      WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks~     of age) will be also assessed in infants born to HBsAg seronegative mothers.~      To assess the safety of Pentaxim.~   "
251876|NCT00254904|"~     To assess the efficacy and safety of PF-3512676 administered in combination with~     gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced~     or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety~     of gemcitabine/cisplatin alone.~   "
251877|NCT00254891|"~     To assess the efficacy and safety of PF-3512676 administered in combination with~     paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced~     or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety~     of paclitaxel~   "
251878|NCT00254878|"~     Currently two different brands of modified-release formulations are providing 50% immediate~     release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and~     dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the~     other one by Medice (Germany).~      The objective of the study is to test the hypothesis that the Novartis product is superior to~     placebo and is clinically not inferior to the formulation manufactured by Medice.~   "
251879|NCT00254865|"~     The objective of this study is to compare the levels of the hormones norelgestromin,~     norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers~     administered ORTHO EVRAÂ® (a transdermal contraceptive patch) and CILESTÂ® (an oral~     contraceptive). The open-label treatment phase of the study consists of two 28-day cycles of~     one treatment, a washout period of 28 days, and crossover to two 28-day cycles of the other~     treatment.~   "
251880|NCT00254852|"~     The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to~     autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one~     level is defined as two adjacent vertebrae), L2 and below.~      The primary endpoint will be the assessment of fusion by evaluation of x-rays taken following~     surgery at each visit. The x-ray evaluation will be conducted by a radiologist who is blinded~     to the type of treatment each patient has received.~      Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative~     (post-op). Questionnaires and x-rays will be completed at each visit and a computed~     tomography (CT) scan will be taken at the 12 month visit(and used to aid in assessment of~     bridging bone, where appropriate).~   "
251881|NCT00254839|"~     Malodor production is bacterial in origin. The bacterial activity of anaerobic bacteria~     results in the breakdown of proteins and the production of foul smelling compounds. The aim~     of the study is to test the hypothesis that bacterial growth on dental implants contributes~     to malodor production and to see whether this contribution is associated with various~     properties of the dental implant such as: maker, type, depth ext.~   "
251882|NCT00254826|"~     The purpose of this study is to determine whether immune globulin can limit the amount of~     yellow fever vaccine virus present in the blood after vaccination without compromising the~     immunity associated with the yellow fever vaccine. The study will enroll 80 participants in~     two groups of 40 each. The first group will receive the yellow fever vaccine with salt-water~     placebo. The second group will receive yellow fever vaccine with immune globulin. The amount~     of vaccine virus and immune response in both groups will be compared. Yellow fever vaccine~     has been used to protect humans against Yellow Fever Vaccine disease since the 1930s.~   "
251883|NCT00254813|"~     The purpose of this study is to evaluate the safety and tolerability of a more rapid dose~     titration in acute schizophrenic patients compared to the conventional titration.~   "
251884|NCT00254800|"~     The purpose of this study is the examine the effect of taking exenatide on the blood levels~     (pharmacokinetics) of orally-administered contraceptives.~   "
251888|NCT00254748|"~     In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective~     in the treatment of psychosis. In patients with borderline personality disorder (BPD), as far~     as the investigators know, no well designed controlled studies have been performed on the~     effect of one of the newer atypical antipsychotics on psychotic symptoms.~      It is of interest to investigate the benefit of quetiapine treatment in these types of~     patients. Quetiapine possibly gives less side-effects because of the expected lack of~     elevated prolactin levels, which is of importance in this patient group, overrepresented by~     young females. In this double blind, randomized, placebo controlled, 8 week, parallel group,~     multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be~     compared with the placebo.~   "
251889|NCT00254735|"~     The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to~     baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.~   "
251890|NCT00254722|"~     The purpose of this study is to determine if bone marrow progenitor cell (BMPC) autologous~     transplantation in children after isolated traumatic brain injury is safe and will improve~     functional outcome.~   "
251891|NCT00254709|"~     The purpose of this study is to test two different sirolimus-based immunosuppressive regimens~     for elderly kidney transplant recipients.~   "
251892|NCT00254696|"~     -  To determine the value of using piperacillin/tazobactam in reducing the cases of ESBL~          producing E. coli or K. pneumoniae colonization and infection.~        -  To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre~          and post intervention in the selected medical centers.~   "
251893|NCT00254683|"~     Preoperative chemoradiation therapy is the preferred initial treatment option for distal~     rectal cancers. However, assessing tumor response to preoperative chemoradiation therapy~     remains a challenge to the colorectal surgeon, especially when determining if there is a~     complete response, observed in more than 10% of cases. The purpose of this study is to~     evaluate the use of the PET/CT in assessing distal rectal tumor response to preoperative~     chemoradiation therapy.~   "
251894|NCT00254670|"~     The purpose of this study is to examine drinking behavior and decision-making while taking~     Naltrexone and placebo. This is a double-blind, randomized, placebo-controlled crossover~     study. There are two cycles: one cycle on Naltrexone and one cycle on placebo.~   "
251895|NCT00254657|"~     The purpose of this study is to assess the safety and effectiveness of levetiracetam in~     reducing the pain of fibromyalgia when compared to placebo. Levetiracetam, an anti-seizure~     drug, is currently FDA-approved and marketed for use in patients with seizures. Levetiracetam~     may relieve pain by reducing abnormal activity in the nervous system. A placebo is an~     inactive substance.~   "
251896|NCT00254644|"~     Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze~     cortical thickness and phonological treatment in right handed adults with developmental~     dyslexia. They are compared to control adults paired with age and laterality. To study~     phonological treatment, the researchers used functional magnetic resonance imaging (fMRI)~     with a rime judgement task and silent word generation.~   "
251897|NCT00254631|"~     We would like to check whether pre-operative administration of an oral controlled-release~     opioid formulation (Oxycodone hydrochloride (OxyContin)) could result in a clear effect of~     preemptive analgesia.~   "
251898|NCT00254618|"~     The purpose of this randomized, open-label, parallel-group study is to determine how the body~     absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60~     mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days~     to children and adolescents with active ulcerative colitis.~   "
251899|NCT00254605|"~     The purpose of this study is to determine whether the structure and function of the human~     retina can be studied with high resolution in patients with inherited retinal degenerations~     using the Adaptive Optics Scanning Laser Ophthalmoscope (AOSLO).~   "
251900|NCT00254592|"~     Study Aims~        1. To measure the clinic response rates in patients with breast cancer more than 2 cm~          and/or lymph node positive breast cancer treated with 2-4 cycles of biweekly~          doxorubicin, cyclophosphamide with Granulocyte-macrophage colony-stimulating factor~          (GM-CSF) (days 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks,~          followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in~          addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will~          receive Bevacizumab (6-8 doses) q 2 weeks).~        2. To measure the microscopic pathological response rate of this regimen.~        3. To measure toxicity and the delivered dose intensity of this regimen.~        4. To assess the association between microscopic pathologic complete response and clinical~          complete response at the primary tumor site in these patients.~        5. To determine whether the GM-CSF increases the post treatment dendritic cells (S100+)~          percentage in the tumor draining lymph node as compared to pretreatment S100+ cells.~        6. To determine whether the patients with a higher percent S100+ have a better clinical,~          pathological response, Disease Free Survival (DFS), and overall Survival (OS).~        7. To determine whether flow cytometry of dendritic cells performed post-treatment in blood~          sample shows an increase in dendritic cell population compared to pretreatment levels.~   "
251901|NCT00254579|"~     CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which~     is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate~     patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct~     effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients~     with metastatic melanoma in Phase 1 and Phase 2 clinical studies.~   "
251902|NCT00254566|"~     This trial is a research drug study to compare the effects of two antibiotics for the~     treatment of acute exacerbation of chronic bronchitis~   "
251903|NCT00254553|"~     Hypogonadal males, particularly those whose condition manifested later in life, may~     experience common symptoms associated with their hypogonadism. Questionnaires developed to~     assess these symptoms need to be tested. The primary purpose of this study is to test or~     validate the Patient-Reported Symptom Measure, Androgen Deficiency Quality of Life~     Questionnaire and the Patient Global Impression Scale.~   "
251904|NCT00254540|"~     To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally~     once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with~     metastatic Renal Cell Cancer (RCC).~   "
251906|NCT00254514|"~     This trial is conducted in Africa, Europe and Middle East. This trial investigates the~     efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to~     placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the~     first part, the patients will be evaluated with regard to efficacy (fracture healing) and~     safety at short time intervals until week 24 post-surgery. In the second part, long-term~     safety and fracture healing up to 12 months post-surgery will be evaluated.~   "
251907|NCT00254501|"~     This study will look at the impact of health insurance benefits on self management of~     diabetes for people with this condition. Studies have shown that when people with diabetes~     manage their disease better, they stay healthier. Our goal in this study is to help those~     with diabetes better manage their disease (self-care). We will compare two types of health~     insurance benefits in this study. We want to see if one set of benefits improves self-care~     more than the other one.~   "
251908|NCT00254488|"~     This study will compare the benefits and side effects of lithium and divalproex in the~     treatment of older adults with bipolar mania.~   "
251909|NCT00254475|"~     The purpose of this study is to provide data on the dose response of simvastatin in lowering~     LDL-C when it is co-administered with valsartan in patients with both essential hypertension~     and hypercholesterolemia. The primary objective of the study will be to show that the~     combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the~     combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.~   "
251910|NCT00254462|"~     This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of~     attention deficit hyperactivity disorder (ADHD) in young children.~   "
251911|NCT00254449|"~     The purpose of this study is to evaluate epidermal nerve fiber (ENF) regeneration and~     normalization of peripheral sensory nerve function over time in normal healthy volunteers~     following a 60 minute application of Capsaicin Dermal Patch (NGX 4010; capsaicin 640 mcg/cm2)~     as compared to comparable untreated skin areas (control).The objectives of this study are: 1)~     To assess the difference between patch-treated and comparable untreated skin areas (control)~     in ENFD as quantified by PGP 9.5 immunohistochemical staining of skin biopsy samples obtained~     at 1, 12 and 24 weeks following a 60 minute application; 2) To assess the difference between~     patch-treated and comparable untreated skin areas (control) for thermal detection thresholds~     as assessed by QST at 1, 12 and 24 weeks following a 60 minute application; and, 3) To assess~     the difference between patch-treated and comparable untreated skin areas (control) in~     mechanical (sharp pain) sensation and tactile threshold at 1, 12 and 24 weeks following a 60~     minute application.~   "
251912|NCT00254436|"~     To demonstrate the effectiveness of epoetin alfa on reduction in red blood cell transfusions~     in gastric and rectal cancer patients undergoing preoperative chemoradiation therapy followed~     by surgery.~   "
251913|NCT00254423|"~     The goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to~     control CML in chronic phase. The safety of this drug will also be studied.~   "
251914|NCT00254410|"~     The goal of this clinical research study is to learn if using a combination of fludarabine,~     cyclophosphamide, and mitoxantrone plus rituximab, with the growth factor pegylated~     filgrastim, will improve the response to treatment, and increase the time this response~     lasts, for patients with previously untreated CLL. The safety of this combination will also~     be studied.~   "
251915|NCT00254397|"~     The goal of this clinical research study is to learn if the drug leuprolide will increase the~     level of immune cells in your body. Researchers will also want to know if this drug given~     together with melanoma vaccines (gp100 and MAGE-3) can improve the ability of tumor fighting~     immune cells (T cells) to fight melanoma cells.~      Primary Objective:~      1. To compare the tumor-specific immune responses to melanoma-specific peptide vaccines,~     gp100 and MAGE-3 in the presence or absence of a luteinizing hormone-releasing hormone (LHRH)~     agonist-Leuprolide, in patients with stage IIb and III melanoma, uveal melanoma or stage IV~     melanoma that the metastatic lesion(s) has been surgically removed.~      Secondary Objectives:~        1. To evaluate the kinetics of enhanced thymic activity measured by TREC analysis and flow~          cytometric analysis following sex hormone ablation by Leuprolide in melanoma patients.~        2. To assess whether there are significant differences in overall quality of life (QOL)~          between patients receiving Leuprolide to those not receiving leuprolide.~   "
251916|NCT00254384|"~     The goal of this clinical research study is to learn if chemotherapy (cisplatin, docetaxel)~     is safe to give to patients whose lung cancer will be surgically removed, and to learn if~     maintenance therapy with the biologic agent erlotinib, given after surgery, is safe. Another~     goal of this study is to look at changes that occur in epidermal growth factor receptor~     (EGFR) and how these changes are reflected in different cells in the body. The effect of this~     treatment on the participant's quality of life and survival, as well as its effect on~     different cells in the body, will also be studied.~   "
251917|NCT00254371|"~     Sarcopenia is a major health problem among the rapidly expanding elderly population in our~     society. Disabilities directly related to muscle weakness, and indirectly related to changes~     in body composition and metabolic dysfunctions, are causing a staggering toll in disability~     and health care costs.~      Osteopenia occurs almost simultaneously with sarcopenia in the elderly population and muscle~     weakness increases the risk for falls and therefore, fractures. Although these issues have~     been separate addressed in several studies, an integrated investigational approach to better~     understand the pathogenesis of sarcopenia and other age-related metabolic abnormalities and~     to investigate the potential role of androgens have not been undertaken in a comprehensive~     manner.~      The program contains four independent research programs, each representing different research~     disciplines, and four separate cores supporting the four projects.~      The main focus of the project is to determine the effect of the replacement of testosterone~     in elderly men and DHEA in elderly men and women and to compare these effects with placebo~     treatment over a two-year period.~      Project 1, Effect of Androgen Replacement on Muscle Metabolism will specifically determine~     whether these interventions have a differential effect on size and quality of muscle in terms~     of strength and metabolic functions. Project 2, Effect of Androgen Replacement on Bone~     Metabolism, will determine the effects of this intervention on bone mineral density and~     markers of bone turnover.~      Project 3, The Effect of Androgen Replacement on Carbohydrate Metabolism, will determine~     whether the age-associated decrease in circulating androgens contributes to the alterations~     in carbohydrate metabolism that are commonly observed in the elderly and on insulin action,~     insulin secretion, and glucose effectiveness.~      Project 4, Effect of Androgen Replacement on Fat Metabolism will determine whether changes~     in fat distribution that occur with aging could result from differences in regional fatty~     acid uptake and systemic fatty acid kinetics, and whether these determinants of fat~     distribution are altered by the interventions.~      The data emerging from these studies will be integrated to determine the intervention of~     sarcopenia with other metabolic changes and hopefully will contribute to a better~     understanding of muscle, bone, carbohydrate and fat metabolism.~      This study will hopefully form the scientific basis for future trials of androgen replacement~     in the elderly.~   "
252308|NCT00249197|"~     The purpose of this study is to compare the safety and effectiveness of levofloxacin (an~     antibiotic) with ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the~     treatment of complicated skin infections.~   "
251918|NCT00254358|"~     Tobacco Smoking is the most prevalent addiction in society today causing directly major~     health hazards and sharing morbidity with other psychiatric disorders. Nicotine binds to~     acetylcholine receptors and thus elevates DA release and inhibits DA transport. There are few~     studies using advanced brain imaging techniques to investigate how nicotine releases dopamine~     in humans. These studies utilized dopamine displacement paradigms with [11C] Raclopride~     binding to D2 receptor in Positron Emission Tomography (PET). There is evidence that smokers~     (particularly those who enjoyed smoking) showed decreased [11C] Raclopride binding in the~     caudate/nucleus accumbens and putamen after smoking cigarettes. These results also indicated~     that the effects of nicotine on dopaminergic neurotransmission are mediated by pleasure and~     craving. We propose to investigate the effects of smoking a cigarette ad lib on dopamine~     release by using dopamine competition paradigm with [I123] IBZM in SPECT. Secondly, we will~     test the hypothesis that dopamine deficiency is a major vulnerability factor for smoking.~     This may provide further evidence that dopamine deficiency in some smokers pre-disposes them~     to enjoy and desire smoking cigarettes more than others.~   "
251919|NCT00254345|"~     Auto polymerizing poly methyl methacrylate (PMMA), and light initiated resin modified PMMAs,~     are commonly used for fabricating provisional restorations (PRs) during prosthetic treatment~     1. Biofilm accumulated on these PRs may cause caries and inflammation of the surrounding~     tissue, tempering the outcome of the final restoration 2. Plaque adherence to temporary~     restorations was significantly increased compared with the untreated reference teeth 3.~     Biologic and physical properties of the various materials used as PRs were studied~     extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less~     characterized.~      One improvement in provisional restorative materials is the use of liquid polish. It is~     claimed that these materials gives a high luster finish to provisional bis-acryl restorations~     and processed acrylic appliances, reduces or eliminates costly and time consuming polishing~     steps and can be used on all types of direct and indirect restorations and appliances.The~     effect of liquid polish coating or resin bonding coating on biofilm formation on PRs was not~     reported.~   "
251920|NCT00254332|"~     This is a blood and tissue study to determine the effect of the drug called denileukin~     diftitox on the immune system cells that may be involved in patient response to their~     cutaneous t-cell lymphoma.~      Patients who are undergoing standard of care therapy with denileukin diftitox will be invited~     to participate. Blood and tissue samples will be obtained at baseline, day 5 and day 19 in up~     to the first 4 cycles of denileukin diftitox.~   "
251921|NCT00254319|"~     Avastin is a novel antiangiogenic agent that has recently been shown to improve response~     rates and survival of patients with advanced nonsquamous non-small cell lung cancer when~     added to front-line carboplatin/paclitaxel chemotherapy, and is now being routinely~     incorporated into the treatment of these patients. Alimta is a recently approved~     chemotherapeutic that has shown activity against non-small cell lung cancer when given alone~     and in combination with carboplatin, has a favorable toxicity profile andrequires only a~     brief (10 minute) infusion time. Therefore we propose to study the combination of Avasin,~     Alimta, and Carboplatin administered as front-line therapy to patients with advanced~     nonsquamous non-small cell lung cancer.~   "
251922|NCT00254306|"~     Recreational use of ecstasy (MDMA; 3,4-methylenedioxymethamphetamine) is associated with~     long-lasting effects on metabolism in the human brain. The investigators propose to~     investigate whether chronic use of ecstasy is associated with impairment in motor skills~     and function of the dopaminergic system in recreational users of ecstasy compared with~     healthy volunteers. This will be done by scanning control subjects and ecstasy users at~     baseline and after performing on a motorbike riding computer game, while imaging dopamine in~     vivo with I123-IBZM (a D2 receptor radiotracer), using single photon emission computed~     tomography (SPECT).~   "
251923|NCT00254293|"~     The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in~     subjects with RA.~   "
251924|NCT00254280|"~     The purpose of the study is for recalcitrant hand and foot warts to compare the efficacy of~     treatment with Intense Pulsed Light and paring versus paring alone.~   "
251925|NCT00254267|"~     The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with~     gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.~   "
251926|NCT00254254|"~     This study will be the first evaluation of exenatide in adolescent subjects with type 2~     diabetes mellitus and is designed to evaluate the blood levels of the drug~     (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and~     tolerability of exenatide in these subjects.~   "
251927|NCT00254241|"~     To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode~     schizophrenia~   "
251928|NCT00254228|"~     The purpose of this study is to determine whether the BrainPort™ balance device is safe and~     effective in the treatment of balance disorders in patients with Bilateral Vestibular~     Dysfunction.~   "
251929|NCT00254215|"~     To investigate the hypothesis that reducing the glycemic load of the diet will improve~     changes in body composition and cardio-vascular risk factors. The study compares a~     conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load:~     changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with~     protein, or combining both effects to produce the lowest glycemic load.~   "
251930|NCT00254202|"~     The purpose of this study is to determine the safety and efficacy of iloperidone compared to~     placebo and an active comparator in the treatment of patients with schizophrenia in acute~     exacerbation.~   "
251931|NCT00254189|"~     To determine the ability of a monophasic oral contraceptives (OC) regimen of Levonorgestrel~     (LNG) 90 mg and Ethinyl Estradiol (EE) 20 mg to inhibit ovulation during 84 days of~     continuous therapy.~   "
251955|NCT00253864|"~     The purpose of this prospective database is to investigate the long-term functional status of~     patients who have undergone various types of shoulder surgery. Patients are asked to respond~     to questionnaires prior to surgery and at various post-operative visits in an attempt to~     quantify their functional outcomes. Responses are then linked to other data such as symptoms,~     prior treatments, previous surgery, complications, radiographic results, etc. These data may~     then be used as a basis for devising guidelines for future patients and surgeons.~   "
251932|NCT00254176|"~     Critically ill babies less than 1 month of age have deficient amounts of the antioxidant~     glutathione and a high incidence of disease associated with oxidative injury compared to~     healthy babies. These diseases include but are not limited to damage to the eyes, lungs, and~     intestines. Frequently becoming chronic and potentially life threatening, these diseases~     result in a significantly decreased quality of life to the infant along with increased costs~     to the infant's family and society.~      The amino acid cysteine comprises a third of the tripeptide glutathione and directly~     influences glutathione production. Older children ill with infection and stable, premature~     neonates administered cysteine supplementation to their diet have been previously shown to~     increase their glutathione production and concentrations. Furthermore, cysteine~     supplementation in the ill children resulted in a quicker resolution of their illness.~      Although most critically ill babies require IV nutrition (i.e., TPN) before and during their~     illness, commercially available TPN does not include cysteine as a significant nutrient.~     Cysteine has effectively become a safe and standard supplement to routine TPN in a few major~     hospitals in the U.S.~      The purpose of this study is to evaluate the ability of cysteine supplementation to increase~     glutathione production and concentrations in critically ill babies. Furthermore, the~     investigators want to evaluate whether cysteine supplementation results in less oxidative~     tissue injury and ultimately less severe illnesses. The study will enroll babies admitted to~     the UCLA Medical Center Neonatal Intensive Care Unit (NICU) and they will be chosen at random~     and in a blinded fashion to receive either cysteine or non-cysteine supplementation to their~     routine TPN. Small blood samples along with a single 6 hour infusion of a non-radioactive,~     stable isotope labeled amino acid will be used to measure the production of glutathione as~     well as other compounds in the blood to give a quantitative assessment to the severity of~     illness. Clinical information relevant to the babies' illness and subsequent recovery will be~     recorded.~      The results will be compared between cysteine vs. non-cysteine groups and before vs. after~     individual supplementation. By demonstrating the effect of cysteine supplementation on~     glutathione production, the incidence and/or severity of disease from oxidative injury in~     critically ill babies may be decreased if glutathione production is improved.~   "
251933|NCT00254163|"~     The purpose of this research study is to find out what effects (good and bad) the combination~     of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of~     these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other~     cancers, these combinations are experimental for the treatment of CLL.~   "
251934|NCT00254150|"~     Postoperative organ failures commonly occur after major abdominal surgery and substantially~     increase the utilization of resources and the costs of care, and are favored by tissue~     hypoxia. A therapeutic strategy designed to detect and reverse tissue hypoxia, as diagnosed~     by an increase of oxygen extraction over a pre-defined threshold could decrease the incidence~     of organ failures.~   "
251935|NCT00254137|"~     A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus~     irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in~     first-line treatment of patients with metastatic colorectal cancer.~   "
251936|NCT00254124|"~     The purpose of this study was to determine whether a food portion control tool would be~     effective to result in weight loss in a group of overweight type 2 diabetics. We hypothesized~     that this tool would be effective to induce weight loss in these patients. We also~     hypothesized that diabetic control would be improved in patients using these plates.~   "
251937|NCT00254111|"~     The purpose of this study is to determine whether low level light therapy is effective in the~     treatment of osteoarthritis of the hand, when the treatment is applied to the hand by an~     individual in his or her own home.~   "
251938|NCT00254085|"~     The purpose of the project is to shown whether a little dose of a short acting insulin~     analogue given 3 time daily before the meals compared with placebo could normalise the~     increase in blood glucose after teh meals in diet treated Type 2 diabetic patients.~   "
251939|NCT00254072|"~     Laparoscopic gastric bypass surgery is a common procedure being performed for the treatment~     of morbid obesity. The procedure consists of a creation of a small gastric pouch and~     rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in~     this procedure: the gastrojejunostomy and the jejunojejunostomy. Potential complications~     after gastric bypass include gastrointestinal bleeding and leaks. Gastrointestinal bleeding~     can occur at any staple line including the gastrojejunostomy. Potential methods for~     prevention of postoperative gastrointestinal bleeding include oversewing of the anastomosis~     or the use of a smaller stapler height. We hypothesize that the use of staplers with smaller~     staple height will significantly result in a lower rate of staple line bleeding and possible~     leaks.~   "
251940|NCT00254059|"~     This study will look at an alternative new pathway for diagnosis and treatment based on~     simple procedures in the patient’s own home compared with the current conventional laboratory~     based pathway. The purpose is to determine whether all patients with OSA require the more~     elaborate laboratory procedures, or whether a subgroup can be managed more simply.~   "
251941|NCT00254046|"~     The purpose of this study is research with the goal of evaluating the effect of TMC125 (a~     non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus.~     The study will also investigate whether this new medication is well tolerated, and to further~     confirm that the medication is safe to be used.~   "
251942|NCT00254033|"~     Apathy, or lack of motivation, affects up to 80% of Alzheimer's disease (AD) patients. These~     amotivational symptoms increase patient reliance on caregivers, increase caregiver burden and~     distress, and increase the risk of patient institutionalization. Only 50% of patients with~     apathy respond to current treatment with cholinesterase inhibitors. The mechanism of apathy~     in AD is unknown hampering rational treatment. Our proposed pilot study will provide initial~     data required to develop an amphetamine challenge paradigm to probe the brain reward system.~     These results will be used to develop a larger study evaluating the role of the brain reward~     system in apathy in AD and link this information with pharmacologic treatment. AD is a~     complex neurobiological illness that needs to be understood at several levels to optimize~     treatment. At a neurochemical level, one has to identify the neurotransmitter abnormalities~     that accompany the clinical symptoms. The neurochemical level of analysis provides the link~     between pathology and symptoms and, for now, is the only avenue for biological therapies.~     Next, one has to translate knowledge of neurochemical abnormalities to practical treatments~     for the symptoms of AD. This pilot will allow us to develop a study that can address both of~     these goals. Furthermore, the larger study will further define the emerging concept of apathy~     as a syndrome and has broader implications for apathy in many other neuropsychiatric~     diseases.~   "
251956|NCT00253851|"~     The goal of this study is to prevent blood clots from forming during surgery and a few days~     after total knee replacement surgery. This study will help us identify whether using a blood~     thinner in the operating room will stop blood clots from forming during the operation.~   "
252029|NCT00252876|"~     This is a 107-week open-label, multi-center long-term extension study from GALLANT studies~     2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in~     patients with type 2 diabetes during up to 104 weeks of treatment. The total duration,~     including treatment and follow-up, is 107 weeks.~   "
251943|NCT00254020|"~     Depression is a common and often serious problem occurring in stroke patients. Inflammatory~     hormones, known as cytokines, are stimulated by an activated immune system and sometimes~     become active following a stroke. They may be responsible for altering levels of key~     neurotransmitters and their metabolites in the blood and brain of stroke patients. The~     investigators' objective is to examine whether increased cytokine activity following a stroke~     may be the cause of an increased presence or severity of depression or cognitive impairment~     among stroke patients, as a result of tryptophan depletion and/or kynurenine activation. They~     are recruiting patients within one month of their strokes and measuring levels of key markers~     in their blood. Patients are assessed for the presence of depressive and/or cognitive~     symptoms and treated with an antidepressant if needed. The investigators expect to show that~     cytokine activation is related to depression and/or cognitive impairment among stroke~     patients.~   "
251944|NCT00254007|"~     Problem: Depressive symptoms are a common mental health problem following traumatic brain~     injury (TBI), occurring in up to 87% of patients. Depression following TBI has important~     consequences including poor functioning, lack of ability to return to work and family~     activities and prolonged TBI symptoms. The reason depression develops in some patients~     following TBI is unknown, making treatment difficult.~      One type of brain protein that shows genetic differences between people is called the~     serotonin transporter. People can be divided by whether or not they have a short protein (S~     allele) or a long protein (L allele) which influences the amount of serotonin transporter.~     Serotonin is a key brain chemical in depression in many mental/psychiatric illnesses. We~     think that the genetic differences in the serotonin transporter, that may not make a~     difference before TBI, may become important after TBI due to the nature of these injuries.~      Methods: A consecutive sample of 200 patients attending a TBI clinic who have sustained a~     mild-to-moderate TBI (American Congress of Rehabilitation Medicine criteria) within the last~     2 months will be assessed for the presence of major depression (standard criteria,~     standardized interview). In phase I, blood samples from patients with mild-to-moderate TBI~     with depression and without depression will be checked for the presence of the 5-HTTPR~     genetic difference. This will allow us to study if the S allele is more likely in TBI~     patients with depression. In phase II, the patients with depression will be treated with the~     SSRI citalopram for 6 weeks. At 6 weeks, or upon discontinuation of citalopram, depression~     will be assessed again. This will allow us to study if depressed patients with the S allele~     respond more poorly to treatment. Persons assessing depression after treatment will not know~     the genetic makeup of each patient.~      Results Expected: If the serotonin transporter genetic difference confers susceptibility to~     depression following TBI, this will provide important information on what causes depression~     following TBI and document a risk factor for depression previously unstudied in this~     population. Also, as SSRI antidepressants are used to treat depression in TBI, this study may~     identify a subgroup of TBI patients in whom different medications should be given or~     additional medications are required.~   "
251945|NCT00253994|"~     -  Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS)~        -  Study Period: August 1, 2003 - December 31, 2004~   "
251946|NCT00253981|"~     The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin~     splints, to evaluate healing time and effectiveness.~   "
251947|NCT00253968|"~     The purpose of the study is to assess efficacy and safety of eplivanserin in the population~     of patients complaining of sleep maintenance insomnia. The patients suffering from that~     condition frequently wake up during the night, their sleep is nonrestorative and they suffer~     from a significant distress or impairment in their daily activities consecutive to insomnia.~   "
251948|NCT00253955|"~     Primary Objective:~        -  The primary objective of the study is to demonstrate the non-inferiority in clinical~          efficacy at the test of cure (TOC) visit planned 5-7 days after treatment completion of~          levofloxacin 750 mg once daily (od) in comparison with piperacillin/tazobactam 4 g/500~          mg every 8 hours in treating adult patients suffering from mild to moderate~          hospital-acquired pneumonia.~      Secondary Objectives:~      The secondary objectives of the study are:~        -  To assess the bacteriological efficacy at the test of cure (TOC) visit~        -  To assess the clinical and bacteriological efficacy at the end of study (EOS) visit, 28~          to 32 days after treatment ends~        -  To assess the tolerability of both drugs~   "
251949|NCT00253942|"~     Study wishes to determine if the use of injectable bee venom is a safe and effective~     treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased~     report of pain and discomfort, increased function during daily activities, decrease use of~     analgesic meds, and improvement in walking and climbing steps. We will be using histamine as~     a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and~     histamine. Each injection of bee venom dosage will consist of 100 micrograms of dried bee~     venom in 0.1 ml. of 0.5% preservative free Xylocaine. The histamine dosage will consist of~     .0025 milligrams of histamine in 0.5% preservative free Xylocaine. Subjects will visit the~     study center for 14 visits over an 18 week span. The clinical hypothesis is that bee venom is~     an effective treatment for Osteoarthritis and will reduce pain and discomfort, increase range~     of motion, increase daily function, decrease walking and stair climbing time, and decrease~     the need of analgesic medication for a period of time beyond treatment (after the study has~     concluded.) The clinical safety hypothesis is that for persons not allergic to bee venom~     (patients allergic will not be allowed to enter into the study) the side effects will be~     small. The most common side effects for bee venom and histamine will be redness and itchiness~     which will be tolerable and safe.~   "
251950|NCT00253929|"~     The endogenous nucleoside adenosine can induce various cardiovascular and neurohumoral~     effects by stimulation of specific adenosine receptors. taken together these effects protect~     against ischaemia-reperfusion injury of (myocardial)muscles and agsinst the development of~     atherosclerosis. Genetic variations in genes encoding for adenosine receptors or for enzymes~     involved in the formation or breakdown of adenosine could potentially modulate these effects.~     In this study, we aim to determine the functional effects of two frequent genetic~     polymorphisms in the adenosine receptor and AMPdeaminase (involved in the formation of~     adenosine) on the vascular effects of adenosine.~   "
251951|NCT00253916|"~     Androgen Deprivation Therapy is a commonly used treatment for men with Prostate Cancer.~     Unfortunately this can lead to functional decline, fatigue, increased body fatness, loss of~     lean body tissue and impaired QOL. Previous research has demonstrated the exercise can may~     reduce fatigue and improve QOL in men on ADT. This study will evaluate whether aerobic versus~     resistance exercise over a 24 week period of training will reduce morbidity and improve QOL~     in men receiving radiation plus or minus ADT with curative intent~   "
251952|NCT00253903|"~     The purpose of the study is to assess efficacy and safety of eplivanserin in the population~     of patients complaining of sleep maintenance insomnia. The patients suffering from that~     condition frequently wake up during the night, their sleep is nonrestorative and they suffer~     from a significant distress or impairment in their daily activities consecutive to insomnia.~   "
251983|NCT00253474|"~     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon~     alfa-2b in treating young patients with plexiform neurofibroma.~   "
251957|NCT00253838|"~     This study compares two different hip stem components. Both hip stems used in this study~     allow the femur bone to attach and grow into them for stability. The main difference between~     the two stems is that one of the stems, the Solution® Stem, is made from Cobalt Chrome, a~     type of metal, and does not have a hydroxylapatite (HA) coating, while the second stem~     included in the study, the Restoration hip stem, is made from titanium alloy, a different~     type of metal that has a roughened surface and allows for a hydroxylapatite (HA) coating to~     be applied to the entire length of the stem. The HA coating is a thin calcium phosphate layer~     on the stem to encourage the bone to grow into it. We are trying to see if there is any~     difference in the initial bony ingrowth between the two stems and to compare the results in~     patients over the first two years after the surgery and then again at the five-year period.~   "
251958|NCT00253825|"~     The purpose of the current study is to evaluate relative efficacy of (1)modified~     constraint-induced movement therapy (mCIMT) combined with eye patching, (2)mCIMT, and (3)~     traditional rehabilitation on motor, attentional, and activities of daily living functions in~     stroke patients with unilateral neglect (UN). UN represents a failure to respond or orient to~     stimuli presented contralateral to a brain lesion. Constraint-induced movement therapy is~     made up of a family of treatment that involve repeatedly practicing use of the affected limb~     and constraining use of the unaffected arm in the clinic and at home. mCIMT is an~     intervention based on modifications to conventional CIMT by distributing practice sessions to~     a longer period of time. mCIMT attempts to supplement the inadequacy of the current~     rehabilitation programs and to fit better into rehabilitation schedules. This technique has~     been suggested to be especially relevant for treatment of patients with UN.Half-field eye~     patching involves occlusion of the hemifield of both eyes (in the case of left UN, the right~     hemifields of both eyes). Patching the ipsilateral hemifield is believed to increase~     activation of the involved hemisphere, resulting in increased attention to the contralateral~     neglected side.~      Despite the promising relevance of mCIMT for rehabilitation of patients with hemiplegia, it~     remains unclear whether mCIMT is effective for alleviating UN. A further issue that warrants~     investigation is the combined effects of mCIMT and eye patching. Both approaches involve the~     use of controlled sensory input that may lead to increased activation of the lesioned~     hemisphere. Integration of both approaches may be more efficacious than mCIMT without direct~     intervention for UN. This project is proposed to study the combined effects of both~     approaches. It is hypothesized that combining both approaches will be more effective than~     mCIMT, which is hypothesized to be superior to traditional rehabilitation involving the same~     amount of therapy time. To test the hypotheses, 60 patients with unilateral stroke and UN~     will be recruited and randomly assigned to one of the three treatment groups (i.e., mCIMT and~     eye patching, mCIMT, and traditional rehabilitation). Testing for UN will include the use of~     the line bisection test, cancellation tasks, and examination for extinction to double~     simultaneous stimulations.~      The outcome measures will include traditional motor function tests, kinematic analysis, a~     circle discrimination test, and daily life functional measures. Each eligible participant~     will be tested before and immediately after the assigned intervention and at three months and~     six months after the treatment. Each type of treatment will be three-week long. Multivariate~     analysis of covariance will be used to analyze the obtained data in order to test for the~     relative effects of the three treatments. Each participant will be tested for motivation for~     participating in treatment sessions using the Pittsburgh Rehabilitation Participation Scale.~     It is hypothesized that patients with higher participation will improve more than those with~     lower participation.~      The uniqueness of this proposed project pertains to (1)modification of the CIMT protocol in a~     more feasible way; (2)concurrent use of mCIMT and eye patching for treating UN post stroke;~     and (3)use of kinematic analysis for detecting precise changes in motor behavior post~     intervention. Kinematic analysis is relevant for identifying trajectory control deficits that~     may accompany clinically “recovered” UN. Findings of this investigation will improve~     assessment and treatment for UN that is devastating to functional recovery from stroke.~   "
251959|NCT00253812|"~     The purpose of this study is to establish whether new techniques that may make polyps~     (adenomas) stand out better from the background help increase the number of polyps visible at~     sigmoidoscopy (telescope test to look inside large bowel) compared to looking with standard~     sigmoidoscopy alone.~   "
251960|NCT00253799|"~     The objective is to assess the safety and efficacy (over the course of 26 weeks) of 2~     intra-articular (IA) Hylan GF-20 (Synvisc) injections in addition to customary care in~     patients with painful glenohumeral osteoarthritis.~   "
251961|NCT00253786|"~     Study for the effectiveness of intensive therapy aiming at the remission of diabetic~     nephropathy~   "
251962|NCT00253773|"~     This pilot study tests the feasibility of using GSH redox state and high resolution proton~     NMR spectroscopy (1H-NMR) to detect metabolic changes due to acetominophen and sulfur amino~     acid deficiency. Our central hypothesis is that the a 2-day sulfur amino acid deficiency will~     alter acetominophen metabolism, acetominophen will affect sulfur amino acid homeostasis, and~     the treatments together will alter the global metabolic profile, as measured by 1H-NMR~     spectroscopy.~   "
251963|NCT00253760|"~     Varied food intake, disease, and genetic differences result in complex diet-health~     interactions. In principle, information-rich metabolic analyses combined with bioinformatic~     tools provide an approach to explore these interactions. This project is a feasibility study~     of the use of high-resolution 1H-nuclear magnetic resonance (NMR) to study metabolic~     perturbations induced by a deficiency in sulfur amino acids (SAA). The investigators will 1)~     test the hypothesis that deficient dietary intake of SAA in humans results in oxidation of~     reduced glutathione (GSH)/oxidized glutathione (GSSG) redox and 2) determine whether 1H-NMR~     of blood and urine detects metabolic changes due to SAA deficiency.~   "
251964|NCT00253747|"~     The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS~     MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e.,~     nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence~     for smokers with Attention Deficit Hyperactivity Disorder (ADHD).~   "
251965|NCT00253734|"~     The purpose of this research study is to find out if giving the smaller dose of flu vaccine~     under the skin generates antibodies against flu compared to giving the vaccine the usual way,~     as a shot in the arm. If using smaller doses in this manner is effective, the current supply~     of vaccine could be used to make more doses to give to more people. About 217 healthy adults,~     18 to 49 years of age, will participate. The study will be conducted at one site in the~     United States and subjects are expected to participate for about 6 months. Blood samples will~     be taken to assess the immune system response. Local and systemic safety will be evaluated in~     the 28 days following vaccination.~   "
251966|NCT00253721|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     drugs directly into the arteries around the tumor may kill more tumor cells. Mannitol may~     open the blood vessels around the brain [Blood-Brain Barrier Disruption (BBBD)]and allow~     melphalan to be carried directly to the brain tumor. Giving melphalan together with BBBD may~     be an effective treatment for central nervous system cancer.~      PURPOSE: This phase I trial is studying side effects and best dose of melphalan when given~     together with mannitol in treating patients with central nervous system cancer.~   "
251967|NCT00253708|"~     RATIONALE: Massage therapy may help relieve symptoms associated with cancer. It is not yet~     known which type of massage therapy is more effective in treating the symptoms of patients~     with cancer.~      PURPOSE: This randomized clinical trial is studying different types of massage therapy to~     compare how well they work in treating the symptoms of patients with locally advanced or~     metastatic cancer.~   "
251968|NCT00253695|"~     This study is a first step in approaching the gap existing between understanding sleep~     abnormalities, alterations in sleep-regulating cytokines and HIV-1 disease regulating~     cytokines, and abnormal higher cortical function.~   "
251969|NCT00253682|"~     This study will determine the impact of highly active antiretroviral therapy (HAART) on the~     developing cardiovascular system, the evolution of HAART-associated cardiovascular changes~     over time, and the association between cardiovascular measurements with HAART exposure.~   "
251970|NCT00253669|"~     RATIONALE: Patients with gliomas may be at risk for developing blood clots. Learning about~     the risk factors for developing blood clots may help doctors plan better treatment for~     gliomas.~      PURPOSE: This clinical trial is studying risk factors for developing blood clots in patients~     who are undergoing cancer treatment for newly diagnosed gliomas.~   "
251971|NCT00253643|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of fish oil and/or green tea may prevent prostate cancer.~      PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea~     supplement works in preventing prostate cancer in patients with prostatic intraepithelial~     neoplasia or who are at risk for developing prostate cancer.~   "
251972|NCT00253630|"~     This phase II trial is studying how well vorinostat works in treating patients with relapsed~     or refractory indolent non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as~     vorinostat, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
252422|NCT00247624|"~     This study will evaluate the safety and effectiveness of treatment with both a sleeping pill~     and antidepressant medication in improving sleep and psychological functioning in people with~     depression and insomnia.~   "
251973|NCT00253617|"~     RATIONALE: Stent placement may help reduce symptoms caused by the tumor. Photodynamic therapy~     uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain~     kind of light. When the drug is active, tumor cells are killed. This may be an effective~     treatment for cholangiocarcinoma. It is not yet known whether stent placement and~     photodynamic therapy using porfimer sodium are more effective than stent placement alone in~     treating cholangiocarcinoma.~      PURPOSE: This randomized phase III trial is studying stent placement and photodynamic therapy~     using porfimer sodium to see how well they work compared to stent placement alone as~     palliative treatment in treating patients with stage III or stage IV cholangiocarcinoma that~     cannot be removed by surgery.~   "
251974|NCT00253591|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as vinorelbine and cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet~     known whether giving radiation therapy together with vinorelbine and cisplatin is more~     effective than radiation therapy alone in treating non-small cell lung cancer.~      PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy~     together with vinorelbine and cisplatin works and compares it to radiation therapy alone in~     treating patients with stage I, stage II, or stage III non-small cell lung cancer.~   "
251975|NCT00253578|"~     This phase II trial is studying how well sorafenib works in treating patients with relapsed~     or refractory multiple myeloma. Sorafenib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth and by blocking blood flow to the cancer~   "
251976|NCT00253565|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving imatinib mesylate~     together with capecitabine may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate~     when given together with capecitabine in treating patients with advanced solid tumors.~   "
251977|NCT00253552|"~     RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow~     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as~     G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can~     be collected and stored.~      PURPOSE: This clinical trial is studying how well a G-CSF-treated donor bone marrow~     transplant works in treating patients with hematologic cancer or noncancer.~   "
251978|NCT00253539|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     arzoxifene or tamoxifen may prevent breast cancer by lowering the amount of estrogen the body~     makes. The use of arzoxifene or tamoxifen may keep breast cancer from forming in women at~     high risk for breast cancer.~      PURPOSE: This randomized phase II trial is studying arzoxifene to see how well it works~     compared to tamoxifen or a placebo in preventing breast cancer in premenopausal women at high~     risk for breast cancer.~   "
251979|NCT00253526|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine~     hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells.~      PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how~     well they work compared to gemcitabine hydrochloride alone in treating patients who are~     undergoing surgery for pancreatic cancer.~   "
251980|NCT00253513|"~     RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving treosulfan and fludarabine together with a donor bone marrow transplant or a~     peripheral stem cell transplant may be an effective treatment for acute myeloid leukemia,~     acute lymphoblastic leukemia, or myelodysplastic syndrome.~      PURPOSE: This phase II trial is studying giving treosulfan together with fludarabine to see~     how well it works in treating patients who are undergoing a donor stem cell transplant for~     acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.~   "
251981|NCT00253500|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~      PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are~     undergoing surgery for stage I, stage II, or stage III breast cancer.~   "
251982|NCT00253487|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, busulfan, and O6-benzylguanine,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. O6-benzylguanine may also help temozolomide work better by making tumor~     cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor~     cells. Giving chemotherapy with a peripheral stem cell transplant or bone marrow transplant,~     using stem cells from the patient that are genetically-modified in the laboratory to protect~     them from the side effects of chemotherapy, may allow more chemotherapy to be given so that~     more tumor cells are killed. Giving combination chemotherapy and radiation therapy together~     with a peripheral stem cell transplant or bone marrow transplant may kill more tumor cells.~      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together~     with radiation therapy works in treating younger patients who are undergoing an autologous~     stem cell transplant for newly diagnosed gliomas.~   "
251985|NCT00253448|"~     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor~     cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together~     with radiation therapy works in treating patients with glioblastoma multiforme.~   "
251986|NCT00253435|"~     RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry~     radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such~     as carboplatin, etoposide, and melphalan, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. An autologous peripheral stem cell or bone marrow~     transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and~     radiation therapy. Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy~     with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy~     to be given so that more tumor cells are killed. Giving radiation therapy after an autologous~     peripheral stem cell or bone marrow transplant may kill any remaining tumor cells.~      PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine~     together with combination chemotherapy and radiation therapy works in treating patients who~     are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or~     refractory neuroblastoma.~   "
251987|NCT00253422|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of~     estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not~     yet known whether giving fulvestrant together with anastrozole is more effective than giving~     fulvestrant together with a placebo or exemestane alone in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how~     well they work compared to fulvestrant and a placebo or exemestane alone in treating~     postmenopausal women with locally advanced or metastatic breast cancer.~   "
251988|NCT00253409|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the~     tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor~     cells that remain after surgery. It is not yet known whether combination chemotherapy is more~     effective with or without surgery and radiation therapy in treating mesothelioma.~      PURPOSE: This randomized clinical trial is studying combination chemotherapy, surgery, and~     radiation therapy to see how well they work compared to combination chemotherapy alone in~     treating patients with mesothelioma that can be removed by surgery.~   "
251989|NCT00253396|"~     The purpose of this study is to determine which short-acting blood thinner~     (low-molecular-weight heparin [Enoxaparin] or unfractionated heparin) is associated with less~     discomfort and bruising when given as a subcutaneous (under the skin) injection before and~     after a planned surgery or procedure in patients who temporarily stop warfarin.~   "
251990|NCT00253383|"~     RATIONALE: Palliative care may help patients with advanced cancer live more comfortably.~      PURPOSE: This randomized clinical trial is studying an early intervention palliative care~     program to see how well it works compared to a standard care program in improving end-of-life~     care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.~   "
251991|NCT00253370|"~     This phase II trial is studying how well giving sorafenib together with docetaxel and~     cisplatin works in treating patients with metastatic or locally advanced gastric or~     gastroesophageal junction cancer that cannot be removed by surgery. Sorafenib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking~     blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving sorafenib together with docetaxel and cisplatin may kill more~     tumor cells.~   "
251992|NCT00253357|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. Using a~     medical device like a pacemaker or a defibrillator can help the heart to pump in regular~     beats. However, not all patients do better with a device. Currently, there is not a way to~     identify which patients will benefit from the device. The purpose of this study is to~     determine if using medical tests, Echocardiogram, can help in predicting which patients will~     improve. The types of patients needed for this study are those who have been diagnosed with~     moderate or severe heart failure.~   "
251993|NCT00253344|"~     RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the~     tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     lenalidomide together with docetaxel may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when~     given together with docetaxel in treating patients with advanced solid tumors.~   "
251994|NCT00253331|"~     The purpose of this study is to determine, in comparison to a placebo control, the response~     to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the~     determination of finger blood flow and skin temperature in the fingers of patients with~     moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.~      Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured~     using attached thermistor probes. Following baseline measurements, the study gel is applied,~     the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored~     for the next two hours.~      Each patient will receive multiple doses on different days so that each can serve as his/her~     own control in interpreting the response.~   "
252030|NCT00252863|"~     The purpose of this study is to determine whether Symbicort dosed according to the Symbicort~     Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment~     according to the local German treatment guidelines.~   "
252448|NCT00247273|"~     The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as~     compared to the standard daily dosing regimen of risedronate 5 mg daily.~   "
251995|NCT00253318|"~     Primary:~        -  To assess the safety and tolerability and to find the maximum tolerated dose of the~          combination administration of RAD001 plus docetaxel when given to patients with~          metastatic breast cancer who are being considered for standard docetaxel treatment~          (phase I).~        -  To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase~          I).~      Secondary:~        -  To determine the phosphorylation status of the components of the mTOR signaling pathway~          and the expression of modifiers of apoptosis in the primary breast tumors, in order to~          determine whether these markers can be used as predictors of sensitivity to the~          combination of RAD001 and docetaxel~        -  To determine the effect of the combination of RAD001 and docetaxel on the expression and~          phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify~          potential pharmacodynamics markers of response to this drug combination~   "
251996|NCT00253305|"~     The purpose of this study is to compare, in a controlled fashion, the response to two~     anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations~     in the treatment of subjects with distal subungual tinea unguium of the toenails~     (onychomycosis).~      The formulation used as the vehicle for the active agents has been shown in earlier studies~     to facilitate the penetration of the active agent through fungally-infected nails. This study~     will examine dose-response and agent differences in terms of efficacy and safety.~      Once the subject has qualified for the study, he/she will be randomly assigned to one of five~     study groups, dispensed appropriate study medication and instructed to apply one drop to the~     great toe designated for study.~   "
251997|NCT00253292|"~     The purpose of this study is to develop a standardized, practical self-administered~     questionnaire to monitor young adult burn patients and to evaluate the effectiveness of burn~     management treatments with regard to improved function, physical appearance and other~     relevant outcomes.~   "
251998|NCT00253279|"~     Our specific aim is to gain an understanding of protein synthesis rates in burn patients at~     various times during their injury and recovery by using PET scans. This will be compared with~     healthy volunteer controls. We hope this will help optimize nutrition and care regimens for~     future burn patients.~   "
251999|NCT00253266|"~     This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic~     quetiapine in treatment resistant depression.~   "
252000|NCT00253253|"~     The purpose of this study is to determine the long-term outcome in congenital undescended~     testis after surgical treatment by orchidopexy and to what extent orchidopexy is the~     treatment for congenital undescended testis.~   "
252001|NCT00253240|"~     Family physicians are the primary health care providers for complex patients such as persons~     with serious mental illness. The psychiatric needs of these patients could take attention~     away from management of health problems and from usual health promotion services. For~     example, Schizophrenia is associated with a higher than normal incidence of diabetes, and~     first line treatments of Schizophrenia have also been found to increase risk for diabetes. As~     such, this high-risk group requires targeted diabetes strategies. In London Ontario, services~     are provided to this high risk mental health population primarily by two community agencies:~     The Western Ontario Therapeutic Community Hostel (WOTCH) and the Canadian Mental Health~     Association (CMHA). Accordingly, the goal of this project is to assess how these patients are~     currently being managed by their family physicians and to pilot a community-based,~     multidisciplinary diabetes clinic model within this population. If this delivery model proves~     feasible and effective, family physicians could be assisted by existing community agencies in~     the management of their patients’ diabetes and patients will receive improved access to this~     vital multidisciplinary team.~   "
252002|NCT00253227|"~     The purpose of this study is to evaluate the safety and effectiveness of galantamine (a drug~     for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease~     using a flexible dose design.~   "
252003|NCT00253214|"~     The purpose of this study is to evaluate the safety and effectiveness of a once daily~     controlled-release form of galantamine (a drug for treating dementia) versus placebo in the~     treatment of patients with Alzheimer's disease.~   "
252004|NCT00253201|"~     The purpose of this study is to evaluate the safety and effectiveness of two doses of~     galantamine (a drug for treating dementia) versus placebo in the treatment of patients with~     Alzheimer's disease.~   "
252005|NCT00253188|"~     The purpose of this study is to evaluate the safety and effectiveness of two doses of~     galantamine (a drug for treating dementia) versus placebo in the treatment of patients with~     Alzheimer's disease.~   "
252006|NCT00253175|"~     The primary purpose of this study is to evaluate the effectiveness and safety of topiramate~     (an epilepsy medication) compared with placebo in the prevention of migraine.~   "
252007|NCT00253162|"~     The purpose of the study is to assess the effectiveness and safety of risperidone (an~     antipsychotic medication) compared with placebo after 3 weeks of treatment in patients with~     bipolar disorder who are experiencing manic episodes. A secondary purpose of the study is to~     assess the maintenance of risperidone effectiveness versus haloperidol (an antipsychotic~     medication) after 12 weeks of treatment.~   "
252008|NCT00253149|"~     The purpose of the study is to evaluate the effectiveness and safety of risperidone (an~     antipsychotic medication) versus placebo as add-on therapy to mood stabilizers in the~     treatment of manic episodes associated with bipolar disorder.~   "
252009|NCT00253136|"~     The purpose of the study is to compare the effectiveness and safety of a long-acting~     injectable formulation of risperidone (an antipsychotic medication) versus placebo for the~     treatment of the symptoms of schizophrenia over a 12-week period.~   "
252010|NCT00253123|"~     The purpose of the study is to evaluate the safety and efficacy of risperidone (an~     antipsychotic medication) versus placebo in the treatment of behavioral disturbances~     associated with dementia.~   "
252011|NCT00253110|"~     The purpose of the study is to compare the time to relapse in patients with schizophrenia and~     schizoaffective disorders receiving risperidone or haloperidol (antipsychotic medications)~     for at least 1 year.~   "
252072|NCT00252317|"~     Abundant evidence suggests that Angiotensin Converting Enzyme (ACE) inhibition potentially~     could reduce the hazardous effects of aortic stenosis and improve haemodynamics. The~     treatment seems safe even in patients with severe stenosis. There are however no randomised~     clinical trials that can confirm this hypothesis.~   "
252012|NCT00253097|"~     Patients with a diagnosis of stroke or TIA, who are already included in the RIALTO-cohort~     study are asked to participate in a RCT after discharge from hospital.~      Patients in the intervention group will receive four visits by a study nurse with the aim of~     controlling the patient's hypertension, reducing risk factors like tobacco smoking and~     obesity, and motivating the patient to physical activity and to a healthy diet.Patients in~     the control group will receive the usual treatment.~      This study is aimed at testing the hypothesis, that~      Primary outcome: the blood pressure lowering will be greater in the intervention group~     Secondary outcomes: the blood pressure will be lower in the intervention group and the number~     of patients who have stopped smoking will be greater in the intervention group The number of~     obese patients who have reduced their BMI will be greater in the intervention group The~     number of patients with a Rankin Scale<3 who are physically active for four hours a week will~     be greater in the intervention group Time to recurrent stroke, MI and death will be longer in~     the intervention group~      Outcomes are measured by follow up visit one and two years after inclusion in the study~      Expected Total Enrollment: 342 in the RCT, 1200 in the cohort~      Study Start: 011205 (PREVENT) Study Completion: January 2009(PREVENT), September 2013 (RIALTO~     Cohort study)~   "
252013|NCT00253084|"~     The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release~     carbidopa-levodopa in subjects with Parkinson's disease.~   "
252014|NCT00253071|"~     The purpose of this study is to determine whether early integrated prophylactic combined~     medical and psychological outpatient treatment is associated with a better prognosis in~     patients with severe unipolar and bipolar affective disorders than standard treatment.~   "
252015|NCT00253058|"~     To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom~     score (TNSS) over the total treatment period from the score of the baseline assessment period~   "
252016|NCT00253045|"~     The purpose of this study is to determine if a group motivational interviewing based~     intervention will increase adherence to antiretroviral medications and use of risk reduction~     behaviors.~   "
252017|NCT00253032|"~     The study is being performed to determine the efficacy and safety of Fralex Neuromodulation~     Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal~     pain.~   "
252018|NCT00253019|"~     This study will assess the continuation rates among women using oral contraceptive pills,~     Depo-Provera and Ortho Evra following a first trimester abortion.~   "
252019|NCT00253006|"~     Painful bladder syndrome (PBS)/interstitial cystitis (IC) may be due to the actions of nitric~     oxide (NO) in the bladder tissue. NO is a gaseous substance with a very short half-life,~     synthesized by a group of NO-synthase-enzymes in many tissues.~      The goal of this study is to illuminate bladder tissue production of NO in individuals with~     PBS and healthy individuals, by quantification of NO and NO-enzyme expression by different~     molecular biological methods.~   "
252020|NCT00252993|"~     This is a randomized, double blind, placebo controlled, multicenter study designed to assess~     the safety and efficacy of DDP225 in patients with chronic functional vomiting. Male or~     female patients from 18 to 65 years of age with a functional vomiting history for at least 12~     weeks in the preceding 12 months or cyclic vomiting history with at least 3 episodes in the~     previous 12 months are eligible. A total of 30 eligible patients with chronic functional~     vomiting will be enrolled.~      The total duration of study participation for an individual patient is approximately 15 weeks~     (105 days) from the initial screening visit to final study evaluations. The total duration of~     dosing with study medication (either DDP225 or placebo) is 12 weeks.~      Patients who satisfy all of the inclusion criteria and none of the exclusion criteria are~     eligible to enter the Treatment Period and will be randomly assigned to one of three~     treatment groups.~      After a patient is randomized and enters the Treatment Period, he/she will take the~     appropriate study medication once a day for 84 days and return to the clinic at two week~     intervals for a total of six visits during the Treatment Period. During the Treatment Period,~     patients will maintain a daily diary and complete questionnaires. One week after completing~     the 84-day Treatment Period, patients return to the clinic for final safety evaluations which~     include a physical examination, electrocardiogram, and clinical laboratory testing.~   "
252021|NCT00252980|"~     The purpose of this study is to develop a modular treatment program for cannabis use~     disorders and the evaluation of the effectiveness in a controlled clinical study.~   "
252022|NCT00252967|"~     The purpose of this study is to test whether the drug, atorvastatin, will be able to reduce~     the rate of return of the abnormal beats after using cardioversion. Atorvastatin is a drug~     approved by the Food and Drug Administration (FDA) for the treatment of high cholesterol but~     is not approved for preventing abnormal heartbeats. In addition to lowering cholesterol, the~     drug reduces inflammation. Inflammation seems to help cause atrial fibrillation, a certain~     type of abnormal heartbeat. In animals, atorvastatin reduces the risk of this type of~     abnormal beats, and preliminary data in humans supports an effect of atorvastatin and other~     similar drugs that have the same action on reducing the risk of this type of abnormal beats.~     We, the researchers at Emory University, would like to learn if this drug could prevent the~     return of these abnormal heartbeats.~   "
252023|NCT00252954|"~     Purpose: To evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain~     after spinal cord injury, and to examine its effect on spasms and evoked pain.~   "
252024|NCT00252941|"~     The purpose of this study is to determine the feasibility, safety, and efficacy of the~     Memokath® 028SW stent to prevent urinary obstructive symptoms (difficulty urinating) when~     used after prostate seed implantation for the treatment of localized prostate cancer.~   "
252025|NCT00252928|"~     The purpose of this study to determine whether Aquatabs, a water treatment tablet, reduces~     diarrheal diseases in a peri-urban population of Tamale, Ghana.~   "
252026|NCT00252915|"~     There is basic science evidence that GM-CSF reconstructs cellular immunity in septic~     patients. In this prospective, randomised double-blind, placebo-controlled trial, we~     investigate whether this can be achieved in patients with severe sepsis and septic shock.~   "
252027|NCT00252902|"~     The primary purpose of the study is to refine the intervention protocols for two ED-initiated~     tobacco interventions and to assess the magnitude of the effect size that can be expected. We~     expect the intervention groups to have greater sustained abstinence, point-prevalence~     abstinence, and motivation to change when compared to the treatment as usual group at 1- and~     3-month follow-up.~   "
252031|NCT00252850|"~     This is a Phase I dose escalating open-label study designed to assess the safety,~     tolerability and biologic activity of an in vivo AAV2 mediated delivery of the gene encoding~     NTN (CERE-120).~      Twelve (up to 18) subjects will receive one of two open-label doses of CERE-120 via bilateral~     stereotactic injections targeting the putaminal region of the brain. Subjects will be~     enrolled in one of two cohorts, a low-dose cohort of six subjects followed by a high dose~     cohort of six subjects.~      The design of this study is such that the primary objective, the evaluation of safety and~     tolerability, will be assessed by frequent observations for adverse events, clinical~     laboratory test results, imaging (MRI), neuropsychometric testing, and evaluations of disease~     status.~   "
252032|NCT00252837|"~     This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled~     study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately~     controlled on diet and lifestyle advice alone during the run-in period. The study comprises a~     6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week~     follow-up period.~      The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT~     2 will be transferred to the GALLANT 22 database and will be analyzed together with the data~     from GALLANT 22 clinical study.~   "
252033|NCT00252824|"~     The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with~     conventional stepwise treatment according to asthma treatment guidelines in patients with~     persistent asthma~   "
252034|NCT00252811|"~     This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with~     histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative~     (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to~     receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical~     intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week~     after surgery.~   "
252035|NCT00252798|"~     The primary objective of the trial is to determine the Maximum tolerated dose, if any, of the~     combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up~     to 45 mg/m2 paclitaxel.~   "
252036|NCT00252785|"~     The primary objective of this study is to confirm the efficacy (superiority) of Symbicort®~     Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg~     twice daily + Theolong® tablet 200 mg twice daily.~   "
252037|NCT00252772|"~     This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled~     study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately~     controlled on diet and lifestyle advice alone during the run-in period. The study comprises a~     6-week single-blind placebo run-in period followed by 24-week treatment period and a 3-week~     follow-up period.~      The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT~     2 will be transferred to the GALLANT 22 database and will be analyzed together with the data~     from GALLANT 22 clinical study.~   "
252038|NCT00252759|"~     The purposes of this study are:~        -  To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with~          gefitinib as compared to other chemotherapy treatment, and to assess the risk factors~          for ILD in advanced/recurrence NSCLC patients undergoing treatment~        -  To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC~          patients undergoing treatment~   "
252039|NCT00252746|"~     To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day~     respectively~   "
252040|NCT00252733|"~     The primary objective is to determine whether candesartan, compared to placebo reduces the~     incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients~     without retinopathy.~      The secondary objective is to determine whether candesartan, compared to placebo,~     beneficially influences the rate of change in urinary albumin excretion rate (UAER).~      This study is part of the DIRECT Programme also including secondary prevention studies of~     diabetic retinopathy in both type 1 and type 2 diabetes. The primary objective for all three~     pooled studies is to determine whether candesartan, compared to placebo, reduces the~     incidence of microalbuminuria in type 1 and type 2 diabetic patients.~   "
252041|NCT00252720|"~     The primary objective is to determine whether candesartan, compared to placebo reduces the~     progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic~     patients with retinopathy.~      The secondary objective is to determine whether candesartan, compared to placebo, reduces the~     incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic~     retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion~     rate (UAER).~      This study is part of the DIRECT Programme also including a primary prevention study of~     diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes.~     The primary objective for all three pooled studies is to determine whether candesartan,~     compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic~     patients.~   "
252042|NCT00252707|"~     In this study, among the patients with non-small cell lung cancer, those with metastasis or~     recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and~     we will compare the effectiveness and safety of gefitinib with docetaxel.~   "
252043|NCT00252694|"~     The primary objective is to determine whether candesartan, compared to placebo reduces the~     progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with~     retinopathy.~      The secondary objective is to determine whether candesartan, compared to placebo, reduces the~     incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic~     retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion~     rate (UAER).~      This study is part of the DIRECT Programme also including a primary prevention study of~     diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes.~     The primary objective for all three pooled studies is to determine whether candesartan,~     compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic~     patients.~   "
252044|NCT00252681|"~     The primary purpose of this study is to compare two surgical treatments for perforated~     necrotizing enterocolitis in very low birth weight babies.~   "
252045|NCT00252668|"~     This study is an open label extension of a previously completed double-blind, randomized~     study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All~     subjects will receive combination treatment with etanercept and methotrexate.~   "
252046|NCT00252655|"~     The purpose of this study is to evaluate the efficacy of Sirolimus (Rapamune) in improving~     the function of the transplant kidney, without any increase in the risk of acute rejection or~     adverse side effects, compared with Tacrolimus (Prograf).~      We hypothesize that Sirolimus, as one component of a long-term steroid-free immunosuppressive~     regimen, will be effective in maintaining a low incidence of acute rejection and a short- and~     long-term graft survival comparable to Tacrolimus with better graft function in the high-risk~     African-American renal transplant population with immediate graft function.~   "
252047|NCT00252642|"~     The primary purpose of this study is to determine if peginterferon alpha-2a maintenance~     therapy (90 mcg/week) will lower portal pressure in patients with hepatitis C virus~     infections and advanced fibrosis or cirrhosis.~   "
252048|NCT00252629|"~     The purpose of this study is to determine any sleep disordered breathing in veterans with~     Gulf War Syndrome (GWS) and compare it to healthy normal asymptomatic Gulf War veterans. This~     study will also determine the effect of treatment with continuous positive airway pressure on~     veterans with Gulf War Syndrome.~        1. The investigators hypothesize that sleep complaints (insomnia, un-refreshing sleep and~          daytime fatigue) among GWS patients are related to increased sleep fragmentation~          secondary to the presence of sleep disordered breathing in GWS patients.~        2. The investigators hypothesize that increased collapsibility of the upper airway during~          sleep with the development of inspiratory flow limitation (IFL) and sleep disordered~          breathing causes the increased sleep fragmentation in GWS patients.~        3. The investigators hypothesize that correction of IFL and sleep disordered breathing in~          GWS patients will result in an improvement of their sleep quality resulting in an~          improvement of their sleep complaints and other functional symptoms.~   "
252049|NCT00252616|"~     This study tests the hypothesis that initial trophic enteral feedings will increase the time~     alive and free of mechanical ventilation as compared to initial goal enteral feedings in~     patients who are mechanically ventilated.~   "
252050|NCT00252603|"~     Autism is a severe neurodevelopmental disorder that affects up to 16 in 10,000 individuals.~     It is a pervasive developmental disorder affecting social, communicative, and~     compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements,~     craving for sameness, and narrow repetitive interests. Autism severely impacts both the~     affected individual and family members.~      The proposed study is designed to assess the efficacy of treatment with Galantamine vs.~     placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview~     (ADI) criteria. We therefore hypothesize:~        1. Galantamine will be superior to placebo in the acute treatment of global autism.~        2. Galantamine will be superior to placebo in improving functional ability.~        3. Galantamine will be superior to placebo in improving language function.~        4. Galantamine will be superior to placebo improving irritable and hyperactive behavior.~        5. Galantamine will be superior to placebo in improving social deficits.~   "
252051|NCT00252590|"~     The purpose of this study is to determine whether a health focused motivational intervention~     will reduce alcohol use for dependent veterans who are receiving outpatient alcohol and drug~     treatment.~   "
252052|NCT00252577|"~     The purpose of this study is to identify genetic predictors of lithium response in bipolar~     disorder.~   "
252053|NCT00252564|"~     The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12~     months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first~     line treatment of metastatic colorectal cancer.~   "
252054|NCT00252551|"~     Study to evaluate the superiority of the osteosynthesis associated with a decompressive~     surgery in comparison with a simple decompressive surgery in the treatment of lumbar~     degenerative stenosis with spondylolisthesis~   "
252055|NCT00252538|"~     The purpose of this study is to identify predictors and associated biochemical markers of~     interferon-induced depression. It is hypothesized that genetic variation in genes related to~     the serotonergic system may predict vulnerability to interferon-induced depression.~   "
252056|NCT00252525|"~     CSP 465-B, Correlation of Plasma Endothelial Cell (Basic Fibroblast Growth Factor) Activity~     With Cardiovascular Events in Patients with Diabetes Mellitus, Type II.~      Mark Zimering M.D.~      Objectives: Endothelial cell dysfunction plays a role in the development of the~     atherosclerotic vascular lesion and it is also thought to provide a mechanism for increased~     urinary albumin excretion in type 2 diabetes mellitus. Micro- or macroalbuminuria are~     associated with increased cardiovascular (CV) morbidity and mortality in type 2 diabetes~     mellitus. In at least one longitudinal study in older-age onset patients, micro-or~     macroalbuminuria robustly predicted increased CV risk independent of other diabetes-related~     factors.1 The pathogenetic mechanisms underlying a significant association between micro- or~     macroalbuminuria and CV risk in diabetes mellitus are not known but may include: growth~     factors, clotting factors, lipids, or hemodynamic factors. The aim of the present study is to~     investigate whether an angiogenic growth factor, basic fibroblast growth factor (bFGF), plays~     a role in increased CV risk in type 2 diabetes mellitus. Research Plan: BFGF (FGF-2) is one~     of the most potent known angiogenesis factors. Increased bFGF was previously associated with~     both endothelial cell injury and micro- or macroalbuminuria. In a prior study of 73 older-age~     onset veterans with type 2 diabetes mellitus (JCEM, 1996), we found plasma endothelial cell~     (bFGF) activity was significantly associated with glycemic levels, and (in multiple~     regression analysis) independently associated with both microalbuminuria and retinopathy. We~     will test whether plasma endothelial cell (bFGF) activity is significantly, independently~     associated with a pooled endpoint of cardiovascular events that includes myocardial~     infarction (MI), coronary revascularization, congestive heart failure (CHF), or CV mortality.~     We expect that increased bFGF may itself be a robust marker for increased CV risk in diabetes~     mellitus for three reasons. First, because bFGF was independently associated with~     (micro)-albuminuria in type 2 diabetes mellitus. Second, because increased bFGF was~     associated with increased activity in the renin-angiotensin system in vascular smooth muscle~     cells (Dzau, et al. JCI, 1995). And third, because (as we reported) angiotensin converting~     enzyme inhibitor (ACEi) drugs substantially decreased plasma bFGF levels in (micro)-~     albuminuric diabetes mellitus type 2, and (as others reported) ACEi drugs substantially~     reduced the risk of development of CHF in patients with LVH 2, the risk of mortality after MI~     (8,9), and the risk of CV death in diabetic patients with proteinuria.~      Because plasma endothelial cell (bFGF) activity correlated significantly with glycemic levels~     in diabetes mellitus type 2, plasma bFGF may be one of the pathogenetic links between~     glycemic levels and an increased risk of cardiovascular events in diabetes mellitus, type 2.~      Methods: Blood (3 mL EDTA plasma) will be collected from each subject in Years 1, and 2 of~     the Study at each of 6 local participating VA substudy sites. Because plasma endothelial cell~     (bFGF-like) bioactivity and bFGFR-IR in vivo are stable for months and years based on our~     prior published studies (1-3), we anticipate that obtaining 2 specimens, 1 each in Years 1, 2~     of the study, will provide sufficient data to model proportional risk.~   "
252057|NCT00252512|"~     Contingency management interventions involve providing a tangible reward for progress toward~     treatment goals. The purpose of this study is to determine whether a contingency management~     intervention added to usual care leads to improved attendance and decreased substance use in~     patients attending outpatient substance use disorders treatment.~   "
252058|NCT00252499|"~     The purpose of this study is to determine whether nonalcoholic fatty liver disease (NAFLD) is~     associated with altered peripheral and hepatic insulin sensitivity and to investigate~     potential mechanisms underlying insulin resistance in NAFLD by determining associations~     between hepatic and peripheral insulin sensitivity, hepatic steatosis, dyslipidemia,~     inflammatory cytokines, glucose metabolism, beta-cell function and body fat distribution.~   "
252059|NCT00252486|"~     The purpose of this study is to test the hypothesis that flax oil, as an omega-3 fatty acid,~     will be superior to placebo in the maintenance treatment of bipolar disorder in children and~     adolescents.~      Our primary objective was to determine if flax oil is efficacious in the pediatric bipolar~     population for reducing symptoms of mania and depression. A secondary objective was to~     examine fatty acid levels as predictors of treatment response and symptom severity. This~     clinical trial evaluated whether supplementation with flax oil, containing the omega-3 fatty~     acid alpha-linolenic acid (alpha-LNA), safely reduced symptom severity in youth with bipolar~     disorder.~   "
252060|NCT00252473|"~     Immobilization devices such as thermoplastic masks are used routinely in the radiation~     treatment of head and neck cancer patients. It is important to assess how well they function~     at preventing patient motion while the radiation treatment is being delivered. (i.e.~     isocentre set-up margins, patient motion with the mask). If these new thermoplastic masks~     such as MedTec S-frame allow less movement, then smaller margins are needed during radiation~     therapy which, in turn, would decrease side effects from the treatment.~   "
252073|NCT00252304|"~     The aim of this study is to assess whether zinc given as adjuvant therapy to standard~     antibiotic treatment in children hospitalized for severe pneumonia reduces the duration of~     the severe illness and risk of treatment failure. A randomized double blind placebo~     controlled clinical trial will be conducted at the Kanti Hospital.~   "
252654|NCT00244543|"~     The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution~     compared with placebo in alleviating the signs and symptoms of conjunctival allergen~     challenge-induced allergic conjunctivitis~   "
252061|NCT00252460|"~     The target volume in prostate cancer radiotherapy typically consists of the entire prostate~     gland which is localized by contours drawn on axial computed tomography (CT) radiation~     planning images. Compared with CT, magnetic resonance (MR) can provide better definition of~     the prostate gland with respect to the surrounding tissues and the use of multi-plannar~     reconstruction avoids the problem of partial volume averaging inherent in CT. CT has been~     shown to significantly overestimate the volume of the gland using the MR-defined prostate~     volume as the gold standard. Co-registration of MR and CT datasets, matched on fixed bony~     landmarks, has enabled radiation planning using a MR-defined clinical target volumes,~     combined with CT-based electron density information necessary for radiation treatment~     planning.~      Rationale and Hypothesis:~      Co-registration may allow better delineation of tumour volumes in prostate cancer. This~     investigation is a fesibility study designed to evaluate and optimize imaging parameters and~     co-registration techniques for CT planning and MRI Simulator.~   "
252062|NCT00252447|"~     Radical prostatectomy and radical radiation therapy remain the standard treatment approaches~     for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most~     effective when the disease is organ confined at the time of surgery. However, in many series~     up to 60% of patients have positive resection margins at the time of surgery and there is~     evidence to suggest that these patients may not be curable by surgery alone. A number of~     preoperative clinical variables including clinical stage, serum Prostate Specific Antigen~     (PSA) and Gleason scorea re helpful in determining the probability of finding organ confined~     disease at the time of syrgery.~   "
252063|NCT00252434|"~     The purpose of this study is to evaluate whether a specially developed group counseling~     approach is better able to help HIV-positive gay and bisexual men (GBM) who use crystal meth~     to stop using methamphetamines, reduce sexual risk behaviors, and stay on their HIV~     medications than a standard drug treatment program. Another purpose is to determine whether~     having a drug abuse treatment program in an HIV medical clinic makes it easier to attend~     treatment than going to a separate location for drug abuse treatment.~   "
252064|NCT00252421|"~     Osteoporosis or thinning of the bones affects in 1 in 4 Canadian women and 1 in 8 Canadian~     men. Moreover, while the rates of osteoporosis among Canadians are stabilizing, worldwide the~     number of people afflicted with osteoporosis continues to rise. The most serious complication~     of osteoporosis is a broken bone or fracture. Fractures due to osteoporosis can result in~     long hospital stays, dependence on others, and premature death. While there are several~     medications that prevent osteoporosis they all have side effects. For example, postmenopausal~     women who take hormone replacement therapy (HRT) are at increased risk of breast cancer and~     heart disease. In addition, drugs to prevent osteoporosis are expensive and not available~     worldwide. Therefore, it is essential that researchers continue to identify and test new~     medications for the prevention of osteoporosis.~      The purpose of the research is to determine if nitrates, a group of drugs that are widely~     available, inexpensive, and commonly used to treat chest pain or angina, can prevent~     osteoporosis in women. If the researchers find that nitrates prevent osteoporosis, a widely~     available, inexpensive treatment for osteoporosis prevention that does not have any long term~     side effects would have been identified. This will improve the health of patients with~     osteoporosis worldwide.~   "
252065|NCT00252408|"~     Hypothesis: Use of hormone replacement therapy (HRT) decreases the incidence of fractures in~     early postmenopausal women.~      The project was initiated in 1990, and the inclusion ended in 1993. A total of 2,016 early~     postmenopausal women were divided into two groups: The first group accepted randomisation to~     HRT or not, and the second group was allowed to choose HRT or not.~      The study was not blinded. Main measurements were fracture risk over 20 years, changes in~     bone mineral density over 20 years, and side effects, mainly breast cancer.~   "
252066|NCT00252395|"~     All reliably evaluated POE systems to date have been desktop computer based, but now there is~     widespread use and acceptance among physicians of PDA devices for a variety of purposes.~     Clinicians report that drug information on a PDA improved their access to information and~     efficiency while reducing their self perceived error rates6. The use of these devices for~     information retrieval in clinical settings is expected to grow as wireless communication~     becomes more ubiquitous and as more applications become available6,7. During the past decade~     there has been a growing awareness of several issues aimed at promoting safer health care for~     our patients – point of care information technology is one of the keys.~      To this end we have worked with a Canadian company, Drugmagnet, to develop and implement~     PDA-based electronic prescribing system within a major Canadian academic health centre. This~     is a cluster randomised trial, in which access to and use of the e-prescribing system is~     switched on and off for randomly chosen weeks, thus time serves as the randomized element.~   "
252067|NCT00252382|"~     The purpose of this study is to evaluate the objective tumor response rate (based on the~     RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.~   "
252068|NCT00252369|"~     This study is aimed to assess the hypothesis that instillation of fibrin glue with the~     induction of local conditions using Infliximab, may be useful in the treatment of perianal~     Crohn's disease.~   "
252069|NCT00252356|"~     To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in~     patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive~     control. The study is a multicenter, US and Canadian, randomized, double-blind,~     3-parallel-group, placebo- and escitalopram-controlled, Phase III study consisting of four~     segments (A, B, C and D). Segment A is a 1-week, placebo, single-blind period. Segment B is~     an 8-week, double-blind period. Segment C is an optional 18-week double-blind extension~     period. Segment D is a 1-week safety follow-up period after study drug discontinuation or~     early termination (during Segment B or C).~   "
252070|NCT00252343|"~     To evaluate the efficacy of a fixed dose of SR58611A (350mg q12) compared to placebo in~     patients with GeneralizedAnxiety Disorder (GAD) using escitalopram (10 mg qd) as positive~     control. To evaluate the tolerability and safety of SR58611A in patients with GAD.~   "
252071|NCT00252330|"~     To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in~     patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive~     control. In addition, the tolerability and safety of SR58611A in patients with MDD will be~     evaluated.~   "
252074|NCT00252291|"~     This is a Phase 3 study to determine the sensitivity and specificity of the Aridol bronchial~     challenge test to detect bronchial hyperresponsiveness in patients with suspected asthma.~     Patients with suspected asthma of either gender, aged between 6 and 50 years, with only~     mildly impaired lung function (FEV1 >70%) are to be tested with three different bronchial~     hyperresponsiveness challenges (Aridol, exercise and methacholine), and the results compared.~     A clinical diagnosis will also be made at the end of the study.~   "
252075|NCT00252278|"~     Children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) very commonly~     experience difficulty in initiating and maintaining sleep. Studies have shown that daytime~     sleepiness resulting from insufficient sleep can affect attention and learning. Therefore,~     treating insomnia in children with ADHD may not only improve sleep, but it could potentially~     improve ADHD symptoms as well.~      The main purpose of this study is to examine the effects of atomoxetine on ADHD-related~     insomnia. Atomoxetine (Strattera®) is a non-stimulant drug used to treat ADHD symptoms in~     both children and adults, and there is evidence that it may also have a positive effect on~     sleep in children with ADHD. During the study, participants will receive either atomoxetine~     or placebo for a period of four weeks. We expect that the effects of atomoxetine on sleep~     will differ from those of placebo, with atomoxetine having a greater effect on improving~     sleep difficulties.~   "
252076|NCT00252252|"~     The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP~     non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing~     during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory~     disorders (eg. neuromuscular disease or chest wall disorder).~   "
252077|NCT00252239|"~     The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is~     better for treating stroke patients and if TNK offers an advantage over currently available~     treatment with tissue plasminogen activator (tPA).~   "
252078|NCT00252226|"~     This is a single center, open prospective study to evaluate the effectiveness of quetiapine~     monotherapy in the maintenance treatment of adolescent patients with a bipolar spectrum~     disorder (bipolar I and bipolar II disorders, cyclothymia, and bipolar disorder not otherwise~     specified [bipolar NOS]) for a minimum of 48 weeks. Patients will be screened (enrolment~     phase) either when already stabilized or during an acute episode of mania/hypomania or~     depression.~   "
252079|NCT00252213|"~     This study is being done to determine the effects (good and bad) of intravenous infusion of a~     human brain natriuretic peptide (BNP), Natrecor (nesiritide), a hormone produced by the heart~     in persons who have just suffered a heart attack. The human BNP, Natrecor (nesiritide) has~     been approved by the United States Food and Drug Administration (FDA) to be given~     intravenously for the management of acute heart failure. It is unknown if human BNP may have~     good effects on the pumping function of the heart after a heart attack.~   "
252080|NCT00252200|"~     Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing~     heart bypass surgery.~   "
252081|NCT00252187|"~     The purpose of this study is to determine the effects of subcutaneous injection of Human BNP~     (nesiritide), a hormone produced by the heart, on the pumping ability of the heart, kidney~     function, and hormonal function in persons with heart failure.~   "
252082|NCT00252174|"~     This is a pilot study intended to find out if 3,4-methylenedioxymethamphetamine (MDMA) is~     safe and can help people with advanced stage cancer and anxiety arising from the cancer~     diagnosis.~   "
252083|NCT00252161|"~     The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant~     chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and~     large type 3 tumor in comparison with surgery alone.~   "
252084|NCT00252148|"~     The purpose of this study is to determine the safety of an immune response to an~     investigational HIV vaccine, ADMVA, at three different dosage levels, in adults who are not~     infected with HIV~   "
252085|NCT00252135|"~     This study is a multicenter, prospective, observational cohort study of ~5000 Xolair-treated~     and ~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a~     positive skin test or in vitro reactivity to an aeroallergen.~   "
252086|NCT00252122|"~     The purpose of this pilot study is to provide a preliminary assessment of the feasibility and~     efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease~     (who are admitted to the hospital with severe, acute pain crisis, and who have been resistant~     to intravenous narcotics).~   "
252087|NCT00252109|"~     Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT) is a supplement to~     the Centers for Disease Control and Prevention (CDC) Community Based Organization Program~     Announcement 04064 (PA 04064). The purpose of ADAPT is to improve the understanding of the~     processes needed for adapting evidence-based behavioral interventions to fit new conditions~     or populations and to pilot the CDC-developed adaptation guidance. The ADAPT project responds~     to concerns from the field that existing interventions do not address the HIV prevention~     needs of their specific population. This project seeks to develop guidance for agencies to~     engage in the evidence-based adaptation of interventions previously shown to be effective in~     evaluation settings for use in real world applications.~      The New Orleans AIDS Task Force (NO/AIDS) is one of five grantees funded to use the~     adaptation guidance to adapt an intervention packaged by the CDC's Replicating Effective~     Programs and disseminated by CDC's Diffusion of Effective Behavioral Interventions. The~     agency will adapt Jeff Kelly's Popular Opinion Leader (POL) intervention (Kelly, 2004; Kelly~     et al., 1991) for use in Internet venues with seropositive men who identify~     ethnically/racially as other than White/Caucasian who have sex with other men (men who have~     sex with men [MSM] of color).~      Kelly's POL intervention is a community-level, evidence-based HIV prevention intervention~     that originally targeted gay and bisexual men in smaller cities throughout the United States.~     Kelly's intervention seeks to identify and enlist the support of well-known and well-liked~     opinion leaders to take on risk reduction advocacy roles. Opinion leaders attend sessions to~     learn how to engage in risk reduction conversations with people in their own social networks.~     The opinion leaders help to reshape social norms to encourage safer sex by helping to create~     a social environment in which MSM feel comfortable and empowered to make decisions to avoid~     high-risk sexual behaviors.~   "
252088|NCT00252096|"~     Investigators at the University of Alabama in Birmingham in collaboration with investigators~     from the Centers for Disease Control in Atlanta are evaluating the performance of three~     commercial nucleic acid amplification tests for the detection of Chlamydia trachomatis and~     Neisseria gonorrhoeae in pharyngeal and rectal swab specimens. Cultures for C. trachomatis~     and N. gonorrhoeae are performed as additional reference tests. Study subjects are men and~     women attending sexually transmitted disease (STD) and HIV care clinics in Birmingham,~     Alabama, who report sexual behaviors that place them at risk for pharyngeal or rectal~     sexually transmitted infections.~   "
252107|NCT00251849|"~     The objective of this study is to determine whether rifalazil can significantly increase peak~     walking time (PWT) in patients with peripheral arterial disease (PAD).~   "
252089|NCT00252083|"~     This study will look at the following questions:~        -  Was there a significant difference in HIV prevention knowledge, risk reduction~          attitudes, norms, intentions, self efficacy, number of sexual partners, and incidence of~          unprotected anal intercourse among seropositive Hispanic men who have sex with men (MSM)~          after the implementation of ADAPT-POL?~      Hypothesis: There will be a significant increase in HIV prevention knowledge, intentions, and~     self efficacy concerning condom use. There will be a decrease in risk attitudes, norms,~     number of sexual partners, and incidence of unprotected anal intercourse among seropositive~     Hispanic MSM after the implementation of ADAPT-POL.~        -  How is exposure to the intervention and intervention dosage related to the following~          variables: HIV prevention knowledge, attitudes, intentions, and behaviors concerning~          unprotected anal intercourse?~      Hypothesis: Intervention exposure and dosage are positively correlated with improved HIV~     prevention knowledge, attitudes, intentions, and behaviors concerning unprotected anal~     intercourse.~   "
252090|NCT00252070|"~     The purpose of this study is to develop and evaluate a progressive, land-based exercise~     program, that includes muscular and aerobic conditioning, resistance and stabilization~     exercises and balance training, for persons with arthritis.~   "
252091|NCT00252057|"~     The purpose of this study is to determine if the Re-Engineered Discharge will decrease~     rehospitalization rates and adverse events of patients leaving Boston Medical Center.~   "
252092|NCT00252044|"~     Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1)~     working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the~     AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis~     by drug administration of 0.3 mg of oral pergolide interaction for performance on the~     cognitive tasks, with the schizotypal personality disorder group demonstrating significantly~     improved peformance compared to the other personality disorder group after pergolide compared~     with placebo.~      Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects~     receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed~     by pergolide for four weeks.~   "
252093|NCT00252031|"~     Subjects will receive a 6-month course of DBT, consisting of one 90-minute group and one~     60-minute individual session per week as well as telephone availability of the individual~     therapist.~   "
252094|NCT00252018|"~     The purpose of this study is to investigate whether a daily intake of dried broccoli sprouts~     will improve the endothelial function of the participants as measured by Flow mediated~     dilation (FMD)~      The dried sprouts are chosen because broccoli sprouts are known as containing large amounts~     af the glucosinolate glucoraphanin which in vitro and in animal models has been shown to have~     a positive effect on the endothelium as measured by NO release.~   "
252095|NCT00252005|"~     The purpose of this clinical research study is to assess efficacy and safety of 3 doses of~     apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional~     treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the~     treatment of subjects with acute symptomatic deep-vein thrombosis.~   "
252096|NCT00251992|"~     The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during~     an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms~     resolution at the end of a subsequent treatment period of 7 weeks.~   "
252097|NCT00251979|"~     This study is being carried out to see if constant 3 days infusion of Nexium is effective in~     preventing rebleeding after an endoscopic treatment.~   "
252098|NCT00251966|"~     The purpose of the study is to evaluate the effect of esomeprazole 20 mg od versus placebo~     for the prevention of gastric and/or duodenal ulcers in patients taking low-dose ASA.~   "
252099|NCT00251953|"~     This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled~     study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with~     type 2 diabetes, not adequately controlled on optimized metformin treatment and on~     diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week~     enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in~     period, followed by a 24-week double blind treatment period and a 3-week follow-up period~   "
252100|NCT00251940|"~     This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled~     study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients~     with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on~     diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week~     enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in~     period, followed by a 24-week double blind treatment period and a 3-week follow-up period~   "
252101|NCT00251927|"~     The study investigates the efficacy of long-term treatment of esomeprazole compared to~     anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to~     treatment failure.~   "
252102|NCT00251914|"~     The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during~     an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms~     resolution at the end of a subsequent treatment period of 7 weeks.~   "
252103|NCT00251901|"~     The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of~     acid related pain or discomfort in the chest.~   "
252104|NCT00251888|"~     Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic~     radiotherapy in patients with an advanced cervix cancer.~   "
252105|NCT00251875|"~     The study uses a randomized, prospective cohort design to assess the impact of shared online~     health records on 1) patient safety, 2) health goal adherence and outcomes, 3) documentation~     of family history, and 4) barriers to the adoption of patient-physician communication~     technology.~      Hypothesis: the respective interventions will result in 1) improved patient safety 2) greater~     adherence to health care maintenance and chronic disease guidelines 3) more accurate~     documentation of family history 4) the identification of technology adoption enablers and~     barriers.~   "
252106|NCT00251862|"~     The overall objective of this study is to conduct a three-arm randomized controlled trial to~     evaluate the impact of an interactive, web-based decision aid on shared decision-making and~     patient adherence to colorectal cancer (CRC) screening recommendations.~   "
252108|NCT00251836|"~     The success of kidney transplantation is hampered by the shortage of organs. One attractive~     strategy is the use of kidneys from living donors. During the donor operation the kidney~     artery, kidney vein and ureter have to be interrupted as far as possible from the kidney to~     have sufficient length for the reconnection of these structures in the transplant operation.~      An adrenal gland is situated at the upper pole of each kidney. While the arterial supply is~     accomplished by many small vessels, the venous drainage is only through one vein. On the~     right side the adrenal vein empties directly into the inferior vena cava (the large vessel~     transporting blood from the lower body to the heart). In contrast, on the left side the~     adrenal vein empties into the kidney vein, which in turn drains to the inferior vana cava.~     Due to these anatomical differences a left-sided removal of a kidney always necessitates an~     interruption of the left adrenal vein, while a right-sided kidney removal does not.~      As the venous drainage of the left adrenal gland is closed during living kidney donation, the~     gland is most likely functionally impaired. This can be compared to a right-sided kidney~     donation, where the adrenal vein is left intact. These comparisons are performed by adrenal~     function tests before, one week after and one month after kidney donation. These function~     tests consist of blood values drawn after stimulation with a hormone drug.~   "
252109|NCT00251823|"~     Rationale:~      ST-elevation myocardial infarction (STEMI) is usually triggered by rupture of an~     atherosclerotic plaque that then accumulates platelets and fibrin and leads to an occlusive~     coronary thrombus. Clinical benefits obtained with revascularization of the infarct related~     artery (IRA) depend on the achievement of four goals:~        1. Early reperfusion~        2. Full restoration of normal flow in the epicardial vessels~        3. Full restoration of flow in the microcirculation, and~        4. Preservation of myocardial function.~      Reperfusion of the IRA can be achieved pharmacologically with intravenous thrombolytic~     agents, or mechanically with percutaneous coronary intervention (PCI). In Canada,~     thrombolysis is the current standard of care in most hospitals, although there is mounting~     evidence that primary PCI is superior, and many Canadian centres are shifting towards this~     strategy. To offer primary PCI to community hospitals without on site cardiac catheterization~     facilities, regional programs need to be present that allow rapid transfer to invasive~     centers that offer this procedure round-the-clock.~      Recent evidence suggests that angiographic and clinical results with primary PCI could be~     further enhanced by facilitation with a pharmacological treatment given prior to the~     procedure. The present proposal plans to examine the safety and efficacy of eptifibatide to~     facilitate coronary angioplasty in STEMI in patients who present to centres with and without~     on-site catheterization facilities.~      The primary outcome measure will be a composite clinical endpoint including death, recurrent~     myocardial infarction, recurrent unstable ischemia, or stroke, at 30 days.~      Secondary endpoints include the percent thrombolysis in myocardial infarction (TIMI) grade 3~     coronary flow after the PCI, myocardial perfusion score, individual clinical outcomes as~     listed for the primary endpoint, resolution of ST-segment elevation, requirement for~     subsequent revascularization, frequency of congestive heart failure (CHF), cardiogenic shock,~     and Canadian Cardiovascular Society (CCS) angina class.~   "
252110|NCT00251810|"~     This study aims to test whether two depth-of-anaesthesia-monitors can perform equally well in~     monitoring anaesthetic sleep, both at induction and emergence from anaesthesia and during~     surgery.~   "
252111|NCT00251797|"~     The study will try to answer these questions:~        1. What is the highest dose of thalidomide brain cancer patients can receive safely in~          combination with irinotecan?~        2. How well does this combination work to shrink brain tumors, and how long do responses to~          treatment last?~        3. What side effects does the combination of drugs cause?~        4. How does treatment affect patients' quality of life (how they feel and what activities~          they are able to do)?~   "
252112|NCT00251784|"~     Patients sometimes report subjective visual effects when taking sildenafil. Our study set out~     to measure these in a controlled setting. Subjects were asked to detect patterns presented on~     a monitor screen.~   "
252113|NCT00251771|"~     Deep vein thrombosis (DVT) is a severe disease, and conventional treatment with low molecular~     weight heparin (LMWH) and warfarin is associated with some degree of long-term sequelae, i.e.~     post-thrombotic syndrome (PTS). Catheter-directed thrombolytic (CDT) therapy has been~     introduced worldwide the last two decades. Reports have suggested a beneficial effect of this~     costly treatment, but there are no randomized clinical trials documenting its short- and~     long-term efficacy and safety. This multi-center study will randomize patients with acute~     iliofemoral vein thrombosis to either conventional treatment or CDT in addition to~     conventional treatment. Main outcome parameters are patency rates at 6 months and prevalence~     of PTS at 24 months. The main short-term hypothesis is that CDT of first-time acute DVT will~     increase patency of the affected segments after 6 months from <50% to >80%. The main~     long-term hypothesis is that CDT will improve long-term functional outcome, i.e. risk of PTS~     after 2 years from >25% to <10%.~   "
252114|NCT00251758|"~     The purpose of this study is to assess the efficacy and safety of daily treatment with~     Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD~     in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal~     reflux disease (GERD).~   "
252115|NCT00251745|"~     The purpose of this study is to assess the efficacy and safety of daily treatment with~     Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD~     in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal~     reflux disease (GERD).~   "
252116|NCT00251732|"~     The main objective of this study is to evaluate the role of pain modulation in GERD patients~     who fail to obtain clinical relief with standard dose (once daily) PPI. The study will~     compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to,~     2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom~     resolution and health related quality of life in GERD patients who fail standard dose PPI and~     are randomly assigned to one of these three groups.~   "
252117|NCT00251719|"~     This is a study to assess the efficacy and safety of 8 weeks of treatment with~     Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole~     (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.~   "
252118|NCT00251706|"~     Rapid heart rhythms originating from the upper heart chambers (atrial tachyarrhythmias) are~     very common after open-heart surgery. The hypothesis of the PAPABEAR study is that a brief~     (13 day) peri-operative course of oral amiodarone therapy would be effective and safe for the~     prevention of these post-operative atrial tachyarrhythmias.~   "
252119|NCT00251693|"~     The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD)~     treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in~     healing subjects with endoscopically proven erosive esophagitis.~   "
252120|NCT00251680|"~     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily~     (QD), taken with established lipid-lowering therapy in subjects with type 2 diabetes~     mellitus.~   "
252122|NCT00251641|"~     This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label~     study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the~     treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to~     severe plaque-type psoriasis for at least 6 months prior to screening (subjects with~     concurrent psoriatic arthritis may also be enrolled).~   "
252123|NCT00251628|"~     The purpose of this study is to determine whether around-the-clock dosing of pain medication,~     with or without nurse coaching, increases the effectiveness of pain management (i.e.,~     decreased pain intensity scores with and without swallowing, increased use of pain~     medication, improved sleep, increased oral intake of fluids, decreased negative behaviors,~     and the same degree of side effects), over time, compared to standard care with as needed~     dosing.~   "
252124|NCT00251615|"~     The purpose of this study is to learn what changes in blood vessel contraction may occur as a~     result of a disease of the vessel that requires surgery. The study will examine the calcium~     channels present in the vessels being operated on, and the genes that may alter blood vessel~     function. Possible variation in these genes may change the kind of calcium channels present~     in blood vessels.~   "
252125|NCT00251602|"~     The purpose of this study is to learn the effects of genetic make up on response to the drugs~     atropine and propranolol, to examine how changes in heart rate and blood pressure can be~     measured, and to test a new statistical analysis method.~   "
252126|NCT00251589|"~     The reason for this study will be to find the safest maximum tolerated dose of oral~     vorinostat in combination with erlotinib [Tarceva (TM)] that can be given to patients with~     lung cancer who have relapsed or failed other therapy for the disease. Once the safest~     maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial~     will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also~     be evaluated.~   "
252127|NCT00251576|"~     A-Phase: Evaluating patients with chest pain who are receiving approved drugs, to estimate~     the effectiveness of one type of blood thinner as compared to another type of blood thinner.~      Z-Phase: To evaluate early treatment of patients with long term chest pain (using an approved~     drug for 30 days, followed by an increased dose of the drug) as compared to patients (treated~     with diet and 4 months placebo followed by diet and approved drug) in patients who have~     experienced acute chest pain or heart attack.~   "
252128|NCT00251563|"~     Environmental and genetic factors may play a role in the progression of cancer. The goal of~     this project is to establish a series of cross-sectional / case-control studies to evaluate~     risk factors of cancer in China.~   "
252129|NCT00251550|"~     To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive~     patients with Malignant Pleural Mesothelioma.~   "
252130|NCT00251537|"~     This is a pilot study to assess the safety and antiretroviral activity of a naturally~     occuring substance known as Leukotriene B4(LTB4). The aim of the study is to determine the~     effect of LTB4 on viral load during a period of 6 weeks, 4 weeks of active treatment and 2~     additional weeks after the end of active treatment for safety follow-up. 40 patients in seven~     clinics in Canada will be randomized into three treatment arms, either of two doses of LTB4~     or placebo. Study drug is administered intravenously once daily. LTB4 can activate and~     stimulate various white blood cells and by the activation release natural substances in the~     body and this process is an important part of the body's defense against infections.~   "
252131|NCT00251524|"~     This is a Phase II, open-label, non-randomized study in patients with advanced non-squamous~     NSCLC.~      Each cycle will be 21 days. Patients will be evaluated every 2 cycles (~6 weeks) for response~     using RECIST criteria. Those patients achieving stable disease or better will continue~     therapy. Those patients experiencing progressive disease will be taken off study.~      Patients will receive 6 cycles of Eloxatin, Alimta, and Bevacizumab. After the 6 cycles,~     patients will receive Bevacizumab alone every 21 days until evidence of disease progression~     or unacceptable toxicity.~      Note: Once patient has completed the 6 cycles of Eloxatin, Alimta, and Bevacizumab and is~     receiving single-agent Bevacizumab, assessment of response will be performed every 3 cycles~     (~every 9 weeks) using RECIST criteria.~   "
252132|NCT00251511|"~     This is a Phase II, open-label, non-randomized study in patients with low, intermediate-1,~     intermediate-2, or high-risk MDS (defined by IPSS).~      Each cycle of treatment will be 6 weeks in length. Patients will be evaluated every 6 weeks~     for response. Patients will be treated for a minimum of 12 weeks even in the absence of~     response. Following 12 weeks of treatment, patients will continue to receive study treatment~     until disease progression or unacceptable toxicity.~   "
252133|NCT00251498|"~     The primary objective of this study is to determine the efficacy (response rate) of cetuximab~     when administered in combination with docetaxel and carboplatin for treatment of patients~     with advanced non-small cell lung cancer.~      The secondary objectives of this study are:~        -  to determine the time to progression and overall survival for patients with advanced~          NSCLC who are treated with the combination docetaxel, carboplatin , and cetuximab~        -  to determine the toxicity of the combination in patients with advanced NSCLC.~      Patients with stages IIIB (pleural or pericardial effusion) and IV NSCLC who have not~     received any prior chemotherapy will be eligible to participate in the trial. Other~     eligibility criteria include: ECOG PS 0-1, normal hepatic and renal function, age >18 years.~     Specific inclusion and exclusion criteria are detailed in Sections 4.2 and 4.3.~   "
252134|NCT00251485|"~     This is a Phase II, open label, non-randomized study in patients with histologically or~     pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or~     rectum who have not received prior chemotherapy for their metastatic disease.~      Primary Study Endpoint:~      To assess the response rate, progression-free survival, and overall safety profile of a~     modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with~     metastatic colorectal cancer.~      Secondary Study Endpoint(s):~      To assess overall survival of patients with metastatic colorectal cancer who receive~     first-line therapy with a modified FOLFOX 6 + cetuximab regimen.~   "
252135|NCT00251472|"~     This is a Phase II, open-label, non-randomized study in patients with locally advanced or~     metastatic breast cancer.~      Each cycle of treatment will be 4 weeks in length. Patients will be radiologically evaluated~     every 8 weeks for response. Patients will continue to receive study treatment until disease~     progression or unacceptable toxicity.~   "
252137|NCT00251446|"~     This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural~     effusion) and IV NSCLC who have been previously treated with a platinum-based doublet.~      Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320~     mg/m2 as a 20-minute IV infusion.~      Patients will continue to receive study treatment until disease progression or unacceptable~     toxicity.~      Patients will be evaluated every 2 cycles for response using RECIST criteria.~   "
252138|NCT00251433|"~     This is a two-part study (Phase I/Phase II). Part I is designed to find the optimal (best)~     doses of GW572016, docetaxel, and trastuzumab when given together, Part II is designed to~     evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all~     three drugs compared to patients receiving only docetaxel and trastuzumab.~   "
252139|NCT00251420|"~     Therapeutic writing about one's emotions has been described previously (J Pennebaker:~     Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare~     the effects (if any) of writing about the emotional versus the physical consequences of lung~     disease on anxiety, perceived quality of life, and perceived health status.~   "
252140|NCT00251407|"~     The purpose of this study is to find the highest dose of the combination of taxotere,~     cisplatin and CPT-11, that can be given without causing severe side effects. We also want to~     test the safety of this drug combination and see what effects (good and bad) it has on~     patients with advanced cancer for which there is no known curable treatment.~   "
252141|NCT00251394|"~     The main purpose of this study is to determine the effects (good and bad) and the safety of~     Dynavax's immunostimulatory phosphorothiolate oligodeoxyribonucleotide (1018 ISS) given in~     combination with Rituxan on patients with B-cell follicular non-Hodgkin's lymphoma. This~     research is being done because recurrent follicular non-Hodgkin's lymphoma is not curable~     with standard chemotherapy or antibody treatments. 1018 ISS is an experimental compound that~     consists of short pieces of DNA that stimulate the immune system. It is hoped that 1018 ISS~     may improve the ability of Rituxan to kill cancer cells.~   "
252142|NCT00251381|"~     The purpose of this study is to determine the 1-year rate of locoregional disease control in~     the experimental arm, using a control arm to avoid selection bias.~   "
252143|NCT00251368|"~     The purpose of this study is to evaluate the side effects of 9-Aminocamptothecin (9-AC) and~     to determine the best dose which should be used to treat leukemia.~   "
252144|NCT00251355|"~     The purpose of this study is to test a new treatment of pancreatic cancer that cannot be~     removed by surgery. This treatment is a Phase I dose escalation research study which will~     combine one drug at increasing doses with a fixed dose of a second drug and radiation~     therapy. The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil~     will remain the same for all patients.~   "
252145|NCT00251342|"~     The objective of the present study is to evaluate the effectiveness of postnatal depression~     screening by comparing the mental health outcome (at 6 months postpartum) of mothers under~     the Edinburgh Postnatal Depression Scale (EPDS) screening programme versus usual clinical~     practice (usual practice), using randomized controlled trial design. With the use of the EPDS~     for the screening of postnatal depression, it is expected that more mothers in need of~     intervention (including mental health intervention, guidance in childcare and parenting,~     counseling in family relationships, etc) will be picked up and offered appropriate~     intervention, compared to the usual practice. It is hypothesized that the mental health of~     the group of women under the EPDS screening programme will be better than those under the~     usual practice, on subsequent follow-up.~   "
252146|NCT00251329|"~     The purpose of this study is to determine if this combination is safe and effective in this~     situation especially to increase the rate of pathological complete response (PCR). Women with~     large tumors and or lymph node involvement at the time of initial diagnosis may benefit from~     receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of~     tumor involvement before surgery. If chemotherapy given before breast surgery is effective in~     decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible.~     This new combination may be better tolerated than other commonly used regimens and, to date,~     appears to be at least as effective.~   "
252147|NCT00251316|"~     This study will examine the safety and effectiveness of using lithium, which has been used to~     enhance the effectiveness of high-dose 131I, with a single low dose (30 mCi) of 131I for~     thyroid ablation in patients with recently diagnosed papillary or follicular thyroid cancer~     who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid.~      Participants are randomly assigned to receive lithium capsules or placebo (look-alike~     capsules with no active ingredient). They follow a low-iodine diet for 2 weeks before~     starting treatment and are then admitted to the NIH Clinical Center for study and treatment~     for 11 days, during which they remain on the low-iodine diet. Blood samples are collected~     almost every day to analyze thyroid hormones, kidney and liver function, lithium~     concentrations and other tests.~   "
252148|NCT00251303|"~     This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive~     Disorder in Youth, Including those with Autism Spectrum Disorders.~   "
252161|NCT00251134|"~     Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The~     major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of~     recent trials hint that the course of CAD may be positively influenced by an increased intake~     of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an~     acute myocardial infarction. They are divided into two groups, both receiving standard~     post-infarction therapy. The subjects of one group additionally receive 1 gram of omega~     3-fatty acids daily for a time-period of 12 months, while the subjects in the second group~     receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported~     and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty~     acids.~   "
252162|NCT00251121|"~     Patients complaining of tachycardia but with a negative Holter ECG, are for a limited time~     period offered a simplified electrophysiological(EP) examination. By a full~     electrophysiological study(EP study)electrodes are introduced for pacing and sensing i all~     four heart chambers. Where as by the mini invasive EP study only one electrode is introduced~     to the right atrium. The simplified procedure represent a smaller risk of complications,~     requires less resources but should yield the same diagnoses in more than 90% of the cases.~     The study is a feasibility study to see if the procedure can discover arrythmias in a fairly~     unselected patient population.~   "
252149|NCT00251290|"~     Generalist physicians in the outpatient setting care for 80% of the 300,000 patients who have~     transient ischemic attacks (TIA) annually in the United States. Despite existing secondary~     prevention therapies, recurrent ischemic events are common following a TIA. Given the risk of~     poor outcomes and the important role of the generalist, new therapeutic approaches for~     patients with TIA are needed that can be applied by generalists to outpatients. This research~     will develop and evaluate a new therapeutic approach that centers on the observations that~     sleep-disordered breathing is a risk factor for cerebrovascular and cardiovascular disease,~     is common in patients with cerebrovascular disease, and is associated with poor outcome~     following a stroke or TIA. We posit that diagnosing and treating sleep-disordered breathing~     in the home of TIA patients can improve cerebrovascular and cardiovascular outcomes.~      The primary aims are to determine in TIA patients: 1) the prevalence of sleep-disordered~     breathing, 2) the feasibility of diagnosing and treating sleep-disordered breathing using an~     auto-titrating continuous positive airways pressure (auto-CPAP) machine within 24-hours of~     TIA symptom onset, 3) adherence to auto-CPAP, and 4) the effect of auto-CPAP on blood~     pressure.~      We will recruit 80 TIA patients to be randomly assigned to either the intervention or the~     control groups. Each patient in the intervention group will use an auto-CPAP machine for up~     to 90 days and will then receive an unattended sleep study using a sleep monitor. Each~     patient in the control group will receive two unattended sleep studies, one upon enrollment~     and another after 90 days.~   "
252150|NCT00251277|"~     The purpose is to evaluate safety and feasibility of the use of Rituximab as an adjunct to~     standard therapy (plasmapheresis + steroids) for patients with thrombotic thrombocytopenic~     purpura (TTP). This includes evaluating the rate and type of treatment failure.~   "
252151|NCT00251264|"~     The purpose of this study is to compare arthroscopic and open shoulder stabilization~     procedures by measuring the disease-specific quality of life outcome in patients with~     traumatic unidirectional anterior instability of the shoulder at 2 and 5 years.~      Hypothesis: There is no difference in disease-specific quality of life outcomes in patients~     with traumatic unidirectional anterior shoulder instability, undergoing an arthroscopic~     versus an open stabilization procedure.~   "
252152|NCT00251251|"~     Congestive heart failure (CHF) is a common health problem that leads to frequent~     hospitalizations and an increased death rate. In spite of advances in drug therapy, it~     remains a significant public health problem. Recently, a new therapy has been developed for~     advanced heart failure patients with a ventricular conduction abnormality. This new therapy,~     called cardiac resynchronization (CRT), is a device which stimulates the atrium, the right~     ventricle, and the left ventricle providing synchronization of the contraction of the heart~     chambers. It is the addition of this therapy to an implantable cardioverter defibrillator~     (ICD) that will be evaluated in this study. This study will compare whether the implantation~     of this new therapy device, in combination with an implantable cardioverter defibrillator,~     will reduce total mortality and hospitalizations for CHF.~   "
252153|NCT00251238|"~     The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with~     the primary Raynaud phenomenon, with regards to the frequency, duration and severity of~     vasospastic attacks.~   "
252154|NCT00251225|"~     The purpose of this study is to determine the effectiveness of two drugs, docetaxel and~     Gleevec®(also called imatinib), in prostate cancer that no longer responds to hormone~     therapy. The investigators are interested in finding out if the combination of these two~     drugs is more effective than docetaxel alone in the treatment of prostate cancer.~   "
252155|NCT00251212|"~     This study is designed to address both alcohol misuse and violence among adolescents ages~     14-18 seeking care in an urban emergency department (ED). The study is a randomized~     controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing~     and Skills Training intervention, delivered either by a computer or by a counselor, and an~     informational handout control condition.~   "
252156|NCT00251199|"~     VX-950 is an investigational drug , which is being tested in combination with a known~     treatment for hepatitis C, peginterferon.~   "
252157|NCT00251186|"~     This is a Phase II clinical trial measuring the effectiveness of the combination of~     Capecitabine and cetuximab for first line treatment of colorectal cancer in elderly patients~     and/or those with multiple comorbidities unable to receive standard chemotherapy. This study~     will be open approximately 2-3 years. Approximately 36 patients will be enrolled on this~     study. The study will begin enrolling at The Cancer Institute of New Jersey, with 17 patients~     in the first group. If more than 4 responses are noted, the accrual will continue to 36~     patients throughout CINJOG.~   "
252158|NCT00251173|"~     The proposed study will compare three alternative interventions in the emergency department~     (ED) to promote linkage to substance abuse assessment, referral and treatment entry for those~     who meet abuse/dependence criteria for stimulants, cannabis, and/or non-injected opioids: (1)~     a 5-session Strengths-Based Case Management (SBCM) model; (2) a 2-session Brief Motivational~     Enhancement (BME); or (3) a one-time Brief Informational Feedback (BIF) session. The primary~     outcome variables for this trial include receiving an assessment and referral and treatment~     entry. Other outcomes include degree of treatment completion, substance-related measures,~     health service utilization, health status changes, and psychosocial factors.~   "
252159|NCT00251160|"~     This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy~     (ETAC) to the current reference standard procedure, open inferior capsular shift (ICS), for~     the treatment of shoulder instability caused by ligamentous capsular redundancy.~     Multi-directional instability (MDI) and multi-directional laxity with anteroinferior~     instability (MDL-AII) are the two types of shoulder instabilities included in this trial.~      Hypothesis: There is no difference in disease-specific quality of life between patients~     undergoing an ETAC versus an open ICS for the treatment of shoulder instability caused by~     capsular ligamentous redundancy.~   "
252160|NCT00251147|"~     This study compares standard open rotator cuff repair versus arthroscopic mini-open rotator~     cuff repair by measuring the disease-specific quality of life at 2 years in patients with~     full thickness rotator cuff tears.~      Hypothesis: There is no difference in disease-specific quality of life outcome at two years~     between open versus arthroscopic mini-open repair for patients with full-thickness rotator~     cuff tears.~   "
252163|NCT00251108|"~     The aim of this project is to compare the efficacy of two different fitness exercise~     programmes on improving fitness and psychosocial functioning in a traumatic brain injured~     population. We hypothesize that a supervised fitness-centre based exercise programme,~     compared to an unsupervised home-based exercise programme will show significant improvements~     in cardiorespiratory fitness, depression and community integration.~   "
252164|NCT00251095|"~     The purpose of this study is to compare the objective response rates of patients randomized~     to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every~     week to patients with metastatic breast cancer. The study hypothesis is that the objective~     response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with~     Taxol given every week.~   "
252165|NCT00251082|"~     To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone~     versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months~     and to investigate the bleeding pattern over a treatment period of one year~   "
252166|NCT00251069|"~     Glucosamine sulphate causes no changes in blood levels of cholesterol~   "
252167|NCT00251056|"~     Many cystic fibrosis patients die of lung failure caused by repeated lung infections from~     thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the~     clearance of mucus by altering its rheology and replenishing the airway surface liquid layer~     in these patients, thereby enhancing the shift of stagnant mucus from the lungs. The study~     aim is to determine the optimal dose of mannitol to generate clinical improvement in patients~     with cystic fibrosis.~   "
252168|NCT00251043|"~     This study will evaluate the effectiveness of interpersonal psychotherapy in treating~     pregnant women with depression.~   "
252169|NCT00251030|"~     To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy~     subjects~   "
252170|NCT00251017|"~     Transporters in kidney are critical in detoxification and elimination of xenobiotics from~     systemic circulation, and thus are major determinants of drug response and sensitivity.~     Transporters in the renal epithelium control the exposure of renal cells to nephrotoxic drugs~     and environmental toxins and thus determine xenobiotic-induced nephrotoxicity. Organic anion~     transporters (OATs) and organic cation transporters (OCTs) are two major classes of secretory~     transporters in the mammalian kidney. Among the uptake transporters, OAT1, OAT3, or OCT2~     appear to be particularly important in the renal basolateral membrane to transport a large~     variety of endogenous and therapeutic compounds.~      Recently, rapid advances in single nucleotide polymorphisms (SNPs) mapping can now be applied~     to characterize the individual patients who suffer adverse effects to a drug, or those for~     whom a drug shows efficacy. The aim of this study was to identify and functionally~     characterize OCT2 variants as a first step towards understanding whether genetic variation in~     OCT2 may contribute to interindividual differences in renal elimination of vancomycin.~     Taiwanese patients will be screened and 12 coding region variants of OCT2 will be identified.~     The non-synonymous variants of OAT1, OAT3, or OCT2 will then be constructed and characterized~     using in vitro human renal cell models. It is to establish whether genetic variants in OAT1,~     OAT3, or OCT2 are likely significant contributors to intersubject variability in drug~     response. In addition, approaches toward prevention of some drug-induced nephrotoxicity are~     discussed, based on molecular mechanisms of renal accumulation of these drugs. Perhaps the~     researchers' understanding of OAT1, OAT3, or OCT2 in pharmacogenomics may contribute to the~     goal of individualized drug therapy. Development of new strategies based on the understanding~     of their cellular handing may achieve safer and more effective therapy for personalized~     medicines.~   "
252171|NCT00251004|"~     The purpose of this study was to compare the safety and efficacy of three immunosuppressive~     treatment regimens following a kidney transplant.~   "
252172|NCT00250991|"~     The purpose of this study is determine the effects of using of a combination of two~     drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator,~     rt-PA, or recombinant t-PA)--to dissolve blood clots in patients who have a stroke.~   "
252173|NCT00250978|"~     Your lung cancer has caused fluid to build up in the space around your lung. This fluid is~     called a malignant pleural effusion. This fluid takes up space in your chest, and prevents~     your lung from fully filling with air. As a result, you may be experiencing shortness of~     breath, cough, or chest discomfort. Your doctors have determined that you would feel better~     if a surgeon or pulmonary specialist removed this fluid immediately. Your doctors are~     offering to admit you to the hospital, and drain the fluid using a Pleur-XTM catheter.~      Once the Pleur-X catheter is in place, your doctors would like to start your chemotherapy.~      Your doctors have decided to treat you with chemotherapy. If the chemotherapy works to kill~     the cancer cells in your body, the cancer will make less fluid, and your doctors will be able~     to remove the Pleur-XTM catheter sooner.~      It is possible that adding a second drug to the chemotherapy, called bevacizumab may make he~     fluid dry up even faster. It is not known whether adding bevacizumab to chemotherapy for~     patients with a Pleur-XTM catheter in place is more helpful, or potentially more harmful,~     than using chemotherapy alone. For this reason, only patients enrolled in this research~     protocol can receive both chemotherapy and bevacizumab while they have a Pleur-XTM catheter~     in place.~      The purpose of this research study is to determine whether chemotherapy may be delivered~     safely with a Pleur-XTM catheter in place.~   "
252174|NCT00250965|"~     The objective of our research is to determine whether treatment with magnesium will reduce~     the incidence of atrial fibrillation in patients undergoing cardiac surgery. Several small~     studies of magnesium have already been conducted, but these studies were small and the~     results conflicting. A large, well-conducted study of magnesium treatment is required to~     definitively determine whether magnesium is effective in preventing this common complication~     after surgery. In addition, our study will include patients undergoing valvular surgery, a~     group previously excluded from research despite the fact that they are at increased risk of~     atrial fibrillation.~   "
252175|NCT00250952|"~     It is thought that the amount of fluid used to dilute Botox for injection has an effect on~     the quality of the result and the duration of effect on the treatment of upper face rhytides,~     even though the dose remains the same.~      The study was designed to test this thinking, using the crow's feet wrinkles as the treatment~     area.~   "
252176|NCT00250939|"~     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The overall objective is to evaluate the safety, pharmacokinetics (PK) and~     efficacy of Myozyme treatment.~   "
252177|NCT00250926|"~     The purpose of this study is to find out if the combination of bortezomib (Velcade),~     dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's~     macroglobulinemia.~   "
252178|NCT00250913|"~     Purpose: The purpose of this project is to determine how effective the telephone-based~     counseling program is at helping patients with heart disease become more physically active.~      Hypotheses to be tested:~        -  Compared to usual care, patients in the physical activity counseling program will:~             1. significantly increase total distance measured by an accelerometer and minutes of~               physical activity at a moderate intensity or higher,~             2. have significantly higher generic and heart-disease health-related quality of life,~               and~             3. will lead to greater improvements in the mediators of behavior change (psychosocial~               variables, i.e. self-efficacy, outcome expectations, etc.) at 26 and 52 weeks;~        -  Changes in the mediators of physical activity will predict changes in physical activity~          outcomes at 26 and 52 weeks;~        -  The physical activity counseling program is preferable to usual care from the~          perspective of health care system costs.~   "
252179|NCT00250900|"~     To determine if a wait and see prescription for ear infections in childhood reduces use of~     antibiotics compared to an immediate prescription~   "
252180|NCT00250887|"~     This study aims to determine effectiveness of Gefitinib (Iressa) in recurrent glioblastoma~     after standard treatment (surgery, radiationtherapy and at least a first line chemotherapy).~     Gefitinib is a specific inhibitor of the epidermal growth factor receptor (EGFR). EGFR is~     elevated in more than 50% of malignant gliomas. At recurrence, secondary surgery and pre- and~     postoperative Gefitinib is offered to patients in good performance status. Clinical outcome~     of patients and correlation to translational research will be evaluated.~   "
252181|NCT00250874|"~     To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate~     absence of negative interactions among the 3 drugs administered~   "
252182|NCT00250861|"~     The purpose of this research study is to find out if treatment with rituximab in combination~     with aldesleukin (compared to rituximab alone) decreases the risk of cancer returning, as~     well as determining what other effects (good and bad) this drug combination has on NHL.~     Rituximab and aldesleukin are not approved in combination by the Food and Drug Administration~     (FDA) for the treatment of non-Hodgkins lymphoma; however, Rituximab is approved for use by~     itself to treat NHL.~   "
252183|NCT00250848|"~     Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or~     evaluated for possible treatment of lung cancer at the Cancer Research and Treatment Center~     (CRTC) and New Mexico Veterans Health Care System (NMVHCS).~   "
252184|NCT00250835|"~     A combination of chemotherapy and radiation is often used to treat rectal cancer patients~     before surgery in an effort to shrink the tumor and make it easier to remove as well as to~     help increase the chances of sphincter-sparing surgery. Many previous clinical studies have~     suggested that rectal cancer patients may survive longer if the surgery results in a~     pathological complete response - that is, the absence of any tumor cells in the surgical~     specimen. However, there is still controversy over this. This study attempts to start to~     answer this question by treating rectal cancer patients with a combination of chemotherapy~     drugs (oxaliplatin and capecitabine), a cyclooxygenase-2 (COX-2) enzyme inhibitor and~     radiation before surgery. The rates of pathologic complete response, sphincter-sparing~     surgery, and disease-free survival are some of the therapeutic endpoints that will be~     studied.~   "
252185|NCT00250822|"~     To determine the primary end point response rate of the combinations of Gemcitabine and~     Oxaliplatin (Gem-Ox) in the treatment of hepatocellular carcinoma (HCC) in patients with~     platelet counts greater 100,000 per microliter in a single arme Phase II trial.~      To determine the toxicity profile of this regimen To determine the effect of this treatment~     on patient survival, time to treatment failure, time ot progression, time to response.~   "
252186|NCT00250809|"~     CVC Pros and Cons of scheduled Triple-lumen Central Venous Catheter Exchange: A Prospective~     Controlled Randomized Study~   "
252187|NCT00250796|"~     Primary Aim Determine the response rate and time to progression of the combination of~     thalidomide, interferon, and octreotide in patients with unresectable hepatocellular~     carcinoma (cancer of the liver that can't be treated surgically).~      Secondary Aims~        1. Determine the toxicity of this combination in this population.~        2. Determine the survival of this patient cohort treated with the combination.~        3. Determine the percent of patients with hepatocellular carcinoma who have a positive~          octreotide scan.~   "
252188|NCT00250783|"~     The purpose of this study is to provide a repository for long-term storage of endometrial~     cancer tumor and normal tissue, ascites and serum. This material will be used in studies to~     better understand the molecular biology of endometrial cancer.~   "
252189|NCT00250770|"~     The purposes of this study are the following:~        1. To further characterize and quantify both CSF-1 and colony-stimulating factor-1 receptor~          (CSF-1R) expression from additional tumor specimens, specifically, tumors of high grade~          and from metastatic sites.~        2. To assay using Enzyme-Linked ImmunoSorbent Assay (ELISA) sandwich monoclonal antibody~          methodology, CSF-1 expression in the peritoneal fluid and blood from patients with~          endometrial adenocarcinomas.~        3. Using immunohistochemistry, to evaluate the presence of staining for CSF-1 and CSF-1R~          from additional patients with endometrial adenocarcinomas, especially of high grades and~          from metastatic sites.~        4. To determine the extent of cytokine, specifically CSF-1, but also interleukin-1 (IL-1),~          IL-6, and granulocyte-macrophage colony-stimulating factor (GM-CSF), production, in~          endometrial carcinoma cells in primary cell culture.~        5. To determine the responsiveness of epithelial cells on estrogen and antiestrogen~          binding, to determine if CSF-1 production is mediated, in these cells, by estrogen~          receptor binding, or alternative pathways of intracellular/cell-cell signal~          transduction.~        6. The ultimate objective of these experiments is to characterize CSF-1 expression from~          benign and tumor cells in order to identify steps in the CSF-1 activated signalling~          pathways that may represent potential targets for therapy.~   "
252190|NCT00250757|"~     To develop the hypothesis that quantitative NMR spectroscopy of human semen can be used to~     diagnose prostate cancer.~   "
252221|NCT00250354|"~     The purpose of the study is to assess the safety and effectiveness of oral risperidone (an~     antipsychotic medication) in the treatment of conduct disorder and other disruptive behavior~     disorders in children ages 5 to 12 with mild, moderate, or borderline mental retardation.~   "
252222|NCT00250341|"~     This is a Phase 4, single center study conducted in mild-to moderate asthmatics.~   "
252191|NCT00250744|"~     1. To compare the effectiveness of gabapentin (titrated to300mg TID days -2 to 5) with~          aprepitant (125mg on day 1 and 80mg on days 2 and 3) in the control of delayed nausea~          and vomiting associated with level 3, 4 or 5 emetogenic chemotherapy in patients who~          experienced delayed nausea and/or vomiting during their first cycle of chemotherapy.~        2. To evaluate and compare the safety profile associated with each anti-emetic regimen.~        3. To assess subject satisfaction with anti-emetic therapy.~   "
252192|NCT00250731|"~     Research has shown that diabetes affects both the patient and family, and that support from~     family and partners helps diabetes patients manage their illness better. However, diabetes~     programs rarely involve the partner. This is a study to develop and test an intervention that~     helps partners and patients who have type 2 diabetes better support each other. The~     intervention will be delivered over the telephone to reach more people. Our hypothesis is~     that an intervention that targets the couple has a greater effect on health and well-being of~     patients than one that targets the individual patient alone.~   "
252193|NCT00250718|"~     1.1 To determine the efficacy of a combination treatment of VP-16, chlorambucil,~     dexamethasone, and vincristine in patients with relapsed/refractory hematological~     malignancies.~      1.2 To determine the toxicity profile of the above regimen in this patient population.~      1.3 Evaluate the effect of low dose administration of chemotherapy on angiogenesis, and~     correlate this with tumor responses.~   "
252194|NCT00250705|"~     The proposed study will be a 6-week open label study evaluating aripiprazole in the treatment~     of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct~     disorder. The initial dose depending on the weight of the patient will be as follows: < 25 kg~     = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003,~     Bristol-Myers Squibb). For the first two weeks of the study, the dose will be flexible based~     on response and tolerance and thereafter will remain fixed.~   "
252195|NCT00250692|"~     Our proposal is to study infants in the Neonatal Intensive Care Unit (NICU) who are~     undergoing a heel stick for blood sampling, a standard procedure in patient care. Currently,~     these infants do not get any pain relief for this procedure. Several recent clinical studies~     have shown the usefulness of nitrous oxide (laughing gas) for treating pain for minor~     procedures in children 0 to 18 years, but these effects have not been exclusively studied in~     the newborn and infant populations. Animal studies have questioned the anti-nociceptive~     (pain-blocking) effect of nitrous oxide in very young animals. It is unclear if this also~     applies to humans. The reason for this difference may be due to an immaturity of the neural~     pathways that modulate pain in the very young. The purpose of this study is to investigate~     whether or not nitrous oxide has an analgesic (pain-relieving) effect in infants undergoing~     minor procedures in the neonatal period (less than 3 months).~   "
252196|NCT00250679|"~     To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a~     period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).~   "
252197|NCT00250666|"~     The current study aims to validate the diagnostic use of PCT assessing its capability to~     individualize and shorten the duration of antibiotic therapy in critically ill patients with~     suspected or confirmed sepsis.~      In particular, no well-designed intervention study has properly examined the following~     hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic~     treatment duration in critically ill patients with suspected or documented sepsis, without~     harming patient safety.~   "
252198|NCT00250653|"~     The purpose of the study is to evaluate the long-term safety of saredutant (or SR48968C) in~     adult and elderly patients with depression.The primary objective is to evaluate the long-term~     safety and tolerability of a 100 mg dose of saredutant in adult and elderly patients with~     depression. The secondary objective is to evaluate blood levels of saredutant.~   "
252199|NCT00250640|"~     This is an observational study to monitor the continued effectiveness of Ventavis (inhaled~     iloprost) in the long-term. The study observes the effects and the safety of Ventavis~     inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from~     around 30 study sites in Europe will be included in the study. This observational study will~     collect information in patients receiving a medication that is already available on~     prescription in the participating countries. Ventavis is used to treat moderate cases of~     primary pulmonary hypertension.~   "
252200|NCT00250627|"~     The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)~     in patients with depression.~      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to~     placebo in patients with depression.~      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy~     of saredutant on disability and quality of life in patients with depression, and to evaluate~     blood levels of saredutant.~   "
252201|NCT00250614|"~     The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)~     in patients with depression.~      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to~     placebo in patients with depression.~      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy~     of saredutant on disability and quality of life in patients with depression, and to evaluate~     blood levels of saredutant.~   "
252202|NCT00250601|"~     The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)~     in patients with depression.~      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to~     placebo in patients with depression.~      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy~     of saredutant on disability and quality of life in patients with depression, and to evaluate~     blood levels of saredutant.~   "
252203|NCT00250588|"~     The purpose of this study is to determine whether Problem-Solving Skills Training is~     effective in reducing barriers to health care and improving health-related quality of life~     for children with persistent asthma.~   "
252204|NCT00250575|"~     Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of~     clozapine in patients with treatment-resistant schizophrenia.~      This study is not recruiting in the United States.~   "
252235|NCT00250172|"~     The purpose of this study is to measure a particular protein in the brain called the~     phosphodiesterase by using the imaging techniques of positron emission tomography (PET) and~     magnetic resonance imaging (MRI).~   "
252205|NCT00250562|"~     Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries~     worldwide for the treatment of hypertension. In China the usual recommended starting and~     maintenance dose is 80 mg o.d. The combination of HCTZ 12.5 mg with valsartan 80 mg has been~     shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in~     patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected~     patients6. This fixed combination is registered in most countries worldwide.~      The potential benefits of these combinations should be evaluated in patients not adequately~     controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and~     tolerability of adding HCTZ 12.5 mg to valsartan 80 mg in those hypertensive patients.~      This study is not recruiting in the US.~   "
252206|NCT00250549|"~     OraQuick is a safe, rapid test that accurately identifies HIV in as little as 20 minutes. By~     providing an accurate, quick method for detecting a person's serostatus and access to~     immediate post-test counseling, rapid testing has a crucial role in identifying HIV status~     and improving post-test counseling rates in populations who are at high risk of HIV infection~     and high failure to return rates. This prospective randomized control trial compared the~     educational effectiveness of a fifteen-minute post-test counseling video with the normal~     practice of a session with an HIV counselor.~   "
252207|NCT00250536|"~     This is a study to find out whether an exercise program during dialysis or a drug called~     nandrolone decanoate can increase muscle size and strenght in patients on dialysis.~   "
252208|NCT00250523|"~     The purpose of this research study is to gather clinical and biologic information from~     severely injured patients to better understand and characterize the host response to injury~     and inflammation across several domains. This information may improve outcome prediction,~     improve clinical treatment of injured patients, and permit the construction of non-biologic~     computerized models of illness that can be utilized to represent the host response in future~     research efforts. This study is designed as the calibration of a mathematical model of this~     response with predictive capabilities.~      The central hypothesis governing this study is that adaptive immune elements are crucial to~     determining the outcome of complex inflammatory scenarios. We propose to test these~     hypotheses in the following interrelated Specific Aims:~      Specific Aim 1: To develop a robust mathematical model describing trauma/hemorrhage-induced~     inflammation in humans, its pathologic consequences, and possible therapies.~      Specific Aim 2: To translate the mathematical model to humans and create software aimed at~     individualized clinical decision-making.~      Specific Aim 3: To determine the prevalence of an IL-1 receptor-associated kinase (IRAK-1)~     variant haplotype located on the X-chromosome in an injured population, and to characterize~     differences in the pro-inflammatory response across gender, relative to the IRAK-1 haplotype.~      Specific Aim 4: To determine if increased arginase activity previously observed in isolated~     peripheral blood mononuclear cells of trauma patients is a consequence of the presence of~     contaminating activated granulocytes or a particular subset of an arginase positive monocyte~     subset.~   "
252209|NCT00250510|"~     The purpose of this study is to simulate what would occur if insurance reimbursement became~     available for obesity treatment but required that the individual meet defined performance~     milestones.~   "
252210|NCT00250497|"~     The New Moves study will evaluate the impact of a school based program for inactive high~     school girls who are overweight or at risk for being overweight due to low levels of physical~     activity. The primary study hypothesis is that girls in the intervention schools will~     significantly decrease their percent body fat as compared to girls in the control schools.~     Secondary research hypotheses include that girls in the intervention condition will~     significantly increase their physical activity levels and improve the quality of their~     dietary intake.~   "
252211|NCT00250484|"~     The researchers aim to study the effects of repetitive transcranial magnetic stimulation~     (rTMS) on chronic visceral pain in patients with idiopathic chronic pancreatitis.~   "
252212|NCT00250471|"~     The primary purpose of this study was to compare the efficacy and safety of bivalirudin to~     eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high~     risk for heart attack and other cardiovascular complications who will undergo surgery to open~     up blocked arteries in the heart.~   "
252213|NCT00250458|"~     Study to test the effectiveness of a marketed drug in the treatment of migraine-associated~     nausea.~   "
252214|NCT00250445|"~     The study is designed to compare the risk of cardiovascular events (heart attacks, strokes)~     in patients receiving either etoricoxib or diclofenac. It will also compare the~     gastrointestinal tolerability of the two medicines. The study will be conducted in patients~     with either rheumatoid or osteo-arthritis.~   "
252215|NCT00250432|"~     Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3~     times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or~     systemic yeast infections)~   "
252216|NCT00250419|"~     To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as~     intramuscular injections followed by electrostimulation in cancer patients.~   "
252217|NCT00250406|"~     The purpose of this study is to determine the clinical effects of a triclosan stent on~     adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling~     triclosan ureteral stent. The patient populations that will be tested include: patients~     following ureteroscopy and patients scheduled to undergo shockwave lithotripsy who require a~     ureteral stent. It is hypothesized that triclosan eluting ureteral stents will reduce the~     number of bacteria both on (within biofilm) and around (in the urine) a ureteral stent.~   "
252218|NCT00250393|"~     To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified~     Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with~     Parkinson's disease (PD).~   "
252219|NCT00250380|"~     The purpose of this study is to determine the clinically meaningful definition and prevalence~     of aspirin resistance based on data linking aspirin-dependent laboratory tests to recurrent~     vascular events in cardiovascular patients taking aspirin.~   "
252220|NCT00250367|"~     The purpose of the study is to evaluate the effectiveness and safety of risperidone (an~     antipsychotic medication) versus placebo as add-on therapy to mood stabilizers, in the~     treatment of manic episodes associated with bipolar disorder.~   "
252223|NCT00250328|"~     The study involves adult subject requiring colonic anastomosis following laparoscopic~     intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC~     device instead of staplers.~      Endpoints: safety-Functioning secured anastomosis and no occurrence of adverse event related~     to device use.~      The efficacy endpoint of this study includes clinical evaluation of characteristic parameters~     related to intestinal surgeries.~      Discharge day (or ready-for-discharge) Proven anastomotic leak rate (clinically or~     radiological) Stenosis / stricture at anastomosis Patient recovery level will be assessed~     every day during hospitalization and in the follow up visits.~   "
252224|NCT00250315|"~     Patients with cirrhosis have a altered cardiac response to stress. This study evaluate the~     cardiac response by MRI during dobutamine stress. Hypothesis: impared increase in cardiac~     output, cardiac index, ejection fraction.~   "
252225|NCT00250302|"~     Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into~     different tissue types. The primary objective of the study is to examine the safety of using~     such cells to treat patients suffering from distal tibial shaft fractures. The cells will be~     isolated from the patient's bone marrow, loaded onto a carrier and implanted locally at the~     fracture site.~   "
252226|NCT00250289|"~     the use of a herbal formulation containing sage, echinacea,lavender and mastic gum would~     prevent oral malodor if delivered in an appropriate delivery system to enable slow release of~     the active ingredients.~   "
252227|NCT00250276|"~     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.~     Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can~     lead over time to cervical cancer in women . This study will compare the immune response~     induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the~     manufacturing process.~   "
252228|NCT00250263|"~     Allergic diseases represent a major health issue worldwide. Mainstay treatment is allergen~     avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the~     advantages of specific treatment with long lasting efficacy, and can modify the course of~     disease. However, use of this treatment is restricted by the high risk of adverse events~     especially in asthmatics. Other, better tolerated, routes of allergen administration than the~     current conventional subcutaneous route (SCIT) have been investigated including sublingual~     (SLIT). However, the immune parameters of SLIT have not been examined. We propose conducting~     a randomised, placebo-controlled study of a commercially-available SLIT for house dust mite~     (HDM) allergy to investigate induction of relevant T cell regulatory immune mechanisms. The~     first year will be followed by an optional open label extension period. Immunoregulatory~     cytokine synthesis and T cell phenotype and function (real time PCR and flow cytometry) will~     be examined. This project will provide important fundamental knowledge on which to base~     improved and greater application of this potentially curative treatment for allergy. SLIT has~     the potential advantage of home administration and suitability for patients with asthma who~     are currently unable to access many of the allergen desensitising regimens.~   "
252229|NCT00250250|"~     Children with growth failure due to inadequate secretion of growth hormone or growth~     retardation due to Turner's syndrome are individually dosed and treated for 12 weeks~   "
252230|NCT00250237|"~     In this study the investigators want to determine if treatment with haloperidol direct~     post-operatively after acute hip surgery in high risk patients protects against developing a~     post-operative delirium.~   "
252231|NCT00250224|"~     A new method for localization of the prostate during external beam radiotherapy. The method~     is based on insertion of a new thermo-expandable Ni-Ti stent. The radiological properties of~     the stent are used for precise prostate localization during treatment using electronic portal~     images~   "
252232|NCT00250211|"~     The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a~     tumor more accurately allowing a more targeted delivery of radiation. The investigators hope~     to learn whether tomotherapy will be able to deliver higher radiation doses safely to the~     tumor while sparing the surrounding normal tissue.~   "
252233|NCT00250198|"~     This study will test whether a new experimental drug called STA-5326 mesylate will decrease~     inflammatory chemicals called cytokines in patients with Crohn's disease. The drug has~     prevented gut inflammation in mice and rats and has improved symptoms in humans with active~     Crohn's disease.~      Patients with Crohn's Disease between 18 and 75 years of age and who have active disease~     symptoms may be eligible for this study. Candidates are screened with a review of their~     medical records, a medical history and physical examination, electrocardiogram, blood and~     urine tests, chest x-ray and tuberculin skin test. They fill out diary cards for 7 days~     (measuring their symptoms on the Crohn's Disease Activity Index, or CDAI) and complete a~     32-item Inflammatory Bowel Disease Questionnaire (IBDQ) that surveys how their disease~     affects their live and activities.~      Participants have a colonoscopy (an examination of the colon using a lighted tube) before~     starting the study medication. Colon tissue samples are biopsied during the procedure.~     Following the colonoscopy, patients are randomly assigned to receive either STA-5326 mesylate~     or placebo (sugar or dummy pill). They take four tablets a day and are seen in the clinic~     once a week (days 1, 8, 15, 22 and 29) for the following tests and procedures:~        -  Physical examination - Days 1, 8, 15, 22, 29~        -  Blood tests - Days 1, 8, 15, 22, 29~        -  Pharmacodynamic study (blood collected before the first dose of medicine and again after~          1, 2, 4, 6 and 8 hours to measure levels of the drug in the blood) - Day 1~        -  CDAI and IBDQ - Days 1, 15, 29~        -  Review of medications and symptoms - Days 1, 8, 15, 22, 29~        -  EKG - Days 8, 29~        -  Pregnancy test for women of child-bearing potential - Days 15, 29~        -  Urine test - Day 29~      After patients complete the above treatment and tests, they undergo a second colonoscopy~     within 48 hours of their last dose of study medication and may be offered another 1-week~     supply of medication. Those for whom additional treatment is deemed potentially beneficial~     are offered another 4-week course of drug or placebo (continuing whichever they took the~     first 4 weeks). They come to the clinic for two visits 2 weeks apart (days 43 and 57) for a~     physical examination, blood tests, EKG, pregnancy test for women, CDAI, IBDQ and review of~     medications and symptoms. A urine sample is collected only on day 57. A third colonoscopy is~     done after all the tests are completed on day 57, within 48 hours after the last dose of~     study medication.~      Patients return to the clinic about 1 week after their final dose of study medication (day 36~     for patients who complete only 1 month of treatment and day 64 for those who complete a~     second month of treatment) for a limited physical examination, blood tests, pregnancy test~     for women, CDAI and IBDQ, and a review of their medications and symptoms.~   "
252234|NCT00250185|"~     Many studies have shown that if the human body is stressed by a lack of blood flow for a~     short period of time, the body develops defenses to make the body more resistant to a future~     stress from lack of blood flow. This natural defense system is called preconditioning.~     Finding medications that have a preconditioning effect to protect against damage from loss of~     blood flow would be of great help in the treatment of diseases such as heart attacks and~     stroke that occur because of blockages of blood flow.~      Predicting future heart attacks or strokes is very difficult and makes it difficult to study~     medications that could have a preconditioning effect. However, it has recently been~     recognized that we can mimic the preconditioning effect in the human arm, by blocking blood~     flow using a blood pressure cuff under pressure. Here, blowing up the cuff for 5 minutes and~     then letting the pressure out for 5 minutes and repeating this process twice more (a way to~     precondition the arm), has been shown to improve blood vessel function in response to a~     longer period of blood pressure cuff inflation (20 minutes).~      As nitrite, a naturally occurring blood substance, has biological effects suggesting that it~     may mimic preconditioning. The main objective of this study is to assess whether nitrite is~     equivalent to preconditioning in its capacity to protect the forearm blood flow in response~     to a 20 minute blockage of blood flow by blood pressure cuff inflation of the forearm.~      We hypothesize that in human subjects the ischemic preconditioning program works through~     activation of the pool of nitrite in the blood stream. Moreover, we propose that nitrite~     treatment will improve (1) blood vessel recovery (2) skeletal muscle blood flow and (3)~     skeletal muscle mitochondrial function and (4) reduce the activation of inflammation in~     response to the 20 minute stress of blood pressure cuff inflation.~   "
252236|NCT00250159|"~     This study will evaluate and gather information in patients with genetic causes of too much~     androgen (male-like hormone) in order to better understand the effects of too much androgen~     and describe problems associated with it. Too much androgen in childhood, if untreated,~     results in rapid growth and early puberty with early cessation of growth and short stature in~     adulthood. Too much androgen in adulthood may result in infertility, and women may have~     excess facial hair, acne and a more male-like appearance. Excess androgen may also affect~     mood and behavior and possibly the secretion of other hormones, such as insulin. Two genetic~     diseases that result in early childhood androgen excess are congenital adrenal hyperplasia~     (CAH) and familial male-limited precocious puberty (FMPP).~      Patients with known or suspected CAH due to 21-hydroxylase deficiency, 11- hydroxylase~     deficiency, or 3-beta-hydroxysteroid dehydrogenase deficiency and males with known or~     suspected FMPP may be eligible for this study. Patients with both classic and non-classic CAH~     are eligible, and patients with androgen excess of unknown cause may be eligible.~      Participants undergo the following procedures:~        -  Medical history and physical examination.~        -  Fasting blood tests for analysis of hormones, blood chemistries including blood sugar~          and cardiovascular risk factors such as lipids.~        -  Oral glucose tolerance test for patients with elevated insulin levels. For this test, a~          catheter (plastic tube) is placed in a vein in the patient's arm. The patient drinks a~          sugar-containing fluid and blood samples are collected through the catheter at intervals~          starting with drinking the solution, and then 30, 60 and 120 minutes after drinking the~          solution.~        -  24-hour urine collection to measure hormone levels in the urine.~        -  DNA testing for patients with 21-hydroxylase deficiency to help identify the type of~          genetic mutation responsible for the disease.~        -  X-ray of the left hand to measure bone age in growing children. The x-ray is used to~          determine how far into puberty the child is and how much growth potential is left in the~          bones.~        -  A pelvic ultrasound in females and testicular ultrasound in males to evaluate the size~          and development of the gonads (ovaries in females and testes in males).~        -  Cognitive and psychological tests, including an IQ test and evaluation of memory,~          achievement and behavior.~        -  Other tests and evaluations based on medical need.~      The schedule for these procedures varies. In a part of the study involving only patients with~     CAH, growing children are evaluated twice (once in childhood and once after reaching adult~     height), and adults are evaluated once. In another part of the study involving patients with~     CAH and FMPP, growing children are seen twice a year, and adults and children who have~     reached adult height may be seen annually. Additional visits may be scheduled if medically~     indicated. In this part of the study, females are asked to keep a record of their periods~     after their first menstrual cycle.~   "
252237|NCT00250146|"~     The purpose of this study is to evaluate the toxicity of minute doses of gluten in the~     treatment of celiac disease, a disorder characterized by permanent intolerance to dietary~     gluten.~   "
252238|NCT00250133|"~     Selective decontamination of the digestive tract (SDD) is a prophylactic measure aimed at~     reducing Gram negative flora in the gut with an aim to reduce nosocomial infections such as~     ventilator-associated pneumonia. A recent large randomized trial in the Netherlands showed~     that SDD use was associated with reduced mortality in the ICU. Theoretically, SDD may select~     for Gram positive organisms such as MRSA or VRE. This was not observed in the Dutch study,~     but the rates of MRSA and VRE are very low in hospitals in the Netherlands. Fears of~     selection of MRSA and VRE have limited application of SDD in the United States.~      In this pilot study, 40 patients in the transplant intensive care unit (where SDD has been~     used intermittently for at least 10 years), will be randomized to SDD or no SDD. These~     patients will be known to be VRE positive at baseline. The effects of SDD on the density of~     VRE in the stool on day 7 compared to pre-SDD will be the primary endpoint. Secondary~     endpoints will be detection of MRSA and colistin resistant Pseudomonas in the stool.~   "
252239|NCT00250120|"~     To determine the overall response rate to liposomal 9-Nitro-20 (S)-Camptothecin (L9NC)~     administered by aerosolization in patients with non-small-cell lung cancer (any stage).~      To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days~     per week X 8 weeks, every 10 weeks.~      To perform a pharmacology study of L9NC in the plasma, and the lungs after aerosolization. A~     specific protocol will be written for this part.~   "
252240|NCT00250094|"~     1.1 To determine the regulation of topoisomerase I and II following alternating prolonged~     exposure to topotecan and etoposide (VP-16)~      1.2 To determine the time to progression and the objective response rate of this treatment in~     patients with incurable ovarian cancer.~   "
252241|NCT00250081|"~     Doctors use different treatments for people with Cerebral Palsy. Surgery is one option.~     Botulinum toxin injections are another option; these are given directly into spastic muscles~     to weaken them temporarily. Regular ongoing treatment (splinting, stretching and exercises)~     is another option. The investigators want to find out if surgery works better than Botulinum~     Toxin (Botox) injections or regular ongoing treatment (therapy), and if the effects of~     Botulinum Toxin injections last for longer than six months.~   "
252242|NCT00250068|"~     To determine the overall response rate to liposomal 9-Nitro-20 (S)-Camptothecin (L9NC)~     administered by aerosolization in patients with non-small-cell lung cancer (any stage.~      To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days~     per week X 8 weeks, every 10 weeks.~      To perform a pharmacology study of L9NC in the plasma, and the lungs after aerosolization. A~     specific protocol will be written for this part.~   "
252243|NCT00250055|"~     In general, to determine the sensitivity of light transport to tissue from morphological~     features of clinical significance.~      Determine how specific structural features contribute to light scattering. Investigate light~     scattering differences in tumorigenic and nontumorigenic cells.~      Develop and implement quantitative and sensitive methods for measuring morphological~     properties.~      Clinical measurements.~   "
252244|NCT00250042|"~     1.0 OBJECTIVES 1.1 To test the activity of arsenic trioxide in combination with imatinib in~     patients with CML with cytogenetic evidence of residual disease.~      1.2 To determine the toxicity associated with this therapy.~   "
252245|NCT00250029|"~     1.1 To collect pathological tumor specimens of patients with metastatic colorectal cancer in~     a prospective fashion for correlative studies of response to an oxaliplatin based~     chemotherapy regimen.~      1.2 To determine a gene expression profile that predicts response to an oxaliplatin based~     chemotherapy regimen in this cohort of patients.~   "
252246|NCT00250016|"~     The purpose of this study is to determine the amount of Aerosolized Liposomal-Nitro-20~     (S)-Camptothecin (L9NC) in a patients blood and tumor.~   "
252247|NCT00250003|"~     To investigate whether preventive home visits for healthy persons 75+, made by professional~     health workers, can change the pattern of care utilization and if the quality of life can~     improve. The hypothesis is that care utilisation will reduce, mortality decrease and quality~     of life improve.~   "
252248|NCT00249990|"~     The purposes of this study are:~      1.1 To determine the efficacy of liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by~     aerosolization to patients with metastatic endometrial cancer.~      1.2 To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive~     days per week X 8 weeks, every 10 weeks.~      1.3 To perform a pharmacology study of L9NC in the plasma and the lungs after aerosolization.~     A specific protocol will be written for this part.~   "
252276|NCT00249613|"~     The purpose of this study is to determine whether substance abuse treatment designed~     specifically for drug-dependent women offenders provides better outcomes than standard drug~     court treatment (mixed-gender programs).~   "
252249|NCT00249977|"~     1. To determine the safety and feasibility of administering Capecitabine with the~          combination of Cisplatin and Irinotecan.~        2. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the~          combination of Cisplatin and Irinotecan.~        3. To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin~          therapy.~   "
252250|NCT00249964|"~     The purpose of this study is to determine the maximum tolerable dose of temozolomide in~     combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor~     response rate with this combination and to determine the duration of response.~   "
252251|NCT00249951|"~     Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to~     birth weight and gestation age. Very low birth weight infants have the highest risk index,~     with ~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We,~     the researchers at the University of Cologne, and others found significantly decreased~     urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we~     hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's~     solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the~     incidence of nephrocalcinosis.~   "
252252|NCT00249938|"~     The purpose of this study is to see if combination therapy with a statin medication and two~     additional agents that work differently than statin medications can further lower the~     so-called bad cholesterol. One therapy is a prescription drug approved by the Food and Drug~     Administration to treat high cholesterol (Welchol). The other therapy is Minute Maid Heart~     Wise orange juice. This study juice is available in supermarkets and contains plant sterols~     that have been shown to lower cholesterol.~   "
252253|NCT00249925|"~     The specific aims of the study are to: 1) test the effectiveness of a home-bases intervention~     to improve home safety, fall efficacy and functional performance; 2) determine if the use of~     environmental strategies results in occurrence of less negative health events (falls and~     depression); 3) compare types of environmental strategies accepted and used under different~     treatment conditions; and 4) evaluate the cost-effectiveness of the intervention program.~   "
252254|NCT00249912|"~     The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or~     with rosuvastatin on cholesterol levels in treating patients with elevated cholesterol.~   "
252255|NCT00249899|"~     The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or~     with additional statin therapy on cholesterol levels in treating patients with elevated~     cholesterol.~   "
252256|NCT00249886|"~     The purpose of the study is to evaluate whether it is advantageous for adolescents who have~     recovered from depression after a 6 to 12 week course of antidepressant treatment to stay on~     the treatment a further 6 months or is it just as helpful to stop the medication after~     recovery.~      The hypothesis is that adolescents with major depression who recover from the 6 to 12 week~     trial of citalopram will be less likely to have a recurrence of depression over a 6 month~     period if continued on the citalopram as compared to those who discontinue the medication.~   "
252257|NCT00249873|"~     The purpose of this study is to determine if the combination of clopidogrel 75mg once daily~     (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily~     recommended dose) for preventing vascular events such as stroke and heart attack during~     approximately three years of follow-up in patients with atrial fibrillation associated with~     at least one major risk factor of vascular event such as elderly, blood pressure increase,~     history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study~     will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant~     therapy.~   "
252258|NCT00249860|"~     The main objective of this study is to establish interferon-beta-1a as the treatment of~     choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or~     combination therapy.~      This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo~     to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment~     during an open-label extension phase. The duration of the trial will be 48 weeks, with a~     double-blind period of 12 weeks.~      The study will recruit 257 eligible subjects of either sex. It will be conducted by~     approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and~     Singapore).~   "
252259|NCT00249847|"~     The purpose of this study is to determine in a preliminary manner whether successful therapy~     of hot flashes can be associated with changes in the serotonin transporter in the brain. The~     serotonin transporter is important in delivering serotonin into certain portions of the~     brains (serotonin is a chemical that is important in the control of body temperature, mood,~     sleep, and other functions).~   "
252260|NCT00249834|"~     Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which~     determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based~     on subject baseline characteristics/predictors of ovarian response.~   "
252261|NCT00249821|"~     Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1~     group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of~     Saizen® during 1 year to 1 group receiving 0.035 mg/kg/day (0.24 mg/kg/week) of Saizen®~     during 1 year after an initial 3-year treatment of recombinant human growth hormone (r-hGH)~     therapy with 0.057 mg/kg/day in both groups.~   "
252262|NCT00249808|"~     This is a Phase IIIb/IV, open label, multicentre study of efalizumab (anti cluster of~     differentiation [CD] 11a recombinant human monoclonal antibody) in participants with moderate~     to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are~     intolerant to other systemic therapies including ciclosporin, methotrexate, and psoralen and~     ultraviolet A phototherapy (PUVA).~   "
252263|NCT00249795|"~     The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the~     risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and~     death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular~     events.~   "
252300|NCT00249301|"~     The purpose of this study is to determine (1) The side effects or toxicities of MLN8054;(2)~     The highest dose where side effects or toxicities are not too severe; (3) How MLN8054 is~     absorbed into the general blood circulation and eliminated from the body; and (4) The levels~     of MLN8054 in the blood that are needed to inhibit Aurora A kinase.~   "
252264|NCT00249782|"~     The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared~     to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for~     the treatment of rosacea.~      ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United~     States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12~     years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An~     investigational use is one that is not approved by the FDA.~      Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed~     at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline~     and Week, 2, 4 and 12.~   "
252265|NCT00249769|"~     This study will determine whether it is safe and effective to administer Japanese~     encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If~     it is found to be safe, it will pave the way for use in routine vaccination programs. The~     hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles~     vaccine at the same time are protected against these diseases at the same level as those who~     receive the vaccines at different intervals.~   "
252266|NCT00249756|"~     The purpose of this study is to examine the transition of offenders with both mental illness~     and chemical abuse (MICA) disorders from prison to the community, where continued treatment~     is generally considered necessary to sustain gains made by prison treatment, and to achieve~     successful outcomes. The project will determine the effectiveness of a modified therapeutic~     community (Re-Entry MTC) approach as compared to the case management and parole supervision~     currently provided. The study will also assess the relative impact on treatment outcomes of~     the type of treatment received while in prison and of the progress achieved in re-entry~     treatment.~   "
252267|NCT00249743|"~     Falls are a public health problem of significant social and economic significance. No primary~     intervention devices have been shown to be effective in reducing falls and associated~     injuries. The objective of this study was to determine whether the new wireless FallSaver~     device reduces falls and fall-related injuries in elderly skilled nursing facility (SNF)~     residents. A randomized, prospective, open-label, cross-over study was conducted over a~     six-month period. The FallSaver device reduced the frequency of falls by 50% and fall-related~     injuries by 82% in 43 elderly at-risk SNF residents studied over 4,222 patient-days. The~     device and associated patch enclosure was well tolerated and devoid of serious problems.~     Significant cost savings and fewer reductions in quality of life are possible if fall-related~     injuries can be reduced.~   "
252268|NCT00249730|"~     To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile~     dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at~     the end of double blind treatment, comparing the group titrated to 100mg vs. the group~     maintained on 50mg.~   "
252269|NCT00249717|"~     The purpose of this study is to evaluate the efficacy of prize-based contingency management~     (CM) when administered exclusively in groups. Substance dependent patients (N=360) at~     community-based treatment programs are randomly assigned to one of two conditions: (a)~     standard, non-CM treatment or (b) standard treatment plus prize CM delivered in groups. In~     the CM condition, patients earn the opportunity to win prizes for attending groups and~     submitting drug-free biological specimens. Substance use and psychosocial problems are~     measured at intake, month 1, month 3 (post treatment), and at 6-, 9-, and 12-month follow-up~     evaluations. We also assess patient characteristics that may be associated with improved~     outcomes within and across conditions.~   "
252270|NCT00249704|"~     The study will explore multiple mobility function tests as well as functional and~     neuropsychological tests in elderly subjects at risk for falls and disability, before and~     after 4-month exercise and/or Vitamin D intervention.~   "
252271|NCT00249691|"~     Although a great amount of research has been conducted to resolve cocaine dependence, an~     effective treatment has yet to be discovered. Topiramate is a drug that was found to be~     useful in treating alcohol dependence. The purpose of this study is to determine the~     effectiveness of topiramate in treating cocaine dependent individuals.~   "
252272|NCT00249678|"~     The purpose of this study is...to assess whether placing a substance abuse intervention for~     HIV+ methamphetamine users within an HIV medical care setting improves rates of follow-up on~     referral to treatment by primary care physicians; reduces drug use and sexual risk behaviors~     more than treatment-as-usual; and increases rates of adherence to HIV medication regimens.~   "
252273|NCT00249652|"~     The purpose of this study is to test a novel distance-based (telephone) intervention to help~     transplant candidates with current or recent substance abuse to stay clean and sober both~     prior and following transplant surgery.~   "
252274|NCT00249639|"~     The purpose of this study is to evaluate the effectiveness of a low-cost contingency~     management procedure as compared to standard treatment. Using a cross-over design, CM is~     implemented at different community-based clinics and compared with non-CM in the same~     facilities. Research staff collects information regarding patients' demographic~     characteristics, attendance, and outcomes at the clinics. During Phase A (non-CM), standard~     clinical practice is in place. During Phase B (CM), all patients have the chance to win~     prizes by coming to treatment. Each participating clinic is randomly assigned to receive~     either the A or B phase first; each phase is in effect for 16 weeks.~   "
252275|NCT00249626|"~     The purpose of this study is to train therapists to administer contingency management (CM).~     This project will train up to 42 community-based treatment providers about the rationale for~     and the specifics of administering CM. Initial training will occur in 2-day workshops,~     followed by weekly supervision in delivery of CM with test cases. We expect that the majority~     of therapists will achieve high levels of competence and adherence in administering CM~     treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the~     efficacy of CM, each therapist who achieves adherence and competence in delivering CM will~     administer standard treatment alone or standard treatment plus CM to substance-abusing~     outpatients. In the CM condition, patients will have the opportunity to win prizes for~     submission of negative samples, and the treatment will be in effect for 12 weeks. In total,~     up to 200 patients will be randomly assigned to one of the two conditions. A research~     evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment~     initiation.~   "
252277|NCT00249600|"~     The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in~     enhancing attendance, reducing drug use, and improving health among clients attending two HIV~     drop-in centers. Specifically, 172 clients are randomly assigned to one of two 6-month~     treatment conditions: standard 12-step oriented group treatment, or CM group treatment. In~     the CM group, clients earn the chance to win prizes for submitting clean urine specimens and~     for complying with steps toward their treatment goals. Activities related to improving health~     will be emphasized, such as attending medical appointments, recording daily medication~     consumption, getting prescriptions filled, and attending medication adherence support groups.~     Group attendance, drug use, medical problems, services received, and risky drug use and~     sexual behaviors will be measured pre-treatment and at months 1, 3, 6, 9 and 12.~   "
252278|NCT00249587|"~     The purpose of this study is to develop and pilot test a combined behavioral and~     pharmacological intervention designed to decrease pain, functional interference, and drug~     abuse while increasing medication adherence.~   "
252279|NCT00249574|"~     The purpose of this study is to see whether street-recruited heroin users can be successfully~     treated for hepatitis C after stabilizing them on buprenorphine.~   "
252280|NCT00249561|"~     The major aim of the project is to document and evaluate two treatments for female offenders~     with substance abuse problems (TC and cognitive behavioral), simultaneously studying the~     process of treatment, and relating treatment process to treatment outcome.~   "
252281|NCT00249548|"~     The purpose of this study is to evaluate the effectiveness of a lower-cost contingency~     management (CM) procedure in Hispanic substance abusing outpatients. Thirty individuals~     meeting DSM-IV criteria for substance dependence receive one of two conditions: (a) standard~     treatment, or (b) standard treatment plus prize CM. Using a cross-over design, CM is~     implemented in a community-based outpatient clinic and compared with non-CM in the same~     clinic. The participating clinic is randomly assigned to receive either the CM or non-CM~     phase first; 15 weeks after the final participant in one phase is enrolled, a one-week~     washout period occurs, followed by a switch to the other phase. Patients initiating~     outpatient treatment during the non-CM phase receive standard treatment and submit urine and~     breath samples 2/week during Weeks 1-6 and 1/week during Weeks 7-12. Patients initiating~     treatment during the CM phase also receive standard treatment and the same breath and urine~     monitoring. In addition, they earn the opportunity to win prizes for coming to treatment and~     for submitting negative breath and urine samples. Follow-up interviews are conducted at 1,3,6~     and 9 months following intake during which substance use and psychosocial functioning are~     assessed.~   "
252282|NCT00249535|"~     The purpose of this study is to compare voucher-based contingency management (CM) procedures~     to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent~     outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus~     usual magnitude prize CM, (c) standard treatment plus higher magnitude prize CM, or (d)~     standard treatment plus voucher CM. Urine and breath samples are collected 2-3x/week for 14~     weeks. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which~     substance use and psychosocial functioning are assessed.~   "
252283|NCT00249522|"~     The purpose of this study is to compare voucher-based contingency management (CM) procedures~     to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent~     outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus~     voucher CM for abstinence, defined by negative breath and urinalysis test results, or (c)~     standard treatment plus prize CM for abstinence, defined by negative breath and urinalysis~     test results. Urine and breath samples are collected 3x/week during Weeks 1-3, 2x/week during~     Weeks 4-6 and 1x/week during Weeks 7-12. Follow-up interviews are conducted 1,3,6 and 9~     months following intake during which substance use and psychosocial functioning are assessed.~   "
252284|NCT00249509|"~     Recent research has identified the following withdrawal symptoms to be associated with~     abruptly stopping marijuana use: anxiety, irritability, bodily aches and pains, and~     difficulty sleeping. These symptoms resemble those of both depression and nicotine~     withdrawal, suggesting that a similar treatment drug may be useful. This study will evaluate~     the effectiveness of two antidepressant drugs, bupropion and nefazodone, in reducing~     withdrawal symptoms in marijuana dependent individuals.~   "
252285|NCT00249496|"~     This application is a competing continuation of a grant in which we developed and pilot~     tested a computerized Therapeutic Workplace designed to train and employ adults as data entry~     operators. A randomized trial is planned over 5 years to investigate the Therapeutic~     Workplace business as a maintenance intervention to sustain long-term abstinence and~     employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk~     for contracting or spreading HIV infection will participate in an initial Therapeutic~     Workplace training phase. Participants who become abstinent and skilled will be randomly~     assigned to an Abstinence & Employment, or an Employment Only group. Participants in the~     Abstinence & Employment group will be employed for one year in a Therapeutic Workplace~     business and will have to provide drug-free urine samples to work and earn salary. Employment~     Only participants will be offered employment for one year, but these participants will not~     have to provide drug-free urine samples to work. This study will provide a rigorous~     evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of~     cocaine addiction and unemployment; determine the benefits of requiring daily evidence of~     abstinence to work; and provide information on the extent to which a Therapeutic Workplace~     business can become self-sustaining. This research could provide firm scientific foundation~     for the dissemination of Therapeutic Workplace businesses in the long-term treatment of~     cocaine addiction and unemployment. The main hypothesis being tested is that cocaine~     abstinence will be reliably maintained during the yearlong intervention evaluation period~     only in the group exposed to the explicit abstinence maintenance intervention. We expect that~     cocaine abstinence in the Abstinence and Employment group will be significantly greater than~     cocaine abstinence in the Employment Only group.~   "
252286|NCT00249483|"~     Preliminary research has shown that venlafaxine, a medication currently used for treating~     depression, may also discourage cocaine use in depressed individuals. This study will~     evaluate the effectiveness of venlafaxine in reducing cocaine use and alleviating depression~     in individuals addicted to cocaine.~   "
252301|NCT00249288|"~     This study aims to examine factors potentially contributing to differences in blood folate,~     homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low~     folate is associated with negative symptoms, and to examine the efficacy of folate~     supplementation for reducing negative symptoms.~   "
252302|NCT00249275|"~     The aim of this study was to compare the effectiveness of two interventions, namely providing~     free spectacles or only a prescription to students with insufficiently corrected or~     uncorrected significant refractive errors.~   "
252303|NCT00249262|"~     To evaluate objective response rate and duration of response to weekly Taxoprexin®.~      To evaluate the safety profile of weekly Taxoprexin® in this patient population.~      To evaluate overall survival in the same patient population. To evaluate time to disease~     progression, and the time to treatment failure in patients with metastatic malignant melanoma~     being treated with weekly Taxoprexin® Injection.~   "
252287|NCT00249470|"~     The primary purpose of the study is to determine if the central feature of the Therapeutic~     Workplace, the abstinence reinforcement contingency, is critical to initiate cocaine~     abstinence in injection drug using methadone patients who use cocaine consistently during~     methadone treatment. All subjects initially will be invited to attend the Therapeutic~     Workplace for an initial period, but abstinence will not be required to work during that~     time. During this initial period, vouchers will be contingent only on workplace attendance~     and performance on the training programs. Subjects (n=70) who attend the workplace~     consistently during the first 4 weeks of treatment, but who continue to use cocaine will be~     randomly assigned to a Work Only or an Abstinence Plus Work group. Subjects in the Work Only~     group will continue to be able to work independent of their urinalysis results. However,~     subjects in the Abstinence Plus Work group will be required to provide urine samples that~     show evidence of recent cocaine abstinence. Subjects in both groups will be invited to stay~     in the workplace for 6 months. We expect the subjects in the Abstinence and Work group will~     achieve higher rates of abstinence than the subjects in the Work Only group. This result~     would show that the abstinence reinforcement contingency (i.e., the requirement to provide~     cocaine-free urine samples to work and earn vouchers) is important in the initiation of~     abstinence in the study population.~   "
252288|NCT00249457|"~     The purpose of this study is to determine whether long-term exposure to the Therapeutic~     Workplace intervention could sustain drug abstinence over an extended period of time in~     heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.~   "
252289|NCT00249444|"~     Many substance dependent individuals also suffer from depression. Past research suggests that~     antidepressant medication is helpful in treating such individuals. This study will determine~     the effectiveness of mirtazapine, an antidepressant medication, in treating cocaine dependent~     individuals who also suffer from depression. This study includes free treatment for cocaine~     dependence that includes medication and a behavioral intervention.~   "
252290|NCT00249431|"~     Pathological gamblers often are also dependent on alcohol and clinically depressed.~     Sertraline (Zoloft) is currently used to treat depression, panic disorder, and~     obsessive-compulsive disorder. The purpose of this trial is to determine the effectiveness of~     sertraline used in combination with relapse prevention therapy in decreasing gambling~     behavior and alcohol consumption in individuals with a diagnosis of pathological gambling and~     alcohol abuse or dependence.~   "
252291|NCT00249418|"~     The purpose of this study is to train therapists to administer contingency management (CM).~     This project will train up to 42 community-based treatment providers about the rationale for~     and the specifics of administering CM. Initial training will occur in 2-day workshops,~     followed by weekly supervision in delivery of CM with test cases. We expect that the majority~     of therapists will achieve high levels of competence and adherence in administering CM~     treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the~     efficacy of CM, each therapist who achieves adherence and competence in delivering CM will~     administer standard treatment alone or standard treatment plus CM to substance-abusing~     outpatients. In the CM condition, patients will have the opportunity to win prizes for~     submission of negative samples, and the treatment will be in effect for 12 weeks. In total,~     up to 200 patients will be randomly assigned to one of the two conditions. A research~     evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment~     initiation.~   "
252292|NCT00249405|"~     This study is being done to determine if citalopram is safe and effective in the treatment of~     alcohol dependence. A second purpose is to evaluate whether alcohol dependent individuals who~     differ in a specific genetic marker respond differently to citalopram.~      Citalopram is a drug approved by the U.S. Food and Drug Administration (FDA) for the~     treatment of depression. It belongs to a category of medications called selective serotonin~     re-uptake inhibitors or SSRIs. The U.S. FDA has not approved citalopram for the treatment of~     alcohol dependence. Therefore, it is being used off-label in this study.~   "
252293|NCT00249392|"~     Environmental and genetic factors may play a role in the progression of ocular diseases~     (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment,~     ocular tumor, etc.). The goal of this project is to establish a series of case-control~     studies to evaluate risk factors of ocular diseases in China.~   "
252294|NCT00249379|"~     The purpose of this study is to test how tolerable and effective acamprosate is when used to~     prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in~     drug court).~   "
252295|NCT00249366|"~     The purpose of this study is to test how tolerable and effective lorazepam is when used to~     treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.~   "
252296|NCT00249353|"~     The purpose of this study is to evaluate the safety and effectiveness of CONCERTA®~     (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for~     the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents..~   "
252297|NCT00249340|"~     The purpose of this study is to compare the effectiveness of Weight Watchers, brief~     behavioral treatment, and a combination treatment. We hypothesize that a combination~     treatment will achieve greater weight losses than Weight Watchers alone.~   "
252298|NCT00249327|"~     This is an evaluation of the effect that an online live action, dramatic vignette about four~     gay men, two HIV positive and two HIV negative, struggling with the responsibility for safer~     sex has on the sexual behavior and HIV testing intentions of the gay/bisexual men who watch~     the vignette and participate in the evaluation study. The primary hypothesis is that men will~     be more likely to: 1)express the intent to have an HIV test and 2) to express the intent to~     inform their sex partners of their HIV status after watching the vignette. The secondary~     hypothesis is that men will be more likely to follow through on these intentions in the three~     months following the intervention than they were in the three months before viewing the~     vignette. This is a one group pre-posttest intervention in which each man serves as his own~     control.~   "
252299|NCT00249314|"~     The purpose of this study is to directly compare the body composition, body fat distribution,~     and morphological and functional features of adipose tissue and skeletal muscle between South~     Asians and European Caucasians.~   "
252304|NCT00249249|"~     The purpose of this study is to compare the efficacy of pitavastatin with that of~     atorvastatin.~   "
252309|NCT00249171|"~     The purpose of the study is to show that risperidone (an antipsychotic medication) combined~     with lorazepam (an anti-anxiety medication) is more effective than conventional therapy~     administered by intramuscular injection for emergency treatment of patients with~     schizophrenia.~   "
252310|NCT00249158|"~     The purpose of the study is to compare the effectiveness of an oral formulation of~     risperidone (an antipsychotic medication) to that of placebo for treating behavioral and~     psychological signs and symptoms in dementia (BPSSD), specifically aggression, delusions, and~     hallucinations, in patients with dementia.~   "
252311|NCT00249145|"~     The purpose of the study is to compare the safety and efficacy of risperidone (an~     antipsychotic medication) to that of placebo in the treatment of behavioral disturbances~     associated with dementia.~   "
252312|NCT00249132|"~     The purpose of the study is to evaluate the effectiveness and safety of different doses of~     risperidone (an antipsychotic medication) compared with placebo and with a fixed 20 mg/day~     dose of a standard antipsychotic, haloperidol, in patients with chronic schizophrenia.~   "
252313|NCT00249119|"~     The purpose of the study is to evaluate the effectiveness and safety of different doses of~     risperidone (an antipsychotic medication) compared with a fixed 10-mg dose of a standard~     antipsychotic, haloperidol, in patients with chronic schizophrenia.~   "
252314|NCT00249106|"~     The purpose of this study is to determine the safety and immune response to a investigational~     DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels,~     in adults who are not infected with HIV.~   "
252315|NCT00249093|"~     The aim of the study is to evaluate effects of supplementary oxygen during exercise on~     dyspnoea and exercise tolerance in COPD-patients given long-time oxygen treatment~   "
252316|NCT00249080|"~     Neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and multiple~     sclerosis are recognized as a major health concern at the present time. There is information~     in magnetic resonance imaging (MRI) studies regarding the role of brain iron in normal brain~     aging that may be enhanced with the use of better scanning equipment and procedures, and by~     correlating this information with clinical data. This research study aims to develop and~     evaluate a number of techniques that can potentially improve the effectiveness of three tesla~     (3T) magnetic resonance imaging of neurodegenerative brain disorders.~   "
252317|NCT00249067|"~     This is a retrospective chart review examining our experience with carvedilol in CHF~     secondary to left-to-right heart shunt lesions. The treatment group will be children who have~     received carvedilol. The control or comparison groups will be patients who have received~     either digoxin/furosemide or captopril for this indication. Charts will be reviewed of~     patients who have been treated at Children’s Healthcare of Atlanta and as outpatients by~     Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have~     been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005~     will be used for this study. We will review approximately 50 charts for this study.~      We will evaluate the effectiveness of these medications at reducing symptoms of CHF.~   "
252318|NCT00249054|"~     This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The~     performance of the devices will be assessed by:~      Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse~     of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.~      Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range~     of motion. Scanning: DEXA and MRI~   "
252319|NCT00249041|"~     The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects~     with Rheumatoid Arthritis~   "
252320|NCT00249015|"~     Endurance exercise such as walking has been shown to help breast cancer survivors maintain~     their energy and quality of life while they are receiving chemotherapy, but there have not~     been any studies on weight training. In this study, the researchers want to determine if a~     combined program of endurance and weight training exercises is better than a standard amount~     of endurance exercise or even a higher amount of endurance exercise in breast cancer~     survivors receiving chemotherapy. The study will be an experimental design in which the~     researchers have breast cancer survivors participate in one of the three different exercise~     programs. The researchers' main interest is in patient rated physical functioning and quality~     of life, which they will measure before and after the exercise programs by asking~     participants how they feel on various rating scales. The researchers will also measure their~     aerobic fitness on a treadmill and how strong they are by having them lift weights.~   "
252321|NCT00249002|"~     This study is designed to confirm the safety of the proposed dose and schedule of ABI-007 for~     hemodialysis patients with vascular access device failure, and to obtain preliminary data on~     the effectiveness of such treatment.~   "
252322|NCT00248989|"~     The purpose of the study is to determine the response of skin parameters related to skin~     aging to the local action of DHEA in postmenopausal women.~   "
252323|NCT00248976|"~     The objective of this randomized trials is to evaluate, among coronary artery disease~     patients who have just had either angioplasty or stents, whether a novel intervention based~     on feedback of individualized risk profiles framed as the opportunity to reduce one's~     biological age is more effective after two years in reducing mortality and major~     cardiovascular morbidity (specifically, myocardial infarction, stroke, class II-IV angina,~     and severe ischemia) than the standard risk reduction approach, which is framed as one's~     opportunity to reduce future risk. The novel strategy is based on the theory of net-present~     value and is tested in coronary artery disease patients who have a high risk of adverse~     outcomes by two years.~   "
252324|NCT00248963|"~     To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of~     LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100~     mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.~   "
252325|NCT00248950|"~     We are interested in achieving an empirical test of the two intervention approaches under~     study. Specifically, we seek to determine the potential differential impact of positive~     affect induction and self affirmation following the qualitative study phase.~   "
252326|NCT00248937|"~     We will conduct an empirical test of the two intervention approaches under study.~     Specifically, we seek to determine the potential differential impact of positive affect~     induction and self affirmation.~   "
252327|NCT00248924|"~     The objective of this prospective study is to document the impact of social service~     interventions (including meals, telephone reassurance, and friendly visiting)provided by the~     Burden Center, a model community social service agency, on overall quality of life.~   "
252328|NCT00248911|"~     Women with breast cancer and other gynecologic cancers often suffer significant distress and~     disability from their disease. A practice of meditation-based stress reduction and~     cognitive-affective-behavioral learning may help women with these conditions decrease their~     suffering and improve their quality of life.~   "
252329|NCT00248898|"~     Long term follow-up of nonagenarians who have undergone open heart procedures.~   "
252330|NCT00248885|"~     It is the long term objective of this study to preserve or improve the quality of life and to~     prevent deterioration in physical and mental function following myocardial revascularization~     among bypass surgery patients.~   "
252331|NCT00248872|"~     The long-term objective is to determine whether better adherence to prescribed medications~     can be achieved through positive affect induction and self-affirmation leading to reduction~     in hypertension-related outcomes such as end-stage renal disease, stroke, and cardiovascular~     mortality among African American patients with poorly controlled hypertension.~   "
252332|NCT00248859|"~     This is an observational study among Latino patients who have coronary artery disease. The~     goal of the study is to determine the association between having depressive symptoms and the~     ability to modify one's health behavior. Specifically, participate in physical activity.~   "
252333|NCT00248846|"~     The long-term objective of this study is to determine whether a positive affect and~     self-affirmation condition added to an empirically demonstrated approach for motivating~     behavior change is more effective than a standard approach in reducing risk factor behavior~     among a high-risk group of patients with coronary artery disease. Thus, the goal of the~     project is to refine and improve strategies for long-term maintenance of physical activity~     among patients post-angioplasty or stent.~   "
252334|NCT00248833|"~     The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76~     MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from~     meningitis.~      This study will vaccinate three groups of people. In the first 2 groups, the study will be~     double-blinded. This means that neither the volunteer or the medical team will know which~     formulation of the vaccine was administered. The third group of volunteers and the medical~     team will know that they are receiving the higher dose of the vaccine.~   "
252335|NCT00248820|"~     This study intends to assess the ability of contrast-enhanced ultrasound in the detection of~     benign and malignant ovarian masses compared to unenhanced ultrasound.~      By using an intravascular contrast agent, this noninvasive and feasible imaging technique~     will allow the investigators to define specific microcirculation patterns in 100 women with~     ovarian lesions.~      The intravascular contrast agent properties will be compared between benign and malignant~     adnexal masses.~      The final purpose of this ultrasonography is to allow the early detection of tumors and to~     improve the characterization between benign and malignant lesions.~   "
252336|NCT00248807|"~     The purpose of this study is to determine how blood pressure and blood flow are controlled~     during head-up tilt in a semi-upright position. In this investigation we are studying blood~     pressure and blood flow to the brain, with and without a medication which lowers blood~     pressure (Vasotec). We will determine how persons with a spinal cord injury are able to~     maintain blood flow to the brain (not get dizzy) as they assume a more upright position and~     their blood pressure decreases.~   "
252337|NCT00248794|"~     The study will investigate the viability of two cognitive rehabilitation strategies to~     improve functional outcomes for people with schizophrenia. Many people with schizophrenia~     experience impairments in cognitive function which limit their abilities. These impairments~     have been shown to precede the onset of illness and represent a vulnerability factor which is~     exacerbated by emerging psychotic symptoms. These impairments affect a range of functional~     domains including symptom severity, work function, symptom management, treatment, and overall~     quality of life. Recognizing the link between cognitive impairment and function, a few~     clinicals and researchers have attempted to remediate cognitive impairments by providing~     cognitive retraining programs similar to those used in traumatic brain injured patients or~     adaptive skills training. Cognitive retraining involves repetitive exercises to increase~     elemental cognitive functions including memory, attention, psychomotor speed, planning, and~     cognitive flexibility. Adaptive skill training involves didactic group exercises in social~     skills, activities of daily living, and symptom management. Each approach has demonstrated~     some rehabilitation benefits. This study will investigate the effectiveness of a combination~     of these two approaches on outcomes in schizophrenia.~   "
252338|NCT00248781|"~     This study is investigating the effects of a home-based resistance exercise program,~     administered via an interactive telecommunications system, in functionally limited older~     veterans.~   "
252339|NCT00248768|"~     The purpose of this study is to determinate if accelerated rTMS treatment over 1.5 days is~     effective for ameliorating depression in Parkinson's disease.~   "
252340|NCT00248755|"~     The objective of this study is to determine the effect of airway surface liquid (ASL) volume~     on mucociliary clearance in cystic fibrosis (CF). A two-isotope nuclear medicine technique~     will be utilized. This pilot trial will include the imaging of n=7 CF subjects and n=7~     healthy subjects. The trial will include one study visit per subject that will take~     approximately 3 hours. Hypothesis: The simultaneous imaging of both a floating and a~     penetrating radioisotope tag will allow the relative effect of airway surface liquid volume~     on mucociliary clearance to be determined when evaluated in CF and normal subjects.~   "
252341|NCT00248742|"~     Patients with ulcerous colitis and Crohn's disease, age 18-60, with a relapse within the last~     18 months and an activity index ≥4, with a long time stress level ≥60 on the perceived stress~     questionnaire (PSQ) were randomized to a stress management intervention program or treatment~     as usual and followed up for 18 months.~   "
252342|NCT00248729|"~     The objective of this study was to compare the utility of etomidate and midazolam in helping~     patients to relax when there was a need for the placement of a ventilation tube by medics who~     were transporting patients to a hospital in an ambulance.~   "
252686|NCT00244127|"~     To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive~     NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the~     R-CHOP regimen.~   "
252343|NCT00248716|"~     Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three~     groups:~        1. Iron deficiency with no anemia~        2. anemia~        3. no anemia and no iron deficiency Following a nutritional questionnaire, parents of all~          toddlers will receive instruction regarding appropriate nutrition in the 2nd year of~          life. Groups 1 and 2 will randomly receive one of two preparations currently in use for~          treatment of iron deficiency in Israel (Aktiron 35 - Ferrous gluconate and Ferripel-3 -~          iron polysaccharide complex). Followup blood count will be taken 3 month after~          recruitment. The study aims to compare the effectiveness of the Iron preparations~          regarding compliance and efficacy.~      The hypothesis is that a significant difference will be detected between the two~     preparations.~   "
252344|NCT00248703|"~     The purpose of this study is to identify patients with persisting tumor cells after standard~     epirubicin-containing treatment to test a non-cross resistant chemotherapy regimen~     (docetaxel) for these patients, and to explore the analysis of disseminated tumor cells in~     bone marrow as a surrogate marker for clinical outcome.~   "
252345|NCT00248690|"~     The purpose of this study is to determine whether treatment guided also by ICP mean wave~     amplitude improves outcome compared to international standard care in patients with SAH.~   "
252346|NCT00248677|"~     Project STORY (Sensible Treatment of Obesity in Rural Youth) will entail a three-arm~     randomized controlled trial to test the effectiveness of interventions designed to promote~     successful weight management in an important population, overweight children and their~     parents in medically underserved, rural settings. The current feasibility study will provide~     pilot data to develop and support a full-scale trial that will be implemented across multiple~     rural counties. In this pilot program, participants will be randomly assigned to one of two,~     4-month long intervention programs that will be delivered in rural communities through~     Cooperative Extension Offices, or to a Wait List Control (WLC) group. The Behavioral~     Family-Based Intervention (BFI) will involve simultaneous, but separate treatment groups for~     both the child and their parent(s). The Behavioral Parent-Based Intervention (BPI) will~     involve groups for only the parent(s). Both programs will take a behavioral lifestyle~     approach to gradually modify dietary and physical activity patterns. The aims of the trial~     and its principal hypotheses are listed below.~      AIMS:~        -  Evaluate the effects on child's standardized body mass index (BMI-z) of BPI and BFI~          delivered via group contacts to overweight children and/or their overweight parents in~          rural counties.~        -  Examine changes in children's dietary intake, physical activity, self-esteem, and body~          image.~        -  Compare the cost-effectiveness of the BPI and BFI.~        -  Evaluate the effects of the BPI and BFI on parent BMI.~   "
252347|NCT00248664|"~     EPIC is a case/control study that seeks to identify the risk factors for interstitial~     cystitis by comparing the experiences and medical histories of 400 women who recently~     developed IC with 400 similar people who do not have the disease.~   "
252348|NCT00248651|"~     Functional dyspepsia is a common gastrointestinal disorder. Symptoms can include stomach pain~     or discomfort, bloating, fullness after eating meals, and nausea. These symptoms often~     interfere with school and work, and weight loss may occur due to dietary restrictions.~      The hypothesis of this study was that antidepressant therapy is more effective than placebo~     in relief of the symptoms of functional dyspepsia, adjusting for psychological and~     psychiatric co-morbidity. The study also examined if antidepressant therapy reduces~     disability and improves quality of life in functional dyspepsia.~   "
252349|NCT00248638|"~     Relative glutamine (GLN) deficiency may contribute to morbidity and mortality in surgical~     intensive care unit (SICU) patients. During critical illness, GLN utilization by the immune~     system, gut mucosa and other tissues exceeds endogenous production and plasma GLN~     concentrations decrease, which may contribute to cellular dysfunction and increase nosocomial~     infection risk and mortality. Conventional GLN-free parenteral nutrition (PN) has a limited~     impact on SICU outcomes and does not repair the GLN deficit. Recent pilot data show that GLN~     dipeptide-supplemented PN decreases nosocomial infections and improves clinical outcomes in~     SICU patients. The process of benefit is poorly understood, but animal and human data suggest~     that GLN treatment correlates with a) up-regulation of cytoprotective molecules in blood and~     tissues [e.g, GSH, specific heat shock proteins (HSPs) and GLN]; and b) improved epithelial~     barrier defenses and immune cell number and function. Properties of L-GLN limit provision in~     solution, but the GLN dipeptide alanyl-GLN (AG) confers stability and solubility in PN~     (AG-PN). Investigators propose a multicenter, double-blind, randomized, controlled phase III~     trial based on our pilot data to test the hypothesis that AG-PN improves clinical outcomes in~     SICU patients requiring PN after cardiac, vascular or colonic operations. Subjects will~     receive either standard GLN-free PN or isocaloric, isonitrogenous, AG-PN until enteral feeds~     are established. Specific Aim 1 is to determine whether AG-PN decreases hospital mortality,~     nosocomial infection and other important indices of morbidity. Specific Aim 2 is to obtain~     novel, mechanistically relevant observational data in the Aim 1 subjects on whether AG-PN a)~     increases serial blood levels of GSH, HSP-70 and -27, and GLN; b) decreases the presence in~     serum of the bacterial products flagellin and LPS and the adaptive immune response to these~     mediators; and c) improves key indices of innate/adaptive immunity. This study is designed to~     delineate the clinical benefit of a major new nutrition support strategy in high-risk SICU~     patients.~   "
252350|NCT00248625|"~     We have completed patient enrollment in the the double blind, randomized, placebo-controlled~     trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of~     non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of~     intravenous NAC in children with ALF for whom no antidote or other specific treatment is~     available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver~     Failure (PALF) Study Registry.~   "
252351|NCT00248612|"~     The proposed project is written as a typical clinical practice test and is a~     fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy (venlafaxine;~     CBT-VEN) delivered for patients with comorbid alcohol-use and anxiety disorders. The CBT and~     pharmacotherapy will be contrasted with relaxation training and placebo medication. One~     hundred and eighty participants will be recruited and, subsequent to a platform of outpatient~     treatment for alcoholism, will be randomly assigned to a 12-week treatment condition. All~     treatment conditions will begin with a 1-week placebo run-in, after which participants will~     begin a trial of venlafaxine or placebo. The treatments will conclude with a 2-week~     medication/placebo taper. Follow-up assessments will be conducted at post-treatment and at 3,~     6, 9, and 12-months. The long-term objectives of this research are to develop a real-world~     combination of psychosocial and pharmacological treatments for patients with comorbid~     alcohol-use and anxiety disorders that compromise prognosis, and to evaluate the~     effectiveness of combined psychosocial and pharmacological treatments that target anxiety~     among patients with this comorbidity.~   "
252352|NCT00248586|"~     An accumulating body of evidence indicates that a specific psychological treatment called~     cognitive behavioral therapy (CBT) is associated with significant reductions in pain and~     bowel dysfunction of irritable bowel syndrome (IBS). Despite its apparent efficacy, the~     clinical effectiveness of CBT (i.e., its generalizability, feasibility, cost effectiveness)~     has not been adequately established due partly to its duration, cost, and limited~     accessibility. As the second generation of IBS treatments undergo development and~     validation, it has become increasingly clear that efficacy demonstration is a necessary but~     not sufficient condition of treatment viability. One potential solution to the problem of~     clinical effectiveness is to develop a briefer, largely self administered version of CBT that~     retains the efficacy of standard CBT but is more transportable, accessible, and less costly~     to deliver. To this end, a two-stage project is proposed. The goals of the first stage will~     be to develop, refine, and pilot test an innovative limited therapist contact-CBT protocol~     patterned after treatments proven effective for painful medical disorders with similar~     pathophysiology as IBS. The primary aim of the second stage is to conduct a small randomized~     clinical trial (N = 75 patients meeting Rome II diagnostic criteria) of standard (10 session)~     version of CBT (S-CBT) and limited contact (4 session) version of CBT (LC-CBT) with reference~     to a wait list control to examine their comparative efficacy on multiple indices, including~     IBS symptoms (primary outcome variable), psychological distress, and quality of life.~     Secondary aims are (1) to identify patient characteristics that predict outcome; (2) obtain~     information regarding active change-inducing mechanisms that may underlie treatment outcome;~     and (3) obtain information regarding possible monetary benefits, cost-effectiveness, and~     cost-benefit of S-CBT versus LC-CBT protocols. Data from this trial would set the stage for~     an R01 funded multicenter study with a large, random, and representative sample that could~     establish the clinical effectiveness of LC-CBT and in so doing make a significant~     contribution toward more efficient and effective care of IBS.~   "
252353|NCT00248573|"~     This is an observational, natural history trial of mechanisms of gut adaptation in adult~     short bowel syndrome (SBS). Patients with SBS (< 200 cm small bowel ± colon) will be studied~     initially 2-9 months after the last small bowel resection and again exactly 6 months after~     the initial study. GCRC-studies will examine intestinal nutrient absorption, gut barrier~     functions and gut mucosal biopsy specimens for markers of nutrient transport and cell~     proliferation and apoptosis.~   "
252354|NCT00248560|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel~     works in treating patients with persistent, recurrent, or metastatic head and neck cancer.~   "
252355|NCT00248547|"~     RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help~     lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.~      PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and~     dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone~     in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.~   "
252356|NCT00248534|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Rituximab may help~     chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs.~     Giving rituximab together with temozolomide and methylprednisolone may be an effective~     treatment for primary CNS non-Hodgkin's lymphoma.~      PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide~     and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's~     lymphoma.~   "
252357|NCT00248521|"~     RATIONALE: Drugs used in chemotherapy, such as~     17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating~     patients with metastatic solid tumors or tumors that cannot be removed by surgery.~   "
252358|NCT00248495|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) and giving them~     before and after surgery may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin~     before and after surgery works in treating patients with stage I, stage II, or stage III~     non-small cell lung cancer.~   "
252359|NCT00248482|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor~     from coming back.~      PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan~     and cisplatin works in treating patients with extensive-stage small cell lung cancer.~   "
252360|NCT00248469|"~     The MEMA kwa Vijana Project is a community randomised trial which aims to assess the impact~     of a targeted intervention on adolescent sexual and reproductive health in Mwanza Region,~     Tanzania. The intervention aims to reduce HIV, STD and unwanted pregnancy amongst adolescents~     by improving reproductive health knowledge and by teaching skills to promote sexual behaviour~     change, and comprises community mobilisation, skills-based education in primary schools, and~     youth friendly health services. The evaluation includes a detailed process evaluation, and~     evaluation of the impact in a cohort of approx. 10,000 adolescents who will be followed for 3~     years.~   "
252361|NCT00248456|"~     This study will evaluate the efficacy and safety of calcipotriol plus betamethasone~     dipropionate ointment compared with calcipotriol ointment in the treatment of patients with~     psoriasis vulgaris for a duration of 4 weeks. The study will focus on the percentage change~     of the psoriasis area and severity index (PASI) from baseline to the end of week 4.~   "
252362|NCT00248443|"~     The MiniMax® study is a multicenter randomized controlled study aimed at demonstrating that a~     combination of non-invasive diagnostic tools are as effective as fiberoptic bronchoscopy and~     bronchoalveolar lavage (FO-BAL) in performing the etiological diagnosis of acute respiratory~     failure in cancer patients.~   "
252401|NCT00247910|"~     The objective of the study is to determine whether psychological therapy (self-help or~     individualized intense stress management) is different than a single drug treatment in terms~     of their effectiveness for lowering blood pressure.~   "
252363|NCT00248430|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. An~     autologous stem cell transplant using the patient's stem cells may be able to replace~     blood-forming cells that were destroyed by chemotherapy. Giving white blood cells from a~     donor may help the patient's body destroy any remaining cancer cells. Interleukin-2 may~     stimulate the white blood cells to kill cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects of donor white blood cell~     infusions and interleukin-2 and to see how well they work in treating patients who are~     undergoing an autologous stem cell transplant for relapsed advanced lymphoid cancer.~   "
252364|NCT00248404|"~     The purpose of this trial is to assess the tolerability and safety of NB1011 in the treatment~     of patients with cancers that overexpress TS, such as ovarian, gastrointestinal, colorectal,~     bladder, breast, and lung cancers.~   "
252365|NCT00248391|"~     Supine feeding position is associated with serous otitis media. The hypothesis is that supine~     feeding is associated with recurrent otitis media, tonsillar and adenoid hypertrophy and~     recurrent pneumonia secondary to recurrent aspiration.~   "
252366|NCT00248378|"~     The purpose of this study is to determine whether or not smoked marijuana improves spasticity~     in patients with multiple sclerosis.~   "
252367|NCT00248365|"~     The purpose of this study is to assess the tolerability and safety of two intensity levels of~     Theralux extracorporeal photochemotherapy in the treatment of subjects with steroid~     refractory or intolerant GvHD.~      The current hypothesis is that apoptotic cells re-injected into patients induce an~     immunomodulation effect alleviating the GvHD symptoms. Using the Theralux procedure, the dose~     of photodynamic treatment may be modulated to achieve the maximal immunomodulatory effects in~     the treated patients.~      The intervention is iterative extracorporeal photochemotherapy of autologous peripheral blood~     mononuclear cells (PBMC) with a rhodamine-derivative TH9402 (drug) and Theralux (device).~   "
252368|NCT00248352|"~     The purpose of this study is to compare two ways to treat patients with Type 2 Diabetes,~     Standard Care or Case-Managed Care.~      In-Patient Standard Care is guided by the assigned cardiologist and Out-Patient Standard Care~     by the existing diabetes care givers.~      Case-Managed care involves a consult with an endocrinologist and counseling from a diabetic~     educator and a dietician.~   "
252369|NCT00248339|"~     The purpose of this study is to determine if the use of epoetin-alpha will allow patients~     with chronic hepatitis C virus infection to be treated with higher doses of~     peginterferon-alpha-2b and ribavirin, thus increasing chances at lower viral levels and~     raising sustained virologic response.~   "
252370|NCT00248326|"~     The investigators' goal with this research is to:~        1. Establish a clinical database and a DNA bank for 1000 individuals with AF and 1000~          individuals without AF.~        2. Directly test the hypothesis that known functional polymorphisms in the coding sequences~          and the promoter regions of cardiac genes (ion channels and genes known to affect~          survival in the setting of left ventricular dysfunction) predispose individuals to AF.~      Over the past decade, advancing techniques and technologies for gene characterization have~     yielded significant clues as to the molecular mechanism of certain human heart rhythm~     disorders. The role of ion channel polymorphisms in subjects with AF is unknown. Similarly,~     it is also not known whether polymorphisms in other genes have an impact on the risk of AF.~      The ability to characterize genomic at-risk profiles would have many potential benefits for~     patient care. Paramount among these is:~        1. Increased oversight or intervention of at-risk subjects, which might prevent unnecessary~          morbidity and mortality due to AF.~        2. Further insight into the pathogenesis of AF, which may lead to preventative or curative~          therapies.~   "
252371|NCT00248313|"~     To assess equivalence in the rates of functional graft survival at 12 months after~     transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and~     Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus~     induction with CsA and Rapamune® followed by discontinuation of CsA and~     concentration-controlled Rapamune®.~   "
252372|NCT00248300|"~     The purpose of this study is determine if a single, early dose of chlorhexidine applied~     within 12 hours after endotracheal tube insertion will reduce the bacteria in the oral cavity~     and the incidence of pneumonia in trauma victims.~   "
252373|NCT00248287|"~     The purpose of this study is to determine the objective response rates produced by irinotecan~     and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.~   "
252374|NCT00248274|"~     Over the past decade, techniques have been refined which permit an enormous amount of~     information relevant to disease mechanisms to be gained from the examination of heart tissue.~     The Cardiovascular Institute has extensive experience with these techniques, and has utilized~     them to examine other heart disease substrates.~      In this study, the investigators propose to obtain heart tissue at the time of cardiac~     surgery which would otherwise be discarded. Their plan is to examine this tissue and~     correlate their findings with clinical data. Their hope is that the proposed study will~     provide insight into atrial physiology, including the molecular mechanisms underlying atrial~     disease and the potential development of atrial fibrillation (AF).~      This will be a prospective registry for atrial tissue. The investigators propose an~     enrollment of 300 subjects, to take place at University of Pittsburgh Medical Center (UPMC)~     Presbyterian over a 5 year period.~   "
252375|NCT00248261|"~     Serotonin re-uptake inhibitors, such as sertraline, are the medication of choice in~     post-traumatic stress disorder. However, it takes several weeks before they ameliorate~     symptoms. Therefore, we will add ziprasidone (vs. placebo) medication during the first four~     weeks of sertraline in order to find out if this strategy accelerates symptomatic relief.~   "
252376|NCT00248248|"~     The primary objective for this study is to evaluate the development, frequency and severity~     of hand foot syndrome (HFS) in ovarian cancer subjects treated with Doxil®, as consolidation~     therapy, on an every two week schedule.~      The secondary objective for this study is to assess one-year progression free survival rate~     (PFS).~   "
252377|NCT00248235|"~     The purpose of this study is to investigate the effect of a progressive therapeutic exercise~     program on specific physical and functional deficits in the neck and shoulder region~     occurring as a result of head and neck cancer treatment.~   "
252378|NCT00248222|"~     The purpose of this study is to examine the feasibility and efficacy of an early supervised~     aerobic exercise program for patients following a minor ischemic stroke.~   "
252379|NCT00248209|"~     A recently completed multi-site double-blind placebo-controlled study found that bupropion~     (Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a~     diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain~     whether bupropion will improve orgasmic function in pre-menopausal women with a primary~     complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder.~     This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis~     of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug,~     and sexual histories will be obtained. Patients who continue to meet screening~     inclusion/exclusion criteria at their baseline visit will be randomly assigned to either~     placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire~     and activity will be assessed by patient diaries, investigator interview of sexual~     functioning every two weeks, and by standardized questionnaire every four weeks. The primary~     endpoint will be the increase in orgasm completion as measured by the Changes in Sexual~     Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal,~     sexual desire, and sexual pleasure as assessed by the CSFQ-F.~   "
252380|NCT00248196|"~     Coronary heart disease is the single leading cause of death in the United States. In 2000, it~     was implicated in 681,000 deaths (1 in every 5 deaths). Myocardial infarction (MI) is the~     major cause of death in patients dying of coronary heart disease, with an estimated incidence~     of 1.1 million new and recurrent cases per year. It is well established that reperfusion is~     the most successful treatment for salvaging myocardium during acute infarction. However,~     despite such treatment, a substantial number of patients still remain at risk of developing~     large infarcts, with reduced left ventricular function and increased mortality. Therefore,~     adjunctive therapies that are designed to reduce ischemic metabolism and cellular injury~     pending successful reperfusion, or to protect myocytes against the undesired effects of~     reperfusion (reperfusion injury), should be beneficial in limiting infarct size. Mild~     hypothermia is one such potential therapy. This study has been designed to evaluate whether~     the adjunctive use of mild hypothermia further reduces the extent of heart damage caused by a~     heart attack.~   "
252381|NCT00248183|"~     This is a randomized, double-blind, placebo controlled, multi-center outpatient study, in~     adults with GAD.~      Patients 18-65 years of age, with the diagnosis of GAD according to DSM-IV criteria, who~     fulfill the inclusion/exclusion criteria, will be enrolled in this study.~   "
252382|NCT00248170|"~     Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females~     who recently underwent primary surgery for breast cancer. Patients will be randomized to~     letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up~     will occur for 5 years after the completion of enrollment for survival and disease status~     updates.~   "
252383|NCT00248157|"~     This multicenter, open-label extension study will evaluate the long-term tolerability and~     safety for patients completing study CSMS995 0802. During this extension study, all patients~     will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2~     years for the treatment of moderately severe to severe NPDR and low risk PDR.~   "
252384|NCT00248144|"~     The study is designed to assess the efficacy and safety of patient-initiated therapy with~     famciclovir 1500 mg o.d. or 750 mg b.i.d. for one day treatment in adult men and women with~     recurrent herpes labialis~   "
252385|NCT00248131|"~     This multicenter, open-label extension study will evaluate the long-term tolerability and~     safety for patients completing study CSMS995 0802. During this extension study, all patients~     will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2~     years for the treatment of moderately severe to severe NPDR and low risk PDR.~   "
252386|NCT00248118|"~     The purpose of this study is to determine: 1) the short-term clinical efficacy and safety of~     bupropion for helping adolescent tobacco smokers quit, and 2) The role of withdrawal symptoms~     in the maintenance of smoking in adolescents.~   "
252387|NCT00248105|"~     Arthritis is a major cause of disability. Of the nearly 70 million persons in the US with~     arthritis and/or chronic joint symptoms, nearly 8 million are disabled because of their~     arthritis. Knee osteoarthritis (OA) and rheumatoid arthritis (RA) are two of its most common~     and disabling forms. Despite evidence that physical activity can improve functional and~     health related quality of life (HRQOL) outcomes and lower health care costs, the proportion~     of the US population engaging in the recommended amount of physical activity is low and even~     lower among those with arthritis. Moreover, there is considerable variation in clinicians'~     promotion of physical activity for arthritis clients. Care providers infrequently ask clients~     about their physical activity behavior and report feeling unprepared to promote physical~     activity.~      This application studies the effects of a behavioral intervention aimed at promoting physical~     activity, including lifestyle physical activity, on arthritis-specific and generic HRQOL~     outcomes. The proposed physical activity management program (PAM) is based on a chronic care~     model in which allied health professionals promote patient self-management activities outside~     of traditional physician office encounters. The program is an individualized counseling and~     referral intervention, conducted by physical activity managers, directed by a theory-based~     comprehensive assessment of individual patient barriers and strengths related to physical~     activity performance. The specific aims of this randomized, controlled trial of 480 clients~     with RA and knee OA followed for 24 months are to test the effectiveness of physical activity~     management combined with physician physical activity promotion (PAM group) compared to~     physician physical activity promotion only (control group) in improving arthritis-specific~     and generic HRQOL, observed measures of function, and objectively measured and self-reported~     physical activity levels. In addition, exploratory analyses will be done to assess whether~     the improvements in HRQOL and physical activity performance associated with the PAM program~     are mediated by increases in physical activity levels and theory-based motivational~     variables, respectively. This study is intended to generate feasible methods by which health~     care providers and health care systems can increase physical activity levels in clients with~     arthritis and to result in widely applicable strategies for health behavior change.~   "
252388|NCT00248092|"~     This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to~     learn if NRP104 produces a high and any other effects like amphetamine and other stimulant~     drugs that are abused. This information will give some indication if NRP104 can be abused.~     NRP104 is an investigational drug. This means that it has not been approved by the U.S. Food~     and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories~     of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are~     used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to~     treat narcolepsy (excessive sleepiness) and for weight loss.~   "
252389|NCT00248079|"~     To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute~     Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in~     native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in~     diameter.~   "
252419|NCT00247663|"~     - To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole~     monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer~     which participated in double blind study.~   "
252390|NCT00248066|"~     The process of re-narrowing of a coronary artery following a revascularization procedure such~     as angioplasty, begins at the time of the procedure. Restenosis has long been considered a~     major problem for effective long-term interventional success. This often results in repeated~     procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel.~      There is a substantial body of literature suggesting that local MYC protein production in the~     injured coronary artery is a major stimulus and potential cause of restenosis that appears~     after stent placement. This study is based upon the hypothesis that stopping MYC protein~     production in the vessel will help reduce restenosis (vessel re-narrowing).~      AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that~     interferes with MYC production.~      This study will evaluate the safety and potential effectiveness of RESTEN-MP to reduce~     in-stent restenosis following balloon angioplasty and stent placement. The post-dose~     follow-up period is up to six-months.~      RESTEN-MP is administered at the time a stent is successfully placed in a coronary artery,~     and again 24 hours later, via slow-push intravenous administration.~   "
252391|NCT00248053|"~     The purpose of this study is to assess if curcumin, a commonly used food spice, can regress~     colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited~     form of colorectal cancer.~   "
252392|NCT00248040|"~     The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear~     neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin~     is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and~     efficacy of reparixin in preventing the delayed graft function (DGF) after kidney~     transplantation.~   "
252393|NCT00248027|"~     Main Research questions:~        1. Who are the patients referred for treatment at the Psychotic Disorders Clinic?~        2. What are the outcomes from treatment for first episode psychosis in multiple outcome~          domains?~        3. What hospital resources are used over the early course of the illness?~        4. How satisfied are patients and family with the treatment and services they received?~          This is an important study that will help us evaluate the service and treatment offered~          by the Psychotic Disorders Clinic's specialized early intervention program,which helps~          young people experiencing early stages of psychotic illness.A growing body of evidence~          suggests that intervening earlier in the course of the illness with specialized and~          complimentary pharmacological and psychosocial treatment may be associated with improved~          outcomes.~   "
252394|NCT00248014|"~     This investigation aims at distinguishing the subjects that react in a favorable way to the~     treatment protocol we propose for the Class II treatment~   "
252395|NCT00247988|"~     Weekly carboplatin and taxotere will be tolerable and effective as second line treatment of~     platinum-sensitive ( >6 month treatment free interval) relapsed ovarian cancer~      Primary efficacy parameter will be response rate (CR and PR) according to RECIST criteria.~      Secondary endpoints will be duration of response, progression free survival and overall~     survival. Toxicity will also be evaluated.~   "
252396|NCT00247975|"~     Breast cancer is very common and afflicts 1 in 9 North American women. The treatment of~     breast cancer often requires the use of chemotherapy including anthracyclines.~     Anthracyclines can damage the heart resulting in heart failure and even death. Clinicians and~     researchers are continually seeking methods that will reduce the toxic effects of~     anthracycline treatment.~      L-carnitine is a substance that is produced naturally in the body and is required for normal~     heart function. Animal studies have suggested that L-carnitine protects the heart from the~     effects of anthracyclines, however this has not been verified in humans.~      This study will assess the potential role of L-carnitine in the prevention of anthracycline~     induced heart damage. The investigators will enroll 144 patients into this study. Patients~     will be randomly assigned to L-carnitine therapy or to standard care (no L-carnitine~     therapy). Patients in the L-carnitine group will receive oral and intravenous L-carnitine~     prior to and after their anthracycline therapy. Patients will undergo regular follow up and~     testing to assess heart function. The investigators believe that patients treated with~     L-carnitine will benefit and have fewer complications associated with anthracycline~     treatment.~   "
252397|NCT00247962|"~     The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the~     treatment of Ankylosing Spondylitis.~   "
252398|NCT00247949|"~     Arterial carbon dioxide partial pressure (PaCO2) is an essential indicator of ventilation and~     respiratory function. It is routinely tested invasively by arterial blood gas analysis (ABGA)~     but recently developed miniaturized carbon dioxide tension sensors promise non-invasive and~     continuous transcutaneous PCO2 (PtcCO2) monitoring. We, the researchers at University~     Hospital, Basel, Switzerland, determined the accuracy of two PtcCO2 monitors (TOSCA 500 with~     Sensor 92, Linde Medical Sensors AG, Basel; and Sentec Digital Monitor with V-Sign Sensor,~     Sentec AG, Therwil) for measurement of single values and trends in PaCO2 in critically ill~     patients, using ABGA as a reference.~   "
252399|NCT00247936|"~     Esophagectomy for benign or malignant disease of the esophagus can be performed using a~     transhiatal technique or Ivor Lewis technique (combined laparotomy with thoracotomy). These~     procedures can be associated with significant morbidity and mortality [1]. Advances in~     minimally invasive technology and surgical techniques have allowed us to explore the~     possibility of performing esophagectomy using minimally invasive surgical techniques.~      Minimally invasive esophagectomy represents a new alternative to conventional open~     esophagectomy. It is a technically demanding operation requiring advanced laparoscopic~     surgical skills, appropriate instrumentation, and thorough knowledge of open esophagectomy.~     Multiple authors have reported the use of video-assisted thoracoscopy or laparoscopy to~     facilitate esophagectomy [2-6]. Most of these reports have utilized a standard laparotomy in~     combination with thoracoscopy to perform esophageal mobilization or laparoscopy with a~     mini-laparotomy to perform esophagectomy. DePaula was the first to report a large series of~     48 patients undergoing laparoscopic transhiatal esophagectomy for benign (n=24) and malignant~     disease (n=24) [7]. In 2 patients, conversion to open surgery was required and 2 others~     required thoracoscopic assistance. Postoperative complications were low in the benign group~     but higher in the carcinoma group. The 30-day mortality rate was 16% in patients with~     carcinoma undergoing laparoscopic transhiatal esophagectomy. DePaula concluded that the~     patients who benefit most from this procedure are those with benign disease. Swanstrom~     recently reported nine cases of laparoscopic total esophagectomy [8]. There were no~     conversions to laparotomy. One patient required a right thoracoscopy with intrathoracic~     anastomosis due to poor viability of the gastric tube. The mean operative time was 6.5 hours~     with a mean hospital stay of 6.4 days. However, the advantages of minimally invasive~     esophagectomy have not been observed. The aim of this prospective trial is to evaluate the~     physiologic outcome, clinical outcome, and quality of life after combined thoracoscopic and~     laparoscopic esophagectomy vs. transhiatal esophagectomy.~   "
252400|NCT00247923|"~     The aim of these studies is to study the natural history, the symptoms of, as well as the~     effect of hysteroscopic resection of endometrial polyps. Furthermore, another aim is to study~     new diagnostic techniques to differentiate between malignant and benign endometrial polyps.~   "
252402|NCT00247897|"~     The purpose of this study is to compare the current standard skin disinfectant solution for~     labour epidurals used at BC Women's Hospital to another common skin disinfectant and to the~     skin disinfectant solution recommended by the Public Health Agency of Canada (PHAC) prior to~     placing special intravenous lines. There is very little information available to guide~     doctors in deciding which is the best skin disinfectant for epidural analgesia. The study~     hypothesis is that the disinfectant solution recommended by the PHAC will be the most~     effective.~   "
252403|NCT00247884|"~     The treatment of HCV-infected IDUs presents multiple challenges, such as adherence to~     therapy, relapse of substance use, re-infection, and co-morbid psychiatric disease. Some~     guidelines recommended that IDUs not be offered HCV treatment until they had stopped all such~     use for > 6 months, raising some questions about fairness and discrimination. Little~     published data exist on HCV therapy in active IDUs. However, extensive evidence exists that,~     when specific programs are developed, IDUs can be successfully engaged in care. In IDUs,~     strategies shown to improve adherence include directly-observed therapy (DOT), cash~     incentives, and comprehensive case management. Weekly interferon dosing now provides a means~     of improving HCV treatment adherence, and makes a DOT approach more practical. Within an~     observational, prospective clinical cohort, we will be able to identify a group of IDUs~     infected with HCV genotype 2 or 3 who would most benefit from treatment for their infection.~     We will design a systematic approach to the determination of their appropriateness for~     treatment, refine the approach to their treatment within a directly observed therapy (DOT)~     setting, and evaluate the success of the approach (defined as the achievement of Sustained~     Virologic Response (SVR)). Taken together, this project will help define a systematic~     approach to HCV infection in the inner city. The hypothesis is that the development of a~     systematic approach for the diagnosis of HCV and the establishment of a directly observed~     therapy (DOT) program for the treatment of HCV infection in IDUs will constitute an effective~     means of controlling the epidemic of this infection within this population.~   "
252404|NCT00247871|"~     We plan to compare data from 300 nasal swab in Vancouver's Downtown Eastside taken in 2001 to~     data obtained in 2005. The nasal carriage rate of MRSA and the specific characteristic of~     each MRSA found will be analyzed. A limited amount of associated information will be obtained~   "
252405|NCT00247858|"~     To analyze microbiological data from MRSA samples obtained through the emergency department~     from 2001-2005. There is a strong clinical suspicion that we are now seeing an outbreak of a~     new strain of MRSA and we plan to better characterize the Vancouver population and complete a~     chart review to assess specific associated factors.~   "
252406|NCT00247845|"~     With the advent of highly active antiretroviral therapy (HAART), it was hypothesized that its~     consistent use could lead to a cure for HIV infection in as little as three years [Perelson,~     1997]. Subsequent research has shown this model to be incorrect [Finzi, 1999]. In addition,~     long term use of HAART has now been associated with significant metabolic abnormalities,~     which could lead to unintended morbidity, possibly worse than what one could expect from the~     progression of untreated HIV-associated immune disease over the same period of time [Carr,~     2000]. Accordingly, current recommendations for antiretroviral therapy have become more~     conservative. It is now suggested that a person with a CD4 count > 350 cells/mm³ may safely~     delay initiation of HAART [Yeni, 2002].However, for those who still require HAART, the risks~     of short-term and long-term toxicities remain, even if full virologic suppression is~     achieved. In this setting, a number of switching strategies have been evaluated (Negredo et~     al, 2002 & Martinez et al, 2003), mostly involving single drug substitutions of a protease~     inhibitor (PI) for a non-nucleoside agent (NNRTI) or abacavir (ABC). In general terms, these~     hae shown that virologic suppression is usually maintained, with improvement in drug-related~     side effects, including metabolic toxicities. A number of patients who are currently taking~     effective HAART are experiencing side effects to one or more of the agents in their regimen~     that is not severe enough to mandate an immediate change in their regimen, but that is having~     a measurable effect on their qualify of life. Over time, these effects may have an impact on~     adherence to therapy and its long-term efficacy. Given the recent availability of ATV~     (+/-RTV), its once daily administration, low pill count and favourable side effect profile,~     it is being used in clinical practice as part of single drug substitution strategies in~     patients exhibiting a maximal response to HAART. There is a clear need to examine this~     practice in a systematic manner to document its occurrence, efficacy and safety.~      We hypothesize that, in patients with maximal virologic suppression on a double class regimen~     (including two NRTIs and an NNRTI or a PI, boosted with RTV or not), and in whom a decision~     has been made to implement a single drug substitution of the NNRTI or PI for ATV (+/-), this~     will lead to an improvement in objectively measured quality of life without any negative~     impact on the virologic efficacy of the regimen.~   "
252407|NCT00247832|"~     This study aims to examine the relationship between the patient's perception of readiness for~     discharge after lobectomy and mobilization rates, frequency of visitation by family and~     friends, anxiety levels and pain levels. We will test the hypotheses that a) those patients~     who walk farther early after surgery and who have more visitors and decreased anxiety and~     pain levels will have a greater self-perceived readiness for discharge and b) that patients~     who receive daily ambulation goals and personal motivation will have higher step rates, and~     therefore have a greater self-perceived readiness for discharge, than those that do not. We~     will monitor patients, during the post-operative recovery period using pedometers to count~     steps taken, visitor log sheets, and questionnaires on the patients' anxiety, pain and~     perceived readiness for discharge. Furthermore, we will examine how the patient's~     self-perceived readiness for discharge is affected by study interventions which include~     ambulation goals and daily personal motivation.~   "
252408|NCT00247819|"~     This investigation seeks to better define the genetic basis for vulnerability to substance~     abuse.~   "
252409|NCT00247806|"~     It is currently assumed that all patients are lactose intolerant post bone marrow~     transplantation. This pilot study is to assess what the incidence of lactose intolerance is~     after bone marrow transplantation in children. This will be done using a lactose breath test.~   "
252410|NCT00247793|"~     Effect of two preoperative oral immune-enhancing nutritional supplements in patients at high~     risk of infection after cardiac surgery: a randomized placebo-controlled study.~      Introduction: In our first study we showed that the use of a preoperative oral~     immune-enhancing nutritional supplement (OIENS) resulted in an improved patients’~     host-defence with a reduction in postoperative infectious morbidity in ‘high-risk’ cardiac~     surgery patients. The use of the OIENS resulted also in less postoperative organ dysfunction.~     Experimental studies have shown that additional glycine results in less ischemia-reperfusion~     damage and that glycine has anti-inflammatory properties.~      Objective: The use of an OIENS in the preoperative period in patients at high risk of~     infection after elective cardiac surgery with the use of cardiopulmonary bypass (CPB) results~     in a reduction in infections as in our first study. The addition of 9.6 gram glycine per~     sachet OIENS results in a further reduction in postoperative dysfunction.~      Design: A prospective randomized placebo controlled study with two oral immune enhancing~     nutritional formula’s and an isocaloric control formula. Patients: Seventy-four consecutive~     patients undergoing cardiac surgery with the use of an CPB who met one or more of the~     following inclusion criteria: Age 70 years or older, mitral valve replacement or cardiac~     ejection fraction less then 40%. Exclusion criteria were age < 18 years, proven malignancy,~     use of corticosteroids, severe renal and liver failure. Definition of a protocol violation~     was the intake of less then 5 L or more then 10 L of the nutritional supplement in the~     preoperative period.~      Intervention: Patients were split up in three groups by concealed randomisation. One group~     received the arginine, omega3-PUFAs and nucleotides enriched formula (OIENS). Another group~     received the OIENS further enriched with glycine (OIENS+glyc). The control group received an~     isocaloric nutritional supplement without the enrichments.~   "
252411|NCT00247780|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia. Pulmonary vein isolation~     (PVI) in the left atrium using radiofrequency energy is a new and promising non-medical~     treatment in patients with symptomatic AF with reported success rates of 65 % to 90 %~     depending on AF classification and ablation procedure. However, the risk of recurrence has~     led to suggestions of how to improve the clinical outcome by tailoring a more efficient~     ablation procedure. A prospective, randomised study with 150 patients with symptomatic AF~     referred for PVI has been initiated and patients are allocated to PVI alone (75 patients) or~     PVI with additional ablation in the right atrium (75 patients). Patients undergo extensive~     monitoring of the heart rhythm during follow-up to document symptomatic or asymptomatic AF or~     atrial flutter. The presence of asymptomatic AF after PVI could potentially affect the~     management of the anticoagulation therapy in these patients. The structural and functional~     changes in the atria after PVI is characterized by new imaging techniques (Tissue Doppler~     Imaging(TDI))of the atria and cardiac neurohormones. TDI may be an effective tool for~     characterising changes in the left atrial function after PVI. Neurohormones may provide new~     information regarding the changes in left atrial function and clinical outcome after PVI in~     patients with AF.~      We hypothesize that:~        -  Among patients with predominant atrial fibrillation, PVI with additional ablation in the~          right atrium is associated with better outcome, i.e. freedom of symptomatic AF/atrial~          flutter overall.~        -  Asymptomatic AF and atrial flutter occur frequently after PVI.~        -  Left atrial volume and systolic function correlates to AF recurrence after PVI.~        -  Neurohormones levels correlates to AF recurrence after PVI.~   "
252412|NCT00247754|"~     Objective:~        1. To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in~          reducing anxiety disorder symptoms in at-risk public school children.~        2. To determine whether parent education and involvement improves outcome in anxious~          children treated with CBT.~        3. To determine the ability of school personnel in a) recognizing classroom behaviors as~          anxiety disordered after targeting training of observable child behaviors e.g.,~          avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and~        4. To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.~      Hypothesis:~        1. A CBT oriented intervention as delivered by school personnel will be superior to an~          attention control procedure in reducing anxiety symptoms in at-risk children.~        2. Children who have parental involvement will post stronger and more enduring treatment~          gains.~   "
252413|NCT00247741|"~     The purpose of this study is to compare two short-acting local anesthetics, articaine and~     lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and~     motor block, recovery time until discharge and complications will be studied.~   "
252414|NCT00247728|"~     The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor~     recurrence in patients with hepatocellular carcinoma following hepatectomy.~   "
252415|NCT00247715|"~     The purpose of this study was to determine which treatment strategy, the step-up or the~     step-down treatment strategy, is the most cost-effective treatment for patients with new~     onset dyspepsia in primary care.~   "
252416|NCT00247702|"~     Oral warfarin anticogulation for the prevention and treatment of patients with venous~     thromboembolism is one of the most used therapies in clinical practice. Patients require~     different dosage to achieve the target therapeutic anticoagulation. Optimal dosage and~     bleeding complication are two most clinical concerns. Besides of multiple individual factors~     (e.g. age, dietary intake, vitamin supplement, drug compliance etc.), some genetic factors~     may determine the drug requirement and safety.~      The cytochrome P450 CYP2C9 is a liver enzyme required for the oxidative metabolism of~     warfarin. The vitamin K epoxide redutase (VKOR) is a liver enzyme associated with the reuse~     of the oxidative hydroquinone form of vitamin K. The VKOR enzyme is the target of warfarin.~     Recent studies revealed both genes may determine the pharmacodynamic of warfarin~     anticogualation. To date, there are more than thirteen identified polymorphism at CYP2C9~     gene. Majority of those variant polymorphisms may decrease the warfarin requirement. The VKOR~     complex subunit 1 (VKORC1) is a newly identified gene. Some polymorphisms also were reported.~      As we know, the Chinese patients need a lower dosage of warfarin in comparison with the~     Caucasian patients. We are interested in finding the genetic causes of Taiwneses Chinese~     patients. In our study we will first identify the polymorphism patterns of these two genes in~     normal population. Then, we will try to find the association between these polymorphism and~     patient warfarin requirement. Our pharmacogenetics study will be valuable for prevention of~     bleeding complication of warfarin treatment in Chinese population.~   "
252417|NCT00247689|"~     Background:~        -  Research has shown that several human genes have been associated with vulnerability to~          substance abuse and dependence. However, little is known about how people with these~          genetic tendencies react to drugs in controlled settings.~        -  Methylphenidate, also known as Ritalin, is commonly prescribed for a number of~          conditions, including attention deficit disorder. Because methylphenidate is widely used~          in studies of brain chemistry and behavior and has relatively low risks associated with~          it use, researchers are interested in seeing how it affects the thinking processes of~          people with apparent genetic vulnerability to drug abuse.~      Objectives:~      - To evaluate whether individuals with apparent genetic vulnerability to drug abuse react~     differently to methylphenidate than people who do not have this vulnerability.~      Eligibility:~      - Individuals at least 18 years of age or older who have participated in the NIDA protocol~     Allelic Linkage in Substance Abuse.~      Design:~        -  Participants will be asked to avoid using a number of over-the-counter medications,~          including antihistamines, cough medicines, and nasal decongestants, for 24 hours before~          the study day. Participants will also be asked to avoid consuming caffeinated beverages,~          nicotine or tobacco products, or alcohol on the morning of the day of the study, and~          will provide a urine sample at the start of the study to be tested for chemicals that~          may interfere with the study.~        -  Because of the nature of the study drug, participants will not be allowed to drive to~          the clinical center on the day of the study. (Return transportation will be arranged.)~        -  At the start of the study, participants will take two tablets (each 1 hour apart), and~          will not be told whether the tablets are the study drug or a placebo.~        -  Participants will give regular answers to questions about mood and thinking processes on~          a computer for approximately 5 hours. Blood samples will be taken during this part of~          the study.~   "
252418|NCT00247676|"~     The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and~     then further 25 patients up to a total of 63 eligible patients. If the study gives good~     results it can be expanded to a total of 160 patients. SU011248 will be administered orally~     daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] with~     provision for dose reduction based on tolerability. All patients will receive repeated cycles~     of SU011248 until disease progression, occurrence of unacceptable toxicity, or other~     withdrawal criteria are met. After discontinuation of treatment, patients will be followed up~     in order to collect information on further antineoplastic therapy and survival~   "
252423|NCT00247611|"~     This study will develop and evaluate the efficacy of an individualized, interactive, computer~     software program delivered in conjunction with clinical care in increasing and supporting~     antiretroviral therapy adherence in HIV-infected individuals.~   "
252424|NCT00247585|"~     The objective is to investigate residual effects of heavy drinking, with or without hangover~     symptoms. The primary aim is to test several hypotheses about residual effects of heavy~     drinking. Hypotheses about how heavy drinking affects next-day performance include direct~     physiological effects of alcohol, alcohol withdrawal effects, and non-ethanol effects, such~     as congeners, or family history of alcohol problems. The investigators will test the~     following hypotheses:~        1. relative to placebo, heavy drinking will degrade next-day performance, and this~          relationship will be mediated in full or in part by quality of sleep;~        2. a high congener alcoholic beverage will affect performance to a greater degree than a~          low congener beverage and this relationship will be mediated by severity of hangover~          symptoms.~   "
252425|NCT00247572|"~     This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to~     learn if NRP104, when injected into a vein, produces a high and any other effects like~     amphetamine and other stimulant drugs that are abused. This information will give some~     indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with~     histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs~     that are used most often to treat attention deficit hyperactivity disorder (ADHD) in~     children, to treat narcolepsy (excessive sleepiness) and for weight loss.~   "
252426|NCT00247559|"~     Despite the wealth of information in the literature regarding the cosmetic applications of~     botulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmetic~     applications, the number of randomised, controlled clinical trials is small. Much of the~     published information is based on open-label studies or anecdotal data. Of the robust trial~     data that is available, the vast majority relates to the treatment of glabellar lines, and~     there is little data available regarding the use of BoNT-A in lateral canthal lines. This~     study aims to determine the optimum dose for the use of BoNT-A in this area.~   "
252427|NCT00247546|"~     The aim of this study is to describe and analyse the effects of multifactorial trial on the~     incidence of falls and injurious falls and on different risk factors of falling among the~     home-dwelling aged.~   "
252428|NCT00247533|"~     There are many reports about the association of coronary artery disease (CAD) and cerebral~     artery stenosis (CAS), which had been proved to induce stroke and cognition decline after the~     revascularization including coronary bypass surgery (CABG) or percutaneous coronary~     intervention. Perfusion defect on nuclear brain scan is also noted to correlate with these~     neurological complications. On the other hand, the perioperative arrhythmia and following~     cerebral embolism was also attributed to be one factor inducing such neurological hazards.~      In the patients with coexistent CAD and CAS (1st group), and also the patients scheduled for~     CABG or percutaneous coronary intervention (PCI) (2nd group), we, the researchers at Far~     Eastern Memorial Hospital, attempted to integrate all the parameters mention above, including~     angiography of coronary and cerebral system, quantitative analysis of nuclear brain scan,~     biochemical profile, and signals of a new ambulatory device which could record the~     electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, in order to define~     the correlation between them. A chorological relation between EEG signals and ECG signals is~     our first target to be worked out. Thereafter, we hope to establish a regression model of all~     involved parameters according to the relation. Such a model, we believe, is essential not~     only to explain the post-CABG neurological complications, but to prevent them.~      Furthermore, for the undetermined ischemic stroke patients who had no obvious culprit artery~     or embolism source, the paroxysmal arrhythmia had long been regarded as the cause. Whether a~     paroxysmal atrial fibrillation, which had not been disclosed by routine ECG, could induce~     most of such a stroke is still not known. With this new ambulatory device which could record~     the electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, we want to~     answer the question.~   "
252429|NCT00247520|"~     The purpose of this study is to see whether rEV131 when given as a nasal spray in a single~     dose to each nostril is safe and can reduce the signs and symptoms of allergic rhinitis (hay~     fever) caused by an allergen challenge. All patients enrolled will be known to be allergic to~     ragweed pollen and will be given ragweed pollen extract in both nostrils 30 minutes after~     either rEV131 or innactive vehicle (placebo). The signs and symptoms (sneezing, itching,~     stuffiness and runny nose) will each be given a score from 0 to 3 by the patient and these~     will be added together and the combined scores from patients treated with rEV131 will be~     compared with those who received placebo.~   "
252430|NCT00247507|"~     The aim of this study is to explore and identify the effects of acetylcysteine, a common~     mucolytic with anti-oxidant property, on alleviating the damage caused by increased oxidative~     stress in hemodialysis patients.~   "
252431|NCT00247494|"~     This study is a substudy of the MAN2 -study (Mycophenol mofetil in Antiretroviral Naïve~     patients 2, see elsewhere in the ClinicalTrials.gov database). In the MAN2 study, HIV-1~     infected patients who are not treated with antiretroviral treatment will be randomized to~     treatment with Mycophenol mofetil (MMF)500 mg BID or a control group without treatment (open~     label). Both patients randomized to treatment with MMF and patients randomized to the control~     group will be asked to participate also in this substudy.~      In this substudy we want to show whether monotherapy with Mycophenol mofetil (MMF) in~     patients infected with HIV-1 can reduce acceleration of atherogenesis by attenuating various~     inflammatory pathways normally involved in progression of atherosclerosis.~   "
252432|NCT00247481|"~     This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of~     ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast~     cancer.~   "
252433|NCT00247468|"~     The study objective is to improve morbidity and mortality of high-risk critically ill~     children. Our hypothesis is that a strict ICU glucose control protocol will decrease~     morbidity and mortality associated with hyperglycemia in a population of high-risk critically~     ill pediatric patients.~   "
252434|NCT00247455|"~     High intake of cereal fibre has been shown to be associated with reduced weight gain and~     improved insulin sensitivity. We hypothesize these effects are due to the short chain fatty~     acids derived from the bacterial fermentation (breakdown) of fibre in the colon (large~     intestine). Insulin resistant subjects will be randomized to receive 2 servings of a~     low-fibre cereal (eg. puffed rice) or 2 servings of a high-fibre cereal (wheat bran cereal)~     per day for one year. The effects of the diets on body weight, appetite, abdominal fat, blood~     short chain fatty acids, glucose, insulin, lipids and hormones will be measured~   "
252435|NCT00247442|"~     The purpose of the study is to develop and evaluate a decision aid to assist women aged 70~     years and over to make an informed choice about whether to continue screening mammography.~   "
252436|NCT00247429|"~     In this study we will assess as a primary objective the effect of venlafaxine retard~     treatment on primary care attended elderly patients with depressive syndrome. We will also~     study secondarily its effects on anxiety, somatic and painful symptoms of depression.~   "
252437|NCT00247416|"~     The purpose of this study is to find better treatment for lung cancer and to find out what~     effects the combined treatment of carboplatin and gemcitabine when given with or without~     dexamethasone have on cancer.~      This study will determine if dexamethasone, when given before standard chemotherapy will~     increase the cancer fighting effects and reduce the side effects of chemotherapy.~   "
252438|NCT00247403|"~     Ionizing radiation produces cancer cell death by creating high levels of reactive oxygen~     species (ROS), such as superoxide and hydrogen peroxide, in irradiated cells. Cancer cells~     are preferentially affected by ROS. The investigators, therefore, propose that interfering~     with the detoxification of ROS will make radiation more toxic to cancer cells. Several~     cellular mechanisms exist to detoxify ROS, and glucose metabolism plays an important role in~     many of these mechanisms. The investigators propose that interfering with glucose metabolism~     will sensitize cancer cells to radiation.~      The investigators' central hypothesis is that 2DG will sensitize cancer cells to ionizing~     radiation by inhibiting the use of glucose to detoxify reactive oxygen species produced by~     radiation. As an initial step to evaluate this hypothesis, the investigators have designed~     this phase I study.~   "
252439|NCT00247390|"~     The purpose of this study to determine the long-term efficacy and safety of ramelteon, once~     daily (QD).~   "
252440|NCT00247377|"~     PURPOSE Obesity is a growing problem in the United States. Severe obesity, known as morbid~     obesity, is defined as being 100 pounds in excess of ideal body weight. Nonsurgical~     treatments for morbid obesity include exercise, dietary restriction, behavior modification,~     and pharmacological intervention. However, it is estimated that most patients undergoing~     nonsurgical treatments for weight reduction will regain their weight within 2 to 4 years~     after treatment. According to the NIH consensus conference in 1991, surgery remains the only~     effective sustained weight loss treatment for morbid obesity. The Roux-en-Y gastric bypass~     (GBP) is currently considered the gold standard bariatric surgical operation. Mean weight~     loss following GBP is approximately 65% of the excess body weight during the first 12 to 18~     months postoperatively. Long-term weight loss is in the range of 55-70% of excess body weight~     loss.~      Recently, the laparoscopic approach to GBP was reported. Wittgrove and colleagues reported~     their results of 75 patients who underwent laparoscopic GBP and demonstrated significant~     short-term advantages with comparable weight loss and reversal of comorbidities compared to~     the open approach. However, GBP might it be done laparoscopic or open approach can~     potentially be associated with significant morbidity and mortality such as anastomotic leak,~     pulmonary embolism, bowel obstruction, and postoperative stricture.~      The FDA recently approved the laparoscopic adjustable banding system (LAP-BAND) for use in~     the United States in June 2001. The LAP-BAND system is a device designed to induce weight~     loss in severely obese patients. It is surgically placed around the proximal stomach to~     create a small proximal stomach pouch and restricted opening, or stoma, through which passage~     of food will be slowed. An inflatable portion along the inner aspect of the band is connected~     to an access port, placed intramuscularly. This enabled stoma adjustments to be made without~     the need for further surgery. The advantages of the LAP-BAND system included no cutting or~     opening of the stomach wall, ability to adjust the stoma and a technically easier operation~     to perform than laparoscopic GBP. We wanted to evaluate if the LAP-BAND procedure is as~     effective as the laparoscopic GBP procedure for treatment of morbid obesity.~   "
252441|NCT00247364|"~     To define the effective dose and tolerability of levetiracetam in individuals with Restless~     Legs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe and~     effective in treating the symptoms of RLS.~   "
252442|NCT00247351|"~     We performed a prophylactic peroperative linear 1-minute cryolesion connecting the tricuspid~     annulus and right atriotomy to prevent IART on 15 consecutive adult patients undergoing~     surgery for congenital heart disease. Conduction time between electrodes placed on both sides~     of the cryolesion was measured on the second postoperative day. Coronary angiography and~     electrophysiology study using an electroanatomic mapping system to assess conduction across~     the line were performed three month after the operation on 13 patients.~   "
252443|NCT00247338|"~     The study is designed to investigate the influence of parenteral nutrition (PN) with low~     nitrogen and calorie supply on the clinical outcome of patients after an operation compared~     to that of traditional PNs.~   "
252444|NCT00247325|"~     In the treatment of coronary heart disease which is the major cause of heart attack, direct~     mechanical treatment with catheters such as the coronary angiography,coronary balloon~     intervention and stenting intervention are the mainstay of therapy in recent years. In that~     procedures, we should use the contrast media, and it may cause kidney toxicity especially in~     the patients with underlying kidney disease and decreased kidney function. We intended to~     find out which contrast agent has less kidney toxicity in the catheter based treatment of~     coronary arterial diseases in patients with underlying decreased kidney function~   "
252445|NCT00247312|"~     The purpose of this study is to determine the most appropriate radiation implant dose for~     palladium-103 monotherapy. Radiation dose is related to potential cure. From previously~     published studies, it appears that the prescribed radiation dose can be reduced by 14-20%~     without any difference in potential cure (in this study, the dose is being decreased 10%).~     Although most patients tolerate brachytherapy well, complications to appear to be related to~     radiation exposure to normal structures (i.e. urethra, rectum and proximal penis). By~     reducing the prescribed dose, it is conceivable that fewer patients will experience side~     effects and complications.~   "
252446|NCT00247299|"~     The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for~     eliminating, among other application, benign vascular lesions and unwanted leg veins. Light~     energy heats the deeper structures of the skin. IPL devices provide a broad wavelength~     spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by~     a reflector and then transmitted through various filters that cut off the lower wavelength~     range of the emitted light; therefore, only those wavelengths longer than these of the~     filters are transmitted.~      objectives:~        1. evaluate and optimize the clinical performance of the Luminis ONE platform for each of~          the aforementioned clinical applications.~        2. Reconfirm the parameter settings for each of the aforementioned clinical applications.~        3. Confirm the user friendly design of the device, in aspects of software (user interface)~          and various technical operational features.~   "
252447|NCT00247286|"~     The purpose of this study is to determine the objective (urodynamic) cure rates and effect on~     patient quality of life after six months of treatment for two different nonsurgical~     management options for genuine stress urinary incontinence in females: weighted vaginal cones~     and formal supervised pelvic floor physiotherapy with biofeedback.~      Hypothesis: Assuming a minimum of six months of treatment, weighted vaginal cones are as~     effective as a formal supervised program of pelvic floor physiotherapy with biofeedback for~     the treatment of uncomplicated genuine stress urinary incontinence in females.~   "
252449|NCT00247260|"~     Brachytherapy is a recent technique used in the treatment of tumours and involves the use of~     radioactive sources brought into close contact with the target tissues. One of the principal~     benefits of brachytherapy is that high radiation doses can be localised within the tumour~     with the consequence of minimal side effects. 32P is a radionuclide ideal for brachytherapy~     as it has high energy beta emitting properties, typically a maximum tissue range of about 8~     mm and a half life of 14.3 days. 32P BioSiliconTM is an active implantable medical device~     encapsulating 32P within the internal microcrystalline structure of highly pure inert silicon~     and acts as a sealed source for the provision of 32 phosphorous.~      Tumours targeted with 32P BioSiliconTM are hypothesized to show a reduction in volume with a~     low incidence of side effects associated with the treatment. Prolongation of survival and~     improved quality of life would be favourable outcomes of the investigational product.~   "
252450|NCT00247247|"~     Multi-centre, randomised, parallel-group study, rater-blinded. Total duration of the study~     per subject is 12 weeks plus a one- to two-week screening period. There are 6 pre-planned~     visits per subject: screening visit followed by 5 visits. Approximately 300 patients~     altogether in up to 25 active German study centres and up to 3 active Lithuanian study~     centres will be randomised.~   "
252451|NCT00247234|"~     This study intends to compare the effectiveness of schema therapy with standard psychiatric~     outpatient care for patients with borderline or avoidant personality disorder.~   "
252452|NCT00247221|"~     The purpose of this study is to compare the effectiveness of a brief family intervention in~     reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17~     years old) who are treated in a hospital emergency department for an alcohol-related event.~   "
252453|NCT00247208|"~     The main purpose of this study is to determine whether implantation of a paclitaxel-eluting~     stent (Taxus™) in saphenous vein graft lesions will reduce the incidence of in-stent~     restenosis after 12 months when compared to a similar bare metal stent.~   "
252454|NCT00247195|"~     This study will develop and evaluate the effectiveness of a culturally based program that~     aims to facilitate entry, retention, and successful treatment in specialized mental health~     services for Hispanics with major depressive disorder.~   "
252455|NCT00247182|"~     This project provides stepped care to college students mandated for alcohol-related offenses.~     Students are first provided with a minimal intervention, a 15-minute discussion of their~     alcohol use. Students who continue to drink in a risky manner are provided with a more~     intensive, hour-long brief motivational interview. By providing more intensive treatment to~     the students who exhibit risky drinking, we hope to maximize the efficiency of campus alcohol~     programs.~   "
252456|NCT00247169|"~     The investigators want to test whether treatment with a natural progesterone intravaginally~     increases the cure rate of cervical intraepithelial neoplasia grade I and II.~   "
252457|NCT00247156|"~     1. We hypothesize that children in the experimental group will show a significant improvement~     over the control group as all food allergens groups and some other relevant allergenic~     substances are desensitized in a systematic way using the NAET® methodology within the~     specified period of study.~   "
252458|NCT00247143|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of higher~     doses of lopinavir/ritonavir, in combination with other anti-HIV medications when~     administered as either the capsule or liquid formulations, among patients who have not had~     full viral suppression despite treatment with 3 classes of HIV medications, and at least 2~     prior courses of treatment with HIV protease inhibitors. In addition, pharmacokinetics of the~     active agents, lopinavir and ritonavir will be measured following administration of both the~     liquid and capsule formulations and compared.~   "
252459|NCT00247130|"~     The present study will compare the hemostasis-maintaining effects of intravenous omeprazole~     and ranitidine in patients with upper gastrointestinal hemorrhage that have undergone~     endoscopic hemostasis, to establish which anti-secretory medication prior to the start of~     oral alimentation is effective in preventing re-hemorrhage after hemostasis.~   "
252460|NCT00247117|"~     The purpose of this study is to examine the effect of metformin on biochemical and~     histological findings in NAFLD patients with insulin resistance syndrome.~   "
252461|NCT00247104|"~     Cranberries have been proved to reduce the rate of urinary tract infections in a population~     of women with recurrent urinary tract infections in previous studies. The purpose of the~     study is to examine the efficacy of cranberries in pregnant women with preterm premature~     rupture of membranes in a)prolonging the latent period (=the time period between the time the~     water broke and delivery of the fetus) and b)reduction of infectious morbidity of both the~     mother and infant.~   "
252462|NCT00247091|"~     We conducted a longitudinal study to assess the immunogenicity of standard-titer measles~     vaccine in HIV-infected and uninfected Zambian children. The study hypothesis was that~     HIV-infected children would have higher rates of primary and secondary measles vaccine~     failure compared to uninfected children, contributing to decreased levels of population~     immunity to measles and facilitating measles virus transmission in regions of high HIV~     prevalence.~   "
252463|NCT00247078|"~     The purpose of this study is to compare the safety and effectiveness of an investigational~     antivenom and the current standard of care (pain management with opioid analgesics) for~     treating patients with a widow spider bite. The working hypotheses are as follows:~        1. the investigational antivenom is more promptly effective at alleviating the pain~          associated with a widow spider bite than routine management with opioid pain medication~        2. the investigational antivenom is as safe a treatment as opioid pain medication in~          treating patients with a widow spider bite.~   "
252464|NCT00247052|"~     The aim of the sudy is to evaluate, through clinical, biological and transthoracic~     echocardiography follow up, the evolution of post operative (cardiac surgery) pericardial~     effusion and mostly to evaluate the efficiency of a non steroidal anti inflammatory (NSAID)~     drug (diclofenac)for this indication.~   "
252465|NCT00247039|"~     To determine the clinical effects of garlic in preventing and treatment of patients with~     chemotherapy related febrile neutropenia.These patients have a very high incidence of~     infections which are not routinely covered by the standard empiric therapy. Adding a non-~     toxic and possibly effective therapy may reduce the risk for infections, synergize the~     empiric antibiotic treatment and may lessen the need for broader spectrum and more severe~     side effects.~   "
252466|NCT00247026|"~     To determine the clinical effects of coenzyme Q10 and Curcumin in improving the cytopenias of~     patients with myelodysplastic syndromes. we propose to explore the efficacy of the natural~     compounds curcumin and CoQ10 in MDS because these two agents possess many of the effects that~     are desirable in MDS.~   "
252467|NCT00247013|"~     The purpose and aim of this study is to test the use of a computer-based, automated~     telecommunications system and its effectiveness in increasing the rates of regular screening~     mammography among women ages 50-74. The system will not only help in scheduling appointments~     but will help women in overcoming any barriers that may deter them from having the procedure~     at all. The programs are designed to be user friendly and easy to implement in clinical~     practice.~   "
252468|NCT00247000|"~     To demonstrate the safety, feasibility, quality of life, primary caregiver satisfaction, and~     cost effectiveness of integrated Home Telehealth care versus standard care in a heart failure~     clinic.~   "
252469|NCT00246987|"~     To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses~     of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.~   "
252470|NCT00246974|"~     The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in~     addition to the standard chemotherapy in patients with advanced or metastatic transitional~     cell carcinoma of the urothelium by estimating the time to progression.~   "
252471|NCT00246961|"~     The purpose of this study is to analyse the effect on quality of life after 3 months of~     treatment after changing adjuvant therapy from tamoxifen to Arimidex.~   "
252472|NCT00246948|"~     This Study si designed as a Prospective clinical controlled randomized trial.~      Background:~      Reviews have demonstrated no or little efficacy for passive conservative treatment modalities~     for patients suffering from sciatica. The results of surgery are conflicting. Cohort studies~     have shown a high efficacy for active treatment modalities in patients with sciatica. The~     current trend in treatment of low back pain without sciatica is focusing on active~     conservative treatment like information and advice to stay active and exercises.~      Aim: To evaluate the efficacy of two active conservative treatment programs for patients with~     severe sciatica.~      Methods: In a prospective clinical controlled randomized trial, 181 consecutive patients with~     radicular pain below the knee were examined at baseline, 8 weeks later at post treatment~     follow-up, and at one year follow-up and MR-scanned at baseline and one year follow-up. The~     treatment consisted of four elements: 1-3 were identical in both groups. 1. Thorough~     information concerning anatomy, pathogenesis, how discs heal without surgery, and~     encouragement to stay as active as possible but to reduce activity if an increase in leg pain~     occurs. 2. Tender love and care. 3. Medication; this was optional and only weak analgesic~     and NSAIDs were recommended.~      Element 4 consisted of two different exercise programs. Symptom guided exercises consisted of~     a variety of back related exercises and optional manual treatment. The exercises were given~     after an algorithm, where different symptoms or a response to exercises determined the~     exercises given. The other group, Sham exercises had voluntary not back related exercises.~     The exercises were aimed at increasing the general blood circulation and maintaining strength~     in the extremities. Outcome measures were functional status, pain, MRI findings, clinical~     findings, and history~   "
252473|NCT00246935|"~     The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on~     the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who~     completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered~     orally once daily. The present study consists of a 28 weeks treatment period, and is an~     extension of the 24-week study APTA-2217-06 (registered study). The study will provide~     further long-term safety and efficacy data of roflumilast.~   "
252474|NCT00246922|"~     The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on~     the long-term safety in patients with asthma, who completed the 24-week evaluation of study~     APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists~     of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05~     (registered study). The study will provide further long-term safety and efficacy data of~     roflumilast.~   "
252475|NCT00246909|"~     Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and~     esophagus. GERD occurs when the lower esophageal sphincter does not close properly and~     stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common~     medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily.~     Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large~     proportion of patients.~      Of particular interest in GERD is the assessment of symptom severity and quality of life, and~     the response of these parameters to treatment. Therefore, a questionnaire to assess GERD~     symptoms was developed (ReQuest TradeMark). An important point to consider when using such a~     questionnaire is to evaluate whether an observed difference in scores after a certain~     treatment represents a clinical effect.~      The aim of this study is to determine the minimal clinically important difference (MCID) in~     patients diagnosed with GERD. During the study, the patients will complete a~     patient-orientated, self-assessed reflux questionnaire (ReQuest TradeMark). Endoscopy will be~     performed at the start of the study. The study duration consists of a baseline period (1 to 3~     weeks) and a treatment period (8 weeks). During the first treatment week, the patients will~     receive either pantoprazole (tablet) or placebo once daily in the morning; for the following~     7 treatment weeks all patients will receive pantoprazole. The study will provide further data~     on safety and tolerability of pantoprazole.~   "
252476|NCT00246896|"~     This is a clinical trial to test the effectiveness of current guideline for the care of older~     adults with Alzheimer's disease. The study focuses on the primary care setting using a nurse~     care manager to facilitate guideline-level care. We are hypothesizing that patients who~     receive guideline-level care will have fewer behavioral problems than those who receive the~     usual care provided in primary care settings~   "
252489|NCT00246727|"~     The primary objective of these two studies is to test the hypothesis that the daily ingestion~     of a dietary supplement, Selected Vegetables and Herbs Mix (SV), which consists of non-toxic~     botanicals containing known anti-cancer and/or immune enhancing components, may prolong the~     survival time of stage IIIB/IV non-small cell lung cancer (NSCLC) patients. Either SV or~     placebo will be added to their daily diet in a double-blind randomized fashion, so that there~     will be 2 chances out of 3 of receiving SV and 1 chance out of 3 of receiving placebo.~        -  Study 1: For newly diagnosed patients who will be receiving or have received less than 4~          weeks of, a standard chemotherapy regimen.~        -  Study 2: For those who have stopped or refuse standard chemotherapy but will receive~          best supportive care.~   "
252575|NCT00245570|"~     To determine the effect of an approved medication being studied in support of a new approach~     in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also~     known as exercise-induced bronchospasm), in patients who have a history of worsening asthma~     after exercise.~   "
252477|NCT00246883|"~     This study will evaluate the effects of NHLBI's employee exercise program, Keep the Beat, on~     blood vessel function. Damage to blood vessels can cause narrowing of the vessels, resulting~     in reduced blood flow to parts of the body such as the heart. Stem cells called endothelial~     progenitor cells, or EPCs, may be able to heal blood vessel damage. Exercise, such as walking~     on a treadmill, can help move EPCs from the bone marrow where they originate into the blood~     stream to help heal the damaged blood vessels. The Keep the Beat program encourages NHLBI~     employees to exercise 15 minutes during the workday and provides exercise facilities to~     accomplish this.~      NHLBI employees who have access to NIH exercise facilities may be eligible for this study.~     Candidates must have no history of heart disease, must not currently be exercising more than~     1.5 hours per week and must not have participated in the Keep the Beat program for 3 months~     prior to entering the study. They are screened with blood tests and blood pressure~     measurements.~      Participants undergo the following tests and procedures before beginning the study and 3~     months after participating in Keep the Beat:~        -  Blood tests to identify EPCs and their function, measure the level of nitric oxide (a~          gas produced by healthy blood vessels), and measure C-reactive protein (an inflammatory~          marker that may be a risk factor for cardiovascular disease).~        -  Brachial artery reactivity study to measure how well the arteries widen. An ultrasound~          device is placed over the subject's artery just above the elbow. The device measures the~          size of the artery and the flow of blood through it before and after a pressure cuff is~          inflated around the forearm.~        -  Treadmill exercise testing to evaluate physical fitness. Subjects exercise on a~          treadmill for as long as they can. An exercise specialist is present throughout the~          test. Heart rhythm and oxygen saturation are monitored continuously and blood pressure~          is measured every 3 minutes.~   "
252478|NCT00246870|"~     This study will use brain imaging to map brain cell receptors for a chemical called GABA, a~     chemical that inhibits the activities of nerve cells. The study includes patients with~     succinic semialdehyde dehydrogenase deficiency, or SSADH (a disorder in which an enzyme~     deficiency disrupts GABA metabolism), their parents, and healthy volunteers. SSADH deficiency~     causes various neurological and neuromuscular problems, including mild to severe mental~     retardation, delays in the acquisition of skills requiring the coordination of mental and~     physical activities (psychomotor retardation), delays in language and speech development, and~     other symptoms.~      Healthy volunteers 18-55 years of age, patients with SSADH between 5 and 24 years of age, and~     parents of patients 18-55 years of age may be eligible for this study.~      Participants undergo magnetic resonance imaging (MRI) and positron emission tomography (PET)~     scanning as follows:~      Magnetic resonance imaging~      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For~     this procedure, the subject lies on a table that is moved into the scanner (a narrow metal~     cylinder surrounded by a magnetic field) wearing earplugs to muffle loud knocking and~     thumping sounds that occur during the scanning process. Scanning time varies from 20 minutes~     to 3 hours, with most scans lasting between 45 and 90 minutes. Participants may be asked to~     lie still for up to 90 minutes at a time. In addition to standard MRI, participants may also~     have new types of MRI that may detect brain abnormalities when regular MRI is normal, such as~     diffusion tensor MRI and magnetic resonance spectroscopy. There are no noticeable differences~     from ordinary MRI scans.~      Positron Emission Tomography~      A catheter (plastic tube) is placed in a vein in the subject's wrist. The subject lies on a~     table with his or her head placed in the scanner. A mask, used to help keep the head still in~     the scanner, is placed over the head. The mask is not uncomfortable and has holes for the~     subject to see through. A radioactive compound called flumazenil is injected into a vein. The~     scan takes about 90 minutes.~      Some children need to be sedated for PET or MRI scans. In these cases, chloral hydrate, a~     standard drug for pediatric diagnostic procedures, is used.~   "
252479|NCT00246857|"~     This study will determine the biochemical and genetic causes of inherited immune diseases~     affecting lymphocyte homeostasis. Lymphocytes are a type of white blood cell that fights~     infections. Normally, the body keeps a precise balance in which lymphocyte growth is matched~     by lymphocyte death. People with constantly enlarged lymph nodes or spleen, along with~     autoimmune disease, immunodeficiency, lymphoma, or other immune problems affecting~     lymphocytes may have an abnormality of the immune system in the cell growth and cell death~     processes that regulate lymphocyte homeostasis.~      Patients who have, or are suspected of having, an inherited lymphocyte homeostasis or~     programmed cell death susceptibility syndrome may be eligible for this study. Relatives of~     patients are also included.~      Participants' (patients and relatives) medical records are reviewed and blood samples are~     drawn for studies to identify genes involved in immune disorders. Tissues that have been~     removed from patients for medical reasons, such as biopsied tissues, may be examined for~     tissue and DNA studies. Relatives are studied to determine if some of them may have a very~     mild form of lymphocyte homeostasis disorder.~      Patients who have an immune problem that the researchers wish to study further will be~     invited to donate additional blood samples at irregular intervals (at least once a year) and~     to provide an update of their medical records at the same time.~   "
252480|NCT00246844|"~     This study will examine whether insulin-producing cells in the pancreas (beta cells) can~     recover in patients with type 1 diabetes who have had a pancreas transplant. In type 1~     diabetes, the body's immune system destroys the beta cells. Patients are treated with insulin~     shots or a pancreas transplant to control their blood sugar. Some experiments suggest that~     the pancreas may have the capacity to recover some of its insulin-producing capacity, but~     that ability is negated by factors such as the continuing immune attack and erratic blood~     sugar levels in patients.~      Patients who have had a pancreas transplant may be in a unique situation to allow their own~     pancreas to regrow beta cells for two reasons: 1) the medicines they take to prevent~     rejection of the transplanted pancreas weaken their immune system; and 2) they have~     near-normal blood sugar levels because of their functioning transplanted pancreas. This study~     will test this hypothesis by sampling blood from patients' hepatic vein, which drains the~     liver and native pancreas and from their iliac vein, which drains the transplanted pancreas.~     This will determine whether insulin is coming from the transplanted pancreas (iliac vein) or~     the liver and native pancreas (hepatic vein).~      Patients 18 years of age and older who have had stable pancreatic transplant function for~     more than 5 years may be eligible for this study. Candidates are screened with a medical~     history and physical examination.~      Participants are admitted to the hospital for 2 days for a full medical examination, blood~     tests and procedures to determine insulin production. The procedures will include the~     placement of catheters in the neck and groin for blood sampling. Participants will be closely~     monitored after the procedures and discharged home if there are no complications.~   "
252504|NCT00246519|"~     There are many medications available for the treatment of high blood pressure (hypertension),~     but finding the right one for a specific patient can be challenging. In fact, it is estimated~     that only 34% of people with hypertension have their blood pressure under control. The~     hypothesis is that genetic differences between individuals influence their response to~     antihypertensive medications. This study is aimed at determining the genetic factors that may~     influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is~     that through this research, we may someday be able to use an individual's genetic information~     to guide the selection of their blood pressure medicine, leading to better control of blood~     pressure, and less need for the current trial and error process.~   "
252505|NCT00246506|"~     This study will determine the most effective treatment strategy for infertile couples who~     present when the female partner is 38 years to the 43rd birthday and the couples are~     determined to have a reasonable chance for success.~   "
252481|NCT00246831|"~     This study will examine how people consider their actions to be under their own control or~     not. The term to describe this feeling of being in control of one's own actions is called~     agency. The sense of agency becomes impaired in disorders such as schizophrenia, in which~     people may feel, for example, as if someone else is controlling their thoughts.~      Healthy, right-handed normal volunteers 18 years of age and older may be eligible for this~     study. Candidates are screened with a medical history, neurological examination, pregnancy~     test for women of childbearing age, and magnetic resonance imaging (MRI) scan. MRI uses a~     strong magnetic field and radio waves to obtain images of body organs and tissues. During the~     procedure, the subject lies on a table that can slide in and out of the scanner (a metal~     cylinder surrounded by a magnetic field) and may be asked to lie still for up to 30 minutes~     at a time.~      Participants undergo functional MRI (fMRI). This procedure is the same as a regular MRI,~     except it is done while the subject performs tasks. This enables researchers to learn about~     changes in brain regions involved in those tasks. The fMRI scan for this study takes about 90~     minutes.~      Before beginning the fMRI procedure, subjects receive training using a Cyber glove device.~     This device allows the researchers to measure the subject's finger movements and display them~     on a screen for the subject to view. The subjects are asked to make hand movements by slowly~     opening and closing the hand while watching the computer displaying an artificial hand.~     During the movements, the subjects' level of control is adjusted and they are asked to~     describe how much control they think they have over the hand on the screen. When the subjects~     become comfortable using the Cyber glove, they enter the MRI scanner to begin the test scan.~      For the fMRI, subjects are given visual instruction on when to begin opening and closing~     their right hand. They move continuously for a 30-second block and then have a 20-second rest~     period. This is repeated, with subjects provided different levels of control over the~     displayed hand in each block. The entire test consists of four runs, each run consisting of~     12 blocks lasting about 10 minutes. When the fMRI scanning is finished, the brain is scanned~     once more using regular MRI.~   "
252482|NCT00246818|"~     This study will compare the effectiveness of Tai Chi (a sequence of slow, graceful body~     movements) and a cardiovascular exercise fitness program in improving physical fitness and~     endurance, reducing stress and improving well-being in adult survivors of cancer. Tai Chi,~     described by some as a moving form of yoga and meditation combined, evolved from martial arts~     and breathing exercises in China hundreds of years ago. This study uses the 24-posture~     standardized Tai Chi. The movements are continuous, smooth, and natural, with the upper and~     lower parts of the body following each other. The entire body is always in motion, with the~     movements performed gently and at a uniform speed. The exercise training program uses an~     exercise machine. The training regimen is adjusted to maintain the individual's average~     training heart rate at 70 to 80 percent heart rate reserve; i.e., 220 minus the person's age.~      Cancer survivors of solid tumor cancers who are between 18 and 65 years of age, whose~     treatment included chemotherapy, biologic agents or vaccines, who have had no cancer~     treatment for at least 24 months, and who have had no evaluable disease within 3 months of~     screening for this study may be eligible to participate.~      Participants are randomly assigned to one of three study groups: Tai Chi, exercise training,~     or a waiting list. Individuals in the Tai Chi and exercise training groups participate in a~     supervised program for 1 hour 3 times a week for 12 weeks in the NIH Clinical Center's~     Rehabilitation Medicine department. Individuals assigned to the waiting list are followed for~     12 weeks during the waiting period and are then assigned to either the Tai Chi or exercise~     program for another 12 weeks as described above.~      At three time points during the study-before starting the program and after 6 weeks and 12~     weeks of practicing the study intervention or being on the waiting list-participants undergo~     the following procedures:~      Complete questionnaires regarding their quality of life and stress~      Rehabilitation medicine evaluation, including the following:~        -  Questions about managing their daily activities, whether their skills have changed over~          time, what they may or may not have been able to do, or what they may have had to~          overcome as a result of their previous illness and the study program they have been~          practicing~        -  Measurements of strength and mobility~        -  Evaluation of overall physical fitness and endurance~        -  Blood tests to measure blood cell counts and cholesterol, lipid, hormone and mineral~          levels~   "
252483|NCT00246805|"~     The purpose of this study is to monitor heart rate regularization in patients with permanent~     atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).~   "
252484|NCT00246792|"~     Research and intervention programs for students with learning disabilities (LD) typically~     address child and family characteristics without examining the school context and conditions~     that affect adjustment. Focusing on the student with LD can highlight the child and family’s~     deficits. An ecological theoretical framework guides this research project, a collaboration~     of the University of Toronto, Faculty of Social Work and Ontario Institute for Studies in~     Education of the University of Toronto (OISE/UT), Integra and the Toronto Catholic District~     School Board. This framework is based on the assumption that people are very much part of and~     affected by social and environmental settings. Accordingly, it is important not to see the~     adjustment problems of children with LD as being caused only by their LD. Instead, their~     academic and social problems are seen as unfolding in larger circumstances that include other~     children, the classroom, the school, the family and the community. These many factors act~     together to influence the child with LD and must be taken into account along with individual~     characteristics of the child.~   "
252485|NCT00246779|"~     Cardiac surgery is a major consumer of blood products worldwide. The nature of the surgery~     when the heart-lung machine is used, is such that the patient's blood is significantly~     diluted by intravenous fluids. This dilution further compounds the blood's ability to form~     blood clots to seal the wound, thus increasing bleeding after surgery. The problem of this~     dilution is particularly severe in patients with low body weight, of whom a large percentage~     are women undergoing heart surgery. As a result, in this population there is an increased~     risk of needing a blood transfusion during and after surgery. The effects of this dilution~     can be potentially reversed by filtering the blood and removing the fluid after the principal~     part of the procedure has been completed through a process referred to as modified~     ultrafiltration (MUF). This procedure has been shown to be effective in several small~     clinical studies, however the interpretation of the results has been complicated by the fact~     that the studies were not blinded. In other words, because the physicians and surgeons~     making the decisions about blood transfusions knew what treatment the patients received (i.e.~     MUF or not) it may have biased their judgement and affected the validity of the findings of~     the studies. The investigators believe that MUF may be a useful procedure to limit blood~     transfusions, particularly in patients of low body size, and weight undergoing heart surgery.~     This can only be demonstrated in a large clinical trial, and in the best case scenario, in a~     trial in which total blinding has been undertaken. However, blinding in this manner is quite~     difficult to achieve and it is necessary first to demonstrate that this is possible. Further,~     as the trial will involve several heart centers, it is essential to demonstrate that the~     relatively complex study interventions can be carried out in each of the centers in a~     reproducible manner. With this data in hand, the investigators will be able to submit for~     funding at a later date for a very large trial to determine if MUF decreases the need for~     blood transfusions in heart surgery patients. The investigators will also be able to~     determine the effect of this in terms of helping conserve blood as a benefit to the~     blood-banking agency (the Canadian Blood Service).~   "
252486|NCT00246766|"~     To enable an investigation of fetal movements, the researchers have developed a multichannel~     ultrasound pulsed Doppler called ACTIFOETUS. This new fetal monitor includes three~     transducers of four sensors which are placed on three different zones of the mother's~     abdomen. One of the transducers is aimed at the fetal heart, another at the lower limbs and~     one transducer at the thorax and the fetal upper limbs to detect heart and body movements.~     The signals are analysed and processed by software which computes a number of parameters~     describing the movements.~      Ninety pregnant women from 28 weeks gestation will be monitored over a 40 minute period every~     month or every 2 weeks in case of pathological pregnancy. The final purpose will be to~     develop a system of home monitoring as an indicator of fetal well-being.~   "
252487|NCT00246753|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with~     prostate cancer that did not respond to hormone therapy.~   "
252488|NCT00246740|"~     The purpose of this study is to determine whether doxycycline (Periostat) at a~     sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting~     (CABG) surgery with cardiopulmonary bypass (CPB).~   "
252490|NCT00246714|"~     A number of diseases lead to a so called systemic inflammatory response syndrome (SIRS). This~     excessive response is self-destructive and leads to major complications of the initial~     disease: dysfunction of the microcirculation, systemic vasodilation, and increased capillary~     leakage and oedema. Animal studies have shown that pre-treatment with endotoxin~     (lipopolysaccharide or LPS) suppress the excessive immune response and when rechallenged, the~     animal survive a normally lethal dose of endotoxin.~      Besides a diminished cytokine response, an increased production of leucocytes in the bone~     marrow and an increased phagocytosis after pre-treatment with endotoxin is seen. The~     combination of these factors: diminished systemic inflammatory response and increased~     cellular immunity makes that endotoxin tolerance is a useful tool for preventing the~     complications after an excessive inflammatory response.~      Further, the presence of cross-tolerance has also been shown: Endotoxin tolerant mice survive~     more after induction of a normally lethal fungal infection. Endotoxin tolerance is also~     protective for ischemia/reperfusion injury in kidneys, heart and liver. Little data is known~     about endotoxin tolerance in human.~      The purpose of this study is to induce a state of tolerance through 2 different~     administration schedules and monitor the effect of tolerance on pro- and anti-inflammatory~     cytokines, other inflammatory parameters and different proteins involved in the signalling~     pathway. The effects of tolerance on vascular reactivity will be determined. Finally, the~     effect of tolerance on ischemia-reperfusion injury will be investigated.~   "
252491|NCT00246701|"~     The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters)~     [formerly known as Omacor] combined with simvastatin for lowering non-high-density~     lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite~     statin therapy.~      Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.~   "
252492|NCT00246688|"~     The purpose of this study is to determine if this epothilone leads to a response in patients~     with recurrent ovarian cancer that has progressed during, or in the last six months since a~     treatment of platinum-based chemotherapy. We also aim to look at the safety of the study drug~     and assess the impact of the infusion duration on tolerability.~   "
252493|NCT00246675|"~     The purpose of the project is to test whether or not the commonly used medication frusemide,~     given after heart surgery, and aiming to increase urinary output can have an effect on kidney~     function.~   "
252494|NCT00246662|"~     This study primarily determined the safety and tolerability of escalating doses of vosaroxin~     (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a~     recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential~     biomarkers and antileukemic activity.~   "
252495|NCT00246636|"~     The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid~     ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of~     patients with very high triglycerides.~      The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of~     adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects~     treated with fenofibrate in lowering serum triglyceride (TG) levels.~   "
252496|NCT00246623|"~     This study will examine how to dose Exubera (inhaled insulin) in patients who are not well~     controlled on two or more diabetes pills. This study should show that a large number of~     patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that~     have been set by the American Diabetes Association (ADA). Target goals should be achieved by~     adjusting the Exubera dose either weekly or twice weekly. Patients will also receive~     nutritional counseling and diabetes education as part of the study.~   "
252497|NCT00246610|"~     This study is an evaluation of the safety of 625 mg formulation when administered to~     HIV-infected pregnant women from their second trimester through six weeks postpartum. The~     study will also evaluate the pharmacokinetics of VIRACEPT~   "
252498|NCT00246597|"~     The purpose of this study is to determine whether it is possible to measure temporary~     difficulty with thinking and/or short-term memory in women who are receiving chemotherapy for~     early stage breast cancer and to determine whether or not treatment with PROCRITÂ® will help~     decrease any problems with thinking or short-term memory that chemotherapy may cause.~   "
252499|NCT00246584|"~     This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients~     with essential hypertension. (Trial is not recruiting in the US)~   "
252500|NCT00246571|"~     The purpose of this study is to compare progression free survival for SU011248 [sutent~     (sunitinib malate)] versus standard of care therapy in patients with previously treated,~     advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast~     cancer.~   "
252501|NCT00246558|"~     The purpose of the study is to investigate the prevalence of pain in the anterior part of the~     knee, amongst youngsters between 16 and 18 years of age.~      Furthermore, this trial intends to study the connection between the pain, hyperpronation of~     the foot and tight Achilles tendon.~      We want to find out if there is a need of an early effort in terms of information, training~     and/or support for the shoes.~   "
252502|NCT00246545|"~     The aim of the study is to evaluate the effect of early onset of exercise training (ET) after~     myocardial infarction (MI) in a randomized controlled trial. Usual care is to wait 4-6 weeks~     after onset of MI, and our hypotheses are that early ET will prevent a fall in VO2peak and~     contribute to better quality of life.~   "
252503|NCT00246532|"~     Opiates such as morphine are the cornerstone medications for the treatment of moderate to~     severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become~     more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that~     analgesic tolerance to opioids (habituation) develops during chronic use even though this~     phenomenon has never been prospectively studied. Our specific aims propose to prospectively~     test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent~     tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and~     hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced~     hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance~     and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study~     will be the first quantitative and prospective study of tolerance and hyperalgesia in pain~     patients and will have important implications for the rational use of opioids in the~     treatment of chronic pain.~   "
252506|NCT00246493|"~     The prevalence, incidence, and severity of atherosclerotic disease all markedly increase with~     age. Basic experimental and observational data demonstrate that aging magnifies the~     pathologic and clinical consequences of established risk factors and is the most potent~     individual risk factor for coronary atherosclerosis and for adverse outcomes following an~     ischemic event. These findings suggest that normal aging alters the vascular substrate so as~     to promote the development and progression of atherosclerosis. The age-associated changes in~     vascular structure and function include an increase in central vascular stiffness, intimal~     proliferation, and endothelial dysfunction. The major hypothesis is that the above~     alterations in vascular substrate (i.e. vascular age) are an important determinant of the age~     associated increased likelihood for the development and progression of coronary~     atherosclerotic disease.~      This program will non-invasively characterize vascular age and atherosclerotic burden in BLSA~     participants and individuals with successful aging, i.e. those with no or minimal evidence of~     coronary atherosclerotic disease, and those with premature, clinically evident coronary~     artery disease. It will repeat measures of vascular age and atherosclerotic burden three~     years after the first assessment. By examining the impact of vascular age on the initial~     extent and the progression of atherosclerotic burden over a two to three-year period, it will~     test the hypothesis that vascular age is an important determinant of the ageassociated~     increase in atherosclerotic disease.~   "
252507|NCT00246480|"~     Respiratory syncytial virus (RSV) causes sickness and deaths in older people every winter.~     This study will investigate how aging affects the body's immune response (body's response to~     disease) to RSV. About 2000 people, age 21 and older, who reside in the upstate NY area, will~     be recruited. Two groups of subjects will be studied. The 1st group of volunteers will be~     recruited prior to the start of RSV season in year 1 of the study. These volunteers will~     include healthy people and people with various medical conditions. The 2nd group of~     volunteers will be patients admitted to Rochester General Hospital for acute respiratory~     illness. Procedures will include drawing blood from a vein in the arm (2 tablespoons),~     collecting nasal swabs, and collecting sputum. Volunteers may participate in study related~     procedures for up to 3 years.~   "
252508|NCT00246467|"~     One hundred and five subjects will be recruited into three groups. Each subject will receive~     two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant~     antigen proteins).~   "
252509|NCT00246454|"~     The purpose of this study is to determine the properties of circadian rhythms and sleep~     propensity in familial advanced and delayed sleep phase syndrome (DSPS).~   "
252510|NCT00246441|"~     The purpose of the study is to determine whether an SSRI, paroxetine, improves social anxiety~     symptoms and alcohol use in individuals who drink to cope with social anxiety disorder.~   "
252511|NCT00246428|"~     The purpose of this study is to determine whether motivational interviewing is effective in~     reducing alcohol consumption and alcohol problems among young adults who present to an~     Emergency Room.~   "
252512|NCT00246415|"~     The purpose of this study is to obtain a preliminary indication of the safety and~     effectiveness of oral memantine (40 mg/day) in alcohol dependent patients. This study is a~     16-week study comparison of memantine and placebo in patients with alcohol dependence.~   "
252513|NCT00246402|"~     The purpose of this study is to test whether chronic administration of the drug acipimox will~     improve hyperlipidemia and insulin sensitivity among HIV infected patients experiencing~     highly active antiretroviral therapy (HAART) associated metabolic disturbances.~   "
252514|NCT00246389|"~     The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl~     5 mg (muscle spasm medication) taken three times a day, alone or in combination with~     ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the~     treatment of back or neck muscle pain with muscle spasm.~   "
252515|NCT00246376|"~     This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and~     fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or~     dyslipidemia.~   "
252516|NCT00246363|"~     There is some information available that indicates that Milk Thistle is an effective~     treatment for liver disease. This study will compare Milk Thistle with a placebo, (a medicine~     that looks just like Milk Thistle but does not contain any Milk Thistle) to see if people~     with both Hepatitis C and HIV infections show improvement or cure of Hepatitis C. The study~     will last one year.~   "
252517|NCT00246350|"~     This study will determine the effectiveness of spinal manipulation in reducing pain in people~     with chronic headaches accompanied by neck pain. This study will also determine the number of~     spinal manipulation treatments necessary for optimal pain relief.~   "
252518|NCT00246337|"~     The purpose of this study is to investigate the efficacy and safety of an MK 0974 for~     migraine headache and to identify an appropriate dose range for further study.~   "
252519|NCT00246324|"~     To evaluate the efficacy, safety, and tolerability of combination therapy with intramuscular~     interferon beta-1a and oral doxycycline, a potent inhibitor of matrix metalloproteinases, in~     patients with relapsing remitting multiple sclerosis (RRMS) having breakthrough disease~     activity.~   "
252520|NCT00246298|"~     The purpose of this study is to determine if PROCRITÂ® (a glycoprotein that stimulates red~     blood cell production) initiated at once every 2 weeks dosing is as effective as PROCRITÂ®~     initiated at once a week dosing, in increasing hemoglobin levels in anemic HIV-infected~     subjects.~   "
252521|NCT00246285|"~     The purpose of the study is to assess the safety and effectiveness of risperidone (an~     antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment.~   "
252522|NCT00246272|"~     The purpose of this study is to evaluate the maintenance of clinical effect of a~     rapidly-dissolving tablet form of risperidone (an antipsychotic medication) in adult~     schizophrenia patients switched from their previous equivalent dose of RISPERDAL® tablets~   "
252523|NCT00246259|"~     The purpose of this study is to evaluate the effectiveness, safety and tolerability of~     risperidone long-acting injection (LAI) versus oral antipsychotics in participants with~     recent onset psychosis (abnormal thinking and/or hallucinations).~   "
252570|NCT00245635|"~     This trial will study the effectiveness of the medication fluoxetine for children and~     adolescents ages 16 and younger with BDD who qualify.~   "
252524|NCT00246246|"~     The purpose of this study is to determine the safety and effectiveness of a long-acting~     injectable formulation of risperidone in stable bipolar patients randomly switched from their~     current add-on oral antipsychotic (olanzapine, risperidone, or quetiapine) therapy to~     long-acting injectable risperidone. The patients switched to long-acting injectable~     risperidone will be compared to patients who continue on their oral antipsychotic treatment~     regimen~   "
252525|NCT00246233|"~     The purpose of this study is to evaluate the effects of the addition of CONCERTA®~     (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) or placebo in adult~     outpatients with Major Depressive Disorder who are currently being treated with oral~     antidepressant medication (selective serotonin reuptake inhibitors or selective norepinephine~     reuptake inhibitors). The general symptoms of depression will be evaluated, as measured by~     the Montgomery Asberg Depression Rating Score (MADRS) on fatigue, energy, and overall~     severity of illness. The safety and tolerability of the CONCERTA® and antidepressant~     combination therapy will also be assessed.~   "
252526|NCT00246220|"~     The purpose of this study is to evaluate the effectiveness and safety of three doses of~     prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult~     patients with attention deficit/hyperactivity disorder (ADHD).~   "
252527|NCT00246207|"~     The purpose of this pilot study is to evaluate the safety, tolerability and potential~     effectiveness of CONCERTAÂ® (methylphenidate hydrochloride extended-release tablets), a~     central nervous system (CNS) stimulant for the treatment of adults with Attention Deficit~     Hyperactivity Disorder (ADHD).~   "
252528|NCT00246194|"~     The purpose of this study is to examine treatment practices of adult schizophrenia patients~     by their own doctors, and to assess patient outcomes when treated with long-acting~     risperidone injection over a two-year period of observation.~   "
252529|NCT00246181|"~     This clinical trial involves a radiation treatment called stereotactic radiotherapy in~     non-small cell lung cancer patients who have been determined to be ineligible for surgery.~     This treatment differs from conventional radiotherapy in the number of treatments, the~     radiation dose given per treatment, and the way the radiation beams are directed toward the~     cancer.~   "
252530|NCT00246168|"~     The purpose of this study is to assess the effectiveness of ULTRACETÂ® (a combination~     analgesic) as add-on therapy in rheumatoid arthritis patients taking an NSAID (e.g. AdvilÂ®,~     MotrinÂ® or other nonsteroidal anti-inflammatory drug) or a COX-2 inhibitor (e.g.~     CelebrexÂ®).~   "
252531|NCT00246155|"~     The purpose of this study is to analyse the changes in back muscle size and strength~     following use of Dysport®, and to establish whether there is any association between pain~     reduction and change in strength, in patients suffering from chronic low back pain.~   "
252532|NCT00246142|"~     The purpose of this study is to determine whether electrical stimulation enhances the effect~     of botulinum toxin type A (Dysport®) on myofascial pain syndrome.~   "
252533|NCT00246129|"~     The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years~     has substantially reduced the risk of rejection after kidney transplantation, has allowed the~     development of immuno-suppressive regimens that do not use long-term steroids (steroid~     avoidance), and has improved transplant success rates both in the short and medium term.~      The main new agents used in these modern regimens are the calcineurin inhibitor tacrolimus;~     the anti-proliferative agent mycophenolate; and induction agents which are used to provide~     effective early suppression of the rejection process; these include monoclonal antibodies~     (MoAb) such as IL-2 receptor blocking antibodies (IL-2R MoAb: basiliximab and daclizumab) and~     the anti-CD52 antibody Campath-1H (alemtuzumab).~      Although almost all modern immunosuppressive regimens involve one or more of these agents, it~     is not known which is the safest and most effective combination.~      This randomised controlled trial compares two steroid sparing regimens which have been used~     with very good short and medium term results at St Mary's Hospital Renal and Transplant Unit~     over the last 5 years. The primary hypothesis is that the alemtuzumab/tacrolimus regimen is~     as effective and safe as the IL-2R MoAb/tacrolimus/mycophenolate regimen.~   "
252534|NCT00246116|"~     For this companion protocol, we intend to make an assessment of both tumor response and local~     tissue effects. Patients undergoing the correlative investigation will be a subset of the~     patients already enrolled on the phase II study.~   "
252535|NCT00246103|"~     This is a Phase I dose escalation trial with escalating doses of Valproic acid and one dose~     escalation step of epirubicin. VPA will be escalated starting at a dose that is recommended~     for use as an anti-convulsant or to treat migraine headaches. Epirubicin will be given by~     infusion on day 3 after the last dose of divalproex. The study will determine the highest~     dose that these two drugs can be given together and as part of a multidrug regimen with~     5-fluorouracil and cyclophosphamide.~   "
252536|NCT00246090|"~     The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with~     locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane,~     and capecitabine as prior therapy, and who are refractory to the last prior therapy for their~     disease.~   "
252537|NCT00246077|"~     This study is being done to see what impact having a Lifeport device has on quality of life~     for children with sickle cell who are getting chronic transfusions, from the child's~     perspective.~   "
252538|NCT00246064|"~     The purpose of the study was to evaluate the ability of a maintenance dosage regimen of~     infliximab to achieve and sustain at least 40% improvement from baseline in the total joint~     count in patients with active Rheumatoid Arthritis (RA) during methotrexate tapering.~   "
252571|NCT00245622|"~     This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell~     therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple~     sclerosis (RR-MS).~   "
252572|NCT00245609|"~     The primary purpose of the trial is to assess how effective pregabalin, alprazolam, and~     placebo are at reducing anxiety levels of subjects who take a dose of these treatments 4~     hours before a scheduled dental procedure.~   "
252573|NCT00245596|"~     The purpose of the study is to assess the sensibility of the ISL questionnaire.~   "
252576|NCT00245557|"~     The purpose of this study was to use Magnetic Resonance Images to further our understanding~     of predictors and markers of treatment response and non-response in geriatric depression. We~     hypothesized that concentrations of high energy metabolites would be lower in depressed~     elderly compared to non-depressed.~   "
252539|NCT00246051|"~     Police officers work some of the most demanding schedules known, which increases their risk~     of sleep deprivation and sleep disorders. The need to work frequent overnight shifts and long~     work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of~     circadian phase. The public expects officers to perform flawlessly, but sleep deprivation and~     unrecognized sleep disorders significantly degrade cognition, alertness, reaction time and~     performance. In addition, both acute and chronic sleep deprivation adversely affect personal~     health, increasing the risk of gastrointestinal and heart disease, impairing glucose~     metabolism, and substantially increasing the risk of injury due to motor vehicle crashes.~      We propose to conduct a randomized, prospective study of the effect on the safety, health,~     and performance of a police department of a Comprehensive Police Fatigue Management Program~     (CPFMP) consisting of the following interventions:~        1. identification and treatment of police with sleep disorders;~        2. caffeine re-education; and~        3. initiation of a sleep, health and safety educational program.~      These interventions were chosen because we believe them most likely to lead to measurable~     improvements on work hours, health, safety, and job performance, and because they are cost~     effective. The success of the CPFMP will be assessed through an experimental comparison with~     a standard treatment group that will receive sleep education in the absence of any~     accompanying interventions. The overall goal of our team will be sleep health detection and~     treatment program that can be disseminated to practitioners, policymakers and researchers~     nationwide to reduce police officer fatigue and stress; enhance the ability of officers to~     cope with shift schedules; improve the health, safety and performance of law enforcement~     officers; and thereby improve public safety.~   "
252540|NCT00246038|"~     A prospective, actively controlled, consecutively enrolling, non-randomized multi center~     clinical evaluation of the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft~     when used in the treatment of patients with AAA (Treatment Group) as compared to patients~     treated with conventional open surgery (Control Group).~   "
252541|NCT00246025|"~     The goal of this study is to evaluate the comparative efficacy and safety of three different~     doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to~     placebo, in prevention of venous thromboembolism in patient with primary elective total knee~     replacement surgery, and to evaluate dose-response.~   "
252542|NCT00246012|"~     The purpose of this study is to evaluate the safety and effectiveness of the intetumumab,~     alone and in combination with dacarbazine, in patients with stage 4 melanoma.~   "
252543|NCT00245986|"~     This study will evaluate the effects of genetics on metabolism of the anti-HIV medicine~     efavirenz (Sustiva) and will see if Efavirenz interacts with bupropion (Zyban or Wellbutrin),~     a drug commonly used to treat depression and to help people quit smoking. Efavirenz is~     metabolized by an enzyme called CYP2B6, which is thought to be more active in some people~     than in others, depending on their genetic makeup. The rate of metabolism of the drug can~     affect how the body responds it and perhaps the ability of the HIV virus to develop~     resistance to it.~      Healthy volunteers between 18 and 55 years of age who are non-smokers and HIV-infected men~     and women 18 years of age and older who are taking efavirenz along with two or three~     nucleoside reverse transcriptase inhibitors may be eligible for this study. Candidates are~     screened with a medical history and physical examination and blood tests, including tests to~     determine which genes they have for four different proteins or enzymes (CYP2B6, CYP3A4,~     CYP3A5, and MDR1) that metabolize drugs.~      Participants are assigned to one of three groups for the following procedures:~      -HIV-infected individuals: Blood samples are drawn to measure efavirenz levels, as follows:~     On the last day of taking efavirenz, the subject skips his or her usual evening efavirenz~     dose the night before sampling. The next morning at clinic, a catheter (flexible plastic~     tube) is inserted into a vein in the subject's arm for collecting blood samples. After the~     first sample is drawn, the subject takes a dose of efavirenz. Eight more blood samples are~     collected at 1, 2, 4, 6, 8, 12, 24 and 48 hours after taking the efavirenz tablet. (The~     catheter is removed after the 12-hour sample and the subject is discharged home, and then~     returns to the clinic for the 24- and 48-hour samples, which are collected through a needle~     inserted into an arm vein.) The subject returns to the clinic four more times for a single~     blood draw at 7, 14, 21 and 28 days after stopping efavirenz.~      HIV-infected patients whose HIV viral load reaches 1,000 copies/L or more within 12 months~     after completing the study are asked to return to the clinic for a blood draw to check the~     genotype of the virus for drug resistance.~        -  Healthy Volunteers - Group 1: Blood samples are drawn to measure efavirenz levels, as~          follows: Participants take one efavirenz tablet once a day for 13 to 15 days. On the~          last day of taking efavirenz, the subject takes his/her last dose of efavirenz in~          clinic, where blood is then collected as described above for HIV-infected individuals.~        -  Healthy Volunteers - Group 2: A catheter is inserted into a vein in the subject's arm~          and a blood sample is drawn through the catheter. The subject then takes a single~          bupropion tablet and additional blood samples are drawn at 1,2, 2.5, 3, 3.5, 4, 6, 8,~          12, 24 and 48 hours after the dose to measure the amount of drug in the blood. Subjects~          begin taking efavirenz 0 to 6 days after the last bupropion blood level is measured. As~          above, subjects will take one efavirenz tablet once a day for 13 to 15 days. On the last~          day of taking efavirenz, a catheter is inserted into the subject's arm. Two blood~          samples are drawn through the catheter, the subject takes the daily dose of efavirenz~          along with a bupropion tablet. Eleven additional blood samples are drawn at 1, 2, 2.5,~          3, 3.5, 4, 6, 8, 12, 24, and 48 hours after taking the pills to measure blood levels of~          bupropion. Eight additional samples are collected at 1, 2, 4, 6, 8, 12, 24, and 48 hours~          to measure efavirenz blood levels. (The catheter is removed after the 12-hour sample and~          the subject is discharged home; the 24- and 48-hour samples are collected through a~          needle inserted into an arm vein.)~   "
252544|NCT00245973|"~     The purpose of the study is to investigate whether eight weeks of treatment with flexible~     doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar~     disorder.~   "
252545|NCT00245960|"~     To assess the efficacy of two different treatment regimens of etanercept in psoriasis~     subjects with psoriatic arthritis with respect to both the skin and joint manifestations.~   "
252546|NCT00245947|"~     Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with~     inflammation associated with active Crohn's disease.~   "
252547|NCT00245934|"~     The purpose of this study is to investigate the incidence of adverse events for patients with~     rheumatoid arthritis treated with Enbrel under usual care settings. In addition, differences~     in injection site reactions based on whether health care professionals or patients administer~     Enbrel will be assessed and evaluated.~   "
252548|NCT00245921|"~     To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a~     combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.~   "
252549|NCT00245908|"~     The ASTHMA Pilot Study is a randomized, controlled, parallel group clinical trial of 6 weekly~     doses of azithromycin (cumulative dose 4800 mg) or placebo as adjunctive treatment in~     addition to usual care for adults with stable persistent asthma, with final follow up at 3~     months after completion of study medication.~      The hypothesis to be tested is that antibiotic treatment will improve asthma at followup, and~     that this improvement will be limited to patients with evidence of C. pneumoniae infection.~      The secondary hypothesis is that randomized, controlled treatment trials can be carried out~     successfully in a geographically dispersed practice-based research network.~   "
252550|NCT00245895|"~     The purpose of this study is to see if darbepoetin alfa is an effective treatment for anemia~     in prostate cancer patients and, if so, what dose is most effective. Sometimes prostate~     cancer patients have low red blood cell counts (low hemoglobin) from various treatments they~     are receiving, such as chemotherapy. The red blood cells deliver oxygen to the tissue. This~     then helps give the patient more energy.~   "
252551|NCT00245882|"~     The purpose of this research study is to compare two different methods of helping veterans~     with diabetes better manage their disease. This study will compare an Active Care~     Management method using home-based technology and self-monitoring techniques with a~     lower-intensity Care Coordination method based on monthly telephone contact with a nurse.~   "
252552|NCT00245869|"~     This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy~     of chemotherapy in breast cancer precise.~      This real-time noninvasive and feasible imaging technique allows us, the investigators at~     University Hospital Tours, to evaluate early vascular changes of breast tumors during~     treatment. These vascular changes may precede long-term tumoral regression. Imaging of~     primary breast lesions may be of value in the prediction of late treatment response.~      An ultrasound will be performed before the initiation, and after the second and the last dose~     of chemotherapy.~      To investigate the changes occurring in the vascularization of tumors, we will use an~     intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles).~      This agent is a microbubbles preparation that is stable, resistant to pressure, and~     specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis.~   "
252553|NCT00245856|"~     The purpose of this study is to document the long-term outcome or prognosis of patients~     diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin~     sodium injection) for three months.~   "
252554|NCT00245843|"~     The purpose of this study is to investigate if the effects of the Vermont intervention,~     implemented by nurses in a Neonatal Intensive Care Unit (NICU), can influence social~     interaction and joint attention skills between parents and preterm babies in the second half~     of the first year of life.~   "
252574|NCT00245583|"~     This study will assess the efficacy of topiramate in the treatment of pathological gambling.~     Pathological gambling (PG) is a debilitating disorder, generally leading to severe personal,~     familial, financial, social, and occupational impairments. In PG, the patient experiences a~     progressive inability to resist impulses to gamble, and gambling significantly disrupt the~     patient's functioning in the personal, familial, and/or vocational spheres. Topiramate has~     shown preliminary evidence of efficacy in some impulse control disorders.~   "
252577|NCT00245544|"~     The purpose of this study is to test the safety and effect of MK0759 in relieving neuropathic~     pain as experienced by patients with postherpetic neuralgia (PHN).~   "
252555|NCT00245830|"~     The long-term goals of this proposal are to develop clinical protocols of donor~     preconditioning to improve liver graft function and ameliorate complications of poor graft~     function after liver transplantation. Achievement of these objectives would improve liver~     recipient outcomes, increase utilization of livers and alleviate the current critical~     shortage of livers for transplantation. More stringent liver donor selection intended to~     decrease the complications of poor graft function conflicts directly with efforts to maximize~     the use of donor livers. Ischemic preconditioning (IPC) of liver attenuates hepatic ischemia~     reperfusion injury (IRI) in animals. Preliminary data show hepatic IPC effectively decreases~     IRI following hepatic resection in humans.~      The specific aims of this project are: AIM 1: To test the hypothesis that 10 minutes of~     hepatic ischemic preconditioning in deceased donors would improve liver graft function and~     decrease injury in the early post transplant period. AIM 2: To test the hypothesis that~     ischemic preconditioning of deceased donor livers would decrease systemic inflammatory~     response in liver recipients in the early post transplant period. AIM 3: To examine whether~     ischemic preconditioning of deceased donor livers decreases early post transplant pulmonary~     edema and acute rejection and shortens hospital stay.~   "
252556|NCT00245817|"~     HINCAB-study is a single senter, prospective, randomised controlled trial. The aim of the~     study is to test the effect of a home based intervention program. The hypothesis of the study~     is that a home based intervention will influencing coping strategies in the CABG-patients~     rehabilitation phase, reduce symptoms and improve health related quality of life.~   "
252557|NCT00245804|"~     Developmental dyslexia is a frequent learning disability. The aim of this study is to compare~     auditory evoked cortical responses to syllables and tones in developmental dyslexia and~     controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10~     years ; 11-17 years and 18-25 years. We suppose that cortical responses should be different~     in developmental dyslexia and controls.~   "
252558|NCT00245791|"~     The purpose of the study is to compare the safety and effectiveness of the antibiotic~     levofloxacin by administering a higher dose of levofloxacin and using a shorter course of~     therapy.~   "
252559|NCT00245778|"~     The aim of the study is to localise brain regions involved in objects recognition, in~     planification and adjustment of grasping, in prehension with and without eye control. The~     study is conducted in normal and autistic adults. We hypothesize different activations in~     these two populations.~   "
252560|NCT00245765|"~     A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo,~     administered during 12 weeks, to patients suffering from moderate to severe chronic plaque~     psoriasis, extended by a 12 to 24 week follow-up.~   "
252561|NCT00245752|"~     The purpose of the study is to evaluate whether acupuncture can be used to ripen cervix~     before medicinal induction of labor or even be used as method for induction, and thereby~     eliminating other and more potentially harmful methods.~   "
252562|NCT00245739|"~     The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for~     HIV-1 infected patients with limited or no treatment options, who have failed multiple~     antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of~     TMC114/r in combination with other antiretrovirals~   "
252563|NCT00245726|"~     The overall objective of this research project is to examine the clinical efficacy of lower~     extremity cycling with functional electrical stimulation to improve the health and fitness of~     children with spinal cord injuries (SCI). To achieve this goal, a controlled, randomized~     study will be conducted with thirty children who have sustained a spinal cord injury. The~     children in the study will be assigned to one of three groups: those receiving functional~     electrical stimulation (FES) leg cycling exercise, those receiving passive leg cycling, and a~     non-cycling control group receiving electrical stimulation therapy to generate muscle~     contractions in the lower extremity. All three groups will be balanced as to the amount of~     time they receive the specific therapy. All therapies, after initial assessment, will be~     conducted at home in order to foster changes in lifestyle that may prove to be essential for~     improved quality of life.~      The specific aims of this proposal are delineated below:~      Aim 1: To assess, by means of a randomized controlled study design, the ability of FES~     cycling to improve the cardiovascular and musculoskeletal systems of ten children with a~     spinal cord injury, as compared to ten children undergoing passive leg cycling exercise and~     ten children receiving electrical stimulation therapy alone.~      Aim 2: To determine, by means of a randomized controlled study design, the feasibility of~     using FES leg cycling exercise to provide long-term health benefits and improve the~     neurologic status of ten children with a spinal cord injury, as compared to ten children~     undergoing passive leg cycling exercise and ten children receiving electrical stimulation~     therapy alone.~   "
252564|NCT00245713|"~     Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy~     receiving a classical antiepileptic drug~   "
252565|NCT00245700|"~     To test if combining two antiparkinson drugs into a single tablet improves accuracy of~     medicine intake by the patient.~      To test if patients with Parkinson's disease who take medicines at regular time intervals~     have smoother symptom control.~   "
252566|NCT00245687|"~     The purpose of this study is to compare the success rates of two types of feeding tubes,~     specifically the standard gastric feeding tube to a small bowel feeding tube.~   "
252567|NCT00245674|"~     During this study the efficacy and safety profile will be evaluated of the use of amisulpride~     in the form of a solution in schizophrenic patients with an acute episode.~      The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a~     solution during the first days of an acute episode of schizophrenia.~   "
252568|NCT00245661|"~     The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime~     on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary~     disease.~      The study hypothesis is that temazepam does not produce any adverse respiratory effects~     during sleep in patients with COPD. In contrast, it may result in an beneficiary effect~     because it positively affects the sleep quality and sleep structure which may result in more~     alertness and less daytime sleepiness and less dyspnea during the day.~   "
252569|NCT00245648|"~     This study evaluated differences between men and women in the presentation, management and~     outcome of heart attacks within the GUSTO V study.~   "
252579|NCT00245518|"~     This study will look at the effects of a soy supplement called Revival on memory, quality of~     life, and hot flashes in men with prostate cancer who are being treated with testosterone~     suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will~     result in at least a 50% reduction in hot flashes compared to placebo.~   "
252580|NCT00245505|"~     The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa~     Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy.~   "
252581|NCT00245492|"~     The proposed research aims to determine the prevalence, size, shape and histology of flat~     colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for~     screening colonoscopy. Patients will be randomized to either conventional colonoscopy or~     chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined~     in the usual manner. The primary outcome will be the total number of adenomas detected, with~     special attention to the subgroup of flat and depressed lesions. To promote the~     generalizability of the results, neoplasms will be described according to standard Western~     and Japanese classification schemes.~   "
252582|NCT00245479|"~     To evaluate the overall response to desmopressin treatment among previously untreated~     enuretic children aged 5-15 years after 3 and 6 months of treatment.~      To investigate the influence of possible predictive factors on response after 3 and 6 months~     of treatment.~      To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety~     profile of oral desmopressin in children with primary nocturnal enuresis.~   "
252583|NCT00245466|"~     To investigate the long-term safety and tolerability of repeated doses of degarelix to~     prostate cancer patients~   "
252584|NCT00245453|"~     To measure the speed of bacterial eradication from the respiratory tract after administration~     of azithromycin or telithromycin.~   "
252585|NCT00245440|"~     The purpose of this study is to measure the speed of microbial eradication due to~     azithromycin or telithromycin in acute maxillary sinusitis (AMS).~   "
252586|NCT00245427|"~     A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide~     antibiotics in the community~   "
252587|NCT00245414|"~     The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for~     subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis~     C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high~     viral load (≥ 100 KIU/mL).~      In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c.~     injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic~     hepatitis C patients.~   "
252588|NCT00245401|"~     The purpose of this PMS registry, named e-CYPHER Stent Registry, is to collect post marketing~     surveillance data on the CYPHERTM Sirolimus-eluting Coronary Stent following marketing~     approval, when used in normal clinical practice within the labeled indications.~   "
252589|NCT00245388|"~     This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the~     lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with~     pravastatin in subjects with mixed dyslipidemia.~   "
252590|NCT00245375|"~     Increasingly in general surgery, the investigators are conducting outpatient day surgery.~     Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America.~     These patients all require some form of analgesia which can be taken at home in the first few~     days after the surgery. The current standard at the investigators' centre and many others in~     the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or~     oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as~     oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication~     (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects,~     and may not provide effective pain relief. In the investigators' experience, non-steroidal~     anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic~     regimen.~      Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain~     medication. They hope to show that a combination of ibuprofen and acetaminophen is better for~     pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a~     safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of~     surgeons are old habits, it will require a very convincing argument to get them to change~     their practices. A randomized controlled trial comparing these two regimens, the~     investigators hope, would be a powerful enough argument.~      The hypothesis of this study, therefore, is that the pain control provided by a combination~     of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to~     Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day).~      This study will attempt to enroll 150 patients in total. Eligible patients will be identified~     by their attending surgeon and contacted by study personnel. Patients who enroll in the study~     will undergo their surgery in the usual manner. After the surgery, in the recovery room, once~     they are ready to go home, they will be randomized to receive combination A or B and be given~     a week's worth of pain medication. They will then go home and take this medication as~     directed. They will record their pain intensity and pain relief once per day using a diary~     provided in the study package. One week after their surgery, they will return to the hospital~     clinic and be seen by the study nurse. They will hand over the diary and any unused~     medication. They will also be asked several questions regarding their overall satisfaction,~     incidence of side effects, and how long until they were pain free.~      The risks of participating in this study are minimal from the risks inherent to the~     procedures and medications the patients would receive within the standard of care. Ibuprofen~     is a commonly used NSAID which is widely available over the counter and has an established~     safety profile. The most common adverse effects of ibuprofen and other NSAIDs are~     gastrointestinal bleeding and ulceration. Other less common adverse effects include~     nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive~     dysfunction. The investigators' patients will be selected to exclude those most at risk for~     these complications (see exclusion criteria). Acetaminophen has few side effects, with no~     adverse effects on platelet function and no evidence of gastric irritation.~   "
252591|NCT00245362|"~     To evaluate the safety and effectiveness of CG8020 and CG2505.~   "
252592|NCT00245349|"~     Preliminary observations suggest positron emission tomography (PET) imaging with an F-18~     labeled thymidine analog (FLT) can selectively identify proliferating and non-proliferating~     tissues, including tumors. FLT uptake in the tumor appears to reflect the level of cells~     undergoing DNA synthesis. This is clinically important because cell proliferation markers~     have significant prognostic value, both prior to initiating radiotherapy and as they change~     during the course of therapy. In the proposed study, the researchers assess the~     biodistribution and radiation dosimetry of FLT to obtain the necessary data to file an~     Investigational New Drug (IND) application with the Food and Drug Administration (FDA). The~     information collected under Radioactive Drug Research Committee (RDRC) approval will not be~     used for diagnostic purposes, to assess the subject's response to therapy, or for clinical~     management of the subject.~   "
252593|NCT00245336|"~     The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is~     effective in stopping bleeding during surgery, in comparison with bovine thrombin.~   "
252594|NCT00245323|"~     The purpose of this study is to determine if checking smoking status as a routine vital sign~     increases the delivery rate of cessation counseling to adult smokers in primary care~     practices.~   "
252595|NCT00245310|"~     Indocyangreen (ICG)is totally biliary eliminated and corresponds to hepatocyte function and~     liver perfusion.~      The ICG-clearance will be evaluated as a prognostic marker in liver disease.~   "
252596|NCT00245297|"~     Primary efficacy endpoint: To study whether there is a difference in the length of the~     bleeding free periods between infusion of FVIII that is reconstituted with 22.1, 12.6, or 4.2~     mg of pegylated liposomes per kg bwt compared with standard formulation.~      Safety endpoint: To study the safety and tolerability of Kogenate FS reconstituted with~     Pegylated liposomes~   "
252597|NCT00245284|"~     Evaluation of skin cholesterol for cardiovascular risk assessment in asymptomatic individuals~     at low, intermediate, or high risk based on Framingham Global Risk estimates. Carotid~     intima-media thickness (IMT), a surrogate marker for atherosclerotic burden, that~     independently predicts the occurrence of heart attack and stroke, will be the “gold standard”~     comparator.~      Hypothesis: Skin cholesterol, as measured by two non-invasive tests, correlates with CAD, as~     measured by CIMT in this population.~   "
252598|NCT00245271|"~     OMS103HP is being developed for improvement in knee function following ACL reconstruction.~     Secondary benefits being evaluated include reduced postoperative pain, improvement in knee~     motion and earlier return to work.~   "
252599|NCT00245258|"~     The study objective is to:~        1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the~          end of the double-blind phase~        2. To assess the relationship between treatment with sildenafil citrate or placebo and~          responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience~          Questionnaire (SEX_Q).~   "
252627|NCT00244894|"~     RATIONALE: Acupuncture may help relieve hot flashes in patients with prostate cancer.~      PURPOSE: This clinical trial is studying how well acupuncture works in treating hot flashes~     in patients with prostate cancer who are undergoing androgen deprivation.~   "
252600|NCT00245245|"~     The ability of a new recombinant porcine coagulation factor VIII, B-domain deleted (called~     OBI-1), to control the non-life- or limb-threatening bleeding episodes patients with~     hemophilia A commonly develop is being evaluated. Patients with congenital hemophilia A and a~     low-titer (<20 Bethesda units [Bu]) inhibitory antibody to OBI-1, who meet the~     inclusion/exclusion criteria, will receive OBI-1 to treat their soft tissue or joint bleeding~     episode. At least the first two treatment episodes will be performed in the controlled~     setting of the hemophilia center/clinic/office, where any side effects can be observed. If~     the patient continues to meet the inclusion/exclusion criteria, has had no serious or severe~     adverse reactions to OBI-1, and has been in a home care program, the investigator may permit~     the patient to self-administer OBI-1 at home to treat subsequent bleeding episodes. The study~     will continue at least until 12 or more patients have received at least 24 treatment episodes~     in the aggregate.~   "
252601|NCT00245232|"~     This study will evaluate the effectiveness of cognitive processing therapy versus its~     individual components in treating women with post-traumatic stress disorder (PTSD) and~     depression brought on by sexual assault.~   "
252602|NCT00245219|"~     The present study sought to investigate the efficacy of two psychosocial interventions for~     breast cancer patients, a peer support intervention and an education intervention. The~     present study also sought to identify mechanisms underlying the benefits of these~     interventions, and to determine if the efficacy of these interventions is moderated by cancer~     severity.~   "
252603|NCT00245206|"~     This study will compare four atypical antipsychotic medications in terms of the risk of~     specific side effects each of them presents in middle-aged and elderly individuals.~   "
252604|NCT00245193|"~     This study will investigate the effectiveness of motivationally-enhanced brief interpersonal~     psychotherapy (MI-IPT-B) in treating depression in mothers who bring their children to a~     child mental health clinic for psychiatric treatment.~   "
252605|NCT00245180|"~     The purpose of this study is to establish an intervention to keep American Indian/Alaskan~     Native (AI/AN) children from becoming overweight.~   "
252606|NCT00245167|"~     The first objective of this study is to determine if increased expression of one or more~     members of the toll-like receptor (TLR) family of receptors that are found on inflammatory~     cells (present in the airway) precede development of chronic lung disease (CLD) of~     prematurity. The study will also determine if there is a significant correlation between TLRs~     and the severity of CLD. The second objective of this study is to determine the impact of~     c-administration of inhaled nitric oxide (INO) on TLR expression in infants at risk of~     developing CLD or with early CLD.~   "
252607|NCT00245154|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Cediranib maleate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel and~     carboplatin together with AZD2171 may kill more tumor cells. It is not yet known whether~     giving paclitaxel and carboplatin together with AZD2171 is more effective than giving~     paclitaxel and carboplatin together with a placebo in treating non-small cell lung cancer.~      PURPOSE: This randomized phase II/III trial is studying how well giving paclitaxel and~     carboplatin together with cediranib maleate works and compares it to giving paclitaxel and~     carboplatin together with placebo in treating patients with stage III or stage IV non-small~     cell lung cancer.~   "
252608|NCT00245141|"~     RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to~     kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and~     cyclophosphamide together with or without radiation therapy works in treating patients with~     embryonal rhabdomyosarcoma.~   "
252609|NCT00245128|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well~     it works in treating patients with myelofibrosis.~   "
252610|NCT00245115|"~     RATIONALE: Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs,~     helps stem cells move from the bone marrow to the blood so they can be collected. Treating~     stem cells collected from the patient's blood or bone marrow with chemotherapy in the~     laboratory removes any remaining cancer cells. Chemotherapy or radiation therapy is given to~     the patient to prepare the bone marrow for stem cell transplant. The treated stem cells are~     then returned to the patient to replace the blood-forming cells that were destroyed by the~     chemotherapy.~      PURPOSE: This clinical trial is studying how well an autologous peripheral stem cell or bone~     marrow transplant using laboratory-treated cells works in treating patients with acute~     leukemia.~   "
252611|NCT00245102|"~     This phase II trial is studying how well sorafenib works in treating patients with~     metastatic, locally advanced, or recurrent sarcoma. Sorafenib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to~     the tumor.~   "
252612|NCT00245089|"~     RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and~     cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma.~   "
252613|NCT00245076|"~     RATIONALE: Stop-smoking information on the smokefree.gov website may help people quit smoking~     and remain a nonsmoker.~      PURPOSE: This clinical trial is studying how well the smokefree.gov website works with an~     electronic bulletin board in helping United States federal employees quit smoking.~   "
252614|NCT00245063|"~     This phase II trial is studying how well AZD2171 works in treating patients with recurrent~     small cell lung cancer. AZD2171 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
252615|NCT00245050|"~     RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by~     chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in~     preventing hand-foot syndrome.~      PURPOSE: This randomized clinical trial is studying pyridoxine to see how well it works~     compared to a placebo in preventing hand-foot syndrome in patients who are receiving~     liposomal doxorubicin for recurrent ovarian, fallopian tube, or peritoneal cancer, metastatic~     breast cancer, or advanced endometrial cancer.~   "
252616|NCT00245037|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor~     peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops~     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune system and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte~     infusion) after the transplant may help increase this effect. Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.~      PURPOSE: This phase I/II trial is studying the side effects of giving busulfan and~     fludarabine together with total-body irradiation and to see how well they work in treating~     patients who are undergoing a donor stem cell transplant for hematologic cancer.~   "
252617|NCT00245024|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of sulindac may prevent breast cancer.~      PURPOSE: This randomized phase I trial is studying the effects of sulindac, to prevent breast~     cancer, in women at high risk for breast cancer.~   "
252618|NCT00245011|"~     RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry~     radiation directly to tumor cells and not harm normal cells. A peripheral stem cell~     transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and~     samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem~     cell transplant and radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam~     pentasodium together with autologous stem cell transplant and radiation therapy works in~     treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.~   "
252619|NCT00244998|"~     RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using~     fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.~      PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with~     advanced prostate cancer.~   "
252620|NCT00244985|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. Giving rituximab together with~     liposomal doxorubicin may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with~     liposomal doxorubicin and to see how well they work in treating patients with relapsed or~     refractory B-cell non-Hodgkin's lymphoma.~   "
252621|NCT00244972|"~     This phase I trial studies the side effects and best dose of tipifarnib when given together~     with sorafenib tosylate in treating patients with biopsiable cancer that has spread to other~     places in the body and usually cannot be cured or controlled with treatment. Tipifarnib and~     sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the cancer.~   "
252622|NCT00244959|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.~      PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who~     have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast~     cancer.~   "
252623|NCT00244946|"~     RATIONALE: Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and~     melphalan work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more cancer cells. A peripheral stem cell transplant may be able to replace~     blood-forming cells that were destroyed by chemotherapy. Giving white blood cells, that have~     been treated in the laboratory with antibodies, may make the transplant work better. Giving~     combination chemotherapy followed by an autologous stem cell transplant, and white blood cell~     infusions may be an effective treatment for non-Hodgkin's lymphoma.~      PURPOSE: This phase I trial is studying the side effects and best dose of white blood cell~     infusions when given together with combination chemotherapy, and autologous stem cell~     transplant in treating patients with non-Hodgkin's lymphoma that has relapsed, is refractory,~     or is in remission.~   "
252624|NCT00244933|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together~     with genistein works in treating women with stage IV breast cancer.~   "
252625|NCT00244920|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide~     and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may~     stop the growth of prostate cancer by blocking blood flow to the tumor. Giving hormone~     therapy together with squalamine lactate before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~      PURPOSE: This randomized phase II trial is studying how well giving hormone therapy together~     with squalamine lactate works compared to hormone therapy alone in treating patients who are~     undergoing a radical prostatectomy for locally advanced prostate cancer.~   "
252626|NCT00244907|"~     Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause,~     estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly~     osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide~     protection against bone loss. This study will evaluate the effect of soy isoflavones on~     calcium absorption and bone loss in post menopausal women.~   "
252628|NCT00244881|"~     AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial~     is studying how well AZD2171 works in treating patients with refractory stage IV breast~     cancer~   "
252629|NCT00244868|"~     RATIONALE: A computer-based survey and communication aid may help physicians and patients to~     communicate better and help make treatment decisions easier.~      PURPOSE: This phase III randomized clinical trial is studying how well giving a~     computer-based survey together with a communication aid works compared to a computer-based~     survey alone in improving physician-patient communication and treatment decision making in~     patients with metastatic cancer.~   "
252630|NCT00244855|"~     This phase II trial studies the side effects and how well giving rituximab and dexamethasone~     together works in treating patients with low-grade non-Hodgkin lymphoma (NHL). Monoclonal~     antibodies, such as rituximab, can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     carry cancer-killing substances to them. Drugs used in chemotherapy, such as dexamethasone,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving rituximab together with dexamethasone may kill more~     cancer cells~   "
252631|NCT00244842|"~     The purpose of this study is to determine which dose of voclosporin is effective in the~     treatment of plaque psoriasis compared to placebo.~   "
252632|NCT00244829|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant~     may prevent the recurrence of Philadelphia chromosome-positive leukemia.~      PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after~     a donor stem cell transplant and to see how well it works in treating patients with~     Philadelphia chromosome-positive leukemia.~   "
252633|NCT00244816|"~     To evaluate objective response rate and duration of response to weekly Taxoprexin®.~      To evaluate the safety profile of weekly Taxoprexin® in this patient population.~      To evaluate overall survival in the same patient population. To evaluate time to disease~     progression, and the time to treatment failure in patients with metastatic choroidal melanoma~     being treated with weekly Taxoprexin® Injection.~   "
252634|NCT00244803|"~     The purpose of this study is to learn whether HIV-infected patients have blood abnormalities~     which could lead to heart attack or stroke, and to find out what factors may contribute to~     these abnormalities.~   "
252635|NCT00244790|"~     The purpose of this study is to determine if being overweight and eating lots of protein~     causes separate changes in the kidney that lead to kidney disease over time. These questions~     are important because the number of people who have kidney disease is quickly growing. If~     being overweight and eating lots of protein is found to cause kidney disease, then doctors~     may be able to limit the number of people with kidney disease by recommending weight loss and~     eating less protein~   "
252636|NCT00244777|"~     The World Health Organization has very recently recommended the routine use of a hypo-osmolar~     ORS in the management of diarrhoeal diseases. This recommendation is based on the better~     efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled~     clinical trials. The recommendation, however, also expressed the need for careful monitoring~     to better assess risk, if any, of symptomatic hyponatraemia. There thus is a need for phase~     IV trials before the new solution is introduced into routine clinical practice to assess the~     risk in relatively large number of patient populations. The proposed study will be carried~     out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients)~     and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The~     hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients~     with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L.~     Surveillance will be carried out to detect adverse events focusing on the occurrence of~     seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy~     would be evaluated to determine if they are associated with abnormal levels of serum sodium~     or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially~     admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab~     Hospital might require admission to the longer stay inpatient wards due to seizure or altered~     consciousness. Such patients would be thoroughly assessed including determination of their~     serum sodium and glucose, two common causes of seizures/altered consciousness, to determine~     if and to what extent they could be attributed to hyponatraemia.The results from this study~     would be used in planning and implementing the routine use of the new formulation of ORS at~     all Government, NGO and private health care facilities that treat diarrhoeal patients, in~     Bangladesh and in other countries.~   "
252637|NCT00244764|"~     Phase II, multi-center, two-stage study utilising a randomised discontinuation design to~     evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally~     recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis,~     the design was changed to an open label, single arm study with all subjects receiving~     pazopanib.~   "
252638|NCT00244751|"~     The purpose of this study is to examine the safety and effectiveness of GI262570 compared to~     placebo (a pill that looks exactly like GI262570 but contains no active medicine) in~     improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who~     are enrolled in the study must have had prior treatment with interferon (either pegylated or~     standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but~     either failed to clear the virus or didn't tolerate the treatment.~   "
252639|NCT00244738|"~     The purpose of the study is to determine whether castor oil is effective in inducing labor.~   "
252640|NCT00244725|"~     Odiparcil is being studied to determine if it can prevent blood clots from forming after a~     total knee replacement and also to prove that odiparcil is safe.~   "
252641|NCT00244712|"~     This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine)~     and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used~     in combination with KALETRA (lopinavir/ritonavir) over 96 weeks~   "
252650|NCT00244595|"~     The objectives of this study are to describe candesartan cilexetil antihypertensive effects~     in terms of achieved blood pressure and hypertension control rates and the relationship~     between subject characteristics and antihypertensive efficacy, and between antihypertensive~     therapy (candesartan cilexetil dose and add-on treatments) and efficacy over a 1 year~     treatment period in hypertensive children ages 6 to < 17 years; to describe growth in terms~     of height and weight in the study population; to describe change in neurocognition as~     assessed by the Full Scaled IQ score in a subset of study subjects; to determine the~     pharmacokinetics of candesartan in hypertensive paediatric subjects ages 6 to < 17 years; and~     to describe safety including adverse events and adverse events necessitating study drug~     discontinuation including dose level and dose duration relationships and growth over a 1 year~     period in hypertensive children age 6 to < 17 years.~   "
252651|NCT00244582|"~     This study will use an experimental method of delivering the enzyme glucocerebrosidase~     directly into the brain of a patient with Gaucher disease to treat disease symptoms. Patients~     with Gaucher disease have insufficient levels of glucocerebrosidase. As a result, substances~     normally broken down by this enzyme accumulate in the body, causing damage to the brain and~     other organs. Symptoms of Gaucher disease outside the brain can be treated by infusing the~     missing enzyme intravenously (IV, through a vein). However, IV infusions do not help the~     neurologic symptoms of the disease, because the enzyme cannot get into the brain. This study~     will use a new technique called convection-enhanced delivery to try to introduce~     glucocerebrosidase directly into the brain.~      This single-patient study includes an 8-month-old male with Type 2 Gaucher disease with~     progressive neurological decline.~      In preparation for the enzyme infusion, the patient will have a complete physical~     examination, including a detailed neurological examination, and blood and urine tests. On the~     day of surgery, the child will be placed under general anesthesia for magnetic resonance~     imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to produce images of~     body tissues and organs. For this procedure, the child lies on a table that is moved into the~     scanner (a narrow cylinder), wearing earplugs to protect his hearing from the loud knocking~     and thumping sounds that occur during the scanning process. He will then be brought to the~     operating room for the infusion procedure, as follows:~      An incision will be made in the scalp and a small hole drilled through the skull. Then, a~     small tube (cannula) will be positioned through the hole into the target area in the brain.~     Once the tip of the cannula is in place, it will be connected with tubing to a syringe filled~     with glucocerebrosidase in saline (salt water). The child will then have a second MRI scan to~     make sure the cannula is placed correctly and to monitor delivery of the glucocerebrosidase~     to the brain. The child will be monitored closely with MRI scans every 30 to 60 minutes~     during the infusion to look for fluid in the brain and determine the extent of the enzyme~     perfusion. The infusion will last no longer than 6 hours and will be stopped when the full~     dose of enzyme has been delivered. The cannula will be removed and the scalp incision closed.~     The child will stay in the hospital for observation from 4 to 10 days, with at least 24 hours~     in the intensive care unit and 3 to 7 days in the pediatric unit.~      The child will be seen in the clinic two weeks after discharge and then once a month for 3~     months to evaluate any possible effects of the surgery. These follow-up visits include a~     repeat MRI scan and neurological examination. After the first 3 months, visits may be less~     frequent.~      If the child continues to have symptoms during the course of follow-up or his neurologic~     status worsens, additional enzyme infusions will be offered, possibly including treatment of~     the brainstem. If the child gains no benefit after three infusions have been performed, no~     additional infusions will be offered. If there appears to be any neurological benefit,~     additional infusions may be offered.~   "
252642|NCT00244699|"~     The proposed study will evaluate the clinical effectiveness of integrating mindfulness-based~     skills training into a standardized brief group intervention for youth (ages 16 to 24)~     identified as having problematic substance use. Forty youth (N = 20 per group) will be~     randomized to one of two treatment conditions: 1) a standardized 4-week brief treatment for~     problematic substance use (treatment as usual; TAU) or 2) standardized brief treatment (TAU)~     augmented with a mindfulness skills training component based primarily on the mindfulness~     module described in Linehan's (1993b) Dialectical Behavior Therapy skills group training. It~     is expected that, compared to the TAU, the mindfulness-based group plus TAU will produce~     superior outcomes on the following primary outcome measures: number of substance use days,~     confidence to resist urges to use substances, and mindfulness skills. Secondary outcomes that~     will be examined include severity of consequences of use, general psychiatric symptoms,~     self-compassion, emotion dysregulation, and transfer to further treatment.~   "
252643|NCT00244686|"~     104317: The market authorisation application for mepolizumab for the indication of~     hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to~     outstanding questions from regulator's raised from the application. On the basis of sponsor's~     evaluation, participants with life-threatening HES who have documented failure (lack of~     efficacy or a contra-indication) to at least 3 standard HES therapies (compassionate use) and~     participants who have participated in a previous GSK sponsored study in HES (long-term~     access) can be consider for mepolizumab treatment where the country regulation permits. In~     this study, participants will receive mepolizumab in an open-labelled manner, and limited~     data will be collected to evaluate the long-term safety and efficacy of mepolizumab.~      201956: This is a Long-term Access Programme (LAP) which aims to support provision of~     mepolizumab, until it is commercially available, to eligible subjects with severe asthma who~     participated in a GSK-sponsored mepolizumab clinical study in severe asthma. Eligible~     subjects will initiate mepolizumab within a 6-month period following the individual subject's~     last scheduled visit in their preceding clinical study. For each subject benefit versus risk~     will be assessed throughout the study to support continued treatment with mepolizumab.~      112562: To provide a mechanism for expanded access to mepolizumab therapy for eligible~     patients with HES. Whenever possible, use of an investigational medicinal product by a~     patient as part of a clinical trial is preferable. However, when patient enrollment in a~     clinical trial is not possible (such as when the patient is not eligible for ongoing clinical~     trials or the patient is not able to attend investigational sites), appropriate patients may~     receive mepolizumab through expanded access. This expanded access protocol was designed to~     allow access to mepolizumab for HES patients with seriously debilitating or life-threatening~     disease that are not able to enroll in clinical trials, including those patients that have~     already participated in a mepolizumab clinical trial.~   "
252644|NCT00244673|"~     In non-randomized studies, routine childhood vaccinations have been observed to have~     non-targeted effects. Difteria-tetanus-pertussis (DTP) vaccine provided with or after measles~     vaccine (MV) is associated with increased mortality in areas with herd immunity to pertussis.~      We will examine in a randomised study of 6000 children the effect of not administering DTP~     simultaneously with or after MV on overall child mortality, hospitalization rates, and the~     immunological responses after vaccination. We will also examine potential sex-differential~     effects in the outcomes and interactions with other vaccines, other health interventions and~     season.~   "
252645|NCT00244660|"~     To investigate the effect on blood pressure (BP) control in hypertensive patients using a~     combination of frequent home - and 24-h ambulatory blood pressure measurement (ABPM) in a~     Danish general practice (GP) setting.~   "
252646|NCT00244647|"~     The process of re-narrowing of a coronary artery following a revascularization procedure such~     as angioplasty, begins at the time of the procedure. Restenosis has long been considered a~     major problem for effective long-term interventional success. This often results in repeated~     procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel.~      There is a substantial body of literature suggesting that local MYC protein production in the~     injured coronary artery is a major stimulus and potential cause of restenosis that appears~     after stent placement. This study is based upon the hypothesis that stopping MYC protein~     production in the vessel has will help reduce restenosis (vessel re-narrowing).~      AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that~     interferes with MYC production.~      This study will evaluate the safety, pharmacokinetics and potential effectiveness of a single~     intravenous slow-push dose of RESTEN-MP at the time of stent placement to reduce in-stent~     restenosis following balloon angioplasty and stent placement. The post-dose follow-up period~     is up to six-months.~   "
252647|NCT00244634|"~     Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a~     multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study with a 4 week treatment period in hypertensive pediatric subjects.~      Subjects undergo a screening evaluation, then a 1-week, single-blind, placebo run-in after~     which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil~     or placebo. The study includes 2 panels based on subject weight.~      The primary efficacy analysis is based on the intent-to-treat population and tests for slope~     = 0 in a linear regression model with change in sitting systolic blood pressure as the~     dependent and non-zero dose pooled across weight panels as the independent variable. For~     subjects without a Double-Blind Week 4 blood pressure determination, carrying the last value~     forward assigns the value.~      Additional analyses will include data pooled from a similar dose ranging study conducted in~     children 1 to < 6 years of age.~   "
252648|NCT00244621|"~     This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages~     1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design~     intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo~     run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment~     period. Subjects undergo a screening evaluation, then a 1-week single-blind, placebo run-in,~     after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan~     cilexetil (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio~     for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment~     will be performed and subjects may begin the 52-week, open-label treatment period of the~     study.~   "
252649|NCT00244608|"~     The purpose of this study is to determine if a flexible dose of Symbicort has a similar~     effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with~     additional glucocorticosteroids added.~   "
252652|NCT00244569|"~     The purpose of this study is to determine the safety and efficacy of the Oridion Breath ID~     machine in monitoring liver metabolic functions.~   "
252653|NCT00244556|"~     To investigate the changes in MRI-derived markers of joint inflammation and destruction and~     in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid~     arthritis patients treated with Enbrel and Enbrel+methotrexate.~   "
252655|NCT00244530|"~     To compare renal function (51Cr-EDTA clearance) 48 hours post open-heart surgery (coronary~     bypass or valve surgery) in patients with impaired renal function after randomization to~     either nifedipine infusion at start of surgery and the following 24 hours or placebo (0.9%~     saline infusion). Study hypothesis is that nifedipine has a prophylactic effect on decline in~     renal function.~   "
252656|NCT00244517|"~     Anaesthetics may impair the diastolic function of the heart, but the importance of this~     finding for patients has not been sufficiently examined. Specially the effects on diastolic~     function in patients with diastolic dysfunction has to be determined. The aim of this study~     is to examine the effect of isoflurane (only part I), sevoflurane and desflurane (part I+II)~     on the diastolic left ventricular function by doppler echocardiography.~   "
252657|NCT00244504|"~     Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion,~     patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day~     before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery.~     Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up~     interviews at 6 and 12 months~   "
252658|NCT00244491|"~     This intervention tests whether encouraging older patients and their caregivers to assert a~     more active role in their care transitions could improve clinical outcomes. Patients are~     supported by a nurse transition coach and specific tools, including a Personal Health Record.~   "
252659|NCT00244478|"~     This is a 16-week intervention to determine the efficacy of an isoflavone-rich soy based meal~     supplement to improve bone health and prevent weight and fat gain in 18-19 year old college~     females. The primary hypothesis is that participants who receive soy will have favorable~     changes in blood markers of bone and less weight and fat gain. The soy is provided by~     Physicians Pharmaceuticals, Inc. (Revival Doctor-formulated soy protein).~   "
252660|NCT00244465|"~     Patients will be followed up for max 18 months. Information on the Adverse Events and~     potential misuse or abuse of Xyrem ® will be collected.~   "
252661|NCT00244452|"~     Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis,~     describe dose effect relationship and duration of symptom relief~   "
252662|NCT00244439|"~     Current treatments for head lice include over-the-counter products such as permethrin and~     prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a~     novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice.~     The current study will compare the efficacy and safety of this novel formulation of malathion~     with OVIDE and with an over-the-counter permethrin product.~   "
252663|NCT00244426|"~     Evaluate efficacy and safety of Indobufen v. Aspirin in preventing thromboembolic events in~     patients at high risk of CV events such as patients suffering from nonrheumatic atrial~     fibrillation.~   "
252664|NCT00244413|"~     Nondystrophic myotonias (NDM) are muscle disorders caused by genetic abnormalities in certain~     muscle cell membrane proteins. Individuals with NDM experience limited muscle relaxation,~     which causes pain, weakness, and impaired physical activity. The purpose of this study is to~     better characterize the clinical features and symptoms of NDM.~   "
252665|NCT00244400|"~     The purpose of the present study was to examine the possible association of hepatic CYP3A~     activity and the susceptibility to femur head necrosis in patients treated with~     corticosteroids.~   "
252666|NCT00244387|"~     Male and female patients aged ≥ 30 years with advanced stage idiopathic Parkinson's disease,~     not well controlled on existing levodopa will take part in a research study at approximately~     82 sites in Europe, Israel, South Africa, Australia and new Zealand.~      The purpose of the study is to evaluate the effectiveness, safety and tolerability of the~     rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months~      Each patient who qualifies and chooses to participate in the study will receive either~     rotigotine, pramipexole, or placebo at gradually increasing doses over a period of up to 7~     weeks, and then maintain their optimal dose for 4 months.~      The study clinic visits will include a medical history and physical exam, ECG, blood and~     urine sample collection, completion of various questionnaires, and completion of a diary to~     record the severity of their Parkinson's symptoms.~      Patients who complete the study may enroll in an extension trial and receive active study~     drug.~   "
252667|NCT00244374|"~     The purpose of this study is to compare the effects of (a) immunization setting and (b)~     outreach worker support on young injection drug users' (IDU) adherence to a multiple dose~     immunization schedule with a combined hepatitis A virus (HAV) inactivated and hepatitis B~     virus (HBV) recombinant vaccine.~   "
252668|NCT00244361|"~     The purpose of this study is to reduce the symptoms of OMS by testing rituximab (Rituxan®),~     to remove B lymphocytes that make antibodies and trigger brain inflammation. Evidence~     suggests that autoimmune brain inflammation causes the symptoms of OMS. This study of blood~     and spinal fluid intends to find out what effect rituximab has on OMS and on the spinal fluid~     B-cells.~      Rituximab targets and destroys B-cells, which make antibodies that can attack the brain and~     cause may OMS. It is infused through a vein over a period of several hours. Rituximab has~     been used widely and studied extensively since its approval in 1997 by the U.S. Food and Drug~     Administration (FDA) for non-Hodgkin's B-cell Lymphoma (NHL). Today, more than 300,000~     patients have received rituximab, and it is part of more than 200 completed, ongoing, or~     planned clinical trials. Rituximab is not FDA-approved for OMS.~   "
252669|NCT00244348|"~     Hepatic artery infusion (HAI) with oxaliplatin (OX), systemic 5 fluorouracil (5FU), and~     leucovorin (HAI/OX/FU) will be implemented using an interventional radiology technique to~     obviate the need for initial major surgery (catheter placement) in patients who have~     unresectable liver metastasis from colorectal cancer. The study goal is to reduce tumor size~     to make possible a complete resection of all lesions. Secondary goals are to reduce or~     eliminate the complexity usually associated with HAI, to accomplish most or all of the~     treatment as an outpatient, to reduce costs, and to avoid the hepatotoxicity associated with~     HAI/floxuridine (FUDR). Oxaliplatin has been selected because of its ease of use, known~     toxicology, and established efficacy in colorectal cancer.~   "
252670|NCT00244335|"~     Post-traumatic stress disorder (PTSD) is a serious illness, in which individuals often~     experience anxiety and stress. Some individuals with PTSD use drugs to alleviate emotional~     distress. This study will examine the role that negative emotional states play in sedative~     drug use among individuals with PTSD.~   "
252671|NCT00244322|"~     The purposes of this study are to determine:~        -  The safety of LY450139 dihydrate and any side effects that might be associated with it.~        -  How much LY450139 dihydrate should be given and how long it may be detected in blood.~        -  To determine if LY450139 dihydrate may have an effect on a protein found in blood,~          called A beta. This protein is studied in subjects with Alzheimer's disease.~        -  To collect and store samples from blood and spinal fluid for research related to~          Alzheimer's disease and similar (neurodegenerative) diseases or inflammation~          (irritation) that may provide information on how subjects respond to LY450139 or other~          medications.~      Length of study: Approximately 29 weeks.~      Number of office visits: 11 for most subjects: initial visit, every other week during 14~     weeks of study drug treatment, and 2 follow-up visits.~      At no cost, approximately 45 eligible participants will receive:~        -  Study medication~        -  Study-related diagnostic and laboratory evaluations~   "
252672|NCT00244309|"~     The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or~     another drug named dutasteride (Avodart), or a combination of these two drugs is effective in~     improving urinary symptoms and decreasing the rate of intermittent self-catheterization after~     prostate brachytherapy.~   "
252673|NCT00244296|"~     The purpose of this study is to determine how effective duloxetine is in treating women who~     are 65 years of age or older with symptoms of stress urinary incontinence, or with a~     combination of stress urinary incontinence and urge urinary incontinence symptoms.~   "
252674|NCT00244283|"~     To compare two different methods of protecting heart muscle from damage caused by a decreased~     blood supply. Exposure to the anaesthetic agent sevoflurane can allow the heart muscle to~     resist longer periods of low blood or oxygen supply without sustaining the amount of damage~     that it would otherwise expect to. The use of thoracic epidural analgesia improves the blood~     flow to the heart muscle and has also been shown to reduce the amount of damage the heart~     muscle may otherwise sustain. The aim of this study is to compare these two methods.~   "
252675|NCT00244270|"~     The purpose of this study is to evaluate the incidence of venous thrombosis occurring on~     totally implantable vascular access devices in cystic fibrosis patients who need a new device~     (it can be the first one or a subsequent one) and to study the genetic risk factors of~     thrombosis adjusted to the acquired ones.~      It is a nationwide cohort study planned for two years with a six month follow up period. The~     expected number of inclusion is 50 patients each year, that is to say 100 for the whole~     study.~      In cystic fibrosis, pulmonary exacerbations necessitate repeated intravenous antibiotics, but~     the peripheral blood accesses become precarious with time, leading to the indication of a~     central venous device. It is important to take a lot of precautions to protect vascular~     access. This allows the patient to have a dramatic improvement in life expectancy with such~     life-long devices (ONM, French National Observatory France 2003 : median at 36 years). Venous~     thrombosis can cause a superior cava syndrome, a pleural effusion or a pulmonary embolism.~     The risk of thrombosis is significant; retrospectively, it has been evaluated to be between 4~     and 16% in the publications. This rate may be higher due to the fact that venous thrombosis~     may remain asymptomatic, and therefore silent, but they lead to the same risk of vascular~     access loss.~   "
252676|NCT00244257|"~     This study is designed to investigate the safety of a single infusion of GMA161 in patients~     with idiopathic thrombocytopenic purpura, as well as, the way the drug enters and leaves the~     body. In addition, throughout the study, platelet counts and other blood cell numbers will be~     measured. NOTE: A decision was made to terminate this study in June 2008 due to low~     enrollment.~   "
252677|NCT00244244|"~     The primary purpose of this study is to evaluate the safety and tolerability of arimoclomol~     in ALS patients following 90 days of dosing. In addition, the amount of arimoclomol in blood~     and cerebrospinal fluid will be measured.~   "
252678|NCT00244231|"~     To assess the efficacy and safety of Nidadd (extended-release niacin) in patients with~     hyperlipidemia.~   "
252679|NCT00244218|"~     The purpose of this study is to determine whether tetrahydrobiopterin (BH4)is effective in~     treating patients with PKU.~   "
252680|NCT00244205|"~     To investigate the methylation status of 4-6 genes in Urine and matching bladder tissue~     biopsies, in order to find methylation markers for use in a noninvasive test in monitoring~     patients with bladder tumors.~   "
252681|NCT00244192|"~     The purpose of this study is to determine whether infliximab is effective on fat-free mass in~     the treatment of patients with moderate to severe COPD suffering from cachexia.~   "
252682|NCT00244179|"~     1. to investigate, whether one of the two alternative therapy strategies (antibiotic plus~          immunostimulation versus antibiotic plus immunosuppression) in chronic reactive~          arthritis is therapeutical superior to conventionel standardtherapy (DMARD).~        2. to investigate, whether one or more of the different therapy strategies cause an altered~          detection of bacterial DNA in the joint or colon.~        3. to measure the antigen-specific and -unspecific immune response (predominantly t-cell~          response) during therapy and correlate it with the clinical course.~        4. to gain knowledge from these analyses and the clinical course concerning the~          pathogenesis and the point of attack for possible therapies in chronic reactive~          arthritis.~        5. to compare cytokine-profiles of CD4- and CD8-positive T-cells from patients treated with~          infliximab to those treated with etanercept.~   "
252683|NCT00244166|"~     1. to investigate whether steroids are effective in ankylosing spondylitis~        2. if steroids are effective to describe how quick they work~   "
252684|NCT00244153|"~     Intraarticular application of opioids versus glucocorticosteroids versus placebo in knee~     arthritis~      study goals: assessment of effectiveness and tolerability of locally applied morphine,~     dexamethasone or placebo in knee arthritis~   "
252685|NCT00244140|"~     This is a research study involving the use of a contrast agent called Ultravist Injection.~     Ultravist, the study drug, is used to improve the pictures obtained using computed tomography~     (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case~     of this study, it will be injected into a vein in the patient's arm; from there, it travels~     through the blood stream and to the areas to be examined. CT scans will then be taken of the~     patient's head and/or body as ordered by his/her physician.~      Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When~     Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast~     Enhanced Computed Tomography (CECT) of the Head and/or Body~   "
252687|NCT00244114|"~     Based on the finding that anaphylactic reactions to Benefix (FIX) are associated with a~     specific IgE, a Basophil histamine release assay was selected to evaluate and demonstrate~     subject sensitization to FIX.~   "
252688|NCT00244101|"~     The best mode of delivery room stabilization for premature infants at high risk for~     respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct~     methods of post-delivery stabilization and subsequent early respiratory care on chronic lung~     disease and survival in premature infants at high risk for respiratory distress syndrome.~   "
252689|NCT00244088|"~     The aim of this study is to define the etiology of intra-abdominal infections, to study the~     role of Enterococcus spp and Pseudomonas aeruginosa in these infections and to clarify the~     need for specific enterococcal antimicrobial coverage.~   "
252690|NCT00244075|"~     The goal of this study is to evaluate the metabolic effects of concomitant use of three~     consecutive doses of recombinant human growth hormone over three days and exercise during~     continuous nutrient infusion in chronic hemodialysis patients. We would also like to evaluate~     the metabolic effects of nutritional supplementation alone without the additional anabolic~     strategies.~   "
252691|NCT00244062|"~     The study proposes to test the efficacy of a primary care-based brief intervention with women~     who resumed heavy drinking during the post-partum period and who used alcohol during a~     previous pregnancy. The trial will also examine the effects of tobacco use, illicit drug use,~     depression and domestic violence on alcohol use.~   "
252692|NCT00244049|"~     The goal of the study is to test the efficacy of brief clinician advice in reducing the~     frequency of high-risk drinking and alcohol-related harm in a population of college students~     seeking care at five university health care clinics. High-risk drinking is defined as 1) 8 or~     more episodes of heavy drinking (5 or more drinks in a row) in the past 28 days for male and~     female students, and/or 2) 50 drinks for male and 40 drinks for female students in the past~     28 days, and/or 3) 15 drinks for male and 12 drinks for female students in the past 7 days,~     and/or 4) One or more episode(s) of heavy drinking which includes 15 or more drinks in a row.~   "
252693|NCT00244023|"~     30 to 50% of the patients presenting with Erectile Dysfunction (ED) do not respond to PDE V~     Inhibitor therapy, which is presently considered as the first choice treatment for most ED~     patients. Recent reports stated a high prevalence of low serum testosterone levels in such~     non responders, and an improvement of their response by combining testosterone therapy with~     the PDE V Inhibitor. This suggests there may be a minimum threshold level of blood~     testosterone for a full effectiveness of PDE V Inhibitor therapy. Two double blind, placebo~     controlled studies have added support to this hypothesis but one involved only 20 patients~     while in the other the benefit of combining testosterone was transient. This is a~     multi-centric study, double blind placebo controlled and randomized as concerns testosterone~     administration, that aims to objectively assess the efficacy of co-administering testosterone~     with the PDE 5 inhibitor Tadalafil to improve the erectile function of a large group of ED~     patients non-responders to PDE V inhibitors alone. Patients will be screened to ensure~     inclusion and exclusion criteria completion, including a serum testosterone level < 4 ng/ml~     for total testosterone or < 1 ng/ ml for bioavailable testosterone. They will then enter a~     four week run-in period in the meanwhile they will receive Tadalafil 10 mg only, once daily,~     in order to confirm their non responsiveness to PDE V inhibitors and their eligibility to~     enter the treatment phase based on IIEF scoring, SEP diaries and a Global Assessment Question~     (GAQ). The patients still non responders after 4 weeks of Tadalafil 10 mg daily will enter a~     12 weeks treatment phase including visits at weeks 4, 8, 12 and 16. Treatment procedure will~     include: 1. continuation of Tadalafil at 10 mg dose daily followed by routine assessment~     using SEP diaries, IIEF scoring, GAQ and Aging Male Symptoms scale administered at each study~     visit. Safety assessments will be performed in addition during the last visit (physical~     examination including DRE, PSA and BCC). 2. Randomization in 2 parallel arms (Placebo gel +~     Tadalafil 10 mg daily, and Testosterone gel 50 mg + Tadalafil 10 mg daily). If indicated~     according to suboptimal clinical response of the patient, the dose of study medication will~     be increased at the 8 or 12 weeks visit to 100mg of testosterone or to 2 sachets of placebo~     gel. Up to 430 patients will be screened in order that 172 are enrolled in the double blind~     treatment phase.~   "
252694|NCT00244010|"~     Due to an overall and disease free survival of 85% to 100%, allogeneic blood or bone marrow~     stem cell transplantation using an HLA matched sibling donor is the therapy of choice for~     patients with severe aplastic anemia (SAA). Unfortunately, only about 25% of patients have~     such a donor. For patients with SAA lacking a matched sibling donor, immunosuppressive~     therapy is the current treatment of choice. Approximately 70% of these patients have a~     complete or partial response to immunosuppressive therapy, achieving transfusion independence~     and/or growth factor independence.~      For the approximately 30% of patients who do not respond to immunosuppressive therapy or~     experience recurrence, alternative donor (matched unrelated, partially matched family member)~     transplantation is a treatment option. However, graft rejection and graft-versus-host-disease~     (GVHD) are significant barriers to success, decreasing event-free survival to 30% to 50%.~      This study offers stem cell transplantation using a partially matched family member~     (haploidentical) donor to those patients with no available HLA-matched sibling or matched~     unrelated donor. In an attempt to reduce GVHD and regimen-related toxicity while maintaining~     adequate engraftment, we plan to infuse a highly purified stem cell graft. The Miltenyi~     Biotec CliniMACS CD3 depletion system will be used to derive a defined allogeneic graft~     highly enriched for CD34+ hematopoietic cells and depleted of CD3+ T-lymphocytes from G-CSF~     mobilized, donor-derived peripheral blood stem cells.~      Patients 21 years of age and younger with refractory cytopenias are also eligible for this~     protocol as there are no other potentially curative therapies currently available for these~     conditions.~      The primary objective of this study is to evaluate the safety of transplantation using a~     haploidentical donor product engineered to targeted cell counts using the investigational~     CliniMACS device for patients with refractory severe aplastic anemia (SAA) or refractory~     cytopenias. The treatment plan would be considered unsafe if we can find this type of~     procedure is associated with a significantly higher treatment failure rate. Treatment failure~     is defined as any occurrence of the following events, overall grade III-IV acute GVHD, graft~     failure or death due to any cause within 100 days after transplant.~   "
252695|NCT00243997|"~     The primary aim of this study is to test the effectiveness of the Becoming Parents Program--a~     couple focused educational program for couples having a first child--on individual and couple~     well being and the parent-infant relationship over the first three years of parenthood.~      Other aims of this study are to evaluate the cost of implementing the Becoming Parents~     Program; to describe changes in individual and couple well-being over time, viewing the~     transition to parenthood from a developmental perspective using data from the control group;~     examine the various variables in the study over time from pregnancy through three years~     post-birth.~   "
252696|NCT00243984|"~     The purpose of this study is to evaluate the efficacy of topiramate compared to placebo in~     the treatment of obesity in metabolic syndrome. Secondary objectives include topiramate and~     weight loss effects on lipid levels, HbA1C, insulin resistance, and blood pressure.~   "
252697|NCT00243971|"~     The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole~     on the control of early morning motor impairment and sleep disorders in subjects with~     early-stage PD.~      Subjects who meet eligibility criteria will be randomly assigned either to rotigotine~     transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and~     ropinirole until an individual optimal dose is achieved. Following a Titration period of up~     to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be~     maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period,~     subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial.~      The first subject was enrolled in December 2004. The last subject was enrolled in June 2005.~     Last subject out is expected for October 2005. The trial is still ongoing.~   "
252698|NCT00243958|"~     Hearing impairment either clinical or subclinical is a characteristic of some renal disease~     patients. The hearing impairment could be result from specific etiologies or chronic renal~     failure itself. The causes of hearing impairment in renal disease patients ranged from drugs~     intoxication in both auditory and renal function, like gentamycin or isoniazid, congenital~     disease like Alport syndrome or other collagen-defective renal disease, or just aging~     related. End-stage renal disease (ESRD) patients are special in many parts to general~     population who have hearing impairment. First, inflammation in ESRD patients is~     well-documented, second, they suffered from various underlying diseases which auditory~     function was potentially impaired, third, they need to undergo renal replacement therapy~     either hemodialysis (HD) or peritoneal dialysis (PD) to maintain their life. Dialysis itself~     was found to be a cause of hearing impairment, too. The biochemical change and constitutive~     inflammation status are thought to be implicated in the pathogenesis of hearing impairment in~     ESRD patients. Aluminum (Al) is a well-documented heavy metal, which predisposes to~     Alzheimer’s disease, dementia or some neurologic diseases. Al intoxication is very rare in~     general health population but elevated serum Al level is easily found in ESRD patients since~     they can not excrete Al by damaged kidneys and dialyzers. Inner ear per se is a neurologic~     tissue, so if serum Al level in ESRD patients has any association in their haring function~     needs to be studied.~   "
252699|NCT00243945|"~     The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of~     early morning motor impairment and sleep disorders in subjects with idiopathic PD.~      Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal~     patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose.~     Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or~     maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to~     enter into an open-label extension study.~      The first subject was enrolled in December 2004. The last subject was enrolled in April 2005~     and the last subject visit was conducted in July 2005. This study is now closed~   "
252700|NCT00243932|"~     The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in~     individuals with ALS for a possible future phase III study.~   "
252701|NCT00243919|"~     The purpose of this study is to compare two different treatments to improve walking after~     stroke (or post-stroke).~   "
252702|NCT00243906|"~     The purpose of this study is to examine the effects of delivering intra-arterial recombinant~     tissue plasminogen activator (rt-PA) and ultrasound to the site of the blood clot blocking~     blood flow to the brain of stroke patients.~   "
252703|NCT00243893|"~     The purpose of this pilot study is to investigate the use of minocycline and doxycycline as~     medical therapy for inoperable or partially treated arteriovenous malformations (AVMs) and~     giant aneurysms.~   "
252704|NCT00243880|"~     The purpose of this dose escalation study is to evaluate the use of lovastatin for the~     treatment of acute ischemic stroke.~   "
252705|NCT00243867|"~     The primary objective of this trial is to compare the survival of patients with advanced~     non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with~     carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized~     trial. In addition, the response rate to each regimen, response duration, time to progression~     and time to treatment failure will be measured. Toxicity will be evaluated and compared~     between the two groups.~   "
252706|NCT00243854|"~     To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy~     concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva)~     in the treatment of patients with resectable pancreatic cancer.~   "
252707|NCT00243841|"~     The purpose of this study is to determine the maximum tolerated dose of limited fractions of~     large dose radiation in an effort to achieve a biologically potent cancer therapy in selected~     patients with primary hepatocellular carcinoma.~   "
252708|NCT00243828|"~     Total-face mask may improve the efficacy of NIV compared to conventional face mask in~     patients with acute respiratory failure due to enhanced tolerance and the allowance of higher~     airway pressure without massive leaks.MAIN OBJECTIVE: To assess, in acute respiratory failure~     patients, whether the total-face mask reduce the intubation rate. METHODS: 300 patients~     admitted in the ICU for acute respiratory failure needing continuous noninvasive mechanical~     ventilation. The type of mask (total-face vs. conventional face mask) will be randomized.~     Defined failure criteria and weaning technique will be used.~   "
252709|NCT00243815|"~     This research will determine whether prophylactic use of ibuprofen can prevent common side~     effects of the copper intrauterine device (IUD) and prevent early removal of the device.~   "
252710|NCT00243802|"~     The purpose of the study is to look at the differences between people who have irregular~     heart beats coming from the upper chamber of the heart (atrial fibrillation) compared to~     those who do not have these irregular beats.~   "
252711|NCT00243789|"~     The purpose of this study is to see if male children with Duchenne muscular dystrophy (DMD)~     have changes in strength when given the drug Pentoxifylline as a rescue treatment. A total of~     64 subjects are expected to participate through all other centers of the Cooperative~     International Neuromuscular Research Group (CINRG) worldwide.~      The primary purpose of this study is to see whether the addition of pentoxifylline to a~     steroid regimen is effective in treating deteriorating muscle strength by comparing the~     muscle strength of PTX treated subjects and placebo treated subjects.~   "
252712|NCT00243776|"~     The study team will use small pieces of human hearts which are removed as part of a required~     surgical procedure to study how calcium ions pass through the membrane of heart cells in~     order to tell the heart cell how much force to contract with when the heart beats.~     Investigators will also study the proteins and RNA of these pieces to determine how the~     newborn heart cells control their force of contraction differently from adult heart cells.~     Investigators hypothesize that infant hearts have different regulation of calcium entry than~     adult hearts.~   "
252713|NCT00243763|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD), dose~     limiting toxicity (DLT), and safety profile of CHIR-258 when administered to subjects with~     refractory or relapsed multiple myeloma (MM).~   "
252714|NCT00243750|"~     Assessing the efficacy and tolerability of methotrexate 15mg sc in the first month of~     treatment- if well tolerated methotrexate 20mg sc in the following 3 months in patients with~     active anklyosing spondylitis~   "
252715|NCT00243737|"~     Treatment of Plasmodium falciparum malaria in Africa is increasingly difficult. Resistance to~     cheap efficient antimalarial drugs poses an increasing threat. The rapid emergence of~     resistance to sulfadoxine - pyrimethamine, already seen in East Africa is growing and is~     likely to have an striking impact on mortality in many other African regions where no obvious~     alternatives are available. WHO recommends the use of drug combinations containing~     artemisinin compounds, i.e., artemisinin-based combination therapies (ACT). Previous clinical~     trials have shown that the combination of artesunate with mefloquine is highly effective and~     well tolerated in the treatment of multidrug-resistant falciparum malaria, retaining the~     benefit of rapidity of action while augmenting cure rates, and apparently slowing the~     development of mefloquine resistance. Compliance with sequential combination regimen of~     antimalarial drugs is notoriously poor. Therefore, in order to limit the development of~     resistance to both drugs and ameliorate patients' compliance to antimalarial treatments, an~     optimal simultaneous combination regimen of artesunate and mefloquine in a practical single~     blister pack has been developed by Mepha Ltd. and successfully tested. The currently~     available~   "
252716|NCT00243724|"~     Determine if different levels of acid-suppression with esomeprazole for 6 months on chosen~     histological markers of esophageal epithelial acid-related disease in patients with upper GI~     symptoms.~   "
252717|NCT00243711|"~     The efficacy, safety and acceptability of an investigational lubricant eye drop in subjects~     with dry eye will be evaluated in comparison with currently-available lubricant eye drops.~   "
252718|NCT00243698|"~     Ultrasound is a well-established imaging modality for the evaluation of breast disease.~      The investigators' objective is to characterise the properties of an intravascular~     ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the~     diagnostic value of the ultrasound examination in patients with different breast lesions.~      The final purpose of this ultrasonography is to allow the early detection of tumors and to~     improve the differentiation between benign and malignant lesions.~      SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable,~     resistant to pressure, and specifically designed to be used as a contrast agent for~     ultrasound imaging.~      Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the~     morphology of breast tumour vascularity.~   "
252719|NCT00243685|"~     DiaTech is a private company performing patient specific cancer chemosensitivity testing for~     patients and physicians. DiaTech Oncology is doing this clinical study to see if an~     experimental new technology called the microculture kinetic (MiCK) assay will predict~     treatment outcome and can help to direct the chemotherapy of cancer subjects. This study is~     focused on subjects diagnosed with breast, ovarian, lung, and colon malignancies and~     low-grade lymphomas.~      Study Objectives:~        -  To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of~          cancer patients.~        -  To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients.~   "
252720|NCT00243672|"~     Rupture of unstable atherosclerotic plaques is the underlying pathophysiologic mechanism of~     acute coronary syndromes and thus also of perioperative myocardial ischemia. Lipid lowering~     drugs such as statins and fibrates have been shown to improve the outcomes of patients with~     atherosclerosis. This is not only mediated through their therapeutic actions on lipid~     metabolism, but relies on a multitude of pleiotropic effects of these substances. One of the~     most interesting of these effects is the stabilisation of atherosclerotic plaques.~      To investigate these effects in a perioperative setting, patients scheduled for~     thromboendarterectomy of the carotid artery will be recruited. They will be randomised to~     receive either atorvastatin 10mg/d, gemfibrozil 1200mg/d or placebo for two weeks~     preoperatively. Specimens of carotid plaques will be obtained intraoperatively. After~     microscopic characterisation of plaques, DNA-microarray analyses will be done to gain~     insights into the transcriptional regulation and expression profiles of various types of~     atherosclerotic plaques under different pharmacological circumstances (stable or unstable~     with statin/fibrate/placebo).~   "
252721|NCT00243659|"~     This study will examine the efficacy and safety of ReFacto AF in patients with severe and~     moderately severe hemophilia A undergoing elective major surgery when administered by either~     bolus injections (BI) or continuous infusion (CI).~   "
252722|NCT00243646|"~     Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of~     pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in~     hormonally-manipulated patients.~   "
252723|NCT00243633|"~     The conventional sonography is frequently used to detect incidental focal liver lesions~     because of its availability, innocuity and low cost. Nevertheless, sensibility and~     specificity of conventional sonography does not exceed 70% for tumoral affections.~     Consequently the interest of this practice must be reconsidered by studying its ratio~     cost/diagnosis contribution.~      These limitations of conventional sonography have led to the use of other imaging modalities~     and invasive or costly procedures such as computed tomography (CT), magnetic resonance~     imaging (MRI) or biopsy. The availability of real-time contrast-enhanced ultrasound imaging~     (CEUS) has changed the strategy in the characterization of focal liver lesions, on healthy or~     cirrhotic liver in a neoplastic context or not, without inconvenience for the patient.~      The aim of the present study is to evaluate the place of CEUS in term of diagnostic relevance~     and catch of load cost, in the characterization of focal liver lesions detected but not~     characterized by CT or conventional sonography.~   "
252724|NCT00243620|"~     Current treatment modalities for chronic leg ulcers are time consuming, expensive, and only~     moderately successful. Recent data suggest that creating a sub-atmospheric pressure by Vacuum~     Assisted Closure (V.A.C.®) therapy supports the wound healing process. Here, we studied the~     efficacy of V.A.C.® in the treatment of chronic leg ulcers prospectively.~   "
252725|NCT00243607|"~     Breast cancer survivors often suffer from climacteric symptoms caused by treatment or~     diagnosis of their disease.~      Hormone replacement therapy is contraindicated and other pharmacological options may also~     include the risk of stimulating hormone receptors. Hydrotherapy following the guidelines of~     naturopathy by S. Kneipp is a non-pharmacological treatment option which may influence~     climacteric symptoms by affecting the regulation of body temperature. In this study, the~     regular self application of hydrotherapy after initial training by a professional will be~     evaluated for its efficacy, practicability, and compatibility.~   "
252726|NCT00243594|"~     Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As~     such they are currently used in clinical vaccination protocols in cancer patients, and both~     immunological and clinical responses have been observed. For these therapies accurate~     delivery to target organs is essential. Correct delivery and subsequent migration of~     vaccinated DCs to regional lymph nodes is of paramount importance for effective stimulation~     of the immune system. Currently it is not known what the best route of administration is for~     DC vaccines.~      Using magnetically labeled DCs, we investigate the potential of MRI cell tracking to monitor~     DC therapy. This is investigated in stage III/IV melanoma patients in whom a regional lymph~     node dissection is scheduled. Autologous monocyte-derived DCs are labeled with the clinically~     approved superparamagnetic iron oxide (SPIO) formulation Endorem and 111In-oxine and injected~     either in the skin or directly in lymph nodes under ultrasound guidance. Two days after~     vaccination patients are monitored with scintigraphy and MR imaging. Lymph nodes are then~     resected. Subsequently patients receive 3 more vaccination with DCs. During and after therapy~     immune responses against the used melanoma peptides are monitored.~   "
252727|NCT00243581|"~     The objective of this study is to evaluate the effect of the Ornish Program on cardiovascular~     disease as measured by the IMT of the common carotid artery, and to compare this effect to~     outcomes from patients participating in traditional cardiac rehabilitation.~   "
252728|NCT00243568|"~     This is an international study of vicriviroc in 500 adult HIV-infected subjects who are~     failing standard antiretroviral therapy (ART). HIV must be of a certain type known as~     R5/X4-mixed tropic. Subjects allowed into the trial will be randomly assigned to treatment~     with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to other~     antiretrovirals (selected by the investigator to be optimal for the specific subject)~     containing at least 3 drugs, including a protease inhibitor (PI) boosted with at least 100 mg~     ritonavir QD. Subjects will be continued for up to 48 weeks of dosing.~   "
252729|NCT00243555|"~     The purpose of this study is to develop a tool to better predict clinical allergy to peanut,~     so that those who are skin test positive but non allergic will not have to unnecessarily~     avoid peanut, and those with true allergy can be diagnosed, possibly without oral ingestion~     challenge, and treated appropriately~   "
252730|NCT00243542|"~     The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in~     treating subjects with acne who have certain blood disorders.~      ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in~     people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and~     was shown to reduce the number of pimples and improve acne.~      The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called~     G6PD deficiency, methemoglobin reductase deficiency, and hemoglobin M have a higher~     chance of side effects with dapsone.~      G6PD is short for glucose-6-phosphate dehydrogenase. It is an enzyme found in red blood~     cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to~     function normally. Some people have less G6PD in their red blood cells than the average~     person. This is called G6PD deficiency.~      Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.~   "
252731|NCT00243529|"~     Dendritic cells (DCs)are the most potent antigen-presenting cells of the immune system, as~     such they are able to direct the immune system specifically against cancer cells. Currently~     DCs are used in clinical vaccination studies and immunological and clinical responses have~     been observed. For inducing anti-tumor immunity, the DCs have to be loaded with tumor antigen~     (i.e. molecular structures that are presented by the tumor, that are recognized by the immune~     system). Currently most studies use tumor peptides (small protein fragments) for this~     purpose. This approach has several disadvantages: only patients with a certain HLA-type can~     be treated and the immune response that is induced by the vaccine is limited to the used~     peptides. These disadvantages do not exist when the DCs present antigen which is endogenously~     processed, for example after RNA transfection. For this reason we investigate the~     immunogenicity of DCs that are pulsed with peptides or transfected with mRNA encoding~     melanoma associated antigens in stage III and IV melanoma patients.~   "
252732|NCT00243516|"~     The purpose of this study is to evaluate if the implementation of quantitative pretest~     probability assessment will significantly reduce the unnecessary use of the intra-emergency~     department chest pain center. Specifically, the study will examine whether the PREtest~     Consult acute coronary syndrome (ACS) pretest probability assessment system can significantly~     reduce the use of chest pain unit evaluation in very low risk emergency department (ED)~     patients, can safely discharge patients with a pretest probability ≤ 2.0%, can reduce~     unnecessary procedures and lower hospital costs and will examine patient satisfaction of~     patients with whom pretest probability assessment was used compared to those with whom it was~     not used.~      The researchers hypothesize that patients in the control group of the study will have~     statistically significant reductions in mean time spent in the emergency department, mean~     charges billed to the patient or their insurance carrier, hospital length of stay, mean~     number of procedures or tests performed without a statistically significant change in patient~     satisfaction or adverse outcome.~   "
252733|NCT00243503|"~     The current study is to evaluate: Overall response rate for the combination of trastuzumab~     and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and~     tolerability of the combination; measure duration of tumor control and survival; assess~     patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and~     safety.~   "
252734|NCT00243490|"~     Primary Objective:~        -  The primary objective is to evaluate the efficacy of photodynamic therapy in the~          treatment of malignant intracranial tumors.~      Secondary Objective:~        -  The secondary objective is to evaluate the safety of photodynamic therapy in the~          treatment of malignant intracranial tumors.~   "
252735|NCT00243477|"~     The purpose of this study is to determine the effect of an antidepressive medication~     (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year~     post-operative morbidity and mortality after coronary artery bypass grafting~   "
252736|NCT00243464|"~     The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of~     calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment~     of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is~     patients with clear or minimal disease after 8 weeks treatment.~      Further the occurrence of relapse and rebound after end of treatment in patients with clear~     or minimal disease will be investigated.~   "
252737|NCT00243451|"~     Our central hypothesis is that the early metabolic lesions of MCI can be reliably detected in~     individual subjects by objective analysis of [18]F-fluorodeoxyglucose (FDG) positron-emission~     tomography (PET) brain images, earlier and more accurately than by subjective clinician~     rating.~   "
252738|NCT00243438|"~     Prospective Internet-Registry, Postmarketing-Surveillance, Registration and Follow-up of~     patients after Multi-Link VISION™ - Stent Implantation~   "
252739|NCT00243425|"~     The investigators propose to answer the following research question: Does a multifaceted,~     culturally tailored intervention that focuses on the specific concerns and preferences of~     African American patients with depression and their primary care providers improve the~     processes and outcomes of care for African Americans to a greater degree than a standard~     state-of-the art depression intervention?~      This study will determine whether two new educational programs can improve the care for~     depression in African Americans. These programs may include visits with a depression case~     manager and access to educational materials, such as a videotape, a calendar, pamphlets, and~     books. One program is a standard quality improvement program for depression that has been~     shown to be effective in most patients. The other program is similar, but has materials that~     focus more on the patient’s specific culture, beliefs, values, and preferences.~   "
252740|NCT00243412|"~     This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the~     safety and efficacy of rituximab, administered at two different regimens for 2 years, in~     patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of~     methotrexate (MTX).~   "
252741|NCT00243399|"~     The purpose of this study is to evaluate the safety of the drug oxandrolone (a type of~     androgen steroid) in patients with Fanconi anemia (FA), and to determine if this drug can~     help in the treatment of bone marrow failure in these patients. Androgen steroids are male~     hormones that can stimulate the production of red blood cells (the cells which carry oxygen~     in the blood) and platelets (cells that help blood clot).~   "
252742|NCT00243386|"~     The primary purpose of this randomized, two-arm parallel clinical study in 66 previously~     treated patients with severe or moderately severe hemophilia A is to compare the rate of~     bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose~     determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6~     hours; actual dose determined by Baxter utilizing an algorithm and the patient's~     pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the~     prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled~     patients will be treated originally on demand for a period of 6 months and then they will be~     randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of~     12 months +/- 2 weeks.~   "
252743|NCT00243373|"~     This study will investigate the impact of barcode technology on medication errors made by~     nursing. In addition, it will measure the impact of this technology on nursing workflow and~     satisfaction.~   "
252744|NCT00243360|"~     The purpose of this study was to determine if a multi-faceted intervention to implement~     diagnostic and therapeutic algorithms for management of suspected urinary infection in~     nursing home residents could reduce antibiotic prescribing for urinary indications in this~     population.~   "
252745|NCT00243347|"~     This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC.~     The safety and tolerability of AZD2171 will also be studied.~   "
252746|NCT00243334|"~     The purpose of this study is to evaluate the impact of integrating ambulatory computerized~     physician order entry (ACPOE) and advanced clinical decision support systems (CDSS) on safety~     and quality domains in the ambulatory setting, including: a) medication monitoring, b)~     preventive care and chronic disease management, and c) test result follow-up. In addition we~     will evaluate the impact on organizational efficiency, physician workflow and satisfaction,~     and perform a cost-benefit analysis. We hypothesize that the value of ACPOE integrated with~     advanced CSDSS lies in improved medication safety and guideline compliance, but also improved~     efficiencies for the provider and the health-care system.~   "
252747|NCT00243321|"~     The principal objective of this study is to demonstrate that patients can safely receive~     combined High Dose Rate brachytherapy and Intensity-Modulated Radiation Therapy without~     experiencing a treatment limiting toxicity.~   "
252748|NCT00243308|"~     Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation~     MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours~     before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2~     contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for~     percutaneous coronary angioplasty. The primary objective of this study is to evaluate the~     safety of Serp-1 injection when administered in 3 daily doses to patients undergoing~     conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.~   "
252749|NCT00243295|"~     To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic~     studies, with assessment of the following parameters:~        -  Injecting the desired volume of rhBMP-2/CPM within the defect~        -  Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence~          of rhBMP-2/CPM.~   "
252750|NCT00243282|"~     Dyspnea (shortness of breath) is a complex experience that includes interpretation of~     physical impairments and associated distress to the person. The role of mind-body~     interactions in the experience of the symptom of dyspnea suggests that complementary and~     alternative medicine (CAM) therapies may be effective in abating dyspnea and improving~     patients' health-related quality of life. CAM strategies work in a number of ways that are~     directly applicable to dyspnea, such as decreasing the stress response, inducing relaxation,~     and facilitating a less distressful interpreted experience of physical disorders.~      We have combined a number of established CAM approaches aimed at breath-centered mindfulness~     and relaxation into an single therapy, mind-body breathing therapy (MBBT). The purpose of~     this study is to test the efficacy of MBBT in improving dyspnea and health-related quality of~     life for patients with emphysema (chronic obstructive pulmonary disease).~   "
252792|NCT00242736|"~     The purpose of this study is to evaluate whether there is a difference in proportion of~     patients with resolution of heartburn and other symptoms related to gastroesophageal reflux~     disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects~     with Erosive Esophagitis (EE) and those without EE.~   "
252751|NCT00243269|"~     This study hypothesizes that patients receiving efficacy enhancing information about the~     acupressure bands will expect less treatment-related nausea, which will subsequently result~     in less treatment-related nausea compared to patients who do not receive such information.~      This study extends prior research by utilizing a randomized controlled trial in a clinical~     environment to examine the efficacy of an intervention that is specifically designed to~     reduce patients' response expectancies concerning nausea development from cancer treatments,~     and, thereby, reduce nausea.~      The objectives of this study are as follow:~        1. To provide preliminary data on whether a two-tiered strategy to increase patients'~          expectancies for nausea prevention and/or management will result in reduced~          chemotherapy-induced nausea.~        2. To provide preliminary data on whether a two-tiered strategy to increase patients'~          expectancies for nausea prevention and/or management will result in increased~          health-related quality of life (HRQL) in patients receiving emetogenic chemotherapy.~      To provide preliminary data on whether a two-tiered strategy to increase patients'~     expectancies for nausea prevention and/or management is more effective than a single-tiered~     strategy in reducing chemotherapy- induced nausea.~   "
252752|NCT00243256|"~     The purpose of the study is to evaluate if supplementation with vitamin D in doses of~     20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as~     compared to placebo during 1 year.~   "
252753|NCT00243243|"~     The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or~     NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower~     the amount of blood lost during burn surgery.~   "
252754|NCT00243230|"~     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government~     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5~     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells~     that fight infection). The purpose of this 48-week study is to evaluate 2 dose levels of~     vicriviroc in HIV patients who have not responded adequately to standard HIV treatments. This~     study was designed to evaluate these doses of vicriviroc, when taken in combination with~     other appropriate HIV drugs, in terms of ability to decrease the level of HIV (viral load) in~     the blood and safety~   "
252755|NCT00243217|"~     The objective of this trial is to demonstrate clinical efficacy of four different dosages of~     SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15~     cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936)~     will be more effective than placebo. The tolerability and safety of rotigotine will be~     assessed.~   "
252756|NCT00243204|"~     This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus~     placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy~     regimen.~   "
252757|NCT00243191|"~     The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma~     protuberan tumors.~   "
252758|NCT00243178|"~     The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily~     (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation~     therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at~     least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel~     plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a~     vitamin K antagonist) will result in the same risk of the composite outcome of stroke,~     non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial~     fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel~     has a lower risk of hemorrhage than standard anticoagulation therapy.~   "
252759|NCT00243165|"~     This study will include 60 patients with early breast cancer referred to receive adjuvant~     chemotherapy with AC ( adriamycin- cyclophosphamide) or CAF ( adriamycin- cyclophosphamide-~     5- fluorouracil ) combinations. These patients will receive every day one spoon of Lifemel~     honey or regular honey ( double blind)- during the adjuvant chemotherapy .Every week a WBC~     count will be performed in order to record the influence of Lifemel on myelotoxicity.~   "
252760|NCT00243152|"~     The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine~     (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic~     resonance imaging (fMRI).~   "
252761|NCT00243139|"~     The purpose of this study was to determine how effective a custom-made standard dental splint~     (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and~     further to find factors for identification of those patients likely to benefit from this~     treatment.~   "
252762|NCT00243126|"~     This is an exploratory/developmental study to support the early phases of development and~     evaluation of a family-based HIV prevention program for adolescent girls prior to a~     full-scale trial. Research on the new intervention will include evaluating the feasibility,~     tolerability, and acceptability of the intervention, and allow us to obtain the preliminary~     data needed as a pre-requisite to a larger-scale intervention study.~      Adolescent females and their mother/guardian will be randomized to either: a family-based~     risk reduction intervention; or a no-treatment control group condition. Participants in both~     conditions will be assessed at baseline, immediate post-intervention, and at 3- and 6-month~     follow-ups. A subset of families (12 adolescents and 12 mothers) will participate in a~     qualitative interview following the 6-month follow-up, in which information will be obtained~     on participant perception of procedures and intervention content, and whether they have~     utilized skills taught following the end of the project.~   "
252763|NCT00243113|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel together with~     radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation~     therapy works in treating patients with stage II or stage III cancer of the larynx or~     hypopharynx.~   "
252805|NCT00242567|"~     This study aims to determine whether early treatment with zoledronic acid, that is given~     during the early phase of advanced prostate cancer, will be more efficacious than delayed~     treatment~   "
252806|NCT00242554|"~     To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability~   "
252764|NCT00243100|"~     This phase I trial is studying the side effects and best dose of vorinostat and gemcitabine~     in treating patients with metastatic or unresectable solid tumors. Drugs used in~     chemotherapy, such as vorinostat and gemcitabine, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may~     also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth~     and by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells.~   "
252765|NCT00243087|"~     RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating~     patients with refractory or relapsed advanced non-Hodgkin's lymphoma.~   "
252766|NCT00243074|"~     This phase II trial is study how well AZD2171 works in treating patients with malignant~     pleural mesothelioma that cannot be removed by surgery. AZD2171 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to~     the tumor~   "
252767|NCT00243061|"~     This phase II trial is studying how well AZD2171 works in treating patients with recurrent or~     stage IV melanoma. AZD2171 may stop the growth of tumor cells by blocking blood flow to the~     tumor and by blocking some of the enzymes needed for cell growth.~   "
252768|NCT00243048|"~     RATIONALE: Eating a diet high in soy foods may slow the progression of some types of cancer.~     Isoflavones are compounds found in soy food that may slow the growth of prostate cancer cells~     and prevent further development of prostate cancer. Radiation therapy uses high-energy x-rays~     to kill tumor cells. Giving isoflavones together with radiation therapy may be an effective~     treatment for prostate cancer.~      PURPOSE: This randomized phase II trial is studying the side effects and how well giving~     isoflavones together with radiation therapy works in treating patients with localized~     prostate cancer.~   "
252769|NCT00243035|"~     This phase I/II trial is studying the side effects and best dose of tipifarnib when given~     together with bortezomib and to see how well they work in treating patients with relapsed~     multiple myeloma. Tipifarnib and bortezomib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Giving tipifarnib together with bortezomib may~     kill more cancer cells.~   "
252770|NCT00243022|"~     RATIONALE: Giving the herb Boswellia serrata after surgery and radiation therapy may slow the~     growth of any remaining tumor cells. It is not yet known whether giving Boswellia serrata~     together with standard treatment is more effective than standard treatment alone in treating~     high-grade gliomas.~      PURPOSE: This randomized phase II trial is the study of a combination of complementary and~     alternative medicine (CAM) herbal supplement intervention as an adjuvant to standard~     treatment of patients with newly diagnosed and recurrent high-grade gliomas (HGG). The~     central hypothesis of this application is that a herbal preparation that inhibits 5-LO~     activity, will produce measurable biologically meaningful decrease in 5-LO eicosanoid~     production and brain edema that will be associated with improved survival and quality of life~     in patients with HGG.~   "
252771|NCT00243009|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy~     before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune system and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving cyclosporine and mycophenolate~     mofetil after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body~     irradiation works in treating patients who are undergoing a donor stem cell transplant for~     metastatic kidney cancer that cannot be removed by surgery.~   "
252772|NCT00242996|"~     RATIONALE: Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as~     rituximab, and chemotherapy, such as cyclophosphamide, helps stem cells move from the~     patient's bone marrow to the blood so they can be collected and stored for peripheral stem~     cell transplant. Giving chemotherapy, such as carmustine, etoposide, and cyclophosphamide,~     before transplant stops the growth of cancer cells by stopping them from dividing or killing~     them. The stem cells are then returned to the patient to replace the blood-forming cells that~     were destroyed by the chemotherapy. More rituximab is given after transplant to kill any~     remaining cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with~     cyclophosphamide and G-CSF followed by combination chemotherapy works in treating patients~     undergoing an autologous stem cell transplant followed by rituximab and GM-CSF for refractory~     diffuse large B-cell lymphoma.~   "
252773|NCT00242983|"~     RATIONALE: Studying quality-of-life in patients undergoing cancer treatment may help identify~     the intermediate and long-term effects of treatment on patients with cancer.~      PURPOSE: This clinical trial is studying quality of life in patients who are receiving either~     vinorelbine, gemcitabine, and docetaxel or paclitaxel and carboplatin for advanced non-small~     cell lung cancer.~   "
252774|NCT00242970|"~     Subjects with a burn to the face and/or neck will be enrolled into the study and a~     Three-Dimensional scanner used to see if it can objectively measure scar color and volume and~     measure the effect of scar on motion of the face and neck.~   "
252775|NCT00242957|"~     The IMAGE Study is a cluster randomised trial of a structural intervention for the prevention~     of HIV and gender based violence being conducted in South Africa.~   "
252776|NCT00242944|"~     The purpose of this study is to compare the effects of pitavastatin and atorvastatin on~     coronary plaque volume in patients with acute coronary syndrome and to clarify the~     relationship between coronary plaque volume, serum lipids, and inflammation markers in order~     to determine the significance of intensive lipid lowering therapy in patients with acute~     coronary syndrome in Japan.~   "
252807|NCT00242541|"~     The purpose of this study is to evaluate the efficacy of octreotide acetate to decrease GH~     and IGF-I levels in acromegalic patients, with microadenomas (≤ 10 mm) or macroadenomas (> 10~     mm).~   "
252808|NCT00242528|"~     To evaluate the safety and tolerability of intravenous zoledronic acid in the treatment of~     patients with multiple myeloma stage III with bone lesions related to Cancer.~   "
252897|NCT00241358|"~     The purpose of this study is to determine if peripheral blood cells collected following~     AMD3100 mobilization can be used safely for hematopoietic cell transplantation into~     HLA-matched recipients.~   "
252777|NCT00242931|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy~     before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune system and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving cyclosporine and mycophenolate~     mofetil after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body~     irradiation works in treating patients who are undergoing a donor stem cell transplant for~     progressive metastatic prostate cancer that has not responded to previous hormone therapy.~   "
252778|NCT00242918|"~     The purpose of this study is to determine the safety and effectiveness of the combination of~     docetaxel and ZD1839 on destroying prostate cancer before removal of the prostate.~   "
252779|NCT00242905|"~     Memory is a cognitive function whose development is still poorly documented in children, but~     which is often disturbed in temporal epilepsy. There are no studies about the disorders of~     episodic memory. The investigations using functional MRI (fMRI) are scarce, they do not~     involve this field and none are dedicated to children. The objectives of this project are to~     study the neuronal networks involved in episodic memory in normal children, as well as the~     disorders of episodic memory in children with epilepsy and the mechanisms of cognitive and~     cerebral reorganization in epilepsy.~   "
252780|NCT00242892|"~     Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis~     into the stent. Intra coronary pressure would allow the stent to be well deployed and so the~     restenose into the stent should diminish.~      Primary purpose : this study intend to test the hypothesis of optimal spreading of coronary~     stent guided with pressure into coronary arteritis comparing 2 strategies with patients~     having a coronary procedure with stent, excluded patients with myocardial infarction.~   "
252781|NCT00242879|"~     This is a two phase study (randomised and non-randomised phase). The randomised phase will~     initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current~     background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor~     (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy.~     Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of~     the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on~     resistance testing at screening. Subjects will remain in the randomized phase on one of these~     4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the~     randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies.~     After dose selection subjects will move to the non-randomised phase of the study. In the~     non-randomised phase subjects who are receiving GW640385 will be assigned to final selected~     dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral~     activity.~   "
252782|NCT00242866|"~     Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric~     oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of~     NOS, and therefore NO, may be an effective technique for the prevention of migraine headache.~     GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory~     activity in migraine through a novel mechanism of action. The intent of this study is to~     investigate the safety and efficacy of GW274150 for the prophylactic treatment of migraine~     headache.~   "
252783|NCT00242853|"~     This study is being conducted to validate various biomarkers in patients with RA with varying~     levels of disease severity. Subjects with a diagnosis of rheumatoid arthritis (RA) will be~     included as controls. The sudy will measure the baseline levels and the intra- and~     inter-subject variability of exhaled nitric oxide (NO) in patients with inactive/mild and~     moderate/severe RA on stable therapy or during a course glucocorticoids. In addition exhaled~     NO levels will be correlated with intra-articular inflammation (power Doppler~     ultrasonography) as well as markers of systemic inflammation (CRP, ESR).~   "
252784|NCT00242840|"~     This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy~     in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908~     (fosamprenavir)-containing regimen.~   "
252785|NCT00242827|"~     An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients~     with Advanced Multiple Myeloma.~   "
252786|NCT00242814|"~     The objective of the study is to compare PPAR activities (increase of adiponectin level)~     between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with~     metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of~     the metabolic syndrome after 6 weeks of treatment.~      An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma~     stimulation) in 30 subjects (15 per arm).~   "
252787|NCT00242801|"~     This study is being carried out to see if adding ZD1839 to other standard supportive care is~     more effective than standard supportive care alone for the treatment of patients with NSCLC~     whose disease has recurred after previous chemotherapy treatment.~   "
252788|NCT00242788|"~     The primary objective of the Phase I part of the study is to determine the recommended dose~     of capecitabine to be administered in combination with ZD1839 250 mg orally once daily in~     subjects with advanced or metastatic colorectal cancer by assessing DLTs.~      The primary objective of the Phase II part of the study is to estimate the objective response~     rate (complete response [CR] and partial response [PR]) at study closure for ZD1839~     administered in combination with capecitabine in subjects with advanced or metastatic~     colorectal cancer using the Response Evaluation Criteria in Solid Tumours (RECIST).~   "
252789|NCT00242775|"~     The purpose of this study is to compare the efficacy and safety of a variable dose of~     Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the~     treatment of asthma.~   "
252790|NCT00242762|"~     The primary objective of the study is to evaluate the activity of the combination ZD1839,~     docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by~     estimating the objective response rate (complete response [CR] and partial response [PR]) at~     study closure.~   "
252791|NCT00242749|"~     · To evaluate the disease free survival rate at 2 years of patients with advanced head and~     neck carcinoma treated with ZD1839 250 mg administered once daily in combination with~     cisplatin and a standard course of radiotherapy.~   "
252793|NCT00242723|"~     Background:~        -  Chromatin is is the structural building block of a chromosome. It is found inside the~          nucleus of the cell and consists of a complex of DNA and protein.~        -  Cancers of the lung, pleura (lung lining) and esophagus show profound changes in~          chromatin structure that may affect the course of disease in patients.~        -  A better understanding of these diseases and the genetic changes associated with them~          may be helpful in developing new treatments for them.~      Objectives:~        -  To evaluate people with cancer of the lung, pleura or esophagus for participation in NCI~          clinical trials.~        -  To obtain biopsies (small pieces of tissue) from tumor, normal tissue and blood samples~          to learn more about the cellular changes in blood and tissue in tumors of the lung,~          esophagus and pleura and surrounding structures in the chest.~      Eligibility: Patients 18 years of age and older with cancer of the lung, esophagus, pleura,~     mediastinum or chest wall, or cancers of other origin that have invaded the lung.~      Design:~        -  Up to 800 patients may be included in this study.~        -  Patients undergo standard tests for evaluating the stage of their disease and for~          determining eligibility for an NCI investigational treatment study.~        -  All patients undergo bronchoscopy and bronchoalveolar lavage (washing with salt water)~          to assess their tumor and collect a sample of normal tissue. Patients whose tumor is~          located on the outside portion of the lung may also undergo thoracoscopy to obtain a~          tumor sample. For bronchoscopy and bronchoalveolar lavage a tube with a light is passed~          through the nose or mouth into the lungs to examine the airways. Salt water is injected~          through the tube and then withdrawn to obtain cells for laboratory studies. For the~          thoracoscopy a small tube with a light is put through a small hole in the chest to~          obtain the tumor sample. Both procedures are usually done under general anesthesia. The~          tissue is examined to identify cell characteristics of people who respond to certain~          therapies and to identify markers on the surface of the tissue that may be useful in~          future research and treatment.~        -  Blood and urine samples are collected from patients.~        -  Patients who are eligible for a treatment study at NCI are offered participation in the~          study.~        -  Patients for whom standard surgery, radiation or chemotherapy is more appropriate may~          receive treatment at NCI or with their own physician.~        -  Patients who receive treatment at NCI return for follow-up examinations 4 weeks after~          discharge and then every 2 to 4 months depending on the nature of their cancer.~   "
252794|NCT00242710|"~     The purpose of this study is to determine whether bazedoxifene/conjugated estrogens~     combinations are effective for the prevention of endometrial hyperplasia and for the~     prevention of osteoporosis in postmenopausal women.~   "
252795|NCT00242697|"~     Use of neuraxial agents in anesthesia for cardiac surgery is expanding. We have used combined~     general-spinal anesthesia for cardiac surgery for 12 years. We hypothesized that compared to~     general anesthesia, the combined techniques would provide comparable intraoperative~     hemodynamics and improved postoperative analgesia. This study subjected these techniques to a~     double-blind randomized trial.~   "
252796|NCT00242684|"~     Background: There is tremendous controversy regarding the adequacy/effectiveness of the~     nutritional care provided in VA Transitional Care Units (TCUs). The interrelationship between~     concurrent inflammatory disease, the adequacy of a resident's nutrient consumption, the~     development or resolution of putative nutritional deficits, and clinical outcomes is not~     established. Given the known obstacles to increasing nutrient intake (e.g. cost, resident~     acceptance, associated morbidity) and the lack of proven effectiveness of all forms of~     nutrition support and nutritional supplementation to improve clinical outcomes, a better~     understanding of these interrelationships is needed and will be the focus of this study.~      Objectives: The primary objective of this study is to determine how best to define~     nutritional risk (i.e., risk for adverse clinical outcomes due to inadequate nutrient intake)~     among older VA TCU residents. As part of this objective, we will seek to develop a better~     understanding of the interrelationship between nutrient intake, weight change, serum~     concentration of albumins, health status/illness severity, and mortality. The secondary~     objective is to develop a prediction model for identifying which TCU residents are likely to~     have ongoing problems with low nutrient intake. The ultimate objective is to develop a~     clinically useful system to identify residents who are likely to benefit from specific~     interventions aimed at improving nutritional risk.~   "
252797|NCT00242671|"~     The twilight phase between being asleep and awake during recovery from anesthesia is a~     precarious time fraught with risks to the post-operative patient. Hyperventilation~     accelerates the elimination of inhaled anesthetics but reduces their CO2 blood concentrations~     which delays their resumption of spontaneous breathing. We previously showed that our method~     of hyperventilation without affecting the CO2 concentration--which we call IH--accelerates~     the rate of emergence from anesthesia with isoflurane. In this study we will study the effect~     of IH on the rate of emergence from Sevoflurane anesthesia.~   "
252798|NCT00242658|"~     This study will test the efficacy of providing primary care physicians and their patients~     with computer-tailored information, based on patients' responses to survey questions. The~     health education messages are designed to encourage patients to become physically active and~     to encourage physicians to counsel their patients about exercise.~   "
252799|NCT00242645|"~     To test whether or not giving patients information before their doctor visits changes the~     care they receive and what type of information is best to give before the doctor visit.~   "
252800|NCT00242632|"~     This research aims to explore the effectiveness of memantine (Namenda) in treating~     post-menopausal women between the ages of 50 and 65, who are at risk for cognitive decline.~     Memantine has already been shown to offer cognitive benefits to patients suffering from~     Alzheimer's disease, but it's potential for treating those at risk for cognitive decline~     without Alzheimer's disease or other dementia has yet to be evaluated. It is possible that~     memantine may offer neurocognitive benefits to this population, as well. Participants are~     asked to take medication for six months, complete neuropsychological testing, and one blood~     draw.~   "
252801|NCT00242619|"~     Insulin resistance is known to be associated with mood disorders and cognitive difficulties.~     The purpose of this study is to treat depressed patients with rosiglitazone (also known as~     [AKA] Avandia), therefore improving glucose sensitivity, which in turn has the potential to~     affect mood and thinking. We, the researchers at Stanford University, are recruiting men and~     women who have been diagnosed with depression, and are willing to participate in this 3 month~     study. Participation involves neuropsychological testing, 2 blood draws called an oral~     glucose tolerance test (OGTT), which tests for glucose and insulin levels, and the~     medication, rosiglitazone. Participants are allowed to continue on their current psychiatric~     medication.~   "
252802|NCT00242606|"~     The purpose of this study is to compare the efficacy, safety and tolerance of the drugs~     Lamotrigine and Levetiracetam in the initial monotherapy of patients with newly diagnosed~     epilepsy.~   "
252803|NCT00242593|"~     The purpose of this study is to determine the effects of the insulin-sensitizing medication~     rosiglitazone on attention and memory skills in older adults with mild cognitive impairment~     (MCI). The study also will examine the effects of this medication on brain structures that~     support memory and other thinking abilities, and on biological markers associated with~     inflammation, insulin resistance, and cardiovascular disease.~   "
252804|NCT00242580|"~     To evaluate the safety and efficacy of the combination treatments in wet age-related macular~     degeneration. The combination treatment consists of verteporfin photodynamic therapy and~     either triamcinolone acetonide or pegaptanib added as an intravitreal injection.~   "
252809|NCT00242515|"~     Primary Objectives:~      This a pilot project to determine the feasibility of the preemptive CD8+ depleted T-cell~     donor lymphocyte infusion (DLI) in:~        -  Reducing the incidence of graft versus host disease (GVHD) based on standard~          classification of acute and chronic GVHD~        -  Improving hte disease remission rate in comparison with our previous study results.~      Secondary Objectives:~        -  To investigate the impact of CD8+ depleted T-cell DLI in hematopoietic chimerism, and~          immunologic recovery of transplant patients.~   "
252810|NCT00242502|"~     The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks~     following initiation of therapy with the combination of Avastin and erlotinib in patients~     with unresectable hepatocellular carcinoma (HCC). Progression-free survival is defined as the~     time from initiation of therapy until documented disease progression or death.~      Secondary objectives include: response rate, median and overall survival, toxicity and~     tolerability, and to ascertain whether there is any correlation of response with prior~     treatment status and underlying HCC risk factor(s).~   "
252811|NCT00242489|"~     The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the~     treatment of osteoarthritis of the knee.~   "
252812|NCT00242476|"~     This study will assess the effectiveness of an investigational drug in elderly subjects with~     low vitamin D levels.~   "
252813|NCT00242463|"~     This prospective, double-blinded study will determine the feasibility of determining the~     efficacy of a weekly intramuscular injection of nandrolone (an anabolic steroid) in~     malnourished ICU patients.The data from this study will also enable us to prepare a future~     grant proposal with a calculated sample size necessary to demonstrate an improvement in~     clinical outcome.~   "
252814|NCT00242450|"~     During the first 7 days of life very small babies will receive the drug metoclopramide or a~     salt solution through an intravenous line. They will also begin to receive a very small~     amount of breast milk or formula within the first 72 hours of life, in addition toother~     nourishment that is provided by an intravenous line, according to standard hospital~     procedure. We think that the babies who receive the medication may reach full oral feeds than~     babies who receive the salt solution.~   "
252815|NCT00242437|"~     Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving~     hemostasis in patients undergoing endoscopic sinus surgery.~   "
252816|NCT00242424|"~     Study of the safety and immunogenicity (antibody producing capability) comparing inactivated~     influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive~     inactivated influenza vaccine at the same time as other vaccines on the routine immunization~     schedule. Infants will be randomized at enrollment to receive inactivated influenza vaccine~     or placebo at a 2:1 ratio. This study is double-blind, randomized, and placebo-controlled.~   "
252817|NCT00242411|"~     The purpose of the study is to compare the efficacy of a flexible dose of Symbicort~     (budesonide/formoterol) with conventional stepwise best standard treatment in patients with~     persistent asthma.~   "
252818|NCT00242398|"~     The purpose of this study is to determine the safety and operative efficacy of intermittent~     hemodialysis without anticoagulation with saline flushes or Nephral 400ST in patients at high~     risk of bleeding~   "
252819|NCT00242385|"~     The primary purpose of this study is to characterize the pharmacokinetic profile of~     intravenous Aralast Fraction (Fr.) IV-1, a sterile, stable, lyophilized preparation of~     functionally intact human Alpha1- Proteinase Inhibitor (α1-PI). This pharmacokinetic study~     will be a randomized controlled clinical trial with a cross-over design. Twenty-four subjects~     will be enrolled into the study. Overall study duration will be approximately 6-8 months.~   "
252820|NCT00242372|"~     This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of~     tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin~     (along or in combination with one or more oral antidiabetic agents in addition to diet and~     lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized,~     double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up.~     Patients must receive at least 30 units of insulin per day and will continue their current~     oral antidiabetic treatment regimen throughout the study.~   "
252821|NCT00242359|"~     Management of animal induced occupational asthma is mainly avoidance, but this is not~     feasible for many occupations. Treatment with avoidance and conventional treatment is also~     not always successful. Omalizumab is FDA approved for the treatment of allergic asthma and~     may be effective at reducing symptoms and disease progression in the animal handlers~     population.~   "
252822|NCT00242346|"~     The purpose of this study is to assess the effects of high doses of candesartan cilexetil and~     also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction~     of proteinuria.~   "
252823|NCT00242333|"~     The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237~     in patients with chronic obstructive pulmonary disease (COPD).~   "
252824|NCT00242320|"~     The aim of the study is to compare the effect of roflumilast on lung function in patients~     with COPD. Roflumilast will be administered orally once daily in the morning at one dose~     level. The study duration consists of a baseline period (4 weeks) and a treatment period (12~     weeks). The study will provide further data on safety and tolerability of roflumilast.~   "
252825|NCT00242307|"~     The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function~     in patients with asthma. Roflumilast will be administered orally once daily. The study~     duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The~     study will provide further data on safety, tolerability, and effectiveness of roflumilast.~   "
252826|NCT00242294|"~     The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function~     in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be~     administered orally once daily. The study duration consists of a baseline period (4 weeks)~     and a treatment period (24 weeks). The study will provide further data on safety,~     tolerability, and effectiveness of roflumilast.~   "
252827|NCT00242281|"~     The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg~     tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250~     mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the~     Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb)~     population.~   "
252829|NCT00242255|"~     This study will examine the role of epigenetics (heritable changes in gene function that~     occur without a change in DNA sequence) in the aging process. DNA is the primary genetic~     material, responsible for transmitting information from one cell to the next or from one~     generation to the next. A second layer of heredity is described by the term epigenetics.~      Epigenetic information is reset from one generation to the next. It works in two ways: 1) by~     modification of the DNA, like balloons stuck at irregular intervals onto the sides of the DNA~     helix that encodes genes, and 2) through specialized protein shells that wrap around some~     regions of DNA. As in DNA, these shells can copy themselves and can transmit instructions.~     Because they are used to turn genes on and off, errors in their settings cause critical~     misinformation to be transmitted.~      Aging involves many changes, such as muscle weakening, graying hair, skin wrinkling, and so~     forth. There are several current theories of aging, including damage to genes by oxidation,~     shortening of tiny structures at the ends of chromosomes called telomeres, and the ability to~     stretch lifespan with caloric restrictions. This study will investigate the possible role of~     epigenetics in aging by examining and comparing the shell-like epigenetic settings in skin~     cells in young adults and older individuals. Preliminary results from earlier studies show~     differences in these settings in younger and older people.~      Women between the ages of 21 and 30 years and 65 and 90 years who are undergoing breast~     reduction or mastectomy at Suburban Hospital in Bethesda, Maryland, may participate in this~     study. Tissue removed during surgery for pathological examination will also be used by~     researchers in this study to validate the preliminary findings noted above and to continue~     studies into the new area of epigenetics and aging.~   "
252830|NCT00242242|"~     This study will gain information on methods of control of a prosthetic arm in stroke patients~     or traumatic brain inury patients through a technique called brain-computer interface~     (BCI). BCI allows for direct communication between man and machine. Brain cells communicate~     by producing electrical impulses that help to create such things as thoughts, memory,~     consciousness and emotions. In BCI, brain waves are recorded by an electroencephalogram (EEG)~     through electrodes (small wires) attached to the scalp. The electrodes measure the electrical~     signals of the brain. These signals are sent to the computer, which translates them into~     device control commands as messages that reflect a person's intention. This type of brain~     activity comes from the sensorimotor areas of the brain and can be controlled through~     voluntarily training to control the hand prosthesis through the BCI.~      Healthy normal volunteers and people who have had a stroke or traumatic brain injury more~     than 12 months ago and have paralysis in the right or left arm, hand or leg and who are~     between 18 and 80 years of age may be eligible for this study. Candidates are screened with a~     clinical and neurological examination and magnetic resonance imaging (MRI) of the brain. MRI~     uses a magnetic field and radio waves to obtain images of the brain. The scanner is a metal~     cylinder surrounded by a strong magnetic field. During the procedure, the subject lies in the~     scanner for about 45 minutes, wearing ear plugs to muffle loud knocking sounds that occur~     with the scanning.~      Participants undergo the following procedures:~        -  Sessions 1-2: Participants are connected to an EEG machine and familiarized with the~          hand orthosis (training device used in the study) and the tasks required for the study.~        -  Sessions 3-4: Participants receive baseline transcranial magnetic stimulation (TMS) and~          fMRI. For TMS, a wire coil is held on the scalp. A brief electrical current is passed~          through the coil, creating a magnetic pulse that stimulates the brain. The subject may~          feel a pulling sensation on the skin under the coil and there may be twitching in~          muscles of the face, arm or leg. The subject may be asked to tense certain muscles~          slightly or perform other simple actions. The effect of TMS on the muscles is detected~          with small metal disk electrodes taped to the skin of the arms. fMRI is like a standard~          MRI (see above), except it is done while the patient performs tasks to learn about brain~          activity involved in those tasks.~        -  Sessions 5-8: Participants are asked to repetitively move their hand (patients'~          paralyzed hand; healthy volunteers' normal hand), tongue and leg in response to three~          sound tones. After ten trials, they are asked to imagine the same movements 50 to 100~          times while the EEG machine is recording brain activity.~        -  Sessions 9-14: Participants are trained in controlling the hand orthosis. The subject's~          hand is attached to the orthosis and asked to imagine that they are performing finger or~          hand movements. This continues until there is an 80-90 percent success rate in achieving~          hand movement.~        -  Sessions 15-16: Participants repeat TMS and fMRI for comparison before and after~          training with the hand orthosis.~        -  Sessions 17-28: Participants receive additional training with the hand orthosis device~          (as in sessions 5-8), focusing only on the hand and not other parts of the body.~        -  Sessions 29-30: Participants undergo repeat TMS and fMRI to compare with the effect~          following additional training with the hand orthosis.~        -  Sessions 31-32: Optional makeup sessions if needed because of scheduling problems.~      Participants are evaluated in the clinic after 3 months to see if they have benefited from~     the study.~   "
252831|NCT00242229|"~     To evaluate the overall safety and tolerability profile of two dose levels of DVS-233 SR~     during 6 months of open-label treatment in elderly outpatients with major depressive~     disorder.~   "
252832|NCT00242216|"~     Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be~     administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that~     both are effective in treatment of ARV-naïve HIV-infected people. This study was designed to~     demonstrate if a HAART regimen containing ATV/r is not inferior to a HAART regimen containing~     fAPV/r, in ARV-naïve patients over a 96-week period.~      This is a phase IV, single center, randomized, open label, 2-arm clinical trial in ARV~     therapy-naïve patients with HIV-1 RNA >1,000 copes/mL and CD4 cell count <350 cells/mm3.~     Patients will be randomized to receive tenofovir and emtricitabine plus either ATV (300mg qd)~     and ritonavir (100mg qd) or fAPV (1400mg qd) and ritonavir (200mg qd).~   "
252833|NCT00242203|"~     This study is designed to evaluate the impact of Zometa on clearance of bone marrow~     micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density;~     and quality of life in women undergoing treatment for locally advanced breast cancer.~   "
252834|NCT00242190|"~     This study will examine a proposed research treatment which evaluates the addition of~     oxaliplatin, a chemotherapy agent, to gemcitabine, another chemotherapy agent, and radiation~     therapy for the treatment of patients with pancreatic cancer. The researchers have already~     done studies using gemcitabine and radiation therapy together. They want to build on the~     information they have from this previous research. The researchers believe that the~     combination chemotherapy with radiation is worth investigating to treat pancreatic cancer.~     They will use this study to determine what type of side effects occur with this treatment and~     to assess how effective the treatment is at controlling the cancer.~   "
252835|NCT00242177|"~     The purpose of this study is to determine whether an already FDA approved drug is safe and~     tolerable in Relapsing Remitting Multiple Sclerosis patients.~   "
252836|NCT00242164|"~     The study is being performed to better understand dialysis techniques which keep heart~     functions stable during dialysis. People on dialysis have a high risk for heart disease and~     strokes. More information about dialysis techniques that keep hearts stable may help prevent~     the high risk of cardiovascular disease and death and help to reduce discomfort during~     dialysis. This study will look at the way that the magnesium in dialysate affects heart~     function during dialysis. High or low levels of magnesium may change the way hearts beat. The~     question asked is if lowering the amount of magnesium in dialysate will affect the amount of~     magnesium in blood or change the heart beat.~   "
252837|NCT00242151|"~     The objective of this study is to determine prevalence of postoperative delirium and~     confusion in patients undergoing cardiac surgery. This proposal is a pilot study designed to~     evaluate effect of cardiac surgery on prevalence of delirium and confusion.~      The primary aim is to evaluate prevalence of delirium and confusion in patients undergoing~     cardiac surgery and to determine risk factors for this condition.~      A secondary aim is to evaluate organic brain injury by early postoperative diffusion weighted~     magnetic resonance imaging (DW-MRI) in patients who develop delirium and confusion.~      The hypothesis to be tested is that patients with postoperative delirium and confusion have~     high incidence of organic brain injury as detected by DW-MRI.~   "
252838|NCT00242138|"~     The optimal duration of hormonal therapy is yet to be determined in the treatment of locally~     advanced carcinoma of the prostate. The RTOG performed a trial of 4 months of neoadjuvant and~     concurrent hormones(consisting of Goserelin and Flutamide) compared to radiation alone, and~     found that there was an improvement in local control and progression-free survival, but no~     improvement in overall survival. The EORTC performed a similar trial, but used Goserelin~     alone for a period of 3 years. This trial showed an improvement in local control,~     disease-free survival, and in contrast to the RTOG trial, an improvement in overall survival.~      The rate of erectile dysfunction in men who receive a prolonged period of Gosereline (i.e. 2~     yrs) is not known, but suspected according to expert opinion, to be significantly higher than~     a shorter course of hormonal ablation. Therefore the price of of a survival advantage in~     locally advanced prostate cancer maybe at a cost of increased rates of erectile dysfunction.~   "
252839|NCT00242125|"~     Primary biliary cirrhosis (PBC) is a chronic liver disease primarily affecting middle age~     women. It is characterized by immune-mediated damage to cells lining the tiny bile ducts~     within the liver. Although the underlying cause of PBC is likely to be multifactorial, the~     epidemiologic/population data indicate a very important role for genetic predisposition,~     meaning that the disease seems to run in families. Susceptibility genes for PBC have not been~     identified possibly due to limitations such as small sample size in prior studies. The~     primary objective of this study is to identify these genes. This study involves obtaining~     clinical and demographic data as well as collecting DNA samples from patients and their~     parents, and siblings to screen for a select set of candidate genes as well as the full~     genome for variants associated with PBC.~   "
252840|NCT00242112|"~     The purpose of this study is to determine the ability of functional MRI techniques to detect,~     measure and locate intra-prostatic cancer.~   "
252841|NCT00242099|"~     Human herpesvirus-6 (HHV-6) and -7 (HHV-7) infections are common after transplantation. Such~     infections may predispose transplant patients to other infections, contribute to a recurrence~     of hepatitis C virus, and affect rejection and function of the transplanted liver. Given the~     significant clinical impact of these viruses, routine laboratory monitoring may be beneficial~     by identifying patients who have persistent or high levels of infection. In these patients,~     immunosuppressive medications could be adjusted, or antiviral medications administered. There~     are currently no randomized trials that address this important question. This prospective,~     randomized trial will analyze whether routine laboratory monitoring for HHV-6 and -7 is~     clinically useful, and whether it would improve overall outcomes in transplant recipients.~   "
252842|NCT00242086|"~     The purpose of this study is to correlate the MRI CT and PET appearances of colorectal liver~     metastases to pathologic appearance ot better understand the accuracy of imaging to determine~     tumor size.~   "
252843|NCT00242073|"~     Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence~     the success of treatment and the progression of disease in prostate cancer. The method used~     to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself~     through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI~     technique that allows indirect assessment of oxygen levels in blood. This technique is~     non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer.~     The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively~     measure changes related to tumor hypoxia in prostate cancer. This technique may provide~     information that will be an independent predictor of patient survival, tumor recurrence and~     likelihood of treatment response in prostate cancer~   "
252844|NCT00242060|"~     Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate~     cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided~     biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated~     PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI~     using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and~     Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these~     patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100~     men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in~     the study.~   "
252845|NCT00242047|"~     An open label, randomized, controlled, equivalency trial to compare the efficacy of the~     percutaneous route of administration with the intradermal route of administration of Japanese~     (Tokyo) 172 BCG, in the prevention of tuberculosis during the first two years of life.~   "
252846|NCT00242034|"~     In cervix cancer tumor oxygen levels and fluid pressure in the tumor have been shown to be~     related to patient outcome. Analysis of the way tumors enhance after intravenous contrast~     injection using MRI and CT can be used to determine parameters that relate to tumor blood~     vessels. In this study we hope to determine if there is a relationship between the~     enhancement of cervix cancer on MRI and CT and tumor oxygen levels and interstitial fluid~     pressure. If such a relationship exists then it could help improve the care of patients wiht~     cervix cancer by allowing for more aggressive therapy of patients with cancer that have more~     ominous imaging characteristics~   "
252847|NCT00242021|"~     The objective of the study is to investigate the effect of fatty acid composition of a fat~     supplement:~        1. acutely (after single intake) on subjective and objective measurements of hunger,~          satiety and wellness, on energy intake, and postprandial hormonal changes;~        2. in the long-term (after one week) on (regulators of) fat tissue metabolism.~   "
252848|NCT00242008|"~     The purpose of this trial is to assess whether it is possible for subjects with idiopathic~     Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine~     transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms.~      Subjects who meet eligibility criteria will be switched overnight to treatment with~     rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine~     agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take~     their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next~     morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose~     of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose~     can be increased or decreased as needed. At the end of treatment, subjects can select to~     enroll in an open-label extension trial.~      The first subject was enrolled on 28 December 2004. The last subject was enrolled in June~     2005 and the last subject visit was conducted in July 2005. This study is now closed.~   "
252849|NCT00241995|"~     The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate,~     lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome~   "
252850|NCT00241982|"~     Trial to study the safety of a single, intravenous administration of long-circulating~     liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.~   "
252851|NCT00241969|"~     The primary objective of this NIH funded clinical trial is to conduct a multi-center,~     randomized, controlled trial comparing two interventions: a behavioral plus nutrition~     intervention to a nutrition intervention. This study will (a) determine the impact of the~     behavioral intervention on energy intake and weight gain; (b) examine the durability of the~     behavioral intervention's impact on growth (weight and height) one year following treatment;~     and (c) explore the relation between physical activity and growth.~   "
252852|NCT00241956|"~     To assess whether patients with diabetes have less clinical improvement during inpatient~     rehabilitation than those without diabetes and whether hyperglycaemia during rehabilitation~     is an adverse prognostic indicator.~   "
252853|NCT00241943|"~     The investigators hypothesize that a well-designed hepatitis C (HCV) video education~     curriculum for active drug injectors will lead to measurable improvements in HCV testing~     rates, HAV and HBV vaccination rates, as well as knowledge and attitudes about this~     condition. The investigators will use a short 10 minute video designed for active drug users~     to and assess its impact vs. a usual-care counseling intervention. The investigators will~     measure and compare its impact at baseline, 4 weeks after video viewing, and 12 weeks after~     intervention.~   "
253014|NCT00239772|"~     This study will evaluate the effectiveness of cognitive processing therapy versus prolonged~     exposure therapy in treating women with post-traumatic stress disorder (PTSD) brought on by~     sexual assault.~   "
252854|NCT00241930|"~     We hypothesize that integrating drug treatment into HIV treatment will improve HIV outcomes~     as well as drug treatment outcomes in heroin users. This study will test this hypothesis by~     randomizing patients to two groups. The first group will receive HIV treatment and~     buprenorphine treatment contemporaneously at their HIV clinic. The second group will receive~     HIV treatment at their HIV clinic, and go to another facility to receive buprenorphine~     treatment services.~      We will look at HIV outcomes such as CD4 counts, HIV viral loads, and attendance at~     appointments and drug treatment outcomes such as receipt of buprenorphine and urine~     toxicology testing.~   "
252855|NCT00241917|"~     The investigators hypothesize that a well-designed hepatitis C (HCV)video education~     curriculum for high-risk drug users will show measurable benefits in improving HCV testing,~     hepatitis A and B vaccinations, and HCV knowledge, attitudes, and motivations toward~     transmission behavior change. The investigators will use a 4-part modular video series~     designed for at-risk drug users, and in this 12 week study will assess its impact on~     testing/vaccinations as well as knowledge, attitudes, and motivations in methadone-maintained~     drug users as compared to a usual-care intervention.~   "
252856|NCT00241904|"~     PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON~     FAMILY HEALTH CENTER.~      The purpose of this study is to compare the clinical effectiveness and cost effectiveness of~     two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with~     a less intensive (LI) intervention - in African American, and white low-income patients with~     known excessive cardiovascular disease risk.~   "
252857|NCT00241891|"~     This study will train primary care providers to counsel families on behavior change that is~     aimed at reducing the rate of weight gain in at-risk children.~   "
252858|NCT00241878|"~     The purpose of this study is to compare changes in body mass index (BMI) among 3- to~     5-year-old minority children randomized to a weight control intervention (WCI) or a general~     health control intervention.~   "
252859|NCT00241852|"~     The purpose of this study is to test two asthma management programs: (a) a school-based~     curriculum to empower middle school students to manage their asthma and (b) a parent training~     curriculum to teach childrearing skills that support the youths' growing autonomy and need to~     self-manage their disease.~   "
252860|NCT00241839|"~     This study will test the hypothesis that the administration of a xanthine oxidase inhibitor~     (allopurinol) will prevent thiazide-induced hyperuricemia, which will result in better blood~     pressure (BP) control in African Americans.~   "
252861|NCT00241826|"~     The purpose of this study is to determine the diagnostic accuracy of gadolinium-enhanced~     magnetic resonance angiography (Gd-MRA) of the pulmonary arteries in combination with~     magnetic resonance venography (MRV) of the veins of the thighs in patients with clinically~     suspected acute pulmonary embolism (PE).~   "
252862|NCT00241813|"~     This study will examine the effects of two behavioral stress reduction programs, mindfulness~     meditation (MM) and the lifeskills program (LP), and a health education control program (CTL)~     on blood pressure.~   "
252863|NCT00241800|"~     To investigate a potential relationship between four different classes of non-cardiovascular~     drugs and the risk of sudden cardiac death.~   "
252864|NCT00241787|"~     To determine the rate of progression of sub-clinical cardiovascular disease as measured in~     carotid intimal medial thickness over a period of 8 to 10 years.~   "
252865|NCT00241774|"~     To examine the associations among depression, inflammation, and coronary heart disease using~     an existing data base and associated plasma samples.~   "
252866|NCT00241761|"~     To understand how depression leads to congestive heart failure (CHF) in older adults.~   "
252867|NCT00241748|"~     To conduct a case-control study of factors that increased the risk of rhabdomyolysis, an~     adverse drug reaction in cerivastatin users~   "
252868|NCT00241735|"~     To investigate whether soy food intake reduces risk of non-fatal myocardial infarction (MI)~     and fatal coronary heart disease in Chinese women.~   "
252869|NCT00241722|"~     Adults who are taking opioid therapy for persistent non-cancer pain and have resulting~     opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The~     primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo~     for safety and tolerability in the treatment of OBD. Participants will be required to attend~     8 clinic visits over approximately 1 year.~   "
252870|NCT00241709|"~     The purpose of this study is to examine the effectiveness of approaches to correct for the~     effects of population stratification on case-control genetic association studies.~   "
252871|NCT00241696|"~     To examine air pollution, inflammation and new onset asthma in a large cohort of children in~     southern California.~   "
252872|NCT00241683|"~     To determine whether or not women with a history of having a baby with intrauterine growth~     retardation (IUGR) was more likely to have risk factors for cardiovascular disease versus~     women with a pregnancy not complicated by IUGR.~   "
252873|NCT00241670|"~     The aim of the study Fluorescence-guided resection of malignant gliomas with~     5-Aminolevulinic acid (5-ALA) vs. conventional resection is to determine how accurately~     contrast agent-accumulating tumour can be removed by primary surgery and to assess the~     clinical usefulness of this method.~   "
252874|NCT00241657|"~     BCG vaccination has been found to provide greater protection against TB in the UK than in~     Malawi. This study compares immune responses in BCG-vaccinated and unvaccinated teenagers and~     young adults in Malawi and in the UK.~   "
252875|NCT00241644|"~     The primary objective of this study is to determine if the GSK Biologicals' human rotavirus~     (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on~     immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the~     20-point Vesikari scoring system [Ruuska, 1990]) caused by the circulating wild-type RV~     strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until~     Visit 5.~      The primary objective will be reached if the lower limit of the 95% confidence interval (CI)~     on vaccine efficacy is >0%.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
252898|NCT00241345|"~     The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is~     as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as~     determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have~     undergone bone marrow or peripheral blood stem cell transplant.~   "
252876|NCT00241631|"~     The global burden of COPD − a common and debilitating chronic inflammatory disease that is~     characterised by the progressive development of airflow limitation (shortness of breath −~     SOB) and is poorly reversible with currently available drugs −is increasing. Cigarette~     smoking is strongly linked with the ongoing inflammation; inflammation that can continue even~     when the patient has stopped smoking. The severity of airflow limitation (SOB) is correlated~     with the degree of pulmonary (lung) inflammation.~      Histone deacetylases (HDACs)are important molecules in suppressing this pulmonary~     inflammation. We have recently shown that patients with COPD have a reduction in total HDAC~     which correlates with the severity of their lung disease.~      Corticosteroids (anti−inflammatory treatment) act, at least in part, by recruitment of these~     HDACs to the site of active inflammatory gene transcription (which reduces the production of~     inflammatory molecules) and are widely used in COPD in patients with severe disease.~     Unfortunately, in COPD, inhaled corticosteroids seem to have little effect on the underlying~     inflammation (though in a selective group of patients with COPD they do reduce the number of~     infections a patient may have by a small amount). Theophylline has been used in the treatment~     of asthma and COPD for over 70 years, but its use has recently declined. Data so far obtained~     in primary cells (cells from patients used in the laboratory) from COPD patients suggests~     that low dose theophylline (~5mg/l) should be effective in restoring steroid sensitivity in~     patients with COPD (and hence reduce inflammation thus improving SOB). We wish therefore to~     continue these studies on theophylline principally by conducting a small clinical pilot study~     on 20−30 COPD patients in a randomised, double−blind, placebo−controlled, parallel−group~     study.~   "
252877|NCT00241618|"~     Spontaneous resolution of acute hepatitis C infection cannot be predicted and the majority of~     cases persist and become chronic. This randomized trial assesses the efficacy and safety of~     peginterferon alfa-2b. The investigators hypothesize that therapy strategies could prevent~     the development of chronic hepatitis.~   "
252878|NCT00241605|"~     This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control~     in patients with Type 2 Diabetes Mellitus.~   "
252879|NCT00241592|"~     A study to evaluate the use of a vaporization system as a smokeless delivery system for~     inhaled marijuana.~   "
252880|NCT00241579|"~     The purpose of this study is to determine whether or not inhaled marijuana displays any~     pain-relieving properties on experimentally-induced pain.~   "
252881|NCT00241566|"~     All neuropathic chronicle pains are difficult to treat. Currently many patients are not~     relieved by electric stimulations of central nervous system, existing. Recently cortical~     stimulation had a development important and benefit effects are proven. In this study we~     evaluate medico-economic impact of this treatment.~   "
252882|NCT00241553|"~     This study was a multicentre, double-blind, randomised, placebo-controlled parallel group~     study consisting of 4 visits over a period of 6 months. The primary variable was to assess~     theefficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20)~     versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper~     GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients~     receiving daily NSAID therapy.~   "
252883|NCT00241540|"~     This study is a randomised, double-blind, parallel-group and placebo controlled study~     comparing the efficacy of esomeprazole 40 mg orally qd vs. placebo and esomeprazole 20 mg~     orally qd vs. placebo when given to patients on continuous use of NSAIDs, including COX-2~     selective NSAIDs, for a period of 4 weeks in treatment of relief of upper GI symptoms.~   "
252884|NCT00241527|"~     This study was a randomised, double-blind, parallel-group and placebo controlled study~     comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg~     orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2~     selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.~   "
252885|NCT00241514|"~     This study was a multicentre, double-blind, randomised, placebo-controlled parallel group~     study consisting of 4 visits over a period of 6 months. The primary variable was to assess~     the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20)~     versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper~     GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients~     receiving daily NSAID therapy.~   "
252886|NCT00241501|"~     This study is a phase III, multi-centre, randomized, double-blind study to assess the safety~     and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and~     adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The~     treatment period will be up to 8 weeks.~   "
252887|NCT00241488|"~     This clinical trial is being performed to investigate the effect of 12 weeks treatment with~     rosuvastatin and atorvastatin in bringing subjects to their established EAS LDL-C target~     goal.~   "
252888|NCT00241475|"~     To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA~     response rate at study closure~   "
252889|NCT00241462|"~     The purpose of this study is to identify which patients, receiving Faslodex within the~     approved label, benefit most from Faslodex treatment.~   "
252890|NCT00241449|"~     The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex~     (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer.~     Patients will be treated until disease progression or until the investigator has determined~     that treatment is not in the best interest of the patient, whichever occurs first.~   "
252891|NCT00241436|"~     The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and~     pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.~   "
252892|NCT00241423|"~     The purpose of this study is to test the hypothesis that in patients with type 2 diabetes,~     the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour~     period, compared with placebo.~   "
252893|NCT00241410|"~     Safety and tolerability of different dose combinations of MPL and grass pollen allergen and~     to identify the highest combinations of MPL and grass pollen allergen which is safe.~      Pharmacodynamics and efficacy of MPL and grass pollen allergen.~   "
252894|NCT00241397|"~     The purpose of this study is to assess the prevalence of Major Depression and/or Anxiety~     Disorder in patients consulting the General Practitioner with acute or chronic painful~     physical symptoms and to identify risk factors.~   "
252895|NCT00241384|"~     The primary purpose of this study is to evaluate two treatment regimens for prostate cancer,~     prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0~     Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate~     cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external~     beam radiation therapy as their intended treatment will be eligible and will be offered~     participation.~   "
252899|NCT00241332|"~     The aim of this trial is to examine the possibility that fentanyl 1,5 µgr/kg given~     intravenously (i.v.) before the start of remifentanil infusion for anesthesia gives less~     development of tolerance/hyperalgesia postoperative than fentanyl given at the end of surgery~     (the traditional method).~   "
252900|NCT00241319|"~     The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution~     compared with placebo in alleviating the signs and symptoms of conjunctival allergen~     challenge-induced allergic conjunctivitis~   "
252901|NCT00241306|"~     The purpose of this study is to determine whether gender and age modify cerebral activations~     during a silent word generation functional Magnetic Resonance task.~   "
252902|NCT00241293|"~     The purpose of this study is :~        -  to look for changes induced by aging in a population of old subjects, during silent word~          generation tasks studied by fMRI.~        -  to look for a possible link between these changes and alterations in language~   "
252903|NCT00241280|"~     Study in the US intended to evaluate the safety and effectiveness of a Johnson & Johnson~     Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6~     nights).~   "
252904|NCT00241267|"~     The exploration of neoplastic pulmonary pathology is based on computed tomography and~     bronchoscopy. This allows targeted samples of the identified lesions.~      A new ultrasonographic method is proposed as a non invasive and non irradiating technic by~     using a dedicated probe easily introduced via the channel of the fibrescope, so as to~     complete the identification of peripheral lesions.~   "
252905|NCT00241254|"~     Preliminary not-controlled clinical studies of the efficacy of monthly intravenous~     cyclophosphamide administration in secondary progressive multiple sclerosis reported~     encouraging results, but no randomized controlled trial has been conducted so far. The~     primary objective of this trial is to evaluate the efficacy of IV cyclophosphamide as~     compared to IV methylprednisolone administered every 4 weeks during 1 year and every 8 weeks~     during 1 year, on the delay to confirmed disability deterioration as assessed by the Expanded~     Disability Status Scale (EDSS) in patients with secondary progressive multiple sclerosis. The~     secondary objectives are to evaluate safety, tolerability and efficacy at 2 years on the~     Multiple Sclerosis Functional Composite (MSFC), the percentage of patients with disability~     deterioration (EDSS) and the number of relapses. An intention-to-treat statistical analysis~     will be carried out.~   "
252906|NCT00241241|"~     Interferon alfa is an effective treatment of polycythemia vera (PV), but about 20% of~     patients discontinue their treatment because of side effects and treatment schedule (three~     times per week administration). The pegylated form of interferon alfa-2a has shown a better~     tolerance in hepatitis patients and is administered only once a week. The purpose of this~     study is to determine efficacy and safety of pegylated interferon alfa-2a in the treatment of~     PV patients.~   "
252907|NCT00241228|"~     Sepsis and septic shock are still important causes of mortality in intensive care medicine.~     Renal replacement therapy by standard volume haemofiltration is currently used, but a~     higher-volume haemofiltration may improve the prognosis. The study is a prospective~     randomized multicenter trial comparing two treatments in patients suffering from septic shock~     complicated with acute renal failure admitted to ICU. One group will be treated by early high~     volume haemofiltration (70 ml/kg/h) and the second group by standard volume haemofiltration~     (35 ml/kg/h). The main outcome will be one-month mortality.~   "
252908|NCT00241215|"~     Several studies have previously examined the use of botulinum toxin serotype A for myofascial~     pain of the neck and shoulders (cervicobrachial syndrome). These studies have suffered from:~        1. inclusion of confounding conditions in the proband group, and~        2. inability to identify predictors of response.~      This study attempts to define the characteristics of responders to botulinum serotype A for~     myofascial pain of the neck and shoulders (cervicobrachial syndrome).~   "
252909|NCT00241202|"~     The goals of this research are: 1) To test the efficacy of a self-care symptom management~     manual by examining whether people who use the manual find it to be useful; 2) To examine~     symptom and demographic data related to self-care behaviors, symptom control, medication~     adherence and enhanced quality of life.~      The University of California, San Francisco is the coordinating site for this multi-site~     international study.~   "
252910|NCT00241189|"~     This is a study to determine the safety of the immunosuppressive rapamycin in patients with~     systemic sclerosis with diffuse cutaneous scleroderma. The effects (both good and bad) are~     being compared to another group of systemic sclerosis patients receiving methotrexate~   "
252911|NCT00241176|"~     The purpose of this study is to determine if Abilify will reduce tics (repetitive,~     uncontrollable movements or vocalizations) in children and adolescents ages 7-18 with~     Tourette's Disorder (TD) or a chronic motor tic disorder (either repetitive, uncontrollable~     movements or vocalizations).~   "
252912|NCT00241163|"~     The overall objective is to compare efficacy and safety of TachoComb S and standard surgical~     treatment for the control of local bleeding in patients undergoing surgical resection of~     renal tumours. Specific objectives include the comparison between test treatments of~     intra-operative haemostatic efficacy as well as post-operative blood loss, haematoma~     formation, and surgeon's rating of usefulness of test treatment.~   "
252913|NCT00241150|"~     A STUDY ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE~     PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS).~   "
252914|NCT00241137|"~     The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of~     blood pressure reduction in a patient population of mild to moderate hypertensives~   "
252915|NCT00241124|"~     A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the~     morning and comparing a morning dose of Valsartan with an evening dose.~   "
252916|NCT00241111|"~     Study to determine effectiveness and safety of zoledronic acid and whether it has a~     pharmaco-economic impact in prostate cancer with bone metastasis.~   "
252917|NCT00241098|"~     This is a study to evaluate the response of patients with hypertension and early stage heart~     failure to valsartan.~   "
252918|NCT00241085|"~     This is a study of whether valsartan affects levels of proteinuria in patients with type 2~     diabetes and hypertension.~   "
252919|NCT00241072|"~     THE PURPOSE OF THIS STUDY IS TO DETERMINE IF 24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG -~     320 MG) IMPROVES INSULIN SENSITIVITY IN SUBJECTS WITH HIGHER THAN NORMAL GLUCOSE LEVELS USING~     A TEST CALLED THE EUGLYCEMIC CLAMP.~   "
252920|NCT00241059|"~     The objective of this extension study is to allow patients being treated with enteric-coated~     mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to~     assess the long-term safety of EC-MPS.~   "
252921|NCT00241046|"~     The course of the disease in female patients with metastatic mammary carcinoma can vary~     greatly. In this connection, the individual prognosis depends on a complex interaction of~     tumor- and patient-related factors. To take account of such differences, it is necessary to~     employ individual methods of treatment which are suited to the course of each patient's~     disease. Prof. Possinger and Dr. Schmid (Charite Berlin) and Prof. Wischnewsky (University of~     Bremen) have developed an approach that can help to achieve this goal with the aid of~     computerized machine learning techniques (MLT).~      The use of machine learning methods can be beneficial in oncology in two respects. On the one~     hand, an attempt can be made to individually estimate clinically relevant parameters like,~     for example, the recurrence probability or expected survival time as precisely as possible~     based on the established prognostic factors. And on the other hand, it may be possible with~     the aid of MLT to understand structural relationships between the clinical result and~     measured or established tumor-/patient-related variables.~      To analyze the possible benefits of machine learning techniques for patients with metastatic~     breast cancer, the aim of study FEM-D-2 is to investigate whether it is possible to~     characterize those patients who either do or do not respond to a specific treatment with a~     precision of 90%, prospectively estimate the time until worsening of the disease under a~     given treatment, and classify patients in groups with favorable and poor chances of~     medium-term survival.~      The use of inductive learning algorithms with machine learning also makes it possible to very~     accurately estimate the time until progression of the tumor growth. In patients who respond~     to letrozole therapy, the time until tumor progression depends on factors like pain, age,~     body mass index, disease-free interval, main localization of metastatic spread, and response~     to previous estrogen therapy. Only very minimal differences are found when comparing the~     actual time until progression of the disease and that calculated by the system (at least for~     survival times < 1 year). Furthermore, using machine learning techniques it has become~     possible to use initial data assessed before a letrozole treatment to estimate the survival~     time and distinguish patients with a high risk of dying soon from other patients with a more~     favorable prognosis.~   "
252922|NCT00241020|"~     Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an~     increasing incidence in industrialized countries. For patients with advanced HCC no efficient~     treatment is currently available. The objective of this study is to assess the efficacy and~     safety of octreotide in patients with advanced hepatocellular carcinoma.~   "
252923|NCT00241007|"~     SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301~   "
252924|NCT00240994|"~     The purpose of this study is to evaluate the safety of alemtuzumab after kidney~     transplantation as part of a multitherapy regimen to prevent kidney graft loss and death and~     to avoid steroids and chronic use of calcineurin inhibitors in pediatric renal transplant~     recipients 1 to 20 years of age.~   "
252925|NCT00240981|"~     The purpose of this study is to determine whether testosterone replacement in older men with~     low testosterone levels will increase muscle strength, improve physical performance and~     overall sense of well being, and reduce fatigue.~   "
252926|NCT00240968|"~     The purpose of this study is to determine whether a third dose of vaccines containing~     A/Vietnam/1203/04 provides more immunity than two doses. Subjects who participate in this~     study will have participated in DMID protocol 04-063 involving the A/Vietnam/1203/04. In this~     study, each subject will be asked to receive a third dose of the H5 vaccine at the same level~     administered in protocol 04-063. Subjects will be asked to record oral temperature and any~     experienced side effects for 7 days following the vaccine. Study procedures will include up~     to 3 blood sample collections. Participants will be involved in study related procedures for~     up to 6 months.~   "
252927|NCT00240955|"~     The objective of this study is to assess the long-term safety and tolerability of EC-MPS on~     the patients who completed the core study and wish to continue treatment on EC-MPS.~   "
252928|NCT00240942|"~     Endometriosis is a condition in which abnormal growth of tissue histologically resembling the~     lining of the uterus (endometrium) is present outside of the uterus. This study will~     investigate the effect of a daily dose of letrozole compared to GnRH is safe and in addition~     effective in reducing measurable endometriosis lesions and in reducing pain in patients with~     active endometriosis which were pretreated with GnRH analogs for 2 months.~   "
252929|NCT00240929|"~     A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of~     the following treatment sequence A or B.~   "
252930|NCT00240916|"~     This is an immunogenicity study evaluating the development of the immune response of healthy~     infants following primary vaccination with Attenuvax at 6 or 9 months of age compared with~     responses in 12 month-old infants receiving MMR-II. Responses of infants receiving an early~     two dose measles vaccine regimen with the first dose given at 6 or 9 months followed by a~     second dose administered at 12 months will also be compared to infants given a single dose at~     12 months of age (Table 2). The current approved regimen for measles vaccination is a first~     vaccination at 12-15 months and a subsequent vaccination at school entry.~      A secondary endpoint of this study will be to assess the safety of measles vaccine~     administered as Attenuvax at 6 or 9 months of age and in an early two dose measles vaccine~     regimen with Attenuvax administered at 6 or 9 months followed by MMR-II at 12 months of age.~   "
252931|NCT00240903|"~     The purpose of this study is to determine whether having received an H5 vaccine in the past~     primes the immune system to respond rapidly to another dose of H5 vaccine. One hundred~     seventeen participants in a previous vaccine study (involving the A/Hong/Kong/97 virus)~     during the fall of 1998 at the University of Rochester will be eligible to enroll in this~     study. Participation in this study will up to 64 days and will involve donation of small~     samples of blood 7, 28, and 56 days after vaccination.~   "
252932|NCT00240877|"~     To assess the safety of a vaccine in healthy adults prior to the release of the trivalent~     vaccine (FluMist).~   "
252933|NCT00240864|"~     The purpose of this study is to determine the onset of pain relief from a single dose of~     acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the~     surgical extraction of at least three molars.~   "
252934|NCT00240851|"~     The purpose of this study is to compare the effectiveness of acetaminophen extended release~     caplets to placebo in treating the muscle aching and pain (soreness) that occurs after a~     marathon.~   "
252935|NCT00240838|"~     The purpose of this study is to compare the effectiveness and safety of acetaminophen~     extended release caplets and ibuprofen in relieving the muscle soreness that occurs after a~     marathon.~   "
252936|NCT00240825|"~     The purpose of this study is to determine the onset of pain relief from a single dose of~     acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the~     surgical extraction of at least three molars.~   "
253015|NCT00239759|"~     The goal of MIRAGE is to evaluate the association of genetic and non-genetic risk factors for~     Alzheimer's Disease.~   "
252937|NCT00240812|"~     The purpose of the study is to determine if ibuprofen in combination with pseudoephedrine HCl~     in the treatment of nightime bedwetting in children is more effective than each drug alone~     and if the individual drugs are more effective than placebo.~   "
252938|NCT00240799|"~     The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day)~     compared to placebo for safety and effectiveness in the relief of signs and symptoms of~     osteoarthritis of the hip or knee over 12 weeks~   "
252939|NCT00240786|"~     The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg~     acetaminophen extended release given three times a day for the relief of signs and symptoms~     of osteoarthritis of the hip or knee for a period of 12 weeks.~   "
252940|NCT00240773|"~     The purpose of this study is to compare the long-term safety and effectiveness of~     acetaminophen (4000 mg per day) and naproxen (750 mg per day) in the treatment of~     osteoarthritis of the hip or knee.~   "
252941|NCT00240760|"~     This is a study to assess whether memantine is effective and safe in preventing age related~     cognitive deterioration and dementia in people with Down's syndrome (DS) age 40 and over. The~     study will last for a year and it will include 180 people with Down's syndrome with and~     without dementia. Participants will be assessed on memory skills, attention and problem~     solving abilities. Quality of life and abilities for everyday living skills will also be~     regularly checked.~      Primary Aims~      Clinical:~        -  To determine the clinical efficacy of memantine versus placebo in preventing cognitive~          decline in people with DS.~        -  To compare the safety and tolerability of memantine versus placebo in people with Down’s~          syndrome (DS).~      Biochemical and pathological:~        -  To examine the ability of memantine to alter markers of disease progression in DS~          patients.~      Secondary Aims~      Clinical:~        -  To determine whether memantine has, as compared with placebo, a significant positive~          impact on:~             -  level of independent functioning as measured by the carer-rated adaptive~               behavioural scale, (ABS) in adults with DS;~             -  quality of life in adults with DS.~      Biochemical and pathological:~        -  To investigate putative markers of memantine’s mechanism of action in peripheral samples~          from living patients with DS.~   "
252942|NCT00240747|"~     Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid~     (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population~     pharmacokinetics of Synercid in pediatric patients and to collect additional safety and~     efficacy data in pediatric patients.~   "
252943|NCT00240734|"~     The purpose of this study is to compare the proportion of subjects receiving either Epoetin~     alfa (PROCRITÂ®) or placebo who are able to achieve a hemoglobin response, defined by at~     least a 1 gram/deciliter increase from baseline by Week 17.~   "
252944|NCT00240721|"~     The primary purpose of this study is to evaluate the effectiveness and safety of topiramate~     compared with placebo in the treatment of acute manic or mixed episodes in patients with~     Bipolar I Disorder.~   "
252945|NCT00240708|"~     The purpose of this study is to evaluate the effectiveness and safety of risperidone,~     formulated as a long-acting injectable drug, compared with risperidone tablets in the~     treatment of patients with schizophrenia.~   "
252946|NCT00240695|"~     The purpose of this follow-up study is to assess the long-term safety and tolerability of~     galantamine in individuals with mild cognitive impairment who participated in a previous~     study with galantamine~   "
252947|NCT00240682|"~     The purpose of this study is to determine whether cetuximab is effective in the treatment of~     locally advanced or metastatic squamous cell carcinoma of the skin expressing EGFR.~   "
252948|NCT00240669|"~     Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial~     massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates.~      Secondary objective :~        -  To evaluate the resorbable device ergonomy versus Titanium.~        -  To evaluate the clinical tolerance of resorbable device versus Titanium.~      Hypothesis :~      Osteosynthesis with resorbable device demonstrates a non inferiority success probability~     regarding the success observed in osteosynthesis with Titanium, with a less important~     probability of re-operation.~      Study duration : 14 months for each patient.~      Study treatment :~        -  Group I : Resorbable device PLLA/PGA.~        -  Group II : Titanium device.~      Study visits :~      - Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day~     45(Traumatology)/Day 90 (orthognatic) – Month 6,12 and 14.~      Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or~     orthognatic criteria.~   "
252949|NCT00240656|"~     The purpose of this study is to determine whether a larger dose of the aldosterone antagonist~     spironolactone combined with an ACE inhibitor (captopril) and a beta-blocker (carvedilol) is~     effective in reverse pulmonary artery remodeling in patients with pulmonary arterial~     hypertension (PAH)secondary to congenital heart disease~   "
252950|NCT00240643|"~     This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323~     in a relevant population. The data from this study will be used along with other data to aid~     in choosing the most appropriate dose for the later phase study.~   "
252951|NCT00240630|"~     The purpose of this study is to determine the consistency of response for Treximet~     (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine~     attacks at the mild pain phase and within 1 hour of onset of head pain.~   "
252952|NCT00240617|"~     The purpose of this study is to determine the consistency of response for Treximet (formerly~     known as Trexima) when treating four acute migraine attacks at the mild pain phase and within~     1 hour of onset of head pain.~   "
252953|NCT00240604|"~     Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim~     of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent~     glucose intolerance in patients treated with corticosteroids.~   "
252973|NCT00240344|"~     The purpose of this study is to determine the efficacy of Crestor in high risk patients~     switched from higher doses of other statins in obtaining the new European Atherosclerosis~     Society (EAS) low-density lipoprotein cholesterol (LDL-C) guidelines.~   "
252974|NCT00240331|"~     The purpose of this study is to see if rosuvastatin helps to reduce the number of heart~     attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.~   "
252975|NCT00240318|"~     The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the~     atherosclerosis (fatty deposits) in your arteries~   "
252954|NCT00240591|"~     This is a study for the long-term follow-up of patients who completed at least two years of~     follow-up after treatment with Tositumomab and/or Iodine I 131 Tositumomab (BEXXAR)on Study~     RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004 or CP-97-012. All patients will be assessed for~     survival and disease status, including subsequent therapy for NHL, and for long term safety.~     Laboratory evaluations consisting of a TSH level (for all patients) and a complete blood cell~     (CBC) count with a differential and platelet count (for patients in continuing response only)~     will be obtained annually through Year 10 post treatment with Tositumomab and/or Iodine I 131~     Tositumomab.~      Patients that remain in response to their previous treatment with BEXXAR, will additionally~     be followed radiographically for response and progression.~   "
252955|NCT00240578|"~     This is a multi-center study for the long-term follow-up of surviving patients who are~     expected to complete or who have completed at least two years of follow-up after treatment~     with Iodine I 131 Tositumomab (BEXXAR) on Studies CP-97-011, CP-98-025, CP-99-032, or~     CP-99-036. All patients will be assessed for survival and disease status, including~     subsequent therapy for NHL, and for long-term safety. Additionally Laboratory evaluations~     consisting of a TSH level and a complete blood cell (CBC) count with a differential and~     platelet count will be obtained annually. Additionally, patients who remain in long-term~     response following Iodine I 131 Tositumomab treatment will be followed for response and~     progression.~   "
252956|NCT00240565|"~     This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab~     in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following~     treatment with rituximab.~   "
252957|NCT00240552|"~     This open-label study will enable HIV-infected adults with limited treatment options to~     receive fosamprenavir until commercial supplies are available in Switzerland.~   "
252958|NCT00240539|"~     This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs)~     antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the~     study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up~     study.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
252959|NCT00240526|"~     To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after~     administration of the first dose of the study vaccine. The Protocol Posting has been updated~     in order to comply with the FDA Amendment Act, Sep 2007.~      No additional subjects will be recruited during this long-term follow-up study and no vaccine~     will be administered.~   "
252960|NCT00240513|"~     The use of oral antibiotics alone to treat inflammatory acne provides little to no long term~     therapeutic benefit.~      Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with~     minocycline, thereby increasing the therapeutic effect of the oral antibiotic.~   "
252961|NCT00240500|"~     The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen~     (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of~     the study vaccine. The Protocol Posting has been updated in order to comply with the FDA~     Amendment Act, Sep 2007.~   "
252962|NCT00240487|"~     This research project is an open-label, randomized study for the use of Nitric Oxide in~     pediatric patients with acute respiratory distress syndrome (ARDS). The study examines~     whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of~     oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal~     of the study is to evaluate whether the order of NO therapy will have any effect on response,~     and evaluate the characteristics of patients who respond to NO compared to those who do not.~   "
252963|NCT00240474|"~     The primary objective of this study was test non-inferiority of telmisartan 80 mg +~     hydrochlorothiazide (HCTZ) 12.5 mg in comparison to amlodipine 10 mg + HCTZ 12.5 mg in~     reducing ambulatory systolic blood pressure (SBP) in the last 6 hours of the 24-hour dosing~     interval (determined by ambulatory blood pressure monitoring: ABPM) in elderly patients with~     predominantly systolic hypertension.~   "
252964|NCT00240461|"~     Seniors are a population vulnerable to respiratory infections. It is hypothesized that~     regular use of COLD-fX following an influenza vaccination would potentially augment immune~     response in the elderly. Use of COLD-fX may also provide additional protection again~     respiratory infection and reduce the incidence and severity of respiratory infections in~     otherwise healthy seniors.~   "
252965|NCT00240448|"~     The primary objective of this study is to compare the effectiveness of telmisartan 80~     mg/hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg/hydrochlorothiazide 25 mg~     [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.~   "
252966|NCT00240435|"~     The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10~     mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to~     placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary~     objective was to compare the safety of tiotropium inhalation solution delivered by the~     Respimat to placebo and ipratropium bromide MDI.~   "
252967|NCT00240422|"~     The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan~     or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow~     (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.~   "
252968|NCT00240409|"~     The objective of this study was to investigate the efficacy and safety of Pramipexole Tablets~     in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a~     single blind, comparative method using Bromocriptine tablets as comparators (phase III~     comparative trial)~   "
252969|NCT00240396|"~     The purpose of this prospective randomized study is to evaluate the risks and benefits of~     using bimodal analgesia, (i.e. Narcotics and NSAIDS) vs Narcotics alone post long bone~     fracture.~   "
252970|NCT00240383|"~     A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the~     Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes~   "
252971|NCT00240370|"~     The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic~     control on metformin alone, have a similar, or not inferior, glycemic response when treated~     with the combination of muraglitazar and metformin compared to pioglitazone and metformin.~   "
252972|NCT00240357|"~     The purpose of the study is to determine whether an Internet based compliance tool is~     superior to common diet counselling in patients with hypercholesterolemia.~   "
252976|NCT00240305|"~     The purpose of this study is to investigate the dose-related effect of treatment with~     rosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) and~     apolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-density lipoprotein~     cholesterol (HDL-C) concentration.~   "
252977|NCT00240292|"~     The purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of~     40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular~     ejection fraction on radionuclide ventriculography, at 26 weeks post randomisation from~     baseline.~   "
252978|NCT00240279|"~     To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in~     hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)~   "
252979|NCT00240266|"~     The purpose of this study is to investigate the effect of treatment with rosuvastatin on the~     capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting~     step in reverse cholesterol transport.~   "
252980|NCT00240253|"~     The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an~     established regimen of insulin glargine in subjects with type 2 diabetes who are not~     achieving glycemic targets.~   "
252981|NCT00240227|"~     This double-blind placebo controlled crossover pilot trial will test the hypothesis that~     prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice~     in cocaine-dependent and alcohol-dependent veterans. Both the study medication period and the~     placebo period are each 4 weeks in duration.~   "
252982|NCT00240214|"~     The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under~     everyday conditions~   "
252983|NCT00240188|"~     The purpose of this research is to compare open ventral incisional hernia repair to the~     laparoscopic repair with respect to complications, recurrence, pain, return to normal~     activities of daily living, and return to work.~   "
252984|NCT00240175|"~     Foot orthotics or shoe inserts are currently utilized as a common conservative treatment~     option for a wide variety of foot disorders. This treatment is used for both the relatively~     healthy active population and the more sedentary population with diabetes or peripheral~     vascular disease (dysvascular). However, there is limited objective scientific data~     documenting the actual benefits or effectiveness of either customized or over-the-counter~     foot orthoses. It is the aim of this study to determine the effects of three popular foot~     orthotics on plantar pressures in diabetic populations. If foot orthoses can be utilized as a~     preventive treatment option to reduce the risk for foot ulceration by redistributing plantar~     pressures, then orthoses would be a cost effective solution to a high cost (mental and~     fiscal) medical impairment.~   "
252985|NCT00240162|"~     The purpose of this study it to evaluate the efficacy of PTK787/ZK 222584, in inducing at~     least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein~     levels are < 5 g/dL following high dose chemotherapy (HDCT) and autologous stem cell~     transplantation (ASCT).~   "
252986|NCT00240149|"~     Recent studies of adult intensive care unit (ICU) patients have shown significantly decreased~     morbidity and mortality when blood sugar concentrations are closely controlled. The safety~     and efficacy of this type of blood sugar management has not been studied in the pediatric ICU~     population. Based on the current pediatric literature data as well as our extensive~     retrospective study, blood sugar concentrations have a potentially profound role to play~     among PICU patients. In preparation for a multi-center randomized control trial, we propose a~     prospective feasibility study to evaluate the safety and effectiveness of using an insulin~     delivery algorithm to manage blood sugar in the PICU. Our hypothesis for this feasibility~     trial is that uniformly monitoring and controlling blood glucose with a~     Discrete-Closed-Loop(DCL) insulin delivery algorithm will be an effective, safe, and~     consistent means of delivering insulin to manage glucose in the pediatric intensive care~     unit.~   "
252987|NCT00240136|"~     The purpose of this research is to observe the effects of RA over a long period in order to~     learn which of the early characteristics of patients' early RA predict future joint damage~     and disability. We also investigate whether certain treatments can prevent or slow the~     development of joint damage and disability. Additionally, the costs and effects of RA on the~     patient are studied in order to improve the methods used to measure these effects. Clinical,~     demographic, radiographic, and laboratory measures are taken by the rheumatologist in the~     office. In addition, patient questionnaires are mailed & completed by the patient and~     returned to the coordinating center at UCLA. All information obtained by these means will be~     studied in their effects on early, severe RA.~   "
252988|NCT00240123|"~     The purpose of the study is to determine if adding Benadryl improves sedation for patients~     scheduled to undergo ERCP or EUS procedures.~   "
252989|NCT00240110|"~     This proposal will test the efficacy of a promising pharmacological approach for the~     treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized,~     double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium~     (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing~     cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and~     bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood~     stabilization plus supportive psychosocial treatment.~   "
252990|NCT00240097|"~     The primary objective of Part I of the study is to determine tumor response rate of~     sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide~     /carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer. The~     primary objective of Part II of the study is to determine the objective tumor response rate~     of irinotecan/oxaliplatin in patients with either refractory disease or who have relapsed to~     first line chemotherapy or chemoradiotherapy.~   "
253006|NCT00239876|"~     This study will evaluate the safety and efficacy of FTY720 combined with tacrolimus and~     corticosteroids in patients receiving a kidney transplant~   "
253007|NCT00239863|"~     This study will evaluate the safety and efficacy of FTY720 versus mycophenolate mofetil (MMF,~     Roche brand) combined with cyclosporine and corticosteroids in patients receiving a kidney~     transplant.~   "
253008|NCT00239850|"~     The purpose of this study is to evaluate the effects of conservative treatments of obesity~     with surgery (gastric bypass).~   "
253009|NCT00239837|"~     This study will determine the efficacy of a parent-involved intervention in preventing~     problem behavior in middle school girls who are currently in foster care.~   "
252991|NCT00240084|"~     This research study, funded by Scios, Inc., and conducted by the Cardiology Division of the~     Department of Medicine at the University of Rochester School of Medicine and Dentistry~     investigates the potential benefit of nesiritide (brand name is Natrecor(TM))in improving~     exercise capacity in patients with heart failure (HF). Previous studies have shown beneficial~     hemodynamic and neurohumoral effects of nesiritide infusion in the therapy of decompensated~     heart failure. Other studies have demonstrated increases in endogenous BNP levels (normalized~     for exercise workload) in HF patients during and after exercise. However, trials involving~     the measurement of exercise capacity in this population following BNP administration are~     lacking. This is an experimental prospective, non-blinded, pilot study with a sample size of~     20 patients, all serving as their own controls. This study involves off-label use of the drug~     nesiritide (indicated for IV treatment of NYHA Class II and III patients, and this study is~     enrolling Class II and III patients) and has received FDA approval, and an IND. Subjects are~     recruited from the population of referrals to the Strong Memorial Hospital Heart Failure and~     Transplantation clinical service, who meet all the inclusion criteria and none of the~     exclusion criteria may participate in the study. Enrolled study subjects perform an exercise~     VO2 max test, receive a 24 hour infusion of nesiritide and perform a second exercise VO2 max~     test.~   "
252992|NCT00240071|"~     The purpose of this study is to determine if acquired hormone therapy resistance can be~     reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate~     toxicity of the combination of hormone treatment plus Avastin (Bevacizumab).~   "
252993|NCT00240058|"~     This is a research project to test two study techniques among healthy adults. The procedures~     look at how blood flow is controlled by substances in blood vessels.~   "
252994|NCT00240045|"~     We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are~     mediated in part by diminished circulatory volume and that treatment with midodrine,~     octreotide and albumin can improve renal and patient outcomes by restoring effective~     circulating volume and systemic perfusion.~      Our primary objective is to assess change in creatinine clearance using inulin. We will~     enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and~     exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR,~     albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before,~     during, and after initiation of drug and compared.~   "
252995|NCT00240032|"~     This study is designed to compare injection skin (injection site) reactions when an~     antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections.~     Patients will be assigned (like a flip of a coin) to take either a placebo or an~     antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and~     physician will be unaware whether they are taking a placebo or antihistamine during the~     study.~   "
252996|NCT00240019|"~     The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with~     diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent~     (furosemide) will decrease the urine protein, which is a sign of disease, more than an~     angiotensin converting enzyme inhibitor alone.~   "
252997|NCT00240006|"~     To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample~     of MS patients who are at high risk of nonadherence and receive support from Shared~     Solutions® and their MS Center versus those who receive support only from Shared Solutions®.~   "
252998|NCT00239993|"~     This study is designed to compare skin reactions with or without the use of warm compress~     prior to performing a Copaxone® injection.~   "
252999|NCT00239980|"~     Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term~     survival is poor for the majority of women with EOC because many present with advanced~     disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but~     relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in~     survival and is associated with unacceptable toxicity. This phase II, dose-finding, open~     label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3~     doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based~     chemotherapy. The primary outcome is disease response, measured according to Gynaecologic~     Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes~     include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin~     associated with the best response will be tested further in a phase III randomized clinical~     trial in the same patient population.~   "
253000|NCT00239967|"~     The purpose of this study is to assess the effect of rimonabant 20 mg on HDL (high density~     lipoprotein) cholesterol and on TG (triglycerides) plasma levels over a period of one year~     when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese~     patients with atherogenic dyslipidemia (low HDL and/or high TG plasma levels). The secondary~     objectives are to evaluate specific metabolic parameters, visceral fat (in selected sites),~     safety and tolerability of rimonabant 20 mg.~   "
253001|NCT00239954|"~     The purpose of this study is to evaluate the effectiveness, safety and tolerability of an~     escitalopram combination treatment compared to single treatments, and to placebo in patients~     with major depressive disorder.~   "
253002|NCT00239928|"~     This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients~     with wet-type age-related macular degeneration (AMD), who benefit further treatment and who~     want to continue the treatment after completion of the preceding study (A5751010).~   "
253003|NCT00239915|"~     This is a research study of the investigational drug, Pagoclone, in the treatment of~     persistent developmental stuttering (PDS), which includes frequent repetitions or~     prolongations of sounds or syllables or words, or frequent hesitations or pauses that disrupt~     the flow of speech. Pagoclone is an investigational drug, so it is not approved by the United~     States Food and Drug Administration.~   "
253004|NCT00239902|"~     This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and~     corticosteroids in patients receiving a kidney transplant.~   "
253005|NCT00239889|"~     Calcitonin has been used for many years for treating osteoporosis in postmenopausal women,~     and it has been shown that calcitonin reduces pain after spine and hip fracture in women with~     osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin~     nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture~     healing in postmenopausal women.~   "
253016|NCT00239746|"~     The purpose of this study is to test the effect of ibuprofen on the levels of a number of~     different proteins (called biomarkers) in cerebrospinal fluid (CSF), blood, and urine to see~     whether ibuprofen can influence certain biomarkers associated with the progression of~     Alzheimer's Disease.~   "
253017|NCT00239733|"~     Thrombocytopenia occurs when a person's blood has a decreased number of platelets, which are~     cells involved in blood clotting. This condition may lead to uncontrolled bleeding and can be~     fatal. Thrombocytopenia commonly occurs with hepatitis C virus (HCV) infection or as a result~     of standard HCV treatment. Anti-D is an antibody approved by the Food and Drug Administration~     (FDA) for the treatment of HIV-related thrombocytopenia. The purpose of this study is to~     determine the safety and effectiveness of intravenous anti-D for the treatment of~     thrombocytopenia in patients with HCV infection who are starting or already undergoing~     treatment with peginterferon alfa-2 and ribavirin. This study will recruit HCV patients both~     with and without HIV co-infection.~   "
253018|NCT00239720|"~     hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ~     rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe~     and effective in psoriatic arthritis patients who are unable to control their arthritis with~     methotrexate or azathioprine.~   "
253019|NCT00239707|"~     The purpose of this study is to test the safety of glucose-dependent insulinotropic peptide~     (GIP)/GIP Analog on people with Type 2 Diabetes.~   "
253020|NCT00239694|"~     The purpose of this study is to measure how long the improvement in the immune system lasts~     in older people after they have been vaccinated, and to examine the immune response in older~     people who get vaccinated a second time.~   "
253021|NCT00239681|"~     The purpose of this study is to determine the safety and effectiveness of long-term therapy~     with rosuvastatin compared with a placebo, and to evaluate whether treatment with~     rosuvastatin might be effective in reducing the risk of major cardiovascular events.~   "
253022|NCT00239668|"~     The purpose of this study is to establish an expected recovery trajectory (recovery model) in~     terms of physical and psychological function of the pediatric burn patient.~   "
253023|NCT00239655|"~     The purpose of this study is to test MK0812 on disease activity in patients with~     relapsing-remitting MS. Disease modifying activity will be assessed by measurement of brain~     lesions via MRI brain scans and an open label extension is offered.~   "
253024|NCT00239642|"~     Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney~     disease (CKD) patients~   "
253025|NCT00239629|"~     The aim of this study is to directly compare the bone forming effects of 20 microg/day of~     teriparatide with those of 2 g/day strontium ranelate as measured by the histomorphometric~     variables and biochemical bone formation markers after 6 months of therapy in postmenopausal~     women with osteoporosis.~   "
253026|NCT00239616|"~     This is an open-label, multicenter pharmacokinetic study of HD od PD patients receiving~     erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push~     over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7~     days for safety endpoints.~   "
253027|NCT00239603|"~     The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict~     ovulation while women are taking clomiphene citrate.~   "
253028|NCT00239590|"~     Testosterone has traditionally been regarded as a risk factor for heart disease due to the~     fact that males have a higher incidence of this disease than women, at least until the~     menopause. However recent studies have shown that men with low levels of testosterone may be~     at an increased risk of developing coronary heart disease (furring up of the blood vessels~     supplying blood to the heart). Our group has demonstrated a relaxing effect of testosterone~     in isolated animal coronary arteries (blood vessels supplying blood to the heart). We have~     shown that short-term testosterone administration can increase coronary artery and brachial~     artery (blood vessel in the arm) blood flow and can decrease the lack of blood supply to the~     heart muscle in men with coronary artery disease. These findings indicate a need for similar~     but longer-term studies to investigate the possible beneficial effects of longer-term~     testosterone therapy on the heart and blood vessels. Should this treatment be shown to be~     beneficial to men with coronary artery disease it may be a useful additional therapy for men~     with the furring up of arteries in the heart and the resulting angina.~      Aim To investigate our hypothesis that testosterone can beneficially affect myocardial~     perfusion, vascular reactivity, metabolic risk factors for coronary heart disease and improve~     quality of life in men with low plasma testosterone levels and coronary heart disease.~   "
253029|NCT00239577|"~     This descriptive study will evaluate the safety and immunogenicity of 5 different~     formulations of the WRAIR dengue vaccine compared to a placebo.~   "
253030|NCT00239564|"~     The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and~     carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease~     who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release~     tablets.~   "
253031|NCT00239551|"~     The purpose of this study is to measure the prostaglandin levels in patients with stress~     ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.~   "
253032|NCT00239538|"~     The primary objective of this study is to demonstrate that telmisartan 80 mg combined with~     hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to~     valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean~     ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6~     hours of the 24-hour dosing interval at the end of a 10-week treatment period in~     mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus~   "
253033|NCT00239525|"~     The purpose of this study is to investigate real time 3-D ultrasound imaging of the brain for~     the diagnosis and evaluation of stroke.~   "
253051|NCT00239291|"~     To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in~     patients with non-metastatic prostate cancer~   "
253052|NCT00239278|"~     The purpose of this study is to determine whether the budesonide+formoterol combination is~     effective in the treatment of exacerbations of COPD with a main emphasis on investigating the~     effects on inflammation and a secondary emphasis on clinical efficacy~   "
253053|NCT00239265|"~     The purpose of this study is to determine whether Tamuslosin is effective in the treatment of~     lower urinary tract syndrome with female patients.~   "
253034|NCT00239512|"~     Patent ductus arteriosus (PDA) is one of the most common complications in premature infants.~     Successful pharmacological closure of PDA with indomethacin was first reported in 1976. Since~     then indomethacin treatment has become the standard or prophylactic treatment for clinically~     significant PDA in premature infants. Clinically there is a high incidence of complications~     associated with indomethacin treatment, including hypoglycemia, necrotizing enterocolitis, GI~     bleeding, extension of IVH. More recently, ibuprofen has been shown to be effective for the~     closure of patent ductus arteriosus in premature infants without reducing mesenteric, renal,~     or cerebral blood flow.Ibuprofen has been shown to close the ductus in animals without~     reducing cerebral,intestinal or renal blood flow. Furthermore, ibuprofen enhanced cerebral~     blood-flow autoregulation and had some neuroprotective effect. In recent years, our strategy~     of PDA treatment for ELBW infants was essentially early targeted indomethacine treatment~     depending on echocardiographic shunt flow pattern of PDA. (Arch Dis Child 1997;77:F36-F40.~     Acta Paediatr Tw 1998;39:33-7. and Arch Dis Child 1999;79: F197-F200.) By this regimen,~     infants will be eligible for the study if their birth weight less than 1000 gm and if they~     had PDA without other structured cardiac anomaly confirmed by echocardiography shortly after~     birth (as close as possible to12 hours). After parental informed consent is obtained, infants~     will be randomly assigned to two groups based on a double-blined design. INDO group will~     receive echocardiographic assessment at interval of 12-24 hours or clinically necessary, and~     if the PDA had pulsatile or growing flow pattern, indomethacin is given; if the PDA had flow~     patterns other than growing or pulsatile pattern, no treatment is given. The subsequent dose~     of indomethacin is according to the echocardiographic flow patterns at interval of 24 hours~     from the last dose. When indomethacin was fail to close after the first course, the second~     course of another 3 doses of indomethacin or ibuprofen will be given. In spite of infants of~     INDO group or IBUO group, if PDA fail to close after 2 courses of treatment, surgical~     ligation of PDA would be considered according to the infant’s clinical condition. Our~     historical data showed that the incidence of complication was about 30%. Permitting 5% chance~     of type I error and 20% of type II error and an absolute reduction of the incidence by 20%,~     30 infants in each group is needed to detect a difference. Primary outcome of the assessment~     is the closure rate of PDA and the incidence of death or pulmonary hemorrhage. Secondary~     outcome is IVH or PVL, NEC, oliguria and CLD. We expect that, by using this treatment~     regimen, a high PDA closure rate can be achieved and the survival of very premature infants~     may be increased.~   "
253035|NCT00239499|"~     The primary objective of this study is to estimate the comparative bronchodilator effect size~     and variability for tiotropium (Spiriva, 18 µg q.d.) with the free combination of salmeterol~     (Serevent, 50 µg b.i.d.) and fluticasone (Flixotide, 250 µg b.i.d.) in COPD patients.~      International COPD guidelines preserve milder stages of the disease (GOLD stage I and IIa) to~     bronchodilators and recommend the addition of inhaled corticosteroids only in those patients~     who have a documented spirometric response to inhaled corticosteroids and in patients with a~     post-bronchodilator FEV1 of less than 50% predicted, who suffer from frequent exacerbations~     requiring oral courses of corticosteroids.~      Recently published reports indicate that additional bronchodilator efficacy may be achieved~     when a long-acting beta agonist is combined with an inhaled corticosteroid. Steady state~     bronchodilation was achieved within one week with the drug combination. However, results of~     these studies are not consistent, and since the inclusion criteria employed were different~     from those utilised in the previously conducted tiotropium studies, it is difficult to~     generalise the observed effects to the general COPD population.~      In addition, no comparative data is available on the average response over the 12 daytime~     hours when COPD patients are active and in most need of bronchodilation. 12 hours corresponds~     to the dosing intervals for both salmeterol and fluticasone.~   "
253036|NCT00239486|"~     The purpose of this study was to evaluate the efficacy and safety of different doses of~     pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs~     Syndrome (RLS) and also to determine the optimal dose of pramipexole in patients with RLS by~     polysomnography and evaluation of clinical improvement.~   "
253037|NCT00239473|"~     The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10~     mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to~     placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary~     objective was to compare the safety of tiotropium inhalation solution delivered by the~     Respimat to placebo and ipratropium bromide MDI.~   "
253038|NCT00239460|"~     The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough~     FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients~     with COPD.~   "
253039|NCT00239447|"~     Non-inferiority of lung function response to Tiotropium inhalation solution compared to~     Spiriva HandiHaler~   "
253040|NCT00239434|"~     The objective of this study is to compare the bronchodilator efficacy and safety of once~     daily dosing of tiotropium inhalation capsules (18 ?g) and Atrovent? MDI (2 puffs of~     ipratropium bromide 20 ?g four times daily) in patients with chronic obstructive pulmonary~     disease.~   "
253041|NCT00239421|"~     To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol~     plus fluticasone in COPD patients.~   "
253042|NCT00239408|"~     Evaluate whether the effect of inhaled tiotropium bromide on the change in trough forced~     expiratory volume (FEV1), compared to placebo in patients with chronic obstructive pulmonary~     disease (COPD), is affected by smoking status.~   "
253043|NCT00239395|"~     The objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m.~     once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with~     osteoarthritis over a time period of 7 days.~   "
253044|NCT00239382|"~     The objective of this trial was to assess the efficacy and safety of 15 mg meloxicam i.m.~     once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with Rheumatoid~     arthritis over a time period of 7 days.~   "
253045|NCT00239369|"~     The primary objective of this trial is to demonstrate that a fixed dose combination of~     telmisartan 80 mg plus hydrochlorothiazide 25 mg (T80/H25) is superior in reducing blood~     pressure after eight weeks compared with a fixed dose combination of telmisartan 80 mg plus~     hydrochlorothiazide 12.5 mg (T80/H12.5) in patients who fail to respond to six weeks~     treatment with T80/H12.5.~   "
253046|NCT00239356|"~     The purpose of this study is to provide aripiprazole to schizophrenic outpatients and~     Community Treated Patients who are currently receiving aripiprazole therapy on another BMS~     sponsored clinical trial.~   "
253047|NCT00239343|"~     The aim of the study is to estimate the effect of preoperative gefitinib on the complete~     pathological response rate in primary estrogen receptor negative breast cancer at the time of~     surgery.~   "
253048|NCT00239330|"~     The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with~     atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target~     goals after 12 weeks of therapy.~   "
253049|NCT00239317|"~     The purpose of this study is to determine whether Tamusulosin is effective in the treatment~     of lower urinary tract syndrome with male patients.~   "
253050|NCT00239304|"~     To determine the safety and tolerability of gefitinib in combination with cisplatin and~     radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.~   "
253055|NCT00239239|"~     The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of~     darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly~     (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.~   "
253056|NCT00239226|"~     This study is a long-term, prospective, and controlled evaluation of the incidence of~     persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction~     delay paced with preventive algorithms at the interatrial septum (IAS) versus right atrial~     appendage (RAA).~   "
253057|NCT00239213|"~     The purpose of this study is to clarify the preventive effects of catechin gargling on the~     influenza infection.~   "
253058|NCT00239200|"~     The purpose of this study is the determine whether a new compound, called lapatinib, can be~     effective in shrinking cancerous tumors of the esophagus that have recurred or spread~     somewhere else in the body. They also want to determine the toxicity of this regimen.~     Lapatinib blocks 2 receptors that sometimes are present on cancer cells (called epidermal~     growth factor receptor, and the Erb B2 receptor). It is possible that blocking these~     receptors may decrease the growth of the cancer cells.~   "
253059|NCT00239187|"~     The purpose of the study is to determine whether E1 and G1 are safe and effective in the~     treatment of type 2 diabetes.~      Type 2 diabetes is the most common form of diabetes. The disease is characterised by insulin~     resistance and a compensated state of hyperinsulinemia. In most individual, hyperglycemia~     results from a failure of pancreatic beta cells insulin secretory capacity to adequately~     compensate for insulin resistance in peripheral tissues. Treatment for type 2 diabetes is~     achieved by dietary control, or a combination of diet and oral hypoglycemic agents or~     insulin. As the disease progress, many type 2 diabetic patients eventually require insulin as~     primary therapy to achieve glycemic control.~      Recent diabetic research has increasingly focused on pancreatic islet cell replacement,~     either by islet cell transplantation or by endogenous regeneration of islet cells. During~     fetal development, islet precursor cells proliferate and differentiate into mature beta cells~     capable of producing insulin. This process is known as islet cell neogenesis. Islet cell~     neogenesis normally ceases around birth, however, the adult pancreas still retains~     significant potential for islet regeneration, as shown by tissue repair following pancreatic~     injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis~     and increase insulin production in diabetic animal models. In type 2 diabetic patients,~     treatment with E1 and G1 may result in islet cell regeneration. This therapeutic approach may~     improve beta cell function, restore the loss of insulin secretory capacity and also benefit~     patients on oral hypoglycemic agents by delaying insulin use.~   "
253060|NCT00239174|"~     The purpose of this study is to assess the effect of SR147778 on weight loss over a period of~     24 weeks when prescribed with a hypocaloric diet in obese patients. The secondary objective~     is to assess the safety and tolerability of SR147778 and to assess the effect of SR147778 on~     several secondary parameters (such as waist, metabolic parameters) over a period of 24 weeks~     when prescribed with a hypocaloric diet in obese patients.~   "
253061|NCT00239161|"~     The purpose of the study is to compare the safety and effectiveness of the antibiotic~     levofloxacin by administering a higher dose of levofloxacin using a shorter course of therapy~     to treat patients with infections of their kidney.~   "
253062|NCT00239148|"~     The purpose of the study is to determine whether E1 and G1 are safe and effective in the~     treatment of type 1 diabetes.~      Type 1 diabetes is an autoimmune disease, in which the immune system attacks pancreatic beta~     cells. These cells produce insulin, which regulates blood glucose. The mainstay of current~     treatment for type 1 diabetes is dietary control and daily parenteral administration of~     insulin.~      Recent diabetes research has increasingly focused on pancreatic islet cell replacement,~     either by islet cell transplantation or by endogenous regeneration of islet cells. During~     fetal development, islet precursor cells proliferate and differentiate into mature beta cells~     capable of producing insulin. This process is known as islet cell neogenesis. Islet cell~     neogenesis normally ceases around birth, however, the adult pancreas still retains~     significant potential for islet regeneration, as shown by tissue repair following pancreatic~     injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis~     and increase pancreatic insulin production in diabetic animal models. It is therefore~     postulated that treatment with E1 and G1 may produce islet cell regeneration in type 1~     diabetic patients.~   "
253063|NCT00239135|"~     The purpose of this study is :~        -  To determine the maximum tolerated dose (MTD) for PEP005 Topical Gel in patients with~          actinic keratoses.~        -  To evaluate patients for clinical safety~        -  To determine the systemic absorption of PEP005 Topical Gel~   "
253064|NCT00239122|"~     This project will systematically apply a specialist version of Cognitive Behaviour Therapy~     (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders.~     Previously, the therapy has been developed and efficacy established, but the extent of~     applicability to (unselected) mental health service patients is unknown. The main aim is to~     establish the extent to which this therapy is acceptable and effective for mental health~     service clients. A secondary aim is to develop guidelines for the conduct of such therapy in~     public mental health settings.~   "
253082|NCT00238888|"~     The objectives of this trials are to demonstrate, in children with poorly controlled asthma,~     that an intervention to increase the awareness and the impact of poor asthma control among~     parents and physicians of affected children and adolescents can reduce the rate of asthma~     emergency visits in the 12 months following the initiation of the intervention.~   "
253083|NCT00238875|"~     To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer~   "
253084|NCT00238862|"~     Patients with persistent corneal epithelial defects who have not responded to conventional~     therapy will be randomized to treatment with either amniotic membrane transplantation or~     autologous serum 20%. Outcome measures will be (1) presence or absence of complete~     re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90~     days.~   "
253085|NCT00238849|"~     The purpose of this study is to determine the response rate to treatment with oxaliplatin and~     Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been~     clinically evaluated yet. However, Navelbine has been safely administered with other platinum~     compounds.~   "
253065|NCT00239109|"~     -  Various studies suggest that patients treated with Olanzapine can experience a~          substantial weight gain, while no changes have been observed in patients treated with~          Ziprasidone. Negative consequences on lipid and glucose profiles have also been observed~          in patients treated with Olanzapine. Most of the available data belong to short-term~          studies. However, for most clinical trials the primary variable was an efficacy~          variable, and included the weight assessment as a secondary variable; they also lack a~          systematic monitoring of some variables that can play a role in weight gain, as the~          level of exercise, appetite increase, etc. and we have considered of importance their~          inclusion in this protocol. Previous studies did not assess visceral fat using widely~          standardized parameters as the waist index, which at certain levels is considered an~          indicator of the cardiovascular risk, or leptine, highly correlated to the body fat~          storage. We would like to fit the recently published American Diabetes Association,~          American Psychiatric Association, American Association of Clinical Endocrinologists and~          North American Association for the Study of Obesity Antipsychotic, obesity and diabetes~          mellitus consensus.22~        -  Schizophrenic patients show a 4-fold probability to die as a consequence of~          cardiovascular problems compared to the normal population. The antipsychotic treatment~          can contribute to increase this risk favoring weight gain and the appearance of~          cardiovascular risk factors associated to obesity (blood hypertension, hyperlipidemia,~          type II Diabetes Mellitus). We intend to obtain a complete cardiovascular risk profile~          of patients, as well as its change during antipsychotic treatment, including primary~          cardiovascular risk factors in addition to the analysis of markers that have recently~          been linked to cardiovascular risk (as reactive protein C).~        -  The study will evaluate the risk of hyperglycemia, insulin resistance and Diabetes~          Mellitus, and will investigate the association between glucose homeostasis abnormalities~          and weight gain in the treated patients. Likewise, adiponectine, secreted from~          adipocytes and a possible link between obesity and insulin resistance will be~          determined; recent studies show an adiponectine decrease in humans with insulin~          resistance and obesity; furthermore, prospective studies have shown these changes could~          predict a higher risk of DM development.~        -  Changes have been introduced in the complete evaluation of the patient's metabolic and~          cardiovascular profiles with the advice, and under the coordination of endocrinologists~          after a complete review of the subject~   "
253066|NCT00239096|"~     The purpose of this study is to determine whether losartan, an angiotensin II blocker~     prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid~     retention. Moreover is the purpose to asses whether losartan is antifibrotic.~   "
253067|NCT00239083|"~     The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in~     combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.~   "
253068|NCT00239070|"~     This extension study is to assess the long-term safety of EC-MPS~   "
253069|NCT00239057|"~     The aim of this study is to evaluate if the addition of EC-MPS to CsA-ME allows the safe~     withdrawal of the concomitant corticosteroid therapy in long-term maintenance renal allograft~     recipients.~      All patients of the core study who are interested of being treated with EC-MPS will be~     included in an open-label extension study to collect further information on the long-term~     safety, tolerability and efficacy of this drug.~   "
253070|NCT00239044|"~     To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can~     be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months~     after switching from MMF to a EC-MPS regimen.~   "
253071|NCT00239031|"~     All patients of the core study who are interested of being treated with EC-MPS will be~     included in an open-label extension study to collect further information on the long-term~     safety, tolerability and efficacy of this drug.~      The aim of this study is to compare the renal function, 6 months after transplant, in de novo~     old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with~     EC-MPS plus standard dose CsA-ME, both in combination with basiliximab and short-term oral~     steroids.~   "
253072|NCT00239018|"~     The objective of this extension study is to allow patients being treated with enteric-coated~     mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to~     assess the long-term safety of EC-MPS~   "
253073|NCT00239005|"~     This open, multi-center randomized controlled study is designed to investigate the quality of~     life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse~     events after converting to enteric-coated mycophenolate sodium (EC-MPS).~   "
253074|NCT00238992|"~     All patients of the core study who are interested of being treated with EC-MPS will be~     included in an open-label extension study to collect further information on the long-term~     safety, tolerability and efficacy of this drug.~      The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting~     of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo~     kidney allograft recipients.~   "
253075|NCT00238979|"~     The aim of this study is whether a switch of stable renal transplant recipients who receive~     tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated~     mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.~   "
253076|NCT00238966|"~     This extension study is considered to allow patients being treated with EC-MPS to collect~     further information on the long-term safety of this drug.~   "
253077|NCT00238953|"~     Clinical trial for the novo transplant recipients, which aims to assess tolerability and~     safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion~     (CsA-ME) with or without steroids in a population of kidney transplant recipients.~   "
253078|NCT00238940|"~     This extension study is considered to allow patients being treated with EC-MPS to collect~     further information on the long-term safety of this drug.~   "
253079|NCT00238927|"~     The purpose of this study is to determine, in children aged 1 to 6 years with recurrent~     asthma induced by upper respiratory tract infections (URTI), whether the administration of~     high doses of inhaled fluticasone started at the onset of symptoms of a cold will result in a~     reduced severity and shorter duration of asthma exacerbations and will not be associated with~     reduced growth velocity, osteopenia, and adrenal suppression.~   "
253080|NCT00238914|"~     The overall goal of this research project is to test a newly developed behavioral therapy to~     enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone~     maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES:~        1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of~          relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE)~          Therapy.~        2. Lifetime history of depression will predict dysphoria and non-compliance with~          naltrexone.~   "
253081|NCT00238901|"~     The natural history of HCV infection in liver transplant recipients may be accelerated when~     compared to that in patients with normal immune systems.~      The objective of this trial is to assess the efficacy and safety of basiliximab, in~     combination with cyclosporin and MMF on the success rate of liver transplants for HCV related~     cirrhosis, in comparison with standard steroid treatment.~   "
253105|NCT00238563|"~     Determine efficacy of sub tenon kenalog injections for post-operative management of~     trabeculectomy procedures.~   "
253086|NCT00238836|"~     The University of Ottawa and Élisabeth Bruyère Research Institute are conducting a study of~     preventive care for frail patients at risk of functional decline. At risk patients are~     assigned by chance to continue receiving their standard care from their family physician or~     receive additional care from a nurse practitioners and a pharmacist. In collaboration with~     the family physician, they develop an individualized care plan, a treatment and management~     road plan, for each patient, which they implement over the study period of one approximately~     year. The objective of the study is to compare the effectiveness of the model of care that~     includes the nurse practitioners and pharmacist against standard care in preventing~     functional decline, to determine the acceptability of this model of care to patients, their~     caregivers and the medical team, and to evaluate the cost implication of the program.~   "
253087|NCT00238823|"~     The purpose of this retrospective study is to describe why and when we used cryo and why we~     crossed over when we used both RFA and cryo. It is also to determine if there is some~     predictor that would make us say one patient would be better served with one technique than~     another and to describe our overall acute success rate and then our 6-month recurrence rate~     with cryo ablation and compare it to our known success rate with RFA.~   "
253088|NCT00238810|"~     The purpose of this study is to assess brain natriuretic peptide levels to evaluate the~     relationship of those levels with the diagnosis of congenital cardiac disease, operation~     performed, post-operative course, and outcome.~   "
253089|NCT00238797|"~     The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination~     with radiotherapy on patients with glioblastoma multiforme.~   "
253090|NCT00238784|"~     The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best~     Conventional Practice in patients with persistent asthma~   "
253091|NCT00238758|"~     The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are~     effective as a monotherapy for depression.~   "
253092|NCT00238745|"~     Dose-response in Japanese patients with postmenopausal osteoporosis.~   "
253093|NCT00238732|"~     The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are~     effective in the treatment of vaginal atrophy.~   "
253094|NCT00238719|"~     To determine the anxiolytic efficacy, safety, and tolerability of a flexible-dose of~     venlafaxine extended release (ER) administered for 16 weeks in the treatment of children and~     adolescent outpatients with social anxiety disorder (generalized) in a placebo-controlled~     study.~   "
253095|NCT00238706|"~     The aim of this prospective randomized clinical trial was to evaluate the early and late~     outcome following left atrial radiofrequency ablation during MV surgery for the treatment of~     continuous atrial fibrillation and to assess the functional effects of restoration of sinus~     rhythm.~   "
253096|NCT00238693|"~     This is a registry of data collected from patient records, both of those who have a condition~     which may require transplantation and those who have undergone transplantation of the liver,~     kidney and/or pancreas.~   "
253097|NCT00238680|"~     The purpose of this study is to evaluate the effect of bladder rehabilitation in a~     non-selected group of children with idiopathic overactive bladder and to clarify whether the~     effect of the treatment can be increased by addition of a programmable timer~   "
253098|NCT00238667|"~     This is a feasibility study to determine if a sufficient number of patients can be recruited~     throughout the United Kingdom and whether sufficient endpoints can be generated for a full~     scale therapeutic trial of anticoagulants versus antiplatelets in acute cervical artery~     dissection treatment.~   "
253099|NCT00238654|"~     This study has patients responding to two sets of surveys that will tell their doctor or~     nurse about their readiness to begin self-injection. In addition, patients will have their~     self-injection observed and evaluated on up to three visits~   "
253100|NCT00238641|"~     In children with cerebral palsy, stiffness of the arm can develop early and delay or prevent~     the acquisition of normal hand skills. Improvement in functional use of the hand may~     therefore be dependent upon early treatment of upper extremity hypertonia. We propose to test~     a series of injections of Myobloc™ in a non-randomized one-way crossover pilot clinical trial~     and dose-finding study, with clinical assessments and blinded video evaluations. Ten children~     age 2-17 years with increased tone at the elbow or wrist will be expected to complete the~     study. A 1-month baseline evaluation period will be followed by an injection of low-dose~     Myobloc™ to affected muscle(s) of the arm according to standardized per-kilogram dosing with~     a maximum of 25U/kg in each affected arm. Three months later, a second injection of up to~     50U/kg will be performed in each affected arm. Three months after the second dose, a third~     dose of up to 100U/kg will be performed in each affected arm. Neurological assessments will~     be performed at study entry, prior to each injection, and at 1 and 3 months following each~     injection. Routine physical therapy and non-study medications will be continued during the~     study.~   "
253101|NCT00238628|"~     The purpose of Phase 1 of this study is to evaluate the safety of the combination regimen,~     bexarotene and ZD1839. Phase II will evaluate the median survival, time to disease~     progression, and toxicity.~   "
253102|NCT00238615|"~     The purpose of this study is to assess how well this particular combination of chemotherapy,~     radiation and surgery works to help people with locally advanced lung cancer, how well PET~     scans indicates whether someone has responded to chemotherapy and radiation, and gene~     expression patterns related to outcomes in patients with locally advanced lung cancer who~     receive this treatment regimen.~   "
253103|NCT00238602|"~     This study has two primary objectives. The first objective is to determine the maximal~     tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with~     inoperable malignant lung tumors. Once the MTD is established, the second objective is to~     determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and~     radiographic responses.~   "
253104|NCT00238576|"~     This project will expand current knowledge of reproductive biology in women with bipolar~     disorder as well as assessing the impact of lamotrigine use for the treatment of bipolar~     disorder on reproductive function. Specifically, this study examines mood over the menstrual~     cycle and ovulation for three consecutive menstrual cycles in women treated for bipolar I,~     II, or NOS (not otherwise specified) with lamotrigine. In addition, testosterone and lipid~     concentrations will be measured before the participant starts receiving lamotrigine, as well~     as six months after receiving lamotrigine.~   "
253106|NCT00238550|"~     The study is designed to investigate the benefit of adding CBME to the existing treatment~     regime in the management of painful neuropathy.~      Hypothesis:~        1. The addition of CBME to the existing treatment regime will result in a significant~          improvement in both primary and secondary outcome measures.~        2. The side effect profile and tolerability of CBME will be minimal and comparable to~          placebo.~   "
253107|NCT00238537|"~     To determine whether the extent of the ischemic penumbra apparent on perfusion-diffusion MRI~     can be used to identify patients who would respond positively and safely to tissue~     plasminogen activator (tPA) beyond 3 hours post-stroke.~   "
253108|NCT00238524|"~     This trial was conducted at about 50 sites in Europe and has been clinically completed.~     Patients had symptoms of painful diabetic neuropathy for 6 months up to 5 years with an~     optimized diabetic control and at least moderate pain. Patients were not eligible with other~     chronic pain or any other medical or psychiatric condition, that would have jeopardized or~     compromised the patient's ability to participate in the trial. After a 2-week run-in phase~     patients were randomly assigned to one of three treatment arms. All patients who had~     completed the 6-week titration phase to reach their target dose entered a 12-week maintenance~     phase. At the end of the maintenance phase, subjects were offered the option of entering the~     open-label, follow-on trial. The change in pain was measured daily as well as interference of~     pain with sleep and general activity.~   "
253109|NCT00238511|"~     This trial was the follow-on trial to a preceeding double-blind, placebo controlled trial~     which included patients with at least moderate pain due to postherpetic neuralgia. It was~     conducted at six sites in Germany and has been clinically finalized. The patients had~     successfully completed the above mentioned trial in postherpetic neuralgia and, in the~     investigator's opinion, would benefit from long-term administration of Lacosamide. After a~     1-week run-in phase the patients were uptitrated to their optimal dose and then continued~     into the maintenance phase. Dose adjustments were allowed throughout the trial.The change in~     pain was measured daily as well as interference of pain with sleep and general activity. As~     per protocol this trial was terminated after two years of treatment.~   "
253110|NCT00238498|"~     This study was not conducted in the United States. The purpose of this study was to assess~     the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the~     treatment of people with type 2 diabetes.~   "
253111|NCT00238485|"~     This extension study is designed to investigate the long-term safety and tolerability of~     licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind~     study CLIC477D2302.~   "
253112|NCT00238472|"~     This study is not being conducted in the United States. The purpose of the study is to~     evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and~     albumin excretion.~   "
253113|NCT00238459|"~     The purpose of this study is to determine the role of HIV-specific CD4 T cell responses and~     immune responses dependent upon these CD4 responses that develop when antiretroviral drugs~     are started during acute or recent HIV infection, whether these CD4 responses can be enhanced~     with a therapeutic HIV vaccine (HIV-1 immunogen), and what pattern of HIV-specific immune~     responses is associated with control of HIV upon discontinuation of antiretroviral drugs~     during an analytical therapeutic interruption. Participants will be treatment-naive adults~     with acute or early HIV infection who will choose to start or not start anti-HIV drugs at the~     beginning of the study. NOTE: In August 2007 we were notified by the manufacturer of the~     candidate vaccine that they were no longer making the vaccine, and that the vaccine would no~     longer be available. Unfortunately too few participants have received either the vaccine or~     placebo to conclude anything about efficacy. No safety problems occurred.~   "
253114|NCT00238446|"~     This purpose of this extension study of patients being treated with EC-MPS is to assess the~     long term safety of this medication.~   "
253115|NCT00238433|"~     RATIONALE: Chemotherapy, such as busulfan, melphalan, and thiotepa, may destroy cancerous~     blood-forming cells (stem cells) in the blood and bone marrow. Giving the patient their~     healthy stem cells will help their bone marrow make new stem cells that become red blood~     cells, white blood cells, and platelets.~      PURPOSE: This phase II trial is studying how well busulfan, melphalan, and thiotepa work in~     treating patients who are undergoing an autologous stem cell transplant for Hodgkin's or~     non-Hodgkin's lymphoma.~   "
253116|NCT00238420|"~     This phase I/II trial is studying the side effects of giving paclitaxel together with~     radiation therapy with or without trastuzumab and to see how well it works to kill any~     remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used~     in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive~     to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel~     together with radiation therapy and trastuzumab may kill more tumor cells. Giving these~     treatments after surgery may kill any remaining tumor cells.~   "
253117|NCT00238407|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and~     cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and~     cisplatin together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together~     with radiation therapy works in treating patients with locally advanced esophageal cancer~     that cannot be removed by surgery.~   "
253118|NCT00238394|"~     AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial~     is studying how well AZD2171 works in treating patients with locally advanced or metastatic~     liver cancer.~   "
253119|NCT00238381|"~     RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep~     some of their bowel function. It is not yet known which method of rectal reconstruction is~     most effective after surgery.~      PURPOSE: This randomized phase III trial is studying three different methods of rectal~     reconstruction to compare how well they work in treating patients who are undergoing surgery~     for rectal cancer.~   "
253120|NCT00238368|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy with an~     autologous stem cell or bone marrow transplant may allow more chemotherapy to be given so~     that more cancer cells are killed. Procedures, such as fludeoxyglucose F 18 positron emission~     tomography (FDG-PET) (done during chemotherapy) may help doctors predict a patient's risk of~     relapse and help plan the best treatment.~      PURPOSE: This phase II trial is studying how well FDG-PET works in predicting risk of relapse~     in patients with aggressive non-Hodgkin's lymphoma who are undergoing combination~     chemotherapy with or without autologous stem cell or bone marrow transplant.~   "
253121|NCT00238355|"~     RATIONALE: Voriconazole and caspofungin acetate may control invasive fungal infections in~     patients who have weakened immune systems.~      PURPOSE: This phase II trial is studying how well giving voriconazole together with~     caspofungin acetate works in treating invasive fungal infections in patients with weakened~     immune systems.~   "
253122|NCT00238342|"~     RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has~     ovarian cancer.~      PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing~     ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass.~   "
253123|NCT00238329|"~     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological~     therapies, such as thalidomide, may stimulate the immune system in different ways and stop~     tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of~     melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with~     thalidomide may be an effective treatment for melanoma.~      PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with~     thalidomide works in treating patients with recurrent or metastatic melanoma.~   "
253124|NCT00238316|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of letrozole may stop cancer from forming or coming back in~     postmenopausal women who are at increased risk for breast cancer due to high breast density.~      PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing~     breast cancer in postmenopausal women who are at increased risk for breast cancer due to high~     breast density.~   "
253125|NCT00238303|"~     This phase II trial is studying how well vorinostat works in treating patients with~     progressive or recurrent glioblastoma multiforme. Drugs used in chemotherapy, such as~     vorinostat, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~     Giving it after surgery may kill any remaining tumor cells.~   "
253126|NCT00238290|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Estrogen can cause the growth of~     breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the~     amount of estrogen the body makes. Giving trastuzumab together with letrozole after disease~     progression may be an effective treatment for breast cancer.~      PURPOSE: This phase II trial is studying how well giving trastuzumab together with letrozole~     works in treating postmenopausal women with progressive advanced breast cancer.~   "
253127|NCT00238277|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide during and~     after radiation therapy may kill any tumor cells that remain after surgery and placement of~     Gliadel wafers.~      PURPOSE: This phase II trial is studying how well giving temozolomide during and after~     radiation therapy works in treating patients who have undergone previous surgery and~     placement of Gliadel wafers for newly diagnosed glioblastoma multiforme.~   "
253128|NCT00238264|"~     RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may~     kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This phase II trial is studying how well radiation therapy works in treating young~     patients with gliomas.~   "
253129|NCT00238251|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving radiation~     therapy together with either gefitinib or temozolomide may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving radiation therapy~     together with either gefitinib or temozolomide works in treating patients with non-small cell~     lung cancer and brain metastases.~   "
253130|NCT00238238|"~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Biological therapies, such as lenalidomide,~     may stimulate the immune system in different ways and stop cancer cells from growing.~     Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the~     cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This~     randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating~     patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.~   "
253131|NCT00238225|"~     RATIONALE: Calcitriol may cause solid tumor cells to look more like normal cells, and to grow~     and spread more slowly. Ketoconazole and dexamethasone may help calcitriol work better by~     making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole~     and dexamethasone may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of calcitriol when~     given together with ketoconazole and dexamethasone in treating patients with metastatic or~     unresectable solid tumors.~   "
253132|NCT00238212|"~     This phase II trial is studying how well sorafenib works in treating patients with~     unresectable or metastatic gallbladder cancer or cholangiocarcinoma. Sorafenib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking~     blood flow to the tumor~   "
253133|NCT00238199|"~     RATIONALE: Calcitriol may cause pancreatic cancer cells to look more like normal cells, and~     to grow and spread more slowly. Drugs used in chemotherapy, such as docetaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Calcitriol may also help docetaxel work better by making the tumor cells~     more sensitive to the drug. Giving calcitriol together with docetaxel may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving calcitriol together with docetaxel~     works in treating patients with metastatic or locally advanced pancreatic cancer.~   "
253134|NCT00238173|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, etoposide phosphate, and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells. Mannitol may help chemotherapy work better by making it easier for~     these drugs to get to the tumor. Chemoprotective drugs, such as acetylcysteine and sodium~     thiosulfate, may protect normal cells from the side effects of chemotherapy. Giving~     acetylcysteine together with mannitol, combination chemotherapy, and sodium thiosulfate may~     be an effective treatment for malignant brain tumors.~      PURPOSE: This phase I trial is studying the side effects and best dose of acetylcysteine when~     given together with mannitol, combination chemotherapy, and sodium thiosulfate in treating~     children with malignant brain tumors.~   "
253135|NCT00238160|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells.~     Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known~     whether surgery and hepatic arterial chemotherapy are more effective than surgery alone in~     treating patients with liver cancer that has spread to the portal vein.~      PURPOSE: This randomized phase III trial is studying surgery and hepatic arterial~     chemotherapy to see how well they work compared to surgery alone in treating patients with~     liver cancer that has spread to the portal vein.~   "
253136|NCT00238147|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, carboplatin, and capecitabine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine~     may also make tumor cells more sensitive to radiation therapy. Giving combination~     chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when~     given together with carboplatin and capecitabine followed by chemoradiotherapy in treating~     patients who are undergoing surgery for locally advanced esophageal cancer.~   "
253137|NCT00238121|"~     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. This phase II trial is studying how well~     sorafenib works in treating patients with advanced or recurrent uterine cancer.~   "
253138|NCT00238108|"~     This study will evaluate the effectiveness of treatment with melatonin supplements in~     improving sleep in individuals with high blood pressure who are taking beta-blockers.~   "
253139|NCT00238082|"~     This is an investigator-sponsored research study to evaluate if treatment with HFA-134a~     beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway~     remodeling or scarring in subjects with COPD. Approximately 20 subjects with COPD will~     participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with~     HFA-134a and 10 receiving a placebo.~   "
253140|NCT00238069|"~     This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep~     apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep~     apnea will reduce this inflammation, and improve asthma control. This study will help us~     better understand what happens to the lung and bronchial tubes before and after treatment of~     sleep apnea, which could benefit all patients with sleep apnea. This study involves 2~     bronchoscopies.~   "
253141|NCT00238056|"~     30 premature infants treated by domperidone upon decision of the attending neonatologist will~     have a daily recording of electrocardiogram for the first 7 seven days of treatment, and~     pharmacokinetics dosages at Day 7. Their ECG will be compared to 30 non treated premature~     infants, matched for gestational age, postnatal age and sex.~   "
253142|NCT00238043|"~     The purpose of this study is to establish the long-term safety and efficacy of Biogeneric~     Epoetin, the attainability of therapeutic target for anaemia management, and the impact of~     Epoetin treatment on long-term health outcome and its cost effectiveness.~   "
253143|NCT00238030|"~     To compare oral versus intravenous administration of thyroid hormone: 1) for reversibility of~     hemodynamic instability in organ donors, and, 2) the pharmacokinetics of oral vs iv thyroid~     administration~   "
253144|NCT00238017|"~     The purpose of this study is to compare the efficacy and safety of two antimalarial drug~     regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with~     uncomplicated malaria. Also, genetic host factors which might influence efficacy and/or~     safety will be examined.~   "
253145|NCT00238004|"~     Abnormal blood cholesterol levels increase the risk of developing, or dying from heart~     disease. It is well recognised that if harmful LDL cholesterol is high, and protective~     HDL cholesterol is low, this risk is increased. Drugs called statins are routinely used in~     patients with heart disease, are well tolerated, and decrease the harmful LDL cholesterol~     levels. However, statins only increase protective HDL cholesterol to a small extent. Some~     patients may thus benefit from additional medication to increase protective HDL-cholesterol~     further. One of the most effective drugs which can do this is nicotinic acid. This drug is~     well established having been available for over 30 years. Previous use has been limited by~     facial flushing in a large percentage of patients receiving the drug. However a new~     formulation called Niaspan is now available which is associated with much less flushing.~     Although many patients will have transient flushing, it is estimated that only 1 patient out~     of every 20 receiving the drug will have to discontinue treatment. We therefore propose, in~     patients with coronary artery disease and low HDL cholesterol despite being on a statin, to~     study the effect of Niaspan on HDL cholesterol and other lipid parameters, and to assess its~     tolerability.~   "
253146|NCT00237991|"~     GlaxoSmithKline Korea has submitted a registration file for its hepatitis A vaccine. The~     present study will collect clinical data in the local target population as per the~     requirement of Korean Food and Drugs administration (FDA).~   "
253147|NCT00237978|"~     The aim of the study is to investigate the effectivity of visible light in combination with~     waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and~     non-inflammatory lesions within 8 weeks will be measured and compared with the standard~     treatment with Adapalene.~   "
253148|NCT00237965|"~     This study aims to improve Skin Self-Examination accuracy by a simple cost effective~     intervention requiring participants to complete a mole-mapping diagram.~   "
253149|NCT00237952|"~     Background The relationship between long-term heavy lead exposure and chronic interstitial~     nephropathy is well recognized in the previous literatures. Several epidemiological studies~     have demonstrated a positive association between blood lead levels and the age related~     decreases of renal function in the general population and suggested that environmental~     low-level lead exposure may accelerate the progression of renal function in the healthy~     persons. In addition, previous our works suggest environmental lead exposure may correlate to~     progressive renal insufficiency and lead chelation therapy or repeated lead chelation may~     improve and slow the progressive renal insufficiency in non-diabetic patients with chronic~     renal diseases. However, Diabetes mellitus is increasing in prevalence worldwide and is~     currently estimated to affect more than 6.5 percent of the population of the United States.~     In addition, diabetes is the most common cause of end-stage renal disease in many countries,~     accounting for about 40 percent of cases. It is still unknown that the relationship between~     long-term environmental lead exposure and the progressive renal insufficiency in patients~     with type II diabetes and diabetic nephropathy.~      Methods Ninety patints with type II diabetes and diabetic nephropathy (serum creatinine~     levels between 1.5 mg per deciliter and 3.9 mg per deciliter) who have a normal body lead~     burden and no history of exposure to lead or other metals will be observed for 24 months.~     Then, about 50 subjects with high normal body lead burdens (at least 80 μg but less than 600~     μg) will be randomly assigned to the study and control groups. For three months, the 25~     patients in the study group will receive lead-chelation therapy with calcium disodium EDTA~     weekly until the body lead burden fallsl below 50 μg, and the 25 control group receive weekly~     placebo. During the ensuing 12 months, the renal function will be regularly followed up every~     3 months and EDTA mobilization tests will be assessed every 6 months. If body lead burden of~     the study group patients increase more than 60μg, the chelation therapy will be performed~     again until their body burden are less than 60 μg. The primary end point is an increase in~     the serum creatinine level to 2 times the base-line value during the observation period. A~     secondary end point is the change in renal function during the follow up period.~   "
253150|NCT00237939|"~     The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be~     effective, safe and well tolerated in the treatment of patients with schizophrenia who are~     treated in a general psychiatric setting.~   "
253151|NCT00237926|"~     The purpose of this study is to compare the health outcomes of a 12-week exercise program~     focused on aerobic training (using a treadmill) to a 12-week exercise program focused on~     resistance training (using Thera-Bands) in sedentary patients within 6 months of completing~     treatment for cancer.~   "
253152|NCT00237913|"~     Aripiprazole will show improved effectiveness over the standard of care treatment with one of~     three atypical antipsychotics (olanzapine, quetiapine and risperidone).~   "
253153|NCT00237900|"~     To assess safety, efficacy and explorative objectives of gefitinib in combination with~     chemoradiation in resectable gastric cancer~   "
253154|NCT00237887|"~     A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects~     with Moderate to Severe Chronic Plaque Psoriasis~   "
253155|NCT00237874|"~     We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the~     schizophrenia prodrome when they are prescribed aripiprazole.~   "
253156|NCT00237861|"~     This study will compare the effectiveness of newer atypical antipsychotics versus older~     conventional antipsychotics in treating schizophrenia.~   "
253157|NCT00237848|"~     This study will examine the effectiveness of D-serine in increasing and sustaining the~     benefits of cognitive retraining in people with schizophrenia.~   "
253158|NCT00237822|"~     The investigators are proposing a study of treatment adherence in co-occurring psychiatric~     and drug use disorders (COD). The proposed study uses a 3-cell/condition design, within which~     75 adult outpatients with co-occurring psychiatric disorders and drug abuse/dependence~     (CODDA) will be randomly assigned to one of the following brief, 8-week, manual-guided~     interventions following a 2-week Assessment Only baseline period:~        1. Adherence Feedback (AF); this condition will entail weekly, 20-25 minute sessions of AF,~          which is a procedure that represents a technological advancement developed by Cramer et~          al. (1989, 1995, and 1999) and is based on the use of adherence data from the~          microelectronic monitor in Medication Event Monitoring System (MEMS) caps,~        2. AF + Contingency Management (AF + CM); in this condition, participants will receive AF,~          as described above, PLUS contingency management. CM is based on the behavioral learning~          theory, which suggests that the occurrence of a behavior is increased as a function of~          the rate at which it is positively reinforced or rewarded, or~        3. AF + Motivational Enhancement Therapy (AF + MET); in this condition, patients will~          receive AF, as described above, PLUS motivational enhancement therapy. MET is based on~          the idea that an effective way to motivate behavior change is to assist patients in~          clarifying their ambivalence (i.e., reasons for and against changing/adhering),~          utilizing a series of strategies based on client-centered psychotherapy, self-efficacy~          theory, and social psychology.~      The study will allow the evaluation of three hypotheses:~        1. AF + MET is superior to AF + CM,~        2. AF + MET is superior to AF alone, and~        3. AF + CM is superior to AF alone.~      Primary outcome measures are:~        1. rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or~          SSRIs), as measured by MEMS caps and self-report,~        2. rates of counseling attendance, and~        3. reductions in illicit drug use, including achievement of abstinence, as assessed by~          twice-weekly urine toxicology tests and self-report.~      Secondary outcomes include reductions in psychiatric symptomatology and rates of~     re-hospitalization. The investigators will also evaluate the relationship between adherence~     and primary and secondary outcomes.~   "
253159|NCT00237809|"~     This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA)~     receptor function in the brain and thereby increasing the capacity of the brain to both form~     new connections and strengthen existing connections, schizophrenic patients may derive both~     greater and sustained benefit from cognitive retraining.~   "
253160|NCT00237796|"~     The primary purpose of this project is to evaluate the efficacy of a group therapy~     intervention, cognitive behavioral social skills training (CBSST), that teaches social~     functioning skills and cognitive-behavioral compensatory aids to older patients with~     schizophrenia. CBSST, therefore, targets the multidimensional deficits that lead to~     disability in aging veterans with severe mental illness.~   "
253161|NCT00237783|"~     Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis~     patients. In this pilot study, we will evaluate the safety and effects of individualizing the~     sodium concentration in the dialysate according to the patient's own plasma sodium levels. We~     hypothesize that patients will have less thirst and less weight gain during the intervention~     leading to easier fluid removal and less episodes of hypotension.~   "
253162|NCT00237770|"~     The aim of this investigation is to determine the blood pressure response to NOS inhibition,~     with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to~     establish if blood pressure can be increased while upright in those with tetraplegia. If~     blood pressure is increased with NOS inhibition in persons with tetraplegia, this would~     improve our treatment of the condition of low blood pressure during seated postures in~     individuals with tetraplegia.~   "
253164|NCT00237744|"~     The long-range goal of this work is to identify how to target treatment so that the brain is~     functionally re-organized to produce movement. This study will compare treatment response to~     robotics versus functional neuromuscular stimulation.~   "
253165|NCT00237731|"~     Efficacy and safety of morphine titration on acute pain in emergency medical mobile units~     with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus~     of 0.05 mg/kg plus 0.025 mg/kg~   "
253166|NCT00237718|"~     Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood~     markers which their body makes in response to increased stress and injury. An increase in~     these markers have been shown to be related to cardiovascular disease and death in ESRD~     patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic~     acid) may decrease these markers.~   "
253167|NCT00237705|"~     Concussion is defined as any temporary disturbance in brain function following a blow to the~     head. It may not involve a loss of consciousness and usually results in a post concussive~     headache (PCH) immediately after the injury. Between 30 and 50 percent of patients with~     concussion will develop postconcussive syndrome (PCS) consisting of symptoms such as~     headache, and a variety of other debilitating symptoms lasting several weeks to months.~      The objective of this study is to determine if metoclopramide, a drug commonly used in the~     treatment of migraine headache, will be effective in relieving PCH and in preventing PCS.~      Eligible patients will have a history of a concussion resulting in headache within the past~     24 hours. Patients will rate their pain on a standard scale before and after being treated~     with one or two intravenous doses of either metoclopramide or saltwater placebo. They will be~     contacted by telephone 1, 4 and 8 weeks later in order to determine if they have developed~     the postconcussive syndrome.~   "
253168|NCT00237692|"~     There are 65 million Americans and over 8.5 million veterans who have been diagnosed with~     hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under~     effective control (less than 140/90 mm/Hg). Uncontrolled hypertension greatly increases the~     risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal~     failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension~     and the availability of well-defined therapies and widely accepted target values for BP,~     interventions to improve BP control have had limited success.~   "
253169|NCT00237679|"~     The diagnosis and management of childhood dysphonia is a significant clinical problem;~     however, there have been few studies aimed at defining standard assessment methods for~     pediatric dysphonia. Accordingly, pediatric dysphonia is difficult to diagnose and it is~     difficult to quantify change following treatment. The long-term goal of this research program~     is to develop valid, responsive, reliable, and age-appropriate methods for assessing vocal~     pathology in children. In the present small grant, our objective is to define assessment~     methods that are appropriate for use in determining response to treatment. Our main focus,~     therefore, is the issue of assessment responsivity. The first specific aim is to develop a~     set of responsive measures of vocal pathology in school-aged children by inducing short-term~     change in vocal status via behavioral and medical management of extraesophageal reflux~     disease (EERD). Because we are treating children suspected of EERD, this study also presents~     the opportunity for examining the benefits of combined vocal hygiene and medical management~     in the treatment of pediatric EERD. Accordingly, our second specific aim is to determine~     predictive criteria for improvement in vocal status in dysphonic children suspected of EERD.~     Our hypothesis is that a particular set of measurements will emerge as particularly~     responsive to change in vocal pathology in this population, and will allow for informed~     prediction of degree of improvement with treatment. The proposed research is significant in~     filling a gap in knowledge in childhood dysphonia assessment and treatment, which are~     important clinical issues consistent with the mission and intent of the NIDCD. Because~     phonatory disorders in children may have lasting negative effects, studies geared toward~     accurate assessment and treatment are very important.~   "
253170|NCT00237666|"~     The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the~     treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a~     major depressive episode.~   "
253171|NCT00237653|"~     The main objective of this study is to demonstrate the relevance of Valganciclovir on~     recurrent bouts of cryptogenic inflammatory bowel diseases with infection by cytomegalovirus~     (CMV). The goal is to obtain 90% (for Valganciclovir treated patients) versus 50% (for~     placebo treated patients) remission at 3 months (including the discontinuation of corticoids~     or reducing their dose to under 20 mg of prednisone equivalence), without any relapse over~     the 6 following months.~   "
253172|NCT00237640|"~     The purpose of this study is to determine the effects of cinnamon on serum glucose and lipid~     levels in people with non-insulin dependent type 2 diabetes mellitus.~   "
253173|NCT00237627|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome together with~     bortezomib may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when~     given together with doxorubicin hydrochloride liposome and to see how well they work in~     treating patients with refractory hematologic cancer or malignant solid tumor or metastatic~     breast cancer.~   "
253174|NCT00237614|"~     Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for~     renal injury due to the toxic effect of contrast agents. Patients developing renal~     dysfunction after primary angioplasty have worse outcome. To investigate the role of the~     antioxidant N-acetylcysteine (NAC) in preventing renal injury in angioplasty, we randomized~     352 consecutive patients undergoing primary angioplasty into three groups: the first group~     received NAC at standard dose (NAC group, 600 mg i.v. bolus before primary angioplasty,~     followed by oral 600 mg twice daily for the following 48 hours; n=115), the second group~     received NAC at double dose (DD-NAC group; 1,200 mg i.v. bolus and oral 1,200 mg twice daily~     for 48 hours; n=118), and the last group received placebo (controls; n=119).~   "
253202|NCT00237250|"~     The purpose of this study is to assess the safety and effectiveness of vildagliptin, an~     unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people~     with pre-diabetes who have high blood sugar levels after meals.~   "
253175|NCT00237601|"~     In the Netherlands, which has about 200.000 births per year, maternity care is provided by~     midwives or general practitioners unless medical reasons necessitate specialist obstetric~     care. Women with low risk pregnancies are free to decide where to give birth, attended by~     their midwife or general practitioner, at home or in the hospital, from which they are then~     discharged within 24 hours. In the Netherlands these hospital births are referred to as~     poliklinische bevallingen (i.e. outpatient deliveries) to indicate that they do not involve~     formal hospitalisation, or as verplaatste thuisbevalling (i.e. relocated home births) to~     indicate that they are supervised by the same caregivers as the home births without~     involvement of specialist obstetricians.~      In the last two decades a marked increase in the referral rate to obstetricians during~     childbirth has occurred, especially for nulliparae, both in planned home births and planned~     hospital births (outpatient deliveries). 90% from all primigravidae will start their~     pregnancy under care of the primary caregiver (midwife of general practitioner). During the~     pregnancy 30% will be referred to the secondary caregiver (obstetrician specialist). The~     other 60% will start labor guided by the primary caregiver. More than 50% of these women will~     be referred to the obstetrician during labor.~      Despite this unique situation of the Dutch maternity care, the differences between home and~     hospital birth (outpatient deliveries) with regard to effectivity and efficiency have never~     been investigated. It is also unclear if pregnant women are informed about a 50% risk of~     being transported to the secondary caregiver/ hospital during labor at home. Neither do we~     know what their experiences are.~      This study aims to investigate the differences between home and hospital deliveries under~     care of the primary caregiver with regard to effectivity (costs) and efficiency (patient~     satisfaction) of care.~   "
253176|NCT00237588|"~     To determine if angiotensin-II AT-1 receptor blockade(ARB) may improve insulin sensitivity~     assessed by the hyperinsulinaemic isoglycaemic glucose clamp, more than CCB therapy at a~     comparable dose with regards to the blood pressure-lowering effect.~   "
253177|NCT00237575|"~     The main objective of this study is to compare the effectiveness of Leukine & Neupogen to~     decrease the incidence of grade 3 & 4 neutropenia in the treatment of patients receiving~     cisplatin & gemcitabine for urothelial (bladder) cancer.~      All patients will receive chemotherapy with cisplatin plus gemcitabine in six 21-day cycles.~     Patients will also receive either Leukine (Arm A) or Neupogen (Arm B).~      Patient Population: 100 patients will be enrolled (n=100) in this study. Patients cannot have~     undergone previous chemotherapy. Approximately 50 patients will be enrolled into each~     treatment arm.~      Test Product, Dose, Mode of Administration: All patients will receive chemotherapy treatment~     with cisplatin (70 mg/kg) on Day 1 and gemcitabine (1000 mg/m2) on Days 1, 8, & 15 of each~     21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen~     (5 µg/kg) injected under the skin on Days 2-6, 9-13, & 16-20 of each cycle.~      Duration of Treatment: Patients will receive a maximum of six 21-day cycles of treatment. The~     overall trial, including follow-up, is expected to be 3 years in duration.~   "
253178|NCT00237562|"~     1. Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a~          multi-ethnic population of women;~        2. Set up an efficient system for interpretation of Pap smears for patients in the SVP that~          will minimize waiting time;~        3. Determine the follow-up rates and compare them between women assigned to the SVP and a~          usual care program (UCP);~        4. Determine satisfaction and compare it between women assigned to the SVP and the UCP;~        5. Determine the cost-effectiveness and compare it between the SVP and UCP~   "
253179|NCT00237549|"~     The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment~     compared to standard treatment.~        1. In the screening study, the feasibility and results of country specific models to~          identify undiagnosed individuals with Type 2 diabetes will be evaluated.~        2. In the treatment study the effects of routine care in general practice according to~          local and national guidelines will be compared with an intensive ADDITION protocol,~          including structured lifestyle education (dietary modification, increased physical~          activity and smoking cessation) and intensive treatment of blood glucose, blood pressure~          and lipids, and prophylactic aspirin with or without motivational interviewing, on~          mortality, macrovascular and microvascular disease. Furthermore the impact of treatment~          on health status, treatment satisfaction and health service costs will also be assessed.~   "
253180|NCT00237536|"~     The purpose of this trial is to evaluate the dose response relationship of lonidamine and the~     primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with~     symptomatic benign prostatic hyperplasia (BPH).~   "
253181|NCT00237523|"~     -  History of clinical breast pain for at least the last six months.~        -  At least six days of moderate or severe breast pain per cycle.~        -  Fibrosis, cysts, nodules involving at least 25% of the surface of one breast.~        -  Euthyroid with no prior history of thyroid disease.~        -  Six months of daily therapy with molecular iodine.~        -  Placebo controlled vs active (1:1).~   "
253182|NCT00237510|"~     This study is based on the hypothesis that terazosin, a blocker of alpha-1 receptors, will be~     effective in reducing excessive sweating caused by antidepressant treatment, and will have~     minimal adverse effects.~   "
253183|NCT00237497|"~     The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily~     (QD), compared to placebo with Zopiclone in adults with chronic insomnia~   "
253184|NCT00237484|"~     This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label,~     controlled pilot trial designed to evaluate the effect of infliximab induction therapy on~     sustained virologic response (SVR) to treatment with pegylated interferon alfa-2b plus~     ribavirin in a group of 96 therapy-naïve subjects with genotype 1 hepatitis C virus (HCV)~     infection and high serum tumor necrosis factor (TNF)-alpha values.~   "
253185|NCT00237471|"~     To determine whether tight glycaemic control with insulin improves myocardial function and~     myocardial perfusion (measured by myocardial contrast echocardiography) and novel vascular~     risk factors in patients with acute myocardial infarction and hyperglycaemia.~   "
253186|NCT00237458|"~     This trial is the follow-on trial to a preceeding open-label trial which included patients~     with chronic refractory neuropathic pain. It is conducted at one site in the United Kingdom~     and the patient enrollment is completed. The patients had successfully completed the above~     mentioned trial and, in the investigator's opinion, would benefit from long-term~     administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to~     their optimal dose and then continued into the maintenance phase. Different pain qualities~     are assessed by a patient's diary.~   "
253187|NCT00237445|"~     A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal~     resistance comparing the clinical efficacy and health outcomes of outpatients with mild to~     moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for~     7 days, or azithromycin once daily for 5 days~   "
253238|NCT00236769|"~     The purpose of the study is to evaluate the contraceptive efficacy, safety, cycle control,~     and compliance with the transdermal contraceptive system.~   "
253188|NCT00237432|"~     The purpose of this study is to investigate the mechanism of a successful immune response to~     hepatitis C virus (HCV) infection. Currently, it is believed that the immune system is~     involved in responding to HCV infection, but how it is involved is not known. It is estimated~     that 30% of individuals infected with HCV are able to clear the virus without treatment,~     while 70% progress to chronic infectious. By studying the immune responses in these two~     populations, we, the researchers at Rockefeller University, hope to gain insight into the~     mechanisms of the immune response and develop new strategies for HCV therapy.~   "
253189|NCT00237419|"~     Ankylosing spondylitis (AS) is a chronic inflammatory disease that involves the sacroiliac~     joints, axial skeleton, entheses and peripheral joints. Current therapy for AS is mainly~     NSAIDs and physiotherapy which are oft insufficient. Treatment with the TNF-alpha blocking~     agent infliximab was shown to have definite clinical efficacy in patients with active AS on a~     short- and a long-term-basis over 2 years. We want to show that treatment with infliximab on~     a long-term basis over 4 years is safe and efficient and can prevent radiographic progression~     over a long period of time. Further we want to learn about the outcome after discontinuation~     of anti-TNF-alpha therapy.~   "
253190|NCT00237406|"~     This study is designed to test whether a telephone call-in program is a feasible way to~     collect mood and drug-related information in individuals enrolled in a methadone maintenance~     program.~   "
253191|NCT00237393|"~     The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.~   "
253192|NCT00237380|"~     In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation~     (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator~     (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF~     due to a nonsense mutation. The main purpose of this study is to understand whether PTC124~     can safely increase functional CFTR protein in the cells of patients with CF due to a~     nonsense mutation.~   "
253193|NCT00237367|"~     The purpose of the study is to compare the pharmacodynamics (the way a drug works in the~     body) of rabeprazole and pantoprazole on intragastric acidity and esophageal acid exposure in~     gastroesophageal reflux disease (GERD) patients with nighttime heartburn. Patients will be~     given one dose of each medication with a washout period of 6 to 13 days between doses~     (washout period means they will receive no further proton pump inhibitor medication for~     6-13 days, allowing the 1st dose to completely leave their bodies). Rabeprazole is approved~     in the United States for the short-term treatment (4-8 weeks) in the healing and symptomatic~     relief of erosive or ulcerative GERD with symptoms of daytime or nighttime heartburn,~     maintenance of healing of erosive or ulcerative GERD, and treatment of symptomatic GERD. The~     dosage regimen for all GERD indications is 20 mg once a day. Other indications include~     healing of duodenal ulcers, Helicobacter pylori eradication to reduce the risk of duodenal~     ulcer recurrence, and treatment of pathological hypersecretory conditions including~     Zollinger-Ellison Syndrome. The most common side effect of rabeprazole is headache. In~     clinical trials headache was assessed as possibly related to rabeprazole in 2.4% of subjects~     vs. 1.6% for placebo. Pantoprazole at a dose of 40 mg once a day is indicated for the~     short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive~     esophagitis, and the maintenance of healing of erosive esophagitis and reduction in relapse~     rates of daytime and nighttime heartburn symptoms in patients with GERD. Other indications~     include pathological hypersecretory conditions including Zollinger-Ellison Syndrome. The most~     common side effects are headache and diarrhea.~   "
253194|NCT00237354|"~     The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the~     treatment of recurrent breast carcinoma. This study will also include a preliminary~     assessment of response of injected lesions by histologic assessment upon lesion excision at~     1-3 weeks following IL PV-10 administration. Post-excision wound healing will be assessed~     clinically at 1 week and 4 weeks following excision of PV-10 injected lesions.~   "
253195|NCT00237341|"~     The purpose of this study is to assess physical functionality changes over a minimum of 9~     weeks in patients with non-malignant chronic low back pain who are taking short-acting~     opioids (narcotic pain medications) for 4 or more weeks, and who start taking the long-acting~     opioid fentanyl in the form of a transdermal (skin) patch.~   "
253196|NCT00237328|"~     Heparin is a drug that is widely used to prevent and treat blood clotting. Individuals~     undergoing cardiopulmonary bypass surgery are administered high doses of heparin, and some of~     them develop antibodies to the drug. This immune response can lead to the formation of blood~     clots, setting the stage for a potential heart attack or stroke. The purpose of this study is~     to evaluate how often an immune response to heparin leads to the formation of blood clots in~     individuals who have had heart surgery.~   "
253197|NCT00237315|"~     Urea cycle disorders (UCD) are a group of rare inherited metabolism disorders. Infants and~     children with UCD commonly experience episodes of vomiting, lethargy, and coma. The purpose~     of this study is to perform a long-term analysis of a large group of individuals with various~     UCDs. The study will focus on the natural history, disease progression, treatment, and~     outcome of individuals with UCD.~   "
253198|NCT00237302|"~     The purpose of this study is to assess the safety and efficacy of topiramate as compared to~     placebo in preventing migraines in children.~   "
253199|NCT00237289|"~     The purpose of this study is to assess the efficacy and safety of adding topiramate as~     compared to placebo to the medications a patient with bipolar disorder is already taking~     (lithium or valproate) to see if adding topiramate will better control the patient's manic~     symptoms.~   "
253200|NCT00237276|"~     The study looks at 2 hypotheses in 2 patient groups:~        1. Are more experienced endoscopists better at detecting subtle lesions (polyps) on the~          lining of the colon (large bowel) than less experienced endoscopists?~        2. Do existing and new techniques that can highlight lesions on the lining of the bowel~          improve endoscopists ability to spot them? This will be tested using video footage of~          endoscopies from 2 patient groups: those with a normal colon linig and those with~          colitis (bowel lining inflamation)~   "
253201|NCT00237263|"~     The purpose of this study is to evaluate the safety and efficacy of the long-term treatment~     of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.~      This study is not recruiting patients in the United States.~   "
253203|NCT00237237|"~     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a~     single oral drug. The purpose of this study is to assess the long-term safety and~     effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in~     lowering overall blood glucose levels when added to metformin in people with type 2 diabetes~     not at target blood glucose levels on metformin alone.~   "
253204|NCT00237224|"~     To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily~     dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.~   "
253205|NCT00237211|"~     To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in~     postmenopausal patients with breast cancer, and to determine the blood concentrations of~     letrozole and hormones.~   "
253206|NCT00237198|"~     -  Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy~          in postmenopausal patients with advanced breast cancer who received previous~          anti-estrogen treatment~        -  To investigate changes in blood drug concentrations and blood hormone kinetics.~        -  To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of~          letrozole~   "
253207|NCT00237185|"~     In the core study, participants with unresectable or metastatic gastrointestinal stromal~     tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3~     years. The 10 year extension study allowed participants, who successfully completed the core~     study, to continue study treatment with imatinib mesylate provided they still benefited from~     treatment and did not demonstrate safety concerns as per the investigator's opinion.~   "
253208|NCT00237172|"~     This is a extension study of CSTI571B1201 study~   "
253209|NCT00237159|"~     It is the aim of this clinical study to evaluate the skeletal-related event rate and~     tolerability of zoledronic acid in patients with prostate cancer patients and bone~     metastases.~   "
253210|NCT00237146|"~     An open, multicenter and prospective study to evaluate the impact of the treatment with~     zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with~     prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is~     given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event~     occurs.~   "
253211|NCT00237133|"~     Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for~     patients with locally advanced breast in postmenopausal women expressing hormonal receptors (~     ER and PR)~   "
253212|NCT00237120|"~     This study will assess the safety and efficacy of imatinib in newly enrolled previously~     untreated patients with chronic phase CML.~   "
253213|NCT00237107|"~     The aim of this study was to compare histologically observed tumour infitration of basal cell~     carcinoma (bcc) lesions before and after curretage.A significant reduction of tumour depth~     would enable further bcc's included for superficial non-invasive treatment modalities such as~     topical photodynamic therapy.~   "
253214|NCT00237094|"~     Studies have demonstrated that intensive disease management of diabetes and its associated~     risk factors, hypertension and dyslipidemia, can prevent the progression of vascular~     complications. However, implementation of well defined guidelines for intensive disease~     management has been suboptimal. Barriers to success occur at multiple levels, including~     health care systems, health care providers and patients.~      In rural regions of the U.S., reduced availability of primary care providers and specialty~     services, including diabetes education, present additional barriers to effective diabetes~     care. Use of a nurse practitioner led interdisciplinary team to intensively manage urban and~     rural diabetic patients, utilizing telehealth technology to provide care to rural areas, will~     help begin to address these barriers~      The long term goal of the project is to develop a practical and sustainable system of~     intensive diabetes management that will be effective in helping diabetic patients achieve and~     maintain goals within established treatment guidelines regardless of geographic location.~      Specific aims are:~        1. To determine in both urban and rural areas if a nurse practitioner led team approach to~          intensive diabetes management and education improves disease-specific outcomes and~          patient education compared to traditional care (current diabetes management of urban~          patients).~        2. To determine if telehealth is an effective and accepted mechanism for delivery of a~          nurse practitioner led team approach to intensive diabetes management and education in~          rural areas.~        3. To determine if a nurse practitioner led intensive disease management team can identify~          patient risk factors (psychological, financial, and work-related factors) that may be~          barriers to patient adherence, earlier in the management of urban diabetic patients~          compared to traditional care.~        4. To compare volume and type of service utilization of a nurse practitioner led team~          approach to diabetes management and education to that of traditional care in both urban~          and rural areas. Disease-specific outcomes will include physiologic variables (HbA1c,~          blood pressure, lipid levels), measurement and documentation of preventive services~          (dilated eye exam, monofilament exam, microabumin testing) and patient's knowledge of~          disease tested by questionnaire.~      Results should show improved outcomes and patient knowledge in urban and rural patients~     receiving intensive disease management compared to traditional care.~   "
253215|NCT00237081|"~     The cause of interstitial cystitis is unknown. However, it tends to run in some families~     suggesting that there may be a genetic susceptibility to the disease. For instance, the~     disease is found 17 times more commonly in first-degree relatives (parent, sibling, or child)~     of patients with interstitial cystitis than in the general population. Furthermore, if one~     twin has interstitial cystitis, the disease is much more common in identical co-twins than~     fraternal co-twins. This evidence suggests that, in some families, genes that make a person~     susceptible to interstitial cystitis are being passed from one generation to the next.~      The University of Maryland School of Medicine and the National Institutes of Health are~     performing a study to identify these genes for susceptibility for interstitial cystitis. This~     study is entitled the Maryland Genetics of Interstitial Cystitis (MaGIC) study. The MaGIC~     study will investigate several hundred families with two or more blood relatives with~     interstitial cystitis. The study will seek to find changes in genes that are found far more~     commonly in family members who have interstitial cystitis than in those who do not have the~     disease.Identifying these genes should lead to a better understanding of the cause of~     interstitial cystitis. Finding the cause is the first step to finding the cure.~      This is a national study which is conducted by telephone and mail, and in which you can~     participate entirely from your home.~   "
253239|NCT00236756|"~     The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on~     therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of~     epilepsy in which there are mixed types of seizures.~   "
253240|NCT00236743|"~     The purpose of this study is to evaluate the safety and effectiveness of oral topiramate as~     add-on therapy in children with uncontrolled partial onset seizures who are taking one or two~     standard anti-epileptic drugs.~   "
253241|NCT00236730|"~     The purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on~     therapy in patients with difficult to control partial onset seizures who are taking one or~     two standard anti-epileptic drugs.~   "
253242|NCT00236717|"~     The purpose of this study is to compare the effectiveness and safety of topiramate to~     standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.~   "
253216|NCT00237068|"~     Asthma and gastroesophageal reflux disease (GERD) are common disorders, which although are~     not usually lethal, both have high morbidity, and high healthcare costs. Recent studies have~     demonstrated that asthma and GERD often co-exists, and that this co-existence is more~     frequent than just chance. Therefore, studies that characterize associations between these~     conditions, and, help in the development of interventions will positively impact the outcomes~     of these patients, which are critically needed.~      Subjects that participate in this study are required to be between the ages of 4-11 years~     old. This protocol proposes to enroll 100 children with asthma, on inhaled steroids who have~     poor asthma control, defined on the basis of frequent symptoms, excessive beta-agonists use,~     or frequent asthma episodes.~      The purpose of this research study is to:~        1. Determine, whether children with symptomatic, poorly controlled, asthma assigned to~          treatment with a PPI( Proton Pump Inhibitor), have fewer asthma exacerbations than~          similar participants assigned to placebo for a similar duration of time~        2. Determine whether children treated with Lansoprazole ( i.e., proton pump inhibitor):~          have a longer time to first exacerbation, have improved lung function, improved asthma~          symptom scores, improved quality of life, decreased rescue inhaler use, or other asthma~          medications, reduced emergency room/urgent care/ physician office visits that are asthma~          related.~        3. Determine whether a subgroup of symptomatic asthmatics, who show a greater benefit from~          PPI's, can be identified.~   "
253217|NCT00237055|"~     Six sites of the Pediatric Inflammatory Bowel Disease Consortium (plus 2 additional sites)~     will participate in this study. The participating sites will be that of the Principal~     Investigator (PI), Emory University School of Medicine, Atlanta, GA (Benjamin D. Gold, MD);~     Texas Children's Hospital / Baylor College of Medicine (George Ferry, MD and Tony Olive, MD);~     Children's Hospital of Philadelphia, Philadelphia, PA (Bob Baldassano, MD); University of~     Chicago Children's Hospital, Chicago, IL (Barbara Kirschner, MD); University of California,~     San Francisco (Mel Heyman, MD); Mass General Hospital / Harvard University (Harland Winter,~     MD); V.A. Stanford University School of Medicine, Stanford, CA (David Relman, MD); Children's~     Center For Digestive Healthcare, Atlanta, GA (Stanley Cohen, MD); and Centers for Disease~     Control and Prevention, Atlanta, GA (Drs. Jeannette Guarner, Siobhan O'Connor and Thomas~     Shinnick)~      The duration of study is 2 yrs.~      Objectives:~        1. Improve the methods to collect biopsies from the colon and ileum, tissue storage~          techniques and best methods to detect specific infections in children with Crohn's~          disease;~        2. Determine if there are specific infectious agents that are more common in children with~          Crohn's disease, and;~        3. Determine if there are types of children with Crohn's disease (e.g., children living in~          Boston, African American children) who may be more at risk for getting the infections.~      The study design involves children ages 6 months through 17 11/12 years of age who are~     undergoing a clinically-indicated colonoscopy. Subjects will be grouped into cases and~     controls.~        -  Any child ages 6 mos through 17 11/12 years of age, undergoing a clinically-indicated~          colonoscopy as determined by the treating physician, is eligible for enrollment. About~          500 patients will be enrolled in this study.~        -  Cases will consist of those children within the defined age group, who are undergoing~          diagnostic colonoscopy and have the definitive diagnosis of Crohn's disease.~        -  Children who have the diagnosis of indeterminate colitis or ulcerative colitis for the~          purpose of this R03, will be excluded as cases and from initial analysis, but will have~          tissue specimens banked for subsequent evaluation for infectious agents.~        -  Controls will consists of children within the defined age group, undergoing clinically~          indicated colonoscopy and who are not diagnosed with Crohn's disease, ulcerative colitis~          or indeterminate colitis (e.g., juvenile polyps, irritable bowel syndrome or functional~          bowel disease).~        -  Stool specimen (5ml/1 tsp) will be collected to test for different types of bacteria~        -  A questionnaire will be administered to each research volunteer.~        -  Each subject's medical information (i.e. diagnosis, disease stage, and laboratory~          results) will be stored electronically in a separate access-based database. A unique~          identifier will be assigned to each patient entered into the study and will also be used~          for blinding of the specimens analyzed by the pathologist and by molecular assays for~          infectious agents.~        -  Colonoscopy will be performed by the treating pediatric gastroenterologist and biopsies~          obtained in the usual standard of care.~        -  Clinical biopsies from the rectum, left, right, transverse colon and cecum will be~          placed in formalin containing vials as per standard of care for the clinical pathologist~          and diagnostic evaluation.~   "
253218|NCT00237042|"~     The purpose of this study is to determine whether treatments targeted to the hormonal factors~     and the cyclicity of TMD symptoms associated with the menstrual cycle are more effective in~     relieving TMD pain and symptoms than standard self management treatment.~   "
253219|NCT00237016|"~     Abstract Background Tick-Borne Relapsing Fever (TBRF) is an acute febrile illness. In Israel,~     TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks. We~     examined the safety and efficacy of a post exposure treatment policy to prevent TBRF.~      Methods In a double blind, placebo controlled trial 93 healthy volunteers with suspected tick~     exposure (51 with bite signs and 42 contacts) were randomly assigned to receive either~     Doxycycline (200 mg for the first day and 100mg/d for 4 days) or placebo, approximately 2~     days after contact. Blood smears were examined for Borrelia at inclusion and during fever~     rise. Serology for Lyme disease cross- reactivity and PCR for Borrelia GlpQ gene were also~     performed. Cases of TBRF were defined as subjects having fever and a positive blood smear.~   "
253220|NCT00237003|"~     The purpose of this study is to examine the efficacy of a brief motivational intervention for~     alcohol use in incarcerated women.~   "
253221|NCT00236990|"~     The purpose of this study is to evaluate the safety and effectiveness of ELMIRONÂ® in the~     treatment of chronic non-bacterial inflammation of the prostate gland.~   "
253222|NCT00236977|"~     To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in~     non-dialysis dependent, chronic renal failure in patients receiving or not receiving~     erythropoietin.~   "
253223|NCT00236964|"~     The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus~     erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic~     renal failure who are not receiving dialysis.~   "
253224|NCT00236951|"~     To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly,~     fixed doses of erythropoietin in patients who had or had not responded to erythropoietin~     therapy alone.~   "
253225|NCT00236938|"~     This is a open-label, prospective study comparing intravenous (IV) iron supplementation to~     standard care in anemic patents undergoing peritoneal dialysis.~   "
253226|NCT00236925|"~     This study is based on clinical findings that some patients with fibromyalgia have a tendency~     towards lower levels of the stress hormone cortisol. The hypothesis to be tested in this~     study is that the administration of a very low-dose of cortisol which has no side effects~     corrects this deficiency and results in an improvement of symptoms~   "
253227|NCT00236912|"~     The purpose of this study is to compare the efficacy and safety of two treatment regimens in~     treating patients with complicated appendicitis. Appendicitis requires antibiotic treatment~     when the appendix ruptures (complicated appendicitis). This is a study comparing intravenous~     (IV) antibiotic therapy of levofloxacin/metronidazole versus piperacillin/tazobactam for 4 to~     14 days. Patients may be switched to oral therapy after 48 hours, at the doctor's discretion.~   "
253228|NCT00236899|"~     Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate~     time to progression disease (PD).~   "
253229|NCT00236886|"~     The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy~     patients treated with topiramate.~   "
253230|NCT00236873|"~     The purpose of the study is to evaluate the efficacy and safety of topiramate in epilepsy~     patients with difficult to treat, partial-onset seizures who are taking one or two standard~     antiepileptic drugs.~   "
253231|NCT00236860|"~     The purpose of this study is to evaluate the efficacy and safety of topiramate as add-on~     therapy in epilepsy patients with difficult to treat, partial-onset seizures who are taking~     one or two standard anti-epileptic drugs.~   "
253232|NCT00236847|"~     The purpose of this study is to evaluate the effectiveness and safety of topiramate as an~     add-on therapy in patients with uncontrolled partial onset seizures who are taking one or two~     standard antiepileptic drugs.~   "
253233|NCT00236834|"~     The purpose of this study is to compare the safety and effectiveness of levofloxacin with~     imipenem/cilastatin in the treatment of hospital-acquired pneumonia~   "
253234|NCT00236821|"~     The purpose of this study is to evaluate the effectiveness and safety of two antibiotic~     regimens in the treatment of community-acquired pneumonia in non-hospitalized adult patients.~     A 5-day course of 750 milligrams of levofloxacin given once daily will be compared to a~     10-day course 500 milligrams of levofloxacin given once daily.~   "
253235|NCT00236808|"~     The purpose of this study is to compare the safety and effectiveness of levofloxacin to~     ciprofloxacin in patients with chronic bacterial prostatitis.~   "
253236|NCT00236795|"~     The purpose of the study was to compare the contraceptive efficacy and safety of the~     transdermal patch to Triphasil.~   "
253237|NCT00236782|"~     The purpose of the study was to compare the contraceptive efficacy and safety of the~     transdermal patch to Mercilon.~   "
253243|NCT00236704|"~     The purpose of this study is to evaluate the effectiveness and safety of topiramate as an~     add-on therapy in epilepsy patients with uncontrolled primary generalized tonic-clonic~     seizures, who are taking 1 or 2 standard antiepileptic drugs.~   "
253244|NCT00236691|"~     The purpose of this study is to evaluate the efficacy and safety of topiramate as add-on~     therapy in patients with difficult to control partial onset seizures who are taking one or~     two standard antiepileptic drugs.~   "
253245|NCT00236678|"~     The purpose of this research study is to determine fatigue (tiredness) in subjects with~     chronic Rheumatoid Arthritis with chronic anemia. Fatigue in subjects who get PROCRIT will be~     compared to fatigue in subjects who get placebo (a medically inactive substance). The study~     will also evaluate hemoglobin levels (oxygen-carrying protein in red blood cells), safety,~     anemia related health concerns, vitality, arthritis related function and work productivity.~   "
253246|NCT00236665|"~     The purpose of this study is to compare the efficacy and safety of daily topiramate (96mg or~     192mg) versus placebo in obese patients with mild to moderate high blood pressure.~   "
253247|NCT00236652|"~     The purpose of this study is to evaluate the effectiveness and safety of a once-daily~     administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating~     bacterial sinus infections.~   "
253248|NCT00236639|"~     The purpose of this study is to compare the efficacy and safety of topiramate (96, 192, and~     256mg daily) with placebo in long-term treatment of obesity.~   "
253249|NCT00236626|"~     The purpose of this study is to investigate (1) the effect of topiramate on insulin~     sensitivity in overweight or obese patients with type 2 diabetes mellitus and (2) the safety~     of topiramate in type 2 diabetic patients. The study will also investigate the effect of~     topiramate on body weight, body fat, fat distribution, and metabolic control including both~     glucose and lipid levels.~   "
253250|NCT00236613|"~     The purpose of this study is to compare the safety and effectiveness of topiramate (64mg,~     96mg, 192mg, and 384mg daily) with placebo in the treatment of obesity.~   "
253251|NCT00236600|"~     The purpose of this study is to compare the efficacy and safety of topiramate 96mg and 192mg~     daily) with placebo in the treatment of obesity following an intensive non-pharmacologic~     weight loss program.~   "
253252|NCT00236587|"~     The purpose of this study is to document the long term safety of a long-acting injectable~     formulation of risperidone in the treatment of patients with schizophrenia who have~     previously been treated with long-acting risperidone. Efficacy will also be evaluated.~   "
253253|NCT00236574|"~     The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in~     patients with mild cognitive impairment.~   "
253254|NCT00236561|"~     The purpose of this study is to evaluate the safety and efficacy of two doses of topiramate~     (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The~     study will also assess dose response relationship of topiramate, estimate the relative~     efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect~     of migraine prevention with topiramate versus placebo on Health Related Quality of Life.~   "
253255|NCT00236548|"~     The purpose of this study is to assess the usefulness of the RisperdalÂ® ConstaÂ® Treatment~     Guidebook in helping the doctor switch the adult patient from taking risperidone tablets~     daily by mouth to taking long-acting risperidone by injection. The study will also evaluate~     the effectiveness and safety of long-acting risperidone and its effect on patient~     satisfaction.~   "
253256|NCT00236535|"~     The purpose of this study is to explore the pain-relieving effects and safety of two~     analgesic treatment regimens as compared to placebo in patients experiencing acute~     musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal~     pain from an ankle sprain severe enough to require prescription pain relief medication will~     be randomized to receive either tramadol HCl/acetaminophen, hydrocodone~     bitartrate/acetaminophen or placebo.~   "
253257|NCT00236522|"~     The purpose of this study is to evaluate the effectiveness and safety of two antibiotic~     regimens in the treatment of acute bacterial sinusitis (sinus infection) in non-hospitalized~     adult patients. A 5-day course of 750 milligrams of levofloxacin given by mouth once daily~     will be compared to a 10-day course of 500 milligrams of levofloxacin given by mouth once~     daily.~   "
253258|NCT00236509|"~     The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate~     (50 milligrams[mg], 100mg, and 200mg taken daily) compared with placebo in the prevention of~     migraine.~   "
253259|NCT00236496|"~     The purpose of this study is to assess the safety and effectiveness of topiramate as compared~     to placebo in treating patients with tremor of unknown cause.~   "
253260|NCT00236483|"~     The purpose of this study is to explore the pain-relieving effects and safety of two~     analgesic treatment regimens as compared to placebo in patients experiencing pain after oral~     surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study~     will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared~     with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment~     of pain following oral surgery.~   "
253261|NCT00236470|"~     The primary purpose of this study is to document the long-term safety of an oral formulation~     of risperidone in the treatment of children and adolescents with conduct and other disruptive~     behavior disorders. Data on the efficacy of the drug will also be collected. Only patients~     who were enrolled in the previous related study would be eligible to participate.~   "
253262|NCT00236457|"~     The purpose of this study is to document both short-term, as well as long-term efficacy and~     safety of a long-acting injectable formulation of risperidone, in comparison with olanzapine~     for the treatment of patients with schizophrenia or schizoaffective disorder.~   "
253263|NCT00236444|"~     The purpose of this study is to assess the efficacy and safety of risperidone as maintenance~     therapy to prevent symptoms of relapse in children and adolescents with conduct and other~     disruptive behavior disorders, who initially responded well to treatment.~   "
253264|NCT00236431|"~     The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in~     patients with mild cognitive impairment.~   "
253265|NCT00236418|"~     The purpose of this study is to evaluate the efficacy and safety of topiramate as an add-on~     therapy in epilepsy patients with uncontrolled primary generalized tonic-clonic seizures, who~     are taking 1 or 2 standard antiepileptic drugs.~   "
253266|NCT00236405|"~     The purpose of this study is to compare the effect of perioperative administration of PROCRIT~     to that of autologous blood donation on post-operative rehabilitation outcomes in patients~     undergoing unilateral knee surgery.~   "
253267|NCT00236392|"~     The purpose of this study is to assess the efficacy and safety of long-term, on-demand~     maintenance therapy with rabeprazole in patients with non-erosive reflux disease (NERD).~   "
253268|NCT00236379|"~     The purpose of this study is to assess and compare how risperidone and olanzapine, two~     antipsychotic medications, affect the regulation of glucose (sugar) in the body.~   "
253269|NCT00236366|"~     The purpose of the study is to determine if fentanyl, delivered through the skin via an~     adhesive patch, has a superior pain-relieving effect compared with placebo in patients with~     osteoarthritis pain that is inadequately controlled by therapeutic treatment with weak~     opioids, which are often taken in combination with non-opioid analgesics.~   "
253270|NCT00236353|"~     The purpose of this study is to assess the effectiveness and safety of long-acting~     risperidone given as a once monthly injection to adult patients with schizophrenia or~     schizoaffective disorder.~   "
253271|NCT00236340|"~     To compare the efficiency and maternal and fetal tolerance of two techniques of~     amnioreduction used in cases of symptomatic second and third trimester polyhydramnios:~     syringe manual aspiration technique (S group) and continuous suction technique (C group) set~     to – 250 mmHg~   "
253272|NCT00236327|"~     The purpose of this study is to determine the safety and efficacy of pain control by~     fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour~     in 80 out-patients with intense chronic cancer pain. Higher doses are allowed by permission~     of the investigator and rescue oral morphine medication is allowed.~   "
253273|NCT00236301|"~     Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone~     replacement therapy on inflammatory markers are dose-dependent.~   "
253274|NCT00236288|"~     To test the feasibility of an intensive behavioral and pharmacologic tobacco cessation~     program for radiation oncology patients and their families/companions.~   "
253275|NCT00236275|"~     Predict and follow thanks to imaging the response to neoadjuvant chemotherapy in locally~     advanced breast carcinoma. Hypothesis : FLT-(18F)PET will be a predictor superior to both~     FDG-(18F) PET and MRI~   "
253276|NCT00236262|"~     The objective of this study is to analyze by trans-oesophageal echocardiography the effect on~     the right ventricle of positive expiratory pressure (PEP) level variations with constant~     plate pressure among patients with syndrome of acute respiratory distress of the adult~     (SDRA). The assumption tested is that a high level of PEP increases the impedance with the~     ejection of the right ventricle independently of the level of plate pressure. The effect on~     the right ventricular preload will be checked via the analysis of the respiratory variability~     of the diameter of the higher vena cava.~   "
253277|NCT00236249|"~     The purpose of this study is to check if lidocaine intravenous administration during surgery~     and 24 hours after surgery, associated with standardised management of the patient, helps to~     accelerate recovery and to improve the quality of recovery, after surgery for colic or rectal~     neoplasms.~   "
253278|NCT00236236|"~     The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization~     therapy in patients with heart failure.~   "
253279|NCT00236223|"~     Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e.~     morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These~     side-effects are unpleasant for the patients and sometimes keeps them at bed longer time than~     needed. We investigate in new combinations of analgesics for postoperative pain, hoping to~     minimize the need for morphine.~   "
253280|NCT00236210|"~     VIP is a demonstration project with a goal to decrease modifiable risk factors for those with~     a higher risk of having a vascular event such as a heart attack or stroke or of developing~     vascular disease. Introduced as a study, VIP compares whether there is a significant~     reduction of modifiable vascular risk factors among patients who are involved in a~     personalized directed program versus those being provided standard care by their physician.~     Health care providers work collaboratively with the 'VIP Team' to improve the participants'~     vascular health.~   "
253281|NCT00236197|"~     The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in~     treating frequent heartburn.~   "
253282|NCT00236184|"~     The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10~     mg in treating frequent heartburn.~   "
253283|NCT00236171|"~     The purpose of this study is to evaluate the efficacy of the topical therapies Protopic and~     Advantan as well as their combination against placebo in a Psoriasis Plaque Test~   "
253284|NCT00236158|"~     Hypothesis Treatment with rate adaptive single chamber atrial pacing (AAIR) reduces the risk~     of death compared with rate adaptive dual chamber pacing (DDDR) in patients with sick sinus~     syndrome (SSS).~      Primary purpose The primary purpose of this randomised trial is to compare AAIR and DDDR~     pacing in patients with SSS and normal atrioventricular (AV) conduction with respect to the~     primary end point overall mortality.~   "
253285|NCT00236145|"~     The primary objective of the study is to determine whether a test titration regimen of ACTIQ~     treatment will reduce the number of inadequately managed episodes of breakthrough pain for an~     individual patient by attaining a successful dose of ACTIQ treatment more quickly. The~     successful ACTIQ dose provides a satisfactory combination of efficacy and tolerability after~     a single administration, as assessed by the patient.~   "
253286|NCT00236132|"~     The main goal of the pectus multicenter outcomes study is to document the utility of PEx~     repair in improving health and quality of life and to test the prevailing belief that the two~     predominant surgical procedures currently in use for PEx repair are essentially equivalent in~     terms of long-term outcomes.~      We believe the uncertainty about the impact of PEx on cardiopulmonary function is due to part~     to the fact that the previous studies have not measured the physiological parameters mostly~     likely affected by the defect. A protocol to test this was developed. Thus, we propose to use~     these measures as well as conventional output of progressive exercise test to examine~     cardiopulmonary function before and after surgical repair of PEx within the context of the~     original study.~   "
253287|NCT00236119|"~     A 12-Week, Exploratory, Open-Label, Nonrandomized, Dose-Escalation Study of the Efficacy,~     Safety and Tolerability of Oral CEP-701 in Patients with Severe, Recalcitrant, Plaque Type~     Psoriasis.~   "
253288|NCT00236106|"~     Main objective:to assess short term growth in children with atopic dermatitis during~     treatment with tacrolimus 0.1% and mometasone furoate 0.1%. A singl blind randomised cross~     over trial including 20 children. The study consists of 5 periods: run in, treatment(1),wash~     out, treatment(2) and run out. Each period 14 days where the children will use tacrolimus~     ointment tvice daily, mometasone furoate once daily or moisturizer (in run in wash out and~     run out)~   "
253289|NCT00236093|"~     The objective of the study is to monitor the safety (adverse event data) of longer-term use~     of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) treatment in children with pain~     associated with cancer, sickle cell disease, or severe burns and breakthrough pain (BTP) who~     are receiving around the clock (ATC) opioid therapy.~   "
253290|NCT00236080|"~     The purpose of the study is to compare the overnight efficacy and plasma concentration-time~     profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive~     sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).~   "
253291|NCT00236067|"~     The purpose of this study is to evaluate the safety and efficacy of an investigational~     anti-anxiety medication relative to placebo in patients with generalized anxiety disorder~     (GAD).~   "
253292|NCT00236054|"~     The purpose of this study is to evaluate the safety and efficacy of an investigational~     anti-anxiety medication relative to placebo in patients with generalized anxiety disorder~     (GAD)~   "
253293|NCT00236041|"~     The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the~     management of breakthrough pain (BTP) compared to placebo treatment in children with cancer~     and non-cancer pain who are receiving around-the-clock (ATC) opioid therapy and who require~     additional therapy for BTP episodes. This will be determined by the analysis of the pain~     intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes~     after the start of each unit of study drug with an optimal ACTIQ dosage.~   "
253294|NCT00236028|"~     The purpose of this study is to evaluate the efficacy and safety of infliximab (Remicade) in~     patients with early rheumatoid arthritis.~   "
253295|NCT00236015|"~     The purpose of this study is to evaluate the safety and efficacy of an investigational~     anti-anxiety medication relative to placebo in patients with generalized anxiety disorder~     (GAD).~   "
253296|NCT00236002|"~     Multi-center,double blind randomized phase III placebo controlled study in 250 men with~     histologically proven prostate cancer with out bone metastases who are beginning ADT therapy~     and who will receive concomitant treatment with either oral Fosamax 70mg once weekly or~     placebo for one year.These men will be treated and follow up for one year,during which time~     changes in BMD, markers of bone resorption and formation will be monitored.All patients will~     receive calcium and vitamin D through out the study.~   "
253297|NCT00235989|"~     The purpose of this study is to determine if a higher dose of study drug is more effective in~     preventing relapses in patients with Multiple Sclerosis.~   "
253298|NCT00235976|"~     This is a multicenter, randomized, controlled, observer-blinded, dose-response study to~     evaluate the efficacy in tracheal intubation and safety of gantacurium chloride for injection~     in healthy adult patients undergoing surgery with general anesthesia.~      Gantacurium chloride for injection (previously referred to as AV430A) is a new,~     investigational non-depolarizing ultra-short acting neuromuscular blocking agent (NMB).~     Preliminary results in animals and healthy human subjects (Phase 1 studies in adult~     volunteers) suggest that gantacurium chloride for injection may provide a useful adjunct to~     general anesthesia by permitting rapid intubation. This Phase 2 study will provide more~     definitive information on the ultra-short acting profile of the compound by determining the~     quality of intubation in patients, at 60 seconds, as assessed by a blinded intubator. In~     addition, the safety of the compound will be assessed. In this study, the efficacy and safety~     of gantacurium chloride for injection will also be compared to a reference drug,~     succinylcholine, and to placebo.~      The primary objective of this study is to determine the dose-response relationship of~     gantacurium chloride for injection on tracheal intubation conditions after a single rapid~     bolus intravenous (i.v.) dose as a component of a propofol/opioid induction-intubation~     sequence and to assess the safety profile of this compound.~   "
253299|NCT00235963|"~     To determine whether HMG-CoA reductase inhibitor simvastatin prevents or ameliorates~     subarachnoid hemorrhage-induced delayed vasospasm and its ischemic consequences.~   "
253300|NCT00235950|"~     The purpose of this study is to compare the efficacy between two lipid lowering treatments,~     rosuvastatin (10-40 mg) and atorvastatin (20-80 mg) in reducing low-density lipoprotein~     cholesterol (LDL-C) levels after 16 weeks of treatment in patients with coronary heart~     disease~   "
253301|NCT00235937|"~     The purpose of this study is to determine the efficacy and tolerance of the association of~     two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and~     Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.~   "
253302|NCT00235924|"~     The main objective of this study is to determine the effects on the endometrium and breast of~     70 mg daily dose of isoflavones.~   "
253303|NCT00235911|"~     The primary objective is to compare the effects of Symbicort SiT and treatment according to~     NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20~     histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).~   "
253304|NCT00235898|"~     The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil~     (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer.~   "
253305|NCT00235885|"~     The purpose of the study is to assess the safety and clinical efficacy of adalimumab in~     active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard~     therapy including patients that have failed other TNF therapies~   "
253306|NCT00235872|"~     The purpose of the study is to assess the long-term safety and tolerability of repeated~     administration of adalimumab in Japanese subjects with rheumatoid arthritis.~   "
253307|NCT00235859|"~     The purpose of the study is to assess the safety and efficacy of adalimumab compared to~     placebo in subjects with rheumatoid arthritis on methotrexate therapy.~   "
253332|NCT00235495|"~     The goal of the trial is to determine whether human albumin, administered within 5 hours of~     symptom onset, improves the 3-month outcome of subjects with acute ischemic stroke.~   "
253308|NCT00235846|"~     Conventional open vein harvesting from the legs during coronary artery bypass surgery result~     in wound complications among 30% of the patients. Endoscopic harvesting decrease the~     complication rate, but it remains to be shown whether this is also a fact among patient in~     whom only short segments of veingraft material is needed from the leg. We hypothesise that~     the rate of wound complications will be reduced and the patient satisfaction will be~     increased also among patients in whom only short vein segments are endoscopically harvested~     compared to conventional open vein harvesting.~   "
253309|NCT00235833|"~     The purpose of the study is to assess the long-term safety, tolerability, and efficacy of~     repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.~   "
253310|NCT00235820|"~     Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and~     Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis~   "
253311|NCT00235807|"~     The purpose of this multi-site randomized clinical study was to assess treatment outcomes for~     three forms of tinnitus treatment: Tinnitus Retraining Therapy (TRT), Tinnitus Masking, and~     Tinnitus Education (TED). There were four study sites: VAMC Audiology Clinics at Bay Pines,~     FL; Portland, OR; Seattle, WA; and San Diego, CA. Thirty-six subjects (Veterans) were~     enrolled into treatment at each site - 12 into each treatment group. Each subject received 18~     months of treatment. Treatment appointments and outcome questionnaires occurred at 0, 3, 6,~     12, and 18 months. Qualified subjects were initially randomized to one of the treatment~     groups or to a 6-month Waiting List group. Those in the Waiting List group completed outcome~     questionnaires at 3 and 6 months, and were randomized into one of the three treatment groups.~     They then received 18 months of treatment as above.~   "
253312|NCT00235794|"~     Open-label exloratory pharmacodynamic and pharmacogenomic study to evaluate teh biologic~     effects of 3 dose levels (1mg, 5 mg, and 15 mg) of temsirolimus administered orally once~     daily for approximately 4 weeks (+/- 2 weeks) before prostatectomy~   "
253313|NCT00235781|"~     The aim of this trial is to compare the safety and efficacy of a single dose of~     Thymoglobulin, rabbit derived antithymocyte globulin (Thymoglobulin, SangStat, Fremont, CA)~     to our standard four dose, four day Thymoglobulin induction regimen from the time of~     transplantation through a six month follow-up period. The primary endpoint will be the~     incidence of acute rejection. Secondary endpoints will include serious adverse events,~     evaluation of renal function, patient and graft survival, incidence of infectious~     complications, incidence of post-transplantation lymphoproliferative disorder (PTLD),~     duration and extent of lymphocyte depletion and immunoassays for evidence of recipient immune~     response to the allograft as well as duration of hospital stay.~   "
253314|NCT00235768|"~     The purpose of this study is to investigate the possible neurotoxic effects of the party-drug~     Ecstasy (MDMA)on brain and brain function in humans. Main research questions concern the~     causality, course and clinical relevance of the neurotoxicity of ecstasy~   "
253315|NCT00235755|"~     This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed~     at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in~     patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).~   "
253316|NCT00235729|"~     The main objective of this study is to investigate the effectiveness of lofexidine in~     reducing withdrawal symptoms among subjects undergoing opiate detoxification. Currently,~     lofexidine is the most commonly used non-opiate medication for detoxification from opiates in~     the United Kingdom (UK). There is no non-opiate medication approved by the Food and Drug~     Administration (FDA) for the same indication in the United States (US). The only medications~     currently approved by the FDA for opiate detoxification are methadone and buprenorphine.~     These medications, however, have the potential to be abused. Lofexidine, on the other hand,~     offers a unique advantage for opiate detoxification because it is not addicting, is easy to~     use, and has a favorable safety profile.~   "
253317|NCT00235716|"~     The purpose of this study is to determine whether alpha-tocopherol, memantine (Namenda), or~     the combination will significantly delay clinical progression in mild to moderately demented~     patients with Alzheimer's disease compared to placebo.~   "
253318|NCT00235703|"~     This is a four-year study, funded by the Center for Disease Control and Prevention, related~     to antimicrobial resistance in rural communities. The project consists of four components: A)~     surveillance of antimicrobial resistance, B) promotion of appropriate antimicrobial drug~     prescribing, C) preliminary assessment of the environmental impact of antimicrobials, and D)~     the development of new antimicrobial products. Six rural communities in Utah, and six rural~     communities in Idaho are participating in this study. Component D is being performed by~     investigators at Harvard University, under the direction of Co-Investigator Roger Inouye.~   "
253319|NCT00235690|"~     More than 80 patients at the University of Pittsburgh Medical Center have been infected with~     Pseudomonas aeruginosa, lacking susceptibility to all commercially available antibiotics~     except colistin. This antibiotic was developed in the 1960s and preliminary pharmacokinetic~     studies were performed at that time. Dosing recommendations, on the basis of these~     pharmacokinetic studies, are listed in the drug's product information. However, there are no~     dosing recommendations for patients requiring renal replacement therapy (either intermittent~     hemodialysis or continuous venovenous hemofiltration). Furthermore, the science of antibiotic~     dosing (pharmacodynamics) has changed significantly since the 1960s and it is quite~     possible that the dosing recommendations listed in the product information are not optimal.~     Furthermore, even though physicians refer to colistin administration, the only intravenous~     form of the drug is colistin methanesulfonate (CMS). CMS is converted in the body to~     colistin. Both CMS and colistin have different pharmacokinetic and antimicrobial activities.~     For this reason, we, the investigators at the University of Pittsburgh, are performing a~     pilot study of the pharmacokinetics of intravenous CMS/colistin in patients requiring this~     antibiotic for clinical purposes. Plasma concentrations will be determined around a~     CMS/colistin dose once the drug has reached steady state. Concentrations in pulmonary~     epithelial lining fluid will also be determined in patients with pneumonia. Microbiologic and~     clinical endpoints will be determined and will be correlated with these concentrations. The~     measurement of CMS and colistin levels will be determined by a laboratory in Australia which~     developed these assays. A submission is being made to the National Institutes of Health (NIH)~     for funding of a multicenter study which will address this research question with a greater~     sample size. The study proposed here is a pilot study in order to prove the feasibility of~     the research approach and to provide preliminary data for the NIH proposal.~   "
253320|NCT00235677|"~     Aim:~      To evaluate the therapeutic efficacy of a therapeutic procedure, involving endoscopic~     suturing, for gastroesophageal reflux disease (GERD) compared to a sham procedure.~      The hypotheses tested in this study were that active treatment would: 1) decrease the use of~     antisecretory medication, 2) decrease GERD symptoms, 3) improve quality of life, and 4)~     reduce esophageal acid exposure.~   "
253333|NCT00235482|"~     The purpose of this study is to determine the safety of an injection of coxsackievirus A21~     into a melanoma tumour, and also to see if there is a tumour response.~   "
253321|NCT00235664|"~     Infections caused by multidrug resistant bacteria have become more prevalent at many tertiary~     care and academic centers. These infections are associated with increased morbidity and~     mortality. The initial empiric antibiotic choice may not be adequate and delay in initiating~     appropriate therapy is a reason for poorer outcomes. Furthermore, not uncommonly the only~     therapeutic options available are associated with significant toxicity. This is a particular~     challenge for solid organ transplant recipients, who are immunosuppressed and have a higher~     risk of acquiring infections. Exposure to different classes of antibiotics has been linked to~     development of antibiotic resistance. Determining the risk factors for acquisition of~     drug-resistant bacteria and the molecular mechanisms by which resistance occurs would allow~     the development and implementation of strategies to minimize these infections and therefore~     improve outcomes. We, the researchers at the University of Pittsburgh, aim to collect~     surveillance cultures on patients undergoing liver, intestinal and multivisceral~     transplantation in order to determine the prevalence and risk factors for Pseudomonas~     aeruginosa (P. aeruginosa), extended-spectrum β-lactamases (ESBL)-Klebsiella and~     methicillin-resistant Staphylococcus aureus (MRSA), as well as determine the molecular~     mechanisms associated with the development of resistance in P. aeruginosa.~   "
253322|NCT00235651|"~     The purpose of this study is to quantify the dose of aerosol medication deposited in the~     lungs of lung transplant recipients receiving a single nebulized treatment of aerosolized~     Abelcet® (lipid complexed amphotericin-B). This study is being performed to determine the~     range of deposited doses and patterns of distribution that could be expected in this~     population so that the ultimate efficacy of this preparation can be evaluated. A radioisotope~     technique will be utilized to track the medication dose. The study will include 12 subjects~     who will perform one testing session lasting approximately 3 hours. An Investigational New~     Drug Application (IND) detailing this protocol has been submitted by the principal~     investigator (PI) and approved by the Food and Drug Administration [FDA] (72,521).~   "
253323|NCT00235625|"~     Turmeric (Curcuma Longa) is member of the ginger family and is best known for its culinary~     use as the major of component of curry powder. The volatile of oils (called curcuminoids) of~     the turmeric root, however, have anti-inflammatory actions which make them promising~     candidates for the treatment of psoriasis. For example, curcumin has been shown to improve~     psoriasis in experiments using in vitro models. Turmeric has been shown to have minimal side~     effects in doses up to 12 grams per day. The purpose of this study is to determine the safety~     and to estimate the efficacy of oral Curcuminoid C3 Complex® in patients with chronic~     psoriasis vulgaris.~   "
253324|NCT00235599|"~     This project is designed to answer the question: Is there an acute IGFBP-3 response in normal~     children?~      Our specific hypothesis states that under the influence of growth hormone secretagogues,~     intact IGFBP-3 molecule will undergo proteolysis and liberate IGFBP-3 fragments, along with~     other components of the ternary complex. This proteolysis will result in measurable rise in~     IGFBP-3, which will indicate the subject’s growth hormone status. Short children with growth~     hormone deficiency will not show an IGFBP-3 response.~   "
253325|NCT00235586|"~     To learn if there is a connection between low vitamin D level and hardening of the arteries.~   "
253326|NCT00235573|"~     Vitamin B12 is an essential nutrient that the body needs for cells to divide and function~     normally. Individuals may develop a deficiency of vitamin B12 by either limiting the amount~     in the diet or by decreased vitamin B12 intake into the body (absorption). Keeping adequate~     B12 blood levels is important for health. Vitamin B12 deficiency may increase one's risk for~     developing anemia and can even lead to neurological problems and paralysis if the deficiency~     is severe and lasts a long time. It is very important for doctors to have accurate tests to~     determine if people are absorbing vitamin B12 normally so that treatment can be started~     before severe clinical problems occur.~      The purpose of this research is to provide new information that may help scientists develop a~     better method to test for problems with absorbing vitamin B12. In this study, changes in the~     amounts of vitamin B12 bound to protein (transcobalamin) in the blood will be measured after~     doses of vitamin B12 are taken. If the amounts of this vitamin B12-protein complex (called~     holo-transcobalamin) change in response to taking a vitamin B12 supplement in normal~     individuals, it may be possible to use this information to develop a new sensitive test to~     identify individuals who have problems absorbing vitamin B12. This new vitamin B12 absorption~     test may be a better clinical test for vitamin B12 absorption than those now available for~     doctors to use.~   "
253327|NCT00235560|"~     These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in~     combination with low-dose aracytin in elderly AML.~   "
253328|NCT00235547|"~     This is a randomized, controlled trial investigating whether immediate versus standard,~     Sunday Start, initiation of transdermal hormonal contraception (the patch) in post-abortion~     subjects can improve compliance and the continuation of contraception. Immediate initiation~     of the patch has been studied in women seeking contraception when they are not immediately~     post-abortion, and this Quick Start method has been shown to improve the continuation of~     the patch into a second month. The primary hypothesis of this study is that immediate~     initiation of the patch in post-abortal women will improve the continuation of contraception~     over delayed initiation on the first Sunday after an abortion.~   "
253329|NCT00235534|"~     This is a randomized, controlled trial investigating whether immediate versus standard,~     Sunday Start, initiation of oral contraceptive pills (OCPs) in post-abortion subjects can~     improve compliance and the continuation of contraception. Immediate initiation of OCPs has~     been studied in women seeking contraception when they are not immediately post-abortion, and~     this Quick Start method has been shown to improve the continuation of OCPs into a second~     pill pack. The primary hypothesis of this study is that immediate initiation of OCPs in~     post-abortal women will improve the continuation of contraception over delayed initiation on~     the first Sunday after an abortion.~   "
253330|NCT00235521|"~     Inhaled nitrous oxide (iNO) will be compared to aerosolized iloprost (ILO) in pediatric~     patients after cardiac surgery with pulmonary hypertension. The hypothesis is that iloprost~     is more effective in preventing pulmonary hypertensive crises.~   "
253331|NCT00235508|"~     To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of~     insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will~     receive an approved anxiolytic agent and will be randomized to nightly therapy with either~     eszopiclone or placebo.~   "
253334|NCT00235469|"~     This phase 2b trial is being conducted at approximately 60 sites in the US to investigate~     whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic~     neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of~     lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic~     neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity~     of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of~     treatment.~      To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a~     diary to record their daily pain intensity (morning and evening), pain interference with~     sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and~     subjects' quality of life will be investigated. In addition, safety and tolerability of the~     different doses of lacosamide will be investigated.~   "
253335|NCT00235456|"~     Supplemental perioperative oxygen has been reported to halve or double the risk of surgical~     wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk~     following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to~     30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed~     by blinded investigators using Centers for Disease Control criteria. Baseline patient~     characteristics, anesthetic management, and potential confounding factors were recorded.~     Wound infection rates were compared with chi-square analysis. Logistic regression identified~     the contribution of potential confounding factors. Surgical wound infection occurred in 24.4%~     of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P<0.039).~     According to logistic regression, the relative risk of infection in patients given~     supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection~     risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to~     patients undergoing colorectal surgery.~   "
253336|NCT00235443|"~     Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with~     lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and~     tolerability of the different doses of lacosamide will be investigated.~   "
253337|NCT00235417|"~     The purpose of this study is to determine whether intracoronary bone marrow transplantation~     can improve left ventricular ejection fraction in patients with severe ischemic heart failure~     and no other option for standard therapies (revascularization and drugs).~   "
253338|NCT00235404|"~     To study the efficacy of multicomponent treatment and care for patients with acute illness or~     deterioration of a chronic disease at a nursing home in primary health care compared to~     traditional treatment at hospital.~   "
253339|NCT00235391|"~     This is an open-label, non-randomized, multi-center trial designed to provide expanded access~     of deferasirox to patients with congenital disorders of red blood cells and chronic iron~     overload from blood transfusions who cannot adequately be treated with locally approved iron~     chelators.~   "
253340|NCT00235378|"~     The purpose of this study is to perform genetic testing in and to collect information from~     families affected by lupus in order to identify the genetic factors associated with systemic~     lupus erythematosus (SLE).~   "
253341|NCT00235365|"~     The purpose of this study is to determine the effect of meta-cognitive therapy for insomnia.~   "
253342|NCT00235352|"~     The purpose of this study is to evaluate the effects of a four-week trial of CX516 900mg tid~     compared to placebo upon verbal memory, attention and negative symptoms. The AMPA receptor~     positive modulator, CX516, will be added to a stable dose of clozapine, olanzapine or~     risperidone in inpatients and outpatients with schizophrenia. The trial is intended to extend~     and replicate results from our previous placebo-controlled pilot trial of CX516 added to~     clozapine in which the investigators found improvement in memory and attention~     (moderate-to-large between group effect sizes) and did not observe serious side effects.~     Because the investigators' pilot trial also detected at two-week follow-up persistence of~     cognitive benefits and emergence of a large therapeutic effect upon negative symptoms, this~     trial will also repeat clinical and cognitive assessments at follow-up, four weeks after~     completion of the study medication to evaluate persistence and/or strengthening of effects.~   "
253343|NCT00235339|"~     The purpose of this study is to investigate the effect of the standard rehabilitation offered~     by three hospital rehabilitation units in Norway, one in Trondheim, one in Ålesund and one in~     Levanger, compared to an interval treadmill training program. The subjects participating in~     the study are patients with myocardial infarction. The maximal oxygen consumption of the~     subjects will be tested before and after the training period.~   "
253344|NCT00235326|"~     Acute Bacterial dysentery leads to chronic symptoms of disturbed bowel habit in a minority of~     individuals. This condition known as post infectious irritable bowel syndrome (PI-IBS)~     remains poorly understood. This could allow material in the bowel to reach deeper tissues of~     the bowel wall leading to inflammation and changes in muscle and nerve function. This is also~     early evidence that genetic programming of people with PI-IBS prevents them from turning off~     inflammation once it begins. Literature suggests that IBS may develop at greater rates in~     individuals with pro-inflammatory genotype and that these individuals may be at increased~     risk of inflammatory bowel diseases (IBD).~   "
253345|NCT00235313|"~     Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However,~     their effectiveness is low. This study aims to answer the question: Does the dose adjustment~     of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve~     their efficacy compared with the lack of dose adjustment (usual care) in smoking patients~     with smoking related disease condition.~   "
253346|NCT00235300|"~     A multicenter clinical study comparing event-free survival at 6 months after transplant~     between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients~     received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of~     the transplant procedure.~      Subjects meeting all inclusion and exclusion criteria were eligible to participate in this~     study. The treatment assignment was random and not chosen by the subject or their physician.~      Subjects were monitored during treatment with Thymoglobulin and during the transplant~     hospitalization. Additional subject monitoring occurred up to 12 months after transplant.~      278 study subjects were enrolled at 28 transplant centers in the United States and Europe.~   "
253390|NCT00234728|"~     The purpose of this study is to determine if a new dressing designed to be used with topical~     medications will enhance the effects of these topical medications.~   "
253347|NCT00235287|"~     The purpose of this study is to determine whether a combination therapy with~     angiotensin-converting enzyme (ACE)-inhibitors and angiotensin receptor blockers reduces the~     arterial stiffness assessed by applantiontonometry more than a single treatment in kidney~     patients.~   "
253348|NCT00235274|"~     The overarching purpose of the proposed study is to determine Secretin's (RG1068)~     psychophysiological effects on measures of motor learning, affective, and inhibitory~     information processing in individuals with schizophrenia. Motor learning will be assessed~     with a classical eye-blink conditioning procedure, requiring the learning of a reflexive~     eye-blink response to a weak puff of air to the eye.~   "
253349|NCT00235261|"~     Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e.~     morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness,~     which is unpleasant for the patients and sometimes keeps them at bed longer time than needed.~     We investigate in new combinations of analgesics for postoperative pain, hoping to minimize~     the need for morphine and improve the patients pain score after operation.~   "
253350|NCT00235248|"~     The ARCH is a controlled trial with a sequential design and with a prospective, randomized,~     open-label, blinded-endpoint (PROBE) methodology. The objective is to compare the efficacy~     and tolerance (net benefit) of two antithrombotic strategies in patients with~     atherothrombosis of the aortic arch and a recent (less than 6 months) cerebral or peripheral~     embolic event.~      Hypothesis:~      The association of clopidogrel 75 mg/d plus aspirin 75 mg/d is 25% more effective than an~     oral anticoagulant (target International Normalized Ratio [INR] 2 to 3) in preventing brain~     infarction, brain hemorrhage, myocardial infarction, peripheral embolism, and vascular death.~   "
253351|NCT00235235|"~     The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and~     pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for~     advanced breast cancer. To date no other trial has analyzed gene and protein expression at~     the same time points in the same patient, combined with clinical outcome. Similar to previous~     attempts to predict response based on expression of a single gene or protein, the researchers~     expect that neither genomic or proteomic profiling alone will be sufficient to optimize~     therapy. Rather, the researchers expect an iterative process that combines information~     gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.~   "
253352|NCT00235222|"~     Lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to~     stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced~     doses of stavudine (30 mg b.i.d.) in HIV patients with controlled viral load and body weight~     > 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b.i.d.~   "
253353|NCT00235209|"~     This is a randomized (1:1), prospective, open label, multicenter, comparative study to be~     examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on~     venous leg ulcers.~   "
253354|NCT00235196|"~     This is a randomized (1:1), prospective, open label, multicenter, comparative study to be~     examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on~     diabetic foot ulcers.~   "
253355|NCT00235183|"~     The aim of the study is to compare the clinical efficacy of three types of plasma secured on~     the viral level either by quarantine or by chemical treatment in patients undergoing liver~     transplantation.~   "
253356|NCT00235170|"~     The main objective is to compare the effectiveness of coronary stent implantation using the~     sirolimus-eluting Bx VELOCITY™ balloon expandable stent with that of surgery as observed in~     ARTS I. Effectiveness is measured in terms of Major Cardiac and Cerebrovascular Events~     (MACCE) free survival at 1 year.~   "
253357|NCT00235157|"~     The primary objective of this study is to compare the safety and performance of the Palmaz~     Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of~     renal artery stenosis, measured at 6 months follow up via angiography.~   "
253358|NCT00235144|"~     The main objective of this study is to assess the safety and effectiveness of the~     sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native~     coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent.~     Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.~   "
253359|NCT00235131|"~     This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent~     System for the treatment of TASC C & D superficial femoral artery long lesions (up to 22 cm)~     in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency~     rate at 6 and 12 months post procedure.~   "
253360|NCT00235118|"~     The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral~     AAA device and its Delivery System compared to open surgical repair for the treatment of~     Abdominal Aortic Aneurysm (AAA).~   "
253361|NCT00235105|"~     Reduction of signs and symptoms in patients with moderate to severely early axial~     spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to~     or do not tolerate NSAID therapy.~      Study Objectives:Efficacy –To assess whether patients with moderate to severely active early~     axial spondyloarthritis (without radiological sacroiliitis) will show response when~     adalimumab is added to the pre-existing or in case of intolerance to NSAID therapy. Response~     will be measured at week 12 by change of efficacy parameters compared to baseline.Safety – To~     demonstrate the safety of adalimumab in study patients with moderate to severely active early~     axial spondyloarthritis (without radiological sacroiliitis) in patients who have had an~     inadequate response to or do not tolerate NSAID therapy.~   "
253362|NCT00235092|"~     The main objective of this study is to compare the performance of the Cypher~     sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective,~     multi-center, randomized clinical study.~   "
253363|NCT00235079|"~     The purpose of the study is to determine whether colchicine is safe and effective in~     treatment and prevention of recurrent pericarditis after failure of conventional treatment.~   "
253364|NCT00235066|"~     The main objective of this study is to assess the effectiveness of the CYPHER™~     (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary~     artery lesions in small vessels (2.25 - 2.75 mm) as compared to the small vessel tercile of~     the uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial, using a stenting technique~     that minimizes balloon trauma to the vessel and assures full coverage of the lesion with the~     stent.~   "
253365|NCT00235053|"~     This Pilot study is designed to explore the rate of local side effects of fluticasone as~     delivered by Advair and to determine the best outcome measure to assess these effects. This~     study is the initial step, and will be followed by a larger scale study.~   "
253366|NCT00235040|"~     To evaluate the effectiveness of the Acute Respiratory Infection Smart Form~   "
253367|NCT00235027|"~     Patient safety is at the forefront of critical issues in health care. Medications are the~     single most frequent cause of adverse events, and in the inpatient setting adverse drug~     events (ADEs) are common, expensive, injurious to patients, and often preventable. Relatively~     little, however, is known about the frequency of ADEs in the ambulatory setting, how to~     monitor for outpatient ADEs, or on the impact of prevention strategies such as~     computerization of prescribing supplemented by decision-support.~   "
253368|NCT00235014|"~     The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel~     blockade, a combination of these, and placebo, in the prevention of micro- and~     macro-albuminuria in Type 2 diabetic patients.~   "
253369|NCT00235001|"~     This study will investigate antihypertensive activity and safety profile of Tarka in Russian~     hypertension patients by ambulatory blood pressure measurement (ABPM)~   "
253370|NCT00234988|"~     The purpose of the study is to determine the safety and weight loss when sibutramine is used~     in overweight and obese subjects.~   "
253371|NCT00234975|"~     The purpose of this study is to evaluate clinical response and safety of a Kaletra containing~     antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.~   "
253372|NCT00234962|"~     The purpose of this study is to evaluate the effects of adherence on HIV antiviral response~     to treatment regimens containing Kaletra or other HIV protease inhibitors.~   "
253373|NCT00234949|"~     The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of~     cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.~   "
253374|NCT00234936|"~     The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate~     to improve the quality of life in patients with active RA.~   "
253375|NCT00234923|"~     The purpose of this pilot study is to obtain a preliminary assessment of the antiviral~     activity and tolerability of Kaletra single agent therapy as initial treatment for HIV~     infection, relative to a Kaletra three drug standard of care reference arm~   "
253376|NCT00234910|"~     The purpose of this study is to obtain a preliminary assessment of the antiviral activity and~     tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection,~     relative to a Kaletra three drug standard of care reference arm.~   "
253377|NCT00234897|"~     The purpose of the study is to assess the efficacy of adalimumab in subjects with rheumatoid~     arthritis focusing on subject-reported outcomes and early response to treatment~   "
253378|NCT00234884|"~     The purpose of this observational study was to observe and assess the long term use, safety,~     and effectiveness of adalimumab in a normal clinical setting.~   "
253379|NCT00234871|"~     The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is~     superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive~     subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy~   "
253380|NCT00234858|"~     The primary objective of this study is to determine whether impaired glucose tolerance is~     improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome~   "
253381|NCT00234845|"~     The purpose of the study is to evaluate the effectiveness of adalimumab in combination with~     methotrexate compared to methotrexate alone on work disability in subjects with early~     rheumatoid arthritis~   "
253382|NCT00234832|"~     The purpose of the study was to determine the long-term effect of sibutramine treatment on~     cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.~   "
253383|NCT00234819|"~     The purpose of this study is to determine whether bazedoxifene/conjugated estrogens~     combinations are effective in the treatment of moderate to severe vasomotor symptoms~     associated with menopause.~   "
253384|NCT00234806|"~     This study aims to take the existing model from the pilot of Telemedicine in Daycare and~     expand it to other suburban childcare centers and both urban and suburban elementary schools.~      An assessment of the value of telehealth in the child programs will then be initiated to~     detail the impact of utilization and costs.~      An assessment of the value of integrating telehealth into primary care practice will also be~     evaluated. The impact of continuity of care, well child visit rates, and immunization status~     will be among the various measures used in this evaluation.~   "
253385|NCT00234793|"~     The purpose of this study is to help mothers of children with cancer to cope more effectively~     by increasing their problem-solving skills.~   "
253386|NCT00234780|"~     To assess the hypothesis that In Home Hospital Care (IHHC) is as safe and effective, less~     burdensome to families, and less expensive for care of common acute pediatric problems now~     managed with hospitalization.~   "
253387|NCT00234767|"~     Study of the long term outcomes and economic impact of the pulmonary artery catheter in acute~     respiratory distress syndrome (ARDS/ALI) patients.~   "
253388|NCT00234754|"~     Stress urinary incontinence (SUI) is a health concern for many women. The transvaginal tape~     (TVT) surgery has become a common procedure to address the problem. Another surgery is now~     available, trans-obturator tape (TOT). The investigators will compare these 2 approaches to~     dealing with SUI and follow the women for 1 year. Women will also be followed at 5 years~     after surgery.~   "
253389|NCT00234741|"~     STA-5326 is an oral experimental drug that has been shown to block the release of~     interleukin-12 from peripheral blood mononuclear cells. Given this activity on the immune~     system, STA-5326 mesylate is a potential treatment for various autoimmune diseases, such as~     Crohn's disease, that are mediated by the inappropriate expression of Th1 cytokines.~      This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe,~     active Crohn's disease. Study visits include a screening visit, 4 treatment period visits~     over 4 weeks and a follow-up visit that will occur 7 days following the end of treatment.~     Subjects may continue treatment for an additional 4 weeks of open label STA-5326 mesylate~     administration that includes an additional 2 treatment period visits. Subjects will undergo a~     colonoscopy with biopsy collection at baseline, at the end of the 4 week blinded phase and at~     the end of the 4 week open label phase.~   "
253391|NCT00234715|"~     The proposed pilot study is part of the design and development process of a final~     questionnaire that aims to gain insight on factors that influences acceptance and adoption of~     breast cancer risk assessment in women. Feedback on the questionnaire will help identify~     potential issues of clarity, comprehensibility, and reliability; and to identify possible~     biases that often accompany a designed questionnaire. Information gained from the large-scale~     study will provide directions for the development of educational strategies in the TIBS~     research program that could accompany increases in public awareness of risk factors, the~     availability of risk assessment tools and preventive lifestyle.~   "
253392|NCT00234702|"~     Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate.~     The body's attempt to adjust to an increased level of phosphate in the blood can result in~     elevated levels of hormones and minerals resulting in serious clinical consequences. This~     study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in~     lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared~     to placebo.~   "
253393|NCT00234689|"~     Assessing the efficacy of Naltrexone as augmentation to SSRI in patients with OCD~   "
253394|NCT00234676|"~     The primary objectives of the POETRY study are to assess the safety and tolerability of~     estrogen replacement therapy (ERT) in postmenopausal women with Parkinson's disease (PD) and~     to assess recruitment for a study of ERT in postmenopausal women with PD.~   "
253395|NCT00234663|"~     In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation~     (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator~     (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF~     due to a nonsense mutation. The main purpose of this study is to understand whether PTC124~     can safely increase functional CFTR protein in the cells of patients with CF due to a~     nonsense mutation.~   "
253396|NCT00234650|"~     The hypothesis to be tested is that position changes during the withdrawal phase of~     colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of~     the colon. Since adenomas are precancerous lesions the enhanced adenoma detection will~     increase the success of colorectal cancer screening programmes. This study will provide~     evidence for the value of position changes and encourage endoscopist to adopt position change~     as a routine in their practice.~      May 2007: protocol amendment to include additional prospective analysis using High Definition~     TV (HDTV).~   "
253397|NCT00234637|"~     This is a prospective, multicenter, open-label study. Following screening and baseline~     assessments, eligible patients will be switched to rivastigmine and will enter the 16 week~     run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in~     phase, patients who were not sufficiently stabilized on rivastigmine alone will receive~     add-on memantine to their rivastigmine treatment; patients who were stabilized on~     rivastigmine alone will have completed and be discontinued from the study.~   "
253398|NCT00234624|"~     This 1-year project is intended to study the hemodynamic changes of poratal and hepatic~     artery during living related liver transplantation. We hypothesize that after right~     hepatectomy for living related liver transplatation, portal vein overflow will change the~     remnant liver contour and result in liver hyperplasia.~   "
253399|NCT00234611|"~     Currently, the majority of heart failure patients who qualify for and receive a cardiac~     resynchronization therapy (CRT) device feel better than before their implant. However, there~     are some patients who do not improve after the implant. Michigan Heart is sponsoring a~     research study called LOCATE-Pilot to help understand whether the information from an~     echocardiogram, performed before implanting the CRT device, improves patients’ responses to~     CRT. This is being done by evaluating your heart’s function with an echocardiogram, to~     measure your heart’s response during therapy. The study hypothesis is that response to CRT~     may be optimized by guiding left ventricular lead placement to the maximally delayed, viable~     basal segment of the left ventricle.~   "
253400|NCT00234598|"~     This study tests whether special oral care provided by nurses to critically ill patients who~     are on a breathing machine (mechanical ventilator) can help to reduce the build-up of dental~     plaque on the teeth and reduce the risk of pneumonia.~   "
253401|NCT00234585|"~     This study is designed to demonstrate the safety and efficacy of using a protective~     device/drug to prevent renal injury during renal artery stenting and to assess whether the~     preventative effects are measurable and if there is a differential treatment effect for~     either device alone or in combination.~   "
253402|NCT00234572|"~     The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo~     after a single injection. Effectiveness and safety were then also assessed following four~     fixed-dose injections and after one year of treatment given at titrated doses.~   "
253403|NCT00234559|"~     The purpose of this study is to determine:~        1. If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of~          angiogenic markers compared to moist wound therapy.~        2. If VAC® therapy results in increased angiogenesis compared to moist wound therapy.~   "
253404|NCT00234546|"~     The aim of this clinical study is to investigate the efficacy and safety of Dysport® in~     patients with early onset of upper limb spasticity within 2-12 weeks after stroke.~   "
253405|NCT00234533|"~     The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq~     treated children, using newly developed capillary blood spot IGF-1 measurement technology.~   "
253406|NCT00234520|"~     The aim of the study is to compare the risk of acromegaly patients developing valvular~     regurgitation when receiving lanreotide or octreotide~   "
253407|NCT00234507|"~     The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo~     by assessing functional disability in blepharospasm.~   "
253427|NCT00234221|"~     This study will compare three alternative interventions in the emergency department (ED) to~     promote substance abuse assessment, referral, and treatment entry: 1) a 5 session~     strengths-based case management model (SBCM); 2) a 2-session motivational enhancement therapy~     (MET); or 3) a one-time brief informational feedback (BIF) session. The primary outcome~     variables for this trial include follow-through on receiving an assessment and referral, and~     treatment engagement. Additional outcomes include degree of treatment completion,~     alcohol-related measures, health service utilization, health status changes, and psychosocial~     factors.~   "
253408|NCT00234494|"~     Cisplatin is a very important agent for the treatment of TCC as it has a single agent~     response rate of approximately 15%. However, it has been most important as a part of~     combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single~     agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%,~     including some complete responses (CR), with minimal toxicity in patients with advanced~     bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced~     for use in combination with cytotoxic chemotherapy to delay time to disease progression in~     patients with metastatic solid tumors.~      This trial is designed to further assess the efficacy, safety and tolerability of this~     regimen in this patient population.~   "
253409|NCT00234481|"~     The purpose of this study is to assess the safety and tolerability of different doses of~     XL844 when given orally to adults with recurrent or refractory chronic lymphocytic leukemia~     or small lymphocytic lymphoma.~   "
253410|NCT00234468|"~     The aim of the study if to determine if Iressa can prolong the period of time without any~     disease worsening (Time to progression) in patients previously treated with combined therapy~     such as surgery and chemotherapy with or without radiotherapy or chemotherapy and~     radiotherapy~   "
253411|NCT00234455|"~     The objective of this study is to assess the feasibility and safety of the sirolimus-coated~     Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.~   "
253412|NCT00234442|"~     The aim of the study is to determine if Iressa is effective in the treatment of Brain~     metastases from NCSLC~   "
253413|NCT00234429|"~     The primary objective of this study is to compare the activity of raltitrexed and ZD1839~     versus raltitrexed alone as second line chemotherapy in subjects with colorectal carcinoma by~     estimating progression free survival (PFS) in each treatment arm.~   "
253414|NCT00234416|"~     The primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour~     intravenous (iv) infusion that can be administered in combination with ZD1839 250 mg once~     daily and a standard course (45 Grays [Gy]) of radiotherapy in patients with locally~     advanced, unresectable pancreatic cancer.~   "
253415|NCT00234403|"~     The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose~     of fulvestrant 250 mg im once a month will be evaluated in female patients with~     histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer~   "
253416|NCT00234390|"~     The purpose of this study is to investigate the ability of budesonide, given during episodes~     of troublesome lung symptoms to reduce further symptoms in infants and young children at risk~     of developing asthma~   "
253417|NCT00234377|"~     The purpose of this study is to document the clinical benefit of quetiapine (Seroquel)~     sustained release (SR) after switching from another ongoing antipsychotic treatment,~     regardless of the reason for the switch.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
253418|NCT00234364|"~     In a blinded echocardiographic study we investigate the frequency of valvular abnormalities~     in a group of Parkinson patients treated with either ergot derived dopamine agonists~     (pergolide and cabergoline) or non-ergot derived dopamine agonists (pramipexole and~     ropinirole). The ability to detect patients with valvular abnormalities by clinical approach~     is examined.~   "
253419|NCT00234338|"~     The purpose of this study is to estimate the local and systemic tolerability of Prevenar in~     children ages 2 to 5 years old in usual care settings.~   "
253420|NCT00234312|"~     The purpose of the study is to evaluate the efficacy and safety of flexible doses of~     escitalopram (Lexapro) compared to sertraline (Zoloft) for treatment of Dysthymic Disorder.~   "
253421|NCT00234299|"~     Aspirin affects many physiological processes through its anti-inflammatory actions. Various~     cancers, including prostate cancer, appear to utilize inflammatory signals to facilitate~     their growth and progression.~      We hypothesize that oral aspirin acts directly on prostate epithelial cells to alter~     COX-2-related metabolism and inhibit prostate cell growth.~   "
253422|NCT00234286|"~     The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a~     six-site implementation study to evaluate a multi-component, education-based intervention to~     improve the quality of end-of-life care provided in VA Medical Centers.~   "
253423|NCT00234273|"~     The principal objective is to assess and analyze the effects of a six month programme in~     Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance~     among type 2 diabetics.~   "
253424|NCT00234260|"~     GENOA, the Genetic Epidemiology Network of Arteriopathy, consists of a network of three field~     centers and biochemical and genetic core labs to study the common polymorphic genetic~     variations to determine individual differences in blood pressure and essential hypertension~     in 1,500 sibling pairs in three racial groups. Linkage analyses are performed using an~     extensive array of candidate genes and anonymous markers throughout the genome.~   "
253425|NCT00234247|"~     The purpose of this study is to look at the long term consequences of prematurity in infants~     treated with inhaled nitric oxide (iNO) while in the neonatal intensive care unit.~   "
253426|NCT00234234|"~     Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease which is~     characterized by joint inflammation (clinical involvement), by osteo-cartilaginous lesions~     (structural damage) and generally by bone involvement. All those features lead to great~     disability. Because it represents a major problem of the public health care system, RA has~     been selected as one of the main objectives of the government for the next five years.~      RA patients who do not respond to DMARDs require a treatment by TNF-a blocking agents.~     However, no information is available to predict the clinical, structural and bone responses~     to those new drugs that can be responsible of severe side-effects. Moreover, they are~     particularly expensive since their yearly cost is estimated between 75000 and 112500 k euros~     for the G4 region.~      The purpose of the present research project is to determine potential predictive factors of~     the response to a new TNF-a blocker ie adalimumab. To address this question, several~     investigations will be performed including measurement of different blood markers,~     particularly bone markers, well-defined autoantibodies and new autoantibody populations~     identified by proteomic analysis, large-scale analysis of gene expression with cDNA arrays~     from blood mononuclear cells, and use of different imaging tools.~      The criteria of judgement will be the clinical, structural and bone responses to those new~     agents.~      This study requires the recruitment of about 100 patients receiving adalimumab for a 1-year~     period.~      At the end of the study, we hope to identify predictive factors of the response to~     adalimumab, which will lead to a better management of this TNF-a blocker. Indeed, they will~     be prescribed only for the patients who are likely to respond to those drugs. Thus, this~     study should allow to elaborate theranostic algorithms. Such an approach will have great~     benefits for the patients: more rapid efficacy, less severe side-reactions and lower costs.~   "
253428|NCT00234208|"~     Multicenter, randomized controlled study to compare early mini-invasive thoracoscopy to~     simple chest tube drainage in complicated parapneumonic effusions or pleural empyema. 100~     patients will be recruited. Follow-up will be 3 months. It will be looked at the rate medical~     cure, the need for secondary interventions, death and duration of hospital stay. In a nested~     trial in 20 patients the intrapleural pharmacokinetics of linezolid (approved antibiotic~     agent) will be measured.~   "
253429|NCT00234195|"~     -  To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment~          of Major Depressive Disorder in women with breast cancer.~        -  To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these~          patients~   "
253430|NCT00234182|"~     We conducted a randomized controlled trial of adjuvant interferon therapy in patients with~     predominantly hepatitis B-related hepatocellular carcinoma (HCC) to investigate whether the~     prognosis after hepatic resection could be improved. Since February 1999, patients with no~     residual disease after hepatic resection for HCC were randomly assigned with stratification~     by pTNM stage to receive no treatment (control group), interferon alpha-2b 10 MIU/m2 (IFN-I~     group) or 30 MIU/m2 (IFN-II group) thrice weekly for 16 weeks. Enrollment to the IFN-II group~     was terminated from January 2000 because adverse effects resulted in treatment~     discontinuation in the first 6 patients. By June 2002, 40 patients each had been enrolled~     into the control group and IFN-I group. The baseline clinical, laboratory and tumor~     characteristics of both groups were comparable. The 1- and 5-year survival rates were 85% and~     61%, respectively for the control group and 97% and 79%, respectively for the IFN-I group~     (P=0.137). After adjusting for the confounding prognostic factors in a Cox model, the~     relative risk of death for interferon treatment was 0.42 (95% CI 0.17 - 1.05; P=0.063).~     Exploratory subset analysis showed that adjuvant interferon had no survival benefit for pTNM~     stage I/II tumor (5-year survival 90% in both groups; P=0.917) but prevented early recurrence~     and improved the 5-year survival of patients with stage III/IVA tumor from 24% to 68%~     (P=0.038). In conclusion, in a group of patients with predominantly hepatitis B-related HCC,~     adjuvant interferon therapy prevented early recurrence and improved survival in those with~     pTNM stage III/IVA tumors.~   "
253431|NCT00234169|"~     Hematopoietic stem cells (HSC) are used to support the administration of high dose~     chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5~     million HSC per kilogram are required. HSC are collected from the bone marrow by using drugs~     such as G-CSF (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream.~     HSC are collected from the bloodstream using an apheresis machine. Between 5 and 60% of~     patients fail to mobilize the minimum HSC dose required for safe transplantation, and this~     trial is investigating a way to enhance mobilization to overcome this problem. This trial~     aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when~     used in conjunction with G-CSF. Patients will undergo two mobilization procedures. They will~     be given G-CSF alone, or a combination of the study drug plus G-CSF, and their stem cells~     will be collected. A comparison group of patients will be given G-CSF alone for both~     mobilizations. Stem cells collected from patients in this trial will be frozen and stored~     until they are required for transplantation into that patient. At that time, patients will be~     monitored for how well they recover from their high dose chemotherapy and HSC~     transplantation.~   "
253432|NCT00234156|"~     This study will evaluate how a common dietary sugar (fructose) raises blood fats~     (triglycerides). We will determine whether the production of fat from fructose is higher in~     dialysis patients compared to healthy volunteers. Dialysis patients have high levels of~     hormone-like substances called cytokines that may increase blood fats. The results will help~     set better guidelines for diets for the general population and patients with kidney disease~     who are at high risk for heart attack and stroke.~      There will be one or two outpatient screening visit(s) and a one-week (6 nights) stay at the~     Rockefeller University Hospital.~   "
253433|NCT00234143|"~     Myelodysplastic syndromes (MDS) are acquired clonal disorders of the bone marrow. The~     clinical consequences of MDS are bone marrow failure and a predisposition to develop acute~     myeloid leukaemia (AML). Patients with 'low risk MDS' have less than 10% myeloblasts in the~     marrow and include the World Health Organization (WHO) subtypes refractory anaemia (RA),~     refractory anaemia with ring sideroblasts (RARS) and refractory anaemia with excess blasts-I~     (RAEB-I). This group of patients has a relatively low risk of leukaemic transformation and~     the major clinical problem is the manifestation of bone marrow failure. Up to 80% of these~     patients become red cell transfusion dependent. To date, the only curative therapy is~     allogeneic stem cell transplantation. Unfortunately, a median age at diagnosis of > 65 years~     excludes this type of therapy for most patients with MDS. The aim of treatment is, therefore,~     supportive therapy. Long term red cell transfusion therapy carries the problems of acute~     transfusion reactions: iron overload, alloantibody formation, poor venous access and the risk~     of transfusion transmitted infection. With time, such patients require increasing frequency~     of transfusion and obtain decreased length of benefit from transfusion. The quality of life~     of such patients is significantly reduced. Alternative therapies, therefore, aimed at~     promoting more effective haemopoiesis and reducing the need for red cell transfusion may~     improve quality of life, reduce the use of expensive resources such as red cells and iron~     chelation, and perhaps enhance survival.~      Combined darbepoetin alfa (Aranesp) plus G-CSF (Neupogen; filgrastim) in low risk MDS is~     better than best supportive care, with respect to haemoglobin and quality of life. The study~     will assess:~        -  the costs of this approach~        -  long-term outcomes~        -  clinical/laboratory parameters allowing early cessation of therapy in patients destined~          not to respond~   "
253434|NCT00234130|"~     This study will determine whether a new form of home hemodialysis carried out at night during~     sleep reduces blood levels of hormone-like substances called cytokines that may cause fatigue~     and increase blood fats and sugar. Participants will stay twice in the Rockefeller Hospital~     and receive a standard diet and blood testing. Training for nocturnal hemodialysis will be~     provided at the nearby Manhattan Dialysis Center of The Rogosin Institute, affiliated with~     The Rockefeller University.~   "
253435|NCT00234117|"~     The purpose of this study is to determine if 20mg BID of Rabeprazole is effective in~     controlling GERD in patients with concomitant bronchial asthma and to assess improvement in~     asthma after reflux control.~   "
253436|NCT00234104|"~     This drug is being developed to treat cardiac edema. The primary purpose of this study is to~     investigate the dose response for body weight in seven-day repeated oral administration of~     OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion~     secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted~     in Japan.~   "
253437|NCT00234091|"~     The purpose of this study is to determine when HIV infected children should begin taking~     anti-HIV medications in order to improve both patient quality of life and survival.~   "
253438|NCT00234078|"~     The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension~     in dry eye patients.~   "
253439|NCT00234065|"~     The purpose of this study is to investigate the efficacy of cilostazol in preventing~     recurrence of cerebral infarction and the safety of long-term administration of the drug (100~     mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral~     embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg,~     once daily).~   "
253440|NCT00234052|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium~     together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent~     non-small cell lung cancer.~   "
253441|NCT00234039|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving gemcitabine directly into the bladder may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with~     recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).~   "
253442|NCT00234026|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with~     newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma.~   "
253443|NCT00234000|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer~     cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of azacitidine when~     given together with arsenic trioxide and to see how well they work in treating patients with~     myelodysplastic syndromes.~   "
253444|NCT00233987|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell~     transplant may allow more chemotherapy to be given so that more cancer cells are killed.~     Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's~     lymphoma.~      PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in~     treating patients with progressive or recurrent Hodgkin's lymphoma.~   "
253445|NCT00233974|"~     RATIONALE: Comparing results of diagnostic procedures, such as molecular marker profiling,~     done before and after chemotherapy, may help doctors predict a patient's response to~     treatment and help plan the best treatment.~      PURPOSE: This phase II trial is studying how well molecular marker profiling of axillary~     lymph nodes works in predicting response in patients with locally advanced or metastatic~     breast cancer who are undergoing chemotherapy followed by surgery.~   "
253446|NCT00233961|"~     RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the~     bone marrow to the blood so they can be collected and stored until transplant.~      PURPOSE: This phase I trial is studying the side effects of G-CSF in stimulating peripheral~     stem cells for autologous stem cell transplant in treating patients with chronic phase~     chronic myeloid leukemia in remission.~   "
253447|NCT00233948|"~     RATIONALE: Antiviral drugs, such as nelfinavir mesylate, may help prevent cancer cells from~     spreading.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir~     mesylate and to see how well it works in treating patients with recurrent, metastatic, or~     unresectable liposarcoma.~   "
253448|NCT00233935|"~     The goal of this clinical research study is to test the safety of defined green tea catechin~     extract at different dose levels. Researchers also want to find out what effects, good and~     bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an~     increased risk associated with Barrett's esophagus. Chemoprevention is the use of certain~     drugs to keep cancer from forming, growing, or coming back. The use of defined green tea~     catechin extract may prevent esophageal cancer.~   "
253449|NCT00233922|"~     Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining~     appropriate consent, they are entered into either a control arm where reconstruction of the~     orbit is done with a titanium mesh (established practice) or the experimental arm where~     reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are~     followuped at 1 week, 1 month, 3 months, 6 months & 12 months. CT scan of the orbits are~     performed preop, 6 months & 12 months. End point is the 12 month follow-up appointment.~     Visual acuity, range of motion, enophthalmos & diplopia are assessed in follow-up.~   "
253450|NCT00233909|"~     Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing~     or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making~     cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO)~     is more effective with or without zosuquidar in treating acute myeloid leukemia.~   "
253451|NCT00233896|"~     Patients with gastrointestinal graft-vs.-host disease are randomized to oral beclomethasone~     dipropionate (BDP) 8 mg/day or identical placebo tablets for 50 days, along with a 10-day~     induction course of prednisone. At study day 10, patients whose symptoms of GVHD are under~     control undergo a rapid prednisone taper over 7 days, while study drug is continued to study~     day 50. After discontinuation of study drug at study day 50, patients are followed for 30~     additional days, to study day 80. The primary endpoint is treatment failure by day 50, that~     is, a flare of the symptoms of GVHD that requires immunosuppressive therapy. Secondary~     endpoints are treatment failure by day 80, treatment-emergent adverse events, and survival at~     transplant day 200. The hypothesis to be tested is that a topically-active corticosteroid~     (beclomethasone dipropionate, BDP), taken orally, would allow rapid tapering of prednisone~     while maintaining control of intestinal GVHD.~   "
253452|NCT00233883|"~     The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free~     injection device used to administer Fuzeon, compared with the standard needle/syringe~     supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and~     the target sample size is <100 individuals.~   "
253453|NCT00233870|"~     The purpose of this survey is to identify any concerns regarding the following efficacy and~     safety-related issues in clinical practice with the new drugs Fabrazyme for intravenous~     infusion 5mg and Fabrazyme for intravenous infusion 35mg and to confirm the safety of~     these products in long-term use in the clinical setting.~        1. New adverse drug reactions (ADRs) that cannot be predicted from the Precautions (in~          particular, clinically significant ADRs)~        2. The incidence of ADRs under the actual conditions of use of the drug~        3. Causal factors that might potentially affect safety~        4. Efficacy evaluation in long-term use~      This survey will be conducted in accordance with the approval condition established for~     Fabrazyme:~      To conduct a special surveillance of Efficacy and Safety in long term treatment and~     Pediatric with the drug.~   "
253454|NCT00233857|"~     The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in~     relief of acute postoperative pain and in reduction of analgesics consumption on demand and~     their side effects in patients after ambulatory knee arthroscopy~   "
253455|NCT00233844|"~     The aim of the trial is to study the possible mechanism of the pain reducing effect of CT at~     peripheral venipuncture~   "
253456|NCT00233831|"~     The aim of the study was to test whether the exposure to electromagnetic millimeter waves -~     Millimeter Wave Therapy (MWT) is effective for relief of acute postoperative pain in patients~     after elective unilateral total knee arthroplasty (TKA)~   "
253457|NCT00233818|"~     The objective of this study is to assess the performance and safety of a formulation of the~     antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent~     mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de~     novo coronary artery lesions.~   "
253458|NCT00233805|"~     The main objective of this study is to assess the safety and effectiveness of the sirolimus~     coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native~     coronary lesions as compared to the bare metal Bx VELOCITY balloon-expandable stent. Both~     stents will be mounted on the Raptor Rapid Exchange Delivery Stent System.~   "
253459|NCT00233792|"~     This is a single center, non-randomized study. Patients will be treated with the sirolimus~     coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have~     a repeat angiography at four months and will be followed for twelve months post-procedure.~   "
253460|NCT00233779|"~     The objective of this study is to assess the performance and safety of a sirolimus-eluting,~     heparin-coated, cobalt chromium balloon-expandable stent (Small Vessel Stent) in patients~     with de novo native coronary artery lesions in small vessels as compared to historical data~     from small vessel patients in the RAVEL trial receiving the Sirolimus-eluting Bx VELOCITY™~     stent.~   "
253461|NCT00233766|"~     The objective of this study is to assess the performance and safety of two reduced sirolimus~     doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX)~     Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.~   "
253462|NCT00233753|"~     Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck,~     intracranial, saccular aneurysms arising from a parent vessel~   "
253463|NCT00233740|"~     The main objective of this study is to monitor the safety and effectiveness of the OptEase™~     Permanent Vena Cava (IVC) Filter~   "
253464|NCT00233727|"~     The study measures the impact of screen-and-treat on the prevalence of high-grade cervical~     intraepithelial neoplasia and cancer (CIN 2+). It is a three-arm, randomized clinical trial~     comparing two screen-and-treat approaches to delayed evaluation as a control. The primary~     outcome is biopsy-confirmed CIN 2+ at 6 months and significant complications within 6 months~     of randomization with continued follow-up to detect CIN2+ and other complications up to 36~     months post-randomization.~   "
253465|NCT00233714|"~     The main objective of this study is to assess safety and effectiveness of double dose~     sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary~     lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.~   "
253466|NCT00233701|"~     The overall aim of the registry is to develop a longitudinal, observational database that is~     focused on adult patients with Normal Pressure Hydrocephalus (NPH) that can be used as a~     source of clinical information for individual surgeons, as well as a national data repository~     for scientific inquiry and publications.~   "
253467|NCT00233688|"~     The objective of this clinical study is to assess the safety and effectiveness of the Cordis~     Endovascular Quantum LP™ Stent Graft System.~   "
253468|NCT00233675|"~     To assess the long-term safety and tolerability of tiagabine treatment in patients with~     generalized anxiety disorder (GAD).~   "
253469|NCT00233662|"~     The purpose of this study is to determine whether repeat courses of alefacept, administered~     intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving~     standard dermatology treatments.~   "
253470|NCT00233649|"~     The purpose of this study is to determine in DM II patients the efficacy of Crestor in~     obtaining the new European LDL cholesterol guidelines.~   "
253471|NCT00233636|"~     The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in~     shrinking tumour dimensions.~   "
253472|NCT00233623|"~     The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan,~     5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening~     (Time to Progression) in patients with metastatic colorectal cancer.~   "
253473|NCT00233610|"~     The aim of the study is to investigate the efficacy of different dosing and scheduling of~     Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in~     patients with prostate cancer.~   "
253474|NCT00233597|"~     The study will evaluate the safety and efficacy of a new intravenously administered iron drug~     to treat anemia in patients on hemodialysis.~   "
253513|NCT00233077|"~     The purpose of this study is to determine whether patient-assistance programs as compared~     with usual care will help women with early stage breast cancer receive appropriate~     treatments.~   "
253475|NCT00233584|"~     This prospective study will evaluate the feasibility of the defined decision tree for the~     treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of~     any troublesome lower respiratory symptoms are treated according to a strictly pre-defined~     multi-steps treatment algorithm until the age of 6 years.~   "
253476|NCT00233571|"~     The purpose of the study is to assess the long-term safety and clinical efficacy of~     adalimumab in patients with rheumatoid arthritis~   "
253477|NCT00233558|"~     The purpose of the study is to evaluate the clinical efficacy of scheduled versus free~     reduction of steroid treatment in patients with active RA treated with adalimumab + MTX~   "
253478|NCT00233545|"~     Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent~     antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L~     braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This~     trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis~     in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony.~     Standard dose regimens will be used for both drugs.~   "
253479|NCT00233532|"~     The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor,~     trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.~   "
253480|NCT00233519|"~     The aim of this study is to investigate the safety and feasibility of daily subcutaneous~     injections of recombinant IGF1 complexed with IGF binding protein 3 (SomatoKine-INSMED) as a~     treatment for muscle wasting and weakness in myotonic dystrophy type 1.~   "
253481|NCT00233506|"~     -  CpG has the potential to stimulate the immune system~        -  this study will evaluate the safety of CpG given sub-q or IV~        -  purpose is to measure biological changes in CLL cells after receiving CpG~   "
253482|NCT00233493|"~     The objective is to demonstrate person-to-person spread of dermatophytes of the skin and~     nails among family members, as measured by fungal culture and DNA typing of the dermatophytes~     isolated.~   "
253483|NCT00233480|"~     The goal of the investigators' study is to further understand the potentially beneficial~     effects of statin therapy in patients with heart failure. It is hypothesized that statins~     will 1) increase the heart's pumping ability 2) improve functioning of the sympathetic~     nervous system and 3) decrease immune activation in heart failure.~   "
253484|NCT00233467|"~     The main purpose is to show the percentage of patients taking antipsychotics with PTSD by~     looking at approximately ten year's worth of data from 1994 through 2004. We will also~     determine the type and dose of antipsychotics the patients received, and to determine how~     many of those patients had psychotic versus nonpsychotic symptoms. We will be obtaining this~     data from the VISN 7 Corporate Data Warehouse. We hypothesize that there has been an overall~     increase in antipsychotic use in patient's with PTSD over the last 10 years.~   "
253485|NCT00233454|"~     The safety and efficacy of midostaurin (PKC412), a novel investigational drug, will be~     evaluated on the basis of response rate, when administered to patients with aggressive~     systemic mastocytosis (ASM) or mast cell leukemia (MCL)~   "
253486|NCT00233441|"~     Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose~     to be further investigated in the maintenance of sinus rhythm after electrical,~     pharmacological or spontaneous conversion of AF/AFL.~   "
253487|NCT00233428|"~     The purpose of this study is to see if there is a racial and/or gender difference in platelet~     aggregation.~   "
253488|NCT00233415|"~     The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy~     with radiosurgery for locally advanced pancreas cancer.~   "
253489|NCT00233402|"~     The purpose of this study is to document the additional detection of papillary bladder cancer~     and the reduced early recurrence due to the improved detection and resection of these tumors~     after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder~     cancer.~   "
253490|NCT00233389|"~     To examine the efficacy of continued administration of rebamipide following bacteria~     eradication therapy in patients with H. pylori-positive active gastric ulcer in a~     placebo-controlled, double-blind study~   "
253491|NCT00233376|"~     We developed a computerized decision support system for prescription of antibiotics to~     inpatients. The purpose of the study is to assess the performance of the system in different~     wards, in three different hospitals, in three countries.~   "
253492|NCT00233363|"~     The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide~     on dry mouth in patients with Sjögren’s syndrome in comparison with placebo.~   "
253493|NCT00233350|"~     3D ultrasound is a new modality used in image guided neurosurgery. a multicentre study is~     started for the evaluation of this tool as a means for achieving total resection of brain~     tumors at greater safety.~   "
253494|NCT00233337|"~     This study will assess the safety and efficacy of co-artemether in the treatment of acute~     uncomplicated P. falciparum malaria in returning non-immune travellers~      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES~   "
253495|NCT00233324|"~     This study compared the use of continuous positive airway pressure initiated at birth with~     the early administration of surfactant administered through a tube in the windpipe within 1~     hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these~     infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor~     their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped~     determine whether or not these two management strategies affect chronic lung disease and~     survival of premature infants.~   "
253496|NCT00233311|"~     The purpose of this research study is to determine whether eating a fast food meal (high in~     saturated fat) will result in greater increases in inflammatory markers than eating a meal~     with low levels of saturated fat and higher levels of mono-unsaturated fat. This study is a~     first step in learning about how dietary fat intake can directly impact risk factors for~     heart disease, diabetes and obesity.~   "
253497|NCT00233298|"~     The purpose of this study is to find out whether the hormones in the taste buds are affected~     by tasting and eating food, and also whether these hormone levels are affected by an increase~     in body weight or type 2 diabetes.~   "
253498|NCT00233285|"~     To investigate gene-environment interactions that may influence susceptibility to respiratory~     illness in children living in highly polluted areas in California.~   "
253499|NCT00233272|"~     Background:~      - The Baltimore Longitudinal Study of Aging (BLSA) is a clinical research program on human~     aging that began in 1958. Volunteers of different ages join the study when they are healthy,~     and have follow-up visits for life. Visits last for multiple days. Participants are evaluated~     for many physical elements as well as for brain function. Physical tests are given.~     Information on mood, personality, and social aspects of life is also collected. This program~     has contributed more than any other research project to our understanding of aging.~      Objectives:~      - To characterize the many aspects of the aging process and learn how people can successfully~     adapt to aging.~      Eligibility:~      - Healthy individuals at least 20 years old.~      Design:~        -  Participants will receive a booklet and video describing the tests they will take.~        -  During a 3-day visit at the study hospital, participants will take the following tests:~        -  Urine will be collected for 24 hours. Blood samples will be taken. A small piece of~          muscle tissue may be collected by a needle.~        -  A medical questionnaire and a physical exam will be given.~        -  Participants hearts will be tested, including with blood pressure tests and electronic~          monitors. They will breathe into a tube to test their lungs.~        -  Participants will perform several exercises, including treadmill walking.~        -  Vision, hearing, and taste will be tested.~        -  Bone and joint X-rays may be taken.~        -  Imaging tests will be given, such as an MRI.~        -  Participants will answer questions to test their mental abilities.~        -  Participants will return for follow-up visits every few years for life. The tests listed~          above will be given at every visit.~   "
253500|NCT00233259|"~     The Viva Bien! trial will comprehensively evaluate a multiple risk factor intervention (diet,~     physical activity, stress management, social support, and smoking cessation) in a randomized~     effectiveness trial, which will be offered in English and Spanish to diabetic Latinas.~   "
253501|NCT00233246|"~     This study will compare patients with mild to moderate prolongation of the INR test who~     receive FFP infusions prior to invasive hepatobiliary procedures for bleeding complications~     to patients who do not receive FFP infusions. Bleeding complications will be defined as~     meeting one or more of the following:~        1. Intrahepatic hematoma greater than 1 ml/kg of patient weight as seen on post-procedure~          ultrasound examination performed between 4 to 30 hours after the procedure.~        2. Greater than 1.6g/dL hemoglobin decline measured within 4 to 30 hours post-procedure~          compared with the pre-procedure value, in the absence of another identified bleeding~          source to account for the hemoglobin drop.~        3. Need for transfusion of packed red blood cells for procedure-related bleeding while in~          the study.~      The secondary endpoints of this study will be: 1) The need to perform subsequent procedures~     (angiography, embolization, additional imaging study including computerized tomography (CT)~     scan, surgery) to diagnose or to arrest procedure-related bleeding OR the need for subsequent~     medical therapies (FFP, coagulation factor concentrates, anti-fibrinolytics) to treat~     procedure-related bleeding between time of procedure and the end of patient's time in the~     study. If necessary, the relationship of procedure or therapy to procedure-related bleeding~     will be assessed by an adjudication panel; 2) The predictive value of INR; 3) The effect of~     study treatment on change in INR; 4) The cost of preventing one bleed; 5) The predictors of~     bleeding other than INR; 6) The number of transfusion-associated adverse events encountered~     to prevent one bleed; and 7) The effect of treatment on bleeding grade.~   "
253502|NCT00233233|"~     This study will examine how the assessment mode influences the validity of self-reported~     adherence to asthma therapy. Self-reported adherence to asthma therapy data will be collected~     using one of three randomized assessment modes (interview, computer, or telephone).~   "
253503|NCT00233220|"~     The purpose of this study is to test the effectiveness of a multi-component evidence-based~     intervention that targets both patients and physicians, in improving BP control rates in~     patients followed in 30 Community/Migrant Health Centers (C/MHCs).~   "
253504|NCT00233207|"~     This is a phase II, randomized, double-blind, placebo-controlled, safety and efficacy study~     of a recombinant chimeric monoclonal antibody against CD14 (IC14) in hospitalized patients~     with acute lung injury (ALI).~   "
253505|NCT00233194|"~     The purpose of this research is to study and improve the methods used to detect childhood~     breathing problems during sleep that can affect daytime behavior at home and school. Early~     diagnosis of these sleep disorders may allow doctors to treat children at a time when the~     consequences can still be reversed.~   "
253506|NCT00233181|"~     To evaluate the effectiveness of a Head Start-based early intervention for designed to~     improve asthma management skill and practices of parents, pre-school children and Head Start~     staff.~   "
253507|NCT00233168|"~     This study will determine the differential cumulative mean number of isoniazid (INH) pills~     completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1)~     peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2)~     self-esteem/life skills counseling alone. The study will also estimate the costs and cost~     effectiveness of peer adherence coaching versus control procedures; this will be done from a~     provider and societal perspective.~   "
253508|NCT00233155|"~     The purpose of the study is to evaluate the safety and efficacy of NGX-4010 administered at~     intervals of no less than 12 weeks over 1 year, based on the presence or return of pain, for~     the treatment of painful HIV-AN and PHN. Participation is limited to former study subjects~     from previous trials of NGX-4010 at selected sites.~   "
253509|NCT00233142|"~     This study will determine whether the psychological benefits of expressive writing extend to~     diabetic patients, how long the benefits will last, and whether additional expressive writing~     booster sessions will lead to greater and more sustained improvement in diabetes symptoms~     and well-being.~   "
253510|NCT00233129|"~     This is a randomized clinical trial which compares a standard day treatment program for~     individuals with TBI with the Executive Plus program; the latter emphasizes training of~     attention, emotional self-regulation and problem solving. The goal of the Executive Plus~     program is to maximize executive functioning, as well as the long-term outcomes of community~     participation and satisfaction with daily life.~   "
253511|NCT00233103|"~     Randomized clinical trial of sertraline vs. placebo for post-TBI depression~   "
253512|NCT00233090|"~     Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.~   "
253514|NCT00233064|"~     The purpose of this study is to measure the rate of anti-palivizumab antibodies (also~     referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid~     or lyophilized formulation of palivizumab. This study will compare the number and percentage~     of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized~     formulation of palivizumab.~   "
253515|NCT00233051|"~     The purpose of this research study is to determine whether analysis of genes in sputum is a~     useful noninvasive technique for measuring response to drugs in patients with COPD.~      We propose to use polymerase chain reaction to evaluate gene expression in induced sputum~     from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This~     study is designed to determine whether changes in expression of previously-identified~     inflammatory markers in induced sputum can be detected in response to drug therapy in COPD~     and to evaluate potential differences in the expression of these markers in adult smokers~     with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic~     analysis of therapeutic response as well. Changes in sputum gene expression in response to~     treatment will be the primary outcome variable in this study. Secondary outcomes will include~     changes in lung function, as well as changes in induced sputum inflammation. These endpoints~     will be evaluated before and directly after 6 weeks of randomly-assigned treatment with~     either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination~     DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.~   "
253516|NCT00233038|"~     The purpose of the study is to learn about a new treatment for pancreatic cystic lesions. The~     injection of alcohol into cysts is a common way of treating cysts of the liver, kidney, and~     thyroid. We would like to find out if injection of alcohol would be useful for the treatment~     of pancreatic cystic lesions. The treatment with alcohol will use endoscopy and endoscopic~     ultrasound (procedures that use a scope that is placed through your mouth and into your~     stomach). We hypothesize that more than half of the cysts which are injected with ethanol~     will resolve.~   "
253517|NCT00233025|"~     To test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of~     the reduction of pain severity as measured by the average pain item of the BPI and the PGI-I~     in patients with fibromyalgia syndrome.~   "
253518|NCT00233012|"~     The purpose of this study is to evaluate the pharmacokinetics safety and tolerability of~     topiramate in infants aged 1-24 months with refractory partial-onset seizures. Topiramate is~     an antiepileptic drug approved for use in adult and pediatric patients (aged 2 to 16 years)~     with refractory partial onset seizures (POS) with or without secondarily generalized~     seizures, primary generalized tonic clonic seizures, or Lennox-Gastaut syndrome (LGS).~   "
253519|NCT00232999|"~     This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel~     anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic~     asthma and the related increased sensitivity of the airways to other substances, as well as~     to investigate a possible anti-inflammatory effect of the drug in the airways.~   "
253520|NCT00232986|"~     The goal of this study is to use three different survey methodologies to evaluate whether~     adolescents report on their knowledge, attitudes and behaviors on sexual and reproductive~     health issues differently based on the manner in which questions are asked.~   "
253521|NCT00232973|"~     The main purpose of the study is to compare treatment of non-infected venous leg ulcers using~     ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer~     compression bandaging and four-layer compression bandaging alone.~   "
253522|NCT00232960|"~     There is no consensus on the indication of postoperative radiotherapy for early stages oral~     and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck~     node metastasis, but most of the institutions do not give any post-operative treatment.~     Loco-regional control rates range between 80-85% at five years. Surgical margins molecular~     analysis for microsatellite instability (MSI) marker could help to select the high-risk~     patients who should receive postoperative radiotherapy. We expect to include 120 patients in~     five years and have 60 informative tumors for MSI marker. Patients with positive molecular~     margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular~     margins will not receive radiotherapy.~   "
253523|NCT00232947|"~     The goal of this study is to determine whether the immune responses induced by Fluviral, the~     investigational vaccine, are comparable to those induced by Fluzone, which is an influenza~     vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In~     addition, the study will compare the rate of reactions to the two vaccines, and the general~     health of persons who receive them over the 42 days after immunization.~   "
253524|NCT00232934|"~     The purpose of this study is to determine whether the association of Thalidomide to Melphalan~     and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.~   "
253525|NCT00232921|"~     Radiological study into the anatomical spread of caudal local anaesthetic in children age 1-7~   "
253526|NCT00232908|"~     This study will evaluate patient quality of life and tolerability of a HAART (highly active~     antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in~     clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use~     a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study~     treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
253527|NCT00232895|"~     Randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the~     pain of injection of the standard formulation~   "
253541|NCT00232713|"~     The Uterine Fibroid Pregnancy Registry is a USA and European-based registry designed to~     monitor pregnancies in women with uterine fibroids in order to~        1. estimate the risk ratio of birth defects in women with uterine fibroids who were treated~          or untreated during pregnancy and~        2. detect any pattern of birth defects among pregnancies in specific treatment groups.~      Those pregnant women exposed to various therapies used to treat uterine fibroids will be~     compared with those not exposed to treatment in order to detect any potential increase in the~     risk of major birth defects.~   "
253542|NCT00232700|"~     We intend to test in a randomized, rater blinded, placebo controlled, prospective study the~     primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the~     treatment of refractory major depression assessed with the Hamilton Depression Rating Scale~   "
253528|NCT00232882|"~     Angiotensin receptor antagonists (ARA), beta-blockers and diuretics do not seem to confer~     equivalent cardiovascular protection in hard outcomes clinical trials (beta blockers~     inferior). These results may be explained by differences in their effects on sympathetic~     activity, oxidative stress, inflammation and renin angiotensin system activation.~      How diuretic addition to first line therapy with ARAs and beta-blockers modulates~     neurohumoral and hemodynamic parameters is not well understood.~      The main hypothesis of this study is that an ARA (candesartan) combined or not with a~     diuretic will not increase sympathetic activity as much as a beta blocker (atenolol).~     Secondary hypothesis are of similar nature but relate to hemodynamic parameters, oxidative~     stress markers, inflammatory markers, or the renin angiotensin system.~      The main objective of this study is to assess and compare the effects of candesartan and~     atenolol and their combination with low dose diuretic therapy on the autonomic nervous~     system, hemodynamic parameters,on oxidative stress, on inflammatory markers, and on the~     renin-angiotensin system.~      Protocol sponsored by Astra Zeneca canada~   "
253529|NCT00232869|"~     The main objective of this study is to assess the safety and performance of the sirolimus~     coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the~     treatment of obstructive superficial femoral artery (SFA) disease in reducing percent~     in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to~     the uncoated SMART™ stent.~   "
253530|NCT00232856|"~     The main objective of this study is to assess the safety and effectiveness of the Cypher™~     sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an~     in-stent restenotic native coronary artery lesion.~   "
253531|NCT00232843|"~     The main objective of this study is to assess the performance of the Cordis SMART™ nitinol~     self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in~     comparison with balloon angioplasty only as determined by binary restenosis at one year.~   "
253532|NCT00232830|"~     The main objective of this study is to assess the effectiveness and safety of the CYPHER™~     (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint~     of target vessel failure (TVF) in subjects treated for acute myocardial infarction as~     compared to a bare metal stent.~   "
253533|NCT00232817|"~     The purpose of this study is to compare post-operative pain after anesthesia with either~     isoflurane or propofol. Each group will be further randomized to recieve intranasal nicotine~     or placebo inorder to detect potetial pronociceptive action of isoflurane.~      The study is a randomized, prospective, double-blinded controlled trial. Eighty adult women~     undergoing uterine surgery will be recruited for this study. Enrollment in this study is~     limited to women, because our animal studies suggest that females have a greater hyperalgesic~     response to volatile anesthetics than do males.~      The patient will be given one of two standard anesthetics for their surgery: isoflurane or~     propofol. We are interested in these two anesthetics because we seek to see if there exists a~     difference in their effects on a patient's perception of pain, as has been shown to be the~     case in animal studies but has not yet been studied in humans.~      The primary outcome variable will be postoperative pain, as measured by a numerical analog~     pain score (VAS) at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 120, and 1440 minutes~     postoperatively. Secondary outcome measures will include morphine utilization via PCA and~     hemodynamics variables including heart rate, systolic BP, and diastolic BP, all of which will~     be measured at the same time points as the VAS score.~   "
253534|NCT00232804|"~     The objective of this study is to establish the safety and efficacy of the treatment with~     Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary~     artery 2.5 -3 mm in lumen diameter, with lesion between 15 mm 30 mm in length, ) in native~     coronary arteries.~      The objective of this study is to document that the use of Cypher DES in these diabetic~     patients undergoing percutaneous revascularization for stenosis is safe.~      Safety will be assessed over a period of 12 months.~   "
253535|NCT00232791|"~     The main objective of this study is to assess the safety and effectiveness of the CYPHER~     SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de~     novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.~   "
253536|NCT00232778|"~     The objectives of this study are:~        1. To show a reduction in the late thrombosis (LT) rate following percutaneous~          revascularization using current interventional techniques with new stent placement and~          intravascular radiation therapy (IRT) with a long-term antiplatelet regimen (12 months)~          compared to the stented patients on short-term antiplatelet regimen (2 months) from the~          IRT arm of GAMMA I Trial.~        2. To show equivalence in the LT rate following percutaneous revascularization using~          current interventional techniques without new stent placement and IRT with a long-term~          antiplatelet regimen (6 months) compared to non-stented patients on short term~          antiplatelet therapy (2 months or less) from a pooling of the IRT arms of the GAMMA I,~          SCRIPPS, and WRIST Trials.~   "
253537|NCT00232765|"~     The main objective of this study is to assess the safety and effectiveness of the~     sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native~     coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent.~     Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.~   "
253538|NCT00232752|"~     The main objective of this study is to assess the safety and effectiveness of the~     sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de~     novo native coronary artery lesions.~   "
253539|NCT00232739|"~     The main objective of this study is to assess the safety and effectiveness of the~     sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de~     novo native coronary artery lesions.~   "
253540|NCT00232726|"~     Previously untreated patients with malignant melanoma receive a new chemotherapy drug~     currently under development. CP-4055 is given intravenously on days 1-5 every four weeks~     until complete response or disease progression.~   "
253543|NCT00232687|"~     The purpose of this clinical research study is to evaluate the safety and tolerability of two~     switching strategies from risperidone to aripiprazole over a period of 12 weeks in~     out-patients who are treated in a general psychiatric practice setting and who are currently~     experiencing efficacy and/or safety/tolerability issues while on risperidone.~   "
253544|NCT00232674|"~     To assess the effect of up to 4 years treatment with budesonide on progression of emphysema~     in patients with Chronic Obstructive Lung Disease.~   "
253545|NCT00232661|"~     The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which~     we already know to be well tolerated. The main objectives of this research study are to see~     whether using these drugs will shrink down tumours before surgery and to see if any shrinkage~     in the tumour affects the extent of surgery that is required.~   "
253546|NCT00232648|"~     This study is as an extension study of SD-004-0765, to assess the safety profile of long-term~     use of budesonide inhalation suspension in Japanese young children with bronchial asthma.~     Children completing study SD-004-0765 continued administration of budesonide inhalation~     suspension as judged by the investigator; the dose is adjusted as appropriate within the~     range of 0.25 to 1.0 mg per day administered once or twice daily, according to the symptoms.~   "
253547|NCT00232635|"~     Objectives~      Primary Objectives:~        -  Pilot Study: A preliminary assessment of the exposure and safety of oral A-60444 in~          post-stem cell transplant patients with RSV infection.~        -  Main Study: To determine the antiviral effect of oral A-60444 versus placebo in~          post-stem cell transplant patients with RSV infection and to assess the safety of oral~          A-60444 in post-stem cell transplant patients with RSV infection.~      Secondary Objectives:~        -  To study the pharmacokinetics of A-60444 in the presence of concomitant medications such~          as immunosuppressants and antifungals, in post-stem cell transplant patients with RSV~          infection.~      Sample Size: Six patients will be included in the open, pilot phase of the study and there is~     an option to include a further 22 patients into the main, placebo-controlled study, depending~     on the pilot study findings. An independent Data Safety Monitoring Board will assess the~     findings of the pilot study.~   "
253548|NCT00232622|"~     The optimal dosage and duration of administration of clot-dissolving medications for the~     treatment of patients with mechanical heart valves with clots is not known. We hypothesized~     that a large dose of the clot-dissolving medicine given initially (akin to the dose given in~     the treatment of heart attacks), might speed up the dissolution of the clot and rapidly~     restore the functioning of the mechanical heart valve.~   "
253549|NCT00232609|"~     The purpose of this research project is to further develop and test the effectiveness of a~     novel exercise system for wheelchair users, the Game Cycle.~   "
253550|NCT00232596|"~     This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed~     at 1200 mg/day, in three equally divided doses, compared with placebo in patients with~     epilepsy who are receiving up to three established antiepileptic drugs (AEDs).~   "
253551|NCT00232583|"~     The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic~     patients on two different treatment regimens: insulin and metformin versus glyburide,~     metformin and pioglitazone.~   "
253552|NCT00232570|"~     The primary hypothesis is that quetiapine will improve sleep in persons with Alzheimer's~     Disease (AD), with higher doses producing greater total sleep time and sleep efficiency.~   "
253553|NCT00232557|"~     This project is investigating whether application of a telecommunications system to the care~     of adult patients with asthma will improve self-management by enhancing compliance with~     preventive medication regimens and fostering the use of peak-flow-based action plans.~   "
253554|NCT00232544|"~     This study is investigating the effects of a telecommunications system designed to improve~     patient adherence with prescribed positive airway pressure (CPAP).~   "
253555|NCT00232531|"~     AIM 1 will test the hypothesis that elevation of high-density lipoprotein (HDL) through~     treatment with Niaspan will accelerate the regression of atherosclerotic plaque in patients~     with established atherosclerosis. The investigators will therefore study patients with~     atherosclerosis in the aorta and carotid artery. Plaque quantification will be with magnetic~     resonance imaging (MRI).~      AIM 2 will assess the ability of Niaspan to improve endothelial function in patients with~     coronary artery disease and type II diabetes mellitus, who typically have low high-density~     lipoprotein cholesterol (HDL-C), and high risk of cardiovascular events.~   "
253556|NCT00232518|"~     There has been considerable debate over the last 30 years about the interaction between~     asthma and parasitic infection. It has been suggested that at least part of the reason for~     the increasing prevalence of asthma in the developed world is a decrease in parasite~     infections resulting from improved living conditions with economic development. Our previous~     studies in Ethiopia suggest that hookworm infection may be particularly important in this~     process.~      To establish definitively whether parasites can protect against allergic disease, and~     specifically asthma, ultimately requires a randomised clinical trial of parasite infection in~     patients with asthma. We, the researchers at the University of Nottingham, have completed a~     study in normal volunteers to establish the dose of hookworms necessary to generate infection~     at the level shown to be protective in population surveys, and shown that infection is well~     tolerated. We now propose two randomised placebo-controlled double blind clinical trials. The~     first will test the effectiveness of hookworm infection in reducing symptoms in allergic~     patients with rhinitis, and will also serve to allow us to check the likely safety of~     hookworm infection in asthma. Assuming that the results of this study are favourable, we will~     then carry out a trial of hookworm infection in asthma. We will also take the opportunity~     during both of these studies to investigate the cellular mechanisms of the effect of hookworm~     infection on the immune system.~   "
253557|NCT00232505|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. It is not yet known whether~     giving cetuximab together with carboplatin is more effective than giving cetuximab alone in~     treating metastatic breast cancer.~      PURPOSE: This randomized phase II trial is studying cetuximab and carboplatin to see how well~     they work compared with cetuximab alone in treating women with estrogen receptor-negative~     (ER-), progesterone receptor-negative (PR-) metastatic breast cancer.~   "
253558|NCT00232492|"~     The purpose of the study is to determine whether equal subanesthetic doses of racemic~     ketamine is equally effective on females and males after surgical removal of third molars~   "
253585|NCT00232141|"~     Study to determine if pregabalin is more effective than placebo in treating subjects with~     nerve pain associated with HIV neuropathy.~   "
253559|NCT00232479|"~     Dose dense therapy has been shown to increase survival in the adjuvant setting of breast~     cancer. It is unknown if dose dense therapy will improve survival in tumors that express~     her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and~     herceptin when used in a dose dense manner in patients with large breast cancers. The~     endpoint of pathologic complete response is used as a surrogate marker for survival.~   "
253560|NCT00232466|"~     Percutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression~     fractures of the spine. Five-thousand out of 12.000 patients (16.000 vertebral fractures/year~     in the Netherlands) present with sudden, severe back pain in the region of the fracture.Until~     recently, bed rest, analgesia and physical support were the only treatment options. After~     decades of performing PV, no large RCT with mid-term follow-up has been published.~      Design:~      This will be a multicenter (6 centers), prospective, randomised, intervention study. Eligible~     patients will be randomised for percutaneous vertebroplasty or conservative therapy.~      Study population:~      Age: 50 and older, vertebral fracture, level: thoracic vertebral body 5 (Th 5) or lower,~     osteopenia (T-score &lt; -1 SD), back pain for no more than 6 weeks and edema in the~     vertebrae on MR imaging~      Statistical analyses All analyses will be performed on an 'intention to treat' principle. The~     planned number of subjects will be 200 in total, 100 in each intervention arm.~      Economic evaluation:~      Cost-effectiveness will be assessed. The costs of the procedure and the medical treatment,~     and of visits to medical specialists, GP's and physical therapists will be compared.~      Time schedule:~      The total study will take 36 months~      Recruitment of patients (200) has been completed. In May 2009 the 1 year follow-up will be~     finished.~   "
253561|NCT00232453|"~     There is no established standard preoperative treatment in rectal cancer. Two large~     randomized studies in North America closed from lack of accrual; therefore the only method of~     assessing preoperative treatment in rectal cancer is from Phase II studies. This study builds~     on the experience at PMH gained in two previous studies which demonstrated a lower than~     expected toxicity with concurrent 5FU infusion and external radiotherapy. The current~     standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion~     225mg/m2. An increase of radiation dose and consequent increase in chemotherapy may improve~     the response rate, but may also increase toxicity. It is proposed to increase the dose of~     radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity~     and complete remission rate.~   "
253562|NCT00232440|"~     Radiation therapy has a well-established role in the treatment of Hodgkin's Disease and~     non-Hodgkin's Lymphoma. With technological developments, 3-D Dimensional (3D) planning has~     evolved as a highly precise treatment planning option. High-precision radiation therapy has~     the potential for more accurate dose delivery to the tumour volume and can result in a~     greater sparing of normal tissue. An important component of safe radiotherapy delivery is the~     feasibility and reproducibility of current and new immobilization devices for highly~     conformal treatment.~      The purpose of this study is to determine the reproducibility of an immobilization device~     known as BodyFIX(TM) using conventional treatment techniques.~   "
253563|NCT00232427|"~     Prospective comparison of standard therapy in liver cirrhosis versus standard therapy plus~     intensified hemodynamic monitoring using the PiCCO system.~   "
253564|NCT00232414|"~     In this study, quetiapine is being tested for the possible treatment of bipolar I disorder~     with an acute depressive episode in children and adolescents.~      We hypothesize that quetiapine will be more efficacious than placebo for the treatment of~     episodes of major depression associated with adolescent BP. Moreover, we hypothesize that~     quetiapine will be safe and well-tolerated compared with placebo for the treatment of~     depression associated with adolescent BP. Based on data from the BOLDER study and other~     studies of atypical antipsychotics in patients with bipolar depression (Calabrese et al.,~     2004, Macfadden et al., 2004, Tohen et al., 2004), which in general reveal effect sizes of~     approximately 0.5, a conservative sample size calculation, assuming power of .8, estimates we~     would need approximately 15 patients in each group to identify a statistically significant~     group difference in our main outcome measure, change form baseline to endpoint in the~     Children's Depression Rating Scale (Poznanski, 1979).~   "
253565|NCT00232401|"~     The purpose of this study is to describe the 24-hour urine output including the urinary~     excretion of hormones, electrolytes and other osmotically active substances in healthy~     children age 0 to 3 years old.~   "
253566|NCT00232388|"~     The purpose of this study is to determine if the carboxy-terminal of procollagen type I~     (PICP) can be a useful marker of different degrees of myocardial fibrosis.~   "
253567|NCT00232375|"~     We tested the hypothesis that insulin therapy rather than sulfonylurea (SU) treatment has a~     preferable outcome to reverse or preserve beta cell function in the patients with diabetes~     that is called slowly progressive insulin-dependent (type 1) diabetes (SPIDDM) or latent~     autoimmune diabetes in adult (LADA).~   "
253568|NCT00232362|"~     This study is being done to determine if pioglitazone (Actos) is helpful to patients with~     type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in~     diabetic patients.~   "
253569|NCT00232349|"~     The purpose of this study was to determine if treatment with adjunctive galantamine is~     effective in the reduction of functional impairments in patients with schizophrenia and~     schizoaffective disorder. It was hypothesized that adjunctive galantamine would yield~     clinically significant improvements from baseline to end of study on a measure of quality of~     life and a measure of independent living skills.~   "
253570|NCT00232336|"~     The purpose of this study was to collect pilot data on whether quetiapine may be effective in~     the reduction of cocaine use and cravings in cocaine dependent individuals.~   "
253571|NCT00232323|"~     The purpose of the study is to check wether training mixed teams of physicians and nurses~     from intensive care units on patient simulators reduces stress in team members.~   "
253572|NCT00232310|"~     Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of~     atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical~     cardioversion.~   "
253573|NCT00232297|"~     Primary objective:~        -  to assess the efficacy of SSR149744C for the prevention of ventricular~          arrhythmia-triggered ICD interventions.~      Secondary objectives:~        -  to assess versus placebo the tolerability of the different dose regimens of SSR149744C~          in the selected population.~        -  to document SSR149744C plasma level during the study.~   "
253574|NCT00232284|"~     This study aims to treat young people with an adjunctive integrated cognitive behavioral~     therapy (CBT) intervention and to examine the acceptability of this treatment approach within~     this population. The study will also include a pilot placebo-controlled trial of sertraline~     for those young people who fail to or only partially respond to the CBT intervention, so as~     to determine whether adjunctive anti-depressant treatment improves clinical response in this~     population.~   "
253575|NCT00232271|"~     The purpose of this study is to assess the effect of the anticoagulant(blood thinner) Clexane~     on the development of leg clots following electrophysiology studies (EPS) and or~     radiofrequency ablation (RFA).~      People who suffer heart palpitations will sometimes need hospital admission to undergo an~     electrophysiology study ( and or a Radiofrequency Ablation)in order to diagnose and or treat~     their condition.~      Radiofrequency ablation is a procedure to stop abnormal heart rhythms. EPS/RFA studies~     require the puncture of the leg veins . Previous experience has shown that following the~     puncture of leg veins there is a small risk of developing a blood clot in the leg.~      It is not known whether giving blood thinners (anticoagulants) after the procedure will~     decrease this risk Enoxaparin Sodium (Clexane) is an anticoagulant used extensively and~     safely following bone (Orthopaedic) surgery to prevent blood clots from developing in the~     legs~   "
253576|NCT00232258|"~     To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic~     mucosal appearance of two doses of SR140333B against placebo in patients with mild to~     moderate ulcerative colitis resistant to treatment with 5-ASA.~   "
253577|NCT00232245|"~     The purpose of this study is to investigate whether fish oil supplements may reduce the~     frequency and duration of paroxysmal atrial fibrillation episodes.~      Atrial fibrillation is a heart condition which effects a large percentage of the population .~      Atrial fibrillation is a condition frequently experienced by people who have had pacemakers~     inserted .~      Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes~     of atrial fibrillation.~      Fish oil supplements may be of benefit to patients with heart problems.Recent evidence~     suggests that fish oils may be beneficial to patients with rhythm disturbances.~      By interrogating pacemakers this study will investigate the effect of fish oil supplements on~     the frequency and duration of episodes of atrial fibrillation.~   "
253578|NCT00232232|"~     The purpose of this study is to investigate whether fish oils may be of benefit to patients~     with certain heart rhythm disturbances called atrial fibrillation and atrial flutter.~      Atrial fibrillation and atrial flutter are two heart conditions that can be successfully~     treated in the hospital by an ablation (in the case of atrial flutter) or a cardioversion (in~     the case of atrial fibrillation). Ablation involves the application of high frequency energy~     waves to a particular spot in the heart. Cardioversion involves resetting the heart back to a~     normal rhythm with the use of an electric current.~      Fish oil supplements may be of benefit to patients with heart problems. Recent evidence~     suggests that fish oils may benefit those with rhythm disturbances.~   "
253579|NCT00232219|"~     The purpose of this study is to investigate whether fish oil supplements may be beneficial in~     preventing the recurrence of atrial fibrillation after cardioversion.~      Atrial fibrillation is a heart condition which can sometimes be successfully treated by a~     cardioversion.~      Cardioversion involves resetting the heart back to normal with the use of electric current.~      There is a tendency for the atrial fibrillation to recur , days weeks or even months after~     the cardioversion.~      Fish oil supplements may be of benefit to patients with heart problems Recent evidence~     suggests that fish oils may be beneficial to patients with rhythm disturbances.~   "
253580|NCT00232206|"~     The primary objective of this study is to assess the response rate of treatment with two~     cycles of cisplatin and docetaxel chemotherapy prior to surgery (neoadjuvant) for early stage~     non-small cell lung cancer (NSCLC). Secondary objectives of this study include assessment of~     radiographic response rate by computed tomography (CT) scanning, overall survival, time to~     progression, rate of complete surgical removal, and adverse reactions. In addition, this~     study will test whether positron emission tomography (PET) imaging can predict a tumor~     response. Patients who have a response to chemotherapy may receive 2 additional cycles after~     recovering from surgery.~   "
253581|NCT00232193|"~     The purpose of the study is to determine whether giving intravenous dexamethasone every 4~     weeks during the first 12 months of weekly Avonex dosing will reduce the progression of~     functional impairment, brain atrophy, relapse rate and frequency, and new and enlarging brain~     lesions over the first 24 months of Avonex therapy in patients with relapsing-remitting or~     mono-symptomatic multiple sclerosis.~   "
253582|NCT00232180|"~     In an earlier study, eplerenone was shown to improve survival in patients who had heart~     failure immediately following a heart attack. However, it is not known how patients with~     established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of~     sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus~     standard heart failure medicines is being compared to placebo plus standard heart failure~     medicines in terms of an additional ability to prolong life and prevent re-hospitalizations~     for worsening heart failure in these patients.~      The Data Safety Monitoring Committee (DSMC) observed during its conduct of the~     protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of~     eplerenone had met the pre-specified stopping rules in the protocol. As a result of the~     discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended~     that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration~     that it would be unethical not to offer this treatment to patients, the ESC recommended that~     all the patients in the trial should be transferred to open-label eplerenone. The Open Label~     Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for~     the indication studied in this patient population.~      On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered~     to be the most appropriate way to ensure that all the subjects who participated in the~     double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone~   "
253583|NCT00232167|"~     The goal of this study is to determine whether indiplon, when administered with sertraline,~     improves insomnia symptoms and depressive symptoms in subjects with both insomnia and~     depression.~   "
253584|NCT00232154|"~     To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg~     tablets for up to 3 days.~   "
253586|NCT00232128|"~     This research trial involves the development of a new treatment for lung tumors. It is for~     patients whose tumor cannot be surgically removed, have refused surgery, or the tumor has not~     responded well to other forms of treatment. This treatment uses a needle probe to deliver~     energy into the lung tumor. This probe is placed utilizing a CT scan image. The energy heats~     the tumor causing tumor cell death.~   "
253587|NCT00232115|"~     An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%,~     in adult patients with perioral dermatitis.~      This study is not enrolling patients in the United States.~   "
253588|NCT00232102|"~     This study is being done to evaluate the long-term safety of tegaserod in women with symptoms~     of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice~     daily.~   "
253589|NCT00232089|"~     This study is being done to evaluate the safety, tolerability and satisfactory relief of~     dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will~     be evaluated at 6mg twice daily and placebo.~   "
253590|NCT00232076|"~     To assess the efficacy and safety of oral OL27-400MEPC 3 mg/kg/day (2-5 mg/kg/day) in 2~     divided doses daily for 8 weeks to patients with severe adult atopic dermatitis.~      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES~   "
253591|NCT00232063|"~     In patients with severe adult atopic dermatitis, the safety and efficacy of OL27-400MEPC will~     be assessed by repeating oral administration at a dose of 3 mg/kg/day (2-5 mg/kg/day) in 2~     divided doses daily for 8-12 weeks and recovery until 52 weeks after starting treatment~   "
253592|NCT00232050|"~     This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult~     patients with moderate to severe bronchial asthma.~   "
253593|NCT00232037|"~     This study is being done to evaluate the long-term safety of tegaserod in women with symptoms~     of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice~     daily.~   "
253594|NCT00232024|"~     This study is being done to evaluate the safety, tolerability and satisfactory relief of~     dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will~     be evaluated at 6mg twice daily and placebo.~   "
253595|NCT00232011|"~     Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent.~     In this study, the long-term safety and efficacy of pimecrolimus cream will be evaluated in~     Japanese adult patients with atopic dermatitis. This study is a 6-month extension study~     following core study.~      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES~   "
253596|NCT00231998|"~     Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent.~     In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in~     Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study~     following core study.~      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES~   "
253597|NCT00231985|"~     This study will compare the efficacy of supportive therapy versus habit-reversal therapy for~     the treatment of Tourette syndrome and chronic tic disorder.~   "
253598|NCT00231972|"~     This study will evaluate the effectiveness of a behavioral intervention program versus~     standard prevention case management in promoting safer sex practices in HIV-infected men.~   "
253599|NCT00231959|"~     This study will evaluate the effectiveness of pramipexole (Mirapex) in managing~     treatment-resistant depression.~   "
253600|NCT00231946|"~     The study is designed to investigate the activity of the hormone drug leuprolide acetate in~     stabilizing cognitive function in mild-to-moderate AD patients.~   "
253601|NCT00231933|"~     This study will compare standard individualized care to person-centered care and~     community-integrating care for treating psychosis in adults of Hispanic or African descent.~   "
253602|NCT00231920|"~     This study proposes to enroll 50 young infants, ages 10 to 22 weeks. Each of the fifty~     infants will receive two 0.25mL doses of preservative-free Fluzone®, given a minimum of 28~     days apart but no more than 42 days apart. Preservative-free Fluzone® will not be~     administered at the same time as other routine vaccines. Approximately 2-3mLs of blood sample~     will be obtained prior to the first vaccination, approximately 4 weeks after the second~     vaccination and 6 months after the second vaccination for the measurement of immune response.~     The primary purpose of this study is twofold: 1.) To determine the safety of administering~     two doses of preservative-free Fluzone® to young infants and 2.) To determine the capability~     of inducing an immune response of administering two doses of preservative-free Fluzone® to~     young infants.~   "
253603|NCT00231907|"~     The purpose of this research is to compare the safety and ability to stimulate antibodies~     (part of the bodies proteins that fight infections) of two influenza (flu) vaccines given to~     children 12 to 35 months old. The two flu vaccines being compared are: trivalent inactivated~     influenza virus vaccine (TIV), a killed virus vaccine given as a shot licensed for use in~     children 6 months of age or older and live attenuated influenza vaccine (LAIV), a live (but~     weakened) virus vaccine licensed for children 5 years old and older given as a nose spray.~     The strains of the viruses have been weakened so that they do not cause typical influenza~     illness, but may allow the body to develop protection against the flu. LAIV vaccine is not~     licensed for children less than five years of age, therefore its use in this study is~     investigational. Participation is approximately 7 months in duration.~   "
253604|NCT00231894|"~     This is a study with an approved drug for treating type 2 diabetes, for its effects on~     treating glucose and lipid abnormalities in patients being treated with first or~     second-generation antipsychotics, and comparison of effects of this drug with another~     treatment lifestyle modification. Patients who meet inclusion criteria will be treated with~     pioglitazone for 12 weeks. They will be evaluated for fasting glucose and lipids,~     glucose-tolerance tests, and neurocognitive battery and tests of verbal memory at baseline~     and during treatment with pioglitazone.~   "
253605|NCT00231881|"~     This study aims to characterize the permeability as well as some protein involved in the cell~     junction in the oesophageal epithelium in patients with GORD symptoms. In addition these~     patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and~     oesophageal acid perfusion test. Correlations between the characteristics of the reflux and~     the biological results will be calculated.~   "
253632|NCT00231530|"~     The purpose of this study is to determine the efficacy and safety of topiramate compared with~     placebo in obese, Type 2 diabetic patients on a controlled diet.~   "
253606|NCT00231868|"~     Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing.~     The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for~     the treatment of UPSC are yet to be established. A retrospective review of 16 patients~     treated at our institution with the sequential use of radiation sandwiched between~     paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a~     median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of~     the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy,~     two of which required a 1 week treatment delay. There were no cases of grade 3 or 4~     thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for~     toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median~     follow up of 15 months, we have not observed late toxicities.~      Given these favorable preliminary findings, supported by recently published data documenting~     efficacy of the sandwich multimodality technique in other difficult uterine malignancies~     (malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and~     radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible~     benefits in progression-free and overall survival.~   "
253607|NCT00231855|"~     The primary aim of this study is:~        -  To determine the overall clinical response rate of weekly Topotecan and Taxotere in~          women with recurrent ovarian, primary peritoneal, endometrial and uterine cancers.~      The secondary aims of this study are:~        -  To evaluate the safety and tolerability of the combination therapy with weekly Topotecan~          and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial or~          uterine cancers.~        -  To determine the progression free survival and overall survival in women treated with~          weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal,~          endometrial and uterine cancers who have been previously treated with chemotherapy~          and/or radiation therapy.~   "
253608|NCT00231842|"~     The optimal sequence and /or modality for adjuvant therapy in the management of MMT clearly~     remains to be established. The rationale for the protocol is to sandwich pelvic radiation~     with chemotherapy to decrease distant metastasis.~      The concept of sequential chemotherapy/radiation therapy/chemotherapy has been previously~     reported. The chemotherapeutic agents employed in that trial were cisplatin and epirubicin~     with a reported survival of 74% in patients with Stage I and II MMT with a median follow-up~     period of 55 months. Toxicity was reported as tolerable and 98% of patients were able to~     complete their therapy. Sequential chemotherapy/radiation/chemotherapy has also been~     investigated in other high risk uterine tumors with a propensity for both distant and local~     recurrence. A retrospective review of 23 patients treated with radiation sandwiched between~     paclitaxel/platinum chemotherapy in patients with uterine papillary serous carcinomas found~     5/23 (22%) to have recurred with a median PFI of 16.6 months (range 12.1 - 23 months). The~     median follow-up was 21 months (range 10-45 months). Of the patients remaining disease-free,~     the median PFI was 21.4 months (range 10-15 months). Toxicity was acceptable and the regimen~     was well tolerated. A prospective trial of this regimen is presently ongoing and without~     unexpected toxicity or morbidity.~      The proposed study will sandwich radiation between the two most active chemotherapeutic~     agents for MMT identified to date (ifosfamide/cisplatin). By doing so, we attempt to decrease~     both local and distant recurrence, which may translate into an improved progression free~     interval and possibly even extend survival.~   "
253609|NCT00231829|"~     Expression of COX-II has been identified in many types of human cancers. Uterine cancer is~     the most common gynecologic cancer in the US and there has been an increase in uterine cancer~     deaths over the past decade mainly due to the difficulty in treating recurrences in the more~     aggressive histologic types. The study co-investigators have also identified COX-II~     expression in grade 2 and 3 endometrioid-type, clear cell, and papillary serous types of~     uterine cancers. Upregulation of COX-II may control the cell cycle by regulating the~     proliferative capacity of neoplastic endometrial cells. This is a Phase II pre-post~     intervention comparison study in eligible patients looking at the effects of a COX-II~     inhibitor on uterine cancer. The patients whose endometrial biopsy shows grade 2 or 3~     endometrioid-type, clear cell, and papillary serous types of uterine cancers will be put on a~     selective COX-II inhibitor, Celebrex (Celecoxib) until the day of their surgery. We~     hypothesize that Celecoxib will downregulate the expression of COX-II in these tumor types as~     it does in other similar tumors. We also hypothesize that apoptosis, as measured with the~     TUNEL assay, will be increased in areas with less COX-II expression and should be inversely~     proportional to cellular p21 expression. We hypothesize COX-related gene expression will be~     altered thus suggesting an up- or down-regulation of these genes in the end-organ tissue.~     Documenting downregulation of COX-II enzyme and altered gene expression in endometrial~     carcinoma after treatment with Celecoxib may result in further prospective studies using~     selective COX-II inhibitors as effective, well-tolerated chemotherapeutic agents in these~     uterine cancers that are resistant to many current therapies.~   "
253610|NCT00231816|"~     The purpose of this study is to determine whether the investigational zoster vaccine has a~     comparable immune response (the body's ability to protect against disease) and safety profile~     when given concomitantly with another vaccine.~   "
253611|NCT00231803|"~     Advanced kidney disease with it's associated heart and blood vessel problems are becoming~     more frequent. These problems markedly affect length and quality of life and cost a lot to~     treat. Treatments are known that can prevent development of advanced kidney and heart~     disease. These treatments are not being optimally applied in the current health system. This~     study aims to identify people with relatively early stage chronic kdiney disease. With the~     participation of these people, the study will test whether a nurse co-ordinated clinic~     involving a medical kidney specialist, applying the known treatments, can reduce or delay the~     onset of advanced kidney disease and heart and blood vessel problems such as heart attack,~     stroke and death, to a greater extent than usual care. The study will also address issues of~     costs associated with care and illness. The nature of the care provided by the heatlh care~     professionals will be studied to see how best to achieve good health outcomes.~   "
253612|NCT00231790|"~     Overactive bladder is very prevalent in postmenopausal women. The current study is designed~     to investigate whether a new drug may offer safe and effective treatment.~   "
253633|NCT00231517|"~     Randomised Double blind placebo controlled cross over design study of the efficacy of~     morphine for inflammatory pain in children with Epidermolysis Bullosa~   "
253613|NCT00231777|"~     A new intravenous medication is being tested for the prevention of the nausea and vomiting~     that occurs after surgery. This new medication is being compared to another intravenous~     medication that is already available to patients for this indication.~   "
253614|NCT00231764|"~     To determine the renal function, as expressed by the glomerular filtration rate at 12 months,~     in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and~     corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine,~     tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving~     standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and~     corticosteroids.~   "
253615|NCT00231751|"~     Existing data support the concept that a genetic predisposition for inhibitor development~     exists. The aim of the Malmö International Brother Study (MIBS) is to evaluate genetic~     factors associated with the development of inhibitory antibodies in patients with hemophilia.~   "
253616|NCT00231738|"~     The purpose of this study was to test the hypothesis that the long-term use of highly (＞98%)~     purified EPA, in addition to HMG-CoA reductase inhibitor (statin), would be more effective~     than statin alone in preventing cardiovascular events in Japanese patients with~     hypercholesterolemia.~   "
253617|NCT00231725|"~     Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home~     situations. Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily~     during the trial.~   "
253618|NCT00231712|"~     The purpose of this study is to conduct an analysis of the influences of~        1. conventional chemotherapy~        2. high-dose chemotherapy followed by autologous stem cell transplant~        3. high-dose chemotherapy followed by allogeneic stem cell transplant on the recovery of~          the immune system.~      Detailed analysis will help to better understand the pathways of recovery of the immune~     system following chemotherapy as well as the pathways of recovery of the immune system~     following autologous or allogeneic stem cell transplantation.~   "
253619|NCT00231699|"~     Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during~     anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing~     general anesthesia is very important. However, there is very little information about~     effectiveness of various insulating materials used in the operating room.~      Objective: To compare the effectiveness of cotton and plastic for prevent intraoperative~     hypothermia in pediatric patients.~   "
253620|NCT00231686|"~     The purpose of this randomized, controlled trial was to determine whether a (and if so which)~     physical conditioning program is effective to improve health status, physical activity, and~     quality of life in patients with cystic fibrosis. A positive effect of physical conditioning~     was expected.~   "
253621|NCT00231673|"~     The purpose of the study is to evaluate the effect of topiramate on clinical and~     electrophysiological parameters in patients with diabetic peripheral polyneuropathy. The~     study will also evaluate the safety of topiramate in this patient population.~   "
253622|NCT00231660|"~     The purpose of this study is to compare the efficacy (in terms of weight and hemoglobin type~     A1c [HbA1c]) and safety of topiramate (96 milligrams[mg] or 192 mg daily) with placebo in the~     treatment of obesity in Type 2 diabetic patients receiving metformin.~   "
253623|NCT00231647|"~     The purpose of this study is to evaluate the effectiveness and safety of a topiramate~     controlled-release formulation in the treatment of obese, type 2 diabetic patients managed~     with diet alone or combined with metformin.~   "
253624|NCT00231634|"~     The purpose of this study is to compare the effectiveness and safety of topiramate with~     placebo in the treatment of obesity and Type 2 diabetes mellitus in patients who have failed~     on sulfonylurea therapy.~   "
253625|NCT00231621|"~     The purpose of this study is to compare the efficacy and safety of daily topiramate versus~     placebo for the treatment of obese subjects with dyslipidemia.~   "
253626|NCT00231608|"~     The purposes of this study are to compare the effects of Topiramate and placebo on abdominal~     visceral fat accumulation at 6 months and to evaluate the safety of Topiramate for up to 12~     months of continued treatment in male patients with abdominal obesity.~   "
253627|NCT00231595|"~     The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate~     (50 milligrams[mg], 100mg, and 200mg per day) compared with placebo in the prevention of~     migraine. The study will also assess the dose response relationship and the efficacy of~     treatment with topiramate versus placebo on Health-Related Quality of Life.~   "
253628|NCT00231582|"~     High-dose chemotherapy (HD-CT) is able to circumvent platinum-resistance of~     resistant/refractory germ-cell tumors (GCTs), but expectancy of cure remains low. New~     strategies are needed with new drugs and a sequential approach.~      Patients with relapsed (but not absolutely refractory to Cisplatinum-based chemotherapy)~     poor-prognosis GCTs are scheduled to receive 2 cycles combining epirubicin and paclitaxel~     followed by 3 consecutive HD-CT supported by stem cell transplantation. One course will~     combine Taxol, 360 mg/m² + thiotepa, 720 mg/m², followed by two ICE regimens (Ifosfamide, 12~     g/m², carboplatin, AUC 20, etoposide, 1500 mg/m²).~      This phase II study is designed as a Gehan method. The main objective of the study is the~     complete response rate. With this aim in view, it is planned to enroll in its first step 14~     patients to insure that if no complete response (CR) is noticed, study would be stopped for~     inefficacy (i.e., a CR rate lower than 20%). If one or more CR are noticed, protocol~     specified that up to 45 patients will be included in order to reduce the confidence interval~     (CI) of the CR rate. Secondary objectives are the overall response rate (RR), the overall~     survival (OS) and the progression-free survival (PFS) rates, toxicity and toxic death rate.~     The statistical analysis is done in terms of intent-to-treat.~   "
253629|NCT00231569|"~     The aim of this study is to assess the safety of varying doses of ISIS 301012 in subjects on~     Stable statin therapy.~   "
253630|NCT00231556|"~     The purpose of this study is to compare the safety and effectiveness of two doses of~     topiramate as monotherapy in the treatment of pediatric and adult patients with newly~     diagnosed or recurrent epilepsy.~   "
253631|NCT00231543|"~     The aim of this trial was to characterise the intra and post operative metabolic, endocrine~     and inflammatory response to laparoscopic fundoplication in children. We are testing the~     hypothesis that laparoscopic fundoplication is associated with a lack of hypermetabolism and~     catabolism and blunting of the endocrine/inflammatory stress response~   "
253634|NCT00231504|"~     The deficit in the total number of antral follicles is associated with a reduction of the~     ovarian fertility potential in young women.~      The principal objective of this study is to evaluate the relationship between FSH receptor~     polymorphism and antral follicle count.~      The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an~     association with a low antral follicle count in the ovary.~   "
253635|NCT00231491|"~     Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This~     condition is often resistant to anticholinergic drugs used as a first line treatment for this~     purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use~     of those treatments. This study is designed to evaluate the efficacy and safety of botulinum~     toxin A injected into the detrusor muscle to control symptoms and improve quality of life for~     patients resistant or intolerant to anticholinergic drugs.~   "
253636|NCT00231478|"~     This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of~     Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be~     randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril~     intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for~     tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is <3 months,~     and the planned sample size was 170 patients.~   "
253637|NCT00231465|"~     This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage~     III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients~     with prior adjuvant chemotherapy were allowed to enroll on this trial.~   "
253638|NCT00231452|"~     The overall objective is to evaluate the effect of exposure to Plasmodium (P.) falciparum~     erythrocytic stage antigens during different periods of infancy on the development of~     naturally acquired immunity (NAI).~      Hypothesis: Exposure to P. falciparum prior to 5 months of age does not result in the~     development of NAI, while exposure to P. falciparum after 5 months of age leads to the~     development of NAI. The risks of clinical malaria and anaemia during the second year of life~     will be compared between cohorts, as well as their correlations with the type and quality of~     immune responses (antibodies to several P. falciparum antigens, cytokines), oxidative stress~     markers and host genetic factors. These results should shed light on the determinants of the~     development of anti-P. falciparum responses early in life and the potential constraints to~     early life immunisation.~   "
253639|NCT00231439|"~     Inflammatory cytokines in the cerebrospinal fluid may contribute to the new muscle weakness,~     fatigue and pain experienced by patients with post-polio syndrome. Intravenousimmunoglobulin~     (IvIg) reduces this inflammation. The purpose of this study is to investigate the clinical~     effect of IvIg in post-polio syndrome.~   "
253640|NCT00231426|"~     The ASSURE Study will evaluate shock conversion performance when programming the first shock~     of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of~     either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration~     conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.~   "
253641|NCT00231413|"~     Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in~     men and women. Several types of HPV infection are transmitted by sexual activity and, in~     women, can infect the cervix (part of the uterus or womb). This infection, if it persists,~     can lead over a long period of time to cancer of the cervix in women. In collaboration with~     MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic~     types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating~     novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a~     novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately~     376 study subjects will receive the novel HPV vaccine or the control vaccine administered~     intramuscularly according to a 0-1-6 month schedule~   "
253642|NCT00231400|"~     The Pompe Registry is an ongoing, international multi-center, strictly observational program~     that tracks the routine clinical outcomes for patients with Pompe disease, irrespective of~     treatment status. No experimental intervention is involved; patients in the Registry undergo~     clinical assessments and receive care as determined by the patient's treating physician.~      The objectives of the Registry are:~        -  To enhance the understanding of the variability, progression, and natural history of the~          key manifestations of Pompe disease;~        -  To assist the Pompe medical community with the development of recommendations for~          monitoring patients and reports on patient outcomes to help optimize patient care;~        -  To characterize and describe the Pompe disease population as a whole; and~        -  To evaluate the long-term effectiveness and safety of available treatment options~          including ERT(Enzyme Replacement Therapy) with Myozyme®.~   "
253643|NCT00231387|"~     This is a phase IIIb, randomised, double blind, placebo controlled, study in patients with~     type 2 diabetes mellitus and coexisting vascular disease or hypertension. The total duration~     of the study will be approximately 60 weeks. The aim of this study is to examine the~     potential beneficial effects of rosiglitazone on carotid atheroma in patients with type 2~     diabetes mellitus and coexisting vascular disease or hypertension. It is hypothesised that~     treatment with rosiglitazone will lead to an decrease in plaque size. In addition, it is~     hoped that rosiglitazone will have a positive effect on plaque composition and stability.~   "
253644|NCT00231374|"~     This is a study looking at pressure changes in the fluid that surrounds the spine when a~     person is positioned in 2-3 different ways.~   "
253645|NCT00231348|"~     The purpose of this study is to determine the effectiveness of nefazadone in patients with~     social anxiety disorder (SAD).~   "
253646|NCT00231335|"~     A primary hypothesis to be explored here is that, given its pharmacodynamic profile and~     hypothesized mechanisms associated with schizophrenia, escitalopram will, in comparison to~     placebo, be effective when added to risperidone or olanzapine treated group in reducing the~     severity of resistant symptoms, particularly existing subsyndromal anxiety and depression.~   "
253647|NCT00231322|"~     To assess the influence of seasonal variations in Schistosoma haematobium transmission on~     treatment outcome (morbidity and re-infection)~   "
253681|NCT00230854|"~     The purpose of this study is to assess the safety and efficacy of repeated intravenous~     infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with~     chronic hepatitis C genotype 1.~   "
253648|NCT00231309|"~     The major purpose of this study is to evaluate the curative potential of white cell growth~     hormone (G-CSF)-stimulated bone marrow cells in allogeneic bone marrow transplants. Patients~     with cancers or blood diseases, who have poor potential for a cure with standard treatment,~     will be able to participate in the study. Donors will receive the white cell growth hormone~     (G-CSF) as a shot (injection) in their arm once a day for three days before they donate their~     bone marrow cells. Total body irradiation and/or chemotherapy will be given first to prepare~     the patient's body for the infusion of new bone marrow cells from the donor. Two medicines~     (cyclosporine and methotrexate) will be used to prevent the new bone marrow cells (graft)~     from attacking the patient's body (host) (graft-versus-host disease; GVHD). Certain safety~     checkpoints were built into the study if unwanted/unexpected events were to occur. If the~     outcomes appear better than could be expected, this will provide a bridge to extend this~     current approach for other innovative therapies.~   "
253649|NCT00231296|"~     A multi-center, randomized, controlled study of cryoablation vs medical management for the~     treatment of PAF~   "
253650|NCT00231283|"~     The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT~     Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System~     (SDS) in patients with de novo native coronary artery lesions.~   "
253651|NCT00231270|"~     The primary objective of this study is to compare the safety and effectiveness of the Cordis~     Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal~     protective device to CEA in the treatment of carotid artery disease in patients at increased~     risk for surgery.~   "
253652|NCT00231257|"~     The main objective of this study is to demonstrate the superiority or non-inferiority of the~     sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with~     in-stent restenotic native coronary artery lesions.~   "
253653|NCT00231244|"~     The objective of this study is to allow treatment with the sirolimus-eluting Bx VELOCITYTM~     stent in patients with a serious disease or condition for which there is no generally~     acceptable alternate treatment available.~   "
253654|NCT00231231|"~     The primary objective of this study is to assess the outcomes of stenting with distal~     protection in the treatment of obstructive carotid artery disease during~     peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical~     Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis~     ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).~   "
253655|NCT00231218|"~     We hypothesize the herbal preparation will enhance the preschoolers' immune response and when~     taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections~     and gastroenteritis in the active versus the control group.~   "
253656|NCT00231205|"~     The purpose of the study is to test accuracy of positive preejection velocity to predict left~     ventricular remodeling and long-term prognosis after revascularization in 200 patients with~     chronically dysfunctional myocardium. Patients will be followed for 3 years.~      Our hypothesis is that tissue-Doppler-derived analysis of positive preejection velocity~     allows to select optimal responders to revascularization; it means individuals with the~     greatest benefit in terms of LV remodeling and long-term prognosis.~   "
253657|NCT00231192|"~     This study will test the hypothesis that oral repaglinide is equivalent to insulin in the~     treatment of new-onset CFRD in adolescents. In addition, successful treatment of CFRD with~     repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and~     will not have a negative impact upon quality of life.~   "
253658|NCT00231179|"~     The purpose of the MOM Program Continuation is to promote child development by helping~     families become more competent in accessing and using available health, developmental and~     educational resources. The program focuses are childhood immunizations, Early Intervention~     services, lead screening, Early Head Start and Head Start enrollment. The Intervention~     consists of frequent phone calls and home visits to encourage mothers to have their babies~     immunized on schedule and to participate in needed developmental and educational services.~     The program seeks to fill the gap between children's need for services and mothers' ability~     to assure their children's participation in those services.~   "
253659|NCT00231166|"~     The purpose of this study is to determine the highest tolerated dose, safety and activity of~     HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.~   "
253660|NCT00231153|"~     The purpose of this study is to determine whether treatment with topical omiganan is more~     effective than treatment with topical povidone-iodine in preventing local catheter site~     infections and catheter colonization in patients who have central venous catheters.~   "
253661|NCT00231140|"~     Neuroinflammation has recently emerged as a significant contributor to motor neuron damage.~     ALS tissue is characterized by inflammatory changes that are observed in both sporadic and~     familial ALS and in the ALS superoxide dismutase 1 (SOD1) transgenic mouse model. They~     include an accumulation of large numbers of activated microglia and astrocytes.~      Proinflammatory cytokines, such as tumor necrosis factor (TNF-), are robustly upregulated in~     ALS. The receptor for tumor necrosis factor- (TNF-R1) is elevated at late presymptomatic as~     well as symptomatic phases of disease. TNF acts as a principal driver for neuroinflammation~     in ALS, while several co-stimulating cytokines and chemokines act to potentiate the TNF~     effects [4-6].~      We propose an investigational therapy of ALS with oral administration of thalidomide. The~     rationale for this study is based on the anti-inflammatory properties of thalidomide through~     the modulation of inflammatory cytokines such as TNF. The primary aim of the trial is to~     determine whether treatment with thalidomide is safe and well tolerated in conjunction with~     riluzole and whether patients with ALS can tolerate daily doses of up to 400 mg. The trial is~     designed as feasibility study in planning for a larger phase IIb/III trial of efficacy.~   "
253662|NCT00231127|"~     The goals of the trial are:~        -  To determine the prevalence of osteoporosis in subgroups of COPD patients.~        -  To look for risk factors of osteoporosis in COPD patients.~        -  To create sub-groups for prospective research concerning the effects of bisphosphonates~          on osteoporosis variables in COPD patients.~   "
253723|NCT00230308|"~     Through this study, we hope to learn more about the mechanisms, which may contribute to~     development and progression of head and neck cancer. The long-term goal of this study will be~     to develop new strategies and drugs for the diagnosis and treatment of head and neck cancer.~   "
253663|NCT00231114|"~     The objective of this randomized, double blind, sham-controlled study is to demonstrate the~     safety and effectiveness of the Alair System in a population of subjects with severe asthma~     who are still symptomatic despite being managed on conventional therapy of high doses of~     inhaled corticosteroids and long-acting β2-agonists.~      The primary efficacy endpoint will be the difference between Study groups in the change in~     Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from~     the 6-, 9-, and 12-month follow-up visits.~      All other outcome measures assessed at 12 months post-treatment.~      This will be a multicenter, randomized, double-blind, sham-controlled study comparing the~     effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids~     (ICS) and long-acting β2-agonists (LABA).~      A Bayesian adaptive approach to sample size selection is used with a randomization scheme of~     2:1 (two Alair Group Subjects for every one Control Group Subject).~   "
253664|NCT00231101|"~     A single-blind switching study in which forty subjects currently being treated with~     risperidone will be randomly assigned to either stay on risperidone or switched to~     quetiapine. Various behavioral and biological measures will be used to compare smoking~     behavior over time in these two groups.~   "
253665|NCT00231075|"~     Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older~     with epithelial ovary cancer F.I.G.O. stages III and IV.~   "
253666|NCT00231062|"~     A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal~     sinuses.~   "
253667|NCT00231049|"~     This is a randomized, multi-center, sequential, dose-escalating study of three dose cohorts~     of AG-707. Individuals who meet all of the inclusion and exclusion criteria for eligibility~     will be randomized to receive either AG-707 (at the 80 µg dose), AG-707 with QS-21 (at the 80~     µg dose), placebo, or QS-21. Each patient will be monitored for safety as specified in the~     protocol.~   "
253668|NCT00231023|"~     This study will evaluate which of the three following treatment options is better for~     diabetic macular edema: laser alone, steroid injection alone, or steroid injection followed~     by laser. Macular edema is a swelling in the small central part of the retina - the part of~     the retina that is used for sharp, straight-ahead vision. Laser treatment is the only~     treatment that has been proven to be beneficial for diabetic macular edema. It reduces the~     swelling and lessens the chance of further vision loss, but it does not improve vision.~     Triamcinolone is a steroid drug that decreases inflammation and scarring. Injections of the~     drug have decreased macular edema in some patients and improved vision. Swelling may return,~     requiring repeat injections, and it is not known if the vision improvement is permanent. This~     3-year study will examine and compare the benefits and side effects of both treatments, alone~     and in combination.~      Patients 18 years of age and older with diabetic macular edema may be eligible for this~     study. Participants undergo the following tests and procedures.~      At the beginning of the study:~        -  Blood tests to measure HbA1C (measure of diabetes control).~        -  Measurement of blood pressure.~        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to~          examine pupils, lens, retina and eye movements. The pupils are dilated with drops for~          this examination.~        -  Optical coherence tomography (OCT) to measure retinal thickness. This test shines a~          light into the eye and produces cross-sectional pictures of the retina. These~          measurements are repeated during the study to determine if retinal thickening is getting~          better or worse, or staying the same.~      Photographs of the retina and lens. A special camera with bright flashes is used to take~     these photographs.~      Treatments~      Some patients will have one eye treated and some patients will have both eyes treated. The~     treatment for a given individual is determined by chance:~        -  Triamcinolone acetonide injection alone. The steroid is injected in the tissue around~          the eye. Two injection procedures are used in the study, differing in their location and~          dose. Numbing drops are placed over the area to be injected and the steroid is injected.~        -  Laser treatment alone. The surface of the eye is numbed with drops and a contact lens is~          placed on the eye during the laser beam application. Before the treatment, patients may~          have fluorescein angiography, in which pictures of the retina are taken using a yellow~          dye. The dye is injected into a vein and travels to the blood vessels in the eye. The~          camera flashes a blue light in the eye and takes pictures that show the amount of dye~          leakage into the retina. Treatments may be repeated at several visits.~        -  Triamcinolone acetonide plus laser treatment. Patients who receive both the steroid~          injection and laser have the steroid injection first and the laser treatment 1 month~          later.~      Follow-up~      Patients return to the clinic for follow-up visits at 1, 2, 4, 8, 12, 24 and 36 months, or~     more often if needed, after the initial treatment for an eye exam, measurement of visual~     acuity, and OTC. Photographs of the retina are taken at the 4- and 8-month visits and at the~     1-, 2- and 3-year visits. Fluorescein angiography may be done at 4 months. Blood pressure is~     measured at the 1-, 2- and 3-year visits, and an HbA1c blood test is done at 4 and 8 months~     and at the yearly visits. Participants may be asked to complete a questionnaire once a year~     about their vision and medical condition. Treatment options are discussed at the 4- and~     8-month visits.~   "
253669|NCT00231010|"~     This multinational study will investigate the inheritance of genetic retinal degeneration in~     families of different nationalities and ethnic backgrounds in order to identify the genes~     that, when altered, cause retinal degeneration. The retina is a light-sensitive membrane~     lining the back part of the eye. It relays vision signals to the brain, which the brain~     interprets into sight. When the retina degenerates, vision is altered and possibly lost. The~     findings of this study should help improve diagnosis and methods of treatment for these~     disorders. Participating institutions include: the National Institutes for Health in~     Bethesda, Maryland; the University of Miami in Florida; the Casey Eye Institute in Portland,~     Oregon; the Byrd Health Sciences Center in Morgantown, West Virginia; the University of Texas~     Southwestern Medical School in Dallas, Texas; the University of Tennessee Health Sciences~     Center in Memphis; the Prasad Eye Institute in Hyderabad, India; National Center of~     Excellence in Molecular Biology in Lahore, Pakistan; and the Jules Gonin Hospital in~     Lausanne, Switzerland.~      Patients with retinitis pigmentosa and closely related diseases such as Usher syndrome,~     snowflake vitreoretinal dystrophy and Bietti crystalline dystrophy may be eligible for this~     study. Participants undergo the following tests and procedures:~        -  Medical and surgical history, including family history of vision problems.~        -  Examination to clarify the type of retinal degeneration.~        -  Eye examination, including tests of color vision, field of vision and ability to see in~          the dark~        -  Electroretinogram to test the function of visual cells. For this test, the patient sits~          in a dark room for 30 minutes with his or her eyes patched. Then, a small electrode~          (silver disk) is taped to the forehead and the eye patches are removed. The surface the~          eyes is numbed with eye drops, and contact lenses are placed on the eyes. The patient~          looks inside a large dark globe that emits a series of light flashes. Then a light is~          turned on inside the globe and more lights flash. The contact lenses sense small~          electrical signals generated by the retina when the light flashes.~        -  Hearing tests for patients with a personal or family history of deafness. Tests include~          an audiogram, ear examination and test of middle ear function. For middle ear function~          testing, the patient feels a little air pressure change for a moment and hears some~          tones. Another test requires the patient to sit quietly with electrodes on the head,~          forehead and earlobes.~        -  Balance testing, including walking in a straight line, standing with eyes closed in the~          dark and other tests of coordination, and caloric testing. For the caloric testing, any~          ear wax in the ear canal is removed before the test begins. Then, electrodes are placed~          on the skin near the eyes and on the forehead. A small amount of cool (sometimes cold)~          or warm water is instilled into each ear canal, first one and then the other.~        -  Blood sample collection for genetic testing.~   "
253670|NCT00230997|"~     TRIAL SUMMARY:~      This is an open-label, 24-week, investigator initiated study to evaluate the safety and~     efficacy of galantamine (16 8 to 24 mg/day; flexible dosing) in the treatment of Dementia~     with Lewy bodies. The primary efficacy variables will be the NPI -12, the COGDRAS tests of~     attention and visuospatial orientation, and the ADCS-CGIC. The secondary efficacy variables~     will be the MMSE, ADCS-ADL-Inventory, ADAS-Cog, PSQI, and the use of concomitant rescue~     antipsychotic medication. PET scanning will be obtained on 10 patients at one site. An~     interim analysis will also be performed. Safety outcome measures will be adverse event~     reports, vital signs, physical examinations, ECG, laboratory parameters and the UPDRS (motor~     subscale).~   "
253671|NCT00230984|"~     Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure~     and nutritional depletion.~      This is a randomized controlled, open clinical trial with two groups.~        -  first group, 100 patients : control group, patients followed with no add-on intervention~        -  Second group, 100 patients : rehabilitation group with education, oral supplements,~          exercise and androgenic steroids.~   "
253672|NCT00230971|"~     This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus~     metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy~     through the test-of-cure assessment. Safety evaluations will occur through the treatment and~     post-treatment periods and continue through resolution or stability of the adverse event(s).~   "
253673|NCT00230958|"~     This purpose of this study is to determine the safety and effectiveness of viramidine to~     ribavirin in chronic hepatitis C patients who have never before recieved treatment.~   "
253674|NCT00230945|"~     The purpose of this study is to determine if osteoarthritis patients and their spouses~     experience greater health benefits from a couples-oriented psychosocial intervention than a~     patient-oriented psychosocial intervention, and to determine if each intervention is more~     beneficial than patient usual medical care.~   "
253675|NCT00230932|"~     Our purpose is to evaluate the reliability and validity of the '5th vital sign' in everyday~     practice settings and to compare the relationship of pain to other symptoms and pain~     treatment in patients with cancer, CHF, and patients with complex general medical illness and~     poor self-reported health.~   "
253676|NCT00230919|"~     Overweight and obesity is increasing in most countries, including Norway, and the optimal~     diet for reducing weight is under discussion. The present study in overweight and moderate~     obese individuals compares a low glycemic load diet with a standard low-fat diet (as~     recommended from the National Nutrition Council) in an open, randomized trial over 12 months,~     with changes in weight loss and changes in cardiovascular risk markers as endpoints.~   "
253677|NCT00230906|"~     Comparison of the uremic toxin removal by haemodialysis either with a low flux or a new high~     flux cellulose triacetate membrane~   "
253678|NCT00230893|"~     The primary objective is to examine the percentage of patients with PTSD who were prescribed~     an antipsychotic over the past seven years in the VA Network 7 (AL, GA, SC) and compare the~     percentage on an annual basis. We will also determine the type and dose of antipsychotics~     received. We hypothesize that there has been a significant increase in antipsychotic use,~     especially atypical antipsychotics, prescribed for patients with PTSD over the last 7 years~   "
253679|NCT00230880|"~     The New Generation Health Center/University of California, San Francisco (UCSF) will~     implement an intervention to impact contraceptive behavior and reduce unintended pregnancy~     and sexually transmitted infections (STIs) among adolescent females who receive services at~     the New Generation Health Center (NGHC)/UCSF in San Francisco. Study subjects will be~     randomized into either standard reproductive health services or standard services plus~     follow-up motivational counseling telephone calls. Outcomes will be evaluated by ETR~     (Education, Training, Research)Associates, who will conduct follow-up surveys with all study~     participants at baseline, 6 months, 12 months and 18 months.~   "
253680|NCT00230867|"~     Currently approved drugs for the treatment of herpes labialis (cold sores) exhibit low levels~     of efficacy due to the limited ability of the drugs to penetrate the skin to the site where~     the herpes virus is replicating. Iontophoresis uses electric current to enhance the delivery~     of drugs through the skin. This trial is testing a new iontophoretic device for the delivery~     of acyclovir cream to treat cold sores.~   "
253682|NCT00230841|"~     Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency~     Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered~     is humidification which can liquify airway secretions and decrease airway swelling. This~     study will compare the effectivenesss of 40% and 100% humidity through a specially designed~     machine called a nebulizer, with the usual humidity set-up (blown into the patient's face~     from a hose).~   "
253683|NCT00230828|"~     Patient-reported health economic outcomes for patients enrolled in S1543003 and S1543004~     protocols~   "
253684|NCT00230815|"~     This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and~     efficacy with follitropin alfa injection applied by Pen device compared with the subject's~     previous experience with injectable gonadotropins in oligoanovulatory infertile women~     undergoing ovulation induction~   "
253685|NCT00230802|"~     Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose~     adjustment recommendations to be made at the first confirmation of pregnancy in women with a~     history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism~     who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon~     confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid~     hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every~     two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints~     will be the proportion of women in each group who remain euthyroid throughout the first~     trimester and throughout pregnancy.~   "
253686|NCT00230789|"~     To evaluate the effect of tolterodine ER in conjunction with behavioral intervention on~     subject satisfaction in OAB subjects who were dissatisfied with their most recent~     antimuscarinic OAB medication therapy.~   "
253687|NCT00230776|"~     To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of~     pain associated with fibromyalgia and improvement of function of patients with fibromyalgia~   "
253688|NCT00230763|"~     To determine the predictive factors of a positive response to latanoprost 0.005% / timolol~     0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of~     treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT,~     concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal~     thickness, compliance, and adverse events).~   "
253689|NCT00230750|"~     The purpose of this research study is to compare how the body reacts to different strengths~     of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after~     subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males~     and females, aged 65 and older. The vaccine is given as an injection or shot in the arm.~     Subjects will receive 3 doses of vaccine at Day 0, Month 1 and Month 6. There are 2 different~     doses of the new H5N1 vaccine that will be given in this study. There is also a chance that a~     subject may receive a placebo (dummy) injection of saltwater instead of the flu vaccine.~     Study procedures will include physical exams and blood sample collections. Additionally,~     participants will complete a memory aid card to document daily temperatures and any symptoms~     experienced for a week after receiving vaccine. The length of participation in this study~     will be approximately 14 months.~   "
253690|NCT00230737|"~     This study will determine whether melatonin tablets will increase the sleep of older adults~     with insomnia.~   "
253691|NCT00230724|"~     Maintaining exercise participation among patients who have completed cardiac rehabilitation~     is integral to secondary prevention of coronary events and cardiac re-hospitalization. To~     promote exercise maintenance after completion of a 12 week Phase II rehabilitation program,~     we propose to offer a theoretically-based intervention that we have used successfully to~     promote exercise among older, primary-care patients. This program (Maintenance Counseling)~     includes brief advice from the Cardiac Rehabilitation case manager at Phase II program~     discharge followed by telephone-counseling based on the Transtheoretical Model of Behavior~     Change and Social Cognitive Theory. Health educators will provide the telephone-based~     intervention over 6 months. Using a randomized controlled design, 180 patients will be~     assigned to Maintenance Counseling or Brief Advice plus Contact Control. Outcome assessments~     will include an exercise tolerance test (baseline/post-rehabilitation and 6 months),~     self-reported exercise participation, motivational readiness for exercise, and objective~     activity monitoring at baseline, 6, 12 and 18 months.~   "
253692|NCT00230711|"~     This study aims at testing the efficacy of a physical activity (PA)intervention in an~     outpatient oncology setting. We plan to compare Brief Advice for PA (MD advice plus contact~     control) vs. Extended Advice (MD advice plus telephone-based PA counseling by research staff)~     over 3 months among 300 women who have completed treatment for breast cancer in the past 2~     years.~      Specific Aims: The primary aim is to examine the effects of oncologists' advice on PA plus~     telephone counseling (Extended Advice) vs. oncologists' advice (Brief Advice) alone on~     minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed~     treatment for breast cancer.~      Secondary aims include examining a) the effects of the two interventions on participants'~     moderate-intensity PA at 6 and 12 months, b) the effects of the interventions on~     participants' physical functioning, fatigue, vigor and quality of life (QOL) at 3, 6 and 12~     months, and c) the acceptability of the interventions to the oncologists and the usefulness~     of the interventions to patients.~   "
253693|NCT00230698|"~     The purposes of this study are (1) to compare the effectiveness of two doses of topiramate~     and (2) to assess the safety of topiramate alone in the treatment of pediatric and adult~     patients with recently diagnosed epilepsy characterized by partial-onset seizures.~   "
253694|NCT00230685|"~     The Hammersmith Hospital provides a clinical service for patients with Hereditary~     haemorrhagic telangiectasia and pulmonary arteriovenous malformations that is unique in the~     United Kingdom. Measurements obtained as part of standard clinical practice that has evolved~     since 1985 allow us to assess whether particular groups of individuals that we see are more~     prone to recognised complications such as strokes, brain abscesses, pregnancy related~     complications or pulmonary hypertension. We hypothesise that certain clinical characteristics~     will predict the susceptibility of individuals to particular complications.~   "
253724|NCT00230295|"~     To determine the ability of magnetic resonance lymphangiography using conventional gadolinium~     injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis~     in patients with newly diagnosed H&N cancers~   "
253695|NCT00230672|"~     Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an~     disease that leads to the development of dilated and fragile blood vessels, including~     arteriovenous malformations in the lungs (PAVMs). We hypothesize that the~     genetically-determined abnormality in the blood vessels of HHT patients leads to alteration~     in the concentrations or activity of several proteins in the blood stream. We propose to take~     blood samples from patients at defined times in order to study changes in blood protein~     levels and activity~   "
253696|NCT00230659|"~     The inherited disease hereditary haemorrhagic telangiectasia (HHT) causes bleeding from~     dilated fragile vessels, particularly in the nose and gut. However, many HHT patients develop~     deep venous thromboses and/or pulmonary embolism, necessitating treatments with~     anticoagulants that further impair control of their haemorrhagic state. Our initial~     observations using general coagulation tests suggest that the blood of HHT patients is~     intrinsically hypercoagulable.~      We hypothesize that the genetically-determined abnormality in the blood vessels of HHT~     patients leads to alteration in the concentrations or activity of one or several of the~     proteins which affect blood clotting leading to a hypercoagulable state.~      We propose to study levels and activity of blood coagulation factors in people with~     hereditary haemorrhagic telangiectasia and in normal volunteers. This should define the~     significance and basis for our initial observations, and will have significant implications~     for the clinical management of HHT patients.~   "
253697|NCT00230646|"~     Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a~     favorable prognosis. Colorectal cancer survivors report increased fatigue, low vigor,~     impaired physical functioning and disturbances in body esteem. However, the group is~     relatively understudied and the potential benefits of increased physical activity to their~     recovery have not been examined. This study focuses on enhancing recovery by offering a~     home-based physical activity program to patients who have completed treatment for colorectal~     cancer. This study will test the efficacy of the physical activity intervention using a~     randomized controlled design among 134 patients who have completed treatment for colorectal~     cancer in the past 2 years. Outcomes will include physical activity behavior, fitness, vigor,~     fatigue, physical functioning, and body esteem among participants at baseline, 3~     (posttreatment), 6 and 12 months. We will also track intervention costs and conduct~     exploratory analyses of moderators and mediators of change to help guide the future~     development of physical activity interventions to enhance recovery from colorectal cancer.~   "
253698|NCT00230633|"~     Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an~     disease that leads to the development of dilated and fragile blood vessels. We propose to~     take blood samples from patients with HHT, and culture white blood cells that express the~     proteins mutated in HHT, namely endoglin and ALK-1. We will study the properties of these~     cells which will involve their growth in media prompting different types of differentiation,~     or infection of cell lines with Epstein Barr virus to provide cell lines which can be~     repeatedly studied. It is anticipated that DNA, mRNA and proteins will be extracted from~     these cells for study of white cell responses and association with expression levels of~     endoglin and ALK-1 We hypothesize that these cells which express half-normal endoglin or~     ALK-1 will show altered protein synthetic differences when compared to normal white blood~     cells. We anticipate that that these findings may help to explain aspects of the HHT disease~     phenotype.~   "
253699|NCT00230620|"~     Hereditary haemorrhagic telangiectasia is a disease inherited as an autosomal dominant~     disease. Analysing DNA from affected and unaffected family members allows us to identify the~     location of disease genes by linkage analysis. Sequencing genes in the interval identified by~     linkage analysis allows us to identify which precise gene is mutated. Further functional~     studies can then determine why the mutations in that gene cause the disease.~   "
253700|NCT00230607|"~     The study will last for up to 2 years (24 months). Full participation for both mother and~     infant is 24 months, full participation of mother and development of infant is 24 months,~     while full participation of mother and no infant participation is 6 months~   "
253701|NCT00230594|"~     The purpose of this study is to determine whether desmopressin administered as a melt tablet~     is effective in reducing the number of wet nights in children and adolescents who suffer from~     bedwetting.~   "
253702|NCT00230581|"~     In this study, female patients with IBS-d will be treated for 8 weeks to assess the safety~     and effectiveness of DDP225 on GI transit and in reducing IBS symptoms.~   "
253703|NCT00230568|"~     12-week, open-label study to evaluate the effectiveness and safety of donepezil hydrochloride~     in Hispanic patients with mild to moderate Alzheimer's Disease (AD) in the U.S.~   "
253704|NCT00230555|"~     The purpose of the MOM Program is to promote child development by helping families become~     more competent in accessing and using available resources. The program focuses are childhood~     immunizations, Early Intervention services, lead screening, Early Head Start and Head Start~     enrollment. The hypothsis is that children receiving the intervention will participate in~     more of the public services and primary healthcare activities which have been shown to be~     effective in improving their development.~   "
253705|NCT00230542|"~     The purpose of this study is to determine the effects (good and bad) the combination of~     carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian~     tube cancer.~   "
253706|NCT00230529|"~     The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade)~     in patients with plaque-type psoriasis.~   "
253707|NCT00230516|"~     This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers~     better intragastric acid suppression than iv lansoprazole (Prevacid ®~   "
253708|NCT00230503|"~     -  Compare the safety of four oral doses of pradefovir after 48 weeks of treatment~        -  Select the dose of pradefovir for Phase 3 studies~   "
253709|NCT00230490|"~     Compare the long-term safety of pradefovir to adefovir dipivoxyl~   "
253725|NCT00230282|"~     The primary objective of this study was to evaluate the safety and efficacy of the~     combination of fludarabine and cyclophosphamide in previously untreated CLL patients.~     Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day~     cycles.~   "
253737|NCT00230126|"~     This study determines tumor response rate, time to tumor progression and survival rate at 1~     year produced by OSI-774 in previously treated African American patients with nonsmall cell~     lung cancer.~   "
253710|NCT00230477|"~     This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine~     combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil~     and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic~     hepatitis B.~      The primary hypothesis is that subjects treated with combination therapy will see their viral~     DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary~     hypothesis is that subjects treated with combination therapy will have a higher HBeAg~     conversion rate compared to historical controls of subjects treated with lamivudine or~     adefovir dipivoxil monotherapy.~   "
253711|NCT00230464|"~     Incretin hormones (GIP and GLP-1) stimulate insulin release in a glucose dependant manner,~     hence are necessary for maintenance of normal glucose tolerance. Both GIP and GLP-1 are~     degraded and inactivated by DPP-4.~      LAF 237 is an inhibitor of DPP-4 that has been shown to increase meal-stimulated levels of~     intact GLP-1 in animals and patients with T2DM..~      The purpose of the current study is to explore the acute effects of LAF237 on the rate of~     appearance and disappearance of glucose in type 2 diabetics. Secondary objectives include the~     effect on FPG, insulin secretion rates, glucagon and FFA levels, and rate of glucose entry~     from the GI tract.~   "
253712|NCT00230451|"~     Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer~     of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation~     therapy may add benefit. The purpose of this study is to determine if a treatment program of~     combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery~     will delay or eliminate recurrence of the cancer.~   "
253713|NCT00230438|"~     Delivery of conformal radiation therapy following radical prostatectomy is limited by the~     inability to define the clinical target volume (CTV). This stems from a poor understanding of~     patterns of local recurrence and limitations of standard imaging techniques.Magnetic~     Resonance Imaging (MRI) is a promising modality for imaging the prostatic bed following~     radical prostatectomy. MRI provides more detailed postoperative anatomy to guide CTV~     delineation, the ability to document local recurrence patterns, and a method to assess~     intrafraction prostatic bed motion and deformity to define appropriate planning target volume~     margins. The aim of this pilot study is to develop a technique for external beam radiation~     therapy (EBRT) following radical prostatectomy based on MRI-delineation of the CTV. Twenty~     patients will be enrolled in this pilot, development phase.~   "
253714|NCT00230425|"~     The purpose of this study is to measure daily mood changes and to find out whether these mood~     changes are related to the ability to maintain attention on a task. Problems with mood are~     more common among women however, the association between symptoms of alcohol abuse and mood~     syndromes is inconsistent.~      First we hypothesize that women with lifetime diagnoses of alcohol abuse will not demonstrate~     higher symptoms of anxiety, depression, neuroticism and mood variability than control groups.~     Second, that the severity of these symptoms will not correlate with performance on measures~     of sustained attention.~   "
253715|NCT00230412|"~     The purpose of the investigators' study is to determine whether the production of heat shock~     proteins has an effect on the development and the outcome of acute renal failure in children.~   "
253716|NCT00230399|"~     This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan,~     for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually,~     are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The~     combination of these two drugs is experimental (not approved by the FDA as standard~     treatment), but is a widely used treatment option and preliminary studies have shown that~     treatment with the combination of capecitabine and irinotecan has a positive effect on~     metastatic colorectal cancer. Likewise, previous research in animals has shown that~     celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type~     and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.~   "
253717|NCT00230386|"~     This is a pilot study of 50 patients to establish whether there is a potential role for MRI~     perfusion in the detection of locally recurrent or persistent prostate carcinoma after~     previous treatment with radiotherapy. All subjects will be patients who have had localised~     prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the~     prostate to look at local control within the prostate as part of their management. The~     objective of the study is to establish whether there is a relationship between recurrent or~     persistent disease within the prostate and increased perfusion on MRI at these sites.~   "
253718|NCT00230373|"~     Localized scleroderma or morphea is a fibrotic disease, imiquimod induces cytokines which~     inhibit fibrotic activity . We propose that topical imiquimod 5% cream is efficacious and~     safe in treating plaque-type morphea. Twenty adults will be enrolled for a pilot study. A~     screening and baseline clinic visit will be required for each patient enrolled in the study.~     Each visit will involve completing a medical history, skin examination, digital pictures,~     histologic examination if the patient consents and an ultrasonographic score. One morphea~     plaque will be treated with topical imiquimod 5% cream, and another morphea lesion with~     vehicle cream. Patients will be asked about side effects (local and systemic). Patients will~     be followed up in the clinic at 3, 6 and 9 months of therapy, and 3 months following end of~     treatment period (month 12).~   "
253719|NCT00230360|"~     Purpose To compare different kinds of diagnostic investigations in order to identify the most~     sensitive and least invasive when diagnosing constipation.~   "
253720|NCT00230347|"~     This study is intended to establish the practicality of treating cancer in the liver with~     precisely administered single fractions of high-energy radiation using a radiosurgical~     (cross-firing) technique. A second purpose is to establish a safe dose for such therapy.~     Finally, the efficacy of radiosurgical ablation of liver tumors, in terms of radiographic~     response, will be measured.~   "
253721|NCT00230334|"~     The purpose of the trial is to determine the safety and efficacy of Gleevec in idiopathic~     hypereosinophilic syndrome (HES) and to characterize the molecular basis for the therapeutic~     benefit of Gleevec in HES.~   "
253722|NCT00230321|"~     The primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as~     determined by changes in hemoglobin and/or red blood cell (RBC) transfusion-dependence and to~     describe the safety profile of darbepoetin alfa in patients with MDS. The secondary objective~     is to assess bone marrow progenitor BFU-E growth before and after treatment with darbepoetin~     alfa.~   "
253726|NCT00230269|"~     In patients with cancer of the head and neck and rectum, knowing the exact location of the~     tumor is important for designing the radiation field to ensure delivery of high dose of~     radiation to the tumor while sparing surrounding normal tissues. A new medical imaging method~     which is a combination of positron emission tomography (PET) and computed tomography (CT)~     scan, has shown promise in helping the radiation oncologist in defining the exact location~     and extent of the tumor in certain cancers such as lung cancers. Therefore the purpose of~     this study is to determine if these imaging methods can be used in combination with the~     standard radiation treatment planning procedure to improve the accuracy to targeting your~     tumor with radiation. In addition the PET-CT scan, similar to the PET scan alone with better~     resolution, can be used to determine whether the tumor has spread to any part of the body~     outside of the head and neck sites.~   "
253727|NCT00230256|"~     The purpose of the research study is to evaluate effectiveness and the quality of life,~     specifically the risk of dry mouth, after radiation treatment for head and neck cancers.~   "
253728|NCT00230243|"~     This retrospective study is designed to provide a consistent method of screening and~     collecting data on patients who will serve as controls for a comparison of the efficacy of~     the available antifungal therapies used as salvage treatments for patients with refractory~     IFI or for patients with refractory IFI or for patients with IFI who are intolerant to~     standard antifungal therapies.~   "
253729|NCT00230230|"~     This randomized, multicenter, parallel-group, double-blind, double-dummy, placebo- and~     active-controlled study will evaluate the efficacy and safety of SCH 486757 in subjects with~     persistent cough resulting from a recent viral upper respiratory infection (URI). The primary~     objective is to assess the efficacy of SCH 486757 administered at a dose of 100 mg twice~     daily for 5 days in the reduction of cough severity score compared with placebo. The key~     secondary objective is to evaluate the reduction in the number of coughs with SCH 486757~     compared with placebo. Because codeine is a widely used as a cough medication, it is included~     as a treatment arm in the study.~   "
253730|NCT00230217|"~     This is an open-label, multi-center study with 2 arms. The primary objective is to assess the~     response to treatment with rasburicase in 2 populations of adult and pediatric patients with~     lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent,~     and those not previously treated with a uricolytic agent at their first relapse or refractory~     disease.~   "
253731|NCT00230204|"~     The purpose of this investigation is to assess the prevalence of infectious disease~     seropositivity (toxoplasmosis, rubella, cytomegalovirus [CMV]), herpes simplex virus type 1~     (HSV-1) and herpes simplex virus type 2 (HSV-2), syphilis, Epstein-Barr virus and H. pylori~     in a group of patients presenting with specific autoimmune diseases (rheumatoid arthritis~     [RA], undifferentiated connective tissue disorder [UCTD], Sjogren, antiphospholipid syndrome~     - APS, vasculitides, systemic lupus erythematosus [SLE], polymyositis, Hashimoto, multiple~     sclerosis, primary biliary cirrhosis [PBC], etc.), using the BioPlex 2200 and complementary~     EIA kits as compared to matched controls (by age, sex and ethnicity).~   "
253732|NCT00230191|"~     The primary objective of the study is to assess the effect of RK-0202 versus placebo on the~     incidence and severity of oral mucositis in subjects receiving radiation therapy for head and~     neck cancer. Concurrent chemotherapy is not allowed in the study.~   "
253733|NCT00230178|"~     This is a randomized, multi-center, open-label, parallel group study with three arms:~        -  Rasburicase alone~        -  Rasburicase followed by Allopurinol~        -  Allopurinol alone~      The primary objective is to compare the adequacy of control of plasma uric acid concentration~     and the safety profile among the three arms.~   "
253734|NCT00230165|"~     Blood contains red blood cells, white blood cells, and platelets, as well as a fluid portion~     termed plasma. We primarily study blood platelets, but sometimes we also analyze the blood of~     patients with red blood cell disorders (such as sickle cell disease), white blood cell~     disorders, and disorders of the blood clotting factors found in plasma.~      Blood platelets are small cell fragments that help people stop bleeding after blood vessels~     are damaged. Some individuals have abnormalities in their blood platelets that result in them~     not functioning properly. One such disorder is Glanzmann thrombasthenia. Most such patients~     have a bleeding disorder characterized by nosebleeds, gum bleeding, easy bruising (black and~     blue marks), heavy menstrual periods in women, and excessive bleeding after surgery or~     trauma. Our laboratory performs advanced tests of platelet function and platelet~     biochemistry. If we find evidence that a genetic disorder may be responsible, we analyze the~     genetic material (DNA and RNA) from the volunteer, and when possible, close family members to~     identify the precise defect.~   "
253735|NCT00230152|"~     The synergistic value of the fusion of physiologic and anatomical data has been described~     using several co-registration techniques for various nuclear medicine procedures and~     morphologic imaging modalities (single photon emission computed tomography-computed~     tomography [SPECT-CT], SPECT-magnetic resonance imaging [MRI], camera-based positron emission~     tomography [PET]-CT and PET-CT). The researchers hypothesize that fusion of nuclear medicine~     (NM) and CT data acquired sequentially in a single imaging session on one device is~     clinically superior to side-by-side evaluation of separately performed imaging tests. They~     hypothesize that more accurate localization of increased radiotracer activity on NM~     procedures will improve the diagnostic accuracy for detection of infection and will~     subsequently have a significant impact on patient management.~      The purpose of the present study is to assess the clinical value of this new technology of~     fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of~     an infection process.~   "
253736|NCT00230139|"~     The value of fusion of functional and anatomical data has been described using several fusion~     techniques for various nuclear medicine procedures and morphologic imaging modalities~     (SPECT-CT, SPECT-MRI, Coincidence-CT). We hypothesize that NM -CT data has advantages over~     the data obtained using separately performed NM study and conventional anatomic imaging as~     CT. We hypothesize that more accurate localization of the radio-isotope activity on NM images~     will improve diagnostic accuracy and will have an impact on patient management:~      Improved accuracy of NM study will improve tumor localization, the evaluation of the extent~     of disease and the post therapy follow up.~      It will direct other diagnostic procedures to lesions otherwise undetected, or exclude the~     need for more invasive procedures. It can also guide invasive procedures and~     radiation-therapy planning, thus improving therapy results and avoiding unnecessary~     treatment-related side effects.~   "
253740|NCT00230087|"~     The purpose of this study is to find out whether lowering the amount of iron in the body will~     result in less resistance to insulin and improved liver function in patients with type 2~     diabetes mellitus and non-alcoholic fatty liver disease. This may result in better diabetes~     control and/or a decrease in the amount of liver fat.~   "
253741|NCT00230074|"~     This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346~     compared to placebo in patients with mild or mild to moderate stages of ALS.~   "
253742|NCT00230061|"~     In this study we compare the efficacy of two different HBV-vaccination schedules in~     HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks~     and standard schedule: t=0,1,6 months.~   "
253743|NCT00230048|"~     Interactive Motivational Media for Perinatal Drug Abuse~   "
253744|NCT00230035|"~     Systemic lupus erythematosus, also known as lupus or SLE, is a chronic, multisystem,~     autoimmune disease in which the body's internal system of defense attacks its own normal~     tissues. This abnormal autoimmune response can result in damage to many parts of the body,~     especially the skin, joints, lungs, heart, brain, intestines, and kidneys. Both genetic and~     environmental risk factors are involved in the development of lupus, but these are poorly~     understood.~      SLE has an overall 10-year survival between 80 and 90%. However, we estimate that severe~     lupus not responding to the usual available treatments has a 50% mortality rate in 10 years.~     Kidney problems occur in 30% to 50% of lupus patients and may progress to kidney failure.~     Kidney disease due to lupus occurs more frequently in African-Americans and Hispanics. Lupus~     can affect many parts of the body and cause damage, but the severe form can result in death~     from kidney disease; cardiovascular disease, specifically atherosclerosis; central nervous~     system disease; and infections.~      Currently, no single standard therapy for treatment of severe SLE exists. Usually physicians~     prescribe an aggressive regimen of one or a combination of immunosuppressive/immunomodulatory~     treatments. This approach to therapy for all forms of severe SLE derives largely from studies~     of lupus nephritis. Current treatment, although effective in many people, are not effective~     in all patients and are associated with drug-induced morbidity. The design of the control arm~     for this study reflects the current status of treatment of SLE in the academic setting.~     Investigators may choose from a list of commonly used and currently available~     immunosuppressive/immunomodulatory treatments to optimize the treatment of their patients,~     based on their past treatment history and response to those treatments. Study treatments may~     consist of corticosteroids, cyclophosphamide (CTX), azathioprine, methotrexate, cyclosporine,~     mycophenolate mofetil (MMF), plasmapheresis, intravenous immunoglobulin (IVIG), rituximab,~     and leflunomide. Treatment may be changed as frequently and as necessary within the first~     year of the study to control the manifestations of SLE in each patient. New therapies that~     become available during the course of this trial may be added to the list of approved~     medications for this study.~      In response to the absence of a uniformly effective treatment for severe lupus, autologous~     hematopoietic stem cell transplantation (HSCT) has been proposed as a potential therapy.~     Hematopoietic stem cells are immature blood cells that can develop into all of the different~     blood and immune cells the body uses. Researchers believe that resetting the immune system~     may stop or slow down the progression of the disease. The main purpose of this study is to~     compare two ways of treating SLE: 1) high-dose immunosuppressive therapy (HDIT) followed by~     HSCT and 2) currently available immunosuppressive/immunomodulatory therapies.~   "
253745|NCT00230022|"~     Pilot trial of computer-based motivational intervention. Hypothesis: The brief~     computer-delivered intervention would result in higher motivation to change at follow-up.~   "
253746|NCT00230009|"~     Preliminary controlled trial of a brief intervention designed to reduce child maltreatment~     risk among low-income pregnant mothers. Foci will include major risk factors for~     maltreatment, including substance abuse, social isolation, depression, violence exposure, and~     maladaptive child-rearing attitudes/beliefs.~   "
253747|NCT00229996|"~     The Specific Aim of this project is to compare the efficacy and cost-effectiveness of~     continuous oral contraceptives versus leuprolide/norethindrone in the treatment of~     endometriosis-associated chronic pelvic pain. This comparison will be based on a randomized,~     double-blind, trial of women with chronic pelvic pain who have been diagnosed with~     endometriosis at the time of surgery within the last 3 years. We hypothesize that, over a~     12-month period of postoperative treatment, the efficacy of oral contraceptives is no worse~     than leuprolide/norethindrone, and that treatment with oral contraceptives is more~     cost-effective.~   "
253748|NCT00229983|"~     The goal of this study is to assess the efficacy of a new intervention based on motivational~     enhancement therapy among adolescents with a history of substance use.~   "
253749|NCT00229970|"~     This study evaluates the efficacy and safety of MK0476 intravenous administration in adult~     patients with acute asthma.~   "
253750|NCT00229957|"~     The purpose of the study is to determine whether occupational therapy and physiotherapy~     delivered in a primary care setting to adults with chronic illness is effective in improving~     health.~   "
253751|NCT00229944|"~     Cholera remains an important cause of diarrhoeal illness and death in Asia, Africa and Latin~     America. Antimicrobial therapy is an important adjunct to fluid therapy in the management of~     patients with cholera, and should be given to all patients with clinically moderate-to-severe~     disease since they can reduce the diarrhoea duration and stool volume by half. Current~     therapy for cholera is limited by increasing prevalence of multiply-resistant strains of~     Vibrio cholerae O1 or O139. Tetracycline and doxycycline had been the drugs of choice for~     treating cholera, but multiply-resistant strains are now present in all areas where cholera~     is endemic or epidemic. There is thus a need to identify alternative drugs that are effect in~     treating this disease.~      Azithromycin, a newer macrolide agent, is active in-vitro against V. cholerae, attains high~     concentrations in the gut lumen, has a long half-life, and is better tolerated than~     erythromycin, and older macrolide. In this study we will compare efficacy of a single, 1.0 g~     oral doses of azithromycin and ciprofloxacin in male patients, aged 18-60 years, with cholera~     due to V. cholerae O1 or O139. Patients with typical “Rice watery” stools of cholera, signs~     of severe dehydration and characteristic cholera vibrios in a dark-field stool microscopy.~     Patients who have coexisting illness which may confound assessment of the efficacy or safety~     will not be eligible. Only those patients who have V. cholerae O1 or O139 isolated from their~     pre-therapy stool and/or rectal swab culture and remains in the hospital for the entire~     duration of the study will be eligible for efficacy evaluation. A written informed consent~     will be obtained from each patients for their enrollment in the study.~      Patients will be hospitalized for full 5 days, and asked to return for a follow up evaluation~     7 days after discharge. After initial rehydration, patients will be observed for 4 hours, and~     only those with ³ 20 ml/kg of watery stools during this period will be enrolled for study.~     Treatment will be random, and blinded to study staff and patients. Clinical success of~     therapy will be defined as resolution of watery stool within 48 hours of administration of~     the study drug, and bacteriologic success will be defined as the inability to isolate V.~     cholerae O1 or O139 from fecal/rectal swab cultures of patients after 48 hours of therapy,~     i.e. on day 3 and on all subsequent days of the study. Patients in whom therapy clinically~     fails will be treated for 3 days with an effective alternate drug without opening the study~     code. Ninety one evaluable patients will be required in each group to show with a power of~     80% and a type I error of 5% that the two treatment regimens are equivalent (i.e. the 95%~     confidence interval for the difference in efficacy between the two groups is not greater than~     10%).~      If single-dose azithromycin therapy is found effective it will provide an important option~     for the treatment V. cholerae infections, especially those caused by multiply-resistant~     strains.~   "
253752|NCT00229931|"~     The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA)~     injection at the time of cataract surgery will improve visual acuity and decrease~     post-operative swelling in diabetic patients requiring cataract extraction as compared to the~     conventional treatment of laser following cataract surgery.~      The subjects will be followed for 11 visits over 3 year. Visits will occur at screening,1,~     3,6,9,12,18,24,30 and 36 months post surgery.~   "
253753|NCT00229918|"~     Prospective randomized clinical trial comparing Laser Alone v. Laser and posterior sub-tenon~     injection of triamcinolone acetonide for primary and refractory clinically significant~     macular edema.~   "
253754|NCT00229905|"~     The purpose is to see if any conclusions can be drawn about the uncommon heart defect:~     anomalous drainage of the inferior vena cava to the left atrium.~   "
253755|NCT00229892|"~     The purpose is to evaluate the investigators' length of incisions based on patient weight,~     operative times, hospital lengths of stay, pain medicine requirements, complications and~     costs. These data will lead to a new minimally invasive standard of care without a reduction~     in outcomes.~   "
253756|NCT00229879|"~     The purpose of this study is to do a literature review and combine all of the cases of the~     intrapericardial teratoma tumor and see if some conclusions can be made about this rare tumor~     in children.~   "
253757|NCT00229866|"~     The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a~     NG tube, G-tube placement or Nissen fundoplication.~   "
253758|NCT00229853|"~     The purpose of this study is to review the use of diverticulopexy, and collect data regarding~     the ease of the procedure and the overall outcome.~   "
253759|NCT00229840|"~     This study is being done to look at the relationship between brain structure and brain~     function in patients with epilepsy or focal brain lesions (abnormal areas) that require~     surgery. This study will look at an imaging technique called magnetic resonance imaging (MRI)~     for looking at the brain. Specifically, the study will look at functional MRI, which is an~     imaging technique that can map brain function by taking pictures of the brain as it performs~     different tasks such as reading, thinking, or moving a body part and diffusion tensor imaging~     (DTI), which will look at brain structure. These types of imaging may help us learn more~     about different areas of the brain and how those areas of the brain are used in children with~     epilepsy. We plan to study 30 children with epilepsy.~   "
253761|NCT00229814|"~     Tectal plate gliomas are relatively rare tumors of childhood with a reported incidence of~     10%. Their typical clinical presentation is symptoms and signs of hydrocephalus and are often~     incidentally diagnosed in the imaging work-up of children with hydrocephalus. Tectal tumors~     in children comprise a subcategory of brainstem tumors with unique clinical, imaging, and~     spectroscopic features. There is debate whether they truly represent brainstem tumors or~     whether they are a site of benign cellular overgrowth. The majority of these tumors are~     pathologically benign and show no or minimal growth. Not all tectal plate tumors, however,~     have this typically benign course. Some can manifest a more aggressive behavior. There have~     been reports in the past attempting to analyze the histology and behavior of these tumors.~     None of the prior series looking at these tumors have included Magnetic Resonance~     Spectroscopy (MRS) analysis.~      It is interesting that according to where tumors occur in the brainstem usually indicates~     what their histology and behavior is. Although not absolute, we know that tumors can have a~     very poor prognosis versus an extremely good prognosis depending on their location in the~     brainstem. Yet there are always the cases that do not act in the typical fashion and this is~     where MRS can prove helpful.~      This study is being done to look at a region of the brain, called the tectal plate, in~     children. This part of the brain can be involved by tumors. Because of the location of the~     tectal plate, it is usually very difficult and risky to get a biopsy (tissue sample) from~     this area. Magnetic Resonance Spectroscopy (MRS) is a non-invasive imaging technique that can~     look at the chemical make up of the brain. MRS may allow us to better understand the nature~     and behavior of these tumors. However, in order to understand disease in this area, we need~     to look at the normal chemical make up of the brain in children without tectal plate tumors.~     Healthy patients are being asked to participate as a normal volunteer. We anticipate having a~     total of 10 to 12 normal volunteers in the MRS study.~   "
253762|NCT00229801|"~     Clinical measurement of renal function is generally performed using either laboratory tests~     or nuclear medicine techniques, however, both of these techniques suffer from some~     limitations. Notably the lab tests only assess global, rather than individual kidney,~     function and the nuclear medicine tests are demanding to perform well. Children with brain~     tumors are often treated with chemotherapeutic in order to try and kill the cancer. Amongst~     the known side effect of some of the drugs used in the chemotherapy is the fact that they may~     damage the kidneys. For this reason the function of the kidneys is assessed using a~     laboratory test at 3 or 6 months intervals during the treatment. In addition, to the problem~     mentioned above the tests also require a separate visit to the hospital. Children with brain~     tumors who are undergoing chemotherapy also routinely have contrast-enhanced MRI of the brain~     performed at intervals of three months in order to evaluate the response of the tumor to the~     chemotherapy. Recently, MRI techniques have been developed which can evaluate single kidney~     renal function. The aim of this study is to establish if a single MRI exam can be used to~     assess both the effect of the chemotherapy on both the tumor and the renal function. The~     results of the MRI measurement of the single kidney renal function would be combined to~     provide a measure of global renal function and this would be compared with that obtained from~     the laboratory test. The MRI exam will require only require an extra 10 minutes of scanning~     time and will not affect the rest of the MRI exam in any way.~      This study is being performed to validate a new technique for measuring kidney function.~     Patients are being asked to volunteer for this study because they require serial contrast~     enhanced MR scans to monitor their response to chemotherapy. Because some chemo-therapeutic~     agents can be toxic to the kidney the patient's kidney function will also be evaluated using~     conventional methods, and the results of these tests can be compared to those obtained using~     MRI. We plan to study 50 children in this study. The additional procedure for measuring renal~     function will add 10 minutes to the duration of the MRI exam and will have no effect on the~     routine brain study. If validated the proposed MRI technique would allow renal function to be~     evaluated at the time of a routine, contrast enhanced MRI exam and would avoid additional~     testing using radioactive tracers or urine collection over 24 hours.~      If successful, MRI could be used to measure single kidney renal function in all any patient~     undergoing a routine MRI exam by simply extending the scanning time by a maximum of 10~     minutes. This would save such patients additional visits to the hospital and would have the~     advantage of measuring single kidney, rather than global, renal function.~   "
253763|NCT00229788|"~     For children who develop graft failure following cardiac transplantation, retransplantation~     is often considered. While some centers have reported equivalent results for~     retransplantation as compared to primary transplantation, this strategy remains~     controversial. We seek to examine outcomes following re-transplantation in children and~     identify risk factors for mortality. In addition, adult African-Americans have been reported~     to have lower survival following heart and other solid-organ transplantation. The~     relationship of recipient race to survival following pediatric heart transplantation has not~     previously been reported.~   "
253764|NCT00229775|"~     The purpose of this study is to determine whether artemether + lumefantrine is as effective~     as chloroquine + sulfadoxine pyrimethamine in the treatment of uncomplicated Plasmodium~     falciparum malaria~   "
253765|NCT00229762|"~     The goal of the study was to determine effectiveness of a telephone reminder to increase~     pneumococcal vaccination in a managed care population.~   "
253766|NCT00229749|"~     Chronic active hepatitis C viral infections are difficult to treat: current drug therapies~     can result in severe side effects that some patients will not tolerate. AVI-4065 Injection is~     a new drug designed to prevent the virus from reproducing in the body. We tested this drug in~     healthy adult volunteers to optimize the dosing regimen, and are now proceeding in adult~     patients with chronic active hepatitis C infections. Patients who have the disease and who~     have had treatment but without success, will be recruited for the study.~      The treatment of HCV patients initially consisted of subcutaneous injections given twice a~     day for 14-days. Treatment arms of 28 days, twice or three-times per day have been added.~   "
253767|NCT00229736|"~     Safety Study in subjects with Parkinson's Disease~   "
253768|NCT00229723|"~     The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg~     when given either concomitantly or as maintenance to a standard therapy of radiotherapy~     (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free)~     rate at 2 years.~   "
253769|NCT00229710|"~     This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to~     monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with~     type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment~     and follow-up, is 143 weeks.~   "
253770|NCT00229697|"~     This study is being carried out to see if ZD1839 is effective in treating metastatic breast~     cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.~   "
253771|NCT00229684|"~     This is a prospective 24-week, randomized, parallel-group, multi-center, active-controlled~     (pioglitazone 45 mg) open-label study designed to assess the effects of tesaglitazar 2 mg per~     day on components of renal excretion of creatinine in type 2 diabetics. The study comprises a~     2-week enrollment period, followed by a 24-week double blind treatment period and an 8-week~     follow-up period~   "
253772|NCT00229671|"~     The purpose of this study is to determine the rates of medication errors in pediatric~     outpatients in 6 office practices. Further, we wish to determine the effectiveness of a~     computerized physician order entry (CPOE) system in reducing errors.~   "
253773|NCT00229658|"~     This is an open label, observational study designed to collect data that characterize the use~     of SYMLIN following the introduction of the medication into the marketplace. Health care~     providers and subjects selected for study participation are intended to be representative of~     those providers prescribing, and subjects receiving, SYMLIN therapy.~   "
253812|NCT00229125|"~     The purpose of this study was to evaluate if the medication Gabapentin, which is not approved~     for the treatment of alcohol withdrawal, is effective in the treatment of alcohol withdrawal~     syndrome compared to treatment with Lorazepam.~   "
253813|NCT00229112|"~     This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus~     another intravenous antibiotic in the treatment of moderate to severe diabetic foot~     infections.~   "
253774|NCT00229645|"~     Major depression occurs with generalized anxiety disorder and panic disorder in up to 60% of~     psychiatric and primary care patients.(1) An estimated 85% of adults with depression~     experience significant symptoms of anxiety and 58% have a diagnosable anxiety disorder during~     their lifetime.(2) Numerous studies have shown that symptoms of anxiety are frequent in~     patients with major depressive disorder, and the presence of anxiety symptoms is associated~     with a more severe and chronic course.(3,4) This comorbidity has been associated with a~     greater severity of depression, poorer psychosocial functioning, poorer treatment response~     and higher risk for suicide.~      The data suggests that novel antipsychotics have antidepressant and anxiolytic effects. This~     study will explore the impact of this effect in patients with major depression and comorbid~     anxiety symptoms.~      This study offers the possibility of systematically reviewing the role of quetiapine in~     depression with anxiety. If the combination of an SSRI or SNRI and quetiapine proves to~     effective it could offer a viable alternative to widespread benzodiazepine use.~   "
253775|NCT00229632|"~     This study will determine whether a drug called idebenone is safe and effective in reducing~     the level of oxidants that are believed to damage the nervous system and hearts in patients~     with Friedreich's ataxia. Friedreich's ataxia is caused by an abnormality in the gene that~     makes a protein called frataxin, which is necessary for the proper functioning of~     energy-producing parts of cells called mitrochondria. In Friedreich's ataxia, the~     mitochondria become overloaded with iron, and high levels of harmful compounds called~     oxidants are formed. These oxidants are believed to damage the cells of the nervous system~     and hearts of people with Friedreich's ataxia. Idebenone is a man-made drug similar to a~     naturally occurring compound known as Coenzyme Q10. This study will test whether idebenone~     can alleviate some of the symptoms of Friedreich's ataxia and slow or halt the progression of~     the disease.~      Patients with genetically confirmed Friedreich's ataxia who are between 9 and 18 years of~     age, weigh between 65 and 175 pounds and can walk 25 feet with or without an assistive device~     may be eligible for this study. Candidates are screened with blood tests and a review of~     their medical records.~      Participants undergo the following tests and procedures:~        -  Medical interview and physical examination. Tests include blood and urine tests, an~          electrocardiogram, or EKG (recording of the electrical activity of the heart),~          echocardiogram (ultrasound test showing the pumping action of the heart, thickness of~          the heart walls, and any valve leakage), and a detailed neurological examination,~          including maneuvers such as copying a drawing and putting pegs in a board. Patients'~          parents are asked questions about how they feel their child's disease affects the~          child's quality of life.~        -  Magnetic resonance imaging (MRI) to examine the heart muscle and blood flow to the~          heart. MRI uses a magnetic field and radio waves to produce images of body tissues and~          organs. The patient lies on a table that is moved into the doughnut-shaped MRI scanner,~          wearing earplugs to muffle loud knocking and thumping sounds that occur during the~          scanning process. A catheter (plastic tube) is placed in a vein in the child's arm so~          that a chemical called gadolinium can be injected during the MRI study. Gadolinium~          brightens areas of the heart, improving the ability to see the heart and blood flow.~        -  Physical medicine and rehabilitation evaluations to test the child's physical~          functioning. These tests include gait evaluation, measurements of the ability to exert~          and maintain a constant force, assessment of visual-motor control and fine motor~          control, aerobic exercise endurance testing, and measurement of the ability of the~          child's heart and lungs to increase their effectiveness with exercise.~        -  Idebenone/placebo treatment. Patients are given a 6-month supply of either idebenone~          pills or placebo (pills that look like the study drug but have no active ingredient) to~          take three times a day. Patients are seen by their primary care physician after 1 and 3~          months on the study medication for a brief physical examination. In addition, they have~          blood and urine tests once a month while on medication to check for any abnormalities.~        -  6-month examination. After 6 months on the study drug, patients return to NIH to repeat~          all the tests listed above to determine the effects of idebenone treatment.~   "
253776|NCT00229619|"~     This study will test whether the immune-suppressing drug rituximab can increase blood counts~     and reduce the need for transfusions in patients with moderate aplastic anemia, pure red cell~     aplasia, or Diamond Blackfan anemia. These are rare and serious blood disorders in which the~     immune system turns against bone marrow cells, causing the bone marrow to stop producing red~     blood cells in patients with pure red cell aplasia and Diamond Blackfan anemia, and red blood~     cells, white blood cells and platelets in patients with aplastic anemia. Rituximab is a~     laboratory-made monoclonal antibody that recognizes and destroys white blood cells called~     lymphocytes that are responsible for destroying bone marrow cells in these diseases. The drug~     is currently approved by the Food and Drug Administration for treating patients with B-cell~     non-Hodgkin lymphoma, a disease of white blood cells.~   "
253777|NCT00229593|"~     The purpose of this study is to determine the usefulness of two transdermal gels to be used~     in the future development for a male contraceptive.~   "
253778|NCT00229580|"~     The purpose of this study was to explore whether a brief (3 session) intervention would~     impact health behavior of veterans with hepatitis C. The main focus of the intervention was~     on reduction of heavy drinking with patients who have liver disease. Other study goals were~     to increase the likelihood that patients would seek out substance use treatment and/or~     hepatitis C health care services. The study also tested the use of a liver function test~     called CDT/GGT in detecting heavy drinking. The main hypothesis was that a 3 session~     intervention with personalized feedback about health behavior would result in a reduction in~     alcohol use and increased use of substance use treatment and hepatology health care.~   "
253779|NCT00229567|"~     Bowel function after bowel surgery is delayed (postoperative ileus)by both opiates and the~     surgery itself. We hypothesized that decreasing opiate use by other analgesics will speed the~     return of bowel function after surgery. Lidocaine and Ketamine are drugs that appear to be~     synergistic and do not slow peristalsis. This study is a Randomised Controlled Trial of~     Lidocaine Infusion Plus Ketamine Injection versus Placebo to to determine whether they will~     decrease opiate use and then whether decreased opiate use will speed the return of bowel~     function.~   "
253780|NCT00229554|"~     Despite strong evidence for the effectiveness and cost-effectiveness of a variety of~     colorectal cancer (CRC) screening methods for reducing CRC mortality, current CRC screening~     rates fall far below the levels needed to significantly impact CRC mortality. Unfortunately,~     however, the existing literature on patient CRC screening behavior does not yet provide a~     sufficient evidence base for making sound recommendations regarding how to most effectively~     improve upon these rates in the VA. This study will inform future CRC screening promotion~     efforts and make important scientific contributions to existing literature by: (a)~     delineating the relative contribution of patient cognitive, environmental and background~     factors to CRC screening behavior using a multi-level, theory driven analysis approach on a~     nationally representative sample, and (b) identifying the determinants of variation in CRC~     screening behavior across vulnerable population subgroups.~   "
253781|NCT00229541|"~     The randomised controlled trial explores the efficacy of a counselling interview on an~     multidisciplinary multimodal intervention to ameliorate the somatic, mental and social~     medical progress of rheumatoid arthritis in gainfully employed insurants of compulsory health~     insurances and statutory pension insurances . Additionally, the feasibility to recruit a~     study population via databases of compulsory health insurances is examined.~   "
253782|NCT00229528|"~     COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in~     the body that make platelets stick together. These platelets may be important in the~     initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin~     maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in~     platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the~     current study is designed to determine whether paroxetine will decrease COAT-platelet~     production in normal volunteers and patients with cardiovascular disease.~   "
253783|NCT00229515|"~     The purpose of this study is to determine which from the four combinations~     tirofiban+sirolimus eluting stent (SES), tirofiban+bare metal stent (BMS), abciximab+SES,~     abciximab+BMS is the possible gold standard treatment for ST-segment elevation myocardial~     infarction in terms of efficacy and cost-efficacy.~   "
253784|NCT00229502|"~     The purpose of this study is to examine and compare changes in the specific thinking skills~     of patients with RRMS who are receiving treatment with one of three immunomodulatory~     medications (Avonex, Copaxone, or Rebif).~   "
253785|NCT00229476|"~     The primary purpose of the research study is to use recordings of brain electrical activity~     (through electroencephalogram, or EEG) and symptom measurements to determine whether patients~     are likely to show a response to medication or placebo treatment during a treatment trial for~     depression.~   "
253786|NCT00229463|"~     The purpose of this study is to identify genes involved in depression. Specifically, the~     investigators will analyze some genes that may be related to whether or not a person responds~     to antidepressant medication. This project is part of basic scientific research to increase~     understanding of the role of genetic influences in psychological and mental processes~     involved in the response to treatment for depression.~   "
253892|NCT00227955|"~     This study will evaluate the effectiveness of five combinations of drug therapy and~     psychotherapy in maintaining remission of depression symptoms in people with recurrent major~     depression.~   "
253787|NCT00229450|"~     During perimenopause (the time just prior to menopause), women often notice many biological,~     psychological, and social changes. In particular, some women experience depressive symptoms~     during perimenopause that are severe enough to warrant antidepressant medication. Whether or~     not women with perimenopausal depression respond to antidepressant medication may depend on~     the level of estrogen in their blood. We would like to investigate whether estrogen will help~     the women who only partially respond to antidepressant medications. We also want to examine~     how different doses of estrogen may affect individuals differently.~   "
253788|NCT00229437|"~     The purpose of this study is to determine the efficacy and safety of TAK-128, once daily~     (QD), in treating subjects with diabetic peripheral neuropathy.~   "
253789|NCT00229424|"~     The purpose of the study is to verify superiority of the lafutidine group over the placebo~     group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the~     patients with mild reflux oesophagitis.~      Furthermore, the followings are compared:~      The improvement effect in heartburn and other subjective symptoms, and dosing frequency of~     MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine~     20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment~     group in patients with mild reflux oesophagitis.~   "
253790|NCT00229411|"~     The purpose of the study is to check whether training mixed teams of physicians and nurses~     from intensive care units on patient simulators improves teamwork within the teams.~   "
253791|NCT00229398|"~     Assessing psychiatric and physiological co-morbidity in TRD and non-TRD patients~   "
253792|NCT00229385|"~     Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in~     response to Ziprasidone and in cognitive functioning as compared with OCD patients~   "
253793|NCT00229372|"~     Assessing the efficacy of Posttraumatic Stress Disorder (PE) treatment for chronic~     Posttraumatic Stress Disorder (PTSD)~   "
253794|NCT00229359|"~     Compare PTSD and non-PTSD subjects on several demographic, cognitive and military variables~   "
253795|NCT00229346|"~     Assessing FM and psychiatric disorder in patients suffering from PMS or PMDD~   "
253796|NCT00229333|"~     The goal of the present study is to compare the effectiveness of the active (S)-enantiomer of~     citalopram, escitalopram with placebo in the treatment of patients with depressive syndrome~     complicating Alzheimer’s dementia (AD), vascular dementia (VD) or mixed dementia (MD), for 8~     weeks of double-blind treatment.~   "
253797|NCT00229320|"~     Assessing OCD before and after group therapy~   "
253798|NCT00229307|"~     Comparing the efficacy of 40 minutes PE treatment to 20 minutes of the same treatment~   "
253799|NCT00229294|"~     Assessing FM and psychiatric state among PTSD, MDD and healthy participants~   "
253800|NCT00229281|"~     Assessing Anxiety in patient suffering from anxiety disorders (NOT OCD or PTSD)before and~     after group therapy~   "
253801|NCT00229268|"~     The purpose of this study is to determine whether the level of FOXA2 expression in fat tissue~     is a biomarker of insulin resistance. To test this hypothesis, we will perform~     euglycemic-hyperinsulinemic clamps in normal and obese human subjects to calculate insulin~     sensitivity, and see if insulin sensitivity correlates with the FOXA2 expression in~     subcutaneous fat.~   "
253802|NCT00229255|"~     The purpose of this study is to test the relationship between frequency of meals and hepatic~     fat content and insulin sensitivity. We, the researchers at Rockefeller University,~     hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent~     insulin resistance and reduce hepatic lipid content. In contrast, frequent, carbohydrate-rich~     meals will predispose to hepatic steatosis (non-alcoholic) and insulin resistance.~      This is a 6 week inpatient study.~   "
253803|NCT00229242|"~     MAIN: The benefits of treating high blood pressure successfully to normal levels on heart~     function are the same regardless of which particular combination of drugs are used.~     SECONDARY: Measurement of heart function using a comprehensive ultrasound imaging method~     (Echocardiography) and an objective test of functional ability are better predictors of~     changes in heart function with successful hypertension treatment, than subjective signs of~     heart failure.~   "
253804|NCT00229229|"~     Type 2 diabetes can be prevented by lifestyle changes in high-risk subjects. However,~     controversies exist on nutritional management of diabetes. Recent data suggests that glucose~     and insulin responses are affected by not only the quality, but the quantity of carbohydrate~     consumed. This is referred to as glycemic load.~      To date, there have not been any prospective randomized studies which examine the utility of~     a low glycemic load diet.~      The purpose of the proposed study is to compare the effectiveness of a Canada Food Guide Diet~     with a low glycemic load diet on blood sugar control in overweight type 2 diabetics.~   "
253805|NCT00229216|"~     The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the~     treatment of bacterial vaginosis.~   "
253806|NCT00229203|"~     This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2,~     given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or~     refractory multiple myeloma (MM).~   "
253807|NCT00229190|"~     Nasal lavage could be an integral component of assessing airway inflammation. Research into~     the reproducibility of cell counts is key to understanding the value of lavage results.~      The objective of this study is to evaluate and compare the reproducibility of a common nasal~     lavage technique and its variation in a sample of subjects with nasal symptoms (e.g. runny~     nose, congestion, sneezing, post nasal drip), and in individuals without nasal symptoms.~   "
253808|NCT00229177|"~     The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to~     placebo in patients with acute ischemic stroke.~   "
253809|NCT00229164|"~     The purpose of this study is to investigate the effect of high frequency TENS and compare to~     the placebo effect by sham TENS in a randomized control study.~   "
253810|NCT00229151|"~     The purpose of this study is to determine if sleep deprivation and sleep phase advancement is~     effective treatment of bipolar patients in a depressive phase.~   "
253811|NCT00229138|"~     This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus~     at both reference and reduced levels. This study will take into account safety aspects such~     as decreased renal toxicity by reducing the overall exposure to tacrolimus.~   "
253814|NCT00229099|"~     The purpose of the study is to establish the equivalence of GerEpo with the standard~     treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect~     to hemoglobin response and to establish the longer-term safety profile of GerEpo, with~     special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity~     related adverse event~   "
253815|NCT00229086|"~     Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux~     Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo~     2000-04~   "
253816|NCT00229073|"~     The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal~     ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).~   "
253817|NCT00229060|"~     The purpose of this study is to compare the clinical response rate of doripenem versus a~     comparator in the treatment of hospitalized patients with complicated intra-abdominal~     infections.~   "
253818|NCT00229047|"~     We, the researchers at Lawson Health Research Institute, propose to investigate the impact of~     surgical ischemia and reperfusion on skeletal muscle microcirculation using a hand-held~     microscope.~   "
253819|NCT00229034|"~     An observational study to determine the effect of APC and Epo in reducing the systemic~     inflammatory response during severe sepsis.~   "
253820|NCT00229021|"~     The purpose of this study is to compare the microbiological cure rate of doripenem versus a~     comparator antibiotic in the treatment of patients with complicated urinary tract infection~     or pyelonephritis. The study will also characterize the safety and tolerability of treatment~     with doripenem in patients with complicated urinary tract infection or pyelonephritis.~   "
253821|NCT00229008|"~     The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the~     water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator~     in the treatment of patients with nosocomial pneumonia.~   "
253822|NCT00228995|"~     The purpose of this study is to assess changes in physical function in elderly patients (>=~     65 years of age) with chronic anemia (Hb <= 11.0 g/dL) due to anemia of unknown cause and~     receiving weekly subcutaneous doses of Epoetin alfa (PROCRITÂ®) versus placebo.~   "
253823|NCT00228982|"~     The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril~     versus a comparator in the treatment of patients with complicated skin and skin structure~     infections.~   "
253824|NCT00228969|"~     The primary objective of this study is to evaluate the efficacy, safety, and tolerability of~     4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in~     subjects who are between 18 and 70 years of age, inclusive~   "
253825|NCT00228956|"~     You are invited to participate in a research study looking at metabolism (breakdown) and~     effects of aromatase inhibitors. The purpose of this research is to try to identify which~     women who take an aromatase inhibitor are more likely to have certain benefits or side~     effects from the drug. We will do so by determining whether there are differences that~     normally occur in genes that you have inherited from your parents that might influence the~     way individuals respond to medications. If you agree to participate in this study, you will~     be asked to sign this informed consent form.~   "
253826|NCT00228943|"~     The purpose of this proposal is to improve our understanding of the role of tryptophan and~     serotonin in hot flashes. The main hypothesis is that alterations in tryptophan and serotonin~     levels are involved in the induction of hot flashes in women with breast cancer and genetic~     variations in the serotonin receptors and transporters also play a role.~   "
253827|NCT00228930|"~     The purpose of this research is to try to identify which women who take tamoxifen are likely~     to suffer from hot flashes or are more likely to have other side effects or benefits from the~     drug. The researchers will do so by determining whether there are mutations that normally~     occur in human DNA that might influence the way individuals respond to medications.~   "
253828|NCT00228917|"~     This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP)~     booster phase, subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or~     Tritanrix™-HepB/Hiberix™ (active control) at 15 to 18 or 24 months in a single-blind manner~     so that the subjects' parents will not know which vaccine was administered to their child. In~     the Mencevax ACWY phase at 24-30 months, a dose of Mencevax™ ACWY will be given in an open~     manner to only those subjects who received less than 4 doses of Tritanrix™-HepB/Hib-MenAC. No~     blood samples will be taken in this safety study.~   "
253829|NCT00228904|"~     Diabetic neuropathy is a progressive complication causing serious problems in 25-40% of~     diabetic patients. Anecdotal reports have indicated improvement with pulsatile IV insulin~     therapy in affected patients otherwise resistant to all conventional therapies. Significant~     complications produce painful peripheral dysesthesias, loss of sensation and gastroparesis.~     This study is designed to test the effectiveness of pulsatile IV insulin therapy on diabetic~     neuropathy.~   "
253830|NCT00228891|"~     Diabetic neuropathy is a progressive complication causing serious problems in 25-40% of~     diabetic patients. Anecdotal reports have indicated improvement with pulsatile IV insulin in~     patients otherwise resistant to all conventional therapies. Significant complications produce~     painful peripheral dysesthesias, loss of sensation and gastroparesis. This study is designed~     to test the effectiveness of pulsatile insulin delivery on diabetic neuropathy.~   "
253831|NCT00228878|"~     The purpose of this study is to determine if restoring normal metabolic function in patients~     with either type I or type II diabetes can improve the impact of the consequences of diabetic~     complications on the overall quality of life of diabetic patients. Patients are treated once~     a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A 44~     item questionnaire is completed prior to the start of the treatment and quarterly thereafter~     with detailed analysis performed to measure progress and outcomes.~   "
253832|NCT00228865|"~     To determine if restoring normal metabolic function in patients with either Type I or Type II~     Diabetes can improve overall cognitive function. Patients are treated once a week with~     pulsatile intravenous insulin therapy mimicking normal insulin secretion and high amounts of~     oral glucose consumption.~   "
253833|NCT00228852|"~     This is a multi-institution, single arm, non-randomized pilot study coordinated by the~     Pediatric Blood and Marrow Transplant Consortium. Eligible patients will have severe combined~     immunodeficiency syndrome (SCID) or severe T-cell immunodeficiency disorder. Patients with~     these disorders do not have properly functioning immune systems. Without treatment, these~     disorders result in early childhood death. The standard treatment used for these diseases is~     to give the patient a stem cell transplant from a matched donor. The donor cells can be from~     a family member, an unrelated marrow donor or umbilical cord blood. The donor source will~     impact on transplant risks and approaches to the preparative regimen.~      There have been many different preparative regimens used for patients with SCIDS or severe~     T-cell immunodeficiency syndromes. Some patients have gotten no preparative regimen, while~     others have gotten only antithymocyte globulin (ATG; immune proteins made in horses that,~     when given, will kill lymphocytes). Still other patients have gotten conventional~     chemotherapy. In children treated with nothing or ATG alone, there is an increased risk of~     graft failure or only partial engraftment. When this happens, patients need life-long therapy~     with immunoglobulins to support the immune system. Children treated with chemotherapy~     generally have full immune recovery, but also may have major side effects from the~     chemotherapy. The side effects include infection, organ failure and infertility.~      This protocol, in combination with a parallel study with a separate preparative regimen, will~     attempt to answer the question of which patients with primary immunodeficiencies need a~     preparative regimen and what intensity is needed. Patients will be enrolled according to~     disease type and donor source. The purpose of this study is to see how much chemotherapy is~     actually needed for the transplant to work. To be able to do this and still make the~     transplant work, the drugs used to temporarily weaken the immune system will be strengthened.~     In groups, patients will be treated with lowering doses of the busulfan to find the lowest~     dose of this drug that is needed to get full immune recovery. The investigators hope this~     regimen will result in complete immune system recovery while limiting the side effects of~     chemotherapy. A second purpose of this study is to track the recovery of different parts of~     the immune system. The investigators also want to identify whether the recovery is coming~     from donor stem cells or from the patient.~      The patient will be admitted to the hospital to have the transplant and is expected to stay~     for up to 4 to 6 weeks. The preparative regimen will be made up of busulfan, fludarabine and~     antithymocyte globulin (ATG). After the preparative regimen, the cells from the donor will be~     given. To try and keep the patient's body from rejecting the donor cells and the donor cells~     from attacking the patient's body (graft-versus-host disease, or GVHD), cyclosporine will be~     given.~      The investigators will draw an extra 2 - 4 teaspoons of blood at specified time points to~     test for immune recovery and donor cell chimerism (the portion of the blood that belongs to~     the donor). Standard bone marrow transplant (BMT) clinical care will be provided with respect~     to pretransplant evaluation, peritransplant support, and posttransplant follow-up.~   "
253893|NCT00227942|"~     This study will evaluate the effectiveness of estrogen replacement therapy in treating~     depression in menopausal women with hot flashes and insomnia.~   "
253834|NCT00228839|"~     Acute graft versus host disease (GVHD) remains one of the most significant and potentially~     lethal complications of allogeneic bone marrow transplantation. Depending upon the type of~     transplant, the incidence of acute GVHD varies between 20 - 50% in related donor transplants,~     or as high as 70 - 90% in unrelated donor transplants. Acute GVHD affects the skin, liver and~     gastrointestinal (GI) tract and usually occurs within 20 - 40 days of the bone marrow~     infusion.~      Steroids are the standard initial treatment of acute GVHD, with approximately 50% of the~     patients either free of disease or requiring no further therapy. In the remaining patients,~     the GVHD either does not respond or it comes back during the tapering of steroids. These~     patients have a much worse prognosis with a mortality rate greater than 70%. Studies using~     additional agents such as antithymocyte globulin (ATG), monoclonal antibodies, and~     anti-lymphocyte globulin showed no improvement over the use of steroids alone. This leads the~     investigators to look for new immunosuppressive agents that can reduce the risk and severity~     of acute GVHD.~      The major purpose of this study is to evaluate the way the body uses and absorbs (the~     pharmacokinetic profile) a drug called anti tumor necrosis factor antibody (infliximab) for~     the treatment of acute GVHD. Infliximab is currently indicated for the treatment of~     immunologic-based diseases (rheumatoid arthritis, moderately to severely active Crohn's~     disease, and fistulizing Crohn's disease), assuming patients have had inadequate responses to~     conventional therapy. It is not approved for the treatment of GVHD.~      This is a Phase I pharmacokinetic study that is coordinated by the Pediatric Blood and Marrow~     Transplant Consortium (PBMTC). The study will be conducted in the Blood and Marrow~     Transplantation (BMT) program at Children's Healthcare of Atlanta - Egleston, Emory~     University Department of Pediatrics. The goal is to enroll 1 - 2 patients on this study;~     accrual will be via the BMT program. Eligible patients must be less than 18 years of age.~      Patients with newly diagnosed acute GVHD will be able to participate in the study. Patients~     will receive a single dose of infliximab in the clinic. Since this is a Phase I study, the~     patients will have blood samples drawn to measure the pharmacokinetics of the drug. A total~     of 16 blood samples will be drawn over 84 days. The samples will be labeled with a code,~     processed, frozen, and then sent in a batch to the PBMTC designated laboratory for testing.~     Patients will continue on any drugs they were getting for the prevention of GVHD. Additional~     doses of infliximab may be given. This decision will be based on the results of the blood~     testing.~   "
253835|NCT00228813|"~     The purposes of this study are:~        -  To examine the engraftment rate in patients receiving in vivo T-cell-depleted G-CSF~          stimulated bone marrow from partially mismatched related donors.~        -  To evaluate the incidence and severity of acute and chronic graft-versus-host disease in~          patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially~          mismatched related donors.~   "
253836|NCT00228696|"~     The Late Effects Study is being conducted in order to answer scientific questions and to~     serve as a resource for Wilms tumor patients and their families. Patients must have been~     enrolled on the NWTS-5 protocol in order to be eligible for this study.~   "
253837|NCT00228683|"~     This is a study to collect and bank tissue specimens and blood from patients with~     Hepatoblastoma.~   "
253838|NCT00228670|"~     The purpose of this study is to: 1) to develop a method to quantify Epstein Barr Virus (EBV)~     load in lung tissue of humans and to determine whether EBV viral load is significantly higher~     in lung tissue from patients with idiopathic pulmonary fibrosis (IPF) than in control lung~     tissue; 2) to determine whether EBV localized to epithelial cells in IPF lungs and to relate~     epithelial positivity to tissue viral load; 3) to measure viral load in induced sputum from~     IPF subjects over time in order to determine whether periodic active herpes virus replication~     occurred in the respiratory tract; and 4) to compare longitudinal measures of viral load in~     induced sputum with simultaneously collected saliva in order to assess the clinical utility~     of the two approaches.~   "
253839|NCT00228657|"~     Patients resuscitated with 4% Albumin will have less incidence and reduced severity of~     pressure injuries than patients resuscitated with 0.9% Sodium Chloride due to the improved~     intravascular oncotic pressure effected from higher albumin levels.~   "
253840|NCT00228644|"~     Availability of sulfur amino acids (SAA) is critical for glutathione/glutathione disulfide~     (GSH/GSSG) and cysteine/cystine (CYS/CYSS) redox in vivo and for many other physiologic~     functions including protein synthesis, nitrogen balance, digestion, osmotic regulation,~     detoxification, hormonal regulation, biologic methylations, and cell growth regulation. GSH~     conjugation and sulfate conjugation represent quantitatively important pathways for chemical~     detoxification, which imposes substantial burden upon SAA supply. The primary hypothesis is~     that SAA deficient diet and acetaminophen (APAP) administration will perturb Cys metabolism~     and GSH redox homeostasis in human plasma and urinary output of SAA metabolites. Because both~     of these variations affect SAA homeostasis, it is believed that the combination of these~     treatments will produce an interactive effect in which 2-day SAA deficiency will alter APAP~     metabolism, APAP will affect SAA homeostasis, and the treatments together will alter the~     global metabolic profile, as measured by 1H-NMR spectroscopy.~   "
253841|NCT00228631|"~     In this study, patient blood samples from NMA transplants will be provided by Pittsburgh, and~     samples from myeloablative transplants will be provided by Atlanta (comparative controls).~     Samples would be obtained pre- and post-BMT from the recipient at a total of 7 timepoints,~     and from the donor at one timepoint.~   "
253842|NCT00228618|"~     The purpose of this study is to determine the level of sulfur amino acids in the diet that is~     needed to maintaining glutathione antioxidant status. This information could prove very~     useful in medicine because it could allow identification of an optimal diet for control of~     antioxidant levels. This diet could be used in conjunction with other therapies in order to~     prevent or delay oxidative stress and any diseases that may result from this. Total study~     participation will include a screening visit and a 14-day study period where dietary intake~     of sulfur amino acids will be controlled. We aim to enroll 12 normal subjects at Emory~     University Hospital.The primary hypothesis is that steady-state GSH/GSSG and CYS/CYSS redox~     in human plasma will become oxidized due to SAA intake at 0% of the RDA and reduced due to~     SAA intake at 3X the RDA.~   "
253843|NCT00228605|"~     The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl~     for the potential treatment of breakthrough pain episodes in patients who have chronic~     noncancer pain.~   "
253844|NCT00228592|"~     The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs,~     in patients who have received liver transplants due to liver failure caused by Hepatitis B~     infection. Patients will be evaluated over a 6 month to 1.5 year period to evaluate whether~     or not the drugs prevent the Hepatitis B virus from infecting the new liver.~   "
253894|NCT00227929|"~     This study will evaluate the effectiveness of culturally sensitive treatment versus regular~     care in treating depressed Chinese Americans.~   "
253895|NCT00227916|"~     The purpose of this study is to test the efficacy of an individual motivational interview for~     reducing alcohol and marijuana-related harm as well as alcohol and marijuana use in~     incarcerated teens.~   "
253972|NCT00226824|"~     The purpose of this study is to determine the safety, tolerability and efficacy of~     galantamine in tic disorders. The impact of galantamine on commonly associated behaviors~     (i.e. attention, obsessions, etc.) will also be examined.~   "
253845|NCT00228579|"~     In this study, we propose to determine the effect of weight loss on amount of body fat, and~     on body fat distribution, in severely obese patients. We also want to determine what~     measurements (waist, hip or thigh circumference) best show the changes in body fat and fat~     distribution in this group. Most importantly, we want to relate the changes in body~     measurements to changes in health indicators (blood cholesterol, blood pressure, blood~     sugars, liver function). With the findings of this study, clinicians should be able to~     predict an improvement in health based on a change in waist, hip or thigh size. Because this~     is a pilot study, we will focus on women, who make up the bulk of our clinic population. We~     will also focus on racial differences between Caucasians and Blacks.~   "
253846|NCT00228566|"~     The purpose of this study is to assess patient reported outcomes with armodafinil treatment~     in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to~     engage in life activities (ie, daily or work and family and/or social activities), and~     effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also~     be assessed.~   "
253847|NCT00228553|"~     A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of~     Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated~     with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep~     Disorder~   "
253848|NCT00228540|"~     An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated~     Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with~     Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period)~   "
253849|NCT00228527|"~     To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in~     children 1 to 11 years old with inflammation of their esophagus or food pipe (esophagitis)~     caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.~      To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the~     lining of the food pipe.~      To collect information that will describe the psychological, social, and economic effects on~     the primary caregiver of raising children ages 1 to 5 years old with GERD.~   "
253850|NCT00228514|"~     At one site, patients participating in the Corona main study are asked to participate in the~     PET-substudy. Before and 6 months after study medication is started a Positron Emission~     Tomography (PET-scan) is performed to study the effect of rosuvastatin in Chronic Heart~     Failure on myocardial perfusion (reserve)~   "
253851|NCT00228488|"~     Two different patient populations will be targeted for this study. The first population (SP1)~     will include patients with recurrent/metastatic head and neck cancers, excluding salivary~     gland carcinomas. The second population (SP2) will include treatment-naïve patients with~     locally advanced squamous cell head and neck cancer (SCHNC).~      SP1 will be treated with palliative intent and the patients can be treatment-naïve or have~     received prior chemotherapy. Study treatment will consist of Iressa (gefitinib) alone.~      SP2 will be treated with radical intent. The patients must be treatment-naïve and study~     treatment will consist of induction Iressa for 3 weeks followed by a combination of Iressa~     plus cisplatin and concurrent irradiation.~   "
253852|NCT00228475|"~     The purpose to measure the concentration of budesonide in breast milk of asthmatic mothers on~     their normal maintenance treatment with budesonide (Pulmicort Turbuhaler), and to estimate~     the exposure of budesonide to infants.~   "
253853|NCT00228462|"~     This study is being carried out to see if quetiapine (Seroquel) is effective in preventing~     patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it~     compares with non-active treatment.~   "
253854|NCT00228449|"~     The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and~     pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with~     chronic kidney disease (CKD) who are on hemodialysis.~   "
253855|NCT00228436|"~     The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and~     pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants~     with chronic kidney disease (CKD) not on dialysis who had not received erythropoiesis~     stimulating agent (ESA) treatment.~   "
253856|NCT00228423|"~     The purpose of this study is to determine whether the combination of clopidogrel with aspirin~     prevents the development of blockages (atherosclerosis) in vein grafts one year after~     coronary artery bypass surgery (CABG) compared to aspirin alone.~   "
253857|NCT00228410|"~     To compare the safety and the efficacy of tigecycline to vancomycin with aztreonam in~     treating hospitalized patients with complicated skin and/or skin structure infections.~   "
253858|NCT00228397|"~     To evaluate the safety and tolerability of long-term therapy with 3 dose levels of oral~     CCI-779 administered to subjects with relapsing MS who completed study 3066A2-205-WW.~   "
253859|NCT00228384|"~     To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol~     stent for the treatment of superficial femoral artery (SFA) occlusive disease in long~     lesions.~   "
253860|NCT00228371|"~     The aim of this study is to evaluate the effectiveness and the safety of deep brain~     stimulation in drug resistant epilepsy.~      This is a double blind, controlled and randomized clinical trial with two cross-over groups~     and four phases.~      Phase 1 : base line, open phase consisting of follow-up of patients with their standard~     treatment.~      Phase 2 : Randomisation, lead implantation, followed by 3 months wash out period with the~     stimulator switch OFF.~      Phase 3 : cross-over, double blind phase : 3 months with stimulator switch ON or OFF~     depending on randomization allocation, followed by 3 months with the stimulator switch on the~     opposite position. The placebo consisting of turn OFF the stimulator.~      Phase 4 : open phase, one year follow-up of all patients with the stimulator switch ON.~   "
253896|NCT00227903|"~     The purpose of this study is... To assess whether a behavioral treatment that combines~     motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective~     than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g.~     marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using~     and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer~     gestations and greater birth weight).~   "
253952|NCT00227084|"~     To evaluate whether Arista AH which contains microporous polysaccharides used as a powder~     applied to the wound area during mammary surgery reduces the amount of bleeding and the~     duration of surgery. Both mammae are operated on in the same procedure, and one side without~     Arista serves as control side~   "
253861|NCT00228358|"~     This phase I trial studies the safety and the ability to expand laboratory-treated T cells~     when given together with cyclophosphamide or denileukin diftitox in treating patients with~     human epidermal growth factor receptor (HER)-2/neu overexpressing metastatic breast cancer,~     ovarian cancer, or non-small cell lung cancer previously treated with HER-2/neu vaccine.~     Laboratory-expanded T cells may help the immune system in different ways and stop tumor cells~     from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Biological therapy, such as denileukin diftitox, may stimulate the immune system in~     different ways and stop tumor cells from growing. Giving laboratory-treated T cells together~     with cyclophosphamide or denileukin diftitox may allow the immune system to kill more tumor~     cells~   "
253862|NCT00228345|"~     The purpose of this study is to determine whether impaired glucose handling (abnormality in~     the way the body processes blood sugar) can cause a neuropathy (damage to the nerves).~   "
253863|NCT00228332|"~     A Double-blind, placebo-controlled trial investigating the effect of a treatment with~     zinkgluconaat for verrucae vulgares~   "
253864|NCT00228319|"~     The purpose of this study is to try and understand if there is added benefit or increased~     harm when antioxidant nutritional supplements are added to traditional chemotherapy in the~     treatment of ovarian cancer.~   "
253865|NCT00228306|"~     Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in~     individuals with chronic stroke.~   "
253866|NCT00228293|"~     Using an investigational monitor/defibrillator that passively records CPR quality parameters,~     including chest compression rate and depth and ventilation rate and volume, we are~     prospectively recording CPR quality during sequential in-hospital cardiac arrests at the~     University of Chicago Hospitals. Using an audio feedback system linked to this device, we are~     studying whether such audio feedback improves CPR quality when provided to rescuers trained~     in the use of the device.~   "
253867|NCT00228280|"~     Ph.D project: Periapical bone healing after apicectomy with and without retrograde root~     filling.~      The aim of this study is to assess periapical bone healing after apicectomy without a filling~     and apicectomy combined with a retrograde filling material, MTA. Further, we will estimate~     risk factors in non-healing cases.~      Study hypothesis: There is no difference in treatment outcome between:~      Periapical bone healing after apicectomy with retrograde root filling and Periapical bone~     healing after apicectomy without retrograde root filling~   "
253868|NCT00228267|"~     Hypothesis A single subanesthetic dose of propofol will result in improved pain and quality~     of life for the next 30 days in persons with chronic daily headache (CDH)~      Specific objectives To measure the effect of a single infusion of propofol at 40 mcg / kg /~     minute over 60 mins on headache-related quality of life (measured by the Headache Disability~     Index) and on headache severity (measured by the Headache Index) in subjects with chronic~     daily headache over 30 days45-47~   "
253869|NCT00228254|"~     Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that~     could help them fight off infections like pneumonia. Our study was designed to see if~     children who got supplements of zinc or vitamin A had fewer infections.~   "
253870|NCT00228241|"~     1. Background - Pacemaker treatment gives asynchronous activation of the heart that often~          results in decreased heart function and clinical heart failure. New pacemaker types that~          stimulates both left and right ventricle ( biventricular pacemakers ) is introduced to~          the treatment of patients with heart failure, decreased left ventricular function and~          ECG signs with left bundle branch block.~        2. Hypothesis - Ventricular pacing results in remodelling of the left ventricle and~          decreased left ventricular function. Biventricular pacing do not do this. Ventricular~          pacing results in heart failure and increased wall stress with decreased 6 minutes walk~          test and increased BNP in blood samples. This is not seen by biventricular pacing.~        3. Materials and methods - 3 studies. All patients are examined by echocardiography~          2-dimensional, M-mode, 3-dimensional and with tissue harmonic imaging. Study 1) Patients~          with AV-conduction disorder that needs pacemaker treatment are randomized to~          DDD-pacemaker or biventricular pacemaker. Study 2) Patients with sick sinus syndrome~          included in DANPACE are randomized to AAI- or DDD-pacemaker. Study 3 ) Acute study to~          examine the changes in patients AV-block before DDD-pacemaker implantation and after~          implantation.~   "
253871|NCT00228228|"~     In the present study, we, the investigators at Sheba Medical Center, intend to evaluate T~     cell vaccination (TCV) in patients with probable multiple sclerosis (MS) within up to 3~     months after the first clinical attack. It is of the utmost importance to evaluate the~     treatment effects at the onset of disease, i.e. in patients with probable MS, in order to~     evaluate whether early treatment can prevent the second attack (conversion to definite MS).~     Moreover, at disease onset, the immunological process of epitope spreading associated with~     the exposure of the immune system to myelin antigens is still limited. With additional~     attacks, increased recognition of new self-determinants of encephalitogenic peptides~     presented to the immune system during the inflammatory process occurs, and enhances further~     disease activity. The aim of the early TCV treatment approach is to stop this process as~     early as possible, during the onset of the disease, thus preventing additional attacks and~     disease progression.~      We will evaluate the effect of TCV on clinical, immunological and magnetic resonance imaging~     (MRI) parameters in patients with probable MS.~   "
253872|NCT00228215|"~     A randomized controlled trial design will be used to answer whether a behavioral-educational~     sleep intervention and support from a nurse in the immediate postpartum improves maternal and~     infant sleep 6 weeks later.~   "
253873|NCT00228202|"~     The researchers select 100 cytomegalovirus (CMV) DNA samples from patients diagnosed with CMV~     infection. Patients include bone marrow transplant patients, pregnant women and newborns. The~     researchers determine viral load by real-time polymerase chain reaction (PCR). They amplify~     CMV-gB sequences by PCR and type by sequencing and restriction fragment length polymorphism~     (RFLP). The researchers obtain clinical data from patients' records. They examine association~     between patients' clinical status and CMV-gB genotype and viral load.~   "
253934|NCT00227318|"~     The purpose of this study is to determine the effectiveness of candesartan cilexetil in~     preventing hypertension in people with high normal blood pressure. Patients will be~     randomized to either Candesartan or placebo for an initial 2-year period followed by a second~     2-year period of placebo for all patients.~   "
253874|NCT00228189|"~     Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As~     such they are currently used in clinical vaccination protocols in cancer patients. We~     evaluate the ability of mature DCs pulsed with carcinoembryonic antigen (CEA)-peptide (arm A)~     or electroporated with CEA-mRNA (arm B) to induce CEA-specific T cell responses in patients~     with resectable liver metastases from colorectal cancer. To evaluate immune responses,~     CEA-specific T cell reactivity is monitored in peripheral blood, resected abdominal lymph~     nodes, tumor tissue and biopsies of vaccination sites and post-treatment DTH skin tests.~     Patients are vaccinated intradermally and intravenously with CEA-peptide pulsed mature DCs~     three times prior to resection of liver metastases. In 2007 a side-study has been added (arm~     C), in which patients with stage III or high-risk stage II colorectal cancer that are~     amenable for standard adjuvant oxaliplatin/capecitabine therapy are vaccinated with~     CEApeptide-pulsed DCs. Also in this group, safety and immune responses in peripheral blood~     and the DTH-skin test are the primary endpoints. Results are compared with the results~     obtained in arm A.~   "
253875|NCT00228176|"~     Objectives:~        -  Primary: To evaluate the effect of rimonabant 20-mg once daily in comparison with~          placebo, on the quantitative progression of atherosclerosis as assessed by carotid~          artery intima-media thickness (CIMT)~        -  Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in~          the study population of atherosclerosis patients.~   "
253876|NCT00228163|"~     The primary objective is to assess the long-term safety of teriflunomide in multiple~     sclerosis subjects. The secondary objective is to assess the long-term efficacy.~   "
253877|NCT00228150|"~     The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the~     progression of Parkinson symptoms in patients with early PD. The primary outcome will be the~     time to progression of disability warranting initiation of L-dopa or a dopamine agonist.~     Secondary outcomes will comprise assessments of symptoms, activities of daily living and~     global clinical status.~   "
253878|NCT00228137|"~     The purpose of this study is to compare the functional outcome of two different total knee~     prostheses in a prospective randomised study.~   "
253879|NCT00228124|"~     The purpose of this study is to determine, in patients entered on the National Cancer~     Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation,~     whether the rates of osteoporosis, fractures, and alteration in body composition are reduced~     by intermittent androgen ablation.~      There will be two groups of patients:~        1. A cross-sectional group of 150 patients registered in PR.7 prior to January 1, 2002,~          randomized between intermittent androgen suppression (IAS) and continuous androgen~          suppression (CAS) (75 from each group). Patients who have definite bone metastases are~          excluded from this study. Biochemical failure does not exclude the patient.~        2. A longitudinal study of 150 newly accrued patients randomized between IAS and CAS (75~          from each group). These patients will have baseline evaluation of bone loss and body~          composition, longitudinal monitoring and follow-up on an annual basis for patients on~          CAS and at the end of each “off cycle” of IAS. Patients taking bisphosphonates are~          excluded from this study.~   "
253880|NCT00228111|"~     The aim of this study is to establish the additional effectiveness and costs of routine~     thoraco-abdominal computed tomography (CT) in blunt trauma patients versus conventional~     radiological imaging and to determine which clinical parameters predict a high additional~     value of routine thoraco-abdominal CT.~   "
253881|NCT00228098|"~     Patients with stroke or transient ischemic attach should receive advise on smoking cessation.~     It is however unknown if an intensive smoking cessation program is better than ordinary~     advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.~      The aim of the study was to assess if an intensive smoking cessation program made more~     patients stop smoking after stroke or transient ischemic attack.~   "
253882|NCT00228085|"~     CNS reorganization is evidenced in patients with CNS lesion, no exception to the patients~     with spinal cord injury. The paraplegics have to increase their loading of upper extremities~     to compesate the lost function of lower extremities. We hypothesize that CNS reorganization~     can happen in the chronic paraplegics. We try to compare the changes of parameters of~     transcranial magnetic stimulation in these patients with the normal population~     cross-sectionally.~   "
253883|NCT00228072|"~     The purpose of this study is to determine if suction-curettage of the axilla is favorable in~     regard to effect, recovery and cosmetic appearance compared to standard surgical excision of~     the skin of the axilla in case of excessive sweating.~   "
253884|NCT00228059|"~     This extension study is designed to investigate the long-term safety and tolerability of~     licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind~     study CLIC477D2301.~   "
253885|NCT00228046|"~     This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant~     treatment is more effective than stimulant treatment alone in reducing aggressive behavior~     among children with attention deficit hyperactivity disorder (ADHD).~   "
253886|NCT00228033|"~     This study will evaluate the effectiveness of taking supplemental calcium while pregnant in~     reducing the risk of postpartum depression.~   "
253887|NCT00228020|"~     The aim of this study is assess the safety and efficacy of the treatment regimen of~     basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to~     cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute~     rejection episode or treatment failure during the first 6 months post-transplantation in~     pediatric renal allograft recipients.~   "
253888|NCT00228007|"~     This study will evaluate the effectiveness of antidepressant medication treatment in reducing~     HIV risk behaviors in intravenous drug users with depression.~   "
253889|NCT00227994|"~     This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors~     in improving cognitive function and overall rehabilitation in elderly stroke survivors.~   "
253890|NCT00227981|"~     This study will evaluate the effectiveness of maintenance interpersonal psychotherapy (IPT)~     in preventing relapse of depression in women who have required combined psychotherapy and~     pharmacotherapy treatment to obtain a remission of depression symptoms.~   "
253891|NCT00227968|"~     This study will evaluate the effectiveness of interpersonal and social rhythm therapy (IPSRT)~     versus clinical status and symptom response therapy (CSSRT) in reinforcing the treatment of~     bipolar disorder in individuals who are currently undergoing medication treatment for the~     disorder.~   "
253897|NCT00227890|"~     This study will focus on treating substance abusing incarcerated teens using individually~     administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy~     (CBT). The control group receives individualized Relaxation Training (RT) followed by group~     Treatment as Usual (TU). Currently, there is little research regarding effective group~     treatments for incarcerated teens and this study will address this gap in our knowledge base.~     We seek to reduce substance use and associated risky behaviors post-release (including~     driving under the influence, risky sexual behaviors, etc.).~   "
253898|NCT00227877|"~     The purpose of this study is to test the effectiveness of a brief intervention for alcohol~     and drug use in adolescents that a primary care doctor can give in his/her office. The study~     will be conducted in nine primary care offices in three New England states, and in ten~     pediatric offices in Prague, Czech Republic (CZR).~      We hypothesize that:~        1. Among 12-18 year old well care patients who screen positive for drug/alcohol use, the~          experimental intervention administered by trained primary care providers will be more~          effective than standard care in decreasing drug and alcohol use;~        2. Among 12-18 year old well care patients who screen negative for drug/alcohol use, the~          experimental intervention administered by trained primary care providers will be more~          effective than standard care in decreasing initiation of drug and alcohol use as~          measured by self-reports of substance use;~        3. Among 12-18 year old well care patients who are at risk for driving/riding while~          impaired (DRWI), the experimental intervention administered by trained primary care~          providers will be more effective than standard care in decreasing DRWI risk behavior as~          measured by a standardized scale.~   "
253899|NCT00227864|"~     The purpose of this study is to examine the efficacy of a brief motivational intervention on~     marijuana use and sex-risk behavior in young women.~   "
253900|NCT00227838|"~     The purpose of this study is to modify Integrated Group Therapy (IGT), which is has been~     found successful for patients with bipolar disorder (BD) and substance use disorder(SUD), so~     that it can be more readily adopted by community drug abuse treatment programs. IGT is being~     reduced from 20 to 12 sessions in this trial, and is being conducted by front-line drug~     counselors, to test its effectiveness in a more community-based setting. The training has~     been expanded so that counselors without much psychopathology training or cognitive~     behavioral therapy experience can conduct IGT.~   "
253901|NCT00227825|"~     The purpose of this study is to conduct a pilot study of Motivational Enhancement Therapy~     (MET), an empirically validated behavioral change strategy, with young adults who are HIV +.~     The aim is to determine if MET is effective in increasing general health promotion behaviors,~     adherence to HIV+ specific medical treatment over and above taking medication, and decreasing~     risky behaviors in young adults who are HIV positive. The longer-term objective is to~     identify and way to decrease HIV transmission rates, disease progression, illness episodes,~     and hospitalizations in this high-risk population.~      Hypotheses: 1)Youth receiving the motivational intervention plus referrals will report~     greater reductions in risky behaviors than youth in the control group receiving standard care~     plus referrals at 3-months post-baseline. This hypothesis will first be tested in the whole~     sample using an overall risk index. Then, the hypothesis will be tested with each behavior~     (reduced drug and alcohol use, condom use, taking medications,) within the subgroups~     reporting problem levels of that behavior; 2)Youth in the intervention group will demonstrate~     improved viral loads, will report greater improvement in perceived health status, depression,~     general psychological distress, disclosure to sexual partners, and will demonstrate greater~     attendance of medical and support service appointments than youth in the control group at 3~     months post-baseline; 3)Youth in the intervention group will report greater reductions in~     temptation to engage in risky behaviors, increased self-efficacy, and improvements in~     readiness to change their behavior than youth in the control group at 3 months post-baseline;~     4)The differences between the intervention and control group from pre- to post- intervention~     will be maintained at 6, 9, 12, and 15 months post-baseline (3, 6, 9, and 12 months after~     intervention completion).~   "
253902|NCT00227812|"~     The purpose of this study is to test whether cognitive behavioral therapy and bupropion~     hydrochloride will help cocaine users, who are depressed, reduce or end their cocaine use and~     improve their mood.~   "
253903|NCT00227786|"~     RATIONALE: Stop-smoking plans suggested by physicians may help patients quit smoking.~     Studying how physicians give stop-smoking treatment as family doctors may increase the chance~     of smokers receiving such treatment.~      PURPOSE: This randomized clinical trial is studying physicians' practice patterns to see if~     regular feedback to the physician increases the chance of adult smokers receiving~     stop-smoking treatment.~   "
253904|NCT00227773|"~     RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control~     symptoms, such as diarrhea, caused by the tumor. Giving vatalanib together with octreotide~     may be an effective treatment for neuroendocrine tumors.~      PURPOSE: This phase II trial is studying how well giving vatalanib together with octreotide~     works in treating patients with progressive neuroendocrine tumors.~   "
253905|NCT00227760|"~     This phase II trial studies how well cediranib maleate works in treating patients with~     recurrent or metastatic kidney cancer that cannot be removed by surgery. Cediranib maleate~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
253906|NCT00227747|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving more~     than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy~     together with combination chemotherapy before surgery may shrink the tumor so it can be~     removed. It is not yet known whether giving radiation therapy together with capecitabine is~     more effective with or without oxaliplatin before surgery in treating rectal cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and~     oxaliplatin to see how well they work compared to radiation therapy and capecitabine in~     treating patients who are undergoing surgery for stage II or stage III rectal cancer.~   "
253907|NCT00227734|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether giving capecitabine and oxaliplatin together with cetuximab is more effective than~     capecitabine and oxaliplatin in treating colorectal cancer.~      PURPOSE: This randomized phase II trial is studying how well giving capecitabine and~     oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in~     treating patients with metastatic colorectal cancer that cannot be removed by surgery.~   "
253908|NCT00227721|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel~     works in treating patients with relapsed or refractory ovarian epithelial or peritoneal~     cancer.~   "
253909|NCT00227708|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Chemotherapy drugs may have different effects in older patients.~      PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients~     with locally advanced or metastatic non-small cell lung cancer.~   "
253910|NCT00227695|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. It is not yet known whether giving~     rituximab over a short period of time is more effective than giving it over a long period of~     time in treating follicular non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying rituximab to see how well it works when~     given over a short period of time compared to when given over a long period of time in~     treating patients with follicular non-Hodgkin's lymphoma.~   "
253911|NCT00227682|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, dexamethasone, and ascorbic~     acid, work in different ways to stop the growth of cancer cells, either by killing the cells~     or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may~     kill more cancer cells. Sometimes when chemotherapy is given, it does not stop the growth of~     cancer cells. The cancer is said to be resistant to chemotherapy. Giving arsenic trioxide~     together with chemotherapy may reduce drug resistance and allow the cancer cells to be~     killed. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the~     cancer. Giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid~     may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with~     thalidomide, dexamethasone, and ascorbic acid works in treating patients with relapsed or~     refractory multiple myeloma.~   "
253912|NCT00227669|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It~     is not yet known whether giving gemcitabine together with docetaxel is more effective than~     giving gemcitabine alone as second-line therapy in treating uterine or soft tissue~     leiomyosarcoma.~      PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well~     they work compared to gemcitabine alone as second-line therapy in treating patients with~     metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.~   "
253913|NCT00227656|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Pegylated interferon alfa-2a may interfere with the growth of tumor cells. Giving~     capecitabine together with pegylated interferon alfa-2a may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving capecitabine together with pegylated~     interferon alfa-2a works in treating patients with recurrent or progressive brain metastases~     due to breast cancer.~   "
253914|NCT00227630|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it~     can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain~     after surgery.~      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin~     followed by surgery and radiation therapy works in treating patients with malignant pleural~     mesothelioma.~   "
253915|NCT00227617|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab~     may also stop the growth of neuroendocrine tumors by blocking blood flow to the tumor. Giving~     combination chemotherapy together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving combination~     chemotherapy together with bevacizumab and to see how well it works in treating patients with~     advanced neuroendocrine tumors.~   "
253916|NCT00227591|"~     This phase II trial is studying how well giving lenalidomide together with prednisone works~     in treating patients with myelofibrosis. Lenalidomide may stop the growth of myelofibrosis by~     blocking blood flow to the cancer. It may also stimulate the immune system in different ways~     and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving lenalidomide together with prednisone may kill more cancer cells.~   "
253917|NCT00227565|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with~     carboplatin works in treating patients with extensive-stage small cell lung cancer.~   "
253935|NCT00227305|"~     The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate~     (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.~   "
253953|NCT00227071|"~     Compare the effect of aquatic,land and no exercise on fall risk factors in women diagnosed~     with osteoporosis~   "
254018|NCT00226226|"~     The purpose of this study is to test whether peripherally inserted central catheters can be~     safely placed on patients by intravenous team nurses at the bedside.~   "
253918|NCT00227539|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before,~     during, and after chemotherapy) may help doctors predict a patient's response to treatment~     and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving combination chemotherapy after surgery may~     kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well PET works in predicting response in~     patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without~     surgery for stage I, stage II, or stage III non-small cell lung cancer.~   "
253919|NCT00227526|"~     Most patients find that recovering from surgery is difficult particularly after abdominal~     surgery for cancer or other intestinal disorders. The surgical stress, healing process and~     concerns if further treatments are required suggest that the post-operative period may not be~     the best time to get people to exercise to rehabilitate lost functions. Prehabilitation is~     the process of enhancing functional capacity of the individual to enable him or her to~     withstand an incoming stressor, such as surgery, and this study aims to evaluate the~     effectiveness of prehabilitation for colorectal surgery. Two groups will be formed by a~     random process and the prehabilitation group will use an exercise cycle and weights to build~     endurance and strength for a 3-week period prior to surgery. The other group will receive~     training about exercises that will help them move better after surgery. People who are~     malnourished prior to surgery will receive nutritional supplements. The results of this trial~     will be used to inform practitioners and patients alike of the benefits (or risks if any) of~     exercise in preparing for surgery.~   "
253920|NCT00227513|"~     This phase I trial is studying the side effects and best dose of vorinostat and bortezomib in~     treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy,~     such as vorinostat, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with~     bortezomib may kill more tumor cells.~   "
253921|NCT00227500|"~     This study is a randomised, placebo-controlled study of the effect of treatment with the~     HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated~     patients with high serum cholesterol. We hypothesise that pravastatin will result in greater~     reductions in cholesterol than placebo when used in conjunction with appropriate dietary~     advice.~   "
253922|NCT00227487|"~     The purpose of the study is to find correlations between non-invasive fecal tests of~     intestinal inflammation and macro- and microscopic evaluation of duodenal and colonic~     histology, disaccharidase activity, and intestinal permeability in children with autism.~   "
253923|NCT00227474|"~     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective~     immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune~     response and prevent or delay the recurrence of cancer.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients~     with stage IIIB or stage IV breast cancer in remission.~   "
253924|NCT00227461|"~     The study investigates the possibility that levetiracetam may improve the symptoms of chronic~     post-stroke aphasia.~   "
253925|NCT00227448|"~     The ultimate goal of this multicenter, phase II study is to increase blood pressure until~     either a neurologic response is seen or a target mean arterial pressure of 30% above baseline~     is achieved. IV fluids, IV phenylephrine and/or IV norepinephrine are used to rapidly raise~     mean arterial pressure in a controlled manner as serial assessments of neurologic function~     are performed.~   "
253926|NCT00227435|"~     This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral~     activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.~   "
253927|NCT00227422|"~     The purpose of this study is to evaluate that the vaccine produced with the new process and~     administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in~     terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.~   "
253928|NCT00227409|"~     Previous study showed repeated lead chelation therapy significant reduced progressive renal~     insufficiency in patients with chronic renal diseases and high-normal body lead burden in a~     placebo-controlled, randomized, 2-year clinical trial, even factors that influence~     progression, such as blood pressure, the presence or absence of hyperlipidemia, and urinary~     protein excretion were well controlled.Since relative small sample size and short duration of~     follow-up were noted in the previous study, whether repeated lead chelation therapy could~     long-term retard the progression of renal insufficiency remains unknown. Hence, we conducted~     a 51-month placebo-controlled clinical trial to assess the long-term effect of repeated~     chelation in progressive renal insufficiency of patients with high-normal body lead burden.~   "
253929|NCT00227383|"~     In this study, we aim at evaluating the effect of electroacupuncture in diabetic patients~     with gastroparesis. Patient-based symptom severity measure, serum parameters and solid-phase~     gastric emptying time are measured to evaluate the effectiveness of electroacupuncture.~   "
253930|NCT00227370|"~     The study evaluated the efficacy and safety of a prolonged, continuous course of~     Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the~     standard of care upon initiation of the study, to 12 months of Valganciclovir.~   "
253931|NCT00227357|"~     The goal of this study is to develop and evaluate an innovative model of care to better serve~     patients who are both HIV-infected and opioid-dependent.~   "
253932|NCT00227344|"~     The objective of this prospective multicenter randomized study is to establish the~     effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary~     veins with radiofrequency (RF) ablation and creating additional lines of block with the aid~     of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System.~     Effectiveness will be determined by comparing the chronic success of ablation therapy versus~     antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the~     first 24 months after a run-in phase of 2 months.~   "
253933|NCT00227331|"~     This is a clinical trial to determine if oral amoxicillin is equivalent in efficacy to~     injectable penicillin (the standard treatment) in the treatment of WHO-defined severe~     pneumonia in children between the ages of 2 and 59 months.~   "
253936|NCT00227292|"~     Chronic low back pain (CLBP) is one of the most frequent forms of chronic pain and can result~     in significant functional impairment. This is often associated with major depression too.~     Previous research reported significant beneficial effects of antidepressant medication in~     alleviating depression and pain intensity. The aim of this study is to evaluate the efficacy~     of Escitalopram, a new kind of Selective Serotonin Reuptake Inhibitor (SSRI) in patients with~     CLBP in a prospective, randomized and double-blind clinical trial. The main hypothesis is:~      -in comparison to placebo, subjects with CLBP and Cipralex report a significant reduction in~     depressive symptoms (>= 50% of HAMD questionnaire) after 4 weeks of treatment.~   "
253937|NCT00227279|"~     This trial is performed to assess the efficacy and safety of the ALK Grass tablet for~     treatment of grass pollen induced rhinoconjunctivitis (hayfever).~   "
253938|NCT00227266|"~     This is a multi-center trial to assess safety and efficacy of a combined regimen of oral~     valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17~     years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat~     protocol for SMA sitters 2 - 8 years of age. Cohort 2 is an open label protocol for SMA~     standers and walkers 3 - 17 years of age to explore responsiveness of efficacy outcomes.~     Outcome measures will include blood chemistries, functional testing, pulmonary function~     testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative~     assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign~     parameters. Six centers will enroll a total of 90 patients.~   "
253939|NCT00227253|"~     Our vision, that of the researchers at the University of Texas Health Science Center at San~     Antonio, is that every person with a chromosome 18 abnormality will have an autonomous and~     healthy life. Our mission is to provide families affected by chromosome 18 abnormalities with~     comprehensive medical and educational information. Our goals are to provide definitive~     medical and education resources for the families of individuals with chromosome 18~     abnormalities; perform and facilitate groundbreaking clinical and basic research relating to~     the syndromes of chromosome 18; and to provide treatments to help these individuals overcome~     the effects of their chromosome abnormality.~   "
253940|NCT00227240|"~     The purpose of this study is to investigate the incidences of adverse events for patients~     with plaque psoriasis treated with Enbrel under usual care settings.~   "
253941|NCT00227227|"~     The purpose of this study is to investigate the incidence of adverse events for patients with~     AS treated with Enbrel in usual care settings.~   "
253942|NCT00227214|"~     The aim of this study is to determine the prevalence of pneumococcal meningitis in the~     paediatric population in Spain four years after the marketing of Prevenar. Also secondary~     objectives are: 1) to determine the clinical characteristics and outcome of the disease; and~     2) to determine serotypes and antibiotic resistance patterns.~   "
253943|NCT00227201|"~     The objective of this study is to better understand strategies used by African Americans with~     hypertension in order to control their blood pressure.~   "
253944|NCT00227188|"~     The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the~     prevention of IPD in the Spanish paediatric population (children younger than 5 years)~   "
253945|NCT00227175|"~     To explore the meaning, causes and treatment of hypertension in eligible patients. In~     addition the cultural, social, and psychological factors that either facilitate or serve, as~     barriers to behavioral change will be illuminated in this patient population.~   "
253946|NCT00227162|"~     The objective of this pilot study is to assess the feasibility and the potential differential~     impact of a novel intervention of induced positive affect and self-affirmation to increase~     physical activity in asthma patients.~   "
253947|NCT00227149|"~     This is a long-term evaluation follow-up study of neurocognitive performance and emotional~     state in patients with chronic hepatitis C infection and a former (peg)interferon~     alfa-2b-based therapy.~      M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen~      Questions:~        -  Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients~          with chronic hepatitis C - are they fully reversible in long-term follow-up after the~          end of antiviral treatment?~        -  At least 12 months after the end of antiviral treatment - are neurocognitive and~          mood-related parameters even significantly improved as compared to pretreatment values?~          Is this possibly only true of patients with successful virus eradication?~        -  At least 12 months after the end of antiviral treatment, is there a significant~          difference between patients with and without sustained virological response with respect~          to neurocognitive performance, emotional state and quality of life?~        -  In the absence of clinically significant liver damage in patients with chronic hepatitis~          C - does the mere presence of the hepatitis C virus have any significant influence on~          neurocognitive or attentional performance?~        -  Does the study data support an additional indication for antiviral therapy in chronic~          hepatitis C? In the case of successful virus eradication, emotional state and - above~          all - is neurocognitive performance significantly improved even in the absence of severe~          liver damage?~   "
253948|NCT00227136|"~     This is a research study looking at the effect of 5-Hydroxy Tryptophan (5-HTP) on urine~     excretion of 5-Hydroxyindolacetic acid (5-HIAA). 5-HTP is a common over the counter product~     that is sold in natural food stores and via the Internet. Increased levels of 5-HIAA in the~     urine can be found in a specific type of cancer, called carcinoid tumor. This study will~     examine the effect of oral 5-HTP intake on 5-HIAA excretion. Understanding this effect may~     help to determine which tests should be done in a patient with increased 5-HIAA excretion~     who's also taking 5-HTP.~   "
253949|NCT00227123|"~     The purpose of this study is to determine whether quetiapine or risperidone are effective in~     treating mood symptoms, drug cravings and use in bipolar disorder with concurrent cocaine or~     methamphetamine dependence.~   "
253950|NCT00227110|"~     To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH)~     in patients with glucose intolerance or type 2 diabetes mellitus (T2DM).~   "
253951|NCT00227097|"~     The objective of the project Educ'Avk, is to document the efficacy of a strategy combining~     a specific follow up-notebook and education of attending patient with a pedagogic support,~     comparatively to an usual education on the impact of clinical events at three months (minor~     or major hemorrhagic events + recurrence of thrombi-embolic's disease).~   "
253954|NCT00227058|"~     The purpose of this study is to learn if two nutritional supplements, Orotic Acid and~     Glutathione will have any effect on the immune system response and if there will be any~     effect on the symptoms of seasonal allergies. It is our thinking that they will have an~     positive effect.~   "
253955|NCT00227045|"~     The objective of this study is to determine the extent and magnitude of the pharmacokinetic~     drug interaction between mycophenolate mofetil (MFF) (under Css conditions) in the presence~     of iron in renal transplant recipients.~      A two phase pharmacokinetic study will be conducted to determine the bioavailability of MMF~     (under steady state, Css, conditions) in the presence of two commonly prescribed iron~     formulations (polysaccharide iron complex and sustained release ferrous sulfate) in renal~     transplant recipients. This study will evaluate valuable clinical information to help better~     guide the appropriate utilization of the following formulations and dosing strategies:~        1. Polysaccharide iron complex concomitant administration with MMF,~        2. Sustained release ferrous sulfate concomitant administration with MMF,~        3. Dose separation (2 hours) between MMF and iron (polysaccharide iron complex or sustained~          release [S.R.] ferrous sulfate)~   "
253956|NCT00227032|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib in~     treating patients with progressive glioblastoma multiforme.~   "
253957|NCT00227019|"~     This trial evaluated the safety of combining bevacizumab and pemetrexed in non-small cell~     lung cancer (NSCLC) patients with stable brain metastases as second-line chemotherapy, while~     evaluating progression-free survival (PFS) and overall survival (OS).~   "
253958|NCT00227006|"~     Once intervention class or staff contact is removed, obese adults participating in behavioral~     weight-loss programs often give up healthy eating habits and regain weight. We examined~     whether taste-based goal setting, which minimizes perceived deprivation by promoting taste~     and moderation, would sustain long-term reductions in saturated fat and body mass index~     (BMI).~   "
253959|NCT00226993|"~     This is a single institution phase I / II trial to evaluate the safety and efficacy of~     intratumoral CpG injections combined with local radiation in patients with mycosis fungoides.~     Patients will receive low-dose radiotherapy to a single tumor site on days 1 and 2 (2 Gy each~     day). CpG injections will be administered into the same tumor site within 24 hours before or~     24 hours after each radiation treatment. Weekly doses of (intratumoral or peritumoral~     injections) CpG will be then administered subcutaneously in the region of previous injections~     for 23 additional doses. The total treatment duration is 24 weeks.~   "
253960|NCT00226980|"~     The purpose of this study is to determine the efficacy of the combination of thalidomide and~     capecitabine in metastatic renal cell carcinoma and also to determine the safety of the~     combination.~   "
253961|NCT00226967|"~     The purpose of this study is to learn about the effects of stress on hormones, the~     relationship between these hormones and cancer progression.~   "
253962|NCT00226954|"~     Primary:~      To determine the duration of use of zoledronic acid in improving Bone mineral density in~     patients with prostate cancer who are on hormones intermittently.~      Secondary Objectives:~      To describe the safety and tolerability at this dose and schedule~   "
253963|NCT00226941|"~     The objectives of this study are to:~        1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a~          combination regimen with capecitabine and radiotherapy (Phase 1)~        2. To determine the maximum-tolerated dose (MTD) when capecitabine~             -  oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)~        3. To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination~          with capecitabine and radiotherapy (Phase 2)~   "
253964|NCT00226928|"~     This study will investigate the influence of psychosocial treatment on psychological outcomes~     and survival among women with metastatic or recurrent breast cancer.~   "
253965|NCT00226915|"~     The purpose of the study is to compare progression-free survival of conventional paclitaxel~     and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage~     II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.~   "
253966|NCT00226902|"~     Dialysis patients suffer from many problems with blood vessels and this is even more so for~     patients with the added complication of diabetes. Diabetics have a number of reasons for~     vascular disease and one of the new areas of research is looking at the cells that line the~     blood vessels, called endothelial cells. It is thought that the number of red blood cells in~     the blood (haemoglobin concentration) affects the function of these cells. There is very~     little information available on what haemoglobin level is best for dialysis patients. As~     diabetics account for almost 40% of dialysis patients worldwide it is important to understand~     the effect different haemoglobin levels will have on the blood vessels.~      Hypothesis: Endothelial cell function and the related expansile capacity of blood vessels are~     affected by different haemoglobin concentrations [Hb] in dialysis patients.~   "
253967|NCT00226889|"~     Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are~     capable of inhibiting fibroblast activity may be beneficial if administrered early in the~     disease course. Thirty adult patients with early SSc will be treated with the endothelin-1~     antagonist bosentan for 6 months.Disease progression will be assessed.~   "
253968|NCT00226876|"~     Patients commonly report that they have been dreaming when they awaken from general~     anaesthesia. Our hypothesis is that patients who report dreaming are less deeply~     anaesthetised during anaesthesia than patients who do not report dreaming. Depth of~     anaesthesia will be determined using a processed electroencephalographic monitor (called the~     BIS monitor).~   "
253969|NCT00226863|"~     This study examined whether meditation or group psychotherapy including hypnosis plus~     education, compared to an educational control, would ameliorate long-term depressed mood.~   "
253970|NCT00226850|"~     This study examined whether a hypnosis intervention, compared to standard care, could help~     reduce distress and pain for children undergoing an invasive medical procedure.~   "
253971|NCT00226837|"~     Our hypothesis is that a new method of depth of anaesthesia monitoring, using theoretically~     based time series modelling will result in improved ability to determine nitrous oxide~     anaesthetic effect~   "
254019|NCT00226213|"~     The purpose of the study is to perform the first clinical trial on human subjects using the~     Sonic Flashlight (SF) to guide placement of Peripherally Inserted Central Catheters (PICCs).~   "
253973|NCT00226811|"~     The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2~     step design) after which Step 2 was opened and the total enrollment target for the study~     (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study~     did not open due to the final overall insufficiency of efficacy observed in 78 patients.~     Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a~     starting dose of 50 mg with provision for dose reduction based on tolerability. All patients~     received repeated cycles of sunitinib until disease progression, occurrence of unacceptable~     toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients~     were followed up in order to collect information on further antineoplastic therapy and~     survival.~   "
253974|NCT00226798|"~     Immunochemotherapy consisting of IL-2, INF-A, and VBL and 5FU is regarded as the treatment of~     choice in metastatic renal cell carcinoma. During the period 1996-2000, we evaluated the~     efficacy and toxicity of this immunochemotherapy, combined with an aggressive surgical~     approach: nephrectomy before treatment and resection of residual disease. The 3-year survival~     rate for the entire group and complete responder patients was 30% and 88%, respectively. The~     side effects were usually moderate and consisted mainly of a flu-like syndrome, headache,~     nausea, vomiting and depression. Most importantly, there was no drug-related death. Good~     performance status, absence of bone metastases and prior nephrectomy were associated with~     higher response rates.~      Capecitabine is a novel fluoropyrimidine carbamate, orally administered and selectively~     activated to Fluorouracil by a sequential triple-enzyme pathway in liver and tumor cells.~     Capecitabine at dose of 2,500mg/m2/d divided equally into two daily doses for 14 days in~     patients who failed to respond to “standard” immunotherapy achieved a 30% objective response.~     Toxicity consisted of hand-foot syndrome.~      Aim of Study:~      To evaluate efficacy and toxicity of the combination of IL-2, INF-A, VBL and Capecitabine in~     MRCC~   "
253975|NCT00226785|"~     The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice~     sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of~     sedation in long-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared~     with current best practice, reduces the length of ICU stay.~   "
253976|NCT00226772|"~     The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic~     surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma~     initiates an acute inflammatory response, including swelling and pain, that leads to~     restricted joint motion and loss of function. OMS103HP was designed to deliver targeted~     therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit~     inflammation and pain before they can begin.~      The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving~     knee function following ACL reconstruction using a hamstring autograft. Secondary benefits~     being evaluated include reduced postoperative pain, improvement in knee range of motion, and~     earlier return to work.~   "
253977|NCT00226759|"~     The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic~     surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma~     initiates an acute inflammatory response, including swelling and pain, that leads to~     restricted joint motion and loss of function. OMS103HP was designed to deliver targeted~     therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit~     inflammation and pain before they can begin.~      The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving~     knee function following ACL reconstruction. Secondary benefits being evaluated include~     reduced postoperative pain, improvement in knee range of motion and earlier return to work.~   "
253978|NCT00226746|"~     The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs~     gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation~     treatment on locally advanced pancreatic cancer.~   "
253979|NCT00226733|"~     The purpose of this study is to investigate the effect of high and moderate intensity~     exercise training after coronary bypass surgery. The subjects are randomised to training at~     either 60-70% or 85-95% of their maximal capacity daily for four weeks. Primary outcome~     measure is change in maximal aerobic capacity, measured as change in maximal oxygen~     consumption, after the training period. Secondary outcome measures are change in quality of~     life, heart rate variability, ultrasound measures of the heart and blood variables, including~     endothelian markers.~   "
253980|NCT00226720|"~     Detoxification, in an inpatient or outpatient program, is the primary and essential step for~     managing alcohol dependence. The superiority of one or other method of detoxification has~     never been proved in several previous randomized clinical trials (RCT). The aim of this~     multicenter RCT was to compare efficiency, on the abstinence rate as the primary outcome, at~     1 and 3 months follow-up of two alcohol detoxification programs (a 5/7-days inpatient detox~     vs. an ambulatory detox).~   "
253981|NCT00226707|"~     Topical steroids are standard of care for Chronic Hand Dermatitis, but long-term use is~     associated with adverse effects. This study will assess the efficacy and safety of~     pimecrolimus cream 1% in patients with mild-to-moderate chronic hand dermatitis.~   "
253982|NCT00226694|"~     The purpose of this study is to look at the stress hormone response to medication-induced~     stress and a placebo (an inactive compound) in non-drinking, recovering male and female~     alcoholics, with a specific emphasis on the differences between men and women in the two~     recovering alcoholic groups.~   "
253983|NCT00226681|"~     To determine if an education and support nursing intervention program helped sudden cardiac~     arrest survivors adjust to the event and to getting an ICD~   "
253984|NCT00226668|"~     The purpose of this study is to examine the safety and efficacy of XERECEPT (human~     Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary~     malignant glioma who require increased dexamethasone doses to control symptom of peritumoral~     brain edema.~   "
253985|NCT00226655|"~     The purpose of this study is to examine the long-term safety and tolerability of human~     corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone~     (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to~     all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other~     designated studies, including patients who may have discontinued blinded study medication~     early but completed the protocol-stipulated follow-up periods.~   "
253986|NCT00226642|"~     The purpose of this study is to determine the efficacy of a SSRI,~     cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary~     care patients suffering from mild to moderate depression.~      Hypotheses:~        -  SSRI is superior to placebo~        -  CBT is superior to a non-specific supporting group therapy~   "
253987|NCT00226629|"~     The purpose of this study is to compare the cost effectiveness, quality of life and outcomes~     of the endovascular stent graft repair with the open surgical repair of abdominal aortic~     aneurysms.~   "
253988|NCT00226616|"~     Cholera is one of the leading causes of morbidity and mortality among children and adult in~     developing countries. We will evaluate the effect of supplementation of zinc on reduction of~     duration and severity of cholera. Since cholera is primarily a disease of older children and~     adults, we intend to study the effects of zinc supplementation among children of 3 to 14~     years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field~     examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea~     for less than 24 hours will be selected. After inclusion in the study, informed consent will~     be obtained from guardian explaining the full procedure in the hospital. The subjects will be~     randomized to receive either zinc or placebo until diarrhea resolves. History of illness and~     baseline information will be collected in the hospital through interview, which may take~     duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be~     carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample~     will be taken to assess serum zinc level on admission after initial hydration and will be~     repeated on the day of recovery. This procedure carries a small risk of infection if not done~     under sanitary conditions; however, we will maintain proper sanitation, so there is no risk~     in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given~     daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet~     Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous~     acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be~     sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of~     random stool samples. Information obtained from history and the laboratory investigations of~     subject will be kept strictly confidential and no one other than the investigators of this~     study and the Ethics Committee of this Centre will/ has access to the information. The study~     will benefit the patients as study physician will do close observation, examination and will~     take care frequently, as research staff will monitor systematic progress and take necessary~     action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If~     the results of the study is positive, it will benefit the patients in their treatment during~     this study and thereafter. The data will be analyzed for clinical effects of zinc on~     diarrhea.The study will help to improve the treatment strategy of cholera in children. The~     study will use hospital records, which will be returned after completion of the study. Stool,~     urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.~   "
253989|NCT00226603|"~     To examine the effect of a specific training programme towards groin injuries in male footbal~     players. To evaluate the effect on other football related injuries as well. To examine any~     possible relations between various possible predictors such as experience, age, hypermobility~     and others, and the risk of sustaining inujries during football.~   "
253990|NCT00226590|"~     This is a single institution Phase II study for patients with unresectable Stage IIIA and~     IIIB non-small cell lung cancer. The treatment started with 2 cycles of gemcitabine and~     carboplatin followed by concurrent chemotherapy with radiation. The chemoradiation included~     using paclitaxel and carboplatin with daily thoracic radiation to a total dose of 74 Gy.~     Response rate was determined following the chemotherapy with gemcitabine and carboplatin and~     evaluated again after the chemoradiation. Treatment toxicities were also assessed.~   "
253991|NCT00226577|"~     This study will evaluate the efficacy and safety of chemotherapy given prior to having lung~     cancer surgically removed. Patients with resectable non-small cell lung cancer will receive~     gemcitabine and pemetrexed together for 4 times biweekly. Patients will be seen by a medical~     oncologist prior to each cycle of chemotherapy given. The medical oncologist will review~     patient's bloodwork and symptoms prior to approving next cycle of chemotherapy. All patients~     will then be evaluated with scans to determine response to chemotherapy and to determine if~     patient is a surgical candidate. These patients will then proceed to surgery to have the lung~     cancer removed. Follow up visits include bloodwork, scans, and a visit with the medical~     oncologist every three months for two years, then every six months for three years to monitor~     for disease recurrence.~   "
253992|NCT00226564|"~     The response to opioids varies greatly among individuals. Some of these variability is~     accounted for by genetic factors.~      The present study was designed to evaluate the possibility that genetic polymorphism in the~     gene encoding for mu opioid receptor may explain variability in the response to alfentanil~     during lithotripsy.~   "
253993|NCT00226551|"~     Single nucleotide polymorphisms at codon 46 and 79 of the gene encoding for the ß2 adrenergic~     receptor (ß2AR) modify its pharmacological properties and may alter the response to ß2AR~     agonists. The goal of the present study was to evaluate the role played by the Arg16Gly and~     Gln27Glu polymorphisms on isoproterenol induced relaxation of internal mammary arteries~     segments ex-vivo.~      Internal mammary leftover segments were collected from 96 patients undergoing coronary artery~     bypass graft operation. Four rings that were prepared from each specimen were allowed to~     reach equilibrium with physiological Krebs solution prior to precontraction with U46619.~     Using the organ bath technique, cumulative dose response curve of isoproterenol was~     constructed and mean EC50 calculated for each patient.~   "
253994|NCT00226538|"~     CYP2C9, is one of the major drug metabolism enzymes accounting for about 20% of the hepatic~     cytochrome P450 content and being second only to CYP3A4.~      The proposed study will explore different possible drug interactions with CYP2C9 substrates~     by evaluating the effect of prototype inducers and inhibitors on the phenotypic trait~     measurement. It is expected that the identification of drugs that might interact with CYP2C9~     substrates will be used to rationalize future drug interaction studies designed to evaluate~     the actual magnitude of effect and its clinical implications. This approach should be~     particularly useful when applied to those CYP2C9 drugs characterized by a narrow therapeutic~     index (i.e. warfarin).~      This study will consist of three study periods separated from each other by a two weeks~     washout period. In the course of the study the subjects will receive in a double blind,~     crossover fashion, rifampin 300 mg. twice daily, diclofenac 50 mg twice daily. and~     fluconazole 200 mg. twice daily, each for one week. All drugs will be administered as~     identical looking tablets that will be prepared at the pharmacy of the Hadassah University~     Hospital and their order of administration will be randomized.On the day prior to, on day 6~     of and 7 days following each drug period, the activity of CYP2C9 will be evaluated by the~     administration of a single phenytoin 300 mg. dose. The subjects will be requested to collect~     their urine for 24 hours and a single blood sample will be obtained 12 hours post phenytoin~     intake.~   "
253995|NCT00226525|"~     This trial is intended to find wether there is a connection between allergy to metals and~     reooclusion of stents in the coronary arteries~   "
254221|NCT00223535|"~     The purpose of this study is to examine whether patients who participate in cognitive~     remediation prior to a skills training program learn and perform the skills better than~     patients who do not participate in cognitive remediation.~   "
253996|NCT00226512|"~     Multi-institutional randomized phase III trial of a non-myeloablative preparative regimen~     with fludarabine and busulfex with or without anti-lymphocyte antibodies (monoclonal~     humanized Campath-1H administered s.c. or polyclonal rabbit anti-T lymphocyte antibodies~     (ATG), combined with low dose and short course cyclosporine A (CSA) and methotrexate (MTX) as~     the sole agent for prevention of graft-vs-host disease (GVHD) for patients with acute~     myelogenous leukemia or myelodysplastic syndrome undergoing allogeneic stem cell~     transplantation from an HLA compatible donor.~   "
253997|NCT00226499|"~     An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella~     vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in~     the prevention of varicella disease in children. The Protocol Posting has been updated in~     order to comply with the FDA Amendment Act, Sep 2007.~   "
253998|NCT00226486|"~     Falls and injurious falls are common among elderly people. The aim of the study is to test a~     model of multifactorial fall intervention in a Danish population of elderly sustaining a~     fall. Focus is on prevention of further falls, patients views on fall prevention and a~     cost-effectiveness analysis.~   "
253999|NCT00226473|"~     The purpose of this multicenter study is to examine whether the proposed randomized treatment~     regime results in a significantly longer survival time and higher quality of life than any~     additionally applied multiple chemotherapy according to the CVD- scheme. So far neither~     established treatment regimes nor reliable data exist for the second-line chemotherapy of~     metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple~     chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not~     only a higher toxicity but show rarely a response rate higher than 10%.~   "
254000|NCT00226460|"~     The purpose of this study was to evaluate the differences in safety and efficacy between~     Parkinson's disease patients who either received transplantation of fetal porcine cells or~     placebo treatment.~   "
254001|NCT00226447|"~     The aim is to investigate the best treatment regime of PEG-Intron A and lamivudine~     combination in terms of viral clearance in chronic hepatitis B patients.~   "
254002|NCT00226434|"~     In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV)~     infection is high. Data suggest that aggressive management of HIV infection, which includes~     Anti-Retroviral Therapy (HAART) during treatment of TB, decreases both morbidity and~     mortality. On the other hand, the use of HAART for patients with TB may cause severe~     complications due to drug-drug interactions, and occasionally a temporary exacerbation of~     symptoms. These reactions may be particularly severe when HAART is started soon after the~     start of TB treatment.~      The proposed study aims to determine the optimal time to initiate HAART in previously~     untreated HIV-infected adult patients with TB and low CD4 cell counts.~   "
254003|NCT00226421|"~     The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone~     extended release in opioid-experienced patients with chronic low back pain.~   "
254004|NCT00226408|"~     The study protocol is being conducted to compare intermittent high-dose i.v. administation of~     interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis~     free survival (DMFI) as a primary endpoint.~   "
254005|NCT00226395|"~     The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of~     oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.~   "
254006|NCT00226382|"~     This study is to investigate the HBV DNA suppression (and HBeAg seroconversion among HBeAg~     positive patients) pegylated interferon treatment at 24 weeks after end of treatment among~     patients who have failed anti-viral treatment in the past.~   "
254007|NCT00226369|"~     We conducted a multicenter, randomized, placebo-controlled trial of Cylexin, an inhibitor of~     the attachment of white blood cells to the endothelium. Our study population was neonates and~     infants undergoing hypothermic cardiopulmonary bypass during surgical repair or palliation of~     congenital heart defects.~   "
254008|NCT00226356|"~     This study is being conducted to determine the clinical response rate for the regimen of~     L-methionine, betaine and folate for unipolar depression.~   "
254009|NCT00226343|"~     Obtain information using a randomized treatment to assess the antidepressant and anxiolytic~     efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive~     episodes.~   "
254010|NCT00226330|"~     This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to~     monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in~     patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including~     treatment and follow-up, is 107 weeks.~   "
254011|NCT00226317|"~     A systematic open-label prospective pilot study to assess aripirazole for acute bipolar~     depression, with a secondary assessment of longer-term mood stabilization.~   "
254012|NCT00226304|"~     This study will evaluate the usefulness of two tests in quickly distinguishing whether a~     patient with HIV infection and focal brain lesions (an injury in a specific area of the~     brain) has a rare type of cancer called primary central nervous system lymphoma (PCNSL), or a~     parasitic infection called toxoplasmic encephalitis.~      Toxoplasmic encephalitis is caused by a parasite and can be treated with antibiotics. PCNSL~     (lymphoma of the brain or spinal cord) must be definitively diagnosed with a brain biopsy~     (removal of a small piece of brain tissue), and the treatment is radiation therapy and~     chemotherapy.~      The tests under study for diagnosing PCNSL or toxoplasmic encephalitis are measurement of~     Epstein Barr virus (EBV) DNA in cerebrospinal fluid (CSF) and FDG-PET scan of the brain. EBV~     is often found in the CSF of people with PCNSL. The study also will compare the accuracy of~     two imaging techniques-TI-SPECT and FDG-PET-in distinguishing between toxoplasmosis and~     PCNSL.~      Patients 18 years of age and older who have HIV infection and at least one focal brain lesion~     without a prior history of PCNSL or toxoplasmic encephalitis may be eligible for this study.~     Each candidate is screened with a medical history, physical examination, blood and urine~     tests and MRI scans of the brain.~      Upon entering the study, all participants take medication to treat toxoplasmic encephalitis.~     They undergo lumbar puncture (spinal tap) to obtain CSF for analysis, an FDG-PET scan, and a~     201TI-SPECT scan. For the PET scan, a radioactive substance is injected into an arm, followed~     by scanning in a doughnut-shaped machine similar to a CT scanner. SPECT is similar to PET but~     uses a different radioactive tracer, and the patient lies on a table while the SPECT camera~     rotates around the patient's head. Patients whose test results indicate a low risk for~     lymphoma continue antibiotic therapy for toxoplasmosis. They have repeat MRI scans around 4,~     7, and 14 days after starting the drug to monitor the response to therapy. Antiretroviral~     therapy is initiated in patients who are not already on such a regimen.~      Patients whose test results indicate a high risk for PCNSL have a CT scan to look for~     evidence of lymphoma elsewhere in the body and are referred for consultation with a~     neurosurgeon to discuss undergoing a brain biopsy. The brain biopsy is done in the operating~     room under general anesthesia. A small cut is made in the scalp and a small opening is made~     in the skull over the area of the brain to be biopsied. A needle is placed in the opening in~     the skull and, guided by CT or MRI, moved to the abnormal area of the brain, where a small~     piece of tissue is removed for study under a microscope.~      Patients found to have toxoplasmosis are discharged from the hospital to the care of their~     primary care physician after they are getting better and are tolerating all their~     medications. They return to NIH for follow-up visits about 4 weeks, and 6 months after~     discharge.~      Patients found to have lymphoma are referred to the National Cancer Institute for screening~     for enrollment in a treatment protocol. Patients who are not eligible for a treatment~     protocol are referred back to their primary care physician or for another NIH treatment~     protocol, if one is available. Patients with lymphoma are seen at the NIAID outpatient clinic~     for follow-up visits and laboratory examinations every 3 months for 2 years.~   "
254013|NCT00226291|"~     This study is investigating the effects of an established clinical informationist program~     (evidence-based practice support service in which information professionals with significant~     clinical knowledge bases and advanced information seeking and appraisal skills) on clinical~     decision making at selected critical care units at Vanderbilt University Medical Center~   "
254014|NCT00226278|"~     Patients suffering from Major Depressive Disorder with Psychotic features who have received~     no changes in their medications in the previous two weeks will receive usual treatment of~     antidepressants, antipsychotics and/or mood stabilizers and adjunct therapy using ORG34517.~     The patient will be hospitalized for up to two weeks to monitor their medications and~     progress and will return to the site for periodic assessments.~   "
254015|NCT00226265|"~     The purpose of this study is to determine whether the SF-36 can be administered reliably to~     cardiac surgery patients (two to three days) post-surgery, with the patient answering the~     questions of this survey from a pre-surgical perspective.~   "
254016|NCT00226252|"~     The purpose of this research study is to investigate a manual wheelchair training program to~     improve the way manual wheelchair users push their wheelchairs.~   "
254017|NCT00226239|"~     The purpose of this study is to determine if the addition of a unique targeted agent called~     Cetuximab (also known as C225 and Erbitux) can increase the effectiveness of standard~     treatment with chemotherapy and radiation.~   "
254020|NCT00226200|"~     This study involves a FDA approved drug, Omalizumab, used in the treatment of moderate to~     severe allergic asthma that cannot be controlled by standard treatment. It works on IgE to~     control the allergic reaction. We are looking at the effects on non-allergic asthma. We hope~     to prove that Omalizumab will have the same effect on non-allergic asthmatics as it does~     allergic asthmatics.~   "
254021|NCT00226187|"~     A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in~     breast-fed preterm infants~      Background:~      Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human~     milk and preterm formulas contain DHA and AA, but at lower concentrations than required to~     approximate utero accretion rate.~      Objective:~      To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in~     the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.~      Design:~      A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal~     centers.~      Subjects and methods:~      Infants with birth weight < 1.5 kg are randomized to either an intervention or a control~     group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100~     ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek,~     USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are~     collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for~     fatty acid pattern using high performance liquid chromatography.~   "
254022|NCT00226174|"~     The purpose of this study is to determine whether curcuminoids are effective in the treatment~     of oral lichen planus.~   "
254023|NCT00226161|"~     The purpose of this study is to determine whether laparoscopic inguinal hernia repair leads~     to a lower incidence of chronic pain compared to open herniorrhaphy.~   "
254024|NCT00226148|"~     The purpose of this study is to look at the bonehealing when a molar has been extracted and~     immediately replaced by an implant leaving some defects around the implant.~      The defects are being treated in three different with the hypothesis that the three ways of~     treatment result in equal bonehealing.~   "
254025|NCT00226135|"~     The purpose of this study is to compare lamotrigine with lithium in the long term treatment~     of bipolar disorder in terms of new episode preventive potentials.~   "
254026|NCT00226122|"~     Monosymptomatic nocturnal enuresis, defined as the involuntary loss of urine during the night~     at an age where voluntary bladder control should have been attained and on the background of~     normal urinary tract function, is a rather common disease of childhood with an estimated~     prevalence of 5-10% at tha age of 7 and a spontaneous remission rate of 15% per year.~      The present study consists of two phases; an in-patient phase and an ambulatory phase.~      In the in-patient phase we will examine the regulation of sodium and the circadian rhythm of~     the hormones that affect this regulation in children with enuresis nocturnal and healthy~     children, as well as the impact of indomethacin on renal water and electrolyte excretion.~      In the ambulatory phase we will examine the efficacy and safety of a treatment modality~     consisting of a combination of dDAVP and indomethacin in patients with severe enuresis where~     dDAVP as monotherapy is inadequate.~      A significant number of children with enuresis and nocturnal polyuria do not respond to~     treatment with dDAVP. If a combination treatment with dDAVP and indomethacin proves superior~     to dDAVP alone the regimen could readily be used in those difficult to cure cases of~     enuresis.~   "
254027|NCT00226109|"~     Chronic alcoholics suffer from weak skeletal and cardiac muscle. The investigators have~     discovered a beneficial effect of spironolactone-treatment in that regard. Therefore, a~     double blind placebo controlled study is conducted, to examine the effects of spironolactone~     on cardiac and skeletal muscle-function in chronic alcoholics.~   "
254028|NCT00226096|"~     The purpose of the study is to determine whether lowering high blood pressure levels after~     the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce~     the chances of a person dying or surviving with a long term disability. The study will be~     undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000~     patients.~   "
254029|NCT00226083|"~     We are studying if sickle cell disease blood platelets are larger than normal and how they~     may cause obstruction of blood vessels. We are also trying to study the reasons why large~     platelets are found in patients with sickle cell disease.~   "
254030|NCT00226070|"~     Patients over 65 years do not have a self care ability the surgery benefits them.~      The aim of this study is development of a rehabilitation program based on patients'~     self-rated health.~        1. A cross section study including 600 patients~        2. RCT including 160 patients~   "
254031|NCT00226057|"~     The purpose of this study is to determine if Raptiva will have beneficial effects in the~     treatment of patients with moderate to severe atopic dermatitis.~   "
254032|NCT00226044|"~     The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment~     in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic~     hernia.~   "
254033|NCT00226031|"~     To evaluate the effectiveness of a multifaceted intervention (reminder and educational~     material) in improving the evaluation of osteoporosis follow-up care of post-menopausal women~     with wrist fractures by their primary care physicians. The intervention is directed at~     improving the gap in continuity of care between emergency/fracture clinics and family~     physicians, and reducing knowledge gaps.~   "
254034|NCT00226018|"~     The purpose of this study is to examine the precision, bias and limits of agreement when~     monitoring the neuromuscular block with acceleromyography with and without preload and~     compare the method to the gold standard, mechanomyography.~   "
254035|NCT00226005|"~     The purpose of this research study is to find out if an experimental drug called~     PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.~      In order for tumors to grow and spread to other parts of the body, they need to have a~     growing blood supply. Tumor cells have been shown to produce substances that stimulate the~     abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel~     cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the~     growth of new blood vessels. A drug that interferes with the growth of new blood vessels~     might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients~     and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely,~     it might be possible to stop tumor growth without harming normal tissues.~   "
254036|NCT00225992|"~     In this phase II study besides evaluating for safety, the primary efficacy parameter is to~     evaluate the incidence of patients who have had a response to Trisenox by evidence of~     increased blood counts (red, white, or platelets) and/or by decrease or transfusion~     dependency. The secondary efficacy parameter is the assessment of the tolerability of the new~     dosing schedule.~      Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of~     0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28~     weeks.~   "
254037|NCT00225979|"~     Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma~     causing overproduction of growth hormone which leads to acromegaly. The objective of this~     study is to assess the safety and efficacy of long-acting repeatable formulation of~     octreotide and to compare it to the safety and efficacy of surgery in patients with~     acromegaly who have not had any previous treatment for acromegaly.~   "
254038|NCT00225966|"~     The purpose of this study is assess the long-term safety and effectiveness of the InterStim~     tined lead using a minimally invasive approach.~   "
254039|NCT00225927|"~     The purpose of this study is to determine whether a new surgical technique (radioguided seed~     localization) for localizing nonpalpable breast tumours is better than the standard technique~     (needle localization).~   "
254040|NCT00225914|"~     To evaluate the efficacy, safety, and tolerability of Paroxetine treatment in perimenopausal~     and postmenopausal women who present with menopause-related symptoms after discontinuing~     hormone therapy (HT), in the presence or absence of concomitant symptoms of depression or~     anxiety.~   "
254041|NCT00225901|"~     The purpose of this study is to determine whether recombinant human hepatocyte growth factor~     is safe and effective in the treatment of fulminant and late-onset hepatic failure.~   "
254042|NCT00225888|"~     The purpose of this study is to compare the effect of food photography with group discussions~     to the effect of regular diabetes nutrition care on people's eating habits, satisfaction with~     care, self-care behaviors, and blood sugar levels. We hypothesize that, by photographing all~     meals and snacks (i.e., keeping 'photo journals') and participating in discussions about the~     photographs with peers and a nutritionist, people with diabetes will become aware of their~     behaviors and develop concrete strategies to meet nutritional recommendations.~   "
254043|NCT00225875|"~     The goal of this study is to evaluate the clinical effectiveness of the rituximab at the~     adults with a chronic immune thrombocytopenic purpura (>=6 months of evolution) and severe~     (platelets <= 30x109/L) and candidate to a splenectomy. The objective is to obtain after a~     treatment by the rituximab a satisfactory response to one year, defined by a number of~     platelets higher than 50x109/L and at least 2 times superior with the persistent initial~     figure without treatment during one year after the end of the treatment.~   "
254044|NCT00225862|"~     A 12-week clinical research study to evaluate the tolerability, efficacy and safety of~     ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS~     in the United States.~   "
254045|NCT00225849|"~     The purpose of this study is to investigate the balance between the risks and benefits of~     primary prevention by Aspirin in elderly Japanese patients with one or more~     cerebro/cardiovascular risk factors~   "
254046|NCT00225836|"~     Dysmenorrhoea (menstrual pain) is a common complaint among women, leading to use of~     analgesics, reduced quality of life, and interference with daily activities such as going to~     work or school.~      Transcutaneous electrical nerve stimulation (TENS) is a well established method for treatment~     of pain. Several clinical studies have shown TENS treatment to be effective against~     dysmenorrhoea. A TENS apparatus specifically developed for the treatment of dysmenorrhoea has~     now become commercially available (OVA), but is has not been tested in clinical studies.~      This study will be done to evaluate the clinical utility of treatment with OVA in women with~     primary dysmenorrhoea.~   "
254047|NCT00225823|"~     Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal~     spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory~     disorder of the upper airway that occurs following allergen exposure. The focus of this~     study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered~     by the pollen from trees, grasses, and weeds. Commonly referred to as 'hay fever', it is~     characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery,~     red eyes.~   "
254048|NCT00225810|"~     The primary objective of the clinical trial is the assessment of the acceptability of the new~     Pentasa formulation - PentasaR Sachets in comparison with the reference PentasaR tablets 500~     mg in children with Crohn's disease. After the screening period (which includes medical~     history, physical examination, basic haematology, serum chemistry , urine analysis and stool~     microbiology , PCD Activity Index )patients will receive (visit I) Pentasa sachets 1g or~     Pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose~     2× 1 g of PentasaR Sachets 1 g or PentasaR tablets 500 mg. The formulation of Pentasa will be~     switched at Visit 2, patients will receive the medication for next 4 weeks. Patients will~     record the acceptability of the both forms of the medication.~      In 6 patients from each group (selected by the randomization), stool and urine will be taken~     to assess concentrations of mesalazine and N-acetylmesalazine during Visit 2 and Visit 3.~     Adverse events will be recorded during the whole course of the treatment period.~   "
254049|NCT00225797|"~     The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone~     extended release in non-cancer patients with chronic low back pain.~   "
254050|NCT00225784|"~     This study is designed to establish the safety and efficacy of a combination of Erbitux~     (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.~   "
254067|NCT00225550|"~     N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer~     progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study~     will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a~     protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that~     subjects can tolerate.~   "
254133|NCT00224679|"~     Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk~     for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin~     or Placebo for 4 years. However, the available data are not sufficient to serve as the basis~     for firm recommendations~   "
254051|NCT00225758|"~     Two thirds or more of breast cancers are dependent on estrogen for growth. We use a number of~     estrogen-blocking medicines for treatment of metastatic breast cancer. The treatment response~     to these agents is unpredictable, however, and approximately one-third of patients with~     metastatic breast cancer with receptors for estrogen or progesterone have no benefit from~     hormonal therapy. Nearly all patients with metastatic breast cancer will eventually become~     resistant to hormonal therapy despite the fact that the hormone receptors are still present.~      Some cells make a different class of growth factor receptor called the Epidermal Growth~     Factor Receptor. There is a growing body of experimental evidence showing that breast cancer~     cells that make Epidermal Growth Factor Receptors are more resistant to hormonal therapy and~     have a poorer prognosis. Several investigators have found that the Epidermal Growth Factor~     Receptor can activate the estrogen receptor, even in the presence of estrogen-blocking drugs.~     Growth of these cells can be slowed by blockade of both Epidermal Growth Factor Receptor~     signaling and estrogen-receptor signaling. Lapatinib is a small molecule which can inhibit~     two different forms of the Epidermal Growth Factor Receptor. It has been studied in people~     with a number of different cancers, including breast cancer, and a safe dose and its common~     side effects have been defined.~      Our hypothesis is that the Epidermal Growth Factor Receptor is the dominant receptor pathway~     used by breast cancers in our patients with hormone-resistant tumors. Drugs like lapatinib~     which block several forms of the Epidermal Growth Factor Receptor would best be able to~     reverse resistance to hormonal agents.~   "
254052|NCT00225745|"~     The primary outcome measure for this study is plasma ghrelin level.~   "
254053|NCT00225732|"~     The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative~     hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of~     Caldolor compared to placebo for the treatment of post-operative pain as measured by~     reduction in the requirement for the narcotic analgesic, morphine, post surgery~   "
254054|NCT00225719|"~     Currently available therapies to treat Acute Coronary Syndromes(ACS) have several limitations~     including; the relatively long treatment duration required before apparent significant~     benefit; the inability to achieve reversal of the atherosclerotic process; and poor patient~     compliance due to chronicity of therapy. This study will assess the effects of rHDL compared~     with placebo on indices of atherosclerosis progression and regression as assessed with~     intravascular ultrasound (IVUS) in patients after acute coronary syndromes (ACS).~   "
254055|NCT00225706|"~     The primary objective of this study of Caldolor administered to febrile hospitalized~     pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a~     single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of~     fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a~     target temperature of 98.6ºF [37.0ºC]).~   "
254056|NCT00225693|"~     The study is intended to collect data to evaluate effectiveness and safety of drug eluting~     stent devices in a dose ranging assessment.~   "
254057|NCT00225680|"~     This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug~     Eluting coronary stent with conventional treatment for in-stent restenosis for coronary~     arteries.~   "
254058|NCT00225667|"~     The purpose of this study is to determine whether irbesartan will reduce the rate of~     recurrent atrial high rate episodes and the development of clinical sustained atrial~     fibrillation in patients with hypertension and permanent pacemaker.~   "
254059|NCT00225654|"~     ELUTES is a European multicenter, randomized, controlled, triple-blinded study designed to~     evaluate the ability of the Paclitaxel Eluting V-Flex Plus coronary stent to reduce~     restenosis in the coronary artery.~   "
254060|NCT00225641|"~     The aim is to conduct a prospective multicentre randomised study comparing two different~     control regimens after resection for colorectal cancer stage II - III. Follow-up after~     surgery for colorectal cancer is a controversial issue. The reasons for follow-up are: to~     obtain a better overall survival, for scientific purposes and/or for psychological reasons~     and/or as quality assessment. Meta-analyses of randomised controlled studies have lately~     shown that a beneficial effect on the overall mortality could be found with intense follow-up~     compared to sporadic. This study compares the regimen of CT-scan or MR scan of the liver,~     control of the carcinoembryonic antigen (CEA), and CT-scan or X-ray of the lungs in two~     groups with either control after 12 and 36 months, or after 6, 12, 18, 24, and 36 months. The~     efficacy parameters are total and cancer-specific mortality.~   "
254061|NCT00225628|"~     Assesses physician compliance with paper-based and electronic guidelines, reminders, and~     alerts for outpatient settings. Target areas for the reminders and alerts are disease~     management, medication management, and interpretation of abnormal test results.~   "
254062|NCT00225615|"~     The primary objective of this trial is to evaluate the safety and tolerability of long-term~     Phenoptin treatment in subjects with PKU.~   "
254063|NCT00225602|"~     The aim of the study is to evaluate the effect of assertive community treatment in Copenhagen~     in two regions compared with two regions where this treatment was not implemented. The effect~     on user satisfaction, use of bed days, social network, global assessment of functioning,~     substance misuse will be evaluated.~   "
254064|NCT00225589|"~     The purpose of this trial is to see if rosuvastatin will be effective in decreasing the~     thickness of the walls of the arteries in the neck for people who already have some evidence~     of thickening of these walls.~   "
254065|NCT00225576|"~     To determine the effects of Electronic Health Record use on medication error rates in primary~     care office practices.~      Hypothesis: Adoption of Electronic Health Records through this program will reduce medication~     errors~   "
254066|NCT00225563|"~     The Taconic IPA, a 2,500 physician independent practice association (IPA) located in~     Fishkill, New York (NY), is involved in an information technology project to improve the~     quality, safety and efficiency of healthcare in the region. Over the past three years, the~     organization has worked with area hospitals and laboratories to create a community wide~     electronic data exchange. Currently, the Taconic IPA is in the midst of implementing a full~     electronic health record in some practices and e-prescribing in other practices. The purpose~     is to study the impact of an electronic health record on safety and quality measures.~   "
254191|NCT00223938|"~     This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the~     maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients~     receiving Erythropoietin.~   "
254068|NCT00225537|"~     Open-label studies, anecdotal reports, and in vitro scientific research indicate that~     4-methylumbelliferone (active ingredient of the dietary supplement Heparvit®) may prevent and~     reverse the symptoms and complications of chronic infection with hepatitis B virus (HBV)and~     hepatitis C virus (HCV). This effect has been observed among naïve patients as well as those~     who are non-responders to interferon, commonly used as first-line therapy for HBV and HCV. In~     order to scientifically address the efficacy of this 4-methylumbelliferone on chronic viral~     hepatitis, a randomized, placebo-controlled, blinded study is needed.~      It is hypothesized that 4-methylumbelliferone may reduce the impact and aggressiveness of HBV~     and HCV upon the liver, thereby slowing the progression to potentially life threatening liver~     diseases such as cancer and cirrhosis. This is a preliminary study designed to determine any~     indications under controlled conditions that may warrant further detailed clinical studies.~   "
254069|NCT00225524|"~     Phase III long-term safety study of Effexor XR in patients with major depression.~   "
254070|NCT00225511|"~     Study Evaluating Effexor XR for Major Depression.~   "
254071|NCT00225498|"~     Ziprasidone is a newer drug intended for the treatment of the symptoms of schizophrenia. This~     new drug may have an added benefit of being able to help with some of the difficulties in~     problem solving and memory that many patients with schizophrenia experience. The present~     study wants to look at ziprasidone and two other drugs frequently used to treat the symptoms~     of schizophrenia (risperidone and olanzapine) to see if problem solving and memory get better~     with ziprasidone treatment. Moreover, we will look at symptoms and how they change with~     treatment.~   "
254072|NCT00225485|"~     Phase III study evaluating Effexor XR in elderly patients with major depression.~   "
254073|NCT00225472|"~     Kidney transplantation remains limited by four problems: 1) a too high rate of delayed graft~     function, 2) early loss of kidneys from chronic rejection, 3) donor kidney shortages, and 4)~     the need for immunomodulating treatments. Improved cold storage methods can significantly~     impact on the first 3 of these 4 major problems. The device to be tested is a modification of~     the existing Viaspan organ preservation solution. The modification of this solution combines~     four compounds: Bovine neutrophil peptide-1 (BNP-1), Substance P (SP), Insulin-like growth~     factor-1 (IGF-1), and Nerve Growth Factor (NGF). This solution will be added to Viaspan for~     preservation of donor kidneys. Preclinical data indicates that trophic factor deprivation~     during cold storage is a significant and previously unrecognized mechanism of injury in cold~     stored kidneys. The aim of this study is improved graft function, decreasing early graft loss~     due to rejection, and decreasing the donor organ shortage.~   "
254074|NCT00225459|"~     The purpose of this study is to determine whether or not spiritual and/or religious~     commitment affects mood variability and thoughts of suicide.~      First we hypothesize that among patients with depressive symptoms, those who have higher~     religious/spiritual (R/S) commitment will have less suicidal ideation and less mood~     variability. Second, we hypothesize that higher mood variability will be associated with more~     suicidal ideation. Finally, dependent on the first two hypotheses, we propose that R/S~     commitment will mediate the relationship between mood variability and suicidal ideation.~   "
254075|NCT00225446|"~     The main objective of this study is to validate a simplified platform of a repositioning~     system in orthognathic surgery (a third generation optic repositioning system called~     MicronTracker) compared with the actual clinically validated one (Orthopilot system).~   "
254076|NCT00225433|"~     In vitro fertilization (IVF) is a common procedure used to assist couples who have difficulty~     conceiving a pregnancy. IVF is a process where oocytes (eggs) are retrieved from a woman's~     ovaries and fertilized with sperm in the laboratory. In order to maximize the number of~     oocytes that can be retrieved, a women undergoes ovarian stimulation with recombinant~     follicle stimulating hormone (FSH). Typically 6-20 oocytes are retrieved, but in some cases~     there is a limited response to the stimulation, producing a limited number of oocytes. This~     is called poor ovarian response.~      This study is designed to objectively compare two treatment regimens currently advocated in~     clinical practice, but never compared directly. The purpose is to assess ovarian response to~     starting treatment at the end of the preceding cycle may increase the number of developing~     oocytes.~   "
254077|NCT00225420|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as~     leuprolide, may lessen the amount of androgens made by the body. Radiation therapy uses high~     energy x-rays to kill tumor cells. Giving docetaxel together with androgen ablation therapy~     and external-beam radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when~     given together with androgen ablation therapy and external-beam radiation therapy and to see~     how well they work in treating patients with high-risk localized prostate cancer.~   "
254078|NCT00225407|"~     The purpose of this study is to investigate the processing of cannabis, and to investigate~     the occurrence of effects of cannabis on the cardiovascular system and the central nervous~     system; at higher levels of exposure.~   "
254092|NCT00225225|"~     Given the high prevalence of type 2 diabetes and the 2- to 4-fold increased risk of fatal and~     non-fatal coronary heart disease events in these patients, long-term glycemic control is of~     great importance. TZDs improves glycemic control in patients with type 2 DM as well as~     enhances their insulin-mediated glucose disposal. However, the improvement of glycemic~     control seen with TZDs may be blunted in the long run by weight gain.~      Previous data on weight gain during TZD therapy in patients with type 2 DM is very sparse. It~     is generally assumed that an increase in adipocyte differentiation is the cause of weight~     gain in association with TZD treatment which may limit their use. Increased body weight~     assumed to compromise the positive effects of treatment. There is also a theoretical concern~     that, with the development of new adipocytes, future weight loss may be difficult.~      However, if weight gain is primarily due to failure to adjust caloric intake in proportion to~     the decrease in urinary glucose loss, it is totally preventable. It has been previously shown~     that improvement of glycemia favored weight gain by decreasing the energy loss in the urine~     as glucose. Severity of weight gain appears to be proportional to the level of glycemic~     control achieved.~      The overall goal of the proposed research is to provide the experimental evidence for the~     later alternative by showing that the modest weight gain that takes place in association with~     effective rosiglitazone treatment of hyperglycemic patients with type 2 DM is primarily due~     to its therapeutic efficacy. More specifically, by decreasing the caloric intake in~     proportion to a decrease in urinary glucose loss associated with improved glycemic control,~     we will be able to prevent significant weight gain following Rosiglitazone treatment. In~     order to provide an optimal dietary modification that can be universally applied to~     TZD-treated patients in clinical practice, we will have a group with a fixed amount of~     caloric restriction per day. It will be the first randomized controlled trial of a potential~     strategy for prevention of weight gain associated with thiazolidinediones.~   "
254079|NCT00225394|"~     CMV viral disease negatively affects transplant patients. CMV is the most prevalent infection~     in transplant patients and 3 month drug regimens to prevent the virus have been mostly~     unsuccessful, usually after the drug has been stopped, the patient develops the viral~     disease. Extended use of anti-viral drugs may, in fact, may lead to the development of~     resistant virus. We hypothesize that extended use (12 months) of valganciclovir~     (Valcyte™)will not only be efficacious but will not be associated with the development of~     resistant CMV.~      Sample Size: 100 patients at 3 sites have been enrolled~      Patient Selection: Adult (>18 years) recipients of cadaveric or living donor kidneys,~     pancreas, or combine kidney-pancreas transplants.~      Immunosuppression: To be determined according to each center’s standard protocol (s).~      Study Drug: Valcyte™ Days 0 – 90: All Patients, 900 mg QD~      Days 91 – 365:~      Group 1: 900 mg QD Group 2: 450 mg QD~      Assessment of Valgancicovir (Valcyte™)Resistant CMV : Serial serum samples (at transplant, 6~     weeks, and 3, 6, 9 and 12 months post-transplant) for PCR amplification and DNA sequence~     analysis from detectable CMV to identify the presence of mutations within the UL97 and UL54~     genes.~      Other Analyses:~      Additional information will be evaluated relating to the development of CMV disease,~     development of ganciclovir toxicity, graft rejection or graft loss and patient death.~     Preliminary information regarding the predictive value of DNA assays for the development of~     CMV disease will be evaluated.~   "
254080|NCT00225381|"~     During clinical anesthesia, it is astonishing that CO2 monitoring consists mainly of~     end-tidal PCO2 to confirm endotracheal intubation and to estimate ventilation, and O2~     monitoring consists of a single PO2 measurement to detect a hypoxic gas mixture. Better~     understanding of how O2 and CO2 kinetics monitoring can define systems pathophysiology will~     greatly enhance safety in anesthesia by detecting critical events such as abrupt decrease in~     cardiac output (Q.T) by vena-caval compression during abdominal surgery, occurrence of CO2~     pulmonary embolism during laparoscopy, rising tissue O2 consumption (V.O2) during light~     anesthesia, and onset of anaerobic metabolism (V.CO2 is disproportionately higher than V.O2).~   "
254081|NCT00225368|"~     Insecticide-impregnated bed nets and curtains (ITN) have been shown to be effective against~     malaria. However, given that most ITN studies were of limited length, researchers have~     postulated the hypothesis that in areas of intense malaria transmission and due to possible~     interactions with immunity development, ITN interventions may cause no effect at all or even~     a long-term increase in malaria morbidity and mortality.~      The overall objective of the trial is to analyse the long-term effects of ITN on child~     morbidity and mortality in an area of intense malaria transmission. The specific objective is~     to analyse if there is a difference in the rates of malaria morbidity and mortality as well~     as in all-cause mortality in children being protected with ITNs from birth compared to~     children protected with ITNs from age 6 months onwards.~      The study is conducted in the Nouna Health District, in Burkina Faso, and specifically in a~     sub-portion of the District under demographic surveillance since 1999. The sub-portion of the~     District under demographic surveillance includes a total population of 70 000 individuals,~     distributed in 42 villages and in the town of Nouna. The region is a dry Savannah~     characterised by high levels of malaria transmission.~      The study design entails a prospective community-based trial, with newborn children being~     identified at the village level and then individually randomised to receive either~     intervention A or intervention B. Intervention A is defined as ITN protection from age 0 to~     59 months (i.e. protection from birth). Intervention B is defined as ITN protection from age~     6 to 59 months (i.e. protection from 6 months onwards). Enrollment in the study cohort in~     continued until the sample size is reached (n = 2 600, 1 300 group A and 1 300 group B).~      Detailed data on morbidity is collected through means of a prospective follow up on a~     sub-sample of 420 children from 6 sentinel villages (210 from group A and 210 from group B).~     These 420 children are visited daily by field workers who measure their temperature. In case~     of fever, field workers take a blood sample through finger prick to be analysed for malaria~     parasitaemia. Treatment free of charge is organised for all children in this subsample. In~     addition, these children are visited twice a year for the collection of clinical (malaria~     episodes, anaemia) and parasitological (rates of malaria parasitaemia, parasite density)~     parameters. Data collection on this subsample of children is meant to last from June 2000 to~     December 2003. For study purposes, falciparum malaria is defined as 37.5 C or more plus at~     least 5 000 parasites per micro-litre.~      All-cause mortality in the overall study sample (2 600 children) are ascertained through~     means of a demographic surveillance system (DSS), which regularly monitors deaths (as well as~     births and migration) in the region. The causes of death are identified through means of~     verbal autopsy. All children enrolled in the study are followed up through means of the DSS~     from birth up to 5 years of age.~      The primary study outcome will be the five-year all-cause mortality in the total number of~     children enrolled in the study (2 600). Secondary outcomes will be the study of~     malaria-specific mortality, clinical parameters, and parasitological parameters in a~     sub-sample of the study cohort (420).~   "
254082|NCT00225355|"~     We wish to see if the drug rosiglitazone, currently used in the treatment of type 2 diabetes,~     could be used as a new treatment for angina when compared with placebo in overweight subjects~     who do not have overt diabetes. The drug will be given for 3 months and the subjects will be~     have their angina tested, by way of exercise testing, angina quality of life questionnaire~     and 24-hour ECG monitoring before and after using the drug.~   "
254083|NCT00225342|"~     The principle objective of the trial is to compare rosiglitazone to gliclazide in patients~     with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina~     status changes.~      Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina~     quality of life questionnaire.~   "
254084|NCT00225329|"~     To determine, among healthy first time mothers who are uncertain as to when to come to~     hospital in labour, if home visits by obstetrical nurses compared to telephone advice have an~     impact on reducing cesarean section rate.~   "
254085|NCT00225316|"~     To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency~     and severity of neonatal abstinence syndrome among infants born to substance-using women..~   "
254086|NCT00225303|"~     The purpose of this study is to determinate the effectiveness, safety and tolerability (how~     well the body accepts the drug) of an investigational Non-Nucleoside Reverse Transcriptase~     Inhibitor (NNRTI) called TMC125.~   "
254087|NCT00225290|"~     To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.~   "
254088|NCT00225277|"~     The purpose of this study was to determine the efficacy of pioglitazone, once daily (QD),~     compared to glimepiride on atherosclerotic disease measured by intravascular ultrasound.~   "
254089|NCT00225264|"~     The primary purpose of this study is to compare the effects of pioglitazone, once daily (QD),~     versus glimepiride on the amount of thickening of the carotid artery.~   "
254090|NCT00225251|"~     This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic~     disorder, a form of low-grade chronic depression. We hypothesize that patients taking~     Wellbutrin XL will show greater improvement in depression symptoms and psychosocial~     functioning than patients taking placebo.~   "
254091|NCT00225238|"~     The purpose of this study is to ascertain if the use of Nexium for 7 days prior to taking a~     colon prep for a colonoscopy will decrease the side effects that are associated with the~     colon preparation~   "
254131|NCT00224705|"~     The purpose of this study is to improve the survival rate of those patients with acute~     fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system~     by:~        1. Reducing the number of patients who die before a graft is available~        2. Increasing the chances of survival without a liver transplant~        3. Reducing the pre- and post-operative mortality in transplant patients~   "
254093|NCT00225212|"~     Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas,~     but is limited by relapse occurs in 40 to 50% of subjects.~      This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose~     therapy increases the event-free survival in diffuse aggressive lymphomas and low grade~     lymphomas, as an alternative to the limitations of conventional therapy.~      Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about~     50% with very little toxicity. Rituximab is hypothesized to be a candidate for~     post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen;~     rituximab has impressive independent anti-tumor activity; and the antibody has little~     toxicity outside of the acute administration.~   "
254094|NCT00225199|"~     The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to~     placebo in the treatment of endometriosis~   "
254095|NCT00225186|"~     The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the~     treatment of endometriosis~   "
254096|NCT00225173|"~     Patients with 3 or more adverse prognostic factors have a higher relapse rate. Significant~     anti-tumor activity in Hodgkin's lymphoma has been reported with two new drugs:gemcitabine~     and vinorelbine. The introduction of these new agents with their different mechanisms of~     action into the Stanford V regimen may increase effectiveness while maintaining a favorable~     toxicity profile with respect to fertility and a low risk of secondary leukemia. On this~     basis, we propose a new regimen, Stanford VI, for patients with bulky and advanced HD with 3~     or more risk factors.~   "
254097|NCT00225160|"~     The purpose of this study is to determine whether Acetyl L-carnitine can prevent the~     development of nerve damage, known as neuropathy, in individuals taking anti-HIV drugs over a~     48-week period. In addition the safety and tolerability of Acetyl L-carnitine will be~     assessed.~      This study compares the use of Acetyl L-carnitine or placebo (a dummy drug) in the prevention~     of nerve damage. The current standard of care is to use painkillers to manage the pain, with~     little or no effect. The possible beneficial effects of taking Acetyl L-carnitine is to~     prevent nerve damage as a result of anti-HIV medication.~      The main purposes of the trial are:~        -  to look at the differences in between those on Acetyl L-carnitine versus those on~          placebo~        -  to look at the effect on state of your nervous system in the two treatment groups by~          measuring nerve activity~        -  to learn more about the safety and tolerance of Acetyl L-carnitine~   "
254098|NCT00225147|"~     Hereditary angioedema (HAE) is a genetic disorder characterized by sudden recurrent attacks~     of local swelling (angioedema). These attacks are often painful and disabling, and, in some~     cases, life-threatening. HAE is caused by mutations in the C1INH gene that lead to a~     decrease in the blood level of functional C1INH. This multi-center study was designed to~     assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of~     recombinant human C1 inhibitor (rhC1INH) in the treatment of acute hereditary angioedema~     attacks.~      Funding Source - FDA OOPD~   "
254099|NCT00225121|"~     The primary purpose of this study is to study the side effects of PF-00299804 and determine~     the highest dose that can be safely administered in patients with advanced cancer.~   "
254100|NCT00225108|"~     Venous thromboembolism (VTE) remains the most common cause of maternal death in the developed~     world. VTE includes two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE).~     DVT refers to a blood clot that has formed in a deep vein, often in the legs and/or pelvis~     and PE refers to the passage of these clots into the lungs (which can be fatal). VTE is up to~     10 times more common in pregnant women than non-pregnant women of comparable age. More than a~     third of pregnancy related VTE occur during the 6 weeks after delivery. When compared with~     vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by~     three-fold.~      A medication called low molecular weight heparin is sometimes prescribed during pregnancy and~     after delivery to prevent VTE. However, clinical practice varies because there hasn't been~     adequate research to determine that this medication is safe and effective at preventing VTE~     during this time. The potential benefits of the medication must also be weighed against its~     cost and possible side effects.~      The researchers are conducting a study that will assess the effectiveness and safety of low~     molecular weight heparin in women who are at moderate to high risk of VTE after a cesarean~     section. They will monitor these women to determine if those who received the medication have~     fewer blood clots. Participants will also be monitored closely for any side effects.~   "
254101|NCT00225095|"~     The purpose of this study is to determine whether Chondrogen is a safe and effective~     post-operative treatment of the knee following menisectomy (the surgical removal of all or~     part of a torn meniscus).~   "
254102|NCT00225082|"~     HIV infected subjects receiving antiretroviral treatment for greater than 6 years with be~     evaluated for clinical lipoatrophy and mitochondrial function after switching nucleoside~     analogues from stavudine (d4T) to tenofovir treatment and after 4.~      Hypothesis: Tenofovir therapy will increase peripheral fat content as assessed by DEXA and~     mitochondrial function at 48 weeks.~   "
254103|NCT00225069|"~     To determine outcome and side effects following thoracoscopic sympathectomy in patients~     treated for disabling isolated facial blushing and investigate if there are any significant~     differences between two different routine procedures: T2 or T2-T3 sympathectomy.~   "
254104|NCT00225056|"~     In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly~     docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent~     capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and~     toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on~     days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of~     each cycle will be utilized.~   "
254105|NCT00225043|"~     The study involves research, the purpose of which is to compare three different drug mixtures~     (Epinephrine, Phenylephrine 25 µg, or Phenylephrine 50 µg). Specifically, how long each~     medicine lasts will be studied.~   "
254106|NCT00225030|"~     Observational study of life time prognosis for persons medically treated for arterial~     hypertension, according to current WHO-guidelines.~   "
254107|NCT00225017|"~     The purpose of this study is to evaluate the change in brachial artery reactivity in~     HIV-infected subjects with elevated lipid levels who are switched to an atazanavir containing~     antiretroviral regimen~   "
254108|NCT00225004|"~     The primary purpose of the retrospective study is to determine the incidence of osteoporosis~     in women with previous Colles Fracture. Secondly, to determine to which extent Colles~     Fracture has led to a diagnosis and/or treatment of osteoporosis.~      The primary purpose of the prospective study is to determine the incidence of osteoporosis in~     women with an actual Colles Fracture. Secondly, to investigate the consistency between~     prospective and retrospective data.~   "
254109|NCT00224991|"~     The purpose of this study is to investigate the efficacy of systematic education~     (osteoporosis school) on fall frequency, compliance and quality of life of a group of~     patients more than fifty years of age.~      Hypothetically, systematic information can increase compliance to the medical treatment,~     decrease the frequency of falls and increase the quality of life.~   "
254110|NCT00224978|"~     Chloroquine is a strong lysosomotropic and DNA-intercalating agent in experimental studies~     (Neurosurgical Focus 14(2): February, 2003) and an open-label clinical trial the~     investigators have demonstrated a strong adjuvant effect of chloroquine on the therapy of~     malignant gliomas. This study will assess in a randomized, placebo-controlled, double-blind~     study the effects of chloroquine as adjuvant to the conventional therapy of Glioblastoma~     Multiforme.~   "
254111|NCT00224965|"~     This proposal will conduct a prospective examination of the clinical course (intensity,~     content and duration) of tobacco (nicotine) abstinence effects in male and female smokers who~     are either heavy/light alcohol drinkers with/without depressive symptoms.~   "
254112|NCT00224952|"~     The purpose of the study is to examine the individual metabolic profiles of pediatric~     patients receiving carbamazepine or valproate therapy, in an attempt to determine identities~     of the reactive metabolites or, alternatively, the identities of those metabolites that serve~     as potential precursors to reactive species.~   "
254113|NCT00224939|"~     Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night)~     and renal functional reserve and wether non-dippers (those whose blood pressure does not~     decrease at night) can be modulated to dippers with potassium treatment.~   "
254114|NCT00224926|"~     To explore carrier and infection status of T.tonsurans tinea capitis and characterize the~     host-pathogen interaction as it relates to the disease presentation. The general hypothesis~     for this study is as follows: the type of genotypic and phenotypic variant to which a child~     is exposed accounts for the presentation status observed in Trichophyton tonsurans~     infection.The global outcome of this investigation is to reveal potential new drug targets~     designed to improve treatment outcomes in these children.~   "
254115|NCT00224913|"~     Total knee arthroplasty (TKA) is performed more than 300,000 times a year in the United~     States, most often for osteoarthritis (OA). While pain is predictably reduced, function does~     not typically ever reach that of age-matched, uninjured subjects. Quadriceps weakness has~     been implicated in the development and progression of knee OA and is a significant problem~     after TKA. Voluntary exercise has been ineffective at restoring quadriceps strength after~     TKA. The aims of this study are: 1) to assess the effectiveness of high-level neuromuscular~     electrical stimulation as an adjunct to ongoing intensive, early rehabilitation in restoring~     quadriceps strength and improving the functional outcome after primary TKA, and 2) to~     identify the physiological and morphological bases for improvements in quadriceps strength~     and functional outcome.~   "
254116|NCT00224900|"~     During this phase of the study, a focus group will be conducted with young adolescents~     perinatally infected with HIV and with their caregivers to develop and evaluate the content~     of the proposed intervention. The purpose of the focus groups is to identify key issues and~     challenges that often face young adolescents perinatally infected with HIV and their~     caregivers as well as to elicit suggestions to enhance the feasibility and acceptability of~     the proposed intervention. The focus groups will be audio recorded and transcribed and~     reviewed by all involved in future protocol development. Themes will be pulled directly from~     the focus groups to guide examples and areas of emphasis in the intervention. In addition,~     proposed measures will be administered to the adolescents and their caregivers and assessed~     for appropriateness for this population.~   "
254117|NCT00224887|"~     Primary Hypothesis Children whose mothers receive the FBC sessions will have significantly~     lower BMI one year after the intervention compared to control group children whose families~     receive an active placebo control.~      Secondary Hypotheses In families that receive the FBC, household availability of fruits and~     vegetables will increase, and availability of high fat foods will decrease, as measured by~     multiple household food inventories, compared to control group families exposed to an active~     placebo intervention.~      Household level of food security, mothers' food purchase motives and family food interaction~     will influence the effects of the FBC on household food supplies.~   "
254118|NCT00224874|"~     The study is a randomized Phase II, four arm treatment trial. The primary purpose of the~     study is to define new agents with promising activity against acute graft-versus-host disease~     (GVHD) suitable for testing against corticosteroids alone in a subsequent Phase III trial.~   "
254119|NCT00224861|"~     The specific goals of this project are to (1) refine the Home Automated Telemanagement (HAT)~     program according to the JNC 7 Report based on focus group review conducted by the key~     personnel, primary care providers, and patients and to fully implement the multidisciplinary~     model for hypertension telemanagement in African Americans as an adjunct of ambulatory care~     and (2) evaluate in a randomized clinical trial the impact of HAT on hypertension care~     delivery and on patients' clinical outcomes using both clinic- and patient-level variables.~     The comparison will be made with the standard of hypertension care recommended by the JNC 7~     Report.~      The following primary hypothesis related to clinic-level outcomes will be tested: Use of HAT~     will be associated (1) with improved proportion of treated patients who achieve blood~     pressure goals meeting JNC 7 recommendations, and (2) with a significant reduction in~     systolic and diastolic blood pressure. Researchers will also explore the impact of HAT on~     physician awareness and use of the hypertension treatment guidelines promulgated by the JNC 7~     Report.~      The following secondary exploratory hypothesis related to patient-level outcomes will be~     evaluated: The HAT program will have a positive impact on behavioral and cognitive factors~     that play an important role in the process of patient self-management, including hypertension~     treatment self-efficacy, health locus of control, health beliefs, and hypertension knowledge.~     Researchers will also investigate the impact of HAT on patients' compliance with~     multi-component treatment plans (including adherence to medication regimens and therapeutic~     lifestyle changes) and explore the effect of the HAT system on patients' ability to reach~     dietary, physical activity, weight control, and sodium consumption goals recommended by the~     JNC 7 Report.~      During this study researchers will explore the impact of HAT on patient satisfaction with~     medical care, health-related quality of life, and health services utilization. Researchers~     will also assess acceptance of the HAT system by both patients and providers. Finally,~     researchers will perform a cost-effectiveness analysis of using the HAT system for~     hypertension control.~   "
254132|NCT00224692|"~     Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by~     patient-controlled analgesia with morphine~   "
254120|NCT00224848|"~     This study addresses the challenges associated with implementation of clinical practice~     guidelines (CPG's) and is motivated by our interest in gaining insight regarding the~     following general research questions about CPG implementation:~      A. Can physician adherence to complex CPGs be promoted by use of a hand-held computerized~     decision support tool providing patient-specific recommendations, documentation, and drug~     dosing assistance? B. Will increased adherence to CPGs reduce variation in management by age,~     gender and race/ethnicity such that disparities in healthcare are reduced or eliminated? C.~     What are the cost implications of using PDA-based technology to promote CPG adherence?~      This randomized, controlled, unblinded, practice-based trial will address these research~     questions by testing the following hypotheses in a 2 year behavioral intervention period:~        1. The absolute proportion of patients that is treated appropriately with respect to~          lipid-lowering drug therapy within 4 months after testing will be increased by a net of~          at least 9% by the intervention as measured in baseline and follow-up independent~          cross-sectional samples of eligible patients (primary endpoint).~        2. The absolute proportion of patients that is treated to the appropriate low density~          lipoprotein cholesterol (LDL-C) goal during follow-up of the baseline cohort of eligible~          patients is increased by a net of at least 12% by the intervention (secondary endpoint).~        3. The proportions of eligible patients that are appropriately screened, risk-stratified,~          and counseled regarding therapeutic lifestyle changes are increased by the intervention~          (tertiary endpoints).~        4. The intervention effect in subgroups defined by disease status (CVD, diabetes or~          neither), age, gender, and race/ethnicity reduces any disparities observed at baseline~          (exploratory analyses).~        5. In addition, we will estimate the marginal cost effectiveness of the intervention for~          the primary endpoint.~      The aims were modified in Year 1 to include an attention control group to enable evaluating~     and testing the impact of strategies to improve adherence to the recently released JNC 7~     guideline by testing the following hypotheses:~        1. The absolute proportion of patients that is treated appropriately with respect to blood~          pressure lowering drug therapy will be 10% greater in intervention practices than in~          comparison practices as measured in follow-up independent cross-sectional samples of~          eligible patients (primary endpoint).~        2. The absolute proportion of patients that is treated to the appropriate blood pressure~          goal during follow-up will be 10% greater in the intervention practices (secondary~          endpoint).~        3. The intervention effect in subgroups defined by disease status (CVD, diabetes or~          neither), age, gender, and race/ethnicity reduces any disparities observed at baseline~          (exploratory analyses).~        4. In addition, we will estimate the marginal cost effectiveness of the intervention for~          the primary endpoint.~   "
254121|NCT00224835|"~     The principal objective of the study is to evaluate the effectiveness of a widely used~     complementary medicine intervention, mindfulness-based stress reduction (MBSR), in which~     mindfulness meditation and yoga are the principal components in the treatment of a chronic,~     often fatal illness that affects tens of millions of Americans. The investigators propose to~     conduct a single center randomized controlled trial in which 150 patients will be assigned to~     either a mindfulness meditation condition, a disease education control condition, or a~     stress-monitoring usual care control condition. They will test the following specific~     hypotheses:~        1. In comparison to either of the control conditions, significantly more coronary artery~          disease (CAD) patients in the mindfulness meditation condition will demonstrate~          reductions in mental stress-induced ischemia.~        2. The ratio of low-to-high frequency of spectral power in heart rate variability during~          ambulatory monitoring will be significantly decreased following the participation in a~          stress reduction program compared with those in a disease education or usual care~          condition.~        3. Patients in the mindfulness meditation condition will report greater improvement in~          quality of life (i.e., reductions in general psychological symptomology, anger, anxiety,~          depression, and daily stress, along with increases in optimism and stress coping~          efficacy) than patients in either of the control conditions.~        4. Day-to-day variability in self-reported mental stress will be inversely related to~          day-to-day stress coping efficacy in the entire sample and time spent in mindfulness~          practice in the active treatment condition, and these relationships will be maintained~          over a 3-month follow-up.~        5. Patients with CAD and mental stress ischemia who show an *abnormal peripheral artery~          response during baseline studies will show a significant improvement after mindfulness~          intervention.~             -  Abnormal responses will be defined as peripheral arterial tonometry (PAT) tracings~               that decrease greater than 20% in amplitude during mental stress.~   "
254122|NCT00224822|"~     The primary goal of this study is to assess the effect of aripiprazole on patients who~     developed metabolic syndrome while taking other second generation antipsychotic medications.~   "
254123|NCT00224809|"~     The Transesophageal Echocardiography (TEE) Surgical Treatment of Ischemic Heart Failure~     (STICH) ancillary study will define the mechanism(s) of functional mitral regurgitation (MR)~     by TEE in patients with ischemic cardiomyopathy, and the impact of therapy (medical, coronary~     artery bypass grafting [CABG], or CABG plus surgical ventricular restoration [SVR]) on~     mechanism and severity of MR. Severity of the effect of functional MR on clinical outcomes~     will also be examined. The TEE STICH study will address four specific aims that will focus on~     defining the following: 1) the mechanism(s) of functional MR in ischemic cardiomyopathy; 2)~     the effect of therapy on the mechanism and severity of functional MR; 3) myocardial viability~     on functional MR and its response to treatment; and 4) the effect of MR on prognosis in~     ischemic cardiomyopathy.~   "
254124|NCT00224796|"~     The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure®~     (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot. The~     primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete~     wound closure. Secondary objectives include evaluating the acceleration of wound closure,~     facilitation of surgical closure, incidence of foot salvage, and incidence of wound~     complications.~   "
254125|NCT00224783|"~     The primary objective of the study was to investigate the safety and tolerability of CAIV-T~     liquid formulation in healthy Japanese male adults.~   "
254126|NCT00224770|"~     The purpose of this trial is to determine the safety of using a combination of minimally~     invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES~     arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE~     intention to treat subjects represent the hypothesized test group. The ICES cohort is to be~     analyzed separately.~   "
254127|NCT00224757|"~     In this multi centre pilot study we will perform TEE in patients with AF who are eligible for~     VKA treatment. TTE will be used as pre-screening: if TTE shows left atrial abnormalities or~     aortic plaque, patients will be excluded from randomisation. TEE will be performed in all~     other patients to detect or exclude complex aorta plaques or signs of left atrial stasis.~     Three hundred patients who do not have these features on TTE will be randomly assigned to~     treatment with aspirin or VKA. Follow-up will be 1 year.~   "
254128|NCT00224744|"~     The purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal~     lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of~     Ultracision with regard to classical operative techniques.~   "
254129|NCT00224731|"~     ADHD is often associated with sleep difficulties. Attention-deficit/hyperactivity disorder~     (ADHD) is the most common problem presented to children mental health services. The disorder~     affects approximately 5 % of school-age children. The core symptoms of this disorder include~     varying degrees of inattention, impulsiveness and restlessness.~      In addition to the core symptoms, ADHD is associated with other problems (e.g. academic~     underachievement, poor social relations and sleep disturbances).~      Despite clinical observations of sleep problems in children with ADHD, there is little~     empirical research on this topic. The prevalence, type of sleep problems, and significance of~     these sleep disturbances in children with ADHD remain undocumented.~      The objective is to determine the relationship of sleep problems to attention~     deficit/hyperactive disorder, comorbid disorders, and the effect of stimulant treatment.~   "
254130|NCT00224718|"~     Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to~     propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5~     cm in diameter.~      The aim of the study is to compare the mortality and the occurrence of severe general,~     vascular and local complications in two groups of patients treated by either by open surgery~     or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary~     endpoint are respectively the survival without severe complications and minor morbidity.~   "
254134|NCT00224666|"~     The pains chronic neurogeneses remain difficult to treat whatever are their origin and their~     localization. The pharmacological therapeutic arsenal answers only partially the~     symptomatology often very invalidating which these chronic painful patients present. Electric~     stimulations of the central nervous system currently validated, in particular of the~     posterior cords of marrow made a significant improvement in a certain number of indications.~     Nevertheless, considerable patients are not relieved significantly, in particular those~     presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It~     is within this framework that recently the stimulation of the sensorimotor cortex developed.~      Principal objective: evaluation of the technique of stimulation under cortical on neuropathic~     pains .~   "
254135|NCT00224653|"~     To assess the potential benefits on mechanical ventilation plateau pressure of pressure~     controlled mode versus volume controlled mode for laparoscopic bariatric surgery in obese~     patients (BMI > 35). High plateau pressures encountered in obese patients due to their~     reduced pulmonary compliance could be lowered using pressure controlled mechanical~     ventilation.~   "
254136|NCT00224640|"~     Friedreich ataxia, an autosomal recessive condition, ascribed to frataxin gene expansion, has~     been shown to result from an iron- induced injury to the mitochondrial respiratory chain.~     Buffering free radicals with short-chain quinones (Idebenone) protects the patients against~     cardiomyopathy but not CNS involvement. Removing CNS iron should limit the impact of the~     neurological symptoms of the disease.~   "
254137|NCT00224627|"~     Capsule endoscopy (CE) is a safe and effective tool for the assessment of obscure~     gastrointestinal bleeding (OGIB). However, its real efficacy and its position in the~     diagnostic algorithm of OGIB vs. push enteroscopy (PE) remain unknown since in previous~     studies both techniques were performed in all included patients The purpose of this protocol~     is to conduct a randomized prospective controlled trial in patients with OGIB comparing a~     strategy based on CE or PE followed by the alternative exploration only when the first line~     exploration was negative. The main outpoint of this study concerns the diagnostic yield of~     the two explorations. Second endpoint concerns the clinical relevance of the two strategies~     tested (CE ± PE vs. CE ± PE) in terms of diagnostic yield, clinical outcome, therapeutic~     impact and added explorations~   "
254138|NCT00224614|"~     The allograft of marrow in its technique of reference (myélo-ablative (MA) condition by~     cyclophosphamide and total body irradiation (TBI) with strong amounts) therapeutic is~     recognized acute myeloid leukaemia (AML) of the adult for the patients of less than 55 years,~     because it offers chances of cure higher than chemotherapy or the auto-graft. However,~     mortality related to the traditional graft is approximately 30% to 1 year. The recent use of~     the non-myélo-ablative graft (NMA), in which the anti-leukaemia effect rests exclusively on~     the allogenic effect graft-versus-leukaemia makes it possible to obtain among patients of~     more than 55 years in complete reemission (CR), survivals without relapses comparable with~     the traditional allograft among patients of more than 35 years. The major interest of NMA~     graft is to reduce early mortality related to the graft. This reduction should be all the~     more significant as the patient is younger, and thus bring to a better survival. There is~     not, at the present hour, of prospective comparative study of the two procedures of graft.~     Taking into account the results observed after NMA graft among patients of more than 55~     years, and taking into account the toxicity of the standard graft between 35 and 55 years, it~     is essential to now compare the 2 approaches among patients who do not have a~     counter-indication for one or the other, in the age bracket where the toxicity of the~     traditional graft is highest.~   "
254139|NCT00224601|"~     The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to~     increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with~     HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.~   "
254140|NCT00224588|"~     We assessed the effects of the N Methyl aspartate receptor antagonist Ketamine on long-term~     post thoracotomy pain. We hypothesized that ketamine could prevent supersensitization of the~     central nervous system involved in this chronic neuropathic pain.~   "
254141|NCT00224575|"~     Despite the effectiveness of beta-blockers and antiplatelet agents for secondary prevention~     of coronary heart disease, this treatments are underused in the elderly because of diagnosis~     uncertainty and underuse of efficient treatment.~      in a first time, diagnosis reassessment with invasive technique if necessary. in a second~     time, treatment reassessment.~   "
254142|NCT00224562|"~     The RATIO registry is a French registry designed by a multidisciplinary group to collect data~     on opportunistic and severe bacterial infections and lymphoma in patients treated with TNF-a~     antagonists ( infliximab, etanercept and adalimumab). A total of 486 medical units in~     metropolitan France participate in the RATIO registry. All diagnosis are retained after~     validation by 2 qualified infectious disease or haematologist physicians (on the basis of the~     standardized case report form, the hospitalisation summary, and the microbiological and~     radiological results). Risk factors for developing these conditions when treated by TNF-a~     antagonists will be identified in a case control study. Incidence of these diseases will be~     calculated.~   "
254143|NCT00224549|"~     The purpose of this study is to assess the efficacy of two different treatment regimens for~     treating resistant hypertension previously uncontrolled with at least 3 antihypertensive~     treatments. The study hypothesis is that these two regimens (one based on increasing~     diuretics and the other based on increasing renin angiotensin system blockage) may not differ~     in terms of efficacy.~   "
254192|NCT00223925|"~     Cytomegalovirus (CMV) infections remain a significant problem following various types of~     transplants that are associated with strong immunosuppressive therapy. Maribavir is a new~     oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV~     drugs. This study will test the safety and anti-CMV activity of different doses of maribavir~     when given as CMV prophylaxis following stem cell transplants.~   "
254193|NCT00223912|"~     The purpose of this study is to determine if exercise affects the clotting of blood~     (hemostasis). The effect of exercise on hemostasis will be determined in persons with spinal~     cord injury, a population reported to have an increased prevalence of cardiovascular disease~     (CVD). It is expected that this study will increase our understanding of CVD in persons with~     SCI, and it will eventually help reduce the occurrence of premature heart disease.~   "
254144|NCT00224536|"~     After successful percutaneous coronary intervention (PCI) for acute ST-segment elevation~     myocardial infarction, 60 patients were randomly assigned to either a control group (n=30)~     that received optimum postinfarction medical treatment, or a bone-marrow-cell group (n=30)~     that received optimum medical treatment and intracoronary transfer of autologous bone-marrow~     cells 4·8 days (SD 1·3) after PCI. Primary endpoint was global left-ventricular ejection~     fraction (LVEF) change from baseline to 6 months’ follow-up, as determined by cardiac MRI.~     Image analyses were done by two investigators blinded for treatment assignment. Analysis was~     per protocol.~      Global LVEF at baseline (determined 3·5 days [SD 1·5] after PCI) was 51·3 (9·3%) in controls~     and 50·0 (10·0%) in the bone-marrow cell group (p=0·59). After 6 months, mean global LVEF had~     increased by 0·7 percentage points in the control group and 6·7 percentage points in the~     bone-marrow-cell group (P=0·0026).~      Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in~     myocardial segments adjacent to the infarcted area. Cell transfer did not increase the risk~     of adverse clinical events, in-stent restenosis, or proarrhythmic effects.~   "
254145|NCT00224523|"~     Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active~     control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with~     perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper~     airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by~     house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal~     congestion, rhinorrhea and/or nasal itching.~   "
254146|NCT00224510|"~     This is a study that, in the first 16 weeks, investigates whether lamotrigine versus placebo~     offers effect on depressive episodes for patients with bipolar disorder (also known as manic~     depressive disorder) who use lithium. In the following 50 weeks it is investigated whether~     these patients experience effect on their depressive and/ or (hypo)manic episodes.~   "
254147|NCT00224497|"~     The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it~     has on the symptoms of mild to moderate Alzheimer's disease. SB-742457 is a new treatment~     which is thought to increase the levels of certain chemicals in the brain that are often~     decreased in patients with Alzheimer's disease.~   "
254148|NCT00224484|"~     Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between~     the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study~     period (up to month 12).~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
254149|NCT00224471|"~     Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different~     commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged~     10-17 years, determined by ELISA. Absence in significant variation for both parameters among~     the tested lots was hypothesized.~   "
254150|NCT00224458|"~     To characterize the risks (safety and tolerability), effectiveness (continued viral load~     suppression and CD4 changes), and benefits (safety, tolerability, adherence, general~     satisfaction with the treatment regimen and QoL), of switching from a Combivir (BID) /~     efavirenz (QD) regimen to an all QD regimen of Truvada/efavirenz.~   "
254151|NCT00224445|"~     To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen~     consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir~     boosted with ritonavir in treatment naive patients.~   "
254152|NCT00224432|"~     To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on~     clinical and immunological parameters in infants with AD with and without CMA and to compare~     effectiveness of different strains of probiotics.~   "
254153|NCT00224419|"~     Nicotine dependence has not been sufficiently addressed in current state-of-the-science~     cessation interventions for pregnant smokers. The weight of the evidence from the general~     population of smokers suggests that nicotine replacement therapies may be beneficial~     cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential~     of these therapies for promoting smoking cessation among pregnant women creates a pressing~     need for decision tools and protocols to encourage treatment adherence that is essential for~     rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care.~     The results of this research could be directly translated to the improvement of obstetrical~     care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers~     is an alternative to continued smoking that has the potential to substantially increase rates~     of smoking cessation during pregnancy.~   "
254154|NCT00224406|"~     The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear~     neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Repertaxin~     is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and~     efficacy of repertaxin in preventing the primary graft dysfunction (PGD) after lung~     transplantation.~   "
254155|NCT00224393|"~     The purpose of this study is to evaluate the efficacy of Enbrel in patients with primary~     systemic Amyloidosis.~   "
254156|NCT00224380|"~     The goal of this pilot study is to learn about how well older people with serious mental~     illness (including schizophrenia, schizoaffective disorder, bipolar disorder, major~     depression) follow prescribed medication regimens, and to evaluate a manualized intervention~     designed to enhance medication management skills and adherence, the Using Medications~     Effectively program. The following four hypotheses will be tested:~        1. Medication adherence will be associated with several variables including insight,~          memory, medication management skill, knowledge about medications, attitudes about~          medications.~        2. People who receive the program will have better medication adherence compared to those~          who do not receive the program as measured by pill counts.~        3. People who receive the program will develop better medication management skills compared~          to those who do not receive the program.~   "
254194|NCT00223899|"~     To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5~     mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per~     tumor) followed by electroporation.~   "
254195|NCT00223873|"~     The purpose of this study is to determine the effect of penile vibratory stimulation on the~     muscle spasticity of men with chronic spinal cord injury.~   "
254157|NCT00224367|"~     Hip fractures are a significant problem for healthcare providers due to the increasing~     incidence of fractures in an ageing population. Hip fracture is the most frequent fracture~     for people over 80 years of age and the second most frequent for those over 65 years. It is~     projected that by 2051, 23% of the Australian population will be older than 65 and the number~     of hip fractures will rise fourfold (17,000 in 2004, to 60,000 in 2051).~      Evidence-based clinical practice guidelines regarding management of hip fracture were~     published in the Medical Journal of Australia in 1999 and updated in 2003. Seventeen aspects~     of treatment were systematically reviewed, including mobilisation after surgery. Early~     assisted ambulation within 48 hours post surgery was recommended (Chilov 2003 p 490).~     However, the recommendation was based on observational (level 3) evidence only.~      Early mobilization post surgery is resource intensive. Early mobilization is challenging and~     uncomfortable for the patient and requires the assistance of one or sometimes two,~     physiotherapists available seven days per week. Benefits must be rigorously evaluated to~     justify recommendation. We undertook a randomized controlled trial of the effect of two~     different ‘time to first ambulation’ intervals after hip fracture surgery on patient and~     hospital outcomes.Our hypothesis was that early mobilisation would accelerate functional~     recovery after hip fracture surgery.~   "
254158|NCT00224354|"~     In the laboratory, we will put a special gene into cancer cells that have been taken from the~     subject. This gene will make the cells produce interleukin 2 (IL-2), which may help the~     patient's immune system kill cancer cells. Also, we will use CD40 ligand (CD40L) with the~     IL-2. Studies of cancers in animals and in cancer cells that are grown in laboratories have~     suggested adding the CD40L helps the IL-2 work better. Some of these new cells will then be~     given back to the subject as a vaccine shot.~      We believe that a part of the subject's immune system (cells called T-reg cells) might try to~     kill off these special cells. If the T-reg cells do that, the vaccine would not work as well~     or last as long. To try to avoid this, before the special cells are put back into the~     subject's body, we will give them an intravenous (IV) dose of IL-2 immunotoxin (called~     denileuk diftitox or ONTAK). ONTAK should get rid of some of the T-reg cells in the subject's~     body which should help the special cells work better and longer.~      The purpose of this study is to learn the safety and cancer-fighting effects of using IL-2~     with the vaccine.~   "
254159|NCT00280839|"~     The purpose of this research study is to determine if topiramate is safe and effective in the~     treatment of smoking cessation~   "
254160|NCT00224341|"~     The objective of this trial is to show the therapeutic efficacy of the preventive pacing~     therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial~     fibrillation (AF). Two new algorithms (post-AF response and ventricular rate stabilization~     [VRS]) will be assessed in a combined pathway, compared to a control group. The efficacy of~     the overall available therapies to prevent AF and its symptoms will then be assessed also.~   "
254161|NCT00224328|"~     Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues~     up to 2cm below the skin. It has been investigated, with success, in cerebral,~     gastrointestinal, and muscle tissue, and shows promise in numerous indications involving~     tissue ischemia. In the current study, we propose to examine one hundred patients requiring~     either bypass or angioplasty due to chronic critical limb ischemia resulting from peripheral~     arterial disease. We intend to challenge patients before and after the intervention, using~     either an inflated blood pressure cuff or toe raises, to determine if oxygen saturation~     recovery time in the affected limb is correlated with symptom resolution (i.e. treatment~     success). Near-infrared spectroscopy will be performed using the ODISsey tissue oximeter~     developed by ViOptix, Inc. The proposed study will take approximately one year to complete~     enrolment, and has a follow-up period of 6 months post-intervention.~      Study Hypothesis: Knowledge of tissue oxygen saturation enhances clinical decision making in~     patients with chronic critical limb ischemia.~   "
254162|NCT00224315|"~     We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a~     randomized, prospective manner.~   "
254163|NCT00224302|"~     We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive~     episodes during the course of psychotic disorders~   "
254164|NCT00224289|"~     Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it~     is plausible that the age of a patient using the medication may affect its efficacy and time~     of onset.~      We are going to study the effectiveness of Latanoprost in people of different ages, to see if~     it changes based on the age of the patient.~   "
254165|NCT00224276|"~     This pilot study hypothesizes that diagnosed and undiagnosed prevalence of diabetes mellitus~     may differ across antipsychotioc medications in a community mental health center. The study~     further hypothesizes that control of diabetes among diagnosed cases may be suboptimal.~   "
254166|NCT00224263|"~     The purpose of this study is to determine whether Lingzhi (Ganoderma), a widely used~     traditional Chinese Medicine is effective and safe in the treatment of Parkinson's disease~     when combined use with L-dopa.~   "
254167|NCT00224250|"~     Our hypothesis is that there is no difference in the healing process in those women who have~     a one- or two-layer uterine closure at the time of cesarean delivery.~   "
254168|NCT00224237|"~     This study will explore how culture influences the use of folk healing practices and medical~     services in Latinos with chronic medical conditions.~   "
254169|NCT00224224|"~     The goal of this study is to identify objective differences between primary care and~     traditional medicine residents in clinical performance, continuity of care and utilization of~     resources. Specifically, this retrospective study will analyze the database collected by~     CLIMACS, the computer system at Cornell Internal Medicine Associates (CIMA). This system is~     used for clinical and administrative purposes; it manages and tracks patient's information~     and demographics, appointment booking, clinical diagnosis, prescriptions and medications,~     laboratory and radiology test, and consults. In our study, we will analyze a subset of the~     CLIMACS database from previous years.~   "
254222|NCT00223522|"~     The purpose of this study is to prospectively examine adherence to oral atypical~     antipsychotics in patients with schizophrenia. We are psrticularly interested in examining~     the level of agreement among self-report, physician impressions and objective measures of~     adherence. We believe that physicians, casemanagers, and clients significantly overestimate~     the level of adherence.~   "
254170|NCT00224211|"~     This project is being done in order to determine if the music of Mozart will have a soothing~     effect on premature infants while in the neonatal intensive care unit (NICU). The primary~     effect to be anticipated will be a reduction in heart rate from baseline, decreased motor~     activity from baseline, as well as an increase of time in which the babies are in quiet sleep~     states while the music is being played.~      Upon admission, all infants in the NICU are placed on monitors that continuously track their~     heart rate, respiratory rate, and oxygen saturation. During our study, data will be collected~     from the monitors already in use. Total time of observation will be approximately 3 hours. In~     addition, a monitoring device called an Actiwatch will also be used. This device looks~     similar to a traditional wristwatch and will be loosely strapped to the ankle or wrist of~     each infant using a foam and velcro strap. This device continuously monitors the baby's~     movements allowing us to determine if there is a change in the baby's activity level while~     the music is being played. It will record the baby's activity prior to the start of the music~     and will continue until 30 minutes after the music has stopped.~      The music of Mozart will be played using a small speaker in the baby's isolette. The volume~     of the music will be set at 10 decibels over background noise, which on previous measurement~     has been found to be approximately 55 decibels (about the same as a running refrigerator or~     as the sound of rainfall; 60 decibels is the volume of normal conversation). The volume in~     the crib will be continuously monitored throughout the hour. As a final recording device, we~     will also intermittently be using video to capture the reactions of these infants to the~     music. The study will be done once a week per infant on the same day and at the same time~     every week~   "
254171|NCT00224198|"~     The purpose of this protocol is to obtain biologic materials from the blood and lungs from~     patients with lung disease in order to develop an understanding of the etiology and~     pathogenesis of these disorders. General admission criteria for this project will require at~     least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-ray~     consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4)~     lung biopsy consistent with lung disease; (5) family history of lung disease; and (6)~     patients with diseases of organs with known association with lung disease.~   "
254172|NCT00224185|"~     The purpose of this study is to obtain biologic materials from the blood and lungs of normal~     individuals to establish a set of normal range for various parameters. These will provide~     important information when applied to individuals with various pulmonary diseases, and will~     help in understanding of the etiology and pathogenesis of various lung diseases.~   "
254173|NCT00224172|"~     The aim of this study is to construct a prognostic model to identify risks of poor outcomes~     at one year following hospital discharge of patients treated in an ambulatory cate setting.~     The study will incorporate pre-hospitalization characteristics, hospitalization events,~     comorbidity burden, psychosocial measures and post-hospitalization care characteristics to~     predict re-hospitalization and mortality at one year.~   "
254174|NCT00224159|"~     The purpose of this research is to improve our understanding of the effects that taking~     cholesterol reducing pills have on dietary behavior as well as other health related behaviors~   "
254175|NCT00224146|"~     This study evaluates changes in health related quality of life outcomes in patients using~     Oxytrol(r)~   "
254176|NCT00224133|"~     A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term~     safety.~   "
254177|NCT00224120|"~     A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is~     safe and effective. The study lasts approximately 20 weeks.~   "
254178|NCT00224107|"~     A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is~     safe and effective. The study lasts approximately 20 weeks.~   "
254179|NCT00224094|"~     This study compares the effects of 12 weeks of treatment with transdermal versus oral~     estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal~     women.~   "
254180|NCT00224081|"~     This study explores the safety and efficacy of intravenous iron therapy in anemic~     hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but~     low to normal transferrin saturation.~   "
254181|NCT00224068|"~     This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of~     intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to~     epoetin alfa among anemic cancer patients receiving chemotherapy.~   "
254182|NCT00224055|"~     This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate~     (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease~     patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow~     to make more red blood cells).~   "
254183|NCT00224042|"~     This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate~     (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease~     patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.~   "
254184|NCT00224029|"~     This study will evaluate the efficacy and safety of an anticholinergic drug treatment~     administered by transdermal patch to treat overactive bladder in adults who have spinal cord~     injury.~   "
254185|NCT00224016|"~     This study will evaluate the safety and effectiveness of an anticholinergic drug treatment~     administered by transdermal patch to treat overactive bladder in children who have a~     neurological condition (e.g. spina bifida) that contributes to their overactive bladder.~   "
254186|NCT00224003|"~     A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal~     guardian had provided signed informed consent, and who had satisfied the inclusion and~     exclusion criteria of the study.~   "
254187|NCT00223990|"~     This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate~     malaria vaccine is being developed for the routine immunization of infants and children~     living in malaria-endemic areas. This vaccine would offer protection against malaria disease~     due to the parasite Plasmodium falciparum.~      Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve~     adults and 40 adults and 90 children living in malaria-endemic regions.~      This study will investigate whether the candidate vaccine prevents malaria disease for 6~     months post-vaccination.~      One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine.~   "
254188|NCT00223977|"~     This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and~     provide signed informed consent will be randomized to receive one of two levels of Ferrlecit~     or oral iron in a 1:1:1 ratio.~   "
254189|NCT00223964|"~     This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal~     guardian had provided signed informed consent and satisfied the inclusion and exclusion~     criteria.~   "
254190|NCT00223951|"~     The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in~     healthy normal volunteers~   "
254196|NCT00223860|"~     There is evidence that has shown that serum testosterone levels are low in persons with~     chronic spinal cord injury (SCI). The question arises as to whether the defect in~     testosterone production is from the hypothalamic pituitary system (part of the brain that~     plays a role in testosterone release) or from the male testes. Studies to date are~     inconclusive. This study, will examine if persons with SCI has a normal hormonal regulation~     of the male hormone testosterone in comparison to persons who are able-bodied. This will help~     understand the physical and metabolic changes that occur in persons with SCI.~   "
254197|NCT00223847|"~     The purpose of this study is to investigate the effects of intensive, constraint induced~     language therapy (CILT) for individuals with chronic aphasia compared with traditional~     aphasia therapy. The specific objectives of the proposed research are to determine the~     effects of therapy type (CILT vs. traditional) and dose density (intensive or distributed) on~     speech therapy outcome. In addition, we will investigate the functional and qualitative~     impact of these interventions on functional communication.~   "
254198|NCT00223834|"~     This study will examine the barriers and supports for entering and receiving work-related~     services for veterans with a serious mental illness. It will also determine the effectiveness~     of a brief motivational interviewing intervention designed to help veterans receive these~     services.~   "
254199|NCT00223821|"~     The primary objective of this project is to evaluate whether enhancing drug therapy with~     components of behavioral training, including pelvic floor muscle rehabilitation, results in~     better outcomes than drug therapy alone for urge incontinence in community-dwelling women.~   "
254200|NCT00223808|"~     The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose~     therapy program for persons recovering from a recent stroke using mechanically-assisted upper~     limb movement with a device called MIME. A control group receives additional occupational~     therapy without the use of MIME.~   "
254201|NCT00223795|"~     The purpose of this study is to assess whether the single point cane will relieve pain and~     disability in overweight or obese people with knee OA through altered joint biomechanics and~     what factors influence acceptance of cane use.~   "
254202|NCT00223782|"~     The purpose of this study is to determine whether individuals with diabetic peripheral~     neuropathy can learn to change the way they walk in order to reduce the pressures underneath~     the feet, which may lead to a reduced risk of foot ulceration.~   "
254203|NCT00223769|"~     The purpose of this study is to determine the effect of oxandrolone on the function and~     quality of life of patients with chronic spinal cord injury.~   "
254204|NCT00223756|"~     The primary purpose of this research study is to evaluate the effectiveness of a new~     outpatient low vision rehabilitation program that is targeted to serve legally blind veterans~     with central vision loss. The hypothesis is that veterans in the treatment group will~     self-report less difficulty performing daily activities than veterans in the control group~     who are on a waiting list for VA low vision or blind rehabilitation programs.~   "
254205|NCT00223743|"~     The purpose of this pilot study is to obtain information whether the medication zonisamide~     reduces tremor in persons with essential tremor and is well tolerated.~   "
254206|NCT00223730|"~     Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell~     transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by~     damage to the liver and to cells lining blood vessels.~      We, the researchers at Vanderbilt University, propose to perform a randomized, prospective,~     double-blind, placebo-controlled study of 144 patients undergoing allogeneic marrow~     transplantation. The treatment is aimed at supporting hepatic urea cycle function in patients~     receiving escalated dose chemotherapy/BMT. By so doing we hope to prevent development of~     hepatic venoocclusive disease (HVOD) and acute lung injury (ALI), two morbid complications of~     BMT. Patients will be randomized to receive oral citrulline, a urea cycle amino acid~     intermediate, or placebo beginning before conditioning therapy and continuing until 21 days~     after BMT. All patients will be followed for 100 days after study enrollment with intensive~     data collection.~   "
254207|NCT00223717|"~     Supine hypertension is a common problem that affects at least 50% of patients with primary~     autonomic failure. Supine hypertension can be severe, and complicates the treatment of~     orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg,~     fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also~     cause target organ damage in this group of patients. The pathophysiologic mechanisms causing~     supine hypertension in patients with autonomic failure have not been defined.~      In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29~     with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients~     had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood~     pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in~     21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and~     plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with~     AF and supine hypertension. (Shannon et al., 1997).~      Our group has showed that a residual sympathetic function contributes to supine hypertension~     in patients with severe autonomic failure and that this effect is more prominent in patients~     with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor~     response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF~     patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12~     +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine~     hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor~     blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate~     did not change in either group. This result suggests that residual sympathetic activity~     drives supine hypertension in MSA; in contrast, supine hypertension in PAF.~      It is hoped that from this study will emerge a complete picture of the supine hypertension of~     autonomic failure. Understanding the mechanism of this paradoxical hypertension in the~     setting of profound loss of sympathetic function will improve our approach to the treatment~     of hypertension in autonomic failure, and it could also contribute to our understanding of~     hypertension in general.~   "
254216|NCT00223600|"~     1062 children at the age of 7 months and their families were randomized 1:1 in an~     intervention arm and a control arm. The intervention families has received child-oriented and~     individualized nutritional and life-style counseling that aims at decreasing child's exposure~     to the known environmental atherosclerosis risk factors. The controls children receive~     information as given at the well-baby clinics and in school health care of children and~     adolescents. The hypothesis is that the intervention children have healthier food habits and~     serum serum lipid and lipoprotein concentrations than the controls, fewer of them start~     smoking, and their physical activity level is higher than that of the controls.~   "
254217|NCT00223587|"~     On-the-road driving performance of untreated seasonal allergic rhinitis patients during the~     allergic season (exposed) is compared to driving performance outside the allergic season (in~     winter, not-exposed).~   "
254236|NCT00223327|"~     This protocol is for a clinical trial to evaluate the reliability of the bite fork as a~     diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.~   "
254208|NCT00223704|"~     Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary~     bypass (CPB). CPB is associated with significant morbidity including the transfusion of~     allogenic blood products, inflammation and hemodynamic instability. In fact, approximately~     20% of all blood products transfused are associated with coronary artery bypass grafting~     procedures. Transfusion of allogenic blood products is associated with well-documented~     morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to~     increased blood product transfusion in the perioperative period. The current proposal tests~     the central hypothesis that endogenous bradykinin contributes to the hemodynamic,~     fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will~     reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test~     the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE~     inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the~     hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic,~     and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that~     bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in~     patients undergoing CPB. These studies promise to provide important information regarding the~     effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in~     patients undergoing CPB.~   "
254209|NCT00223691|"~     The autonomic nervous system serves multiple regulatory functions in the body, including the~     regulation of blood pressure and heart rate, gut motility, sweating and sexual function.~     There are several diseases characterized by abnormal function of the autonomic nervous~     system. Medications can also alter autonomic function. Impairment of the autonomic nervous~     system by diseases or drugs may lead to several symptoms, including blood pressure problems~     (e.g., high blood pressure lying down and low blood pressure on standing), sweating~     abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for~     these patients are limited. We propose to study patients autonomic failure and low blood~     pressure upon standing and determine the cause of their disease by history and examination~     and their response to autonomic testing which have already been standardized in our~     laboratory. Based on their possible cause, we will tests different medications that may~     alleviate their symptoms.~   "
254210|NCT00223678|"~     A study to determine the effect on renal function in renal transplant patients with biopsy~     proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin~     inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on~     their CI protocol~   "
254211|NCT00223665|"~     This study was a prospective analysis in men with localized prostate cancer who had rising~     Prostate Specific Antigen (PSA) levels after definitive treatment with surgery or radiation.~     Patients received Intermittent Androgen Suppression (IAS) in 9 month cycles until they became~     metastatic, became castrate resistant, or withdrew from the study. Subjects were monitored~     for time to development of Castration Resistant Prostate Cancer (CRPC) and overall survival.~     They were also monitored for the impact of IAS on a variety of neuro-psychiatric assessments~     and on bone density.~   "
254212|NCT00223652|"~     The purpose of this study is to examine the efficacy of telephone-administered~     cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by~     community-based outpatient clinics (CBOCs) in the Veteran's Integrated Service Network (VISN)~     21, which serves rural areas in Northern California and (VISN) 12, which serves rural areas~     surrounding the Hines, IL VA Hospital.~   "
254213|NCT00223639|"~     In the last decade, there has been an explosion of new knowledge of the neuroscientific basis~     of alcohol-seeking behavior. Briefly, medications that modulate mesolimbic dopamine pathways~     by facilitating gamma amino butyric function and inhibiting the action of excitatory amino~     acids should reliably diminish alcohol's rewarding effects. Topiramate (a~     sulfamate-substituted fructo-pyranose derivative) has these characteristics. In support of~     this concept, we have shown in a phase-II-type medications clinical trial that topiramate is~     significantly superior to placebo at improving drinking outcomes and decreasing craving among~     (N = 150) alcohol-dependent individuals. Using the carefully controlled environment of the~     human laboratory, we are submitting a revised application containing a set of systematic~     studies to assess directly the mechanistic neuropharmacological processes that are associated~     with topiramate's anti-drinking effects. This will provide a more comprehensive understanding~     of the neurobiology of alcohol-seeking behavior and aid in the development of even more~     effective compounds for the treatment of alcohol dependence. Thus, the specific aims of the~     project are to: 1) determine the dose-relationship of acute effects of topiramate to reduce~     alcohol effects related to its abuse and addiction potential. We hypothesize that topiramate~     will reduce alcohol-induced craving, reward, and euphoria; 2) determine whether chronic~     treatment with an acutely effective dose of topiramate produces substantial reductions in~     alcohol-related cue-induced craving, thereby decreasing the potential for treatment relapse.~     We hypothesize that chronic topiramate administration will desensitize (reduce) alcohol~     craving produced by alcohol-related sensory cues; and 3) determine whether topiramate~     interactions with and without alcohol are associated with neurocognitive impairment. Clinical~     studies including ours have suggested that topiramate use may be associated with~     neurocognitive effects such as loss of concentration and memory impairment. In our own study,~     these effects were mild and not associated with reduced treatment compliance. Since alcohol's~     ability to produce neurocognitive impairment may be mediated through similar ionic mechanisms~     to that of topiramate, the proposed human laboratory setting affords us the unique~     opportunity to more clearly delineate topiramate's neurocognitive effects in both the~     presence and absence of alcohol. This study supports NIAAA's goal to develop effective~     medications for treating alcoholism and to understand the basic underpinnings of the disease.~   "
254214|NCT00223626|"~     Cocaine addiction is a serious health problem with no available medical treatment for~     preventing relapse. Topiramate, a medication which lowers dopamine levels, may have the~     ability to diminish cocaine cravings in addicts. The purpose of this study is to determine~     the effectiveness of topiramate in reducing cocaine's rewarding effects in individuals~     addicted to cocaine.~   "
254215|NCT00223613|"~     Children born in Turku, Oulu and Tampere university cities in Finland are screened at birth~     for HLA alleles that carry increased risk to or protection from development of type 1~     diabetes. Children carrying increased risk are followed at 3-12-month intervals for~     development of diabetes-associated autoantibodies. Children having at least two types of~     autoantibodies (of the four measured) in at least two consecutively drawn samples are~     randomized to receive daily intranasal insulin or placebo in a double-blinded 1:1 trial.~     Hypothesis is that intranasal insulin delays or prevents development of clinical type 1~     diabetes. The primary outcome measure is development of clinical diabetes.~   "
254218|NCT00223574|"~     A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate,~     low glycemic index diet, results in more rapid progression of diabetes; i.e. increased~     fasting glucose and glycated hemoglobin, reduced beta-cell function and insulin sensitivity~     and increased free fatty acids. The deleterious effects of a high carbohydrate diet on plasma~     lipids are only temporary and do not persist beyond 6 months. A long-term high carbohydrate,~     low glycemic index diet, compared to a high carbohydrate, high glycemic index diet, improves~     glycemic control and beta-cell function~   "
254223|NCT00223509|"~     -  To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the~          acute treatment of patients in a mixed state of bipolar disorder.~        -  To evaluate the efficacy and of a combination of LAM+existing regimen of mood~          stabilizers in the maintenance treatment of patients with mixed state of bipolar~          disorder~   "
254224|NCT00223496|"~     1. Determine the change in symptomatology and function in refractory bipolar depression,~          when treated with combination of DEP+AZP for a period of 12 weeks~        2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory~          bipolar depression~   "
254225|NCT00223483|"~     This research study goal is to analyze the plasma and the cells that make up part of the~     immune system. We want to learn how the plasma and cells work. These may influence why one~     person will develop an infection and another will not, or why one person develops severe~     symptoms of a disease while others remain without symptoms.~   "
254226|NCT00223470|"~     This clinical trial evaluates the role of cytokines in patients needing root canal treatment~     with diagnosis of necrotic pulp and chronic apical periodontitis~   "
254227|NCT00223457|"~     The purpose of this study is to evaluate the coorelation between patient factors, health care~     provider factors, drug factors and compliance in patients with relapsing forms of multiple~     sclerosis (RMS) treated with Disease Modifying Agents (DMA). We hypothesize that a number of~     factors influence compliance with DMA's.~   "
254228|NCT00223444|"~     The purpose of the study is to better understand how genetic factors influence individual~     sensitivity to alcohol.~   "
254229|NCT00223431|"~     Objectives: The purpose of this research was to determine the clinical success rate of a~     lithia-disilicate-based core ceramic (Ivoclar, Vivadent Corp.) for use in posterior fixed~     partial dentures (FPDs) as a function of bite force, cement type, connector height, and~     connector width.~      Methods: Thirty ceramic FPD core frameworks were prepared using a hot-pressing technique and~     a lithia-disilicate-based core ceramic. The maximum clenching force was measured for each~     patient prior to tooth preparation. Connector heights and widths were measured for each FPD.~     Patients were recalled yearly after cementation for two years and evaluated using eleven~     clinical criteria. All FPDs were examined by two independent clinicians and rankings for each~     criterion were made from 1 to 4 with 4 = excellent and 1 = unacceptable.~      The aims of this research were:~        1. To test the hypotheses that three-unit fixed partial dentures (FPDs) of a high-strength~          core ceramic will exhibit good-to-excellent clinical performance (based on 11 evaluative~          criteria) and that they will adequately resist fracture in posterior situations~          (excluding third molars) if fabricated with the minimal connector size (4 mm x 4 mm).~        2. To test the hypothesis that a reinforced glass ionomer cement (ProTec CEM, Ivoclar,~          Vivadent), when used to cement core ceramic crowns in posterior FPDs, will be associated~          with significantly less marginal quality, but similar fracture resistance of the ceramic~          crowns compared with the marginal quality associated with a dual cure resin cement~          (Variolink® II, Ivoclar Vivadent AG, Schaan, Liechtenstein).~        3. To test the hypothesis that there is no significant difference in tooth sensitivity~          associated with FPDs cemented with the glass ionomer cement and dual-cure resin cement.~   "
254230|NCT00223418|"~     STUDY PURPOSE: To study whether patients who have schizophrenia or schizoaffective disorder~     and are randomly assigned to switch to aripiprazole prior to participation in a brief~     vocational skills training (VST) will have improved cognitive functioning and learn more in~     VST than those randomly assigned to stay on olanzapine. There is evidence that VST is~     important in improving role functioning for schizophrenia patients, however, cognitive~     impairments limit the ability of some patients to benefit from skills training approaches.~     Patients switched from olanzapine to aripiprazole improve in terms of verbal learning and~     verbal learning has been shown to be a strong predictor of community outcome. It is unclear~     whether the cognitive benefits of switching to aripiprazole extend to improve learning of~     vocational skills.~   "
254231|NCT00223405|"~     1. To characterize the microstructure (fracture toughness, particle size of ceramic, and~          inter-particle spacing) of three ceramic materials~        2. To test the hypothesis that lower fracture toughness of glass and/or crystal phase in~          ceramics reduce wear damage of enamel.~        3. To test the hypothesis that smaller sized crystals reduce wear damage of enamel.~        4. To test the hypothesis that larger inter-particle spacing reduces wear damage of enamel.~        5. To test the hypothesis that equivalent wear patterns exist in all directions between~          enamel versus enamel and ceramic versus enamel.~        6. To test the hypothesis that bite force does not correlate with wear rates.~        7. To test the hypothesis that salivary flow does not correlate with wear rates.~        8. To test the hypothesis that a greater amount of wear is not associated with a loss in~          vertical dimension of occlusion.~        9. To test the hypothesis that a greater amount of wear does not correlate with secondary~          cementum deposition as part of the passive eruption process.~       10. To test the hypothesis that maximum wear occurs early and wear rates level off within~          the first two years.~       11. To test the hypothesis that in vitro wear analysis does not correlate with in vivo wear~          measurements~   "
254232|NCT00223379|"~     This protocol is for a clinical trial evaluating the clinical success of root canal therapy~     performed on teeth with chronic apical periodontitis of pulpal origin with either large or~     small apical root canal preparation techniques.~   "
254233|NCT00223366|"~     This protocol is for a number of in vitro studies using human surgical biopsies and~     evaluating the pharmacology and genetics of human nociceptors (pain detecting) neurons~   "
254234|NCT00223353|"~     The overall purpose of this study is to develop an improved gait analysis system for the real~     time acquisition, calculation and interpretation of joint kinematic and kinetic information~     using linked segment body model animation to display and visually depict deviations from~     normal motion and joint function.~      Patients referred to the laboratory for clinical gait analysis are invited to participate in~     the project. If interested, subjects are informed by a study investigator of the study goals,~     procedures, risks and any benefits. A study investigator is responsible for obtaining~     informed consent. Data from normal subjects are used to establish a normative database. Data~     from other subjects contributes to the relevant databases of different disorders.~   "
254235|NCT00223340|"~     The purpose of this pilot study is to collect preliminary information about the best way to~     implement an intervention to reduce the risks of heart disease and stroke.~   "
254237|NCT00223314|"~     The purpose of the study is to adapt, implement, and evaluate an effective~     theoretically-based, high school HIV prevention program,Safer Choices, for higher risk youth~     in alternative schools.~      Primary Research Question~      1. Did the intervention reduce the number of occasions of unprotected sexual intercourse,~     number of sexual partners, and the proportion of students currently sexually active among~     those receiving the multiple component intervention relative to those students in the~     comparison group?~   "
254238|NCT00223301|"~     1. To determine the safety and tolerability of oral Cellcept when used in combination with~          weekly intramuscular Avonex in early MS.~        2. To document changes in exacerbation frequency,~        3. To document the incidence of mild, moderate, and severe exacerbations in the treated~          groups (categorical analysis),~        4. To document changes in the level of sustained disability as measured by the expanded~          disability status score (EDSS) and ambulation index (AI),~        5. To document changes in quality of life measures,~        6. To assess fatigue with the validated fatigue assessment inventory,~        7. Neuroimmunological studies:At baseline, 6 and 12 months after treatment~   "
254239|NCT00223288|"~     This study will examine if depression in a primary caregiver is associated with more~     hospitalization or ER visits in children with asthma. This study will also explore whether~     treatment for depression in the primary caregivers is associated with improvement in asthma~     in school-aged children.~      Asthma is a very common childhood disorder of airway inflammation. The causes include~     environmental irritants, cold temperature, and infection in the respiratory tract, and~     emotional factors can contribute to symptom exacerbation. However, asthma is a disease that~     can be well controlled if there is proper medication compliance and careful control of~     environmental conditions.~      Data suggests that psychiatric symptoms in the mothers of children with asthma are associated~     with more asthma related hospitalizations in children. Thus, we want to explore this question~     further using more specific diagnostic instruments in order to detect what types of symptoms~     are associated with increased asthma related service utilization. Also, we want to explore if~     effective treatment of the caregivers' symptoms is associated with decreased hospitalization~     and emergency room visits for the child.~   "
254240|NCT00223275|"~     The abuse of alcohol is especially common in people with bipolar disorder. However, very~     little is known about how to treat people with both bipolar disorder and alcohol~     abuse/dependence. The purpose of this research is to determine whether naltrexone add-on~     therapy is associated with a greater reduction in alcohol use and alcohol craving than with~     placebo (an inactive substance) therapy.~   "
254241|NCT00223262|"~     The purpose of this study is to determine if lamotrigine therapy is associated with~     improvement in mood, memory and hippocampal size and function in patients receiving chronic~     corticosteroid therapy. Standard care for mood changes associated with corticosteroid~     therapy, if severe, includes antidepressants or other medications which can influence mood.~     No therapies, other than dose reduction or discontinuation, are currently available for~     memory loss associated with corticosteroid treatment. However, very little information is~     available on the treatment of either mood or memory changes associated with corticosteroid~     treatment, thus the proposed project may improve standard care.~   "
254242|NCT00223249|"~     The abuse of alcohol is especially common in people with bipolar disorder. However, very~     little is known about the pharmacotherapy of people with both bipolar disorder and alcohol~     abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are~     decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine~     add-on therapy is associated with greater improvement in mood, impulsivity, functioning and~     decreased alcohol use than placebo.~   "
254243|NCT00223236|"~     The purpose of this research is to determine if a citicoline supplement is associated with a~     reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder~     marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar~     type (a psychotic disturbance in which there is a mixture of schizophrenic and~     manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore~     if citicoline supplements are associated with greater improvement in symptoms of mania and on~     memory and cognition (the mental faculty of perception, reasoning, and judgement) in these~     patients.~   "
254244|NCT00223223|"~     The purpose of this research is to determine whether the memory impairment and manic symptoms~     (feelings of agitation, overexcitement or hyperactivity) typically seen in those on~     corticosteroid therapy is decreased with a seizure medication called levetiracetam compared~     to placebo (an inactive substance). Since increased levels of cortisol (the body's natural~     corticosteroid) in the body are frequently associated with memory impairment interventions~     that may prevent or reverse this are of great importance.~      It is hypothesized that patients who are scheduled to receive prescription corticosteroid~     therapy who are given levetiracetam pretreatment will show lesser memory impairment and manic~     symptoms than those receiving placebo.~   "
254245|NCT00223210|"~     The purpose of this study is to determine if quetiapine add-on therapy is associated with a~     decrease in cocaine use and craving and a greater improvement in mood.~   "
254246|NCT00223197|"~     The purpose of this research is to determine if pregnenolone supplement is associated with a~     reduction in substance use and craving in patients with recurrent major depressive disorder~     or bipolar disorder and substance abuse/dependence. This research also wants to explore if~     pregnenolone supplements are associated with improvement in psychiatric symptoms and memory,~     which are often negatively affected in these patients. It is hypothesized that patients~     receiving pregnenolone supplements would show greater improvements in mood symptoms and~     memory, and crave substances less than the patients receiving placebo.~   "
254262|NCT00222989|"~     Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with~     functional Heartburn.~   "
254263|NCT00222976|"~     The primary objective of this study is to determine whether the route of administration of~     naproxen (either by mouth or rectally) influences post-vaginal delivery perineal pain~     control.~   "
254274|NCT00222833|"~     This is a 2-year study proposing to examine the effects of aripiprazole on heart health~     factors such as serum lipids, serum leptin, fasting blood sugar, body weight and blood~     pressure. This study also examines the safety of switching to aripiprazole with respect to~     changes in the clinical state, preexisting or emergent side-effects, how the brain processes~     information and changes in social functioning and quality of life.~   "
254247|NCT00223184|"~     At present, the only recognised prognostic factor for primary high-grade osteosarcoma is the~     histological response to preoperative chemotherapy. Our study was designed to identify new~     diagnostic markers that could eventually have a prognostic value and therapeutic~     consequences. 80 patients under 20 years of age with primary osteosarcomas were studied while~     under treatment by the French Society of Paediatric Oncology OS 94 protocol. Paired normal~     and biopsy samples were collected. In addition, surgical resection specimens, following~     preoperative chemotherapy, were obtained in many cases. After genomic DNA extraction, an~     allelotyping analysis targeting microsatellites was planned. The studied DNA regions~     contained mainly Rb, p53, APC, p16, c-met, TWIST, c-kit, erbB2 and topoisomerases genes. The~     techniques used in this molecular analysis comprised mainly allelotyping study, quantitative~     real-time PCR, gene sequencing , immunohistochemistry. The first results showed the~     prognostic value of 7q31 region containing c-met and 5q21 containing APC (Br J Cancer, 2003,~     Entz-Werlé et al.), 7p21 containing TWIST (Int J Cancer, 2005, Entz-Werlé et al.) and 4q21~     targeting c-kit gene (J Clin Oncol, 2005, Entz-Werlé et al.).~   "
254248|NCT00223171|"~     The objective of this study is to use as a reference the 36-month duration of hormonal~     therapy according to the European Organization for Research of the Treatment of Cancer (EORTC~     protocol 22863) : namely one-month of total androgen blockade followed by a luteinizing~     hormone releasing hormone (LHRH) agonist, all for three years, combined with pelvic and~     prostate irradiation; this arm is currently considered to be a standard for high-risk~     prostate cancers. The proposed study intends to challenge the duration of hormonal therapy~     and verify whether the five-year outcomes in favour of combined treatment in regard to~     survival (79% versus 62%) and local control (85% versus 48%) can be transposed for hormonal~     therapy that is half as long, namely 18 months, with the possibility of hormone salvage~     therapy in the event of biochemical and/or clinical failure (local, regional, or distant);~     this applies to both arms. The proposed study will compare survival in the two groups and~     evaluate in each one the total duration of initial hormonal therapy, followed by initial~     hormonal therapy combined with salvage hormonal therapy, the duration of salvage hormonal~     therapy until hormonal therapy resistance, and the side effects of this hormonal therapy,~     with everything being related to an assessment of the quality of life of these patients.~   "
254249|NCT00223158|"~     To compare the hypothyroid state in patients with thyroid cancer prepared either by placebo~     or L-T3 following L-T4 withdrawal in preparation for whole body scintigraphy. To evaluate the~     time needed for TSH elevation (> 30 mUI/L) on placebo vs. L-T3.~   "
254250|NCT00223145|"~     The hypothesis of the proposed study would be that, due to the six months of total androgen~     blockade, which would include neoadjuvant hormonal therapy for four months and concomitant~     hormonal therapy for two months with irradiation, the investigators could reduce local~     failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose~     to the prostate also seems to reduce local relapse rates, the results of the two hormonal~     therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy.~     This study would verify the possibility of compensating a six Gy dosage increase of radiation~     therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received~     hormonal therapy, and also match these results with a dose escalation to the prostate of 76~     Gy. In the future, this could result in more therapeutic choices, such as reducing the doses~     of radiation therapy and, consequently, its related complications, if hormonal therapy proves~     to be beneficial; or rather, to continue in the direction of dose escalation for this~     intermediate-risk patient group, everything being correlated to the side effects of hormonal~     therapy and irradiation.~   "
254251|NCT00223132|"~     The purpose of this study is to evaluate the effect of different suture material on the~     incidence of suture granuloma.~   "
254252|NCT00223119|"~     The purpose of this study is to determine the difference in pain scales between absorbable~     suture types for second-degree perineal laceration repair.~   "
254253|NCT00223106|"~     The primary objective of this study is to further evaluate the safety and effectiveness of~     the use of a sling device in women for stress and mixed urinary incontinence as well as~     vaginal vault prolapse.~   "
254254|NCT00223093|"~     Induce tolerance or reduce the amount of immunosuppression after renal transplant patient~     (receiving cadaver kidney)with so called TAIZ-monocytes~   "
254255|NCT00223080|"~     The purpose of this study is to determine whether immunizations with an integrated~     combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in~     healthy Thai volunteers.~   "
254256|NCT00223067|"~     reduce of immunsupression or introduce tolerance with so called TAIZ-monocytes in renal~     transplant patients~   "
254257|NCT00223054|"~     In this study the researchers want to investigate genetic polymorphisms of cytochrome 450~     enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for~     differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus,~     cyclosporine A).~      All patients who receive one of these drugs can be included and drug blood trough levels,~     dosing and genetics are compared.~   "
254258|NCT00223041|"~     Cardiovascular disease after renal transplantation is an important problem. Patients after~     renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no~     medication, to look for the cardiovascular outcome with and without statins.~   "
254259|NCT00223028|"~     To investigate in renal transplant recipients the potential drug intreaction between~     Sirolimus, Mycophenolt Mofetil and Fluvastatin~      All patient enrolled in this PKI-Study had no changes in the therapy before or because of the~     study. Only patients without changes more than 4 weeks before startin the study were included~   "
254260|NCT00223015|"~     Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal~     transplant patients are investigated to look for potential interaction between these drugs.~      All patient enrolled in this PKI-Study had no changes in the therapy before or because of the~     study. Only patients without changes more than 4 weeks were included~   "
254261|NCT00223002|"~     Infection after epidural catheter placement is fortunately rare. When it does happen, the~     affected person can become seriously ill.~      This study examines which skin disinfectant, chlorhexidine or povidone-iodine, decreases the~     number of bacteria that can be grown from the skin washed with each disinfectant prior to~     placing an epidural catheter for pain control in labour.~   "
254264|NCT00222963|"~     Obesity has reached epidemic proportions in the United States with roughly 20% of American~     children being overweight and has serious consequences such as sleep apnea.Additionally,~     obesity is known to result in the earlier onset of puberty . Thus, it can be expected that~     obese children take-on adult characteristics at an earlier chronologic age than their~     non-obese counterparts. Current guidelines recommend adenotonsillectomy (T+A) as primary and~     effective therapy for sleep apnea resulting in polysomnographic resolution in 75-100% of~     patients. Small studies have shown that T+A relieves symptoms in obese children but surgical~     intervention has been less efficacious in adults. We hypothesize that T+A may be less~     efficacious in obese adolescents because of earlier onset of puberty imparting more adult~     characteristics. We further hypothesize that the efficacy of T+A will correlate more closely~     with Tanner staging than with chronologic age because of the earlier onset of sexual~     maturation associated with obesity.~   "
254265|NCT00222950|"~     This study investigates the effect of margarines supplemented with plant sterol esters on~     serum and cardiovascular tissue concentrations of plant sterols. We assume that consumption~     of margarine supplemented with plant sterol esters increases serum and cardiovascular tissue~     concentrations of plant sterols (sitosterol; campesterol).~   "
254266|NCT00222937|"~     The study compares two different forms of voice therapy, Lessac-Madsen Resonant Voice Therapy~     and Casper-Based Confidential Flow Therapy. The target population are teachers because they~     have the highest risk for developing voice problems. For this study the investigators are~     primarily interested in seeing if Lessac-Madsen Resonant Voice Therapy (LMRVT) and~     Casper-Based Confidential Flow Therapy (CBCFT) are equally effective at improving vocal~     functioning in teachers with phonotrauma, as assessed by the Voice Handicap Index (VHI).~   "
254267|NCT00222924|"~     This investigation is being carried out to learn more about research findings from a study~     that was completed last year. Those findings revealed that within the skeletal muscle cells~     of individuals with type 2 diabetes, there was often damage to the mitochondria (the muscle~     cell's power source or the machinery of the muscle cell that produces energy). In individuals~     with type 2 diabetes, the liver continues to release sugar even when sugar levels are normal;~     the pancreas is not able to produce and release insulin normally; and the muscle and fat~     cells no longer respond as effectively to insulin. These defects lead to an abnormal rise of~     sugar in the blood. In this study, we want both to look more closely at the mitochondria and~     see if there is potential for improving mitochondrial functioning (improving the machinery of~     the muscle cell that produces energy) and reversing mitochondrial damage through a weight~     loss or a combined exercise/weight loss program. The program you get assigned to will be~     determined by a process called randomization (like a flip of a coin).~   "
254268|NCT00222911|"~     The overall purpose of this study is to examine the combined effect of both dorsiflexion~     night splints and medial arch supports and compare it to the effect of these interventions~     each by itself in the treatment of plantar fasciitis.~   "
254269|NCT00222898|"~     The purpose of this study is to assist with early and accurate diagnosis of cancer in~     pancreatic cysts based on the analysis of DNA obtained by endoscopic ultrasound guided fine~     needle aspiration~   "
254270|NCT00222885|"~     The purpose of this research is to develop a new method to study insulin action using~     positron emission tomography (PET). Insulin is the hormone made by your body to control the~     blood sugar level. We want to develop a way to image (look at) the following three things: 1)~     how insulin affects blood flow in skeletal muscle 2) how insulin affects glucose (sugar)~     transport (movement) into muscle, and 3) how insulin affects glucose metabolism (breakdown)~     in skeletal muscle of healthy individuals. The long term goal will be to later apply this~     method to the study of metabolic diseases, especially type 2 diabetes mellitus and obesity.~      PET imaging is a relatively non-invasive way to obtain a metabolic picture of body organs,~     and has been used successfully to study brain, heart and more recently skeletal muscle. In~     this research study, we will use PET with as many as four radioactive tracers (markers) to~     study skeletal muscle glucose transport in healthy volunteers.~   "
254271|NCT00222872|"~     The main purpose of this study is to determine the safety and effectiveness of three week~     daily subcutaneous injections of Parathyroid Hormone-related Protein (1-36). Previous studies~     indicated that PTHrP has a skeletal 'anabolic' or bone-building effect, and has shown to~     increase bone mineral density in postmenopausal women with osteoporosis. Safety of PTHrP will~     be determined by measurements of blood pressure and pulse, serum blood calcium levels and~     subjective symptoms. Effectiveness will be measured by changes in measurements of blood and~     urine markers of bone turnover.~   "
254272|NCT00222859|"~     The specific aims of this study are to determine the treatment prescription rates for~     Hepatitis C virus (HCV) infection in a cohort of HCV mono-infected, and human~     immunodeficiency virus (HIV)-HCV co-infected patients and to identify the reasons for~     non-treatment of HCV in these two groups.~   "
254273|NCT00222846|"~     This randomized study will test a behavioral intervention, based on social cognitive theory~     (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes;~     (1) those with well controlled blood glucoses and no concurrent chronic renal insufficiency,~     (2) those with less well-controlled glucoses and no chronic renal insufficiency, and (3)~     those with chronic renal insufficiency regardless of glucose control. The primary aims of~     this study are to: (1)determine whether the intervention improves behavioral adherence to the~     diabetes self-management regimen including dietary adherence, physical activity, and~     capillary glucose self-monitoring; (2)determine whether the intervention improves clinical~     outcomes; (3) explore the extent to which self-efficacy is a mediator of adherence,(4)~     explore the extent to which the effectiveness of the intervention varies with respect to~     glycemic control and nephrovascular complications at baseline, and (5)explore the impact of a~     variety of covariates on the effectiveness of the intervention.~      Hypothesis #1 is that intervention group participants will perform better than attention~     control group participants on various measures of adherence to the diabetes management~     regimen. Primary adherence variables will be dietary intake, and physical activity.~     Hypothesis #2 is that intervention group participants will have lower HbA1c levels than~     attention control group participants.~   "
254301|NCT00222456|"~     The purpose of this study is to examine whether an early intervention program may improve~     cognitive and behavioral short and longterm outcome in preterm infants.~   "
254275|NCT00222820|"~     We are doing this pilot study to learn more about four aspects of treating depression:~        1. The features of a depressed person’s mood and anxiety and how these features affect a~          person’s capacity to get better and stay better.~        2. If depressed people with certain features of mood and anxiety respond better to therapy,~          medication or a combination of therapy and medication.~        3. Whether or not a person’s personality traits affect how they respond to treatment.~        4. The gene involved in processing antidepressant medication~   "
254276|NCT00222807|"~     This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes~     mellitus in patients with schizophrenia. As part of the study, we collect~     neuroendocrine-immune data on patients with first episode, treatment naive psychosis,~     patients with newly diagnosed schizophrenia and normal healthy controls.~      Regardless the treatment status, we collect the same neuroendocrine-immune data on the~     participants after 2 months.~   "
254277|NCT00222794|"~     This study proposes to examine the effect of atomoxetine on quality of life and negative~     symptoms such as social withdrawal, lack of interest in things, lack of thought content, flat~     emotions, slowed body movements and lack of drive and motivation in patients with~     schizophrenia or schizoaffective disorder. This study also examines the safety of using~     atomoxetine along with the conventional antipsychotic in these patients.~   "
254278|NCT00222781|"~     The purpose of this research is to use a recently developed triple-tracer positron emission~     tomography (PET) method to study skeletal muscle insulin resistance. Insulin is the hormone~     made by your body to control the blood sugar level. Resistance' to insulin could cause poor~     blood glucose control (blood sugar levels that are higher than normal). We want to use this~     new method to image (look at) the following three things: 1) how insulin affects blood flow~     in skeletal muscle 2) how insulin affects glucose (sugar) transport (movement) into muscle,~     and 3) how insulin affects glucose metabolism (breakdown) in skeletal muscle of healthy~     individuals.~      PET imaging is a relatively non-invasive way to obtain a metabolic picture of body organs~     and has been used successfully to study brain, heart and more recently skeletal muscle. In~     this research study, we will use PET, with three radioactive tracers (markers), to study~     skeletal muscle glucose transport in individuals with type 2 diabetes mellitus (type 2 DM)~     and in non-diabetic individuals who are either normal weight or overweight/obese~   "
254279|NCT00222768|"~     The purpose of this research study is to use a relatively new technology, called Positron~     Emission Tomography (PET), to study how insulin works on sugar in your body's fatty tissue.~     PET imaging is a way of obtaining a metabolic image of your internal organs. It does not~     involve surgery and is not a high risk process. It has been used successfully to study brain,~     heart and more recently, skeletal muscle. In this research study, we will use PET in~     combination with Magnetic Resonance Imaging (MRI), to study fatty tissues in healthy people~     who do not have diabetes. In the future, we plan to do similar PET/MRI studies in individuals~     with type 2 diabetes mellitus (T2DM) and in individuals who are likely to develop T2DM.~      Fat tissue might have a lot to do with developing type 2 diabetes. First, it is well~     recognized that excess fatty tissues, especially the kind in your belly, increases risk for~     the development of T2DM, as well as affecting other ways the body uses insulin. Second, fatty~     tissue is a classic target tissue for the action of insulin, which regulates the use of sugar~     by fat cells and also regulates the release of fatty acids from fatty tissues. Third, studies~     in mice that lack fatty tissue, indicate that severe insulin resistance (lack of a normal~     response to insulin) can result. Other types of studies have shown that fatty tissues make~     proteins that affect your body's insulin and your appetite in good and bad ways. Yet despite~     this importance, we still lack techniques for the study of fatty tissue metabolism in humans.~   "
254280|NCT00222755|"~     The purpose of this research study is to learn whether or not a coordinated medical and~     psychiatric care program can improve outcomes of care for patients with bipolar disorder. We~     hypothesize that coordinated care via a Care Manager will improve physical and mental~     health-related quality of life, improve functioning, and reduce symptoms.~   "
254281|NCT00222742|"~     The primary hypothesis for this application for a multicenter phase III randomized clinical~     trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic~     brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months~     and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).~   "
254282|NCT00222729|"~     The purpose of this study is to determine if the combination of two new drugs pemetrexed~     (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and~     neck cancer. Currently pemetrexed is approved by the Food and Drug Administration (FDA) for~     another type of cancer, mesothelioma, but it is not approved for head and neck cancer.~   "
254283|NCT00222716|"~     The primary aim of this study is to compare the effect of an individualized adherence~     intervention (TI) and a structured adherence intervention (TS) to usual care on adherence to~     antiretroviral therapy in persons infected with HIV (PWHIV).~   "
254284|NCT00222703|"~     The primary aim of this study is to examine the efficacy of a 12-week nurse-delivered relapse~     management intervention designed with conceptual underpinnings from Self-efficacy Theory to~     enhance smoking abstinence of hospitalized smokers following their hospital discharge.~     Specifically this study asks, does a 12-week Self-efficacy Theory driven relapse management~     intervention enhance smoking abstinence following hospitalization by increasing smoking~     abstinence point prevalence as measured by carbon monoxide validated self-reports of smoking,~     when compared to subjects receiving only enhanced usual care?~   "
254285|NCT00222690|"~     The purpose of this study is to conduct semi-structured qualitative interviews to examine the~     personal experiences of women living with fibromyalgia. The specific aims of this study are~     to identify clinically relevant “triggers” of fibromyalgia symptoms and examine their impact~     on activity limitations and participation restrictions.~   "
254286|NCT00222677|"~     To determine whether aspirin is more effective than placebo for the prevention of recurrent~     symptomatic venous thromboembolism when given for at least two years after the initial 6-12~     month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism~   "
254302|NCT00222443|"~     Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with~     weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles~     of this chemotherapy and to estimate the response rate to this combination in children and~     adolescents with recurrent solid tumors and lymphomas.~   "
254287|NCT00222664|"~     During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of~     birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and~     standard vaccination plus a booster dose at about 2 to 3 years of age. The aim is to prevent~     establishment of chronic HBV infection in early childhood, hence to prevent the morbidity of~     chronic hepatitis B in young adolescents and the incidence/mortality several decades later~     from liver cancer and other HBV related chronic liver diseases. Long-term follow-up through~     central registries will determine the impact of vaccination on liver cancer incidence and~     mortality.~   "
254288|NCT00222651|"~     To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients~     with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving~     unfractionated heparin (UFH)~   "
254289|NCT00222638|"~     The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage~     variations after Influenza Vaccination~   "
254290|NCT00222625|"~     Evaluation of efficacy and safety of recombinant factor VIIa versus standard therapy in~     preventing early haematoma growth in spontaneous acute intracerebral haemorrhage in patients~     treated with oral anticoagulants or antiplatelets agents~   "
254291|NCT00222612|"~     A randomised trial for children with acute lymphoblastic leukemia, using the detection of~     minimal residual disease to define risk groups, aiming to answer the questions:~        1. Can treatment be reduced without compromising efficacy in a MRD-defined low risk group?~        2. Does further post-remission intensification improve outcome for a MRD-defined high risk~          group?~        3. Measure the Quality of Life impact of the different treatment arms on the children and~          their families.~   "
254292|NCT00222573|"~     COMMIT/CCS2 is a large randomised trial of the effects of clopidogrel plus Aspirin versus~     Aspirin alone in acute heart disease. Patients presenting within 24 hours of the onset of~     suspected acute MI were potentially eligible provided they were thought to have ST elevation~     or other ischaemic ECG abnormality with no clear indication for, or contraindication to,~     trial treatment. All patients were to be given 162 mg ASA daily and, in addition, 75 mg~     clopidogrel daily or matching placebo for 4 weeks or until prior discharge or death.~     (Patients were also randomised separately in a 2 X 2 factorial design between metoprolol~     versus placebo.) The two main study endpoints are death and the composite outcome of death,~     non-fatal reinfarction or stroke during the scheduled treatment period in hospital.~   "
254293|NCT00222560|"~     The Physical Activity Counselling (PAC) randomized controlled trial had as overall goal the~     establishment of a collaborative interdisciplinary primary care team to encourage physical~     activity. The main intervention was to integrate a physical activity counsellor to the~     primary care team so that the most appropriate care was given by the most appropriate~     provider. Much research has shown and many experts agree that patients need significant help~     to make and especially maintain physical activity behavior changes. Maintenance of these~     changes is essential for optimal health benefits. It was predicted that patients receiving~     both brief (2-4 minute) physical activity counselling from their family physician and~     intensive (3 month) physical activity counselling from an integrated physical activity~     counsellor (intensive counselling group) would report greater improvements in task motivation~     and task self-efficacy to engage in physical activity at the end of the intervention than~     those receiving only brief counselling (brief counselling group). The same was expected for~     both self-reported and objective physical activity. This RCT involved testing a theory-based~     counselling intervention, determining why the intervention was effective or ineffective by~     measuring key psychological mediating variables, using an objective measure to track changes~     in physical activity, and assessing physical and metabolic outcomes. This project represents~     an innovative theoretically based multi-level multi-intervention approach to promoting~     physical activity in primary care and is of great public health importance.~   "
254294|NCT00222547|"~     Randomisation of 72 large rural areas (blocks) into a 2 x 2 trial of six- monthly treatment~     of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or~     neither. The placebo group get no trial treatment at all and do not receive physical~     placebos.~   "
254295|NCT00222534|"~     Respiratory failure is a common consequence of chronic obstructive pulmonary disease (COPD).~     A concurrent metabolic alkalosis may worsen the respiratory failure, as a higher pH in blood~     (and thus in cerebrospinal fluid) results in a weaker respiratory drive. Use of diuretics is~     the most common cause of metabolic alkalosis.~      When a patient with an acute exacerbation of a respiratory failure is also alkalotic, there~     are (at least theoretical) reasons to lower the pH in order to increase the respiratory~     drive. Among other alternatives, the drug acetazolamide can be used for this purpose.~      In some hospitals there is a tradition for the use of acetazolamide on this indication, but~     any evidence for the effect of such a treatment is rather weak.~      Thus, the aim of this trial is to evaluate the effect of acetazolamide as an adjuvant~     treatment for hospitalized patients with acute exacerbation of respiratory failure in~     combination with metabolic alkalosis.~   "
254296|NCT00222521|"~     This Study is designed to determine whether treatment of CFRD with glargine insulin will~     improve hemoglobin A1c, weight and muscle mass compared to the traditional regimen of bedtime~     NPH insulin.~   "
254297|NCT00222508|"~     Our general aim is to determine the prevalence of diabetic microvascular complications in~     CFRD patients with and without fasting hyperglycemia, and to explore whether the presence of~     these complications is related to diabetes or CF factors. This cross-sectional study will~     provide pilot data for a longitudinal study of diabetes complications in CF.~   "
254298|NCT00222495|"~     The overall goal of this study is to determine the efficacy and tolerability of three~     atypical antipsychotic medications (risperidone, olanzapine, and quetiapine) in the treatment~     of adolescents with psychosis. It is hypothesized that the three medications will be equally~     effective in reducing the symptoms of psychosis.~   "
254299|NCT00222482|"~     This study examines the effect of Depakote ER versus placebo in a randomized trial of~     borderline personality disorder. Patients all participate in DBT therapy and those who are~     not responsive are assigned to either Depakote ER or placebo for up to 12 weeks. Borderline~     Personality Symtoms are measured and side-effects are assessed.~   "
254300|NCT00222469|"~     The purpose of this study is to find out if giving patients bevacizumab along with the~     chemotherapy drugs oxaliplatin and gemcitabine will improve overall survival.~      In addition, the study will find out what side effects patients may have by taking~     bevacizumab, oxaliplatin, and gemcitabine together.~   "
254303|NCT00222430|"~     The purpose of this study is to compare the use of fluoroscopic guidance, (a commonly used~     X-ray technique), with the traditional approach, (where the doctors feel for the strongest~     pulse), to obtain access to the blood vessel in the groin. These two methods are being~     compared to assess which is faster, safer and more often allows your physician to use an~     arterial closure device, a small suture or plug applied at the end of the angiogram where~     the needle enters your blood vessel if he/she chooses.~   "
254304|NCT00222417|"~     We study audiometric parameters including Transient Otoacoustic emissions, pure-tone~     audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air-~     and bone conduction in a pre- and postoperative situation in patients due for surgery for~     tympanic membrane perforations and otosclerosis. The hypotheses are that the precision of the~     preoperative assessment may be increased, and our knowledge about the effect on the inner ear~     by middle ear surgery may be increased.~   "
254305|NCT00222404|"~     The purpose of this study is to correlate molecular genetic profile with response to~     chemotherapy in case of primary chemotherapy treatment for non-small cells lung carcinoma.~   "
254306|NCT00222391|"~     The purpose of the study is to evaluate the impact of epidural anesthesia on sympathetic~     activity in surgical patients. The study investigates whether a segmental sympathetic block~     can be determined and can be correlated to level of the sensoric blockade.~   "
254307|NCT00222378|"~     An increase prevalence of CMV, EBV and or HHV-6 in diseased tissue of inflammatory bowel~     disease would suggest a role for these viruses in the etiology and/or exacerbation of IBD,~     whereas their absence would preclude such association.~   "
254308|NCT00222365|"~     This is an add-on, double blind, and randomised clinical trial with three groups: a~     homeopathic group, a placebo group, and a temporal control group.~      The aim of this trial is to assess the effect of homeopathy on the consumption of morphine~     delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.~   "
254309|NCT00222352|"~     In a randomized, controlled clinical trial, point-of care testing at the bedside using the~     cardiac biomarker troponin I in ED patients with possible ACS will be compared to traditional~     testing of this assay for myocardial necrosis obtained in the central laboratory. Our~     hypothesis: point-of-care testing for troponin I will decrease the time for disposition of~     patients with possible ACS in the emergency setting and decrease the time required for~     administering appropriate therapies for these patients.~   "
254310|NCT00222339|"~     Stroke is the leading cause of long-term physical disability in Australia. Currently around~     25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired~     use of the affected hand with consequent dependence in dressing, grooming and feeding~     themselves. The poor outcome can be attributed in part to a lack of focus by therapists on~     the negative signs of stroke (weakness and lack of dexterity) as well as too little time~     (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very~     limited evidence base to guide the content of clinical practice. Results from both animal and~     human studies suggest that specific post-lesion training can result in substantial~     improvement in function. The hypothesis is that task-specific training of the affected upper~     limb to subjects in the early period following stroke will result in significantly better~     functional outcome than standard intervention.~   "
254311|NCT00222326|"~     Optimal pelvic floor muscle function is known to assist bladder and bowel function and~     control, pelvic organ support, as well as other areas of health. It is also known that~     problems in some of tehse areas can be a consequence of pelvic surgery. By addressing the~     requirements for good bladder and bowel function/control, and organ support in the early~     post-surgery phase when tissue repair and scar formation are critical, it is proposed that~     there will be a rduction in the longterm prevalence of bladder problems, bowel difficulties~     and weakened pelvic floor and abdominal muscles in post-surgery patients. This study is a~     randomised controlled trial to compare patients undergoing a physiotherapy-supervised pelvic~     floor muscle training and behavioural therapy program with a control group. It is~     hypothesised that at the 12 month post-operative follow-up assessment, the treatment group~     will demonstrate better outcomes in bladder and bowel function and control, as well as~     stronger pelvic floor muscle contractile strength than the control group.~   "
254312|NCT00222300|"~     Total Hip Replacement (THR) is a common surgical procedure performed in people with hip~     osteoarthritis and appears to be effective in relieving pain and improving function. However~     significant wasting and weakness of the hip and knee muscles persists post-operatively.~     Although relief of pain and improvement of function are important outcomes following THR,~     weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes,~     public transport and results in persistent gait abnormalities. Since lower limb weakness is~     one of the risk factors for falls, it is important that patients undergo a strengthening~     program post-operatively. The hypothesis is that lower limb strength and function will be~     better in patients who undergo a strengthening program post-operatively than in those who~     have usual care.~   "
254313|NCT00222287|"~     The purpose of this study is to investigate the effects of a series of Feldenkrais movement~     lessons on mobility and balance, particularly for older adults. The investigators hypothesise~     that mobility and balance will improve following the classes.~   "
254314|NCT00222274|"~     A growing body of evidence suggests that the symptoms of many fibromyalgia syndrome (FMS)~     sufferers might be the result of an imbalance in one of the major stress response systems,~     the autonomic nervous system. Thus respiratory sinus arrhythmia (RSA) biofeedback, which has~     shown promise in other conditions associated with an autonomic nervous system imbalance,~     could be effective in FMS. With the aid of sensors and computers, biofeedback involves~     modifying and/or learning how to control normally involuntary processes like blood pressure,~     heart rate and the autonomic nervous system through relaxation and breathing. The goal of~     this study is to test the effectiveness of a 10-session RSA biofeedback treatment for the~     symptoms of fibromyalgia. Forty patients receiving the RSA biofeedback treatment will be~     compared to 40 patients receiving another form of biofeedback thought to be minimally helpful~     (control group). Later, control group patients will also receive the RSA biofeedback~     treatment. We will study improvement in symptoms like pain, fatigue, sleep disturbance and~     depression in the RSA biofeedback group and compare these improvements to those in the~     control group. We will also assess whether these improvements persist over time and what if~     any changes in the autonomic nervous system result from the treatment.~   "
254315|NCT00222261|"~     In the ASCET study, 1000 patients with documented coronary heart disease will be randomized~     to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d. Clinical~     endpoints will be recorded for at least 2 years and related to the initial aspirin response,~     assessed by the PFA-100® method, to investigate whether aspirin non-responders have higher~     composite event rate than responders or whether Clopidogrel treatment in patients~     non-responsive to aspirin will reduce their risk of future clinical events. The clinical~     events are the composite of unstable angina, myocardial infarction, stroke or death.~   "
254316|NCT00222248|"~     To determine the effect of pelvic floor muscle training in women aged 70 years and over, who~     have proven stress urinary incontinence. The hypotheses to be tested are:~        1. That pelvic floor muscle training is effective in relief of symptoms of stress urinary~          incontinence as measured by a greater reduction in the number of episodes of~          incontinence, quantity of urine lost and improvement of quality of life.~        2. That women who undertake pelvic floor muscle training will show greater improvement of~          pelvic floor muscle function than women who have behavioural (bladder) training, as~          measured by real time transabdominal ultrasound.~   "
254317|NCT00222235|"~     This study will determine the effectiveness of treatment with glycine or d-cycloserine in~     addition to a normal antipsychotic regimen in improving negative symptoms and cognitive~     impairments in patients with schizophrenia.~   "
254318|NCT00222222|"~     Aims of the study were to find vascular markers of inflammation and endothelial damage during~     the course of severe sepsis in septic patients and the effects of treatment with~     anti-inflammatory medication (such as Drotregocin alfa (activated)). Another aim is to find~     new markers and gene polymorphisms for prognosis and mortality of patients with severe~     sepsis. The hypothesis is that higher plasma concentrations of certain markers in septic~     patients are associated with a higher mortality rate.~   "
254319|NCT00222209|"~     The project investigates on the role of pain avoidance, comorbidity and stress response for~     the development of chronic somatic and visceral pain. We, the researchers at University~     Hospital Mannheim, assume that implicit operant learning of pain sensitization is a central~     mechanism of the process of pain becoming chronic, which is augmented by fear and by~     avoidance behaviour. Somatic and psychological comorbidity as well as stress factors are~     further promoting factors in chronic pain development.~   "
254320|NCT00222196|"~     Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple,~     effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with~     peripheral occlusive disease.. However, the fact remains that the indication for performing~     PTA are still more based on opinions than on scientific data.~      The purpose of the trial was to randomize patients primarily referred for intermittent~     claudication into two groups: One group was offered conservative treatment; the other group~     was offered conservative treatment combined with PTA.~      Primary outcome: The patient quality of life. Secondary outcome:Pain-free walking distance;~     pain-score; death; amputation; changes in relevant biomarkers~   "
254321|NCT00222183|"~     This trial evaluates the therapeutic effect of Elidel (pimecrolimus) in comparison to the~     corresponding vehicle in patients with chronic discoid lupus erythematosus (dLE) or subacute~     cutaneous lupus erythematosus (scLE).~   "
254322|NCT00222170|"~     The purpose of this study is to determine the production of mucin in GERD/RE subjects before~     and after 8 weeks of treatment with rabeprazole.~   "
254323|NCT00222144|"~     The primary goal of this study is to determine the effects of the combination of Gleevec and~     Taxotere in lung cancer in terms of control and reduction of the cancer size. The study will~     also test lung cancer to see if the presence of certain protein called receptor for platelet~     derived growth factor can influence the effect of the treatment.~   "
254324|NCT00222131|"~     Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in~     NUD patients~   "
254325|NCT00222118|"~     Breastfeeding initiation and duration in adolescent mothers.~   "
254326|NCT00222105|"~     Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone~     for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and~     autologous stem cell transplant.~   "
254327|NCT00222092|"~     Octreotide, somatostatin and pentoxyfilline commercially available drugs that are used in~     various clinical situations. They are safe and known for years. Octreotide and somatostatin~     have been used in many studies for the prophylaxis and treatment of pancreatitis and~     post-ERCP pancreatitis, while pentoxyfilline has shown effect on patients with alcoholic~     hepatitis, obstructive vasculitis etc. The aim of the study is to evaluate the efficacy of~     any of those treatments for the prophylaxis and treatment of post-ERCP pancreatitis. In~     addition some molecular markers of acute and chronic inflammation will be measured before and~     after the endoscopic procedures according to the study protocol.~   "
254328|NCT00222079|"~     The purpose of this research study is to measure acid reflux into the throat both before and~     after medical treatment in people who have had radiation therapy to their head and neck for~     the treatment of cancer. Many people who have received head and neck radiation therapy~     develop a dry mouth as a result of the radiation damage to their saliva glands. In addition~     to the discomfort associated with a dry mouth, the decrease in saliva may increase the~     severity of gastro-esophageal reflux disease (acid reflux). Acid reflux occurs when acid~     escapes from your stomach into your throat. You may not have any symptoms of acid reflux, but~     often it can cause symptoms of heartburn or chest discomfort.~      Acid reflux can be treated once it is diagnosed. Treatment consists of dietary changes,~     behavioral alterations, and medication. Medications are available that decrease the amount of~     acid in your stomach. Diagnosis of acid reflux is made with a pH-probe to test for acid in~     your throat.~   "
254329|NCT00222066|"~     The purpose of this study is to determine whether prenatal ovarian cyst aspiration is~     effective and safe to prevent perinatal ovarian torsion.~   "
254330|NCT00222053|"~     Principal objective is to evaluate the impact of Thalidomide to prolong the duration of~     response after autologous transplantation for myeloma~   "
254331|NCT00222040|"~     To determine whether transcranial 2-MHz ultrasound combined with intravenous administration~     of microbubbles improves early recanalization in patients with acute ischemic stroke caused~     by middle cerebral artery (MCA) proximal occlusion treated with intravenous alteplase within~     3 hours of symptom onset.~   "
254332|NCT00222027|"~     Several prognostic predictors, including baseline ALL features and response to initial~     therapy, have been described in adult ALL raising the issue of whether these predictors might~     be redundant and which must be considered for treatment stratification. In the GRAALL-2003~     prospective Phase 2 study, we aim to hierarchize the following high-risk factors in~     Ph-negative ALL patients.~   "
254333|NCT00222014|"~     The main end point of the study is to assess survival in cirrhotic patients with refractory~     ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis +~     albumin infusion.~   "
254334|NCT00222001|"~     The advance of communication technology has changed medical practice. The concept of medical~     telemedicine centers receiving, assessing and managing calls from patients or their carers on~     a 24 hour, 7 days a week basis is spreading in the US as well as in European countries.~     Usually specially trained nurses using dedicated decision support software provide the~     service. One aspect is the so-called triage, i.e. the decision on urgency and optimal~     treatment path of a stated medical problem, which has the potential to contain overall~     treatment costs.~      Despite proliferation of these services, little is known about the quality of the services~     provided.~      In October 2000 the first 24-hour medical telemedicine centre staffed by medical doctors~     started operating in Switzerland. The aims of this study are to assess the quality of service~     provided by doctors using decision support software and to determine potential predictors of~     incorrect triage.~   "
254335|NCT00221988|"~     Epilepsy is a common disorder with an incidence of about 6 per 1000. The incidence~     progressively increases above age 50. By age 75, the incidence is two to three fold compared~     with any age group. Unfortunately, older individuals are especially at risk to incur~     significant side effects to anti-epileptic drugs. A newer anti-epileptic drug may markedly~     improve seizure management in older individuals as it is removed by the kidneys and not the~     liver and does not interact with other medications. We expect it to be tolerated well in~     terms of effects on memory, thinking,balance, and walking. The current study assesses the~     side effects of levetiracetam in healthy volunteers aged 65 to 80. Use of healthy volunteers~     eliminates the effects of seizures on the outcome.~   "
254336|NCT00221975|"~     Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and~     females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar~     disorder (type I or II) and who have met the criteria for substance abuse or dependence of~     cocaine, marijuana and/or alcohol within the past six months. Patients begin treatment with a~     combination of lithium and divalproex. Once these medications are tolerated, they are~     randomly assigned to double-blind treatment with lamotrigine or placebo. Patients remain in~     this study until they experience a marked bimodal response for four consecutive weeks. This~     study is sponsored by the Stanley Foundation.~   "
254337|NCT00221962|"~     To look at the cognitive effects of abilify in children with a primary diagnosis of Attention~     Deficit Hyperactivity Disorder. To examine the safety, effectiveness and tolerability of~     abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder.~   "
254338|NCT00221949|"~     Peripheral nerve blocks of the limbs are very useful in providing anesthesia and pain relief~     for orthopedic procedures in the limbs (elbows, arms, knees, and legs). Considering that~     current nerve block techniques involve locating the main nerves at the top of the limb and~     freezing those neural structures in order to provide pain relief to the rest of the~     extremity, a comprehensive study of the nerves located lower in the limbs is needed. This~     study provides a step in the direction of the development of techniques for advanced nerve~     blockade that target nerve structures lower in the limbs to provide precise pain relief~     rather than widespread numbness.~      The objective of the study aims to use direct ultrasound guidance to develop a comprehensive~     examination and identification of the peripheral nerves in the lower region of the upper and~     lower limbs (arms and legs). In a sense, this process allows us to visualize the nerves. In~     the future, with the experience of visualizing these nerves with the ultrasound machine, we~     can develop techniques that may allow us to perform anesthetic blockade with greater success~     and fewer complications.~      An ultrasound exam will be performed on 8 healthy volunteers to view the peripheral nerves in~     the lower arm in three locations: the elbow area, the wrist area, and the midpoint of the arm~     between the elbow and the wrist. A set of 8 healthy patients will be given an ultrasound exam~     to view the peripheral nerves located in the lower leg by imaging three locations: the knee~     area, the ankle area, and the midpoint of the leg between the knee and the ankle. The~     appropriate nerves will be identified by ultrasound and images will be captured and recorded~     for further corroboration. The group of 16 subjects will allow for varied observations of~     anatomical positions of neural and vascular structures, while keeping the sample size fairly~     small. No injections will be made at any time during this study.~   "
254339|NCT00221936|"~     Patient Centered Care (PCC) is an approach that consciously adopts the patient's~     perspective...about what matters (Gerteis, Edgeman, Levitan, Walker, Stokes, Cleary,~     Delbanco, 1993). Experiencing pain is the most common concern of patients before surgery -~     even ahead of whether the surgery would improve their condition (Apfelbaum, 2003). Current~     standard of practice for post-operative pain management in most acute care hospitals today is~     intravenous patient controlled analgesia (IV PCA). However, despite the fact that patients~     prefer IV PCA because it affords them greater control and provides them with better pain~     relief (Ballantyne, Carr, deFerranti, Suarez, Lau, Chalmers, Angelillo, Mosteller, 1998 ;~     Rawal, 2001), hospitals routinely take control of pain medications away from patients once~     they are switched to pain tablets. Patients must then wait, in pain, for their nurse to bring~     them pain tablets.~      Patient controlled oral analgesia (PCOA) has been utilitzed in several centers in the US and~     Germany. Preliminary evidence from the literature seems to indicate that the benefits of PCOA~     are similar to IV PCA including increased patient satisfaction and better pain control~     (Striebel, Romer, Kopf, Schwagmeier ,1996; Striebel, Scheitza, Philippi, Behrens, Toussaint,~     1998). At the Toronto Western Hospital, University Health Network, we have successfully~     implemented a PCOA program on two surgical units (Orthopedics/Rheumatology and Spinal). The~     purpose of this study is to compare usual nurse administered oral analgesia to PCOA with~     respect to pain, patient satisfaction, and passive range of knee motion in postoperative~     total knee replacement patients.~   "
254340|NCT00221923|"~     According to the National Eye Institute, Glaucoma affects about three million Americans.~     Among Blacks in the United States, open- angle glaucoma is the leading cause of irreversible~     visual loss. Glaucoma is four times more likely to develop in Blacks than in Whites.~      This is a prospective longitudinal, multi- site observational cohort study designed to obtain~     visual function and optic nerve structure data on eyes of Black and White Americans. The~     investigators will evaluate the relationship between changes in the structure of the eye and~     the vision loss caused by glaucoma.This is the first study where both populations are matched~     for quality of care and equal access to care.~   "
254513|NCT00219674|"~     The purpose of the research is to determine the best automated external defibrillator (AED)~     training approach for high-risk patients and their family members with regard to AED skills~     retention and psychological adjustment.~   "
254341|NCT00221910|"~     Nerve freezing injections of the leg are very useful in providing anesthesia and pain~     relief for knee and ankle surgery. However, current nerve freezing techniques are blind.~     As a result, they are not always successful and may cause complications, albeit infrequent.~      The objective of the current study is to determine any advantage in performing these~     freezing injections under direct ultrasound guidance, to visualize the nerves. We feel~     that by developing this technique, it will allow us to perform these procedures with greater~     success and fewer complications.~   "
254342|NCT00221897|"~     A prospective, longitudinal observational cohort study evaluating the relationship between~     changes in the structure of the eye and the vision loss caused by glaucoma. There are two~     main parts to the study: 1) Visual Function and 2) Optic Nerve Structure~   "
254343|NCT00221884|"~     Many patients undergoing surgery on their hand receive a form of anesthetic called axillary~     brachial plexus block. This involves the injection of local anesthetic (freezing medication)~     around the nerves that supply the upper limb, which are located in the arm pit. The technique~     currently used by physicians performing this procedure is far from perfect, and in up to 1 of~     every 5 patients it does not work well enough to allow surgery, and a different form of~     anesthetic may need to be used.~      In an attempt to improve these results, we have recently developed a new technique, using~     ultrasound imaging to see the nerves prior to giving the injection. Our initial results are~     very promising, implying that this may be a highly successful and safe approach. The purpose~     of this study is to determine if this technique is indeed more successful. In order to do~     that, we will ask 110 patients for their participation. They will be divided in two groups,~     at random. One group will receive the standard technique (transarterial, using a small needle~     to find the artery that is close to the nerves). The other group will receive the injection~     after identifying the nerves with ultrasound imaging. They will all receive the same type of~     medication, and they will be tested every 5 minutes for half an hour to determine if the~     block has been successful, according to pre-established criteria. Their pain control will be~     assessed after the surgery and they will be called 24 hours and 1 week after the surgery to~     assess their recovery and rule out any possible complications.~   "
254344|NCT00221871|"~     Ketamine added to Lidocaine can increase duration of pain relief following intraveonous~     regional anesthesia (IVRA). The purpose of this dose response study is to determine the~     minimum effective dosage of intravenous Ketamine, added to 3 mg/kg of Lidocaine. We~     anticipate that one dosage will provide us with the proper balance between sufficient~     anesthesia and minimal side effects.~   "
254345|NCT00221858|"~     This is a quality assurance database to prospectively examine regional anesthesia outcomes at~     Toronto Western Hospital.~   "
254346|NCT00221845|"~     In children with chronic kidney disease, progression to end-stage renal failure is associated~     with high patient morbidity and poor quality of life. In adults, inhibition of the renin~     angiotensin system (RAS) slows down the rate of renal failure progression. This concept is as~     yet unproven in children, in whom chronic renal failure (CRF) is more commonly due to~     hypo/dysplastic malformations than to acquired glomerulopathies as typical for adult chronic~     kidney disease. The current project aims at assessing the genetic and molecular mechanisms~     and cardiovascular consequences of progressive CRF and to develop a strategy of~     pharmacological renoprotection in children.~   "
254347|NCT00221832|"~     The aim of this study is the identification of familial congenital arrhythmogenic disorders~     and their clinical follow-up.~   "
254348|NCT00221819|"~     To humidify gases during non invasive ventilation, both to heated humidifier (HH) and heat~     and moisture exchanger (HME) are routinely used. Patients receiving non invasive ventilation~     for acute respiratory failure were randomized to HME or HH. The purpose of this study was to~     evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with~     small dead space HME compared to HH.~   "
254349|NCT00221806|"~     The aim of this project is to improve the hemocompatibility of vascular prosthesis with a~     complete covering of its endoluminal surface with autologous endothelial cells. The objective~     is to obtain a better bypass permeability with arterial prosthesis replacing low diameter~     vessels in lower limbs~   "
254350|NCT00221793|"~     The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and~     to study its link with an energetic balance change.~   "
254351|NCT00221780|"~     Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and~     mortality in heart failure patients. However, very few is known about the importance of the~     left ventricular pacing site. We study in a random order 11 different left ventricular pacing~     sites and compare their hemodynamics using pressure-volume catheters. The consequences on the~     surface ECG are also assessed.~   "
254352|NCT00221767|"~     Bladder dysfunction is a major problem in patients with complete spinal cord lesions. For~     patients presenting incontinence or risk for kidney, two major conventional alternatives are~     possible : conservative therapies (muscarinic receptor antagonists, vanilloids drugs and~     botulinum toxin in association with catheterization) and surgical techniques intervening in~     the nervous and urinary system.~      Among these last alternatives, the Brindley technique (anterior sacral root stimulation with~     posterior rhizotomy) is the only technique allowing for the restauration of bladder function,~     continence, and micturition. The purpose of the study is to compare the Brindley technique~     with the first conventional approach in France from a medical and economical point of view.~   "
254353|NCT00221754|"~     To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with~     protease inhibitors in a randomised double blind study.~   "
254354|NCT00221741|"~     Despite experts' recommendations, the consumption of Fresh frozen plasma (FFP) is very~     heterogeneous among French cardiac surgery centers. This probably reflects heterogeneous~     practices that are not characterized and whose outcomes on morbidity and mortality are not~     documented.~      The principal objective of the study is to describe transfusional strategies of FFP in~     patients undergoing cardiac surgery. The other objectives are: to assess the conformity of~     FFP transfusion or lack of transfusion to current French authorities' recommendations, to~     describe the post-operative mortality and morbidity and to assess the prognostic role of FFP~     on mortality and morbidity. Prognostic analyses will take into account other prognostic~     factors of mortality and morbidity.~      1500 patients undergoing cardiac surgery and presenting with a serious bleeding (or~     transfused with FFP without bleeding) will be included in the study.~   "
254355|NCT00221728|"~     Surgical treatment of multiple or recurrent renal tumors may be complicated by renal function~     impairment. Mini-invasive thermotherapy as radiofrequency (RF), induces necrosis of tumoral~     tissue while sparing normal renal parenchyma. The purpose of the study is to compare, in~     patients at risk of renal insufficiency, a strategy based on surgical approach and a strategy~     based on RF approach. 180 patients from 9 centers will be randomized in two groups (surgical~     vs. RF, delivered either percutaneously or under laparoscopy). The proportion of patients~     with a local carcinologic efficacy at 5 years and the general and renal tolerance will be~     analysed and compared between both strategies.~   "
254356|NCT00221715|"~     When medical treatments fail, critical ischemia of the lower limb often leads to surgery,~     i.e. above knee femoro popliteal bypass. This bypass can be performed either with DACRON or~     PTFE prosthesis or with the autologous saphenous vein. Both technics are used but they have~     not been compared regarding bypass permeability and limb salvage. Thus, this study will~     compare the permeability rate of above knee femoro popliteal surgery whether performed with~     autologous vein versus prosthesis~   "
254357|NCT00221702|"~     Melanoma with a tumor thickness >= 1.5mm without clinically detectable nodes represents an~     increasing population with relapse rate of more than 50%. Adjuvant therapy with low doses of~     IFN alpha can provide a benefit in this group. However, the impact of low dose IFN alpha is~     not sustained after the treatment period. A longer treatment may prolong the benefit and thus~     have a more clear-cut impact on disease-free and overall survival. The tolerance and the~     impact on quality of life are limiting factors in a group of patients whose individual course~     is not necessarily poor. PegIntron may be better tolerated than instant release interferon,~     and thus make this treatment more acceptable in terms of toxicity and quality of life. Thus~     treatment schedule with PegIntron is not expected to increase the cost of standard care~     significantly.~   "
254358|NCT00221689|"~     Within the framework of a prospective double-blind and randomized study evaluating the~     efficacy of continuous intrathecal baclofen therapy (CIBT) on paroxysmal dysautonomia (main~     objective) and hypertonia, recovery and tolerance (secondary objectives) during the initial~     recovery phase of severe head injury, continuous intrathecal baclofen infusion will be~     delivered. The first week of study is double-blind: the first of two parallel groups receives~     CIBT and the second group receives placebo. The main outcome (number of neurovegetative~     episodes) is assessed at the end of first week. The second week of study is open labeled:~     active treatment is continued in the first group and the second group starts active CIBT~     treatment. The third week of study, treatment is stopped in both groups.~   "
254359|NCT00221676|"~     Besides the personal protection, influenza vaccination especially needs to prevent~     transmission of influenza between GPs and their patients. The question remains if the vaccine~     is adding substantial benefit to the natural acquired immunity of GPs. Doubts are raised if~     an inactivated vaccine, which elicit especially humoral immune response, can give enough~     protection against virus replication and subclinical influenza infections. Until now no~     effectiveness studies of influenza vaccination were performed among GPs. This study will~     assess the effectiveness of an inactivated influenza vaccine in GPs against clinical~     respiratory tract infections and more particular against influenza cases with influenza~     positive nose and throat swabs (diagnosed by RT-PCR).~   "
254360|NCT00221663|"~     Minimally-invasive operative techniques have been introduced in cardiac surgery. These~     techniques may have several advantages such as a decrease in post operative pain, lower~     morbidity and mortality, faster recovery, and a shorter hospital stay. However, these~     advantages have rarely been documented in the setting of a formal randomized controlled~     trial.~   "
254361|NCT00221650|"~     Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C.~     Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have~     previously been treated with a first line anti-HCV treatment. The purpose of the study is to~     evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with~     chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin.~     The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of~     ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained~     virological response, defined as an undetectable HCV RNA level 24 weeks after the end of~     anti-HCV treatment.~   "
254362|NCT00221637|"~     The purpose of this study is to determine whether valproate is effective and well tolerated~     in the treatment of neuropathic peripheral pain. The drug is administered by intravenous~     route followed by oral route during 4 weeks.~   "
254363|NCT00221624|"~     Response to a second-line anti-HCV treatment in non responder patients to a first-line dual~     therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be~     potentially effective to treat hepatitis C.~   "
254364|NCT00221611|"~     Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral~     palsy patients, by means of standardized and internationally accepted scales~   "
254365|NCT00221598|"~     Comparison between dialysate temperatures on haemodynamic stability and haemodialysis~     efficiency.~   "
254366|NCT00221585|"~     A prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients,~     consecutively referred during two years, with a first-episode psychosis of ICD-10, F-2 type.~     Patients were treated with: 1) ‘Supportive psychodynamic psychotherapy as a supplement to~     treatment as usual’, 2) an ‘Integrated, assertive, psychosocial and educational treatment~     programme’, and 3) ‘Treatment as usual’.~   "
254367|NCT00221572|"~     Measurement of bone density of Cystic Fibrosis patients with two techniques and correlation~     to serum bone parameters, use of steroids, lung function and nutritional status.~   "
254368|NCT00221559|"~     Serum Zn status of patients with cystic fibrosis at diagnosis and one year later, compared to~     a healthy control group~   "
254369|NCT00221546|"~     Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and~     health evolution of patients with cystic fibrosis~   "
254370|NCT00221533|"~     Relation between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial~     Stiffness in Renal Transplant Recipients~   "
254514|NCT00219661|"~     The purpose of this study is to determine whether drainage of subglottic secretions is~     effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's~     patients.~   "
254371|NCT00221520|"~     High-risk critically ill patients often require mechanical ventilation either to primarily~     support the respiratory function or when the ventilation is insufficient to maintain adequate~     gas exchanges as a result of other organ impairment. In order to tolerate this aggressive~     mechanical support, enhance patient synchrony with the ventilator, and relieve pain and~     anxiety, analgesia and sedation are provided. It is suggested that an inappropriate use of~     sedation and analgesia may prolong the duration of mechanical ventilation and increase the~     risk of specific adverse outcomes such as ventilator associated pneumonia. Despite the~     widespread use of sedation, little information is available concerning the effect of varying~     the level of sedation on patients' subsequent mental health. We designed a randomized~     controlled trial to investigate the efficacy of sedation with the goal of maintaining the~     patient cooperative and interactive compared to the administration of sedation with the goal~     of maintaining the patient sedated. The first goal will be achieved by a discontinuous~     injection of a sedative, while the second goal will be achieved by a continuous infusion of~     the same sedative. In both groups pain relief will be provided in the same fashion with equal~     endpoints on a pain scoring scale. Our primary aim is to investigate whether differences in~     the occurrence of post-traumatic stress disorders (PTSD), anxiety, and depression are related~     to the choice of sedation-analgesia strategies. Secondary endpoints include the length of ICU~     stay, as indicated by the time to discharge from the ICU, the time to separation from~     mechanical ventilation, the rates of pulmonary and extra-pulmonary complications, and~     hospital length of stay. These endpoints will be compared between the two groups.~   "
254372|NCT00221507|"~     The study hypothesis is that case management using patient navigators (promatoras in the~     Latino community) will increase infant immunization rates and use of well child care in an~     inner city population of low socioeconomic status.~   "
254373|NCT00221494|"~     Antidepressants are commonly prescribed and are effective for treating depression. However,~     they generally take 4-6 weeks for a therapeutic response. This study is evaluating whether~     simultaneous treatment with thyroid hormone or pindolol can decrease the response time~     (getting better faster) in patients who are starting SSRI treatment.~   "
254374|NCT00221481|"~     This study will evaluate how effective mood stabilizers are in the treatment of bipolar~     disorder with comorbid alcoholism~   "
254375|NCT00221468|"~     The purpose of this research study is to obtain preliminary data regarding the effectiveness,~     tolerability, and safety of quetiapine therapy for adolescents who have a mood disorder and~     have at least one parent with bipolar disorder (severe mood swings).~   "
254376|NCT00221455|"~     We seek to determine if patient data entry, data entered based alerts, and data review in a~     secure patient portal may provide a sustainable approach to improve diabetic outcomes in a~     cost effective manner. We plan to study the extent to which the portal can improve diabetic~     outcomes and quality of care. We recognize, however, that some patients will be more~     predisposed to adopting technology and some will be more predisposed to improving their~     compliance than others. Hence, we will also develop and test interventions that may improve~     adoption and compliance. The goals of the proposed study are: 1) to assess whether a web~     portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics~     of patients whose health behavior improves over the study period; 2b) to describe the~     characteristics of patients who adopt the web portal-based disease management technology; 3)~     to develop and test targeted interventions to increase the adoption of the web portal and~     improve patient health behavior; and 4) to monitor the ongoing costs associated with the web~     portal and patient healthcare resource utilization, and to monitor the incremental costs of~     the interventions designed to improve utilization of the technology and patient compliance~     with their diabetic regimens.~   "
254377|NCT00221442|"~     The specific aim of this study is to examine the efficacy and safety of zonisamide compared~     with placebo in outpatients with binge eating disorder associated with obesity.~   "
254378|NCT00221429|"~     This study will compare the efficacy of lithium, divalproex, and placebo in treating the~     acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and~     adolescents.~   "
254379|NCT00221416|"~     This is an investigator-initiated study whose primary aim is to determine the effectiveness~     of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current~     medications do not completely control those symptoms. Aripiprazole is a medication that has~     been approved by the United States Food and Drug Administration (FDA) for the treatment of~     Schizophrenia.~      A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to~     side effects with aripiprazole. The goal of this research is to identify individuals who~     metabolize aripiprazole more rapidly or slowly, which will potentially help the clinician~     make dosing adjustments and decrease the risk of adverse events.~   "
254380|NCT00221403|"~     The primary aim of this proposal is to conduct a preliminary controlled trial of valproate~     and risperidone in children ages 3-7 yr. with bipolar disorders. A secondary aim is to~     carefully characterize these subjects using clinical rating scales and develop pilot data on~     a very young cohort of children with bipolar disorders that can be used to support an~     application to NIMH for a prospective, longitudinal study that will provide important~     information about the course, medication response, neurobiology and outcome of these~     patients.~   "
254381|NCT00221390|"~     The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in~     improving movement among patients with chronic stroke.~   "
254382|NCT00221377|"~     This randomized controlled multi-centre trial in children from birth up to < 5 years of age~     aims to demonstrate equivalence as to the major outcome of post-extubation airway injury~     (stridor) comparing uncuffed tracheal tubes to current tracheal tubes with modern high volume~     - low pressure cuff combined with a cuff pressure release valve.~   "
254383|NCT00221364|"~     The WHO has initiated a program to eliminate blinding trachoma by the year 2020, in large~     part by mass oral azithromycin distributions. It is not clear how frequently or for how long~     these treatments are necessary. Here we assess the frequency and duration of treatment.~   "
254532|NCT00219427|"~     1. Purpose~           a. Examination on Efficacy of Retina Projection System~        2. Patients~           a. Low vision patients~        3. Methods~             1. Vision aids~                  -  Retina Projection System~                  -  Face-mounted video display as control~             2. Comparison of Reading Speeds with both vision aids~   "
254384|NCT00221351|"~     We aim to evaluate the impact of a CRP-guided management algorithm for adults with acute~     cough illness. More specifically, we will examine both process of care and clinical outcomes:~        1. Processes of care (i.e., chest x-rays ordered, antibiotic treatment, length-of-time in~          the ED). We hypothesize that CRP-guided management will be associated with a decrease in~          the antibiotic prescription for acute cough illness from 50 percent to 30 percent.~        2. Clinical outcomes (i.e., duration of illness, any return visit, return visit with a~          diagnosis of pneumonia, hospitalization, subsequent antibiotic use, satisfaction with~          care). We hypothesize that there will be no difference in the proportion of patients~          feeling back to normal within 2 weeks of their ED visit for acute cough illness (about~          60 percent, 95% confidence interval=50 to 70 percent).~   "
254385|NCT00221338|"~     This will be a double blind, placebo-controlled study of patients ≥65 years of age undergoing~     surgery of the spine, hips and knees replacement at the University of California, San~     Francisco (UCSF) Medical Center. Intraoperative anesthetic and postoperative pain management~     will be standardized. Patients will be randomized to receive either placebo or gabapentin~     preoperatively, and continued postoperatively until discharge. Intraoperative anesthetic and~     other postoperative pain management strategies will be standardized. Postoperative delirium~     will be measured using structured interviews. Cognitive function will be measured using a~     battery of neurocognitive tests pre- and post-operatively. Using an intention to treat~     strategy, we, the researchers at UCSF, will compare the amount of postoperative pain,~     narcotic requirements, and postoperative delirium and cognitive dysfunction between the two~     groups.~   "
254386|NCT00221325|"~     Rituximab is the first monoclonal antibody to receive approval in the treatment of cancer and~     has been proven to lead to extended survival when administered intravenously in the treatment~     of patients with systemic non-Hodgkin's lymphoma. We have previously demonstrated that a~     small fraction of Rituximab administered intravenously is able to cross the~     blood-brain-barrier into the brain.~      We will test the idea that the direct injection into the cerebrospinal fluid of Rituximab, a~     monoclonal antibody which attacks and kills lymphoma cells, is safe and when used in~     combination with methotrexate in patients with recurrent brain and intraocular lymphoma.~      We will also test the idea that the combination of rituximab plus methotrexate has activity~     and is effective in the treatment of recurrent brain and intraocular lymphoma.~   "
254387|NCT00221312|"~     This is a study to determine if Fosamax (alendronate), a medication approved by the Food and~     Drug Administration (FDA) for the prevention and treatment of osteoporosis in postmenopausal~     women, is effective in decreasing the rate of bone loss which often begins to increase in the~     three to five years preceding the menopause (perimenopausal transition).~      During the three to five years prior to the menopause, the rate of bone loss increases. One~     way that physicians treat this is with oral contraceptive medication. However, the incidence~     of complications from oral contraceptives after the age of 40 increases. Therefore, a~     non-hormonal means of preventing bone loss should be useful. Fosamax (alendronate) is in a~     class of compounds called bisphosphonates. This study is being done to determine whether~     Fosamax can be used to prevent the increased rate of bone loss during the perimenopausal~     transition.~   "
254388|NCT00221299|"~     The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH),~     either alone or with risedronate, will increase the thickness of the bones in the hip and~     spine in subjects with osteoporosis from chronic low dose steroid use. During the second~     year, the study will also look at whether taking risedronate will preserve the bone thickness~     created by one year of rhPTH 1-34 treatment.~   "
254389|NCT00221286|"~     The efficacy of pegylated interferons in the treatment of chronic hepatitis B has shown~     superior results to standard of care in patients only infected with hepatitis B. The efficacy~     of pegylated interferon for the treatment of chronic hepatitis B in HIV-coinfected patients~     is not known at present.~      The purpose of this study is to evaluate the efficacy of pegylated interferon in the~     treatment of chronic hepatitis B in HIV-infected individuals.~      Apart from evaluating the efficacy of pegylated interferon therapy in this setting as such,~     i.e. in patients without present or future need of highly active antiretroviral therapy~     (HAART) for HIV-infection, there is a second purpose of this study, to investigate whether~     combination treatment of HBV-infection may be superior to pegylated interferon therapy alone.~      Therefore patients without need of HAART are offered pegylated interferon alfa-2a over 48~     weeks. Patients who require HAART are offered emtricitabine / tenofovir DF containing HAART~     over 72 weeks PLUS pegylated interferon alfa-2a over 48 weeks vs. emtricitabine / tenofovir~     DF containing HAART over 72 weeks WITHOUT pegylated interferon-alfa-2a.~   "
254390|NCT00221273|"~     Compares tension of an ACL graft when using a commercial device vs. the tension of the graft~     applied by a physician during surgery.~   "
254391|NCT00221260|"~     To investigate if the use of perioperative neuraxial blockade reduces post-operative~     mortality and cardiorespiratory events compared to intraoperative general anesthesia AND~     postoperative IV narcotic analgesia. This is a feasibility study to determine if recruitment~     and execution of the protocol could be done in a timely manner in a much larger trial~   "
254402|NCT00221117|"~     Functional electrical stimulation is a process that uses low intensity electrical pulses~     generated by an electric stimulator to create muscle contractions. By contracting muscles in~     a specific sequence, one can generate various body functions such as grasping, walking, and~     standing.The study is designed to evaluate the effectiveness and long term benefits of~     applying functional electrical simulation during early rehabilitation to improve grasping~     function in persons who have suffered a spinal cord injury. By using functional electrical~     stimulation,these patients could potentially improve their grasping function.~   "
254403|NCT00221104|"~     Although hyperlipidemia is not always the risk factor of stroke, inhibition of~     3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke~     in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol~     lowering should be expected to attenuate inflammation and atherosclerosis. The present study~     hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with~     safety.~   "
254404|NCT00221091|"~     This study evaluates the efficacy of shunt operation for idiopathic normal pressure~     hydrocephalus, and determines the diagnostic value of noninvasive procedures commonly~     practiced in the clinic.~   "
254392|NCT00221247|"~     Background: Cerebral palsy (CP) is the most frequent cause of childhood disability in the US.~     Nevertheless, current standard of care for CP in the U.S. is to a large extent ineffective.~     The Chinese, on the other hand, claim to have an exceptionally high response rate with the~     administration of an integrated package of care that includes the combination of intense~     'conventional' therapies and acupuncture. Despite numerous anecdotal reports, this claim has~     not yet been tested in a rigorous scientific way. Objective: To determine the effectiveness~     of acupuncture when used as an adjunct to intense 'conventional' physical, occupational, and~     hydro- therapies to improve function and quality of life in children with spastic CP.~     Hypotheses: (1) Adjunctive acupuncture therapy will improve the gross and fine motor function~     and the health related quality of life of children with spastic CP more than intense~     'conventional' therapies alone. (2) The level of persistence of gross and fine motor function~     and health related quality of life achieved with adjunctive acupuncture administered in~     combination with intense 'conventional' therapies will be higher than those achieved with~     intense 'conventional' therapies alone. Design: A parallel, two-arm, prospective,~     evaluation-blind, pragmatic, non-inferiority, randomized controlled clinical trial (RCT).~     Setting: This international collaborative study will be conducted at two different~     localities: (1) At the Beijing Children's Hospital (BCH), where participants' recruitment,~     intervention therapies, videotape evaluation, and data collection will be done, and (2) At~     the University of Arizona, where scoring of the videotape evaluations and data analyses will~     be done, and from where logistic support will be provided to assure the scientific integrity~     of the study. Population: Approximately 100 children between the ages 1 and 6 years with~     spastic CP. Intervention: Concurrent administration of acupuncture with intense~     'conventional' therapies at the outset of the study vs. sequential administration of both~     components. Outcomes: 'Gross Motor Function', 'Fine Motor Function', 'Range of Motion',~     'Level of Motor Involvement', and 'Health-Related Quality of Life' measured at times~     0,4,8,12,24,and 36 weeks. Evaluation: Independent blinded evaluation with respect to the type~     of the intervention and the stage of the therapeutic schedule done in the U.S. based on~     videotapes filmed in China. Data management: Web-based data center and intersite-networking~     infrastructure. Data analyses: Intention to treat analysis supplemented by linear mixed~     effects models with nested grouping factors. Significance and future directions: If the~     hypotheses are confirmed the study would lay the groundwork for future research, and impact~     clinical practice and health care policy as related to CP therapy.~   "
254393|NCT00221234|"~     This project will assess the incremental and cumulative impact of three behavioural~     intervention strategies for the promotion of physical activity in the adult general~     population with Type 2 diabetes.~   "
254394|NCT00221221|"~     Over 30 studies have shown that exercise can improve physical fitness, reduce fatigue,~     increase functioning, and enhance overall quality of life (QoL) in breast cancer survivors~     both during and after treatments. Research has also shown, however, that breast cancer~     survivors experience a significant reduction in physical activity during treatments that is~     not recovered even years after treatments are completed. The objectives of this study are to~     examine the effects of two behavior change interventions (a step pedometer and printed~     materials) on physical activity, social cognitive variables, and QoL in a population-based~     sample of breast cancer survivors. Approximately 300 breast cancer survivors living in~     Northern Alberta will be randomized to one of four groups: (1) an exercise recommendation~     only group (viewed as the current standard of care), (2) an exercise recommendation plus~     pedometer group, (3) an exercise recommendation plus printed materials group, and (4) an~     exercise recommendation plus pedometer and printed materials group. Our primary hypothesis is~     that participants receiving the combined pedometer and printed materials intervention will~     report the greatest change in physical activity. Our secondary hypotheses are that these~     interventions will also result in improved QoL and more positive social cognitive beliefs~     about exercise in breast cancer survivors. Given the geographic dispersion of our population,~     finding practical and sustainable interventions that employ distance medicine-based~     approaches may be ideal for promoting healthy activity patterns in breast cancer survivors in~     Northern Alberta.~   "
254395|NCT00221208|"~     This study will investigate the biological and psychosocial benefits of a home-based~     resistance-training program for sedentary, obese adults living with type 2 diabetes.~   "
254396|NCT00221195|"~     The objective of this study is to assess whether prophylactic therapy with an activated~     prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number~     of bleeds in patients with hemophilia and persistent high responding inhibitors.~   "
254397|NCT00221182|"~     The purpose of this study is to determine if stem cell therapy with your own cells~     (autologous cells) delivered with a catheter to regions of the heart with poor blood flow~     will be safe and if it will relieve your chest pain, increase the blood flow, and/or improve~     the cardiac contractility (function) by regenerating blood vessels in your heart.~   "
254398|NCT00221169|"~     Radiation therapy is an important part of the treatment for lung cancer when treatment intent~     is for cure. Radiation is a local modality of treatment, that is, it only treats the area~     that the radiation can target. Therefore it is critical to be able to visualize all the areas~     of tumor involvement. With current imaging tests such as computed tomography scans (CT), the~     scans may not be sensitive enough to detect all areas of cancer involvement but with newer~     imaging tests, such as positron emission tomography (PET), the investigators may be able to~     better target all the tumor that the CT scan may miss. There are two clinical trials being~     conducted by the Ontario Clinical Oncology Group (OCOG)looking at PET in lung cancer. This~     proposal is a companion study to the OCOG PET lung trials. In brief, this study will evaluate~     the ability of CT alone versus combined PET CT imaging to determine the size of the tumor (or~     gross tumor volume) along with the tiny extensions of cancer cells (or microscopic~     extension). The gross tumor volume and its extension as determined by CT or PET CT will then~     be compared to measurements made on the surgically removed tumor. Treatment with radiation~     therapy must include all the gross tumor and its extension in order to be successful for~     cure. If the radiation treatment does not treat all the identified tumor then the chance for~     cure is lost. There have only been two previous reports of the ability of CT to determine the~     gross tumor volume and its extension. There are no similar reports using PET CT. This study~     will be the first of its kind to evaluate how accurate PET CT can be in detecting the gross~     tumor and its microscopic extension using the surgically removed tumor measurements as the~     gold standard. If PET CT is able to more accurately determine the tumor volume including its~     microscopic extension, then this will help oncologists to better treat lung cancer using more~     accurate radiation treatment volumes.~   "
254399|NCT00221156|"~     The purpose of this study is to determine whether the intervention for newly diagnosed~     abnormal glucose tolerance after coronary stenting will improve the long-term clinical~     outcome.~   "
254400|NCT00221143|"~     The purpose of this study is to determine if stem cell therapy with one's own cells~     (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to~     poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or~     cure the leg wound.~   "
254401|NCT00221130|"~     Adult periodontitis is a chronic infective disease affecting the periodontium. Periodontitis~     induce the destruction of attachment apparatus of teeth, resulting in periodontal pocket~     formation and teeth loss. This study will test the safety and efficacy of alveolous bone~     reproduction by the transplantation of mixture named periodontium injectable gel for the~     adult periodontitis patients. Injectable gel is the mixture of ex-vivo cultured mesenchymal~     stem stem cells, ex-vivo cultured osteoblast-like cells differentiated from mesenchymal stem~     cells and scaffold (include, platelet rich plasma, human thrombin and calcium chloride).~   "
254417|NCT00220922|"~     This study is designed to compare injection site reactions with or without the use of alcohol~     wipes prior to performing the patients' daily Copaxone® injection.~   "
254533|NCT00219414|"~     The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn~     Apheresis System to treat the signs and symptoms of ulcerative colitis.~   "
254405|NCT00221078|"~     Functional electrical stimulation (FES) is a process that uses low intensity electrical~     pulses generated by an electric stimulator to create muscle contractions. By contracting~     muscles in a specific sequence, one can generate various body functions such as grasping,~     walking, and standing. Final goal of the study is to evaluate if FES training when applied~     early during rehabilitation will help stroke patients to use their hands more effectively~     after discharge from a rehabilitation facility, compared to those patients who have not~     received FES training.~   "
254406|NCT00221065|"~      Obstructive sleep apnea(OSA) is a sleep breathing disorder. When a person with OSA tries~     to sleep the back of the throat closes and blocks the flow of air into lungs.When this~     happens, a person's sleep is disrupted, causing minor awakenings(which the individual may not~     recognize). This occurs many times throughout the night, causing poor sleep quality,excessive~     daytime sleepiness, poor concentration, and sometimes depression.It is possible that poor~     outcomes observed in stroke patients with OSA result from these neurocognitive phenomena,~     presumably by reducing effective participation in rehabilitation activities.OSA is treated~     with nasal continuous positive airway pressure(CPAP).CPAP therapy keeps the back of the~     throat open so that airflow is never blocked.The study is designed to investigate whether~     treatment of OSA with CPAP improves the results of rehabilitation.~   "
254407|NCT00221052|"~     Overweight increases the risk to develop chronic diseases including type-2 diabetes and~     cardiovascular disease. The low-grade inflammatory status often seen in overweight subjects~     is thought to play an important role in disease development.~      The purpose of this study is to determine the role of inflammation on glucose metabolism and~     insulin resistance. In this study the effect of the anti-inflammatory treatment diclofenac on~     markers of inflammation and on parameters of glucose metabolism will be studied.~   "
254408|NCT00221039|"~     The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of~     methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical~     effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.~   "
254409|NCT00221026|"~     his study will explore the safety and activity of ECP treatment with UVADEX in inducing a~     clinical response (i.e., a CDAI decrease greater than or equal to 100 from baseline and/or a~     CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or~     equal to 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or~     anti-TNF agents. This study will also assess response to continued treatment during a 12-week~     Extension Period in patients who have a clinical response at Week 12 of the Treatment Period~     and elect to participate in the Extension Period.~   "
254410|NCT00221013|"~     This study seeks to determine if increasing the dose of continuous renal replacement therapy~     (CRRT) reduces 90-day all cause mortality in Intensive Care Unit (ICU) patients with severe~     acute renal failure (ARF).~   "
254411|NCT00221000|"~     Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disorder that can cause~     substantial pain and joint tenderness, significant joint damage, and serious disability. The~     treatment goals are minimization of the signs and symptoms of the disease, and the reduction~     of irreversible joint damage.~      As the understanding of the pathophysiological mechanisms underlying RA is elucidated, the~     opportunity to target specific inflammatory processes with new therapies has improved.~     Rheumatoid arthritis is a T cell-mediated autoimmune disease and there are various therapies,~     including newer experimental therapies, which target either the activation of T cells or the~     neutralization of their effector mechanisms. These newer therapies have shown benefit in~     human and animal models of RA. Extracorporeal photoimmune therapy (ECP) has been shown to be~     safe and effective in the palliative treatment of the skin manifestations of cutaneous T cell~     lymphoma. Experimental studies have also demonstrated activity of ECP treatment in several T~     cell mediated diseases including graft versus-host disease, rejection after organ~     transplantation, and selected autoimmune diseases.~      This study will evaluate a cell-based therapy (ECP) in patients who have an inadequate~     response to disease-modifying antirheumatic drugs (DMARDs) and biological agents to determine~     if ECP treatment can reduce the signs and symptoms of RA in this refractory patient~     population.~   "
254412|NCT00220987|"~     The primary aim of the study is to compare the effects of the two blood glucose targets on 90~     day all-cause mortality in Intensive Care patients who are predicted on admission to stay in~     the ICU for at least one full calendar day. The hypothesis is that there is little difference~     in the relative risk of death between patients assigned a glucose range of 4.5 - 6.0 mmol/L,~     and those assigned a glucose range of less than 10.0 mmol/L with insulin being infused if~     blood glucose exceeds 10.0 mmol/L, and adjusted when needed to maintain blood glucose of 8.0~     - 10.0 mmol/L.~   "
254413|NCT00220974|"~     The purpose of this trial is to find out if a special website might help people discover if~     they have high cholesterol and then enable them to manage their cholesterol more~     appropriately. The primary aim of this trial is to determine the effects on consumers' use of~     cholesterol lowering therapy of an online service that provides automated, individually~     tailored, advice about eligibility for cholesterol lowering treatment. The primary null~     hypothesis being tested is that the service will result in no change in the use of~     cholesterol lowering treatments by consumers that use the service.~      The secondary aim of the trial is to see if it is possible to improve the cholesterol~     management of the friends or relatives of consumers that use the I-CAT service. The~     corresponding secondary null hypothesis being tested is that the I-CAT service will result in~     no change in the use of cholesterol lowering treatments by the friends or relatives of the~     consumers that use the service.~   "
254414|NCT00220961|"~     The purpose of this study is to examine whether pioglitazone versus placebo can reduce the~     conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus~   "
254415|NCT00220948|"~     Hypothesis:~      Myoelectric patterns observed from the CERSR array during standardized testing are sensitive~     in identifying healthy subjects from patients with internal disc derangement and a positive~     discogram. A positive CT discogram is defined as one following the Dallas discogram protocol~     with abnormal disc morphology and reproduction of symptoms~   "
254416|NCT00220935|"~     Hypothesis – This study is designed to evaluate the results of using the Orthotrac Pneumatic~     Vest versus an EZ form brace in patients with radiating leg pain from disc bulge / protrusion~     / herniation. Specifically, our hypothesis is that patients given the Orthotrac Pneumatic~     Vest (OPV) will have greater pain relief and increased self-reported functionality and fewer~     progressions to surgery than those using the EZ form brace.~   "
254418|NCT00220909|"~     The primary objective of this study is to determine whether lansoprazole, administered~     intravenously, can protect patients undergoing cardiac surgery from the development of and/or~     progression of previously undetected acid/peptic disorders (erosive esophagitis, gastric~     ulcer, duodenal ulcer, diffuse gastritis, duodenitis) as measured by the Lanza score and LA~     classification for esophageal injury.~      The secondary objectives of this study are:~        1. To determine if intravenous lansoprazole protects against the development of clinically~          important gastrointestinal bleeding in this population (overt bleeding or requiring~          blood transfusion).~        2. To determine if intravenous lansoprazole maintains the intragastric pH above that for~          placebo throughout the study period.~   "
254419|NCT00220896|"~     Patients undergoing hip or knee joint replacement at the age of 70 years or above who are~     cognitively unimpaired will receive donepezil or matching placebo before (over 5-7 days),~     during and after (over 7 days) surgery. The incidence of delirium will be monitored at 3~     days, 7 days, and 49 days following surgery. We hypothesize that the incidence of delirium~     can be lowered from 20 per cent to 10 per cent by the intervention.~   "
254420|NCT00220883|"~     The primary objective of this study is to determine whether EGG readings obtained from both~     normal subjects and dyspeptic patients are reproducible from one EGG recording to another on~     a different day.~      The secondary objective of this study is to determine whether the EGG readings are analyzed~     and diagnosed consistently when reviewed and compared by multiple blinded readers when the~     same tracing is reviewed.~   "
254421|NCT00220870|"~     The impact of a decision aid for inpatients with schizophrenia on perceived involvement and~     compliance is studied in comparison with routine care.~   "
254422|NCT00220857|"~     To determine the effectiveness of rabeprazole in preventing or decreasing acute~     gastroduodenal injury caused by therapeutic doses of aspirin in a placebo-controlled,~     randomized, double-blind parallel group study.~   "
254423|NCT00220844|"~     The purpose of this study is to determine the effects of two tricyclic antidepressant agents~     (TCAs), amitriptyline and desipramine, on gastric emptying and gastric accommodation using a~     newly developed scintigraphic test that simultaneously measures both gastric emptying and~     gastric volume (accommodation). These two tricyclic antidepressant agents are commonly used~     at low doses to treat patients with refractory functional dyspepsia.~   "
254424|NCT00220831|"~     The purpose of this study is to determine whether Vitamin E treatment to Diabetic patients,~     who carry the Haptoglobin 2-2 Phenotype, prevents cardiovascular complications such as acute~     MI and Stroke.~   "
254425|NCT00220818|"~     The purpose of this study is to understand how quickly lansoprazole, once daily (QD),~     improves feeding in premature babies or babies less than 28 days of age.~   "
254426|NCT00220805|"~     This study will evaluate visual improvement in patients treated with Immune Globulin~     Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) or placebo who have~     Age-Related Macular Degeneration (AMD) with occult Choroidal Neovascularization (CNV).~   "
254427|NCT00220792|"~     The purpose of this study is to determine whether women with primary breast cancer who were~     randomly assigned to receive a brief group therapy would show a greater reduction in mood~     disturbance over time compared to those randomized to the control condition. We also~     hypothesized that women who were highly distressed at baseline would show the greatest~     benefit from participating in a support group, and that therapists with more training and~     experience would be most effective in reducing distress.~   "
254428|NCT00220779|"~     The trial will study 2 doses of Immune Globulin Intravenous (Human), 10%~     Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year~     treatment period.~   "
254429|NCT00220766|"~     The objective of this study is to determine if the safety and tolerability of Immune Globulin~     Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at~     two different infusion rates. The primary objective is to compare the incidence and severity~     of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14~     mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.~   "
254430|NCT00220753|"~     The purpose is to find out if Icleen IQAir, HEPA-filter air cleaners with high capacity and~     pre-set speed functions, have a beneficial effect on patients with asthma and allergy to~     dogs.~      Air cleaners will be installed in the bedrooms and living rooms in the homes of children and~     adolescents aged 8-17 years at the study entry, with allergy to dogs, but not to house dust~     mites.~      The investigators will look upon the significance of this study, and of a previous study with~     a similar design and the same main parameters to find out if this trial supports the results~     of the first trial by the same project leader, or makes it likely that the seemingly~     beneficial effects of the first study occurred by chance.~      Main parameters:~        -  hyperventilation cold air challenge test~      Supportive parameters:~        -  serum ECP~        -  symptom scores~      The trial will be a parallel, double blind placebo controlled one.~   "
254431|NCT00220740|"~     The intent of this study is to demonstrate the efficacy and safety of Immune Globulin~     Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously~     diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur~     every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and~     Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and~     month 6 will receive the alternate study drug for an additional 6 months.~   "
254432|NCT00220727|"~     The objective of this study is to determine if the safety and tolerability of Immune Globulin~     Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at~     two different infusion rates.~   "
254467|NCT00220272|"~     -  The primary objective is to study the effect of SR57667B at the dose of 4 mg/d on~          progression of dopaminergic nigro-striatal lesions assessed by 18F-Dopa PET imaging.~        -  Secondary objectives are to assess the effect of SR57667B on symptomatic decline in~          patients with early PD, to assess the safety/tolerability of SR57667B in patients with~          early PD and to document plasma concentrations of SR57667 in patients with early PD.~   "
254553|NCT00219141|"~     To compare the efficacy and safety of aliskiren in combination with losartan compared to~     losartan on the regression of the increased size of the left ventricle in overweight patients~     with high blood pressure.~   "
254433|NCT00220714|"~     Many patients who have recently received a diagnosis of schizophrenia (e.g., first-episode~     schizophrenia) respond very well to their antipsychotic medication when they are acutely~     ill. Once they are more stable, research has shown that first-episode patients need to remain~     on their antipsychotic medication. Follow-up studies show that stopping medication~     prematurely is the most common cause of relapse and readmission. It is important to have new~     ways to help patients stay stable in the community in order for them to continue on with~     their rehabilitation and recovery process.~      Over the last decade, new antipsychotic medications have been developed that are more~     effective and have fewer side effects than older antipsychotics. The new medicines are often~     called atypical, and were only available by pill or capsule for long-term treatment. Most~     recently, one of the atypical medications - risperidone - became available as a long-acting~     injection that can be given once every 2 weeks.~      The hypothesis of this study is that patients recovering from an acute episode and who then~     go on to receive a long-acting version of atypical antipsychotic medication (long-acting~     risperidone microspheres) will stay on their medications for longer than those who take their~     atypical medication (any available first-line atypical) in the oral (pill) form.~   "
254434|NCT00220701|"~     This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of~     dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.~      It is hypothesized that Escitalopram will be superior to placebo in improving depression, as~     well as psychosocial, temperamental, and cognitive functioning.~   "
254435|NCT00220688|"~     Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from~     terminal cancer who are troubled by nausea and vomiting.~   "
254436|NCT00220675|"~     To determine whether erythropoietin, steroids and radiotherapy is safe and feasible to~     administer to patients with malignant spinal cord compression.~   "
254437|NCT00220662|"~     This research examines the efficacy of a 5-session individual psychotherapy intervention~     designed to enhance readiness and motivation for change in individuals with anorexia nervosa,~     bulimia nervosa, and eating disorder not otherwise specified.~      It is hypothesized that individuals randomly assigned to receive Readiness and Motivation~     Therapy (RMT) will have higher readiness and motivation scores and improved eating disorder~     and psychiatric symptomatology following the intervention than individuals assigned to a~     no-treatment control condition.~   "
254438|NCT00220649|"~     The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting~     toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan,~     5-fluorouracil/leucovorin and gemcitabine in patients with metastatic solid tumors or~     adenocarcinoma of the pancreas.~   "
254439|NCT00220636|"~     This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical~     antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI)~     antidepressant treatment for depressed outpatients who are not responding fully to SSRI~     treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of~     treatment with Aripiprazole and SSRI medication.~   "
254440|NCT00220623|"~     Major Depressive Disorder affects approximately 16% of the adult population over the~     lifetime. Controlled studies indicate that short-term antidepressive medications or~     psychotherapy produce full remission in only about 46% of patients. Furthermore, about 80% of~     patients will continue to have subsequent recurrences after remission of the first episode,~     with each episode increasing the probability of future recurrences. This pilot study will~     examine whether antidepressive medications plus one of three commonly available types of~     psychotherapy used in the short-term treatment of depression can protect against the~     recurrence of depression if active treatment is extended to 18-months duration. Results will~     aid designing a more complete study.~      Adults with an acute episode of major depressive disorder with at least one prior episode~     will be randomized to Antidepressive medications (ADM) plus 18-months of either~     Cognitive-behavioral therapy (CBT) or Dynamic psychotherapy (DYN), or to a standard control~     therapy, Supportive Clinical Management (SUP-CM). We will determine whether a higher~     percentage of those receiving either CBT or DYN remain well after three years of follow-up,~     compared to those receiving the standard control treatment. We will also examine the~     reduction in psychological risk factors as well as potential economic benefits of the three~     approaches.~   "
254441|NCT00220610|"~     Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20~     minutes per session.During the rTMS session, the coil was centered flat over the right~     parietal cortex.~      We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure~     the depression with different rating scales.~      We hypothesized that rTMS has a positive effect in the treatment of depression~   "
254442|NCT00220597|"~     This study will evaluate the effectiveness of trauma-focused group therapy for reducing~     HIV-risk behavior and revictimization among adult women survivors of childhood sexual abuse~     (CSA).~   "
254443|NCT00220584|"~     Fragile X syndrome is the most common known inherited cause of neurodevelopmental disability.~     Functional magnetic resonance imaging (fMRI) studies from our laboratory indicate that~     specific brain regions using the neurochemical, acetylcholine, show significantly reduced~     activation during learning. Since donepezil is a medication that enhances acetylcholine~     function in the brain, the purpose of this study is to determine if donepezil has any~     beneficial effect on behavior or cognition in subjects with fragile X syndrome.~   "
254444|NCT00220571|"~     The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted~     to hospitals with no PTCA facilities is to compare the effects on clinical outcome and~     cost-effectiveness of two reperfusion strategies:~        -  Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of~          lack of reperfusion~        -  Elective referral for “facilitated” PTCA after early administration of Abciximab and~          half dose of Reteplase~   "
254445|NCT00220558|"~     The objective of this study is to compare the Cypher Select-TM Sirolimus Eluting Stent (SES)~     with the SONIC-TM Bare Metal Stent (BMS) in the treatment of Chronic Total Occlusion lesions~     (CTO). The primary hypothesis is that, at 8-month follow-up, the minimal luminal diameter~     (MLD) of the coronary segment treated with stent implantation in CTO lesions is significantly~     larger with the use of SES compared to BMS. The treated segment is defined as the segment~     covered by the stent(s) plus 5 mm proximally and distally to the stent(s).~   "
254446|NCT00220545|"~     Laparoscopic ovarian diathermy (LOD) is currently offered to infertile women with polycystic~     ovarian syndrome (PCOS) who fail to conceive on clomiphene citrate (CC). However, using LOD~     before CC may result in a better reproductive outcome since LOD may reduce risks associated~     with CC such as miscarriages and multiple pregnancies. The aim of the study is to evaluate~     the effectiveness of LOD and its potential value in improving the success rates in infertile~     women with PCOS. This study will recruit 72 women with PCOS suffering from infertility due to~     lack of ovulation from the infertility clinic. After initial assessment, patients will be~     given explanation about the study and will receive an information leaflet. They will then be~     randomized into two groups: Group1 (36 patients) will receive CC as per infertility clinic~     protocol to induce ovulation for up to 6 months. Group 2 (36 patients) will undergo~     laparoscopic ovarian diathermy under general anaesthetic. Blood samples will be taken from~     both groups before any treatment, shortly after treatment and at 3 and 6 months after~     treatment to measure various hormones. Patients will be contacted every month after treatment~     for follow up. The reproductive outcomes particularly the pregnancy and livebirth rates will~     be compared between the two groups.~   "
254447|NCT00220532|"~     This is a randomised double-blind placebo-controlled trial to see whether giving a low dose~     of the vitamins folic acid and riboflavin is beneficial to women who have very low grade~     abnormalities of the cervical cells.~   "
254448|NCT00220519|"~     Critical illness and the therapies that accompany it are associated with a disruption in the~     ecological equilibrium of the GI tract that can ultimately lead to infection. Lactobacillus~     GG, a probiotic, replenishes the healthy flora of the intestinal tract and may decrease the~     risk of diarrhea and infection during critical illness. However, little is known about the~     impact of probiotics following a burn injury and the mechanisms behind the proposed benefits.~     The hypothesis of this research is that Lactobacillus GG decreases the incidence of diarrhea~     and infection in burned children receiving antibiotic therapy. The specific aim of this~     research is to determine the impact of Lactobacillus GG on the incidence of diarrhea and~     infection among burned children (>20% TBSA) receiving antibiotic therapy.~   "
254449|NCT00220506|"~     To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS~     Patients~   "
254450|NCT00220493|"~     Scientific background:~      Growing awareness and accumulating data regarding the cognitive impairment and its~     progression in multiple sclerosis (MS) patients has received an important place in~     neurological research in the last decade.~   "
254451|NCT00220480|"~     The primary objective of this multicenter study is to evaluate the efficacy of escitalopram~     in treatment resistant depression (TRD), assessed by 2 consecutive failed antidepressant~     treatments from different classes. The last treatment received is a 6 week prospective trial~     with venlafaxine.~   "
254452|NCT00220467|"~     The specific aims for the study will be to determine if aerobic exercise enhances cognition~     for older adults who are at greater risk for developing Alzheimer's disease, and to evaluate~     whether change in insulin sensitivity predicts cognitive performance for subjects randomized~     to the aerobic exercise group. Sedentary older adults diagnosed with mild cognitive~     impairment will participate in a 6-month supervised protocol of either aerobic exercise or~     stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and~     6. Before and after the 6-month intervention, insulin sensitivity, maximum aerobic capacity,~     and body fat composition and distribution (via CT scan) will be assessed for all subjects.~     The results of this study may provide support for a relatively simple and inexpensive~     treatment strategy that specifically targets many of the health factors that directly~     influence risk of cognitive decline for older adults.~   "
254453|NCT00220454|"~     The study tests the hypothesis that estradiol administration exacerbates the effects of the~     stress hormone cortisol on cognition and mood for postmenopausal women. This randomized,~     placebo-controlled, double-blind study was designed to examine the effects of an eight-week~     trial of transdermal estradiol replacement therapy (0.10 mg/day) in combination with 4 days~     of oral hydrocortisone (90 mg/day in 3 daily doses of 30 mg per dose) in the last week of~     hormone therapy on cognition and mood in healthy postmenopausal women. Forty cognitively~     healthy postmenopausal women were randomized to receive either placebo or estradiol skin~     patches for 8 weeks. In the middle of the 7th week (day 57), subjects in each group were~     again randomized to receive either a placebo tablet or an oral hydrocortisone tablet 3x/day~     for 4 days. Memory testing and blood collection occurred at baseline, at week 4, and again at~     week 8.~   "
254454|NCT00220441|"~     The specific aims for the study will be to determine if aerobic exercise enhances cognition~     for older adults who are at risk for developing type II diabetes mellitus (T2DM), and to~     evaluate whether change in insulin sensitivity predicts cognitive performance for subjects~     randomized to the aerobic exercise group. Sedentary older adults diagnosed with impaired~     glucose tolerance using an oral glucose tolerance test will participate in a 6-month~     supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood~     collection will occur at baseline, and months 3 and 6. Before and after the 6-month~     intervention, insulin sensitivity, maximum aerobic capacity, and body fat composition and~     distribution (via CT scan) will be assessed for all subjects. The results of this study may~     provide support for a relatively simple and inexpensive treatment strategy that specifically~     targets many of the health factors that directly influence risk of cognitive decline~     associated with T2DM for older adults.~   "
254455|NCT00220428|"~     The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.~   "
254456|NCT00220415|"~     Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with~     partial seizures and are taking up to 3 medications for this medical condition will take part~     in this research study at approximately 80 different locations in Australia and Europe.~      The purpose of this study is to evaluate the effectiveness, safety and tolerability of~     consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months.~      Each patient who qualifies and chooses to participate in the study will receive placebo~     (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target dose~     of 200mg/day or 400mg/day. The target dose or placebo will be maintained for 12 weeks.~      The study clinic visits will include a medical history and physical exam, ECG, blood and~     urine sample collection, and completion of a seizure diary.~      Patients who complete the study may enroll in an extension trial and receive active study~     drug.~   "
254457|NCT00220402|"~     This trial will provide long-term data on safety, satisfaction and maintenance on therapy of~     fesoterodine (SPM 907) in subjects with overactive bladder syndrome.~      Subjects completing the 12 week treatment period of SP583 had the opportunity to participate~     if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the~     dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which could be~     followed on an annual basis.~      Two primary efficacy variables will be assessed, which are observation and assessment of~     adverse events and duration on therapy.~      Secondary efficacy parameters included various parameters derived from micturition diaries~     and the evaluation of Quality of Life questionnaires (KHQ and ICIQ-SF).~      The most important safety variables included the assessment of adverse events, laboratory~     parameters, changes in ECG, physical exams and measurement of residual urine.~   "
254458|NCT00220389|"~     This extension trial of SP668 consists of two phases: double-blind treatment and open-label~     extension. The trial provides subjects the option of long-term treatment with sustained~     release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and~     efficacy.~      Double-Blind: Subjects remained on either fesoterodine 4mg, 8mg or 12mg depending on their~     dose assignment in SP668. Previous SP668 placebo subjects received fesoterodine 4mg.~      Open-Label: Subjects received fesoterodine 8mg with a one time option to reduce the dose to~     4mg and a one time option to increase again to 8mg.~      The primary variables focus on long-term safety and tolerability and include the observation~     and assessment of adverse events, residual urinary volumes, laboratory parameters, changes in~     ECG, physical and urological examinations and subject's assessment of treatment tolerance.~      Secondary efficacy variables include various parameters derived from micturition diaries,~     count of subjects and their dose choice throughout the trial and subject's assessment of~     treatment efficacy.~   "
254459|NCT00220376|"~     This trial will provide long-term data on safety, satisfaction and maintenance on therapy of~     fesoterodine (SPM 907) in subjects with overactive bladder syndrome.~      Subjects completing the 12 week treatment period of SP584 had the opportunity to participate~     if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the~     dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which can be~     followed on an annual basis.~      The primary variables are long-term safety and tolerability, measured by observation and~     assessment of adverse events and duration on therapy. Further safety variables include the~     assessment of laboratory parameters, changes in ECG, physical exams and measurement of~     residual urine.~      Secondary efficacy variables included various parameters derived from micturition diaries and~     the evaluation of Quality of Life questionnaires~   "
254460|NCT00220363|"~     The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2~     week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving~     either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or~     placebo during the Double-Blind Treatment Period.~      Two primary efficacy variables will be assessed for submission in the United States: change~     in the average number of micturitions (frequency) per 24 hours and the change in the average~     number of urge incontinence episodes per 24 hours. For the submissions in the European Union,~     the first primary variable will be the change in the average number of micturitions~     (frequency) per 24 hours and the co-primary variable is the treatment response, based on a~     treatment benefit scale. All continuous variables will be measured as changes from baseline~     to value after 12 weeks of treatment.~      The most important safety variables included the assessment of adverse events, laboratory~     parameters, changes in ECG, physical exams and measurement of residual urine.~   "
254461|NCT00220350|"~     This study compared cognitive-behavioral psychotherapy with leuprolide acetate (LA) to~     cognitive-behavioral psychotherapy with saline injections for 12 months. Five white male~     pedophiles (M age, 50 years; range, 36-58) volunteered for a two-year study. LA was~     administered by Depo injection (7 mg initially, then 22.5 mg every 3 mos) for 12 months,~     followed by saline placebo. Effects of LA on testosterone levels, sexual interest preference~     by visual reaction time (Abel Assessment), penile tumescence (Monarch PPG), as well strong~     urges and masturbatory frequency to children (polygraph), were measured every three months.~     Subjects were treated with weekly cognitive-behavioral psychotherapy. On LA, testosterone~     decreased to castrate levels. Because of the suppression of testosterone, physiologic arousal~     response as measured by penile plethysmography (penile tumescence) was significantly~     suppressed compared with baseline. However, sufficient response remained to detect pedophilic~     interest. This pedophilic interest was also detected by visual reaction times. All subjects~     self-reported a decrease in strong pedophilic urges and masturbation. When asked about having~     pedophilic urges and masturbating to thoughts of children, polygraph responses indicated~     subjects were not deceptive when they reported decreases. On placebo, testosterone and~     physiologic arousal eventually rose to baseline levels. At baseline and on placebo, subjects~     were consistently deceptive regarding increased pedophilic urges and masturbatory frequency~     as noted by polygraph. Interest preference, as measured by Abel Assessment and Monarch PPG,~     was generally unchanged throughout the study. Cognitive-behavioral psychotherapy augmented~     with LA significantly reduced pedophilic fantasies, urges, and masturbation, but did not~     change pedophilic interest during one year of therapy. Deceptive responses by polygraph~     suggested that self-report was unreliable. Follow-up utilizing objective measures is~     essential for monitoring efficacy of treatment in pedophilia. Our study supports the~     supposition that modification of pedophilic behavior is possible. LA may augment~     cognitive-behavioral psychotherapy and help break the sequence leading to a reoffense.~   "
254462|NCT00220337|"~     The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a~     longer period of time and whether it continues to work well to treat pain.~      Subjects will receive lacosamide at a dose that will be individually determined to be the one~     that provides most pain relief with the least side effects. The maximum dose will be~     600mg/day. Subjects may participate in this trial until October 2007. This time may be~     extended to allow them to participate until lacosamide is commercially available.~      If a subject meet the requirements for the study at Visit 1 and after a two weeks phase~     without trial medication, s/he enters a Titration Phase to determine the personal optimal~     dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will~     be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks~     thereafter.~   "
254463|NCT00220324|"~     The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and~     safety of SH D00342A. Subjects participating in the study will be treated with an oral~     contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.~   "
254464|NCT00220311|"~     The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate~     administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in~     untreated chronic lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.~   "
254465|NCT00220298|"~     This study will evaluate the preparation of testosterone undecanoate under conditions which~     resemble real-life situations.~   "
254466|NCT00220285|"~     The purpose of this study is to investigate the antitumor effect and safety of the product~     for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.~   "
254468|NCT00220259|"~     The overall aim of this study is to find out whether taking regular inhaled steroids (eg~     Pulmicort, Flixotide, Becotide, Becloforte) is good for the lungs of children and adults with~     cystic fibrosis (CF).~      Some patients are put on inhaled steroids because they are wheezy despite taking regular~     bronchodilators (inhaled medicines that help open up the airways eg Ventolin, Bricanyl).~     Occasionally young children are put on them when they wheeze with colds, and have simply~     remained on them ever since. However many CF patients have been put onto inhaled steroids~     because their doctors thought it might reduce the inflammation in the lungs and help improve~     lung function. This inflammation (which is swelling of the lining of the airways) is known to~     be important in CF and results from recurrent chest infections.~      Although it is believed, in theory, that inhaled steroids should be useful for most CF~     patients, we are not sure how well they work in CF and it has not yet been possible to prove~     this with standard studies. This would normally involve starting inhaled steroids in patients~     who have not been taking them. We have therefore taken a different approach, namely to~     withdraw them from some patients who have been on them for a long time, to see if there is~     any effect of stopping them.~      It is important that we answer this question, as we do not want CF patients taking medicines~     that may be unnecessary. CF patients already have to take many oral and inhaled medicines and~     if we can cut down this burden, it would be helpful for everyone. Of course, we may find that~     patients do need these medicines but at least we will then be certain that it is for a good~     reason.~      The main hypothesis is that withdrawing inhaled steroids is not associated with an earlier~     onset of acute chest exacerbations.~   "
254469|NCT00220246|"~     Two major genetic pathways leading to colorectal carcinoma can well be distinguished; the~     'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and~     the 'mutator pathway', which is characterized by microsatellite instability. The purpose of~     this study is to explore a third putative pathway; microsatellite and chromosome stable~     colorectal cancer where an alternative cancer-causative mechanism might play a role.~   "
254470|NCT00220233|"~     This study is to test the efficacy and safety of the combination of olmesartan and amlodipine~     in hypertensive patients whose blood pressure is not adequately controlled with amlodipine~     alone~   "
254471|NCT00220220|"~     Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive~     patients whose blood pressure is not adequately controlled with olmesartan alone.~   "
254472|NCT00220207|"~     This grant supports a 12-month randomized controlled trial comparing usual care versus~     collaborative disease management over the Internet among disadvantaged African-Americans with~     Type 2 diabetes. The project aims to: (1) determine the effect of case-managed, Web-based~     diabetes care on glycemic control, health care utilization, self-efficacy, and patient~     satisfaction; and (2) qualitatively identify enablers of the successful use of computers, the~     Internet, and e-Health applications by disadvantaged patients.~   "
254473|NCT00220194|"~     Comparing the effect of switching from Lupron and Zoladex to Eligard. PSA and Testosterone~     levels are measured at set intervals to determine if Eligard is equal or better then Lupron~     or Zoladex in advanced Prostate Cancer patients.~   "
254474|NCT00220181|"~     Symptoms such as diarrhoea and abdominal discomfort are common side effects of radiotherapy~     for tumours in the pelvis and usually occur within 2 weeks of starting treatment. Once the~     course of radiotherapy has been completed these symptoms usually subside, but in some~     patients they may continue and sometimes cause significant problems.~      It is not clear what processes are occurring to trigger such symptoms. There are a number of~     possibilities and we would like to investigate these further. If we can identify specific~     reasons for symptoms being worse in one patient compared to another, then we can try to~     either prevent or treat these. The aim of this study is to look for differences in the way~     that the bowel adapts to radiotherapy in patients who do and those who don't experience bowel~     symptoms during their course of radiotherapy.~   "
254475|NCT00220168|"~     The objective of this study is to assess the efficacy and toxicity of a 3 weekly regimen~     containing irinotecan combined with capecitabine in the setting of relapsed or refractory~     upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma~     or squamous cell carcinoma originating from the oesophagus, oesophagogastric junction or~     stomach who have previously received chemotherapy and have either failed to respond or who~     have relapsed within 3 months after an initial response will be eligible for treatment in~     this study.~      The response rate, failure-free survival and overall survival of treated patients will be~     evaluated. Toxicity and quality of life will also be monitored closely.~   "
254476|NCT00220155|"~     To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous~     infusion in patients with pretreated metastatic colorectal cancer.~   "
254477|NCT00220142|"~     To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity.~   "
254478|NCT00220129|"~     This is a study to investigate the efficacy and safety of epirubicin, cisplatin and~     capecitabine (ECX) as neoadjuvant therapy prior to radical chemoradiotherapy using~     capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized~     squamous cell carcinoma of the oesophagus.~   "
254479|NCT00220116|"~     To assess the efficacy and safety of the combination of capecitabine and oxaliplatin in the~     1st, 2nd or subsequent line treatment of metastatic colorectal cancer, and also in the~     neo-adjuvant and adjuvant setting of resectable metastases.~      Primary Endpoint: Objective response rates~      Secondary Endpoints: Treatment related toxicity Progression free survival (If not resected)~     Disease free Survival (From metastastectomy, if resected) Overall Survival 60 Day all cause~     mortality Number undergoing liver resections/curative resection (Ro) rate~   "
254480|NCT00220103|"~     To investigate the efficacy and safety of epirubicin, cisplatin and capecitabine as~     neoadjuvant therapy prior to radical resection in patients with newly diagnosed operable~     oesophageal adenocarcinoma.~   "
254495|NCT00219908|"~     The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone~     and interferon beta1b can delay disease progression of at least one point on EDSS scale in~     patients with clinically very active relapsing-remitting multiple sclerosis.~   "
254554|NCT00219128|"~     Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to~     placebo in patients with essential hypertension~   "
254481|NCT00220090|"~     Irritable Bowel Syndrome (IBS) is the most commonly identified functional gastrointestinal~     disorder, affecting 10-20% of the population in the Western world, seen predominantly in~     females and with a negative impact on quality of life, characterized by recurrent and often~     disabling abdominal pain associated with altered frequency or appearance or passage of the~     stool.~      IBS aetiology is unknown and its treatment remains largely empirical and directed to the~     relief of symptoms. One possible target for IBS treatment has been identified in drugs that~     modulate the action of Cholecystokinin (CCK), a peptide gut hormone implicated in the~     regulation of motor and sensory functions at various levels of the gastrointestinal tract.~      The biological actions of CCK in the gastrointestinal tract are mediated by CCK1-receptors.~      Dexloxiglumide is an oral potent and selective antagonist of CCK1-receptors. The mechanism by~     which dexloxiglumide might be beneficial in IBS is its ability to modulate visceral~     hypersensitivity and gut dysmotility.~      The DARWIN study has been designed to confirm the efficacy of dexloxiglumide according to a~     so-called randomized/withdrawal design. In this design all participants start the study~     treatment and only improved patients (the responders) are randomized to active treatment or~     placebo, expecting a more frequent and/or a more rapid relapse of their symptoms in patients~     randomised to placebo than those on active.~      Female and male patients, aged 18-70 yrs meeting IBS diagnostic criteria whose main complain~     is constipation, with a disease of at least moderate severity, will receive dexloxiglumide or~     placebo during a double-blind treatment phase of 24 weeks, following a first treatment of up~     to 12 wks during which patients will have to qualify as responders to the study treatment.~      The responder status of each patient over each 4-wk assessment period, will be based on a~     weekly global patient-based assessment of relief and control of symptoms using a~     telephone/internet-based diary.~      Additional secondary efficacy parameters will include: effect of treatment on IBS cardinal~     symptoms (e.g. abdominal discomfort/pain, bloating, straining, incomplete evacuation,~     urgency, stool frequency and consistency), on rescue laxative consumption, and on quality of~     life.~      Standard safety parameters include vital signs, adverse event reporting, physical~     examination, routine laboratory screen, 12-lead ECG and gallbladder ultrasound.~   "
254482|NCT00220077|"~     Knowledge of the impact of gene expression profiling could allow optimisation of chemotherapy~     regimens for individual patients. It could ensure that patients do not receive a particular~     form of chemotherapy if it is unlikely to benefit them, and in these circumstances an~     alternative form of chemotherapy that may prove beneficial could be selected. This~     information will therefore allow chemotherapy to be tailored to the individual tumour. It may~     help identify those patients with a poorer prognosis who could be selected for further~     therapy post surgery or a different treatment strategy at the outset.~   "
254483|NCT00220064|"~     The objective of this study is to assess the efficacy and toxicity of a 2 weekly regimen~     containing irinotecan combined with leucovorin-modified 5-fluorouracil in the setting of~     relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or~     metastatic adenocarcinoma originating from the oesophagogastric junction, stomach or pancreas~     who have previously received chemotherapy and have either failed to respond or who have~     relapsed after an initial response will be eligible for treatment in this study.~      The response rate, failure-free survival and overall survival of treated patients with the~     two different regimes will be evaluated. Toxicity and quality of life will also be monitored~     closely.~   "
254484|NCT00220051|"~     To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by~     capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the~     treatment of patients with locally advanced or inoperable rectal cancer.~   "
254485|NCT00220038|"~     The ability to smell varies greatly between different individuals. Some people are unable to~     detect an odor that most people can smell. It is not known what causes these individual~     differences. Humans have about 1000 genes for odorant receptors that bind and detect odor~     molecules. It has been shown that some of these genes exist in two forms: a functional one~     and one that has been mutated and is therefore no longer functional. We think that people who~     can not smell a specific odor may carry the non-functional form of the gene for the receptor~     that detects the odor molecule. To test this hypothesis we want to find people who can not~     detect a specific smell and then compare their odorant receptor genes with those of people~     who can smell the odor.~   "
254486|NCT00220025|"~     This study offers narrowband UVB light therapy to patients with both light and dark skin~     types who have 10% of their body involved with psoriasis vulgaris.~   "
254487|NCT00220012|"~     This study looks at the effect of folate supplementation and depletion on the blood cells and~     the colorectal cells. To examine the effect of these changes, blood samples and colorectal~     biopsy samples are collected. The genetic material (RNA and DNA) is examined to see what~     changes occur during the depletion and supplementation of folate. The hypothesis is that~     folate may help prevent colon cancer~   "
254488|NCT00219999|"~     The purpose of this study is to measure specific chemokines, antibodies, and~     antibody-producing B cells in the blood of patients with hepatitis C virus (HCV) infection.~     Our hypothesis is that changes in chemokine levels affect the development of an effective~     immune response against HCV.~   "
254489|NCT00219986|"~     Monoclonal antibody infusions will prevent rebound of viremia in well-suppressed~     HAART-treated individuals who began therapy during acute and early HIV-1 infection.~   "
254490|NCT00219973|"~     The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation~     LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e. administering the first~     dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in~     oncological surgery.~   "
254491|NCT00219960|"~     To determine the effect of North American ginseng on blood pressure in individuals with~     hypertension.~   "
254492|NCT00219947|"~     To study the collection of blood from individuals known to be at high risk for HIV-infection~     or who have been recently infected with HIV.~      The data collected are used for diagnostic, prognostic and management decisions as outlined~     by current HIV-1 Treatment Guidelines.~   "
254493|NCT00219934|"~     Group A: Long-term follow-up is needed for subjects identified as acute or early in the~     course of HIV-1 infection, independent of decisions regarding therapy with highly active~     anti-retroviral therapy (HAART).~      Group B: This protocol will also be offered to subjects who were diagnosed with acute HIV-1~     infection in the past and have been participating in an ADARC/Rockefeller University Hospital~     treatment protocol for acute HIV-1 infection, and currently have a viral load consistently~     less than 50 copies/ml on current treatment (Group B)~   "
254494|NCT00219921|"~     There are several treatments for postoperative pain after Hip Replacement Surgery. However,~     some require an intravenous line which may interfere with rehabilitation after surgery. This~     study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery.~     Patients will either receive pain treatment at surgery, continuous intravenous pain~     treatment, or both. In the first two days after surgery, patients will frequently be asked to~     rate their pain, and use of other pain medication will be monitored.~   "
254496|NCT00219895|"~     Specific Aim: To determine whether neutrophils, active elastase, and cytokines measured in~     sputum induced using hypertonic saline are useful screening tests for determining if a~     particular agent with known anti-inflammatory properties is a suitable candidate for more~     extensive clinical trials in patients with CF. This aim will be addressed using an~     anti-inflammatory agent, ibuprofen, that has been shown to have clinical benefit in CF. A no~     treatment arm will be included as the control group.~   "
254497|NCT00219882|"~     The purpose of this study is to assess the safety of advancing doses of curcuminoids~     administered orally for fourteen consecutive days in adult subjects with cystic fibrosis (CF)~     who are homozygous for ΔF508 CFTR.~   "
254498|NCT00219869|"~     Most patients with CPTH present with additional major cognitive, behavioral and somatic~     problems. Most drugs used currently have a negative influence on cognition. Therefore,~     treatment strategies addressing both the headache and cognitive disturbances in patients with~     CPTH are necessary. (CPTH; Chronic Post Traumatic Headache).~   "
254499|NCT00219856|"~     Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No~     data are available concerning the potential benefit of a total anaesthesia with propofol in~     partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver~     insufficiency that could be related in part to the oxidative stress induced by clamping the~     hepatic vessels during the surgical intervention. Our hypothesis is that propofol, by~     increasing liver resistance to this ischemia-reperfusion phenomenon, could improve the~     remaining liver function recovery, and therefore could reduce post surgical morbidity.~      The aim of the study is to evaluate the anti oxidant effects of propofol compared to another~     widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection~     with hepatic vessels clamping. The primary endpoint will be the level of malondialdehyde (a~     plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.~   "
254500|NCT00219843|"~     The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the~     treatment of metastatic melanoma. This study will also include a preliminary assessment of~     response of treated and untreated lesions by clinical evaluation at follow-up of 12 to 24~     weeks following IL PV-10 treatment.~   "
254501|NCT00219830|"~     The purpose of this study is to investigate if a home-based walking program is an acceptable~     alternative for those who choose not to attend formal cardiac rehabilitation programs and if~     such a program has an effect on coronary risk or physical fitness.~   "
254502|NCT00219817|"~     Anorexia and weight loss are devastating complications in late-stage cancer patients and is~     strongly associated with mortality in these patients. Activation of Ghrelin receptors have~     been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity~     and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced~     anorexia and weight loss. This study will test the safety and efficacy of RC-1291 in the~     treatment of cancer patients with anorexia and weight loss.~   "
254503|NCT00219804|"~     The primary objective of this study was to establish the absolute reduction of chorea in~     participants with Huntington's disease(HD) treated with tetrabenazine or placebo~   "
254504|NCT00219791|"~     To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate~     (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with~     intrathecal MTX overdose.~   "
254505|NCT00219778|"~     The first indication of hysterectomies in France are uterine leiomyomas. When they are~     symptomatic leiomyomas are particularly responsables of an increase of menstruations duration~     and volume. Echography is the reference exam for the diagnosis. It exists two treatments~     ways:-firstly progestatives and antifibrinolytics for the treatment of hemorragic symptoms,~     -secondly LH-RH analogs for the treatment of leiomyomas volume and hemorragic symptoms but~     just used for a small period because of the risk of osteoporosis.~      Different studies with different doses of mifepristone were released. The authors observe a~     decrease of leiomyomas volume. Based on this experience the present placebo controlled study~     has for objectives:-to confirm the efficacy of 10 mg oral mifepristone during 24 weeks in the~     volume decrease and in symptoms of leiomyomas, - to assess the safety of the treatment. The~     aim is to avoid or delay the hysterectomy of non menopausal patients. During the study~     patients will be evaluated with biological exams, clinical exams, echographies, medical~     interrogations and their diary cards.~   "
254506|NCT00219765|"~     The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated~     with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous~     leukemia in myeloid acute phase.~   "
254507|NCT00219752|"~     The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in~     patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis~     of cml is being performed within 1 year. Quality of life will be carefully assessed.~   "
254508|NCT00219739|"~     To test whether increasing the dose of imatinib or combining it with IFNalpha or ara-C~     increases the rate of molecular response (as measured by the decrease in BCR-ABL transcripts~     after 12 months of treatment) in patients with previously untreated CML in chronic phase.~      To compare overall survival in a selected arm according to molecular response at 1 year from~     randomization with the reference arm.~   "
254509|NCT00219726|"~     The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in~     patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem~     cell transplantation.~   "
254510|NCT00219713|"~     Bone marrow biopsy is a painful medical procedure often performed with local anesthetic.~      Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients~     who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an~     equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement~     used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal~     ruler~   "
254511|NCT00219700|"~     To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and~     incidence of adverse events~   "
254512|NCT00219687|"~     The purpose of this study is to determine whether dispatcher-assisted CPR instructions with~     compressions and ventilations versus dispatcher-assisted CPR instructions with compressions~     only improves survival from out-of-hospital cardiac arrests.~   "
254515|NCT00219648|"~     PEP03 is a new chemical entity developed as a highly selective, potent, and orally active~     5-LO inhibitor. PEP03 exerts its action by blocking the generation of both cysteinyl LTs and~     LTB4. These LTs have been associated with the inflammatory response in the lung and with the~     clinical sequelae, including bronchospasm. Preclinical pharmacological in- vitro, ex-vivo and~     in-vivo testing indicates that PEP03 has multiple beneficial actions including prevention of~     bronchoconstriction, and reduction of vascular leakage, cellular infiltration, and bronchial~     hyperresponsiveness.~      Clinical studies in asthmatic patients indicate that PEP03 improved FEV1 and other secondary~     endpoints, such as morning and evening peak flow, daytime and nighttime symptoms score,~     beta-agonist use, physician’s and patient’s global impression of change. Since leukotrienes~     have been suggested to be involved in the pathophysiology of COPD, this study is designed to~     explore the clinical utility of PEP03 for the treatment of moderate COPD.6; 7; 8; 9~   "
254516|NCT00219635|"~     Assessment of efficacy and safety UK-390,957~   "
254517|NCT00219622|"~     This an initial proof of concept, phase to study to assess the safety and efficacy of~     tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary~     Disease~   "
254518|NCT00219609|"~     To determine whether UK-390,957 is a safe treatment for premature ejaculation.~   "
254519|NCT00219596|"~     to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and~     Timolol in subjects with open-angel glaucoma or ocular hypertension~   "
254520|NCT00219583|"~     Assessment of efficacy and safety UK-390,957.~   "
254521|NCT00219570|"~     To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and~     safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne~     vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify~     the clinical positioning of Dalacin T Gel.~   "
254522|NCT00219557|"~     This is a Phase 2 study being conducted at multiple centers in the United States, Europe and~     Canada. Patients having pancreatic cancer that is locally advanced or that has spread to~     other parts of the body (i.e., metastatic) are eligible to participate. Patients must have~     not had any prior systemic treatment for advanced disease. The purpose of the study is to~     test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine~     is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall~     survival.~   "
254523|NCT00219544|"~     This study will measure the impact of treatment with pregabalin in adult men and women who~     have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the~     peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).~   "
254524|NCT00219531|"~     The hypothesis of the study is that women perceive intestinal stimulation (rectal balloon~     distention) differently in different phases of the menstrual cycle, i.e there is an effect of~     hormones on the sensory pathway, and that this difference is reflected in the Central Nervous~     System processing of this signal. We also hypothesize that there is a difference in~     perception between control subjects and subjects with the irritable bowel syndrome.~   "
254525|NCT00219518|"~     We hypothesize that defecatory disorders can be described in mechanical terms which would~     allow a mechanistic description of disorders which would in turn allow better directed~     biofeedback mechanisms to treat disorders of defecation.~   "
254526|NCT00219505|"~     Acupuncture has been used for centuries in China in the treatment of diarrhea. Our hypothesis~     is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients~     with diarrhea-predominant IBS~   "
254527|NCT00219492|"~     Chest pain is a common clinical complaint. About 30% patients with chest pain will have a~     normal coronary angiogram and are described as having noncardiac chest pain (NCCP). It is~     estimated that 25% of the population complain of chest pain at some time in their lifetime.~     The pathogenesis of NCCP is unknown. Esophageal hypersensitivity as a result of inflammation~     is considered to be an important mechanism in the development of this pain sensation. Little~     is currently known about the interaction between inflammatory mediators and peripheral~     afferent nerve terminals in the esophagus. The mast cell is one of the most enriched~     pro-inflammatory cells in the gastrointestinal tract. Activation of the mucosal mast cell~     releases a variety of mediators into adjacent tissues. We hypothesize that mediators released~     by mast cells sensitize esophageal nociceptors and induce pain sensation.~   "
254528|NCT00219479|"~     It is unclear how enteral nutrition via a feeding tube should be given when a patient is~     receiving enteral Dilantin. Some caregivers hold the feedings for one hour before and one~     hour after the Dilantin dose to insure adequate absorption of the medication and some~     caregivers think that the feedings do not need to be interrupted.~      Hypothesis: Dilantin levels will remain therapeutic when enteral nutrition is given~     continuously during the administration of enteral Dilantin.~      The objective of this study is to determine Dilantin levels when enteral feedings are given~     by the continuous method. Thirty patients will be studied. When Dilantin levels are in the~     therapeutic range for 2 consecutive days on interrupted feedings (baseline), the patient will~     be switched to continuous feedings uninterrupted for the medication, for 7 days. Dilantin~     levels will be checked daily and if the levels become subtherapeutic an intravenous (IV)~     bolus of Dilantin will be given and the enteral dose will be increased (doses determined by~     primary caregiver). Serum albumin will be measured at baseline and at the beginning and end~     of each week, in order to calculate free Dilantin.~   "
254529|NCT00219466|"~     To evaluate whether Desitin; Zinc Oxide Diaper Rash Ointment (Desitin Original) and Desitin~     Creamy; Zinc Oxide Diaper Rash Ointment (Desitin Creamy) provide relief of the signs and~     symptoms associated with diaper rash after 12 and 24 hours of product application.~   "
254530|NCT00219453|"~     The primary purpose of this study is to determine the ability of the Protector Cap Jet~     Injector to prevent cross-contamination in the next injection sample. The hypothesis is that~     the Protector Cap Jet Injector will prevent contamination in the next injection sample, even~     following injection of volunteers with high levels of hepatitis B virus.~   "
254531|NCT00219440|"~     We hypothesized that a portion controlled diet would prevent the weight gain associated with~     the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months~     randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a~     standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.~   "
254534|NCT00219401|"~     The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal~     vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the~     Telethon Institute for Child Health Research and the Department of Paediatrics, University of~     Western Australia will collaborate to examine very closely the safety of neonatal~     vaccination, particularly with regard to impact on the development of immunity and response~     to other vaccines given to infants. This study will also provide a unique opportunity for~     training of PNG and Australian scientists in both countries.~   "
254535|NCT00219388|"~     The purpose of this study is to compare the effects of levosimendan with dobutamine on heart~     function in patients suffering of severe chronic heart failure.~   "
254536|NCT00219375|"~     The purpose of this study is to confirm the efficacy and safety of sivelestat in patients~     with acute lung injury associated with systemic inflammatory response syndrome. The results~     will be compared to the study with conventional treatment without sivelestat.~   "
254537|NCT00219362|"~     Prior pilot studies have shown that four monthly injections of ALVAC-HIV (vCP1433) are~     immunogenic in 60% HIV-infected patients with a boosting effect obtained after 1 or 2~     injections followed by a plateau or a decrease of these responses prior to interrupting~     therapy. The goal of the present study is to look for an improved vaccination schedule in~     terms of strength and duration of the HIV-specific immunity induced by the HIV-recombinant~     canary pox vector ALVAC-HIV (vCP1452) by testing a strategy of immunization involving a first~     series of two versus three monthly injections followed by a boost three months later.~   "
254538|NCT00219349|"~     The goals of this pilot study are as follows:~      1) To disseminate and examine the effectiveness of a manualized, individual,~     cognitive-behavioral psychotherapy (CBT) for adults with Generalized Anxiety Disorder(GAD),~     2) to test the effectiveness of augmentation (the addition of) antidepressant therapy in~     participants who do not fully respond to CBT, and 3) to examine individual and clinical~     predictors of non-response to CBT and predictors of response to augmentation antidepressant~     therapy. A related goal is to examine the maintenance of treatment gains obtained from CBT~     alone and CBT with augmentation antidepressant therapy, over a twenty-four month follow-up~     period. This study will serve as a pilot investigation in preparation for a larger federally~     funded study using this treatment approach. We hypothesize that CBT will result in remission~     (no longer having GAD) and/or high endstate functioning (clinically meaningful improvement)~     in approximately 40-50% of participants. Further, we hypothesize that augmentation~     antidepressant therapy in participants who do not fully respond to CBT will result in further~     clinically significant improvement.~   "
254539|NCT00219336|"~     The study evaluated the effectiveness of a mail-based self-guided motivational intervention~     based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) with female students and~     non-students 18 to 44 years of age living in Florida. The investigators hypothesize that the~     motivational intervention will significantly reduce more women's risk of an AEP than will an~     informational intervention aimed at preventing fetal alcohol syndrome. Materials will be~     available in Spanish and English~   "
254540|NCT00219323|"~     This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult~     patients with moderate to severe bronchial asthma.~      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES~   "
254541|NCT00219310|"~     This trial will assess whether RGH patients who have two recurrent episodes within a three~     month period would benefit from suppressive treatment and whether patients prefer episodic~     therapy or suppressive therapy for the treatment of their RGH.~   "
254542|NCT00219297|"~     The study objective is to evaluate the safety and efficacy of patupilone with respect to~     early progression and response of patients with non-small cell lung cancer (NSCLC) metastatic~     to the brain, who have progressed after chemotherapy, surgery and/or radiation.~   "
254543|NCT00219284|"~     To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with~     end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and~     entacapone.~   "
254544|NCT00219271|"~     The objective of this study is to assess the effect Of zoledronic acid on circulating and~     bone marrow-residing prostate cancer cells in patients with clinically localized prostate~     cancer~   "
254545|NCT00219258|"~     Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the~     efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other~     solid tumors with bone metastases.~   "
254546|NCT00219245|"~     Patients who completed the 12-week double blind protocol may enter this 26-week, open-label~     extension. This extension will give patients who complete the study an opportunity to receive~     treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive~     deficits related to traumatic brain injury. This extension will enable further evaluation of~     patients, as well as analyses to be conducted examining response to treatments in the~     original drug and placebo groups.~   "
254547|NCT00219232|"~     The goal of this research study is to evaluate, in the open-label extension phase, the safety~     and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's~     Disease~   "
254548|NCT00219219|"~     The present study will give information about the course over time in skeletal-related events~     (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg~     administered as a 15-minute infusion every 4 weeks for a maximum of 15 infusions. The~     protocol will enroll patients with recent diagnosis of bone metastases from prostate cancer~     who are hormone-refractory, hormone-naïve or still hormone-sensitive, that represent the~     entire population of prostate cancer patients~   "
254549|NCT00219193|"~     To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren~     / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately~     responsive to HCTZ 25 mg~   "
254550|NCT00219180|"~     To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan~     given to patients with essential hypertension~   "
254551|NCT00219167|"~     After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible~     patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg~     for a period of 8 weeks~   "
254552|NCT00219154|"~     This study is designed to compare the long-term efficacy and safety of an aliskiren based~     regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients~     with essential hypertension.~   "
254555|NCT00219115|"~     To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and~     HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25~     mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.~   "
254556|NCT00219102|"~     To evaluate the blood pressure lowering effect and safety of aliskiren used in combination~     with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not~     adequately responsive to the combination of valsartan and hydrochlorothiazide~   "
254557|NCT00219089|"~     To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension~     and diabetes mellitus~   "
254558|NCT00219076|"~     To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in~     combination with amlodipine 5 mg in patients with essential hypertension not adequately~     responsive to amlodipine 5 mg.~   "
254559|NCT00219063|"~     To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.~   "
254560|NCT00219050|"~     To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based~     regimen in the treatment of severe hypertension~   "
254561|NCT00219037|"~     Assess the long-term safety and tolerability of aliskiren, with the optional addition of~     HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and~     protect against end organ damage.~   "
254562|NCT00219024|"~     To demonstrate the efficacy and safety of aliskiren given to patients with essential~     hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with~     hydrochlorothiazide (HCTZ)~   "
254563|NCT00219011|"~     This study was designed to determine if patients, who have both high blood pressure and heart~     failure and are currently receiving drug treatment for heart failure, have an improvement in~     their heart failure signs and symptoms and other indicators of heart failure after being~     treated with aliskiren on top of their current heart failure treatment. Aliskiren is an~     investigational drug; its safety will also be evaluated in this trial.~   "
254564|NCT00218998|"~     To see how fast and how much physical training can reduce risk factors related to metabolic~     syndrome~   "
254565|NCT00218985|"~     The aim is to evaluate the effect of exercise training upon endothelial function in the~     mammary artery of patients who are scheduled for CABG, as well as study the functional~     properties of single cells isolated from a small biopsy of the left ventricle obtained during~     surgery.~   "
254566|NCT00218972|"~     Endurance training has a documented effect on hypertension. However, only low to moderate~     training intensity has so far been studied. High aerobic intensity should, from physiological~     considerations, prove more effective in also reducing high blood pressure. The present study~     is a randomised comparison of high versus moderate intensity versus training in groups, and~     general advice on 24 hour blood pressure in hypertensives. The training period is 12 weeks,~     with follow-up after 1 year. Maximum oxygen uptake, quality of life, left ventricular~     function and blood vessel reactivity are also measured.~   "
254567|NCT00218959|"~     In this study we want to compare Narrative Exposure Therapy to Treatment as Usual for~     traumatized refugees and asylum seekers in the Mid- Norway region. Clinicians in psychiatric~     outpatient clinics will deliver the two conditions to asylum seekers and refugees that~     qualifies for Posttraumatic Stress Disorder. We will investigate if refugees and asylum~     seekers will improve more with Narrative Exposure Therapy or Treatment as Usual, and if there~     will be any differences between improvement for asylum seekers compared to improvement for~     refugees with residential status.~   "
254568|NCT00218946|"~     Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is~     inserted?~   "
254569|NCT00218933|"~     Introduction: Moderate-intensity endurance-training is known to reduce symptoms, increase~     exercise tolerance, and improve quality of life in patients with chronic heart failure. The~     training benefits have mainly been attributed to adaptations in the peripheral circulation~     and skeletal muscle rather than to adaptations in cardiac performance. However attenuation of~     left ventricular (LV) remodelling has been documented in some studies. The effects of high-~     vs. moderate exercise-intensity on LV-remodelling and endothelial function in patients with~     post-infarction heart failure are not definitively established and were studied in the~     present study.~      Methods: Patients with post-infarction heart failure (45-87 yrs, 22-males, 5-females, all~     received b-blockers and ACE-inhibitors, EF 29%, peak oxygen uptake 13 ml/kg/min) were~     randomized to 12-weeks, 2-3 times per week, of either moderate exercise-intensity (70% of~     peak heart rate), high-intensity interval-training (95% of peak heart rate) or to a control~     group that received advise from their regular doctors. Patients in the two exercise-groups~     covered similar distance on the treadmill at each exercise-session so that only~     exercise-intensity differed; i.e. the duration of exercise was longer in the~     moderate-intensity group. Ultrasound was used to assess LV-dimension and function (including~     Tissue Doppler Imaging, TDI) and endothelial function in the brachial-artery.~   "
254570|NCT00218920|"~     The aim is to come to a consensus about how to prescribe exercise training that actually~     helps overweight and obese people. Thus, the present study determines the effects of several~     types of exercise training to define the one with the largest effect with the least effort.~   "
254571|NCT00218907|"~     This study compared the educational effectiveness of a ten-minute pre-test counseling video~     with the usual practice of a session with an HIV counselor.~   "
254572|NCT00218894|"~     Falls are the most serious and frequent home accident amongst elderly. Most falls occur~     during walking. Vision is reduced with ageing and visual impairments affect balance.~     Uncorrected visual deficits and balance problems are reported to be risk factors for falls~     and fall related fractures. The present project uses a longitudinal design and aims at~     assessing the impact of cataract surgery on balance and gait as risk factors for falls.~   "
254573|NCT00218881|"~     To compare HIV testing rates in ED patients offered video-assisted informed consent off-hours~     versus those referred to an HIV counselor the next business day.~   "
254574|NCT00218868|"~     The purpose of this study is to compare and evaluate the diagnostic performance of scrape~     cytology using two different cytological staining techniques, and to evaluate additional~     touch imprint cytology with that of histopathology of superficial basal cell carcinoma and~     actinic keratosis.~   "
254575|NCT00218855|"~     The purpose of this study is to test the effect of thalidomide in patients with multiple~     myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor~     doctor know which of these are given) in addition to the ordinary chemotherapeutic drug~     against multiple myeloma. We will find out for how long time the patients will stay free of~     the disease and for how long time they will live, and can evaluate whether thalidomide is a~     beneficial drug against this disease.~   "
254576|NCT00218842|"~     As designs of existing outcome studies are disparate and do not always relate well to a~     Swedish context, the need for further studies is obvious. Also, an empirical theory drawn~     from the best practice supporting autonomy and wellbeing for clients in a nursing home~     setting has not yet been fully depicted. The study described below intends to fill a gap in~     knowledge related to the effect of enhanced activities of daily living (ADL)-training,~     physical, and daily activities and staff education in a nursing home setting, based on a~     theory- and evidence-based intervention programme in a Swedish as well as a Nordic health~     care context. The aims of the study are to describe the impact of an individually tailored~     intervention program, in a nursing home setting, on:~        -  Physical capacity~        -  Degree of dependence in ADL~        -  Long-term participation in physical and/or daily activities~        -  Self-rated wellbeing~   "
254577|NCT00218829|"~     The purpose of this study is to registrate long time clinical and histological treatment~     response of basal cell carcinoma (BCC) lesions treated with one or two procedures of~     dimethylsulfoxide supported 5-aminolaevulinic acid photodynamic therapy (DMSO-PDT).~   "
254578|NCT00218816|"~     To determine if teaching parents and children to identify the child's asthma symptoms early~     and if teaching the appropriate use of a nebulizer will result in a decrease in emergency~     department visits.~   "
254579|NCT00218803|"~     To determine if teaching rural children with asthma and their parents about appropriate~     medication use, asthma triggers unique to a rural setting and increasing access to medical~     care will result in a decrease in emergency department visits.~   "
254580|NCT00218790|"~     A major component of this study is to test a novel application for a safe, non-pharmacologic,~     cost-effective intervention that is already in use in clinical practice - using cool~     dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis~     patients. We will also evaluate its effects on selected sleep-related physiologic,~     psychological, behavioral, and general health outcomes.~   "
254581|NCT00218777|"~     This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit~     reversal training (HRT) in treating chronic tic disorders (CTDs) in children and adolescents.~   "
254582|NCT00218751|"~     This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home~     visitation program for families at risk for child abuse, in promoting the health and~     development of children.~   "
254583|NCT00218725|"~     This study will examine the effectiveness of combining cognitive therapy with enriched usual~     care for preventing subsequent suicide attempts in people with a drug dependence who have~     recently attempted suicide.~   "
254584|NCT00218712|"~     This study will evaluate the effectiveness of a specialized cognitive-behavioral counseling~     intervention in reducing sexual risk behaviors in men who are HIV-infected and report having~     unprotected sex with male partners who are either not HIV-infected or do not know if they are~     HIV-infected.~   "
254585|NCT00218699|"~     This study will evaluate the effectiveness of a single specialized pre-test counseling~     session in reducing HIV infection risk behavior in men who are not HIV infected.~   "
254586|NCT00218686|"~     The purpose of this study is to evaluate a peer-based HIV prevention intervention that~     targets active injection drug users and their drug and sex partners in Chennai India.~   "
254587|NCT00218673|"~     The purpose of this study is to conduct a randomized controlled trial to assess the efficacy~     of a peer-educator intervention focused on injection drug users and their drug and sexual~     networks. We expect that participants who receive the intervention will demonstrate a~     reduction in the rate of HIV infection and HIV risk behaviors and members of their risk~     network will also demonstrate reductions in risk behaviors compared to those in the control~     group.~   "
254588|NCT00218660|"~     The purpose of this study is to see whether naltrexone is safe and useful in preventing~     alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of~     alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration~     (FDA) for the treatment of alcohol dependence. However, the medication was not approved as~     yet at the dosage we will use in this study. The dosage we will use for the study (150 mg),~     is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike~     other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone~     will not make you sick if you drink alcohol. Rather, people who are taking this medication~     have reported that it helps decrease the pleasure associated with drinking for them. This~     study is being conducted because the medication (Naltrexone) has not been well studied in~     people with both alcohol and cocaine dependence, so it is still investigational.~      We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy,~     this may lead to reduced cocaine use. We are also conducting this study to test two different~     types of psychotherapy as a method for reducing cocaine and alcohol use. One type of~     psychotherapy, CBT, is designed to help people learn to cope with situations that put them at~     high risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy, BRENDA,~     will use focuses on strengthening motivation to recover from cocaine and/or alcohol use, and~     on developing techniques to handle possible barriers to recovery. We seek to enroll 300~     patients in the study.~   "
254601|NCT00218478|"~     The majority of past research on marijuana treatment has specifically targeted the~     alleviation of withdrawal symptoms. Minimal focus has been placed on how altering craving~     effects may play a role in treating marijuana addiction. The purpose of this study is to~     compare the effects of marijuana-related cues versus non marijuana-related cues in~     individuals both addicted and not addicted to marijuana. In turn, this may help establish a~     better understanding of the effects of marijuana cravings and may lead to improved treatments~     for marijuana dependence.~   "
254696|NCT00217191|"~     Purpose of the study:~        1. To evaluate renal function maturation within the first month of life in very premature~          infants.~        2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter~          renal function maturation at short term and up to 28 days of life.~   "
254589|NCT00218634|"~     Patients with HIV, depression, and opioid-dependence are at high risk for poor health~     outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for~     depression and HIV medication adherence in patients with opioid dependence who are receiving~     methadone maintenance treatment. The project is based on our pilot work with close attention~     to NIDA guidelines for a staged approach to treatment development and testing (Rounsaville et~     al., 2001).~      Depression is highly comorbid with both HIV infection and with opioid dependence. Depression~     and substance abuse are both associated with poor adherence to antiretroviral medications.~     Patients with HIV, depression, and opioid dependence are at high risk for poor health~     outcomes. Cognitive-behavioral therapy is the most widely studied and efficacious~     psychosocial intervention for depression; and research by the PI and others has shown that~     cognitive-behavioral interventions have been successful in promoting adherence to HIV~     medications.~   "
254590|NCT00218621|"~     The purpose of this study is to evaluate the effects of drugs used by treatment providers on~     the fetuses and infants of opiate dependent women. The subjects in this study are women~     enrolled in a large, multi-site, double blind study that looks at the effects of methadone~     and buprenorphine treatment during pregnancy. This study will evaluate fetal and maternal~     biophysiologic data longitudinally during pregnancy to determine how these substances may~     affect fetal neurobehavior. Additionally, infant neurobehavioral assessments and measurements~     of infant vagal tone will be collected to see how methadone and buprenorphine differentially~     affect the neonatal abstinence syndrome, or withdrawal in exposed neonates.~   "
254591|NCT00218608|"~     Cocaine is an extremely addictive stimulant drug that directly affects the brain. It is used~     in several different forms and can be snorted, smoked, or injected to achieve the desired~     effect. Cocaine users are at risk for many health problems, both directly and indirectly~     related to the effects of cocaine. Disulfiram, a drug used to treat chronic alcoholism, may~     be effective in reducing cocaine use. This study will evaluate the effectiveness of three~     different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent~     individuals maintained on methadone.~   "
254592|NCT00218595|"~     The purpose of this study is to examine the efficacy of DBT compared to a standard drug~     counseling approach for the treatment of opiate addiction and borderline personality disorder~     (BPD). Treatment research has repeatedly shown that retention of BPD and substance addicted~     individuals to be the among the most challenging for therapists. DBT has established itself~     as one of the most effective treatments for treatment retention of these patients and for~     reducing parasuicidal and self-injurious behaviors.~      This study is one of two in a multi-site RCT for the treatment of opiate addiction. DBT has~     been shown to be efficacious for the treatment of BPD patients and it has been extended in~     this study to target addictive behaviors in these patients. The study consists of three~     treatment parts: weekly individual and group therapy and suboxone maintenance medication.~     Participants are provided therapy on a weekly basis for one year and suboxone for 2 years.~     Assessments for tracking outcome are conducted every 4 months.~      It is hypothesized patients in the DBT condition will show a reduction of substance use,~     parasuicidal and other psychological difficulties and these gains will be maintained through~     the year of follow-up assessments. In addition, it is predicted that adherence to DBT~     treatment protocols will be associated with improved outcomes. Finally, it is predicted that~     treatment dosage (average hours of therapy/week) will be positively related to clinical~     improvement.~   "
254593|NCT00218582|"~     The purpose of this study is to determine the effectiveness of adding dual focus 12-step~     self-help groups to standard treatment to improve behavioral outcomes for patients dually~     diagnosed with substance abuse and psychiatric disorders.~   "
254594|NCT00218569|"~     The purpose of this study is to examine whether Naltrexone and cognitive behavioral therapy~     can be helpful in patients who want to stop using cocaine and alcohol.~   "
254595|NCT00218556|"~     The purpose of this study is develop and test a cognitive-behavioral intervention to prevent~     depression in methadone maintenance patients receiving medical treatment for hepatitis C.~   "
254596|NCT00218543|"~     Studies have shown that individuals with attention deficit hyperactivity disorder (ADHD) are~     at greater risk for having a substance use disorder compared to people who do not have ADHD.~     Rates of cocaine abuse in adults with ADHD are significantly higher than they are in adults~     who do not have ADHD. Some clinicians suggest that adults with ADHD may abuse cocaine in~     order to self-medicate their ADHD symptoms. Atomoxetine is a drug that has been effective in~     treating ADHD. This study will evaluate the effectiveness of atomoxetine in reducing cocaine~     use in people with ADHD who abuse cocaine.~   "
254597|NCT00218530|"~     Stress is one of the more common reasons cited by addicts for continual drug use and relapse.~     Treatment approaches that target both drug-induced and stress-induced relapse may prove to be~     more beneficial than targeting drug-induced relapse alone. Lofexidine is a drug that reduces~     the physical symptoms of opiate withdrawal and may prove to have stress-reducing capabilites~     in drug addicts. The purpose of this study is to determine the maximal safe dose of~     lofexidine tolerated in naltrexone-treated heroin addicts and to find an optimal lofexidine~     induction schedule.~   "
254598|NCT00218517|"~     During the past 15 years, the demand for treatment for marijuana-related problems in the~     United States has increased nearly twofold. Selegiline is a medication currently used to~     treat nicotine dependence. The purpose of this study is to evaluate whether selegiline may be~     useful in treating individuals with marijuana dependence.~   "
254599|NCT00218504|"~     The majority of past research on marijuana treatment has targeted the alleviation of~     withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a~     role in treating marijuana addiction. Treatment with tetrahydrocannabinol (THC), the main~     ingredient in marijuana responsible for its reinforcing effects, may decrease marijuana~     cravings. The purpose of this study is to evaluate the effect of THC pre-treatment on~     responses to marijuana-related cues versus non marijuana-related cues in individuals addicted~     to marijuana.~   "
254600|NCT00218491|"~     Currently, no effective drug treatment exists for cocaine dependence. Glutamate levels are~     disrupted with long-term cocaine use. N-acetyl cysteine (NAC) is a drug that is metabolized~     by the body to form cysteine, an active compound that normalizes glutamate levels. The~     purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine~     dependent individuals.~   "
254602|NCT00218465|"~     The purpose of this study is to evaluate the efficacy of the glycine antagonist, GW468816,~     compared with placebo on duration of abstinence and rates of relapse in recently quit female~     smokers in a randomized, double-blind, five-week clinical trial.~      According to the investigators, the new medication, GW468816, is thought to send certain~     signals in the brain that may be effective in helping people stay abstinent after they have~     recently quit smoking. GW468816 is a non-nicotine drug.~      The investigators of this study hypothesize that subjects receiving GW468816 will demonstrate~     a significantly longer time to relapse to smoking than those in the placebo group, as~     measured by the primary outcome measure (see below).~   "
254603|NCT00218452|"~     The purpose of this study is develop and test the success of a new smoking cessation~     intervention that includes a component to eliminate binge drinking.~   "
254604|NCT00218439|"~     Smokers report that they often smoke cigarettes during stressful times. The combined effect~     of smoking and exposure to stress leads to exaggerated increases in blood pressure, heart~     rate and other measures of stress response. This combination may result in greater~     cardiovascular harm than either smoking or stress alone. The purpose of this study is to~     determine the effects of paroxetine on the response to stress after smoking.~   "
254605|NCT00218426|"~     Heroin addiction is a growing problem in Russia; individuals who enter heroin addiction~     treatment often relapse. Therefore, effective heroin addiction treatments are necessary to~     prevent relapse. The purpose of this study is to compare oral naltrexone with a naltrexone~     implant that provides opioid blockade for two months in preventing relapse to heroin~     addiction in St. Petersburg, Russia.~   "
254606|NCT00218413|"~     Nicotine is highly addictive and many individuals are unable to quit smoking even with~     treatment. The purpose of this study is to determine the effectiveness of various doses of~     NicVAX in treating nicotine dependent individuals.~   "
254607|NCT00218387|"~     Cocaine addiction is a serious health problem with no available medical treatment for~     preventing relapse. Modafinil, a medication that enhances mood, increases energy, and~     improves concentration, may be useful in preventing relapse among individuals with cocaine~     addiction. This study will evaluate the effectiveness of modafinil, in combination with~     cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.~   "
254608|NCT00218374|"~     Individuals who reduce or stop use of opioid medications are at risk for developing~     hyperalgesia, which is an increased sensitivity to pain. This study will compare the~     effectiveness of dextromethorphan, gabapentin, and oxycodone at reducing hyperalgesia in~     individuals addicted to opioids who are concurrently receiving methadone treatment.~   "
254609|NCT00218361|"~     The purpose of this study is to determine whether knowledge of post-session hydromorphone~     (HYD) availability reduces drug seeking behavior in heroin dependent individuals.~   "
254610|NCT00218348|"~     Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release~     of the neurotransmitter dopamine in the brain. The purpose of this study is to further~     examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.~   "
254611|NCT00218335|"~     The purpose of this study is to evaluate a peer-based HIV prevention intervention that~     targets active injection drug users and their drug and sex partners.~   "
254612|NCT00218322|"~     Adolescents with attention deficit hyperactivity disorder (ADHD) often develop substance use~     disorders (SUD). The purpose of this study is to evaluate the effectiveness of atomoxetine in~     treating adolescents dually diagnosed with ADHD and SUD.~   "
254613|NCT00218309|"~     The purpose of this study is to determine whether the opportunity to take free supplemental~     hydromorphone (HYD) influences drug seeking behavior in heroin dependent individuals.~   "
254614|NCT00218296|"~     Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks~     associated with its use. While treatment programs that focus on stopping tobacco use may be~     effective, past research has shown that interventions that specifically focus on reducing~     tobacco use may be equally effective and may motivate individuals to eventually quit using~     tobacco. This study will compare the effectiveness of a ST reduction treatment program versus~     a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in~     ST users.~   "
254615|NCT00218283|"~     Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health~     risks associated with its use as cigarettes. While there are many treatment programs that~     focus on stopping tobacco use, there are no interventions that specifically focus on reducing~     tobacco use. This study will evaluate the effectiveness of nicotine lozenge at reducing~     tobacco use in ST users.~   "
254616|NCT00218270|"~     Though spit tobacco is smokeless, it still affects the cardiovascular system and may be~     associated with heart disease, stroke, and high blood pressure. Long-term effects of~     smokeless tobacco (ST) include tooth abrasion, gum recession, mouth disease, loss of bone in~     the jaw, yellowing of teeth, and chronic bad breath. This study will assess the effectiveness~     of using tobacco free snuff in reducing levels of exposure to tobacco and associated~     toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine~     intake.~   "
254617|NCT00218257|"~     Past research has demonstrated that cocaine dependent women experience less severe responses~     to cocaine during the luteal phase of the menstrual cycle, when estrogen and progesterone~     concentrations are high. The purpose of this study is to determine whether administered~     progesterone reduces subjective and physiological responses to cocaine in cocaine dependent~     individuals.~   "
254618|NCT00218244|"~     Though spit tobacco is smokeless, it still affects the cardiovascular system and may be~     associated with heart disease, stroke, and high blood pressure. This study will assess the~     effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of~     exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit~     or sustain lower levels of nicotine intake.~   "
254619|NCT00218231|"~     Many individuals with schizophrenia smoke cigarettes but little is known about the factors~     that control smoking in people with schizophrenia. The purpose of this trial is to evaluate~     how bupropion, an antidepressant medication, affects smoking behaviors in individuals with~     schizophrenia who smoke.~   "
254697|NCT00217178|"~     Study Objective:~      1. To evaluate whether combined therapy with folic acid 2.5 mg/day, vitamin B6 50 mg/day and~     vitamin B12 1000 micrograms/day vs placebo reduces the rate of atherosclerosis progression,~     as evaluated by quantitative B-mode carotid ultrasound (US).~   "
254620|NCT00218218|"~     Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals~     without schizophrenia. While a great deal of research has been focused on smoking cessation~     programs for healthy individuals, little attention has been directed towards developing an~     effective smoking cessation treatment for schizophrenics. This project will evaluate the~     effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine~     withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking~     non-psychiatric control smokers.~   "
254621|NCT00218205|"~     The purpose of this clinical trial is to find out the effect of epirubicin with estramustine~     phosphate and celecoxib on PSA and objective response in patients with hormone resistant~     prostate cancer as well as evaluating the toxicity, quality of life of this combination.~     Celecoxib is an FDA approved drug to treat arthritis. Epirubicin, alone or with estramustine~     phosphate has been used in the treatment of hormone resistant prostate cancer. These drugs~     have demonstrated evidences of tumor blood vessel suppression and combination of these three~     drugs could possibly arrest further tumor growth or even make the tumor decrease in size.~   "
254622|NCT00218192|"~     The purpose of this study is to examine the efficacy of a brief motivational intervention on~     the cumulative incidence of Hepatitis C.~   "
254623|NCT00218179|"~     Lung cancer is the leading cause of cancer death in the United States. Currently it remains~     impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a~     mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and~     metabolism are a useful tool and available to use. The purpose of this study is to assess the~     link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.~   "
254624|NCT00218166|"~     Cocaine abuse continues to represent a significant public-health concern. Cocaine likely~     creates its addictive effects by increasing levels of dopamine, a chemical found in the~     brain. GABA agonists are chemicals that have the opposite effect of cocaine by inhibiting the~     release of dopamine. The purpose of this study is to determine whether GABA agonists reduce~     the psychological and physiological reinforcing effects of cocaine.~   "
254625|NCT00218153|"~     Naltrexone Augmentation of Nicotine Patch Therapy~   "
254626|NCT00218140|"~     Women typically have a more difficult time quitting smoking than men. Little research has~     been done to understand the differences between men and women that may cause this~     distinction. This study will assess whether the reduced effectiveness of nicotine replacement~     therapy in women is caused by gender differences in the withdrawal suppression induced by~     nicotine replacement therapy.~   "
254627|NCT00218127|"~     Heroin dependence remains a major addiction problem in the United States. The purpose of this~     study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin~     dependent individuals.~   "
254628|NCT00218114|"~     The purpose of this study is to compare the effectiveness of divalproex sodium (Depakote)~     versus placebo in treating disruptive behavior disorder and explosive tempers in adolescents~     and adults.~   "
254629|NCT00218101|"~     Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is~     to determine the effectiveness of buprenorphine in treating opioid dependent individuals who~     abuse opioids that are prescribed for chronic pain.~   "
254630|NCT00218075|"~     Cocaine dependence is a major public health problem; an effective primary treatment for~     cocaine dependent individuals has yet to be found. The purpose of this study is to examine~     the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. In~     addition, this study will examine the effects of incentive rewards for treatment compliance.~   "
254631|NCT00218062|"~     Cocaine dependence is a major public health problem; an effective primary treatment for~     cocaine dependent individuals has yet to be found. The purpose of this study is to examine~     the effects of d-amphetamine and modafinil, when given alone and in combination, in treating~     cocaine dependent individuals.~   "
254632|NCT00218049|"~     Cocaine dependence is a major public health problem; an effective primary treatment for~     cocaine dependent individuals has yet to be found. The purpose of this study is to determine~     the safety and effects of vanoxerine (GBR 12909) in treating cocaine dependent individuals.~   "
254633|NCT00218036|"~     The purpose of this study is to examine two medications, modafinil and citalopram, in the~     treatment of cocaine dependent individuals who are maintained on methadone.~   "
254634|NCT00218023|"~     Cocaine dependence is a major public health problem; an effective primary treatment for~     cocaine dependent individuals has yet to be found. The purpose of this study is to identify~     subpopulations and baseline conditions that are most responsive to treatment for cocaine~     dependent individuals.~   "
254635|NCT00218010|"~     Methadone is a drug that offers significant therapeutic benefits to opiate dependent women~     who are pregnant. Currently, it is the treatment of choice for this group of people. The~     purpose of this study is to determine the amount of methadone in the breast milk of women who~     are breastfeeding and taking methadone for opiate addiction. In addition, this study will~     evaluate the effects of methadone on infant neurobehavior.~   "
254636|NCT00217997|"~     Cocaine dependence is a major public health problem; an effective primary treatment for~     cocaine dependent individuals has yet to be found. The purpose of this trial is to evaluate~     aspects of treatment response in cocaine dependent individuals.~   "
254656|NCT00217724|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Nutritional supplements, such as glutamine, may prevent side effects caused by chemotherapy.~      PURPOSE: This randomized clinical trial is studying glutamine to see how well it works~     compared to placebo in preventing myalgia and/or arthralgia in patients who are receiving~     paclitaxel for cancer.~   "
254657|NCT00217711|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine~     when given together with oxaliplatin and irinotecan and to see how well they work in treating~     patients with advanced or metastatic colorectal cancer that cannot be removed by surgery.~   "
254698|NCT00217165|"~     The purpose of this study is to determine whether the amino acid taurine has effects on mood~     stability in bipolar disorder.~   "
254637|NCT00217984|"~     The purpose of this study was to determine the efficacy and cost-effectiveness of an~     intensive smoking cessation intervention that utilizes extended cognitive-behavioral therapy~     and combination nicotine replacement (CNR) in a randomized controlled trial. The intensive~     intervention was compared to usual care involving referral to a free-standing smoking~     cessation program that provides brief counseling and CNR. We recruited 162 smokers, ages 18~     to 75, who are enrolled in the Drug and Alcohol Treatment (DAT) programs at the San Francisco~     VA Medical Center (SFVAMC) and Santa Rosa VA Community-based Outpatient Clinic (CBOC). To be~     eligible, participants had to be abstinent from alcohol for at least one week, but not more~     than 30 days. We compared outcomes for the two study arms by assessing~     biochemically-validated point-prevalence smoking status at 3, 6, 9, and 12 months~     post-baseline and continuous abstinence over the 12-month follow-up. Expired-air carbon~     monoxide (CO) was used to biochemically verify 7-day point prevalence abstinence. We also~     conducted an economic analysis to determine the cost-effectiveness of the intensive~     intervention compared with usual care. We also examined cross-relapse patterns during the~     follow-up period, assessing changes in mood states and use of tobacco, alcohol, and other~     drugs at 3, 6, 9, and 12 months.~   "
254638|NCT00217971|"~     The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana~     addiction and withdrawal.~   "
254639|NCT00217958|"~     To improve disease outcomes through reduction in secondhand tobacco smoke exposure of~     children with asthma~   "
254640|NCT00217945|"~     To evaluate a model of shared decision-making for asthma treatment, appropriate to the needs~     of African American, Latino, Chinese, and other Asian and low income Caucasian patients to~     adherence to asthma controller medications in a two-year randomized clinical trial in 302~     minority and low-income adults, 18-70 years of age, with suboptimally controlled, persistent~     asthma, paralleling a simultaneous evaluation being conducted in 311 Caucasian and~     Asian/Pacific Island adults, (total n=613), and to examine psychological mechanisms mediating~     the effects of the intervention on adherence and of adherence on asthma outcomes.~   "
254641|NCT00217932|"~     The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote)~     versus placebo in treating children with temper outbursts and severe mood disorders.~   "
254642|NCT00217919|"~     The purpose of this study is to compare a health-counselor mediated telephone counseling~     intervention to usual care to reduce low density lipoprotein cholesterol (LDL-C) levels in~     patients with peripheral arterial disease (PAD).~   "
254643|NCT00217906|"~     This project will evaluate the effectiveness of a Head Start-based early intervention for~     designed to improve asthma management skill and practices of parents, pre-school children and~     Head Start staff.~   "
254644|NCT00217893|"~     This study will determine the effect of combining counseling, urine cotinine feedback, and~     incentives in reducing environmental tobacco smoke (ETS) exposure and susceptibility to~     smoking among high-risk preteens.~   "
254645|NCT00217880|"~     The purpose of this study is to identify biological markers of disease in patients with acute~     lung injury (ALI) that are predictive of either disease susceptibility or prognosis, or that~     identify novel targets of therapeutic intervention.~   "
254646|NCT00217867|"~     This study will use a comprehensive hospital discharge toolkit to implement up-to-date~     guidelines for cardiopulmonary diseases. The study will also include a computer-based~     patient-education program and a telephone-based post-discharge program, both designed for~     individuals with limited health literacy. The purpose of this study is to reduce early~     hospital readmission.~   "
254647|NCT00217854|"~     The purpose of this study is to examine inflammatory processes in the airway of moderate to~     severe persistent asthmatics who have persistent bronchial hyperreactivity despite chronic~     administration of inhaled glucocorticoids.~   "
254648|NCT00217841|"~     The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will~     improve outcome in MRSA infection.~   "
254649|NCT00217828|"~     To evaluate the therapeutic effects of the serotonergic agent, citalopram, on hostility and~     other behavioral risk factors, and biological markers of disease risk (serum lipids, insulin~     and glucose; autonomic balance and stress-related cardiovascular reactivity; platelet~     activation).~   "
254650|NCT00217815|"~     The study hypothesis is that the addition of Mycograb to docetaxel will improve outcome in~     advanced carcinoma of the breast.~   "
254651|NCT00217802|"~     The project evaluates an innovative educational intervention using telephone counseling based~     on self-regulation theory designed to address a problem heretofore overlooked in asthma~     self-management education: the unique needs of adult female patients.~   "
254652|NCT00217789|"~     The purpose of this study is to assess the lung cells of healthy volunteers and patients with~     stage II and III pulmonary sarcoidosis for pathogen specific memory immunity and gene~     expression patterns.~   "
254653|NCT00217776|"~     This random trial will deploy 2 interventions and a control group with eleven and twelve year~     old, low income, African American students in middle schools in Detroit, MI. The goals are to~     determine if 1) a self-management program focused on pre-teen capabilities designed for~     middle schools produces desired outcomes, and 2) if the program, enhanced by a peer~     component, improves upon outcomes. Outcomes of interest are symptom experience, quality of~     life, self-management, and school grades.~   "
254654|NCT00217763|"~     The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on~     therapy to most standard medication for Alzheimer's disease compared to placebo (inactive~     substance pill) in patients with mild to moderate Alzheimer's disease.~   "
254655|NCT00217737|"~     This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and~     bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and~     fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs~     used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as~     bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet~     known whether giving combination chemotherapy together with bevacizumab is more effective~     than combination chemotherapy alone in treating colon cancer.~   "
254658|NCT00217698|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Giving gefitinib as first-line therapy followed by gemcitabine and~     cisplatin after disease progression may be an effective treatment for non-small cell lung~     cancer.~      PURPOSE: This phase II trial is studying how well gefitinib works as first-line therapy~     followed by gemcitabine and cisplatin in treating patients with stage III or stage IV~     non-small cell lung cancer.~   "
254659|NCT00217672|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor~     cells by stopping blood flow to the tumor. It is not yet known whether giving docetaxel~     together with bevacizumab is more effective than docetaxel alone in treating breast cancer.~      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with~     bevacizumab works compared to docetaxel alone as first-line therapy in treating women with~     stage IV breast cancer.~   "
254660|NCT00217659|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     goserelin and anastrozole may fight breast cancer by blocking the use of estrogen by the~     tumor cells. Giving goserelin together with anastrozole may be an effective treatment for~     male breast cancer.~      PURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole~     works in treating men with recurrent or metastatic breast cancer.~   "
254661|NCT00217646|"~     This randomized phase I trial is studying the side effects and best dose of two different~     schedules of sorafenib in treating patients with refractory or relapsed acute leukemia,~     myelodysplastic syndromes, or blastic phase chronic myelogenous leukemia. Sorafenib may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the cancer.~   "
254662|NCT00217633|"~     This phase II trial is studying how well pelvic exenteration works in treating patients with~     recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent~     cervical cancer.~   "
254663|NCT00217620|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with~     advanced soft tissue sarcomas.~   "
254664|NCT00217607|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with~     locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be~     removed by surgery.~   "
254665|NCT00217594|"~     This study will evaluate the safety and effectiveness of a genetically engineered antibody,~     alemtuzumab (Campath[R]) on patients with myelodysplastic syndrome. MDS is made up of~     malignant stem cell disorders that can mean low levels of red blood cells-that is, anemia-and~     low counts of white blood cells and platelets. Patients with MDS are at risk for infection,~     spontaneous bleeding, and possible progression to leukemia, a cancer of bone marrow. Although~     bone marrow can produce some blood cells, patients with MDS experience a decrease in~     production of blood cells. Alemtuzumab recognizes specific types of white cells called~     lymphocytes and destroys them. This study will examine not only the usefulness of the~     medication but also the side effects in patients with MDS.~      Patients ages 18 to 72 who have MDS that requires transfusions and who do not have HIV or a~     life expectancy of less than 6 months may be eligible for this study. Screening tests include~     a complete physical examination and medical history. There will be a collection of about 8~     tablespoons of blood for analysis of blood counts as well as liver, kidney, and thyroid~     function; a pregnancy test; an electrocardiogram (EKG) to measure electrical activity of the~     heartbeat; an echocardiogram (ECHO), which uses sound waves to evaluate heart function;~     wearing of a Holter monitor for 24 hours while the electrical activity of the heart is~     recorded; and a bone marrow biopsy. Patients should not receive any vaccines when taking~     alemtuzumab or for at least 12 months after the last dose. In addition, patients should not~     take the herbal supplements Echinacea purpurea or Usnea 2 weeks before beginning the study~     and during it.~      For the study, all patients will receive a test dose of 1 mg of alemtuzumab infused into a~     vein during the course of 1 hour. If the dose is tolerated, the medication will be given at~     10 mg doses into the vein for 10 days, as an infusion of 2 hours. Blood samples of 2~     tablespoons will be taken daily, and vital signs will be measured daily. The ECHO and 24-hour~     Holter monitoring will be repeated after patients receive the last dose of the medication.~     Because suppression of the immune system results from a decrease in white cells that fight~     infections, patients will take medications to protect them against infections and to treat~     them if infections occur. If needed, patients will receive blood transfusions for their MDS.~     Side effects of alemtuzumab involve a temporarily significant lowering of the number of red~     blood cells, white cells, and platelets. Side effects of the infusion can be rigidity, or~     stiffness, and fever, as well as risks of infections resulting from the decrease of white~     blood cells. Blood counts and reactions to all procedures will be carefully monitored~     throughout the study. After patients receive the last dose of alemtuzumab, they will have~     follow-up by their referring doctor or at NIH. They must be able to return to NIH after 1~     month, 3 months, 6 months, and annually for 5 years after the study. At follow-up visits,~     there will be blood tests to reevaluate blood counts and test for the presence of viruses.~     Blood tests will be done weekly for the first 3 months after patients have completed taking~     alemtuzumab, every other week until 6 months, and then annually for 5 years. There will also~     be a repeat ECHO at the 3-month visit, and a repeat bone marrow biopsy at the 5-month and~     12-month follow-up visits, and as needed after that.~      This study may or may not have a direct benefit for participants. For some, the antibody may~     improve blood counts and decrease the need for transfusions. Knowledge gained in the study~     may help people in the future.~   "
254666|NCT00217581|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of~     tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as~     oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving bevacizumab together with~     oxaliplatin and docetaxel may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with~     oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or~     metastatic stomach or gastroesophageal junction cancer.~   "
254667|NCT00217568|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin~     works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary~     peritoneal cavity cancer.~   "
254668|NCT00217555|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and topotecan, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with topotecan~     works in treating patients with recurrent or persistent ovarian, fallopian tube, or primary~     peritoneal cavity cancer.~   "
254669|NCT00217542|"~     This phase I trial is studying the side effects and best dose of recombinant interferon~     alfa-2b when given together with azacitidine in treating patients with stage III or stage IV~     melanoma or stage IV kidney cancer that cannot be removed by surgery. Drugs used in~     chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b~     may interfere with the growth of tumor cells. Giving azacitidine together with recombinant~     interferon alfa-2b may kill more tumor cells.~   "
254670|NCT00217529|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as docetaxel and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving erlotinib together with docetaxel and carboplatin may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when~     given together with docetaxel and carboplatin and to see how well they work in treating~     patients with newly diagnosed stage III or stage IV ovarian epithelial, primary peritoneal~     cavity, or fallopian tube cancer.~   "
254681|NCT00217386|"~     RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may~     stimulate the immune system in different ways and stop cancer cells from growing. Giving~     anti-thymocyte globulin together with etanercept may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together~     with etanercept works in treating patients with myelodysplastic syndromes.~   "
254671|NCT00217516|"~     RATIONALE: The use of nutritional supplements, such as selenium, may stop prostate cancer~     from growing. Internal radiation, such as brachytherapy, uses radioactive material placed~     directly into or near a tumor to kill tumor cells. Giving selenium before brachytherapy may~     be an effective treatment for prostate cancer.~      PURPOSE: This randomized phase I trial is studying selenium to see how well it works compared~     to placebo in treating patients who are undergoing brachytherapy for stage I or stage II~     prostate cancer.~   "
254672|NCT00217503|"~     RATIONALE: Herpesvirus is found in the cancer cells of patients with primary effusion~     lymphoma. Antiviral drugs, such as zidovudine and valganciclovir, may be able to act against~     the herpesvirus in the cancer cells to help kill the cancer cells. Bortezomib may help the~     antiviral drugs kill the cancer cells. Draining the effusion removes fluid that has built up.~     Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of~     cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy, such as~     cyclophosphamide, doxorubicin, and etoposide, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Giving~     bortezomib together with antiviral therapy followed by effusion drainage, bevacizumab, and~     combination chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with antiviral~     therapy followed by effusion drainage, bevacizumab, and combination chemotherapy works in~     treating patients with primary effusion lymphoma.~   "
254673|NCT00217490|"~     RATIONALE: Eating a diet high in fruits and vegetables and low in fat may lower the risk of~     some types of cancer. Dietary counseling may be effective in helping women change to a~     healthy diet.~      PURPOSE: This randomized clinical trial is studying how well individual counseling and/or~     computer-based counseling work in helping healthy women adopt a cancer prevention diet.~   "
254674|NCT00217477|"~     RATIONALE: Paricalcitol may cause cancer cells to look more like normal cells, and to grow~     and spread more slowly. Drugs used in chemotherapy, such as gemcitabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving paricalcitol together with gemcitabine may be an effective treatment for~     cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of paricalcitol when~     given together with gemcitabine in treating patients with advanced cancer.~   "
254675|NCT00217464|"~     RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using~     fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.~      PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with~     recurrent prostate cancer.~   "
254676|NCT00217451|"~     Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic~     that has been shown to be effective against malaria, although it cannot achieve a total cure~     in all patients. A previous small study has shown that in combination with clindamycin, an~     commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of~     malaria parasites. The current study will evaluate the efficacy and safety of the combination~     given for three days in children with uncomplicated malaria in Gabon.~   "
254677|NCT00217438|"~     RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of~     chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using~     stem cells from the patient or an identical brother or sister, may allow more chemotherapy to~     be given so more cancer cells are killed. Giving maintenance therapy after a stem cell~     transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan~     is more effective in treating multiple myeloma (MM).~      PURPOSE: This randomized phase III trial is studying two different doses of melphalan to~     compare how well they work when given together with amifostine followed by one or two~     autologous or syngeneic stem cell transplants and maintenance therapy in treating patients~     with stage II-III MM~   "
254678|NCT00217425|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the~     growth of cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving bevacizumab together with combination chemotherapy may~     kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with several~     chemotherapy drugs (combination chemotherapy) works in treating patients with peripheral~     T-cell lymphoma or natural killer cell neoplasms.~   "
254679|NCT00217412|"~     This phase I trial is studying the side effects and best dose of vorinostat when given~     together with isotretinoin in treating young patients with recurrent or refractory solid~     tumors, lymphoma, or leukemia. Drugs used in chemotherapy, such as vorinostat, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Vorinostat may also stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the cancer. Isotretinoin may~     cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving~     vorinostat together with isotretinoin may be an effective treatment for cancer.~   "
254680|NCT00217399|"~     Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by~     blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast~     cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of~     estradiol by the tumor cells. Sometimes when hormone therapy is given, it does not stop the~     growth of tumor cells. The tumor is said to be resistant to hormone therapy. Giving sorafenib~     together with anastrozole may reduce drug resistance and allow the tumor cells to be killed.~     This phase I/II trial is studying the side effects and best dose of sorafenib when given in~     combination with anastrozole and to see how well they work in treating postmenopausal women~     with metastatic breast cancer.~   "
254743|NCT00216580|"~     The purpose of the study is to assess the effectiveness and safety of long-acting injectable~     risperidone in the treatment of patients in the early stage of psychosis~   "
254682|NCT00217373|"~     This phase I trial is studying the side effects and best dose of interferon alfa-2b when~     given together with vaccine therapy and GM-CSF in treating patients with locally advanced or~     metastatic cancer that makes CEA. Vaccines made from a gene-modified virus may help the body~     build an effective immune response to kill cancer cells that make carcinoembryonic antigen~     (CEA). Biological therapies, such as GM-CSF, may stimulate the immune system in different~     ways and stop cancer cells from growing. Interferon alfa-2b may interfere with the growth of~     cancer cells and slow cancer growth. Giving vaccine therapy together with GM-CSF and~     interferon alfa-2b may kill more cancer cells that make CEA.~   "
254683|NCT00217360|"~     This project is called “Falls Aren’t Us” and aimed at evaluating the effectiveness of a~     customised falls prevention program for people aged 60 and over who were presented to the~     hospital Emergency Department following a fall and being discharged home. Recruitment for~     this randomized controlled trial has commenced in late December 2002 from several major~     public hospitals in the western, southern, and northern parts of Melbourne Metropolitan~     Region. Consented participants will receive a comprehensive falls risk assessment within one~     week of being discharged home from the Emergency Department and at twelve month following~     this initial assessment. Their falls risks will be monitored for twelve months through a~     falls diary. Following randomization, participants in the intervention group will receive a~     customised falls prevention program in addition to the usual care being put in place from the~     hospital Emergency Department.~   "
254684|NCT00217347|"~     The exploration of evocative symptoms of esophageal reflux disease or dyspepsia is based on a~     relatively invasive endoscopic examination, often badly tolerated, and which, in France, is~     carried out in 50% of the cases under general anaesthesia. The development of a Capsule~     Endoscopy, of single use, of esophageal exploration (PILLCAM OESO), could allow a painless~     exploration of the oesophagus, without infectious risk.The aim of this study is to validate~     the information provided by the Esophageal Capsule Endoscopy compared to upper endoscopy in~     the screening of patients with gastroesophageal reflux disease or dyspepsia . For that these~     patients, after being informed and to have given their signed assent, will initially have an~     exploration by Esophageal Capsule Endoscopy and then, the very same day or within 3 days~     maximum, a upper endoscopy'. The information provided by the Esophageal Capsule Endoscopy~     then by the upper endoscopy will be analyzed by investigators different. This study should~     make it possible to evaluate the parameters of specificity, sensitivity and predictive values~     of Esophageal Capsule Endoscopy in this indication.~   "
254685|NCT00217334|"~     The Community Hypertension Assessment Trial (CHAT) is an investigation of the effect of~     community pharmacy based blood pressure (BP) monitoring sessions led by peer health~     educators, with feedback to family physicians, on the monitoring and management of blood~     pressure among older adults.~   "
254686|NCT00217321|"~     The purpose of the Parkinson's disease Registry is to develop a national and international~     database of persons with Parkinson's disease (PD). The Registry will be used to facilitate~     the development of new therapies and healthcare services to improve the quality of life for~     people with PD. It will also be a means for investigators in the field of PD to quickly~     identify and notify subjects about other research studies for which they are eligible.~      Objectives include:~        -  Assess current treatment approaches and develop best-practice guidelines~        -  Track the functional abilities, access to healthcare and cost of illness of people with~          PD over time~        -  Drive the development of innovative research projects~        -  Accelerate the process of informing patients of research projects for which they may be~          eligible~   "
254687|NCT00217308|"~     Purpose of the study is to determine the effect of probiotic lactobacilli on the vaginal~     flora and cytokine profile during pregnancy, and the incidence of preterm labour in women at~     high risk for preterm birth.~   "
254688|NCT00217295|"~     This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax~     added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction (~     a measure of brain shrinkage) and by clinical assessment scores to evaluate disease~     progression.~   "
254689|NCT00217282|"~     The combination of oxaliplatin and gemcitabine has proven activity in advanced non-small cell~     lung cancer (NSCLC). Due to its favorable toxicity profile, this combination is optimal for~     adding new agents. Bevacizumab is an anti-VEGF monoclonal antibody that has also shown~     favorable results in advanced NSCLC. This study will add bevacizumab to oxaliplatin and~     gemcitabine as first line treatment in patients with Stage IIIB and IV NSCLC.~   "
254690|NCT00217269|"~     The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor~     Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary~     Stent System for the treatment of single de novo lesions in native coronary arteries with a~     reference vessel diameter (RVD) of 2.5-3.5 mm.~   "
254691|NCT00217256|"~     To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor~     Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher~     Sirolimus-Eluting Coronary Stent System for the treatment of single de novo lesions in native~     coronary arteries 2.5-3.5 mm in diameter.~   "
254692|NCT00217243|"~     In order to be able to study the effects of evoked fields with magnetoencephalography (MEG)~     in two groups of patients, comparison is made with a group of healthy volunteers.~   "
254693|NCT00217230|"~     The purpose of this study is to determine the efficacy, safety and tolerability of the liquid~     formulation of CAIV-T against culture confirmed influenza illness in adults aged 60 years and~     older. In addition this study aims to demonstrate superiority of CAIV-T when compared with~     placebo and the effect on economic resources.~   "
254694|NCT00217217|"~     Individuals with bipolar depression who had a particular kind of brain imaging reported~     improved mood after the imaging. This effect may be linked to the changing magnetic fields~     used during these magnetic resonance imaging studies. The current studies are designed to~     further explore the important parameters of this effect and to clarify the degree and~     duration of the mood effects.~   "
254695|NCT00217204|"~     The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT~     (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in~     infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess~     whether the consistency of the microtablets is acceptable for swallowing in infants and~     toddlers~   "
254699|NCT00217152|"~     This research is being done to study the effects (good and bad) of taking CellCept based on~     blood concentrations versus taking a fixed dose of CellCept without measuring the blood~     concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the~     immune system) which will be taken as part of this kidney transplant study. Cyclosporine or~     tacrolimus and corticosteroids are the two other drugs which will be taken.~   "
254700|NCT00217139|"~     The objective of the study is to evaluate the safety and efficacy of celgosivir plus~     peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic~     hepatitis C genotype 1 infection.~   "
254701|NCT00217126|"~     This study is being done to create a kidney transplant database with information from many~     transplant centers for the purpose of studying ways to help improve transplant outcomes and~     the care of transplant recipients. This is also being done to learn why kidney transplant~     recipients have worsening of their kidney function, and whether there are specific findings~     that could result in future treatments.~   "
254702|NCT00217113|"~     This is a study aimed at identifying Olmsted County senior citizens who are at risk for~     vulnerability. Those elders who screen affirmatively for vulnerability will be offered~     participation in a pilot intervention aimed at keeping seniors independent in the community.~     This intervention consists of a comprehensive geriatric home visit and the development of an~     individualized action plan aimed at preservation of function and independence. Participants~     will be followed for several months after their baseline assessment to evaluate~     implementation of recommendations.~   "
254703|NCT00217100|"~     This study is being done to compare arteriosclerotic cardiovascular disease in kidney~     transplant recipient taking a standard multivitamin versus those taking a multivitamin~     augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6.~   "
254704|NCT00217087|"~     This study is being done to see if treatment for esophageal cancer can be done using~     endoscopy for patients ineligible for surgical or radiological therapy. The standard method~     of treating this type of cancer is surgical removal of the esophagus. The study will~     determine if removing just the cancer with endoscopy is enough treatment or if the addition~     of another treatment called photodynamic therapy (treatment with a red light and a drug~     called sodium porfimer) is needed.~   "
254705|NCT00217074|"~     Methods: 103 participants, after being randomized to medical versus sham acupuncture received~     bi-weekly treatments for 5 weeks, after a baseline assessment week. They were then followed~     for an additional 7 weeks. Participants completed daily hot flash questionnaires, which~     formed the basis for analysis.~   "
254706|NCT00217061|"~     Background- Statins are a safe and effective therapy to reduce cardiovascular risk in~     patients with type 2 diabetes; however some patients are not prescribed statins, others do~     not take it even after being prescribed, and others stop therapy prematurely. Lack of~     knowledge or misinformation about statins may be responsible for inadequate statin use.~      Objective- To test the hypothesis that a formal, structured decision aid could correct~     deficiencies in the current decision-making process, increase statin use, and improve~     outcomes in patients with type 2 diabetes.~      Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot~     its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients.~      Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three~     months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE,~     knowledge about options, satisfaction with decisions, decisional conflict, encounter~     duration, and quality of life.~      Expected results- The investigators anticipate that this work will yield an effective and~     innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with~     a detailed users manual, will be directly applicable in clinical practice. Data and~     experience from this project will inform the planning and conduct of a randomized multicenter~     trial of the effectiveness of STATIN CHOICE in diverse practice settings.~      Significance- Patient participation in decision-making resulting in informed treatment~     decisions, as proposed in this study, will likely lead to improved quality of~     decision-making, more appropriate use of statins, and improved patient outcomes.~   "
254707|NCT00217048|"~     This study is being done to learn if yohimbine, a naturally occurring drug, affects the speed~     at which food travels through the stomach, intestines and colon, and if yohimbine affects the~     amount of liquid you can drink in a short period of time. Understanding how yohimbine works~     on the gut may help develop new treatments for patients with constipation. Yohimbine has been~     approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use~     as proposed in this study is considered investigational.~   "
254708|NCT00217035|"~     Proline is a non-essential amino acid that helps with collagen formation. Collagen is one of~     the main ingredients of skin, bone, tendons, and connective tissue. It is thought that~     proline becomes depleted in burn patients because it is being used in greater than normal~     quantities to help the injured skin and connective tissue heal. If this is true, then the~     body must look for alternate energy sources as proline becomes depleted.~      This study aims to evaluate 1)the metabolic kinetics of the amino acids proline, glutamate,~     and ornithine and 2) the effects of glutamine supplemented total parenteral nutrition (TPN)~     on the metabolism of these amino acids.~   "
254709|NCT00217022|"~     Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis.~     This study includes stool collections, blood draws, weekly questionnaires and a~     sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared~     with placebo for the treatment of diarrhea in lymphocytic colitis.~   "
254710|NCT00217009|"~     Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical~     creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A~     (PUVA) is commonly used to treat these conditions, but requires additional time for the hands~     and feet to soak in psoralens before the light treatment. Newer narrowband ultraviolet B~     (NBUVB) units have become available which allow for light treatment without soaking first.~     The purpose of this study is to determine if NBUVB is as effective as PUVA for hand and foot~     skin diseases.~   "
254744|NCT00216567|"~     The purpose of this study is to determine the efficacy and safety of Topiramate in comparison~     to Carbamazepine in Benign rolandic epilepsy.~   "
254745|NCT00216554|"~     The purpose of this study is to evaluate effect of risperidone as a long-term combination~     therapy to mood stabilizers in the treatment of bipolar mania~   "
254711|NCT00216996|"~     The Total Parenteral Nutrition (TPN)received as part of your routine burn care has optimal~     levels of protein and sugar, however the best mixture of amino acids for a patient with burn~     wounds is not yet known. Amino acids occur naturally in the body and the food we eat. The~     body combines amino acids to make protein. It uses the proteins to do things such as heal~     wounds, fight infection, and provide energy. We are studying if the body's use of protein is~     increased after receiving TPN containing the amino acid called glutamine. We hope to learn~     the best composition of TPN so that the body can more efficiently repair wounded tissues and~     recover earlier from an acute burn injury.~   "
254712|NCT00216983|"~     The overall purpose of the study is to evaluate the effect of depleting proline supply in the~     nutritional support regimen on proline metabolism in the burn patients, this includes the~     rate of proline oxidation after burn injury, the rate of proline de novo synthesis from its~     immediate precursors glutamate and ornithine. The specific aims of the proposed study are: 1)~     to determine the kinetic status of proline metabolism and whole body proline balance under~     the following nutritional states: (a) fasting; (b) regular total parenteral nutrition (TPN);~     (c)TPN with isonitrogenous depletion of proline, glutamate and ornithine metabolism under~     nutritional conditions studied in specific aim 1) above.~   "
254713|NCT00216970|"~     The purpose of the study is to understand the way the body uses amino acids and proteins in~     burned patient during the time they cannot eat normally. This study aims to understand the~     metabolism of the amino acid arginine in the body after burn injury. The results of this~     study will help determine the best composition of food needed during an acute burn injury so~     that body can more efficiently use the supplied nutrient for optimal burn wound healing and~     early recovery.~   "
254714|NCT00216957|"~     Coronary artery bypass grafting (CABG) is a well established treatment modality for patients~     with coronary artery disease. For 30 years now CABG operations have been performed with the~     help of the heart lung machine (Cardiopulmonary bypass). However, the heart lung machine is~     believed to be responsible for many of the side effects and complications seen in patients~     following CABG surgery. The organs most commonly affected are the brain, blood constituents,~     lungs and kidneys.~      In the last few years, stabilising devices have been developed that allow CABG operations to~     be performed safely without the use of the heart lung machine. Our hypothesis was that CABG~     done without the heart lung machine may be better tolerated by patients resulting in lower~     morbidity, increased functional outcome and shorter hospital length of stay.~      Enrolment into the trial was from 1998 to 2003 and included 300 patients. The last patient~     was enrolled in June of 2003. The initial results from the study suggest that excellent~     results can be obtained with both techniques and contrary to others no advantages could be~     demonstrated in in-hospital outcomes of patients performed without cardiopulmonary bypass~     (Legare et al. Circulation 2005).~   "
254715|NCT00216944|"~     The study aim is to compare a balanced anesthesia of the medicines used in all other age~     groups with the routine premedication in use for premature's with regards to the success in~     the intubation procedure, the need for analgesia during and after intubation and the stress~     reaction. In addition a pain scale for prolonged stress/pain for premature neonates in~     NICU-care will be validated, and the individual pharmacogenetic profile in relation to the~     need of morphine after the intubation will be investigated. The hypothesis is that balanced~     anesthesia before intubation facilitates the procedure, decreases the amount of stress and~     pain related to it, and causes a decreased need for analgesia after the intubation.~   "
254716|NCT00216931|"~     The purpose of this study is to determine if iloprost is effective in the treatment of~     elevated arterial pulmonary pressure in children with ventilator treated respiratory distress~     syndrome.~   "
254717|NCT00216918|"~     The purpose of this study is to evaluate the change in neuropsychological status from~     baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5~     diagnosed with ADHD.~   "
254718|NCT00216905|"~     Investigation of inpatients with alcoholism after detoxification with simultaneous~     Electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI).~   "
254719|NCT00216892|"~     Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:~        1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8~          weeks of calcipotriol cream~        2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks~          of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate)~          ointment on weekends~        3. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks~          of vehicle of calcipotriol cream~      The objective is to compare the efficacy and safety of the different treatment regimens~   "
254720|NCT00216879|"~     The purpose of the trial is to study the safety and efficacy of long term use of once daily~     applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to~     calcipotriol alone in the same gel.~      The primary response criteria will be the incidence of adverse drug reactions of any type,~     and the incidence of adverse events of concern associated with long-term corticosteroid use~     on the scalp.~   "
254721|NCT00216866|"~     The purpose of this study is to obtain an estimate of catheter survival in the setting of~     upper extremity deep vein thrombosis (UEDVT) in patients treated with dalteparin and~     warfarin.~      Anticoagulation with dalteparin and warfarin in patients with UEDVT secondary to central~     venous catheters in patients with an active malignancy is an effective therapy as quantified~     by the success of catheter preservation. A prolonged line salvage rate without a recurrence~     of UEDVT will improve the management of cancer patients who develop upper extremity deep~     venous thrombosis in the setting of a central venous (CV) catheter.~   "
254722|NCT00216853|"~     The purpose of this study is to determine the extent to which vaginal microflora and immune~     profiles of patients with urinary tract infection (UTI) differ from healthy controls.~   "
254723|NCT00216840|"~     The purpose of the study is to evaluate whether once daily topical treatment for up to 8~     weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and~     more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and~     calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.~      The primary response criterion is the number of patients with absence of disease and very~     mild disease after 8 weeks of treatment.~   "
254724|NCT00216827|"~     The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of~     calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more~     effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50~     mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.~      The primary outcome is the proportion of patients with absence of disease or very mild~     disease after 8 weeks of treatment.~   "
254725|NCT00216814|"~     To determine if there is an association between basic fibroblast growth factor,vascular~     endothelial growth factor, and interleukin levels and a patients response to BCG treatment (~     as standard treatment)in the urine of patients with superficial TCC. To determine if the~     levels of these angiogenic factors can predict response to BCG, disease recurrence,~     progression risk factors.~   "
254726|NCT00216801|"~     This pilot study will explore the relationship of Ochratoxin A (OTA) levels in patients with~     upper tract transitional cell (TCC), renal cell, and testicular cancers by measuring levels~     of OTA in serum and tumor samples. Dietary exposure will also be analyzed.~   "
254727|NCT00216788|"~     In a related study, the investigators have found evidence that patients with Barrett's~     esophagus have a leak for oral sucrose to leave their upper gastrointestinal tract, enter the~     blood, and be filtered into urine. The amount of sucrose appearing in an overnight urine~     sample can be used to indicate the presence of Barrett's esophagus and/or esophagitis in a~     patient reporting with reflux (GERD) symptoms. The leak is presumably in the Barrett's~     epithelium itself. This phenomenon will be used to test if a standard 8 week therapy of~     Nexium in a first-time-presenting GERD patient can reduce the leak as a means of assessing~     the efficacy of the drug in that patient. The investigators predict that Nexium will reduce~     leak in esophagitis but not Barrett's patients.~   "
254728|NCT00216775|"~     The purpose of this study is to evaluate the efficacy and safety of low-dose~     interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in~     patients with chronic hepatitis C.~   "
254729|NCT00216762|"~     This study is being done to find out if a drug called Rituxan (Rituximab) is safe and~     effective in treating people with chronic urticaria (hives) with persistent symptoms in spite~     of taking antihistamines.~   "
254730|NCT00216749|"~     This is a multicenter, open-label, prospective study of cilostazol use for prevention of~     recurrence in patients with cerebral infarction.~   "
254731|NCT00216736|"~     The aim of this project is to determine if a single dose of oral dexamethasone at the time of~     discharge from the emergency department (ED) [after successful treatment] prevents rebound~     headache.~      Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who~     suffer rebound headache after treatment for migraine in the ED.~   "
254732|NCT00216723|"~     This is a multicenter,open-label,prospective study of Aripiprazole use in patients with~     schizophrenia and bipolar disorder.~   "
254733|NCT00216710|"~     This study will assess the effectiveness of early home visitation by a professional in~     preventing child maltreatment, promoting healthy family functioning, and promoting child~     health and development.~      The investigators will test the following hypotheses regarding the effectiveness of early~     paraprofessional home visiting for at-risk families~        -  Actual home visiting services adhere to HFAK standards.~        -  HFAK promotes healthy family functioning, promotes child health and development, and~          prevents child abuse and neglect.~        -  Adherence to HFAK process standards is positively associated with achievement of~          outcomes.~   "
254734|NCT00216697|"~     One purpose of this study is to evaluate the effectiveness and safety in long term treatment~     for patients who completed preceding phase I/II study. The other purpose is to evaluate the~     effectiveness and safety of patients who are re-treated with this drug in recommended dose.~   "
254735|NCT00216684|"~     The purpose of this study is to verify the effectiveness, and safety in Japanese patients~     with chronic intractable pain after 4-week medication of fentanyl transdermal matrix patches~     containing either 12.5 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, or 100 mcg/hr, who have been~     switched from existing formulations, such as codeine, morphine hydrochloride, or fentanyl~     injectable. Furthermore, the safety and effectiveness of long term treatment such as 48 weeks~     are to be assessed, if possible.~   "
254736|NCT00216671|"~     The primary objective of this randomized trial was to investigate whether early initiation of~     treatment with Risperdal Consta after an acute episode was not inferior to the routine~     approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .~   "
254737|NCT00216658|"~     The purpose of this study is to verify the effectiveness, safety and pharmacokinetics of~     fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, or 50 mcg/hr in~     Japanese patients with cancer pain who have been switched from minimum amount of existing~     morphine preparations, such as equivalent to less than 45 mg/day of oral morphine, or oral~     oxycodone preparations equivalent to less than 30 mg/day.~   "
254738|NCT00216645|"~     The purpose of this study is to assess the effectiveness and safety of pegylated liposomal~     doxorubicin hydrochloride injection in Japanese patients with Mullerian carcinoma. This~     clinical study is a multi-center, non-randomized, open-label study in Japanese patients with~     Mullerian carcinoma (including epithelial ovarian carcinoma, primary carcinoma of fallopian~     tube, peritoneal carcinoma) with a prior history of platinum-based chemotherapy. Eighty~     patients will be administered intravenously at least two cycles of 50 mg/m2 of pegylated~     liposomal doxorubicin hydrochloride every 4 weeks to investigate the effectiveness and safety~     of the treatment.~   "
254739|NCT00216632|"~     The purpose of the study is to evaluate the maintained effectiveness of long-acting~     injectable risperidone (RISPERDAL® CONSTA™) compared with the previous treatment with oral~     olanzapine in non-acute subjects with schizophrenia or schizoaffective disorder considered in~     need of a therapy change.~   "
254740|NCT00216619|"~     The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of~     individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine~     headaches over a period of 26 weeks.~   "
254741|NCT00216606|"~     The purpose of this study is to evaluate the safety and effectiveness of individualized doses~     (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of~     chronic migraine headaches over a period of 16 weeks.~   "
254742|NCT00216593|"~     The purpose of this study is to assess the effectiveness and safety of galantamine~     hydrobromide treatment in patients with severe Alzheimer's disease.~   "
254746|NCT00216541|"~     The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in~     addition to best standard of care on hemoglobin levels and the need for red blood cell~     transfusions in cancer patients receiving chemotherapy as compared to patients receiving~     standard epoetin alfa treatment and best standard of care.~   "
254747|NCT00216528|"~     The purpose of this study is to evaluate symptomatic remission rate in patients with~     schizophrenia using long acting risperidone microspheres~   "
254748|NCT00216515|"~     The purpose of this study is to assess the efficacy of galantamine on the attention of~     patients with Alzheimer's Disease, how an improvement of attention of Alzheimer's Disease~     patients affects their activities of daily living, and the global benefit of galantamine.~   "
254749|NCT00216502|"~     The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in~     patients with Alzheimer's disease.~   "
254750|NCT00216489|"~     The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the~     treatment of patients with erosive or ulcerative gastroesophageal reflux disease (GERD) in~     routine primary health care.~   "
254751|NCT00216476|"~     The purpose of this study is to investigate whether a long-acting injectable formulation of~     risperidone provides better effectiveness over 2 years, as measured by the time to relapse,~     compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be~     investigated in a descriptive manner.~   "
254752|NCT00216463|"~     The aim of this study is to assess the safety and tolerability of varying dose and load~     regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.~   "
254753|NCT00216450|"~     The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the~     treatment of adult patients with Helicobacter pylori (H. pylori) infection in routine~     clinical practice.~   "
254754|NCT00216437|"~     Our long-term working hypothesis is that if 3-D radiation is combined with the effect of~     capecitabine one hopes to see improved and durable tumor response and survival with~     acceptable toxicity. The primary objective is to determine the maximum tolerated dose of~     capecitabine used along with 3-D conformal radiation therapy.~      Capecitabine will be taken by mouth each day of radiation. The total daily dose should be~     taken as two divided doses approximately 12 hours apart, within 30 minutes after eating,~     ideally after breakfast and the evening meal. The overall total number of patients expected~     to participate in this study could be as high as 30 depending on how the treatment is~     tolerated.~      The first group (3-6 patients) on the study will receive the drug (Xeloda®) at 600mg/m²~     (level 1) and radiation. If the first group does well, the second group of patients on the~     study (3-6 patients) will receive 825 mg/m² (level 2) and radiation. If the second group does~     well, the third group will receive 1,000 mg/m² (level 3) and radiation. If the first dose~     level of 600mg/m² is NOT tolerated, we will reduce the dose to 500mg/m² and enroll another~     3-6 patients at the lower dose.~      After the highest tolerated dose is identified, 12 additional patients will be treated at~     that dose to further test the safety of the treatment and better understand the effects of~     the treatment on disease with more patients.~      The following tests and procedures are part of regular medical treatment (standard care) for~     the disease and are also required for this study.~        -  physical examinations~        -  blood tests including pregnancy test~        -  urinalysis~        -  ECG (heart tracing)~        -  chest X-ray~        -  CT scan of the abdomen~      Follow-up visits are done 1 month after radiation, then 3 months later, then every 3 months~     for 2 years.~   "
254755|NCT00216424|"~     This study is designed primarily to establish efficacy and estimate resource utilization. The~     short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week)~     during the course of radiation therapy is efficacious in locally advanced, non-metastatic~     rectosigmoid carcinoma and will improve resectability. The long-term working hypothesis is~     that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one~     hopes to see improved and durable tumor response and survival with acceptable toxicity. In~     addition, it is expected that the simplicity of using an oral agent (capecitabine) will be~     associated with reduced cost and resource utilization.~   "
254756|NCT00216411|"~     The main purpose of this study is to assess the effect on Quality of Life of two cycles of~     Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on~     spasticity and function will also be measured.~   "
254757|NCT00216398|"~     The purpose of this study is to assess the efficacy, safety and patient acceptability of~     Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.~   "
254758|NCT00216385|"~     Tuberculosis is currently treated with a 6-month course regimen. During this time many~     patients might fail to adhere to treatment and default, increasing the risk of recurrent~     disease which might be multidrug resistant. A shorter duration of treatment is expected to~     provide improved patient compliance and at least equal or better clinical outcome. The aim of~     the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four~     months duration for the treatment of pulmonary tuberculosis,~   "
254759|NCT00216372|"~     The purpose of this study is to determine whether lanreotide 30mg microparticles are~     effective in the relief of clinical symptoms due to small bowel obstruction in inoperable~     patients with peritoneal carcinomatosis.~   "
254760|NCT00216359|"~     The Radata-Fuzeon cohort is an observational cohort study to gain a better understanding of~     Fuzeon (Enfuvirtide) in daily clinical practice. Patients planned to take this drug in a new~     antiretroviral combination therapy (ART) are eligible to participate in this observation.~      Physicians may register patients online via the internet. They are offered to get an expert~     advice suggesting therapeutics for a new ART.~      Observation interval is every three month. However physicians are allowed to initiate new~     diagnostics, expert advice and therapeutic changes independently from these intervals if~     necessary.~      Total observation time for each patients is planned for two years.~   "
254761|NCT00216346|"~     Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard~     therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for~     the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with~     anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in~     the treatment of patients with VL in India.~   "
254775|NCT00216151|"~     Evidence for the beneficial effects of bisphosphonates on bone resorption in multiple myeloma~     has been reported extensively, showing reductions in skeletal events and improvement of~     several biochemical variables in bone resorption. Zoledronic acid (Zometa®, CGP42446) is the~     most potent clinically available bisphosphonates, with the largest therapeutic ratio between~     the desired inhibition of calcium resorption and the unwanted inhibition of mineralization in~     vitro of all the bisphosphonates.~      This trial will investigate the efficacy of zoledronic acid in preventing skeletal events in~     patients with asymptomatic/early stage Multiple Myeloma~   "
254762|NCT00216333|"~     The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National~     Tuberculosis Programmes has been recommended by both the International Union Against~     Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages~     of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing~     the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding~     adherence and facilitating directly observed treatment. Recent bioavailability studies of~     four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing~     the efficacy of this compound, when given in the initial intensive phase of treatment of~     patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by~     four months treatment with a two-drug FDC of rifampicin and isoniazid.~   "
254763|NCT00216320|"~     To assess the effectiveness of a new stimulator (WalkAide) for the treatment of foot drop.~     The comparison will involve physical measurements (e.g. walking speed, physiological cost~     index, Modified Rivermead Mobility Index, etc.) and questionnaires on the quality of life and~     acceptance of the technology by stroke survivors.~   "
254764|NCT00216294|"~     The purpose of this study is to determine the safety and tolerability of RG1068 (Synthetic~     Human Secretin) when administered three times weekly to outpatients with obsessive compulsive~     disorder (OCD), to determine the impact of multiple subcutaneous injections of RG1068 on the~     symptoms of OCD, as measured by changes in clinical scales, and to evaluate the effect of~     RG1068 on ODC patients' anxiety, quality of life, and depression.~   "
254765|NCT00216281|"~     This is a randomized, placebo-controlled study to assess the efficacy and safety of ATX~     augmentation of CLZ as a treatment for the cognitive symptoms of schizophrenia. A total~     sample size of 126 subjects diagnosed with schizophrenia and being treated with the~     antipsychotic clozapine will undergo genotyping. These subjects will have an initial~     assessment at four weeks and regular follow-up assessments for a total period of 52 weeks.~     These subjects will be randomized to continued treatment with CLZ and augmentation with ATX~     or Placebo.~   "
254766|NCT00216268|"~     Japanese encephalitis is the single largest cause of viral encephalitis in the world today.~     It occurs in yearly post monsoon outbreaks in Uttar Pradesh and other parts of India and~     south east Asia. There is presently no antiviral drug of proven benefit for this illness and~     treatment is mostly supportive. The drug Ribavirin is already in the market in use for other~     indications. It has been found useful in West Nile encephalitis and various hemorrhagic~     fevers caused by related arboviruses. This is a double blind placebo of Ribavirin in Japanese~     encephalitis. To the best of our knowledge, this is the first such trial in the world. The~     study hypothesis is that children treated with ribavirin will be no different from those~     getting placebo in terms of mortality, length of hospital stay, days to return to~     consciousness and oral feeds, days to become afebrile and convulsion free and in 3 month~     sequelae rate.~   "
254767|NCT00216255|"~     The objective of the study is to determine the effects of pagoclone on the symptoms of~     Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent~     developmental stuttering in patients 18 to 65 years of age.~   "
254768|NCT00216242|"~     The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent~     influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe~     enough to limit normal daily activities and that are shown by virus culture to be caused by~     influenza viruses. The study will also examine the safety of the vaccine and collect~     measurements of the immune system responses produced by the vaccine.~   "
254769|NCT00216229|"~     To compare the efficiency of protection against hepatitis-B virus by administration of the~     combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the~     schedule 0-1-6 months.~        1. To compare the seroconversion (>= 1 IU/l) and seroprotection (>= 10 IU/l) rate at month~          6,7,12 and 13.~        2. To compare the distribution of anti-HBs at these different moments.~   "
254770|NCT00216216|"~     Patients with relapsed or chemotherapy-refractory SCLC have a dismal prognosis.~     Unfortunately, available treatments result in few durable responses. Pemetrexed is a~     well-tolerated agent, which is active in NSCLC. Since chemotherapy agents, which are active~     in NSCLC, are usually also active in SCLC, this trial will examine the efficacy and activity~     of pemetrexed in this palliative setting~   "
254771|NCT00216203|"~     Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping~     toxicity profiles. While 2-drug combination therapy has proven superior to single agent~     therapy in the first-line setting of NSCLC, no such phase III trials have been reported in~     the second-line setting. Therefore, the purpose of this study is to determine the feasibility~     of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating~     the activity of the combination in an expanded phase II setting. If the combination appears~     to have promising activity, further evaluation of this regimen may be warranted comparing it~     to single agent pemetrexed or cetuximab alone.~   "
254772|NCT00216190|"~     The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU~     subjects who are initially intubated, mechanically ventilated and require sedation for beyond~     24 hours.~   "
254773|NCT00216177|"~     The purpose of this study is to establish whether RA patients with moderate to severe disease~     activity with unsustainable response to infliximab 3 mg/kg every 8 weeks have better efficacy~     with adalimumab 40 mg s.c. eow compared to infliximab 3 mg/kg i.v. every 6 weeks.~   "
254774|NCT00216164|"~     Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic~     actions of several chemotherapy agents by enhancing sensitivity of tumor cells to~     chemotherapy-induced apoptosis. Gemcitabine, a nucleoside analog that is used in several~     other malignancies, has shown very promising activity in patients with refractory Hodgkin's~     disease and low-grade NHL. The combination of rituximab and gemcitabine may have synergistic~     cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved~     response rates and demonstrable clinical benefit.~      This trial will investigate the efficacy the combination of rituximab and gemcitabine in~     treating patients with relapsed or refractory DLBCL.~   "
254808|NCT00215722|"~     The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented~     at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.~      This study is aimed at establishing the efficacy and safety of the combination~     cetuximab/XELOX as first line therapy in patients with MCRC.~   "
254776|NCT00216138|"~     Recent progress in treatment of recurrent/metastatic SCCHN has been made with the~     introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and~     17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that~     is converted into 5-FU. Previous studies have shown that the capecitabine/docetaxel~     combination has a synergistic inhibition of tumor growth, resulting in significantly superior~     efficacy in time to disease progression (TTP), overall survival, median survival and~     objective tumor response rate compared to docetaxel alone.~      This trial will investigate the efficacy the combination of docetaxel and capecitabine in~     treating patients with recurrent/metastatic SCCHN.~   "
254777|NCT00216125|"~     In a previous phase II study, patients with pathological stage IIIb (without pleural~     effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic~     radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was~     selected based upon a survival benefit in patients with recurrent NSCLC.~      This trial will evaluate the role of consolidation therapy with docetaxel in patients with~     unresectable stage III disease. The purpose of the trial is to evaluate survival and~     toxicities of the regimens employed.~   "
254778|NCT00216112|"~     Imatinib mesylate is an inhibitor of the receptor tyrosine kinases for platelet-derived~     growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated~     cellular events. Docetaxel promotes cell growth arrest by inhibiting the deassembly of~     tubulin and by promoting at the same time microtubule assembly. Docetaxel has single agent~     activity in ovarian cancer with response rates of 30-40% in the platinum refractory setting.~     The combination of imatinib mesylate and docetaxel has potential synergistic effects, based~     on previous reports showing synergy in-vitro and in-vivo between PDGFR inhibitors or PI3K~     inhibitors and taxane chemotherapy.~      This trial will investigate the efficacy the combination of imatinib mesylate and docetaxel~     in treating patients with advanced, platinum-refractory ovarian cancer and primary peritoneal~     carcinomatosis.~   "
254779|NCT00216099|"~     Docetaxel-based therapy has been shown to prolong survival as first-line therapy for patients~     with hormone refractory prostate cancer (HRPC), and has become the standard of care. The~     beneficial effects of any therapy in HRPC may be diverse and include reduction in tumor bulk~     (when measurable), reduction in prostate-specific antigen PSA, reduction in symptoms~     (particularly pain), or stabilization of disease. Clear reductions in tumor bulk or PSA may~     provide objective evidence of a treatment effect, and stabilization of disease may be just as~     clinically meaningful in patients who are actively progressing prior to starting therapy.~     Pemetrexed has shown a broad array of activity in many diseases that until now were thought~     to be non-responsive to chemotherapy in the second-line setting.~      This trial is designed to further assess the efficacy, safety, tolerability, and~     pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has~     progressed following one prior taxane-based chemotherapy regimen for HRPC.~   "
254780|NCT00216086|"~     Preoperative induction chemotherapy has been successfully used in a variety of malignancies~     and provides several advantages over postoperative therapy. Combination of~     5-FU/Leucovorin/CPT-11 has demonstrated significantly better response rate than~     5-FU/Leucovorin alone. Replacing 5-FU with oral capecitabine in combination with CPT-11 has~     emerged as a potentially more effective, safe and convenient treatment option for metastatic~     colorectal cancer. Capecitabine is also well tolerated in concurrent treatment with~     radiation. Recent data has shown that preoperative radiation appears to be significantly more~     effective in increasing resectability rates.~      This trial will investigate the activity of capecitabine and CPT-11 combination in the~     preoperative setting followed by chemoradiation with capecitabine in locally advanced rectal~     cancer to improve response and decrease local recurrence. We will also study whether TS, TP,~     DPD and carboxyesterase expressions correlate with the objective response rate with this~     chemotherapy and chemoradiation regimen.~   "
254781|NCT00216073|"~     In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin~     with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of~     patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor~     selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher~     levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal~     tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to~     surrounding normal tissue. Trastuzumab is synergistic in vitro with multiple chemotherapeutic~     agents including the platinum compounds. Studies have shown the efficacy of trastuzumab~     combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer.~     This trial will investigate the activity of capecitabine and oxaliplatin administered with~     trastuzumab (CAPOX-T) in patients with HER2 overexpressing in patients with advanced disease.~   "
254782|NCT00216060|"~     Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent~     than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind~     trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these~     studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up~     to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials,~     risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density~     (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more~     potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to~     bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer~     patients has been well established; therefore, it is advantageous to assess the efficacy of~     oral bisphosphonate therapy.~   "
254783|NCT00216047|"~     HER2 gene amplification increases VEGF production in breast cancers; combined inhibition of~     HER2 and VEGF enhances response in xenograft models. The upregulation of VEGF in~     HER2-overexpressing breast cancers may contribute to the aggressive phenotype observed in~     HER2-positive breast cancer. New therapeutics targeting VEGF and/or its receptors may enhance~     the efficacy of trastuzumab monotherapy.~      This trial will investigate the safety and efficacy of combined HER2 and VEGF inhibition.~   "
254784|NCT00216034|"~     A randomized controlled study is conducted on patients with resected gastric cancer assigned~     to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective~     to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and~     explore the factors enhancing the antitumor effect of TS-1.~   "
254785|NCT00216021|"~     In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin~     with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of~     patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor~     selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher~     levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal~     tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to~     surrounding normal tissue. This trial will investigate the activity of this novel~     capecitabine/oxaliplatin (CAPOX) combination in patients with advanced disease. In addition,~     an exploratory analysis will correlate response with thymidine synthase and thymidine~     phosphorylase expression in primary tumor samples.~   "
254786|NCT00216008|"~     The purpose of this research study is to find out the effectiveness of the experimental~     combination of Docetaxel, Cisplatin, and radiation therapy administered prior to the surgical~     removal of your esophageal cancer.~   "
254787|NCT00215995|"~     This study is for patients with esophageal, esophagogastric, or gastric cancer that has~     spread to other parts of the body. The purpose of this study is to test the safety and~     effectiveness of a new experimental drug called ZD 1839 following initial therapy with two~     other chemotherapy drugs, called Irinotecan (CPT-11) and Cisplatin.~   "
254788|NCT00215982|"~     The purpose of this study is to find out how effective the new combination of the drugs~     Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon~     and rectal cancer. All three of these drugs are approved by the Food and Drug Administration~     (FDA) for the treatment of colon or rectal cancer. This however is the first time that these~     three drugs have been combined in this schedule for the treatment of colon/rectal cancer.~   "
254789|NCT00215969|"~     Pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality.~     The aim of this study is to identify pregnant women at risk for pre-eclampsia or other~     cardiovascular complications at a very early state of the disease, and thereby improve the~     current method of screening.~   "
254790|NCT00215956|"~     This is an open-label, single center, phase I study designed to determine the MTD or oral~     topotecan as a radiosensitizing agent in the treatment of rectal cancer patients. Sequential~     cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of~     concurrent radiation (45GY) over five weeks.~   "
254791|NCT00215943|"~     Investigators planned to accrue 176 participants, to compare the response rate, overall~     response rate and survival of patients with multiple myeloma (MM) when randomized to two~     regimens (thalidomide+Dexamethasone versus Vincristine+Adriamycin+Dexamethasone).~     Investigators also planned to test if treatment with zoledronate immediately prior to~     chemotherapy results in an enhanced response to treatment (i.e. increase in complete response~     rates).~   "
254792|NCT00215930|"~     The standard treatment for non-small cell lung cancer, stage IV or IIIB malignant pleural~     effusion is chemotherapy. The decision to use a regimen is currently determined by toxicity~     or by physician's preference. In this protocol, the treatment regimen will be assigned based~     on the patients' tumor molecular profile. A tumor molecular profile analysis will allow the~     physician to define a specific molecular portrait that shows the genetic basis of the tumor.~     This analysis results in a detailed report that will determine which chemotherapy will be~     assigned to the patient.~   "
254793|NCT00215917|"~     N-methyl-D-aspartate receptor (NMDAR) agonist, added to classical or atypical antipsychotic~     medication, has reduced negative, depressive, and cognitive symptomatology. We will be~     investigating the effect of D-serine, (DSR), a selective and potent NMDAR agonist, as~     monotherapy for treatment resistant schizophrenics.~      40 subjects on stable doses of risperidone will be randomized under double-blind conditions~     into a treatment group, which will receive D-serine 2100 mg, or a control group, which will~     continue to receive risperidone. Treatment will continue for 14 weeks.~      Symptoms and side effects will be rated biweekly with the CGI, PANSS, BPRS, SAS, AIMS, and~     UKU. Before and after the trial subjects will undergo neuropsychological assessments.~     Baseline and post-trial levels of amino acids relevant to glutamatergic neurotransmission~     (glutamate, glutamine, aspartate, glycine, serine, alanine) will be assessed.~      The primary outcome measures of the study will be the PANSS total scores and the positive and~     negative symptom cluster scores.~   "
254794|NCT00215904|"~     The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine~     (~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced~     dyskinesias.~      D-serine will be used as add-on therapy to on-going medications received by Parkinson's~     Disease patients. The rational for this study stems from observations made in pervious~     clinical trials with schizophrenia patients, in which it was demonstrated that D-serine~     adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by~     antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted~     effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's~     Disease.~      The study will have a crossover design in accordance to which each patient will receive, in~     random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have~     the opportunity to receive the experimental treatment.~   "
254795|NCT00215891|"~     Objectives:~      Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among~     patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level~     24 weeks after discontinuing therapy).~      Secondary~        -  To evaluate the safety and tolerability PEG Intron in combination with ribavirin for~          treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human~          Immunodeficiency Virus (HIV).~        -  To determine the early virologic response of patients receiving PEGIntron plus ribavirin~          at Treatment Week 24~      Study Design:~      All qualifying patients will enter the treatment phase and be dosed as follows:~      Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus~      Ribavirin:~        -  800 mg (400 mg bid) if body weight < 65 kg~        -  1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg~        -  1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg~        -  1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg~      At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from~     treatment and followed for a Post Treatment period of 24 weeks. Participants with~     undetectable HCV-RNA values at Treatment Week 24 will be randomized to either:~        -  Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin~          therapy, for a total of 48 weeks of treatment.~        -  Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin~          therapy, for a total of 72 weeks of treatment.~      Study Population:~      300 HIV infected adults with chronic hepatitis C infection who have not been treated~     previously with interferon therapy.~      Dosage and Administration:~      Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus~      Ribavirin:~        -  800 mg (400 mg bid) if body weight < 65 kg~        -  1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg~        -  1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg~        -  1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg~      Efficacy Evaluations:~      Laboratory analysis, liver biopsies, quality of life assessments, and changes in~     Peginterferona-2b and Ribavirin dosages will be obtained.~      Safety Evaluations:~        -  Assessment of laboratory evaluations~        -  vital signs~        -  incidence and severity of adverse experiences~        -  dose adjustments~        -  premature withdrawal for safety reasons~        -  progression of disease as measured by HCV viral load~        -  AIDS defining events~   "
254796|NCT00215878|"~     The aim of this study is to asses the effects of the NMDA receptor full agonist D-serine~     while used as adjuvant treatment for individuals suffering from chronic posttraumatic stress~     disorder (PTSD). Dysfunction of neurotransmission mediated at NMDA receptor plays a cardinal~     role in the pathophysiology of PTSD and PTSD patients typically suffer from cognitive~     dysfunctions and avoidance& depressive symptomatology that may be mediated by NMDA receptor~     function deficits.~      Thus, enhancement of NMDA activity by using D-serine may be beneficial in the treatment of~     PTSD. The study design involves two 6 week periods during which the participants will be~     randomly assigned to receive treatment with D-serine (~2g /dy)and placebo. This design allows~     each participant the opportunity to respond to the experimental treatment.~   "
254797|NCT00215865|"~     HRN-003 STUDY SYNOPSIS~      OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin~     among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing.~      OVERVIEW OF STUDY DESIGN: This is a multi-center, randomized, open-label clinical trial using~     PEGIntron weight-adjusted dose by subcutaneous injection weekly + ribavirin by mouth twice~     daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly + ribavirin by~     mouth twice daily for 48 weeks.~      STUDY POPULATION: 600 Adult patients with chronic hepatitis C virus infection who have~     previously failed to achieve a sustained virologic response following interferon alfa or~     interferon alfa-2b plus ribavirin therapy.~      DOSAGE AND ADMINISTRATION: Eligible participants will be randomized to receive PEGIntron~     weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth~     twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if~     weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for~     48 weeks.~      EFFICACY EVALUATIONS: Laboratory analysis, quality of life assessments, and change in study~     medication doses will be obtained.~      SAFETY EVALUATIONS: Assessment of laboratory evaluations, vital signs, incidence and severity~     of adverse experiences and progression of disease, as measured by HCV viral load.~      STUDY DESIGN~      This is a treatment protocol to evaluate the antiviral efficacy, safety and tolerability~     polyethylene glycol (PEG) conjugated interferon alfa-2b (PEGIntron) for the treatment of~     chronic hepatitis C virus infection in patients who have previously failed to achieve a~     sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin~     therapy. Patients will be stratified according to their response to the previous course of~     therapy (i.e. non-reponse or relapse virologic pattern~      This is a multi-center, randomized, open-label clinical trial that will involve approximately~     25 sites with an anticipated enrollment of 600 patients over a six-month period.~      Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5~     mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks~     OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by~     subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.~        -  Group A: PEGIntron weight -adjusted dose (1.5 mg/kg) by subcutaneous injection weekly +~          ribavirin 400 mg by mouth twice daily for 48 weeks (Total therapy x 48weeks).~        -  Group B: PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80~          KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for an~          additional 48 weeks (Total therapy x 48 weeks).~   "
254798|NCT00215852|"~     To conduct a randomized dose-ranging study to evaluate the safety and activity of orally~     administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic~     HIV-1 infection. The primary endpoints of the study will include an increase or upregulation~     in genes known to be mediators of interferon response. Secondary endpoints will include the~     absolute CD4 count and plasma HIV RNA levels.~   "
254799|NCT00215839|"~     Objectives:~      Primary To evaluate the safety, tolerability, and efficacy of Peginterferon a-2a plus~     Ribavirin for the treatment of chronic hepatitis C (CHC) infection in persons co-infected~     with human immunodeficiency virus (HIV) who have failed to achieve a sustained virologic~     response following previous interferon therapy.~      Secondary~        -  To evaluate the virological response to Peginterferon a-2a plus Ribavirin at weeks 12~          and 24 as compared to baseline values.~        -  To evaluate the sustained virological response Peginterferon a-2a plus Ribavirin at~          post-treatment weeks 4, 12, and 24 as compared to baseline.~        -  To evaluate the histological effects of long-term Peginterferon a-2a therapy through~          comparison of liver biopsy results following 96 weeks of Peginterferon a-2a therapy to~          baseline values.~        -  To evaluate the safety and tolerability of long-term Peginterferon a-2a therapy in~          patients who have previously failed to achieve a sustained virologic response following~          interferon therapy.~        -  To investigate the effects of long-term Peginterferon a-2a therapy on clinical outcomes~          of HIV disease.~      Study Design:~      All qualifying patients will enter the treatment phase and be dosed as follows:~      Peginterferon a-2a 180mg by subcutaneous route once weekly plus~      Ribavirin:~        -  800 mg (400 mg bid) if body weight < 65 kg~        -  1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg~        -  1200 mg (600 mg bid) if body weight > 85 kg~      Patients with undetectable levels of HCV-RNA at Treatment Week 24 will continue on previously~     assigned Peginterferon a-2a plus Ribavirin combo-therapy for an additional 24 weeks. Patients~     with detectable levels of HCV-RNA will be randomized to Peginterferon a-2a mono-therapy or no~     treatment for 72 weeks.~        -  Group A: Peginterferon a-2a 90mg mono-therapy for 72 weeks.~        -  Group B: No CHC therapy for 72 weeks~      All patients entering the study are required to have a baseline liver biopsy (within 18~     months of study entry). Patients entering the 72-week randomized arm of the trial will have a~     post-study liver biopsy upon completion of the trial.~      Study Population:~      100 HIV infected adults with chronic hepatitis C infection who have failed to achieve a~     sustained virologic response following previous interferon therapy.~      Dosage and Administration:~      Combo-therapy: Peginterferon a-2a 180mg by subcutaneous route once weekly plus~      Ribavirin:~        -  800 mg (400 mg bid) if body weight < 65 kg~        -  1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg~        -  1200 mg (600 mg bid) if body weight > 85 kg Mono-therapy: Peginterferon a-2a 90mg in 1mL~          solution administered subcutaneously once weekly.~      Efficacy Evaluations:~      Laboratory analysis, liver biopsies, quality of life assessments, and changes in~     Peginterferona-2a and Ribavirin dosages will be obtained.~      Safety Evaluations:~        -  Assessment of laboratory evaluations~        -  vital signs~        -  incidence and severity of adverse experiences~        -  dose adjustments~        -  premature withdrawal for safety reasons~        -  progression of disease as measured by HCV viral load~        -  AIDS defining events~   "
254800|NCT00215826|"~     The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the~     safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and~     immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute~     respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to~     determine an Alferon LDO dose level that increases or upregulates genes known to be mediators~     of interferon response. Secondary endpoints include the development of SARS symptomatology,~     rate of hospitalization, and mortality rate. In the event that no subjects with recent~     exposure to a person with SARS or possible SARS are available, this study will be conducted~     with 10 normal volunteers.~   "
254801|NCT00215813|"~     This is an open label study of Ampligen in patients with chronic fatigue syndrome.~   "
254802|NCT00215800|"~     multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.~   "
254803|NCT00215787|"~     Although nasal polyposis has been recognized as an inflammatory process for many years, the~     true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence~     rate after surgery has been reported as high as 87% within the first year after surgery.~     Anecdotally the Principal Investigator found an incidence of pH probe-proven~     laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his~     number of cases was small, the incidence of recurrence of polyps in these patients was 17%.~      The PI believes that such an association is too great to be explained by chance alone, and~     deserves further study. He anticipates two contributions to the literature from this study,~     the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients~     with polyposis, and the second showing the impact of reflux treatment on the recurrence rate~     of the polyps, initially after one year of therapy.~   "
254804|NCT00215774|"~     A randomized trial to test the hypothesis that short-term pharmacological reversal of~     electrical remodeling after cardioversion is equally efficient to prevent recurrent atrial~     fibrillation as standard long-term antiarrhythmic therapy.~   "
254805|NCT00215761|"~     Comparison of AF-Burden in patients with paroxysmal atrial fibrillation and the necessity of~     a Dual-Chamber-Pacemaker-Therapy either with a DDD[R]60-Stimulation or AF prevention pacing.~     All Patients were stratified according to their existing drug therapy, e.g. Beta-Blocker or~     ACE-Inhibitor.~   "
254806|NCT00215748|"~     This study is to explore the feasibility of an alternative dose of dexamethasone~     pre-medication in older breast and lung cancer patients who are receiving weekly docetaxel~     chemotherapy.~   "
254807|NCT00215735|"~     Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds~   "
254809|NCT00215709|"~     This pilot study is designed to determine the feasibility and safety of administering~     docetaxel at various dosing levels on a bi-weekly schedule in older men with hormone~     refractory prostate cancer.~   "
254810|NCT00215696|"~     The primary purpose of this study is to determine whether treatment with an experimental gene~     therapy (BIOBYPASS®) will reduce angina in study participants by stimulating the growth of~     new blood vessels. This will be measured by testing whether participants are able to exercise~     longer without experiencing angina after treatment, as compared to before treatment.~      Additionally, this study will collect information about any side effects that might be~     related to the treatment with the experimental therapy.~   "
254811|NCT00215683|"~     This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was~     to be treated until he was discontinued or withdrawn from the study, or a marketing~     authorization for degarelix had been obtained.~      The study was terminated when all ongoing participants had been treated for at least 5 years~     (including one year in the main study).~   "
254812|NCT00215670|"~     The objectives of this study are to characterize the safety, tolerability and~     pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6~     weeks for 54 weeks in patients with subfoveal choroidal neovascularization (CNV) secondary to~     AMD.~   "
254813|NCT00215657|"~     An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and~     Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients~   "
254814|NCT00215644|"~     The purpose of this study is to compare the effectiveness and safety of experimental~     treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Subjects invited to take~     part have metastatic cancer of the esophagus (gullet) or stomach.~   "
254815|NCT00215631|"~     Because of the high incidence of post-radiation erectile dysfunction (ED), up to 72% after~     external-beam radiotherapy, this patient category represents a most difficult therapeutic~     challenge. Therefore, prevention of ED could be more effective than treatment. Tadalafil, a~     new phosphodiesterase type 5 inhibitor, has been recently introduced. No studies have~     investigated the efficacy of tadalafil in preventing ED in patients undergoing radiotherapy~     for prostate cancer. Efficacy of tadalafil can last up to 36 hours after intake. This will~     result in a prolonged and continuos enhancement of penile vascular responsiveness. This~     randomized, double-blind, placebo-controlled study has been designed to evaluate the efficacy~     of 20-mg of tadalafil administered for 12 months in maintaining erectile function of potent~     patients undergoing external-beam radiotherapy for prostate cancer.~   "
254816|NCT00215618|"~     The purpose of this research is to determine the proportion of women who achieve permanent~     cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine~     bleeding.~   "
254817|NCT00215605|"~     The purpose of this study is to determine the best and safest dose of XL184 administered~     orally. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET, kinases implicated~     in tumor formation, growth and migration. To determine the highest safe dose, subjects will~     receive different amounts of the drug. The first group of subjects will receive the lowest~     dose of XL184. As long as no medically unacceptable side effects are noted, the dose will be~     increased for the next group. When the maximum tolerated dose (MTD) is reached, at least 20~     subjects with Medullary Thyroid Cancer (MTC) will be enrolled to evaluate the effect of XL184~     in this population.~   "
254818|NCT00215592|"~     To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients~     with refractory partial seizures.~   "
254819|NCT00215579|"~     As many as 75 percent of patients with schizophrenia have difficulty taking their oral~     medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly~     respond to these problems by adding adjunctive medications, despite the absence of systematic~     studies that support such practices. It is possible, however, that in many of these cases,~     the unstable course and/or unsatisfactory treatment response reflects incomplete adherence~     with the originally prescribed oral antipsychotic, rather than a need for adjunctive~     medications. This study will examine whether switching patients who demonstrate an unstable~     course and/or an unsatisfactory clinical response to a long-acting injectable preparation as~     the primary antipsychotic may enhance medication adherence and improve outcomes.~   "
254820|NCT00215566|"~     This study will evaluate the safety, tolerability and pharmacodynamics of the investigational~     drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.~   "
254821|NCT00215553|"~     Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to~     usual care alone consisting primarily of assisted (mechanical) ventilation in patients with~     acute respiratory distress syndrome(ARDS).~   "
254822|NCT00215540|"~     SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to~     prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia~     (BPD), in premature infants who have required continued intubation and received surfactants~     for the prevention or treatment of respiratory distress syndrome (RDS).~   "
254823|NCT00215527|"~     The investigators are studying the use of enzyme replacement therapy into the spinal fluid~     for treatment of spinal cord compression in the Hurler-Scheie and Scheie forms of~     mucopolysaccharidosis I (MPS I). Funding source -- FDA OOPD~   "
254824|NCT00215514|"~     The main purpose of this trial is to determine how well patients with gastric or~     gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin~     and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along~     with radiation therapy.~   "
254825|NCT00215501|"~     The purpose of this study is to test the safety of irinotecan and cisplatin in combination~     with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good~     and bad) these have on patients with unresectable, advanced solid tumors.~   "
254826|NCT00215462|"~     The purpose of this study is to collect anti-tumor activity of vinorelbine when given to~     patients with esophageal or gastric tumors. We will also collect information on the~     toxicities of vinorelbine in these patients.~   "
254827|NCT00215449|"~     The purpose of this study is to determine the efficacy and safety of the investigational drug~     in the treatment of COPD in comparison with a placebo.~   "
254828|NCT00215436|"~     The purpose of this study is to determine the safety and efficacy of the investigational drug~     in comparison with a placebo.~   "
254829|NCT00215423|"~     The purpose of this study is to determine which dose of the investigational drug is the most~     safe and effective for the treatment of COPD compared to the control drug~   "
254835|NCT00215345|"~     The purpose of this clinical trial is to find out the safety and effectiveness as well as~     patient’s quality of life on the combination of Taxotere and celecoxib on patients with~     hormone refractory prostate cancer. Celecoxib (Celebrex) is an FDA approved drug to treat~     arthritis. Taxotere (Docetaxel) is an FDA approved chemotherapy drug to treat certain forms~     of cancer. Both drugs have demonstrated evidences of tumor blood vessel suppression and~     combination of these two drugs could possibly arrest further tumor growth or make the tumor~     decrease in size.~   "
254836|NCT00215332|"~     To assess the clinical and radiographic outcomes through 5-years following treatment with~     CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one~     level (L4-S1).~   "
254837|NCT00215319|"~     The purpose of this study is to determine the clinical success of DePuy Spine Titanium~     Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one~     or two levels of degenerative disc disease of the lumbar spine. The observed success rate at~     24 months will be compared to an historical control group treated with the Lumbar I/F Cage~     with VSP System.~   "
254838|NCT00215306|"~     The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc~     compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at~     one level of the lumbar spine (either L4/L5 or L5/S1).~   "
254839|NCT00215293|"~     The purpose of this study is to determine the clinical success of the Cervical I/F Cage in~     treatment of one or two adjacent levels of degenerative disc disease of the cervical spine~     compared with standard of care treatment using either autograft, autograft with a plate or~     allograft with a plate~   "
254840|NCT00215280|"~     Mansonella perstans (M. perstans) infection is widespread in Uganda. Knowledge about the~     epidemiology of this infection, and of the morbidity it induces is poor, and no effective~     treatment is available. The study aims at providing data on diagnostic, epidemiological,~     morbidity and treatment aspects of M. perstans infections in Uganda.~   "
254841|NCT00215267|"~     The overall objective of the project is to contribute to an increased knowledge about the~     effect of praziquantel on schistosomiasis related morbidity and re-infection level among~     communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of~     improving the strategies for morbidity control.~      The study will be carried out in a high transmission area along Lake Victoria, in Mayuge~     district. It will be a randomised intervention study, comparing a single praziquantel~     treatment (40mg/kg) with two standard doses administered two weeks apart.~   "
254842|NCT00215254|"~     The purpose of the study is to examine the effectiveness and tolerability of quetiapine for~     the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be~     effective and well-tolerated for patients with social anxiety disorder.~   "
254843|NCT00215241|"~     The purpose of this study is to (1) compare the response of civilians with Posttraumatic~     Stress Disorder(PTSD) currently receiving sertraline without an optimal response to~     risperidone augmentation vs. placebo, and (2) to evaluate the tolerability of risperidone~     augmentation, and (3) to identifiy predictors of response to risperidone augmentation. the~     hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and~     effective.~   "
254844|NCT00215228|"~     Low heart rate variability is a marker of increased risk of cardiac mortality, and is~     observed in depressed coronary artery disease patients. Some antidepressants may themselves,~     however, decrease heart rate variability. We will test the hypothesis that greater reduction~     in heart rate variability will be associated with duloxetine (which has noradrenergic~     activity) than escitalopram (a selective serotonin reuptake inhibitor). We will also test the~     hypothesis that changes in heart rate variability are related to the magnitude of~     norepinephrine transporter occupancy.~   "
254845|NCT00215215|"~     To compare outcomes over 12 months of treatment with antiepileptic drugs (AEDs) alone or~     vagus nerve stimulation (VNS) therapy plus AEDs in patients who have partial seizures~     refractory to at least two, but not more than five, AEDs.~   "
254846|NCT00215202|"~     The use of Iressa will result in a greater than 20% response rate in patients with~     nonresectable adrenocortical cancer who have previously been treated with one other form of~     systemic therapy (either Mitotane or chemotherapy).~   "
254847|NCT00215189|"~     This pilot study evaluates an individualized health promotion program for people with mental~     illness receiving services at a mental health center in Keene, NH. The study will test the~     following hypotheses:~      Hypothesis 1: Compared to baseline (pre-study) levels, participants in the In SHAPE program~     will demonstrate increased physical activity as indicated by self-report and observed~     measures.~      Hypothesis 2: Compared to baseline (pre-study) levels, participants in the In SHAPE program~     will demonstrate improved fitness and health status as indicated by greater capacity on the~     6-minute walk test, one mile walk test, weight and body composition, and flexibility indexes.~      The following secondary (exploratory) hypotheses will be considered:~      Compared to baseline (pre-study) levels, participants in the In SHAPE program will~     demonstrate improved subjective health status, quality of life, mood, and self-efficacy. In~     addition, participants will demonstrate improved cardiovascular fitness as indicated by lower~     pulse rate and blood pressure.~   "
254848|NCT00215176|"~     The purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil~     in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of~     atypical depression. The hypothesis is that modafinil is safe and effective in the treatment~     of atypical depression.~   "
254849|NCT00215163|"~     Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD.~     However, although these interventions can be helpful, many patients remain symptomatic~     despite initial treatment. In this study, we will examine the relative efficacy of the~     addition of paroxetine-CR compared to placebo for patients remaining symptomatic despite a~     brief and intensive course of cognitive-behavioral therapy (CBT).~   "
254850|NCT00215150|"~     The purpose of this study is to examine the effectiveness and tolerability of augmentation~     treatment of ziprasidone to achieve remission among patients with social anxiety disorder~     (SAD) who did not remit on sertraline treatment alone~   "
254851|NCT00215137|"~     This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating~     obsessive-compulsive disorder (OCD) symptoms.~   "
254852|NCT00215124|"~     The objective is to obtain initial information regarding the safety and efficacy of the use~     of Filgrastim in the setting of acute myocardial infarction.~      The secondary objectives are to obtain information regarding the mobilization of relevant~     stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical~     information that may be helpful in the assessment of safety and efficacy of this drug as~     utilized.~      It is a one center, randomized, placebo controlled, dose escalation, blinded study. It will~     be 2:1 randomization with 9 patients total.~      Filgrastim 10 mcg/kg/day will be administered SQ for 5 days vs. placebo.~      Primary endpoint is death /or myocardial rupture or change in left ventricular ejection~     fraction from baseline to 30 days.~      9 pts. have already completed the first phase of the trial using Filgrastim 5 mcg/kg/day.~   "
254853|NCT00215111|"~     The purpose of this study is to test the hypothesis that a low-carbohydrate diet and a~     low-glycemic load diet will improve body mass index and result in more body fat loss than a~     control diet among overweight children ages 7 to 12. In addition this study is also designed~     to test the safety of diets with modified carbohydrate content as compared to a conventional~     weight management diet among younger overweight children.~   "
254854|NCT00215098|"~     The purpose of this study is to determine at risk populations for certain congenital heart~     defects or certain operative procedures and to define the associated morbidity secondary to~     chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access~     and hyperalimentation, subsequent infection.~   "
254855|NCT00215085|"~     The purpose of this study is to define the natural history of untreated cardiac tumors, study~     the pathology of primary cardiac tumors, review the surgical treatment and results of primary~     cardiac tumors and to determine the prognosis for these tumors.~   "
254856|NCT00215072|"~     The purpose of this study is to elucidate the patterns of death following congenital heart~     surgery.~   "
254857|NCT00215059|"~     Prospective, single center, descriptive study in 14 infants/children with multivessel~     pulmonary vein stenosis stratified for patients with or without underlying cardiac disease.~      Group 1: Patients without additional structural heart disease and multivessel pulmonary vein~     stenosis.~      Group 2: Patients with additional structural heart disease and multivessel pulmonary vein~     stenosis.~   "
254858|NCT00215046|"~     To evaluate the efficacy of the chemotherapeutic agents vinblastine and methotrexate in the~     treatment of two groups of children with multivessel pulmonary vein stenosis. Group 1 will~     contain children with multivessel pulmonary vein stenosis who do not have structural heart~     disease, and Group 2 will consist of children with multivessel pulmonary vein stenosis and~     concomitant structural heart disease.~      The primary outcome variable for efficacy is patient status one year after the start of~     treatment, where status is classified as either failure or success. Failure is defined as~     death or evidence of progressive obstruction at any time over the course of treatment as~     defined in the protocol. Success constitutes complete or partial response to treatment or~     stability of disease. Secondary outcome variables for efficacy are survival, time from~     diagnosis of pulmonary vein stenosis until failure, and change in patient classification on a~     scale measuring the severity of the obstructive disease.~      1.2 To assess the safety of vinblastine and methotrexate in the treatment of multivessel~     pulmonary vein stenosis.~      The primary outcome variable for safety is any occurrence of toxicity related to the~     administration of the chemotherapeutic agents over the treatment period.~   "
254859|NCT00215033|"~     The purpose of this study is to determine the significance of an elevated quantitative EBV~     PCR and to determine the relationship between a EBV PCR value and the risk of developing~     PTLD.~   "
254860|NCT00215020|"~     Isoprostanes are compounds that are produced as a result of oxidative damage to cell~     membranes. Elevated tissue, serum, and urinary isoprostane levels have been described in a~     number of inflammatory diseases. The goal of this study is to determine utility of measuring~     urinary isoprostane levels in pediatric patients with inflammatory and non-inflammatory~     gastrointestinal disease. Urine samples will be collected from pediatric patients undergoing~     procedures in the Children's Hospital endoscopy unit. Clinical disease activity will be~     assessed using a standardized clinical disease activityiIndex. Gross endoscopic and~     histologic findings will be graded. Previously obtained laboratory studies will also be~     recorded. Urinary Isoprostane levels will be determined using a commercially available assay.~     Isoprostane levels will be compared across conditions (IBD vs. non-inflammatory, Crohn's~     disease vs. ulcerative colitis) and tested for statistical significance. Similarly, disease~     severity and urinary isoprostane levels will be assessed. The sensitivity, specificity, and~     positive and negative predictive values of elevated urinary isoprostane levels at~     discriminating pediatric patients with inflammatory and non-inflammatory gastrointestinal~     disease will be calculated.~   "
254861|NCT00215007|"~     The purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial~     infections in the postneutropenic period in patients who have undergone allogeneic stem cell~     transplantation (SCT).~   "
254862|NCT00214994|"~     A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL~     Treatment in Adults with Generalized Anxiety Disorder.~   "
254863|NCT00214981|"~     Primary objective of this study is to evaluate the safety of treatment with modafinil~     film-coated tablet.~   "
254864|NCT00214968|"~     The primary objective of the study is to evaluate the safety and tolerability of treatment~     with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with~     narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to~     6 months.~   "
254865|NCT00214955|"~     A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of~     ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant~     Patients with Chronic Neuropathic Pain~   "
254866|NCT00214942|"~     A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of~     ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain in Opioid-Tolerant Patients~     with Chronic Low Back Pain~   "
254867|NCT00214929|"~     The best management in selected patients of pulmonary Embolism (PE) should be at home. The~     efficacy and safety treatment´s at home versus at hospital should be similar and quality of~     life should be better. Our purpose is to demostrate that Low weight molecular heparin (LWMH)~     at home for PE is at least as effective and safe at home as at hospital~   "
254868|NCT00214916|"~     In a previous study, the investigators showed that tight blood glucose control with insulin~     during intensive care reduced morbidity and mortality in adult intensive care patients.~     Whether this intervention also improves prognosis of pediatric intensive care patients~     remains unknown. The current prospective, randomized, controlled study will asses the impact~     of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. On~     admission patients will be randomly assigned to either strict normalization of blood glucose~     according age adjusted values or the conventional approach, in which insulin infusion is~     initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between~     180-200 mg/dl.~   "
254869|NCT00214903|"~     The objective of the active surveillance study is to compare incidence rates of serious~     adverse events in users of all types of newly prescribed oral continuous combined HRT~     products. The primary focus is the assessment of pertinent cardiovascular outcomes (such as~     venous and arterial thromboembolism) in new HRT users for up to 8.5 years.~   "
254870|NCT00214890|"~     Once-daily nucleotide/nucleoside reverse transcriptase inhibitor (NtRTI/NRTI) combinations~     form the backbone of many regimens. Although efficacy data exists between tenofovir and the~     pyrimidine analogues (i.e. lamivudine and emtricitabine), recent clinical data suggests a~     potential interaction between tenofovir and purine analogs (i.e. abacavir and didanosine).~      Specific Aim 1: To evaluate the impact of an acyclic nucleoside phosphonate, tenofovir (TDF),~     on the intracellular metabolism of a purine nucleoside analog, abacavir (ABC), as a~     determinant of the antiviral potency of this nucleotide/nucleoside reverse transcriptase~     inhibitor (NtRTI/NRTI) combination.~        -  Hypothesis #1: ABC and TDF dosed together will have reduced antiviral activity, as~          measured by early plasma HIV RNA decay kinetics, than the drugs given alone.~        -  Hypothesis #2: ABC dosed with TDF will have reduced intracellular concentrations, as~          measured by the ratio of carbovir triphosphate (active metabolite of ABC) to~          deoxyguanosine triphosphate (endogenous nucleotide), compared to ABC given alone.~   "
254871|NCT00214877|"~     While many bipolar patients treated with mood stabilizing medications experience improvement~     in their symptoms, some continue to have ongoing difficulties with concentration and memory.~     The purpose of this study is to look at whether these symptoms can be improved by adding the~     compound methylene blue to the treatment plan of patients who are already taking lamotrigine.~      Methylene blue is an available 'over the counter medication' in Canada. It has been studied~     in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies~     done in bipolar disorder report that methylene blue has had positive effects on both~     cognition and mood. It is important to do further research in this area as we know that, for~     patients who continue to have ongoing cognitive difficulties, there is no recognized standard~     of care for bipolar patients who experience these type of deficits.~   "
254872|NCT00214864|"~     The purpose of this study is to attempt to find better tolerated doses and schedules of this~     highly effective combination chemotherapy regimen.~   "
254873|NCT00214851|"~     An open labelled trial of Kineret (anakinra) induction therapy (100mg./day) in over a four~     week period in the treatment of Familial Cold Urticaria.~      Familial Cold Urticaria (FCU) is a rare autosomal dominant condition manifesting symptoms~     triggered by exposure to cold and variable in expression. Currently there is no standard~     reliable agent available for the treatment of patients with FCU.This study will evaluate the~     efficacy of Kineret (anakinra), an interleukin 1 receptor antagonist in induction and~     maintenance therapy in patients with FCU.~   "
254874|NCT00214838|"~     The primary objectives of this study are to identify the maximum tolerated dose and to~     evaluate safety of atiprimod in patients with advanced cancer.~   "
254875|NCT00214825|"~     Specific aims for this proposal are to determine in patients with diabetes mellitus the~     effects of an aldosterone receptor antagonist on:~        1. Coronary microvascular function assessed by MRI perfusion reserve,~        2. Endothelial dysfunction assessed by brachial artery reactivity studies, and~        3. Inflammation assessed by blood measurements of c-reactive protein (CRP), monocyte~          chemoattractant protein-1 (MCP-1), and plasminogen activator inhibitor-1 (PAI-1).~   "
254876|NCT00214812|"~     This study will assess the distribution of a microbicidal gel in the vagina and confirm the~     presence of bare spots. MRIs will be done with and without the addition of the MRI contrast~     Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of~     the MRI technique.~   "
254877|NCT00214786|"~     The purpose of this study is to assess a novel approach to immunosuppression in allogenic~     pancreatic islet cell transplant recipients. In addition, the study aims to assess remote~     site islet processing with culture for pancreatic islet cell transplantation in human~     subjects.~   "
254878|NCT00214773|"~     The objectives of this program are: to further characterize the natural progression of MPS VI~     disease; to generate and disseminate information on the care and management of MPS VI~     patients to clinical and medical professionals; to provide a resource to physicians and~     patients by providing information for optimizing patient care based on aggregate data; to~     characterize the clinical response to long-term Naglazyme® (galsulfase) treatment; to further~     characterize the long-term safety of Naglazyme® treatment.~   "
254879|NCT00214760|"~     The purpose of this study is to analyse if the alignment of the stem and the number of~     complications of the new resorbable PEGT/PBT centralizer are comparable to the standard PMMA~     centralizer during the placement of an uncemented Bihapro hip prosthesis.~   "
254880|NCT00214747|"~     This study is designed to assess the distribution and spread of four different vehicle~     formulations in the vagina. In-vivo data will be obtained regarding each vehicle formulation~     at various time points after insertion of the gel into the vagina.~   "
254881|NCT00214734|"~     The primary objective of this post-authorization safety surveillance is to measure the~     incidence of adverse events that are at least possibly related to ADVATE use, in subjects~     receiving ADVATE in routine clinical practice.~   "
254882|NCT00214721|"~     Objective: The purpose of this study is to demonstrate:~      -the non-inferiority of an experimental peritoneal dialysis solution compared to a current~     solution for the management of end stage renal disease (ESRD) in peritoneal dialysis~     patients.~   "
255019|NCT00212901|"~     Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to~     recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective~     in decreasing amount of protein in urine in patients with diabetic kidney disease than high~     doses of trandolapril.~   "
254883|NCT00214708|"~     This randomised controlled trial tests whether screening people registering with general~     practices cost-effectively increases the detection of tuberculosis. The study objectives are~     to:~        1. recruit, and randomise with stratification, forty Hackney general practices to usual~          activity or screening for TB primarily during registration health checks (by practice~          nurses and GPs) and transfer-in visits for children (by health visitors)~        2. implement a screening programme comprising education, resources and clinical support for~          intervention practices using proven behaviour change strategies~        3. gather outcomes and costs~        4. build research capacity within an ELENoR Primary Care Research Team and across a Primary~          Care Trust.~      The primary outcome is the proportion of TB cases identified in primary care. The study is~     powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in~     primary care with 80% power at the 5% significance level. Secondary outcomes are rates of~     prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and~     costs. Analyses will be by intention to treat.~   "
254884|NCT00214695|"~     The purpose of this study is to evaluate the inflow pain using an experimental peritoneal~     dialysis solution compared to a current solution for the management of end stage renal~     disease (ESRD) in peritoneal dialysis (PD) patients.~   "
254885|NCT00214682|"~     The purpose of this study is to determine whether folate and vitamin B12, physical activity~     and mental health literacy can prevent depression, and folate and vitamin B12 and physical~     activity can prevent cognitive impairment in older people. Also the study aims to assess the~     benefits for older people in improving their knowledge about mental health in relation to~     depression.~   "
254886|NCT00214669|"~     People from ethnic minority groups suffer worse ill-health from asthma than those from~     majority groups. No studies have reduced emergency care for people from minority groups. We~     have developed an education programme to address barriers to improved care for south Asian~     people with asthma. The study is set in Tower Hamlets and Newham - the UK's most deprived and~     ethnically diverse boroughs. We will invite all the local GP practices to take part, and~     using a computer programme, randomised them (like tossing a coin) into two groups - a group~     receiving usual care and a group receiving our educational programme. This comprises:~        -  Education for specialist nurse and GPs and practice nurses, using our adaptation of an~          American education course, designed to improve shared-decision making, goal-setting and~          patient-clinician partnership.~        -  Lay-led 'expert-patient' education in small groups for patients, using an adaptation of~          another American course.~        -  Improved follow-up in primary care through appointment-booking by the specialist~          nurse.We will invite south Asians aged 3-65 years with asthma after A&E attendance or~          hospital admission to take part. Those registered with practices receiving the~          educational programme will see the trial specialist nurse in a nurse-run clinic, where~          the nurse:~             1. provides self-management advice and a treatment plan,~             2. makes a follow-up appointment in primary care~             3. makes an appointment for lay-led 'expert-patient' sessions.Patients registered with~               'usual care' practices receive usual care.~      We will decide if our education programme works by comparing the number of emergency visits~     to GPs and hospital between the two groups.~   "
254887|NCT00214656|"~     Aims and Hypotheses:~      This randomised placebo controlled study will test the hypothesis that Recombinant Activated~     Factor VII (rVIIa) will improve haemostasis after an inadequate response to conventional~     therapy in complex cardiac surgery.~      Major bleeding is still of concern in complex cardiac surgery. It has been shown to be~     associated with poorer patient outcome and results in the consumption of resources (hospital~     costs, manpower and blood bank reserves). This study has the potential to provide evidence~     that rVIIa can reduce transfusion requirements and improve patient outcome in a problematic~     aspect of complicated cardiac surgery.~      The objective is to conduct a multi-centre randomised placebo controlled study that has been~     designed to scientifically evaluate the treatment of post bypass coagulopathy in the~     association with complex cardiac surgery. The trial design is based on clinical practice that~     has evolved over 2 years at the Austin Hospital during which 38 patients have received open~     label administration of rVIIa. There is currently no published RCT in this area and there is~     no TGA approval for the use of rVIIa for this indication.~   "
254888|NCT00214643|"~     There is a necessity for the development of new malaria drugs. Some antibiotics are also~     effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be~     effective against malaria, although it cannot achieve a total cure in all patients. Previous~     small studies have shown that in combination with clindamycin, an commonly used antibiotic,~     it is highly effective and safe when given for three days, leading to a total cure in most~     patients. The current study will evaluate its efficacy in a larger population in Gabon, and~     compare its effect with the generally used drug, sulfadoxine-pyrimethamine.~   "
254889|NCT00214630|"~     Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes~   "
254890|NCT00214617|"~     The objective of this research is to understand how Crestor can effectively reduce the levels~     of the bad cholesterol, LDL, in blood. It is hypothesized that with a low dose, Crestor will~     facilitate the rate of removal of LDL from the blood. At the higher dose, the increased~     potency of Crestor is explained by a reduction in the production of LDL by the liver.~   "
254891|NCT00214604|"~     Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in~     subjects with dysbetalipoproteinemia.~   "
254892|NCT00214591|"~     This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled~     (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled~     on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week~     placebo single blind run in period followed by a 52-week a double blind treatment period and~     a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or~     highest tolerable dose during the first 12 weeks.~   "
254893|NCT00214578|"~     The purpose of this study is to determine whether six months treatment with the antipsychotic~     medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism~   "
255020|NCT00212888|"~     The purpose of this study is to determine if vaccination before a structured treatment~     interruption (STI) is associated with an improvement in immune function, resulting in a~     delayed and reduced rebound in the amount of HIV virus in the blood.~   "
254894|NCT00214565|"~     This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone)~     study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately~     controlled on diet and lifestyle advice alone during the run-in period. The study comprises a~     3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week~     double blind treatment period and a 3-week follow-up period.~   "
254895|NCT00214552|"~     The hypothesis for this study is that potent anti-secretory therapy with high dose PPI~     improves asthma control regardless of either asthma severity or the presence of GERD~     symptoms.~   "
254896|NCT00214539|"~     The purpose of this study is to evaluate the safety and efficacy of the Alair System for the~     treatment of severe refractory asthma.~      This will be a multicenter, randomized controlled study comparing the effects of treatment~     with the Alair System to standard drug therapy in patients with severe asthma refractory to~     standard medication therapy. A total of 30 subjects will be randomized 1:1 to the Alair Group~     (Medical management + Alair Treatment) OR the Control Group (Medical management only).~   "
254897|NCT00214526|"~     The purpose of this study is to demonstrate the effectiveness and safety of the Alair System~     for the treatment of asthma.~      This will be a multicenter, randomized controlled study comparing the effects of treatment~     with the Alair System to standard drug therapy. One-hundred and ten subjects will be~     randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control~     Group (Medical management only).~   "
254898|NCT00214513|"~     The aim of the study is to determine whether a low-cost home-based training programme can~     maintain the achieved effect of physical training on exercise capacity and QOL in patients~     with Chronic Heart Failure.~   "
254899|NCT00214500|"~     The purpose of this study is to determine whether AT1001 (migalastat hydrochloride) is safe~     and effective in patients with Fabry disease.~   "
254900|NCT00214487|"~     The purpose of this study is to determine whether bifocal soft contact lenses are effective~     in controlling the progression of myopia in children and adolescents that exhibit a tendency~     to excessively cross their eyes while reading (esophoria or eso fixation disparity). Several~     studies have demonstrated that bifocal or progressive multifocal spectacles are effective in~     slowing the progression of myopia in children either with near point esophoria and/or with~     inadequate focusing at near. A prominent theory for one cause of myopia progression is that~     poorly focused images on the back of the eye (retina) cause the eye to lengthen, causing an~     increase in myopia. Bifocal contact lenses may reduce this retinal defocus, reducing the~     stimulus to eye elongation, and thus may reduce myopia progression.~   "
254901|NCT00214474|"~     The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm~     randomized controlled trial to explore contextual factors at the patient, clinician, and~     organizational level of two patient self-management support strategies. A communication~     technology-based intervention (automated telephone diabetes management) and an~     interpersonally-oriented intervention (group medical visits)will be compared to usual care~     for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net~     health centers in the University of California, San Francisco (UCSF) Collaborative Research~     Network.~   "
254902|NCT00214461|"~     The purpose of this study is to determine the safety and tolerability of a modified C.~     difficile vaccine at 3 dose levels compared with a placebo control administered via~     intramuscular injection in healthy elderly subjects aged > or = 65 years. This is the~     companion study to H-030-008, in which healthy younger adults have already been dosed.~   "
254903|NCT00214448|"~     The objective of this study is to validate the performance characteristics of the GeneTrait~     CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.~   "
254904|NCT00214435|"~     Poor compliance is thought to be a major cause of treatment failure. The TEddI study is a~     randomised, multi-centre, open-label study in well-controlled treatment-experienced~     HIV-infected patients to assess compliance with a once-daily regimen of antiretroviral~     therapy versus continuation of current anti-retroviral regimen delivered at least twice~     daily.~   "
254905|NCT00214422|"~     BACKGROUND:~      -This study represents a progression from findings in four previous NCI ROB protocols~     (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to~     develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue~     in prostate cancer patients.~      OBJECTIVES:~      -The primary objective of the first portion of this study is to assess the feasibility of~     using IMRT to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope~     optimize this technique with experience.~      ELIGIBILITY:~      -This is a study of image guided, targeted radiation therapy in patients with high risk of~     nodal metastases from prostate cancer. Patients with prostate cancer who have more than 15%~     risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this~     study.~      DESIGN:~        -  On the first 10 patients, we will perform approximately 5CT simulations throughout the~          course of their therapy. On each simulation, the initial treatment plan will be re-run.~          The dose-volume data from target and normal tissues will then be re-analyzed. From this~          analysis we will be better able to determine the size of margins needed to account for~          organ motion and changes such as varying amounts of gas in the bowel and fluid in the~          bladder. To the best of our knowledge, no such analyses have been published.~        -  If the initial part of this trial is feasible, we will proceed to a phase I dose~          escalation trial of radiation to the at-risk lymph nodes. The primary statistical~          objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose~          (MTD) of external beam radiation based on evaluating acute toxicity. The study will be~          conducted with a dose-escalation design with 3 patients in each dose cohort. If fewer~          than 2 of 3 patients experience an acute DLT than patients will be accrued to the next~          dose cohort. If 2 or more of 3 patients experience a DLT then the MTD will be exceeded~          and the prior, lower dose cohort will be considered the MTD. Secondary objectives of~          this study are to relate patterns in gene and protein expression to response and~          toxicity and to evaluate the frequency of late term toxicity.~        -  Specific procedures and risks will be described in a separate consent to be obtained at~          the time of biopsy. Tissue samples will be processed for cDNA microarray testing and~          stored for future analysis in the Radiation Oncology Branch, NCI.~        -  Anatomic Magnetic Resonance Imaging (MRI) and MR biological images of the prostate and~          pelvis will be obtained and tissue will be acquired with biopsy locations precisely~          translated (co-registered) to an MR image of reference. A fiducial marker (gold seed)~          will be left at the biopsy site as a fiducial marker to direct future radiation therapy~          to the prostate. If necessary, additional fiducial markers will be placed for prostate~          localization during treatment.~   "
254906|NCT00214383|"~     The original and primary aim of this study is to evaluate the effects of CHESS with Nurse~     Case Management on asthma control (symptom-free days), and adherence factors of children aged~     4-12. The investigators have expanded the scope of the specific aims. The criteria for their~     expanded aim is to also interview low-income African-American caregivers to gain an~     understanding of how they conceptualize their child's asthma, and what they consider to be~     barriers or facilitators to managing their child's asthma. There is no change in the~     investigators' original aim.~   "
255038|NCT00212654|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in postoperative~     supraventricular tachyarrhythmias.~   "
254907|NCT00214370|"~     The hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in~     children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation~     alone. Secondary hypotheses state that propofol-fentanyl sedation results in a better~     sedation induction, recovery profile and is preferred by patients/families. The study is a~     double blind, randomized, placebo controlled crossover study. Following the induction phase~     of chemotherapy, children will be randomized in a crossover manner to receive either~     fentanyl-propofol or propofol-placebo for future lumbar punctures. Patients will be studied~     on two separate occasions, once with propofol-placebo (normal saline) and once with~     propofol-fentanyl. Children will be monitored continuously by pulse oximetry,~     electrocardiogram (ECG) and direct nursing and physician observation during the sedation in~     accordance with the University of Wisconsin (UW) Pediatric Policy and Procedure. Propofol~     will be titrated to a Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score of ≤ 7~     for all children. Oxygen saturation, respiratory rate, heart rate and blood pressure will be~     recorded every 3 minutes by a study investigator during sedation.~   "
254908|NCT00214357|"~     The primary research objective is to investigate psychological, behavioral, and physiological~     changes in school staff as a result of undergoing meditation and stress reduction training.~     Specifically, we hypothesize that school staff undergoing meditation and stress reduction~     training will show decreased emotional distress on self-report measures, increased sustained~     attention on a behavioral task, and decreased stress levels as indexed by salivary cortisol.~   "
254909|NCT00214344|"~     Using the self-regulation theory, an intervention to prepare families for that experience was~     developed. This study will assess the impact of the intervention on a family's evaluation of~     their preparation and their short-term coping. The site used for this study will be the~     Trauma and Life Support Center (TLC), University of Wisconsin (UW) Hospital. After a decision~     has been made to withdraw life support, a member of the TLC staff will approach the next of~     kin of the patient to inform him/her about the study and inquire about his/her interest to~     participate. Using an experimental design, 10 family members will be assigned to the control~     group and 10 to the intervention group. Upon agreement, a research nurse will use a coin~     toss method for group assignment of the subjects until there are ten in each group.~     Experimental group subjects will receive the intervention after the family meeting.~     Demographics of the next of kin will be collected at this time. Patient information such as~     demographics, diagnosis, and time of withdrawal and death will be collected too. Two to four~     weeks after death, a telephone interview will be conducted with the next of kin using the~     Evaluation of the Experience of Withdrawal questionnaire and the Profile of Mood State -~     shortened version.~      Potential benefits are that the families will be prepared for the experience of the dying~     patient, which will help them cope better during withdrawal and after their loss. There are~     no major risks to the subjects but there might be an increase in psychological distress.~   "
254910|NCT00214331|"~     This protocol is a prospective, open-label, multicenter, population pharmacokinetic and~     pharmacodynamic study of selected anti-infective agents in pregnant women being treated for~     suspected or documented infections.~   "
254911|NCT00214318|"~     We hypothesize that b2 adrenergic polymorphisms affect b-receptor selectivity in patients~     with heart failure treated with either a b1-selective or a b-nonselective agent. b-2~     polymorphisms may contribute to differing responses to drug treatment with beta-blockers in~     heart failure. Characterizing these polymorphisms may help explain the variability in the~     degree of selectivity of action of b-blockers at the b receptor, namely if their action is~     specific for the b-1 or b-2 receptor. Part A was conducted at the University of Utah, and all~     subjects completed study related activities. Part B (sub-study) consists of genotyping of~     blood samples collected in part A, which will be completed at the University of Wisconsin.~     Sub-study (samples and DNA isolation) or Part B entailed analyzing an extra 10 mL of blood~     that was taken for DNA isolation. Genotyping (i.e. determination of genetic makeup) of beta~     adrenergic polymorphisms utilized polymerase chain reaction followed by pyrosequencing.~   "
254912|NCT00214305|"~     Treatment for head and neck cancer often results in significant swallowing problems because~     of reduced range of motion (ROM) of the larynx, tongue base, and pharyngeal walls. Our~     question is: Is swallowing therapy to improve ROM during swallowing maneuvers efficacious in~     patients with reduced ROM?~   "
254913|NCT00214292|"~     This study will apply optical spectroscopy to intraoperative margin assessment during surgery~     for breast cancer. We hypothesize that a combination of fluorescence spectroscopy and diffuse~     reflectance spectroscopy will reliably detect involved surgical margins. Twenty patients with~     ductal carcinoma in-situ will undergo a standard lumpectomy followed by scanning with a~     sterile optical spectroscopy probe. Frozen sections from the surgical cavity will be used to~     evaluate the margins. Optical spectroscopy data will be categorized as benign or malignant~     using a statistical algorithm and the results will be compared with the frozen and permanent~     section results.~   "
254914|NCT00214279|"~     Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant~     recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and~     MMF), while carefully monitoring their graft function. 25 subjects would serve as control~     patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and~     MMF). Immunologic status will be determined before and after IS withdrawal using a~     delayed-type hypersensitivity (DTH) transfer test previously described in the original~     submission. Both the steroid withdrawal subjects and the control subjects will undergo the~     DTH testing throughout the 3 years of study participation.~   "
254915|NCT00214266|"~     The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will~     obviate the need for long-term calcineurin inhibitors in renal transplantation. Most~     successful strategies to date have relied on the use of either tacrolimus or cyclosporine.~     However, the advantage of a calcineurin inhibitor free regimen may include improved renal~     allograft function, a lower incidence of hypertension, diabetes, and less drug related side~     effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant~     patients.~   "
254984|NCT00213356|"~     Anal incontinence and constipation are frequently observed in patients with neurological~     disease. The purpose of this study is to evaluate the neurological control of the anal~     sphincter in healthy subjects, patients with neurological disease by a new~     electrophysiological technique. This technique consists in recordings of anal sphincter~     responses after magnetic stimulations of the cortex and the sacral nerves.~   "
254916|NCT00214253|"~     Our hypothesis is that a successful clinical islet transplant program can be established at~     the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based~     immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following~     research questions: 1) will treatment of islet transplant recipients with thiazolidinediones~     (i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets~     necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are~     optimal candidates for islet transplantation (i.e. islet transplant alone or islet after~     kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and~     not used for pancreas transplantation be used for islet transplantation?~   "
254917|NCT00214240|"~     This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more~     effective in reducing the CMV viral load over time, as compared to standard treatment with IV~     ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load~     weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®.~     Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will~     occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until~     the CMV infection is no longer detectable, whichever is longer duration.~   "
254918|NCT00214227|"~     The purpose of this study is to compare the baseline incidence of variant alleles in the ATM~     and/or other DNA repair genes present in the Native American population versus the non-Native~     American population. It is thought that a higher baseline incidence of the variant alleles in~     the ATM gene may correlate to higher rates and higher grades of radiation toxicities noted in~     the Native American population.~   "
254919|NCT00214214|"~     The rationale for the study is to determine if Campath-1H can be used in patients recently~     diagnosed with type I DM, to induce a state of immunological unresponsiveness such that~     subjects can safely preserve beta cell mass and eliminate or lower insulin requirements,~     preserving excellent metabolic control.~   "
254920|NCT00214201|"~     The purpose of this study is to determine whether Campath-1H induction therapy and the~     associated lymphocyte depletion will permit long-term, rejection free renal allograft~     function in the absence of maintenance calcineurin inhibitor (CI) therapy.~   "
254921|NCT00214175|"~     The primary objective is to evaluate and quantify the reproducibility of functional magnetic~     resonance imaging (fMRI) maps of the eloquent brain areas corresponding to specific~     neurological functions based on activation maps obtained with different thresholds in~     patients with benign and biopsy proven low-grade brain neoplasms. Another objective is to~     access the impairment in neurological function in image guided intracranial radiotherapy~     using neurocognitive assessment tools and to derive dose response curves relating the~     impairment in a particular neurological function to the FED received by the area of eloquent~     brain corresponding to it.~   "
254922|NCT00214162|"~     Web-Based Support for Informal Caregivers in Cancer Brief Summary (including hypothesis):~      Informal caregivers need information, skills and emotional support to address physical,~     spiritual, and emotional needs associated with chronic illnesses including late stage cancer.~     Unfortunately, current conditions force clinicians to reduce their interaction time with~     patients and informal caregivers. Complimentary methods must be developed to provide needed~     information and support to caregivers. The proposed research will measure and explain the~     impact of two computer-based support systems that meet caregiver needs and facilitate~     information exchange with clinicians. The system, CHESS (Comprehensive Health Enhancement~     Support System) is a non-commercial computer system that provides patients with disease~     specific information, emotional support and skill building tools. In the expanded form to be~     tested in this study, CHESS with Caregiver Support (CGCHESS) will also provide the caregiver~     with more information, support and skills training related to palliative care. CGCHESS will~     be further enhanced to communicate essential patient and caregiver information to clinicians~     prior to a scheduled clinic visit and when patient symptoms exceed a threshold.~      The investigators' primary hypothesis is that CGCHESS + Clinician Report (CR) will reduce~     caregiver burden more than CGCHESS because of the additional support caregivers and patients~     receive from clinicians who have access to the CHESS clinician report. Secondary analyses~     will study the mechanisms of the CHESS effect. Specifically the investigators anticipate that~     the CHESS effect on caregivers will be mediated by the CHESS effect on interaction patterns~     with clinicians, satisfaction with clinical visits and by the CHESS effect on four patient~     outcomes (quality of life, negative affect, average severity of nine common late-stage~     cancers).~   "
254923|NCT00214149|"~     Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women~     with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ~     (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted~     treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole~     breast. The purpose of this study is to determine if an acceptable outcome can be achieved~     with radiation delivered only to the region of the tumor bed. If this is true, partial breast~     irradiation may lend itself to much shorter treatment times (one week) and the toxicities to~     adjacent normal structures (heart, lung, chest wall) will be greatly reduced.~   "
254924|NCT00214136|"~     The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to~     escalate the biologically effective dose to the pelvic lymph nodes in a short course of~     radiation therapy. An increased total and biologically effective dose will be delivered to~     the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard short~     course IMRT of radiation (70 Gy at 2.5 Gy/fraction).~   "
254925|NCT00214123|"~     The purpose of this trial is to pilot reducing the duration of radiation treatment for lung~     cancer patients from 6 to 5 weeks using tomotherapy. Specific patient doses will be based on~     tumor volume being treated. Modeling has shown that increased biologically effective dose~     (BED) to tumors can be achieved by shortening the radiation delivery schedule and increasing~     the dose per fraction. This requires decreasing the total dose to hold lung toxicity constant~     at each dose per fraction level. This is a major paradigm shift in the treatment in this~     disease and is projected to result in significant improvements in patient outcome as well as~     a substantial cost savings.~   "
254926|NCT00214110|"~     This is a single-center, phase 2 randomized clinical trial of tamoxifen on mean percent~     predicted isometric muscle strength in patients with amyotrophic lateral sclerosis (ALS). The~     purpose is to determine whether the triphenylethylenetamoxifen, used as adjuvant therapy in~     the treatment of breast cancer, can delay the loss of isometric muscle strength in ALS~     patients.~   "
254985|NCT00213343|"~     the purpose of this study is to compare the oesophageal depression induced by bilateral~     phrenic nerve stimulation during swallowing in patients with neurological laryngeal~     aspiration~   "
255039|NCT00212641|"~     The objectives of this study are to characterize the pharmacodynamic profile, safety and~     tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus~   "
255040|NCT00212628|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with~     involutional osteoporosis.~   "
254927|NCT00214097|"~     The purpose of this study is to examine the clinical feasibility of using IMRT combined with~     daily pretreatment prostate localization to deliver increasingly hypofractionated treatment~     courses. Progressively larger fraction sizes will be delivered in a phase I design based on~     both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design~     utilizes schemas that maintain an isoeffective dose for late effects, while predicting that~     tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if~     proven effective and safe, would result in significant cost saving and more efficient use of~     resources.~   "
254928|NCT00214084|"~     Obstructive sleep apnea (OSA) is a medical problem whose importance is increasing in~     recognition and awareness. The National Commission on Sleep Disorders estimates that 15~     million Americans have OSA, many of whom remain undiagnosed (24). OSA is associated with the~     development of hypertension and other cardiovascular diseases (1,2). Patients with OSA, like~     those with congestive heart failure, hypertension, hypercholesterolemia and diabetes, exhibit~     impaired EDV (25-32). OSA is also associated with impairments in endothelium-dependent~     cerebral blood flow responses, which may be a risk factor for stroke (33). Impaired EDV is a~     result of reduced production or inadequate action of nitric oxide. Since EDV worsens with~     disease progression and improves with disease treatment, it serves as a prognostic marker of~     vascular function (34-37). In OSA, hypoxia and neurohumoral disturbances increase generation~     of reactive oxygen species (ROS) that neutralize nitric oxide and impair~     endothelium-dependent responses (9,10,38). One source of ROS in endothelial cells is the~     enzyme xanthine oxidase (38). XO is an enzyme present in the vascular endothelium that~     significantly contributes to generation of ROS in congestive heart failure,~     hypercholesterolemia and diabetes (13-17). Inhibition of XO improves endothelium-dependent~     resistance vessel responses in these populations (13-17), but it is unknown if XO~     significantly contributes to oxidative stress and endothelial dysfunction in OSA. The central~     hypothesis of this application is that inhibition of XO with allopurinol will reduce~     oxidative stress and generation of ROS, thereby improving nitric oxide bioavailability and~     EDV in OSA. Our hypothesis has been formulated on the basis that patients with OSA experience~     repeated hypoxemia that increases activity of XO and other enzymes, thus increasing the~     generation of ROS that negatively impact EDV. Hypoxia is detrimental to vascular homeostasis~     since it increases generation of ROS through direct mechanisms and via activation of XO.~   "
254929|NCT00214071|"~     Obstructive sleep apnea (OSA) is a medical problem whose importance is increasing in~     recognition and awareness. OSA is associated with the development of hypertension and other~     cardiovascular diseases (1,2). OSA has pathophysiologic characteristics that are known to~     negatively impact immune function. Both sleep deprivation and hypoxia, hallmarks of OSA,~     impair immune responses (6,8,11). In addition, patients with OSA are frequently obese and~     obesity may be associated with increased chance of infections and immune impairment (14,15).~     Adipose cells are known to secrete cytokines and hormones that are involved in the immune~     response such as leptin, tumor necrosis factor alpha and interleukin-6 (16-19). Thus, it~     seems very likely that OSA may impact antigen-specific immune responses. Although it is known~     that characteristics of OSA impact immune function, it is not known what effects clinical OSA~     has on immunity.~      The central hypothesis of this application is that that patients with obstructive sleep apnea~     will have attenuated cell-mediated and humoral immune responses to influenza vaccine compared~     to matched control subjects. Our hypothesis has been formulated on the basis that patients~     with OSA are sleep deprived and experience repeated hypoxemia that negatively impact both~     humoral and cell-mediated immune responses.~   "
254930|NCT00214058|"~     The purpose of this study is to determine the safety and efficacy of this regimen in women~     with ovarian or peritoneal cancer~   "
254931|NCT00214045|"~     The study will help define the best tolerated approach to cystoscopy in women by randomly~     comparing flexible to rigid cystoscopy. Previous randomized studies evaluated rigid~     cystoscopy under general anesthesia versus flexible cystoscopy under local anesthesia. As a~     result of these studies, flexible cystoscopy is performed in the clinic setting generally in~     males. However, many women have rigid cystoscopy performed in the clinic while the men have~     flexible cystoscopy. No studies to date have evaluated whether flexible cystoscopy is better~     tolerated in women compared to rigid cystoscopy in women in the clinic setting.~   "
254932|NCT00214032|"~     The objectives of this study are to evaluate the effectiveness of Pycnogenol (French maritime~     pine bark extract) for arm lymphedema in women following treatment for breast cancer, to~     evaluate the accuracy and sensitivity of bioelectric impedence as a measurement of lymphedema~     of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.~   "
254933|NCT00214019|"~     This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or~     the combination treatment with fluticasone and salmeterol, is associated with a greater~     number of sputum eosinophils following antigen challenge and, under these circumstances, the~     migrating peripheral blood eosinophils are less adherent.~   "
254934|NCT00214006|"~     First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the~     genetic and environmental variables that cause those plaques to become symptomatic. Second,~     to differentiate between vulnerable plaque and other types of plaque using ultrasound~     elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of~     back-scattered ultrasonic echoes.~   "
254935|NCT00213993|"~     The objectives of this study are to evaluate the effectiveness of an antiperspirant in~     preventing or attenuating the severity of palmer-plantar erythrodysesthesia associated with~     the Food and Drug Administration (FDA)-approved doses of capecitabine. The hypothesis is that~     cytotoxic compounds in sweat will be prevented from being deposited in the skin and causing~     chronic toxicity.~   "
254936|NCT00213980|"~     This is a two arm, double-blind randomized study looking at the effect of zoledronate, a~     bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.~   "
254937|NCT00213967|"~     This study will determine whether decreasing pain associated with intramuscular injection by~     decreasing needle temperature could be an inexpensive, simple way to decrease injection fear~     and increase immunization rates.~   "
254938|NCT00213954|"~     Nerve block anaesthesia is wildly practised in France, avoiding general anaesthesia in a~     number of cases and producing excellent post-operative analgesia in trauma and orthopaedic~     surgeries. Even realised by experimented anaesthetists, 5-15% of failures and rare~     complications (such as vascular puncture, paresthesia, systemic local anaesthetic toxicity,~     epidural and spinal anaesthesia, neuropathy) are noticed. The aim of the study is the~     evaluation of an ultrasound-guidance technique in the four predetermined blocks and the~     incidence of their complications.~   "
255062|NCT00212316|"~     The purpose of this study is to evaluate the safety, tolerability and clinical impact of~     15-grams daily of sodium phenylbutyrate (phenylbutyrate) in Huntington's disease and to lay~     the groundwork for possible subsequent trials designed to specifically address its ability to~     slow or halt the progression of the disease.~   "
254939|NCT00213941|"~     Transient tachypnoea of the newborn (TTN) is a common cause of hospitalisation in the~     neonatal period, complicating 1 to 1,5 per cent life birth. Predisposing factors are~     prematurity, birth after C section, especially before the onset of labor. The main factor~     leading to this condition is a lack of absorption of the fluid contained in the alveolar~     space resulting in an early respiratory distress which normally resolves in two to five days~     with oxygen supplementation.~      Meanwhile, some neonates will experience a complicated evolution requiring ventilatory~     support and hospitalisatioon in neonatal intensive care unit. This complication is not~     preventable and could result either of a surfactant deficiency (primary or secondary) or a~     persistent pulmonary hypertension of the neonate (PPHN).~      In this study, a cohort of newborn presenting TTN will be followed, in order to evaluate, at~     initial admission, pulmonary maturation (with fetal lung maturity test and the stable~     microbubble test) and to seek for PPHN (echochardiography). Therapeutic management will be~     done according to standard care and classification of the neonate will be performed according~     to their clinical evolution: group 1 (uncomplicated TTN) and group 2 (complicated TTN).~      Statistical analysis will compare results of the tests at initial evaluation in the two~     groups, and accuracy of the tests to predict a complicated evolution will be established.~   "
254940|NCT00213928|"~     To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed~     Extract~   "
254941|NCT00213915|"~     -  exercise capacities are still altered after heart transplantation partly due to~          peripheral endothelial dysfunction~        -  cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and~          can be reversed in an animal model by L-arginine supplementation~        -  to determine the potential beneficial effect of L-arginine supplementation on exercise~          capacity and renal function of heart transplant recipients~   "
254942|NCT00213902|"~     The objectives of this study are:~        1. To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac~          remodeling and to improve hemodynamics in diastolic heart failure (DHF).~        2. To evaluate the effect of clonidine on neurohormones and quality of life in patients~          with DHF.~      The study is a double-blind, placebo-controlled study evaluating the effects of clonidine~     compared to placebo in patients with DHF. A total of 70 patients with DHF will be randomized~     in a 1:1 ratio to:~        1. placebo (n=35) or to~        2. clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by~          uptitration to 0.150 mg twice a day for 6 months.~      The primary outcome is the reversion of cardiac remodeling and hemodynamic parameters~     evaluated by magnetic resonance imaging (MRI) and echocardiography.~   "
254943|NCT00213889|"~     This study uses a sequence analysis for TWIST and other craniofacial development genes, among~     patients presenting with facial clefting.~   "
254944|NCT00213876|"~     At present, diagnosis of oligodendroglioma is made on histological and radiographic criteria~     in the French Mayo-Ste Anne classification. The less frequent grade A oligodendrogliomas are~     characterized by no vascular contrast on RMN evaluation comparatively to grade B forms. This~     benign histological subtype relapses in few cases with a more aggressive histology. To~     determine these relapsed cases at diagnosis, a collection of tumour begun in February 2004.~     Then, our study was designed to identify diagnostic molecular and metabolic markers that~     could eventually be used as a signature characterising grade A versus grade B~     oligodendrogliomas. The molecular analysis will use genomic techniques like allelotyping~     study, quantitative real-time PCR, gene sequencing , serial analysis of genomic expression~     and immunohistochemistry, since the metabolic study will be the spectroscopic examination of~     in vivo tumour. This study will include paediatric and adult patients followed for~     oligodendrogliomas, medulloblastomas and gliomas to compare the different tumour signatures.~     All these results will be correlated to survival and clinical features.~   "
254945|NCT00213863|"~     This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to~     adjust the quality of the voice under local or general anesthesia. The aim is to restore~     phonation using a porous titanium prosthesis in laryngeal surgery.~   "
254946|NCT00213850|"~     The purpose is to obtain reference values of respiratory resistance (a technique widely used~     in children), in adults. The interest is that this technique needs only little co-operation~     and would be particularly adapted in subjects in whom co-operation is insufficient for other~     measurements.~   "
254947|NCT00213837|"~     This trial will study the reconstruction of the anterior part of the mandible and the~     adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or~     not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free~     microanastomosed bone flaps that are often associated with important morbidity.~      The implant is consolidated by two prolonged parallel plates of titanium, allowing their~     fixation to the bone, easy to fix in a short time.~   "
254948|NCT00213824|"~     This is a study of the expression of nogo and reticulon genes in the skeletal muscle of~     patients with amyotrophic lateral sclerosis (ALS).~   "
254949|NCT00213811|"~     This study is based on the study of the natural history of a rare disorder: the Bardet-Biedl~     syndrome (BBS) (which is associated with retinitis pigmentosa, polydactyly, cognitive~     impairment, obesity, and kidney failure). The clinical, biological, and radiological features~     of adult patients are studied. In parallel, a molecular study is performed on the known genes~     to date (8 genes from BBS1 to BBS8) and to identify new genes involved. The parts of the~     study are combined in a phenotype-genotype correlation study.~   "
254950|NCT00213798|"~     The majority of lung cancer patients have a tumor-derived genetic alteration in circulating~     plasma DNA that could be exploited as a diagnostic tool. The aim of this study is to evaluate~     if plasma DNA can be used as a valuable non invasive test to monitor disease progression~     without assessing the tumor.~   "
254951|NCT00213785|"~     A study of plasmatic concentrations of endothelin-1 (ET1), atrial natriuretic peptide (ANP)~     and brain natriuretic peptide (BNP) in acute ischemic stroke.~   "
254952|NCT00213772|"~     Comparison of patients with documented PCT and HCV infection, documented PCT without HCV, HCV~     infection without PCT and controls without HCV or PCT.~      Single blood + urine sample uptake to investigate : mutations in HFE gene, uroporphyrinogen~     decarboxylase activity, HCV genotye, history of disease.~   "
254953|NCT00213759|"~     Prevention trial of nosocomial infections in neutropenic prematures with G-CSF~   "
254954|NCT00213746|"~     Viability assessment remains a clinical challenge in patient with coronary artery disease and~     left ventricular dysfunction. Several imaging modalities are available for evaluating~     myocardial viability, based either on perfusion or on contractile reserve analysis. Briefly,~     perfusion analysis is highly sensitive and contractile reserve highly specific. A combined~     analysis of both perfusion and contractile reserve has been proposed to improve the~     diagnostic accuracy in patient referred for a revascularization procedure. However, the value~     of this combined analysis has not been validated in unselected patients referred for~     viability assessment.~      The patients enrolled in the study will undergo a nitrate enhanced rest gated SPECT using a~     Tc-99m labeled tracer (sestamibi or tetrofosmine) followed by a second gated SPECT acquired~     during a low-dose dobutamine infusion (10 mcg/kg/mn). All patients will have a 6-month~     clinical and imaging follow-up, including physical examination and a nitrate enhanced rest~     gated SPECT using the same radiopharmaceutical. All treatments received during this 6-month~     period will be recorded, including medical therapy and coronary revascularization~     (angioplasty, stenting and CABG).~      Finally, the value of baseline perfusion and contractile reserve analysis in predicting left~     ventricular ejection fraction changes at 6-month follow-up will be evaluated.~   "
254955|NCT00213733|"~     This is a prospective study of surgically resected samples and lymph nodes of lung cancer~     patients. For histopathologically positive lymph nodes from a complete resection, the~     investigators would like to analyse tumor tissue by allelotyping and comparing these results~     with those observed in the primary lung tumor to establish a cartography of molecular~     alteration in resected lung cancer. For non histopathologically positive lymph nodes, the~     investigators would like to research the presence (or not) of micrometastasis by~     allele-specific PCR (polymerase chain reaction).~   "
254956|NCT00213720|"~     Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate~     of atrial fibrillation, the main complication of this condition.~   "
254957|NCT00213707|"~     Re-infection of the liver graft occurs universally following liver transplantation for~     HCV-induced end stage liver disease. Interestingly, the manifestation of HCV infection~     ranging from an asymptomatic carrier state to rapid progression to liver cirrhosis is~     extremely variable from one patient to another. The host and viral factors being responsible~     for the different course of HCV infection are poorly understood. Our study will focus on~     dendritic cells which are known to play a critical role in the control of viral infection.~     Viral factors (quasispecies evolution) will also be analysed and Th1 Th2 cytokines produced~     in the serum evaluated.Thirty liver transplanted patients will be included : 20 patients~     transplanted for HCV-related disease and 10 controls transplanted for non HCV-related~     disease. Blood samples will be taken just before transplantation and at different time~     -points up to 5 years after transplantation. Function of blood monocyte-derived DC will be~     evaluated. Circulating blood plasmacytoid (pDC) and myeloid DC (mDC) sub-populations will be~     enumerated. HCV quasispecies evolution will be analysed. This study may help to define~     prognostic markers on progression of hepatitis C in liver transplantation and allow the~     development of new immunotherapeutic drugs~   "
254958|NCT00213694|"~     Clinical response to chemotherapy. Biological parameter (PSA) and RECIST evaluation.~     Association of Docetaxel (J 15) and Celecoxib.~   "
254959|NCT00213681|"~     To evaluate whether bilevel positive airway pressure more rapidly improves ventilation than~     continuous positive airway pressure (CPAP) in patients with acute pulmonary edema. CPAP is~     delivered via a simple device connected to oxygen.~   "
254960|NCT00213668|"~     This study investigates the effects of enterally supplied glutamine on gastric emptying,~     intestinal transit, age of total enteral nutrition and age at the end of hospitalisation.~     Forty neonates, aged at least 2 days and free of acute illness participate in a prospective,~     randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched~     with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric~     emptying is analysed by sequential measure of intragastric residue by diluted polyethylene~     glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.~   "
254961|NCT00213655|"~     Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two~     randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.~   "
254962|NCT00213642|"~     Cisplatin is a heavy-metal complex widely used in the treatment of a variety of malignancies,~     including small cell and non-small cell lung cancer, ovarian, bladder, head and neck,~     esophageal, cervical and germ cell tumors. The administration of cisplatin is commonly~     associated with certain drug-induced toxicities that may limit their clinical utility and~     adversely affect the quality of life of patients undergoing treatment. Although many advances~     have been made in reducing some of the toxicities associated with platinum drug therapy, it~     is clear that dose-limiting nephrotoxicity remains a major stumbling block in the use of this~     compound. Subtle changes in renal function occur without overt renal insufficiency,~     consisting of a decrease in effective renal plasma flow and tubular dysfunction despite~     aggressive hydratation. Early tubular damage occurring within 1 to 3 hours after cisplatin~     administration has been demonstrated by measurement of urinary beta 2-microglobulin, a~     sensitive marker of tubular injury. The chronic lesion has become of greater concern in~     recent years as many patients have been cured or placed into long-term remission due to~     cisplatin treatment. It consists of a decrease in glomerular filtration rate, which is not~     necessary characterized by a remarkable increase in serum creatinine. Cumulative tubular~     damage has been demonstrated by increased urinary excretion of tubular enzymes such as~     alanine aminopeptidase and beta 2-microglobulin. In this setting, predicting the occurrence~     of chronic cisplatin-induced nephrotoxicity remains a clinical challenge.~      Tc-99m mercaptoacetyltriglycine (MAG3) is predominantly a proximal tubular secretion renal~     agent without cortical fixation indicated for dynamic renal studies to evaluate cortical~     tubular function and collecting system drainage. Tc-99m MAG3 and is the agent of choice for~     obstructive uropathy and diffuse functional abnormalities of the renal cortex. The aim of~     this study was to evaluate by means of Tc-99m MAG3 scintigraphy the acute and subacute~     impairment of tubular secretion after cisplatin administration in patients with head and neck~     cancer receiving chemotherapy.~   "
254963|NCT00213629|"~     The diagnosis of the different forms of inflammatory myopathies (polymyositis,~     dermatomyositis, inclusion-body myositis...) remains difficult which may lead to~     unappropriate patient care.~      Objective 1 : to develop and evaluate the diagnostic value of a dedicated DNA-array~     (myoARRAY) for adult-onset muscular diseases with focus on inflammatory myopathies.~      Objective 2 : to evaluate the diagnostic value of T cell repertoire (TcLand) analysis to~     distinguish different forms of inflammatory myopathies.~   "
254964|NCT00213616|"~     Bilateral laryngeal reinnervation induces a rise in laryngeal resistance and speech~     alteration. The aim of this study is to propose laryngeal reinnervation by a phrenic nerve~     root to patients with bilateral laryngeal paralysis.~   "
255111|NCT00211666|"~     This hypertension project is evaluating strategies developed to target problems underlying~     lack of blood pressure control among treated but uncontrolled hypertensive patients in East~     and Central Harlem.~   "
254965|NCT00213603|"~     The goal of this multicentric French randomized trial is to determine the best auto~     fluorescence bronchial endoscopic follow-up strategy in high risk patients bearing low grade~     bronchial precancerous lesions. Subjects will be randomly assigned to one of the following~     arm :~      (A) every 6 months clinical and chest Xrays follow-up without intermediate endoscopy, (B)~     every 6 months clinical and chest Xrays follow-up including repeated autofluorescence~     endoscopy and biopsies on a 6 months basis in case of low grade dysplasia or on a one year~     basis in patients without dysplasia.~      After 36 months follow-up, each patient from the two groups will be subjected to a final~     autofluorescence endoscopy and biopsy and a Spiral Chest Xray.~      The final analysis will compare between the two groups :~        1. The probability of progression from an initially identified low grade lesion to a high~          grade lesion~        2. The probability of respiratory epithelial tract progression assessed by the occurrence~          of a lung cancer or high grade lesion.~        3. The characteristics of lung cancers detected in each arm~        4. In both arm, the influence of risk factors and persistent exposure to tobacco on lesion~          evolutivity.~   "
254966|NCT00213590|"~     The purpose of the study is to show the efficacy of reduction of cyclosporine A exposure~     measured by the area under the curve by Bayesian estimator on the primary prevention of~     degradation of the renal function in renal transplant recipients~   "
254967|NCT00213577|"~     The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus~     500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic~     urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.~   "
254968|NCT00213564|"~     The objective of the study is to identify and validate predictive markers of infliximab~     responsiveness in RA patients by 2 approaches: i) measuring biochemical, immunological and~     bone markers in sera because of their involvement in pathogenic mechanisms; ii) identifying~     gene-expression signatures in PBMCs by the transcriptomic analysis.~      Patients with active RA (ACR criteria) were given i.v. 3 mg/kg infliximab associated with~     metotrexate at weeks 0, 2, 6, and every 8th week. Infliximab efficacy was evaluated at week~     14, using the EULAR response criteria.~        1. Just before the starting of infliximab treatment, the following parameters were measured~          in the sera: i) immunological tests: rheumatoid factor (IgA, IgG, IgM), anti-CCP, autoAb~          recognizing the 27 C-terminal fragment (ACAST-C27) and domain I (ACAST-DI) of~          calpastatin, anti-G6PI, anti a-enolase, anti-keratin and anti-perinuclear factor; ii)~          biochemical markers: CRP, MMP-1, MMP-3, TIMP-1, TIMP-2; markers of bone resorption:~          pyridinolin, deoxypyridinolin, osteoprotegerin, sRANKL, COMP. The predictive value of~          each parameter for a response/non-response to infliximab was analysed using Fischer's~          exact, Mann-Whitney and Chi2 tests.~        2. A blood sample was collected just before the onset of infliximab treatment and total~          RNAs were extracted from the peripheral blood mononuclear cells. The [33P] radiolabeled~          mRNAs were hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes~          spotted at a high density on nylon membranes. Data were normalized and filtered to allow~          the comparison between RNA samples. Statistical analyses were performed with the R~          software and hierarchical clustering was performed with the Cluster and Tree View~          softwares.~   "
254969|NCT00213551|"~     Gut barrier plays a major role in defence of the organism. During catabolic states, like~     major surgery or inflammation, gut barrier could be altered. It has been reported that~     preoperative nutritional support may have beneficial effects on clinical outcome in patients~     with surgery on gastrointestinal tract. Glutamine, which is a conditionally essential amino,~     have been reported to modulate inflammatory, antioxidant responses and protein metabolism in~     intestine. In addition, glutamine supply improves clinical outcome in critically ill~     patients. Antioxidant micronutrients may also have some beneficial effects in intestine by~     improving antioxidant response and might also regulate protein expression. Nevertheless,~     effects of glutamine combined to antioxidant micronutrients have not been evaluated.~      Thus, the aim of this study will be to assess the influence of glutamine and~     glutamine-antioxidant micronutrients-containing solutions on intestinal response in humans.~   "
254970|NCT00213538|"~     The objective of the study is to identify and validate predictive markers of anakinra~     responsiveness in RA patients by a transcriptomic approach.~      Patients with active RA (ACR criteria) were given subcutaneous anakinra (100mg/d) 3~     associated with metotrexate. Anakinra efficacy was evaluated at week 12, using the EULAR~     response criteria.~      A blood sample was collected just before the onset of anakinra treatment and total RNAs were~     extracted from the peripheral blood mononuclear cells. The [33P] radiolabeled mRNAs were~     hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes spotted at a high~     density on nylon membranes. Data were normalized and filtered to allow the comparison between~     RNA samples. Statistical analyses were performed with the R software and hierarchical~     clustering was performed with the Cluster and Tree View softwares.~   "
254971|NCT00213525|"~     Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental~     factors, and particularly toxic drug exposure, in the genesis of scleroderma has been~     suggested.~      This prompted us to conduct this prospective, case-control, multicentric study, including 2~     groups of subjects:~        -  100 patients with scleroderma~        -  300 sex- and age-matched healthy controls. The aim of our study is to determine whether~          exposure to toxics is higher in patients with scleroderma compared with healthy~          controls.~   "
254972|NCT00213512|"~     to treat in an open non comparative clinical study patients presenting pemphigus with~     corticodependance, corticoresistance and contre-indication to systemic steroids.~   "
254986|NCT00213330|"~     Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or~     constipation. It is a very frequent problem. However, the exact cause of irritable bowel~     syndrome remains unknown. The purpose of this study is to look for a different cerebral~     response by magnetic resonance imaging after rectal stimulation in patients with irritable~     bowel syndrome compared to healthy subjects and to patients with digestive organic disease.~     Our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of~     visceral stimulation.~   "
254987|NCT00213317|"~     The purpose of this study is to evaluate the effect of sacral nerve magnetic stimulation on~     the colonic motility in healthy subjects, in incontinent and constipated patients.~   "
255112|NCT00211653|"~     The purpose of this study is to determine if Acetylcysteine is effective in preventing renal~     failure associated with cardiac surgery~   "
254973|NCT00213499|"~     The clinical efficacy of noninvasive ventilation (NIV) has now been demonstrated in the~     management of acute-on-chronic respiratory failure (ACRF) of various etiologies. Endotracheal~     mechanical ventilation (ETMV) can lead to numerous complications and weaning difficulties~     increasing the risk of prolonged ETMV, morbidity and mortality as well as excess cost of~     intensive care. Therefore, it could be interesting to use NIV for delivering effective~     ventilatory support and reduce the length of ETMV in ACRF patients still not capable to~     maintain spontaneous breathing. From the interesting but discordant results of two recent~     randomised controlled trial, a working group from the Société de Réanimation de Langue~     Française (SRLF) decided to perform a new prospective randomised controlled and multicenter~     trial. The aim of the study is to assess the usefulness of NIV as an extubation and weaning~     technique in ventilated ACRF patients. The methodology used compares three weaning strategies~     in parallel in ACRF patients considered difficult to wean : invasive conventional weaning~     (group A), extubation relayed by nasal oxygentherapy (group B), and extubation relayed by NIV~     (group C). Based on the main end-point defined as the weaning success/failure rate, 208~     patients from17 investigator centers are planned to be included. Results of the study will~     also allow to assess the respective impact of the three weaning strategies on the length of~     ETMV and weaning, the mechanical ventilation-related morbidity, the patients lengths of stay~     and mortality.~      Results of the VENISE trial should permit to improve the management of the difficult to wean~     ACRF patients and thus to contribute to more define the place of NIV among the weaning and~     prevention of re-intubation strategies in these patients.~   "
254974|NCT00213486|"~     The standard non surgical therapy of locally advanced esophageal cancer is based on a~     definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the~     alternative regimen which is being studied is the combination of a weekly cisplatin and~     irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily~     aimed to evaluate the clinical complete response rate and secondary objectives were toxicity~     profile and survival.~   "
254975|NCT00213473|"~     the aims of SACHA study was to appreciate prevalence, evolution and follow-up, treatment~     response of patients with acquired hemophilia with biological and clinical data. Inclusion~     criteria were factor VIIIc below 30% associated with presence of Facgteur VIII inhibitor~     (titer > 1 u Bethesda. Clinical and biologival data were obtained at Day 0 (as soon as~     possible and at 1, 3, 6 and 12 months.Informations were notified to co-investigators with the~     help of two french medical society (Internal medicine, french haemostasis and thrombosis~     society.~   "
254976|NCT00213460|"~     Small bowel involvement is still recognized to be associated with great morbidity and~     mortality in SSc patients, leading particularly to malabsorption and intestinal~     pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported~     to be one of the most common causes of death.~      In a previous prospective study, we have demonstrated the high prevalence of small intestinal~     involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc~     patients had upper intestinal motor disturbances. However, to date, no authors have yet~     analyzed the course of upper intestinal motor dysfunction in SSc.~      The aims of this study were therefore to assess the 5-year course of small bowel motor~     disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for~     an association between upper intestinal motor dysfunction outcome and other clinical~     manifestations of SSc.~   "
254977|NCT00213447|"~     immunological study of the T cell repertoire phenotype and functionality in hypersensitivity~     syndrome.~   "
254978|NCT00213434|"~     The purpose of this study is to determine if the mandibular advancement by Herbst device is~     effective in the treatment of moderate obstructive sleep apnea patients.~   "
254979|NCT00213421|"~     to compare efficacity and tolerance of two stratégies of dermoval application in treatment of~     bullous pemphigus.~   "
254980|NCT00213408|"~     Catheter ablation of typical atrial flutter is a well established technique with a high acute~     success rate and very low complication and recurrence rates. It has also been shown that~     ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in~     quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the~     first line therapy in patient suffering from their first symptomatic typical atrial flutter~     episode. This study is a multicenter trial in which patients with a first symptomatic episode~     of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic~     drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12~     leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following~     randomization.The primary end-point is the absence of recurrence of typical atrial flutter at~     - and 12 months of follow up. The secondary end points are the cost and the~     cost/effectiveness ratio of these two approaches.~   "
254981|NCT00213395|"~     Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute~     hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are~     determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.~      Facial masks during NIV are associated with deleterious consequences like gas leaks around~     the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask~     discomfort. In order to limit these side effects, a cephalic interface has been recently~     designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit~     pressure is therefore spread over a larger surface outside the nose area. However, this mask~     has a high volume that may interfere with NIV efficacy and may also induce claustrophobic~     sensations.~      The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask~     versus a conventional oronasal mask during AHRF.~   "
254982|NCT00213382|"~     The aims of this study are in four experimental sessions. The aims are:~        -  to characterize the excitability of the cortical pharyngeal area with pharyngeal~          pressure and electromyograms (EMGs), at rest, in awake healthy subjects;~        -  to study its facilitation by inspiration and deglutition; and~        -  to study its plasticity by respiration and swallowing.~   "
254983|NCT00213369|"~     Aspiration could induce major respiratory affection. They are often present after stroke. The~     aim of this study is to facilitate swallowing recuperation in stroke patients using~     peripheral laryngeal stimulation and to understand its mechanisms using motor evoked~     potential and cortical evoked potential.~   "
254988|NCT00213304|"~     We hypothesize that children listed to undergo solid organ transplant will experience (at the~     very most) a low rate (< 5%) of serious vaccine-related adverse events within 42 days after~     immunization with live attenuated Oka/Merck varicella vaccine (VARIVAX™). We also hypothesize~     that the immunogenicity of two doses of VARIVAX™ in the study population will be similar to~     historical data in healthy subjects and that the efficacy of two doses of the vaccine in the~     study population will be similar to that of healthy subjects.~   "
254989|NCT00213291|"~     This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given~     every 14 to 28 days to treat low red blood cells in children with chronic kidney failure.~   "
254990|NCT00213278|"~     This study is examining whether Vinblastine is an effective drug to shrink low grade glioma~     brain tumors in children, and what the side effects are.~   "
254991|NCT00213265|"~     We plan to study whether the 7-valent pneumococcal conjugate vaccine (Prevnar™) is safe and~     effective in protecting children who have had a solid organ transplantation and healthy~     children from pneumococcal infections.~      We expect that two or more doses of Prevnar™ will result in similar antibody responses among~     transplant recipients compared with healthy control subjects, and that children who have~     undergone solid organ transplant will have a similar number of serious vaccine-related~     adverse events within 7 days after Prevnar™ as the healthy patients.~   "
254992|NCT00213252|"~     The primary objective of this study is to evaluate if children with acute asthma given a~     single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast~     will achieve a therapeutic failure rate at day 8 not significantly higher than those given~     six daily doses of oral prednisolone. Secondary objectives include comparison of the two~     groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and~     days without asthma by day 8.~   "
254993|NCT00213239|"~     This study will examine whether the combination of two anaesthetic medications, propofol and~     remifentanil, is suitable for short duration surgical procedures, providing a shorter~     recovery time and fewer side effects than either drug used alone.~   "
254994|NCT00213226|"~     This study is to determine the effectiveness of five-day treatment versus a single dose of~     oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first~     episode of acute bronchiolitis presenting in the Emergency Department~   "
254995|NCT00213213|"~     This study will examine the safety and effectiveness of sugar water to relieve pain in~     newborn infants during painful blood tests and injections. Infants of diabetic mothers who~     receive repeated blood tests will be compared to infants of healthy mothers who receive~     routine painful procedures.~      We believe that administration of sucrose analgesia for every painful cutaneous procedure~     performed after delivery will result in less pain during the newborn infant screening test.~   "
254996|NCT00213200|"~     This study will test which type of pain medication is best for the management of pain in~     newborn preterm and full-term infants having a deep intravenous cannula inserted. It will~     compare the effectiveness of intravenous morphine alone, a local anaesthetic cream~     (amethocaine) alone, and both medications together. It will also determine the safety of both~     medications.~   "
254997|NCT00213187|"~     The objectives of this study are to study the effect of formal exercise training on motor~     function and overall physical fitness in children with arthritis. A 12-week comprehensive~     exercise program will be used. Formal exercise training will be compared to Qi gong.~   "
254998|NCT00213174|"~     This study will compare children's injury rates (arm fracture, head injury and other~     injuries) when playing on playground equipment on granite sand versus wood fibre playing~     surfaces.~      The hypothesis is that injury rates (arm fracture, head injury and other injuries) among~     school children are equal on granite sand and wood fibre playground surfaces.~   "
254999|NCT00213161|"~     The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving~     package of iron and other micronutrients, to treat infants with iron deficiency anemia in~     India. Results have implications for programs using Sprinkles worldwide because lower doses~     of iron may have fewer side effects.~   "
255000|NCT00213148|"~     The purpose of this study is to investigate and compare the safety and efficacy of various~     doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating~     follicular growth and ovulation in infertile women with ovulatory dysfunction.~   "
255001|NCT00213135|"~     The purpose of the study is to determine if cladribine tablets are a safe and effective~     treatment for relapsing-remitting multiple sclerosis (RRMS).~   "
255002|NCT00213122|"~     In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2~     diabetic patients treated with insulin.~   "
255003|NCT00213109|"~     The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in~     patients with Type1 Diabetes Mellitus treated with insulin.~   "
255004|NCT00213096|"~     The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal~     contraceptives containing a progestin and an estrogen on liver proteins and coagulation~     factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring~     containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was~     compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and~     ethinyl estradiol.~   "
255005|NCT00213083|"~     The purposes of this study are to determine whether Carraguard® Gel can prevent the~     transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe~     for vaginal use.~   "
255006|NCT00213070|"~     The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in~     patients with Type2 Diabetes Mellitus with treated insulin.~   "
255007|NCT00213057|"~     The primary aims of the study were to assess the safety and acceptability of Carraguard~     applied vaginally prior to sexual intercourse for six months in both women and men; and to~     examine several dimensions of acceptability. Secondary aims were to gauge reactions to a~     non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe~     preliminary indications of sexually transmitted infections and reproductive tract infections~     averted.~      The hypothesis was that Carraguard would cause little or no significant irritation, including~     lesions; and that women and men would find Carraguard acceptable.~   "
255155|NCT00211094|"~     The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal~     ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).~   "
255008|NCT00213044|"~     Randomized, controlled, double-blinded, cross-over trial of 60 HIV-infected women recruited~     from general medical clinics, family planning clinics, groups/organizations working with~     persons living with AIDS to assess product safety, effect on genital tract HIV shedding, and~     product acceptability with vaginal use of Carraguard gel among HIV-infected women. Women had~     to be abstinent or in a seroconcordant relationship with only one partner for the study~     period.~   "
255009|NCT00213031|"~     The primary aims of the study were to assess the safety and acceptability of PC-515 when~     applied vaginally at least three times weekly for 12 months. Secondary aims were to gather~     preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of~     HIV, and other STIs.~      The hypothesis was that Carraguard would cause little or no significant irritation, including~     lesions; and that women would find Carraguard acceptable. The study was not powered to~     determine effectiveness, but based on safety, acceptability and feasibility parameters, the~     outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3~     trial.~   "
255010|NCT00213018|"~     The primary aims of the study were to assess the safety and acceptability of Carraguard ™~     (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims~     were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female~     transmission of HIV.~      The hypothesis was that Carraguard would cause little or no significant irritation, including~     lesions; that women would find Carraguard acceptable. The study was not powered to determine~     effectiveness, but based on safety, acceptability and feasibility parameters, the outcome of~     the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 efficacy~     trial.~   "
255011|NCT00213005|"~     The study objectives were to assess the mucosal safety of Carraguard® gel when applied~     vaginally once per day for 14 days by sexually abstinent and sexually active, HIV-positive~     women; to evaluate the effect of Carraguard® gel on the vaginal flora in these women; to~     evaluate the effect of Carraguard® gel on shedding of HIV-1 in the genital tract of these~     women; to evaluate the safety of Carraguard® gel when applied directly to the penis once per~     day for 7 days by sexually abstinent, HIV-positive men; to assess whether symptoms reported~     by female and male participants during the study may be related to the use of Carraguard®~     gel; and to examine dimensions of the acceptability of, and compliance with, the study and~     placebo products.~   "
255012|NCT00212992|"~     This study will compare the effect of constant low-level energy [150 joules] to an escalating~     energy [200-300-360 joules] regimen of biphasic waveform defibrillation on multiple patient~     outcomes.~   "
255013|NCT00212979|"~     Kidney transplantation is the preferred treatment for permanent kidney failure. Following~     transplantation, the kidney function must be followed closely to detect problems so that~     investigations and appropriate treatment can be started early. Currently, function is~     monitored with the use of serum creatinine. In clinical trials involving kidney transplant~     recipients, markers of kidney function, such as serum creatinine, are increasingly being used~     as outcomes to evaluate new treatments. However, serum creatinine is not very accurate or~     sensitive at detecting change in kidney transplant function. Newer methods of evaluating~     kidney function, such as the Modification of Diet in Renal Disease (MDRD) equation and~     cystatin C, are known to be accurate markers of function in patients with non-transplant~     kidney disease. This study will compare the MDRD estimate and cystatin C estimate of kidney~     function with an accepted method (radioisotope clearance study) of measuring true kidney~     function in 250 renal transplant patients. Each patient will have 2 measurements made at~     least 3 months apart to determine the accuracy and responsiveness to change over time for the~     MDRD equation and cystatin C. If the results demonstrate that these new methods are accurate~     then clinical care and research studies involving transplant patients will be greatly~     enhanced. Patients and physicians would have a simple test that could detect problems earlier~     and more precisely monitor response to treatment leading to improved outcomes for renal~     transplant recipients.~   "
255014|NCT00212966|"~     The purpose of this study is to assess how a multidisciplinary team of mental health~     professionals provides services to patients from two family medicine practices.~   "
255015|NCT00212953|"~     The purpose of the study is to evaluate the incremental benefit of a full advanced life~     support EMS program on the outcomes of chest pain, respiratory and major trauma patients.~   "
255016|NCT00212940|"~     The purpose of this study is to determine whether a psycho-educational intervention can help~     people living with HIV handle the changes of treatment adherence.~   "
255017|NCT00212927|"~     1. INTRODUCTION: Continuity of care (COC) occurs when separate elements of patient care are~     connected. COC is made up primarily of Continuity of Provider (COP) and Continuity of~     Information (COI). Many authorities believe that COC is essential to high-quality care.~     Previous studies have shown poor COC in varied populations. Many studies have shown that~     increased COC has been associated with improved intermediate outcomes. However, no study has~     definitively determined whether COC or either of its components is associated with important~     outcomes. The Ontario-Outcomes After the Hospitalization (Ontario-OAtH) study will enroll~     5900 adults who are discharged to the community from medical and surgical services from 13~     teaching and community hospitals in 5 regions across Ontario. Patients will be followed for 6~     months to record details about all interactions with the health care system. This information~     will give us a detailed measure of both provider and information continuity for all patients~     over time. The Ontario-OAtH study will have the power to precisely determine whether COC is~     associated with time to urgent readmission or death after hospital discharge. Since COC is~     potentially modifiable, the Ontario-OAtH study will give us essential information required~     for designing interventions to improve outcomes for patients after they are discharged from~     hospital.~   "
255018|NCT00212914|"~     In 1998, The Canadian Diabetes Association published guidelines that recommended women~     diagnosed with gestational diabetes mellitus (GDM,) should be screened postpartum for Type 2~     diabetes using a glucose tolerance test. We determined the rate of screening for Type 2~     diabetes at the Ottawa Hospital before and after the publication of this guideline and found~     that none of the women in either period had been screened following this recommendation. We~     believe a reminder letter outlining the recommended screening test sent to the patient and/or~     her family physician would increase screening for Type 2 diabetes in women with previous GDM.~   "
255021|NCT00212875|"~     The primary objective of this study is to compare the change in hemoglobin (Hb) from study~     start to the end of the study between the every 2 week and the every 4 week dosing regimens~     in patients with anemia of chronic kidney disease (CKD) initiated on PROCRIT (epoetin alfa).~     Protocol Addendum: The primary objective of the open-label extension portion of this study is~     to evaluate if epoetin alfa 40,000 Units given under the skin every six weeks, can maintain~     hemoglobin within the range of 11-12 g/dL in patients with anemia of CKD.~   "
255022|NCT00212862|"~     The purpose of this study is to describe patient characteristics, treatment patterns, and~     clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating~     therapy (EST).~   "
255023|NCT00212849|"~     The purpose of this study is to measure the outcomes of patients who have articular cartilage~     lesions in the patellofemoral joint and are treated with the Autologous Chondrocyte~     Implantation.~   "
255024|NCT00212836|"~     Treatment with conventional antipsychotics such as haloperidol has little effect or may~     sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and~     poor rapport) of schizophrenia. The newer atypical antipsychotics agents, such as~     olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. The~     purpose of this study is to compare an investigational compound (asenapine) with a marketed~     agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of~     schizophrenia for 6 months. Patients completing this study may be eligible to participate in~     an extension 6 months of treatment. Patients are required to have stable symptoms prior to~     entry into study.~   "
255025|NCT00212823|"~     The purpose of this study is to evaluate the effectiveness and safety of AXERT when treating~     a migraine at the onset of headache pain, as compared to treating a migraine only after the~     headache pain has reached at least moderate intensity..~   "
255026|NCT00212810|"~     The purpose of this study is to determine whether Topiramate is effective in preventing the~     development of chronic daily headache among patients with episodic migraine headaches.~   "
255027|NCT00212797|"~     The primary purpose of this study is to determine whether subjects with psychotic major~     depression benefit from adjunctive treatment with Org 34517. Two doses of Org 34517 will be~     compared to placebo in this international multicenter study. The duration of this trial is 6~     weeks.~   "
255028|NCT00212784|"~     The primary features of schizophrenia and schizoaffective disorder are characterized by~     positive (inability to think clearly and distinguish reality from fantasy) and negative~     symptoms (reduction or absence of normal behavior or emotions). Other symptoms include~     reduced ability to recall and learn information, difficulty in problem solving or maintaining~     productive employment. Asenapine is an investigational drug that may help to correct the~     above characteristics of schizophrenia by altering the inbalance of brain hormones such as~     dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of~     asenapine using an active comparator (olanzapine) in the treatment of patients with~     schizophrenia. Patients who complete the 12-month trial will have the option of continuing on~     drug until the treatment code for the 12-month trial is unblinded.~   "
255029|NCT00212771|"~     The primary features of schizophrenia and schizoaffective disorder are positive (inability to~     think clearly and distinguish reality from fantasy) and negative symptoms (reduction or~     absence of normal behavior or emotions). Other symptoms include reduced ability to recall and~     learn information, difficulty in problem solving maintaining productive employment.~      Asenapine is an investigational drug that may help to correct the above schizophrenia by~     altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term~     extension trial to further test the efficacy and safety asenapine and a comparator agent~     (olanzapine) in the treatment of patients with schizophrenia.~   "
255030|NCT00212758|"~     Treatment with growth hormone (GH; a hormone made by the body that stimulates growth) has~     been shown to be helpful in treating children with chronic kidney disease who fail to grow.~     The amount of growth that is seen in children treated with growth hormone varies widely for~     unknown reasons. Growth hormone works by producing another hormone in the liver called~     insulin-like growth factor-1, or IGF-1 for short. IGF-1 stimulates the bones to grow. The~     amount of IGF-1 in the blood may directly affect the amount of growth in each child. At this~     time, growth hormone therapy in children depends on giving a certain dose of growth hormone~     for each child based on his or her weight. If after 3-6 months on this dose of growth hormone~     the change in height is not enough, then the dose of growth hormone is increased until enough~     growth is seen. This method of dosing of growth hormone may take a long time and is~     complicated and time-consuming.~      The purpose of this study is to measure the amount of IGF-1 produced by the body as a result~     of giving 2 different doses of growth hormone in children for 7 days only. The study~     investigator hopes to find the most favorable level of IGF-1 generated after 7 days of growth~     hormone that correlates with good growth of children with kidney disease. Then instead of~     dosing growth hormone by weight, like is done now, researchers can dose growth hormone by the~     amount of IGF-1 that the body produces. Being able to dose more effectively will save~     valuable time for the child to grow and will shorten the overall duration of growth hormone~     therapy.~      The investigators will also determine the effect of inflammatory cytokines Il-6 and TNF-alpha~     on growth hormone insensitivity and hence IGF-1 generation test in the same population.~   "
255031|NCT00212745|"~     The purpose of this research study is to see if a behavioral program which includes a~     relaxation technique and lifestyle changes can improve seizure control and well-being in~     epilepsy patients.~   "
255032|NCT00212732|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in~     patients with overactive bladder.~   "
255033|NCT00212719|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with~     involutional osteoporosis.~   "
255034|NCT00212706|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in~     patients with overactive bladder.~   "
255035|NCT00212693|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients~     with Parkinson's Disease~   "
255036|NCT00212680|"~     The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy~     and safety in patients with postoperative supraventricular tachyarrhythmias.~   "
255037|NCT00212667|"~     The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with~     involutional osteoporosis.~   "
255041|NCT00212615|"~     XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with~     metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be~     randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the~     evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or~     chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening~     days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).~      Bloodsamples will be collected and frozen and later examined for potential predictive factors~   "
255042|NCT00212602|"~     The purpose of this study is to examine the efficacy and safety of ONO-7436 for the~     prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant~     tumor~   "
255043|NCT00212589|"~     Until recently, bolus 5-flourouracil (FU) + folinic acid (FA) has been considered the~     standard chemotherapy for patients with colorectal cancer. Several studies have shown that~     Capecitabine is as effective as Mayo regimen. The Nordic FU/FA schedule was developed to be~     an active and tolerable bolus regimen. The Nordic regimen consists of a short (3 minutes)~     bolus injection of FU and 30 minutes later FA for 2 consecutive days each 2 weeks. In~     randomized studies efficacy is comparable to other FU/FA regimens.~      It is claimed that patients prefer oral therapy and in a randomized study comparing oral~     therapy (UFT/FA) and bolus FU/FA (Mayo) 84% preferred oral therapy.~      In the present randomized cross-over study patients were randomized for 3 courses of Nordic~     FU/FA followed by 2 courses of Capecitabine (or vice versa), and patients were asked for~     their preference.~   "
255044|NCT00212576|"~     This project will measure the degree to which parenting programs based in pediatric primary~     care can be effective in promoting language development and school readiness in at-risk young~     children.~      The study is a randomized controlled trial in which two different primary care-based~     parenting programs will be compared to a control group in a population that is at risk on the~     basis of poverty. The two programs represent varying levels of low intensity, but each has~     the same goals: enhancing parent-child interaction in order to improve language, cognitive~     and social-emotional development and ultimately promote school readiness and school~     performance.~      One program is called the Video Interaction Project. While waiting to see the primary care~     provider for well child care, the family meets with a child development specialist, who~     videotapes the parent and infant interacting together. The videotape is then rewound and~     watched together by the parent (and infant!) and child development specialist. This leads to~     a discussion about child development, infant cues and parenting, with the child development~     specialist building on observed strengths in the interaction. In addition, families are~     provided with parenting pamphlets developed for the project, and with inexpensive~     developmentally stimulating toys.~      The other program is called the ASQ-Building Blocks Project. This project employs a public~     health approach to facilitate parental engagement in child development. Families are sent~     monthly newsletters that focus on child development, infant cues and parenting; included with~     each newsletter is an inexpensive, developmentally stimulating toy. In addition, families~     periodically receive Ages and Stages Questionnaires, which they complete and mail back to the~     program. Based on the questionnaires, the program determines whether the infant has screened~     positive for possible developmental delay and provides this information to both the family~     and the primary care provider.~      This study will test 2 hypotheses:~        1. Primary care based parenting interventions can impact parent-child interaction, early~          child development and school readiness.~        2. Interventions of differing intensity will have impacts of differing magnitude depending~          on the risk level of the family.~   "
255045|NCT00212550|"~     Obtain sputum smears within one day to rule out TB~   "
255046|NCT00212537|"~     Gene and protein bank to study disease modifying and susceptibility genes and proteins in~     urban patients with asthma.~   "
255047|NCT00212511|"~     The purpose of this study is to create a database of demographics and samples in idiopathic~     pulmonary fibrosis.~   "
255048|NCT00212498|"~     To create a Tuberculosis Research Blood Bank for future molecular genetics and serological~     studies~   "
255049|NCT00212485|"~     The purpose of this study is to see whether power Doppler sonography (PDS) can be used to~     diagnose synovitis in patients with inherited bleeding disorders.~   "
255050|NCT00212472|"~     The purpose of this study is to see if a low-dose arm or a high dose-arm of immune tolerance~     is more effective in eliminating inhibitors in patients with hemophilia A.~   "
255051|NCT00212459|"~     The study will see if counselling adolescents with severe or moderate Hemophilia A or B~     results in increased compliance in the maintenance of bleeding logs.~   "
255052|NCT00212446|"~     Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart~     pacemaker to deliver a weak electrical current to the human uterus that will rapidly and~     safely inhibit the unwanted premature uterine contractions of preterm birth.~   "
255053|NCT00212433|"~     To ascertain which of four combinations of low residue diet, reduced laxative dose and oral~     contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT~     colonography~   "
255054|NCT00212420|"~     To Investigate whether different routes of nutrition affect the probability of fistula~     closure in patients with an enterocutaneous fistula~   "
255055|NCT00212407|"~     Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow~     reconstitution in patients who would be potential candidates for a bone marrow transplant~     from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord~     blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft~     vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.~   "
255056|NCT00212394|"~     The purpose of the study is to establish the number and nature of complications that we, the~     researchers, have with the use of a tourniquet in orthopaedic surgery in Norway.~   "
255057|NCT00212381|"~     To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable~     based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical~     dysplasia in otherwise healthy women.~   "
255058|NCT00212368|"~     The purpose of this study is to determine whether Zinc Acetate is effective and safe in the~     treatment of Wilson's disease among Japanese.~   "
255059|NCT00212355|"~     The purpose of this long-term study is to determine whether Zinc Acetate is effective and~     safe in the treatment of Wilson's disease among Japanese.~   "
255060|NCT00212342|"~     The purpose of this study is to determine whether combination oral contraceptive pill of~     Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated~     with endometriosis.~   "
255061|NCT00212329|"~     Type 1 diabetes is a condition that is caused in part by an abnormality of the immune system~     which occurs when T cells, which are part of the immune system, damage the insulin secreting~     cells (islet cells) in the pancreas. Although it is known that T cells are important~     mediators of the disease, progress in the development of reliable T cell assays has been~     modest. The purpose of this study is to learn which T cell assays are most reliable and~     reproducible so that the investigators can improve their understanding about how type 1~     diabetes occurs.~   "
255063|NCT00212303|"~     The coexistence of diabetes and hypertension is damaging to cardiac and peripheral vascular~     structure and function. Although several health organizations endorse exercise training as a~     treatment for type 2 diabetes, most studies of exercise and diabetes have focused on~     controlling blood sugar but not on cardiovascular health. The aim of this study is to~     determine if exercise training reduces blood pressure and improves cardiovascular health in~     persons who have both type 2 diabetes and hypertension. An equal number of men and women will~     be enrolled, and another aim of the study is to examine gender differences in response to~     exercise training.~   "
255064|NCT00212290|"~     The purpose of this study is to examine the effects of treating insulin resistance on memory~     and attention, brain glucose utilization, and proteins in spinal fluid.~   "
255065|NCT00212277|"~     The purpose of this long-term study is to determine whether combination oral contraceptive~     pill of Norethindrone & Ethinyl estradiol is effective in the treatmentof dysmenorrhea~     associated with endometriosis.~   "
255066|NCT00212264|"~     The primary purpose of this study is to test the effectiveness, impact on quality of life,~     and durability of non-surgical therapies for incontinence persisting at least one year after~     surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week,~     multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring~     with bladder diaries, regular office visits, bladder control techniques, and fluid~     management) to the same program with the addition of biofeedback and pelvic muscle electrical~     stimulation.~   "
255067|NCT00212251|"~     The purpose of this study is to evaluate, in a five-year randomized controlled trial, the~     efficacy of an intervention (AMP - ACTIVE MOTHERS POSTPARTUM) to increase physical activity~     and promote a healthy diet (decreased calorie and fat intake) for weight loss among~     postpartum women who were overweight or obese prior to pregnancy. The hypothesis is that the~     proportion of women losing at least 10% of BMI from baseline to 12 months post-intervention~     will be significantly greater in the AMP intervention arm than in the minimal care arm.~   "
255068|NCT00212238|"~     The purpose of this study is to compare two Internet-based behavioral weight loss programs.~   "
255069|NCT00212225|"~     Helicobacter pylori (Hp) is a major cause of chronic-active gastritis and primary duodenal~     ulcers, and is strongly linked to gastric cancer. Most Hp infections worldwide are acquired~     in childhood. Why some individuals develop symptomatic disease is unclear and, until~     recently, no studies critically evaluated the role of pediatric Hp strains and/or host~     factors in disease outcomes. Over the past 5 years of National Institutes of Health (NIH)~     funding, 486 children from Atlanta, Cleveland, and Miami were enrolled; 184 (38%) were~     Hp-infected. Race (African American) and younger age, in conjunction with Hp strains~     expressing cagA and vacAs1B, were shown to be risk factors for both esophageal and gastric~     disease, suggesting a different disease paradigm from Hp-infected adults. Using the updated~     Sydney system, the investigators demonstrated a histopathologic spectrum in children, which~     included novel observations of atrophic gastritis with intestinal metaplasia.~      Overall hypothesis for competitive renewal: disease manifestations in Hp-infected children~     are influenced by specific host factors (i.e., race, immune phenotype), environmental~     exposures, and specific virulence factors of infecting Hp strains.~      Specific aims:~        1. Using well defined cases and controls, further characterize specific host factors and~          environmental exposures contributing to symptomatic childhood infection emphasizing~          targeted enrollment in specific age, gender and demographic strata to facilitate~          detection of significant differences not attained previously and follow-up of 2~          established specific cohorts to ascertain immune response natural history.~        2. Utilize gene-array technology for the whole Hp genome assessment and bacterial gene~          expression of specific virulence determinants associated with pediatric Hp strains.~        3. Further characterize the host immunologic and mucosal response in Hp-infected children.~      Hp-infected symptomatic endoscopy cases at the investigators' established 3 clinical centers~     of high, moderate and low Hp prevalence will be compared with age-matched Hp-infected~     asymptomatic and uninfected symptomatic controls. Two geographically and demographically~     distinct centers have been added to provide additional geographic and subject~     representativeness to the patient cohort. The updated Sydney system will be employed to~     assess gastric histopathology severity and phenotype in newly enrolled cases in specific age,~     gender and demographic strata and follow-up of the two novel cohorts established in the~     past 5 years: a) atrophic gastritis; and b) esophageal and gastric disease groups enabling a~     comprehensive, multivariate evaluation of the natural history of Hp-infected children in two~     distinct disease paradigms.~      Using molecular methods (multiplex [MP]-PCR, RT-PCR) and a micro ELISPOT assay on peripheral~     blood mononuclear cells (PBMCS), Th1, Th2, Th3 or balanced Th1/Th2 response will be~     determined to further characterize the Hp-infected child's immune response phenotype. The~     investigators propose to further their previous work with critically lacking studies from a~     multivariate approach, leading to a better understanding of the gastroduodenal disease~     sequelae and overall pathobiology of Hp infection in humans.~   "
255070|NCT00212212|"~     This study is being conducted to determine if patients with cirrhosis (liver disease) are~     selenium deficient. The effect of supplementation with two chemical forms of selenium on~     plasma selenium biomarkers will be determined and correlated with the severity of the liver~     disease.~   "
255071|NCT00212199|"~     The purpose of this study is to test the effectiveness of three different methods for~     delivering weight management information. Two methods utilize an obesity drug and the third~     method utilizes brief behavioral counseling sessions only.~   "
255072|NCT00212186|"~     The purpose of this study is to determine whether patients with liver disease can improve~     their nutritional selenium status by taking supplemental selenium.~   "
255073|NCT00212173|"~     Protocol #1:The goals of this study was to examine whether increased weight loss in obese~     adolescent is induced when the weight loss medication sibutramine is added to a family-based,~     behavioral weight control program.~      Protocol #2: This study aims to improve the behavioral treatment of obesity during~     adolescence. A behavioral program using regular foods will be compared to a behavioral~     program using a structured meal plan (a portion-controlled approach with liquid-meal~     replacements [nutritional supplements]). This structured approach may be better for the~     promotion of weight loss compared to a diet of regular foods.~   "
255074|NCT00212160|"~     The purpose of this research is to determine some of the reasons that blood sugar and insulin~     levels improve after bariatric surgery but before weight loss begins, as well as why people~     respond differently to weight loss surgery. It will also examine whether removing the fat~     around the stomach and large intestine (the omentum) will improve weight loss. Finally, it~     will see why there are differences between Whites and African Americans who have weight loss~     surgery.~   "
255075|NCT00212147|"~     Low cobalamin (vitamin B12) levels are frequent in the elderly. Most often they reflect a~     mild metabolic abnormality without clinical symptoms (subclinical cobalamin deficiency). It~     is unclear if these elderly people require medical intervention, unlike that small minority~     with clinical symptoms which can progress and create severe blood or nervous system problems.~     The study aims to determine if nitrous oxide (N2O), a common anesthetic agent, worsens~     cobalamin status in elderly patients with unrecognized subclinical cobalamin deficiency. The~     reason for concern is that N2O inactivates cobalamin and can aggravate the clinical picture~     of patients who already have clinical manifestations of cobalamin deficiency. The elderly are~     known to have an increased risk of developing mental changes after surgery and it may be that~     sometimes these result from aggravation of subclinical cobalamin deficiency.~      The study recruits people over the age of 60 years who are undergoing clinically indicated~     elective surgery requiring general anesthesia for more than 1 hour. Patients meeting~     exclusion and inclusion criteria are randomized to receive either a standard anesthetic~     regimen that includes N2O or a nearly identical one without N2O. Before surgery and 2 weeks~     and 4 weeks after surgery, each patient undergoes (1) a broad battery of tests of cognition~     and mood and (2) blood tests measuring cobalamin, folate and homocysteine-methionine~     metabolism to determine whether they have any subtle biochemical impairment of cobalamin~     status. DNA from blood cells is also tested for the presence of common mutations that affect~     key enzymes in those metabolic pathways. A brief testing for postoperative delirium is also~     done 2 hours after surgery.~      The patient subgroups' are analyzed for neuropsychologic changes over time, using the~     preoperative test as the baseline for all comparisons, and associations of those changes with~     metabolic, genetic, demographic and clinical data.~      The primary question is what effect routine N2O exposure has on the latter compared with~     non-N2O anesthesia in elderly people who either have or do not have subclinical cobalamin~     deficiency. It will help answer whether or not the combination can help explain the increased~     risk of cognitive problems after surgery in elderly patients, and by extension whether~     preoperative cobalamin testing and treatment may be indicated in the elderly. It will also~     test whether genetic predisposition affects the described problems.~   "
255076|NCT00212134|"~     The primary purpose is to determine whether infants with a unilateral congenital cataract are~     more likely to develop better vision following cataract extraction surgery if they undergo~     primary implantation of an intraocular lens or if they are treated primarily with a contact~     lens. In addition, the study will compare the occurrence of postoperative complications and~     the degree of parental stress between the two treatments.~   "
255077|NCT00212121|"~     hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control~     at 10 years from 88% to 93%, with still acceptable cosmesis.~   "
255078|NCT00212108|"~     EGFR and COX-2 are involved in tumorigenesis, angiogenesis and metastases and are frequently~     over expressed in NPC.COX-2 and EGFR inhibitors are active in NPC.There is synergistic action~     between COX-2 and EGFR inhibitors.~      Study hypothesis: Celecoxib and gefitinib can reduce angiogenesis and induce~     anti-tumorigenicity in patients with nasopharngeal cancer.~   "
255079|NCT00212095|"~     Patients with locally advanced or metastatic breast cancer and with measurable primary breast~     tumor will be treated with 70mg docetaxel combined with ketoconazole. Serial tumor biopsies~     and plasma samples will be taken for gene expression and proteomics studies to identify~     biomarkers that may predict for treatment response.~   "
255080|NCT00212082|"~     We hypothesize that changes in tumor gene expression profiles vary in response to different~     sequences and types of chemotherapy, and that gene expression changes will correlate with~     tumor response. We are also looking to correlate drug pharmacokinetics and treatment toxicity~     with genotype of drug metabolizing enzymes and tranporters.Patients with metastatic breast~     cancer and who have measurable primary breast tumor will be randomized to one of two~     alternating sequences of adriamycin and docetaxel. Serial tumor biopsies and plasma samples~     will be obtained for gene expression and proteomic studies to identify biomarkers that will~     predict for chemotherapy response.~   "
255081|NCT00212069|"~     Tumors are heterogeneous with varying response to chemotherapeutic agents. We hypothesize~     that tumors that are sensitive to a particular chemotherapeutic agent have a distinctive~     tumor protein profile compared to those that are resistant. We further hypothesize that since~     tumor is continuously perfused by serum, serum protein profile can be used as a surrogate~     marker of tumor protein profile. The primary objective of this study is to identify a serum~     protein profile that predicts gemcitabine/carboplatin sensitivity or resistance in breast~     cancer patients with prior exposure to anthracyclines and taxanes. Secondary objectives are~     to establish the serum protein profile of breast cancer patients who have had prior exposure~     to anthracyclines and taxanes, and to study the pharmacogenetics of gemcitabine toxicity by~     correlating germline genotype of transporters and drug metabolizing enzymes with plasma and~     intracellular gemcitabine pharmacokinetics.~   "
255082|NCT00212056|"~     To evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and~     improves regional wall motion.~   "
255083|NCT00212043|"~     Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation~     and be more effective clinically in non-small cell lung cancer~   "
255084|NCT00212030|"~     To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct~     size and improves regional wall motion~   "
255085|NCT00212017|"~     The purpose of this study is to evaluate whether an alpha-glucosidase inhibitor, a drug for~     the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial~     infarction in patients with impaired glucose tolerance (IGT) and old myocardial infarction.~   "
255086|NCT00212004|"~     To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction~     (MI) in patients with DM and old myocardial infarction~   "
255087|NCT00211991|"~     This study answers a U.S. Food and Drug Administration requirement for evaluation in people~     of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three~     lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of~     vaccine, and typical vaccine safety information is also collected.~   "
255088|NCT00211978|"~     The purpose of this study is to determine if calcium acetate (PhosLo) can control serum~     phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.~   "
255089|NCT00211965|"~     Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections~     associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine~     which contains the purified capsular polysaccharides that have been implicated as a major~     factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus~     prior to surgery could provide sufficient antibody concentrations during surgery and the~     wound healing period so as to decrease the risk of S. aureus infection. This study aims to~     demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are~     candidates for orthopedic surgery.~   "
255090|NCT00211952|"~     The aim of the study is to assess the influence of celecoxib on relapse-free survival in~     completely resected patients with poor prognosis indicated by metastatic involvement of~     intrapulmonary/hilar (pN1) or ipsilateral mediastinal (pN2) lymph nodes. Celecoxib, a~     selective oral COX-2 inhibitor, was found to exert significant anti-proliferative activity~     against a variety of tumor cell lines in vitro, including NSCLC. COX-2 is frequently~     up-regulated in NSCLC cell lines and archival tumor samples. Its high expression was also~     correlated with poor prognosis of the patients. A clinical trial addressing the role of~     celecoxib as adjuvant treatment in radically operated patients with high risk of relapse is~     warranted.~   "
255091|NCT00211939|"~     The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and~     sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive~     technique, electron beam computed tomography (CT) scanning, to measure calcium in the~     coronary arteries, the aortic valve, and the mitral valve.~   "
255092|NCT00211926|"~     S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a~     vaccine to prevent these infections, which conjugates the purified capsular polysaccharides~     of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This~     study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in~     patients who are candidates for knee or hip arthroplasty.~   "
255093|NCT00211913|"~     S. aureus is the most common pathogen encountered in infection associated with cardiovascular~     surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified~     capsular polysaccharides (CPS) that have been implicated as a major factor in the~     invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to~     surgery could provide sufficient antibody concentrations during surgery and during the wound~     healing period so as to decrease the risk of S. aureus infection. This study aims to~     demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are~     candidates for cardiovascular surgery.~   "
255094|NCT00211900|"~     This study answers a U.S. Food and Drug Administration requirement for evaluation in people~     of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The~     antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety~     information is also collected.~   "
255095|NCT00211887|"~     This is for a randomized clinical trial (RCT) to determine if the combined use of interferon~     beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent~     used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).~   "
255096|NCT00211874|"~     For congestive heart failure (CHF) patients with systolic dysfunction, a randomized~     controlled trial compared nurse-based disease management to address problems in patient and~     clinician management with usual care for effects on hospitalization and functioning among~     ethnically-diverse patients in ambulatory practices.~   "
255097|NCT00211848|"~     The primary aim of this investigation is to evaluate the effect of a combined antiviral,~     antifibrotic and antioxidant treatment on the progression of liver disease in patients with~     hepatitis C who either abstain from alcohol or continue to drink. All subjects are given~     state-of-the-art antiviral treatment (pegylated interferon + ribavirin), supplemented with~     either placebo or polyenylphosphatidylcholine (PPC), a purified soybean extract consisting of~     95-96% polyunsaturated phosphatidylcholines (PC) and which has both antifibrotic and~     antioxidant properties. Secondary aims are to verify whether moderate alcohol consumption~     interferes with the antiviral effect of pegylated interferon + ribavirin on HCV and to~     validate the reliability of various circulating markers as substitute for liver biopsies to~     indicate the stage of liver pathology and its propensity for progression.~   "
255098|NCT00211835|"~     Randomized clinical trial that compares the effects of cognitive behavioral therapy (CBT) and~     supportive psychotherapy for depression. Short- and long-term outcomes will be evaluated in~     terms of changes in mood (primarily depression and anxiety), participation in activities and~     life satisfaction.~   "
255099|NCT00211822|"~     This study will explore the brain processes associated with inhibition and reward processing~     in pathological gamblers and people with obsessive compulsive disorder compared to healthy~     controls.~   "
255100|NCT00211809|"~     The research project is a controlled pilot study of the efficacy of cognitive-behavioral~     therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body~     dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to~     relaxation and stress management training (RSMT), an active control treatment~   "
255101|NCT00211796|"~     12-week open label treatment trial of divalproex sodium extended release (Depakote ER) in 10~     patients with a diagnosis of autism. Our objective is to determine how well these patients~     can tolerate the prescribed doses and what added benefits can be attributed to divalproex~     sodium ER.~   "
255102|NCT00211783|"~     This study investigates face processing, response inhibition and phoneme processing in~     autistic adults by fMRI.~   "
255103|NCT00211770|"~     Autism, originally described by Kanner (1943), is among the most severe of neuropsychiatric~     disorders. It is a pervasive developmental disorder affecting social, communicative, and~     compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements,~     craving for sameness, and narrow repetitive interests. Individuals with autism spectrum~     disorders (ASD) are characteristically heterogeneous and show marked variability in their~     response to interventions. Studies of behavioral and psychopharmacological interventions~     document approximately 1/3 of ASD participants fail to respond to targeted treatments.~     Efforts to evaluate the specificity of treatment effects are important to inform~     conceptualizations about the disorder, identify behavioral phenotypes, and to aide clinical~     decision making.~      The goal of this study is to evaluate the use of clinical behavioral pharmacology methods,~     functional behavioral assessments (FBA), in assessing the treatment effects of pediatric~     medications in children with ASD. The present study of FBA procedures in pharmacological~     treatment will be conducted as a separate, but parallel study within IRB approved, federally~     funded, double-masked, placebo controlled medication trials of citalopram (GCO # 01-1295~     PS*), an SSRI hypothesized to reduce stereotyped and repetitive behaviors in ASD and~     divalproex sodium (GCO # 01-0294), a medication recently found to reduce repetitive behaviors~     in ASD (Hollander et al., in press). This study will focus on the use of FBAs in~     distinguishing responders vs. nonresponders on the basis of behavior function, in evaluating~     functional patterns for stereotypy, aggression, and impulsivity, and in using descriptive~     FBAs as outcome measures in clinical trials.~      FBAs are behavioral assessment methods used to hypothesize about the function of maladaptive~     behaviors. FBAs are conducted either through experimental manipulations known as functional~     analyses or through descriptive analyses procedures, which involve structured observations~     and parent/caregiver interviews. Descriptive analyses will be conducted with all participants~     (n=24). The more rigorous, functional analyses will be conducted with a sub-set of the sample~     (n=6) to corroborate the findings of the descriptive analyses. Data from the FBAs will be~     collected using videotaped recordings of behavior and coded by trained raters for both the~     descriptive and experimental analyses.~      Our pilot data and other published data suggest that certain medications such as citalopram~     (celexa) and divalproex sodium (Depakote) may improve global functioning in autistic patients~     and repetitive/compulsive behaviors and social deficits. The addition of FBA methods to~     evaluate outcome are an important step in extending the research and knowledge of the~     conditions associated with good and poor treatment response to pediatric medications in~     children with autism.~   "
255104|NCT00211757|"~     The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs.~     placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview~     (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although~     behavioral and educational therapies and a variety of medications may play a role in the~     management of some autistic symptoms.~   "
255105|NCT00211744|"~     A 12-week program to examine the effectiveness of topiramate in adjunctive treatment for~     adults with obsessive-compulsive disorder and who are currently on serotonin reuptake~     inhibitor medications (ages 18-65).~   "
255106|NCT00211731|"~     This study focuses on causes of under-use of secondary stroke preventive measures~     demonstrated in randomized clinical trials to be efficacious, but not appropriately utilized~     in urban, minority populations.~   "
255107|NCT00211718|"~     The purpose of this study is to determine whether intra-articular botulinum toxin type A is~     effective in the treatment of chronic joint pain.~   "
255108|NCT00211705|"~     To evaluate the primary preventive effect of low-dose pravastatin against coronary heart~     disease (CHD) in Japanese hypercholesterolemic patients.~   "
255109|NCT00211692|"~     Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro~     compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN~     has greater antiviral activity in patients with genotype 1 hepatitis C infection,~     particularly if given as a daily injection. These data indicate that the use of a regimen of~     daily CIFN and ribavirin will lead to greater virologic response rates compared with~     pegylated interferon alfa-2b and ribavirin in patients with genotype 1 infection, with~     comparable adverse events. Emerging data indicate that HCV genotype 1 patients with a delayed~     virologic response to initial therapy may benefit from an extended duration of therapy.~     Therefore, the goals of this pilot study are to determine the tolerability and efficacy of~     daily CIFN plus ribavirin when given for 52 weeks or an extended duration of therapy. The~     target population will consist of difficult-to-treat patients, defined as having the~     following characteristics: genotype 1, a North American patient population, predominantly~     male gender, and no specific exclusions for pre-existing psychiatric or substance abuse~     co-morbidities.~   "
255110|NCT00211679|"~     The purpose of this study is to determine whether intra-articular injection of botulinum~     toxin is effective in the treatment of chronic knee paindue to arthritis.~   "
255113|NCT00211640|"~     Male patients between the ages of 18 to 100 years of age who entered the Mid Michigan Health~     Center were administered a patient demographic questionnaire, a Lower Urinary Tract Symptom~     (LUTS) questionnaire, and the Men's Sexual Health Questionnaire (MSHQ) without exception. The~     purpose of this study was to better identify symptoms of benign prostatic hyperplasia (BPH)~     with the intent to prescribe better and more helpful treatment options for patients~     demonstrating these symptoms.~   "
255114|NCT00211627|"~     Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to~     treat simple snoring.~   "
255115|NCT00211614|"~     Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working~     middle-aged adults in the United States. Obesity is the number one risk factor for the~     development of OSA. Consequences of untreated OSA are varied and significant and included~     numerous neuropsychiatric parameters such as mood alterations, depression, anxiety,~     diminished social interactions, and decreased quality of life. Mounting evidence suggests~     that treatment of OSA can improve many of these outcomes. The primary treatment modality for~     this condition is continuous positive airway pressure (CPAP). This device delivers positive~     pressure to the upper airway in order to prevent its collapse during sleep. Unfortunately,~     many patients do not choose to use CPAP or have difficulty with these devices. This results~     in many individuals with OSA either going without therapy or unable to reap the full benefits~     of treatment.~      Gastroesophageal reflux (GERD) is also common in the United States and may, in some~     instances, be directly related to weight gain. Survey studies have suggested that symptomatic~     GERD is more common in patients with OSA. Whether there exists a cause and effect~     relationship between these two conditions is not known at present. It has been suggested that~     GERD may contribute to OSA by narrowing the upper airway.~      This study will examine the effect of treatment of GERD on mild to moderate OSA. Fifty~     individuals identified as having mild to moderate OSA (diagnosed by overnight sleep study or~     PSG) and GERD (confirmed by an esophageal probe) will be enrolled. Both men and women will be~     included in this study and no “special populations” will be utilized. Subjects will fill out~     questionnaires to subjectively measure sleepiness, OSA-related symptoms, GERD-related~     symptoms, and sleep apnea-related quality of life. They will then be randomized to receive~     either 12 weeks of the proton pump inhibitor lansoprazole (Prevacid) or placebo (twenty five~     subjects per group). Upon completion of the 12 week trial, subjects will return and the~     following data will be collected; repeat all of the baseline questionnaires, repeat PSG and~     repeat pH probe.~      Results from this study will help to establish the relative effectiveness of a novel form of~     therapy for a common yet difficult to manage medical condition. . The risks to subjects~     enrolled in the study are minimal and therefore the benefit to risk ratio is heavily in favor~     of performing the study.~   "
255116|NCT00211601|"~     The purpose of this study is to assess whether timely feedback to providers on patient~     experiences with delayed chemotherapy induced nausea and vomiting (CINV) lead to differences~     in patient outcomes for subsequent cycles.~   "
255117|NCT00211588|"~     The aim of the study is to determine whether galantamine stabilizes or improves thinking~     abilities in individuals with Parkinson's disease. Individuals included in the study have~     minor complaints about thinking such as problems with concentration or memory but do not have~     dementia. This medication has been shown to have a positive effect on stabilizing memory in~     individuals with Alzheimer's disease. It is FDA approved for use in elderly individuals with~     Alzheimer's disease. It is hypothesized that galantamine will stabilize or improve executive~     and attentional functions in individuals with Parkinson's.~   "
255118|NCT00211575|"~     This research study was designed to help improve the diagnosis and treatment of asthma in~     young children. An interventional strategy using a scoring system based on risk factors and~     symptoms/episodes was tested to determine its ability to identify children likely to benefit~     from induction of asthma controller therapy at an early age. The score was derived through~     completion of a survey instrument referred to as the asthma risk questionnaire (ARQ). The~     utility of the ARQ along with the health care utilization and use of controller therapy for~     respiratory illnesses within one year were examined.~   "
255119|NCT00211562|"~     This research study helps to demonstrate that adding vitamins and fats (nutritional~     supplements) to a diet will help reduce body weight and improve the lipid profile. This will~     be done by examining the body weight and chemicals in the blood. The chemicals are the result~     of the brain using the fat that subjects eat in their diet. Some medications may also change~     the amount of these chemicals in a person's blood.~   "
255120|NCT00211549|"~     The purpose of this study is to identify the dose(s) of IDEA-033 that will provide a~     meaningful effect for treating osteoarthritis of the knee.~   "
255121|NCT00211536|"~     The purpose of this study is to evaluate the effectiveness of insulin delivered in the~     peritoneum (abdomen)by an implantable pump in Type 1 diabetics.~   "
255122|NCT00211523|"~     This study investigates the safety and efficacy of MBI 226 2.5% and 5.0% Acne Solutions,~     applied topically for six weeks, in the treatment of acne.~   "
255123|NCT00211510|"~     The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm~     722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control~     when compared to subjects using the Paradigm 715 insulin pump only.~   "
255124|NCT00211497|"~     This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to~     evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions~     as anti-acne preparations in human subjects with facial acne vulgaris.~   "
255125|NCT00211484|"~     A compassionate method of treatment is offered to patients where lesions do not meet~     acceptable criteria for standard therapy. Visudyne (Photodynamic Therapy) and laser~     photocoagulation treatment (a treatment using heat from a fine point laser beam) have not~     been found to be effective in treating the lesions these patients have.~      Anecortave acetate is an experimental drug that is being tested to prevent the growth of~     blood vessels under the retina in patients with age-related macular degeneration (AMD).~   "
255126|NCT00211471|"~     To provide use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients~     with rubeosis iridis. Rubeosis iridis refers to neovascularization of the iris. It is caused~     by a number of conditions which include, but are not limited to severe diabetic retinopathy,~     central retinal vein occlusion, chronic inflammation, and infection. Anecortave acetate is an~     angiostatic, experimental drug that is being tested to prevent the growth of blood vessels~     under the retina in patients with age-related macular degeneration (AMD). Therefore, it is~     logical to apply the usage of Anecortave to patient’s with rubeosis iridis in order to reduce~     the neovascularization stimulus and cause the regression of the abnormal iris vessels.~   "
255127|NCT00211458|"~     The purpose of this study is to provide compassionate use of anecortave acetate sterile~     suspension of 15 mg for a series of five patients as a means to control classic~     neovascularization following failure of treatment with photodynamic therapy using Visudyne.~   "
255128|NCT00211445|"~     Central serous choroidal (CSC) retinopathy is a disease of the macula characterized by~     exudation of fluid under the retina localized to the posterior pole as well as loss of~     vision. The etiology is unknown, but according to the studies this condition is more common~     in young males and is associated with type A personality. Clinically, CSC is characterized by~     serous retinal detachment and area of leakage of in the subretinal space. The standard of~     care for acute CSC is observation for a period of up to 3 months. If there is no complete~     resolution of the retinal detachment by 3 months, there is an indication for focal laser~     photocoagulation therapy of the area of leakage. This treatment is usually effective in~     stopping leakage of fluid under the retina and causing resolution of detachment. However,~     laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because~     there is not a single easily identifiable point of leakage but rather diffuse disease of RPE~     thus rendering laser treatment ineffective.The purpose of this medical research study is to~     evaluate Verteporfin therapy as an approach which may benefit patients with CSC, based on~     observations in exudative type of AMD patients treated with Photodynamic Therapy using~     Verteporfin.~   "
255129|NCT00211432|"~     The purpose of this study is to provide compassionate use of anecortave acetate sterile~     suspension of 15 mg for a series of five patients as a means to control pseudovitelliform~     detachment.~   "
255130|NCT00211419|"~     The purpose of this study is to evaluate the safety of combining juxtasclerally administered~     anecortave acetate 15 mg with triamcinolone acetate 4 mg administered intravitreally~     following photodynamic therapy with verteporfin for the treatment of exudative age-related~     macular degeneration (AMD).~   "
255131|NCT00211406|"~     The purpose of this study is to provide compassionate use of anecortave acetate sterile~     suspension of 15 mg for a series of five patients as a means to control diabetic retinopathy.~   "
255132|NCT00211393|"~     The purpose of this study is to determine the effect of an adrenocorticoid antagonist~     (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous~     chorioretinopathy (CSC).~   "
255133|NCT00211380|"~     This is the sister study to the BMS Cognitive Improvement with Aripiprazole (Abilify) study~     (LSUHSC #H04-022). Evaluation of cognitive ability in patients with schizophrenia or~     schizoaffective disorder both before and after a switch from risperidone, olanzapine, or~     risperidone Consta injections to aripiprazole may reveal some of the cognitive changes that~     correlate with the improved response, better side effect profile, and effects on other~     components of the negative symptom array. Further, examination of brain functional activity~     using functional magnetic resonance imaging (fMRI) during an episodic memory task, as well as~     behavioral performance and associated electroencephalographic (EEG) data of working memory~     and intermediate term verbal memory collected with the Sustained Attention and Memory Brain~     Function Test (SAM-BFT), may also provide data showing the neural correlates of these changes~     in cognition.~   "
255134|NCT00211367|"~     Radiation retinopathy is a disease of the retina. It occurs in people who have received or~     been exposed to radiation near the eyes. The blood vessels are abnormal and may grow which~     lead to scarring and a loss of central vision. Currently, the treatment for radiation~     retinopathy is laser photocoagulation. This treatment has been found to have limited use in~     this type of condition. Compassionate use of anecortave acetate injection is being considered~     to prevent the growth of the blood vessels under the retina.~   "
255135|NCT00211354|"~     Retinal Vein Occlusion is a blockage of the blood vessels that drain out of the retina.~     Complications of retinal vein occlusion which threaten vision include~     neovascularization(growth of new blood vessels)and macular edema ( accumulation of fluid~     leaking from abnormal blood vessels). Currently, the treatment of retinal vein occlusion is~     laser photocoagulation. This treatment has found to have limited use in this type of~     condition.Anecortave Acetate is being considered as an attempt to control the growth of the~     abnormal blood vessels.~   "
255136|NCT00211341|"~     Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of~     reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with~     the impact on overall mortality.~      Hypotheses:~        1. Weekly supplementation with vitamin A (7000 µg retinol equivalent [RE]) to reproductive~          age women will reduce maternal deaths by 33%.~        2. This impact will be achieved by reductions in both pregnancy-related and~          non-pregnancy-related deaths.~        3. There will be a reduction in non-maternal deaths, similar in size to that in maternal~          non-pregnancy related deaths.~      Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be~     identified through monthly demographic surveillance, and classified as maternal~     (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.~   "
255137|NCT00211328|"~     Idiopathic Perifoveal telangiectasia is a poorly understood disorder that involves the growth~     of blood vessels around the center of the macula(perifoveal region). These blood vessels may~     extrend beneath the retina to produce an area of sub-retinal neosvascularization(growth of~     abnormal blood vessels under the retina which leak fluid, causing reduction in vision.~     Limited forms of treatment are available in managing the neovascularization and its~     consequences. Anecortave Acetate injection is considered as an attempt to control the growth~     of the abnormal blood vessels.~   "
255138|NCT00211315|"~     Congenital Telangiectasia or Coat's disease is an uncommon disorder that involves the growth~     of blood vessels of the macula. These blood vessels msy extend beneth the retina to produce~     an area of sub-retinal neovascularization(growth of abnormal blood vessels under the retina~     which leak fluid, causing reduction in vision). Limited forms of treatment are available in~     managing the neovascularization and its consequences. Anecortave Acetate injection will be~     considered as an attempt to control the growth of the abnormal blood vessels.~   "
255139|NCT00211302|"~     Evaluation of cognitive ability in patients with schizophrenia or schizoaffective disorder~     both before and after a switch from risperidone to aripiprazole may reveal some of the~     cognitive changes that correlate with the improved response, better side effect profile, and~     effects on other components of the negative symptom array. Further, examination of brain~     functional activity using functional magnetic resonance imaging (fMRI) during a verbal~     learning task, as well as behavioral performance and associated electroencephalographic (EEG)~     data of episodic memory, working memory and intermediate term verbal memory collected with~     the Sustained Attention and Memory Brain Function Test (SAM-BFT), may also provide data~     showing the neural correlates of these changes in cognition.~   "
255140|NCT00211289|"~     The emphasis of this grant is to investigate ways to educate patients, not only to improve~     their knowledge about medications and diet that are important for better outcomes in heart~     failure, but also to try to understand how patients' beliefs about medication and diet affect~     their behaviour and to what extent the investigators can help patients change.~      Hypotheses: Heart failure patients who receive an enhanced educational intervention from~     their community pharmacist will:~        1. have an absolute risk reduction in the number of events of 20%,~        2. be more compliant,~        3. demonstrate less health-related quality of life (HRQoL) impairment as measured by~          disease-specific and generic HRQoL instruments and~        4. have lower costs/quality adjusted life years due to fewer total events per patient.~   "
255141|NCT00211276|"~     The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin~     diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients~     whose disease has not responded to prior treatments, or has relapsed after an initial~     response to prior treatments. The safety of treatment with ONTAK will also be studied. The~     hypothesis is that patients with relapsed or refractory B-cell NHL and mild to moderate~     myelosuppression treated with ONTAK at a new dosing regimen will respond sufficiently to~     warrant further study.~   "
255142|NCT00211263|"~     The Bipolar Disorder Center for Pennsylvanians aims to reduce significant differences in~     treatment results among Pennsylvanians with bipolar disorder, especially among youth, the~     elderly, rural residents, and African Americans who are less likely to receive adequate~     treatment, less likely to remain in treatment once identified, and less likely to have~     positive results if they remain in treatment. Half of the subjects receive either Guideline~     Intervention (GI) or Enhanced Clinical Intervention (ECI). ECI is a combination of~     information and support, such as education about bipolar disorder, the medications used to~     treat it, information about sleep practices and habits that affect quality of sleep, review~     of symptoms, medication side effects, and coping with side effects. It is predicted that~     Enhanced Clinical Intervention will be more effective in reducing the differences in results~     between those most at risk compared to mid-life Caucasians. The treatment study occurs at~     three sites across Pennsylvania and has emphasized the recruitment of African Americans,~     youth (ages 12 through 18), and adults over age 65.~   "
255143|NCT00211250|"~     The purpose of this study is to compare compliance, tolerability, effectiveness, and~     side-effects in Bipolar I and II patients switching from Valproic Acid to Depakote ER.~   "
255144|NCT00211237|"~     The primary objective of this study is to evaluate the safety and effectiveness of balloon~     kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared~     to standard non-surgical therapy in patients with cancer.~   "
255145|NCT00211224|"~     NNIPPS is a clinical trial of riluzole (a drug previously shown to slow down the rate of~     progression og amyotrophic lateral sclerosis-ALS; Lou Gehrig's disease) involving nearly 800~     people diagnosed with the 'parkinson plus' syndromes of multiple system atrophy (MSA) and~     progressive supranuclear plasy (PSP). In addition to showing whether riluzole is helpful in~     MSA and PSP, NNIPPS will improve criteria for making an accurate and early diagnosis, for~     assessing the rate of progression, and will advance understanding of the biology of these~     disabling and progressive neurodegenerative diseases.~   "
255146|NCT00211211|"~     The primary objective of this study is to compare the effectiveness of standard medical~     therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body~     compression fractures.~   "
255147|NCT00211198|"~     The purpose of this research study is to evaluate how effective ONTAK is in the treatment of~     cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein~     called CD25 on the cancer cells makes a difference in how the body responds to the treatment.~      The hypothesis is that there is no difference in response rate for patients whose tumor cells~     are CD25 positive or negative.~   "
255148|NCT00211185|"~     Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral~     T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study~     will also compare what kind of side effects these drugs cause and how often they occur. The~     hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK~     + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when~     compared to CHOP alone.~   "
255149|NCT00211172|"~     The primary goal of this study is to evaluate the effectiveness of direct-to-patient mailings~     designed to increase patient's adherence to prescribed beta-blockers following an acute~     myocardial infarction (AMI).~      Prior to developing patient materials, focus groups were conducted with patient who had~     previously suffered an acute myocardial infarction (AMI) to identify the issues and~     information that patients felt were important to include in our materials as well as the best~     way to present the information. Additionally, patient materials were pre-tested with AMI~     patients to ensure that the materials were clear and easy to read and that the key messages~     were understood.~   "
255150|NCT00211159|"~     Memory loss and difficulties with thinking associated with Alzheimer's disease (AD) may be~     due to a deficiency in the brain of a fatty acid named DHA. The aim of this trial is to see~     if dietary supplementation with a preparation, rich in DHA, will halt cognitive impairment in~     AD patients~   "
255151|NCT00211146|"~     This study is designed to investigate the incidence of deep vein thrombosis in patients~     receiving a perisurgical regimen of epoetin alfa (PROCRITÂ®) as compared to patients~     receiving standard of care blood conservation management.~   "
255152|NCT00211133|"~     The purpose of this study is to evaluate the impact on survival and quality of life of~     maintaining hemoglobin in the range of 12 to 14 g/dL using epoetin alfa or placebo in~     patients starting chemotherapy for metastatic breast cancer for the first time.~   "
255153|NCT00211120|"~     The purpose of this study is to compare the outcomes of patients with chronic kidney disease~     (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin~     levels. This study will test the primary hypothesis that the level of anemia correction with~     once weekly dosing of PROCRITÂ® (Epoetin alfa) in patients with chronic kidney disease will~     decrease mortality and cardiovascular morbidity.~   "
255154|NCT00211107|"~     The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal~     ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).~   "
255156|NCT00211081|"~     Ultrasound is a technique that can provide images of the blood vessels such as arteries. The~     size of the arteries, such as the main blood vessel in the arm, can change under different~     conditions. Using ultrasound we can see how arteries change with movement or even drugs. We~     want to use ultrasound to see how blood vessels look in patients with Congestive Heart~     Failure (CHF) and to also see how a drug called Spironolactone, commonly prescribed for~     patients with this disease, effects blood vessel function in patients with congestive heart~     failure. This information may be used to change the standard of care for patients with heart~     failure especially if we show that Spironolactone has a positive effect on vessel function in~     patients with CHF.~   "
255157|NCT00211068|"~     The purpose of this study is to collect historical occurrences of risk factors that are~     potentially associated with the development of anti-erythropoietin (EPO) antibody positive~     pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been~     recently treated with epoetin alfa (EPREX).~   "
255158|NCT00211055|"~     The purpose of this study is to determine the incidence of anemia and blood transfusions and~     management of these in critically ill children~   "
255159|NCT00211042|"~     The purpose of this study is to investigate the relationship of anti-erythropoietin~     antibodies to the clinical course and outcome of pure red cell aplasia (PRCA) in participants~     currently or previously treated with recombinant human erythropoietin.~   "
255160|NCT00211029|"~     The purpose of this study is to record the number of participants with chronic renal disease~     who are receiving treatment with epoetin alfa or other recombinant erythropoietins who~     develop pure red cell aplasia (PRCA, a rare form of anemia) during the study period.~   "
255161|NCT00211016|"~     The purpose of this study is to compare the clinical response rate of doripenem versus~     comparator in patients with ventilator-associated pneumonia (VAP).~   "
255162|NCT00211003|"~     The purpose of this study is to compare the safety and effectiveness of doripenem in patients~     with hospital-acquired pneumonia (HAP).~   "
255163|NCT00210990|"~     The purpose of this study is to assess the microbiological cure rate of doripenem in the~     treatment of patients with complicated urinary tract infection or pyelonephritis. The study~     will also characterize the safety and tolerability of treatment with doripenem in patients~     with complicated urinary tract infection or pyelonephritis.~   "
255164|NCT00210977|"~     The purpose of this study is to assess the presence of anti erythropoietin antibodies (anti~     EPO Ab) in participants responding to any erythropoietin receptor agonist (ERA) therapy to~     treat or prevent anemia without loss of effectiveness to see if they will develop pure red~     cell aplasia or loss of effectiveness to recombinant erythropoietin and to measure the~     duration of effectiveness of ERA therapy.~   "
255165|NCT00210964|"~     The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the~     water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator~     in the treatment of patients with nosocomial pneumonia.~   "
255166|NCT00210951|"~     The purpose of this study is to assess the incidence of pure red cell aplasia (PRCA~     [suppression of erythropoiesis with little or no abnormality of leukocyte or platelet~     production]) among participants with chronic renal failure (CRF), who were receiving~     treatment with epoetin alfa or other exogenous recombinant erythropoietin therapies.~   "
255167|NCT00210938|"~     The purpose of this study is to compare the clinical response rates of doripenem versus a~     comparator antibiotic in treatment of hospitalized patients with complicated intra-abdominal~     infections.~   "
255168|NCT00210925|"~     The purpose of this study is to evaluate the safety and effectiveness of topiramate compared~     to placebo in patients with alcohol dependence.~   "
255169|NCT00210912|"~     The purpose of this study is to assess the safety and effectiveness of topiramate as compared~     to placebo for the prevention of headaches in patients with chronic migraine. Topiramate has~     been approved to prevent migraine headaches as well as in the treatment of epilepsy.~   "
255170|NCT00210899|"~     The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril~     versus a comparator in the treatment of patients with complicated skin and skin structure~     infections. The study will also characterize the safety and tolerability of treatment with~     ceftobiprole medocaril in patients with complicated skin and skin structure infections.~   "
255171|NCT00210886|"~     The purpose of this study is to evaluate the effectiveness and safety of two antibiotics in~     the treatment of complicated urinary tract infection or acute pyelonephritis (kidney~     infection). A 5-day course of 750 milligrams of levofloxacin given intravenously and/or by~     mouth once daily will be compared to a 10-day course of 400 milligrams of ciprofloxacin given~     intravenously and/or 500 milligrams of ciprofloxacin given by mouth twice daily.~   "
255172|NCT00210873|"~     The purpose of this study is to assess the long-term safety and effectiveness of topiramate~     for the prevention of headaches in adults with chronic migraine. Topiramate has been approved~     to prevent migraine headaches.~   "
255173|NCT00210860|"~     The purpose of this study is to assess the long-term safety and effectiveness of topiramate~     for the prevention of migraine headaches in adults. Topiramate has been approved to prevent~     migraine headaches in adults.~   "
255174|NCT00210847|"~     The purpose of this study is to explore the pain-reieiving effects and safety of tramadol~     HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic~     neuropathy. Treatment of neuropathic pain often requires the use of more than one medication.~     The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful~     diabetic neuropathy comes from the multiple mechanisms of action in this combination pain~     medication. Patients who experience painful diabetic neuropathy will be enrolled in this~     study.~   "
255175|NCT00210834|"~     The primary objective of this study is to compare end of study hemoglobin levels between~     Epoetin alfa at 40,000 units administered subcutaneously once every week and at 80,000 units~     subcutaneously every two weeks in anemic patients with cancer receiving chemotherapy. The~     secondary objectives of the study are to assess the Hb response, time to Hb response,~     transfusion requirements, and safety.~   "
255176|NCT00210821|"~     The purpose of this study is to compare the effectiveness and safety of two treatment~     regimens in preventing migraines. The antidepressant amitriptyline has been used successfully~     to prevent migraine headaches.~   "
255177|NCT00210808|"~     The purpose of this study is to evaluate the safety and effectiveness of topiramate compared~     to placebo in reducing the number of binge days in patients with moderate to severe~     binge-eating disorder associated with obesity.~   "
255178|NCT00210795|"~     The purpose of this study is to assess changes in physical function in elderly patients (>=~     65 years of age) with chronic anemia (Hb <= 11.0 g/dL) due to anemia of unknown cause and~     receiving weekly subcutaneous doses of Epoetin alfa (PROCRITÂ®) versus placebo~   "
255179|NCT00210782|"~     The purpose of this study is to compare the effectiveness and safety of two treatment~     regimens, topiramate as compared to phenytoin, in preventing seizures in patients with~     new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for~     requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug~     to an effective dose, may include severe or frequent seizures, or high risk to the patient of~     recurrent seizures.~   "
255180|NCT00210769|"~     The purpose of this study is to evaluate the long-term safety and tolerability and the~     maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone~     administered once daily to patients diagnosed with schizophrenia.~   "
255181|NCT00210756|"~     The purpose of this study is to describe the pharmacokinetics (PK) of six different dosing~     regimens of epoetin alfa (PROCRITÂ®) in anemic critically ill subjects~   "
255182|NCT00210743|"~     The purpose of this study is to evaluate the hemoglobin response rate in subjects with~     anemia, associated with chronic kidney failure, after receiving epoetin alfa (PROCRITÂ®)~     every 2 weeks~   "
255183|NCT00210730|"~     The purpose of this study is to compare the efficacy of epoetin alfa (PROCRITÂ®) administered~     subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRITÂ®) treatment in~     patients with cancer who are anemic.~   "
255184|NCT00210717|"~     The purpose of this study is to compare the effectiveness and safety over 1 year of treatment~     of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients~     with schizophrenia.~   "
255185|NCT00210704|"~     The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal~     ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).~   "
255186|NCT00210691|"~     The purpose of this study is to document the long-term safety and tolerability of~     risperidone, formulated as a long-acting injectable, in the treatment of patients with~     schizophrenia or schizoaffective disorder; in addition, to evaluate the long-term~     effectiveness of long-acting risperidone and its effect on quality of life~   "
255187|NCT00210678|"~     The purpose of the study is to characterize intravaginal ejaculatory latency time (time~     between the start of vaginal intercourse and the start of intravaginal ejaculation) in men~     with and without premature ejaculation (PE) and to assess the validity of patient-reported~     outcomes.~   "
255188|NCT00210665|"~     The purpose of this study is to facilitate access to trabectedin for eligible previously~     treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from~     currently available therapeutic options but who may benefit from treatment with trabectedin.~     The safety profile of trabectedin will be evaluated to further assess the potential risks of~     trabectedin treatment.~   "
255189|NCT00210652|"~     The purpose of this study is to evaluate the safety and preliminary effectiveness of the~     novel compound RWJ-333369 in patients with partial onset seizures who are currently being~     treated with 1 or 2 concomitant antiepileptic drugs.~   "
255190|NCT00210639|"~     The purpose of this study is to assess the long-term safety of levofloxacin administered to~     children as therapy for acute bacterial infection.~   "
255191|NCT00210626|"~     The purpose of this trial is to evaluate the physical function outcomes in anemic, critically~     ill, trauma subjects treated with epoetin alfa (PROCRIT®) compared to placebo.~   "
255192|NCT00210613|"~     The primary purpose of the study is to assess the possible withdrawal effects after abruptly~     stopping daily therapy with dapoxetine compared with continuing daily therapy in men with~     premature ejaculation (PE).~   "
255193|NCT00210600|"~     The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa)~     when administered at 120,000 Units once every three weeks by comparing early dosing (Hb~     11g/dL-12g/dL) vs. standard dosing (Hb< 11g/dL).~   "
255194|NCT00210587|"~     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa~     (PROCRITÂ®) administered 80,000 Units every three weeks in cancer patients that are not~     receiving chemotherapy or radiation therapy.~   "
255195|NCT00210574|"~     Limited data exist on the effectiveness of antiepileptic drugs for treatment of childhood~     absence epilepsy. Preliminary data suggest that topiramate may be an effective drug for this~     condition. The present study is designed to provide further evidence of the potential~     effectiveness of topiramate for childhood absence epilepsy, as well as preliminary~     information about a potential target dose for future study.~   "
255196|NCT00210561|"~     The purpose of this study is to explore the pain-relieving effects and safety of Tramadol~     HCl/acetaminophen as compared to placebo in patients experiencing acute low back pain.~     Tramadol HCl/acetaminophen is approved for short-term management of acute pain. The~     combination of tramadol HCl/acetaminophen has been shown to be effective for the treatment of~     acute musculoskeletal pain. Patients who experienced at least moderate acute low back pain~     for 2 to 10 days before study entry will be randomized to receive either tramadol~     HCl/acetaminophen or placebo.~   "
255197|NCT00210548|"~     The purpose of this study is to evaluate the effectiveness and safety of 3 doses of~     paliperidone palmitate in treating subjects with schizophrenia.~   "
255198|NCT00210535|"~     The primary purpose of this study is to evaluate the effectiveness and safety of topiramate~     compared with placebo in the prevention of migraine attacks in children (12 to 17 years of~     age).~   "
255199|NCT00210522|"~     The purpose of this study is to evaluate the effectiveness and safety of the novel compound~     RWJ-333369 in reducing the frequency of seizures in patients with epilepsy.~   "
255200|NCT00210509|"~     The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate~     (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine~     headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for~     the treatment of migraine headache, with or without aura, in adults. Patients in this study~     will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.~   "
255201|NCT00210496|"~     The purpose of this study is to evaluate the impact of topiramate (migraine prevention~     medicine) on the effectiveness of almotriptan malate (acute migraine medicine) when treating~     acute migraine headaches.~   "
255202|NCT00210483|"~     The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate~     (AXERT®) in treating acute migraine headaches in adolescents. Amotriptan malate (AXERT®) is~     approved for use in the treatment of acute migraine headache with or without aura in adults.~     In this study, adolescents will be given a single dose of study medication to treat one~     migraine headache.~   "
255203|NCT00210470|"~     IRX-2 is designed to activate your own body's immune system so that it can better fight the~     invasion of head and neck cancer. In pre-clinical studies, IRX-2 has been shown to activate a~     number of different cells of the immune system.~      IRX-2 was previously tested in a study of 13 patients with advanced head and neck cancer who~     had been previously treated and failed chemotherapy and/or radiation therapy. The trials were~     specifically designed to test the safety of IRX-2. Researchers found that IRX-2 did not~     appear to have major side effects. Also, the researchers believed that further study in less~     advanced head and neck cancer patients could be useful in obtaining more data on the safety~     of IRX-2 as well as data on possible effects on tumors and on patient survival.~   "
255204|NCT00210457|"~     To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel~     given in doses titrated to effect in acromegalic patients previously treated or not with~     somatostatin analogues.~   "
255205|NCT00210444|"~     To evaluate the effect on healing rates of two different prognostic factors in patients~     treated with Dysport® for anal fissure: duration of fissure and dose of study drug~   "
255206|NCT00210431|"~     The purpose of this study is to provide further information regarding the risks and benefits~     of Dysport in marketed indications.~   "
255207|NCT00210418|"~     The objective of this study is to compare two approaches to targeting donated supplementary~     food to young children. The study compares the effectiveness of the widely-used curative~     approach where targeting is based on the child's poor nutritional status to a preventive~     approach which targets children in poor communities solely on the basis of age and provides~     supplementary food to all children aged 6-23 months. Cost-effectiveness of the two targeting~     approaches will also be assessed.~   "
255208|NCT00210405|"~     The objective of this study is to test the feasibility and effectiveness of distributing~     micronutrient sprinkles to 6-20 month old children participating in an integrated maternal~     and child health and nutrition program in rural Haiti. The micronutrient sprinkles have been~     formulated to prevent or treat anemia in 6-23 month old children. Effectiveness in reducing~     the prevalence of anemia will be assessed.~   "
255209|NCT00210392|"~     The primary objective of this study is to assess the antitumor activity (in terms of overall~     response rate - ORR - i.e. sum of complete and partial responses) of bortezomib in pretreated~     MALT lymphomas with more than one prior systemic therapy regimen~   "
255210|NCT00210379|"~     The primary objective assess the clinical activity of combination doxorubicin-containing~     chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic~     chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to~     assess the toxicity of this therapeutic strategy~   "
255211|NCT00210366|"~     The main objective of the trial is to assess the therapeutic activity of idarubicin as~     salvage treatment in patients with recurrent or progressive lymphoma in the central nervous~     system.~   "
255212|NCT00210353|"~     Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab~     in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will~     improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.~      In April 2006, a third arm of treatment was added to compare the antitumor activity and~     safety of rituximab alone vs chlorambucil alone~   "
255213|NCT00210340|"~     The purpose of this study is to define the safety profile of rituximab given intrathecally in~     lymphomatous meningitis related to CD20+ non-Hodgkin's lymphomas.~   "
255214|NCT00210327|"~     The primary objective of this study is to assess the antitumor activity (in terms of overall~     response rate - ORR - i.e. sum of complete and partial responses)of bortezomib in pretreated~     MALT lymphomas with one prior sistemic therapy regimen~   "
255215|NCT00210314|"~     Aim of the study is to establish in a prospective, randomized clinical trial the activity of~     primary chemotherapy containing high dose-methotrexate, alone or combined with high dose~     cytarabine, in patients with primary central nervous system lymphoma~   "
255216|NCT00210301|"~     MS has been associated with fatigue, attention problems, and a number of cognitive~     difficulties. There is no treatment approved yet to treat these problems. We hypothesize that~     the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved~     fatigue, attention, and overall cognition in MS patients with attention problems.~   "
255217|NCT00210288|"~     The purpose of this study is to assess the immune response produced by two doses of SC599~     vaccine compared to placebo.~   "
255218|NCT00210275|"~     The purpose of this study is to determine whether printed educational materials can change~     physician behaviour towards more evidence based decision-making.~   "
255219|NCT00210262|"~     Diabetes mellitus (DM) imposes a significant burden of early mortality and decreased quality~     of life on the 6% of Canadians affected by it. There is a growing body of research evidence~     showing that the use of certain medications (ACE inhibitors, blood pressure medications and~     cholesterol lowering agents) can reduce the major complications of diabetes such as heart,~     blood vessel and kidney disease and amputations. Unfortunately this research knowledge does~     not appear to be routinely translated into clinical practice. The proposed study examines the~     effect of simple mailed interventions to patients or physicians on improving the use of these~     therapies. The strategies to be tested are direct patient education with an emphasis on blood~     pressure and lipid control rather than use of particular drugs and, for physicians, the~     provision of confidential prescribing feedback together with targeted educational bulletins.~     With patient and physician consent, health care administrative data will be used to examine~     the impact of the interventions. If successful, the study will identify low cost reproducible~     interventions to promote the use of proven preventive therapies in clinical practice.~   "
255220|NCT00210249|"~     Number of elderly people over 70 is increasing in France. In 2002, in the south-west, 273,741~     of them were over 75 years, i.e. 9.2% of Aquitaine population. Incidence of cancer in this~     old age is 16,500 new cases per year, more than fifty percent of people with cancer.~     Treatment modalities of elderly people is one of the 70 priorities of the Plan cancer~     instituted by the French government. They are very few therapeutic trials dedicated.~     Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of~     breaking down quality of life. Consequently, we decided to launch a protocol with both~     oncologists and geriatricians which principal aim is to find out if geriatric assessment data~     can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan~     to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate,~     lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are~     initially classified according to usual methods of medical oncology practice into three~     groups: patients who can receive standard treatment, reduced standard treatment or treatment~     adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one~     geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment~     sites in Bordeaux area and six sedentary teams which worked half a day a week in designated~     hospitals . Geriatric evaluation included test of cognitive functions (MMS), nutritional~     status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL;IADL), quality~     of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening. Patients have four~     geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or~     end of chemotherapy. Since September 2002, 177 patients have been included, 112 have~     finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3%~     stopped because they were in progression and changed their treatment, 11.6% met~     administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and~     3.6% finished their treatment before. The following results have been obtained: before~     treatment, 73% of these patients were at risk of undernutrition (MNA< 23.5), about 1/3 had~     one or more inability or a risk of falls (38% IADL<6, 29% get up and go>20seconds, 27% ADL>1,~     34% PS<1), 28% of them had altered cognitive functions (MMS<24), 29% were depressive~     (GDS-15>6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in~     September 2005.~   "
255221|NCT00210236|"~     This randomized phase III trial is studying surgery and axillary lymph node dissection to~     evaluate if systematic axillary node clearance can be avoided in locoregional treatment for~     operable breast cancer smaller than 10 mm among menopausal women older than 50~   "
255222|NCT00210223|"~     To treat breast tumors in non surgical patients with percutaneous technique (radiofrequency).~     Prospective evaluation of treatment efficiency and tolerance based on clinical and~     radiological evaluation~   "
255223|NCT00210210|"~     The surgery of breast cancer is responsible for post-operative pain, needing in about 30%~     some morphine consumption; like that, the association of ketamine with general anaesthesia~     may decrease morphine's use and so its adverse effects. The purpose is to evaluate the~     analgesic effect of a receptor NMDA's antagonist ( ketamine)~   "
255224|NCT00210197|"~     The risk of deep venous thrombosis after radical breast surgery is known. The objective of~     this study is to explore hypercoagulability after radical breast cancer surgery by studying~     several factors for haemostasis before, during and after surgery. Ultrasound Doppler~     examination is realised between 24 and 72 hours post-operatively. Hypercoagulability is~     defined by a significant increasing level of thrombin-antithrombin, D-dimer and the endogen~     thrombin potential.~   "
255225|NCT00210184|"~     The number of patients over 70 years old with cancer is increasing in France. This population~     is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a~     lot between subjects of the same age. Physicians hesitate to treat them with optimal doses~     because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty~     eight percent of gastric cancers are diagnosed in patients over the age of 70 in France.~     FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising~     treatment for digestive cancer. It increases the level of response and survival without major~     toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their~     conditions.~      The principal objectives are to demonstrate the efficacy of treatment, safety, survival and~     to find out if geriatric assessment data can help to better predict chemotherapy toxicity.~     The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic~     gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day~     1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of~     cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up~     and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and~     Lachs-Balducci screening.~   "
255226|NCT00210171|"~     Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction~     chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.~   "
255227|NCT00210158|"~     Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of~     postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could~     be exagerated and could produce greater postoperative opioid consumption and higher pain~     score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study~     was to evaluate, in patients with current opioid treatment, the effects of peroperative~     Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.~   "
255228|NCT00210145|"~     The aim of this study is to evaluate the impact of a socio-aesthetic intervention on body~     image and quality of life in post-surgical patients with mastectomy or tumorectomy for breast~     cancer.Two groups of randomized subjects were constituted. Patients of the experimental group~     received 2 or 3 aesthetic care during the first post-surgical week, whereas those of the~     control group not. Body image, quality of life and diverse other personality variables were~     assessed at three different times: surgical operation day before, exit day before of~     hospitalization and three months afterwards. Our general hypothesis is that subjects who~     receive aesthetic care report levels significantly higher of corporal satisfaction and of~     quality of life at the end of the hospitalization and three months later than patients of the~     control group.~   "
255229|NCT00210132|"~     The purposes of this study are:~        1. To determine the efficacy of inter pleural analgesia~        2. To determine the plasmatic concentration of ropivacaine by inter pleural road~   "
255230|NCT00210119|"~     Imatinib mesylate is standard treatment of Chronic myeloid leukaemia, complete cytogenetic~     response is obtained in most of cases but molecular response concerned only a small part of~     the patients. To increase molecular response ratio we decided to increase imatinib dose to~     limited resistance to this drug and to add zoledronate for it anti tumoral activity to~     increase anti leukemic effect. We plan to accrue 37 patients in 5 centers. We will analyse~     molecular expression of BCR-ABL transcript after 6 months of treatment, safety, duration of~     response, VEGF expression and LTgd production.~   "
255231|NCT00210106|"~     The hypothesis is that radiofrequency ablation combined or not with resection may allow a~     local control (the liver) in patients suffering from unresectable colorectal liver~     metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.~   "
255232|NCT00210093|"~     The purpose of this trial is to characterize the pharmacokinetics of INS37217 following~     intravenous, intranasal, and inhalation administration and to calculate the relative~     bioavailability of INS37217 when administered via oral or nasal inhalation.~   "
255233|NCT00210080|"~     The primary objective of this study is to determine if more diagnoses of lung cancer are~     obtained from the cytological evaluation of sputum expectorated following a single inhaled~     dose of UTP compared to sputum expectorated following a single inhaled dose of placebo in~     patients suspected of having lung cancer.~   "
255234|NCT00210067|"~     The purpose of this trial is to access the tolerability of INS37217 Intravitreal Injection~     when administered intravitreally in subjects with macula-on or macula-off rhegmatogenous~     retinal detachment (RRD).~   "
255235|NCT00210054|"~     The purpose of this trial is to characterize the pharmacokinetics of INS37217 following~     intravenous administration.~   "
255236|NCT00210041|"~     The purpose of this study is to determine whether association Gemcitabine-Cisplatin is~     effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or~     metastatic.~   "
255237|NCT00210028|"~     The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added~     to treatment with tamoxifen~   "
255238|NCT00210015|"~     The purpose of this study was to determine the efficacy and safety of the study drug compared~     to placebo for the treatment of subjects with perennial allergic rhinitis.~   "
255239|NCT00210002|"~     The purpose of this study is to evaluate the response rate obtained in an heterogeneous~     oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic~     treatment or by association of Darbepoetin alfa -ferric saccharose systematic~     supplementation, administered concomitantly with chemotherapy.~   "
255240|NCT00209989|"~     The purpose of this study is to determine the efficacy by the determination of the Time To~     Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5~     cm treated with the combination of ZARNESTRA plus Radiation therapy.~   "
255241|NCT00209963|"~     To evaluate the safety and tolerability of gaboxadol in primary insomnia.~   "
255242|NCT00209950|"~     To evaluate the safety and tolerability of gaboxadol in primary insomnia~   "
255243|NCT00209937|"~     To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia~   "
255244|NCT00209924|"~     To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia.~   "
255245|NCT00209911|"~     The main objectives in this study were to examine the cardiac structural and functional~     changes in patients with persistent and permanent AF, with the aim of improving our~     understanding of the underlying pathophysiological mechanisms. In addition we aimed to~     identify variables predictive of recurrent AF.~   "
255246|NCT00209898|"~     Hepatitis C infection is a prevalent chronic disease. It is particularly prevalent among~     intravenous drug abusers. Bergen fengsel is a regional prison housing 250 inmates, of which~     as many as 70 are recorded HCV RNA PCR positive annuallly. In this study inmate males and~     females will be randomized to standard screening and initiation procedure, or to a rapid~     initiation procedure in the hospital's infectious diseases outpatient clinic. The study aims~     at studying if rapid inclusion will increase the possibility to conclude treatment while the~     prisoner still is incarcerated, thus improve the chances of reaching a sustained virologic~     response, compared to standard inclusion, where prisoners, as other out patients will wait~     for inclusion for several months.~   "
255247|NCT00209885|"~     To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a~     group receiving SOC + additional perioperative analgesics in terms of postoperative~     abilities, PONV, pain and discharge time from the PACU~   "
255248|NCT00209872|"~     The purpose of this study is to test the current standard of care (SOC) treatment for~     abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional~     perioperative analgesics in terms of postoperative abilities, postoperative nausea and~     vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).~   "
255249|NCT00209859|"~     To investigate whether cyclosporine, added to methotrexate and steroid, increases the~     possibility of inflammatory management early in the disease; furthermore to investigate the~     possible steroid-sparing effect of cyclosporine in patients with recently diagnosed~     rheumatoid arthritis.~   "
255250|NCT00209846|"~     To evaluate the safety and tolerability of gaboxadol in primary insomnia.~   "
255251|NCT00209833|"~     This randomized phase II/III trial investigates the antileukemic activity and toxicity of the~     FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and~     bad response to the first induction cycle and/or with a high risk karyotype and compares the~     antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous~     peripheral blood stem cell transplantation as late consolidation therapy in standard risk~     patients.~   "
255252|NCT00209820|"~     This is a randimized clinical trial comparing the effect of supervised Nordic walking versus~     unsupervised Nordic walking versus advice to stay active~   "
255253|NCT00209807|"~     Patients with major depressive disorder (MDD) commonly have many gastrointestinal complaints.~     Gastrointestinal pain is classified into 2 categories: visceral and somatic pain. The main~     aim of this study is to compare somatic and visceral sensitivity between healthy people and~     pateints with MDD. These two sensitivities will be assessed by the 2 following tests:~     standardized rectal distension and Transdermal transcutaneous electric nerve stimulation.~     Thereafter, patients with MDD will be randomly allocated to escitalopram or reboxetine. After~     6 weeks of treatment, somatic and visceral sensitivity will be reassessed.~   "
255254|NCT00209794|"~     To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP~     [Fansidar] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months~     of age reduces de incidence of clinical malaria up to 12 months of age~   "
255255|NCT00209781|"~     We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection~     afforded by ITNs.~   "
255256|NCT00209768|"~     The purpose of this study is to determine whether the use of in-line filtration shows any~     effect on the outcome of sepsis, systemic inflammatory response syndrome (SIRS), thrombosis,~     or organ failure in critically ill children admitted to the pediatric intensive care unit~     (PICU).~   "
255257|NCT00209755|"~     Investigation of the usefullness of therapeutical drug monitoring of ribavirin for dose~     adaptation during combination therapy of chronic hepatitis C patients.~      The correlation between ribavirin plasma concentration levels at week 4 (steady state) and~     early virological response (HCV-RNA decay from baseline to week 12) is to be tested in 40~     patients approximately.~   "
255258|NCT00209742|"~     A randomized controlled study is conducted on patients with histological stage III colorectal~     cancer assigned to postoperative adjuvant therapy of uracil-tegafur plus leucovorin (UFT+LV),~     UFT+LV / UFT, or UFT+LV+PSK / UFT+PSK. The usefulness of the three regimens was evaluated by~     comparing the disease-free survival rate, overall survival rate, incidence and severity of~     adverse event, and quality of life.~   "
255259|NCT00209729|"~     To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the~     antitumor effect and survival period by performing a phase I/II study of this combination in~     Elderly patients with inoperable or with postoperative gastric cancer.~   "
255260|NCT00209716|"~     A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting~     toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and~     5-fluorouracil (TPF) in Pre-treated patients with metastatic esophageal cancer. The~     usefulness of the this regimen is evaluated by response rate, median survival time, and~     progression free survival.~   "
255261|NCT00209703|"~     We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to~     estimate the safety and efficacy of this regimen.~   "
255262|NCT00209690|"~     A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting~     toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and~     5-fluorouracil (TPF) in untreated patients with metastatic esophageal cancer. The usefulness~     of the this regimen is evaluated by response rate, median survival time, and progression free~     survival.~   "
255263|NCT00209677|"~     To assess the usefulness of Gemcitabine plus S-1 therapy based on the antitumor effect and~     survival period. By performing a phase I/II study of this combination in patients with~     inoperable or with postoperative pancreatic cancer.~   "
255264|NCT00209664|"~     To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and~     survival period. by performing a phase II study of this combination in patients with~     inoperable or with postoperative gastric cancer~   "
255265|NCT00209651|"~     To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and~     survival period. by performing a phase II study of this combination in patients with~     inoperable or with postoperative colorectal cancer.~   "
255266|NCT00209638|"~     To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and~     survival period. by performing a phase I/II study of this combination in patients with~     inoperable or with postoperative gastric cancer~   "
255267|NCT00209625|"~     We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to~     determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen~   "
255268|NCT00209612|"~     A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting~     toxicity (DLT), and efficacy of a combination chemotherapy using CPT-11 and Paclitaxel in~     pre-treated patients with metastatic gastric cancer. The usefulness of the this regimen is~     evaluated by response rate, median survival time, and progression free survival.~   "
255269|NCT00209599|"~     This study was designed to demonstrate that AQUAVAN® is effective in providing adequate~     sedation in elderly patients undergoing colonoscopy as well as to assess the safety profile~     of AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl~     citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation.~     Throughout the procedure, study personnel assessed the patient's vital signs and depth of~     sedation. After the procedure, the patient, physician, and an evaluator were asked to~     complete satisfaction surveys.~   "
255270|NCT00209586|"~     This study was designed to demonstrate that AQUAVAN® is effective in providing adequate~     sedation in patients undergoing flexible bronchoscopy as well as to assess the safety profile~     of AQUAVAN versus that of midazolam. Prior to the procedure, patients receive fentanyl~     citrate for pain management followed five minutes later by either AQUAVAN® Injection or~     midazolam HCl for sedation. During the procedure, study personnel assess the patient's vital~     signs and depth of sedation. After the procedure, the patient, physician, and an evaluator~     are asked to complete satisfaction surveys.~   "
255271|NCT00209573|"~     This study was designed to demonstrate that AQUAVAN® is effective in providing adequate~     sedation in patients undergoing colonoscopy as well as to assess the safety profile of~     AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl citrate~     for pain management followed five minutes later by AQUAVAN® Injection for sedation.~     Throughout the procedure, study personnel assessed the patient's vital signs and depth of~     sedation. After the procedure, the patient, physician, and an evaluator were asked to~     complete satisfaction surveys.~   "
255272|NCT00209560|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN®~     Injection when used for mild-to-moderate sedation in patients undergoing minor surgical~     procedures.~   "
255273|NCT00209547|"~     The anticipation of pain and discomfort, a diagnosis, and other intrinsic unknowns make~     patients anxious both prior to and during a procedure. Therefore, the main goal of sedation~     with analgesia used during various diagnostic, therapeutic, or surgical procedures is to~     relieve this anxiety, discomfort, and pain, which are all interrelated. The optimal level of~     sedation for any given patient is one that allows the patient to tolerate the procedure and~     provides an appropriate safety margin. This was a study designed to examine the safety and~     efficacy of AQUAVAN® Injection versus a commonly used approved sedative drug, midazolam HCl~     following pretreatment with fentanyl citrate injection (for pain relief) in producing~     sedation in patients undergoing single cardiac catheterization procedures.~   "
255491|NCT00206622|"~     To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2~     (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot~     flushes in postmenopausal women~   "
255274|NCT00209534|"~     This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing~     adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients~     received fentanyl citrate for pain management followed five minutes later by AQUAVAN®~     Injection for sedation. Throughout the procedure, study personnel assessed the patient's~     vital signs and depth of sedation. After the procedure, the patient, physician, and an~     evaluator were asked to complete satisfaction surveys.~   "
255275|NCT00209521|"~     This is an exploratory clinical trial designed to examine the efficacy, safety and~     tolerability of fospropofol (AQUAVAN) Injection compared to propofol (DISOPRIVAN) Injectable~     Emulsion when used to preoperatively sedate, induce, and maintain general anesthesia and to~     postoperatively sedate patients undergoing elective coronary artery surgery.~   "
255276|NCT00209508|"~     This study was designed to assess whether GPI 1485 has the ability to delay or stop disease~     progression and improve symptoms in patients with Parkinson's disease (PD) that is already~     being treated with a dopamine agonist therapy. Whether the drug is working will be assessed~     by evaluating clinical endpoints such as UPDRS scores and by evaluating images, obtained by~     SPECT scan, of brain activity. Participants in the study will be given either placebo or GPI~     1485 treatment. The duration of the study is 2-years and patients are required to complete 12~     safety visits and 3 SPECT scans. SPECT scans will be taken before, after 1-year, and after~     2-years of treatment with GPI 1485. In completing the SPECT scan, patients will be injected~     with a radioactive investigational drug b-CIT and pictures taken using a Single Photon~     Emission Computed Tomography (SPECT) camera.~   "
255277|NCT00209495|"~     Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine.~     Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is~     unpleasant for the patients and sometimes keeps them at bed longer time than needed. We~     investigate in new combinations of analgesics for postoperative pain, hoping to minimize the~     need for morphine.~   "
255278|NCT00209482|"~     This study will determine if the drug metformin, coupled with diet and exercise counseling,~     will help obese adolescents lose weight.~   "
255279|NCT00209469|"~     This study is evaluating the use of the drug alendronate in preventing or reversing bone loss~     in children and adolescents receiving steroid medications.~   "
255280|NCT00209456|"~     The study is designed to determine the diagnostic efficacy of the visual assessment of SPECT~     scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB~     dementia subjects determined by the clinical diagnosis of an independent expert consensus~     panel used as the standard of truth.~   "
255281|NCT00209443|"~     Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging~     (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow~     in the arterial vessels throughout the body.~      Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by~     directly injecting it into the vein, but this procedure has not been formally tested to image~     the aorto-iliac vessels using MR.~      The study is designed to determine the presence or absence of a relevant stenosis (ie greater~     than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction~     Angiography (IADSA) will be used as the standard of truth.~   "
255282|NCT00209430|"~     The main purpose of this study is to evaluate and compare the effects on kidney function of~     two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at~     risk of kidney damage associated with the injection of contrast media. A standard hydration~     procedure, based on available guidelines will be given to all patients to prevent negative~     effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up~     to 7 days after contrast media administration to evaluate the effects on renal function.~   "
255283|NCT00209417|"~     It is well known that X-ray contrast media can affect kidney function in some patients,~     especially when administered intra-arterially, and patients who already suffer from reduced~     kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use~     low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast~     media-induced nephropathy. However, little is known about the intravenous use of X-ray~     contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose~     of this study is to evaluate and compare the effects on kidney function of two contrast~     media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney~     damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is~     expected less influence on renal function following administration of iodixanol. A standard~     hydration procedure, based on available guidelines will be given to all patients to prevent~     negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured~     before and up to 7 days after contrast media administration to evaluate the effects on renal~     function.~   "
255284|NCT00209404|"~     Image quality in coronary artery computed tomography is influenced by the heart rate~     variation during the examination. The purpose of this clinical trial is to investigate the~     change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol).~     Image quality and diagnostic quality of the examination will be evaluated.~   "
255285|NCT00209391|"~     Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging~     (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow~     in the arterial vessels throughout the body.~      Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by~     directly injecting it into the vein, but this procedure has not been formally tested to image~     the renal artery vessels using MR.~      The study is designed to determine the presence or absence of a relevant stenosis (ie greater~     than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction~     Angiography will be used as the standard of truth.~   "
255286|NCT00209378|"~     The purpose of this study is to compare citrate regional anticoagulation with systemic~     heparinization in continuous venovenous hemofiltration. The investigators' hypothesis is,~     that regional citrate anticoagulation with replacement solution containing trisodium citrate,~     will be associated with lower mortality and less bleeding complications compared to heparin,~     with also a better filter survival.~   "
255334|NCT00208715|"~     The main purpose of this study is to determine if Provigil® (modafinil) at a dose of 200 mg~     once daily is safe and effective for treating symptoms of sleepiness and fatigue associated~     with Major Depressive Disorder when added to a SSRI.~   "
255287|NCT00209365|"~     The aim of the study is to explore the contribution of pollen starch granules to the induced~     symptoms and airway inflammation in patients with allergic rhinitis and mild asthma in a~     controlled pollen exposure(pollen challenge room at the Fraunhofer ITEM). Starch granules are~     released from the pollen grains and are considered to be the allergen carriers of the pollen.~     The hypothesis is proposed that pollen starch granules are important in the induction of~     airway inflammation and airway hyperresponsiveness.~   "
255288|NCT00209352|"~     The objective of this study is to prevent reactivation of herpes zoster during the first year~     after transplant.~   "
255289|NCT00209339|"~     Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System~     (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month,~     12 month, and 5 year clinical follow-up.~   "
255290|NCT00209326|"~     • To determine the effects of four different single bolus doses of FE200440 administered~     intravenously on stopping preterm labour compared to placebo in pregnant women with advanced~     gestational age~   "
255291|NCT00209313|"~     The study proposed that both clinical and subclinical HSV reactivation is associated with~     increased HIV shedding from mucosal surfaces, which may increase the infectiousness of~     HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation~     with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV~     levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir~     will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.~   "
255292|NCT00209300|"~     This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation~     will be done centrally. The patients will be treated for 1 year, with clinical and laboratory~     assessments at 0, 4, 8 and 12 months.~      Endoscopic examination is at enrollment and on completion of the study (at relapse or after~     12 months).~      Number of Subjects (Planned and Analysed):~        -  360 patients for demonstration of non-inferiority between once daily and twice daily;~        -  326 to be analysed in per-protocol (PP) analyses; and~        -  360 in intention-to-treat (ITT) analyses.~   "
255293|NCT00209287|"~     Male or female, 18 years of age or older. Ulcerative Colitis described according usual~     criteria, diagnosed for at least 1 year. Oral maintenance treatment with 5-aminosalicylic~     acid (5-ASA) only for at least 3 months with a dosage of 2 to 3 g/day. Clinical remission for~     at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo~     Clinic) at the inclusion. Signed informed consent form.~   "
255294|NCT00209274|"~     EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study~     of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients~     to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a~     prospective multi-center study of the MitraClip System for the treatment of mitral valve~     regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A~     continued access prospective, multi-center study (REALISM) of the MitraClip System in a~     surgical population (non-high risk arm) and a high surgical risk population (high risk arm)~     is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high~     risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month,~     12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually~     for 5 years.~   "
255295|NCT00209261|"~     To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with~     Minirin® tablet treatment after 6 weeks.~      To compare efficacy of the 2 formulations at the end of the 6-week treatment period using~     diary card data.~      To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a~     PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2~     formulations~   "
255296|NCT00209235|"~     We, the researchers, are following the natural history of Albright hereditary osteodystrophy.~     We have found that growth hormone deficiency is very common in patients with~     pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright~     hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short~     and obese. Some of these patients are not short during childhood, but due to a combination of~     factors, they end up short as adults. We are evaluating the effect of growth hormone~     treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth~     hormone deficient or those who are growth hormone sufficient and were found to have a~     positive clinical response to growth hormone in a prior clinical trial under R01 FD003409,~     IND 67148 or those who meet the criteria of idiopathic short stature or SGA.~      We are also evaluating neurocognitive and psychosocial functioning in participants with AHO~     in order to determine the specific impairments that are most common in the condition and to~     determine the best approach toward management.~      Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01~     FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864~   "
255297|NCT00209222|"~     The aim of this study is to determine whether alternating courses of cyclophosphamide,~     doxorubicin, vincristine, prednisone/dexamethasone, cytarabine, cisplatin (CHOP/DHAP) plus~     rituximab followed by total body irradiation [TBI]/high dose cytarabine~     [ARA-C]/melphalan-peripheral blood stem cell transplantation (TAM-PBSCT) can improve the time~     to treatment failure compared to CHOP plus rituximab followed by standard PBSCT~     (dexamethasone, carmustine, cytarabine, etoposide, and melphalan [Dexa-BEAM]/TBI/high dose~     cyclophosphamide) in patients with untreated mantle cell lymphoma.~   "
255298|NCT00209209|"~     The aim of this study is to answer the following independent questions in the treatment of~     mantle cell lymphomas:~        -  Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma~          mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone~          (R-CHOP) and so become a new standard for initial cytoreductive therapy?~        -  Can maintenance with rituximab substitute the interferon maintenance and even improve~          the progression free survival in patients after successful initial cytoreductive~          therapy?~   "
255335|NCT00208702|"~     This study will evaluate the effectiveness of treatment with supplemental triiodothyronine~     (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in~     improving symptoms of major depressive disorder (MDD).~   "
255520|NCT00206232|"~     The purpose of the study is to collect information about the potential benefit and safety of~     low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine~     whether spironolactone can cause the patient's condition to improve.~   "
255299|NCT00209196|"~     Adherence to medical regimens refers to what degree a patient chooses to follow the advice~     given by his/her healthcare provider. Good adherence typically involves behaviors such as the~     patient taking medication as directed and going to scheduled clinic appointments. As many~     patients often do not follow the advice of doctors as closely as suggested, many researchers~     have tried to find out the reasons behind patients being non-adherent. This research has~     looked at medical conditions such as diabetes, cystic fibrosis, and asthma. More recently,~     researchers have started to look at adherence with children who have undergone solid organ~     transplantation. This is because about 50% of these children are to some degree non-adherent~     with their medical regimen. This comes at a costly price as ongoing non-adherence in~     pediatric transplant can lead to the child's body rejecting the new organ and even death.~     This study has been designed to look at the reasons that pediatric patients may choose to be~     non-adherent. This study will look at issues related to the patient (e.g., age, family~     support), related to the disease and regimen (e.g., length of illness, how complicated the~     regimen is), related to the medication (e.g., taste, side effects), related to their mind~     (e.g., memory problems, confusion), and related to their emotions (e.g., being depressed,~     anxious). The investigators will be looking at each regimen-related behavior, such as~     attending clinic appointments and will be asking each family about any barriers that make it~     difficult. The investigators hope that knowing these barriers will help them make~     interventions that fit the specific issues that each patient faces. Ultimately, doctors,~     transplant coordinators, and psychological professionals will be able to use this information~     to intervene early with families who report barriers that impact adherence.~   "
255300|NCT00209170|"~     African-Americans suffer from increased prevalence of both type 2 diabetes and diabetes~     complications, reflecting a combination of psychobehavioral factors as well as metabolic~     dysfunction. In this process, depression may contribute to both the genesis of type 2~     diabetes (through impact on neurohormonal activation, inflammatory mediators, and insulin~     resistance), and difficulties in management (through decreased adherence to diet plans,~     medication, and scheduled appointments). The preliminary data from the Grady Diabetes Clinic~     indicates that depression may be common in African-Americans with diabetes, that depression~     is a factor in non-adherence, and that non-adherence leads to poor glycemic control - a~     direct cause of diabetes complications. What is not known is: how treatment of depression~     could lead to both neurohormonal and psychobiological improvement, with improved patient~     adherence and glycemic control.~   "
255301|NCT00209144|"~     The purpose of this study is to determine if intense control of high glucose levels in~     patients treated with angioplasty for heart attack has anti-inflammatory and anti-thrombotic~     effects.~   "
255302|NCT00209131|"~     The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining~     if the medication Flomax will result in improved stone passage rates following SWL.~   "
255303|NCT00209118|"~     A.OVERVIEW~      This is a 26 week study examining the ability of paroxetine (Paxil) to prevent the~     development of depression and neurotoxicity in patients receiving either 3 million units of~     subcutaneous IFN(interferon-alpha-2b) 3 times/week (plus ribavirin, 1000-1200 mg/d)) or PEG~     (polyethylene glycol) interferon-alpha-2b (1.5 micrograms/kg one time a week) and ribavirin~     (800 to 1,400 mg a day) for chronic hepatitis C (CHC). The IFN plasma half life (t1/2 of 24~     to 34 hours) of PEG, a CHC treatment recently approved by the FDA, is significantly prolonged~     allowing for once a week dosing. Studies indicate that the side effect profile of the two~     forms of IFN-alpha treatment are very similar. CHC patients will be screened for study~     eligibility, and a total of 100 CHC patients between the ages of 18 and 65 years old will be~     enrolled across three sites (30 at Emory site and a combination of 30 from the University of~     Pennsylvania, Rush-Presbyterian-Saint Lukes Medical Center in Chicago and Montefiore Medical~     Center in New York.) Two weeks prior to treatment with subcutaneous IFN-alpha-2b, patients~     who meet inclusion and exclusion criteria will be stratified on the basis of a history of~     major depression and then randomly assigned to paroxetine or placebo in double blind fashion.~   "
255304|NCT00209105|"~     This study will characterize the mental health consequences of early-life trauma.~   "
255305|NCT00209092|"~     The purpose of this study is to find out if the combination of docetaxel and capecitabine can~     shrink the size of breast tumors and preserve the breast.~   "
255306|NCT00209079|"~     The purpose of this trial is to test the combination of Gleevec® (also known as imatinib~     mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer.~     This study is being performed to see if the combination of Gleevec and Taxotere is an~     effective treatment for incurable stomach cancer with minimal side effects.~   "
255307|NCT00209066|"~     The purpose of this study is to evaluate alterations in sympathetic tone in patients with~     major depression with and without ischemic heart disease and then to reevaluate these~     patients after 8 treatments with electroconvulsive therapy(ECT). We expect to support the~     hypothesis that HRV are pathophysiologically associated with the state of major depression.~     We hypothesize the following:~        1. Heart rate variability (HRV) will be decreased prior to treatment of depression in~          comparison to post-treatment measures of HRV.~        2. After 8 treatments with ECT, HRV will be increased under basal conditions.~   "
255308|NCT00209053|"~     The purpose of this study is to determine completeness of revascularization, graft patency,~     clinical outcomes, health-related quality of life and costs in 200 initial trial participants~     at > 5 years post surgery who had heart bypass surgery with heart-lung bypass (on-pump) or~     without heart-lung bypass (off-pump). The hypothesis is that the patency of coronary artery~     bypass grafts of off-pump surgery are no less durable than grafts from conventional on-pump~     surgery.~   "
255309|NCT00209040|"~     The current study will investigate the ability of people with and without fear symptoms after~     trauma to inhibit fear in an experimental situation.~   "
255310|NCT00209027|"~     The objective of this study is to determine whether subjects with negative symptoms of~     schizophrenia have abnormal functioning of brain circuits relevant to reward processing, and~     to determine whether any such abnormalities are normalized by treatment with aripiprazole.~   "
255311|NCT00209014|"~     Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part~     in this study. The purpose of this study is to find out what effects (good and bad) the drug~     thalidomide has on patients and the lymphoma.~   "
255312|NCT00209001|"~     The purpose of this study is to determine if acupuncture is effective in relieving hot~     flashes in women treated with hormonal therapy for breast cancer.~   "
255345|NCT00208572|"~     The proposal will assess the effectiveness of SRI treatment of anxiety following TBI. We~     hypothesize that participants will report significantly fewer and less severe anxiety~     symptoms after a 12-week course of citalopram than after a 12-week course of placebo.~   "
255346|NCT00208559|"~     The purpose of this study is to see if the drug, ziprasidone, is effective in treating~     problems in adolescent associated with autism.~   "
255313|NCT00208988|"~     Prostate cancer is the most common type of cancer among men. It is also the second leading~     cause of cancer-related death among men. Two screening tests are available to try to detect~     prostate cancer early – the digital rectal examination (DRE) and the prostate specific~     antigen (PSA) blood test. Unfortunately, physicians aren’t sure whether or not these two~     screening tests help save lives, and there’s a lot of controversy about how to use them.~     Recently, a major government committee (the U.S. Preventive Services Task Force) recommended~     that physicians discuss the risks and potential benefits of prostate cancer screening with~     their patients, and allow patients to make their own decision.~      Because of the controversies, many physicians currently don’t discuss prostate cancer with~     their patients. The problem is that it takes time and effort to have these discussions, and~     the information is complicated. A lot of patients have trouble understanding it, especially~     if they have a limited educational background or trouble reading. When patients have~     difficulty obtaining, understanding, and acting on basic health information, we say that they~     have “low health literacy.” Other researchers have shown that patients with low health~     literacy don’t know as much about cancer screening and are less likely to get screened for~     various cancers. They also tend to be timid about discussing things with their doctor, and~     often go along with what the doctor says, rather than taking an active role in the decision~     making.~      In 2003, under IRB approval, we conducted a study with 2 goals: 1) to encourage patients to~     talk to their doctor about prostate cancer screening, and 2) to learn more about the impact~     of low health literacy on these conversations. To promote conversation, we used two handouts,~     given to patients in the waiting room before they saw the doctor. The first was a patient~     education handout about prostate cancer screening, written in very simple terms with useful~     illustrations. The second was a handout that simply encouraged patients to talk to their~     doctor about prostate cancer. Patients got one of the two handouts, or a nutritional handout~     that served as a control. After they saw their doctor, a research assistant briefly~     interviewed the patient to find out whether or not prostate cancer screening was discussed.~     We also measured the patients’ health literacy skills, and asked a few other questions about~     their decision to get screened for prostate cancer.~   "
255314|NCT00208975|"~     Patients with a low-grade, or indolent (slow-growing) form of non-Hodgkin's lymphoma (NHL) in~     which the usual survival is between 7-10 years are being asked to take part in this study.~     Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40% of~     patients (called complete response or complete remission), almost all will have their disease~     return.~      In this study, researchers tested a combination of anti-cancer agents, fludarabine, rituximab~     and GM-CSF with mitoxantrone or cyclophosphamide to see if a better and more long-lasting~     response can be achieved. All of the medications are approved by the Food and Drug~     Administration (FDA) and are available on the market. The agents we will use are:~        -  Mitoxantrone and fludarabine and cyclophosphamide and fludarabine are combinations of~          chemotherapy drugs that have been successfully used to treat NHL/CLL (Chronic~          lymphocytic leukemia) that has returned after treatment and are comparable options for~          treatment.~        -  Rituximab, a monoclonal antibody that kills cancer cells by binding the CD20 antigen~          found on the surface of B-cells, commonly used along with chemotherapy drugs to improve~          response rates in lymphoma treatment.~        -  GM-CSF (granulocyte-macrophage colony stimulating factor, also called sargramostim, GM,~          or Leukine), a growth factor which stimulates the development of new (stem) cells.~          GM-CSF encourages stem cells to divide, specialize, and become active. It is not a~          normal part of treatment for NHL.~      Using GM-CSF in NHL treatment is the experimental part of this study. The main purpose of~     this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work~     better to reduce cancer, and to look at side effects of the treatment.~   "
255315|NCT00208962|"~     This is a research study involving the treatment of leukemia or lymphoma (lymph gland cancer)~     in adults who have leukemia or lymphoma that is unlikely to be cured with regular anticancer~     drugs or radiation treatments.~   "
255316|NCT00208949|"~     This is a study involving patients who are undergoing allogeneic peripheral blood stem cell~     transplantation. Both donors and recipients are being sought for this study.~   "
255317|NCT00208936|"~     This study is designed pre-operative for patients with resectable, local-regional carcinoma~     of the esophagus.~   "
255318|NCT00208923|"~     Patients who have cancer of the bone marrow (leukemia) or lymph gland (lymphomas) are being~     asked to take part in this study. This study uses a new chemotherapy regimen and matched~     volunteer stem cell transplant to treat patients with cancers of this kind.~   "
255319|NCT00208910|"~     A novel procedure for generalized anxiety disorder where an odorant cue is paired with the~     state of deep relaxation during training. It is hypothesized that by smelling the odor in an~     anxiety-provoking situation, the patient will more easily invoke a state of relaxation,~     providing greater relief from the distressing tension and worry that characterize GAD.~   "
255320|NCT00208897|"~     The primary objective of this project is to determine whether treatment with the SSRI,~     fluoxetine versus placebo reverses alterations in the central CRF system induced by early~     life stress experiences (i.e. childhood sexual and/or physical abuse) in cases with and~     without major depression. We also evaluate whether neuroendocrine changes after SSRI~     treatment correlate with clinical improvement.~   "
255321|NCT00208884|"~     One of the risks associated with heart transplantation is failure of the graft. A graft is~     where the new heart is attached to the original vessels in the body. Approximately 10% of~     children suffer graft failure which, leads to heart failure and possible death. The problem~     is that we do not know some of the causes of graft failure thus, it is difficult to diagnose~     early and treat. Due to graft failure, lots of children are placed back on the transplant~     list and receive another new heart.~      In this study, we plan to perform a retrospective chart review looking to see if we can~     correlate graft failure with a problem with the vessels called coronary allograft~     vasculopathy or rejection. In order to do this, we will collect data from patient's charts~     that have been diagnosed with graft failure and compare their clinical presentation/data to~     pathology reports of the explanted hearts from these children. Explanted hearts are the old~     transplanted hearts that are removed in order to put a new heart into the body. Explanted~     hearts at our institution are always sent to pathology for analysis thus it will be quite~     easy to perform this review.~   "
255322|NCT00208871|"~     The primary goal of this study is to compare, within a clinical screening setting, the~     performance of stereoscopic digital mammography with standard (non-stereo) digital~     mammography in the detection of abnormalities in the breast, including early breast cancer.~   "
255323|NCT00208858|"~     The purpose of this study is to gather pilot data to determine feasibility of and guide the~     development of a larger clinical trial investigating the effects of topiramate as an adjunct~     to nicotine replacement therapy and behavioral counseling in smoking cessation treatment. It~     is hypothesized that topiramate will decrease nicotine craving and result in improved~     outcomes for smoking cessation.~   "
255324|NCT00208845|"~     Identify untreated, asymptomatic hypertension in ER patients~   "
255519|NCT00206245|"~     The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and~     75 mg).~      The secondary objectives are to compare the efficacy between the three doses of AZD0865 and~     esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.~   "
255325|NCT00208832|"~     Coronary heart disease (CHD) is the most common cause of death in the United States. A common~     term for CHD is blocked arteries. People with CHD or blocked arteries often have high~     blood pressure, high cholesterol, or diabetes. They are also more likely to suffer a heart~     attack. Many heart attacks could be prevented by taking medicines that control blood~     pressure, cholesterol, and diabetes. However, only 50%-60% of patients take their medicines~     as directed. Patients who don't take their medicines regularly are considered noncompliant.~      One of the risk factors for noncompliance is low health literacy. Health literacy is the~     ability to obtain, understand, and act on basic health information. Patients with low health~     literacy may not understand their illnesses as well, or how to take their medicines properly.~      The purposes of this project are~        1. to learn more about the relationship between low health literacy and medication~          compliance, and~        2. to test 2 different strategies designed to help patients take their medicines more~          regularly.~      Patients with CHD were recruited when they arrived for a regular doctor's appointment. We~     measured their health literacy skills, asked questions about how they take their medications,~     and checked their blood pressure and last cholesterol and diabetes measurements. We then~     assigned patients to 1 of 4 intervention groups (intervention ongoing). The first group is~     receiving usual care, which includes regular medication instructions printed on the bottle~     and no reminders to refill medicines. The second group gets monthly postcards reminding them~     to refill their prescriptions. The third group gets a new medication schedule that shows~     them, with pictures and figures, how they are supposed to take their medicines each day. The~     fourth group receives both the postcards and the new medication schedule. We are following~     patients for 1 year to see which intervention has the greatest impact on their medication~     compliance, blood pressure, cholesterol, and diabetes measurements. We will also examine~     whether patients' health literacy affects the success of the interventions.~   "
255326|NCT00208819|"~     The purpose of this study is to determine whether an antipsychotic medication alone or an~     antipsychotic medication in combination with divalproex is the most effective and safest way~     to treat agitation in elderly patients with dementia.~   "
255327|NCT00208806|"~     Pacemakers can be attached to one or more than one of the heart chambers. After watching~     pacemakers work over time, doctors have found that the pacemakers that stimulate only one~     chamber of the heart sometimes lead to problems later. These problems may be changes in the~     size and shape of the heart. The heart cannot work as well when some of these changes happen.~     We need to learn more about these changes and how to prevent them. There has not been an easy~     way to do this. A new treatment called Cardiac Resynchronization Therapy (CRT) is associated~     with biventricular pacing where two chambers of the heart are stimulated simultaneously.~     Tissue Doppler Imaging,Tissue Synchronization Imaging and 3 dimensional echocardiography are~     new forms of technology that look at the heart while it works. They are similar to a moving~     x-ray that can watch the heart muscles moving. The movement can be measured. Doctors will~     check for changes that happen over time. This has not been studied in children before because~     this kind of is new to this group of patients. This technology is noninvasive which means it~     can be done from the outside of the body and is painless.~      The hearts of children grow fast. It is important to be able to know if the pacemaker or~     problems from dilated cardiomyopathy are causing any changes in the heart that might cause~     problems. We expect to be able to use information we learn from this study to improve how we~     use pacemakers in the future to avoid problems that can happen over time.~   "
255328|NCT00208793|"~     The purpose of this study is to test whether calcium and/or vitamin D supplementation~     favorably affects a set of biomarkers of risk for colon cancer in persons who are at higher~     than average risk for colon cancer (ie, have already undergone the removal of adenomatous~     polyps, which are known to be precursors to developing colon cancer).~   "
255329|NCT00208780|"~     Tetrahydrobiopterin (BH4) is a cofactor for the nitric oxide (NO) synthase enzymes, such that~     its insufficiency results in uncoupling of the enzyme, leading to release of superoxide~     rather than NO in disease states, including hypertension. We hypothesized that oral BH4 will~     reduce arterial blood pressure (BP) and improve endothelial function in hypertensive~     subjects. Oral BH4 was given to subjects with poorly controlled hypertension (BP >135/85 mm~     Hg) and weekly measurements of BP and endothelial function made. In Study 1, 5 or 10 mg kg−1~     day−1 of BH4 (n=8) was administered orally for 8 weeks, and in Study 2, 200 and 400 mg of BH4~     (n=16) was given in divided doses for 4 weeks~   "
255330|NCT00208767|"~     The EFFERVESCENT trial is designed to evaluate the effects of a specific ARB, called~     valsartan, on atherosclerosis. The investigators want to know if treatment with valsartan~     will increase the blood levels of markers responsible for repair of the vessel wall, reduce~     oxidation and inflammation, improve the function of the blood vessels, and arrest or slow~     down the progression of atherosclerosis over time.~   "
255331|NCT00208754|"~     In today's world of advanced surgery, children born with congenital heart disease (CHD) are~     surviving into adulthood. However, the surgical procedures these children undergo do not cure~     the underlying problem and this these children develop other heart problems later in life.~     Heart failure is the one of the most common heart problems effecting these patients. This~     heart failure can be seen in both lower pumping chambers of the heart, however, sometimes~     only one side of the heart is affected. Since there are several congenital heart defects that~     are now seen in the adult population, an understanding of what causes heart failure in this~     patient population can help physicians develop better treatments for this condition. The goal~     of this study is to review the medical records of 350 adult patients with congenital heart~     disease that has developed heart failure. During this review, we plan to collect information~     regarding the various treatments utilized in these patients and to determine if there are any~     common elements regarding the development of heart failure in adult patients with CHD.~   "
255332|NCT00208741|"~     The main purpose of this study is to determine how safe and effective Gabitril is for~     outpatients with Social Anxiety Disorder (SAD).~   "
255333|NCT00208728|"~     During open-heart surgery, blood flow is supported by a heart-lung machine that both pumps~     the blood and gives it oxygen. A problem associated with a heart-lung machine is the damage~     to some of the blood caused by protein in the blood cell sticking to the sides of the~     heart-lung machine tubing. This breakdown of the blood cell affects the platelets, which help~     the blood to clot. Use of the un-treated circuit will be phased out within the next few~     years, as newer technology is available. The use of coated tubing has been shown to decrease~     problems with post-operative bleeding in the adult population. No studies have been done on~     the pediatric population. We plan to perform a prospective, randomized study using the~     un-treated circuits used now, the  Smart circuit tubing manufactured by Cobe Cardiovascular~     Inc., Arvada, CO and the PMEA circuit manufactured by Terumo Corporation, Tokyo, Japan.~     Randomization will be performed by the perfusionist (the person that runs the heart-lung~     machine) in charge of the case. No one else will be aware of which circuit is being used.~     There will be no changes in the operation of the heart-lung machine, anesthesia or the~     surgery because of this study.~      Blood testing that is standard of care and some additional tests will be performed on a small~     amount of blood drawn from. the patient via arterial lines. Additional blood sticks will not~     be required to obtain this sample.~   "
255336|NCT00208689|"~     Congenital heart disease in infants and children often challenges healthcare providers both~     in regards to diagnosis and in the management of these conditions. The field becomes more~     complicated as one examines the myriad of defects that present and the complex care that is~     required. Over the last 20-25 years, the remarkable advances in the medical and surgical~     management of the most complex lesions have decreased neonatal mortality, such that many more~     survive the neonatal period. Therefore, new challenges regarding the continued care of this~     patient cohort of high-risk infants and children exist. In order to continue the improvement~     of treatment(s) offered to these patients, continuous review and analysis of the current~     standard of care is needed.~      In this study, the investigators will collect information related to the current surgical and~     medical therapies offered to patients enrolled in the High Risk Congenital Heart Program at~     Children's Healthcare of Atlanta. All of the procedure and visit information will be a part~     of the child's standard of care. This information will be placed in a database. The~     investigators hope to learn more about the short-term and long-term effects of current~     therapies and procedures.~   "
255337|NCT00208676|"~     There are many children that have heart dysfunction because they are either born with~     Congenital Heart Disease (CHD) or developed poor heart function because their hearts are ill.~     The invention of medical technology helps in the treatment of these children. New heart~     echocardiogram (echo) techniques including Tissue Doppler (TDI), Tissue Synchronization~     Imaging (TSI) and 3 dimensional echocardiography (3D) are imaging technologies that we hope~     will help in the diagnosis and treatment of these children.~      Tissue Doppler Imaging is a noninvasive technique that measures the speed of heart muscle~     movement. Tissue Synchronization Imaging measures how well the lower pumping chambers of the~     heart are working together. A 3D echo is a 3 dimensional picture of a beating heart that~     allows your doctor to see the heart from any angle. These techniques are noninvasive, meaning~     on the outside of your body. The size and function of the ventricles (the lower part of the~     heart) can change under different conditions. Using these techniques we will attempt to~     better determine how well the ventricles function during illness and health.~   "
255338|NCT00208663|"~     The purpose of this study is to determine if a simple 'pick-list' menu applied to a handheld~     computer's time-motion program can be used to record reliably what a hospital-based doctor~     does while working a shift in the hospital. In this study reliability will be measured by~     comparing the data collected by at least two different observers recording data from the same~     hospitalist during the same period of time.~   "
255339|NCT00208650|"~     There are many children born with Congenital Heart Disease. Many of these children have to~     undergo surgical procedures to correct the problem. Some patients must eventually get a new~     heart. Once they get a new heart, we have to have ways to determine how well the new heart is~     doing inside of the body. Tissue Doppler Imaging is one way of doing so. Tissue Doppler~     Imaging is like an ultrasounds. It takes pictures of the heart. In addition to Tissue Doppler~     Imaging, there is a newer non-invasive procedure called Tissue Synchronization Imaging which~     will allow us to see how well the new heart is working as well. In this study we would use~     both techniques to determine how well the new heart is working.~   "
255340|NCT00208637|"~     High protein diets are popular among Maori, especially on the East Coast of the North Island.~     The purpose of this study was to compare the metabolic effects of a moderate carbohydrate,~     high protein diet (MCHP) with a high carbohydrate-high fibre (HCHF) diet on insulin~     sensitivity in Maori at increased risk of developing diabetes and cardiovascular disease.~   "
255341|NCT00208624|"~     We would like to conduct a retrospective chart review examining the incidence of surgical~     heart block in children treated in the Cardiac Service Line at Children's Healthcare of~     Atlanta. We would like to look at the last 30 surgical heart block cases seen at Children's~     Healthcare of Atlanta. We will collect the following information on each patient:~      Patient Date of Birth Date of the surgical procedure~      Weight of the patient at the time of surgery Concomitant Diagnoses Need for permanent~     pacemaker Outcome of pacing (i.e. pacing successful)~      We hope to look at each data element in order to determine potential risks factors for~     surgical heart block. By identifying the risk factors, the investigator hopes to establish a~     training program regarding surgical avoidance of certain areas of the heart (if possible) and~     education regarding pacemaker follow-up.~      Each patient will be given a unique study number. The patient's name, social security number,~     medical record number or initials will not be used in our research database.~   "
255342|NCT00208611|"~     Based on Parkinson's disease (PD)/vitamin B12 deficiency symptom overlap and PD patients'~     propensity to avoid protein (the dietary source of vitamin B12), this study proposes to~     prospectively investigate the vitamin B12 status of PD patients over time. In addition, this~     study will provide critical pilot data evaluating the efficacy of treating those patients~     considered to have below-normal vitamin B12 levels in serum. Further, it will also explore~     the concept that supplementing PD patients having low-normal vitamin B12 levels with~     vitamin B12 improves either the non-motor PD symptoms or homocysteine levels in PD patients~     receiving levodopa.~      Study Hypotheses:~        1. Serum cobalamin (B12) concentrations in patients with Parkinson's disease (PD) are~          significantly lower than B12 concentrations in a) cohabiting spousal caregiver controls;~          and b) population-based, age-matched controls.~        2. Supplementation with B12 in levodopa-treated PD patients with low (<200 pg/ml) or~          low-normal (200-300 pg/ml) serum B12 levels is associated with significant improvement~          in their non-motor symptoms and reduces total plasma homocysteine concentration [Hcy], a~          known biomarker for risk of dementia and cerebrovascular disease.~   "
255343|NCT00208598|"~     It has been proposed that a higher cut off for BMI (body mass index) is to be used in Maori~     to define overweight and obesity. However, no one has assessed the prevalence of co-morbid~     conditions associated with BMI. It is well known that Maori are at greater risk of diabetes~     and cardiovascular disease compared to non-Maori and a delay in the identification of those~     who are overweight and obese may be detrimental for Maori. We will assess BMI, other measures~     of adiposity and prevalence of co-morbid conditions with a comparison with a similar matched~     non-Maori population.~   "
255344|NCT00208585|"~     The purpose of this study is to investigate the efficacy of an SSRI, sertraline for the use~     of post-concussive symptoms following a traumatic brain injury. the study also seeks to~     investigate the relationship between irritability and aggression and anosmia in individuals~     who have suffered a traumatic brian injury.~   "
255347|NCT00208546|"~     This is a study to assess the efficacy and safety of the addition of cetuximab to the~     combined regimen of capecitabine, oxaliplatin and bevacizumab in patients with previously~     untreated advanced colorectal carcinoma. It is an open, comparative study, comparing the~     effects of capecitabine, oxaliplatin and bevacizumab to those of the same regimen plus~     cetuximab.~      Seven hundred fifty patients will be included. Treatment will continue until disease~     progression or serious toxicity and follow up will continue until death. It is anticipated~     that the addition of cetuximab will lead to an increase in progression free survival.~   "
255348|NCT00208533|"~     This is a 6-week open pilot study of aripiprazole for the treatment of adolescents, aged 12~     to 18 years, diagnosed with autism.~      Children who qualify for the study will be treated with aripiprazole for 6 weeks.~      Treatment is provided at no cost.~   "
255349|NCT00208520|"~     Most patients are prescribed valproate as their first antiepileptic drug. It is unknown which~     is the best second-line drug when patients do not become seizure free on valproate. This has~     led the Dutch Epilepsy Clinics Foundation (SEIN) to start the SLICE study. Adult patients~     with partial and/or tonic-clonic seizures, insufficiently responding to valproate, are~     recruited for this study. These patients are randomized to receive one of three other drugs.~     Patients wil initially use this drug next to valproate. Neurologists of more than 20 general~     hospitals en neurologists of SEIN are participating in this study.~   "
255350|NCT00208507|"~     The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic~     liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head~     and a polyethylene liner.~   "
255351|NCT00208494|"~     The purpose of this study is to compare the performance of artificial hips with metal heads~     and metal sockets to artificial hips with ceramic heads articulating with metal socket~     components. The success of the total hip arthroplasty (THA) will be based upon all of the~     following clinical and radiographic criteria being met at the two-year evaluation: (1) the~     patient's clinical results as measured using modified Harris Hip evaluation rating system,~     and the absence of a complication that requires the surgical removal or replacement of a~     component; and (2) radiographic findings at study endpoint (i.e., two years follow-up).~     Clinical and radiographic success at two (2) years postoperative is required for the study~     hip to be deemed successful.~   "
255352|NCT00208468|"~     This post-market clinical follow-up study was designed to compare hip replacement outcomes of~     the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex~     did not end up being used. The first patient had surgery on February 18, 2000 and the final~     patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had~     hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48~     Spotorno). The study took place at three sites. Each site used their standard device as the~     control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips~     and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59~     European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the~     data collected by the sites did not include these outcomes.~   "
255353|NCT00208455|"~     The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the~     treatment of patients with hip joint disease requiring a total hip replacement. Patients who~     enter the study will be evaluated at regular intervals following hip surgery using patient,~     clinical and x-ray assessments. A subset of patients will undergo scans to allow the bone~     mineral density of the bone surrounding the implant to be monitored~   "
255354|NCT00208442|"~     The purpose of this study is to compare the performance and compare the wear characteristics~     of two polyethylene cup liners, Marathon™ and Enduron™, in the treatment of patients with hip~     joint disease requiring a total hip replacement. Patients who enter the study will be~     randomly allocated to one of the polyethylene cup liners, Marathon™ or Enduron™ and will be~     evaluated at regular intervals using clinical and x-ray assessments.~   "
255355|NCT00208429|"~     The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a~     polyethylene-on-metal bearing combination in the treatment of patients with hip joint disease~     requiring a total hip replacement. Patients who enter the study will be evaluated at regular~     intervals following hip surgery using patient, clinical and x-ray assessments.~   "
255356|NCT00208416|"~     The purpose of this study is to compare the short-term outcomes of two surgical techniques,~     minimally invasive and conventional, when used in the treatment of patients with hip joint~     disease requiring a total hip replacement. Patients who enter the study will be randomly~     allocated to undergo surgery using the minimally invasive or conventional surgical technique~     and will be evaluated at regular intervals following hip surgery using patient, clinical and~     x-ray assessments with a focus on short term rehabilitation.~   "
255357|NCT00208403|"~     The purpose of this study is to monitor the stability of a total hip replacement within the~     thigh bone when used in artificial hip joints implanted with two different bone cements,~     Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a~     total hip replacement. Patients who enter the study will be randomly allocated to Acryloc™ or~     Palacos® R and will be evaluated at regular intervals following hip surgery using patient,~     clinical, x-ray assessments and special x-rays which allow the stability of the hip implant~     to be determined~   "
255358|NCT00208390|"~     The purpose of this study is to monitor the performance of the Summit™ hip in the treatment~     of patients with hip joint disease requiring a total hip replacement. Patients who enter the~     study will be evaluated at regular intervals following hip surgery using patient, clinical~     and x-ray assessments.~   "
255374|NCT00208182|"~     This medical study is an assessment of clinical response in women with Posttraumatic Stress~     Disorder (PTSD) due to domestic violence or rape trauma when treated with risperidone.~     Response to risperidone or placebo (inactive drug) is measured by Clinician Administered PTSD~     Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8). Second, the effect of risperidone on~     depressive and anxiety symptoms will be assessed using the Hamilton Rating Scale for Anxiety,~     Hamilton Rating Scale for Depression and the Clinical Global Impression.~   "
255489|NCT00206648|"~     The purpose of this study is to determine the difference in preventing a relapse between~     Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized~     into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be~     converted to Betaseron standard dose.~   "
255359|NCT00208377|"~     The purpose of this study is to monitor the performance and determine the metal ion release~     of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip~     resurfacing surgery. Patients who enter the study will be evaluated at regular intervals~     following hip surgery using patient, clinical and x-ray assessments. A subset of patients~     will also have blood samples taken at regular intervals to allow the metal ion levels to be~     determined and undergo scans to allow the bone mineral density of the bone surrounding the~     implant to be monitored.~      DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from~     December 2010 to allow for the completion of the 5 year follow up assessments.~      Please note that subsequent to this decision DePuy voluntarily recalled the ASR products on~     24 August 2010. Additional information regarding this voluntary recall and the follow-up of~     patients affected by the recall can be found at the following links~     http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157 and~     http://www.depuy.com/countries_list.~   "
255360|NCT00208364|"~     The purpose of this study is to monitor the performance and determine the metal ion release~     of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients~     with hip joint disease requiring a total hip replacement. Patients who enter the study will~     be evaluated at regular intervals following hip surgery using patient, clinical and x-ray~     assessments. A subset of patients will also have blood samples taken at regular intervals to~     allow the metal ion levels to be determined.~   "
255361|NCT00208351|"~     The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX~     hip stem in the treatment of patients with hip joint disease requiring a total hip~     replacement. Patients who enter the study will be randomly allocated to one of the 4 designs~     of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip~     surgery using patient, clinical and x-ray assessments.~   "
255362|NCT00208338|"~     Primary Endpoints:~      Comparative evaluation of any differences between the two groups in change from baseline to~     the 3-month time point in terms of:~        -  Functional recovery (patient-based) - using the Oxford Shoulder Score.~        -  Functional recovery and early return of strength (pain, activities of daily living~          [ADL], range of motion [ROM], and power) - evaluated using the Constant Shoulder~          Assessment.~        -  Functional recovery (pain and function - patient-based), evaluated using the American~          Shoulder and Elbow Surgeons (ASES) Shoulder Assessment - patient self-report section.~        -  Region-specific Quality of Life - using the Western Ontario Rotator Cuff (WORC) Index.~        -  Range of motion - assessed by goniometer recorded as part of the Constant Score.~        -  Pain (taken from Pain visual analog scale [VAS] of the ASES Shoulder Assessment); and~        -  Record of escape pain medication usage (recorded in a daily patient diary).~      Secondary Endpoints:~      Comparative evaluation of any difference between the two groups in change from baseline to~     the 6-week time point, in terms of:~        -  Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain~          medication usage (recorded in a daily patient diary).~      Comparative evaluation of any differences between the two groups in change from baseline to~     the 6-month time point, in terms of:~        -  Functional recovery (patient-based) - using the Oxford Shoulder Score.~        -  Functional recovery and early return of strength (pain, ADL, ROM, and power) - evaluated~          using the Constant Shoulder Assessment.~        -  Functional recovery (pain and function - patient-based), evaluated using the ASES~          Shoulder Assessment - patient self-report section.~        -  Region-specific Quality of Life - using the Western Ontario Rotator Cuff Index.~        -  Range of motion - assessed by goniometer recorded as part of the Constant Score.~        -  Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain~          medication usage (recorded in a patient diary).~      Comparative evaluation of any difference between the two groups in change from baseline to~     the 6-week, 3, 6 and 12 month time points, in terms of health status - assessed by the EQ-5D~     instrument.~   "
255363|NCT00208325|"~     The primary objective of this investigation is to evaluate the performance (in terms of~     post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma~     Rotating Platform total knee systems in clinical practice.~   "
255364|NCT00208312|"~     Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to~     thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The~     investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist,~     the receptor responsible for coronary vasodilation, and is being studied for potential use as~     a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will~     compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible~     myocardial perfusion defects.~   "
255365|NCT00208299|"~     Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to~     thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The~     investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist,~     the receptor responsible for coronary vasodilation, and is being studied for potential use as~     a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will~     compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible~     myocardial perfusion defects.~   "
255366|NCT00208286|"~     This post-market clinical follow-up study was designed to compile long-term knee replacement~     outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The~     first patient had surgery on November 8, 2001 and the final patient had surgery on July 29,~     2005. There were 120 knees consented by a single site, which was the planned sample size in~     the study protocol, with 117 receiving one of the study devices. The study was terminated as~     the primary outcome was met and the investigator decided to conduct the study without sponsor~     support after 2009.~   "
255367|NCT00208273|"~     This trial will compare grade 2 or greater late skin toxicities of concomitant~     letrozole-radiotherapy and radiotherapy followed by letrozole as adjuvant therapy for~     postmenopausal women with receptor (estrogen receptor [ER] and/or progesterone receptor~     [PgR]) positive tumors. Each drug will be prescribed for 5 years.~   "
255368|NCT00208260|"~     Randomized, open label, multicentre phase II trial followed by phase III comparing overall~     survival after having selected the best experimental arm.~   "
255369|NCT00208247|"~     The purpose of this study was to examined if psychotherapy is an effecitive treatment for~     hypochondriasis.~   "
255370|NCT00208234|"~     The purpose of this study is to determine if Xolair can reduce the abnormal increase in~     limitation to airflow in patients with asthma in a relatively short time period. Another~     purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an~     asthmatic patient in the same time period.~   "
255371|NCT00208221|"~     The purpose of this study is to determine if a dose of ramipril combined with a normal dose~     of telmisartan 80 mg will be more effective than ramipril 20 mg in reducing microalbuminuria~     in hypertensive patients with diabetes.~   "
255372|NCT00208208|"~     Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which~     are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone~     (Geodon), suggests possible anxiolytic and antidepressant properties. This research will~     assess the potential effectiveness of Geodon in civilian men and women who suffer from severe~     PTSD. Response to ziprasidone or placebo will be measured by Clinician Administered PTSD~     Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).~   "
255373|NCT00208195|"~     The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in~     the treatment of patients with bipolar disorder in the manic phase, who also have comorbid~     substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young~     Mania Rating Scale and the Substance Abuse Time Line Follow Back.~   "
255375|NCT00208169|"~     It is hypothesized that the use of aripiprazole (Abilify) in patients with alcohol and/or~     drug dependence with comorbid psychiatric conditions will lead to:~        -  Reduction in the amount of alcohol and/or drugs used as measured by the Time Line Follow~          Back (TLFB) and the Addiction Severity Index (ASI)~        -  Reduction in cravings for alcohol and drugs as measured by the Penn Alcohol Craving~          Scale~        -  Reduction in symptoms of co-morbid psychiatric disorders compared to before starting~          aripiprazole.~   "
255376|NCT00208156|"~     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called~     cortisol. Under normal conditions, cortisol and other hormones are created by the body in~     response to physical and emotional stress, triggering a healthy stress response. People who~     suffer from psychotic major depression may have unusually high levels of cortisol circulating~     within them or abnormal patterns of cortisol levels, overloading the stress response~     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If~     Corlux can keep the body's cortisol receptors from being overloaded, the stress response~     system may return to normal function, which may result in improvement of symptoms. The~     purpose of this study is to allow patients who have already participated in an earlier 8 week~     study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment~     with Corlux periodically if a psychotic episode should reappear during a period of one year.~   "
255377|NCT00208143|"~     It is hypothesized that the atypical antipsychotic, Seroquel, will cause significant~     reduction in drug and alcohol cravings in patients with schizophrenia and comorbid cocaine~     and/methamphetamine dependence compared to the atypical antipsychotic, risperidone~     (Risperdal).~      Patients treated with Seroquel will have less use of cocaine and/or methamphetamine as~     measured by the Time Line Follow-back, over a 24-week follow-up period.~   "
255378|NCT00208130|"~     The primary objective of this study is to investigate the safety and efficacy of topiramate~     in the treatment of PTSD in women survivors of domestic violence and/or rape trauma as~     measured by the Clinician-Administered PTSD Scale (CAPS) for DSM-IV.~   "
255379|NCT00208117|"~     The purpose of this study is to examine the relationship between depressive symptoms and~     markers of inflammation, two predictors of heart disease.~   "
255380|NCT00208104|"~     The purpose of this project is to study ways to make it more likely that patients will take~     their blood pressure medicine as recommended by their doctors.~   "
255381|NCT00208091|"~     This study uses a computerized method of musical instrument digital interface (MIDI)~     quantification of performance before and after treatment with botulinum toxin type B (Myobloc~     ®, Solstice Neurosciences). Myobloc is a purified and diluted form of botulinum toxin used~     medically to relax unwanted muscle spasms and movements. The aim of the study is to determine~     the feasibility of quantifying change in performance following treatment.~   "
255382|NCT00208078|"~     There is no randomised controlled trials to determine the clinical effects of long term~     Non-Invasive Ventilation in Cystic Fibrosis patients.~   "
255383|NCT00208065|"~     The primary objective of this study is to evaluate histamine, CGRP and VIP levels in saliva~     as biological markers for activation of trigeminal and parasympathetic nerve fibers in~     various clinical presentations of primary headaches compared to allergic rhinosinusitis and~     control populations.~   "
255384|NCT00208052|"~     The purpose of the pilot study is to validate an assesment tool to be used in the assessment~     of pain in the verbal, congitively intact patient. The ultimate goal is to be able to~     validate this tool in the non-verbal/cognitively impaired patient.~   "
255385|NCT00208039|"~     A research study that will evaluate if giving surfactant medication to premature babies~     weighing < 1250 gm at birth during the second and third weeks of life will help their lungs.~     We are enrolling those premature babies who continue to require the breathing tube and the~     mechanical ventilator at days 7-10 of life.~   "
255386|NCT00208026|"~     Netherton syndrome is a genetic condition that can result in abnormal skin functioning.~     People with this condition often have red and scaling skin; sparse or short hair; and~     problems with absorption of medicines or chemicals that are applied to the skin. If these~     chemicals are absorbed at a high level, they may cause health problems. Elidel (pimecrolimus)~     is a new medicine that is available as a cream. It has been shown to help improve the~     appearance of the skin in patients with another skin condition known as atopic dermatitis,~     and is approved by the United States (US) Food and Drug Administration for use in children~     with mild to moderate atopic dermatitis. The purpose of this study is to determine if Elidel~     is safe, to see whether the medication is absorbed through the skin, and to see if side~     effects are associated with its use in children with Netherton syndrome.~   "
255387|NCT00208013|"~     Cachectic patients often lose their appetite, lose weight, and are prone to weakness and even~     death in advanced illness. Nutrition therapy is important and of concern to the investigators~     in cancer patients. More than 80% of terminal cancer or advanced illness patients get~     cachexia. Cachexia is a complex, multifactorial syndrome that results from a reduction in~     food intake, a variety of metabolic abnormalities (including hypermetabolism) or more often a~     combination of the two. Cachexia will progress with disease progression. Cachexia or weight~     loss is often the major cause of death or poor quality of life.~      The change of resting energy expenditure (REE) is different in various tumor types. Most~     experts agree that the REE will increase in cancer cachexia syndrome. The more weight loss,~     the more cachexia will occur.~      Overnutrition is not beneficial in terminal patients according to the Chiu and Easson~     studies. As the investigators know, few studies focus on REE in terminal patients. In this~     study, samples are from a hospice palliative ward or from hospice home care patients in a~     medical center in mid-Taiwan. About 100 patients will be recruited. The investigators will~     analyze the relationship between REE and its related factors. After finishing the study, they~     will provide more evidence for treating cachexia in terminal patients.~   "
255388|NCT00208000|"~     Hyperuricemia is a common metabolic disorder.The Yaizu Suisankagaku Industry Company have~     developed industrial production named Marine Active, was able to offer anti-fatigue activity~     by animal trial data. Human clinical trials showed reduced creatine phosphokinase activity~     and a sero-uric acid reduction activity was also observed. So we are committed to design the~     clinical randomized, double blind study about hyperuricemia management with Marine Active.~     All these efforts are hoped to find a novel method to manage hyperuricemia.~   "
255389|NCT00207987|"~     This is a study using cerebral oximetry to evaluate the safety of traditionally adopted~     hypotensive anesthesia.~   "
255390|NCT00207974|"~     Hyperuricemia is often associated with metabolic syndrome, which is a known precursor of~     atherosclerosis. The Yaizu Suisankagaku Industry Company have developed industrial~     production, named Marine Active. Human clinical trials showed reduction of creatine~     phosphokinase activity and sero-uric acid. Randomize, double blind clinical trial is entrust~     to our hospital. This study design is blood sampling from the health men who take 1 gm of~     marine active to analyse the pharmacokinetics of anserine.~   "
255391|NCT00207961|"~     Using patients receiving spinal anesthesia as a model to evaluate the treshold value of~     cerebral oximeter to detect the symptoms of cerebral ischemia~   "
255392|NCT00207948|"~     This was a feasibility study aimed at elevating protease inhibitors (PI) dosage as a part of~     active antiretroviral therapy (HAART). After the pharmacokinetics for the currently~     prescribed PI were determined,patients with a vIQ<1 were eligible for a 50% dose increase for~     an 8 week time frame after which their vIQ would be reassessed to determine if increasing~     their PI dosage thereby increasing the bioavaiability would reduce their viral load.~   "
255393|NCT00207935|"~     This study is being done to see if children with learning problems can learn how to swallow~     pills without chewing them. The reason this is important is that if a person has seizures,~     medications must be taken every day. Most medications need to be taken 2 or 3 times per day.~     Some medications have slow release and only are taaken once per day. Medications with slow~     release usually come in capsule form and cannot be opened or chewed. This study investiates~     whether children with developmental delay can be taught how to swalow pills.~   "
255394|NCT00207922|"~     The purpose of this study is to see the correlation of polarization and the expresison of~     chemokine receptors of T help cells after allogeneic hematopoietic stem cell transplantation~     and clinical course graft-versus-host disease.~   "
255395|NCT00207909|"~     Acute kidney failure is common in children in the Pediatric Intensive Care Unit (PICU). You~     are being asked to participate in this study because your child is being treated for kidney~     failure with continuous veno-venous hemofiltration (CVVH). CVVH is a continuous, gentle form~     of removing excess fluids and small wastes from the blood, similar to kidney dialysis~     (artificial kidney). It is an accepted therapy for temporary support of kidney failure. In~     some patients with acute kidney failure, beginning CVVH is followed by a temporary decrease~     of urine output. The reason why this happens is currently unknown. The purpose of this study~     is to determine why this happens.~   "
255396|NCT00207896|"~     Research studies in adults have shown that certain hormones may be decreased or may not work~     normally which contributes to how sick a person becomes. The purpose of this project is to~     study hormones in children. The investigators will look to see if a decrease of certain~     hormone levels affects how sick a child may become. This study is intended to develop a~     connection between hormone levels and severity of illness. It is hoped that the information~     gathered will help develop further studies that may more clearly explain the role of hormones~     in critically ill children and possibly the introduction of hormone replacement in critical~     illness.~   "
255397|NCT00207883|"~     The purpose of this study is to see how fast and accurate two different techniques used by~     physicians to insert catheters in children are. Catheters are tiny tubes which carry fluids,~     blood and sometimes liquid food into a person's vein. The technique currently used relies on~     the physical landmarks and using fingers to feel the anatomy in which to place the catheter~     in the vein or artery. The investigators are changing to a technique where they will use~     ultrasound at the patient's bedside to help physicians with placing the catheter into the~     blood vessel. They are comparing the use of these two methods to determine which is faster~     and requires fewer needle sticks.~   "
255398|NCT00207870|"~     Supracondylar fractures are the most common elbow fractures in children. In the current~     orthopedic literature crossed pinning and lateral-only entry techniques are co-gold standards~     of operative treatment. The crossed pinning technique has been shown to be biomechanically~     superior especially under torsional loading but has a higher incidence of iatrogenic injury~     to the ulnar nerve. All studies comparing these techniques to date have been either~     biomechanical or retrospective in nature. A randomized, controlled, prospective study~     comparing these two popular techniques has not been performed.~      The purpose of this study is to prospectively evaluate the amount of displacement incurred~     when treating type III supracondylar humerus fractures in children with crossed pinning~     versus lateral-entry only technique. Overall complication rate, loss of reduction, iatrogenic~     neurovascular injury, and pin tract infection rates between the two cohorts will be~     evaluated. The study population will comprise all patients less than ten years of age~     presenting to Scottish Rite Hospital during the study period with a type III supracondylar~     fracture managed by the Children's Healthcare of Atlanta Orthopedic Group. All patients will~     be randomized to one specific treatment arm based on surgeon preference established at the~     onset of the study. The hypothesis to be tested is that no difference in amount of~     displacement or overall complication rate is present between these two techniques.~     Radiographic parameters measured pre-operatively, immediately post-operatively and four weeks~     post-operatively will be quantitatively evaluated and compared. Chart reviews to determine~     complications during the treatment period will be made. Pre-study power analysis and~     post-study statistical analysis will be performed.~   "
255399|NCT00207857|"~     Nearly all patients with Duchenne's Muscular Dystrophy (DMD) have scoliosis. Posterior~     instrumented spinal fusion, which is a surgery to correct scoliosis, has been shown to~     improve quality of life and satisfaction of both parents and families. The progressive~     muscular weakness leads to the development of scoliosis soon after the child has become~     unable to walk. The muscular weakness and scoliosis also affect the pulmonary function of~     these children. Pulmonary Function Tests (PFT) have been used to determine pulmonary~     fitness prior to surgery as a way to determine how well or if the child will tolerate~     surgery. Children with poor results on the PFT are determined to be too fragile to tolerate~     such a large operation. The physicians conducting this study feel that the PFT may be~     inaccurate and that this may not be the best single test to determine pulmonary fitness.~     The physicians conducting the study think things like the time of day the study is done, how~     tired you are when you complete the test, and how well you understand the test may affect the~     results of the test.~   "
255484|NCT00206713|"~     The purpose of this study is to evaluate whether treatment with Leukine in patients with~     Crohn's disease who have previously responded to Leukine can be helped again, once they have~     relapsed.~   "
255400|NCT00207844|"~     Septic shock is a frequent syndrome with a 45% mortality rate despite intensive care unit~     (ICU) care, where free radicals may play a key role, and a >40% decrease in plasma selenium~     concentration is observed. Selenium is a trace element with both indirect enzymatic~     anti-oxidant, and direct oxidant properties. High dose of sodium selenite administration~     could increase antioxidant cells capacities, and reduce inflammation by a direct paradoxical~     pro-oxidative effect. We conduct a study to evaluate the effects of selenium treatment in~     comparison to placebo, in septic shock patients. Efficacy will be evaluated by the weaning~     time of catecholamines.~   "
255401|NCT00207831|"~     RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing and~     also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells.~     5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil~     is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation~     therapy before surgery may shrink the tumor so it can be removed.~      PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in~     treating patients who are undergoing surgery for operable rectal cancer.~   "
255402|NCT00207818|"~     The aim of the study is to evaluate the effect of a biological dressing on the healing~     process of venous ulcers. The dressing is a reconstructed skin substitute made with the~     patients own cells.~   "
255403|NCT00207805|"~     Autologous peripheral blood stem cell (PBSC) transplantation is now considered standard~     therapy in patients (< 65 ans) with multiple myeloma. The Intergroupe Francophone du Myelome~     conducted a randomised trial of the treatment of multiple myeloma with high dose chemotherapy~     followed by either one or two successive autologous stem cell transplantation. The~     probabilities of event-free-survival and overall survival were doubled with a double~     transplant. The benefits were greatest among patients who had not had a very good partial~     response to the first transplant.~      The aim of this multicenter randomised trial in previously untreated patients with multiple~     myelome (stage II, III DS)is to assess the optimal timing of a second autologous stem-cell~     transplant.After a first-line therapy with thalidomide-dexamethasone followed by a PBSC~     collection, patients are randomly assigned to receive two autologous PBSC transplants (arm~     A)or one autologous PBSC transplant followed by a consolidation therapy with~     thalidomide-dexamethasone (arm B). Patients included in the arm B will receive a second~     transplant in case of disease progression on consolidation therapy, or in case of relapse in~     responders.~   "
255404|NCT00207792|"~     The effect of haematopoietic growth factors on neutrophil recovery after allogeneic bone~     marrow transplantation is well recognized. Recent laboratory studies demonstrated that these~     cytokines may also modify T-cell and dendritic cell function, but whether the effect is~     strong enough to alter the risk of graft-versus-host disease (GvHD) is unclear.~      The aim of this randomised study is to determine the effect of granulocyte colony-stimulating~     factor [G-CSF] (Neupogen; filgrastim) on the risk of acute GvHD after allogeneic bone marrow~     transplantation.~   "
255405|NCT00207779|"~     We, the researchers at Centre National de Greffe de Moelle Osseuse, have shown in a~     randomised study (in press), that a low dose of unfractionated heparin (100 IU/kg/daily) was~     safe and effective to prevent catheter-related bloodstream infection in patients with~     haemato-oncological disease.~      The aim of this prospective randomised controlled trial is to compare the incidence of~     catheter-related bloodstream infection in 2 groups of patients with haemato-oncological~     disease:~        -  Group A: heparin impregnated catheters~        -  Group B: low-dose unfractionated heparin (100 IU/kg/daily)~   "
255406|NCT00207766|"~     A study of infliximab in patients with Fistulizing Crohn's Disease~   "
255407|NCT00207753|"~     The aim of this study is to compare the efficacy and impact on growth of two drug treatments~     against intestinal worms in schoolchildren from a rural area of Guatemala. According to the~     World Bank, these intestinal worms are one of the top causes of childhood health problems in~     many areas of the developing world (The World Bank, 1993). Infected children are more likely~     to have inadequate nutrition due to the worm infections and are more likely to be shorter in~     height and weigh less than children who are not infected. After collecting height and weight~     information, we will split the children into two groups. One group will receive albendazole~     and the other group will receive combined albendazole/ivermectin. Both groups will be~     receiving albendazole, the current standard of care treatment. Ivermection is expected to~     improve efficacy and nutritional benefit as well as add increased scope of treatment for the~     worm Strongyloides, and ectoparasites such as scabies and head lice. Both treatment regimens~     and the combination have been used millions of times in the developing world and are safe to~     use. Co-administration of drugs would be a more efficient use of the opportunity to access~     schoolchildren and provide deworming treatment.~   "
255408|NCT00207740|"~     The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab)~     in patients with severe persistent asthma.~   "
255409|NCT00207727|"~     The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients~     with Multiple Sclerosis~   "
255410|NCT00207714|"~     Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to~     assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at~     either 2- or 4- week intervals in subjects with active RA despite MTX therapy.~   "
255411|NCT00207701|"~     A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with~     Ankylosing Spondylitis~   "
255412|NCT00207688|"~     The purpose of this study is to evaluate long-term safety information of infliximab in~     patients who have participated in infliximab clinical studies in ulcerative colitis.~   "
255413|NCT00207675|"~     A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with~     moderate to severe Crohn's Disease~   "
255414|NCT00207662|"~     This is a study of infliximab (Remicade) in subjects with Crohn's disease~   "
255485|NCT00206700|"~     The purpose of this study is to establish a safety profile sargramostim administered in 8~     week cycles to adult patients with active Crohn's disease.~   "
255490|NCT00206635|"~     The purpose of this follow-up study is to look carefully at the long-term course of multiple~     sclerosis (MS) and possibly the long-term effects of Betaseron in the patients who were~     previously enrolled in the original North American study that led to the marketing approval~     of Betaseron.~   "
255415|NCT00207649|"~     Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective~     study of educational interventions to improve the interaction of physicians and their~     patients about prostate cancer screening. Educational material is provided in primary care~     practices using either standard paper information or a novel web-based interactive curriculum~     that explores the risks and benefits of screening measures for prostate cancer for older men.~     The impact of the intervention on shared decision-making with both actual and standardized~     patients will be assessed.~   "
255416|NCT00207636|"~     The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for~     use by men considering PSA screening for prostate cancer. Major medical organizations~     recommend that men discuss the risks and benefits of this test with their physician before~     making the decision. This educational, interactive DA will help them prepare for that~     discussion.~   "
255417|NCT00207623|"~     While there are a variety of arthritis education materials available, the evidence-base on~     most of them is slim, so it i impossible to know what benefits they may have for the people~     who participate. The purpose of this project is to evaluate the effectiveness of the~     mail-delivered self-management education program, Arthritis Basics for Change (ABCS) with an~     emphasis on changes in knowledge, beliefs, behavior, self efficacy and health outcomes, and~     to evaluate the appropriateness, usefulness, and readibility of the program. This project~     will assist CDC's Arthritis Program in determining the usefulness of the ABCs program for~     helping people with arthritis improve their quality of life.~   "
255418|NCT00207610|"~     Anemia is common among low-income women after they have given birth. Anemia, or low~     hemoglobin in the blood cells, is usually caused by not having enough iron. Blood cells~     usually carry oxygen to other parts of the body. Without enough hemoglobin, the ability of~     blood cells to carry oxygen is decreased. Memory and work may be impaired. The purpose of~     this study is to evaluate three methods of giving iron to prevent anemia among low-income~     women after they have given birth.~   "
255419|NCT00207597|"~     This study examines the progression of joint disease in children with hemophilia assigned to~     either standard treatment or enhanced therapy.~   "
255420|NCT00207584|"~     This study was designed to determine whether taking daily doxycycline during an outbreak of~     Mycoplasma pneumoniae could prevent a person from getting infected and interrupt ongoing~     disease transmission during an outbreak. Doxycycline is a treatment for Mycoplasma~     pneumoniae, but it is not certain that the drug could prevent disease if used~     prophylactically.~   "
255421|NCT00207571|"~     To help public health professionals (DIS) in interviews of patients infected with STD for the~     names of their sex partners, this project used a computer-based partner elicitation program~     before the actual DIS interview. The main outcome was the mean number of partners named by~     those who had the intervention versus those those who did not.~   "
255422|NCT00207558|"~     The aim of this study is to examine whether the same total daily dosage of folic acid, when~     taken as a single daily dose or as multiple divided doses throughout the day, results in~     different blood folate and homocysteine levels at the conclusion of the study. Further, a~     comparison of blood folate and homocysteine levels among women taking daily low-dosage~     (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly~     high-dosage (4000mcg) folic acid will be conducted.~   "
255423|NCT00207532|"~     CDC staff at the National Center on Birth Defects and Developmental Disabilities have been~     working closely with a Honduras-based organization, Project Healthy Children (PNS) and the~     Ministry of Health, on a folic acid supplementation study among female maquila workers.~     Participants are divided into two groups. One group receives a 1.0 milligram pill daily while~     the other group receives a 5.0 milligram pill weekly. The aim of this study is to assess~     serum blood folate levels measured at baseline, midpoint, and endpoint of the study.~     Hypothesis: Folic acid (5mg)given once weekly is as effective as folic acid (1mg)given daily~     in raising blood folate levels.~   "
255424|NCT00207519|"~     In this 3-month pilot study, we will introduce to 40 adolescents at risk for overweight~     (i.e., a BMI/age >85th percentile) a structured meal plan consisting of meal replacements,~     fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and~     invite at least one parent to the scheduled visits, however, no subject will be eliminated~     because of lack of parental involvement. In this study, we will conduct behavior modification~     group sessions using lessons which are structured and patterned after the suggestions~     documented in the LEARNÒ Program for Weight Control. Diet instruction by a registered~     dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie~     meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan~     will be developed by the dietitian for subjects to follow.~      Subjects will return on a weekly basis for behavioral modification groups sessions in~     conjunction with the liquid meal replacement diet. Blood work and physical examinations will~     occur pre and post intervention.~   "
255425|NCT00207506|"~     Non-professional community leaders may be at a great advantage in reaching otherwise hard to~     reach populations for the purpose of advising on sexually transmitted disease (STD)~     prevention (lay health advisors), health care access, and model health behavior. Latino~     migrant farm workers are at increased risk for STD and might benefit from such lay health~     advisors. The study will examine whether this strategy is a useful one for STD prevention in~     Latino migrant farm workers in rural and small town areas of North Carolina.~   "
255426|NCT00207493|"~     Patients diagnosed with chlamydial infections (a sexually transmitted disease) are asked to~     notify their sex partners and tell them to seek medical evaluation. This project tests an~     enhancement to the materials provided to patients to help convince their partners to seek~     evaluation against the standard of care, which is a brief notification instruction. The~     desired outcomes are greater levels of notification by participants of their partners and~     lower levels of reinfection among participants.~   "
255427|NCT00207480|"~     This study will implement and test a brief, tailored individual-level intervention to be used~     in two New Orleans adolescent clinics with female patients aged 16-24 who douche.~   "
255428|NCT00207467|"~     The goal of this study was to examine the efficacy of patient-delivered partner treatment~     (PDPT) compared to standard partner referral (PR) and booklet enhanced partner referral~     (BEPR).~   "
255429|NCT00207454|"~     This research tests the effectiveness of a social cognitive intervention (with option of~     patient-delivered medication) geared toward increasing patient referral of partners.~   "
255430|NCT00207441|"~     The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease~     Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other~     chronic diseases. In some locations it may be more feasible to combine efforts and offer the~     generic course rather than the arthritis-specific program. However anecdotal evidence has~     questioned whether people with arthritis obtain as much benefit from the more generic course~     as they do the arthritis-specific course. The primary purpose of this research studies is to~     compare health outcomes among people with arthritis who participate in either ASHC or the~     CDSMP. The North Carolina project is focusing primarily on African Americans from 6 rural~     counties in North Carolina. The results of this research will be used to guide Arthritis~     program recommendations on the use of ASHC and CDSMP to improve the quality of life for~     people with arthritis.~   "
255431|NCT00207428|"~     The purpose of this study was evaluation the efficacy of antiepileptic drug carbamazepine in~     the treatment of mild-to-severe bronchial asthma.~   "
255432|NCT00207415|"~     The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease~     Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other~     chronic diseases. In some locations it may be more feasible to combine efforts and offer the~     generic course rather than the arthritis-specific program. However anecdotal evidence has~     questioned whether people with arthritis obtain as much benefit from the more generic course~     as they do the arthritis-specific course. The primary purpose of this research study is to~     compare health outcomes among people with arthritis who participate in either ASHC or the~     CDSMP. The University of Illinois Project is emphasizing recruiting a balance of uran and~     rural participants. The results of this research will be used to guide Arthritis program~     recommendations on the use of ASHC and CDSMP to improve the quality of life for people with~     arthritis.~   "
255433|NCT00207402|"~     Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during~     treatment) or relapsed (virus went away on treatment but came back after treatment was~     stopped) after treatment with at least twelve weeks of a pegylated (long-acting) interferon~     and ribavirin will be considered for this study. There are two purposes to this study: first,~     to determine how rosiglitazone, a medicine used to treat diabetes, affects the HCV viral~     load; and second, to determine if treatment of insulin resistance with rosiglitazone prior to~     therapy for HCV will improve sustained virologic response (loss of virus that continues~     beyond six months after completion of HCV therapy) to HCV therapy.~   "
255434|NCT00207389|"~     Obesity is a multinational epidemic. There is evidence that despite educational measures and~     increased public awareness, the number of obese individuals continues to increase. Of the~     numerous obesity-related comorbidities, type 2 diabetes remains one of the most significant~     in terms of mortality and health care costs. Gastric Bypass Surgery (GBS) not only offers an~     effective form of therapy for morbid obesity, but also amelioration of type 2 diabetes~     mellitus. The normalization of glucose levels in GBS patients occurs within days after~     surgery and has been shown in surgical literature to be independent of the weight loss after~     surgery. The proximal gut, the site of release of certain incretins, may play a role in~     glucose homeostasis in obese individuals with type 2 diabetes mellitus. One such incretin is~     GIP, which when released into the circulation during the immediate postprandial period,~     accentuates the insulin response to a glucose meal. It is hypothesized that overactivity of~     this enteroinsular axis in obese individuals produces cell resistance to insulin and~     subsequent type 2 diabetes mellitus. A previous study reported elevated fasting GIP levels,~     as well as an exaggerated GIP response to a glucose meal, in obese subjects, which was~     significantly reduced months after GBS following weight loss. This pilot study of obese~     patients scheduled for GBS will compare the serum levels of certain peptides, including GIP,~     following a glucose meal before and after GBS, before weight loss has occured. In order to~     reproduce the preoperative state, and therefore to demonstrate the physiologic change, a~     small group of subjects who undergo open surgery will undergo the same measurements after~     surgery, but using a model in which the meal traverses the stomach, duodenum and jejunum with~     the aid of a gastrostomy tube.~   "
255435|NCT00207376|"~     This is a prospective multicenter clinical study to evaluate the safety and effectiveness of~     an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent~     foramen ovale (PFO).~   "
255436|NCT00207363|"~     The purpose of this study is to see which of two doses of PEG (polyethylene glycol)~     interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at~     elimination of hepatitis C.~      The primary objective of this study is to compare the efficacy of Induction PEG-Interferon~     alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron)~     and Ribavirin (Rebetol) in patients with chronic hepatitis C.~   "
255437|NCT00207350|"~     The researchers' specific aims are to test the following hypotheses:~      Hypothesis 1: A tumor can be completely ablated by ILT with MRI-guidance.~      Hypothesis 2: The MRI-based 3D temperature map of tissue during ILT is predictive of~     destruction.~      Hypothesis 3: The 3D thermal dose map that is based on the tissue's temperature over time~     is more predictive of tissue destruction than the temperature map.~   "
255438|NCT00207337|"~     Current treatment for emphysema is limited to measures that include inhaled oxygen,~     bronchodilators, anti-inflammatory drugs and pulmonary rehabilitation. Highly invasive~     procedures such as lung volume reduction surgery or lung transplantation are also performed.~     Treatment using the Exhale Drug-Eluting Stent (DES) is a minimally invasive bronchoscopic~     treatment that has the potential to reduce shortness of breath in emphysema patients. This~     study tests the safety and effects of Exhale DES in the treatment of patients with emphysema.~   "
255439|NCT00207324|"~     The hypothesis is that silver leaf nylon dressing reduces the percentage of patients~     developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy.~     The secondary hypothesis is that silver leaf nylon dressing reduces breast-related symptoms~     of pain, itching and burning sensation in patients receiving whole breast radiotherapy.~   "
255440|NCT00207311|"~     This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with~     histological evidence of > 33% hepatic steatosis or nonalcoholic steatohepatitis (NASH) and~     chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment~     naive) will be enrolled.~   "
255521|NCT00206219|"~     This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer~     in terms of overall survival.~   "
255441|NCT00207298|"~     Positron emission tomography (PET) is a nuclear medicine procedure based on the measurement~     of positron emission from radiolabelled tracer molecules. These radiotracers allow biologic~     processes to be measured and whole body images to be obtained which demonstrates sites of~     radiotracer accumulation. The most common radiotracer in use today is 18F-fluorodeoxyglucose~     (18F-FDG) which is a radiolabelled sugar (glucose) molecule. Imaging with 18F-FDG PET is used~     to determine sites of abnormal glucose metabolism and can be used to characterize and~     localize many types of tumours.~      Cancer treatment and outcome depend largely on the accurate diagnosis and staging of disease.~     There is extensive data in the literature indicating the importance of FDG-PET imaging in~     accurately characterizing disease, as well as determining stage and sites of recurrent~     disease in many cancer types. For these indications, functional imaging with PET provides~     unique information which is not available from standard medical imaging modalities such as~     ultrasound, X-ray, computerized tomography (CT) or magnetic resonance imaging (MRI).~      The objectives of this study are to document the safety and efficacy of 18F-FDG produced by~     the British Columbia Cancer Agency (BCCA) at its Tri-University Meson Facility (TRIUMF)~     production facility and to evaluate FDG-PET as a diagnostic and decision making tool in the~     management of oncology patients in British Columbia. With a population base of over 4 million~     people, standardized cancer treatment protocols, and evidence based guidelines for FDG-PET~     imaging, the BCCA is positioned to make an important contribution to defining the role of PET~     in the Canadian health care system.~   "
255442|NCT00207285|"~     The purpose of the study is to test the effect of a sleep disorders detection and treatment~     program for police officers on their safety, quality of life, and job performance. The~     program is called Operation Healthy Sleep. We will develop and test a sleep health detection~     and treatment program that we aim to apply nationwide to reduce police officer fatigue and~     stress; enhance the ability of officers and their families to cope with police work; improve~     the health, safety and performance of law enforcement officers; and thereby improve public~     safety. Part of this program will include a questionnaire asking about about work hours and~     health related issues. We will then look at how these survey data relate with data on police~     officer safety and job performance that we are collecting through police department's~     databases.~      Sleep disorders are common and treatable, but often remain undiagnosed and untreated. Police~     officers work some of the most demanding schedules known, which increases their risk of sleep~     disorders. The public expects officers to perform flawlessly, but unrecognized sleep~     disorders lead to severe disruption of sleep, which significantly reduces an individual's~     ability to think clearly and perform well. In addition, sleep loss and sleep disruption~     affect personal health, increasing the risk of gastrointestinal and cardiovascular. We also~     know that sleep loss increases the risk of injury due to motor vehicle crashes.~      The goals of Operation Healthy Sleep are to improve officers' health, safety, and performance~     by reducing the impact of fatigue.~      The study will take place over two years. In the first year, half of the police officers will~     take part in Operation Healthy Sleep, and in the second year, the second half will~     participate. We will carefully select the year 1 and year 2 groups so that the data collected~     across the two years can be validly compared.~   "
255443|NCT00207272|"~     Twelve obese patients approved for gastric bypass surgery will be randomized to either~     receive an MCT-based or LCT-based liquid diet for a 4 week period. These diets will be~     identical except for the quality of the fat. The intervention will be double-blinded. Six~     patients will receive a daily diet consisting of 5 liquid meals using the HMR 800 meal~     replacement product (Health Management Resources, Inc; 160 calories/shake) with 44.5 grams~     MCT oil (Life Enhancement Products, Inc., Petaluna, CA; 8.3 kcal/gm) added. Six patients will~     receive the same HMR diet but with 41 grams LCT oil (corn oil; 9 kcal/gm) added. Patients in~     both groups will be given a list of supplemental foods that are suitable for the study. They~     may choose to eat up to an additional 700 kcal per day from this list and will be asked to~     complete food records for monitoring of their caloric intake. Patients will undergo gastric~     bypass surgery after 4 weeks of being on their diets. Patients in both groups will be seen~     weekly by a registered dietitian and a physician. Blood pressure and weight will be recorded,~     and any adverse events will be noted and cared for as is appropriate. Dietary instruction~     will be reviewed as needed.Both diets will be 1170-1870 kcal/day, consisting of 36% CHO,~     26.2% protein, and 37.6% fat. The MCT diet will contain 30.2% of total calories at MCT oil.~     The percentages given are based on the shake and oil consumption only (1170 kcal/day). The~     remainder of the diet will vary according to patients' selections from the list of permitted~     foods, up to an additional 700 kcal/day (for the total 1870 kcal/day). All subjects will~     receive a multi-vitamin each day. Subjects will also receive two Fibercon capsules per day to~     prevent possible bowel changes associated with being on a full liquid diet. During surgery,~     biopsies of visceral and omental adipose tissue, as well as subcutaneous abdominal adipose~     tissue, will be obtained. Tissue will be analyzed to determine mRNA levels of key enzymes in~     fatty acid esterification, lipolysis, and oxidative disposition. This preliminary phase will~     be conducted to determine whether visceral, omental, and subcutaneous abdominal adipose~     tissue behave similarly when exposed to an MCT-based diet.~   "
255444|NCT00207259|"~     Randomized clinical study of two CAM therapies, 1) Reiki and 2) Relaxation Response Therapy~     with Cognitive Restructuring counseling (RRT with CR), compared to an education-only control~     arm in patients about to begin an eight-week course of external beam radiotherapy (EBRx) for~     prostate cancer.~      Generally, we would like to examine the feasibility of studying Reiki and RRT with CR in~     patients with prostate cancer, and to obtain preliminary results on the effectiveness of~     these treatments compared to controls.~      Specific objectives:~        1. Determine the proportion of eligible patients who agree to participate in the study~        2. Measure compliance with CAM therapy interventions~        3. Measure compliance with physiologic and psychological outcome measurement assessments~        4. Assess differences between experimental and control groups on measures on depression,~          anxiety, quality of life, salivary cortisol levels and an immunomarkers~   "
255445|NCT00207233|"~     Phase I, 6 weeks: Intensive weight loss 42 obese subjects with type 2 diabetes mellitus or~     impaired fasting glucose (FBS greater than 100 mg/dl) and a patient at the Nutrition and~     Weight Management Center at Boston Medical Center will be randomized to receive either an~     MCT-based or LCT-based liquid diet for a 6 week period (Phase I) to establish compliance~     followed by a second 6 week period (Phase II). These diets will be isocaloric (1083 kcal/day)~     and identical except for the quality of the fat. The intervention will be double blinded. The~     MCT diet will consist of 5 liquid meals using a commercial product plus 34 grams MCT oil~     (Life Enhancement Products, Inc. Petaluna, CA; 8.3 kcal/gm) added per day to the HMR shakes.~     The LCT diet will utilize 5 HMR shakes plus 31.5 grams LCT oil (corn oil; 9 kcal/gm) per day.~     Patients in both groups will be given a list of supplemental foods that are suitable for the~     study. They may choose to eat up to an additional 400 kcal per day from this list and will be~     asked to add these to their food records for monitoring of their caloric intake. A dietitian~     will instruct subjects at a baseline visit on behavior modification and a moderate physical~     activity program. Baseline testing includes the following: Body composition by DEXA~     (Hologic); Subcutaneous abdominal adipose tissue biopsy; blood work. Subjects who do not lose~     5% of their baseline weight by the end of Phase I will be withdrawn from the study. If~     subjects do not lose 5% in Phase I, they will be considered inappropriate for a liquid diet,~     and therefore for the study, and will be discontinued from the study.~      Phase II, 6 weeks: Continued weight loss program during phase II, subjects will be maintained~     on the same diet, supplements and exercise program. Once patients enter Phase II, all~     baseline lab measurements will be repeated. Needle biopsies of subcutaneous abdominal adipose~     tissue will be obtained at the beginning and at at the end of Phase II. Finger-stick blood~     glucose levels will be checked weekly. At the end of Phase II, and of the study, fasting~     blood work will be obtained. At the end of Phase II, the following procedures will be~     performed: Subcutaneous abdominal adipose tissue biopsy (total = 3). Body composition by DEXA~     (Hologic) (total = 2).~   "
255446|NCT00207220|"~     This study will test the hypothesis that increases in ventricular-vascular stiffness can be~     demonstrated by arterial tonometry and echocardiography in subjects with heart failure with~     preserved ejection fraction (HF-nlEF)(i.e. normal left ventricular function.) We will also~     track changes in pulsatile hemodynamics over time in subjects hospitalized with HF-nlEF.~   "
255542|NCT00205946|"~     The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL~     (bupropion hydrochloride) on reward processing.~   "
255447|NCT00207207|"~     The objective is to assess the effect of using ASBG (alternate site blood glucose) versus~     FTBG (finger tip blood glucose) testing on long-term glycemic control in diabetics. Since~     ASBG measurements appear to lag behind FSBG measurements at times of changing glucose~     concentration, it is possible that ASBG measurements will yield lower postprandial readings~     than FTBG, potentially causing a negative impact on long-term control. It is also possible~     that since ASBG is reportedly more comfortable than FTBG testing, it's use might improve~     adherence to testing and improve long term control.~   "
255448|NCT00207194|"~     The aim of this study is to assess the efficacy of Telephone-Linked_Care for Hypertension~     Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a~     computer-based telecommunication system that will monitor, educate and counsel African~     American adults with hypertension on adherence to medication, diet, and exercise. The primary~     hypotheses are:~        1. TLC-HTN-AA use will improve medication regiment adherence~        2. TLC-HTN-AA will improve adherence to 3 healthy diet recommendations~        3. TLC-HTN-AA will improve levels of regular exercise~        4. Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target~          regiments than patients in the control group~   "
255449|NCT00207181|"~     The purpose of this study is to develop a tool that can more accurately assess the intensity~     and kind of physical activity that a person performs. The experimental tool, which will use a~     mobile computing device as a way of automatically identifying when a certain activity is~     being performed and at what intensity, will be tested against a self reported paper diary of~     activities performed on a day to day basis. It is hoped that this study will increase~     understanding of the health benefits of certain types of physical activity performed in the~     home.~   "
255450|NCT00207168|"~     To assess compliance of once daily dosing to assess their benefits in terms of potency and~     safety as well as their impact on adherence and quality of life.~   "
255451|NCT00207155|"~     The purpose of this study is to predict response to Erbitux as a single agent in patients~     with metastatic colon cancer~   "
255452|NCT00207142|"~     The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load~     < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an~     initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART~     regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous~     NRTI backbone.~   "
255453|NCT00207129|"~     The purpose of this study is to test how BMS-247550 (ixabepilone) affects the removal of~     capecitabine from the body and how capecitabine affects the removal of BMS-247550 from the~     body.~   "
255454|NCT00207116|"~     The purpose of this study is to predict responses to Erbitux as a single agent in patients~     with Non Small Cell Lung Cancer~   "
255455|NCT00207103|"~     This is a Phase I dose escalation study to determine the safety, pharmacokinetics and~     pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.~   "
255456|NCT00207090|"~     The purpose of this study is to test how rifampin affects the removal of BMS-247550~     (ixabepilone) from the body.~   "
255457|NCT00207077|"~     The purpose of this study is to find a safe and effective dose of the combination of~     cetuximab (Erbitux) and Tarceva (erlotinib).~   "
255458|NCT00207064|"~     We want to relate disturbances in first-episode schizophrenic patients in serotonin 5-HT2A~     receptors, brain structure, brain function, and information processing to each other and to~     psychopathology. Additionally, we want to examine the influence of 5-HT2A receptor blockade~     on these disturbances. We expect disturbances in the serotonergic system at baseline to~     correlate with specific structural and functional changes and with disruption in information~     processing as measured with psychophysiological and neurocognitive methods - and we expect~     5-HT2A receptor blockade to reverse some of the functional and cognitive impairments. We do~     not expect any effect of treatment on brain structure~   "
255459|NCT00207051|"~     This is a phase I dose escalation study to determine the safety, pharmacokinetics and~     pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with~     advanced colorectal cancer who have received no more than 2 prior regimens for metastatic~     colorectal cancer.~   "
255460|NCT00207038|"~     Studies have shown that the prevalence of respiratory symptoms, airway hyperresponsiveness~     (AHR) and asthma is high and increasing in elite athletes. The inflammation seen in the~     airways of elite athletes might differ from the inflammation seen in the airways of~     ordinary asthmatics and it might represent a different kind of asthma.~      The primary purposes are~        1. To investigate the type of airway inflammation in young swimmers.~        2. To investigate the acute changes in airway inflammation after a short training session.~   "
255461|NCT00207025|"~     The purpose of this clinical research study is to learn about the safety and tolerability of~     daily BMS-275183 in patients with advanced cancer.~   "
255462|NCT00207012|"~     This is a continuous dosing Phase I Study of BMS-599626 in patients with HER2-expressing~     advanced solid malignancies.~   "
255463|NCT00206999|"~     We wanted to compare the relation of two different psychophysiological paradigms (PrePulse~     Inhibition of the startle response = PPI and P50 suppression) to each other. Additionally, we~     wanted to test the effect of the combined serotonin- and noradrenaline re-uptake inhibitor,~     imipramine, on these measures. The primary hypothesis was that PPI and P50 gating would not~     correlate with each other at baseline. The secondary hypothesis was that increased~     noradrenergic and serotonergic activity would disrupt PPI as well as P50 gating.~   "
255464|NCT00206986|"~     The investigators want to try to improve information processing in schizophrenic patients via~     pharmacological intervention. The hypothesis is that decreased noradrenergic activity will~     normalize information processing (PPI, P50 gating, P300, and mismatch negativity) in patients~     with schizophrenia.~   "
255465|NCT00206973|"~     Study on the relationship between the response of the airways to a bronchial provocation test~     with mannitol and the degree of airway inflammation in asthma patients.~   "
255486|NCT00206687|"~     The purpose of the study is to explore the safety, tolerability and efficacy of Spheramine~     (cultured human retinal pigment epithelial cells on microcarriers) in Parkinson's Disease~     patients with advanced disease who have insufficient symptom control by optimum oral~     medication. Patients are randomized to receive Spheramine injections into both hemispheres or~     a sham surgical procedure in a ratio of 1:1. A three month pretreatment period must be~     completed prior to surgery. Time to endpoint is 24 months.~   "
255466|NCT00206960|"~     We wanted to compare dopamine D2 receptor activity, brain structure, brain function, sensory~     gating and cognition in neuroleptic-naive schizophrenic patients and matched healthy~     controls. Additionally, we wanted to examine the effects of 3 months of treatment with either~     low doses of a typical or an atypical antipsychotic compound on the same functions. The~     hypotheses were that schizophrenic patients suffered from disturbances in brain function and~     structure, information processing, and extrastriatal D2 receptor activity, and that these~     disturbances would be related to each other and to psychopathology. Additionally, we expected~     the atypical compound to have an effect on some of the disturbances in information~     processing, and that the atypical compound - in contrast to the typical drug - would show~     extrastriatal over striatal selectivity.~   "
255467|NCT00206947|"~     The present study will specify and delineate the separate components of cognitive deficits~     and examine the effects of adjunctive cholinergic augmentation on these cognitive deficits as~     well as psychopathology in schizophrenic patients treated with an antipsychotic compound with~     no aberrant binding affinity for the cholinergic receptor system. The hypothesis is that~     cholinergic augmentation using donepezil will improve cognitive deficits, sensory gating~     deficits, and psychopathology in schizophrenic patients treated with an atypical~     antipsychotic (ziprasidone).~   "
255468|NCT00206934|"~     It is of great clinical relevance to know if selective serotonin re-uptake inhibitors affect~     information processing. Our hypothesis was that aspects of information processing would be~     disturbed whereas others would improve.~   "
255469|NCT00206921|"~     The purpose of the study is to compare efficacy and adverse effects of pulsed dye laser and~     intense pulsed light in patients with skin telangiectasia and redness.~   "
255470|NCT00206908|"~     This project is designed to evaluate the clinical utility of a novel blood test, the Triage~     Stroke Panel, as an aid in the diagnosis and assessment of stroke. The Triage Stroke Panel~     test device, used with the Triage MeterPlus, is a rapid, point-of-care immunoassay. The test~     measures the concentration of various analytes present in EDTA-anticoagulated whole blood or~     plasma, specifically B-type natriuretic peptide (BNP), fibrin degradation products containing~     D-Dimer, matrix metalloproteiase-9 (MMP-9), and S-100B. The test utilizes a proprietary~     algorithm for the automatic calculation of a single Multimarker Index (MMX) result from the~     individual biomarker values. The MMX result is being evaluated for use as an aid in the~     assessment and diagnosis of stroke.~   "
255471|NCT00206895|"~     The purpose of the study is to evaluated the efficacy and tolerability of methyl~     aminolevulinate and 5-aminolevulinic acid photodynamic therapy in patients with moderate to~     severe facial acne vulgaris in a randomized controlled and investigator blinded trial.~   "
255472|NCT00206882|"~     The purpose of the study is to evaluate the sun protection effect and efficacy in treatment~     of sunburn using topical corticosteroids in a randomised controlled and investigator blinded~     trial.~   "
255473|NCT00206869|"~     The purpose of the study is to evaluate the effect of exercise and heat on the light~     sensibility of patients with erythropoietic protoporphyria~   "
255474|NCT00206856|"~     To determine the clinical utility of using the Triage® BNP Test to guide therapy in~     outpatients with heart failure~   "
255475|NCT00206843|"~     The purpose of this study is to test whether physicians can make more informed treatment,~     admission, and discharge decisions related to patient care by having serial Triage® BNP test~     results available to assess disease severity, while patients are being treated for HF in the~     Emergency Department and/or during their admission. This is believed to lead to a better~     outcome as well as more efficient and cost-effective treatment.~   "
255476|NCT00206830|"~     SHORTIE is a two-phase study to determine the impact of the Triage Profiler S.O.B. (Shortness~     Of Breath) Panel on patient management, outcome, and cost.~   "
255477|NCT00206817|"~     This clinical trial is being conducted to 1) evaluate the possible usefulness of a panel of~     cardiac markers in assessing emergency department patients with possible acute coronary~     syndrome, 2) evaluate the usefulness of BNP in assessing emergency department patients with~     possible acute coronary syndrome, 3) determine if BNP can be used to predict adverse events~     during hospitalization and in the emergency department, and 4) evaluate how a Point-of-Care~     testing platform affects resource utilization in the emergency department.~   "
255478|NCT00206791|"~     The purpose of this non-comparative study is to test, for the first time, the bioactivity of~     a new “ready to use” calcium phosphate biomaterial in fillings of little losses of osseous~     substance from various origins, such as traumatic and benign tumoral causes.~   "
255479|NCT00206778|"~     We are comparing the efficacy of Lamotrigine to that of Standard of Care Sodium Valproate for~     the treatment of Mixed Mania. The study hypothesis is that Lamotrigine will be more~     efficative for treating mixed mania in patients with Bipolar Disorder.~   "
255480|NCT00206765|"~     We are comparing the efficacy of Risperidone versus Paroxetine in the treatment of panic~     symptoms. The study hypothesis is that Risperidone will be a superior medicine for treating~     panic.~   "
255481|NCT00206752|"~     The purpose of this study is to assess the feasibility of avoiding opposite side neck~     radiation therapy in patients with clearly one side squamous cell cancer of the head and~     neck. We aim to assess the reduction in treatment volume (amount of radiation therapy~     required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck~     radiation therapy.~   "
255482|NCT00206739|"~     The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment~     in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks,~     episodes of anemia, and the overall morbidity and mortality~   "
255483|NCT00206726|"~     This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of~     alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL)~     patients who have received at least one prior therapy.~      Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during~     Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of~     each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and~     at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission~     (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients~     demonstrating presumptive signs of a Complete Remission (CR) will receive no further~     treatment but will be followed for response.~   "
255492|NCT00206609|"~     The purpose of this study is to determine the effect that oxygen has when administered to~     patients complaining of shortness of breath, where the underlying cause of this symptom is~     advanced cancer. The study tests the hypothesis that oxygen improves shortness of breath more~     than air in this population. Both oxygen and air will be administered to patients in random~     order and in a blinded fashion, with patients asked to rate their shortness of breath before~     and after each gas. Finally patients will be asked which gas they prefer.~   "
255493|NCT00206596|"~     The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need~     for steroid treatment for Crohn's disease.~   "
255494|NCT00206583|"~     The purpose of this study is to determine whether the study drug is safe and effective in the~     prevention of pregnancies in a large group of volunteers.~   "
255495|NCT00206570|"~     To investigate the 'estrogen-protection' hypothesis by comparing changes in psychotic~     symptoms between one group of patients receiving standard antipsychotic drug treatment plus~     placebo and a second matched group receiving standard antipsychotic drug treatment plus~     100microgram estradiol patch in a double blind controlled trial.~      Hypothesis : That the women receiving adjunctive estradiol will demonstrate a more rapid and~     more substantial decrease in psychotic symptoms over the course of the study than the women~     receiving adjunctive placebo.~   "
255496|NCT00206557|"~     The aim of the project is to investigate the use of raloxifene (a new form of estrogen) as a~     treatment for schizophrenia in postmenopausal women. Raloxifene is a selective estrogen~     receptor modulator (SERM) which means that it can affect the central nervous system effects~     of estrogen (eg: improving emotional symptoms, memory, information processing and~     concentration), without adversely affecting reproductive tissue / organs such as breast,~     uterus and ovaries.We are conducting a double blind placebo controlled 3 month duration study~     comparing the psychotic symptom response between three groups of postmenopausal women with~     schizophrenia. One group will receive standard antipsychotic medication plus 60mg Raloxifene,~     the second group receives standard antipsychotic medication plus Hormone Therapy(estradiol~     2mg oral per day + dyhydroprogesterone 10mg oral per day) and the third group receives~     standard antipsychotic medication plus oral placebo. Hypothesis 1: That the women receiving~     adjunctive raloxifene or HT would have a quicker recovery from psychotic symptoms, as~     measured on the rating scales, compared with the women receiving adjunctive~     placebo.Hypothesis 2: That the Raloxifene group would have better cognitive improvement than~     the other two groups.~   "
255497|NCT00206544|"~     OBJECTIVE:~      To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind,~     placebo-controlled study in the treatment of acute mania/hypomania.~      HYPOTHESIS:~      That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and~     more substantial decrease in manic symptoms over the course of the study than women receiving~     adjunctive placebo.~      STUDY POPULATION:~      Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective~     disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and~     Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association.~      STUDY MEDICATION:~      Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen~     at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to~     maintain blinding of treatment arm.~      Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral~     Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain~     capsule identical to that used with Tamoxifen.~      Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo~     (inert substance). The placebo substance will be administered within a plain capsule~     identical to that used with Tamoxifen and Progesterone.~      STUDY EVALUATIONS:~      Data will be collected over a 28-day period for each patient. Visits will be performed at~     baseline, and then at weekly intervals. A total of five visits will be completed for each~     patient. The following evaluations will be performed:~        -  Psychiatric evaluation to determine diagnosis. (Baseline visit only)~        -  General clinical evaluation including medical history, current conditions and a~          non-invasive physical examination, body weight, vital signs. (Baseline visit only)~        -  Medication history (baseline and evaluation visits).~        -  Demographics (baseline visits only).~        -  Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale~          (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle~          Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint~          (day 28) visit.~        -  Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH),~          follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin,~          dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and~          evaluation visits).~        -  Inclusion/exclusion checklist (baseline visit only).~        -  Informed consent (baseline visit only).~   "
255498|NCT00206531|"~     While HIV mainly infects mature T-cells it can also infect newly produced (or naïve) T-cells.~     These infected naïve T cells may then act a viral reservoir even in patients with~     undetectable viral loads. Understanding when and how these cells are infected is important~     because it could help us to understand why patients fail therapy even if they have a~     persistently undetectable viral load.~   "
255499|NCT00206518|"~     The purpose of this study is to learn if the biomarker information obtained (learned or~     received) from the earlier studies can tell us whether or not Taxotere and/or~     Adriamycin/Cytoxan can cause tumors to become smaller.~   "
255500|NCT00206505|"~     The purposes of this study are to better understand how Taxotere causes tumors to become~     smaller and to find out how effective Taxotere is in treating the type of breast cancer that~     you have.~   "
255501|NCT00206492|"~     The researchers want to learn whether ZD1839 can improve the activity of tamoxifen, a drug~     that participants will receive for the treatment of the type of breast cancer being studied.~     Tamoxifen medicine is part of the standard treatment for the type of breast cancer being~     studied. It is approved for the treatment of this problem. In order to help the researchers~     understand how the cancer responds to these medicines, the researchers will take a small~     tissue sample (biopsy) of the breast cancer before beginning treatment and after two weeks of~     treatment, at 6 weeks and when surgery is done as part of treatment for the cancer. If~     participants do not respond to treatment, another biopsy will be done to see why the~     participants did not respond. These samples will also be collected to look at different~     characteristics of the cancer. The researchers cannot and do not guarantee that participants~     will benefit if they take part in this study~   "
255502|NCT00206466|"~     We are asking you to take part in a research study of biomarkers (characteristics or traits~     of the genes inside cancer cells). We want to learn if these biomarkers could help us learn~     how well your breast cancer may respond (improve) to chemotherapy (drugs to treat cancer).~   "
255517|NCT00206271|"~     Background: Long-lasting pain and disability, known as chronic whiplash-associated disorder~     (WAD), may develop after forced flexion-extension trauma to the cervical spine. Mechanisms~     behind WAD are virtually unknown, as are the possible effects of early intervention. This~     trial was undertaken to compare the effect of three early intervention strategies for the~     prevention of developing chronic WAD following acute whiplash injury.~      Methods: 458 participants were randomised to one of 1) stiff neck collar, 2) advice to~     act-as-usual, or 3) an active mobilisation regime. Participants were followed for one year~     and treatment effects were compared in terms of lasting neck pain, headache, disability and~     sick-leave.~   "
255503|NCT00206453|"~     We, the investigators at Baylor Breast Care Cancer, are doing this study to learn how well~     Taxotere makes tumors become smaller. We are also doing this study to find out how well~     Taxotere treats the type of breast cancer that some patients have. We are asking patients to~     take part in this study because they have locally advanced breast cancer. Women with this~     breast cancer will usually receive chemotherapy medicines to reduce or shrink the cancer~     before surgery to take out the cancer. If patients choose to take part in this study, they~     will receive Taxotere and the combination of cyclophosphamide and doxorubicin. These~     medicines are part of the standard good medical care for this type of breast cancer. They are~     approved for the treatment of this problem. To help us learn how the patients' cancer~     responds to these medicines, we will take a small tissue sample (biopsy) of the patients'~     breast cancer before beginning treatment, one day after the first dose of treatment, once~     each week for the first three weeks of treatment, and when surgery is done as part of~     treatment for their cancer. These samples will be collected also to look at the biology of~     the patients' cancer. We will also use a new method called cDNA array technology, which lets~     us look at thousands of genes (coding information inside the cancer cell) at once. By looking~     at different genes in the breast cancer, we may learn important information about which~     cancers will respond to a chemotherapy medicine. We hope to learn if there are different gene~     patterns in patients whose tumors shrink or do not shrink with this chemotherapy medicine.~     This information may help us, in the future, to choose the right medicines for women with~     breast cancer so that they have the highest chance of their cancer shrinking with~     chemotherapy medicine. We cannot and do not know if patients will benefit if they take part~     in this study.~   "
255504|NCT00206440|"~     This study will look at a drug called esomeprazole, the newest PPI, as a way to further~     reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin~     or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach~     acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they~     may be able to enjoy their daily routines much more while they are getting chemotherapy.~   "
255505|NCT00206427|"~     We want to learn whether GW572016 is effective in breast cancers that have HER2.~   "
255506|NCT00206414|"~     The investigators want to know if combining Arimidex and Faslodex with Iressa will be an~     effective treatment for breast cancer. They also want to know, using special tests on the~     tumor, the changes that occur with the treatment so they can try to improve their treatment~     for breast cancer in the future.~   "
255507|NCT00206401|"~     In this study, we plan to examine the difference in effect on blood glucose control in~     patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice~     daily, injected separately) or on intensive insulin management (IIM-several shots of short~     acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the~     short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be~     used to monitor blood glucose control over a 6 month period. Twice during the course of the~     study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records~     blood sugar readings every 5 minutes) will be used to record all the changes in the blood~     glucose levels occurring over a 72-hour period.~   "
255508|NCT00206388|"~     The purposes of this study are:~        1. To find the highest dose of monthly intravenous Zometa that can be given with daily low~          doses of cyclophosphamide by mouth to children with recurrent or refractory~          neuroblastoma without causing severe side effects.~        2. To find out the side effects seen by giving Zometa and cyclophosphamide on this schedule~          at different dose levels.~        3. To measure blood and urine levels of Zometa during treatment~        4. To preliminarily evaluate the antitumor activity of Zometa and concomitant oral~          cyclophosphamide in children with recurrent and/or refractory neuroblastoma within the~          confines of a Phase I study.~        5. To measure the effects of Zometa on markers of bone breakdown found in urine, blood, and~          bone marrow~        6. To measure the effects of Zometa on the immune system.~   "
255509|NCT00206375|"~     The purpose of this study is to see if giving growth hormone and Lupron along with thyroid~     hormone will improve final height in patients with long term hypothyroidism. Lupron is a~     medicine which is used to delay puberty and to prevent early closure of growing bones which~     might increase growth potential. Growth hormone is used to restore growth rate. This study~     will include children with short term and long term hypothyroidism.~   "
255510|NCT00206362|"~     The purpose of this study is to learn about the relationship that exists between coping~     skills and blood glucose control. In addition to this, we will study the effect of type 1~     diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic~     groups, and the duration of diabetes.~   "
255511|NCT00206349|"~     The purpose of this study is to learn about the relationship that exists between coping~     skills and blood glucose control. In addition to this, we will study the effect of Type 1~     diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic~     groups, and the duration of diabetes.~   "
255512|NCT00206336|"~     Previous studies using topiramate in Tourette subjects have shown that with the use of this~     medication subjects report that their tics get better. The purpose of this study is to study~     if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other~     associated symptoms such as attention or obsessive-compulsive problems.~   "
255513|NCT00206323|"~     Previous studies using topiramate in Tourette subjects have shown that with the use of this~     medication subjects report that their tics get better. The purpose of this study is to study~     if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other~     associated symptoms such as attention or obsessive-compulsive problems.~   "
255514|NCT00206310|"~     The purpose of the study is to investigate if rosuvastatin, added on top of all other~     medicines prescribed to subjects with symptomatic systolic heart failure, reduces the~     combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal~     stroke (time to first event)~   "
255515|NCT00206297|"~     The purpose of this study is to see if reducing the dose of insulin before a meal and giving~     both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars~     after a meal. In addition, the study will look at giving pramlintide as a basal infusion (a~     very low steady dose) for several hours~   "
255516|NCT00206284|"~     The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and~     75 mg). The secondary objectives are to compare the efficacy between the three doses of~     AZD0865 and esomeprazole 20 mg and to evaluate the safety and tolerability of AZD0865.~   "
255518|NCT00206258|"~     The purpose of this study is to see if giving pramlintide and insulin before a meal would~     lower high blood sugar and if a glucagon (a naturally made hormone in the body but reduced in~     diabetes and its role is in prevention of low blood sugar) shot given in the late after~     meal time would prevent low blood sugar. The studies outlined in this proposal might help in~     developing new treatment options to target after meal high blood sugar and before meal low~     blood sugar in children. This would possibly help improve overall blood sugar control and~     prevent the long-term complications of diabetes.~   "
255522|NCT00206206|"~     In response to the evidence supporting “tight” glucose control (70 – 110) in the critical~     care setting, the MMH ICU developed a protocol utilizing regular intravenous insulin. This~     protocol was initiated in 2002. Monitoring of the data collected revealed effective glycemic~     control when this protocol was used. However, limited utilization has led to overall~     ineffective glycemic control in this ICU. The poor utilization is largely due to a general~     reluctance of physicians to start their patients on an intravenous insulin infusion. As~     contributing to this poor compliance is the “open” nature of the ICU. The MMH ICU is an~     “open” ICU, meaning that many physicians across multiple subspecialties admit to this unit.~     Approaches to controlling hyperglycemia vary greatly, depending largely upon the treating~     physician. In an attempt to improve overall glycemic control in this “open” ICU, the~     Subcutaneaous Insulin Aspart Hyperglycemia Protocol (SIAP) was developed which incorporates a~     subcutaneous insulin aspart regimen that triggers the use of a regular insulin infusion~     protocol when the SIAP is not adequately controlling the patient’s blood glucose.~      This study aims to evaluate 1) the effect the SIAP on overall glycemic control in the ICU, 2)~     the effectiveness that the SIAP has on controlling blood glucose as compared with past~     practices using regular insulin, and 3) the effect the SIAP has on patient complications and~     outcomes in the MMH ICU.~   "
255523|NCT00206193|"~     The purpose of this study is to determine which medical treatment is the most effective to~     terminate a pregnancy.~   "
255524|NCT00206180|"~     The purpose of this study is to decide if controlling stomach acid is related to healing of~     erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg~     once daily.~   "
255525|NCT00206167|"~     The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler~     (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with~     chronic obstructive pulmonary disease (COPD).~   "
255526|NCT00206154|"~     The purpose of this study is to compare a combination asthma drug (Symbicort) with its two~     components, budesonide and formoterol, taken individually or in combination, and with placebo~     in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease~     (COPD)~   "
255527|NCT00206141|"~     This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in~     treating bipolar depression during an 8-week acute phase compared with placebo and lithium,~     followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel)~     compared to placebo.~   "
255528|NCT00206128|"~     The purpose of this study is to determine that the efficacy of the sustained release (SR)~     formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR)~     formulation.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
255529|NCT00206115|"~     The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained~     Release (SR) is more effective than placebo in the treatment of acute schizophrenia.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
255530|NCT00206102|"~     This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic~     potential of quetiapine fumarate (SEROQUEL) compared with that of a putative~     non-cataractogenic antipsychotic medication risperidone (RISPERDAL). This study is being~     conducted to fulfill the SEROQUEL Phase IV commitment regarding evaluation of cataractogenic~     potential.~   "
255531|NCT00206089|"~     This study is being carried out to study the efficacy and safety of treatment with melagatran~     injection followed by ximelagatran tablets in preventing blood clots, compared with~     enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be~     done approximately 6 months after the surgery.~   "
255532|NCT00206076|"~     The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone,~     or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after~     liver transplantation, in an attempt to reduce the potential side effects from using~     cyclosporine or tacrolimus.~   "
255533|NCT00206063|"~     The purpose of this study is to evaluate tolerability of long-term treatment with~     ximelagatran compared to standard treatment with warfarin.~   "
255534|NCT00206050|"~     This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole~     (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed~     Release Tablets ), in subjects who continue to require acid-suppressive therapy following a~     course of intravenous (iv) pantoprazole (PROTONIX ® I.V. for Injection).~   "
255535|NCT00206037|"~     The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with~     TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in~     time, compared to patients receiving TomoFix without COLLOSS E.~   "
255536|NCT00206024|"~     This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to~     investigate the relationship between dose of esomeprazole magnesium and acid-associated~     heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole~     magnesium in doses up to 40 mg BID will also be assessed.~   "
255537|NCT00206011|"~     This study is a comparison of open surgery versus an endoscopic approach in condylar neck~     fractures; it will look at functional outcome, cosmetic outcome and patient satisfaction.~   "
255538|NCT00205998|"~     Primary objective of the study is to demonstrate specific indications for the~      surgical treatment of distal radius fractures using the locking compression~      plate.~   "
255539|NCT00205985|"~     The aim of this study is to compare the time to return to previous activity~      level between operative treatment and non-operative cast immobilization of~      patients with an acute complete fracture of the middle part of the scaphoid,~      without any dislocation or comminution visible CT-scan.~   "
255540|NCT00205972|"~     The aim of the study is to radiologically compare the fracture healing as well~      as the functional treatment outcome of conservative and operative treatment of~      defined humerusshaft fractures after 6w./12w./and 12 month based on the~      modified constant score.~   "
255541|NCT00205959|"~     The aim of the study is to compare the results regarding fracture healing~      and functional outcome after the treatment of proximal humeral fractures~      with the four different treatment methods after 12w./6months and 12 months~      based on radiological evaluation as well as the constant score and the~      neer score.~   "
255546|NCT00205894|"~     The purpose of this study is to evaluate the safety and efficacy of a implantable device,~     called the bion(R), in the treatment of chronic headache. The bion microstimulator is placed~     underneath the skin next to the greater occipital nerve. The bion microstimulator then~     stimulates the nerve by generating small amounts of electrical current.~   "
255547|NCT00205881|"~     Normal hearing listeners gain important everyday benefits from listening with two ears~     (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of~     bilateral hearing include the ability to determine where sounds are coming from and the~     ability to hear sounds and understand speech in noisy environments. Based upon these~     advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants~     (one in each ear) and (2) compare HiResolution sound processing with conventional sound~     processing.~   "
255548|NCT00205868|"~     The purpose of this study is to assess the acute and chronic effectiveness of the Advanced~     Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery~     syndrome and associated low back axial pain.~      Subjects will undergo a temporary or permanent trial to assess their candidacy for placement~     of an implantable pulse generator. Those who demonstrate a significant clinical reduction in~     pain will be enrolled in the chronic study. Subjects will be followed for 12 months post~     implantation to assess the long-term effectiveness of the therapy.~   "
255549|NCT00205855|"~     There are many treatment options available for the management of chronic pain . Some include,~     but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs,~     Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks.~     Historically, the mainstay of pain treatment has been pharmacotherapy. However,~     pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable~     side effects. Although many patients are successfully treated, for those who fail some of~     these more conservative therapies the remaining option is limited to spinal cord stimulation~     (SCS), proven to be an effective therapy to more than half of those failing conservative~     treatments . Over 50% of those who have failed these more conservative methods of pain~     management, can now, under the guidance of a clinician utilizing SCS, have their pain levels~     successfully managed. SCS is a less invasive therapy that is a reversible treatment with~     greater long-term benefits than more permanent, radical approaches and one that deserves~     greater consideration in the management of chronic, intractable pain.~   "
255550|NCT00205842|"~     Patients undergoing major abdominal surgery are at highest risk for developing Postoperative~     Ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal~     distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable~     reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and~     inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given~     30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function~     in patients having partial small or large bowel resections.~   "
255551|NCT00205829|"~     This is a prospective, single-centre, cross-over study designed to evaluate the safety and~     efficacy of using the bion, an implantable medical device, for the treatment of chronic~     headaches. The clinical study is proposed to determine the anticipated adverse event rate and~     treatment outcomes at the conclusion of the study. Each trial subject will serve as his/her~     own control.~   "
255552|NCT00205816|"~     The purpose of this study is to provide a mechanism for the emergency use of tigecycline in~     the appropriate clinical situations.~      The secondary objective is to evaluate the safety and efficacy of tigecycline in the~     treatment of patients with selected serious infections where other treatment has not been~     successful.~   "
255553|NCT00205803|"~     The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent~     pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this~     vaccine in infants.~   "
255554|NCT00205790|"~     To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and~     Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a~     claim of substantial equivalence.~   "
255555|NCT00205777|"~     The purpose of this study is to determine whether bazedoxifene acetate is safe and effective~     in the treatment of osteoporosis in postmenopausal women.~   "
255556|NCT00205764|"~     This is an international,multicenter, prospective, open, double randomised and controlled~     phase III study to compare the therapeutic efficacy of tandem high dose Melphalan versus~     triple intermediate dose Melpahaln in newly-diagnosed myeloma patients~   "
255557|NCT00205751|"~     This is an international multi-center prospective, double randomized, open, controlled phase~     III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide~     plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma~     patients.~   "
255558|NCT00205738|"~     Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in~     individuals with schizophrenia than in healthy subjects or in other psychiatric conditions.~     Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation.~     Hyperglycemia can contribute to long-term cardiovascular disease risk that may already be~     increased in patients with schizophrenia due to higher rates of smoking, sedentary life~     style, obesity and under-treated hypertension and dyslipidemia. This project will~     characterize the effects on glucose control of the two most commonly prescribed newer~     antipsychotic medications, risperidone and olanzapine, in patients with schizophrenia.~      This proposal specifically hypothesizes that olanzapine treatment will be associated with~     decreases in insulin sensitivity (SI), without effects on insulin secretion.~     Treatment-related effects on glucose effectiveness (SG) will be explored.~   "
255559|NCT00205725|"~     Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in~     individuals with schizophrenia than in healthy subjects or in other psychiatric conditions.~     Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation.~     Hyperglycemia can contribute to long-term cardiovascular disease risk that may already be~     increased in patients with schizophrenia due to higher rates of smoking, sedentary life~     style, obesity and under-treated hypertension and dyslipidemia. This project will~     characterize the effects on glucose control of the two most commonly prescribed newer~     antipsychotic medications, ziprasidone and olanzapine, in patients with schizophrenia.~   "
255560|NCT00205712|"~     Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for~     emergency sedation in children because it causes deep sedation with minimal respiratory~     depression in comparison to other available agents. However, emergence reactions are an~     important adverse effect of ketamine, characterized by transient changes in cognitive~     function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral~     effects are dose-dependently induced by ketamine and other antagonists of the~     N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit~     excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has~     been proposed to explain key features of schizophrenia. Several treatments that block~     excessive excitatory transmitter release have also been shown to prevent cognitive and~     behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2~     adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent~     mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However,~     this prevention strategy has not been evaluated in children. Children currently receive~     clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an~     important target for pharmacological strategies aimed at the prevention of schizophrenia.~     This application proposes a double-blind, placebo-controlled, randomized trial to test the~     safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in~     preventing ketamine-induced mental symptoms in children. Planned primary analyses will~     evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables~     using analysis of variance (ANOVA). The proposed experiments are relevant to future~     prevention trials for individuals at risk for schizophrenia, and to preventing adverse~     effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).~   "
255561|NCT00205699|"~     The prevalence of overweight and obesity, insulin resistance, hyperglycemia, dyslipidemia and~     type 2 diabetes mellitus (T2DM) are increasing in children. Increased adiposity and related~     reductions in insulin sensitivity are major risk factors for the development of~     hyperglycemia, dyslipidemia, T2DM, and cardiovascular disease. Reductions in lifespan~     attributable to obesity impact younger individuals most measurably. Antipsychotic medications~     are extensively used in children, with certain agents producing greater increases in weight~     and adiposity than other commonly used drugs in this age group. Increased use of atypical~     antipsychotics in children has been stimulated by reported efficacy for behaviors such as~     aggression that can occur in a variety of disorders. However, no previous randomized clinical~     trial has sensitively quantified the metabolic effects of widely used atypical~     antipsychotics. This study would address clinically relevant questions concerning both the~     safety and efficacy of these agents in antipsychotic-naïve aggressive children with conduct~     disorder, with permitted co-morbidity for a variety of psychiatric conditions including~     attention deficit disorder, bipolar disorder, high functioning pervasive developmental~     disorder, autism and schizophrenia. The project aims to describe and compare the outcome of~     12 weeks of prospective, randomized treatment with olanzapine, risperidone or aripiprazole on~     insulin action in skeletal muscle, liver and adipose tissue, insulin secretion, abdominal fat~     mass, total body and fat-free mass, resting metabolic rates, efficacy for symptoms of~     aggression and non-metabolic adverse events. Children aged 6-18 will be studied, exploring~     effects of stimulant therapy and age-related differences in vulnerability to~     treatment-induced adverse metabolic changes. Aims are addressed by measuring glucose and~     lipid kinetics with stable isotope tracers, area-under-the-curve for post-load insulin and~     c-peptide during frequently sampled oral glucose tolerance tests, body composition with dual~     energy x-ray absorptiometry and magnetic resonance imaging (MRI), indirect calorimetry and~     standardized assessments of efficacy and adverse events. Treatment effects will primarily be~     analyzed using repeated measures analysis of covariance (ANCOVA), controlling for baseline~     adiposity and other key risk variables. Relevant data are critically needed to target~     clinical therapy and basic research, identify medical risks, and guide regulatory decisions~     in this vulnerable population.~   "
255562|NCT00205686|"~     DHEA or dehydroepiandrosterone is a naturally occurring hormone secreted by tghe adrenal~     galnds. The secretion of HDEA declines with aging. DHEA is considered a food supplement and~     it is not regulated by the FDA. The purpose of this research is to evaluate ceratin of the~     biological effects of a reaplcement dose of DHEA. As you get older, DHEA levels are lower~     than you were younger. The replamcent dose is the dose of DHEA that will raise DHEA levesl to~     the levels found in young people. Anotehr purpose is to determine whether DHEA enhances the~     adaptations to an exercise training program.~   "
255563|NCT00205660|"~     This proposal aims to use well-validated methodologies such as dual energy x-ray~     absorptiometry (DEXA), frequently sampled oral glucose tolerance tests (fsOGTTs), and~     hyperinsulinemic euglycemic clamps to characterize the metabolic effects of 12 weeks of~     aripiprazole treatment following chronic pretreatment with olanzapine, quetiapine,~     risperidone or ziprasidone.~      We hypothesize that switching to aripiprazole treatment will induce improvements in total~     body adiposity, inflammation (e.g., high sensitivity C-reactive protein [hsCRP]), glucose~     metabolism (e.g., insulin sensitivity) and lipid metabolism (e.g., fasting plasma~     triglyceride), in comparison to chronic pretreatment with olanzapine, risperidone and~     quetiapine.~   "
255564|NCT00205647|"~     This is a randonmized, masked, placebo-controlled parallel group, clinical trial to evaluate~     the effects of three different doses of N-acetyl L-cysteine (NAC) and placebo on patient~     safety and on physical and transport properties of expectorated sputum. Patient sumptoms,~     quality of life and exacerbation will also be followed as well as pulmonary function testing~     and functional exercise capacity. We hypothesized that a prolongeed course of oral NAC~     favorably affects the morbidity of chronic bronchitis, particularly the incidence of acute~     exacerbations.~   "
255565|NCT00205634|"~     The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum~     abnormalities, lung function, and overall feeling of well-being in people with cystic~     fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory~     infections in people who do not have CF, and is sometimes used in CF patients as well.~     Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some~     preliminary studies that have been done in CF patients suggest that Biaxin might have a~     beneficial effect on CF sputum in ways unrelated to its antibiotic activity.~   "
255566|NCT00205621|"~     In this study in-vivo quantification of amyloid load will be performed in patients with AD,~     MCI and normal controls with Positron Emission Tomography. For this the PET tracers [11C]PIB~     and [18F]FDDNP will be compared.~   "
255567|NCT00205608|"~     Patients with schizophrenia have volume loss in gray matter. This study is designed to~     evaluate whether their is microglia activation in schizophrenia using [11C](R)-PK11195 PET.~   "
255568|NCT00205595|"~     This is a study using Positron Emission Tomography (PET) to study the normal distribution of~     the PET ligand (R)-[11C]PK11195. This ligand will be used to study inflammation in the brain~     in several brain disorders like Alzheimer's disease and traumatic brain injury.~   "
255569|NCT00205582|"~     Excitatory amino acids may be involved in secondary neuronal damage after traumatic brain~     injury. The amount of microglia activation is an indirect measure of neuronal damage.~     Micorglia activation will be measured R)-[11C]PK11195 PET 1 week, 1 month and 6 months after~     brain injury.~   "
255570|NCT00205569|"~     To learn more about behavior and everyday functioning after brain injury, and to learn if~     behavior and functioning gets better with more education about changes after brain injury.~   "
255571|NCT00205556|"~     The purpose of this study is to compare the effect of low flux hemodialysis with online~     hemodiafiltration on all cause mortality and a combination of cardiovascular morbidity and~     mortality in chronic hemodialysis patients.~   "
255573|NCT00205530|"~     To learn more about how a family treatment program helps people after brain injury.~     Specifically, do families feel better and function better after going through the program,~     and do patients feel better and function better after going through the program.~   "
255574|NCT00205517|"~     Certain methods of sedation increase the duration of respiratory failure. Two strategies, a~     nursing- implemented sedation algorithm and daily interruption of sedatives, decrease length~     of mechanical ventilation compared to conventional care but have not been compared to each~     other. The reason certain methods of sedation lead to prolonged respiratory failure is~     unknown but may be related to altered pharmacokinetics and dynamics that are unique to~     critically ill patients. Critically ill patients receive substantial doses of sedatives over~     prolonged periods. The impact of these management strategies on short- and long-term~     psychiatric complications are unknown. The study seeks to test the central hypothesis that~     sedation practices impact strongly on outcome of respiratory failure and psychiatric~     complications. The three specific aims are (1) to compare two sedation strategies (protocol~     directed sedation and daily interruption of sedatives), (2) to examine the prevalence of~     psychiatric complications, and (3) to compute the pharmacokinetics of commonly used sedatives~     and narcotics.~      These aims will be achieved by enrolling critically ill patients in a prospective randomized~     trial comparing the above mentioned sedation strategies, and assessing sedation level as well~     as delirium throughout the duration of respiratory failure. Sedative plasma levels will be~     measured, and pharmacokinetics computed. Psychiatric morbidity will be assessed by~     administration of validated questionnaires.~   "
255575|NCT00205504|"~     Oral contraceptives (OCs) are the most widely used method of reversible birth control.~     However, the long-term cardiovascular safety of the widely used low-dose OCs~     (ethinyl-estradiol < 50 mcg) is still debated. Although cardiovascular events are rare in~     young women whether they use OCs or not, the risks of myocardial infarction and ischemic~     stroke are increased among users of OCs who have conventional cardiovascular risk factors~     such as use of tobacco, diabetes or hypercholesterolemia. However, the risk of cardiovascular~     events in OC users with emerging cardiovascular risk factors (such as obesity and the~     metabolic syndrome) have not been investigated. Recently, the metabolic syndrome has been~     linked with the risk of cardiovascular disease. The syndrome is a clustering of risk factors~     in a single individual, and its underlying cause may be insulin resistance. Whether the~     metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied.~     This is a critical problem because the metabolic syndrome is prevalent in 24% of adults.~     Until the cardiovascular risks in users of OC are clearly defined, the appropriate use of OC~     with the least harm would not be possible.~      The investigator's long-term goal is to understand the best way to prevent and treat~     cardiovascular disease in women. The objective of this particular project is to obtain pilot~     data on the extent to which the metabolic syndrome and obesity affects glucose metabolism and~     cardiovascular risks in women taking OCs. The researchers hypothesize that women with~     metabolic syndrome and obese women will have worsened glucose metabolism and elevated~     cardiovascular risks associated with OC use, when compared to normal weight women without the~     metabolic syndrome. Results of this study will clarify the risk factors for cardiovascular~     events in women taking OCs, and will serve as pilot data for a National Institutes of Health~     (NIH) proposal. Once the cardiovascular risk factors of OC users are understood, clinicians~     can make better informed decisions about contraceptive choices for their patients.~   "
255576|NCT00205491|"~     The purpose of this study is to determine if treatment with venlafaxine reduces symptoms of~     depression in persons with traumatic brain injury.~   "
255577|NCT00205478|"~     The purpose of this study is to assess the clinical activity and safety of two doses of~     VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.~   "
255578|NCT00205465|"~     To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis~     treated for 28 days.~   "
255579|NCT00205452|"~     The only established treatment for the complete resolution of hyperparathyroidism is the~     surgical removal of the affected glands. While proven as a means of resolving~     hyperparathyroidism, there have been no comprehensive preoperative and postoperative~     assessments to determine quality of life for patients undergoing minimally invasive vs.~     traditional parathyroid surgery. Quality of life will be assessed in subjects undergoing~     minimally invasive procedures and traditional procedures using a clinically validated survey.~     We will gather data one week preoperatively as well as one week and one year postoperatively~     then compare the survey results from the two study groups to each other. We will also compare~     the study groups to a control group consisting of patients undergoing thyroid surgery. Our~     ultimate goal is to clarify if minimally invasive parathyroid surgery techniques contribute~     to a higher patient quality of life as compared to traditional techniques.~   "
255580|NCT00205439|"~     The primary goal of this study is to determine the prevalence of tracheobronchial carcinomas~     in patients with a history of squamous cell cancer of the aerodigestive tract who have been~     treated with a curative intent and remain disease free. Detection of pre-invasive and~     invasive lesions (moderate to severe dysplasia, CIS) with fluorescence bronchoscopic~     surveillance may help to define the natural history of these lesions and allow earlier~     intervention should they progress to invasive lesions.~   "
255581|NCT00205426|"~     This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a~     favorable hemodynamic profile in lung transplant recipients that will allow for the avoidance~     of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide will decrease~     the otherwise historically mandated use of iNO by 50%, as compared to the necessity of iNO~     use by matched historical controls.~   "
255582|NCT00205413|"~     This clinical research protocol proposes to perform low dose helical computed tomographic~     (CT) scanning in 250 high-risk patients (125/year for two years) in order to detect lung~     carcinomas when they are small and subject to effective curative therapies.~   "
255583|NCT00205400|"~     Hypothesis: Does the time spent within the target INR range differ when patients are managed~     by AMD or IT models of anticoagulation care?~      Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving~     chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Consenting~     patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face~     visits every 4 weeks (AMS model) or clinic visits every 3 months with interim laboratory~     visits and telephone follow-up every 4 weeks (IT model). At study conclusion, the amount of~     time the INR is within target range will be compared between the two groups. Thromboembolic~     and bleeding event rates, patient knowledge, quality of life and healthcare utilization will~     also be analyzed.~   "
255584|NCT00205387|"~     Cardiac elastography is a new technique to analyze strain and strain rates in many organ~     systems, including the heart. In this study, cardiac elastography derived from the analysis~     of raw radiofrequency data obtained from a conventional clinical echocardiograph system will~     be compared to processed information that comes from the same echocardiograph system. The~     purpose of this study is to determine if cardiac elastography can accurately determine strain~     and strain rates as compared to more conventional means.~   "
255585|NCT00205374|"~     Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx~     in the pediatric population. The impact of the disease on patients and families can be~     tremendous due to the need for frequent treatment. It would be highly beneficial to develop~     effective medical therapies as adjunctive measures to surgical ablation with the goal of~     reducing the frequency of reoccurrence.~   "
255586|NCT00205361|"~     The purpose of the study is to determine the variability of airway IgA levels in~     anesthetized, well-nourished and malnourished patients undergoing elective general surgical~     procedures and the effect of gender and race on this baseline variable. The hypothesis is~     that airway IgA levels are lower in malnourished than in well-nourished patients.~   "
255587|NCT00205348|"~     To date, there have been no comprehensive studies on swallowing function in patients~     undergoing surgery for multinodular goiter. We hypothesize that 1. Multinodular goiter has~     significant effect on swallowing function in symptomatic and asymptomatic patients, which can~     be demonstrated by a standardized questionnaire and a formal swallowing evaluation and 2.~     Surgery will improve swallowing function as measured post-operatively by these same~     parameters. Patients with multinodular goiter will be asked to fill out a validated survey~     (SWAL-QOL) on swallowing function in addition to undergoing a formal swallowing evaluation~     before and after surgery for multinodular goiter (subtotal thyroidectomy) and compared to~     patients undergoing total thyroidectomy for follicular cancer and less extensive thyroid~     surgery for other benign processes (lobectomy or lobectomy plus isthmusectomy).~   "
255588|NCT00205335|"~     This study is designed to determine if there is an impact on blood glucose control in~     patients who receive free test strips. Patients in the study have no insurance or insurance~     that does not cover the purchase of test strips. A comparison of weight, blood pressure, and~     Hemoglobin A1C from entry to the final visit will be used to compare patients' management of~     their diabetes. Recommended values for these parameters will be used as the standard for~     comparisons. The investigators anticipate that patients receiving free test strips will show~     an improvement in the listed parameters as well as in satisfaction with their care.~   "
255589|NCT00205322|"~     The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain~     and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an~     oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both~     patient convenience and lack of associated catheter-related complications.~   "
255590|NCT00205309|"~     This study will examine the impact of acute illness on sequential airway IgA levels in~     intensive care patients who will require prolonged intubation. Infections are the most common~     cause of late deaths in non-head injured trauma patients and a frequent cause of morbidity~     and mortality in hospitalized patients, especially intubated Intensive Care Unit (ICU)~     patients. Nosocomial pneumonia is the most common of these infections, and its incidence in~     defined populations of critically injured patients is responsive to route and type of~     nutrition. This study will focus on the mechanisms of specific immune mucosal defenses in~     intestinal and extraintestinal sites and link enteral feeding (or lack of it) with~     maintenance (or deterioration) of respiratory mucosal defenses.~   "
255591|NCT00205296|"~     We hypothesize that improvement in cardiovascular fitness is associated with a greater~     improvement in insulin sensitivity than improvement in body composition (loss of body fat) is~     associated with insulin sensitivity. Towards that we are randomizing children who are~     overweight, or children with low fitness levels to exercise intervention 2 or three times per~     week.~   "
255592|NCT00205283|"~     The purpose of this study is to assess the impact of prospective drug level monitoring and~     dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of~     HIV-infected patients who have achieved virologic success while receiving a nelfinavir~     containing highly active antiretroviral therapy (HAART) regimen.~   "
255593|NCT00205270|"~     Research Question: How do antibody and T cell responses following influenza vaccine compare~     among lung transplant patients, patients waiting for lung transplantation and healthy~     individuals?~      Experimental Design: This interventional parallel group study will compare influenza vaccine~     induced immune responses in three groups: lung transplant patients, individuals waiting for~     lung transplantation and healthy individuals.~      Current and Future Research Activities: Blood will be drawn for these measures of vaccine~     induced antibody response before and 2 to 4 weeks after immunization. Another blood draw will~     be obtained from up to 30 individuals from among the three groups for measures of T cell~     response to immunization. The third blood draw will be done during months 1 to 5 following~     influenza immunization. Genetic material (DNA) will be obtained from cells in the blood to~     look for genetic markers that may be associated with influenza vaccine response. Blood draws~     and immunization for the healthy participants will be done at the General Clinical Research~     Center (GCRC) or in the Clinical Research Facility in Rennebohm Hall. The blood draws for the~     pre-transplant and post-transplant patients will be coordinated with clinically indicated~     laboratory tests in order to avoid additional venipunctures. Influenza immunization is part~     of the routine clinical care of patients with lung disease, and only the immune response data~     will be considered part of the research study.~   "
255594|NCT00205257|"~     Acute rejection is still a major risk factor affecting the prognosis of kidney transplant~     patients. Alloreactive cells of the recipient infiltrate the kidney graft and cause~     inflammatory reaction which damages the graft structure and function. Conventional diagnosis~     of acute rejection is based on clinical symptoms and kidney biopsy examination. The clinical~     symptoms are a result of the kidney damage, which occurs days after the initiation of the~     rejection reaction. Kidney biopsy is an invasive and expensive procedure. It has been wished~     to have new parameters that can replace/supplement the conventional procedures. Chemokines~     are small molecules that attract inflammatory cells. Changes of chemokine levels in the urine~     may correlate with the immune status in the kidney. A systematic study to evaluate the~     chemokine levels in urine and correlation with the kidney biopsy pathology will answer the~     question whether monitoring of urinary chemokines would be useful in predicting graft~     rejection/damage.~   "
255620|NCT00204919|"~     Administration of vitamin D 50,000 units once monthly will:~        -  Maintain serum 25-OH vitamin D above 20 ng/ml~        -  Reduce falls~        -  Increase calcaneal BMD~        -  Reduce bone turnover~        -  Be well tolerated: volunteers will not develop hypercalcemia~        -  Improve performance on a swallowing quality of life questionnaire~   "
255595|NCT00205244|"~     Children scheduled for elective surgery are randomized into a control and intervention group.~     Children in the intervention group receive a CD and booklet of relaxation and distraction~     stories to listen to/read during the preoperative period. Preoperative anxiety is assessed by~     the child life specialist in the preoperative holding area. Ease of induction and emergence~     from anesthesia are rated by the anesthesia care provider. Post-hospital behaviors are~     reported by the parents one week after discharge. It is hypothesized that children receiving~     the intervention will have less anxiety, easier induction and emergence from anesthesia, and~     fewer changes in post-hospital behaviors than children in the control group.~   "
255596|NCT00205231|"~     This pilot study will investigate the safety and effect of etanercept in HIV infection by~     studying HIV replication and immune function (as measured by CD4 counts) in individuals with~     HIV infection.~   "
255597|NCT00205218|"~     The purpose of this study is to evaluate various methods for estimating body composition in~     human subjects. Each subject is evaluated by several methods that are then compared to a~     criterion value. We hypothesize that the prediction method will yield the same result as the~     criterion value. The risks to subjects are minimal and all techniques are routinely~     performed.~   "
255598|NCT00205205|"~     A peer mentoring program for persons with SCI was developed. Individuals who experienced SCI~     in the past and have adapted well functionally were asked to serve as mentors for individuals~     with newly-acquired SCI. These individuals undergo volunteer and peer mentoring training~     prior to mentoring activities. They are a subset of the study participants. We are tracking~     their satisfaction with life, positive and negative affect, life adjustment, depression, and~     social support over time. We hypothesize that measures of adjustment will become more~     positive as involvement as a mentor increases. The second subset of study participants are~     the individuals with newly-acquired SCI. They complete a baseline assessment of the measures~     listed above and then at 6 months, one year, and two years after match with a mentor. We also~     collect information about the quantity and quality of the mentoring sessions from both the~     mentor and mentee. We hypothesize that the mentee's adjustment will be positively influenced~     by the number and quality of the mentoring sessions. Due to the relatively small number of~     SCI per year in our program, we opted to offer the mentoring program to all individuals with~     newly acquired SCI, thus there is no control group.~   "
255599|NCT00205192|"~     Cardiac resynchronization therapy shows great promise as a method to improve ventricular~     function in heart failure due to dilated cardiomyopathy. It is applied to patients with class~     III and IV symptomatic heart failure on optimal therapy. Typical entry criteria in the trials~     testing resynchronization have used the electrocardiogram and a prolonged electrocardiogram~     (ECG) QRS interval as criteria for dyssynchrony. This is recognized to be quite limited as a~     tool for identifying patients. Several new echocardiographic methods for identifying~     dyssynchrony have been proposed. The purpose of this study is to systematically examine these~     multiple echocardiographic measurement techniques in three conditions:~        1. in the patient's native rhythm simulated by changing the pacing system to atrial pacing~          only;~        2. in conventional dual chamber pacing (DDD mode); and~        3. during biventricular pacing. All patients entered into this study will already have had~          a biventricular pacemaker placed.~   "
255600|NCT00205179|"~     The purpose of this pilot study is to evaluate the potential effects of soy isoflavone~     supplements on cognitive function for men and women with Alzheimer's Disease (AD).~     Preliminary studies evaluating the effects of soy supplements on memory in cognitively~     healthy older adults have yielded promising results that are now being evaluated in patients~     with AD. It is hypothesized that isoflavone supplements will ameliorate cognitive declines~     for older adults diagnosed with Alzheimer's disease, when compared to subjects on placebo.~   "
255601|NCT00205166|"~     We are studying the affect of caffeine on the sensitivity of detecting coronary artery~     disease (blockages in the blood flow to the heart) with adenosine tracer scans. Adenosine is~     a drug used routinely in patients to relax heart blood vessels in order to assess for the~     presence of coronary artery disease. Often, if patients have had caffeine, the adenosine scan~     is not used because of the belief that caffeine may reduce the ability to detect coronary~     artery disease. We would like to test whether caffeine affects our ability to detect coronary~     artery disease with adenosine tracer scanning. We will perform an imaging study of the heart~     with adenosine after you have received caffeine.~   "
255602|NCT00205153|"~     This Team Education and Adherence Monitoring (TEAM) trial will evaluate the~     cost-effectiveness of a pharmacy-based intervention in a randomized controlled trial~     involving 597 treated hypertensive African American patients in five Wisconsin cities. The~     study involves 28 community pharmacies (14 intervention, 14 control) owned by two pharmacy~     corporations. Intervention pharmacists and pharmacy technicians implemented a 6-month blood~     pressure (BP) monitoring program that involved working together as a team with patients and~     their physicians to achieve improved medication adherence, healthy lifestyles, drug therapy,~     and hypertension control.~   "
255603|NCT00205140|"~     What are the demographic and medication utilization characteristics of participants in the~     Senior MEDS personalized medication review compared to other community-dwelling elderly, what~     is the level of satisfaction with Senior Meds, and does the Senior Meds program lead to~     changes in the participants' drug regimen?~   "
255604|NCT00205127|"~     In this study we are looking at the blood flow to the heart using two different chemical tags~     or tracers that give off a low level of radiation. The tracers used in this study are called~     O15-water and F17-fluoromethane. These tracers mix with the blood and will move through the~     body. The researchers will use positron emission tomography (PET scans)to track the tracers~     as they moe through the heart and chest.~   "
255619|NCT00204932|"~     Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural~     sources. When given to small animals, decreases of body fat have been noted.. Although weight~     loss is the best treatment for overweight and obesity, it is difficult to maintain the loss~     in the long term. Because of this, treatment emphasis has turned to small weight losses~     obtained through non-restrictive diets and prevention of weight regain. This is a study to~     determine if 6 months of consumption a purified form of CLA will result in greater loss of~     body fat than control and to determine whether CLA consumption increases total fat oxidation,~     which would help explain why the weight loss occurs.~   "
255605|NCT00205114|"~     This 3-year collaborative project will develop, implement, and test a comprehensive approach~     to the prevention of falls among high-risk older adults in Dane County, Wisconsin through two~     complementary strategies:~        1. a targeted strategy of an individualized multifactorial intervention for~          community-living high-risk older adults. Older adults are defined as aged 65 and older.~          High risk is defined as two or more falls in the year prior, one fall with injury, or~          one fall with gait and balance problems, as per recent guidelines from the American~          Geriatric Society (AGS). The multifactorial intervention consists of an in-home~          assessment followed by recommendations to the participant and his/her physician, a~          prescription for physical therapy, other referrals (optometry, podiatry, occupational~          therapy, etc.) based on the assessment, monthly phone follow-up for 11 months, and a~          prescription for long-term exercise after physical therapy.~        2. a program to educate primary care physicians, physician assistants, nurse practitioners,~          and physical therapists in Dane County in the current diagnosis and treatment~          recommendations for fall prevention.~   "
255606|NCT00205101|"~     The purpose of the study is to prospectively measure pain, function, and patient satisfaction~     in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the~     Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF),~     transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF)~     surgeries. Patient participation is based on the physician determination that the patient~     requires one of these surgeries. Participants will be evaluated pre-operatively and~     post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to~     standard of care except for the completion of several study questionnaires:~        1. Back Pain Questionnaire;~        2. Oswestry Disability Index Questionnaire;~        3. Short Form-36 (SF-36) Survey;~        4. Visual Analog Pain Scale (VAS); and~        5. The Modems Patient Satisfaction Survey.~      Outcome Measurements:~        1. The patient's pain is scored by a VAS normalized to 100;~        2. Patient function is based on Oswestry scores;~        3. General health is assessed by SF-36 completion; and~        4. Overall patient satisfaction will be determined by the completion of the Modems.~   "
255607|NCT00205088|"~     The objective of the study is to test the sensitivity and specificity of a shunt tap to~     predict shunt failure.~   "
255608|NCT00205075|"~     The purpose of this study is to determine the effect of moderate alcohol intake on liver~     disease caused by HCV in terms of speed of progression as compared to those not drinking~     alcohol.~   "
255609|NCT00205062|"~     The main hypothesis is that PET-CT will be a valuable diagnostic tool in diagnosing and~     evaluating treatment for IBD.~   "
255610|NCT00205049|"~     The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to~     placebo in AAH while studying putative mechanisms that are plausible and testable. The main~     hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.~   "
255611|NCT00205036|"~     We, the investigators at the University of Wisconsin, hypothesized that ingesting calcium~     tablets prior to a spine bone density scan will not affect the bone mineral density as~     measured by dual energy x-ray absorptiometry (DXA).~   "
255612|NCT00205023|"~     The purpose of study is to: 1) determine critical volume necessary to overcome tubal pressure~     and result in fluid dissemination and 2) evaluate functional viability of any disseminated~     tumor cells collected during SHG~   "
255613|NCT00205010|"~     The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic~     ovarian transposition in women less than 40 years of age with locally advanced cervical~     squamous cell carcinoma~   "
255614|NCT00204997|"~     The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic~     ovarian transposition in women less than 40 years of age with locally advanced cervical~     squamous cell carcinoma~   "
255615|NCT00204984|"~     Does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a~     greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean~     pressure equally without improving aortic stiffness?~   "
255616|NCT00204971|"~     Nutrition is an important part of the recovery process after having a head injury so that~     subjects can gain strength and fight off infection. Liquid nutrition formulas are often given~     to patients through a tube that has been placed into the intestines for feeding when they are~     unable to eat on their own. Some reports suggest that nutrition with extra amounts of the~     amino acid called glutamine may decrease infections and hospital stay in severely injured~     patients.The purpose of this study is to evaluate if giving extra amounts of an amino acid~     called glutamine with liquid nutrition formulas will decrease the risk of infection and~     length of stay in the intensive care unit after having a head injury.~   "
255617|NCT00204958|"~     Nutrition is an important part of the recovery process after having a head injury so that~     subjects can gain strength and fight off infection. Liquid nutrition formulas are often given~     to patients through a tube that has been placed into the intestines for feeding when they are~     unable to eat on their own. Some reports suggest that nutrition with extra amounts of the~     amino acid called glutamine may decrease infections and hospital stay in severely injured~     patients. The purpose of this study is to evaluate if giving extra amounts of an amino acid~     called glutamine with liquid nutrition formulas will decrease the risk of infection and~     length of stay in the intensive care unit after having a head injury.~   "
255618|NCT00204945|"~     1. Research question: What is the response of the heart's pumping function to changes in~          heart chamber pressures?~        2. Experimental design: Patients undergoing routine cardiac catheterization will be~          studied. A thermodilution pulmonary artery catheter will be inserted through a venous~          sheath and threaded into the pulmonary artery. After several minutes of quiet rest,~          baseline hemodynamics will be obtained, including a determination of cardiac output~          using thermodilution techniques and 30 seconds of pressure recordings from the left~          ventricle and proximal aorta. In addition, a brief echocardiogram will be performed, to~          determine ejection fraction and indices of diastolic filling. Finally, arterial~          tonometry will be obtained in quick succession from the brachial, radial, femoral, and~          carotid arteries. Following the collection of baseline data, a bolus and infusion of~          nesiritide will be started. After 10 minutes of nesiritide infusion, with the drug still~          infusing, a full set of invasive hemodynamics will again be obtained, as well as brief~          echocardiographic and arterial tonometry examinations.~   "
255621|NCT00204906|"~     Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized~     that part of this neglect is due to absence of data documenting safe and effective ways to~     replete this inadequacy.~   "
255622|NCT00204893|"~     This is a Phase I, single center, open-label study of the dietary supplement calcium formate~     in normal, healthy female subjects. The purpose of the study is to determine whether daily~     use of calcium formate is safe and whether it accumulates in the eye.~   "
255623|NCT00204880|"~     Hypotheses:~        1. Subjective self-reported data can be used to accurately reflect functioning across the 5~          key domains.~        2. Cancer and its various treatment modalities will exert detrimental effects on the 5 key~          domains in older adults with cancer.~        3. Some aspect of baseline patient characteristic will be predictive of cancer-related~          outcomes.~   "
255624|NCT00204867|"~     This study involves a primary VC screening for colorectal polyps. The research hypothesis is~     that VC screening, including surveillance of sub-cm polyps, is a safe and effective approach.~   "
255625|NCT00204854|"~     Randomized controlled trial and benefit-cost study of a telephone and mail intervention for~     non-treatment-seeking primary care patients with alcohol abuse or dependence~   "
255626|NCT00204841|"~     Although asthma is likely to be a heterogeneous disease or syndrome, three factors and/or~     events repetitively emerge for their ability to significantly influence asthma inception in~     the first decade of life: immune response aberrations, which appear to be defined best by the~     concept of cytokine dysregulation; lower respiratory tract infections (in particular RSV);~     and some form of gene by environment interaction that needs to occur at a critical time~     period in the development of the immune system or the lung. It remains to be firmly~     established, however, how any one or all of these factors, either independently or~     interactively, influence the development of childhood asthma. Thus, our efforts to determine~     and define the importance of these three factors to asthma pathogenesis are the focus and~     goal of this current grant application.~   "
255627|NCT00204828|"~     This is an epidemiologic study, examining environmental exposures and affect on immune~     development.~   "
255628|NCT00204815|"~     What are the effects of the currently used AEDs on bone mineralization in children and~     adolescents between the ages of 8 to 18? This is a pilot observational study using DEXA scans~     to measure bone mineral density in 100 patients The primary objective is to collect~     preliminary data on bone mineral density, body weight, dietary calcium intake, and activity~     level.~   "
255629|NCT00204802|"~     Based on theories regarding decision-making and patient education the investigators have~     developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to~     improve patient and surrogate knowledge of ACP, increase the congruence between patient and~     surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making~     such decisions, and increase the consistency between patient preferences and the actual care~     they receive. The ACP intervention is conducted with the patient in the presence of the~     surrogate.~   "
255630|NCT00204789|"~     This is a double blind, placebo controlled study of 52 patients who are at least one-year~     post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The~     specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months~     and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate~     (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12~     months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12~     months of treatment.~   "
255631|NCT00204776|"~     Both capecitabine and oxaliplatin have single agent activity in breast cancer. The~     combination has improved activity in other solid tumors. This study seeks to assess the~     activity of the combination in breast cancer.~   "
255632|NCT00204763|"~     The primary objective of this study is to compare the accuracy of esophageal and anorectal~     manometric pressure measurements using a newly developed air filled balloon catheter with~     present standard solid state esophageal and anorectal catheters, respectively.~   "
255633|NCT00204750|"~     The primary objective of this study is to compare the efficacy of bougie dilation to~     electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the~     presence of rabeprazole treatment. All patients will be followed for one year for recurrence~     and/or severity of dysphagia and will be placed on rabeprazole for that time period.~   "
255634|NCT00204737|"~     The purpose of this study is to investigate if a 2-wk course of 20mg/day of oral prednisone~     in addition to standard care will result in reduced PTSD symptoms or symptom severity~     compared to placebo~   "
255635|NCT00204711|"~     The purpose of this study is to determine if the SNAP II electroencephalography (EEG) monitor~     accurately reflects changes in sedation level in outpatients undergoing surgery or procedures~     with sedation.~   "
255636|NCT00204698|"~     This study proposes to investigate prospectively, the presence of molecular markers for~     inflammation in laryngopharyngeal reflux (LPR) patients and to study the effect of a proton~     pump inhibitor (Aciphex) on these molecular markers.~      The investigators will be evaluating a group of patients before and after treatment. This~     group will be patients that have untreated laryngopharyngeal reflux diagnosed by~     laryngoscopic assessment and a 24-hour probe.~   "
255637|NCT00204685|"~     The purpose of this study is to determine whether Inhalation of Recombinant Human~     Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults~   "
255638|NCT00204672|"~     HYPOTHESIS~      Gastroesophageal reflux is a major contributor to exercise-triggered asthma.~      Two groups of patients will be studied: those with asthma who have difficulty with exertion,~     those without asthma who experience difficulty with exertion. Both groups will experience~     gastroesophageal reflux (GER) twice of less per week. Patients will complete a treadmill exam~     to determine their VO2 max. They will then undergo pH monitoring while exercising for 30~     minutes at 65-70% of their VO2 max. Subjects will be given placebo or acid suppression pill~     for 12 weeks. At the end of 12 weeks, the subjects will repeat the exercise (30 minutes) and~     24-hour pH study.~   "
255693|NCT00203944|"~     This study aims to provide information about the emotional and physiological responses of~     post-institutionalized children in both a stressful situation (immunization) and a play~     situation.~   "
255639|NCT00204659|"~     The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet~     been defined. In most circumstances, a stomach-conserving approach is favored, but the role~     of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP~     chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL.~     However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in~     March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with~     PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the~     safety and efficacy of this approach.~   "
255640|NCT00204646|"~     Complete resection is still the only curative treatment option in patients with soft tissue~     sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without~     evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant~     dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with~     non-resectable STS.~   "
255641|NCT00204633|"~     The aim is to determine the frequency of RBC transfusion in patients with metastatic poor~     prognosis germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without~     Darbepoetin alfa~   "
255642|NCT00204620|"~     The aims of this trial are to evaluate the efficacy of bendamustin in patients with~     metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd~     chemotherapy and to assess the treatment of toxicity.~   "
255643|NCT00204607|"~     vaccination protocol to induce specific immune responses against melanoma associated antigens~     by intradermal injections of mRNA coding for the corresponding antigen~   "
255644|NCT00204594|"~     Phase I/II clinical trial to analyze safety and efficiency of intralesional application of~     the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic~     melanoma stage III/IV and unresectable metastasis.~   "
255645|NCT00204581|"~     The intra-/perilesional application of interleukin-2 seems to be a safe and effective~     treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of~     intransit metastases the overall survival rate is still 20-30%.~      However, the management of intransit metastases is sometimes difficult because of frequent~     recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies~     indicate. In this study the safety and efficacy of IL-2 are evaluated.~   "
255646|NCT00204568|"~     The goal of this trial is to determine whether oral continuous (metronomic) therapy with~     trofosfamide results in a similar rate of progression-free time after 6 months as intravenous~     treatment with adriamycin. In addition, the study is intended to investigate the level of~     toxicity associated with the two treatment regimens (safety profile).~   "
255647|NCT00204555|"~     Results from a pilot study demonstrated that topical imiquimod could clear superficial and~     nodular BCCs. Three phase II dose response studies in subjects with nodular BCC (nBCC) showed~     that the histological cure rates with imiquimod depend on the doses applied per week and the~     duration of treatment. Daily dosing or 5 times per week applications showed higher total~     clearance rates than 3 times per week dosing or less frequent dosing. Furthermore, a 12 week~     treatment period resulted in better efficacy results than a duration of only 6 weeks. On the~     other hand, local skin reactions increased with the doses applied per week. So a prolonged~     treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be~     a good compromise between efficacy and safety.~   "
255648|NCT00204542|"~     Topical treatment of mild to moderate actinic keratosis located on the face and head with~     Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an~     expansion of the treatment period to 6 months will increase the rate of complete responses.~      Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic~     keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of~     treatment.~   "
255649|NCT00204529|"~     The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with~     pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant~     melanoma in stage IIA (T3a) - IIIB.~      A total of 880 will be randomized up to three months after first surgical management of their~     melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.~   "
255650|NCT00204516|"~     The purpose of the vaccination protocol is to induce specific immune responses against~     melanoma associated antigens by intradermal injections of mRNA coding for the corresponding~     antigen.~   "
255651|NCT00204503|"~     The purpose of this study is to determine if Divalproex Sodium can be used to Treat and~     Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol~     Dependence/Abuse.~   "
255652|NCT00204490|"~     Soy consumption has been associated with reduced risk for developing breast cancer. Soy~     contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing~     breast cancer risk are currently unclear. Breast density has been considered as a breast~     cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities,~     breast density and possibly bone density will be lower in women on soy-isoflavones.~   "
255653|NCT00204477|"~     Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian~     hormones and breast density are considered breast cancer risk markers. We propose to test the~     hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a~     corresponding reduction in breast density.~   "
255654|NCT00204464|"~     Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease MND) among~     adults. Motor neurons in the spinal cord, brain stem, and cerebral motor cortex degenerate~     and create a variety of upper (UMN) and lower motor neuron (LMN) clinical signs and symptoms,~     with the most frequently presenting symptom being focal weakness beginning in the leg, arm,~     or bulbar muscles, occurring in more than 70% of patients. Despite the high incidence of~     muscle weakness in patients with ALS, only two case studies evaluating the effects of~     specific muscle strengthening and endurance exercise programs in this patient population have~     been published, and the effects of resistive exercise programs in patients with ALS have not~     been well studied. Some have discouraged exercise programs in patients with ALS because of~     fear of overuse weakness. Yet, in patients with other neuromuscular diseases, resistive~     exercise programs have been shown to be beneficial and have not produced overuse weakness.~     The purpose of this study is to determine the effects of six months strengthening program on~     strength, function, fatigue and quality of life in individuals with ALS.~   "
255655|NCT00204451|"~     The researchers hypothesize that emergency contraception (EC) will initiate the changes~     associated with atresia or ovulatory failure at all stages of follicular development and that~     the image attributes associated with atresia will be similar regardless of the diameter of~     the dominant follicle when ovarian suppression is initiated. Second, changes associated with~     atresia may be observed, but ovulation of the dominant follicle is unimpeded.~   "
255656|NCT00204438|"~     We hypothesize that administration of OCs at varying follicular diameters will provide an~     appropriate model for the study of follicular atresia in women. Clinically, we hypothesize~     that the administration on OCs at different stages of the follicular phase will result in~     markedly different patterns of follicular development and/or atresia.~   "
255657|NCT00204425|"~     The purpose of the study is to determine the effectiveness of combining exercise training~     (i.e. weight lifting and walking) and dietary supplementation with a soy-based nutritional~     supplement for increasing bone mineral density. We hypothesize that the exercise training and~     soy-based supplement will be additive for increasing bone mineral density.~   "
255658|NCT00204412|"~     The purpose of our study is to use a flaxseed-based nutritional supplement in combination~     with exercise training (walking) for improving cholesterol levels. We hypothesize that~     exercise training will improve cholesterol profile and that adding supplementation with a~     flaxseed nutritional supplement will further improve cholesterol profile.~   "
255659|NCT00204399|"~     The purpose of this study is to systematically test the efficacy of two physician-based~     interventions in changing physical activity patterns of adults over a 20-month period.~   "
255660|NCT00204386|"~     The purpose of this study was to determine if Topiramate was safe and effective for use in~     civilian subjects with Posttraumatic Stress Disorder.~   "
255661|NCT00204373|"~     The purpose of this study is to study the safety and efficacy of high dose Prevacid in the~     long-term treatment of patients who secrete abnormally large amounts of gastric acid.~   "
255662|NCT00204360|"~     The purpose of this database is to collect information for clinical purposes on all children~     being treated for seizure disorders.~   "
255663|NCT00204347|"~     The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral~     dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings,~     impulsivity, thing difficulties and disturbed relationships. The secondary objective of this~     study (Study B)is to validate a self-report measure of clinical symptoms specific to the~     treatment of patients with BPD, the UAB Borderline Rating Scale(BRS).~   "
255664|NCT00204334|"~     Correction of anaemia in renal transplant recipients by parenteral application of recombinant~     erythropoietin and if necessary iron will improve large artery function (endothelial function~     and elasticity), as assessed by ultrasound techniques and applanation tonometry.~      The changes in large artery function will be reflected by changes in serological markers of~     endothelial function and oxidative stress and by changes in monocyte function and apoptosis.~      There are gender differences in the responses of vascular function to correction of anemia.~      Besides improvement of large artery function, correction of anemia will also affect~     parameters of graft function, i.e. glomerular and tubular proteinuria.~   "
255665|NCT00204321|"~     Chronic transplant nephropathy and cardiovascular death are the main reasons for loss of~     transplanted organs after kidney transplantation.~      Vascular changes, induced by hypertension and/or immunological processes, determine long time~     transplant survival.~      It will be tested whether the withdrawal of calcineurininhibitors will improve the vessel~     wall function in renal transplant patients. It is supposed that this immunosuppressive~     regimen reduces the activation of endothelial cells with important impact on arteriosclerosis~     and therefore on patient and transplant survival.~   "
255666|NCT00204308|"~     The purpose of this study is to determine whether the addition of tenofovir (TDF) and~     emtricitabine (FTC)to a standard PMTCT regimen containing single-dose nevirapine (NVP) can~     reduce the development of post-ingestion HIV resistance to non-nucleoside reverse~     transcriptase inhibitors (NNRTIs).~   "
255667|NCT00204295|"~     The purpose of this study is to determine the uptake of the amino acid~     O-(2-[F-18]Fluorethyl)-L-tyrosin (FET) in human brain tumors using positron emission~     tomography. A comparison to MRI and histopathological samples is used.~   "
255668|NCT00204282|"~     The purpose of the study is to evaluate the feasibility and efficacy of group visits led by~     nurse practitioners in improving diabetic preventive services and vascular risk. Diabetes is~     notable for its high burden on the health of urban populations, a rich literature supporting~     evidenced based care, and great opportunities to apply systemic primary care interventions to~     reduce its toll. Extensive literature demonstrates sub-optimal care in the community as well~     as in academic centers. Addressing the needs of patients with diabetes is challenging in the~     primary-care environment and nurse case management and disease-specific group visits which~     focus on education and self-management skills have been shown to be useful adjuncts to~     traditional outpatient care.~      The study will attempt to demonstrate that nurse practitioner run group visits, during which~     the NP will provide didactic education, facilitate group interaction, and arrange referrals~     and laboratory testing as appropriate, will improve compliance with established American~     Diabetes Association guidelines for screening and preventive care and in doing so lower~     cardiovascular risk. Satisfaction with care, quality of life, and diabetic knowledge will be~     assessed before and after the patients complete the program. In addition, we will attempt to~     characterize barriers to care for patients who were formerly established with a primary care~     physician in the Primary Care Group, but who have not received diabetic care there for at~     least one year.~   "
255669|NCT00204269|"~     The objective of the study is to examine the efficacy and tolerability of a~     three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's~     compliance. The replacement therapy will be performed with a new Testosterone Gel examined in~     previous trials as Testosteron Gel Wolff.~   "
255670|NCT00204256|"~     The objective of this study is the evaluation of the efficacy and safety of intravenous iron~     sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.~   "
255694|NCT00203931|"~     The purpose of the study is to determine in patients with Non Small Cell Lung Cancer~     refractory to previous chemotherapy whether concomitant treatment with cetuximab and~     pemetrexed improves progression-free survival compared with cetuximab monotherapy.~   "
255671|NCT00204243|"~     The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants~     as a relapse prevention for opiate addicted inmates about to be released from prison. The~     experimental group is compared with a control group that commences methadone maintenance~     treatment before release.~      The hypothesises are that quality of life and criminal behaviour improve significantly in~     both groups compared to the month before incarceration. The experimental group is going to~     have significant less days with opioid use compared to the MMT group.~      We hypothesize furthermore that the implants can prevent death related to opiate overdose up~     to 6 months after commenced treatment.~   "
255672|NCT00204230|"~     Prospective, randomised study: Effect of mycophenolatmofetil (MMF) and CNI withdrawal in~     patients with histologically proven chronic allograft nephropathy Indication: change in~     immunosuppressive treatment of chronic allograft nephropathy (CAN)after renal transplantation~     Hypothesis: Antimetabolite MMF is able to stop progression of CAN and improve blood pressure/~     metabolic parameters and structural vessel wall changes~      Primary Target:effects of CNI withdrawal and MMF on renal function: stabilisation and/or~     improvement Secondary Targets: Incidence of adverse events Evaluation of the calcineurin~     inhibitor free MMF treatment effects on blood pressure, lipids, glucose metabolism and on~     structural and functional vesselwallchanges Method:open prospective, randomized two-tailed,~     monocentric study~   "
255673|NCT00204217|"~     Airway control and ventilation is vital during cardiopulmonary resuscitation (CPR) in cardiac~     arrest. Endotracheal intubation is the gold standard for airway control, but several studies~     have shown high rates of unrecognized placements of the tube in the esophagus instead of in~     the airway out-of-hospital. This is lethal. There are no failproof technique for recognising~     such mistakes clinically in the cardiac arrest situation. Changes on the air volume in the~     lungs with ventilation changes the impedance (resistance to alternating current) through the~     thorax. This impedance is already measured routinely by the defibrillators used during CPR.~     We propose that we can measure ventilation volumes and also discover failed intubations by~     monitoring this impedance during CPR with the possibility of giving feedback on both to the~     rescuers.~   "
255674|NCT00204204|"~     The pupose of the study is a prospective evaluation of external and internal factors/causes~     of importance for the trauma and final outcome experienced by persons inside motor vehicles~     in serious car accidents. We hypothesise that there is an association between the use and~     function of safety features and the results for the patient and an association between~     material damage and the severity of injury.~   "
255675|NCT00204191|"~     The purpose of this study is to evaluate and compare, in the single center setting, the~     safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based~     on tacrolimus and cyclosporine.~   "
255676|NCT00204178|"~     Measurement of reactive oxygen species production and antioxidant system status before and~     directly after reperfusion of the transplanted kidney and influence of oxidant stress on~     kidney function in 2 and 6 weeks.~   "
255677|NCT00204165|"~     The purpose of this study is to compare MRI enteroclysis with MRI of the small bowel with a~     per oral 6%mannitol solution.Our hypothesis is that the peroral technique preform the same~     way as MRI Enteroclysis.~   "
255678|NCT00204152|"~     The purpose of this study is to test the clinical efficacy of two psychotherapies for early~     onset chronic major depression, including Behavioral Activation (Jacobson et al., 2001), and~     an integrated version of Behavioral Activation and Stress Innoculation Coping (BASIC) for~     short-term (16 weeks) of individual psychotherapy for adults with chronic major depression.~     The control condition is an individual workbook condition of Behavioral Activation. These~     psychotherapies focus on behavior activation, stress reduction and coping strategies to~     counter depressive symptoms.~   "
255679|NCT00204139|"~     It is debatable whether routine ultrasound scanning of pregnancies at about 20 weeks of~     pregnancy has substantive benefits for mothers and babies. Few studies have addressed this~     issue in poorly resourced settings. This trial will attempt to determine the benefits, if~     any, of a policy of routine ultrasound scanning of normal pregnancies versus a policy of no~     routine (only selective) scanning. This will be done by recruiting about 900 women in South~     Africa, and randomly allocating about half to routine scanning and half to selective scanning~     groups, and following up their pregnancies.~   "
255680|NCT00204126|"~     Treadmill therapy has the potential to improve the physical fitness and voluntary function of~     incomplete-lesion spinal cord injured (SCI) patients. However, if it is to be offered as a~     rehabilitation strategy, evidence must be gathered to support its effectiveness. Present~     methods used to determine the efficacy of treadmill training do not provide accurate means of~     monitoring changes in physical fitness during the exercise, or to accurately measure the~     changes in voluntary muscle function which may occur during a training intervention.~      We are therefore currently recruiting subjects for a study investigating the feasibility of~     new methods for monitoring improvements in physical fitness during walking on a treadmill. We~     also aim to develop methods for monitoring changes in voluntary muscle strength. The bone~     density of both legs will also be measured to determine if any improvement has occurred~     following training.~   "
255681|NCT00204113|"~     The study will investigate the feasibility of using functional electrical stimulation (FES)~     of the calf muscles of paraplegic subjects to assist in posture stabilisation during~     standing. We aim to achieve postural stability by combining controlled FES of the lower-limb~     muscles with the voluntary motor control skills of the intact upper body.~   "
255695|NCT00203918|"~     The purpose of this study is to help doctors and patients make better decisions about~     prostate cancer treatment. This research is being done because we do not know how patient~     preferences for health states related to prostate cancer affect the final treatment decision.~   "
255696|NCT00203905|"~     The primary objective of the study is to evaluate time to progression in eligible patients~     with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus~     when treated with the concomitant chemoradiotherapy regimen of bevacizumab/5-fluorouracil~     (5-FU)/hydroxyurea/radiation therapy (B-FHX) in comparison to 5-fluorouracil hydroxyurea~     (FHX) alone.~   "
255697|NCT00203892|"~     The purpose of this study is to determine whether the experimental vaccine modified CEA~     peptide CAP 1 -6D (mCEA) can produce an immune response in patients with pancreatic cancer~     who have received chemotherapy and radiation therapy.~   "
255682|NCT00204100|"~     Surface electrical stimulation has for many years been widely used to retrain paralysed~     muscle and achieve the functions of standing and stepping. Recently a number of centres have~     used electrical stimulation of the leg muscles to achieve cycling. During cycling the~     quadriceps and hamstring muscles (thigh muscles) (and sometimes also the gluteal (buttocks)~     muscles) are stimulated to obtain a cycling motion. Stimulation is applied using adhesive~     electrodes placed on the surface of the skin. This form of exercise is known as FES-cycling~     (FES = Functional Electrical Stimulation).~      We have recently carried out a pilot study which investigated the feasibility of lower-limb~     cycling using electrical stimulation. Cycling is accomplished using a standard recumbent~     tricycle, which is adapted for the purpose of FES cycling. Three people with a complete~     spinal cord lesion at level T7-T10 took part in the pilot study. The subjects are now able to~     cycle continuously and reliably on a tricycle mounted on a cycle trainer for periods of up to~     1 hour. The subjects are also able to cycle outside for distances of up to 3 km.~      The purpose of the new study is threefold: (i) We wish to develop the equipment and methods~     for recreational cycling to the stage of a pre-commercial design specification; (ii) The~     subjects recruited for the project will carry out a progressive, high-intensity~     cycle-training programme. In Glasgow, 5 paraplegic subjects shall complete the training~     programme, which will be based at their homes. This will allow us to fully assess the~     feasibility of recreational FES-cycling, by measuring the power which can be sustained during~     long periods of cycling, and to measure the impact of the training regime on their quality of~     life; (iii) We will determine whether the training regime leads to significant improvements~     in cardiopulmonary fitness, and therefore lower risk of heart disease, and to reductions in~     the likelihood of the development of pressure sores and fractures.~      We hope that this type of exercise will lead to general improvements in the fitness of people~     who might use the system in future.~   "
255683|NCT00204087|"~     The purpose of this randomized controlled trial is to develop a cognitive behavioral therapy~     (CBT) for persons with at risk mental states in the early initial prodromal state and to~     evaluate CBT in comparison to supportive counselling (SC).It is hypothesized that CBT is more~     effective than SC on transition to subthreshold psychosis, psychosis and schizophrenia as~     well as on prodromal symptoms and social adjustment.~   "
255684|NCT00204074|"~     The purpose of this study is to determine whether transdermally administered 17-beta~     estradiol sequentially could reduce the number of, and severity of, menstrual migraine~     attacks.~   "
255685|NCT00204061|"~     The study will provide an empirical basis for a pharmacological treatment option. An~     open-label, randomized, multi-centre parallel group design is used. An intensified clinical~     management (CM), which allows needs-based psychological crisis intervention, is compared to a~     combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is~     that the combination of a clinical management with an atypical neuroleptic is the superior~     treatment.~   "
255686|NCT00204048|"~     Care of hospitalized patients by hospitalists -- often defined as physicians who dedicate~     at least 25% of their practice to inpatient care -- is a recent, growing, and controversial~     trend in health care delivery in the United States. But despite the growth of interest in~     hospitalists, there have been few scientific evaluations of the concept. The comprehensive~     aim of this research study is to measure and analyze the effects of hospitalists on patient~     outcomes, costs and medical education on the general medical services of a group of academic~     centers.~   "
255687|NCT00204035|"~     The conceptual framework underlying the TEACH Research Program is based on a specific~     theoretical approach designed to influence adolescent career choice, in this case towards a~     career in clinical research. The factors responsible for influencing career choice that form~     the foundation for our investigation are: 1) the importance of role models in career choice;~     2) acquisition of knowledge in order to align ambitions; and 3) the participation of students~     in activities that actively challenge and engage them. These three factors are addressed by~     the following three components of the TEACH Research Intervention: 1) participation in a~     research team consisting of a multi-tiered structure of mentors; 2) classroom instruction of~     clinical research knowledge and career strategies; and 3) a hands-on clinical research~     experience through an internship on the Hospitalist Project.~      The evaluation of TEACH Research (Teaching Early Achievers for Careers in Health) aims to~     rigorously evaluate a precollege enrichment program in clinical research targeting high~     school students particularly underrepresented minorities, in order to increase the entry and~     success of these students into careers in clinical research. Through these measures, the~     TEACH Research Program will educate high achieving minority students and in turn hopefully~     encourage and promote these students to think about a career in clinical research.~   "
255688|NCT00204022|"~     The purpose of the study is to determine whether mycophenolate mofetil is superior to~     azathioprine to prevent flares of lupus nephritis.~   "
255689|NCT00204009|"~     The goal of this study is to investigate the epidemiology and natural history of~     childhood-onset diabetes, whether of autoimmune, non-autoimmune, or mixed etiology in~     affected probands and their relatives.~   "
255690|NCT00203996|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is~     usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and~     obesity. Women with PCOS suffer at an early stage of adulthood from all of the components of~     the metabolic syndrome, a syndrome that typically has its peak in mid-life in other subject~     populations. Women with PCOS are more insulin resistant than weight-matched control women and~     have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes,~     as well as a substantially elevated risk for hypertension, dyslipidemia, coronary, and other~     vascular diseases. While recent evidence indicates that the prevalence of sleep-disordered~     breathing (SDB) is 30-40 fold higher in PCOS than in weight-matched control women, the~     possible role of SDB in causing the increased metabolic and cardiovascular risks of PCOS has~     not been evaluated. The overall objective of the proposed study is to analyze the direction~     of causality between sleep disturbances and markers of the metabolic syndrome in PCOS.~   "
255691|NCT00203970|"~     The purpose of this research is to gain insight into the way in which physicians adopt new~     practice techniques. In particular, we are interested in how medical innovations diffuse~     throughout social networks. We wish to examine the diffusion of Low Molecular Weight Heparin~     (LMWH) use for Deep Vein Thrombosis (DVT) throughout the social network of general internal~     medicine interns, residents, and attendings at the University of Chicago Hospital. In~     numerous clinical trials, LMWH has been demonstrated to be as effective as unfractionated~     heparin as a bridge to long-term anticoagulation therapy with Coumadin, with the added~     benefit of early discharge from the hospital with easy dosing, no need for monitoring, and~     home therapy. A DVT critical pathway was established at the U of C in 1998, and LMWH was used~     off-label for that purpose beginning in 1997. However, it is unclear how quickly the use of~     LMWH was adopted by the physicians on the general medicine services, or whether there exists~     a pattern for this adoption.~   "
255692|NCT00203957|"~     The purpose of this study is to confirm the long term tolerability and safety of oral 20 or~     40 mg/d doses of Istradefylline.~   "
255698|NCT00203879|"~     Purpose of investigation: Primary hypotheses: Immunization of patients with 4 melanoma~     antigen peptides will induce augmented specific IFN-y-producing CD8+ T cells against all 4~     antigens simultaneously. Immunization with 4 melanoma antigen peptides will increase the~     response rate from 10% to 30%. Administration of low-dose IL-2 following each vaccine will~     result in a greater than 3-fold increase in specific T cells compared to no IL-2.~      Secondary hypotheses: Immunization will clear the blood of detectable circulating melanoma~     cells. Tumors that grow despite induction of melanoma antigen-specific T cells may lack~     expression of antigens, class I MHC, or the TAP peptide transporter, or may fail to show~     increased expression of mRNA for IFN-y or perforin. Tumors that resist vaccination may~     express a different array of genes than those that are susceptible to vaccination.~   "
255699|NCT00203866|"~     The purpose of this study is to determine whether the experimental vaccine G250 with or~     without IL-2 can produce an immune response in patients with renal cell carcinoma who have~     had all their cancer removed by surgery.~   "
255700|NCT00203853|"~     It is known successful HIV therapy depends on the patients' ability to take their medicine~     regularly. This study is designed to find out if an intervention designed to help patients~     remember to take their medication is effective. The intervention consists of a wristwatch~     that has an alarm to remind patients when to take their medication, a pillbox and three~     monthly phone calls by a physician. All these experimental measures are meant to improve the~     ability of patients to take their medicines.~   "
255701|NCT00203840|"~     The information gathered from normal pediatric patients seen at the Pediatric Neurology~     Clinic in the DCAM and LaRabida Children's Hospital will be used to standardize and validate~     the information gathered from pediatric patients with sleep disorders. This will serve as the~     information source for a pediatric sleep database.~   "
255702|NCT00203827|"~     The purpose of this study is to develop a questionnaire that can be used for standardized~     patient information gathering in the clinical setting. This will serve as the information~     source for a pediatric sleep database.~   "
255703|NCT00203814|"~     The purpose of this study is to determine the efficacy of sulfadoxine-pyrimethamine plus~     artesunate versus sulfadoxine-pyrimethamine alone in the treatment of uncomplicated malaria.~   "
255704|NCT00203801|"~     The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own~     and compare this with efficacy of a new combination antimalarial therapy, either~     sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.~   "
255705|NCT00203788|"~     This study will determine the effectiveness of combining antipsychotic medication with~     Individual Placement and Support (IPS) and group training with the Workplace Fundamentals~     Module or Brokered Vocational Rehabilitation in facilitating the search for appropriate work~     or schooling and maintaining work or school activities in people with recent-onset~     schizophrenia.~   "
255706|NCT00203775|"~     This study examines the efficacy of haldol versus risperdal in the treatment of aggression in~     psychotic prison inmates. It is hypothsized that risperdal will be more effective in~     decreasing aggression than haldol.~   "
255707|NCT00203762|"~     A scale-up of public sector antiretroviral treatment (ART) programmes may divert scarce~     resources from other priority primary care programmes like tuberculosis and childhood~     immunization.~      The purpose of this study is to compare the performance of tuberculosis (TB) and childhood~     immunization programmes in primary care facilities participating in the South African~     national antiretroviral treatment programme with those which have yet to be included in the~     ART programme.~   "
255708|NCT00203749|"~     This study will evaluate the effectiveness of a combination of clinic- and community-based~     voluntary counseling and testing programs in preventing HIV in African and Thai communities.~   "
255709|NCT00203736|"~     The purpose of this study is to compare the efficacy of sulfadoxine-pyrimethamine plus~     artesunate with that of sulfadoxine-pyrimethamine on its own for the treatment of~     uncomplicated malaria.~   "
255710|NCT00203723|"~     The purpose of this study is to determine if the combination of risperidone and ECT improves~     a patient's response in depression compared to ECT alone.~   "
255711|NCT00203710|"~     The primary purpose is to study the safety and effectiveness of the Concentric Retriever~     Device(CRD)in ischemic stroke patients who undergo clot retrieval with the CRD within 8 hours~     of stroke symptom onset. The CRD has been approved by the U.S. Food and Drug Administration~     to retrieve foreign bodies (such as pieces of metal) from blood vessels in the body. The CRD~     is a small metal wire with a loop at the end (like a corkscrew) that removes clots from~     arteries and thereby restores blood flow to the brain. Prior versions of the CRD may have~     been too soft to pull out clots, just as a corkscrew that is too soft would not pull out~     corks. The current version of the CRD is not as soft and may be more effective in retrieving~     clots. Hypothesis: By restoring blood flow to the brain, stroke symptoms may get better or~     the stroke may be prevented from getting worse.~   "
255712|NCT00203697|"~     Pulmonary fibrosis is essentially scarring in the lungs. Some types (DIP, NSIP) most often~     respond to therapy. Others like UIP (usual interstitial pneumonitis) rarely respond. UIP~     frequently progresses and has a poor prognosis with a survival of three to five years. In~     UIP, most often the cause cannot be determined and is therefore called Idiopathic Pulmonary~     Fibrosis (IPF). A prevalence rate of 27–29 cases/100,000 has been reported that may even be~     as high as 250 cases/100,000 in individuals 75 years of age.~      Idiopathic pulmonary fibrosis (IPF) is a chronic and fatal pulmonary disorder. Conventional~     treatment with immunosuppressive therapy has been disappointing, with a median survival of~     <40% at five years after diagnosis. Moreover, this therapy may lead to premature deaths that~     are a result of immunosuppression and susceptibility to infectious disease. Another problem~     related to IPF, is that we have an incomplete picture of the natural history of the~     pathogenesis of this disorder. Clearly, new strategies for therapy are necessary.~      Published evidence suggests that less than 20% of patients with IPF respond to~     corticosteroids (prednisone). In patients that fail steroids, immunosuppressant drugs such as~     azathioprine or cyclophosphamide are used. An international consensus statement recommends~     both steroids and azathioprine or cyclophosphamide from the onset of treatment. Unfortunately~     a large number of trials have shown little or no effect of these drugs on the progression of~     disease. There are currently no FDA approved drugs for the treatment of IPF.~      Laboratory findings establish that human specimens of Interstitial Lung Diseases including~     IPF demonstrate an impalance in expression of proteins (Th2 Cytokines, CC Chemokines, and CXC~     Chemokines). When these protein levels are in excess or low, they alter the normal lung~     mechanism, causing angiogenesis (abnormal blood vessel formation), inflammation, scar tissue~     formation and impaired immunity of the patient. We hope to establish that the efficacy of~     anti-angiogenetic agent as an add on therapy for IPF patients, will prove to bring~     stabilization or improvement.~      Minocycline has been shown to inhibit angiogenesis (new abnormal blood vessel formation) and~     thus affect the fibrotic process (prevent scar tissue formation). Laboratory and animal~     studies support a potential therapeutic role for Minocycline in IPF.~      Minocycline is a semi synthetic derivative of tetracycline. It was first marketed as an~     antibiotic in 1972. Clinical trials of minocycline have mainly been performed in sexually~     transmissible diseases and in acne. Minocycline is also used to treat several other diseases~     such as nocardiasis, mycobacteriosis, leprosy, lyme disease, pyoderma gangrenosum, autoimmune~     bullous dermatitis, carteaud disease, and prurigo. The usual side effects of minocycline are:~     lightheadedness, dizziness, or vertigo and pigmentation.~      We will investigate genetic, molecular, cellular, whole animal models, and human specimens~     from patients with fibrotic lung disease to test our prediction: The pathogenesis of~     pulmonary fibrosis (lung scarring) is due to “multiple hits” that causes an inbalance of~     certain mediators (proteins) that are responsible for abnormal blood vessel formation, scar~     tissue formation (with and without inflammation inside the lungs) and impaired immunity of~     the patient. Each of the 3 projects in this proposal have a direct link to other projects and~     clinical core. The SCOR clinical core will identify and enroll patients with Interstitial~     Lung diseases (ILD), including IPF. The clinical core will collect clinical data, as well as~     obtain fluids from lung washings and human lung tissue specimens. Each project will use human~     specimens as indicated in each of their specific aims to correlate their findings with~     response to therapy.~   "
255713|NCT00203684|"~     Asthmatics have inflammation in the large airways (tubes through which air travels in and out~     of the lungs). The large airways are located in the central lung. New research shows that~     asthmatics also have inflammation in the small airways. The small airways are located in the~     peripheral lung (the parts of the lung away from the central lung).~      Until now, most of the inhaled medications available have been made up of big particles that~     never reach the peripheral lung. The purpose of this study is to try to measure the level of~     inflammation in the peripheral lung in asthmatics and see if this inflammation can be~     decreased with different types of inhaled corticosteroids. The investigators will check~     airway inflammation before and after use of an inhaled corticosteroid that has a large~     particle size and should only reach the large airways (Flunisolide-CFC), and before and after~     use of an inhaled, small particle corticosteroid that should reach both the large and small~     airways (Flunisolide-HFA).~      Subjects will make 6 study visits over two phases of the study. In the first phase, the~     investigators will collect baseline information about subjects while they are using placebo~     (inactive substance). In the second phase, subjects will take either the large or small~     particle corticosteroid.~      Visits will involve questionnaires and various tests measuring lung function (such as~     spirometry, forced oscillation, and methacholine challenge). Exhaled nitric oxide will be~     measured as an indication of inflammation. Subjects will also measure and make note of lung~     function at home twice daily using a peak expiratory flow meter. Two of the visits will~     involve fiberoptic bronchoscopy so that the investigators may collect cells and tissue~     samples without surgery. Another two of the visits will involve the use of high resolution~     computed tomography (HRCT) scans to indirectly evaluate disease in distant parts of the~     lungs.~   "
255714|NCT00203671|"~     The purposes of this study are:~        -  To review past clinical use of mycophenolate mofetil (MMF) in kidney transplant~          patients;~        -  To discover why doses were modified and how those modifications affected the survival~          and health of the transplanted kidney; and~        -  To determine whether, therefore, the side effects of MMF that result in dose alterations~          are related to outcome.~   "
255715|NCT00203658|"~     The purpose of this study is to assess the long-term out-of-hospital treatment of patients~     with proximal venous thrombosis through the administration of subcutaneous~     low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed~     by warfarin sodium.~   "
255716|NCT00203645|"~     The purpose of the study is to examine whether problem gamblers who receive therapy calls in~     addition to a self-help manual will be more likely to quit or cut back on their gambling when~     compared with problem gamblers who receive just the manual.~   "
255717|NCT00203632|"~     The purpose of the study is to determine if the addition of rosiglitazone to subjects with~     fair glucose control on other oral agents improves endothelial function, a surrogate marker~     of vascular health.~      It is hypothesized that improving whole body insulin sensitivity with combination therapy~     including rosiglitazone will restore the vascular actions of insulin and improve~     endothelium-dependent vasomotion more effectively than placebo in patients with diabetes~     mellitus.~   "
255718|NCT00203619|"~     The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule~     endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To~     inform this analysis, a randomized controlled trial of capsule endoscopy compared with~     standard care will be conducted~   "
255719|NCT00203606|"~     Hepatitis C infects as many as 300,000 Canadians. Up to 25% of those infected will develop~     cirrhosis and be at risk for liver failure and liver cancer. Cirrhosis caused by hepatitis C~     is the most common reason for liver transplantation in Canada. The largest group of infected~     people are those who use injectable street drugs. However, people who continue to use drugs~     are routinely excluded from scientific studies testing new treatments for Hepatitis C and are~     generally recommended not to receive available treatments. Although several reasons are given~     to justify excluding these people from treatment, little scientific evidence is available to~     support it. We plan to examine how successful treatment with the current standard treatment~     of pegylated interferon and ribavirin is in those who continue to use injection drugs. We~     will compare the results of treatment of 70 active drug users to results of published~     clinical trials (this is a change from initial plan to compare to treatment results of 70~     local) reformed drug users). Our goal is to determine whether reasonable success rates can be~     achieved in active drug users that would then further justify their routine treatment.~   "
255720|NCT00203593|"~     The purpose of this study is to determine whether eight weeks of exercise performed at an~     intensity of approximately 65% VO2max will improve symptoms associated with fainting~     (vasovagal syncope).~   "
255721|NCT00203580|"~     The purpose of this study is to assess the long-term treatment of patients with proximal~     venous thrombosis through the administration of subcutaneous low-molecular-weight heparin~     (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral~     warfarin sodium.~   "
255722|NCT00203567|"~     To study the efficacy and safety of beaded extended-release Carbamazepine (Equetro) in the~     treatment of patients with Bipolar Disorder with a Major Depressive Episode.~   "
255723|NCT00203554|"~     The purpose of this study is to compare the effect of vertebroplasty with that of traditional~     medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.~   "
255724|NCT00203541|"~     The primary objective of this pivotal study is to determine if a new antimicrobial dressing,~     applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased~     cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional~     site as compared to the control group, regular, non-antimicrobial dressing.~   "
255725|NCT00203528|"~     The primary objective is to evaluate the safety and efficacy of divalproex extended release~     (ER) compared to risperidone in the treatment of bipolar disorder with comorbid substance use~     disorder~   "
255726|NCT00203515|"~     The purpose of the study is to determine if the commercially available device called the~     DOVER™ Silver Foley catheter prevents infections of the urinary tract.~   "
255727|NCT00203502|"~     The main purpose of this study is to find out what effects taking the drug bevacizumab~     together with two chemotherapeutic agents, docetaxel and cyclophosphamide followed by~     doxorubicin alone before surgery will on breast cancer. Bevacizumab will be given for twelve~     weeks in combination with chemotherapy then it ill be held during the administration of~     doxorubicin. Twenty-eight to fifty-six days after undergoing surgery, all patients will~     receive nine three-weekly infusions of bevacizumab.~   "
255728|NCT00203489|"~     The purpose of this study is to determine if a new antimicrobial gauze dressing is better~     than the current method of dressing open wounds with plain sterile gauze. It is hoped that~     the antimicrobial gauze will reduce the number of germs in the open wound and even improve~     the rate of healing.~   "
255729|NCT00203476|"~     To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA~     Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or~     niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol~     Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density~     lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures~     examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis.~     High-density lipoproteins (HDL) elevations are monitored between the three groups to~     determine efficacy as a secondary outcome.~   "
255730|NCT00203463|"~     To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.~   "
255731|NCT00203450|"~     The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg~     - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a~     body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of~     weight gain.~   "
255732|NCT00203424|"~     The purpose of this study is to evaluate the safety and effectiveness of bevacizumab plus~     erlotinib following radical prostatectomy.~   "
255733|NCT00203411|"~     The purpose of this study is to evaluate the safety and effectiveness of the bevacizumab and~     capecitabine combination in frail patients with untreated metastatic colorectal cancer.~   "
255734|NCT00203385|"~     The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote)~     in the continuation treatment of PTSD.~   "
255735|NCT00203372|"~     The purpose of this study is to evaluate the safety of the TAC-bevacizumab combination and~     investigate whether changes in gene expression, or the expression of specific biomarkers, are~     either predictive of response to bevacizumab or indicative of response.~   "
255736|NCT00203359|"~     It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been~     implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised~     to be of potential benefit for treating AD.~   "
255737|NCT00203346|"~     Migraine and the skin sensitivity that accompanies it can go away in minutes after a nerve~     block, which is a procedure involving an injection of a small amount of a local anesthetic~     next to a nerve to the skin, causing an area of skin to become numb. We have also noticed~     that light sensitivity goes away quickly after a nerve block. We would like to see how~     quickly this happens and how long the benefit of nerve block lasts. We are interested to see~     if these effects are due to the injection itself or due to the lidocaine.~      A subject may be asked to participate in this study if a subjects physician has planned for a~     subject to receive an injection of BOTOX® in the area of the Greater Occipital Nerve (a~     spinal nerve located at the back of the head) as part of a subjects routine preventive~     treatment for migraine today.~   "
255738|NCT00203333|"~     People with epilepsy are at a higher risk for sudden unexpected death than the general~     population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this~     population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is~     particularly high for those with refractory epilepsy. Several lines of evidence support a~     cardiac mechanism for SUDEP.~      This study plans to determine:~        1. the frequency and types of cardiac arrhythmias that occur in this population and~        2. whether these are increased above the general population in the same age group.~      Additionally, these data will be correlated to specific clinical data, including seizure~     history, anticonvulsant medications, and any accompanying clinical symptoms.~   "
255739|NCT00203320|"~     It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been~     implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised~     to be of potential benefit for treating AD.~   "
255740|NCT00203307|"~     Olanzapine (o-lan-zah-peen) is a medication that has been approved by the Food and Drug~     Administration (FDA) for the treatment of patients with schizophrenia and/ or bipolar~     disorder. The trade name for this drug is Zyprexa®. Olanzapine has not been approved by the~     FDA for the prevention of migraine and is experimental for the purposes of this research~     study.~      The Jefferson Headache Center at Thomas Jefferson University has developed this clinical~     study to evaluate the safety and effectiveness of Olanzapine in preventing migraine~     headaches.~   "
255741|NCT00203294|"~     Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for~     your chronic daily headache (CDH). GONB has been used for many years in the treatment of~     headaches. The nerve block is done by injecting a liquid drug through the skin of the back of~     the head to the area of the greater occipital nerve. The nerve runs superficially in this~     area, therefore the drugs are injected just under the skin. The injected drugs block~     electrical transmission through the nerve, resulting in reduced head pain. There are~     treatment options for patients receiving a GONB, however, some clinicians use local~     anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local~     steroid injection. The purpose of this study is to evaluate whether or not there is an~     observed difference between these two treatment approaches for GONB. We expect to enroll 60~     patients into this research study at Thomas Jefferson University only.~   "
255742|NCT00203281|"~     Based on the limited amount of experience with plasmapheresis and CytoGam concomitant use,~     the researchers seek to evaluate the pharmacokinetics (drug absorption, distribution, and~     elimination) of this therapy. The researchers are also interested in evaluating the~     pharmacokinetics of the various immunosuppressant medications that patients will receive such~     as tacrolimus, mycophenolate mofetil and daclizumab.~   "
255743|NCT00203268|"~     This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It~     will be used to treat two migraine attacks in subjects who have a history of skin sensitivity~     associated with their headaches.This skin sensitivity is called cutaneous allodynia~     (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a~     non-noxious stimulus is applied to normal skin. It has been noted in several studies that in~     subjects with migraine, seventy nine percent of the subjects experienced allodynia on the~     facial skin on the same side as the headache. It has also been shown that that once allodynia~     develops, other migraine medicines that would normally be very effective for migraine pain,~     become much less effective or ineffective. This study will compare the differences,if any, in~     attacks treated early with this study drug and treated later with the same study drug. It is~     hoped that that this trial will provide information on the use of DHE-45 in subjects who have~     cutaneous allodynia. Understanding more about allodynia may help us understand how the pain~     system works in migraine.~   "
255744|NCT00203255|"~     The purpose of this trial is to study the use of soy isoflavones in the prevention of~     menstrually-associated migraines. Additionally, this trial may provide insight into the~     menstrual cycle and menstrually-related headaches in women. With this information, we may be~     able to change current treatment methods or even develop new methods in order to advance~     current approaches in the treatment of menstrual migraine.~   "
255745|NCT00203242|"~     The purpose of this study is to collect and evaluate information on the use of Depakote~     Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches.~     Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV~     Depacon followed by oral Depakote ER. Patients will receive a total of 1,000mg of Depacon and~     1,000mg of Depakote ER each day. Patients may have a 3rd day of IV Depacon followed by oral~     Depakote ER if the primary investigator believes it to be beneficial. The patient is then~     sent home on oral Depakote ER. The dose of Depakote ER can range from 500mg to 2,000mg this~     dose is to be determined by the primary investigator. The patient will continue the oral~     Depakote ER until the end of their cluster cycle or for a maximum of 6 weeks, which ever~     comes first.~   "
255746|NCT00203229|"~     This research study will look at the safety (e.g., the occurrence of side effects) and~     efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called~     lamotrigine in adults with trigeminal neuralgia.~   "
255747|NCT00203216|"~     The study drug levetiracetam is FDA approved as an add-on medication in the treatment of~     partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an~     open-label trial, which means that all participating patients will receive active study~     drug.~      The Jefferson Headache Center has developed this clinical study to evaluate the safety and~     effectiveness of levetiracetam in preventing migraine headaches, with or without aura (visual~     disturbances).~      In addition, the study site will be performing a procedure called Transcranial Magnetic~     Stimulation (TMS). This procedure measures brain activity because it is thought that people~     with migraine experience periods of cortical hyperexcitability or over-activity in the brain.~     This information may help physicians in the future determine which preventive medications~     will work for which patients.~   "
255748|NCT00203203|"~     This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear~     stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular~     Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion~     criteria, and no exclusion criteria are found, the subject is consented for the study, and~     extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline~     testing criteria is met, the patient has their own bone marrow harvested and later that day~     the subject is taken to a cardiac catheterization lab where left ventricular~     electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed~     stem cells are injected under electromechanical guidance into the affected areas of the left~     ventricle. The patient is usually discharged home the next day and returns for follow up~     visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4,~     5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits,~     including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell~     injection.~   "
255749|NCT00203190|"~     Topiramate is a medication that has been approved by the Food and Drug Administration (FDA)~     for the treatment of patients with seizures. The trade name for this drug is Topamax®.~     Topiramate has not been approved by the FDA for the treatment of cluster headache and is~     experimental for the purposes of this research study. If a subject participates in this~     study, he/she will increase his/her dose of topiramate rapidly in the first few weeks to try~     to stop the cluster attacks and then will continue on a maintenance dose of topiramate in~     order to determine if it can prevent attacks from occurring during that cluster period. We~     believe that this will lead not only to a faster but a more complete remission of the cluster~     period.~   "
255750|NCT00203177|"~     Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5~     mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with~     Levodopa/Carbidopa therapy.~   "
255751|NCT00203164|"~     This is a study to look at the effectiveness, tolerability, and safety of one dose of~     rasagiline in advanced Parkinson's disease (PD) patients who have been treated with~     Levodopa/Carbidopa therapy.~   "
255752|NCT00203151|"~     It is thought that Edratide may be able to reduce the symptoms of SLE.~   "
255753|NCT00203138|"~     Patients who completed the study TVP-1012/232 are eligible to enter the extension study to~     continue their rasagiline therapy for their Parkinson's disease (PD). During this study the~     patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be~     monitored.~   "
255754|NCT00203125|"~     This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg~     of Rasagiline or Placebo~   "
255755|NCT00203112|"~     This study investigates the add-on effect of oral minocycline in subjects treated with daily~     injection of Copaxone. Copaxone and minocycline are thought to have differential modes of~     actions that may complement each other in treating MS symptoms.~   "
255756|NCT00203099|"~     This study evaluates the effect of the therapy combining GA and NAC on disease activity as~     reflected by MRI parameters while assessing tolerability and safety.~   "
255757|NCT00203086|"~     It is thought that treating Multiple Sclerosis with Novantrone for a short period of time~     prior to treatment with Copaxone may enhance the onset effect of Copaxone.~   "
255758|NCT00203073|"~     It is thought that treating multiple sclerosis with Novantrone for a short period of time~     prior to treatment with Copaxone may enhance the onset effect of Copaxone.~   "
255759|NCT00203060|"~     Study to look at the effectiveness, tolerability and safety of two doses of Study Medication~     in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.~   "
255760|NCT00203047|"~     This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and~     add-on pulse steroids.~   "
255761|NCT00203034|"~     Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either~     Rasagiline or Placebo~   "
255762|NCT00203021|"~     Patients have scheduled visits every 3 months to assess Copaxone safety and their Multiple~     Sclerosis status.~   "
255763|NCT00203008|"~     Patients with Parkinson's disease will be seen by a dermatologist who will biopsy any~     suspicious skin lesions.~   "
255764|NCT00202995|"~     Randomized study designed to look at the difference in relapse rates between patients~     remaining on their current interferon medication and those switched to Copaxone®~   "
255765|NCT00202982|"~     This is a study to test if a new higher dose of Copaxone is more effective in treating~     relapsing-remitting multiple sclerosis than the currently available 20 mg dose.~   "
255766|NCT00202969|"~     This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating~     the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared~     with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with~     chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A),~     S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced~     distribution of patients to each arm according to following stratifications, performance~     status (0, 1, or 2), the number of metastatic sites (1 vs >1), prior gastrectomy, and center.~   "
255767|NCT00202956|"~     The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal~     patients with osteoporosis.~   "
255860|NCT00201734|"~     This study will determine the maximum tolerated dose of the triplet combination of~     capecitabine that can be administered in combination with weekly paclitaxel and every four~     weeks with carboplatin.~   "
255768|NCT00202943|"~     We hypothesis that radiofrequency will cause less post-operative discomfort when compared~     with laser assited uvulopharyngoplasty. 40 patients with primary snore will be enrolled into~     this study. After overnight sleep test confimred that no obstructive sleep apnea existed,~     cases were informed consented. Then they were randomized into two groups. Post-operative~     pain, duration of analgesics were recorded.~   "
255769|NCT00202930|"~     The purpose of this study is to evaluate the feasibility of giving four weekly doses of~     Rituximab (anti-CD20 antibody) in the treatment of children with refractory neuroblastoma~     associated opsoclonus-myoclonus. Patients must have continued symptoms of opsoclonus,~     myoclonus and or ataxia despite surgical resection and a minimum of one month of steroid~     therapy. Evaluations include clinical symptoms of opsoclonus-myoclonus and ataxia as well as~     detailed evaluation of learning and development.~   "
255770|NCT00202917|"~     The purpose of this study is to study the feasibility and Toxicity of allogeneic~     haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a~     dose reduced conditioning.~   "
255771|NCT00202904|"~     This is a multicenter, randomized, parallel group, placebo controlled study designed to~     evaluate the efficacy, safety, and tolerability of ezetimibe added to ongoing atorvastatin~     therapy compared with ongoing atorvastatin treatment alone. This study will involve subjects~     with primary hypercholesterolemia and coronary heart disease (CHD) who are currently being~     treated with atorvastatin and who would benefit from additional reduction in low-density~     lipoprotein cholesterol (LDL-C).~   "
255772|NCT00202891|"~     This open-label, randomized, parallel-group clinical study is designed to compare the~     efficacy and safety of the topical antibiotic, sisomicin cream, with that of another topical~     antibiotic cream, nadifloxacin cream, in the treatment of Indian patients with primary~     pyodermas.~   "
255773|NCT00202878|"~     This is a randomized, active-control, double-blind study of subjects with stabilized~     high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical~     benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in~     the United States) compared with Simvastatin 40 mg. As per the original protocol, if~     low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin~     in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011~     protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new~     increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the~     reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV)~     death, major coronary events, and stroke.~   "
255774|NCT00202865|"~     This is a randomized, double-blind, multi-center, placebo-controlled study with two parallel~     treatment groups (placebo and infliximab) in subjects with ankylosing spondylitis (AS) to~     evaluate the efficacy of infliximab 3 mg/kg.~   "
255775|NCT00202852|"~     Prior to the first infusion, patients will be randomized into one of two groups (placebo or~     infliximab). All patients will continue to receive the same does of methotrexate (MTX) during~     the study as received prior to the study. The objective of the study is to evaluate the~     efficacy and safety result of infliximab with Korean patients in reducing clinical signs and~     symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to~     review whether the result is comparable to the result of the ATTRACT trial.~   "
255776|NCT00202839|"~     This is an open-label, randomized, comparative, multicenter, 48-week study designed to~     evaluate the efficacy and safety of combination treatment with pegylated interferon and~     ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C~     virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24~     weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects~     will be randomly assigned to one of two study groups. One group will be followed for an~     additional 48 weeks without study medication, while the other will be continuously treated~     for an additional 24 weeks and then followed for another 24 weeks without study medication.~     Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the~     follow-up period, will be measured along with other outcomes.~   "
255777|NCT00202826|"~     The purpose of this study is to determine the best treatment for children with a fluid~     collection in the chest associated with an underlying pneumonia. Researchers generally agree~     that a child with a large fluid collection in the chest need to have the fluid drained in~     addition to anitbiotics. There have been many treatments studied in children that have been~     shown to be effective and safe, but the treatments have never been compared to each other in~     a randomized controlled study.~      The optimal treatment of pediatric parapneumonic effusions remains controversial. The~     objective of this study is to compare the use of conventional management (antibiotics with~     thoracostomy tube placement) with primary thorascopic drainage (see protocol). Our hypothesis~     is that pediatric patients with parapneumonic effusion, regardless of pleural fluid~     composition and loculations, have decreased morbidity when treated with early thoroscopic~     adhesiolysis (VATS) compared with conservative treatment.~   "
255778|NCT00202813|"~     This study should help determine to determine whether or not the use of an antibiotic coated~     catheter will significantly reduce the number of central line related bloodstream infections~     in children requiring a CVC. This study may also determine if antibiotic coated catheters~     will be significantly less likely than non-antibiotic coated catheters to allow bacteria to~     live (colonize) in/on the catheter.~      The use of central venous catheters (CVC) is paramount to the care of critically ill~     children. Thus, in the pediatric intensive care unit (PICU), these catheters are widely used~     in situations when more than peripheral venous access is necessary. This central access~     allows the delivery of fluids, e.g, blood, medications, etc. as well as serves as a means to~     withdraw blood. It has been estimated that more than 250,000 nosocomial bloodstream~     infections occur each year, with 90% of these associated with the use of CVCs. More recently,~     the National Nosocomial Infection Surveillance System (NNIS) reported during 1992-2001~     CVC-associated bloodstream infections (BSI) in ICU settings occurred at rates of 2.9-11.3 BSI~     per 1,000 catheter days. The cost of treating CVC related BSI has been estimated to be in~     excess of $28,000 per catheter. In the adult medical literature, there is strong evidence~     supporting use of antiseptic or antibiotic coated catheters to reduce the cost of~     hospitalization for CVC related infections. Cost-benefit studies have suggested that if the~     baseline incidence of CVC BSI is >0.4 BSI per 1000 catheter days, $59,000 will be saved, 7~     cases of BSI will be avoided, and 1 death prevented for every 300 anti-septic impregnated~     CVCs used.~   "
255779|NCT00202800|"~     Pancreatic cancer is a devastating disease. Previous research shows a correlation between a~     specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs~     combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination~     for locally advanced and metastatic pancreatic cancer.~   "
255780|NCT00202787|"~     The purpose of this study is to determine confirmed objective response rate to combination~     therapy with cetuximab and FOLFOX4 or FOLFOX4 alone in patients with CRC and non-resectable~     hepatic metastases~   "
255781|NCT00202774|"~     The purpose of this study is to determine time to disease progression of combination therapy~     with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous~     infusion (5-FU CI) as first line treatment in advanced or metastatic colorectal cancer~   "
255782|NCT00202761|"~     The purpose of this study is to document that taking part in this program is beneficial for~     the child, its parents and local professionals.~      The study hypothesis are:~      Intensive training will speed up the childs motor, cognitive and social development.~      Intensive habilitation will increase the childs family's empowerment Children having~     participated in this intensive habilitation will speed up their process of development~     further than children in the control group The cooperation between first and second line~     health service is strengthened by participation in the intensive habilitation program The~     professionals in the first line(community)in Norway that participates in this program~     increases their empowerment and motivation~   "
255783|NCT00202748|"~     We know that changing lifestyle can prevent type 2 diabetes. The challenge is how to help~     people changing their lifestyle. We have people in 2 groups: half of them is meeting in grops~     of 10 persons (interventiongroup), the other ones are just visiting their doctor~     (controlgroup).~   "
255784|NCT00202735|"~     Dislocation of the glenohumeral joint is the most common traumatic joint dislocation. The~     usual treatment of first time traumatic anterior dislocation of the shoulder is reduction~     followed by immobilization in a sling for a period of one to three weeks. The incidence of~     recurrence is high and age at the time of primary dislocation is the chief prognostic factor~     in determining the risk of recurrence. There is no agreement according to the effect of~     immobilization,neither to the length of immobilization time. The Bankart lesion with avulsion~     of the inferior-anterior capsulolabral complex is almost invariably present in patients with~     anterior shoulder dislocation. Recent and ongoing studies by Eijii Itoi et al,Akita~     university Japan, gives evidence of the immobilization with the arm held in external rotation~     may reduce the risk of subsequent instability by approximating the Bankart lesion to the neck~     of the glenoid giving a more anatomical healing. We have started a prospective randomized~     study. The patients are assigned to two groups with informed consent. One group are~     immobilized in internal rotation for 3 weeks and the second group are immobilized in external~     rotation for 3 weeks. We will compare the rate of relaxation between the groups. Because age~     is the main prognostic factor we use stratified randomization with two age groups: One group~     of patients aged between 16 and 24 years and one group aged between 25 and 40 years.The time~     of observation after initial treatment will be 2 years with follow up after 4 and 10 years.~     Eleven hospitals and two primary trauma care centers in Norway participate in the study. A~     subgroup of 50 patients are also planned to be examined with CT and MRI.~   "
255785|NCT00202722|"~     Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by~     non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of~     remifentanil used as analgesia during labour. Intravenous patient controlled analgesia~     (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a~     lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate,~     SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was~     recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were~     assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives~     also recorded their impression of the parturients pain. The parturients level of sedation~     were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered~     at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and~     concentration of remifentanil were performed. After delivery, both mother and midwife~     evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were~     sufficient, nausea, vomiting, level of sedation and dizziness.~   "
255786|NCT00202709|"~     The purpose of this study is to find out if Thought Field Therapy has effect on certain~     anxiety disorders; agoraphobia, social phobia, and post traumatic stress disorder (PTSD).~   "
255787|NCT00202696|"~     To determine if nalmefene is safe and effective in smoking cessation.~   "
255788|NCT00202683|"~     This study is is the first step of a full study named CHEMOGENE because it explores the~     genetic determinant of an alteration of the chemoreflex. This reflex determines~     hyperventilation when the pressure of oxygen falls in the blood. This happens when subjects~     travel to high-altitude where oxygen levels diminish in the atmosphere. Subjects with such an~     altered chemoreflex are intolerant to altitude and develop pulmonary or cerebral edema~     associated with a severe headache. In this study we compare subjects tolerant to high~     altitude (8000 meters)to subjects intolerant to altitude. The chemoreflex is measured i.e.~     the hyperventilation associated with hypoxia and all subjects are scanned for the genes~     implicated in the mitochondrial respiratory chain. The idea is that subjects with an impaired~     oxygen sensing will exhibit an altered chemoreflex and will be intolerant to high-altitude.~   "
255789|NCT00202670|"~     The aim of this study is to determine in high risk diabetics if the positive predictive value~     of stress echocardiography is superior to the positive predictive value of stress~     scintigraphy in the diagnosis of coronary stenosis > 50%.~   "
255790|NCT00202657|"~     The purpose of this study is to determine whether patients with Parkinson's disease and~     treated with pergolide have a higher risk of heart valve disease compared to patients with~     Parkinson's disease not treated with pergolide.~   "
255791|NCT00202644|"~     Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to~     be produced. Platelets are small cells carried around in the blood, which help form blood~     clots. When patients have too many platelets, there is a risk of blood clots forming~     unnecessarily and excessive bleeding. The aim of this study is to gain additional information~     on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as~     hydroxycarbamide).~   "
255792|NCT00202631|"~     People with high spinal lesions are at risk of respiratory complications because they have~     partial or complete paralysis of breathing muscles. Previous work has shown that tetraplegic~     lung volumes can be increased by using abdominal FES during expiration. The technique is~     attractive because it is non-invasive, painless in tetraplegia and completely reversible. It~     may provide a treatment for augmenting the patient’s breathing both in the acute presentation~     of spinal injury (when half of cervical injuries require ventilation) and in long term~     management of tetraplegia and high paraplegia. We propose a pilot study in a small group of~     subjects to see if the technique is feasible from both a clinical and engineering viewpoint.~     The aims of the study are: 1)To examine the effects of abdominal FES on lung mechanics and~     gas exchange in tetraplegic subjects. 2)To optimise the stimulation pattern and intensity via~     electronic stimulators and to design a trigger to allow the FES to follow the subject’s own~     breathing cycle automatically.~   "
255793|NCT00202618|"~     The purpose of this trial are to evaluate the reduction of urinary albumin excretion by an~     angiotensin receptor blocker (ARB), valsartan, in comparison with a calcium channel blocker~     (CCB), amlodipine, in Japanese hypertensive patients with type 2 diabetes mellitus and~     microalbuminuria under strict blood pressure control, and to compare the additional effects~     of an ARB or a CCB in combination with angiotensin-converting enzyme (ACE) inhibitor~     treatment.~   "
255794|NCT00202605|"~     The purpose of the study is to evaluate how safe and how well SPD465 works compared to~     placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration~     of clinical benefit.~   "
255795|NCT00202592|"~     The aim of the study is to assess the long-term safety and effects on blood pressure of a~     paediatric formulation of perindopril in hypertensive children~   "
255796|NCT00202579|"~     To evaluate the effects on heart function of ivabradine administered to patients with severe~     chronic heart failure~   "
255797|NCT00202566|"~     To test whether ivabradine when given in combination with atenolol is able to improve the~     exercise tolerance of patients with stable angina pectoris~   "
255798|NCT00202553|"~     The aim of the study is to assess the acceptability, safety and pharmacokinetics and effects~     on blood pressure of a paediatric formulation of perindopril given in hypertensive children~   "
255799|NCT00202540|"~     The purpose of this study is to demonstrate a long term efficacy of S18986 versus placebo on~     episodic memory performance in patients with MCI~   "
255800|NCT00202527|"~     AIMS:To know the effects of the treatment with nasal positive continuous airway pressure~     (CPAP) on systemic blood pressure and the expression of biological mediators, in systemic~     hypertension of recent diagnostic, whose have an apnea-hypopnea index > 15.~      METHODOLOGY: DESIGN: Prospective, multicenter, randomized study, of parallel groups and~     controlled with placebo, in patients diagnosed of systemic hypertension (SH) with an~     apnea-hypopnea index, by conventional polysomnography > 15. A total of 340 patients with~     recently diagnosed of SH and without any pharmacological treatment will be studied. All~     patients will be randomized to receive, alternatively, CPAP treatment with optimal pressure~     titled with a proved system, or Sham-CPAP for 12 weeks.~      MEASUREMENTS: A) Conventional polysomnography at baseline: B) Clinic: sleepiness (ATS, Basic~     Nordic Sleep Questionnaire and Epworth), quality of life (EuroQol); C) 24 hour blood pressure~     monitoring; D) Expression of biological mediators in blood: general determinations,~     endothelial, inflammatory, lipid, renin-angiotensin-aldosterone and adrenergic mediators.~      ANALYSIS. Baseline measurements of all the variables will be compared with the situation at~     six and twelve weeks. We will use the chi square test and the Fisher´s exact test~     (categorical variables), the t test for continous variables and repeated measures ANCOVA for~     the primary objective. The analyses will be done under the criterion of intention to treat~     and for protocol. The variables will be controlled by the compliance with the CPAP..~   "
255801|NCT00202514|"~     The purpose of this study is to test the safety and effectiveness of an extended release form~     of a medication called divalproex sodium (Depakote ER) for the treatment of people with~     alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce~     symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder~     and other mental health disorders. This study will test the hypothesis that divalproex sodium~     will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn~     reduce relapse and craving for alcohol.~   "
255802|NCT00202501|"~     MAIN AIMS: to analyze the efficacy of nasal CPAP treatment in patients with ischemic~     first-ever stroke and Sleep Apnea Syndrome (SAS) in terms of: early neurological outcome,~     functional recovery, quality of life influence, stroke recurrence and survival.~      SECONDARY AIMS: to evaluate the feasibility of the treatment in this type of patients at~     short and long time.~      DESIGN: clinical randomized case-control study.~      PATIENTS: younger than 75 years with a First-Ever stroke with at least one of the following~     criteria: snoring, observed apnea, Hypertension or Ischemic Cardiopathy.~      MEASUREMENTS: protocol to define subtype stroke and parenchymatous and vascular location;~     sleep questionnaire (including Epworth Sleepiness Scale); Respiratory Polysomnography (RPSG).~     If RPSG shows an AHI > 20, with predominant obstructive events, patients will be randomized~     in a CONTROL GROUP (conventional treatment) and a TREATMENT GROUP (with Nasal CPAP). Follow~     up for both groups at 1, 3, 12 and 24 months will include: early neurological outcome, body~     mass index (BMI), blood pressure (BP), functional recovery (Barthel Index/Canadian Scale),~     quality of life (SF36), recurrences, vital status. Nasal CPAP titration will be performed by~     means of an automatic system (Autoset Portable ST). Compliance will be recorded. If a~     negative RPSG is obtained (AHI < 10) (NO SAS GROUP) or with AHI < 20 (mild SAS) the usual~     treatment and the same follow up protocol will be established.~      STATISTICS: the sample size is initially calculated in 10 patients for each group,~     considering this is part of a multicenter study including 8 centers. If no differences are~     found, depending on the statistical power the investigators will consider including more~     patients. The different groups will be compared for the analyzed variables with the~     corresponding tests.~   "
255803|NCT00202488|"~     The purpose of this study is to determine if Helicobacter pylori (H. pylori) gastritis~     results in abnormal iron metabolism in patients with iron deficiency anemia (IDA), and to~     determine if this is due to strain variations in the H. pylori organism.~   "
255949|NCT00200486|"~     The purpose of this study is to study the genetic profile of head and neck tumors and their~     relationship to treatment response and outcome~   "
255804|NCT00202475|"~     The project will determine the advantages of double erythrocytapheresis in the collection of~     preoperative autologous erythrocytes as compared to the standard collections of whole blood.~     The study will assess the total reduction in the number of procedures required to obtain the~     preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus~     classical whole blood collection for these patients will be compared.~   "
255805|NCT00202462|"~     We hypothesize that testosterone replacement will improve mood and quality of life in older~     men with low testosterone and mild depression. Study subjects will receive either~     testosterone gel or a placebo (inactive) gel for 12 weeks. Neither the subject or the~     investigator will know whether they are receiving placebo or testosterone gel. At the end of~     the initial 12 week period, all subjects will receive testosterone gel for 12 more weeks.~     Mood and quality of life measures will be obtained at baseline, at the end of the~     double-blind phase and at the end of the extension phase (when all subjects receive~     testosterone.)~   "
255806|NCT00202449|"~     The purposes of this study are:~        -  to evaluate the efficacy and tolerability of the drug prazosin compared to placebo for~          combat stress-related nightmares, sleep disturbance and overall function in recently~          combat-exposed returnees from Operation Iraqi Freedom (OIF) and Operation Enduring~          Freedom (OEF).~        -  to evaluate the effects of the selective serotonin reuptake inhibitor (SSRI) paroxetine~          on behavioral symptoms and overall function in this population.~   "
255807|NCT00202436|"~     In this project we plan to evaluate the effectiveness of erythrocytapheresis against~     phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction~     in patient burden. Aspects of cost effectiveness will be included in the final analysis.~     Results of the study would allow decision-making based on Evidence Based Medicine on the~     best therapeutic options available for newly-diagnosed as well as existing primary~     hemochromatosis patients.~   "
255808|NCT00202423|"~     This is a 10-week, randomised, double blind, placebo-controlled, crossover trial to~     investigate the effect of Cannabis Based Medicine Extract (Sativex) on patterns of brain~     activation associated with movement in 20 MS patients suffering from lower limb spasticity.~     Spasticity is a common symptom in Multiple Sclerosis (MS), occurring all over the course of~     the disease, particularly in the progressive phase.Physiologically, spasticity and~     hyperreflexia habitually seen in patients with pyramidal syndrome is due to lesions of other~     descending pathways, such as the cortico reticulospinal pathways, which participate in~     voluntary movements.It is now known that an endocannabinoid system acts in humans by at least~     two types of cannabinoids receptors, CB1 and CB2. There is evidence to support the view that~     the psychoactive ingredient in cannabis, delta 9-tetrahydrocannabinol (delta 9-THC), and~     cannabinoids in general, can reduce muscle spasticity in people with MS. Aim of the study~     will be to evaluate the effect of Sativex on: (i) patterns of brain activation associated~     with movement (fMRI) in MS patients suffering from spasticity; (ii) changes in level of~     spasticity (H-reflex); (iii) changes in intracortical excitability and on synaptic~     intracortical network of the motor areas (double shock TMS).~   "
255809|NCT00202410|"~     The frequency of auto-immune diseases (including multiple sclerosis) is increasing in~     industrialised countries.~      According to an hypothesis which is receiving a wide international credit, this may be due to~     the fact that the populations of these countries are increasingly less exposed to microbes~     further to the improvement of hygienic conditions and to the use of antibiotics.~      If exposure to microbes is lacking, also their regulatory function is missed with a~     consequent possible onset of auto-immune symptoms.~      For this reason, it is deemed that by exposing the immune system of a patient to an ancient~     microbe, being complex and important in man evolution, like the Tuberculosis Mycobacterium,~     it is possible to rebalance the immune system.~   "
255810|NCT00202397|"~     Cerebellar disorders are often disabling and symptomatic therapies are limited to few options~     that are partially effective. It seems therefore appropriate to search for additional~     approaches.~      Purkinje cells are the sole output of the cerebellar cortex: they project inhibitory signals~     to the deep cerebellar nuclei (DCN), which have a critical role in cerebellar function and~     motor performance. DCN neurons fire spontaneously in the absence of synaptic input from~     Purkinje neurons and modulation of the DCN response by Purkinje input is believed to be~     responsible for coordination of movement. Recent evidences support the notion that an~     increase in DCN excitability may be an important step in the development of cerebellar ataxia~     and point to the underlying molecular mechanisms: the inhibition of small-conductance~     calcium-activated potassium (SK) channels, that causes an increase of the firing frequency in~     DCN, correlates with cerebellar ataxia.~      The rationale of the present project is that SK channel openers, such as riluzole, may have a~     beneficial effect on cerebellar ataxia.~      The researchers propose to perform a pilot study investigating safety and efficacy of~     riluzole, an approved treatment for amyotrophic lateral sclerosis, as a symptomatic approach~     in patients with chronic cerebellar ataxia.~   "
255811|NCT00202384|"~     Clinical and experimental evidences suggest that there is a variability in therapeutic~     response to immunomodulating therapies in Multiple Sclerosis patients.~      Microarrays is a technology that permits to monitor the expression levels of thousands of~     genes at a time.~      The specific aim of this study is to identify predictive factors of therapeutic response in~     MS patients treated with high-dose Interferon-Beta.~   "
255812|NCT00202371|"~     The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion~     trigger: 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger: 9.6~     gr/dl) on physical fatigue.~   "
255813|NCT00202358|"~     Studies have shown that beta-blockers such as atenolol when given in the perioperative period~     reduce morbidity and mortality. One study showed that atenolol given just during the surgery~     period, seemed to improve outcomes up to 2 years later. This is hard to explain since~     beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart~     rate and blood pressure.~      This study is designed to find out if perioperative atenolol might exert its long term~     effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood~     pressure. It is known that inflammation increases after surgery as part of the healing~     process. However, it is also becoming clear that low-grade chronic inflammation can also lead~     to long term adverse effects.~   "
255950|NCT00200473|"~     A study to determine the safety, efficacy and superiority of nebivolol to placebo for the~     treatment of elevated blood pressure in patients with mild to moderate hypertension.~   "
255814|NCT00202345|"~     One of the complications of late stage kidney disease is the development of a low red blood~     cell count (anaemia/low haemoglobin concentration). The Australian Commonwealth government~     limits funding of medications (called erythropoietic stimulating agents) to those patients~     who have already developed anaemia.~      There is evidence supporting the beneficial effects of maintaining a higher haemoglobin in~     these patients. Higher haemoglobin can delay the onset of dialysis and reduce the development~     of heart enlargement. However, the administration of erythropoietic stimulating agents is not~     without risk, including a high financial burden, worsening of high blood pressure and a rare~     complication called pure red cell aplasia.~      Previous studies have shown that patients with chronic kidney disease require additional iron~     to maintain the production of red blood cells. Thus it would be timely to determine if the~     administration of iron sucrose to these patients can maintain a near normal haemoglobin~     concentration, without the need to start an erythropoietic stimulating agent and possibly~     delaying dialysis.~      Study Hypothesis: That administration of iron sucrose is superior to standard care in the~     prevention of anaemia in patients with stage 3 /4 kidney disease.~   "
255815|NCT00202332|"~     Comparison of clinical outcomes in patients undergoing coronary bypass surgery using the~     heart/lung machine as opposed to using off-pump techniques.~   "
255816|NCT00202319|"~     Sedation is an important treatment when caring for the critically ill patient on a~     respirator. Adequate sedation has been found to reduce stress, promote relaxation, induce~     amnesia, improve the tolerance of the respirator, and generally assist nursing care. However~     all sedation produces side effects for the patients. The aim of this study is to measure the~     effectiveness of two approaches to sedation management in an Australian Intensive Care unit.~   "
255817|NCT00202306|"~     This study investigates the neuroprotective properties of low-dose lithium in young~     individuals at ultra-high risk of developping a first psychotic episode. Fourty individuals~     having some symptoms of an emerging psychotic disorders (without meeting the threshold for a~     full-blown mental illness) will be treated with a low dose of lithium (about a third of the~     dose that is usually used to treat acute mania). We will assess the progression of the~     conditions of these individuals on a montly bases for a year. We will do behavioural,~     cognitive and imaging assessments prior start of the treatment, after three months and one~     year. We hope to demonstrate that low dose lithium will stop or even reverse the progression~     of disease. We expect that behavioral, cognitive and in vivo brain imaging parameters in~     those individuals treated with low dose lithium improve, compared to the monitoring group.~   "
255818|NCT00202293|"~     Aim: In a population of first episode manic patients with psychotic features, we want to~     compare the side effect profile, the degree of adherence and the subjective well being, as~     well as the efficacy of two treatments: The standard treatment currently applied (lithium +~     chlorpromazine) and an alternative treatment more recently introduced (lithium + olanzapine).~     In addition, we want to study retrospectively the development of bipolar disorder and study~     prospectively the 6 and 12-month outcome of a cohort of patients presenting a first manic~     episode with psychotic features.~      Research Background: While the efficacy of lithium in the treatment of acute mania has been~     established by numerous studies, it is also known that up to 50% of the patients fail to~     respond when it is prescribed alone. It is therefore common practice to complement the~     treatment, most commonly with antipsychotics and benzodiazepines. It has been suggested that~     antipsychotic agents are faster acting and are superior in controlling hyperactivity compared~     to lithium, whereas mood stabilisation is better achieved by lithium, Typical antipsychotics,~     such as chlorpromazine, may therefore be useful as adjunctive medication to mood stabilisers,~     especially within the first few weeks of treatment of acute mania, and for patients~     exhibiting psychotic symptoms or hyperactivity. They however can induce side effects~     (somnolence, dizziness, dry mouth, extrapyramidal side effects such as rigidity of the~     muscles, and possibly tardive dyskinesia (involuntary movements or contraction of muscles),~     as well as akathysia (sense of restlessness). They finally have been suspected to contribute~     to the occurrence of post-manic depression. Recent publications in chronic populations have~     shown that atypical antipsychotics, such as olanzapine, are also an effective adjunctive~     treatment. Olanzapine has the important advantage to induce a very low incidence of~     extrapyramidal side effects, including tardive dyskinesia. It can however induce somnolence,~     dizziness, dry mouth, and rather commonly weight gain. Moreover, some authors have reported~     that olanzapine might induce mania. Both treatments appear then to have positive effects as~     well as undesirable side effects. Our project is to compare them. The literature concerning~     first episode mania is sparse, particularly in the domain of pharmacotherapy. One~     retrospective study showed that 77% of the patients received antipsychotics at discharge and~     25% at 6 months follow-up. No comparison has however been made between typical and atypical~     antipsychotics, and there are no specific treatment guidelines of first episode mania with~     psychotic features.~      Project Summary: The hypothesis is that olanzapine and chlorpromazine will have a comparable~     efficacy as adjunctive treatment of the acute manic episode with psychotic features. We~     however think olanzapine will induce less side effects and will be better accepted by the~     patients, and therefore that the adherence to the treatment will be better than with~     chlorpromazine. We finally think the subjective sense of well being will be greater with~     olanzapine than with chlorpromazine.We will recruit 75 patients at the time of their first~     admission for mania with psychotic features at EPPIC. After signature of the informed~     consent, we will perform a baseline assessment first to confirm the diagnosis, and second to~     evaluate the level of psychopathology. The patients will then be randomly selected to receive~     either a treatment of lithium and olanzapine or a treatment of lithium and chlorpromazine. By~     the end of the study there will be 37 patients in each group.The patients will go through a~     baseline assessment including physical examination and usual laboratory investigation to~     exclude any physical illness. They will also go through a one-hour assessment of~     psychopathology. Between day 2 and 3 they will go through 2 hours of interview to reassess~     diagnosis and personal history. They will thereafter be assessed weekly for eight weeks on~     various dimensions: evolution of the intensity of the symptoms, appearance of depressive~     symptoms, occurrence of side effects and degree of adherence to the treatment, in an 1-hour~     interview. Subjective well being and quality of life will re evaluated at week 4 and 8,~     adding 45 minutes to the duration of the interview. This is a flexible dose, open trial,~     which means the doctor in charge of the patient will know which medication is being~     prescribed, and that he will be allowed to adapt the dosage according to what he feels~     necessary. This research project will allow us to organise a more specialised clinic for the~     care of first episode manic patients. We will take this opportunity to study carefully the~     months preceding the appearance of the first episode in order to try to reconstruct the~     prodrome of bipolar disorders. We will also, in an extension phase of the study, look at the~     long term outcome (at 6 and 12 months) of a first episode of mania.~   "
255819|NCT00202280|"~     The purpose of this study is to determine whether Vitamin B12,B6 and Folic Acid are effective~     with antipsychotic medication in the treatment of First Episode Psychosis.The B-complex~     Vitamins' homocysteine lowering properties may have an effect on cognition and symptoms. We~     are examining changes in symptoms and cognition over a 3 month period.~   "
255820|NCT00202267|"~     Leg ulcers are emotionally distressing and painful, and often require months or years to~     heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a~     common, complex, and costly condition, managed primarily through community home care~     services. Indeed, leg ulcers are the most frequently seen and treated chronic wound. There is~     consensus in recent international, evidence-based practice guidelines that graduated,~     multi-layer compression is the most effective treatment, and greatly reduces healing time.~     High compression is more effective than low compression. However, there is no clear evidence~     as to which high compression technology is the most effective in promoting healing, the most~     acceptable to patients, or the most cost-effective to the health care system. This study is~     designed to answer these questions through a randomized trial conducted in the community,~     where most leg ulcer care currently takes place. Issues such as effectiveness in healing,~     quality of life, physical discomfort, personal preference, cost to the system and to the~     individual will be taken into consideration in evaluating two most commonly used types of~     compression bandaging.~   "
255821|NCT00202254|"~     The effects of routine rehabilitation in MS patients versus no rehabilitation.~   "
255822|NCT00202241|"~     The main aim of the study is to investigate the combined effects of using anabolic steroids~     and protease inhibitors on fat metabolism and body composition of People Living with~     HIV/AIDS.~      We are seeking to answer the following questions:~      1) Are there any significant differences in serum blood lipids, lipodystrophy, in persons~     with HIV taking antiretroviral therapies and anabolic steroids versus antiretroviral~     therapies alone?~   "
255823|NCT00202228|"~     Lactic acidosis is a potentially life-threatening disease associated with the treatment of~     chronic HIV infection. Although acidosis is rare, hyperlactatemia is common and may have long~     term consequences yet to be recognized. Lactic acidosis is a manifestation of mitochondrial~     toxicity; consequences which have yet to be fully recognized and understood. In this study,~     we propose to look at lactate clearance and production by two methods, in four treatment~     groups, including HIV positive subjects on highly active antiretroviral therapy (HAART)~     treatment regimes and without HAART regimes, with liver steatosis and without, and compared~     with HIV negative controls. Supplementation with cofactors thiamine, niacin and L-carnitine,~     which may have a positive effect on lactate metabolism by facilitating mitochondrial~     function, will be studied as well.~   "
255824|NCT00202215|"~     This is a study to determine if the approach taken to treat patients in the Chrysalis Day~     Hospital Program will favourably effect their health status as assessed by Body Mass Index~     (BMI)~   "
255825|NCT00202202|"~     Can we improve our community partners satisfaction with a change in how psychiatric~     consultations are delivered to their clients by our psychiatrist? This survey of users of the~     service will compare the level of satisfaction before(retrospectively) to after the way the~     service is provided is changed.~   "
255836|NCT00202046|"~     The purpose of this study evaluate which factors play a role in lymphedema development among~     women who have had axillary surgery for breast cancer. Potential risk factors for women who~     have developed lymphedema will be compared to risk factors among women who have not developed~     lymphedema after breast cancer surgery.~   "
255837|NCT00202033|"~     To determine if the frequency of blood glucose testing in patients with type 2 diabetes who~     are being treated with diet and exercise alone or diet and exercise plus oral agents will~     impact the HbA1c level.~   "
255826|NCT00202189|"~     Human and animal studies have shown that inhaled corticosteroids (ICS) decrease airway blood~     flow . This effect is immediate (within 30 minutes), transient (lasting 90 minutes), and in~     animal studies independent of gene expression. In COPD patients, decrease in bronchial blood~     flow may also decrease mucosal edema, airway resistance and improve small airway function. If~     such an effect exists, then we should be able to measure improvements in airway conductance~     and reduce lung hyperinflation, which would have salutary effects on dyspnea and exercise~     endurance.~      To our knowledge, no study has examined the immediate effect of ICS on small airway function~     in COPD. The purpose of this study is to examine the effects of nebulized Pulmicort on small~     airway function (spirometry, plethysmographic lung volumes, airways resistance, closing~     volume, partial flow-volume loop analysis) and exercise endurance in patients with moderate~     to severe COPD.~      HYPOTHESIS~        1. Nebulized ICS will immediately improve airway function compared with placebo (nebulized~          saline).~        2. Enhanced lung emptying and reduced operating lung volumes during rest and exercise~          following ICS therapy will translate acutely into clinically important reductions in~          exertional dyspnea and improvements in exercise endurance.~   "
255827|NCT00202176|"~     In people with mild COPD, the ability to exhale air from the lungs is partly limited because~     of narrowing and collapse of the airways. This results in the trapping of air within the~     lungs and over-distention of the lungs and chest (lung hyperinflation).~      Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort~     (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or~     breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing~     as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can~     be taken orally, through injection or through inhalation and begin to act almost immediately~     but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the~     effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients~     with mild COPD.~   "
255828|NCT00202163|"~     Androgen deficiency in the aging male is poorly understood. The objective of this study will~     be to determine the role of testosterone and DHEA in enhancing sexual interest and sexual~     performance.~   "
255829|NCT00202150|"~     Patients living with advanced chronic diseases (ACD), such as congestive heart failure (CHF)~     and chronic obstructive lung disease (COPD) present substantial care and economic challenges~     for the health care system due to frequent emergency room visits and acute care~     hospitalizations. Morbidity and mortality is high in these complex populations, and patient~     quality of life is often compromised.~      Care of patients with ACD occurs across health care sectors, by providers in the acute,~     primary and community settings. Despite recent efforts to enhance the care of patients with~     ACD, through multidisciplinary disease management programs, variations and gaps exist along~     the continuum of care. The available evidence suggests that there are opportunities to~     optimize the primary care of patients with ACD. We are proposing to build upon the current~     evidence and guidelines for disease management programs, our existing specialized resources,~     our existing primary care practices, and develop and test a model of care that is primary~     care based, sensitive to the unique demands and characteristics of different primary~     practices. Our goal is to design linkages and care strategies of relevance and importance to~     the primary care providers who care for patients with advanced COPD and CHF.~      This demonstration project is a randomized controlled clinical trial of the RoadMAP program~     (intervention) delivered by a Primary Care Nurse Specialist (PCNS) compared to usual care~     (control group). The primary outcomes will be degree of adherence to clinical practice~     guidelines. Secondary outcomes will be patient satisfaction, quality of life, use of~     community-based services, number of emergency room visits, and number of hospitalizations.~   "
255830|NCT00202137|"~     Hypertension is a common problem in Canada with a prevalence of about 15%. The goal of~     hypertension therapy should be to maximize blood pressure control. Home blood pressure~     monitoring (HBPM) devices are available and many patients are using them. The role that~     self-monitoring of blood pressure can play in optimizing blood pressure control is unclear.~     We hope to clarify the role of home blood pressure monitoring in the treatment of~     hypertension and explore how it may affect patient and physician behaviours related to blood~     pressure management. This study will compare a group of hypertensive patients who use HBPM~     with those who do not use these devices. The intervention (HBPM) group will measure their~     blood pressure at home a minimum of once weekly and will report these measurements to their~     family doctor at each visit. The control group will receive usual care as delivered by their~     family doctor. Outcomes of blood pressure control will be measured over a 12 month period.~     Outcomes will be determined primarily by 24 hour ambulatory blood pressure monitoring and by~     reviewing data in patient's charts located in family physicians office. Fifty family~     physicians from the Kingston area have agreed to participate.~   "
255831|NCT00202124|"~     The purpose of this study is to determine whether tryptophan is effective in the treatment of~     mild to moderate Alzheimer's Disease (AD).~   "
255832|NCT00202111|"~     The purpose of this study is to compare the short and long term outcomes of people who have~     colon cancers removed either by laparotomy (a large cut in the abdominal wall) or by a~     laparoscopic assisted approach (keyhole surgery). This study involves 37 credentialled~     surgeons in 20 approved hospitals across Australasia and during the recruitment period (Jan~     1998 to March 2005) 601 patients were recruited into the ALCCaS Trial.~   "
255833|NCT00202098|"~     The purpose of this study is to determine the effects of variable ventilation on respiratory~     system of patients affected by acute respiratory distress syndrome.~   "
255834|NCT00202072|"~     The purpose of this study is to determine whether mucin is increased during pulmonay~     exacerbations in adult patients with cystic fibrosis (CF).~   "
255835|NCT00202059|"~     The purpose of this study is to evaluate the effect of zoledronic acid and physical activity~     on preventing bone loss in women aged 40 - 55 who are receiving chemotherapy for breast~     cancer. The primary objective is to compare the percent change in the lumbar spine bone~     mineral density (BMD) from baseline to 12 months for women who are randomized to either:~     Group A) intravenous zoledronic acid, oral calcium carbonate, and vitamin D, or Group B) a~     prescribed physical activity program, oral calcium carbonate and vitamin D.~   "
255859|NCT00201747|"~     To determine the most efficacious of two combination regimens of sequential CPT-11 and MMC in~     patients with advanced and previously untreated esophageal and GE junction adenocarcinomas.~   "
255838|NCT00202020|"~     The study design is subject to relevant SFDA regulations about clinical trials. This~     indication was approved in Japan in 2003.~      From the end of May 2004 to the end of Dec. 2004, 720 patients with previous cerebral~     infarction(see the inclusion criteria) were enrolled in to the study and received one of the~     two treatment regimens, Cilostazol or Aspirin, the ratio of patient number of each group is~     1:1. For each patient, the chance of entering either of these two groups is the same. The~     treatment will continue till the end of 2005. During the treatment period, patients will be~     observed concerning some certain events, mainly reoccurrence of stroke. If the patient~     experiences reoccurrence of stroke, or other event that the doctors think it is not~     appropriate to continue the study medication, this patient would stop the treatment. Patients~     were also required to take MRI head scan before entering the study and on completion of the~     treatment.~   "
255839|NCT00202007|"~     This study design is subject to relevant SFDA regulations about clinical trials. Patients~     will be screened for inclusion into the study at the initial visit(240 patients to be~     recruited) and then undergo a minimum of 3-7 day’s placebo washout period(placebo wash out is~     to eliminate the effect of prior antipsychotic medication with tablets without any active~     ingredients)(patients without prior antipsychotic medication are exempt from the washout~     phase). After screening and washout period, eligible patients will be randomly assigned to~     the two treatment group, Aripiprazole or Risperidone, for 6 week’s treatment. Patients will~     be hospitalized for the entire duration of the study. Patients’ condition will be assessed~     weekly.~   "
255840|NCT00201994|"~     This study's purpose is to determine whether tolvaptan can safely and effectively return the~     body's balance of sodium and water toward normal, and to characterize and quantify the~     potential clinical benefits of this treatment.~   "
255841|NCT00201981|"~     The purpose of this study is to determine the potential safety and effectiveness of~     rebamipide eye drops, an investigational eye drop being developed for the treatment of~     keratoconjunctivitis sicca (dry eye).~   "
255842|NCT00201968|"~     The purpose of this study is to evaluate whether an aerobic and resistance training program~     or a functional electrical stimulation-assisted Walking program is more effective for~     reducing health complications related to spinal cord injury, for example, the occurrence of~     bladder infections, pressure sores and/or frequency of spasms. It is hypothesized that the~     functional electrical stimulation-assisted walking will have a greater impact on secondary~     complications than the aerobic and resistance training program.~   "
255843|NCT00201955|"~     The purpose of this study is to determine the potential safety and effectiveness of~     rebamipide eye drops, an investigational eye drop being developed for the treatment of~     keratoconjunctivitis sicca (dry eye).~   "
255844|NCT00201942|"~     The overall goal of this study is to determine how FDG-PET can be incorporated into the~     assessment of the axilla in the staging and treatment of women with early stage breast~     cancer.~      A multicentre, prospective, diagnostic accuracy study will be conducted evaluating the~     ability of positronic emission tomography using fluorodeoxyglucose (FDG-PET) to detect the~     presence or absence of axillary lymph node metastases in newly diagnosed breast cancer~     patients with no clinical evidence of spread of disease beyond the breast.~   "
255845|NCT00201929|"~     To enhance information transfer and decision making for women with breast cancer.~   "
255846|NCT00201916|"~     To improve the management of patients with early stage prostate cancer.~   "
255847|NCT00201903|"~     To explore the relationship between tissue factor levels, tumour progression, activation of~     blood coagulation and venous thromboembolism with malignant glioma~   "
255848|NCT00201890|"~     The purpose of this study is to evaluate the efficacy, safety and impact on quality of life~     of decongestive lymphatic therapy (DLT) in women who have completed treatment for breast~     cancer and present with lymphedema.~      This is a multicentre trial enrolling 100 patients randomized to receive conservative care~     for arm lymphedema (Canadian Guidelines) with or without decongestive lymphatic therapy~     performed by a professional who has received training and certification in the technique of~     lymphatic draining massage.~      Duration: One year after the last patient is randomized.~   "
255849|NCT00201877|"~     This study will determine the overall response rate and toxicity of rituximab and Velcade in~     combination in patients with relapsed or refractory mantle cell non-Hodgkin's lymphoma.~   "
255850|NCT00201864|"~     The purpose of this trial is to evaluate time to progression in women with hormone responsive~     advanced breast cancer treated with a combination of exemestane and fulvestrant.~   "
255851|NCT00201851|"~     This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different~     times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510~     premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at~     hospitals in Philippines, Vietnam, and Morocco.~   "
255852|NCT00201838|"~     The aims of this protocol are:~        1. To study the safety and tolerability of the combination of etanercept and gemcitabine in~          patients with advanced pancreatic cancer:~        2. To estimate the anti-tumor effect as measured by the proportion of patients free of~          disease-progression at six months after treatment initiation.~   "
255853|NCT00201825|"~     This study will determine the objective response rate in chemotherapy naive non-small cell~     lung cancer patients with advanced disease.~   "
255854|NCT00201812|"~     To determine the safety and efficacy of the combination of Etanercept and Docetaxel in~     patients with advanced solid tumors for which there is no standard treatment.~   "
255855|NCT00201799|"~     This study will evaluate the efficacy of infliximab in reducing the incidence of grade II-IV~     acute graft versus host disease by day +100 post-transplant in patients undergoing allogeneic~     hematopoietic stem cell transplant.~   "
255856|NCT00201786|"~     This study will evaluate the response rate to treatment with pentostatin in~     steroid-refractory acute graft versus host disease.~   "
255857|NCT00201773|"~     To test whether the addition of the COX-2 inhibitor, celecoxib, will decrease the gene~     expression of CYP19 in breast cancers collected from postmenopausal women that receive~     neoadjuvant exemestane.~   "
255858|NCT00201760|"~     This study determines the proportion of metastatic breast cancer patients progression free~     after 6 months when treated with gemcitabine/ cisplatin/ trastuzumab or gemcitabine/~     trastuzumab.~   "
255861|NCT00201721|"~     This study aims to assess the rate of complete and overall response using rituximab and~     pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this~     regimen, and to determine the overall and progression-free survival in CLL patients~   "
255862|NCT00201708|"~     This study will determine if docetaxel will be administered before or after~     doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a~     subsequent phase III trial.~   "
255863|NCT00201695|"~     This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic~     trioxide to achieve an overall response rate of greater than 60%.~   "
255864|NCT00201682|"~     This is a phase I/II study of the combination of etanercept and rituximab in patients with~     chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This combination is~     proposed to improve the efficacy and diminish the toxicity of this the~   "
255865|NCT00201669|"~     This study will determine the efficacy of clofarabine as measured by response rate in~     patients with aggressive non-Hodgkin's lymphoma~   "
255866|NCT00201656|"~     The purpose of this study is to determine whether retention of cervical cerclage after PPROM~     improves latency (without a significant increase in chorioamnionitis) and lessens neonatal~     morbidity.~   "
255867|NCT00201643|"~     The hypothesis is that administration of two courses of antenatal corticosteroids, compared~     to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in~     patients delivering prior to 34 weeks' gestation.~   "
255868|NCT00201630|"~     To asess the efficacy of Uroxatrol, an alpha blocker in men undergoing prostate brachytherapy~     to treat prostate cancer, and whether the use of Uroxatrol in advance of the brachytherapy is~     better or not than starting it on the day of surgery.~   "
255869|NCT00201617|"~     The purpose of this 3-year prospective investigation is to examine the short-term and~     long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single~     sided deafness~   "
255870|NCT00201591|"~     The study investigated if aerobic endurance exercise of different intensity has different~     impact on the physical capacity and myocardial function in patients with coronary artery~     disease. Patients with stable CAD trained for 10 weeks, and oxygen consumption and myocardial~     function were measured before and after this period. Patients were randomly assigned to each~     exercise group.~   "
255871|NCT00201578|"~     The use of traditional Chinese herbal medicine and various forms of alternative medicine to~     maintain health among the Chinese ethnic group has had a long history and has been deeply~     rooted in the Chinese way of living for centuries. It has been a general belief that these~     therapies consist of “natural” substances and are less toxic than their western synthetic~     drug counterparts. However, recent reports of side effects of systemic traditional Chinese~     medicine, including hypersensitivity, hepatotoxicity, neurotoxicity, cardiovascular toxicity,~     renal failure, and contact dermatitis, have been increasing.~      Since there is a high prevalence in the usage of traditional Chinese herbal medicine in~     Taiwan, this study examines the frequency of patients using herbal medicine whose initial~     diagnosis in the emergency department (ED) is acute non viral hepatitis. We, the researchers~     at National Taiwan University Hospital, then correlate if the cause of hepatitis is related~     to the use of these herbal drugs by taking a detailed history of medication or herbs used and~     by verifying the contents by chemical analysis of the “medications” used. To our knowledge,~     this is the first study in examining the relationship between non viral hepatitis and the use~     of herbal drugs prior to arriving at the ED. We expect to prove adverse effects of these~     substances, especially hepatitis, is the cause for requiring emergency care.~      Our study design is a prospective, density sampling case control study in which one hundred~     patients with non viral hepatitis will be recruited as our case. We use a questionnaire~     designed by the investigator in the survey of demographic background, education, and income~     status of the cases, as well as the frequency of use of the drug, total dosage used, where~     the drug was purchased, what the drug is used for, and whether they know of any adverse~     effect that the drug might have. If they had taken the drug within three months prior to this~     emergency visit, then they are asked to bring the drug in for examination. Examination of the~     drug includes the use of high performance liquid chromatography (HPLC) and if necessary,~     inductively coupled plasma mass spectrometry (ICP mass). In contrast, our control group~     consists of subjects that are admitted to the ED due to trauma or fracture. For each case,~     they are matched with two subjects in the control group in both gender and age. They should~     also arrive within two days after the arrival of the case. All cases and controls are~     screened for viral hepatitis and serology must be negative before entering the study. The~     questionnaire is given to both groups. If more than one control is eligible to enter the~     study, then the control is chosen by a random draw in a hat. After this use of density~     sampling, we collect the data and logistic regression is used for analysis.~   "
255872|NCT00201565|"~     Arterial pulse wave velocity (PWV) is strongly correlated with atherosclerosis, and the PWV~     of carotid or femoral artery could predict the severity of arterial atherosclerosis. Because~     the measurement of PWV is noninvasive, it would serve as a good clinical and screen marker to~     evaluate the extent of atherosclerosis. The study uses self-made PWV measurement device to~     investigate the correlation of the PWV in the high cardiovascular risk population, and~     compare it with normal population.~   "
255873|NCT00201552|"~     Statin could decrease AF burden~   "
255874|NCT00201539|"~     This is a double -blind randomized crossover study to provide evidence for the expert advice~     based recommendation of the Expert Working Group of the European Association for Palliative~     Care (EAPC) that patients during treatment with IR morphine are given a double dose at~     bed-time that replaces the next 4-hourly dose during night. In addition to the primary,~     blinded clinical part of the study, an experimental part is also included. This part consists~     of two open study days were morphine IR is given in the same fashion as the clinical study.~     The aim is to study whether pharmacokinetic data supports the clinical data.~      The use of a double-bedtime IR morphine dose is equal to regularly scheduled IR morphine~     every 4-hour during night in respect to pain relief during night for patients with pain~     caused by malignant disease~   "
255875|NCT00201526|"~     To describe the broad spectrum of Bipolar Disorder patients admitted to out-patient and~     in-patient psychiatric departments in Norway. Include all admitted Bipolar patients both with~     and without co-morbid disorders.~   "
255876|NCT00201513|"~     Muscular stability is essential to the spinal column to avoid harmful strain and injury to~     its structures. Sudden postural disturbances impose reactive internal forces through the~     spine. If the muscles do not react before the internal reactive forces propagate through the~     spine, there is a short fraction of time where the spinal column may lack sufficient muscular~     support. Studies have shown that in patients with low back pain deep abdominal and back~     muscle have a delayed response to reactive forces. The purpose of this study is to verify~     these findings and to investigate whether tailored interventions can improve the reaction~     time in stabilizing muscle around the lower spinal column i patients with subacute and~     chronic low back pain.~   "
255951|NCT00200460|"~     The purpose of this study is to evaluate the effects of various doses of nebivolol in~     patients with mild to moderate hypertension.~   "
255877|NCT00201500|"~     The purpose of this study is (1) to examine whether the left ventricular function is impaired~     in women with preeclampsia relative to healthy pregnant controls, (2) to examine whether the~     endothelial function is impaired in women with preeclampsia relative to healthy pregnant~     controls, and (3) to examine whether there is a post partum impairment in left ventricular~     and endothelial function.~   "
255878|NCT00201487|"~     Choline has been found in increased concentration in breast cancer patients. Hypothesis: The~     choline signal as observed by MRS is sensitive to treatment, and a positive response to~     treatment will give a reduction in choline concentration.~      The purpose of this study is to establish methods for quantification of choline in breast~     cancer by MRS~   "
255879|NCT00201474|"~     The purpose of the study is to investigate whether patients with brief depressive periods~     together with other fluctuating psychiatric symptoms, have this condition due to epilepsy or~     an other organic brain disorder.~   "
255880|NCT00201461|"~     The primary objective of the study is to determine whether the STARFlex® septal closure~     system will safely and effectively prevent a recurrent embolic stroke/transient ischemic~     attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the~     STARFlex® device compared to best medical therapy.~   "
255881|NCT00201448|"~     The purpose of this study is to evaluate the safety and effectiveness of a vaccine given to~     women ages 18-45 to prevent cytomegalovirus (CMV), which they may catch from their children~     who attend daycare centers. Cytomegalovirus does not usually cause serious illness in adults~     and children. However, CMV can be a cause of deafness and mental retardation in a child born~     from a mother who has the infection during pregnancy. Women in the study will be given either~     cytomegalovirus or Hepatitis A vaccine. A blood sample will be taken before the vaccination~     is given. After vaccination, urine, saliva, and blood will be collected every 1-6 months for~     up to 3 years. Information regarding any reaction to the vaccination will be collected. All~     family members will be asked to provide urine and saliva to test for CMV every few months for~     up to 3 years. All children born to women who have been vaccinated will be tested for CMV~     infection. 180 women who are not infected with CMV will be vaccinated.~   "
255882|NCT00201435|"~     We want to compare Taxol given weekly with Taxotere given every 3 week both in comination~     with Xeloda. We are going to compare time to treatment failure and quality of life.~   "
255883|NCT00201422|"~     To evaluate the therapeutic effectiveness of H. pylori eradication in stage IE & IIE-1~     primary low-grade B cell lymphoma of MALT of the stomach~   "
255884|NCT00201409|"~     This study will test the hypothesis that administration of granulocyte-macrophage colony~     stimulating factor (GM-CSF) to patients with acute lung injury/acute respiratory distress~     syndrome (ALI/ARDS) will improve the clinical course and outcome by shortening the duration~     of mechanical ventilation for these patients.~   "
255885|NCT00201396|"~     Investigate the effect of induction MEPFL chemotherapy followed by concurrent~     chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with~     advanced NPC.~   "
255886|NCT00201383|"~     The purpose of this study is to confirm the value of concurrent chemoradiotherapy in~     improving the locoregional control and survival of patients with resected locally advanced~     HNSCC, a phase III randomized study is proposed. The population studied in this trial is~     limited to patients of oral cavity cancer; this could reduce the confounding factor of~     varying prognosis in patients of different primary sites of HNSCC.~   "
255887|NCT00201370|"~     The aims of this study are:~        1. Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled~          from medical centers in Taiwan and analysis of the related epidemiological factors.~        2. Providing a better understanding of the natural history of HPV infection with its~          correlation with pathologic changes through a longitudinal follow-up of LSIL cases.~   "
255888|NCT00201357|"~     Trial objectives: The primary objective is to determine the proportion of patients who have~     50% decrease in PSA maintained for at least 4 weeks, in advanced hormone-refractory prostate~     cancer (HRPC) patients who receive thalidomide (100 mg BID). Secondary objectives include the~     objective tumor response rate for measurable lesions, the median duration of tumor response,~     median time to disease progression and assessments of clinical benefits, quality of life, and~     safety profile.~   "
255889|NCT00201344|"~     -  To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs~          radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of~          the study includes : overall survival, relapse free survival, distant metastasis and~          local-regional control rates.~        -  To evaluate the toxicities of the two treatment methods.~   "
255890|NCT00201331|"~     Based on the astonishing high response rate in metastatic colorectal cancer in weekly high~     dose 5-FU and leucovorin, we will conduct a clinical trial to clarify the activity of this~     regimen in the adjuvant setting. The regimen of 5-FU and high dose leucovorin administered as~     the schedule of INT-0089 will be chosen as the controlled arm which was proven as effective~     as standard 5-FU plus levamisole regimen with short duration of treatment.21 In this study,~     continuous infusion of 5-FU (HDFL, Arm B) and bolus injection of 5-FU (Arm A) will be~     administered to the high risk colon cancer(N2 disease) patients. The role of TS level and~     inhibition of TS as a predictor of adjuvant chemotherapy with 5-FU based treatment will be~     clearly defined prospectively.~   "
255891|NCT00201318|"~     * AIMS OF THE STUDY (STUDY OBJECTIVES)~        1. To test the effect of daily lamivudine (100 mg) in reducing the risk of HBV reactivation~          and hepatitis development in HBsAg (+) NHL patients.~        2. To test the efficacy of daily lamivudine in preventing and treating hepatitis B~          reactivation and in circumventing hepatic failure and death.~        3. To test whether lamivudine can improve the overall outcome of NHL patients who are HBV~          carriers.~      (Study end-points: The major end-point: hepatitis B reactivation in NHL patients---defined by~     higher than 10-fold increase of serum HBV DNA level and/or reappearance of HBeAg in the serum~     during and within 6 months after chemotherapy. The minor end-point I : events of hepatic~     failure and death---defined by jaundice with hepatic encephalopathy. The minor end-point II:~     the response rate and survival rate in HBsAg-positive NHL patients receiving lamivudine~     prophylaxis and treatment.)~   "
256024|NCT00199511|"~     The purpose of this study is to evaluate the effect of Hypertonic Saline 7.5% vs Mannitol 20%~     on brain bulk (using a 4 point scale), intracranial pressure (subdural catheter)and the~     changes on serum and urinary Na, K and Osmolarity during elective craniotomy for brain tumor~     resection.~   "
255892|NCT00201305|"~     This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin~     infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. The~     primary endpoint is patients' response and the secondary endpoints are chemotherapy-related~     toxicity, time to disease progression and overall survival. .~   "
255893|NCT00201292|"~     Diabetes is prevalent in schizophrenics and may be induced by antipsychotic treatments.~     Several retrospective studies have suggested that psychiatric patients exposed to atypical~     antipsychotics may be at a higher risk for developing diabetes and ketoacidosis. The~     association between these atypical antipsychotics and the onset of diabetes is further~     strengthened by observations of:~        1. the time sequence between the initiation of antipsychotic treatment and the onset of~          diabetes;~        2. remission after the discontinuation of medications; and~        3. re-emergence of diabetes following the re-introduction of atypical antipsychotics.~      The treatment emergent diabetes, along with other metabolic disturbances, represents a~     serious issue in the use of atypical antipsychotics. Major current debates and unresolved~     research issues which are also the focus of this proposal, are:~        1. schizophrenia per se, versus the use of antipsychotics, in triggering diabetes;~        2. whether there are differences between typicals and atypicals in such an effect;~        3. whether there are differences among different atypicals;~        4. whether, and to what extent, treatment emergent diabetes may be associated with, or~          independent of, weight gain, which also often is associated with the use of~          antipsychotics; and~        5. genetic and environmental risks in association with treatment emergent diabetes.~      The policy of some hospitals in Taiwan that discourages the use of atypical antipsychotics~     for new onset schizophrenia directs the investigators to a study design looking at the~     associated diabetes of both types of antipsychotics. Such a design may provide some hints to~     the unresolved research issues mentioned above.~      Meanwhile, a broader defined term, X-syndrome, or metabolic syndrome, is being used to~     describe the diabetic condition associated with antipsychotics. X-syndrome is a risky~     condition leading to cardiovascular diseases and diabetes, with insulin resistance as the~     major outcome, associated with two of the following conditions: truncal obesity (deposited in~     the thorax and abdomen, instead of the hips and thighs), high triglycerides, high low-density~     lipoprotein (LDL) cholesterol or hypertension. The proposed study will combine the phenotypes~     of diabetes and X-syndrome to explore the abnormal metabolism caused by antipsychotics,~     bridge important information gaps, and provide data contributing towards a better~     understanding of the risk and management of diabetes and X-syndrome associated with the use~     of antipsychotics. Three assessment tools, namely the Clinical Global Severity (Clinical~     Global Impressions - Severity) or the Positive and Negative Symptom Scale (PANNS), the~     Diabetes Risk Assessment (ADA) and the Life Style Survey, together with physical~     measurements, collect additional information for this study. Diabetes related biochemistry,~     including glucose, insulin, leptin, lipids and glycohemoglobin, will be measured to form a~     composite phenotype for further pharmacogenetic studies. Candidate genes involved in~     pancreatic beta cell insulin secretion will be examined in priority to see if they play a~     role in the development of the antipsychotics-induced diabetes.~   "
255894|NCT00201279|"~     The purpose of this study is to study the effect of 13-cis retinoic acid in preventing second~     primary malignancy in the oral cavity cancer patients after curative local treatment and to~     study the toxicity and compliance of 13-cis retinoic acid.~   "
255895|NCT00201266|"~     This study will evaluate the link between blood group antigens and asthma exacerbations.~   "
255896|NCT00201253|"~     The purpose of this study is to assess lung immune responses in patients with active~     pulmonary tuberculosis (TB) and in healthy control persons who are exposed to Mycobacterium~     tuberculosis in households of patients with TB or who are unexposed.~   "
255897|NCT00201240|"~     This study is a single arm Phase II, multicenter trial. It is designed to determine whether~     the anticipated endpoints for a T cell depleted transplant arm of a planned prospective~     randomized trial comparing T cell depleted and unmodified hematopoietic allografts are likely~     to be achieved in a multicenter study conducted by the Blood and Marrow Transplant Clinical~     Trials Network (BMT CTN or Network). The study population is patients with acute myeloid~     leukemia (AML) in first or second morphologic complete remission. The enrollment is 45~     patients.~      Based on published results of unmodified transplants from HLA-matched siblings applied to~     patients with AML in first or second morphologic complete remission, a significant~     improvement in results with a graft modified as specified in this protocol would be expected~     if disease-free survival (DFS) at 6 months was greater than 75%, the true incidence of~     transplant-related mortality at 1 year was less than 30%, and the DFS rate at 2 years was~     greater 70% for patients transplanted in first remission and less than 60% for patients~     transplanted in second remission. Additional secondary endpoints include the following: graft~     failure rate and incidences of acute grade II-IV and chronic graft-versus-host disease~     (GVHD). Additionally, the trial will have target specific doses of CD34+ progenitors and CD3+~     T cells to be obtained following fractionation with the CliniMACS system. Based on the~     results of this trial, a Phase III trial comparing T cell depleted peripheral blood stem cell~     transplants (PBSCT) with unmanipulated bone marrow or unmanipulated PBSCT will be designed.~   "
255898|NCT00201227|"~     To evaluate whether the innovative multimethod assessment process/participatory quality~     improvement (MAP/PQI) intervention increases adherence to multiple cardiorespiratory~     guidelines in primary care practice.~   "
255899|NCT00201214|"~     This study will determine the pharmacokinetics and safety of intravenous citrulline given to~     children undergoing cardiopulmonary bypass for the correction of congenital heart defects.~   "
255900|NCT00201201|"~     The purpose of this study is to reduce adverse self-medication practices in older adults with~     hypertension.~   "
255901|NCT00201188|"~     The purpose of this study is to improve anti-inflammatory medication adherence and asthma~     outcomes by using reports of peak flow monitoring to prompt communication between patients~     and their doctors.~   "
255902|NCT00201162|"~     To determine the effects of soy on lipids, lipoproteins and lipoprotein subclass in a sample~     of African-American and white postmenopausal women with low-density lipoprotein (LDL)~     cholesterol elevations that may increase their lifetime risk for cardiovascular disease but~     would not qualify for definite pharmacotherapy under current guidelines.~   "
255903|NCT00201149|"~     The purpose of this study is to test the effect of clinician counseling and cultural~     competence training on medication compliance and blood pressure (BP) control in patients with~     high BP.~   "
255904|NCT00201136|"~     This study will test the separate and combined effects of a continuous quality improvement~     (CQI) intervention for physicians (MDs) and a behavioral intervention for patients on blood~     pressure control.~   "
255905|NCT00201123|"~     This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb)~     infection and will modulate that response with interferon-gamma.~   "
255906|NCT00201110|"~     The purpose of this study is to test a measurement tool and a new training intervention for~     problem solving in self-management of high cardiovascular disease (CVD) risk in African~     Americans with type 2 diabetes.~   "
255907|NCT00201084|"~     The purpose of this study is to test the theory that a major factor in poor blood pressure~     (BP) control is that physicians fail to intensify antihypertensive therapy for their~     patients.~   "
255908|NCT00201071|"~     The purpose of this study is to test the effectiveness of a bilingual intervention in~     improving asthma care for low-income inner-city children enrolled in subsidized preschool~     childcare programs.~   "
255909|NCT00201058|"~     The purpose of this project is to refine and further evaluate an online asthma management and~     education program for urban teenagers. This project is a continuation of Puff City I, a~     project piloting and evaluating a tailored, school-based, computerized asthma education~     program for urban teenagers. In this second phase of research, a new version of software~     (Puff City II) will be created that will target resistance to change and relapse, and using a~     tested, theory-based approach to student recruitment, conduct a randomized trial to test the~     efficacy of this new software.~   "
255910|NCT00201045|"~     The purpose of this study is to test whether blood pressure control can be improved by~     physician education and feedback provided through the development of physician/pharmacist~     collaborative teams.~   "
255911|NCT00201019|"~     The purpose of this study is to evaluate the impact of physician/pharmacist collaborative~     teams on hypertension guideline adherence for patients with uncontrolled hypertension in six~     family medicine practice sites in Iowa.~   "
255912|NCT00201006|"~     To test the effectiveness of interventions designed to promote long-term weight management of~     obese women in medically underserved rural counties.~   "
255913|NCT00200993|"~     To investigate the separate effects of the amount of exercise and exercise intensity on~     cardiovascular risk factors in overweight men and women with mild to moderate dyslipidemia.~   "
255914|NCT00200980|"~     The purpose of the study is to follow the medical course of children with moderate to severe~     asthma and see how this relates to whether they have acid of non-acid gastroesophageal reflux~   "
255915|NCT00200967|"~     The purpose of this trial is to determine whether regularly scheduled use of an inhaled~     long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled~     corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental~     effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic~     receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly~     genotype.~   "
255916|NCT00200954|"~     Administration of probiotics to pregnant women from an atopic family and subsequently to~     their high-risk newborns results in prevention of the incidence or in a decrease of the~     severity of atopic disease during infancy.~   "
255917|NCT00200941|"~     This study is intended to determine whether topiramate is an efficacious and safe treatment~     for restless legs syndrome.~   "
255918|NCT00200928|"~     The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and~     related to the degree of inhibition of TH2-mediated disease.~   "
255919|NCT00200902|"~     This study will use measurements of depression symptoms and brain activity to determine what~     factors may influence an individual's response to treatment for depression.~   "
255920|NCT00200889|"~     This study will determine how vagus nerve stimulation affects human brain and autonomic~     activity.~   "
255921|NCT00200876|"~     This study will use brain imaging technology to examine chemical systems in the brain that~     suppress pain and stress when an individual has an expectation of pain relief.~   "
255922|NCT00200863|"~     This study will determine which color of light is most effective in stimulating a range of~     biological functions in humans including activation of sleep-wake regulatory system~     (alertness, performance, microsleeps, brain activity), activation of the nervous system~     (heart rate, temperature, blood pressure, breathing rate), and shifting the timing of the~     internal 24-hour (circadian) pacemaker.~   "
255923|NCT00200850|"~     This study will investigate sublingual immunotherapy (SLIT), a treatment involving antigens~     placement under the tongue to help asthma sufferers build a tolerance to the allergy-causing~     substances. Specifically, this study will determine the effectiveness of SLIT at two~     different dosing regimens for patients with intermittent mild asthma caused by dust mites.~   "
255924|NCT00200837|"~     These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and~     oral inflammation relief.~   "
255925|NCT00200824|"~     This study will determine the effects of soy products on in vitro surrogate cancer markers as~     well as bone density markers and quality of life parameters in men and women. This study will~     also determine concentrations of isoflavones (naturally occurring plant compounds that act~     like estrogen in the body) in prostate tissue that has been removed during prostatectomy, as~     well as in the blood.~   "
255926|NCT00200798|"~     There is accumulating evidence from various sources that extracts from the milk thistle plant~     can be useful in the treatment of a variety of liver ailments as well as other disorders.~     This investigation will essentially be composed of two individual normal volunteer studies of~     milk thistle. The first study will assess the rate and extent of absorption of components of~     a standardized botanical extract obtained from the milk thistle plant. This first study is~     termed a bioavailability study. This investigation will take approximately 8 weeks and~     involve 10 clinic visits. Secondly, a drug interaction study will be performed. This is an~     assessment study of the potential for this botanical extract to interact with other~     prescription or over-the-counter medications. This study is also expected to take~     approximately 8 weeks but will involve 18 clinic visits. In both studies all subjects will~     receive the same milk thistle supplement and no placebo will be administered.~   "
255927|NCT00200785|"~     This study will seek to identify the compound(s) in garlic that is (are) responsible for its~     ability to prevent the formation of blood clots (prevent platelet aggregation) and to~     determine the maximally effective dose and duration of the benefits. This study will also~     determine whether cooked garlic (garlic powder added to boiling water, no allicin present)~     is as effective as fresh garlic (garlic powder added to ambient water, high allicin~     present) and, if more than one compound is involved, and whether their combined effects are~     more significant than the effects of each compound alone.~   "
255928|NCT00200759|"~     The purpose of this study is to evaluate the potential of cranberry juice to interact with~     conventional drugs. This study will also determine the the amount of cranberry flavonoids~     that appear in the blood and in the urine.~   "
255929|NCT00200746|"~     The purpose of this study is to test the effectiveness of the amino acid arginine in reducing~     liver injury in individuals with alcohol-related hepatitis.~   "
255930|NCT00200733|"~     This study examined the experiences of individuals undergoing acupuncture to gather~     information on patient-provider communication and on the therapeutic effects of acupuncture.~   "
255931|NCT00200720|"~     This study will examine the effects of a low carbohydrate diet versus a high carbohydrate~     diet on weight loss.~   "
255932|NCT00200707|"~     Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can~     be used to improve cardiac function in patients after acute myocardial infarction. In this~     randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow~     cells could improve myocardial viability at 3 and 12 months' follow-up.~   "
255933|NCT00200694|"~     Determine the best strategy for proteinuria lowering in patients with proteinuria > 1 g/day~     receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of~     diuretic dosage.~   "
255934|NCT00200681|"~     This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480~     patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously~     treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment~     plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by~     autograft as first-line therapy, as the investigators try to compare the complete remission~     (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.~   "
255935|NCT00200668|"~     Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy~     in multiple myeloma patients.~   "
256025|NCT00199498|"~     The purpose of this study is to examine whether RV (right ventricular)septal pacing has any~     effect on LV ( left ventricular) function than RV apical pacing in patients who require~     ventricular pacing.~   "
255936|NCT00200655|"~     Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of~     immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is~     quite limited, they are not well tolerated and they have a very high cost. Recent works~     showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called statins).~     In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and~     progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in~     vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the~     blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was~     associated with a decreased lesional activity assessed by MRI. Statins are well tolerated~     drugs, used for many years, with a low cost and with a putative efficacy in MS. The~     investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a~     double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.~   "
255937|NCT00200642|"~     Gastroesophageal reflux disease is a frequent disease and which heavily affects the patients'~     quality of life. To alleviate symptoms and ease the healing of lesion, patients very often~     need to continuously take anti-secretory drugs (Proton pump inhibitors or PPIs), which,~     despite their efficiency, do not cure the disease. For these PPI dependent patients, an~     anti-reflux surgery (fundoplication often made by coelioscopy) is a possible alternative but~     it has a significant morbidity rate and even an estimated post-operative mortality of 0.8%~     outside of expertise centres. Therefore, new therapeutic endoscopic approaches, supposed to~     be less invasive and less expensive than surgery have been developed during the last three~     years. Among them, radiofrequency (Stretta® procedure) consists in administering a high~     frequency current in the cardia area, in order to induce thanks to a thermal effect a~     sub-mucous remodelling and a modification of the compliance of the cardia regionThe aim of~     this project carried out in 8 French centres and 2 European centers is to assess through a~     randomised trial, the efficiency of radiofrequency on PPI dependent patients. The study will~     be carried out in 2 phases with patients who have been fully informed of the project~     statement, and particularly of the potential risks of the radiofrequency technique and have~     given their written acceptation to participate to the study.The first phase, which will last~     6 to 11 weeks, will aim at making sure that patients are PPI dependent and define their~     needs. After this initial phase, patients will be randomised between those who will carry on~     with the PPI treatment or the radiofrequency treatment. The follow up after this~     randomisation will last one year. The first assessment of the therapeutic efficiency will be~     done at 6th month. The 6 additional follow up months will be required for the assessment of~     mid-term side effects of the treatment and the rate of symptomatic recurrences.~   "
255938|NCT00200629|"~     The purpose of this study is to compare the 2-year cardiac outcomes for women with limited~     exercise capability based on the resuls of either pharmacological stress myocardial perfusion~     imaging or a combined protocol that incorporates both exercise and pharmacological stress.~     The goal of the study is to compare these two methods for patient tolerability, safety and~     prognostic value~   "
255939|NCT00200616|"~     Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial~     prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).~   "
255940|NCT00200603|"~     The aim of the study is to compare radiological behavior of blocks of macroporous~     phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus~     osteotomy.~   "
255941|NCT00200590|"~     This is a randomised trial comparing the efficacy of 3 different analgesic strategies in~     newborns on prostaglandin for ductus dependent congenital heart disease.~   "
255942|NCT00200577|"~     The objective of this multicentric Phase III study is to confirm the results of the phase~     I-II study (Dreno B & Al. Cancer Immunol Immunother 2002; 51: 539-456) which demonstrated the~     preventive effect of a treatment by TIL (Tumor Infiltrating Lymphocytes) combined with IL2~     (Interleukin 2; low dose injected subcutaneously) on the metastatic relapse in the stage III~     melanoma patients with only one invaded lymphnode.~   "
255943|NCT00200564|"~     The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in~     adults but remains unproved in children. The investigators' purpose is to evaluate the~     effects of continuous intravenous small doses of ketamine versus placebo to improve the~     quality of postoperative analgesia in children (6 months to 6 years of age). Caudal~     anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a~     non-steroidal anti-inflammatory and continuous intravenous nalbuphine.~   "
255944|NCT00200551|"~     The trial is planned as a multicentric, randomized, prospective, open study in accordance~     with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with~     chronic renal insufficiency, included in the French national waiting list of the~     Establishment Français des Greffes [French Transplants Institution] and receiving a first~     renal transplant will be included, after signed agreement, in this study. All the patients~     will receive organs taken from brain-dead subjects. The patients will be given~     immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ~     cyclosporin. One group of 100 randomised patients will be given standard corticosteroid~     therapy as well during the first six months following the transplant. This group will be~     compared with a second group of 100 randomised patients who will be given a single dose of~     corticosteroids. The main aim of this study is to evaluate the number of acute rejection~     episodes in patients given a first renal transplant and subjected to an immunosuppressant~     protocol not containing corticosteroids. The hypothesis which is proposed is that, in the~     absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus),~     antilymphocyte serum results in a certain state of tolerance in respect of the allograft.~     The second objective concerns the beneficial effect which the absence of corticosteroids may~     have on short- and long-term postoperative morbidity and mortality. One may in fact assume~     that the absence of corticosteroids will result in an extension of the transplant patient's~     life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular~     complications are the most frequent cause of death after a renal transplant.~   "
255945|NCT00200538|"~     The purpose of this trial is to assess the efficacy and tolerability of memantine~     (anti-excitotoxic, neuroprotective treatment currently used in Alzheimer's disease [AD]) in~     frontotemporal dementia patients after a one-year treatment.~   "
255946|NCT00200525|"~     Study to measure the continued effectiveness of apomorphine after previous exposure of at~     least three months duration.~   "
255947|NCT00200512|"~     The objective of this study was to measure the continued efficacy of apomorphine after~     previous exposure of at least three months duration.~   "
255948|NCT00200499|"~     The study was conducted to determine the long-term safety and efficacy of nebivolol in~     patients with mild to moderate hypertension. This was an extension of the Phase III dose~     ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction~     with add-on antihypertensive therapy.~   "
255952|NCT00200447|"~     This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone~     may work in the brain. This research study uses [123I]-IBZM and dynamic SPECT imaging to~     determine the amount and the duration of dopamine release from specific regions in the brain~     after treatment with either the combination of carbidopa/levodopa or the combination of~     carbidopa/levodopa/entacapone.~   "
255953|NCT00200434|"~     The purpose of this study was to contrast the efficacy and safety of 3 dose levels of~     nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for~     3 months, in patients with mild to moderate hypertension~   "
255954|NCT00200421|"~     The purpose of this study is to determine the effects on exercise capacity of nebivolol~     compared to atenolol in hypertensive patients.~   "
255955|NCT00200408|"~     This study will look at the genetic profile of cells taken from the oral cavity of healthy~     college students who smoke and who do not smoke cigarettes. This will be done using a small~     brush similar to that used in Pap tests for cervical cancer detection. Our aim is to~     determine if smoking causes early genetic changes in the DNA of these cells such as have been~     seen in the cells of cancerous tumors of the head and neck area and nearby healthy tissues.~     This will be correlated with data from subject questionnaires to assess tobacco use, and~     other behavior and demographic information.~   "
255956|NCT00200395|"~     The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the~     treatment of non-small cell lung cancer and to further study its side effects. We would also~     like to estimate disease-related symptom improvement rates using a questionnaire.~   "
255957|NCT00200382|"~     The purpose of this study is to develop new treatments that will hopefully result in the~     relief of symptoms and prolongation of life. For this reason, your doctors have offered you~     treatment with a new experimental drug called PS 341.~   "
255958|NCT00200369|"~     The hypothesis of this study is that the level of adherence necessary to achieve HIV~     virologic suppression with a ritonavir boosted protease inhibitor regimen (i.e.~     lopinavir/ritonavir) is less than the 95% rate observed in the published literature with~     unboosted regimens.~   "
255959|NCT00200356|"~     This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study~     on acute ischemic stroke. The primary endpoints were the rate of patients with modified~     Rankin Scale score of 0-1 at 3 months.~   "
255960|NCT00200343|"~     This study is a 24-week multicenter, randomized, double-blind control trial with~     ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary~     objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day~     to that of 150mg/day and the safety of UDCA treatment.~   "
255961|NCT00200330|"~     The obesity epidemic observed in recent years can be largely attributed to an obesogenic~     environment that encourages overeating and sedentary lifestyles. Behavioral weight control~     treatment, the most empirically validated intervention approach, produces initial weight~     losses of 10%; however, maintenance of initial weight loss and behavior change has not been~     achieved. These disappointing long-term results may reflect the fact that participants are~     given only minimal, indirect instruction on how to change their environment to support their~     new weight-regulating behaviors. While in theory, the behavioral model emphasizes~     environmental antecedents and consequences of eating and exercise, in practice, only 1 to 2~     sessions in standard treatment are dedicated to stimulus control-types of skills. By teaching~     weight control skills in a contextual vacuum, participants remain vulnerable to the same~     environmental influences that maintained their unhealthy eating and exercise habits. Given~     that the majority of eating and exercise is home-based, a logical step in strengthening~     behavioral treatment and moving toward an ecological model of behavior is to expand the focus~     of treatment from the individual to the individual plus their home environment. We propose to~     test the long-term impact of a behavioral weight control program designed to directly modify~     both the physical and social home environment of weight loss participants. Two hundred~     overweight and obese men and women will be randomly assigned to either 18 months of standard~     behavioral treatment (SBT) or 18 months of standard behavioral treatment plus direct~     modifications to the home environment (SBT+Home). SBT+Home will incorporate many strategies~     that have shown promise in improving weight loss (e.g., food and exercise equipment~     provision, spouse involvement) but will be the first to study both physical and social~     factors within the home simultaneously and will be the longest examination of the home~     environment conducted to date. Participants and spouses will be assessed at baseline, 6, 12,~     and 18 months. We hypothesize that by broadening the focus of treatment from the individual~     to the individual plus their home environment, SBT+Home will produce both better long-term~     weight loss and better maintenance of initial weight loss and behavior change. This home~     environmental approach, if successful, has potential applications to the maintenance of other~     important health behaviors.~   "
255962|NCT00200317|"~     The purpose of this study is to examine if an individually tailored Internet intervention is~     more efficacious than an individually tailored print-based intervention and standard Internet~     intervention for physical activity adoption and maintenance among sedentary adults.~   "
255963|NCT00200304|"~     The Internet has been used effectively in behavioral weight loss programs. Most of these~     programs have involved a therapist who provides email counseling. The purpose of this study~     was to determine whether a computer-assisted weight loss program could be developed (that~     would use pre-programmed computer generated messages rather than human generated messages)~     and whether this program would be as effective as the therapist-assisted weight loss program.~   "
255964|NCT00200291|"~     The reinforcing value of food, or how much a person wants a food, is an important~     determinant of food intake. Thus far, food reinforcement has only been studied in laboratory~     settings, and no studies have examined whether the reinforcing value of food is altered when~     dietary changes are made. The chronic deprivation that occurs when a low-calorie, low-fat~     diet is implemented for weight loss may increase the reinforcing value of all foods, but~     particularly for restricted high-fat foods. Greater increases in the reinforcing value of~     high-fat foods relative to low-fat foods may be detrimental for sustaining newly adopted~     eating behaviors that produce weight loss, whereas greater increases in the reinforcing value~     of low-fat foods relative to high-fat foods may aid in maintaining healthy eating behaviors.~     The aim of this application is to measure food reinforcement in a clinical setting to~     determine if food reinforcement changes when a traditional weight loss diet is prescribed.~     For this ancillary study, 147 volunteers will be recruited from the 165 overweight and obese~     women participating in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) at The~     Miriam Hospital. As part of PRIDE, these participants will be randomized in a 2-to-1 ratio to~     either a 6-month weight loss intervention or usual care. Assessments of food reinforcement,~     dietary intake, and weight will occur at 0 and 6 months. Given that the intervention group~     changes their diet relative to the usual care group, it is hypothesized: 1) the intervention~     group will have greater increases in the reinforcing value of both high- and low-fat foods~     than the usual care group from 0 to 6 months; and 2) within the intervention group, decreases~     in frequency of consumption of high-fat foods will be related to increases in the reinforcing~     value of high-fat foods from 0 to 6 months. These results will lead to a novel line of~     research, examining the relationship between food reinforcement and weight loss maintenance,~     so that diets can be designed to promote changes in food reinforcement that aid in sustaining~     dietary changes and weight loss.~   "
256047|NCT00199212|"~     The main objective of this study is to determine the feasibility of the combination of the~     proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to~     determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and~     3-weekly.~   "
256048|NCT00199186|"~     The aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more~     effective as up-front remission induction therapy than conventional multi-agent induction~     chemotherapy for elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment~     is better tolerated, and whether subsequent combination therapy with imatinib and~     chemotherapy of approximately a 1 year duration is tolerable and effective with respect to~     maintaining remissions.~   "
255965|NCT00200278|"~     The objective of this study is to determine the differential effect of intervention delivery~     channel (phone versus print versus wait list control) on physical activity adoption and~     maintenance in previously sedentary adults. Both delivery channels have been found to be~     effective, but telephone-based interventions require more commitment on the part of the~     subjects and are more labor intensive than print-based interventions. Thus, we will conduct a~     randomized controlled clinical trial comparing three groups: 1) telephone-based~     motivationally-tailored individualized feedback; 2) print-based, motivationally-tailored~     individualized feedback; 3) minimal contact waiting list control condition (receive~     intervention after 12 months as controls). Two hundred and twenty-eight healthy, sedentary~     women and men ages 18-65 will be randomly assigned to one of the two interventions or the~     waiting-list control condition. Our primary hypothesis is that individuals randomized to~     either phone or print conditions will exhibit significantly higher levels of physical~     activity participation at 6 and 12 months than individuals in the waiting list control~     condition. And, in addition, that subjects randomized to the telephone condition will exhibit~     significantly higher levels of physical activity participation at 6 and 12 months than those~     in the print condition.~   "
255966|NCT00200265|"~     Recommendations for treatment of childhood obesity in a primary care setting have been~     developed. These recommendations include beginning treatment with young children, focusing~     treatment on the parent so the parent can assist the child in making changes, and changing 2~     or 3 very specific eating or activity behaviors (i.e., eat less snacks, rather than eat less~     calories). The effectiveness of these recommendations has never been evaluated. This~     project's goal is to develop, implement, and evaluate a 6-month childhood obesity~     intervention meeting these recommendations. Another goal of the project is to compare two~     different approaches, focusing on either decreasing intake of two unhealthy foods or~     increasing intake of two healthy foods, for changing eating behaviors during treatment. Two~     hundred ten children, between the ages of 4 to 9 years, who are at risk for overweight or~     overweight, based upon weight and height standards, will be randomized to one of three~     treatments: 1) a Newsletter treatment (provided with information on healthy eating only); 2)~     a Parent Program that decreases intake of sweet/salty snack foods (< 3 servings/week) and~     sweetened drinks (< 3 servings/week); or 3) a Parent Program that increases intake of fruits~     and vegetables (5 servings/day) and low-fat dairy products (2 servings/day). Children's~     height and weight will be measured at 0, 3, 6, 9, and 12 months. This project will determine~     if the recommendations for treatment are effective, and if focusing on decreasing intake of~     unhealthy foods or increasing intake of healthy foods produces a better long-term weight loss~     outcome.~   "
255967|NCT00200252|"~     Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and~     therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh~     or into a vein. However, it is not known which route is better.This study will test which~     dose and route of oxytocin is best in reducing blood loss following vaginal delivery.~   "
255968|NCT00200239|"~     A contributing factor to the rising prevalence of obesity may be increased portion sizes.~     However, the effect of portion size has not been studied independent of the effect of~     quantity of food in the context of a behavioral weight loss program. Providing pre-portioned~     single servings of food may make it easier to reduce caloric and dietary fat intake improving~     weight loss. In addition, breakfast skipping is associated with obesity and breakfast~     consumption is associated with weight loss success. Therefore, the objective of the proposed~     study is to investigate the effect of portion size on consumption of provided breakfast foods~     in the context of a behavioral weight loss program. Participants will be randomized to 1 of 2~     standard 12-week behavioral obesity interventions. The first intervention, serving as a~     control, will provide participants with breakfast foods in non-portioned containers~     (Standard). A second intervention will provide participants with the same type and quantity~     of breakfast foods but they will be provided in pre-portioned single servings (Portion).~     Dependent variables include the number of calories consumed from the provided foods as well~     as overall caloric and fat consumption. If the provision of food in pre-portioned servings is~     effective at decreasing intake, future directions include conducting longer interventions to~     improve long-term weight loss outcomes in standard behavioral interventions.~   "
255969|NCT00200226|"~     An endometrial biopsy involves a thin tube being passed through the cervix (opening of the~     uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort~     with this procedure especially if the cervix is not dilated or opened. Previous research has~     suggested that taking a drug called misoprostol may help the cervix to start to dilate or~     open. This study will see if misoprostol will help open the cervix for an endometrial biopsy,~     to lessen the discomfort and make the biopsy easier to perform.~   "
255970|NCT00200213|"~     Specific Aims: Environmental factors contributing to overconsumption, such as larger food~     portion sizes, may be contributing to the obesity epidemic. The objective of the proposed~     study is to examine the independent and combined effects of portion size and quantity of food~     on intake in normal weight males and females. Participants will be randomly assigned to one~     of four conditions varying in the portion size and quantity of junk food provided: small~     quantity of food packaged in small portions (SSP), small quantity of food packaged in large~     portions (SLP), large quantity of food packaged in small portions (LSP), and large quantity~     of food packaged in large portions (LLP). A box containing four different junk foods,~     packaged according to one of the four conditions, will be given to participants to take home~     for three days. The total amount of food consumed from the box over the three days will be~     measured. It is anticipated that portion size and quantity of food, both independently and~     combined, will influence intake, such that larger portion sizes and quantity of food provided~     to participants will produce greater intake.Subject Population: We propose to recruit 60~     healthy men and women, aged 18-50 years, with a body mass index (BMI) of less than or equal~     to 28. Participants will be non-smokers, unrestrained eaters, and have no known food~     allergies to the foods used in the investigation.Methods/Design: Participants will be~     randomly assigned to one of four conditions, varying in portion size (small versus large) and~     quantity of food provided (small versus large). A box containing four junk foods, packaged~     according to one of the conditions, will be provided to participants. They will be encouraged~     to eat as much or as little of the food as they want, but to at least taste each of the four~     foods over the three-day period. During this time, they will be instructed to not eat any~     other junk foods. At the end of the three-day period, participants will return the box with~     any remaining uneaten junk food.Data Analyses: The dependent variables, the amount of grams~     and kcals consumed from the provided junk foods, will be examined between the four different~     conditions.Significance: If portion size and quantity are related to intake, subsequent~     studies will develop clinical interventions related to reducing portion size and/or quantity~     of food available in the household.~   "
255971|NCT00200200|"~     The purpose of this study is to determine whether the addition of bevacizumab, to hepatic~     arterial therapy with floxuridine (FUDR) and dexamethasone (Dex) (regional chemotherapy), and~     either oxaliplatin or CPT-11, plus 5-fluorouracil and leucovorin (systemic chemotherapy) will~     increase disease free survival in patients who have undergone liver resection. The patient~     will be randomized (a computer generated decision as in the flip of a coin) to receive, or~     not to receive bevacizumab in addition to regional and systemic chemotherapy.~   "
255972|NCT00200187|"~     You are being asked to join the study because you have early stage prostate cancer and will~     have your prostate removed. The purpose of this study is to compare blood loss during surgery~     among two types of anesthesia. One type is general anesthesia. It puts you in a deep enough~     sleep that you will not feel anything. It also keeps your blood pressure low, which might~     decrease bleeding. The second type is combined spinal-epidural anesthesia. For this type, a~     small catheter is placed in your spinal canal through your back. Anesthesia given through the~     catheter makes your body numb from the waist down, so the sleep you would be in is not so~     deep. Your blood pressure would remain in your normal range. After surgery, the catheter~     remains in place to treat your pain, but your body would not be numb. When you wake up after~     general anesthesia, you would receive pain medicine through a vein in your arm.~      Both types are used at Memorial Hospital. They are accepted forms of anesthesia. We will be~     looking at blood loss between these two types for patients having their prostate removed. We~     also want to learn about the side effects of each anesthesia type, and assess pain that you~     experience after surgery.~   "
255973|NCT00200174|"~     The purpose of this research study is to learn about the effects of two drugs when they are~     given together. The names of the drugs are raloxifene and exemestane.~      Raloxifene is a drug that is related to estrogen. In the liver and bone, it acts like~     estrogen. In the breast and uterus it acts like an anti-estrogen. It has been used in~     postmenopausal women to prevent a disease called osteoporosis. This is a disease that~     decreases bone strength over many years and may finally lead to bone fractures. In a group of~     women who were taking the drug, it also seemed to decrease the chances of breast cancer and~     possibly endometrial cancer (cancer of the uterus). Therefore, we want to study it further to~     see if it prevents breast cancer. We also want to find out if it may be even better in~     preventing breast cancer if it is given with another drug.~      The other drug in this trial is exemestane. Exemestane is a type of drug that works to~     decrease estrogen levels in postmenopausal women. This type of drug is used in women for the~     treatment of breast cancer. Before we can decide if the two drugs combined are better for~     preventing breast cancer, we must first test these drugs together to make sure that they are~     safe. This safety testing is the purpose of this trial.~   "
255974|NCT00200161|"~     Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the~     study to see if it is possible to increase the benefit of temozolomide when given after~     radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer~     when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide~     than patients treated with radiotherapy alone. Patients will receive standard low dose~     temozolomide during radiation. After radiation, they will be randomized to receive either~     more intense temozolomide or continuous low dose temozolomide.~   "
255975|NCT00200148|"~     With a major liver or pancreas operation, there is a chance that one will require a~     transfusion of blood products (either red blood cells or plasma). This may be necessary~     during the operation or a few days after surgery. The surgeons at Memorial Sloan-Kettering~     Cancer Center perform a very large number of liver or pancreas resections every year and have~     pioneered techniques that minimize bleeding during the operation. Even so, liver or pancreas~     operations such as the one that will be undergone carry a 50% chance of requiring a~     transfusion. A technique that might lower the need for transfusions is called acute~     normovolemic hemodilution (ANH). ANH was first introduced over twenty years ago and has been~     used in many types of operations, including liver or pancreas resection. The studies done on~     ANH at other hospitals suggest that it may help conserve blood. Researchers at Memorial~     Sloan-Kettering Cancer Center are conducting a study to determine if ANH is better than the~     'standard technique' that is currently used in all patients. The purpose of this study is to~     find out which of the two techniques is better.~      The purpose of the study is to see if ANH lowers the need for the transfusion of blood~     products during and after liver or pancreas resection.~      The second purpose of the study is to see how ANH changes the length of the operation, the~     length of time one spends in the hospital, and the complication rate after surgery. The~     researchers will also see if ANH requires any changes in the administration of anesthesia.~   "
255976|NCT00200135|"~     The purpose of this study is to find out how many helmeted versus non-helmeted motorcycle~     accident victims (MCA) sustain head and/or face injuries. Also, we will find out how much it~     costs to get medical care for head and face injuries in helmeted versus non-helmeted~     motorcycle victims. Finally, we will compare how long it takes helmeted versus non-helmeted~     motorcycle victims with face and head injuries to return to work.~   "
255977|NCT00200122|"~     The purpose of this study is to characterize the pain coverage capability of the RESTORE~     spinal cord stimulation (SCS) and assess health outcomes.~   "
255978|NCT00200109|"~     Background: Medically intractable chronic migraine (CM) is a disabling illness characterized~     by headache greater than 15 days per month.~      Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to~     obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM.~     Eligible subjects received an occipital nerve block, and responsers were randomized to~     adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.~   "
255979|NCT00200096|"~     In a previous study, we found that acupuncture may decrease fatigue. The aim of this study is~     to determine whether acupuncture is helpful in reducing fatigue in cancer patients treated~     with chemotherapy. We will also study how fatigue, quality of life, mood, level of physical~     activity. This study will involve about 88 patients.~   "
255980|NCT00200083|"~     The purpose of this study is to test the effect of an implanted device that stimulates the~     stomach to help obese patients lose weight.~   "
255981|NCT00200070|"~     The therapy under investigation involves an implanted Medtronic neurostimulation system to~     relieve symptoms of angina pectoris pain. Electrical impulses are applied to targeted areas~     of the spinal cord through an implanted lead (a flexible insulated wire) that is powered by~     an implanted battery.~   "
256049|NCT00199173|"~     This is a Phase III trial comparing hepatic intra-arterial injection of Yttrium-90~     microspheres (selective internal radiation [SIR] spheres) versus infusional intravenous (IV)~     5FU in colorectal cancer metastatic to the liver only and refractory to standard IV~     chemotherapy.~   "
256050|NCT00199160|"~     This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006~     in patients with recurrent and/or metastatic head and neck cancer.~   "
255982|NCT00200057|"~     Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel~     movement) in order to expel it at a proper time and place. Patients who suffer from FI may~     experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a~     bowel movement but cannot hold the stool until an acceptable time and place). FI is not a~     life-threatening disease, but it is often profoundly distressing and socially incapacitating.~      If a patient is suffering with symptoms of chronic FI despite trying oral medications,~     biofeedback and/or other more conservative treatments, a patient may be eligible to~     participate in a clinical research study to evaluate the safety and effectiveness of sacral~     nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120)~     patients will be implanted with medical devices and followed closely for twelve months, and~     then once a year after that until the study closes. There are up to 20 centers in the United~     States.~   "
255983|NCT00200044|"~     The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair~     System to provide symptomatic relief is subjects with gastroesophageal reflux disease.~   "
255984|NCT00200031|"~     A study to examine the impact that Interstim Therapy for Urinary Control has on health care~     utilization and costs within a health care system and the satisfaction with treatment~     expressed by patients using this therapy.~   "
255985|NCT00200018|"~     The purpose of this study is to test the effect of an implanted device that stimulates the~     stomach on weight loss in patients suffering from obesity and type 2 diabetes.~   "
255986|NCT00200005|"~     Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with~     InterStim Therapy to treat fecal incontinence or constipation~   "
255987|NCT00199992|"~     Comparison of wound healing treatments; platelet gel vs. control~   "
255988|NCT00199979|"~     The study will compare the immuno-virological efficacy, and safety, of a once daily~     antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily~     association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1~     infected subjects, with CD4 cell count below 350/µL or below 15%, whatever the viral load.~     Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case~     of failure) will also be provided, as well as adherence rate and quality of life in respect~     of the treatment arms.~   "
255989|NCT00199966|"~     The purpose of this research is to compare how safely and how well this medicine works in~     treating children and teenagers between the ages of 6 and 17 years with a diagnosis of~     Bipolar Disorder.~   "
255990|NCT00199953|"~     Objectives of this study are:~        -  To quantitatively evaluate the relationship between extraesophageal manifestations of~          gastroesophageal reflux (EER) and postnasal drainage(PND)in a group of patients without~          radiographic or endoscopic evidence of sinonasal inflammatory disease.~        -  To assess the efficacy of BID proton pump inhibitors (PPI) in the management of patients~          with symptomatic postnasal drainage.~   "
255991|NCT00199940|"~     The purpose of this research is to determine if Ziprasidone is safe and effective for use in~     children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment~     leads to weight changes in children.~   "
255992|NCT00199927|"~     End stage renal disease (ESRD) is rapidly growing worldwide. Patients with ESRD have~     increased morbidity and mortality mostly because of a dramatic excess of cardiovascular~     disease. Thus, preventing or limiting the progression of chronic nephropathies, in addition~     to limit the incidence of ESRD, may also postpone death. Drugs that inhibit the renin~     angiotensin system, such as Angiotensin-Converting-Enzyme inhibitors (ACEi) and Angiotensin~     II receptor antagonists (ATA), are reno- and cardio-protective in the long-term. There are~     data that statins,in addition to limit cardiovascular events may have specific~     reno-protective properties.~      Thus we designed a study aimed to evaluate whether statins associated to ACEi and ATA may~     have an additional reno-protective effect.~      ESPLANADE is a multicenter, prospective, randomized, parallel group study in which, after 2~     months treatment with ACEi and ATA, two groups of 90 patients, with or without type 2~     diabetes, are randomized to 6 months Fluvastatin (40 or 80 mg/day) treatment YES or NO.Twenty~     Italian Nephrology Units are involved in the trial. The study is fully coordinated by the~     Clinical Research Center for Rare Disease Aldo e Cele Daccò, Villa Camozzi, Ranica.~   "
255993|NCT00199914|"~     The purpose of this study is to determine whether shortwave diathermy is effective in~     reducing knee pain and increasing function of the patients with knee osteoarthritis.~   "
255994|NCT00199901|"~     The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine~     improves outcomes for people with Malignant Melanoma which has been removed, but is at high~     risk of relapse.~   "
255995|NCT00199888|"~     The purpose of this study is to see if an antibody (cG250)attached to a radioactive substance~     (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled~     for surgery.~   "
255996|NCT00199875|"~     This is a phase 1 study that will only be carried out at Memorial Sloan-Kettering Cancer~     Center. Patients will receive a radiolabeled antibody, called Yttrium-90 chimeric G250~     (90Y-cG250).The goal of a phase 1 trial is to establish a safe dose range based on side~     effects;in other studies, these side effects have been reversible and lasted a short time~     (hours to days). If possible, the trial will also give us an idea of how well the drug might~     work in treating your disease.~   "
255997|NCT00199862|"~     The purpose of this study is to determine whether our drug, 124I-huA33, can safely detect~     colorectal cancer.~   "
255998|NCT00199849|"~     To estimate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by PMED in~     patients with tumor type known to express NY-ESO-1 or LAGE-1 using frequency, severity, and~     duration of treatment-related adverse effects as endpoints.~   "
255999|NCT00199836|"~     This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with~     2 other agents to help stimulate the immune system. Peptides are small fragments of every~     protein. These peptides are normally found in the testis and the placenta. They have also~     been found on various types of cancer cells. The purpose is to stimulate the immune system to~     react against the peptides that are found on cancer cells~   "
256000|NCT00199823|"~     Objectives~      Intracoronary transplantation of different cell populations have been used in acute~     myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study~     is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells~     (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.~      Design~      The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with~     acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are~     randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days~     after PCI or to control. Left ventricular function, exercise capacity, biochemical status,~     functional class, quality of life and complications are validated at baseline and during a~     12-month follow up.~   "
256001|NCT00199810|"~     This trial is examining hemodynamic measurements in women with serious preeclampsia.~   "
256002|NCT00199797|"~     Although treatment for metastatic colo-rectal cancer has improved significantly over the~     recent years, it still remains a significant health problem representing the leading cancer~     by incidence in the United States of America. In search for new therapies monoclonal~     antibodies have been developed to specifically target human colon cancer cells. huA33 is an~     antibody that reacts with the A33 antigen which is produced by colorectal cancers. Prior~     studies have shown that application of the huA33 antibody may delay the growth of tumor cells~     producing the respective antigen. Oxaliplatin and 5-FU are cytotoxic agents which are~     considered as standard treatment in metastatic colorectal cancer. Leucovorin is a vitamin~     which enhances the effect of 5FU. Eligible patients with advanced colorectal cancer will~     receive huA33, 10 mg/m2 by intravenous (IV) infusion weekly for twelve weeks. On Study Day 15~     (week 3), 5-FU, leucovorin (folinic acid), and oxaliplatin will be administered every 2 weeks~     for 10 weeks. Patients will be evaluated weekly for toxicity. Blood samples will be obtained~     every week for hematology and serum biochemistry analysis and for determination of human~     anti-human antibody (HAHA). In patients with measurable disease, tumors will be assessed by~     the appropriate scan at baseline and at the end of the thirteen week cycle. The primary~     objective of this study is to assess the safety of huA33 + 5FU + leucovorin + oxaliplatin.~     The secondary objective is to measure the immunogenicity of huA33 when given in combination~     with 5FU plus leucovorin with oxaliplatin and to document tumor responses.~   "
256003|NCT00199784|"~     The purpose of this study is to determine the effect of low dose versus standard dose spinal~     anesthesia with and without intravenous phenylephrine-infusion on blood pressure, cardiac~     output and systemic vascular resistance.~   "
256004|NCT00199771|"~     The purpose of this study is to determine whether infusion of hypertonic saline dextran~     attenuates the inflammatory response and the water overload, during and after major cardiac~     surgery in small children.~   "
256005|NCT00199758|"~     The optimal strategy in advanced non small cell lung cancer with stable disease is not well~     known. There is no published study assessing an early change of chemotherapeutic drugs in~     these patients.Accordingly, we conduct this trial with the objective to improve the rate of~     objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine~     association for patients with stable diseases (SD).~   "
256006|NCT00199745|"~     The primary objective of the study is to investigate whether differences in atorvastatin~     metabolite ratios might have a positive or negative predictive value in diagnosing~     atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.~   "
256007|NCT00199732|"~     Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic~     hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the~     liver.~      Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment.~      The major interest of this marker is that it can be measured by a simple blood test instead~     of a liver biopsy.~   "
256008|NCT00199719|"~     Peg interferon and ribavirin currently represent the standard approved association for~     treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is~     expected to gain about 10 % of sustained virological response (SVR) . Unfortunately, about 50~     % of the patients remain relapsers or virological non responders. The main predictive factors~     of SVR are HCV genotype and body weight (BW). The impact of the drug pharmacological~     properties, particularly those of ribavirin requires complementary studies. This drug has a~     large distribution volume and its concentrations display large inter-individual variability.~     Two studies performed in HCV patients found no correlation between ribavirin dose adjusted on~     BW and a single ribavirin time point serum concentration at steady state.~      The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of~     ribavirin in hepatitis C patient~   "
256009|NCT00199706|"~     The purpose of this study is to determine whether 7.2% NaCl in 6% hydroxyethyl starch will~     lower intracranial pressure (ICP) in SAH-patients with normal or moderately elevated ICP in a~     placebo controlled study, and to describe the haemodynamic effects.~   "
256010|NCT00199693|"~     This study looks at hemodynamic and respiratory function in healthy pregnant women; it is a~     longitudinal study.~   "
256011|NCT00199680|"~     In cervical cancer prognosis factors are size of the tumour, pelvic and para-aortic lymph~     nodes involvement. The initial treatment taking is determined by lymph node evaluation.~      Early stage cervical cancers at their very beginning, with no lymph node involvement, will be~     treated either by surgery only or by radiotherapy only, or by both at the same time. At~     advanced stages, from proximal IB to IIB with bad prognosis (tumour larger than 4 cm and~     pelvic lymph node involvement), as well as for cancers up to distal stages IIB, III and IVA,~     treatment relies on radio-chemotherapy, either alone or pre-surgery.~      The pre-therapeutic complete examination of the cervical cancer includes a clinical~     examination and a pelvic MRI in order to look for pelvic and para-aortic lymph nodes and to~     precise the volume and the spreading of the tumour in the pelvic area.~      A meta-analysis estimating the interest of the MRI showed a variable sensitivity and a~     specificity for the detection of such lymph node metastasis with a sensitivity varying from~     24 to 75 % and a specificity between 84 and 100 % according to the studies.~      As for the use of an 18-FDG PET scan to detect lymph node involvement, the studies realized~     so far are performed, usually, on a small number of subjects and with heterogeneous~     populations. However, it seems that such an examination enables a better detection of lymph~     nodes than the MRI does, especially for para-aortic lymph nodes depending on the studies,~     sensitivity varies from 57 to 100 %, and specificity between 92 and 100 %.~      We propose a prospective, multicentric and multidisciplinary study for the estimation of~     diagnosis methods. The main aim is to estimate the interest of the 18-FDG PET scan for the~     detection of pelvic and para-aortic lymph node metastasis in patients with cervical cancer,~     in comparison with the MRI. This study should enable to include 380 patients within 3 years.~     An 18-FDG scintigraphy will be performed before any treatment together with an MRI. A~     comparison between the sensitivity and the specificity of both examinations will be~     established and a correlation with the histology of the lymph node dissection will be made.~   "
256012|NCT00199667|"~     Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and~     tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and~     then minimize side effects in the long term. However definitive proof is still lacking. We~     conducted a randomized study in 11 french centers and included 137 kidney transplant~     recipients (PRA<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa,~     MMF and steroids. The fixed dose group received 2 g of MMF a day. The concentration~     controlled group received MMF dose adapted to the area under the concentration curve (AUC)~     of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a~     Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6~     , 12 in both groups (values note communicated to the physicians in the fixed dose group.~   "
256013|NCT00199654|"~     The follow up of colorectal cancer after curative surgery has to find loco-regional relapses~     or synchronous metastases, and to detect adenomas and new cancer on the rest of the colon.~      The increase of survival after relapse of the colorectal cancer depends on the possibility of~     curative action or after chemotherapy response.~      This is a Phase III open-labeled, multicenter, multidisciplinary, randomised study, comparing~     2 arms of 188 patients (i.e. 376 total patients).~      Study Period (date of first inclusion/last inclusion): 3 years.~      Follow Up: 3 years.~      The primary objective is the evaluation of PET performance in the earlier relapse detection~     of the colorectal cancer relapse in comparison with conventional control (including~     carcinoembryonic [CEA] levels and other classic radiological exams).~   "
256014|NCT00199641|"~     The aim of this study is to compare two strategies of early enteral nutrition in terms of~     efficacy and complications in mechanically ventilated patients.~   "
256015|NCT00199628|"~     Problems of compatibility between a mother and her child are frequent. The most well-known~     case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which~     can induce severe anemia of the fetus.~      The investigators recently proved that incompatibility between mother and child can concern~     an organ leading to a tissular alloimmunization. For example, neonatal membranous~     glomerulonephritis (a kidney disease) can result from this mechanism.~      The purpose of this network is to detect and study neonatal diseases induced by tissular~     fetomaternal alloimmunization. The detection of these diseases will be performed by the~     mother's serum analysis.~   "
256016|NCT00199615|"~     The guidelines and institutional practices recommended more frequent visits the two years~     following curative-intent therapy for non-small cell lung cancer (NSCLC).No international~     consensus is published concerning follow-up of resected NSCLC patients.Recent studies have~     outlined that positron emission tomography (PET) scanning may be accurate in early detection~     of recurrences by comparison to computed tomography (CT). The aim of this study is to compare~     follow-up by conventional methods versus PET. Patients are randomly assigned to two arms. In~     the first arm, thorax CT with liver and adrenal gland sections, abdominal ultrasonography and~     nuclear bone scintigraphy are performed every 6 months after surgery for two years. In the~     second arm, PET scanning is only. For brain metastasis detection, CT is performed in the two~     arms. Recurrences are detected during scheduled or unscheduled procedure in asymptomatic~     patients. PET and CT are interpreted separately by two nuclear physicians and two~     radiologists. The direct cost of follow-up procedure is determined in the two groups. The~     calculated sample is composed of 60 patients in each arm to detect significant difference.~     The Ethics Committee of Universitary Hospital of Limoges approves the study.~   "
256017|NCT00199602|"~     This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative~     3-arms of 140 patients (i.e. 420 total patients).~      Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months~   "
256018|NCT00199589|"~     This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with~     or without selective injection of BTA (Botox).~   "
256019|NCT00199576|"~     Tracheal intubation is a frequent procedure in intensive care units (ICU). Post-extubation~     laryngeal edema is a frequent complication with potential morbidity and mortality, and may~     lead to urgent tracheal re-intubation. Corticosteroids have been proposed to reduce the~     incidence of post-extubation laryngeal edema. A few clinical studies have been conducted in~     adult ICU patients and have led to discrepant results. These discrepancies may be related to~     the time lag separating the administration of the corticosteroids and the planned extubation.~     Accordingly, we tested the hypothesis that pretreatment with corticosteroids initiated 12~     hours before a planned extubation may efficiently prevent the occurrence of postextubation~     laryngeal edema in critically-ill adults who have been mechanically ventilated for more than~     36 hours in the ICU.~   "
256020|NCT00199563|"~     -  To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and~          without proven endothelial dysfunction and coexisting erectile concerns.~        -  To determine if chronic sildenafil use compared to placebo positively impacts~          endothelial function among a cohort of diabetic mend with erectile dysfunction~        -  To assess the salvage rate of sildenafil - failures who demonstrate improved response~          rates over time with chronic use~        -  To assess if microalbuminuria predicts flow-mediated dilation (FMD) response~        -  To measure and identify if other patient specific characteristics predict for sildenafil~          erectile response and flow-mediated dilatation (FMD) response over time (patient~          specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)~   "
256021|NCT00199550|"~     This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral~     prostatectomy) in men with symptomatic benign prostatic hyperplasia.~   "
256022|NCT00199537|"~     Patients with advanced prostate cancer undergoing adjuvant treatment with androgen blockade~     will be followed over a 1 year interval to assess the effects of this treatment on bone~     metabolism. It is expected that men undergoing androgen blockade will experience accelerated~     bone loss.~   "
256023|NCT00199524|"~     Patients with upper ureteral or renal stones will be randomized to undergoing ureteroscopy~     with or without a ureteral access sheath. The sheath is designed to facilitate ureteroscope~     insertion and re-insertion, thus allowing fragments to be basketed out. Stone free rates at 3~     months will be determined between the two groups.~      The investigators hypothesize that the use of the ureteral access sheath with ureteroscopy~     will result in improved stone free rates at 3 months compared to ureteroscopy without use of~     a sheath.~   "
256026|NCT00199485|"~     Men undergoing androgen deprivation therapy for prostate cancer may experience significant~     side effects including symptoms of intense heat, facial flushing, and sweating. These~     so-called hot flashes are similar to those experienced by women during menopause. A~     traditional Chinese herbal preparation, Dong Quai, has been used for thousands of years to~     reduce the incidence and severity of hot flashes. Anecdotal evidence exists to support the~     use of Dong Quai in men treated with androgen deprivation therapy for prostate cancer.~      Recently, the awareness and use of herbal remedies and over-the-counter preparations for a~     number of different conditions have increased dramatically. This trial was, therefore,~     designed to determine if Dong Quai significantly reduces the incidence and severity of hot~     flashes in men following androgen deprivation therapy for prostate cancer.~   "
256027|NCT00199472|"~     Renal blood flow is inversely related to obstruction. We propose that this imaging will be as~     effective as the diuretic renogram in the functional diagnosis of obstruction. Furthermore,~     dynamic contrast CT scanning may also add anatomic information necessary for the surgical~     treatment.~   "
256028|NCT00199459|"~     Urinary protein levels are not routinely measured in stone patients while there is strong~     evidence that proteins play a role in the etiology of stones. The purpose of this study is to~     examine the urinary and serum proteins of stone formers compared to healthy subjects~     utilizing the high throughput method, Surface Enhanced Laser Desorption/Ionization (SELDI).~     We hypothesize that there is a unique set of proteins expressed in serum and urine in stone~     patients that can be detected by SELDI. Ultimately, this will better our understanding of~     stone disease and help develop new prevention strategies.~   "
256029|NCT00199446|"~     The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40~     mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.~   "
256030|NCT00199433|"~     The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40~     mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.~   "
256031|NCT00199420|"~     To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the~     percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with~     levodopa.~   "
256032|NCT00199407|"~     To establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage~     of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.~   "
256033|NCT00199394|"~     The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline~     (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with~     advanced Parkinson's disease treated with levodopa.~   "
256034|NCT00199381|"~     This is an, open-label, long-term safety extension for patients in North America who have~     completed the prior istradefylline study 6002-INT-001.~   "
256035|NCT00199368|"~     This is a 1-year, open-label, long-term safety extension for patients who have completed~     prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.~   "
256036|NCT00199355|"~     To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the~     percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with~     levodopa.~   "
256037|NCT00199342|"~     This is a dose escalating cohort study to determine the maximum tolerated dose (MTD) of~     KW-2871 (in dose cohorts of 60, 80, and 100 mg/m2) when administered with a specified~     premedication regimen (ranitidine, diphenhydramine, and dexamethasone). KW-2871 will be~     administered at 14-day intervals.~   "
256038|NCT00199329|"~     PCA morphine always introduces nausea and vomiting during the postoperative period.~     Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen~     University, are trying to add ondansetron in PCA morphine. Patients receive a small dose of~     ondansetron when they request morphine.~   "
256039|NCT00199316|"~     postoperative pain after kidney surgery is very high. We always use PCA for postopertive~     pain. But almost patients still had severe pain. We try to use spinal morphine before~     operation aims to reduce pain.~   "
256040|NCT00199303|"~     We studied the effect of dextromethorphan (DEX), an N-methyl-d-aspartate antagonist, on~     analgesic consumption and pain scoring after abdominal hysterectomy. Our aim was to compare~     the analgesic effectiveness and incidence of adverse side effects of oral DEX with placebo~     (P)~   "
256041|NCT00199290|"~     This study is designed to evaluate the efficacy and the safety of Trafermin(recombinant human~     basic fibroblast growth factor: rhbFGF) in Japanese patients with marginal periodontitis, in~     order to verify the superiority of Trafermin to placebo, and to determine the recommended~     therapeutic dose.~   "
256042|NCT00199277|"~     The main objective of this study is to evaluate the efficacy of intravenous iron sucrose in~     increasing preoperative haemoglobin values in patients with colo-rectal neoplasm and iron~     deficiency anemia, compared to the standard treatment with oral iron. It will also determine~     whether intravenous iron sucrose administration improves outcomes such as postoperative~     haemoglobin values, serum ferritin values, transfusional needs, postoperative complications,~     or length of hospital stay.~   "
256043|NCT00199264|"~     To compare the therapeutic efficacy of 10 mg, 40 mg, 80 mg, 160 mg and 320 mg of~     albaconazole, as a single oral dose, in women affected by acute non-complicated~     vulvovaginitis due to Candida spp.~   "
256044|NCT00199251|"~     · To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over~     four-week treatment period in comparison with placebo.~   "
256045|NCT00199238|"~     The objective of this study is to evaluate the efficacy and safety of rupatadine for the~     treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine~     fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms.~   "
256046|NCT00199225|"~     This phase I trial will evaluate the effects of rupatadine, at a dose of 10 mg OD (authorised~     and marketed dose) and the 100mg/day (supratherapeutic dose) on the ECG parameters with a~     special focus on its effect on cardiac repolarisation (QTc interval duration).Furthermore,~     the study is performed to assess the pharmacokinetic-pharmacodynamic relationship between~     plasma concentration of rupatadine and its effects, if any, on cardiac repolarisation mainly~     in the QTc interval).~      The main objective is to assess whether administration of a repeated dose of 10 and 100~     mg/day , has the potential to cause QT prolongation in healthy volunteers.~   "
256051|NCT00199147|"~     Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine,~     Idarubicin and Etoposide (IdAV) given in parallel with (G-CSF priming) and followed by G-CSF~     versus the same IdAV chemotherapy only followed by G-CSF (without priming) in elderly~     patients with de novo AML, secondary AML and advanced MDS. Moreover, the ability to mobilize~     sufficient numbers of peripheral blood stem cells (PBSC) for autologous PBSC transplantation~     after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be~     evaluated.~   "
256052|NCT00199134|"~     Find a genetic signature of de novo resistance to letrozole in adjuvant breast cancer;~   "
256053|NCT00199121|"~     The purpose of this study is to evaluate the antiviral effect and durability of antiviral~     response (HIV-1 RNA PCR) and safety of a triple NtRTI/NsRTI therapy in antiretroviral naive~     patients. Patients will receive TDF plus FTC plus AZT for at least 48 weeks. Further~     objectives are to evaluate resistance pathways in failing patients treated with TDF/FTC/AZT~     and to evaluate a treatment strategy of sparing PIs and NNRTIs for later treatment.~   "
256054|NCT00199108|"~     Patients with acute lymphoblastic leukaemia or very aggressive lymphoma and documented~     isolated CNS relapse or CNS relapse combined with other relapse sites should receive therapy~     with intrathecal DepoCyte at least once. Treatment may be repeated during induction phase~     each 2 weeks and monthly during maintenance phase. The study aim is to replace the usual 2-3~     weekly applications of intrathecal triple therapy with one application of DepoCyte. Primary~     objective is the response rate after one application of DepoCyte. Further objectives are the~     compilation of data regarding safety and toxicity~   "
256055|NCT00199095|"~     The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in~     elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of~     induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance~     therapy~   "
256056|NCT00199082|"~     The study evaluates the efficacy and tolerability of alternating short cycles of high-dose~     and conventional chemotherapy in combination with rituximab in CD20 positive patients,~     followed by local radiation therapy in the case of initial mediastinal or central nervous~     system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is~     offered for patients estimated to be over 55 years, biologically.~   "
256057|NCT00199069|"~     The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy~     over one year, followed by randomized either intensified or conventional maintenance therapy.~     It includes a distinct protocol for the subgroup 'mature B-ALL',~   "
256058|NCT00199056|"~     The study evaluates the efficacy and tolerability of an intensified induction and~     consolidation therapy. Thereafter patients receive individualised treatment stratified~     according to relapse risk with stem cell transplantation for patients with high and very high~     risk of relapse. Patients with standard risk receive further consolidation and reinduction~     chemotherapy. In parallel minimal residual disease (MRD) is evaluated. A MRD based risk~     stratification and treatment decision is developed.~   "
256059|NCT00199043|"~     In this study the efficacy and tolerability of two approaches to treat and prevent~     hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma~     with high risk of tumor lysis syndrome. Both arms are compared by randomisation. In one arm~     patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol~     whereas in the other arm Rasburicase is used.~   "
256060|NCT00199030|"~     This study tests the effectivity and tolerability of treatment with alemtuzumab (MabCampath)~     in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or~     T-lymphoblastic lymphoma. In Arm A, patients with refractory relapse receive a 2 week~     treatment with MabCampath followed by remission evaluation. In case of insufficient response,~     treatment with cladribine is added. In Arm B, patients with molecular relapse (minimal~     residual disease) receive a 4 week treatment with MabCampath followed by remission~     evaluation. In both arms, treatment is continued in case of response for up to two months.~   "
256061|NCT00199017|"~     This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma~     (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year~     of intensive cyclical chemotherapy with additional prophylaxis for central nervous system~     (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation~     after induction chemotherapy.~   "
256062|NCT00199004|"~     The study evaluates the efficacy and tolerability of an intensified induction and~     consolidation therapy in combination with rituximab in CD20 positive standard risk patients.~     Thereafter patients receive additional consolidation and reinduction cycles combined with~     rituximab. In parallel minimal residual disease is evaluated. After six months and one year~     the decision on intensification or discontinuation of therapy is made based on results of MRD~     evaluation~   "
256063|NCT00198991|"~     The study evaluates the efficacy and tolerability of an intensified induction and~     consolidation therapy. Thereafter patients receive individualised treatment stratified~     according to relapse risk with stem cell transplantation for patients with high and very high~     risk of relapse. Patients with standard risk receive further consolidation and reinduction~     chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and~     one year the decision on intensification or discontinuation of therapy is made based on the~     results of MRD evaluation.~   "
256064|NCT00198978|"~     The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the~     treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression~     of CD20 on leukemic cells the efficacy and tolerability of additional application of~     Rituximab together with chemotherapy is evaluated.~   "
256083|NCT00198731|"~     Maternal death is a substantial burden in developing countries. In Bangladesh, recent studies~     have suggested that a large proportion of women giving birth in rural areas experience~     pregnancy and delivery related complications. This study, which is set in context where~     home-birth is the norm, provides the opportunity to provide descriptive information on the~     self-reported prevalence of maternal behaviors and morbidities during pregnancy, delivery and~     postpartum periods and to quantify the effects of provision of maternal care interventions~     through trained community health workers on a few selected maternal behaviors and~     morbidities.~   "
256065|NCT00198965|"~     This study will be conducted over three phases. Phase I will be a 16-week weight lass phase.~     Phase II will be a 52-week maintenance phase. Phase III will be a follow-up phase. We will~     test three diet regimens: 1) an olestra group who will receive a weight-reducing diet that~     includes olestra-containing products; 2) a triglyceride group who will receive the same~     weight-reducing diet but with foods made with triglyceride (regular fat); 3) a low-fat group~     will be instructed to consume a diet made of traditionally low-fat foods that ate available~     in grocery stores (no olestra foods). These groups will be re-randomized for the maintenance~     phase and again assigned to one of the three weight loss regimens described above: olestra,~     triglyceride, or low-fat. In the double-blinded experimental design, groups receiving olestra~     foods will not be informed of the nutrient contents of the foods or told what fat substitute~     is used in the preparation. (The consent form will state that a new fat-substitute may be~     used in the study foods.) During a “run-in” phase, olestra versus regular-fat food sensory~     and tolerance tests will be conducted.~   "
256066|NCT00198952|"~     to test safety and efficacy on metabolism, heart rate, blood pressure, TSH (and other~     blood)and hunger/caloric compensation on ephedra versus placebo~   "
256067|NCT00198939|"~     In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug~     abuse prevention intervention for indicated middle school youth that coordinates family and~     teen-based components. The Family Management Intervention is comprised of a parent-focused~     curriculum to foster parenting skills followed by brief family therapy to foster adaptive~     family communication and age-appropriate roles. The Teen Achievement Intervention is~     comprised of a clinician-delivered learning strategy curriculum to foster academic~     achievement followed by a similar yet peer-facilitated curriculum to foster self-efficacy and~     prosocial peer networks. In the first study aim, we seek to evaluate the separate and~     possibly synergistic effects of the Family Management and Teen Achievement components on post~     intervention drug use, problem behavior, psychological distress, and academic achievement of~     indicated youth. Innovative analytic strategies are subsequently used to elucidate mediated~     pathways by which the interventions might reduce drug involvement and problem behavior by~     promoting changes in targeted skills and behavior change processes. The possibility of~     effect-modification also is considered, with a focus on neurocognitive,~     internalizing/externalizing, and demographic factors, in an effort to discern why~     interventions work for some youth but not others. This application revision has sought to~     address well-taken concerns cited by the reviewers while maintaining proposal strengths. In~     response to a key limitation, this revision includes further specification of anticipated~     relationships between neurocognitive variables, skill acquisition levels, and prevention~     intervention outcomes among indicated youth. Study hypotheses on specific neurocognitive~     effects are informed by empirical findings and the clinical experience of investigative team~     members specializing in neuropsychology. If successful, this project should improve~     prevention practices by identifying malleable behavior change processes fostered by effective~     interventions. Improving our understanding of how individual characteristics of indicated~     youth, such as neurocognitive deficits or externalizing problems, influence the development~     of skills during interventions and subsequent outcomes may also help to improve existing~     prevention interventions. The significance of the proposed study is underscored further by~     the substantial size of the targeted population of indicated youth, and the range of~     morbidities and mortality that often result when early warning signs of drug abuse are not~     addressed.~   "
256068|NCT00198926|"~     A short-term feeding study in type 2 diabetics manipulating the fat and caloric values of~     meals to assess both compensation and glucose control, both covertly and overtly.~   "
256069|NCT00198913|"~     Part 1 of this research demonstrated that type II diabetics are lacking in knowledge of how~     to best treat their illness with dietary controls. Most had little nutrition or diabetes~     knowledge. Part 2 demonstrated that providing a 40% reduction in fat intake across three~     meals versus all at one meal was more effective in glycemic control. Part 3 is designed to~     incorporate these findings into a long-term free living setting through education and~     behavior/dietary modification.~   "
256070|NCT00198900|"~     To assess the knowledge of both type 2 diabetics and non-diabetics on diabetes, nutrition,~     and exercise. Although type 2 diabetics should know more about their disease and its needs,~     it is not expected they will know significantly more than the lay public.~   "
256071|NCT00198887|"~     This study is designed to look at how operations are carried out in relation to improving the~     health and survival of newborn babies in India.~   "
256072|NCT00198874|"~     This Stage II study is in response to NIDA's Behavioral Therapies Development Program~     (PA-99-107). A randomized clinical trial is proposed to evaluate the direct, mediated, and~     moderated effects of Integrated Family and Cognitive-Behavioral Therapy (IFCBT), a~     multisystems treatment for adolescent drug abuse with promising efficacy results. In the~     first study aim, we seek to evaluate the separate and possibly synergistic effects of family~     systems and cognitive-behavioral IFCBT components on posttreatment drug abuse problem~     severity, problem behavior, psychiatric distress, and academic achievement of adolescent drug~     abusers. Innovative analytic strategies are subsequently used to evaluate the degree to which~     successful outcomes are attributable to specific familial and cognitive-behavioral change~     processes targeted by IFCBT components. The possibility of effect-modification also is~     considered, with a focus on neurocognitive, psychiatric comorbidity, and demographic factors.~     Namely, we seek to understand how variations in specific client characteristics, such as~     executive dysfunctions or psychiatric comorbidity, might explain why treatments work for some~     drug abusing youths but not others. In addition to promising findings on IFCBT efficacy, this~     Stage II proposal benefits from the development and Stage I study application of (a)~     treatment manuals; (b) therapist training procedures; (c) therapist adherence and competence~     tools; (d) a neuropsychological battery to assess cognitive functions; (e) a psychodiagnostic~     battery to assess comorbid psychiatric disorders; and (f) a study assessment battery~     comprised of therapeutic process and outcome measures. This revised application has sought to~     address well-taken concerns cited by the reviewers while maintaining proposal strengths. The~     lack of adolescent drug treatment research continues to be a serious gap in the addictions~     literature despite alarmingly high rates of drug abuse among youth and the range of~     morbidities and mortality that result nationwide. If successful, this project should help to~     identify specific behavior change processes targeted by family systems and~     cognitive-behavioral treatments that foster subsequent reductions in drug use and problem~     behavior among recovering youth. Neurocognitive and psychiatric influences on adolescent drug~     treatment outcomes appear to be significant yet are poorly understood. Increasing our~     understanding of relationships between client characteristics, skill development during~     treatments, and subsequent outcomes should also help to improve adolescent drug treatments.~   "
256084|NCT00198718|"~     The ZVITAMBO PROJECT is testing whether giving mothers and infants a single large dose of~     vitamin A during the immediate post partum period will reduce:~        1. Infant Mortality Can oral administration of a single 50,000 IU dose of vitamin A to~          newborn infants, a single 400,000 IU dose of vitamin A given to their lactating mothers,~          or supplementation of both the mother and infant during the immediate post partum period~          reduce infant mortality by at least 30%?~        2. Mother to Child HIV transmission during breast feeding Can oral administration of a~          single large dose of vitamin A given during the immediate post partum period to HIV~          seropositive lactating women and/or their babies reduce HIV transmission via breast~          feeding by at least 30%?~        3. Sexually transmitted HIV infection of post partum women Can a single 400,000 IU dose of~          vitamin A given during the immediate post partum period to HIV seronegative women reduce~          their likelihood of becoming HIV infected during the post partum year by at least 25%?~        4. Infant feeding in the context of HIV: An operational research study was initiated~          mid-way through the trial to determine how UNAIDS Guidelines on infant feeding in the~          context of HIV could be effectively implemented and to measure the impact of such a~          program on infant feeding practices and postnatal HIV transmission.~      Substudies:~      Random subsamples of maternal and infant blood were evaluated for anemia and iron status to~     determine the effect of vitamin A on hematopoiesis and serum and breast milk retinol~     (mothers) and modified relative dose response test (infants) to determine the effect of~     vitamin A on vitamin A status.~      A subsample of maternal and infant blood samples were evaluated for the presence of HLA-E,~     HLA-G, and TAP polymorphisms and their relation to prevalent HIV infection in mothers and~     risk of mother to child transmission.~   "
256085|NCT00198705|"~     This project delivers, promotes and facilitates services related to pregnancy, delivery and~     newborn care.~   "
256073|NCT00198861|"~     The purpose of this R01 study is to evaluate the association between neuropsychological~     executive dysfunction and HIV infection among young injection and non-injection drug users. A~     longitudinal study will be conducted in which the cohort of seronegative drug users~     completing a baseline neuropsychological battery are re-assessed on three subsequent~     occasions, roughly six months apart. The primary aim of the longitudinal study is to estimate~     the magnitude of the suspected causal relationship between executive dysfunction and HIV-risk~     behaviors while adjusting for time-invariant (e.g. sex, ethnicity) and time-varying (e.g.~     degree of drug abuse) covariates. We also seek to evaluate: (1) the degree to which specific~     executive dysfunctions predispose heroin and cocaine users to high-risk injection practices~     or sex behaviors, and (2) whether observed relationship between executive dysfunction and~     HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or~     whether the observed data are more consistent with complex patterns of interdependency~     between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors. If successful,~     this project will shed new light on significant and potentially malleable HIV-risk factors in~     injection and non-injection drug users. This will be important evidence because injection~     drug abuse continues to account for a large proportion of HIV seroconversions particularly~     among young women and minorities. As such, this RO1 research project serves as an important~     initial step in a line of innovative investigations about suspected causal associations~     between neuropsychological deficits and HIV-risk behaviors in drug users. Ultimately, this~     line of investigation should lead to changes in public and clinical practices designed to~     prevent HIV infection.~   "
256074|NCT00198848|"~     This study will implement and evaluate a community-based intervention to distribute and~     promote consumption of weekly iron-folic acid supplements and to provide nutrition education~     to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal,~     India.~   "
256075|NCT00198835|"~     This study is designed to evaluate the effectiveness of CARE India's Integrated Nutrition and~     Health Program (INHP II) to reduce malnutrition among children 0-23 months of age.~   "
256076|NCT00198822|"~     The purpose of this trial is to determine whether providing women with a weekly oral~     supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a~     recommended intake from early pregnancy through three months postpartum, can reduce the risk~     of maternal mortality, fetal loss, or infant mortality.~   "
256077|NCT00198809|"~     Effects of herbal products on weight loss, weight maintenance and metabolic rate.~        -  The objective of this study is to evaluate the efficacy of two herbal weight loss~          products, BioLean and BioLean Free compared to each other and a matching placebo, in~          effects on appetite suppression, changes in metabolism, weight loss, and safety in~          overweight men and women over a 12 month active weight loss and weight maintenance~          program.~        -  This is a randomized double-blind study. The planned sample size is 180 healthy,~          overweight (BMI 27-40) males and females aged 18-60.~   "
256078|NCT00198796|"~     Five subjects will be admitted to the General Clinical Research Center (GCRC). The next day~     they will eat a light breakfast, fast for 90 minutes, ingest ETEC strain H10407, and fast for~     90 more minutes. After this challenge they will be monitored closely , and all stools will be~     collected, graded and weighed. On Day 5, or sooner if indicated, they will begin antibiotics~     to eradicate the challenge strain. They will be scheduled for discharge on Day 7 but may~     leave a few days earlier if early antibiotic treatment is given.~      Hypothesis:~      A challenge dose of 10(9) colony forming unit (CFU) of ETEC strain H10407, will cause~     diarrhea in at least 60% of subjects.~   "
256079|NCT00198783|"~     The objective of this study will assess the feasibility of utilizing real-time data~     monitoring in future clinical trials of weight control medications and other treatment~     modalities, along with the feasibility of distinguishing different types of relapses over 16~     weeks: There will be 4 weeks of high-intensity EMA and 12 weeks of low-intensity EMA. Each~     participant will be in the study for 52 weeks with 20 visits, including follow-up visits.~   "
256080|NCT00198770|"~     Unfortunately, current methods of achieving weight control are disappointing. There is also a~     great deal of public confusion over what constitutes an appropriate diet for weight control;~     there is a paucity of carefully performed, randomized, controlled clinical treatment trials~     to evaluate the varying opinions. Mushrooms are not widely appreciated as the nutritious, low~     calorie, low fat food (and potential meat substitute) that they are. Mushrooms may be a new~     diet food, especially as a substitute for higher calorie and fat staples like meat.~      This study examines whether there is compensation for the potential calorie and fat savings~     of substituting mushrooms for meat in dishes over a 4-day period.~   "
256081|NCT00198757|"~     The objective of this study is to evaluate the efficacy of Medifast Plus for Diabetics~     compared to a standard weight loss treatment program, in terms of changes in weight loss in~     overweight men and women over an 86 week active weight loss and weight maintenance program.~     There will be up to 34 weeks active weight loss and 52 weeks weight maintenance. The planned~     sample size is 80 overweight (BMI 25-40) males and females aged 18-65 with type 2 diabetes.~     It is anticipated that pre-packaged meal replacements will provide an advantage to those~     desiring weight loss.~   "
256082|NCT00198744|"~     1. Does a joint parent-child dieting approach, as opposed to an individually-based~          approach, improve weight loss outcomes?~        2. Is a diet which includes Medifast meal replacements as efficacious as a non-supplemented~          Food Guide Pyramid-based diet (reference diet) in achieving better adherence to the~          diet, initial weight loss, reduction in % body fat, and weight maintenance?~        3. Does regular use of Medifast meal replacements, in conjunction with a Food Guide~          Pyramid-based diet, result in significantly better compliance, greater dietary~          satisfaction, dietary quality, and palatability than the reference diet?~        4. Do children who have lost weight using Medifast meal replacements, as an adjunct to a~          Food Guide Pyramid-based diet, achieve health benefits compared to baseline values and~          are these health benefits greater than those obtained following the reference diet?~   "
256086|NCT00198692|"~     The specific aims of this study are:~        1. To develop and pilot a self-management (SM) intervention for persons with limb loss in a~          group setting using a participatory action research (PAR) strategy.~        2. To evaluate the feasiablity and effectiveness of a SM intervention within the context of~          the existng network of limb loss peer support groups~           Hypothesis #2a: The SM intervention groups will be more effective than standard support~          group activities in reducing pain, depression and anxiety, and increasing positive mood~          and improving function and overall quality of life.~           Hypothesis #2b: Improvements in pain, depression, anxiety, function and quality of life~          will correlate strongly with improvements in self-efficacy, catastrophizing, and~          satisfaction with the prosthesis and prosthetic services.~           Hypothesis #2c: Gains in outcome will be maintained for one year.~           Hypothesis #2d: Characteristics of study participants and their environment (i.e.~          sociodemographics, co-morbidities, economic and educational resources, hope, and social~          support) will correlate with outcome and mediate the effect of the intervention.~        3. To determine the costs of the intervention and examine the relationship between costs~          and effectiveness.~      Hypothesis #3a: When compared to the control support group, the SM intervention will be~     cost-effective in terms of gains in quality adjusted years of life.~   "
256087|NCT00198679|"~     Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and~     cost-effective intervention for reducing neonatal death in developing country settings, this~     study follows a trial already underway in Nepal to test the impact of a single cleansing of~     the skin with baby wipes cotaining chlorahexidine.~   "
256088|NCT00198666|"~     This study is designed to evaluate the efficacy of zinc supplementation in the treatment of~     children under the age of two years who have been hospitalized with severe pneumonia.~   "
256089|NCT00198653|"~     The purpose of this study is to train mothers/caretakers on how to prevent their babies from~     becoming too cold.~   "
256090|NCT00198640|"~     This study looks at the usage of human antibiotics for treatment of animals in Bangladesh.~   "
256091|NCT00198627|"~     The purpose of this study is to determine what are the major types of bacteria that cause~     newborn infections in the community in rural Bangladesh and whether providing an obstetric~     and neonatal care package will reduce neonatal deaths by 40%.~   "
256092|NCT00198614|"~     Postoperative new-onset atrial fibrillation (AF) is the most common complication stemming~     from coronary artery bypass graft surgery, and is associated with increased early and late~     mortality risk. Standard guidelines recommend β blockers for the prevention of AF; however,~     no prospective study has compared the relative efficacy of β-blocking agents. We hypothesize~     that carvedilol, a non-selective adrenergic blocker with both anti-inflammatory and~     antioxidant properties, is more effective than metoprolol, a conventional β1-selective~     antagonist, in suppressing new-onset AF following off-pump coronary bypass surgery. We have~     designed the Carvedilol or Metoprolol Post-Revascularization Atrial Fibrillation Controlled~     Trial (COMPACT) to test our hypothesis in a multi-center, open-label, and randomized~     controlled trial.~   "
256093|NCT00198601|"~     The purpose of this study is to determine what dosage of gentamicin for use in one-time~     administration device (Uniject) is appropriate.~   "
256094|NCT00198588|"~     The purpose of the study is to evaluate efficacy and safety of argatroban in the patients~     with heparin-induced thrombocytopenia (HIT)/ HIT and thrombosis syndrome (HITTS). This~     multi-center trial covers mainly the patients with cardiovascular diseases. Subjects are~     included in the trial when they are clinically diagnosed of HIT/HITTS. Initial dose of~     argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the US. The~     reason of the lower initial dose is that the approved dose of argatroban in Japan (for the~     treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug~     are not confirmed. A sub-study of pharmacokinetics is simultaneously conducted to reveal the~     relationship among the dose, aPTT, and blood drug concentration.~   "
256095|NCT00198575|"~     Several clinical studies in Western countries have revealed that the prevalence of HIT is 0.5~     to 5%, varying depending on the clinical setting. Thirty to 50% of HIT patients suffer from~     thromboembolic events, and the mortality of HIT is 10 to 20%. In contrast, many physicians in~     Japan report no experience in treating HIT, although approximately 200,000 patients per year~     receive heparin. This raises the possibility that the prevalence of HIT might be much lower~     in Japan than in Western countries. In fact, neither the drug for HIT treatment nor the~     laboratory test for HIT diagnosis has been approved by the Pharmaceutical Affairs Law in~     Japan. We have therefore conducted a multi-center, prospective cohort study to determine the~     prevalence and profile of HIT in patients undergoing cardiovascular surgery or percutaneous~     coronary intervention. Approximately 1,500 patients will be enrolled in this study.~   "
256096|NCT00198562|"~     The aim of this trial is to study the effects of antihypertensive therapy based on home~     systolic blood pressure (BP) with different target levels using two classes of drugs.~      The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. The~     study subjects are 40-79 years old hypertensive patients. After a 4 weeks of baseline period,~     subjects are randomly assigned to (1) modest control group (morning home BP <140 mmHg) or (2)~     strict control group (morning home BP <130 mmHg), and to (a) amlodipine group or (b) losartan~     group. Additional antihypertensive drugs can be used if home BP is not controlled. Home BP is~     measured in the early morning and late evening. The participants will be followed up for 5~     years.~   "
256097|NCT00198549|"~     The purpose of this study is to evaluate Vitrase as an adjuvant to increase absorption and~     dispersion of other injected anesthetics~   "
256098|NCT00198536|"~     The purpose of this study is to determine whether ecabet ophthalmic solution is an effective~     treatment for dry eye syndrome~   "
256099|NCT00198523|"~     The purpose of this study is to demonstrate the bioequivalence of the combination test agent,~     prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte~     (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by~     comparing aqueous humor concentrations of prednisolone acetate.~   "
256100|NCT00198510|"~     The purpose of this study is to determine if intravitreal injection of Vitrase (ovine~     hyaluronidase) clears vitreous hemorrhage~   "
256101|NCT00198497|"~     The purpose of this study is to determine if intravitreal injection of Vitrase (ovine~     hyaluronidase) clears vitreous hemorrhage~   "
258711|NCT00163631|"~     Investigate vasoactive medicators in portal hypertension on stored sera~   "
256102|NCT00198484|"~     The purpose of this study is to determine whether Vitrase (hyaluronidase for injection) is~     effective as a spreading agent for other injected drugs prior to ocular surgery~   "
256103|NCT00198471|"~     The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to~     induce posterior vitreous detachment(PVD) in subjects with moderate to severe~     non-proliferative diabetic retinopathy.~   "
256104|NCT00198458|"~     The objective of this study was to rule out a greater than 10% incidence of hypersensitivity~     to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or~     equal to a 10% hypersensitivity response was considered acceptable.~   "
256105|NCT00198445|"~     The primary objective of this study was to investigate the efficacy of bromfenac sodium~     ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who~     undergo cataract extraction and intraocular lens implantation. The secondary objective was to~     investigate the safety and tolerability of the same.~   "
256106|NCT00198432|"~     To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC~     stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a~     induction chemotherapy, or followed by a consolidation chemotherapy.~   "
256107|NCT00198419|"~     The objective of this study was to rule out a greater than 10% incidence of hypersensitivity~     to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or~     equal to 10% hypersensitivity response was considered acceptable.~   "
256108|NCT00198406|"~     Management of lung cancer remains very controversial for elderly patients (pts) and they are~     often excluded from clinical trials. We present here a survey performed about the management~     of lung cancer pts aged 70 or more in France. All pts aged 70 or more with~     histo/cytologically proved lung cancer diagnosed between sept 02 and oct 03 in participating~     centers were recorded and their characteristics, the diagnostic procedures, therapeutic~     management and survival were analysed.~   "
256109|NCT00198393|"~     Patients presenting a deterioration of the general state (performance status [PS] 2-3),~     constitute a population which needs an adapted treatment. An analysis was made of the~     evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594~     trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel,~     docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to~     the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end~     of this study, with the analysis of total toxicity, this one was not higher than that noted~     in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been~     noted, but the analysis showed that only 2 were due to the treatment. It was noted that the~     lower survival compared to the others was related to the disease and not to the treatment.~     These patients are often symptomatic and need palliative treatment. The benefit of~     chemotherapy should not be denied. They should profit from a monochemotherapy with the new~     cytotoxic agents, without associated platinum salt.~   "
256110|NCT00198380|"~     Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological~     pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and~     BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for~     resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced~     P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine~     kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid,~     dramatic responses, possibly reflecting specific molecular differences from other non-small~     cell lung carcinomas.~   "
256111|NCT00198367|"~     Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2~     account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the~     results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or~     radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests~     of exclusive CT, or in noncomparative tests of RT-CT.~   "
256112|NCT00198354|"~     The addition of chemotherapy to lung cancer surgery is now considered as the standard of~     care. Solid data support postoperative chemotherapy but only few results are available in the~     preoperative setting. To define which timing of perioperative chemotherapy offers the best~     survival improvement, the IFCT 0002 study is conducted in France.~   "
256113|NCT00198341|"~     The follow-up of patients operated on for lung cancer is heterogeneous. An intensive~     follow-up including routine clinic visits, chest X-rays, chest computed tomography (CT) scans~     and fiberoptic bronchoscopies might detect more small, potentially curable, recurrences and~     second cancers. However, as it appears in the American Society of Clinical Oncology (ASCO)~     recommendations, a large randomized study is necessary to evaluate the survival impact of~     such a follow-up strategy. This is the main objective of this IFCT-0302 study, which is a~     large randomized controlled study conducted in France comparing this intensive follow-up to a~     follow-up with only routine clinic visits and chest X-rays.~   "
256114|NCT00198328|"~     The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with~     regard to local tumor recurrence, disease-free survival, and overall survival rates versus~     surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the base of the~     tongue, posterior lateral pharyngeal wall, hypopharynx or larynx.~   "
256115|NCT00198315|"~     The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with~     regard to local tumor recurrence, disease-free survival, and overall survival rates versus~     surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the anterior oral~     cavity, soft palate, or tonsil.~   "
256116|NCT00198302|"~     Hospitalized patients at least 18 years of age, with Staphylococcus aureus bacteremia (SAB)~     will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day~     1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that~     is designed to combat Staphylococcus aureus.~      The purpose of this study is to assess the safety and pharmacokinetics of standard antibiotic~     therapy, plus Aurexis or Placebo for treatment of (SAB). Additionally, certain tests and~     measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit~     to these patients.~   "
256153|NCT00197808|"~     The purpose of the study is to evaluate the immune responses of UK infants after one or two~     doses of pneumococcal conjugate vaccine or one or two doses of three different types of~     meningococcal conjugate vaccine given at either two and three or two and four months of age.~   "
256117|NCT00198289|"~     Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus~     aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis®~     intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized~     monoclonal antibody that is designed to combat Staphylococcus aureus.~      The purpose of this study is to assess the safety and pharmacokinetic profile (concentration~     of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will~     be conducted to preliminarily determine if Aurexis demonstrates any benefit to these~     patients.~   "
256118|NCT00198276|"~     The purpose of the study is to study the safety and efficacy of MedPulser Electroporation~     with bleomycin treatment of cutaneous and subcutaneous foci of cancer.~   "
256119|NCT00198263|"~     The purpose of the trial is to study the safety and efficacy of the Medpulser Electroporation~     System with bleomycin in the treatment of head and neck cancer.~   "
256120|NCT00198250|"~     The purpose of this study is to evaluate Venlafaxine as a treatment option for hot flashes in~     breast cancer survivors. The goals of this study are to assess the effectiveness and toxicity~     of venlafaxine hydrochloride and identify the psychological, behavioral, and physical~     outcomes associated with relief of hot flashes in women following treatment for breast~     cancer.~   "
256121|NCT00198237|"~     The primary objective of this study is to determine the efficacy & toxicity of combined~     docetaxel & capecitabine as primary chemo for subjects w/ stage II-III breast cancer.~   "
256122|NCT00198224|"~     Valganciclovir (VGCV) has recently been approved by the Food and Drug Administration (FDA)~     for the treatment and prevention of cytomegalovirus (CMV) retinitis in HIV patients. It is~     under review for the prevention of CMV disease following organ transplantation. Mycophenolate~     mofetil (MMF), the morpholinoethyl ester of mycophenolic acid (MPA) is currently the most~     widespread used immunosuppressant in kidney transplantation. These drugs exerts their effects~     by blocking the production of DNA primarily in lymphocytes.~      Recent studies have suggested that combining both MMF and GCV in vitro may have a beneficial~     effect on the treatment of CMV infections. However, the effect of these two drugs in~     combination on the effects of the immune system both in vitro and in vivo have not been~     studied. Preliminary studies in our lab show that a combination of these two drugs have an~     additive effect on the level of immunosuppression of both the growth and differentiation of~     progenitor bone marrow cells as well as lymphocyte proliferation.~      This study is designed to test patients degree of immune reactivity both on and off VGCV when~     used in combination with MMF. Patients will have blood drawn as several time points and an~     immune assay will be performed to show if VGCV when used in combination with MMF exerts~     immunosuppressive effects.~   "
256123|NCT00198198|"~     This is a study of addition of aripirazole to the treatment of bipolar depressed patients who~     are not better on the medications that they are currently receiving.~   "
256124|NCT00198185|"~     Hypothesis: The use of cascade platelet-rich fibrin matrix (PRFM) on medium and large sized~     rotator cuff tears will improve patient results versus the control results by 50%.~      The purpose of this study is to examine the effect of PRFM on rotator cuff repairs. Since~     locally applied platelet-derived growth factor (PDGF) has shown early promise in enhancing~     tendon and ligament healing in anterior cruciate ligament (ACL) and medial collateral~     ligament (MCL) reconstruction, the investigators believe that locally applied PRFM will~     enhance the quality of rotator cuff repairs.~   "
256125|NCT00198172|"~     This study proposes to evaluate the combination of cisplatin plus epirubicin in patients with~     refractory germ cell tumor not amendable to cure with surgery or standard platinum salvage~     chemotherapy. This regimen will be used in eligible patients after progression on ECOG Study~     E39897.~   "
256126|NCT00198159|"~     This study will evaluate the use of ZD1839 in the treatment of subjects with refractory germ~     cell tumors. Subjects will take ZD1839 for one year in the absence of excessive toxicity or~     decision to withdraw.~   "
256127|NCT00198146|"~     The primary purpose of this study is to determine the efficacy and safety of daclizumab in~     preventing the progression of diabetes in children who have just been diagnosed with type I~     diabetes. Additional purposes of the study are to investigate the amount of drug in the~     children, how quickly it is eliminated from the blood, and analyze the effect of the drug on~     the immune reaction to diabetes.~   "
256128|NCT00198133|"~     To study the efficacy of Alimta as a single agent in thymic cancers~   "
256129|NCT00198120|"~     This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism~     in autistic children.~   "
256130|NCT00198107|"~     This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating~     symptoms associated with autism in children.~   "
256131|NCT00198094|"~     The primary objective for the study is to test the hypothesis that sertraline plus alprazolam~     XR will result in superior early stabilization of primary care PD patients versus~     sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are~     a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial)~     and after discontinuation, b) to compare physical health outcomes, medical services~     utilization, and cost-effectiveness of the two study interventions across the 12-week~     treatment period and subsequent three month maintenance treatment with sertraline alone, and~     c) to assess whether early co-administration of sertraline/ alprazolam XR will result in~     greater maintenance of treatment response than sertraline/placebo over the three months~     following the 12 week acute treatment program.~   "
256132|NCT00198081|"~     The purpose of the study is to find out whether the drug celecoxib has beneficial effects on~     people with pre-cancerous lesions of the pancreas.~   "
256133|NCT00198068|"~     The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major~     clinical centers. The purpose of the study is 1) to determine whether certain proteins~     (called complement split products) that can injure healthy organs can be used to predict poor~     pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid~     syndrome (APS), and/or 2) to determine whether elevated levels of circulating antiangiogenic~     factors predict pregnancy complications in patients with aPL antibodies and/or SLE.~   "
256154|NCT00197795|"~     To measure the serum bactericidal antibody levels and cell mediated immune responses before~     and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6~     and 12 weeks to healthy UK adults.~   "
271398|NCT00032942|"~     The purpose of this study is to evaluate lofexidine for opiate withdrawal.~   "
256134|NCT00198055|"~     The purpose of this study is to develop a better tolerated and more effective pharmacologic~     treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This~     is an open-label investigation of aripiprazole in the management of the maladaptive behaviors~     of autistic disorder. We hypothesize that aripiprazole will be effective for reducing~     aggression and repetitive behavior.~   "
256135|NCT00198042|"~     Hypothesis 1: There is less tunnel-widening with bone-patella tendon-bone graft compared with~     the hamstring graft when the same fixation method is used. Tunnel widening is greater with~     achilles tendon allografts versus autograft bone-patella tendon-bone and hamstring~     autografts.~      Hypothesis 2: Tunnel widening occurs in the early post-operative period (< 8 weeks) when the~     tendon remodels within the bone tunnels.~      Hypothesis 3: Low pre-operative bone mineral density is associated with tunnel widening.~   "
256136|NCT00198029|"~     The purpose of this study is to find out if hyaluronan, an injectable medication for knee~     arthritis, also works for arthritis at the base of the thumb. This study will also evaluate~     how good ultrasound is at visualizing medication in the thumb joint. We are no longer~     recruiting for this part of the open label trial.~   "
256137|NCT00198016|"~     Background and Purpose: Congenital coronary artery fistula (CAF) is an uncommon anomaly. In~     some patients they can became symptomatic, associated with significant morbidity and~     mortality. We report our experience in percutaneous treatment of CAF.~   "
256138|NCT00198003|"~     The goals of this study are to develop and test an educational intervention to address~     patients' expectations of long-term outcomes of total hip arthroplasty.~   "
256139|NCT00197990|"~     The goals of this study are to identify predictors of improvement in quality of life and~     satisfaction with total hip arthroplasty three to five years after surgery.~   "
256140|NCT00197977|"~     The goals of this study are to develop and test an educational intervention to address~     patients' expectations of long-term outcomes of total knee arthroplasty.~   "
256141|NCT00197964|"~     Among 180 patients with moderate asthma, the specific aim of this randomized trial is to~     assess the effectiveness of an intervention involving education, enhancement of~     self-efficacy, and asthma social support in preventing deterioration in functional status~     over two years.~   "
256142|NCT00197951|"~     Alcohol dependent patients show comorbid psychiatric symptoms, related to malfunction of~     dopamine, norepinephrine and serotonin neurotransmission, during early recovery. Ziprasidone~     can improve malfunctioning of these disregulated systems, thereby improving anxiety,~     depression, anhedonia, anger, and alcohol craving.~   "
256143|NCT00197938|"~     Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of~     oxygen. This leads to increased formation of lactic acid.~      The investigators hypothesize, that the more serious the condition, the higher the~     concentration of lactic acid will be, thus relating to the risk of multiple organ failure or~     death.~   "
256144|NCT00197925|"~     The study aim to show if vaccination with autologous dendritic cells pulsed with~     onco-peptides in combination with adjuvant cytokine can induce a measurable immune response~     in patients with metastatic breast cancer, and to evaluate the clinical effect (objective~     response rate) of the vaccination regime.~   "
256145|NCT00197912|"~     The aim of the study is to show if vaccination with autologous dendritic cells pulsed with~     peptides or tumor lysate in combination with adjuvant cytokines and Cyclophosphamide can~     induce a measurable immune response in patients with metastatic malignant melanoma, and to~     evaluate the clinical effect (objective response rate) of the vaccination regime.~   "
256146|NCT00197899|"~     The purpuse of this study is to examine the acute phase respons when different doses of E.~     Coli Endotoxin is injected in healty volunters.~   "
256147|NCT00197886|"~     Norepinephrine is a drug used to increase blood pressure in patients with life-threatening~     infection. However, norepinephrine may limit the bloodflow to the gut, thereby causing~     relative lack of oxygen to the cells. This leads to increased formation of lactic acid.~      This study examines whether increasing the dose of norepinephrine leads to higher~     concentrations of lactic acid in the rectum and stomach in patients with life-threatening~     infection.~   "
256148|NCT00197873|"~     Chemotherapy may cause diarrhoea, which may be associated with treatment delay and~     infections. The purpose of the study is to investigate whether oral supplementation with~     lactobacilli will alleviate chemotherapy related diarrhoea. Patients diagnosed with advanced~     colorectal cancer and who will receive chemotherapy will be randomly assigned to receive~     either lactobacilli or placebo during chemotherapy. The study is a prospective, multicenter,~     randomized, double-blind, placebo-controlled study. The primary outcome measure is frequency~     of moderate/severe diarrhoea. The study will also address safety and tolerability of~     chemotherapy, response to chemotherapy, and serum growth factor levels.~   "
256149|NCT00197860|"~     The purpose of this study is to show if vaccination with autologous dendritic cells pulsed~     with peptides or tumor lysate in combination with adjuvant cytokines can induce a measurable~     immune response in patients with metastatic renal cell carcinoma, and to evaluate the~     clinical effect (objective response rate) of the vaccination regime.~   "
256150|NCT00197847|"~     Purpose of the study is to investigate and quantify known and possible new riskfactors for~     nosocomiel infection and death in the intensive care setting.~      As new riskfactors Mannose Binding Lechtin and Procalcitonin are chosen and compared to~     established riskfactors.~   "
256151|NCT00197834|"~     This prospective, naturalistic, open label study will test the hypothesis that Depakote is~     correlated with a reduction in elevated Cohen-Mansfield Agitation Index (CMAI) verbal and~     physical agitation and aggression scales over a 6-week period among patients with elevated~     scores on those scales, and that these positive results can be achieved with fewer side~     effects than with other agents. In addition, patients will be rated with respect to changes~     in the Clinical Global Impression (CGI) at baseline, week 1, 3, and 6 and the~     Neuropsychiatric Inventory (NPI) at baseline and week 6.~   "
256152|NCT00197821|"~     To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain~     pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged~     50-80 years, and subsequent antibody persistence and response to boosting.~   "
256302|NCT00195780|"~     The purpose of the study is to evaluate the long-term safety profile of the Investigational~     Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in~     children and adolescents ages 10-17.~   "
256155|NCT00197782|"~     To measure the magnitude and persistence of the antibody response to a booster dose of Hib~     conjugate vaccine given between 9 months and 4 years of age to UK children who had completed~     primary immunisation with 3 doses of Hib vaccine given at 2/3/4 months of age either as a~     combined D/T/wholecellpertussis/Hib or D/T/acellularpertussis/Hib vaccine.~   "
256156|NCT00197769|"~     The purpose of the trial is to determine the minimum of doses of a new nine valent~     pneumococcal conjugate vaccine required to protect UK infants and toddlers~   "
256157|NCT00197756|"~     The purpose of this study is to analyze stored samples and data collected during the conduct~     of the study A Trial of Vitamins in HIV Progression and Transmission (HD32257). The aims~     are to examine the effect of vitamin supplementation on HIV infected women during pregnancy~     on a number of parameters in breastmilk.~   "
256158|NCT00197743|"~     This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant~     women in Tanzania would slow disease progression and enhance their overall health.~   "
256159|NCT00197730|"~     The purpose of this study is to examine the effects of multivitamin (B, C, E) supplementation~     on reducing the risk of morbidity and mortality outcomes among children born to HIV positive~     mothers, compared to placebo supplementation.~   "
256160|NCT00197704|"~     The purpose of this study is to determine the efficacy of micronutrient supplementation among~     patients with active tuberculosis, half of who are co-infected with HIV-1~   "
256161|NCT00197691|"~     The purpose of this study is to learn about lower respiratory tract and bloodstream diseases~     among infants born to HIV positive mothers in Botswana. Study factors include how commonly~     infants get these diseases, the causes, and outcomes. The study will also try to measure the~     protective effect, if any, of breast feeding on respiratory disease illness and deaths.~   "
256162|NCT00197678|"~     The purpose of this study is to examine effects of daily administration of multivitamin~     supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to~     HIV positive women decreases the risks of low birth weight (<2500 g), and pre-term birth (<~     37 weeks gestation), compared to multivitamin supplements at doses above the RDA.~   "
256163|NCT00197652|"~     The goals of this study are to:~        1. determine the diarrheal rates, morbidity, mortality, and pathogens present among~          breast-fed infants born to HIV-infected mothers.~             -  analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts~               of infected mothers.~             -  comparison to rates among infants born to HIV uninfected mothers.~        2. link analysis of the functional quality of immunoglobulins in the breast milk of~          HIV-infected and uninfected mothers.~   "
256164|NCT00197639|"~     This study looks at the ways indinavir drug levels, when boosted with ritonavir, may vary~     from patient to patient. The study population are HIV+ Thai individuals.~   "
256165|NCT00197613|"~     The Adult Antiretroviral Treatment and Resistance Study, hereafter referred to as The~     Tshepo Study, is the first large-scale research study of antiretroviral therapy to treat~     AIDS and HIV infection in Botswana. The Tshepo Study is an open-label, randomized study~     comparing: (1) the rate of development and specific types of drug resistance mutations with~     various antiretroviral combination therapies to HIV-1C, the subtype of HIV found in southern~     Africa, and (2) the short and long-term effectiveness of two operational modifications of~     Directly Observed Therapy (DOT) medication adherence strategies for antiretroviral therapy.~     Specifically, treatment follow-up via the Standard of Care, the national standard of care as~     it evolves in Botswana, with intensive clinic-based follow up including regular adherence~     education sessions, will be compared to Community-Based Directly Observed Therapy (Com-DOT).~     Com-DOT involves the SOC with added community or family-based DOT. This Com-DOT component~     would involve a trained, community or family-based Medication Partner (mopati) who observes~     the patient take his or medications daily.~   "
256166|NCT00197587|"~     The purpose of this study is to find the most effective and safe treatment to prevent the~     passage of HIV from an infected mother to her baby.~   "
256167|NCT00197561|"~     The purpose of this study is to determine whether the oral administration of daily selenium~     supplements to HIV-1 positive pregnant women: enhances immune status and reduces the HIV-1~     viral load at six months postpartum, reduces the risk of lower genital shedding of HIV-1~     infected cells at 36 weeks of gestation, and reduces the risk of mastitis at six weeks~     postpartum, compared to placebo.~   "
256168|NCT00197548|"~     The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal~     loss, low birth weight and severe preterm birth in healthy (HIV negative) women.~   "
256169|NCT00197522|"~     We, the researchers at Hamilton Health Sciences, have developed a novel approach to cancer~     therapy using transfected dendritic cells (DCs) to generate enhanced immunity to defined~     tumor antigens. Dendritic cells are highly specialized antigen presenting cells found in the~     bone marrow, lymph nodes, skin and thymus. Infection of DCs with Adenovirus (Ad) vectors~     incorporating genes for defined tumor antigens enables intracellular expression and major~     histocompatability complex (MHC)-restricted presentation of tumor peptides by transfected~     DCs. Given the potent immunostimulatory properties of DCs and ability to use gene transfer to~     load DCs with tumor antigen, we hypothesize that administration of transduced autologous~     DCs may have potential therapeutic benefit as a cancer vaccine. We have examined Ad-tumor~     antigen DC based vaccination in murine models of breast cancer and melanoma. In both models,~     injection(s) of Ad-transduced DCs results in highly potent immune activation and~     antigen-specific anti-tumor responses. In these models, high levels of antigen-specific,~     cytotoxic effector lymphocytes that recognize and kill cancer cells directly correlates with~     a therapeutic response (tumor regression and/or complete protection of animals subsequently~     re-challenged with tumor cells). Animals demonstrating specific in vitro immunity are~     protected against subsequent injection of cancer cells. Moreover, we have observed complete~     resolution and significant long-term survival in animals with established metastatic disease~     with no demonstrable toxicity. As opposed to vaccination protocols with tumor peptides or~     purified epitopes that are MHC-I restricted (i.e. HLA-A2), we have found that injection of~     DCs transduced with a vector expressing the entire tumor antigen results in peptide~     presentation from both MHC-I and MHC-II complexes. The subsequent immune response is~     comprised of both CD4+ and CD8+ T cell populations. Thus, Ad-based gene transfer of tumor~     antigens appears to be an efficient approach: (1) enabling sustained endogenous peptide~     processing, and (2) facilitating DC-specific presentation to the host immune system. We have~     shown that using a replication deficient adenovirus vector expressing Her-2/neu DNA under the~     control of a human mouse mammary tumor virus (MMTV) promoter that we can transfect bone~     marrow derived DCs (AdHer2/DC). These cells are then used to immunize recipient mice against~     tumour challenge with Her2 transgenic tumour cells. The protection is antigen specific (anti~     Her2). On the basis of these pre-clinical studies we will initiate a pilot trial of the~     AdHer2/DC vaccine in Her -2/neu overexpressing patients with metastatic breast cancer.~     Long-term goals and implications of possible results: The goals of this initial pilot phase I~     study are to evaluate the safety and dosing schedule of the vaccine therapy. The vaccine will~     be tested in subsequent phase II and III studies to determine efficacy in comparison to~     standard therapies. The long-term goals are to eventually test this therapy in the adjuvant~     breast cancer setting in Her-2/neu overexpressing patients.~   "
256170|NCT00197509|"~     The purpose of this study is to see if providing training using a Sit-to-Stand protocol for~     residents of Long-Term Care Facilities who have had a stroke will increase their independence~     in performing Sit-to-Stand.~   "
256171|NCT00197496|"~     Achieving independent ambulation is an important goal of hip fracture rehabilitation, as it~     is predictive of returning to the community and of future health problems. Current research~     regarding post-hip fracture rehabilitation is sparse. Body weight supported treadmill~     training (BWSTT) is a novel approach to retrain walking abilities. BWSTT may be ideal for~     retraining walking after hip fracture, as it is task-specific and alleviates the demands of~     maintaining balance while walking skills are trained. The use of the harness may provide a~     sense of security for the patient, facilitating walking training. The proposed project will~     investigate the feasibility and tolerability of BWSTT after hip fracture, and its impact on~     function, mobility, quality of life and fear of falling. It is hypothesized that BWSTT 3-5~     times weekly in acute hip fracture patients will improve function, mobility, quality of life~     and reduce fear of falling.~   "
256172|NCT00197483|"~     Dopamine has been closely associated with prefrontal function. The hypothesis that a lower~     dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed~     in the patients of schizophrenia is of a heuristic value in guiding research in this area.~     This hypothesis led us to test whether pergolide, a D1/D2 agonist, could improve negative~     symptoms and cognitive impairments prevailing in most patients with schizophrenia. This~     double-blind placebo controlled study will investigate the remedial effect of pergolide on~     negative symptoms and cognitive impairments in schizophrenia.~   "
256303|NCT00195767|"~     To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective~     in the treatment of bipolar I disorder in children and adolescents.~   "
256173|NCT00197470|"~     Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis~     of peptic ulcer and gastric cancer. We intended to clarify the association between~     polymorphisms of pro-inflammatory and anti-inflammatory cytokines, and the susceptibility to~     gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who~     have higher risks for gastrointestinal disease development.~   "
256174|NCT00197457|"~     Helicobacter pylori (H. pylori) eradication increases the serum pepsinogen (PG) I/PG II ratio~     and the percentage change in PG I/PG II ratios was found to be a useful marker of H. pylori~     eradication (e.g., the PG method). We studied whether the PG method could be an early~     diagnostic marker of H. pylori eradication even in patients persistently treated with a~     proton pump inhibitor. Sixty-two H. pylori-positive patients underwent H. pylori-eradication~     therapy, followed by treatment with a PPI to cure ulcers. Serum levels of PG I and PG II were~     measured before, at the end of, and at 4 weeks after the eradication therapy. At more than~     one month after the end of treatments, 13C-urea breath test (UBT) was performed. The cut-off~     values of percentage changes in PG I/PG II ratios for the diagnosis of eradication of H.~     pylori were set in proportion to PG I/PG II ratios before eradication in accordance with our~     previous report. Using the results of UBT as the standard, the percentage change in serum PG~     I/PG II ratios is useful as an early diagnostic marker for judgment of H. pylori eradication~     irrespective of PPI treatment.~   "
256175|NCT00197444|"~     The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin~     (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal~     squamous cell carcinoma.~   "
256176|NCT00197431|"~     S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug~     of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits~     dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces~     gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the~     researchers investigate the influences of differences in activities of CYP2A6 and DPD on~     pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer~     patients treated with S-1.~   "
256177|NCT00197418|"~     Proton pump inhibitors (PPIs) are mainly metabolized in the liver by CYP2C19, one of the~     cytochrome P450 isoenzymes, which shows a genetic polymorphism associated with enzyme~     activities. The most essential role of a PPI in H. pylori eradication therapy is to make~     antibiotics more stable and bioavailable in the stomach by raising intragastric pH to neutral~     levels.~      Most patients who have failed in the eradication of H. pylori infection by triple therapy~     with a PPI, amoxicillin (AMPC) and clarithromycin (CAM) at standard doses have extensive~     metabolizer (EM) genotypes of CYP2C19 and/or are infected with CAM-resistant strains of H.~     pylori.~      Four-times daily dosing of a PPI could achieve complete gastric acid inhibition. Dual therapy~     with 4-times daily dosing of a PPI and AMPC could yield sufficient re-eradication rates in~     patients with EM genotype of CYP2C19.~      Metronidazole (MNZ)-based re-eradication therapy, such as triple PPI/AMPC/MNZ therapy, also~     achieved high eradication rates and has been recommended as the second line therapy in Japan.~     But carcinogenic actions of MNZ have been unclear.~      The purpose of this study is to compare the re-eradication rates of H. pylori infection by~     the dual high-dose PPI/AMPC therapy and triple PPI/AMPC/MNZ therapy, and to validate the~     efficacies of these re-eradication regimens as second line eradication therapies.~   "
256178|NCT00197405|"~     Colorectal cancer (CRC) is the second common cause of death in the Western world, and is very~     increasing in Japan. Fecal occult blood test (FOBT) is used routinely for CRC screening,~     which has been shown to reduce the incidence, morbidity, and mortality of CRC. However, there~     is a need to develop a novel method to improve sensitivity. The investigators reported that~     Fecal COX-2 assay, one of fecal RNA test, is potentially useful for colorectal cancer~     screening (Gastroenterology 127; 422-427, 2004). So the investigators planed to compare fecal~     RNA test with FOBT for detecting colorectal cancer and adenoma.~   "
256179|NCT00197392|"~     The purpose of this non-significant risk study is to establish initial baseline infection~     rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic~     impregnated catheter) and to compare relative rates of ventriculostomy-related infection~     between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized~     open label study~   "
256180|NCT00197379|"~     The purpose of this study is exploiting the new drugs for androgenetic alopecia because there~     are still no effective and safe topical drug for androgenetic alopecia. Roxithomycin is one~     of the macrolide antibiotics that has immunomodulatory effects. We firstly found that~     roxithromycin increases the rate of murine and human hair follicle elongation in vitro.~     Therefore, we apply this drug on this disease therapy.~   "
256181|NCT00197366|"~     It has been shown that treatment of HIV-positive women with antiretroviral medication during~     pregnancy reduces the risk of HIV transmission to the child. However, such treatment could~     lead to the selection of resistant virus strains in the mother. The object of this study is~     to check HIV+ pregnant women for resistance mutations in HIV before and after the~     antiretroviral therapy they receive during pregnancy. HIV-positive newborns will also be~     tested, to see if a resistant virus strain was transmitted from mother to child.~   "
256182|NCT00197353|"~     This study aims to compare human subjects receiving epidural bupivacaine local anesthetic at~     different doses and concentrations and to assess the effect on vasodilatation~     (sympathectomy), sensory and motor block.~      The hypothesis is that the drug concentration is more important than drug dose in the~     determination of the extent and intensity of differential sympathetic, sensory and motor~     block following epidural local anesthetic.~   "
256183|NCT00197340|"~     Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important~     disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental~     blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these~     patients and typically, obstetric management involves interventional delivery, particularly~     problematic when remote from term. This study assess the hypothesis that epidural local~     anesthetics may improve UPBF in these patients.~   "
256184|NCT00197327|"~     This study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated~     (0.25%) bupivacaine.~      We hypothesize that patients randomize to receive the concentrated drug will require more~     drug, will have a more profound motor block, will be more likely to require instrumental~     delivery and will be less satisfied than those receiving dilute epidural drugs.~   "
256185|NCT00197314|"~     This is a randomized controlled trial comparing two methods of exercise for the treatment of~     stress incontinence ( loss of urine after physical exertion) in women. We are comparing the~     Paula method of circular muscle exercise, in which circular muscles controlling sphincters of~     the body (such as the eyes, mouth and rectum) are exercised, with pelvic floor training~     (Kegel exercises) in women in the community. The study hypothesis is that the effectiveness~     of circular muscle exercises is equivalent to pelvic floor training among women with this~     disorder.~   "
256186|NCT00197301|"~     Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious~     among the elderly. A Vaccine given as a nasal spray may improve compliance and local~     immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and~     together they enhance the local immune response in mice when given as nasal spray.This study~     aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to~     the commercial muscular vaccine.~   "
256187|NCT00197288|"~     The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix)~     in terms of the immune response elicited and the safety/ any symptoms that may occur for up~     to six months after vaccination.~   "
256188|NCT00197275|"~     The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3~     production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and~     meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB~     (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single~     injection.~   "
256189|NCT00197262|"~     Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following~     allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of~     allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly~     referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus,~     rhinorrhea, and pruritic, watery, red eyes. The primary objective of this study is to compare~     the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle~     placebo nasal spray in adult and adolescent subjects (12 years of age and older) with~     seasonal allergic rhinitis (SAR) caused by ragweed pollen.~   "
256190|NCT00197249|"~     To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the~     concomitant administration of Typherix and Havrix, and when compared to the administration of~     monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the~     persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the~     first dose of the study vaccine.~   "
256191|NCT00197236|"~     This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose~     inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis~     combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15~     months of age. The Protocol Posting has been updated in order to comply with the FDA~     Amendment Act, Sep 2007.~   "
256192|NCT00197223|"~     As a result of the recent supply shortages in the U.S., as well as an anticipated increase in~     demand during the coming years, GSK Biologicals is pursuing licensure of Fluarix in the U.S.~     under the accelerated approval process; marketing approval most likely will be granted before~     the start of this clinical trial. GSK proposes to support U.S. licensure of Fluarix with this~     confirmatory post-marketing study. The purpose of the study is to evaluate the efficacy of a~     single dose of Fluarix in preventing influenza in adults during the 2005/2006 Influenza~     season.~   "
256193|NCT00197210|"~     The main objectives of this study are to determine vaccine efficacy against severe rotavirus~     (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two~     years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to~     definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.~   "
256194|NCT00197197|"~     The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist~     GW873140 or placebo in combination with an optimized background regimen in~     treatment-experienced HIV-infected subjects with R5/X4-tropic virus~   "
256195|NCT00197184|"~     To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface~     antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of~     the study vaccine.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
256196|NCT00197171|"~     To evaluate the persistence of immune response 5 years and 6 years after the first vaccine~     dose.~   "
256197|NCT00197158|"~     GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the~     currently licensed monodose hepatitis B vaccine in a population with well documented~     hepatitis B immunological response to the vaccine (Belgium).~   "
256198|NCT00197145|"~     The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist~     GW873140 or placebo in combination with an optimized background regimen in~     treatment-experienced HIV-infected subjects with R5-tropic virus~   "
256199|NCT00197132|"~     Fluid management study in patients with insulin resistance.~   "
256200|NCT00197119|"~     To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface~     antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first~     dose of the study vaccine.~   "
256201|NCT00197106|"~     This study is being conducted to investigate whether in childhood salmeterol/ fluticasone~     propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd~     delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally~     we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms~     of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing~     management of asthma in children.~   "
256202|NCT00197093|"~     This study is a placebo-controlled study to assess the safety and tolerability of a novel~     antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight~     days. Assessments include blood sampling to determine drug concentrations, psychiatric~     assessments while under treatment, and movement assessments to evaluate potential side~     effects.~   "
256203|NCT00197080|"~     The purpose of this study is to assess the efficacy and safety of ropinirole XR in the~     treatment of adults with Restless Legs Syndrome (RLS).~   "
257214|NCT00183638|"~     This study will develop and evaluate the effectiveness of tailored web-based messages in~     promoting condom use among young adults.~   "
256204|NCT00197067|"~     GSK Biologicals is developing in partnership with the Malaria Vaccine Initiative at PATH a~     candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children~     living in malaria endemic areas. The vaccine would offer protection against malaria disease~     due to the parasite Plasmodium falciparum and also would provide protection against infection~     with hepatitis B virus. Studies conducted using the formulation RTS,S/AS02A (0.25 ml dose) in~     children and adults have shown to be safe. Currently all intramuscular vaccines in the EPI~     schedule are administered at a dose volume of 0.5 ml and in this context, a new variant of~     RTS,S/AS02D (0.5 ml dose) formulation has been composed which has the same active~     constituents in the same quantities as in a 0.25 ml dose of RTS,S/AS02A. In this study,~     RTS,S/AS02D (0.5 ml dose) was compared to the existing formulation, RTS,S/AS02A (0.25 ml~     dose).~   "
256205|NCT00197054|"~     The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30%~     efficacy against clinical episodes of malaria and approximately 58% efficacy against severe~     malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine~     RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army~     Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B~     vaccine to the African adults to establish safety and immunogenicity in this population.~     Preliminary indication of vaccine efficacy with this adjuvant will be established by~     monitoring the time to the first infection with Plasmodium falciparum.~   "
256206|NCT00197041|"~     Malaria is an important cause of death and serious illness among Mozambican children.~     Although the risk of malaria can be reduced by drugs and by impregnated bed nets, it would be~     helpful if children could be protected against malaria by a vaccine.~      GSK Biologicals is developing in partnership with Malaria Vaccine Initiative at PATH a~     candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children~     living in malaria endemic areas. The vaccine would offer protection against malaria disease~     due to the parasite Plasmodium falciparum and also would provide protection against infection~     with hepatitis B virus. Previous studies have shown the candidate malaria vaccine RTS,S/AS02~     to be safe when administered in adults and children aged 1-11 years. However, to assess if~     this vaccine could provide protection against malaria in children, this study has been~     undertaken.~   "
256207|NCT00197028|"~     GSK Biologicals is developing in partnership with the Program for Appropriate Technology in~     Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine~     immunization of infants and children living in malaria endemic areas. The vaccine would offer~     protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine~     would also provide protection against infection with hepatitis B virus (HBV).~      This trial is being carried out following the demonstration of efficacy of a previous version~     of the malaria candidate vaccine in children in Mozambique: there, the vaccine demonstrated~     approximately 30% efficacy against clinical episodes of malaria and approximately 58%~     efficacy against severe malaria disease.~      In order to integrate the malaria vaccine into the Expanded Program on Immunization (EPI)~     regimen, in malaria-endemic regions, for this trial, a 0.5 ml dose of GSK 257049 vaccine has~     been developed. The Protocol Posting has been updated in order to comply with the FDA~     Amendment Act, Sep 2007.~   "
256208|NCT00197015|"~     This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose~     inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a~     varicella (chickenpox) vaccine in children as young as 15 months of age.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
256209|NCT00197002|"~     This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose~     inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in~     children as young as 15 months of age.~   "
256210|NCT00196989|"~     This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a~     range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects~     with T2DM (Type 2 Diabetes Mellitus).~   "
256211|NCT00196976|"~     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one~     dose of four different formulations of the MenACWY conjugate vaccine when given to healthy~     children aged 12-14 months and 3-5 years. The selection of the best formulation will be based~     on data obtained up to one month after the vaccine dose.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
256212|NCT00196963|"~     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one~     dose of four different formulations of the MenACWY conjugate vaccine when given to healthy~     subjects aged 15-19 years. The selection of the best formulation will be based on data~     obtained up to one month after the vaccine dose.~   "
256213|NCT00196950|"~     The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and~     persistence up to three years after administration of one dose of the MenACWY conjugate~     vaccine when given to young adults aged 18-25 years.~   "
256214|NCT00196937|"~     Infection with human papillomavirus (HPV) has been clearly established as the central cause~     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the~     uterus or womb). This infection may go away by itself, but if it does not go away (this is~     called persistent infection), it can lead in women over a long period of time to cancer of~     the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals~     HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start.~     Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly~     according to a 0-1-6 month schedule. The study will be extended to assess long-term safety~     and immunogenicity of the HPV-16/18 vaccine.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
256239|NCT00196612|"~     The combination of two nucleoside analogues and one protease inhibitor is a highly active~     antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral~     load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side~     effects and the same efficacy. The aim of the study was to evaluate if the once daily~     combination presents the same efficacy than the HAART therapy with less side effects and a~     better adherence.~   "
256304|NCT00195754|"~     The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote~     ER is safe in the reduction of occurrence of migraine headaches in adolescents.~   "
256215|NCT00196924|"~     Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and~     genitals in men and women. Several types of HPV infection are transmitted by sexual activity~     and, in women, can infect the cervix (part of the uterus or womb). This infection often goes~     away by itself, but if it does not go away (this is called persistent infection), it can lead~     in women over a long period of time to cancer of the cervix. If a woman is not infected by~     HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the~     safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen~     and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects~     will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered~     intramuscularly according to a 0-1-6 month schedule.~   "
256216|NCT00196911|"~     Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus~     compared with drug treatment alone in patients with advanced Parkinson's disease.~   "
256217|NCT00196898|"~     Fibrotic valvular heart diseases are known as rare complications of long-time therapy of~     Parkinson's disease with ergot-derivatives including some ergot-dopamine agonists. The aim of~     this study is to assess the incidence of valvular heart disease, which may be an ergot-drug~     agonists side-effect or an overall complication of all dopamine agonists. Incidence,~     prevalence and addiction of dose or intake duration are not known so far. The reversibility~     of the changes is unknown too. To answer these questions the present study is designed as a~     cross sectional study followed by a 2 year follow-up prospective cohort study.~   "
256218|NCT00196885|"~     The purpose of the study is to tests the hypothesis, that N-acetylcysteine (a~     thiol-antioxidant)improves the exercise training effect on cancer patients that experience~     weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology.~   "
256219|NCT00196872|"~     In the recent AGO-study, a dose-dense and dose-intensified sequence of Epirubicin -~     Paclitaxel - Cyclophosphamide has shown superior efficacy compared to a conventionally dosed~     sequence of Epirubicin / Cyclophosphamid and Paclitaxel and was therefore chosen as standard~     treatment in this study.~      The experimental arm of EC-TX combines several strategies: the combination of EC will be~     administered every 2 weeks as a dose-dense regimen, the combination of TX can also be~     considered as dose-dense due to the weekly application of paclitaxel. Furthermore there is~     clinical evidence, that a combination of capecitabine and Paclitaxel provide synergistic~     effects with improved tumour response. A randomized phase III study could demonstrate a~     survival benefit of a combination of capecitabine with Docetaxel in patients with metastatic~     breast cancer. This synergistic effect is probably based on the preclinical observed~     taxane-mediated up-regulation of thymidine phosphorylase in the tumour cell, which give drive~     to an increased transformation of capecitabine to its active form 5-Fluorouracil. Apart from~     this synergy, the EC-TX regimen includes now 4 highly active compounds for the treatment of~     breast cancer. The total doses of Epirubicin and Paclitaxel are identical in both arms. The~     dosage of Cyclophosphamide is lower in the experimental arm, which is preferred due to the~     induction of leukaemia at higher doses of Cyclophosphamide. The duration of both arms with 18~     and 20 weeks is nearly similar.~      The 2 by 2 factorial design of the trial provides the additional possibility to explore the~     efficacy of a bisphosphonate as another strategy to further improve the prognosis of node~     positive breast cancer.~   "
256220|NCT00196859|"~     This trial is done to determine the role of adjuvant chemotherapy with capecitabine in~     patients ≥ 65.~   "
256221|NCT00196846|"~     Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure~   "
256222|NCT00196833|"~     Women who were diagnosed with breast cancer during their pregnancy may be registered in this~     trial.~      Data is collected on the foetal outcome 4 weeks after delivery, maternal outcome of pregnancy~     as well as the breast cancer therapy applied (treatment, response to chemotherapy, type of~     surgery), diagnostic procedures applied (palpation, US, mammogram) and the outcome of mother~     and child after 5 years of therapy.~   "
256223|NCT00196820|"~     Study done in patients with metastatic breast cancer in order to determine the efficacy of~     capecitabine~   "
256224|NCT00196807|"~     The primary goal of this study is to develop and evaluate a print-based method of patient~     education with a decision tool that is designed to provide detailed information about~     prostate cancer and to clarify patient preferences and values, ultimately assisting men in~     making an informed screening decision.~   "
256225|NCT00196794|"~     Approximately 520 patients will be entered into this study taking place throughout Australia~     and Europe. This study aims to determine if an investigational drug is safe and effective for~     treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat~     episodes of CDAD. The investigational drug will be evaluated in comparison to current~     standard antibiotic treatment, so all patients will receive active medication. All study~     related care is provided including doctor visits, physical exams, laboratory tests, and study~     medication. The total length of participation is approximately 6 weeks.~   "
256226|NCT00196781|"~     We plan to test the effectiveness of a recently developed computer-based program that is~     designed to improve patient knowledge about prostate cancer treatments. It is also designed~     to help men clarify their values using a computer-based 'decision aid.' A decision aid gives~     patients tools to help them understand their own values and how these values may be related~     to their choice of different forms of therapy for prostate cancer. In order to test the~     effectiveness of the decision aid, men will be assigned on a chance basis to receive either~     1) the computer program that includes the information about prostate cancer treatments alone,~     or 2) the computer program that contains both the information and the decision aid. We expect~     that men in decision aid group will be more active in their treatment decision and will have~     improved knowledge, quality of life, and satisfaction with the treatment decision relative to~     men who only receive the information.~   "
256227|NCT00196768|"~     Summary~      Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by~     the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML).~     Thereby it can be separated from all other forms of acute leukemia.~      By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be~     reached. On average, about 10% of patients still die in the early phase of the treatment and~     about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by~     qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the~     individual kinetics of MRD and to identify patients with an imminent hematological relapse.~      A standardized treatment for patients with relapsed APL has not yet been established. With~     arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting~     molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose~     dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower~     concentrations. ATO was also successfully administered before allogeneic and autologous~     transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe~     and in the USA.~      In the present protocol, ATO is given for remission induction:~        1. in patients with hematological or molecular first or subsequent relapse of APL and~        2. in patients who do not reach a hematological or molecular remission after first line~          therapy.~      Induction therapy with ATO is the mandatory part of the protocol.~      After remission induction, there are several options for postremission therapy. Factors which~     have influence on the treatment decision in the individual case are:~        1. the eligibility for allogeneic transplantation~        2. the eligibility for autologous transplantation~        3. the presence or absence of contraindications against intensive chemotherapy~        4. the PCR status after induction and during follow up (RT-PCR of PML/RARa, sensitivity~          10-4)~      A mandatory form of post-remission therapy is not defined in the protocol. Data and outcomes~     of any post-remission therapy should be documented in order to collect data of treatment~     after ATO.~      The following stratification of post-remission therapy can be performed according to the~     decision of the treating physician:~      Patients with a HLA-compatible donor who are suitable for allogeneic stem cell~     transplantation should be transplanted. In patients with a positive PCR one cycle of~     intensive chemotherapy (HAM) before transplantation should be considered and patients with a~     negative result are immediately transplanted without preceding chemotherapy. In patients who~     do not qualify for allogeneic, but for autologous transplantation, the intensity of the~     chemotherapy (Ara-C dose of the HAM cycle) is scheduled according to the PCR status after ATO~     and to the patient's age. In patients under 60 years, the recommended single Ara-C dose is~     scheduled to 3 g/m² in case of a positive PCR result and to 1 g/m² in case of a negative PCR~     result after ATO. In all patients aged over 60 years, the Ara-C dose should be uniformly~     reduced to 1 g/m² independent of the PCR status. Patients who are not eligible for allogeneic~     or autologous transplantation (too old, no stem cells collected, PCR positive stem cell~     transplant, contraindications against intensive chemotherapy) receive three further cycles~     with ATO and ATRA. The group of patients not qualifying for autologous transplantation, but~     without contraindications against intensive chemotherapy should receive an age adapted HAM,~     whenever a positive PCR persists or reappears after the three maintenance cycles of ATO. A~     close monitoring of the PCR of PML/RARa after each treatment cycle is part of the protocol.~      The main objective of the protocol is to take advantage of the expected low toxicity of ATO~     and to keep the part of chemotherapy as low as possible.~   "
256228|NCT00196755|"~     The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to~     calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal~     dialysis.~   "
256283|NCT00196040|"~     The primary objective of this study is to demonstrate the safety and efficacy of the PFX~     Closure System when utilized for patent foramen ovale (PFO) in patients suffering from~     cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief~     neurological dysfunction), migraine or decompression illness.~   "
256229|NCT00196742|"~     The Fabry Registry is an ongoing, international multi-center, strictly observational program~     that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of~     treatment status. No experimental intervention is involved; patients in the Registry undergo~     clinical assessments and receive care as determined by the patient's treating physician.~      The objectives of the Registry are:~        -  To enhance the understanding of the variability, progression, and natural history of~          Fabry disease, including heterozygous females with the disease;~        -  To assist the Fabry medical community with the development of recommendations for~          monitoring patients and reports on patient outcomes to help optimize patient care;~        -  To characterize and describe the Fabry population as a whole; and~        -  To evaluate the long-term safety and effectiveness of Fabrazyme®~   "
256230|NCT00196729|"~     This study was conducted in patients with differentiated thyroid cancer who had undergone~     near-total thyroidectomy. After surgery patients were randomized to one of two methods of~     performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid~     tissue). One group of patients who took thyroid hormone medicine and were euthyroid [i.e.~     their thyroid stimulating hormone (TSH) levels are normal], and received injections of~     Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second~     group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e.~     their TSH levels were high), and were given oral radioiodine. All patients received the same~     amount of radioactive iodine (100 mCi or 3.7 GBq of 131I). Approximately 8 months later,~     whole body scans were performed on all patients to learn whether the thyroid remnants had~     been successfully ablated. The safety profile of Thyrogen when used for radioiodine remnant~     ablation also was assessed. The Quality of Life, the radioiodine uptake and retention into~     the thyroid bed, as well as radiation exposure to the remainder of the body also were~     assessed in both groups of patients.~   "
256231|NCT00196716|"~     People with Fabry disease have an alteration in their genetic material (DNA) which causes a~     deficiency of the alpha-galactosidase A enzyme. This enzyme helps to break down and remove~     certain types of fatty substances called glycolipids. These glycolipids are normally~     present within the body in most cells. In people with Fabry disease, glycolipids build up in~     various tissues such as the liver, kidney, skin, and blood vessels because~     alpha-galactosidase A is not present, or is present in small quantities. The build up of~     glycolipid levels (also referred to as globotriaosylceramide or GL-3) in these tissues is~     thought to cause the clinical symptoms that are common to Fabry disease. Symptoms commonly~     appear during childhood with pain in the hands and feet. This trial is designed to evaluate~     the efficacy of a lower dose of Fabrazyme in patients who initially received 1.0 mg/kg every~     2 weeks of Fabrazyme by investigating if the achieved clearance of glycosphingolipid deposits~     in the vascular endothelium of the kidney can be maintained at a lower dose.~   "
256232|NCT00196703|"~     -  Aphasia, the loss or impairment of language caused by brain damage, is one of the most~          devastating cognitive impairments of stroke. Aphasia can be treated with combination of~          speech-language therapy and drugs. Conventional speech-language therapy in chronic~          aphasic subjects is of little help and several drugs have been studied with limited~          success. Therefore other therapeutic strategies are warranted.~        -  Recent data suggest that drugs (memantine) acting on the brain chemical glutamate may~          help the recovery of cognitive deficits, included language, in subjects with vascular~          dementia. The present study examines the safety profile and efficacy of memantine paired~          with intensive language therapy in subjects with stroke-related chronic aphasia (more~          than 1 yr. of evolution).~   "
256233|NCT00196690|"~     -  Aphasia (impairment of language function due to brain damage)may be treated with~          speech-language therapy and drugs. Several drugs have been studied but with limited~          success.~        -  Recent data suggest that the neurotransmitter acetylcholine may be reduced in brain~          damaged subjects and that drugs that stimulates acetylcholine activity may help recovery~          of aphasic deficits particularly when paired with speech-language therapy.~        -  Recent evidence indicates that medicaments acting on the neurotransmitter acetylcholine~          may promote improvement of aphasic deficits and our previous open-label study of~          donepezil in post-stroke aphasia showed benefits in all patients and observed benefit~          were long-lasting (6 months).This study will test the safety and efficacy of donepezil~          (an agent acting on acetylcholine)in subjects with stroke-related chronic aphasia (more~          than 1 yr of evolution).~   "
256234|NCT00196677|"~     The purpose of this study is to determine if certain food additives are effective in the~     treatment of glaucoma, improving and reversing the progress of the disease.~   "
256235|NCT00196664|"~     Depression is a common side effect of interferon in the treatment of chronic hepatitis C. The~     aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant~     agent, in the prevention of depression induced by PEG-interferon given for the treatment of~     chronic hepatitis C.~   "
256236|NCT00196651|"~     HIV-specific immune responses are preserved in patients treated early during primary~     infection.The trial evaluated whether the addition to HAART of IL-2 alone or combined with an~     immunization procedure might enhance HIV immune responses and improve viral control after~     HAART discontinuation~   "
256237|NCT00196638|"~     Treatment of acute primary HIV infection may improve long-term outcome. However, optimal~     treatment is still debated. The ANRS 112-INTERPRIM trial evaluates three different~     therapeutical strategies, combining permanent or intermittent HAART and a cytokine,~     interferon alpha, in order to determine which combination allows the best control of HIV~     viremia after 24 weeks of antiretroviral treatment interruption~   "
256238|NCT00196625|"~     HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side~     effects and the great number of pills reduces adherence to the treatment, and induces~     therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated.~     The aim of the study is to compare the antiviral efficacy of this salvage therapy combining~     lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside~     reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom~     multiple antiretroviral regimens had failed.~   "
256284|NCT00196027|"~     The primary objective of this study is to demonstrate the safety of the PFX Closure System~     when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke,~     transient ischemic attacks or paradoxical embolism.~   "
256240|NCT00196599|"~     In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple~     combination with protease inhibitor is recommended. Such therapy induces side effects and the~     number of pills may reduce therapy adherence. The aim of this study is to evaluate the~     efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with~     CD4 cell count over 100/mm3, antiretroviral naive.~   "
256241|NCT00196586|"~     The purpose of this pilot study is to evaluate efficacy and safety of addition of IL-2 to~     pegylated interferon alpha 2a and ribavirin in HIV-HCV coinfected patients non-responders~     after three months of standard therapy with pegylated interferon alpha 2a and ribavirin. IL-2~     may enhance numbers and function of CD4 T lymphocytes and specific anti-HCV immune responses~     and could participate to the control of HCV replication~   "
256242|NCT00196573|"~     The purpose of this study is to compare the effectiveness of arthroscopic subacromial~     decompression (acromioplasty) to arthroscopic subacromial bursectomy (no acromioplasty) in~     rotator cuff impingement syndrome. The investigators' hypothesis is that arthroscopic~     subacromial decompression provides no additional benefit, as evaluated with disease specific~     quality of life measures, compared to arthroscopic bursectomy.~   "
256243|NCT00196560|"~     The purpose of this study is to determine whether immobilizing the affected shoulder of first~     time anterior shoulder dislocation patients in external rotation (vs immobilization in~     traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24~     months.~   "
256244|NCT00196547|"~     The purpose of the study is to determine if Montelukast added to other therapy, if any, will~     reduce the severity of asthma symptoms in children during the high incidence of respiratory~     viral infections that occur in children in the post Labor Day school return period.~   "
256245|NCT00196534|"~     The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in~     stopping surgical bleeding within 10 minutes of application.~   "
256246|NCT00196521|"~     Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of~     surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with~     physical activity, coughing, sneezing, etc.Patients in the study will have an operation to~     improve urinary incontinence symptoms. This will involve inserting a mesh sling to help~     support the urethra (tube leading into your bladder). During the operation, the study doctor~     will use tension-free vaginal obturator system. The study will include women diagnosed with~     Stress Urinary Incontinence who have completed their families.~   "
256247|NCT00196508|"~     This is a randomized controlled trial and multi-centered study with a 2-arm design. The~     treatment group will receive topical skin adhesive for skin closure of their wound and the~     control will receive sutures. Subjects will be assessed at follow-up visits. Patients are~     required to maintain a diary postpartum.~   "
256248|NCT00196495|"~     Pelvic floor prolapse is a general term used to describe various clinical conditions that are~     associated with pelvic floor (muscles that support the vagina) relaxation in female~     patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing~     of the soft tissue structures that support the pelvic organs. These tissues become~     compromised because of a weakened or damaged.The purpose of the study will be to demonstrate~     the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.~   "
256249|NCT00196482|"~     Double-blind randomized controlled trial to investigate the impact of two human milk~     fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.~      Two different compositions are tested, main difference is in electrolyte composiiton.~   "
256250|NCT00196469|"~     This study is designed to test an incidental finding of a previous trial in which post hoc~     analysis showed that the rate of intensive care newborns requiring mechanical ventilation was~     lower in the group receiving heparin with the continuous infusion as compared to the placebo~     group.~   "
256251|NCT00196456|"~     The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal~     patients~   "
256252|NCT00196443|"~     The purpose of this study is to investigate if wearing of compression stockings influences~     the skin moisture. Conservative stockings are compared with urea containing compression~     stockings to find out if using urea prevents dehydration of the skin while wearing the urea~     compression stockings. Secondary aim was to find out if urea containing stockings increase~     the compliance to wear the compression stockings regulary by patients with diagnosed chronic~     venous insufficiency.~   "
256253|NCT00196430|"~     The purpose of this study is to investigate whether the treatment of acute neurodermitis with~     silver-contained textiles is equivalent or more effective to the conservative exogenous~     treatment with a corticosteroid. Secondary aim is to define skin comfortability of the~     textiles.~   "
256254|NCT00196417|"~     Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated~     heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia~     (HIT).~   "
256255|NCT00196404|"~     This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two~     doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure~     urge incontinence, urinary urgency and elevated urinary frequency~   "
256256|NCT00196391|"~     This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo~     and oral micronized progesterone in inducing withdrawal bleeding in women with secondary~     amenorrhea.~   "
256257|NCT00196378|"~     This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to~     evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe~     symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy~     and/or oophorectomy.~   "
256258|NCT00196365|"~     This study is being conducted to evaluate the effects of treatment with Seasonique an~     extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the~     typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study~     duration will be approximately 9 months. Patients will be required to record menstrual pain~     in a daily diary.~   "
256259|NCT00196352|"~     This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral~     contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for~     up to an additional three consecutive years.~   "
256285|NCT00196014|"~     The purpose of this study is to validate the psychometrics of the Individual Workload~     Perception Scale (IWPS).~   "
256260|NCT00196339|"~     This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used~     as add-on therapy for prostate cancer patients with hot flashes following surgical or~     medical castration. All prostate cancer therapy must be stable for at least 45 days before~     entering the study and must remain stable throughout this 12-week study. Patients will~     maintain a daily paper diary to record the frequency and severity of hot flashes during the~     treatment period.~   "
256261|NCT00196326|"~     This is an open-label, single treatment study. All subjects will receive one year of oral~     contraceptive therapy with DR-1011. Study participants will receive physical and~     gynecological exams, including Pap smear. During the study, all participants will be required~     to complete a diary.~   "
256262|NCT00196313|"~     This study is being conducted to evaluate the effects of treatment with Seasonique an~     extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the~     typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to~     extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9~     months. Patients will be required to record menstrual pain in a daily diary.~   "
256263|NCT00196300|"~     The objective of this study was to determine the prognostic utility of established risk~     predictors following acute ST elevation myocardial infarction in patients over 75 years of~     age.~   "
256264|NCT00196287|"~     The purpose of this study was to investigate differences in risk prediction in female~     post-infarction patients.~   "
256265|NCT00196274|"~     The purpose of this study was to develope and evaluate a new method for risk stratification~     which predicts high mortality risk in patients with cardiac disease based on simultateous~     examination of high resolution ECG, continuous arterial pressure and a breathing signal.~   "
256266|NCT00196261|"~     The purpose of this study is to investigate the performance of established and new risk~     preditors in predicting long term-mortality (up to ten years) of post-infarction patients.~   "
256267|NCT00196248|"~     Sudden cardiac arrest is one of the most common causes of death in industrial countries. The~     main objective of this study is to built up a register of all out-of hospital resuscitation~     in a defined area. According to this register, it is possible to evaluate for example~     predictors of survival to improve training and organisation of prehospital resuscitations.~   "
256268|NCT00196235|"~     The purpose of this study was to evaluate the performance of established and new risk~     predictors in predicting mortality in post-infarction patients suffering from diabetes~     mellitus~   "
256269|NCT00196222|"~     In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia~     are compared: The standard technique of radiofrequency energy delivery is compared with the~     new approach of cryo-energy application.~   "
256270|NCT00196209|"~     The aim of this randomized study is to evaluate the efficacy of two different approaches for~     conversion of persistent atrial fibrillation, the non-invasive one (external electrical~     cardioversion) and the invasive one (catheter ablation).~   "
256271|NCT00196196|"~     The purpose of this study is to determine the agreement rate between the CODMAN Valve~     Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in~     order to support an alternative to X-ray confirmation with respect to the valve adjustment~     process.~   "
256272|NCT00196183|"~     The purpose of this study is to compare two strategies of catheter-based treatment of~     paroxysmal atrial fibrillation: Pulmonary vein isolation either alone or combined with~     electrogram-guided substrate-ablation.~   "
256273|NCT00196170|"~     This randomized study compares two energy sources for the catheter based ablation of typical~     isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and~     the cryo-ablation technique regarding the acute and long term efficacy and safety.~   "
256274|NCT00196157|"~     In this randomized study dealing with the ablative treatment of persistent atrial~     fibrillation, two ablation strategies are compared: a more anatomically guided linear~     ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the~     electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac~     electrograms thought to maintain atrial fibrillation.~   "
256275|NCT00196144|"~     The purpose of this study is to evaluate the effect of individual adjustment of the~     postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber~     pacemakers.~   "
256276|NCT00196131|"~     Hypothesis: During severe brain trauma (injury, surgery) the ensuing inflammatory response in~     the central nervous system (CNS) results in a decrease in the expression of the transporter~     protein p-glycoprotein (PGP) in the blood brain barrier. This loss results in the penetration~     into the brain of certain drugs that are normally excluded by the transporter protein. In~     this study the working hypothesis is that the agitation observed in patients with CNS trauma~     treated with morphine is related to the inflammation evoked loss of PGP in the blood brain~     barrier and the accumulation of the morphine metabolite 3-morphine glucuronide.~   "
256277|NCT00196118|"~     The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter~     can be removed after a period of implantation, when implanted in patients for the prevention~     of pulmonary thromboembolism.~   "
256278|NCT00196105|"~     This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol~     Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of~     palliative treatment of malignant obstructive jaundice.~   "
256279|NCT00196092|"~     The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith~     Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac~     aneurysms.~   "
256280|NCT00196079|"~     The ASPECT study is an Asian multicenter, randomized, controlled, triple-blinded study~     designed to evaluate the ability of the Cook Incorporated Paclitaxel Eluting Supra G Coronary~     Stent to reduce restenosis in the coronary artery.~   "
256281|NCT00196066|"~     The purpose of this study is to assess the ability of a vascular stent to maintain an open~     iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a~     long history of use in medical devices. The stent self-expands once inside the artery where~     it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow~     over the stent helping to hold it in place.~   "
256282|NCT00196053|"~     The purpose of this observational registry is to collect a continuum of meaningful clinical~     data on the ARCHIMEDES implantable pump in pain management~   "
256286|NCT00196001|"~     Males and females may exhibit different responses to testing of adrenal function. The~     hormones responsible for controlling adrenal function are ACTH (adrenocorticotropic hormone~     or corticotropin) and CRH (corticotropin-releasing hormone). Adrenal function is tested with~     an ACTH stimulation test. ACTH stimulates the adrenal glands to produce cortisol. Cortisol~     levels are measured, and a certain peak level indicates normal adrenal gland function.~     Females may produce more cortisol in response to ACTH testing than males. This difference may~     be due to certain proteins, called G proteins. The hormones controlling adrenal function,~     ACTH and CRH, work through G proteins. Females may have more G proteins than males allowing~     for the increased cortisol response to ACTH stimulation.~      We speculate that:~        1. There may be differences in adrenal responsiveness to ACTH stimulation testing between~          healthy males and females.~        2. ACTH and CRH induce their own function.~        3. Sex differences in adrenal responsiveness to ACTH stimulation testing may be related to~          sex differences in G protein expression.~      In this study, cortisol, a hormone produced by the adrenal glands, will be measured before~     and after the administration of ACTH.~      This study will also measure G proteins. G proteins are found in the white blood cells. White~     blood cells from females may have more active G proteins than white blood cells from males.~     Sex differences may be augmented after exposure to ACTH.~   "
256287|NCT00195988|"~     Open label, randomised, prospective, onecentre Investigator Driven Study:~      Comparison of two protocols of immunosuppression after liver Tx in children:~      A: Study group - FK506-MMF. Immunosupression protocol: Methylprednisolone 10 mg/kg~     intraoperatively i.v. FK506 Day 0 or 1 orally (0,15 mg/kg/D in two doses).MMF max. dosage 30~     mg/kg/D p.o. day 0 through day 90.~      B. Control group - Tacrolimus, steroids. Immunosupression protocol: Methylprednisolone 10~     mg/kg bm intraoperatively Children < 25kg bm: Methylprednisolone taper from 100 mg/D on day 0~     to MP 10 mg on day 7 Children > 25kg bm: Methylprednisolone taper from 200 mg/D on day 0 to~     MP 20 mg on day 7 Week 2-4 Prednisone - 0,5-0,3 mg/kg/D; Week 4-12 Prednisone –0,3-0,2~     mg/kg/D; Month 4-6 Prednisone 0,2 – 0,1 mg/kg/D Month 7 – Steroid withdrawal FK506 Day 0 or 1~     orally (0,15 mg/kg/D in two doses).~      Primary end points:~      Number of rejections, number of steroid-resistant rejections.~      Secondary end points:~      Patients and graft survival Dyslipidemia one year after transplantation Hypertension one year~     after transplantation Hyperglycemia/Diabetes de novo one year after transplantation Renal~     function before Tx and 1 year after Tx~   "
256288|NCT00195975|"~     The current study is designed to assess relationships between anxiety/stress, autonomic~     nervous system balance, and electrical activity in the stomach before and after~     eating/drinking in children with abdominal pain.~   "
256289|NCT00195962|"~     The goal of this study is to identify infants who are at risk for developing problems related~     to being breast-fed.~   "
256290|NCT00195949|"~     Pyloric stenosis is a condition that develops in infants and that leads to an obstruction of~     the channel going out of the stomach. This study is being performed to determine if there is~     an advantage to the laparoscopic approach or the open approach for the surgical correction of~     the enlarged pylorus.~   "
256291|NCT00195936|"~     This study will measure the effect of cinacalcet (Sensipar) on parathyroid hormone (PTH)~     secretion in children and adolescents with hypophosphatemic rickets (XLH). The investigators~     are seeking evidence that patients with XLH may benefit from treatment with cinacalcet by~     achieving better control of PTH secretion.~   "
256292|NCT00195923|"~     The purpose of this study is to compare traditional triple antibiotic therapy against dual~     single day dosing antibiotic therapy in the management of perforated appendicitis in~     children.~   "
256293|NCT00195910|"~     To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a~     standard weight-based dose of IV morphine in adults presenting to the ED with acute severe~     pain.~   "
256294|NCT00195897|"~     Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's~     and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity,~     resulting in a marked left ventricular function impairment that may lead to heart failure.~      The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on~     cardiac function monitoring using echocardiography or radionuclide angiography. The aim of~     this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin~     and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline~     cardiotoxicity.~   "
256295|NCT00195884|"~     The main purpose of this study is to assess the impact of exercise training (aerobic~     exercise, resistance exercise, combined aerobic and resistance exercise) versus a sedentary~     waiting list control on glycemic control (as reflected in reduced hemoglobin A1c [HbA1c]),~     body composition (weight, body mass index [BMI], waist circumference, total body fat,~     visceral and subcutaneous abdominal fat, mid-thigh muscle cross-sectional area), lipids~     (Apo-B, Apo-A1, Apo-B/A1 ratio, low density lipoprotein (LDL) particle diameter,~     high-sensitivity C-reactive protein) and quality of life.~   "
256296|NCT00195871|"~     The primary objective of this study is to evaluate the safety and the efficacy of an adult~     acute lymphoblastic leukaemia type chemotherapy in patients less than 60 years with~     lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed~     intensification.~   "
256297|NCT00195858|"~     The purpose of this study is to evaluate the effects of resistance training, aerobic~     training, and combined aerobic and resistance training on percent body fat, measured using~     Magnetic Resonance Imaging (MRI), in sedentary post-pubertal overweight or obese youth aged~     14-18 years.~   "
256298|NCT00195845|"~     The purpose of this study is to determine if galantamine augmentaion improves cognition in~     euthymic bipolar patients. In addition, the effect of galantamine on clinical measures of~     functioning and psychopathology will also be assessed.~   "
256299|NCT00195819|"~     The purpose of the study is to assess the safety and clinical efficacy of adalimumab in~     subjects with active ankylosing spondylitis~   "
256300|NCT00195806|"~     The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote~     ER is safe in the reduction of occurrence of migraine headaches in adolescents.~   "
256301|NCT00195793|"~     The objective of this study is to evaluate the effects of adding Tricor 145 mg to once daily~     atorvastatin 20 mg on CHD lipid laboratory parameters.~   "
256305|NCT00195741|"~     The purpose of this study is to determine whether Depakote ER is safe and effective in the~     reduction of occurrence of migraine headaches in adolescents.~   "
256306|NCT00195728|"~     The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and~     acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low~     back pain.~   "
256307|NCT00195715|"~     To evaluate the long-term maintenance of response, safety and tolerability of repeated~     administration of adalimumab in subjects with Crohn's disease who participated in and~     successfully completed Protocol M02-404 or Protocol M04-691.~   "
256308|NCT00195702|"~     The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of~     adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term~     safety and maintenance of efficacy following repeated administration of adalimumab (during~     open-label extension phase) in patients with persistently active rheumatoid arthritis who~     were receiving concurrent methotrexate therapy.~   "
256309|NCT00195689|"~     The purpose of the study is to assess the long-term safety and clinical efficacy of~     adalimumab in treatment of moderate to severely active psoriatic arthritis~   "
256310|NCT00195676|"~     The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab~     treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate~     the effectiveness of adalimumab retreatment in participants who had therapeutic response to~     adalimumab and were then withdrawn from adalimumab treatment.~   "
256311|NCT00195663|"~     The purpose of the study is to assess the safety and efficacy of adalimumab in combination~     with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the~     long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10~     years.~   "
256312|NCT00195650|"~     The purpose of the study was to assess the long-term safety and clinical efficacy following~     repeated administration of adalimumab in patients with rheumatoid arthritis.~   "
256313|NCT00195637|"~     This study will evaluate patients with Hereditary Inclusion Body Myopathy (HIBM) and examine~     the effects of immune globulin (IG) treatment on muscle and muscle function. HIBM is a~     progressive neuromuscular disease that begins in early adulthood, primarily affecting limb~     muscles. It results from mutations of the gene that is responsible for producing sialic acid,~     a sugar normally found on the surface of certain proteins, including alpha-dystroglycan,~     which is involved in muscle function. Some patients with HIBM have decreased sialic acid on~     the alpha-dystroglycan protein, which may be the cause of their muscle weakness. IG is a~     protein in the blood that carries a large amount of sialic acid. This study will administer~     IG to patients with HIBM and determine if the sialic acid in IG is taken up by muscle cells~     in these patients and if it can restore some of their muscle function.~      Four patients with HIBM will be admitted to this study at the NIH Clinical Center for~     evaluation and IG treatment. The evaluation lasts about 1 month. After completing baseline~     studies (see below), patients receive two intravenous doses of immune globulin (on days 6 and~     7), followed by measurement of muscle strength 2 days later (day 9). They receive additional~     IG infusions on days 13, 20, and 27. A final set of tests is performed on day 29. Patients~     may leave the hospital on pass when no studies are being done.~      A patient's initial evaluation includes:~        -  History and physical examination, neurological examination, eye examination~        -  24-hour urine collection~        -  Blood tests on two separate days~        -  Photographs showing the extent of muscle affected~        -  Chest x-ray, electrocardiogram (EKG), and echocardiogram~        -  Two muscle biopsies, one before and one after the IG treatments. For this procedure, a~          small sample of muscle tissue is surgically removed for examination under the~          microscope.~        -  Muscle strength and endurance testing, including the following:~      The patient uses pulleys attached to machines that measure the strength of 24 different~     muscle groups~      The patient walks for 6 minutes and performs exercises~      To evaluate swallowing, the patient swallows a thick substance called barium~      The patient's tongue strength is measured using a specialized instrument.~      -Magnetic resonance imaging (MRI) of the muscles of the thigh or calf: MRI uses a magnetic~     field and radio waves to produce detailed pictures of organs and tissues. During the scan,~     the subject lies on a table in a narrow cylinder containing a magnetic field, wearing ear~     plugs to muffle loud noises that occur with electrical switching of the magnetic fields. He~     or she can speak with a staff member via an intercom system at all times during the~     procedure.~      The neurological and muscle strength and endurance evaluations are repeated on study days 9~     and 29.~   "
256314|NCT00195624|"~     This study will evaluate the safety and usefulness of a new immunosuppressive drug,~     alemtuzumab (Campath ), in patients with severe aplastic anemia (SAA). SAA is a rare and~     serious blood disorder in which the bone marrow stops making red blood cells, white blood~     cells and platelets. Alemtuzumab is a monoclonal antibody that attaches to and kills white~     blood cells called lymphocytes. In certain types of aplastic anemia, lymphocytes are~     responsible for the destruction of stem cells in the bone marrow, leading to a decrease in~     blood counts. Because alemtuzumab destroys lymphocytes, it may be effective in treating~     aplastic anemia. Alemtuzumab is currently approved to treat chronic lymphocytic leukemia and~     is also helpful in other conditions that require immunosuppression, such as rheumatoid~     arthritis and immune cytopenias.~      Patients 2 years of age and older with severe aplastic anemia whose disease does not respond~     to immunosuppressive therapy or has recurred following immunosuppressive therapy may be~     eligible for this study. Participants undergo the following tests and procedures:~        -  Pretreatment evaluation: Patients have a medical history, physical examination, blood~          tests, electrocardiogram (EKG), echocardiogram, 24-hour Holter monitor (continuous~          24-hour monitoring of electrical activity of the heart), bone marrow biopsy (withdrawal~          through a needle of a small sample of bone marrow for analysis).~        -  Placement of a central line, if needed: An intravenous line (tube) is placed into a~          major vein in the patient's chest. It can stay in the body for the entire treatment~          period and be used to give chemotherapy or other medications, including antibiotics and~          blood transfusions, if needed, and to withdraw blood samples.~        -  Alemtuzumab therapy: Patients are admitted to the NIH Clinical Center for the first few~          injections for close monitoring of side effects. After receiving an initial small test~          dose, patients begin the first of ten daily injections under the skin, each lasting~          about 2 hours. Once patients tolerate the infusions with minimal or no side effects,~          they may be given the remaining infusions on an outpatient basis. Patients who relapse~          after their initial response to alemtuzumab are given cyclosporine to see if this drug~          will boost their immune response.~        -  Patients receive transfusions, growth factors, and antibiotic therapy, as needed.~        -  Infection therapy: Patients are given aerosolized pentamidine to protect against lung~          infections and valacyclovir to protect against herpes infections.~        -  A blood test is done and vital signs are measured every day while patients receive~          alemtuzumab.~        -  Patients have an echocardiogram and 24-hour Holter monitor after the last dose of~          alemtuzumab.~        -  Blood tests are done weekly for the first 3 months after alemtuzumab administration,~          then every other week until 6 months.~      Patients return to the NIH for follow-up visits 1 month, 3 months, 6 months, and yearly for 5~     years after the last dose of alemtuzumab for the following tests and evaluations:~        -  Blood test~        -  Repeat echocardiogram at 3-month visit~        -  Repeat bone marrow biopsy 6 months and 12 months after alemtuzumab, then as clinically~          indicated for 5 years.~   "
256315|NCT00195611|"~     The aim of this study is to assess in France the impact of Prevenar on the possible evolution~     of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of~     children with AOM.~   "
256316|NCT00195598|"~     The purpose of this pilot study is to evaluate the improvement in social function following~     therapy with venlafaxine extended release (XR) in the treatment of panic disorder (PD) in~     comparison to paroxetine. An additional purpose of this pilot study is to obtain the~     tolerability of using venlafaxine extended release (XR) in the treatment of panic disorder~     (PD) in comparison to paroxetine.~   "
256317|NCT00195585|"~     The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of~     relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary~     endpoints include disease-free survival time, survival time, and safety.~   "
256318|NCT00195572|"~     The purpose of the study is to verify non-inferiority of survival time between~     Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable~     advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of~     responses, time to progression (TTP) safety and quality of life (QOL).~   "
256319|NCT00195559|"~     The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE)~     is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.~   "
256320|NCT00195546|"~     Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment~     of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence~     of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on~     changes from baseline in weight, breast pain, and health outcomes indicators.~   "
256321|NCT00195533|"~     The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam~     versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for~     fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be~     included in the monotherapy branch until completing the predicted number of cases. When this~     happens, the Coordinating Center will communicate it to the participant centers and from then~     the patients will be included in the combined therapy.~   "
256322|NCT00195520|"~     To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg~     administered to a population of Brazilian women in a continuous combined regime for hormone~     replacement therapy.~   "
256323|NCT00195507|"~     This study will provide a direct comparison of 'continuous therapy' and 'intermittent~     therapy' with withdrawal and retreatment upon return of psoriasis.~   "
256324|NCT00195494|"~     To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change~     and clinical disease activity in subjects with early RA over 12 months.~   "
256325|NCT00195481|"~     To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing~     surveillance setting.~   "
256326|NCT00195468|"~     Compare kidney function as measured by calculated creatinine clearance (using the method by~     Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with~     cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with~     subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation~     (Group II).~   "
256327|NCT00195455|"~     The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous~     regimen 17 b estradiol/trimegestone combination.~   "
256328|NCT00195442|"~     The purpose of this study is to investigate the effectiveness and safety of treatment with~     ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment~     will be done.~   "
256329|NCT00195429|"~     This study evaluates two different immunosuppression drug regimens in patients with a recent~     kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and~     Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.~   "
256330|NCT00195416|"~     To identify the following problems and questions with respect to the safety and effectiveness~     of Enbrel during the post-marketing period as required by Korea Food and Drug Administration~     (KFDA)'s regulations.~        1. Unknown adverse reactions, especially serious adverse reactions~        2. Change of the incidences of adverse reactions under the routine drug uses~        3. Factors that may affect the safety of the drug~        4. Factors that may affect the effectiveness of the drug~   "
256331|NCT00195403|"~     The objective of this investigation is to identify the following problems and questions with~     respect to the safety and efficacy of Enbrel during the post-marketing period as required by~     Korea Food and Drug Administration (KFDA)'s regulation.~        1. Unknown adverse reactions, especially serious adverse reactions~        2. Incidences of adverse reactions under routine drug uses~        3. Factors that may affect the safety of the drug~        4. Factors that may affect the efficacy of the drug~      This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403,~     0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have~     been combined into this record.~   "
256332|NCT00195390|"~     The purpose of this study is to identify the following problems and questions with respect to~     the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar,~     during the post-marketing period in Korea, as required by Korea Food and Drug Administration~     (KFDA) regulations.~        1. Adverse reactions (especially serious adverse reactions)~        2. Incidences of adverse reactions under routine vaccine use~        3. Factors that may affect the safety of the vaccine~   "
256333|NCT00195377|"~     The purpose of this study is to assess the safety of etanercept in patients with rheumatoid~     arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain~   "
256334|NCT00195364|"~     The purpose of this study is to evaluate long-term safety of etanercept in patients with~     rheumatoid arthritis who successfully have completed open-label safety study 0881A1-301-EU~   "
256335|NCT00195351|"~     This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and~     efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects~     with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms~     of cIAI will be included for enrollment. Subjects will be stratified at randomization for~     Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10.~     Subjects will be followed for efficacy through the test-of-cure assessment. Safety~     evaluations will occur through the treatment and post-treatment periods and continue through~     resolution or stability of the adverse event(s).~   "
256336|NCT00195338|"~     The purpose of the study is to determine the long term safety of Enbrel in adults with active~     rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in~     rheumatology practice patients. All patients initiated with Enbrel will be observed from the~     start of the study in Feb 2003 for a period of at least 5 years.~   "
256337|NCT00195325|"~     The purpose of this study is to evaluate the safety, tolerability, and MTD (maximum tolerated~     dose) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.~   "
256338|NCT00195312|"~     The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs~     that are used to help immune response) have an acceptable safety profile in treating~     individuals with HIV.~      A second purpose for this study is to understand how your immune system responds to the study~     vaccine with the adjuvants. Understanding these differences could be useful in several ways.~     First, it might help identify people whose disease is likely to respond to the study vaccine~     with the study adjuvants. Second, the information might be useful in developing other~     treatments for people whose disease does not respond to the study vaccine with the adjuvants.~   "
256339|NCT00195299|"~     This is an open-label, exploratory, biomarker study of intravenous temsirolimus given once~     weekly for 3 weeks to newly diagnosed, advanced stage head and neck cancer subjects prior to~     beginning their standard therapy for their specific disease. The primary objective of this~     study is to identify biomarkers of temsirolimus activity.~   "
256340|NCT00195286|"~     The primary objective is to study the efficacy of piperacillin/tazobactam in patients with~     complicated urinary tract infections~   "
256341|NCT00195273|"~     The purpose of this study is to compare the kidney function in patients who have received a~     transplanted kidney and were treated with the combination of sirolimus, daclizumab,~     mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine,~     mycophenolate and corticosteroids.~   "
256342|NCT00195260|"~     To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily~     schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated~     dose (MTD) in this subject population.~   "
256343|NCT00195247|"~     The purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose~     (MTD) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.~   "
256344|NCT00195234|"~     The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are~     used to help improve immune responses) have an acceptable safety profile in treating~     individuals with HIV.~      A second purpose of this study is to understand how the immune system responds to the study~     vaccine and adjuvants.~   "
256777|NCT00189488|"~     The main purpose of this study is to evaluate the effect of palifermin versus placebo in the~     reduction of severe acute graft versus host disease (GVHD) and severe oral mucositis.~   "
256345|NCT00195221|"~     Retrospective, multicenter study in patients with hemophilia B. This study will be placed at~     20 to 50 hemophilia treatment centers in North America and the EU, and is designed to~     estimate the frequency of Class II and III allergic reactions in association with the~     administration of any FIX concentrate.~      Following informed consent and eligibility, historical patient information including~     demographics, allergy history, hemophilia history, frequency and severity of allergic~     reaction(s), number of exposure days with products causing allergic reactions, exposure days~     to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of~     event(s), any other adverse event(s) occuring within 48 hours of onset of allergic~     reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and~     outcome, current status of patient, and results of any special studies (eg, skin or RAST~     testing, alloantibody analyses, ect) will be collected.~   "
256346|NCT00195208|"~     The purpose of this study is to demonstrate pharmacodynamic comparability between the~     pantoprazole spheroid formulation and the marketed tablet formulation.~   "
256347|NCT00195195|"~     The purpose of this study is to gather information about the long-term effects and safety of~     treatment with Rapamune in transplant patients.~   "
256348|NCT00195182|"~     The specific aims for this study are:~        1. To examine the relationship between perceived racism and medication adherence among~          hypertensive African-American patients.~        2. To determine if psychological stress and depression mediate the relationship between~          perceived racism and medication adherence.~   "
256349|NCT00195169|"~     This is an observational study to determine the association between social support and~     functional status after a myocardial infarct~   "
256350|NCT00195156|"~     The purpose of this study is to find out the highest tolerated dose of Depakote in~     combination with liposome encapsulated all-trans retinoic acid (ATRA-IV) in patients with~     advanced solid tumor malignancies.~   "
256351|NCT00195143|"~     The purpose of this study is to determine the safety of using a modified virus to transfer a~     gene called GAD into a region of the brain called the subthalamic nucleus in patients with~     advanced Parkinson's disease. The overall goal of this approach is to ultimately normalize~     the flow of information in several brain regions responsible for movement, to ultimately~     improve function in patients with this disorder. The current study is primarily designed to~     evaluate the safety of this approach, but patients are also being monitored for possible~     signs of effectiveness as well.~   "
256352|NCT00195130|"~     The primary objective of this prospective study is to develop a new method of classifying the~     prognosis of ambulatory patients according to their risk of long term mortality,~     institutionalization, morbidity (including the deterioration of pre-existing conditions or~     development of new problems) and functional deterioration.~   "
256353|NCT00195117|"~     The primary objective of this randomized trial is to evaluate a novel intervention of induced~     positive affect and induced self-affirmation to increase physical activity in patients with~     asthma.~   "
256354|NCT00195104|"~     The purpose of this study is to find out the effectiveness and side effects of arsenic~     trioxide in combination with low-dose ara-C.~   "
256355|NCT00195091|"~     Patients with moderate to high risk primary breast cancer (Stage II with more than 4 lymph~     nodes involved with cancer) III or Stage IV (without evidence of disease) will take~     tetrathiomolybdate (TM) pills for two years.~      The objectives of the study are to:~        -  Assess the safety and tolerability of tetrathiomolybdate in patients with breast cancer~          at high risk of tumor recurrence.~        -  Observe the disease-free survival of patients in this trial.~        -  Conduct background scientific experiments on tumor tissue and blood of patients in this~          study~   "
256356|NCT00195078|"~     The purpose of this study is to find out whether adding ZD1839 to standard treatment~     (Cisplatin and Radiation Therapy) of unresectable head and neck cancers is better than~     cisplatin and radiation alone.~   "
256357|NCT00195065|"~     To explore and illuminate the cultural, social, and psychological factors that either~     facilitate or serve as barriers to behavioral change in asthma patients.~   "
256358|NCT00195052|"~     The purpose of this study is to develop a technique for the intraoperative identification of~     human functional and epileptiform cortex using intrinsic signal imaging. The investigators~     propose that the ability to optically monitor neuronal activity in a large area of cortex in~     real-time will be a more sensitive and time-saving method than the electrical methods~     currently available. The applications of this technique will not only theoretically increase~     the safety and efficacy of many of neurosurgical procedures, but will be useful as an~     investigational tool to study human cortical physiology.~   "
256359|NCT00195039|"~     The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of~     patients with metastatic, androgen-independent prostate cancer.~   "
256360|NCT00195026|"~     This protocol will evaluate a new non-invasive infrared imaging system as an adjunctive tool~     for breast cancer detection that has been approved by the FDA. The technology and device have~     been developed by Infrared Sciences Corp. and has undergone more than 3 years of testing~     prior. The subject device's utility will be investigated with regard to its sensitivity~     toward breast cancer, however it records temperature data and other physiological parameters~     of the breast, and compares them to a database of patients with known breast health.~   "
256361|NCT00195013|"~     Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of~     peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.~   "
256362|NCT00195000|"~     The purpose of this study is to find out how safe and effective the combination of Mylotarg~     in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and~     advanced Myelodysplastic Syndrome over the age of 60 years.~   "
256363|NCT00194987|"~     The purposes of this study are to provide medical management by giving treatment to the~     mother that will bring up the fetal platelet count and to minimize the number of invasive~     procedures to the fetus (which may result in serious fetal injuries).~   "
256376|NCT00194818|"~     We, the investigators at University of Washington, plan on evaluating the effect of open~     label Asacol at a dose of 4.8 grams/day divided BID (twice per day) or TID (three times per~     day) on its ability to induce remission in patients with mild to moderately active ulcerative~     colitis. We hypothesize that both regimens will have the same efficacy and no difference in~     side effects.~   "
256364|NCT00194974|"~     This project is a clinical study of women with high blood pressure who become pregnant.~     Preeclampsia is a syndrome developing at the end of a pregnancy characterized by an abrupt~     rise in blood pressure (BP), blood clotting and kidney dysfunction, and may result in~     premature delivery, infant death, and maternal bleeding, kidney failure and stroke. The goal~     is to determine whether lowering blood pressure to a normal pressure of 120/80 is associated~     with a lower incidence of preeclampsia. Women who are completely healthy have a 5% chance of~     developing preeclampsia, however women with preexisting high blood pressure have a 25% chance~     of this complication. Several studies, including our own suggest that higher blood pressure~     early in pregnancy (<20 weeks) is associated with an even higher risk of preeclampsia.~     Currently we, the researchers at Weill Medical College of Cornell University, do not know how~     to treat women with high blood pressure and/or kidney disease during pregnancy. Keeping the~     BP in the normal range may be beneficial to the mother. On the other hand, we are not sure if~     the blood pressure lowering or the medications may or may not have adverse effects for the~     baby. Different trials to answer this question have been performed with no clear conclusions.~     Because of these uncertainties, we propose to compare two different strategies for treating~     women with high BP who become pregnant. We will treat half the women with BP medications to~     normalize BP (120-130/80 mm Hg) (experimental group) and the other half with the goal of~     keeping the BP slightly higher (140-150/90-100 mm Hg)(standard therapy group). We will~     determine which approach results in healthier pregnancies, and lower incidence of~     preeclampsia. Reducing the incidence of preeclampsia would be of significant benefit to both~     mothers and babies.~   "
256365|NCT00194961|"~     Circulating concentrations of cytokines, such as leptin, tumor necrosis factor-alpha and~     interleukins 1 and 6 are increased in patients with chronic kidney disease (CKD). In light of~     the increasing recognition that growth hormone receptor signaling involves cytokine pathway~     activation, the investigators hypothesize that maladaptation of cytokine regulation in~     chronic kidney disease may underlie growth failure. Secondly, they hypothesize that~     administration of recombinant human growth hormone (rhGH) will result in growth rate~     stimulation in pre-pubertal children with growth impairment due to chronic kidney disease by~     down regulation of the cytokine pathways.~      This is a non-randomized open-label study to evaluate the effect of recombinant human growth~     hormone on biochemical/metabolic and immunologic parameters in relation to body composition~     pre- and post-recombinant human growth hormone therapy of pre-pubertal growth hormone naive~     children. The efficacy of recombinant human growth hormone to improve growth velocity in~     pre-pubertal children with growth failure is a secondary objective. Fifteen children are to~     be studied over a six month period. Each patient will serve as his/her own control. Six~     months of growth data prior to study is required.~   "
256366|NCT00194948|"~     This study will determine the effectiveness of offering primary care patients their preferred~     treatment versus one that is less desirable in improving treatment adherence and outcome.~   "
256367|NCT00194935|"~     The purpose of this study is to find out the safety and feasibility of weekly topotecan~     consolidation therapy in patients with ovarian cancer.~   "
256368|NCT00194922|"~     The purpose of this study is to determine the tolerance and efficacy of the probiotic E. Coli~     Strain M17 on symptoms and Quality of Life in Individuals with Irritable Bowel Syndrome~     (IBS).~   "
256369|NCT00194909|"~     The purpose of this study is to study if sildenafil (Viagra) is effective in improving~     neuropathic pain. This will be an open label study at 3 doses of sildenafil (25 mg, 50 mg and~     100 mg). If this study suggests efficacy, the information will be used to plan a placebo~     controlled, double-blind study in the future.~   "
256370|NCT00194896|"~     The purpose of this research was to test whether one treatment was superior over another in~     the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody~     positive type 2 diabetic patients to determine whether treatment with rosiglitazone results~     in greater preservation of beta cell function compared to treatment with glyburide.~   "
256371|NCT00194883|"~     Children with chronic kidney failure often do not grow well. This study examines the possible~     causes of growth failure in these children and the response to recombinant human growth~     hormone. The growth hormone-insulin-like growth factor axis will be studied in relation to~     biochemical and immunological parameters as well as body compositional changes pre- and post~     recombinant human growth hormone therapy.~   "
256372|NCT00194870|"~     Patients with epilepsy undergoing deep brain stimulation (DBS) have electroencephalograms~     (EEGs) recorded before and during their stimulation treatment. Subsequently the investigators~     will be using computer-assisted analysis of the digitally-recorded EEG signals to assess the~     effects of DBS on the brain-wave frequency content and any abnormal seizure-like patterns~     that may be present.~   "
256373|NCT00194857|"~     This study is designed to test two separate strategies for treatment of anemia (low~     hemoglobin) and neutropenia (low white blood cells) in HIV/HCV coinfected patients who are~     being treated with pegylated interferon and ribavirin.~   "
256374|NCT00194844|"~     This is a randomized trial of three caring based interventions to see if we can help couples~     heal after miscarriage. All three are based on Swanson's theory of caring and Meaning of~     Miscarriage Model. The first, nurse caring, consists of three counseling sessions with a~     nurse. The second intervention, self-caring, involves watching three videotapes and~     completing three workbooks. The third, combined caring, involves receiving one counseling~     session with a nurse followed up with the three videotapes and workbooks. There is also a~     control group that receives no intervention. All interventions are administered at 1, 6, and~     11 weeks after study enrollment. Couples can enroll who are no more than 12 weeks post~     miscarriage of a pregnancy that ended at 20 weeks gestation or less. At 1, 6, 16, and 52~     weeks post enrollment we ask couples to complete mailed booklets that contain a variety of~     research questionnaires about their emotional health, integration of loss, and couple~     relationship.~   "
256375|NCT00194831|"~     The study will correlate the volumes of the brain obtained from magnetic resonance imaging~     (MRI) scans done at term gestation for infants born prematurely who weighed less than 1000~     grams at birth with their corresponding development at 18 months corrected age.~   "
256419|NCT00194233|"~     The purpose of this study is to investigate differences in protein expression profiles of~     blood and peritoneal fluid samples obtained from patients who do, and those who do not, have~     endometriosis seen during laparoscopic surgery. These profiles may include both known and~     novel markers for diagnosing endometriosis.~   "
256377|NCT00194805|"~     This study will examine the feasibility and short and-long-term efficacy of a web-based~     telehealth intervention with community-dwelling older adults who have been diagnosed with~     type 2 diabetes. Effectiveness will be evaluated using multiple measures within three~     different domains: 1) physical (glycosylated hemoglobin [HbA1C], weight, and lipid levels);~     2) behavioral (monitoring blood glucose levels, feet inspections, diet, and exercise~     frequency), and 3) psychosocial (depression, quality of life, social support, and adjustment~     to diabetes).~      This is a randomized controlled trial of a web-based telehealth intervention designed to~     improve self-management behaviors in a group of community dwelling older diabetics. Two~     groups of participants will be recruited and randomized over a four-month period during years~     01 and 02. Participants in the control group will receive standard diabetic care provided by~     their provider. Participants in the intervention group will receive computer training in the~     participant's home in how to access and utilize the web-based telehealth study webpage. The~     intervention will consist of a program designed and delivered via the Internet to improve the~     participants' diabetes self-management behaviors using behavioral and motivational strategies~     and cues to modify perceptions of self-efficacy and beliefs regarding the ability to affect~     the progress of the disease and change personal behavior.~   "
256378|NCT00194792|"~     This phase II trial is studying how well giving hormone therapy together with combination~     chemotherapy before and after surgery works in treating patients with stage I-IIIA breast~     cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen~     the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine~     ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving hormone therapy together with~     combination chemotherapy before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed. Giving these treatments after surgery may kill any~     tumor cells that remain after surgery~   "
256379|NCT00194779|"~     This phase II trial studies how well giving combination chemotherapy and filgrastim together~     before surgery works in treating patients with human epidermal growth receptor 2~     (HER2)-positive breast cancer that can be removed by surgery. Drugs used in chemotherapy,~     such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving combination chemotherapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed. Colony-stimulating factors, such~     as filgrastim, may increase the number of immune cells found in bone marrow or peripheral~     blood and may help the immune system recover from the side effects of chemotherapy. Giving~     doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel~     before surgery may be an effective treatment for breast cancer~   "
256380|NCT00194766|"~     The purpose of this study is to determine whether treatment with temozolomide can effect the~     survival of patients with advanced breast cancer or soft tissue sarcoma.~   "
256381|NCT00194753|"~     The primary objectives of the study are to evaluate the feasibility and toxicity of treatment~     with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks~     of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug~     to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing~     the incidence and severity of toxicity with these drugs to previous trials using these drugs~     in the same combination. We hypothesize metronomic, dose dense treatment as given in this~     study will be less toxic and more effective than historical regimens using the same drugs in~     a less metronomic, dose dense manner.~   "
256382|NCT00194740|"~     The two drugs used to treat metastatic breast cancer in this study may perform better when~     used together than when used separately. The use of another drug that prevents the most~     common side effect of the two-drug combination permits the delivery of both agents at closer~     to the full dose for either when used alone. We hypothesize that the two-drug combination~     used with G-CSF support will be more effective and less toxic than other standard regimens~     for the treatment of metastatic breast cancer.~   "
256383|NCT00194727|"~     The primary purpose of the study is to examine the safety and effectiveness of combination~     therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV~     breast cancer subjects. The study is designed to assess the safety and effectiveness of this~     combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity~     of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will~     be assessed by analyzing response rates, time to treatment failure, time to progression and~     overall survival. Our hypothesis is that the regimen will be more effective than standard~     historic regimens for this type and stage of cancer.~   "
256384|NCT00194714|"~     This phase I/II trial studies the side effects of vaccine therapy and to see how well it~     works in treating patients with stage IV major histocompatibility complex, class I, A2~     antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or~     ovarian cancer who are receiving trastuzumab. Giving booster vaccines made from HER2 peptides~     may help increase HER2 specific immunity and immune memory cells.~   "
256394|NCT00194571|"~     This is a 6-state randomized controlled trial (RCT) that uses a behavioral intervention to~     enhance parenting skills for school age children when a mother is recently diagnosed with~     early stage breast cancer. Efficacy analyses will include measures of the child's and~     mother's psychosocial adjustment, including enhanced parenting quality and skills related to~     the cancer.~   "
256395|NCT00194558|"~     The researchers will conduct a 12-month randomized controlled trial comparing usual care~     versus chronic disease management using the Internet among patients with type 1 diabetes~     receiving care in the Diabetes Care Center at the University of Washington.~   "
256469|NCT00193583|"~     In this phase I study we will characterize the safety, tolerability, maximum tolerated dose~     and dose-limiting toxicity of weekly bolus topotecan when administered in combination with~     two different dosing schedules of carboplatin. We will also evaluate any antitumor activity~     of these combination regimens.~   "
256470|NCT00193570|"~     This phase I study will characterize the safety, tolerability, and maximum tolerated dose and~     dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to~     different dosing regimens of docetaxel. We will also evaluate any anti-tumor activity of the~     combination regimen.~   "
256385|NCT00194701|"~     Of the more than 2 million Americans with heart failure (HF), up to 70% have disturbed sleep~     that worsens the dyspnea, fatigue, and reduced daytime function associated with HF. Exercise~     improves sleep in healthy people but the effects of exercise have not been tested in patients~     with HF. A controlled, randomized trial is proposed to compare the effects of 16 weeks of~     usual activity (control) with 16 weeks of regular, supervised walking exercise (treatment),~     on cardiac function and sleep. Approximately 170 subjects with NYHA Class I, II, or III~     stable heart failure will be recruited. Subjects in the treatment group will walk for~     exercise up to 5 times a week for up to 30 minutes.~      The purpose of this randomized trial is to examine the effects of 16 weeks of regular walking~     exercise on cardiac function, sleep, and quality of life in persons with stable New York~     Heart Association (NYHA) Class I, II or III heart failure.~      The specific aims are:~        1. To compare the physiologic measures of cardiac function (peak oxygen utilization,~          exercise capacity, nocturnal arterial oxygen desaturations, and heart rate variability)~          and self-reported quality of life (i.e., symptoms of dyspnea and fatigue, and the~          ability to perform activities of daily living) of patients randomized to walking vs.~          control condition.~        2. To compare the somnographic (sleep fragmentation, slow wave sleep, sleep efficiency) and~          self-reported (sleep effectiveness, sleep disturbance, and nap supplementation) measures~          of sleep for HF patients randomized to walking vs. control condition.~        3. Considering the extent of apnea-hypopnea episodes at study entry and group assignment~          (walking vs. control), explore whether HF patients with frequent apnea-hypopnea episodes~          (more than 20 per hour) in the walking group experience greater pretest-posttest~          improvements in physiologic cardiac and somnographic function, when compared with HF~          patients with few apnea-hypopnea episodes (less than 20 per hour) assigned to walking,~          or the control group of HF patients with frequent or few apnea-hypopnea episodes.~      HYPOTHESES:~        1. Heart failure patients who walk regularly will have better cardiac function than the~          control group.~           Heart failure patients who walk regularly will have higher self-reported quality of~          life, less shortness of breath/fatigue, and greater ability to perform activities of~          daily living than the control group.~        2. Heart failure patients who walk regularly will have better sleep than the control group.~        3. Heart failure patients with frequent episodes of slowed or stopped breathing during~          sleep who walk regularly will have a greater improvement in pretest-posttest measures of~          cardiac function than heart failure patients with few episodes of slowed or stopped~          breathing during sleep who walk regularly, or the control groups with frequent or few~          breathing difficulties during sleep.~      Heart failure patients with frequent apnea-hypopnea episodes who walk regularly will have a~     greater improvement (i.e., larger difference) in pretest-posttest somnographic sleep measures~     of efficient, fragmented, and slow wave sleep, than heart failure patients with few~     apnea-hypopnea episodes who walk regularly, or the control groups with frequent or few~     apnea-hypopnea episodes.~   "
256386|NCT00194688|"~     The objective is to evaluate the utility of a breath ammonia sensing device. In this study we~     will assess the effect of H. pylori infection on breath ammonia levels by measuring whether~     there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive~     patients compared to H. pylori negative patients.~   "
256387|NCT00194675|"~     The purpose of this research study is to determine whether the combination of the male~     hormone testosterone [T] in gel form and the oral drug dutasteride [D], used to shrink large~     prostate glands can safely reduce the size of the prostate gland and symptoms of prostate~     enlargement (called benign prostatic hyperplasia [BPH]) compared to T treatment alone in men~     with low testosterone (called hypogonadism).~   "
256388|NCT00194649|"~     The purpose of this research study is to help in the development of safe, effective and~     reversible male contraception. We are examining the impact of the drug Miglustat on sperm~     production in normal men.~      We want to see if Miglustat will inhibit sperm production in men and act as a reversible male~     contraceptive, as a study in mice administered Miglustat showed a reversible inhibition of~     sperm production. We believe Miglustat may have some potential as a safe, reversible male~     contraceptive.~   "
256389|NCT00194636|"~     The purpose of this study is to investigate, by means of a temporary sympathetic nerve block,~     the involvement of the sympathetic nervous system in Chronic Pelvic Pain Syndrome (CPPS).~     This study may also result in a new therapeutic approach for male CPPS.~   "
256390|NCT00194623|"~     Chronic pelvic pain syndrome (CPPS) is thought to affect approximately 8% of men aged 18 and~     older. Patients with this condition experience pain in the perineum, the genitalia, and the~     rectum. As well, there is associated voiding, sexual, and ejaculatory dysfunction. The impact~     of patient well-being is thought to be equivalent to patients with congestive heart failure.~     The etiology of this condition is unknown, thus making treatment very difficult. Researchers~     have pursued an infectious cause for the disease; however, studies have failed to~     substantiate this theory. Despite this, the main treatment offered to patients is long-term~     antibiotic therapy. Results from this treatment modality have been unsatisfactory.~      Other groups have postulated that the symptoms of CPPS may be secondary to neuromuscular~     factors. Some studies have demonstrated increases in pelvic muscular tone. Maneuvers such as~     prostate massage and levator massage have shown some benefit in relieving symptoms. Treatment~     with alpha-blockers to relax prostate smooth muscle has brought about improvement in a~     portion of patients. Use of generalized muscle relaxants has produced mediocre results.~      However, many of these neuromuscular treatments are generalized and do not target the~     perineal musculature directly. It is theorized that spasm of the perineal muscles triggered~     by an unknown noxious stimuli (e.g. infection) cause the pain and symptoms of CPPS. At our~     center, we have performed pilot studies using botulinum toxin A. Four patients were treated~     with Botox. 100 U were injected in three locations in the midline of the bulbocavernosus~     muscle. The bulbocavernosus muscle is easily accessible and shares innervation with the~     pelvic musculature. Patient's response to medication was measured by the NIH Prostatitis pain~     scale and as well as the University of Washington prostatitis pain scale. All patients~     reported resolution of symptoms. Remission lasted for duration of 10-12 weeks. No patients~     reported adverse events.~      HYPOTHESIS~      Botulinum toxin A is effective in the treatment of chronic pelvic pain syndrome in men.~   "
256391|NCT00194610|"~     Patients with interstitial cystitis have been well documented to have pelvic floor muscle~     tenderness as well as pain on bladder distension. Some investigators have even suggested that~     pelvic floor muscle pain is primarily the cause of bladder problems.~      Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the~     neuromuscular junction. It has been shown that this mechanism relieves pain in a number of~     muscle spasm-related syndromes.~      Because, at present, there is little effective therapy available for patients with~     interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve~     bladder and pelvic pain in these patients.~   "
256392|NCT00194597|"~     Viagra is a potent 5-PDE inhibitor that causes vasodilation in the penis and, therefore,~     erection in men with erectile dysfunction. Our hypothesis is that Viagra may improve the~     symptoms of men with Chronic Pelvic Pain Syndrome based on the following assumptions:~      Chronic Pelvic Pelvic Syndrome and Interstitial Cystitis involve poorly understood central~     and peripheral pain sensitization such as are seen in Chronic Sympathetic Dystrophy, also~     called Chronic Regional Pain Syndrome. This pain may be caused by constricted blood vessels~     resulting from past stress, injury or trauma~      Viagra will dilate sympathetically constricted vessels and improve pelvic blood flow in the~     same manner it does in men with erectile dysfunction.~      Since men with Chronic Pelvic Pain Syndrome often complain of sexual dysfunction; improving~     sexual function and, therefore, quality of life may improve overall well being and perception~     of pain.~   "
256393|NCT00194584|"~     The long-term goal of this research is to strengthen parents' abilities to manage the~     complexities of childhood chronic illness. To achieve this goal, the team of parents, health~     care professionals, and researchers proposes the following specific aim:~        -  Develop, implement, and test a unique psycho-educational program, Living with Childhood~          Chronic Illness (the Program), for effectiveness with parents of children who have~          chronic illnesses.~      The investigators propose the following hypotheses:~      At both 6 and 12 month follow-up points, parents taking part in the intervention, in contrast~     to control parents, will have:~        1. Greater perceived self-efficacy regarding their ability to manage the child's chronic~          condition;~        2. Greater parental ability to involve their child in shared management activities;~        3. Greater parental ability to cope at 6 and 12 months following the end of the~          intervention;~        4. Greater emotional health; and~        5. Greater parental perceived family quality of life.~   "
256396|NCT00194545|"~     Following significant reduction in antiretroviral drug prices over the past two years, more~     HIV-1 infected African adults and children are gaining access to treatment. However, due to~     complex drug regimens that have to be taken continuously, suboptimal adherence is likely to~     be a formidable challenge. As programs providing antiretroviral drugs in Africa scale up,~     achievement of excellent adherence is a high priority as this will result in maximum benefits~     from the drugs and forestall development of resistant virus. A better understanding of~     predictors of pediatric HAART adherence in African children is essential in order to~     formulate feasible, culturally appropriate, strategies to monitor and enhance adherence.~     There is also urgent need to evaluate simple, inexpensive interventions that are widely~     applicable in the African setting. The medication diary has been used empirically among HIV~     infected adults and children in Western countries, mainly as a tool for monitoring and to a~     lesser extent improving HAART adherence. Literacy levels have risen significantly in most~     African regions over the past few years, and the diary can also be further modified using~     pictures to suit parents of different literacy levels. We propose to conduct a randomized~     control trial to determine the effect of medication diaries and counseling versus counseling~     alone on HAART-adherence in HIV-1 infected children and their parents/caregivers in Nairobi~     Kenya.~   "
256397|NCT00194532|"~     Urinary tract infection (UTI) is a very common problem in young healthy women, afflicting~     approximately one-half of women by their late 20s. One of the most common antibiotics used to~     treat UTIs is ciprofloxacin, usually for a total of three days. However, increasing~     resistance to this antibiotic has raised concerns about its overuse for cystitis and~     generated interest in alternative agents. An alternative antibiotic which is approved for use~     in UTIs is cefpodoxime. However, there are few studies evaluating the efficacy and tolerance~     of this compound when given in a 3-day regimen as is commonly used for treatment of UTI. The~     major purpose of this study is to assess the efficacy and tolerance of a 3-day regimen of~     cefpodoxime versus ciprofloxacin for treatment of acute uncomplicated cystitis.~   "
256398|NCT00194519|"~     The University of Washington has received funding to conduct a proof-of-concept trial to~     assess the impact of suppression of genital herpes on HIV infectiousness. This study (the~     Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the~     HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the~     efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent~     transmission to his/her HIV negative partner(s). This randomized, double-blind,~     placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2~     suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom~     the HIV-positive partner is also HSV-2 seropositive with CD4 >250. The researchers hypothesis~     is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of~     daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant~     couples among whom the HIV-infected partner is HSV-2 positive.~      Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the~     HIV-positive partner is HSV-2 positive and has a CD4 count >250 will be recruited;~     participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo~     arm is assumed.~      The first study site began enrolling participants on 17 November 2005. As of September 2006,~     14 sites in Eastern and Southern Africa had participated in recruiting the 2300~     HIV-discordant couples enrolled to date.~   "
256399|NCT00194506|"~     This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module~     among type 2 patients at the University of Washington's Roosevelt General Internal Medicine~     Clinic.~   "
256400|NCT00194493|"~     The traditional procedure for cancer symptom and quality of life instrument administration is~     a paper questionnaire completed by the patient or research participant. The use of~     standardized, patient report instruments as routine assessment in clinical cancer care has~     been promoted, but infrequently reported and the utilization rate is low. Barriers to~     clinical use include the personnel cost of data collection, management of written~     questionnaires and the clinicians' unfamiliarity with the nature of the queries and numerical~     scale scores. Web-based electronic technology now has been developed and tested for~     feasibility using touchscreen, notebook computers and the computerized assessment program, a~     screening assessment providing usable and easily interpreted graphic output to cancer~     clinicians. The purpose of this study is to design and evaluate the clinical integration of~     the web-based computerized assessment in a major, multi-disciplinary academic medical center~     and cancer center. Consecutive outpatients who are evaluated for cancer therapy in each of~     the 2 setting sites, the University of Washington Medical Center and the Seattle Cancer Care~     Alliance, are able to communicate in English (or through one of the many interpreters~     available at the institutions), and are competent to understand the study information and~     give informed consent will be invited to participate. Clinicians caring for the patients in~     the sample will be invited to participate in evaluating the organizational impact. We will~     compare the outcomes of conducting assessment in the usual practices and procedures to the~     outcomes of using the computerized assessment program: appropriateness of referrals,~     efficiency, and usability. The computerized assessment will be completed prior to each~     participant's visit with the clinician, conducted at the first clinic visit, during the 4-6th~     week of treatment and again at a 30 day follow up visit. Graphical output will be immediately~     available to clinicians. Descriptive, comparative statistics will be used to evaluate the~     impact of the screening and longitudinal assessments.~   "
256401|NCT00194480|"~     Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV)~     infections. The purpose of this trial is to investigate the effectiveness of pegylated~     interferon in treating injection drug users (IDUs) with acute HCV.~   "
256402|NCT00194467|"~     The purpose of the study is to use valganciclovir to define the role of antiviral therapy in~     suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that~     valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in~     the mouth.~   "
256403|NCT00194454|"~     The primary aim of this study is to determine the effect of a nurse-delivered~     psychosocial/behavioral intervention on reduction of depression in community dwelling~     post-stroke patients. We expect the combined behavioral and pharmacologic intervention to be~     more effective than pharmacotherapy alone in sustaining the improvement in depression for the~     experimental group. Secondary aims are to examine the effect of the psychosocial/behavioral~     intervention time course and sustainability of response to treatment, effect on limitations~     in ability, limitation in participation and overall stroke impact in community-dwelling~     post-stroke patients, and to compare ischemic stroke survivors who are and are not depressed~     within the first four months following stroke by their 5-HTTLPR genotypes (s/s, s/l, or l/l).~   "
256418|NCT00194246|"~     We are interested in testing differences in cognitive function and food reactivity at various~     time points in individuals following low and high carbohydrate diets. We wish to achieve an~     understanding of these time-specific differences using repeated measures analysis of variance~     (ANOVA), with diet condition (low vs. high carbohydrate) as a between subject factor and time~     as a within-subject factor.~   "
256404|NCT00194441|"~     The aim of the initial proposal was to evaluate, in the context of optimal medical~     management, the impact of a bedside system of cerebral perfusion pressure (CPP) information~     feedback on nursing moment-to-moment management of CPP, and the relationship of that~     management to patient functional outcome at discharge, 3 and 6 months. The primary hypothesis~     being tested is that Glasgow Outcome Score (GOS) 6 months post acute care discharge will be~     significantly better in those monitored with the continuous CPP display.~      In the second phase of the study the adult study will be extended to children to determine if~     there is a critical threshold for CPP in children following brain injury based on their~     outcome at 3, 6, and 12 months. The primary outcome measure is the GOS at 12 months~     post-injury. The GOS, Behavior Rating Inventory of Executive Function, and PedsQOL will also~     be assessed at 3, 6, & 12 months, and the Adaptive Behavior Assessment System at 3 and 6~     months post-injury. In addition, the researchers will examine variability and complexity of~     physiologic measures, such as blood pressure, recorded during the intensive care unit stay of~     adults and children enrolled in the study. The researchers will study the association of~     these measures with risk for secondary brain injury and ability to predict differences in~     outcome. The researchers will also assess the value individuals place on varying outcomes~     following brain injury.~   "
256405|NCT00194428|"~     The purpose of this trial is to study the safety, tolerability and efficacy of an almond~     enriched hypocaloric diet on weight loss and weight maintenance, as well as on established~     and emerging cardiovascular risk factors in approximately 112 overweight and obese persons.~   "
256406|NCT00194415|"~     The objective of the study is to evaluate the acceptance and effect of type- specific HSV~     serologic testing of pregnant women on sexual behavior at the end of pregnancy.~   "
256407|NCT00194402|"~     Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this~     research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and~     together. This study will help show how the individual benefits of the two drugs taken~     separately can be combined when taken together.~   "
256408|NCT00194376|"~     Patients with a clinically indicated sleep study will be enrolled in this study. They will~     have a diagnostic and a therapeutic sleep study with continuous positive airway pressure~     ventilation. For both studies a pH probe will be placed nasal to measure the amount of acidic~     reflux during each study. Baseline levels of reflux from the diagnostic sleep study will be~     compared to reflux episodes while on continuous positive airway pressure ventilation.~   "
256409|NCT00194363|"~     The purpose of the PAL trial is to increase the understanding of the experiences of long-term~     breast cancer survivors.~      Study hypothesis: Strength training will not increase the rate of lymphedema or worsen~     lymphedema as compared to the non-exercising control participants.~   "
256410|NCT00194350|"~     The purpose of this study is to determine whether inherited thrombophilias (tendency toward~     blood clotting) increase the risk of failure of the embryo to implant in IVF. The specific~     condition to be studied is the presence or absence of the Leiden mutation of the Factor V~     gene.~   "
256411|NCT00194337|"~     RATIONALE: Diagnostic procedures, such as digital mammography, ultrasound, MRI, and PET~     scans, may help find breast cancer and find out how far the disease has spread.~      PURPOSE: This phase II/III trial is studying digital mammography, ultrasound, MRI, and PET~     scans to compare how well they find the extent and spread of breast cancer in women with~     newly diagnosed breast cancer.~   "
256412|NCT00194324|"~     This study uses MRI to detect the spread of the Miconozole Nitrate OVULE within the vagina.~     The effect of moderate amounts of physical activity on the spread will be evaluated, and~     compared to no physical activity.~   "
256413|NCT00194311|"~     The purpose of this study is to determine if maternal infection with human papillomavirus~     (HPV) is associated with pregnancy complications including spontaneous preterm delivery~     (sPTD), severe preeclampsia (PE), and poor fetal growth.~   "
256414|NCT00194298|"~     The main objective of the proposed research study is to determine the potential utilization~     of [18-F] Fluorodeoxyglucose (FDG) positron emission tomography (PET) in patients with~     complicated diabetic foot, especially in the diagnosis or exclusion of osteomyelitis in this~     setting. We intend to validate and establish the necessary criteria for making such a~     diagnosis and determine the accuracy of the technique through comparison with other existing~     modalities, including MRI, and patient outcome. We expect that at the completion of the~     proposed research, the role of these powerful imaging modalities will be clearly defined in~     the management of patients with this challenging and serious complication.~   "
256415|NCT00194285|"~     The main objective of the proposed research study is to determine the efficacy of [18-F]~     Fluorodeoxyglucose (FDG) positron emission tomography (PET) in differentiating infections~     from other complications such as loosening in patients with painful joint prosthesis. We~     intend to validate and establish the necessary criteria for making such a diagnosis and~     determine the accuracy of the technique through comparison with other existing modalities~     such as white blood imaging and patient outcome. We expect that at the completion of the~     proposed research, the role of this novel and powerful imaging modality will be clearly~     defined in the management of patients with this challenging and serious complication.~   "
256416|NCT00194272|"~     This study examines the safety and acceptability of a novel two dose regimen of~     methotrexate to treat ectopic pregnancy.~   "
256417|NCT00194259|"~     This study will assess the effects of weight loss on sleep-disordered breathing (SDB) in 120~     obese, type 2 diabetics with obstructive sleep apnea (OSA) from four Look AHEAD sites.~     Changes in SDB will be compared between subjects randomized to weight loss (Lifestyle~     Intervention Group) versus non-weight loss (Diabetes Education and Support Group) conditions~     within the context of the Look AHEAD Study. Weight loss is frequently recommended for obese~     patients with OSA, but the empirical foundation for this recommendation is not well~     substantiated. Weight loss in obese apneics improves but does not eliminate SDB. Moreover,~     the degree of improvement is not correlated with the amount of weight loss. This study will~     assess SDB before treatment and at 1 and 2 years. We will also investigate clinical measures~     of fat distribution that may mediate the non-linear relationship between weight loss and~     improvements in SDB. Finally, we will examine the role of SDB in mediating changes in blood~     pressure associated with weight loss.~   "
256778|NCT00189475|"~     Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for~     the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50~     years.~   "
256420|NCT00194220|"~     This study is only collecting specimens from current patients of PENN Fertility Care.~      The purpose of this investigation is to assess if markers of oxidative stress that are known~     to be associated with other medical conditions can be detected in women undergoing~     infertility treatment and normal women of similar age. Oxidative stress may affect a woman's~     eggs or the follicular cells that surround and nurture them. Other markers of to be~     investigated include markers of cellular aging and DNA structural changes.~      Presence of these markers will be compared in blood and urine samples taken during~     infertility treatment, and follicular fluid at the time of IVF (if applicable).~   "
256421|NCT00194207|"~     The purpose of this study is to identify elements of a patient's demographics, history, and~     clinical presentation that may aid in differentiating between patients with an ectopic~     pregnancy, miscarriage, or normal intrauterine pregnancy. This study will also evaluate~     serial levels of human chorionic gonadotropin in the serum of these patients, as another way~     to make the diagnosis.~   "
256422|NCT00194194|"~     This study is designed to gain experience with the HealtheTech measurement system~     (BalanceLog) in the context of a clinical trial and to develop the related treatment~     protocols. In this study the aim is to evaluate two interventions, one moderate and the other~     intensive behavioral management. The development and evaluation of a HealtheTech protocol~     across these two treatment settings will provide useful data about implementation (e.g.,~     technical issues, clinical issues, participant satisfaction) and outcomes (weight loss,~     retention). These data can provide empirical and clinical support for practice guidelines.~   "
256423|NCT00194181|"~     Treating central venous dialysis catheter malfunction due to fibrin sheath formation with~     rt-PA(TPA)infusion will give equal patency rates in a more cost effective manner when~     compared to catheter exchange.~      Subjects are randomized to TPA infusion or catheter exchange and then followed for catheter~     function at the post treatment dialysis session, 30-day dialysis session and 60-day dialysis~     session. Costs and treatment results will be compared.~   "
256424|NCT00194168|"~     In an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will~     investigate the presence of specific molecular markers of ectopic pregnancy. The~     quantification of these (and other proteins) will be performed using the Ciphergen Protein~     Chip system where serum is sampled with a high-throughput system. The patterns of these peaks~     will be compared for those with a diagnosis of ectopic pregnancy and normal pregnancy. Later~     goals of the research will be to identify the actual proteins that correspond to the peaks~     which discriminate between the two clinical entitles. The goal is to identify a unique~     protein pattern or protein peak to distinguish a normal intrauterine pregnancy from that of~     an ectopic implanted gestation.~   "
256425|NCT00194155|"~     The purpose of this study is to determine if (recurrent) cytomegalovirus (CMV) infection of~     the mother results in pregnancy complications such as preterm delivery, severe preeclampsia,~     poor fetal growth, or stillbirth.~   "
256426|NCT00194142|"~     The purpose of this study is to determine if detection of cytomegalovirus (CMV) in amniotic~     fluid collected in the second trimester of pregnancy is associated with pregnancy~     complications such as preterm delivery or severe preeclampsia.~   "
256427|NCT00194129|"~     This study will determine the efficacy and safety of combination therapy with divalproex and~     lithium for treating mania in people with rapid cycling bipolar disorder and a substance~     abuse disorder.~   "
256428|NCT00194116|"~     Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression~     Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and~     females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II~     disorder and are currently experiencing an episode of major depression. Patients are~     randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the~     study for up to six weeks. This six-week double-blind treatment period is followed by an~     open-label treatment period of six months duration. This study is sponsored by Abbott~     Laboratories.~   "
256429|NCT00194103|"~     The purpose of this study is to determine the effectiveness of extended telephone monitoring~     for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized~     that telephone monitoring will produce better alcohol use outcomes relative to treatment as~     usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will~     produce better alcohol use outcomes over time relative to telephone monitoring plus feedback~     only.~   "
256430|NCT00194090|"~     A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis~   "
256431|NCT00194077|"~     The purpose of this study is to look at the safety and effectiveness of aripiprazole~     (abilify) in children with bipolar disorder and to examine whether or not patients that~     respond to initial mood stabilization benefit from continued pharmacotherapy.~   "
256432|NCT00194064|"~     Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in~     Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with~     Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing~     to spend initial 7 days in the hospital to observe response to medication. Patients must be~     refractory (intolerant or non-responsive) to treatment with lithium and valproate or~     carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli~     Lilly and Company.~   "
256433|NCT00194051|"~     Weight is a risk factor for knee osteoarthritis~      Knee osteoarthritis is associated with abnormal gait biomechanics~      Gait biomechanics are evaluated in gastric bypass patients before and after losing 100~     pounds.~   "
256434|NCT00194038|"~     The purpose of this research study is to analyze the effectiveness and tolerability of a new~     medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar~     disorder (manic-depressive illness).~   "
256435|NCT00194025|"~     The purpose of this research study is to analyze the effectiveness and tolerability of a~     medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who~     have schizophrenia.~   "
256436|NCT00194012|"~     The purpose of this study is to test the effectiveness and tolerability/safety of~     aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also~     have a parent with bipolar disorder and other family member with a mood disorder.~   "
256779|NCT00189462|"~     The objective of this pilot study is to evaluate the efficacy of treatment with montelukast~     as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)~   "
256437|NCT00193999|"~     Gastric emptying is delayed after cardiac surgery, but the efficacy of the nasogastric (NG)~     tube in preventing distension and reducing vomiting is unclear. Nasogastric (NG) tubes are~     routinely used in patients undergoing surgery. They are presumed to reduce postoperative~     nausea and vomiting (PONV) and to lessen the risk of aspiration by reducing residual gastric~     volumes; however, their insertion and use is not however without potentially serious~     complications. Existing literature does not address their efficacy in reducing PONV after~     cardiac surgery. However, current evidence suggests that up to 50% of patients in this group~     suffer significant nausea and vomiting. The objective of this study is to determine whether~     NG tubes should continue to be inserted routinely during cardiac surgery to reduce PONV.~   "
256438|NCT00193986|"~     Patient tolerance of pain from discharges of implantable cardioverter defibrillators (ICD's)~     is highly variable. It can be influenced by psychological factors, physical condition and the~     number of shocks delivered.~      It has been shown that cutaneous pain perception can be reduced by delivery of a weak , low~     voltage pulse (prepulse)prior to the delivery of a stronger shock.~      A prepulse delivered before a high voltage ICD shock will decrease discomfort compared to a~     shock of equal energy without a prepulse.~   "
256439|NCT00193973|"~     Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve~     similar survival outcomes but with reduced neurotoxicity compared to regimens using~     methotrexate with high dose radiotherapy.~   "
256440|NCT00193960|"~     Glaucoma drainage devices are usually placed in the superior quadrants. The superotemporal~     quadrant is usually the site of choice. However, when the upper fornix is scarred and~     especially when conjunctiva is two fibrotic to enable adequate coverage of tube with a~     scleral or other patch graft, some surgeons place the tube in one of inferior quadrants.~   "
256441|NCT00193947|"~     Hypothesis~      Nevirapine resistance developed in women and infants in the HIVNET 006 and 012 cohorts as a~     consequence of use of an agent with a long t½ as monotherapy in individuals with high viral~     loads.~      Objective 1 To demonstrate that Nevirapine resistance does not develop in HIV infected~     patients when used as part of triple antiretroviral combination therapy between the~     initiation of treatment and suppression of HIV RNA to <1000 copies/ml.~      Objective 2 To demonstrate that resistance to nevirapine does not develop when patients with~     suppressed HIV RNA discontinue combination antiretroviral therapy which contains nevirapine.~   "
256442|NCT00193934|"~     The researchers propose that it may be corpus invasion, rather than tumour volume per se,~     which is one of the important determinants of ultimate outcome in cervix cancer. The aim of~     the proposed prospective, multicentre study, is to confirm the results of our retrospective~     studies, specifically that corpus invasion or tumour volume or both contribute important~     prognostic information over and above that provided by the currently used International~     Federation of Gynecology and Obstetrics (FIGO) staging system. A successful outcome would~     have important implications for the staging, and management as well as the biologic~     understanding of the behaviour of cervical cancer.~   "
256443|NCT00193921|"~     The study compares 2 different methods of combined chemotherapy and radiotherapy for the~     treatment of localised lung cancer in patients not suitable for surgery.~      Hypothesis(es) to be tested:~        1. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine +~          high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting~        2. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine +~          high dose palliative radiotherapy in terms of feasibility in a multi-institutional~          setting~        3. Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity~          profile relative to gemcitabine + high-dose palliative radiotherapy~   "
256444|NCT00193908|"~     This study has patients using two different moisturising creams during radiation therapy~     after mastectomy. These are Cavilon and sorbolene. It is hypothesised that skin reactions may~     be reduced by the Cavilon cream compared to sorbolene.~   "
256445|NCT00193895|"~     The primary objective of the trial is to determine, in patients who have undergone surgery~     with curative intent for high-risk CSCC of the head and neck, whether there is a difference~     in time to loco-regional relapse between patients treated with post-operative concurrent~     chemo-radiotherapy ,consisting of Carboplatin, and post-operative radiotherapy alone. The~     target sample size for the trial is 266 patients and will take 3-4 years to accrue, based on~     an anticipated accrual of 80 patients/year. A further 2 years follow up is required.~   "
256446|NCT00193882|"~     To compare the treatment of gullet cancer with radiotherapy alone and assess the advantage~     and toxicity of adding chemotherapy. The hypothesis to be tested is as follows: That the~     addition of chemotherapy to a short course of radiation treatment improves the proportion of~     patients who achieve relief of dysphagia and improves quality of life compared to radiation~     alone in patients with advanced oesophageal cancer.~   "
256447|NCT00193869|"~     The study aimed to pilot the viability of a full scale randomised comparison of 2 steroid~     doses in malignant spinal cord compression, to establish safety of high dose dexamethasone in~     this setting in Australia, to test web registration and randomisation and to compare~     different functional outcome measures.~   "
256448|NCT00193856|"~     The principal objectives of the RADAR trial is to address the hypotheses; 1) that 18 months~     androgen deprivation in conjunction with radiotherapy is superior to 6 months androgen~     deprivation prior to and during radiotherapy; 2) that 18 months Bisphosphonate therapy will~     prevent bone loss caused by androgen deprivation therapy and further reduce relapse risk by~     impeding the development of bony metastases.~   "
256449|NCT00193843|"~     To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant~     radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6~     fractions / week instead of 5 fractions / week improves local-regional control and / or~     overall survival in high risk, locally advanced, resectable, squamous cell carcinoma of oral~     cavity.~   "
256471|NCT00193557|"~     This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the~     treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly~     schedule of bortezomib is effective in producing responses in patients with stable disease or~     progression after weekly bortezomib~   "
256719|NCT00190268|"~     Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in~     patient's multiple sclerosis.~      In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded~     study is performed.~   "
256450|NCT00193830|"~     Radiation therapy still remains mainstay of treatment for patients with carcinoma cervix in~     advanced stages. Conventional treatment with radiation therapy includes a combination of~     external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary~     brachytherapy treatment is the time-tested modality of brachytherapy with sound~     radiobiological bases. But high dose rate brachytherapy is a relatively new alternative. In~     low dose rate brachytherapy the staff receives some radiation while in the high dose rate~     brachytherapy procedure complete protection to staff can be achieved as the treatment is done~     with remote afterloading technique. The high dose rate brachytherapy is possible as Out~     Patient Department procedure. Few clinical trials have proven the feasibility and efficacy of~     high dose rate brachytherapy in carcinoma of cervix. However, there is no concrete evidence~     especially in developing countries for the change of practice to HDR brachytherapy. Hence, at~     Tata Memorial Hospital with an aim to assess the efficacy, feasibility, early and late~     complications of high dose rate brachytherapy in contrast with low dose rate brachytherapy we~     propose this study.~   "
256451|NCT00193817|"~     Surgery is the standard treatment for esophageal (food pipe) cancer. Esophageal cancer is~     known to spread to the lymph nodes (glands) adjacent to the esophagus. The extent of lymph~     nodes that need to be removed along with removal of the esophagus is a controversial topic.~     The basic surgery will remain the same i.e., the foodpipe in the chest will be removed and a~     new substitute will be created from the stomach and joined to the foodpipe in the neck. This~     will involve incisions in the chest, abdomen and neck. We intend to compare two types of~     lymphadenectomy (removal of lymph nodes) - the two field lymphadenectomy, whereby the lymph~     nodes in the abdomen and the lower half of the chest will be removed and three field~     lymphadenectomy, wherein lymph nodes in the abdomen, the whole chest and the lower neck will~     be removed. Both these procedures are practised widely worldwide and there is no definite~     scientific evidence showing the superiority of either of them. We are conducting this study~     to see whether one of these procedures is superior to the other. Seven hundred patients are~     expected to participate in this study.~   "
256452|NCT00193804|"~     A study to evaluate the efficacy of Intensity Modulated Radiation Therapy (IMRT) as compared~     to Standard Conventional Radiotherapy Alone in the treatment of carcinoma cervix. Concomitant~     Weekly Cisplatin chemotherapy will be given as a routine, which is a standard of care today~     for early stage cervical cancers including stage IIB. The benefits of using IMRT in reducing~     radiation-induced toxicity are well known. Since this treatment modality has not yet been~     validated and studied in a randomized trial setting, the present study is being undertaken.~     The study arm of IMRT has the potential to reduce the toxicities by 15-20%, but is associated~     with labor intense procedure requiring many hospital visits before actual start of treatment.~   "
256453|NCT00193791|"~     A study to evaluate the efficacy of concomitant chemoradiation as compared to radiotherapy~     alone. Concomitant chemoradiation is not a new treatment modality for carcinoma cervix.~     Studies have shown improvement in survivals with chemoradiation, but majority of the patients~     was in early stages. Since this treatment modality has not been tested adequately in advanced~     stages in our setting, the present study is being undertaken. The study arm of chemoradiation~     has the potential to improve the survivals by 10%, but is associated with additional 5% risk~     of toxicities, which are treatable. In the study arm, apart form the standard radiotherapy~     treatment, you will receive weekly chemotherapy injections (Cisplatin) during external~     radiation therapy. The study arm is associated with additional 5% acute hematological and~     gastrointestinal toxicities, which are treatable with medications, blood transfusions,~     modifications in the ongoing treatment etc.~   "
256454|NCT00193778|"~     Traditionally metastatic breast cancer patients are not offered loco-regional treatment~     except in cases of fungation or bleeding. However, scientific evidence for such omission of~     loco-regional treatment in metastatic breast cancer patients is lacking. On one hand, studies~     have shown that removal of primary tumor at times leads to complete disappearance of~     metastases and improvement in survival in renal cell carcinoma patients. However, such~     studies have never been performed in other solid tumors. On the other hand, there is a strong~     body of evidence in experimental settings that show that removal of primary tumor allows~     growth of metastasis. There is lack of similar data in humans in clinical settings. Offering~     loco-regional treatment in metastatic breast cancer patients in a setting of randomized~     controlled trial will help in improving survival of such patients and understanding the~     natural history of breast cancer.~   "
256455|NCT00193765|"~     Cervical nodal metastasis is the single most important prognostic factor in head and neck~     cancers. Appropriate management of the neck is therefore of paramount importance in the~     treatment of these cancers. While it is obvious that the positive neck must be treated,~     controversy has always surrounded the clinically node negative neck with respect to the ideal~     treatment policy.The situation is difficult with regards to early cancers of the oral cavity~     (T1/T2). These cancers are usually treated with surgery where excision is through the~     per-oral route. Elective neck dissection in such a situation is an additional surgical~     procedure with its associated costs, prolonged hospitalization and may be unnecessary in as~     high as 80% of patients who finally turn out to be pathologically node negative. Should the~     neck be electively treated or there be a wait and watch policy? Current practice is that the~     neck is always addressed whenever there is an increased propensity to cervical metastasis or~     when patient follow-up is unreliable.~      There is clearly a need therefore for a large randomized trial that will resolve the issue~     either way once and for all.~      Primary Objective:~      To demonstrate whether elective neck dissection (END) is equal or superior to the wait and~     watch policy i.e.~      therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2~     cancers of the oral cavity.~      Secondary Objective:~        1. Does Ultrasound examination have any role in the routine initial workup of a node~          negative patient?~        2. How are patients ideally followed up -does sonography have a role or is clinical~          examination sufficient.~        3. Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate~          -Is there a correlation~        4. Identify histological prognostic factors in the primary that may help identify a sub-set~          of patients at an increased risk for cervical metastasis.~   "
256456|NCT00193752|"~     18F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging has been extensively~     used in the evaluation of various malignancies and is rapidly being recognized as a mandatory~     investigations. 18F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging has~     also been tried in cervical cancers with excellent results for detection of both pelvic and~     extra-pelvic disease in terms of sensitivity and specificity. Till date, PET Imaging has been~     reported to have highest sensitivity and specificity for detection of disease and treatment~     failures compared to other non-invasive investigations available. Treatment decisions~     (Localized RT Vs Extended RT) will be according to the results of PET Scans. The treatment~     response, outcome and follow-up will be labelled according to the PET Scan results and will~     be directed for treatment accordingly.~   "
257244|NCT00183235|"~     The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer)~     is effective in reducing of alcohol craving compared to placebo.~   "
256457|NCT00193739|"~     Carcinoma cervix is a common malignancy in women in developing countries including India. The~     standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant~     chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a~     meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant~     chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these~     patients. However NACT-Surgery approach has never been compared to the current standard of~     concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3~     courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to~     IIB squamous cell carcinoma of the uterine cervix.~   "
256458|NCT00193726|"~     One of the basic principles of cancer chemotherapy is that these drugs act exclusively or~     mainly on cells in cycle. Estrogens have been shown to increase the fraction of breast cancer~     cells in cycle. Tamoxifen on the other hand, decreases the proliferative fraction and has~     been shown to negatively impact on the results of adjuvant chemotherapy in breast cancer when~     given concomitantly. A number of previous studies have attempted estrogenic recruitment of~     cancer cells (into cell cycle) to increase the efficacy of chemotherapy in locally advanced~     and metastatic breast cancer. Although some studies showed an increase in response rates in~     the recruitment arm, there was no benefit in time to progression or survival in any of the~     studies. These results may have been due to the inadequate sample size of the studies and~     advanced stage disease (with presumably higher fraction of inherently chemoresistant cells).~     The present study is designed to test the hypothesis that estrogenic recruitment of~     micrometastatic disease in operable breast cancer will increase the efficacy of standard~     adjuvant chemotherapy after surgery. The intervention arm of the study will involve~     administration of short duration estrogen prior to each cycle of adjuvant chemotherapy. The~     end-points are disease free and overall survival.~   "
256459|NCT00193713|"~     Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.~   "
256460|NCT00193700|"~     Measure and evaluate the level of testosterone in blood, and determine the safety and~     tolerability following daily applications of testosterone gel. Subjects who complete this~     trial may participate in the extension part (UMD-01-080E).~   "
256461|NCT00193687|"~     Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.~     Extension to study S154.3.001.~   "
256462|NCT00193674|"~     The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to~     non-inflammatory cytokines in women suffering from habitual abortion treated with~     dydrogesterone (Duphaston).~   "
256463|NCT00193661|"~     This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty~     adolescents. Subjects who complete this trial may enter a 3 month extension study~     (UMD-01-090E).~   "
256464|NCT00193648|"~     The current management of primary FSGS is predicated on the assumption that the disease is~     caused by an immune-mediated disturbance in glomerular barrier function. Therefore, most~     treatment protocols have involved immunosuppressive drugs given singly or in combination.~     However, the efficacy of this type of therapy has been disappointing and the long-term~     prognosis for renal survival in patients with resistant FSGS is poor. An alternative approach~     that targets the fibrosis pathway may represent a novel approach to the treatment of~     resistant FSGS. In this R21, the investigators will test the hypothesis that two novel agents~     - a tumor necrosis factor-alpha (TNF-α) antagonist and a peroxisome proliferator activator~     receptor-gamma (PPARγ) agonist - can be administered safely to patients with resistant FSGS.~     In the R21 feasibility/pilot phase, pharmacokinetic studies will be conducted to assess the~     impact of proteinuria on the kinetics of the novel drugs in children and adults.~      Specific Aim #1: To assess the safety and tolerability of two novel drugs - a TNF-α~     antagonist and a PPARγ agonist - in patients with resistant FSGS.~      Specific Aim #2: To conduct a pharmacokinetic (PK) assessment of the selected agents to~     enable selection of medication regimens for investigation in a randomized Phase II study.~   "
256465|NCT00193635|"~     Congenital or hereditary structural anomalies of the genitourinary tract account for~     approximately half of all cases of end stage renal disease in the pediatric population.~     Despite optimal medical management, when the GFR falls below 50 ml/min/1.73 M2, nearly 40% of~     affected children will require dialysis or a renal transplant within 2 years. At present,~     there is no specific treatment for patients with congenital uropathies that can retard the~     progressive loss of kidney function and forestall the need for renal replacement therapy.~      There is evidence in experimental animals and in patients with chronic renal failure (CRF)~     that immunoeffector mechanisms are activated within the renal parenchyma. Infiltration of the~     kidney by macrophages, monocytes, and lymphocytes, activation of renal tubular epithelial~     cells, and release of pro-inflammatory cytokines result in fibrosis and irreversible organ~     damage.~      Mycophenolate mofetil (MMF) is a new immunosuppressive agent that is used to prevent acute~     rejection in kidney transplant recipients. It attenuates renal damage in the remnant kidney~     model of CRF in which there is no primary immunological injury. Therefore, this pilot study~     is designed to test the hypothesis that immunosuppressive treatment with MMF in children with~     structural causes of CRF will be safely tolerated and that this therapy will retard~     progressive decline in renal function.~      Patients with congenital uropathy, 3-16 years of age and with a GFR less than 50 ml/ml/1.73~     M2, will be treated with MMF for 24 months. The two primary endpoints are: (1) safety and~     tolerance of the drug; and (2) need for dialysis or kidney transplantation. It is anticipated~     that the MMF will be free of significant toxicity and that administration of the drug will~     reduce the frequency of progression to end stage renal disease from 38% to 19%. Patients will~     be followed at 3-month intervals and they will undergo serial assessment of proteinuria,~     estimated GFR and iothalamate clearance, urinary cytokine excretion, urine flow cytometry,~     and immunologic testing.~      The significance of this pilot study is that it may provide evidence in support of a~     randomized, double-blind, placebo-controlled trial of immunological treatment of congenital~     structural causes of CRF in children~   "
256466|NCT00193622|"~     This trial will investigate the combination of bevacizumab, and erlotinib in patients with~     adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and~     erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This~     trial will be one of the first clinical trials to evaluate a combination of targeted agents~     in the treatment of a solid tumor.~   "
256467|NCT00193609|"~     In this phase II trial, we will evaluate the feasibility and efficacy of the~     oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy~     regimen for the treatment of carcinoma of unknown primary site. Patients who are relapsed~     after a previous response to treatment will be eligible, as well as those who were refractory~     to first-line therapy.~   "
256468|NCT00193596|"~     In this randomized trial, we will investigate the activity and toxicity of two active~     regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by~     ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.~   "
257458|NCT00180245|"~     The purpose of the study is to describe the regional and global FDG-kinetics in head and neck~     cancer during percutaneous radiation therapy.~   "
256472|NCT00193544|"~     In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of~     patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with~     thalidomide. Although both drugs have a similar mechanism of action, it is likely that the~     mechanisms may be additive or synergistic. Since neither drug produces much myelosuppression,~     this combination regimen should be tolerable in patients with compromised marrow function due~     to involvement with myeloma and/or previous cytotoxic chemotherapy~   "
256473|NCT00193531|"~     carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients~     with poorly differentiated neuroendocrine carcinomas. We hope to identify a standard~     treatment for this unusual group of patients who are not usually eligible for clinical~     trials.~   "
256474|NCT00193518|"~     Additional active agents are needed to further improve the treatment of patients with~     CLL/SLL. Increasing information exists regarding the activity of arsenic trioxide in other~     hematologic malignancies. Since arsenic trioxide produces mild to moderate myelosuppression~     and is not as immunosuppressive as other available agents, it may be an additional treatment~     option for CLL/SLL. This study will evaluate the feasibility and toxicity of arsenic trioxide~     in patients with relapsed or refractory CLL/SLL~   "
256475|NCT00193505|"~     In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of~     treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with~     relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.~   "
256476|NCT00193492|"~     The purpose of this study is to assess the feasibility, efficacy and safety of adding~     bevacizumab to rituximab compared to rituximab alone in patients with previously treated~     follicular non-hodgkin's lymphoma (NHL) whose disease has progressed following at least one~     previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.~   "
256477|NCT00193479|"~     The purposes of this trial are to decrease toxicity and improve treatment effectiveness~     elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone,~     vincristine, and prednisone with concurrent administration of rituximab it is likely to be as~     effective as longer programs, and will certainly be better tolerated by this patient group.~     The addition of maintenance therapy may result in substantial prolongation of remission~     duration.~   "
256478|NCT00193466|"~     In this multicenter trial, we will investigate the use of fludarabine plus rituximab,~     followed by Campath-1H, in previously untreated patients with CLL/SLL. Patients who are~     elderly, or who are considered unlikely to tolerate this combination therapy well, will~     receive single agent rituximab followed by Campath-1H.~   "
256479|NCT00193453|"~     This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well~     tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer~     (NSCLC), in combination with a novel agent cetuximab.~   "
256480|NCT00193440|"~     In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab~     tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma.~     Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination~     of rituximab and short course chemotherapy will allow the use of additional active agent with~     a unique mechanism of cytotoxicity. In addition, debulking of lymphoma prior to 90Y Zevalin~     administration may minimize the myelotoxicity of this agent.~   "
256481|NCT00193427|"~     This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively~     non-toxic combination in advanced NSCLC. This study will help to better define optimal~     preoperative regimens for patients with resectable NSCLC. Since both of these drugs are~     potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may~     produce not only radio-sensitization, but also considerable antitumor efficacy.~   "
256482|NCT00193414|"~     This study is designed to study the role of an active and well-tolerated non-platinum agent,~     gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced~     NSCLC. This study will serve to define the role of next generation agents in a new~     combination regimen in the treatment of advanced NSCLC. This combination regimen may~     ultimately be important in further expanding treatment options for patients while improving~     survival, quality of life, and symptom control compared with platinum-based combination~     regimens - and with acceptable toxicity.~   "
256483|NCT00193401|"~     In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line~     treatment of elderly and/or poor performance status patients with extensive stage small cell~     lung cancer. Patients eligible for this trial will be those considered poor candidates for~     standard combination chemotherapy or other investigational regimens~   "
256484|NCT00193388|"~     In this phase II trial, we will evaluate the weekly schedule of topotecan in the second-line~     treatment of patients with small cell lung cancer~   "
256485|NCT00193375|"~     In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial~     treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with~     bevacizumab, in patients with limited stage small cell lung cancer.~   "
256486|NCT00193362|"~     The purpose of this study is to compare the effectiveness of the three-drug combination~     paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and~     vinorelbine in patients with advanced Non-Small Cell Lung Cancer~   "
256487|NCT00193349|"~     This study will evaluate combination chemotherapy for patients with extensive stage small~     cell lung cancer combined with the potentially useful growth inhibiting effects of Gleevec.~   "
256488|NCT00193336|"~     Because of the demonstrated single agent activity and excellent tolerability in patients with~     refractory non-small cell lung cancer, ZD1839 may be of benefit in the first-line treatment~     of patients with advanced non-small cell lung cancer who have poor performance status. In~     this phase II trial, we will investigate the single agent activity of first-line ZD1839 in~     patients with advanced non-small cell lung cancer with poor performance status~   "
256489|NCT00193323|"~     In this randomized trial, we attempt to further define optimal palliative chemotherapy for~     elderly patients with advanced non-small cell lung cancer by comparing single agent treatment~     with weekly docetaxel versus combination therapy with weekly docetaxel plus gemcitabine.~   "
256562|NCT00192361|"~     To assess whether CAIV-T was transmitted from vaccinated children to their unvaccinated~     contacts in a day care setting; and if so, to estimate the rate of transmission.~   "
256490|NCT00193310|"~     In this phase II study, we plan to evaluate several novel components of therapy. In patients~     with potentially resectable stages IIB (T3N0) and IIIA we will compare weekly paclitaxel and~     carboplatin with concomitant radiation therapy versus weekly paclitaxel and every 4 week~     carboplatin in the preoperative (neoadjuvant) setting. For patients with potentially~     resectable stage IB, IIA and IIB (T2N1) tumors, weekly paclitaxel and every 4 week~     carboplatin will be given pre-operatively (neoadjuvant). The feasibility of resection will be~     evaluated in the neoadjuvant group of patients. The continued study of concurrent radiation~     therapy with weekly paclitaxel and carboplatin will be evaluated in those patients with stage~     IIB (T3N0) and IIIA disease who initially had resection (adjuvant setting). Lastly, weekly~     paclitaxel and carboplatin every 4 weeks will be evaluated as an adjuvant program in patients~     who had completely resected stage IB, IIA and IIB (T2N1).~   "
256491|NCT00193297|"~     The purpose of this study is to evaluate the feasibility and toxicity of the combination of~     paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV~     epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary~     evaluation of the efficacy of this three drug regimen in the initial treatment of these~     patients.~   "
256492|NCT00193284|"~     Although gefitinib has been combined successfully with various chemotherapeutic regimens with~     minimal increase in overall toxicity, experience with concurrent radiation therapy is~     limited. In this trial, we will evaluate the feasibility, toxicity, and effectiveness a novel~     combination of chemotherapy, radiation therapy, and gefitinib.~   "
256493|NCT00193271|"~     This trial will evaluate the feasibility, toxicity, and efficacy of docetaxel/estramustine,~     as in the adjuvant therapy of patients with high-risk prostate cancer after definitive local~     therapy.~   "
256494|NCT00193258|"~     This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition~     of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects.~     Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been~     demonstrated, the mild to moderate side effects of all of these agents are not predicted to~     cause prohibitive toxicity. A brief phase I portion will be included in this trial, to~     optimize doses of the 3 agents prior to proceeding with the phase II trial.~   "
256495|NCT00193245|"~     In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with~     intravenous docetaxel in the second-line treatment of patients with non-small cell lung~     cancer.~   "
256496|NCT00193232|"~     Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for~     patients with advanced hormone-refractory prostate cancer.~   "
256497|NCT00193219|"~     This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin,~     oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal~     cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of~     advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an~     earlier treatment setting in combination with optimal chemotherapy regimens is an important~     emerging question.~   "
256498|NCT00193206|"~     In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the~     biweekly pegfilgrastim support, in order to further improve upon the effectiveness and~     favorable toxicity of this triplet.~   "
256499|NCT00193193|"~     In this trial we will investigate how this three-drug regimen may be improved, both with~     respect to efficacy and toxicity, by making some modifications in the dosing and schedule in~     the treatment of patients with hormone refractory prostate cancer.~   "
256500|NCT00193180|"~     This trial evaluates the novel combination of docetaxel with imatinib as first or second line~     therapy in advanced breast cancer with the aim of achieving higher effectiveness and~     potentially reducing side effects.~   "
256501|NCT00193167|"~     This non-randomized phase II study is designed to assess the response rate and toxicity of~     weekly topotecan as second-line treatment in patients with relapsed or refractory metastatic~     colorectal cancer.~   "
256502|NCT00193154|"~     In this phase II trial, we plan to evaluate the combination of Tarceva and Avastin in the~     treatment of patients with metastatic renal cell carcinoma. This trial will be one of the~     first phase II trials to evaluate a combination of targeted agents in the treatment of a~     common solid tumor with a strong biologic rationale based on Cancer Biology~     (VHL/HIF/VEGF/EGFr).~   "
256503|NCT00193141|"~     In this randomized study, we plan to address the important question of optimum local~     treatment for patients with localized esophageal cancer. All patients will receive our~     previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU,~     and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be~     randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy,~     along with one additional course of chemotherapy.~   "
256504|NCT00193128|"~     In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used~     concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of~     the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we~     will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs~     (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the~     3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the~     3-drug combination is considered too toxic, the phase II study will proceed with~     docetaxel/oxaliplatin in combination with radiation therapy.~   "
256505|NCT00193115|"~     This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by~     doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of~     women with node positive and high risk breast cancer~   "
256506|NCT00193102|"~     The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug~     administration, and the possibility for antitumor synergy make exploration of this~     combination regimen attractive in women with previously treated metastatic breast cancer.~     This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research~     Network, a multicenter, community-based clinical trials group.~   "
256507|NCT00193089|"~     In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine~     combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is~     well tolerated with minimal myelosuppression, so that it is likely that fully efficacious~     doses of all three drugs can be administered~   "
256508|NCT00193076|"~     Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is~     synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent~     clinical data suggest that the combination of gemcitabine with platinum is an active regimen~     in metastatic breast cancer. This study will test the combination of gemcitabine with~     carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression~     will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.~   "
256509|NCT00193063|"~     Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as~     well as the additive activity observed for gemcitabine administered in combination with~     trastuzumab, the clinical activity of the combination of gemcitabine administered with~     trastuzumab represents an exciting and ideal combination to further evaluate in Her 2~     over-expressing metastatic breast cancer patients.~   "
256510|NCT00193050|"~     Treatment strategies that include induction chemotherapy have several potential advantages:~     early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging~     of both the primary tumor and regional lymphatic metastases, making breast conservation an~     option for many. The aim of the present study is to determine the efficacy and toxicity of~     induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel,~     in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the~     upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new~     agents and combination of agents are likely to have the greatest potential impact.~   "
256511|NCT00193037|"~     The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will~     be evaluated as first line treatment in metastatic breast cancer patients, with subsequent~     crossover to the opposite arm at disease progression or patient intolerance. We will explore~     this as well as any possible cross resistance between these two agents.~   "
256512|NCT00193024|"~     The epirubicin/docetaxel combination is one of the most active and best tolerated~     taxane/anthracycline combinations. In this phase II trial, we will further evaluate the~     feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when~     administered as first-line treatment for metastatic breast cancer.~   "
256513|NCT00193011|"~     This trial will evaluate the effectiveness of standard adjuvant treatment with CMF~     chemotherapy versus treatment with weekly docetaxel in patients with high-risk breast cancer~     who are 65 years of age and older or are poor candidates for anthracycline-containing~     regimens. This CMF regimen has decreased dose intensity and may be slightly less active in~     patients with metastatic breast cancer; however, the patient population in this trial has~     tolerated more intensive CMF regimens poorly in other trials.~   "
256514|NCT00192998|"~     The aim of this project is to examine the serotonergic transmitter system using functional~     imaging of the brain (positron emission tomography [PET]) to gain knowledge about early~     pathophysiological changes in Alzheimer's dementia and mood disorders.~   "
256515|NCT00192985|"~     Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can~     reduce the number of urinary tract infections.~   "
256516|NCT00192972|"~     Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have~     been proven effective in the treatment of atrial fibrillation.~      In this study patients with symptomatic paroxystic or persistent AF were randomised to one of~     the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence~     of left atrium-PV conduction.~   "
256517|NCT00192959|"~     The primary objective was to explore the feasibility of inhaled xenon for sedation in terms~     of its effect on postoperative cognitive function in elderly, in comparison with the~     postoperative cognitive function found after IV propofol sedation in the same population.The~     secondary objectives were designed to assess the feasibility of xenon sedation in terms of~     its effects on different neuropsycho-logical test variables, vital signs, sedation levels and~     safety in elderly orthopaedic subjects.~   "
256518|NCT00192946|"~     In patients with broad QRS complexes on electrocardiogram (ECG), the delayed electrical~     activation of the left heart chamber will cause abnormal contraction.This has been shown to~     be possible to treat by a special pacemaker treatment which includes pacing of the left heart~     chamber (= CRT treatment).~      In this study the researchers will investigate the effect of acute CRT treatment in the early~     phase after open heart surgery.~   "
256519|NCT00192933|"~     The purpose is to evaluate and improve NovoSeven treatment practice done according to our~     guidelines~   "
256520|NCT00192920|"~     The purpose is to evaluate and improve transfusion practice~   "
256521|NCT00192907|"~     The purpose of this study is to investigate the relationship between trauma, the immune~     system, biochemical changes in the first 24 h and subsequent complications and mortality~   "
256522|NCT00192894|"~     The purpose of this study was to evaluate the changes in heart function during onset of~     spinal anesthesia using a new and less invasive method, the LidcoTMplus.~   "
256523|NCT00192881|"~     The purpose of this study is to evaluate the clinical and angiographic outcome of~     implantation of stents eluting or not eluting Sirolimus in patients with complex coronary~     artery lesions suitable for percutaneous coronary intervention.~   "
256524|NCT00192868|"~     The purpose of this study is to evaluate the clinical, echocardiographic and angiographic~     outcome of distal protection in the infarct related coronary artery and implantation of drug~     eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated~     acutely with percutaneous coronary intervention.~   "
256525|NCT00192855|"~     This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment~     can be beneficial in schizophrenic patients with negative symptoms.~   "
256526|NCT00192842|"~     The study hypotheasis is that curcumin, a natural compound with a potent antiproliferative~     effect, can improve the efficacy of the standard chemotherapy gemcitabine in patients with~     advanced pancreatic cancer. That is why the patients are given a daily oral dose of 8 gr of~     curcumin along the chemotherapeutic protocol of weekly gemcitabine.~   "
256527|NCT00192829|"~     The association between cancer and thrombosis is well known and the occurrence of thrombotic~     complications is commonly associated with poor prognosis. The aim os this study is to~     determine the possible value of hypercoagulable parameters as prognostic parameters in~     advanced non-small cell lung carcinoma (NSCLC).~   "
256563|NCT00192348|"~     Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine.~   "
256528|NCT00192816|"~     The purpose of this study is to determine response to pain in Alzheimer's disease.We plan to~     study the effect of diffuse noxious inhibitory controls(counterirritation phenomenon)and the~     autonomic nervous system reaction(reflected by the heart rate) in Alzheimer's disease. The~     study's hypothesis is that pain perception and autonomic nervous system reaction are altered~     in Alzheimer's disease.~   "
256529|NCT00192803|"~     This feasibility study is designed to examine modulation of the relative activities of ACE~     and ACE2 in diabetic patients following treatment with the angiotensin type 1 receptor (AT1R)~     antagonist, Candesartan.~      This study will provide a closer insight to the possible involvement of the renin-angiotensin~     system (RAS)-related enzymatic components in development or attenuation of vascular~     pathogenesis.~   "
256530|NCT00192790|"~     To explore whether reduced systemic pain perception in response to painful stimuli and~     personality pain related variables characterizes silent MI patients.~   "
256531|NCT00192777|"~     Hypothesis: Radiosensitization using Xeloda should improve the rate of complete pain relief.~      Primary Objective:~        -  To determine the frequency of pain relief for the proposed regimen.~      Secondary Objective(s):~        -  To determine the duration of pain relief and narcotic relief for the proposed regimen.~        -  To determine the frequency of narcotic relief for the proposed regimen.~        -  To determine the toxicity of concurrent UFT and radiotherapy in patients with bone~          metastases.~   "
256532|NCT00192764|"~     The study hypothesis is that intensification of CHOP by dose escalation of the most active~     drugs in the combination will improve treatment outcome. Patients with diffuse large-cell~     lymphoma are treated by high cyclophosphamide containing CHOP. The planned dose is 3000 mg/m2~     which is 4 times the atandard one. Only 4 cycles are given.~   "
256533|NCT00192751|"~     The purpose of this study is to determine the benefit and impact on relapse~     prevention,adherence to treatment and general health indices of participation in~     psycho-eduational group intervention among psychiatric patients with severe mental~     illness,recently discharged from inpatient services.~   "
256534|NCT00192738|"~     Several studies have shown the importance of Telephone follow-up in reducing hospital~     readmissions for heart failure. Therefore, we aimed in this cohort to investigate whether~     telephone follow-up with patients discharged from the general internal department improves~     patients' satisfaction, increases compliance to treatment and reduces adverse effects.~     Patients are recruited from the department of general internal medicine who gave informed~     consent and could communicate. Patients are interviewed by during hospital stay, one and~     three months later. This group will be compared with patients that are not interviewd by~     phone aftert hospital discharge.~   "
256535|NCT00192725|"~     Serotonin (5-HT) is important in mood regulation and is believed to play a major role in the~     pathophysiology of major depression (MD). Selective serotonin reuptake inhibitors (SSRIs) are~     currently the most widely used drugs for the treatment of depression. Patients with bipolar~     disorder (BD) who are treated for depression with SSRIs might develop mania, which is~     believed to be triggered by antidepressant treatment. Rapid tryptophan depletion (RTD) has~     been shown to induce transient depressive symptoms in remitted depressed patients treated~     with SSRIs. In remitted manic patients treated with lithium, RTD does not seem to have~     clinical effects. However, RTD was not studied in acutely manic patients and could~     theoretically have antimanic properties. In this double blind randomized placebo controlled~     study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated~     for its antimanic properties and potential use as augmentation to drug treatment in acute~     mania.~   "
256536|NCT00192712|"~     The study hypothesis is that chemoradiation based on 2 drugs will improve local control and~     long-term survival in patients with locally advanced pancreatic cancer. That is why~     gemcitabine and irinotecan are combined in an induction phase of 2 months and then this~     IrinoGem combination is given for 3 more cycles, in reduced doses,concurently with~     irradiation.~   "
256537|NCT00192699|"~     This is a 10 year follow-up investigation of patients who have underwent total hip~     arthroplasty with a cemented Bimetric stem.~   "
256538|NCT00192686|"~     Cultures from total knee arthroplasties, obtained a.m. Kamme-Lindberg in revision cases.~   "
256539|NCT00192673|"~     The purpose of this study is~        1. to determine the correct dose for intramuscular administration~        2. to compare the frequency of antibody formation after intramuscular administration of~          native E.coli asparaginase and PEG-asparaginase during two treatment courses in the~          treatment of childhood lymphoblastic leukemia~   "
256540|NCT00192660|"~     This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (PI)~     containing and non-PI containing antiretroviral regimens on the expression of adipocyte~     specific genes, protein levels and cellular structure in HIV-infected individuals, naive to~     therapy, who are starting therapy for the first time.~   "
256541|NCT00192647|"~     This study will evaluate the addition of a higher-dose induction treatment period with~     peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with~     PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive~     participants with CHC, genotype 1 infection.~   "
256542|NCT00192634|"~     Combination antiretroviral therapy for the treatment of HIV has a high pill burden. Two~     dual-tablets, abacavir-lamivudine and tenofovir-emtricitabine, are now licensed in the United~     States and will be available in Australia in December 2005. Data available suggest that the~     potency of these tablets are similar in controlling replication of the HIV virus, but not~     have not been directly compared in regard to clinically significant toxicities. We therefore~     aim to compare the overall safety and efficacy of the two dual-tablets over a 2 year period~     in HIV infected adults. We hypothesise that the two dual-NRTI treatments will be similar in~     efficacy and safety.~   "
256543|NCT00192621|"~     This is a randomised study of the effect of treatment with Combivir (zidovudine [AZT] and~     lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the~     development of abnormalities in lipid and glucose metabolism in HIV negative healthy~     subjects.~   "
256564|NCT00192335|"~     -  Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist~        -  Secondary objective of this study is to assess the safety and tolerability of CAIV-T~          compared to FluMist~   "
257140|NCT00184613|"~     This trial is conducted in Europe. The objective of the study is to investigate the effect~     and safety of continously basal delivered insulin aspart given by a pump versus once daily~     injection of insulin glargine.~   "
256544|NCT00192608|"~     Saquinavir and Atazanavir are drugs used in combination therapy to treat HIV disease.~     Saquinavir is currently available in a 200 milligram capsule. Most individuals currently on~     saquinavir require to take 5 tablets twice a day. In an attempt to reduce this number of~     pills, a new capsule has been developed containing 500 milligrams of saquinavir. This study~     will assess: i) blood drug levels in individuals taking both saquinavir formulations, ii)~     blood drug levels in individuals taking both saquinavir formulations when given with~     atazanavir, iii) 48 weeks of follow up for individuals receiving the new saquinavir~     formulation with atazanavir as HIV therapy.~   "
256545|NCT00192595|"~     The purpose of the study is to compare the effectiveness of 3 different treatment regimens in~     reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B~     (co-infection)~   "
256546|NCT00192582|"~     A new treatment for indigenous people with mental illness in remote communities has been~     developed. The study hypothesis is that this new treatment will result in better outcomes for~     clients and carers than the outcomes of clients and carers who do not receive the treatment.~     The treatment is a combination of a talking treatment and sharing of stories about mental~     health. The treatment will be delivered to the client with their chosen carer and with the~     local Aboriginal Mental Health Worker or Health Worker. The treatment will be given by the~     research team - a psychiatrist and an indigenous research officer. The trial will compare two~     groups of clients - a control group which is receiving 'treatment as usual', and the group~     which receives the new treatment. Measures of social functioning and symptoms of mental~     illness will be administered at base line and every six months for two years.~   "
256547|NCT00192569|"~     Australian Trial in Acute Hepatitis C (ATAHC)~      A prospective non-randomised dual arm longitudinal cohort of newly acquired hepatitis C~     infection into which participants will be enrolled and then followed at 3 monthly intervals~     over a 3 year period.~      All participants will be offered a 24 week course of pegylated interferon alfa 2a which will~     be commenced within 12 weeks of screening (patients coinfected with HIV will be offered 24~     weeks with pegylated interferon alfa 2a plus ribavirin).~   "
256548|NCT00192556|"~     This study will examine whether food is a cost-effective method for improving treatment~     compliance for TB patients in Timor Leste. Our hypothesis is that the provision of locally~     available, locally acceptable, cheap and highly nutritious food at the clinic will encourage~     patients to come for daily directly observed treatment, and thus improve the chance of TB~     cure and decrease the chance of the development of TB drug resistance. Primary outcome will~     be successful completion of treatment and secondary outcomes will include treatment~     compliance and clinical and biological measures of nutritional improvement.~   "
256549|NCT00192543|"~     Cardiovascular disease is the main cause of death in patients on dialysis for end stage renal~     disease. Omega-3 fatty acids and antioxidants have been shown to be protective in the general~     population. A diet of fish and fruit, which will provide the fatty acids and the antioxidants~     is being tried in dialysis patients to assess the effect on cardiovascular disease in this~     high risk group.~   "
256550|NCT00192517|"~     The primary objective of this study is to compare the effects on disease activity, in the~     absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly~     by SC injection for 12 weeks.~   "
256551|NCT00192504|"~     MEDI-524 administered as a single IV dose at 3, 15, and 30 mg/kg to children hospitalized~     with RSV infection was safe and well tolerated.~   "
256552|NCT00192491|"~     -  To compare immune responses to measles, mumps, rubella, and varicella antigens following~          vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in~          children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ~          (Group 2 vs. Group 1).~        -  To compare immune responses to the three strains of influenza (H1N1, H3N2, and B)~          following a two dose regimen of FluMist in children who receive the initial FluMist dose~          concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist~          alone (Group 2 vs. Group 3).Secondary:~        -  To assess the safety and tolerability of concurrent administration of FluMist with~          MMRIIÒ and VARIVAXÒ.~   "
256553|NCT00192478|"~     MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe~     and well tolerated.~   "
256554|NCT00192465|"~     To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524~     administered initially as a single dose to healthy adults in a dose escalation safety study~     before testing in the targeted pediatric population.~   "
256555|NCT00192452|"~     - The primary objective of this study is to compare disease activity, as measured by PASI~     score, of two MEDI-507 dose levels (0.012 and 0.04 mg/kg) versus placebo administered by~     intravenous infusion every 2 weeks for a total of 8 infusions.~   "
256556|NCT00192439|"~     - Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash~     aspirates in children at high risk for severe LRI disease (hospitalized at <2 years of age).~   "
256557|NCT00192426|"~     Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when~     administered concomitantly with CAIV-T to healthy children.~   "
256558|NCT00192413|"~     To demonstrate that the efficacy over a defined surveillance period against culture-confirmed~     influenza-illness caused by community-acquired subtypes antigenically similar to those~     contained in the vaccine, in adults aged at least 60 years at enrollment, of a single~     intranasally (IN) -administered dose of a liquid formulation of influenza virus~     vaccine,(CAIV-T) is non inferior compared with that of a single dose of commercially~     available influenza vaccine inactivated (TIV) administered intramuscularly (IM) prior to the~     anticipated commencement of the influenza season.~   "
256559|NCT00192400|"~     The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T~     against culture confirmed influenza illness in healthy children aged at least 6 months and~     less than 36 months.~   "
256560|NCT00192387|"~     The primary objective of this study was to determine the proportion of subjects, seronegative~     to all three strains of influenza, as defined by a serum hemagglutination inhibition~     antibodies (HAI) antibody titer of <1:10, who shed each vaccine virus strain following a~     single dose of CAIV-T.~   "
256561|NCT00192374|"~     - Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels~     of a Liquid Formulation of(CAIV-T) in Healthy Children.~   "
257581|NCT00178607|"~     To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.~   "
256565|NCT00192322|"~     To perform a variety of assays on blood, nasal washes, and cells obtained from healthy~     children for the purposes of further investigation of immune responses generated by influenza~     virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle~     Vaccines, Marietta, PA).~      • To assess nasal swab specimens to detect vaccine virus shedding.~   "
256566|NCT00192309|"~     The primary objective of this study was to perform a variety of assays on blood, serum, nasal~     wash and cell samples obtained from healthy adult subjects for the purposes of developing~     assays for application in the further investigation of immune responses generated by~     influenza virus vaccine, trivalent, types A & B, live, cold-adapted (liquid formulation~     CAIV-T; Wyeth, Marietta, PA).~   "
256567|NCT00192296|"~     Phase I study to evaluate the safety and tolerability of escalating single IV doses of~     MEDI-528.~   "
256568|NCT00192283|"~     The purpose of this study is to determine the efficacy of the liquid formulation of CAIVT~     against culture confirmed influenza illness in healthy children aged at least 6 months and~     less than 36 months, attending day care centers in Europe. In addition, the trial provides~     the opportunity to investigate the effect of CAIV-T on acute otitis media, on healthcare~     resource utilization and economic resources.~   "
256569|NCT00192270|"~     The study was designed to determine the number of doses of CAIV-T required to effectively~     immunize children and adolescents in the 6 to 17 year age group.~   "
256570|NCT00192257|"~     - Trial to assess asthma exacerbation through to the end of the study; and to demonstrate~     that the efficacy over one season against culture-confirmed influenza-illness; and finally to~     assess the safety and tolerability of CAIV-T in children with asthma.~   "
256571|NCT00192244|"~     - The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian~     population aged from 6 months to less than 36 months, in tropical and temperate climates,~     against culture-confirmed influenza illness. In addition, the trial provides the opportunity~     to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the~     effect of CAIV-T on acute otitis media.~   "
256572|NCT00192231|"~     The primary objective of this study was to perform a variety of immunological assays on~     blood, serum, nasal wash samples, and cells obtained from healthy adult subjects for the~     purpose of developing assays for application in the further investigation of immune responses~     generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid~     CAIV-T).~   "
256573|NCT00192218|"~     To measure the effectiveness of influenza vaccination in school children by comparing,~     between target(i.e., children are offered FluMist) and control (i.e., children are not~     offered FluMist) school families.~   "
256574|NCT00192205|"~     - Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture~     confirmed influenza illness in children.~   "
256575|NCT00192192|"~     To perform a variety of assays on blood, serum, nasal wash samples and cells obtained from~     healthy adult subjects for the purposes of developing assays for application in the further~     investigation of immune responses generated by influenza virus vaccine, trivalent, types A~     and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).~   "
256576|NCT00192179|"~     A safety study to compare, over a 7 day period, the fever rates following one dose of either~     Influenza Virus Vaccine or placebo administered outside the influenza season to healthy~     children and adolescents aged 6 to less than 18 years.~   "
256577|NCT00192166|"~     - The primary objective of the study was to determine if intranasally administered influenza~     virus vaccine, CAIV-T), when administered concomitantly with a subcutaneously administered~     combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children~     interferes with the immune responses.~   "
256578|NCT00192153|"~     The purpose of this clinical study was to evaluate immune responses measuring antibodies in~     serum and secretions and cellular immune responses generated by CAIV-T vaccine in healthy~     adults aged 18 years and older as a means to develop assays for application in investigating~     potential immunological correlates of protection and/or establishing assays to measure~     vaccine take.~   "
256579|NCT00192140|"~     -  To describe the proportion of individuals 5-49 years of age who shed vaccine strain~          viruses.~        -  To describe the duration of shedding of vaccine viruses in individuals 5-49 years of~          age.~        -  To describe the genotypic and phenotypic stability of shed vaccine viruses.~        -  To describe the immune responses of FluMist in individuals 5-49 years of age.~        -  To describe the safety of FluMist in individuals 5-49 years of age in relation to~          shedding and the immune response~   "
256580|NCT00192127|"~     This study is to assess the safety of a bivalent vaccine of two new 6:2 influenza virus~     reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist)~     containing them.~   "
256581|NCT00192114|"~     Enzastaurin given daily to patients with colorectal cancer who have Stage 4 disease and have~     not received prior chemotherapy for advanced colorectal cancer~   "
256582|NCT00192101|"~     This is an open label, two arms, randomized, unblinded phase 2 study in patients with locally~     advanced or metastatic breast cancer who have been previously treated with anthracycline~     with/without taxane based regimen in the adjuvant/neoadjuvant or 1st line metastatic setting.~     Gemcitabine will be administered via intravenous infusion over approximately 30 minutes at a~     dose of 1250mg/m2 on days 1 and 8 of each 21-day cycle. In arm A:Cisplatin will be given via~     intravenous infusion over approximately 60-120 minutes at a dose of 70 mg/m2 on Day 1 of each~     21-day cycle. The investigator may attempt to give Cisplatin with at least one liter of~     fluids for hydration and on an outpatient basis.~      Patients will remain in the study until disease progression or when a maximum of six cycles~     have been administered. Study therapy may continue until:~        -  There is evidence of progressive disease~        -  The patient experiences unacceptable toxicity.~        -  The investigator decides that the patient should be discontinued.~        -  The patient requests discontinuation~        -  The patient has received 6 cycles of the regimen (if the physician decides to continue~          after 6 cycles-this will be done after consultation with the sponsor)~        -  Discontinuation from study therapy is indicated according to the additional guidelines~          described in the protocol After patients discontinue from study therapy, they proceed to~          the post-study follow up phase of the study.~   "
257459|NCT00180232|"~     The study tries to reveal if aminobisphosphonates influence aside the bone density also the~     vascular status in the typical elderly patient population~   "
256583|NCT00192088|"~     Open label single arm phase II study of Pemetrexed plus Oxaliplatin in patients with advanced~     gastric carcinoma not previously treated with palliative chemotherapy. 43 Patients will be~     enrolled in this local trial. The primary objective of this study is to determine the~     response rate of the treatment.Schedule for this study is as follows: 6 cycles/21 days of~     Pemetrexed 500 mg/m2 followed by Oxaliplatin 120 mg/m2. This study will also include~     pharmacogenomic and pharmacogenetic investigations in order to assess determinants of~     efficacy and toxicity of the treatment with Pemetrexed and Oxaliplatin in the study~     population.~   "
256584|NCT00192075|"~     The purpose of the study is to describe the tumor response rates for the two regimens being~     studied, and to determine how long patients live after receiving the treatment, how long~     patients are without return of their disease after they receive treatment, and how long the~     response they get from the treatment lasts. The amount and type of side effects/toxicities of~     each regimen will also be evaluated. The regimen including Oxaliplatin + 5FU/Folinic Acid is~     a current standard of care.~   "
256585|NCT00192062|"~     This is a Phase II study of gemcitabine- Vinorelbine combination in a 3-weekly schedule as~     first line chemotherapy in patients with metastatic breast cancer. Eighty patients with~     measurable disease will be enrolled in the study. Gemcitabine will be used at 1000 mg/m2,~     vinorelbine at 25mg/m2. Every cycle, vinorelbine will be administered before gemcitabine.~     After the initial dose, modifications of Gemcitabine and vinorelbine doses are allowed based~     on patient toxicity~      Study therapy may continue until:~        -  There is evidence of progressive disease~        -  The patient experiences unacceptable toxicity.~        -  The investigator decides that the patient should be discontinued~        -  The patient requests discontinuation~        -  The patient has received 6 cycles of the regimen(if the physician decides to continue~          after 6 cycles-this will be done after consultation with the sponsor)~        -  Discontinuation from study therapy is indicated according to the protocol It's the~          investigator's responsibility to strictly stick to the protocol procedures. It needs to~          be discussed with Lilly medical designee in advance when any special situation occurs~          which has not been defined in protocol.~      After patients discontinue from study therapy, they proceed to the post-study follow up phase~     of the study. Assessments to take place during this phase are outlined in the protocol.~   "
256586|NCT00192049|"~     Gemcitabine has been shown to be highly effective and well tolerated in the first and second~     line therapy, as a single agent or in combination therapy for treatment of metastatic~     transitional cell carcinoma. On the basis of Gemcitabine clinical activity and good~     tolerability this drug has been recently tested in intravesical therapy. we consider~     Gemcitabine as a good therapy candidate for patient with intermediate risk superficial~     bladder cancer. Based on the phase I/II clinical trials w are going to explore the efficacy~     and tolerability of Gemcitabine in this setting, and compare it to Mitomycin C which is~     widely used in this group of patients.~   "
256587|NCT00192036|"~     The purpose of the study is to evaluate the response rate of patients with non small lung~     cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this~     combination will also be evaluated.~   "
256588|NCT00192023|"~     The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric~     patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD).~     The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and~     ODD symptoms in patients non responders to a previous psychological intervention with parent~     support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid~     conditions associated with ADHD and ODD will be assessed.~   "
256589|NCT00191997|"~     This is a randomized, parallel, open-label study of patients who have responded to treatment~     in the acute phase of their manic or mixed episode, with or without psychotic symptoms, with~     olanzapine in mono or co-therapy, and who are in syndromic and symptomatic remission at the~     time of enrollment into the study.~   "
256590|NCT00191984|"~     A non-randomized phase II study to determine the efficacy and safety of the combination of~     Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.~   "
256591|NCT00191971|"~     To investigate efficacy and safety of 2nd line GEM monotherapy after CDDP regimen for~     patients with transitional cell carcinoma of urothelium~   "
256592|NCT00191945|"~     Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with~     recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1).~     The double blinded period will last 12 weeks and the treatment open phase will last up to 1~     year, and atomoxetine treatment will be administered.~      A gatekeeper strategy will be employed for sequentially testing the secondary objectives.~   "
256593|NCT00191932|"~     A multicentre, randomised, open label study of out-patients with major depression who have~     failed to respond adequately to antidepressant treatment for their current episode of~     depression. The study compares outcomes associated with two methods of switching from current~     antidepressant to duloxetine~   "
256594|NCT00191919|"~     To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the~     Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment~   "
256595|NCT00191906|"~     To test the hypothesis that a 4 week treatment with atomoxetine is more effective than~     placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD),~     patients with only Reading Disorder, and patients with combined type ADHD and Reading~     Disorder.~   "
256596|NCT00191893|"~     The purpose of this study is to assess the effect of 24 months of treatment with once daily~     teriparatide injection (recombinant human PTH [1-34]) 20 micrograms on bone histomorphometry~     and architecture. Patients will include postmenopausal, osteoporotic women who have been~     treated long term (at least 36 months) with alendronate, as well as postmenopausal,~     osteoporotic women who have never been treated for osteoporosis.~   "
256597|NCT00191880|"~     Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with~     Attention- Deficit/Hyperactivity Disorder~   "
256598|NCT00191867|"~     The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese~     Postmenopausal Women with Osteoporosis.~   "
256613|NCT00191659|"~     To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine~     hydrochloride in comparison to standard current therapies have greater improvements in their~     quality of life.~   "
256599|NCT00191854|"~     The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the~     treatments of MBC; however, the optimal dosing schedules for these combinations have not yet~     been determined. The primary objective of this study is to compare the response rates of the~     gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when~     administered on a biweekly schedule in metastatic breast cancer.~   "
256600|NCT00191841|"~     To evaluate the clinical response rate of neoadjuvant chemotherapy with gemcitabine and~     cisplatin in patients with operable NSCLC~   "
256601|NCT00191828|"~     Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia~     and moderate to severe manic episode.~      Olanzapine is among the many antipsychotic agents associated with weight gain . The mechanism~     for antipsychotic drug-related weight gain is not known, although antagonism of serotonin~     receptors, especially the 5HT2C , and histamine receptors has been hypothesized.~      The purpose of this study is to observe the efficacy of a psychoeducational programme in~     managing the increased weight as a side effect of the olanzapine treatment.~      Interventions to prevent weight gain associated with olanzapine should at least include~     periodic monitoring and recommendations for changes in diet and physical activity.~      This is a phase IV, randomised, parallel study of subjects previously treated with olanzapine~     as antipsychotic monotherapy, which have shown an increase of B.M.I. >7% from the beginning~     of antipsychotic treatment (assessed during the routine visits). For the first 12 weeks of~     the trial approximately 60 outpatients, enrolled in one site during a period of one year,~     will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine + psychoeducational~     programme or olanzapine alone. In the following 12 weeks of the study all patients undergo~     the psychoeducational programme. The efficacy of this programme will be assessed monitoring~     the mean difference from baseline to endpoint in total body weight and BMI.~   "
256602|NCT00191815|"~     The purpose of this study is to determine the objective tumor response of the first-line~     therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer~   "
256603|NCT00191802|"~     The purposes of this study are to evaluate the acceptance of the subcutaneous drug~     teriparatide over 6 months of therapy in patients with severe osteoporosis in Canada, and to~     evaluate how often such patients are actually able to use the injection; to obtain additional~     safety data (side effect data) that will supplement the existing database of adverse events~     that have been reported to-date in clinical trials by patients treated with teriparatide; to~     document the prior use of other osteoporosis therapies in this patient population, and~     ongoing use of other osteoporosis therapies during the study; and to describe the baseline~     demographics and disease state of these severely osteoporotic patients.The purposes of the~     study extension are to continue to assess the acceptance of the subcutaneous drug~     teriparatide over up to 18 months of therapy in patients with severe osteoporosis in Canada,~     and to continue to assess how often such patients are actually able to use the injection; to~     obtain additional safety data (side effects) that will supplement the existing database of~     adverse events that have been reported to date in clinical trials by patients treated with~     teriparatide.~   "
256604|NCT00191789|"~     Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant~     chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and~     cisplatin, also a highly active combination in this indication, may result in improvement in~     pathological response and overall survival. Patients with operable breast cancer will be~     treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine~     plus cisplatin.~   "
256605|NCT00191763|"~     Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for~     patients with resectable non-small cell lung cancer. The exploration of new drugs and~     regimens are warranted. Therefore the aim of this study is to evaluate the clinical response~     rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable~     non-small cell lung cancer stage IB, IIA-B, IIIA.~   "
256606|NCT00191750|"~     The purposes of this study are to determine 1) the safety of pemetrexed and any side effects~     that might be associated with it 2) whether pemetrexed can help patients with small cell lung~     cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how~     long and 4) to see if patients feel better while taking pemetrexed~   "
256607|NCT00191737|"~     A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and~     tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by~     patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12~     through 17 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in~     Germany. An 8-week treatment phase is followed by a 16-week extension period.~   "
256608|NCT00191724|"~     An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation~     study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a~     combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.~   "
256609|NCT00191711|"~     The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is~     enough active in patients with a solitary, low risk superficial bladder cancer.After~     diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical~     gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all~     patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the~     initial lesion.~   "
256610|NCT00191698|"~     The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of~     ODD in children with ADHD and ODD.~   "
256611|NCT00191685|"~     The purpose of this study is to determine the optimal treatment strategy for MDD patients~     with melancholic features who do not respond to a standard daily dose. This study will allow~     investigators to mimic standard clinical practice. During the first 2 weeks of treatment,~     clinical evaluation of individual patient tolerability and efficacy will enable the dose of~     duloxetine to be adjusted. Patients allocated to the Flex group may have their daily dose of~     duloxetine adjusted in the attempt to elicit a clinical response.~   "
256612|NCT00191672|"~     The combination of docetaxel and gemcitabine has shown significant activity in patients with~     metastatic breast cancer. Several studies have activity in patients of multiple lines of~     therapy, including patients that have been treated with prior taxane therapy. Overall~     responses have ranged from 30% to 79%. The major side effects of the combination chemotherapy~     have been neutropenia, anemia, asthenia, neuropathy, nausea, mucositis, and neutropenic fever~   "
256614|NCT00191646|"~     This is a phase III randomized study comparing induction treatments of Gemcitabine and~     Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for~     patients that do not have any evidence of disease after completion of six cycles of induction~     therapy. Patients with disease after induction therapy will crossover to receive single agent~     therapy.~   "
256615|NCT00191633|"~     The purpose of this study is to assess whether changes in the symptoms of ADHD show a~     relationship with changes in functioning in children with ADHD treated with atomoxetine over~     a 3-month period.~   "
256616|NCT00191620|"~     The purposes of this study are to determine:~      How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus~     cisplatin in the treatment of non-small cell lung cancer.~      The safety of standard gemcitabine plus cisplatin and any side effects that might be~     associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.~   "
256617|NCT00191607|"~     This trial compares two chemotherapy agents for the treatment of recurrent ovarian, fallopian~     or primary peritoneal cancer in patients that have received and are no longer responding to~     Platinum based treatment. The purpose of this trial is to compare progression free survival~     between gemcitabine and liposomal doxorubicin. Progression free survival (PFS) is defined as~     the period from study entry until disease progression~   "
256618|NCT00191594|"~     A study in patients with depression~   "
256619|NCT00191581|"~     The primary objective of this study is to compare the 2-hour PPBG excursion following a~     standard test meal in insulin-requiring diabetic patients treated twice daily with human~     insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with~     insulin lispro mix 50/50.~   "
256620|NCT00191568|"~     A non-randomized phase II study to determine the efficacy and safety of the combination of~     Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with~     surgically resected pancreatic cancer.~   "
256621|NCT00191555|"~     The objective of this study is to demonstrate that there is a benefit in switching chronic~     schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy,~     neurological safety and patient's outcome.~   "
256622|NCT00191542|"~     Comparison of the effect of Atomoxetine and psychoeducation with placebo and psychoeducation~     after 10 weeks of treatment~   "
256623|NCT00191529|"~     Comparison of 2 different doses of human growth hormone treatment on change in height after 1~     and 2 years of treatment.~   "
256624|NCT00191516|"~     A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and~     tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by~     patients, parents and physicians, and its impact on quality of sleep in children (aged 6~     through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in~     Germany. An 8-week treatment phase is followed by a 16-week extension period.~   "
256625|NCT00191503|"~     There is no standard treatment for the patient population being asked to participate in this~     study. Although one current regimen, used by some investigators, has a high rate of response~     compared to other therapies, it is associated with moderate to severe toxicity. As~     gemcitabine and pemetrexed have a broad range of activity against cancer it is reasonable to~     determine how active and safe they are against patients with this type of cancer.The~     objective of this study is to determine the anti-tumor activity of pemetrexed and gemcitabine~     in patients with this condition.~   "
256626|NCT00191490|"~     Phase II study that will evaluate the activity of gemcitabine as intravesical therapy on the~     marker lesion in superficial bladder carcinoma at intermediate risk. Primary objective is the~     evaluation of the pathological complete response after 8 instillation of gemcitabine. 46~     patients are requested.~   "
256627|NCT00191477|"~     A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the~     efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately~     after transurethral resection of the bladder tumor.~   "
256628|NCT00191464|"~     The primary objective of this study is to show that a prandial insulin regimen, consisting of~     premeal insulin lispro mid mixture (or a combined regimen of insulin lispro mid mixture~     and insulin lispro low mixture) plus metformin will result in significantly better overall~     glycemic control (lower HbA1c) at endpoint than once-daily insulin glargine plus metformin.~     Insulin lispro mid mixture consists of 50% insulin lispro and 50% NPL. Insulin lispro low~     mixture consists of 25% insulin lispro and 75% NPL.~      In a substudy of approximately 60 patients, additional data will be collected on markers~     associated with risk of atherosclerosis or cardiovascular disease in the context of a~     controlled, outpatient, high-fat test meal.~   "
256629|NCT00191451|"~     The purposes of this study are to determine the safety of gemcitabine and paraplatin either~     with or without trastuzumab Any side effects that might be associated with these compounds.~     Whether the two or three drugs listed above when given in combination can help patients with~     metastatic breast cancer. How long the treatment will stop the growth of the cancer.~   "
256630|NCT00191438|"~     This is a phase III randomized study which compares two different regimens of chemotherapy.~     The purpose of the study is to determine which of the two regimens will make the tumor~     smaller or disappear, and for how long. In addition the disease-related symptoms will be~     evaluated. The safety of the drugs will be determined based upon evaluation of the side~     effects~   "
256631|NCT00191425|"~     The primary purpose of the study is to compare 3 different osteoporosis therapies following~     one year of teriparatide.In the first year,all eligible patients received open-label~     teriparatide 20 micrograms/day.After 1 year, patients are randomly assigned to one of 3~     possible follow-up treatment regimens for the second 12 months: continuation of teriparatide,~     switch to raloxifene, or no pharmacological treatment(other than the calcium and vitamin D~     supplements that everyone receives). Patients are stratified into 3 subsets: (a) patients who~     have never received any anti-osteoporosis treatment before; (b) patients who received prior~     antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior~     antiresorptive drugs (such as bisphosphonates or raloxifene) in the past. These latter~     patients are not randomized at month 12 but will continue treatment with teriparatide 20~     micrograms/day throughout the second year.~   "
256632|NCT00191412|"~     This study is to assess the response rate, toxicity, time-to-event efficacy, and potential~     markers of pemetrexed in patients with liver cancer.~   "
256633|NCT00191399|"~     The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine~     combined on all the visits as compared with the baseline visit in patients with bipolar~     disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale~     (MADRS).~   "
256634|NCT00191386|"~     The study is long-term extension study to evaluate long-term safety and efficacy of~     Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder~     (AD/HD).~   "
256635|NCT00191373|"~     This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over~     approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be~     administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion~     administered on subsequent cycles.~   "
256636|NCT00191360|"~     To evaluate long-term safety of growth hormone replacement in adult patients with growth~     hormone deficiency~   "
256637|NCT00191347|"~     This study is designed to determine the efficacy of the biweekly pemetrexed/gemcitabine~     regimen when given to patients with metastatic breast cancer. Each agent has well~     demonstrated antitumor activity in patients with locally advanced or metastatic breast~     cancer. In addition, in the phase I combination trial of the two agents, a durable tumor~     response was seen in one out of three heavily pretreated breast cancer patients (Adjei et al.~     2000). Therefore, it is reasonable to expect that the combination of pemetrexed and~     gemcitabine administered may be associated with considerably more anti-tumor activity than~     either agent alone. If such activity is seen in this study, randomized studies comparing this~     combination with other active agents or combinations of active agents will be considered.~   "
256638|NCT00191334|"~     The primary endpoint of this study is to assess the objective tumor response rate in patients~     with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250~     mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment~   "
256639|NCT00191321|"~     A pilot study on the use of Teriparatide in severe osteoporotic women with hip fracture and~     submitted to hip replacement~      The primary objective of this study is to obtain preliminary data, in a pilot group of~     postmenopausal women with established osteoporosis and a recent hip fracture, who underwent~     hip replacement 3-6 months before screening phase, about the effect of teriparatide on:~        -  bone turnover markers: CTx, PINP and BSAP when given at the dose of 20 mcg/day by~          subcutaneous route for 18 months.~      The secondary objectives of the study are as follows:~        -  Effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as~          assessed by BMD measurement with dual energy x-ray absorptiometry (DXA)~        -  Effects of teriparatide on quality of life and back pain during treatment.~   "
256640|NCT00191308|"~     The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant~     chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC)~     is to look at various genes present in participants' blood and tumor tissue to see if there~     is any link between the levels or changes in the genes and how participants with lung cancer~     respond to pemetrexed and cisplatin treatment.~   "
256641|NCT00191295|"~     Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)~   "
256642|NCT00191282|"~     The primary objective was to demonstrate a difference between two insulin strategies, one~     targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial~     hyperglycemia, on time until the first combined adjudicated cardiovascular (CV) event~     (primary outcome defined as CV death, nonfatal myocardial infarction [MI], nonfatal stroke,~     coronary revascularization, or hospitalized acute coronary syndrome).~   "
256643|NCT00191269|"~     To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with~     anthracycline and taxane regimen for patients with metastatic breast cancer~   "
256644|NCT00191256|"~     To evaluate the rate of complete pathological response after 3 cycles of gemcitabine~     containing chemotherapy.~   "
256645|NCT00191243|"~     Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients~     will be treated with docetaxel or docetaxel-gemcitabine.~      Aim of the study is to assess the optimal dosage and safety in this setting.~   "
256646|NCT00191230|"~     To study the efficacy and tolerability of gemcitabine/platinum chemotherapy in non small cell~     lung cancer~   "
256647|NCT00191204|"~     The purpose of this study is to monitor the long term safety of duloxetine in the treatment~     of stress urinary incontinence.~   "
256648|NCT00191191|"~     To investigate efficacy and safety of pemetrexed as second or third line therapy in patients~     with non-small cell lung cancer (NSCLC).~   "
256649|NCT00191178|"~     This study investigates the influence of two different insulin regimens, twice-daily insulin~     lispro low mix (LM) and once-daily insulin glargine, on perceived physical, mood, and~     cognitive symptoms as well as cognitive-motor task performance in patients with type 2~     diabetes.~   "
256650|NCT00191165|"~     Multi-center, randomized, controlled, open-label, phase III study comparing the effects of~     two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of~     treatment, on height velocity in early pubertal children with growth hormone deficiency~     (GHD). The study will be conducted in Italy. Approximately 26 subjects will participate in~     this study, distributed as 13 in the in-label dosage group (group A) and 13 in the doubled~     dosage group (group B).~   "
256651|NCT00191152|"~     This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/~     capecitabine doublets, with crossover to the alternate agent. The experimental arm will~     receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75~     mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive~     docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1~     through 14 repeated every three weeks. Patients who progress on the experimental arm, will be~     treated with capecitabine as dosed on the comparator arm. Patients who progress on the~     comparator arm will be treated with gemcitabine as dosed on the experimental arm.~   "
256652|NCT00191139|"~     To assess the 2 year survival of patients with Stage III unresectable non-small cell lung~     cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent~     chemotherapy and radiation.~   "
256717|NCT00190294|"~     Compared the interest of one week expectancy vs immediate medical treatment in the taking~     care of the evacuation of the no evolutionary pregnancies before 13 GW.~   "
256653|NCT00191126|"~     Preoperative chemotherapy is considered to play a role in early stage non small cell lung~     cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven~     feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the~     present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with~     Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery~     alone. Postoperative chemotherapy will not be utilized in this Phase III trial.~   "
256654|NCT00191113|"~     A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger~     than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin)~     treatment in promoting linear growth to final height.~   "
256655|NCT00191100|"~     The purpose of this study is to compare the effectiveness of two methods of treating cancer~     of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing~     radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will~     receive cisplatin along with radiation therapy without adjuvant therapy.~   "
256656|NCT00191087|"~     The purpose of this study is to monitor the long term safety of duloxetine in the treatment~     of stress urinary incontinence.~   "
256657|NCT00191074|"~     After approval of amendment (g), patients who were still receiving study drug at the time~     were scheduled for a study visit. In addition, patients who had discontinued early from the~     core, blinded phase of the study were contacted.~      All of these patients were offered the opportunity to enter the unblinded extension phase (if~     they met eligibility criteria) and continue somatropin treatment (regardless of initial~     treatment randomization) until they reached final height.~   "
256658|NCT00191061|"~     The purpose of this study is to compare the tolerability and efficacy of different doses of~     duloxetine in patients with major depressive disorder.~   "
256659|NCT00191048|"~     The purpose of this study is to assess the efficacy and safety of atomoxetine administered~     once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.~   "
256660|NCT00191035|"~     The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine~     administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52~     weeks~   "
256661|NCT00191022|"~     This study is a Phase 2 trial to test the efficacy of LY686017 in the treatment of Social~     Anxiety Disorder.~   "
256662|NCT00191009|"~     This study will compare atomoxetine to placebo when taken with current standard Alzheimer's~     Disease medications. The treatment will take approximately 6 months and it is hypothesized~     atomoxetine will significantly improve cognitive performance as compared to placebo.~   "
256663|NCT00190996|"~     The purposes of this study are to determine whether duloxetine can help subjects with stress~     urinary incontinence and to see whether the effects of duloxetine can be maintained.~   "
256664|NCT00190983|"~     This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV~     over 10 minutes in patients with recurrent cervical cancer.~   "
256665|NCT00190970|"~     To determine the effect of Ruboxistaurin on small fiber function.~   "
256666|NCT00190957|"~     Atomoxetine Treatment of Adults with ADHD and Comorbid Alcohol Abuse~   "
256667|NCT00190944|"~     Effects of Teriparatide on Distal Radius Fracture Healing~   "
256668|NCT00190931|"~     The overall primary objective of this study is to test the hypothesis that, compared with~     placebo,administration of atomoxetine will result in an improved work productivity.~   "
256669|NCT00190918|"~     This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low~     risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.~   "
256670|NCT00190905|"~     The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women~     of different backgrounds with stress urinary incontinence who may also have other various~     medical conditions.~   "
256671|NCT00190892|"~     This trial will assess any efficacious benefit and any safety issues associated with the~     concomitant use of olanzapine and carbamazepine for the treatment of patients with bipolar I~     disorder, manic or mixed episodes~   "
256672|NCT00190879|"~     To investigate the effect of atomoxetine hydrochloride in treating adults who have attention~     deficit hyperactivity disorder with comorbid social anxiety disorder~   "
256673|NCT00190866|"~     To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in~     patients with Fibromyalgia syndrome, with or without major depressive disorder.~   "
256674|NCT00190853|"~     Biomechanical and electrophysiological effects of duloxetine in the treatment of women with~     urinary stress incontinence~   "
256675|NCT00190840|"~     In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small~     cell lung cancer as a single agent as well as in combination with cisplatin. Since the~     introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety.~     Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed~     dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with~     supplementation may increase pemetrexed's efficacy without unduly compromising safety. The~     present Phase 2 study will use pemetrexed dosing that is tailored to individual patient~     tolerance, and is an effort to determine the efficacy and safety of this approach in patients~     with advanced NSCLC who had prior chemotherapy.~   "
256676|NCT00190827|"~     The study evaluates the effectiveness of duloxetine in reducing urinary incontinence~     occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence~     is the inability to control bladder function with leakage of urine.~   "
256677|NCT00190814|"~     The purpose of the study is to evaluate the effectiveness of duloxetine in reducing urinary~     incontinence(leakage of urine)occurrences in women due to physical stress and leakage that~     occurs during a strong need(urge) to urinate.~   "
256718|NCT00190281|"~     To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute~     infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as~     acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day~     28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco,~     Italy).~      Study hypothesis: malaria patients should exhibit a different pattern of enhancement,~     particularly when quantitative measurements of the SU signals is performed with destruction~     reperfusion kinetics.~   "
256678|NCT00190801|"~     Pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous~     study, while cisplatin is widely used in the combination chemotherapy of gastric cancer.~     Pemetrexed has shown synergy with cisplatin in preclinical models and in various human~     cancers. The introduction of vitamin supplementation has made treatment with pemetrexed plus~     cisplatin safe and well tolerated. The present phase 2 study is an effort to determine the~     efficacy and safety of the combination of pemetrexed and cisplatin in Korean patients with~     gastric carcinoma who had no prior palliative chemotherapy for advanced disease. The~     patients, who will give their consent for participating in this study, will be screened for~     their eligibility and on meeting pre-defined study eligibility criteria, they will receive an~     intravenous therapy of the combination of pemetrexed and cisplatin for number of times that~     in the opinion of their treating physician is appropriate for them. A response rate of 30% is~     considered as the minimum activity level of interest for this patient population.~   "
256679|NCT00190788|"~     The purpose of this study is to determine whether continued administration of Drotrecogin~     Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion~     period - results in a more rapid resolution of hypotension in severe septic patients.~   "
256680|NCT00190775|"~     This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment~     trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are~     currently living in a family situation with at least one child. The primary objective of the~     study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of~     ADHD symptoms over 12 and 24 weeks of blinded treatment.~   "
256681|NCT00190762|"~     Based on results from earlier clinical trials, Pemetrexed may have antitumor activity as a~     first-line agent in the treatment of mesothelioma. Given this, it is hypothesized that~     Pemetrexed may be active in second-line mesothelioma in which the standard treatment is best~     supportive care. This study will compare survival of previously treated patients with~     malignant pleural mesothelioma who receive Pemetrexed plus best supportive care to the~     survival of similar patients who receive best supportive care alone.~   "
256682|NCT00190749|"~     This study will assess whether olanzapine and/or risperidone affect the way the human body~     uses sugar in the blood.~   "
256683|NCT00190736|"~     A study to compare the effect of once-daily atomoxetine versus placebo in treating symptoms~     of ADHD in adults for up to 6 months.~   "
256684|NCT00190723|"~     1. The safety of LY317615 and any side effects that might be associated with the drug.~        2. Whether LY317615, can help patients with brain tumors.~   "
256685|NCT00190710|"~     To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin~     versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.~   "
256686|NCT00190697|"~     Patients who were previously enrolled on the LY353381 arm of any LY353381 oncology trial~     could enroll in this roll-over study if they had exhibited clinical benefit from treatment~     and wished to continue on treatment. Patients were monitored for safety.~   "
256687|NCT00190684|"~     To learn about the safety and any side effects of atomoxetine when given to children and~     adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children~     and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for~     about 5 years (long-term).~      Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been~     interrupted or, atomoxetine experienced on a known stable dose.~   "
256688|NCT00190671|"~     This is the phase 2 portion of a phase 1/2 trial, testing the use of pemetrexed and~     cyclophosphamide in combination for the treatment of advanced breast cancer. A single arm~     Phase 1 dose finding (establish maximum tolerated dose) study precedes the randomized phase 2~     portion.~   "
256689|NCT00190658|"~     This clinical trial will compare the mean first year height velocity of somatropin-treated~     prepubertal patients with SHOX deficiency with the height velocity of a control group of~     untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a~     somatropin-treated group of girls with Turner syndrome. After the second year patients in the~     control group have the option to receive treatment as well. All patients will optionally be~     treated until they achieved adult height.~   "
256690|NCT00190645|"~     The patients are being followed in this study to determine the safety of taking the~     medication Duloxetine for a long period of time. The patients participating in this study~     suffer from Stress Urinary Incontinence.~   "
256691|NCT00190632|"~     This is an on-going study to evaluate the long-term safety and maintenance of effect of~     duloxetine in patients suffering with stress urinary incontinence.~   "
256692|NCT00190619|"~     The purpose of this study is to monitor the long term safety and efficacy of duloxetine in~     the treatment of severe pure genuine stress incontinence.~   "
256693|NCT00190606|"~     The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle~     training with that of placebo in patients with moderate to severe stress urinary incontinence~   "
256694|NCT00190593|"~     The purpose of this study is to determine whether raloxifene compared with placebo lowers the~     risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal~     women at risk for major coronary events.~   "
256695|NCT00190580|"~     The purpose of this study is to prove the hypothesis that the progression of renal and~     cardiovascular disease is more efficiently prevented when the angiotensin II receptor blocker~     valsartan is added to conventional antihypertensive therapy.~   "
256696|NCT00190567|"~     Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared~     with placebo in the treatment of women with pure genuine stress incontinence~   "
256697|NCT00190554|"~     To determine whether chemotherapy before surgery makes better outcome than chemotherapy after~     surgery in patients with esophageal squamous cell carcinoma~   "
256698|NCT00190541|"~     The purpose of this study is to evaluate the of international standard operation, mesorectal~     excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node~     dissection for clinical stage II, III lower rectal cancer~   "
256699|NCT00190528|"~     To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II~     cervical cancer~   "
256700|NCT00190515|"~     To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy~     for stage III colorectal cancer.~   "
256701|NCT00190502|"~     The primary objective of the study is:~        -  To compare the effect of ATG treatment together with intensified insulin therapy (Group~          1) on fasting and glucagon-stimulated C-peptide production with that of intensified~          insulin therapy only (Group 2) in type 1 diabetes mellitus of recent onset~      Secondary objectives are:~        -  To compare the insulin doses between the two groups at 6, 12, 18, and 24 months after~          diabetes onset~        -  To compare the course of the specific humoral markers of autoimmunity between the groups~        -  To evaluate the significance of in vitro testing of specific T-cell activation by an~          autoantigen in the long-term follow-up in type 1 diabetes~        -  To assess the safety of ATG treatment in type 1 diabetes~   "
256702|NCT00190489|"~     To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison~     with standard AC for metastatic breast cancer~   "
256703|NCT00190476|"~     To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone~     for elderly patients with advanced non-small-cell lung cancer.~   "
256704|NCT00190463|"~     Empirical antifungal treatment is the gold standard for patients who are neutropenic and have~     persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are~     difficult to early diagnose, and are life-threatening. Historical trials have shown a small~     benefit of survival when this strategy is used. According to the drug usde for this strategy,~     safety and costs may be concerns. However, since this routine practice has been implemented~     in hematology, new non-invasive biological diagnostic methods are available to early diagnose~     fungal infections, such as galactomannan antigenemia for aspergillosis. The goal of our study~     is to show that limiting the administration of antifungals in this setting to patients with~     clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces~     the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of~     patients treated with chemotherapy for hematologic malignancies.~   "
256705|NCT00190450|"~     The aim of this study is to assess the clinical benefit of intrastriatal grafting of human~     cells from the foetal ganglionic eminence in patients with Huntington's disease. The duration~     of the study will be 52 months. A first group of patients will be grafted at M13-14 (early G~     group) and a second group of patients will be grafted at M33-34 (late G group). The principal~     criterion is the comparison of the progression between M12 and M32 of the motor score (TMS)~     of the UHDRS between grafted patients (early G group) and not yet grafted patients (late G~     group). An additional evaluation will be performed to compare the progression in individual~     patients over the 52-month study period. We will thus be able to compare the pre and~     post-graft TMS progression for all patients.~   "
256706|NCT00190437|"~     Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung~     disease (COLD) is a major cause of morbidity and mortality in such patients. Although~     bacterial of mortality in such patients. Although bacterial and or viral infections are~     considered as the major precipitating factor, the antibiotic strategy in this setting is~     unclear. The absence of overt infection remains controversial, and has not been adequately~     studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine~     early systemic antibiotic therapy in patients with COLD admitted to the ICU.~      The primary objective of the essay is to evaluate the effectiveness of the precocious~     antibiotic therapy on the length of the respiratory symptoms with the admitted patients in~     polyvalent medical intensive care of chronic obstructive lung disease ( COLD )~   "
256707|NCT00190424|"~     The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is~     effective in the treatment of glioblastoma~   "
256708|NCT00190411|"~     Ehlers-Danlos syndrome vascular type (EDS-IV) is caused by a genetic defect of collagen type~     III. Patient die (median 40 yrs) of vascular complications. There is no treatment. We showed~     that arteries are thin and overloaded in this patients. We test the protective effect of~     celiprolol on cardiovascular events in a 5 years, randomized, PROBE design~   "
256709|NCT00190398|"~     The purpose of this study is to evaluate whether carotid angioplasty with stent (CAS) is as~     safe and effective as carotid surgery in regards to:~        1. the risk of stroke and death within 30 days of the procedure;~        2. the long-term risk of ipsilateral carotid territory stroke, in patients with recently~          symptomatic, severe carotid stenosis suitable for both CAS and carotid endarterectomy.~   "
256710|NCT00190385|"~     Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or~     large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors~     is currently recommended, but the best periodicity is unknown.This randomized trial is aimed~     to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.~   "
256711|NCT00190372|"~     The aim of the project is to demonstrate that a psycho-educational programme designed to~     support and train carers of Alzheimer's disease (AD) patients induces a significantly higher~     benefit than anticholinesterase drug treatment alone or associated to memantine treatment.~     This training programme focuses on the explanation/description of behavioral, cognitive and~     functional disorders induced by the disease, as well as principles of cognitive and~     psycho-social stimulation of the patients in daily life.~   "
256712|NCT00190359|"~     Heart failure induces modification in several neurohormonal systems. The aim of this study is~     to determine if the growth hormone/IGF1 axis is modified in heart failure patients compared~     to healthy volunteers.~   "
256713|NCT00190346|"~     Comparison of humidification devices during non invasive ventilation, in acute respiratory~     failure.~      The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the~     technique (NIV) when HME are used in comparison with HH.~   "
256714|NCT00190333|"~     This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to~     evaluate the efficacy of escitalopram (30 mg/day) in two parallel groups (randomization~     ratio, escitalopram 2/placebo 1).~   "
256715|NCT00190320|"~     Aim of the study :The major aim is to evaluate the effectiveness of the induction of labor in~     case of fetal macrosomia on the reduction of neonatal traumatism risk. The secondary aims are~     to evaluate maternal morbidity and the risk of Caesarean in case of induction of labor,~     compared to a spontaneous labor.~   "
256716|NCT00190307|"~     The STRATAGEM trial is an investigator-driven French nationwide multicenter, randomized,~     double-blind, placebo-controlled trial comparing perioperative low-dose aspirin therapy~     versus placebo in the perioperative period in patients with documented symptomatic stable~     atherothrombotic disease taking antiplatelet therapy and undergoing non-coronary surgery.~   "
256720|NCT00190255|"~     Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the~     use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for~     the elimination of several NSAIDs. This protein is inactive in 12% of the subjects because of~     genetic mutations. We hypothesized that individuals carrying such mutations should be at~     higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.~   "
256721|NCT00190242|"~     Immunogenicity is reduced in immunocompromised patients. The aim of this prospective~     randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of~     anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3,~     co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will~     be evaluate.~   "
256722|NCT00190229|"~     Henoch-Schonlein purpura is a leucocytoclastic systemic vasculitis involving small vessels~     with the deposition of immune complexes containing IgA. It is characterized by the~     association of skin, joint and gastrointestinal manifestations. Even though the evolution is~     usually simple, some patients, especially adults, may have severe visceral involvement~     including heart, lung, brain and renal disease. The best treatment is currently unknown. This~     study will test the safety and efficacy of steroids associated or not with cyclosphosphamide~     to treat the acute lesions and to prevent the development of chronic lesions.~   "
256723|NCT00190216|"~     The hypothesis of this study was that transcranial magnetic stimulation (TMS) focused on~     hyperfunctional cerebral areas should be more effective in treating depressive symptoms than~     stimulations not taking into account the functional specificity of the patient. The goal was~     to compare the effects of guided TMS, using neuroimaging to guide TMS on dysfunctional~     cortical regions individually detected by neuroimaging, with standard TMS, as used in most~     studies, over the left prefrontal cortex, and with sham TMS, in patients with resistant~     depression.~   "
256724|NCT00190203|"~     The purpose of this study is to determine if patients with malignant middle cerebral artery~     infarction have a better clinical outcome after early decompressive surgery compared to~     standard medical management.~   "
256725|NCT00190190|"~     Rational of the study: for macular holes larger than 400 µm the rate of failure is of more~     than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting~     membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of~     this gesture, it is necessary to make a randomized study.~      Primary objective: To show that the percentage of success (anatomical closing, confirmed by~     OCT) at third postoperative month is higher in the ILM peeling group.~      Design of the study: Randomized multicentric study, in parallel groups, with individual~     benefit for the patient.~      Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than~     400 µm is increased by the peeling of the MLI.~      Awaited results: To show that the success rate of the surgery of idiopathic macular holes~     larger than 400 µm is improved by ILM peeling. This category could then have a success rate~     similar to the small holes. If this difference is not proven, it will remain no justification~     to continue this procedure which represents little risk but which is not either without~     consequence.~   "
256726|NCT00190177|"~     The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of~     endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele~     who express less CX3CR1 shoud be protected against this risk. The main objective of the study~     is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The~     secondary aims are the search of an association with the most severe forms of preeclampsia~     and endothelial injury.~   "
256727|NCT00190164|"~     Rational of the study: There are arguments to think that the closure of macular holes can be~     obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if~     the patient avoids the position laid down on the back. In order to be able to confirm these~     observations, it is necessary to make a randomized study with an adequate number of patients.~      Aim of the study: To show that the percentage of success (anatomical closure confirmed by~     OCT) is not lower in the group without positioning.~      Tested Hypothesis: The absence of strict positioning is at least as effective on the~     success of the surgery of small macular holes as the imposition of a strict positioning.~      Expected results: To show that the success rate of the surgery of the idiopathic macular~     holes of 400 µm or less is not decreased by the replacement of a strict positioning~     (face-down 22h/24) by a simple instruction of avoiding the position laid down on the back,~     thus avoiding the patients this painful part of the treatment and allowing a reduction in the~     duration of hospitalization and consequently a reduction in the cost of the treatment.~   "
256728|NCT00190151|"~     Bacterial resistance to antibiotics has been a growing therapeutic problem since the late~     1980s. Resistant strains of pathogenic bacteria can arise through initial selection of~     resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the~     commensal flora will be assessed in 48 healthy volunteers receiving variable doses of~     ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic~     characteristics of ciprofloxacin.~   "
256729|NCT00190138|"~     Patients with congestive heart failure are often associated with delayed intraventricular~     depolarization which causing dyssynchrony and an inefficient pattern of left ventricular~     contraction. A number of studies have shown that bi-ventricular or left ventricular pacing~     improves indexes of systolic function as well as decreases sympathetic activation in patients~     with severe left ventricular systolic dysfunction, dilated cardiomyopathy and a major~     left-sided intraventricular conduction disorder such as left bundle branch block. One recent~     study also demonstrated that bi-ventricular pacing can shift heart rate variability (HRV)~     toward a more favorable profile. Baroreflex sensitivity (BRS) is a measure of the negative~     feedback properties that interact in modulating the dynamic heart rate and arterial pressure~     fluctuations. Blunted BRS is found to be associated with an increased risk for both cardiac~     deaths and arrhythmic events. However, the effect of bi-ventricular pacing on BRS has never~     been studied. In the present proposal, we plan to measure common hemodynamic parameters, BRS~     and HRV in a group of heart failure patients receiving open heart surgery in different pacing~     conditions (bi-ventricular pacing, single LV pacing, single RV pacing). The major aims are to~     investigate the effect of bi-ventricular pacing on BRS and to clarify the underlying~     mechanisms.~   "
256730|NCT00190125|"~     The purpose of this study is to explore the severity of malnutrition and inflammation in~     Taiwanese hemodialysis patients.~   "
256731|NCT00190112|"~     Atrial fibrillation (Af) is the most common morbid event after open heart surgery. Its~     incidence ranges from 19% to 27%, as reported by the Society of Thoracic Surgeons database.~     Many groups have tried to understand and treat this difficult problem and have formulated~     different hypotheses to explain its origin. An imbalance of the autonomic nervous system~     after surgical intervention has been accepted as a major determinant for this morbidity.~     Ventral cardiac denervation is a fast and low-risk procedure. This intervention has shown~     significantly reduction of the incidence and severity of Af after routine coronary artery~     bypass surgery. This technique could be applied both on-pump or off-pump and used as an~     adjunctive procedure to achieve Af prophylaxis. However, the detailed mechanism remains~     unclear. Theoretically, heart receives its innervation from the autonomic nervous system~     (ANS) via the great vessels and pericardial attachment. The propensity and distribution of~     ANS nerve fibers are different in location. In this study, we would like to evaluate the ANS~     function after ventral cardiac denervation by using heart rate variability (HRV) and~     baroreflex (BRS) sensitivity. 30 patients proposed to have elective off-pump coronary artery~     bypass surgery are enrolled. After induction of anesthesia, the depth of anesthesia is~     controlled by inhalation agents and monitored by bispectral index. After the major cardiac~     operation, ventral cardiac denervation is performed by using electrocautery. The digital~     signals of heart rate and blood pressure are acquired before and after the surgical~     procedures under the same range of bispectral index (50~60). The paired HRV and BRS are~     analyzed. This will provide us more information to justify the procedure.~   "
256732|NCT00190099|"~     The major obstacle of the long- termed success of percutaneous coronary intervention (PCI) is~     the restenosis. Restenosis results from complex pathophysiological response of the vascular~     tissue to the balloon injury. In the pre-stent era, 80% of it was attributed to vascular~     recoil. However, by way of the mechanical support of metallic stent, recoil is no more the~     major reason of restenosis. About 80 % of In-stent restenosis resulted from intimal~     hyperplasia.~      The mechanism of the Intra-stent restenosis included 4 stages. First stage comprised the~     first 3 days after balloon injury, when the inflammatory reaction is most severe throughout~     the course. At that time, anti-inflammatory drug as steroid wuold be helpful to prevent the~     course of restenosis. Until the end of the third week, smooth muscle cells migrate and then~     proliferate in the second and the third stage, and the key effort to prevent restenosis right~     now is inhibition of cell cycle. Intravascular radiotherapy (so called Brachytherapy) and~     stent-based drug elution target upon them. Among them, rapamycin and paclitaxel proved to be~     effective both in animal and human experience. The last stage is re-epithelization, estrogen~     could promote the process and was considered to be effective in this stage.~      Stent-based elution of corticosteroid, despite of its feasibility and safety, was not as~     effective as other anti-proliferation agent ( eg. Rapamycin etc). The major reason might be~     the patient group with coronary artery disease is a heterogenous one.~      We believe if we applied corticosteroid over the patient with elevated inflammatory~     parameters, i.e. acute coronary syndrome (ACS) the effect of anti-restenosis would be~     obvious.~      In this study, by a special-designed, phosphorylcholine-coated stent, dexamethasone could be~     readily absorbed and then gradually released locally even 4 weeks after deployment.~      We expected a reduction of In-stent restenosis in ACS patient by the method with no or few~     systemic adverse effect of steroid; and angiographic follow-up as well as intra-vascular~     ultrasound assessment would be performed according to pur protocol.~   "
256733|NCT00190086|"~     Cardiac syndrome X is characterized by angina, positve stress test, and patent coronary~     angiography, and its probable mechanism is microvascular dysfunction associated with~     endothelial dysfunction. We used brachial artery flow-mediated vasodilation to assess the~     endothelial function of the patients with syndrome X, coronary artery disease, and controls.~     Methods: We enrolled 28 patients with syndrome X, 11 healthy volunteers and 11 coronary~     artery disease patients. All subjects underwent a 2-step brachial artery flow-related~     vasodilation test: ultrasound artery diameter was measured at rest and after occlusion to~     assess endothelium-dependent vasodilation and after sublingual nitroglycerin to determine~     endothelium-independent condition. Serum endothelin-1 assay was performed for all~     participants. Results: The cardiac syndrome X patients had lower brachial artery dilation~     ratio (diameter after test/ diameter before test) than controls (1.10 +/- 0.09 versus 1.27~     +/- 0.11, p=0.013), but the ratio is still higher than CAD patients (1.10 +/- 0.09 versus~     1.02 +/- 0.07, p<0.001). After sublingual nitroglycerin, all 50 subjects had adequate~     vasodilation. Besides, normal controls have higher endothelin-1 level than the others.~      We concluded that syndrome X patients have worse endothelial function than healthy control,~     but patients of CAD had even worse endothelium function than cardiac syndrome X patients.~      Keywords: Cardiac syndrome X, coronary artery disease, endothelium-dependent vasodilation,~     endothelium-independent vasodilation, flow-mediated vasodilation, endothelin-1~   "
256734|NCT00190073|"~     Peripheral neuropathy is a frequent neurological complication of chronic alcoholism. Most~     studies evaluated large-fiber involvement by nerve conduction studies (NCS). Since previous~     studies document the predominant injury of small myelinated and unmyelinated fibers in~     patients with alcoholic neuropathy, it will be imperative to know their prevalence and~     clinical significance. Moreover, the pathogenesis of alcoholic neuropathy, especially the~     roles of ethanol and its metabolites and thiamine, remains elusive. This proposal will be~     designed to understand the extent and clinical significance of cutaneous nerve degeneration~     in the skin of alcoholic patients and to investigate its pathogenesis. We will investigate~     cutaneous innervation by 3 mm punch skin biopsies with immunohistochemistry for protein gene~     product 9.5 and quantifying epidermal nerve density (END) in alcoholic patients. Patients~     will undergo clinical evaluation, quantitative sensory testing (QST), nerve conduction~     studies (NCS), and tests of sympathetic skin response (SSR) and beat-to-beat RR interval~     variability (RRIV). The prevalence of peripheral neuropathy in chronic alcoholic patients~     with emphasis on small-fiber involvement will be first evaluated. The sensitivity of punch~     skin biopsy, QST, SSR and RRIV tests, and NCS will be compared, and the correlations between~     END and psychophysic and electrodiagnostic parameters will be discussed. Subsequently, we~     will elucidate the clinical significance of END reduction in alcoholic patients. Patients~     with evidences of involvement of central nervous system will be excluded, and END will be~     correlated with clinical manifestations and neurological deficits. Finally, the role of~     ethanol and thiamine in alcoholic neuropathy will be further studied. To clarify the role of~     thiamine in alcoholic neuropathy, we will examine whether it has influences on small-fiber~     degeneration. This may provide important information in understanding the pathogenesis and~     designing optimal treatment for alcoholic neuropathy.~   "
256735|NCT00190060|"~     The study aims to determine the effects of testosterone on muscle function, mobility,~     activities of daily living and overall quality of life~   "
256736|NCT00190047|"~     This study will examine if DP-b99 can improve neurological function (for example strength and~     coordination) in the 3 months after an acute stroke~   "
256737|NCT00190034|"~     The purpose of this study is to determine whether N-acetylcysteine is effective in the~     prophylaxis of post-cardiopulmonary bypass acute renal impairment.~   "
256750|NCT00189839|"~     The purpose of this study is to evaluate and to compare the efficacy and safety of a triple~     modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard~     tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It~     shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary~     endpoint.~   "
257204|NCT00183781|"~     This study will evaluate the effectiveness of the Family Intervention: Telephone Tracking~     (FITT) program in improving depression, coping, and family functioning in HIV-infected~     individuals and their caregivers.~   "
256738|NCT00190021|"~     Conventional psychotropic medications may be used to treat behavioral disturbances and~     psychotic symptoms in patients with dementia and they are the drugs of choice for treating~     delusions and hallucinations. However the sensitivity to side effects in these patients often~     restricts the use of these agents (2, 3). Although, atypical antipsychotics have some~     advantages compared with conventional neuroleptics, they also are associated with side~     effects (5, 6).~      Cholinesterase inhibitors (ChEIs) enhance neuronal transmission by increasing the~     availability of acetylcholine in muscarinic and nicotinic receptors. According to findings of~     some researchers ChEIs have psychotropic effects and may play an important role in~     controlling neuropsychiatric and behavioral disturbances in patients with Alzheimer's disease~     (7-10). These agents may also contribute to the management of other disorders with~     cholinergic system abnormalities and neuropsychiatric symptoms such as visual hallucinations~     (11).~      Donepezil is a piperidine-based reversible, noncompetitive ChEI, which is indicated in the~     management of patients with Alzheimer's disease of mild to moderate severity (12-14).~     Preliminary observations suggest the possible value of ChEIs in the amelioration of psychotic~     symptoms in patients with dementia of the Alzheimer's type (DAT), dementia with Lewy bodies~     and patients suffering from Parkinson's disease (11-18).~      The results of our study (18) indicate that the addition of donepezil to perphenazine~     resulted in qualitatively superior clinical gains compared to higher doses of neuroleptic~     therapy without donepezil.~      The finding of the pilot study although impressive, stem from data regarding a rather small~     sample. The present (second) phase of the study will include a larger sample of patients. We~     now intend to examine 80 inpatients, aged 65-90 years old, suffering from DAT.~   "
256739|NCT00190008|"~     The mechanism involved in the development of tardive dyskinesia (TD) is complicated. It now~     seems that several neurotransmitter systems may be affected, including dopaminergic,~     noradrenergic, gamma-amino-butyric acid (GABA) ergic, cholinergic and peptidergic pathways.~      Piracetam (2-oxo-pyrrolidone) is a nootropic drug structurally related to GABA. It has been~     used clinically to treat a wide range of diseases and conditions, mainly in treatment of~     organic brain syndrome, myoclonus, memory impairment, post-concussional syndrome, vertigo,~     alcohol withdrawal, cerebrovascular insufficiency, hypoxia, intoxications of different~     origins or mechanic brain injures. Piracetam is cerebral homeostatic normalizer,~     neuroprotectant, cerebral metabolic enhancer and brain integrative agent. It enhances brain~     energy, especially under deficit condition: hypoxia, chemical toxicity or impaired cerebral~     microcirculation; preserve, protect and enhance synaptic membrane and receptor structure and~     plasticity. It has various effects on glutamate neurotransmission on micromolar levels~     piracetam potentiates potassium-induced release of glutamate from hippocampal nerves. It is~     an oxidant agent and may be useful for treatment TD. Piracetam is among the toxicologically~     safest drugs ever developed even in mega doses.~      Data derived from some clinical reports have suggested that piracetam can improve symptoms~     and is effective agent for treatment of different movement disorders including acute~     neuroleptic induced extrapyramidal symptoms and TD. The doses that used for TD treatment~     varied from 800 mg/day to 24000 mg/day. According to these findings the symptoms of TD~     disappeared in the period of 3-7 days.~      To date there was only one double-blind crossover study regarding use of piracetam for~     treatment TD that was conducted almost 20 years ago. The findings of this study were~     impressive, but to our knowledge nobody reproduced these results.~   "
256740|NCT00189995|"~     Aggressive, persistent aggression and impulsive behavior are frequently observed in~     schizophrenic patients. According to some researchers more than 50% of all psychiatric~     patients and 10% of schizophrenic patients show aggressive symptoms varying from threatening~     behavior and agitation to assault(1). It is a common cause of psychiatric admission and is a~     therapeutic issue. The treatment of these symptoms is a clinical problem for both patients~     and staff. Violent behavior, a major detrimental factor in stigmatization of the mentally~     ill, also poses physical danger for the patients themselves. Current pharmacotherapy of~     pathologic aggression involves the use of multiple agents (typical and atypical~     antipsychotics, benzodiazepines, mood stabilizers, beta-blockers, antiandrogenic hormones,~     and selective serotonin reuptake inhibitors) on empiric basis, with varying degrees of~     response (2-6). Unfortunately, these approaches lead to numerous side effects. Poor or~     noncompliance with pharmacotherapy makes it difficult to choose the appropriate preparation.~     Currently, typical neuroleptics are still the first choice in treating acute aggressive~     symptoms, while risperidone and olanzapine could be alternatives (5-7). Typical depot~     neuroleptics should be considered in cases where medication compliance is a problem. Most~     clinical information on treating of aggression has been collected about atypical~     neuroleptics, particularly regarding clozapine.~      Clozapine is indicated in psychotic state and/or in drug-resistant schizophrenic patients.~     According to the FDA - it is the drug of choice in suicidal and aggressive patients, due-to~     psychotic state. It was found helpful in nearly 30% of resistant schizophrenic patients.~     Concerning the parenteral administration of clozapine - very little data is available today.~      This study aims to investigate efficacy and safety (psychopathology, and side effects) of~     parenteral clozapine in treatment of aggressive behavior in schizophrenic patients in a~     double-blind trial.~   "
256741|NCT00189982|"~     The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the~     treatment of children with hemophilia A. The study is open to pediatric patients in Canada~     who completed Baxter Study 060101.~   "
256742|NCT00189969|"~     The purpose of this study is to assess the take rate (formation of a typical postvaccinal~     lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.~   "
256743|NCT00189956|"~     The objective of the study is to find the optimal dose for the smallpox candidate vaccine~     IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at~     three different dose levels.~   "
256744|NCT00189943|"~     The purpose of this study is to collect information on the safety, tolerability and~     immunogenicity of an investigational smallpox vaccine at different doses and using different~     routes of administration in vaccinia-naive and vaccinated healthy volunteers~   "
256745|NCT00189930|"~     The objective of the study is to compare two doses of MVA-nef vs. MVA-BN to induce~     Nef-specific cellular immune response in HIV-1 infected patients~   "
256746|NCT00189917|"~     The purpose of this study is to gather information on the safety and immunogenicity of an~     investigational smallpox vaccine in populations with atopic disorders.~   "
256747|NCT00189904|"~     The purpose of this study is to gather information on the safety and immunogenicity of an~     investigational smallpox vaccine in HIV infected populations.~   "
256748|NCT00189878|"~     The purpose of this study is to determine whether methotrexate produces significant~     improvement in chronic idiopathic urticaria, compared with placebo~   "
256749|NCT00189852|"~     The primary objective of this project is to investigate whether, in a pilot randomised~     controlled trial, the use of telecare (remote monitoring) technologies reduces the frequency~     of hospital admissions for people with chronic heart failure (CHF) and to inform the design~     of a larger randomised controlled trial of telecare for CHF.~      Secondary objectives are:~        1. To investigate whether there are benefits to users~        2. To understand the impact on carers in terms of carer stress~        3. To investigate whether there are benefits to the NHS and other statutory provisions~        4. To investigate which users receive the greatest benefits~        5. To inform whether remote monitoring of CHF patients should be provided as part of~          hospital discharge for a set period of time or whether it should be provided long term~          and be used in a preventative manner~        6. To investigate whether CHF episodes can be detected and predicted based on lifestyle~          changes~        7. To determine whether lifestyle monitoring equipment can be correlated with the~          information from the CHF monitoring system to determine the potential to detect~          deteriorating health.~   "
256776|NCT00189501|"~     Objectives include description of current practices; assessment over time of K/DOQI goals,~     clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and~     the impact of Sensipar® on these parameters~   "
256751|NCT00189826|"~     To evaluate and to compare efficacy and safety of a dual regimen with oral modified release~     tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 /~     steroids in patients undergoing primary liver transplantation. It shall be demonstrated that~     FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.~   "
256752|NCT00189813|"~     This study will examine the efficacy, safety and tolerability of different oral dose of~     YM060, 5-HT3 receptor antagonist, in patients with d-IBS.~   "
256753|NCT00189800|"~     The purpose of this study is to ascertain the clinical results of solifenacin succinate of~     PIII study conducted in the original country using Korean patients with an overactive~     bladder.~   "
256754|NCT00189787|"~     This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.~   "
256755|NCT00189774|"~     The purpose of this study is to investigate the superiority of nateglinide over placebo for~     inadequately controlled type 2 diabetic patients with pioglitazone treatment.~   "
256756|NCT00189761|"~     A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation~     (MR4) in de novo bone marrow transplant recipients~   "
256757|NCT00189748|"~     To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who~     are eligible for the administration after 100 days post transplant (up to 1 year)~   "
256758|NCT00189735|"~     A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant~     patients~   "
256759|NCT00189722|"~     This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.~   "
256760|NCT00189709|"~     To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in~     treating patients with invasive candidiasis or candidaemia~   "
256761|NCT00189696|"~     This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3~     receptor antagonist, in patients with d-IBS.~   "
256762|NCT00189683|"~     To compare maintenance chemotherapy with Xeloda to control after best response with first~     line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival.~     A total of 300 patients will be included.~   "
256763|NCT00189670|"~     To screen a dose-dense arm to be used in a future large scale phase III trial. Primary~     endpoint is safety; secondary endpoints are disease free survival and overall survival. A~     total of 100 patients were included.~   "
256764|NCT00189657|"~     The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or~     LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative~     radiotherapy is recommended but not mandatory. Main endpoint is disease free survival.~     Secondary endpoint are overall survival, time to local recurrence, time to distant~     metastases, and tolerance. A total of 600 patients will be included in the trial.~   "
256765|NCT00189644|"~     The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in~     patients with resected node positive breast cancer. Main endpoint is disease free survival.~     Secondary endpoints are overall survival, time to local recurrence, time to distant~     metastases, and tolerance. A total of 840 patients have been included in the trial.~   "
256766|NCT00189631|"~     To compare maintenance therapy to observation in metastatic breast cancer patients responding~     (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival.~     Secondary endpoints are overall survival and tolerance. A total of 200 patients will be~     included.~   "
256767|NCT00189618|"~     To evaluate the change in walking capacity after a well organized and structured intensive~     physical training program with supportive pharmacotherapy with Clopidogrel or ASA. It is~     hypothesized that statistically superior results will emerge from a structured training~     supported by Clopidogrel as compared to a structured training supported by ASA.~   "
256768|NCT00189605|"~     The goal of this post-marketing surveillance study is to compare two procedures which are~     used to treat patients who require a disc decompression procedure. These procedures are: 1)~     plasma disc decompression procedure using Coblation technology and 2) fluoroscopy guided~     transforaminal epidural steroid injection (TFESI). The study will evaluate treatment efficacy~     and rate of improvement in symptoms through the first six months following the procedure.~      The principal objectives of this study are to determine whether subjects receiving the plasma~     disc decompression procedure demonstrate:~        1. Improved clinical outcomes over subjects receiving TFESI~        2. More rapid reversal of symptoms than subjects receiving TFESI~   "
256769|NCT00189592|"~     The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for~     relieving pain associated with recurring plantar fasciosis and, secondarily, to determine~     whether there may be additional potential benefits stemming from its use.~   "
256770|NCT00189579|"~     The purpose of this study is to evaluate whether or not the addition of Herceptin may be of~     benefit to a standard regimen of carboplatin-paclitaxel.~   "
256771|NCT00189566|"~     This study will look at the efficacy and safety of weekly administration of paclitaxel~     (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin~     in patients with ovarian cancer in early relapse.~   "
256772|NCT00189553|"~     This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in~     combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin~     in patients with epithelial ovarian cancer in late relapse (> 6 months).~   "
256773|NCT00189540|"~     The objective of this study is to test the hypothesis that AMG0001 treatment is safe and~     induces angiogenesis as detected by improved wound healing, reduction in amputation, improved~     pain at rest and hemodynamic measurement and to assess the effectiveness of the~     administrative method.~   "
256774|NCT00189527|"~     Noninvasive ventilation is a therapeutic option in some patients with chronic respiratory~     failure. Patients usually ventilate during nightime with a domiciliary ventilator either in~     assist control or in pressure support mode.~      The aim of this study is to compare the clinical efficacy and the tolerance of assist control~     and pressure support modes during domiciliary noninvasive ventilation in patients with~     chronic respiratory failure.~   "
256775|NCT00189514|"~     This is a long term extension to study 137OB-201 which is designed to examine the effect of~     pramlintide on body weight and its safety and tolerability in obese subjects.~   "
257650|NCT00177697|"~     The purpose of this study to examine the effect of having a weight loss mentor on long-term~     weight loss in overweight adults.~   "
256780|NCT00189449|"~     Seasonal/perennial allergic rhinitis (SAR/PAR) is a common childhood illness. One of the~     leading therapies for the treatment of SAR/PAR is intranasally inhaled corticosteroids (ICS).~     One of the major long-term safety concerns is whether ICS interferes with normal growth in~     allergic rhinitis children. Recent evidence suggests that nasal ICS may cause decreased~     growth. However, the effect of nasal ICS on long-term growth and the attainment of final~     adult height is unknown. Another potential systemic adverse effect of ICS use is suppression~     of the hypothalamic-pituitary-adrenal axis function. The primary hypothesis of this study is~     that triamcinolone acetonide aqueous nasal spray (TAA) will have no effect on measured adult~     height in relation to target adult height in children with allergic rhinitis.~   "
256781|NCT00189436|"~     Subjects aged 1-8 years who have been discharged from the emergency department/outpatient~     care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will~     be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of~     nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates~     during the 21-day follow-up period.~   "
256782|NCT00189423|"~     The purpose of this study is to determine whether performing active compression decompression~     cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) compared to~     conventional standard cardiopulmonary resuscitation (S-CPR) will impact the neurologic~     recovery and survival to hospital discharge following out-of-hospital cardiac arrest.~   "
256783|NCT00189410|"~     Pegylated Liposomal Doxorubicin as well as Carboplatin have been showed efficacy in~     monotherapy as in combination therapy of gynaecologic tumours. As there is no common standard~     in the therapy of recurrent ovarian carcinoma, tumours of the uterus nor for non-epithelial~     ovarian tumours at time of designing of this study, this trial shall evaluate the new and~     well tolerated combination therapy consisting of Pegylated Liposomal Doxorubicin and~     Carboplatin.~   "
256784|NCT00189397|"~     The dermatitis caused by the substances which come in contact with the skin is known as~     contact dermatitis. When such a reaction is caused by the agents suspended in the air, it is~     called air-borne contact dermatitis (ABCD). Parthenium hysterophorus at present is the~     commonest cause of ABCD in India though in some cases other plants have also been found to~     cause ABCD. Parthenium dermatitis is one of the major health problems in dermatology in our~     country. Though it has very little mortality, the disease normally continues to persist with~     variable remissions and relapses causing great distress and morbidity. Corticosteroids,~     topical and systemic have been the mainstay of the treatment so far. Therefore, the patients~     with ABCD who have to take corticosteroids for long periods of time tend to develop severe~     and sometimes irreversible side effects of the therapy. Azathioprine is an immunosuppressive~     drug which acts by inhibiting the T lymphocytes. In our previous studies we have been able to~     induce remissions in these patients with azathioprine used as daily as well as monthly bolus~     dose, without having to use systemic corticosteroids. The side effect with azathioprine in~     these studies were almost absent.~      We have therefore planned to study the therapeutic efficacy of azathioprine weekly pulse~     doses versus daily azathioprine in achieving remissions in patients having Parthenium~     dermatitis and to monitor the side effects of both the regimens.~   "
256785|NCT00189384|"~     Approximately one-third of neonatal deaths in developing countries are due to infections~     acquired through the birth canal and/or exposure to an unclean environment soon after birth.~     Current World Health Organization recommendations for the management of infants younger than~     2 months of age who have serious bacterial infections involve hospitalization and parenteral~     therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin~     combined with an aminoglycoside.However, in many settings throughout the developing world,~     this is not currently possible, nor is this standard of care likely to be feasible in the~     near future. Several studies have reported that for a variety of sociocultural reasons many~     families are unable or unwilling to access hospital-based care and their sick young infants~     do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies,~     or none at all. In our community field sites, approximately 70% of families refuse hospital~     referral for a sick newborn, despite provision of transport.~      Thus, there is an urgent need to define the role of community/first-level facility-based care~     versus hospitalization for the management of young infants with serious bacterial infections,~     and the potential for community-based parenteral antibiotics as an alternative strategy in~     resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated~     significant reductions in neonatal mortality from infections in an underdeveloped rural~     district in Maharashtra, India by a field-based case management approach which used oral~     cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with~     sepsis.~      This study is an equivalence randomized controlled trial (RCT) comparing once daily IM~     ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once~     daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days~     in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or~     sepsis with or without local infections such as skin or umbilical infections) whose families~     refused referral to a hospital. After supplementary informed consent, patients meeting~     specific inclusion and exclusion criteria are randomly allocated to one of the three regimens~     being tested. The study hypothesis is that all 3 regimens will perform equally well in the~     treatment of sepsis in a first-level facility setting.~   "
256786|NCT00189371|"~     Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive~     surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance~     of entering complete clinical remission but about 70% will eventually relapse. Relapse more~     than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive~     disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment~     option. Therapy induced anemia is a common problem resulting in decrease of quality of life.~     The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of~     therapy induced anemia, rate of transfusions and on quality of life.~   "
256787|NCT00189358|"~     Although initially responsive to cytoreductive surgery and platinum- and/or taxane-based~     chemotherapy, a majority of patients with epithelial ovarian cancer, cancer of the fallopian~     tube or the peritoneum will eventually relapse. Recurrence within 6 months after completing~     platinum-containing chemotherapy indicates a platinum-refractory cancer disease. New~     therapeutic strategies are required in platinum-refractory disease. Inhibition of growth~     signals induced by the epidermal growth factor receptor pathway, or by the estrogen receptor~     pathway provides promising targets in epithelial ovarian cancer, cancer of the fallopian tube~     or the peritoneum. The trial is to evaluate the safety and tolerability of the combination of~     the epidermal growth facto tyrosine kinase inhibitor ZD1839 and the clinically established~     antiestrogen tamoxifen.~   "
256838|NCT00188695|"~     The purpose of this study is to test whether or not a new contrast agent called Combidex, a~     contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the~     ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. It might also~     help doctors tell whether or not cancer has spread to these lymph nodes. It might allow~     radiotherapy to be delivered more accurately.~   "
256788|NCT00189345|"~     Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive~     surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance~     of entering complete clinical remission but about 70% will eventually relapse. Many patients~     respond to additional cytotoxic treatment with partial or complete responses, yet~     approximately 100% of these patients will ultimately progress. Novel consolidation strategies~     following treatment for recurrent disease are needed and an immunologic approach is an~     attractive option.EpCAM is expressed in a large number of epithelial ovarian cancer,~     fallopian tube or peritoneal cancer tissues. Thus targeting these cancers with an anti-EpCAM~     antibody is a promising innovative therapeutic approach.~   "
256789|NCT00189332|"~     Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week~     for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.~   "
256790|NCT00189319|"~     The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation~     with controlled release flecainide on patient's quality of life.~   "
256791|NCT00189306|"~     An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied~     topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of~     follow-up.~   "
256792|NCT00189293|"~     The purpose of this study is to compare the recurrence rate following total clearance of~     external genital warts (EGWs) when clearance has been obtained by imiquimod (3 applications~     per week for 4 weeks) followed by ablative therapy (laser or electrocautery therapy) with~     that from just ablative therapy treatment alone.~   "
256793|NCT00189280|"~     BCC is the most common form of skin cancer. Current treatment is often surgery but this can~     be limited by the number of lesions, their location the age of the patient or the potential~     cosmetic outcome. The purpose of this study is to evaluate the effectiveness of imiquimod, on~     a non surgical treatment, in subjects with multiple of large sBCCs.~   "
256794|NCT00189267|"~     The purpose of the study is to compare effectiveness and safety of multiple applications of~     imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.~   "
256795|NCT00189254|"~     The purpose of the study is to obtain recurrence rates and long-term safety data for patients~     who had been treating actinic keratoses on the face and scalp with 5 % Imiquimod Cream in a~     previous study.~   "
256796|NCT00189241|"~     The purpose of this study is to evaluate the long-term sustained clearance rate of~     superficial basal cell carcinoma during a 5 year period following treatment with imiquimod~   "
256797|NCT00189228|"~     We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.~   "
256798|NCT00189215|"~     Coronary artery bypass surgery is associated with postoperative cognitive decline, which has~     largely been attributed to the use of the heart lung machine. We hypothesized that long-term~     cognitive outcome may improve by avoiding the heart lung machine. The objective of the~     present study is to compare the effect of coronary bypass surgery with and without heart lung~     machine on cognitive and clinical outcome, five years after surgery.~   "
256799|NCT00189202|"~     African Americans receiving a kidney transplant are considered at high risk for early~     rejection of their transplanted kidney and require more immunosuppression to maintain their~     kidney transplant function. This increase in immunosuppression puts this group at risk for~     drug-related toxicities and complications such as post-transplant diabetes.~      This study will evaluate:~        1. Whether a sirolimus based steroid avoidance regimen in African Americans may decrease~          the risks of drug-related toxicities,~        2. Decreased rates of metabolic complications such as post-transplant diabetes,~        3. The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.~   "
256800|NCT00189189|"~     Oppositional defiant and conduct disorders are the most frequent bases for referral of~     children and adolescents. These disorders are difficult to treat among school-aged children~     and adolescents. When they become adults they are likely to manifest depressive disorders,~     substance abuse or dependence, and criminal behavior. These disorders are also two of the~     costly childhood disorders. The aim of the study is to assess the preventive effect of parent~     management training in preschool children at risk for oppositional defiant and conduct~     disorders because of high aggression scores on a parent questionnaire. It is hypothesized~     that given the relatively restricted costs of the intervention and the substantial costs of~     burden associated with these children, the intervention will be cost saving.~   "
256801|NCT00189176|"~     This study will evaluate the safety of the administration of a copper chelating agent,~     tetrathiomolybdate, for patients with idiopathic pulmonary fibrosis that have failed previous~     treatment. The primary endpoint for this study is safety with secondary endpoints including~     change in pulmonary function, exercise capacity, and quality of life.~   "
256802|NCT00189163|"~     The presence of insulin resistance (IR) appears to be a key factor in the development of~     steatosis and disease progression in patience with Hepatitis C virus (HCV) genotype-1~     infections similar to levels in Non-alcoholic fatty liver disease (NAFLD). The objective of~     this study is to determine whether Pioglatizone, when given along with Interferon and~     Ribavirin, reduces insulin resistance and lowers HCV viral levels and improved response in~     patients who have HCV genotype-1 infection when compared to a placebo.~   "
256803|NCT00189150|"~     The primary objective of this study is to determine whether a clinically significant PK drug~     interaction ( a 30% difference in the AUC of MPA) exists between mycophenolate mofetil (under~     steady state conditions) and VGCV in renal and cardiac transplant recipients.~      This study will provide clinically relevant information to the transplant community. It will~     more clearly delineate whether a clinically significant PK drug interaction exists between~     mycophenolate mofetil (under steady-state conditions)and VGCV. Given the established~     dose/efficacy relationship of both MMF and VGCV, this study will provide improved dosing~     guidelines and potentially avoid adverse outcomes due to empiric dosage adjustments.~   "
256804|NCT00189137|"~     The purpose of this study is to explore how a sarcoma is affected by and the side effects of~     a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard~     combination of chemotherapy drugs, ifosfamide and doxorubicin.~   "
256839|NCT00188682|"~     The purpose of this study is to learn more about the application of transillumination~     measurements in the determination of breast cancer risk. The goal is to demonstrate a~     correlation between non-invasive optical transillumination spectroscopy and parenchymal~     density pattern.~   "
256805|NCT00189124|"~     The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in~     patients with systemic lupus by measuring:~        1. changes in brachial artery flow-mediated dilatation (FMD) and~        2. changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized,~          double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to~          the alternate treatment arm after a six-week washout period.~      HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE~     modifies cardiovascular risk by improving vascular endothelial function and other biomarkers~     associated with cardiovascular heart disease.~   "
256806|NCT00189111|"~     The purpose of this study is to find out if subjecting cardiac high risk patients to non~     invasive cardiac imaging, followed by treatment will improve survival and quality of life~   "
256807|NCT00189098|"~     Chronic suppurative otitis media is one of the most common chronic infections in children~     worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries, it is~     treated primarily with antibiotics; in other countries such as the Netherlands a surgical~     approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes~     or a tympanomastoidectomy is preferred. There is however, no agreement on the management of~     this disease.~      The purpose of this study is to determine the effectiveness of treatment with~     sulfamethoxazole-trimethoprim for 6-12 weeks in children suffering from chronic otitis media~     and otorrhea.~   "
256808|NCT00189085|"~     In the present study the investigators are researching the effects of the cholesterol~     absorption inhibitor ezetimibe on postprandial lipemia and postprandial endothelial function~     in patients with the metabolic syndrome. The lipid-lowering effect of high-dose statin~     monotherapy on fasting lipids is equal to the combination therapy of low-dose statin and~     ezetimibe.~   "
256809|NCT00189072|"~     The aim of this study was to explore the effects of pain on the one hand and the effects of~     treatment of pain with gabapentin (900, 1200, 1800 or 2400 mg) on the other hand on actual~     driving performance and several laboratory tests in patients with neuropathic pain. It was~     hypothesized that gabapentin might influence performance after acute but not after subchronic~     administration.~   "
256810|NCT00189059|"~     The acute and subchronic effects of amitriptyline were compared to placebo in a double-blind~     crossover randomized study on driving ability and driving-related skills in chronic~     neuropathic pain patients.It was hypothesized that nocturnally administered 25 mg~     amitriptyline might affect driving performance negatively after acute, but not after~     subchronic treatment.~   "
256811|NCT00189046|"~     It has been suggested that cognitive functioning is impaired in chronic pain patients. Since~     most of these pain patients engage in daily activities including driving, it was hypothezised~     that they may have an increased risk of becoming involved in traffic accidents.~   "
256812|NCT00189033|"~     The purpose of this study is to assess the role of dietary fibre in Irritable Bowel Syndrome~     (IBS) treatment, in particular the role of increasing the content of soluble or insoluble~     fibres in the daily diet. The primary objective is to compare soluble (psyllium) and~     insoluble (bran) to placebo, administered over 12 weeks in patients with ‘probable’ or~     ‘definite’ Irritable Bowel Syndrome. The primary efficacy parameter is the responder rate~     based on weekly assessment of adequate relief of IBS symptoms. Secondary efficacy parameters~     include changes in IBS related symptoms (abdominal pain, bowel habits) and quality of life.~   "
256813|NCT00189020|"~     Two( 2) or three (3) instead of four vaccinations before the age of 6 months with~     pneumococcal conjugate vaccine are presumed to protect children against invasive pneumococcal~     disease like meningitis, at least on the short term till 18-24 months of age. The current~     hypothesis in this study is 2 or 3 vaccinations will protect against IPD but will not alter~     pneumococcal nasopharyngeal carriage in infants, and consequently not change pneumococcal~     transmission and induce no herd-immunity. Furthermore, antibody development and memory may~     benefit from carriage of vaccine type S. pneumoniae~   "
256814|NCT00189007|"~     A former study (submitted) in 32 severely asphyxiated infants participating in a randomized~     double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after~     birth) was administered to reduce free radical formation and consequently~     reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and~     no clinically relevant improvement in morbidity in infants treated with allopurinol. It was~     hypothesized that postnatal allopurinol treatment started too late to reduce~     reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus~     with (imminent) hypoxia already via the mother during labor will be more effective to reduce~     free radical-induced post-asphyxial brain damage.~   "
256815|NCT00188994|"~     The purpose of this investigation is to develop a means to improve the recovery of cardiac~     metabolism and ventricular function following coronary artery bypass surgery (CABG) in~     patients with poor preoperative ventricular function (e.g. ejection fraction <40%).~   "
256816|NCT00188981|"~     The Dutch Prediction of Psychosis Study (DUPS) is a prospective study of predictors of the~     transition to psychosis in help-seeking adolescents at high risk for developing a first~     psychotic episode. The aim of the project is supplemented by a systematic account of the~     pathways to care, the disabilities and needs and the therapeutic interventions that are~     currently used in this population.~      Multi-level assessment includes behavioral and cognitive variables as well as structural~     brain imaging and neurophysiological data. Subjects will be followed up at regular intervals~     during (at least) two years to monitor the development of their (psychotic) symptoms. This~     will allow us to analyze the predictive validity of the variables.~   "
256817|NCT00188968|"~     Very premature infants uniformly do not have mature functioning lungs to breathe well nor~     mature regulation mechanisms to breathe regularly. Assistance with a mechanical respirator is~     common. However, prolonged use of a respirator can itself cause long-term complications.~     Furthermore, commonly used drugs to improve the regularity of breathing may have long-term~     consequence only recently recognized. This study will compare two different types of~     assistance using a nasally applied breathing assist device. The aim is to see which type of~     assistance is best at avoiding the need for both prolonged respirator use and drugs to~     regulate breathing.~   "
256879|NCT00188162|"~     The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of~     patients post Lung Biopsy~   "
257819|NCT00175448|"~     A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home~     Exercise Program Following Discharge Home from Total Hip Arthroplasty~   "
256818|NCT00188955|"~     The purpose of this study is to determine whether treatment with sirolimus, in combination~     with low-dose tacrolimus and prednisone, is effective for the treatment of chronic allograft~     nephropathy (progressive scarring) in children who have previously received a kidney~     transplant. This treatment is compared to the standard therapy which uses low-dose~     tacrolimus, mycophenolate mofetil and prednisons.~      This study is a pilot study that will determine whether treatment with sirolimus reduces or~     improves the rate of scarring seen on kidney biopsy of the transplanted kidney over time,~     compared to children who continue to be treated with mycophenolate mofetil.~   "
256819|NCT00188942|"~     This study employs functional magnetic resonance imaging to compare brain activation patterns~     during a depressive episode in patients diagnosed with bipolar disorder, major depressive~     disorder, and a group of healthy control subjects. Depressed patients will be treated with a~     combination of fluoxetine and olanzapine and undergo MRI scans before, during, and after~     pharmacotherapy.~   "
256820|NCT00188929|"~     In this study the treatment process will be closely monitored using a novel imaging~     technology, a PET/CT scanner. PET stands for Positron Emission Tomography and in this case it~     will be combined with a conventional x-ray Computerized Tomography (CT) scan. This is not a~     study of any particular form of treatment. The treatment you receive will be the most~     appropriate standard treatment whether you are in the study or not.~      The goal of radiation therapy is to deliver a given amount of radiation dose to the area~     where there is a lymphoma tumour. We are doing this study to see which part of the tumour~     reacts to the radiation treatment, and which part does not react, by monitoring the progress~     of your treatment with a combined PET/CT scan. In particular, changes of the size and shape~     of the tumour that occur during the treatment can be detected and will be visible on the~     images. These images will be thoroughly analysed. The ability of the PET/CT scanner to detect~     these changes during a course of radiation treatment will be the subject of this study. We~     will also be able to see if this information will eventually relate to or predict whether~     lymphoma tumours will be completely eradicated by the treatment.~   "
256821|NCT00188916|"~     This is a clinical trial comparing surgical conditions during one-lung ventilation with three~     different bronchial blockers or with double-lumen endobronchial tubes.~   "
256822|NCT00188903|"~     Left ventricular (LV) diastolic dysfunction is a common manifestation of heart disease that~     is responsible for significant morbidity and mortality.It is present when the ventricular~     filling is impaired as a result of delayed relaxation or decreased compliance. During~     Coronary artery bypass grafting (CABG) surgery, LV diastolic dysfunction is a frequent~     occurrence. Failure of the left ventricle to dilate normally causes an increase in LV filling~     pressure. Atrial fibrillation (AF) is a common complication after cardiac surgery affecting~     20-30% of patients undergoing coronary revascularization procedures. AF is associated with~     significant morbidity and mortality and has been identified as a causative factor of~     increased length of both hospital and intensive care unit (ICU) stay after CABG surgery,~     resulting in increased resource utilization and medical care costs.The primary aim of this~     study is to determine if patients with preoperative diastolic dysfunction are exposed to~     higher risk of AF after coronary revascularization surgery.~   "
256823|NCT00188890|"~     Occupational exposure to asbestos is known increase the risk of developing cancer of the~     lungs (bronchogenic carcinoma) or of the pleura (mesothelioma). Symptoms are subtle and~     non-specific, diagnosis is often late and the prognosis consequently is dismal. Currently~     there is no accepted non-invasive tool for the early diagnosis of mesothelioma or lung cancer~     in asbestos-exposed subjects. In the last decade, low-dose computed tomography (LDCT) has~     been successfully developed and validated for the early diagnosis of lung cancer in high-risk~     smokers. Malignant mesothelioma might, in an early stage, resemble a benign pleural plaque,~     which is a common finding after asbestos exposure. We target to develop low-dose CT as a tool~     to serially image the pleural plaques, quantify their individual and overall volume, compute~     the growth rate with time, and, as such, identify the presence of mesothelioma early, before~     symptoms occur.~   "
256824|NCT00188877|"~     Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in~     the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of~     these normal tissues. Standard radiation treatment techniques using three or four radiation~     beams cannot avoid delivering some dose of radiation to these normal tissues that do not need~     to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of~     computer-controlled radiation beams aimed at your cancer to try to lower the amount of~     radiation that normal tissues receive, while still delivering the desired amount of radiation~     to your cancer and to areas that your doctor thinks may have cancer cells.~      The doctors at Princess Margaret Hospital are conducting this study in order to test whether~     the use of IMRT techniques can improve the chance of controlling your cancer in the head and~     neck region.~   "
256825|NCT00188864|"~     Brain metastases occur when cancer cells from the initial tumour site (for example, lung or~     breast) spread to the brain. This develops in approximately 10% - 30% of adults with cancer.~     They can produce different complaints related to their effect on brain functioning, decrease~     in a person's ability to carry on with their usual activities, a reduction in the quality of~     life and shortened life expectancy.~      The standard treatment particularly for people with more than one brain metastasis consists~     of palliative radiation therapy to the brain and steroids. Steroids (such as Decadron or~     Dexamethasone) are medication used to reduce swelling around the tumour, and thus symptoms~     improve. Steroids could be very helpful but have a number of potential side effects,~     particularly if used for longer periods of time. There is no standard dose of Decadron used~     in treating brain metastases patients. The most commonly dose used is 4 mg four times/day.~      This study will assess if lower doses of Decadron - 8 mg every morning for symptomatic~     patients and 4 mg every morning for asymptomatic patients - are effective in maintaining~     symptom control in patients with brain metastases, without neurological deterioration that~     necessitates the patient to go back or to a higher dose at any time. This information will~     help also in understanding how to decrease the side effects associated with higher doses of~     steroids in people with your condition.~   "
256826|NCT00188851|"~     The purpose of this study is to assess the virologic impact of switching~     treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with~     or without a 12 week STI prior to the switch.~      Hypothesis: A STI prior to starting a salvage regimen will result in an improved virologic~     response.~   "
256827|NCT00188838|"~     To examine the impact of cognitive-behavioural therapy on both the episodic and functional~     outcome of bipolar disorder, in combination with pharmacotherapy.~      Primary Hypothesis is twofold:~        1. Cognitive Behavioural Therapy will reduce the total symptom burden, as measured both by~          percentage of time spent ill (both syndromic and subsyndromal) and number of episodes,~          as compared to psychoeducation~        2. Cognitive behavioural therapy will reduce social and occupational disability to a~          greater extent than psychoeducation.~   "
256828|NCT00188825|"~     The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction~     therapy combined with standard triple immunosuppression therapy, in the prevention of acute~     rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.~   "
256829|NCT00188812|"~     one year extension study following a previous double-blind study to evaluate safety of the~     drug~   "
256830|NCT00188799|"~     Conformal dose escalated radiotherapy was adopted as the standard treatment technique at PMH~     for intermediate risk patients with localised disease in 1997. This technique provides a much~     smaller margin of error for treatment set-up and delivery than with conventional techniques.~     One way to ensure the accuracy of treatment delivery is to image the prostate position daily,~     prior to therapy, to allow for appropriate set-up corrections. To do so, imaging markers are~     implanted into the prostate under guided ultrasound (a standard procedure at PMH). However,~     there are disadvantages in using imaging markers which include added time to the treatment~     planning process, and an invasive procedure with a potential for discomfort, bleeding and~     infection. This study will investigate and compare X-ray volume imaging to the gold standard~     imaging markers.~   "
256831|NCT00188786|"~     Conformal dose escalated radiation therapy (CRT) is standard treatment for patients with low~     and intermediate risk prostate cancer. CRT requires accurate daily localization of the~     prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam~     computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone~     Beam CT also provides important information on daily position of organs within the pelvis.~     This study aims to assess the feasibility of cone beam CT for daily localization of the~     prostate as well as document changes in size and location of pelvic organs during an entire~     course of CRT.~   "
256832|NCT00188773|"~     A prolonged elevation of plasma free fatty acids (FFA) impairs glucose stimulated insulin~     secretion. The concept of fatty acid impairment of glucose stimulated insulin secretion~     (lipotoxicity) has now been well accepted. Increased free fatty acid flux from adipose tissue~     to non-adipose tissue, resulting from abnormalities of fat metabolism, participates in and~     amplifies many of the metabolic derangements that are characteristic of insulin resistance~     syndrome and type 2 diabetes.~      Lipotoxicity is also likely to play an important role in the progression from normal glucose~     tolerance to fasting hyperglycemia and conversion to frank type 2 diabetes in insulin~     resistant individuals. This area of research is now focused on determining the mechanisms~     whereby FFAs impair b-cell function. There is some evidence to suggest that lipotoxicity~     could be mediated through induction of reactive oxygen species (ROS). N-acetylcysteine (NAC)~     is a known potent antioxidant and has been used experimentally in a number of medical~     conditions in humans for its protective antioxidant effects. The investigators now plan to~     administer NAC orally to humans for 48 hours to examine the effects of antioxidant therapy in~     ameliorating the deleterious effects of FFAs on pancreatic beta cell function. NAC is~     currently approved for the treatment of acetaminophen overdose and is also used as a~     mucolytic agent. The investigators are now using NAC as an antioxidant to determine whether~     it protects the pancreatic beta cell against the toxic effects of FFAs, as outlined in the~     detailed study protocol. This is a proof-of-principle study and is not designed to develop~     n-acetylcysteine for therapeutic use.~   "
256833|NCT00188760|"~     The purpose of this study is to test the ability of a technique called Transillumination~     Breast Spectroscopy (TIBS) to monitor an individual's breast density changes over time.~   "
256834|NCT00188747|"~     Open-heart surgery frequently results in abnormal clotting, which in turn results in~     excessive blood loss and the need for transfusion of multiple blood products to patients and~     leads to adverse outcomes. Prompt identification of any clotting abnormalities after cardiac~     surgery reduces blood loss and blood product transfusion and may improve outcomes. Currently,~     however, this monitoring is dependent on standard laboratory-based tests of clotting that~     have a long turnaround time (30-45 min) and do not measure some important aspect of clotting.~     There are now other monitoring options that are carried out at patients’ bedside, providing~     results more quickly than standard laboratory tests (within 2-5 minutes for some), and~     measure more aspects of clotting, providing more information on possible causes of any~     abnormalities. In this study, we will compare the cost-effectiveness of two of these newer~     monitoring techniques with standard laboratory-based tests by assigning 150 patients who will~     be undergoing open-heart surgery to one of the three monitoring techniques (50 patients will~     be assigned by chance to each group). In each group, an explicit algorithm based on the~     monitoring technique of that group will be used to guide all transfusion decisions.~     Between-group differences in number of units of blood products transfused (primary outcome),~     amount of blood loss, rate of adverse events, and cost of monitoring will be measured. The~     objective of the study is to determine which of the three methods is most cost-effective in~     terms of these outcomes.~   "
256835|NCT00188734|"~     Early detection of lung cancer may improve treatment outcomes. Risk factors have been~     identified, suggesting a population which might benefit from regular screening. Lung cancer~     screening using low-dose computed tomography (LDCT) has experienced a recent renaissance with~     reported sensitivity for detection of lung cancer of 2.7% in high-risk populations. The~     purpose of this study is to evaluate the utility of LCDT for the early diagnosis of lung~     cancer in Ontario.~   "
256836|NCT00188721|"~     This study aims to evaluate if a light based technique, called Transillumination Breast~     Spectroscopy (TIBS), can be used to construct a non-invasive breast cancer risk predictor~     which provides a better odds ratio than mammographic parenchymal density.~   "
256837|NCT00188708|"~     Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have~     low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers~     and make them more resistant to treatment. One previous study has suggested that hormone~     therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to~     test that finding.~   "
256840|NCT00188669|"~     An estimated 20 - 45 % of women treated with breast conserving treatment experience chronic~     pain in the treated breast. The aetiology of this is poorly understood. Some of these women~     have signs of chronic radiation mastitis. There is no accepted treatment for this condition.~     The combination of pentoxifylline and vitamin E has been shown to be effective in reversing~     radiation fibrosis in this region. Many of these patients have had a benefit in pain response~     in a time period of a few benefits. This study is a phase II study of these drugs for a 6~     month trial period to assess the effect on chronic breast pain in breast cancer patients who~     are 3 months to 3 years post radiation treatment.~   "
256841|NCT00188656|"~     This study is conducting a comparison of chest x-ray (CXR) and minimum dose thoracic CT~     (MnDCT) in the detection of lung nodules (metastases) in patients with head and neck~     carcinoma.~   "
256842|NCT00188643|"~     The primary objective of this study is to assess the efficacy of venlafaxine XR and~     lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive~     episodes of bipolar I or Bipolar II disorder. Efficacy of therapy will be evaluated using~     improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions~     on the Hamilton Depression Rating Scale (HDRS-29) total score >50% from baseline. We also~     would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to~     mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well~     as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and~     lamotrigine.~   "
256843|NCT00188630|"~     Cardiac surgery improves the survival and quality of life of people with heart disease.~     Nonetheless, several complications continue to adversely affect outcomes following cardiac~     surgery. Kidney failure is a particularly important complication that is associated with~     increased death and duration of hospitalization. The most severe form of postoperative kidney~     failure, the need for dialysis, is uncommon at present. It is however likely to increase in~     the future. Patients undergoing cardiac surgery are getting older with more heart failure,~     diabetes, high blood pressure, and pre-existing kidney disease. Given that these are risk~     factors for postoperative kidney injury, dialysis rates will likely increase. Although~     multiple therapies have been tested, none have prevented postoperative kidney failure.~     N-acetylcysteine (NAC) is a drug that is commonly used to treat Tylenol overdoses. Over the~     past 2 years, it has also been used to prevent kidney damage after exposure to IV dye. There~     is good evidence that NAC will reduce kidney damage after IV dye exposure. There are strong~     reasons to believe that NAC may also prevent postoperative kidney failure. NAC is safe. Its~     major side-effects are allergic reactions, but serious reactions are rare. Since dialysis is~     uncommon, large studies are needed to determine if NAC prevents postoperative dialysis. In~     this situation, a pilot study is needed to determine if such a large trial is feasible. This~     proposal describes a pilot study. We will determine NAC's effects on creatinine clearance, a~     measure of how well the kidney works. Reduced creatinine clearance is closely related to~     dialysis and death after cardiac surgery. This biological marker allows us to determine NAC's~     effects on kidney function with a reduced sample size. If NAC improves creatinine clearance,~     it would suggest that NAC prevents postoperative dialysis, and would justify a larger study.~     A pilot study will help us estimate how many patients will be willing to participate in~     similar studies, vital for planning a future large study. Finally, our results will estimate~     how well NAC will reduce dialysis rates. This is needed for calculating the sample size for~     future studies.The study design is a randomized, double-blinded, placebo-controlled clinical~     trial among patients undergoing bypass surgery or heart valve surgery at the Toronto General~     Hospital (Toronto, ON). We will recruit 176 people who are at increased risk for developing~     kidney failure after surgery. Participants will receive either NAC or sugar solution during~     their operation. If participants have returned home within a month of surgery, they will be~     contacted at home on the 30th day after surgery to determine if they had any kidney-related~     problems since returning home. All participants will return to the Toronto General Hospital~     (TGH) during the 8th week after surgery for creatinine blood test and weight.~   "
256844|NCT00188617|"~     ELIGIBILITY~        -  Non-small cell lung cancer Clinical Stage 1A (T1N0M0 a tumor that is 3 cm or less in~          greatest dimension, surrounded by lung or visceral pleura, and without bronchoscopic~          evidence of invasion more proximal than the lobar bronchus (i.e., not in the main~          bronchus)* or 1B (T2N0M0 a tumor with any of the following features of size or extent:~          More than 3 cm in greatest dimension. Involves the main bronchus, 2 cm or more distal to~          the carina. Invades the visceral pleura. Associated with atelectasis or obstructive~          pneumonitis that extends to the hilar region but does not involve the entire lung).~        -  Must be deemed appropriate surgical candidate~        -  ECOG performance status £ 2~        -  Age ³ 18 years~        -  No prior chemotherapy, radiotherapy or EGFR inhibitors~      PRE-TREATMENT INVESTIGATIONS~        -  History, physical examination, hematology, biochemistry, toxicity/baseline symptoms:~          within 7 days of registration~        -  Radiology: CT chest within 7 days of registration~        -  Tumor biopsy prior to treatment~      TREATMENT~        -  Gefitinib 250 mg will be administered orally daily x 28 days~      EVALUATIONS ON TREATMENT~        -  Physical examination (vital signs, weight, ECOG performance status) weekly x 4~        -  Hematology (CBC, differential): Day 1,15, 29~        -  Biochemistry (creatinine, electrolytes, bilirubin, alkaline phosphatase, AST/ALT,~          protein): Day 1,15, 29~        -  Radiology: CT at baseline and after day 28~        -  Toxicity evaluation: continuous~      DURATION OF TREATMENT~        -  Treatment is to be discontinued in cases of serious or unacceptable toxicity, or by~          patient or physician request~        -  Otherwise duration of therapy will be a maximum of 28 days~   "
256845|NCT00188604|"~     The primary objective of this study to assess the effectiveness of selenium compared to~     placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are~     to assess the impact of selenium on patient's quality of life and to assess the incidence of~     adverse effects of selenium therapy.~   "
256846|NCT00188591|"~     The proposed pilot study attempts to investigate the feasibility of Optical Spectroscopy (OS)~     as a method to quantify breast tissue composition and density in adolescent females. Our~     goals include: to assess whether adolescent girls can be instructed to assist with the OS~     measurement procedure and to determine the OS technique's ability to show breast tissue~     composition and density in adolescent breast tissue.~   "
256847|NCT00188578|"~     Standard treatment for gynecological cancer is radiation therapy in two phases; whole pelvic~     radiation and then an internal radiation boost, also called a brachytherapy boost, to treat~     any remaining tumour.~      The purpose of this study is to test an alternative radiation boost treatment called~     conformal intensity modulated radiation therapy or IMRT. Currently, we do not have complete~     information on the overall effectiveness of IMRT compared to brachytherapy or conformal~     radiotherapy. We know that IMRT allows the radiation beams to be more accurately focused on~     the tumor, thereby sparing more normal tissue from radiation damage and lowering risks of~     side effects. We are investigating the extent to which IMRT can be used to protect normal~     tissues in patients with cervix, uterine or vaginal cancer from the radiation beams and how~     much the side effects of radiation are reduced.~   "
256948|NCT00187239|"~     The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM)~     implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction~     Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two~     methods of programming with respect to intrinsic activity.~   "
256848|NCT00188565|"~     Colorectal carcinoma is the third most common cause of death from cancer. Approximately, 30%~     of colorectal carcinomas involve the rectum. Optimizing local control in the pelvis while~     reducing treatment toxicity remains one of the principal goals of therapy for patients with~     locally advanced rectal carcinoma. Treatment strategies that achieve this goal will have a~     significant impact on our society.C linical trials have shown that this type of cancer is~     less likely to come back if chemotherapy and radiotherapy are added to surgery. A combination~     of all three types of therapy is now standard.~      Celecoxib (Celebrex®) is a drug that lessens the action of an enzyme called cyclooxygenase-2~     (COX-2) also known as a COX-2 inhibitor. It is an anti-inflammatory capsule (drug that~     reduces irritation) that is commonly used to treat arthritis. It is not a chemotherapy drug.~     Laboratory experiments have shown that such COX-2 inhibitors may increase the anti-cancer~     effect of radiotherapy, without increasing radiation side effects. This has not yet been~     confirmed in humans.The main purpose of this study is to confirm that celecoxib does not~     increase the side effects when given with radiotherapy and chemotherapy for rectal cancer. We~     shall also be looking at how effective the combination of radiotherapy, chemotherapy and~     celecoxib is in shrinking rectal cancer.~   "
256849|NCT00188552|"~     Patients with radiation induced injuries experience significant pain and negative effects on~     quality of life. Currently, no standard therapy for these patients exists, with some patients~     treated symptomatically, and others treated with hyperbaric oxygen or pentoxifylline/Vitamin~     E. This study will examine prospectively the safety and efficacy of using a regimen of~     pentoxifylline and vitamin E in patients with late radiation induced injuries.~   "
256850|NCT00188539|"~     The aim of this study is to measure the oxygen content and interstitial fluid pressure in~     cervix cancer patients. Tumour oxygen content and internal pressure of tumours may be an~     important factor that influences the effectiveness of radiotherapy and other treatments.~   "
256851|NCT00188526|"~     This study is a comparison of core needle biopsy with fine needle aspiration biopsy in the~     evaluation of lung nodules.~   "
256852|NCT00188513|"~     There are several different treatment schedules being used across the world for treatment of~     prostate cancer with radiation therapy. In order to determine the best radiation treatment~     for this disease, a study is being performed by the doctors at the Princess Margaret~     Hospital. This study will try to measure the effectiveness and side effects of an increased~     dose of radiation to the prostate that is also given over a shorter number of weeks than is~     usually done. In order to try to reduce the possible side effects of the radiation therapy~     the treatment will be given using special techniques to shield as much of your normal body~     tissues as possible. This method of treatment is called conformal intensity modulated~     radiation therapy, or IMRT.~   "
256853|NCT00188500|"~     The purpose of this study is to determine whether patients with uncontrolled epilepsy can~     follow a low carbohydrate diet long-term and if so, how will that diet affect their seizures~   "
256854|NCT00188487|"~     Asthma is a disease of small airways. Affected areas have reduced lung ventilation causing~     reflex vasoconstriction. MR perfusion imaging of the lungs is a sensitive method of imaging~     zonal lung perfusion.~   "
256855|NCT00188474|"~     There is much data in the literature regarding optimal treatment approaches for malignant~     pleural effusions as assessed by patient outcomes. However, data on quality of life and~     satisfaction with treatment from the patient's perspective is not available.~   "
256856|NCT00188461|"~     Hypothesis: Does a 50% reduction in radiation in dose significantly affect the diagnostic~     quality of chest CT~   "
256857|NCT00188448|"~     Repeat MRI of the Superficial temporal Artery in 5 volunteers~   "
256858|NCT00188435|"~     A comparison of chest x-ray (CXR) and Minimum dose CT (MnDCT) in the acutely ill patient. The~     hypothesis is that MnDCT is more sensitive than CXR in the detection of acute findings in the~     acutely ill patient.~   "
256859|NCT00188422|"~     The primary outcome of this study is the detection of lung metastases comparing Low dose CT~     (LDCT) and Minimum dose CT (MnDCT) with CXR.~      Hypothesis~        1. LDCT and MnDCT have similar sensitivity for the detection of lung nodules (metastases).~        2. MnDCT of the thorax detects a larger number of nodules (metastases) than CXR.~   "
256860|NCT00188409|"~     A CT scan is performed after a lung biopsy in order to detect a Pneumothorax. We postulate~     that CT is more useful than chest radiography~   "
256861|NCT00188396|"~     Objectives: This prospective investigation will compare premenopausal, perimenopausal and~     postmenopausal women's response to antidepressant medication. The effects of the menstrual~     cycle on the symptoms of depression and antidepressant response will also be examined.~      Hypotheses: Premenopausal women will show a significantly better response to a selective~     serotonin reuptake inhibitor (SSRI) than peri- or postmenopausal women. Premenopausal women~     during lower estrogen phases of the menstrual cycle will complain of increased depressive~     symptoms despite treatment. Perimenopausal and postmenopausal women with irregular periods~     and generally low estrogen levels will show less symptom variability over time.~      Method~      Subjects: Eighty-four women (28 premenopausal, 28 perimenopausal, 28 postmenopausal) meeting~     Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for~     major depressive disorder will be enrolled in the study.~      Procedure: All the subjects will be followed prospectively for 12 weeks and through 2~     menstrual cycles while receiving treatment with a standard SSRI antidepressant agent. All~     eligible women will have a structured clinical interview and will complete questionnaires~     assessing their depressive symptoms. Blood samples will be collected to evaluate for~     reproductive hormone levels during the late follicular, midluteal and late luteal phases of~     the menstrual cycle for two consecutive cycles. Serum SSRI levels will also be collected at~     these times. As the women in the perimenopausal and postmenopausal groups either have~     irregular menstrual cycles or no longer cycle, they will have blood samples drawn at baseline~     and on 6 other occasions.~      Research Implications: As the majority of psychiatric medication is prescribed to women,~     understanding the interplay between the menstrual cycle and antidepressant medication will~     ultimately translate into more diverse and improved patient care. The proposed study is one~     within a developing research program, which will in part be further guided by this study.~   "
256862|NCT00188383|"~     The primary aim is to determine whether perioperative NMDA-receptor antagonism has~     differential effects on postoperative pain, hyperalgesia and morbidity in younger and older~     patients. In order to achieve this aim, the researchers propose to conduct the first~     randomized, double-blind placebo-controlled study designed to investigate age differences in~     the effects of perioperative oral administration of an NMDA-receptor antagonist (amantadine)~     in men undergoing radical prostatectomy. In addition, age differences in psychosocial factors~     and the pharmacological properties of amantadine and morphine will be measured to control~     for, and clarify, their contribution to the differences found.~      The specific objectives of the study are to:~        1. investigate the effects of perioperative NMDA receptor blockade on postoperative~          hyperalgesia, pain and analgesic consumption in young and elderly men~        2. assess age differences in the intensity and course of secondary hyperalgesia after~          surgery~   "
256863|NCT00188370|"~     A group of researchers at the Ontario Cancer Institute/Princess Margaret Hospital have~     discovered that a very specific form of cell death 'apoptosis' can be detected using~     high-frequency ultrasound imaging. This type of cell death is recognized to occur in tumours~     in response to various different chemotherapeutic drugs and in response to radiation therapy.~     This group of researchers has confirmed that high-frequency ultrasound can detect apoptosis~     in response to tumour treatments experimentally using cell culture and experimental animal~     systems. The ultrasound approach is now being evaluated clinically in a 3-year clinical trial~     enrolling a target of 200 patients including Hodgkin's disease and non-Hodgkin's disease~     lymphoma patients, melanoma patients and patients with basal cell carcinoma. Our hope is to~     be able to use this type of imaging system in the future to clinically monitor the effects of~     therapy on tumours and rapidly detect tumours which are not responding so that changes in~     therapy can be made much quicker than presently possible.~   "
256864|NCT00188357|"~     Several studies have shown that persons with systemic lupus erythematosus (SLE) have poor~     general health and a higher risk of heart attack and bone loss (osteoporosis) compared to the~     general population. Some of the risks associated with heart attacks and bone loss are~     modifiable (can be changed). For example, high blood pressure, high cholesterol, smoking,~     lack of exercise are risk factors associated with heart attacks that can be changed. Whereas,~     age and a family history of heart attacks are risk factors that can not be changed.~     Similarly, a diet low in calcium, smoking and lack of exercise are modifiable risk factors~     associated with osteoporosis; while, family history and age are not modifiable. The Health~     Improvement and Prevention Program (HIPP) in Systemic Lupus Erythematosus was developed to~     increase the general health in persons who have lupus and to help reduce the risk of heart~     attacks and bone loss. This intervention program gives comprehensive~      information about lupus and provides tools on how to live better with lupus. The program~     includes visits with a nurse case manager who will work in close collaboration with the lupus~     team. She will work on an individual basis with each participant to develop a mutually agreed~     upon personalized care plan aimed at improving general health, coping skills and heart and~     bone health.~      HIPP STUDY (Health Improvement And Prevention Program)~      Dr Paul Fortin Principal Investigator~      Primary and Secondary objectives:~        -  To improve health status, decrease cardiovascular risk and improve endothelial function~          in persons with SLE compared to usual care.~        -  To improve bone health behaviors and prevent decrease in bone mineral density.~        -  To improve adherence to treatments.~        -  To help persons with Lupus move toward wellness by increasing knowledge.~        -  To show that HIPP is cost effective and could become standard care.~      Duration: 2 years~      Enrollment 240 patients~      Study Design:~        -  Randomized prospective study of HIPP compared to usual care, patients will be crossed~          over at Mth 12. Data collected for 24 mths.~        -  Demographic, health status, cost, SLE knowledge, coping, cardiovascular and osteoporosis~          information will be collected.~        -  All patients will undergo clinical evaluation to measure disease activity, BMD (every 2~          years) and Flow mediated Doppler (every year)~        -  HIPP now patients will attend 4 knowledge sessions, covering SLE, coping with chronic~          disease, cardiovascular disease in Lupus, bone health in Lupus.~        -  HIPP now patients will be followed by nurse coordinator and receive an individualized~          risk assessment, telephone follow-up, smoking cessation counseling. For those found at~          risk stress reduction (Mindfulness Based Stress Reduction) and or bone health program~          will be provided. Hipp now patients will attend Cardiac Rehabilitation Program at TWH.~          All HIPP now pts will attend the Cardiac Rehabilitation program at the TWH.~      Inclusion Criteria:~      SLE according to ACR, >18 yr, Female, must read and write french or english~      Exclusion Criteria:~      MI, TIA, CVA, Other arterial occlusion, PVD, Osteoporosis as defined by BMD, Pregnant now,~     active cancer~      For further information contact Study Coordinator Anne Cymet Tel # 13-2895 Pager 416-664-~   "
256865|NCT00188344|"~     The purpose of this study is to compare pneumatic dilatation and laparoscopic Heller myotomy~     in patients with achalasia in order to learn which of these two treatments should be~     recommended to patients in the future.~   "
256866|NCT00188331|"~     This is a prospective, longitudinal cohort study to evaluate fatigue and cognitive function~     in patients with colorectal cancer (CRC) treated with chemotherapy, and in patients with the~     same malignancy, that do not receive chemotherapy. A self-report questionnaire for fatigue~     (the FACT-F), and validated tests of cognitive function, will be applied at predetermined~     times before, during and after chemotherapy, to determine the incidence, severity and~     duration of these symptoms. Comparisons will be made in changes in cognition for individuals,~     as well as between the chemotherapy and the control group. Mechanisms that might lead to~     fatigue and/or cognitive decline will be investigated.~   "
256867|NCT00188318|"~     This study is examining the effects of increasing the dose of radiation given to treat head~     and neck cancer. Radiation doses to the primary cancer are higher than usually given; lymph~     glands of the neck will also be treated at a lower dose. Surgery on the lymph glands my be~     necessary in the future. Radiation treatments given in small fractions twice a day allows a~     higher dose to be delivered than if the treatment was given once a day. This study will~     enroll patients at three sequential increasing dose levels. Approximately 40 patients will be~     enrolled at each dose level.~   "
256868|NCT00188305|"~     Having at least one first-degree relative (FDR) with colon cancer increases an individual's~     risk of developing the disease. Many relatives of cancer patients are ineligible for genetic~     testing and, therefore, do not receive information from a healthcare provider about the~     disease. Providing relatives of cancer patients with information about their risk of~     developing colon cancer, screening information, and other colon-related health information,~     may increase knowledge and screening compliance as has been shown in relatives of breast~     cancer patients. The primary aim of this study is to test the efficacy of two modes~     (in-person vs. telephone) of providing a risk counseling and health promotion intervention~     for relatives of cancer patients on measures of knowledge of colon cancer risk and~     health-related factors, comprehension of risk, understanding of screening recommendations and~     intent to adopt an appropriate screening regimen. Participants will be randomized into one of~     three study arms (in-person, telephone, control). An assessment pre- and post- intervention~     will be conducted. In addition, longer-term follow-ups will be carried out two months and one~     year following the intervention to examine the sustainability of the intervention effect.~   "
256869|NCT00188292|"~     Cancer of the anus occurs at very high rates in young men with HIV and is caused by a virus~     called human papillomavirus (HPV). Anal cancer has increased during the HIV epidemic despite~     effective therapies for HIV. Unfortunately, anal cancer presents at a late stage because~     there is no screening program to find it at an early stage.~      Rates of other cancers such as cervical cancer have been reduced through the use of Pap~     smears. The researchers' plan is to do the same type of screening for anal cancer as has been~     done for cervical cancer. If abnormalities are found then treatment can be started. The~     researchers hope that this approach will help to prevent anal cancer.~      Testing for HPV will also be done to see if this helps to detect early cancer and to see how~     accurate different tests, pathologists and clinical examiners are at detecting and agreeing~     on any abnormalities.~      The main outcome is the presence of any pre-cancerous or early cancer changes as determined~     by high resolution anoscopy (HRA). HRA involves looking through a microscope into the anus~     and this allows very tiny changes to be identified. Pieces of tissue can then be taken to~     make a definite diagnosis.~   "
256870|NCT00188279|"~     This study is designed to help decide whether a CAT scan performed at a very low dose of~     radiation (Minimum dose CT scan) is better than a Chest X-Ray in detecting recurrence of lung~     cancer in the chest (after surgery).~   "
256871|NCT00188266|"~     In 1991, the South West Oncology Group (SWOG) conducted a randomized study of adjuvant~     chemotherapy (5-fluorouracil and folinic acid) with concurrent radiation (4500 cGy/25~     fractions) versus surgery alone for patients with completely resected gastric carcinoma.~      This landmark study showed the benefit of adjuvant treatment for gastric cancer and radically~     changed the treatment of this disease. However, the resulting standard treatment has severe~     acute toxicity, and despite this advance, 50% of patients still die of gastric cancer. The~     investigators hope to develop a modified protocol using active chemotherapy agents, but with~     reduced acute toxicity. Such an approach could ultimately be studied against the current SWOG~     approach to determine whether or not the addition of cisplatinum improves efficacy.~      Patients who decide to participate in the study will receive a chemotherapy drug called~     5-Fluorouracil (5FU)through an intravenous catheter continuously over 12 weeks. Patients will~     not be admitted to hospital to receive the chemotherapy but will need to wear a waist pack to~     carry a small pump that will deliver the medication. They will however need to make regular~     visits to have their medication bags changed. Patients will also receive Cisplatin~     intravenously every 2 weeks for 4 doses. In addition, patients will also receive radiation to~     their stomach, lymph nodes, and the area where they had their surgery. This study also~     comprise of a questionnaire for us to see how patient's cancer and treatment is affecting~     their quality of life. Patients will have regular follow-up by their physicians.~   "
257205|NCT00183768|"~     This study will evaluate the effectiveness of combining cognitive behavioral therapy (CBT)~     and antidepressants in reducing HIV risk behavior and drug relapse rates in depressed~     intravenous drug users.~   "
256872|NCT00188253|"~     The standard treatment for nasopharyngeal cancer involves either radiation alone or radiation~     plus chemotherapy. Before the start of treatment,patients require an imaging scan to assess~     the extent of disease. The most commonly used test is a magnetic resonance imaging (MRI)~     scan.~      The goal of the study is to examine the value of a new imaging technology that has recently~     become available at the University Health Network Hospitals called Positron Emission~     Tomography scanning (PET). PET scanning involves the injecting a small amount of a drug~     through a vein in the arm called 18-fluorodeoxyglucose (18FDG). This drug is special in that~     it is radioactive and will be detected by the PET machine. Cancer cells are believed to be~     more active than normal cells and have a high rate of metabolism. Therefore, cancer cells are~     thought to take up glucose (a kind of sugar) faster than normal cells in the body. Because~     18FDG is a modified type of glucose, it is also taken up by cancer cells. Special imaging~     cameras will be able to visualize the areas of uptake and reveal sites of cancer involvement.~     The main goal of this study is to evaluate whteher the scan is able to detect the presence of~     nasopharyngeal carcinoma (NPC) both before and after treatment and to specifically compare it~     to findings on magnetic resonance imaging scans (MRI).~      In addition to doing the PET scans, we are asking patients to have blood samples drawn~     throughout their treatment and follow-up, for a research test called Epstein Barr virus (EBV)~     DNA levels. The Epstein Barr virus is thought to have a role in the development of~     nasopharyngeal cancer, and many patients with nasopharyngeal carcinoma are found to have high~     levels of EBV DNA levels in their blood. The second goal of this study is to evaluate whether~     changes in EBV DNA levels are associated with the treatment and the disease course in~     nasopharyngeal cancer, and whether they help to predict any changes in the cancer. This part~     of the study involves the sampling of a small amount of venous blood at a time prior to the~     beginning of therapy and at regular intervals following treatment.~   "
256873|NCT00188240|"~     The literature suggests that there may be an association between hepatitis C and type 2~     diabetes mellitus independent of the presence of cirrhosis, the likely mechanism for which is~     insulin resistance. The prevalence of insulin resistance in patients with hepatitis C is~     unknown. Furthermore, there are no studies that indicate an increased prevalence of insulin~     resistance in patients with hepatitis C compared to other etiologies of liver disease. The~     role that hepatitis C may have in the development of insulin resistance is unclear. The~     effect of antiviral therapy for hepatitis C virus on insulin resistance has not been~     addressed. The long-term consequence of insulin resistance is type 2 diabetes mellitus. There~     is significant morbidity and mortality from type 2 diabetes mellitus in the general~     population, and similar complications would be expected in patients with hepatitis C and~     insulin resistance particularly if they develop type 2 diabetes mellitus.~      Our hypothesis: The prevalence of insulin resistance is increased in patients with chronic~     hepatitis C compared to chronic hepatitis B. Secondarily, insulin resistance when present in~     patients with chronic hepatitis C improves with successful antiviral therapy.~      This study has two phases. The first phase of our study will be to estimate the prevalence of~     insulin resistance in individuals with chronic hepatitis C without cirrhosis compared to~     patients with chronic hepatitis B without cirrhosis. The second phase of the study will be~     restricted to those patients with hepatitis C found to be insulin resistant from phase 1, in~     the absence of known risk factors for insulin resistance (cirrhosis, diabetes). The effect on~     insulin resistance of anti-viral therapy to eradicate hepatitis C will be assessed.~   "
256874|NCT00188227|"~     The purpose of this study is to investigate and compare the effects of three different~     methods for reducing pain and anxiety in adult patients undergoing puncture of the bone~     marrow. The investigated methods are: cognitive behavioural technique, administration of a~     sedative drug(Midazolam) and administration of an analgetic drug (Piritramid)prior to the~     procedure. Additionally, there are two comparison groups in which the patients receive either~     placebo treatment or no treatment at all.~   "
256875|NCT00188214|"~     Cancer of the lung is treated with surgery, radiation or chemotherapy, depending on the stage~     or extent of the disease. Some patients are treated with chemotherapy and/or radiation~     therapy before surgery to improve the results of surgery. After these treatments, we do not~     know whether the residual tumour tissue is still alive or dead, which is why some physicians~     feel that surgery is required to remove it.~      This study is designed to assess if computed tomography (CT, CAT-scan) enhanced with~     intravenous contrast agent (dye) can characterize a lung cancer, and say whether it is alive~     or dead. The researchers hope that in the future such a contrast-enhanced CAT-scan will make~     surgery less often necessary or improve the results of chemotherapy and/or radiation given~     before surgery.~   "
256876|NCT00188201|"~     The estimated global prevalence of hepatitis C (HCV) infection is approximately 3% (170~     million individuals). In Canada there are an estimated 240,000 people infected with HCV. The~     current study addresses the hypothesis that neurocognitive and neurochemical abnormalities~     may occur in individuals with HCV-infection who do not have liver cirrhosis or vasculitic~     neuropathy, and this may result from a direct effect of HCV on the Central Nervous System~     (CNS). The purpose of this study is to assess whether infection with the Hepatitis-C virus is~     associated with changes in thinking skills and brain chemistry, in patients who do not have~     liver cirrhosis. In addition, we are examining whether such changes in thinking skills and~     brain chemistry are reversed by antiviral treatment. We are also studying whether factors~     such as fatigue and depression have an effect on thinking skills in people with Hepatitis-C.~     In order to take into account the impact of having viral hepatitis, we will be comparing the~     results of the Hepatitis-C group to the results of a group of patients with Hepatitis-B, and~     to a group of individuals who do not have Hepatitis.~   "
256877|NCT00188188|"~     Systemic Lupus Erythematosus is a relatively common autoimmune disease that affects mainly~     women.Cardiovascular disease as a result of accelerated atherosclerosis is a major cause of~     mortality and morbidity in SLE.Previous research has shown that 35-40% of patients with SLE~     have abnormalities of myocardial perfusion even when they have no coronary stenoses on~     coronary angiography. The reason for these frequent perfusion abnormalities in the absence of~     angiographically significant CAD remains uncertain, but could conceivably result from~     endothelial dysfunction. In SLE, coronary endothelial dysfunction could result from the~     inflammatory process involved in the SLE disease itself, a finding that could explain the~     correlation between disease activity and the development of CAD in these patients.As such~     endothelial dysfunction may account for accelerated atherosclerosis and cardiac perfusion~     defects (without angiographically significant coronary lesions). We propose to first evaluate~     whether endothelial dysfunction occurs in these patients and is more frequent in patients~     with myocardial perfusion abnormalities. Endothelial function will be assessed by measuring~     flow-mediated brachial artery dilatation. In the 250 patients included in the study we will~     correlate endothelial function and myocardial perfusion abnormalities to SLE disease~     activity, to its treatment and to the presence of CAD risk factors In a subgroup of patients~     (estimated 5 patients) in whom it is clinically indicated, coronary angiography will be~     performed in order to assess the presence of significant coronary stenoses (>50%),coronary~     artery reserve and coronary endothelial dysfunction. We will then attempt to reverse~     abnormalities in endothelial function and myocardial perfusion by therapy with an ACE~     inhibitor(Quinapril).Patients with myocardial perfusion abnormalities will be randomised to~     receive Medication A(oral Quinapril or Placebo) for 8 weeks, will have all baseline~     investigations repeated and then will switch over and receive medication B(Quinapril or~     placebo) for a further 8 weeks followed by repeat investigations.~   "
256878|NCT00188175|"~     Intensity-modulated radiation therapy may make wound healing problems less likely by~     1)precisely shaping the region of high radiation dose to the shape of the tissue which~     harbours tumour cells, and 2) precisely shaping the regions of low radiation dose to the~     shapes of the normal tissues which are more sensitive to radiation effects.~   "
258349|NCT00168428|"~     This is a 60 week study including a double-blind phase followed by an open-label phase.~   "
256880|NCT00188149|"~     Prognosis of patients with Hodgkin´s lymphoma (HL) has been improved significantly over the~     last decade. Therefore, the impact of treatment associated long-term toxicities and late~     effects such as second cancers increased. The purpose of this prospective multicenter trial~     is to show the feasibility of the treatment with ABVD alone in patients with limited stage~     (HL1) and intermediate stage (HL2) disease and of an intensified etoposide-free chemotherapy~     regimen for patients with advanced disease (HL3) including 18F-FDG-PET evaluation.~   "
256881|NCT00188136|"~     Karyotype is a major prognostic risk factor in patients with acute myeloid leukemia (AML)~     translating into unfavourable outcome in case of poor-risk cytogenetic aberrations. Several~     studies have shown that allogeneic hematopoietic stem cell transplantation (HSCT) after~     myeloablative conditioning rather than autologous HSCT or consolidation chemotherapy result~     in long-term disease control in this group of patients when achieving a first complete~     remission. Nevertheless, the complete remission rate achievable is significantly lower than~     in patients with a more favourable risk profile. In fact, only the minority of AML patients~     with poor-risk cytogenetics, although having a suitable donor, proceed to HSCT due to~     refractory disease or infectious complications during induction chemotherapy (IC). Further,~     new data show that the course of therapy can be estimated as early as two weeks after the~     initiation of the first course of IC with patients presenting with more than 10 % marrow~     blasts doing significantly worse than those with a better clearance of blasts. As a result,~     the chance to obtain a durable remission is considerably low and most patients with bad-risk~     cytogenetics or failure to achieve blast clearance do not proceed to an allogeneic approach.~     Together these data indicate that early treatment intensification is warranted in order to~     provide the potential curative benefit of allogeneic HSCT to the majority of high-risk AML~     patients.~      We have shown that reduced-intensity conditioning (RIC) followed by allogeneic PBSC applied~     during aplasia after the first cycle of IC in newly-diagnosed high-risk AML patients is~     feasible and can result in a sustained disease control. These data prompted us to further~     evaluate in a prospective trial an early up-front HSCT in patients with newly-diagnosed~     high-risk AML defined by karyotype and insufficient blast clearance after the first cycle of~     IC.~      The goal was to provide an allogeneic HSCT as early as possible after diagnosis in AML~     patients.~   "
256882|NCT00188123|"~     The hypothesis is that single-shot imaging of myocardial infarction is possible in atrial~     fibrillation using MRI late enhancement technique~   "
256883|NCT00188110|"~     The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based~     on the colon distension by a high volume of warm water and a multidetector CT acquisition~     after IV (intravenous) contrast, allowing image analysis including the wall thickness and~     enhancement, the pericolic adjacent spaces and the entire abdomen.~      The goal of the study is the evaluation of its performances for the diagnosis of colon~     tumors.~   "
256884|NCT00188097|"~     The aim of the study was to determine the independent predictors of variceal bleeding and~     control of bleeding in cirrhosis as no scientific assessment have been perfomed until now~   "
256885|NCT00188084|"~     Adult acute lymphoblastic leukemia treatment approaches relie on risk stratification,~     including cytogenetics. We want to study at diagnosis several blast cells parameters on~     frozen samples of GRAALL protocols enrolled patients:~        1. A CD45-DNA double staining analysed by flow cytometry will allow mesurement for each~          blastic clone of DNA ploidy, percentage of cells in S-phase, CD45 fluorescence index.~        2. The proteine P16 metabolic way, involved in cell cycle regulation, will be studied by~          Western Blot analysis.~      The comparison between these parameters, and main haematological data, will be followed by a~     prognostic analysis, based on blast corticosensibility in vivo, chimiosensibility, complete~     remission, and survival.~      Combination of the studied parameters will allow to appreciate a clonal diversity. This will~     help to predict, at diagnosis, high probability of resistance to treatment.~   "
256886|NCT00188071|"~     -  To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the~          combination of these two analgesics~        -  each treatment beeing allocated by randomization~   "
256887|NCT00188058|"~     The aim of this multicenter randomized controlled trial is to compare the impact on mortality~     of patients mechanically ventilated for acute lung injury or acute respiratory distress~     syndrome of two strategies for setting end-expiratory pressure.~   "
256888|NCT00188045|"~     The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic~     administration (2 month) of spironolactone or propranolol, alone or in association in~     alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day,~     propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and~     splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements~     before and after 2 month of treatment.~   "
256889|NCT00188032|"~     Aims: 1) To evaluate the effectiveness of two interventions aimed at improving the management~     of patients with suspected pulmonary embolism: Written guidelines and Computer-Assisted~     Decision Support (CADS). 2) To evaluate the impact of electronic reminders on the~     appropriateness of the treatment of patients with suspected PE~      Design: Pragmatic, unblinded, cluster randomised controlled study.~      Setting: 20 French Emergency Departments~      Patients: Out patients suspected of having pulmonary embolism~      Methods: Emergency physicians will prospectively complete a standardized electronic form on~     Personal Data Assistant (PDA), including patients' characteristics, the clinical probability~     if assessed, the diagnostic tests performed, the treatments initiated and the final~     diagnostic and therapeutic decisions. Patients will be interviewed at the end of a 3-month~     follow-up period using a standardized questionnaire.~      The reference rate of appropriateness of the diagnostic management before intervention will~     be assessed in each centre. At the end of this preliminary period, the centres will be~     randomized in two fold two groups according to a factorial design with stratification on~     their reference level of appropriateness. Half of the centres will have written guidelines~     and half a Computer-Assisted Decision Support for the diagnosis of PE on the PDA. In each of~     these two main groups, half of the centres will have electronic reminders on their PDA~     concerning the treatment of PE.~      Judgment criteria~      Main : Rate of strategies considered as validated according to the results of the systematic~     review and meta-analysis.3~      Secondary judgment criteria (diagnosis):~        -  Rate of strategies considered as validated or acceptable according to the opinion of~          international advisors.~        -  Rate of thromboembolic-events during a 3-month follow-up period in patients for whom~          pulmonary embolism will be ruled out~        -  Costs of the diagnostic management~      Secondary judgment criteria (treatment):~        -  Delay between Emergency Department admission and the first dose of antithrombotic~          treatment in patients with high clinical probability of PE according to the Revised~          Geneva Score~        -  Rate of inappropriate treatment according to international recommendations for patients~          with confirmed PE.~      Number of patients: By estimating that the rate of appropriateness would be 55% in the~     written guidelines group, 1331 patients are necessary to highlight an absolute superiority~     of 15% in the CADS group (rate of conformity of 70%).~      The number of patients will be adjusted at the end of the preliminary period according to the~     level of appropriateness before interventions considering that it will improve less than 5%~     in the written guidelines group.~   "
256890|NCT00188019|"~     Hereditary paraganglioma -due to SDH (SDHD, SDHB, SDHC) germline mutations- causes~     paragangliomas and pheochromocytomas. Presymptomatic genetic testing should be offered to all~     first-degree relatives if an SDH mutation is detected in an index case with paraganglioma or~     pheochromocytoma. The main objective of our national clinical research project is to test~     different screening methods to detect presymptomatic tumors in order to establish guidelines~     for the work-up and the follow-up of SDH mutation carriers.~   "
256949|NCT00187226|"~     The purpose of the study was to determine if treating a limited volume of normal tissue~     surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar~     rates of disease control compared to standard radiation therapy. The study was also conducted~     to examine the effect of irradiation on neurological, endocrine and cognitive function.~   "
258350|NCT00168415|"~     A study using Botulinum Toxin Type A in adolescents with axillary hyperhidrosis.~   "
256891|NCT00188006|"~     The impact of the postoperative inflammatory response on the central nervous system after~     cardiac surgery is uncertain.~      The goal of this study was to evaluate the role of complement activation on cellular brain~     injury and neurological functioning in patients undergoing coronary artery surgery. In~     addition, the effect of complement activation on the cerebral vasomotricity was assessed.~      Because receptors to activated complement are present on astrocytes, the heparin-coated~     cardiopulmonary bypass that reduces complement activation should minimize these postoperative~     neurological adverse events. Heparin-coating might also influence blood flow velocity in~     cerebral arteries postoperatively if complement activation mediates cardiopulmonary bypass~     induced cerebral vasomotor dysfunction.~   "
256892|NCT00187993|"~     Hypopituitary adults with all the hormonal deficiencies are well subsituted excepted for the~     growth hormone (GH) and died earlier than the rest of the population. GH deficiency involves~     a fat mass increase with regard to lean mass, an atherogenic lipidic profile and~     participating to osteopenia mechanism and decrease the life quality. All these dysfunctions~     are partially or totally corrected by the GH prescription with patient deficient since~     adulthood.~      However, for patients deficient since childhood, no study have demonstrated that GH treatment~     during childhood present these same benefit when they are treated during adulthood.~      Primary objective of this study is to examine that fat mass significantly decrease due to GH~     treatment in adulthood for patient GH deficient since childhood, treated by GH during~     childhood but stopped since the end of adolescence.~      We compare the body composition and others energetic metabolism parameters in two patient~     groups, one treated by GH during 18 months, and the other with no treatment. Body composition~     and bone density are measured by pletysmography (DEXA). Metabolic parameters are : energetic~     balance (energy intake evaluation by questionnaire, energetic expenditure evaluated by doubly~     labelled water) and biologic parameters (lipidic profile, thyroid hormones).~      This study will evaluate if the GH treatment of young GH deficient adults since childhood can~     be a benefit for body composition, lipidic profile and bone density.~   "
256893|NCT00187980|"~     The aim of this study is to 1-evaluate subjectively by questionnaires and objectively by~     ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2-~     to correlate sleep quality index with quality of life, daytime alertness, Performans status~     and lung cancer staging at diagnosis.~   "
256894|NCT00187967|"~     Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome.~     The goal of this study is to compare blood activation induced by cardiopulmonary bypass~     performed with centrifugal pump or roller pump in patients undergoing coronary artery~     surgery.~   "
256895|NCT00187954|"~     The purposes of this study are:~        -  To correlate the severity of retinal arteriolar narrowing and other microvascular~          changes, as determined from retinal photographs and video imaging, to measures of~          coronary microvascular function in women evaluated for chest pain.~        -  To evaluate measures of vascular compliance with applanation tonometry and~          photoplethysmography using a nasal alar probe.~   "
256896|NCT00187941|"~     Individuals absorb Cellcept (MMF/Mycophenolate Mofetil) at different rates and it is~     difficult to determine an individuals level of Mycophenolate Mofetil (MMF, trade name~     Cellcept)from a single measurement. We will enroll 20 subjects. Plasma samples to be~     collected pre-MMF dose (trough level) and at 30 and 120 min after the morning dose of~     MMF.This will be done weekly for the first month and then monthly for the next 6 mths. We~     hope to use a calculation of the subjects total MMF level during the first month to set a~     trough target level to use during the next 6 months.~   "
256897|NCT00187928|"~     The purpose of this study is to determine if a drug called topiramate is safe and effective~     as an add-on therapy in the treatment of Obsessive-Compulsive Disorder (OCD). Topiramate is~     an investigational drug for OCD, which means it has not been approved by the U.S. Food and~     Drug Administration (FDA). Topiramate has been approved as an add-on therapy for adults and~     children with partial onset seizures or generalized tonic-clonic seizures, and for patients 2~     years of age and older with a severe form of epilepsy called Lennox-Gastaut Syndrome.~      Up to 96 subjects will be enrolled in this study. This study consists of three phases:~     Washout/Screening Phase, Double-Blind Phase, and Taper Phase. The total expected length of~     your participation in the study is approximately four months.~   "
256898|NCT00187915|"~     This study is a prospective interventional trial of de novo renal transplant recipients,~     aiming to validate a strategy which combines the use of early post transplant MPA AUC~     sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a~     clinically applicable fashion.~   "
256899|NCT00187902|"~     Julius Schachter, PhD, from the Department of Laboratory Medicine at UCSF, and Jeffrey~     Klausner, MD, from the Department of Public Health, are conducting a study to evaluate a type~     of test (nucleic acid amplification test) for the detection of two sexually transmitted~     diseases, Chlamydia trachomatis and Neisseria gonorrhoeae, in men who have sex with men~     (MSM), using urine samples and swabs taken from the throat (pharynx), tip of penis (glans),~     and rectum. The use of nucleic acid amplification tests on these swabs is experimental, which~     means that the use of the tests for this purpose have not been approved by the Food & Drug~     Administration.~   "
256900|NCT00187889|"~     Some women have chest pain even without having a blockage in one of the major blood vessels~     that supplies blood to the heart. In many of these women the microscopic (small) blood~     vessels in the heart do not function normally. This study seeks to determine if treatment~     with eplerenone, a commercially available diuretic, can improve the function of these~     microscopic blood vessels and, possibly, improve the chest pain.~   "
256901|NCT00187876|"~     The purpose of this study is to determine the efficacy of patellar tendon allografts that~     have undergone the BioCleanse™ process.~   "
256902|NCT00187863|"~     The purpose of this study is to determine which factors are associated with the development~     of chronic shoulder pain and disability.~   "
256950|NCT00187213|"~     The purpose of this study is to demonstrate that biventricular pacing (BiV) and left~     univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac~     resynchronization therapy in heart failure patients implanted with a cardiac~     resynchronization therapy defibrillator (CRT-D) device.~      The hypothesis to be tested by this clinical investigation is that patients indicated for an~     ICD with cardiac resynchronization therapy respond as well to LV only pacing as to BiV~     pacing.~   "
256903|NCT00187850|"~     CAP-2 Trial~      Background: This trial is being done in conjunction with an ongoing clinical trial~     investigating stepwise excavation versus final excavation on deep caries lesions (The CAP-1~     trial). The investigators lack systematic knowledge concerning the treatment of the exposed~     pulp and whether the capping of a pulp represents the same outcome as the partial removal of~     an additional 1-1.5 mm of the pulp tissue (partial pulpotomy).~      Aim: The aim of the CAP-2 trial is in a randomised clinical trial to investigate the effect~     of direct pulp capping versus partial pulpotomy in patients who, from the beginning, have~     received either a final excavation or a stepwise excavation and where this intervention has~     led to the exposure of a vital pulp and/or the patient has not gained relief from tooth pain~     after excavation and placement of a temporary restoration.~      Patients: Patients include consecutive patients with deep caries who have been participating~     in the CAP-1 trial, where the pulp exposure to a bleeding pulp is present and/or pain relief~     has not been obtained.~      Design: The CAP-2 trial is a randomised patient- and observer-blinded multicenter trial, with~     two parallel intervention groups. Patients who fulfill the inclusion criteria will be~     centrally bloc-randomised in the Copenhagen Trial Unit, Copenhagen DK, and stratified by age~     and pain. The allocation ratio is 1:1.~      The Interventions and Products: Patients are allocated for direct pulp capping or partial~     pulpotomy. The patients will not be informed about the results of the randomisation, i.e. the~     type of intervention. In both groups the patient receives a calcium hydroxide seal covering~     the exposure and a glass ionomer restoration. The final resin restoration is placed following~     4 weeks.~   "
256904|NCT00187837|"~     Brief summary~      Background:~      A large proportion of dental practice involves the treatment of caries in the permanent~     dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost~     through sickness. We do not know whether a stepwise excavation is better or worse compared~     with one final completed excavation in adults with deep caries with or without pain. A deep~     carious lesion is in the risk zone of being pulpal exposed during excavation.~      Aim:~      The aim of the CAP-1-trial is to investigate the beneficial effects of stepwise excavation~     during two visits versus óne completed excavation of deep caries in permanent teeth with or~     without pain.~      Patients:~      Consecutive patients contacting the units involved in the CAP trial for the treatment of deep~     caries. The trial will comprise 300 patients.~      Design:~      CAP-1-trial is a randomised patient- and observer-blinded multicenter trial, with two~     parallel intervention groups. Patients that fulfill the inclusions criteria and none of the~     exclusions criteria, will be centrally bloc-randomised in Copenhagen Trial Unit, Copenhagen~     DK, and stratified by age and pain. Allocation ratio is 1:1.~      Interventions and products:~      Patients are allocated for stepwise excavation in two visits or final excavation in one~     visit. The patients will not be informed about the result of the randomisation, i.e. the type~     of intervention. Therefore, all patients will be contacted for two visits. The second visit~     in the stepwise excavation group wil be used for the second and final excavation, and for the~     performance of a permanent restoration. The second visit in the one step excavation group~     will solely be used for the performance of a permanent restoration. The interventions in both~     groups are completed following 8-10 weeks after the randomisation.~      A temporary calcium hydroxide based material is used in both groups (Dycal®). The temporary~     restoration material, glas-ionomer cement is used (Ketac Molar®) in between visits, and a~     resin material is used for the final restoration(Herculite®).~   "
256905|NCT00187824|"~     The hypothesis of this study is that bioenergetic failure in human sepsis, related to~     endocrine, metabolic and mitochondrial dysfunction, is a major determinant of defective host~     immune responses, increasing disease severity and risk of death. The objectives of this study~     are to examine the relationship between the severity of illness, and temporal changes in the~     activity of endocrine, metabolic and bioenergetic pathways, and consequent immune dysfunction~     in critically ill patients with sepsis and multiple organ failure in the Intensive Care Unit.~   "
256906|NCT00187811|"~     Rstenosis is common after angioplasty of atherosclerotic disease of the femoral artery. Pilot~     study data suggests that adjuvant photodynamic therapy, using delta amino kleavulinic acid as~     a photosensitiserr is feasible and safe. This study will examine safety in a larger~     population and,if recruitment numbers allow, efficacy will be assessed.~      Hypothesis:~      ALA photodynamic therapy is safe and well tolerated as an adjuvant to angioplasty as a~     treatment for femoral artery atherosclerotic stenosis or occlusion. A secondary endpoint will~     be sought : hypothesis : PDT will reduce in restenosis rates following adjuvant photodynamic~     therapy compared with standard balloon angioplasty in the treatment of superficial femoral~     arterial disease.~   "
256907|NCT00187798|"~     Specific Aims: To compare metformin pharmacokinetics in monozygotic and dizygotic twin pairs.~     Comparing renal clearance of metformin in monozygotic and dizygotic twins will allow us to~     better understand the influence of heredity on variation in renal elimination. Furthermore,~     genotyping renal transporter genes in monozygotic and dizygotic twin pairs with significant~     differences in renal clearance of metformin may give us insight into the genes responsible~     for this variability.~   "
256908|NCT00187785|"~     Does use of a translator or use of less than perfect Spanish diminish provider-patient~     communication compared to a native speaker.~   "
256909|NCT00187772|"~     This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of~     preschoolers exposed to marital violence.~   "
256910|NCT00187759|"~     This study is to determine whether antibiotic therapy is needed for patients with non-life~     threatening soft tissue infections. Most patients with these soft tissue infections are~     presently treated with antibiotics. Many of these infections resolve without proper~     antibiotic treatment. Treatment of patients with antibiotics after surgical drainage of an~     abscess may not be necessary and indiscriminate use of antibiotics may lead to colonization~     by drug-resistant organisms. Subsequent infection by drug resistant organisms may limit the~     choice of antibiotics in more complicated infections. A comparison between antibiotic~     treatment and no antibiotic treatment in surgically treated, uncomplicated soft tissue~     infections is needed to address this very important question.~   "
256911|NCT00187746|"~     Healthy African American subjects with normal hepatic and renal function will be administered~     10mg adefovir dipivoxil in a fasting state. Subjects will have blood and urine collections~     over the following 24 hours for the measurement of adefovir renal clearance. To investigate~     the role of age in renal adefovir elimination, 8 subjects will be enrolled from each of the~     following age groups: 18-25 years and 48-55 years.~   "
256993|NCT00186654|"~     This study evaluates the efficacy of acupuncture and massage for the treatment of depression~     during pregnancy. The study also examines differential effects of study treatments on~     delivery outcome and post partum depression.~   "
256994|NCT00186641|"~     To determine survival outcomes for patients with chemosensitive brest cancer after treatment~     with high dose chemotherapy~   "
256995|NCT00186628|"~     To determine if rituximab administered after allogeneic transplantation decreases the~     incidence of chronic graft-vs-host disease (cGvHD)~   "
257206|NCT00183755|"~     This study will examine brain responses associated with reinforcement and reward tasks in~     individuals with major depressive disorder (MDD).~   "
256912|NCT00187733|"~     The current study is part of a large multi-investigator grant to look at the pharmacogenetics~     of a number of membrane transporters. Previously, the investigators have recruited a cohort~     of healthy volunteers (Studies of Pharmacogenetics in Ethnically-Diverse Populations, or~     SOPHIE) and have resequenced the coding region of a number of membrane transporter genes to~     identify genetic polymorphisms in these genes. Subjects in this cohort have agreed to be~     called back for recruitment in further studies based on their own genetic sequence, allowing~     the investigators the possibility to prospectively study the influence of genetic~     polymorphisms on particular phenotypes (i.e., genotype-to-phenotype studies). The~     investigators plan to take a genotype-to-phenotype approach to study the influence of~     specific polymorphisms in the novel organic cation transporter 2 (OCTN2) gene on carnitine~     and lipid metabolism in healthy subjects.~   "
256913|NCT00187720|"~     The current study is part of a large multi-investigator grant to look at the pharmacogenetics~     of a number of membrane transporters. We will study individuals with particular genotypes of~     the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation~     in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent,~     metformin.~   "
256914|NCT00187707|"~     The current study is part of a large multi-investigator grant to look at the pharmacogenetics~     of a number of membrane transporters. Previously, we have recruited a cohort of healthy~     volunteers (Studies of Pharmacogenetics in Ethnically-diverse Populations, or SOPHIE) and~     have resequenced the coding region of a number of membrane transporter genes to identify~     genetic polymorphisms in these genes. We plan to take a genotype-to-phenotype approach to~     study the influence of specific polymorphisms in the intestinal transporters, such as the~     novel organic cation transporters 1 and 2 (OCTN1 and OCTN2) genes on the bioavailability of~     gabapentin in healthy subjects. Eligible subjects will have a single inpatient study visit,~     during which they will take a single dose of gabapentin, and provide blood and urine samples~     over the course of 36 hours (5 terminal elimination gabapentin half-lives) for~     pharmacokinetic analysis.~   "
256915|NCT00187681|"~     Specific Objectives:~        -  To determine if individuals who carry a decreased or non-functional variant of OCT1~          exhibit differences in the pharmacokinetics of metformin in comparison to individuals~          who carry the common allele.~        -  To determine if individuals who carry the decreased or non-functional variants exhibit~          differences in the response to metformin in comparison to individuals who carry the~          common allele.~   "
256916|NCT00187668|"~     Collect DNA from well-characterized healthy volunteers.~   "
256917|NCT00187655|"~     In the proposed study, we plan to use a genotype to phenotype strategy to study the role of~     the organic anion transporter, OAT3, in drug response. More specifically we will examine the~     contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying~     individuals with a non-functional (or poorly-functional) variant of OAT3.~   "
256918|NCT00187629|"~     The purpose of this study is to determine the effects of different amounts of phosphorus in~     the diet on hormones that control phosphorus and bone health both in men who are healthy and~     in ones who have moderate kidney disease.~   "
256919|NCT00187616|"~     This trial studies whether 3 different methods of asking patients about adverse medical~     events in a clinical trial affects the rate of reported side effects.~   "
256920|NCT00187603|"~     Among all racial/ethnic groups, African Americans have the greatest risk of becoming ill or~     dying from tobacco-related diseases. Because of this disproportionate disease burden, it is~     particularly urgent that researchers focusing on tobacco control partner with African~     American communities. Intervention strategies which hold the tobacco industry accountable for~     its behavior are effective in changing views of tobacco use. In earlier work, the~     investigators found that information from internal tobacco industry documents, when shown to~     African American smokers, stimulated reflection about quitting and interest in disseminating~     information about industry targeting behaviors to others. However, to date there have been no~     attempts to utilize the information in industry documents as part of a smoking cessation~     intervention. In this project, the investigators will test whether a community co-developed,~     tailored quit-smoking program featuring exposures to African American-specific tobacco~     industry documents and media exercises in addition to proven individual quitting strategies~     can increase the number of people who quit smoking at six months and one year, as compared~     with usual care.~      The specific aims of the project are to:~        1. test, using statistics, how well an innovative community-based, culturally tailored~          quit-smoking program for African Americans works at 6 and 12 months;~        2. test selected variables for how well they predict who will return to smoking;~        3. use interviews to identify additional individual and/or community factors associated~          with successful quitting or relapse; and~        4. collect information to evaluate the overall effectiveness of the CARA project~          collaborative efforts in developing and sustaining the project over time, enhancing~          community awareness of tobacco issues, and creation or enhancement of community tobacco~          control resources.~   "
256921|NCT00187590|"~     Case management has become an integral part of HIV care. There is little science however~     demonstrating its effectiveness. This is a randomized, controlled trial of a phone call~     intervention after an ER visit to see if this can reduce further ER visits, hospitalizations,~     deaths, and cost.~   "
256922|NCT00187577|"~     This is a single center, randomized, investigator-masked study to determine the efficacy and~     safety of latanoprost and bimatoprost ophthalmic solutions in promoting eyelash growth in~     patients who have lost their eyelashes due to alopecia areata. These medications are~     FDA-approved as eyedrops for patients with glaucoma who have been noted to grow longer,~     darker, and thicker eyelashes with their use. In this study, patients will be asked to apply~     these solutions to the affected eyelid margins of one eye with a sterile cotton-tipped~     applicator once a day.~   "
256923|NCT00187564|"~     The long-term effects of high blood sugar include blindness, kidney failure, and nerve damage~     that can ultimately cause loss of limbs. Research has shown that high blood sugar increases~     the amount of reactive oxygen species (ROS) produced in diabetics, and that the increase in~     ROS causes damage to eyes, kidneys, and nerves by a process called oxidative stress. We~     postulate that alpha-lipoic acid, a potent anti-oxidant, can stop ROS from forming, thereby~     preventing long-term complications in diabetes. In this pilot study, we will be giving 30~     teenagers with type 1 diabetes (T1D) controlled-release alpha-lipoic acid for 3 months, and~     comparing the amount of oxidative stress before and after treatment. Ten teenagers with T1D~     will receive placebo instead of alpha-lipoic acid and undergo the same research protocol to~     aid in validation of outcome measures.~   "
256924|NCT00187551|"~     The goal of this study is to examine whether enfuvirtide (T20, Fuzeon) has continued anti-HIV~     activity in patients experiencing an incomplete virologic response to an enfuvirtide-based~     regimen.~   "
257278|NCT00182780|"~     RATIONALE: American ginseng may help relieve cancer-related fatigue.~      PURPOSE: This clinical trial is studying how well American ginseng works in treating patients~     with cancer-related fatigue.~   "
256925|NCT00187538|"~     Osteoporosis is a major health concern worldwide. While there are drugs available for the~     treatment and prevention of osteoporosis, they are not practical for population-wide~     prevention efforts. Demonstrating the effectiveness of safe and widely available dietary~     interventions to prevent osteoporosis could have important public health ramifications.~     Different food sources of dietary protein may have different effects on bone metabolism.~     Animal foods provide a dietary acid load that may lead to negative calcium balance and~     increased bone resorption. In contrast, vegetable sources of protein, while providing some~     acid due to their protein content, provide proportionally more base that counters the dietary~     acid load. The effect of dairy products, which are rich in animal protein but also contain~     potential base precursors not found in vegetable foods, has not been established. Finally,~     soy protein sources may have a dual benefit: soy foods provide base precursors as well as~     plant estrogens that may have a beneficial effect on bone. We are resubmitting this proposal~     to randomize postmenopausal women to one of four diets equal in calories, protein, calcium,~     and sodium. The diets will differ by having 80 percent of the protein from one of four~     sources: non-dairy animal, vegetable, dairy, or soy foods, resulting in significant~     differences among the diets in acid, base, and isoflavone content. All food will be prepared~     and provided by the General Clinical Research Center. The subjects will consume the diets for~     6 weeks with measurements of acid-base status, isoflavone excretion, and calcium metabolism.~     This will be the first intervention study to examine the effect of different sources of~     dietary protein in whole foods on calcium metabolism. Eventually our findings could have~     substantial public health implications and provide a widely available and low risk means to~     help prevent osteoporosis.~   "
256926|NCT00187525|"~     This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal~     lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this~     FDA-approved medication for Alzheimer's Disease in patients with FTLD. Secondary outcome~     measures include cognitive batteries, rating scales for activities of daily living and~     neuropsychiatric symptoms. All patients receive the FDA-approved dose of this medication for~     Alzheimer's disease.~   "
256927|NCT00187512|"~     SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide~     a specimen bank of samples with carefully characterized clinical data. SCOPE specimens will~     be used to examine multiple questions involving virologic, immunologic, and host factors~     involved in HIV-1 infection, progression, non-progression, response to treatment, control of~     HIV-1 virus, and evolution of drug resistance.~   "
256928|NCT00187499|"~     The purpose of this study is to determine whether an inhaled corticosteroid (fluticasone)~     alters the expression of any gene expressed in the lining of the airways of asthmatics. The~     study uses high density gene chips which allow the study investigators to measures all gene~     in the human genome. We hypothesize that this approach will identify novel genes that are~     affected by steroids in asthmatics.~   "
256929|NCT00187486|"~     The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma who~     have recently undergone surgery and who have not been treated with radiation therapy or~     chemotherapy. This is called a phase II study. The purpose of the phase II study is to~     determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of~     glioblastoma and gliosarcoma. All patients will receive radiation and Temodar plus Tarceva.~     There is no placebo drug.~   "
256930|NCT00187473|"~     The Major goals of this project was to assess the natural history of disease in chronic~     hepatitis C patients with normal ALT and to determine the virologic and host factors~     associated with disease severity.~   "
256931|NCT00187460|"~     Randomized cluster trial of cardiac report cards for AMI and CHF. 103 acute care Ontario~     hospitals/85 hospital corporations participating, randomized to two groups: Group A Early~     Feedback and Group B Delayed Feedback.~      Two phases of retrospective chart review of AMI and CHF separations to assess the impact of~     the public release of hospital specific performance on a set of Canadian quality indicators.~   "
256932|NCT00187447|"~     The purpose of this study is to examine if a higher dose of indomethacin will increase the~     rate of ductus arteriosus closure in extremely premature infants without increasing the side~     effects. The long term objective is to find the optimal dosing of indomethacin for permanent~     closure of the Ductus and prevent the morbidity related to PDA and the complications of~     surgical ligation.~   "
256933|NCT00187434|"~     Continuous positive airway pressure (CPAP) has been used successfully to promote extubation~     in the premature infant population. The two methods of CPAP to be examined are currently used~     by many institutions, yet no study has compared these methods to determine which is better in~     the population of newborns < 1500 grams (birth weight) at supporting extubation. This~     randomised controlled study will examine two types of CPAP: the Infant Flow System and the~     Bubble CPAP. This randomised controlled, single site, clinical study is to determine whether~     the Bubble CPAP or the Infant Flow System (IFS) CPAP is more effective at supporting the~     extubation in infants of birth weights < 1500 grams. Seventy-six infants will be randomised,~     immediately prior to extubation, to IFS or Bubble CPAP of 5 cmH2O. The primary outcome is~     successful extubation, defined as not reaching failure criteria for the 7 days~     post-extubation. Failure criteria are defined as pH < 7.25 and PCO2 > 65 mmHg or a sustained~     increase in FiO2 of 0.15.~   "
256934|NCT00187421|"~     The primary objective of the proposed study is to determine if a strategy of intraoperative~     patency assessment and graft revision can decrease the rate of graft occlusion or significant~     stenosis (>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional~     operative management without routine intraoperative patency assessment. Patency will be~     assessed with a new fluorescence angiography technique as well as ultrasonic transit-time~     flow measurement. We hypothesize that the strategy of intraoperative patency assessment and~     graft revision will significantly reduce the frequency of graft occlusion at 6-12 weeks in~     comparison to patients who do not have intraoperative patency assessment. We also hypothesize~     that the strategy of intraoperative patency assessment and graft revision will significantly~     reduce the frequency of 50-99% stenoses at 6-12 weeks in comparison to patients who do not~     have intraoperative patency assessment. We expect both groups will experience similar~     perioperative outcomes but hypothesize that patients receiving a strategy of intraoperative~     patency assessment and graft revision will experience improved long-term graft patency and~     freedom from late clinical events at 5-6 years post-operatively.~   "
257033|NCT00186108|"~     The primary purpose of this study is to evaluate the ability of oral triamcinalone given~     twice a day to patients with androgen independent prostate cancer to produce a sustained~     biochemical response. Secondary goals are to describe the safety and tolerability at this~     dose and schedule, to determine the time to sustained biochemical response, to determine the~     duration of biochemical response, to determine the time to disease progression.~   "
257034|NCT00186095|"~     To evaluate the role of nonmyeloablative allogeneic transplantation in Amyloidosis.~   "
257035|NCT00186082|"~     This study is undertaken to find out whether prophylactic antibiotics can decrease the~     infection rate in third and fourth degree perineal tear repairs done in the immediate~     postpartum period.~   "
256935|NCT00187408|"~     It is known that patients who fracture their legs sometimes develop blood clots (known as~     deep vein thrombosis) in their legs. These clots may cause pain and swelling in the leg or~     they may detach and travel to the lungs producing shortness of breath, chest pain, and~     sometimes death. Unfortunately, it is not known how frequently these complications occur~     after leg fractures, or if the use of a blood thinner medication can effectively and safely~     prevent these clots. Doctors at hospitals across Canada are conducting a study in which~     patients who have surgery for leg fractures receive either a once-daily injection of a blood~     thinner, known as low molecular weight heparin, or a placebo injection for up to 14 days~     after their fractures. Neither the patients nor the doctors know which patient is on the~     medication and which patient is on placebo. All patients receive an ultrasound examination of~     their legs at 2 weeks after surgery to monitor for deep vein thrombosis. In addition, all~     patients are checked for symptoms of leg or lung clots and any side effects of the medication~     for 3 months. If the blood thinner is shown to be effective at reducing this complication and~     documented to be safe and cost-effective in this setting it will be recommended for use in~     such patients. If, on the other hand, the frequency of deep vein thrombosis is too low to~     justify the cost or inconvenience of taking this medication, this will also be an important~     finding.~   "
256936|NCT00187395|"~     Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to~     first determine whether clinicians will comply with the interventions of 'less tight' and~     'tight' control of dBP, and whether the interventions will result in differences in mean dBP~     between groups. A pilot will also allow us to confirm the ability of centres to identify~     eligible women and the willingness of women to join CHIPS.~   "
256937|NCT00187382|"~     In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have~     not had their baby by 14 or more days after being given a single course of antenatal~     corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational~     age lower the risk of illness or death in babies compared to repeated courses of placebo.~     Children are assessed at 2 years and 5 years for neurodevelopmental impairment.~   "
256938|NCT00187369|"~     For twin pregnancies at 32-38 weeks gestation, where twin A is head down, does a policy of~     planned caesarean section (CS) lower the likelihood of death or serious illness, during the~     first 28 days after birth, compared to a plan for vaginal birth (VB)?~   "
256939|NCT00187356|"~     Bypass surgery is often required to treat severe coronary heart disease. Either arteries or~     veins can be used as bypass grafts. We wish to compare the long-term durability of the~     saphenous vein from the leg to that of the radial artery from the fore-arm when used as~     bypass grafts. We are examining how many of these grafts are still functioning beyond 5 years~     after bypass surgery by performing a coronary angiogram. After 1-year, we found that radial~     arteries were more likely to be functioning than saphenous veins. We hypothesize that radial~     arteries will continue to be superior beyond 5 years.~   "
256940|NCT00187343|"~     The purpose of this study is to determine whether the use of a 3D missing tissue compensation~     radiation technique during a standard adjuvant breast radiotherapy delivering a dose of 50Gy~     in 25 treatments could reduce significantly the occurence rate and the degree of acute skin~     reaction compared to a standard wedged irradiation technique.~   "
256941|NCT00187330|"~     N-acetylcysteine is a medication that has most commonly been used in the past to prevent~     liver damage after an acetaminophen overdose. N-acetylcysteine has also been used in patients~     with pre-existing kidney damage to prevent further kidney damage resulting from dye that is~     used in tests such as angiograms (dye studies). This study hopes to prove that this~     medication may also help to protect kidneys from the damage caused by the heart-lung machine~     during cardiac surgery. This damage to the kidneys happens to patients undergoing cardiac~     surgery requiring the use of the heart-lung machine. Kidney failure after surgery is a~     serious complication (2-30% of patients with kidney problems can develop it) and it can lead~     to short term and long-term dialysis as well as death (there is up to a 30% death rate once~     kidney failure develops). The study will test if intravenous N-acetylcysteine is safe and~     effective in preventing kidney problems after cardiac surgery using the heart-lung machine.~     Approximately 104 patients will be enrolled at Sunnybrook and Women’s College Health Science~     Centre. The study has been reviewed and approved by the ethics committee at Sunnybrook and~     Women’s College Health Science Centre. The study will compare the effects of N-acetylcysteine~     with those of placebo (salt solution). The study medication (either N-acetylcysteine or~     placebo) will be given in addition to your usual medication and surgical procedures.~   "
256942|NCT00187317|"~     This study aims to investigate the potential to train compensatory stepping and grasping~     reactions for the prevention of falls.~   "
256943|NCT00187304|"~     The primary objective of this study is to compare two different regimens of therapy, AVK and~     ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM~     Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event~     free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus~     on thromboembolic events and bleedings).~   "
256944|NCT00187291|"~     The ABCD clinical study is designed to determine if a T-Wave Alternans (TWA) test is~     equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms~     in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained~     tachycardia. Patients undergo both the TWA test and EP study and receive an Implantable~     Cardioverter Defibrillator (ICD)if either of the tests show the patient is at risk. The~     patient is then followed for 2 years. The incidence of a ventricular tachyarrhythmia events~     and total mortality are to be evaluated over the duration of the study.~   "
256945|NCT00187278|"~     The primary purpose of the study is to evaluate if patients with a standard indication for~     permanent ventricular pacing, left ventricular ejection fraction without limit, or any QRS~     duration will profit from the prevention of ventricular desynchronisation.~   "
256946|NCT00187265|"~     The purpose of this study is to evaluate the feasibility of permanent biventricular pacing~     using three ventricular leads, and its efficacy in terms of inter and intra-ventricular~     resynchronization, in patients with congestive heart failure and a non-functional atrium~     (chronic AF).~   "
256947|NCT00187252|"~     The purpose of this study is to evaluate whether adding AF Suppression™ to cardiac~     resynchronization therapy (CRT) improves the prognosis of heart failure patients benefiting~     from cardiac resynchronization therapy.~   "
256951|NCT00187200|"~     The purpose of the study is to evaluate the benefit of interventricular (V-V) delay~     optimization in reducing the non-responder rate in patients with cardiac resynchronization~     defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.~      For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH~     of the following requirements are fulfilled:~        -  < 10% improvement in 6-minute hall walk, and~        -  no class improvement or worsening in New York Heart Association (NYHA) scale.~      For those receiving CRT-D devices as replacements of older CRT-D systems, patients are~     considered non-responders if BOTH of the following requirements are fulfilled:~        -  > 1 heart failure (HF) related hospitalization, and~        -  no class improvement or worsening in NYHA scale.~   "
256952|NCT00187187|"~     The DAVID II Clinical Study evaluates the hypothesis that, in patients needing an ICD but~     without overt indications for pacing, AAI pacing with maximal concomitant drug therapy will~     not increase the rate of the combined endpoint of mortality or hospitalization for new or~     worsened heart failure as compared to patients with ventricular backup pacing.~   "
256953|NCT00187174|"~     Patients with recurrent or refractory solid tumors or brain tumors that are unresponsive to~     conventional therapy, or with no known effective therapy, will be treated. Experiments in the~     laboratory have shown the experimental drug RAD001C (RAD001, Everolimus) can prevent cells~     from multiplying. RAD001 is now being tested in diseases such as cancer, in which excessive~     cell multiplication needs to be stopped. The drug has been tested in adult cancer patients~     and has been well tolerated by subjects in these studies. It is experimental and, therefore,~     available in clinical trials.~   "
256954|NCT00187161|"~     This is a pilot study to demonstrate that the modified LMB-89 treatment regimen for children~     with newly diagnosed small noncleaved cell NHL, large cell NHL (B-cell), and B-cell acute~     lymphoblastic leukemia can be delivered in this setting with acceptable toxicity.~   "
256955|NCT00187148|"~     This protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy~     adults. DNA-based vaccines are being studied for the prevention of human immunodeficiency~     virus (HIV), malaria and hepatitis. DNA vaccines have been well tolerated in human studies to~     date. The vaccine that will be tested in this study was made from the information that the~     virus uses to make a small part of the HIV. This small part is called the envelope or coating~     around the virus. We hope the body will make an immune response against the HIV envelope~     coat. Our potential HIV DNA envelope vaccine is called EnvDNA.~   "
256956|NCT00187135|"~     St. Jude Children's Research Hospital is studying the best ways to prevent pain during and~     after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the~     spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics~     (medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers~     believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with~     applying the skin-numbing-cream EMLA or L.M.X4™ on the area where the procedure is performed,~     will provide better pain control.~      Each patient enrolled on this study will have three different anesthetic combinations for~     three different procedures, in order to determine which combination worked best for each~     child.~   "
256957|NCT00187122|"~     The main purpose of this study is to determine if it is feasible to administer an~     intensified, multi-agent chemotherapy regimen for children with stage III and IV non-Hodgkin~     lymphoma and to find out what the toxicities are.~   "
256958|NCT00187109|"~     Life-threatening thrombocytopenia (low platelet count) and neutropenia (low white blood~     count) remain the major dose-limiting toxicities following chemotherapy treatment for cancer.~     The only remedy for thrombocytopenia at present is platelet transfusion, which is effective~     in preventing life-threatening hemorrhage, but may lead to other complications. Preclinical~     studies and studies in adults have shown recombinant human thrombopoietin (rhTPO) to be~     effective in stimulating platelet production. The initial phase of this trial will evaluate~     the safety of rhTPO use immediately after chemotherapy with ifosfamide, carboplatin, and~     etoposide in children with solid tumors and lymphomas. The second phase of the study will~     evaluate the effectiveness of rhTPO in decreasing the duration of low platelet count after~     chemotherapy.~   "
256959|NCT00187096|"~     The purpose of this study is to assess the safety and efficacy of infusing natural killer~     cells from a donor as treatment for patients with acute myeloid leukemia in remission or who~     have experienced relapse.~   "
256960|NCT00187083|"~     The main purpose of this study is to find out which form of asparaginase (the native E.~     coli/Erwinia) or PEG-asparaginase) is more effective during induction treatment for children~     with acute lymphoblastic leukemia that has come back after treatment (relapsed) or is~     resistant to treatment (refractory)~   "
256961|NCT00187070|"~     The main purpose of this study is to find out if it is feasible to deliver a multi-agent~     chemotherapy regimen which features a shorter, more intensive, immunophenotype-directed~     approach, and includes an intensification phase with hematopoietic stem cell support for~     children with large cell lymphoma~   "
256962|NCT00187057|"~     This is a pilot/feasibility study designed to investigate the feasibility of treating~     children with Ataxia-Telangiectasia (A-T) and cancer with regimens nearly as intense as~     non-A-T patients with cancer would receive.~   "
256963|NCT00187044|"~     This is a research study to evaluate the safety of a vaccine to protect people from HIV~     infection. Human Immunodeficiency Virus (HIV) is the cause of AIDS (Acquired Immune~     Deficiency Syndrome). AIDS is one of the most serious viral infections of our time. It is~     believed that all persons who contract HIV will eventually develop AIDS. Because of this, we~     are trying to develop new ways to prevent infection with HIV.~      The vaccine that will be tested in this study has been prepared from a small part of the HIV.~     The part of the HIV used in this vaccine is the envelope or coating part of the virus. In~     this study, researchers will evaluate how well the vaccine is tolerated, how much vaccine~     should be given, and determine if any side effects occur in response to the vaccination.~   "
256964|NCT00187031|"~     In spite of the overall success of treating Wilms tumor, certain patients still have poor~     clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and~     recurrent Wilms tumor warrant the identification of new therapeutic agents. The objective of~     this trial is to estimate the response rate to two cycles of intravenous topotecan in~     children with recurrent Wilms tumor of favorable histology that is refractory to standard~     curative therapy.~   "
256965|NCT00187018|"~     Osteogenesis imperfecta (OI) is a genetic disease for which there is currently no known cure.~     OI causes the osteoblasts (bone-forming cells in the body) to grow poorly, which slows the~     growth of children with the disease and causes their bones to bend and break easily. Some~     forms of osteogenesis imperfecta may cause severe disability and even death. In previous~     research studies performed at St. Jude, it was found that children treated with bone marrow~     transplant (infusion of healthy immature blood-forming cells) began to grow faster, had more~     minerals (material that helps make the bones strong) in their bones, and broke their bones~     less often than before the bone marrow transplant. Several months after the bone marrow~     transplant however, body growth once again began to slow down. In this research study,~     children with osteogenesis imperfecta will receive another infusion of bone marrow cells but~     without any chemotherapy. The marrow cells will come from the same bone marrow donor as their~     previous bone marrow transplant. It is hoped that by removing the CD3+ cells (a type of white~     blood cells that attack other cells that are not like themselves) from the donated bone~     marrow, the subject's body will be infused quite safely and that body growth and bone~     strength will increase. The CD3+ cells will be removed from the donor bone marrow by use of a~     machine called the CliniMACS System. This machine has not been approved for use in the United~     States by the Food and Drug Administration (FDA). The use of this device is considered~     experimental.~   "
256966|NCT00187005|"~     The main purpose of this study is to find out if radiation to the central nervous system~     (CNS) can be safely omitted with early intensification of chemotherapy and chemotherapy given~     directly to the CNS. Another purpose is to find out if survival of children with ALL can be~     improved with risk-directed therapy given on this protocol.~   "
256967|NCT00186992|"~     Researchers at St. Jude Children's Research Hospital are looking for more effective ways to~     deliver radiation therapy to pediatric tumors of the bone and soft tissues. The goal of the~     study is to improve local control of musculoskeletal tumors with image-guided radiation~     therapy (IGRT) while minimizing radiation related side effects. IGRT uses computed tomography~     (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) images to~     precisely define tumor location and to carefully plan radiation treatment. This approach~     allows doctors to deliver highly conformal radiation therapy to the tumor while protecting~     nearby healthy normal tissues.~   "
256968|NCT00186979|"~     The purpose of this protocol is to estimate the maximum tolerated dose of gefitinib in~     combination with fixed dose of irinotecan and vincristine in patients with refractory solid~     tumors.~   "
256969|NCT00186966|"~     This is an international multicenter open label randomized phase III trial in children with~     relapsed and refractory acute myeloid leukemia (AML) such a disease. The main purpose of this~     study is to determine the efficacy and toxicity of liposomal daunorubicin when added to~     fludarabine, ara-C and G-CSF(FLAG) in children with relapsed and refractory AML.~   "
256970|NCT00186953|"~     St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to~     be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves~     to create pictures, allowing doctors and other medical professionals to see inside the~     body.~      Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's~     Research Hospital researchers want to learn the best and safest dose of this ultrasound~     dye.~   "
256971|NCT00186940|"~     This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome~     who have a history of asthma/atopy. The main purpose of this study is to establish the safety~     of this drug in patients with a history of asthma or severe allergies.~   "
256972|NCT00186927|"~     Croup is an illness of young children that is caused by a virus. With this illness, the child~     has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days,~     some children may be admitted to the hospital and a few infants may require an intervention~     to help their breathing. This illness is most often caused by a virus called parainfluenza~     virus type 1, but it can be caused by other viruses. The experimental vaccine that is being~     investigated in this study is intended to try to prevent croup caused by parainfluenza virus~     type 1. Currently, there are no vaccines to prevent this virus, or medications available to~     treat the illness once infection has occurred.~      This research study is testing a new experimental live-virus vaccine that is given by placing~     liquid drops in the nose. The Sendai virus is very similar to the virus that causes croup,~     but it has never been found to cause illness in people. Previous studies in animals have~     shown that the vaccine provided protection against the croup virus, and did not cause~     illness. Many people have been exposed to the Sendai virus, but no one has been known to~     develop illness. Several healthy adults have been given the Sendai virus vaccine being~     studied, and they did not experience any serious side effects or illness.~   "
256973|NCT00186914|"~     Osteodysplasia or poorly formed bones, brittle bones is a genetic disease with no known~     proven treatments. Some forms of osteodysplasia may cause severe disability and even death.~      Eligible patients were limited to those children with Osteodysplasia who had undergone a~     previous allogeneic bone marrow transplant at St. Jude. The study intervention involved an~     infusion of a specified number of ex vivo expanded stromal cells obtained from the bone~     marrow of the same donor from whom they received their primary transplant procedure. These~     bone marrow stromal cells can become bone-forming cells, called osteoblasts. Participants~     then received 2 infusions of ex vivo expanded, gene marked cells not less than 6 months after~     bone marrow transplantation. The second cell infusion occurred between 14 to 21 days after~     the first infusion in the absence of toxicity. The goal of the study was to evaluate the~     safety and toxicity of these infusions.~   "
257036|NCT00186069|"~     To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.~   "
257037|NCT00186056|"~     The purpose of the study is to examine the effectiveness of mifepristone treatment in~     patients with refractory depression. Refractory depression is defined as clinical depression~     that is unimproved after treatment with at least 2 different antidepressants of adequate dose~     and time trial. Mifepristone will augment current medications.~   "
257038|NCT00186043|"~     1. The primary objective of this study is to examine the efficacy of quetiapine (Seroquel)~          in treatment of dysphoric hypomania in patients with Bipolar II disorder.~        2. To evaluate the utility of Seroquel add-on treatment to decrease mixed depressive and~          hypomanic symptoms.~   "
257913|NCT00174213|"~     The purpose of this study is to estimate the validity and reliability in measuring the~     iliotibial tract by using ultrasound.~   "
256974|NCT00186901|"~     Research studies have shown that children who are long-term survivors of childhood leukemia~     may be at greater risk for early bone loss called osteoporosis. This bone loss may lead to a~     greater risk of broken bones and other spine and bone problems. However, researchers still do~     not know much about how frequently this long-term side effect may occur and how severe the~     problem is.~      St. Jude Children's Research Hospital researchers want to determine the frequency and~     severity of this side effect. They are also studying whether taking calcium and Vitamin D~     supplements can help children at risk for osteoporosis and if certain factors can be~     identified -- such as age at diagnosis, cancer treatments, or family history -- that may~     increase the chances of having osteoporosis. Researchers will take an x-ray study called~     quantitative computed tomography (QCT) to measure bone mineral density (BMD). The BMD is a~     measure of bone strength. If a subject's BMD falls below the average, he/she will be assigned~     to one of two groups. Subjects will be randomly assigned (like tossing a coin) to receive~     calcium and vitamin D pills. The other half will receive placebo pills that look like the~     calcium and vitamin D pills.~   "
256975|NCT00186888|"~     Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the~     light sensitive layer of tissue that lines the back of the eyeball; sends visual messages~     through the optic nerve to the brain. When only one eye is affected, this is known as~     unilateral retinoblastoma and when both eyes are affected, it is called bilateral~     retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based~     on the form and the stage of the disease (inside the eye or has moved outside). The main goal~     is always to cure the cancer, and save the life of the child. Treatments are also designed~     with the hope of saving the vision, while completely destroying the tumor. Therapies may~     involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal~     treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the~     tumor.~      In this study, researchers want to investigate how different participants respond to~     different therapies that are individualized specifically for them. Participants will be~     divided into three main groups, depending on whether the disease is unilateral or bilateral,~     and the stage of the disease. One of the main objectives of the study is to investigate how~     advanced tumors in children with bilateral disease respond to a new combination of~     chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results,~     some children with very advanced disease may receive carboplatin chemotherapy given around~     the eye at the same time that they receive topotecan by vein. Also, because children with~     retinoblastoma are diagnosed so early in life and the vision may be significantly impaired,~     this study will investigate how children develop and how the brain adjusts and compensates~     for the visual deficits. Finally, this study also investigates the biology of retinoblastoma,~     in order to understand better how this cancer develops.~   "
256976|NCT00186875|"~     The main purpose of this study is to find out how well participants with relapsed or~     refractory ALL respond to treatment with an etoposide- and teniposide-based induction~     chemotherapy regimen and what the side effects are.~      Primary Objectives:~        -  To estimate the response rate for patients with refractory or relapsed ALL.~        -  To estimate the survival rate of patients with refractory or relapsed ALL treated with~          risk-directed therapy.~   "
256977|NCT00186862|"~     Neuroblastoma affects approximately 500 children a year in the United States. When the tumor~     occurs in infants, it is frequently localized and responds well to therapy. Even disseminated~     disease can be eradicated in about 75% of infants, and indeed may undergo spontaneous~     remission. In older children, the prognosis is far worse, and 80% or more of those with~     disseminated tumor can be expected to relapse within 3 years.~      This study will utilize the concept of exploiting the immune system to eradicate~     neuroblastoma. In tumors in which there is consistent expression of tumor specific antigens~     as part of the malignant process, it may be possible to generate immune T-cells ex-vivo or~     in-vivo by using the specific protein or peptide(s) derived therefrom and eradicate the~     tumor. This study will evaluate the use of four to eight injections of IL-2 gene-transduced~     autologous neuroblastoma cells to induce a local, polyclonal T-cell infiltrate as well as an~     anti-tumor immune response.~   "
256978|NCT00186849|"~     This is a Phase II pilot study of chemotherapy and surgery for children with advanced stage~     high-risk neuroblastoma utilizing topotecan during an upfront window and other active agents~     during induction and intensification phases. The primary purpose is to estimate the response~     rate to an upfront window of two cycles of intravenous topotecan. We hypothesize that the~     topotecan window will be an effective therapy in terms of the response rate.~   "
256979|NCT00186836|"~     Does vaccinating hemodialysis patients with Twinrix® (combination vaccine against hepatitis A~     and hepatitis B) result in a difference in hepatitis B antibody response in comparison to the~     monovalent hepatitis B vaccine? Hepatitis B infection is an important cause of mortality and~     morbidity. Current standard vaccination practices have low efficacy levels in patients (eg.~     hemodialysis patients) who are most susceptible of infection. Efficacy of the two regiments~     will be studied.~   "
256980|NCT00186823|"~     Blood and marrow stem cell transplant has improved the outcome for patients with high-risk~     hematologic malignancies. However, most patients do not have an appropriate HLA (immune type)~     matched sibling donor available and/or are unable to identify an acceptable unrelated HLA~     matched donor through the registries in a timely manner. Another option is haploidentical~     transplant using a partially matched family member donor.~      Although haploidentical transplant has proven curative in many patients, this procedure has~     been hindered by significant complications, primarily regimen-related toxicity including~     graft versus host disease (GVHD) and infection due to delayed immune reconstitution. These~     can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens~     when the donor T cells recognize the body tissues of the patient (the host) are different and~     attack these cells. Although too many T cells increase the possibility of GVHD, too few may~     cause the recipient's immune system to reconstitute slowly or the graft to fail to grow,~     leaving the patient at high-risk for significant infection.~      This research project will investigate the use of particular pre-transplant conditioning~     regimen (chemotherapy, antibodies and total body irradiation) followed by a stem cell~     infusion from a mismatched family member donor. Once these stem cells are obtained they~     will be highly purified in an effort to remove T cells using the investigational CliniMACS~     stem cell selection device. The primary goal of this study will be to determine the rate of~     neutrophil and platelet engraftment, as well as the degree and rate of immune reconstitution~     in the first 100 days posttransplant for patients who receive this study treatment.~     Researchers will also study ways to decrease complications that may occur with a transplant~     from a genetically mismatched family donor.~   "
256981|NCT00186810|"~     This protocol studied the effect of administration of a myeloablative pretransplant~     preparative regimen followed by an infusion of donor stem cells in children with severe~     sickle cell disease. The donor graft consisted of bone marrow or cord blood derived from a~     genetically matched sibling.~      The primary aim of the study was to evaluate how well the donated cells migrated to the bone~     marrow and begin producing healthy red blood cells, white blood cells and platelets~     (engrafted), how well the recipients immune system recovered, and assess any regimen related~     toxicities including a potentially life-threatening transplant related complication called~     graft-versus-host-disease or GVHD.~   "
257208|NCT00183729|"~     This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes~     and preventing major depressive disorder in older adults who have been admitted to a~     rehabilitation hospital for a hip fracture or cardiopulmonary condition.~   "
256982|NCT00186797|"~     This study is for patients with Severe Aplastic Anemia (SAA). A stem cell transplant from a~     genetically matched sibling donor can help or cure this disease in 85 to 100 percent of~     patients. Stem cells are immature blood cells that grow to become red blood cells, white~     blood cells or platelets. A genetic match means a brother or sister has same immune type~     (HLA type) as the patient. Unfortunately, few patients have a matched sibling donor. The~     chance of negative outcomes is much higher with other types of donors.~      This study will test the success of a new approach to stem cell transplant for SAA. Patients~     in this study will receive drugs and radiation treatment to destroy their diseased bone~     marrow and to prepare them for stem cell transplant. Bone marrow is the tissue inside the~     bones where stem cells are made.Stem cells will be harvested from the blood or bone marrow of~     genetically matched unrelated donors or partially matched family donors. The stem cells will~     be filtered using a new device that is currently under study. The patients will receive large~     doses of the filtered stem cells (stem cell graft). Researchers want to find out how the~     study treatment affects patients, the disease, and the chances for survival.~   "
256983|NCT00186784|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in~     patients with depression.~      In this study, the investigators seek to increase their understanding about how rTMS improves~     depression, and to determine which form of rTMS is most effective for depression, when used~     in combination with antidepressant medication.~   "
256984|NCT00186771|"~     Schizophrenia is a chronic, severe, and disabling brain disease. Auditory hallucinations are~     the most frequent symptoms with an incident of 50% to 70% in patients.~      Transcranial Magnetic Stimulation (TMS) can significantly reduce symptoms of schizophrenia.~     TMS is capable of inducing changes in the electrical activities of the brain in humans.~      The purpose of this trial is to study the use of TMS to decrease auditory hallucinations in~     schizophrenia.~   "
256985|NCT00186758|"~     To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic~     Stimulation (rTMS)~      to determine if non-responders can become responders if treated on the other side of the~     hemisphere~      (rTMS)~   "
256986|NCT00186745|"~     Blood clots in the leg veins, known as deep vein thrombosis, are important because they may~     travel to the lung (known as pulmonary embolism) and cause death. Blood clots are treated~     with blood thinners, or anticoagulants. The preferred treatment is an anticoagulant known as~     low molecular weight heparin (LMWH). LMWH is given by an injection under the skin, which is~     convenient for patients because they can self-administer this medication at home, and no~     blood testing is required. However, LMWH is cleared from the body through the kidneys, so~     patients who have kidney failure are generally not treated with LMWH because they may be at a~     higher risk of bleeding.~      One type of LMWH, known as tinzaparin, may be less dependent on the kidneys for clearance and~     may not increase in patients with kidney failure. The investigators would like to use~     tinzaparin to treat patients who have deep vein thrombosis or pulmonary embolism, and who~     also have kidney failure.~      The purpose of this study is to determine whether the blood thinning effects of tinzaparin~     build up, or accumulate, in patients with varying degrees of kidney failure compared to~     patients without kidney failure. The blood thinning effects will be measured using a blood~     test known as an anti-Xa level. Patients will be followed over the time they receive~     tinzaparin and those patients who are found to have potentially high levels of tinzaparin~     (based on the anti-Xa level) will have their tinzaparin dose adjusted. The investigators~     believe that the levels of tinzaparin will not accumulate to potentially dangerous levels in~     a significant number of patients with kidney failure.~   "
256987|NCT00186732|"~     This study compares methods of closure for Pfannenstiel incisions commonly used during~     gynecological and obstetrical surgery. Patients are assigned to closure by either surgical~     staples or a buried suture. Information is collected on the day of surgery, post-operative~     day two and at the six-week follow up visit. The amount of pain and cosmetic result are~     compared. Infection rates will also be monitored for the two groups.~      The study hypothesis is as follows: subcuticular (buried) sutures as compared to surgical~     staples lead to decreased post-operative pain and improved cosmetic result. Infection rates~     are similar for both groups.~   "
256988|NCT00186719|"~     A breathing condition known as chronic obstructive pulmonary disease (COPD) caused by~     cigarette smoking is a major health problem. The way by which smoking leads to lung disease~     is uncertain. Recent research done in animals provides a description of specific changes~     (that is a reduction) in these immune cell types as a result of cigarette smoke exposure. The~     study you have been asked to participate in is a pilot study to see if similar changes occur~     in humans who smoke. The purpose of this study is to evaluate this new method of testing~     blood in 3 groups of 10 people: normal non-smoking subjects, subjects who smoke with no~     history of lung disease and subjects who smoke and have smoking related COPD.~   "
256989|NCT00186706|"~     Does an oral selenium supplement increase blood levels of antioxidants in patients with~     established, smoking-related lung disease?~      Members of our study group recently discovered that elevated levels of the anti-oxidant GPx-1~     may be protective against heart disease. We are studying whether selenium supplementation~     will improve GPx-1 levels.~   "
256990|NCT00186693|"~     Airway hyperresponsiveness is a characteristic feature of the asthma. It is known that there~     is an association between airway hyperresponsiveness and eosinophilic airway inflammation.~     However, even though inflammation can be reduced with appropriate asthma therapy, it is~     typical that airway hyperresponsiveness improves only modestly with treatment. The~     determinants of airway hyperresponsiveness are unclear.~      It is also not clear as to the site of airway narrowing in asthma. It is hypothesized that~     airways beyond the 4th order have the greatest resistance.~      We hope to determine the relationships between the airway inflammation, remodeling of the~     airway and airway hyperresponsiveness. Through local instillation of methacholine at~     bronchoscopy we will be able to study proximal and distal airways and the extent to which~     they constrict in vivo~   "
256991|NCT00186680|"~     Evaluate the feasibility and safety of autologous transplantation of CD34+Thy-1+~     hematopoietic stem cells afer high dose marrow ablative chemotherapy in patients with breast~     cancer.~   "
256992|NCT00186667|"~     Evaluate the clinical activity of sirolimus in combination with cyclosporine and~     corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.~   "
258557|NCT00165698|"~     To determine the effect and safety of menatetrenone on treatment of postmenopausal~     osteoporosis comparing with alfacalcidol.~   "
256996|NCT00186602|"~     Women indicate the greatest needs for counseling at the time of initial diagnosis for primary~     breast cancer. The time of initial diagnosis is also often the time of greatest need for~     information for women and their families. However, this is the time when a woman, overwhelmed~     by shock and trauma, is least likely to absorb information provided or seek new sources of~     information. An informed peer navigator with carefully trained communication skills can judge~     the level of information to disclose and pace that information in a way that can be easily~     absorbed and understood. She will also provide support. WomenCARE, a well-established Santa~     Cruz agency providing free support services for women with cancer, and the Psychosocial~     Treatment Lab at Stanford therefore ask whether women newly diagnosed with breast cancer will~     improve their quality of life by participating in a peer navigator program. WomenCARE's peer~     navigators provide emotional support, good listening skills, and information on resources for~     women just diagnosed with breast cancer. Having a peer counselor while a woman goes through~     treatment may reduce the magnitude of distress or shorten its time course. It may also reduce~     distress in family members, and improve relationships with medical personnel.~      This study is designed to evaluate the effectiveness of a peer navigator program where a~     woman newly diagnosed with breast cancer is carefully matched for 3 to 6 months after~     diagnosis with a trained volunteer who is herself a breast cancer survivor. Navigators and~     Sojourners (newly diagnosed women) are matched on things that are important to them. Women~     often want to be matched on the type of surgery or treatment they have received. We assign~     half of the women (by a process similar to a coin toss) to our peer navigator program and~     half to a group that receives standard medical care but no peer navigator. In this way we can~     compare the groups to see whether those matched with a peer navigator have better quality of~     life over the 3 to 6 month period. All women who join our study, regardless of the group to~     which they are assigned, get an extra consultation with a nurse specialist at a local~     hospital. In this consultation, the nurse reviews the cancer resources available to the woman~     in Santa Cruz County. This meeting is tailored to the woman’s individual diagnosis and~     situation.~   "
256997|NCT00186589|"~     To test a new way to approach hematopoietic stem cell transplantation for Relapsed or~     Resistant Non-Hodgkin's Lymphoma.~   "
256998|NCT00186576|"~     To improve survival outcomes for patients with MDS and MPD with a nonmyeloablative allogeneic~     hematopoietic cell transplant.~   "
256999|NCT00186563|"~     This study aims to establish a novel approach assisting the rational development of analgesic~     and anti-inflammatory drugs. In a first step we will test in healthy human volunteers whether~     proteins mediating inflammation and pain can be detected in an experimentally induced~     inflammatory skin lesion. Fluids that will be used to detect such proteins will be collected~     from the inflamed skin site via small porous catheters. We wish to establish the expression~     pattern of different proteins and correlate it with various tests assessing pain.~   "
257000|NCT00186550|"~     This study will examine the effectiveness of supportive-expressive group therapy plus~     education compared with an educational intervention in improving the quality of life and~     promoting health-enhancing behavior of men and women living with HIV or AIDS.~   "
257001|NCT00186537|"~     Approximately 1/4 of the US population has insulin resistance and the associated risk factors~     such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver~     produces and low HDL cholesterol which is the good cholesterol helping to protect against~     heart disease. Currently one known treatment for this a medication called fenofibrate,~     another medication that can improve insulin resistance is rosiglitazone, a third treatment~     known to improve insulin resistance an decrease triglycerides is weight loss. In this study~     insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to~     HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of~     these treatments and results of insulin sensitivity and cardiac risk profiles will be~     compared at the end of the study.~   "
257002|NCT00186524|"~     Women with primary breast cancer may benefit from participating in supports groups as they~     cope with treatment and the psychological challenges of survivorship. Studies have documented~     that these women benefit from support groups run in a university setting; however, no one has~     documented that they benefit from community cancer support groups. Many community cancer~     support groups exist and provide service to a large number of women with breast cancer. It is~     important to know if these groups are providing comparable service to well researched support~     groups. We conducted this study as the first randomized study of community compared to~     university-style support groups. Women had a 50/50 chance of being assigned to either a~     community or a university style support group based on a coin flip. This study took place in~     two sites The Wellness Community East Bay (Walnut Creek) and San Francisco. Two community~     groups were studied.~      i) This study evaluated the strengths and weaknesses of two community-based support group~     interventions for breast cancer patients [The Wellness (TWC) and Cancer Support (CSC)~     Communities, in the San Francisco area]. We compared them with a type of therapy developed in~     the university setting (Stanford's Supportive-Expressive group therapy), studied which~     aspects are most effective, and who benefits the most. We compared these women on change in~     emotional distress, means of coping with cancer, and social and family support. In addition,~     change in physiological response to stress was measured using saliva samples.~      ii) We were able to achieve recruitment for 6 of 8 groups proposed. We randomized 72 women in~     blocks of 12 taking consecutive women per site until we accrued 12 for each group. Of those,~     61 women actually attended groups, of those 46 women to date completed at least one follow-up~     and were available for analysis for this report. We screened 108 women, 16 who were screened~     out on initial phone contact, 20 women began to go through our baseline interviews and~     assessments and either decided not to enroll or dropped out before we could compose a group~     for the second S.F. randomization. Our final two follow-up assessments for our final group in~     the East Bay are being conducted right now (8 month) and will be conducted in October, 2002~     (12 month) so they are not available for assay or analysis for this final report.~      iii) We examined 5 outcome variables for this report and found that women participating in~     the community groups changed at about the same level over the 4 months of group therapy as~     the women in the Stanford groups. This was true for depression symptoms, trauma symptoms,~     social support, self-efficacy, and post-traumatic-growth. These analyses are preliminary~     until we complete our final follow-up assessments. It is encouraging for the community groups~     that women benefited at the same rate as they did in the well-researched Stanford groups.~     Conclusions for this study are somewhat limited because we could not complete the recruitment~     of our entire sample. However, there is every reason to suppose that community groups are as~     effective at serving women with primary breast cancer as Stanford's groups though they are~     based on very different ideas of therapy. It is important to note that all of these groups~     were led by therapists, and that we may have found other results if the groups had been led~     by peers or other types of professionals. This study reduces the human and economic cost of~     breast cancer in California by validating community groups usually offered free to women with~     breast cancer.~   "
257003|NCT00186511|"~     The major goal of this project is to test the feasibility and acceptability of using~     videoconferencing to provide support groups led by trained facilitators to rural women with~     breast cancer in northern California.~   "
257004|NCT00186498|"~     The purpose of this study is to determine whether taking the medication memantine reduces~     impairment of memory and attention associated with electroconvulsive therapy.~   "
257005|NCT00186485|"~     We hope to learn whether this stimulation of neurons in the front part of the brain may~     relieve depression.~   "
257006|NCT00186472|"~     Infants born premature face numerous medical problems, causing significant anxiety for their~     parents. Parents experience a range of negative emotions including concern for the health and~     well being of their fragile infant, guilt, and disappointment. Research has indicated that~     having an infant in the Neonatal Intensive Care Unit (NICU) is highly stressful for parents~     and multiple studies have demonstrated that parents can develop significant psychological~     reactions to this experience. Specifically, many parents develop clinically significant~     anxiety disorders such as acute stress disorder (ASD) and posttraumatic stress disorder~     (PTSD). This not only impacts the mental well-being of the parents, but also can lead to~     problems with the parent-infant relationship, and, in turn, negatively impact the infant and~     the family as a whole. Despite the reported negative effects parents experience due to the~     stress of having an infant on the NICU, surprisingly little research has examined how to~     reduce parents' symptoms of anxiety. Because parents play an essential role in the care of~     their infant after discharge from the NICU, treating the parent's emotional distress is~     highly important. The purpose of this study is to examine the efficacy of a~     cognitive-behaviorally based intervention in reducing parents' symptoms of anxiety associated~     with having an infant on the NICU. This treatment is modeled after treatments that have~     proven effective with parents of children with other types of medical problems, for example,~     parents of children with cancer. It is the hope of the investigators that this intervention~     will effectively reduce symptoms of anxiety of NICU parents as well as the likelihood of~     developing subsequent psychological disorders.~   "
257056|NCT00185783|"~     The purpose of this pilot study is to (1) examine the changes in gene expression in patients~     who suffer from severe sepsis and whose shock (inadequate oxygen delivery to vital organs)~     state does not respond to fluid and vasopressor administration, (2) to show that our sampling~     method of isolating RNA provides reliable and consistent data, (3) provide a basis for future~     gene expression studies in critically ill patients~   "
257057|NCT00185770|"~     Randomized controlled trial to test the efficacy of reducing television, videotape and video~     game use to prevent obesity, increase physical activity, improve physical fitness, and~     decrease dietary fat and calorie intake among third grade children in twelve~     ethnically-diverse elementary schools.~   "
257058|NCT00185757|"~     The purpose of the study is to determine if the use of activated T cells can effectively~     treat relapsed disease following allogeneic hematopoietic cell transplantation without~     causing GVHD.~   "
257209|NCT00183716|"~     This study will determine the effectiveness of the Trauma Recovery and Empowerment Model in~     reducing the severity of post-traumatic stress disorder symptoms in women with mental~     disorders and who have experienced sexual or physical abuse.~   "
257007|NCT00186459|"~     The goal of the study is to define the roles played by resistance to insulin-mediated glucose~     disposal (insulin resistance) and circulating plasma insulin concentrations in: 1) ability to~     lose weight; 2) reduction of risk for coronary heart disease as a result of weight loss. We~     hypothesize that in the setting of caloric restriction, manipulating endogenous insulin~     concentrations will not alter ability of subjects to lose weight, but will lead to different~     reduction in CHD risk factors. To test this hypothesis, two parallel studs will be performed.~     First, obese insulin-resistant individuals will be randomized to one of two~     equally-hypocaloric diets that vary moderately in proportion of carbohydrate and~     mono/polyunsaturated fats (lower carbohydrate diet will be associated with greater reduction~     in endogenous insulin secretion). Second, diabetics treated with insulin secretagogues will~     be compared to diabetics treated with insulin sensitizers with respect to the same outcomes~     (secretagogues increase insulin secretion and insulin sensitizers decrease insulin~     concentrations). Endpoints include weight loss, change in insulin resistance, blood pressure,~     lipid and lipoproteins, markers of endothelial function, daylong insulin and glucose~     concentrations: these will be compared, in each of the parallel studies, between the group~     with insulin-stimulating intervention vs the group with the insulin-sparing intervention.~   "
257008|NCT00186446|"~     The purpose of this study is to assess the safety and feasibility of concurrent treatment of~     nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV~     criteria for both nicotine dependence and acute major depression will be given~     pharmacological treatment for both disorders at the same time, along with a brief behavioral~     intervention for smoking cessation.~   "
257009|NCT00186433|"~     1. To determine the prognostic implication of plasma Epstein-Bar Virus (EBV) DNA~          concentrations, as measured by quantitative polymerase chain reaction (PCR) in patients~          with nasopharyngeal carcinoma (NPC).~        2. To relate pretreatment plasma EBV DNA concentration to WHO classification of these~          tumors both in endemic and non-endemic areas.~        3. To determine whether pretreatment plasma EBV DNA can serve as a prognostic factor for~          both endemic and non-endemic patient populations.~   "
257010|NCT00186420|"~     The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with~     high risk prostate cancer after definitive therapy.~   "
257011|NCT00186407|"~     To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for~     amyloidosis.~   "
257012|NCT00186394|"~     To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of~     NHL.~   "
257013|NCT00186381|"~     Evaluate the role of high dose chemotherapy with autologous hematopoietic cell~     transplantation for AML.~   "
257014|NCT00186368|"~     The purpose of this study is to investigate gene expression profiles and biologic features of~     prostate tissue and how they relate to prostate cancer development and growth.~   "
257015|NCT00186355|"~     To evaluate the role of purging the hematopoietic cell graft on outcomes for non-Hodgkin's~     Lymphoma.~   "
257016|NCT00186342|"~     The purpose of this study is to determine the tolerability and efficacy in treating patients~     aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or~     myeloproliferative disorders (MPD).~   "
257017|NCT00186329|"~     Many patients with exacerbations of heart failure have significant concomitant kidney~     dysfunction. The combination of these two conditions makes pharmacological management~     difficult. In this study, we plan to randomize patients with heart failure and kidney~     dysfunction to receive infusions of Natrecor (B-type Natriuretic Peptide)--which may be~     beneficial to the management of these two diseases--or placebo.~   "
257018|NCT00186316|"~     Patients with Multiple myeloma who have undergone non-myeloablative allogeneic stem cell~     transplant will receive 6 vaccinations of donor derived dendritic cells combined with~     specific protein produced by multiple myeloma.~   "
257019|NCT00186303|"~     To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell~     transplantation for the treatment of chronic lymphocytic leukemia.~   "
257020|NCT00186290|"~     To evaluate the role of ablative allogeneic hematopoietic cell transplantation in the~     treatment of advanced leukemia or lymphoma.~   "
257021|NCT00186277|"~     To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in~     bladder cancer.~   "
257022|NCT00186264|"~     The primary purpose of this study is to examine whether IV hydrocortisone can speed up the~     time required for Venlafaxine XR to work.~   "
257023|NCT00186251|"~     To evaluate the role of high dose chemotherapy with autologous hematopoietic cell~     transplantation in the treatment of Hodgkin's Disease.~   "
257024|NCT00186238|"~     To assess the role of autologous hematopoietic cell rescue in the treatment of multiple~     myeloma.~   "
257025|NCT00186225|"~     To evaluate the use of unrelated donors for hematopoietic cell transplantation in the~     treatment of hematologic and lymphoid malignancies.~   "
257026|NCT00186212|"~     Evaluate the effects of a workbook/journal for helping isolated women to cope with breast~     cancer.~   "
257027|NCT00186199|"~     Determine if the pattern of voiding differs in children with vesicoureteral reflux (VUR)~     compared to those who do not have VUR.~   "
257028|NCT00186186|"~     The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar~     depression and to evaluate metabolic and GABA changes with Depakote ER administration using~     PET and MRI/MRS brain imaging techniques.~   "
257029|NCT00186173|"~     The purpose of this study is to learn whether overweight children who participate in an after~     school sports program improve their health as much as overweight children in a more~     traditional health education program.~   "
257030|NCT00186147|"~     The purpose of this study is to obtain tissue samples for ongoing studies regarding~     transplant outcomes and complications.~   "
257031|NCT00186134|"~     The purpose of the proposed study is to determine the effect of walking to school for one~     week on total physical activity and patterns of physical activity in third, fourth and fifth~     grade students.~   "
257032|NCT00186121|"~     To evaluate the antitumor activity, toxicity, and effectiveness of the combination of~     goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with~     hormone receptor positive metastatic carcinoma of the breast.~   "
259549|NCT00152490|"~     A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's~     disease~   "
257039|NCT00186030|"~     This two-year study tested the concept that an intervention, which reduces trauma-related~     symptoms among adults who are living with human immunodeficiency virus (HIV), are~     experiencing trauma-related stress symptoms, and engaging in behavior that facilitates HIV~     transmission, can reduce the transmission risk of (HIV). Our central premise was that by~     first treating trauma symptoms, we would enhance the effects of a skills-building HIV risk~     reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal,~     dissociation, and avoidance.~      The study aims were to:~        1. To determine if decreasing trauma-related stress symptoms improves HIV risk reduction~          behavior above a standard HIV risk reduction intervention alone post-intervention and 3~          months after the small group intervention sessions;~        2. To determine whether key variables moderate the intervention’s effects. For instance,~          gender, age, ethnicity, or psychological distress (e.g., depression, anxiety) may~          interact with the intervention to affect risky sexual or drug-related behavior; and~        3. To determine whether there is evidence that the theoretical mediator variables, which~          include trauma-related stress symptoms, self-efficacy, communication skills, and social~          support mediate the intervention’s effects on outcomes. This information addresses the~          theoretical question of why the intervention works.~   "
257040|NCT00186017|"~     We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S~     in a one-week randomized double-blind study. We will also assess the effect of olanzapine~     added to prior treatment on CGI-S in an eight-week open treatment study. In addition, we will~     assess the effect of olanzapine on Young Mania Rating Scale (YMRS), Hamilton and~     Montgomery-Asberg Depression Rating Scales (HDRS, and MADRS), and Hamilton Anxiety Rating~     Scales (HARS) in the above paradigms. We will also assess the influence of presentation~     severity (CGI-S) and polarity (mood elevation versus depression) on olanzapine response.~     Finally, we will assess safety and tolerability of olanzapine in the above paradigms.~      We hypothesize that in diverse mild syndromal and subsyndromal exacerbations of BD in~     outpatients, randomized double-blind flexibly dosed olanzapine added to prior treatment~     (including no treatment) will yield greater CGI-S improvement than placebo by the end of one~     week, and that such improvement will persist over one week of open continuation treatment.~   "
257041|NCT00186004|"~     We wish to find out if in non-diabetic pregnancies, as well as diabetic pregnancies,~     additional data obtained by Continuous Glucose Monitoring improves perinatal risk prediction.~   "
257042|NCT00185991|"~     To compare once daily versus 8 hour dosing of gentamicin for the treatment of~     chorioamnionitis.~   "
257043|NCT00185978|"~     To develop and evaluate, in a randomized controlled trial, a comprehensive obesity prevention~     program for third, fourth and fifth grade students.~      The intervention includes activities in THE SCHOOL, THE HOME, and a clinically oriented~     component for HIGH-RISK CHILDREN. In addition, the intervention will be delivered over a 3~     year period, with age and grade-appropriate components for 3rd, 4th and 5th graders and their~     families. The primary outcome is body mass index.~      PRIMARY OBJECTIVE: To significantly reduce body mass index, compared to controls, at the end~     of the three year intervention.~   "
257044|NCT00185965|"~     Brief summary TBD~   "
257045|NCT00185952|"~     Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor~   "
257046|NCT00185939|"~     This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in~     the management of uncomplicated dog bites, utilizing currently best available antibiotics~     (Augmentin) and an important clinical outcome of infection.~      By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan~     to utilize the point estimates of infection, side effects and other important outcomes and~     incorporate these into a cost most to determine the most cost effective management of these~     wounds and to determine if further study is warranted based on the findings.~   "
257047|NCT00185913|"~     The purpose of the study is to identify a surrogate serum marker for tumor hypoxia in~     patients with lung cancers.~   "
257048|NCT00185900|"~     To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm~     labor~   "
257049|NCT00185887|"~     To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation~   "
257050|NCT00185874|"~     Up to twenty-two patients will be enrolled in this study to receive autologous dendritic~     cells (DCs) administered intratumorally into liver metastases following radiofrequency~     thermal ablation of those lesions. Patients will receive two vaccinations of DCs at monthly~     intervals. A dose escalation study of DCs will be included in this study in an attempt to~     define the maximum tolerated dose of administered DCs.~   "
257051|NCT00185861|"~     To investigate the safety of delivering arsenic trioxide (ATO) in combination with~     stereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase I~     dose escalation trial. Results from this study will provide a basis for further study of ATO~     combined with radiation therapy as a radiosensitizer for malignant brain tumors in future~     Phase II studies.~   "
257052|NCT00185848|"~     The purpose of this study is to determine whether [18F]FHBG is suitable for use as an imaging~     probe in cancer or rheumatoid arthritis patients enrolled in cell or gene therapy trials. In~     this phase 1 study we will assess the safety and biodistribution of [18F]FHBG in patients.~   "
257053|NCT00185835|"~     To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839~     in combination with cisplatin and radiation therapy in patients with local-regional recurrent~     squamous cell cancer of the head and neck.~      To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal~     transduction pathway gene expression in tumor cells in patients with local-regional recurrent~     squamous cell cancer of the head and neck using micro array analysis from tumor samples taken~     at the time of relapse and during treatment.~   "
257054|NCT00185809|"~     The purpose of this study is to examine breast cancers that express the protein (NIS) that~     may be found in malignant breast tissues and to evaluate proteins found in blood and their~     relationship to NIS, to test whether iodide can be concentrated by breast cells to possibly~     treat some breast cancers with radioactive iodine, and to calculate the amount of radioactive~     iodine entering breast cancer cells, how long your cancer retains the agent as well as how~     much is taken up by other organs, particularly the thyroid gland.~   "
257055|NCT00185796|"~     To evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly~     patients with advanced stage MDS and MPD.~   "
257059|NCT00185744|"~     To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity~     plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite~     device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a~     feasible and safe alternative to a six and a half week course of whole breast radiotherapy.~     The study will measure both short and long-term complications of radiation treatment, short~     and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional~     recurrences, distant metastases, and overall survival.~   "
257060|NCT00185731|"~     This is an approach which can inflict significant toxicity. An alternative is to block~     expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach~     which could reduce toxicity to the host while maximizing destruction of the~     oncogene-dependent malignant cells.~   "
257061|NCT00185718|"~     To understand the impact of treatment induced menopause on quality of life and sexuality~     following blood and marrow transplantation.~   "
257062|NCT00185705|"~     In this study, we propose using telmisartan, an angiotensin II receptor antagonist with~     PPAR-gamma modulating activity, for a 12-week period to decrease blood pressure and insulin~     levels in obese, hypertensive children. Telmisartan is currently approved for treatment of~     adult hypertension. Recent adult studies, however, have shown telmisartan as an effective~     medication for lowering insulin levels and improving insulin sensitivity. We will enroll 30~     obese adolescents, ages 10 to 18 years, and randomly assign half of the group to receive~     telmisartan and the other half to receive placebo (sugar-pill). We will obtain fasting~     glucose and insulin levels, as well as other markers for insulin sensitivity and cholesterol~     panel, at the beginning of the study, at each clinic visit in 4-week intervals, and at the~     end of the study. We will obtain an imaging study (computed tomography, CT scan) on 10~     randomly selected study patients (5 from each group) to examine the distribution of fat~     tissue before and after treatment. Studies suggest that fat tissue in the subcutaneous tissue~     is less harmful that fat tissues surrounding internal organs, such as the liver. We will also~     provide nutritional handouts and exercise recommendations to each participant as a life-style~     intervention. Each participant will be given a diary to record his or her diet and exercise~     activities throughout the study.~   "
257063|NCT00185692|"~     The purpose of the study is to evaluate the feasibility and safety of transplanting CD34+~     selected hematopoietic cells from a haploidentical related donor following a nonmyeloablative~     regimen of total lymphoid irradiation (TLI) and antithymocyte globulin (ATG).~   "
257064|NCT00185679|"~     To assess the proportion of patients with donor neutrophil engraftment within 30 days of~     allogeneic transplant. To assess the incidence of acute GvHD during the first 100 days after~     transplantation.~   "
257065|NCT00185666|"~     The purpose of this study is to determine the usefulness of Cyberknife precision radiation in~     eliminating or preventing the further growth of spinal tumors and lesions.~   "
257066|NCT00185653|"~     The purpose of the study is to determine the toxicity and feasibility of non-myeloablative~     allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.~   "
257067|NCT00185640|"~     To measure how frequently and to what degree a complication of transplant cell acute graft~     versus host disease (GvHD) occurs.~   "
257068|NCT00185614|"~     Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to~     decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish~     mixed chimerism using low dose total body irradiation along with immunosuppression using~     cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to~     allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host~     disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to~     convert the patient to a full chimera while developing a graft-vs-tumor effect.~   "
257069|NCT00185601|"~     The purpose of this study is to determine of the effectiveness of an Internet based Diabetes~     Self-Management workshop for people with type II diabetes. Half of the people who complete~     the workshop will be invited to continue their education by participating in a email~     discussion group. Thus, we will be able to learn both the efficacy of the original program as~     well as its efficacy when reinforced by the discussion group.~      Diabetes is a disease that must be managed day by day by the individual with the disease.~     Although we know a great deal about the self-management of type II diabetes, most~     self-management is less than optimal. In addition, most people with diabetes do not have an~     opportunity to participate in formal diabetes education. This study will determine if an~     Internet delivered educational workshop will help people with diabetes manage their disease.~     Thus we will be measuring changes in behaviors, changes in symptoms and changes in HbA1c,~     blood pressure, cholesterol, and weight. If successful the workshop will serve as a prototype~     for Internet diabetes education.~   "
257070|NCT00185588|"~     The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine~     in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable~     pancreatic cancer. The Phase II part of this study planned to determine the antitumor~     activity of this regimen and its effectiveness of preventing tumor growth and spread.~   "
257071|NCT00185575|"~     The purpose of this study is to test the hypothesis that duloxetine (Cymbalta), in doses of~     60 or 120 mg/day, is an effective and tolerable treatment for adult outpatients suffering~     from dysthymia. Dysthymia is chronic, mild depression characterized by feeling sad or low~     more days than not for more than 2 years.~   "
257072|NCT00185562|"~     A 12 week trial of Adalimumab in subjects with active erosive inflammatory OA who have ahd an~     inadequate response to NSAID therapy~   "
257073|NCT00185549|"~     The purpose of this study is to evaluate the impact of an internet based program for children~     and families (CF.DOC) with Cystic Fibrosis on health outcomes. The program provides for~     virtual visits, a personal health record, messaging with clinicians and several tools for~     monitoring self-care behaviors. We anticipate that this intervention will provide for more~     intensive monitoring and feedback of self-care behaviors and will lead to improved health~     status and in particular nutritional status~   "
257135|NCT00184678|"~     This trial is conducted in Europe. Growth Hormone in young adults with growth hormone~     deficiency in childhood. This trial compares a treated group of patients with an untreated~     group of patients.~   "
258302|NCT00169052|"~     This study will evaluate the effectiveness of a health management and supported~     rehabilitation intervention in treating serious mental illnesses in older people.~   "
257074|NCT00185536|"~     To test whether young children’s actual taste preferences are influenced by the natural~     marketing environment in which they live. To do so, we tested whether preschool children~     would like the taste of a food more if they thought it was from a heavily marketed source. We~     asked preschool children to taste identical foods in packaging from this heavily marketed~     source and plain packaging, and to tell us if they tasted the same or if one tasted better.~     We hypothesized that, even among a sample of 3-5 year olds participating in Head Start, a~     federally-sponsored preschool program for low-income families, young children would prefer~     the taste of foods perceived to be from the heavily marketed source.~   "
257075|NCT00185523|"~     The purpose of the study is to evaluate the overall and disease free survival of recipients~     who have received G-CSF mobilized stem cells from HLA matched sibling donors.~   "
257076|NCT00185510|"~     Purpose of the study:~      One bothering feature of atopic dermatitis is its relapsing nature. Hence, it is worthwhile~     to test modes how to efficiently prevent relapses or at least increase the time until the~     disease recurs. In order to give recommendations to other patients, this study is to~     scientifically describe efficacy and safety of a given regimen, namely a maintenance therapy~     with two days a week Advantan.~   "
257077|NCT00185484|"~     The purpose of this study is to determine whether the study drug is effective in prevention~     of pregnancy in healthy women in reproductive age~   "
257078|NCT00185458|"~     The study has been designed to look at the transfer from using LNG IUS for contraception~     only, in reproductive age to using it for endometrial protection in menopausal age. The main~     area of interest in the study is the pattern of any vaginal bleeding that occurs.~   "
257079|NCT00185445|"~     The purpose of the study is to demonstrate that oral fludarabine phosphate is comparable to~     i.v. formulation used in combination with mitoxantrone in terms of efficacy, safety and~     risk/benefit profile~   "
257080|NCT00185419|"~     The purpose of this study is to evaluate the effectiveness in terms of prevention of~     pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in~     healthy Chinese women~   "
257081|NCT00185393|"~     The aim of the study is to test [90]Y-ibritumomab tiuxetan, a radioactive antibody, in~     patients with stage III or IV follicular lymphoma whose disease is in partial or complete~     remission after first line chemotherapy. The radioactive antibody will be compared with no~     further treatment to see which is better in the long term after standard lymphoma treatment.~   "
257082|NCT00185380|"~     The purpose of this study is to investigate if drug doses lower than the one released from~     Mirena® would be as effective for contraception as Mirena®. Subjects participating in the~     study will be randomly assigned to be inserted with any of the three different intrauterine~     systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from~     them is different.~   "
257083|NCT00185367|"~     The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new~     four-phasic oral contraceptive in comparison to a reference OC.~   "
257084|NCT00185354|"~     The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH~     P00331F to a marketed comparator.~   "
257085|NCT00185341|"~     This study was designed as a proof-of-concept trial to evaluate safety, tolerability, and the~     efficacy of 1800 mg (ZK 811752 600 mg given orally three times daily) over 12 weeks for the~     treatment of endometriosis associated pelvic pain (EAPP) in comparison to placebo.~   "
257086|NCT00185328|"~     To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women~     with hot flushes and other climacteric symptoms.~   "
257087|NCT00185315|"~     The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol~     inhalation therapy in patients suffering from pulmonary hypertension.~   "
257088|NCT00185302|"~     Primary objective: To evaluate the efficacy of two different dosing schedules of MS-275 in~     subjects with metastatic melanoma Secondary objectives: To evaluate the safety and to assess~     the pharmacokinetic profile of MS-275 in subjects with metastatic melanoma~   "
257089|NCT00185289|"~     The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic~     preparation in the prevention of pregnancies in a large group of volunteers.~   "
257090|NCT00185276|"~     The purpose of this study is to look at the safety (what are the side effects) and efficacy~     (how well does it work) of Magnevist (the study drug) used for MRI of the infrarenal aorta~     and peripheral arteries. The results will be compared to the results of MRI taken without~     Magnevist, and with the results of your X-ray angiography.~   "
257091|NCT00185263|"~     The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4~     is effective in improving exercise capacity measured by exercise treadmill testing, angina~     functional class, patient symptoms, quality of life, and cardiovascular outcomes. To doses~     are to be studied, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response~     of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.~   "
257092|NCT00185250|"~     Chronic viral cardiomyopathy is a disease where the cardiac muscle is attacked by a virus and~     this may result in a reduction in the output of the heart (pump function) thereby causing~     complaints such as chest pain, shortness of breath and palpitations.~      Betaferon (interferon beta-1b) is marketed for the treatment of Multiple Sclerosis already,~     but until now, it has not been proven whether it is also effective in patients with chronic~     viral myocardial disease.~      This study will be conducted to examine the efficacy and safety of Betaferon in patients with~     this disease. The aim of the treatment is to eliminate the virus from the heart so that the~     heart function and clinical status can gradually improve.~   "
257093|NCT00185237|"~     150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and~     exclusion criteria will be enrolled in the study. The women will be randomly assigned to one~     of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch~     once a week for 12 weeks.~   "
257094|NCT00185224|"~     The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma~     lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic~     parameter following the long term administration of SH T00658ID will be assessed.~   "
257210|NCT00183703|"~     This study will examine how various factors, such as psychiatric symptoms, gender, quality of~     life, and attitudes toward medication, affect treatment adherence in individuals with rapid~     cycling bipolar disorder.~   "
257095|NCT00185211|"~     This study will primarily compare the long-term effects of an early and continued treatment~     with Betaferon/Betaseron (patients who were treated with active medication during the~     double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple~     Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with~     placebo during the double-blind BENEFIT study).~      Analyses are based on the integrated data of the initial BENEFIT study and this follow-up~     study.~   "
257096|NCT00185198|"~     The purpose of this study is to investigate the effect of a testosterone replacement therapy~     called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and~     other symptoms of PADAM and safety will be studied.~   "
257097|NCT00185185|"~     This is a study in hypertensive patients with atherosclerosis and increased cardiovascular~     risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.~   "
257098|NCT00185172|"~     To test the efficacy and safety of olmesartan in patients with essential hypertension.~   "
257099|NCT00185159|"~     This is a study in diabetic patients with at least one additional cardiovascular risk factor~     and normoalbuminuria prior to randomization.~   "
257100|NCT00185146|"~     The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be~     assessed using carotid ultrasound~   "
257101|NCT00185133|"~     This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus~     amlodipine in mild to severe hypertensive patients older than 18 years of age~   "
257102|NCT00185120|"~     A comparison of 2 different combinations of high blood pressure medications to treat~     hypertension~   "
257103|NCT00185107|"~     Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol~   "
257104|NCT00185094|"~     To examine the effect of three different blood pressure medications on the insulin~     sensitivity in overweight patients with high blood pressure.~   "
257105|NCT00185081|"~     The purpose of this study is to test the safety of the peptide and antibody and at the same~     time evaluate the tumor imaging of a two step antibody technique in nuclear imaging.~   "
257106|NCT00185068|"~     Effect of increasing doses of olmesartan medoxomil and olmesartan~     medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension~   "
257107|NCT00185055|"~     To assess the effects of 3 blood pressure drugs, called angiotensin receptor blockers, on the~     blood pressure control systems in healthy subjects.~   "
257108|NCT00185042|"~     The purpose of this study is to learn if CS-505 is safe and effective for slowing down or~     possibly reversing the buildup of tissue, cells and fatty deposits (plaque) in the blood~     vessels of the heart (coronary artery atherosclerosis).~   "
257109|NCT00185029|"~     This proposal is targeted at all patients with prostate cancer who are candidates for either~     curative surgery or curative radiotherapy in whom lymph node staging is indicated. Recently,~     it has been shown, that in patients with PSA <10 ng/ml and Gleason score < 7 the risk of~     lymph node metastases is low. Therefore, unnecessary PLND and non-invasive imaging can be~     avoided safely in this group. PLND is nowadays performed only in patients with intermediate~     or high risk for nodal metastases. Thus the subgroup of patients targeted in this study~     consists of patients with prostate cancer with a PSA >10 ng/ml and Gleason score > 6.~        -  If the high sensitivity (90%) and negative predictive value (96%) of MRL can be~          validated in the 8 participating centres, in patients with a negative MRL invasive PLND~          may be avoided.~        -  In patients with a positive MRL with enlarged nodes (larger than 8 mm) histological~          diagnosis may be obtained by imaged guided biopsy, and thus also in these patients avoid~          PLND. A limitation of image guide biopsy, however, is the 30% false negative rate.~          [Barentsz, Oyen, Wolf]~        -  In patients with positive small nodes (smaller than 8 mm) the urologist may, focussed by~          the MRL findings of a positive node outside his “surgical field-of-view”, extend his~          dissection, and thus improve his accuracy.~        -  Based on the expected higher sensitivity of MRL this technique will completely replace~          CT-scanning.~   "
257110|NCT00185016|"~     The study tested a training to improve recognition of abused female patients in family~     practice.Effect measures of the training were: number of reported cases wherein the doctor~     suspected and discussed partner abuse and the number of non-obviuos reasons to suspect~     partner abuse.We assumed that following a training would improve the recognition of abused~     women.~      Secondary to this trial we explored gender differences of family doctors in discussing~     partner abuse and we interviewed women recently identified by their family doctor. Medical~     histories of recently identified abused women were studied to assess health problems and~     health-care utilisation.~   "
257111|NCT00185003|"~     Background: Activation of NO-synthase and vascular potassium (K) channels may play a role in~     the sepsis-induced attenuated sensitivity to norepinephrine. We examined whether various K~     channel blockers and NO-synthase inhibition could restore norepinephrine sensitivity during~     experimental human endotoxemia.~   "
257112|NCT00184990|"~     Sepsis or endotoxemia is manifested by hypotension, resistance to vasopressors, myocardial~     depression,and altered organ blood flow distribution. The mechanisms underlying the~     cardiovascular dysfunction during sepsis are complex; however, they are partially mediated by~     an uncontrolled production of NO by inducible NO synthase (iNOS).Control subjects received 2~     ng/kg E. coli endotoxin, whereas the active intervention group received endotoxin in the~     presence of selective iNOS-inhibitor aminoguanidine. Hemodynamics, vascular responses to~     norepinephrine, acetylcholine and sodium nitroprusside, as well as circulating cytokines and~     other mediators of inflammation were measured. We tested the hypothesis that inhibition of~     NO-synthesis prevented the LPS-mediated insensitivity to noradrenalin and~     endothelial-dependent vasorelaxation. Furthermore, we tested whether NO participates in~     occurrence of the endotoxin tolerance in humans by using the iNOS inhibitor aminoguanidine on~     healthy volunteers with endotoxemia. At 0; 2 and 4 hours after the LPS challenge whole blood~     was stimulated with five TLR agonists in vitro and pro- and anti-inflammatory cytokines were~     measured.~   "
257113|NCT00184977|"~     The aim of this family practice based study is to determine the long-term treatment effects~     of two drugs that are presumed to modify the course and progression of chronic obstructive~     pulmonary disease (COPD), oral N-acetylcysteine and inhaled corticosteroids.~   "
257211|NCT00183690|"~     This study will compare the effectiveness of prolonged exposure therapy versus active~     psychotherapy in treating post-traumatic stress disorder (PTSD) in adolescents.~   "
257114|NCT00184964|"~     CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better~     than the CT-scan in patients with non-small cell lung cancer who also have atelectasis.~      This however has never been validated on a histological level. In this study patients with~     non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and~     a PET-scan prior to surgery.~      The resection specimen will be compared to the preoperative imaging.~   "
257115|NCT00184951|"~     open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with~     hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.~   "
257116|NCT00184938|"~     The most powerful protective mechanism against ischemia-reperfusion injury other than rapid~     reperfusion is ischemic preconditioning. Ischemic preconditioning is defined as the~     development of tolerance to ischemia-reperfusion injury by a previous short bout of ischemia~     resulting in a marked reduction in infarct size. This mechanism can be mimicked by several~     pharmacological substances such as adenosine and morphine.~      We, the researchers at Radboud University Nijmegen Medical Centre, have recently developed a~     method in which we can detect ischemia-reperfusion injury in the human forearm by using~     Annexin A5 scintigraphy (Rongen et al). With this method we will determine whether opioid~     receptors are involved in ischemic preconditioning. We expect to find that morphine can mimic~     ischemic preconditioning and that acute ischemic preconditioning can be blocked with the~     opioid receptor antagonist naloxon. This study will increase our knowledge about the~     mechanism of ischemic preconditioning and may also provide leads to exploit this endogenous~     protective mechanism in a clinical setting.~   "
257117|NCT00184925|"~     The purpose of this study is to investigate the incidence of ventilator associated pneumonia~     and late complications by comparing two different cannulas and two different percutaneous~     tracheostomy techniques.~   "
257118|NCT00184912|"~     Ischaemic preconditioning (IP) describes the phenomenon that brief periods of ischaemia~     render the (myocardial) muscle more resistant to a subsequent more prolonged period of~     ischaemia and reperfusion. Animal studies have provided evidence that adenosine receptor~     stimulation is an important mediator of IP. As caffeine is an effective adenosine receptor~     antagonist already at concentrations reached after regular coffee consumption, we aimed to~     assess whether caffeine impairs IP in humans in vivo. We used a novel and well-validated~     model to study IP in humans: 99m-Tc-annexin A5 scintigraphy in forearm skeletal muscle.~      24 healthy volunteers were randomly assigned to either caffeine (4 mg/kg/iv in 10 minutes) or~     saline before a protocol for IP.~   "
257119|NCT00184899|"~     The metabolic syndrome is associated with hyperdynamic circulation and sympathetic~     activation. Recently, Bakker et al. (Atherosclerosis 2002) described the hypothesis that free~     fatty acids are responsible for this association. The investigators hypothesize that in~     patients with obesity and the metabolic syndrome, an increased intracellular concentration of~     long-chain fatty acyl (LCFA)-CoA (the intracellular equivalent of free fatty acids) induces~     an increase in adenosine. Adenosine receptor stimulation, in turn, induces vasodilation and~     sympathetic activation.~      The investigators aimed to assess this effect of free fatty acids on the adenosine system in~     healthy volunteers.~   "
257120|NCT00184886|"~     In this study we aim to determine whether methotrexate influences the metabolism and vascular~     effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with~     potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation,~     ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have~     provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by~     adenosine receptor stimulation. In this study, we aim to determine whether also in humans in~     vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory~     arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after~     treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial~     artery is assessed as biomarker for the endogenous adenosine concentration.~      Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn~     homocysteine.~   "
257121|NCT00184873|"~     Leg ulcers are often chronic or recurring complications of peripheral circulation disorders.~     Patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in~     general. Especially exercise and compliance with compression therapy are key elements in the~     course of leg ulcer healing and recurrence. Yet many patients demonstrate sedentary~     lifestyles and non-compliance and current practice offers no systematic approach in the~     promotion of compliance and physical activity in these patients.~      The purpose of the study is testing 'Lively Legs' a compliance promotion program for patients~     with leg ulcers. The study tests the program on effects regarding:~        -  compliance with compression therapy and exercise levels~        -  time to leg ulcer recurrence~        -  cost effectiveness from a social perspective.~   "
257122|NCT00184860|"~     Technical developments in radiation oncology are making it possible to deliver a prescribed~     radiation dose to radiation target volume with increasing accuracy.~      Therefore it is becoming even more relevant to accurately define the radiation target~     volumes.~      The current standard in defining radiation target volumes in patients with head-and-neck~     cancer is to combine physical examination data with a CT-scan in the treatment position.~      The goal of this investigation is to analyse the rol of CT-PET-MRI image fusion in defining~     radiation target volumes.~   "
257136|NCT00184665|"~     This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this~     research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of~     insulin detemir compared to NPH insulin administered as basal insulin for the treatment of~     type 1 diabetes and to verify the safety of use (number and severity of episodes of~     hypoglycemia, body weight, and insulin antibodies and side effects).~   "
257137|NCT00184652|"~     This trial is conducted in Asia, Europe, and Middle East. Adult patients with chronic kidney~     disease are treated with growth hormone to assess effect on nutritional status.~   "
257138|NCT00184639|"~     This trial is conducted in Europe.~      A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in~     children between 6 and 21 years with type 1 diabetes.~   "
257139|NCT00184626|"~     This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of~     Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in~     combination with metformin in subjects with Type 2 Diabetes.~   "
257123|NCT00184847|"~     Ischemic preconditioning is defined as the development of tolerance to ischemia-reperfusion~     injury by a previous short bout of ischemia resulting in a marked reduction in infarct size.~     This mechanism can be mimicked by several pharmacological substances such as acetylcholine~     and adenosine.~      To detect ischemia-reperfusion injury in humans in vivo Kharbanda et al. developed a method~     in which endothelial dysfunction represents the effects of ischemic preconditioning. This~     method, however, uses acetylcholine to measure endothelial function before and after forearm~     ischemia. We, the investigators at Radboud University, hypothesize that the use of~     acetylcholine in this model reduces ischemia-reperfusion injury. Therefore, we will compare~     this protocol with a protocol in which endothelial function is only measured after ischemia.~     We expect an increase in ischemia-reperfusion injury when endothelial function is only~     measured after the forearm ischemia.~      After determining the optimal method to measure ischemia-reperfusion injury of the vascular~     endothelium we will determine the effect of acute and chronic caffeine, an adenosine receptor~     antagonist, on ischemic preconditioning. With this study we expect to find that adenosine~     mimics ischemic preconditioning of the vascular endothelium. Moreover, we expect to find that~     acute caffeine intake reduces ischemia-reperfusion injury whereas chronic caffeine intake~     does not. This study will increase our knowledge about the mechanism of ischemic~     preconditioning and may also provide leads to exploit this endogenous protective mechanism in~     a clinical setting.~   "
257124|NCT00184834|"~     An increasing aggressiveness in the surgical approach of colorectal liver metastases is~     observed. This seems only justified when, besides prolongation of survival, also the health~     status of patients is considered. The aim of this prospective study is to investigate the~     impact of surgery on health-related quality of life in this specific patient population~     operated for colorectal liver metastases.Furthermore, as the indications for hepatic~     resection are broadened and patients with more extensive liver disease are operated on, the~     chance of non operable disease at laparotomy will increase. The effects of such an event on~     HRQol are also studied.~   "
257125|NCT00184821|"~     In this proof-of-concept study, forearm vulnerability to ischemic exercise is studied in~     patients with type 1 diabetes mellitus with and without prior ischemic preconditioning (short~     period of ischemia that protects against subsequent ischemic exercise). Annexin A5~     scintigraphy is used to quantify subtle signs of mild and reversible forearm injury that~     results from ischemic exercise.~      The following hypotheses are tested:~        1. Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared~          with previously studied healthy volunteers.~        2. Ischemic preconidtioning is still present in patients with type 1 diabetes. Depending on~          the validity of hypothesis 2, the effect of short pharmacological interventions are~          studied on vulnerability to forearm ischemia/reperfusion injury in the absence or~          presence of local forearm ischemic preconditioning.~   "
257126|NCT00184808|"~     Patients with Parkinson's disease (PD) suffer from motor fluctuations and levodopa induced~     dyskinesia. The prupose of this study is to evaluate the effect of an automatic system to~     assess the motor state of PD patients in real daily life. Movements and postures are assessed~     using 6 accelerometers attached to the the most affected wrist, trunk, both upper legs and~     both upper arms. Patients wear the system for two days and keep an own diary of their motor~     state~   "
257127|NCT00184795|"~     This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes~     have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone~     replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and~     safety of different hormonal combinations will be evaluated and compared to placebo over the~     six month treatment period.~   "
257128|NCT00184782|"~     The purpose of this study is to evaluate the effect of primary tumor resection on the~     metabolic activity of metastases in patients with a colorectal primary tumor and synchronous~     liver metastases by positron emission tomography (PET) with 2-deoxy-2-fluoro[18F]-D-glucose~     (FDG-PET) scanning.~   "
257129|NCT00184769|"~     This trial is conducted in Europe. Objective(s): To evaluate the effect of human growth~     hormone on infants aged 1 to 2 years with chronic renal insufficiency (CRI) and growth~     retardation despite an adequate dietary intake.~      Trial Design: This is an open, parallel group clinical trial with a duration of one year, in~     which period 50% of patients will receive GH treatment and the other 50% will act as a~     control group, without treatment.~      Trial Population: The trial will involve a total of 16 infants aged from 12±3 to 24 months~     suffering chronic renal insufficiency (Glomerular Filtration Rate less than 60 ml/min/1.73~     m2), and growth failure and undergoing conservative treatment or peritoneal dialysis. Include~     the key inclusion and exclusion criteria.~   "
257130|NCT00184756|"~     This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial~     compares a treated group of patients with an untreated group of patients.~   "
257131|NCT00184743|"~     This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change~     in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth~     Hormone Deficiency, comparing two different treatment regiments.~   "
257132|NCT00184730|"~     This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to~     subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519)~     until hGH products have been approved for GHDA in Japan.~   "
257133|NCT00184717|"~     This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety~     of somatropin in children born small for gestational age (SGA) in Japan.~      In the main period, subjects will receive either active treatment for 104 weeks (two dosing~     regimens) or no treatment for 52 weeks followed by an extension period where subjects who~     received active treatment for 104 weeks (two years) will continue with the same treatment for~     further 156 weeks (three years) while those subjects who received no treatment for 52 weeks~     (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In~     total, subjects participate in trial for 260 weeks (five years).~      Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension~     period is registered as GHLIQUID-1517.~   "
257134|NCT00184691|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and~     tolerance of a new growth hormone (GH) formulation, in the treatment of children born with~     retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be~     multicenter, open label, parallel, randomized, Phase IIIb, controlled.~   "
257141|NCT00184600|"~     This trial is conducted in Europe.~      The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood~     glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added~     to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to~     verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and~     side effects).~   "
257142|NCT00184587|"~     The purpose of this study is to determine whether candesartan cilexetil are effective~     prophylactic treatment of episodic Cluster headache~   "
257143|NCT00184574|"~     This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic~     control in subjects with type 2 diabetes of three different premixed insulin analogues given~     in combination with an oral anti-diabetic drug.~   "
257144|NCT00184561|"~     This trial is conducted in Asia. This is a clinical trial investigating the effectiveness of~     using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in~     subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug~     therapy.~   "
257145|NCT00184548|"~     This trial is conducted globally. The purpose of the trial is to evaluate that activated~     recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely~     injured trauma patients by assessing mortality and morbidity.~      Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.~   "
257146|NCT00184535|"~     Delayed anticipatory muscle activity response in deep low back and abdominal muscles has been~     observed in patients with low back pain, indicative of a pathological condition. Muscle~     activity onset is traditionally recorded by intramuscular electromyography, but there is a~     need for a less cumbersome recording method in large clinical studies. The purpose of this~     experimental study is to explore whether high-frame rate m-mode ultrasound and tissue~     velocity imaging could measure anticipatory muscle responses (onset) in the abdominal~     muscles reliably and comparably accurate to intramuscular EMG.~   "
257147|NCT00184522|"~     A comparison of the effect of on demand treatment with a pectin-containing natural product~     (Aflurax) with that esomeprazole (Nexium)~   "
257148|NCT00184509|"~     The purpose of this study was to determine whether outreach integrated treatment of first~     episode schizophrenia was more effecive than standard outpatient treatment.~   "
257149|NCT00184496|"~     Cancer patients on morphine for chronic pain, with side effects or unsatisfactory pain~     relief, will be rotated to Methadone. We will try to find out what is the best methode to~     rotate, and the equivalent dosage.~   "
257150|NCT00184483|"~     Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation~     or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total~     number of 4 clinical examinations. End point is postoperative pain and recurrences.~   "
257151|NCT00184470|"~     St. Olavs Hospital is a trauma referral center in the region of Midtnorge. Admitting trauma~     patients locally and those referred from hospitals in Nord-Trøndelag, Sør-Trøndelag and~     Møre-Romsdal.An active trauma team was defined in 1992, but it`s work has not been evaluated~     earlier. Prospective studies of these patients were established 1st of January 2004 at St.~     Olavs Hospital.~   "
257152|NCT00184457|"~     Maximal strength training has been shown to increase muscular strength, muscular volume and~     work economy. An 8 week maximal leg press training regime will be conducted on cardiac heart~     failure patients to evaluate whether they increase their maximal leg press strength, work~     economy, serum testosterone and quality of life. The study hypotheses are that:~        1. Aerobic work capacity will increase due to increased work economy, without increases in~          maximal oxygen uptake.~        2. Strength training will increase serum testosterone.~   "
257153|NCT00184444|"~     The study investigates whether endurance training breathing 100% oxygen gives a additional~     improvement of maximal oxygen uptake in stable Angina Pectoris patients, compared to training~     without extra oxygen supplementation. In addition work economy, stroke volume and cardiac~     perfusion is measured.~      The hypothesis of the study is that increased oxygenation of the air increases performance,~     stroke volume, work economy and cardiac perfusion.~   "
257154|NCT00184431|"~     The aim of this study is to investigate whether additional task specific physiotherapy~     treatment and a self administrated home training program results in better balance compared~     to traditional follow up care.~   "
257155|NCT00184418|"~     The study is based on a hypothesis that there is interaction between the activity in the~     immune system and in the mind. To study this, the investigators register different measures~     for activity in the immune system on patients unselectedly admitted to an acute psychiatric~     ward. The psychiatric statuses and diagnoses of these patients are carefully defined as well.~   "
257156|NCT00184405|"~     This is a study evaluating changes in quality of life and global functioning across and after~     a manualized peer-group preventive intervention for children of parents with psychiatric or~     addictive problems.~   "
257157|NCT00184392|"~     The goal of this study is to increase knowledge about how to treat patients after sinus~     surgery.~   "
257158|NCT00184379|"~     The purpose of this study is to determine the effects of psychoeducation for relatives to~     patients with serious mental illness.~   "
257159|NCT00184366|"~     The main objectives of the project are:~        -  To classify patients suffering from plaque psoriasis responding on a given treatment~          (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis~          Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI)~        -  To characterize patients suffering from plaque psoriasis responding to or not responding~          to subcutaneous administrated efalizumab.~   "
257160|NCT00184353|"~     Increasing magnetic field is known to give improvements in signal-to-noise-ratio (SNR) and~     spectral resolution. To investigate this, spectra from different subjects were examined using~     two clinical MR instruments operating at 1.5T and 3T respectively.~   "
257161|NCT00184340|"~     This is the second phase (Phase B) of the main project Bank for Thoughts, which has the~     following aims:~        1. Improvement of software for secured (encrypted and access-controlled) asynchronous~          text-based communication within health services. (Adjustments for use in psychiatry.)~        2. Open clinical trials with Internet-mediated psychotherapy or counselling in out-patient~          child and adolescent psychiatry.~        3. Development of indications and precautions for text-based Internet-mediated~          psychotherapy.~   "
257162|NCT00184327|"~     Children receiving IFT (intensive family therapy) were assessed for symptom profile and~     global functioning before admission, 3 months after discharge and 1 year after discharge.~     Children were assessed by parents, children, their teachers and themselves. Parents were~     assessed by themselves at the same points in time through psychological self-report~     questionnaires.~      The study is intended to explore covariates to change in children as well as in parents~     during (pre-treatment) the treatment and follow-up periods.~   "
257163|NCT00184314|"~     Retrospective follow-up study of former eating disorder patients in child- and adolescent~     psychiatry on psychiatric symptoms and social intelligence.~   "
257164|NCT00184301|"~     The aim of this study is to determine whether in-patient treatment is better then intensive~     out-patient group treatment for patients with concurrent eating disorder and personality~     disorder.~   "
257165|NCT00184288|"~     The aim of the study is to investigate the feasibility of in vivo single volume MR~     spectroscopy in evaluation of treatment response in patients with brain metastases, using 3T~     MR instrument. In order to optimize and avoid ineffective treatment of patients with brain~     metastases, in vivo MR spectroscopy can be an useful tool.~   "
257166|NCT00184275|"~     The purpose is to characterize tumour biological markers in brain metastases tissue from~     patients with different primary tumour by using ex vivo techniques as high-resolution magic~     angle spinning MR spectroscopy and micro array.~   "
257167|NCT00184262|"~     The aim of the study is to determine whether exposure and response prevention (ERP) is more~     effective when patients are presented with a behavioral therapy versus cognitive therapy~     rationale in the treatment of obsessive-compulsive disorder (OCD).~   "
257168|NCT00184249|"~     The study is a prospective multi-centre study to investigate the effect of a new bipolar~     ablation strategy of the left atrium in patients with paroxysmal or permanent atrial~     fibrillation over time.~   "
257169|NCT00184236|"~     The aim of the present study was to determine the effects of either a multidisciplinary~     approach or intensity-controlled interval training on cardiovascular risk factors in~     overweight adolescents.~   "
257170|NCT00184223|"~     The purpose for this study is to determine whether 2x45 minutes Motivational Interviewing~     given during hospital stay to acutely admitted psychiatric patients with substance use~     problems, can reduce substance use after discharge.~   "
257171|NCT00184210|"~     Breast cancer tissue is collected from women undergoing scheduled surgery for breast cancer.~     The tissue specimen are analyzed by MR spectroscopy. After MR, the intact tissue specimen can~     be analyzed by other methods, such as histopathology.~      The MR spectral profiles are compared to clinical findings such as the patients diagnosis,~     lymph node status and tumor size.~   "
257172|NCT00184197|"~     The purpose of this study is to investigate the effect and side-effects of injections with~     botulinum toxin in neck muscles in cervicogenic headache compared to injections with sodium~     water.~   "
257173|NCT00184184|"~     This is a study of the registration of tobacco, coffee and substance abuse among acutely~     admitted psychiatric patients.~   "
257174|NCT00184171|"~     The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic~     colitis~   "
257175|NCT00184158|"~     The researchers want to find out the best treatment for cubital tunnel. The researchers~     establish the degree of nerve compression and then the patients are randomised to different~     treatment alternatives, ranging from conservative to operative treatments.~      The study is performed at 5 different hospitals in Norway.~   "
257176|NCT00184145|"~     The purpose for this study is to determine whether EMDR is effective in the treatment of~     specific (animal) phobia.~   "
257177|NCT00184132|"~     The purpose of the study is to compare effects of treatment of patients acutely admitted to a~     Psychiatric Intensive Care Unit (PICU) with either a sparsely decorated interior or interior~     decorations like an ordinary, Norwegian home.~   "
257178|NCT00184119|"~     The purpose of the study is to compare the effects of using or not using a Psychiatric~     Intensive Care Unit (PICU) in an acute psychiatric department.~   "
257179|NCT00184106|"~     We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their~     combination, (2) investigate the patterns of change and the mechanisms of action involved~     during treatment by using psycho-physiological assessments in order to delineate some of the~     cognitive, behavioural and physiological mechanisms in the patients' response to CT, to~     paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be~     selected and randomised into four treatment conditions. The first group (N=25) will be~     treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group~     (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo~     and clinical management (N=25). All patients will have 12 weeks of treatment in the acute~     phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd~     and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The~     4th group will have placebo for 24 weeks and clinical management. The patients will be~     assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12~     weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months.~      Measures are based on all three main sources; self-report inventories, clinical assessments~     by independent raters and psycho-physiological assessments.~   "
257180|NCT00184093|"~     The purpose of this study is first to establish what is the ideal dose of gemcitabine, a~     chemotherapy agent, when given in combination with radiation. In addition, the investigators~     want to determine the side effects and the effectiveness of this combination. The~     investigators will also study several markers to try to identify markers or tests that will~     predict which patients will benefit more from this treatment.~   "
257181|NCT00184080|"~     The purpose of this study is to evaluate the safety of an experimental drug called~     Elsamitrucin in people with non-Hodgkin's lymphoma and to see if it can shrink their tumors.~     Elsamitrucin has not been approved by the Food and Drug Administration (FDA). However, the~     FDA is permitting the use of this drug for this study.~   "
257212|NCT00183677|"~     This study will evaluate changes in brain energy metabolism due to treatment with~     escitalopram in people with major depressive disorder.~   "
257213|NCT00183651|"~     This study is a component analysis of dialectical behavior therapy (DBT) to determine the~     importance of DBT skills training and DBT individual therapy in treating suicidal women with~     borderline personality disorder.~   "
257182|NCT00184067|"~     This is a study of a melanoma vaccine. Study participants will have melanoma that invaded~     deeply and spread to lymph nodes or another location. Although the participants' melanoma has~     been removed, there is a greater than 1 out of 2 chance it will return. There will be~     approximately 40 subjects in this study. The patients will have already taken part in a~     melanoma vaccine study, and in this current study, they will continue to receive booster~     injections of a similar vaccine given for two additional years.~      This study will test an experimental vaccine. The vaccine contains peptides which are~     fragments of substances made by most melanomas. The substances are tyrosinase, gpl00 and~     melanoma antigen recognized by T cells (MART-1). The vaccine also includes an assistant~     called Montanide ISA 51. The assistant stimulates the immune system. This study will also~     test the effects of a second assistant granulocyte-macrophage colony-stimulating factor~     (GM-CSF). All participants will receive the vaccine and assistant Montanide ISA 51, but only~     half will receive the assistant GM-CSF. The patients have a one in two chance of receiving~     the assistant called GM-CSF. The main purpose of this study is to find out if the booster~     injections increase the body's immunity to melanoma and prevent its level of immunity from~     getting lower over time. The investigators also wish to know if the GM-CSF increases the~     body's immunity to melanoma when given with the melanoma vaccine.~      The vaccine and assistant Montanide ISA 51 are not approved by the Food and Drug~     Administration (FDA). The assistant GM-CSF is approved by the FDA to increase~     infection-fighting white blood cells after chemotherapy. It is not approved by the FDA for~     treatment of melanoma. However, the FDA is permitting the vaccine and the assistants to be~     tested in this study.~   "
257183|NCT00184054|"~     This clinical research study is for patients with acute myelogenous leukemia (in short AML)~     that did not respond to previous treatment or unable to receive chemotherapy.~      Arsenic has been used as a drug for many centuries. While arsenic containing drugs were used~     in the past for cancer treatments, the major use of arsenic in western countries has been for~     the treatment of uncommon tropical illnesses, such as sleeping sickness. Recently, some new~     information suggests that arsenic in a form called arsenic trioxide may also be useful to~     treat some cancers of the blood, such as leukemia, lymphoma and myeloma. Studies from China~     and the USA showed that patients with a type of blood cancer called acute promyelocytic~     leukemia, whose disease failed to respond to other treatments, responded very well to arsenic~     trioxide. Studies done in laboratories in the United States have shown that arsenic can kill~     AML cells growing in culture dishes.~      Ascorbic acid (vitamin C), a natural supplement in our diet, has long been involved with~     cancer prevention. Laboratory tests have shown that although arsenic trioxide by itself can~     kill AML cells in the test tube, when vitamin C is added to arsenic trioxide in a test tube,~     the death of the leukemia cells increases significantly.~      The purpose of this study is to find out if the combination of arsenic trioxide (Trisenox)~     and ascorbic acid is effective in the treatment of patients who have AML. The second purpose~     is to study how the two drugs affect cells in the laboratory. Samples from the blood and bone~     marrow (the part of the body that makes blood cells) will be collected, at specific times~     during treatment, in order to study them in the laboratory. By studying blood and marrow~     cells, researchers hope to learn the mechanisms by which the drugs work.~   "
257184|NCT00184041|"~     This study is for patients with recently diagnosed blood cancer, called acute lymphoblastic~     leukemia (ALL). The standard treatment for this disease consists of many chemotherapy drugs~     that are given in different combinations in several steps. Each step of treatment is called a~     cycle. Patients will be treated with the chemotherapy drugs that are routinely used in ALL~     and which are given in multiple treatment cycles over several months. All the chemotherapy~     drugs that are used in this study have been approved by the Food and Drug Administration~     (FDA).~      One of the drugs, which is typically given to patients with ALL, is called Asparaginase. It~     is given together with the other drugs throughout the different cycles of treatment. This~     drug can be derived from several sources. The standard source is called E. coli Asparaginase,~     which is associated with a risk of allergic reactions. This drug stays in the body for a very~     short period of time; therefore, it has to be injected daily for 9-14 days in a cycle of~     treatment.~      In this study, a different form of Asparaginase will be used, called PEG-Asparaginase (also~     called Oncospar), which remains in the body for about two weeks, therefore, it can be given~     only once in a cycle of treatment and still maintains high blood levels of the drug.~     PEG-Asparaginase has recently been approved by the FDA to treat ALL. Most of the experience~     with the drug has been in children with ALL. In children it was found to be as safe as the~     standard form of Asparaginase and with less allergic reaction. It was also found to have the~     same effectiveness on ALL. The experience with this drug in adults has been more limited.~      The purpose of the study is to find out what side effects occur in adults when~     PEG-Asparaginase is given with other chemotherapy drugs and to see what effect it has on the~     response to treatment of ALL. Another purpose is to find out if the allergic reactions are~     reduced with PEG-Asparaginase. In children there is some early information that~     PEG-Asparaginase produces fewer antibodies than E.coli Asparaginase. Therefore, another~     purpose of the study is to see how many adult patients who receive PEG-Asparaginase develop~     antibodies against the drug.~   "
257185|NCT00184028|"~     This research study is for subjects with squamous cell cancer of the head and neck which is~     not solely treatable with surgery or radiation. This research study involves treatment with~     an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of~     this study is to assess the effectiveness of this combination of medications for this type of~     cancer.~      Approximately 54 subjects will take part in this study.~   "
257186|NCT00184015|"~     This research study is for subjects with cancer of the kidney (also known as renal cell~     carcinoma) that cannot be treated with surgery. The purpose of this study is to see if the~     combination of bevacizumab and bortezomib is safe and tolerable and can help people with~     kidney cancer. The investigators would also like to find out what dose of the study drugs can~     be used safely and effectively, whether the combination of these two drugs can decrease~     cancer symptoms and stop tumor growth, and how frequently serious side effects might occur~     with this combination.~      The study will be conducted in two phases—Phase 1 and Phase 2. In Phase 1, subjects will be~     assigned to a fixed dose of bevacizumab and different strengths of bortezomib given at 2~     different schedules. Phase 2 will depend on how subjects tolerate the doses and schedules of~     bortezomib in Phase 1.~      Bortezomib is a type of drug known as a proteasome inhibitor. By blocking the proteasome~     in cancer cells, bortezomib affects the way these cells divide. Bevacizumab is an inhibitor~     (blocker) of blood vessel formation. Tumors need blood vessels in order to continue to grow~     and bevacizumab is thought to work by preventing new blood vessels from growing.~      Bortezomib (also called Velcade or PS-341) has been approved by the US Food and Drug~     Administration (FDA) for the treatment of myeloma, but has not been approved for the~     treatment of kidney cancer. Bevacizumab (also called Avastin) has been approved by the FDA~     for the treatment of colon cancer, but has not been approved for the treatment of kidney~     cancer. However, the FDA is permitting the combined use of bortezomib and bevacizumab in this~     research study.~      The bevacizumab that will be given in this study is not a commercially marketed product.~     Although it is expected to be very similar in safety and activity to the commercially~     available drug, it is possible that some differences may exist. Because this is not a~     commercially marketed drug, bevacizumab can only be administered to subjects enrolled in this~     study and may only be administered under the direction of physicians who are investigators in~     this study.~      Approximately 40-52 subjects will take part in this study.~   "
257207|NCT00183742|"~     This study is for patients with advanced cancer that has failed treatment with conventional~     therapy or for which no standard treatment exists. The purpose of this study is to determine~     the highest dose that can be given of 2 chemotherapy drugs, docetaxel (also called Taxotere)~     and liposomal doxorubicin (also called Doxil), when given together and to determine the side~     effects of this combination. Both Taxotere and Doxil are chemotherapy drugs that can decrease~     the size of several different tumors. Taxotere is approved by the Food and Drug~     Administration (FDA) for the treatment of breast and lung cancers, and Doxil is approved for~     the treatment of ovarian cancer.~   "
257187|NCT00184002|"~     The current standard treatment for non-Hodgkin's lymphoma involves drugs called~     cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called~     R-CHOP. Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of~     people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been~     reformulated and been placed in a fatty bubble called a liposome. The reason for placing the~     drug in the liposome is that there is evidence that the liposome is better taken up by~     tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or~     better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for~     ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By~     substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be~     better at shrinking tumors and with reduced side effects. The purpose of this study is to see~     how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone~     (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.~   "
257188|NCT00183989|"~     This study is being done in order to determine the effectiveness of the combination of~     fludarabine, mitoxantrone, and rituximab in patients with mantle cell lymphoma. All three~     drugs,fludarabine, mitoxantrone, and rituximab have been approved by the U.S. Food and Drug~     Administration (FDA)for the treatment of certain types of lymphoma. Rituximab is a drug~     (called a monoclonal antibody) which has anti-tumor activity on certain types of lymphoma.~     The combination of chemotherapy (fludarabine and mitoxantrone) with rituximab has not yet~     been investigated in patients with mantle cell lymphoma and therefore the combination in~     investigational.~   "
257189|NCT00183976|"~     This study is for patients who have been treated before and either the treatment did not work~     or the lymphoma has come back.~   "
257190|NCT00183963|"~     The subjects in this trial have been diagnosed as having a pre-cancerous disease of the~     breast called ductal carcinoma in situ (DCIS). This condition is associated with the~     development of breast cancer in up to 50% of cases.~      The subjects are being asked to participate in this research study. They are being offered~     voluntary admission to this study to test the effects of a new investigational drug called~     Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug~     Administration (FDA) for the treatment of advanced breast cancer but has not been approved~     for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in~     this study. The purpose of this study is to find out if Fulvestrant has any effect on the~     subject's precancerous changes by comparing samples taken before and after receiving~     Fulvestrant.~   "
257191|NCT00183950|"~     This study is for patients with non-hodgkin's lymphoma or chronic lymphocytic leukemia, which~     has failed to shrink or has returned after previous treatment with chemotherapy. The purpose~     of this study is to find out whether patients with these types of cancer will have their~     tumor shrunk after treatment with a drug called Noscapine. The second purpose is to see what~     are the side effects of this drug. This drug is being used as an over-the-counter cough~     suppressor in Europe and Japan, but has also shown to be effective against cancer.~   "
257192|NCT00183937|"~     This study is for patients who have been treated with surgical removal of the testes or~     hormone therapy (Lupron or Zoladex) and whose prostate cancer has worsened despite this~     treatment.~      PS 341 is a type of drug known as a proteasome inhibitor. By inhibiting the proteasome in~     cancer cells, PS-341 alters the way those cells divide). We hope to learn whether this~     combination chemotherapy decreases cancer symptoms and tests (prostate specific antigen, also~     called PSA), and to determine how frequently serious side effects might occur with this~     treatment for this stage of prostate cancer.~   "
257193|NCT00183924|"~     This study is for patients with prostate cancer that is metastatic, progressive, and~     resistant to hormonal manipulation and mitoxantrone chemotherapy.Patients have previously~     been treated with surgical removal of the testes or hormone therapy, and subsequently with~     chemotherapy that included the drug, mitoxantrone (Novantrone). Patients will have prostate~     cancer that has worsened despite these treatments.~      We hope to learn whether the combination chemotherapy decreases cancer symptoms and tests,~     and to determine how frequently serious side effects occur with acceptable toxicity from the~     chemotherapy.~   "
257194|NCT00183911|"~     The purpose of this study is to evaluate the side effects of a new treatment for stomach~     cancer which may potentially improve the prognosis of this cancer.~      Our principle objective is to improve the results of standard chemotherapy and radiation~     after surgery of patients with gastric cancer. The intra-abdominal (intraperitoneal)~     administration of floxuridine (FUDR) is a procedure that we have studied and have determined~     it is a safe treatment. In this study, we want to evaluate the side effects of this treatment~     when it is given after surgery but before standard intravenous chemotherapy and radiation.~      Study treatment will start with surgical removal of the part of the stomach with cancer,~     together with surrounding tissues and lymph nodes. After surgery, patients will get treatment~     with a chemotherapy drug, FUDR, administered directly into the abdomen. This is called~     intraperitoneal chemotherapy. After this treatment patients will receive repeated intravenous~     injection of two drugs, 5-fluorouracil and leucovorin alone or combined with irradiation of~     the abdomen.~   "
257195|NCT00183898|"~     This study is for people with advanced gastric or gastroesophageal cancer. This study is~     being done to find out how long it takes tumors to grow after patients take the drugs~     capecitabine, oxaliplatin and cetuximab. Capecitabine (also called Xeloda) is a drug that has~     been approved by the Food and Drug Administration (FDA). Capecitabine has been approved for~     treatment of cancer of the colon and rectum. Oxaliplatin is another drug approved by the FDA.~     Oxaliplatin is also approved for treatment of cancer of the colon and rectum. Cetuximab is~     also a drug approved by the FDA for the treatment of cancer of the colon and rectum, as well~     as cancer of the head and neck. Capecitabine, oxaliplatin and cetuximab are not approved for~     gastric or gastroesophageal cancer. They are considered experimental drugs for this study.~     The purpose of this study is to see how long it takes patients' tumors to progress when they~     are taking oxaliplatin and capecitabine. Another purpose is to see how many tumors respond to~     this drug combination. The investigators also want to see how long people live when taking~     these drugs. The side effects of this drug combination will also be evaluated. This study~     will also measure the levels of certain genes (the cell's blueprint) in tumors. These genes~     affect how peoples' bodies react to the cancer drugs. Genes will also be measured in the~     blood. The investigators want to see how these genes can predict response to these study~     drugs.~   "
257196|NCT00183885|"~     This study is for people with cancer of the liver that cannot be completely removed by~     surgery. This study involves giving the drugs mitomycin-C and cisplatin, into an artery in~     the liver. Mitomycin-C is a drug that has been approved by the FDA to treat cancer of the~     stomach and pancreas. Mitomycin-C is a drug that causes cancer cells to die and prevents them~     from reproducing. Cisplatin is also a drug that has been approved by the FDA. Cisplatin is~     approved to treat cancer of the testes, ovaries, lung, esophagus, bladder, head and neck.~     Cisplatin is a drug that prevents cancer cells from reproducing. The purpose of this study is~     to see how long it takes subjects' tumor(s) to grow after receiving the study drugs. Another~     purpose of this study is to look at the side effects of this study therapy and how long~     subjects survive after receiving it.~      An additional purpose of this study is to see how well we can predict subjects' response to~     the study therapy, based on blood and tumor tissue tests. These tests will measure the levels~     of genes (the cell's blueprint) in subjects' tumors and blood. These genes affect how~     people's bodies react to the cancer drugs.~   "
257197|NCT00183872|"~     This study is for people with advanced gastric or gastroesophageal cancer. This study is~     being done to find out how long it takes tumors to grow after receiving treatment with the~     drugs irinotecan (also known as CPT-11) and docetaxel (also known as Taxotere). Irinotecan is~     a drug that has been approved by the Food and Drug Administration (FDA). Irinotecan has been~     approved for treatment of cancer of the colon and rectum. Docetaxel is another drug approved~     by the FDA. Docetaxel is approved for treatment of breast, prostate and lung cancer. However,~     the FDA has authorized the use of irinotecan and docetaxel in this study. This study will~     evaluate the effects of these drugs on participant's tumors. The side effects of the~     combination of irinotecan and docetaxel will also be evaluated. This study will also measure~     the levels of certain substances in participant's tumors. These substances, called genes~     (which are the cell's blueprint), affect how people's bodies react to the cancer drugs. Genes~     will also be measured in participant's blood. The researchers want to see if these substances~     can predict response to the study drugs.~   "
257198|NCT00183859|"~     This is a research study for patients that have an advanced cancer that is confined mostly to~     the abdominal cavity and have failed treatment with conventional therapy, or for which no~     standard treatment exists. The purpose of this study is to determine the dose of a~     chemotherapy drug (called irinotecan) that can be administered safely into the abdominal~     cavity. We also wish to identify the side effects of irinotecan when it is administered~     directly into the abdomen. In this study, we will also determine the levels of irinotecan in~     the blood and in the abdominal cavity.~      Irinotecan is a chemotherapy drug that can decrease the size of several different tumors. It~     is approved by the FDA for the treatment of colon cancer. It appears that some other~     chemotherapy drugs are more effective and may have less side effects when they are~     administered directly into the abdomen.~   "
257199|NCT00183846|"~     This study is for people with advanced cancer of the digestive tract and cancer that cannot~     be completely removed by surgery. Radiation therapy is commonly used in the treatment of~     these types of cancer in combination with a chemotherapy drug, called 5-fluorouracil (5-FU).~     In this study, doctors will administer the standard dose of radiation therapy in combination~     with an investigational chemotherapy drug, called irinotecan. Irinotecan can decrease the~     size of tumors and also appears to increase the effectiveness of radiation. The purpose of~     this study is to determine the highest dose of irinotecan that can be given safely in~     combination with radiation therapy, and to determine the side effects when these two~     treatments are given together. Irinotecan is approved by the Food and Drug Administration~     (FDA) for the treatment of colon cancer, but is not approved for cancers of the digestive~     tract. However, the FDA is allowing its use in this research study.~   "
257200|NCT00183833|"~     This study is for people with solid tumors cancer for which the standard chemotherapy drugs~     have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also~     called capecitabine) in combination with a new anticancer agent called Gleevec (also called~     imatinib mesylate). Xeloda is an anticancer drug, and can be taken by mouth. The active~     ingredient is a well-studied cancer drug called 5-FU. Xeloda is approved by the FDA for the~     treatment of colon cancer. Gleevec is approved in the US for the treatment of patients with a~     leukemia called CML (increase of white blood cells) after failure of standard therapy. It is~     also approved by the FDA for patients with Gastrointestinal Stromal Tumors (a rare tumor in~     the digestive tract).~      This study will test how much Gleevec we can safely give with Xeloda. Xeloda will be given at~     the recommended dose for colorectal cancer and Gleevec will be given in increasing amounts.~   "
257201|NCT00183820|"~     This is a study for patients with advanced testicular cancer. This research study involves~     treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational~     chemotherapy combination. This study is for patients who have not responded to standard~     cisplatin-containing chemotherapy or the cancer has returned after such treatment.~      This research is being done to assess the effectiveness of the proposed combination of~     medications for this type of cancer.~   "
257202|NCT00183807|"~     This study is for patients with cancer of the esophagus. This study uses the drugs~     irinotecan, cisplatin and celecoxib. Irinotecan (also known as CPT-11) was recently approved~     by the U.S. Food and Drug Administration (FDA) for use in colon cancer, but has not been~     approved by the FDA for use in the treatment of cancers of the esophagus. Cisplatin is a drug~     that is commonly used to treat patients with cancer of the esophagus. We are combining these~     two chemotherapy drugs with a drug called Celebrex. Celebrex (also called Celecoxib) is an~     oral medication that is approved by the FDA for pain in the treatment of arthritis. There is~     some information to suggest that this drug may have anti-cancer activity. In prior studies~     combining irinotecan and cisplatin, tumors of the esophagus have been shown to shrink. We are~     adding Celebrex to these drugs to see if it makes the drugs work better to shrink cancer or~     cause fewer side effects.~   "
257203|NCT00183794|"~     This study is for patients with advanced ovarian cancer that has reappeared after treatment~     with conventional therapy. The purpose of this study is to determine if the combination of~     docetaxel and gemcitabine will be effective in reducing or eliminating the tumor(s) in~     patients with ovarian cancer.~      Docetaxel is approved by the Food and Drug Administration (FDA) for the treatment of breast~     and lung cancer; gemcitabine is approved by the FDA for the treatment of pancreatic and lung~     cancer. Neither docetaxel nor gemcitabine are approved for the treatment of ovarian cancer.~     Both drugs have been shown to decrease the size of ovarian cancer tumors.~   "
257215|NCT00183625|"~     This study will compare employment support with behavioral skills training to employment~     support alone in schizophrenia patients taking either risperidone or olanzapine to determine~     which is more effective in helping the patients maintain a job.~   "
257216|NCT00183612|"~     This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in~     children and adolescents with bipolar disorder or psychosis.~   "
257217|NCT00183599|"~     This study will compare four different combinations and durations of motivational enhancement~     therapy, cognitive behavioral therapy, and brief advice treatments for gambling versus a~     non-intervention condition to determine which is most effective in reducing problem gambling.~   "
257218|NCT00183586|"~     This study will compare specific family therapy, standard family systems therapy, and~     standard individual psychotherapy to determine which is most effective in treating adolescent~     anorexia nervosa.~   "
257219|NCT00183573|"~     This study will determine the effectiveness of a two-step HIV prevention program in reducing~     risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).~   "
257220|NCT00183560|"~     This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in~     preventing depression relapse.~   "
257221|NCT00183547|"~     This study will determine the effectiveness of the Living in Harmony depression prevention~     program in preventing depressive symptoms among pregnant American Indian adolescents during~     pregnancy and after giving birth.~   "
257222|NCT00183521|"~     This study will compare two different breathing regulation techniques to determine which is~     more effective in reducing the rate of panic attacks in people with panic disorder.~   "
257223|NCT00183508|"~     This study will develop a treatment for firefighters experiencing symptoms of acute stress~     disorder (ASD). Effective treatments may reduce immediate symptoms and prevent the~     development of more chronic conditions, such as post-traumatic stress disorder (PTSD).~   "
257224|NCT00183495|"~     This study will examine how various factors, such as psychiatric symptoms, gender, social~     support, substance use, and attitudes toward medication, affect treatment adherence in~     individuals with bipolar disorder.~   "
257225|NCT00183482|"~     This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus~     educational treatment in preventing depression in the children of parents with a history of~     depression.~   "
257226|NCT00183469|"~     This study will compare two different antidepressant treatment regimens to determine which is~     more effective in reducing symptoms of bipolar depression.~   "
257227|NCT00183456|"~     This study will determine the effectiveness of a peer outreach intervention in preventing HIV~     infection in adults at high risk for contracting HIV and other sexually transmitted diseases~     (STDs).~   "
257228|NCT00183443|"~     This study will determine the effectiveness of three different drug therapies in treating the~     symptoms of mania.~   "
257229|NCT00183430|"~     This study will evaluate the effectiveness of prazosin in treating post-traumatic stress~     disorder caused by noncombat trauma in individuals taking selective serotonin reuptake~     inhibitors.~   "
257230|NCT00183417|"~     This study will compare the effectiveness of two programs designed to prevent depression in~     adolescents.~   "
257231|NCT00183404|"~     This study will determine the short- and long-term safety and effectiveness of the drug~     olanzapine (Zyprexa®) for reducing symptoms of autism in children.~   "
257232|NCT00183391|"~     This study will determine the effectiveness of stimulant and nonstimulant medication in~     treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and~     adolescents.~   "
257233|NCT00183378|"~     This study will compare four different behavioral treatment programs to determine which is~     most effective in reducing night-time disturbances in individuals with Alzheimer's disease~     (AD).~   "
257234|NCT00183365|"~     This study will test the Protecting Families Program, a 10-week prevention program for~     depressed parents and their pre-teenage children, by comparing the effectiveness of the~     program versus parent training alone.~   "
257235|NCT00183352|"~     This study will determine the effect of medication for bipolar disorder on the reproductive~     function and whether mood changes occur during the menstrual cycle in women with bipolar~     disorder.~   "
257236|NCT00183339|"~     This study is a pilot study to evaluate the feasibility and safety of conducting a year long,~     double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance~     developmental processes in core areas impacted by autism.~   "
257237|NCT00183326|"~     This study will determine whether trauma-focused cognitive behavioral therapy (TF-CBT) is~     more effective than child-centered therapy (CCT) in reducing post traumatic stress disorder~     (PTSD) in children exposed to domestic violence (DV).~   "
257238|NCT00183313|"~     This study will determine the effectiveness of medical case management in improving the~     medical care of people with mental disorders or substance abuse problems.~   "
257239|NCT00183300|"~     This study will determine the effectiveness of immediate treatment with prolonged exposure~     therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of~     post-traumatic stress disorder in women.~   "
257240|NCT00183287|"~     The purpose of this study is to monitor the progression of HIV infection and HIV-related~     disease processes in patients who have previously participated in HIV clinical trials.~   "
257241|NCT00183274|"~     This study will assess the effectiveness of venlafaxine XR, randomized to either venlafaxine~     XR or placebo in preventing the relapse of generalized anxiety disorder after 6 months of~     treatment versus 12 months of treatment.~   "
257242|NCT00183261|"~     The purpose of this study is to determine whether the HIV vaccine MRKAd5 HIV-1 gag/pol/nef~     followed by treatment interruption can increase immune system function in adults with acute~     or recent HIV infection who have started taking anti-HIV drugs.~   "
257243|NCT00183248|"~     Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will~     evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system~     suppressing medications with or without infusions of bone marrow stem cells from the kidney~     donor. The purpose of this study is to find out which strategy is more effective in~     preventing organ rejection and maintaining patient health.~   "
259893|NCT00147979|"~     Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale:~     PTFE with or without bounded heparin~   "
257245|NCT00183222|"~     The purpose of this study is to determine whether naltrexone (an opiate blocking agent~     approved for the treatment of alcohol dependence), ondansetron a serotonin 3 antagonist~     medication approved to treat nausea) or their combination are effective in the reduction of~     alcohol craving and drinking compared to placebo.~   "
257246|NCT00183209|"~     The purpose of this study is to evaluate the efficacy of a 14-session behavioral intervention~     for HIV-infected and uninfected mothers with problem drinking. The intervention targets~     alcohol and drug problems, sexual risk behavior, and parenting. We hypothesize that mothers~     in the 14-session intervention condition will show improvements in alcohol and drug use,~     sexual risk behavior, and parenting in comparison to the control condition, which receives a~     one session brief video intervention.~   "
257247|NCT00183196|"~     The purpose of this study is to determine whether, after a period of abstinence, adding 6~     weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week~     naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence)~     treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone~     or placebo. All participants will receive alcohol counseling.~   "
257248|NCT00183183|"~     Alcohol abuse is associated with injury, chronic illness, absenteeism from work, and social~     costs to families and communities. The goal of this project is to translate motivational~     interventions successful in the primary care setting to the Emergency Department (ED)~     environment by implementing screening, brief intervention and referral to treatment (SBIRT)~     in order to reduce at-risk drinking among ED patients.~   "
257249|NCT00183170|"~     The primary goal of the study is to assess the residual effects of heavy drinking on academic~     performance. The investigators will also explore whether these effects differ by family~     history of alcohol abuse and hangover symptoms, as well as compare males and females with~     respect to these effects. The investigators' primary hypothesis is that intoxication (0.10g%~     blood alcohol concentration [BAC]) with an alcoholic beverage impairs next-day academic~     performance, as measured by scores on quizzes, standardized academic achievement tests, and~     standardized neurobehavioral assessments. Their secondary hypothesis is that~     family-history-positive individuals will show a greater performance decrement the day after~     heavy drinking than family-history-negative individuals.~   "
257250|NCT00183157|"~     The purpose of the study is to determine if a brief motivational interview in the context of~     an emergency health care visit will reduce high-risk drinking and drug-taking and associated~     health consequences among adolescents ages 14-21 years old.~   "
257251|NCT00183144|"~     The purpose of this study is to determine whether the Therapeutic Workplace is effective in~     increasing and maintaining long-term drug abstinence in homeless, alcohol dependent adults.~   "
257252|NCT00183131|"~     The objective of this project was to test the feasibility of electronic mail recruitment and~     web screening for hazardous drinking, to compare different approaches to encouraging~     screening, and to estimate the effects of minimal and more extensive feedback in preparation~     for a future alcohol web-based brief intervention study~   "
257253|NCT00183118|"~     The purpose of this study is to test an HIV prevention intervention in a Russian substance~     abuse treatment facility using a randomized trial study design.~   "
257254|NCT00183105|"~     The objective of this project was to test whether screening and brief intervention for~     unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption~     and linkage to alcohol assistance) and is cost-effective.~   "
257255|NCT00183092|"~     The purpose of this clinical trial is to determine the effectiveness of the medication~     quinacrine on survival in sporadic Creutzfeldt-Jakob disease (sCJD).~   "
257256|NCT00183079|"~     The purpose of this study is to determine whether a brief alcohol intervention reduces~     alcohol use and improves depression among depressed patients.~   "
257257|NCT00183066|"~     The purpose of this study is to collect bone marrow cells for research purposes.~   "
257258|NCT00183053|"~     The purpose of this study is to test an intervention to introduce and implement proximity~     alarms on the risk of falls in hospitalized patients.~   "
257259|NCT00183040|"~     The purpose of this study is to determine the relationship of deficiencies in testosterone~     and growth hormone to loss of muscle mass (sarcopenia) and functional impairment during aging~     and whether there is an interaction of these two hormone systems in maintaining normal~     skeletal muscle mass and physical function.~   "
257260|NCT00183027|"~     The purpose of this study is to develop an effective calorie restricted diet.~   "
257261|NCT00183014|"~     The purpose of this study is to examine the efficacy of a multifaceted behavioral~     intervention aimed at raising walking levels among sedentary older Latinos.~   "
257262|NCT00183001|"~     The purpose of this study is to determine if supplemental vitamin K will reduce age-related~     bone loss in elderly men and women above that achieved by supplementation.~   "
257263|NCT00182988|"~     The point of this research is to improve the communicative relationship between the caregiver~     and care receiver. It is input from the caregiver on these communicative behaviors that will~     inform the process of understanding how to reduce the caregiver burden that comes from this~     communicative relationship.~   "
257264|NCT00182975|"~     The purpose of this study is to determine whether bringing back the DHEA levels of older~     persons to the young range produces beneficial effects.~   "
257265|NCT00182962|"~     The purpose of this study is to test the effectiveness of a collaborative model of team care~     as compared to usual care in improving functional outcomes among community-dwelling~     low-income older adults.~   "
257279|NCT00182767|"~     This trial is studying the side effects and best dose of ixabepilone when given together with~     pegylated liposomal doxorubicin hydrochloride and to see how well they work in treating women~     with advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or~     metastatic breast cancer. Drugs used in chemotherapy, such as ixabepilone and pegylated~     liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells.~   "
257294|NCT00182559|"~     The aim of the study is to determine if the conversion from the immunosuppressive agent~     cyclosporine to tacrolimus contributes to an improvement of the cardiovascular risk factors,~     better kidney function and immune system.~   "
257266|NCT00182949|"~     Background:~      - The island of Sardinia, an Italian region, has a population that is highly interrelated.~     Researchers have developed the SardiNIA longitudinal study to examine the possible genetic~     factors that predispose individuals to diseases and to various inherited conditions. In the~     study, participants will be drawn from four towns in the Ogliastra region (Lanusei, Ilbono,~     Elini, and Arzana), and their DNA will be analyzed and compared with a long-term assessment~     of various health-related events. The SardiNIA study is designed to improve understanding of~     the genetic factors involved in age-associated diseases and disorders, and provide possible~     points of intervention that may help prevent diseases.~      Objectives:~      - To conduct a long-term study of genetics and epidemiology in a small and highly~     interrelated population.~      Eligibility:~      - Individuals at least 18 years of age (at least 14 years of age for Phase 1 of the study)~     who live in the province of Ogliastra in eastern Sardinia.~      Design:~        -  This 10-year study will involve three phases: collecting initial blood samples and~          medical history (years 1 to 4), and two sets of follow-up visits to collect additional~          data (3 years apart).~        -  Participants will provide detailed medical history and information for long-term study,~          primarily involving the following aspects:~        -  Demographic/family and clinical variables (e.g., medications, fertility,~          hospitalizations and surgical procedures, age of relatives who are still alive, age and~          cause of death in deceased relatives) (Phase 1)~        -  Complete physical examination, including measures of height and weight, blood pressure,~          and basic heart function (Phase 1)~        -  Blood and urine samples (Phase 1)~        -  Heart and lung function tests (Phase 1)~        -  Assessment of general personality traits and possible history of depression (Phase 1)~        -  Dietary assessment through a food frequency questionnaire (Phase 1)~        -  Cognitive tests of attention, memory, and concentration (Phases 1 and 2)~        -  Frailty-related tests (e.g., hand grip strength, walking speed, bone strength) (Phases 1~          and 2)~        -  Eye examination to test for evidence of disease or macular degeneration (Phases 1 and 2)~        -  Kidney and thyroid ultrasound (Phases 1, 2, and 3)~   "
257267|NCT00182936|"~     The purpose of this study is to develop a comprehensive Delirium Abatement Program of care of~     delirious patients in the post acute care setting and to evaluate its impact on persistence~     and severity of delirium and on functional recovery.~   "
257268|NCT00182923|"~     The purpose of this study is to learn the effect of inherited differences on forearm blood~     flow responses to hormones and drugs~   "
257269|NCT00182897|"~     The primary goal of the study is documentation of effectiveness of a home-based intervention~     to reduce caregiver burden related to dementia caregiving, improve caregiver health status,~     and reduce caregiver and care recipient resource utilization.~   "
257270|NCT00182884|"~     The purpose of this study is to explore the efficacy of a perioperative daily dose of~     Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.~   "
257271|NCT00182871|"~     The purpose of this study is to assess the effects of testosterone replacement on bone~     density, muscle strength, physical performance, quality of life and prostate symptoms in men~     selected for low bone mineral density or fracture and some aspect of frailty.~   "
257272|NCT00182858|"~     The need to obtain human tissue (blood, urine, saliva, sweat, pleural, pericardia\, ascitic,~     synovial, cerebrospinal fluids) for methods development and disease correlation is frequent~     in Gerontology Research Center laboratories. This protocol is to create the opportunity to~     obtain such tissue samples that have been obtained during the course of usual clinical care~     and would be discarded, or alternatively, to obtain such samples during subject and patient~     screening for other studies (in this case only blood, urine, saliva, or sweat). Information~     derived from such studies is for research purposes only and is not provided to the~     patient/subject or their health care provider. When genetic analyses are performed, samples~     will have been coded and identifying information linking patient/subject to the sample will~     be destroyed. Any genetic information obtained will have no established clinical value and~     will not be provided to the subject/patient or their health care provider.~      Patients included will be those 18 years or older and who have been identified by the~     investigator to have a condition of interest for exploratory studies related to the patient's~     illness or other feature that offers the possibility of creating information that leads to~     scientifically useful and important studies. Patients will be excluded if obtaining the~     sample would be over and above usual clinical care, would result in excessive blood loss, or~     the individual is unable to provide informed consent.~      The expected outcome is to provide the investigator the opportunity to obtain tissues of~     interest for laboratory evaluation with the goal of either better understanding a disease or~     to design a scientific study to better understand or treat a disease.~   "
257273|NCT00182845|"~     The purpose of this study is to evaluate the feasibility of using Donepezil to prevent~     post-operative cognitive decline (POCD) among individuals aged 65 and older who have a~     baseline mild cognitive impairment (MCI) and are undergoing elective hip or knee replacement.~   "
257274|NCT00182832|"~     The purpose of this study is to evaluate the effectiveness of a cognitive screening program~     coupled with a computerized decision support system in improving the quality of care for~     hospitalized older adults with cognitive impairment.~   "
257275|NCT00182819|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. It is not yet known whether~     radiation therapy is more effective than temozolomide in treating gliomas.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared to temozolomide in treating patients with gliomas.~   "
257276|NCT00182806|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan~     together with gemcitabine may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine~     works in treating patients with recurrent or progressive stage III or stage IV non-small cell~     lung cancer.~   "
257277|NCT00182793|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as trastuzumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. An autologous stem cell transplant may be able to replace~     blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab~     followed by an autologous stem cell transplant and radiation therapy may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or~     without trastuzumab followed by an autologous stem cell transplant and radiation therapy~     works in treating patients with stage III or stage IV breast cancer.~   "
258303|NCT00169039|"~     This study will examine the physical response to clozapine or chlorpromazine in people with~     schizophrenia that has not improved with treatment.~   "
257280|NCT00182754|"~     RATIONALE: Octreotide may be an effective treatment for malignant ascites. It is not yet~     known whether octreotide is more effective than a placebo in treating malignant ascites.~      PURPOSE: This randomized phase III trial is studying octreotide to see how well it works~     compared to placebo in treating patients with cancer-related malignant ascites.~   "
257281|NCT00182741|"~     RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to~     grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~      PURPOSE: This phase II trial is studying how well giving calcitriol together with~     mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.~   "
257282|NCT00182728|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     during surgery may be an effective treatment for breast cancer.~      PURPOSE: This phase II trial is studying how well radiation therapy works in treating older~     women who are undergoing surgery for invasive breast cancer.~   "
257283|NCT00182715|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. It is not yet known whether combination chemotherapy and cetuximab are more~     effective than combination chemotherapy alone in treating colorectal cancer.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab~     to see how well they work compared to combination chemotherapy alone as first-line therapy in~     treating patients with metastatic colorectal cancer.~   "
257284|NCT00182702|"~     This phase II trial is studying how well ixabepilone works in treating patients with~     metastatic, recurrent, or unresectable kidney cancer. Drugs used in chemotherapy, such as~     ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing~   "
257285|NCT00182689|"~     This phase II trial is studying how well sorafenib works in treating patients with extensive~     stage small cell lung cancer. Sorafenib may stop the growth of small cell lung cancer by~     blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.~   "
257286|NCT00182663|"~     This phase II trial studies the side effects and how well giving thalidomide, dexamethasone,~     and clarithromycin together works in treating patients with multiple myeloma previously~     treated with transplant. Biological therapies, such as thalidomide and clarithromycin, may~     stimulate the immune system in different ways and stop cancer cells from growing.~     Dexamethasone also works in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving thalidomide together with~     dexamethasone and clarithromycin after a transplant may be an effective treatment for~     multiple myeloma~   "
257287|NCT00182650|"~     RATIONALE: Cellular adoptive immunotherapy uses a person's white blood cells that are treated~     in the laboratory to stimulate the immune system in different ways and stop cancer cells from~     growing. Rituximab and fludarabine may also prevent the body from making an immune response~     against the laboratory-treated white blood cells that are put back into the body.~     Interleukin-2 may help the laboratory-treated white blood cells stay in the body longer.~     Giving cellular adoptive immunotherapy together with rituximab, fludarabine, and~     interleukin-2 may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy~     in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.~   "
257288|NCT00182637|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with~     relapsed or refractory cutaneous T-cell lymphoma.~   "
257289|NCT00182624|"~     This study will determine whether scanning the prostate using special magnetic resonance~     imaging (MRI) techniques can detect prostate cancers with greater accuracy than other~     methods. MRI uses a strong magnet and radio waves to produce images of body tissues. Unlike~     many cancers, prostate cancer is difficult to see on most imaging studies like x-rays,~     computed tomography (CT) scans, and conventional MRI scans. This study will use a magnet~     twice as strong as the magnets commonly used in MRI tests.~      Patients 18 years of age and older with prostate cancer confirmed by prostate biopsy may be~     eligible for this study. Candidates are screened with a medical history, physical~     examination, and review of pathology reports.~      Participants undergo MRI of the prostate and possibly a biopsy of the prostate gland, as~     follows:~      Prostate MRI~      Before coming to the NIH Clinical Center for the biopsy, patients take a Fleets enema to~     empty the rectum of fecal matter. For the MRI, an endorectal coil (a tube containing a~     specially designed antenna) is placed in the rectum, which is just behind the prostate. The~     coil increases the amount of signal received by the MRI unit. Additional coils may be wrapped~     around the pelvis to further improve the quality of the scan. The patient lies on a stretcher~     that moves into the scanner. A catheter (plastic tube) is placed in an arm vein for injection~     of a contrast agent called gadolinium, which brightens the images. Patients may also be asked~     to breathe an oxygen-rich gas through a mask during the scan to test the use of oxygen as a~     contrast agent in MRI. Patients may be asked to repeat the MRI to test the reproducibility of~     the procedure. The repeat test is optional.~      Prostate Biopsy~      Depending on the MRI findings, patients may be asked to undergo a prostate biopsy to obtain a~     sample of tumor tissue. The tissue is obtained with a needle placed through the rectum.~     Medicines may be used to reduce pain during the biopsy and to reduce the chance of infection.~   "
257290|NCT00182611|"~     RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Giving chemotherapy before surgery may shrink the tumor so that it can be removed. It is not~     yet known whether giving S-1 together with cisplatin before surgery is more effective than~     surgery followed by S-1 in treating stomach cancer.~      PURPOSE: This randomized phase III trial is studying how well giving S-1 together with~     cisplatin before surgery works compared to surgery followed by S-1 in treating patients with~     stage III stomach cancer.~   "
257291|NCT00182598|"~     The purpose of this clinical trial is to examine the efficacy and cost-effectiveness of an~     interactive, computer-based psychoeducational system when used by opioid-dependent patients~     in office-based buprenorphine treatment.~   "
257292|NCT00182585|"~     In this study, the investigators are developing and evaluating an interactive,~     computer-assisted HIV, STD and disease prevention program for young substance abusers that~     incorporates effective components of both prevention science and educational technologies.~   "
257293|NCT00182572|"~     The purpose of this study is to evaluate ways to optimize outcomes from combined~     behavioral-pharmacological treatment for opioid-dependent youth.~   "
257295|NCT00182546|"~     The main objective of the trial is to determine whether D-dimer testing combined with~     assessment of Pre-Test-Probability (using a standardized clinical model) can be used to~     markedly simplify the diagnostic process for PE.~      It may be safe to omit additional diagnostic testing in selected patients with suspected~     pulmonary embolism who have a negative D-dimer test~   "
257296|NCT00182533|"~     Selective serotonin reuptake inhibitors (SSRIs) including sertraline have been found to be~     effective in the treatment of generalized social phobia (GSP). However, virtually all of the~     current treatment studies with medicines, including the SSRIs, have excluded patients with~     social phobia who have other co-occurring conditions. In fact, 80% of individuals suffering~     with primary social phobia have at least one other anxiety. This study will evaluate the~     safety and efficacy of sertraline in the treatment of generalized social phobia with~     co-occurring anxiety and mood disorders.~   "
257297|NCT00182520|"~     SRI's are considered first-line treatments for OCD, however many patients continue to have~     significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown~     that the glutamate neurological system is involved in OCD. This study will test the safety~     and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where~     the OCD has been un-responsive, or partially responsive to regular SRI treatment.~   "
257298|NCT00182507|"~     Trichotillomania (TTM) or hair-pulling has been considered as part of the obsessive~     compulsive disorder (OCD) spectrum, although treatment with OCD medications has largely been~     unsuccessful. Tics/Tourrettes’ Syndrome (TS) is a disorder, which appears to be related to~     TTM, but is treated with a different class of medications than used in OCD, namely~     antipsychotics such as olanzapine. This is a study of the safety and efficacy of olanzapine~     in the treatment of hair pulling.~   "
257299|NCT00182494|"~     Diabetes is 2-5 times more common in schizophrenia and it is a preventable; but the current~     diabetes prevention guidelines are not suitable for implementation in the severely mentally~     ill population. The principles of diabetes prevention are essentially dietary regulation,~     increased physical activity and adjunctive use of oral anti-diabetic drugs (metformin). In a~     modified diabetes prevention protocol suitable for use in mentally ill population, we~     packaged the original guide lines with an adventure and recreation program based on~     principles of experiential learning, cognitive restructuring and behaviour modification. In~     this proposed study, we plan to evaluate the feasibility of adopting the new protocol, and~     examine its effectiveness in preventing diabetes.~   "
257300|NCT00182481|"~     The purpose of this study was to determine whether the use of induced sputum cell counts~     could guide treatment of asthma more effectively than the use of symptoms and breathing~     tests. The main outcomes where the time to the first exacerbation and the number of~     exacerbations.~   "
257301|NCT00182468|"~     The purpose of the research is to evaluate whether routine screening for woman abuse in~     health care settings, as compared to no screening, does more good than harm. Recent reviews~     have identified the need for high quality research to understand 1) the actual impact on all~     women of instituting mass screening procedures to identify woman abuse and 2) the extent to~     which early identification through screening is effective in preventing or ameliorating~     important outcomes. The main outcomes for the study are reduction in violence, improvement in~     life quality, and potential harms of screening. A number of secondary outcomes to help~     understand the process by which screening and usual care might lead to changes in the primary~     outcomes will also be assessed.~   "
257302|NCT00182455|"~     SSRI's are considered first-line treatments for GSP, however many patients continue to have~     significant symptoms despite an adequate trial of an SSRI. Topiramate, a drug, which targets~     the glutamate system in the brain, has been shown to improve symptoms of social phobia when~     used on its own and has also been used as an additive treatment in other anxiety disorders.~     This study will test the efficacy of adding topiramate to a subject's current SSRI in cases~     of GSP which are considered to be treatment-resistant.~   "
257303|NCT00182442|"~     People affected by schizophrenia often experience poor concentration, lapses in memory and~     difficulty with completing tasks; and this set of problems are known as neuro-cognitive~     deficits. Traditional medications used in the treatment of schizophrenia have not been~     particularly useful in improving these problems, while the recently introduced medications~     are expected to be superior in this respect. The proposed research study is designed to~     assess the effect of two of the new medications (Zyprexa and Seroquel) in improving the~     neurocognitive deficits associated with schizophrenia.~   "
257304|NCT00182429|"~     What is the difference between the use of one drug (Oral Metronidazole) versus the use of~     this same drug combined with another drug (Rifampin) in treatment of bacteria and~     infection-associated diarrhea in patients? This infection is an important cause of morbidity~     and mortality in both the community and hospitals, and the leading cause of hospital and~     chronic facility-acquired diarrhea. Research is important for the treatment of this~     infection. Patient care with use of two medication treatment regimens will be studied.~   "
257305|NCT00182416|"~     Pacemaker therapy has been recognized as effective for the control of sinus and~     atrio-ventricular (AV) node dysfunction. Single chamber pacing when compared with dual~     chamber pacing, has numerous advantages of low complication rates, lower cost, better~     longevity, with non-inferiority in the quality of life and hard outcomes proven in direct~     randomized comparisons. However, comparison between single and dual chamber pacers was never~     adequate, since not more then half of the patients in the trials were actually using~     pacemakers for the majority of the time. Routine dual chamber pacing using a right ventricle~     apical lead is also associated with significant increase in peri-operative and remote~     complications. Some of these complications may be related to ventricular desynchronization~     secondary to the pacing location, which is potentially avoidable by using biventricular~     pacing. A randomized trial which will compare single chamber rate responsive pacing to the~     best available modification of dual chamber pacing (biventricular pacing) in suitable~     patients is therefore warranted.~   "
257306|NCT00182403|"~     FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with~     fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during~     which they received warfarin (target INR 2.0-3.0).~   "
257318|NCT00182247|"~     To simplify and improve the diagnostic approach to patients with clinically suspected~     recurrent DVT by determining whether the results of the combination of IPG and d-dimer~     testing, using a whole blood agglutination assay, can be used in the management of such~     patients.~   "
257307|NCT00182390|"~     Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight~     (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined~     as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular~     leukomalacia/ventriculomegaly).~      Primary Objective: To determine whether either a liberal or more restrictive threshold of~     hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either~     a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.~      Follow-up at a corrected age of 18 months represents a conventional age at which to first~     assess neurodevelopmental outcomes, and to predict long-term outcomes.~   "
257308|NCT00182377|"~     Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid~     administration. Fluids are used routinely to replace blood lost during and after surgery.~     Significant amounts of fluid are also used to prime the tubing and components of the~     cardiopulmonary bypass pump before and during its use. The use of Pentaspan - a synthetic~     pentastarch - was started because of the restriction of use for blood and blood products,~     particularly albumin. Pentaspan is usually used after surgery in the Intensive Care Unit~     (ICU). The impact of the use of pentastarch on coagulation, fluid balance and bleeding are~     very limited. This study will methodically evaluate the impact of using increasingly greater~     amounts of pentastarch during surgery on an open heart surgery patient's recovery in~     particular - is there more bleeding, does his/her blood clot as well, and how much fluid~     overall is used and excreted?~   "
257309|NCT00182364|"~     PROTECT Pilot objective is to assess: 1) the feasibility of timely enrollment and complete,~     blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired~     renal insufficiency and its association with bleeding, 3) the feasibility of scheduled twice~     weekly lower limb ultrasounds, and 4) recruitment rates for a future randomized trial.~   "
257310|NCT00182351|"~     To determine whether d-dimer testing can be used to simplify and reduce the costs of the~     diagnostic approach to patients with clinically suspected deep vein thrombosis~   "
257311|NCT00182338|"~     Patients with kidney failure on dialysis have a much higher risk of developing cardiovascular~     disease as compared to the general population. Recently, two large studies have shown that~     increasing the amount of dialysis does not decrease cardiovascular disease. It is known that~     retaining too much fluid leads to high blood pressure and thickening of the heart wall.~     Peritoneal dialysis is a method of home dialysis which allows dialysis patients autonomy and~     independence. This study will measure blood levels of a protein called N-BNP and measure the~     extent of body fluid by a machine called a bioimpedance analyzer. This device administers an~     undetectible electric current which distributes throughout total body water. The relationship~     between these tests and the clinical presence of volume expansion will be assessed. In~     addition, the extent of total body fluid and it's impact on heart attacks, heart failure and~     stroke will be determined.~   "
257312|NCT00182325|"~     Many women are turning to the Internet to meet their health information needs, but the large~     amount of information available, as well as the unknown reliability and applicability of~     information can be overwhelming. Studies in specific patient populations have determined that~     patients given access to personalized, on-line medical information are more satisfied with~     their care than patients provided generalized information. None of these studies have looked~     at whether this type of patient education would be helpful for pregnant women. This study is~     being done to determine whether pregnant women who have access to their own health records~     and personalized health information over the Internet are more satisfied with their prenatal~     care, and if they are more compliant with health visits and tests, compared to pregnant women~     who receive only generic pregnancy information on the Internet and from pamphlets~   "
257313|NCT00182312|"~     At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams~     at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting~     disabilities. The aim of this research is to reduce this heavy burden of illness. A~     multi-center randomized controlled trial has been designed in which 2000 very low birth~     weight infants will be enrolled. Our goal is to determine whether the avoidance of~     methylxanthine drugs will improve survival without disability to 18 months, corrected for~     prematurity.~      Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and~     breath-holding spells in premature infants. However, there is a striking lack of evidence for~     the long-term efficacy and safety of this therapy. Methylxanthines block a naturally~     occurring substance, called adenosine, which protects the brain during episodes of oxygen~     deficiency. Such episodes are common in infants who are treated with methylxanthines. It is~     possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this~     trial will clarify whether methylxanthines cause more good than harm in very low birth weight~     infants.~   "
257314|NCT00182299|"~     The prognosis for patients with large rotator cuff tears is poor. This recently developed~     biologic scaffold provides numerous structural and functional properties that may direct cell~     growth and aid in tendon healing. To date, there are no randomized clinical trials assessing~     the effectiveness of the patch to augment repairs of large rotator cuff tears. We propose a~     study to compare the rate of repair failure, quality of life, function, pain, and range of~     motion in 60 patients with large rotator cuff. Patients will be randomized (like flipping a~     coin) to undergo a standard rotator cuff repair with or without augmentation with SIS.~     Patients are assessed at 6 weeks, 3, 6, 12, 18, and 24 months post-operative~   "
257315|NCT00182286|"~     This project was conducted with patients at a multi-disciplinary, multi-specialty health~     services organization serving 44,000 rostered patients in Northern Ontario. It investigated~     continuity of care for patients with diabetes in the areas of barriers and potential~     solutions to, and correlates of continuity; and variability in costs associated with~     continuity of care and patient outcomes.~   "
257316|NCT00182273|"~     The purpose of this study is to see whether family doctors can treat benign paroxysmal~     positional vertigo (BPPV), or dizziness, using a procedure in the office. The study is~     looking at whether the treatment procedure cures the dizziness in more patients compared to~     patients that receive a sham or placebo procedure.~   "
257317|NCT00182260|"~     LNF is an effective intervention in the management of patients with chronic GERD requiring~     maintenance therapy. LNF is cost-effective compared with long-term medical therapy.~      LNF is more effective than maximum medical therapy in control of respiratory symptoms and~     complications of GERD.~   "
257319|NCT00182234|"~     This research project will address the issue of gaps in continuity of supportive care for~     cancer patients during the early phases of the disease trajectory that result in unmet needs~     and unnecessary morbidity. The investigators intend to study the impact of a specialized~     cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes.~     Impact will be assessed directly using a validated measure of continuity of care from the~     patients' perspective and validated measures of key supportive care patient outcomes~     including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized~     trial.~   "
257320|NCT00182221|"~     To determine whether D-Dimer testing, using the MDA D-Dimer assay, can be used to simplify~     the diagnostic process for pulmonary embolism (PE). This will be assessed by performing a~     cohort study in 1000 patients with suspected PE.~      To ascertain if an MDA D-Dimer result of less than 0.75 ug/mL FEU obviates the need for~     further testing and therapy in patients with suspected PE.~   "
257321|NCT00182208|"~     The purpose of this study is to determine whether daily use of a lower limb venous-return~     assist device, Venowave', improves leg symptoms, ability to perform activities of daily~     living, and quality of life in subjects with severe PTS.~   "
257322|NCT00182195|"~     A multinational, randomized trial comparing two lung protecting strategies of respiratory~     life support among critically ill patients with severe lung injury.~   "
257323|NCT00182182|"~     Evaluation of a primary care based (family physicians) HF management strategy in patients~     with heart failure in the community~   "
257324|NCT00182169|"~     Prospective randomized, placebo controlled, clinical trial to evaluate the effect of human~     growth hormone supplementation compared with placebo to patients with severe heart failure~     for a duration of 6 months on exercise capacity, heart function and quality of life~   "
257325|NCT00182156|"~     This study is examining the effects of short daily hemodialysis on platelet function, fluid~     volume control, arterial stiffness and patient quality of life, as compared to conventional~     hemodialysis.~   "
257326|NCT00182143|"~     The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH)~     (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal~     leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary~     outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and~     objectively confirmed venous thrombosis at any site.~   "
257327|NCT00182130|"~     The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to~     positively influence surgeon practice can decrease hospital rates of permanent colostomy and~     local tumour recurrence for surgically treated rectal cancer patients.~   "
257328|NCT00182117|"~     This study is examining the risk and protective factors associated with bleeding in the~     hemodialysis population.~   "
257329|NCT00182104|"~     Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years~     following Fontan procedures.~   "
257330|NCT00182091|"~     The purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men~     and women with a history of acromegaly and who are now growth hormone deficient. We will~     compare them to persons with a history of acromegaly who have normal GH levels.~      Acromegaly results when an area in the brain, called the pituitary, produces too much growth~     hormone. When an individual is cured of acromegaly, the growth hormone levels may be normal~     or low (that is GH deficiency). Growth hormone deficiency means the body no longer produces~     as much growth hormone because the pituitary/hypothalamic region was damaged by a tumor or by~     treatment received.~      We will study the effects of growth hormone replacement on the health of the heart and blood~     vessels of GH deficient persons by looking to see if this therapy:~        1. has effects on cardiovascular risk markers (special blood tests which indicate how~          healthy your heart and arteries are)~        2. affects the stiffness of the arteries~        3. affects your heart rate and the capacity of your heart to respond to changes in body~          position~        4. has different effects depending on whether you are taking estrogen / testosterone.~      We will assess these measures of health on one occasion in persons with cured acromegaly and~     normal GH levels and in persons with cured acromegaly who have GH deficiency and a~     contraindication to receiving GH. GH deficient individuals with no contraindication to~     receiving GH, will participate in the study for 12 months. Individuals with normal GH levels,~     or who are GH deficient and have a contraindication to receiving GH, will be asked to return~     for one more visit (without any interventions).~   "
257331|NCT00182078|"~     The broad, long-term objectives of this proposal are to prevent the emergence of~     posttraumatic stress and depressive symptoms in children admitted for an acute burn,~     reconstructive surgery, or non-burn injury. This study is investigating the early use of a~     medication in the prevention of posttraumatic stress disorder and depression. Specific Aims 1~     and 2: To assess the efficacy of sertraline to prevent the development of (Aim~     1)posttraumatic stress disorder and (Aim 2)depression in children aged 6-20, after burn or~     non-burn injury or after reconstructive surgery. Hypotheses 1 and 2: Administration of~     sertraline after an acute burn or non-burn injury, or after reconstructive surgery will lead~     to greater reduction in post-traumatic and depressive symptoms over 12 and 24 weeks, compared~     with placebo.~      This study is completing the evaluation of 90 children and adolescents, aged 6-20 years. It~     is comparing 60 subjects receiving sertraline with 30 placebo control subjects matched for~     age, severity of injury, and type of hospitalization (acute vs. reconstructive). Children and~     families are evaluated for the presence of acute stress symptoms. Children are reassessed in~     a double-blind placebo-controlled design, with evaluations at Baseline, Week 2, Week 4, Week~     8, Week 12, and Week 24. In addition, there is weekly monitoring for the first 14 weeks of~     the study and again at 18 weeks (the midpoint of the study). At each reassessment,~     information is collected on the child's compliance with the study medication, the parents'~     assessment of the child's functioning, and the child's self-report of posttraumatic and~     depressive symptomatology. The main outcome variable used in this study is the child's~     posttraumatic symptoms.~   "
257359|NCT00181714|"~     This study will consist of a six-week open-label treatment period with an extended duration~     methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large~     sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders,~     Fourth Edition (DSM-IV) criteria for ADHD.~      The researchers hypothesize that OROS MPH treatment will be associated with low rates of~     cigarette smoking in ADHD youth.~   "
257332|NCT00182065|"~     Heart failure is very common in the elderly, in whom it may lead to functional and~     intellectual problems. Functional problems include loss in the ability to perform basic tasks~     of daily living such as bathing or dressing. No studies have yet described the rate at which~     heart failure causes these problems to develop. This study aims to find out whether nursing~     home patients deteriorate more quickly with respect to function and intellect if they have~     heart failure. Participants will undergo a thorough health history and physical examination~     and will be followed every 3 months for up to a year. Over 30 nursing homes in Kitchener,~     Waterloo, Cambridge, and Hamilton, in South Central Ontario (Canada), are participating in~     this study. Every 3 months, participants will be reviewed with respect to function,~     intellect, mood and behaviours. Results between those with heart failure will be compared to~     those of people without heart failure. The results of this study will be used to plan further~     studies to see whether good treatment of heart failure can preserve function, intellect, and~     prevent depression and other mood problems.~   "
257333|NCT00182052|"~     The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on~     patients and their prostate cancer. This study is going to look at what effects rosiglitazone~     has on prostate specific antigen (PSA) levels.~   "
257334|NCT00182039|"~     This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart~     attacks and deaths around the time of surgery.~   "
257335|NCT00182026|"~     The purpose of this study is to test whether providing personalized diabetes self-management~     recommendations and feedback improves blood sugar control more than providing generalized~     diabetes educational material alone.~   "
257336|NCT00182013|"~     The objective of this study is to compare the safety and effectiveness of Risperidone,~     Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar~     disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label~     study, which seeks to determine if there is evidence for efficacy. The results of this study~     will be used to generate hypotheses for a larger study.~   "
257337|NCT00182000|"~     This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the~     positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).~   "
257338|NCT00181987|"~     The objective of this study is to investigate the safety and effectiveness of Concerta in the~     treatment of children (ages 5 to 17 years old) and adults (ages 18 to 55 years old) with~     Bipolar I, Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks. This~     study seeks to study the short-term effectiveness of a long acting formulation of~     methylphenidate (Concerta) in the treatment of children and adults with bipolar disorder and~     comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents.~   "
257339|NCT00181974|"~     The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery~     with respect to hemostasis and skin graft fixation.~   "
257340|NCT00181961|"~     The purpose of this study is to determine the dose of Maca Root effective for the treatment~     of antidepressant-induced sexual dysfunction in patients with DSM-IV defined Major Depressive~     Disorder. We propose to carry out a dose-finding pilot study to determine the minimum~     effective dose of Maca Root. We hypothesize that patients who receive Maca Root will~     experience alleviation of their sexual dysfunction, and this effect will be more pronounced~     in those who receive higher doses of maca root.~   "
257341|NCT00181948|"~     This will be a 6-week, unblinded study using the medication Strattera for children and~     adolescents with attention deficit hyperactivity disorder (ADHD) who failed to respond to an~     adequate trial of stimulant treatment. Specific hypotheses are as follows:~      Hypothesis 1: ADHD symptomatology in youth with ADHD will be responsive to Strattera~     treatment in the short term.~      Hypothesis 2: Strattera treatment (in doses of up to 120 mg/day or 1.2 mg/kg/day) in children~     and adolescents with ADHD will be safe and well tolerated.~   "
257342|NCT00181935|"~     The objectives of this study are to study the safety, effectiveness, tolerability and dosing~     regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and~     Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these~     atypical neuroleptics may be effective in treating pediatric mania, with a lower risk of~     extrapyramidal side effects.~   "
257343|NCT00181922|"~     The objective of this study is to compare the safety and effectiveness of Ziprasidone in the~     treatment of mania in children and adolescents with Bipolar disorder over 8 weeks. This is an~     exploratory, open-label study, which seeks to determine if there is evidence for efficacy.~     The results of this study will be used to generate hypotheses for a larger study.~   "
257344|NCT00181909|"~     The principal objective is to test whether offering pregnant smokers a proactive telephone~     counseling program throughout pregnancy and for 2 months postpartum increases the rate of~     smoking cessation at end of pregnancy and 3 months postpartum, compared to a “best practice”~     control condition.~   "
257345|NCT00181896|"~     This is an 8-week open label study of bupropion SR in the treatment of youth with bipolar~     depression with adequate mood stabilization. All youth will be closely monitored for~     treatment emergent manic activation and drug-drug interactions with ongoing antimanic agents.~      The main objective of this study is to assess the safety and effectiveness of bupropion SR in~     the treatment of bipolar depression in children and adolescents.~   "
257346|NCT00181883|"~     This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of~     Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar~     spectrum disorder. This is an exploratory, pilot study, seeking to determine whether~     Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric~     bipolar and bipolar spectrum disorder in this age group. The study results will be used to~     generate hypotheses for a larger randomized controlled clinical trial with explicit~     hypotheses and sufficient statistical power.~   "
257347|NCT00181870|"~     This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the~     treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum~     Disorder. The main goal of this study is to begin to address the void of information on~     safety, tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar~     Disorder.~   "
257435|NCT00180544|"~     The purpose of this study is to evaluate the safety and effectiveness of the RX HERCULINK 14~     Peripheral Stent System in treating atherosclerotic renal artery stenosis.~   "
257348|NCT00181857|"~     The researchers plan to explore the validity of the category of ADHD NOS by identifying the~     risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of~     ADHD in these children. The researchers hypothesize that the rate of ADHD will be higher in~     the children of the ADHD NOS probands than the rate of ADHD previously published for siblings~     of proband children with ADHD; and ADHD children of ADHD NOS adults will have higher rates of~     school failure (as measured by their rate of repeated grades, need for tutoring, and~     placement in special classes) than their non-ADHD siblings.~   "
257349|NCT00181844|"~     The main objective of this study is to assess the effectiveness and safety of lamotrigine in~     the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory,~     12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV~     diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study~     results will be used to generate hypotheses for a larger randomized controlled clinical~     trial. Based on the available literature in adults with bipolar disorder, we hypothesized~     that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and~     bipolar spectrum disorders.~   "
257350|NCT00181831|"~     The primary aim of this study is to use proton magnetic resonance spectroscopy to look at~     myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior~     cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of~     risperidone treatment and 20 children with bipolar disorder after an eight-week or longer~     treatment with risperidone. For comparison, results will also be obtained from 20 controls~     (without bipolar disorder or ADHD) of the same age and gender as well as from 20 children or~     adolescents with a diagnosis of Attention Deficit Hyperactivity Disorder. We hypothesize that~     Ino/Cr levels in the anterior cingulate will correlate positively with manic symptoms using~     the Young mania rating scale (YMRS). Ino/Cr levels in the anterior cingulate in the anterior~     cingular gyrus will be lower in subjects who have received eight weeks or longer of~     risperidone~   "
257351|NCT00181818|"~     The purpose of the study is to test the efficacy and safety of bupropion SR for smokers~     hospitalized with acute cardiovascular disease.~   "
257352|NCT00181805|"~     The goal of this project is to determine the long-term health outcome of children diagnosed~     with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in~     the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have~     compiled a database of more than 300 subjects that completed diagnostic testing for GER in~     the 1970's, 1980's, and 1990's. Subjects are being contacted initially by mail using a~     previously approved recruitment letter. Subjects that fail to respond to this recruitment~     letter are called by phone. In each case, contact information has been abstracted from the~     Children's Hospital database. Subjects are then given the opportunity to complete a~     questionnaire either by phone or in hard copy. Subjects receive no compensation for their~     participation in this study. Subjects will be compared to controls. Controls will complete~     the same questionnaire as the subjects. Inclusion of potential controls will be determined by~     a lack of medical history of gastroenterological diseases before the age of 21 and whether~     the potential control was born within a year of a subject in the study. Controls will receive~     $25 to participate in the study.~   "
257353|NCT00181792|"~     The researchers will study 100 families over three years, each with a child (proband) between~     the ages of 12-17, with the Diagnostic and Statistical Manual of Mental Disorders, Fourth~     Edition (DSM-IV) diagnosis of ADHD. The researchers hypothesize smoking will be familial and~     ADHD probands with a family history of tobacco use will be at increased risk for early~     initiation and persistence of smoking, compared to ADHD probands with no family history of~     tobacco use.~   "
257354|NCT00181779|"~     This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania~     in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8~     weeks. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is~     efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar~     spectrum disorder. The study results will be used to generate hypotheses for a larger~     randomized controlled clinical trial with explicit hypotheses and sufficient statistical~     power.~   "
257355|NCT00181766|"~     This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the~     treatment of adults with attention deficit hyperactivity disorder not otherwise specified.~     The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to~     Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1.5 mg/kg/day,~     whichever is less) in adults with ADHD NOS will be safe and well tolerated.~   "
257356|NCT00181753|"~     The purpose of the study is to understand how the body uses amino acids in burned patients~     during the time they cannot eat normally. Amino acids occur naturally in the body and the~     food we eat. The body combines amino acids to make protein. It uses the proteins to do things~     such as heal wounds, fight infection, and provide energy. We are studying two ways of~     receiving nutrition: through a vein or through a tube. We are also studying two different~     types of food: with or without glutamine. The results of this study will be used to determine~     the best type and way to supply nutrients during a severe burn injury. We hope to learn how~     to help the body use nutrients more efficiently to better repair wounded tissues and recover~     earlier from injury.~   "
257357|NCT00181740|"~     This will be an open label pilot study of Concerta in the treatment of adults with the~     diagnosis of Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS). We~     hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Concerta~     treatment in the short term and Concerta-associated response of ADHD symptomatology in adults~     with ADHD NOS will be sustained over the medium term.~   "
257358|NCT00181727|"~     This is an open-labeled study of Divalproex Sodium Extended Release (Depakote ER), testing~     its efficacy for the treatment of mania in children between the ages of 6-12 who have been~     diagnosed with Bipolar I, Bipolar II, and Bipolar Spectrum Disorders. This is an exploratory,~     pilot study, seeking to determine whether Divalproex Sodium Extended Release is efficacious~     and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum~     disorder, and the study results will be used to generate hypotheses for a larger randomized~     controlled clinical trial with explicit hypotheses and sufficient statistical power.~   "
257552|NCT00178997|"~     The purpose of this study is to look at the electrical activity present in healthy and~     diseased smooth muscle of the intestines; and develop both mathematical and computer models.~   "
257360|NCT00181701|"~     The main purpose of this study is to determine the safety and tolerability of giving both~     paclitaxel and carboplatin in the abdominal cavity by looking at what effects (good and bad)~     this route of administration has on patients with ovarian cancer. Standard chemotherapy drugs~     are administered intravenously but a number of trials have shown that injecting drugs into~     the abdominal cavity, or intraperitoneally, have shown promising results.~   "
257361|NCT00181688|"~     The main purpose of this study is to determine the effects (good and bad) Iressa plus~     anastrozole has on patients with relapsed ovarian cancer.~   "
257362|NCT00181675|"~     This will be a double-blind, placebo-controlled, study using daily doses of up to 24 mg/ day~     Galantamine HBr in the treatment of adults who meet DSM-IV criteria for childhood-onset ADHD.~     Specific hypotheses are as follows:~      Hypothesis 1: ADHD symptomatology in adults with DSM-IV ADHD will be responsive to acute~     Galantamine HBr treatment.~      Hypothesis 2: Galantamine HBr -associated improvement in ADHD symptomatology in adults will~     translate into improved functional capacities (neuropsychological, social, and occupational)~     as well as an increased quality of life throughout acute treatment.~      Hypothesis 3: Galantamine HBr treatment will be safe and well tolerated as reflected by a low~     drop out rate and absence of major differences from placebo.~   "
257363|NCT00181662|"~     This study looks to describe the pharmacokinetics of curcumin delivered as a single oral dose~     in healthy female volunteers. The impact of piperine and silybin on the pharmacokinetics of~     curcumin is also studied.~   "
257364|NCT00181649|"~     The purpose of the study is to assess the safety and determine the effects of the hormone~     prolactin on lactation (breast milk production).~   "
257365|NCT00181636|"~     The purpose of the study is to determine whether the investigational drug galantamine-CR~     (Reminyl- Controlled Release capsule) is useful in improving problems with memory in bipolar~     patients with stable mood. This study is being done because a large proportion of patients~     with bipolar disorder experience significant memory problems, even when their mood is stable,~     after adequate treatment. These memory problems have been associated with poor daily social~     functioning. Studying galantamine-CR in this population may provide a new clinical way to~     combat memory problems in stable patients with bipolar disorder.~   "
257366|NCT00181623|"~     The purpose of the study is to assess the safety and determine the effects of the hormone~     prolactin on lactation (breast milk production).~   "
257367|NCT00181610|"~     The purpose of the study is to assess the safety and determine the effects of the hormone~     prolactin on lactation (breast milk production).~   "
257368|NCT00181597|"~     The main purpose of this study is to test the safety of trilostane by looking at what~     effects, good and bad, it has on patients with androgen-independent prostate cancer.~   "
257369|NCT00181584|"~     The primary objective of this study is to determine whether zoledronic acid (Zometa) given~     once annually increases bone mineral density in men receiving hormone therapy for prostate~     cancer.~   "
257370|NCT00181571|"~     This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of~     Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit~     hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults~     with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of~     ADHD symptomatology in adults will be sustained over time.~   "
257371|NCT00181558|"~     The main purpose of this study is to look at the effects (good or bad) that Atrasentan given~     alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction~     in men with prostate cancer that has spread to the bones.~   "
257372|NCT00181545|"~     Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the~     local control rate is low and the radiation often causes pneumonitis and/or esophagitis.~      To predict to lung damage the mean lung dose can be calculated. This allows us to give a~     higher total dose to the tumor and to improve the local control rate.~      Study hypothesis: It will be safe to administer a radiation dose as high as possible to the~     tumor, taking into account the mean lung dose, calculated by the treatment planning system.~   "
257373|NCT00181532|"~     The purpose of this study is to investigate the effect of the adminstration of celecoxib, a~     cox2-inhibitor in patients with stage II-III non small cell lung cancer receiving radical~     radiotherapy.~      The hypothesis is that celecoxib will increase the remission rate of radiotherapy.~   "
257374|NCT00181506|"~     In this study we try to increase the radiation dose, while reducing or keeping the radiation~     schedule below 4 weeks.~      The study hypothesis is that it is feasible to administer hyperfractionated accelerated~     radiotherapy to patients with inoperable or locally advanced non small cell lung cancer.~   "
257375|NCT00181363|"~     We hypothesize that for large pendulous breasts, breast irradiation in supine and prone~     position are equivalent with regard to coverage of the PTV, but with a better dose~     homogeneity in prone position and a smaller radiation exposure of lung and heart.The purpose~     of this study is to compare the 3-D dose distribution in PTV and normal tissues in prone~     position versus supine position.~   "
257376|NCT00181350|"~     This study aims at providing a quantitative evaluation of the accuracy of two different~     fixation systems, where one system is also evaluated with two different set-ups.~   "
257377|NCT00181311|"~     The purpose of this study is to evaluate the short and long term complications after an~     abdominal or vaginal hysterectomy and to detect the prevalence of occult/subclinical~     haematomas and vaginal cuff abscesses and the postoperative course of these.~      The investigators will also evaluate the physical and mental well being after a hysterectomy~     with a questionnaire and correlate these results with the occurrence of complications.~   "
257378|NCT00181298|"~     Neuropsychiatric manifestations of Systemic Lupus Erythematosus (NPSLE) are both common and~     an important source of morbidity. Of the case definitions for NPSLE syndromes that have~     recently been developed, cognitive dysfunction appears to be the most prevalent. A novel~     mechanism is that a subset of SLE patients with cognitive dysfunction have antibodies in the~     NR2 glutamate receptor. We propose, in a double -blind placebo-controlled trial, to determine~     whether SLE patients, with or without the NR2 glutamate receptor antibody, have significant~     improvement using memantine, an inhibitor of the NMDA receptor.~   "
257436|NCT00180531|"~     The objective of this study is to evaluate the prevalence of sustained ventricular and~     supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular~     resynchronization therapy (CRT) device~   "
257379|NCT00181285|"~     The purpose of this study is to determine whether inpatient use of a high frequency chest~     wall oscillator is an effective therapy for patients hospitalized with asthma exacerbations~     or chronic obstructive pulmonary disease (COPD) exacerbations.~      The investigators hypothesize that inpatient use of HFCWO will promote clearance of airway~     secretions, leading to more rapid resolution of severe asthma and COPD exacerbations and~     lower rates of re-exacerbations after hospital discharge.~   "
257380|NCT00181272|"~     The purpose of this study is to determine whether macrolide therapy is effective in treating~     patients hospitalized with asthma exacerbations or chronic obstructive pulmonary disease~     (COPD)exacerbations. We hypothesize that compared to placebo, maintenance therapy with~     macrolides, when added to usual care, a) improves respiratory symptoms, b) improves quality~     of life, c) reduces airway inflammation, d) reduces airflow obstruction, and e) decreases the~     rate of re-exacerbations.~   "
257381|NCT00181259|"~     The metabolism of the heart provides the chemical energy needed to fuel ongoing normal heart~     contraction. Magnetic resonance spectroscopy is a technique used in a MRI scanner that can be~     used to measure and study heart metabolism directly but without blood sampling or obtaining~     tissue biopsies. One of the hypotheses this study aims to investigate is whether energy~     metabolism is reduced in heart failure and whether that contributes to the poor heart~     function.~   "
257382|NCT00181246|"~     The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established,~     although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has~     been shown to be effective for treating other types of pain. We propose to measure functional~     outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain.~     Measures will be made at baseline and after titrating the drug to an effective level.~   "
257383|NCT00181233|"~     Sudden cardiac death is a tragic event that strikes all age groups and is unfortunately~     increasing in prevalence. Because it is difficult to predict those at highest risk, this~     study is designed to test the hypothesis that new imaging techniques (magnetic resonance~     imaging [MRI] and computed tomography [CT]) are useful for identifying factors which put~     people at high risk for sudden death.~   "
257384|NCT00181220|"~     The proposed study will test the safety and efficacy of sodium valproate in the induction of~     Epstein-Barr virus (EBV) lytic cycle antigen expression in tumor tissue of patients~     undergoing primary therapy for nasopharyngeal carcinoma. Up to 20 patients will be given~     valproic acid for 2 weeks. The primary surrogate endpoint for efficacy will be expression of~     EBV lytic antigens by immunohistochemistry in tumor tissue. Biopsies of primary tumor will be~     taken after 2 weeks with achievement of a therapeutic concentration of valproate. Expression~     of immunodominant EBV latency antigens in tumor tissue, EBV viral load by real time PCR, and~     valproate levels will be measured. Adverse events associated with valproate in NPC patients~     will be described.~   "
257385|NCT00181207|"~     The purpose of this study is to show that one form of mechanical airway clearance techniques,~     High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish~     exacerbations of COPD which will improve respiratory health status.~   "
257386|NCT00181194|"~     The purpose of this study will be to assess the impact of a culturally-sensitive,~     patient-focused asthma communication instrument (ACCI) designed to enhance provider-patient~     communication by prompting and guiding providers in assessments of disease severity and~     discussion of adherence behaviors with minority patients with asthma.~   "
257387|NCT00181181|"~     This research is being done to find if treatment with atorvastatin, a drug that reduces~     cholesterol, improves the function of blood vessels among people with high blood pressure.~     Adults with mildly high blood pressure, or who are taking medication for high blood pressure~     but are otherwise healthy may join, with the approval of their health care provider. The~     study period is 14-17 weeks. Approximately 50 to 60 subjects will take part in the study.~   "
257388|NCT00181168|"~     The purpose of this study is to determine [for patients with previously treated~     well-differentiated thyroid cancer and evidence of residual disease based on serum~     thyroglobulin (Tg) level] whether positron emission tomography-computed tomography (PET-CT)~     fusion scanning performed after recombinant TSH (rTSH, thyrotropin alfa for injection) will~     be more sensitive for the detection of disease sites than PET-CT scanning without rTSH. The~     study will also determine if this information will significantly alter the therapeutic~     approach in some patients.~   "
257389|NCT00181155|"~     This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves~     heart metabolism in patients with heart failure.~   "
257390|NCT00181142|"~     The purpose of this study is to compare outcomes in patients undergoing lung transplantation,~     using 2 different induction therapies. Primary outcome is survival and secondary outcomes~     include freedom from infection and freedom from rejection.~   "
257391|NCT00181129|"~     The purpose of this randomized controlled trial is to determine the effects of a~     nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical~     functioning during adjuvant therapy for cancer. The sample will be randomized into exercise~     (EX) or usual care (UC) groups. The independent study variable is participation in a walking~     exercise program. Outcomes include: fatigue, sleep disturbance, emotional distress, physical~     functioning and quality of life. The effects of the walking exercise program will be~     evaluated using self-report questionnaires administered pre- and post-treatment, patient~     diaries, and symptoms assessments at defined intervals during adjuvant therapy~   "
257392|NCT00181116|"~     This study is designed to test if the language problems commonly seen in children with benign~     rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.~   "
257393|NCT00181090|"~     This study is designed to further investigate the use of a modified Atkins diet for children~     with intractable, daily seizures. It is a follow-up to a study recently completed by our~     institution. In this 6-month study, children will be randomized to either 10 or 20 grams of~     carbohydrate per day, then crossed over to the opposite amount at 3 months.~   "
257394|NCT00181077|"~     To compare hypertonic saline to Lactated Ringer's solution and assess whether one speeds up~     the process of getting rid of extra body water faster in women with preeclampsia.~   "
257395|NCT00181064|"~     This is a 3-month pilot study of 10 adolescents with chronic daily headache. Teens will be~     placed on a modified Atkins diet and followed with 2 subsequent visits to assess for headache~     improvement.~   "
257396|NCT00181051|"~     Index computed in real time from Auditory Evoked Potentials have been described parallel to~     depth of anesthesia. The goal of the study was to compare general anesthesia guided on~     Auditory Evoked Potentials monitoring to standrad practice in order to assess if AEP~     monitoring can improve recovery delay (main criteria) or intraoperative hemodynamic stability~     (secondary criteria). Patients were randomized in 2 groups, stratified by center. Group I :~     AEP guided anesthesia, Group II: Blind AEP record, standard practice.~   "
257397|NCT00181038|"~     This trial examines the analgesia of the fibula free flap donor site by peri-neuronal~     catheter in oro-pharyngeal carcinoma surgery by comparing continuous infusion of a local~     anesthetic with systemic multimodal analgesia.~   "
257398|NCT00181025|"~     This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis~     factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs’~     girdle.~   "
257399|NCT00181012|"~     This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain~     resistant to morphinics. It is an efficacy study in adults and children and a randomized~     prospective study.~   "
257400|NCT00180999|"~     Randomised study to compare the effect of r-Hu-EPO administration with transfusion of Red~     Blood cell concentrates and also with the administration of polyvitamins in anemic and tired~     patients presenting a bad prognostic in middle course.~   "
257401|NCT00180986|"~     Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In~     Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child~   "
257402|NCT00180973|"~     MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY~     (BEC REGIMEN) FOLLOWED BY STANDARD RADIOTHERAPY (70 Gy / 7 WEEKS) VERSUS THE SAME NEOADJUVANT~     CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE~     TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE (UCNT).~   "
257403|NCT00180960|"~     The purpose of this study is to evaluate the treatment of a cancerous disease of the~     peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using~     oxaliplatin plus irinotecan.~      This is a Phase II study with 100 patients. Origins of the tumors: these include colon,~     rectum, appendix, peritoneum, and endocrine tumors.~   "
257404|NCT00180947|"~     This is a phase II study to determine the antitumor activity of Vinorelbine and~     Cyclofosfamide association among patients with refractory tumours or in relapse with~     rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas~     or medulloblastomas.~   "
257405|NCT00180934|"~     Interest of a reirradiation with concomitant chemotherapy after salvage surgery for~     recurrence of head and cancer in irradiated area : a multicentric Phase III randomized trial~   "
257406|NCT00180921|"~     This is a Phase II study of imatinib (Glivec) administered as a daily oral treatment in~     patients with recurrent/metastatic adenoid cystic carcinoma of the head and neck~     overexpressing KIT.~   "
257407|NCT00180908|"~     The purpose of this study is to compare two preoperative chemotherapy regimens based on~     high-dose methotrexate courses given alternately either with doxorubicin or with~     etoposide-ifosfamide.~   "
257408|NCT00180895|"~     This is a multicentric phase II study of Mabthera (rituximab) in children and adolescents~     with relapsed and refractory B-cell NHL/L3ALL. The primary objective is to determine the~     response rate of Rituximab as single agent in relapsed or refractory Burkitt lymphoma, L3~     acute leukemia, large B-cell lymphoma and non subclassified aggressive B-cell NHL~   "
257409|NCT00180882|"~     To explore in a multicenter international prospective randomized study (phase III) whether~     rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate~     of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt~     lymphoma or ALL 3.~   "
257410|NCT00180869|"~     There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have~     immunomodulatory effects. The aim of this randomized single-center trial is to compare immune~     responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC)~     or a leuko-reduced RBC (LR-RBC) transfusion perioperatively.~   "
257411|NCT00180856|"~     Radiofrequency ablation has achieved impressive results in the treatment of unresectable~     primary and metastatic liver cancer. Animal studies have demonstrated that radiofrequency can~     fully ablate lung tumors in animal models. We set up a prospective study to evaluate the~     local efficacy of radiofrequency ablation of lung neoplasms. The aim of the study is to~     prospectively evaluate local efficacy with a minimal follow-up of one year, tolerance, lung~     disease-free survival and survival after radiofrequency ablation of lung tumors (primary lung~     cancer or lung metastases).~   "
257412|NCT00180843|"~     Subjects undergo history, examination, lung function assessment after informed consent has~     been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is~     normal they will undergo a second and final scan four weeks later. If abnormal they will~     undergo two further scans with either nebulized bronchodilator or nebulized saline prior to~     their second and third scans. Each time they will have repeat lung function tests prior to~     scanning. We will examine the regional changes in ventilation and perfusion and there~     relationship to lung function.~   "
257413|NCT00180830|"~     The purpose of this study is to determine whether Glivec is effective, in children,~     adolescents and young adults, in the treatment of malignant disease in which evidence~     suggests a potential pathogenic role of one or more of the tyrosine kinases known to be~     inhibited by Glivec.~   "
257414|NCT00180817|"~     This study is being done to see if there are any long term health related issues in women~     with APA and recurrent miscarriages.~   "
257415|NCT00180804|"~     For implantation of developing conceptus, placental cells need to invade mother's uterus to~     access maternal blood supply in a control manner. We have found a combination of maternal~     immune genes (the KIR family) and fetal genes (HLA-C) strongly associated with pre-eclampsia~     where placenta does not implant adequately. The aim of this research is to investigate these~     two genes family in women suffering with recurrent miscarriages and find a possible link~     between them.~   "
257416|NCT00180791|"~     The purpose of this study is to evaluate the efficacy of the combination of surgery,~     conventional chemotherapy, sequential high-dose chemotherapy with peripheral blood stem cell~     transplantation and reduced dose radiation therapy in high-risk PNET brain tumors.~   "
257417|NCT00180778|"~     Does the addition of steroids during the first trimester to the standard aspirin + heparin~     treatment reduce the miscarriage rates in women with antiphospholipid antibodies and~     recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin~     + heparin?~   "
257418|NCT00180765|"~     Chronic obstructive pulmonary disease (COPD for short) involves inflammation inside the air~     passages of the lungs. This inflammation might be partly responsible for the shortness of~     breath, cough and susceptibility to chest infections that form part of COPD. Inflammation is~     caused, in part, by white blood cells that are attracted from the blood into the air~     passages. Once inside the air passages, the white blood cells may change (or 'differentiate')~     and release substances that produce inflammation and attract more white cells. The hypothesis~     is that the lifespan of these cells may also be prolonged such that they produce more~     inflammatory mediators and in turn perpetuate inflammation. The cycle of inflammation may~     damage the lungs, so we want to see what mediators are released by white blood cells and~     determine if we can inhibit this effect with existing and new drugs. We would also like to~     see the effect of these drugs on the life-span and function of white blood cells. We will~     compare the behaviour and characteristics of white cells with those from healthy smokers and~     healthy non-smokers to find out if there is anything different about cells from COPD~     patients.~   "
257419|NCT00180752|"~     We wish to study the effect of Chronic Obstructive Pulmonary Disease on the activity of the~     nuclear transcription pathway in peripheral skeletal muscle to determine whether altered~     activity of this pathway may be responsible for the muscle dysfunction observed in these~     patients.~   "
257420|NCT00180739|"~     The study objective is to develop data for the safety of pregnancies after thermal ablation~     of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.~   "
257421|NCT00180726|"~     The aim of this study is to investigate the mechanisms whereby lung function is decreased in~     asthma and sensitivity to treatment. The hypothesis is that in diseases such as asthma,~     inflammatory cells (leukocytes) including eosinophils, macrophages and lymphocytes migrate to~     the lung and release either more or different types of inflammatory mediators and/or~     receptors compared to subjects without asthma, which are corticoid sensitive or insensitive.~     The objective of the study is to identify which genes are specifically expressed in important~     cells in patients with asthma with a view to identify novel targets for drug therapy.~   "
257422|NCT00180713|"~     The purpose of the study is to investigate the safety and efficacy of adding simvastatin to~     the current conventional treatment regimen for the management of pulmonary hypertension.~   "
257423|NCT00180700|"~     This study examines the hypothesis that psychological interventions have beneficial effects~     on quality of life including psychological well-being and disease progression in early HIV~     patients recieving no medication.~   "
257424|NCT00180687|"~     Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control,~     one will have local anaesthetic and the third will have normal saline nebulised into their~     abdomen before closure of the wounds to reduce postoperative pain. These medications will be~     given on top of the standard pain management protocol.~   "
257425|NCT00180674|"~     Patients who have been treated for hepatitis C virus (HCV) infection who have failed to~     respond to anti-viral treatment are often concerned about their ongoing liver disease and are~     therefore looking for alternative treatments which might prevent fibrosis progression. This~     view is endorsed by patient representative groups (including Charles Gore at the HepC Trust)~     who have welcomed this trial protocol.~      The trial will be a randomised cross over study with 15 patients in each group. Each patient~     will receive eight weeks of anticoagulation and eight weeks of observation.~   "
257426|NCT00180661|"~     Some patients with mild asthma may develop severe asthma. It is not known what makes patients~     with mild asthma become severe, and we plan to find out why this happens. Patients with~     severe asthma may have a different type of inflammation in the airway tubes. Patients with~     severe asthma do not get as much benefit from taking steroid inhalers or tablets compared to~     asthma patients with mild disease. The study hypothesis is that the inflammation in severe~     asthma is such that it makes steroids less effective in treating asthma. We will find out~     what possible abnormalities there are in the blood cells and the bronchoalveolar macrophage~     cells in the lungs of patients with severe asthma compared to those with mild or moderate~     asthma.~   "
257427|NCT00180648|"~     The purpose of this study is to investigate the theory that the plasma level of Glucagon like~     peptide 2 (GLP-2) in patients with intestinal failure can predict their clinical recovery.~   "
257428|NCT00180635|"~     The primary aim of this study is to investigate the effects of oral and inhaled~     administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled~     NO and NO metabolites in exhaled breath condensate, induced sputum, nasal lavage and mouth~     wash fluid in healthy non-smokers, current smokers and patients with COPD.~   "
257429|NCT00180622|"~     The primary aim of this study is to exploit a difference between COPD patients, chronic~     smokers without COPD and healthy non-smoking subjects. This will help to assess the utility~     of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the~     lung function, clinical parameters and computerised tomography (CT).~   "
257430|NCT00180609|"~     The primary objective of this study is to document the success rate of the automatic~     threshold testat pre-discharge in a normal pacemaker patient population implanted with~     Guidant Insignia Ultra or AVT .~   "
257431|NCT00180596|"~     The purpose of this study was to evaluate the benefit of biventricular pacing in patients~     with heart failure who were receiving optimal pharmacological therapy, and who were either~     with or without an ICD indication~   "
257432|NCT00180583|"~     To assess the safety and effectiveness of intravascular brachytherapy for the treatment of~     intrastent restenosis of coronary lesions with the Galileo system~   "
257433|NCT00180570|"~     Randomised Comparison with regards to complication rate and electrical measurements of atrial~     leads with different fixation mechnism~   "
257434|NCT00180557|"~     In this study the difference between screw in leads actively fixed in the septum and tined~     leads passively fixed in the apex concerning electrical parameters and implantation time will~     be evaluated. In addition the influence of the stimulation location by type of lead on QRS~     width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and~     echocardiogram.~   "
257437|NCT00180518|"~     1. To evaluate the safety and efficacy of the over-the-wire (OTW) ACCULINK (tm) System in~          patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA)~        2. To evaluate the efficacy of the OTW ACCUNET System in patients deemed to be either at~          high risk or unsuitable for carotid endarterectomy (CEA).~        3. To demonstrate equivalence in the safety and performance of the RX ACCULINK Carotid~          Stent System and RX ACCUNET Embolic Protection System and the corresponding OTW devices.~   "
257438|NCT00180505|"~     The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral~     self-expanding stent system in preventing restenosis of occluded or stenotic superficial~     femoral or proximal popliteal arteries.~   "
257439|NCT00180492|"~     This purpose of this study is to collect data on the FDA-approved ACCULINK(TM) Carotid Stent~     System and FDA 510(k)-cleared ACCUNET(TM) Embolic Protection System for the treatment of~     patients with atherosclerotic disease, when used by physicians under commercial use~     conditions.~   "
257440|NCT00180479|"~     This study is divided into 5 arms:~        1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single~          blind, parallel two-arm multi-center clinical trial in the United States (US) comparing~          XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter~          stents) to the Food and Drug Administration (FDA) approved commercially available active~          control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS)~          System~        2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS~        3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS~        4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS~        5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0~          mm diameter stents) in Japan~      The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston~     Scientific.~   "
257441|NCT00180466|"~     PROSPECT is a multi-center prospective registry of Acute Coronary Syndromes (ACS) patients~     with single or double vessel coronary artery disease. Approximately 700 patients with ACS~     will be enrolled into the study at sites in the United States and European Union.~   "
257442|NCT00180453|"~     Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial.~      Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter:~     3.0mm) Control arm: Metallic stent (MULTI-LINK VISION® metallic stent(stent length: 18mm,~     diameter: 3.0mm) Follow-up angiographic imaging and intra vascular ultra sound (IVUS) at 180~     days and 1 year~   "
257443|NCT00180440|"~     The INSURE trial is a multi-center, prospective trial to collect information about adequate~     ICD therapies in ICD patients before and after their first elective ICD replacement.~   "
257444|NCT00180427|"~     The purpose of this study is to evaluate the influence of the rate response function of~     implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in~     patients with an ICD.~   "
257445|NCT00180414|"~     This study will look at the correlation between ventricular rate regulation (VRR) and the~     percentage of biventricular pacing as well as subjective quality of life and level of~     physical ability in CRT patients with atrial fibrillation.~   "
257446|NCT00180401|"~     The purpose of this study is to compare the benefit of cardiac resynchronization therapy~     (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of~     > 150 ms.~   "
257447|NCT00180388|"~     The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of~     life and wound healing after endoscopic vein harvesting versus open vein harvesting.~   "
257448|NCT00180375|"~     This study evaluates the date of the first appropriate and/or inappropriate therapy in~     patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual~     predictive risk factors for appropriate/inappropriate therapies as well as the influence of~     the programmed parameters on these therapies.~   "
257449|NCT00180362|"~     The purpose of this study is to evaluate the strategy of implanting an ICD with or without~     EPS before, during and after ICD-implantation in a randomised controlled trial, using a~     combined endpoint of major ICD-related adverse events as the primary outcome measure.~   "
257450|NCT00180349|"~     The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™~     defibrillation leads connected to a defibrillator or a cardiac resynchronization~     defibrillator from implant until 12 months.~   "
257451|NCT00180336|"~     The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4~     AVT device.~   "
257452|NCT00180323|"~     This prospective study will evaluate in patients, fulfilling implant criteria for Cardiac~     Resynchronisation Therapy (CRT) implant, the optimal atrial contribution to the~     resynchronised ventricles in the event of right atrial pacing.~   "
257453|NCT00180310|"~     Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical~     trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved~     commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent~     System.~      TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston~     Scientific.~   "
257454|NCT00180297|"~     The purpose of this study is to determine the safety and efficacy of the implant of a ICD~     lead of defibrillation in the septum of the right ventricle~   "
257455|NCT00180284|"~     The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical~     performance of the SITELINE 2 Polyurethane pacing lead.~   "
257456|NCT00180271|"~     The MADIT-CRT trial is designed to determine if combined implantable cardiac defibrillator~     (ICD)-cardiac resynchronization therapy (CRT-D) will reduce the risk of mortality and heart~     failure (HF) events by approximately 25%, in subjects who are in New York Heart Association~     (NYHA) functional Class II with non-ischemic or ischemic cardiomyopathy and subjects who are~     in NYHA functional Class I with ischemic cardiomyopathy, left ventricular dysfunction~     (ejection fraction [EF] < or = 0.30), and prolonged intraventricular conduction (QRS duration~     > or = 130 ms).~   "
257457|NCT00180258|"~     The purpose of this study is to determine whether combined mortality and hospitalization in~     heart failure patients receiving optimal pharmacologic therapy can be reduced by combining~     optimal pharmacologic therapy and 1) biventricular pacing therapy alone or 2) biventricular~     pacing with defibrillation.~   "
257460|NCT00180219|"~     This is a single-centre, open, parallel-group study with three age groups; no study~     medication or intervention will be provided. This is a longitudinal follow-up of~     physiological parameters.~   "
257461|NCT00180206|"~     The purpose of this study is the investigation of the functional and radiological results and~     subjective patient outcome after the implantation of a hip resurfacing endoprosthesis~     (Birmingham hip resurfacing).~   "
257462|NCT00180193|"~     The purpose of this study is to monitor the amino acid uptake of brain tumors, before and~     during radiotherapy, with positron emission tomography.~   "
257463|NCT00180180|"~     The purpose of this study is to describe the regional and global tumor hypoxia in~     head-and-neck cancer during percutaneous radiation therapy~   "
257464|NCT00180167|"~     Single Arm-Studies suggest improved remission and survival rates for a Protocol with~     Mitoxantron 10mg/m2 for 3 days combined with AraC 1g/m2 bid on days 1+3+5+7 compared to a~     conventional DA 7+3 protocol (45mg/m2 Daunorubicin).~   "
257465|NCT00180154|"~     The purpose of the study is to describe the regional and global FDG-kinetics in~     non-small-cell lung cancer (NSCLC) during percutaneous radiation therapy.~   "
257466|NCT00180141|"~     Atopic dermatitis is a common disease. Emollients and Elidel have both shown to be effective~     to treat this disease. The research question is, whether the effective component (Elidel) is~     better than the emollient to improve the skin function.~   "
257467|NCT00180128|"~     In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner.~     Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done~     with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone~     in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine.~     Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA~     is performed.~   "
257468|NCT00180115|"~     The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy~     including related and unrelated allogeneic stem cell transplantation for high risk AML~     patients and related allogeneic and autologous stem cell transplantation for standard risk~     AML patients in a multi-center setting. Furthermore it randomizes patients between~     intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.~   "
257469|NCT00180102|"~     AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem~     cell transplantation in aplasia after induction therapy for high risk patients with acute~     myeloid leukemia.~   "
257470|NCT00180089|"~     The purpose of this study is to determine whether orale budesonide is effective in the~     prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic~     stem cell transplantation.~   "
257471|NCT00180076|"~     The purpose of this study is to determine whether orale budesonide is effective in~     maintaining clinical remission in patients with collagenous colitis.~   "
257472|NCT00180063|"~     Characterization of an unexpected venodilative effect of higher L-NMMA-doses in dorsal human~     hand veins.~   "
257473|NCT00180050|"~     The purpose of this study is to determine whether orale budesonide is effective in the~     treatment of lymphocytic colitis~   "
257474|NCT00180037|"~     This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed~     solution in middle-stage Parkinson's disease (PD) patients (Hoehn&Yahr II to III). The~     treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo.~      The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS)~     Part II and III.~      The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased~     dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of~     parkinsonian symptoms in PD patients.~   "
257475|NCT00180024|"~     The hypothesis is tested that stimulation with angiotensin II after blockade of the~     AT1-receptor results in venodilation in human healthy subjects in vivo.~   "
257476|NCT00180011|"~     This study will be a randomized, placebo controlled, double blind study to measure the safety~     and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with~     moderate to severe asthma who are not adequately controlled with use of inhaled or oral~     steroids. Primary endpont will be change in asthma symptom utility index. Secondary endpoints~     will be changes in asthma Quality of life, asthma exacerbation rate, and lung function over~     the 12 week treatment period.~   "
257477|NCT00179998|"~     This is a study to find out whether Pulmozyme is effective for clearing mucus from the~     airways of children with cystic fibrosis less than 3 ½ years of age. Pulmozyme is given using~     a nebulizer and is now widely used in older children and adults with cystic fibrosis. In~     adults and older children, studies have shown that daily use of Pulmozyme improves lung~     function and decreases the number of lung infections requiring hospital treatment. Pulmozyme~     has been approved by the Food and Drug Administration for use in children over 5 years old~     and adults with cystic fibrosis. Pulmozyme has also been approved by the FDA for use in~     children with cystic fibrosis less than 5 years old based upon studies showing that it is~     safe in this age group and that it does get into the airway tubes as well in infants and~     toddlers as it does in older children and adults. Currently Pulmozyme is not widely used in~     children with cystic fibrosis younger than 5 years because no study has clearly shown that~     inhaling Pulmozyme daily improves lung function or improves clearance of mucus from the~     airway tubes in very young children. This study will measure whether Pulmozyme improves lung~     function and mucous clearance from the lungs in children with cystic fibrosis less than 3 ½~     years of age.~      This study will compare Pulmozyme to a placebo. During the study infants and young children~     with cystic fibrosis will be treated with Pulmozyme for 6 months and placebo for 6 months.~     The study medicines will be inhaled at home once a day from a nebulizer for a period of one~     year. Half of the children will be treated with Pulmozyme for the first 6 months of the study~     and half will receive the placebo. At the 6 month point the group receiving Pulmozyme will be~     changed to the placebo and the group receiving placebo will be changed to Pulmozyme. The~     order of the 6 month treatment periods is randomized. This study is blinded. The study doctor~     and his staff will not know who is receiving Pulmozyme or placebo at any time during the~     study.~      Whether Pulmozyme works will be measured using infant lung function tests and by doing a~     special 3-D x-ray of the child's chest (a high resolution CT or HRCT) at the beginning of the~     study, at 6 months and at 12 month after starting study. The study will not change the~     regular clinical care.~   "
257478|NCT00179985|"~     The purpose of this study is to determine whether implementing the Newborn Individualized~     Developmental Care and Assessment Program increases NICU nurses' sensitivity in meeting the~     developmental care needs of preterm infants.~   "
257479|NCT00179972|"~     The purpose of this study is to evaluate sensor longevity and skin integrity with two~     different models of neonatal pulse oximetry sensors currently used for monitoring oxygen~     levels in small infants.~   "
257507|NCT00179608|"~     This study will determine the MDT of intravenous DTIC when administered in combination with a~     fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously~     untreated with systemic chemotherapy. This study will evaluate the safety and preliminary~     efficacy of the combination of lenalidomide and DTIC. Subjects will be receive lenalidomide~     for 14 consecutive days and DTIC on day one of each 21 day cycle.~   "
260387|NCT00141401|"~     To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral~     neuropathy.~   "
257480|NCT00179959|"~     Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary~     complication of atopic dermatitis (AD), but also as a culprit in the worsening of this~     condition. In addition, the recent development of community acquired methicillin-resistant S.~     aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of~     acute infections and maintenance therapy. The investigators would like to perform a~     randomized investigator-blinded placebo-controlled study of children aged 6 months to 17~     years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial~     infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the~     relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to~     clinical response to oral cephalexin therapy and severity of the AD; and 3) whether~     concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and~     sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical~     stability.~   "
257481|NCT00179946|"~     The aim of this protocol is to clarify the role of HLA matching in unrelated umbilical cord~     blood (UCB) transplantation and to identify the level of HLA matching required assuring~     successful outcome of unrelated UCB transplantation.~   "
257482|NCT00179933|"~     The purpose of this study is to evaluate the impact of the NIDCAP program of individualized~     patient consultation on the neurobehavioral organization of transported preterm infants in~     the NICU. Behavioral response to routine caregiving will be compared between infants in the~     pre-NIDCAP group to infants in the post-NIDCAP group. And it is this behavioral response that~     will be used to evaluate the effectiveness of the NIDCAP program.~   "
257483|NCT00179920|"~     Retinoblastoma is an unusual cancer of early childhood involving tumor is both eyes or, in~     certain circumstances, one eye only. This condition is the result of an abnormal gene which~     makes both retinas (the back of the eye) vulnerable to develop multiple tumors. Growths in~     the eye impair vision temporarily or permanently. These tumors are malignant, which means~     that they can grow within the eye, spread outside of the eye, and be fatal if untreated.~      Standard therapy for bilateral retinoblastoma includes removal of one eye if vision cannot be~     save and radiation treatment of either eye in which vision might be saved. Radiation controls~     tumor growth in the majority of cases. Another standard method is cryotherapy (freezing a~     tumor to kill it). Chemotherapy (medicines used to kill tumor cells) has been used in the~     past for tumor in or outside the eye, but is not standard. Hyperthermia, increasing the~     temperature of a tumor to kill it, is widely performed, and can be done to a retinoblastoma~     tumor by a laser; this method is not standard.~      The problem with removal of an eye is that any hope of vision is lost. The problems with~     radiation include incomplete control of tumor, injury to the eye or surrounding tissue with~     decreased growth, and that (due to the abnormal retinoblastoma gene) children are very~     susceptible to develop other tumors, especially in the tissue which was given radiation.~      The doctors at Children's Memorial Hospital are using a newer form of treatment, including~     laser hyperthermia, chemotherapy and cryotherapy to decrease retinoblastoma tumors. Some may~     be controlled indefinitely, reducing the number of eyes that need radiation or removal.~      OBJECTIVES~        1. To find out how well chemotherapy plus cryotherapy and laser hyperthermia work on~          retinoblastoma tumors.~        2. To find out whether vision can be saved and tumors controlled without radiation or~          removal of the eye.~   "
257484|NCT00179907|"~     The standard treatment for children with brain tumors is surgical removal of the tumor~     followed by radiation to the brain and chemotherapy (medicines) given to shrink any remaining~     tumor or to prevent tumor from growing back. There are very few treatment options available~     for children whose brain tumor grows back after receiving radiation treatment. There is a~     greater risk of complications and side effects when the brain is repeatedly treated with~     external radiation. The side effects of repeat radiation treatment are dependent on the~     amount of the brain that is radiated. Radiation given with PRS during surgery is focused to~     the specific area of the brain where the tumor is located. Therefore, the area of the brain~     affected by the radiation is smaller. It is hoped that this targeted radiation will lessen~     the side effects to the normal brain that is not affected by the tumor. It is also hoped that~     a lower occurrence of side effects will increase the quality of life of children with brain~     tumors.~      The optimal dose of targeted radiation is not known. Therefore, increasing doses will be~     given to treat different patients, starting with the lowest possible dose. The amount of~     radiation to be given will depend on whether or not your child received prior radiation~     therapy and where the tumor is located. The groups of patients will first be divided into 2~     groups: Group A, who are those who received radiation as part of their prior treatment, and~     Group B, who are those who did not receive any radiation treatment. Each group will be then~     divided again into 2 groups depending on the location of the tumor. In each group, if the~     lowest dose is well-tolerated with only minimal side effects by 3 patients, then the next~     higher dose will be given to the next 3 patients.~      The purposes of this research are:~        -  To evaluate the potential side effects of a single high dose of x-rays using the Photon~          Radiosurgery System (PRS) given to a small area of the brain.~        -  To determine the maximum dose of targeted radiation that can be safely given to brain~          tumors with the fewest side effects.~        -  To see how well this treatment works for children with recurrent brain tumors and~          newly-diagnosed glioblastoma multiforme.~   "
257485|NCT00179894|"~     This study will determine the effectiveness of educating pediatricians about attention~     deficit hyperactivity disorder treatment guidelines in improving child behavior and~     pediatricians' adherence to medication guidelines.~   "
257486|NCT00179881|"~     Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin.~     Thalidomide has been available for many years and has been used to treat many different~     illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by~     blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have~     blood vessels providing oxygen and nutrients, it will not be able to grow. This research will~     look at how combining the effects of thalidomide (preventing tumor growth) with the tumor~     killing effect of carboplatin effects the long-term outlook for patients with these tumors.~      This study will try to find out how well Thalomid™ and carboplatin combined with radiation~     therapy works in treating children newly diagnosed with brain stem glioma. This study will~     look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem~     glioma. This study will also look at any side effects of these treatments.~   "
257487|NCT00179868|"~     The purpose of this study is to determine if C-Reactive Protein levels are predictive for~     complications post transplant.~   "
257488|NCT00179855|"~     The purpose of this research study is to evaluate the safety and feasibility of~     extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute~     graft-versus-host disease (GVHD) in children.~   "
257489|NCT00179842|"~     The investigators anticipate that this study will also form the basis to clarify further the~     role of the immune system in Crohn's disease.~   "
257490|NCT00179829|"~     The purpose of this study is to determine if WT1 is an adequate measurement of minimal~     residual disease in leukemic patients.~   "
257491|NCT00179816|"~     This study uses a double autologous peripheral blood stem cell rescue (PBSC) following~     dose-intensive chemotherapy for the treatment of high-risk pediatric solid tumors.~   "
257492|NCT00179803|"~     The primary goal of this study is to determine if a stem cell transplant in patients with~     newly diagnosed high risk CNS tumors (glioblastoma multiforme [GBM], high grade astrocytoma,~     pineoblastoma, rhabdoid tumor, supratentorial primitive neuroectodermal tumor [PNET])~     increases overall survival.~   "
257553|NCT00178984|"~     The purpose of this study is to use the Squid magnetometer (Superconducting QUantum~     Interference Device) to help diagnose electrical and mechanical abnormalities of the stomach~     and intestines.~   "
257582|NCT00178594|"~     The objective of this study will be to assess the coagulation system in-vitro in a variety of~     bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.~   "
257493|NCT00179790|"~     Stem cell transplantation may be used to cure childhood cancers, and other diseases.~     Traditionally, stem cell transplants use high doses of chemotherapy and radiation. This~     regimen may cause significant problems after transplant such as infertility, infection, and~     graft versus host disease (GVHD).~      Reduced intensity transplant (RIT) uses medications which weaken the immune system, allowing~     donor cells to take over. The goal of a RIT is to reduce the risk for complications after~     transplant. Usually medication is used to weaken the immune system, but there are other~     options such as extracorporeal photopheresis (ECP) that may be less toxic.~      ECP is currently used for the treatment of GVHD and certain lymphomas. ECP uses a machine~     that filters white blood cells from the blood, treats them with ultraviolet (UV) light, and~     then gives all the cells back to the patient. The patient's immune system becomes weaker,~     allowing the donor cells to replace those of the patient. Studies involving the use of ECP~     for conditioning have shown fewer side effects than the use of medications.~      The primary purpose of this clinical research trial is to evaluate the safety and feasibility~     of ECP as part of a preparative regimen for RIT in children and young adults.~   "
257494|NCT00179777|"~     The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) is an international effort to~     conduct a primary prevention nutrition trial for type 1 (insulin-dependent) diabetes. The~     TRIGR study is targeted at newborns who are at genetic risk for type 1 diabetes because their~     mother, father and/or full sibling has type 1 diabetes. All families are encouraged to breast~     feed their infants for as long as possible. Prior to birth, the child is randomly assigned to~     receive one of two infant formulas, should formula be required prior to 8 months of age. The~     study will determine whether weaning to a possibly protective infant formula decreases these~     children's chances of developing diabetes - as it does in the animal models for diabetes.~   "
257495|NCT00179764|"~     The purpose of this research study is to evaluate the effectiveness of transplantation of~     high doses of peripheral blood stem cells (stem cells are special cells found in the blood~     and bone marrow that produce new blood cells) after treatment with non-myeloablative~     chemotherapy (not toxic to the bone marrow). In addition, this study will assess the side~     effects of the transplant.~   "
257496|NCT00179751|"~     Phase I will determine the MDT and evaluate the safety profile of oral lenalidomide days 1-21~     and weekly gemcitabine days 1, 8, & 15 in 28 day cycles Phase II will explore the anti-tumor~     activity and safety of the combination in subjects with advanced pancreatic carcinoma.~     Subjects will receive oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, & 15 in~     28 day cycles until documented disease progression occurs.~   "
257497|NCT00179738|"~     Subjects who qualify will receive single agent oral lenalidomide daily on days 1-21 every 28~     day cycle. Subjects will continue on study until documented disease progression~   "
257498|NCT00179725|"~     Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days~     1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will~     commence once the MTD is established, additional subjects will be enrolled and receive oral~     lenalidomide on days 1-21 with liposomal doxorubicinon day 1 in 28 day cycles until disease~     progression is documented.~   "
257499|NCT00179712|"~     Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days~     1-14 when given with topotecan on days 1-5 of every 21 day cycle Phase II will commence once~     the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on~     days 1-14 with topotecan on days 1-5 in 21 day cycles until disease progression is~     documented.~   "
257500|NCT00179699|"~     Study will deteremine the MTD and evaluate the safety profile of oral lenalidomide on days~     1-14 when combined with pemetrexed on day 1 of a 21 days cycle. Subjects will continue on~     study until documention of disease progression.~   "
257501|NCT00179686|"~     Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day~     cycles. Subjects will continue until disease progression is documented.~   "
257502|NCT00179673|"~     Participants who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle.~     Treatment will continue for up to 52 weeks or until disease progression; participants who~     achieve a complete response (CR) will receive an additional 2 cycles of treatment prior to~     discontinuation. Participants will be followed for progression free survival following~     discontinuation from the treatment phase~   "
257503|NCT00179660|"~     To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.~   "
257504|NCT00179647|"~     Subjects who qualify for participation will receive lenalidomide with or without~     dexamethasone in 4 week cycles until disease progression is documented or lenalidomide~     becomes commercially available for the indication of multiple myeloma.~   "
257505|NCT00179634|"~     This is a study to assess whether healing suggestions and enhancing visual milieu (large fine~     art photographs) will improve mental and physical measures of well-being and recovery from~     surgery. The study will compare breast cancer patients undergoing identical skin sparing~     mastectomy and reconstruction surgery randomized to three groups:~        1. Usual care control group~        2. Usual care and exposure to fine art photograph~        3. Usual care and fine art photograph and guided visualization tapes.~   "
257506|NCT00179621|"~     The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of~     placebo in subjects with red blood cell (RBC) transfusion-dependent low- or~     intermediate-1-risk IPSS MDS associated with a deletion (del) 5q[31] cytogenetic abnormality.~     Study participants were randomized to one of the two treatment groups or to placebo and took~     the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid~     response. If participants did not achieve at least a minor erythroid response, they were~     discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid~     responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For~     participants that were still responding at the end of Double-Blind phase, they could then~     rollover into the Open-Label phase for an additional two years. Participants could remain on~     study for up to a total of 3 years. All participants who discontinued from the study were~     followed every 4 months for overall survival and progression to acute myeloid leukemia (AML).~   "
257607|NCT00178269|"~     The purpose of this study is to find out how effectively cervix cancer is controlled when~     radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere,~     once per week, with radiation is a new treatment for cervical cancer. This study will also~     see how well this treatment regimen can be tolerated.~   "
257508|NCT00179595|"~     The purposes of this study are:~        1. To examine molecular and biochemical changes, associated with the relaxation response~          (RR) that can counteract the effects of stress in healthy adults.~        2. To compare genomic, molecular and biochemical parameters between healthy adults with a~          long term meditative practice and those with no experience in meditation.~      Since stress is a factor in the development of many health conditions, a further~     understanding of the mechanisms of the RR should be developed. The project is designed to~     determine how the RR can improve the quality of life that has been adversely affected by~     stress.~   "
257509|NCT00179582|"~     To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS~   "
257510|NCT00179569|"~     The purpose of this study is to examine the molecular (nitric oxide) and biochemical~     (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR~     elicitation and which may counteract the effects of acute stress in the elderly.~   "
257511|NCT00179556|"~     Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of~     life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy~     for hot flashes. The study examines the effect of a new soy supplement, as compared to a~     placebo, in menopausal women on hot flash symptoms.~   "
257512|NCT00179543|"~     The purpose of this study is to determine whether the relaxation response is more effective~     than attention control in reducing blood pressure and medication dosage in elderly adults~     with isolated systolic hypertension.~   "
257513|NCT00179530|"~     To evaluate whether a 5-week relaxation response intervention influences the learning, memory~     or attention of healthy older adults.~   "
257514|NCT00179517|"~     The purpose of this study is to determine if treatment using a medication~     (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a~     tablet that does not contain any active medication, when combined with testosterone~     replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole,~     the medication that is currently under study, does not, at this time, have FDA approval for~     use for this indication.~   "
257515|NCT00179504|"~     Stress contributes to health and behavioral issues in students, but will not be integrated~     into schools without evidence of benefit. This study was conducted to determine if a 6-week~     relaxation response (RR) curriculum improves cognitive performance in ninth grade students.~   "
257516|NCT00179491|"~     Intercessory prayer is widely believed to influence recovery from illness, but claims of~     benefits are not supported by well-controlled clinical trials. Prior studies have not~     addressed whether prayer itself or knowledge/certainty that prayer is being provided may~     influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being~     certain of receiving intercessory prayer was associated with uncomplicated recovery after~     coronary artery bypass graft (CABG) surgery.~   "
257517|NCT00179478|"~     The current study is a continuation of the 5 year extension study of the phase III CHAMPS~     study (see reference). This study was designed to determine if immediate initiation of~     therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS)~     continues to delay the development of further attacks (CDMS) and the development of~     neurological disability over a 10 year period of observation. The initial 5 year extension~     study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX)~     after a first attack of MS continued to delay the development of CDMS and lowered relapse~     rates compared to delayed initiation of disease modifying treatment (usually with AVONEX)~     either at the time of a second attack or at the end of the phase III study (24 months). The~     study was extended to 10 years to determine if these effects are sustained and result in less~     long term permanent disability.~   "
257518|NCT00179465|"~     The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during~     the early course of schizophrenia can fundamentally correct the brain deficits associated~     with the disease.~      This study is funded by the National Institutes of Health.~   "
257519|NCT00179452|"~     To establish the safety and feasibility of having patients with epilepsy perform yoga.~   "
257520|NCT00179439|"~     The investigators hypothesize that PSC in children is associated with mutations and~     functional changes of the cystic fibrosis (CF) gene.~   "
257521|NCT00179426|"~     The purpose of this study is to determine if antiseizure drugs affect hormone levels and~     sexual function in men with seizures.~   "
257522|NCT00179413|"~     In this study Peg-Intron will be tested to see if it will give better results than~     Colchicine. At this time, there is currently no recommended maintenance treatment for~     patients who have failed to respond to Interferon/Rebetron/Peg Intron and have advanced~     fibrosis. The purpose of this study is to compare two treatments to slow down the progression~     of liver disease and to prevent liver failure and liver cancer. The treatment will not cure~     Hepatitis C, but is being evaluated to see if it can slow down disease progression.~   "
257523|NCT00179400|"~     Doctors are studying natural oils as potential therapies for type 2 diabetes. Animal studies~     have suggested promising results using EPA (found in fish oils) to improve insulin action and~     lower blood sugar levels.~   "
257524|NCT00179387|"~     The purpose of this study is to find out if Mind-Body groups can help improve the physical~     and emotional well-being of people facing cancer or its treatment.~   "
257525|NCT00179374|"~     This study has the following specific aims:~        1. A tailored telephone intervention will significantly improve medication adherence~          compared to a standard care intervention.~        2. A tailored telephone intervention will significantly improve metabolic control measured~          by HbA1c compared to a standard care intervention 2a) We will explore ways to link~          behavior change for medication adherence with lifestyle modification for diet and~          physical activity.~        3. To conduct cost evaluations for the telephone intervention vs. standard care.~   "
257554|NCT00178971|"~     Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who~     have been treated with antipsychotic medications. Patients will be assigned to take active~     medication (Buspar)or placebo along with their prescribed antipsychotic medication for six~     weeks. Patients' memory and problem-solving ability will be tested before and after~     medication.~   "
257555|NCT00178958|"~     The aim of this study is to evaluate the utility of continuous Holter ECG recording with~     automated, computerized data analysis for measuring antipsychotic-related QTc prolongation~     during a 24-h period under clinical conditions~   "
257526|NCT00179361|"~     Oro-pharyngeal cancers can develop from squamous dysplastic precursor lesions, which occur in~     a subset of common white (leukoplakia), red (erythroplasia), or mixed oro-pharyngeal plaques.~     Known risk factors for oro-pharyngeal cancer include tobacco smoke, alcohol consumption, diet~     and, in a subset of tumors, human papillomavirus (HPV). Along the oro-pharyngeal disease~     continuum, there may be variations in gene expression precursor lesions as a result of~     exposure to smoking, alcohol and HPV. However, the components of gene expression that are~     most likely associated with tumorigenesis in these tissues are poorly understood. This study~     will focus upon early gene expression profiles in the oral cavity and oropharynx in subjects~     who have precursor lesions and have been exposed to the common risk factors for carcinoma~     development including smoking and HPV infection. This application is to conduct pilot testing~     and establish appropriate procedures for an international prospective cohort study of the~     natural history of oro-pharyngeal cancer precursors among men and women at high risk of~     oro-pharyngeal cancer at Montefiore Medical Center, Bronx-NY. Brush biopsy specimens will be~     used to collect a transepithelial sample of cells from oro-pharyngeal plaques, as well as~     normal tissue from defined regions of the oral and pharyngeal mucosa. Measurement of gene~     expression will employ novel high-throughput cDNA microarray analysis and PCR-based HPV DNA~     testing. Oro-pharyngeal dysplasia will be diagnosed using cytopathology. Under this~     application, we will assess our planned instruments and procedures on an initial sample of 40~     subjects. This planning period will allow for precise identification of methodologies,~     standardization of instruments and assays to be utilized by additional participating centers~     in a subsequent application.~   "
257527|NCT00179348|"~     This clinical trial studies yoga-based rehabilitation in reducing physical and emotional side~     effects of living with cancer or its treatment. Yoga-based rehabilitation may reduce side~     effects and improve the quality of life of patients with breast, lung, or colorectal cancer.~   "
257528|NCT00179335|"~     HIV infected patients, aged </= 35 years and aged >/= 55 years, who are regularly taking~     either efavirenz (EFV) or lopinavir/ritonavir (Lop/r) as part of their antiretroviral regimen~     are being asked to spend 12 hours at the researchers' clinic (the ACS clinic at Jacobi~     Medical Center, Bronx, New York) for an intensive pharmacokinetic study in which 5 cc of~     blood will be drawn 9 times over a 12 hour period. Patients taking EFV will return for one~     additional blood draw the following day.~   "
257529|NCT00179322|"~     This study will measure brain activity in individuals performing language tasks while in~     various states of alertness to learn more about how the central nervous system is affected by~     impairments such as sleepiness.~      Healthy normal volunteers between 20 and 40 years of age may be eligible for this study.~     Candidates must be non-smokers, right-handed, speak English fluently and have at least 12~     years of education. They are screened with a medical history, physical examination, hearing~     and speech evaluation, computer task training, blood and urine tests and a late-night~     functional magnetic resonance imaging (fMRI) scan (see description below). Before screening~     and again before participating in the study, candidates wear an actigraph (a wristwatch-like~     device that records motion) for 7 days to provide a measure of their sleep-wake patterns.~      Participants undergo the following tests and procedures:~        -  Extended wakefulness: Subjects are kept awake longer than is normal for them in their~          everyday life to be able to examine the brain under conditions of sleepiness. They are~          engaged in activities with the research staff during this waking time.~        -  Functional magnetic resonance imaging: Subjects undergo five separate fMRI scans-one~          during screening and four others during the main part of the study. fMRI uses a magnetic~          field and radio waves to produce images of the brain. The subject lies on a table that~          is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking~          and thumping sounds that occur during the scanning process. Brain scans are taken at~          rest and while the subject performs tasks, which include pressing a button upon seeing~          certain shapes and performing various language tasks, such as saying memorized or new~          words, listening to narratives, and describing everyday procedures.~        -  Neurological, speech-language, and neuropsychological testing: Before the fMRI exams and~          during the period of extended wakefulness, subjects complete a series of tests that~          measure speech, language, memory and visual skills. Portions of the tests may be video-~          or autiotaped.~        -  Interviews and questionnaires: Participants are interviewed about their handedness,~          sleep history, and presence of medical or neurological symptoms.~        -  Electrophysiological studies: Subjects have an electroencephalograph (EEG) to measure~          the electrical activity of the brain and surface electromyography (EMG) to measure~          movements of muscles involved in moving and speaking. For the EEG, electrodes (small~          metal disks) are attached to the surface of the scalp or to a cap placed over the head.~          For the EMG, electrodes are attached to the skin of the face and neck by plastic or~          paper tape.~   "
257530|NCT00179309|"~     This study will test whether giving a combination of a vaccine together with docetaxel is~     more effective against breast cancer than docetaxel alone. The Food and Drug Administration~     has approved docetaxel to treat many cancers, including breast cancer. The vaccine consists~     of three parts: 1) a priming vaccine called PANVAC (PAN (all) VAC (vaccine)) trademark~     [TM]-V, which is made from vaccinia virus; 2) a boosting vaccine called PANVAC[TM]-F, made~     from fowlpox virus; and 3) sargramostim, or granulocyte macrophage colony stimulating factor~     (GM-CSF), a protein that may help boost the immune system. Human genes are inserted into the~     vaccinia and fowlpox viruses to cause production of carcinoembryonic antigen (CEA) and mucin~     1 (MUC-1)-two proteins that are often produced by cancer cells and can be used as a target~     for the immune system to attack the cancer. Another type of deoxyribonucleic acid (DNA) is~     inserted to cause production of other proteins that enhance immune activity.~      Patients 18 years of age or older with metastatic breast cancer (disease that has spread~     beyond the original site) and whose cancer produces CEA or mucin 1 (MUC-1) protein may be~     eligible for this study. Patients must have antigen type human leukocyte antigen A2 (HLA-A2).~     They may have received adjuvant docetaxel treatment at least 3 months before entering this~     study, prior hormonal therapy and up to three chemotherapy regimens. Candidates are screened~     with a medical history and physical examination, blood and urine tests, electrocardiogram,~     and computerized tomography (CT) or magnetic resonance imaging scans.~      Participants are randomly assigned to one of two treatment groups - docetaxel alone or~     docetaxel plus vaccine - as follows:~      Docetaxel Alone~      All patients receive docetaxel. The drug is infused through a vein over 30 to 60 minutes once~     a week for 3 consecutive weeks with 1 week off drug. Patients also take dexamethasone 12~     hours and 1 hour before and 12 hours after the docetaxel to help prevent fluid retention~     (edema) that docetaxel may cause.~      Docetaxel Plus Vaccine~      Participants receive the priming vaccination followed by monthly boosting vaccinations, along~     with the weekly docetaxel therapy. With every vaccination, patients also receive an injection~     of sargramostim to increase the number of immune cells at the vaccination site. Sargramostim~     injections are given the day of vaccination and daily for the next 3 days. All vaccine and~     sargramostim doses are given as injections under the skin, usually in the thigh. Patients are~     observed in the clinic for 1 hour after each injection.~      Patients have blood tests every four weeks to monitor drug side effects and before every~     vaccination to check blood counts. A bone scan or CT scan (or both) is done every 2 to 3~     months to check the response to treatment.~      Patients may continue receiving treatment as long as their disease does not worsen and they~     can tolerate the treatment without significant side effects. Patients assigned to receive~     docetaxel alone whose disease progresses after 3 months on the drug may choose to receive the~     vaccine or come off the study to receive other treatment options. Patients are monitored with~     yearly telephone calls for up to 15 years.~   "
257531|NCT00179283|"~     This is a randomized, double-blind, active control, 8-week, flexible dose study of sertraline~     vs. venlafaxine Extended Release in the acute treatment of Major Depression in male and~     female outpatient sites that will recruit 15-20 patients each. Subjects will be randomized in~     a 1:1 ratio to receive either sertraline or venlafaxine XR based on a computer-generated~     randomized list.~   "
257532|NCT00179257|"~     The purpose of this is to determine the efficacy, safety, and tolerability of sertraline in~     patients with major depressive disorder (MDD) who have shown inadequate response ot~     escitalopram.~   "
257533|NCT00179244|"~     The purpose of this study is to evaluate the comparative effectiveness of Risperdal~     (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test~     the relative safety of the combinations.~   "
257534|NCT00179231|"~     The study involves a six-month, double-blind protocol during which eighty patients, across~     three sites around the country, will be randomly assigned to receive clozapine or olanzapine.~     The specific aims of the study are to evaluate the relative effects of olanzapine and~     clozapine on clinical outcomes and cognition in patients diagnosed with schizophrenia or~     schizoaffective disorder who have demonstrated resistance to treatment in the past.~   "
257535|NCT00179218|"~     The objective of this study is to determine how protein supplementation, with or without~     exercise, affects functional capacity, strength, body composition, and physical activity in~     hemodialysis patients.~   "
257536|NCT00179205|"~     In this study, the investigators hypothesize that long-term administration of adequate~     intradialytic oral nutritional supplementation will increase visceral protein concentrations~     and somatic protein stores in malnourished chronic hemodialysis patients.~   "
257551|NCT00179010|"~     Adenosine and AMP are substances normally present in the body. Adenosine is also given for~     the treatment of some heart rhythm problems and may be used to reduce heart damage during~     heart attacks. The problem in using adenosine is that it is taken up by cells and, therefore,~     very little of the adenosine we give by vein or in the artery actually reaches the tissue. We~     propose to use AMP as a way to improve delivery of adenosine. AMP is inactive by itself, but~     is converted to adenosine in tissue. We hope that by giving AMP we will increase levels of~     adenosine in tissue. To see if this is true, we will give either adenosine or AMP into the~     forearm artery while we measure how much adenosine reaches the forearm tissue.~   "
260388|NCT00141388|"~     To evaluate the long-term safety and efficacy of pregabalin in patients with partial~     seizures.~   "
257537|NCT00179192|"~     Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the~     largest single cause of morbidity in the chronic hemodialysis population, accounting for over~     25% of hospitalizations at an estimated cost in the US of at least one billion dollars~     annually. Currently, complication free survival of vascular access ranges between 30-50% a~     year and multiple investigative efforts in this area have been initiated and are directed at~     prolonging the functional life of vascular accesses.~      It is not well established whether intervention prior to overt malfunction or thrombosis of~     the vascular access could reduce these complications and thereby improve the functional~     longevity of the access. Moreover, once accesses at potential risk are identified, it is not~     well established which method of intervention, Surgery vs. Angioplasty vs. Expectant~     Management, is superior in terms of clinical and financial outcome. The proposed study aims~     to determine whether early intervention of a vascular access determined to be at risk of~     malfunction and thrombosis improves the long term outcome and, specifically, which means of~     intervention is preferred.~   "
257538|NCT00179179|"~     To test the hypothesis that an exercise session combined with adequate nutritional~     supplementation improves skeletal muscle protein accretion during a hemodialysis session.~   "
257539|NCT00179166|"~     We hypothesize that a nutritional supplementation with higher than standard protein content~     (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when~     administered to critically ill patients with acute renal failure (ARF).~   "
257540|NCT00179153|"~     We propose to identify malnourished chronic kidney dialysis patients through a statewide~     effort and subsequently treat them based on a protocol (provision of oral nutritional~     supplementation) over a period of six (6) months.~   "
257541|NCT00179140|"~     The objective of this study is to determine how protein supplementation, with or without~     exercise, affects functional capacity, strength, body composition, and physical activity in~     hemodialysis patients.~   "
257542|NCT00179127|"~     The purpose of this study is to determine the effects of the addition of insulin glargine~     during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.~      The investigators hypothesize that the addition of insulin glargine during the early phase of~     management of DKA will accelerate acidosis correction, decrease the length of insulin~     infusion, and decrease the total intensive care unit time in children admitted to the ICU.~   "
257543|NCT00179114|"~     People with severe developmental disabilities frequently have comorbidities that make~     providing care to them more difficult. Spasticity is one such comorbidity. It produces~     increased muscle tone that can cause stiffness in joints and bodily contortions that can~     interfere with all of the major types of care provided to participants. Typically, care areas~     include splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in~     other functional activities. Moreover, persons with spasticity often experience pain.~      Typically, spasticity is managed by health care providers using a combination of the~     following therapies:~        -  Physical / occupational therapy (PT / OT)~        -  Oral medication~        -  Botox injections~        -  Intrathecal baclofen administered by the Medtronic SyncroMed pump (ITB)~        -  Orthopedic / neurological surgery~   "
257544|NCT00179101|"~     We will evaluate the effect of deep brain stimulation on the depression and quality of life~     in Parkinson’s disease. We aim to compare depression pre-operatively and post-operatively in~     Parkinson’s patients with deep brain stimulation to Parkinson’s patients evaluated and~     approved for deep brain stimulation but who did not complete surgery. We will also compare~     quality of life measures between patients with and without deep brain stimulation.~   "
257545|NCT00179088|"~     The purpose of this study is to determine if full weight bearing following total hip~     replacement can speed recovery when the hip replacement in the long bone of the leg is not~     cemented into the bone. When cement is used, most surgeons allow full or nearly full weight~     bearing following hip replacement. One drawback to cementless implants has been the~     restriction of weight bearing for six to eight weeks after surgery, during which time~     patients are allowed to only put their foot flat on the floor of the operated leg without~     bearing weight on that leg. This study compares the effect of immediate weight bearing on the~     speed of recovery from hip replacement surgery in two groups of patients receiving a~     non-cemented total hip replacement: one group is randomly assigned to not bear weight, and~     the other group is randomly assigned to allowed, tolerated weight bearing from the day of~     surgery forward.~   "
257546|NCT00179075|"~     This is a repository to store blood and stem cell samples for future research.~   "
257547|NCT00179062|"~     This twelve month, open-label study considers the effect of Risperdal (risperidone) versus~     Zyprexa (olanzapine) on weight gain, physical health, and outcome in a population of those~     diagnosed with schizophrenia, schizoaffective disorder, major depression or bipolar disorder~     with psychotic features. This study evaluates symptom response as well as general health~     indicators such as body mass index, glucose, prolactin, and cholesterol levels at baseline,~     month (M)1, M3, M6 and M12.~   "
257548|NCT00179049|"~     The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while~     minimizing the complications of graft-versus-host disease.~   "
257549|NCT00179036|"~     The lack of blood flow to the small intestine causes mesenteric ischemia. Using a~     Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the~     small intestine, we are hoping to identify abnormalities without surgical intervention.~   "
257550|NCT00179023|"~     In its simplest terms, obesity is the results of a positive balance between food intake and~     energy expenditure (EE). I.e., we take in more energy, in the form of food, than we expend,~     e.g., by exercise. In our sedentary society, resting EE accounts for most of total energy~     expenditure. The sympathetic nervous system (SNS, the one that produces adrenaline) is~     thought to contribute to resting EE. This conclusion is based on experiments where resting EE~     is decreased by beta-blockers, high blood pressure medicines that block only one aspect of~     the sympathetic nervous system. The investigators propose to use a different approach, by~     using a medication called trimethaphan that produces transient withdrawal of the autonomic~     nervous system. The investigators will then compare the measured resting EE before and after~     SNS withdraw and quantify the degree of contribution to the resting EE by the SNS and~     delineate differences between healthy normal, healthy obese, and patients with autonomic~     dysfunctions.~   "
260389|NCT00141375|"~     To evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain~     after spinal cord injury.~   "
257556|NCT00178945|"~     The purpose of this study is to investigate the use of injections of Botox (botulinum toxin~     type A) for the treatment of chronic neck pain. Botox is an approved treatment for patients~     with cervical dystonia. Cervical dystonia is a chronic condition characterized by involuntary~     movements of the neck that are often painful. In this study, the response from Botox in~     patients with neck pain not associated with cervical dystonia will be compared to the pain~     response in patients with cervical dystonia.~   "
257557|NCT00178932|"~     The goals of this study are to replicate previous findings of genetic predictors of response~     to clozapine and other antipsychotic drugs.~   "
257558|NCT00178919|"~     The amount of blood flowing to the different parts of the body is regulated by the autonomic~     (automatic) nerves and by local factors produced by the blood vessels. Nitric oxide (NO) is~     one of the most important of these metabolic factors. If the production of NO is slowed or~     stopped the amount of blood to the different parts of the body is decreased. There is~     increasing knowledge that NO mechanisms are impaired in a number of medical conditions. NO~     function is reduced in patients with risk factors for atherosclerosis (hardening of the~     arteries) such as hypercholesterolemia (patients with high cholesterol), or diabetes~     mellitus, and is also impaired in smokers. This NO deficiency is believed to contribute to~     the greater cardiovascular risk that marks these patient populations. This study is designed~     to examine if endothelial nitric oxide is an important control mechanism of blood pressure~     under normal conditions, and if impairment of nitric oxide contributes to hypertension.~   "
257559|NCT00178906|"~     This project is focused on acoustical, sound, analysis of speech in order to identify vocal~     characteristics of speech that are associated with suicidality. Speech samples will be~     collected from four populations with different mental health status: suicidal, ideational~     suicidal, depressed and those in remission from depression, (the control group). Speech of~     subjects will be recorded during routine diagnostic interview sessions. The speech samples~     will be acoustically analyzed via digital computer algorithms. The acoustical differences~     among those groups will be determined based on the statistical analysis.~   "
257560|NCT00178893|"~     This is a registry of human hepatocytes (liver cells) for research purposes.~   "
257561|NCT00178880|"~     The purpose of the study is to identify and understand patterns of brain activity when people~     are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI)~     which does not involve any exposure to radioactivity or radioactive substances.~   "
257562|NCT00178867|"~     A registry of patients with the diagnosis of hepatocellular carcinoma.~   "
257563|NCT00178854|"~     This is a study of the chemistry of depression in people who are taking an antidepressant but~     it is not working well. The changes in brain chemicals that occur when an SSRI type~     antidepressant is supplemented with risperidone (Risperdal®) will be studied. Spinal fluid is~     used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be~     involved in depression. The study has potential to help understand and treat depression.~   "
257564|NCT00178841|"~     The purpose of this trial is to determine if combination therapy with rosiglitazone and~     bexarotene might have a synergistic effect in the treatment of patients with CTCL.~   "
257565|NCT00178828|"~     The purpose of this study is to understand changes in brain chemical signals when people take~     antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal~     fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought~     to be involved in depression. The study has potential to help understand and treat~     depression.~   "
257566|NCT00178802|"~     Thermal therapy (hyperthermia of heat) can increase the effect of chemotherapy treatments. By~     itself, thermal therapy can also kill cancer cells. By using thermal therapy to treat the~     whole body, the investigators can treat cancer cells wherever they are throughout the entire~     body. In this study, the investigators are testing the combination of thermal therapy~     combined with chemotherapy to see:~        1. if it improves the effect of the chemotherapy drugs,~        2. if it helps the body fight the cancer cells, and~        3. if this treatment is safe for the patient.~      This study does not offer heat treatment alone. Any patient with advanced or metastatic~     breast, or endometrial cancer resistant to standard treatment may be treated with the phase~     II protocol therapy; however, the patient will need to undergo some medical tests to make~     sure this treatment would be safe for them.~   "
257567|NCT00178789|"~     Currently, most emergency physicians have limited access to obtaining formal radiology~     ultrasound studies, particularly overnight. Many are forced to adopt risky and expensive~     strategies in managing their patients with suspected deep venous thrombosis (DVT) who present~     during off-hours: for low risk patients, discharging without anticoagulation and arranging~     for outpatient studies; for moderate to high risk patients, empirically anticoagulating and~     admitting to the hospital to await definitive testing. If emergency physicians could reliably~     perform an accurate ultrasound exam for DVT, such risks could be obviated.~      This is a prospective, observational cohort study assessing the accuracy of emergency~     physician diagnosis of proximal DVT using compact ultrasound equipment and a simplified~     compression technique. The value of color flow doppler and augmentation will also be~     assessed. Outcomes (sensitivity, specificity, positive likelihood ratio and negative~     likelihood ratio) will be assessed at 30 days.~      Prior to enrolling patients in the study, emergency physicians will undertake a 2 hour~     training course on the performance of the simplified compression technique for the diagnosis~     of lower extremity DVT. Emergency physicians will perform the DVT ultrasound exam on study~     subjects with suspected DVT. Clinical management of the study subjects will not be altered;~     all subjects will proceed to receive a formal DVT ultrasound study by the radiology~     department which will serve as the criterion reference for the study.~   "
257568|NCT00178776|"~     The purpose of this study is to determine the feasibility and promise of a recently~     manualized group therapy based on the Transtheoretical Model for cocaine use disorders.~   "
257580|NCT00178620|"~     The PATCAR study has been designed to test the hypothesis that the strategy of pre-hospital~     use of a clot busting (thrombolytic) drug followed with emergent heart catheterization~     including stenting of the problematic coronary artery, will result in a lower mortality and~     reduced repeat heart attack rates.~      Early identifying and treating heart attacks patients prior to the arriving at the hospital,~     in those patients who qualify for the clot busting drugs will lower the size of the heart~     attack damage. This smaller heart attack will lead to fewer problems with less repeat heart~     attacks and death in the future.~   "
257569|NCT00178763|"~     Thermal therapy (hyperthermia, or heat) enhances the chemotherapy anti-tumor kill. Thermal~     therapy by itself also kills cancer cells. Whole-body thermotherapy is a systemic treatment~     that includes the entire body. By using fever-range whole-body thermal therapy, cancer cells~     can be treated wherever they are throughout the entire body. In this study, we are testing a~     combination of fever-range thermal therapy combined with chemotherapy to test: 1) the~     response of metastatic or advanced pancreas cancer to the combined modality treatment of~     thermotherapy and selected chemotherapy; 2) whether it helps the body immunity fight the~     pancreas cancer; and 3) if this treatment is safe for the patient.~      This study does not offer thermal therapy alone. Any patient with measurable, inoperable or~     metastatic pancreatic cancer may be treated; however, the they will need to undergo specific~     medical tests to make sure this treatment would be safe for them.~      We hypothesize that a combined-modality therapy using fever-range whole-body hyperthermia~     (FR-WBH; temperature = 40 o C; duration = 6 h), administered in an optimized time/sequence~     schedule with cisplatin, gemcitabine HCl (gemcitabine), and metronomically administered,~     low-dose interferon-alpha (IFN-alpha) to patients with inoperable or metastatic pancreas~     cancer, will, without inducing intolerable toxicity: a.) decrease the pancreatic cancer size;~     b.) improve quality of life; c.) enhance the immune response against the cancer; d.) increase~     survival; and e.) allow inoperable pancreatic cancer to be converted to operable disease.~   "
257570|NCT00178750|"~     The purpose of this study is to compare how well the CompuFlo® computerized syringe pump~     works as compared to the traditional method of inserting an epidural (a needle placed in~     one's back to give pain medicine).~   "
257571|NCT00178737|"~     In this research we propose to develop a comprehensive model to explain how users process~     persuasive messages. We then propose to experimentally test varying the persuasiveness of~     message content in various domains, and assess their impact on adherence by both physicians~     and patients. Finally based on our conceptual model and results from the experimental data we~     propose to develop preliminary guidelines to assist developers in designing effective~     messages.~   "
257572|NCT00178724|"~     The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting~     de-identified data from patients admitted through the Emergency Department of a NACTN center~     at the time of injury with an initial (first time) spinal cord injury (SCI). Information will~     be collected on the natural history of SCI and course of treatment through the first 12~     months from the date of injury or long as medically indicated. Data collected includes~     imaging information from CT or MRI scans, neurological and general medical outcome and~     rehabilitation evaluation. No intervention is given other than standard of care for spinal~     cord injury, intensive monitoring and frequent follow up care.~   "
257573|NCT00178711|"~     Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury,~     reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will~     result in an increased number of patients with good outcomes at six months after injury~     compared to patients randomized to normothermia.~   "
257574|NCT00178698|"~     Thermal therapy (hyperthermia, or heat) increases chemotherapy cancer cell kill. By itself,~     thermal therapy can also kill cancer cells. Whole body thermal therapy is a systemic~     treatment; whole-body fever-range thermal therapy can safely treat cancer cells wherever they~     are throughout the entire body. In this study, we are testing the combination of fever-range~     heat treatment and chemotherapy to test 1) The response of three types of cancer (small-cell~     lung, neuroendocrine cancer, lung cancer, and gastric cancer) to the thermo-chemotherapy~     improves cancer response compared to the effect of only chemotherapy drugs in current use; 2)~     whether the thermo-chemotherapy treatment helps the person's own body fight the cancer cells;~     and 3) whether this treatment is safe and comfortable for the patient. This study does not~     offer heat treatment alone. Any patient with inoperable or metastatic small cell lung cancer,~     neuroendocrine cancer (any organ), gastric cancer, or lung cancer, can be treated with the~     Phase II protocol therapy; however, the patient will need to undergo selected medical tests~     to make sure this treatment would be safe for them.~   "
257575|NCT00178685|"~     These two studies will examine the role of autonomous motivation in maintained adherence. The~     first study will determine whether smokers are still abstinent from tobacco 32 months after~     starting in a previous project (Smoker's Health Study). The purpose of the second study is to~     determine which of three treatments for tobacco dependence provides the greatest amount of~     protection from relapsing to smoking after quitting. Specifically, the investigators will~     determine if extending the length of treatment time focusing on relapse prevention and~     arranging for support from important others prevents relapse compared to community care.~     Also, the investigators will determine if providing extended treatment time and support from~     important others plus providing medications to those that don't want to quit prevents long~     term relapse compared to just extending the length of treatment time and support from others.~     Additionally, a sub set of the population will be randomized to using hand held palm devices~     to recover real-time data assessment during the last 10 months of the project.~   "
257576|NCT00178672|"~     The primary objective of this study is to assess the safety and effectiveness of stenting in~     the treatment of obstructive carotid artery disease. Secondary objectives are the assessment~     and standardization of optimal operator techniques and successful deployment and retrieval of~     the AngioGuard XP Distal Protection Device. This is a single center, prospective, open-label~     feasibility study. The study population will consist of patients with atherosclerotic~     obstructive or post-endarterectomy restenotic lesions in native carotid arteries. The~     intention is to include patients with both types of lesions.~   "
257577|NCT00178659|"~     The specific aim of this research is to determine if the blood from brain-injured patients~     contains reproducible protein markers that appear prior to elevations in intracranial~     pressure (ICP).~   "
257578|NCT00178646|"~     The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating~     muscle tightness and spasms in the feet and ankles of people with stroke.~   "
257579|NCT00178633|"~     An original cohort of 43 patients were recruited for analysis of anthropometrics, metabolic~     profile, skeletal muscle biopsy, echocardiogram at baseline, 3 months and 9 months post~     bariatric surgery. While all 43 patients reportedly completed 3 and 9 month evaluations, only~     15 patients completed 24 month evaluations due to 28 patients unwilling to return.~      The overarching purpose appears to have been not only evaluation of weightloss, but~     normalization of metabolic profile over time.~   "
257583|NCT00178581|"~     Glutamine is considered a conditionally essential amino acid during critical illness. After~     severe trauma, glutamine supplementation into the gastrointestinal tract may help maintain~     bowel function. We hypothesize that for the major torso trauma patient, high dose glutamine~     given enterally during resuscitation from shock and continued during enteral nutrition~     support is absorbed, available systemically and preserves gut integrity.~   "
257584|NCT00178568|"~     People under stress, such as those caring for an ill family member, often have trouble with~     their sleep. The aim of this study is to see if reducing stress and changing a caregiver's~     sleep and wake patterns will improve his/her sleep. The investigators also will see whether~     improvements in sleep result in improved mood, health, and general functioning.~   "
257585|NCT00178555|"~     The purpose of this study is to determine if the Video Laryngoscope (VL) is a useful~     instrument in patients at risk for difficult intubation. We will compare this device to the~     traditional Macintosh Laryngoscope.~   "
257586|NCT00178542|"~     The primary objective of this study is to describe characteristics and trends for thrombin~     generation (TG) and thromboelastography (TEG) at 4 time points during the menstrual cycle.~   "
257587|NCT00178529|"~     This is an interdisciplinary, intervention study with stroke survivors and their spousal~     caregivers after discharge from a rehabilitation unit. It will determine whether couples~     receiving home visits from nurses and therapists over a 6 month period demonstrate better~     function and less psychological distress than couples who receive information by mail. All~     couples are visited every 3 months by a nurse who assesses their physical and psychosocial~     functioning.~   "
257588|NCT00178516|"~     The goal of this study is to determine whether there is a correlation between the levels of~     Vitamin E in sperm and sperm DNA fragmentation.~      Previous research has shown that damage to the DNA in sperm may cause infertility or increase~     the chances of miscarriage, if the damage is extensive (eg. present in the overwhelming~     majority of sperm). Some studies suggest that DNA damage can be caused by oxidative stress.~     Antioxidants, such as Vitamin E, which are present in some foods, can prevent damage to cells~     from free radicals, which are naturally present by-products of metabolism. We ask whether~     there is a correlation between sperm DNA damage and Vitamin E~   "
257589|NCT00178503|"~     This study examined the cognitive and behavioral differences in children who have an autism~     spectrum disorder (ASD) with or without additional symptoms of ADHD. The study also examined~     the effectiveness of a range of doses of methylphenidate in improving cognitive and~     behavioral outcomes in children with both ASD and ADHD.~   "
257590|NCT00178490|"~     High blood pressure, or hypertension, affects up to 10% of minority children and adolescents.~     Although complications of high blood pressure, such as stroke and heart attack, are uncommon~     in childhood, high blood pressure-related organ damage can occur at a young age. Studies with~     young adults have indicated that high blood pressure can affect the central nervous system,~     resulting in deficits in brain function. However, more research is necessary to confirm the~     association between neurocognitive deficits and high blood pressure in children and to~     determine if these deficits are reversible with treatment. This study will determine whether~     high blood pressure in children and adolescents has subtle effects on learning, attention,~     and concentration. The study will also determine the effect of an antihypertensive treatment~     plan, involving a combination of diet, weight loss, increased exercise, and if needed, blood~     pressure medication, on brain function in children and adolescents receiving treatment for~     high blood pressure.~   "
257591|NCT00178477|"~     The purpose of this research study is to evaluate typical tumor motion caused by breathing~     using MRI and can help determine whether simple passive breathing and/or breath-holding could~     be used for the future treatment of similar lung and liver tumors using radiation therapy~     radiosurgery techniques.~   "
257592|NCT00178464|"~     Neurologic complications secondary to cerebrovascular damage are prevalent in children with~     sickle cell disease. These patients experience both clinically overt cerebrovascular~     accidents and silent infarctions demonstrated by magnetic resonance imaging (MRI). They are~     also at risk for neurocognitive abnormalities.We hypothesize that daily, low-dose aspirin~     therapy will safely diminish the incidence and progression of cognitive deficits as well as~     the predisposition to overt and silent stroke in children with homozygous sickle cell disease~     (Hgb SS) or hemoglobin S Beta Zero Thalassemia (Hgb SB-0 Thal). In order to optimize the~     design of a future trial to test this hypothesis, we propose a pilot study to test the safety~     and tolerability of aspirin in young children with sickle cell disease.~   "
257593|NCT00178451|"~     In the first portion of the study, the goal will be to determine the safety of the drug~     Abciximab for use during and in the period after open carotid artery surgery. In addition,~     using specialized ultrasound equipment (a probe that is placed on the outside of your skin of~     your head), we will aim to measure the number of particles released around the time of~     surgery while being treated with Abciximab. The second phase of the study will be determine~     if Abciximab can safely reduce the number of particles released into the bloodstream around~     the time of surgery in order to reduce the risk of stroke.~   "
257594|NCT00178438|"~     The purpose of this study is to determine the best role for capsule endoscopy in diagnosing~     Crohn's disease.~   "
257595|NCT00178425|"~     The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the~     blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based~     on body weight. While the deceased donor transplant receives the complete liver, in the live~     donor just over half of the liver is given (about 60%). The way these different types of~     transplants break down drugs could be different. Measuring the drug levels allows us to know~     what happens to the medication in between the morning and the evening dose.~   "
257608|NCT00178256|"~     A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in~     which patients with non-small cell lung cancer will be treated with radiation therapy and a~     drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first~     purpose of this study is to determine the dose of paclitaxel which, when given in combination~     with radiation therapy, will provide the greatest effect have the least side effects. To~     determine this, patients will be put on the study in groups of 3. The dose for each~     additional group will be higher than the previous dose until the maximum tolerated dose is~     reached. The second purpose is to determine if radiation therapy with paclitaxel is more~     effective in treating lung cancer than radiation therapy alone.~   "
257596|NCT00178412|"~     In this study, an intervention is tested that is designed to improve the outcomes of~     hospitalized elders and family caregivers.~      Study design:~        -  randomized, controlled study~        -  participants: 280 family caregivers aged 21 or above~        -  length of follow-up: 2 weeks and 2 months after hospitalization~      Study hypothesis: In this randomized clinical trial, the following hypotheses will be tested:~        1. Hospitalized elders whose family CGs receive the CARE program versus those who receive a~          comparison program will have better outcomes during and after hospitalization as~          measured by: (1) fewer incidents of dysfunctional syndrome; (2) shorter hospital stays;~          (3) lower readmission rates; (4) less depressive symptoms; (5) higher cognitive level;~          (6) less functional decline perceived by family CG; and (7) a closer relationship with~          their family CGs.~        2. Family CGs of hospitalized elders who receive the CARE program will report: (1) More~          positive beliefs about their loved one's responses to hospitalization and their role in~          the hospital setting; (2) more positive emotional outcomes (less worry, anxiety, and~          depressive symptoms) during and after hospitalization; (3) More participation in their~          loved one's care during hospitalization; and (4) More positive role outcomes (more role~          reward, less role strain, more prepared for their loved one's care, and a closer~          relationship with their elderly relatives, both during and after hospitalization).~        3. The proposed model to explain the effects of the CARE program on the process and~          outcomes of family CG coping and elderly patient outcomes will be supported for CGs and~          elderly patients.~   "
257597|NCT00178399|"~     The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or~     hormonal therapy alone or in combination. The main purpose of this study is to evaluate~     whether radiosurgery alone affects your quality and length of life. A second purpose of this~     study is to determine if the levels of special types of protein (called cytokines) found in~     the blood are related to your quality of life during your course of treatment and follow-up.~   "
257598|NCT00178386|"~     The purpose of the study is to evaluate some educational outcomes of children treated for~     childhood cancer.~   "
257599|NCT00178373|"~     The purpose of this study is to determine the efficacy of modafinil with regard to reducing~     cancer-related fatigue in cancer patients following chemotherapy or radiation therapy.~     Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be~     assessed.~      The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing~     fatigue following completion of cancer treatment will lead to reduction in patient fatigue~     and prevention of or improvement in patient cognitive dysfunction.~   "
257600|NCT00178360|"~     The purpose of this study is primarily to assess the ability of a music therapy program to~     improve holistically the psychological, somatic, and social symptoms of patients with~     Huntington 's disease (HD). We hope to demonstrate the benefits of applying music therapy~     interventions to the management methods of HD, thus paving the way for the development of an~     effective music therapy program for individuals with HD.~   "
257601|NCT00178347|"~     Irradiation of any tissue creates changes in that tissue. Ionizing radiation imparts charges~     to the tissue as it interacts with tissue components, changing the tissue structure. The~     specific type of modification also depends to some extent upon the type of tissue irradiated.~     It has been shown that it is possible to read the tooth enamel irradiation record using~     techniques such as electron paramagnetic resonance (EPR), or electron spin resonance (ESR).~      It is proposed to examine radiation responses in approximately one hundred (100) human teeth.~     This would include teeth free of, as well as those containing, amalgam (silver) restorations.~     For the first group, teeth that have already been collected (pre-existing pathological~     specimens) would be used. These teeth were surgical/pathological discards collected without~     identifiers by the dental providers.~   "
257602|NCT00178334|"~     The purpose of this study is to:~        -  Assess the rate of screening for urinary incontinence (UI) in women by their primary~          care providers~        -  Identify the type of screening used by primary care providers~        -  Identify barriers to screening for UI~        -  Identify differences in screening rates between specialties~        -  Assess whether primary care providers view UI as a serious medical problem~        -  Assess the comfort level of primary care providers in the diagnosis and treatment of UI~        -  Identify primary care providers' preferred mode of learning more about UI~   "
257603|NCT00178321|"~     Sleep is disrupted in the PICU. This disruption has been reported in studies that have used:~     (a) observation of sleep-wake cycles (b) self-reports by children themselves , and (c)~     objective measures (e.g., electroencephalograph( EEG). Noise and light levels have been~     correlated with profound sleep disruption in the PICU . Sleep disruption is known to have a~     profound impact on the overall health of a child, both from a physiological and a~     psychological standpoint . In addition, sleep disruption has been shown to change cortisol~     levels, cause impaired immune responses and impair cognitive function in both children and~     adults . Disruption in sleep also is known to impair healing through these many complex~     connections with other homeostatic processes in the human body. What is the effect of wearing~     earplugs in critically ill children admitted to the PICU on:~        1. Sleep states~        2. Physiological stability (e.g. melatonin, cortisol and immune status)~        3. Sleep habits after discharge from the PICU (on the general pediatric unit, 2 weeks and 2~          months after discharge), and~        4. Child behavior at 2 weeks and 2 months after discharge from the PICU by parent report on~          the Child Behavior Checklist (CBCL).~   "
257604|NCT00178308|"~     The purpose of this research is to evaluate an automated, laser-based technique for measuring~     DNA damge resulting from radiation. We want to use controlled exposure on cancer patients to~     help develop a measurement to test people who may have been accidentally exposed to~     radiation.~   "
257605|NCT00178295|"~     Treatment for brain cancer may include radiation therapy. Radiation therapy is the treatment~     of tumors with X-rays. This study is related to understanding the side effects of radiation~     treatment for brain tumors.~      This study is being conducted by the University of Rochester Cancer Center to compare the~     extent of side effects of brain cancer treatment with changes in levels of blood proteins~     called cytokines.~   "
257606|NCT00178282|"~     The purpose of this study is to determine if pelvic exercises can reduce the occurrence of~     urinary incontinence (involuntary loss of urine) before and after delivery. We would also~     like to see if performing pelvic exercises before birth has an effect on labor and/or~     delivery, and if there are any specific characteristics for developing urinary incontinence~     during pregnancy and after delivery.~   "
257609|NCT00178243|"~     A study is being conducted by the University of Rochester Cancer Center (URCC) in which~     patients with liver cancer will be treated with high dose conformal radiation therapy. This~     type of radiation uses new techniques which aim the radiation to the sites of disease~     allowing the tumor to receive a high dose and the surrounding normal liver tissue to receive~     a low enough dose that the normal tissue should remain free from injury.~      The purpose of the study is to determine if the conformal radiation therapy is safe,~     tolerable and effective in treating liver cancer and to determine the side effects caused by~     this treatment. A second objective is to determine if the levels of a special type of protein~     (called cytokines) found in the blood are related to this treatment.~   "
257610|NCT00178230|"~     This study is being conducted by the University of Rochester Cancer Center to determine the~     levels of cytokines in the blood, and to determine if blood levels of these cytokines are~     related to the side effects of radiation therapy combined with other treatments.~   "
257611|NCT00178217|"~     The primary objectives for this study are:~        1. To demonstrate that music therapy can be an effective means of procedural support for~          children undergoing botox injections.~        2. To explore patient, parent and healthcare personnel satisfaction with music therapy as~          procedural support.~        3. To assess the influence of music therapy on physiologic (blood pressure, oxygen~          saturation, heart rate) and emotional (crying time) responses of patients.~   "
257612|NCT00178204|"~     The purpose of this study is to identify specific chemotherapy-related changes in sleep~     stages/architecture that may relate to an increase in fatigue in individuals with cancer.~      The researchers hypothesize that the fatigue experienced by cancer patients receiving~     chemotherapy is in part due to changes in restorative sleeping during the non-rapid eye~     movement cycles of sleep (i.e., delta activity).~   "
257613|NCT00178191|"~     The purpose of this study is to determine how effective Botox is in reducing the amount of~     urine leaked and which dose of Botox is more effective and safe in those who have urinary~     urge incontinence.~   "
257614|NCT00178178|"~     This investigation will evaluate the subjective effect on postoperative pain of three~     catheter placements in the knee:~        1. intraarticular infusion only,~        2. patellar tendon harvest site only,~        3. both intraarticular and patellar tendon harvest site.~   "
257615|NCT00178165|"~     Established in 1995, Resources for Enhancing Alzheimer's Caregiver Health (REACH) is a~     unique, multi-site research program sponsored by the National Institute on Aging (NIA) and~     the National Institute on Nursing Research (NINR). The primary purpose of REACH is to carry~     out social and behavioral research on interventions designed to enhance family caregiving for~     Alzheimer's disease and related disorders. Specifically, REACH has two goals: to test the~     effectiveness of multiple different interventions and to evaluate the pooled effect of REACH~     interventions overall. REACH grew out of a National Institute of Health (NIH) initiative that~     acknowledged the well-documented burdens associated with family caregiving as well as the~     existence of promising family caregiver interventions reported in the literature.~   "
257616|NCT00178152|"~     Erythema Toxicum Neonatorum (ETN) is a common skin finding that affects healthy full-term~     babies. Several authors have commented on the possible relationship between ETN and the~     development of atopic conditions, such as atopic dermatitis or respiratory disease later in~     life. There is a paucity of research addressing this issue.~   "
257617|NCT00178139|"~     The purpose of the study is to determine whether Music Therapy interventions can be used as~     supportive therapy for patients undergoing weaning from mechanical ventilation. The music~     will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety~     management.Music used is varied according to subject's preferences.~   "
257618|NCT00178126|"~     The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial~     (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing~     sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of~     the proposed trial will provide the level of evidence needed to change the standard of care~     to include the routine evaluation of at-risk residents for seating and positioning needs and~     the provision of pressure-reducing cushions as a preventive measure against sitting-acquired~     pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in~     the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs,~     and improved quality of life.~   "
257619|NCT00178113|"~     The purpose of this study is to determine whether dietary lycopene supplementation lowers~     serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia~     (HGPIN).~   "
257620|NCT00178100|"~     This study will evaluate the effectiveness of paroxetine versus interpersonal psychotherapy~     and a combination of the two in helping elderly patients with depression remain well and~     improve quality of their lives.~   "
257621|NCT00178087|"~     This study will determine the changes in brain structure and function that are responsible~     for mood and cognition changes that are sometimes associated with late-life depression.~   "
257622|NCT00178074|"~     This study will use positron emission tomography (PET) to examine the effect of sleep~     deprivation on brain function.~   "
257623|NCT00178061|"~     This study will examine the impact of comorbid personality disorder on the outcome of~     treatment among patients with bipolar I disorder.~   "
257624|NCT00178048|"~     The goal of the study is to examine the role of paroxetine, an antidepressant medication, in~     the acute and continuation treatment of insomnia. Primary insomnia is a type of insomnia not~     directly resulting from general medical, chemical, or psychiatric conditions.~   "
257625|NCT00178035|"~     This study will determine the effectiveness of total sleep deprivation (TSD) for one night~     plus paroxetine versus either TSD plus placebo or paroxetine alone in inducing rapid symptom~     resolution of major depression in the elderly.~   "
257626|NCT00178022|"~     The primary aims of this project are to examine the feasibility and relative efficacy of two~     models of on-line intervention for families of children with traumatic brain injury: one, a~     model emphasizing cognitive appraisals and problem solving skills; the other, emphasizing~     linking families to resources and providing professionally-moderated peer support.~   "
257685|NCT00177229|"~     The purpose of this study is to determine if a family based diet and exercise program is~     helpful for extremely overweight children aged 8-12, and to compare this approach to standard~     medical management of severe pediatric obesity.~   "
257627|NCT00178009|"~     Discharge to the community is increasingly becoming a priority for patients implanted with a~     Ventricular Assist Device (VAD). Because VADs are complex, patients and caregivers often fear~     leaving the hospital, although their status does not require hospitalization. This project~     includes development of CD/video and web-based instructional programs on management of the~     VAD controller for patients and their caregivers (formal and informal). A clinical trial will~     be used to examine discharge rates and placements following patients educated under usual~     care vs. self-pace CD/video conditions.~   "
257628|NCT00177996|"~     This research study is being conducted to find out if certain individuals benefit from taking~     medication for their depression with a low dose of the antidepressant medication Zoloft.~   "
257629|NCT00177983|"~     This study will assess the feasibility of using the internet and in-home computers to provide~     advice from health care professionals, social support, and health information to people with~     schizophrenia and their families.~   "
257630|NCT00177970|"~     In this trial, eligible patients will be randomly assigned to receive a single dose of 400~     mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their~     usual medications for CDAD. We expect to enroll approximately 40 patients over a period of~     two years from UPMC Shadyside Hospital, McKeesport Hospital, and St. Margaret's Hospital who~     are unresponsive to standard antimicrobial therapy for CDAD.~      During the course of this study we expect that IVIG group compared with placebo group will~     have fewer number of stools per day (< 3 per day). Secondary endpoints will include normal~     WBC count, normal body temperature, 75% reduction in abdominal pain / tenderness, and~     decrease in length of hospital stay.~      Subjects will sign a written informed consent prior to any study procedures. Patients will be~     monitored closely during the infusion of the study medication and will continue to be~     monitored on a daily basis up to the time of discharge. Data collection will include vital~     signs, CBC, stool C. difficile cytotoxin assay, and stool counts before and after therapy.~   "
257631|NCT00177957|"~     The aims of this study are to:~        -  Determine the risk factors for multidrug resistance in bloodstream isolates of Gram~          negative bacilli~        -  Determine the mechanisms of multidrug resistance in bloodstream isolates of Gram~          negative bacilli~        -  Determine the risk factors for failure of prompt clearance of the blood of Gram negative~          bacteria~        -  Determine the survival of patients with Gram negative bacteremia~        -  Determine if failure of prompt clearance of the blood of Gram negative bacteria is a~          predictor of mortality following this infection~   "
257632|NCT00177944|"~     The purpose of this study is to optimize the management of patients treated for invasive~     fungal infections by establishing a real-time, continuous clinical data base that will~     capture and monitor trends in the epidemiology, diagnosis, treatment and outcomes of invasive~     fungal infections; reflect routine clinical management of patients with invasive fungal~     infections in order to evaluate treatment and provide a rationale for future treatment~     paradigms; and allow physicians to assess adherence to institutional clinical practice~     guidelines, validate current standardized definitions for patients with invasive fungal~     infections and promote change where appropriate.~   "
257633|NCT00177931|"~     The purposes of this study are to:~      I. Characterize the plasma concentration-time profile of cefepime in liver transplant~     patients to determine the pharmacokinetic parameters in this patient population.~      II. Perform stochastic modeling using the population pharmacokinetic parameters obtained in~     Specific Aim I to determine the ideal dose and dosing regimen of cefepime required to attain~     predetermined therapeutic targets in liver transplant patients.~   "
257634|NCT00177918|"~     The primary aim of this study is to determine prospectively the viral and C. pneumoniae~     infection prevalence and outcomes of infections in lung transplant recipients. The study will~     also determine the correlation of C. pneumoniae infection with the development of obliterans~     in lung transplant recipients.~   "
257635|NCT00177892|"~     The purpose of this study is to define the mechanism(s) through which Obstructive Sleep~     Apnea/Hypopnea (OSAH) promotes abnormal metabolic processes which characterize the metabolic~     syndrome. The investigators hypothesize that the sleep fragmentation and intermittent sleep~     hypoxia which occur in OSAH patients promote oxidative stress and inflammation which in turn~     lead to insulin resistance, dyslipidemia, abnormal vascular reactivity and other processes~     which are consistent with the metabolic syndrome.~   "
257636|NCT00177879|"~     This study will determine the usability of a website for people with schizophrenia versus~     other websites designed for the same purpose.~   "
257637|NCT00177866|"~     The investigators will select 60 people who are 18-70 years of age with Crohn's disease and~     randomly assign them to receive an 8-week trial of celecoxib and an 8-week trial of a~     placebo. There will be a 1-week interval or wash-out between trials when the participant~     does not take any study medication. The investigators will monitor the participants for 18~     weeks after they start the medication and observe their Crohn's disease activity, assessing~     for flare-ups or exacerbations in the disease and other possible side effects of celecoxib.~     Based on these observations, a determination will be made by the investigators as to the~     safety of celecoxib. If celecoxib is found to be safe, then it may provide physicians with a~     medication that they can prescribe for people who have Crohn's disease and experience chronic~     pain from arthritis and arthralgia.~   "
257638|NCT00177853|"~     The purposes of this study are to examine the effects of a new combination of drugs,~     celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people~     before they undergo surgery; to determine what effects this combination has on pancreatic~     cancer; and to determine the highest dose of celecoxib and irinotecan that can be given~     safely without causing severe side effects. While not an endpoint, it is hoped that this~     combination will also shrink tumors enough for excision.~   "
257639|NCT00177840|"~     This study will evaluate if acupuncture is helpful in treating cancer-related fatigue in~     breast cancer patients undergoing radiation therapy.~   "
257648|NCT00177723|"~     The study will evaluate and improve the performance of pharmaco-statistical models previously~     developed in the compassionate use program in patients being treated with linezolid under~     clinical usage conditions. This study will also develop a sensitive and specific tool that~     may be used to predict patients at risk of hematological toxicity, based on factors including~     linezolid concentration and duration of therapy and use these models to better understand the~     determinants of toxicity with linezolid and define better strategies to manage toxicity or~     reduce its occurrence.~   "
257640|NCT00177827|"~     A fixed dosage regimen of voriconazole is routinely used for prophylaxis of aspergillosis in~     lung transplant patients at our institution. We hypothesize that use of a fixed dosage~     voriconazole regimen leads to large degree of variability in drug exposure among lung~     transplant patients and consequently, therapeutic failures or toxicity. This is a three part~     study which will examine plasma and lung voriconazole concentrations achieved with the~     prophylactic regimen and assess for a correlation between these concentrations with efficacy~     and toxicity. We aim to conduct an initial pilot study in 12 lung transplant patients to~     characterize the pharmacokinetic profile of voriconazole with both intravenous and oral~     doses. The data gathered from the pilot pharmacokinetic study will then be utilized to~     correlate trough concentrations with total voriconazole drug exposure as measured by area~     under the plasma concentration versus time curve (AUC). Additionally, trough concentrations~     will be followed over nine weeks of the prophylactic treatment period in a larger cohort of~     patients to determine maintenance of consistency in trough concentrations and whether the~     plasma concentrations are predictive of efficacy and toxicity. Voriconazole lung~     concentrations will be measured in a pilot study of 12 patients who undergo a bronchoscopy~     procedure as part of their standard medical care in order to determine the relationship~     between plasma and lung concentrations. The information obtained from this three phase study~     will be utilized to characterize the pharmacokinetics of voriconazole in lung transplant~     patients. Further, it will be used to define an optimal therapeutic voriconazole regimen that~     will be individualized to target specific concentrations in the lung and plasma to maximize~     efficacy and minimize toxicity~   "
257641|NCT00177814|"~     The proposed endpoints of the study would be: comparative use of piperacillin versus broader~     spectrum agents (e.g., piperacillin/tazobactam, etc.) [measured as defined daily doses per~     1000 patient days]; physician acceptance of piperacillin as part of a streamlining program~     [measured as successful occurrences of the use of piperacillin as streamlining therapy];~     changes in susceptibility patterns of broad spectrum antibiotics [measured as % Gram negative~     bacilli susceptible to each of the commonly used broad spectrum antibiotics]; and outcome of~     patients treated with streamlined therapy.~   "
257642|NCT00177801|"~     Fungal infections are leading causes of morbidity and mortality in transplant recipients, yet~     comprehensive epidemiologic studies in this area are lacking. For this reason, the Centers~     for Disease Control and Prevention have provided a grant to the University of Pittsburgh to~     study this subject.~      The study has four specific aims:~      1. To determine the risk of fungal infections in a center where tolerogenic~     immunosuppressive protocols are currently in place, and to determine whether there are any~     measures of immune system function which correlate with risk of fungal infection.~      2: To create a repository of serum, urine and bronchoalveolar lavage specimens for the~     purpose of determining the effectiveness of novel diagnostic tests for invasive fungal~     infections. Such a repository could also be utilized for the purpose of determining the~     effectiveness of novel diagnostic tests for viral infections such as West Nile Virus,~     cytomegalovirus, HHV-6 and HHV-8.~      Specific aim 1 will be investigated by creating a prospective database of solid organ~     transplant recipients at the University of Pittsburgh Medical Center, including demographic~     factors as well as subsequent development of infection. The immune function of patients will~     be assessed by measuring T cell subsets and assessing T cell function using the Cylex assay.~     Specific aim 2 involves collection of serum, urine and bronchoalveolar lavage fluid. These~     specimens will be stored and later tested at the Centers for Disease Control and Prevention~     in the assessment of novel tests developed for the diagnosis of invasive fungal infections.~   "
257643|NCT00177788|"~     The study aims to determine if voriconazole prevents invasive fungal infections in liver~     transplant recipients. Endpoints would be: occurrence of invasive fungal infection and fungal~     colonization. Two groups will be compared: patients who received voriconazole as prophylaxis~     and historical controls who did not receive this prophylaxis.~   "
257644|NCT00177775|"~     The primary objective of this study is to assess the safety of the investigational agent,~     MucoMilk®, a polyclonal-antibody enriched Whey Protein Concentrate 40% (WPC-40) made of milk~     of immunized cows. Secondary objectives will investigate the effectiveness of MucoMilk® as an~     aid in the prevention of relapse of C. difficile-associated diarrhea (CDAD).~   "
257645|NCT00177762|"~     The purpose is to examine varying durations and intensities of exercise on long-term weight~     loss.~   "
257646|NCT00177749|"~     Therapeutic options for serious fungal infections are limited by intrinsic and acquired~     resistance to existing antifungal agents. For example, zygomycetes (such as Mucor spp.) are~     intrinsically resistant to voriconazole and caspofungin. Yet, the only available therapeutic~     option, amphotericin, is associated with significant renal toxicity, even in lipid~     formulations. Posaconazole is a new antifungal drug, not yet Food and Drug Administration~     (FDA) approved, but which has excellent in vitro activity against some intrinsically~     resistant fungi such as the zygomycetes.~      The intent of this trial is to provide access to posaconazole to patients with serious fungal~     infections which are refractory to standard antifungal therapies or invasive fungal~     infections for which there are currently no effective therapies. Secondly, the drug will also~     be made available to patients with invasive fungal infections who:~        -  have experienced serious or severe toxicities while receiving standard antifungal~          therapies;~        -  have pre-existing renal dysfunction which precludes use of standard antifungal~          therapies; or~        -  are chronically immunosuppressed with a history of invasive fungal infections previously~          treated with posaconazole in other clinical trials, and who require oral antifungal~          suppressive therapy as maintenance treatment to prevent recurrence.~      This is a multicenter, open-label, non-comparative experimental treatment use protocol. The~     experimental treatment use protocol will provide the investigational medication posaconazole~     where no other drug is commercially available. Posaconazole is given as an orally or~     enterally administered suspension. The duration of therapy is at the discretion of the~     investigator. Safety assessments will include an electrocardiogram [ECG] (to ensure no QTc~     interval prolongation) performed at baseline and serum/urine pregnancy testing performed at~     baseline and every three months after initiation of therapy. Plasma concentrations will be~     obtained if there is evidence of clinical failure. No other tests will be performed~     specifically for the experimental treatment use protocol.~   "
257647|NCT00177736|"~     Pharmacokinetics is the study of the disposition of drugs in the body, while pharmacodynamics~     considers the interaction of the drug at the site of infection over time. Mathematical models~     of antibiotic pharmacodynamics are sometimes used to predict if antibiotic doses are~     sufficient to treat infection with organisms of different minimal inhibitory concentrations~     of the antibiotic. Based on these models, there has been speculation that the antibiotic~     cefepime dosed at one gram every 12 hours, is insufficient to kill all organisms within the~     susceptible range. This study of patients treated with cefepime will involve the collection~     of blood to determine cefepime concentrations, and determine if those concentrations are~     effective in killing the bacteria at the site of infection.~   "
257649|NCT00177710|"~     The purpose of this study is to determine the steady state concentrations of inhaled~     liposomal amphotericin B (Ambisome®) in lung transplant recipients via aerosolized~     nebulization.~   "
257651|NCT00177684|"~     The purpose of this study is to determine the optimal delivery system for the nebulization of~     the lipid complex amphotericin B (Abelcet ®) in lung transplant recipients who are positive~     for invasive aspergillosis (IA) in their lungs. Additionally, the investigators hope to~     determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and~     serum with the administration of four days of lipid complex of amphotericin B (Abelcet ®)~     (QD) via aerosolized nebulization~   "
257652|NCT00177671|"~     This study will determine the effectiveness of combining escitalopram, venlafaxine, or~     duloxetine with donepezil, a medication used in Alzheimer's disease, in improving memory,~     concentration, attention, and problem solving abilities, and reducing the risk of depressive~     relapse in older individuals with depression.~   "
257653|NCT00177658|"~     To determine the clinical significance of gene mutations encoding antibiotic resistance, but~     not expressed as clinical resistance, in Salmonella bacteria~   "
257654|NCT00177645|"~     The purpose of this study is to see if inhaled bicarbonate will increase the ability to cough~     up mucus in a person with cystic fibrosis.~   "
257655|NCT00177632|"~     The purpose is to examine the additional effect of either yoga or resistance exercise on~     weight loss weight combined with a standard behavioral weight loss intervention.~   "
257656|NCT00177619|"~     The overall goal of this proposal is to determine the effectiveness and safety of once weekly~     alendronate (Fosamax) in the prevention and treatment of osteoporosis in men with prostate~     cancer on androgen deprivation therapy and to evaluate maintenance of bone mass following~     termination of therapy after one year.~   "
257657|NCT00177606|"~     The purpose of this study is to validate a set of proposed clinical criteria that have been~     designed to identify patients who will die rapidly following the elective removal of life~     sustaining treatments.~   "
257658|NCT00177593|"~     The purpose of this study is to examine the effect of a computer tracking system and energy~     expenditure device on weight loss in adults.~   "
257659|NCT00177580|"~     This study supplements patients' current medications with Pravastatin, a cholesterol-lowering~     medication, to try to improve residual symptoms of schizophrenia, and also to improve~     cognitive functioning.~   "
257660|NCT00177567|"~     The purpose of this study is to collect pilot data on the feasibility of recruiting,~     eliciting informed consent, assessing, treating, and following patients aged 60 and older~     with bipolar mood disorders.~   "
257661|NCT00177554|"~     The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy~     in followed by Zevalin in previous untreated patients with follicular lymphoma~   "
257662|NCT00177541|"~     To determine the mechanisms mediating the therapeutic efficacy of pelvic floor muscle~     exercises and biofeedback for urge urinary incontinence, as well as the characteristics of~     patients most likely to respond. By identifying the key components of this treatment, we hope~     to simplify it and make it more easily applicable, more effective, less expensive, and thus~     more useful for people with urge incontinence in the future.~   "
257663|NCT00177528|"~     This research study is to evaluate the safety and usefulness of venlafaxine-XR in the~     treatment of major depression in the elderly.~   "
257664|NCT00177515|"~     The purpose of this study is to determine whether video doctor programs can effectively~     deliver preventive health messages to women of reproductive age while they wait to be seen in~     urgent care settings. In this study, the specific hypotheses being tested are: 1) is the~     video doctor program effective in improving women's knowledge about emergency contraception,~     and 2) is the video doctor program effective in improving women's knowledge about the~     importance of folate.~   "
257665|NCT00177502|"~     The purpose of this study is to examine the dose-response of exercise on prevention of weight~     gain in overweight adults.~   "
257666|NCT00177489|"~     The primary goal of this study is to test a single multi-component intervention among family~     caregivers of persons with Alzheimer's disease or related disorders. The overall objectives~     of study are to 1) identify and reduce modifiable risk factors among diverse family~     caregivers of patients with Alzheimer's Disease or a related disorder, 2) enhance the quality~     of care of the care recipients, and 3) enhance the well-being of the caregivers.~   "
257667|NCT00177476|"~     The purpose of this study is to examine whether behavioral strategies implemented during the~     adoption versus the maintenance periods of weight loss to enhance exercise participation in~     overweight adults are more effective than a standard behavioral intervention.~   "
257668|NCT00177463|"~     Our hypothesis is that oral L-carnosine treatment (as compared with placebo) will enhance~     cognitive abilities (specifically: measures of attention, executive function, working memory,~     visuospatial ability and language) in persons with bipolar disorder. Secondarily, we~     hypothesize there will be secondary improvements in positive, negative and mood symptoms with~     L-carnosine treatment.~      We aim to test these hypotheses by conducting a randomized, placebo controlled, add on~     treatment trial of L-carnosine (added to existing antipsychotic treatment) on 48 recruited~     subjects with DSM IV TR bipolar disorder for a period of 12 weeks. Measures of cognition, and~     psychopathology will be utilized for evaluating primary and secondary outcomes, along with~     safety assessments.~   "
257669|NCT00177437|"~     This is a randomized controlled trial to determine whether a home screening test for~     chlamydia and gonorrhea will lead to increased use of screening tests and increased detection~     of sexually transmitted diseases.~   "
257670|NCT00177424|"~     This study will determine the effectiveness of sertraline administration after a stroke in~     preventing the onset of post-stroke depression.~   "
257686|NCT00177216|"~     This study will compare the symptoms, experiences, and laboratory sleep characteristics of~     young adults with and without insomnia.~   "
257687|NCT00177203|"~     This project will test the efficacy of a brief, 2 session behavioral intervention for~     insomnia, as compared to an information-only condition. We hypothesize that compared to those~     receiving the information-only intervention, those assigned to BBTI will have superior~     short-term outcomes and retain the gains made, at 12 months.~      We will also compare older insomniacs to age matched good sleepers through measurers of~     mental and physical health, sleep, and general functioning. We hypothesize that the insomnia~     cohort will have more physical and mental health disorders of a greater severity than the~     age-matched controls.~   "
260390|NCT00141362|"~     Evaluate long-term safety and efficacy of pregabalin in patients with chronic neuropathic~     pain.~   "
257671|NCT00177411|"~     This is a single-blinded, one-treatment, combination dose escalation and pharmacokinetic~     study done in healthy volunteers. The investigators want to determine whether Parathyroid~     Hormone related Protein (1-36) [PTHrP(1-36)] shares anabolic properties with the only~     currently approved anabolic agent, parathyroid hormone(1-34) [PTH(1-34)], which stimulates~     both osteoblastic bone resorption and formation. In a previous study done by the~     investigators, postmenopausal osteoporotic women on estrogen received 6.56 mcg/kg PTHrP(1-36)~     subcutaneously for three months daily. They experiences a 4.7% increase in bone mineral~     density (BMD) of the lumbar spine when compared with those taking placebo. They also~     displayed an increase in serum osteocalcin, a marker of bone formation, with no change in~     several markers of bone resorption. It is believed that the rapid absorption and clearance of~     PTHrP(1-36) likely plays a central role in its anabolic effect In order to further assess~     absorption, we are combining both pharmacokinetic and dose escalation methods for studying~     intravenous PTHrP given via a one-time bolus injection. The purpose is to define the maximum~     safe dose and measure the pharmacokinetic parameters of a single intravenous dose of~     Parathyroid Hormone-related Protein (1-36)[PTHrP(1-36)]. The results will be useful in~     determining future treatment options for osteoporosis.~   "
257672|NCT00177398|"~     The purpose of this study is to determine if the early initiation of a long acting insulin~     (i.e. glargine) with supplemental doses of short acting regular (SSR) insulin in hospitalized~     patients with diabetes who are fed using tube feedings reduces the frequency of high and low~     blood sugar levels when compared to use of SSR insulin alone.~   "
257673|NCT00177385|"~     The purpose of this study is to see whether protecting sleep quality in later life is~     important in continued healthy aging. The value of education in healthy sleep practices along~     with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary~     practices will be tested for their effects on sleep quality, health, and well being.~   "
257674|NCT00177372|"~     This is a pilot clinical trial to evaluate whether the medical management of early pregnancy~     failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects~     with early pregnancy failure receive mifepristone followed 24 hours later by vaginal~     misoprostol for medical management. Subjects then return on study day 3 for a repeat~     ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac~     present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up~     at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol,~     and in person for those who received a second dose. Questionnaires are administered at the~     beginning and end of the study to determine acceptability.~   "
257675|NCT00177359|"~     The purpose of the study is to examine the effect of an intervention to improve walking based~     on motor learning (skill-based) compared to the usual intervention (strength, flexibility and~     balance-based) on clinical, psychological and laboratory measures of walking and balance of~     older adults with mobility disability (walking problems).~   "
257676|NCT00177346|"~     The primary objective of this study is to evaluate carotid artery stenting (CAS) with and~     without cerebral protection (CP) to determine if CP improves safety and effectiveness of CAS.~   "
257677|NCT00177333|"~     This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion~     doxycycline. The aims of the study are to determine the serum levels of doxycycline when~     administered pre-operatively 4 hours or approximately 18 hours before a dilation and~     evacuation (D & E) abortion. The hypotheses being tested are that subjects who receive~     doxycycline with food the night before an abortion will have adequate serum levels, but less~     nausea and vomiting compared to women who take the doxycycline on an empty stomach on the~     morning of the abortion. Subjects will either take 200mg doxycycline on the night before and~     2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night~     before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will~     look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels~     will be collected from the subjects at the time of surgery.~   "
257678|NCT00177320|"~     Computers allow individuals to engage in economic, social, and entertainment activities.~     Despite the many benefits of computer use, many individuals with rheumatic diseases may have~     difficulty using a computer. However, currently there is almost no information on the~     problems individuals with rheumatic diseases experience using a computer. Baseline~     information on the types of problems experienced by individuals with rheumatic diseases as~     well as the magnitude of those problems is needed before methods can be developed to~     intervene and remediate them. In this study we will develop and administer to a~     representative sample of patients with rheumatic diseases a survey which will examine the~     type and magnitude of computer problems experienced by those with rheumatic diseases. The~     goal of this study is to complete a needs assessment on the problems experienced by those~     with rheumatic diseases during computer use. This assessment will lay the groundwork for the~     development of outcome measures and interventions to improve computer use for individuals~     with rheumatic diseases. In the future it will assist individuals with rheumatic diseases to~     be able to use computers more comfortably and efficiently.~   "
257679|NCT00177307|"~     This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine.~     This is an open-label study.~   "
257680|NCT00177294|"~     This study will determine whether adding interpersonal psychotherapy to treatment with the~     antidepressant escitalopram will be more effective in reducing symptoms of depression than~     antidepressant medication alone.~   "
257681|NCT00177281|"~     The purpose of this research study is to evaluate a new anti-cancer drug called S CKD602,~     developed by ALZA Corporation. The drug is investigational and not approved by the Food and~     Drug administration (FDA). The side effects (the way the drug acts in your body) and the~     effect it has on your disease will be studied.~   "
257682|NCT00177268|"~     This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL),~     eczema, and atopic dermatitis patients for current and future research.~   "
257683|NCT00177255|"~     This is a phase II study that will investigate weekly dosing of docetaxel in combination with~     capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.~   "
257684|NCT00177242|"~     This is a phase II, open-label trial of Gefitinib and docetaxel in patients having one prior~     regimen of chemotherapy for with metastatic pancreatic carcinoma.~   "
261143|NCT00131430|"~     A study to determine the safety and efficacy of an investigational drug in patients with~     obesity.~   "
257688|NCT00177190|"~     This is an in vitro evaluation of cutaneous T-cell lymphoma using patients' blood and tissue~     to evaluate immune responses related to identified tumor populations and dendritic/CD 8~     cells.~   "
257689|NCT00177177|"~     The investigators' hypothesis is that oral L-carnosine treatment (as compared with placebo)~     will enhance cognitive abilities (specifically: measures of attention, executive function,~     working memory, visuospatial ability and language) in persons with schizophrenia or~     schizoaffective disorder. Secondarily, they hypothesize that there will be secondary~     improvements in positive, negative and mood symptoms with L-carnosine treatment.~      The investigators aim to test these hypotheses by conducting a randomized, placebo~     controlled, add-on treatment trial of L-carnosine (added to existing antipsychotic treatment)~     up to 84 recruited subjects with Diagnostic and Statistical Manual of Mental Disorders, 4th~     Edition, Text Revision (DSM-IV-TR) schizophrenia/schizoaffective disorder for a period of 16~     weeks. Measures of cognition and psychopathology will be utilized for evaluating primary and~     secondary outcomes, along with safety assessments.~   "
257690|NCT00177164|"~     We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who~     were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in~     the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments.~     Patients were titrated and cross-tapered during a 3 month titration and stabilization phase.~     They were followed for an additional 12 months. Clinical outcomes such as study drop out,~     adverse events, worsening of symptoms, crisis interventions, need for additional medication,~     hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events~     (pooled) will be used to evaluate if the long acting injectable form of risperidone has an~     advantage over the oral second generation antipsychotic agents in terms of treatment~     continuity and clinical stability.~   "
257691|NCT00177138|"~     This is a single center, prospective, open-label, randomized trial at the University of~     Minnesota Medical Center,Fairview.~      Primary objectives are to determine if rejection episodes and loss rates, graft survival,~     level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1)~     immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin,~     tacrolimus, and MMF (Group 2).~      This study will investigate the first protocol that is both steroid-free and calcineurin~     inhibitor-free in pancreas after kidney transplant recipients.~   "
257692|NCT00177125|"~     The purpose of this study is to perform a randomized prospective study to evaluate whether~     the vacuum erection device facilitates an earlier return of erectile function post radical~     prostatectomy. A secondary measure will be to evaluate if the vacuum erection device can help~     prevent penile shortening.~   "
257693|NCT00177112|"~     The purpose of this study is to verify that the incidence rate of urinary tract infections~     after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile~     procedural techniques.~   "
257694|NCT00177099|"~     The purpose of this study is to determine if immunophilin ligands may have the potential to~     reverse hair loss.~   "
257695|NCT00177086|"~     This study will assess improvement in the percentage of spontaneous stone passage for distal~     ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic~     use associated with stone passage, decrease of the time to spontaneous stone passage, shift~     in the size distribution of stones passed towards larger sizes.~   "
257696|NCT00177060|"~     The hypothesis is that topical opioids will hasten wound healing in humans.~   "
257697|NCT00177047|"~     This is a study of a regimen of melphalan and autologous stem cells for patients with~     multiple myeloma. We hypothesize that this particular regimen will improve the survival of~     these patients.~   "
257698|NCT00177034|"~     The keratinocytes of lesional skin of vitiligo compared to normal and perilesional skin will~     differentially express genes correlating with melanocyte death. Narrow Band UVB should then~     hopefully reverse the pattern of gene expression back toward normal.~   "
257699|NCT00177021|"~     We propose to examine the efficacy and tolerability of Aldara Cream 5% for the treatment of~     extensive alopecia areata. Aldara is a immune-response modifier. The drug induces the~     production of cytokines which are small, hormone-like proteins involved in cellular~     communication during immune responses. We hypothesize that this drug will effect the~     inflammatory cells present around hair follicles in patients with alopecia areata.~   "
257700|NCT00177008|"~     This study will determine the efficacy of a medication switch to Aripiprazole for the~     treatment of schizophrenia or schizoaffective disorder in patients with moderate to high~     symptoms of social anxiety. Specifically the study will test the possibility that a~     medication switch to Aripiprazole reduces symptoms of social anxiety in this patient~     population.~   "
257701|NCT00176995|"~     This trial is designed to gain insight into the mechanism of action of eflornithine~     hydrochloride in men and to aid in determining if this compound is deserving of further~     development for a pseudofolliculitis barbae indication. This study will also provide~     knowledge which will be useful in designing future PFB trials in this indication is pursued.~   "
257702|NCT00176982|"~     Alopecia areata is an autoimmune condition resulting in hair loss and complete baldness~     (alopecia totalis). Published evidence says that it is mediated by T-lymphocytes. Plaquenil~     is an anti-inflammatory drug approved by the FDA for malaria, lupus erythematosus, and~     rheumatoid arthritis. It has an effect on T-lymphocyte mediated inflammation, making it a~     logical choice for a treatment trail for alopecia areata.~   "
257703|NCT00176969|"~     It has been postulated that Alopecia Areata (AA) is, at least in part, a neurologically~     mediated disease. Research supporting this theory includes the finding that nerves~     surrounding the hair follicles are collapsed. We want to take this research a step further~     and show that not only are these perifollicular nerves collapsed, but that their function is~     also impaired.~   "
257704|NCT00176956|"~     The skin disease found in pediatric heart transplant patients represents an atopic~     dermatitis-like rash that is refractory to systemic immunomodulation.~   "
257705|NCT00176943|"~     It is thought that alopecia areata occurs as the result of an inappropriate response of the~     body's own immune system to certain substances in or around the hair follicle. We will be~     examining the efficacy of Aldara Cream 5% in treating extensive alopecia areata and observe~     its affect on the hair follicle.~   "
258351|NCT00168402|"~     This is a three-year study in subjects with axillary hyperhidrosis involving injection of~     Botulinum Toxin Type A into the axilla to reduce sweating.~   "
257706|NCT00176930|"~     The purpose of this study is to develop a standard of care treatment using allogeneic stem~     cells for patients with cancers of the blood.~      The protocol was revised to reflect that this study is considered treatment guidelines,~     rather than a research study.~   "
257707|NCT00176917|"~     The purpose of this study is to determine the safety and engraftment of donor hematopoietic~     cells using this conditioning regimen in patients undergoing a hematopoietic (blood forming)~     cell transplant for Hurler syndrome, Maroteaux Lamy syndrome, Mannosidosis, or I-cell~     disease.~   "
257708|NCT00176904|"~     The purpose of this study is to determine the safety and engraftment of donor hematopoietic~     cells using this conditioning regimen in patients undergoing a hematopoietic (blood forming)~     cell transplant for an inherited metabolic storage disease.~   "
257709|NCT00176891|"~     The investigators hypothesize that weekly infusions of Laronidase ERT for 10-12 weeks prior~     to transplant and 8 weeks following transplant will result in a reduction of~     glycosaminoglycans (GAG) burden that is associated with decreased complications following~     transplant.~   "
257710|NCT00176878|"~     The researchers hypothesize that it will be possible to perform unrelated bone marrow or cord~     blood transplants in a safer manner by using less intensive therapy yet still achieve an~     acceptable level of donor cell engraftment for non-malignant congenital bone marrow failure~     disorders.~   "
257711|NCT00176865|"~     This study tests the clinical outcomes of a preparative regimen of fludarabine (FLU),~     anti-thymocyte globulin (ATG)/or Campath, and melphalan; followed by hematopoietic stem cell~     transplant, and a post transplant regimen of Cyclosporin A (CsA) in patients with immunologic~     or histiocytic disorders. The researchers hypothesize that this regimen will have a positive~     effect on post transplant engraftment and the incidence of graft-versus-host-disease (GVHD).~      Patients will be randomized biologically into one of 3 arms based upon donor availability:~     (a) human leukocyte antigen (HLA) genotypic matched sibling donor, (b) HLA phenotypic matched~     unrelated peripheral blood stem cell (PBSC) donor, (c) two HLA 0-2 antigen mismatched~     unrelated cord blood donors (double cord).~   "
257712|NCT00176852|"~     This study tests the clinical outcomes of one of two preparative regimens (determined by~     available donor source) in patients with non-malignant hemoglobinopathies. The researchers~     hypothesize that these regimens will have a positive effect on post transplant engraftment~     and the incidence of graft-versus-host-disease.~      Regimen A2 has replaced Regimen A in this study. Two patients were treated on Regimen A but~     did not have evidence of initial engraftment thus triggering the stopping rule for that arm~     of this study.~   "
257713|NCT00176839|"~     This protocol using busulfan, cyclophosphamide and melphalan has been designed as~     conditioning therapy for patients receiving stem cell transplantation for acute leukemia or~     myelodysplastic syndrome (MDS). The hypothesis is that this new regimen will be well~     tolerated and will cure the patient.~   "
257714|NCT00176826|"~     The hypothesis is to determine if a preparative regimen of busulfan, cyclophosphamide, and~     antithymocyte globulin (ATG) plus allogeneic stem cell transplantation will be effective in~     the treatment of immune deficiencies and histiocytic disorders.~   "
257715|NCT00176813|"~     This study will examine an investigational (experimental) treatment using gemcitabine,~     cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may~     be effective in reducing the size of cancerous tumors and/or preventing further tumor growth.~      This is a phase II clinical trial studying the reactions of the patient's body and their~     tumor to the combination of gemcitabine, cisplatin, and celecoxib. The purpose of this study~     is to see if the tumor responds to this treatment and to determine how long the response~     lasts. This study will also look at what kind of side effects this experimental treatment~     causes and see how often these side effects occur. Blood levels of celecoxib will be measured~     to find out how this treatment affects factors (proteins) involved in new blood vessel~     formation and tumor growth (angiogenesis).~   "
257716|NCT00176800|"~     Surgery has been the standard of care for esophageal cancer for many years, with limited~     success. At present, several studies are underway nationwide which utilize chemotherapy~     combined with radiation therapy prior to the usual surgical regimen. Although this treatment~     offers some possibility for improvement of patients with esophageal cancer, there remains a~     significant need for development of new drugs that can substantially impact survival~      Investigators at the University of Michigan have been evaluating inhibitors of tumor blood~     vessel growth (angiogenesis). Specifically, they are evaluating the role of copper in~     angiogenesis. Copper has been shown to be both a requirement and a potent stimulus for~     angiogenesis.~      Previous studies have shown Tetrathiomolybdate (TM) to rapidly lower copper levels in the~     blood. The physicians at the University of Michigan are studying whether the addition of TM~     to the chemoradiation and surgery may increase survival for patients with esophageal cancer.~   "
257717|NCT00176787|"~     This study will use an experimental combination of treatment with the drug Capecitabine and~     radiation therapy prior to an operation for removal of the patient's tumor. The drug~     Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal~     cancer.~      This is a phase II clinical trial, which means that the physician will be studying the~     reactions of the patient's body and tumor to treatment with Capecitabine and radiation~     therapy. The purpose of this study is to see if the tumor responds to this treatment and to~     determine how long the response lasts. The study also will see what kind of side effects this~     experimental treatment causes and see how often these side effects occur.~      Preliminary human studies using Capecitabine and radiation therapy have produced encouraging~     results with acceptable side effects.~   "
257718|NCT00176774|"~     This study will examine an investigational (experimental) agent Tetrathiomolybdate (TM)~     combined with the chemotherapy drugs Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (LV).~     This study will evaluate the safety and tolerability of the combination of these drugs when~     they are used in the treatment of metastatic colorectal cancer.~      This is a pilot clinical trial which will be studying the reactions of the patient's body and~     tumor to the experimental treatment described above. The purpose of this study is to find out~     what kind of side effects this experimental treatment causes and see how often these side~     effects occur.~   "
257820|NCT00175435|"~     This study will look at what happens to the level of protection against hepatitis B (HB)~     disease if a 'helper' gel is applied to the skin over the injection site of a small dose of~     hepatitis B vaccine.~   "
257719|NCT00176761|"~     This study is being conducted to determine the efficacy, side effects, and toxicity of an~     investigational vaccine that consists of tumor-pulsed dendritic cells administered with an~     immune stimulating drug called interleukin-2 (IL-2). Dendritic cells are immune cells that~     are obtained from a subject's blood and are important in the body’s immune response to~     foreign substances. This study will examine the response of a subject's immune system after~     receiving several vaccinations containing their own dendritic cells which have been exposed~     to dead fragments of their cancer cells in the laboratory. This may result in sensitizing a~     subject's dendritic cells to their cancer cells so that their dendritic cells will react with~     other cells of the immune system and attack the cancer. It has been shown in the laboratory~     that dendritic cells exposed to cancer cell fragments can provide lymphocytes (a type of~     white blood cell) with signals they require in order to become fully activated and acquire~     the ability to kill cancer cells.~   "
257720|NCT00176748|"~     This study is being done to find out the good and bad effects of an investigational drug that~     is not approved for sale, called AG-013736. Tumors need blood vessels in order to continue to~     grow, and AG-013736 is thought to work by playing a role in preventing new blood vessels from~     growing. We want to see if AG-013736 has any effect on your disease by making your tumor~     smaller and if so, for how long. We also want to test the safety [the effect on your body] of~     AG-013736 and to measure the amount of AG-013736 that gets into your blood. AG-013736 has~     been given to over 140 patients with cancer on other studies.~   "
257721|NCT00176735|"~     Pancreatic cancer has traditionally been treated with chemotherapy and radiation therapy with~     limited results. Preliminary studies of parts of this program in patients with advanced~     pancreatic cancer have produced favorable results with acceptable side effects. We feel that~     this treatment sequence may help to slow and/or control the growth of pancreatic cancer.~      This study will help doctors learn whether pancreatic cancer will respond to this treatment.~     This study will use the combination of two chemotherapy drugs, gemcitabine and cisplatin,~     before and after treatment with radiation therapy and an oral chemotherapy drug called~     capecitabine. This sequence of combination chemotherapy before and after radiation therapy,~     and radiation therapy with the drug capecitabine is what is under study. Parts of this~     sequence, for example, the combination of gemcitabine and cisplatin, have shown promising~     results in the treatment of pancreatic cancer. This research study is an attempt to combine~     these various parts.~   "
257722|NCT00176722|"~     Postoperative visual loss resulting from surgical procedures not performed on the eye is a~     devastating outcome for the patient and poorly understood by the medical community. It is~     potentially a preventable complication. Diminished blood supply to the optic nerve, affecting~     both the anterior or posterior portions of the optic nerve, is the most common cause of~     postoperative visual loss. Other, less common causes include occlusion of the retinal artery~     and vein, a retinal embolism and cortical blindness. The incidence of postoperative visual~     loss increases in patients undergoing cardiopulmonary bypass and prone spinal surgery.~     Although the etiology of postoperative visual loss is unknown, it is thought to be~     multifactorial, and several potential risk factors have been identified, including degree of~     low blood pressure, preoperative hematocrit, external compression of the eye, amount of blood~     loss, prolonged duration of surgical time and lying in the face down position. The~     investigators believe this study is a unique opportunity to examine the mechanisms~     responsible for the antecedents to postoperative visual loss (POVL) and ischemic optic~     neuropathy (ION), a devastating complication of (usually) an elective surgical procedure. The~     purpose of this research is to try and determine the potential variables responsible for~     postoperative visual loss which will assist the medical community in devising methods for its~     prevention.~   "
257723|NCT00176696|"~     Reducing postoperative pain leads to increased patient comfort and facilitates speedy~     recovery and discharge from the hospital following surgery. The focus of controlling~     postoperative pain has gradually shifted from postoperative management to intraoperative~     management. The investigators believe that this study is a unique opportunity to assess the~     adequacy of intraoperative analgesia, allowing for immediate administration of the~     appropriate opioid analgesics. The purpose of this research is to bring to light the~     applicability of facial electromyography as an intraoperative solution to postoperative pain~     management.~   "
257724|NCT00176683|"~     The purpose of this study is to assess if capnography can be utilized to assist in the~     process of endotracheal intubation; specifically, in locating the glottic opening. Ultimately~     this would result in a new use of capnography to aid in securing normal and difficult~     airways. Currently capnography is only utilized for the confirmation of endotracheal tube~     placement.~      If successful, this study will provide information, and allow for the development of~     instrumentation that will assist in difficult airway management; specifically, in locating~     the glottic opening when visualization may be impaired. Ultimately, this technique will be~     useful for routine and emergency airway management.~   "
257725|NCT00176670|"~     Preoperative anxiety is characterized by subjective feelings of tension, apprehension,~     nervousness and worry. In children, preoperative anxiety is reported to result in~     postoperative negative psychological effects, including nightmares, separation anxiety,~     eating problems and increased fear of doctors. Anxiety in children can be expressed in many~     forms. Many children look scared, become agitated, breathe deeply, tremble, and stop talking~     or playing and start to cry. They may unexpectedly urinate or may actively attempt to escape~     from the medical personnel. These reactions reflect the child's fear of separation from the~     parents, as well as loss of control, unfamiliar routines, instruments and hospital procedures~     [1].~      Previous studies have assessed anxiety in children during the preoperative period and the~     effects of premedication and parental presence during induction of anesthesia (PPIA) [2].~     Midazolam has been proven to reduce preoperative anxiety in children [3]. Side effects~     related to oral midazolam administered to healthy children are minimal and the drug can be~     reversed with flumazenil but post operative recovery may be delayed in those children~     undergoing a short surgical procedure. It is the experience of the investigator that there~     are some children who have such low levels of anxiety they do not require any intervention~      Distraction may be particularly helpful in children ages 6-12 as these children may not~     receive preoperative medication due to their curiosity about the environment. Previous~     studies regarding distraction therapy have focused on the parent either blowing bubbles or~     reading to a child [4]. Studies where the child is actively engaged in a distraction activity~     have not been documented.~      The purpose of this investigation is to determine whether in the presence of a parent an~     interactive distraction intervention, i.e. Game Boy which is a hand held video game, is as~     effective as preoperative Midazolam in reducing preoperative anxiety. This study may help in~     the search for a low cost and easy to implement method of reducing anxiety for children~     undergoing surgery.~   "
257741|NCT00176462|"~     The purpose of this research study is to identify better ways to treat children and young~     adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define~     methods to identify those patients at higher risk for certain side effects, as well as those~     who are at higher risk for relapse of their leukemia.~   "
257726|NCT00176657|"~     The avoidance of blood transfusions benefits the patient. Cardiopulmonary bypass (CPB) is~     routinely used in complex cardiac surgeries. This device requires circulating blood through~     an oxygenator and pump while the heart is stopped. Upon discontinuation of CPB, the volume of~     blood in the CPB circuit, approximately 1 to 1.5 liters, is currently processed for the red~     cell components of the blood. Yet, all the other blood components are available in this~     volume of blood, but are discarded. The Hemobag filters allow for whole blood reinfusion~     rather than just red cell reinfusion. Thus, the patient’s own platelets, for example, are~     returned to the patient. The product is just being used clinically and we, the investigators~     at University of Medicine and Dentistry, New Jersey, have been asked to perform a study on~     our normal practice (red blood cell return as described above) compared to the whole blood~     return available with the Hemobag™.~   "
257727|NCT00176644|"~     Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer,~     and most recently trials have supported the use of transdermal estrogens (patch) in the~     patient population with a decreased risk of cardiovascular disease as compared to the oral~     estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will~     evaluate the toxicities and measure quality of life. We will assess PSA response and~     measurable disease response. This will be a trial available to the Cancer Institute of New~     Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at~     CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic~     evaluations every three weeks. We will assess quality of life through a questionnaire given~     to patient every three weeks.~   "
257728|NCT00176631|"~     RATIONALE: Licorice root extract contains ingredients that may slow the growth of tumor~     cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     licorice root extract together with docetaxel may be an effective treatment for prostate~     cancer.~      PURPOSE: This phase II trial is studying the side effects and how well giving licorice root~     extract together with docetaxel works in treating patients with metastatic prostate cancer~     that did not respond to hormone therapy.~   "
257729|NCT00176618|"~     The purpose of this study is to determine the effectiveness of curcumin in reducing the~     number of aberrant crypt foci (ACF) in the colon.~   "
257730|NCT00176605|"~     Based on data supporting the use of cyclophosphamide and etoposide both as single agents in~     combination and a Phase I study showing acceptable toxicity with a chronic dosing regimen, we~     propose a Phase II clinical trial. This protocol establishes a model that will test the~     hypothesis that the use of etoposide and cyclophosphamide early in the course of prostate~     cancer progression, when fewer tumor cells are present, will have greater anti-tumor~     activity. We plan to treat patients with stage D0 prostate cancer to assess toxicity and~     anti-tumor activity.~   "
257731|NCT00176592|"~     This is the first comparison of efficacy of Betaseron and Copaxone for treatment of relapsing~     forms of MS.~   "
257732|NCT00176579|"~     RATIONALE: Measuring bone mineral density may help doctors predict whether prostate cancer~     will come back. It may also help the study of prostate cancer in the future.~      PURPOSE: This clinical trial is studying whether bone mineral density affects cancer~     recurrence in patients with early stage prostate cancer.~   "
257733|NCT00176566|"~     You have been asked to participate in this research study because you have or may have oral~     leukoplakia. Oral leukoplakia is described as a white patch or plaque on the oral mucosa~     (mouth) that will not rub off and cannot be removed by scraping, reversed by elimination of~     obvious irritants (things that cause redness and/or swelling) such as dentures (artificial~     replacment for missing teeth), or lesions as described that are diagnosed by your dentist.~   "
257734|NCT00176553|"~     The purposes of this study are to find out whether dextromethorphan can prevent the short or~     long-term neurologic side effects of methotrexate, and whether dextromethorphan can improve~     symptoms of short-term neurologic side effects if they do occur.~   "
257735|NCT00176540|"~     RATIONALE: Dextromethorphan may help relieve fatigue in patients with cancer.~      PURPOSE: This clinical trial is studying how well dextromethorphan works in treating patients~     with fatigue caused by cancer.~   "
257736|NCT00176527|"~     RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to~     grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells.~     Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b~     together with docetaxel and estramustine works in treating patients with metastatic prostate~     cancer that did not respond to hormone therapy.~   "
257737|NCT00176514|"~     This is a clinical research study that is designed to determine if there is a potential~     benefit of green tea to help treat and prevent therapy induced mucositis, which is mouth~     sores caused by chemotherapy.~   "
257738|NCT00176501|"~     RATIONALE: When irradiated donor lymphocytes are infused into the patient they may help the~     patient's immune system kill tumor cells.~      PURPOSE: This phase II trial is studying the side effects and how well giving irradiated~     donor lymphocytes works in treating patients with metastatic kidney cancer.~   "
257739|NCT00176488|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin and vinorelbine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving epirubicin together with vinorelbine may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving epirubicin together with vinorelbine~     works in treating patients with stage II, stage III, or stage IV breast cancer.~   "
257740|NCT00176475|"~     RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may~     help the patient's immune system kill cancer cells. Monoclonal antibodies, such as rituximab,~     can block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Giving irradiated donor lymphocytes together with rituximab may kill more cancer cells.~      PURPOSE: This clinical trial is studying the side effects and how well giving irradiated~     donor lymphocytes together with rituximab works in treating patients with relapsed or~     refractory lymphoproliferative disease.~   "
257742|NCT00176449|"~     The purpose of this study is to examine whether the adjunctive use of bupropion SR in the~     context of a psychoeducational program modified for people with schizophrenia might improve~     the likelihood of successful abstinence in this population. If bupropion SR is effective for~     reducing cigarette smoking, then it will be important to determine if decreased nicotine~     intake is associated with a worsening of psychotic, anxiety or depressive symptoms. In~     addition, it would be important to determine the effect that a reduction in nicotine~     stimulation would have on patient's cognitive functioning, as nicotinic receptors have been~     shown to regulate attention and memory function, and it is hypothesized that these functions~     are normalized by acute nicotine administration in people with schizophrenia~   "
257743|NCT00176436|"~     The study investigates the use of Atomoxetine in combination with exercise and a diet support~     group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All~     patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective~     Disorder.~   "
257744|NCT00176423|"~     The purpose of this study is to examine whether adjunctive galantamine is effective in the~     treatment of cognitive impairments in patients with schizophrenia.~   "
257745|NCT00176410|"~     There is evidence that the degenerative changes leading to aortic stenosis are caused by a~     chronic inflammatory process. Furthermore the development of aortic stenosis is partially~     dependent on typical cardiovascular risk factors. An inflammatory process as well as those~     risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase~     inhibitors) would be an appealing concept to reduce both those risks for development of~     aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the~     progression of aortic stenosis.~   "
257746|NCT00176397|"~     Recent technical advances in percutaneous coronary interventions have made it possible to~     approach patients with coronary lesions formerly considered to be classical candidates for~     bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear~     whether the good long-term results achieved with the surgical therapy can be reproduced by an~     interventional strategy using drug-eluting stents (DES).~      The aim of the current trial is, therefore, to compare the clinical and angiographic results~     of PCI and CABG in patients with left main coronary stenosis.~   "
257747|NCT00176384|"~     Patients with heart failure are limited in their exercise capacity due to skeletal muscle~     alteration and an impairment of peripheral perfusion. Regular physical exercise training has~     been shown to partially correct these peripheral maladaptations in patients with stable heart~     failure, which was associated with an improvement in exercise capacity. However, it is~     unknown so far, whether regular physical activity also exerts beneficial effects in patients~     with severe chronic heart failure.~      Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise~     capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic~     heart failure according to NYHA class III b.~   "
257748|NCT00176371|"~     There is an increasing incidence of overweight children in Germany, due to a lack of physical~     activity.~      The aim of this study is to improve physical fitness and activity in school children. Two~     classes in different schools are provided with additional sport lessons over a period of one~     year.~   "
257749|NCT00176358|"~     The purpose of this study is to compare coronary angioplasty with stent implantation with an~     exercise rehabilitation program in patients with stable coronary artery disease (CAD).~   "
257750|NCT00176345|"~     Bradykinin has been identified to contribute to the release of nitric oxide (NO),~     prostacyclin, and EDHF through activation of specific bradykinin 2 (B2) receptors, which is~     finally promoting a vasodilatory respone. Regular physical exercise training results in an~     improvement of endothelial function in patients with CAD. These positive effects were~     partially attributed to an increased expression of endothelial NO synthase (eNOS) and~     cyclooxygenase (COX) as a result of the training intervention.~      Aim of this trial is therefore to determine, whether the training-induced correction of~     endothelial dysfunction is also bradykinin-dependent.~   "
257751|NCT00176332|"~     Statin therapy has been shown to efficiently reduce mortality in patients with coronary~     artery disease and myocardial infarction, partially as a result of the lipid-lowering~     properties of statins. However, especially the pleiotropic effects of statins, e.g. their~     anti-inflammatory and anti-oxidative properties, might be of interest in the treatment of~     patients with chronic heart failure that are limited in their exercise capacity due to~     alterations of the skeletal muscle and peripheral endothelial dysfunction.~      Aim of this trial is therefore to assess the effects of three months of rosuvastatin~     treatment on markers of inflammation and oxidative stress in the skeletal muscle and the~     blood, on postnatal vasculogenesis, and endothelial function of the radial artery in patients~     with severe chronic heart failure.~   "
257752|NCT00176319|"~     In both ageing and heart failure progressive exercise intolerance is observed. The Leipzig~     Exercise Intervention in Chronic heart failure and Aging (LEICA) study aims to investigate~     how aerobic short-term training interventions affect exercise capacity, left ventricular~     systolic and diastolic function, biomarkers of heart failure, skeletal muscle metabolism, and~     endothelial function in chronis heart failure patients (CHF-patients) and healthy subjects~     (HS) in two different age strata: Above 65 years and below 55 years.~      Aim of the trial is therefore to compare the effects of aerobic exercise training in young~     and old healthy subjects as well as in young and old heart failure patients. To our knowledge~     this study is the first to prospectively investigate age differences of training responses in~     both CHF patients and age-matched healthy controls.~      Because of the extensive clinical and molecular assessment the results of this trial will be~     made public in predefined substudies:~        -  LEICA-Echo~        -  LEICA-Biomarkers~        -  LEICA-Endothelium~        -  LEICA-Cardiopulmonary Exercise Function~        -  LEICA-Muscle~   "
257753|NCT00176306|"~     Obesity is known to affect the concentrations of certain medications in the body.~     Levofloxacin is a commonly used antibiotic. Based on what the investigators know about~     levofloxacin and how it moves through the body, obesity may affect levofloxacin~     concentrations. This study aims to show the effect of obesity on levofloxacin concentrations.~      The hypothesis is as follows: A 750 mg intravenous (IV) dose of levofloxacin administered to~     severely obese, critically ill patients will yield serum concentrations that are likely to be~     therapeutic.~   "
258352|NCT00168389|"~     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone~     for the treatment of diabetic macular edema.~   "
257754|NCT00176293|"~     The primary objective of this study is to assess disease response to Doxil in patients with~     hormone refractory prostate cancer with or without dexamethasone pre-treatment.~      Study Design:~      We will perform an open labeled, parallel, randomized phase II study using a two-stage design~     to determine if there is sufficient anti-tumor activity in either arm to warrant further~     study. Assumptions made in this study: an unacceptable overall response rate is </= 10% & we~     will pursue further study if the overall response rate is >/= 30%. Fifteen patients will be~     randomized in the first phase (to both Arm 1 and Arm 2). No further patients will be accrued~     if <2/15 responses are noted in a given arm. Ten additional patients will be enrolled if >/=~     2/15 responses are observed. If there are >/= 5/25 responses then further studies will be~     pursued with that regimen. We will determine the overall incidence & severity of toxicities~     in both arms.~      Treatment:~      Arm 1: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 2: Doxil:~     Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 1 only: Dexamethasone:~     Dose: 12 mg twice a day by mouth on days 1, 2, 3, 4, 5 of each 28 day cycle.~      Number of Cycles for both Arm 1 & 2: until progression or unacceptable toxicity develops.~   "
257755|NCT00176280|"~     -Overall study design: A randomized Phase II study in patients with metastatic RCC Patients~     will receive chemotherapy with gemcitabine and 5-FU. Prior to each chemotherapy the patient~     will receive a combination of Leukine alone (study cohort 1) or Leukine-dexamethasone (study~     cohort 2).~      -Chemotherapy: gemcitabine 1.0 g/m2 intravenously (infused in the vein)over 30 minutes on~     Days 7 and 21, Folinic acid 200 mg/m2 on Days 7-8 and 21-22, then 5-FU 400 mg/m2,~     intravenously (infused in the vein) over 30 minutes followed by 5-FU 600 mg/m2 intravenously~     (infused in the vein) over 24 hours.~      •Study drugs:~        -  Cohort 1, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin) on days 1, 2,~          3, 4, 5 and 15, 16, 17, 18, and 19;~        -  Cohort 2, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin)on days 1, 2,~          3, 4, 5, and 15, 16, 17, 18, and 19 and dexamethasone 12 mg every 12 hours (8 am and 8~          pm) orally (by mouth) on days 3, 4, 5, 6, 7, 17, 18, 19, 20, and 21.~   "
257756|NCT00176267|"~     This study is being performed utilizing two cycles of Paclitaxel and Carboplatin, plus low~     doses radiation as initial therapy prior to other treatment (surgery or radiation). The study~     is assessing if utilization of low doses radiation as a chemoenhancer will further increase~     the response rate seen with initial therapy.~   "
257757|NCT00176254|"~     This study utilizes two cycles of Paclitaxel and Carboplatin chemotherapies followed by four~     small doses of radiation, prior to other treatment (surgery or radiation). This study is~     evaluating if radiation as a chemoenhancer increases the response rate of initial therapy.~   "
257758|NCT00176241|"~     This study seeks to establish the safety of gemcitabine, paclitaxel and low-dose radiation in~     recurrent, metastatic head and neck cancer through a two-stage dose escalation study, first~     with Gemcitabine dose escalation and then with low-dose radiation escalation.~      Treatment Schedule~      Treatment will be administered on an inpatient or outpatient basis.~        -  Gemcitabine:2000 to 3000mg/m2 IV (in the vein) on days 1 and 15 every 28 days over 30-60~          minutes.~        -  Paclitaxel: 150 mg/m2 IV(in the vein)on days 1 and 15 every 28 days over 60 minutes.~        -  Low Dose Radiation: 50-80 cGy twice daily on days 1, 2, 15, & 16 every 28 days at least~          4 hours apart.~   "
257759|NCT00176228|"~     There are two purposes for this project. Study 1 is intended to study the safety and efficacy~     of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases:~     mixed, manic, hypomanic, or depressed episodes) in 8-17 year old children. These children and~     adolescents must be treatment resistant (who failed on two adequate trials of mood~     stabilizing medications) to qualify for this study. Study 2 is aimed at examining brain~     activity and/or dysfunction before lamotrigine treatment, and to look for any alteration~     after lamotrigine treatment. Brain systems associated with attention and emotional processing~     will targeted.~   "
257760|NCT00176215|"~     The aim of this prospective clinical trial was to investigate the clinical performance and~     complication rate of RPDs (Removable partial dentures) retained on conventional conical~     double crowns in comparison to galvanoformed telscopic double crowns. Additionally the OHIP~     (Oral Health related Qualitiy of Life)and the abrasion of the teeth were investigated.~   "
257761|NCT00176202|"~     The study is to examine the null hypothesis that risperidone and divalproex sodium are~     equally effective in treating/stabilizing pediatric bipolar disorder.~   "
257762|NCT00176189|"~     Fixed-partial dentures fabricated of zircon-oxide ceramics were introduced in dentistry some~     time ago. However, the survival rate of all-ceramic extended (up to 47mm) fixed-partial~     dentures is unknown.~      The hypothesis was that long FDPs fabricated of zirkon-oxide withstand masticatory forces in~     the posterior and anterior regio of the jaw.~   "
257763|NCT00176176|"~     In this study, changes in electroencephalogram (EEG) and the hemodynamic state during~     ventricular fibrillation or induced ventricular tachycardia are investigated.~   "
257764|NCT00176163|"~     It is known, that a so called pain memory usually evolves in chronic pain syndromes which~     both aggravates the disorder and modifies the patients pain perception. Thus, the principal~     object of pain therapy is to delete this dysfunctional pain memory. The combination of~     medication, physiotherapy and psychological therapy seems to be the most effective treatment.~     This study investigates the effect of a concomitant Dronabinol medication (Cannabinoid) on~     the effectiveness of behavioral therapy. It is hypothesized that the combination of~     behavioral therapy and Dronabinol will be most effective in deleting the pain memory.~   "
257765|NCT00176150|"~     The aim of this study is to investigate whether patients with anorexia nervosa have elevated~     plasma cholesterol levels and, if elevated plasma cholesterol levels influence drug transport~     by the ABC-transporter P-gp (P-glycoprotein, MDR 1/ABCB1). We will isolate peripheral blood~     mononuclear cells (PBMCs) and total RNA from the blood of patients with anorexia nervosa and~     healthy subjects as control. PBMCs will be used for quantitative cholesterol determination~     and for measuring the activity of P-gp using a FACS (fluorescence-activated cell sorting)~     method (rhodamine123 efflux). Total RNA will be used for quantitative expression analysis of~     P-gp by reverse transcriptase real time PCR.~   "
257814|NCT00175513|"~     This is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an~     antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis, a~     form of a mental disorder.~   "
257766|NCT00176137|"~     Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by~     hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery~     and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide,~     followed by surgery and then RT.~      The primary endpoint was progression free survival (PFS). With 500 patients evaluable an~     improvement of median PFS from 10 to 14 months could be detected.~   "
257767|NCT00176124|"~     Leukocyte depletion of autologous whole blood prior to storage does not reduce infection rate~     (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay but~     may increase retransfusion perioperatively during hip arthroplasty and allogenic transfusion~     rate~   "
257768|NCT00176111|"~     In this study we want to examine the effect of a small amount of local anesthetic or saline~     solution on nerve conduction using a peripheral nerve stimulator.~   "
257769|NCT00176098|"~     Perioperative stress for cataract surgery in the elderly is considerable even in the absence~     of pain. For these patients with a high comorbidity level, the perioperative situation~     comprising factors such as uncomfortable positioning, dull ambience, face cover, poor~     sedation, and anxiety might not only reduce intraoperative compliance but induce cardiac~     ischemia and hypertensive crises. Hypnosis is supposed to increase patient comfort, to shield~     the patient from organic stress and to improve intraoperative compliance without side effects~     even in old and very ill patients. In a controlled study, we, the investigators at the~     University of Heidelberg, compared phakoemulsification under topical anesthesia as usual (and~     placebo hypnosis) with either additional hypnosis or hypnoanalgesia without topical~     anesthesia.~   "
257770|NCT00176085|"~     A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to~     now not conducted, except of one single experiment in which (lacking) psychopharmacological~     activity was tested after intravenous infusion of 20 mg in a human individual. In this study,~     however, the authors did not trace the above questions due to analytical and methodological~     deficits.~      Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after~     intravenous ad-ministration of 5 mg THCCOOH in healthy individuals~   "
257771|NCT00176072|"~     Bioavailability of methylene blue (MB) - comparison of an i.v. and two oral MB formulations -~     and influence of sustained release MB on chloroquine (CQ) concentrations in whole blood,~     plasma and urine.~      Intraindividual cross over open comparison in healthy male and female individuals (6:6) with~     different MB formulations in randomised order for the determination of the absolute~     bioavailability of MB (part 1), followed by an explorative randomised parallel group~     comparison of CQ disposition when CQ is given alone (3 males and 3 females) or in combination~     with 1000 mg sustained release MB (3 males and 3 females) in the participants of study part 1~     (part 2).~   "
257772|NCT00176059|"~     The aim of this randomized prospective study in renal transplant recipients is to investigate~     immunological short and long-term effects of an IVIG induction therapy.~      Furthermore clinical endpoints (patient and graft survival, incidence of acute and chronic~     rejection, infectious diseases and graft function) up to three years posttransplant will be~     analyzed.~   "
257773|NCT00176046|"~     The purpose of this feasibility study is to identify appropriate surrogate parameters for a~     randomized study to examine the efficacy of a complementary therapy with an extract of viscum~     album (Iscador P) in patients with breast cancer.~   "
257774|NCT00176033|"~     The aim of this study is to determine the pharmacokinetics of Kaletra™ (HIV protease~     inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of~     four different drug transporters (MDR, MRP1, MRP2 and BCRP) in the tissue distribution of the~     two protease inhibitors. The latter will be studied by comparing intracellular concentrations~     of peripheral blood mononuclear cells (PBMCs) with total and free plasma concentrations in~     healthy individuals. These effects will be studied after single dose (day 1), during steady~     state (day 3), and during chronic treatment (day 14).~   "
257775|NCT00176020|"~     The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment,~     3-­way crossover. Subjects will be randomly allocated to a treatment sequence – AAB, ABA or~     BAA. The two treatments will be:~        -  Treatment A: 500 mg nicotinic acid (Niacor(R))~        -  Treatment B: Niacor(R) Placebo~      Each trial period will last one day, there will be a wash-out period of at least 2 days~     between each trial period. Five to seven days after study day 1 of trial period 3 there will~     be a final safety examination.~   "
257776|NCT00176007|"~     Aim of the study is to investigate the function of the systemic vascular endothelium in~     individuals susceptible to high-altitude pulmonary oedema during normoxia and normobaric~     hypoxia.~   "
257777|NCT00175994|"~     The purposes of this study are:~        -  To determine the absolute bioavailability of voriconazole after a single oral dose (400~          mg voriconazole [VFEND brand]) in comparison to intravenous (i.v.) administration (400~          mg VFEND, equivalent to two 10 mg/ml-infusates, each containing 200 mg voriconazole~          [VRC]) in healthy individuals stratified according to the three predominant CYP2C19~          genotypes~        -  To investigate the possible pathways of metabolism and their modulation according to~          genetic polymorphism of CYP2C19 after i.v. and oral administration of VRC.~   "
257778|NCT00175981|"~     Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its~     effect on the venous response to sodium nitroprusside.~   "
257779|NCT00175968|"~     Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric~     nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.~   "
257780|NCT00175955|"~     An 8-week study to examine safety and efficacy of levetiracetam in patients with~     neuroleptic-induced tardive dyskinesia~   "
257781|NCT00175942|"~     Sudden cardiac death is in most cases triggered by ischemia-related ventricular~     tachyarrhythmias and accounts for 50% of deaths from cardiovascular disease in developed~     countries. Chronic elevation of indicators of coagulation activation has been found in~     patients with coronary heart disease , but a role of coagulation activation and~     proinflammatory state as a potential risk factor for ventricular fibrillation (VF) during~     acute myocardial infarction has not been investigated.~   "
257782|NCT00175929|"~     This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150~     mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy~   "
263320|NCT00102154|"~     A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a~     sleep disorder).~   "
257783|NCT00175916|"~     This trial, evaluating the long-term safety and tolerability of brivaracetam, will give~     subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity~     to continue the treatment. The study will also evaluate the maintenance of efficacy over time~     of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures~     (PGS).~   "
257784|NCT00175903|"~     Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam~     (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release~     (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with~     newly diagnosed epilepsy.~   "
257785|NCT00175890|"~     To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in~     pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects~     will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an~     evaluation). Other neuropsychological clinical assessments will be performed during the 34~     day length of the study.~   "
257786|NCT00175877|"~     An open ended study in which patients who completed the double-blind study CDP870-027~     [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of~     Rheumatoid Arthritis (RA).~   "
257787|NCT00175864|"~     This is a safety and efficacy study of add on therapy with seletracetam in patients~     experiencing refractory epilepsy.~   "
257788|NCT00175851|"~     This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients~     who have participated in a previous seletracetam study~   "
257789|NCT00175838|"~     The purpose of this trial is to see if Hydroxyurea + aspirin is a better treatment than~     aspirin alone for Intermediate Risk Primary Thrombocythemia (PT) patients.~   "
257790|NCT00175825|"~     This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50~     mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.~   "
257791|NCT00175812|"~     Hypothesis: Differentiation induction therapy in acute myelogenous leukemia (AML) can be used~     to achieve disease control and stabilize peripheral blood counts in patients with acute~     myelogenous leukemia.~      Adult patients (<18 years of age) who can be included: Elderly patients (>60 years of age)~     with newly diagnosed AML who cannot achieve standard chemotherapy, patients with relapsed or~     resistant AML. Patients with relapsed or resistant AML who cannot receive intensive~     chemotherapy.~      Treatment: Patients will be treated with all-trans retinoic acid (oral administration),~     valproic acid (7 days intravenous administration and later oral administration)and~     theophyllamine (7 days intravenous administration and later oral administration). Duration of~     treatment at least 2 months or until disease progression. Maximal duration of treatment 2~     years.~      Followup: Clinical evaluation, peripheral blood samples, bone marrow samples.~   "
257792|NCT00175799|"~     This is a study of the validation of severity of illness scoring systems in Paediatric~     Intensive Care Units (PICUs) in Canada.~   "
257793|NCT00175786|"~     The purpose of this study is to study the occurrence rate of masses such as brain tumors in~     patients with newly diagnosed Normal Tension Glaucoma.~   "
257794|NCT00175773|"~     The primary purpose of this study is to investigate the relationship between the extent of~     neurologic (nerve) impairment in patients with spinal cord injuries and how well the nerves~     passing down the spine to the heart and blood vessels are working. These nerves are called~     the descending spinal sympathetic pathway (DSSP) and are important in controlling many~     functions, including blood pressure. We also wish to examine how injury severity and DSSP~     function influence blood levels of nor-epinephrine and epinephrine. Nor-epinephrine and~     epinephrine are hormones released into the blood that are also important in controlling blood~     pressure. Thus, we will also look at how the effect of the extent of DSSP dysfunction~     influences heart rate and blood pressure and blood levels of certain enzymes.~   "
257795|NCT00175760|"~     This study is to see if a high response to the TTG screening test for celiac disease is as~     accurate as the current method of diagnosing celiac disease which entails a general~     anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening~     blood test is highly accurate, then some patients that are being evaluated for celiac disease~     may not require an upper GI endoscopy and can be treated more quickly. If they respond to the~     therapy then they will be deemed to have celiac disease.~   "
257796|NCT00175747|"~     Studies in animals suggest that inhaled budesonide may prevent the occurrence of lung cancer.~     We conducted a clinical trial to determine the effects of inhaled budesonide in smokers who~     had precancerous lesions in the breathing tubes (i.e. bronchial dysplasia.~   "
257797|NCT00175734|"~     The purpose of this study is to document relevant and related clinical changes associated~     with different hemoglobin concentrations in diabetic hemodialysis patients.~      Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin~     concentrations in diabetic hemodialysis patients.~   "
257798|NCT00175721|"~     The purpose of this study is to assess the benefits of a combined cardiac, kidney, and~     diabetes clinic versus multiple clinics.~      Hypothesis: Attendance at multiple clinics by one individual patient has multiple problems~     which may be overcome by the introduction of a combined care clinic.~   "
257799|NCT00175708|"~     The purpose of this study is to determine the utility of pedobarographs in evaluating~     clubfoot post-treatment.~   "
257815|NCT00175500|"~     About ten percent of revision hip replacements will dislocate. Although dislocation is not a~     life-threatening problem, it is stressful and costly and requires hospitalization to treat.~     Subjects who have repeated dislocations live with the constant fear of another dislocation.~     The purpose of this study is to test the effectiveness of a large ball prosthesis in~     preventing post-surgical dislocation. A large diameter ball has greater freedom of movement~     before it impinges; therefore, theoretically, it should not dislocate as easily.~   "
257816|NCT00175487|"~     This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip~     system. This is a prospective randomized trial.~   "
257817|NCT00175474|"~     Comparison of a minimally invasive technique for total knee replacement to a standard~     technique~   "
257818|NCT00175461|"~     Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral~     approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches~     in primary total hip arthroplasty~   "
257800|NCT00175695|"~     Short description of the primary purpose of the protocol intended for the lay public. Include~     brief statement of study hypothesis~      Pre-eclampsia (toxemia of pregnancy) is the most cause of death among pregnant women in North~     America. It also causes many complications for fetuses (unborn children) and neonates~     (newborn children). Pre-eclampsia is defined by high blood pressure (hypertension), the loss~     of protein into the urine (proteinuria), and disorders of many body systems, including the~     blood clotting (coagulation) and inflammation. What is needed is a compound that will safely~     prolong pregnancies, to give babies more time to grow inside their mothers, and will help the~     recovery in those mothers after delivery.~      We are going to investigate a compound (recombinant human activated protein C (rhAPC)) that~     has the potential to modify disease activity in pre-eclampsia by reducing coagulation and~     inflammation disorders. rhAPC is effective in patients suffering from septic shock. We will~     test rhAPC in women who develop severe pre-eclampsia in two ways. First, in women with severe~     pre-eclampsia remote from term who are carrying small babies (intent: safely prolong their~     pregnancies). Second, in women who have had severe pre-eclampsia before their baby delivered~     (including women in the first group), or whose disease develops/worsens after delivery~     (intent: switch off the disease so dangerous complications do not arise).~      This study is a preliminary one to look for possible risks and benefits for these women. Only~     40 women will be studied to provide initial evidence on which to base a larger international~     trial which is planned. We will study their pregnancy outcomes as well as markers of disease~     activity, to gain a better understanding of the mechanisms by which these women become~     unwell.~   "
257801|NCT00175682|"~     Sexuality is a high rehabilitative priority for persons following a spinal cord injury (SCI).~     Sexual acts can lead to autonomic dysreflexia (AD), dangerous consequences such as a sudden~     increase in blood pressure, severe headache, sweating above the level of the lesion and low~     heart rate to name a few. Ejaculation in men can provoke these significant symptoms and~     therefore men and women may refrain from a sexual life and biological parenthood. Adalat is~     the most common antihypertensive used in fertility clinics to reduce the incidence of AD. It~     dramatically reduces blood pressure and, therefore, results in side effects such as~     dizziness, fatigue and weakness. The investigators hypothesize that Minipress® (prazosin~     HCL), a blood pressure medication, which has a slower and less abrupt suppressive effect on~     blood pressure, would be a safe, effective and more appropriate medication for use in the~     outpatient sperm retrieval clinic and potentially for private use.~   "
257802|NCT00175669|"~     The purpose of this study is to compare the effect of Botox and casting to placebo and~     casting for reducing toe walking problems in children who are idiopathic toe walkers.~   "
257803|NCT00175656|"~     Titanium elastic nails in the pediatric femoral fractures: A prospective randomized clinical~     trial of eliminating nail protrusion to decrease soft tissue complications~   "
257804|NCT00175643|"~     It is believed that imiquimod 5% cream has the potential to be an effective treatment for~     actinic keratoses. The purpose of this study is to evaluate the duration of the effect of~     topical imiquimod 5% topical cream for the treatment of actinic keratoses.~   "
257805|NCT00175630|"~     This study evaluates the effect of a femoral nerve block on opioid requirements following~     anterior cruciate ligament (ACL) reconstruction. This is a double blind, prospective~     randomized controlled trial.~   "
257806|NCT00175617|"~     This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared~     to topical minoxidil in female pattern hair loss.~   "
257807|NCT00175604|"~     The primary purpose is to investigate the effect of Botox on the treatment of congenital~     muscular torticollis (CMT). The investigators' hypothesis is that a Botox injection will be~     an effective treatment when used in conjunction with current treatment procedures.~   "
257808|NCT00175591|"~     This study evaluates the effect of a femoral nerve block on opioid requirements following~     femoral fracture fixation with flexible nails in the paediatric population. This is a double~     blind, prospective randomized clinical trial.~   "
257809|NCT00175578|"~     Promising new technology exists to examine small proteins that are shed by cancers into the~     blood stream. The purpose of this study is to see if there are differences in the proteins~     and protein levels in blood from individuals with early stage lung cancer compared to healthy~     adults.~   "
257810|NCT00175565|"~     Systemic inflammation is present in chronic obstructive pulmonary disease (COPD), which has~     been linked to cardiovascular morbidity and mortality. We determined the effects of oral and~     inhaled corticosteroids on serum markers of inflammation in patients with stable COPD.~   "
257811|NCT00175552|"~     Evaluating the Effectiveness of Different Interpersonal Psychotherapy for Adolescents (IPT-A)~     Therapist Training Models~   "
257812|NCT00175539|"~     The purpose of this study is to pilot test and determine the feasibility of a~     psychoeducational intervention (PED) we recently developed in a group format for women with~     acquired sexual arousal disorder (FSAD).~      HYPOTHESES:~        -  1 - Compared to baseline measures, the PED will result in significant improvement in~          self-report measures of: (a) subjective sexual arousal; (b) perception of genital~          arousal/genital sensitivity; (c) orgasmic experience; (d) sexual desire; (e) sexual~          distress; (f) relationship satisfaction; (g) depressive symptoms; and (h) quality of~          life.~        -  2 - It is unknown what effect the PED will have on actual physiological sexual arousal.~        -  3 - The group format will be a feasible and cost-effective method of delivering~          empirically supported treatment to women with sexual arousal difficulties and will~          contribute towards meeting the needs for sexual health care for women on the clinic~          wait-list at the BC Centre for Sexual Medicine.~   "
257813|NCT00175526|"~     At present, the management of pre-eclampsia is guided by expert opinions that are not~     well-based on firm evidence. What is required is a clinical tool that can accurately~     determine a women's risk for adverse outcomes, and thereby reduce the risk for women while~     safely prolonging pregnancies remote from term (to improve fetal outcomes). This research~     project, 'a severity score for pre-eclampsia,' will develop such a clinical tool that is~     specific to the condition. This severity score will be used clinically (to guide management)~     and in research (in both clinical trials and basic science research), and will provide an~     evidence base on which to build future practice, improving outcomes for pregnant women and~     their babies. In addition, this project is part of a three part strategy to better understand~     the mechanisms of disease in pre-eclampsia and to investigate a potential disease-modifying~     therapy, namely, recombinant human activated protein C.~   "
257821|NCT00175422|"~     This research project seeks to implement an early intervention program that can be effective~     in the prevention of shaken baby syndrome (SBS) and infant abuse. The investigators'~     hypothesis is that the Period of PURPLE Crying intervention program can be effective in~     reducing the shaking and abuse of infants through changes in knowledge, attitudes and~     behaviours about early infant crying, especially inconsolable crying.~   "
257822|NCT00175409|"~     The purpose of this study is to compare the effects of mothers' breastfeeding with the~     effects of pacifier sucking on preterm infant biobehavioural responses during and immediately~     after a painful procedure~      Hypothesis:~        1. When breast fed by their mothers during blood collection, preterm infants will show less~          pain reaction than when sucking on a pacifier.~        2. Following breast feeding during the blood collection, mothers will find no differences~          in their infants' breast feeding ability.~   "
257823|NCT00175396|"~     The purpose of this trial is to compare two similar treatments for patients diagnosed with~     prostate cancer. The two treatment arms being compared are: (Standard Arm) hormone therapy,~     which will prevent the production of the male hormone, testosterone, by the testicles, and~     pelvic external beam radiation therapy (EBRT) followed by a high-dose, conformal EBRT boost~     versus (Investigational Arm) hormone therapy and pelvic EBRT followed by a brachytherapy~     boost (implantation of radioactive iodine sources or seeds into the prostate).~      The hypothesis of this trial is that more patients may experience 5 year actuarial freedom~     from biochemical recurrence of their prostate cancer following treatment with the~     investigational arm. Biochemical failure is declared on the date when the post treatment~     prostate specific antigen (PSA) is > 2 ng/mL above the lowest level previously recorded.~   "
257824|NCT00175383|"~     Brachytherapy, or Transperineal implantation of the prostate (TPIP), is a recognized form of~     treatment for localized cancer of the prostate. TPIP has been used at the British Columbia~     Cancer Agency (BCCA) since 1998. As part of the treatment, some patients also require hormone~     therapy for 6 months. This is given as injections of a drug called an LHRH agonist. The LHRH~     agonist is made either as short-acting (1-month) or long-acting (3 month) injections. The~     LHRH agonist lowers testosterone levels, which helps make delivery of TPIP easier, and more~     effective.~      There are specific guidelines regarding the use of LHRH agonist treatment with brachytherapy,~     however there is no policy whether short-acting or long-acting LHRH agonists should be used.~      Analysis of results from BC has shown that there seems to be a delay in the time in which~     testosterone levels return to normal in men who receive the long-acting LHRH agonist compared~     with the short-acting LHRH agonist, however this is not known for sure.~   "
257825|NCT00175370|"~     Patients admitted into the Intensive Care Unit (ICU) have an intravenous (IV) catheter (small~     plastic tube) placed in their vein. Very occasionally (4 times out of 100) the insertion of~     an intravenous catheter may cause an infection in the blood. It has been shown that the~     removal of the catheter and the insertion of a new one at a new site helps to get rid of this~     infection. Sometimes, antibiotics are also given.~      Vancomycin is the antibiotic given intravenously (into the vein) to treat these~     catheter-related infections. At Vancouver General Hospital, some physicians may not give any~     vancomycin at all whereas others may treat with intravenous (IV) vancomycin for one to~     fourteen days.~      Since there are a lack of data to support the length of IV vancomycin therapy, the~     investigators would like to find out if two days of IV vancomycin are as good as seven days.~      Therefore, the purpose of this study is to determine if two days of IV vancomycin are as good~     as seven days for the treatment of catheter-related infections in the blood.~   "
257826|NCT00175357|"~     The objective of this study is to determine whether the closely supervised provision of~     injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more~     effective than methadone therapy alone in recruiting, retaining, and benefiting long-term~     heroin users who have not been helped by current standard treatment options.~   "
257827|NCT00175344|"~     All patients undergoing breast cancer surgery are left with scars which can significantly~     affect their physical and psychological well being. Patients with breast cancer, motivated to~     optimize healing and function, have inquired about the advisability of scar massage after~     surgery. Although this is a popular technique advocated by physiotherapists and massage~     therapists to improve pain, range of motion, and scar pliability, there is currently no~     scientific research to prove the benefits and/or risks of scar massage in breast cancer~     patients. We propose to study the effect of scar massage on pain, arm function, scar~     formation, and quality of life in patients with breast cancer. Patients who have had breast~     cancer surgery and who have been referred to the BC Cancer Agency, Vancouver Island Centre~     will be offered participation in this research study. To objectively evaluate the effects of~     scar massage, those who agree to participate will be randomly assigned to one of two groups.~     One group will be taught to perform self-massage of the scars as soon as the scars have~     adequately healed. The massage should be done about 10 minutes each day for a total of 6~     months. The other group will not be taught self-massage and will be asked to not massage~     their breast scars. In both groups, we will monitor pain, upper body range of motion, scar~     characteristics and quality of life using standardized criteria for 2 years from the time of~     surgery. Problems with infections or blood or fluid accumulation at the scar areas will also~     be monitored. After 2 years, the information collected will be analyzed and compared to see~     if there are differences in pain, function or quality of life between the two groups. The~     results from this study will provide scientific proof of whether or not scar massage after~     surgery is beneficial for patients with breast cancer.~   "
257828|NCT00175318|"~     Dental decay is an alarming problem in Cree children. The intervention is a behavioural~     counseling approach called Motivational Interviewing (MI). The dental health of young~     children in communities whose mothers had a series of MI sessions provided by Cree women will~     be compared to the dental health of mothers who did not have the intervention.~   "
257829|NCT00175305|"~     Excessive weight gain is a cardinal feature of Prader-Willi syndrome (PWS) for which there is~     presently no effective treatment. It is caused by increased appetite, decreased perception of~     satiety and obsessive and compulsive behaviour towards food. Ghrelin is a powerful~     appetite-stimulating hormone. Patients with PWS have markedly elevated ghrelin levels,~     suggesting that it may be responsible for the increased food intake. The goal of the study is~     to determine whether treatment with somatostatin (Sandostatin), a hormone that inhibits~     ghrelin, is an effective treatment for the prevention and treatment of weight excess in~     patients with PWS.~   "
257830|NCT00175292|"~     This randomized placebo-controlled double-blind, multi-centre trial will determine the~     efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following~     surgical resection and re-anastomosis. A total of 120 patients will be randomly assigned in a~     1:1 ratio to receive VSL#3 or placebo for 90 days. Patients who respond to study treatment,~     as defined by the absence of a severe endoscopic recurrence at day 90, will be offered~     open-label VSL#3 for an additional 9 months.~   "
258948|NCT00160511|"~     16 week trial assessing the efficacy, safety, and tolerability of levetiracetam compared with~     placebo in the treatment of postherpetic neuralgia.~   "
257831|NCT00175279|"~     BACKGROUND: Although much has been written about the influence of local opinion leaders on~     clinical practice, there have been few controlled studies of their effect, and almost none~     have attempted to change prescribing in the community for chronic conditions such as~     congestive heart failure (CHF) or ischemic heart disease (IHD). These two conditions are~     common and there is very good evidence about how to best prevent morbidity and mortality -~     and very good evidence that quality of care is, in general, suboptimal. Practice audits have~     demonstrated that about half of eligible CHF patients are prescribed ACE inhibitors (and~     fewer still reaching appropriate target doses) and less than one-third of patients with~     established IHD are prescribed statins (with many fewer reaching recommended cholesterol~     targets). It is apparent that interventions to improve quality of prescribing are urgently~     needed.~      HYPOTHESIS: An intervention that consists of patient-specific one-page evidence summaries,~     generated and then endorsed by local opinion leaders, will be able to change prescribing~     practices of community-based primary care physicians.~      DESIGN: A single centre randomized controlled trial comparing an opinion leader intervention~     to usual care. Based on random allocation of all physicians in one large Canadian health~     region, patients with CHF or IHD (not receiving ACE inhibitors or statins, respectively)~     recruited from community pharmacies will be allocated to intervention or usual care. The~     primary outcome is improvement in prescription of proven efficacious therapies for CHF (ACE~     inhibitors) or IHD (statins) within 6 months of the intervention.~   "
257832|NCT00175266|"~     Islet transplantation has been investigated as a treatment for Type 1 diabetes mellitus in~     selected patients with inadequate glucose control despite insulin therapy. However, the~     perennial hope that such an approach would result in long-term freedom from the need for~     exogenous insulin, with stabilization of the secondary complications of diabetes, has failed~     to materialize in practice. The goal of the present study is therefore to improve the safety~     and efficacy of clinical islet-alone transplantation by minimizing dependence on~     calcineurin-inhibitor therapy - thereby avoiding potential nephrotoxicity, and furthermore~     improving success with single-donor islet infusions by avoiding all diabetogenic~     immunosuppression. Campath-1H, combined with Infliximab induction therapy provides a unique~     opportunity to minimize dosing of maintenance long-term immunosuppression while further~     promoting islet engraftment.~   "
257833|NCT00175253|"~     Our experience suggests that further research with alemtuzumab is attractive in islet~     transplantation. Therefore, in this study we propose to combine alemtuzumab induction~     pre-transplant, with tacrolimus and mycophenolate mofetil maintenance immunosuppression~     post-transplant. In the critical early phase post transplant, we anticipate that this regimen~     will prove to be more effective in control of autoimmunity or rejection events, and have a~     more desirable side-effect profile, than previously tested combinations of induction and~     immunosuppressive agents.~   "
257834|NCT00175240|"~     People with coronary artery disease can reduce their chance of having a heart attack by~     making healthy lifestyle choices (diet, exercise, quitting smoking,etc.). There are also many~     medications that have been proven to reduce the risk of heart attacks and may even help~     people live longer. This study will look at different ways of improving the use of these~     beneficial medications to enhance the quality of care for people with this condition.~   "
257835|NCT00175227|"~     Patients with pre-existing kidney disease are at high risk of acute renal failure when~     exposed to radio-contrast dyes, for example during a cardiac angiogram.~      The investigators hypothesize that an infusion of saline + furosemide + mannitol will reduce~     rates of contrast-induced nephropathy when compared with saline infusion controls.~   "
257836|NCT00175214|"~     The primary objective of this proposed research is to improve the quality of care for~     patients who present to the Emergency Department with osteoporosis and a fracture of the~     wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the~     primary study outcome, and it is defined as starting any one of hormone therapy, a~     bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.~      The study hypothesis is that a quality improvement intervention (with multiple components~     that include a notification system for primary care physicians, patient-specific reminders,~     locally generated treatment guidelines endorsed by opinion leaders, and patient education and~     counseling) will lead to increased use of proven efficacious osteoporosis treatments in~     patients eligible for secondary prevention. This hypothesis will be tested by comparing the~     intervention with usual care controls, in a prospective nonrandomized controlled trial.~   "
257837|NCT00175201|"~     In this randomised study a proactive care and rehabilitation intervention is compared to the~     current care and rehabilitation in patients undergoing primary hip and knee replacement~     surgery.~      A cost efficacy analysis in a societal perspective is made from effect data in the randomised~     controlled study together with cost data gathered during the perioperative and postoperative~     period.~      If the proactive care and rehabilitation intervention is cost effective the intervention is~     going to be implemented in Ringkøbing County. This implementation proces is measured within a~     monitoring project of all patients receiving hip or knee replacement surgery in Ringkøbing~     County in the period 2003 to 2007.~   "
257838|NCT00175188|"~     The purpose of this study is to compare the early migration and the periprosthetic bone~     changes of cemented versus non-cemented interphalangeal implants using Roentgen~     stereophotogrammetric analysis and dual energy x-ray absorptiometry (DEXA). Furthermore, a~     thorough occupational therapist evaluation on the functional progress prior to and after~     surgery will be assessed.~   "
257839|NCT00175175|"~     Patients with hip fractures have suffered the most devastating consequence of osteoporosis;~     and yet, they are rarely if ever tested or treated for the condition, even though they remain~     at high risk of recurrent fracture.~      We hypothesize that, compared with usual care, an allied health professional-run osteoporosis~     service (case management) will be able to increase testing and treatment of osteoporosis in~     patients at high risk of fracture.~   "
257840|NCT00175162|"~     The purpose of this study is to compare the early migration and periprosthetic bone changes~     of two total knee arthroplasties fixated with two different type bone cement.~   "
257841|NCT00175149|"~     Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of~     LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In~     the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to~     study the effect on LVH.~   "
257842|NCT00175136|"~     The purpose of this study is to compare the early migration and periprosthetic bone changes~     of two cemented total knee arthroplasties with different tibial stem design. Only the tibial~     prostheses plateau varies in that one is an wedge-shaped stem and the other is a I-shaped~     stem.~   "
257843|NCT00175123|"~     The purpose of this study is to examine how injection of botulinum toxin in the bladder~     affects bladder function. The trial is carried out in children born with malformation of the~     spinal cord and subsequent overactive bladders. The purpose of treating the bladder (with~     different drugs) is to prevent damage to the kidneys and renal function. The aim of this~     study is to compare a conventionally used drug (oxybutynin) with botulinum toxin. The~     hypothesis of the study is that botulinum toxin is equal to oxybutynin in the treatment of~     overactive bladder.~   "
257844|NCT00175110|"~     The goal of this study is to find out whether the plant compounds present in Hibiscus~     sabdariffa, a plant commonly used in herbal tea blends and other beverages, will have a~     beneficial effect on blood pressure in people with mildly elevated blood pressure.~   "
257845|NCT00175097|"~     To evaluate the impact of soybean processing as well as the effect of soy relative to animal~     protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors~     in hypercholesterolemic subjects.~   "
257846|NCT00175084|"~     The aim of this study is to explore the significance of the Lys:Arg ratio on responses of~     lipids and lipoprotein concentrations to dietary proteins and to evaluate the effects of~     dietary Lys:Arg on cardiovascular disease risk factors and endothelial function.~   "
257847|NCT00175071|"~     The current study is designed to assess the effect of a conventional cooking oil~     (hydrogenated oil) and a reformulated fat low in trans fatty acids on cardiovascular disease~     risk factors.~   "
257848|NCT00175058|"~     To determine whether or not HyperOxemic therapy rendered to patients (that meet the study~     inclusion criteria) with anterior acute myocardial infarction < 6 hours from symptom onset to~     reperfusion, results in a significant reduction in infarct size as measured by SPECT @ 14~     days post event.~   "
257849|NCT00175045|"~     The purpose of this study was to compare the pharmacodynamics of intravenous (IV)~     lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive~     esophagitis.~   "
257850|NCT00175032|"~     The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal~     complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between~     lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in~     participants with osteoarthritis taking low dose aspirin.~   "
257851|NCT00175019|"~     The purpose of this study is to determine the long-term safety of febuxostat, once daily~     (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.~   "
257852|NCT00175006|"~     The purpose of this study is to determine the inter- and intra-rater reproducibility of~     direct physical measurement of tophus nodules in subjects with gout.~   "
257853|NCT00174993|"~     The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay~     the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg~     bypass surgery or amputation in patients with type 2 diabetes.~   "
257854|NCT00174980|"~     Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that~     die with severe head injuries. Laboratory studies in animals and clinical trials have shown~     that increasing oxygen in the brain results in better brain oxygen consumption, less cell~     death, and better functional outcome. This study will test the hypothesis that Oxycyte is an~     effective way to increase brain oxygen levels in severe head injury.~   "
257855|NCT00174967|"~     The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in~     reducing serum urate levels in subjects with gout.~   "
257856|NCT00174954|"~     The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging~     (MRI) in the quantitative assessment of tophus volume.~   "
257857|NCT00174941|"~     The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD),~     in maintaining serum urate levels within clinically acceptable levels in subjects with gout.~   "
257858|NCT00174928|"~     The purpose of this study is to understand how quickly lansoprazole, once daily (QD),~     improves feeding in premature babies or babies less than 28 days of age.~   "
257859|NCT00174915|"~     The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD),~     in subjects with gout.~   "
257860|NCT00174902|"~     This randomized double-blinded controlled trial uses a factorial design to investigate~     whether application of beta-blockers (inderal 80 mg) or aspirin (100 mg) or a combination~     thereof has an effect on the activation of the hemostatic system, the platelets and the~     endothelium in response to acute mental stress. Specifically we test the hypothesis that~     inderal attenuates the activation of the hemostatic system as compared to placebo. The second~     hypothesis is that aspirin attenuates the activation of platelets as compared to placebo.~     Subjects will be randomly allocated to either of the four following study arms: placebo -~     inderal - aspirin - inderal plus aspirin. Subjects will receive the study medication for five~     days prior to the mental stress. The acute mental stress consists of a public speaking~     session of 10 min duration immediately followed by a mental arithmetic test of 5 min~     duration. Blood will be collected prior to the stress, immediately thereafter, at 45 min at~     at 1 hour and 45 min.~   "
257861|NCT00174889|"~     Pregnenolone is a neurosteroid and possesses intrinsic behavioral and brain effects in~     animals, affecting the GABA(A) and other receptors. Pregnenolone is serves as the precursor~     for dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS). There is evidence of~     efficacy of DHEA augmentation in schizophrenia, we therefore sought to examine the efficacy~     of augmentation of antipsychotic treatment of schizophrenia patients with pregnenolone. It is~     hypothesized that the combined effect of antipsychotic agents and pregnenolone would be~     beneficial in the treatment of negative,depressive, and cognitive symptoms.~   "
257882|NCT00174616|"~     Primary objective:~        -  Pathological complete response (ypT0N0) rate~      Secondary objectives:~        -  Histopathological R0 resection rate~        -  Pathological downstaging (ypT0-T2N0) rate~        -  One month surgical complication rate~        -  Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes~        -  Safety~        -  Local and distant recurrence rates~        -  Progression-free survival~        -  Overall survival~   "
257862|NCT00174876|"~     A sizeable minority of patients suffering from major depression do not have their full set of~     depressive symptoms relieved by a single medication. Often times, a second medication is~     added to a patient's first antidepressant to obtain a better response in hopes of getting the~     depressed patient into full remission from symptoms.~      A typical psychiatric approach of recent has been to add one of the newer anti-schizophrenia~     medications to an existing FDA approved antidepressant in order to achieve better serotonin~     levels in the depressed patient's brain. This optimization of brain serotonin helps to~     alleviate more depressive symptoms. The newest antipsychotic medication to be FDA approved is~     Aripiprazole (Abilify). It may be particularly effective as it may safely elevate sertotonin~     through receptor 1a stimulation, receptor 2a blockade. It may also facilitate low levels of~     dopamine transmission which is truly novel for this agent when compared to other~     schizophrenia drugs. Depressed patients also tend to lack dopamine in their brains. This~     makes Aripiprazole and ideal agent to boost both serotonin and dopamine simultaneously. In~     theory, this may be an effective way to alleviate more depressive symptoms.~      The author suggests to enroll 10 subjects initially in open label fashion to take~     Aripiprazole plus their current FDA approved antidepressant to see if further elimination of~     depressive symptoms occurs and to show this pharmacological approach as a tolerable~     combination of medications. If there are no major safety issues, an amendment to allow 10~     additional subjects will be forwarded to provide a better tolerability sample size.~   "
257863|NCT00174863|"~     To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen~     prostate cancer patient without distant metastases with Time to Clinical progression as main~     objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms~     deterioration Quality of Life, PK analysis as secondary objectives~   "
257864|NCT00174850|"~     Anxious patients are now treated with Selective Serotonin Reuptake Inhibitor medications~     (common antidepressants) which elevate serotonin and thus alleviate anxiety. These~     medications have clearly proven efficacy upwards of 70% for many anxiety disorders. In~     regards to tolerability, they have a major problem in that they often produce sexual~     dysfunction in men and women (ie. decreased libido, anorgasmia, impotence) upwards of 30% of~     the time.~      Benzodiazepine anxiolytics are also FDA approved to treat anxiety with equal efficacy and~     greater tolerability (very little, if any sexual dysfunction). They do, however, carry a~     substantial risk for addiction. Tiagabine is a Selective GABA Reuptake Inhibitor (SGRI) that~     is FDA approved to treat certain types of epilepsy. Like benzodiazepines, Tiagabine also~     increases the neurotransmitter, GABA, in the brain and is thought to alleviate anxiety (see~     references below) this way too, but without any addiction risk common to Valium-type drugs.~     The safety profile of Tiagabine is thought to be much safer. Two double blind studies are~     ongoing which are looking at Tiagabine's effectiveness in PTSD and GAD. There are many open~     label studies showing anxiety reduction and many psychiatrists in clinical practice are~     utilizing this agent as an anxiety treatment in an off-label manner.~      This study is designed to evaluate anxious patients who are taking SSRI medication, have had~     a reasonable response, but are experiencing significant sexual side effects which are pushing~     them towards noncompliance and possible relapse into anxiety. 30 subjects (15 men and 15~     women) will be asked to join the study and be placed on Tiagabine as well as their current~     SSRI. Once an acceptable dose of Tiagabine is reached in the first four weeks, the subjects'~     SSRIs will be slowly stopped. Two weeks after enrollment, all subjects will be called in~     order to check for any side effects to the study drug and to insure that each subject is~     titrating to the proper dose of study drug according to the study protocol. An open-label,~     non-placebo prospective 10 week follow up will occur, where the now Tiagabine monotherapy~     subjects will be followed to see primarily if their sexual dysfunction improves and if there~     anxiety remains controlled.~   "
257865|NCT00174837|"~     The trial will compare the efficacy and safety of concomitant chemoradiation with~     tirapazamine, cisplatin and radiation versus cisplatin and radiation.~   "
257866|NCT00174824|"~     To compare the progression of diabetic retinopathy in type 2 diabetic patients with~     mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.~   "
257867|NCT00174811|"~     The clinical activity of telithromycin vs. cefuroxime in children with acute infections of~     the middle ear, ages 6 months to 59 months old will be studied.~   "
257868|NCT00174798|"~     To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric~     parameters in patients with OAB and UUI.~   "
257869|NCT00174785|"~     To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death~     from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter~     (AF/AFL).~      To assess that dronedarone is well tolerated in this population.~   "
257870|NCT00174772|"~     Primary Objective:~        -  To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy~          followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by~          consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC~          (stage IIIA- multiple cN2 or IIIB).~      Secondary Objective:~        -  To estimate efficacy parameters in overall response rate, progression free survival and~          1 year survival for each of the two above mentioned arms.~   "
257871|NCT00174759|"~     Primary objective:~      To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100~     mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in~     patients receiving a below knee bypass graft for the treatment of PAD.~      Secondary objectives:~      Comparison, between the two treatment groups, of :~        -  Primary patency,~        -  Assisted primary patency,~        -  Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.~        -  Ankle Brachial Pressure Index (ABPI) changes from baseline~   "
257872|NCT00174746|"~     To investigate the efficacy and safety of ciclesonide inhaled into the lungs in a range of~     doses in a new dry powder inhaler compared to ciclesonide inhaled into the lungs using a~     metered dose inhaler~   "
257873|NCT00174733|"~     To investigate the efficacy of ciclesonide MDI either as once daily or a twice daily regimen~     in patients with mild to moderate asthma, who have previously been treated with an inhaled~     corticosteroid.~   "
257874|NCT00174720|"~     To investigate the efficacy of ciclesonide MDI either as once daily or twice daily in~     patients with mild to moderate asthma, who have not previously been treated with an inhaled~     corticosteroid.~   "
257883|NCT00174603|"~     The purpose of this study is to examine the mood stabilizing and antipsychotic properties of~     quetiapine in the treatment of depression by comparing subjects who were randomly assigned to~     either quetiapine monotherapy, quetiapine and citalopram; or haloperidol and citalopram. We~     hypothesize that quetiapine monotherapy would have similar effects to the combination of a~     first generation antipsychotic plus an antidepressant for the treatment of a major depressive~     episode with psychosis.~   "
257885|NCT00174577|"~     The purpose of this study is to assess the safety and efficacy of risperidone augmentation in~     patients who have failed to respond or only partially responded to an adequate trial of an~     antidepressant.~   "
257875|NCT00174707|"~     Primary objectives:~        -  To compare the disease free survival (DFS) in patients treated with the sequential~          epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that~          in patients treated with the same treatment plus docetaxel given sequentially after~          epidoxorubicin~      Secondary objectives:~        -  To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and~          CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated with~          sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen~        -  To evaluate the overall survival in each arm~        -  To evaluate the tolerability of a sequential intensified~          epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)~        -  To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen~          versus a standard sequential epidoxorubicin/CMF regimen (arm A)~   "
257876|NCT00174694|"~     Primary objective:~        -  To demonstrate that the clinical efficacy of telithromycin (800 mg od for 5 days) is~          non-inferior to amoxicillin-clavulanic acid (875/125 mg bid for 10 days) at the~          test-of-cure (TOC) visit (Day 17-21) in subjects with acute bacterial sinusitis (ABS).~      Secondary objective(s):~        -  To assess the time to resolution of signs and symptoms between the baseline (Day 1) and~          TOC (Day 17-21) visits,~        -  To assess the rate of clinical relapse at the follow-up visit (Day 41-49),~        -  To assess health economic outcome until follow-up visit (Day 41-49),~        -  To assess quality of life up to the follow-up visit (Day 41-49),~        -  To compare the safety of telithromycin and amoxicillin-clavulanic acid,~        -  To compare the bacteriologic outcome of both treatments as observed at TOC (Day 17-21)~          and at follow-up visit (Day 41-49),in subjects with ABS.~   "
257877|NCT00174681|"~     Primary objective:~      The primary objective of this trial is:~        -  To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics~          drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and~          dietary measures in type 2 diabetics whose blood glucose control is acceptable but not~          optimal on maximum oral treatment, based on the number of patients achieving a HbA1c~          value < 7% at the end of treatment.~      Secondary objectives:~      The secondary objectives of this trial are to compare between the two treatment groups:~        -  The variation in HbA1c between baseline and end of trial.~        -  The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe~          hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia.~        -  Mean blood glucose levels at different times of the day.~        -  The variation in weight and lipid in each group between baseline and end of trial.~        -  The incidence of adverse events.~   "
257878|NCT00174668|"~     Primary objective:~      The primary study objective is to demonstrate superior efficacy of an intensified insulin~     regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin~     regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.~      Secondary objectives:~      Secondary study objectives are to compare the intensified insulin regimen with insulin~     glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of~     blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting~     plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic~     events, adverse events, change of late diabetes complications, weight, body-mass-index,~     course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria,~     standard lab and quality of life/treatment satisfaction.~   "
257879|NCT00174655|"~     Primary objectives:~        -  To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given~          either sequentially or in combination with doxorubicin and followed by CMF to~          doxorubicin alone or in combination with cyclophosphamide and followed by CMF in~          operable breast cancer patients with positive axillary lymph nodes.~      Secondary objectives:~        -  To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed~          by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive~          axillary lymph nodes~        -  To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin~          followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in~          operable breast cancer patients with positive axillary lymph nodes~        -  To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed~          by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast~          cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus~          polychemotherapy).~        -  To compare overall survival of treatment arms.~        -  To compare toxicity of treatment arms.~        -  To evaluate pathologic and molecular markers for predicting efficacy.~        -  Socioeconomic data will be collected in order to be able to perform a socioeconomic~          analysis by country, when needed.~   "
257880|NCT00174642|"~     Primary objectives :~        -  To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus~          metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm~          2) compared with insulin glargine plus metformin combined with 3 bolus of insulin~          glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal~          insulin therapy with oral antidiabetic drugs.~        -  To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus~          metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm~          2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea~          or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively~          (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy~          with oral antidiabetic drugs.~      Secondary objectives :~        -  To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of~          subjects with HbA1c <= 7% at the end of the study, evolution of blood glucose profiles,~          incidence of hypoglycemia, insulin doses, evolution of body weight and treatment~          satisfaction.~   "
257881|NCT00174629|"~     Primary Objective:~        -  To compare response rate between genotypic groups and control group.~      Secondary Objective:~        -  To determine the safety, time to treatment failure and survival in control and genotypic~          arms.~   "
257884|NCT00174590|"~     The purpose of this study is to determine the safety and efficacy of risperidone monotherapy~     in the treatment of psychotic depression. We hypothesize that risperidone is as equally as~     effective as haloperidol plus sertraline for depression with psychotic features~   "
271137|NCT00037414|"~     To evaluate the relationship bone marrow density and coronary artery and aortic~     calcification.~   "
257886|NCT00174564|"~     The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy~     in patients with advanced biliary tract cancer based on response rate measured by the RECIST~     unidimensional criteria.~      Secondary objectives are : Progression free survival, overall survival and safety.~   "
257887|NCT00174551|"~     Investigating the effect of prazosin for nighttime symptoms of civilian Posttraumatic Stress~     Disorder.~   "
257888|NCT00174538|"~     The objective of this study is to determine if a subject's genetic make-up would affect the~     treatment response to codeine in subjects with sickle cell disease.~   "
257889|NCT00174525|"~     This research study will assess whether AAB-001 is safe, well tolerated and effective for use~     in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside~     this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells~     to destroy other substances in the body). In Alzheimer's disease a protein called amyloid~     gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is~     hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to~     remove it.~   "
257890|NCT00174512|"~     To assess the effects of GTN on QT and QTc in subjects with And without atrial pacing. This~     will be done with and without autonomic blockade at two different pacing rates. Moxifloxacin~     effect on QT and QTc will also be assessed in atrially paced patients at two different pacing~     rates with and without autonomic blockade~   "
257891|NCT00174499|"~     The purpose of this research study is to evaluate the effects on existing tooth stain of~     nicotine gum. The study will enroll adults who have visible tooth staining.~   "
257892|NCT00174486|"~     Assessment of duration of action, safety & toleration of different formulations and doses of~     UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have~     previously been on PDE5 inhibitors and have been respondents to the drug. Duration of~     treatment is 4 weeks.~   "
257893|NCT00174473|"~     This is a study to investigate the pharmacokinetics, safety and tolerability of several doses~     of voriconazole, intravenous and oral suspension formulations, in children~   "
257894|NCT00174460|"~     Safety and efficacy of Somatropin will be evaluated in short children born with a list weight~     below 1500 g and that did not catch up to normal height at the age of 4.~   "
257895|NCT00174447|"~     Open label extension study of Ziprasidone, evaluation of safety of long term use of~     ziprasidone~   "
257896|NCT00174434|"~     This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients~     with metastatic or locally recurrent breast cancer who have not received chemotherapy~     treatment in the advanced disease setting.~   "
257897|NCT00174421|"~     This trial evaluates whether long-term treatment with Genotropin normalizes final (adult)~     height in short children born small for gestational age~   "
257898|NCT00174408|"~     The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in~     short children born SGA. Safety of the drug is a main objective as well. The growth promoting~     effect of two different dosages is compared. The effect of long-term treatment on final~     height is evaluated (according to several amendments)~   "
257899|NCT00174395|"~     To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the~     migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of~     migraine.~   "
257900|NCT00174382|"~     To document effectiveness, safety, and tolerability of donepezil in patients with mixed~     AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in~     patients with VaD. The effects of donepezil on executive functioning, behavior, general~     cognition, ADLs and global functioning will be assessed.~   "
257901|NCT00174369|"~     MEK is a critical member of the MAPK pathway involved in growth and survival of cancer cells.~     PD-325901 is a new drug designed to block this pathway and kill cancer cells. The purpose of~     this study is to study the effectiveness of PD-325901 in patients with non-small cell lung~     cancer. PD-325901 will be given by mouth as a pill twice a day, CT scans will be done and~     biopsies of a tumor and a blood sample will be taken before treatment to examine the how~     genes affect tumor response to the study medication. Blood samples will be taken to measure~     the amount of drug in the blood.~   "
257902|NCT00174356|"~     The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033~     in combination with paclitaxel and carboplatin in patients with NSCLC.~   "
257903|NCT00174343|"~     To evaluate clinical and pathologic response rates following primary hormonal therapy by~     exemestane (Aromasin®)~   "
257904|NCT00174330|"~     To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .~   "
257905|NCT00174317|"~     To determine if celecoxib 200 mg once daily is as effective as diclofenac 50 mg three times~     daily in the treatment of pain symptoms associated with osteoarthritis of the hip~   "
257906|NCT00174304|"~     To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage~     of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their~     governing guidelines.~   "
257907|NCT00174291|"~     -  To evaluate the effect of increasing the growth hormone dose on the statural response~        -  To assess the value of early treatment during the course of arthritic disease by~          comparing the height acquired in the medium term by children in the two groups: treated~          from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4~          years after the diagnosis~   "
257908|NCT00174278|"~     To assess the effect of long-term treatment by Genotonorm on linear growth~   "
257909|NCT00174265|"~     This is an extension study of A7501013 (P05771/NCT00145496) to further test~      the efficacy and safety of Asenapine compared with a~      marketed agent (olanzapine) in the treatment of patients with~      persistent negative symptoms of schizophrenia.~   "
257910|NCT00174252|"~     To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a~     child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12~     months after initiation of GH treatment.~   "
257911|NCT00174239|"~     The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in~     treating nighttime problems of Parkinson Disease.~   "
257912|NCT00174226|"~     Determine if there is a difference in treatment response for adults with ADHD who are treated~     with Strattera versus those treated with a combination of Strattera and buspirone~   "
257914|NCT00174200|"~     To assess the effect of risperidone 2 mg daily (QD) on the differential sensitivity of 2~     spatial working memory tests (the GMLT and MDR) in non-agitated, drug-naive patients~     suffering from first-episode schizophrenia/schizophreniform disorder.~   "
257915|NCT00174187|"~     -  To assess the effect of a long-term treatment by Genotonorm on linear growth in children~          with short stature receiving steroid therapy~        -  To assess the effect of a long term treatment with Genotonorm on bone mineralisation~        -  To assess the effect of a long term treatment with Genotonorm on body composition~   "
257916|NCT00174174|"~     The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness~     associated with narcolepsy. Both of the subjective and objective sleepiness of the patients~     were assessed in the experiment by repeat measures.~   "
257917|NCT00174161|"~     The purpose of these series research project is to investigate the prevalence, symptoms~     cluster and characteristic; establish the systemic symptom management nursing strategies~     (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health~     related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP~     offers a research and clinical based protocol to demonstrate the independent nursing role and~     practice care model. The 3-year series research process will include three research domains.~   "
257918|NCT00174148|"~     Systematically assessing the proprioception-coordination capacity of the spine in patients~     with different severity of neck disability could reveal how the dysfunction of the~     sensory-motor system was progressed. From the result of the research, a prospective study~     would be designed to test the hypotheses that described the mechanism of neck pain based on~     the results to the present study.~   "
257919|NCT00174135|"~     Health promotion in the elderly has been a major recent public health concern. Sarcopenia is~     a term utilized to define the loss of muscle mass and strength that occurs with aging. It has~     been demonstrated to be associated with decreased functional capacity among the elderly. The~     magnitude of the public health problem posed by sarcopenia is not yet established. The~     purposes of this study are to investigate sarcopenia and its relationship with functional~     status in elderly Taiwanese community-dwellers, and to develop the preventive strategy for~     sarcopenia in the elderly. Firstly, the investigators will recruit 100 volunteers (aged 18-90~     years old) to participate in this study. All of the participants will receive bioelectric~     impedance analysis (BIA), muscle strength and endurance assessment, physical activity level~     assessment by a seven-day recall questionnaire, protein intake assessment, cognition~     evaluation (Mini-Mental State Examination) and functional status assessment by the Functional~     Independence Measurement (FIM) questionnaire. A multiple regression model will be used for~     statistical analyses. Then, this project will be used to evaluate the efficacy of a 12-week~     supervised resistance strengthening exercise program for sarcopenia in the elderly.~     Participants who are defined as having sarcopenia from the previous examination will be~     randomized into either the exercise or control groups. Subjects in the exercise group will~     receive resistance strengthening exercises 3 times per week for 12 weeks. All measurements~     will be performed as described above. The investigators expect that resistance exercises are~     effective in offsetting age-related decline of muscle mass and strength in the elderly.~   "
257920|NCT00174122|"~     Nowadays, a physician plays a more important role in managing patients with potential~     infectious complications in the emergency room. Previous studies demonstrated the importance~     of early and adequate anti-microbial therapy in reducing the mortality and morbidity of~     patients with severe sepsis. However, in one study, about 6% of clinically significant~     bacteremic patients were misdiagnosed and discharged from the emergency room. In other~     studies, about 8.5 to approximately 17% of empirical antibiotic selection was judged~     inappropriately according to subsequent microbiology, and anti-microbial susceptibility was a~     result. It reflects the diversity in the presentations of infectious diseases and limited~     available microbiological reports from the first-line emergency physicians. Timely diagnosis~     and selection of appropriate antibiotics/treatment in treating those patients challenge an~     emergency physician more than ever before.~      A serum marker, procalcitonin, was recently demonstrated to be a potential indicator in~     distinguishing between non-infectious and infectious acute inflammatory reactions, viral and~     bacterial infections, and non-bacteremic and bacteremic infections. It also demonstrates the~     association with high-mortality risk in patients with severe sepsis. However, some areas~     remain inconclusive in the clinical application of this potential serum marker.~      The investigators designed this prospective study with the following purposes:~        1. To clarify the sensitivity and specificity of the serum procalcitonin quantitative test~          as a clinical indicator of sepsis;~        2. To identify the cut-off value of the serum procalcitonin level in sepsis screening among~          various groups of patients with different co-morbidities;~        3. To test the potential role of the procalcitonin quantitative test in identifying occult~          sepsis in patients with an acute undifferentiated febrile reaction in the emergency~          room;~        4. To test the possibility of the sequential procalcitonin quantitative test as a~          serological guide of the appropriateness of an empirical antibiotic before the~          microbiology results are available.~      Conclusions in the investigators' study will clarify the clinical application of the serum~     procalcitonin quantitative test in the differential diagnosis of patients with systemic~     inflammatory reaction syndrome, the screening of high-risk sepsis patients, and the~     effectiveness of an empirical antibiotic evaluation.~   "
257921|NCT00174109|"~     Clarify the relation of microtubule-associated protein 2 and cell migration~   "
257922|NCT00174096|"~     The purpose of this study is to investigate the relationship between SDF-1/CXCR4 and~     metastasis of laryngeal and hypopharyngeal squamous cell carcinomas.~   "
257923|NCT00174083|"~     Recent studies revealed that the ex vivo enzyme-linked immunospot (ELISPOT) assay for gamma~     interferon is a specific method for contact tracing of Mycobacterium tuberculosis infection.~     However, its use in endemic area and bacillus Calmette-Guérin (BCG)-vaccinated hosts has not~     been proved. We hypothesize that the TB-ELISPOT assay can be a rapid and accurate diagnostic~     tool for active tuberculosis in clinical suspects in Taiwan.~   "
257924|NCT00174070|"~     Acute respiratory failure (ARF) remains a common reason for admission to the intensive care~     unit (ICU). ARF to be present in 32% of patients on ICU admission, with a further 24% of~     patients developing ARF during the ICU stay. A total of 56% of all ICU admissions for a~     length of >48 h had ARF at some point during their stay. The incidence of ARF was from 88.6~     to 137.1 hospitalizations per 100,000 residents. The incidence of ARF was found to increase~     nearly exponentially with each decade until age 85 years. However, there is still paucity~     data about etiology and outcomes of acute respiratory failure happened in community.~      Mortality of ARF in critically ill patients is between 40% and 65%. Independent hazards for~     ARF mortality include older age, severe chronic co-morbidities (HIV, active malignancy,~     cirrhosis), certain precipitating events (trauma, drug overdose, bone marrow transplant), and~     multiple organ system failure (MOSF) [7-9]. Mortality has also been associated with acute~     lung injury or bilateral infiltrates on chest radiograph, and with an elevated acute~     physiology score.~      ARF patients form a large percentage of all ICU admissions and many factors might influence~     the final outcomes. With the high incidence of ARF in ICU, any improvement in the outcome of~     such population is likely to have marked effect on intensive care resource allocation. We~     wish this study may provide some valuable information about acute respiratory failure in~     community and improve the outcome of these patients.~   "
257925|NCT00174057|"~     The exact mechanism of the pathogenesis of Graves’ ophthalmopathy is still unknown.~     Histopathologically, extraocular muscle inflammation and orbital fat inflammation are two~     prominent changes. In the past year, we had investigated the morphological features of the~     Müller muscle in patients with thyroid lid retraction using the special stain and~     immunohistochemistry. In our findings, the smooth muscle cells, in the diseased group, were~     replaced by variable adipose and fibrosis tissues.~      In recent years, TSHR, has been verified to express in orbital connective tissue and~     extra-ocular muscle. From functional studies and an increase in adipogenesis in cultured~     fibroblasts with expression of TSHR protein, the role not only the target but effector cells~     in orbital fibroblasts were validated. Quantitative RT-PCR may help to differentiate whether~     a less extent of expression at the end stage or low protein amount to be detected.~      In recent years, the diverse phenotypes of orbital fibroblasts, with regard to expression of~     Thy-1 protein or not, had been reported from several studies, the investigators believed~     heterogeneity in orbital fibroblast may determine the clinical presentation of~     Graves’ophthalmopathy. We also are curious to know if the phenotypic heterogeneity of the~     fibroblasts in the ocular adnexal and orbital tissues correlates to distinct morphological~     features of adipogenesis and fibrosis.~      Moreover, increased CD40 expression in skin fibroblasts were noted from patients with~     systemic sclerosis. Expression of IGF-I and IGF-IR seemed to be up-regulated in processes of~     several fibrotic diseases. A nuclear transcription factor, PPAR-γ, has been verified to have~     a close relationship with adipogenesis. We hypothesize that some immunological processes~     involve the ocular adnexal and orbital tissues, which result in various ophthalmological~     manifestations.~      The purpose of this study is to investigate the different stage of the ocular adnexal and~     orbital tissues to identify the pathogenesis of Graves' ophthalmopathy by frozen sections~     with Immunohistochemistry, mRNA expression of TSH receptor, PPAR-γ, IGF-1R, and IGF-1 and~     different cytokines using quantitative RT-PCR and flow cytometry at the acute and stable~     stage in GO.~   "
257926|NCT00174044|"~     Tripping over obstacles is one of the common movements in daily life and is the most~     frequently mentioned cause of falls in the elderly. Indeed, crossing obstacles is a more~     complex motor skill than walking, and ensuring sufficient clearance of an obstacle during~     locomotion requires accurate movement and appropriate modifications of the swing limb.~     However, little is known about the obstacle crossing deficits that following stroke,~     especially in good outcome and function independently strokes. It is still a mystery about~     motor control and motor plastic of central nerve system.~      The purpose of the study was to observe and quantify certain characteristics of the~     performance of subjects following stroke with good outcome to understand the damage of~     central nerve system how to affect motor control. The present study investigated selected~     spatial-temporal characteristics, kinematic variables and kinetic variables of the gait~     pattern to define further the problems in obstacle crossing following strokes. To quantify~     the deficits, we compared results from a group of subjects with stroke with a group of~     healthy subjects matched for age, gender, and height.~   "
257927|NCT00174031|"~     To investigate prevalence and profile of sports injury in Taiwanese adolescent baseball~     players in a longitudinal study.~   "
257928|NCT00174018|"~     To investigate validity and reliability in measuring the subacrominal space by using~     ultrasound~   "
257929|NCT00174005|"~     The purpose of this study is to estimate the validity and reliability in the measurement of~     bicep and tricep tendons and muscular morphologic characteristics by using ultrasound.~   "
257930|NCT00173992|"~     The specific aims of this research are delineated as the following:~      Aim 1: To investigate the neuromuscular and biomechanical mechanisms of the emerging~     processes of proactive and reactive balance control during sitting and standing in patients~     with stroke at different stages of the recovery course.~      Aim 2: To determine the relationships between brain lesion sites and the recovery patterns of~     reactive and proactive balance control mechanisms in patients with stroke.~      Aim 3: To determine the relationships between the impairments in reactive and proactive~     balance control mechanisms and functional outcome as well as fall incidence in patients~     following stroke.~      Aim 4: To investigate the efficacy of different training regimens in improving reactive and~     proactive balance control strategies and in preventing falls in stroke patients with~     different brain lesion sites.~      Principally, three hypotheses are to be tested:~      Hypothesis 1:The emerging processes and recovery patternes of proactive and reactive balance~     control may be different among stroke patients with different brain lesion locations.~      Hypothesis 2:There are positive correlations between the level of impairments in reactive and~     proactive balance control mechanisms and functional outcome as well as fall incidence in~     patients following stroke.~      Hypothesis 3:Training regimens that could best facilitate the emergence or improvement in~     reactive and proactive balance control strategies are different.~   "
257931|NCT00173979|"~     This current study tests whether the load-displacement and stress-strain characteristics of~     human bicep and tricep muscles and tendons change during graded maximal voluntary elbow~     extension and flexion exercises.~   "
257932|NCT00173966|"~     Endothelial function is closely related to the hemostasis , vascular tone, and organ~     perfusion in cardiovascular system, and its dysfunction would cause overactivation of the~     coagulative system to induce thrombus formation. So we study the relationship between the~     endothelial function and atrial fibrillation.~   "
257933|NCT00173953|"~     The aims of this study are 1) to determine the cytokines produced by both Th1 and Th2 subsets~     in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori~     therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of~     mucosal lymphocytes in H. pylori-associated gastritis and to define possible contributing~     immune mechanisms responsible for the chronicity of the disease and its associated lesions.~   "
257934|NCT00173940|"~     In summary, the researchers want to construct a longitudinal data bank using voluntary health~     examination participants. Researchers in the National Taiwan University Hospital (NTUH)~     campus can utilize these data to clarify the effects of several genetic and environmental~     factors on various common diseases in Taiwan in the future.~   "
257935|NCT00173927|"~     The goals of this trial are:~        1. To compare the sensitivity and specificity of various tools including Doppler and~          magnetic resonance imaging (MRI) for diagnosing vertebral artery stenosis and carotid~          artery stenosis. The positron emission tomography (PET)/MRI fusion imaging will be a~          promising tool to provide both anatomical and functional imaging for vulnerable plaques.~        2. To identify patients at high risk of plaque rupture by image studies, biomedical~          profile, and gene expression of circulating monocytes.~   "
257969|NCT00173485|"~     A progressive decline of plasma triggering receptor expressed on myeloid cells-1 (TREM-1)~     concentration indicates a favorable clinical evolution during the recovery phase of sepsis.~     The expression of TREM-1 in dialysate of peritoneal dialysis patients was not yet documented.~     We will collect the dialysate of peritonitis in peritoenal dialysis patients and analyze the~     time serial change.~   "
258124|NCT00171470|"~     Study to provide initial data to assess the safety and efficacy of tegaserod use in patients~     with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.~   "
257936|NCT00173914|"~     Progressive cardiac allograft vasculopathy (CAV) is a serious complication in long-term~     survivors after heart transplantation. Therefore, we hypothesize that CAV is a diffuse and~     progressive process, and endothelial function may play an important role in predicting~     clinical outcome after heart transplantation. Therefore, this single-blinded study is~     designed to evaluate endothelial function, microvascular flow response and morphology of~     coronary artery in cardiac allografts,~        1. The simultaneous use of IVUS and Doppler wire instrumentation in different~          pharmacological stress;~        2. Tl-201 SPECT (dipyridamole stress/rest); to evaluate the correlation of endothelial~          function, coronary morphology change and Tl-201 dipyridamole stress myocardial perfusion~          image.~   "
257937|NCT00173901|"~     The purpose of this study is to understand whether generic ceftazidime causes different~     adverse drug reaction incidence from the brand drug.~   "
257938|NCT00173888|"~     The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential~     chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and~     gemcitabine plus cisplatin followed by weekly docetaxel。~   "
257939|NCT00173875|"~     The purpose of this study is to assess the overall response rate to Iressa as a first-line~     treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer (NSCLC)~   "
257940|NCT00173862|"~     The purpose of this study is to evaluate the efficacy of Gemcitabine plus Ifosfamind as~     second line chemotherapy in advanced transitional cell carcinoma in terms of response rate~     and overall survival .~   "
257941|NCT00173849|"~     Investigate the role of SDF-1/CXCR4 in the metastasis of oral squamous cell carcinoma~   "
257942|NCT00173836|"~     Significant evidence has shown that radiation therapy for patients with nasopharyngeal cancer~     (NPC) can cause swallowing abnormality. Based on our prior cross-sectional study for 184 NPC~     patients from 1995 to 1999, the findings of videofluoroscopic swallowing study (VFSS)~     revealed continuous deterioration of swallowing function of these patients even many years~     after radiation. We conducted a prospective study to evaluate the longitudinal change of~     swallowing function based on VFSS before, one month, one year and two years after completing~     radiation therapy. The amount of saliva was measured at the same time of VFSS study to test~     the relationship of decreased amount of saliva and swallowing function. Comparison of serial~     VFSS studies in NPC patients (n=84) and normal volunteers (n=38) were obtained. We assume~     that this study may reveal a complete understanding of changing swallowing patterns in the~     course of radiation therapy of patients with NPC. From this study, NPC patients can~     understand their own swallowing function. Therefore, the information may enable for earlier~     intervention of swallowing training or correction to avoid morbidity of radiation therapy in~     this patient group.~   "
257943|NCT00173823|"~     According to the reports of the United States Renal Data System (USRDS), there is a 25%~     annual mortality rate with nearly 50% of all reported maintenance hemodialysis (HD) patient~     deaths attributed to atherosclerosis-related complications. Although traditional risk factors~     of cardiovascular disease (CVD) are common in end-stage renal disease (ESRD) patients, they~     alone may be insufficient to account for their high prevalence of CVD. Recent evidence~     demonstrated high plasma homocysteine levels have been established as a risk factor of~     chronic inflammation and atherosclerosis in patients with ESRD.~      Malnutrition and inflammation was associated with poor quality of life, morbidity and~     mortality. We, the researchers at National Taiwan University Hospital, hope to establish the~     best predictive profile of HD patient outcome. Thus, we establish several protocols to~     complete this work.~   "
257944|NCT00173810|"~     We will employ modern test theory (i.e., Rasch model) to refine the Stroke Rehabilitation~     Assessment of Movement instrument (STREAM), which will be called the refined version of the~     STREAM, R-STREAM).~   "
257945|NCT00173797|"~     This study is going to comprehensively examine the psychometric properties of the three~     depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale~     (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years.~   "
257946|NCT00173784|"~     This study is to develop an IADL Scale for patients with SCI (IADL-SCI) and examine its~     psychometric properties in three years.~   "
257947|NCT00173771|"~     our research team will develop a new CADL scale for stroke patients over the next three~     years.~      In the first year, we had established a CADL item bank of 50 items. The investigators will~     administer the 50 items on 300 patients with stroke living in the community. Then we will~     select 10 to 15 items from the item bank for the CADL scale based on the International~     Classification of Functioning, Disability and Health (ICF), the opinions of an expert panel,~     and Rasch analysis. It is anticipated that the CADL scale will have unidimensionality, an~     interval level of measurement, soundly psychometric characteristics, a reduced number of~     items, and ease of administration.~      In the second and third years, we will compare the psychometric properties of the CADL scale~     and the combined BI and FAI scale. The psychometric properties investigated will include~     reliability (e.g. inter-rater reliability, intra-rater reliability, and internal~     consistency), validity (e.g. concurrent validity, convergent validity, predictive validity~     and discriminant validity), and responsiveness. A total of 150 patients will be recruited.~     Both the CADL scale and the combined BI and FAI scale will be used on patients from the~     initial stage (within one month) to six months after hospital discharge. The results will be~     useful for researchers and clinicians to determine whether the CADL scale is better than the~     combined BI and FAI scale in stroke patients.~   "
257978|NCT00173368|"~     Using a needle knife papillotome by an experienced endoscopist, endoscopic sphincterotomies~     were performed in difficult cannulation cases. In a prospectively collected database, we~     investigate the complications of those with ampullary impacted stone.~   "
257979|NCT00173355|"~     Retrospective review of clinical outcome of pediatric Dermatofibrosarcoma Protuberans (PDFSP)~     after active invitation~   "
257980|NCT00173342|"~     This study is to determine 1) the incidence of altered right bundle conduction, including~     CRBBB, IRBBB or rsR’ pattern in the Taipei city based on the school survey databank from 1999~     to 2002, 2) the associated cardiac lesions, 3) clinical presentations relevant to the altered~     right bundle conduction, 4) the association with QTc prolongation and dispersion and HRV from~     a 5-minutes recording. Finally, molecular characterization for those with CRBBB or Brugada~     pattern EKG, especially those with positive family history will be studied.~   "
257948|NCT00173758|"~     Human decidual tissue appears to play an important role not only in nurturing the implanted~     embryos, but also in preventing its rejection by the maternal immune system. Insight into the~     maternal immunologic modulations during implantation is our main research interests. Our~     previous studies have shown that most lymphocytes in deciduae are natural killer cells.~     However, their phenotype is CD16-CD56+CD3-, which is different from that of peripheral~     natural killer cells. More importantly their cytotoxic activity is decreased and they can’t~     attack the cytotrophoblasts. All of these contributes to no rejection developing at the~     fetomaternal interface and are related to success of pregnancy.~      In 1994, a new cytokine IL-15 was first discovered, which could act on the IL-15 and IL-2~     receptors to stimulate the activation and propagation of the lymphocytes. Let us want to~     study the critical role of IL-15 in the endometrial lymphocytes. In this study, we try to~     analyze the distribution of IL-15 and its receptor in deciduae. We will clarify whether the~     IL-15 receptor exists on the decidual natural killer cells and it is regulated by sexual~     hormones or not and whether their cytotoxic activity will change after IL-15 action.~     Furthermore, we will demonstrated whether the IL-15 receptor exists on the embryo cells and~     IL-15 might improve the quality of the embryo. We also design a co-culture system of the~     embryo and autologous endometrial cells to improve the success rate of in vitro~     fertilization.~   "
257949|NCT00173745|"~     The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to~     treat drooling in children with cerebral palsy, and to find the most appropriate dosage,~     duration of effect and side effects.~   "
257950|NCT00173732|"~     Preimplantation genetic diagnosis (PGD) is the integration of both assisted reproductive~     technologies and molecular genetic technologies and was shown to improve implantation rate~     and reduce spontaneous abortions after implantation. The principal problems in single cell~     PCR include amplification failure, ADO and contamination. Multiple displacement amplification~     (MDA) is a technique used in the amplification of very low amounts of DNA and reported to~     yield large quantities of high-quality DNA. By this approach, the diagnosis of gene disorders~     form single cell will be more accurate and reliable.~   "
257951|NCT00173719|"~     The primary purposes of the this three-year research proposal are to investigate the~     influence of assistive device use on dynamic balance and the associated attentional demands~     during standing and walking in patients with stroke~   "
257952|NCT00173706|"~     This is a study designed to test the hypothesis that treatment with L-carnitine will improve~     the quality of life and some specific symptoms and signs in patients with renal failure~     submitted to hemodialysis.~   "
257953|NCT00173693|"~     This study aims to conduct a cost-effectiveness analysis (CEA) among the programs for~     preventing osteoporotic fracture. The main comparison will be made among the effects of three~     programs for preventing osteoporotic fractures: 1. health education; 2. exercise intervention~     for enhancing bone mineral density (BMD); 3. exercise intervention for preventing falls. The~     cost will be measured bases on the monetary cost of implementation of each program. The~     effectiveness will be measured includes the number of prevented osteoporotic fractures of~     each program, and related outcomes are the follows: 1. the medical cost of osteoporotic~     fracture; 2. the change of BMD in consecutive years; 3. the quality of life (QOL) of patients~     with osteoporotic fracture as compared to the reference population.~   "
257954|NCT00173680|"~     This project is to study the methylation status of the transcriptional regulatory region of~     CD44 gene in surgically resected NSCLC specimens and normal lung tissue, correlate the~     methylation status of promoter region with the expression of CD44 gene, and analyze if~     methylation is associated with survival.~   "
257955|NCT00173667|"~     Objective:~        -  To evaluate the antihypertensive efficacy of two brands of nifedipine 30mg in patients~          with hypertension.~        -  To assess the safety of 8 weeks of therapy with two brands of nifedipine 30mg in~          patients with hypertension.~        -  To study flow-mediated dilatation and oxidative stress in nonsmoker with essential~          hypertension but without diabetes mellitus or dyslipidemia.~      Study Design:~        -  Head-to-head, randomized and parallel design.~        -  A total of 60 patients with a clinically confirmed diagnosis of hypertension will~          provide 30 available patients in each treatment group.~        -  The drugs and dosage will be as follows:~      Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once~     daily (Adalat OROS, Bayer)~      Method:~      After washout period, the eligible patients will randomly be allocated to receive two brands~     of nifedipine 30 mg once daily. Each patient will receive two times of ambulatory blood~     pressure measurement (ABPM) at both entrance and final stages of the study. The patients will~     also undergo complete clinical evaluation. Therapy dosage will be started at a dose of~     nifedipine 30 mg once daily. Dosage will be adjusted if systolic blood pressure greater than~     140 mmHg or diastolic blood pressure greater than 90 mmHg by office measurement after 4 weeks~     of treatment. Nifedipine will be increased to 60 mg once daily. The Ambulatory blood pressure~     measurement will be set to take reading at 1-hour intervals during the 24 hours assessment.~      Physical examination included the measurement of heart rate and blood pressure. The value~     will be read on Visit 1 and 3-12 hours after the last dose of nifedipine. Routine laboratory~     test includes hematology, blood chemistry and urinalysis. Hematology test and fasting blood~     chemistry test will be measured immediately before the start of treatment and after 8 weeks’~     treatment or at time of discontinuation. Thiobarbituric acid–reactive substances (TBARS) in~     patient plasma were measured for oxidative stress and endothelium-dependent flow-mediated~     vasodilation will also be evaluated. Possible concomitant medication will remain constant~     throughout the study. The physician will question the patients as to their compliance at each~     visit. If compliance dose not reach 80%, the subject will be dropped out.~   "
257956|NCT00173654|"~     To disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.~   "
257957|NCT00173641|"~     Evaluate the regulatory T cell function in patients with type 1 diabetes mellitus, and find~     the pathogenesis of this autoimmune disease.~   "
257958|NCT00173628|"~     Evaluate the autoantibodies, such as glutamic acid decarboxylase (GAD65), tyrosine~     phosphatase (IA-2 or ICA125), islet autoantibodies (IAA) and other associated autoimmune~     autoantibodies: microsomal antibodies, thyroglobulin antibodies, gastric parietal cell~     antibodies in patients with type 1 DM.~   "
257959|NCT00173615|"~     Analysis of the patients' data who were rescued with extracorporeal membrane oxygenation and~     without ECMO. The survival rate and the weaning rate were analyzed to see the effect of ECMO~     on the prolonged CPR.~   "
257960|NCT00173602|"~     The investigators want to evaluate the burden of peripheral artery occlusion disease in~     Taiwan peritoneal dialysis (PD) patients by using ankle-brachial pressure index (ABI) and~     toe-brachial pressure index (TBI). Furthermore, the investigators hope to demonstrate the~     possible casual factors of peripheral artery occlusion disease (PAOD) in PD patients.~   "
257961|NCT00173589|"~     Inflammatory and Fibrotic protein markers in patients with atrial fibrillation~   "
257992|NCT00173186|"~     The major risk factors of aortic valve replacement in three outlet types VSD after surgical~     repair were the severity of preoperative AR and older operation age. For those patients with~     less than moderate degree AR preoperatively, AR progressed rarely and all in those with~     aortic valvar and subvalvar anomalies.~   "
257962|NCT00173576|"~     Severe acute Respiratory Syndrome (SARS) is an emerging infectious disease. It is caused by a~     novel SARS-associated coronavirus. According to the epidemiological data, it is highly~     infectious by intimate contact, respiratory secretion, or direct contact with infectious body~     fluid. By June 1, 2003, Center for Disease Control Taiwan, R.O.C reported 677 probable SARS~     cases. Among them, 93.2% (631/677) were more than 20 years old. Only 6.8% (46/677) were under~     20 years old. Usually the major hosts of respiratory viruses are children, but evidence up to~     now shows that SARS is mainly a disease of adults. The data of clinical presentation and~     epidemiological prevalence in teenage group and children are lacking. Therefore, this project~     is aimed at the children and teenager among 1 month to eighteen years old. Seroepidemiology~     of SARS-CoV infection in children would be investigated. Patients who admitted to pediatric~     wards or visited ER and received blood sampling due to the need of clinical~     diagnosis/management would be enrolled. After the necessary laboratory examinations were~     done, the remaining serum would be collected and tested for anti-SARS-CoV IgG by ELISA.~   "
257963|NCT00173563|"~     Severe acute respiratory syndrome (SARS) is a new emerging infectious disease. Its pathogen~     is a newly discovered coronavirus (SARS-CoV). The clinical course can be classified to 3~     stages: viral replication phase, hyperimmune reactive phase, and pulmonary destruction phase.~     Human monocyte plays a critical role in the initiation of immune response in defending the~     intracellular pathogens (eg viruses). Monocytes can engulf viruses and present the viral~     antigens in the major histocompatibility (MHC) molecule to the cell surface to initiate T~     lymphocyte response. Monocytes also secrete various cytokines to modulate immune response.~     SARS-CoV is a mutant of animal virus to cause human disease and is able to cause unusual~     severe respiratory illness. It is suggested the unusual severe disease is due to the intense~     immune reaction.~      The investigators will harvest human monocytes from healthy adult and children blood donors.~     Monocytes would be cultured and infected by SARS-CoV. The change of viral load is monitored~     after infection. Cytokines secreted by monocytes after infection are also measured. The~     difference of monocyte cytokine secretion is compared between adults and children. The study~     is to verify the SARS-CoV infectivity of human monocytes and prove the unusual severity~     caused by SARS-CoV is related to viral-induced dysregulation of cytokine responses. The~     results may also clarify why adults tend to have a more severe illness compared with~     children.~   "
257964|NCT00173550|"~     The aim of this study is to survey patient’s cognition and attitude about health-related~     quality of life, use of estrogen, experience of menopausal syndrome, compliance of~     medication, experience, and satisfaction for women who underwent hysterectomy and bilateral~     oophorectomy before menopause.~   "
257965|NCT00173537|"~     Primary pulmonary hypertension (PPH) is a rare lung disorder in which the blood pressure in~     the pulmonary artery rises far above normal levels for no apparent reason. The pulmonary~     artery is a blood vessel carrying oxygen-poor blood from the right ventricle (one of the~     heart's pumping chambers) to the lungs. In the lungs, the blood picks up oxygen, then flows~     to the heart's left side, where the left ventricle pumps it to the rest of the body through~     the aorta. In the United States, an estimated 500 to 1,000 new cases of primary pulmonary~     hypertension are diagnosed each year. The greatest number is reported in women between ages~     20 and 40. However, men and women in all age ranges as well as very young children can~     develop PPH. Researchers have identified more than 40 BMPR2 mutations that can cause primary~     pulmonary hypertension. Many of these mutations introduce a stop signal that halts protein~     production prematurely, decreasing the amount of functional BMPR2 protein. Other mutations~     prevent the BMPR2 protein from reaching the cell surface, or alter its structure so it cannot~     form a complex with other proteins. It remains unclear how BMPR2 mutations cause primary~     pulmonary hypertension. Researchers suggest that a mutation in this gene prevents cell death~     or promotes cell proliferation, resulting in an overgrowth of cells in the blood vessels of~     the lungs. Cell overgrowth can narrow the diameter of the vessels, restricting blood flow and~     resulting in elevated blood pressure. However, it has not yet been reported regarding the~     genetic variants in Taiwan. Further details have been described in this project proposal.~   "
257966|NCT00173524|"~     The objective of this pharmacoeconomics (PE) study is to evaluate the cost- effectiveness~     analysis and cost-utility analysis of IRESSA® as first line treatment of NSCLC from the~     society perspective, based on resources and outcomes from patients who met the inclusion~     criteria for this naturalistic study comparing to existing first line platinum-based regimen~     chemotherapy.~   "
257967|NCT00173511|"~     Background:~      Upper gastrointestinal (GI) bleeding, a common disorder encountered at emergency room, may~     cause hypotension and tachycardia that may in turn result in myocardial ischemia in patients~     with coronary artery disease (CAD). An emergent endoscopy with hemostasis is the mainstay of~     management. However, endoscopy itself may result in myocardial ischemia. Whether myocardial~     ischemia and arrhythmia occurs more frequently during emergent endoscopy in patients with CAD~     remains unknown.~      Objective:~      To determine whether the risk of myocardial ischemia and arrhythmia is increased during~     emergent endoscopy in patients with CAD.~      Method:~      Adult patients with documented CAD undergoing emergent endoscopy due to UGI bleeding are~     included. Adult patients without CAD undergoing emergent endoscopy due to UGI bleeding were~     included as the control group. The expected case numbers were 50 patients in each group.~     Patients with terminal illness, pregnancy, active lung disease requiring ventilator support~     are excluded. Before endoscopy, symptoms of myocardial ischemia, blood pressure, heart rate,~     O2 saturation, hemogram, baseline 12-lead EKG, and cardiac enzyme are obtained. All patients~     are monitored with Holter EKG since 10 minutes before endoscopy to 2 hours after the~     procedure. Blood pressure, heart rate, and O2 saturation are closely monitored during the~     procedure. Endoscopy is performed by experienced endoscopist and endoscopic hemostasis is~     done according to the types of lesions. The duration of endoscopy, types of endoscopic~     hemostasis, and blood pressure are recorded. After endoscopy, symptoms of myocardial~     ischemia, blood pressure, heart rate, O2 saturation, hemogram, baseline 12-lead EKG, and~     cardiac enzyme are checked again.~      Keywords: Emergent endoscopy, coronary artery disease, cardiovascular events~   "
257968|NCT00173498|"~     To analyze the common allergens revealed by skin tests in adult atopic dermatitis patients.~   "
258125|NCT00171457|"~     Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention~     of the stomach~   "
266283|NCT00077714|"~     The purpose of this trial is to determine if paliperidone ER is an effective treatment for~     adults with schizophrenia.~   "
257970|NCT00173472|"~     The present project will follow our previous phaseⅡ study of FOLFOX regimens for the~     treatment of stage Ⅳ colorectal cancer. We will recruit at least 200 patients for this study.~     The selection of patients will be based on rigorous eligibility criteria. The patients will~     be allocated based on the expression of each molecular marker (MSI, TS, DPD, MVD and EGFR)~     and the implementation of chemotherapy. For example, in the examination for the clinical~     implications of EGFR, the patients will be classified into four groups: EGFR（＋）~     chemotherapy（＋）; EGFR（＋） chemotherapy（－）; EGFR（－） chemotherapy（＋）; EGFR（－） chemotherapy（－）.~     Base on the analysis of this 2×2 table, we will clarify the prognostic significance of a~     specific molecular marker is due to whether the specific molecular marker predicts biological~     invasiveness and/or chemosensitivity. We believe the present study will have the following~     significance: （1）To further clarify the mechanisms for the carcinogenesis and progression of~     CRC; （2）To facilitate the development of novel chemotherapeutic agents; and （3） To gain the~     experience for the practice of evidence-based medicine.~   "
257971|NCT00173459|"~     Severe acute respiratory syndrome (SARS) is an emerging infectious disease caused by a novel~     coronavirus (SARS-CoV). The major clinical features of SARS include fever, dyspnea,~     lymphopenia, and a rapid progression of pulmonary infiltrates on chest radiologic images. The~     SARS-related deaths have resulted mainly from pulmonary complications, including progressive~     respiratory failure due to alveolar damage and acute respiratory distress syndrome (ARDS).~     Pathological changes in SARS suggest that SARS sequelae such as infiltration of PMN in lung~     tissue, multiple organ dysfunction and ARDS have been associated with cytokines and chemokine~     dysregulation. Some patients still manifested lung injury at a time when the viral load was~     falling also supports the immune nature of the lung damage. We therefore undertook an~     analysis of dynamic production of cytokine/chemokines in SARS patients with an initial normal~     chest radiograph in order to improve understanding of disease pathogenesis and improve~     patient management.~   "
257972|NCT00173446|"~     Dopamine (DA) is one of the main catecholamines in mammals. Its major role as a brain~     neurotransmitter is well known as well as its contribution to the development of pathologies,~     mainly arterial hypertension. Traditionally, dopamine receptors are divided into two families~     according to the stimulation or inhibition they may produce at the adenyl cyclase level. Five~     dopamine receptors have been identified: D1 (D1a) and D5 (D1b) exist in the D1 family. D2s,~     D2l, D3 and D4 belong to the D2 family. Formerly, less than 1% of patients with hypertension~     were believed to have primary hyperaldosteronism; however, recent studies have suggested that~     primary aldosteronism affects 5-13% of patients with hypertension and aldosteronomas are a~     more common cause of hypertension than previously thought. At least 2% of patients with~     hypertension may have an aldosteronoma. The investigators' previous clinical observation~     found two subtypes of aldosterone-producing adenoma (APA), which were defined according to~     their responses to metoclopramide during salt manipulation. On a high-salt diet (HS), the~     nonsuppressible subjects, with less dopaminergic inhibition of aldosterone secretion, had~     less urinary DA excretion and greater blood pressure (BP) elevation [Wu KD et al. 2002]. The~     investigators' recent study of six patients with an APA found that the expression of the D2~     receptor in APA was not universal. The amounts of D2 receptor messenger ribonucleic acid~     (mRNA) were more variant in either APA or their remnant adrenal glands. Only two cases of APA~     expressed the D2 receptors with much weaker signals compared with those in their respective~     remnant adrenals [Wu KD et al. 2001]. The investigators' current work demonstrates that the~     D2 receptor negatively regulates AII-stimulated aldosterone secretion and aldosterone~     synthase mRNA expression in NCI-H295R cells. On the other hand, the D4 receptor counteracts~     with the effect of the D2 receptor. In a future study, the investigators wish to quantify D2~     and D4 receptor mRNA and protein expression in APA and their remnant adrenal glands and~     correlate them to their clinical metoclopramide test results. The investigators also wish to~     know whether the difference between the D2 and D4 receptor expression reflect the different~     effects of dopamine inhibition on AII-stimulated aldosterone secretion and aldosterone~     synthase transcription. Finally, the investigators will explore the role of D2 and D4~     receptors on AII-stimulated adrenal cell proliferation.~   "
257973|NCT00173433|"~     we hypothesize that exogenous reinfection is very important in the Taiwan endemic. Therefore,~     we design a series of studies to evaluate the individual contribution of exogenous~     reinfection and endogenous reactivation in the Taiwan endemic, and to realize the impact of~     exogenous reinfection. First, we will identify the patients with TB relapse after complete~     treatment. The M. tuberculosis isolates responsible for their initial and recurrent episodes~     will then be genotyped to clarify the percentage of exogenous reinfection and endogenous~     reinfection.~   "
257974|NCT00173420|"~     In order to clarify the normal components of thermal and painful evoked potentials by heat in~     normal subjects of both genders and different age group, to clarify the effect of specific~     anatomy in pain transduction, transmission and modification, and to establish the effect of~     peripheral nerve and their terminal free ending on the nociceptive transduction, the~     investigators will use heat stimulation on normal controls and patients with neurological~     diseases to clarify such issues.~   "
257975|NCT00173407|"~     We have identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion~     suppressor gene in ovarian endometrioid carcinoma, and showed association with lower cancer~     migration, invasion and metastasis. Recently, a novel model of ovarian EC formation from~     endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation~     of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of~     the major epigenetic changes. This tumorigenesis model has lots of similarity to our~     established invasion model. Therefore, we plan to study the important of PTEN expression in~     ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by~     studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to~     study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in~     ovarian EC.~   "
257976|NCT00173394|"~     Ovarian cancer is the first in mortality rate of the gynecologic malignancies and the overall~     5-year survival rate of ovarian cancer is only 20–30%. Besides, the incidence of ovarian~     cancer increased in recent years in Taiwan. Ovarian cancer is indeed a disease that should be~     respected, however, there has only been a little research done focusing on it in Taiwan.~     Patients with ovarian cancer who have stage I disease (localized to ovaries) after optimal~     surgical staging do not need any adjuvant therapy. In contrast, patients with disease~     spreading beyond the ovaries have median survival rates that decrease to < 10% for patients~     with bulky residual disease after surgery and treated with platinum-based combination~     chemotherapy. In developing effective therapy for ovarian cancer, there should be a~     distinction between preventative and therapeutic approaches. Immunoprevention will be~     developed for women who are at an increased risk for the development of ovarian cancer. In~     contrast, immunotherapy would be used as an adjuvant to surgery or in combination with~     chemotherapy or other biologics as chemoimmunotherapy or biochemoimmunotherapy. Mesothelin is~     expressed in some normal epithelial cells and is elevated in certain carcinomas. Mesothelin~     has been reported to be selectively overexpressed in most of the non-mucinous ovarian~     carcinomas. In addition, the specific epitopes of mesothelin in the HLA-A2 and A24 haplotype~     have been identified. It seems that mesothelin has the potential to be a target antigen for~     the immunotherapy of ovarian cancer.~      So the investigators would like to provide this proposal to address the development of~     mesothelin -specific immunologic assays. There are two aims in this project:~        1. to develop and utilize assays to measure cytotoxic T lymphocytes (CTLs) to mesothelin,~          and~        2. to evaluate the mesothelin-specific immunologic responses between normal control and~          ovarian cancer patients.~   "
257977|NCT00173381|"~     The purpose of this study is to investigate the role of lymphangiogenesis in the metastasis~     of head and neck cancer.~   "
269997|NCT00002981|"~     RATIONALE: New imaging procedures, such as PET scan, may improve the ability to detect new or~     recurrent prostate cancer.~   "
257981|NCT00173329|"~     Lately researchers and clinicians have emphasized the health related quality of life. Several~     reasons account for this trend. First of all, the advanced medical practices have contributed~     to the increased life expectancy. Secondly, the pattern of diseases has shifted from high~     acuity to chronicity. Therefore, the effectiveness of health care could not be solely~     evaluated by the rates of morbidity and mortality. The state of patients’ quality of life has~     become the pivotal indicator of the effectiveness of health care interventions. On the other~     hand, patients’ subjective perceptions of health care are crucial factors in treatment~     processes. Therefore quality of life becomes reference in choosing health care interventions~     to enhance the benefits of patients.~      The scopes of quality of life research include the essence of quality of life, the~     measurements of quality of life and the relationships between quality of life and its related~     factors, etc. The local researchers have long put efforts in quality of life research. The~     results of these studies have contributed to the understandings of different patients’~     quality of life. However, the majority of studies have focused on specific diseases. This~     study propose to extend the scope of quality of life research to study patients’ quality of~     life of two severe illnesses, i.e. HIV infections and schizophrenia. These two illnesses~     represent two severe physical and psychiatric illnesses. Even their etiology, mechanisms,~     disease process, signs and symptoms, and treatments are different. However, the similarities~     of these two illnesses include both are severe illnesses without cure, both are stigmatized~     by the society. Patients with these two illnesses suffer in their personal lives, social~     relations and quality of life. Therefore the current study to further investigate and compare~     and contrast the essence of patients’ quality of life and their related factors.~      The proposed study is a second year study of the two-year study - The quality of life of~     patients with severe illnesses (NSC93-2314-B-002-294). The first year study focused on the~     investigation of the quality of life of patients with HIV infections (NSC93-2314-B-002-294).~     The aim of this proposed study is to compare and contrast the quality of life and its related~     factors of patients with schizophrenia and HIV infections. The contributions of this study~     include the in-depth understandings of quality of life of patients with HIV infections and~     schizophrenia and the comparison of quality of life of different illnesses. The results serve~     as the foundations in future development of intervention programs to enhance patients’~     quality of life and cost-effectiveness analyses.~   "
257982|NCT00173316|"~     The role of vascular endothelial growth factor-C (VEGF-C) and its receptors induced~     lymphangiogenesis and host inflammatory responses on the carcinogenesis of oral cancers and~     premalignant lesions~   "
257983|NCT00173303|"~     The purpose of this study is to evalute whether CAD (computer-aided detection) in FFDM~     (full-field digital mammography) can facilitate the detection rate of breast cancer on~     mammography compared with FFDM without CAD.~   "
257984|NCT00173290|"~     In this study proposal, the investigators will extend their previous studies and examine the~     kinetic cytotoxic activity with concordant expression of inhibitory natural killer (NK)~     receptors (iNKR) on activated T cells. The inhibitory role of cytokines will be defined by~     utilizing the investigators' previously established models of mixed lymphocytes and tumor~     cells coculture to analyze the expression and activity of cytokines involved in the~     regulation of iNKRs on cancer-encountered T cells.~   "
257985|NCT00173277|"~     BACKGROUND: Primary screening with sigmoidoscopy would miss a substantial proportion of~     advanced proximal neoplasia (APN), but screening with universal colonoscopy is costly. The~     aim of this study is to assess the efficacy of mixed strategy which uses sigmoidoscopy for~     younger patients and colonoscopy for older patients.~      MATERIALS and METHODS: We analyzed an established database containing consecutive~     average-risk adults aged 50 or older who underwent screening colonoscopy as part of health~     check-up. We assessed the efficacy of mixed screening strategy using colonoscopy for persons~     aged at and above a certain cut-off age and sigmoidoscopy for persons aged below that age.~     Those who underwent sigmoidoscopy initially would be referred for subsequent colonoscopy if~     distal sentinel lesion was detected.~   "
257986|NCT00173264|"~     The purpose of this study is to determine whether the monoclonal protein in patients with~     tuberculosis and monoclonal gammopathy has anti-tuberculous activity, and whether genes~     coding their monoclonal proteins show characteristic mutations.~   "
257987|NCT00173251|"~     There are more and more macromastic women in Taiwan, which may due to the high cholesterol~     foods. Patients with macromastia not only suffered from physical problems but also~     psychological discomforts.~   "
257988|NCT00173238|"~     Atherosclerosis is unquestionably the leading cause of morbidity and mortality in developed~     countries, and the world-wide importance of acute vascular syndromes is increasing. Rupture~     of atherosclerotic plaque has been identified as the proximate event in the majority of cases~     of acute ischemic syndromes. Therefore, modalities capable of characterizing the~     atherosclerotic lesion may be helpful in understanding its natural history and detecting~     lesions with high risk for acute events.~      Optical coherence tomography (OCT) is a powerful tool capable of tomographic imaging based on~     low coherence interferometry. It is analogous to ultrasound imaging except that it uses~     infrared light instead of sound. Polarization-sensitive optical coherence tomography (PS-OCT)~     combines the advantages of OCT with additional image contrast of the sample. The added~     contrast is based on the ability of PS-OCT to detect the birefringent properties of a sample~     (phase retardation and fast-axis orientation) simultaneously.~      The goals of this project are: 1) to examine whether PS-OCT is an acceptable tool for the~     characterization of typical plaque constituents; and 2) to explain the correlation between~     birefringence and forming or rupture of a plaque; and 3) to establish a quantitative PS-OCT~     image criteria for atherosclerotic plaque characterization in vitro.~   "
257989|NCT00173225|"~     The aims of this study are to investigate the association between sputum and plasma levels of~     nociceptin and substance P with cough severity and airway hyperreactivity in patients with~     asthma, COPD and chronic cough.~   "
257990|NCT00173212|"~     Adenomyosis refers to the presence of endometrial glands and stroma that is haphazardly deep~     within the myometrium. However, the etiology and pathologic mechanism responsible for~     adenomyosis are not yet very well known. Our previous results revealed that the expression of~     killer inhibitory receptors on natural killer cells was decreased in eutopic endometrium in~     women with adenomyosis. It implies that the formation of adenomyosis might be due to abnormal~     endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. Our~     further investigation revealed that in vitro coculture of macrophages and endometrial stromal~     cells (ESCs) increase the expression of IL-6 mRNA in ESC, which might further enhance the~     proliferation of ESC and subsequently result in the formation of ectopic endometrial implants~     in adenomyosis.~      Abnormal cell proliferation has been generally found in the tumorigenesis, including the~     formation of endometriosis. Adenomyosis is considered to have a similar pathophysiology with~     endometriosis, and it must be interesting to examine whether there is abnormal cell~     proliferation in the eutopic endometrium of adenomyosis. Lipopolysaccharide (LPS) was found~     to promote proliferation of ESCs via induction of TNF-a and IL-8 expression, whereas IFN-g~     significantly inhibited ESCs proliferation. Therefore, whether abnormal cell proliferation~     occurs under the effects of LPS and IFN-g in the eutopic endometrium of adenomyosis needs~     further clarification.~      Adenomyosis preferentially affects women between the ages of 35 and 50 years, and the~     symptoms subside gradually after menopause. It is well known that there is a close~     conjunction between estrogen and adenomyosis. Estradiol (E2) was demonstrated to induce~     endometrial cell proliferation, whereas medroxyprogesterone (MPA) inhibited endometrial cell~     proliferation via antagonizing estrogenic effects. Experiments to investigate these steroid~     effects on ESC proliferation in vitro in the eutopic endometrium of adenomyosis are of~     clinical relevance.~      In this study, we try to collect endometrial tissues from women with and without adenomyosis,~     and then purify ESCs from endometrium. ESCs are cultured for 2 days with the supplement of~     LPS, IFN-gamma, Estradiol, MPA and Estradiol+MPA. Quantification of cell proliferation was~     done with Cell Proliferation Assay Kit and immunocytochemical detection of Ki-67, in an~     attempt to examine the cell proliferation of ESCs in women with adenomyosis.~   "
257991|NCT00173199|"~     In order to increase our understanding about the pathogenic mechanism and the strategy of~     treatment in the subtypes of Guillain Barré syndrome, we will check the temporal changes of~     cytokines with different biological activities in serum and cerebrospinal fluid (CSF), check~     the titer of various anti-ganglioside antibodies, perform skin biopsy and correlate these~     data with the clinical findings such as severity and prognosis~   "
257993|NCT00173173|"~     This is the first-year part of a two-phase prospective study. The aims of the study are to~     investigate the prevalence rate of eating disorders in Taiwan, it's correlated psychosocial~     risk factors and establish the validity index of BITE. The study subjects consist of~     Taiwanese gifted dance high school students and age, sex, school-matched ordinary class~     students. All students completed questionnaires(Eating Altitude Test(EAT-26), Bulimic~     Investigatory Test, Ediburgh (BITE), Body Shape Questionnaire (BSQ), Physical Appearance~     Related Teasing Scale, Pubertal Develoment Scale, and Brief Symptom Rating Scale (BSRS) at~     first phase. All subjects who are above threshold (EAT-26 score≧20 and BMI≦17.5m2; the~     symptom scale score of BITE≧15 and/or severity scale≧5),and 10% of the sub-threshold cases~     need to receive second-phase interview by two senior psychiatrists. The contents of interview~     included SCID-IP, and risk factors assessment for eating disorders. The known risk factors~     included both personal factors (history of obesity, psychiatric, menstruation, teasing, or~     sexual or physical abuse, etc.) as well as family factors (parental problems, history of~     obesity, dieting, psychiatric illness etc.).~      Statistical analyses were conducted using SPSS 10.0 for Windows/PC. Categorical data were~     analyzed by nonparametric test (Chi-square test). ANOVA or Student’s t-test was used for~     continuous data analyses. Reliability is assessed by internal consistency and test-retest~     reliability. Inter-rater reliability was assessed by Kappa statistics. The sensitivity and~     specificity for eating disorders were calculated for individual screening instrument.ROC~     analyses were undertaken to evaluate the overall performance of the BITE +/- EAT in detecting~     eating disorder cases. Regression analysis was applied to determine predictors of disordered~     eating or eating disorder status. A value of P< 0.05 was considered statistically~     significant.~   "
257994|NCT00173160|"~     This is the second-year part of a two-phase prospective epidemiological study as well as a~     community case-controled study. The aims of the second year study are firstly, to investigate~     the clinical course and 1-year outcome of eating disorders in the community, as well as the~     prospective risk factors of eating disorders; secondly, a case-control design involving with~     other psychiatric disorders from the same study population is used for risk factors study.~      The study subjects are gifted dance high school students who participated the first-year~     study and are willing to participate the 2nd-year study (N=675). Screening questionnaires for~     eating disorders and general psychiatric disorders are EAT, BITE and CHQ-12. Other~     self-report questionnaires include perfectionism subscale of Eating Disorder Inventor-I~     (EDI), Rosenberg Self-esteem Scale (RSE), Eyseck Personality Scale, Pubertal Develoment~     Scale, and body figure test. Subjects who received interviews at the first-year study and~     those whose scores are above the threshold of the screening questionnaires need to receive~     interviews at 2nd phase. The criteria of interview threshold included EAT≧20+ BMI<18.5Kg/m2,~     symptom scale of BITE ≧15 and/or severity scale of BITE≧5, and CHQ ≧4. The content of~     interview included structured diagnostic interview (SCID-IP 1995) as well as risk factors~     assessment. Each time a subject with bulimia nervosa was recruited, one matched control~     subject with no mental illness general psychiatric diagnosis was sought from the same class~     or school. Potential psychiatric control subjects were identified from their scores on the~     CHQ. The psychiatric control subjects were required to have no current or past eating~     disorders. The contents of risk factor assessments include personal vulnerability and family~     problems.~      The relationships between individual risk factors and case status were assessed by univariate~     analysis. Conditional logistic analysis was used for multivariate analysis of risk factors~     prediction for eating disorders. To assess the relative importance of different types of~     exposure, the relationship between case status and exposure in each domain were first~     assessed by univariate analysis and then in multivariate stepwise regression analyses.~   "
257995|NCT00173147|"~     Background：Patellofemoral pain syndrome（PFPS） is a common knee disorder characterized by~     anterior or retropatellar pain associated with activities that load the patellofemoral joint.~     Previous studies reveal that the vastus medialis obliquus（VMO） is an important dynamic medial~     stabilizer of the patellar. Insufficiency of the VMO leads to lateral shift of the patella~     and the increases the patellofemoral contact force. An in vitro study conducted by Hubbard~     JK. et al. claimed that there were no significant relationship between several morphologic~     characteristics of the VMO and the extent of patellofemoral joint deterioration. We consider~     that the condition might be different in vivo, so we chose ultrasonogrphy as the measurement~     tool to examine the morphology of the VMO in PFPS patients and healthy controls. Purpose：To~     determine if there are significant differences in several morphologic parameters of the VMO~     between patients with PFPS and healthy controls under 50. Method：31 PFPS patients and 31~     matched healthy adults under 50 were recruited for the study. The HDI 5000 ultrasonography~     machine was used to evaluate morphologic parameters of the VMO, including the percent of~     patella attachment, fiber angle, the volume attached to the patella, and the change of shape~     of the VMO.~   "
257996|NCT00173134|"~     Adult diabetic patients aged above 20 attending the diabetic clinic of National Taiwan~     University Hospital are invited to attend a face to face screening and interview. After~     obtaining the informed consent, questionnaires including IIEF, DAN-PSS-SEX and erectile~     dysfunction effect on quality of lie are filled.Personal data, status of diabetes control and~     complications of diabetes are recorded.The results will be used to investigate the prevalence~     of erectile dysfunction of diabetic men in Taiwan and erectile dysfunction related quality of~     life change.~   "
257997|NCT00173121|"~     From last decades, because of lacking the powerful quantitative methods, such as real-time~     qPCR, there is no environmental monitoring data about enterovirus transmission. If the major~     transmission routes and risk factor are still not clear, it will be very hard for making the~     prevention and control strategies. Today, the most popular prevention suggestion for children~     is keeping them away from crowded public places during the peak contagious season, because~     enteroviruses are easily transmitted through aerosols over a distance of meters, and even~     between separated rooms (Chang et al., 2004). However, adults may as easily be infected, but~     don』t have any disease symptoms or carry the virus home. Another recommendation is washing~     hands to avoid contact of hands or anything else with the mouth and nose, as it is through~     contact of viruses with the mucosal membranes in the mouth and nasal passages that infection~     occurs. However, these actions did not be great helpful for preventing enterovirus infection~     and spread. Understanding and disrupting the major transmission pass way of enterovirus could~     be more effective than just keeping personal hygiene. Therefore, an applicable environmental~     monitoring program is needed for understanding the transmission routes and risk factor of~     enterovirus infection. In this study, we will monitor enteroviruses in hospital, household~     and kindergarten. For the environmental monitoring of enteroviruses, we will apply~     traditional plaque assay, real-time quantitative PCR and combine with questionnaire-based~     interviews to understand the infectious types and concentration of enterovirus from indoor~     air, surface and water for recognizing the transmission routes of enterovirus and the~     relationships between virus concentration and the symptoms of the cases.~   "
258062|NCT00172276|"~     Aims This study was conducted to examine the association between the ACE insertion/deletion~     (I/D) genotype distribution in children with idiopathic nephrotic syndrome and the response~     to steroid therapy.~      Patients and Methods The patients with idiopathic nephrotic syndrome were divided into 2~     groups according to their clinical response to steroid: SS group including infrequent and~     frequent relapsers and non-SS group including steroid resistant (SR) and steroid dependent~     (SD) patients. Children without previous renal diseases and negative proteinuria were~     enrolled as control group in genetic study. The genotypes for ACE gene I/D polymorphism~     including DD, ID and II were analyzed by the newly developed automatic denaturing high~     performance liquid chromatography system (DHPLC).~   "
271139|NCT00037388|"~     To establish a link among Chlamydia infection, sickle cell anemia, and stroke risk.~   "
257998|NCT00173108|"~     The first aim is to develop a clinic-based intervention program and a home-based intervention~     program for VLBW preterm infants that have common intervention services but are respectively~     delivered at clinic and home. The interventions are comprehensive that combine child- and~     parent-focused services including health and feeding consultation, education of child~     development skills, intervention of mother-infant interaction, and parent support. The~     eleven-session interventions are intensive that begin in hospitalization and end at 12 months~     of corrected age. The clinical feasibility and usefulness of implementing these intervention~     programs within the context of randomized intervention study subject to the existing~     constraints of the hospital and home settings will be tested in a pilot study.~      The second aim is to conduct a randomized control trial to examine the costs and~     effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and~     socio-economically matched normal full-term infants will also be included as a comparison~     group. Outcome measures that include child, parenting, and transactions outcomes will be~     compared between groups. Child outcome measures will include health status, growth,~     neurodevelopment, and neurosensory status; parenting outcome measures will include maternal~     parenting competence, social support, and psychological stress; transactions outcome measure~     will be mother-infant interaction. Costs (direct and indirect costs) associated with each~     early intervention program during the follow-up period will be estimated. Average and~     incremental cost/effectiveness ratio will be calculated to determine which early intervention~     program is most cost-effective for VLBW preterm infants.~   "
257999|NCT00173095|"~     According to Morgan et. al. (J Neurosurg 101:1026-1029, 2004): bilirubin as a cerebrospinal~     fluid marker of sentinel subarachnoid hemorrhage: a preliminary report in pigs, we're going~     to test the hypothesis in the cerebrospinal fluid of spontaneous subarachnoid hemorrhage~     patients.~   "
258000|NCT00173082|"~     Primary aldosteronism (PA) is occasionally associated with impaired glucose tolerance.~     Glucose intolerance, in general metabolic syndrome is caused by suppression of insulin~     release from the pancreas and suppression of insulin sensitivity of the target tissues.~     Several studies have suggested that impaired glucose tolerance in primary aldosteronism is~     due to an inability of the beta cells to release insulin by potassium depletion. It was~     suggested glucose intolerance in PA is caused by the suppression of insulin release related~     to hypopotassemia and compensatory increase of insulin sensitivity is observed in PA. The~     increased insulin secretory capacity associated with correction of negative potassium balance~     may account for the increase in plasma leptin after curing primary aldosteronism. The~     conclusion with respect to the possible causal relationship between diabetes mellitus (DM)~     and PA, however, can be obtained after the evaluation of the effect of surgical~     /pharmacological treatment of PA.~   "
258001|NCT00173069|"~     This PPG entitled “A Study on Psychopathological Progress of Early Schizophrenia-like~     Disorder (SOPRES)” is designed to study the “Progress of Psychopathology” of pre-psychotic~     state of schizophrenia (SCH) using a prospective follow-up design. Based on the~     neurodevelopment hypothesis of schizophrenia, the neurobiological dysfunctions, such as~     cognitive impairment, neurophysiological dysfunction, neuroanatomical pathology, is the core~     pathology. The pathology may exist prior to onset of psychotic symptoms, and at post~     psychotic state. It also presents in the first-degree relatives. SCH is mainly with a gradual~     mode of onset, ranging from pre-schizotypal (or pan-neurotic state), schizotypal, prodromal~     to frank psychotic SCH (DSM-IV criteria) state.~      Up to the present time, there are arbitray criteria for diagnosing schizotypal disorder and~     frank psychiatric schizophrenia, but the valid clinical assessment method of pre-schizotypal~     and prodromal state is still controversial. The psychopathological progress from~     pre-schizotypal to frank psychotic SCH state is still unclear. In this SOPRES, we intend to~     establish a set of valid clinical assessments for defining the cases of early SCH-like~     disorder [ESLD], to examine the clinical progression, such as conversion rate of psychosis~     from non-psychotic state in a prospective longitudinal follow-up; to validate the clinically~     defined cases of ESLD with different dimensions of neurobiological studies, including niacin~     skin flush test, neuropsychological, neurophysiological (such as prepulse inhibition [PPI],~     P50 inhibition [P50I]), and magnetic resonance spectrometry (MRS) and Diffusion Tensor~     Imaging (TDI); to demonstrate the validity of the ESLD using the family~     genetic-epidemiological data and to explore the awareness, reaction, coping strategy, social~     stigma, and help seeking process of the patients and the families of ESLD.~      In order to achieve these goals, we designed this PPG of SOPRES, which comprises of 4~     inter-locked projects and one core unit. Project No.1 is the “Clinical Phenomenological~     Follow-up Study of ELSD: Clinical Validity”; Project No. 2 is the “Validity Study of~     Neurobiological Tests of ELSD”; Project No. 3 is the “Validity Study of Family Genetic Study~     of ELSD”; and Project No. 4 is the “Awareness and Pathways of Help Seeking of ELSD”. The only~     one core unit is designed for the purposed of monitoring research progress, communication~     among researchers such managing PPG research meeting, data management, and budget management~     and other research-related administrative secretary work. These 4 projects are integrated~     study approaches by means of (1) using the same samples; (2) study different levels of~     psychopathology, including clinical symptoms, neurobiological impairment, family genetic~     data, and psychosocial variables; and (3) mutual hypothesis testing.~      We expect that this SOPRES research will create a new frontier of SCH research in the fields~     of early intervention of SCH for preventing the recurrence of frank psychotic state of~     schizophrenia, and will provide the background for improving treatment outcome and quality of~     life of SCH.~   "
258002|NCT00173056|"~     Peritoneal fibrosis (PF) is one of the most serious complications after long-term continuous~     ambulatory peritoneal dialysis (CAPD). Human peritoneal fibroblast (HPFB) and extracellular~     matrix (ECM) deposition is the most possible causes leading to PF. ECM are mainly synthesized~     from HPFB and human peritoneal mesothelial cells (HPMC). In the PF process, there is~     decrement in the quantity of HPMC, loss of permeability for lower molecules, and eventually~     ultrafiltration failure. This phenomena will result in technique failure.~      High glucose content of the dialysate and peritonitis have been claimed as major stimulants~     to the development of PF. In each episode of peritonitis, the number of HPMC will decrease.~     On the other hand, ECM production will be reinforced by the inflammatory cytokines secreted~     by the white cells or HPMC per se. High glucose dialysate will induce the above process with~     more chronic stimulation, and PF followed by technique failure is inevitable.~      Peritoneal fibrosis is definitively diagnosed with peritoneal biopsy, but this is~     inconvenient for most patients. Besides, pathology changes will be noted only after a~     substantial loss of peritoneal function. The peritoneal equilibration test (PET) is usually~     used as the index of peritoneal function. However, in the chronic process, PET change is also~     slow and is unable to be a parameter for treatment outcome. In this study, the factors~     predicting PET change will be searched, and they could be an index for evaluation and even a~     marker of preventing or treating PF.~      In this project, peritoneal dialysis (PD) dialysate will be collected during an annual PET in~     each PD patient in the National Taiwan University Hospital (NTUH). Some cytokines that will~     be measured include vasculoendothelial growth factor, hyaluronan, transforming growth~     factor-β, procollagen, and cancer antigen-125. The same test and measurement will be~     performed during PET in the next year. The factors which affect PET results will be analyzed~     such as cytokines, glucose exposure, peritonitis incidence, PD duration, gender, age. The~     investigators will try to find a convenient acute reactive marker for preventing or treating~     PF to monitor the PET change clinically.~   "
258070|NCT00172172|"~     This study is evaluating the effects of calcium supplementation on the efficacy and safety of~     recombinant parathyroid hormone (ALX1-11) in postmenopausal women with osteoporosis. The~     primary objective of this clinical study is to evaluate whether increases in bone mineral~     density (BMD) for subjects treated with ALX1-11 and receiving no calcium supplementation are~     less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium~     supplementation.~   "
258126|NCT00171444|"~     The purpose of the study is to determine whether a specific training of General Practitioners~     (Family Physicians) regarding the new official guidelines for the treatment of hypertension~     results in a higher control of high Blood pressure in their patient population.~   "
258127|NCT00171431|"~     Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern~     in female IBS-C patients.~   "
258003|NCT00173043|"~     Polycystic ovary syndrome (PCOS) phenotype can be structured into three components:~     anovulation, hyperandrogenism and the metabolic syndrome (of which hyperinsulinemia,~     secondary to insulin resistance, is the central abnormality)(1). It is the most common~     endocrinologic disease seen in Gynecologic clinic. The follicular excess in polycystic~     ovaries and the failure of selection of one dominant follicle contribute to the anovulation~     of PCOS. The infertile PCOS female usually suffered from difficult ovulation induction and~     high risk of ovarian hyperstimulation syndrome because of extensive stimulation.~      PCOS is the main androgen disorder in women and has been suggested to be associated with a~     high risk of developing cardiovascular disease and type-2 diabetes. In many PCOS patients,~     overweight or central obesity is generally associated with increases in fasting insulin~     levels, insulin resistance, and glucose intolerance, and has been identified as a target for~     new therapeutic strategy, including early change in lifestyle.~      Insulin resistance, defined as decreased insulin-mediated glucose utilization, is commonly~     (10-25%) found in the normal population. In women with PCOS, insulin resistance appears even~     more common (up to 50%), in both obese and non-obese women.Hyperinsulinemia appears to play a~     key pathogenic role in the ovarian androgen overproduction, because of the stimulatory effect~     of insulin on ovarian steroid production.~   "
258004|NCT00173030|"~     Multi-locus and multi-gene studies of atrial fibrillation, focusing on renin-angiotensin~     system genes and C reactive protein gene~   "
258005|NCT00173017|"~     Wearing N95 masks may have adverse physical effect on medical staff~   "
258006|NCT00173004|"~     Genetic studies of hypertension, focusing on renin-angiotensin system genes and other~     interacting genes~   "
258007|NCT00172991|"~     Genetic studies of coronary artery disease, restenosis after angioplasty or stenting,~     focusing on renin-angiotensin system genes and adiponectin gene, and their interactions.~   "
258008|NCT00172978|"~     To study the effect of elective pain relief analgesia in labor on mode of delivery.~   "
258009|NCT00172965|"~     Diagnosis of oral precancers and cancers using optic coherence tomography~   "
258010|NCT00172952|"~     To study the clinical characteristics and inheritance of pathological myopia in Taiwanese~     patients.~   "
258011|NCT00172939|"~     This current three-year proposal aims to clarify the mechanisms of melanocyte destruction and~     regeneration in vitiligo lesions using both traditional cell culture and skin equivalent~     model (organotypic culture).~   "
258012|NCT00172926|"~     Physical constitution is an important factor for the development and outcome of diseases~     according to the theory in traditional Chinese medicine.~      The purpose of the study is to find the correlation between physical constitution and~     clinical characteristics (age, sex, symptoms, physical signs, life style, laboratory results~     and image findings) through the questionnaire and results of health examination.~   "
258013|NCT00172913|"~     In the interest of improving visual quality after LASIK we have designed a multifaceted study~     to test the theoretical, physical, biomechanical and functional effects of commercial and~     independently designed aspherical ablation profiles.~   "
258014|NCT00172900|"~     The white matter change of the Alzheimer's disease could be studied by diffusion tensor image~     and MR spectroscopy to see the microstructral and biochemical change.~   "
258015|NCT00172887|"~     The quantity and quality of inpatient services for persons with psychiatric illness have been~     enhanced in the last two decades. Following the enforcement of nationwide health insurance~     and the Physically and Mentally Disabled Citizens Protection Act, the financial pressure of~     medical care for psychiatric patients is relieved, and actions related to the protection of~     patients' human rights have been taken. Nonetheless, problems related to psychiatric illness~     are not limited to symptoms. Patients' daily functions are affected and it causes continuous~     pressure on the family. Currently, psychiatric care places more emphasis on inpatient~     services. Once the patient is discharged from the hospital, related psychiatric services are~     not widely available, which leads to symptom exacerbation, repeated hospital admissions,~     increased burden to the family, etc. A provision of continuous long-term care that meets the~     various needs of psychiatric patients is a critical issue in current psychiatric care.~      Based on a three-phase needs assessment model, the purpose of the study is to evaluate the~     needs of long-term care for psychiatric patients. The first phase will identify the current~     status of needs from the perspectives of patients and the family, psychiatric professionals,~     and the system. The second phase will identify the goals of long-term care for psychiatric~     patients. The goals will be identified by a nominal group, composed of experts related to the~     field of psychiatric long-term care. The third phase will determine the objectives of~     long-term care services for psychiatric patients. That is to determine the proper contents of~     long-term care services for the patients based on the goals identified in the previous phase.~      The three-phase needs assessment will be carried out in a two-year period. The results of the~     study will provide important information to the future planning of long-term care for~     psychiatric patients.~   "
258016|NCT00172874|"~     The aim of the study is to understand the clinical characteristics of Taiwanese eating~     disorders as well as establishment of the psychometric properties of eating disorder-related~     questionnaires (EDI and BITE).~   "
258017|NCT00172861|"~     Background:~      Gastric carcinoma (GC) remains among the most frequent malignancies in Taiwan as well as in~     the world and also one of leading causes of cancer-related death. Accumulating evidence shows~     that chronic inflammation leads to the occurrence of cancers, including GC, via multiple~     mechanisms.~      Cyclooxygenase-2 (COX-2) is a crucial enzyme in inflammatory process and is shown to be~     up-regulated in a variety of cancers. Therefore, COX-2 may play an important role in~     carcinogenesis. The hallmarks of cancer include continuing proliferation, evading apoptosis,~     prohibiting immunity, promoting angiogenesis, enhancing invasion and metastasis. We~     hypothesize that COX-2 induces carcinogenesis through multiple mechanistic strategies and~     interactions of multiple genes simultaneously.~      Laser capture microdissection (LCM) for obtaining pure cancer cells and microarray technology~     and analysis are now generally accepted as powerful tools in genomic research, providing~     reliable microdissection of cancer cells and simultaneous analysis of whole genome.~      Aim:~      Use microarray technology to investigate patterns of genomic change related to differential~     COX-2 expression and their clinicopathological association in GC.~      Materials:~      GC cell lines are transfected with COX-2-expressing vector to establish cell lines with~     differential levels of COX-2 expression. Clinical specimens are obtained from surgical~     resection of GC proved by pathology at the Surgical Department of National Taiwan University~     Hospital, which COX-2 expression is evaluated by Western blotting and immunohistochemical~     staining.~      Methods:~      The present project will use microarray for analysis of genome clustering patterns of~     surgical tissue (GC cells procured by LCM) and GC cell lines based on differential COX-2~     expression levels, to discover significantly positively or negatively associated gene~     clusterings which contain candidate genes for studies of carcinogenesis mechanisms and~     establishment of animal experiment models in another component project.~      Execution:~      In the first year of this 3-year project, we will establish GC cell lines expressing~     differential COX-2 levels by transfection of COX-2-expressing vector and focus on analyzing~     their genomes by microarray. We also start to collect surgical specimens of GC, record~     clinicopathological characteristics, procure cells by LCM and assess RNA quality, perform~     microarray experiments. In the second year, we will continue LCM, RNA extraction, and~     microarray experiments. In the third year, microarray experiment of a total of 60 pairs,~     including 30 high-COX-2 cases and 30 low-COX-2 cases, of tumor and non-tumoral tissues are~     completed. Final analysis is carried out to identify clustering, to select candidate genes,~     and investigate their relationship to clinicopathological characteristics, according to COX-2~     expression. These genes are to be subjected to mechanism and animal studies. We expect a~     better understanding of patterns of gene clustering in differential COX-2 gene expression.~   "
258090|NCT00171912|"~     This trial is for various types of malignancies which may depend on certain enzymes (tyrosine~     kinases) for growth. The objective of this study is to assess to what extent imatinib~     mesylate blocks these enzymes and to assess the effect on the malignancy.~   "
271140|NCT00037375|"~     To investigate the relationship of childhood lifestyle and physical characteristics to~     prevalent asthma.~   "
258018|NCT00172848|"~     The purpose of this study was to discuss the relation of mastery, social support and~     depression in patients with depressive disorder. Cross-sectional quantitive study and~     purposive sampling method were designed. Data collection and analysis was conducted through~     structural questionnaires (including demographics, social support scale, mastery scale, CESD~     scale) at a medical center in Taipei. Results showed that patients with depression whose~     degree of depression was negative correlated with mastery and social support, and mastery was~     positive correlated with social support. Regression statistics results showed that mastery,~     social support, age, loss of jobs can predict degree of depression up to 60 percent. The~     mastery was strongest independent predictable factor to degree of depression, and had partial~     or total mediate effects to age, loss of jobs, financial condition, and social support. The~     result of this study suggested that clinically the care of patients with depression should~     focus on their confidence in mastery and provide strategies to promote their confidence in~     mastery, which can effectively reduce the degree of depression of those patients.~   "
258019|NCT00172835|"~     Among several markers of inflammation and sepsis, procalcitonin (PCT) markers is being~     studied to investigate their accuracy for the diagnosis of bacterial infections. PCT is the~     prehormone of calcitonin, which is normally secreted by the C cells of the thyroid in~     response to hypercalcemia; under these normal conditions, negligible serumPCT concentrations~     are detected. The mechanism proposed for PCT production after inflammation and its role are~     still not completely known. It is believed that PCT is produced by the liver and peripheral~     blood mononuclear cells, modulated by lipopolysaccharides and sepsis-related cytokines. It~     binds to polysaccharides in pathogens, activating the classical complement pathway. The~     reported diagnostic accuracy of PCT for the diagnosis of bacterial infections has varied~     across studies.~   "
258020|NCT00172822|"~     prospective study to collect data of patients with appendicitis, not receiving operation~   "
258021|NCT00172809|"~     The treatment response with conventional interferon alpha alone in patients with end stage~     renal disease and chronic hepatitis C is about 33-39%. However, the drop-out rate is~     17-29.6%. Pegylated interferon alpha, a newly developed form of interferon with superior~     pharmacokinetic profiles, has not been used to treatment these patients. We expect the better~     treatment response treated with peginterferon alpha than conventional interferon. In~     addition, we also observe the safety of the two drugs during the study. The goal of the study~     is to compare the efficacy and safety of the two different treatment regimens in patients~     with chronic hepatitis C and end stage renal disease.~   "
258022|NCT00172796|"~     We, the investigators at National Taiwan University Hospital, want to compare patients' islet~     cell function, insulin sensitivity and risk of chronic complications with normal subjects.~     Moreover, we want to examine whether they are at a higher risk of having metabolic syndrome~     and to answer whether we should screen the phenotypes of metabolic syndrome in impaired~     fasting glucose (IFG) and impaired glucose tolerance (IGT) patients. Then, we want to examine~     the association between insulin sensitivity and islet functions.~   "
258023|NCT00172783|"~     To investigate the size of PPD and TB specific ELISPOT among children between 3m/o and 15 y/o~     . Calculate the normal range of age specific PPD size in children who recieved BCG at~     new-born period.~   "
258024|NCT00172770|"~     Schizophrenia is a severe mental illness, which has a prodromal phase of 1-2 years prior to~     the onset of the illness. During the prodromal phase, patients might show maladaptation~     and/or poor social functioning. However, these early symptom of schizophrenia might be~     overlooked by patients and their families. At that period, patients might strive to improve~     their social interactions and social functioning. However, the efforts might further create~     their stress level on everyday life, which can actually accelerate the illness onset of~     schizophrenia. In other words, the efforts would worsen the pathophysiologic changes in the~     brain, which can result in the positive symptoms of schizophrenia.~      Previous researches found that the critical period for treatment of schizophrenia is the~     early phase of illness onset, especially the first two or three years. Delay treatment would~     worsen the illness. To this extent, early treatment would bring to a better prognosis as well~     as minimize the costs of individuals, families and society. In other words, early~     interventions not only can prevent relapse, it also can benefit patients’ psychosocial~     adjustments. However, researches found that the average duration of untreated psychosis is~     25.2 months in Taiwan, which indicates the phenomena of delay treatment and this trend might~     result in missing the critical treatment period.~      This is a two years study aiming to establish an early intervention program for patients with~     schizophrenia. In the first year, it aims to understand the phenomena of psychiatric care~     services utilization for patients with schizophrenia, special emphasis will be on the delay~     treatment and pluralistic health seeking process. In the second year, it aims to establish an~     early intervention program. The results of this research would contribute to in-service~     trainings, service providing, and policy making of psychiatric services.~   "
258025|NCT00172757|"~     We will explore the genetic (including APC, k-ras, p53, MSI, etc.) and environmental~     (including family history, life style, diet, nutritional status, DM, serum IGF-I, IGFBP-3,~     etc.) risk factors of colorectal tumorigenesis. We will accrue approximately 1000 patients as~     experimental group. The control group consists of 2000 individuals who were confirmed without~     colorectal cancer or polyps by colonoscopy. We estimated the statistical power of this study~     will reach more than 90%. In the second year, we will explore the association between various~     environmental risk factors with the epigenetic changes of various oncogenes and tumor~     suppressor genes. Firstly, we will study the correlation between hypermethylation of promoter~     region of hMLH1 gene with various environmental factors. Next, we will explore the genetic~     polymorphisms of promoter of E-cadherin gene. Recently, it has been reported that the C→A~     genetic polymorphism in the promoter region of E-cadherin gene in prostate cancer. Since this~     phenomenon has not been reported in colorectal cancer, it is mandatory for us to extend our~     research to the E-cadherin polymorphisms of colorectal cancer. Moreover, this project will~     focus on exploration of the association between the genetic polymorphisms of promoter of TS~     gene with chemosensitivity to 5-Fu-based therapy. We speculated that the better prognosis in~     colorectal tumors with MSI is related to their expression of TS gene. In summary, the second~     year of this project will extend our accumulated experience in the study of genetic~     polymorphisms to further clarify the association between genetic polymorphisms of TS gene~     with the prognosis of colorectal cancers after chemotherapy. We believe that this project~     will facilitate: (1) the further clarification of colorectal cancer tumorigenesis; (2) the~     establishment of domestic epidemiological data of colorectal cancer of Taiwan, and (3) the~     improvement of the quality of clinical management of patients with colorectal cancer.~   "
258026|NCT00172744|"~     The purpose of this study is to observe cyclic tensional force on the osteogenic~     differentiation of human periodontal ligament stem cells.~   "
258091|NCT00171899|"~     The study will assess the role of high-dose imatinib mesylate, in patients who have taken~     imatinib mesylate for at least 1 year at the standard dose, in achieving a major molecular~     response (a measure of the level of chronic myelogenous leukemia) versus the standard dose.~   "
258092|NCT00171886|"~     Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH)~     hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is~     associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor,~     suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.~      This study will evaluate the safety and efficacy of octreotide as primary therapy for the~     treatment of acromegaly and as therapy for patients with acromegaly and a pituitary~     macroadenoma or microadenoma.~   "
258093|NCT00171873|"~     Placebo-controlled prospective randomized phase III study to investigate the~     antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of~     the midgut~   "
258027|NCT00172731|"~     The purpose of the study is to develop a questionnaire on community occupational~     participation for persons with schizophrenia living in the community. In the International~     Classification of Functioning, Disability, and Health (ICF) recently revised by World Health~     Organization, activity participation is recognized as an important indication of~     health-related status. From the perspective of occupational therapy, the researcher intends~     to investigate the experiences of occupational participation among schizophrenic patients~     living in the community, and to develop a measuring tool for occupational participation~     accordingly.~      The development of the Community Occupational Participation Questionnaire will be based on~     the result of a qualitative research project which the researcher is carrying out at the~     moment. The resultant questionnaire will provide a quantitative measure of community~     occupational participation for persons with schizophrenia, as well as a measurement tool of~     activity participation for health-related research studies. Furthermore, it may provide~     valuable information to the development of community psychiatric services.~      This current study will take one year. Tasks to be accomplished include: building item pool,~     examining content validity of each item, pilot testing, item analysis, norm establishment,~     and testing reliability and validity. Data will be collected in different areas of Taiwan,~     and will be analyzed with the following methods: content validity ratio, item-total~     correlation, Cronbach’s alpha, and confirmatory factor analysis. The study will result in an~     occupational participation questionnaire with norm, validity and reliability.~   "
258028|NCT00172718|"~     Osseointegrated root form implants have been applied successfully in treating fully and~     partially edentulous patients and patients with single tooth missing. However, the success~     rate of osseointegrated dental implants was not as good in patients with poor bone quality.~     The reasons are believed that poor bone quality reduces the initial stability of dental~     implants and then reduces the success rate. For increasing initial stability of dental~     implants, some technical modifications are suggested in literature. However, due to lack of~     an objective method to evaluate bone quality, they are controversial. The purposes of this~     clinical study are to develop a standard procedure which using cutting resistance measured by~     Osseocare in surgery to evaluate the bone quality and to compare with the clinical~     experiences of oral surgeons. The objective outcome, initial stability of dental implant, is~     measured with Osstell. The analyzed results are also helpful for less experienced surgeons.~   "
258029|NCT00172705|"~     This study is proposed to explore the correlation between fatty content of fatty liver and~     the difference of CT attenuation value in men using dual-energy CT, and to set up a threshold~     for diagnosis of fatty liver.~   "
258030|NCT00172692|"~     Soft food chewing does not require strong bite force. The number of chewing strokes and~     occlusal surface area of the posterior teeth are more important. Clinically, reduction of~     occlusal surface to protect the abutments of a fixed or removable partial denture or the~     implant supported teeth is often necessary. If a certain chewing ability is maintained with~     reduced occlusal area, changing chewing velocity might help. For this hypothesis, the effect~     of chewing velocity on soft food chewing ability would be observed first. The purpose of this~     study is to evaluate the deliberately changed chewing gum chewing velocity on the chewing~     ability of healthy subjects whose dental occlusal surface area is known. Twenty dental~     students (10 men and 10 women with an age range of 20-30 years) with healthy masticatory~     systems and complete dentition will be asked to chew HA containing chewing gum with habitual~     side teeth at the cycle time of 0.5 sec, 1.0 sec and 1.5 sec for 30, 40, and 50 times. Jaw~     movement, tooth contact, and muscle activities will be observed during chewing gum chewing.~     The distribution of HA particles in the gum bolus after each chewing session will be measured~     and regarded as the chewing efficiency of that subject. Occlusal surface area of the~     maxillary posterior teeth, chewing rate, chewing time, muscle activity and jaw lateral~     displacement will be related to the chewing efficiency with multiple regression analysis. The~     effects of practice due to changing of chewing rate will also be evaluated.~   "
258031|NCT00172679|"~     Tai Chi is a traditional Chinese martial art that has been practiced for many centuries.~     Improvements in cardiorespiratory function, balance, muscular strength, flexibility in older~     subjects; preventing falls in the frail elderly; stress reduction, and mood state with Tai~     Chi practices have been well established. A potential immune response effect of Tai Chi~     practice is a frequent claim; however, this is an under-researched area. Therefore, in this~     study, the researchers will examine the effects of Tai Chi on innate and adaptive immune~     function.~   "
258032|NCT00172666|"~     Although SLE and RA are correlated with genetic predisposing factors such as human leukocyte~     antigen (HLA) class II, both diseases and other genetic factors might have contributed to the~     development of dysregulated lymphocyte activation and autoimmunity.~      Decoy receptor 3 (DcR3)/TR6 is a secreted protein belonging to the tumor necrosis factor~     (TNF) receptor family. It binds to Fas ligand (FasL), LIGHT, and TL1A that are all TNF family~     members. It was noted that soluble or solid phase DcR3-Fc co-stimulated proliferation,~     lymphokine production and cytotoxicity of mouse and human T cells upon T-cell receptor (TCR)~     ligation. Recently, the investigators found that the serum level of soluble DcR3 was higher~     in SLE patients than in healthy control subjects (unpublished data). Taken together, the~     investigators propose that in autoimmune diseases, such as RA and SLE, activated T cells~     secrete more DcR3 than non-autoimmune controls, which may, in turn, costimulate T cells~     further and cause dysregulated lymphocyte activation. With the aim to establish the possible~     correlation between DcR3 genetic polymorphisms, DcR3 expressions, and autoimmune phenotypes,~     the investigators offer this proposal. They plan to investigate the single nucleotide~     polymorphisms (SNPs) in the DcR3 gene. The genetic polymorphisms on the DcR3/TR6 gene and~     circulating DcR3 level will be compared between RA, SLE and non-autoimmune control subjects.~   "
258094|NCT00171860|"~     The objectives of the study are:~        1. Evaluation of the safety profile of imatinib mesylate in patients with idiopathic~          hypereosinophilic syndrome resistant or refractory to, or intolerant of, prednisone,~          hydroxyurea or interferon-alpha, or untreated patients carrying the Fip1L1-PDGFRA fusion~          protein.~        2. Evaluation of the efficacy of imatinib mesylate in patients with idiopathic~          hypereosinophilic syndrome~        3. Analysis of patient's blood samples for the detection of activated kinases.~   "
258095|NCT00171847|"~     Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in~     metastatic breast cancer patients~   "
258033|NCT00172653|"~     Background:~      Shoulder-related dysfunction (SD) is a common health problem in various patient populations.~     SD can affect an individual's ability to function independently, consequently decreasing~     quality of life. A battery of simple measurable function-related tests for patients with SD~     is important.~      Objective:~      The purpose of this study is to test the reliability, validity, and potential clinical use of~     a battery of function-related tests in patients with SD. Additionally, the biomechanical~     characteristics of the battery of function-related tests will be analyzed in terms of~     three-dimensional shoulder complex movements and associated muscular activities.~      Design:~      Repeated measurements and descriptive study~      Methods:~      The affected arms of 60 symptomatic patients with SD will be assessed by two clinicians as~     well as by one clinician twice to calculate intertester and intrarater reliabilities.~     Assessment will include self-report measures and the battery of function-related tests~     (hand-in-neck, hand-to-scapula, hand-to-opposite-scapula, and modified Kibler's lateral~     scapular slide test). Pearson correlation or Spearman's rho correlation coefficients will be~     calculated and the correlation matrices will be examined for evidence of convergent and~     discriminative validity among pain, disability, and function-related measures in patients~     with SD. Principle axis factor analysis will be performed on the kinematic measurements and~     muscular electromyography (EMG) activities to characterize the factor loading of each task.~   "
258034|NCT00172640|"~     Hepatocellular carcinoma (HCC) is one the most common malignancies in the world, especially~     in sub-Saharan Africa and Southeast Asia. Since 1984, it has been the leading cause of cancer~     death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. DNA~     microarray (DNA chip) is a very powerful tool to clarify the genetic changes in cancers.~     Expression profiling techniques have been used to simultaneously monitor the expression of~     thousands of genes from human tumor samples. It has been successfully used to predict~     clinical outcome and survival as well as classify different types of cancer. In this study,~     we will use the DNA chip to study the genetics in liver cancer patients.~   "
258035|NCT00172627|"~     Evidence is rapidly accumulating that chronic inflammation may contribute to carcinogenesis~     through multiple mechanisms in a number of malignancies, including gastric carcinoma (GC).~     Cyclooxygenase-2 (COX-2), an inducible enzyme pivotal in the inflammatory response, converts~     arachidonic acid to the prostaglandins (PGs) required in initiating and maintaining reactions~     during the inflammatory process. Over-expression of COX-2 has been reported in a wide variety~     of cancers and is therefore implicated to play an important role in carcinogenesis. COX-2 can~     be blocked by non-steroidal anti-inflammatory drugs (NSIADs) and is currently the most~     studied therapeutic target of NSAIDs. Clinically, NSAIDs have long been used to treat various~     inflammatory or rheumatologic disorders.~      Earlier clinical studies have confirmed an association between COX-2 over-expression and GC~     occurrence. The known mechanisms by which COX-2 promotes carcinogenesis include evasion from~     apoptosis, suppression of immunity, promotion of angiogenesis, and facilitation of~     invasiveness. However, inflammation-associated factors mediating the effects of COX-2 on~     carcinogenesis remain largely unknown. Interleukin-6 (IL-6) is a pro-inflammatory cytokine~     associated with gastritis and GC. Our earlier works has disclosed that IL-6 can promote~     angiogenic and anti-apoptotic ability of GC. However, the relationship between COX-2 and IL-6~     in GC remains unknown.~      The present study aims to investigate the clinical association between COX-2 and IL-6 in GC,~     to use a GC cell model for experimental study on causation and mechanism, and to verify the~     in vivo effect of COX-2 on IL-6 by an animal model.~      We will collect 100 consecutive surgical samples of GC from the pathology archive of National~     Taiwan University Hospital and use immunohistochemical stain to compare protein expression in~     GC. The clinical study is to define certain subgroups of GC exhibiting an association between~     COX-2 and IL-6. In experimental study, we will clarify the causal relationship by the dose-~     and time-dependent experiments of COX-2 transient transfection in a GC cell line. COX-2 acts~     mainly via PGs, like PGE2. Therefore, we also stimulate GC cells with exogenous stimulation~     of PGE2 and EP receptor 1-4 agonists to determine the possible way(s) by which COX-2 induces~     IL-6 expression. A selective COX-2 inhibitor NS-398 and various inhibitors of PGE2 receptors~     are used as well to block COX-2 for determining the signaling pathway of COX-2 on IL-6.~     Finally, we will establish a stable COX-2 over-expressing transfectant of GC cells and its~     control vector transfectant for xenograft implantation study on mice. A COX-2 selective~     agent, celecoxib, will be administered orally to mice and tumor blocks will be harvested for~     determination of IL-6 expression.~      The present study will provide clearer understanding of the role of COX-2 on the~     pro-inflammatory cytokine IL-6 in GC in both clinical and basic aspects. It might also stand~     for a model capable of systemically investigating the role of COX-2 on various cytokines~     implicated in GC.~   "
258036|NCT00172614|"~     Insulin resistance and disturbances in energy homeostasis are associated with body weight~     changes, such as diabetes, hypertension, hyperlipidemia, obesity, cancer cachexia, aging, and~     acute or chronic infectious diseases. Cytokines secreted by adipose tissue and inflammatory~     cells play important roles in the pathological conditions. Several novel cytokines were~     disclosed recently, but their functions have not been well known. Further investigation of~     these cytokines, resulting in insulin resistance and energy homeostasis, is very important to~     elucidate the mechanisms and develop new therapeutic strategies.~   "
258037|NCT00172601|"~     Background: Frozen shoulder syndrome (FSS) or adhesive capsulitits, a condition of uncertain~     etiology characterized by a progressive loss of both active and passive shoulder motion, is~     one of the most common musculoskeletal disorders encountered in daily orthopaedic practice~     and remains challenging to treat. To regain the normal extensibility of shoulder capsule and~     tight muscular tissues, passive stretching of the shoulder capsule by means of mobilization~     techniques has been recommended, but limited data for supporting the use of these treatments~     are available. Due to the performance of techniques (mid-range/end-range mobilizations~     combined with or without interscalene brachial plexus block), a lack of objective and~     subjective outcome criteria, an inappropriate research design (case report and clinical trial~     without control), and utilization of other treatment modalities (home exercises and hot/cold~     packs), it is not possible to draw firm conclusions about the efficacy of mobilization in~     patients with FSS. Objective: The aim of our study is to investigate the effect of~     mobilization treatment and to determine whether a difference of treatment efficacy exists~     among three mobilization techniques (mid-range mobilization, end-range mobilization, and~     mobilization with movement) in patients with FSS. Design: We will carry out a crossover~     multiple-treatment trial on two groups. In group one, an A-B-A-C (A: mid-range mobilization,~     B: end-range mobilization, C: mobilization with movement) multiple-treatment design will be~     used. In group two, an A-C-A-B multiple-treatment design will be used. There will be three~     weeks of each phase. An independent trained outcome assessor, blinded to treatment~     allocation, will evaluate the participates at baseline and at 3-week intervals for 12 weeks.~     Outcome assessment include pain perception, disability assessment, and Shoulder complex~     kinematics and associated muscular activity. Analysis of covariance (ANCOVA) will be~     undertaken using the follow up data at 3, 6, 9 and 12 weeks for each of the outcomes, with~     adjustment for the baseline values of the outcome of interest. Independent t-Tests will be~     conducted to compare change of outcome variables between two groups (A-B in one group vs. A-C~     in the other group, A-C in one group vs. A-B in the other group).~   "
258038|NCT00172588|"~     Our previous results revealed that the expression of killer inhibitory receptors (KIRs) on NK~     cells was decreased in eutopic endometrium in women with adenomyosis. It implies that the~     formation of adenomyosis might be due to abnormal endometrial tissues, but not the aberrant~     local immunological dysfunction in myometrium. In addition, in vitro coculture of macrophages~     and endometrial stromal cells (ESC) increase the expression of IL-6 mRNA in ESC, which might~     further enhance the proliferation of ESC and subsequently result in the formation of ectopic~     endometrial implants in adenomyosis. Besides, another possible mechanism is the abnormal~     apoptosis of ESC in adenomyosis. In endometriosis, apoptotic endometrial cells were found to~     be decreased, which possibly accounts for the formation of endometriosis. However, there have~     not been reports investigating the apoptosis of ESC in adenomyosis.~      In this study, we try to investigate apoptotic ESC with flow cytometry in women with and~     without adenomyosis. Annexin V, bcl-2, and caspase-3 were measured to represent the degree of~     apoptosis in ESC.~   "
258039|NCT00172575|"~     The purpose of our study is to determine whether contrast-enhanced dynamic MRI (DCE MRI)~     analysis of tumor angiogenesis and perfusion can be used as a reliable modality to~     differentiate benign from malignant solitary pulmonary nodules (SPN) before surgical~     intervention, using kinetic model derived from DCE MRI, and further correlate if there is any~     positive correlation between angiogenesis factor (vascular endothelial growth factor VEGF,~     microvessel density MVD); and if the perfusion parameters from DCE MRI can predict patients’~     outcomes and survival.~   "
258096|NCT00171834|"~     The study objective is to evaluate the maximum tolerated dose, safety and efficacy of~     patupilone in patients with NSCLC who have progressed after prior chemotherapy.~   "
258097|NCT00171821|"~     This study uses a single arm, multi-center, open-label trial design. The study will assess~     the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with~     evidence of transfusion induced iron overload.~   "
258098|NCT00171808|"~     In Western industrialized countries, endometrial cancer is the most common malignancy of the~     female reproductive tract.~      The general therapy options are surgery, radiotherapy, chemotherapy and endocrine therapy.~     This trial will investigate the efficacy and safety of letrozole in the treatment of advanced~     or recurrent hormone receptor-positive endometrial cancer .~   "
258099|NCT00171795|"~     This study is designed to investigate the efficacy and safety of rivastigmine compared with~     placebo in patients with traumatic brain injury and cognitive impairment.~   "
258040|NCT00172562|"~     In malignant or neoplastic disease, angiogenesis is defined as the generation of new~     capillaries from preexisting blood vessels, e.g. by sprouting or by intusseption. Through the~     pioneering work of Folkman, it was recognized that angiogenesis plays an important role in~     tumor development, progression, and metastasis. It is also conceivable that there are forms~     or developmental stages of leukemia, multiple myeloma, or lymphomas that will progress~     independently of angiogenesis. Synthesis of angiogenesis activators, such as vascular~     endothelial growth factor (VEGF) and other angiogenic factors, such as basic fibroblast~     growth factor (bFGF), has been demonstrated for leukemia cells, non-Hodgkin’s lymphoma, and~     myeloma cells. Microvessel density is also significantly elevated over normal controls with~     progressive increases according to the stages of myelodysplastic syndrome. Increased~     microvessel density (MVD) in the bone marrow was found in patients with multiple myeloma in~     comparison to normal controls and increased MVD is an adverse prognostic marker in multiple~     myeloma. However, the functional status of the blood vessel (e.g. permeability) cannot be~     determined by the above mentioned methods.~   "
258041|NCT00172549|"~     The purpose of this study was to explore the quality of life and its related factors of~     patients with major depressive disorder. This study adopted cross-sectional research design.~     Purposive sampling was used to collect data from 120 patients came from the psychiatric~     outpatient departments of a medical center and a psychiatric hospital in northern Taiwan.~     Data were collected through structured questionnaires, which included：(1) demographic data~     sheet, (2) 5-item Brief Symptom Rating Scale (BSRS-5), (3) the Center For Epidemiologic~     Studies Depression Scale(CES-D), (4) Inventory of Socially Supportive Behaviors(ISSB), (5)~     World Health Organization’s Questionnaire on Quality of Life：BREF-Taiwan Version~     100(WHOQOL-BREF). Data were analyzed by using SPSS/Windows 10.0 statistical software. The~     descriptive statistics methods included frequency distribution, arithmetic mean, standard~     deviation, and percentage. Data were analyzed by using independent t-test, Pearson’s~     product-moment correlation, one way ANOVA and stepwise multiple regression and so on, with~     which we can examine the demographic, degree of depression, social support and their links to~     the quality of life. Through the research, we found out the following results：~      1.The condition of major depressive disorder patients’ quality of life is score range of each~     subtitle from 4-20. A sum from the following subtitles：physical domain is 11.54,~     psychological domain is 10.46, social domain is 11.61 and environmental domain is 12.82. The~     quality of life results is higher of environmental domain, which is poorer of psychological~     domain.~      2. The results of quality of life related to demographic, degree of depression, social~     support were as followed：~        1. Physical domain：the independent variables of significant linear correlation is age, the~          age of early-onset, type of occupation, living arrangements, economic status, health~          status, the degree of depression and emotional support.~        2. Psychological domain：the independent variables of significant linear correlation is age,~          the age of early-onset, type of occupation, living arrangements, economic status, health~          status, the degree of depression, the sum of social support, emotional support,~          instrumental support, informational and appraisal support.~        3. Social domain：the independent variables of significant linear correlation is age, the~          age of early-onset, marital status, type of occupation, economic status, health status,~          the degree of depression, the sum of social support, emotional support, instrumental~          support, informational and appraisal support.~        4. Environmental domain：the independent variables of significant linear correlation is age,~          the age of early-onset, marital status, economic status, the degree of depression, the~          sum of social support and emotional support.~      3.The best stepwise regression models of predicting major depressive disorder patients’~     quality of life were as followed：~        1. Physical domain：the best predicting factor is the degree of depression, and accounted~          for explained 60.30﹪of the variance.~        2. Psychological domain：the best predicting factors are the degree of depression, the sum~          of social support, the age of early-onset, age more than 71 years old, and accounted for~          explained 76.50﹪of the variance.~        3. Social domain：the best predicting factors are the degree of depression, the age of~          early-onset, informational and appraisal support, unemployment and age more than 71~          years old, and accounted for explained 53.80﹪of the variance.~        4. Environmental domain：the best predicting factors are the degree of depression, income~          less than one hundred thousand, income more than one hundred ten thousand and more than~          71 years old, and accounted for explained 53.50﹪of the variance.~      The results of this study could understand major depressive disorder patients’ quality of~     life condition and provide related research in the future, develop local data and health~     administration reference of foundation.~   "
258042|NCT00172536|"~     The purpose of this study is to investigate the changes of cardiorespiratory fitness and left~     ventricular function in type 2 diabetes after uncomplicated coronary artery bypass graft~     (CABG) surgery.~      We hypothesize that exercise capacity, left ventricular diastolic function, and biochemical~     data improves after 12-wk exercise training in patients with type 2 diabetes underwent CABG.~   "
258043|NCT00172523|"~     The purpose of this study is to elucidate the significance of adipocytokine in women with~     PCOS among adiposity, hyperandrogenism and insulin resistance.~   "
258044|NCT00172510|"~     To elucidate the molecular pathology of the 4 families with 17α-hydroxylase/17,20-lyase~     deficiency.~   "
258045|NCT00172497|"~     The purpose of this series of study has a many-fold intention depicted as follows: to~     describe and characterize schizophrenic patients' aggressive acts in hospital and community,~     to identify and specify heterogeneity in their structure, and to look for and set up risk~     factors for prevention. This study investigates four major issues: (1) Establishing an~     objective behavior rating scale for measuring aggressive acts; (2) Understanding the~     characteristics and incidence of aggressive acts by patients with schizophrenia; (3)~     Exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia;~     and (4) Identifying the risk factors of aggressive acts of patients with schizophrenia.~   "
258046|NCT00172484|"~     The Northern Taiwan Stroke Center for Prevention and Treatment Project is a single medical~     center, 3-year, multipurpose study. The aims of this study are (1) to set up a~     multidisciplinary stroke team in a well-designed stroke center for stroke care; (2) to~     establish a systemic stroke prevention / education protocol based on people's awareness of~     stroke; and (3) to create a better stroke rehabilitation protocol and pathway.there are three~     components in rehabilitation projects. First, we want to identify potential factors related~     to functional outcome in patients with stroke before and after stroke center. Second, we want~     to compare the functional outcome in patients who admit to the stroke center as to those~     admitted to the general ward. Third, we want to investigate the effect of electrical~     stimulation on upper limb function in patient with acute stroke.~   "
258047|NCT00172471|"~     Sleep disorders are common in patients with end-stage renal disease on both hemodialysis and~     peritoneal dialysis and are associated with significant medical, psychological and social~     disturbances. Numerous factors have been suggested as contributing to or associated with the~     high prevalence of sleep disturbance in this population.~      Increasing evidence suggests that cytokines are involved in the regulation of sleep and~     wakefulness and that the communication between the sleep and the immune system is~     bi-directional. Blood-dialyzer or peritoneum-dialysate interaction during dialysis therapy~     has the potential to activate mononuclear cells leading to production of inflammatory~     cytokines. These cytokines are believed to play a significant role in dialysis-associated~     morbidity and mortality. Nevertheless, a cytokine overproduction may alter sleep pattern in~     chronic dialyzed patients, thus explaining the presence of sleep disorders in these patients.~     In the other way, sleep loss may have effects on immune process and secretion of cytokines in~     chronic dialyzed patients. The purpose of this study was to examine the relationship between~     quality of sleep and serum cytokine levels in hemodialysis and peritoneal dialysis patients.~   "
258100|NCT00171782|"~     A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2~     hypertension and cardiovascular risk factors.~   "
258101|NCT00171769|"~     This trial is designed to provide data about feasibility and safety of short-term treatment~     with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular~     atrial fibrillation~   "
258102|NCT00171756|"~     A study to compare the effects of Diovan or Atenolol taken for 12 weeks on platelet function~     of patients who have mild to moderately severe hypertension~   "
258048|NCT00172458|"~     Vertebral artery stenosis (VAS) decreases posterior brain perfusion, causing vertebrobasilar~     insufficiency (VBI). It is also an important embolic source to the posterior brain. The most~     frequently involved location is the proximal part of the vessel, including the ostium.~     Various surgical procedures have been described for the treatment of proximal VAS with~     symptoms refractory to medical therapy, but all are technically difficult with high operative~     mortality and morbidity.~      Endovascular intervention has been described as an alternative to surgery. Balloon~     angioplasty is limited by elastic recoil and dissection. The restenosis rates reported in the~     literature varied, as high as 75 %. Stenting offers salvage following unsuccessful balloon~     angioplasty, and primary stenting have been shown to be safe and effective with lower~     restenosis rate. Coronary equipments are ideal for ostial VAS, considering the size of the~     artery and location of the lesion. Recently, Albuquerque et al. reports a relative high~     restenosis rate in a longer follow-up duration. Restenosis seems to become an important issue~     regarding the patients’ quality of life. However, there is no clinical parameter to predict~     restenosis of VAS. The purpose of this study is to evaluate the clinical results of our~     series of symptomatic ostial VAS treated exclusively with tubular balloon expandable coronary~     stents. We sought to identify predictors of restenosis.~      This is a clinical observation study. Only chart review and angiographic review will be~     performed.~   "
258049|NCT00172445|"~     Kikuchi-Fujimoto disease is a distinctive syndrome of necrotizing lymphadenitis which was~     formally described in 1972 by two Japanese pathologists, Kikuchi and Fujimoto. It is a~     benign, self-limited disease that predominantly occurs in young women. It was more common in~     Asian people, especially in Japanese. The most frequent clinical presentations are fever~     (30~50%) and cervical lymphadenopathy, often tender in palpable. Other lymph node regions can~     be affected, and hepatosplenomegaly may be present. The laboratory findings include~     leucopenia with atypical lymphocytosis. ESR, transaminases and lactate dehydrogenase are~     often raised. The clinical features are easily confused with other conditions, particularly~     lymphoma. Therefore the diagnosis depends on the pathological findings. The typical findings~     are paracortical lesions consisting of patchy zones of eosinophilic fibrinoid necrosis and~     abundant karyorrhexis. In general, spontaneous resolution of symptoms and signs within a few~     months can be expected without treatment.For decades, the etiology of Kikuchi's disease has~     been speculated. Although the perforin and Fas pathways of cytotoxic T cells induce an~     abundance of apoptosis and thus induce necrotizing lesions, the trigger factor is unknown.~     Since the disease can precede or occur in association with a connective tissue disorder,~     especially SLE, the autoimmune contribution to the etiology has also been speculated.~     However, the clinical course of Kikuchi's disease, often sudden onset and spontaneous~     resolution, the frequent flu-like or upper respiratory prodrome, and the prominence of~     cervical lymphadenopathy, support a viral cause. Evidence for a viral cause also includes~     peripheral blood atypical lymphocytosis and elevated serum IFN-a or 2`-5` oligoadenylate~     synthetase levels. Several infectious agents have been suggested, including bacteria (e.g.~     Brucella, Yersinia), parasites (e.g. toxoplasmosis) and viruses (e.g. EBV, CMV, HHV6, HHV8,~     parvovirus B19, HTLV, HIV).The aim of this study is to collect cases of Kikuchi' disease in~     bureau of NHI and NTUH. We will analyze the incidence rate, age of onset, sex, season of~     onset and clinical course to see if there is any clustered cases, or nosocomial infection.~     Then we will study the etiology of Kikuchi's disease especially the infection causes by~     analyzing pathologic specimen and serology. We hope to find out the etiology of Kikuchi's~     disease and the new treatment.~   "
258050|NCT00172432|"~     Background: Myocardial fibrosis is a major component in cardiac remodeling in patients with~     myocardial infarction or hibernation. However, the association of cardiac fibrosis and~     coronary artery disease (CAD) in patients without infarction or hibernation is still unclear.~     In the present study, we analyzed the relationship between serum concentrations of~     procollagen propeptides and severity of CAD in such patients. Patients and methods: Forty-six~     patients (32 men and 14 woman; mean age 64 years) with chest pain and normal left ventricular~     contractility were enrolled into this study. Myocardial infarction was excluded by history~     and electrocardiograms. All patients received stress thallium-201 single photon emission~     computed tomography (SPECT) and analysis of the serum levels of the aminoterminal propeptide~     of type I and III procollagen (PINP and PIIINP).~   "
258051|NCT00172419|"~     Inflammation is important in the both pathogenesis and outcome of atherosclerosis. Plaques~     containing numerous inflammatory cells, particular macrophages, have a high risk of~     rupture.We hypothesize that statin-induced plaque regression could be monitored clinically by~     use of FDG PET/CT approach, and can be detected noninvasively earlier than previously~     reported.~   "
258052|NCT00172406|"~     In the present study, we assessed the relation between diastolic dysfunction and myocardial~     fibrosis in hypertensive patients without diabetes mellitus. A total of 20 medically treated~     ambulatory non-diabetic hypertensive patients with normal left ventricular (LV) systolic~     function were enrolled into this study. Myocardial fibrosis was evaluated by serum~     concentrations of amino-terminal propeptides of type I and III procollagen (PINP and PIIINP).~     All patients underwent examinations of diastolic function by echocardiography and~     technetium-99m (99mTc) radionuclide ventriculography. There were 8 patients with PINP ≦53~     μg/l (group 1) and 12 patients with PINP >53 μg/l (group 2). Patients in group 2 had~     significantly lower LV peak filling rate (PFR; 3.2 ± 0.3 vs. 2.5 ± 0.2 end-diastolic~     volume/s) and shorter time to PFR ( 257 ± 41 vs. 174 ± 22 ms). Besides, the group 2 patients~     also had lower right ventricle PFR (1.9 ± 0.2 vs. 1.5 ± 0.1 end-diastolic volume/s) and~     shorter time to PFR ( 221 ± 29 vs. 154 ± 29 ms). Echocardiographic parameters for LV~     diastolic dysfunction (E/A ratio of mitral flow, deceleration time of E flow, velocities of~     pulmonary venous flow [retrograde A wave, systolic /diastolic velocity ratio], isovolumetric~     relaxation time, Tei index) were all comparable between two groups. In multiple regression~     analysis, LV time to peak filling rate was the only parameter that independently predicted~     serum PINP level (p<0.05). In conclusion, elevated serum PINP level reflected LV diastolic~     dysfunction in hypertensive patients without diabetes.~   "
258053|NCT00172393|"~     Our study involved 142 children with EV71 CNS infections that included 61 (43%) with viral~     meningitis, 53 (37%) with severe CNS involvement including encephalitis, polio-like syndrome~     and encephalomyelitis, and 28 (20%) with cardiopulmonary failure after CNS involvement. These~     children were subjected to physical and neurological examinations 2.85 (range 1.0-7.39) years~     after disease onset. Those below the age of 6 years took the Denver developmental screening~     test, while those 4 years and over took the intelligence quotient (IQ) test.~   "
258054|NCT00172380|"~     To assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior~     to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa~     and IIIb.~   "
258055|NCT00172367|"~     Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells~     in patients with uremia-associated urothelial carcinoma.~      Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg~     per day for 12 weeks in uremic patients.~   "
258056|NCT00172354|"~     Out-of-hospital cardiac arrest (OHCA) is an important issue for the emergency physicians and~     co-workers. How to improve the return of spontaneous circulation (ROSC) rate and prognosis of~     these patients challenges the emergency team. When encounters stress, the hypothalamus of~     human releases corticotropin releasing hormone, which in turn stimulates the pituitary gland~     to release ACTH. Then ACTH acts on the adrenal gland to release glucocorticoid to against~     stress. Foley PJ et al found the dogs with bilateral adrenalectomy had lower ROSC rate during~     resuscitation than those without surgery[1]. Karl H. Linder et al showed OHCA patients had~     high serum vasopressin and ACTH level but low serum cortisol level. Besides, the serum~     cortisol level had a negative correlation with collapse duration (no CPR duration)[2].~     Studies also revealed the successfully resuscitated patients had higher serum ACTH and~     cortisol level than non-resuscitated ones[2,3]. In addition, the serum cortisol level was~     found to be correlated with short term survival rate and hemodynamic status in resuscitated~     OHCA patients[3]. Animal study also showed mice receiving higher dosage of hydrocortisone had~     higher ROSC rate and lower epinephrine requirement than those receiving lower dosage of~     hydrocortisone or normal saline.~      <Reference>~        1. Foley PJ, Tacker WA, Wortsman J, Frank S, Cryer PE.; Plasma catecholamine and serum~          cortisol responses to experimental cardiac arrest in dogs.Am J Physiol 1987;253:E283-9~        2. Lindner KH, Strohmenger HU, Ensinger H, Hetzel WD, Ahnefeld FW, Georgieff M.; Stress~          hormone response during and after cardiopulmonary resuscitation.Anesthesiology~          1992;77:662-8~        3. Schultz CH, Rivers EP, Feldkamp CS, Goad EG, Smithline HA, Martin GB, Fath JJ, Wortsman~          J, Nowak RM.;A characterization of hypothalamic-pituitary-adrenal axis function during~          and after human cardiac arrest.Crit Care Med 1993;21:1339-47~        4. Smithline H, Rivers E, Appleton T, Nowak R.;Corticosteroid supplementation during~          cardiac arrest in rats.Resuscitation 1993;25:257-64~   "
258057|NCT00172341|"~     Asthma, the airway inflammatory disorder, is an important chronic disease in children. About~     10~15% children are bothered with this. Allergens, such as house-dust mites (HDM), animal~     dander (i.e. cats and dogs), and seasonal pollens, are often implicated as causative and~     triggering factors of respiratory attacks in children with asthma. Among them, mites are the~     most common indoor allergen associated with asthma worldwide.~      It appears that SLIT is somewhat effective and safe. However, on the current evidence,~     further studies are needed to define the indications, the duration of treatment and~     therapeutic optimal dose of standardized allergen extracts in relation to efficacy and side~     effects before it is recommended for routine clinical use. The objective of the present study~     was to investigate the effects and safety of StaloralTM, the standardized extracts of D. pt.~     and D. f., in asthmatic children allergic to HDM.~   "
258058|NCT00172328|"~     Taiwan is an endemic region for hepatitis B. Before the implementation of a nationwide~     vaccination program in 1984, the hepatitis B virus (HBV) carrier rate in the general~     population was 15 to 20%.1-2 The major impact of hepatitis B (HB) infection is its long-term~     sequelae which may include chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma.3~     Perinatal infection accounts for 40-50% of all hepatitis B infections and is responsible for~     the generation-to-generation transmission of HB virus.4 Hepatitis B vaccines, both plasma~     derived and recombinant, are highly immunogenic and efficacious.5-10 It has been reported~     that HB vaccine given soon after birth is able to protect infants from perinatal infection~     and HB infection became the first disease model to show that mother-to-neonate transmission~     can be interrupted by an effective vaccine.11 Taiwan started a national program of HB~     vaccination since 1984. This program resulted in a significant reduction of the HB carrier~     rate in children aged below 10 years from 9.8% before nationwide vaccination to 1.3% after~     the program.12 It also decreased the incidence of hepatocellular carcinoma in children aged 6~     to 9 years from 0.52 to 0.13 per 100,000.13 However, the duration of protection provided by~     the HB vaccine and the proper timing of a booster dose remains unclear. Because the HB~     vaccine is a subunit protein vaccine, which contains only HBsAg, a limited duration of~     protection is anticipated. The results of several long-term follow-up studies of the~     protective efficacy of HB vaccination have been published. Soon after vaccination, protective~     levels of antibody (anti-HBs >10 mIU/mL) can be detected in the great majority (83-99%) of~     vaccinees.5-7 The proportion of vaccinees with protective anti-HBs levels decreases to 75-87%~     5 years after vaccination and further drops to 50 to 70% 10-12 years after.10,11,14,15,19-21~     Because of the progressive decline of anti-HBs and the associated increased likelihood of~     development of new HBV infections, some investigators advise the use of a booster~     vaccination.20,21 However, a preponderance of data indicates that the protective efficacy of~     the HB vaccine can last for at least 5 to 10 years and a booster before 5 years is not~     necessary.16-18,22,23 By demonstrating significant augmentation of cellular immunity and~     adequate induction of a protective level of antiHBs (>10 mIU/ml) in HBsAg and HBeAg-positive~     subjects 10 years after HB vaccination, we also proved that protection afforded by HB~     vaccination persisted for no less than 10 years in all vaccinees.R Nevertheless, the~     protective efficacy after the period of 10 years remains unknown. Knowledge of the duration~     of protection of HB vaccine and the optimal timing of booster vaccination remains crucial. In~     this study, we are going to examine the humoral and cellular immunity and monitored the~     antibody response following a booster dose of HB vaccine in a group of children whom had been~     vaccinated 14 years prior to this study.~   "
258059|NCT00172315|"~     Magnetic resonance spectroscopy (MRS) is commonly applied in medicine with 1H proton or~     31-phosphorus spectra. The proton MRS is often used in evaluating the central nervous system~     and 31P MRS is used in muscular diseases or neoplasms. However, the proton MRS is also~     considered to be applied to the musculoskeletal system because of its profound amount of~     protons. Ballon used the STEAM technique, and Schick used the PRESS technique, to investigate~     the lipid and water spectra of the bone marrow and also correlated those with hematological~     diseases and post-treatment effects. Schellinger et al. used the STEAM sequence to calculate~     the lipid content of the vertebral bone marrow and found that it was influenced according to~     age and sex. The investigator had used the proton MRS to evaluate the lipid and water spectra~     of the femoral head and revealed its significance in predicting avascular necrosis of the~     femoral head. According to the above research literature, the investigators considered~     further investigation of the proton MRS in evaluating the musculoskeletal system.~   "
258060|NCT00172302|"~     Intravenous vitamin C may improve skin hyperpigmentation in chronic hemodialysis patients~   "
258061|NCT00172289|"~     According to the theory of wave transmission, the speed of wave transmission is dependent on~     the nature of the transmission medium, which is the vessel wall for pulse wave transmission.~     Then, the pulse wave velocity is related to the mechanical property of the vessel wall. The~     mechanical property of the vessel wall is determined by the texture of the vessel wall and~     the contraction status of the smooth muscle within the vessel wall. Because the texture of~     the vessel wall could not be changed in a short duration, the sympathetic nerve activity,~     which controls the contractibility of the smooth muscle, becomes the only determinant factor~     of pulse wave velocity. So, pulse wave velocity may reflect the status of sympathetic nerve~     activity. The purpose of this project is to use the pulse wave velocity to measure the~     sympathetic activity of stroke and spinal cord patients. The present project plans to measure~     the pulse wave simultaneously at four limbs by pressure receptors, and use the~     electrocardiogram as the reference to synchronize the recorded pulse wave at different~     vessels, using the corrected data to calculate the pulse wave velocity. With the pulse wave~     velocity of different vessels, we, the investigators at National Taiwan University Hospital,~     can understand the local sympathetic nerve activity in different diseases and different~     sites.~      The first year, we will set up the equipment for measuring the pulse wave velocity, and then~     apply it to 20 healthy subjects to adjust the measurement error and ascertain the~     reproducibility of the machine. The second year, we will apply the measurement to 15 complete~     cervical cord injury individuals and 15 healthy subjects in different erected angles by a~     tilting table. This procedure will make us understand the response of sympathetic nerve~     activity to different postures in normal subjects and cervical cord injury patients. The~     third year, we will apply the measurement to 30 cerebrovascular accident patients to~     understand the change of sympathetic nerve activity after having a stroke. By comparing the~     clinical information, we hope to clear up the relationship between sympathetic nerve activity~     and pulse wave velocity.~   "
258103|NCT00171743|"~     The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine~     microemulsion benefits post-transplant diabetes management (in terms of glycogenic control~     and insulin dosage) in stable liver transplant recipients.~   "
258104|NCT00171730|"~     Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth~     hormone (GH), generally caused by a GH-secreting pituitary adenoma. This study will assess~     the long-term safety and efficacy of pasireotide in patients with acromegaly.~   "
258949|NCT00160498|"~     A double blind study to examine the safety and efficacy of different dosages of lercanidipine~     in normal weight and obese patients with hypertension~   "
258063|NCT00172263|"~     Severe acute respiratory syndrome (SARS) is a new threat to public health since November,~     2002. The SARS is highly contagious and is believed to be transmitted by person-to-person~     through droplet and direct contact. The patients present with fever, chills, cough, myalgia,~     dyspnea, and diarrhea. The symptoms aggravate in the second week and nearly 40% of the~     patients develop respiratory failure that requires assisted ventilation. The mortality rate~     is reported as 6.5%-7%.~      After several months, the world scientists found the etiology to be a new coronavirus not~     belonging to the previous coronavirus group I, II and III. The new virus is called SARS~     associated coronavirus (SARS-CoV).~      Although the high morbidity and mortality of SARS occurred in adults, there was rare~     mortality reported in the children. The report from Hong Kong pointed out that the symptoms~     of SARS in younger children were milder and the clinical course was not as aggressive as in~     adults. Therefore, the aim of the project is to design the experiment to see the differences~     of immunological responses to SARS-CoV protein in healthy younger children, teenagers, and~     adults. The investigators hope that the result could explain the reason for milder disease in~     younger children and the immunological pathogenesis of SARS.~   "
258064|NCT00172250|"~     Elevation of plasma homocysteine has been recognized as one of the risk factors of~     atherosclerotic disease. The objectives of this study are: (1) to investigate the level of~     plasma homocysteine and the prevalence of hypehomocysteinemia (2) to find out the role of~     homocysteine in coronary artery disease and the proper cut-off point of plasma homocysteine~     to evaluate the presence of coronary artery disease; (3) to understand the control condition~     of tranditional risk factors of cardiovascular disease, especially hypertension,~     dyslipidemia, and diabetes mellitus.~      The study subjects were recruited from the ambulatory setting of cardiology in National~     Taiwan University Hospital.~   "
258065|NCT00172237|"~     Specific aims of this project were as follows:~        1. To investigate the eye-head coordination of patients with cervical spine degeneration.~        2. To investigate the relationship of these impairment measurements (range of motion,~          muscle power, proprioception, sensory threshold, eye-head coordination) and functional~          outcome (neck disability index, quality of life evaluation).~        3. To develop a computer assistant device and software for the proprioceptive training and~          eye-head coordination.~        4. To provide a treatment and prevention program emphasized on proprioception treatment and~          coordination for employee with neck-shoulder complaints.~   "
258066|NCT00172224|"~     The etiology and pathogenesis of osteoporosis has been extensively discussed. The~     relationship between bone blood circulation and the formation of bony trabeculae has been~     less understood. There is plenty of indirect evidence highly suggestive of the correlation~     between these two factors, such as: the number of blood vessels in the per unit area of the~     bone marrow was decreased in the osteoporotic bone, indicating the possible role of a~     microvascular defect in the pathogenesis of osteoporosis.~      Furthermore, the bone mineral density in severe arteriosclerotic patients was lower than in~     the less affected subjects. In a large scale epidemiologic study, diminished bone mineral~     density was strongly associated with increased deaths from stroke. Osteopenia was also~     associated with an increased risk of stroke. These reports highly suggest the effect of~     ischemia on bone metabolism and make the investigators more interested in further~     investigation.~      A dynamic contrast-enhanced magnetic resonance (MR) study was used recently in evaluating the~     blood perfusion of bone tumors. This method also has a strong correlation with the~     microsphere blood flow measurements. The investigator (T.F. Shih) used the dynamic MR in her~     recent two researches:~        1. To differentiate benign versus malignant spinal compression fractures.~        2. To evaluate the blood perfusion of non-fractured, normal-appearing vertebral bodies and~          find its significant correlation with aging and sex.~      The alterations of bone marrow perfusion are synchronous with the changes of bone mineral~     density. Thus, based on the investigators' previous research work, they propose to further~     explore the relationship between bone marrow perfusion and bone mineral density in different~     age groups.~   "
258067|NCT00172211|"~     Patients affected by end-stage renal disease (ESRD) are subjected to enhanced oxidative~     stress, as a result of reduced anti-oxidant systems and increased pro-oxidant activity.~     Besides, insulin resistance is also very common in ESRD patients. Both enhanced oxidative~     stress and insulin resistance increase the risk of atherosclerosis and cardiovascular~     mortality, and intention to reduce oxidative stress and insulin resistance is important in~     ESRD patients who suffer from high cardiovascular risk.~      The high concentration of glucose and glucose degradation products (GDP), high lactate, and~     low pH in conventional peritoneal dialysis (PD) solutions are known as bioincompatible~     factors, which are believed to increase oxidative stress in PD patients. Physioneal®, a more~     biocompatible dialysis solution with neutral pH, physiologic bicarbonate concentration and~     low GDP level, has been applied in Europe for several years. Previous studies of Physioneal®~     have revealed advantages of improved infusion pain, more efficient acid-base control,~     increased ultrafiltration, and reduced peritonitis duration. However, its effects on~     oxidative stress and insulin resistance in peritoneal dialysis patients are not reported yet.~     The comparison of oxidative stress and insulin resistance before and after using Physioneal®~     may help to elucidate the possibly beneficial effects on uremic patients, which frequently~     suffer from increased oxidative stress and insulin resistance.~      Thirty continuous ambulatory peritoneal dialysis (CAPD) patients will be selected in this~     study, and receive conventional solution (Dianeal® PD-2 or PD-4) for a baseline period of 3~     months. Then Physioneal® will be used for 3 months. Clinical conditions, biochemical and~     hematological parameters, oxidative markers in blood and effluent, and insulin resistance~     will be measured at baseline, before and after Physioneal®, and some markers will be measured~     1 month after discontinuing Physioneal® and changing back to conventional solution. The~     medication used in each patient will be recorded, and the dialysis prescription will be~     adjusted by a nephrologist according to clinical data. The data collected before and after~     Physioneal® will be analyzed by paired-t test.~   "
258068|NCT00172198|"~     1. A prospective, controlled, randomized, study evaluating the clinical efficacy, including~          nutritional status, immune function and safety of Omegaven (ω-3 fish oil) supplemented~          parenteral nutrition in subjects of SICU.~        2. Study patients are the critical ill patients in SICU of NTUH and the enrolled patients~          will be 30 subjects ,including 15 in each treatment group.~        3. During parenteral nutrition, fat emulsions will be given separately from amino acid and~          glucose solutions. Infusion pump must be used.The recommended infusion duration of the~          daily lipid emulsion is 16 hours (0.0625 g fat/kg B.W./hour) from 8:00 am to 12:00 pm.~        4. During the study the assessments of safety and efficacy are to be performed according to~          case report form. The assessment for safety variables including blood pressure、heat rate~          、body temperature、liver function、renal function、coagulation、WBC、lipid profile etc. In~          addition，the assessments for efficacy variables including~          lymphocytes、cytokines(IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40~          ligand、G-CSF、FN-γ、TGF-β1、TNF-α etc)、incidence of infections、 length of ICU and hospital~          stay、mortality etc.~   "
258069|NCT00172185|"~     The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily~     administration of teduglutide.~   "
258071|NCT00172159|"~     More and more colorectal surgeons believe that surgical resections of hepatic metastases from~     colorectal cancer is the only chance for cure of patients. The five-year survival for~     patients with hepatic metastasis from colorectal cancer after surgical resection is~     approximately 30 %. However, most hepatic metastases from colorectal cancer were inoperable.~     With the progress of chemotherapy, for example, the combination of the 5-Fu, leucovorin, and~     oxaliplatin, some surgeons advocated that approximately 20% of inoperable liver metastases~     will be converted to operable case, thus providing the long-term survival for patients. In~     this study, we made a phase Ⅱ clinical trial regarding the use of the Folfox-4 regimens in~     the neo-adjuvant treatment of inoperable hepatic metastases. Our aims is to evaluate the~     tumor response rate for this regimen, the rate of resectability of liver metastases,~     progression free survival and overall survival of patients. In addition, the difference~     between the reports from Western and Oriental countries will be analyzed. We believe this~     study will provide new perspectives regarding the most beneficial treatment modalities for~     the patients with hepatic metastases from colorectal cancer.~   "
258072|NCT00172146|"~     The purpose of this study was to examine the influence of cane use on the movement, kinetics,~     and associated attentional demands of performing a voluntary forward stepping movement in~     patients with stroke and age-matched healthy adults.~   "
258073|NCT00172133|"~     This is an Open Label Extension Study (OLES) for patients who participated in the 18 month~     double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study)~     studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on~     vertebral fracture incidence. The primary objective of this study is to evaluate the safety~     of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal~     osteoporotic women who participated in Protocol ALX1 11 93001.~   "
258074|NCT00172120|"~     TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy~     variables assessed in the OLE study for a maximum treatment duration of 36 months in OLES and~     TRES combined.~   "
258075|NCT00172107|"~     A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of~     3 doses of ALX1-11 (recombinant human parathyroid hormone [rhPTH(1-84)])(50, 75 and 100 µg)~     in the treatment of postmenopausal osteoporosis. The primary objective of this study is to~     compare the efficacy of ALX1-11 (50, 75 and 100 µg) with that of placebo in terms of~     increasing vertebral bone mineral density, when given daily by subcutaneous injection for 12~     months in postmenopausal women with osteoporosis.~   "
258076|NCT00172094|"~     The purpose of this study was to evaluate the effectiveness and safety of a single oral dose~     of NPS 1776 in the acute treatment of migraine pain and associated symptoms.~   "
258077|NCT00172081|"~     This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month~     interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84)~     (rhPTH [1-84]), on fracture incidence in women with postmenopausal osteoporosis, the TOP~     study.~   "
258078|NCT00172068|"~     Metastatic bone disease is an important prognostic factor for survival which will in median~     be close to two years after first diagnosis of osseous metastases. This open-label study will~     investigate the safety and efficacy of zoledronic acid in patients with breast cancer and~     minimal residual disease in the bone marrow.~   "
258079|NCT00172055|"~     The objective of the study is to investigate whether blood markers can be used to predict the~     development of bone metastases and to assess the efficacy and safety of zoledronic acid in~     cancer treatment induced bone loss.~   "
258080|NCT00172042|"~     30-40% of patients with lung cancer will develop bone metastases during the course of their~     disease, which can lead to pain, decreased mobility and skeletal complications. This study~     will investigate the effect of zoledronic acid on preventing or delaying the development of~     bone metastases and the impact on disease progression/survival in patients with stage IIIA~     and IIIB Non-small Cell Lung Cancer (NSCLC).~   "
258081|NCT00172029|"~     The aim of this prospective, randomized, open-label, multicentric clinical study is to assess~     the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4~     weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy~     in patients with breast cancer and metastatic bone disease associated with pain.~   "
258082|NCT00172016|"~     The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in~     preventing skeletal-related events in patients with prostate cancer~   "
258083|NCT00172003|"~     It is the aim of this clinical study to evaluate the skeletal-related event rate under~     therapy with zoledronic acid in patients with renal cell cancer having at least one~     cancer-related bone lesion.~   "
258084|NCT00171990|"~     This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare~     the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed~     by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in~     patients with active recurrent genital herpes.~      This study is not recruiting patients in the United States.~   "
258085|NCT00171977|"~     This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of~     postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative~     resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as~     measured by the confirmation of tumor recurrence and survival for 3 years after surgery for~     their primary tumors.~   "
258086|NCT00171964|"~     It is the aim of this multicentric clinical study to assess the efficacy and tolerability of~     zoledronic acid in combination with radiotherapy in patients with advanced osteolytic bone~     lesions in terms of the reduction of pain and analgesic consumption.~   "
258087|NCT00171951|"~     Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic~     hormone (ACTH) secreting pituitary adenoma. This study will assess the long-term safety and~     efficacy of pasireotide in patients with Cushing's disease.~   "
258088|NCT00171938|"~     This is an open label clinical trial of imatinib mesylate 800 mg po/day in a population of~     patients with unresectable, recurrent glioblastoma multiforme. Patients will be treated for~     up to 12 months~   "
258089|NCT00171925|"~     Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant~     plasma cells induce osteolytic lesions, which is characteristic for progression of multiple~     myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence~     on the progression of multiple myeloma.~   "
258105|NCT00171717|"~     The trial is conducted in patients who have received a liver transplant, were prescribed~     tacrolimus to prevent organ rejection and developed diabetes from 3 month~     post-transplantation onwards. The goal of the trial is to assess the percentage of patients~     in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine~     micro-emulsion as measured by a fasting blood glucose < 1,26 g/l without the need of~     hypoglycemic treatment.~   "
258106|NCT00171704|"~     Estrogen is known to be a regulator of bone and lipid metabolism. Letrozole is a potent~     inhibitor of estrogen synthesis.~      This study evaluated the effects of letrozole and tamoxifen on bone and lipid metabolism in~     postmenopausal women with resected, receptor positive early breast cancer.~   "
258107|NCT00171691|"~     This study will test the efficacy and safety of topical Voltaren in the treatment of knee~     osteoarthritis.~   "
258108|NCT00171678|"~     This study will test the efficacy and safety of topical diclofenac sodium gel in the~     treatment of knee osteoarthritis.~   "
258109|NCT00171665|"~     This study will test the efficacy and safety of topical diclofenac sodium gel in the~     treatment of hand osteoarthritis.~   "
258110|NCT00171652|"~     This study will test the efficacy and safety of topical diclofenac sodium gel in the~     treatment of hand osteoarthritis.~   "
258111|NCT00171639|"~     This study is being conducted to evaluate the effect of an investigational drug on bone loss~     in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT).~      In order to participate, male patients 18 years and older must be veterans from participating~     Veterans Administration Medical Centers that are receiving ADT for prostate cancer and have~     established osteoporosis.~   "
258112|NCT00171626|"~     This study will test the efficacy and safety of topical diclofenac sodium gel in the~     treatment of knee osteoarthritis.~   "
258113|NCT00171613|"~     The extension protocol is designed to allow those patients randomized to placebo in the core~     portion of the protocol to receive a 6 month treatment of open label octreotide and allow~     those patients randomized to octreotide who appeared to benefit from treatment, to continue~     to receive octreotide.~   "
258114|NCT00171600|"~     Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in~     non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20~     weeks follow-up.~      Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs~     combo treatment in non-diabetic and diabetic patients.~      Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more~     than monotherapies..~      Design: Multicentric, randomized, open label, parallel group, active controlled.~      Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20~      Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus~     lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up.~     Description % of change in albuminuria from baseline at 20 weeks.~      Secondary Endpoint : To investigate the effect of 5 months treatment with~     valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to~     investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus~     lisinopril on blood pressure and the effect on left ventricular mass index using~     electrocardiogram and Cornell-Sokolow method.~   "
258115|NCT00171587|"~     The objective of this study is to assess the safety, tolerability, dose limiting toxicity,~     and maximum tolerated dose of vatalanib administered orally once daily in combination with~     capecitabine in patients with advanced cancer. The study is also designed to determine the~     effect of vatalanib on the pharmacokinetics of capecitabine and the effect of capecitabine on~     the pharmacokinetics of vatalanib, and to describe the anti-tumor activity of this~     combination regimen.~   "
258116|NCT00171574|"~     Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in~     non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group,~     controlled trial, 5 months follow-up.~      Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo~     treatment in no-diabetic and diabetic patients.~      Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin~     ratio more than monotherapies.~      Design: Multicentric, randomized, double blind, parallel group, active controlled.~      Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20~   "
258117|NCT00171561|"~     The purpose of this study is assess if treatment with valsartan and a diuretic,~     hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and~     albuminuria (protein in the urine) compared with amlodipine. In particular, the study will~     assess whether the treatment will decrease the stiffness of the blood vessels.~   "
258118|NCT00171548|"~     Metabolic syndrome is commonly defined as a set of risk factors and abnormalities that~     markedly increase the risk of cardiovascular events. Its relevance has been confirmed by a~     recent population-based survey of subjects aged 40-79 years indicating that the prevalence of~     metabolic syndrome in Italy is 34.1% if diagnosed using WHO criteria and 17.8% if diagnosed~     using the NCEP-ATPIII criteria.~      On the basis of the above considerations, the aim of this study is to promote the use of the~     SCORE algorithm for estimating cardiovascular risk, and to evaluate its evolution in patients~     with metabolic syndrome after the implementation of a multifactorial preventive strategy,~     with particular reference to the correction of lifestyle, hypertension and dyslipidemia.~   "
258119|NCT00171535|"~     This study will assess the effectiveness and safety of different combination antihypertensive~     treatments in patients with severe hypertension~   "
258120|NCT00171522|"~     To determine whether female patients have a preference for tegaserod of PEG 3350 relative to~     dosage form, convenience, ease of administration and taste~   "
258121|NCT00171509|"~     The purpose of this study is to determine whether cyclosporine microemulsion given once a day~     instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose~     control in stable liver transplant recipients. The study also aims to identify the target~     ranges of levels of cyclosporine microemulsion in the blood.~   "
258122|NCT00171496|"~     The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine~     microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and~     safety in preventing organ rejection~   "
258123|NCT00171483|"~     Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn~     and regurgitation in patients with incomplete relief from PPIs .~   "
258128|NCT00171418|"~     Study to assess the effects of adding tegaserod to PPI therapy results in clinically~     meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on~     daily PPI therapy alone.~   "
258129|NCT00171405|"~     The purpose of this study is to collect the long-term (12 months) safety data on aliskiren~     300 mg when taken in combination with HCTZ 25 mg.~   "
258130|NCT00171392|"~     The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate~     sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to~     enteric-coated mycophenolate sodium in stable renal transplant patients.~   "
258131|NCT00171379|"~     The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF~     to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.~   "
258132|NCT00171366|"~     Comparison of the safety and efficacy of the combination of amlodipine/Benazepril to~     amlodipine monotherapy in patients with non-essential hypertension, not controlled on~     amlodipine alone.~   "
258133|NCT00171353|"~     One hundred twenty patients with arterial hypertension and albuminuria (some amount of~     albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure.~     Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.~   "
258134|NCT00171340|"~     Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment~     of breast cancer and will be randomized to a treatment group to receive either upfront~     zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4~     mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when~     either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar~     spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture~     discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.~   "
258135|NCT00171327|"~     Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and~     decreased vascular dilatation, receiving a cholesterol lowering diet were given either~     valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination~     treatment with valsartan 160 mg and fluvastatin 80 mg.~   "
258136|NCT00171314|"~     Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment~     of breast cancer and will be randomized to a treatment group to receive either upfront~     zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4~     mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when~     either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar~     spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture~     discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.~   "
258137|NCT00171301|"~     To allow patients treated with deferasirox in the core study to continue iron chelation~     therapy for 2 years or until the drug became locally commercially available. To evaluate the~     long-term safety and efficacy of deferasirox by measuring treatment success, change in liver~     iron content (LIC) and change in serum ferritin levels. Safety was mainly assessed by~     incidence of adverse events (AEs)and clinically significant lab parameters.~   "
258138|NCT00171288|"~     The objective of this study is to assess the effect of the combination treatment on~     C-reactive protein and inflammatory markers as well as the safety and tolerability in a~     Spanish population~   "
258139|NCT00171275|"~     This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed~     shortly after or immediately when the coronary event occurs.~   "
258140|NCT00171262|"~     To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing~     certain inflammatory markers. In addition, tolerability and safety will also be evaluated in~     a Spanish population.~   "
258141|NCT00171249|"~     This extension II study will allow for further follow-up of the disease under treatment with~     imatinib mesylate and allow the patients to continue to receive imatinib mesylate.~   "
258142|NCT00171236|"~     The purpose of the study is to assess the safety and efficacy of fluvastatin in children~     diagnosed with heterozygous familial hypercholesterolemia~   "
258143|NCT00171223|"~     This extension study will allow for further follow-up of the disease under treatment with~     imatinib mesylate and allow patients to continue to receive imatinib mesylate.~   "
258144|NCT00171210|"~     A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator~     was conducted to investigate the efficacy of deferasirox in regularly transfused patients~     with β-thalassemia 2 years of age and older. Patients who successfully completed this main~     trial may continue in this extension trial to receive chelation therapy with deferasirox for~     an additional 4 years.~      The objective of this study is to assess the efficacy and long-term safety of deferasirox in~     regularly transfused patients with β-thalassemia 2 years of age and older.~   "
258145|NCT00171184|"~     The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks~     treatment with darifenacin in patients aged >Ý 65 years with OAB.~   "
258146|NCT00171171|"~     Because patients with beta-thalassemia are unable to actively eliminate iron from the body,~     toxic and eventually lethal levels of iron can accumulate as a result of repeated blood~     transfusions. This study will evaluate the efficacy, safety and tolerability of deferasirox.~   "
258147|NCT00171158|"~     This extension II study will allow for further follow-up of the disease under treatment with~     imatinib mesylate and allow the patients to continue to receive imatinib mesylate.~   "
258148|NCT00171145|"~     This study will assess the efficacy of a 12-week treatment with darifenacin in increasing~     warning time, the time from first sensation of urgency to voiding, in patients with OAB.~   "
258149|NCT00171132|"~     The purpose of the study is to show that valsartan compared to atenolol has favorable effects~     on exercise capacity, quality of life, diastolic function and elevated blood pressure in~     hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal~     left ventricular ejection fraction (LVEF).~   "
258150|NCT00171119|"~     The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the~     combination of both in reduction of microalbuminuria in Type 2 diabetic patients.~   "
258151|NCT00171106|"~     This study will test the effects of valsartan versus placebo on exercise tolerance in~     patients with symptoms of heart failure~   "
258152|NCT00171093|"~     This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and~     80 mg simvastatin together compared to using either one alone in lowering blood pressure and~     LDL cholesterol. After discontinuing current drug therapies for hypertension and~     hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg~     valsartan+placebo, or 80mg simvastatin+placebo..~   "
258153|NCT00171080|"~     The purpose of the study is to compare the efficacy, safety and tolerability of valsartan 80~     mg (with a starting dose of 40 mg) to irbesartan 150 mg (with a starting dose of 75 mg) in~     patients on long-term haemodialysis with mild to moderate increased mean supine systolic~     blood pressure (MSSBP).~   "
258154|NCT00171067|"~     The purpose of this study is to compare if the combination of valsartan 320 mg/lisinopril 20~     mg versus the monotherapies of lisinopril 40 mg or valsartan 320 mg will result in a greater~     decrease of urinary albumin excretion measured as urinary albumin/creatinine ratio (UACR) in~     the first morning urine of hypertensive subjects with previously diagnosed microalbuminuria~     (MAU).~   "
258155|NCT00171054|"~     The purpose of this study is compare treatment with valsartan with the possible addition of a~     diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the~     possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment~     on the stiffness of the blood vessels will be studied.~   "
258156|NCT00171041|"~     Drugs used to treat high blood pressure in adults should also be effective in treating high~     blood pressure in children and adolescents. This study will test the safety and efficacy of~     valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose~     parent(s)/guardian(s) grant permission to participate.~   "
258157|NCT00171028|"~     Drugs used to treat hypertension in adults should also be effective in treating high blood~     pressure in infants and children. This study will test the safety and efficacy of valsartan~     in lowering blood pressure in children 1 - 5 years old whose parents grant permission to~     participate.~   "
258158|NCT00171015|"~     To evaluate the efficacy of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding~     to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan~     medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis that valsartan 160 mg/HCTZ 25 mg~     significantly reduces the trough mean sitting diastolic blood pressure (MSDBP) after a 4-week~     treatment in the nonresponder population.~   "
258159|NCT00171002|"~     This study will test the effectiveness and safety of a combination treatment in patients~     whose blood pressure is not controlled with a single medication~   "
258160|NCT00170989|"~     This study will test the effectiveness and safety of a combination treatment in patients~     whose blood pressure is not controlled with a single medication.~   "
258161|NCT00170976|"~     A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.~   "
258162|NCT00170963|"~     This study will test the effectiveness and safety of a combination treatment in patients~     whose blood pressure is not controlled with a single medication~   "
258163|NCT00170950|"~     A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to~     evaluate the effectiveness of the combination on reducing heart disease and death in a high~     risk hypertensive population.~   "
258164|NCT00170937|"~     The metabolic syndrome is a classification for patients with a constellation of risk factors~     which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or~     more of these factors together constitute the metabolic syndrome and place these patients at~     a greater risk for the development of diabetes and cardiovascular diseases. The purpose of~     this study is to determine whether two common drugs to lower blood pressure, whether used~     separately or in combination, have different effects on blood sugar levels in patients~     diagnosed with the metabolic syndrome.~   "
258165|NCT00170924|"~     Patients who have had high blood pressure for a long time may have diastolic dysfunction.~     Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing~     adequately.~      This study is to find out if Valsartan) will improve the ability of the heart to fill, empty,~     and relax appropriately when given alone or with other medicines to treat high blood~     pressure.~   "
258166|NCT00170911|"~     AAE581 is a specific inhibitor of the cysteine protease cathepsin K. This trial is designed~     to provide detailed information about the effects( efficacy and safety) of AAE581 on Bone~     Mineral Density.~   "
258167|NCT00170898|"~     This study is designed to develop our understanding of the risk-benefit of using lumiracoxib~     in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.~   "
258168|NCT00170885|"~     The purpose of the study in de novo renal transplant patients is to evaluate the effect on~     renal function of an optimized new regimen in comparison with the standard everolimus~     exposure plus a low-dose cyclosporine microemulsion regimen.~   "
258169|NCT00170872|"~     This study tested the safety, tolerability and efficacy of lumiracoxib - a COX-2 inhibitor-~     in patients with primary knee osteoarthritis or rheumatoid arthritis.~   "
258170|NCT00170859|"~     In this study two immunosuppressive regimens (everolimus in combination with cyclosporine~     microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose~     cyclosporine microemulsion are compared in maintenance heart transplant recipients with~     impaired renal function.~   "
258171|NCT00170846|"~     The study is designed to evaluate whether the initiation of everolimus together with the~     reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in~     the maintenance of renal transplant recipients with renal impairment by reducing the~     progression of chronic allograft nephropathy. The development of atherosclerosis in the~     native arteries of the patients will also be explored.~   "
258172|NCT00170833|"~     This study will assess the safety and efficacy of everolimus with basiliximab,~     corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal~     transplant recipients.~   "
258173|NCT00170820|"~     The purpose of this study is to assess if a combination of everolimus, steroids, and~     mycophenolate mofetil is associated with a better renal function than sirolimus.~   "
258174|NCT00170794|"~     The purpose of the study is to determine the extent of cyclosporine microemulsion dose~     reduction required to maintain stable renal function in maintenance cardiac transplant~     recipients, after initiation of everolimus.~   "
258966|NCT00160277|"~     The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian~     subjects.~   "
258175|NCT00170781|"~     This study is designed to develop our understanding of the efficacy and safety of using~     lumiracoxib in the treatment of patients with acute gout. This is a multi-center,~     double-blind, randomized, parallel group study comparing a single daily dose of 400 mg~     lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms~     of efficacy~   "
258176|NCT00170768|"~     The purpose of this study is to explore the possible cognitive effects of darifenacin~     modified release and long-acting oxybutynin.~   "
258177|NCT00170755|"~     This study will evaluate the safety, tolerability and efficacy of darifenacin, in the~     long-term treatment of adult patients with overactive bladder.~   "
258178|NCT00170742|"~     Phase III study comparing monthly octreotide i.m. in comparison to no additional treatment in~     patients with proliferative diabetic retinopathy after lasercoagulation.~   "
258179|NCT00170729|"~     The primary objective was to demonstrate that two days of treatment with 0.5% prednisolone~     acetate eye-drops after cataract surgery are superior to vehicle in reducing the flare in the~     anterior chamber of the operated eye.~   "
258180|NCT00170716|"~     The purpose of this study is to assess the safety and effectiveness of cortical stimulation~     delivered concurrent with rehabilitation activities to enhance motor recovery in patients~     suffering from hemiparesis affecting the upper extremity following a stroke.~   "
258181|NCT00170703|"~     The primary objective of this feasibility study is to evaluate the safety and effectiveness~     of targeted sub-threshold epidural cortical stimulation delivered concurrent with~     speech-language rehabilitation activities to enhance recovery in study subjects suffering~     from Broca's aphasia (the inability to speak or to organize the muscular movements for~     speech), following a stroke.~   "
258182|NCT00170690|"~     Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of~     therapy for the patient)~   "
258183|NCT00170677|"~     Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to~     be examined.~   "
258184|NCT00170664|"~     The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the~     current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I~     study now a multi-center phase II-trial was conducted.~   "
258185|NCT00170638|"~     The purpose of this study is to gain a better understanding of how immunity to tuberculosis~     (TB) is maintained in children. When children get tuberculosis, it is more likely to spread~     to other parts of the body than when adults get it. This study will compare the blood cells~     that fight TB in children to the blood cells that fight TB in adults. Children enrolled in~     this study will have blood drawn on 1 or 2 occasions. Adult participants will be~     leukapheresed, a process in which blood passes through a machine collecting specific blood~     cells and returning the remaining blood to the body. An estimated 260 subjects will be~     enrolled in this study.~   "
258186|NCT00170625|"~     Compatibility of the topotecan therapy in combination with carboplatin.~   "
258187|NCT00170612|"~     Pneumonia is the most common reason for admission of Fijian children to hospitals. The most~     common germ causing pneumonia is streptococcus pneumoniae. It is a common cause of~     meningitis (infection around the brain and spinal cord), ear infections, and blood infections~     and it lives in the nose of humans. A vaccine has been developed that will help prevent these~     common diseases but prevents only about one quarter of pneumonia cases and it is expensive.~     This study explores new ways of giving this vaccine that are affordable, safe, and effective~     in countries such as Fiji. About 550 Fijian infants presenting at 6 weeks of age, for their~     first diptheria, tetanus, toxoid, pertussis vaccine immunization, to one of the participating~     Health Centers or Colonial War Memorial Hospital in urban Suva, Fiji will be enrolled.~     Children will remain in the study for 2 years. Study procedures include full vaccination~     against 7 types of pneumococcus, blood tests, and nasal swabs.~   "
258188|NCT00170586|"~     Bloodborne pathogens are infectious bacteria, viruses, or other disease-causing germs carried~     in blood or other body fluids. These germs include hepatitis B and C viruses and HIV.~     Surgical and examination gloves are worn by health care workers to reduce the risk of workers~     catching germs from patients or patients catching germs from workers. The purpose of this~     study is to further develop polyvinylidene fluoride coatings for use as a protective coating~     worn underneath the gloves. Some health care workers may have tiny cuts on their hands that~     need to be protected, and gloves can have defects such as tiny holes that can allow germs to~     travel through them. The undercoating can add an additional layer of protection under gloves.~     The coating is applied in liquid form to hands and dries as a film without wrinkling,~     tearing, lifting, or bubbling. The liquid contains chemicals that fight germs. The coating~     also provides protection from skin irritation caused by the latex in some gloves.~   "
258189|NCT00170573|"~     Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of~     recurrent ovarian cancer (ROC). Toxic skin reactions were reported as being the dose-limiting~     toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study~     was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL~     was investigated. Secondary objective of this study was to evaluate the response rates of~     this new regimen.~   "
258190|NCT00170560|"~     The purpose of this study is to better understand the relationship between gender (being a~     man or a woman), infections caught in the hospital, and serious illness. Five hundred seventy~     patients 18 years of age or older who are critically (seriously) ill and admitted to the~     Intensive Care Unit (ICU) for at least 48 hours will participate in this study. Patients will~     be studied while receiving regular ICU treatment according to local standards. Blood~     specimens will come from patients either as wasted blood (University of Virginia) or blood~     collected from patients specifically for the study (Vanderbilt University). All patients will~     be followed daily until death or discharge from the ICU. The researchers believe that they~     will find a similar risk of infection for men and women overall.~   "
258191|NCT00170547|"~     This protocol is to compare the immune response of different influenza vaccines given by two~     different routes of administration in healthy adults ages 18 to 64 years.~   "
258192|NCT00170534|"~     The specific aim of this study is to complete an ongoing randomized controlled trial of the~     efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in~     decreasing risk behavior and incident HIV/STI infections in Mumbai, India.~   "
258193|NCT00170521|"~     The purpose of this study is to determine the epidemiology of throat isolates of group A~     streptococci among 3-15 year-old children with pharyngitis (sore throat) living in Leon,~     Nicaragua.~   "
258194|NCT00170508|"~     This is a complimentary study to an elderly influenza study. Subjects 18-40 will receive a~     single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza~     antigens.~   "
258195|NCT00170495|"~     This study is designed to assess the causes and impact of acute respiratory illness (common~     colds, flu, bronchitis, pneumonia) in adults age 65 and older. One of the ways to determine~     the virus causing a particular illness is to get a blood specimen when a person is sick and~     again later and look for the body's specific responses that identify the virus. Approximately~     3000 subjects will be evaluated and their medical records assessed for details of recent~     illness and general health to help in understanding the subjects' current illness.~   "
258196|NCT00170482|"~     The body's immune system (fights infection) is known to decline during the aging process,~     resulting in an increased risk of catching infections. Vaccinations also are not as effective~     in protecting older people against infection as they are in younger people. The purpose of~     this study is to better understand how and why vaccines are not as effective in older people.~     The researchers believe that the immune response in older people who get a higher dose~     vaccine will be similar to the immune response in young adults who get the standard (lower)~     dose vaccine. This study is a substudy to a main study, evaluating flu vaccines in people 65~     years and older. Volunteers who are in the main study will be asked if they will participate~     in the substudy. The substudy requires them to give 2 additional blood samples for an~     in-depth look at their immune response to the flu vaccine given in the main study. Substudy~     volunteers will have up to 3 clinic visits and participate up to 28 weeks.~   "
258197|NCT00170469|"~     This is a dose ranging study comparing different vaccine schedules of rPA vaccine, for~     Anthrax, to the licensed dose of AVA, another Anthrax vaccine. Safety and the capability to~     induce an immune response will be evaluated.~   "
258198|NCT00170456|"~     This is a dose ranging study comparing different vaccine schedules of rPA vaccine for~     anthrax. Safety and the capability to induce an immune response will be evaluated.~   "
258199|NCT00170443|"~     This study will compare the safety and immunogenicity of three different dose levels of an~     experimental recombinant influenza HA protein vaccine to a standard inactivated influenza~     vaccine in heallthy elderly subjects ages 65-80. Blood and nasal secretions for assessment of~     antibody responses will be obtained from all subjects prior to and one month after~     vaccination.~   "
258200|NCT00170430|"~     The purpose of this study is to see if taking medication once a month can help to decrease~     the risk of vaginal infections. Additionally, researchers will study whether personal habits,~     such as douching, bathing, and sexual practices can influence the risk of vaginal infections.~     Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually~     transmitted diseases (STDs). Study participants will include 400 female prostitutes ages 16~     and older, living in Mombasa. Study procedures will include sexual behavior questions,~     physical examinations including pelvic exams, testing of vaginal and cervical secretions for~     STDs, urine collection and blood samples. Participants will receive 2 different types of~     pills to treat vaginal infections (metronidazole or fluconazole) or placebo (contains no~     medication). Participants will be involved in study related procedures for 1 year and will~     return to the study clinic at one month intervals.~   "
258201|NCT00170417|"~     The purpose of this study is to evaluate using an RCT the potential benefits of CBT for~     insomnia in the community~   "
258202|NCT00170404|"~     The purpose of this study is to see whether people who take vitamins along with the standard~     medicine for tuberculosis (TB) recover better and quicker than people who take only the~     standard medicine for TB. This study will enroll 600 men and women, who are age 18-65 years,~     have TB, and intend to stay in Dar-es-Salaam for at least 2 years from the start of TB~     therapy. Half the participants will have active TB and also HIV infection, and the other half~     will have TB alone. Half the volunteers will be given vitamins, and the other half will be~     given placebo (sugar pill with no vitamins) from the start of their TB therapy, through the 8~     months of anti-TB therapy, and up to 48 months. Participation in the study involves visits to~     the clinic, physical exams, home visits, and answering questions about personal health, foods~     eaten, household, occupation, and education. Volunteers will also provide blood, sputum, and~     urine samples.~   "
258203|NCT00170391|"~     The principal aim of the study is to evaluate if CBT for insomnia is associated with~     improvement in the PSG sleep of patients treated in primary care. Furthermore,the~     relationship between subjectively-assessed sleep and PSG sleep are investigated(at~     pre-treatment, at post-treatment, in relation to treatment change.~   "
258204|NCT00170378|"~     To study the safety and efficacy of early administration of Low Molecular Weight Heparin to~     patients with traumatic brain injury.~   "
258205|NCT00170365|"~     The study examined Restorative Yoga as a method of stress reduction for the HFA Addiction~     Medicine Clinic staff volunteers.~   "
258206|NCT00170352|"~     The purpose of this study is to study the effects of EARLY (no more than 24 four hours from~     injury) administration of extra amounts of oxygen on traumatic brain injury.~   "
258207|NCT00170339|"~     This is a pilot study designed to answer the question  Do men who are receiving methadone~     maintenance therapy have lower spinal bone densities compared with age-matched controls who~     are not receiving methadone therapy?~      The primary aim is to assess whether the mean or median spinal dual-ray energy x-ray~     absorptiometry (DEXA) scan results are different between these two groups of male patients.~     Primary measurements include: spinal bone densitometry by DEXA scan.~      The secondary aim is to examine the role of sex steroids in men receiving methadone~     maintenance therapy and their association with spinal bone density and sexual dysfunction.~     Secondary measurements include: serum testosterone, estradiol, lutenizing hormone, albumin,~     sex hormone binding globulin and Vitamin D levels; age; Brief Sexual Function Inventory;~     Dietary, smoking/alcohol use and physical activity; Medical history, surgical and medication~     use; length of time using illicit opiates and time on methadone maintenance therapy.~   "
258208|NCT00170326|"~     The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in~     patients with ventricular dysfunction within the permanent pacing population.~   "
273058|NCT00015236|"~     The purpose of this study is for the modeling of impaired judgement in cocaine abusers.~   "
258209|NCT00170313|"~     The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator~     (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for~     cardiac resynchronization) is equipped with the Conducted-Atrial Fibrillation~     (AF)-Response-Algorithm (CAFR). This algorithm is designed to maximize biventricular~     stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs.~     The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering~     from atrial fibrillation by quantification of the increase of biventricular pacing during~     atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular~     heart rate.~   "
258210|NCT00170300|"~     The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the~     mortality and morbidity of patients with heart failure due to left ventricular systolic~     dysfunction already receiving diuretics and optimal medical therapy.~   "
258211|NCT00170287|"~     The present standard of care for the management of unstable ventricular tachycardia (VT) in~     the setting of chronic coronary artery disease is the placement of an implantable~     cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation~     and/or antiarrhythmic medication in the event of recurrences causing frequent ICD~     interventions.~      The primary purpose of this randomized study is the assessment of recurrences of unstable VT~     in patients who undergo ICD implantation plus substrate ablation after the initial episode~     compared to patients who only undergo ICD implantation. Thus the primary purpose is an~     improvement in the quality of life. A decrease in mortality is not a primary purpose of this~     study.~   "
258212|NCT00170274|"~     The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms~     of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an~     indication for cardiac pacing according to the German guidelines. Medication is controlled~     throughout the study with a beta-blocker as the only antiarrhythmic drug.~   "
258213|NCT00170261|"~     This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a~     primary implantation of a loop recorder versus the conventional diagnostic cascade for~     syncope most likely due to cardiac arrhythmia.~   "
258214|NCT00170248|"~     Asthma is a health problem that afflicts many Canadians. Better methods are needed to provide~     primary care physicians with ways of implementing current guidelines into regular practice~     for optimal disease management. This study will test the benefits of providing computer-based~     decision-support for asthma to primary care physicians, with links to home monitoring for~     their patients. To add value and to ensure regular use for the physician for all of his/her~     patients, these computerized decision-support tools will be linked to an electronic~     prescribing and drug management system. The investigators will evaluate the effectiveness of~     the computer-based decision-support system by determining whether asthma patients of~     physicians who receive computer-assisted management tools have better disease control after~     33 months of implementation compared to asthma patients of physicians who have the electronic~     prescription and drug management system alone. To answer this question, the investigators~     will conduct a cluster randomized controlled trial in a population of approximately 100~     physicians in 40 clinics in Quebec, and a total of approximately 4500 of their patients with~     asthma.~   "
258215|NCT00170235|"~     The overall aim of this pilot study is to explore the feasibility of a randomized trial to~     test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing~     arm morbidity and increasing health-related quality of life (HRQL) post-surgery.~   "
258216|NCT00170222|"~     The role of antibiotic therapy in patients with COPD remains controversial. While the outcome~     of several clinical trials is in favour of antibiotics, the quality of these studies in~     insufficient. In this study the efficacy of doxycycline is compared to placebo. All~     concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.~      The investigators hypothesize that patients with an acute exacerbations will have a better~     outcome when treated with antibiotics.~   "
258217|NCT00170209|"~     Tuberculosis (TB) is spread by airborne transmission from adults with active contiguous TB to~     children, especially those living in the same household. Once children are exposed and~     infected they are at very high risk to develop active TB - which can be lethal if not~     detected and treated promptly. This makes it very important to detect TB infection as soon as~     possible, and treat this while it is still latent or dormant. Current therapy for latent TB~     infection is 9 months of Isoniazid; this is very effective if taken properly but because~     treatment is so long many children do not finish this. Four months of Rifampin is a~     recommended alternative. In adults this has been shown to be safer with much higher~     completion rates. However the effectiveness of this treatment is unclear, and is being~     studied in an ongoing study. The investigators plan to compare the safety as well as the~     acceptability and effectiveness of 4 months Rifampin with 9 months Isoniazid (standard~     treatment) in children in several sites in Canada and other countries.~      It is hypothesized that among children at high risk for development of active TB,~     intolerance/adverse events will not be worse (non-inferiority), among those randomized to~     4RIF compared to those randomized to 9INH. In addition completion of latent tuberculosis~     infection (LTBI) therapy will be significantly greater (superiority), and subsequent rates of~     active TB will not be significantly higher (non-inferiority) in children taking 4RIF.~   "
258218|NCT00170196|"~     The purpose of this study is to determine the efficacy of addition of corticosteroid therapy~     to antibiotics in patient admitted with Community-acquired pneumonia.~      The hypothesis is: Prednisolone in combination with antibiotic treatments is effective in~     improving clinical outcome in patients hospitalized with CAP.~   "
258235|NCT00169936|"~     Heart transplantation is a great procedure for selected patients with end-stage heart~     failure, but graft rejection remains a major factor limiting long-term survival despite~     continued advancement in the scientific skill of immunosuppression. The only reliable method~     used today to detect rejection is doing repeated biopsy of the heart. This is expensive,~     invasive, inconvenient to the patient, and associated with a significant risk of serious~     complications, as a piece directly from the inner surface of the patients heart is needed.~     The magnetocardiograph (MCG) device is an invention that may provide new means to assess~     changes in the heart tissue, as it may detect small changes that happen in the heart cells~     when they are undergoing rejection.~   "
258603|NCT00165048|"~     The purpose of this study is to investigate the effect of selective COX-II inhibitor in~     patients with regionally disseminated stomach cancer treated by palliative resection (so~     called R1 or R2 gastrectomy).~   "
258219|NCT00170183|"~     Patients hospitalized for treatment of decompensated heart failure (CHF) are at risk for~     prolonged length of stay (LOS) and frequent readmissions. Renal dysfunction and diuretic~     resistance contribute to this risk, particularly if renal dysfunction worsens during CHF~     treatment. Brain natriuretic peptide (BNP) is a hormone of myocardial cell origin with~     well-defined physiological effects which include arterial and venous vasodilation,~     suppression of adverse neurohumoral systems and favorable effects on renal hemodynamics and~     sodium excretion. Recombinant human BNP (Natrecor) is approved by the FDA for treatment of~     decompensated CHF as it has been demonstrated to lower filling pressures and improve~     symptoms. While clinical trials and the FDA support the use of BNP as adjuvant therapy in~     decompensated CHF, the extent of its efficacy in improving non-hemodynamic CHF parameters has~     not been fully defined.~      The objective of this clinical practice protocol is to determine whether use of BNP in~     addition to standard therapy, will preserve renal function and facilitate diuresis in~     patients with CHF and mild-moderate renal impairment (creatinine clearance > 20 but < 60~     ml/min) as compared to standard therapy alone. Patients admitted to the Mayo Heart Failure~     Service who meet entrance criteria will be randomized to standard clinical practice with or~     without a 48 hour infusion of BNP.~      The primary endpoints will be indices of renal function and diuretic response at 1, 2 and 3~     days and at discharge. Secondary endpoints will be neurohumoral function, LOS and 30-day~     readmission rate.~   "
258220|NCT00170170|"~     This study will investigate the clinical variables that may be used to predict who among the~     solid organ transplant recipients will develop cytomegalovirus (CMV) disease after completing~     antiviral prophylaxis.~   "
258221|NCT00170157|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such~     as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of~     androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry cancer-killing substances to them. Giving~     antihormone therapy together with ipilimumab may kill more tumor cells.~      PURPOSE: This randomized phase II trial is study how well giving hormone therapy and~     ipilimumab together works in treating patients with advanced prostate cancer.~   "
258222|NCT00170144|"~     With aging, there is a decrease in muscle mass and function especially in the energy~     storehouses of cells called mitochondria. Amino acids, the building blocks of protein, and~     insulin have been shown to increase muscle mitochondrial protein synthesis and thereby~     function. Branched chain amino acids which can only be provided in the diet seem to be key in~     this process. Therefore in our study, our aim is to study the effect of branched chain amino~     acids on muscle mitochondrial protein synthesis in both the young and elderly. By doing so,~     we can then elucidate if branched chain amino acid supplementation has future potential in~     improving quality of life and performance in the elderly. The study will involve blood~     sampling and needle muscle biopsy.~   "
258223|NCT00170131|"~     Samples from a large clinical trial comparing three immunosuppression regimens, two of which~     contained MMF, are used to identify the HCV viral quasispecies behaviour after liver~     transplantation~   "
258224|NCT00170118|"~     The majority of the study consists of standard of care treatment for people with low back~     pain that has lasted more than three months. Half of the participants in the study will~     receive physical therapy from physical therapists that have received additional training in~     an educational technique. In order to determine if there is a difference in patient outcome~     when the educational technique is used, you will be asked to complete five short surveys~     before receiving physical therapy (10 minutes total). A sample of the physical therapy~     sessions using the educational technique will be videotaped. The videotape will be of the~     physical therapist to prove they did use the educational technique, not of you the~     participant in the study. You will remain anonymous and will not be used and the tape will~     not be used for publication or presentation purposes. You will also be asked to complete one~     survey after participating in physical therapy (2 minutes), and all five short surveys (10~     minutes total) six weeks after your last physical therapy session.~      You will be put in one of 2 groups by chance (as in the flip of a coin). A computerized~     selection process will be used to assign participants to the study. You will not know if you~     are in the study group or the non-study group.~   "
258225|NCT00170105|"~     Study Objective:~        -  To examine the perceptions of time spent at the bedside; perceptions of bedside manner;~          and patient perceptions of the provider-patient interaction offered by emergency~          providers when they sit versus when they stand during the initial evaluation.~      This project is clinically relevant research different from prior Emergency Department (ED)~     satisfaction studies since this study will contribute information about factors that could~     increase patient satisfaction with his/her provider in the ED setting. This research may~     guide specific guidelines for quality improvement efforts. The investigators hypothesize that~     patients will perceive that the emergency providers are at the bedside longer, demonstrate~     better bedside manner, and have better provider-patient interactions when they sit versus~     when they stand. Additionally, the investigators hypothesize that providers who sit will~     perceive that they are at the bedside longer than those who stand for the same period of~     time.~      Methods: A convenience sample of adult patients will complete a 5-item questionnaire~     concerning the perceived time spent with the emergency provider and the qualities of the~     provider-patient interaction. Emergency providers will be randomly assigned to either sit or~     stand during the initial evaluation. The providers will complete a 4-item questionnaire.~     These data will be compared to the actual time spent in the evaluation, measured in seconds,~     using a stopwatch. These data, combined with demographic data obtained from the patient~     chart, will be analyzed to examine whether there are statistically significant differences in~     patient perceptions and satisfaction.~   "
258236|NCT00169923|"~     The purpose of this study in patients with stage 4 and 5 chronic kidney disease is to~     determine whether rosiglitazone can reduce inflammatory markers and to investigate its effect~     on intima media thickness, calcification and pulse wave velocity.~   "
258304|NCT00169026|"~     The purpose of this study is to examine the short - term effects of clozapine on alcohol use~     in persons with schizophrenia and an alcohol use disorder. The hypothesis is that clozapine~     will have greater efficacy in reducing alcohol use than other antipsychotic medications.~   "
258305|NCT00169013|"~     To investigate whether gabapentin can prevent phantom and stump pain after amputation.~   "
258226|NCT00170079|"~     Smoking is the number one preventable cause of morbidity and mortality in this nation.~     Unfortunately, more than 50% of those who quit following a smoking cessation intervention~     typically relapse within two weeks, with approximately 80% relapsing within six months.~     Therefore, tobacco use can be conceptualized as a chronic condition. As with many chronic~     medical problems, tobacco use interventions may benefit from a step care approach to~     treatment.~      A total of 400 adult smokers will be enrolled in the study. Participants will be randomly~     assigned to one of two treatment conditions consisting of: 1) A State of the Art Smoking~     Cessation Intervention + Recycling or: 2) A State of the Art Smoking Cessation Intervention +~     Step Care. Long term smoking cessation will be assessed by self-report, exhaled carbon~     monoxide levels, and salivary cotinine. The primary endpoint of the study will be smoking~     abstinence rates at two-year follow-up. It is predicted that long-term cessation rates will~     be significantly higher in the step care condition than for those assigned to the recycling~     group.~   "
258227|NCT00170053|"~     Kidney transplant patients will be treated with Thymoglobulin (5 days), tacrolimus (Prograf),~     and mycophenolate mofetil (Cellcept) from the time of transplant. They will only receive~     steroids for 4 days and no prednisone after that. At 1 month, they will have a kidney biopsy~     and if it is ok, patients will be treated long term with either continued~     tacrolimus/mycophenolate mofetil or be switched to sirolimus (Rapamune)/mycophenolate~     mofetil. This will be done randomly in a manner similar to flipping a coin. The investigators~     are trying to determine if after the initial therapy patients can stay off steroids long term~     and get better kidney function if they are treated with sirolimus compared to tacrolimus.~     Patients will be followed for 3 years and will repeat kidney biopsies at 1 and 2 years after~     transplant.~   "
258228|NCT00170027|"~     A magnetocardiograph (MCG) is a medical device capable of recording the magnetic fields that~     arise from the electrical activity of the heart. It was developed for the general purpose as~     a noninvasive, non-contact diagnostic tool of obstructive coronary artery disease (CAD), and~     especially of cardiac ischemia. The overall objective of the present study is to demonstrate~     the efficacy of this MCG device in the diagnosis of lack of oxygen to an area of the heart~     (as in an Heart attack) in patients presenting with chest pain.~   "
258229|NCT00170014|"~     magnetocardiography has been extensively studied focusing on the possible clinical~     applications of the device. Evaluating the precision of a device is a prerequisite condition~     to know what are significant changes and how can these be trusted. A respectable~     reproducibility study for the MCG measurements is crucial for this new device to be used for~     clinical applications. In this study, we will focus on a critical portion of the heart cycle~     assessing for changes in time of the computerized analysis of this phase and comparing the~     analysis done by two examiners.~   "
258230|NCT00170001|"~     The investigators hypothesize that persons with the particular cluster of symptoms that are~     due to supraesophageal reflux (SER) will have complete resolution of those symptoms with~     adequate acid suppression when a PPI is administered for 6 months.~   "
258231|NCT00169988|"~     The Recognition and Prevention (RAP) Program is conducting a research study comparing an~     antidepressant, sertraline, alone versus in combination with a second-generation~     antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts,~     suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention~     and social skills in adolescents.~   "
258232|NCT00169975|"~     A magnetocardiograph (MCG) is a device capable of recording of magnetic fields arising from~     the electrical activity of the heart with traces similar to an electrocardiogram (ECG). This~     system was developed as a noninvasive, non-contact diagnostics of obstructive coronary artery~     disease (CAD), and especially of lack of oxygen in the heart as in a heart attack. The~     overall objective of this study is to demonstrate the efficacy of this MCG device for the~     detection and diagnosis of lack of oxygen of the heart in patients with chest pain.~   "
258233|NCT00169962|"~     Even with current standard ED treatments 20-25% of patients presenting to the ED with an~     acute asthma episode will still require hospitalization. For patients unresponsive to~     beta-agonists the admit rates will be higher. Of those well enough to be discharged from the~     ED nearly 30% will relapse within one month. More than 5,000 patients with asthma still die~     each year in the USA. For patients who do not respond to beta-agonists, there are relatively~     few treatment options for rapid improvement of symptoms and pulmonary function. Presumably,~     mucous secretion and plugging play an important role in the pathogenesis of severe asthma~     unresponsive to beta-agonists. The use of agents to promote clearance of intra-luminal~     secretions and mucous plugs may represent an important advance in the management of acutely~     ill asthmatics, both to hasten recovery and prevent deterioration in the acute care setting~     and to prevent relapse after discharge from the ED.~      OBJECTIVES~      2.1 Study Hypothesis: rhDNAse can be safely used in patients presenting to the Emergency~     Department with acute moderate-severe asthma who do not have adequate responses to~     beta-agonists~      Project Specific Aim: This is a pilot study to determine the safety of three different doses~     of pulmozyme® (2.5mg, 5.0mg and 7.5mg) in patients presenting to the ED with acute asthma. In~     addition to safety trends for improvement in pulmonary function and clinical outcomes will be~     monitored and data analyzed. Based on the safety profile and observable responses to~     treatment, this information may be used to develop larger trials to determine the efficacy~     and dosing strategy for treating acutely ill asthmatics with rhDNAse.~   "
258234|NCT00169949|"~     The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole.~     This drug has been approved for treating symptoms associated with schizophrenia and is~     associated with fewer side effects. This study will explore how well Aripiprazole treats~     symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for~     such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social~     isolation, and sudden changes in functioning.~   "
258237|NCT00169910|"~     This is a prospective randomized study to compare the influence of area under the curve~     (AUC)-monitored dual treatment with steroids in combination with either a calcineurin~     inhibitor (CNI) or mycophenolate mofetil (MMF) on the progression of subclinical~     cardiovascular disease in renal transplant recipients.~      Since CNI have a detrimental effect on cardiovascular risk factors, it is the researchers'~     hypothesis that renal recipients after CNI withdrawal will have more reduction of markers of~     cardiovascular disease.~   "
271399|NCT00032929|"~     The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment~     of cocaine dependence.~   "
258238|NCT00169897|"~     Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality~     of life of chronic obstructive respiratory disease (COPD) patient is well known. However,~     there is an important gap between the scientific knowledge and the clinical use of pulmonary~     rehabilitation since a a very small number of patients benefit from this therapeutic~     intervention. We estimate that less than 1% of the 750 000 canadians suffering from COPD have~     access to a pulmonary rehabilitation program. We want to study the efficacy of a home-based~     rehabilitation program as a way to facilitate the access to rehabilitation.~   "
258239|NCT00169884|"~     The purpose of this study is to evaluate whether the proposed cognitive-behavioural~     intervention is effective for DSH patients in the age group 15-35 years. In addition, we will~     examine which elements derived from the theoretical model can explain the efficacy of the~     intervention.~   "
258240|NCT00169871|"~     The objective of this proposal is to study the applicability of the hs-CRP assay in the~     assessment of CV risk in daily clinical conditions where hyperlipidemic population with or~     without CHD are currently evaluated.~   "
258241|NCT00169858|"~     Hepatitis B immunization has been offered to all grade 4 students (age 9-10) in the province~     of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs~     between age 15 and 35; the proportion of vaccinated children who will still be protected at~     this age is currently unknown. This study is designed to determine:~        -  persistence of immunity until age 25~        -  persistence of immunological memory as demonstrated by an anamnestic response following~          a booster dose~        -  the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the~          primary vaccination course (at age (15, 20 or 25).~   "
258242|NCT00169845|"~     Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of~     antioxidant vitamins and minerals are associated with increased risks of cancer, especially~     for epidermoid tumors. Patients with stage I or II head and neck cancer have a good~     prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site.~     However, the benefit of treatment is often compromised by the occurrence of second primary~     cancers, which develop in 20% of patients during the first 5 years after diagnosis. We~     conducted a randomized chemoprevention trial among patients with head and neck cancer treated~     by radiation therapy to determine whether supplementation combining two antioxidants,~     alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in~     this patient population (primary objective of the trial). This study was conducted with funds~     from the NCIC (#008176,004738,013211) and was completed.~      In this cohort of head and neck cancer patients, we evaluated whether nine potential~     prognostic serum markers measured at the time of diagnosis were related to recurrence,~     occurence of second primary cancers and survival. This study was conducted with funds from~     the NCIC (#018100) and was completed.~      Presently, we evaluate genetic polymorphisms(GWAS) associated with prognosis (NCIC grant~     #019502). We also assess the relationship between vitamin D (dietary intake, serum level, and~     genetic polymorphisms of key vitamin D-related genes) and head and neck long-term outcomes~     (NCI grant #1R03CA141615-01).~   "
258243|NCT00169832|"~     HYPOTHESES~        -  Rosiglitazone in diabetic patients with previous coronary bypass surgery may prevent or~          slow the progression of atherosclerosis in SVGs and native coronary arteries.~        -  Rosiglitazone has favorable effects on adipose tissue distribution variables as well as~          on thrombosis, pro-inflammatory, and lipid profiles in diabetic patients after coronary~          bypass artery surgery.~        -  Rosiglitazone therapy influences favorably metabolism and clinical outcomes in diabetic~          patients after coronary artery bypass surgery.~      OBJECTIVES~        -  PRIMARY To assess the efficacy of rosiglitazone to reduce atherosclerosis progression in~          vein grafts in diabetic patients after coronary bypass surgery by using IVUS imaging~          after a 12 mo follow-up.~        -  SECONDARY~             -  To prospectively compare the secondary IVUS endpoints.~             -  To prospectively compare the angiographic endpoints.~             -  To prospectively compare the metabolic risk factor endpoints.~             -  To prospectively compare the body composition and distribution endpoints.~             -  To prospectively compare the clinical outcomes of rosiglitazone versus standard~               care using composite endpoints.~   "
258244|NCT00169819|"~     HYPOTHESES~        -  Discharge on the same day after uncomplicated trans-radial coronary artery stenting is~          safe and effective.~        -  Hospitalized patients can be safely returned to the referring center the same day~          following trans-radial coronary artery stenting.~        -  Abciximab given as a single bolus with optimal trans-radial coronary artery stenting is~          as safe and effective as bolus + 12 hrs perfusion and does not hamper early discharge.~        -  Same-day discharge is cost-effective and increases patient satisfaction.~      OBJECTIVES AND END-POINTS~      The objectives of the present study are to assess the effectiveness and safety of same day~     hospital discharge after uncomplicated coronary artery stenting when a single bolus of~     Abciximab is used. The primary end-point of the study is the composite of death, myocardial~     infarction, repeat hospitalization, urgent revascularization, severe thrombocytopenia, access~     site complications and major bleedings at 30 days following stent implantation.~      The secondary end-point is the composite of death, myocardial infarction, repeat target~     vessel revascularization at 30 days, 6 months and 1 year following stent implantation. Other~     secondary end-points include the total hospital stay (days) between the index procedure and~     the first 30 days follow-up, the number of unsolicited medical visits in relation with the~     percutaneous procedure, index of patient satisfaction and direct and indirect costs.~   "
258245|NCT00169806|"~     Kidney stones are very common. They affect 3-5% of the population in the United States. Many~     people are hospitalized for the treatment of kidney stones and some may die. Better~     understanding of what causes kidney stones is useful in both the treatment and prevention of~     kidney stones. However, exactly what causes kidney stones is unknown.~      The most common type of kidney stones contains calcium, which sometimes is attached to a part~     of the kidney important in producing the final urine, called the papilla. The investigators~     have noticed that persons who form kidney stones seem to have more papilla with stones~     attached. They propose to study these areas of the papilla, called Randall's plaques (named~     after their discoverer), in patients undergoing surgery for kidney stones.~   "
258270|NCT00169481|"~     Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered~     concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time~     of first vaccination.~   "
258246|NCT00169793|"~     Test the hypothesis that the new bariatric surgical procedures (BSP) increase stone risk, and~     will result in an increased incidence and prevalence of stone disease; the purpose is to~     determine if BSP patients require special management for stone prevention. This study does~     not include the bariatric surgery but enrolls subjects who are already scheduled for surgery~     with an affiliated surgeon. The study procedure is to collect 24 hour urines pre-and post~     surgically to evaluate the risk of kidney stone procedure after surgery.~   "
258247|NCT00169780|"~     Current practices of the diagnosis of urinary stones gives little information on the probable~     fragility of stones using shock wave lithotripsy (SWL), and many patients receive more SW's~     than is necessary to break up their stones. Indeed, some patients are treated with SWL when~     their stones cannot be fragmented using this technology. The investigators have ample~     evidence that computed tomography (CT) images of kidney stones can reveal significant~     internal structure in stones—structure that is likely to be useful in predicting stone~     fragility—but no one has explored the use of clinical helical CT for this purpose. Also, the~     investigators do not know the effect that the human body wall and kidney tissue will have on~     the resolution of kidney stone structure with helical CT.~   "
258248|NCT00169767|"~     Many options currently exist to relieve the symptoms caused by benign prostatic hyperplasia~     (BPH). At present, transurethral resection of the prostate (TURP) serves as the surgical~     standard to which all other operative treatments are compared. Although TURP provides~     excellent short and long-term results, this procedure has many potential risks and~     complications. The desire to avoid the potential risks of TURP and still achieve results of~     comparable durability has led to the development of alternative surgical procedures.~      One such surgical alternative in the treatment of BPH is holmium laser ablation of the~     prostate (HoLAP). HoLAP has been compared to TURP in a randomized clinical trial with~     comparable outcomes in both uroflow rate and symptom score improvements (Mottet, et al 1999).~     Use of the holmium laser in treating BPH provides specific advantages over TURP. The risk of~     dilutional hyponatremia is eliminated, as the holmium laser can be used in conjunction with a~     normal saline irrigant. In addition, the hemostatic properties of the holmium laser results~     in superior hemostasis, thus minimizing the risk of bleeding. HoLAP has been utilized for~     prostate glands up to 60 grams in volume, as larger glands become more inefficient to treat~     using a tissue vaporization technique.~      Recently, another laser technology has been introduced for the surgical treatment of BPH, the~     potassium titanyl-phosphate (KTP) laser. This modality can also be used to vaporize~     obstructive prostate tissue, and has been studied through single arm clinical studies.~     Short-term results are promising, with significant improvements in voiding symptoms and urine~     flow rates as well as minimal associated morbidity. However, to date a randomized comparison~     study between HoLAP and KTP laser vaporization of the prostate has not been reported. A group~     of investigators with extensive experience with both procedures intends to objectively~     compare these two procedures in a randomized clinical trial.~   "
258249|NCT00169754|"~     Urolithiasis is a common condition in the United States, and is associated with significant~     morbidity and even mortality. The most commonly occurring urinary calculi are comprised of~     calcium oxalate salts, and until recently, the pathogenesis of calcium oxalate calculi was~     poorly understood. New evidence, however, suggests that the development of calcium oxalate~     calculi may be intimately associated with hydroxyapatite (HA) plaque, also known as Randall's~     plaque, which is located on the renal papillae. The investigators have previously~     demonstrated that Randall's plaque originates in the thin ascending limb of the loop of~     Henle, and they have shown that Randall's plaque is composed of HA (Evan, Lingeman et al.~     2003). As well, the amount of Randall's plaque correlates with elevated levels of urinary~     calcium and decreased urinary volume, risk factors for the formation of calcium oxalate~     calculi (Kuo, Lingeman et al. 2003). In the course of these previous studies, the~     investigators have anecdotally noted that calcium oxalate stones are often found attached to~     Randall's plaque, an observation that others have reported as well (Prien 1949; Carr 1954;~     Cifuentes Delatte, Minon-Cifuentes et al. 1987). However, there has been no in-vivo, rigorous~     documentation of this attached stone relationship. Attached calculi represent an important~     point in the pathogenesis of calcium oxalate calculi, as they correspond to a moment in time~     where there is a continuum between the HA plaque of Randall and the calcium oxalate stone,~     thus linking the origin of plaque with the development of stone. A better understanding of~     the phenomenon of attached calculi will lead to a better understanding of how and why calcium~     oxalate stones form, which may ultimately direct future interventions to attenuate stone~     activity.~   "
258250|NCT00169741|"~     Patients with large or otherwise complex renal calculi are commonly treated by percutaneous~     nephrolithotomy (PNL; PERC). PERC requires the creation of an approximately 10 mm channel~     through the renal parenchyma, into the intra-renal collecting system, in order to effect~     stone fragmentation and extraction. Although the nephrostomy tract is confined to a small~     fraction of the renal parenchyma (approximately 1%), the trauma associated with the creation~     of the tract will affect blood flow and oxygen delivery to regions beyond the immediate site~     of injury. It is possible that this could result in a significant functional renal~     impairment. There are several reports describing the effect of PERC on renal function, but~     interpretation of these studies is difficult, due to a lack of uniformity in patient~     selection and variability in the timing of peri-operative evaluation. Recent data from the~     investigators' lab, obtained from a porcine model, suggest that, acutely, PERC causes a~     significant decrease in renal function as measured by para amino hippurate (PAH) clearance.~     The purpose of this study is to determine, in a rigorous and standardized fashion, the acute~     effects of PERC on renal function, as measured by nuclear renography.~   "
258251|NCT00169728|"~     The purpose of this study is to determine the immunogenicity and tolerability of the~     DTaP-IPV-HBV/Hib combination vaccine Infanrix hexa and the heptavalent pneumococcal conjugate~     vaccine Prevenar in pediatric recipients of allogeneic haematopoietic stem cell~     transplantation.~   "
258252|NCT00169715|"~     Historically, percutaneous treatment of stone-bearing caliceal diverticula has resulted in~     the best success rates when examining factors such as symptom relief and stone-free rates~     (Jones, et al, 1991). Many groups have reported modifications in their percutaneous approach~     which have reportedly improved patient outcomes, but these series have very limited~     populations. Another issue concerning stone-bearing caliceal diverticula centers on the~     etiology of stones formation within these areas. This topic remains a subject of debate, with~     conflicting data in the literature.~   "
258253|NCT00169702|"~     The study is a prospective, randomized, open-label study.~   "
258254|NCT00169689|"~     The study is a prospective, randomized, double-blind sham-controlled study.~   "
258271|NCT00169468|"~     The primary objective of this study is to evaluate the response rate and toxicity of the~     association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 +~     lymphoma patients, aged from 18 to 80 years~      The goal is to get a response rate at least at what observed with R-CHOP alone and will be~     evaluates with a sequential test.~      The other objective is to evaluate the toxicity~   "
258255|NCT00169676|"~     Recently, many centers have begun offering laparoscopic radical prostatectomy (LRP) as a~     minimally invasive therapy for localized prostate cancer.1-6 LRP may offer the advantages of~     improved neurovascular bundle sparing, a more precise urethrovesical anastomosis, shorter~     hospitalization, and decreased convalescence.~      Our group at Methodist Urology, LLC has extensive experience in laparoscopy and in treating~     prostate cancer and are planning to offer LRP. We intend to maintain a registry and database~     to document the outcomes with LRP.~   "
258256|NCT00169663|"~     Brushite kidney stones are a unique form of calcium phosphate stones that have a tendency to~     recur quickly if patients are not aggressively treated with stone prevention measures. Little~     research has been undertaken to better understand the clinical history and potential urinary~     abnormalities that may predispose one to these troublesome kidney stones.~   "
258257|NCT00169650|"~     The gold standard for the treatment of ureteropelvic junction obstruction (UPJO) is the open~     pyeloplasty. As a minimally invasive alternative, many centers are currently offering~     laparoscopic pyeloplasty (LP) as primary therapy for UPJOs. Recent data has shown that~     laparoscopic pyeloplasty has comparable success rates to open pyeloplasties and produces~     durable results. The researchers are compiling a registry and database to review outcomes of~     laparoscopic pyeloplasty patients.~   "
258258|NCT00169637|"~     This is a randomized controlled, parallel group, open label versus no treatment trial which~     evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short~     bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization;~     At the end of the first four months: the treated group will be followed within 6 months, the~     untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months~     after the end of the treatment period.~   "
258259|NCT00169624|"~     Peripheral and coronary endothelial dysfunction in type 2 diabetic patients may be influenced~     by therapeutics. Using Radial flow monitoring and myocardial perfusion magnetic resonance~     imaging, we designed a controlled randomized double blind study to test the hypothesis that~     endothelial dysfunction will be reversed following 3 months of Metformin administration vs~     gliclazide. 30 patients will be included.~   "
258260|NCT00169611|"~     Neurofibromatosis type 1 (NF1) is an autosomal dominant disorder with an estimated prevalence~     of 1/2190 to 1/6711. Attention deficit hyperactivity disorder (ADHD) has been reported to be~     common in NF1. We, the researchers at Hospices Civils de Lyon, designed a randomized, double~     blind, placebo controlled, crossover trial with a total follow-up duration of 9 weeks to~     evaluate the effect of methylphenidate (MPH) on the improvement on the simplified parents~     Conners' Rating Scale. In a parallel exploratory study we will compare the nature of~     attention deficit disorders in NF1 children to 30 ADHD NF1-free controls. Children aged 7 to~     12 years are eligible when their intelligence quotient (IQ) is between 80 and 120. Fifty~     subjects (25 for each period) were required for testing the primary study hypothesis.~   "
258261|NCT00169598|"~     This randomised study aimed at evaluating the medical and economical impact of positron~     emission tomography (PET) using fluorine-18-fluoro-deoxyglucose (FDG) in the therapeutic~     prescription in patients with Hodgkin’s lymphoma or with large B and P cell non-Hodgkin’s~     lymphoma. The median progression free survival, the costs and the quality of life are~     compared between two groups : Group 1: the results of conventional staging and of the PET are~     known before stem cell transplantation. Group 2: only the results of conventional staging~     before stem cell transplantation are known before stem cell transplantation.~   "
258262|NCT00169585|"~     Multicentric, national, prospective, parallel group, controlled. The Subjects in every center~     will be randomized and assigned to the pharmacologic arm or the one with the biochemical~     monitoring~   "
258263|NCT00169572|"~     This study was designed to assess the safety and efficacy of an investigational agent~     administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy~     induced nausea and vomiting.~   "
258264|NCT00169559|"~     An eight week comparison of the investigational drug GW590735, placebo, and the marketed drug~     fenofibrate intended to increase the levels of good cholesterol and decrease levels of bad~     cholesterol in healthy patients with low levels of good cholesterol and high levels of bad~     cholesterol.~   "
258265|NCT00169546|"~     Comparison of two asthma treatments by lung function measures.~   "
258266|NCT00169533|"~     The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to~     provide lapatinib to patients who had a positive response in previous lapatinib studies until~     lapatinib is available pending FDA approval.~   "
258267|NCT00169520|"~     The purpose of this study is to determine the dose regimen of SB-715992 in combination with~     docetaxel in patients with solid tumors. SB-715992 and docetaxel were dosed by 1-hour~     intravenous infusion every 3 weeks (on the same day). A patient may continue to receive~     treatment as long as they are benefiting from the treatment. Blood samples will be taken at~     specific times to measure the amount of both drugs in your body at specific times after the~     drug is given. Blood samples will also be taken for lab tests such as complete blood counts~     and clinical chemistries. Physical exams will be performed before each treatment with~     SB-715992. During the treatment phase, the patients will undergo regular assessments for~     safety and clinical response.~   "
258268|NCT00169507|"~     Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent~     pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with~     GSK Biologicals' 11-valent pneumococcal vaccine in Undeca-Pn-010 study.~   "
258269|NCT00169494|"~     Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and~     genitals in men and women. Several types of HPV infection are transmitted by sexual activity~     and, in women, can infect the cervix (part of the uterus or womb). This infection often goes~     away by itself, but if it does not go away (this is called persistent infection), it can lead~     in women over a long period of time to cancer of the cervix. If a woman is not infected by~     HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the~     consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing~     processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in~     young adolescents and women of 10-25 years of age at study start. Approximately 750 study~     subjects will receive different lots of the HPV vaccine administered intramuscularly~     according to a 0-1-6 month schedule.~   "
271400|NCT00032916|"~     The purpose of this study is to conduct a drug interaction study with NS2359 and cocaine in~     cocaine experienced volunteers.~   "
258272|NCT00169455|"~     Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring~     hospitalization of infants and young children in developed and developing countries and can~     be a frequent cause of death in children less than 5 years of age. GSK Biologicals has~     developed a vaccine against human rotavirus gastroenteritis. In this study, the~     immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or~     reconstituted in circumstances different from the recommendations: i.e. when not~     reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In~     addition, the effect of feeding will be explored for HRV vaccine reconstituted without~     buffer.~   "
258273|NCT00169442|"~     To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to~     assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.~   "
258274|NCT00169416|"~     This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and~     valaciclovir in children with chickenpox following oral administration of valaciclovir, for~     the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.~   "
258275|NCT00169403|"~     Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim~     of this study is to:~        1. evaluate the efficacy and safety of this treatment in patients with idiopathic~          generalised dystonia, 3 years after surgery and~        2. assess the recurrence of the motor symptoms after the switch off.~   "
258276|NCT00169390|"~     Smoking substantially inhibits the activities of both monamine oxidase (MAO) A and B enzymes.~      Aims of this study: to compare MAO activities and nicotine and cotinine in peripheral blood~     of smoking and nonsmoking pregnant women, in their placenta and in cord blood and relate them~     with the behavior of their newborns being observed during 48 hours after birth.~   "
258277|NCT00169377|"~     Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the~     medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some~     data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The~     aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency~     stimulation in patients with severe OCD.~   "
258278|NCT00169364|"~     Parkinson's disease is a frequent neurodegenerative disorder. Genetic forms of the disease~     have been recently identified. The monogenic form due to parkin mutation is responsible for~     many familial cases and sporadic forms. However, the relationship between the mutation and~     the genotype of patients is not fully established. The aim of this study is to compare~     clinical, metabolic and neuropsychological characteristics obtained in patients with parkin~     mutation with those of patients without parkin mutation.~   "
258279|NCT00169351|"~     Tourette syndrome is rare. In France, about 3000 patients have a severe form of the disease.~     The aim of this study is to collect clinical characteristics in 200 patients with Tourette~     syndrome.~   "
258280|NCT00169338|"~     Bilateral pallidal stimulation is effective in the treatment of patients with generalised~     idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal~     stimulation in patients with post-anoxic generalised dystonia or non-generalised primary~     dystonia.~   "
258281|NCT00169325|"~     Basal ganglia are involved in the control of motor, cognitive and emotional behaviours. The~     aim of this study is to precisely evaluate patients with basal ganglia focal lesions both~     with or without loss of psychic-self activation.~   "
258282|NCT00169312|"~     RATIONALE: Websites for nutrition education may be an effective method to help people eat~     more fruits and vegetables which may lower their risk of cancer.~      PURPOSE: This randomized trial is studying how well an internet-based nutrition education~     program works in preventing cancer in participants of health maintenance organizations.~   "
258283|NCT00169299|"~     Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms~     including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the~     medical community for these symptoms is hormone replacement therapy, which is estrogen and~     sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is~     known about how well these products work, or their safety. Few have undergone the kind of~     rigorous testing required of prescription drugs and little is known about their long-term~     effectiveness in relieving symptoms.~      The purpose of this study is to compare several over-the-counter herbal remedies to hormone~     replacement therapy. Our primary aim is to look at the effects of these remedies on your~     self-reported menopausal symptoms. We will also be measuring their effects on other factors~     known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density,~     vaginal cell structure, and blood clotting.~   "
258284|NCT00169286|"~     This study aims to adapt and pilot test two core elements of an organized care program~     (systematic telephone outreach and monitoring to improve quality and continuity of~     pharmacotherapy, and structured psychoeducational group programs focused on patient~     activation and self-management) in a population-based sample of patients with chronic or~     recurrent depression.~   "
258285|NCT00169273|"~     We propose to:~        -  Conduct cross-sectional assessments of depression, disability, health-related quality of~          life, eating patterns, and eating attitudes in a population-based sample approximately~          6000 women aged 40-60 with over-sampling of women with BMI greater than 30 kg/m2.~        -  Among obese women free of depression, enroll approximately 100 in a 6-month standard~          behavior therapy weight management program.~        -  Among obese women with significant depression, randomly assign 200 to either a 6-month~          standard behavior therapy weight management program or a combined cognitive-behavior~          therapy program focused on both depression and weight management.~        -  Complete follow up assessments of weight, depressive symptoms, and functional status in~          all three treatment groups for 12 months following enrollment~      Screening and follow-up data will be used to address the following questions:~        -  Association between depression and obesity among middle-aged women~        -  Specific effects of depression and obesity on functional status, disability, and health~          services utilization~        -  Impact of depression on participation in and outcomes of a standardized weight~          management program~        -  Benefit of combined treatment (focused on depression and weight management) above that~          of standardized behavioral therapy for obese women with significant depressive symptoms.~   "
258286|NCT00169260|"~     The goal of this study is to understand how information about smokers' health risks affects~     their attitudes, mood, and behavior.~   "
258287|NCT00169247|"~     Larynx preservation remains a very challenging approach in patients with larynx/pharynx~     cancer. A first attempt consisted of induction chemotherapy followed in good responders by~     irradiation. This approach allowed to preserve 60 % of the larynx without any significant~     difference in survival. The second attempt consisted of concurrent chemo-irradiation. This~     approach provided a higher larynx preservation rate but survival remained unchanged and~     mucosal toxicity was also higher. A third approach is currently under evaluation: induction~     chemotherapy followed by concurrent chemo-irradiation in good responders.~   "
258288|NCT00169234|"~     The purpose of this study is to give seniors different doses of a new pneumococcal vaccine~     called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out~     which amount gives the best immune response. The PCV7 vaccine is currently licensed by the~     FDA for use in infants and toddlers only.~   "
258289|NCT00169221|"~     This trial will be an open multicentric randomized phase II study comparing post-operative~     radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract~     carcinomas.~   "
258290|NCT00169208|"~     This study is a multicentric trial evaluating the efficacy of the RFM regimen in patients~     aged 18 to 75 years with relapsed/refractory follicular NHL.~   "
258291|NCT00169195|"~     The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in~     refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible~     for autologous transplantation.~   "
258292|NCT00169182|"~     The purpose of the study is to compare two regimen of chemotherapy used as first treatment~     for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy.~     The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study~     is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the~     chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the~     induction treatment are treated with radiation with a purpose of larynx preservation. Non~     responders patients will be treated with total laryngectomy.~   "
258293|NCT00169169|"~     Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with~     autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.~   "
258294|NCT00169156|"~     To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and~     rituximab in patients aged 60 to 80 years with previously untreated AIL.~   "
258295|NCT00169143|"~     Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3~     of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell~     lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international~     prognostic index (Aa-IPI).~   "
258296|NCT00169130|"~     The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in~     case of bcl-2 overexpression in non previously treated patients aged 60 years or less with~     low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal~     is to obtain a 15% increase of event-free survival at 2 years.~   "
258297|NCT00169117|"~     Although the use of mosquito nets has increased in Africa, many of the nets used are in a~     poor state, and not an effective barrier against mosquitoes. This pilot study examines~     whether subsistence farmers in rural Africa can be encouraged to repair their mosquito nets~     and use their bednets appropriately. Attitudes and practises on sewing and net use were~     examined in The Gambia and an intervention developed to promote net repair. Songs and posters~     were used to emphasise the importance of repairing nets and their correct use, and served as~     aural and visual reminders to repair nets now rather than postpone this household chore. The~     intervention was aimed at effectively and cheaply turning a poor net into a good one.~   "
258298|NCT00169104|"~     Trastuzumab or Herceptin is an antibody directed against Her-2. Her-2 is a growth factor~     receptor which is present on the tumors of 25% of patients with breast cancer. The addition~     of trastuzumab to chemotherapy has been shown in a randomized clinical trial to increase the~     response rate to chemotherapy, the duration of response to chemotherapy, and to improve the~     duration of survival of patients with metastatic breast cancer. The anticancer mechanism of~     action of trastuzumab is unknown, but it is possible that trastuzumab acts by promoting~     antibody-dependent cell mediated cytotoxicity (ADCC), or direct killing of cancer cells by~     immune cells, triggered by antibodies bound to the surface of the cancer cell. G-CSF is a~     drug which is a growth factor for certain types of immune cells. G-CSF has two favorable~     effects on ADCC. G-CSF increases the pool of circulating cancer-killing immune cells, and~     G-CSF increases the strength of binding of cancer-killing immune cells to a specific part of~     the antibody. Therefore, priming with G-CSF significantly increases the efficiency of ADCC,~     and four days of treatment with G-CSF has been shown to optimize ADCC in some studies. Recent~     data from the investigators' laboratory indicates that chemotherapy can augment ADCC directed~     against tumor cells.~      The investigators' hypothesis is that pre-treatment with the drug G-CSF would increase the~     effectiveness of chemotherapy given with trastuzumab.~   "
258299|NCT00169091|"~     This study will examine the physical responses brought on by clozapine and haloperidol in~     people experiencing their first episode of schizophrenia.~   "
258300|NCT00169078|"~     Attempts to understand the relationship malaria transmission intensity and antimalarial drug~     resistance had rested mainly on mathematical models. To date, except for two studies which~     reported reductions in the prevalence of drug resistance in Tanzania and Zimbabwe, no other~     field data addressed the impact of reducing malaria transmission by the use of vector control~     measures on antimalarial drug resistance. Thus whether vector control decrease or increase~     drug resistance remains a contentious issue. The aim of this study was to investigate the~     impact of insecticide-treated curtains (ITCs) on clinical and parasitological outcomes in~     children with uncomplicated malaria treated with chloroquine (CQ), on the prevalence of~     genetic markers of resistance to CQ and sulphadoxine-pyrimethamine (SP) and on the ability of~     children to clear drug resistant parasites. The therapeutic efficacy of CQ was studied in 9~     villages which used ITCs for 6-8 years and 9 villages with no history of ITC use. A~     cross-sectional survey was also conducted to estimate the prevalence of genetic markers of~     resistance to CQ and SP in asymptomatic children.~   "
258301|NCT00169065|"~     This study will determine the effectiveness of clozapine versus olanzapine in treating people~     with schizophrenia that has not improved with treatment.~   "
258306|NCT00169000|"~     The combination of capecitabine and docetaxel is given to treat several different types of~     cancer. Capecitabine is usually given by mouth for 14 days, and docetaxel is given IV on the~     first day of capecitabine. The effects of changes in the schedule of the combination of~     docetaxel and capecitabine has been examined in human breast cancer cells. A capecitabine~     by-product was given orally to breast cancer-bearing animals for 14 consecutive days.~     Docetaxel was given IV at a variety of times between days 1 and 15. The greatest reductions~     in the volume of the cancer were seen when animals were treated with docetaxel between days 6~     and 10. In two other breast cancer models, the maximal degree of delay in growth of the~     tumors was achieved when the animals were treated with docetaxel on day 8 of a 14 day course~     of capecitabine. The extent of tumor response was not explained by changes in tumor levels of~     the enzyme thymidine phosphorylase, which is thought to be the mechanism behind the~     interaction of capecitabine and docetaxel. In the breast cancer cells, capecitabine increases~     the level of proteins which promote death of cancer cells, and it inhibits the levels of~     proteins which block death of cancer cells.~      Our hypothesis is that capecitabine and docetaxel interact with each other, because~     capecitabine primes the pro-death machinery of the cell by increasing the ratio of~     death-promoting proteins to death-inhibiting proteins. Cells are more susceptible to killing~     by docetaxel when the pro-death machinery is activated by capecitabine.~      This is a safety study to find the highest dose of capecitabine that can be given safely for~     14 days, in combination with docetaxel given at a fixed dose on day 8. Once this dose of~     capecitabine has been determined, an additional nine patients with tumors that can be~     biopsied will be treated at this dose, and levels of capecitabine, its byproducts, and~     docetaxel will be measured in the bloodstream. Biopsies of tumors will also be taken before~     and after the docetaxel is given, and the levels of pro-death and anti-death proteins will be~     measured.~   "
258307|NCT00168987|"~     Malnutrition is a frequent symptom of various malignant diseases and is frequently observed~     in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as~     specific and anticatabolic acting substrate in cancer patients. Only few randomized trials~     are available which investigated the effect of EPA in form of an EPA-enriched, protein- and~     energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma.~      Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional~     state and quality of life in patients with other gastroenterological tumors and weight loss~     is investigated in this randomized prospective trial.~   "
258308|NCT00168974|"~     Fabry disease is a rare X-linked lysosomal storage disorder. The mutations result in a~     deficiency of the lysosomal enzyme α-galactosidase causing accumulation of glycosphingolipids~     in the vascular endothelial cells and many other tissues. An early sign of the disease is~     painful small fibre neuropathy presenting in two forms: 1. a constant burning sensation in~     the hand and feet and 2. Fabry crises consisting of attacks of excruciating pain. Given the~     X-linked inheritance, male patients are severely affected. Recently attention has been drawn~     to female patients whether they also show signs of nerve involvement.~      The purpose of this study is to evaluate the small fibre neuropathy in female Fabry patients.~     Correlation with X-chromosome inactivation will be attempted. Recombinant human~     α-galactosidase A is now available for patients. A part of this study is evaluation the long~     term efficacy of enzyme replacement therapy in female patients with Fabry disease and~     neuropathy.~      Male family members with Fabry disease will be examined.~   "
258309|NCT00168961|"~     Malnutrition is frequently occurring in patients with liver cirrhosis and is associated with~     a poorer outcome, as it determines life quality and affects both morbidity and mortality.~      Long term prognosis after liver transplantation also depends on the nutritional status.~      Therefore, the early diagnosis and intervention for malnutrition is an important issue in the~     clinical management of liver cirrhosis. However, oral intake has been shown to be~     insufficient due to disease related anorexia or concomitant drowsiness and confusion.~      Specific aims: To investigate the effect of early nutritional intervention via tube feeding~     on nutritional status, functional status (hand grip strength and peak flow), life quality and~     disease related complications such as intestinal permeability, and oxidative stress, as well~     as liver function.~   "
258310|NCT00168948|"~     - intermittent preventive treatment with SP in children to evaluate efficacy and safety of~     this drug combination in children in northern Ghana~   "
258311|NCT00168935|"~     Background: Malnutrition is frequently occurring in sick patients and is associated with a~     higher morbidity and mortality. Muscle dysfunction is a common finding in malnutrition which~     leads to a reduced functional status and quality of life.~      Specific aims: The purpose of the study is to evaluate the effect of a three month~     nutritional intervention with oral supplements on nutritional status, muscle function and~     quality of life.~   "
258312|NCT00168922|"~     Determination of response rate Assessment of toxicity and determination of time to~     progression~   "
258313|NCT00168909|"~     The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number~     of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women.~      primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed~     falls)~   "
258314|NCT00168896|"~     Comparison of two combination chemotherapies in the treatment of patients with SLCL~   "
258315|NCT00168883|"~     This is a randomized study to assess the efficacy and safety of chemotherapy with platin~     compared to chemotherapy without platin.~   "
258316|NCT00168870|"~     This study evaluates treatment with combination versus monotherapy for patients with~     metastatic ocular melanoma.~   "
258317|NCT00168857|"~     A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers~     (ARB) have been shown to slow the decline in kidney function of patients with type 2~     diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The~     purpose of this research study is to determine if after one year of treatment telmisartan~     (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg,~     another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR)~     100 mg in reducing the level of urinary protein (indicative of improved kidney function).~   "
258318|NCT00168844|"~     To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the~     Respimat inhaler in patients with COPD.~   "
258319|NCT00168831|"~     To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the~     Respimat inhaler in patients with COPD.~   "
258320|NCT00168818|"~     The objective of this study is to determine the comparative efficacy and safety of two oral~     regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin,~     in prevention of venous thromboembolism in patients with primary elective total hip~     replacement surgery.~   "
258321|NCT00168805|"~     A phase III, randomised, parallel-group, double-blind, active controlled study to investigate~     the ef ficacy and safety of two different dose regimens of orally administered dabigatran~     etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on~     the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days,~     in prevention of venous thromboem bolism in patients with primary elective total knee~     replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)~   "
258322|NCT00168792|"~     To show whether addition of thrombolytic treatment by a single bolus injection of~     tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve~     the clinical outcome in patients with large acute myocardial infarcts as compared to primary~     PCI alone.~   "
258323|NCT00168779|"~     The primary objective of this study is to compare the effectiveness of telmisartan 80 mg /~     hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg / hydrochlorothiazide 25 mg~     [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.~   "
258324|NCT00168766|"~     The primary objective of this study is to determine whether combination treatment (adding~     methylprednisolone to Avonex) reduces progression of disability over 4 years compared to~     Avonex alone. The study will also investigate whether combination therapy has any impact on~     the incidence of relapse and brain atrophy as measured by MRI.~   "
258325|NCT00168753|"~     To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.~   "
258326|NCT00168740|"~     Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them.~     Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total~     of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week~     for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had~     a complete response and 70 patients had a partial response to rituximab. The median duration~     of response was 11.2 months.~   "
258327|NCT00168727|"~     The purpose of this study is to determine the safety and effectiveness of a treatment regimen~     using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin’s Lymphoma (NHL) or~     relapsed Non-Hodgkin’s lymphoma and have been previously treated. This study will use an~     experimental scheduling regimen. No chemotherapy will be used in this study.~   "
258328|NCT00168714|"~     The primary objectives of the study were to prospectively record and analyze birth defects~     and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within~     approximately 1 week of conception or during the first trimester of pregnancy, where the~     outcome of the pregnancy was unknown prospectively and to prospectively record and analyze~     pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who~     may have been exposed to Avonex with approximately 1 week of conception or during the first~     trimester of pregnancy.~   "
258329|NCT00168701|"~     Determine the efficacy,safety, and tolerability of BG00012 in MS patients.~   "
258330|NCT00168688|"~     Prenatal maternal micronutrient supplementation has been suggested as a means to reduce the~     proportion of low birth weight babies in low-income countries. The effects of prenatal~     multi-micronutrient supplements on birth weight and perinatal mortality were studied in a~     randomised controlled trial among 2100 pregnant women in Guinea-Bissau. Women up to 37 weeks~     pregnant were individually randomised to daily supplements until delivery of A) Iron + folic~     acid or multi-micronutrients in B) One or C) Two recommended dietary allowances. Secondary~     outcomes were infant growth and maternal haemoglobin eight weeks after delivery.~   "
258331|NCT00168662|"~     The general objectives of the proposed research work are:~      A1) to reduce childhood mortality in developing countries through better control of measles~     infection by finding the best immunization strategy, and A2) to investigate the hypothesis~     that standard titre measles immunization is associated with non targeted beneficial effects~     on childhood morbidity and mortality in developing countries.~      The measurable, specific objectives of the present proposal are:~      B1) to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age~     can reduce measles incidence by 50% through better coverage or improved seroconversion, and~     B2) to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age~     can reduce childhood mortality by 20% through better coverage, better protection against~     measles or non targeted beneficial effects, and B3) to determine the magnitude and duration~     of non-measles related changes in morbidity patterns after standard titre measles~     immunization, in particular to test whether measles immunization is associated with a 15%~     reduction in the risk of diarrhoea, and B4) to determine non-measles related immunological~     changes among recipients of measles vaccine in order to establish possible pathways for the~     non targeted effects of standard titre measles immunization.~   "
258332|NCT00168649|"~     Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after~     infusion with endotoxin in several animal models. We intend to examine the effect of vitamin~     A as pre-treatment on the response to endotoxin in humans. We furthermore wish to examine the~     long-term effects of vitamin A on the response to endotoxin. We hypothesise that vitamin A~     decreases endotoxin levels and TNF-alfa responses.~   "
258333|NCT00168636|"~     We previously compared the effect on mortality of the half dose and the full dose currently~     recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for~     boys. The girls' response might have depended on the last vaccine received before the OPV and~     VAS campaign. We believe that these findings call for confirmation. In connection with a new~     campaign, we will examine whether half the dose or the full dose has a more beneficial effect~     on mortality and morbidity in girls, and furthermore address the potential effect~     modification by the last vaccine received before the supplementation.~   "
258334|NCT00168623|"~     Vitamin A supplementation (VAS) is important for the immune system and may interact with~     different childhood vaccinations. We have hypothesized that the improved survival after VAS~     may depend on vitamin A amplifying the non-specific immune modulation induced by~     vaccinations.~      In the present study we used information collected in connection with a national vitamin A~     campaign in Guinea-Bissau during which different doses of VAS was provided together with~     missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions~     between VAS and vaccine type.~   "
258335|NCT00168610|"~     In the present study the investigators wish to address the effects of different doses of~     vitamin A supplementation in low and normal birth weight infants.~      Hypotheses:~        -  Vitamin A supplementation administered at birth together with BCG vaccination is~          associated with a 30% reduction in infant mortality and morbidity during the first year~          of life in both normal and low birth weight infants.~        -  A lower dose of vitamin A may be even more beneficial than a high dose.~   "
258347|NCT00168454|"~     The purpose of this study is to investigate whether injections of botulinum toxin Type A into~     the bladder are safe and effective in treating overactive bladder.~   "
258348|NCT00168441|"~     4-month study including a 30-day baseline phase~   "
258336|NCT00168597|"~     Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given~     at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG~     vaccination is associated with a 30% reduction in infant mortality and morbidity during the~     first year of life in normal birth weight children in an African setting.~   "
258337|NCT00168584|"~     Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio~     vaccine in national campaigns. However, it is not clear which dose is optimal. The two~     studies that have investigated the impact of different doses of vitamin A have both found~     that a smaller dose was better than a large dose. We therefore investigated if a smaller dose~     given with oral polio vaccine gives equal or better effect.~   "
258338|NCT00168571|"~     Few data exist on long-term persistence of measles antibodies after vaccination of West~     African infants. The data that do exist indicate that the antibody titres decline very~     rapidly. Our data would be the first to describe the persistence of measles antibodies after~     two doses of measles vaccine, and the study would allow us to identify unprotected children~     and offer them revaccination. Since persistence of measles antibodies is of crucial~     importance to measles control, the study will contribute significantly to the existing~     knowledge and might have important implications for future eradication programmes.~   "
258339|NCT00168558|"~     The specific aims are to examine in Guinea-Bissau:~        -  whether the standard titre Schwarz (SW) or standard-titre Edmonston-Zagreb (EZ) measles~          vaccine will be the best vaccine strain for use in a routine one-dose measles~          vaccination schedule and a two-dose measles vaccination schedule in terms of antibody~          response, protection against measles and child survival, and~        -  whether the standard-titre Edmonston-Zagreb (EZ) vaccine will be suitable for use in a~          very early two-dose schedule vaccinating at 4½ and 9 months of age~   "
258340|NCT00168545|"~     OBJECTIVES~        -  General: To investigate the immunological background for the non-specific effects of~          diphtheria-tetanus-pertussis (DTP) and measles vaccines on child mortality~        -  Specific: Examine the cytokine responses and possible association with morbidity in a~          study of DTP vaccinated children who will be randomised to receive a measles vaccine or~          no vaccine at 4½ months of age. (All children will receive a measles vaccine at 9 months~          of age)~   "
258341|NCT00168532|"~     Objective It is the objective to test whether the use of prophylactic antibiotics in measles~     infection will reduce the incidence of post-measles pneumonia and/or admissions to hospital~     with 50%. The possible impact on other complications of severe measles will also be measured.~   "
258342|NCT00168519|"~     The purpose of this project is to determine whether glucose metabolism can be improved by~     administering a substance (nitric oxide donor) normally released by muscles during exercise.~   "
258343|NCT00168506|"~     The reason for increased cardiac mortality in panic disorder has not been precisely~     identified, but possibly is due to chronic activation of the cardiac stimulant (sympathetic)~     nerves, which may predispose the individual with panic disorder to disorders of cardiac~     rhythm and coronary artery spasm. The uniqueness of this study lies in its comprehensive~     evaluation of a psychobiological approach to the treatment of panic disorder using change in~     biological, behavioural and psychological variables as criteria for efficacy. 50 patients~     aged between 18 and 60 years will be recruited; both males and females. They will be treated~     with either cognitive behavioural therapy (CBT) or SSRI (selective serotonin re-uptake~     inhibitor) antidepressants or a combination of both.~      This project will firstly compare individuals with panic disorder who demonstrate abnormal~     brain transmitter (noradrenaline, serotonin) with those who demonstrate normal activity of~     these neurotransmitters, on interoceptive accuracy for changes in sympathetic nervous system~     arousal. It is predicted that individuals who demonstrate abnormal activity of these~     neurotransmitters will also demonstrate enhanced interoceptive ability to detect changes in~     arousal levels. Secondly, this project will evaluate the effects of a psychobiological~     treatment approach to panic disorder involving a combination of CBT and SSRI. This approach~     will be compared to the effects of both these interventions alone on a comprehensive array of~     measures related to panic disorder. It is predicted that the combined approach will be the~     most effective intervention on behavioural, psychological and biological variables, and~     cardiac risk. We will also be able to assess whether changes in panic disorder severity are~     associated with changes in interoceptive accuracy.~   "
258344|NCT00168493|"~     We aim to determine why patients with depression are at an elevated risk for the development~     of coronary heart disease, and resolve whether the severity of a patient's depression has a~     counterpart in demonstrable abnormalities in brain chemistry. Studies will be completed in 28~     patients with depression; both males and females. Patients will be studied both untreated and~     during administration of a selective serotonin re-uptake inhibitor (SSRI) antidepressant.~     They will be either newly diagnosed with depression, untreated patients suffering a recent~     relapse, or patients seeking to switch from a non-SSRI antidepressant due to non-response.~     The turnover of chemical messengers in the brain will be estimated by high internal jugular~     venous blood sampling and DNA will be isolated and examined from blood cells. Immune function~     will also be assessed. Whole body and cardiac sympathetic nervous activity will be~     determined, as well as microneurographic recording of muscle sympathetic nervous activity.~      It is hypothesised that patients with depression and no existing demonstrable cardiac disease~     demonstrate:~      Alterations in brain monoaminergic neurotransmitter turnover, resulting in sympathetic~     nervous activation and dysregulation of the baroreflex control to both the heart (vagal) and~     muscle vasoconstrictor sympathetic nerves; and Exhibit enhanced platelet reactivity~     predisposing them to thrombogenesis and myocardial ischaemia.~      Therapeutic intervention with an SSRI will modify cardiac sympathetic function, baroreflex~     sensitivity or platelet reactivity in a fashion likely to reduce cardiac risk.~   "
258345|NCT00168480|"~     This is a three year open-label study in subjects with axillary hyperhidrosis.~   "
258346|NCT00168467|"~     One important clinical challenge in older individuals is maintaining mobility in the absence~     of pain. Peripheral arterial disease affects up to 12% of adults over 50 and impairs quality~     of life due to intermittent claudication causing pain and limiting mobility.~      Conventional therapies have only modest effect in improving symptoms. The investigators~     hypothesise that angiotensin converting enzyme inhibition (with ramipril), which causes~     arterial vasodilation, also improves clinical symptoms in patients with peripheral arterial~     disease.~   "
258353|NCT00168376|"~     The study will involve a 3-week (15 session) randomized double-blind clinical trial of two~     repetitive transcranial magnetic stimulation (rTMS) conditions in patients with treatment~     resistant depression. rTMS site selection will be localized from structural MRI scans.~      The patients will be randomized to one of two conditions~        1. rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,~        2. rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral~          prefrontal cortex targeted control).~   "
258354|NCT00168363|"~     This Study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or~     ocular hypertension~   "
258355|NCT00168350|"~     Randomized double-masked clinical trial of memantine in patients with glaucoma~   "
258356|NCT00168337|"~     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone~     for the treatment of diabetic macular edema.~   "
258357|NCT00168324|"~     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone~     for the treatment of macular edema associated with retinal vein occlusion.~   "
258358|NCT00168311|"~     There is pilot data to suggest the therapeutic value of rTMS applied to the left prefrontal~     cortex in the treatment of negative symptoms. Neuroimaging studies demonstrate abnormal~     activity in this region in patients experiencing negative symptoms. Finally rTMS applied at~     high frequency shows the capacity to up-regulate cortical activity in a way that would~     provide an explanation for a therapeutic response.~      The study involves participants receiving 15 sessions of high frequency rTMS treatment~     applied bilaterally to the prefrontal cortex over a 3 week period or sham rTMS. Following~     this double blind phase, participants randomised to placebo treatment will be offered 15~     sessions of active treatment.~      In addition, ppTMS (paired pulse TMS) will be conducted prior to the onset of treatment and~     after completion of the course, as a means of measuring cortical inhibition and facilitation.~     NIRS (Near Infra red spectroscopy) will also be conducted prior to, during and after the~     first and last treatment sessions to allow monitoring of oxygenated and deoxygenated~     haemoglobin.~   "
258359|NCT00168298|"~     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone~     for the treatment of macular edema associated with retinal vein occlusion.~   "
258360|NCT00168285|"~     Interstitial lung disease (ILD) is a highly disabling group of conditions including~     idiopathic pulmonary fibrosis (IPF), acute and chronic interstitial pneumonias, connective~     tissue diseases and sarcoidosis. People with ILD frequently experience breathlessness on~     exertion, which limits their ability to undertake daily activities. People with ILD report~     very poor quality of life due to low levels of physical functioning and vitality, and high~     levels of breathlessness and fatigue. There are few treatments for ILD and those that are~     available have limited impact on quality of life.~      The aim of this study is to assess the effects of Pulmonary Rehabilitation, which consists of~     specialised exercise training for people with lung disease, on exercise capacity and quality~     of life in people with ILD. We hypothesis that exercise training will result in reduced~     dyspnoea, improved exercise tolerance and enhanced quality of life.~   "
258361|NCT00168272|"~     The purpose of this study is to assist in understanding the most effective parameters for TMS~     in Depressive Disorders. Most research conducted has used high frequency stimulation on the~     left hemisphere.However, low frequency on the right hemisphere has also been shown to have~     antidepressant properties and appears to be better tolerated. A promising approach to improve~     responses to rTMS may be to combine high and low frequency stimulation where they are both~     applied to the right side of the brain. In this approach, high frequency stimulation is~     provided first which may 'prime' or pre-prepare the brain for low frequency stimulation in a~     way that enhances its response. Participants are randomised to receive active or placebo~     priming stimulation.If participants do not respond to this treatment condition after 10~     sessions applied over a two week period they will be offered 10 session of high frequency~     left sided TMS treatment. Alternatively, if participants respond favorably they may continue~     with that treatment condition for another 10 sessions.~   "
258362|NCT00168259|"~     The study is designed to evaluate interferon responses to CMV in HIV positive individuals and~     a component will look at interferon responses to CMV in HIV positive individuals over time~     after commencement of antiretroviral therapy. We will also look at the correlation between~     CD4 T cell numbers and HLA type with the interferon response.~   "
258363|NCT00168246|"~     This study will determine the prevalence of HIV-related neurological disorders in the~     countries of the Asia-Pacific Region.~   "
258364|NCT00168233|"~     To investigate the effect of treatment of HIV infection with highly active antiretroviral~     therapy on individual steps of reverse cholesterol transport, endothelial function and~     intima-media thickness in HIV patients.~   "
258365|NCT00168220|"~     A case-control study to look at hypersensitive and tolerant individuals matched for HLA~     genetic predisposition, when considering predictors of drug hypersensitivity.The study aims~     to identify the immunological factors increasing the risk of drug reactions in HIV positive~     individuals.~   "
258366|NCT00168207|"~     The aim is to investigate the hypothesis that IL7-receptor polymorphisms contribute to the~     differential immune recovery of CD4 + T cells following HAART~   "
258367|NCT00168194|"~     It remains unclear why some individuals are able to clear HBV from their bodies while in~     others HBV is a persistent infection. We plan to investigate this process by collecting blood~     and analysing how the patient's white blood cells respond to different pieces of the HBV~     virus. We will use new tools that can precisely tell us which component of the immune~     response may be different in individuals who are chronically infected with HBV and also in~     individuals who are also infected with HIV.~      The primary aims are therefore:~        1. To characterize HBV-specific T cell responses in HBV chronic carriers, and identify~          novel immunogenic regions in both HLA-A2+ and non-HLA-A2+ individuals.~        2. To determine the effect of HIV infection on HBV-specific T-cell responses~   "
258368|NCT00168181|"~     This is a study to see whether the drug Salagen or salivary gland transfer is better for the~     prevention of dryness of the mouth in patients with head and neck cancer receiving radiation~     treatment.~   "
258369|NCT00168168|"~     Evaluate recovery time on 2.5 mg/Kg/day dose of G-CSF versus 5 mg/Kg/day dose.~   "
258827|NCT00162110|"~     This is a Phase II open-label trial evaluating the efficacy, and safety of Erbitux in~     patients with mucinous gastrointestinal adenocarcinoma involving the peritoneal surface.~   "
258370|NCT00168155|"~     When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be~     removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere~     in the body. This study will determine if giving chemotherapy treatment before the surgery~     can reduce the chances that the cancer will come back.~   "
258371|NCT00168142|"~     To compare the two types of scans, the conventional CT planning scan and the tomotherapy~     planing scan.~   "
258372|NCT00168129|"~     To assess the safety and efficacy of a single fraction of radiotherapy using helical~     tomotherapy to treat bone metastases.~   "
258373|NCT00168116|"~     The purpose of this study is to compare the side effects of radiation treatment and surgery~     versus radiation alone, where no surgery is done to move the salivary gland and place it~     under the chin region where it can be shielded from radiation.~   "
258374|NCT00168103|"~     HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not~     treated adequately, the acute attacks of HAE can be life-threatening and may even result in~     fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study~     was designed to provide clinically relevant data on dosing, efficacy and safety in subjects~     with HAE.~   "
258375|NCT00168090|"~     The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent~     bleeding in patients with von Willebrand Disease who are undergoing surgery.~   "
258376|NCT00168077|"~     Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of~     acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a~     fast reversal of the anticoagulant effect, with several advantages over alternatives like~     vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically~     relevant data on efficacy and safety.~   "
258377|NCT00168064|"~     This study will evaluate the efficacy, tolerability and safety of the topical application of~     mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).~   "
258378|NCT00168051|"~     The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate,~     using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.~   "
258379|NCT00168038|"~     The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in~     the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main~     efficacy parameter is the proportion of patients responding to treatment by an increase of~     platelet count to ≥ 50 x 10^9/L.~   "
258380|NCT00168025|"~     The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of~     serious bacterial infections in patients with primary immunodeficiency.~      As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10~     are studied.~      A part of the patients are participating in a pharmacokinetic substudy.~   "
258381|NCT00168012|"~     The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of~     serious bacterial infections in patients with primary immunodeficiency.~      As secondary endpoints the rate of overall infections, the tolerability and safety of~     IVIG-F10 are studied.~   "
258382|NCT00167999|"~     To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and~     restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing~     Escherichia coli and Klebsiella pneumoniae in hematology and oncology units~   "
258383|NCT00167986|"~     To determine whether the restriction of 3rd generation cephalosporins and carbapenems~     contribute to the reduction of intestinal colonization or infection with vancomycin-resistant~     enterococci (VRE) in a medical intensive care unit (MICU).~   "
258384|NCT00167973|"~     This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX.~     All patients who begin treatment with BeneFIX in European Union countries, will be eligible~     for participation. Patient demographics will be collected at baseline for all patients. A~     baseline FIX activity and Bethesda assay for inhibitor based on historical data should be~     recorded if available. Adverse events as defined in the protocol will also be reported on the~     appropriate forms. Data will be collected from patients on an ongoing basis to ensure that~     information is being captured for each patient being treated with BeneFIX.~   "
258385|NCT00167960|"~     To determine the impact of the restriction of the third and forth generation cephalosporins~     on the reduction of intestinal colonization or infection with vancomycin-resistant~     enterococci (VRE) in a surgical intensive care unit (SICU)~   "
258386|NCT00167947|"~     Renal function at 12 months assessed by calculated creatinine clearance.~   "
258387|NCT00167934|"~     This study will determine the metabolic processes responsible for high levels of blood~     glucose, metabolism disorders, and weight gain in people with schizophrenia who have been~     treated with antipsychotic medications in combination with valproate.~   "
258388|NCT00167921|"~     The purpose of this study is to characterize the systemic exposure and bioavailability at~     steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in~     postmenopausal women with atrophic vaginitis.~   "
258389|NCT00167908|"~     The purpose of this study is to determine whether Amifostine provides additional protection~     of salivary gland function over that achieved with IMRT alone.~   "
258390|NCT00167895|"~     The objective of this study is to evaluate the effect of autologous platelet concentrate on~     blood loss (post-operative decrease of haemoglobin concentration), wound healing~     complications, range of motion, pain reduction and outcome scores when used in total knee~     arthroplasty.~   "
258391|NCT00167882|"~     The purpose of this study is to determine the influence of different 5-aminosalicylate~     concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with~     inflammatory bowel disease.~   "
258392|NCT00167869|"~     Hypertension is an increasingly important medical and public health issue. Literature~     suggests that there may be a role for dairy foods in the prevention and treatment of~     hypertension. Recently, it has been suggested that several peptides in milk proteins could~     have blood pressure lowering properties. LACTOPRES is a randomised, double-blind parallel~     trial to assess the blood pressure effect of an increased intake of dairy peptides in humans.~   "
258429|NCT00167388|"~     The purpose of the study is to see if a blood transfusion changes how fast blood flows to the~     intestines of a premature baby. Blood flow is measured by an ultrasound test. The~     investigators also look to see if the blood flow to the intestines depends on whether the~     baby feeds or doesn't feed during the blood transfusion.~   "
258393|NCT00167856|"~     The purpose of this study is to evaluate the pain-relieving effects of venlafaxine~     hydrochloride (Effexor) in chronic neuropathic (burning, shock-like, electric) pain after~     spinal cord injury (SCI). Although a number of medications have been used to treat SCI pain,~     no drug has been consistently helpful, and, therefore, many people with SCI continue to have~     difficult chronic pain. Venlafaxine is a new anti-depressant drug that has not been tested~     for use in SCI neuropathic pain, but has been helpful for other types of neuropathic pain.~   "
258394|NCT00167843|"~     The general goal of the project is to assess the infectious status and immunity of mothers~     and children living in a malaria region. A major part of the study involves administering an~     effective antimalarial, sulfadoxine-pyrimethamine (Fansidar®), to children at the same~     timepoints as vaccinations, i.e. at age 3, 9 and 15 months. The main objective is to study~     safety, efficacy, and consequences of such a strategy in particular the ability to reduce the~     risk of anemia.~   "
258395|NCT00167830|"~     The purpose of this study is to identify significant racial and ethnical differences in risk~     factors for development of obesity and weight loss in adolescents in Central Virginia~   "
258396|NCT00167817|"~     Patients with schizophrenia are much more likely to be engaged in smoking and other addictive~     behaviors, possibly related to biochemical abnormalities in the reward center of the brain.~     The primary purpose of the present study is to investigate whether switching patients with~     schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of~     action, will have an impact on smoking behavior.~   "
258397|NCT00167804|"~     Combat related Posttraumatic Stress Disorder (PTSD) is the most common chronic psychiatric~     disorder in the veteran population. Unfortunately, outcome studies of VA PTSD programs have~     failed to show efficacy. VA PTSD patients have been significantly less responsive to~     conventional therapies than other PTSD populations. Virtual Reality based exposure therapy~     (VRE) allows patients to feel immersed in highly interactive computer-generated environments.~     Within these environments patients can be exposed to anxiety-provoking stimuli in a gradual~     and controlled manner so that they can become desensitized to these stimuli and, in the case~     of PTSD, the traumatic memories evoked by these stimuli. The advantages of VRE include less~     reliance on the patient's ability to visualize traumatic memories and making it more~     difficult for patients to avoid memories during exposure therapy. It is also safer and more~     convenient than in vivo exposure. In this study twenty Vietnam veterans are randomly assign~     to either VRE or to a Treatment as Usual (TAU) control condition. Treatment would consist of~     ten ninety-minute individual psychotherapy sessions for both groups. Assessments would occur~     at pre-treatment, immediate post-treatment and at six months post-treatment.~   "
258398|NCT00167791|"~     This is a study of patients who have a high risk of kidney rejection before kidney~     transplant. The hypothesis is that treatment with a medication called rituximab will make it~     possible for them to receive a kidney transplant from a donor who previously did not present~     a good match.~   "
258399|NCT00167778|"~     The biomechanics of changing direction while walking has been largely neglected despite its~     relevancy to functional mobility. In addition, an increased risk of injury can be associated~     with turning due to a decrease in stability. The objective of this study is to understand the~     biomechanics of turning gait in sample populations of intact and trans-tibial amputees and~     the capacity of prosthetic components to facilitate transverse plane movement. The clinical~     impact of this investigation is the development of interventions that increase functional~     mobility, stability and safety while turning.~      The researchers propose to investigate three sets of hypotheses. The first set addresses the~     fundamental biomechanical mechanisms associated with walking along a circular trajectory, how~     intact subjects differ from amputees, and the effect of a rotation adaptor pylon. The second~     set of hypotheses addresses dynamic stability and the potential influence of prosthetic~     interventions. The third set of hypotheses addresses how the rotational properties of the~     prosthetic pylon can influence comfort and mobility during daily activities.~   "
258400|NCT00167765|"~     The purpose of the prospective, randomized, double blind, placebo-controlled multicenter~     pilot study is to evaluate the effectiveness of abciximab on rescuing the hypoperfused brain~     tissue, as assessed by MRI, and the relative safety of abciximab in patients with wake-up~     stroke.~   "
258401|NCT00167752|"~     The purpose of this study is to investigate the prevalence of depression, anxiety, and sleep~     problems in patients with chronic skin diseases in dermatology clinics at the University of~     Wisconsin Hospital and Clinics.~   "
258402|NCT00167739|"~     Quinine remains the treatment of choice of hospitalised malaria cases. The long treatment~     duration of 7 days, and adverse reactions often hamper its adequate use. Reducing the~     treatment duration by adding sulfadoxine-pyrimethamine may enhance compliance and reduce side~     effects.~      The efficacy of a 3-day treatment of quinine plus sulfadoxine-pyrimethamine for the treatment~     of hospitalised, uncomplicated malaria cases was assessed.~   "
258403|NCT00167726|"~     The purpose of this study is to collect longitudinal data on outcomes of neuraxial or~     neurolytic procedures in patients with intractable cancer and chronic noncancer pain so that~     we may contribute to the growing evidence for or against these therapies and to provide data~     for ongoing quality improvement activities.~   "
258404|NCT00167713|"~     Drugs to treat fever are widely used in children with fever. But there is a controversy about~     the benefit of reducing fever in children with malaria. Ibuprofen is often used to treat~     malarial fever. This study evaluates the capacity of ibuprofen to reduce fever in malaria.~     The effect of ibuprofen on fever compared to only mechanical measures is investigated in~     children with malaria.~   "
258405|NCT00167700|"~     Combined programme: Nutrition, Allergy, Mucosal immunology and Intestinal microbiota (NAMI)~     was created with the objective to reverse the rising trend of chronic inflammatory diseases,~     such as allergic disease and obesity, by control of the internal and external environments of~     the infant. To approach this problem, the project aims to characterize~        -  how immunology is regulated during pregnancy and early infancy,~        -  how the immune interaction between mother and child is influenced by nutritional and~          microbial factors, and~        -  how the regulation is related to disease risk.~   "
258406|NCT00167687|"~     This double-blind placebo controlled pilot trial will test the hypothesis that prazosin, an~     alpha-1 adrenergic receptor antagonist, reduced alcohol consumption and alcohol craving in~     alcohol dependent individuals without Post Traumatic Stress Disorder (PTSD). The intervention~     period is six weeks.~   "
258407|NCT00167674|"~     Identifying new approaches for preventing breastmilk transmission of HIV-1 is an important~     research priority. To this end, clinical trials are underway to evaluate the efficacy of~     HAART (zidovudine, lamivudine, nevirapine) during late pregnancy/lactation versus~     zidovudine/nevirapine peripartum for prevention of breastmilk HIV-1 transmission. It is~     important to understand the mechanism of effect of these antiretroviral (ARV) strategies on~     prevention of breastmilk HIV-1 transmission.~      This phase II trial will compare HAART vs peripartum zidovudine/nevirapine for effect on~     breastmilk HIV-1, breastmilk HIV-1 specific immune responses, and infant HIV-1 specific~     immune responses.~      100 pregnant HIV-1 seropositive women in Nairobi with CD4 counts between 200 to 500 who have~     chosen to breastfeed will receive either ARV regimen. Mother-infant pairs will be followed~     for 1 year after delivery. Home visits will be conducted in the first month (~10 visits) to~     collect 2-5 mls of breastmilk per visit. Mother-infant pairs will be seen in the study clinic~     with maternal blood and breastmilk and infant blood collected at months 1, 3, and 6 for HIV-1~     and HIV-1 Elispot assays. Breastmilk HIV-1 RNA and DNA levels will be quantified in Dr.~     Overbaugh's laboratory in Seattle and Elispot assays conducted in Nairobi with validation of~     a subset in Dr. Rowland-Jones laboratory in Oxford. Viral loads, decay curves, half-life, and~     re-population following ARV cessation will be estimated for each regimen and regimens~     compared. These studies will provide insight into the viral and immune responses to ARV~     regimens proposed for prevention of breastfeeding HIV-1 transmission and will be important~     for rational design of future interventions. After taking into account, estimated loss to~     follow-up, the targeted sample size with outcome data was 80 women, 40 in each trial arm,~     estimating undetectable breast milk HIV-1 RNA levels in the HAART arm and median breast milk~     HIV-1 RNA levels of 3.0 log10 in women receiving ZDV/NVP.~   "
258408|NCT00167661|"~     The purpose of this study is to determine whether Campath-1H induction and the associated~     lymphocyte depletion will permit long-term rejection-free renal allograft survival in the~     absence of ongoing corticosteroid administration.~   "
258409|NCT00167648|"~     Prostate cancer is the most commonly diagnosed cancer among males in the U.S. More than~     220,000 men will be diagnosed with prostate cancer in the USA this year and more that 31,000~     will die of this disease.~      Androgen deprivation, the elimination of testosterone and its active metabolites, remains the~     single most effective intervention available for the treatment of advanced prostate~     carcinoma. Androgen deprivation induces an immune response to normal prostate and prostate~     cancer, which is usually short-lived. Estradiol induces activation of many arms of the immune~     system and may be a more effective and long lasting means of inducing immunity to prostate~     tissue.~      This study will treat clinically localized prostate cancer patients with either estrogens, or~     standard androgen deprivation without estrogens, prior to prostatectomy in order more~     completely to describe immune regulation by estradiol in men. Control tissue from patients~     who have not been treated with androgen deprivation will be procured from the Northwest~     Special Projects in Oncology Research Excellence (SPORE) tissue core and used as comparisons~     against the cancers treated before prostatectomy. Tumors removed at prostatectomy, tissue~     samples and blood samples will be assessed for immune system changes.~   "
258410|NCT00167635|"~     The purpose of this study is 1) to determine whether a comprehensive self-management~     intervention is effective in a sample that includes men and women with irritable bowel~     syndrome, and 2) to determine whether the comprehensive self-management intervention is as~     effective when delivered over the telephone as compared to a face-to-face approach.~   "
258411|NCT00167622|"~     The purpose of this study is to determine whether early mechanical ventilation can prevent~     hospital acquired pneumonia in adults with Guillain Barré Syndrome.~   "
258412|NCT00167609|"~     To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with~     myotonic dystrophy~   "
258413|NCT00167596|"~     The purpose of this study is to evaluate the usefulness of an optimization of muscle~     perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with~     sepsis.~   "
258414|NCT00167583|"~     The purpose of this study is to investigate if interferon-alpha2a is superior to the standard~     treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcet`s~     disease.~   "
258415|NCT00167570|"~     The overall long-term goal of this project is the development of a clinically practical~     system for rapid prosthetic limb provision that integrates computer-aided design with solid~     freeform fabrication techniques. This proposal builds on our previous successful~     demonstration of the feasibility of SFF socket fabrication and will address several key~     issues that underlie its clinical viability. The specific objectives of the proposed work~     are:~        1. To develop improved designs for SFF transtibial prosthetic sockets that allow the use of~          industry standard pylon mounts and incorporate variable compliance elements.~        2. Determine the clinical effectiveness of variable wall compliance elements in enhancing~          the comfort and fit of transtibial prosthetic sockets.~        3. Determine the durability and functionality of SFF sockets during extended clinical use.~      These objectives will be met over a three-year period. The initial phase of the proposed work~     will use an iterative engineering design - modeling - evaluation process to develop variable~     compliance elements and an industry standard pylon mount adapter. During the second phase of~     the proposed work, clinical evaluations of SFF prosthetic sockets will be studied. The~     effectiveness of variable compliant elements in enhancing comfort and fit will be determined~     using a within subject case comparison study of SFF sockets with conventional laminated~     sockets. Durability of SFF sockets that incorporate an industry standard pylon mounting~     system will be determined during a 12-month clinical field trial.~   "
258416|NCT00167557|"~     After a liver transplant, the hepatitis C virus (which destroyed one's own liver) eventually~     comes back. In many patients, this will eventually cause the loss of the new liver and can~     also confuse the doctors taking care of them because it is hard to tell the difference~     between one's body rejecting the new liver and hepatitis. This can cause serious treatment~     errors that can lead to more severe hepatitis or to rejection of the liver. Some of the drugs~     used to prevent rejection of one's new liver can cause the hepatitis to come back in a more~     severe form. This is especially true for the drugs known as corticosteroids.~      Right now, the only effective treatment against hepatitis C is a combination of two drugs~     called interferon and ribavirin. These drugs act by strengthening one's immune system to~     fight the virus and by directly reducing the reproduction of the virus. Because the treatment~     with these drugs is associated with many side effects, there is little experience with~     treating patients after liver transplantation with them.~      In the investigators' transplant program, they have decided to treat all patients with~     hepatitis C as early as possible after transplantation and to follow them closely for the~     development of hepatitis and side effects of the treatment. The investigators treat one's~     hepatitis as early as possible, before any actual damage has occurred in the new liver. This~     approach has been tried before but it has been hard to tell if it has worked or not. The main~     reason for failure was that many patients could not complete the treatment due to side~     effects. The investigators' purpose is to treat those side effects aggressively so that most~     patients can complete the treatment course.~      The purpose of this study is to collect all the data regarding the investigators' treatment~     protocol so that they will be able to learn if this form of treatment is beneficial.~      The study includes performing liver biopsies at scheduled times after one's liver transplant~     and for scheduled blood tests to see how much virus is still in the blood. If patients show~     signs that they are not responding to treatment they will be removed from the study.~   "
258417|NCT00167544|"~     The purpose of this study is to determine whether treatment of very preterm infants at~     high-risk for lung and brain injury with low dose hydrocortisone results in improved~     pulmonary and neurologic outcomes.~   "
275253|NCT00000156|"~     To evaluate the effect of ambient light reduction on the incidence of retinopathy of~     prematurity (ROP).~   "
258418|NCT00167531|"~     Being able to walk is a major determinant of whether a patient returns home after stroke or~     lives in residential care. For the family, the loss of the stroke sufferer from everyday life~     is a catastrophic event. For the community, the costs of being unable to walk after stroke~     are exorbitant, involving a lifetime of residential care. Therefore, an increase in the~     proportion of stroke patients who regain walking ability will be a significant advance.~      This trial will determine, in patients early after stroke who are unable to walk, whether~     training walking using a treadmill with partial weight support via an overhead harness will~     be more effective than current intervention in (i) establishing more independent walking,~     reducing the time taken to achieve independent walking, and improving the quality of~     independent walking, and (ii) improving walking capacity and participation 6 months later.~   "
258419|NCT00167518|"~     The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe~     and efficacious for patients with clinically significant diabetic macular oedema that is~     recalcitrant to conventional laser therapy~   "
258420|NCT00167505|"~     This study will evaluate the efficacy of two curricula relative to standard care. The first~     is a sexual risk avoidance curriculum for middle school students that included abstinence~     until marriage and complies with Title V Section 510 A-H abstinence education requirements.~     The second is a sexual risk reduction curriculum for middle school students that included~     abstinence and condom/contraceptive information and skills. Each intervention consists of an~     age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in~     7th and 8th grade. The overall goal of the study is to identify common elements of effective~     sexuality education curricula that will be of benefit to youth.~   "
258421|NCT00167492|"~     The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our~     usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to~     find out the effect this change may have on the development of side effects such as relief of~     gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current~     drug) because of these side effects. We will also try to see if improved usage of this drug~     (Myfortic®) will allow us to use lower doses of other medications that lower your immune~     system. We will do some special tests on your blood to see if the amount of the drug is~     related with its effect on the immune system and side effects. Both Cellcept and Myfortic®~     are FDA approved medications although Myfortic® is not approved for use after liver~     transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid)~     but has been coated to prevent breakdown of the drug in the stomach and is made to lower the~     known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.~   "
258422|NCT00167479|"~     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of~     risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid~     lifetime panic disorder or generalized anxiety disorder and current at least moderately~     severe anxiety.~   "
258423|NCT00167466|"~     The effects on indices of gingivitis/periodontitis will differ between study arms in which~     the titanium dioxide semiconductor toothbrush is used, compared to an otherwise identical~     toothbrush with an inert resin core in place of the titanium dioxide semiconductor.~   "
258424|NCT00167453|"~     The research outlined in the BEEP proposal aims to test whether a 12 week exercise program~     alone or combined with a 12 session education program will benefit the physical, emotional~     and social well being of individuals in early to mid stages of Parkinson's Disease compared~     to a Control group and whether these benefits are maintained once the programs are complete~     and over the following 9 months.~   "
258425|NCT00167440|"~     Each year in the United States more than 30,000 children are admitted to intensive care~     units. The majority of these children have some degree of heart instability during their~     stay, yet there is currently no routine way to measure the actual amount of blood that the~     heart pumps. The ability to measure the amount of blood that the heart pumps accurately and~     easily at frequent intervals would be very helpful to the doctor caring for these children~     because many of them have poor heart function as a result of their illnesses. Current~     techniques used in adults to measure output of the heart are either not readily transferred~     to children or demand difficult invasive procedures. Because of this, the amount of blood~     that the heart pumps cannot be measured with enough frequency to help guide care. Despite~     this reality, accurate measurements of the amount of blood that the heart pumps in these~     patients at crucial points in their illnesses would allow for more accurate use of~     potentially harmful procedures and could possibly improve the outlook for these children.~     Likewise, being able to correctly measure blood volume could provide a better way to estimate~     the pressure on the heart and improve treatment.~      The purpose of this research study is to compare the accuracy of doctor estimates of heart~     output, and establish the usefulness of central blood volume measurements by PCOM (pediatric~     cardiac output measurements), a less invasive procedure~   "
258426|NCT00167427|"~     The purpose of the research study is to evaluate an automated, laser-based technique for~     measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.~   "
258427|NCT00167414|"~     The purpose of this study is to evaluate whether radiosurgery, along with standard~     chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and~     immune response), or hormonal therapy, affects the quality and length of life. The standard~     therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second~     purpose of this study is to determine if the levels of a special type of protein (called~     cytokines) found in the blood are related to the quality of life while on this treatment.~   "
258428|NCT00167401|"~     The University of Rochester Cancer Center (URCC) is conducting a research study at Highland~     Hospital and Strong Memorial of lung cancer patients whose tumors cannot be surgically~     removed. The usual treatment for this stage of cancer is chemotherapy (treatment with drugs)~     combined with radiation (chemo-radiation). Because of the risk of spread to other organs,~     patients with your stage of disease are also often treated with additional chemotherapy,~     either before or after the chemo-radiation treatment. The best timing and number of~     treatments for this additional chemotherapy has not been clearly established. The purpose of~     this study is to help determine if a single treatment with two chemotherapy drugs, followed~     by radiation and low-dose chemotherapy is an effective way to treat patients with lung~     cancer. The side effects of this treatment and your quality of life while on the study will~     also be studied. Eighteen will participate in this study locally.~   "
258430|NCT00167375|"~     This study tests a new kind of sleep study in which subjects are awakened 2 times after~     initially going to sleep. The study focuses on the EEG signal process as a person goes to~     sleep. The general hypothesis is that the signal properties are stable from night to night~     during baseline studies, and are different between controls and patients with primary~     insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia~     intervention. Then the new kind of study is repeated in the patients. The controls only are~     examined in baseline studies.~   "
258431|NCT00167362|"~     This study will determine the effectiveness of cognitive enhancement therapy (CET) in~     treating cognitive abnormalities in people experiencing the early stages of schizophrenia.~   "
258432|NCT00167349|"~     The purpose of this study is to determine if a difference exists in the inflammatory response~     which occurs related to coronary artery bypass graft (CABG)surgery performed on~     cardiopulmonary bypass as compared to CABG surgery performed off bypass at the University of~     Pittsburgh Medical Center.~   "
258433|NCT00167336|"~     This study will develop and refine an observational assessment tool called the Personal~     Computer Keyboard Style (PeCKS). When completed this assessment tool will provide researchers~     and clinicians with a valid and reliable method to describe computer keyboarding postures and~     kinematics.~      The proposed study will be divided into two phases. Phase I will be devoted to developing and~     refining an instrument, the Pre-PeCKS, into a valid and reliable data gathering observational~     tool. In Phase II the Pre-PeCKS will be used to develop a predictive model that can~     discriminate between those with and without MSD-UE. The model developed will be used to~     select the construction and weighting of the subscales of the final instrument, the PeCKS.~      Phase I - PeCKS psychometrics - reliability and validity Specific Aim 1: To evaluate inter-~     and intra-rater reliability and the concurrent criterion-related validity of the Pre-PeCKS.~      H.1.1 The Pre-PeCKS will demonstrate acceptable reliability for the following tests:~      H.1.1a. Intra-rater reliability (stability within one rater) H.1.1b. Inter-rater reliability~     (stability across raters) H.1.1c. Test of internal consistency (Cronbach's alpha) (stability~     across items)~      H.1.2 The Pre-PeCKS will demonstrate good concurrent criterion-related validity - Parameters~     selected by raters using the Pre-PeCKS will significantly correlate with biomechanical~     measures (VICON™ motion recording and analysis system and force plate):~      H.1.2.a. Angles and displacements identified by raters using the Pre-PeCKS will correlate~     with angles and displacements measured by the VICON™ motion recording and analysis system;~     H.1.2.b. Number of times spent performing actions as specified by raters using the Pre-PeCKS~     will correlate with number of times measured by a VICON™ motion recording and analysis~     system; H.1.2.c. Level of forceful keying as specified by raters using the Pre-PeCKS will~     correlate with levels of forceful keying measured with a force plate under the keyboard.~      Phase II - PeCKS psychometrics - diagnostic tool development~      Specific Aim 2: To use information gathered using the Pre-PeCKS to develop a diagnostic~     instrument that can identify those with and without MSD-UE. The major hypothesis related to~     Specific Aim 2 is:~      H.2.1. Using information gathered with the Pre-PeCKS and knowing the disease outcome of the~     subjects, predictive models can be developed that discriminate between those who do and do~     not have MSD-UE.~   "
258434|NCT00167323|"~     Effective psychosocial interventions for individuals with an alcohol use disorder~     co-occurring with a severe mental health problem such as bipolar disorder are lacking.~     Treatment engagement, adherence, and retention are a major challenge and crucial to achieving~     a favorable outcome. The early phase of recovery is a key period during which an effective~     intervention exerts its most significant impact. Our proposed treatment intervention is aimed~     at addressing early recovery issues, engagement, and treatment and medication adherence in~     bipolar alcoholics.~      We propose to develop and refine a theoretically based and procedurally specified individual~     adherence therapy intervention for co-occurring alcohol use and bipolar disorder in early~     recovery, to develop standardized procedures, methods, and techniques so that treatment is~     delivered with a high degree of fidelity and competence, and to test the efficacy of this~     intervention through a randomized, parallel-group design comparing this new intervention with~     current regular clinical care.~   "
258435|NCT00167310|"~     The purpose of this study is to determine whether the administration of omega-3~     polyunsaturated fatty acids, particularly eicosapentaenoic acid (EPA), can be useful both to~     reduce coronary artery disease (CAD) risk and illness severity in clinically-stable patients~     with schizophrenia (or schizoaffective disorder), major depression or bipolar disorder~     (depressed phase) being treated with lipid lowering drugs (e.g., statins).~   "
258436|NCT00167297|"~     The purpose of this small open-label trial is to evaluate the feasibility of recruiting~     cannabis dependent patients for treatment with Atomoxetine and MIT. The clinical data to date~     on Atomoxetine has been limited to children and adults with attention deficit disorder~     without co-morbid substance dependence. However, one study estimated that adults with~     attention deficit disorder have rates of drug abuse three to four times higher than controls~     (Mannuzza S 1998). The study also reported that cannabis and cocaine are most frequently~     abused in this population.~   "
258437|NCT00167284|"~     With the advent of managed care, increasing responsibility for the care of patients with~     diabetes is being placed on primary care physicians. Evidence exists that physicians are not~     meeting established practice guidelines, and outcomes in patients with diabetes are less than~     optimal. It is thus the objective of this study to institute a community-based diabetes~     education intervention for both physicians and patients to enhance adherence to guidelines~     and improve patient outcomes.~      We will conduct a chart review (submitted under a separate IRB: #000733) in primary care~     practices to determine health status and guideline adherence. Following the chart review,~     physician practices will be assigned to one of three groups: physician + patient education,~     physician education alone, and usual care. Following the intervention, a repeat chart review~     will be conducted. Pre and posttest comparisons will be conducted to examine changes~     primarily in glycemic control, quality of life, patient knowledge, and physician adherence to~     practice guidelines. Secondarily, we will examine changes in therapeutic intervention, body~     mass index, and barriers to diabetes care. We will also examine individual barriers to~     diabetes care and their influence on outcomes in this population. The last phase of the study~     will encompass a second follow-up visit in which we will examine behavioral factors related~     to clinical change and sustainability of the intervention.~   "
258438|NCT00167271|"~     Body worn sensors and the Internet can be used to self-monitor daily behavior and promote a~     healthier lifestyle in women with fibromyalgia.~   "
258439|NCT00167258|"~     The study will evaluate the effectiveness, economic benefits, and costs of voucher~     reinforcement for cocaine and alcohol abstinence, additional counseling services, and their~     combination in a sample of cocaine dependent patients receiving outpatient treatment as usual~     in a community clinic.~   "
258440|NCT00167245|"~     The primary purpose of this study is to test the effectiveness of topiramate for the~     treatment of combined alcohol and cocaine dependence. Topiramate is approved for the~     treatment of seizures. It has not been proven to be effective for the treatment of alcohol or~     cocaine dependence.~   "
258456|NCT00167024|"~     Primary: to investigate the effects of DNA repair gene polymorphisms on prostate cancer~     susceptibility, pathological grade, disease stage and clinical outcome Secondary: to~     understand the association between DNA repair gene polymorphism and prostate cancer and~     provided important information for screening, prevention and treatment of prostate cancer~   "
258441|NCT00167232|"~     The purpose of this study is to see whether naltrexone is safe and useful in preventing~     alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of~     alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration~     (FDA) for the treatment of alcohol dependence. However, the medication was not approved as~     yet at the dosage we will use in this study. The dosage we will use for the study (150 mg),~     is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike~     other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone~     will not make you sick if you drink alcohol. Rather, people who are taking this medication~     have reported that it helps decrease the pleasure associated with drinking for them. This~     study is being conducted because the medication (Naltrexone) has not been well studied in~     people with both alcohol and cocaine dependence, so it is still investigational.~      We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy,~     this may lead to reduced cocaine use. We are also conducting this study to test two different~     types of psychotherapy as a method for reducing cocaine and alcohol use. One type of~     psychotherapy is designed to help people learn to cope with situations that put them at high~     risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy we will use~     focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on~     developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients~     in the study.~   "
258442|NCT00167219|"~     The investigators hypothesize that long-term disease-free survival (DFS) in patients with~     JMML can be achieved with a treatment of busulfan (BU), cyclophosphamide (CY) and melphalan~     (L-PAM) followed by hematopoietic cell transplantation (HCT).~   "
258443|NCT00167206|"~     The purpose of this study is to determine whether thymic shielding during total body~     irradiation can be given and whether it will reduce the risk of infections in Fanconi Anemia~     patients undergoing alternate donor (not a matched sibling) stem cell transplants.~   "
258444|NCT00167180|"~     The purpose of this study is to test the hypothesis that a pre-infusion preparative regimen~     of cyclophosphamide and fludarabine will improve the effectiveness of DLI in patients with~     blood cancers.~   "
258445|NCT00167167|"~     In this study our hypothesis is that infusion of donor lymphocyte immune cells from the~     subject's bone marrow donor will activate the subject's immune system to attack their cancer.~   "
258446|NCT00167154|"~     The purpose of this trial is to investigate the efficacy of risperidone as an adjunct to an~     antidepressant treatment in the acute management of suicidality during an episode of major~     depressive disorder.~   "
258447|NCT00167141|"~     Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive~     in order to investigate whether there are differences between normal and subnormal men in~     terms of suppressibility, rate of azoospermia and reversibility of suppression of~     spermatogenesis.~   "
258448|NCT00167128|"~     In the management and remediation of students with specific performance deficits in~     speech-in-noise intelligibility, most often, a triad approach for treatment is used, which~     includes direct therapy, compensatory strategies, and environmental modifications.~      The purpose of the study is to determine whether a new hearing aid, the Phonak EduLink-FM~     System, can improve specific performance deficits in speech-in-noise intelligibility.~     Participants will complete a test battery related to auditory processing, as well as some~     psychological tests and questionnaires. One group of participants with specific performance~     deficits in speech-in-noise intelligibility will receive the hearing aid for use in school; a~     second group will not. The effect of this treatment on auditory performance, school~     performance and satisfaction, attention and verbal learning and memory, self concept,~     behavior and listening effort following 26 weeks of hearing aid use will be compared across~     the groups.~   "
258449|NCT00167115|"~     The hypotheses to be tested are 1) the use of alcohol in the form of wine with the evening~     meal will lower plasma glucose during the night and result in lower fasting plasma glucose~     the next morning; 2) the chronic use of alcohol in moderation in the form of wine will have~     beneficial effects on plasma lipids in type 2 diabetic subjects.~   "
258450|NCT00167102|"~     The purpose of this study is to examine prospectively the safety and efficacy of alefacept in~     the treatment of subjects with severe alopecia areata of the scalp. Common features between~     psoriasis and alopecia areata, including immunologic and therapeutic aspects, suggest that~     alefacept, which has been shown to be a safe and statistically significant beneficial~     therapeutic modality for the treatment of psoriasis, may have therapeutic value in alopecia~     areata.~   "
258451|NCT00167089|"~     The purpose of this study is to explore an alternative approach that emphasizes task~     specificity and treadmill training for ambulation training of these patients.~   "
258452|NCT00167076|"~     The purposes of this paper were to determine whether walking speed affected gait parameters~     and force impulse in patients with stroke or not, and if the changes varied in various foot~     regions.~   "
258453|NCT00167063|"~     The purposes of this study are: (1) to investigate the incidence and causes of falls of~     stroke patients residing in Taipei City and Taipei county after their discharge from the~     National Taiwan University Hospital, (2) to investigate the relationship between clinical~     manifestations of stroke patients before their hospital discharge and their incidence of~     falls after hospital discharge, and (3) to identify the risk factors for stroke patients who~     frequently fall after hospital discharge.~   "
258454|NCT00167050|"~     Superior limbic keratoconjunctivitis (SLK) was first described in detail as a clinical entity~     by Frederick Theodore in 1963. The clinical picture of SLK is well documented, but the~     etiology is still unknown. This project will be conducted into through two parts: one is to~     investigate the presentation of chemokine receptors on mast cell and matrix~     metalloproteinases on fibroblasts by immunohistochemistry method from the pathological~     specimens of SLK patients who received conjunctiva resection as the treatment. The other part~     is to investigate the mRNA level of those chemokine receptors via reverse transcription -~     polymerase chain reaction from the conjunctiva collecting form SLK patients.~   "
258455|NCT00167037|"~     The purpose of this study was to compare the balance strategy, as well as center of pressure~     (COP) trajectory and parameters between healthy adults and patients with hemiplegia in~     response to slow- and fast-speed waist- pulling perturbations in forward, left, right, and~     backward directions.~   "
258457|NCT00167011|"~     To test the ability of electron beam CT in evalting the coronary artery pattern in children~     with congenital heart disease.~   "
258458|NCT00166998|"~     Breast cancer can cause focal temperature increase on the breast skin due to vasodilatation~     mediated by NO secretion from cancer cells. Our study is to evaluate this situation and to~     assess the diagnostic efficacy of infrared imaging (thermography)on breast cancer.~   "
258459|NCT00166985|"~     Adenocarcinoma of the endometrium is the fourth most frequent cancer in women. Surgery is the~     treatment of choice in patients with noninvasive or locally advanced disease. The surgical~     technique consists of an exploratory laparotomy, with total hysterectomy, bilateral~     oophorectomy, peritoneal washing, and, in selected high-risk patients, omental and peritoneal~     biopsies and lymphadenectomy. Therefore, preoperative clinical and instrumental staging of~     the local spread of disease, as well as local and distant lymph node involvement, represent a~     critical step in tailoring the extent and the radicalness of surgery.~      The role of angiogenesis in cancer growth and metastasis has been gaining much attention for~     decades. Recent clinical evidence supports this notion. The gradual increase in angiogenesis~     intensity with tumor progression in malignant melanoma has been reported. Abulafia et al.~     reported that increasing angiogenicity could be noted from simple hyperplasia, complex~     hyperplasia, atypical hyperplasia, and Stage IA endometrial carcinoma to invasive endometrial~     carcinoma. The investigators' research team has shown that incremental angiogenesis could be~     demonstrated in the tumorigenesis and the possibility of lymph node metastasis in endometrial~     malignancy. Besides, other growth factors such as vascular endothelial growth factor (VEGF),~     transforming growth factor- (TGF-), IL-6 and IL-8 have also been reported to correlate with~     the angiogenesis and the metastasis of endometrial cancer. It seems that tumor angiogenesis~     of endometrial cancer could be utilized as an important parameter to assess the disease~     severity of the endometrial cancer.~      So, the investigators would like to propose this proposal to focus on the tumor angiogenesis~     in endometrial cancer patients. There are several purposes in this study. First, the~     investigators will evaluate and compare tumor angiogenesis surveyed from functional MRI and~     power Doppler sonography in endometrial cancer patients who receive surgery. Second, the~     investigators will evaluate whether tumor angiogenesis could be a marker to predict the~     disease severity of endometrial cancer. Third, the role of functional magnetic resonance~     imaging (MRI) in endometrial cancer will be elucidated.~   "
258460|NCT00166972|"~     Our study established a model combine the in silico biology and empirical methods to identify~     clinically useful biomarker from information of microarray gene expression profiles in public~     domain. Through this method, we found trophinin as a novel prognostic marker for early stage~     lung cancer, which provide insight towards the process of cancer metastasis and the potential~     target for treatment.~   "
258461|NCT00166959|"~     The purposes of this study are to investigate the reliability and validity of the modified~     Postural Assessment Scale for Stroke Patients (mPASS) and its applications in early detection~     of fall-prone patients.~      The intraclass correlation coefficient will be used to examine the intra-rater reliability,~     inter-rater reliability, and the Cronbach’s alpha will be used to examine the internal~     consistency of the 16 items of mPASS.~   "
258462|NCT00166946|"~     We popose that arsenic-induced lymphocytes dysfunction plays an important role in biological~     mechanisms of arsenical Bowen’s disease.~   "
258463|NCT00166933|"~     There is no previous study on the minimal erythema dose of UVB irradiation in Chinese people.~     We will investigate the correlation of skin phototype, constitutive skin color, facultative~     skin color and minimal erythema dose in Taiwanese.~   "
258464|NCT00166920|"~     All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical~     Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D~     single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility~     contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen~     utilization were calculated and plotted in all subjects.~   "
258465|NCT00166907|"~     The specific aims of this research are delineated as the following: Aim 1: To investigate the~     neuromuscular and biomechanical mechanisms of the emerging processes of proactive and~     reactive balance control during sitting and standing in patients with stroke at different~     stages of the recovery course. Aim 2: To determine the relationships between brain lesion~     sites and the recovery patterns of reactive and proactive balance control mechanisms in~     patients with stroke. Aim 3: To determine the relationships between the impairments in~     reactive and proactive balance control mechanisms and functional outcome as well as fall~     incidence in patients following stroke. Aim 4: To investigate the efficacy of different~     training regimens in improving reactive and proactive balance control strategies and in~     preventing falls in stroke patients with different brain lesion sites. Principally, three~     hypotheses are to be tested: Hypothesis 1:The emerging processes and recovery patternes of~     proactive and reactive balance control may be different among stroke patients with different~     brain lesion locations. Hypothesis 2:There are positive correlations between the level of~     impairments in reactive and proactive balance control mechanisms and functional outcome as~     well as fall incidence in patients following stroke. Hypothesis 3:Training regimens that~     could best facilitate the emergence or improvement in reactive and proactive balance control~     strategies are different.~   "
258466|NCT00166894|"~     The aim of this trial is to evaluate the level of TREM-1 in different kinds of pleural~     effusion.~   "
258467|NCT00166881|"~     In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~~     60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for~     patients with non-resectable gastric cancer. For those patients who have achieved complete~     response (CR) or partial response (PR), DI will be used to consolidate the remission. For~     those patients who fail to achieve remission by P-HDFL, DI will be used as salvage~     chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in~     this prospective study.~   "
258468|NCT00166868|"~     Abstract~      Biliary atresia (BA) is an idiopathic, progressive, and fatal disease if untreated. Since~     Kasai first introduced the operation for BA in 1959, there have been encouraging results in~     treating this disease. Ascending cholangitis is a frequent and often recurrent complication.~     It may worsen the prognosis, with an increase in mortality, secondary failure of restoration~     of bile flow, and possible exacerbation of portal hypertension. For patients who have had~     restoration of bile flow with a timely portoenterostomy, the recurrence of ascending~     cholangitis is the single most significant variable pertaining to long-term prognosis.~     Patients with multiple episodes of ascending cholangitis are more likely to require liver~     transplantation than those without multiple recurrences. Therefore, the prevention of~     cholangitis is crucial in the management of patients who have had a Kasai portoenterostomy.~      Some oral antibiotics, like trimethoprim-sulfamethoxazole (TMP/SMZ) and neomycin have showed~     the effect to prevent against ascending cholangitis. But, we should consider the problem of~     drug resistance after long-term use of antibiotics. Is there any better and safer treatment?~     Probiotics are live microorganisms, which have beneficial effects on human health. Many~     studies have showed that probiotics have effects to treat or prevent intestinal infection or~     inflammation even for patient after liver transplantation. The aim of this study is to~     investigate the possibility of use of probiotics in prophylaxis of ascending cholangitis.~      We want to enroll 20 BA patients aged 0 to 3 years, who had a Kasai operation. Ten patients~     are treated with neomycin (25 mg/kg/d, qid, 4 days a week). Another 10 patients receive~     Lactobacillus casei rhamnosus, Lcr 35 (8x108 CFU/day, bid) The duration of treatment is 6~     months. Bacterial cultures of stool are performed before treatment and 1 month, 3 months and~     6 months after treatment to evaluate the change of intestinal flora. Another 10 BA patients,~     from 1991 to 1996, aged 0 to 3 years, without prophylaxis after portoenterostomy, were served~     as the historical control group. Comparisons of the episodes of cholangitis, time to the~     first episode, and body weight change are made among the three groups.~   "
258469|NCT00166855|"~     Background: Multiple myeloma (MM) is a clonal plasma cell neoplasm characterized by~     proliferation of neoplastic plasma cells in bone marrow (BM). So far, it is an incurable~     disease and the median survival time of MM patients is only three to four years. Till now,~     whether the extent of angiogenesis in BM of MM patients serves as an important and~     independent prognostic factor is still debated. In this study, we would like to have the BM~     perfusion status imaged by dynamic MRI to mimic the macroscopic vascular densities of BM, and~     thereafter, the BM perfusion status, the clinical outcome of the MM patients, and the~     angiogenesis related biological markers will be correlated.~      Methods: About 35 to 50 MM patients, included newly diagnosed patients or the patients who~     will undertake the special treatment, are enrolled in this study. The thoraco-lumbar spine is~     scanned by the MRI, and the BM perfusion status is obtained by contrast-enhanced dynamic MRI.~     Meanwhile, the patients undertake BM biopsy at one site or two sites and the BM aspirates are~     also obtained and separated into BM plasma and BM mononuclear cells (BMMC) by Ficoll-Hypaque~     centrifugation. The angiogenesis related genes expression profiles of the BMMC will be~     determined by cDNA microarrays and some of them, like VEGF, bFGF, and PDGF, will be~     semiquantified by real-time PCR. The levels of related proteins will be determined by ELISA.~     The BM plasma samples are further applied to proteomic analysis to screen the novel molecules~     with clinical relevance.~      Prospects: BM perfusion patterns imaged by dynamic MRI can predict the clinical outcome of~     MM, and are correlated with the angiogenesis relevant biological markers in BM.~   "
258470|NCT00166842|"~     The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in~     different regimens in newly renal transplant patients, and the effect of dosage form~     conversion on the concentration of sirolimus in stable renal transplant patients. So that we~     can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.~   "
258471|NCT00166829|"~     The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is~     influenced by the concurrent use of sirolimus.~   "
258472|NCT00166816|"~     The purpose of this study is to understand the pharmacokinetic of sirolimus in different~     regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design~     the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose~     regimen for Taiwanese.~   "
258473|NCT00166803|"~     Cardiovascular events are the leading cause of death in developed countries worldwide,~     including Taiwan. The disruption of atherosclerotic plaques and the subsequent formation of~     thrombi are currently recognized as the major cause of morbidity and mortality of~     cardiovascular diseases. Therefore, early detection of vulnerable plaques is clinically~     important for risk stratification and also to provide early treatment. Several imaging~     approaches have been adapted to detect vulnerable plaques, however, most of them are based on~     morphologic characteristics of atheroma. We hypothesize that PPARγ-induced plaque regression~     could be monitored clinically by use of 18FDG PET/CT approach, which could assess the~     inflammatory activity, and can be detected noninvasively earlier than previously reported.~   "
258474|NCT00166790|"~     We will try to use the novel analytical technique -Dual Polarisation Interferometry (DPI),to~     achieve detection the minimal amount of the human chorionic gonadotropin for early detection~     and strict monitor of the GTD.~   "
258475|NCT00166777|"~     Quadriceps retraining, especially the vastus medialis oblique muscle strengthening, plays an~     important role in clinical management of patellofemoral pain syndrome. Vastus medialis~     oblique muscle roles as a dynamic stabilizer during the functional knee movement. It can~     generate a medial pulling force to patella against the lateral pulled by vastus lateralis.~     Thus it improves the patellofemoral joint compression force, reduces the knee pain, increases~     functional abilities, and patients’ quality of life.~      Could vastus medialis oblique be isolation by way of specific exercise without or minimize~     the recruitment of vastus lateralis？ According to human anatomy, vastus medialis oblique~     muscle origin from hip adductor magnus tendon, thus if incorporate hip adduction with knee~     extension as a selective means of training needs more researches. However, literature search~     shows that there are only a lot of EMG studies, so we need further clinical research to prove~     the treatment effect of this kind of strategy.~      The purpose of the study is to investigate the treatment effects of hip adduction combine~     knee extension exercise in patients with patellofemoral pain syndrome. We use muscle~     morphology of quadriceps muscle, pain, and functional abilities as the main outcome measures.~     Besides, we will make further compare with traditional knee extension exercise. The first~     hypothesis of the study is that patients with patellofemoral pain syndrome will get~     improvement in muscle morphology of quadriceps muscle, pain, and functional abilities after~     hip adduction combine knee extension exercise training . The second hypothesis is that~     patients with patellofemoral pain syndrome who receive hip adduction combine knee extension~     exercise training will get more improvement in muscle morphology of quadriceps muscle, pain,~     and functional abilities than patients who receive traditional knee extension exercise~     training.~      90 patients with patellofemoral pain syndrome who less than 50 years old will be included in~     this study, and randomly distributed to hip adduction combine knee extension exercise group,~     knee extension exercise group, and control group. Following 8 weeks exercise training by an~     experimental physical therapist, ultrasound measurement of muscle thickness and~     cross-sectional area of vastus medialis oblique muscle, vastus lateralis muscle, and rectus~     femoris muscle component of quadriceps, 10cm-VAS patellofemoral joint pain evaluation,~     including VAS-U, VAS-W, and VAS-activity, and Lysholm scale scores will be measured. A~     two-way mixed ANOVA will be used to compare the mean differences between theses three groups.~      The study is aimed to provide an clinical evidence for evidence-based practice of~     rehabilitation in patients with patellofemoral pain syndrome.~   "
258476|NCT00166764|"~     Psychiatric patients under the mental impaired influences, their living function were~     disabled, and their social lives were handicapped consequently. Idea psychiatric treatment is~     to control the psychiatric symptoms in a better way, to develop efficient psychiatric~     adjustment, to manage living stress into a lower level, to gradually develop the meaning and~     value of the patients’ lives, and to obtain the satisfaction and happiness in life for them.~     In order to investigate the satisfaction for psychiatric patients under the current treatment~     and to evaluate their psychiatric health, it is necessary to measure the mental health status~     for the psychiatric patients, and to ensure the ideological status of psychiatric treatment.~     If there is a mental health measurement for the psychiatric patients, we may precisely~     identify the mental health levels of the patients and their mental disturbances degrees.~     Accordingly, we may develop efficient procedure to manage the mental health for the~     psychiatric patients, and to achieve the goal for the idea psychiatric treatment.~      In this study, we established the mental health assessment data sheet according to the~     clinical experiences. It includes mental health index data sheet, mental-and-physical stress~     response data sheet, mental sustentation data sheet, and supplemented with a general living~     satisfaction assessment data sheet. We will evaluate the reliability and validity of this~     study to ensure the usability of these data sheet in clinics. We will also recruit the~     continuous treated and mentally stabilized patients as subjects. After obtaining their~     written informed consents, we will go through these mental health assessments to discover the~     mental health status of these psychiatric patients, and use it as a reference to develop idea~     psychiatric treatment. We will use ICC test for the repeated measurement validity, Pearson r~     correlation coefficient within our data analyses to evaluate the validity of the same~     measurement, and independent t-test to assess the differences between the patient group and~     the society group (from previously established data files). This study result may evaluate~     the possible deficits existing in the traditional psychiatric treatment and may be used as a~     reference for the development of idea psychiatric medicine.~   "
258484|NCT00166660|"~     The goal of the project is to show the effectiveness of individualized developmental care and~     intervention, which begins with the FGR preterm infant's admission to the newborn intensive~     care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA~     (corrected age for prematurity).~   "
258485|NCT00166647|"~     The purpose of the study is to determine the frequency of allelic variants in TPMT in the~     Hispanic population and to compare the frequency in the Hispanic population with the~     Caucasian Population.~   "
258486|NCT00166634|"~     The primary objective of this proposal is to demonstrate that ABPM can be used to improve~     study design for interventional trials in children with hypertension.~   "
260148|NCT00144547|"~     This is an open-label, extension, Phase III study to evaluate the long-term safety and~     efficacy of MRA in patients with RA who participated in Study MRA012JP.~   "
258477|NCT00166751|"~     Ultrasonographic examination has long been used to assess the swallowing function. It has the~     advantages of no ionizing radiation on examination and the possibility of using the real food~     instead of the barium meal in testing. Thus, the subjects can be examined repeatedly and in a~     more physiological status of swallowing. However, the ultrasonographic examination is only~     used in assessing the oral phase of swallowing. It can accurately visualize the tongue~     movement, measure the oral transit time of bolus, and sometimes the hypoid bone motion, but~     has not been applied on the evaluation of pharyngeal phase of swallowing. Physically,~     laryngeal elevation is an essential component of the swallowing movement on pharyngeal phase.~     It ensures the occlusion of airway and opening of criopharymgeus muscle, and thus prevents~     the aspiration. To evaluate the laryngeal elevation is crucial point in managing the~     dysphagic patients.~      The purpose of this project is to measure the laryngeal elevation in normal and in dysphagic~     patients with cerebrovascular (CVA) accident using ultrasonographic techniques. This work~     will include four group subjects. The first group consists of 20 young subjects (< 40 years);~     the second group consists of 20 age-matched normal subjects; the third group consists of 20~     CVA patients without swallowing problems, and the fourth group consists of 20 CVA patients~     with dysphagia, which was proven by VFSS. The laryngeal elevation is detected by ultrasound~     with the transducer placing between the hyoid bone and thyroid cartilage. The two markers are~     easily detected on sonogram because of the presence of acoustic shadow, a specific character~     of bony structure on sonogram. The distance between the hyoid bone and thyroid cartilage~     before and during swallowing is measures and compared among the groups. The distance change~     of the patients with dysphagia is further compared with that defined by VFSS. With the result~     of this study, we will understand the status of laryngeal elevation during swallowing in~     normal and dysphagic subjects, and further determine the accuracy of ultrasonographic~     measurement in measuring the laryngeal elevation. With this knowledge, we might extend the~     usage of ultrasonographic examination on evaluating swallowing function.~   "
258478|NCT00166738|"~     Persons with schizophrenia experience imaginary voices, visions and disorganized thoughts,~     and are handicapped when it comes to social life, which is detrimental to the affected~     individuals and the community. Although the pathogenesis of this mental disease has not been~     clearly elucidated, much evidence suggests that inheritance is of major etiological~     importance and multiple genetic components are implicated. Previous linkage studies of~     familial schizophrenia have led to the successful identification of numerous susceptibility~     loci covering many of the human chromosomes, including chromosome 1q, 5q, 6p22, 6p24, 8q21,~     13q32, 15q13-14 and 22q11, etc. Necessities for further identification of candidate genes~     involved in familial schizophrenia by taking a genome-wide approach are listed as follows:~        1. given that multiple genes are responsible for this disease, it is of critical interest~          to view the complete molecular profiling of schizophrenia's genome;~        2. identification of promising schizophrenia candidate genes by genome-wide scanning will~          facilitate the development of molecular markers and provide a more objective and~          effective assessment method in psychotic diagnosis and prognosis;~        3. prevention of the onset of this disorder will be improved by early classification of~          individuals bearing strong genetic loading for schizophrenia as a high risk population;~        4. making a breakthrough into the investigation of schizophrenia pathogenesis by the~          characterization of susceptible genes found by genome-wide exploring.~      Array-based comparative genomic hybridization (CGH) allows high-throughput genome-wide survey~     for DNA copy number aberrations, providing a powerful tool for investigating genetic~     disorders and for developing diagnostic and therapeutic targets. Arrays used in this study~     consist of approximately 43,000 60-mer oligonucleotide probes that span coding and noncoding~     regions of the whole human genome with an average spatial resolution of around 35 kb.~     Furthermore, the sensitivity of these arrays is capable of detecting and mapping regions of~     single-copy losses, homozygous deletions, and amplicons of various sizes even when using~     full-complexity genomic samples. In this study, the investigators will conduct an array-based~     comparative genomic hybridization (CGH) with genomic DNA of many affected members from~     schizophrenia families (the investigators classified families according to the presence or~     absence of two or more affected members) to identify a set of candidate genes associated with~     this disease. It is hoped that the results obtained from this study will improve the accuracy~     and efficiency of psychotic treatment.~   "
258479|NCT00166725|"~     The present study will provide information on whether the somatostatin analog, octreotide~     acetate, could have an inhibitory effect on circulating chromogranin A. The demonstration of~     an antisecretory effect of somatostatin analogs could offer a rationale for a large scale~     randomized study.~   "
258480|NCT00166712|"~     This is an open label, single-center, randomized phase IV pilot study of steroid and~     calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two~     doses of alemtuzumab to achieve peripheral T-cell depletion. Intravenous glucocorticoids will~     be administered prior to alemtuzumab administration to limit cytokine release syndrome in~     association with this monoclonal antibody, and continued for the first two days~     post-transplant. Thereafter, steroids will not be used for immunosuppression. All transplant~     recipients will be started on oral immunosuppressive therapy with mycophenolate mofetil (MMF)~     prior to transplant. Pretransplant, these patients will be randomized to receive, in~     addition, either tacrolimus (Tac) or sirolimus.~      After six months, patients in the tacrolimus arm who do not experience rejection will be~     randomized to continue on tacrolimus or to be converted to the combination of sirolimus and~     MMF. Individuals in this arm of the study who do not experience acute rejection, and~     demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant (those~     staying on Tac + MMF) or 3 months post-conversion (those converted from Tac + MMF to~     sirolimus + MMF) will be weaned to MMF monotherapy.~      Individuals in the sirolimus + MMF arm who do not experience acute rejection and demonstrate~     evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to~     MMF monotherapy.~   "
258481|NCT00166699|"~     The study will establish whether the use of ultrasound scanning with a purpose built probe~     will aid the insertion of the needles for epidural and spinal anaesthesia for obese women~     undergoing elective caesarean section The study group will be 46 obese women (defined by the~     ratio of height to weight) at time of initial booking ultrasound scan, undergoing routine~     caesarean section with no serious illnesses that are both willing and able to provide~     informed consent prior to spinal epidural anaesthesia. Patients will be excluded if they have~     signs or symptoms of systemic or local infection, if they have a history of previous spinal~     surgery, a blood clotting abnormities.~      In order to evaluate the clinical usefulness of the ultrasound probe a randomised comparison~     of the traditional clinical methods of feeling the bones of the spine and ultrasound guided~     insertion of a combined spinal epidural anaesthetic will be undertaken. The rodiera tiped~     17/18G 90mm tuohy needle and 123mm 27G spinal needle manufactured by Sarstedt will be the~     regional needles used for the combined spinal epidural anaesthetic. Randomisation into two~     groups (ultrasound guided needle insertion and feeling the bones) will be by computer~     generated random sequence. This information will be recorded in sealed envelopes and placed~     in the ward. Patients who meet the inclusion criteria and who consent immediately prior to~     caesarean section will be sequentially assigned a number that will correspond to a sealed~     envelope. The main aim of the study will be to detect any difference in time taken to insert~     epidural catheter via the needle in the patients back. The other factors measured will be the~     number of times the skin is punctured and bone touched by the needle, number of conversions~     from regional (spinal epidural) to general anaesthesia, patient satisfaction scores,~     requirement for extra local anaesthetic following initial blockade during Caesarean section.~      The factors will be compared by student t-test using Statistica6 (StatSoft,Inc.(2001).~     STATISTICA (data analysis software system), version 6. www.statsoft.com). A population of 46~     patients will be required assuming a mean time for inserting a combined spinal epidural~     without~   "
258482|NCT00166686|"~     The goals of the study are to determine the efficacy of clonidine in the treatment of~     children with neurocognitive sequelae following the therapy of long term malignancies. In~     addition, the study hopes to determine the long-term effect of clonidine on children's~     academic and psychosocial function.~   "
258483|NCT00166673|"~     This study is being done to find out how accurate the Navigator continuous glucose monitor is~     in children. It is also being done to see if use of the Navigator can improve blood sugar~     control and help prevent low blood sugar events. This study has three basic parts: Use of the~     Navigator at home for one week without being able to see the blood sugar readings; a Baseline~     visit or a 24-hour admission to a research unit of the hospital to find out how well the~     Navigator measures the blood sugar; and then 3 months use of the Navigator at home as an aid~     to diabetes care.~   "
258528|NCT00166075|"~     Using a touch screen computer, the researchers are screening emergency department patients~     for intimate partner violence and mental health issues.~   "
258487|NCT00166621|"~     The purpose of this study is to determine the efficacy, safety, and population~     pharmacokinetics and determinants of drug responses to buspirone in children with autism~     using a randomized, double blind, cross over study in children ages 2 to 6 years.~   "
258488|NCT00166608|"~     Genotyping assays for polymorphisms in the interleukin 10(IL10)gene and the inducible nitric~     oxide synthase (iNOS) gene will be performed. Genotypes will be compared to the severity of~     toxicity following overdose.~   "
258489|NCT00166595|"~     The purpose of this study is to determine if the known differences in genes influence drug~     metabolizing enzymes and receptors that are involved in risperidone drug action. The study~     will determine if differences in these genes will change the concentration of risperidone in~     the blood over time in children in relation to side effects and clinical response to~     risperidone.~   "
258490|NCT00166582|"~     The purpose of this research study is to examine the effectiveness of a parent-youth teamwork~     treatment and an asthma education treatment in helping children use their asthma medicines~     correctly. We also want to learn about how these treatments affect parental involvement in~     asthma care, parent and youth relationships, and children’s health care.~   "
258491|NCT00166569|"~     The goal of this study is to determine the genetic basis of polycystic ovary syndrome (PCOS).~     We will first look for genes in the Icelandic population, where large family trees are known~     and it is easier to search for genes. We will then determine whether these same genes are~     important in U.S. PCOS patients.~   "
258492|NCT00166556|"~     This is a prospective, multicenter open-label single arm trial in which recipients of liver~     allograft will receive uniform immunosuppressive induction and maintenance regimens.~     Participants with end stage liver disease who meets the entry criteria will be consented and~     enrolled.~      Participants receive Campath-1H and maintenance immunosuppression with tacrolimus therapy.~     After one year of tacrolimus therapy, an assessment of the immunologic status including blood~     gene expression and geno-race studies will be performed which will include studies on the~     liver graft biopsy. At this time, patients will be selected to undergo immunosuppressive~     withdrawal. This will be made on an individual basis with definitive inclusion and exclusion~     criteria.~      The objectives of the study are to evaluate the safety and efficacy of immunosuppressive~     regimens comprising Campath-1H induction followed by maintenance immunosuppressive therapy~     with tacrolimus on allograft survival. However, secondary objectives will be to assess~     withdrawing tacrolimus after Campath-1H induction in an immune depletion and subsequent~     immune reconstitution. This study will evaluate whether a combination of anti-rejection~     medications (Campath-1H and tacrolimus) can prevent rejection and allow the body to develop~     tolerance to the transplanted liver.~   "
258493|NCT00166543|"~     This study is being done to find out how safe TAS-108 is and how well TAS-108 works on~     recurrent or recurrent inoperable breast cancer.~   "
258494|NCT00166530|"~     In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L~     on a stable (> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg),~     investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg~     simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus~     simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their~     LDL-C treatment goal with the combination tablet compared to doubling the starting dose.~     Furthermore, the effect of both treatment regimens on other lipid parameters, safety and~     LDL-subfractions will be measured.~   "
258495|NCT00166517|"~     Immunogenicity and Safety of V260 in Healthy Infants in Korea~   "
258496|NCT00166504|"~     This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to~     atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in~     Korea. The primary hypothesis being tested is that daily administration of Vytorin will~     result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration~     from baseline after 6 weeks treatment compared to atorvastatin.~   "
258497|NCT00166491|"~     The purpose of this study is to determine if there is any difference between two ways of~     controlling blood sugar with insulin. In patients admitted to the intensive care unit, blood~     sugar levels often rise due to the stress of illness or surgery. Studies have shown that~     patients do better if their blood sugar is kept normal. In order to maintain normal blood~     sugar levels, the investigators often give insulin (a substance made by the body), and they~     decide how much to give based on how high the blood sugar is. This study will compare two~     different ways of deciding how much insulin to give and compare how well each method keeps~     the blood sugar in a normal range. Both ways of controlling blood sugar are~     institutionally-approved protocols and part of routine care.~   "
258498|NCT00166478|"~     This trial will compare no treatment to exisulind therapy. Patients enrolled on the treatment~     arm will begin treatment 4 weeks prior to the scheduled date of surgical removal of the~     prostate and will take 375 mg by mouth daily for the 4 weeks prior to radical prostatectomy.~     Participants will be followed for total of 2 months from the time of starting study drug.~   "
258499|NCT00166465|"~     Phase I: The primary objective of the Phase 1 portion of this study is to determine the~     Maximum tolerated dose and the recommended Phase 2 dose of ALIMTA plus oxaliplatin when given~     with folate and vitamin B-12 supplementation in the treatment of patients with unresectable,~     locally advanced or metastatic colorectal cancer. The Phase I component of the study will be~     activated for enrollment of Mayo Clinic patients only.~      Phase II: The primary objective of the Phase 2 portion of this study is to determine the~     tumor response rates to ALIMTA plus oxaliplatin and oxaliplatin plus 5-fluorouracil and~     leucovorin in patients with locally advanced unresectable or Stage IV colorectal cancer that~     have not received prior chemotherapy for advanced disease. Patients will be randomly assigned~     to receive either ALIMTA plus oxaliplatin (Arm A) or Oxaliplatin plus 5-Fluorouracil and~     Leucovorin (Arm B). The Phase II component of the study will be activated for enrollment of~     patients via the Mayo Clinic Cancer Research Consortium mechanism. A comparison will be made~     of the side effects between regimens.~   "
258500|NCT00166452|"~     The purpose of this study is to determine if lenalidomide is a safe and effective treatment~     for complex regional pain syndrome type 1 (CRPS).~   "
258501|NCT00166439|"~     The goals of this protocol are to determine the effect of oxaliplatin, cytosine arabinoside,~     and dexamethasone with Rituxan (ROAD) as treatment for patients with relapsed CD20+ B-cell~     non-Hodgkins lymphoma (NHL).~   "
258502|NCT00166426|"~     This is a study in which patients with prostate cancer treated by surgical removal of the~     prostate and considered to be at risk for prostate cancer recurrence will receive Exisulind~     250 mg twice a day or placebo twice a day for two years.~   "
258503|NCT00166413|"~     Patients with primary systemic amyloidosis will be treated with CC-5013 (lenalidomide;~     Revlimid) as a single agent for 3 months. If their disease worsens or does not improve during~     that time frame dexamethasone will be added to the treatment program.~   "
258504|NCT00166400|"~     Mitral valve regurgitation (leakage of the mitral valve of the heart) is frequent and~     currently there is no specific medical therapy. Mitral regurgitation is a slowly progressive~     disease that frequently requires surgical treatment. This randomized clinical trial will use~     Metoprolol, a common beta-blocker medication, to determine if medical treatment impacts~     mitral valve disease progression.~   "
258505|NCT00166387|"~     Several non-genetic and genetic factors that could influence the risk of inhibitor~     development in hemophilia A have been discussed but not fully explored. The aim of the HIGS~     is to identify these genetic factors.~   "
258506|NCT00166374|"~     Patients with vertebral compression fracture will be treated cement injection into the spine~     and monitored using standard evaluations.~   "
258507|NCT00166361|"~     The purpose of this study is to evaluate the safety and efficacy of the Memokath 051 ureteral~     stent as a long-term temporary and minimally invasive means of providing ureteral drainage in~     the setting of malignant extrinsic ureteral obstruction secondary to inoperable abdominal or~     pelvic malignancies. Up to 15 adults who have extrinsic ureteral obstruction secondary to an~     inoperable abdominal or pelvic malignancy and need ureteral stent drainage will undergo~     outpatient placement of the ureteral stent. Ongoing monitoring will continue for as long as~     the stent is in place.~   "
258508|NCT00166348|"~     The purpose of this study is to determine whether there is benefit from providing cognitive~     rehabilitation in the group setting. Several standardized tools will be used to measure~     progress when a participant enters the group, leaves the group and at a one year follow-up.~   "
258509|NCT00166322|"~     This study is an investigation of the dopaminergic neurotransmission in patients with~     schizophrenia, patients at risk for the development of schizophrenia, and healthy controls~     using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging~     technique under amphetamine challenge.~   "
258510|NCT00166309|"~     FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate~     and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the~     treatment of joint hemorrhages in subjects with severe hemophilia A and inhibitors. The study~     is designed as a clinical equivalency trial.~   "
258511|NCT00166296|"~     The purpose of this study is to determine whether the use of an antidepressant (escitalopram)~     can prevent depressive episodes that appear during the treatment with peg-interferon and~     ribavirin in patients with chronic hepatitis C.~   "
258512|NCT00166283|"~     The current study is a double-blind, placebo-control randomized clinical trial examining the~     efficacy of memory retraining in Multiple Sclerosis (MS). Impairment in higher level~     cognitive processing, such as new learning and memory, is one of the most common deficits in~     individuals with MS and such deficits have been shown to exert significant negative impact on~     multiple aspects of everyday life, including occupational and social functioning. Despite~     these findings, few studies have attempted to treat these cognitive deficits in order to~     improve the everyday functioning of individuals with MS. Through a small randomized clinical~     trial, we found that individuals with MS with documented memory impairment show a significant~     improvement in their memory performance following a treatment protocol designed to facilitate~     learning. The current proposal will replicate this finding and further evaluate (a) the~     impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment~     and (c) the utility of booster sessions in facilitating long-term treatment effects. We will~     randomly assign individuals with MS, with documented impairment in new learning abilities, to~     a memory retraining group or a placebo control group. Both groups will undergo baseline,~     immediate and long-term follow-up assessment consisting of: (1) a traditional~     neuropsychological battery and (2) an assessment of global functioning examining the impact~     of the treatment on daily activities. This design will allow us to evaluate the efficacy of~     this particular memory retraining technique in an MS population through the assessment of~     cognitive function via a standard evaluation. In addition, we will be able to draw~     conclusions regarding the impact of this particular memory remediation program on everyday~     life from questionnaires completed by the participant and a significant other. Optional~     enrollment in pre- post neuroimaging will also allow us to look at changes in the brain.~   "
258513|NCT00166270|"~     This is a prospective, nonrandomized, multi-center study to evaluate the safety and~     effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated~     and then followed for 36 months to evaluate the change in their fibroid symptoms.~   "
258514|NCT00166257|"~     The purpose of this study is to compare two treatments strategies to prevent further attacks~     in patients who have suffered an stroke or occlusion of a major artery with no obvious reason~     other than a persistent small opening between the upper heart chambers~   "
258515|NCT00166244|"~     Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared~     with fixed dosing in de novo MMF treated renal transplant recipients with respect to the~     incidence of treatment failure.~   "
258516|NCT00166231|"~     The causes of pediatric pain are often not the same for every child. Most children who visit~     a cardiology specialist with complaints of chest or other somatic pain have no known medical~     diagnosis to explain their symptoms. These children and their families often leave with no~     explanation for the child's distress.~      This early study will ask parents and children specific questions related to the stress in~     their lives, their emotional well-being and the children's physical functioning. The~     investigators want children who experience chest and other somatic pain, and those who do~     not, to be in their study so that they can look at both groups.~      The investigators hope to use these answers to better inform cardiologists who often work~     with children with non-cardiac pain and, in turn, help them to better serve their patients.~     Ultimately, the investigators hope that the answers they get will provide answers to these~     families. They also hope to use the results of this study to put together a short screener~     for the cardiologist to give to pediatric patients with complaints of chest or other somatic~     pain to help the cardiologists better understand their patients' symptoms.~   "
258529|NCT00166062|"~     The purpose of this study is to see if using a computer kiosk to screen men and women for~     intimate partner violence victimization and perpetration is safe and effective. We~     hypothesize that screening will not result in any adverse events.~   "
258601|NCT00165074|"~     The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7~     to 10 days of life time will improve lung function in premature infants, allowing a decrease~     in required oxygen concentration and ventilator settings.~   "
258517|NCT00166218|"~     The normal heart has four chambers. There are two upper (or filling) chambers and are called~     the atrium. There are two lower (or pumping) chambers and are called the ventricles. One of~     the ventricles pumps blood to the lungs to get oxygen. This oxygenated blood is returned to~     the heart then pumped to the rest of the body by the other ventricle.~      Sometimes babies are born with heart defects that only allow one of the lower chambers~     (ventricle) to work properly. This means that the one ventricle must pump blood to both the~     lungs and to the rest of the body. Babies born with this defect must undergo multiple~     surgeries, the first of which is usually done during their first week of life.~      There is a machine that is FDA approved that can measure how much oxygen is delivered to the~     brain. This non-invasive (outside the body) machine uses Near-infrared spectroscopy (NIRS),~     which is similar technology used in pulse oximetry and is routinely used to measure the level~     of oxygen in blood. At Children's Healthcare of Atlanta, we typically place the NIRS machine~     on the baby in the Cardiac Intensive Care Unit immediately after their first surgery to~     monitor oxygen delivery to the brain. The monitor has proven to be accurate in this~     situation.~      We now want to know if we can use this monitor to assess oxygen delivery to the brain before~     and during a routine heart catheterization prior to the child's second surgery. Once consent~     is obtained, we will place a probe on the child's forehead during the pre-catheterization~     visit and obtain readings for 5 minutes. The probes are about the size of a quarter and are~     self-stick (they look like the kind of leads used to measure the babies heart rate [EKG]).~     The machine will be disconnected for the rest of the Pre-catheterization visit, however the~     probes will stay on the child's forehead. Once the child is in the catheterization suite, the~     machine will be reconnected. A sheath or hollow tube is routinely placed in a blood vessel in~     the child's neck or groin for the catheterization. The doctor would place a special catheter~     in this sheath that measures oxygen levels in blood continuously. This monitor would be~     calibrated by using the results of a blood sample that is routinely drawn from the child's~     IV. During the same sampling, an additional 2cc's of blood would be collected to measure the~     lactate level. The lactate level is an indicator of how well the child is using oxygen. Once~     this monitor is calibrated, data will be collected for 5 minutes to compare it with the NIRS~     machine. The special catheter will be removed after the 5-minute time period, and the~     catheterization will proceed as usual. The NIRS probes will stay on the child's forehead~     during the entire catheterization with the data documented. At the end of the~     catheterization, the probes will be removed.~   "
258518|NCT00166205|"~     The purpose of this study is to determine whether the Swedish Adjustable Gastric Band (SAGB)~     is safe, and effective in achieving weight loss in patients with Morbid Obesity.~   "
258519|NCT00166192|"~     Melasma is an acquired discoloration of the skin characterized by brown patches. Chemical~     peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly~     used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a~     short period. The skin will peel similar to a sunburn, and moisturizers are applied to the~     skin. Although both agents are well-accepted, there have been no good comparisons of the two~     agents. The purpose of this study is determine if there is a difference in the effectiveness~     of these two agents.~   "
258520|NCT00166179|"~     The purpose of this study is to compare cardiac MRI with positron emission tomography (PET)~     with fluorodeoxyglucose (FDG) to determine if cardiac MRI images are as good as, or better,~     than PET with FDG.~   "
258521|NCT00166166|"~     The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor~     (EDHF) plays in dilating blood vessels and whether it differs between healthy people and~     those with high cholesterol. A second purpose of the study is to determine the identity of~     EDHF.~   "
258522|NCT00166153|"~     The survival of children who have received heart transplants has greatly improved over the~     last ten years. One reason for this is better control over rejection. Rejection medications~     require a delicate balance of enough medicine to work without causing side effects. It is a~     goal to avoid both rejection and side effects from the anti-rejection medicines. Usually~     several medicines are used together to prevent rejection. One of these medicines is often~     Mycophenolic Acid or CellceptThis medicine has been used longer for adults than is has for~     children. More information is needed on using it for children. The dose is usually determined~     by the patient's weight or body surface area.~      There have been some early studies of the use of Cellcept, but none have proven a~     relationship between the blood level of the drug and how well it works. More also needs to be~     known about how this drug works with other anti-rejection drugs and how it works in boys and~     girls. This study will look more closely at proper dosing, how Cellcept works with other~     anti-rejection medications, side effects, and any differences in how this medicine works in~     boys and girls.~      All patients in the study will be receiving Cellcept and have blood levels of the drug drawn.~     Results of their usual treatment and testing will be recorded and evaluated for signs of~     rejection. All the information will be analyzed. Results of this study will be reported to~     transplant committees locally and nationally.~   "
258523|NCT00166140|"~     Heparin is an anticoagulant or blood thinner. Heparin is always given to patients~     undergoing open-heart surgery to prevent blood from clotting when a patient is placed on the~     heart-lung machine. Heparin works by combining with a protein in blood to prevent other~     proteins from working together to form a clot. The protein that heparin combines with seems~     to be different in infants and young children compared to adults.~      The purpose of this study is to determine which proteins in children have a direct impact on~     the way heparin works. We also want to see how this may change at different ages. We will~     enroll two age groups of children; birth to 2 years and 10 years or older. A total of 125~     patients will be enrolled into this study. These patients will already be scheduled for~     open-heart surgery using a heart-lung machine.~      The testing involves taking blood samples when the patient is asleep for surgery; and later~     from their intravenous line, IV. They will all have IV's in place already because of the~     surgery. Therefore the study will cause no pain or discomfort for the patients who take part.~   "
258524|NCT00166127|"~     The purpose of this study protocol is to evaluate the blood concentrations of levosimendan~     when administered at different doses clinically employed during cardiopulmonary bypass or~     cardiac manipulation during off pump surgery in patients who require the drug for inotropic~     support (improved heart function) and the associated hemodynamic variables (vital signs).~     Levosimendan is one of the first agents in a new class of drugs used to treat heart failure~     and works via a unique mechanism called calcium sensitization, that makes the heart beat more~     efficiently. Levosimendan also has unique effects on the blood vessels, as well as causing~     relaxation, an important therapeutic approach of heart failure therapy.~   "
258525|NCT00166114|"~     Men and women who have suffered sexual and/or physical abuse before the age of 12 are at~     increased risk for anxiety and mood disorders, other serious psychiatric disorders, and~     likely medical illnesses. What is not known is whether adult survivors of childhood adversity~     experience heightened negative emotions and increased physical responses due to altered~     norepinephrine or serotonin systems in their brains and bodies. The investigators expect to~     see that survivors of childhood adversity experience heightened negative emotions and~     increased physical responses to stress.~   "
258526|NCT00166101|"~     Due to the small size of infants and the use of bypass machines, physicians have difficulty~     assessing whether the infant's brain and body is getting enough oxygen during heart surgery.~     This study compares continuous monitoring via the NIRS (Near Infrared Spectroscopy) to the~     traditional methods of determining oxygen saturation.~   "
258527|NCT00166088|"~     Problem of Interest:~      A typical American diet that is high in an intake of fats (especially saturated fats and~     cholesterol) is known to lead to high blood levels of cholesterol, hardening of the arteries,~     and increases the risk of heart disease. The American Heart Association recommendations to~     follow a diet that is low in the amount of fat, and specifically cholesterol, that is eaten~     can improve blood levels of cholesterol but can lead to a high intake of sugars (especially~     processed sugars) that can lead to obesity and continued heart problems.~      Studies of people who eat a diet that is typical of the Mediterranean region have shown that~     this type of diet leads to reductions in heart disease as well as forms of cancer. A typical~     Mediterranean diet has a large amount of fruit, vegetables, whole grain breads and cereals,~     beans, potatoes and seeds. Olive oil is the main source of fat and there is a daily use of~     dairy products (such as cheese and yogurt) in low to moderate amounts. The main meats are~     fish or poultry with rare red meat. Desserts are usually fruits with rare sweets. Wine is~     also used in low to moderate amounts with meals.~      No isolated aspect of the diet explains all of its benefits, but it is believed that the~     ingredient of the diet that most helps to reduce the risk of heart disease is the high amount~     of omega-3 fatty acids. Omega-3 fatty acids are found in fatty fish as well as in nuts and~     certain oils. Several studies of patients with either known heart disease or risk factors for~     heart disease have shown a reduction in heart disease events, such as heart attacks, as well~     as markers of heart disease risk when patients followed a Mediterranean diet. Other studies~     have shown that giving a supplement that contains omega-3 fatty acids to patients with heart~     disease or risk factors for heart disease also reduces heart disease events and markers of~     heart disease risk.~      In this current study we, the investigators at Emory University, plan to compare the effects~     of following a Mediterranean diet versus continuing to follow an American type diet and~     supplementing parts of the Mediterranean diet, including omega-3 fatty acids, on markers of~     heart disease risk. A third group will continue to follow their usual diet without~     supplements to serve as a control.~      How Problem Will be Studied:~      In this initial study we will compare three groups. One group will receive one month of~     prepared meals that will follow a Mediterranean diet. This group will also receive extensive~     counseling and education on how to maintain a Mediterranean diet. During the second month of~     the study this group will be encouraged to continue following a Mediterranean diet by~     themselves with assistance from a nutritionist. The second group will be asked to continue on~     their current diet and receive supplements that are important parts of the Mediterranean~     diet. These supplements will include an omega-3 fatty acid capsule, walnuts and grape juice.~     A third group will be asked to continue their current diet and level of activity without~     supplements to serve as a control. We will follow the effects on markers of heart disease~     risk. We will also determine if patients are able to continue following a Mediterranean diet~     on their own or whether simply taking supplements is easier.~      Advancement in Scientific Knowledge:~      This study will advance scientific knowledge by comparing the effects of following a~     Mediterranean diet versus simply taking supplements of the believed to be important aspects~     of the Mediterranean diet. We will also be able to determine if it is easier to follow a~     Mediterranean diet or take supplements for patients who are currently ingesting a typical~     American diet.~      Standard of Care:~      Currently the recommended diet for all Americans is a Step 1 American Heart Association diet~     that is low in fat and specifically low in saturated fats and cholesterol. As stated above,~     despite these recommendations, there is a growing problem of obesity in the United States and~     there is evidence to suggest that a Mediterranean diet may be better.~   "
258530|NCT00166049|"~     The purpose of the Education and Supportive Partners Improving Self-Care (ENSPIRE) study is~     to compare the effect of a Family Partnership Intervention (FPI) over patient and family~     education and usual heart failure care on physical and mental health outcomes over an 8-month~     period. The study will examine three ways of giving heart failure patients and their family~     members information. This study will help scientists determine if learning these~     communication skills will help people with heart failure to better manage their symptoms and~     improve their health outcomes.~   "
258531|NCT00166036|"~     Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were~     randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily.~     Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid~     reactive substances [TBARS], and aminothiol levels) and brachial artery flow-mediated~     dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.~   "
258532|NCT00166023|"~     Infective endocarditis is a rare disease, and while there have been several large reviews of~     the incidence of endocarditis in the pediatric patient population, relatively little has been~     published regarding the short and medium-term outcomes following medical and surgical therapy~     for this disease. The goal is to compare the outcome for children treated for endocarditis~     with either medical management or surgery by looking at the success of these two treatment~     strategies. Another goal is to attempt to identify risk factors for medical management that~     might identify patients who would be better served by early surgery.~   "
258533|NCT00166010|"~     Children with severe heart failure need immediate appropriate care. New and better drugs are~     constantly being developed. As these drugs are approved for adult use, they are used~     off-label for children. The Food and Drug Administration (FDA) encourages clinical studies of~     drugs in children to further extend appropriate use of new medicines.~      This study involves nesiritide, which was approved as a congestive heart failure treatment in~     adults in August 2001. The investigators' use of this drug in a pediatric population with~     severe heart failure has been encouraging. The investigators now wish to formally determine~     the pharmacokinetic and safety of Nesiritide in children.~      The investigators will enroll 30 patients who are in the cardiac intensive care unit with~     severe heart failure. The data collected will include weights, vital signs, laboratory~     results, and echocardiography results. A research lab test called B-type natriuretic peptide~     (BNP) will be done several times during this study. If the patient still has an intravenous~     (IV) catheter, the blood sample will be taken from the IV. If the patient does not have an~     IV, the sample will be taken from a fingerstick.~      The duration of the study will be the first 2 days of the patient's stay in the cardiac~     intensive care unit and thru discharge to evaluate the endpoint safety of Nesiritide.~     Additional information will also be collected if patient gets re-admitted within 30 days of~     discharge.~   "
258534|NCT00165997|"~     Radiofrequency ablation is a procedure done in the Catheterization Laboratory to help correct~     specific problems that cause the heart to beat faster than it should. Quality of life~     includes the physical as well as the emotional aspects of a patient. Doctors have always~     tried to take care of a medical problem with minimal physical and emotional risk. It is~     assumed that once the medical problem is fixed, the patient will have an improved quality of~     life. To know if this assumption is true, the investigators are asking children scheduled for~     this procedure, along with their family, to answer questions before the ablation, then answer~     the same questions 5-6 months after the ablation.~   "
258535|NCT00165984|"~     There are many kids born with congenital heart disease. Some of these defects may lead to the~     formation of a single ventricle (the heart having only one pumping chamber). These children~     normally undergo a series of corrective surgeries to help overcome the problems of having~     just one ventricle. However there are some differences in how well the patients respond to~     the surgeries. In the adult population, studies have shown that there may be a genetic link~     that may be responsible for the differences in how patients respond. The investigators would~     like to study the pediatric population by looking for certain genetic markers in the~     patients' blood. They will also collect basic health information on each patient.~   "
258536|NCT00165971|"~     General anesthesia allows people to have surgery without experiencing the procedure or pain.~     To remain unconscious, the depth of sleep must be monitored. Various monitors have been~     developed, one of which is BIS (short for bispectral index). BIS monitors the level of sleep~     during anesthesia and improves patient recovery because the amount of sleep drugs can be~     fine-tuned to the individual. Patients who need a lot to stay asleep get more, and those who~     need less get less. As a result, patients tend to wake up faster with BIS monitoring as~     compared to standard practice not using BIS. Little is known about the long-term effects of~     BIS monitoring. This study investigates whether BIS monitoring during anesthesia improves~     long-term outcome, well after surgery is over. The hypothesis is that it does. Two groups of~     patients are compared: one in which BIS monitoring was used, and one in which it was not.~     Groups are compared on tests of memory, concentration and mental well-being, to see if one~     does and feels better than the other. The investigators also take blood samples to see how~     well patients' bodies deal with the surgery. The investigators expect the BIS monitoring~     group to do better.~   "
258537|NCT00165958|"~     The purpose of this trial is to compare two standard of care treatments for removing~     epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the~     skin. A punch incision makes a smaller hole through which the cyst can be removed. The~     trial's purpose is to determine if one method is better than another in terms of recurrence,~     infection, or other side effects.~   "
258538|NCT00165945|"~     In this study, the investigators wish to use images obtained from standard of care cardiac~     MRI's performed at Children's Healthcare of Atlanta and transfer the images to a different~     computer in order to analyze them with a new computer. The investigators are hoping to better~     their understanding and management of complex congenital heart disease.~   "
258553|NCT00165750|"~     This study investigate the relationship between regional brain volume measured by MRI and~     donepezil treatment response in patients with Alzheimer's Disease.~   "
258554|NCT00165737|"~     Twenty-four week, prospective, randomized, double-blind, placebo-controlled, parallel-group~     study.~   "
258555|NCT00165724|"~     Open study for efficacy and safety of donepezil treatment during 48 weeks~   "
258556|NCT00165711|"~     Patients who fit the inclusion criteria are admitted into the study. They are given 3 IV~     injection of MBL in the first week and one tablet three times a day for 16 weeks.~   "
258539|NCT00165932|"~     At Children's Healthcare of Atlanta, children who have irregular heart rhythms are often~     referred for evaluation. Sometimes they also need a procedure to correct their irregular~     heart rhythm. An echocardiogram is routinely used as part of their evaluation and follow-up.~     The echocardiogram including Tissue Doppler Imaging (TDI) works by bouncing sound waves off~     the heart similar to radar. A new echocardiogram technology, Tissue Synchronization Imaging~     (TSI), should help doctors look at heart function compared to heart rhythm. All three of~     these are noninvasive, which means they work from a probe outside the body and are not~     painful.~      The purpose of this study is to see how Tissue Synchronization Imaging works in patients with~     heart rhythm problems. We will use patients who have a heart irregularity. We will also look~     at children and young adults with normal heart function to establish normal values for TSI.~      All pediatric patients we approach for this study will receive an echocardiogram recommended~     by their cardiologist (standard of care), plus TSI, a new part of a heart ultrasound The~     young adult population will undergo a heart ultrasound plus TSI. This young adult population~     will be selected from medical students at Emory University. During the consent process, the~     medical students will be informed that participation is voluntary and if they decide not to~     participate, it will not affect their grades, etc.~   "
258540|NCT00165919|"~     The purpose of the study is to investigate the immune response to hepatitis C virus to~     determine why some people clear the virus and others develop chronic infection. Changes in~     immune response once hepatitis C therapy is begun will also be examined. If patients are also~     HIV+, the effect of antiretroviral therapy on the recovery of hepatitis C immunity will be~     investigated.~   "
258541|NCT00165906|"~     Children having open heart surgery must be on a heart-lung bypass machine. It is essential~     that the blood in the heart-lung machine does not clot. This is accomplished by giving a drug~     called heparin, a blood thinner.~      The process of making a clot involves a lot of steps. One of the steps involves a protein~     called thrombin. Heparin acts on thrombin to keep blood from clotting. A technique has been~     developed to measure the blood's ability to generate thrombin. The bloods's ability to~     generate thrombin is measured by a thrombin generation curve (TGC). This curve would be very~     helpful to know when choosing the dose of heparin. We haven't found any studies using TGC in~     babies less than a month old.~      We want to do a study comparing the TGC in 10 newborns without a heart defect to the TGC in~     10 newborns with a congenital heart defect. To do this we will need one sample of blood. the~     sample we need is 3 cc which is a little more than 1/2 teaspoon. The blood sample for both~     groups is to be taken from the intravenous catheter (IV) the child will have placed for~     surgery. The newborns without a heart defect will be children having surgery for a~     non-cardiac problem.~   "
258542|NCT00165893|"~     This study is looking at a new machine called the Accu-Spina which administers internal disc~     decompression by following a computer program. This non-surgical treatment (similar to~     traction) is being compared to a rigorous physical therapy program.~   "
258543|NCT00165880|"~     The overall purpose of this study is to compare the efficacy, safety and tolerability of~     indisulam in combination with capecitabine (IC) versus capecitabine (C) monotherapy in~     patients with metastatic breast cancer who have previously been treated with an anthracycline~     and a taxane.~   "
258544|NCT00165867|"~     The overall purpose of this study is to determine the efficacy, safety and tolerability of~     indisulam in combination with irinotecan as a treatment for patients with metastatic~     colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).~   "
258545|NCT00165854|"~     Part 1: The primary purpose is to determine the recommended dose of E7070 in combination with~     capecitabine by dose adjustment. Part 2: The primary purpose is to determine the safety and~     efficacy of the combination in patients with metastatic CRC resistant to 5-fluorouracil and~     irinotecan.~   "
258546|NCT00165841|"~     The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a~     maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal~     Reflux Disease (s-GERD).~   "
258547|NCT00165828|"~     Patients with focal epileptic seizures with or without generalization who are at present~     treated with one or two antiepileptic drugs are eligible for this study, provided that they~     fulfill all inclusion criteria and none of the exclusion criteria. Following a baseline phase~     of 8 weeks duration, the patients are randomised and they receive an initial daily dose of 50~     mg zonisamide during the first week. The daily dose is then increased to 200 mg zonisamide in~     group A or 400 mg zonisamide in group B, respectively. After eight weeks of treatment, the~     daily dose in group A can be increased to 300 mg in case of insufficient efficacy. Control~     assessments are performed at the beginning of the study and at the end of the prospective~     baseline phase, if applicable and after 4, 8, 12, and 16 weeks. At the end of the first,~     second, and third treatment week, and at the end of week six, the patient is additionally~     contacted by telephone. Efficacy and safety parameters are assessed at baseline, during all~     control visits, and at the end of the study.~   "
258548|NCT00165815|"~     A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.~   "
258549|NCT00165802|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 after~     bolus IV administration, on Day 1 of a 21-day cycle, to patients with advanced solid tumors~     that have progressed following effective therapy or for which no effective therapy exists.~   "
258550|NCT00165789|"~     This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects~     will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and~     receive treatment for a total of ten weeks (Days 1 to 70).~   "
258551|NCT00165776|"~     To evaluate efficacy and safety of E2014 (2500U, 5000U, 10000U, placebo) in a multicenter,~     randomized, double-blind, parallel group comparative study by intramuscularly administering~     to patients with spasmodic torticollis. Primary endpoint for efficacy evaluation is changes~     in TWSTRS total scores from baseline measured at Week 4 and the clinical recommended dose~     will be examined with Williams multiple comparison. For safety evaluation, an inter group~     comparison (active drug and placebo) will be performed mainly focusing on incidence of~     adverse events, adverse drug reactions, and abnormal changes in laboratory parameters.~   "
258552|NCT00165763|"~     The purpose of this study is to examine the efficacy and safety of cholinesterase inhibitor~     (donepezil hydrochloride) Aricept in patients with vascular dementia (VaD).~   "
258558|NCT00165685|"~     To investigate the efficacy and safety of KES524 in patients with obesity (visceral fat~     obesity with type 2 diabetes and dyslipidemia), a 52-week, double-blind, placebo-controlled~     comparative study is conducted. This study aims to examine superiority of KES524 to placebo~     by employing change and percent change in body weight (primary endpoints) and changes in~     proportion of subjects achieving ≧ 5% weight reduction, BMI, waist circumference, visceral~     fat area, subcutaneous fat area, V/S ratio by abdominal CT scan, HbA1c, TG and HDL-C~     (secondary endpoints).~   "
258559|NCT00165672|"~     To investigate esophageal reflux condition in patients with non-erosive gastroesophageal~     reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week~     treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).~   "
258560|NCT00165659|"~     To evaluate the dose-response efficacy of E2020 (5 mg/day and 10 mg/day) versus placebo and~     verify superiority of E2020 to placebo in patients with severe AD using CIBIC-plus* and SIB**~     as the primary efficacy measures. Safety of E2020 will also be evaluated.~      (*for overall evalution of clinical symtoms) (**for cognitive function test)~   "
258561|NCT00165646|"~     To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of~     E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux~     disease in a multicenter, randomized, double-blind, comparative study.~   "
258562|NCT00165633|"~     The purpose of this study is to determine the superiority of inhibitory effects and safety of~     Menatetrenone (E0167) on recurrence in patients with hepatocellular carcinoma.~   "
258563|NCT00165620|"~     To establish the optimum injection rate for E7337 (Iomeron 350) in dynamic CT in patients who~     have hepatic lesions.The primary endpoint for efficacy is the contrast enhancement effect in~     the early arterial phase, and the primary safety endpoints are warming sensation and vascular~     pain.~   "
258564|NCT00165607|"~     To investigate a new incidence and preventive effect of menatetrenone on vertebral fracture~     in patients with osteoporosis who were randomly assigned to either treatment arm receiving~     daily dose of calcium supplement as a monotherapy (calcium monotherapy group) or~     menatetrenone plus calcium supplement as a combination therapy (menatetrenone combo therapy~     group) for 36 months, followed by a 12-month follow-up observation to examine the preventive~     effect on the fracture risk.~   "
258565|NCT00165594|"~     Phase I study:~      To investigate primary objective (maximal tolerated dose and dose-limiting toxicity) and~     secondary objectives (pharmacokinetics, safety, estimation of a recommended dose, and~     anti-tumor effect by evaluable case) of E7070 in patients with gastric cancer who are~     extensive or intermediate metabolizer type (EM/IM) to CYP2C9 and CYP2C9 by intravenously~     administering once every 3 weeks.~      Phase IIa study:~      To investigate primary objective (response rate for efficacy assessment) and secondary~     objectives (frequency and severity of adverse drug reactions, and pharmacokinetics) of E7070~     in patient with gastric cancer who are EM/IM type by intravenously administering once every 3~     weeks.~   "
258566|NCT00165581|"~     The purpose of this study is to understand the side effects (skin reaction, infection and~     abscess formation) at the site of radiation treatment, which my occur during the treatment~     and following 2 months using a new method of radiation therapy for breast cancer.~   "
258567|NCT00165568|"~     The purpose of this study is to investigate whether bevacizumab helps 5-Fluorouracil (5-FU)~     be delivered to the tumor more efficiently. Bevacizumab has been shown to inhibit the~     formation of new blood vessels in tumors and works best in combination with drugs that~     require blood vessels for transportation. Based on other experiments, bevacizumab may work by~     improving the transportation of other drugs to the tumor.~   "
258568|NCT00165555|"~     The purpose of this study it to determine the safety and maximally tolerated dose (MTD) of~     cisplatin administered in the operating room and put into the chest and abdomen for one hour.~     We are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees~     celsius.~   "
258569|NCT00165542|"~     The purpose of this study is to evaluate the sensitivity and specificity of A-PROTEIN~     levels in patients with brain tumors. A-PROTEIN levels will be analyzed both pre and post~     treatment. Levels in blood and/or cerebrospinal fluid (CSF) will be analyzed and correlated~     with the underlying diagnosis and outcome.~   "
258570|NCT00165516|"~     The purposes of this study are: to evaluate the effects (good and bad) that administering~     heated cisplatin into the chest and abdomen cavity following surgical resection has on~     malignant mesothelioma; to collect data on the toxicity of cisplatin given directly into the~     chest and abdomen, and the levels of the cisplatin in the body; to determine if this~     treatment method has the possibility of helping patients with pleural mesothelioma live~     longer; and to determine if this treatment method can help decrease the rate of local~     recurrence of mesothelioma.~   "
258571|NCT00165503|"~     The purposes of this study are: to determine the feasibility of administering adjuvant~     cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery;~     to determine the effects (good and bad) of this combined modality approach in patients with~     mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is~     excreted in the body from the collection of tissues and cisplatin samples; to collect and~     analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic~     make-up of the disease.~   "
258572|NCT00165490|"~     The purpose of this study is to find out what effects (good and bad) the combination of three~     chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when~     given with radiation therapy.~   "
258573|NCT00165477|"~     - The purpose of this study is to find out if the combination of lenalidomide and radiation~     therapy is effective in controlling tumor growth in patients with newly-diagnosed~     supratentorial glioblastoma or gliosarcoma.~   "
258574|NCT00165464|"~     This is a phase II study of taxotere, cisplatin and irinotecan (CPT-11) used in combination~     to treat metastatic esophageal and gastric cancer in an effort to see what effects (good and~     bad) the combination may have on the patients cancer.~   "
258575|NCT00165451|"~     This study will use a combination of four oral drugs (thalidomide, cyclophosphamide,~     etoposide and celecoxib) to treat patients with relapsed or progressive cancer. These drugs~     are expected to target the blood vessels that supply the tumors with what they need to grow.~   "
258576|NCT00165438|"~     The purpose of this study is to find out the impact Bleomycin-containing chemotherapy, given~     with or without chest radiation therapy, on patients' lung function over time.~   "
258577|NCT00165425|"~     The main purpose of this study is to determine if it is possible to put into practice a~     cardiac screening program for survivors of Hodgkin's disease. In this study, we would also~     like to screen for cardiac risk factors that can be modified either through life-style~     changes or medications, to uncover significant abnormal heart findings in which treatments~     may be needed, and to see if there is a link between cardiac health and quality of life.~   "
258578|NCT00165412|"~     The purpose of this study is to determine if the use of breast MRI in detecting breast~     malignancies in survivors of Hodgkin's disease is more successful than the traditional~     mammogram.~   "
258579|NCT00165399|"~     The purpose of this study is to see if the combination of chemotherapy drugs and drugs to~     suppress testosterone (hormone therapy) is effective in controlling early prostate cancer.~      This study will attempt to:~        -  stop or slow the growth of disease~        -  gain information about prostate cancer~        -  evaluate the effectiveness and side effects of the study drug~   "
258580|NCT00165386|"~     The purpose of this study is to target lesions of the prostate in the bone and to biopsy~     these lesions using MRI to identify the areas.~   "
258581|NCT00165373|"~     The purpose of this study is to assess the safety of rhEndostatin, to determine how much of~     the drug stays in the patients blood (pharmacokinetics), to assess the development of~     proteins in the blood that are produced by the body (antibodies)using rhEndostatin, to~     determine the effect of rhEndostatin on the formation of new blood vessel factors, and to~     perform an analysis of the effect of rhEndostatin on circulating endothelial precursor cells~     (cells in the body that help the tumor build more blood vessels).~   "
258582|NCT00165360|"~     The purpose of this trial is to determine the effects (good and bad) temozolomide has on~     patients with low-grade glioma. It will also determine whether temozolomide is effective in~     preventing or delaying future tumor growth.~   "
258583|NCT00165347|"~     The purpose of this study is to determine whether or not cancer cells in the body are~     affected by PTK and whether it affects the growth of these cells.~   "
258584|NCT00165334|"~     The purpose of this study is it to determine how well patients with non-small cell lung~     cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of~     cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell~     lung cancer.~   "
258585|NCT00165308|"~     The purpose of this study is determine whether or not tamoxifen reduces the chance of~     Hodgkin's Disease survivors developing breast cancer.~   "
258586|NCT00165295|"~     The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra)~     has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the~     function of several proteins necessary to the survival of certain types of cancer and~     laboratory tests have shown that it can destroy WM cells.~   "
258587|NCT00165282|"~     The main purpose of this study is to examine techniques to help patients cope better with the~     stem cell/bone marrow transplant procedure.~   "
258588|NCT00165269|"~     The purpose of this study it to evaluate the effectiveness of radiation therapy limited to~     above the diaphragm in patients with pathological stage IA-IIA Hodgkin's disease.~   "
258589|NCT00165256|"~     The purpose of this study is to determine if wide excision (surgical removal) alone is~     adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.~   "
258590|NCT00165243|"~     The purpose of this study is to evaluate whether treatment to the axilla (area under the arm)~     can be safely minimized by omitting axillary surgery and full axillary radiation therapy and~     replacing it with radiation therapy to the breast and lower axilla.~   "
258591|NCT00165230|"~     The purpose of this study is to find out what effects, good or bad, that thalidomide and~     temodar have on patients with neuroendocrine tumors.~   "
258592|NCT00165217|"~     The purpose of this study is to collect information about the antitumor activity and the~     safety of capecitabine and thalidomide in patients with colorectal cancer.~   "
258593|NCT00165204|"~     Women undergoing surgical menopause often experience marked menopausal side effects but are~     reluctant to use estrogen or other female hormones to ease the transition to menopause~     because of worries that the hormones may increase breast cancer risks. This study will~     evaluate tibolone in women experiencing surgical menopause to assess its effects on bone~     health, menopause symptoms and breast density.~   "
258594|NCT00165191|"~     The purpose of this study is to collect information on the anti-tumor activity of the~     combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced~     esophageal or gastric adenocarcinoma. We will also be collecting information about the side~     effects and safety of this combination.~   "
258595|NCT00165178|"~     The purpose of this study is to reduce the side-effects from anti-leukemia therapy. The~     therapy in this study is based upon treatment information learned from prior clinical~     research programs as well as from laboratory research.~   "
258596|NCT00165152|"~     To evaluate two different ways of providing information about genetic testing for BRCA1 and~     BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed~     consent which cover similar material but are organized differently.~   "
258597|NCT00165139|"~     The main purpose of this study is to determine the short and long term side effects of a very~     intensive treatment, which includes combinations of chemotherapy drugs followed by radiation~     therapy and two transplants supported by peripheral blood progenitor cells (stem cells), for~     children with advanced stage neuroblastoma and sarcomas.~   "
258598|NCT00165126|"~     The purpose of this study is to investigate the effect of certain variables such as the~     fullness of the patients bladder and the position of the treatment applicator on the dose of~     radiation that other organs such as the bladder and the rectum receive during radiation~     treatment for endometrial carcinoma.~   "
258599|NCT00165100|"~     The purpose of this study is to evaluate whether this new method of taking pictures called~     Dynamic Area Telethermometry (DAT) might be a good way of looking at patients with cancer~     that is relatively close to the surface of the body.~   "
258600|NCT00165087|"~     The purpose of this study is to reduce the side-effects and discomfort of anti-leukemia~     therapy, to attain long-term control of the disease and to hopefully eradicate it.~   "
258602|NCT00165061|"~     A multicenter randomized comparison of primary esophagectomy against definitive~     chemoradiotherapy for the treatment of squamous esophageal cancer.~   "
258604|NCT00165035|"~     The purpose of this study is to evaluate the safety and effectiveness of the investigational~     stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison~     to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the~     treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels)~     coronary artery disease.~   "
258605|NCT00165022|"~     A questionnaire composed of items addressing psychological, emotional and social aspects of~     GERD is developed for Chinese population. We plan to conduct a validation study on this novel~     disease-specific quality of life (QoL) instrument. This study aims to evaluate various~     indicators of validity and reliability, which include criterion validity, test-retest~     reliability, responsiveness, internal consistency reliability and discriminant validity.~      After initial pilot testing of face validity and content validity, two hundred GERD patients~     from the gastroenterology and ulcer clinics of cluster NTE hospitals will be invited to~     complete a revised 18-item version of GERD-QOL questionnaire. The data from GERD QOL will be~     evaluated using exploratory factor analysis to identify appropriate items and domains and the~     internal consistency of the domains will be determined and further refinement of~     questionnaire will follow.~      100 GERD patients will complete GERD-QOL, SF-36 health survey and the visual analog scale~     (VAS) questionnaire for criterion validation. 100 GERD patients with stable symptom profile~     will repeat GERD QOL two weeks after the first administration for evaluation of test-retest~     reliability.~      Another 26 patients who are receiving maintenance acid suppressive therapy and in remission~     of symptom will be recruited as controls for comparison with active reflux patients. The~     ability to distinguish active patients from controls in remission is known as discriminant~     validity.~   "
258606|NCT00165009|"~     To compare the efficacy of a novel endoscopic clipping device(Resolution Clip™) and~     conventional epinephrine injection and heater probe thermocoagulation in control of peptic~     ulcer bleeding and prevention of recurrent bleeding~   "
258607|NCT00164996|"~     The purpose of this study is to investigate whether an ultrathin endoscope will improve a~     patient's tolerance during the procedure. In addition, this study will look at whether local~     pharyngeal anaesthesia is necessary during ultrathin endoscopy.~   "
258608|NCT00164970|"~     Background: Vitamin B12 and folate are essential to brain health. Sub optimal status of~     vitamin B12 and folate leads to elevation of plasma homocysteine concentration, which is~     associated with Dementia. Vitamin B12 and folate supplementation improved the cognitive~     function of demented subjects with hyperhomocysteinaemia in a pilot study.~      Objective: To determine the effectiveness of vitamin B12 and folate supplementation in~     preserving cognitive function of subjects with early dementia~   "
258609|NCT00164957|"~     Background:~      Tube feeding had been found to be a cause of aspiration pneumonia. Continuous pump feeding at~     slower rates as compared to bolus feeding may be less associated with aspiration pneumonia.~      Methods:~      Randomized controlled trial~      Subjects:~      Patients expected to remain on tube feeding for 4 or more weeks~      Outcomes:~      1) pneumonia, 2) mortality~   "
258610|NCT00164944|"~     To determine the prevalence of colorectal neoplasms in first degree relatives of those~     affected with sporadic colorectal cancer using colonoscopy as a screening tool. The~     prevalence will be compared to that of a defined matched cohort.~   "
258611|NCT00164931|"~     A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion~     against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic~     endoscopy.~   "
258612|NCT00164918|"~     The aim of the study is to evaluate whether subtotal gastrectomy without post-operative~     nasogastric decompression is better in terms of early post-operative bowel function and chest~     complication.~   "
258613|NCT00164905|"~     The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients~     who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail~     endoscopic therapy.~   "
258614|NCT00164892|"~     The purpose of this study is to investigate the efficacy of selective COX-II inhibitor in~     patients with curative resection performed for locally advanced stomach cancer.~   "
258615|NCT00164879|"~     The aim of this study is to compare the stoma rate, clinical efficacy, and safety of patients~     treated by endoscopic stenting followed by elective laparoscopic resection (the~     'endolaparoscopic approach') versus immediate emergency surgery for obstructing left-sided~     colorectal cancers.~   "
258616|NCT00164866|"~     To evaluate if intravenous PPI infusion, when administered prior to endoscopy, hastens~     resolution of bleeding stigmata and thereby facilitates endoscopic examinations and reduces~     the need for endoscopic treatment. Clot stabilization may itself sustain control of bleeding~     before endoscopy. These may translate into improved patients’outcome and survival.~      To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal~     bleeding from causes other than peptic ulcers.~   "
258617|NCT00164853|"~     To compare the technique of combined balloon sphincter dilation after an initial~     sphincterotomy and standard sphincterotomy in the endoscopic removal of large bile duct~     stones. The investigators hypothesize that combined balloon dilation and sphincterotomy~     allows for easier stone removal without added morbidities when compared to standard~     sphincterotomy.~   "
258618|NCT00164840|"~     Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended~     modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet~     in clinical practice treatment is commonly given in short courses on as required basis during~     symptom flare up, particularly for patients with mild to moderate GERD.~      On-demand therapy also has the potential advantage that patient does not need to take regular~     medications, thereby improving the quality of life. However, whether on-demand PPI therapy~     achieves similar efficacy of symptom control is uncertain.~      The aim of this study is to compare the efficacy and quality of life of on-demand and~     maintenance PPI regimens in long-term management of non-erosive GERD patients. The~     investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.~   "
258619|NCT00164827|"~     To investigate the adjunctive role of “Capsule Endoscope” in continuous endoscopic monitoring~     and early detection of recurrent ulcer bleeding after endoscopic therapy in patients~     presenting with bleeding peptic ulcers~   "
258848|NCT00161837|"~     The objectives of the study are to assess the immunogenicity and safety of the inactivated~     influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.~   "
258620|NCT00164814|"~     Noncardiac chest pain (NCCP) is a common clinical problem worldwide. In Hong Kong, it has~     been estimated that about 20% of patients with chest pain are misdiagnosed to have coronary~     heart disease. Despite its benign nature, this condition causes anxiety, impairs quality of~     life and consumes a substantial amount of healthcare resources. While acid reflux and~     motility disorder in the esophagus are often attributed as the cause of NCCP, visceral~     hyperalgesia of esophagus is now recognized to play a central role in the pathogenesis of~     this condition. This research project aims to evaluate the role of visceral hyperalgesia in~     Chinese patients with NCCP. NCCP patients will be evaluated for the prevalence of~     gastroesophageal reflux disease and esophageal motility disorder by endoscopy, manometry and~     pH study. The visceral sensory and pain thresholds of these patients will be compared with~     asymptomatic controls.~   "
258621|NCT00164801|"~     The effect of baclofen (GABAB agonist), diltiazem (muscle relaxant) and placebo will be~     compared in a double-blinded randomized study for the treatment of NCCP. Cerebral cortical,~     brainstem and spinal evoked potentials before and after treatment will be evaluated. Results~     of this study will shed lights on pathogenesis and treatment of NCCP in Chinese.We~     hypothesize that Baclofen alleviates visceral hyperalgesia in NCCP patients by suppressing~     afferent sensory pathway.~   "
258622|NCT00164788|"~     The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by~     8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in~     such a high dose either intravenous or orally is identical.~   "
258623|NCT00164775|"~     The aim of this study is evaluate the efficacy of Imipramine, a tricyclic antidepressant, in~     treatment of functional dyspepsia. This is a double blind randomised placebo controlled trial~     in which consecutive patients with diagnosis of functional dyspepsia will be studied. After~     exclusion of organic cause of dyspepsia by endoscopy, these patients will be randomly~     assigned to either imipramine or placebo. All the patients will enter an additional 4 weeks~     of drug withdrawal phase after the initial 12 weeks of study drug treatment. They will be~     evaluated for treatment response, which is defined as satisfactory relief of dyspeptic~     symptoms at the end of 12-week treatment.~   "
258624|NCT00164762|"~     The purpose of this study is to determine whether the addition of zidovudine (ZDV) and~     lamivudine (3TC) at the onset of labor and for up to seven days postpartum to single-dose~     nevirapine (NVP) is associated with a lower prevalence of NVP-resistant HIV compared to~     single-dose NVP without ZDV+3TC.~   "
258625|NCT00164749|"~     The purpose of this study is to develop procedures for testing the effectiveness of curcumin~     on slowing Alzheimer's disease (AD) progression.~   "
258626|NCT00164736|"~     This is a comparative clinical trial among HIV-infected women and their infants to determine:~        1. the benefit of nutritional supplementation given to women during breastfeeding~        2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to~          their mothers to prevent HIV transmission during breastfeeding~        3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding~          cessation~   "
258627|NCT00164723|"~     To evaluate the incidence and etiology of small bowel or large bowel bleeding in patients~     presenting with melena.~   "
258628|NCT00164710|"~     Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria~     in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that~     the drug is much less effective than in previous years. This study was developed and~     conducted in collaboration with the National Malaria Control Programme of Malawi to assess~     the efficacy of four antimalarial drug combinations to provide evidence to assist the~     Malawian Ministry of Health in identifying and implementing as policy the next first-line~     antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children~     under five years of age, four drug combinations, all of which are licensed in Malawi, are~     being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus~     artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and~     lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current~     data on its efficacy. Data on side effects of the drugs will also be collected. The results~     of this study will provide some of the information necessary to guide the Malawi National~     Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated~     malaria. The study adheres to the World Health Organization's 2003 standardized protocol for~     assessing antimalarial drug efficacy.~   "
258629|NCT00164697|"~     The purpose of this study is to determine if an intervention focused on promoting~     parent-child interaction, parental responsibility, parental commitment of time and energy,~     and sense of community results in better developmental outcomes for low-income children.~   "
258630|NCT00164684|"~     A 16 session curriculum, developed for noncustodial African American and Latino fathers to~     improve knowledge, attitudes and skills and enable participants to remain non-violent towards~     their partners will be evaluated.~   "
258631|NCT00164671|"~     The intent of this project is to replicate the POWER pilot campaign using a randomized~     controlled trial with neighborhoods as the unit of randomization and analysis. We plan to~     rigorously test the effects of the POWER campaign on women’s knowledge of, attitudes toward~     and use of female and male condoms for the prevention of sexually transmitted disease (STD)~     and unintended pregnancy. We will work in 12 non-contiguous neighborhoods in four~     southwestern U.S. cities (four each in Oakland/Alameda County and Los Angeles and two each in~     San Diego and Las Vegas). We will complete a baseline assessment in all 12 neighborhoods to~     document knowledge of, attitudes toward and use of female and male condoms. We will then~     randomly assign six neighborhoods to intervention status and six neighborhoods to control~     status. We will adapt the campaign for each city, and implement it in six intervention~     neighborhoods for nine months, and will complete a follow-up assessment similar to the~     baseline assessment, with added questions regarding exposure to the POWER campaign. Study~     partners include Dr. Sheana Bull and research staff from the Colorado Health Outcomes Program~     (COHO) of the University of Colorado Health Sciences Center, Educational Message Services~     (EMS), and Centers for Disease Control and Prevention (CDC).~   "
258632|NCT00164658|"~     The study will evaluate the effect of familial risk assessment and prevention prompts~     tailored to familial risk on health behaviors and use of preventive services among adults who~     are members of primary care practices in the U.S.~   "
258633|NCT00164645|"~     Family caregivers of persons with traumatic brain injury (TBI) have long-term demands that~     tax their coping abilities and adversely affect their health and well-being. This project~     will test the effectiveness of a problem-solving training program tailored to the unique~     needs of family caregivers of persons with TBI. Over a 3-year period, family caregivers and~     their care recipients will be recruited and randomly assigned to a problem-solving~     intervention group (n=40 dyads) or a control group (n=40 dyads). Participants in the~     problem-solving intervention group will receive four face-to-face problem-solving training~     sessions and monthly telephone problem-solving sessions over the course of 1 year. Control~     group participants will receive a handbook of educational materials and a staff member will~     contact each control group participant monthly by telephone to review these materials and~     other informational needs. No problem-solving training will be provided to control~     participants throughout the year.~      Caregivers and care recipients will be assessed at four points during their participation: at~     the initial assessment, at 4 months, at 8 months, and at the completion of the 1-year~     participation period. All evaluations will be conducted in the participants' homes. Measures~     of problem-solving ability, caregiver burden, and adjustment (depression, health,~     satisfaction with life) will be collected. Structural equation modeling and other~     regression/inferential analyses will be used to determine the effects of problem solving on~     caregiver adjustment over time after taking into account care recipient adjustment and~     caregiver ethnicity. This project will: (1) demonstrate how specified physical and emotional~     outcomes of caregivers and care recipients are related to caregiver problem-solving abilities~     and how these relationships vary as a function of time; (2) evaluate the effectiveness of a~     community-based, problem-solving intervention that will be delivered to caregivers; and (3)~     identify caregivers and care recipients with TBI who are at risk for adverse emotional and~     health outcomes.~   "
258634|NCT00164632|"~     A randomized controlled multi-component fall prevention study for older adults. The study~     integrates fall prevention into an existing community-based public health program for older~     adults.~   "
258635|NCT00164619|"~     The purpose of the project is to determine whether the VOICES/VOCES intervention, that was~     shown to be effective in a research study, is still effective when delivered by STD/HIV~     prevention agencies.~      VOICES/VOCES is a brief, single-session intervention for African-American and Latino adult~     men and women at high risk for STD/HIV. It encourages condom use and improves condom~     negotiation skills. A health educator delivers the intervention to groups of 4 to 8 clinic~     patients in a private room. Groups are made up of people of the same sex and same race or~     ethnicity. Information on STD/HIV risk behaviors and condom use is delivered by~     culturally-specific videos, group discussion, and a poster presenting features of various~     condom brands. Participants role-play condom negotiation modeled in the videos. At the end of~     the session they are given sample condoms of their choice.~      In this project, health educators from the health departments of New York City and San Juan,~     Puerto Rico conducted the VOICES/VOCES intervention with a sample of patients from one STD~     clinic in each of their cities. Researchers helped the health departments test whether the~     intervention is effective when local health educators deliver it.~   "
258636|NCT00164606|"~     This is a population-based evaluation of the effectiveness of the Triple-P-Positive Parenting~     Program. Triple-P is a system of parenting programs with multiple levels that aims to provide~     parents with parenting skills and support.~   "
258637|NCT00164593|"~     This project is an evaluation of an intervention to involve youth in creating community~     change for peace promotion and violence prevention. The intervention, Youth Empowerment~     Solutions for Peaceful Communities (YES), includes three components: youth empowerment~     activities, neighborhood organization development, and community development projects that~     involve youth and organizations working together.~      Hypothesis 1: Efforts to engage youth in the community change process will enhance their~     attachment to their community, reduce their problem behaviors, and begin to change norms~     among their peers about community violence and interpersonal problem solving.~      Hypothesis 2: Efforts to make community-based organizations more youth-friendly and engaging~     will assist them to be more effective in reaching their community enhancement goals and will~     expand youth involvement in their mission.~      Hypothesis 3: Efforts to create more health-enhancing land use (e.g., beautification,~     community gardens, parks development) will improve social organization (e.g., social capital,~     social cohesion, and social support), and reduce the level of violent incidents and crime in~     the community.~   "
258638|NCT00164580|"~     The purpose of this study is to test whether a multi-component, community-level,~     HIV-prevention intervention is more effective than existing HIV prevention activities in~     reducing unprotected anal intercourse (UAI) among men ages 15-25 who have sex with men.~   "
258639|NCT00164567|"~     The purpose of this study is to implement universal screening for intimate partner violence~     (IPV) and to test two clinic-based interventions for women who screen positive for current or~     recent IPV. The study population will be implemented in Pee Dee region of the state of South~     Carolina and will include primarily low-income women who seek care at selected primary health~     care clinics in the region.~      In this study, all women 18 and older receiving care at selected primary care clinics will be~     offered screening for IPV annually. Clinicians will use a structured screening tool to assess~     physical, sexual, and psychological IPV in a current relationship (IPV+) or IPV experienced~     by the woman in the past five years (Recent IPV). Clinics will be randomly assigned to~     implement a clinic-based intervention for women who screen positive for current or recent~     IPV. Two interventions will be implemented using a factorial design. In the~     Empowerment-Focused Patient Education Intervention, clinicians will conduct a 7-session~     intervention focusing on the health and well-being of the woman and attempt to link women's~     IPV experience with their health. In the IPV Services Intervention, IPV Specialists who are~     trained advocates from the Pee Dee Coalition Against Domestic and Sexual Assault (PDC) will~     be based in the clinic to (a) counsel women about IPV including safety planning, (b) provide~     linkages to PDC services, and (c) link women to clinic-based support groups developed~     specifically for this project.~      We hypothesize the intervention(s) will change (a) clinician screening, referral, and IPV~     documentation patterns, (b) clinician IPV knowledge and perceived skills in working with~     women who have experienced IPV and their children (c) women's help-seeking behaviors, risk of~     poor mental and physical health, and (d) women's risk of subsequent IPV victimization. To~     evaluate these outcomes, we will survey clinicians and prospectively follow a group of~     consenting IPV+ women (N=300 in each intervention arm) to assess changes in their~     help-seeking, health behavior and status, IPV experience over two-years of follow-up.~   "
258640|NCT00164554|"~     Children will receive comprehensive evaluations through the UOHSC ABC program The assessment~     for the child will include: medical issues (including medication), dysmorphic examination,~     intellectual assessment, academic achievement, language, and motor skills. This program will~     provide appropriate non-study services and referrals. Eligible families will be randomly~     assigned to treatment group or control group. Treatment group will receive Parent Child~     Interaction Therapy (PCIT). The Control group will receive standard referrals and services~     through the ABC program and the parent education/advocacy component of the project.~   "
258641|NCT00164541|"~     this project will evaluate a community and school based program to promote healthy~     relationships and prevent violence (physical, emotional and sexual dating violence) among~     predominately African American middle school adolescents in an urban setting (Baltimore, MD).~   "
258712|NCT00163618|"~     The objective of this study is to assess the TBE antibody persistence approximately three~     years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in~     children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series~     in Study 146A.~   "
258745|NCT00163189|"~     To estimate the evolution of height and growth rate over 5 years of growth hormone (GH)~     treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the~     good clinical and biological safety of GH treatment in such children~   "
258642|NCT00164528|"~     Children diagnosed through the FAS DPN clinic (who receive non-study services through the~     clinic/referrals) will receive baseline assessment. The baseline assessment for the child~     will include: medical issues (including medication), intellectual assessment, academic~     achievement, language, social functioning, executive functioning, neurological assessment,~     perceived self-confidence, and behavioral observation of parent-child interactions~     (videotaped and coded). For caregivers, baseline assessment will include: demographics,~     medical histories, educational history, current services, satisfaction with services,~     knowledge of FAS, stress, parenting competence, and family functioning.~   "
258643|NCT00164515|"~     This study aims to increase physical activity among overweight African-American women with~     mobility limitations.~   "
258644|NCT00164502|"~     The goal of the project is to develop and test the efficacy of a community-based~     self-management intervention for reducing pain, depression, and improving self-efficacy and~     function in person with limb loss~   "
258645|NCT00164489|"~     This research is meant to evaluate the effectiveness of two different prevention programs for~     post-acute management of rheumatoid and osteo-arthritis~   "
258646|NCT00164476|"~     Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a~     participatory action research project to test an intervention package combining a resource~     kit with peer mentoring in improving consumer education about primary preventive services~   "
258647|NCT00164463|"~     This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin~     alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the~     pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with~     multidrug therapy (isoniazid or ethambutol, rifampin, and pyrazinamide) to those of healthy~     volunteers receiving moxifloxacin plus rifampin. It also evaluates the association between~     polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin pharmacokinetic parameters, the~     effect of polymorphisms of MDR1 genotype and/or rifampin pharmacokinetics on isoniazid~     pharmacokinetic parameters adjusted for N-acetyltransferase genotype (NAT2), and determines~     by multivariate regression analyses the associations between moxifloxacin or rifampin~     pharmacokinetic parameters and markers of tuberculosis disease severity including the~     covariates of two-month culture positivity, cavitary lung disease, Body Mass Index, weight,~     duration of study treatment prior to PK, co-morbidities and C-reactive protein. Healthy~     volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period~     after ingesting a dose of TB drugs.~   "
258648|NCT00164450|"~     Compared to adults, children appear to require higher weight-based doses of rifapentine to~     acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability~     of weekly rifapentine/isoniazid for three months versus daily isoniazid for nine months for~     the treatment of latent tuberculosis infection, has been amended to include children ages~     2-11 based on an initial single-dose study and pharmacokinetic modeling. Study 26PK evaluates~     the adequacy of the doses chosen for young children enrolled in Study 26 with a single blood~     draw, 24 hours after the third or subsequent weekly Study 26 dose of rifapentine and~     isoniazid. An adult control is enrolled for each child enrolled.~   "
258649|NCT00164437|"~     The study populations consist of a sample of the patient population (men aged 40-79 years) of~     a large, group model HMO and a community sample of men age 50-79. Follow-up interviews of men~     randomly assigned to the intervention and control groups are being conducted by telephone to~     assess issues related to prostate cancer screening and the men’s use of the CD-Rom~     educational intervention.~   "
258650|NCT00164424|"~     The purpose of this study is to determine if acyclovir episodic treatment has an effect in~     ulcer healing and if it should be added to the syndromic management of genital ulcer disease.~   "
258651|NCT00164411|"~     The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination~     (tetanus shot) before giving pneumococcal vaccine makes the pneumococcal vaccine more~     effective without causing too many side effects.~   "
258652|NCT00164398|"~     The purpose is to encourage Provider participants to evaluate high risk HIV transmission~     behaviors and offer prevention messages to their HIV+ patients which will, in turn, reduce~     rates of unprotected anal and/or vaginal sex with partners of known HIV sero-negativity or~     unknown HIV serostatus. It is hypothesized that patients of providers participating in the~     HIP intervention will report higher reduction in sexual risk practices, when compared to the~     patients of the providers who were randomized into the control condition.~   "
258653|NCT00164385|"~     The primary objective of Adolescent Impact is to develop and evaluate a developmentally~     targeted intervention designed to minimize secondary transmission risk behavior and enhance~     adherence to care and treatment. The intervention is delivered in 12 sessions (five~     one-to-one, 7 group) over a 3 month period of time. Intervention is delivered in addition to~     standard of care treatment at the participant's respective clinic. Participants are~     randomized to either an intervention or control arm; the control group receives standard of~     care treatment and control group participants are offered the Adolescent Impact intervention~     following the completion of the nine-month follow up. It is hypothesized that compared to~     control group participants, intervention group participants will evidence (1) improved or~     stable virologic and/or immunologic status, mediated by (a) adherence to prescribed~     antiretroviral medication and/or (b) adherence to HIV care appointments, and (2)~     reduction/minimization of secondary transmission risk behaviors to include (a) unprotected~     sex and/or needle sharing, and (b) sexual and drug use behaviors that increase risk for~     unprotected sex.~   "
258654|NCT00164372|"~     The purpose of this study is to test whether a six-session behavioral intervention for HIV~     and HCV seronegative injection drug users is effective in reducing sexual and injection risk~     behaviors that could lead to primary HIV and HCV infection.~   "
258666|NCT00164216|"~     This is a study of the efficacy and effectiveness of combination therapy for malaria due to~     P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects~     ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients~     will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and~     artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one~     will receive drugs under direct supervision and the other will be instructed on how to take~     the drugs by themselves. Clinical and parasitologic response will be monitored for a~     follow-up period of 28 days. The findings of this study will be used to guide the Ministry of~     Health in evaluating its national policy for P. falciparum malaria treatment.~   "
258655|NCT00164359|"~     Sulfadoxine-pyrimethamine is the current first-line therapy for uncomplicated malaria in~     Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to~     an imminent need for the government of Malawi to identify a new first-line therapy for~     uncomplicated malaria and to implement that new therapy as policy. This protocol is the~     second of two protocols whose combined purpose is to provide efficacy and side effect data on~     four antimalarial drug combinations that are candidates for the next first-line therapy for~     uncomplicated malaria in Malawi. This protocol aims to assess the acceptability and~     tolerability of amodiaquine in Malawi. It is a double-blind study comparing amodiaquine plus~     artesunate (AQ-Art, one of the candidate combination therapies) to chlorproguanil/dapsone~     plus artesunate (CD-Art, another of the candidate combination therapies) in persons 5 years~     and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the~     therapy in the AQ-Art group. Amodiaquine was removed from the Malawian national drug registry~     in 1995 because of a perceived association with abdominal pain. Although no studies were~     conducted to substantiate this, consensus among clinicians was that patients were refusing~     amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was~     removed from the registry. Results from this study, along with the efficacy data from the~     sister protocol in children under five years of age, will help guide the National Malaria~     Control Program of Malawi in selecting their next first-line antimalarial therapy.~   "
258656|NCT00164346|"~     Children will receive comprehensive evaluations through the Children's Research Triangle~     (CRT) clinical program. The assessment for the child will be in accordance with the protocol~     developed by Astley and Clarren as performed by one of the clinic pediatricians and final~     diagnosis will be according to Institute of Medicine (IOM) criteria. Children will be~     randomized into either a Treatment or Control group. The Treatment group will receive (in~     addition to standard referrals) neurocognitive habilitation and psychotherapy services as~     well as parent psychoeducation. The Control group will be referred for intervention through~     existing community and school-based agencies.~   "
258657|NCT00164333|"~     The purpose of the study is to test the efficacy of TAP, a behavioral intervention, in~     improving sexual safety and treatment adherence among gay and bisexual men infected with HIV.~     It is hypothesized that those who are in the intervention group will report reductions in~     unprotected sex with HIV-negative and unknown-status partners; and will show stricter~     adherence to their treatment regimens, compared to the individuals in the standard-of-care,~     control group.~   "
258658|NCT00164320|"~     The purpose of this study is to determine if the TEAM prevention intervention delivered by a~     physician and an HIV-positive counselor is effective. It is hypothesized that those who~     receive the intervention will report a higher reduction in risky sex than those who were in~     the standard-care condition.~   "
258659|NCT00164307|"~     Children will be randomly assigned to a Parent-assisted social skills training or Wait list.~     Baseline and post intervention rating will be obtained from teachers.~   "
258660|NCT00164294|"~     Disability and death from injury remain a persistent problem in the U.S. and risk-taking~     behaviors are known to contribute to injury. Healthy People 2010 set goals to reduce deaths~     caused by injury: Motor vehicle crashes are often predictable and preventable. Increased use~     of seat belts and reductions in driving while impaired are two of the most effective means to~     reduce the risk of death and serious injury of occupants in motor vehicle crashes. One~     preventive strategy is to establish screening and intervention procedures that can be~     administered in the ED to young adults who have risky driving practices and problem drinking.~     Goal: The specific aim of this prospective, randomized controlled trial is to test the~     effectiveness of a brief intervention to limit risky driving behaviors (risky driving~     practices, lack of seat belt compliance) and problem drinking in drivers during an ED visit.~     In addition, the trial will result in a benefit-cost analysis from the perspectives of both~     society as a whole and hospitals in particular. Methods: Young adults 18 to 44 years will be~     screened for problem drinking and risky driving practices during an ED visit. Subjects who~     screen positive for problem drinking and risky driving will be randomized to one of three~     groups: No Contact Control Group (NCG: after informed consent, subjects receive no screening~     or intervention until 12 months after injury). Contact Control Group (CCG: subjects screened~     at baseline and every three months for 12 months but no intervention), and a Brief~     Intervention Group (BIG: subjects receive screening and brief intervention with data~     collection points every three months for 12 months). A total of 133 subjects per group~     (N=400) will be enrolled. The intervention will consist of a 20 minute nurse visit in the ED~     and a booster intervention at 7-10 days after ED discharge. All subjects will be telephoned~     at 3, 6, 9, and 12 months by interviewers blinded to condition. Outcomes of interest include~     reported alcohol use, risky driving behaviors, driving citations, adverse health outcomes,~     and costs (health care utilization, property damage, travel delays, lost work productivity,~     criminal justice expenses, and monetarized adverse health outcomes). Analysis: Power analysis~     suggests that 133 subjects in each arm of the trial will have sufficient power to detect a~     difference of the main outcome variables of interest. A variety of regression techniques,~     including individual growth curve modeling and event history analysis, will be used to test~     the proposed hypotheses.~   "
258661|NCT00164281|"~     This is a randomized, blinded, two-arm comparative trial of continued versus limited~     isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and~     Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of~     36 months.~   "
258662|NCT00164268|"~     The purpose of the project is to examine the efficacy of a culturally-based intervention,~     compared to standard agency services, in enhancing self-care among Native Hawaiian women and~     decreasing IPV/SV perpetration and related factors among Native Hawaiian men.~   "
258663|NCT00164255|"~     This study is an investigation to compare the efficacy of two different intermittent~     sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine~     (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing~     placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally~     efficacious and safe as intermittent protective SP, such a regimen could be adapted for~     programmatic use as a potentially more durable alternative to SP monotherapy in areas of~     increasing SP resistance.~   "
258664|NCT00164242|"~     Tardive dyskinesia (TD), a form of movement disorder, remains a problem for some patients who~     received antipsychotic medications. Increasing evidence suggests that TD may result from~     antipsychotic-induced dysfunction in striatal cholinergic neurons. To test whether~     cholinesterase inhibitors compensate for diminished cholinergic activity underlying TD, we~     conducted a 30-week randomized, double-blind, placebo-controlled crossover study of~     galantamine in 36 patients with TD.~   "
258665|NCT00164229|"~     Comprehensive evaluation (geneticist, psychologist, social worker, education specialist,~     others as indicated) to determine individual needs and treatment plan. Referrals for specific~     services (e.g., OT, counseling, medications, etc) will be to clinicians within the families'~     own communities. All families will receive evaluation, parent education/advocacy, and~     learning readiness program. Only the intervention group will receive the math intervention.~   "
260149|NCT00144534|"~     This is an open-label, extension, Phase III study to evaluate the long-term safety and~     efficacy of MRA in patients with RA who participated in Study MRA213JP.~   "
258667|NCT00164203|"~     Anxiety and mood disorders are among the most prevalent mental health problems in childhood.~     They have severe long-term morbidity, and associated academic and social impairment.~      Building on the investigators' experience with outcome evaluation in clinically anxious or~     depressed children, they propose to evaluate within the school system a cognitive behavioral~     therapy (CBT) intervention for children in grades 3 to 6 with elevated symptoms of anxiety or~     depression on standardized questionnaires.~      The participant's outcomes will be compared with those of similar children randomly assigned~     to an activity control group.~      Hypothesis 1a): Children in the intervention condition will show greater symptom reduction~     relative to children in the control condition (primary outcome: anxiety symptoms).~      Hypothesis 1b): Children in the intervention condition will show fewer symptoms during~     follow-up relative to children in the control condition.~      Hypothesis 2: Children with anxious or depressive symptoms treated in the school setting~     using CBT have a lower risk of developing internalizing disorders within 1 year of treatment~     than children in a control condition.~      Hypothesis 3: Self-esteem, anxiety and depression-related impairment, and academic~     functioning will improve more in intervention participants than in controls.~      Hypothesis 4: School characteristics, child age, and attitudes of participating personnel are~     predictive of treatment response.~   "
258668|NCT00164190|"~     Background:~      In Canada, most patients with acute myocardial infarction (AMI) present to hospitals without~     cardiac catheterization facilities. Thrombolytic therapy remains the standard-of-care in~     these centres. However, thrombolytic therapy achieves normal coronary flow and myocardial~     perfusion in less than 50% of patients, and is associated with reocclusion, reinfarction, and~     recurrent ischemia. Primary angioplasty results in more complete reperfusion and lower rates~     of reocclusion, reinfarction and recurrent ischemia, but is not available in most centres.~     Although patients can be transferred for primary angioplasty, long transport times are~     associated with worse outcomes. An alternative strategy, described as facilitated~     angioplasty, involves administration of thrombolytic therapy at the community hospital~     followed by immediate transport for angioplasty. This approach achieves the benefits of~     primary angioplasty without delaying treatment. A well-conducted, prospective, randomized~     trial is needed to compare this strategy of facilitated angioplasty with standard~     thrombolytic therapy.~      Objectives:~      To evaluate the safety, feasibility, and efficacy of routine transfer of patients with AMI to~     an angioplasty centre immediately after thrombolysis for coronary angiography and~     percutaneous coronary intervention (PCI).~      Hypothesis:~      A strategy of routine transfer of patients with AMI to an angioplasty centre immediately~     after thrombolysis for coronary angiography and percutaneous intervention is associated with~     a significantly lower incidence of the composite of death, reinfarction, recurrent ischemia,~     heart failure, and shock at 30 days compared with the conventional strategy of thrombolysis~     with transfer reserved for failed reperfusion and/or development of shock.~      Research Plan:~      Patients with ST-elevation myocardial infarction and high-risk characteristics presenting to~     community hospitals without cardiac catheterization facilities will receive thrombolysis with~     tenecteplase and heparin (unfractionated or low molecular weight heparin) and will then be~     randomized to one of two strategies: facilitated PCI or standard treatment (thrombolysis with~     provisional rescue PCI). In the facilitated PCI group, patients will be transferred~     immediately to an angioplasty centre for urgent cardiac catheterization, and PCI if~     appropriate. In the standard treatment group, patients will only undergo urgent angiography~     for evidence of failed reperfusion and/or development of cardiogenic shock. The primary~     endpoint will be the composite of death, reinfarction, recurrent ischemia, heart failure, and~     shock at 30 days.~   "
258669|NCT00164177|"~     To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult~     patients undergoing virtual colonoscopy (VC).~   "
258670|NCT00164164|"~     The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L~     NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.~   "
258671|NCT00164151|"~     The objective of this study is to determine the efficacy and safety of HalfLytely as compared~     to Visicol as bowel preparations before colonoscopic examination.~   "
258672|NCT00164138|"~     Women with chronic lung disease characterised by chronic cough report urinary incontinence.~     Recently there have been reports of increased urinary incontinence in girls and women with~     cystic fibrosis. While coughing is a known risk factor for stress incontinence, other risk~     factors and causes are poorly understood in this population. Treatment of incontinence for~     patients with chronic lung disease is also poorly addressed, adding to the burden of disease~     for women with chronic lung disease, carers and the health system. This project will estimate~     the prevalence of women with CF and COPD compared to healthy age matched controls and will~     evaluate the effect of a specific treatment and management program for these patients. The~     results will be disseminated to respiratory health professionals. We hypothesise that women~     with chronic cough will have a higher incidence of urinary incontinence than healthy controls~     and that a specific treatment program will result in alleviation of the problems and improved~     quality of life.~   "
258673|NCT00164125|"~     To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated~     patients.~   "
258674|NCT00164112|"~     Studies have previously shown that a broad drug interaction screening can be performed using~     enzyme specific probes such as oral caffeine for CYP1A2, N-acetyltrasferase-2 (NAT-2), and~     xanthine oxidase (XO), warfarin plus vitamin K for CYP2C9, omeprazole for CYP 2C19,~     dextromethorphan for CYP2D6, and midazolam for CYP3A4/5. This combination of probes has been~     validated in the Cooperstown 5+1 Cocktail (5+1).1 The use of the 5+1 cocktail provides~     information on the drug metabolizing enzymes that metabolize 90% of hepatically eliminated~     drugs for a fraction of the costs of the individual studies. Using a cocktail of biomarkers~     reduces the overall cost of drug interaction screening. The purpose of this study is to~     evaluate the effects of three Food and Drug Administration (FDA) approved oral antibiotics~     (azithromycin, telithromycin, and levofloxacin) on metabolism of other medications when taken~     together. This will be determined by the measuring the activity of drug metabolizing enzymes~     following administration of certain drug probes (caffeine, dextromethorphan, omeprazole,~     midazolam, and warfarin with vitamin K). A total of 16 subjects will complete four phases of~     the study: 1) Cooperstown 5+1 alone, 2) Azithromycin plus Cooperstown 5+1, 3) Telithromycin~     plus Cooperstown 5+1, and 4) Levofloxacin plus Cooperstown 5+1.~   "
258694|NCT00163852|"~     Adult cystic fibrosis (CF) patients admitted with an acute infection complicated by acid-base~     disturbance and decreased ventilation will be studied.~      They will receive salt replacement to correct the acid-base disturbance and possibly their~     ventilation.~      Assessment of symptoms (questionnaire), acid-base and electrolyte status (blood and urine~     tests) ventilation (overnight oxygen and carbon dioxide monitoring non-invasively) and~     sleep-wake pattern (actigraphy) will be carried out.~      Study hypothesis: Acute volume and electrolyte replacement corrects hypochloremic hypovolemic~     metabolic alkalosis and compensatory hypoventilation/ hypercapnia in acute exacerbations of~     cystic fibrosis.~   "
258695|NCT00163839|"~     This study involves investigating the effects of a pseudoallergen-free (active) diet compared~     with a control (placebo) diet in the treatment of Chronic Idiopathic Urticaria (CIU) and/or~     Angioedema. The hypothesis is that over a four-week intervention period, the~     pseudoallergen-free diet will be more effective than the placebo diet in reducing the~     frequency and severity of CIU and/or Angioedema.~   "
260383|NCT00141453|"~     The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus~     placebo on the progression of diabetic renal disease.~   "
258675|NCT00164099|"~     All surgical procedures carry with them the risk of infection. Even a minor infection can~     extend the hospitalization after cardiac surgery. The average minimum increase in length of~     stay for a single infection is three days.~      One of the many means used to reduce post-operative infections is the preventative, or~     prophylactic, administration of antibiotics just before and just after surgery. Because~     antibiotics, and for that matter surgery itself, alter the body's natural immune and~     inflammatory responses and the makeup of the bacteria in the intestine, there is a great deal~     of scientific interest in using the supplementation of bacteria that naturally reside in the~     intestine. It is felt that by doing so, the alterations in the immune response may be~     corrected and the patient better able to fight infections. There are studies using probiotics~     that have demonstrated a reduction in infection rates in patients undergoing abdominal~     surgery.~      Subjects will be patients at high risk for infection including those with any one or more of~     the following characteristics: over 65 years old, poor heart function (ejection fraction~     <40), diabetes (insulin dependant or non-insulin dependant), peripheral vascular disease,~     kidney dysfunction (creatinine level >2mg/dl), obesity (body surface area > 2 m2), low serum~     protein levels (albumin < 2.5 mg/dl), infection of the heart valve (endocarditis), or on any~     antibiotics other than standard prophylaxis before surgery.~      The safety of these products has been very well established.~      Patients who consent to enter the study will receive the synbiotic mix, or a placebo, which~     comes in a powder that may be mixed with a drink, or washed down into the stomach through the~     NG tube if the patient is still on a ventilator. Dosing will be initiated within four hours~     of patient arrival in the Cardiac Surgery Intensive Care Unit and will continue on a twice~     daily basis for the duration of their admission days. Infection and diarrhea data will be~     monitored.~   "
258676|NCT00164086|"~     The purpose of this trial is to study the effects of a medication already widely used to~     treat cardiovascular disease and diabetes, in reducing the progression of myeloma.~   "
258677|NCT00164073|"~     The purpose of this study is to examine gene expression profiles by DNA microarray in~     patients who are responders and non-responders to interferon and ribavirin treatment for~     hepatitis C virus (HCV). Genes involved in inflammation and fibrosis and mediators of the~     Th-1 lymphocyte response will be looked for. It is hoped that genetic targets for future more~     effective and less toxic treatments will be identified.~   "
258678|NCT00164060|"~     The purpose of this study is to examine the effect of GB virus C (GBV-C) on the natural~     history of chronic hepatitis C virus (HCV) infection in subjects co-infected with HIV and~     HCV. The other aspect of the study is to assess the effect of GBV-C on the severity of liver~     disease due to chronic hepatitis C in subjects co-infected with HIV and HCV. This will be~     done by determining the point prevalence of co-infection retrospectively then following that~     cohort prospectively. In addition, further individuals will be recruited in a prospective~     manner.~   "
258679|NCT00164047|"~     We aim to investigate the effectiveness and safety of nitrous oxide (N2O) in anaesthesia.~      Hypothesis In patients undergoing anaesthesia for major surgery, avoidance of N2O will reduce~     hospital length of stay when compared with otherwise identically managed surgical patients~     receiving N2O as a component of their anaesthesia.~   "
258680|NCT00164034|"~     Test the hypothesis that the implementation of real-time, computer-prompted algorithms in the~     first half hour of trauma management will result in a measurable reduction in management~     errors associated with the reception and resuscitation of major trauma patients.~      Demonstrate that a reduction in management errors will translate into a reduction in~     morbidity and mortality.~   "
258681|NCT00164021|"~     Gastro-oesophageal reflux (GOR) has been found to be prevalent in children with cystic~     fibrosis (CF)and may further worsen lung damage via reflex bronchospasm or pulmonary~     aspiration. Chest physiotherapy may result in increased episodes of GOR as demonstrated in~     children. Lung transplantation may worsen pre-existing GOR. This study will determine the~     prevalence, severity and significance of symptomatic and silent GOR in adults with CF before~     and after lung transplant using 24hr oesophageal pH monitoring, a valid symptom~     questionnaire, quality of life questionnaires and gastric emptying studies. This study will~     identify the extent of GOR in a large adult CF population and the impact on lung function and~     quality of life together with the effects of medical and physiotherapy treatment on~     gastro-oesophageal function.~   "
258682|NCT00164008|"~     The purpose of this trial is to see whether zoledronic acid is better than pamidronate to~     treat low bone density in heart and lung transplant patients.~   "
258683|NCT00163995|"~     This study looks at the iontophoresis of urotensin II in chronic liver disease patients.~   "
258684|NCT00163982|"~     This study is looking at the detection of vasoactive peptides in portal hypertension.~   "
258685|NCT00163969|"~     This clinical trial will determine if postoperative patients who have postoperative pain,~     which has been refractory to morphine administration, will have improved pain relief~     following a bolus administration of ketamine as compared with an ongoing morphine dosing~     regimen~   "
258686|NCT00163956|"~     The inferior vena cava (IVC) is a large vein that enters the bottom part of the heart. Venous~     blood from the lower portion of the body drains into the IVC. The IVC then returns blood back~     to the heart. An IVC filter is placed to help prevent the blood clots moving from the legs to~     the heart or lung. The idea behind using a filter in the IVC is to capture potential fatal~     pulmonary emboli at an anatomical location where they may pose less risk for the patient.~     Early filters, 1960's and 70's were, remained in the vein permanently. More recently,~     temporary or retrievable filters have been developed and are being widely used.~      Complications have been demonstrated with long-term placement of IVC filters. In a randomised~     study it was found that that patients with IVC filter placement had greater than three times~     the incidence of recurrent deep vein thrombosis (DVT) compared to their control population at~     two years. Blockage of the vein, recurrent pulmonary emboli, filter penetration and filter~     fragmentation have all been described.~      With the advent of retrievable filters (filters that can be place temporarily and then~     removed at a later date) there has been renewed popularity for placement of temporary~     filters. To our knowledge, no one has yet to follow the population of intended temporary IVC~     filters, who undergo failed retrieval, and consequently end up with a permanent IVC filter.~      We plan to prospectively enrol 40 Alfred patients who have undergone a temporary IVC filter~     placement and subsequently have had failed IVC filter retrieval.~      Our aim is to evaluate the long term outcomes for patients with failed IVC retrieval.~      Specifically we will determine the risk, due to failed filter retrieval, of:~        -  IVC stenosis~        -  IVC occlusion~        -  Development of DVT and~        -  analyse the clinical outcomes (symptoms), their prevalence and their distribution~      Patients will receive routine care and their data will be analysed annually as collected. The~     follow-up period is indefinite and will be at the discretion of the treating doctor.~   "
258707|NCT00163683|"~     In this study we will compare the effects of a Mediterranean diet, high in fruit and~     vegetables with the more conventional diet recommended for diabetes therapy (a high~     carbohydrate, low fat diet) on glycaemic and lipid control and on markers of inflammation, in~     people with newly diagnosed Type 2 diabetes. The hypothesis is that, over a six-month~     intervention period, a HVM diet will be more effective than a conventional HCLF diet in~     improving glycaemic and lipid control, and in reducing markers of vascular inflammation in~     people with Type 2 diabetes.~   "
258744|NCT00163202|"~     The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as~     compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week~     treatment period in subjects with documented coronary artery disease.~   "
258687|NCT00163943|"~     An abdominal distribution of fat is associated with the greatest heart disease risk, because~     commonly, several risk factors of metabolic origin (high blood pressure, unfavourable~     cholesterol profile, elevated blood sugar, impaired insulin action) cluster in these~     individuals. When this occurs the condition is called the 'metabolic syndrome' (MetS). The~     cause of the MetS is yet to be fully elucidated. Increased activity of the nervous system~     resulting in enhanced release of the stress hormone 'norepinephrine', may be one mechanism by~     which adverse cardiovascular and metabolic sequelae of the MetS might be mediated. Dietary~     weight loss, and exercise are first-line treatments for the MetS and provide an opportunity~     to prevent or delay the development of type 2 diabetes and heart disease in this high risk~     group. However, there is a paucity of data regarding the effects of these lifestyle factors~     on the nervous system. Furthermore, it is also unknown whether active weight loss ('negative~     energy balance') or a stable lower weight (weight loss maintenance) is more important in~     modifying MetS components and nervous system activity. The aims of the proposed project are:~        1. To determine whether dietary weight loss in combination with aerobic exercise is more~          beneficial than dietary weight loss alone in reducing nervous system activity and~          improving metabolic and cardiovascular parameters in middle-aged men and women with~          abdominal obesity and the MetS.~        2. To determine whether weight loss maintenance four months after active weight loss is~          associated with a preservation of clinical benefits.~        3. To study biological determinants of successful weight loss and weight loss maintenance.~   "
258688|NCT00163930|"~     This project seeks to evaluate the effectiveness of a new post-operative pain relief program~     for women who have undergone uterine artery embolisation (UAE).~      UAE is performed by an interventional radiologist as a treatment of uterine fibroids~     (non-cancerous growths of the uterus.) UAE can be associated with a high level of~     post-procedural pain and it is the purpose of this study to evaluate a new relief regimen for~     dealing with this acute pain.~      There will be two treatment groups into which patients will be randomly assigned. One will~     receive the current post-operative therapy (dose-on-demand) and the other will receive the~     new therapy (pre-emptive dosing). Otherwise patients will receive standard management~     protocol for this procedure. Only patients that are scheduled for UAE will be enrolled (up to~     40 patients).~      The new treatment involves giving the patient their morphine dose orally and sixty minutes~     before the procedure begins (pre-emptive dosing) as opposed to current standard treatment~     which involves giving the patient a dose of morphine intravenously once they feel pain.~      Information to be collected directly from patients includes pain and nausea levels, indicated~     on a visual scale (a 10 centimetre line showing a spectrum of no pain to worst pain~     imaginable) as well as their opinions of the effectiveness of the pain relief program and the~     procedure itself. This information is to be collected immediately post-procedure and at 2, 4,~     6 and 24 hours post procedure. Each VAS will take the patient approximately 20 seconds to~     complete. Information about concurrent medication and procedure complications, post-operative~     vomiting and respiratory depression will be collected from the patient’s history.~   "
258689|NCT00163917|"~     The purpose of this study is to evaluate whether a sub-population of patients with burn~     injuries needing dressing changes respond to virtual reality (VR) utilising relaxation themes~     with improved pain and anxiety scores, when added to PCA morphine and background analgesic~     therapy.~   "
258690|NCT00163904|"~     This study is looking at overweight patients with chronic heart failure (CHF), to compare the~     effects of a modified fat diet with a reduced glycaemic load (diet 1); and a conventional low~     fat, high carbohydrate diet (diet 2) on:~        -  insulin sensitivity (using the homeostasis model assessment [HOMA] model)~        -  lipid profile~        -  symptomatic status (6 minute walk distance and Heart Failure Quality of Life [HF QOL]~          Questionnaire)~        -  body weight~        -  inflammatory mediators (tumor necrosis factor [TNF] alpha, C-reactive protein [CRP],~          interleukin-6 [IL-6])~      The hypotheses of this study are:~        -  Diet 1 will be associated with lower insulin resistance than diet 2.~        -  The lipid profile will be better in CHF patients on diet 1 than on diet 2.~        -  Patients on diet 1 will have a better symptomatic status than patients on diet 2.~        -  Diet 1 will maintain body weight in patients with CHF as well as diet 2.~        -  Diet 1 will suppress the expression of TNF-alpha, CRP and IL-6 more than diet 2.~   "
258691|NCT00163891|"~     Chest infection is a common complication following lung transplant (LTx). Chest physiotherapy~     is widely accepted as an integral part of the management of chest infections, however there~     is no evidence available regarding the effectiveness of chest physiotherapy regimes for LTx~     recipients.~      There is no consensus regarding whether LTx recipients should be instructed to perform~     regular daily chest physiotherapy routines regardless of the presence of lung secretions (ie~     prophylatically) because of the changes in mucus clearance bought about by lung transplant,~     or only when they have a chest infection. Some clinicians believe that a prophylactic regimen~     may be beneficial.~      This research will compare two chest physiotherapy treatment regimens - our current practice~     of chest physiotherapy during chest infections only (Treatment A) with an independently~     performed daily chest physiotherapy regimen regardless of the presence of a chest infection~     (Treatment B). From this research, we aim to develop evidence-based treatment guidelines.~   "
258692|NCT00163878|"~     A randomised control trial of patients who have a severe brain injury to determine if~     patients who receive a standardised sensory stimulation program emerge earlier from a~     vegetative state. The experimental group would receive, in addition to their normal~     occuaptional therapy, sensory stimulation which would involve the daily application of~     stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation~     Technique (SMART).~   "
258693|NCT00163865|"~     The aim of the following pilot study is to examine boredom in a community sample of~     adolescents and a clinical sample of adolescents. This is important in order to examine~     differences among healthy adolescents and adolescents with mental illness.~   "
258708|NCT00163670|"~     Patients who have sleep disorders may be involved in accidents more frequently than those~     without. In addition patients who have sleep disorders may have more serious accidents and~     have increased length of stay.We aim to recruit drivers admitted as a result of a motor~     vehicle accidents and to ascertain the prevalence of sleep disorders in this group.~   "
258709|NCT00163657|"~     The purpose of this study is to compare three treatment regimens in patients who have~     received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C~     infection.~   "
258696|NCT00163826|"~     The Alfred Hospital receives approximately 40% of the major trauma patients in Victoria, all~     of whom are at risk for spinal injuries. The potential for spinal injuries necessitates the~     undertaking of appropriate spinal investigations, and a delay in the completion of these~     investigations exposes the patient to the risk of a missed diagnosis of spinal instability~     and of complications of immobility; the potential spinal patient is required to wear a neck~     collar and be nursed lying flat whilst awaiting the completion and the appropriate~     documentation of spinal X-ray investigations.~      The purpose of this study is to identify the issues causing a delay in the process of the~     completion of the appropriate spinal investigations and the documentation of the results.~      The outcome of the proposed research will be the development of a clinical management~     protocol to expedite the process, with the aim of optimising patient care and reducing~     complications.~   "
258697|NCT00163813|"~     This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a~     frictional nasojejunal [NJ] tube) and standard feeding in critical illness.~   "
258698|NCT00163800|"~     This study will attempt to evaluate clinical, laboratory and radiographic parameters together~     to assess heir values in outcome prediction from brain injury. Patients will be followed up~     for a period of 6 months, following admission to ICU, to assess outcome, using the Extended~     Glasgow Outcome Score (GOSE).~      We hypothesise that it is possible to reliably predict outcome in brain injury from the~     current investigations we have at our disposal.~   "
258699|NCT00163787|"~     All participants attend for two testing sessions at either Royal Talbot Rehabilitation Centre~     or the centre where they received inpatient physiotherapy services.~      All participants will be tested at discharge and at six months post discharge. Personnel used~     to score and administer the balance tests at six months will be blinded to pre-test scores,~     subject background, as well as, mobility and fall history in the six months post discharge.~      At discharge participants will perform two successful Four Square Step Tests (FSST, and will~     be videotaped performing the Timed Up and Go Test (TUGT. The turn measure will be scored from~     this TUGT. Participants will also complete the Locomotor Capabilities index (LCI).~      At the six-month test participants repeat balance and mobility tests and LCI, as well as~     being interviewed to ascertain fall history since discharge.~   "
258700|NCT00163774|"~     Analysis of cerebral blood flow (CBF) and oxygenation using complementary focal and global~     monitoring techniques will permit the delivery of more informed individualised and 'targeted'~     therapy on the patient with severe head injury, reduce episodes of secondary brain injury and~     therefore improve outcomes.~      Aims~        -  To develop a deeper understanding of Cerebral Blood Flow and auto-regulation for TBI~          patients based on the results of data collected in patients post TBI.~        -  To establish the basis for further multi modality clinical trials in severely brain~          injured patients in the future.~        -  To improve understanding of the various secondary processes that continue to cause~          neuronal damage after the initial injury, and therefore affect patient outcome.~        -  To proceed to the second phase of the study, with the introduction of algorithms for~          treatment.~   "
258701|NCT00163761|"~     This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted~     outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and~     pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.~   "
258702|NCT00163748|"~     This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine~     combination chemotherapy with filgrastim support in an outpatient setting. Participating~     patients at the time of registration will have measurable relapsed or primary refractory~     lymphoma.~   "
258703|NCT00163735|"~     This study is designed to identify whether wines which are produced using the common~     potential food allergens such as proteins derived from fish, milk or egg are likely to~     contain sufficient food allergens to cause allergic reactions in susceptible individuals.~   "
258704|NCT00163722|"~     Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose~     immune system is impaired it causes severe infection. The people who are particularly at~     high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those~     with acute leukaemia who are having chemotherapy and those post bone marrow transplantation.~     Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with~     Invasive Aspergillosis die.~      The main reason for this high death rate is that our current diagnostic tests are not good at~     detecting infection or often only detect the infection at advanced stages when treatment is~     ineffective. Because of the limitations of current diagnostic tests the current practice is~     to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis.~     However studies have demonstrated that this therapy has only resulted in a minor reduction in~     the mortality rates and it also causes significant drug toxicity. It is a suboptimal~     treatment modality.~      New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are~     for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA~     in blood. Available data suggests that these new tests make an early diagnosis and seem to be~     able to monitor responses to treatment. However no study has been reported to date which~     demonstrates that the use of these tests can impact on important patient outcomes. This trial~     is being performed to determine whether the use of the new diagnostic tests to guide~     antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug~     toxicity and reduce the death rate in the high-risk patients as compared with the current~     standard method of diagnosis and treatment with EAFT.~   "
258705|NCT00163709|"~     A trial to examine whether a new heart failure blood test can improve the outcome of patients~     presenting to the Emergency Department with shortness of breath.~      We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency~     Department with shortness of breath will help identify additional patients with CHF and~     consequently to change practice and allow more patients to recieve correct treatment earlier.~   "
258706|NCT00163696|"~     The researchers are investigating a novel technique, the multi breath nitrogen washout~     technique, to measure airway changes in various respiratory diseases.~   "
258710|NCT00163644|"~     The hypothesis is that exercise will improve the physical performance and quality of life of~     bone marrow/ haemopoietic stem cell transplants.The aim of the trial is to provide definite~     clinical evidence as to which( if any) type of exercise is most beneficial for this patient~     population. It is also aimed at improving the provision of physiotherapy services to this~     group of patients.~   "
258713|NCT00163605|"~     The purpose of this study is to evaluate the performance and to monitor the safety of the~     bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated~     Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in Sinus Lift Procedures . This study~     will be conducted in two parts: part A evaluates safety and performance of MBCP-FS in bone~     regeneration i.e. the amount of new bone that is formed and its suitability for dental~     implant placement. Part B is designed to evaluate long-term safety and performance of the~     product, i.e. whether the newly-formed bone is suitable to retain implants.~   "
258714|NCT00163592|"~     This study investigates if the time to hemostasis can be reduced by application of Tissucol®~     onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as~     compression with swabs.~   "
258715|NCT00163579|"~     The purpose of this study is whether Bryophyllum is more effective and has less side effects~     than traditional labor inhibitors in preventing preterm delivery.~   "
258716|NCT00163566|"~     The purpose of this study is to evaluate whether DHT-Gel, when applied daily to the skin, can~     relieve the symptoms of low testosterone in men aged 55-80. These symptoms include reduced~     muscle strength, increase fat mass, low libido, feeling blue or moody~   "
258717|NCT00163553|"~     The hypothesis is that epidural pethidine is an effective form of pain relief following~     lumbar spinal surgery, resulting in significantly lower usage of concomitantly administered~     (intravenous) patient-controlled analgesia (PCA) pethidine.~   "
258718|NCT00163540|"~     The objective of this study is to investigate the immunogenicity and safety of a third~     vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination~     in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule~     12 ± 2 days apart.~   "
258719|NCT00163527|"~     Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally~     active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown~     effectiveness in the treatment of asthma.~      The aim of the study is to investigate the effect of roflumilast taken orally together with~     low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one~     dose level once daily together with inhaled corticosteroids at one dose level twice daily.~     The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24~     weeks). The study will provide further data on safety, tolerability, and effectiveness of~     roflumilast.~   "
258720|NCT00163514|"~     The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal~     spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of~     perennial allergic rhinitis.~   "
258721|NCT00163501|"~     The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal~     spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of~     perennial allergic rhinitis.~   "
258722|NCT00163488|"~     The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide~     nasal spray administered along with a fixed combination of inhaled fluticasone~     dipropionate/salmeterol.~   "
258723|NCT00163475|"~     Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally~     active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown~     effectiveness in the treatment of asthma.~      The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and~     use of rescue medication in patients with stable asthma. Roflumilast will be administered~     orally either in the morning or in the evening at one dose level. The study duration consists~     of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide~     further data on safety, tolerability, and effectiveness of roflumilast.~   "
258724|NCT00163462|"~     The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate~     on lung function, symptoms, and use of rescue medication in children with persistent asthma.~     Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone~     propionate will be inhaled at one dose level twice daily. The study duration consists of a~     baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide~     further data on safety and tolerability of ciclesonide.~   "
258725|NCT00163449|"~     The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school~     children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested~     versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a~     treatment period (24 weeks). The study will provide further data on safety and tolerability~     of ciclesonide.~   "
258726|NCT00163436|"~     The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung~     function and safety. Ciclesonide will be inhaled at one dose level once daily, using an~     inhaler device with or without spacer. The study duration consists of a baseline period (1 to~     3 weeks) and a treatment period (12 weeks).~   "
258727|NCT00163423|"~     The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate~     on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue~     medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be~     inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose~     level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a~     treatment period (24 weeks). The study will provide further data on safety and tolerability~     of ciclesonide.~   "
258728|NCT00163410|"~     The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate~     on lung function, symptoms, and use of rescue medication in children with persistent asthma.~     Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be~     inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to~     4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and~     tolerability of ciclesonide.~   "
258729|NCT00163397|"~     The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung~     function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and~     budesonide will be inhaled once daily at one dose level each. The study duration consists of~     a baseline period (1 to 4 weeks) and a treatment period (12 weeks). The study will provide~     further data on safety and tolerability of ciclesonide.~   "
259364|NCT00154895|"~     To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the~     rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.~   "
258730|NCT00163384|"~     This trial will compare the effectiveness of one dose of ciclesonide against one dose of~     budesonide in patients with asthma.~      The aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on~     pulmonary function, symptoms and use of rescue medication in patients with asthma. The onset~     of action and the safety and tolerability of ciclesonide in comparison to budesonide will~     also be investigated.~   "
258731|NCT00163371|"~     The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice~     daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on~     short-term lower leg growth in prepubertal children with mild persistent asthma. The study~     duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each~     treatment), and a wash-out period (2 weeks). The study will provide further data on safety~     and tolerability of ciclesonide.~   "
258732|NCT00163358|"~     The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of~     fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients~     with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a~     treatment period (12 months). The study will provide further data on safety and tolerability~     of ciclesonide.~   "
258733|NCT00163345|"~     The aim of this study is to evaluate the involvement of small airways in asthma, as~     determined by bronchial challenges, CT-scanning, and cellular markers of inflammation.~     Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a~     baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide~     further data on safety and tolerability of ciclesonide.~   "
258734|NCT00163332|"~     The aim of the study is to investigate the effect of ciclesonide versus fluticasone~     propionate versus placebo on airway hyperresponsiveness and on the~     hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as~     follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the~     two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five~     treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The~     study will provide further data on safety and tolerability of ciclesonide.~   "
258735|NCT00163319|"~     The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone~     propionate on the lung function, symptoms, use of rescue medication, and occurrence of side~     effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will~     be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily~     at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment~     period (24 weeks). The study will provide further data on safety and tolerability of~     ciclesonide.~   "
258736|NCT00163306|"~     Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and~     esophagus. GERD occurs when the lower esophageal sphincter does not close properly and~     stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common~     medical disorders, with estimates of up to 50% of adults reporting symptoms related to~     gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of~     GERD in a large proportion of patients.~      When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning~     sensation in the chest or throat. This sensation is often referred to as heartburn. Some~     patients have symptoms of GERD without visible destruction of the tissue surface (no visible~     changes by endoscopic examination).~      The aim of the study is to evaluate the effect of pantoprazole on the complete remission of~     GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief~     after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in~     the morning. Endoscopy will be performed at the start of the study, and then as required~     after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of~     pantoprazole.~   "
258737|NCT00163293|"~     The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of~     the number of asthma exacerbations in children with mild persistent asthma. Treatment~     medication will be administered as follows: ciclesonide will be inhaled once daily, using one~     of the two dose levels versus placebo together with other corticosteroids used as~     intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a~     treatment period (12 months). The study will provide further data on safety and tolerability~     of ciclesonide.~   "
258738|NCT00163280|"~     This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and~     whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT~   "
258739|NCT00163267|"~     The Mirror Study is a randomized, double-blinded mono-centre trial the access the~     periinterventinal and postinterventional administration of clopidogrel in patients with~     peripheral vascular disease.~   "
258740|NCT00163254|"~     The Below-Study is a randomized, prospective mono-centre trial on the efficacy and safety the~     adjunctive use of a GP IIb/IIIa antagonist for prevention of early reocclusion in arterial~     below-the knee interventions.~   "
258741|NCT00163241|"~     Objectives of the study:~      Primary: Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo~     administered once daily (QD) for 24 months in slowing disease progression as assessed~     radiographically in subjects with osteoarthritis (OA) of the hipSecondary:Assess the ability~     of a continuous treatment of celecoxib 200 mg versus placebo administered QD for 24 months in~     treating disease signs and symptoms in subjects with OA of the hip.Evaluate the ability of a~     continuous 24-month intake of celecoxib 200 mg QD versus placebo to reduce number of subjects~     eligible for hip replacement according to the investigator.Evaluate the tolerability and~     safety of a continuous 24-month intake of celecoxib 200 mg QD versus placebo in subjects with~     OA of the hip.~   "
258742|NCT00163228|"~     In this study, a functional evaluation of total knee arthroplasty (TKA) patients is~     performed. The patients are measured prior to surgery and 6 and 12 months after surgery. The~     measurements consist of questionnaires and rising from a chair. Also, two types of TKA are~     functionally evaluated. At last, the TKA group will be compared to a THP group.~   "
258743|NCT00163215|"~     To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in~     standard deviation (SD) after 3 years will be compared to growth rate before the start of GH~     treatment.~   "
259550|NCT00152477|"~     A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour~     effects (part 2), of CDP791 combined with carboplatin and paclitaxel.~   "
258746|NCT00163176|"~     Tumor cell proliferation and repopulation contribute to resistance to radiotherapy in head~     and neck cancer. Up to now, this characteristic is mostly assessed using biopsies acquired~     during inspection under general anaesthesia before treatment.~      18F-FLT-PET (positron emission tomography) is a non-invasive imaging method showing areas of~     active proliferation. The aim of this study is to assess the value of the functional~     information gained by 18F-FLT-PET for radiotherapy planning and early tumor response~     assessment.~      Prior to radiotherapy, a planning CT-scan and a 18F-FLT-PET scan are acquired. After~     approximately two weeks of radiotherapy a further PET scan is obtained.~   "
258747|NCT00163163|"~     To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid~     intima-media thickness in postmenopausal women with moderate hypercholesterolemia.~   "
258748|NCT00163150|"~     The main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3~     months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients.~   "
258749|NCT00163137|"~     To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60~     mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.~   "
258750|NCT00163124|"~     There are a variety of treatment approaches used by the chiropractic profession. Some of~     these require forceful joint manipulation and some do not. This study is designed to compare~     outcomes of two such techniques that are common to chiropractic practice. The hypothesis is~     that there is no difference between forceful and non-forceful approaches to treatment.~   "
258751|NCT00163111|"~     This is a study to investigate the safety and efficacy of voriconazole for the treatment of~     candidemia in critically ill non-neutropenic patients~   "
258752|NCT00163098|"~     A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance~     in patients with COPD~   "
258753|NCT00163085|"~     To determine the effects of the NMDA antagonist, CP-101,606, in subjects with Parkinson's~     Disease~   "
258754|NCT00163072|"~     Rationale: Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the~     palliative treatment of breast and endometrial carcinoma. It is also commonly used as an~     appetite stimulant, particularly in HIV and cancer patients with poor appetite from their~     primary disease and/or their therapy. Megace is well absorbed orally, however, many patients,~     particularly younger ones have difficulty taking oral medications. Transdermal progestins are~     available and are FDA approved. For example, Ortho EvraTM is a transdermal contraceptive~     patch containing an estrogen (ethinyl estradiol) and a progestin (norelgestromin).~      Key Objectives: Compare the pharmacokinetics of orally administered vs. transdermal Megace~     and determine if there are any local side effects of the transdermal route.~   "
258755|NCT00163059|"~     To determine if the NMDA antagonist, CP-101,606, is effective for depression~   "
258756|NCT00163046|"~     The purpose of this study is to to assess the effect of gabapentin compared to placebo on~     sleep, using polysomnography along with subjective sleep assessments, in subjects with~     transient insomnia induced by a sleep phase advance.~   "
258757|NCT00163033|"~     Estetrol is a natural compound that is produced by the fetus during fetal life and circulates~     in the unborn child and the mother. It is an estrogenic compound. In this study the safety~     and tolerability of 28 days of the oral administration of estetrol in healthy postmenopausal~     women are investigated. In addition, the pharmacokinetics and some pharmacodynamic parameters~     are studied. The lowest dose of 2 mg estetrol is directly compared with 2 mg estradiol.~   "
258758|NCT00163020|"~     Hypothesis: Among women with twin or triplet pregnancies, weekly injections of~     17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will~     reduce neonatal morbidity by reducing the rate of preterm delivery.~      This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus~     placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk~     factor for preterm birth. The two risk factors to be studied are:~        1. Twin pregnancy~        2. Triplet pregnancy~   "
258759|NCT00163007|"~     Prospective, short-term studies in patients admitted for acute stroke have shown an increased~     risk of infections, bedsores, impaired functional outcome, slower rate of recovery, poorer~     rehabilitation potential and higher mortality in patients with a poor nutritional status. In~     hospitals without routine nutritional assessment and individual nutrition management plans,~     the risk of patients developing malnutrition may be increased. In this study, patients~     admitted for acute stroke are randomised into either receiving nutritional therapy derived~     from estimated individual nutritional intake and nutritional needs, or nutritional therapy~     based on routine care without routine assessment of nutritional status, intake, or needs. The~     primary outcome measure is the percentage of patients with weight loss ≥ 5 % at three month~     follow-up.~   "
258760|NCT00162994|"~     The purpose of this study is to find out if young children have more benefit of the~     combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent~     otitis media.~   "
258761|NCT00162981|"~     The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive~     therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2~     to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at~     approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be~     randomly assigned to either a low dose or a high dose. The study will include a baseline~     period, a titration period and a maintenance period. After the maintenance period, subjects~     will either continue into an open-label extension study or enter the taper period with a~     final visit 1 week after the last dose.~   "
258762|NCT00162968|"~     Many people with polyneuropathy suffer from pain which is difficult to treat. Escitalopram is~     a relatively new drug used in the treatment of depression. Escitalopram’s action mechanism on~     the brain suggests that escitalopram also may have an effect on neuropathic pain. This study~     will test the efficacy of escitalopram in patients with painful polyneuropathy.~   "
258763|NCT00162955|"~     The purpose of this study is to assess the protective effect of Valsartan on chronic~     cardiotoxicity induced by CHOP.~   "
258764|NCT00162942|"~     The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn~     Apheresis System as a treatment for the signs and symptoms of Crohn's disease.~   "
260384|NCT00141440|"~     The investigators' aim is to study the effect of cycling off criteria during pressure support~     ventilation in COPD patients at two levels of PEEP and PSV.~   "
258765|NCT00162929|"~     The purpose of this study is to determine the maximum tolerated dose and/or maximum~     attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an~     adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.~   "
258766|NCT00162916|"~     The purpose of the study is to explore to what extent continuing the antidepressant~     medication citalopram (Celexa), after depression has responded to treatment, helps prevent~     the return of depressive symptoms in patients with recent traumatic brain injury (TBI).~   "
258767|NCT00162903|"~     BACKGROUND Patent ductus arteriosus (PDA) is a frequent clinical event in preterm infant. The~     cardiopulmonary functions of these preterm babies may be adversely affected by the patency of~     ductus arteriosus. Ductal tissues are sensitive to the constricting effect of endothelin-1~     and the dilating effect of prostaglandins, inflammatory mediators, and concentration of~     oxygen.~      OBJECTIVE To examine the role of endogenous nitric oxide (NO) and endothelin-1 (ET-1) in the~     pathogenesis of patent ductus arteriosus of the preterm infants. We hypothesize that the~     patency of ductus arterious in preterm infants is probably due to inappropriate production of~     endogenous nitric oxide and the interaction with various inflammatory mediators and~     prostaglandins, which is different from those of term infants. In addition, the secretion of~     endothelin is probably decreased. The purpose of this study is to monitor the changes of~     these substance sequentially, and to evaluate the relationship among endothelin-1, endogenous~     nitric oxide, and inflammatory mediators in the pathophysiology of patent ductus arteriosus~     in preterm infants.~      METHODS AND MATERIALS~        1. Inclusion criteria:~             1. Preterm infants with gestational age less than 32 weeks or birth weight less than~               2000 gm.~             2. Informed consent~        2. Numbers of study population:~           With 80-100 evaluable infants (40-50 patients in PDA and non-PDA groups, respectively)~        3. Blood sample, collecting on day 1,3,7 after regular echocardiographic evaluation, is~          assessed for inflammatory mediator (IL-8, IL-10), nitric oxide metabolites (nitrite and~          nitrate), endothelin-1, and cGMP~        4. Statistical analysis: Student t-test testing the differences of clinical data, Wilcoxon~          signed rank test for comparing data obtained between the PDA and non-PDA patients, the~          PDA patients before and after intravenous indomethacin, and those who are responsive or~          refractory to the therapy.~   "
258768|NCT00162890|"~     The specific aims are as follows:~        1. To investigate the degree of impairment, such as range, proprioception, sensation, and~          electromyography (EMG) pattern of healthy, older subjects.~        2. To investigate the relationship of these impairment measurements, the functional outcome~          and disability in patients with cervical spondylosis.~        3. To develop an exercise program with an emphasis on proprioception, stability and~          coordination for patients with neck-shoulder complaints to decrease the impairment and~          increase the functions of patients.~   "
258769|NCT00162877|"~     The objective of this trial is to find the rationale and the optimal dose and duration of~     regimen for the eradication of H. pylori infection using different proton pump inhibitors.~   "
258770|NCT00162864|"~     This randomized, double-blind, placebo-controlled trial assessed the efficacy of montelukast~     in the treatment of adults ≥50 years of age with persistent asthma and/or COPD. Primary~     outcomes included forced expiratory volume in one-second (FEV1) and daytime asthma symptoms~     scores. Nocturnal symptoms, asthma control, health-related quality of life, peak flow~     measurements, and health care utilization were also assessed as secondary outcomes.~     Participants were recruited from the Kaiser Permanente Northwest member population. One~     hundred forty-nine subjects were randomized to treatment with montelukast (10 mg per day) or~     placebo, and were followed for a six-week period. No differences in lung function measures,~     health-related quality of life, health care utilization, and asthma symptom scores were~     observed; however, the montelukast group had slightly improved asthma control scores compared~     to the placebo group.~   "
258771|NCT00162851|"~     This is a Phase II trial to study the safety and tolerability of subcutaneous alemtuzumab~     administered without dose escalation to patients with advanced B-cell chronic lymphocytic~     leukemia (B-CLL).~   "
258772|NCT00162838|"~     Periodontitis develops due to subgingival infection with specific microbial pathogen from~     dental plaque. The bacteria can activate immunoinflammatory mechanisms within the local~     periodontal tissues that lead to destruction of collagen and alveolar bone. Human gingiva~     contains Langerhans and connective tissue dendritic cells. Signals from periodontal pathogen~     can induce dendritic cells to maturation,rapidly increasing surface expression of MHC class~     II, costimulatory molecules, and secrete proinflammatory cytokines to regulate adaptive T~     cell immune response. Studies on cytokines have led to controversy about different T cell~     subsets associated with the progression of periodontitis. Seymour proposed that~     susceptibility to periodontal disease progression involve a predominantly Th2 response while~     Ebersole speculated that Th2 cells providing protective function. It is possible that a given~     pathogen may produce different maturation signals by activating DCs induce a given type of~     immune response. In this study, we observed the profiles and amounts of cytokine production~     of DCs stimulated with P. gingivalis and T. forsythensis compared with E. coli, to see~     whether the periodontal pathogens may induce different response of dendritic cells in the~     innate immunity.~   "
258773|NCT00162825|"~     Role of CD7 in skin inflammation and psoriasis~   "
258774|NCT00162812|"~     prospective evaluation of topoisomerase II alpha gene amplification and protein~     overexpression as markers predicting the efficacy of epirubicin in the primary treatment of~     breast cancer patients.~   "
258775|NCT00162799|"~     To explore the efficacy of triflusal in the attenuation of insulin resistance in human~     obesity. Triflusal is a salicylate compound approved in several countries as antithrombotic~     agent (antiplatelet). The hypothesis is to explore if there is a reduction of obesity-induced~     insulin resistance by triflusal.~   "
258776|NCT00162786|"~     The primary objective of this study is to measure and compare the acute effects of rupatadine~     10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers’~     performance on a standard over-the-road driving test and a car-following test.~   "
258777|NCT00162773|"~     The purpose of this study is to find out if omalizumab is effective in treating non-allergic~     asthma. The US Food and Drug Administration has approved the use of omalizumab to treat~     moderate to severe allergic asthma.~   "
258778|NCT00162760|"~     The goal of this study is to determine whether thalidomide can stop the progression of~     fibrosis in IPF.~      The primary objective of this study is to determine the safety, feasibility and efficacy of~     400 mg of thalidomide administered daily for one year in patients with idiopathic pulmonary~     fibrosis (IPF) who have failed or are not candidates for treatment with corticosteroids~     and/or cytotoxic drugs.~      The study population will consist of patients with biopsy-proven moderate to severe IPF who~     have failed or are not candidates for standard therapy with corticosteroids and/or cytotoxic~     drugs.~   "
258779|NCT00162747|"~     The purpose of this study is to determine how to best take care of the skin of preterm~     infants in order to prevent infections through the skin.~   "
258780|NCT00162734|"~     This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of~     two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily~     for 48 weeks and no treatment in patients chronically infected with hepatitis C who are~     nonresponders to previous pegylated interferon alfa plus ribavirin therapy and participated~     during at least 24 weeks of no treatment in IRHC-001.~      At the time of randomization into IRHC-001, the no treatment arm patients will be~     concurrently randomized in a 1:1 ration to receive Interferon Alfacon-1 (9 or 15 µg) +~     Ribavirin (both administered daily) or no treatment for up to 48 weeks. Patients will not be~     eligible for consideration to receive treatment in IRHC-002 until they have completed a~     minimum of 24 weeks of participation in IRHC-001.~      The protocol and informed consent form that will be used must be approved by the~     Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the~     study is initiated.~   "
258781|NCT00162721|"~     This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant~     radiotherapy in the treatment of non-metastatic uterine sarcomas.~   "
258782|NCT00162708|"~     Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be~     two possibilities for improving efficacy of radiotherapy in locally advanced head and neck~     carcinomas. In this multicentric study, we tested the hypothesis that accelerated~     radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU,~     aiming to improve both local control and on distant metastases as compared to very~     accelerated radiotherapy.~   "
258783|NCT00162695|"~     Objective of the study objectives was to explore survival advantage for an intensified~     chemotherapy strategy in a randomised trial.~      IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin,~     epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g~     (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was~     determined according to site and / or response to chemotherapy ± surgery.~      The study was powered to detect 10% difference in 3 year OS.~   "
258784|NCT00162682|"~     The purpose of this study is to determine if a decision to switch to a subsequent~     antiretroviral regimen based upon the CD4 cell count rather than the standard switching~     strategy based on viral load could ensure the same immunological and clinical outcome and~     preserve future treatment options in AIDS patients~   "
258785|NCT00162669|"~     Primary liver cancer (hepatocellular carcinoma) is the fifth most common malignant disorder,~     with an increasing incidence in Europe and the USA as a result of the high prevalence of~     hepatitis C. Most patients are not suitable for potentially curative treatment. There is no~     standard palliative treatment for patients with advanced hepatocellular carcinoma (HCC), as~     no drug has been demonstrated to be efficient in this disease in terms of survival. The use~     of anti-vascular agents might be a promising approach in view of the highly vascular nature~     of this tumor. The aim of this phase II trial is to evaluate the potential benefit of~     bevacizumab in terms of disease control rate, progression-free and overall survival in adult~     patients with advanced primary liver cancer. Bevacizumab is an angiogenesis inhibitor already~     successfully used in patients with colorectal and renal cancers.~   "
258786|NCT00162656|"~     This is an international trial conducted by three cooperative groups: SFOP (France, Belgium,~     Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature~     B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and~     receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and~     C) test whether reduced therapy is equivalent to standard intensive therapy (LMB-89 B and~     C) in terms of event free survival. The reason for the modification is to reduce the long~     term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In~     group B, the modifications of treatment consists of a reduction of cyclophosphamide in~     COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a~     reduction of the doses in the CYVE courses and the elimination of the last 3 courses of~     maintenance treatment~   "
258787|NCT00162643|"~     Ritonavir boosted protease inhibitor based therapy will have equivalent antiviral efficacy~     over 48 weeks compared to NNRTI based therapy in patients who are antiretroviral therapy~     naïve and initiate therapy with CD4 counts ≤ 200/mm3.~   "
258788|NCT00162630|"~     To evaluate the analgesic potential of an neural blockade (Fascia iliaca compartment) with~     local anaesthetics in patients with hip fracture immediately after arrival in the emergency~     department.~   "
258789|NCT00162617|"~     To examine the effect of two different transfusion regimens on rehabilitation after hip~     fracture surgery.~   "
258790|NCT00162604|"~     Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or~     elderly women. The number of operations for vaginal repair is increasing in Denmark, but~     there is no consensus or evidence found about the efficiency of prophylactic antibiotics~     intraoperatively concerning postoperative infections.~      The objective of this randomized, controlled trial is to investigate the significance of~     prophylactic antibiotic treatment in vaginal repair operations.~   "
258791|NCT00162591|"~     The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral~     index variation during a nociceptive stimuli.~   "
258792|NCT00162578|"~     Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal~     meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality~     and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of~     dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely~     observational manner, we thought to measure blood and CSF concentrations of vancomycin in~     adult patients with pneumococcal meningitis, treated with vancomycin, third-generation~     cephalosporin and dexamethasone.~   "
258793|NCT00162565|"~     The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker~     continuation compared to its interruption in patients with congestive heart failure who are~     treated by a beta-blocker and present with an episode of heart failure worsening with~     pulmonary oedema requiring hospital admission.~      162 patients will be randomized in cardiology centers in France. Clinical status (primary~     endpoint) will be evaluated with a standardized questionnaire 3 days after hospital~     admission.~   "
258823|NCT00162175|"~     A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the~     Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type~     2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.~   "
258794|NCT00162552|"~     In patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be~     responsible of severe complications and death. Thus, the prevention of cytokine production~     should prevent complications and mortality.~      The aim of this study is to study the 2 months survival rate in patients with severe~     cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6~     month mortality, the proportion of transplanted patients, the occurrence of complications~     (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding),~     plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a~     multicenter double blind randomized trial with a placebo.~      All adult patients with severe cirrhosis might be randomized after written consent. Patients~     with severe carcinoma, intolerance or contraindication to pentoxifylline will not be~     included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three~     hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in~     a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.~   "
258795|NCT00162539|"~     Mother with severe Iodine deficiency are more likely to have neonates with further poor~     mental development . In order to select population which could benefit from iodine~     supplementation, ioduria has been tested but cannot be routinely practised. Strong background~     data suggest that iodine status could be antenatally correlated with foetal thyroid volume.~     The aim of that study is to examine correlation between these two parameter in a population~     of 130 healthy pregnant women.~   "
258796|NCT00162526|"~     The present protocol is an attempt to prevent/treat mucositis in highly susceptible patients~     subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses~     of chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the~     Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of~     transplant recipients which subjects the patients to the risk of sepsis, need for parenteral~     nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E~     based formulations with placebo.~   "
258797|NCT00162513|"~     Donors with CM will be solicited from a waiting list of patients awaiting BMT from the~     waiting list of MUD searches.~      Maximally matched donor will be searched for each eligible CML patient with a goal in mind to~     find other patients with CML that share both class I and class II determinants. Sharing of~     one class I II will be considered eligible for participation in the study. Peripheral blood~     and PBMC from the donors will be isolated, washed and irradiated.~      The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals~     for a total of 6 injections.~   "
258798|NCT00162500|"~     Rationale:~      ImMucin was shown to be able to induce a robust cellular immune response mediated via both~     CD4+ and CD8+ T lymphocytes and therefore, could potentially be more effective in the~     majority of the target population.~      Purpose:~      The purpose of this study is to evaluate the safety and initial efficacy of ImMucin, a novel~     peptide vaccine in metastatic tumors expressing the MUC-1 Tumor Associated Antigen (TAA).~   "
258799|NCT00162487|"~     Several studies have indicated that albuterol administered either intravenously or by~     inhalation can significantly reduce plasma potassium concentration in patients suffering from~     chronic renal failure.In conjunction with the decrease in potassium concentration a modest~     rise in glucose concentration is usually noted. These metabolic effects are characterized by~     rapid onset occurring as early as 3-5 minutes following salbutamol administration and lasting~     for at least 1 hour.~      The role played by ß2AR polymorphisms in determining the bronchial and vascular response to~     ß2AR agonist drugs, have been confirmed by several studies.~      The purpose of the present study is to examine possible causal relationships between~     genetically based alteration in the structure of ß2AR and the metabolic effects of inhaled~     albuterol.~   "
258800|NCT00162474|"~     The anticoagulant effect of warfarin varies greatly among individuals. Some of this~     variability is attributed to differences in the activity of CYP2C9, the predominant enzyme~     involved in the metabolism of S-warfarin.~      The present study is designed to define the differences in warfarin metabolism among healthy~     individuals carrying different CYP2C9 genotypes. In addition, the study will define the~     correlation between the phenytoin metabolic ratio, a marker of CYP2C9 activity in vivo, and~     warfarin metabolism.~   "
258801|NCT00162461|"~     The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its~     metabolism. This metabolic pathway is mediated by the activity of CYP2C9.~      The purpose of the present study is:~        1. To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity~        2. To correlate phenytoin metabolic ratio with CYP2C9 genotype~        3. To study the frequency distribution of CYP2C9 activity in-vivo~   "
258802|NCT00162448|"~     Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of~     BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators~   "
258803|NCT00162435|"~     The response to warfarin varies greatly among individuals. Some of this variability can be~     ascribed to genetic polymorphisms in the gene encoding for CYP2C9, the enzyme mediating the~     metabolism of S warfarin. In addition genetic polymorphism in other genes (i.e. VKORC1,~     factor VII) have been shown to account for some of the variability in the response to~     warfarin irrespective of CYP2C9.The present study has several segments:~        1. Evaluation of the relationship between genetic polymorphisms in the genes encoding for~          CYP2C9, VKORC1 and factor VII and warfarin maintenance dose at steady state. This study~          is a confirmation of previous data in our own population.~        2. Evaluation of relationship between genetic polymorphisms in the genes encoding for~          CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.~        3. Testing the hypothesis that warfarin loading based on the individual's combined CYP2C9,~          VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse~          drug effects.~   "
258824|NCT00162149|"~     Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the~     pharmacokinetics of atazanavir in HIV-infected individuals.~   "
258825|NCT00162136|"~     The purpose of this study is to determine the dose limiting toxicities, minimum tolerated~     dose and recommended dose for Phase II studies.~   "
258826|NCT00162123|"~     The purpose of this study was to evaluate the continued use of ipilimumab in patients who had~     reinduction at the time of disease progression or to continue maintenance treatment. In~     addition, this study will continue to follow patients who have taken ipilimumab, but who are~     not eligible for maintenance or reinduction therapy.~   "
258804|NCT00162422|"~     The role played by ß2AR polymorphisms in determining the bronchial response to ß2AR agonist~     drugs, has been confirmed by several studies.~      The purpose of the present study is to examine possible causal relationships between~     genetically based alteration in the structure of ß2AR and drug responsiveness. An ex-vivo~     model (organ bath technique) will be used to investigate association between polymorphisms in~     the coding region of ß2AR and the response of bronchial rings derived from human lung tissue~     to the respective agonists (i.e. salbutamol).~      In the second part of the study the same bronchial rings will be incubated for 24 hours in a~     solution containing fixed concentration of albuterol. A second dose response curve for rising~     concentrations of albuterol will be constructed and a relationship between β2 genetic~     polymorphisms and the extent of desensitization to albuterol will be investigated.~      In addition, through specifically designed receptor binding assay the bronchial tissue will~     be used to define the affinity (Kd) and expression (Vmax) of the ß2 receptor. These data will~     enable to enhance our understanding regarding the mechanism responsible for the association~     noted between ß2AR polymorphism and altered drug effect.~   "
258805|NCT00162409|"~     Folic acid supplementation has been shown previously to be associated with enhanced formation~     of p-HPPH from phenytoin, a metabolic pathway which is predominantly mediated through the~     activity of CYP2C9.~      The metabolism of S warfarin, the more active enantiomer of warfarin, is also mediated~     predominantly through the activity of CYP2C9.~      The purpose of the present study was to examine the relationship between folic acid~     concentration and warfarin pharmacokinetic as well as warfarin dose requirement among~     patients treated by warfarin. In addition the effect of folic acid supplementation (5 mg/d)~     for 3 weeks on warfarin pharmacokinetic and warfarin dose requirement will be evaluated in~     the second part of the study.~   "
258806|NCT00162396|"~     The response to salbutamol varies greatly among individuals. Data from previous studies~     indicate that some of the variability is accounted for by genetic polymorphisms in the gene~     encoding for the adrenoceptor subtype β2. The current study was designed to evaluate~     variability in the response to salbutamol among recently diagnosed patients who have not been~     treated by β2 agonists or corticosteroids.~      Lung function tests will be performed prior to and following a single dose administration of~     salbutamol through inhalation. Additional pharmacodynamic indices will be monitored including~     pulse and blood pressure. Three samples of plasma will be drawn for the evaluation of~     salbutamol plasma concentration.~   "
258807|NCT00162383|"~     The ability to metabolize drugs varies greatly among individuals. Major fraction of this~     variability lies in genetic polymorphisms of genes encoding for enzymes responsible for both~     phase I and phase II reactions.~      The purpose of this study ws to evaluate the phenotypic activity and the frequency of genetic~     polymorphisms in different phase II and phase I enzymes among various populations residing in~     Israel.~   "
258808|NCT00162370|"~     The study is designed to see if stress echocardiography can be used as a screening exam in~     peri-, or post-menopausal women with a risk of developing of coronary artery disease and~     experiencing future cardiac events.~   "
258809|NCT00162357|"~     The purpose of this clinical research study is determine if patients with diabetes that have~     undergone previous opening of a heart blockage may have a blockage that is not causing any~     symptoms that may be detected by imaging with Cardiolite.~   "
258810|NCT00162344|"~     The study is designed to see if stress heart imaging can be used as a screening exam in~     patients with diabetes and risk factors of developing of coronary artery disease and~     experiencing future cardiac events.~   "
258811|NCT00162331|"~     The purpose of this clinical study is to learn if there are any changes in how blood gets to~     your heart muscle and if your heart size changed after your heart attack.~   "
258812|NCT00162318|"~     The purpose of this study is to find a safe and effective dose of Erbitux and Iressa for~     subject with non small cell lung cancer.~   "
258813|NCT00162305|"~     The purpose of this clinical research study is to assess the safety of, exposure to, and~     biological effects of BMS-512148 in stable Type 2 diabetic subjects~   "
258814|NCT00162292|"~     The purpose of this clinical research study is to learn if it is safe for rheumatoid~     arthritis patients to take BMS-582949 along with methotrexate.~   "
258815|NCT00162279|"~     The Study was designed to look at the safety and efficacy of abatacept in combination with~     etanercept.~   "
258816|NCT00162266|"~     This study was conducted to assess the safety and tolerability of Abatacept combined with~     Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives~     were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept~     combined with Methotrexate.~   "
258817|NCT00162253|"~     The purpose of this clinical research study is to learn if BMS-587101 is effective on the~     treatment of Moderate to Severe Psoriasis. The safety of this treatment will also be studied.~   "
258818|NCT00162240|"~     A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the~     Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type~     2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone~   "
258819|NCT00162227|"~     This study is being conducted to assess the safety and tolerability of an oral liquid~     solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected~     children between the ages 3-16 who are failing or intolerant of current antiretroviral~     regimen and who are unable to swallow Sustiva capsules.~   "
258820|NCT00162214|"~     The purpose of Segment 1 of the study is to determine the effect of ketoconazole on~     dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in~     patients with advanced solid tumors.~   "
258821|NCT00162201|"~     Study to assess changes in synovial tissue before and after treatment with Abatacept in~     subjects with RA who remained on their background disease modifying anti-arthritis~     medications but who have failed previous therapy with anti-TNF (tumor necrosing~     factor)blocking agents.~   "
258822|NCT00162188|"~     This study is being conducted to assess the safety and tolerability of an oral liquid~     solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected~     children between the ages of 3-16 who are failing or intolerant of their current~     antiretroviral regimen and who are unable to swallow Sustiva capsules.~   "
260518|NCT00139672|"~     The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of~     abdominal pain/discomfort associated with irritable bowel disease.~   "
258828|NCT00162097|"~     The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz~     (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable~     antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or~     normal hepatic function.~   "
258829|NCT00162084|"~     The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT~     at detecting blockages in heart arteries, and to determine if it will have fewer side effects~   "
258830|NCT00162071|"~     The primary purpose of this study is to determine the optimal time for myocardial perfusion~     imaging with Technetium Tc99m Sestamibi following the administration of BMS068645. The safety~     of BMS068645 will also be studied.~   "
258831|NCT00162058|"~     To determine the optimal dose of DMP 115 to image liver lesions and to assess whether~     contrast can improve the detection of focal liver lesions.~   "
258832|NCT00162045|"~     The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and~     safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.~   "
258833|NCT00162032|"~     Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging~     (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of~     developing cardiac events.~   "
258834|NCT00162019|"~     The purpose of this study is to evaluate whether IMMUNATE S/D is effective and safe in the~     treatment of hemophilia A patients. The study consists of 3 parts: Part 1 is a~     pharmacokinetic comparison of IMMUNATE S/D and its predecessor IMMUNATE. Part 2 is an~     evaluation of efficacy and safety of IMMUNATE S/D. Part 3 is a pharmacokinetic study of~     IMMUNATE S/D.~   "
258835|NCT00162006|"~     The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR~     (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic~     idiopathic thrombocytopenic purpura.~   "
258836|NCT00161993|"~     The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune~     Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with~     primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are~     treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects~     receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product;~     for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.~   "
258837|NCT00161980|"~     This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is~     superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing~     the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph~     node dissection with two separate incisions.~   "
258838|NCT00161967|"~     The purpose of this study is to assess the seropersistence of TBE antibodies in children and~     adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34~     months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations~     during the predecessor study 209), as well as the immune response to a booster vaccination~     with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third~     vaccination (in Study 209).~      Protocol amendment of October 2006: The study has been prolonged for children and adolescents~     who still showed highly positive TBE virus antibody concentrations at approximately 3 years~     after the third vaccination and therefore did not receive a booster vaccination at this time~     point. Further follow-up of TBE antibody persistence is now included for these subjects at 46~     and 58 months after the third vaccination (in Study 209), as well as a booster vaccination~     offered at either 48 or 60 months after the third vaccination (in Study 209), depending on~     individual TBE antibody levels.~   "
258839|NCT00161954|"~     The objective of this study is to establish the earliest time point at which vaccines are~     expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using~     a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.~   "
258840|NCT00161941|"~     The primary aim of the study is to show that the antibody response to hepatitis B, acellular~     pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with Hexavac®~     is not influenced by the concomitant administration of NeisVac-C.~   "
258841|NCT00161928|"~     The primary aim of the study is to show that NeisVac-C does not influence the seroconversion~     rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP)~     vaccines in infants.~   "
258842|NCT00161915|"~     The purpose of this study was to assess whether endoscopic sclerotherapy with Fibrin Sealant~     was superior to ligature, with or without Polidocanol, in achieving hemostasis in bleeding~     esophageal varices and preventing rebleeding. Therapeutic success was defined as survival of~     the first seven days without clinically significant bleeding.~   "
258843|NCT00161902|"~     The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D~     is superior to standard treatment in reducing blood loss in subjects undergoing total hip~     replacement with cement-free hip prostheses.~   "
258844|NCT00161889|"~     The purpose of this study is to investigate the safety and immunogenicity of the third~     vaccination with one of three different concentrations of a TBE vaccine in all volunteers who~     completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety~     and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16~     years).~   "
258845|NCT00161876|"~     The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW~     in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME~     IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).~   "
258846|NCT00161863|"~     The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN~     NEW in healthy volunteers. The main criterion for investigation is the fever rate after the~     first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN~     NEW has been demonstrated in previous clinical studies in children; therefore, in the present~     study, immunogenicity was investigated in a subgroup only.~   "
258847|NCT00161850|"~     The purpose of this study is to investigate the safety and immunogenicity of the third~     vaccination with one of three different concentrations of a TBE vaccine in all subjects who~     completed two vaccinations in one of the three treatment groups of Baxter study 199 (a~     dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME~     IMMUN NEW in healthy subjects aged 1 to 6 years).~   "
258849|NCT00161824|"~     The purpose of this study is to assess the safety of a vaccination schedule consisting of two~     vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW~     (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with~     polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.~   "
258850|NCT00161811|"~     The objectives of the study are to assess the immunogenicity and safety among three different~     lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day~     180 after vaccination.~   "
258851|NCT00161798|"~     The purpose of this study is to investigate the safety and immunogenicity of three different~     concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.~   "
258852|NCT00161785|"~     The purpose of this study is to assess:~        -  TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN~          0.5ml by means of ELISA and neutralization test (NT).~        -  TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA~          and NT.~   "
258853|NCT00161772|"~     The purpose of this study is to investigate the safety and immunogenicity of three different~     concentrations of a TBE vaccine in healthy children aged 1 to 6 years.~   "
258854|NCT00161759|"~     The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as~     staples (the current standard of care) to achieve fixation of skin grafts and wound healing~     in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable~     treatment sites.~   "
258855|NCT00161746|"~     The purpose of this study is to evaluate a) whether the seroconversion rates in children are~     equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5~     mL, and b) whether there is a difference in terms of safety between the two products.~   "
258856|NCT00161733|"~     The objective of this study is to demonstrate equivalent hemostatic efficacy and safety~     between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery~     requiring cardiopulmonary bypass. If bleeding is still present after conventional surgical~     methods to achieve hemostasis have been applied FS VH S/D or Tisseel VH are applied.~     Achievement of hemostasis within 5 minutes is compared between the study groups.~   "
258857|NCT00161720|"~     This is a data collection study with the purpose of capturing dosing and treatment outcome~     data in subjects with severe congenital protein C deficiency who were treated with protein C~     concentrate under an Emergency Use Investigational New Drug Application (IND).~   "
258858|NCT00161707|"~     The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the~     short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha~     1-antitrypsin deficiency. The subjects are randomized to receive placebo or one of 4 doses of~     rAAT. The 4 doses are tested in a consecutive manner from lowest to highest.~   "
258859|NCT00161694|"~     The purpose of this study is to see if an oral sucrose solution can comfort premature infants~     during their necessary eye exams. The investigators believe that the use of this solution~     prior to the eye exams will lead to a decrease in pain as measured by a rise in heart rate~     and a fall in oxygen saturation. In addition this will lead to a decrease in events in the 12~     hours following examination. Events include episodes when the infants temporarily stop~     breathing, have a drop in their heart rates, or have a drop in their oxygen levels.~   "
258860|NCT00161681|"~     The purpose of this study is to determine whether LNG/EE is effective in the treatment of~     menstrual cycle related symptoms.~   "
258861|NCT00161668|"~     This study is designed to assess the safety of Mylotarg therapy in routine practice.~   "
258862|NCT00161655|"~     The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in~     plaque psoriasis patients, treated with the combination etanercept and methotrexate compared~     to etanercept alone.~   "
258863|NCT00161642|"~     The purpose of this study is to determine the safety, tolerability and maximum tolerated dose~     of CMD-193. Preliminary information about how a person's body processes CMD-193 and how~     CMD-193 affects tumors will also be collected.~   "
258864|NCT00161629|"~     To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal~     radius fractures. The key safety variables comprising this assessment are: 1) incidence of~     delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence~     of local neurovascular events (those involving the region under study [RUS]); and 4) rate of~     fracture displacement. The primary objective will be met if these outcomes in the active and~     placebo treatment groups are at least comparable to those of the SOC control group.~   "
258865|NCT00161616|"~     Demonstrate a larger proportion of subjects with healed fractures among subjects treated with~     InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed,~     locked intramedullary nailing alone.~   "
258866|NCT00161603|"~     To explore and illuminate the cultural, social, and psychological factors that either~     facilitate or serve as barriers to behavioral change in angioplasty patients. Through a~     series of open-ended questions we will explore and build a better understanding of how~     culturally different patient groups perceive heart disease and the difficulties in changing~     health behavior. In addition, we hope to better understand and anticipate barriers and issues~     that participants face in successfully changing their behaviors.~   "
258867|NCT00161590|"~     Primary Objective:~        -  To determine the toxicity profile and tolerability of alemtuzumab (Campath) when~          administered in combination with cyclophosphamide, doxorubicin, vincristine, and~          prednisone (CHOP) chemotherapy (C-CHOP) in patients with T-cell, null-cell and NK-cell~          lymphomas.~      Secondary Objectives:~        -  To evaluate response rate, overall survival, and disease-free survival in patients with~          T-cell, null-cell, and NK-cell lymphomas treated with Campath + CHOP chemotherapy.~        -  To assess the incidence of cytomegalovirus (CMV) reactivation in patients with these~          lymphomas treated with the Campath + CHOP combination.~        -  To determine features which might be predictive of resistance to treatment or predictive~          of relapse, including the absence of glycosylphosphatidylinositol (GPI)-linked proteins.~   "
258868|NCT00161577|"~     This study evaluates the safety and efficacy of ketorolac for post-operative pain management~     after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing~     the requirements for morphine during the (immediate) 24-hour post-operative period.~   "
258869|NCT00161564|"~     The purpose of this research study is to compare the efficacy and safety of higher doses of~     rituximab to a combination of standard doses of Rituxan + CVP (Cyclophosphamide, Vincristine,~     and Prednisone) in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP who did not~     respond to or relapsed after standard doses of rituximab.~   "
258870|NCT00161551|"~     The purpose of this study is to determine the incidence of atrial fibrillation and heart~     failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel~     algorithm to minimize ventricular pacing).~   "
258871|NCT00161538|"~     The purpose of this study is to determine which of 4 lead positions is most effective for~     pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial~     fibrillation.~   "
258872|NCT00161525|"~     Subretinal hemorrhage in the macula causes a significant loss of vision. This hemorrhage can~     be displaced by the use of a small volume of pure perfluorocarbon gas injected into the~     vitreous, which expands to a 40% gas bubble in the eye. When the patient gazes 40 to 60~     degree below the horizontal, the gas bubble covers the hemorrhage and gravity displaces it~     rapidly. This position of gaze is easier for the patient than the face down position~     traditionally recommended.A vector of gravity force tangential to the sclera brings about~     this displacement. The procedure can improve vision quickly, reduce unwanted degenerative~     changes in the macula because of the persistent macular hemorrhage and improves the chances~     of treating of the underlying cause for the subretinal hemorrhage by laser or other means.~   "
258873|NCT00161486|"~     The purpose of this research study is to understand the effects of testosterone on the~     prostate. This knowledge will be used to help in the development of a safe male hormonal~     contraceptive and may impact the development of androgen replacement therapy in older men.~   "
258874|NCT00161473|"~     The purpose of this study is to see if a medication called prazosin is useful in the~     treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other~     types of dementia in late life.~   "
258875|NCT00161460|"~     The purpose of this study is to determine if a prototype colorectal cancer screening program~     with the services of a cancer prevention specialist will increase utilization of appropriate~     colorectal cancer screening tests.~   "
258876|NCT00161447|"~     The purpose of this research study is to help in the development of male contraception (birth~     control).~   "
258877|NCT00161434|"~     The primary objective of this research study is to assess if daily valacyclovir therapy for~     suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in~     individuals co-infected with both HSV-2 and HIV.~   "
258878|NCT00161421|"~     The purpose of this study is to test the how the body absorbs and processes new forms of oral~     testosterone. Information gained during the study may help develop better forms of~     testosterone therapy in the future.~      We will be administering three drugs. Dutasteride is FDA approved to treat prostate~     enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved~     for treatment of testicular insufficiency. They are being used in this study for off-label~     research purposes. This study will allow us to find out the effect of food on two~     formulations of testosterone taken by mouth, and the relative effect of food on testosterone~     absorption.~      Information from this study may be useful in treatment of men with low testosterone levels~     and the development of a male hormonal contraceptive.~   "
258879|NCT00161408|"~     The study is a randomized clinical trial investigating the efficacy of a comprehensive~     psychological intervention for the treatment of first episode schizophrenia~   "
258880|NCT00161395|"~     The purpose of this study is to determine how long it takes couples of normal fertility to~     get pregnant once they begin to try, and whether instruction in fertility awareness can~     decrease time to pregnancy in these couples.~   "
258881|NCT00161382|"~     This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention~     program for 7th and 8th grade middle school students.~   "
258882|NCT00161369|"~     Homocysteine (Hcy) and asymmetric dimethylarginine (ADMA) have recently been recognized as~     potential risk factors for atherosclerosis in the general population, and the metabolism of~     each of these substances seems to be closely related. This study investigates the association~     between these substances, and whether elevated serum levels of Hcy and ADMA would be related~     to a high risk of atherosclerosis and cardiovascular events in maintenance hemodialysis (HD)~     patients.~   "
258883|NCT00161356|"~     In this study we are trying to find out the amount of a drug called Ambisome in the liver,~     the blood, the bile and the fatty tissues of the body. This drug is approved for treatment of~     infections caused by fungus and is known to be effective against most of the fungal~     infections, which can happen after liver transplantation. By taking small pieces (less than~     quarter of a teaspoon) of liver and fat during the liver transplant operation, we can measure~     how much of the drug is concentrated in the liver. After that, we will measure the level of~     the drug in the blood and in the bile that comes out of a small tube which is inserted into~     the bile tube as a routine in all liver transplant patients. These measurements will be taken~     daily for a week and then weekly for another 3 weeks.~      We are inviting you to take part in this study in order to increase our knowledge of the~     behavior of this drug so that we can find the most effective treatment to prevent fungal~     infections in liver transplant patients.~   "
258884|NCT00161343|"~     In this study, an intervention is tested that is designed to reduced risky sexual behaviors~     in adolescent females. Study design:~        -  randomized, controlled study~        -  participants: 640 girls aged 15-19 years old~        -  length of follow-up: 1 year after the intervention is completed~      Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors~     in adolescent females as measured by:~        -  lower incidence of STI's at 6 and 12 months, as compared to baseline~        -  decreased incidence of risky sexual behaviors~        -  increased knowledge of the level of risk of certain behaviors~        -  increased knowledge of safer sexual behaviors that can prevention HIV infection~        -  increased motivation to reduce sexual risk~        -  increased behavioral skills to reduce risk of HIV infection~   "
258885|NCT00161330|"~     The main objectives of the study are~        1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a~          first episode of UTI~        2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram,~          voiding cystourethrogram, and renal scanning with technetium-99m-labeled~          dimercaptosuccinic acid)~   "
258886|NCT00161317|"~     The Living with Hope program was developed by the research team, a panel of experts and~     palliative patients and their families. The program was evaluated with 60 advanced cancer~     patients 60 years of age and older. Thirty received the program and 30 did not. After one~     week, those receiving the Living with Hope Program had higher hope and quality of life scores~     compared to those who did not. This suggests that the program is effective in increasing hope~     and quality of life for older palliative care patients with cancer.~   "
258887|NCT00161304|"~     The T-001 study is a placebo-controlled investigation of the effects of injectable~     testosterone replacement therapy on prostate tissues of aging men with low testosterone~     levels. The primary objectives of the study are to measure the changes in tissue hormones and~     other biomarkers in the prostate tissue specimens.~   "
258888|NCT00161291|"~     The purpose of this study is to determine pathological response to a maximum of 18 weeks of~     neoadjuvant therapy using a combination of letrozole and Bevacizumab in post-menopausal women~     with pathologically confirmed invasive ductal cancer or invasive lobular cancer of the breast~     whose tumors are hormone positive.~   "
258889|NCT00161278|"~     Patients who are at least 18 years of age and have a type of cancer known as advanced~     non-small cell lung cancer may be eligible for this study if they meet all of the~     inclusion/exclusion criteria.~      Background: The standard treatment for patients with advanced non-small cell cancer is~     chemotherapy. The two drug combination, carboplatin (Paraplatin) and paclitaxel (Taxol), is~     commonly used as the first treatment. Unfortunately, standard treatment with chemotherapy~     only shrinks the cancer in about 30% of patients that receive it. There is no way to predict~     who will or won't benefit from this treatment. The researchers at the University of Michigan~     would like to determine if the genes of the lung cancers in patients enrolled in this study~     will help predict whether or not the tumors shrink when exposed to standard chemotherapy. The~     goal is to find a set of lung cancer genes that will predict successful treatment with~     carboplatin and paclitaxel in patients with non-small cell lung cancer.~      The actual treatment, carboplatin and paclitaxel, involved in this study is not experimental.~     The experimental aspect of this study is the identification of predictors of response to~     treatment. To do this, it would require a sample of your cancer. If your initial surgery or~     biopsy was done at the University of Michigan, we may already have an adequate sample of your~     cancer that could be used for this research. In that case, we are asking for your permission~     to use this sample for this study. However, if you meet all eligibility criteria and agree to~     participate in this research study and an adequate sample is not available, you will need to~     undergo another biopsy procedure for us to obtain a sample of your cancer. Obtaining a tumor~     sample is the most crucial part of this research study.~   "
258890|NCT00161265|"~     This study is being performed so that tumor and blood samples from patients who will receive~     breast cancer treatment prior to surgery can be collected and stored for future research.~   "
258891|NCT00161252|"~     The widespread availability of screening coupled with high risks of over diagnosis, over~     treatment, and a rising risk of dying from competing causes of deaths pose a major challenge~     for prostate cancer patients and our health care system. Data on outcomes and identification~     of patients who are likely to benefit from therapies are urgently needed to empower patients~     and health professionals and to allocate limited health resources wisely. The long-term goal~     of this population-based study is to improve prostate cancer care for elderly patients. In~     2004, approximately thirty percent of the 230,110 new prostate cancer cases diagnosed will be~     in men over age 75. Elderly men have a high risk of being diagnosed with prostate cancer, but~     a relatively low risk of dying of this disease, and are often excluded from cancer trials.~     While the value of primary androgen deprivation for localized prostate cancer remains~     questionable, this treatment is widely used among elderly patients. Currently, there is~     insufficient outcomes data to guide treatment choices for elderly patients.The following are~     the key background considerations that provide the rationale for this proposed project:·~     Prostate cancer is prevalent among elderly men. · Over diagnosis and competing causes of~     death are important issues for elderly men with prostate cancer.· Androgen deprivation~     therapy (ADT) is being increasingly used as primary therapy among elderly patients with~     localized disease· There are insufficient outcomes data to support the use of primary~     androgen deprivation for non metastatic prostate cancer· Preliminary dataThe study population~     in this sub-project is a sub-sample of the large study (IRB # 5177 ) and the research methods~     are identical in both studies.~   "
258892|NCT00161239|"~     Peripheral T cell lymphoma and advanced cutaneous T cell lymphomas are aggressive and~     refractory diseases that are generally treated with chemotherapy. Despite current treatment~     modalities, only a subset of patients will be cured by the treatment. In this study, four~     chemotherapeutic agents (L-asparaginase, Methotrexate, Doxil, and Prednisone) will be~     administered in a combination regimen for patients with relapsed or refractory Peripheral~     and/or advanced cutaneous T cell lymphoma. Each one of these individual drugs have been shown~     to have activity to lymphomas. The objective of the study is to determine if the combination~     of these chemotherapy agents results in higher response and cure rates in this patient~     population. This will be a single institutional study which will included 32 patients in the~     Peripheral T cell lymphoma group and 32 patients in the Cutaneous T cell lymphoma group.~   "
258903|NCT00161096|"~     The purpose of this study is to investigate several aspects of chronic use of acid~     suppressing medication: dependence on maintenance therapy, the possibilities for on-demand~     use, and predictors (patient characteristics) for daily need, for on-demand use and for~     termination of chronic use.~   "
258904|NCT00161083|"~     We conduct a randomized, double-blind, placebo-controlled trial on effects of UDCA on biliary~     pain and complications in highly symptomatic gallstone patients scheduled for~     cholecystectomy. We also evaluate potential beneficial effects of impaired gallbladder~     motility~   "
258905|NCT00161070|"~     The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a~     combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment~     with aspirin alone after cerebral ischemia of arterial origin.~   "
258967|NCT00160264|"~     This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the~     efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to~     lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among~     postmenopausal women.~   "
258893|NCT00161226|"~     Endometrial (uterine) cancer affects over 40,000 women each year in the United States. At~     this time there are no medications to prevent endometrial cancer. Women who are heavy are at~     increased risk of this cancer. Progestins have been used to treat endometrial hyperplasia and~     cancer in women who wanted to retain their fertility or who were not surgical candidates.~     Oral progestins are associated with side effects such as weight gain, mood changes,~     headaches, and acne. A device called Mirena has a type of progesterone in it. Because it is~     placed directly in the uterus it can give a powerful amount of progestin with less side~     effects. In this project, we will enroll 44 women who are aged 40-50 and who have a body mass~     index (BMI) greater than 40. (BMI is a measure of obesity. Normal is less than 25.) They will~     be randomized to either observation or treatment. The women in the treatment group will have~     a levonorgestrel intrauterine system (Mirena, LNG-IUS) placed for one year. All of the women~     will have endometrial biopsies and blood work at the beginning and end of the study. All of~     the women will have an ultrasound at the beginning of the study. The information will then be~     used to assess whether or not the LNG-IUS will be an effective prevention agent. The women~     will be contacted once a year for 5 years to see if they have had endometrial hyperplasia or~     cancer. A special lab study called microarray will be used to see what genes are turned on or~     off in the uterine lining.~   "
258894|NCT00161213|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib~     mesylate works as first-line therapy in treating patients with locally advanced or metastatic~     pancreatic cancer.~   "
258895|NCT00161200|"~     In this project, we are trying to identify patients with the earliest signs of abnormality in~     the lining of the lower part of the food pipe (or esophagus) known as intestinal metaplasia~     (IM); also commonly called Barrett's esophagus or Barrett's Epithelium (BE). IM is sometimes~     difficult to diagnose by routine microscopic examination (called histology). We have~     developed a specific antibody, a protein called immunoglobulin that specifically reacts with~     another partner protein, if it exists. Using this marker antibody (called mAb Das-1) that has~     been patented (US patent #5,888,743), we have shown that this marker can detect the abnormal~     changes in the distal esophagus before it is evident by histology. IM usually develops in the~     face of long-term acid reflux from the stomach to the esophagus and causes the lining to~     change from the normal squamous type (like that of skin) to a type of lining normally seen in~     the small intestine and colon. A subgroup of patients with IM may, subsequently, develop~     histologically evident Barrett's Epithelium and a small percent of these patients may develop~     cancer of the esophagus. Thus, BE is considered as a pre-cancerous condition. We already have~     an ongoing IRB for the portion of the project involving taking biopsies and performing the~     antibody staining to identify patients that react with the antibody but histologically~     negative for BE.~   "
258896|NCT00161187|"~     RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may~     help the patient's immune system kill cancer cells.~      PURPOSE: This pilot study is looking at the side effects and how well irradiated donor~     lymphocyte infusion works in treating patients with relapsed or refractory hematologic cancer~     or solid tumor.~   "
258897|NCT00161174|"~     BACKGROUND:~      Evidence has emerged that patients cured with cisplatin-bleomycin chemotherapy from~     disseminated testicular cancer (TC) develop a large number of cardiovascular risk factors~     (CRF) several years later. Recently, we observed an increased incidence of cardiac events~     10-20 years after chemotherapy, possibly as a result of increased occurrence of CRF.~     Additional cardiovascular damage was observed after treatment: disturbed diastolic function~     of the left ventricle, microalbuminuria and increased endothelial damage parameters.~     Furthermore, a metabolic syndrome (syndrome X) with insulin-resistance, dyslipidemia,~     hypertension and endothelial damage was found in about one third of our cured patients. The~     investigators hypothesize that endothelial damage and metabolic changes caused by the~     bleomycin and cisplatin chemotherapy are the main causes for the observed increase in~     cardiovascular disease in these young cancer survivors. Genetic susceptibility may be an~     important determinant of individual risk of toxicity in individual patients.~      PURPOSE:~        1. To identify risk factors for cardiovascular disease (CVD) following testicular cancer.~        2. To obtain insight into the pathway(s) of CVD development, by examining whether clinical~          CVD following testicular cancer is associated with a preceding unfavorable~          cardiovascular risk factor profile and/or with treatment-related factors.~        3. To investigate genetic polymorphisms in pathogenetically important pathways that are~          potentially involved in the development of treatment related cardiovascular morbidity~          following testicular cancer.~      PATIENTS AND METHODS:~      Patients with non-seminomatous testicular cancer who have been uniformly treated with~     orchidectomy and cisplatin-bleomycin combination chemotherapy at the University Hospital~     Groningen, The Netherlands, since 1977 but before 2000 are eligible. 380 patients with~     non-seminomatous testicular cancer fulfill these criteria. A close routine follow-up of these~     patients after treatment has been done at the University Hospital Groningen. Clinical~     characteristics of these patients, treatment details including outcome and long-term~     follow-up are being registered systematically. From all patients who agree to participate~     assessment of their cardiovascular risk factors and the presence of subclinical~     cardiovascular damage will be performed by means of several measurement techniques. Also~     genomic DNA will be collected for studies on polymorphisms in pathogenetically important~     pathways. For the total cohort of patients several different late effects phenotypes of~     cardiovascular damage and cardiovascular risk factor patterns will be derived from the~     available data. These toxicity phenotypes will be used to select cases and controls from the~     total cohort to test candidate genetic polymorphisms on their association with occurrence of~     toxicity. The association of the different genetic polymorphisms with the toxicity phenotype~     will be estimated by comparing cases with different toxicity phenotypes with controls without~     that phenotype.~      POSSIBLE RESULTS This research will provide insight into the pathogenesis of cardiovascular~     disease after treatment for testicular cancer. The main outcome will be the possibility to~     select individually those patients who are likely to have an increased risk to encounter~     specific cardiovascular toxicity during or after chemotherapy treatment for TC. This will~     provide opportunities for the tailoring of potential toxic treatment and/or guide primary and~     secondary prevention strategies for serious side effects of chemotherapy treatment.~   "
258898|NCT00161161|"~     Attention Deficit Hyperactivity Disorder (ADHD) is a heritable psychiatric disorder with~     onset in childhood. Twin and adoption studies indicate that additive genetic factors explain~     up to 80% of the variance underlying susceptibility. The siblings of children with ADHD have~     a three- to fivefold increased risk of having ADHD compared to the siblings of healthy~     control subjects, and the risk is even greater for monozygotic twins with 50-80% concordance~     compared with up to 33% in dizygotic twins). As full siblings share on average 50% of their~     genes, even the unaffected siblings of children with ADHD would be expected to share some of~     the genes involved in the disorder. The neuroanatomical substrate of ADHD is becoming~     increasingly better defined by a growing body of evidence from imaging studies. Evidence from~     neuroimaging studies suggests that this disorder is associated with reductions in brain~     volume up to 5% in these children. In this protocol we collected MRI-scans from boys with~     ADHD and their unaffected siblings, as well as control subjects. In addition, cheekswabs were~     later collected for DNA analysis.~   "
258899|NCT00161148|"~     PSC is a progressive liver disease without effective medical treatment. There is often~     co-existent ulcerative colitis. Probiotics (bacterial food supplements) have been shown to~     benefit patients with ulcerative colitis. In the current protocol potential beneficial~     effects of probiotics on liver biochemistry and liver related symptoms as pruritus are being~     assessed in 12 PSC patients in a randomized controlled cross over study (3 months probiotics,~     1 one wash-out and 3 months placebo).~   "
258900|NCT00161135|"~     This study aims to investigate the overlap and differences between autism and MCDD as~     neuropsychiatric childhood disorders. MRI scans are acquired from subjects with autism,~     subjects with a diagnosis of MCDD and typically developing controls. Volumetric measure of~     various brain regions are compared between groups. We hypothesize that subjects with autism~     will have larger brains than controls, whereas subjects with MCDD will have smaller brains.~   "
258901|NCT00161122|"~     The PRIMAKid trial is a general practice based double-blind randomized placebo-controlled~     trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in~     pre-school children with recurrent respiratory tract infections. A target number of 660~     children aged 18-72 months with a history of two or more general practitioner attended~     episodes of RTI, are included. Exclusion criteria are diseases accompanied by a high risk of~     recurrent RTI and conditions chronically treated with corticosteroids. Over a period of 7 to~     22 months follow-up, the number of febrile RTI-episodes as primary outcome is assessed, and~     as secondary outcomes the severity and length of febrile RTI-episodes, medical visits /~     interventions, health-related quality of life and productivity loss of parents.~   "
258902|NCT00161109|"~     The purposes of this study are to:~        1. study the nature and longitudinal course of psychiatric symptoms in children with the~          22q11.2 deletion syndrome and~        2. identify genes that contribute to the occurrence of these symptoms.~   "
258906|NCT00161057|"~     In this study we, the investigators at UMC Utrecht, intend to investigate changes in brain~     activation patterns using functional magnetic resonance imaging (MRI), in patients suffering~     from schizophrenia who are medication naive or off medication, before using medication and~     after 8 weeks of medication. Patients will perform a working memory task, a language task and~     a motor task while lying in the scanner. We hypothesize that the efficiency of the working~     memory system is reduced and that the lateralization of language is diminished in these~     patients, and that these functions will normalize after treatment.~   "
258907|NCT00161044|"~     The purpose of this study is to see if galantamine is an effective agent for the treatment of~     the cognitive abnormalities, negative symptoms, and /or behavioral impairments seen in~     schizophrenia.~   "
258908|NCT00161031|"~     The purpose of this study is to:~        -  To examine wether adjunctive atomoxetine is more effective thank placebo for~          neuropsychological measures of reaction time, motor speed, psychomotor speed, sustained~          attention, learning and memory, working memory, and executive functioning. To determine~          the effect size of atomoxetine on these neuropsychological measures for follow-up~          studies.~        -  To determine if atomoxetine has short-term benefits for improving weight gain and other~          metabolic abnormalities associated with antipsychotics.~   "
258909|NCT00161018|"~     The purpose of this study is to:~        1. Evaluate the efficacy and safety of the new antipsychotics, quetiapine (300-500mg/day)~          and risperidone (3-4mg/day) compared to each other and to fluphenazine (10-15mg/day), a~          high potency typical antipsychotic in patients who meet the DSM IV criteria for~          schizophrenia.~        2. To evaluate the efficacy and safety of quetiapine (1200mg/day) in patients who have not~          responded to conventional and newer antipsychotics.~        3. To evaluate the effectiveness of quetiapine (300-500mg/day), and risperidone (3-5mg/day)~          compared to each other and fluphenazine (10-15mg/day) in the treatment of hostility and~          aggression in treatment-resistant schizophrenic patients.~        4. To evaluate the effectiveness of quetiapine (300-500mg/day) and risperidone (3-5mg/day)~          compared to each other and fluphenazine (10-15mg/day) on rates of discharge, quality of~          life, and independent living skills.~        5. To assess prolactin levels and to evaluate any relationship with sexual dysfunction and~          menstrual irregularities.~        6. To evaluate the possible differential impact of treatment conditions on cognitive~          functioning including measures of attention, motor speed, problem solving, verbal and~          visual memory, and verbal processing speed.~        7. To measure changes in weight and health consequences associated with weight changes.~   "
258910|NCT00161005|"~     In the district areas of Norway patients with acute myocardial infarction with ST-elevation,~     are treated with thrombolysis. An increasing part of them receives thrombolysis before~     arrival to the local hospital.Usually these patients have been sent to an invasive center if~     thrombolysis fails or the patient gets ischemic symptoms during the stay.~      This study will compare this strategy against immediate transportation to an invasive center~     after the patient has received thrombolysis.~   "
258911|NCT00160992|"~     Patients with advanced stage melanoma who underwent vaccination with the Melan-A/MART-1~     peptide and who display detectable levels of Melan-A specific CD8+ T cells in peripheral~     blood are eligible for this trial. After collecting and freezing of these tumor specific T~     cells via apheresis, patients undergo a single cycle of immunosuppressive chemotherapy. 3~     days after, cells are reinfused and peptide vaccination continued. The aim of this~     immunotherapy protocol is to boost tumor specific T cells during the immune recovery period~     in order to reinforce the patients' immune response against the tumor.~   "
258912|NCT00160979|"~     Prostate cancer is now the most commonly diagnosed tumor among men in the United States. Most~     patients have tumors that are confined to the prostate gland at diagnosis and are suitable~     for treatment with surgery or radiotherapy (RT) that is aimed at curing the disease.~     Nevertheless, despite recent improvements in these treatments, a large number of men continue~     to die of prostate cancer. These patients often have spread of tumor to other areas of the~     body, and are treated with hormones that produce initial tumor shrinkage. However, over time~     the tumor learns to grow despite continued hormonal treatment. Effective therapy for patients~     with hormone-resistant prostate cancer is lacking and patients often deteriorate quickly and~     die. Thus, there is a need for better treatment that cures prostate cancer at an early stage,~     and a better understanding of the biology of prostate cancer specifically with respect to~     factors that determine the effectiveness of RT, the spread of tumor and the development of~     hormone-resistant disease.~      Low levels of oxygen (hypoxia) are known to exist in many human tumors, and studies have~     shown that hypoxic tumors are less likely to be cured by RT. In addition, hypoxia may lead to~     lower cure rates following surgery, spread of cancer to other areas of the body, and changes~     in the genetic characteristics of the cancer cells that cause them to behave more~     aggressively.~      The importance of hypoxia in prostate cancer has not previously been evaluated. The aims of~     this study are to determine how often hypoxia occurs in early prostate cancer and whether~     hypoxia influences the success of RT, tumor spread beyond the prostate to bones and other~     organs and the development of hormone-resistant disease. Patients will have tumor oxygen~     levels measured using a special fine-needle electrode system prior to beginning treatment~     with either RT or the combination of hormones plus RT. The measurements will be made through~     the rectum using ultrasound to position and guide the electrode. A biopsy of the tumor will~     be obtained at the site of the measurements, and this will be used to determine how oxygen~     influences changes in the genetic character of prostate cancer cells. A total of 195 patients~     will be evaluated in this way over 3 years.~      This study will provide unique information about the behavior of prostate cancer, which may~     help explain why currently available treatments including surgery, RT and hormones fail to~     cure patients. Assuming that this study shows hypoxia to be important in prostate cancer,~     future work will focus on new anti-hypoxia treatments to be used in combination with surgery~     or RT with the aim of overcoming this obstacle and improving cure rates.~   "
258913|NCT00160966|"~     The aim of this study is to characterize and evaluate risk factors of polyomavirus~     nephropathy (PVN) including the impact of three immunosuppressive regimens.~   "
258914|NCT00160953|"~     When we acquired MR images of the prostate gland using a coil (receiver antenna) inside the~     rectum, we can see areas with tumour in the prostate gland, and well as details of the~     anatomy. The coil inside the rectum changes the shape of the prostate gland. In order to use~     this images to help target radiation therapy to the tumour better, we need to deform the~     images to the original shape of the prostate gland without the coil. In this study, we will~     develop a way to deform the images accurately.~   "
258943|NCT00160576|"~     This is a 41-week trial composed of two consecutive parts (Part A, 14 weeks and optional Part~     B, 27 weeks) to evaluate the efficacy of levetiracetam in controlling levodopa induced~     dyskinesias in adults with Idiopathic Parkinson's Disease, without negative impact on the~     benefit on the motor function of the antiparkinsonian treatment.~   "
258944|NCT00160563|"~     Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic~     Children).~      36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing~     the onset of asthma in young atopic children.~   "
259043|NCT00159276|"~     To investigate a possible mechanism of the GR defect in patients with severe COPD by studying~     the effect of dexamethasone (Dex) on GR-GRE binding, expression of inflammatory and~     anti-inflammatory factors such as IL-6, IL-8, MKP-1, GILZ, SLPI production in sputum cells~   "
258915|NCT00160940|"~     The purpose of this research is to study body materials like blood proteins as well as white~     blood cell and liver cellular RNA in individuals with liver diseases such as chronic viral~     hepatitis with or without hepatoma and autoimmune liver disease. Presently it is not~     understood how infection with chronic viral hepatitis or autoimmune liver disease damages the~     liver. This research study enroll patients with either chronic viral hepatitis with or~     without hepatoma or autoimmune liver disease.~      The purpose of this study is to find the genes that are expressed in both the circulating~     white blood cells and the liver of patients with varying degrees of liver damage of different~     causes. Genes are biological messengers some of which determine how the body responds to~     injury. We anticipate that results from Differential Gene Expression (DGE) analysis will~     allow us to make predictions about likelihood of disease progression and/or response to~     treatment.~      In addition we will test the blood for markers of injury. The blood collected will be~     prepared differently from the liver tissue. We will use technologies to express pure proteins~     and then we will investigate the functions of these proteins. Nearly all drugs act on~     proteins, not genes, so understanding proteins is the key to really effective new medicines.~     Similarly the first signs of ill health appear in changes to the body’s blood proteins,~     making them the most sensitive diagnostic indicators. The studies we plan are called~     proteomics.~      We will later correlate the patterns of gene expression in both circulating white blood cells~     and the liver tissue with clinical outcome and patterns of proteins measured in blood and we~     hope to gain an understanding of how the disease process occurs, which may in turn help us to~     make more precise diagnoses and develop new forms of treatment.~      These techniques that we use are still experimental and so we do not yet know if they will be~     helpful in monitoring changes which may help us to predict the potential severity of your~     liver disease or even if they can be used to indicate who will best respond to treatment.~   "
258916|NCT00160927|"~     Vascular and neurological mechanisms are both likely to be involved in foot ulcer. We~     recently reported on the hand an original transient pressure-induced vasodilation (PIV)~     during a 5 mmHg/min increase of pressure strain using laser Doppler flowmetry. This~     physiological response to non noxious external local pressure strain is a widely protective~     cutaneous mechanism. The impairment of PIV in diabetic subjects may be relevant to the high~     prevalence of foot ulcer that occurs in these individuals. The aim of the project is to~     analyse the different physiopathological processes involved in PIV impairment in diabetic~     subjects as compared to matched controls.~   "
258917|NCT00160914|"~     Childhood obesity has been described as a growing national epidemic. Between 1980 and 1994~     the prevalence of childhood obesity doubled with 10% to 15% of children and adolescents being~     obese. Childhood obesity has both immediate and long-term detrimental consequences for health~     and well-being. Obese children are at increased risk for coronary heart disease, type 2~     diabetes, and hypertension. Obese children are more likely to be at risk for psychological~     stress and disturbed body image. Moreover, obese children are more likely to become obese~     adults, especially if weight reduction has not occurred by the end of adolescence.~      The pediatrician is in an ideal position to assess and manage childhood obesity. Recently,~     guidelines have been established for the assessment and treatment of childhood obesity. These~     best practice guidelines include recommended diagnostic criteria, assessment of~     contributing factors such as diet and lifestyle, family history, and treatment choices.~     Although these guidelines have been introduced little is known about pediatricians' actual~     practice patterns and their beliefs concerning childhood obesity.~      Project Description I plan to conduct a national survey of pediatricians to assess common~     strategies for the identification and management of childhood obesity, along with~     pediatricians' attitudes and beliefs about childhood obesity. In consultation with a panel of~     practicing general pediatricians and survey research experts, I plan to develop a survey that~     measures pediatricians' beliefs about the causes and consequences of childhood obesity, its~     prevalence in their practice settings, their approaches to diagnosis and management, and~     resources available for treatment. The survey will be administered to a randomly selected~     national sample of approximately 600 practicing general pediatricians. The response rate is~     expected to be approximately 60% or 360 pediatricians. The survey results will help to assess~     the degree to which recommended practice guidelines are being implemented, identify~     pediatricians' beliefs and attitudes that might serve as barriers to optimal care, and~     suggest areas for continuing medical education. The proposed time frame for the study is two~     years.~   "
258918|NCT00160901|"~     The purpose of this study is to determine wether a complementary therapy consisting of a~     combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation~     concerning nutrition and physical activity can reduce side effects of a chemotherapy in~     breast cancer patients.~   "
258919|NCT00160888|"~     The objective of the study is to assess the impact of genetic variation (especially~     polymorphisms of the gene coding endothelial nitric oxide synthase (eNOS) and the bradykinin~     B2 receptor gene) on venous and arterial responsiveness to vasodilators in healthy~     individuals without cardiovascular risk factors.~   "
258920|NCT00160875|"~     Cancer of the esophagus is a very serious cancer. Studies have shown that using chemotherapy~     and radiation before surgery is the most promising treatment approach, with one quarter to~     one half of tumors shrinking by 50% or more in size after chemotherapy and radiation. In~     patients who have a very good response to this treatment, survival following esophagectomy~     has increased, although the amount of increase has varied quite a bit between the different~     studies. Older studies have used the drugs Cisplatin and 5-fluoruracil. Although this~     combination of drugs has been beneficial, we wish to use a newer combination of drugs which~     may be more effective for esophageal cancer. The chemotherapy drugs used in this study are~     Cisplatin and Irinotecan. We also want to find out what side effects these drugs cause when~     given with radiation, and how often these side effects occur.~   "
258921|NCT00160862|"~     The primary objective is to determine the effect of a single oral dose of 250 mg SLV 317 on~     substance P-induced venodilation in the hand vein of healthy male volunteers as compared to~     placebo.~   "
258922|NCT00160849|"~     1. Objectives Primary~             -  To investigate the possibility of maintaining virological suppression of HIV in~               infected patients, switching them to LPV/r as the only antiretroviral agent~             -  To assess the immunological response in patients who switched to LPV/r as single~               agent, based on the observation of changes in the serum levels of CD4+ cells.~           Secondary~             -  To investigate the rate of clinical and laboratorial adverse events in the two~               treatment groups.~             -  To investigate the rate of emergence of antiretroviral resistance mutations in the~               two treatment groups, in case of virological failure of the current regimen.~             -  To describe the adherence to the prescribed regimen in the two treatment groups~             -  To describe changes in body fat distribution (abdominal, arms and thigh~               circumference) and in the lipid profile, in patients from the two treatment groups~             -  To describe the rate of clinical failure of the antiretroviral therapy in the two~               treatment groups.~        2. Patient population:~           The 60 patients were selected by the investigators according to the study’s inclusion~          and exclusion criteria, and were divided into 2 groups with 30 patients each.~        3. Study design:~           The study is multicentric, open-label, randomized. Virological, immunological and~          clinical failures will be analyzed in both groups. In addition, data on clinical or~          laboratorial toxicity and compliance are being recorded.~        4. Regime:~             -  Group 1 maintenance of the currently used antiretroviral therapy~             -  Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12~               hs with food. Patients in group 2 who were being treated previously with~               non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were~               instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days~               of therapy (up to Week 2 visit).~        5. Duration:~      96 weeks of treatment~   "
258945|NCT00160550|"~     This study will assess the efficacy, safety, and tolerability of adjunctive treatment with~     LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in~     reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized~     epilepsy uncontrolled despite treatment with one or two concomitant AEDs.~   "
258946|NCT00160537|"~     Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as~     measured by the subject's satisfaction/dissatisfaction after one week of treatment~   "
258947|NCT00160524|"~     An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with~     Crohn's Disease who have completed a 26-week blinded study (CDP870-031 [NCT00152490] or~     CDP870-032 [NCT00152425]).~   "
260519|NCT00139659|"~     A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics~     with Asthma~   "
258923|NCT00160836|"~     Introduction In patients with a biliary obstruction, tissue is acquired immediately before~     drainage during endoscopic retrograde cholangio-pancreatography (ERCP). This is performed by~     passing a brush inside the bile duct stricture. However, brush cytology has a modest~     sensitivity (30-57%) for the diagnosis of cancer. A device, called the G.I.U.M. catheter,~     allows for the sampling of higher amounts of tissue during ERCP compared to brush cytology.~     The aim of this study is to compare the diagnostic yield of tissue sampling performed in~     patients with a suspected malignant biliary stricture using 2 techniques, namely a standard~     brush catheter and the G.I.U.M..~      Protocol design Eligible patients will have tissue sampling performed using both techniques~     during ERCP, the first technique used being randomly assigned and immediately followed by the~     other one as well as biliary decompression. All specimens obtained will be subjected to~     cytopathological examination. After inclusion of the total number of patients, smears will be~     anonymized and analyzed for diagnosis, cell cellularity and quality. The final clinical~     diagnosis in each case will be based on cytologic results plus histological examination of~     biopsy specimens.~   "
258924|NCT00160823|"~     The quality of colon cleansing has a major impact on efficiency and cost of colonoscopy. A~     hand-out was made to instruct and motivate patients to adequately clean the bowel before~     colonoscopy.~      The aim of the study is to compare adequacy of bowel cleansing in hospitalized patients~     receiving the hand-out or not on the day before colonoscopy.~   "
258925|NCT00160810|"~     The purpose of this study is to collect information about how people do after different~     treatments of a broken wrist to see if one treatment has better results.~   "
258926|NCT00160797|"~     The purpose of this study is to gather information about total knee replacement surgery using~     minimally invasive surgical procedures.~   "
258927|NCT00160784|"~     The purpose of this study is to compare two treatments used for treating frozen shoulder~     which are arthroscopy and forceful stretching of the shoulder and home stretching therapy to~     see if one relives pain and improves shoulder motion more quickly. The other purpose is to~     try and understand what causes frozen shoulder. For this purpose, tissue will be taken from~     the shoulder during surgery and studied for the presence and level of a protein called~     cytokine (Connective Tissue Growth Factor)~   "
258928|NCT00160771|"~     The purpose of the data bank is to collect data on joint motion.~   "
258929|NCT00160758|"~     This purpose of this study is to measure the strength of tissue allografts that have been in~     the body various lengths of time.~   "
258930|NCT00160745|"~     The endothelium plays an important role in the regulation of vascular tone and regulation of~     blood flow. Nitric oxide (NO) is the most important known endothelium-derived vasodilating~     factor. Prospective studies have shown that hypercholesterolemia impairs endothelial function~     in different vascular beds. Lowering total cholesterol and particularly LDL-cholesterol with~     statins leads to an improvement in endothelium-dependent vasodilation in the forearm~     vasculature. There is strong evidence to suggest that the benefit is not merely related to~     the decrease in cholesterol-levels. A recent study in the forearm vasculature demonstrated~     that short-term lipid-lowering therapy improves endothelial function and NO availability~     already after 3 days of lipid lowering therapy. Whether endothelial function in the renal~     vasculature of hypercholesterolemic patients is similarly influenced has not yet been~     addressed adequately. In the present study we investigate whether lipid lowering therapy with~     rosuvastatin alters renal endothelial function, as assessed by systemic infusion of the NO~     synthase inhibitor L-NMMA, after 3 and 42 days of therapy.~   "
258931|NCT00160732|"~     The purpose of this study is to determine the safety of transplanting human islet cells for~     controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In~     addition, initial observations will be made with regards to the effectiveness of reversing~     hypoglycemia with this treatment. The Edmonton Protocol of using specific anti-rejection~     drugs without steroids is also being evaluated.~   "
258932|NCT00160719|"~     The purpose of this study is to find out whether or not antibodies to the donor bone are~     present in the blood of patients who receive the donor bone.~   "
258933|NCT00160706|"~     A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn~     from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an~     exacerbation of Crohn's Disease.~   "
258934|NCT00160693|"~     The primary purpose of this study is to obtain long-term safety data with CZP in patients~     with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of~     Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on~     physical function. Treatment will continue up to approval of a marketing application for this~     product.~   "
258935|NCT00160680|"~     Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on~     demand, measured by evolution of individual symptom scores during 6 months.~   "
258936|NCT00160667|"~     Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic~     neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor~     down-titration.~   "
258937|NCT00160654|"~     Community based study assessing safety and efficacy of levetiracetam in partial onset~     seizures.~      The optimal dose in daily clinical practice will be used.~   "
258938|NCT00160641|"~     An open ended study in which patients who completed the preceding double-blind study~     NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid~     Arthritis.~   "
258939|NCT00160628|"~     A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam~     as adjunctive therapy in partial epilepsy.~      Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.~   "
258940|NCT00160615|"~     The safety and efficacy of L059 will be evaluated in patients who completed N165 Clinical~     Trial of L059. They will receive L059 at a daily dose from 1,000 mg to 3,000 mg in addition~     to their standard concomitant AEDs~   "
258941|NCT00160602|"~     A 24 week study in which patients are given study medication and assessed for signs and~     symptoms of rheumatoid arthritis. X-rays are performed to assess the progress of joint damage~     during the study.~   "
258942|NCT00160589|"~     Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in~     patients suffering from Allergic Rhinitis (AR)~   "
258950|NCT00160485|"~     The purpose of this study is to determine whether the oral administration of glyburide is as~     effective as insulin in the treatment of gestational diabetes.~        1. SYNOPSIS: Infants born to mothers with gestational diabetes(GDM) are at risk for a~          variety of adverse perinatal outcomes including macrosomia with subsequent birth trauma~          and cesarean delivery, neonatal hypoglycemia, polycythemia, jaundice, hypocalcemia,~          respiratory depression and newborn intensive care unit admission. These adverse outcomes~          are thought to be related to the degree of maternal hyperglycemia during pregnancy.~          Women with GDM are typically treated with insulin to lower blood glucose levels to as~          near-normal as possible. A single randomized trial has suggested that the oral~          sulfonylurea, glyburide is a clinically effective and safe alternative to insulin~          therapy.~        2. Many obstetric care providers have adopted the use of glyburide in the routine~          management of gestational diabetes. The American College of Obstetrics and Gynecology~          and the American Diabetic Association both state that further studies are needed in a~          larger patient population before the use of newer oral hypoglycemic agents can be~          supported for use in pregnancy.~        3. STATUS: Previous studies have demonstrated that there is no maternal-fetal transfer of~          glyburide and when compared to insulin is an effective alternative to insulin.~          Additionally, a published cost analysis concluded that glyburide is significantly less~          costly than insulin for the treatment of GDM. The benefits of an oral agent for the~          management of gestational diabetes include less discomfort for the patient in drug~          administration, lower requirement for patient education in the administration of~          injectable medications and less chance of error in dosing. Our study population is more~          ethnically diverse and our incidence of large for gestational age infants is lower than~          in the largely Hispanic population studied by Langer et al. Many obstetricians,~          including ourselves, apply different criteria than Langer for diagnosing gestational~          diabetes , and for deciding when to institute insulin therapy. It is our goal to confirm~          the prior single study concerning the safety and efficacy of glyburide in reducing the~          complications of GDM utilizing a more ethnically diverse population with more realistic~          goals in glycemic control. To this end we will add to the medical literature supporting~          this alternative therapy to insulin.~   "
258951|NCT00160472|"~     This study will evaluate the expression of arginine vasopressin (AVP) by peptide and mRNA~     quantitation and also measurement of its V1 receptor mRNA, in the arteries and veins of~     ovarian malignant (cancerous) or benign (non-cancerous) tissue. The investigators will~     examine whether AVP protein and AVP and V1 receptor mRNA expression vary with respect to~     tumor histology, intratumoral vascularization and systemic blood pressure.~   "
258952|NCT00160459|"~     This study was designed to determine the safety and effectiveness of 3 asoprisnil doses~     compared to placebo, taken for 12 weeks by women with uterine fibroids.~   "
258953|NCT00160446|"~     The objective of this study is to determine the safety and effectiveness of three doses of~     asoprisnil, compared to placebo, in the treatment of women with endometriosis.~   "
258954|NCT00160433|"~     The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses~     (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.~   "
258955|NCT00160420|"~     The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12~     months in women with endometriosis from study M01-398.~   "
258956|NCT00160407|"~     The purpose of this study is to determine if orlistat (Xenical) therapy in overweight~     patients with NASH leads to enhanced weight loss over time, with subsequent improvement in~     the underlying necroinflammatory and fibrotic changes that are typical of NASH.~   "
258957|NCT00160394|"~     Comparing the efficacy and safety of a gel formulation containing a combination of~     clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily~     with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to~     moderate severity.~   "
258958|NCT00160381|"~     The objective of this study is to determine the safety and effectiveness of asoprisnil in~     symptomatic women with abnormal uterine bleeding associated with uterine fibroids.~   "
258959|NCT00160368|"~     The purpose of this study is to determine the effect of potassium chloride and potassium~     bicarbonate on blood pressure and also to determine whether increasing potassium intake has~     beneficial effects on the surrogate markers of target organ damage in cardiovascular disease,~     as well as on bone health.~   "
258960|NCT00160355|"~     Wiskott - Aldrich syndrome (WAS) is a rare disorder curable only through allogeneic~     hematopoietic stem cell transplantation. A mismatched family member is an option when no~     human leukocyte antigen (HLA-immune system type) matched related or matched unrelated donor~     is available.~      This study will evaluate a novel therapeutic strategy for patients with WAS who undergo~     haploidentical transplantation using a parental donor. To reduce the risk of~     transplant-related toxicities, participants will receive a reduced intensity chemotherapy and~     antibody regimen (conditioning treatment). Participants will then receive an infusion of~     donor stem cells depleted of certain white blood cells called T- and B-lymphocytes. The stem~     cell depletion processing will be done through the use of the investigational CliniMACS~     device. A certain number of T-lymphocytes will be added back to the processed stem cell graft~     prior to infusion into the recipient.~      The primary objective of this study is to determine the safety of haploidentical~     transplantation in WAS patients using this specified conditioning regimen and engineered~     graft. Safety will be defined in terms of engraftment (meaning how well the graft grows and~     functions after infusion) and regimen-related toxicity within the first 100 days after~     transplant.~   "
258961|NCT00160342|"~     This is a research study to evaluate the effectiveness, safety and side effects of several~     dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and~     in combination compared to a placebo (a tablet with no active drug in it) as a possible~     treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and~     testosterone are two hormones which are typically deficient in menopausal women~   "
258962|NCT00160329|"~     The study is looking to compare the impact of lipid levels and HIV viral loads between three~     different drug regimens: Continuing current regimen (ritonavir boosted regimen), Switching to~     Atazanavir, or Switching to Atazanavir in combination to Ritonavir.~   "
258963|NCT00160316|"~     The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg~     estradiol and 2.5 mg dydrogesterone.~   "
258964|NCT00160303|"~     The purpose of the research is to study the effects of two different injection therapies for~     the treatment of lateral epicondylitis (tennis elbow). Specifically, we will look at which~     therapy provides better short and long-term relief of pain, which treatment allows better~     function and less disability, and which treatment gives back better strength in the affected~     hand. Each subject will receive only one of the two treatments. Although both of these~     treatments are usually very well tolerated, it is important to make this comparison because~     it is believed that one of these therapies may have better long term effectiveness, with a~     lower cost, and smaller number of potential side effects.~   "
258965|NCT00160290|"~     To demonstrate that lactulose acts as a stool softener, relieving the pain at defecation,~     improving the number of defecations and regulating the colonic transit time in patients~     suffering of hemorrhoids or anal fissure. To compare efficacy and quality of life in patients~     treated either with lactulose or plantago ovate.~   "
258968|NCT00160251|"~     The primary objective of this study is to determine the safe and effective dose range of~     boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic~     hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy~     with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin~     provides an additional benefit when combined with PEG-Intron plus boceprevir.~   "
258969|NCT00160238|"~     This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural~     and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in~     patients suffering from disabling Menière's disease.~   "
258970|NCT00160225|"~     This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top~     of losartan.~   "
258971|NCT00160212|"~     This study is to compare the efficacy and safety of increasing doses of SLV306 with~     amlodipine.~   "
258972|NCT00160199|"~     To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in~     women of reproductive age with secondary amenorrhea~   "
258973|NCT00160186|"~     The purpose of this study is to investigate BMI and the nutritional parameters of Creon~     (pancreatin) versus placebo after a total or subtotal gastrectomy.~   "
258974|NCT00160173|"~     This study is intended to establish the lowest effective dose of EstroGelÂ® for the treatment~     of vasomotor symptoms associated with menopause.~   "
258975|NCT00160160|"~     This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus~     ramipril/HCTZ.~   "
258976|NCT00160147|"~     This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and~     behavioral disturbances associated with dementia of the alzheimer's type.~   "
258977|NCT00160134|"~     The study is a randomized, placebo controlled, multi-center, single dose study to evaluate~     cardiac hemodynamics and safety of iv SLV320 in 110 subjects with congestive heart failure~     requiring diuretic treatment. Each subject will receive one dose of SLV320 or placebo or~     furosemide. The study consists of three visits (or study days when in-subjects are included).~     Ambulatory subjects will be in hospital for two nights and one day.~   "
258978|NCT00160121|"~     The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis~     level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and~     to determine the patient and physician's satisfaction.~   "
258979|NCT00160108|"~     Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat,~     low-carbohydrate and Mediterranean diet) for weight loss~   "
258980|NCT00160095|"~     The purpose of this study is to identify in a prospective manner microregional profiles of~     oxygenation and proliferation based on exogenous and endogenous markers that are predictive~     for outcome of radiotherapy in squamous cell carcinoma of the larynx and to investigate if~     these profiles can identify patients that are most likely to benefit from hypoxia modifying~     treatment strategies like ARCON (Accelerated radiotherapy combined with carbogen breathing~     and nicotinamide).~   "
258981|NCT00160082|"~     The primary objective was to assess the effect of Xepol compared to placebo on physical~     health and on muscle strength in subjects with post-polio syndrome.The secondary objective~     was to assess the effect of Xepol compared to placebo on functional balance, activity~     patterns, pain, fatigue, sleep, vitality, muscular strength, pulmonary capacity, walking~     ability, balance and safety.~   "
258982|NCT00160069|"~     Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in~     patients with stage IIIb or stage IV non-small-cell lung cancer.~   "
258983|NCT00160056|"~     Hypoglycaemia unawareness is a common complication in patients with type 1 diabetes and with~     insulin-treated type 2 diabetes of long duration. The loss of autonomic symptoms to~     hypoglycemia does not solely depend on loss of adrenaline responses.Differences in~     sensitivity to catecholamines may also be involved.~      Reconciling the data on β2-adrenergic receptor polymorphism to those on loss of β-adrenergic~     sensitivity in diabetic patients with hypoglycemia unawareness, we hypothesize that~     hypoglycemia unawareness is at least partly the result of desensitization of the~     β2-adrenergic receptor and that patients who are homozygous for arginine at codon 16 are~     particularly susceptible for this desensitization process, whereas patients who are~     homozygous for glycine at codon 16 are resistant for desensitization.~      Objectives~        1. To determine whether, and if so to what extent, antecedent hypoglycemia reduces~          β2-adrenergic sensitivity in healthy subjects with Arg16 homozygosity.~        2. To investigate whether or not healthy subjects with Gly16 homozygosity are resistant to~          desensitization~        3. To confirm that antecedent hypoglycemia reduces the heart rate response to isoproterenol~          and to assess to what extent this reduced response is mediated by impairments in~          baroreflex sensitivity.~   "
258984|NCT00160043|"~     The purpose of this study is to determine whether the study drug is effective and safe in the~     treatment of patients with non small cell lung cancer who have already received one platinum~     based chemotherapy.~   "
258985|NCT00160030|"~     The primary objectives of this study are to assess the feasibility (completion of full~     treatment) in both arms and to assess endoscopic complete response rate in both arms.~      The secondary objective of this study is to assess the toxicity profile of each arm using the~     National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).~   "
258986|NCT00160017|"~     The study tests whether implementing professional evidence-based guidelines and best~     practices for diabetes care -through participation of multidisciplinary teams in a~     Breakthrough collaborative- results in an improvement of diabetes care, its health outcomes~     and economic costs. Determinants of success are studied. Data on diabetes will also be used~     to better understand Breakthrough as an implementation or improvement method.~   "
259003|NCT00159796|"~     Bipolar disorder is characterized by mood swings that range from high (manic) to low~     (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed~     episodes). Asenapine is an investigational medication for the treatment of manic or mixed~     episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy~     of this medication. Participants will receive either asenapine, olanzapine (a medication that~     is already approved for the treatment of bipolar mania), or placebo (no active medication).~     Participants will be required to stay in the hospital for at least the first seven days of~     treatment. Participants who complete the 3 week study may be eligible to continue in~     extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.~   "
258987|NCT00160004|"~     Amyotrophic Lateral Sclerosis (ALS) is a progressive neurological disorder characterized by~     amongst others asymmetric muscle weakness, respiratory insufficiency and spasticity. The~     disease is usually fatal within 2-3 years and until now there is no cure. ALS patients are~     usually supported by a multidisciplinary team. One of the members of this team is the~     physical therapist. The aim of physical therapy might be to enhance or to preserve~     cardiovascular fitness and muscle strength. Some authors suggest, however, that a moderate to~     high intensive exercise programme might lead to overuse weakness (an undesired fast~     progression of muscle weakness). The primary objective of this study is therefore to~     investigate whether regular moderate to high intensity exercise program in ALS can maintain~     or optimize cardiorespiratory fitness and muscle strength. A secondary objective is to~     investigate whether such a programme leads to overuse weakness and if there is a positive~     influence on patient's disability, fatigue and quality of life.~   "
258988|NCT00159991|"~     There is a remarkable lack of randomized trials concerning the potential benefit of using~     arterial conduits for coronary bypass surgery. This is the purpose of the present trial.~     Exclusive use of arterial conduits might result in improved conduit viability, reduced risk~     of recurrent angina, myocardial infarction and other cardiac events, reduced need for~     antianginal medication, improved functional status and possibly improved long term survival.~     The patients will be followed for ten years after surgery.~   "
258989|NCT00159978|"~     Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to~     radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor~     characteristics is performed in biopsies using immunohistochemical staining and subsequent~     analysis. A promising non-invasive method of characterizing a tumor is the use of~     positron-emission tomography (PET). Specific tracers can be used to detect hypoxia and~     proliferative activity. 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a~     tracer for proliferation.~      Patients suffering from head and neck cancer and who will undergo surgery will be included in~     this study.~      One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of~     the tracers. Shortly before the surgery they will be given immunohistochemically detectable~     marker substances enabling the characterization of the tumor samples gathered from the~     resection specimen. These markers are pimonidazole for detection of hypoxia and~     iododeoxyuridine for detection of tumor cell proliferation.~      The data collected by PET-scan will be analysed and compared to the results acquired by~     immunohistochemistry.~   "
258990|NCT00159965|"~     The investigators propose that treatment of the comorbid disorders (depression, anxiety, and~     impulsivity) with sertraline in patients with lone psychogenic nonepileptic seizures (NES),~     will result in a decreased number of NES. The purpose of this study is to provide pilot~     testing and data to inform the future randomized controlled trial based on the hypothesis.~   "
258991|NCT00159952|"~     The purpose of this study is to determine the effect of the intensive insulin therapy on~     coagulation and fibrinolysis in patients affected by severe sepsis and septic shock. As a~     secondary endpoints the investigators will determine the effect of intensive insulin therapy~     on organ dysfunction and mortality of these patients.~   "
258992|NCT00159939|"~     The purpose of this study is to determine whether prone positioning is effective in improving~     survival in patients affected by acute respiratory distress syndrome (ARDS).~   "
258993|NCT00159926|"~     Cardiac surgery using heart and lung machine produces an inflammatory reaction in the body.~     This leads in few percent of cases to heart, lung, and kidney disturbances that potentially~     causes death. White blood cells in contact with the heart and lung machine and external~     surfaces release mediators partly responsible for this. Blood collected by the suction and~     the blood remaining in the heart and lung machine after its use, can be cleaned by a cell~     saver before reinfusion, and this might reduce the inflammatory response.~   "
258994|NCT00159913|"~     This is a clinical research study designed to evaluate sildenafil for the treatment of~     Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is~     to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with~     oral sildenafil given in three different doses, compared to placebo (inactive treatment).~     Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may~     be eligible to take part in an extension study, in which all patients will receive active~     treatment of sildenafil.~   "
258995|NCT00159900|"~     The study objective is to evaluate the effect that sildenafil citrate has on the hardness of~     erections in males with erectile dysfunction, based on subject responses to question 5 on the~     Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).~   "
258996|NCT00159887|"~     Open label extension study to the pivotal efficacy study to assess the safety of sildenafil~     citrate in patients with pulmonary arterial hypertension~   "
258997|NCT00159874|"~     Active treatment, dose-blinded extension study evaluating the safety and long term efficacy~     of sildenafil citrate in children with PAH.~   "
258998|NCT00159861|"~     Determination of the effects of sildenafil citrate and epoprostenol when used in combination~     in patients with pulmonary arterial hypertension~   "
258999|NCT00159848|"~     This study will demonstrate if a treatment optimization program has an impact on the~     satisfaction with Viagra treatment in men with erectile dysfunction~   "
259000|NCT00159835|"~     To investigate whether a long-term strategy to lower LDL cholesterol with atorvastatin as~     much as possible will improve prognosis in CHD patients compared with a strategy reflecting~     current best clinical practice with simvastatin.~   "
259001|NCT00159822|"~     To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven~     chronic bronchopulmonary aspergillosis, in minimally immunocompromised or~     non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary~   "
259002|NCT00159809|"~     This study will measure the impact of treatment with Viagra on the depressive symptoms and~     quality of life in men with erectile dysfunction who have untreated depressive symptoms~     meeting the DSM-IV criteria for dysthymia or depression not otherwise specified (NOS),~     including minor depressive symptoms but excluding any form of psychotic disorder.~   "
259090|NCT00158665|"~     The purpose of the study was to find out if children 5 through 8 years of age who are getting~     influenza vaccine for the first time should get one or two doses.~   "
259004|NCT00159783|"~     Bipolar disorder is characterized by mood swings that range from from high (manic) to low~     (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed~     episodes). Asenapine is an investigational medication for the treatment of manic or mixed~     episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension~     study) could continue with the same treatment that they had been receiving: asenapine or~     olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40~     -week continuation study.~   "
259005|NCT00159770|"~     Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine,~     risperidone or quetiapine in patients with schizophrenia, schizoaffective and~     schizophreniform disorders under naturalistic conditions of clinical practice~   "
259006|NCT00159757|"~     There has been evidence that ziprasidone is efficacious in decreasing the magnitude of both~     positive and negative symptoms of schizophrenia, and also effective in the treatment of~     depressive symptoms. It shows good tolerance with low incidence of extrapyramidal side~     effects and does not significantly influence body weight. As it has been shown that~     ziprasidone is efficacious and safe in patients who have been pretreated with other~     antipsychotic that has to be withdrawn either due to the side effects or not satisfied~     efficacy. The purpose of the study was to provide further evidence for the efficacy and~     safety of patients with schizophrenia and allow for psychiatrists in Hungary to gain~     experience with the drug before wide commercial availability.~   "
259007|NCT00159744|"~     Bipolar disorder is characterized by mood swings that range from high (manic) to low~     (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed~     episodes). Asenapine is an investigational medication for the treatment of manic or mixed~     episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy~     of this medication. Patients will receive either asenapine, olanzapine (a medication that is~     already approved for the treatment of bipolar mania), or placebo (no active medication).~     Patients will be required to stay in the hospital for at least the first seven days of~     treatment. Patients that complete the 3 week study may be eligible to continue in extension~     studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.~   "
259008|NCT00159731|"~     The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional~     months to patients who have taken part in the placebo controlled study A0081060; and 2) find~     out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)~   "
259009|NCT00159718|"~     To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the~     combination in patients with symptomatic myocardial ischemia.~      Amlodipine's use in angina has been well documented in clinical trials such as the Circadian~     Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical~     practice has not been tested. Furthermore, the potentially synergistic benefit of~     atorvastatin and amlodipine on inflammation ischemic activity has not been studied.~   "
259010|NCT00159705|"~     Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with~     neuropathic pain associated with lumbo-sacral radiculopathy.~   "
259011|NCT00159692|"~     To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure~     goal of <130/80 with amlodipine versus placebo in subjects initially treated with quinapril~     or losartan.~   "
259012|NCT00159679|"~     The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with~     painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600~     mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the~     study.~   "
259013|NCT00159666|"~     The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in~     patients with post-herpetic neuralgia~   "
259014|NCT00159653|"~     To demonstrate statistical superiority of the combination of latanoprost and timolol to the~     individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8~     AM, 10 AM, 4 PM at weeks 2, 6 and 12.~   "
259015|NCT00159640|"~     The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of~     chronic pain following a shingles infection.~   "
259016|NCT00159627|"~     The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to~     determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with~     volume overload due to CHF who are refractory to high dose diuretic therapy.~   "
259017|NCT00159614|"~     The purpose of this study is to characterize the safety and tolerability of KW-3902IV and~     measure its effect on renal function.~   "
259018|NCT00159601|"~     The purpose of this study is to investigate different aspects of Quality of Life and mental~     health in patients under treatment in a child and adolescent psychiatric outpatient clinic~     and in the normal population.~   "
259019|NCT00159588|"~     It is a common belief that patients with MOH rarely respond of preventative medications~     whilst overusing acute medications. However, no randomized trial has been done previously to~     prove such statement. Based on some clinical experiences, our hypothesis are patients with~     probably MOH may benefit from use of preventive medications better than treatment with abrupt~     withdrawal or no specific treatment.~   "
259020|NCT00159575|"~     Aim of study: To investigate whether four months of metformin treatment before IVF~     (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical~     pregnancy rate in normal-weight (body mass index [BMI] below 28 kg/m3) in PCOS (polycystic~     ovarian syndrome) women.~   "
259021|NCT00159562|"~     The purpose for this study is to determine whether psycho-education in groups is more~     effective than individual psycho-education for patients with bipolar disorder.~   "
259022|NCT00159549|"~     A parallell group study comparing the effect of an education program with an education and~     training program for patients with COPD. 30 participants in each group. Participants~     self-select which group they wanted to be in. Main outcome is SGRQ (a HQoL for patients with~     COPD).~   "
259023|NCT00159536|"~     To investigate the effect of metformin on pregnancy complications and pregnancy outcome in~     the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.~   "
259024|NCT00159523|"~     A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of~     pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic~     sensitisation and allergic disease at two years of age, compared to placebo.~   "
259025|NCT00159510|"~     Nitric oxide (NO) plays a pivotal role in maintenance of normal vascular tone. However, in~     sepsis the excessive production of NO results in myocardial depression, vasoplegia, and~     cytotoxic effects, thus promoting shock and multiple organ dysfunction. A recently completed~     study from our group showed advantageous cardiovascular effects of continuously infused~     methylene blue (MB), an inhibitor of NO pathway, in human septic shock. In another~     investigation, we have found that the combination of inhaled NO and continuously infused MB~     attenuates endotoxin-induced acute lung injury (ALI) in sheep. Our intention is, in a new~     study, to test the hypothesis that the combination of MB and NO (MB+NO) improves both~     cardiovascular and pulmonary functions as well as clinical outcome in patients with septic~     shock and ALI. Forty mechanically ventilated patients diagnosed with hyperdynamic septic~     shock and ALI, will be randomized to groups receiving~        1. Conventional treatment (control group)(n =10);~        2. MB infusion in addition to conventional treatment (n=10);~        3. Inhaled NO in addition to conventional treatment (n=10);~        4. MB infusion combined with inhaled NO (MB+NO) in addition to conventional treatment~          (n=10).~   "
259026|NCT00159497|"~     This study was designed to investigate the influence of HA-coating on bone remodeling around~     the cup in cementless THA.~      100 patients gave informed consent to participate in a controlled randomized study between~     porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation.~     The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a~     modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral~     Density (BMD) determined by DEXA scanning.~      Measurements revealed no difference between the two groups after 3 years, neither in clinical~     outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above~     normal regained more bone mineral than patients with normal weight. This finding supports the~     assumption that load is beneficial to bone remodeling. Advantages of better sealing of the~     bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be~     anticipated for the 7 or 12 year follow-up examinations~   "
259027|NCT00159484|"~     This study is for people with advanced colorectal cancer. This study uses the drugs Celebrex~     and EPO906. EPO906 is an experimental drug that has not been approved by the FDA. EPO906 is a~     drug that has been shown in the laboratory to cause cancer cells to die and prevents them~     from growing and reproducing. Celebrex is a drug that is approved by the FDA for the~     treatment of arthritis and prevention of colon polyps. Colon polyps are small growths in the~     colon. If not surgically removed, some colon polyps can become cancerous. Some studies have~     shown that Celebrex may reduce the side effects of chemotherapy. Other studies have shown~     that it may increase the effectiveness of some chemotherapy. Celebrex is not approved by the~     FDA for reducing the side effects of chemotherapy or improving the effectiveness of~     chemotherapy. The combination of EPO906 and Celebrex in this study is experimental.~      The main goal of this study is to see if adding the drug Celebrex to the drug EPO906 will~     decrease the amount of diarrhea seen in patients that receive EPO906.~      The goal of the first phase of this study is to find the highest dose of EPO906 that can be~     given safely with Celebrex. The dose of Celebrex will remain the same for the whole study.~     Higher doses of EPO906 will be given to each group of patients. The increase of EPO906 will~     stop once more than one patient has serious side effects. The highest dose of EPO906 that can~     be given with Celebrex (without serious side effects) will be called the pilot dose.~      The goal of the second phase of this study is to find out how tumors respond to these doses~     of the drugs. Another purpose of this study is to see how the body processes the EPO906 and~     Celebrex. This study will also look at the side effects of these drugs. In this study, we~     will measure how long subjects live, how often tumors shrink after receiving the study drugs,~     and how long it takes for tumors to increase in size after receiving the study drugs. This~     study will also measure the levels of genes, which are the cell's blueprint, in participant's~     tumors. Several genes can affect how people's bodies react to the cancer drugs. Genes will~     also be measured in participant's blood. We want to see if these predict response to the~     study drugs.~   "
259028|NCT00159471|"~     This is a study for patients with advanced pancreatic cancer, using the drugs gemcitabine,~     docetaxel and capecitabine. Gemcitabine is a drug that has been approved by the FDA.~     Gemcitabine is been approved for treatment of cancer of the pancreas. It is also approved for~     treatment of lung cancer in combination with another drug called cisplatin. Docetaxel is a~     drug approved by the FDA. Docetaxel is approved for treatment of breast and lung cancer.~     Capecitabine is a drug approved by the FDA for treatment of cancer of the colon and rectum.~     This study will measure the levels of certain substances in participant's tumors. These~     substances (called genes, which are the cell's blueprint for these substances) affect how~     people's bodies react to the cancer drugs. Genes will also be measured in participant's~     blood. The purpose of this study is to see if these substances can predict survival and~     response in patients receiving the study drugs. In this study we wish to find out how long it~     takes for patients' cancers to worsen, and how long they survive after receiving the study~     drugs. The side effects of the combination of gemcitabine, docetaxel and capecitabine will~     also be evaluated.~   "
259029|NCT00159458|"~     The purpose of this study is to find out if the combination of gemcitabine and oxaliplatin~     chemotherapy will be effective in reducing or eliminating the tumor(s) in patients with~     recurrent or metastatic breast cancer.~      Gemcitabine is a chemotherapy drug approved by the U.S. Food and Drug Administration (FDA)~     for the treatment of pancreatic and lung cancer; oxaliplatin is a chemotherapy drug that is~     approved by the FDA for the treatment of colon cancer. Neither gemcitabine nor oxaliplatin~     are approved for the treatment of breast cancer. However, both drugs have been shown to~     decrease the size of breast cancer tumors.~   "
259030|NCT00159445|"~     This study is for patients with colorectal cancer that has spread and has increased in size~     after standard treatments. This study is being done to find out how long it takes their~     tumors to grow after treatment with the chemotherapy drugs capecitabine and gemcitabine.~     Capecitabine is a chemotherapy drug that has been approved by the FDA for the treatment of~     colorectal cancer. We are adding another drug (called gemcitabine), which is approved by the~     FDA for the treatment of cancer of the pancreas to see if the ability of capecitabine to~     shrink tumors can be improved by adding gemcitabine. The side effects of the combination will~     also be evaluated. Another purpose of this study is to measure the levels of certain~     substances that affect how the body reacts to the chemotherapy agents in cancer cells (in the~     tumor). In addition, the genes (which are the cell's blueprint for these substances) will~     also be evaluated in the blood.~   "
259041|NCT00159302|"~     This pilot study will measure the baseline levels and the intra- and inter-subject~     variability of exhaled (alveolar and bronchial) and nasal NO in smoking subjects with mild~     and moderate COPD on or off steroid treatment, smoking healthy volunteers and non-smoking~     mild asthmatics off steroids, using multiple exhalation flow rates.~      In addition, exploratory markers of iNOS activity (eg. 3-nitrotyrosine, nitrite, nitrate and~     3-nitro-4-hydoxyphenylacetic acid) in blood, sputum, urine and exhaled breath condensate will~     be evaluated. We will also evaluate exhaled and nasal NO in a population of mild asthmatics~     in order to obtain baseline and variability data for future clinical studies involving~     asthmatic subjects.~   "
259164|NCT00157677|"~     The purpose of this study is to compare two diagnostic interventions to improve the way~     D-dimer blood testing (MDA D-dimer) is used to diagnose first time symptomatic deep vein~     thrombosis.~   "
259031|NCT00159432|"~     This study is for people with colorectal cancer, who have tumors that cannot be completely~     removed by surgery. This study is being done to find out how long it takes tumors to grow~     after patients receive the drugs capecitabine, oxaliplatin and bevacizumab. Capecitabine~     (also called Xeloda) is a drug that has been approved by the FDA for treatment of advanced~     colorectal cancer. Capecitabine prevents some colorectal cancer cancer cells from~     reproducing, and causes some of them to die. Oxaliplatin (also called Eloxatin) has also been~     approved by the FDA for treatment of advanced colorectal cancer. Oxaliplatin prevents some~     colorectal cancer cells from reproducing. Bevacizumab is an investigational drug. Bevacizumab~     is an antibody (a protein that acts against a specific substance) directed against vascular~     endothelial growth factor (VEGF). VEGF promotes the growth of blood vessels that bring~     nutrients to cells. Bevacizumab inhibits the growth of colon cancer cells, by blocking the~     effects of VEGF. The combination of the drugs used in this study is experimental. The purpose~     of this study is to see how long it takes patients' tumors to grow when they are taking this~     combination of drugs.~   "
259032|NCT00159419|"~     The study is designed to evaluate the efficacy and safety of Bisphosphonate Therapy for~     Osteogenesis Imperfecta (OI). We, the researchers at Indiana University School of Medicine,~     are characterizing the changes effected by oral bisphosphonate therapy and comparing them to~     a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in~     children with other disorders that result in low bone mass and fractures.~   "
259033|NCT00159406|"~     STATEMENT OF PURPOSE:~      Transurethral resection of the prostate (TURP) is the standard surgical intervention for~     obstructive benign prostatic hyperplasia (BPH) in all but the largest of glands, which are~     typically treated with open simple prostatectomy. Recently, new generation lasers (holmium~     and potassium titanyl phosphate [KTP]) have been utilized for BPH treatment. Long-term~     follow-up of laser prostatectomy outcomes must be documented to fully characterize the degree~     of voiding improvement achievable by these new techniques, the durability of these outcomes,~     and the safety profiles of these procedures.~   "
259034|NCT00159393|"~     Kidney stones vary in size from a tiny grain of sand to as large as filling the inside of the~     kidney. Treatment decisions depend on the size, location, and composition of the stone. Some~     kidney stones can be treated with lithotripsy (breaking up stones inside the body with shock~     waves created outside the body) or ureteroscopy (placing a small telescope up the urine~     channel to remove the stone). When stones are large in size or in the lower part of the~     kidney, a percutaneous (making a passage from the back into the kidney) procedure has been~     found to be the best method to remove the stones safely and efficiently. A passage is made~     into the back to allow a small telescope to see the stone and break it into fragments for~     removal. A small catheter is placed at the end of the procedure to allow the kidney to drain.~      The purpose of this study is to record information about your surgery into a database so we~     can look at how patients who have had this procedure have done over time. We hope that~     reporting the outcomes of this surgery will be helpful to urologists and patients in the~     future. There may be certain factors that can be identified through this study as having~     better outcomes that may help make future surgeries safer.~   "
259035|NCT00159380|"~     The primary aim of this study is to investigate the effects of oral and inhaled~     administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled~     NO and NO metabolites in exhaled breath condensate, saliva and nasal lavage fluid in normal~     and asthmatic subjects.~   "
259036|NCT00159367|"~     We intend to use repetitive magnetic stimulation to the quadriceps muscle to try to improve~     strength and improve the metabolic function of the muscle.~   "
259037|NCT00159354|"~     Neutrophil involvement in the development of COPD by smokers is well recognised. However not~     all smokers develop overt lung disease. We have previously shown that uptake of FDG is~     related to neutrophil activity and can be measured by PET and that uptake is greater in COPD~     patients than normal subjects. We have also shown that FDG−PET shows inflammatory changes in~     asymptomatic smokers after cigarette smoking. We plan to investigate the attenuation of this~     inflammation by steroid tablets and whether FDG PET can demonstrate this. We also wish to~     establish if similar changes are demonstrated after smoking by COPD patients.~   "
259038|NCT00159341|"~     This is a clinical research study to assess whether after exhaling a single cigarette smoke~     through the nose there are changes in the inflammatory cells and proteins of nasal~     secretions.~      A single blood sample from each subject will be stimulated with cigarette smoke in the~     laboratory to see the effects on inflammatory blood cells.~      Comparison of findings between smokers with COPD and Healthy smokers will be carried out.~      We hypothesize that some subjects have amplified inflammatory response to a single cigarette,~     and these will be those subjects who develop chronic obstructive pulmonary disease (COPD)~     after decades of smoking. We hope to develop an acute challenge model that relates to the~     causation of COPD. When studying the effects of new drugs, these may be detected in small~     numbers of patients in a challenge situation, when we would need to study many more~     unchallenged patients to demonstrate drug effects. In clinical research on asthma and~     allergy, the nasal allergen challenge has been a very successful model, and we hope to~     validate a comparable model for COPD.~   "
259039|NCT00159328|"~     The purpose of this study is to determine whether ablation of uterine fibroids with MR guided~     focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues~     will allow the effective use of this therapy in women with larger fibroids.~   "
259040|NCT00159315|"~     In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12~     healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve~     asthma; and 30 patients with mild-moderate COPD.~      Each subject will have 1 screening visit (if necessary) and 2 study visits. At visits 2 and 3~     the effects of adenosine 5`-triphosphate (ATP) or adenosine 5`-monophosphate (AMP) challenge,~     given in a random order, will be tested.~   "
259042|NCT00159289|"~     The primary aim of this study is to investigate the effects of inhaled lipopolysaccharide~     endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and~     other inflammatory markers and mediators in exhaled breath condensate, induced sputum, nasal~     lavage and mouthwash fluid in healthy non-smokers and current smokers, including patients~     with chronic obstructive pulmonary disease (COPD).~   "
259656|NCT00151099|"~     The purpose of the study is to determine whether the oral administration of a high caloric~     drink with protein decreases the postoperative nausea and vomiting in patients with~     dysgnathia.~   "
259044|NCT00159263|"~     To investigate a possible interaction between formoterol and budesonide on GR-translocation~     and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the~     effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect~     of the study drugs on exhaled NO (bronchial and alveolar fraction.~   "
259045|NCT00159250|"~     Duchenne muscular dystrophy (DMD), a fatal muscle degenerative disorder, arises from~     mutations in the dystrophin gene. Antisense therapy with the use of antisense~     oligonucleotides (AON) has the potential to restore effectively the production of dystrophin,~     the defective protein, in >70% of DMD. This could result in increased life expectancy through~     improved muscle survival and function. Recent scientific research has demonstrated the~     potential of this technique to skip mutated dystrophin exons, restore the reading frame and~     generate functional dystrophin protein. Having demonstrated proof-of-principle in human cell~     culture and animal model studies, we now intend to determine efficacy and safety of this~     approach to induce dystrophin exon skipping in children with DMD.~      The specific aim of this phase I/II study is to assess efficacy (dystrophin production) and~     safety of intramuscular administered morpholino oligomer directed against exon 51 (AVI-4658~     PMO). We are performing parallel preclinical studies to develop methods of systemic delivery~     that will be necessary for future phase II/III clinical studies.~   "
259046|NCT00159237|"~     T.to investigate a possible mechanism of the glucocorticosteroid receptors (GR) defect in~     patients with severe COPD by studying the effect of dexamethasone (Dex) on GR- binding,~     interleukin production (IL-6/IL-8) and MKP-1 expression in peripheral blood mononuclear cells~     blood (PBMC)~   "
259047|NCT00159224|"~     This study will assess the safety, tolerability and antiviral activity of a simplified~     PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients~     infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen.~      The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide~     spectrum of patients in a number of different clinical trials.6-9 The durable viral~     suppression seen after 4 years of therapy10 proves that it can provide effective, long-term~     treatment for people with HIV-1.~      Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in~     combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the~     treatment of HIV-1-infection.~   "
259048|NCT00159211|"~     In type 2 diabetic patients with poor glycemic control despite maximum classic oral~     treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and~     subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a~     decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is~     correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral~     abdominal fat in type 2 diabetic patients is of great importance.~      Main objective:~      To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time~     insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control~     despite a maximal oral treatment with metformin and sulfonylureas.~      The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue~     should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or~     NPH  bed-time  insulin (0.2u/kg/~   "
259049|NCT00159198|"~     Amyotrophic lateral sclerosis (ALS) with frontotemporal dementia (FTD) is a rare clinical~     entity, in which both disorders are variably associated in the same patient or within the~     family. This adult-onset disorder, which is rapidly fatal, occurs in some families with~     autosomal dominant (AD) transmission and age-dependant penetrance. Two studies have provided~     evidence for linkage of this condition to chromosomes 15 (in a single family) and 9 (in five~     families). However, none of these loci have been yet confirmed. Through a national network of~     10 centres with specialists for FTD and/or ALS, we have identified 35 probands with ALS-FTD,~     including 13 with a family history consistent with AD inheritance.~      Mutations in the SOD1 and tau genes, respectively responsible for autosomal dominant forms of~     ALS and FTD, will be excluded by direct sequencing. We will then extend the pedigree of the~     13 autosomal dominant families to all consenting first, second and eventually third degree~     relatives, using well defined criteria for FTD and ALS. The same strategy will be applied to~     newly identified families during the course of the project (at least, seven families with AD~     inheritance expected). Linkage studies will be performed in the 20 families using markers~     from the two candidate regions on chromosomes 9 and 15. Then, refinement of the candidate~     region will be obtained by analyzing the linked families with a high density of~     microsatellite markers. This should lead to the refinement of the candidate regions, allowing~     to search for mutations in candidate genes. Genes located within the critical regions will be~     prioritized for their analysis by sequencing, according to their expression in the nervous~     system and to their function.~      Once the responsible gene(s) will be identified, it will then possible to define its spectrum~     of mutations and to establish genotype/phenotype correlations. Alternatively, if none of the~     candidate regions is confirmed, a genome wide search will be performed, allowing to identify~     one or more loci for ALS-FTD. The same strategy would then be applied to identify the~     corresponding gene(s). This project should contribute for identifying the molecular basis of~     this devastating disorder with practical consequences for genetic counselling in ALS-FTD~     families, and with the perspective of elucidating the pathophysiology of this disorder.~   "
259050|NCT00159185|"~     The purpose of this study is to:~        -  Create a database including a description of the patient population that undergoes total~          hip replacement with special emphasis on orthopedic and cardiovascular complications and~          the quality of life 1 year postoperatively.~        -  Characterise the patient at risk for the above mentioned events~        -  Create methods for predicting patients at risk for short-term (90 days) and long term (1~          year) complications in relation to hip replacement surgery.~   "
259051|NCT00159172|"~     The purpose of this study is to determine whether motor cortex stimulation, a mildly invasive~     surgical procedure, is safe and effective in advanced stage Parkinsonian patients who display~     side effects with dopaminergic treatment.~   "
259052|NCT00159159|"~     Primary Objective:~        -  Evaluation of the benefit on renal function of one year of a low dose of ciclosporine~          versus the usual dose~      Secondary Objective:~        -  To evaluate the immunosuppressive efficacy and tolerance of the treatment~      Study Duration:~      Twelve months for each patient~      Study Treatment: Ciclosporine~      Group A: low dose >= 130 µg/l < T0 ciclosporinemia < 200 µg/l; Group B: standard dose >= 200~     µg/l < T0 ciclosporinemia < 300 µg/l.~      Study Visits:~      One visit every 15 days, for the first three months; then 1 visit every month, for 6 months;~     and 1 visit at 9 and 12 months.~      Associated Treatments:~        -  Mycophenolate (Cellcept®), 3g a day~        -  Corticoids, as used for transplanted patients~      Randomization: Randomization will occur when it is decided that ciclosporine will be~     introduced.~   "
259053|NCT00159146|"~     This study investigates the hypothesis that pindolol can accelerate the response to~     antidepressants in patients with major depression treated with venlafaxine.~   "
259463|NCT00153608|"~     In this trial HLA-A2+ patients with WT1 expressing carcinomas are vaccinated with a peptide~     from the leukemia associated antigen WT1 together with immunological adjuvants KLH as~     T-helper protein and GM-CSF~   "
259054|NCT00159133|"~     Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied~     in patients with first episode schizophrenia after one year neuroleptic maintenance~     treatment. Two groups of patients were followed over a period of 1 year: one further on under~     maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.~   "
259055|NCT00159120|"~     After one year neuroleptic maintenance treatment in patients with first episode~     schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized~     design) over a period of 1 year. Under both conditions prodrome based early intervention take~     place.~   "
259056|NCT00159107|"~     The main aim of this project consists in the investigation of the interaction of behavior~     therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized,~     prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A~     total of 371 patients has been randomly assigned immediately after detoxification to one of~     three different outpatient treat-ment conditions.~   "
259057|NCT00159094|"~     This is a phase II trial of Doxil on day 1 and vinorelbine on days 1 and 2 in women with~     metastatic breast cancer. Administered every 28 days. A study to assess the safety and~     efficacy of Doxil and vinorelbine in metastatic breast cancer.~   "
259058|NCT00159081|"~     Prospective, randomized, double-blind, multi-center study on 1 year course and treatment~     outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in~     first-episode schizophrenia.~   "
259059|NCT00159068|"~     Patients with HIV an have a variable course of their infection. We are trying to identify~     factors which worsen or ameliorate the course of the disease. Such factors may be related to~     metabolism (breakdown) of drugs or to iron handling by the body.~   "
259060|NCT00159055|"~     Treatment strategy of patients:~      Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative~     transplantation tolerance.~      Whenever indicated, additional post NST DLI given in graded increment, to optimize control of~     GVHD.~      Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a~     CMV-specific peptide followed by administration of immunized donor lymphocytes, or by~     injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient~     following DLI.~      Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or~     CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host~     by peptide immunization.~      Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo~     following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with~     relevant peptides.~   "
259061|NCT00159042|"~     Patients with genetic diseases can have widely differing severities. We are looking for~     genetic factors which influence the severity of beta thalassemia.~   "
259062|NCT00159029|"~     Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found~     in regions where malaria is endemic. We have found that alpha thalassemia is common in~     Ashkenazim, whose countries of origin are in temperate climates.~      We are analyzing the alpha globin genes of individuals of many ethnic groups and will compare~     to try to define the origin of thalassemia in these individuals of European extraction.~   "
259063|NCT00159016|"~     This is a phase II, multi-center (Israeli), open label, non-randomized trial for every~     patient with the specified tumors expressing c-kit or PDGFR. Expression of these kinases will~     be investigated in tumor samples obtained at the time of diagnosis or from the time of~     recurrent disease. Every patient with positive expression of either of the kinases will be~     evaluated for quantitative and qualitative evidence of disease prior to entry into the study,~     and if possible, no other treatment will be given concomitantly, to allow evaluation of the~     net effect of Glivec on tumor growth kinetics, searching for measurable evidence of response.~      Glivec is supplied to the study investigators by Novartis Pharmaceutical. Patients will~     receive Glivec 400mg-800mg p.o./day for an exposure period of up to 12 months provided that~     in the opinion of the investigator the patient is benefiting from treatment with Glivec, and~     in the absence of any safety concern. For patients with brain tumors who are not receiving~     concomitant enzyme inducing anti-convulsant drugs, the recommended dose of Glivec is~     800mg/day.~   "
259064|NCT00159003|"~     There are naturally occuring variations in the genetic makeup of all of us. Some of these~     variations may contribute to a change in susceptibility toward different diseases or change~     the prognosis.~      We are studying these genetic variations in patients with leukemia. The genes we are studying~     are those which influence detoxification of drugs and toxins.~   "
259065|NCT00158990|"~     The purpose of this project is to determine whether concurrent treatment of patients with~     major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead~     to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.~   "
259066|NCT00158977|"~     The RENEWAL 3 AVT device is designed to treat patients suffering from HF, with a history of~     or at risk of developing atrial and ventricular arrhythmias~   "
259067|NCT00158964|"~     The primary objective of this clinical investigation is to evaluate the safety and~     effectiveness of the EASYTRAK 4 STEERABLE LV lead.~   "
259068|NCT00158951|"~     The purpose of this clinical investigation is to demonstrate the safety and effectiveness of~     the CONTAK® RENEWAL™ 2/4/4HE cardiac resynchronization therapy defibrillator (CRT-D) family~     and EASYTRAK® 2 lead in delivering LV-CRT or BiV-CRT with an LV Offset for patients with~     heart failure and an indication for an ICD.~   "
259069|NCT00158938|"~     The purpose of this clinical investigation was to assess the safety and effectiveness of the~     EASYTRAK 3 lead~   "
259070|NCT00158925|"~     The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.~   "
259071|NCT00158912|"~     The purpose of VAST is to determine whether the Rate Smoothing feature in Guidant’s~     PRIZM/VITALITY-family ICDs has an effect on the incidence of ventricular tachyarrhythmias.~   "
259072|NCT00158899|"~     The purpose of this clinical research study is to compare up to 3 doses of an investigational~     drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe,~     well tolerated and effective in improving (raising) low levels of good cholesterol,~     high-density lipoprotein cholesterol (HDLc), as compared to placebo.~   "
259894|NCT00147966|"~     Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers~     will assess changes in the immune response that occur as a result of treatment with~     rituximab.~   "
259073|NCT00158886|"~     Patients with rectal cancer who are candidates for pre-operative radiation therapy may be~     enrolled in the Phase I, single center study. Patients will have a full blood count,~     biochemistry, urinalysis, and ECG for safety evaluation. Sequential cohorts of three patients~     will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45~     Gy) over five weeks. The starting dose of oral topotecan is 0.25 mg/m2 to be concomitantly~     administered with radiation (45 Gy) x 5 days every week unless the radiation is interrupted~     for Holidays/Weekends or toxicity requiring treatment delays occurs. A total of 25 doses are~     planned.~   "
259074|NCT00158873|"~     The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based~     regimen compared with a conventional sedative based regimen in terms of duration of~     mechanical ventilation, length of stay in ICU, difference in extubation time and use of~     concomitant sedative agents.~   "
259075|NCT00158860|"~     Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes~     simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can~     cause GH, although the latter is much more likely to produce frequent recurrences of GH~     lesions. Evidence suggests that there are advantages to using suppressive vs. episodic~     treatment, which include increased intervals between the pain and discomfort of genital~     herpes recurrences. Therefore, this study will collect safety and efficacy data on~     suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.~   "
259076|NCT00158847|"~     The hypothesis to be tested of this study is that treatment with fluticasone propionate leads~     to an initial improvement in symptoms, quality of life and lungfunction and a reduction in~     airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be~     influenced by longer lasting treatment. Addition of salmeterol will augment the initial~     benefits of fluticasone without changing the longterm decline in lungfunction.~   "
259077|NCT00158834|"~     This study was designed to evaluate if, in children with asthma, a stepwise treatment (five~     levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed~     combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores~     alone results in a sub-optimal treatment when compared to treatment based on cumulative~     symptom scores and bronchial hyperresponsiveness (PD20 methacholine).~   "
259078|NCT00158821|"~     To compare tenofovir DF plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus~     efavirenz in the treatment of HIV-1-infected patients who have never taken antiretroviral~     drugs and have a viral load of less than 400 copies/mL at week 48.~   "
259079|NCT00158808|"~     To assess the anti-PRP antibody response one month after vaccination in the groups receiving~     a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine~   "
259080|NCT00158795|"~     To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine~     co-administered with or without Chinese DTPw vaccine administered alone in healthy infants~     (3, 4 and 5 months of age)~   "
259081|NCT00158782|"~     This Phase I, dose finding study evaluates the safety and tolerability of lapatinib, a dual~     tyrosine kinase inhibitor, and GW786034, an anti-angiogenesis agent, when given together. The~     study first will find the best doses using safety and blood concentration data of both~     agents. This is done enrolling stepwise, cohorts of 3 patients each and the last patient~     enrolled must reach at least Day 22 of continuous daily dosing before the next cohort at an~     increased dose can begin. If a patient in a cohort has a dose limiting toxicity before Day~     22, then 3 more patients are studied at that same dose. If 2 of 6 patients have dose limiting~     toxicities within the first 22 days, the next cohort receives the next lowest dose. Otherwise~     each cohort has an increasing dose of one of the two agents. The second stage of the study~     will administer the best doses of the agents to about 16 patients to further study safety and~     collect more blood concentration data (more blood samples in the second phase compared to the~     first phase). The second stage has the advantage of using the best dose (decreases chance of~     receiving a sub-therapeutic dose) while it collects more blood samples and requires slightly~     more long clinic visits.~   "
259082|NCT00158769|"~     This compound, GR270773, is a lipid based compound being developed to treat Sepsis. Lipids~     are broken down in the body by the liver. This study is designed to see whether the effect of~     the drug in people with poorly functioning livers is any different to the effect on healthy~     adults.~   "
259083|NCT00158756|"~     To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant~     administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody~     response to the diphtheria antigen after a three-dose primary vaccination course.~   "
259084|NCT00158743|"~     The purpose of this study is to determine whether a commercially available anti-digoxin~     antibody, Digibind, can delay delivery in patients with severe pre-eclampsia. If so, this~     would allow more time for maternally administered steroids to prevent the development of~     respiratory complications in premature infants.~   "
259085|NCT00158730|"~     To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive~     aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in~     immunocompromised patients, as determined by overall response rates at end of course of~     treatment.~   "
259086|NCT00158717|"~     To investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B~     virus infection (HBV) who have seroconverted while participating in a previous~     Gilead-sponsored study of adefovir dipivoxil.~   "
259087|NCT00158704|"~     Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B~     virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and~     require continued access to adefovir dipivoxil.~   "
259088|NCT00158691|"~     Prospective randomized study in order to compare intravenous versus subcutaneous~     administration of amifostine in patients receiving radiotherapy for head and neck cancer.~     Salivary flow will be evaluated during few years after the treatment by a clinical~     evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.~   "
259089|NCT00158678|"~     This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy~     (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients~     with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main~     end points are the rate of locoregional control and the rate of xerostomia at 2 years.~   "
259091|NCT00158652|"~     This is a multicentric randomized phase III trial comparing conventional radiotherapy with~     concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus~     very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell~     carcinoma. The main end point is the event free survival.~   "
259092|NCT00158639|"~     The control of blood pressure (BP) for patients with hypertension on medications has been~     elusive, despite the availability of evidence-based nationally recognized guidelines for~     treatment and 30 years of research addressing this. At present, less than 50% of patients~     with known hypertension are adequately controlled. If BP control could be improved,~     significant decreases in cardiovascular morbidity and mortality would occur.~      The purpose of this study is to conduct a randomized controlled trial of the effectiveness of~     the provision of home blood pressure measurement and electronic communications (secure~     messaging to health care providers) to improve hypertension control.~   "
259093|NCT00158626|"~     The purpose of this study is to investigate the feasibility of undertaking a multi-centre~     randomised controlled trial of the effectiveness of a pelvic floor muscle training (PFMT)~     intervention for women with pelvic organ prolapse.~   "
259094|NCT00158613|"~     This study is a prospective, longitudinal, multi-center, within patient evaluation of~     patients with articular cartilage defects of the knee who have had an inadequate response to~     a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled~     in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months~     up to 48-months.~   "
259095|NCT00158600|"~     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The overall objective is to evaluate the safety, efficacy, and~     pharmacokinetics (PK) of alglucosidase alfa treatment in patients with late-onset Pompe~     disease as compared to placebo.~   "
259096|NCT00158587|"~     Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it~     accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A~     substantial proportion of clinical cases are not caused by infective bites of Anopheles spp,~     but by activation of latent hypnozoites in the liver. These relapses may significantly impede~     development since each illness may result in 5-15 days of absence from work or school.~      Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is~     beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in~     the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing,~     primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may~     be a safe and effective alternative to the traditional 14 day course of the drug. The aim of~     the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as~     effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis~     in G6PD deficient individuals.~   "
259097|NCT00158574|"~     Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan~     Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent~     preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence~     of malaria and anaemia in infants in an area with low SP resistance, low transmission~     pressure and high bednet use. However, it is not clear whether this observation can be~     generalised to areas with high transmission and high SP resistance. The mechanism of the~     protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial~     drugs that could be used for IPTi instead of SP.~      This study objectives are:~        1. Identification of a drug that could be used safely and effectively for IPTi instead of~          SP in areas, such as north eastern Tanzania, where there is a high level of resistance~          to SP and amodiaquine.~        2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a~          long acting drug (mefloquine) when used for IPTi.~        3. Investigation of the effect of the intensity of transmission on the requirements for a~          long or short acting drug for IPTi.~        4. Assessment of the effect of IPTi on the development of clinical immunity in children in~          low and high transmission areas.~      A randomised trial with four treatment regimes is proposed which will be conducted in two~     different transmission settings. The four treatment regimens are as follows: (1) placebo; (2)~     mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation~     with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a~     high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is~     the incidence of clinical malaria.~   "
259098|NCT00158561|"~     To determine whether two cheap antifolates (chlorproguanil-dapsone and~     sulfadoxine-pyrimethamine) which work against falciparum malaria in this region are~     sufficiently effective against vivax malaria to be deployed in areas where diagnosis is poor~     and the burden of malaria is high, a randomised controlled trial of the three drugs is being~     undertaken comparing their efficacy in treating malaria.~   "
259099|NCT00158548|"~     Chloroquine resistant falciparum malaria in Pakistan is prevalent in every malarious area~     examined. Resistance to the favoured second-line treatment, sulphadoxine-pyrimethamine S/P is~     rising fast. To avert a repetition of the resistance catastrophe that occurred in SE Asia it~     is critical to preserve the effective life of SP by using it in combination with artesunate.~     Efficacy of ACT with artesunate in combination with chloroquine, SP or amodiaquine for~     treatment of malaria (falciparum or vivax) will be examined in malaria patients in Pakistan.~   "
259100|NCT00158535|"~     To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the~     two-year survival after transplantation, the interaction between HCV and HIV after~     transplantation, the influence of HIV on HCV recurrence after transplantation, the~     interaction between immunosuppressive and antiretroviral drugs in particular anti-proteases,~     immunological follow-up and quality of life of these patients~   "
259165|NCT00157664|"~     The primary focus of this study is to collect information through diagnostic testing, blood~     sample analysis and patient data collection on patients starting hemodialysis to determine~     risk and preventative factors of bleeding and clotting events.~   "
259101|NCT00158522|"~     Acute hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of~     Hepatitis C Virus present in Egypt (genotype 4), has the reputation to respond poorly to~     treatment at the chronic hepatitis stage. Without treatment, 85% of patients with acute~     hepatitis C become chronically HCV infected which means that the virus stays present in the~     body. Pegylated Interferon is a new form of Interferon that stays in the body for longer time~     and allows the patient to take less injection per week. It has also proved to be more~     effective than standard Interferon in treatment of chronic hepatitis C.~   "
259102|NCT00158509|"~     Genital herpes is a long-life sexually transmitted diseases which infects a large proportion~     of women in Africa. Its clinical symptoms are painful sores on the genitals, which heals~     after a few days. HIV infection can worsen genital herpes. In turn, it is possible that~     genital herpes increases the quantity of HIV secreted at the genital level in women infected~     by the 2 viruses. This study is dedicated to verify this hypothesis.~   "
259103|NCT00158496|"~     Chronic hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type~     of HCV present in Egypt (genotype 4), has the reputation to respond poorly to Interferon~     treatment at the chronic stage. Pegylated Interferon is a new form of Interferon that stays~     in the body for longer time and allows the patient to take less injection per week. It has~     proved to be more effective than standard Interferon. The combination of two drugs,~     Interferon and Ribavirin, is considered to be the best treatment available for chronic~     hepatitis C.~   "
259104|NCT00158483|"~     Herpes virus type 2 (HSV-2) infection - as a cofactor of human immunodeficiency virus (HIV)~     transmission - can be targeted by anti-herpetic specific drugs, either as a continuous~     prophylactic treatment during its asymptomatic shedding phase, or as an episodic treatment~     during clinically-apparent genital ulcerations. The main objective of this trial will be to~     demonstrate that acyclovir treatment given during clinical episodes (primary infection or~     recurrences) can reduce genital shedding of HIV, thereby contributing to a reduction of HIV~     infectiousness of dually infected individuals (HIV+/HSV+).~   "
259105|NCT00158470|"~     Access to care and treatment using antiretroviral drugs will be expanded in Vietnam in the~     next few years. The ANRS 1210 study is a pilot program to evaluate the feasibility of a~     simplified antiretroviral treatment using three antiretroviral drugs once a day. The~     objectives will be to assess the efficacy and the tolerance of this treatment and to better~     understand the difficulties linked to social and behavioural conditions of patients at~     different stages during the treatment.~   "
259106|NCT00158457|"~     In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment~     available for HIV-1 infected patients. The combination proposed is a triple antiretroviral~     therapy with only one intake of 3 pills per day. This combination has already been studied in~     the North countries.~      Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48~     and 96 weeks of treatment.~   "
259107|NCT00158431|"~     The purpose of this trial is to evaluate the effectiveness of arthroscopy (lavage and~     debridement) in conjunction with the best available non-surgical treatment versus the best~     available non-surgical treatment alone (medication, health education and physical therapy) in~     patients with osteoarthritis of the knee.~   "
259108|NCT00158418|"~     The purpose of the study is to investigate the fixation of the humeral component in total~     shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is~     that uncemented fixation of the humerus will result in better disease-specific quality of~     life, decreased incidence of radiographic loosening, decrease operative time and no increase~     in complications.~   "
259109|NCT00158405|"~     Interrupting HAART during limited periods of time (structured treatment interruption : STI)~     could entail benefits (better long term tolerance, lower drug-induced viral resistance, lower~     cost) but also concomitant risks (lower efficacy, higher drug-induced viral resistance). At~     present, the benefit/risk ratio of STI is unclear. Several STI trials are in progress in~     industrialised countries. This trial aim at assessing the benefits and risks of two different~     STI strategies in West Africa.~   "
259110|NCT00158379|"~     Time to progression (physical examination and radiologic imaging~   "
259111|NCT00158366|"~     This study will determine the effectiveness of a group-based behavioral program for weight~     reduction in overweight and obese schizophrenia patients.~   "
259112|NCT00158353|"~     This study will be used to determine the effectiveness of GirlPOWER!, an innovative mentoring~     program for adolescent minority girls living in urban areas.~   "
259113|NCT00158340|"~     This study will determine the effectiveness of guided self-help treatment in treating~     individuals with binge eating disorder (BED).~   "
259114|NCT00158327|"~     This study will determine the impact of a telephone-based care management program for primary~     care patients with panic disorder or generalized anxiety disorder.~   "
259115|NCT00158314|"~     This study will determine the effectiveness and cost-effectiveness of three different~     treatment strategies in reducing gambling behaviors.~   "
259116|NCT00158301|"~     This study will determine the effectiveness of cognitive behavioral therapy in preventing a~     relapse of depressive symptoms in children.~   "
259117|NCT00158288|"~     Although LAAM, a derivative of methadone, has been successfully used as an alternative to~     methadone maintenance in opioid addicts, its effect on concurrent opioid and cocaine abuse~     has not been ascertained. Thus, this study proposes to examine the clinical efficacy of low-~     and high-dose LAAM maintenance on opioid and cocaine use in opioid-dependent cocaine abusers.~     In addition, since contingency management procedures have demonstrated some success in~     decreasing cocaine use in cocaine-abusing individuals, this study also proposes to examine~     the clinical efficacy of the presence or absence of contingency management procedures~     targeting illicit drug use.~   "
259118|NCT00158275|"~     This study will determine the effectiveness of an intervention consisting of combined~     strategies in reducing the symptoms of both depression and chronic back pain.~   "
259119|NCT00158262|"~     This study will assess the effectiveness of taking propranolol soon after a traumatizing~     incident in reducing the incidence and severity of posttraumatic stress disorder in acutely~     traumatized individuals.~   "
259166|NCT00157651|"~     This study examines whether low intensity, dose adjusted warfarin prolongs the time to~     mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of~     bleeding.~   "
259120|NCT00158249|"~     The Three Aims of this study are (only studies for Aim 1 were completed)~        1. Measure the impact of citicoline on marihuana use patterns in subjects' individualized~          natural settings and responses to marihuana challenge using functional brain MRI scans.~           Hypothesis - 2 g/day citicoline will produce greater reductions in marihuana use and~          craving in heavy marihuana users than placebo citicoline over a 8-week treatment period~          as measured in their natural environments. The same participants will experience greater~          improved brain activation patterns and an improvement in cognitive functioning compared~          to placebo controlled subjects.~        2. Measure the effects of citicoline on marihuana absorption and metabolism and determine~          if these changes parallel changes in subjective and physiological responses in a~          laboratory setting.~           Hypothesis - Chronic (8 weeks) treatment with 2 g/day citicoline will produce increases~          in subjective and physiological effects of both acute marihuana smoking and placebo~          marihuana smoking compared to chronic placebo citicoline. Citicoline will have no effect~          on marihuana pharmacokinetics.~        3. Measure the effects of citicoline on marijuana-induced cue-induced craving and brain~          electrical activity (EEG).~      Hypothesis - Chronic (8 weeks) treatment with 2 g/day citicoline will reduce objective~     measures of marijuana cue-reactivity, and subjective reports of craving in response to~     marihuana cues will also be attenuated compared to chronic placebo citicoline treatment.~   "
259121|NCT00158236|"~     Buprenorphine is a medication used to treat opioid addiction, but individuals who use this~     drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the~     likelihood of buprenorphine addiction. This study will evaluate the potential for abuse of~     buprenorphine and a buprenorphine and naloxone combination in non-dependent opioid users.~   "
259122|NCT00158223|"~     This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in~     the treatment of schizophrenia.~   "
259123|NCT00158210|"~     Methamphetamine abuse has been steadily increasing over the past decade. Rivastigmine is a~     medication that may be helpful in treating methamphetamine dependence. The purpose of this~     study is to evaluate the effectiveness of rivastigmine in treating methamphetamine dependent~     individuals.~   "
259124|NCT00158197|"~     The purpose of this study is to determine if different reinforcement procedures (i.e.,~     schedules) produce different patterns of long-term abstinence from methamphetamine. We~     anticipate that the three contingency management conditions will promote longer periods of~     abstinence in the year following treatment relative to the standard control group.~     Furthermore, we predict that the intermittent reinforcement procedures will produce longer~     periods of continued abstinence (i.e., long-term behavior change) in the year following~     treatment than the continuous reinforcement procedure. Finally, we predict that the~     intermittent unpredictable schedule will produce longer lasting behavior change than the~     intermittent predictable schedule. Methamphetamine use will be measured using urine~     toxicology and self-report of methamphetamine use.~   "
259125|NCT00158184|"~     The purpose of this study is to examine the abuse liability of oxycodone in individuals with,~     and without, a history of prescription opioid abuse.~   "
259126|NCT00158171|"~     Currently one in five high school students smokes. Smoking can harm adolescents well before~     they reach adulthood by causing a number of immediate, sometimes irreversible, health risks~     and problems. This study will compare the effectiveness of treatment with bupropion, a~     nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers.~   "
259127|NCT00158158|"~     Currently one in five high school students smoke. Smoking can harm adolescents well before~     they reach adulthood by causing a number of immediate, sometimes irreversible, health risks~     and problems. This study will examine whether reducing smoking will facilitate quitting~     smoking in adolescents who have unsuccessfully attempted to quit smoking~   "
259128|NCT00158145|"~     Lung cancer is the leading cause of cancer death in the United States. Currently it remains~     impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a~     mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and~     metabolism are a useful tool and available to use. The purpose of this study is to assess the~     variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.~   "
259129|NCT00158132|"~     Cocaine addiction is a serious health problem with no available medical treatment for~     preventing relapse. Amantadine, a medication that improves muscle control, and propranolol, a~     medication that lowers blood pressure, may be useful in treating cocaine addiction in~     individuals with severe cocaine withdrawal symptoms. This study will evaluate the~     effectiveness of amantadine and propranolol in preventing drug relapse among cocaine addicts.~   "
259130|NCT00158119|"~     The purpose of this study is to evaluate two types of exercise therapy designed to improve~     muscle power and mobility: weighted vest exercise vs. progressive resistance training.~   "
259131|NCT00158106|"~     This study investigates the effectiveness and cost-effectiveness of speech and language~     therapy for adults who suffer communication difficulties following a stroke.~   "
259132|NCT00158093|"~     Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the~     treatment of high blood pressure, angina, abnormal heart rhythms and following a heart~     attack. The purpose of this study is to explore the potential of nebivolol to cause a certain~     type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause~     this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved~     by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known~     to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working~     hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals~     measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.~   "
259133|NCT00158080|"~     Contrast-induced acute renal failure can be prevented with hemofiltration which is performed~     during cardiac catheterization~   "
259134|NCT00158067|"~     This feasibility clinical investigation is designed to demonstrate that the NeuroPace~     external Responsive Neurostimulator (model eRNS-300) can safely deliver responsive electrical~     stimulation automatically to affect epileptiform activity. The eRNS-300 is based on an~     implantable neurostimulator that has been adapted for acute, external use in a hospital~     setting.~   "
259895|NCT00147953|"~     This study aims to assess the short term efficacy of a combination of rituximab and low-dose~     radiotherapy in patients with non-Hodgkin's lymphoma.~   "
259135|NCT00158054|"~     The specific aim of the Coronary Patients Evaluation Study (COPES) Project 2 is, within a~     Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction~     associated with treatment for symptoms of distress and/or depressed mood among post acute~     coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of~     this study, symptoms of distress and/or depressed mood is defined by a score on the Beck~     Depression Inventory (BDI) >10. The specific treatment approach utilized follows the,~     Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) Clinical Trial, and~     involves up to 6-months of a patient preference, stepped-care protocol. Within this protocol,~     patients choose between brief, problem focused psychotherapy and anti-depressant medication.~     Treatment progress is reviewed at 2-month intervals, providing opportunities to 'step-up'~     treatment if patients are not demonstrating sufficient symptom reduction.~   "
259136|NCT00158041|"~     Amifostine is a radioprotective drug which is approved by the US FDA for administration prior~     to each radiation treatment using the intravenous route. The study evaluated the safety of~     amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting,~     hypotension, generalized skin rash, and injection-site skin reactions.~   "
259137|NCT00158028|"~     The purpose of this study is to determine the efficacy of risperidone compared to placebo in~     the treatment of the psychotic-like and deficit symptoms of schizotypal personality disorder~     (SPD). Treatment with risperidone, a 5HT2 and dopamine D2 blocking agent, holds particular~     promise in the treatment of SPD. Unlike traditional antipsychotics, risperidone targets the~     deficit or negative symptoms of schizophrenia. The deficit-like symptoms of SPD are therefore~     also likely respond to treatment with risperidone. One common complication in the present~     psychopharmacologic treatment of SPD with traditional neuroleptics is the fact that many~     patients discontinue treatment due to the medication-induced dysphoria. Given initial reports~     and the serotonergic component of the risperidone mechanism, risperidone is anticipated to~     produce little or no dysphoria.~   "
259138|NCT00158015|"~     The purpose of this study is to assess whether tissue doppler imaging is useful in predicting~     which patients will respond most to Cardiac Resynchronization therapy ( a type of pacemaker)~   "
259139|NCT00158002|"~     The objective of this study is to assess the long-term safety and effectiveness of topiramate~     in the prevention of basilar and hemiplegic migraine in children and adolescents.~   "
259140|NCT00157989|"~     QUESTION:~      Is controlled tidal volume delivery during the resuscitation of preterm infants < 28 weeks’~     gestation safe and feasible?~      BACKGROUND AND RATIONALE: Current resuscitation of preterm neonates follows the Neonatal~     Resuscitation Program (NRP) guidelines. During initial resuscitation, neonates are bagged~     with self/flow inflating bags to achieve adequate chest rise, heart rate > 100 per minute and~     a pink color. When positive pressure ventilation is delivered with a bag, tidal volume is not~     measured. It is likely that high tidal volume is delivered to the neonate in order to achieve~     a rapid response. The evidence from human and animal model studies suggests that the~     initiation of mechanical ventilation and volutrauma associated with continued ventilation,~     are associated with an increase in pro-inflammatory mediators in the lungs of the preterm~     infants which induce pulmonary injury. This may interfere with the signaling involved in~     alveolarization, leading to a decrease in alveolar formation or maldevelopment of the~     alveoli, and subsequent evolution to chronic lung disease (CLD) or bronchopulmonary dysplasia~     (BPD).~      OBJECTIVE: To evaluate the safety and feasibility of controlling tidal volume delivery (and~     limiting manual ventilation), during the resuscitation of preterm infants < 28 weeks’~     gestation.~      STUDY DESIGN AND SETTING: A randomized controlled pilot study of 40 preterm neonates at the~     Mount Sinai Hospital.~      RESEARCH PLAN: All eligible parents at risk for preterm delivery at < 28 weeks’ gestation~     will be approached. After obtaining written informed consent, infants will be randomized to~     standard resuscitation according to NRP guidelines (control group) or resuscitation using~     controlled tidal volume ventilation (5 ml/kg) (study group), if they require resuscitation.~     Crossover to the control group will be allowed if there is clinical deterioration or no~     clinical improvement after 3 minutes of intervention.~      OUTCOMES:~        1. Primary: Apgar scores at 5,10, 15 and 20 minutes and pH, pO2, and pCO2 levels within 1~          hour of resuscitation and at 4 hours of life.~        2. Secondary: Durations of mechanical ventilation, continuous positive airway pressure~          support, low flow oxygen/air requirement; respiratory status of infant at 28 days~          postnatal and 36 weeks’ corrected gestational age. Incidences of air leak,~          intraventricular haemorrhage and all causes of mortality before discharge from NICU will~          be compared.~   "
259141|NCT00157976|"~     The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX)~     photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal~     neovascularization (CNV) associated with age-related macular degeneration (AMD).~   "
259142|NCT00157963|"~     An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to~     amlodipine at week 12 in Korean patients with essential hypertension~   "
259143|NCT00157950|"~     This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age~     in Korea.~   "
259144|NCT00157937|"~     Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week~     wash-out period and 8-week comparator drug or the drug administration period (with cross-over~     design) for assessment of the drug efficacy, safety and tolerability.~   "
259145|NCT00157924|"~     An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6~     in diabetics or metabolic syndrome patients in Korea.~   "
259146|NCT00157911|"~     Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period.~     Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes~     approximately 18 weeks for an individual patient to complete including post-visit at week 14.~   "
259147|NCT00157898|"~     This was a prospective, randomized, controlled, open, and multi-center trial conducted to~     compare the clinical efficacy and safety of ertapenem with it's comparator before or~     following adequate surgical management of complicated intra-abdominal infection.~   "
259148|NCT00157885|"~     The primary aim of the comparative trial is to assess the relative safety and efficacy of two~     artemisinin containing regimens: amodiaquine plus artesunate (AAQ) and artekin both~     administered once daily for 3 days.~   "
259149|NCT00157872|"~     A study to compare rofecoxib versus naproxen in the treatment of Chinese patients with~     rheumatoid arthritis.~   "
259150|NCT00157859|"~     Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent~     in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial~     protocols in Papua, Indonesia, consecutive patients presenting to a rural clinic were~     enrolled into a prospective efficacy study. Patients with uncomplicated falciparum malaria~     were treated with chloroquine plus sulfadoxine-pyrimethamine and those with vivax malaria~     with chloroquine monotherapy. Patients failing therapy received unsupervised oral quinine +/-~     doxycycline for 7 days. Follow-up was continued for 42 days for falciparum malaria and 28~     days for vivax malaria.~      The study hypothesis was that current recommended antimalarial protocols were no longer~     effective.~   "
259151|NCT00157846|"~     The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients~     who need antibradycardia ventricular stimulation (more than 80%); are eligible for the~     exchange of an old pacemaker or implantable cardioverter defibrillator (ICD); and have~     ventricular dysfunction (left ventricular ejection fraction [LVEF] < 35%). All patients~     eligible for participation in the study will be upgraded with a cardiac resynchronization~     therapy (CRT)-device and receive either right ventricular or biventricular stimulation in a~     crossover protocol. The endpoint is functional performance measured by spiroergometry.~   "
259152|NCT00157833|"~     This open randomized, parallel group, 6 week trial in two rural outpatient clinics will~     compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin~     regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and~     children (>10kg).~   "
259153|NCT00157820|"~     The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to~     analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as~     compared to single chamber ICD in a non selected population with conventional indication of~     ICD implantation.~   "
259154|NCT00157807|"~     The clinical effects of intra-operative radiofrequency ablation in patients with persistent~     or permanent atrial fibrillation and an indication for an implantation of a heart valve~     prosthesis or coronary bypass surgery are the purposes of this study. The study will examine~     if and to what extent the quality of life and the use of medical care differs between~     patients with and without ablation. Furthermore, there will be thorough echocardiographic~     examinations of the heart to detect differences between the different treatment groups. The~     patients will be followed for one year after treatment.~   "
259155|NCT00157794|"~     Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases~     where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that~     pacing even might have unfavourable effects, especially if patients suffer from additional~     cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid~     ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental~     effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the~     amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial~     fibrillation and the usage of drugs in patients treated with pacemakers with an activated~     Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker~     settings to minimize the amount of right ventricular pacing.~   "
259156|NCT00157781|"~     The purpose of the study is to demonstrate the efficiency on AT / AF prevention and~     termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in~     patients with conventional pacemaker indications.~   "
259157|NCT00157768|"~     Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die~     of sudden cardiac death in the following 2 years. The prognosis appears not improved by~     medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol~     CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well~     established. On the other hand, an implantable defibrillator (ICD) proved to be superior to~     medication when used for secondary prevention in patients after cardiac arrest. The question~     arises whether ICD therapy is also effective in primary prevention in high risk patients~     after acute myocardial infarction. This study determines if patients, who were defined as~     high risk patients in the early post infarction phase by means of noninvasive methods,~     benefit from primary prevention by means of an ICD. Special emphasis is put on an individual~     optimization of the infarction therapy, including beta-blockers.~   "
259158|NCT00157755|"~     This study is to evaluate the safety and effectiveness of gastric stimulation in the~     reduction of nausea and vomiting in patients with gastroparesis using an approved~     Humanitarian device. There are two cohorts in this study based on etiology, one for diabetic~     and one for idiopathic.~      A maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the United~     States will be followed closely for twelve months and then once a year after that until the~     study closes.~      If you are someone suffering with symptoms of gastroparesis despite trying oral medications,~     you may be eligible to participate in a clinical study using a surgically implanted gastric~     stimulator.~   "
259159|NCT00157742|"~     Randomised trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser~     Revascularisation (PMR) in patients with Refractory Angina Pectoris.~      Hypothesis: difference in exercise tolerance at 12 months between SCS and PMR~   "
259160|NCT00157729|"~     The purpose of this study is to determine whether MC-1 alone and in combination with an ACE~     inhibitor is effective in reducing blood pressure and metabolic dysfunctions associated with~     diabetes~   "
259161|NCT00157716|"~     The purpose of this study is to determine whether MC-1 is effective and safe in reducing~     cardiovascular and neurological events in patients undergoing high-risk coronary artery~     bypass surgery~   "
259162|NCT00157703|"~     This is an open-label, single site study to evaluate the safety and tolerability of~     intratumoral administration of G207 followed by treatment with radiation therapy in patients~     with recurrent/progressive malignant glioma.~      This study is a two stage phase 1 study, in which a de-escalating dosing scheme will be used,~     i.e. the first patients will receive the higher dose and if excessive toxicity occurs, the~     dose will be reduced for the following patients. The purpose of the dose de-escalation phase~     is to find the best safe dose of G207.~      In the first stage of the study, treatment with G207 will be followed by focal radiation~     therapy on the following day, and in the second stage treatment with G207 will be followed by~     gamma knife surgery also on the following day.~      All patients will return to the clinic 28 days and 3, 6, 9 and 12 months after G207~     administration at which time clinical assessments will be performed, and will be followed for~     safety and survival at clinic visits or by telephone every 3 months for up to 2 additional~     years and annually thereafter.~   "
259163|NCT00157690|"~     The primary objective of this study is to determine efficacy of 70 mg alendronate once weekly~     compared to placebo. This will be measured by percent changes in lumbar spine(LS) bone~     mineral density(BMD) in adult cystic fibrosis(CF)patients after one year of treatment. The~     investigators hypothesize that in adult CF patients with osteopenia or osteoporosis,~     alendronate 70 mg once weekly will produce a mean increase from baseline in lumbar spine BMD~     that is greater than that observed with placebo at 12 months.~   "
259167|NCT00157638|"~     Recent health policy documents have endorsed an integrated model of collaboration between~     pharmacists and physicians in primary care. The integration of pharmacists into primary care~     has been identified as a priority for primary health care reform in Canada. However, the best~     way to do this has not been demonstrated or evaluated. This demonstration project shows the~     various ways in which pharmacists can be trained and integrated into different family~     practice settings, the processes and costs associated with doing this, and the outcomes~     observed. The main hypothesis is that pharmacist integration into family practice will~     optimize medication use, clinical care and clinical outcomes. This information provides~     policy makers with necessary information about collaboration between pharmacists and family~     physicians for their overall goal of reforming the delivery of primary health care to the~     population.~   "
259168|NCT00157625|"~     Urinary tract infections are the most common type of hospital-acquired infection. The~     majority of these infections result from the use of indwelling urinary catheters. Often~     caregivers leave them in unnecessarily. The purpose of this study is to assess the~     effectiveness of an automatic stop order (automatic removal or urinary catheters when they no~     longer needed) in reducing urinary infections.~   "
259169|NCT00157612|"~     Nursing home residents are frequently transferred to hospital for management of pneumonia.~     This often leads to hospital related complications and is a burden on the acute care health~     system. The purpose of this study is to assess whether managing residents with pneumonia and~     lower respiratory tract infection on site in the nursing home can reduce hospital admissions~     and can reduce complications and improve quality of life for residents. We have randomized~     residents with nursing home acquired pneumonia to on-site management, using a clinical~     pathway, versus usual care.~   "
259170|NCT00157599|"~     To determine whether treatment and further investigation can be safely withheld in patients~     who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i)~     negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.~   "
259171|NCT00157586|"~     Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in~     many developed and newly industrialized nations. Diabetes mellitus represents the single~     largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the~     primary cause of early death in diabetic patients are cardiovascular complications.~     Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi)~     and calcium channel blockers (CCBs) have a specific renoprotective effect and that this~     effect can be magnified when the two drugs are used in combination. To formally test this~     hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND)~     study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years~     treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10~     mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss~     and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric~     hypertensive type 2 diabetic patients.~   "
259172|NCT00157573|"~     Granulocyte macrophage colony-stimulating factor (GM-CSF) is an immunostimulant and~     preliminary data suggests it may change the natural history of prostate cancer and melanoma.~     This study looks at ability of GM-CSF to alter disease progression in women who have~     recurrent but asymptomatic recurrence of their ovarian cancer.~   "
259173|NCT00157560|"~     Over the last few years several novel agents have been defined which are active in the~     treatment of relapsed epithelial ovarian carcinoma. Many of these new agents seemed to have~     mechanisms of action that are different from Carboplatin and taxol. This trial looks to~     evaluate the effectiveness and toxicity of three sequential chemotherapy doublets in the~     treatment of women with newly diagnosed ovarian, primary peritoneal or tubal carcinoma.~   "
259174|NCT00157547|"~     The purpose of the study is to try to see if antidepressant medications cause changes in QEEG~     measurements in the brain. QEEG is a mathematical analysis of electrical currents in the~     brain using electrodes placed on the scalp. Previous studies have shown that mood improvement~     (clinical response) caused by antidepressant medications was preceded by changes in QEEG~     measurements in the brain.~   "
259175|NCT00157534|"~     The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks~     in patients with chronic hepatitis C genotype 1 infection.~   "
259176|NCT00157521|"~     Pre-eclampsia is a disorder unique to pregnancy affecting both the mother and the fetus.~     Hypertension, proteinuria and edema are the most common and well-known maternal clinical~     symptoms. The incidence is approximately 6-8%. Pre-eclampsia is one of the leading causes of~     maternal and fetal mortality and morbidity associated with pregnancy throughout the world.~     The pathophysiology is unknown. At present, the most effective treatment is immediate~     delivery.~      The researchers' studies contributed to the demonstration that the vasodilator nitric oxide~     (NO) is important for correct placentation and that less nitric oxide (NO)- dependent~     vasodilation and an excess formation of reactive oxygen species explain poor placenta~     perfusion in pre-eclampsia. This reduced NO activity and increased oxidative stress in~     pre-eclamptic placenta is related to low bioavailability of L-arginine, the NO precursor.~      In this pilot study the researchers want to evaluate whether the administration of L-arginine~     to women with a clinical diagnosis of preeclampsia might restore physiological NO production~     in the placenta and ameliorate the pregnancy outcome.~   "
259177|NCT00157508|"~     Aspirin is commonly used for treatment of painful and inflammatory diseases and in the~     prevention of the cardiovascular disease. A major drawback of aspirin treatment is the well~     recognized gastrointestinal toxicity. Recent research indicate that coupling a nitric oxide~     (NO)derivate to the aspirin moiety retains its therapeutic effects while avoiding its~     undesirable gastrointestinal side effects. NO has cytoprotective effects, such as blood flow~     modulation, mucus release and repair of mucosal injury. NCX4016, a NO-releasing derivative of~     acetylsalicilic acid, has been shown to retain the analgesic, anti-inflammatory and~     antithrombotic activity of aspirin, but with less gastrointestinal toxicity. In addition,~     preliminary data suggested that NCX4016 may restore insulin sensitivity in eNOS deficient~     mice.~      This study was aimed to evaluate the activity of NCX4016, compared to aspirin, on~     albuminuria, insulin sensitivity and cardiac and renal hemodynamic in patients with type 2~     diabetes mellitus. The patients after one month of placebo treatment, entered two 1-month~     treatments periods, with equivalent doses (800 mg of NCX4016, 325 mg of aspirin) of NCX4016~     or aspirin.~   "
259178|NCT00157482|"~     Diabetes mellitus is becoming a global epidemic burden. Its chronic cardiovascular~     complications, myocardial infarction and stroke, are the main causes of death in diabetic~     patients. It was found that low density lipoprotein (LDL) cholesterol concentration is~     related to the increased coronary disease risk that could be successfully reduced by~     cholesterol-lowering therapy. Furthermore, preliminary evidence suggests that ameliorating~     dyslipidemia may be renoprotective in diabetic patients with proteinuria.~      Ezetimibe is the first selective inhibitor of cholesterol absorption and it has demonstrated~     a high efficacy in lowering cholesterol concentration and an excellent safety profile.~     Preliminary data suggest that ezetimibe, combined with a drug that blocks the cholesterol~     synthesis (statins), could be even more effective in decreasing cholesterol concentration.~     The aim of this study is to evaluate whether ezetimibe-simvastatin combined therapy is~     superior to simvastatin monotherapy in ameliorating the lipid profile and albuminuria in type~     2 diabetic patients.~   "
259179|NCT00157378|"~     The study is a multicenter, double-blind, randomized, parallel-group study with first episode~     schizophrenic patients. During a treatment phase of 8 weeks the patients are treated with~     Risperidone or Haloperidol. Aim of the project is to compare the effects of the atypical~     neuroleptic Risperidone with those of the conventional neuroleptic Haloperidol and to~     evaluate whether the assumed advantages of atypical neuroleptics compared to conventional~     neuroleptics are also present when both medications are administered in rather low daily~     dosages (min. 2 mg/d; max. 8 mg/d).~   "
259180|NCT00157339|"~     Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the~     Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2~     diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month~     follow up period.~   "
259181|NCT00157326|"~     Purpose: The primary objective of this study is to evaluate the efficacy and safety of~     tadalafil when administered once daily at doses of 5 and 20 mg to adult subjects for 8 weeks~     with mild to moderate hypertension.~   "
259182|NCT00157313|"~     The purpose of the study was to evaluate the effects of integrated treatment for patients~     with a first episode of psychotic illness. We conducted a randomised clinical trial in~     Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547~     patients with first episode of schizophrenia spectrum disorder, who has not received~     antipsychotic medication for more than 12 weeks.~      Patients were randomised to integrated treatment or standard treatment. The integrated~     treatment lasted for two years and consisted of assertive community treatment with programmes~     for family involvement and social skills training. Standard treatment offered contact with a~     community mental health centre.~      We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack~     of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one~     and two years' follow-up.~      We found that integrated treatment improved clinical outcome and adherence to treatment. The~     improvement in clinical outcome was consistent at one year and two year follow-ups. We will~     study further outcome measures such as social network, quality of life, depression and~     suicidal behaviour.~   "
259183|NCT00157300|"~     Randomized, double blind, placebo controlled, prospective trial investigating the effect of~     erythropoietin in renal transplantation.~      The investigators postulate that erythropoietin reduces the risk of delayed graft function.~   "
259184|NCT00157287|"~     Protocol directed weaning has been shown to reduce the duration of mechanical ventilation for~     patients admitted to the intensive care unit (ICU) of tertiary centres. However, this benefit~     has not previously been studied in a community hospital setting. We therefore sought to~     evaluate the impact of an evidence-based weaning guideline on the outcomes for patients~     receiving mechanical ventilation in the ICUs of community hospitals in a cluster randomized~     controlled trial involving 11 community hospitals.~   "
259185|NCT00157274|"~     The investigators designed a compassionate basis phase II study for refractory/relapsed~     mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation~     of overall response and time to relapse. Other goals to consider are toxicity and time to new~     therapy.~   "
259186|NCT00157261|"~     The general aim of this study is to compare the efficacy and safety of tenecteplase to~     standard treatment during cardiopulmonary resuscitation in patients suffering from~     out-of-hospital cardiac arrest.~   "
259187|NCT00157248|"~     To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial~     fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).~   "
259188|NCT00157235|"~     The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva,~     Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance~     seen in patients with chronic obstructive pulmonary disease (COPD) who participate in~     pulmonary rehabilitation.~   "
259189|NCT00157222|"~     The condition Charcot foot has been known in more than 130 years, and yet there still remains~     a large effort to find the cause, diagnostic and medical treatment of the condition.~      Charcot neuroarthropathy is a progressive disease of bone and joints characterized by~     often-painless bone and joint destruction in limbs that have lost sensory innervation. The~     incidence of acute Charcot among diabetic patients is 0,2 % the prevalence is 7,5 %. In the~     group of patients with neuropathy the prevalence is even higher –29%.~      The diagnosis is often made on a clinical basis, particularly in the early stages of the~     condition. The aim of this study is to find a method that makes the diagnosis primarily on~     the basis of paraclinical information.~      Clinical presentation:~      The typical patients have had diabetes in 10 years and have distal symmetrical neuropathy.~      The common lesion is unilateral with an acute phase, which may occur either spontaneously or~     be triggered by a minor trauma. The foot becomes swollen, warm, red and oedematous. Some~     patients have pain, and the condition could be misdiagnosed as cellulites, acute gout, deep~     vein thrombosis and osteomyelitis. If the patient has a foot ulcer it is important to rule~     out osteomyelitis and cellulites.~      In the initial phase it is difficult to make the right diagnose because Charcot is a rare~     condition. This leads to a delay in the treatment of the Charcot foot, which, for the moment,~     is reduction of weight bearing. The patient is equipped with an air cast, and the non~     weight-bearing regime is in some cases maintained in 12 months.~      The chronic Charcot is characterized by established deformity. The deformity can be in~     different sites in the foot, the most common is in the mid foot. Because of the deformity~     there is abnormal weight pressure on the weight bearing sites on the foot. This is associated~     with callus formation and there is a higher risk for ulceration.~   "
259240|NCT00156533|"~     We want to assess whether how and when one takes sleep medication results in similar or~     different outcomes with respect to symptom relief. We also want to know whether taking~     medication for a period of time provides continued benefit once the medication is stopped.~   "
259365|NCT00154882|"~     The primary endpoint of this phase II trial is the objective response rate of the stage I~     (low-dose) regimen. The secondary endpoints include treatment-related toxicity, the change in~     quality of life, progression free survival and overall survival.~   "
259190|NCT00157209|"~     This is a prospective open label, controlled, randomized study to test the safety and~     efficacy of active specific immunotherapy with tecemotide (L-BLP25) for the treatment of~     subjects with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC). To be eligible,~     subjects entering the trial will have to demonstrate either stable disease or a clinical~     response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy)~     and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.~     Following a 3 week washout period, subjects will be stratified by disease status (either~     Stage IIIB locoregional disease or Stage IIIB with malignant pleural effusion and Stage IV),~     and randomized to either best supportive care (BSC) plus tecemotide (L-BLP25) treatment or~     BSC alone.~   "
259191|NCT00157196|"~     The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation~     in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This~     population includes Stage IIIA NSCLC subjects, a population not studied in former clinical~     studies with this vaccine. The secondary objective is to document the survival of subjects~     treated.~   "
259192|NCT00157183|"~     The purpose of this study is to determine whether correction of low nighttime oxygen (O2)~     levels and/ or high carbon dioxide levels in patients with cystic fibrosis improves their~     quality of life. The treatments being used overnight are (1)O2 (2)pressurised air which~     assists breathing (non-invasive positive pressure ventilation, NIPPV)~   "
259193|NCT00157170|"~     To evaluate the impact of a supervised exercise program (SEP) on self-efficacy,quality of~     life status and cardiovascular fitness among people with HIV in a 24 week randomised~     controlled trial.We hypothesised that a combined aerobic and resisted exercise (intervention)~     would improve these parameters compared to an individual walking program with monthly group~     forum (control).~   "
259194|NCT00157157|"~     The purpose of this study is to evaluate whether Antihemophilic factor, recombinant,~     manufactured protein-free (rAHF-PFM) is effective and safe in the treatment of hemophilia A~     patients who have not been treated with factor VIII (FVIII) before.~   "
259195|NCT00157144|"~     Extracorporeal membrane oxygenation (ECMO) is a means of artificially performing the function~     of the human lung and/or heart outside the body. Its use is escalating in a wide range of~     clinical settings in the adult population without evidence or guidelines to support this~     practice.~      This study involves a nationwide questionnaire which has two components. The initial pilot~     survey will attempt to identify all institutions currently practicing ECMO or those intending~     to do so in the future, and are willing to participate in prospective data collection. The~     second phase will involve a monthly survey of these centres regarding the extent of ECMO use,~     practice details implemented, and outcome data.~      It is hoped that the collection of this information will later assist in the development of~     guidelines for this expensive and presently unsubstantiated practice, together with the~     construction of appropriate training programs for staff.~   "
259196|NCT00157131|"~     The primary objective of this study is to evaluate skin graft adherence and wound healing in~     burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current~     standard of care (staples). The primary endpoint is achievement of complete (100%) wound~     closure within 28 days.~   "
259197|NCT00157118|"~     The purpose of this study is to show that Protein C Concentrate is a safe and effective~     treatment for subjects with congenital protein C deficiency. Depending on the type of~     treatment required, patients are assigned to one of 3 study parts: Part 1 is for the~     treatment of acute episodes, Part 2 is for short-term prophylaxis, and Part 3 is for~     long-term prophylaxis in infants aged less than 6 months only.~   "
259198|NCT00157105|"~     The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the~     treatment of hemophilia A patients undergoing surgery.~   "
259199|NCT00157092|"~     The study was a Phase 1B/2A, uncontrolled, open-label, single-center study in individuals~     with congenital AAT (alpha 1-antitrypsin) deficiency. A baseline bronchoscopy with~     bronchoalveolar lavage (BAL) was performed 3 to a maximum of 4 weeks prior to the first~     administration of study drug. Fifteen eligible subjects were randomized to receive 1 of 3~     dosing regimens of rAAT (100 mg daily, 100 mg twice daily, or 200 mg daily) administered via~     nebulization for 7 consecutive days. A post-treatment nadir BAL was obtained on study Day 8~     (12 hours after last dose for subjects who receive drug therapy twice daily and 24 hours~     after the last dose for subjects who receive study product daily). BALs were conducted in the~     same lung lobe/segment. Follow-up visits took place on Day 15 and Day 36.~   "
259200|NCT00157079|"~     The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous~     (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.~   "
259201|NCT00157066|"~     The purpose of this study is to determine how vitamin D supplementation (ergocalciferol)~     affects the immune response to mycobacterial infection.~   "
259202|NCT00157053|"~     The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the~     treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a~     pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The~     study is open to patients who completed Baxter Study 069901.~   "
259203|NCT00157040|"~     The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the~     treatment of children with hemophilia A. The study consists of 2 parts. Part 1 of the study~     is a pharmacokinetic evaluation, and Part 2 is an evaluation of efficacy and safety.~   "
259204|NCT00157027|"~     The objectives of this clinical trial are to:~        -  Assess the safety of using extracorporeal photoimmune therapy with the photosensitizing~          agent Uvadex in the treatment of HIV-1 infection;~        -  Evaluate the effects of this therapy on HIV-1 viral load by polymerase chain reaction~          (PCR) analysis;~        -  Evaluate the effects of this therapy on CD4+, CD8+ cells and CD4/CD8 ratio;~        -  Evaluate the effects of this therapy on the patient's immune system, by skin reactivity~          to a standard anergy panel.~   "
259205|NCT00157014|"~     The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart~     transplantation.~   "
259423|NCT00154128|"~     The study was designed to investigate a possible influence of an occlusal stabilization~     splint on the body posture in TMD cases and controls. Interocclusal appliances or occlusal~     splints are therapeutic devices that are most frequently used in the treatment of TMD.~     Changes of the mandibular position and occlusal equilibrations are assumed to have an impact~     on the general body posture.~   "
259206|NCT00157001|"~     The primary objective of the study is to evaluate the difference in 6-month restenosis rates~     in coronary artery lesions treated by photopheresis in addition to angioplasty with stent~     placement, as opposed to no photopheresis after angioplasty and stent placement. Restenosis~     means the closing up again, or narrowing in diameter, of the previously treated artery, which~     may cause reduced blood flow and the re-occurrence of symptoms. Photopheresis is a~     therapeutic technique in which a portion of your white blood cells is collected by a blood~     separation device and exposed to ultraviolet A light, in combination with the drug 8-MOP~     (8-methoxypsoralen), then returned to you.~      The secondary objectives are:~        1. To compare the incidence of major adverse cardiac events (MACE) between the three~          treatment groups for 6 months post-angioplasty. MACE events include death (cardiac~          related), myocardial infarction, coronary artery bypass graft surgery, repeat~          angioplasty to the target vessel, hospitalization and clinical symptoms.~        2. To evaluate the safety of the treatment by comparing the incidence of acute and subacute~          thrombosis, bleeding and vascular complications and other non-MACE events every 2 weeks~          for 6 months post-angioplasty between the three treatment groups.~   "
259207|NCT00156988|"~     The objective of the proposed study is to assess whether the application of flammacerium for~     2 days is as good as, or even better than, the application of flammacerium for 10 days~     regarding woundhealing in partial thickness burns.~   "
259208|NCT00156975|"~     Primary endpoint of the study is to prove the superiority of an adjuvant therapy with~     oxaliplatin/ capecitabine until the first occurrence of appearance of a tumour. Occurrences~     in the meaning of this study are the appearance of a relapse of the tumour, of metastases, of~     a second tumour or death of any reason.~   "
259209|NCT00156962|"~     The purpose of this study is to look at subject incidence of adverse events.~   "
259210|NCT00156949|"~     Subject incidence of adverse events~   "
259211|NCT00156936|"~     This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to~     assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All~     subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).~      Planned treatment duration was up to 3 years. Alkermes terminated the study for business~     purposes in December 2006. The median duration of treatment among all subjects in this~     extension study was 43 weeks.~   "
259212|NCT00156923|"~     This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to~     further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone~     (VIVITROL®).~   "
259213|NCT00156910|"~     This is a 60 week study including a double-blind phase followed by an open-label extension~     phase.~   "
259214|NCT00156897|"~     The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic~     patients and whether its safety and tolerability profile is superior to that of orlistat in~     such patients~   "
259215|NCT00156884|"~     This study is designed to determine whether the combination of low dose cisplatin and~     strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in~     hormone refractory prostate cancer.~   "
259216|NCT00156871|"~     The purpose of this study is to investigate the impact of fatigue in severely affected~     transplant patients.~   "
259217|NCT00156858|"~     A study of pharmacokinetics of daily intravenous busulfan~   "
259218|NCT00156845|"~     This study was designed to evaluate the ability of AI-700-enhanced rest-stress~     echocardiography to detect coronary artery disease (CAD) in patients with suspected ischemic~     heart disease who are indicated for coronary angiography.~   "
259219|NCT00156819|"~     This research study will compare the treatment effects of three different asthma medications~     in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled~     corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a~     combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone,~     montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are~     all approved for the treatment of asthma. We are looking at whether the three treatments are~     equally effective for reducing the number and the severity of asthma attacks in subjects with~     mild to moderately severe asthma.~   "
259220|NCT00156806|"~     Breast cancer treatment often involved radiation to the breast. A side-effect of this~     treatment is skin redness, itching and burning. Some patients have quite severe reactions.~     Our current treatment for this is to avoid any soaps or other skin irritants and to use a~     moisturizing cream once all radiation is finished. Aloe vera is believed by many people to be~     useful for treatment of skin burns but this has never been proven in a randomized study. The~     aim of this study is to compare aloe vera gel versus plan gel versus the standard treatment~     to determine if there is any benefit. If there was a benefit of gel treatment over standard~     it could make radiation treatments more tolerable for cancer patients.~   "
259221|NCT00156793|"~     This study was designed to evaluate the ability of AI-700-enhanced rest-stress~     echocardiography to detect coronary artery disease (CAD) in patients with suspected ischemic~     heart disease who are indicated for single-photon emission computed tomography (SPECT)~     imaging.~   "
259222|NCT00156780|"~     This study was conducted to evaluate the safety and pharmacokinetics of an echocardiographic~     contrast agent, AI-700, in patients with moderate to severe chronic obstructive pulmonary~     disease (COPD) and/or congestive heart failure (CHF).~   "
259237|NCT00156572|"~     Hydrochlorothiazide and spironolactone are diuretics that are commonly in preterm infants~     with bronchopulmonary dysplasia (BPD). Hyponatremia (low blood salt) is a common side effect.~     It is uncertain whether the best way to treat the hyponatremia is by oral salt~     supplementation or restricting fluid intake. Our hypothesis is that fluid restricted infants~     will be better able to preserve the beneficial effects of diuretics on the lungs. The study~     will include very low birth weight infants (VLBW) 400-1500g from Hermann Memorial Children's~     Hospital NICU or LBJ General Hospital NICU with BPD. They will be enrolled and randomly~     assigned to either the salt supplementation group or the fluid restriction group once they~     become hyponatremic (defined as serum Na <130). The study intervention will take place for~     four weeks. The primary outcome will be assessed by comparing the patient's initial oxygen~     and breathing machine requirements with those at the end of the four-week study period.~   "
260143|NCT00144612|"~     An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of~     MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP~   "
259223|NCT00156767|"~     An appropriate hypothalamic-pituitary-adrenal (HPA) axis response is required to survive~     critical illness. Primary adrenal insufficiency, relative adrenal insufficiency, tissue~     resistance to glucocorticoids, ACTH deficiency and immune-mediated inhibition of the HPA axis~     may impair the secretion or action of glucocorticoids in critically ill patients. Adrenal~     insufficiency is estimated to occur in up to 77% of critically ill patients, but currently,~     there is no consensus on the diagnostic criteria for adrenal insufficiency in this setting,~     and standard testing does not discriminate among the aforementioned factors. We will study~     the incidence and natural history of adrenal insufficiency in critically ill patients to~     further define adrenal insufficiency and provide data to develop diagnostic tests. Clinical~     features and outcomes will be correlated with laboratory measurements of hormones, cytokines~     and glucocorticoid action. Healthy volunteers will undergo cortrosyn tests with measurement~     of free cortisol levels to develop a normative range for this endpoint.~      <TAB>~      Previous glucocorticoid use, if prolonged and supraphysiologic, also inhibits the HPA and can~     result in adrenal insufficiency. Patients with short intermittent courses of glucocorticoid~     administration have not been studied well, and may also be at risk. To gain further~     information about this group, patients receiving pulse glucocorticoid doses as part of bone~     marrow transplant regimens at the Clinical Center will also be studied.~   "
259224|NCT00156741|"~     The purpose of this study is to provide evidence that the Refined Ventricular Pacing~     Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of~     ventricular pacing.~   "
259225|NCT00156728|"~     The purpose of the study is to characterize atrial arrhythmias in patients indicated for~     Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while~     CRT is provided.~   "
259226|NCT00156715|"~     The purpose of this study is to examine the efficacy of quetiapine (Seroquel) in reducing~     substance use in persons diagnosed with schizophrenia. The primary hypothesis is that~     quetiapine treatment will be associated with a decrease in substance use.~   "
259227|NCT00156702|"~     The primary hypothesis of this pilot study is that dependence can be prevented in adolescents~     who smoke, but who are not yet dependent. With this study, we seek to develop and test the~     feasibility and provide controlled comparisons of two brief smoking dependence-prevention~     interventions: motivational interviewing with feedback versus a video control. Forty~     adolescents between the ages of 12 and 18 will be enrolled. The evaluation and~     dependence-prevention phases will occur during a single 3- to 4-hour session, and the 30-45~     minute follow-up sessions will take place approximately one month, three months, six months,~     and one year after the completion of the evaluation and dependence prevention phases.~   "
259228|NCT00156689|"~     Considering the mechanisms of action which provide efficacy in epilepsy, it is hypothesized~     that treatment with levetiracetam will reduce the neuronal excitability involved in~     neuropathic pain associated with CIAP. Thus, there is a potential for levetiracetam to bring~     therapeutic benefit for the subjects because of its specific mechanism of action, its safety~     profile and the absence of interaction with other drugs.~   "
259229|NCT00156676|"~     The primary purpose of this study is to collect preliminary and pilot data to begin to~     determine whether the use of body weight support treadmill therapy (BWSTT) with and without~     driven-gait-orthotics (DGO), results in improved motor recovery and ambulation MS patients~     with gait impairment~   "
259230|NCT00156663|"~     The purpose of this study was to develop and evaluate an educational program intended to~     raise staff awareness about women veterans and their health care needs and preferences.~   "
259231|NCT00156650|"~     This study is being offered to all participants of the ACY-5 study as an optional addition to~     the male contraceptive study in which they participated. Participation is voluntary.~      The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount~     of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.~   "
259232|NCT00156637|"~     The goal of this project is to translate research findings about key aspects of antipsychotic~     treatment into routine care through a multi-component intervention, focusing on improving two~     aspects of medication management that are directly linked to patient outcomes: 1) monitoring~     for potentially serious metabolic side effects of newer antipsychotic medication, and 2)~     increasing the appropriate use of clozapine for treatment-refractory patients.~   "
259233|NCT00156624|"~     The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre~     study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and~     popliteal artery.~   "
259234|NCT00156611|"~     The Rio Study is a randomized, double blinded German- Swiss- Austria multi-centre trial on~     the efficacy and safety of ReoPro together with interventional recanalization of TASC D~     lesions in the SFA and popliteal artery.~   "
259235|NCT00156598|"~     Other research studies have shown that the levels of metals in the blood are slightly~     increased after patients receive a total hip replacement. We want to learn whether these~     elevated levels are associated with any adverse effects. We hope this study will help us~     identify which type of patients have elevated levels of metal in their blood.~   "
259236|NCT00156585|"~     Hypothesis: the pattern of MRI contrast enhancement after gadolinium injection is different~     in tumors that respond well to gamma knife.~      We are going to acquire sequential T1-weighted images of brain lesions before, during and~     after injection of Gd-DTPA. This will be repeated before and after a treatment with gamma~     knife. We will then analyse our results to see if there are common enhancement~     characteristics between lesions that will respond well to the radiosurgery treatment.~     Response will be clinically assessed by tumor volume as determined by MRI approximately 4 to~     6 months after treatment.~   "
259238|NCT00156559|"~     This research is designed to address the question, Does the relative deficit in vaccine~     immunogenicity in extremely premature infants persist beyond the first 6 months of life? We~     propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in~     relatively healthy, 12-to-15 month-old children born at <29 weeks gestation, when compared to~     full-term infants, as measured by the relevant viral serologies.~   "
259239|NCT00156546|"~     Our hypothesis is that long-term antimicrobial prophylaxis does not reduce the recurrence of~     infection and the risk of appearance of kidney scars in children with a documented previous~     upper UTI.~   "
260144|NCT00144599|"~     This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in~     patients with sJIA.~   "
259241|NCT00156520|"~     It is known that patients with aortic stenosis, including those undergoing cardiac surgery~     for this problem, are prone to developing bleeding problems, particularly of the~     gastrointestinal tract. It is believed that the shear stress associated with blood flow~     through the abnormal aortic valve results in abnormal hemostasis. Abnormalities include~     increased proteolysis of the von Willebrand factor (vWF) and increased binding of the high~     molecular weight multimers of vWF to platelet membranes with subsequent inappropriate~     platelet aggregation. Thus, appropriate aggregation of circulating platelets is impaired.~     Cardiac surgery is associated with significant alterations in hemostasis. Patients undergoing~     cardiac surgery consume a significant percent of available blood products throughout the~     United States and are subjected to various and numerous risks associated with blood product~     transfusion. In addition, excessive postoperative bleeding is a common cause for the need to~     surgically re-explore the chest cavity in patients who have just undergone cardiac surgical~     procedures. Such additional surgery carries further cost and risk. Following surgical~     correction of aortic valve stenotic pathology, associated vWF abnormalities appear to~     reverse. However, this process can take several days. Although all cardiac surgical patients~     are at risk for postoperative bleeding, patients undergoing aortic valve surgery for aortic~     stenosis may be particularly at risk for this postoperative complication. In addition,~     patients with aortic valve stenosis who undergo noncardiac surgery may have a predisposition~     to bleeding because of similar underlying shear stress induced abnormal vWF and platelet~     function. The proposed study is a trial to evaluate the effectiveness of 2 different~     antifibrinolytic drugs in ameliorating the hemostatic defect associated with aortic stenosis.~     Aprotonin, an antifibrinolytic agent which also has platelet preserving actions4, will be~     compared to the currently used anti-fibrinolytic, epsilon aminocaproic acid (EACA).~   "
259242|NCT00156507|"~     Children born less than 1500 grams are being enrolled into a study to test the effectiveness~     of a parental educational intervention in reducing the risk of future breathing problems. The~     intervention teaches parents of these children how to reduce the risk of / and recognize~     breathing problems.~   "
259243|NCT00156494|"~     This study involves telephone surveys of parents of young urban children with and without~     asthma to assess attitudes about smoking including personal smoking bans in their homes and~     cars, and beliefs about public policies regarding smoking.~   "
259244|NCT00156481|"~     This study involves in-depth interviews with parents of urban children with asthma and focus~     groups with additional parents in order to understand their attitudes and beliefs about~     smoking.~   "
259245|NCT00156468|"~     In prior work, we found that even children who have been seen by their physicians within the~     prior six months were frequently misclassified as having mild rather than persistent asthma.~     This study evaluations whether systematic office-based screening assists primary care~     physicians in identifying children with significant asthma and improves preventive care for~     asthma. We hypothesize that standardized screening in the office setting will improve the~     physician's ability to (a) identify children with significant asthma and (b) prescribe~     appropriate preventive medications.~   "
259246|NCT00156455|"~     This is an exploratory study designed to evaluate the incidence of, and to quantify sleep~     disordered breathing following stage I Norwood reconstructive surgery. Sleep disordered~     breathing will be correlated with:~        1. Elevations in pulmonary vasculature resistance at the time of Stage II surgery.~        2. Risks of death~   "
259247|NCT00156442|"~     The study is to examine the relationship between sleep apnea and neurocognitive behaviors in~     children with cleft lip/palate. Describe the incidence and severity of obstructive sleep~     apnea in an unselected population of grade school aged children with surgically repaired~     cleft palate.~      A. Is the incidence of OSA higher in children with cleft palate than age matched historical~     control groups? B. Are nighttime symptoms an adequate screening tool to exclude the diagnosis~     of OSA in children with surgically repaired cleft palate? Describe the velopharyngeal closure~     patterns during speech in an unselected population of grade school aged children with~     surgically repaired cleft palate. Describe the neurobehavioral phenotype of an unselected~     population of grade school aged children with surgically repaired cleft palate.~   "
259248|NCT00156429|"~     This is a retrospective review of the data available on patients and their family members~     with HCM and prospective follow-up of this cohort for clinical outcome and diagnostic~     studies. Genetic samples are being examined in this cohort to determine whether certain to~     determine whether certain beta-AR polymorphisms as well as other common genetic polymorphisms~     are associated with different morphological features, such as LVH in patients with HCM and~     whether these polymorphisms influence the clinical course and outcome in patients with HCM.~     For that purpose, we will build a database with clinical information including serial~     echocardiographic measurements for patients with HCM that have regular follow up and test~     them for beta-AR polymorphisms as well as other common genetic polymorphisms and other known~     cardiac-related polymorphisms that can potentially contribute to the morphologic differences~     seen in patients with HCM.~   "
259249|NCT00156416|"~     One of the consequences of breast cancer treatment for younger women is the abrupt onset of~     menopause and its related symptoms. Menopausal symptoms disrupt usual activities, alter sleep~     patterns and decrease quality of life. The purpose of this randomized feasibility pilot study~     is to examine mindfulness meditation for menopausal symptom management for women who are~     breast cancer survivors and for women with naturally occurring menopause. The study is~     designed to: 1. establish the feasibility of a mindfulness meditation program for women who~     experience menopausal symptoms (e.g. hot flushes). 2. explore the treatment benefit of a~     mindfulness meditation program for menopausal symptom relief using changes in frequency and~     severity of hot flushes; frequency of sleep disruption, various aspects of quality of life~     and physiologic stress response (cortisol) as outcome measures. 3. evaluate whether the~     treatment benefits of mindfulness meditation differ in menopausal women with naturally~     occurring menopause versus women with menopause secondary to chemotherapy for breast cancer.~     Participants randomized to the attention control group will be offered meditation training~     after completion of the intervention and follow up phases. Participants will attend 8~     meditation sessions or 8 attention control sessions. Study variables are Menopausal Hot~     Flushes (self report & skin conductance monitoring), Sleep Disruption (Pgh Sleep Quality~     Index), Physiologic Stress Response (cortisol), Quality of Life (Menopausal Quality of Life);~     and Protocol Design (recruitment & retention rates, exit interviews). A convenience sample of~     60 women who experience menopausal symptoms will be recruited.~   "
259250|NCT00156403|"~     This pilot study is a feasibility, safety, and preliminary benefits study to look at whether~     giving the calcium channel blocker amlodipine to people with hereditary pancreatitis as a~     prophylactic measure can reduce the inflammatory process in the pancreas.~   "
259424|NCT00154115|"~     Prospective, randomized, double blind study investigating the efficacy of levosimendan in~     heart failure after cardiac surgery.~      Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and~     morbidity and may improve survival after heart valve surgery.~   "
259251|NCT00156390|"~     Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million~     individuals. It is estimated that in the next year nearly 400,000 new cases will be~     diagnosed, 1 million individuals will be hospitalized and 300,000 deaths will occur because~     of HF. Approximately half of the deaths will be attributed to worsening pump function while~     the remainder will be attributable to sudden cardiac death.~      Biventricular (BIV) pacing has recently emerged as an exciting new treatment of advanced HF~     with dramatic benefits to some patients. Current candidates include those with ventricular~     conduction abnormalities and reduced ejection fraction who continue to suffer from severe HF~     symptoms despite optimal pharmacological therapy. Recent clinical trials have demonstrated~     that BIV pacing improves myocardial function, functional capacity, quality of life, as well~     as reduces the incidence of hospitalization and even prolongs life. Despite all this, about~     one third of patients with HF do not benefit from BIV pacing, the so-called 'non-responders'.~     Our group and others have shown that there are direct genetic effects of BiV pacing in an~     animal model, however, there are gaps in existing knowledge about the effects of left~     ventricular (LV) pacing site or genetic influences on the degree of response to this novel~     therapy.~      This proposal aims at identifying predictors of benefit from Biventricular (BIV) pacing with~     the goal of optimizing the degree of benefit and increasing the proportion of patients who~     respond to this therapy. Patients who fulfill current indications for BIV pacing will undergo~     and echocardiography (echo) with regional tissue Doppler analysis and cardiac imaging~     consisting of a myocardial perfusion imaging(EGC rest gated Spect scan using Sestamibi) prior~     to implantation of a BIV pacing device. They will then be randomly assigned to empiric versus~     echo and Spect scan-guided LV lead positioning. In this latter group, optimal LV pacing site~     will be defined as the site of latest peak tissue velocity by tissue Doppler echo and Spect~     scan testing. In the empiric group, the LV lead position will be chosen by the masked~     operator based on the coronary sinus venous anatomy, on electrocardiographic (ECG) criteria,~     or other as per standard of care. Blood would be collected from all patients at the time of~     the procedure for analysis of genetic polymorphisms.~   "
259252|NCT00156377|"~     In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on~     subsequent Staphylococcus aureus infection, a prospective randomized trial was performed~     particularly including patients with predisposing risk factors for S. aureus infections.~   "
259253|NCT00156364|"~     A. To study the effects of pancreas transplantation (PT) on the structural abnormalities of~     diabetic nephropathy (DN) in patients with type 1 (insulin-dependent) diabetes mellitus (type~     1 D). These studies will address the influence of long-term normoglycemia on two stages of~     diabetic renal disease.~      Due to the difficulties encountered for recruitment of patients to agree to undergo a GFR and~     a native kidney biopsy in conjunction with their clinical evaluation visit for transplant, we~     are now focusing efforts on obtaining skin biopsies previous to transplant, and then at~     regular intervals (3, 6, and 9 months, and yearly) following a successful transplantation.~        -  Pancreas Transplantation Alone (PTA). To determine, at 5, 10, and 15 years after PTA,~          the effects of normoglycemia on the established lesions of DN in the long-term type 1 D~          patients' own kidneys.~        -  Islet Transplantation Alone (ITA). To determine, at 5 years after ITA, the effects of~          normoglycemia on the early lesions of DN in type 1 D patients' own kidneys.~        -  Pancreas Transplantation after Kidney Transplantation (PAK). To determine at 5-10 years~          the effects of normoglycemia on the early structural lesions of DN in kidneys~          transplanted some years earlier into type 1 D recipients.~      Hypothesis: The benefits of PT on the early glomerular lesions of DN will be demonstrable~     after 5 years in kidneys exposed to diabetes for a short duration, while in patients with~     long-standing type 1 D and more advanced glomerular DN lesions, longer exposure to euglycemia~     is necessary to demonstrate arrest or regression of the lesions.~   "
259254|NCT00156351|"~     The overall purpose of this project is to conduct an innovative, culturally-tailored~     demonstration project designed to facilitate the adoption and maintenance of regular,~     moderate physical activity (i.e., brisk walking) in a sample of sedentary African American~     women. In addition, we will test the impact of varying types of counseling and social support~     on the adoption and maintenance of regular physical activity and help women improve their~     weight control. The core behavioral change program will be based on a comprehensive wellness~     oriented website offered by the National Black Women's Health Project (NBWHP). Comparisons~     will be made between the effects of the web-based program with only minimal face to face~     contacts, primarily for enrollment, data collection, and participant retention, the web-based~     program with the addition of telephone counseling and support, and the web-based program with~     face to face group counseling and support.~      Hypotheses. Hypothesis 1. Participation in the intervention will result in increased physical~     activity levels, regardless of the level of social support.~      Hypothesis 2. The intervention arm involving the lowest level of social support will be~     marginally effective for increasing physical activity levels, and additional social support~     will result in significantly improved physical activity levels when compared with the lowest~     level of social support.~      The specific intervention questions are:~        1. How well do the interventions address the program objectives ((quality of~          implementation), to be determined through protocol review for operationalization of~          theoretical constructs)?~        2. Was the program implemented as planned ((fidelity to protocol and dose of intervention),~          to be determined from implementation process variables, including characteristics of~          women recruited, fidelity to protocols for contact with participants, and quality of~          counseling given, where applicable)?~        3. Did the program (separately for each format tested) have a significant effect on~          potential mediators of behavior change (influence on presumed intermediate outcomes)?~          For the purpose of this proposal, a mediator is defined as any barrier to or facilitator~          of physical activity participation (e.g., time, self efficacy, social support, access,~          perceived norms) as implied in the 12 behavioral objectives that have been specified.~        4. What is the optimum type of counseling and support to enhance the on-line activities in~          order to produce significant behavior change (importance of various program components)?~        5. Did the program (separately for each format tested) have a significant effect on the~          primary study outcomes (influence on primary behavioral outcome, e.g., physical activity~          by self-report of activity levels or pedometer counts)?~        6. Do changes in mediators explain changes in the primary outcomes (multivariate models to~          understand if presumed process of behavioral change was observed in practice)?~        7. Does the internet only program appear to result in increased physical activity~          participation when compared to extant data on trends among Black women in the U.S.~          population (what is accomplished with very minimal intervention and how does it compare~          with a more extensive program)?~   "
259255|NCT00156338|"~     The purpose of this study is to determine whether intraoperative fluid and sodium restriction~     decreases postoperative morbidity~   "
259256|NCT00156325|"~     This study will investigate the efficacy of Escitalopram, a Selective Serotonin Reuptake~     Inhibitor (SSRI) antidepressant, in the treatment of Bipolar II Disorder.~      The use of antidepressants for those with bipolar disorder appears common in clinical~     practice but is not countenanced - at least as monotherapy - in formal treatment guidelines.~     This view reflects concerns about the possibility of antidepressant drugs inducing switching~     and rapid cycling in those with Bipolar Disorder. Although the effectiveness of treating~     Bipolar II patients with SSRIs has received very little attention in the literature,~     observations of Bipolar II patients treated with SSRIs suggest they may have general mood~     stabilising properties. Many patients have reported improvements not only in their depressed~     mood, but also a reduction in the severity, duration and frequency of hypomanic episodes.~      In this proof of concept study we specifically assess whether a standard dose of an SSRI~     antidepressant is more effective than placebo in reducing the frequency, severity and~     duration of both depressive and hypomanic episodes.~   "
259257|NCT00156312|"~     The purpose of this study is to determine whether the combination of the drugs docetaxel and~     capecitabine is effective in treating breast cancer patients.~   "
259258|NCT00156299|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in cancer cells. It may also help doctors~     understand how cancer cells respond to treatment with choline magnesium trisalicylate.~      PURPOSE: This pilot clinical trial is studying gene expression in cancer cells during~     chemotherapy and the safety of choline magnesium trisalicylate in treating patients with~     newly diagnosed acute myeloid leukemia.~   "
259259|NCT00156286|"~     This study involves being treated initially with a combination of drugs called irinotecan and~     cisplatin (induction therapy), followed by treatment with a drug called Gleevec (maintenance~     therapy). The main purpose of this study is to determine if this type of treatment will delay~     the growth of the tumor and if so, for how long. The investigators also want to find out how~     the tumor is affected solely by induction therapy with irinotecan and cisplatin, what~     side-effects occur when Gleevec maintenance therapy is used, and if this treatment (induction~     followed by maintenance therapy) will improve the duration of survival~   "
259260|NCT00156273|"~     We are trying to develop better ways to detect when cancer therapies are working.~   "
259261|NCT00156260|"~     The primary purpose of this research is to analyze the cells present in the fluid obtained~     via ductal lavage from the nipple of a woman with a known diagnosis of breast cancer. A~     portion of the lavage fluid may be used in future breast cancer biomarkers. Remaining lavage~     fluid will be used to analyze its biochemical composition, for investigational purposes only.~   "
259262|NCT00156247|"~     To determine whether acitretin plus etanercept is more effective than etanercept alone in~     clearing psoriasis plaques in adults.~   "
259263|NCT00156234|"~     Patients suffering from congestive heart failure report reduced exercise capacity. This~     skeletal muscle dysfunction is also detectable when using small muscle groups which should~     not put any demand on the heart.~      We hypothesize that congestive heart failure has systemic effects that causes the skeletal~     muscle dysfunction.~   "
259264|NCT00156221|"~     The specific is to study the MR morphologic and spectroscopic brain correlates and predictors~     of development in children with severe developmental disorders (autistic spectrum disorders~     and/or mental retardation and/or language disorders). Given the frequently observed~     association of autism with known medical conditions, particularly in cases with comorbid~     mental retardation and in cases with atypical autism (Rutter et al., 1994; Gillberg, 1995),~     children with suspected autism or related developmental disorders will be asked to~     participate in an extensive state of the art laboratory work-up which includes T1 and T2~     weighted MRI of the brain. MRI data will be analyzed both qualitatively, looking for focal~     abnormalities and degree of myelination, and quantitatively, measuring volumes of total~     brain, cerebellum, ventricles and grey and white matter. For research purposes, the work-up~     will be supplied with proton Magnetic Resonance Spectroscopy (MRS) of the brain. This data~     set provides the opportunity to chart brain-behavior relationships in young children with~     suspected autism and related PDD cross-sectionally.~   "
259265|NCT00156208|"~     The objective of this study is to determine the long-term safety of asoprisnil in women with~     symptomatic uterine fibroids who completed the 6 month Study C02-037.~   "
259266|NCT00156195|"~     The objective of this study is to determine the long-term safety of asoprisnil in women with~     abnormal uterine bleeding associated with uterine fibroids.~   "
259267|NCT00156182|"~     This study was designed to determine the long-term safety of asoprisnil 10 mg in women with~     one or more uterine fibroids after an initial 12 weeks in study M99-144.~   "
259268|NCT00156169|"~     The effect of fibrates on high density lipoprotein (HDL)-cholesterol levels is suggested to~     be mediated by its binding to peroxisome proliferator-activated receptor-g (PPARg). Upon~     ligand binding, PPARg heterodimerizes with the 9-cis retinoic acid receptor (RXR), and the~     heterodimer regulates gene expression. We assessed the hypothesis that a dual treatment with~     fibrate plus 9-cis b-carotene-rich powder of the alga Dunaliella bardawil, as a source of~     9-cis retinoic acid, would improve the drug's effect on HDL-cholesterol levels.~      patients with plasma HDL-cholesterol levels below 40 mg/dl and triglyceride (TG) levels above~     200 mg/dl after fibrate treatment (for at least 6 weeks). are given four capsules of~     Dunaliella, providing 60 mg b-carotene/day. The all-trans to 9-cis b-carotene ratio in the~     capsules is about 1:1.~   "
259269|NCT00156156|"~     The objective of this study is to determine the long-term safety of asoprisnil in women with~     abnormal uterine bleeding associated with uterine fibroids.~   "
259270|NCT00156143|"~     To evaluate in boys and girls the improvement in body composition under GH treatment in~     adolescents with CO-GHD who remain partially GHD after GH discontinuation.~   "
259271|NCT00156130|"~     This study is evaluating the long-term outcomes of women in a randomized trial that compared~     accelerated whole breast irradiation (42.5 Gy in 16 fractions over 22 days) to a longer~     conventional schedule of whole breast irradiation (50 Gy in 25 fractions over 35 days)~     following breast-conserving surgery. The outcomes evaluated will include cosmetic outcome and~     cardiac disease as a measure of late radiation morbidity and local breast recurrence as a~     measure of effectiveness.~   "
259272|NCT00156117|"~     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by~     Positive symptoms (symptoms that should not be there, inability to think clearly, to~     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or~     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and~     relate to others). Other symptoms include reduced ability to recall and learn new~     information, difficulty with problem solving, or maintaining productive employment. The~     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily~     dopamine and serotonin, which enables brain cells to communicate with each other.~      Asenapine is an investigational drug that may help to correct the imbalance in dopamine and~     serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a~     comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that~     complete this trial will have the option of continuing in an additional one year extension~     trial.~   "
259344|NCT00155168|"~     In this project, we will establish the efficient and accurate gene dose determination system~     by combining the heterodulex analysis and gene dose analysis on DHPLC platform based on~     various quantitative and multiplex PCR strategies and applying on detecting the carriers- in-~     risk and patients with spinal muscular atrophy.This method is, therefore, based on the~     observation that the amount of PCR product generated from each site of amplification is~     proportional to the amount of starting template. Detection of PCR products is carried out on~     DHPLC, which provide the sensitivity required for the detection of the single-copy dosage~     changes.~   "
259441|NCT00153894|"~     The purpose of this study is to determine whether an exercise program comprised of strength~     and endurance training will lower fasting insulin levels in a group of breast cancer~     survivors. Insulin may be involved in the risk of breast cancer recurrence.~   "
259273|NCT00156104|"~     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by~     Positive symptoms (symptoms that should not be there, inability to think clearly, to~     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or~     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and~     relate to others). Other symptoms include reduced ability to recall and learn new~     information, difficulty with problem solving, or maintaining productive employment. The~     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily~     dopamine and serotonin, which enables brain cells to communicate with each other.~      Asenapine is an investigational drug that may help to correct the inbalance in dopamine and~     serotonin. This is a 6-week trial to test the efficacy and safety of asenapine, compared with~     placebo, using an active comparator agent (haloperidol) in the treatment of patients with an~     acute exacerbation of schizophrenia. Patients who complete the 6-week trial will have the~     option of continuing in an additional one year extension trial.~   "
259274|NCT00156091|"~     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by~     Positive symptoms (symptoms that should not be there, inability to think clearly, to~     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or~     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and~     relate to others). Other symptoms include reduced ability to recall and learn new~     information, difficulty with problem solving, or maintaining productive employment. The~     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily~     dopamine and serotonin, which enables brain cells to communicate with each other.~      The clinical development of asenapine, as described in the 2007 IDB appears to have~     antipsychotic activity with superior symptomatic control compared to placebo and an improved~     safety profile compared to currently available neuroleptics. Its fast dissolving formulation~     may further add to treatment compliance. While various titration schedules have been used in~     previous studies, dose increases at 5 mg BID up to 10 mg BID have been well tolerated.~     Therefore, further exploration in a larger group of subjects with acute exacerbation of~     schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual~     clinical practice in a long-term 52-week extension trial.~   "
259275|NCT00156078|"~     A study of pregabalin efficacy and safety in a racially and culturally diverse group of~     subjects with painful diabetic peripheral neuropathy (DPN).~   "
259276|NCT00156065|"~     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by~     Positive symptoms (symptoms that should not be there, inability to think clearly, to~     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or~     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and~     relate to others). Other symptoms include reduced ability to recall and learn new~     information, difficulty with problem solving, or maintaining productive employment. The~     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily~     dopamine and serotonin, which enables brain cells to communicate with each other.~      The clinical development of asenapine, as described in the 2007 IDB appears to have~     antipsychotic activity with superior symptomatic control compared to placebo and an improved~     safety profile compared to currently available neuroleptics. Its fast dissolving formulation~     may further add to treatment compliance. While various titration schedules have been used in~     previous studies, dose increases at 5 mg BID (twice daily) up to 10 mg BID have been well~     tolerated. Therefore, further exploration in a larger group of subjects with acute~     exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID)~     will mimic actual clinical practice in a long-term 52-week extension trial.~   "
259277|NCT00156052|"~     To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions~     over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25~     fractions over 35 days) in women with node negative breast cancer who have undergone~     lumpectomy.~      The primary outcome is local breast recurrence and secondary outcomes include morbidity and~     cost effectiveness.~   "
259278|NCT00156039|"~     The purpose of this study is to determine whether family physician 'routine follow-up care'~     of women with breast cancer in remission is an acceptable alternative to the existing system~     of specialist follow-up. Primary outcome measure are event rates of oncological catastrophes~     and quality of life.~   "
259279|NCT00156026|"~     This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month~     follow-up with colposcopy and treatment if CIN 1 progresses.~   "
259280|NCT00156013|"~     This research is being done to develop new treatment for non-hodgkin's lymphoma in subjects~     whose cancer has returned or resisted treatment with chemotherapy. The investigational drug~     clofarabine is being used in this study. An investigational drug is one that has not been~     approved by the United States Food and Drug Administration (FDA).~   "
259281|NCT00156000|"~     Among women with a twin pregnancy, currently enrolled in a study in which they are receiving~     weekly injections of 17-alpha-hydroxyprogesterone caproate verses placebo injections, fetal~     fibronectin (fFN) and salivary estriol (E3 ) will identify the following.~        1. Women at increased risk for preterm delivery.~        2. A subpopulation, among those receiving the active drug, who may respond to progesterone.~      If fFN and/or E3 identify a population of patients who respond to progesterone, these~     diagnostic tests may define women who may or may not be good candidates for progesterone~     therapy.~   "
259282|NCT00155987|"~     This is a multi-centre randomised trial to evaluate the effect of early decompressive~     craniectomy on neurological function in patients with severe traumatic brain injury.~      The primary outcome is neurological function measured at 6 months post injury using the~     Glasgow Outcome Score. Neurological function is qualified as proportion of favourable~     outcomes (Glasgow Outcome Score Extended [GOSE] grades 5-8).~   "
259368|NCT00154843|"~     Primary: To determine factors that affect absorption and serum levels of lycopene after~     supplementation.~      Secondary:~        1. To evaluate general safety and tolerability of oral lycopene 15 or 30 mg per day for 12~          weeks.~        2. To determine lycopene effects on reducing serum levels of prostate specific antigen~          (PSA) and on relieving lower urinary tract symptoms (LUTS) in relation to prostate~          hypertrophy as evaluated by the International Prostate Symptom Score (I-PSS).~   "
259464|NCT00153595|"~     The aim of this double-blind, randomized, parallel group, placebo-controlled study is to~     assess the efficacy and safety of EWO1 in patients with moderate to severe perennial allergic~     rhinitis (AR).~   "
259283|NCT00155974|"~     The purpose of this study is to develop and determine the effectiveness of a multi-level~     community participatory intervention designed to rapidly immunize hard-to-reach populations,~     including substance users, within disadvantaged minority communities.~      Specific Aims of the project are as follows:~        1. To identify the relative contributions of personal factors and structural barriers to~          immunization status in hard-to-reach populations.~        2. To estimate the size of the hard-to-reach population in specified disadvantaged urban~          communities using venue-based sampling, probability-based sampling, capture-recapture~          methods and modified Delphi techniques.~        3. To compare vaccination rates in hard-to-reach populations between neighborhoods that~          receive a community-based vaccine outreach intervention versus neighborhoods where~          vaccines are offered through standard public health programs, using an incremental~          crossover multilevel community intervention design.~   "
259284|NCT00155961|"~     Introduction~      Male ageing is associated with sarcopenia, frailty, osteopenia, obesity, the metabolic~     syndrome and cardiovascular disease. To what extent the androgens affect these signs of~     ageing is still largely undetermined. A few studies have shown divergent results concerning~     the relation between ageing and serum levels of testosterone. It still remains to be shown~     whether there is a pure age-related decline in serum testosterone or whether other factors~     such as obesity, chronic illness or medication are responsible for the lower serum~     testosterone found in elderly men when compared with young men. To investigate these issues a~     cohort of 600 men aged 60 to 75 years is examined.~      Objective~      The aim of the study is to investigate the relation of testosterone (T) to body composition~     (BC) and physical performance (PP). Measures for BC are muscle mass (MM), bone mineral~     density (BMD) and fat mass (FM). Parameters for PP are maximum voluntary force (MVF), maximum~     oxygen uptake (VO2max) and muscle power (P). We hypothesize that T is positively associated~     with MM, BMD and all PP parameters, but negatively associated with FM. We will furthermore~     examine whether life style, medication, chronic disease, hormones and binding proteins exert~     their actions on BC and PP solely through or independently of T. The levels of s-total and~     free T in this cohort will be compared with the s-total and free T levels from a cohort of~     young men aged 20 to 30 years. Furthermore the associations found between T and BC and PP in~     the two cohorts will be compared to investigate whether T plays the same role in the two~     groups.~   "
259285|NCT00155948|"~     The purpose of this study is to investigate the validity and reliability of measurement for~     cervical multifidus using ultrasonography, and to investigate cervical multifidus muscle~     function by the change pattern of multifidus thickness, and to compare the changes in muscle~     thickness among different resistance levels (rest, 25%, 50%, 75% and 100%) and different~     cervical levels (C4, C5 and C6).~   "
259286|NCT00155935|"~     Ovarian cancer has the highest mortality rate of gynecologic malignancies and the overall~     5-year survival rate of ovarian cancer is only 20-30%. Additionally, the incidence of ovarian~     cancer has increased in recent years in Taiwan. Ovarian cancer is indeed a disease that~     should be respected, however, there was very little research work focusing on it in Taiwan.~     Patients with ovarian cancer who have stage I disease (localized to ovaries) after optimal~     surgical staging do not need any adjuvant therapy. In contrast, patients with cancer~     spreading beyond the ovaries have median survival rates that decrease to less than (<) 10%~     for patients with bulky residual disease after surgery and treatment with platinum-based~     combination chemotherapy. In developing effective therapy for ovarian cancer, there should be~     a distinction between preventative and therapeutic approaches. Immunoprevention will be~     developed for women who are at an increased risk for the development of ovarian cancer. In~     contrast, immunotherapy would be used as an adjuvant to surgery or in combination with~     chemotherapy or other biologics such as chemoimmunotherapy or biochemoimmunotherapy. The~     folate receptor (FR) is expressed in some normal epithelial cells and is elevated in certain~     carcinomas. The FR has been reported to be selectively overexpressed in 90% of non-mucinous~     ovarian carcinomas. The specific epitopes of the folate receptor in the HLA-A2 haplotype have~     been identified. It appears that the folate receptor could be a target antigen for the~     immunotherapy of ovarian cancer.~      Therefore the investigators would like to propose the development of folate receptor-specific~     immunologic assays. There are two aims in this project:~        1. to develop and utilize assays to measure cytotoxic T-lymphocytes (CTLs) to folate~          receptors, and~        2. to evaluate the folate receptor-specific immunologic responses between normal controls~          and ovarian cancer patients.~   "
259287|NCT00155922|"~     The investigators hypothesize that macrophages play a crucial role in the pathogenesis of~     atherosclerosis in patients with type 2 diabetes mellitus (T2DM).~   "
259288|NCT00155909|"~     A prospective observational study to evaluate clinical, dosimetrical, functional, and~     biological factors in predicting radiation pneumonitis.~   "
259289|NCT00155896|"~     Ovarian cancer is the first mortality rate of gynecologic malignancies. The incidence of~     ovarian cancer increased in recent 10 years. Ovarian cancer indeed is a disease that should~     be respected, however, there were only few of research work focusing on it in Taiwan.~      To study the mechanisms of carcinogenesis of ovarian cancer will help us understand this~     disease and develop new strategies of diagnosis and prevention for ovarian cancer in the~     future. The present diagnostic methods of malignancy are clinical symptoms, physical~     examination, evaluation of tumor markers and instruments. It is a important issue to diagnose~     cancer earlier to improve the survival of cancer patients. By the development of biomedical~     science, many genes have been identified to be related with the carcinogenesis. If we can~     detect the possibility of genetic mutation earlier, we may deal with the suspected areas of~     malignancy as soon as possible. To our present knowledge, carcinogenesis of ovarian cancer~     has strong correlation with some special genes such as BRCA1 and BRCA2 genes. There is 1 out~     of 200 normal population with BRCA1 or BRCA2 gene mutation in the western countries. The~     incidences of BRCA1 or BRCA2 gene mutation even increase to 30-50% in the population of~     familial ovarian cancer. Women with BRCA1 gene mutation have 80% to get breast cancer before~     the age of 70 and 63% of them would get ovarian cancer before the age of 70. Women with BRCA2~     gene mutation have 80% to get breast or ovarian cancer before the age of 70. It seems that~     the genetic diagnosis of BRCA1/BRCA2 has its clinical practice. The development of new~     instrument- denaturing high-performance liquid chromatography (DHPLC) is to use automated~     detection to find out the minute or single mutation of nucleotide. It has been applied to the~     clinical service by utilizing DHPLC for the genetic diagnosis of BRCA1 and BRCA2 of breast~     cancer patients in the department of Genetic Medicine of our hospital. It will become a most~     powerful tool to establish the database of BRCA1 or BRCA2 gene mutation of the ovarian cancer~     patients in Taiwan, when we can use the technique of DHPLC combining with the direct DNA~     sequencing.~   "
259290|NCT00155883|"~     The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus~     24-hour infusion of high-dose 5-FU/leucovorin chemotherapy for patients with inoperable~     advanced gastric cancer.~   "
259366|NCT00154869|"~     The investigators' pilot study indicates that hepatitis C virus (HCV)- and hepatitis B virus~     (HBV)-coinfected patients with predominantly active hepatitis C and those with predominantly~     active hepatitis B may need different anti-viral regimens. Since in the majority of these~     coinfected patients the hepatitis activity is more likely due to HCV than to HBV, the optimal~     therapeutic regimen for HCV- and HBV-coinfected patients with predominantly active hepatitis~     C will first be investigated. The combination therapy using pegylated interferons (IFNs) such~     as PEG-IFN alfa-2a has been shown to have a superior efficacy than that using conventional~     IFN in the treatment of monoinfected chronic hepatitis C. This new combination therapy might~     also further enhance the treatment efficacy in HCV- and HBV- coinfected patients. The~     investigators therefore propose to initiate a trial comparing the efficacy of pegylated IFN~     plus ribavirin (RBV) in dual chronic hepatitis B and C versus that in chronic hepatitis C~     only, for both HCV genotype 1 and 2/3 patients. The efficacy using a 24-week combination~     therapy in the sustained clearance of serum HCV RNA is equivalent to that using a 48-week~     combination therapy in patients with HCV genotype non-1 [Hadziyannis et al, EASL 2002]. A~     48-week course of pegylated IFN and RBV combination therapy, in contrast, has been shown to~     yield a better efficacy in the sustained clearance of serum HCV RNA in patients with HCV~     genotype 1 than a 24-week combination therapy in western countries [Hadziyannis et al, EASL~     2002; Poynard et al, 1998]. The primary objective of the current proposal is to investigate~     and compare the efficacy of combination therapy using pegylated IFN plus RBV on the clearance~     of serum HCV RNA in both dually infected patients with a dominant HCV infection and HCV~     monoinfected patients. Therefore, in this proposal, the treatment duration will be 24 weeks~     for HCV genotype 2/3 in patients with dual chronic hepatitis C and B and in patients with~     monoinfected HCV, and will be 48 weeks for HCV genotype 1 in patients with dual chronic~     hepatitis C and B and in patients with monoinfected HCV.~   "
259291|NCT00155870|"~     Laparoscopic assisted vaginal hysterectomy (LAVH)has become the most prevalent operation~     method in woman suffering from uterine myoma or adenomyosis nowadays. The operation decisions~     for these women are always due to symptoms such as pain, anemia and mass effect. However,~     there is a lack of measurement for these symptoms and therefore highlight the need to~     validate these symptom by health-related quality of life (QOL) assessments. Patients usually~     recovered better by LAVH comparing to traditional open surgeries. However, LAVH was~     restricted to cases with small size uteri and most QOL reported neglected uterine weight or~     were based on small uteri size. We recently intervened a new surgical procedure called RULU~     during LAVH and thus released this limitation. This will give a more unbiased study on the~     effect of QOL in patients receiving LAVH. In this study, we plan to use two questionnaires:~     the disease specific UFS-QOL and the WHO-QOL Taiwan version questionnaires for patients~     receiving LAVH. Assessment will be performed before operation; and 3 days, 7 days, 3 months~     and 18 months after operation. From these assessments, we plan to determine which QOL~     variables will be useful as operation guidelines for patients suffering from leiomyoma or~     adenomyosis, and for the assessment of appropriates and outcomes of LAVH.~   "
259292|NCT00155857|"~     The purpose of this study is to evaluate the possible candidate gene of Primary Angle-Closure~     Glaucoma.~   "
259293|NCT00155844|"~     Bone marrow consists of a complex hematopoietic cellular component.When the blood progenitor~     cells differentiate to mature cells, they will exit unassisted to peripheral blood. On the~     other hand, the immature cells trapped by marrow-blood barrier. However, malignant~     transformation of the hematopoietic progenitor cells in AML and CML results in a blockade of~     their ability to terminally differentiate, causing a rapid accumulation of immature~     cells.Chemokines have been shown to direct the movement of cells between intravascular and~     extravascular compartments.The CXC chemokine CXCL12, the ligand of CXCR4, activates distinct~     signaling pathways that may mediate cell migration.In the preliminary research, we analyze~     the CXCR4 expression and the chemotactic response of CXCL12 and peripheral plasma in six~     leukemia cell lines (HL-60, HL-CZ, K562, U937, Raji and Jurkat) and found that three~     categories among them could be suggested: one is CXCR4 (-) and CXCL12 response (-), such as~     HL-CZ and K562 cells; the other is CXCR4 (+) and CXCL12 response (-), such as HL-60 and Raji~     cells; the rest is CXCR4 (+) and CXCL12 response (+), such as Jurkat and U937 cells. These~     results make us wonder that the leukemic cells could egress to PB from BM is due to~     destruction of homing process or the activation of mobilization process through CXCR4-CXCL12~     axis dysfunction. Therefore,we will focus on evaluating the mechanism of CXCR4-CXCL12 axis~     dysfunction in the various leukemic cell lines and primary leukemic cells.~   "
259294|NCT00155831|"~     Current approaches to treatment of premature infants at risk for neurodevelopmental~     disabilities have emphasized early assessment and intervention within the first year of life~     to optimize their developmental outcome. However, the information concerning the course of~     early neuromotor development and the factors contributing to neurodevelopmental disabilities~     in premature infants with CLD is limited. Therefore, the major purposes of this three-year~     multi-centered developmental follow-up study are threefold. (1) We will prospectively~     evaluate the early neuromotor performance of premature infants with CLD and premature infants~     without CLD from birth until 12 months of corrected age. (2) We will follow up the~     neurodevelopmental outcome of these infants at 12,18 and 24 months of corrected age to~     identify the early neuromotor impairments that predict later neurodevelopmental disabilities.~     (3) We will examine two potential influencing factors i.e., respiratory disease itself and~     brain lesions that may contribute to the neurodevelopmental disabilities in premature infants~     with CLD.~   "
259295|NCT00155818|"~     Several chromosomal loci obtained from genetic linkage studies have been reported of relating~     to schizophrenia. These areas include of 1q32-41, 6p24-21, 8p22-21, 15q13-14, and 22q11-12.~     The names of these genes located in these loci have not been identified, nor have the~     function and the relationship to the disease. Our research team using genetic linkage studies~     has found a strong linkage (NPL Z score = 2.18, p=0.01) between the D1S251 marker and~     schizophrenia disease. This marker is about 4 kb away from DISC1 (disrupted in schizophrenia~     gene 1) gene. In a Scottish family, a balanced translocation [t(1;11) (q42.1;q14.3)] has~     cosegregated inside the schizophrenia affected members of the family (LOD score =6.0). The~     breakpoint of the translocation is located at the intron area between exon 8 and exon 9 of~     DISC1 gene. This translocation disrupted the gene and caused its malfunction. A large~     molecular genetic study study recently in Finland has also demonstrated strong linkage~     evidence (Zmax=3.21) between the DIS2709 marker, located among exon 4 and exon 5 of DISC1~     gene, and schizophrenia in a. All these findings have indicated that DISC1 gene is a~     potential positional candidate gene and worth for further study.~      The main purposes of this proposal include: (1) To evaluate the incidence rate of the~     balanced translocation between the chromosome 1q42.1 and 11q14.3 in approximately 500~     schizophrenic patients in Taiwan. Furthermore, we will compare the clinical symptoms, illness~     course, and family genetic model to examine if any particular characters coexist with the~     translocation. (2) To search for the genetic polymorphisms in DISC1 gene area, where the~     thirteen exons, the promoter regions (1 kb upstream the start codon), and the breakpoint area~     (1 kb of both upstream and downstream area) will be analyzed by the method of denaturing high~     performance liquid chromatography (DHPLC). Case-control association study will be performed~     further in each 200 schizophrenic patients and normal controls to evaluate the relationship~     between the disease and the clinical characteristics.~      This proposal is quite feasible and prospective with the following reasons. (1) All the DNA~     samples and the clinical data have been collected and evaluated completely for further~     analysis. (2) Our research team has built up an integrated andreliable molecular genetic~     laboratory. All the facilities necessary for this study (DHPLC) had been setup with standard~     operating protocols and working routinely. (3) DISC1 gene has strong linkage evidence with~     schizophrenia in Taiwanese sample. The high prior probability of DISC1 gene as a positional~     candidate gene increases the successfulness of association study. . (4) Once the relationship~     among balance translocation, genetic polymorphism and the schizophrenia have established,~     further functional study will be evaluated to understand the possible mechanisms involved in~     the disease.~   "
259301|NCT00155740|"~     Ovarian cancer became a more and more important disease in recent years due to its first~     mortality rate of gynecologic malignancies. The incidence of ovarian cancer also increased in~     recent year in Taiwan. The lack of symptoms, difficulties in early diagnosis, insufficient~     accurate tumor markers, and lack of information about ovarian tumor biology contribute to the~     poor prognosis in ovarian cancer patients. The prognostic parameters for ovarian carcinomas~     are tumor stage, histologic subtype, degree of malignancy, and residual tumor after surgical~     treatment. However, these factors present an incomplete picture of the tumor biology of~     ovarian cancer and are frequently interrelated. Thus, the identification of new biologic~     factors predictive of individual disease course and prognosis would be extremely useful.~      Detection of tumor markers that are released into the circulation can aid in the diagnosis~     and/or monitoring of therapeutic responses of patients with various tumors, including~     carcinomas of ovary. CA125 is the most commonly used serum marker for patients with ovarian~     carcinoma. Although it has proven clinically valuable in monitoring the response of patients~     to therapy, some ovarian carcinomas do not express CA125, and CA125 often is increased in~     patients with inflammatory disease. Thus, there is a need for improvement, either in the form~     of a more specific and/or sensitive assay or an assay that uses a different marker and can be~     used to complement CA125 toward the goal to improve patient survival by improving diagnosis.~      Mesothelin is a 40-kDa glycosylphosphatidylinositol-linked glycoprotein. In normal tissues,~     the expression of mesothelin has subsequently been shown to be largely restricted to~     mesothelial cells, although immunoreactivity has also been reported in epithelial cells of~     the trachea, tonsil, fallopian tube, and kidney. Mesothelin has been shown to be~     over-expressed in pancreatic carcinomas, gastric carcinoma and ovarian carcinoma, and it~     seems that mesothelin may be utilized as a new tumor marker for ovarian carcinoma. We will~     evaluate that if mesothelin can be a new potential tumor marker for ovarian cancer in this~     proposal.~   "
259296|NCT00155805|"~     By using combination of the expression of COX-2 and NOS and immunologic reaction in the~     esophagus with manometry of LES and cruel diaphragm and 24 hr esophageal pH monitoring to~     investigate the mechanisms and to make a new and more clinically applicable clarification of~     these reflux diseases will be valuable in the clinical management and prevention. We will~     perform the following works and complete the objectives: 1) comparing the difference of~     immuno-inflammatory reactions among NERD, reflux esophagitis and Barrett’s esophagus; 2) the~     different expression of PGs & COX-2 in functional heartburn, hiatus hernia, NERD, reflux~     disease and Barrett’s esophagus; determining the subtype of EP receptor (EP1~4); 3)~     determining and comparing the expression of NOS in the esophagus; 4) investigating the role~     of ROS in the esophagus; 5) in correlating cytokine, COX-2 and NOS with LESP, TLESR,~     diaphragm EMG and 24-hour esophageal pH ; 6) the difference of expression of cytokine,~     atrophic gastritis and Hp in gastric mucosa, in correlating with intragastric acid status,~     among functional heartburn, hiatus hernia, NERD, erosive esophagitis and Barrett’s esophagus;~     to determine whether should eradicate Hp in reflux esophageal disease; 7) the effects of~     lipid peroxidation related immunologic reaction, with relation to COX-2 and NOS, in the~     inflammatory activity and esophageal carcinogenesis of esophagus; 8) the effects of~     cytokines, COX-2 and NOS on the apoptosis in these reflux esophageal diseases; 9) integrating~     immuno-inflamatory reaction, COX-2, NOS with manometry of LES and diaphragm, and 24-hour pH~     monitoring and intragastric pH to newly clarify GERD into evidence based categories.~   "
259297|NCT00155792|"~     Cervical cancer the most frequent neoplasm and the third mortality rate of malignancies of~     the women in the world. It results in about 200,000 women dying of cervical cancer each year~     worldwide. The available forms of treatment-surgery, radiation therapy, and chemotherapy are~     all cytoreductive treatment modalities, so in addition to killing cancerous cells, healthy~     cells are also destroyed in the process. Indeed, there is a need to decrease the incidence of~     cervical cancer and develop better forms of its treatment.~      Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer~     especially those high-risk types (HPV 16,18,31,45) have been strongly associated with~     cervical cancer. HPV 16 was found in more than 50% of cervical cancer tissues. So the host~     immune response plays an important role in determining the regression of cervical abnormality~     or persistence and progression to malignancy via targeting HPV.~      The ideal cancer treatment should be able to eradicate systemic tumors at multiple sites in~     the body while having the specificity to discriminate between neoplastic and nonneoplastic~     cells. In this regard, antigen-specific cancer immunotherapy represent an attractive approach~     for cancer treatment. It is now clear that major histocompatibility complex (MHC) class I~     restricted CD8+ T cytotoxic cells are critical to the generation of antitumor immunity.~     Cell-mediated responses are critical in anti-tumor immunity.~      By cooperating with Dr. TC Wu in Johns Hopkins Medical Institutes, we have recently developed~     some E7-specific cancer vaccines of different strategies such as DNA, or~     replication-defective SINrep5 virus. We found that these E7-chimeric DNA vaccines are capable~     of preventing and treating the growth of murine model tumors expressing E7. These positive~     results from the preclinical murine models have encouraged us to focus on the development of~     cancer vaccine and immunotherapy and apply these vaccines to human subjects. However, it is~     very important to set up various E7-specific immunologic assays of human being to evaluate~     the effect of cancer vaccine or immunotherapy in the future clinical trials. So we would like~     to provide this proposal to address on the development of HPV 16 E7-specific immunologic~     assays in human being.~   "
259298|NCT00155779|"~     The acute respiratory distress syndrome (ARDS) is an important cause of acute respiratory~     failure with a high mortality rate. The mechanism of resolution of the late organizing phase~     remains uncertain. The ACE gene contains a polymorphism based on the presence (insertion, I)~     or absence (deletion, D) within an intron of a 287-bp nonsense DNA domain, resulting in three~     genotypes (DD and II homozygotes, and ID heterozygotes). It has been shown that I/D~     polymorphism of ACE gene may account for half the variance of serum ACE levels in the~     Caucasians. Polymorphism of the ACE gene has also been shown to contribute to the development~     of some respiratory diseases. We hypothesize that the presence of ACE gene polymorphism can~     affect the outcome of ARDS. The objective of this proposed study is to determine the~     genotypes of ACE gene polymorphism and assess the influence of ACE genotype on the outcome~     and pulmonary resolution of patients with ARDS. Patients diagnosed to have ARDS are eligible~     for possible inclusion into the study. The ACE genotype of all patients with ARDS will be~     determined by polymerase chain reaction (PCR) amplification of the respective fragment for~     the D and I alleles from intron 16 of the ACE gene and size fractionation by electrophoresis.~     The outcome of patients with ARDS in the three genotypes will be compared.~   "
259299|NCT00155766|"~     Chemotherapy is the current standard treatment for unresectable recurrent cervical carcinoma~     after radiotherapy or distant metastasis of cervical carcinoma. The most effective regimens~     are cisplatin-based chemotherapy. After failure of the cisplatin-based chemotherapy, there is~     still no treatment that has been proved to be effective.~      Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer~     especially those high-risk types (HPV 16,18,31,45) have been strongly associated with~     cervical cancer. HPV 16 was found in more than 50% of cervical cancer tissues. Results from~     many animal tumor models have indicated that immunization with tumor antigen-pulsed dendritic~     cells can trigger a long-lasting anti-tumor immune response and significantly inhibit the~     growth of implanted tumor cells. Recently, many clinical trials have been conducted to~     evaluate the feasibility and safety of immunizing cancer patients with tumor antigen-pulsed~     dendritic cells. No severe toxicity has been reported and some patients were shown to respond~     to the treatment. Based on previous animal and clinical studies by other investigators, we~     propose to evaluate the potential of immunizing cancer patients with antigen-pulsed~     autologous dendritic cells as a cancer vaccine to treat for recurrent cervical cancers after~     failure of cisplatin-based chemotherapy treatment or refusing chemotherapy. In this study, we~     will generate dendritic cells by culturing patient's autologous PBMC with GM-CSF and IL-4 in~     vitro. These dendritic cells will be pulsed with synthetic peptides representing the CTL~     epitopes on HPV Type 16 E7. Antigen-pulsed dendritic cells will be injected into inguinal~     lymph nodes under the guidance of real-time sonography. Each patient will receive four~     injections and 12 patients in total will be recruited for this study.~   "
259300|NCT00155753|"~     The purpose of this study is to evaluate the possible candidate gene of pathological myopia~   "
259327|NCT00155402|"~     This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular~     surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation,~     Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.~   "
259367|NCT00154856|"~     a further step of our current one-year NSC project, aiming to bridge the above-mentioned gap~     by continuously monitoring the mechanical stimuli applied to the limb and callus, both~     through experimental measurements and FEM calculations, and by correlating the observed~     quantity and quality of the mechanical stimuli with the calculated stress and strain patterns~     of the callus tissue.~   "
259302|NCT00155727|"~     The laparoscopic colectomy has been enthusiastically used by many colorectal surgeons in~     Taiwan, Japan, Europe, and USA, for around 10 years. Further clarification of the~     controversies cited above will be based on the evidence-based medicine, i.e., the randomized,~     well-controlled, prospective clinical trials. Actually, a handful of randomized prospective~     data regarding the laparoscopic colectomy has been appeared in USA and Europe. However, we~     still do not have this kind of data in Taiwan, and therefore this study is important and~     mandatory.~      In this project, we assumed that a difference in cancer-related survival of less then 15%~     between treatments indicates an equivalent efficacy. Assuming a 70% 5-year, cancer-related~     survival of stage II and III colorectal cancer patients in the open colectomy group, a~     minimum of 100 patients per group was required to showed that both surgical techniques were~     equivalent with an α-level of 0.20 and a β error of 0.05. Only patients with stage II and III~     disease undergoing curative resection will be enrolled onto this study. The patients will be~     randomly allocated to either treatment group by block randomization method. Postoperatively,~     the patients will be prospectively evaluated regarding the following parameters including~     operative stress, such as erythrocyte sedimentation rate, serum interleukin-6, WBC counts and~     classification, CD-4 to CD-8 ratio, postoperative life quality, such as wound size, degree of~     pain, time to have flatus passage and feeding, time to resume daily activity and work, and~     the oncological outcomes, such as recurrence patterns of tumor, and 5-year patient survival.~     The evaluation of above-mentioned parameters will be single-blindly done by our research~     assistant, who has no idea of both surgical techniques. We hope this study will promote the~     level of surgical research in Taiwan.~   "
259303|NCT00155714|"~     The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors~     (sildenafil) in primary and secondary pulmonary hypertension~   "
259304|NCT00155701|"~     Several chromosomal loci obtained from genetic linkage studies have been reported of relating~     to schizophrenia. These areas include of 1q32-41, 6p24-21, 8p22-21, 15q13-14, and 22q11-12.~     The names of these genes located in these loci have not been identified, nor have the~     function and the relationship to the disease. Our research team using genetic linkage studies~     has found a strong linkage (NPL Z score = 2.18, p=0.01) between the D1S251 marker and~     schizophrenia disease. This marker is about 4 kb away from DISC1 (disrupted in schizophrenia~     gene 1) gene. In a Scottish family, a balanced translocation [t(1;11) (q42.1;q14.3)] has~     cosegregated inside the schizophrenia affected members of the family (LOD score =6.0). The~     breakpoint of the translocation is located at the intron area between exon 8 and exon 9 of~     DISC1 gene. This translocation disrupted the gene and caused its malfunction. A large~     molecular genetic study study recently in Finland has also demonstrated strong linkage~     evidence (Zmax=3.21) between the DIS2709 marker, located among exon 4 and exon 5 of DISC1~     gene, and schizophrenia in a. All these findings have indicated that DISC1 gene is a~     potential positional candidate gene and worth for further study.~      The main purposes of this proposal include: (1) To evaluate the incidence rate of the~     balanced translocation between the chromosome 1q42.1 and 11q14.3 in approximately 500~     schizophrenic patients in Taiwan. Furthermore, we will compare the clinical symptoms, illness~     course, and family genetic model to examine if any particular characters coexist with the~     translocation. (2) To search for the genetic polymorphisms in DISC1 gene area, where the~     thirteen exons, the promoter regions (1 kb upstream the start codon), and the breakpoint area~     (1 kb of both upstream and downstream area) will be analyzed by the method of denaturing high~     performance liquid chromatography (DHPLC). Case-control association study will be performed~     further in each 200 schizophrenic patients and normal controls to evaluate the relationship~     between the disease and the clinical characteristics.~      This proposal is quite feasible and prospective with the following reasons. (1) All the DNA~     samples and the clinical data have been collected and evaluated completely for further~     analysis. (2) Our research team has built up an integrated andreliable molecular genetic~     laboratory. All the facilities necessary for this study (DHPLC) had been setup with standard~     operating protocols and working routinely. (3) DISC1 gene has strong linkage evidence with~     schizophrenia in Taiwanese sample. The high prior probability of DISC1 gene as a positional~     candidate gene increases the successfulness of association study. . (4) Once the relationship~     among balance translocation, genetic polymorphism and the schizophrenia have established,~     further functional study will be evaluated to understand the possible mechanisms involved in~     the disease.~   "
259305|NCT00155688|"~     We propose to study 900 sib-pairs with the disorder. Our Specific Aims are: 1) To clinical~     assess a pedigree sample having adequate power to detect genes for schizophrenia. 2) To~     conduct a genome scan to find such loci. 3) To transmit all data to the NIMH designated cell~     repository and data management centers. We will attain these goals by achieving the~     following: 1) From Taiwan and China, we will collect 900 Han Chinese sib-pairs having DSM-IV~     schizophrenia. 2) We will examine all family members using the Diagnostic Interview for~     Genetic Study and the Family Interviews for Genetic Study. The PI participated in the~     development and field testing of these interviews and has an already established training~     program for their use. They have been translated into Mandarin by the Taiwanese~     investigators, who have used them in prior studies. 3) Blood samples will be sent to the NIMH~     designated cell repository for creation of lymphoblastoid cell lines. 4) Clinical Data will~     be entered using the database software created for the NIMH Human Genetics Initiative. Data~     will be vetted and sent to the NIMH designated data management center. 5) We will complete a~     genome scan using 450 markers spaced at an average of 10 cM intervals using markers that have~     been optimized for use in the Han Chinese population. The scan will be completed with no cost~     to the NIMH through an agreement with Millennim Pharmaceuticals, a biotechnogy company in the~     the Boston area that the PI has worked with on a prior genetic linkage study of~     schizophrenia. All genetic analyses will be approved by our consultant, Eric Lander, PhD. 6)~     All clinical data will be made available to the scientific community by the end of the~     funding period. All genotypes wil be available one year after they are created but no later~     than a year after the funding period. This project as feasible because 1) The PI has already~     coordinated one multi-site genetic linkage study of schizophrenia and has participated in a~     second. 2) We have a long-standing relationship with our Taiwanese collaborators and an~     effective, albeit, more recent working relationship with our Chinese collaborators. 3) We~     have conservatively estimated that each site has access to more than enough available~     families having two schizophrenic siblings. 4) The PI's Harvard team has had prior experience~     collaborating on genotyping and linkage analysis projects with Millennium Pharmaceuticals.~     This, and Millennium's prior genotyping experience shows that the genotyping phase of the~     work is feasible.~   "
259306|NCT00155675|"~     The Study to evaluate the clinical effect of Gusuibu lasts for 3 years. It aims to evaluate~     its effect on bone density of postmenopausal osteoporosis. Besides, its effects on the liver,~     kidney and the hematological influence will be evaluated, too.~   "
259307|NCT00155662|"~     Occupational injury results in family economic crisis and national productivity loss; it is~     really becoming an important issue in Taiwanese society. Low back pain is the most frequent~     injury affecting workers. In addition to the prevention of injury, having a work-hardening~     program and getting the injured workers returned to work are also challenges for medical~     personnel. The purposes of this study are:~        1. to develop a guideline to assess the low back pain workers' impairment and working~          capacity;~        2. to formulate a feasible work-hardening program for the low back pain workers; and~        3. to execute the program, evaluate the training effect and then follow up the rate of~          return to work of the low back pain workers.~      In the first year, a guideline for assessment of low back impairment and working capacity~     will be developed. It may consist of the demographic data, the working status, the physical~     need in work, trunk muscle isokinetic strength, Oswestry low back disability questionnaire,~     functional capacity evaluation and quality of life questionnaire. The whole assessment~     package will be empirically applied in low back pain workers and the validity and reliability~     will be tested. A work-hardening program for low back pain workers will be established in the~     first year through meetings with experts and literature review. The work-hardening program~     will consist of training of trunk muscle strength, flexibility, and general fitness. A~     sling-exercise training model will be applied in the program. In the second year, low back~     pain workers in outpatient departments will be recruited with their own agreement and grouped~     randomly into either the work-hardening group or the control group. The expected number of~     subjects is 30 in each group. According to the result of impairment assessment and work~     capacity, the workers in the work-hardening group will start the individualized~     work-hardening program for 3 months. After the program, the workers will be assessed again to~     evaluate the training's effect, and the investigators will follow the rate of return to work~     among them 3 and 6 months after the program. The workers in the control group will be~     followed for 6 and 9 months after enrollment to collect the rate of return to work in this~     group.~   "
259308|NCT00155649|"~     This Group of Genomic Research in Psychiatric Disorders (GENOP) located at the Department of~     Psychiatry, College of Medicine and National Taiwan University Hospital (NTUH) had completed~     a serial psychopathological study of schizophrenia (SCH) defined by DSM-IV criteria. The~     results of this GENOP included: (1) delineating 2 to 3 subtypes of schizophrenia with~     prospective follow-up validity; (2) finding a trait marker of impaired attention measured by~     continuous performance test (CPT); (3) impaired executive function assess by Wisconsin Card~     Sorting Test (WCST) and impaired inhibition of P50 evoked potential; (4) five dinucleotide~     repeat polymorphism (DRP) markers in 5 different chromosomes with significant linkage scores,~     including D1S251 at 1q42.1, D6S296 at 6p22 , D8S1222 at 8p14, and D15S976 at 15q14, and~     D22S278 at 22q12; (5) finding a significant linkage of polymorphism marker located in a~     neurodevelopmental gene NOTCH4 ( 6p22); and neurophysiological function related gene CHNRA7~     (15q14); (6) successfully collected 700 multiplex families, collected by the collaboration~     between of NTUH, Taiwan – NIMH, USA in the Taiwan Schizophrenia Genetic Linkage Study (TSLS)~     project, with at least two siblings affected with schizophrenia in Taiwan. A genome-wide scan~     on this big sample will be completed recently in the laboratory of NIMH, U.S.A.. Around 300~     families had also CPT data in the whole family. This is probably the biggest number of~     multiplex families of a single ethnicity all over the world; (7) successfully setting up DNA~     and cell banks as well as clinical data bank. This substantial long track of this GENOP~     provided convincing background for this Positional Cloning Study on Schizophrenia (POCOS).~      Understanding the controversial results of current linkage study on SCH world-wide, this~     POCOS was designed to make a break through design in the study for locating and identifying~     the vulnerability genes of SCH by using (1) phenomenological subtypes; (2) endophenotype~     defined by impaired attention (CPT) and/or impaired executive function (WCST); (3) using~     large enough size of samples of a single ethnicity of Taiwanese family pedigrees.~      Major research tasks include (1) Linkage analysis and quantitative trait loci analysis, in~     collaboration with the team of Harvard Medical School, on the endophenotype defined by~     impaired attention and impaired executive function in 300 families with at least two siblings~     affected with SCH; (2) Two stages of genotyping, using High Throughput technology, of dense~     SNP markers, around DRP markers with significant linkage scores in the NTUH and TSLS studies,~     with average marker interval of 30kb in 3000 subjects of 700 multiplex families (a total of~     300 markers) for linkage and quantitative trait loci analysis; (3) Two stages of study on the~     polymorphisms and/or mutations of candidate genes using association study and TDT test. Each~     stage with 10 Candidate Genes in the NTUH and TSLS project, respectively. In the first stage,~     these are: (a) Neurodevelopmental related genes: DISC1, TRAX (1q42.1), NOTCH4 and TNF(6p21.3)~     and NT-3; (b) Neurotransmitter receptor genes of CHNRA7 (15q14) and NMDA related to attention~     impairment; (c) Neurotransmitter metabolizing enzyme gene COMT (22q11.2) related to impaired~     frontal lobe function; and (d) Pharmacology related genes of DRD3 and 5HTA2.~   "
259328|NCT00155389|"~     Based on a universal eradication of H. pylori in an offshore island (Matsu) with a high~     prevalence of gastric cancer as well as premalignant gastric lesion, we first examined the~     infection rate of H. pylori. Secondly, we evaluated the efficacy of clarithromycin-based~     triple therapy with a levofloxacin-based rescue treatment. And thirdly, we tested the~     hypothesis that whether the cure of H. pylori can reverse the premalignant gastric lesion.~     Fourth, we determine the cost-effectiveness of this intervention. The gene-environment~     interaction will be addressed regarding gastric cancer carcinogenesis. Finally, the incident~     rate of gastric cancer would be followed in this cohort.~   "
259422|NCT00154141|"~     A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding~     during vascular procedures.~   "
259309|NCT00155636|"~     This PPG entitled “A Study on Etiological Factors of Schizophrenia” (SEFOS) focuses on~     searching for the separate etiological factors under the understanding that schizophrenia is~     a complex disorder. Multifactorial model has been most often proposed as the etiological~     model. Up to now, fragmented knowledge of etiological factors, including genetic factor and~     environmental insults were reported in literature, and a two-strike hypothesis has been~     proposed. This PPG of SEFOS formulates a dynamic etiological hypothesis of schizophrenia.~     Specific, however heterogeneous, genes are hypothesized to be located in chromosome 1q, 6P,~     8P, 15q, and 22q; specific environmental insults or stress are hypothesized to be acting in~     the vulnerable brain a long different stages of biological and/or psychological development.~     The interaction of specific genes and specific environment insults/stress along different~     stages of development will result in specific neurobiological abnormalities as shown in~     neuropsychological, neurophysiological and neurochemical/neuroimaging abnormalities. For this~     hypothesis testing, this PPG of SEFOS designs 3 projects of: (1) A Study on Neurobiology of~     Schizophrenia; (2) A Study on Environmental insults/stress of schizophrenia; and (3)~     Molecular Genetics Study of Schizophrenia. Project No.1 aims at finding different levels of~     neurobiological and anatomical abnormalities; Project No.2 aims at finding different levels~     of environmental insults/ stress; Project No.3 aims at locating vulnerability genes in~     different chromosome regions. A core unit for administrative integration, for case/family~     recruitment and statistical analysis is also designed. The dynamic etiological complex will~     be explored under multivariate statistical analysis. This PPG of SEFOS adopts~     multidisciplinary approach including clinical psychiatrists, psychopathologists,~     neuropsychologist, neurophysiologist, neuroimaging (magnetic resonance imaging) specialist,~     genetic epidemiologist, molecular genetic specialist, genetic statistician, and~     biostatisticians. This team has sound mutual trust base on the experience of being working~     together and attending regular research meeting for the part several years under the~     leadership of the principal investigator of this PPG.~   "
259310|NCT00155623|"~     The aims of this prospective study are: (1) to prospectively investigate the true~     prevalence rate, the acquisition and spontaneous clearance of H. pylori infection year by~     year in the population whose ages between seven and fifteen. (2) to explore the risk factors~     of transmission of H. pylori infection in Taiwan. (This information may be use as the guide~     for conduction of the national policy of public health and disease prevention.)~   "
259311|NCT00155610|"~     The investigators will recruit a cross-sectional group of diabetic women in internist~     clinics. UDS will be applied for voiding function in each case. Intravesical electrical~     stimulation will be used to test CPT per 5 Hz, 250 Hz, 2000 Hz for the patients. The~     differences of intravesical CPT between diabetic women with and without voiding dysfunction~     will be determined.~   "
259312|NCT00155597|"~     The aims of this study are:~        1. To develop a disease-specific questionnaire for hip fractures.~        2. To find the influences of physical therapy (PT) on patients' function and health-related~          quality of life (HRQL).~        3. To estimate the quality adjusted life years (QALY) of cases of hip fracture with or~          without the PT program by a quality-adjusted survival (QAS) method.~        4. To perform cost effectiveness analysis (CEA) to evaluate the effectiveness of PT and as~          a base to compare it with other health intervention programs.~      At the beginning of the study, the investigators will develop the disease-specific~     questionnaire for hip fractures. Cases of patients with hip fractures hospitalized in~     orthopedic wards of the National Taiwan University Hospital (NTUH) and Chung-Hsing Hospital~     of Taipei from August 1, 1989 to July 31, 1999 are the study population during the first year~     of this study. According to their receiving PT or not during hospitalization, the patients~     are assigned to a PT or non-PT group. The identification (ID) numbers will be matched with~     the death certificate file of the Department of Health to verify the survival status.~     Furthermore, 30 cases per group per year will be randomly sampled to interview their HRQL and~     evaluate their function with the disease-specific questionnaire for hip fractures. Combining~     the survival function and HRQL, the QALY could be estimated. Cases of hip fracture admitted~     to the orthopedic ward of NTUH and receiving a PT program from January 1, 2000 will be the~     second-year study population in this study. They will be randomly assigned to a group of~     follow-up PT (group I) or non-follow-up PT (group II). The patients assigned to group I will~     have a 4-time PT evaluation and treatment at home after discharge from the hospital (1 week,~     1 month, 3 months and 6 months after discharge). All patients will be evaluated at discharge,~     1 month, 6 months, and 1 year after discharge to follow their survival status, functional~     status and HRQL. The expected results of this study will be to develop the disease-specific~     questionnaire for hip fractures, to show the functional outcomes of cases of hip fracture,~     and to estimate the QALY of them.~   "
259313|NCT00155584|"~     Photodynamic therapy (PDT) has been developed as a promising new cancer treatment modality,~     which involves the uptakes of a photosensitizer by tumor cells, followed by the activation of~     photosensitizer with approximate wavelength of light. The mechanisms of the PDT-induced~     cytotoxic effect relate to singlet oxygen and other reactive oxygen intermediates generated~     by PDT, which give rise to cellular stress and cause cell death. Previously, using the~     homemade LED light source, we have shown that ALA-PDT is effective for the treatment of~     premalignant lesions such as mucosal dysplasia and carcinoma in situ of oral cavity. Due to~     the advantages of low cost, high reliability, and portability, LED light source provides an~     alternative approach for the light irradiation of PDT.~      Verruca vulgaris are benign skin papillomas caused by the human papilloma virus (HPV). They~     are very common and can affect many different sites including the face, hands, feet and~     genitalia. Although the present therapeutic approaches are more or less effective in~     eradicating the lesions, relapses are very common. Furthermore, at times the anatomical~     location and depth of lesions often make the treatment difficult, time-consuming and painful.~     Therefore, it is necessary to develop new modalities for wart treatment.~      The purpose of this clinical trial is to develop topical ALA-PDT as an alternative treatment~     of wart but without the unwanted side effects of pain and burning. To fulfill this goal, the~     following works will be performed. First, topical ALA formulation and LED array will be~     specifically designed and developed for the skin lesions. Second, the efficacy of the ALA~     formulation designed for wart treatment will be evaluated with in vivo fluorescence imaging~     system. Third, the therapeutic efficacy of ALA-PDT will be evaluated by using a LED array~     designed for skin irradiation. Forth, the unwanted side effects of pain and burning will be~     further compared between red and green LED array.~   "
259314|NCT00155571|"~     Periodontal disease is considered to be an infection disease. Recent evidence supported the~     role of smoking as a potent risk factor for the development of periodontal disease. However,~     the effect of another oral habit, betel quid chewing on periodontal tissues has not been well~     determined. The purpose of the present study is to analysis the role of bacteria on the~     periodontium in the betel quid chewers. Plaque samples will be collected from betel quid~     chewers and the occurrence of periodotopathogens will be analyzed Since most chewers also~     smokers, plaque samples from age matched smokers but not betel chewers and non-smokers will~     analysis for comparison. An in vitro test is also performed to evaluate whether the extract~     has a direct inhibitory effect on common periodontal pathogens, such as Porphyromoans~     gingivalis, Bacteroides forsythus, Actinobacillus actinomycetemcomitans.~   "
259315|NCT00155558|"~     To determine the maximum tolerated dose and dose limiting toxicity of 5-FU and leucovorin~     with novel 48-hour infusion schedule, and to collect toxicity profile at different dose level~     of 5-FU/LV 48-hour infusion.~   "
259316|NCT00155545|"~     The purposes of this study are to use motion analysis techniques to study the biomechanical~     interactions between the spine and the lower limbs in scoliosis patients with or without leg~     length discrepancy (LLD) during activity; to investigate the effects of correction of LLD:~     using foot orthosis on the functional scoliotic spinal curve and motion during functional~     activity; and to test whether idiopathic scoliosis without LLD can be improved by~     artificially creating a leg length discrepancy with a foot orthosis.~   "
259317|NCT00155532|"~     To address the issues of skin denervation and its clinical and pathological correlations in~     systemic lupus erythematosus~   "
259329|NCT00155376|"~     Morphine can induce constriction of sphincter of oddi and glucagon can facilitate bile~     secretion and dilatation of bile duct. We conduct this randomized double blinded study to~     evaluate the effect of enhancement in MRCP using intravenous morphine and glucagon.~   "
259442|NCT00153881|"~     The primary objective is to determine the maximum tolerated dose of oral capecitabine, in~     combination with fixed doses of weekly docetaxel, and concurrent thoracic radiation for the~     treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal~     junction.~   "
259318|NCT00155519|"~     Current diagnostic criteria of schizophrenia are based on marked positive and negative~     symptoms. This definition may impede the exploration of basic phenomenological~     psychopathology or pathological mechanism of schizophrenia. Schizophrenia was found to have~     neuroanatomical, neurophysiological and neuropsychological impairment. However, the existence~     of these basic pathological states may not manifest as clinical state of schizophrenia, and~     it is found in normal relatives of schizophrenia proband. The clinical state of this~     underlying pathology may include so-called latent or early, or pseudo-neurotic schizophrenia~     or schizotypal disorder. The manifestation of prominent neurotic symptom state may not only~     present as an psychopathological issue, but also induce misdiagnosis in clinical practice.~     This may interfere early diagnosis of schizophrenia and may delay the chance of early and~     appropriate treatment.~      Taking the fact of this disadvantaged conditions, this research is for exploration of~     clinical pathology and neuropsychological functions of latent or pseudo-neurotic~     schizophrenia. The strategy ia a natural follow-up study on the clinical cases obtained from~     the registration record of the medical charts of the National Taiwan University Hospital from~     1970 to 1995. The natural follow-up results till study time (5 yrs to 30 yrs following~     period) will be explored. By using neurotic group (50 cases), latent schizophrenia group (50~     cases) and schizotypal group (30 cases), the differences in clinical pathology,~     neuropsychological functions and family history of schizophrenia will be examined. There are~     5 hypotheses to be tested: (1) Schizotaxia may exist as the manifestations of latent~     schizophrenia, schizotypal disorder and frank schizophrenia. The severity of pathology~     increased step by step; (2) The syndrome may change from the lower order to higher order to~     higher order, but not all of them changed to the higher order; (3) The clinical pathology of~     latent schizophrenia has both neurotic symptom as well as basic symptoms of schizophrenia;~     (4) There is the same kind of neuropsychological impairment of schizophrenia in the group of~     latent schizophrenia, and (5) The prevalence of schizophrenia in the first degree relatives~     of latent schizophrenia is higher than that of the general population. Finally, this study~     results will help the establishment of valid screening and/or diagnostic method (criteria) of~     latent schizophrenia for clinical and research usage.~   "
259319|NCT00155506|"~     Schizophrenia is a chronic and devastating major psychiatric disorder. Family, twin, and~     adoption studies indicated that schizophrenia has a significant genetic component. The mode~     of transmission is still not clear and a multilocus model was proposed. The location of~     susceptibility gene of schizophrenia is still under active search using molecular genetic~     methods.~      We propose to collect genomic DNA and lymphoblast cell lines of a total of 150 DSM-IV~     schizophrenic patients and their first degree relatives including parents (parent-offspring~     trios) and non-affected siblings in three years. Adequate statistical power of molecular~     genetic studies is a great concern. For this concern, we will examine the patients and their~     parents clinically by using the Diagnostic Interview for Genetic Studies (DIGS) for~     diagnostic assessment, and by using neuropsychological battery including sustain attention,~     executive function, verbal memory and general intelligence for neuropsychological~     evaluations.~      The project is feasible because (1) The PI and his research team have experience in~     successfully collecting co-affected sib-pair families of schizophrenia and in setting-up~     molecular genetic laboratory in the past decade. We are experienced and competent to execute~     this project. (2) The PI and his research team have established the instruments using to~     clarify the phenotypes including the DIGS, the neuropsychological battery these years.~      Major goals of this project are: (1) to cooperate with this important Taiwan Genotype~     Consortium proposed by the NHRI; (2) to detect major schizophrenia susceptibility genes~     related to the neuropsychological endophenotype; (3) to do further fine mapping on suggestive~     linkage markers to replicate previous linkage studies results using our previously-collected~     co-affected sib-pair family sample; and (4) to deposit the lymphoblast cell lines into NHRI~     Cell Bank serving as a national resource for basic research in Taiwan.~   "
259320|NCT00155493|"~     Periorbital rejuvenation has been an issue of great interest in plastic surgery. Adipose~     tissue plays an important role in the periorbital anatomy, and has a great impact on the~     aging process of the region. We believe age-related atrophy of the facial adipose tissue may~     be related to the decreased proliferation and differentiation capability of the preadipocytes~     (adipose precursor cells).~   "
259321|NCT00155480|"~     This study will be using finite element meshes and averaged algorithms to create the~     numerical thoracic aorta at different ages.~   "
259322|NCT00155467|"~     Setup CT images database of congenital heart disease.~   "
259323|NCT00155454|"~     Recurrent vitreous hemorrhage after vitrectomy for complications of diabetic retinopathy is a~     common occurrence. The hemorrhage may appear within the first few weeks after surgery or~     months later. This complication may delay visual rehabilitation significantly and sometimes~     requires additional procedures or surgery, jeopardizing previous successful operation. The~     causes of bleeding are diverse. While evidence suggests fibrovascular proliferation from the~     sclerotomy sites or in the vitreous base may be an important source of recurrent vitreous~     hemorrhage, other origins of hemorrhage exist including lysed clot from residual vitreous~     skirt, injured retinal vessels from surgery, and incompletely removed fibrovascular tissues.~     The latter three conditions may be the major sources of early postoperative vitreous~     hemorrhage. We have shown that peripheral retinal cryotherapy along with cryo treatment at~     the sclerotomy sites may effectively reduce the incidence of fibrovascular proliferation at~     the inner surface of sclerotomy sites and prevent the late-onset recurrent vitreous~     hemorrhage. However, many patients still experience disturbing vitreous hemorrhage within the~     first two to three weeks after post-operative transient clear-up of the vitreous. We~     hypothesize that gas bubble within the vitreous cavity may mechanically temponade the fragile~     retinal vessels, and concentrate the coagulation factors in the vitreous cavity, allowing the~     integrity of vessel walls gradually recovers and thus preventing the occurrence of early~     postoperative recurrent vitreous hemorrhage.~      To test this hypothesis, a clinical study was undertaken to investigate the effect of~     long-acting gas infused into the vitreous cavity at the end of diabetic vitrectomy in the~     prevention of recurrent vitreous hemorrhage.~   "
259324|NCT00155441|"~     Sleep disturbance is prevalent in chronic dialysis patients and there is a negative~     correlation between the quality of life and overall survival and sleep disturbance in them.~     Cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically. In~     previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis~     patients. This study tries to elucidate its therapeutic effect on the sleep disturbance in~     chronic peritoneal dialysis patients.~   "
259325|NCT00155428|"~     Using biocardiac model in helping the total correction of the Tetralogy of Fallot.~   "
259326|NCT00155415|"~     Colorectal cancer (CRC) is the leading cause of cancer death not only in the Western~     countries but also in Taiwan. Colonoscopy is now gradually accepted as one of the powerful~     tool for colorectal cancer screening. Not only for survey after positive fecal test, it is~     also applied as primary screening modality for CRC screening.Colon cleansing before~     colonoscopy thus becomes critically important and inadequate preparation may lead to low~     diagnostic yield with missed lesions, increased risk of complication and prolonged procedure~     time. Though the importance of good colon preparation can not be over-emphasized, diet~     control before colonoscopy and ingestion of large amount of lavage solution remain a~     significant hurdle to overcome and investigators continue to seek for the ideal colon~     preparation with respect to quality and examinee satisfaction. After the introduction of~     polyethylene glycol electrolyte lavage solution (PEG-ELS) for bowel preparation before colon~     procedures, its safety was well documented and the efficacy of colon cleansing was proven~     efficient. The timing of ingesting PEG-ELS is different between institutes and some ingest~     PEG-ELS as a whole at the night before colonoscopic examination and some ingested in~     split-dose manner which ingest half of the solution at previous night and remaining on the~     day of examination. Some institutes ask examinee to receive lavage solution on the day of~     examination. The manufacturer advices start taking medication on the day before the~     investigation according to their printed instruction on the package of PEG-ELS. Though there~     were a lot of studies that conducted to describe the result of colon cleansing in different~     fashion, the result is still controversial. This prospective, randomized, single-blinded~     trail evaluated and compared the efficacy of colon preparation at two timing of colon~     preparation, namely, in previous night or on the day of colonoscopic examination. In this~     study, we enrolled those who have already colon neoplasia detected during voluntary routine~     health check-up and received second colonoscopic examination for either elective polypectomy~     or endoscopic mucosectomy (EMR). We used not only the cleansing condition as a reference of~     adequate preparation; we also compared the diagnostic yield of lesion number as an objective~     comparator between these two methods.~   "
259330|NCT00155363|"~     Adiponectin, an adipose tissue derived protein, with anti-inflammatory properties that is~     secreted from adipose tissue, is associated with insulin resistance. It has been shown to be~     a predictor of cardiovascular events in both the general population and patients undergoing~     hemodialysis. Adiponectin levels were inversely related to body mass index values, plasma~     leptin levels, insulin levels, serum triglyceride levels, and homeostatic model assessment~     index values. In addition to it’s ability in increasing insulin sensitivity, adiponectin was~     demonstrated to have anti-inflammatory and anti-atherogenic properties. In patients with~     ESRD, renal replacement method was either peritoneal dialysis or HD. High efficient dialysis~     methods such as high flux HD and HDF had been used more and more popularly. High flux HD and~     HDF have the advantages in middle to large molecule removal, and better hemodynamic~     stability. Better clinical prognosis has been shown in patients undergoing high flux HD or~     HDF. Although studies have demonstrated that the plasma adiponectin levels were elevated in~     patients receiving HD, whether different dialysis modality will interfere the plasma~     adiponectin levels and patients’ prognosis remain unknown. The current project is planned to~     investigate the effects of different HD modality on the plasma adiponectin levels and its~     correlation other serum inflammatory markers and vascular function. Patients’ long term~     prognosis will also be assessed in the present study.~   "
259331|NCT00155350|"~     In this study, we, the investigators at National Taiwan University Hospital, will evaluate~     the efficacy of pharmacological therapy targeted to reduce insulin resistance (pioglitazone)~     on the progression and compositional change of non-obstructive coronary atherosclerotic~     plaques and coronary calcification by serial intravascular ultrasound~     (IVUS)/multi-detector-row computed tomography (MDCT) follow-up in patients with type 2~     diabetes or non-diabetic metabolic syndrome during a 2-year period.~   "
259332|NCT00155337|"~     Photodynamic therapy for oral leukoplakia and erythroleukoplakia~   "
259333|NCT00155324|"~     The aim of the study is to investigate the effect of extracorporeal shock wave therapy (ESWT)~     on the thickness of plantar fascia measured by ultrasonographic examination among patients~     with chronic plantar fascitis. The change of plantar fascia thickness will be correlated with~     clinical improvement.~   "
259334|NCT00155311|"~     To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone~     samples will be collected from partially impacted third molars after orthodontic uprighting~     for different period of time in volunteers. In situ hybridization and immunohistochemistry~     analysis for OPG and RANKL will reveal their roles in this physiological process.~   "
259335|NCT00155285|"~     To test the ability of multi-detector spiral CT in evalting the infant complex congenital~     heart disease.~   "
259336|NCT00155272|"~     This is a pilot study of concomitant radiotherapy and thalidomide for patients with locally~     advanced HCC.Besides toxicity and efficacy, mechanistic studies including dynamic contrast~     enhanced MRI and serum cytokines will be evaluated.~   "
259337|NCT00155259|"~     The primary endpoint of this phase II trial is the objective response rate of the regimen.~     The secondary endpoints include treatment-related toxicity, progression free survival and~     overall survival and breast conserving rate.~   "
259338|NCT00155246|"~     To study whether pentoxifylline has additive renoprotective effect in patients taking ARB~   "
259339|NCT00155233|"~     1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist~        2. This study was designed to investigate the interaction between nalbuphine and morphine~   "
259340|NCT00155220|"~     There are 2 parts to this study.~      First part:~        -  Reliability of water displacement, circumference, tonometer.~        -  Effect of taping: lifting effect measured with sonography~        -  Effect of taping: peripheral circulation measured with DRT4~      Second part:~        -  Effects of different intervention models including decongestive lymphatic therapy (DLT)~          and modified DLT~   "
259341|NCT00155207|"~     This project entitled “A Study on Risk Mutations of the Vulnerability Genes of Schizophrenia”~     (RIGOS) is a continuous effort following the well founded and arduous work of genetic study~     on schizophrenia (SCH) by the Genomic Psychiatry Study Group (GENOP) of National Taiwan~     University Hospital. So far the GENOP has established several important data banks, including~     DNA bank and lymphoblastoid (EVB transformed) cell bank of 725 affected sib-pair SCH~     families, 200 Trio SCH families, and 150 normal controls; and the clinical database of serial~     follow-ups. An ongoing project, Positional Cloning Study on the Vulnerability Genes of SCH~     (POCOS), carried out by the GENOP has found 11 candidate vulnerability genes with identified~     expression in the brain. Besides, on the basis of two related projects, the Multiple~     Psychopathological Study of SCH (MPSS) and the Etiological Study on SCH (SEFOS), the GENOP~     has established endophotype indicators for schizophrenia in neuropsychological and~     neurophysiological domains. The GENOP, a multidisciplinary research team, is thus ready to~     search for risk mutations of the candidate vulnerability genes for schizophrenia in this new~     proposal.~      The basic strategy of this RIGOS Project is to search for risk mutations, based on~     case-control design with sufficient statistical power, and then to validate these risk~     mutations by convergent evidence of genetic epidemiological analyses, functional variation~     studies using in vitro cell line experiments, microarray study, and neurophysiological study~     (PPI) on mice model. Thus, this RIGOS Project has integrated 5 lines of experimental designs~     to achieve 5 specific aims to identify and validate the risk mutations from 11 candidate~     vulnerability genes found in the ongoing POCOS project based on Taiwanese Sample.~      We are confident to be at the frontier work of searching for the risk mutations, with~     functional validity, of SCH. The achievement of the RIGOS will be a mile stone to create new~     era of genetic functional study to tackle pathophysiological mechanism of SCH and will be the~     basis of developing novel diagnostic method and novel intervention method at the early stage~     of SCH in the future.~   "
259342|NCT00155194|"~     Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have~     systemic immunity defect.~   "
259343|NCT00155181|"~     EBV, infection process, immortalization, B lymphocytes, Epithelial cells, co-culture~     Epstein-Barr virus (EBV) belongs to human γ-herpes viruses. Unlike other human herpes~     viruses, EBV can only predominately infect two types of human cells: lymphoid cells and~     epithelial cells and its infection is associated with several human malignancies of these two~     cell types. The lymphoid cancers associated with EBV infection include Burkitt’s lymphoma,~     Hodgkin’s disease, B lymphoma in immunodeficient patients and T/NK cell lymphoma. The~     carcinomas associated with EBV are nasopharyngeal carcinoma and gastric carcinoma. One unique~     biological feature of EBV is that it can infect and immortalize primary B lymphocytes in~     vitro into lymphoblastoid cell lines (LCL). So far, limited information is known about the~     whole EBV infection process and its regulation mechanism for immortalization. In this~     project, three EBV infection models are setting up to reveal the cellular events and signal~     transduction pathway possibly involved in EBV infection process and immortalization course of~     action.~   "
259477|NCT00153426|"~     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,~     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors~     to prevent, delay and control cardiovascular and other chronic diseases.~   "
259345|NCT00155155|"~     Taiwan is a hyperendemic area of hepatitis B virus (HBV) infection. Previous studies~     demonstrated vigorous T cell responses to HBV-encoded antigens developed in patients with~     self-limited acute hepatitis B. In contrast, weak or no T cell responses could be detected in~     chronic hepatitis B (CH-B) patients. However, these immune responses are still not well known~     in patients with acute exacerbation (AE) of CH-B and in patients with advanced liver~     diseases, such as liver cirrhosis (LC) and hepatocellular carcinoma (HCC). The CD4+CD25+~     regulatory T cells might suppress immune responses against foreign antigens and pathogens.~     The roles of CD4+CD25+ regulatory T cells in patients chronically infected with HBV remain to~     be clarified. The high percentage of HBV carriers in Taiwan are related to the vertical~     transmissions. High maternal HBV viral load may make the newborns tolerant to the HBV.~     However, the HBV-specific CD8+ T cells responses in the cord bloods of newborns are still~     unknown. Thus, we want to resolve these issues in this study. We will enroll the HBsAg (+)~     patients from NTUH. Blood samples will be collected. We will then analyze the HBV-specific~     CD8+ T cell responses and the clarify the roles of regulatory T cells.~   "
259346|NCT00155142|"~     To address the following issues: (1) the course of small nerve fiber degeneration in type 2~     diabetic patients, especially in asymptomatic patients; (2) the influence of blood sugar~     control on development of the small fiber degeneration; (3) the correlation of skin~     innervation with sensory thresholds, autonomic tests and parameters of nerve conduction~     studies; and (4) the role of neurotrophins in diabetic neuropathy, we will perform skin~     biopsy with quantification of IENF in type 2 diabetic patient without neurological symptoms.~     The investigations all include clinical evaluation, electrophysiological studies,~     quantitative sensory test and enzyme linked immunosorbent assay of neurotrophins. The~     analysis of skin innervation with diabetic parameters will give important insights into the~     mechanism, prevention and management of small fiber neuropathy in neurologically asymptomatic~     type 2 diabetic patients, and also therapeutic strategies for diabetic neuropathy.~   "
259347|NCT00155129|"~     The release of the neuropeptide calcitonin gene-related peptide (CGRP) is thought to play a~     causative role in migraine. Nociceptin immunoreactivity and ORL-1 mRNA have been detected in~     human trigeminal ganglia where it was co-localized with CGRP. It may play a role in migraine~     pathogenesis. We are collecting the blood samples of migraineurs for analysis of these~     neuropeptides.~   "
259348|NCT00155116|"~     To evaluate the correlation between SERPIN D1 expression in clinical specimen (including~     surgical specimen and blood sample) and lung cancer metastasis.~   "
259349|NCT00155103|"~     The purpose of this study is to determine the effect of polymorphisms in the IL-1 gene~     complex on the development of chronic hepatitis and hepatocellular carcinoma.~   "
259350|NCT00155090|"~     Magnetic resonance spectroscopy (MRS) is a diagnostic technique in MRI that distinguishes~     various metabolites on the basis of their slightly different chemical shifts or resonance~     frequencies. The Proton is the most abundant nucleus in the body. We will try to establish~     the typical proton MRS pattern of normal women breasts to be a guideline for future further~     investigations.~   "
259351|NCT00155077|"~     Carcinoma of the uterine cervix is a serious health problem. Cervical cancer is the most~     common malignant neoplasm of women in Taiwan. There were 2,720 new cases of invasive~     carcinoma of the cervix and 971 deaths from the disease in 2000. Cervical cancer is indeed is~     an important disease in Taiwan.~      The primary therapies for cervical cancer are surgery, radiotherapy or chemoradiotherapy.~     Several clinical trials have showed that an improvement in time to progression and survival~     for patients given chemoradiotherapy compared with radiotherapy alone. Chemoradiotherapy is~     now regarded as standard modality to treat the locally advanced (stage IIB–IVA) or high-risk~     early-stage cervical cancer. However, some of the cervical cancer patients still failed to~     response to the treatment of cervical cancer or relapsed for completion of treatment.~      Angiogenesis plays an important role in the pathogenesis of cancer. Recent studies have~     related angiogenesis to cancer growth and metastasis Ultrasonography has been used in the~     gynecologic field for decades. The previous studies of our team have shown that incremental~     angiogenesis could be demonstrated in the tumorigenesis of ovarian, endometrial malignancies,~     and cervical caner. Besides, other growth factors such as vascular endothelial growth factor~     (VEGF), and IL-6 have also been reported to correlate with the angiogenesis and the prognosis~     of cervical cancer. It seems that tumor angiogenesis could be utilized as a good marker to~     survey the severity of disease and prognosis of early-staged cervical cancer patients.~      There is no good method or marker which could be utilized to monitor the response of~     radiotherapy and evaluate the prognosis of cervical cancer patients with advanced stages. So~     we would like to propose this proposal to focus on the tumor angiogenesis in cervical cancer~     patients with advanced stages. There are several purposes in this study. First, we will~     evaluate the kinetic changes of tumor angiogenesis in cervical cancer patients who receive~     radiotherapy or concurrent chemoradiotherapy. Second, we will evaluate that if the tumor~     angiogenesis could be a marker to monitor the response of radiotherapy or chemoradiotherapy~     in cervical cancer patients. The relation between tumor angiogenesis and radiotherapy will be~     explored and clarified by this study. The comprehensive role of tumor angiogenesis in~     cervical cancer will be elucidated by the results of this study.~   "
259352|NCT00155064|"~     The tissue kallikrein-kinin (KKS) and renin-angiotension-aldosterone system (RAAS) had been~     implicated in regulating blood pressure and electrolyte homeostasis. Both of the KKS and RAAS~     may work coordinately to regulate salt metabolism, local blood flow. Thus, we conducted this~     study to elucidate, first, whether some alterations in components of the kallikrein-kinin~     system could do effect on aldosterone secretion.~      Previous study has shown the post captopril plasma aldosterone concentration (PAC)/ plasma~     rennin activity (PRA) ration (ARR) was a reliable method for diagnosis of primary~     aldosteronism (PA). The ARR change by angiotensin II receptor blockade was reported to be~     significantly higher than that by ACE inhibitor. This study assessed whether angiotensin II~     receptor blockade offers any additional advantage in the diagnosis of PA. Clinically we~     evaluated the sensitivity and specificity of captopril (angiotensin-converting enzyme~     inhibition) and losartan (angiotensin II type 1 receptor blocker) test in PA patient. This~     interaction mechanism, in term, could further explain the interaction of KKS and RAAS.~   "
259363|NCT00154921|"~     Traditional biopsy requires the removal, fixation, and staining of tissues from the human~     body. Its procedure is invasive and painful. Non-invasive in vivo optical biopsy is thus~     required, which should provide non-invasive, highly penetrative, three-dimensional (3D)~     imaging with sub-micron spatial resolution. Optical biopsy based on scanning two-photon~     fluorescence microscopy (TPFM) is a good method for biopsy of skin due to its high lateral~     resolution, low out-of-focus damage, and intrinsic three-dimensional (3D) section capability.~     However current technology still presents several limitations including low penetration~     depth, in-focus cell damages, and multi-photon phototoxicity due to high optical intensity in~     the 800 nm wavelength region, and toxicity if exogenous fluorescence markers were required.~     We study the harmonics optical biopsy of a human skin sample using a femtosecond~     Cr:forsterite laser centered at 1230 nm. Higher harmonics generation is known to leave no~     energy deposition to the interacted matters due to their energy-conservation characteristic.~     This energy-conservation characteristic provides the “noninvasive” nature desirable for~     clinical imaging. In our study, we will evaluate the clinical applications of optical skin~     biopsy using harmonic generation microscopy.~   "
259353|NCT00155051|"~     Long term treatment of progestin has been demonstrated to have an inhibitory effect on~     endometrial angiogenesis and the proliferation of endometrial stromal cells. As a result,~     progestin is now widely employed in the treatment of endometrial cancer, endometrial~     hyperplasia, and dysfunction uterine bleeding. In the treatment of adenomyosis, however, the~     beneficial effect of progestin was limited. It might imply that the behavior of endometrial~     cells in women with adenomyosis is different from that in women without adenomyosis.~      Our previous study revealed that the expression of killer inhibitory receptors (KIRs) on NK~     cells was decreased in eutopic endometrium in women with adenomyosis. It may be a~     compensatory effect in which the NK cytotoxicity is activated in order to wipe out the~     abnormal endometrial cells that might go out of the eutopic site of endometrium. It implies~     that the formation of adenomyosis might be due to “abnormal” endometrial tissues, but not the~     aberrant local immunological dysfunction in myometrium. This finding is compatible with~     previous reports in which eutopic endometrium obtained from women with endometriosis or~     adenomyosis was found to behave differently from endometrium in unaffected women.~      In this study, we try to collect endometrial tissues from women with and without adenomyosis,~     and then purify the endometrial stromal cells from endometrium. The endometrial stromal cells~     are cultured for 8 days with the supplement of medroxyprogesterone (MPA) or danazol.~     Quantification of IL-6 and IL-8 mRNA in endometrial cells, and the concentrations of IL-6 and~     IL-8 in cultured media will be done with real time RT-PCR and ELISA respectively. The~     expression of different cytokines of endometrial cells in response to progestin might be~     further elucidated after our experiment.~   "
259354|NCT00155038|"~     To evaluate if there is any imaging characteristic of breast cancers in women younger than 40~     years of age.~   "
259355|NCT00155025|"~     To investigate the prevalence of family history in prostate cancer patients in Taiwan and~     evaluate the association of variation of diseases and family history~   "
259356|NCT00155012|"~     1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the~     relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical~     management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of~     coronary CT angiography and the influence of coronary calcium score on coronary CT~     angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.~   "
259357|NCT00154999|"~     The oxygen tension increases more than 3 times from fetus to neonate. The oxidant stress~     happens. And it will cause the destruction of RBC. So, we propose that the ROS may play an~     important role of neonatal hyperbilirubinemia. There is strong association between the~     bilirubin level and ROS levels at 3 days old in our pilot study.~   "
259358|NCT00154986|"~     An ovarian cancer cell line (OVTW-59) derived from an ovarian endometrioid carcinoma was~     established and its sublines, labeled as P0, P1, P2, P3, and P4 with increasing invasion~     abilities were selected from transwell invasion chambers.Using cDNA microarray and verified~     with quantitative reverse-transcriptase polymerase chain reaction, we have identified IGFBP-3~     as an invasion-suppressor gene. We plan to study the role of IGFBP-3 in ovarian cancer~     invasion.~   "
259359|NCT00154973|"~     Expression of hypoxia-inducible factor-α in oral precancers and cancers~   "
259360|NCT00154960|"~     In this, here we want to present a new method for analysis variation in gene copy number for~     patients and carriers of SMA. This is a relative quantitation method and, therefore, relies~     on the inclusion of one or more internal control or reference sequences; quantitation of DNA~     is relative to this reference sequence of known copy number. A peak height from within a~     potentially duplicated or deleted target region is amplified simultaneously with a disomic~     reference region in a multiplex PCR system.~   "
259361|NCT00154947|"~     With the current therapeutic focus in rheumatoid arthritis (RA) shifting from symptom control~     to actual disease modification there is a growing demand for more objective and sensitive~     ways to evaluate structural damage in the joints of these RA patients. Conventional~     radiography of bone erosion and joint-space narrowing was the only imaging approach available~     for this. Now significant advantages are offered in terms of speed, precision and scope over~     conventional methods. These advances include digital radiography and computer aided analysis~     as well as MRI which allow earlier identification of bone erosion and direct visualization of~     pre-erosive changes, such as bone inflammation and synovitis. Molecular markers of tissue~     turnover have been used for decades in clinical trials of osteoporosis, but only recently in~     RA. In contrast to serum C-reactive protein (CRP), which is only a nonspecific indicator of~     systemic inflammation and not directly reflective of structural damage to joints, more~     recently developed molecular markers of synovial, cartilage and bone turnover might provide a~     better indication of destructive activity of the disease. Compared with radiography and MRI~     assessment, molecular markers are particularly useful for patient selection and treatment,~     but can be used in a variety of ways to accelerate clinical trials and reduce the uncertainty~     and cost of drug development. In this project, we will set up a panel of molecular markers~     which could show an association with the MRI results and have a quantitative correlation with~     the degree of joint damage (sensitivity: 90 – 95%; specificity: 80 – 90%). The work in this~     project includes imaging markers evaluation and molecular markers analysis: X-ray scoring;~     MRI; Bone degradation markers; Bone formation; Cartilage degradation; Cartilage synthesis;~     Synovial turnover and Others. Nine molecular markers will be examined: CartiLaps~     ELISA/CTX-II, Urinary CrossLaps ELISA/CTX-I, and Serum osteocalcin, Serum COMP, MMP-3, Serum~     PINP, Serum PICP, Urinary PIIINP and Serum YKL-40. The data will be managed to evaluate the~     significance of correlation to image and clinical reports, so as to get a simple algorithm of~     parameters (molecular markers) which can reflect the structural damage of joint using~     mathematics and computer science.~   "
259362|NCT00154934|"~     Preeclampsia is a severe complication of human pregnancy. It occurs in 4-5% of all~     pregnancies and remains a leading cause of maternal and neonatal mortality and morbidity. The~     pathophysiology of this syndrome is not fully understood. Two theories are proposed to~     explain the development of preeclampsia: defective trophoblast invasion in the first~     trimester, and poor maternal immunoregulation against the fetus. Pro-inflammatory cytokines~     are induced in the second mechanism, with a subsequent generalized endothelial dysfunction in~     the mother. Interleukin-10 (IL-10) plays a major role in this pathway.~      According to recent literature, debates still exist on the role of IL-10 in the pathogenesis~     of preeclampsia. IL-10 may increase immunoregulation (seemingly against the development of~     preeclampsia), but also prohibit the extravillous trophoblast invasion on the other hand~     (seemingly towards the development of preeclampsia). According to recent authoritative~     journals, the expression of IL-10 pre-eclamptic placenta is increased; but some other~     influential journals have the totally contrary results. We believe this diverse exhibition~     may be due to overlook the paracrine effect of decidual cells (representative of maternal~     environment), and in vitro cultured condition does not parallel to physiological condition.~      Our experiment has first obtained the qualification of Ethical Committee of our hospital and~     the permission of the examined patients. We first collect the serum sample of preeclampsia~     patient and analyze the IL-10 level by ELISA kit, and compared with normal control. Then we~     isolate trophoblast from pre-eclamptic women and normal control. These trophoblasts are~     further treated with (1) co-cultured with decidual cell line (2) Lipofectamine transfection~     with IL-10 (overexpression of IL-10) (3) signal interference ribonucleotide (siRNA) of IL-10~     (knockdown IL-10 function). Each groups (including trophoblast alone from patients or normal~     control) were subjected to the analysis of IL-10 mRNA amount by RT-PCR. Further experiments~     for these treated trophoblast are transwell migration assay and invasion assay, matrix~     metalloproteinase assay to determine the change of invasive capacity; and Fas ligand~     expression to determine the change of immunoregulation.~      Our effort is not only to determine the role of IL-10 in the pathogenesis of preeclampsia,~     but also the development of siRNA IL-10 may give a light in the treatment of preeclampsia.~   "
259369|NCT00154830|"~     Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood.~     Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common~     treated with hamstring lengthening. This surgery can alter mechanical property of lower limb~     and affected ability of generating force in hamstring, leading changes in functional~     activities. Therefore, the first aim of this study is to investigate the effects of hamstring~     lengthening on pelvis and hip control while performing functional activity, including level~     walking and sit-to-stand.~   "
259370|NCT00154817|"~     1. This is a phase II study of radiotherapy for patients with locally advanced HCC.~        2. Patients whose tumor(s) are not suitable for other local treatment, such as surgery,~          trans-arterial chemoembolization (TAE), ethanol injection, or radiofrequency ablation.~          will be enrolled.~        3. Radical radiotherapy will be started after pre-treatment evaluation. The total dose of~          RT will be 50Gy in 25 fractions to local tumor(s).~        4. Dynamic contrast enhanced MRI and serum samples will be done at the following time~          points to assess the change in tumor perfusion: (1) before the start of thalidomide~          treatment; (2) 2weeks after radiotherapy begins; and (3) 1 month after radiotherapy~          completes. DCEMRI will then be done every 3 months until disease progression.~        5. The study was designed to evaluate the response rate and tolerability of radical~          radiotherapy for locally advanced HCC. The sample size was determined by the expected~          incidence of grade 4 toxicity and response rate of radiotherapy for locally advanced~          HCC. Since the grade 4 toxicity of radiotherapy alone is 10%, the response rate is 60%~          we need at least 12 patients to evaluate for the treatment.~   "
259371|NCT00154804|"~     CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal~     cancer.~   "
259372|NCT00154791|"~     We plan to conduct a phase I/II clinical trial using biweekly gemcitabine, oxaliplatin, and~     48-hour infusion of high dose 5-FU/leucovorin to treat patients with advanced pancreatic~     adenocarcinoma. In the phase I part, the maximum tolerable dose of oxaliplatin in combination~     with biweekly gemcitabine 800 mg/m2 and 48-hour infusion of 5-FU 3000 mg/m2 and leucovorin~     300 mg/m2 will be determined. In the phase II part, the efficacy and safety of the biweekly~     chemotherapy with GOFL will be evaluated.~   "
259373|NCT00154778|"~     The purpose of this study is to evaluate the response rate of Paclitaxel combination~     chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer.~   "
259374|NCT00154765|"~     Therapeutic exercise is important to patients with knee osteoarthritis. Few studies reported~     the effect of therapeutic exercise in proprioception for these patients. The purposes of this~     study were to investigate the training effect of sling suspension exercises, as a~     proprioception-training tool, for patients with knee osteoarthritis and further, to build up~     an model of proprioception training.~   "
259375|NCT00154752|"~     Based on the neurophysiology, it is well known that sympathetic nerves control the~     ejaculatory function and bladder neck closure. In contrast, the parasympathetic nerves~     control penile erection and bladder wall contraction. Because of the difference in cultural~     background of the patients and training background of the physicians between Western and~     Oriental Countries, the Western people did not believe in the efficacy of wide pelvic~     lymphadenectomy. In the Oriental countries, due to the shortage of standardized facilities,~     treatment protocol, and manpower, the concurrent preoperative chemoradiation therapy (CCRT)~     of American style is currently not widely accepted. Therefore, the advantage and disadvantage~     of these two treatment modalities for advanced rectal cancers need be further clarified. In~     this project, we plan to randomly assign the patients into two groups: (1) concurrent~     preoperative chemoradiation therapy (CCRT) + conventional surgery group; (2) wide pelvic~     lymphadenectomy group. Thereafter, we plan to evaluate: (1) the anorectal function by~     anorectal manometry and colonic transit time using radioopaque markers; (2) the micturition~     function using urodynamic study; (3) the penile erection by RigiScan; and (4) the ejaculatory~     function by clinical interview of the patients. Moreover, the various clinicopathologic~     factors, including the depth of tumor invasion and the status of lymph node invasion, were~     recorded in detail according to the guidelines recommended by the Japanese Society of~     Coloproctology. Furthermore, we will evaluate the oncological results for these patients.~   "
259376|NCT00154739|"~     The purpose of this study is to evaluate the efficacy of gemcitabine/cisplatin versus~     gemcitabine/epirubicin in Stage IIIB/IV NSCLC in terms of response rate and overall survival.~   "
259377|NCT00154726|"~     The purpose of this study is to evaluate the efficacy,response rate,time to treatment~     failure,overall survival,toxicities of Paclitaxel-HDFL regimen in locally advanced/inoperable~     and recurrent/metastatic gastric cancers. To evaluate the resectability and relapse pattern~     after potentially curative resection of neoadjuvant Paclitaxel-HDFL regimen~   "
259378|NCT00154713|"~     The specific aims of this study are as follows:~        1. Primary endpoint: to evaluate the clinical responses of vaccinated patients.~        2. Secondary endpoint: to evaluate the safety of this treatment and the immune responses~          against CEA before and after the treatment~   "
259379|NCT00154700|"~     The primary objective of this study is to find out the response rate of twice weekly~     paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma~     patients who need palliative Chemotherapy.~   "
259380|NCT00154687|"~     The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced~     transitional cell carcinoma in terms of response rate and overall survival.~   "
259381|NCT00154674|"~     Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest~     patients for it improve brain recovery dramatically. However, traditional cooling devices and~     methods, most external cooling methods, include ice blanket, cooling helmet, or ice packing~     lower the body temperature slowly or inefficiently which make many emergency physicians~     hesitate to perform hypothermic resuscitation. To improve and promote the practice of~     hypothermia resuscitation, more efficient temperature control method is necessary. We conduct~     this clinical trial to evaluate the safety and feasibility of internal cooling catheter and~     temperature regulatory device, which is approved by FDA in neurologic ICU for temperature~     control, in the cardiac arrest patients.~   "
259382|NCT00154661|"~     we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1~     production in human glomerulonephritis.~   "
259383|NCT00154648|"~     This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic~     resonance angiography (CE-MRA) of the arteries.~   "
259384|NCT00154635|"~     A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of~     DCB-AD1 in Patients with Mild to Moderate Alzheimer’s Disease. Because of the limitation of~     the sample size we could expect but a positive trend of the efficacy unless the effect size~     of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical~     investigation such as a phase III study should be carried out in an even larger scale. We~     also should be able to obtain valuable experience on the adverse effect of prolonged~     (24-week) use of Fo-ti.~   "
259385|NCT00154622|"~     Work-related musculoskeletal disorders(MSD)are very common，which account for most of the~     occupational compensation in U.S.A。According to the epidemiological surveys，injured sites are~     frequent at low back，neck and shoulder and upper extremity。Although the MSD will not threaten~     the lives，they result in discomfort，some cost much and decrease the productivity。There was~     little study in our country to reveal the risk factors of medical utilization and disabling~     of MSD。Therefore，we do not have well-established strategy of the assessment and treatment for~     the workers who can not return to work。The purposes of this study are：1、To have sequential~     surveys to find the prevalence，incidence and possible risk factors of work-related MSD of~     employees in different industries and their medical utilization and disabled conditions。2、To~     find the victims of work-related MSD from clinics，assess their disablement and if they return~     to work and to find the factors those prevent them return to work。3、To develop individualized~     work hardening programs for the victims who can not return to wok after treatment。The program~     will be established according to their injuries and their work characteristics。~   "
259386|NCT00154609|"~     We, the investigators at National Taiwan University Hospital, have determined the therapeutic~     and toxic effects of the traditional herb on the ovariectomized Wistar rat.~      The final years will determine its effects on the therapy of women who are over 45 years old~     and postmenopausal with osteoporosis.~   "
259387|NCT00154596|"~     The purpose of this study is to investigate the infectious etiology of Kawasaki disease (KD);~     a prospective household and case control study for Kawasaki disease will be done. The~     investigators will enroll Kawasaki disease cases who have at least five of the following~     manifestations:~        1. fever for over 5 days~        2. neck lymphadenopathy~        3. lip fissure and/or strawberry tongue~        4. skin rash~        5. nonpurulent bulbar conjunctivitis~        6. palm/sole erythema and induration followed by desquamation, or coronary artery aneurysm~          with less than 5 of the above manifestations (atypical Kawasaki disease)~      The KD cases will receive virological (virus isolation from the blood, throat swabs and~     rectal swabs or stool, gene chip for possible viruses from stored RNA and DNA), bacterial~     (blood, throat swabs and stool: bacterial culture and stored strain for further toxin or~     superantigen detection), and serological (Mycoplasma pneumoniae, Chlamydiae pneumoniae, ASLO,~     HHV6, EV71, peptide library approach for auto-antibody or pathogen-related antibody, stored~     serum for further workup) workup. Stored DNA from the blood will also be performed.~   "
259388|NCT00154583|"~     Cervical cancer is the most frequent neoplasm and the third in mortality rate of the~     malignancies in women in the world. It results in about 200,000 women dying of cervical~     cancer each year worldwide. The available forms of treatment - surgery, radiation therapy,~     and chemotherapy - are all cytoreductive treatment modalities, so, in addition to killing~     cancerous cells, healthy cells are also destroyed in the process. Indeed, there is a need to~     decrease the incidence of cervical cancer and develop better forms for its treatment.~      Human papillomaviruses (HPV) have been consistently implicated in causing cervical cancer~     especially those high-risk types (HPV 16, 18, 31, 45) which have been strongly associated~     with cervical cancer. HPV 16 was found in more than 50% of cervical cancer tissues. So, the~     host immune response plays an important role in determining the regression of a cervical~     abnormality or persistence and progression to a malignancy via targeting HPV.~      The ideal cancer treatment should be able to eradicate systemic tumors at multiple sites in~     the body while having the specificity to discriminate between neoplastic and nonneoplastic~     cells. In this regard, antigen-specific cancer immunotherapy represents an attractive~     approach for cancer treatment. By cooperating with Dr. TC Wu at the Johns Hopkins Medical~     Institutes, the investigators have recently developed some E7-specific cancer vaccines of~     different strategies such as DNA, or replication-defective SINrep5 virus. They found that~     these E7-chimeric DNA vaccines are capable of preventing and treating the growth of murine~     model tumors expressing E7. These positive results from the preclinical murine models have~     encouraged the investigators to focus on the development of a cancer vaccine and~     immunotherapy and apply these vaccines to human subjects. However, it is very important to~     set up various E7-specific immunologic assays of human beings to evaluate the effects of a~     cancer vaccine or immunotherapy in future clinical trials. So the investigators would like to~     provide this proposal to address the development of HPV 16 E7-specific immunologic assays in~     human beings. There are two main goals in this study. First, the investigators would like to~     establish and compare the differences of HPV type 16 E7-specific immunologic responses~     between the normal population, people with HPV infection, patients with cervical~     intraepithelial neoplastic (CIN) lesions, and patients with cervical cancer. Second, they~     would like to correlate the disease severity of cervical cancer with the immunologic~     responses to HPV type 16 E7 antigen.~   "
259389|NCT00154570|"~     We hypothesize that gastric dysrhythmias may predispose the occurrence of gastroesophageal~     reflux.~   "
259390|NCT00154557|"~     Judo is one of the possible items in our country to win the first prize in Olympics. However,~     scientific research in this field is not enough to support the coaches to train the athletes.~     Series of research should be planned and executed to help the coaches and to promote the~     performance of our athletes. This is the first step of the serial research. The purposes of~     this study are: in the first year, to find the correlations between the~     physiological/psychological competitive abilities of the second/third year athletes and their~     performance/injury status. And, the physiological/ psychological competitive abilities of the~     first year athletes will be collected in the beginning of this year. And then, their~     performance/injury status will be followed through the whole year and to the end of the~     second year monthly. The purposes of this study in the second year are to find the causation~     of the physiological/ psychological competitive abilities in the first year with the~     performance/injury status in the second year.~      The subjects of this study are from 4 senior high schools in the north part of Taiwan which~     performed well in national judo competition in senior high schools in the past years. The~     study designs are both cross-sectional and prospective. In the part of the second/third year~     athletes, it is a cross-sectional design, and in the part of the first year athletes, it is a~     prospective design. The physiological status will be assessed with their general fitness and~     balance. The fitness test includes body composition, strength, power, endurance, agility,~     coordination, balance, flexibility, and cardiopulmonary capacity. The psychological~     competitive abilities will be assessed with a questionnaire. Injury and the possible causes~     will also be collected with a questionnaire monthly. Finally, the data will be analyzed with~     descriptive analysis, chi-square test, t-test and regression analysis to show their~     characteristics, correlations and causations.~   "
259391|NCT00154544|"~     Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. About~     6000-8000 people died of this cancer every year in Taiwan. Though regular sonographic~     examination can early detect small HCC and there are many therapeutic modalities for HCC, the~     therapeutic results remains unsatisfactory. Though Alpha-fetoprotein (AFP) and des-γ-carboxy~     prothrombin (DCP) are used as the tumor markers for diagnosis of HCCs, these two markers are~     not good enough for the early detection of small HCCs. To improve the survival, further~     investigations of the early diagnostic markers are still needed. In this current project, we~     applied the proteomic method to identify the HCC biomarkers.~   "
259443|NCT00153868|"~     This is a web-based pilot study to evaluate the association between the treatment of anemia~     with darbepoetin alfa (aranesp) and the clinical benefits in symptom palliation, improved~     functional status and quality of life in patients with cancer. The feasibility of web-based~     assessments and data capture will be evaluated.~   "
259392|NCT00154531|"~     Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. Though~     Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin(DCP) are used as the tumor markers for~     diagnosis of HCCs. Thus, these two markers are not good enough for the early detection of~     small HCCs. To improve the survival, further investigations of the early diagnostic markers~     are still needed.~      SELDI is a proteomic profiling techniques in biomarker discovery. Its approach has been~     successfully used to identify biomarkers of various cancers, such as prostate cancer, bladder~     cancer, ovarian cancer, lung cancer, colon cancer, breast cancer and pancreatic cancer.~      In this current project we will apply the SELDI technique to identify the HCC biomarkers.~     Sera samples from the HCC patients and relevant controls will be collected. We hope that we~     can find the new HCC biomarkers. If biomarkers of HCC are identified, this can be used to~     clinical application for the possible early detection of HCCs.~   "
259393|NCT00154518|"~     The purpose of this study is to test whether the two MMPs can be up-regulated during~     orthodontic treatment. Alveolar bone samples will be collected from partially impacted third~     molars after orthodontic uprighting for different periods of time in volunteers.~   "
259394|NCT00154505|"~     The effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17~     spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs.~     The LTS improved significantly the functional scoliotic spinal alignment in the frontal and~     sagittal planes regardless of the severity of scoliosis.~   "
259395|NCT00154492|"~     This trial is conducted in Asia and Europe. The trial is planned to investigate the~     effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active~     variceal bleeding.~   "
259396|NCT00154479|"~     Cervical cancer is the most frequent neoplasm of women in Taiwan and in the world. It~     influences about 2,700 women with about 1,000 women dying of cervical cancer each year and in~     Taiwan. Human papillomaviruses (HPV) have been consistently implicated in causing cervical~     cancer especially those high-risk types which have been strongly associated with cervical~     cancer. In recent years, there has been compelling evidence that infection with human~     papillomavirus (HPV) is a major etiologic factor in the development of cervical~     intraepithelial neoplasia (CIN) and cervical carcinoma.~      As in most virus-induced diseases, an adequate immune response is likely to play a key role~     in the clearance of HPV infections and HPV-related lesions. This assumption is born out by~     both epidemiological studies and animal models. Immune-compromised patients such as~     HIV-infected women, organ transplant recipients, and patients suffering from other forms of~     malignancies, are at a higher risk of developing CIN lesions and invasive cervical cancer.~     Moreover, several studies establish the existence of natural HPV E7-specific cytotoxic T~     lymphocyte (CTL) immunity in humans. Only a minority of women infected with oncogenic HPV~     types develop CIN or cervical cancer. Indeed, the majority of CIN lesions do not progress or~     even regress to normal cytology, indicating that other factors such as an inadequate immune~     function are necessary for the development of progressive CIN lesions and cervical carcinoma.~      Consequently, the HLA class I and II phenotypes may be correlated with an effective immune~     response against HPV-associated cervical lesions. Differences in the recognition of foreign~     antigens, such as those contributed by alleles at the HLA class I or II loci, might be~     proposed to affect the risk of developing cervical cancer.~      In the present proposal, the investigators would like to examine the HLA class I and II~     associations among Taiwanese women with cervical neoplasia. The purposes of this proposal~     are:~        1. to address the relationships between the HLA class I and II haplotype, HPV infection,~          and cervical cancer; and~        2. to elucidate the immunologic responses to HPV type 16 in different HLA class I and II~          haplotypes. It will help the investigators to identify which population of HLA genotypes~          is more susceptible to HPV infection and progresses to invasive cervical cancer. The~          results of this research will be very useful for the prevention and screening of~          cervical cancer in the future.~   "
259397|NCT00154466|"~     One emerging concept is that some form of injury or inflammation is a prerequisite for the~     success of circulating-cell participation in differentiated tissue structure and function.~     Once reperfusion is achieved in acute myocardial infarction, an intense inflammatory cascade~     is unleashed.~      The architecture of the left ventricle rearranges, leading to ventricular remodeling. The~     homing processinvolves stem cell migration to the sites of injury or ischemia, which~     provides an environment that is favorable to growth and function. This microenvironment is a~     stimulus for homing and differentiation of stem cells of the appropriate lineage. It~     increases vascular permeability and expression of adhesion proteins like integrin, along with~     homing receptors that facilitate the attachment, which is mediated by cell-to-cell contact~     and chemoattractant release from local tissue injury.The migratory capacity of stem cells~     might be dependent on natural growth factors such as vascular endothelial growth factor~     (VEGF) , stromal cell-derived factor-1 (SDF-1)and stem cell factor (SCF).The expression of~     VEGF ,SDF-1 and SCF is highly up-regulated in hypoxic tissue, supporting the hypothesis that~     these factors may represent homing signals crucial to the recruitment of circulating~     progenitor cells to assist the endogenous repair mechanisms in the infarcted tissue. This~     study will examine whether cardiac rehabilitation increases the concentration of stem cell~     factors released into the bloodstream and if these factors are correlated with the~     improvement of heart function.~   "
259398|NCT00154453|"~     Orbicularis oculi muscle is a key structure in the peri-orbital anatomy and is responsible~     for the major changes of aging in this area. Peri-orbital rejuvenation has been an issue of~     great interest in plastic surgery. We believe that understanding the age-related~     histomorphometric changes in orbicularis oculi muscle is important for improving the current~     rejuvenation techniques or developing the new ones. Nevertheless, a study focusing on this~     topic has never been performed before, simply because it is difficult and dangerous to~     perform needle biopsy on orbicularis oculi muscle.~   "
259399|NCT00154440|"~     The first objective of this study is to confirm the results of complete remission of~     low-grade gastric MALT lymphoma stage IE & II1E after H. pylori eradication on a larger~     number of patients (HELYX Part I). If there is no response to the antibiotic therapy, the~     role of radiotherapy on the course of gastric MALT lymphoma will be investigated as a~     consecutive therapeutic option for patients that are H. pylori- negative, t(11;18)-positive~     or failure candidates after eradication therapy. Furthermore, the method of radiation, and~     the radiation dose will be investigated and standardized. HELYX PART II is therefore a~     randomized equivalent study comparing the standard dose of 36Gy vs. a reduced dose of 25.2Gy~     locoregional. Additional molecular genetic analysis will be performed to try to understand~     pathogenetic mechanisms of lymphomagenesis.~   "
259400|NCT00154427|"~     This trial is conducted in Africa, Asia, Europe, South America and the United States of~     America (USA).~      The trial is planned to investigate the safety and efficacy of NovoSeven® in the management~     of post-operative bleeding in patients following cardiac surgery.~   "
259401|NCT00154414|"~     This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of~     treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese~     subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily~     in the evening. The trial is a multi-national trial with treatment concealed to participating~     subjects, investigators and the sponsor. Treatment allocation is random with equal chance of~     being assigned to each group.~   "
259402|NCT00154401|"~     This trial is conducted in Europe. The trial is designed to show the effect of treatment with~     liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2~     diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The~     trial is a multi-national trial with treatment concealed to participating subjects,~     investigators and the sponsor. Treatment allocation is random with equal chance of being~     assigned to each group.~   "
259403|NCT00154388|"~     Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening~     rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine~     kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that~     specific disease.~   "
259404|NCT00154375|"~     This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy~     with hydroxyurea monotherapy in patients with temozolomide resistant progressive~     glioblastoma.~   "
259405|NCT00154362|"~     Conduct disorder is a group of psychiatric symptoms that can include clinical characteristics~     of impulsivity and aggressive behavior. This study will investigate the efficacy a safety of~     oxcarbazepine in the treatment of adolescents with conduct disorder.~   "
259406|NCT00154349|"~     The objective of this study is to determine the efficacy and safety of imatinib mesylate in~     patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia~     (ALL).~   "
259407|NCT00154336|"~     Imatinib is a member of a new class of drugs known as signal transduction inhibitors. The~     purpose of this study is to evaluate the efficacy, safety and tolerability of imatinib in the~     treatment of rheumatoid arthritis in combination with methotrexate in patients who do not~     respond satisfactorily to standard treatment, e.g. methotrexate.~   "
259408|NCT00154323|"~     Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania,~     grandiose delusions, and suicidality. This study will investigate the efficacy a safety of~     oxcarbazepine in the treatment of patients with bipolar disorder type I or II.~   "
259409|NCT00154310|"~     The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen~     with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and~     well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium~     (EC-MPS) and cyclosporine microemulsion, but results in better renal function.~   "
259410|NCT00154297|"~     The purpose of this study is to evaluate if the delayed administration of everolimus could~     reduce the everolimus associated anti-proliferative complications (e.g. wound healing~     disorder) while maintaining efficacy, when compared to the immediate administration of~     everolimus in de novo renal transplant patients.~   "
259411|NCT00154284|"~     The purpose of this study is to evaluate the safety and efficacy of everolimus in combination~     with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney~     transplant recipients.~   "
259412|NCT00154271|"~     The study compares the efficacy of an aggressive versus a moderate initial antihypertensive~     regimen to reduce blood pressure in patients with Stage 2 hypertension. Additionally, the~     study examines the effects of blood pressure reduction on the levels of high sensitivity~     hsCRP. Although the main goal is to determine the overall effect of blood pressure reduction~     on hsCRP levels, analysis will also evaluate whether an aggressive antihypertensive regimen~     is more effective than a moderate one in reducing hsCRP levels.~   "
259413|NCT00154258|"~     Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long~     term treatment of clozapine in patients with treatment-resistant schizophrenia.~   "
259414|NCT00154245|"~     The study is a one-year prospective, open-label, safety and efficacy study. De novo renal~     transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and~     corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.~   "
259415|NCT00154232|"~     The aim of the study is to assess the short-term benefit of the combination of basiliximab,~     EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute~     rejection in a population of de novo renal transplant patients at potential high risk of DGF.~   "
259416|NCT00154219|"~     The purpose of this study is to evaluate the efficacy, tolerability, and safety of the~     investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip~     osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2~     selective nonsteroidal anti-inflammatory drugs [NSAIDs]).~   "
259417|NCT00154206|"~     The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with~     Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients.~     Safety and doses variations are also evaluated.~   "
259418|NCT00154193|"~     The main purpose of this study is to identify cyclosporine C2 levels during 12 months~     treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine~     blood samples, and retrospectively correlate C2 levels to outcome (renal function and~     incidence of acute rejections)~   "
259419|NCT00154180|"~     The study will examine the effects of estrogen and progesterone on the development of~     atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the~     menopausal transition.~   "
259420|NCT00154167|"~     The purpose of this study was:~        -  to determine if NV-101 accelerates recovery from numbness compared to placebo~        -  to evaluate safety of NV-101~   "
259421|NCT00154154|"~     The aim of this study is to evaluate the clinical and cost effectiveness of Dialectical~     Behavior Therapy (DBT) for chronically suicidal behavior in individuals diagnosed with~     borderline personality disorder (BPD). Recent investigations of DBT have yielded positive~     results and have challenged the widely held opinion that the prognosis for this condition is~     poor. This study will consist of a two-arm randomized controlled trial that will compare DBT~     with a General Psychiatric Management (GPM) condition consisting of a structured algorithmic~     medication intervention plus psychosocial counseling. One-hundred and eighty participants~     will be randomly assigned to either DBT or to the GPM condition. Clinical outcomes will be~     assessed by changes in: (1) parasuicidal behaviour; (2) treatment retention; (3) psychiatric~     symptomatology; (4) anger expression; (5) social functioning and (6) health status. Cost~     outcomes will include an analysis of health service utilization. Clinical and cost~     evaluations will occur at 4-month intervals over the course of the one-year treatment and~     over a two-year follow-up.~   "
259425|NCT00154102|"~     Drugs used against cancer work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together~     with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer~     ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known~     whether giving combination chemotherapy together with cetuximab is more effective than~     combination chemotherapy alone. This open-label trial investigates the effectiveness of~     cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil~     (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line~     setting, compared to the same chemotherapy alone on patient expressing the epidermal growth~     factor (EGF) receptor.~      Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to~     either receive the combination chemotherapy alone or with cetuximab (open-label study) and~     will then be treated until progression of the disease or unacceptable toxicity occur. Regular~     efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study~     together with regular safety assessments (e.g. safety labs). An independent Safety Board of~     experts will also monitor safety data.~      After participant discontinuation from the trial, regular updates on further treatments and~     survival status will be requested from the investigator.~      The entire study (from the first patient entering the study to the last collect of follow-up~     information) is 4-5 years long.~   "
259426|NCT00154089|"~     The primary objective of this study is to determine pilot safety and efficacy data for a~     topical formulation of EM-1421 applied to the cervix of patients with CIN 1, 2, or 3.~   "
259427|NCT00154076|"~     To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in~     Untreated Epilepsies~   "
259428|NCT00154063|"~     This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter,~     parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week~     single-blind placebo Safety Phase at the end of the study.~   "
259429|NCT00154050|"~     The study is designed to test the hypothesis that high dose candesartan treatment compared to~     quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent~     angioplasty in peripheral occlusive artery disease.~   "
259430|NCT00154037|"~     The study is designed to test the hypothesis in healthy subjects that candesartan and~     pioglitazone provide additional vascular relaxing or modulating effects in addition to their~     blood-pressure and blood glucose level reducing ability, respectively.~   "
259431|NCT00154024|"~     Vascular responses to angiotensin II and histamine are compared before and after 30 days of~     systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.~   "
259432|NCT00154011|"~     The study is designed to test the hypothesis in healthy subjects that the oral antidiabetic~     drug rosiglitazone provides additional vascular relaxing or modulating effects in addition to~     its blood glucose level reducing ability.~   "
259433|NCT00153998|"~     General Objectives:~        -  To test the feasibility of neoadjuvant treatment with cetuximab/chemotherapy followed by~          liver resection~        -  To determine the optimal combination (cetuximab/FOLFOX versus cetuximab/FOLFIRI) for~          further trials in preoperative chemotherapy~   "
259434|NCT00153985|"~     The purpose of this study is to determine if treatment with reduced-dose busulfex,~     fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor~     stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating~     blood counts. In addition the incidence and severity of side effects and of graft vs. host~     disease (GVHD) will be monitored.~   "
259435|NCT00153972|"~     The study is designed to measure the difference of dopamine turnover rate measured by~     Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with~     cabergoline and levodopa for 3 months.~      The study protocol includes an initial Fluoro-Dopa-PET scan before treatment and after three~     months double-blind treatment with cabergoline or levodopa.~      The hypothesis for this study is that the dopamine turnover rate is a more sensitive marker~     for the early diagnosis of Parkinson's disease compared to the standard Fluoro-Dopa-PET~     measuring only the Fluoro-Dopa uptake into the striatum.~      For the interventional part of the study, the hypothesis is that levodopa has larger effects~     on striatal dopamine turnover compared to dopamine agonists by providing more dopamine~     precursor. Enhancement of compensatory mechanisms for dopamine loss in early PD such as~     increased dopamine turnover could have several beneficial implications such as improvement or~     prolongation of symptomatic treatment responses, but might also produce therapeutic problems~     such as the development of levodopa-induced motor complications.~   "
259436|NCT00153959|"~     The aim of the study was to compare the effectiveness of acute psychiatric day care to~     conventional inpatient care within a cross-national multi-site randomised controlled trial.~   "
259437|NCT00153946|"~     Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a~     selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and~     have frequently been used for the treatment of acute brain infarction in Japan. The effect of~     combination therapy of these drugs, however, has not yet been elucidated. This study will~     test the safety and efficacy of the combination therapy with these agents in patients with~     acute non-cardioembolic and non-lacunar ischemic stroke.~   "
259438|NCT00153933|"~     The purpose if this study is to evaluate the side effects of the combination of bortezomib~     and Revlimid (CC-5013) in patients with relapsed and relapsed/refractory multiple myeloma.~   "
259439|NCT00153920|"~     Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple~     myeloma in patients who have received at least two prior therapies and have demonstrated~     disease progression on the last therapy. This study will determine if Velcade is effective in~     treating patients with multiple myeloma that have had no prior treatment for the disease. We~     will also use whole-genome scanning to identify drug response biomarkers in bone marrow~     samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and~     after treatment with Velcade.~   "
259440|NCT00153907|"~     The purpose of this study is to find the highest dose of capecitabine and oral navelbine that~     can be given without causing severe side effects, and to determine the safety, tolerability,~     and effects (good and bad) of capecitabine given with oral navelbine to patients with~     advanced breast cancer.~   "
259444|NCT00153855|"~     The purpose of the study is to detect structural brain changes using MRI and to correlate~     these findings with neurodevelopmental assessments in two-year old children previously~     enrolled in the NIH sponsored trial of inhaled Nitric Oxide (iNO) for the prevention of~     Chronic Lung Disease in preterm ventilated infants. It is hypothesized that this imaging will~     identify children with previously undiagnosed brain abnormalities and that the presence of~     structural abnormalities will be associated with deficits in motor, cognitive, and~     neurosensory development.~   "
259445|NCT00153842|"~     The primary aim is to evaluate the safety (Phase I components) of administering bexarotene~     (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin~     (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This~     study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral~     capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.~   "
259446|NCT00153829|"~     The purpose of the study is to determine whether the quality of life of patients with~     multiple chronic conditions cared for by primary care physicians will improve due to the~     introduction of a chronic illness management intervention.~   "
259447|NCT00153816|"~     Extensive experimental and observational data suggest that intake of calcium and of vitamin D~     exert protective effects on colorectal neoplasia. Building on their previous work, the~     investigators will investigate the chemopreventive effect of vitamin D in the large bowel, to~     study whether calcium with vitamin D is more effective than calcium alone, and to confirm~     their positive finding regarding calcium. The goal of this study is the development of~     chemopreventive combinations that will reduce risk of colorectal neoplasia sufficiently to~     permit the lengthening of surveillance intervals in most patients and to clarify important~     issues regarding the mechanisms of colorectal carcinogenesis and chemoprevention.~   "
259448|NCT00153803|"~     This is a national, randomized, web-based, double-blind study to determine whether erlotinib~     (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with~     inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic~     radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated~     agent following concurrent chemoradiation and prior to the emergence of drug resistance will~     prolong the progression-free survival by 40% (10 months → 14 months).~   "
259449|NCT00153790|"~     The primary aim is to examine whether the intake of PhosphoLEAN is effective in aiding a~     cohort of women in losing weight. Participants taking the supplement will have significantly~     greater improvement in study outcomes than those taking the placebo.~   "
259450|NCT00153777|"~     The purpose of the study is to determine the effect of cellulose sulfate on the transmission~     of HIV to women via vaginal intercourse. The secondary objectives are the effect on the~     transmission of gonorrhea and chlamydia via the same route.~      The study hypothesis is that there will be no effect.~   "
259451|NCT00153764|"~     The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete~     vitamin supplement with or without a combined omega-3 fatty acid supplement on selected~     clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus~     omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and~     C-reactive protein than those taking the other supplements.~   "
259452|NCT00153751|"~     To test the efficacy of herbal medicine in relieving symptoms and change of quality of life~     of patients with IBS.~   "
259453|NCT00153738|"~     This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol~     metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12~     weeks of supplementation.~   "
259454|NCT00153725|"~     The aim of the study is to investigate whether intravenous infusion of pantoprazole~     (Pantoloc) is effective in preventing recurrent bleeding in patients who present with acute~     ulcer bleeding and continue to use aspirin~   "
259455|NCT00153712|"~     The aim of this study is to study the natural history of the ulcer healing while on proton~     pump inhibitors (PPI) and the ulcer recurrence without acid suppression therapy of~     Non-steroidal Anti-inflammatory Drugs (NSAID), non-Helicobacter pylori (HP) bleeding ulcer~     patients.~   "
259456|NCT00153699|"~     We test the hypothesis whether topiramate narrows the angles which may render Asians more~     likely to suffer from acute angle closure glaucoma.~   "
259457|NCT00153686|"~     To compare the diagnostic yield of mesenteric angiogram with CE in patients with active~     obscure GIB.~   "
259458|NCT00153673|"~     The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor~     (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients.~   "
259459|NCT00153660|"~     The aim of this study is to compare celecoxib plus a PPI (esomeprazole) versus naproxen plus~     a PPI (esomeprazole) in preventing recurrent ulcer bleeding in arthritis patients with a~     history of ulcer bleeding who require concomitant ASA. We hypothesized that among patients~     with a history of ulcer bleeding who require concomitant ASA, celecoxib plus esomprazole~     would be superior to naproxen plus esomeprazole for the prevention of recurrent ulcer~     bleeding.~   "
259460|NCT00153647|"~     The primary aim of the study is to increase the success rate of cecal intubation in first~     colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims~     are to assess the procedure time, the terminal ileum intubation rate, the endoscopist~     satisfaction score, the patients' acceptance, the complication rate of these two procedures,~     and the intravenous sedative drugs used.~   "
259461|NCT00153634|"~     This was a randomized multi-center clinical trial to compare the microbiological efficacy,~     clinical efficacy, and safety of using standard versus biofilm susceptibility testing of P.~     aeruginosa sputum isolates to guide antibiotic selection for treatment of airway infection in~     clinically stable patients with CF.~   "
259462|NCT00153621|"~     Among adults with Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome~     (AIDS), Chronic Kidney Disease (CKD) has previously been reported to occur in approximately~     10% of children with HIV-infection. The frequency of CKD, its causes, and its natural history~     in children and adolescents with HIV-infection have not been systematically studied,~     particularly in the era of new anti-retroviral medications. The primary aim of this study is~     to determine the how common pediatric HIV-infected individuals have evidence of persistent~     proteinuria and CKD.~   "
259465|NCT00153582|"~     In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the~     leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet~     hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor~     (GM-CSF) 4 times bi-weekly, then monthly.~   "
259466|NCT00153569|"~     This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and~     KLH as immunological adjuvants in stage IV melanoma patients~   "
259467|NCT00153556|"~     Hib disease rates in rural Alaska before introduction of HIb conjugate vaccine were among the~     highest in the world. Since vaccine introduction, rates have fallen by 90% but the disease~     has not been eliminated. This study is designed to test one possible means of eliminating Hib~     carriage and thus to eliminate person to person transmission and invasive disease.~      The objective of this study is to evaluate the effectiveness of community-wide use of Hib~     conjugate vaccine for eliminating oropharyngeal Hib carriage in rural Alaska villages.~      Secondary objectives include:~        -  Determine risk factors for Hib OP carriage including demographic characteristics, and~          immunologic characteristics (antibody level and function). This will be accomplished~          through a case-control study described below.~        -  Measure antibody response to Hib conjugate vaccine among adults who have not previously~          received Hib vaccine. This will be accomplished through a cohort study of participating~          adults in the vaccine intervention communities.~   "
259468|NCT00153543|"~     To test the hypothesis that immune responses to 23-valent pneumococcal polysaccharide vaccine~     (PPV-23) could be improved in Alaska Native elders by immune priming with 7-valent~     pneumococcal conjugate vaccine (PCV-7), we assessed post-vaccination immune responses among~     Natives aged 55 years and older who were randomized into three arms: (1) one dose of PPV-23~     according to current state and ACIP recommendations; (2) one dose of PCV-7 followed two~     months later with a dose of PPV-23; and (3) one dose of PCV-7 followed six months later with~     a dose of PPV-23.~   "
259469|NCT00153530|"~     The aim of the study is to deliver primary systemic high-dose methotrexate (MTX) treatment to~     PCNSL patients and to define the role of whole brain irradiation (WBI) in primary therapy,~     i.e., to analyze whether patients who have undergone primary chemotherapy can postpone~     irradiation with its possible late sequelae until recurrence without incurring losses in~     progression-free and overall survival. This is studied here for the first time worldwide in a~     systematic, controlled and randomized manner. In this study, one arm with six cycles of~     high-dose MTX and subsequent irradiation (A1), which comes closest to a standard arm of~     primary therapy, at least according to the majority assessment, is compared to irradiation~     at recurrence with regard to time to progression and overall survival (A2). In primary~     therapy failure, it will also be analyzed to what extent salvage therapy with AraC is~     equivalent to irradiation as the standard arm with regard to time to progression and~     overall survival (arm B1 and B2).~   "
259470|NCT00153517|"~     The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment~     among women at low risk for preterm delivery. The objectives are:~        1. To examine the side effects and patient acceptability of oral versus intravaginal~          metronidazole.~        2. To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV~        3. To study the efficacy of oral and intravaginal metronidazole for the prevention of~          hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and~          maternal infectious morbidity.~   "
259471|NCT00153504|"~     The goal of the project is to examine the impact of providing housing for people living with~     HIV who are homeless or at imminent risk of homelessness on their HIV disease progression,~     risks of transmitting HIV, and medical care access and utilization.~   "
259472|NCT00153491|"~     This is a study of how well caregivers of children with malaria adhere to the recommended~     regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group~     receiving directly observed treatment in hospital or to a group treated at home by the~     routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic,~     pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and~     are used to evaluate drug adherence.~   "
259473|NCT00153478|"~     Project CHOICES Efficacy Study is a randomized controlled trial (RCT) designed to evaluate~     the clinical efficacy of a brief motivational intervention aimed at reducing alcohol-exposed~     pregnancies(AEP)in high-risk preconceptional women. The study is a multi-site collaborative~     study between the CDC and three universities. The hypothesis of the study is that a greater~     proportion of women will reduce thier risk of having an alcohol-exposed pregnancy after~     participating in the Information Plus Counseling (IPC) intervention than do those in the~     Information Only(IO) control group.~   "
259474|NCT00153465|"~     The study will examine the extent to which a group motivational intervention (ME) impacts~     retention, treatment compliance, and long-term outcomes in families with a history of, or~     high risk for, child maltreatment.~   "
259475|NCT00153452|"~     The goal of this project is to pilot-test an instrument that is designed to assess the~     relationship between persons who use controlling behavior with intimate partners, as a risk~     factor for perpetrating intimate partner violence, and workplace productivity. The goal is to~     validate a survey instrument that can be applied to other workplace settings to measure~     productivity losses associated with controlling and aggressive behavior, which will serve to~     inform the development of workplace interventions designed to prevent intimate partner~     violence (IPV). This pilot-test will include two components of a survey conducted with~     employees in a workplace setting: questions to determine one’s controlling behavior or~     propensity for violence in an intimate relationship, and questions designed to assess levels~     of productivity as measured by days missed from work (absenteeism) and days at work with~     diminished functional output (presenteeism). We expect productivity to decrease as one’s~     controlling behavior or propensity for perpetrating IPV increases. This study represents one~     of the first workplace surveys designed to measure workplace productivity as a function of~     controlling or violent behavior. Successful results would argue for a more wide-scale testing~     of the instrument, which could ultimately lead to the development of workplace interventions~     designed to prevent IPV.~   "
259476|NCT00153439|"~     The purpose of this study is to examine the efficacy of techniques to enhance participation~     in parenting programs.~   "
259551|NCT00152464|"~     The Early Prevention of Asthma in Atopic Children (EPAAC™) . 24 months study to evaluate the~     efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24~     months old children.~   "
259478|NCT00153413|"~     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,~     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors~     to prevent, delay and control cardiovascular and other chronic diseases.~   "
259479|NCT00153400|"~     The purpose of this trial is to provide low-income, under- or un-insured 40- to 64-year-old~     women with the knowledge, skills, and opportunities to improve diet, physical activity, and~     other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic~     diseases.~   "
259480|NCT00153387|"~     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,~     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors~     to prevent, delay and control cardiovascular and other chronic diseases.~   "
259481|NCT00153374|"~     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,~     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors~     to prevent, delay and control cardiovascular and other chronic diseases.~   "
259482|NCT00153361|"~     The purpose of this project is to test the efficacy of an HIV prevention behavioral~     intervention to reduce sexual risk for HIV infection among non-injection, substance-using men~     who have sex with men (SUMSM). The primary goal of the intervention is to reduce HIV~     transmission by reducing the incidence of unprotected anal sex while under the influence of~     alcohol and other drugs (AOD).~   "
259483|NCT00153348|"~     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,~     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors~     to prevent, delay and control cardiovascular and other chronic diseases.~   "
259484|NCT00153335|"~     This is a study to determine whether a computerized risk assessment and focused patient~     provider interaction can improve health outcomes in an employee population.~   "
259485|NCT00153322|"~     Community-based environmental approach to obesity prevention targeting first, second, and~     third grade students in Somerville, MA.~   "
259486|NCT00153309|"~     The purpose of this study is to evaluate the health and arthritis-specific benefits of~     participation in the Arthritis Foundation People with Arthritis Can Exercise program and to~     collect information to improve community-based dissemination of this program.~   "
259487|NCT00153296|"~     The purpose of this study was to determine whether antiepileptic drug carbamazepine is~     effective in the treatment of chronic moderate persistent and severe asthma.~   "
259488|NCT00153283|"~     The purpose of this study is to determine whether antiepileptic drug gabapentin is effective~     in the treatment of chronic asthma.~   "
259489|NCT00153270|"~     The purpose of this study is to determine whether antiepileptic drug sodium valproate is~     effective in the treatment of chronic asthma.~   "
259490|NCT00153257|"~     Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal~     approach could be improved when a polypropylene mesh is used as tissue support (1). However,~     non protected heavy-weight meshes were associated with a high rate of local complications~     such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to~     evaluate anatomical and functional results of an innovative low-weight polypropylene mesh~     protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in~     comparison by the standard anterior colporrhaphy.~      Study design, materials and methods This study involves 15 centres in French Private or~     Public Hospital. Patients will be randomly allocated to be operated by a standard anterior~     colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM~     (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%,~     pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective~     differentiation for a stable and long-term support. The mesh is coated with a hydrophilic~     film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating~     protects delicate pelvic viscera from the risk of acute inflammation during the healing’s~     inflammatory peak. Prolapse severity will be evaluated using the POP-Q system. In order to~     evaluate the patient’s quality of life, the validated PFDI and the PFIQ questionnaires will~     be used preoperatively and during follow-up (3), as well as a validated questionnaire on~     sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior~     colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each~     arm.~        1. Julian TM: The efficacy or Marlex mesh in the repair of severe, recurrent vaginal~          prolapse of the anterior mid-vaginal wall. Am J Obstet Gynecol 1996;175:1472-5.~        2. Milani R, Salvatore S, Soligo M, Pifarotti P, Meschia M, Cortese M. Functional and~          anatomical outcome of anterior and posterior vaginal prolapse repair with prolene mesh.~          Br J Obstet Gynaecol 2004;111:1-5.~        3. Barber MD et al. Psychometric evaluation of 2 comprehensive condition-specific quality~          of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol~          2001;185:1388-95.~   "
259491|NCT00153244|"~     The purpose of this study is to determine whether antiepileptic drug lamotrigine is effective~     in the treatment of chronic asthma.~   "
259492|NCT00153231|"~     Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and~     functional results of an innovative posterior tape in vaginal prolapse repair by vaginal~     route, in comparison to the sacrospinous suspension.~      Study design, materials and methods This study involves 5 centres in French Public Hospital.~     Patients will be randomly allocated to be operated by a sacrospinous suspension or by an~     posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the~     POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the~     PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated~     questionnaire on sexual problems. The difference on early post-operative pain should be 30%~     (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated~     number of patient is 40 in each arm.~   "
259493|NCT00153218|"~     The purpose of this study is to observe clinical outcomes of metastatic breast cancer~     patients whose tumors overexpress the Her2neu protein and are being treated with trastuzumab~     (Herceptin)either alone or combination with chemotherapy or hormonal therapy.~   "
259494|NCT00153205|"~     The purpose of this study is to determine how effective ward-based clinical pharmacists and~     computerized physician order entry systems are in reducing serious medication errors in~     pediatric inpatients.~   "
259512|NCT00152971|"~     To determine the comparative efficacy and safety of two different doses (75mg day 1 followed~     by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of~     dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day~     subcutaneous, in prevention of venous thromboembolism in patients with primary elective total~     knee replacement surgery~   "
259552|NCT00152451|"~     This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects~     with focal epilepsy.~   "
259679|NCT00150800|"~     This trial, evaluating the long-term safety and tolerability of brivaracetam will provide~     subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive~     treatment, the opportunity to receive open label brivaracetam treatment.~   "
259495|NCT00153192|"~     The purpose of this research study is to determine if Marinol alleviates pain in patients~     with chronic pain who are currently taking opioids.~      The study begins with a 2-hour initial visit followed by three 8-hour appointments at Brigham~     and Women's Hospital. At each 8-hour visit, patients receive a dose of medication and~     complete surveys relating to pain.~      During the first visit a brief examination and a few surveys about pain, quality of life, and~     medical history are given. The study doctor then determines if the participant continues to~     qualify for the study.~      If qualified for the study, patients receive a daily diary to record pain levels and pain~     medications; this will take about 5 minutes each day. After completion of the diary, patients~     begin the 8-hour visits.~      Patients visit the Pain Trials Center three times to receive study medication. After taking~     the study medication, participants remain in the clinic for 8 hours to complete hourly~     surveys about pain and pain relief.~      Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at~     home, and pain levels are recorded in a diary. Participants can change the dose of study drug~     to better control pain and side effects, after speaking with study staff. The study then~     concludes with a final 30-minute visit to summarize the participant's experience in the~     clinical trial.~   "
259496|NCT00153179|"~     This study will test the hypothesis that reduction in release of free fatty acids from~     adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal~     muscle glucose metabolism in subject with type 2 diabetes.~   "
259497|NCT00153166|"~     This trial will test the hypothesis that inflammation and insulin resistance contribute to~     reduced walking distance in subjects with intermittent claudication by impairing vascular~     reactivity and skeletal muscle metabolic function.~   "
259498|NCT00153153|"~     To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as~     compared to placebo in constipated patients.~   "
259499|NCT00153140|"~     The purpose of this study is to compare the safety and efficacy of extended~     polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.~   "
259500|NCT00153127|"~     The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG~     laxative versus placebo.~   "
259501|NCT00153114|"~     Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo~     therapy in pediatric patients with a history of constipation.~   "
259502|NCT00153101|"~     The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial~     (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and~     ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint~     of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for~     Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg~     daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this~     endpoint.~      Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor~     intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the~     study is to determine if treatment with telmisartan 80mg daily is superior to placebo~     reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I,~     stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant~     to Angiotension Converting Enzyme inhibitors.~   "
259503|NCT00153088|"~     The aim of this study is to compare the preventive effect of Telmisartan(Micardis) versus~     placebo control on the transition to overt nephropathy in patients with diabetic nephropathy~     manifesting microalbuminuria associated with type II diabetes, and to evaluate the efficacy~     and safety of Telmisart (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan,~     Telmisartan) for diabetic nephropathy patients.~   "
259504|NCT00153075|"~     The objective of this trial is to compare the total and regional deposition of aerosol in the~     lungs and oropharynx of patients with COPD at 3 different inspiratory flow rates following~     inhalation of Berodual delivered via the Respimat inhaler and Berodual? delivered via an~     HFA-metered dose inhaler.~   "
259505|NCT00153062|"~     The purpose of the trial is to determine if extended-release dipyridamole + aspirin~     [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis,~     Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to~     placebo, in the presence of background antihypertensive therapy, in prevention of a second~     stroke in patients who have recently suffered a stroke and therefore are at high risk of~     suffering another one.~   "
259506|NCT00153049|"~     1. To investigate the dose response of the combination therapy, Telmisartan and~          Hydrochlorothiazide for the Japanese patients with Essential Hypertension.~        2. To compare this dose response with that in the US study.~   "
259507|NCT00153036|"~     To collect additional confirmatory data on alteplase(rt-PA) in the European setting and to~     demonstrate that the treatment of patients between 3 and 4.30 hours of onset of symptoms of~     acute ischemic stroke with rt-PA compared to placebo-treated patients will result in an~     improved clinical outcome without increase of fatality rate.~   "
259508|NCT00153023|"~     The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in~     hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure~     beyond the target of 130/80 mmHg after one year of treatment.~      The primary objective of this study is to show that telmisartan 80 mg is at least as~     effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour~     proteinuria after one year of treatment.~   "
259509|NCT00153010|"~     Objectives: The objective of this study will be to determine the safety, tolerability, drug~     blood levels, and efficacy of each of three doses of NS 2330 (Tesofensine) given once daily~     compared with placebo in patients with mild to moderate Dementia of the Alzheimer's Type.~   "
259510|NCT00152997|"~     The objective of this trial is to investigate the efficacy and safety of pramipexole~     (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with~     primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese~     version of the RLS rating scale by the International Restless Legs Syndrome Study Group~     (IRLSSG) as a sub-study.~   "
259511|NCT00152984|"~     The primary objective of this study is to demonstrate the superiority of tiotropium compared~     to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma~   "
260582|NCT00138801|"~     The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the~     treatment of neuroborreliosis in a randomized controlled trial.~   "
259513|NCT00152958|"~     The primary objective is to assess sustained efficacy in patients who have responded to a 6~     month treatment with open-label pramipexole.~      Secondary objectives are the measurement of severity of the RLS, assessment of early~     withdrawal phenomena after termination of trial medication, augmentation under treatment,~     sleepiness, quality of life and subjective wellbeing, the physician's clinical assessment of~     symptom severity and improvement. Another secondary objective is safety and tolerability of~     treatment.~   "
259514|NCT00152945|"~     Lipoproteins are large complexes of molecules that transport lipids (primarily triglycerides~     and cholesterol) through the blood. The intestine has traditionally been viewed as a~     'passive' organ with respect to lipoprotein production, with intestinal lipoprotein~     production rates responding mainly to fat ingestion and absorption. The investigators have~     recently demonstrated in animal models that there is an overproduction of intestinal~     lipoproteins in both the fasted and the fed state. The investigators have also recently~     demonstrated that an elevation of plasma free fatty acids (FFAs) stimulates intestinal~     lipoprotein in hamsters. It is not known whether intestinal lipoprotein production can be~     acutely stimulated by an elevation of plasma FFAs in humans.~      Hypothesis: Intestinal lipoprotein particle production in humans can be stimulated by an~     acute elevation of plasma free fatty acids.~   "
259515|NCT00152932|"~     Impaired ocular blood flow is an important risk factor in the pathogenesis of primary open~     angle glaucoma (POAG). A few studies suggest that topical dorzolamide 2% may increase optic~     nerve perfusion. The objectives of this study are to learn the effects of dorzolamide on the~     retinal and optic nerve blood flow of glaucoma patients.~      The present study is a prospective, randomized, double-masked, crossover design study of~     newly diagnosed or already treated patients with early glaucoma.~      The investigators will check ocular blood flow parameters using the Canon Laser Blood~     Flowmeter (CLBF), used to evaluate retinal arteriole blood flow, and the Heidelberg retinal~     flowmeter (HRF), which measures blood flow through capillary beds in the retina and optic~     nerve head.~      Any demonstrated improvements to retinal and optic nerve blood flow with dorzolamide, will~     mean that the drug may protect against ischaemic nerve and retinal damage. Any documented~     improvement in flow could lead to a major change in the management of glaucoma patients as~     well as other retinal ischemic diseases such as diabetic retinopathy and central retinal vein~     occlusion.~   "
259516|NCT00152919|"~     Swelling of the prostate can occur during and after a brachytherapy. This swelling can cause~     urinary problems ranging from difficulty voiding to urinary retention. The purpose of this~     study is to investigate whether Mobicox started one week before brachytherapy and then~     continued afterwards is more effective in reducing the risk of needing a catheter than~     Mobicox given only afterwards.~   "
259517|NCT00152906|"~     A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary~     liver cancer) are candidates for surgery, but there are no curative treatment options for~     these patients. Their median survival time is 3 to 12 months. Stereotactic radiation (SRT)~     (highly conformal radiotherapy (CRT)) is a treatment option for these patients with~     unresectable liver cancer, now possible due to improvements in our ability to localize and~     immobilize liver tumors and an improved understanding of the partial liver volume tolerance~     to radiation. SRT should permit liver tumors to be treated to tumorcidal doses while sparing~     the uninvolved liver, decreasing the risk of treatment related normal tissue toxicity. With~     such conformal radiation, it is possible to deliver radiation in fewer fractions than~     traditionally required, which should be more convenient for patients. In this study, CRT will~     be delivered during shallow breathing or breath hold to minimize organ motion due to~     breathing, decreasing the volume of normal liver that must be irradiated.~   "
259518|NCT00152893|"~     In HIV patients, fasting insulin levels decrease with chromium supplementation. This study is~     to determine if chromium nicotinate supplementation at 400ug/day for 16 weeks will improve~     insulin resistance in HIV patients with metabolic abnormalities.~   "
259519|NCT00152880|"~     A large number hepatitis B surface antigen positive individuals are HBeAg negative with~     normal liver tests. Historically, such patients were thought to have suppressed viral~     replication and were considered to be at low risk for complications. With the use of more~     sensitive technology, physicians are now able to identify a group of patients who are HBeAg~     negative, have normal liver enzymes, and detectable HBV DNA. Some of these patients develop~     signs of liver inflammation and fibrosis on biopsy. We intend to investigate whether normal,~     programmed cell death (apoptosis) plays a role in causing the silent liver injury in this~     group of patients. In other words the purpose of this study is to see whether apoptosis may~     be responsible for the silent liver death and injury that occurs in these so called inactive~     carriers who are HBeAg negative, have normal serum ALT values and HBV DNA > 10,000 copies/mL.~     In this study the liver biopsies would be routinely collected in the clinic and investigated~     for the evidence of inflammation and fibrosis, and special testing would be performed to~     detect for evidence of apoptosis. Around 30 patients from UHN would be participating in this~     study. This study will test the hypothesis that subjects who are HBeAg negative, have normal~     ALT and have HBV DNA ≥10,000 copies/mL will demonstrate an increased rate of apoptosis in~     liver tissue compared to healthy age-matched controls. If this hypothesis is confirmed, it~     will imply that the previous assumption that this group of patients has inactive disease is~     false and would implicate apoptosis as an important mechanism responsible for causing liver~     damage. If apoptotic activity is indeed elevated, further study of these pathways could~     potentially yield therapeutic interventions to inhibit apoptosis.~   "
259530|NCT00152737|"~     The whole study is divided in 4 parallel protocols. The first protocol estimates the~     reliability of the technique through test-retest recordings. The second protocol aims to~     prove that exercise Tcpo2 is efficient to estimate the benefit of proximal revascularisation~     on proximal and distal ischemia in patients suffering stage two lower extremity arterial~     disease. The third protocol aims at estimating with exercise tcpo2 the eventual apparison of~     proximal ischemia after aorto-bi-femoral bypasses. The last protocol is a transversal study~     of patients with aorto-bi-femoral bypasses aiming to analyse the presence of proximal and~     distal symptoms and ischemia.~      The hypothesis for protocol 2 is that TcpO2 at exercise is significantly improved after~     surgery at the aortic and primary iliac artery. The hypothesis for protocols 3 and 4 relates~     on the hypothesis that a significant number of patients benefiting aorto-bi-femoral bypass~     suffer isolated proximal pain/ischemia after surgery.~      Amendement to the project has been recently validated to study the neurologic and bone~     complication of chronic vascular ischemia~   "
259520|NCT00152867|"~     Background: Dexamethasone is a steroid, which is often given into the vein before~     chemotherapy to help control acute nausea and vomiting. It can also be given as an oral~     tablet for patients to take for the two days following chemotherapy to help minimise delayed~     nausea and vomiting. In chemotherapy regimens that cause high rates of nausea and vomiting,~     the use of dexamethasone is well proven. However, in chemotherapy regimens that generally~     cause only minimal to moderate rates of nausea and vomiting, the value of oral dexamethasone~     in the 48-hour period after chemotherapy is not well proven, although it is often prescribed.~     While dexamethasone does decrease nausea, it causes additional side-effects such as insomnia,~     indigestion, anxiety and mood changes. While patients with less vomiting and nausea are~     expected to have better quality of life (QOL), for patients with minimal nausea or vomiting,~     their QOL might be more affected by the side effects of the dexamethasone treatment than by~     the nausea.~      Study Design: The study will be performed in patients who will be receiving first line~     chemotherapy treatment with a moderate risk of nausea/vomiting. Anti-nausea therapy for acute~     nausea/vomiting will be standardised and all patients will receive non-steroidal medication~     for delayed nausea control. Each patient will be randomly allocated to receive either oral~     dexamethasone or an identical appearing placebo tablet for two days after chemotherapy for~     the first cycle of chemotherapy, and then crossed over to the other treatment for the second~     cycle. Patients will complete QOL assessments, dexamethasone symptom and nausea and vomiting~     questionnaires, as well as nausea/vomiting diaries. This will enable the researchers to~     determine the effect of dexamethasone on nausea and vomiting and the impact of both the side~     effects of dexamethasone, and of nausea and vomiting, on QOL.~      Objectives: The primary objectives are to determine patient preference for dexamethasone or~     placebo, and to compare changes in QOL after chemotherapy in patients who receive~     dexamethasone with those who receive placebo. The secondary objectives are: (1) to compare~     complete protection from delayed vomiting and severity of nausea; (2) to compare differences~     in the impact of nausea and vomiting on QOL, and (3) to compare differences in symptoms that~     have been associated with dexamethasone (insomnia, anxiety, agitation, mood, etc.) between~     patients receiving dexamethasone and those receiving placebo.~      Significance: This study will provide data to evaluate whether the benefits of dexamethasone~     for delayed nausea and vomiting outweigh potential side effects in patients receiving~     chemotherapy with a moderate risk of causing nausea and vomiting. This addresses a problem~     that is important to a majority of patients receiving anticancer chemotherapy. If overall QOL~     is improved on dexamethasone, then it should be prescribed more frequently, but if QOL is~     reduced on dexamethasone, and patients prefer the placebo, then its use as an anti-nausea~     medication for delayed nausea after moderately nauseating chemotherapy should be limited to~     patients with poor initial control of nausea/vomiting.~   "
259521|NCT00152854|"~     Many patients with cancer pain have pain not fully controlled on opioids (eg. morphine). The~     addition of acetaminophen (Tylenol) to opioids in a small study in cancer patients~     demonstrated better pain control without an increase in side effects. This study will~     determine if regular acetaminophen improves pain control when added to strong opioids in~     patients with cancer pain.~   "
259522|NCT00152841|"~     Hypothesis:In patients with ulcerative colitis and Crohn's disease diagnosed with mild or~     moderate anaemia:~        1. iron supplementation will increase disease activity and oxidative stress~        2. the addition of antioxidant vitamin will reduce this detrimental effect~   "
259523|NCT00152828|"~     This is a phase I/II study to evaluate the safety and toxicity of celecoxib in combination~     with standard concurrent cisplatin and radiotherapy in women with locally advanced cervix~     cancer. In addition, we aim to determine the effect of celecoxib (Celebrex) on tumour~     oxygenation, interstitial fluid pressure, COX-2 levels, prostaglandin E2 levels, angiogenesis~     and apoptosis.~   "
259524|NCT00152815|"~     The purpose of this study is to evaluate the effect of a one-year nutritional intervention~     with either betaine or vitamin E supplementation, or a weight reducing diet and exercise~     program on liver steatosis and steatohepatitis.~   "
259525|NCT00152802|"~     The trial will compare a group of patients whose immune system is primed with the~     pneumococcal conjugate vaccine and then given a boost with polysaccharide vaccine~     (prime-boost strategy) vs. a group vaccinated with the standard 23-valent polysaccharide~     vaccine alone. It is hypothesized that the conjugate vaccine priming will provide an enhanced~     response in these immunosuppressed individuals who may respond poorly to standard~     vaccination.~   "
259526|NCT00152789|"~     This study is based on previous observation that, in men with localized prostate cancer,~     non-cancerous prostate tissue is hypoxic, and on the known contribution of hypoxia to the~     progression of cancer. Patients undergoing diagnostic prostate biopsy with serum prostate~     specific antigen (PSA) less than 10ng/ml and who have given informed consent will have oxygen~     measurements of the prostate and peri-prostatic tissue taken with the Eppendorf electrode at~     the time of biopsy. The oxygenation of normal prostate tissue will be compared to that of~     cancerous prostate tissue. In men with negative biopsies, the prostate tissue oxygen~     measurements will be compared with the peri-prostatic tissue oxygen measurements.~   "
259527|NCT00152776|"~     The purpose of this study is to determine whether ovaria comp. is effective in relieving~     climacteric symptoms.~   "
259528|NCT00152763|"~     About 30% of patients survive a cardiac arrest, and the majority of these receive an~     implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD).~     While ICD therapy offers survival benefit over drug therapy, there remain significant quality~     of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD~     shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating~     ICD therapy. The aims of the current study are:~        1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with~          receiving an ICD for secondary prevention of SCD,~        2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e.,~          anti-tachycardia pace terminations and shocks); and~        3. to explore if the psychosocial intervention results in less need for appropriate ICD~          therapies.~   "
259529|NCT00152750|"~     In the present study, we examine the question “Will day-time aggression in children improve~     when their night-time sleep is treated with pharmacological intervention (i.e. clonidine)?”~     There is considerable anecdotal evidence that clonidine may provide an effective alternative~     to neuroleptics for treating aggression in children -- first by improving the overall quality~     of their sleep, and second by providing a safer and more readily tolerated medication with~     fewer side-effects and a greater probability of long-term compliance. This study uses a~     double blind placebo controlled design to gather scientific evidence that will help elucidate~     the mechanisms underlying this treatment effect and will help clarify the relationship~     between sleep disorders and aggression in children. Our results are expected to help~     physicians make informed treatment decisions regarding the use of clonidine to improve the~     quality of sleep and possibly treat problems with aggression in their pediatric patients~   "
259531|NCT00152724|"~     Microvascular dysfunctions are critical events in several diseases including diabetes. This~     study will develop a methodology for microvascular investigation in human skin. The purpose~     of the study is to investigate the physiological response of the cutaneous microcirculation~     to physical, thermal, mechanical or chemical stimulations.~   "
259532|NCT00152711|"~     This study aims to evaluate the impact of nasal continuous positive airway pressure (nCPAP)~     treatment on liver enzymes in patients with sleep apnea syndrome and nonalcoholic~     steatohepatitis. Using a cross over design, the evolution of liver enzymes will be evaluated~     in 40 patients during a consecutive period of 6 weeks, with and without nCPAP treatment.~   "
259680|NCT00150787|"~     A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse~     events reporting, physical and neurological examination and vital signs~   "
259533|NCT00152698|"~     The retinal vasculature is morphologically and functionally related to the cerebral vessels~     due to its common origin from the internal carotid artery. A recent study demonstrated that~     endothelium-dependent vasodilation of the retinal vasculature is impaired in patients with~     essential hypertension, which is a strong risk factor for stroke. Furthermore, AT1-receptor~     blockade was demonstrated to improve retinal endothelium-dependent vasodilation in these~     hypertensive patients. Hypercholesterolemia is also a risk factor for ischemic stroke and~     impairment of endothelial function has been observed in various vascular beds in~     hypercholesterolemic patients, including the coronary and the forearm vasculature. Whether~     endothelial function of the retinal vasculature is impaired in patients with~     hypercholesterolemia has not yet been investigated. In patients with stroke, AT1-receptor~     blockade and angiotensin-converting enzyme inhibition have beneficial effects on clinical~     outcome. Alterations of endothelial function of the cerebral vasculature might be one~     pathogenetic factor for the beneficial clinical outcome. To further address this issue, the~     present study was designed to test the hypothesis that endothelium-dependent vasodilation of~     the retinal vasculature is impaired in hypercholesterolemic patients and that endothelial~     function can be improved by AT1-receptor blockade.~   "
259534|NCT00152685|"~     Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery~     after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water~     after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic~     serum albumin is able to reduce intracranial pressure for several days after severe head~     injury and thus reduce mortality and morbidity.~   "
259535|NCT00152672|"~     This prospective randomized cross over study aims to compare nCPAP with mandibular~     advancement device for the treatment of sleep apnea syndrome.The effectiveness of nCPAP and~     oral appliance on apnea-hypopnea index, daytime sleepiness and quality of life will be~     compared in 60 patients.~   "
259536|NCT00152659|"~     The purpose of this study is to study how disease processes like tumors or epilepsy spread in~     the brain.~   "
259537|NCT00152646|"~     The aim of the study is to show the implication of platelets in vasodilation using in vivo~     and in vitro analysis and to compare the effects of placebo, aspirin and Clopidogrel in this~     interaction platelets/vessels.~      The effects of 7 days of each treatment will be compared in healthy subjects and patients~     with arteriopathy.~   "
259538|NCT00152633|"~     Essential hypertension is commonly associated with impaired endothelial function. The retinal~     vasculature is morphologically and functionally related to the cerebral vessels because of~     the common origin from the internal carotid artery. A recent study in hypertensive patients~     demonstrated that endothelial function of the retinal vasculature is impaired in hypertensive~     patients and that it can be restored by treatment with an AT1-receptor antagonist. It is not~     clear whether this effect is due to blood pressure lowering or whether this is a blood~     pressure independent effect. The present randomized, double blind study with a cross over~     design addresses this issue by comparing the effects of losartan and metoprolol on retinal~     endothelial function in patients with essential hypertension.~   "
259539|NCT00152620|"~     The aim of this therapeutic trial is to compare the response of subjects with active IBD to~     daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone.~   "
259540|NCT00152607|"~     The purpose of this study is to:~      determine the safety of donor right hepatic lobectomy as a procedure to provide a liver graft~     for living donor liver transplantation.~      study the regeneration of liver tissue by volumetric testing for both donor and recipient.~      assess if graft and patient survival with living donor transplantation is comparable to that~     of cadaveric donor transplantation.~   "
259541|NCT00152594|"~     The purpose of the study is to determine whether voriconazole is as effective as antifungal~     prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML).~      Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until~     day 21 after the start of induction chemotherapy.~   "
259542|NCT00152581|"~     Open-label, single centre study evaluating efficacy and viral kinetics of combination~     PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral~     clearance demonstrated between 4 – 12 weeks, then randomised to further continued combination~     treatment for one of three defined durations. Followed-up for 24 weeks after treatment~     cessation.~      Objectives:~        1. To determine the necessary duration of combination treatment with Pegylated-Interferon~          alfa2a (PEGASYS) & Ribavirin in Patients infected with genotype 1, in order to achieve~          viral clearance~        2. To identify host factors, which are associated with different patterns of virological~          response to combination treatment (fast responder, slow responder, non-responder). On~          this basis, to identify possible predictors for the duration of antiviral treatment.~   "
259543|NCT00152568|"~     The purpose of this research is to evaluate the effectiveness of checking car seats during~     pediatric well-child visits on the use and properness of use of car seats for children 0-8~     years. We are following up with families when they return for the next pediatric check up to~     see if they are appropriately using car seats for their children.~   "
259544|NCT00152555|"~     The purpose of this study is to see if there is an improvement in patient's quality of life,~     pain, and fatigue after undergoing a supervised exercise program. If improvement is found,~     this will help guide standard of care with lupus patients with a focus on exercise for~     improvement of endurance, pain and overall health.~   "
259545|NCT00152542|"~     Our previous data demonstrated that premature infants treated with inhaled nitric oxide at~     birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to~     determine whether this benefit continues through school age.~   "
259546|NCT00152529|"~     The purpose of this study is to adapt depression prevention interventions of proven benefit~     to the primary care setting in a manner that would be acceptable and potentially available to~     young adults in the community.~   "
259547|NCT00152516|"~     To allow pediatric patients with partial onset seizures an opportunity to receive (as~     follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment)~     open-label levetiracetam treatment, continue studying cognition and behavior in children, and~     continue collection of safety/efficacy data.~   "
259548|NCT00152503|"~     This trial will evaluate the efficacy and safety of ucb 44212 as add-on therapy in subjects~     with focal epilepsy.~   "
259553|NCT00152438|"~     The primary purpose of this study is to determine the effects of a full dose (300 mg at hs)~     of oral micronized progesterone (OMP) on vasomotor symptoms [VMS] (hot flushes/night sweats),~     on forearm blood flow and on lipid levels and blood pressure in menopausal women without~     cardiovascular disease and with moderate to severe VMS.~      The hypotheses are that progesterone will improve hot flushes, increase endothelium-dependent~     forearm blood flow and will decrease blood pressure without change in lipid levels.~   "
259554|NCT00152425|"~     A 26 week maintenance study of CDP870 in Crohn's disease~   "
259555|NCT00152412|"~     4 week open study to evaluate the safety of levocetirizine in young children (2 - 6 years)~     suffering from allergic rhinitis. As secondary objective, this study will assess the efficacy~     of the treatment by means of the T4SS (Total 4 symptoms scores of allergic rhinitis) and each~     of the 4 individual rhinitis symptom scores~   "
259556|NCT00152399|"~     To assess the efficacy and safety of the early administration of somatostatin in infusion~     during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with~     suspicion of PUB.~   "
259557|NCT00152386|"~     Patients will be assigned to one of three treatment groups. Study medication is administered~     over a 52 week study duration.~   "
259558|NCT00152373|"~     clinical efficacy and safety of Levetiracetam as add-on therapy in adult Chinese subjects~     with partial seizures.~   "
259559|NCT00152360|"~     The purpose of this study is to determine the effect of using the weight loss medication~     Xenical (generic name - orlistat) on weight loss and change in heart disease risk factors in~     patients of the Healthy Heart Program Lipid Clinic at St. Paul's Hospital over a three month~     period. Xenical works by blocking the body's absorption of dietary fat in the gut, allowing~     it to pass through to be excreted, therefore reducing the intake of fat and calories. This is~     a pilot study supported by Hoffmann-La Roche Limited which produces Xenical. The aim is to~     investigate whether weight loss will also result in reductions in heart disease risk factors~     that may allow for less of a need for medications controlling lipid levels, hypertension and~     plasma glucose.~   "
259560|NCT00152347|"~     The purpose of this study is to continue the work from the previous review study and~     determine the effectiveness of Botox in treating patients with idiopathic clubfoot by~     comparing outcomes of subjects treated with manipulation and casting plus Botox (treatment~     group) to those treated with manipulation and casting plus placebo (control group).~      The null hypothesis is that manipulation and casting plus Botox is not an effective treatment~     for idiopathic clubfoot. The alternate hypothesis is that manipulation and casting plus Botox~     is an effective treatment for idiopathic clubfoot.~   "
259561|NCT00152334|"~     The purpose of this study was to determine the efficacy of adding Botox injection to serial~     manipulations and castings in patients with clubfoot. The study hypothesis was that the use~     of Botox in the setting of serial manipulations and castings is an effective treatment for~     clubfoot.~   "
259562|NCT00152321|"~     An evidence-based quality improvement intervention will overcome multiple barriers to best~     practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk~     patients. The intervention will be directed at patients (education and counseling) and their~     primary care physicians (reminders and opinion leader generated and endorsed single page~     guidelines)~   "
259563|NCT00152308|"~     The purpose of the study is to evaluate the effectively of coating of coronary stents with~     two different doses of rapamycin for the prevention of coronary vessel re-blockage~   "
259564|NCT00152295|"~     The objective of this study is to determine the long-term safety of asoprisnil 10 mg when~     administered to postmenopausal women with Premarin® 0.625 mg~   "
259565|NCT00152282|"~     The objective of this study is to determine the safety and effectiveness of 3 asoprisnil~     doses when administered to postmenopausal women with Premarin® 0.625 mg.~   "
259566|NCT00152269|"~     The objective of this study is to determine the safety and effectiveness of asoprisnil in~     symptomatic women with abnormal uterine bleeding associated with uterine fibroids.~   "
259567|NCT00152256|"~     The objective of this study is to determine the safety and efficacy effects of two doses of~     asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to~     premenopausal subjects with symptomatic uterine leiomyomata.~   "
259568|NCT00152243|"~     This is a controlled study designed to evaluate the efficacy of UFT on survival compared with~     surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery~     followed by UFT within 6 weeks after curative resection. To assess treatment response, data~     on recurrence and survival will be collected for 5 years after enrollment of the last~     patient. To evaluate safety, data on adverse events will be collected for 16 months after the~     start of treatment.~   "
259569|NCT00152230|"~     This is a controlled study designed to compare relapse-free survival and overall survival in~     patients receiving UFT with those in patients receiving surgery alone. Patients will be~     randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative~     resection. To assess treatment efficacy, data on recurrence and survival will be collected~     for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events~     will be collected for 12 months after the start of treatment.Evaluations will be separately~     done for colon cancer and rectal cancer.~   "
259570|NCT00152217|"~     This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with~     surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery~     followed by treatment with TS-1 within 45 days after curative resection (curability A or B).~     To assess the efficacy, data on recurrence and survival will be collected from the time of~     enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be~     collected from the time of enrollment until 1 year after surgery.~   "
259594|NCT00151905|"~     Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes~     the use of inhaled medications which are usually first mixed with a standard salt solution.~     Inhalation of a more concentrated salt solution (hypertonic saline) has been successfully~     used to treat other types of lung disease in children and adults. The purpose of this study~     is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more~     quickly.~   "
259716|NCT00150306|"~     To evaluate the safety and efficacy of sertraline compared to placebo in children and~     adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder.~   "
259571|NCT00152204|"~     The safety and efficacy of Intermittent Preventive Treatment for malaria and anaemia control~     in Infants (IPTi) have already been documented in Southern Tanzania, affording an opportunity~     to gain operational experience in developing a strategy for the longer-term implementation of~     IPTi. Working in conjunction with national and district-based health authorities, a strategy~     will be developed to make IPTi available through routine health services and an effectiveness~     evaluation conducted. This will be based on the comparison of process and outcome indicators~     in areas with and without IPTi. Information on safety will be consolidated and the effect of~     IPTi on the rate of development of drug resistance explored. The acceptability and costs of~     implementing IPTi will be monitored and combined with assessments of effectiveness (in terms~     of morbidity and mortality) to assess the cost-effectiveness of IPTi.~   "
259572|NCT00152191|"~     This is a randomized controlled study designed to evaluate the relapse-free survival of the~     UFT group compared with the CMF group. Patients will be randomly assigned to receive either~     CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on~     recurrence, and survival will be collected for up to 10 years after enrollment of the final~     patient. To assess safety, data on adverse events will be collected for 2 years after the~     start of treatment. Patients'quality of life will be assessed by means of a questionnaire.~   "
259573|NCT00152178|"~     This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared~     with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM~     within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival~     will be collected for 5 years after surgery. To evaluate the safety, data on adverse events~     will be collected during treatment. Patients'quality of life will be assessed by means of a~     questionnaire.~   "
259574|NCT00152165|"~     Twelve subjects will be sought for this study. Six subjects will receive the DYNESYS system~     and six subjects will receive a posterior lumbar interbody fusion (PLIF) with the Silhouette~     device. All subjects will already be participating in the DYNESYS multi-center study (under~     IRB #4884) and will have been randomized to either group. Five tantalum beads will be~     inserted into each vertebra associated with the DYNESYS or fusion surgery. Subjects will be~     followed in conjunction with the multi-center follow-up schedule and will have RSA exams at~     the following time points after surgery: 3, 6, 12, 18, and 24 months. Standing neutral,~     flexion, extension, and lateral bending films will be collected at each time point and the~     amount of motion in each direction of the marked vertebrae will be measured. The time~     points have been selected based on their clinical relevance for comparison against the~     standard of care, which is the fusion procedure. Depending on the initial tension of the~     annular fibers, it is possible the DYNESYS will exhibit more motion with time. The time~     points are important to track the potential changes.~   "
259575|NCT00152152|"~     Radiostereometric Analysis (RSA) is a new imaging technique used to measure motions in the~     spine. It provides more accurate measurements that could help in diagnosing problems in the~     spine earlier than standard xray techniques.~   "
259576|NCT00152139|"~     Childhood leukemias which cannot be cured by chemotherapy alone may be effectively treated by~     allogeneic bone marrow transplantation. Moreover, for patients with chronic myelogenous~     leukemia (CML), allogeneic hematopoietic stem cell transplantation (HSCT) is the only proven~     curative modality of treatment. Patients who have received hematopoietic stem cells from an~     HLA matched sibling donor have proven to be less at risk for disease relapse and regimen~     related toxicity. However, about 70% of patients in need of HSCT do not have an HLA matched~     sibling donor. This necessitates the search for alternative donors, which may increase the~     risk of a poor outcome.~      The nature of the hematopoietic stem cell graft has been implicated as a primary factor~     determining these outcomes. The standard stem cell graft has been unmanipulated bone marrow,~     but recently several advantages of T-lymphocyte depleted bone marrow and mobilized peripheral~     blood progenitor cells (PBPC) have been demonstrated. However, T-cell depletion may increase~     the risk of infectious complications and leukemic recurrence while an unmanipulated stem cell~     graft may increase the risk of graft vs. host disease (GVHD). A key element in long range~     strategies in improving outcomes for patients undergoing matched unrelated donor (MUD) HSCT~     is to provide the optimal graft.~      The primary objective of this clinical trial is to estimate the incidence of acute GVHD in~     pediatric patients with hematologic malignancies who receive HSCT with an unmanipulated~     marrow graft. The results of this study can be used as the foundation for future trials~     related to engineering unrelated donor graft.~   "
259577|NCT00152126|"~     Studies have provided evidence that residual microscopic malignant cells in autologous bone~     marrow or blood stem cell grafts can contribute to posttransplant relapse. Researchers are~     currently exploring different methods in an attempt to purify or purge the stem cell~     product to minimize the risk of tumor contamination.~      The CD133+ antigen is a protein contained on or expressed on numerous cells in the human~     body including specific hematopoietic progenitor (blood forming) cells. However, this antigen~     is not expressed on certain cancer cells including neuroblastoma. A technique using the~     investigational CliniMACS cell sorting device has been developed in an effort to filter out~     only those stem cells that express this CD133+ antigen in order to infuse a hematopoietic~     stem cell product with no tumor contamination potential.~      The primary objective of this study is to establish safety of treating patients with a high~     dose chemotherapy regimen of Busulfan and Melphalan followed by autologous CD133+~     hematopoietic stem cell support. Transplants recipients are expected to achieve engraftment~     as defined by an absolute neutrophil count of greater than or equal to 500/mm3 for three~     consecutive days by day 42-post infusion. Thus, safety of the treatment plan will be~     evaluated in terms of failure to engraft by this specific time period.~   "
259595|NCT00151892|"~     Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of~     the bowel becomes red and swollen. Over time, patients with this disease may experience acute~     episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without~     disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is~     an experimental drug designed to gradually release 5-ASA into the areas of large bowel~     associated with ulcerative colitis. This study will test the safety and efficacy of~     mesalazine in keeping ulcerative colitis in remission.~   "
259717|NCT00150293|"~     To determine long-term safety and efficacy of pregabalin in patients with partial seizures.~   "
260583|NCT00138788|"~     This is a comparison of radiotherapy fractionation schemes for brain metastasis.~   "
259578|NCT00152113|"~     Sickle cell disease is a life-long blood condition that can cause damage to the brain and~     other organs of the body. Children may develop severe, debilitating clinical states, with~     stroke or abnormal blood flow to the brain. Treatment generally includes chronic blood~     transfusions which may cause iron overload, potentially leading to severe and sometimes fatal~     complications.~      Hematopoietic stem cell transplant using cells obtained from a sibling or an unrelated~     volunteer donor who is a perfect HLA match (same tissue type) for the recipient has shown~     to help, and possibly cure, sickle cell disease. Unfortunately, only about 10-20% of sickle~     cell patients have a HLA matched sibling donor, and the likelihood of locating an appropriate~     HLA matched unrelated donor through the various donor registries is limited.~      Stem cells from partially HLA matched family members (also called haploidentical transplant)~     is an option currently being explored for this patient population. This type of transplant~     has been used and found to be successful in some patients, mostly those with cancers of the~     blood. However, there can be significant complications with haploidentical transplant,~     primarily infection, failure of the graft to grow (graft failure), and a disorder called~     graft-versus-host disease. In addition, few patients with sickle cell disease have undergone~     this procedure. Therefore, the risks and benefits of haploidentical transplants for patients~     with sickle cell disorder are not as well established as those using an HLA identical sibling~     or unrelated donor.~      The primary objective of this study is to assess the safety of haploidentical stem cell~     transplantation for children and adolescents with severe sickle cell disease and stroke or~     abnormal transcranial Doppler ultrasound requiring chronic transfusion therapy. The treatment~     plan will be considered safe if there is not excessive toxicity. Toxicity for this protocol~     is defined as graft failure/graft rejection, severe acute GVHD, or regimen related death~     within 100 days after the last cellular product administered.~      Of note, the protocol was closed to accrual in September 2007 as we had met the stopping~     rules related to graft integrity (graft failure and graft rejection). Participants currently~     enrolled continue to be followed per protocol.~   "
259579|NCT00152100|"~     Treatment for severe combined immunodeficiency (SCID) is a medical emergency. A stem cell~     transplant (immature blood cells that can make other blood cells) from a (MSD) matched~     sibling donor (brother or sister who is a match for your child's immune (HLA) type),~     usually results in complete correction of immune function. However, most patients lack a~     matched sibling donor, requiring the use of an alternate donor source.~      Transplantation of cells from haploidentical family donors (typically parents) has resulted~     in immune system correction in the majority of SCID individuals. However, only 65-80% of~     patients survive greater than one year after this procedure. Failure results from~     life-threatening infections, graft versus host disease (GvHD) or post-transplant~     treatment-related effects. Also, for patients that survive beyond one year, B-cell (type of~     blood cell that fights infection) and natural killer cell function (cell that attacks~     infections and cancer cells) frequently fail to work, resulting in the need for long-term~     treatment with intravenous gamma-globulin (IVIg).~      In this study, in an effort to restore the overall cell function in patients with SCID,~     researchers will use a highly purified CD133+ hematopoietic cell graft (stem cell transplant~     without many mature donor white cells, called T-cells) obtained via use of the Miltenyi~     CliniMACS device, a device not FDA approved.~   "
259580|NCT00152087|"~     Surgical resection of the affected liver offers the best chance for disease-free survival in~     patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease~     which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable.~     The objective of treatment with TheraSphere is to selectively administer a dose of~     radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely~     ineffective.~   "
259581|NCT00152074|"~     The purpose of this study is to determine the effect of a modest reduction in salt intake on~     blood pressure in white, black and Asian individuals with hypertension or prehypertension,~     and also to determine whether a modest reduction in salt intake has beneficial effects on the~     surrogate markers of target organ damage in cardiovascular disease.~   "
259582|NCT00152061|"~     In this study the researchers will be enrolling patients who are failing their current~     antiretroviral regimen who also have resistance to 3TC or FTC. Patients will have their~     current antiretroviral regimen changed based on resistance testing and also be randomly~     assigned to either include, or not include 3TC/FTC in this new regimen. The purpose of the~     research is to investigate whether the change in therapy results in a decrease in the amount~     of virus particles and an increase in the CD4 cell count. In addition the researchers are~     investigating the relationship between the existence of resistance and the rate of decrease~     in viral load, and also to determine if continuing 3TC/FTC (despite being resistant to the~     medications) has any effect on the rate of decrease of viral load, or effect on CD4 counts.~   "
259583|NCT00152048|"~     The purpose of this study is to evaluate whether regular use of eflornithine 11.5% cream in~     treating women with facial hair will induce skin damage (atrophy) on the face and/or forearms~   "
259584|NCT00152035|"~     The purpose of this study is to assess the safety and effectiveness of SPD465 in the~     treatment of ADHD. The study will also look at how SPD465 affects sleep.~   "
259585|NCT00152022|"~     The purpose of this study is to assess the safety and effectiveness of SPD465 compared to~     placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also~     look at how SPD465 affects the participants sleep and how they perceive their quality of~     life.~   "
259586|NCT00152009|"~     The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine~     hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged~     6-17~   "
259587|NCT00151996|"~     The purpose of this study is to assess the safety and tolerability of administering SPD503~     (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for~     treatment of ADHD in children and adolescents aged 6-17~   "
259588|NCT00151983|"~     This study will assess the safety and tolerability of MTS while attempting to establish the~     appropriate starting dose for subjects previously on an existing long-acting methylphenidate~     product.~   "
259589|NCT00151970|"~     This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6-~     hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.~   "
259590|NCT00151957|"~     This study will evaluate the long-term safety of MTS in the symptomatic treatment of children~     aged 6-12 diagnosed with ADHD~   "
259591|NCT00151944|"~     The purpose of this study is to test the long-term safety and tolerability of SPD476 in the~     maintenance of ulcerative colitis remission.~   "
259592|NCT00151931|"~     The purpose of this study is to assess phosphate reduction and control in patients with End~     Stage Renal Disease treated with lanthanum carbonate~   "
259593|NCT00151918|"~     The purpose of this study is to assess phosphate reduction and control in patients with End~     Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride~   "
259596|NCT00151879|"~     Subjects enrolled in the SP615, SP756, or SP774 open-label extension (OLE) trials receiving~     oral SPM 927 for at least 8 weeks and a stable dose of up to 3 antiepileptic medications may~     participate in a research trial at approximately 30 locations.~      Trial objectives include investigating whether iv SPM 927 is safe and well tolerated when~     given twice daily for a short period of time and identifying the appropriate infusion~     rate(s).~      Subjects will receive SPM 927 as a 30-, 15- or 10- minute infusions twice daily for 2 - 5~     days based on notification by the research doctor and subject choice. Subjects will remain on~     the same stable dose as received in the OLE trial.~      Trial procedures will include medical history update, physical/ neurological exams, ECGs,~     blood /urine sample collections and seizure diary completion.~      Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM~     927.~   "
259597|NCT00151866|"~     The purpose of this study is to evaluate the clinical efficacy of transfusions with platelets~     stored in platelet additive solution II compared to plasma storage.~   "
259598|NCT00151853|"~     The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who~     received anticoagulant treatment and who had to undergo acute cardiac surgery with a~     cardiopulmonary bypass (CPB).~   "
259599|NCT00151840|"~     The efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, in patients~     with ITP will be assessed and compared with data obtained from literature.~   "
259600|NCT00151827|"~     This is a study in hypertensive patients with mild to moderate renal impairment. The~     antihypertensive efficacy of olmesartan medoxomil is compared to losartan.~   "
259601|NCT00151814|"~     Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with~     hypertension in ages 12 months - 16 years~   "
259602|NCT00151801|"~     Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in~     multiple sclerosis.~      The role of oral estroprogestins in the pathogenesis and in the clinical course of the~     disease is actually unknown.~      The aim of the study is to investigate safety and tolerability of association of~     estroprogestins in two different doses with interferon-beta 1a in patients with~     relapsing-remitting multiple sclerosis.~   "
259603|NCT00151788|"~     The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid~     arteries will be assessed using standard ultrasound techniques.~   "
259604|NCT00151775|"~     This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16~     with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks~     participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks.~   "
259605|NCT00151762|"~     This extension study is designed to evaluate the long-term safety and tolerability of~     colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.~   "
259606|NCT00151749|"~     The purpose of the study is to see how safe and effective and tolerable the use of WelChol®~     is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic~     drugs~   "
259607|NCT00151736|"~     This is a Phase 2, multi-center, open label, randomized clinical study to evaluate the safety~     and efficiency of SDX-101 in combination with chlorambucil (CLB) and chlorambucil alone in~     Chronic Lymphocytic Leukaemia (CLL) patients. The study treatment period will be~     approximately 24-26 weeks with a follow-up period of approximately 8 weeks. Following the end~     of treatment, patients with a confirmed complete response, partial response or stable disease~     will be followed for up to 2 years to assess time to disease progression. Approximately 80~     patients with documented diagnosis of B-cell CLL by standard clinical and immunophenotyping~     criteria will be enrolled into the SDX-101-03 study. This study is being conducted in the~     following European countries: France, Germany, Poland, Sweden and the United Kingdom.~   "
259608|NCT00151723|"~     Subclinical hyperthyroidism is defined as the presence of serum free thyroxine (T4) and~     triiodothyronine (T3) levels within the reference range and a reduced serum thyrotrophin~     (TSH) level. Evidence is accumulating that it has important clinical effects. The SUBstudy is~     a randomised, Dutch multicenter trial to study whether radioiodine treatment prevents the~     development of atrial fibrillation and prevents decreases in bone mineral density in patients~     with endogenous subclinical hyperthyroidism.~   "
259609|NCT00151710|"~     Congenital adrenal hyperplasia, an autosomal recessive condition, is mainly caused by~     mutations in the gene 21-hydroxylase and is treated with glucocorticoids in a slightly~     supraphysiological dose. Adult patients seem to be characterized by insulin resistance, which~     may be caused by the glucocorticoids and/or the accompanying obesity. The hypothesis of this~     study is that pioglitazone can improve insulin sensitivity and correlated cardiovascular risk~     factors in this specific group of patients. This will be tested in a randomized,~     placebo-controlled, cross-over trial; insulin sensitivity will be quantified by euglycemic~     hyperinsulinemic clamp studies.~   "
259610|NCT00151697|"~     Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy~     of the combination of glimepiride and short-acting insulin on weight control and glucose~     control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal~     oral treatment will be randomized to either the new combination treatment or twice daily~     injections with a mixture of short- and longacting insulin or once-daily injection with a~     basal insulin analog. The study will compare glucose control and weight gain during a year~     after randomisation between the three treatments.~   "
259611|NCT00151684|"~     The purpose of this study is to explore diazoxide efficacy in treatment of obese men and~     assessment of maximal insulin suppression in obese men without hyperglycaemia.~      Obesity is associated with markedly elevated plasma insulin levels throughout the day. The~     concept is that obese subjects predominantly develop lean tissue resistance against the~     glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and~     antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of~     hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion,~     might be useful to treat obesity because it will help to reverse the process of lipid~     storage.~   "
259654|NCT00151125|"~     This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals~     with Von Willebrand disease. The purpose is to evaluate:~        1. if rhIL-11 corrects VWF (Von Willebrand Factor) levels to normal~        2. if rhIL-11 and DDAVP together will boost VWF levels even higher~        3. the onset, peak, and duration of rhIL-11 effect~        4. if rhIL-11 is safe in individuals with Von Willebrand Disease~   "
259612|NCT00151671|"~     Cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70%~     of them develop severe complications. These failures are mainly due to hepatic insufficiency.~     Studies have already shown benefits of oral nutritional supplements in ORL, digestive, and~     cardiac surgery. We aimed to ascertain whether this nutritional, immune-enhancing~     supplementation, administered 7 days before and 3 days after surgery, could improve liver~     function and postoperative host defences in patients with liver cancer resection.~   "
259613|NCT00151658|"~     The purpose of this study is to evaluate the clinical and angiographic outcome of~     implantation of stents eluting or not eluting Sirolimus in patients with complex coronary~     artery lesions suitable for percutaneous coronary intervention.~   "
259614|NCT00151645|"~     Renal cell carcinoma represents today 3% of the solid tumors of the adult. Their bad~     prognosis is due to the frequency of metastasis and the resistance to chemotherapy.~     Immunotherapy (interferon-α, interleukin-2) has shown some good results but an important~     toxicity. In our study, we evaluate the response to a new therapeutic strategy which combines~     an injection of patient's own activated lymphocytes to a classic immunotherapy with~     interferon-α and interleukin-2.~   "
259615|NCT00151632|"~     The prevention of graft rejection after liver transplantation benefits nowadays from a~     variety of newly developed immunosuppressive agents. This allows more flexible and~     individualized immunoprophylaxis and gives an opportunity to reduce the long-term side~     effects (hypertension, renal failure, diabetes, etc.) of immunosuppression. The purpose of~     this study is to evaluate, in liver transplanted patients, if low doses of tacrolimus, given~     in combination with mycophenolate mofetil, can result in a lower rate of long-term side~     effects without increasing the rate of graft rejection.~   "
259616|NCT00151619|"~     Patients with congestive heart failure are usually treated with a combination of an ACE~     inhibitor (or an AT1 blocking agent), a diuretic and a beta-blocker. However, some patients~     remain symptomatic despite an optimal treatment with these drugs. In patients who also have~     coronary heart disease, nitrates or some calcium-channel blockers could help to relieve~     symptoms. Therefore, the aim of our study is to evaluate the additional benefit induced by a~     second generation calcium-channel blocker, amlodipine, in patients with chronic heart failure~     who remain symptomatic despite an optimal treatment.~   "
259617|NCT00151606|"~     Nosocomial infections is a major problem in intensive care units due to both growing~     incidence and pathogens implicated which become increasingly resistant to antibiotics.~     According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for~     approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to~     methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission~     of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our~     study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S.~     Aureus in intensive care units: either a reinforced isolation precautions protocol or a~     standard precautions protocol.~   "
259618|NCT00151593|"~     The aim of the study is to determine the efficacy and safety of a preservation solution in~     liver transplantation. Its efficacy will be compared to the efficacy of other currently used~     preservation solutions.~   "
259619|NCT00151580|"~     In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which~     may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is~     constant after transplantation. This recurrence usually causes chronic liver disease, in 50~     to 80% of the patients. The interest of a long-term treatment with ribavirin alone after~     transplantation has not been clearly demonstrated. The objective of our study is to evaluate~     the efficacy of ribavirin as a maintenance treatment after a one year interferon-α /~     ribavirin therapy on hepatitis C recurrence in the transplanted liver.~   "
259620|NCT00151567|"~     Ureteral stones have an important place in daily urological practice, usually causing acute~     episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to~     evaluate whether repeated administration of tamsulosin, a drug routinely used in the~     treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone~     in patients with pelvis ureterolithiasis.~   "
259621|NCT00151554|"~     According to current evidence and psychological theorizing, the provision of information~     seems to be a promising way to reduce the anxiety of patients that is related to their~     scheduled ICU stay. An ICU-specific information program will be investigated in a randomized~     controlled clinical trial involving 120 patients undergoing elective open heart surgery and~     20 patients undergoing abdominal surgery. It is expected that the patients in the test group~     will experience less anxiety and ICU related discomfort than patients in the control group.~   "
259622|NCT00151541|"~     The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel,~     (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or~     benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure~     after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.~   "
259623|NCT00151528|"~     The main purpose of this protocol is to evaluate the long-term safety of pregabalin in~     patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive~     open-label pregabalin therapy.~   "
259624|NCT00151515|"~     The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil~     formulation in males for the treatment of pattern hair loss. The secondary purpose is to~     evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for~     the treatment of pattern hair loss and to obtain the safety data on the investigational~     product when used twice daily for up to one year.~   "
259625|NCT00151502|"~     The purpose of this study is to find out if atovastatin, when taken with a cholinesterase~     inhibitor, is effective for treating Alzheimer's disease.~   "
259626|NCT00151489|"~     The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin~     reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if~     different dosages work better (reduce pain and mild to no side effects) for different people.~   "
259627|NCT00151476|"~     This is a registry-based observational study assessing clinical outcomes in FAP patients~     receiving celecoxib compared with historical/concurrent registry patients who have not~     received celecoxib.~      Both retrospective and prospective data will be utilized. No sampling methods apply.~   "
259628|NCT00151463|"~     The Quality of Erection Questionnaire (QEQ) is a new questionnaire that was developed to~     assess erectile attributes in men with erectile dysfunction. The study objective is to~     validate the Quality of Erection Questionnaire (QEQ) through the evaluation of subject~     responses to the QEQ regarding the quality and hardness of erections at baseline compared to~     subject responses post 6 and 10 weeks dosing with Viagra (sildenafil citrate).~   "
259629|NCT00151450|"~     The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the~     treatment of generalized anxiety disorder.~   "
259630|NCT00151437|"~     The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with~     acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the~     safety and tolerability of SOMAVERT.~   "
259631|NCT00151424|"~     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by~     Positive symptoms (symptoms that should not be there, inability to think clearly, to~     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or~     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and~     relate to others). Other symptoms include reduced ability to recall and learn new~     information, difficulty with problem solving, or maintaining productive employment. The~     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily~     dopamine and serotonin, which enables brain cells to communicate with each other.~      Asenapine is an investigational drug that may help to correct the imbalance in dopamine and~     serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a~     comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that~     complete this trial will have the option of continuing in an additional one year extension~     trial.~   "
259632|NCT00151411|"~     The purpose of this study is to determine if the combination therapy of lifestyle~     intervention and use of Metformin together will improve ovulation induction and~     hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and~     adolescent females.~   "
259633|NCT00151398|"~     The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of~     lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.~   "
259634|NCT00151385|"~     This investigation will utilize a systematic determination of anti-FVIII antibody specificity~     in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment~     with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of~     current or prior FVIII inhibitor will be included for comparison. The objective of this study~     is to describe the patterns of antibodies and associated epitopes in the study population.~   "
259635|NCT00151372|"~     Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major~     depression, a condition that contributes to suffering but also to poor treatment adherence~     leading to increased disability and morbidity. This study investigates the effectiveness of a~     care management intervention aimed at facilitating adherence to a treatment algorithm based~     on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators~     hypothesize that this intervention, in comparison to usual care, will increase the~     prescription of adequate antidepressant treatment by physicians, enhance treatment adherence~     by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week~     follow-up period.~   "
259636|NCT00151359|"~     Our research has shown that pressure sensation from the soles of the feet (plantar~     mechanoreceptors) plays an important role in controlling several key aspects of balancing~     reactions, particularly during compensatory stepping . As a result, age-related loss of~     plantar pressure sensation, which is very common, can lead to impaired control of these~     reactions. However, we have shown that it is possible to compensate for balance impairments~     resulting from this loss of sensation by using special footwear insoles to facilitate~     sensation from the perimeter of the sole. To date, we have demonstrated the feasibility of~     this approach in laboratory studies, and we have obtained a U.S. patent for the design~     concept. However, it remains to be determined whether the benefits of the footwear persist~     over the long term, or whether there is a habituation of the effect. Also, we need to~     determine whether there are any practical problems associated with wearing such footwear,~     e.g. due to discomfort or irritation of the skin.~   "
259637|NCT00151346|"~     The purpose of this study to compare the use of spinal-epidural versus traditional labor~     epidural on maternal and fetal effects. The hope is to determine the safest and most~     effective epidural method of relieving pain during labor.~   "
259638|NCT00151333|"~     To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in~     subjects with mild to moderate Alzheimer's disease.~   "
259639|NCT00151320|"~     Primary Objective:~      To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when~     administered in combination with CHOP + Rituximab to patients with previously untreated~     diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL)~      Secondary Objectives:~      To assess the response rate (overall and complete), event-free survival and overall survival~     with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle~     cell lymphoma (phase II component)~      Treatment:~      Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles~      Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~      VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of~     VELCADE will be determined by the following dose escalation schedule:~      Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0)~     0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4~   "
259640|NCT00151307|"~     The purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen~     saturation (over 40%) on patients undergoing cardiac surgery. Effects on neuropsychological~     outcome, length of ICU stay, and length of hospital stay will be measured.~   "
259641|NCT00151294|"~     Emotionally labile, depressed participants with multiple sclerosis treated with escitalopram~     will have a greater reduction in emotional lability scores and in their psychological~     distress scores than those who are randomized to receive placebo.~   "
259655|NCT00151112|"~     The purpose of this study is to investigate the influence of difference positioning on~     extension and efficacy of brachial plexus anesthesia at 20 minutes by using the axillary~     plexus block with supine positioning and a lateral positioning onto the non-anaesthetized~     side, combined with 20° Trendelenburg positioning.~   "
259642|NCT00151281|"~     Primary Objective:~      Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide,~     and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle~     cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be~     assessed.~      Secondary Objectives:~        1. Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell~          lymphoma.~        2. Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma~          during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated~          with clinical response to RT-PEPC therapy.~        3. Assess the quality of life of patients receiving RT-PEPC treatment~   "
259643|NCT00151268|"~     In a separate protocol the Department of Genetic Medicine is proposing to carry out a study~     using gene transfer to treat the central nervous system (CNS) manifestations of late~     infantile neuronal ceroid lipofuscinosis (LINCL), a fatal, rare, recessive disorder of the~     (CNS) in children. In the context that there is little known about the genotype - phenotype~     correlations of LINCL, and that our referral far exceed the number (n=11) of children that~     will be entered into the gene transfer protocol, we are proposing to capitalize on this~     unique opportunity to evaluate this disorder in this separate study. In this context, the aim~     of this protocol is to study the genotype - phenotype correlations of the CNS manifestations~     of late infantile neuronal ceroid lipofuscinosis. This will be accomplished by comparing the~     genotype to a neurologic assessment, and LINCL clinical rating scale; magnetic resonance~     imaging (MRI) and magnetic resonance spectroscopic (MRS) assessments of the CNS; and routine~     clinical evaluations.~   "
259644|NCT00151255|"~     This is a study looking at all-trans retinoic acid in combination with standard induction and~     consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).~   "
259645|NCT00151242|"~     This trial is a study on all-trans retinoic acid in combination with induction and~     consolidation therapy as well as pegfilgrastim after consolidation therapy in younger~     patients with newly diagnosed acute myeloid leukemia (AML).~   "
259646|NCT00151229|"~     The aim of this study is to compare the incidence of cardiovascular events between two target~     systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with~     valsartan in elderly isolated systolic hypertensive patients in Japan.~   "
259647|NCT00151216|"~     The aim of this study is to treat the signs and symptoms of late infantile neuronal ceroid~     lipofuscinosis (LINCL), a fatal inherited disease in the brain. This will be accomplished by~     using delivery of a gene (method called gene transfer) to administer to the brain an~     experimental drug called AAV2CUhCLN2, a gene transfer vector.~   "
259648|NCT00151203|"~     PRIMARY STUDY OBJECTIVES~        -  To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide~          (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with~          newly diagnosed multiple myeloma (MM).~        -  To evaluate the safety of the combination of clarithromycin, lenalidomide, and~          dexamethasone as an induction therapy for patients with newly diagnosed MM.~      SECONDARY STUDY OBJECTIVES~        -  To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone~          and lenalidomide.~        -  To examine the angiogenesis profile in untreated patients and in patients receiving~          induction therapy.~   "
259649|NCT00151190|"~     The study is intended to determine the effectiveness and efficiency of a community diabetes~     education program administered by a community health worker in a low-cost community clinic.~     We expect an improvement in overall glycemic control in the experimental group of at least~     20%. We also expect to document improvement in diabetes self-management skills, quality of~     life and an increase in achievement of ADA standards of care4 in the experimental group.~   "
259650|NCT00151177|"~     More than half of all stroke patients have sleep apneas in the acute phase after stroke.~     Sleep apneas may be associated with higher degrees of disability three months after stroke~     due to numerous factors associated with sleep apneas such as persistent hypertension, cardiac~     arrhythmias, and clotting disorders.~      Non-invasive CPAP (continuous positive airway pressure)-therapy may reverse a number of these~     effects very shortly after initiation. The aim of the study is to test the feasibility of~     early non-invasive CPAP treatment starting in the first night after stroke onset, and to test~     its efficacy in a randomized clinical trial.~      50 patients with acute ischemic stroke will be enrolled and randomly assigned to standard~     care PLUS CPAP treatment or standard care only. All patients randomized to the intervention~     group will receive CPAP therapy for the first three nights after stroke. In the fourth night,~     a cardiorespiratory polygraphy will be performed in patients and controls. Patients assigned~     to the intervention group with a respiratory distress index > 10/h will be treated further~     on. On admission, day 4, and day 10 after stroke, diffusion weighted MRI imaging will be~     performed to determine the size of the infarction. The NIHSS score will be used to assess~     clinical short-term outcome on day 4 and day 10. After three months, the outcome will be~     determined using the modified Rankin scale.~      As CPAP therapy may be more laborious for the provider, the additional work-load will be~     documented using pre-specified scales.~      Primary hypothesis of the study is, that CPAP therapy is feasible in acute stroke patients~     and that the additional work load will not outweigh the benefits.~      Secondary hypothesis is that patients assigned to the treatment group have smaller~     infarctions on MRI and less neurological deficits at 3 months after stroke.~      Patients entering the study will be investigated by transcranial Doppler ultrasound in case~     they have sufficient temporal bone windows for insonation and no stenosis or occlusions of~     major brain supplying arteries by the time of investigation that disturb the intracerebral~     blood flow.~      All intracranial arteries will be assessed before treatment, after treatment and on day 8~     after the insult.~      Screen shots will be taken and will be analysed by dynamic vascular ultrasound (DVA), a new~     software algorithm developed by NHSi, to investigate microcirculatory information from the~     flow spectra of the major intracranial arteries.~      The data from this post-hoc analysis are compared with the data of the polysomnography and~     with treatment.~      Primary hypothesis in this substudy is that DVA reliably identifies patients with sleep apnea~     on days one and four after stroke. Secondary hypothesis is that DVA can distinguish between~     treated patients and controls.~   "
259651|NCT00151164|"~     The investigators hypothesize that injecting donor bone marrow cells into the recipient~     thymus gland at the time of heart transplantation in children will prove to be feasible and~     safe. They further hypothesize that recipients receiving donor bone marrow will experience~     less acute rejection events with reduced long-term requirements for immunosuppressive~     medications when compared to controls who do not receive marrow but who are managed under an~     identical immunosuppressive protocol.~   "
259652|NCT00151151|"~     This is a randomized clinical trial assessing the efficacy of two types of counseling~     (Computer-Assisted Motivational Intervention [CAMI] versus Didactic Educational Counseling~     [DEC]) to see which can better reduce female adolescents' risk taking behaviors that put them~     at risk for unintended pregnancy and sexually transmitted diseases (STDs). The intervention~     phase consists of three 30-minute counseling sessions over the first 6 months followed by a~     visit every three months during the 12 month follow up phase. We, the researchers,~     hypothesize that the CAMI will decrease the proportion of subjects who engage in any~     intercourse that is poorly protected against pregnancy and against STDs.~   "
259653|NCT00151138|"~     Randomized trial of two antihypertensive drugs of known efficacy to investigate whether one~     has more favorable effects on brain blood flow and cognitive function.~   "
259657|NCT00151086|"~     Purpose: This clinical trail will combine the chemotherapy drugs, Estramustine and~     Vinorelbine (Navelbine), on an intermittent therapy strategy based on PSA response in the~     treatment of hormone refractory prostate cancer. The investigators will determine the~     tolerable dose of (oral) vinorelbine in combination with (oral) estramustine, and evaluate~     the efficacy of this treatment for patients with hormone-refractory prostate cancer.~   "
259658|NCT00151073|"~     Purpose: The aim of this clinical trail is to evaluate the effectiveness of Zoledronate~     (Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients~     with hormone-refractory prostate cancer.~   "
259659|NCT00151060|"~     Hormonal therapy is the standard treatment for prostate cancer which has spread to other~     areas of the body. Despite the high initial response rates to hormonal therapy, the vast~     majority of men will develop cancer which is no longer responsive to hormone deprivation. The~     average time for hormonal therapy to be effective is about 18 months. Chemotherapy~     combinations which can treat the disease when it no longer responds to hormonal therapy have~     been developed, but these treatments are not curative. One of these combinations is~     estramustine, etoposide and paclitaxel. In men with far advanced disease, 60% will have a~     decrease in their PSA (Prostate Specific Antigen) or shrinkage of tumors after treatment with~     this chemotherapy. Despite this, these men have all developed further disease progression~     requiring additional treatment. One possible way to make chemotherapy more effective is to~     give it when the number of tumor cells is smallest, and the number of cells to be killed is~     at a low level. One situation in which this is true is when a man has responded to hormonal~     therapy any tumors are at their smallest size. This study will test whether the addition of~     chemotherapy at that time will prolong the time until the cancer becomes unresponsive to~     hormonal therapy.~   "
259660|NCT00151047|"~     Purpose: The purpose of this clinical trial is to look at the chemotherapy combination of~     docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate~     cancer, and to determine if this treatment is an acceptable, effective and a safe treatment~     option. In addition, this clinical trial will evaluate how this treatment affects chemicals~     (enzymes), and other cancer related genetic changes in the tumor. Optional: This clinical~     trial will conduct extra imaging studies for research purposes including combined endorectal~     prostate magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRSI) and~     diffusion weighted imaging (DWI) to evaluate prostate cancer and response to study treatment.~   "
259661|NCT00151034|"~     Purpose: The purpose of this study is to evaluate the efficacy and safety of treatment with~     trastuzumab (Herceptin) along with the three other chemotherapy drugs, paclitaxel,~     carboplatin and gemcitabine, in patients who have advanced urothelial cancer. This clinical~     trial will also collect information (alternative therapy, response rates, overall survival)~     from enrolled patients with HER2 negative tumors who are ineligible to receive study~     treatment.~   "
259662|NCT00151021|"~     The primary purpose of this study is to test an Internet based program along with an enhanced~     pedometer to promote walking in people with diabetes. The major research question to be~     answered is if counseling and feedback that emphasizes a 10-minute minimum duration for~     physical activity bouts result in a different pattern of walking behavior compared to~     counseling and feedback focusing only on total daily accumulated steps.~   "
259663|NCT00151008|"~     To determine if bexarotene gel with NBUVB phototherapy is more effective than placebo plus~     NBUVB for moderate to severe plaque-type psoriasis.~   "
259664|NCT00150995|"~     Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the~     treatment of hormone refractory prostate cancer.~   "
259665|NCT00150982|"~     To determine the mechanism of action of alefacept in patients with psoriasis.~   "
259666|NCT00150969|"~     The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily~     over a 2-year period will prevent bone loss in post-menopausal women with osteopenia.~   "
259667|NCT00150956|"~     This study was designed to discover mechanisms responsible for the decrease in (high) blood~     pressure after starting daily hemodialysis, as has been observed by various investigators. We~     hypothesized that better control of body water and sodium content and a decline in the~     autonomic (sympathetic) nervous system activity, increased in chronic renal failure patients,~     would contribute to improved blood pressure regulation.~      Moreover, we studied the effects of daily hemodialysis on mental functions, like information~     processing and memory, in relation to the previously reported improvement in quality of life,~     and the effects on nutrition. We hypothesized that all would improve.~   "
259668|NCT00150943|"~     Background:~      Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal~     function and is one of the most important causes of renal failure in the elderly. Current~     treatment includes restoration of the renal arterial lumen by endovascular stent placement.~     However, this treatment only affects damage caused by ARAS due to the stenosis and ensuing~     post-stenotic ischemia. ARAS patients have severe general vascular disease. Atherosclerosis~     and hypertension can also damage the kidney parenchyma causing renal failure. Medical~     treatment focuses on the latter. Lipidlowering drugs (statins) could reduce renal failure~     progression and could reduce the overall high cardiovascular risk. The additional effect on~     preserving renal function of stent placement as compared to medical therapy alone is unknown.~     Therefore, the STAR-study aims to compare the effects of renal artery stent placement~     together with medication vs. medication alone on renal function in ARAS patients.~      Method:~      Patients with an ARAS of ≥50% and renal failure (creatinine (Cr) clearance <80 mL/min/1.73~     m2) are randomly assigned to stent placement with medication or to medication alone.~     Medication consists of statins, anti-hypertensive drugs and antiplatelet therapy. Patients~     are followed for 2 yrs with extended follow-up to 5 yrs. The primary outcome of this study is~     a reduction in Cr clearance >20% compared to baseline. This trial will include 140 patients.~   "
259669|NCT00150930|"~     UVB phototherapy is a commonly used treatment for patients with psoriasis. Generally it is~     performed in the outpatient department of the hospital. The UVB irradiation itself will~     normally take only a few minutes, but to receive the irradiation patients have to travel to~     the outpatient department during working hours 2 or 3 times a week. In general it is a~     relatively time-consuming treatment.~      Objective of this study is to assess whether UVB treatment administered in the home is as~     equally effective as the standard outpatient UVB phototherapy. Quality of life and~     cost-effectiveness are also studied.~   "
259670|NCT00150917|"~     One in 10 Canadian women will be diagnosed with breast cancer (BC) and approximately 5% of~     all BC is believed to be hereditary. Women with a family history experience high levels of~     perceived risk for developing BC. Elevated risk perceptions for BC have been associated with~     psychological distress, which, in turn, can interfere with screening adherence. In our~     completed CBCRI-funded study, we developed and standardized a group intervention designed to~     address the psychological issues associated with having a family history of BC. Results~     demonstrated that the intervention led to significant improvement in levels of anxiety and~     depression, improved BC risk factors/genetics knowledge and was associated with optimal~     screening behavior. The proposed study will rigorously test the group intervention in~     comparison to standard risk counselling in a sample of 150 women recruited from Familial BC~     clinics in Toronto. The interventions will be examined for their impact on a) psychological~     functioning, b) BC risk/genetic knowledge and c) screening behaviors.~   "
259671|NCT00150904|"~     Hepatitis C and HIV infect worldwide millions of people leading to a high rate of coinfected~     patient with eventually liver cirrhosis and endstage liver disease. With the currently best~     available therapy (peginterferon and ribavirin) only less than 50% of patients with HCV~     genotype 1 will respond. Unknown is what factors determine this difference in treatment~     outcome. Probably virologic and immunologic factors play a major role. By investigating blood~     samples of HCV / HIV coinfected patients and HCV mono-infected patients we would like to~     examine both virologic and immunologic factors possibly responsible for this difference.~   "
259672|NCT00150891|"~     Chronic transplant rejection remains the main cause of late kidney graft loss. We showed~     previously that patients with pretransplant CD4 helper defects and low in-vitro IL-10~     responses demonstrated an extremely low risk of acute rejection and a significantly better 1-~     and 3-year graft function whereas pretransplant Th1 responses were not predictive (Weimer R~     et al. 1996 and 1998). In liver transplant recipients, we found CD4 helper function and~     in-vitro IL-10 responses significantly decreased compared to CsA-treated patients (Zipperle~     et al. 1997). If the same effect will be demonstrated in renal transplant recipients,~     Tacrolimus (Tacr) treatment might result in enhanced graft survival compared to CsA, when CD4~     helper function and in-vitro IL-10 responses of the individual patient are elevated. Other~     studies of our group suggest a beneficial role of enhanced T-suppressor activity and of an~     IL-6 independent B cell/monocyte defect in the maintenance of long-term stable graft~     function, whereas enhanced monokine secretion (TNF-a, GM-CSF, IL-6) was found in chronic~     rejection (Weimer et al. 1990, 1992, 1994, 1998).~      In the current randomized prospective study we will analyze the impact of CsA versus Tacr and~     of MMF versus azathioprine on Th1, Th2 and monokine responses and their predictive value~     regarding occurrence of acute and chronic rejection. With a proposed follow-up of 5 years~     this study might enable a patient-tailored immunosuppressive therapy resulting in prolonged~     graft survival.~   "
259673|NCT00150878|"~     The primary goal of the study is to show that the treatment-related mortality of allogeneic~     hematopoietic stem cell transplantation an be significantly reduced by using a combination of~     8 Gy total-body-irradiation and fludarabine in comparison to the conventional combination of~     12 Gy TBI and 120 mg/kg Cyclophosphamide.~   "
259674|NCT00150865|"~     Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group~     randomized, includes 30 patients. block performed preoperatively Surgery under general~     anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine~     consumption via PCA device. Follow-up : 24h.~      Expectation : sizeable reduction of pain with block, of duration.~   "
259675|NCT00150852|"~     The aim of this study is to determine whether vancomycin with cefazoline is superior to~     vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of~     methicillin-resistant staphylococcus aureus (MRSA).~   "
259676|NCT00150839|"~     The proposed study is a randomized, placebo-controlled, double-blind trial to evaluate the~     safety and efficacy of antidepressant combination for the treatment of depression.~      Depressive disorder is one of the most common human diseases with a high burden for every~     patient, her/his family, health care system and society as a whole. Actual treatment concepts~     of depressive disorders include pharmacologic, biologic (e.g. electroconvulsive therapy,~     light therapy) and psychologic therapy. Even though effective therapeutic options are at~     hand, therapy needs time. It is often not possible to reach full remission of the disease and~     10-25% of patients suffering from depression are regarded as treatment-resistant. In~     treatment resistant depression, the use of a combination of antidepressive drugs is~     considered safe and effective. However, at present no data exist concerning the use of drug~     combination as primary therapeutic option. The aim of the study is to examine the hypothesis,~     that significantly more patients achieve full remission of depressive symptoms when treated~     with the combination of two antidepressants and as a secondary hypothesis, that patients~     receiving a drug combination will achieve remission faster than patients treated with~     monotherapy. To test these hypotheses, a two group parallel design is used comparing the~     efficacy and safety of mirtazapine in combination with venlafaxine or placebo.~   "
259677|NCT00150826|"~     INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin~     converting enzyme) inhibition (quinapril) in improving coronary microvascular function.~      PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE~     (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow~     reserve limitations and evidence for myocardial ischemia in the absence of significant~     coronary artery stenosis.~      STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT~     Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow~     reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific~     variables, and site by treatment effects.~      SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle~     Angina Questionnaire adjusting for baseline values, site, and site by treatment effects.~      SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and~     occurrence of adverse events.~      STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the~     study has been provided. Interim analyses are planned after 15 patients have been enrolled in~     each group.~      ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT~     EACH SITE Approximately 26~   "
259678|NCT00150813|"~     An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse~     events reporting.~   "
259681|NCT00150774|"~     A double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with~     LEV 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from~     idiopathic generalised epilepsy and to evaluate the safety of LEV in the same population.~   "
259682|NCT00150761|"~     Phase IV, human pharmacology, exploratory, randomized, 3-way (3 treatment periods)~     cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine~     and cetirizine by means of IR thermography.~   "
259683|NCT00150748|"~     An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in~     children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.~   "
259684|NCT00150735|"~     A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used~     as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from~     epilepsy, and experiencing partial or generalized tonic-clonic seizures.~   "
259685|NCT00150722|"~     It is well known that lowering low-density lipoprotein (LDL) (bad cholesterol) is beneficial~     for decreasing heart attacks and death. More recently, focus has been on trying to raise HDL~     (good) cholesterol. The purpose of the present study is to determine if the addition of a~     sustained release preparation of niacin (Niaspan - a medicine to raise HDL cholesterol) to~     LDL lowering with a statin type medication results in improved vascular health. The study of~     the well being of one's vessel wall (endothelial function) will serve as a marker of~     treatment effect in the study.~      Hypotheses: Extended-release (ER) niacin will improve endothelial function measured as~     brachial flow-mediated dilation (FMD - 10 end-point) and as pulse volume amplitude by pulse~     arterial tonometry (PAT) (20 end-point) in subjects with established atherosclerosis whose~     LDL cholesterol is optimally treated with statin therapy.~   "
259686|NCT00150709|"~     The open-label study to allow pediatric patients who have participated in prior Levetiracetam~     (Keppra®) studies to continue their treatment with adequate monitoring and standardized~     follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the~     completion of the development program for pediatrics.~   "
259687|NCT00150696|"~     The purpose of this study is to find out if Risedronate works to prevent osteoporosis after~     spinal cord injury.~   "
259688|NCT00150683|"~     The purpose of this study is to find out if standing and/or standing with vibration works for~     the treatment of osteoporosis for people with a spinal cord injury.~   "
259689|NCT00150670|"~     This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy~     compared with the monotherapy by TS-1 alone.~   "
259690|NCT00150657|"~     -  this study is being done to find out if the combination of carboplatin and gemcitabine~          will be more effective in the the treatment of advanced lung cancer if bevacizumab, an~          agent that blocks tumor blood vessel formation, is added~        -  the study will measure the time to progression of patients treated with the combination;~          we hope to show that the addition of bevacizumab improves the time to progression~          (increases the amount of time before the disease begins to worsen)~        -  all patients receive all three drugs; there is no placebo~   "
259691|NCT00150644|"~     The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of~     asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the~     morphology of the endometrium and uterine fibroids.~   "
259692|NCT00150631|"~     The present study examine healthy, normotensive subjects 18 to 36 years of age whose both~     parents have essential hypertension. The subjects receive treatment with either the~     AT1-antagonist candesartan cilexetil, 16 mg daily or placebo for one year. Then, treatment is~     withdrawn and the subjects is followed for 10 years to determine if the treatment has been~     able to either prevent or delay the development of hypertension. The primary objective is to~     determine whether pharmacological treatment with an angiotensin receptor blocker is able to~     restrain or delay the progression to hypertension. Secondary objectives are to investigate~     whether any long-term effect on blood pressure is related to the effect of treatment on renal~     haemodynamic function, or on the left ventricle mass.~   "
259693|NCT00150618|"~     The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the~     treatment of children and adolescents aged 6-17 with ADHD.~   "
259694|NCT00150605|"~     The purpose of this study is to evaluate the safety of SPD417 when given with other~     psychotropic medications to treat bipolar I disorder.~   "
259695|NCT00150592|"~     The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks~     of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.~   "
259696|NCT00150579|"~     The purpose of this study is to assess the safety and effectiveness of SPD465 compared to~     placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also~     look at how SPD465 affects sleep and how the participants perceive their quality of life.~   "
259697|NCT00150566|"~     The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the~     pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal~     disease.~   "
259698|NCT00150553|"~     The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar~     manic symptoms, when given once daily in the evening vs. twice daily.~   "
259699|NCT00150540|"~     The purpose of this study is to assess the safety of lanthanum carbonate in patients~     undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to~     continue treatment.~   "
259718|NCT00150280|"~     To validate the analgesic efficacy and safety of celecoxib compared with ibuprofen SR in the~     management of acute pain post orthopedic or gynecological surgery~   "
259719|NCT00150267|"~     To estimate the frequency of patients with ocular/periorbital adverse events. To identify any~     possible long-term adverse consequences of increased iris pigmentation and to follow serious~     adverse events throughout the study period.~   "
259720|NCT00150254|"~     The purpose of the study is to measure the safety and efficacy of four dosing strategies of~     CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up~     of smoking status to one year from randomization was performed in a non-treatment extension~     Protocol A3051018~   "
259721|NCT00150241|"~     The purpose of the study is to measure the safety and efficacy of three doses of varenicline~     for smoking cessation.~   "
259700|NCT00150527|"~     Citalopram, a selective serotonin reuptake inhibitor (SSRI), is used as a neuroendocrine~     probe in human subjects to assess serotonin (5-hydroxytryptamine; 5-HT) function as reflected~     in prolactin and plasma cortisol release. Citalopram is a racemic mixture of equal parts of~     the S(+) and R(-) enantiomers. The S(+) form (escitalopram) has been identified as being~     the active isomer and inhibitor of serotonin reuptake and consequently antidepressant~     activity is associated almost exclusively with the S-enantiomer. Escitalopram has been shown~     to be approximately twice as potent as citalopram at the primary, high-affinity binding site~     on the human serotonin transporter. Interestingly, investigations have suggested an~     antagonistic interaction of the R- and S-enantiomer at an allosteric binding site on the~     serotonin transporter. This antagonism has been shown in animal studies where the addition of~     R-citalopram to escitalopram treatments significantly counteracts the antidepressant and~     anti-anxiolytic effects of escitalopram. From these clinical and experimental data, the~     researchers can anticipate that escitalopram would increase cortisol and prolactin in the~     neuroendocrine challenge paradigm more effectively than citalopram.~   "
259701|NCT00150514|"~     The objective of the study is to document the objective immunological effects of SLIT on the~     nasal mucosa. Better understanding of these immunological pathways, in which this widely~     practised clinical therapy is likely to work, can only benefit the overall outcome of this,~     more patient friendly, therapy and it will demonstrate the effects of SLIT on the allergic~     reaction, with objective parameters, in the nasal tissues showing it to be a true etiological~     treatment of allergy.~   "
259702|NCT00150488|"~     This protocol describes a multi-centre, community based open label study designed to assess~     the efficacy and safety of intravesical sodium chrondroitin sulfate (Uracyst®) in the~     treatment of patients with a clinical diagnosis of interstitial cystitis (IC).~      The safety of the study product will be evaluated through the incidence of adverse events and~     from results of physical examinations and laboratory tests.~   "
259703|NCT00150475|"~     Highly communicable and virulent diseases, the ongoing threat of emerging infectious~     diseases, and the prospect of bio-terrorism have become part of the new reality for health~     care workers. SARS transmission has occurred despite the use of droplet, contact, and~     airborne precautions. Potential explanations for some of the episodes of~     “through-precautions” transmission include the possibility of contamination during removal of~     protective clothing.~      The recommended protective systems (PPS) for aerosol generating procedures set out by the US~     Center for Disease Control and Prevention (CDC) and the Ontario Ministry of Health and Long~     Term Care (MOHLTC) differ.~      The failure of a PPS may be associated with significant consequences in terms of the~     morbidity and mortality of front-line health care workers. The purpose of this study is to~     determine if a difference exists between the rate of self-contamination due to deficiencies~     in contact precautions for individuals wearing either the CDC or MOHLTC recommended PPS.~      Study participants will don one of the two recommended PPS, be “contaminated” with an~     indicator that becomes visible under ultraviolet light, and then assessed for contamination~     of clothing layers and skin after removal of the PPS. They will then repeat the procedure~     using the other PPS.~   "
259704|NCT00150462|"~     The purpose of this study is to test the safety and tolerability of carfilzomib at different~     dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma,~     Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor,~     an enzyme responsible for degrading a wide variety of cellular proteins.~   "
259705|NCT00150449|"~     Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.~   "
259706|NCT00150436|"~     To evaluate long-term safety and efficacy of pregabalin in patients with postherpetic~     neuralgia.~   "
259707|NCT00150423|"~     To evaluate the safety and efficacy of pregabalin in patients with painful diabetic~     peripheral neuropathy.~   "
259708|NCT00150410|"~     -  Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an~          investigational drug, controls your diabetes at least as much as a triple combination~          therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration~          (FDA) approved drug.~        -  Whether a combination of two therapies - metformin plus Exubera controls your diabetes~          at least as much as a as a triple combination therapy of metformin and a sulfonylurea~          plus Avandia.~   "
259709|NCT00150397|"~     This is an initial proof of concept, phase to study to assess the safety and efficacy~     tofimilast for the chronic maintenance treatment of adults with persistent asthma~   "
259710|NCT00150384|"~     The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African~     American population~   "
259711|NCT00150371|"~     The objective of this study is to assess the effectiveness of an atorvastatin treatment~     regimen involving starting doses between 10 and 80 mg, followed by a single-step titration~     (except for subjects started at 80mg), if required~   "
259712|NCT00150358|"~     To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and~     antihypertensive therapy.~   "
259713|NCT00150345|"~     A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the~     number of white blood cells, especially of the so-called neutrophil granulocytes, which are~     very important for the defense against infections. Hence their decrease (called~     neutropenia) leads to a predisposition to infections.~      Since infections during neutropenia can be very dangerous, the patients are treated with~     antibiotics from the very first signs of such an infection (usually fever). If the~     antibiotics (drugs against bacteria) do not lead to a normalization of the body temperature~     within four days, a drug against fungi is added.~      In the IDEA study, one half of the patients receive the antifungal drug voriconazole (as~     usual) only in case the antibiotics alone do not lead to a normalization of the body~     temperature (current standard of care). The other half of the patients receive voriconazole~     immediately after onset of fever (concomitantly with the antibiotics).~      The research question is, whether in the early-treatment group fewer manifest fungal~     infections will be observed than in the late-treatment group.~   "
259714|NCT00150332|"~     Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in~     Japan~   "
259715|NCT00150319|"~     This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous~     voriconazole and SBECD in patients with moderate renal insufficiency~   "
259722|NCT00150228|"~     The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing~     strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up~     of smoking status to one year from randomization was performed in a non-treatment extension~     Protocol A3051019~   "
259723|NCT00150215|"~     The purposes of this study are:~        -  To determine the safety, tolerability and pharmacokinetics of single doses of~          PF-00184562; and~        -  To explore the exposure-response relationship of neuropsychometric and tolerability~          measures of PF-00184562 compared to olanzapine.~   "
259724|NCT00150202|"~     This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients~     with wet-type AMD, in order to establish that there is no large difference in the efficacy~     and the safety of the drug between Western and Japanese patients.~   "
259725|NCT00150189|"~     The study explores the potential benefits of a sugar water solution for decreasing pain in~     infants during routine immunizations.~   "
259726|NCT00150176|"~     Schizophrenia is a brain disease. The condition may be associated with acute psychotic~     episodes and long-term disability despite remission from the acute symptoms. Current~     management of schizophrenia focuses on the treatment of acute symptoms as well as long-term~     treatment aimed at preventing relapse after patients have experienced an improvement in acute~     symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse~     within 1-2 years after an acute episode of schizophrenia. Patients who remain on~     antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation~     when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in~     the brain, primarily dopamine and serotonin, which enables brain cells to communicate with~     each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The~     purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing~     relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been~     treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine~     the safety and tolerability of asenapine for up to 1-year of treatment.~   "
259727|NCT00150163|"~     Objective:~        -  To define a reference-population of healthy young men (20-29 years old).~        -  To establish reference-intervals for:~             1. Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone,~               androstenedione) and serum estrogens (estradiol, estrone).~             2. Total and free IGF-1.~        -  To study the influence of physical activity, alcohol intake, tobacco and abuse of~          anabolic steroids on serum levels of androgens.~        -  To identify the androgens (or estrogens) that primarily reflect the following~          parameters:~             1. Muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit.~             2. Bone mineral density and bone metabolism.~             3. Total and visceral fat mass.~             4. Lipid- and glucose metabolism and glucocorticoid metabolism.~             5. Sexual function and quality of life.~        -  To study the modifying effect of birth weight, the AR gene CAG-repeat polymorphism, and~          the level of IGF-1 on associations between serum androgens and the measures above:~      Ethics, design and schedule:~      The local ethic review board approved a population-based, cross-sectional study planned for~     the inclusion of 800 Caucasian men, 20 to 29 year old, living in the County of Funen. The~     only exclusion criteria were opioid drug addiction, cancer, and severe chronic disease. A~     basic questionnaire was mailed to 3000 men, randomly drawn from the Danish Central Personal~     Registry. Adequately answered questionnaires were returned from 2,199 men, who subsequently~     received an invitation to participate. Informed consent was obtained from 783 men. The~     examinations started in March 2002 and terminated in May 2003. Within subject variation was~     determined for all study parameters in 20 men. The men included matched the men answering the~     questionnaire on all questionnaire items and demographics. All analyses have been performed,~     except for the additional serum sex hormone assays, IGF-1 assays and AR gene analyses.~      A sequential rule-out from the reference population was performed on the following criteria:~        1. testicular pathology: bilateral cryptorchidism, varicocele, testes volumina < 10 ml~          (each), history of spermatic cord torsion.~        2. severe chronic disease.~        3. regular medication or abuse of anabolic steroids.~        4. body mass index < 19 kg/m2.~        5. safety serum parameters: luteinizing hormone (LH) <1.0 U/L or >8.4 U/l,~          alanine-amino-transferase (ALAT) >70 U/l and thyrotropin (TSH) >6.0 mU/l.~   "
259728|NCT00150150|"~     Nodular goitre is common in the general population and less than 5% of the patients who~     undergo surgery for solitary thyroid nodules have cancer, in absence of clinical suspicion.~     Nodules left untreated seem to have a slight growth potential in borderline iodine-deficient~     areas. Interstitial laser photo-coagulation (ILP) is a procedure for local hyperthermia and~     photocoagulation, allowing minimally invasive treatment of benign tumors, including thyroid~     nodules. The aim of these studies are to evaluate if ILP will be useful in reducing the~     volume of the benign thyroid nodule and thyroid function will be unaffected in euthyroid~     patients, and normalized in pretoxic- and toxic thyroid nodules. The investigations are~     listed below:~        1. Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid~          nodules – one versus two or three treatments~        2. Randomized study of interstitial laser photocoagulation for benign solitary autonomous~          thyroid nodules – 131I versus laser ablation~        3. Interstitial laser photocoagulation for benign thyroid cystadenomas. – a feasibility~          study.~   "
259729|NCT00150137|"~     Background: The use of radioactive iodine (131I) therapy as the definite cure of~     hyperthyroidism is widespread. According to a survey on the management of Graves’ disease,~     thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs~     (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced~     ‘thyroid storm’, which, however, is rarely encountered. Several studies have consistently~     shown that patients who are treated with ATD prior to 131I therapy have an increased risk of~     treatment failure. Mostly, patients with Graves’ disease have been studied, while other~     studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD~     have ‘radioprotective’ properties, although this view is almost exclusively based on~     retrospective data and is still under debate (13). Indeed, this dogma was recently challenged~     by two randomized trials in Graves’ disease, none of which showed such an adverse effect of~     methimazole pretreatment. It cannot be excluded that the earlier results may have been under~     influence of selection bias, a source of error almost unavoidable in retrospective studies.~     Whether ATD is radioprotective also when used in the post 131I period has also been debated.~     In the early period 131I therapy following a transient rise in the thyroid hormones is seen~     which may give rise to discomfort in some patients. The continuous use of ATD during 131I~     therapy leads to more stable levels of the thyroid hormones. By resuming ATD following 131I~     therapy, euthyroidism can usually be maintained until the destructive effect of 131I ensues.~     Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting~     that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the~     evidence is based on retrospective studies and the ideal set-up should be reconsidered. To~     underscore the importance of performing randomized trials we showed recently that resumption~     of methimazole seven days after 131I therapy had no influence on the final outcome.~      Aim: To clarify by a randomized trial whether continuous use of methimazole during~     radioiodine therapy influences the final outcome of this therapy, in a comparison with a~     regime in which methimazole as mono-therapy is discontinued 8 days before radioiodine.~      Patients and Methods: 80 consecutive patients suffering from recurrent Graves’ disease or a~     toxic nodular goiter are included. All patients are rendered euthyroid by methimazole (MMI)~     and randomized either to stop MMI eight days before 131I or to continue MMI until four weeks~     after 131I. Calculation of the 131I activity (max. 600 MBq) includes an assessment of the~     131I half-life and the thyroid volume. Patients are followed for one year with close~     monitoring of the thyroid function.~   "
259775|NCT00149526|"~     To improve asthma outcomes by developing and evaluating strategies for enhancing the~     clinic-patient partnership. To develop a model of shared decision-making for asthma~     treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged~     18-70 years with sub-optimally controlled persistent asthma.~   "
259730|NCT00150124|"~     Background: The use of radioactive iodine (131I) therapy as the definite cure of~     hyperthyroidism is widespread. According to a survey on the management of Graves' disease,~     thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs~     (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced~     'thyroid storm', which, however, is rarely encountered. Several studies have consistently~     shown that patients who are treated with ATD prior to 131I therapy have an increased risk of~     treatment failure. Mostly, patients with Graves' disease have been studied, while other~     studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD~     have 'radioprotective' properties, although this view is almost exclusively based on~     retrospective data and is still under debate. Indeed, this dogma was recently challenged by~     two randomized trials in Graves' disease, none of which showed such an adverse effect of~     methimazole pretreatment. It cannot be excluded that the earlier results may have been under~     influence of selection bias, a source of error almost unavoidable in retrospective studies.~     Whether ATD is radioprotective also when used in the post 131I period has also been debated.~     In the early period 131I therapy following a transient rise in the thyroid hormones is seen~     which may give rise to discomfort in some patients. The continuous use of ATD during 131I~     therapy, possibly in combination with levothyroxine (BRT: block-replacement therapy), leads~     to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy,~     euthyroidism can usually be maintained until the destructive effect of 131I ensues.~     Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting~     that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the~     evidence is based on retrospective studies and the ideal set-up should be reconsidered. To~     underscore the importance of performing randomized trials we showed recently that resumption~     of methimazole seven days after 131I therapy had no influence on the final outcome.~      Aim:To clarify by a randomized trial whether BRT during radioiodine therapy of hyperthyroid~     patients influences the final outcome of this therapy, in a comparison with a regime in which~     methimazole as mono-therapy is discontinued 8 days before radioiodine.~      Patients and Methods: Consecutive patients suffering from recurrent Graves' disease (n=50) or~     a toxic nodular goiter (n=50) are included. All patients are rendered euthyroid by~     methimazole (MMI) and randomized either to stop MMI eight days before 131I or to be set on~     BRT. This latter medication continues until three months after 131I. Calculation of the 131I~     activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume.~     Patients are followed for one year with close monitoring of the thyroid function.~   "
259731|NCT00150111|"~     Aim:~      In a phase II pilot study encompassing 20 patients with Graves’ disease to evaluate the~     effect of rituximab:~      1. Biochemically as assessed by markers of disease activity ( free T4, free T3, TSH,~     TSH-receptor antibodies, anti-TPO)~   "
259732|NCT00150098|"~     To determine the efficacy of an enhanced HIV risk reduction intervention delivered~     concurrently with a vaccination schedule to reduce the number of unprotected vaginal and anal~     sex acts among HIV-negative, high-risk non-injection drug-using (NIDU) women. To determine~     the efficacy of an enhanced vaccine education intervention delivered at baseline to increase~     vaccine knowledge and understanding of a potential HIV vaccine among HIV-negative, high-risk~     NIDU women.~   "
259733|NCT00150085|"~     New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft~     survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This~     study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to~     cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.~   "
259734|NCT00150072|"~     Preliminary response data, observed by Casali (Cancer, 2004) with imatinib 800 mg/day in~     patients affected by chordoma, need to be confirmed by a Phase II study, whose primary~     endpoint will be the formal assessment of clinical and pathological response. Aim of the~     study will be to explore treatment's activity, but also the potential impact of tumor~     response, the feasibility and outcome of subsequent surgery and radiotherapy. In addition,~     patterns of tumour response need to be investigated as well, given the peculiar patterns of~     response shown with molecular-targeted therapy in solid tumors.~   "
259735|NCT00150059|"~     To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication~     (treatment of patients > 3 months of age with mild to moderate atopic dermatitis)~      This study is not enrolling patients in the United States.~   "
259736|NCT00150046|"~     This study will test the safety and efficacy of everolimus on heart transplant recipients.~      This study is not recruiting in the United States.~   "
259737|NCT00150033|"~     Background:~      Thyroid diseases are frequent. They include both metabolic changes and gland enlargement~     (goitre). Previous research and clinical suspicion indicate that the life quality of many~     patients is reduced despite successful treatment. Research methods are, however, weak, and a~     well-tested, disease specific quality of life questionnaire is especially needed. Several~     treatment possibilities exist for each thyroid disease. For example, hypermetabolism can be~     treated with either medication, radioactive iodine or by surgery. No comparative studies of~     quality of life using the different treatment modalities exist.~      Purpose:~      To develop and evaluate a questionnaire to measure health-related quality of life in patients~     suffering from thyroid diseases.~      Methods:~      To ensure that all relevant aspects are included, the questionnaire will be developed on the~     basis of a systematic examination of the scientific literature and interviews with 13~     physicians and 100 patients. The questionnaire will then be tested by 100 new patients. After~     revision, the questionnaire will be answered by 1000 patients with a view to scientifically~     investigate the measuring capacity of the questionnaire. This will be done using traditional~     psychology methods (psychometry) as well as modern statistical methods (structural equations~     for categorical data and item response models).~      Relevance:~      The above-mentioned questionnaire is necessary for clarifying whether these diseases reduce~     quality of life and, in the long-term, whether a difference in quality of life exists using~     the different treatment alternatives and whether treatment can be improved. It should also be~     included in quality protection studies, in the evaluation of new treatment modalities and~     possibly also in the treatment of the individual patient.~   "
259738|NCT00150020|"~     The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance~     renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse~     events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.~   "
259739|NCT00150007|"~     The purpose of this study is to assess the impact that GI complaints have on patient reported~     outcomes in renal transplant recipients and to determine if there is improvement in patient~     reported outcomes when patients are converted to a EC-MPS-based immunosuppressive treatment.~   "
259740|NCT00149994|"~     The purpose of this study is to determine whether cyclosporine A (in a micro emulsion~     formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or~     superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In~     addition this study will assess the safety and tolerability of a cyclosporine A regimen based~     on C-2h monitoring in comparison to the standard tacrolimus regimen.~   "
259741|NCT00149981|"~     Facilitated access to everolimus until it is commercially available and reimbursable by~     appropriate parties~   "
259742|NCT00149968|"~     The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to~     enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related~     quality of life outcomes, and to determine the proportion of renal transplant recipients who~     are experiencing any GI complaints under MMF-based immunosuppressive treatment.~   "
259743|NCT00149942|"~     This open, single arm, explorative study aims to investigate the evolution of~     gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted~     patients suffering from gastrointestinal adverse events while on MMF therapy.~   "
259744|NCT00149929|"~     Aim of study is to collect long term safety and tolerability data on enteric-coated~     mycophenolate sodium with regard to adverse events, serious adverse events, and patient and~     graft survival. After successful completion of study CERL080A301 study, patients who~     previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to~     remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated~     mycophenolate sodium.~   "
259745|NCT00149916|"~     Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate~     sodium in regard to adverse events, serious adverse events and patient and graft survival.~     After successful completion of the study CERL080A0107 study, patients could continue to~     receive enteric-coated mycophenolate sodium.~   "
259746|NCT00149903|"~     Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared~     to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the~     incidence of biopsy proven acute rejection, graft loss, or death within six months of~     treatment in de novo renal transplant patients.~   "
259747|NCT00149890|"~     Systemic infection is still a major concern in young children with liver transplantation. The~     approach of this study is to reduce the risk of systemic infections by avoiding~     intraoperative steroids (another class of immunosuppressive drugs) given in combination with~     basiliximab, cyclosporine and steroids in pediatric de novo liver transplant recipients. The~     treatment is compared to the same treatment regimen including intraoperative steroids with~     respect to rejection episodes.~   "
259748|NCT00149877|"~     Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of~     subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to~     investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients~     with CC.~   "
259749|NCT00149864|"~     Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720~     mg bid in combination with cyclosporine with/without steroids in regard to adverse events,~     serious adverse events, and patient and graft survival. After successful completion of the~     study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium~     or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF~     to enteric-coated mycophenolate sodium.~   "
259750|NCT00149851|"~     Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric~     (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid~     will cause damage to the esophagus over time. The symptoms of GERD include heartburn and acid~     regurgitation This study will determine if Tegaserod alone and in combination with omeprazole~     is safe and relieves the symptoms of heartburn.~   "
259751|NCT00149838|"~     This study will evaluate the safety and effectiveness of magnetic brain stimulation for the~     treatment of major depression in depressed adults with moderate treatment resistance.~   "
259752|NCT00149825|"~     This study will examine the effectiveness of a combination of antidepressant medication and~     sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.~   "
259753|NCT00149812|"~     This study will assess the effectiveness of the Keeping Families Strong program (KFS) in~     avoiding or delaying the onset of psychiatric disorders among children with depressed~     mothers.~   "
259754|NCT00149799|"~     This study's primary aim is to compare time to relapse and relapse rates in responders to~     acute escitalopram who are then randomized to placebo versus continuation treatment with~     escitalopram.~   "
259755|NCT00149786|"~     This study will compare the effectiveness of family-based therapy versus individual~     psychotherapy for the treatment of adolescent anorexia nervosa.~   "
259756|NCT00149773|"~     This study will assess the effectiveness of cognitive therapy in reducing the incidence of~     suicide ideation and behavior in older men in a primary care setting.~   "
259757|NCT00149760|"~     This study will examine the long-term effect of cognitive-affective behavior therapy on the~     physical symptoms, functioning, and health care utilization of people with somatization~     disorder.~   "
259758|NCT00149747|"~     This study will evaluate the effect of regular aerobic exercise on improving sleep in older~     adults with moderate difficulty sleeping.~   "
259759|NCT00149734|"~     This study will examine the effects of ondansetron on auditory nerve activity in people with~     schizophrenia who are being treated with new antipsychotics.~   "
259760|NCT00149721|"~     Hydrocephalus (secondary or idiopathic) is a condition characterized by dilatation of the~     lateral and third ventricles, and often associated with increased intracranial pressure~     (ICP). We hypothesize that either the ventricle dilatation or the increased ICP may cause~     disturbances in the hypothalamic-pituitary axis, resulting in different degrees of~     hypopituitarism. The goal of this study is to determine the prevalence of hypopituitarism in~     adult patients with hydrocephalus.~   "
259772|NCT00149565|"~     * OBJECTIVES~        1. To investigate whether adjuvant IFN-α therapy can delay or reduce the 2-5 years~          recurrence rate in curatively resected HCC .~        2. To examine whether adjuvant IFN-α therapy can prolong the disease-free survival in~          curatively resected HCC.~        3. To determine the safety and tolerance of adjuvant IFN-α therapy in postoperative HCC~          with or without cirrhosis.~        4. To investigate the change of activity of HBV and HCV in postoperative HCC patients with~          adjuvant IFN-α therapy.~        5. To correlate the changes of viral status with the clinical outcome in post-operative HCC~          patients with adjuvant IFN-α therapy.~   "
259773|NCT00149552|"~     Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this~     study is to determine if zinc therapy will prevent immune failure in HIV infected individuals~     who abuse drugs and have low plasma zinc levels.~   "
263472|NCT00100100|"~     The purpose of this study is to evaluate the efficacy and safety of modafinil in reducing~     cocaine use in subjects with cocaine dependence.~   "
259761|NCT00149708|"~     Growth hormone (GH) deficiency (GHD) in adulthood has been associated with changes in body~     composition (e.g. increased abdominal obesity, and reduced muscle mass), in organ functions~     (e.g. reduced cardiac systolic function), in metabolic parameters linked to increased risk of~     cardiovascular disease (e.g. increased serum total and LDL cholesterol, C reactive protein,~     and plasma fibrinogen), and with reduced bone density. These observations have been used to~     define the adult GHD syndrome and to advocate GH replacement therapy in GHD adults.~     However, most of the studies have been performed in patients who have had hypothalamic or~     pituitary diseases, and/or have undergone brain irradiation. Such patients are often~     chronically sick, and commonly lack other pituitary hormones, whose replacement therapies may~     not fully restore the physiological functions of the under-active glands. Reliable data on~     the existence of the AGHD syndrome and its response to GH therapy can be only obtained by~     studying patients that are otherwise healthy. However, isolated GH deficiency (IGHD) is a~     rare disease. In addition, up to 50% of patients who have been diagnosed with IGHD in~     childhood are no longer GH deficient as adults, making such study difficult to perform due to~     the scarcity of patients population. We have identified a very large homogeneous population~     of patients who have IGHD due to a homozygous mutation in the GHRH-receptor (GHRHR) gene that~     resides in a rural area of Brazil. None of the adult dwarf patients has ever been treated~     with hGH replacement. This population represents a unique model to study the effect of~     isolated lifetime lack of GH. We propose studies of physiological and metabolic parameters in~     subjects who are homozygous for this mutation and compare them with normal subjects residing~     in the same community.~      The primary goal of this proposal is to determine the consequences of life-long lack of GH on~     body composition, muscle strength, cardiovascular status, cardiovascular risk factors,~     thyroid status and bone density and metabolism, and to test which of these parameters are~     reversed by a 6-month course of GH replacement therapy. In addition, we want to test the~     hypothesis that heterozygosity for this GHRHR mutation causes a phenotype that may be~     intermediate between the one present in homozygous normal subjects and in homozygous affected~     GHD patients. This is relevant because inactivating mutations in the GHRHR are being~     described with increasing frequency in populations of different genetic background,~     suggesting that individuals with faulty single GHRHR alleles may be present in significant~     numbers in the general population.~   "
259762|NCT00149695|"~     The primary aim of this randomized controlled trial is to evaluate the effects of replacing~     habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks.~   "
259763|NCT00149682|"~     The purpose of this study is to develop a web-based obesity risk assessment and counseling~     tool and examine its feasibility and effectiveness in improving the rate and quality of~     physician counseling about obesity, dietary change, and physical activity.~   "
259764|NCT00149669|"~     A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic~     Workplace in promoting naltrexone ingestion and abstinence in unemployed opiate-dependent~     injection drug users. Participants will be offered an opioid detoxification and naltrexone~     induction. Participants who complete the naltrexone induction will be randomly assigned to~     one of two groups. Both groups will be invited to work in the Therapeutic Workplace and~     prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to~     work and earn salary. Work Plus Naltrexone Contingency participants will be required to~     ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work~     Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be~     required to ingest it to work. This study will provide a rigorous evaluation of a novel~     employment-based intervention, the Therapeutic Workplace, to promote naltrexone ingestion and~     drug abstinence in a population of injection drug users who are at considerable risk of~     spreading or contracting HIV infection. Hypotheses being tested in this study are: Naltrexone~     ingestion will be maintained in the group exposed to the employment-based naltrexone~     treatment significantly more than the group exposed to usual-care treatment package. Opiate~     abstinence will be maintained in the group exposed to the employment-based naltrexone~     treatment significantly more than the group exposed to usual-care treatment package.~   "
259765|NCT00149656|"~     The purpose of this trial is to determine whether supplementation with multivitamins and~     selenium will delay disease progression in HIV infected individuals in Botswana. The study~     will also assess how drug abuse modifies the effect of nutritional supplementation on HIV~     disease progression.~   "
259766|NCT00149643|"~     Adolescents who are diagnosed with major depressive disorder are often also diagnosed with~     marijuana dependence. Fluoxetine is an antidepressant medication currently used to treat~     young people who are diagnosed with major depressive disorder. The purpose of this study is~     to determine the effectiveness of fluoxetine in treating adolescents and young adults~     diagnosed with both major depressive disorder and marijuana dependence.~   "
259767|NCT00149630|"~     Previous research has shown that disulfiram, a medication sometimes used for treating~     alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone~     treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases~     levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in~     cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug~     relapse among cocaine and opiate addicts with varying inherited levels of DBH.~   "
259768|NCT00149617|"~     This study will assess the effectiveness of a combination of buspirone and motivational~     interviewing therapy in the treatment of marijuana dependence.~   "
259769|NCT00149604|"~     The purpose of this study is to determine whether estrogens specifically promote a reduction~     in fat from abdominal regions during weight loss and/or prevent the accumulation of abdominal~     fat during weight gain.~   "
259770|NCT00149591|"~     The VIAMI-trial investigates the effects of balloon angioplasty with stenting of the~     infarct-vessel in the early phase after acute myocardial infarction. The study concerns~     patients who have residual viable tissue in the infarct-area after being treated with~     thrombolysis. It is postulated that only patients with remaining viable tissue are at~     high-risk for recurrent infarction or anginal attacks and that stenting of the infarct-vessel~     will reduce this risk considerably.~   "
259771|NCT00149578|"~     Induction chemotherapy will be administered every 2 weeks for 6 cycles (about 3 months).~     Patients who have radiological evidence of progressive disease will be shifted to salvage~     chemotherapy. Patients who have responsive or stable disease after induction chemotherapy~     will receive concurrent chemoradiotherapy 3-4 weeks after the last dose of induction~     chemotherapy. Surgical evaluation will be performed 4-6 weeks after the completion of~     chemoradiotherapy. Patients who have resectable disease will undergo surgical resection.~     Postoperative adjuvant chemotherapy with GOFL for 6 cycles will be given for those who have~     curative resection. Patients who still have unresectable disease or non-curative resection~     will receive systemic chemotherapy of GOFL till disease progression or unacceptable toxicity.~   "
259774|NCT00149539|"~     Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to~     buprenorphine in order to limit the abuse potential that is commonly associated with~     buprenorphine. The purpose of this study is to determine the abuse potential of high doses of~     buprenorphine/naloxone in opioid dependent individuals.~   "
259776|NCT00149513|"~     King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS) is a randomized trial for~     individuals who have survived prolonged mechanical ventilation (5 days or more). The~     objective is to enroll individuals who are likely to have impaired health status resulting~     from prolonged critical illness but whose long term prognosis is good. Such individuals are~     most likely to benefit from the study intervention of case management targeted at post~     intensive care complications.~      KCLIP:SOS will test whether an outpatient intervention based on a nurse using a targeted case~     management tool can reduce patient morbidity and improve quality of life in the 6 months~     following hospital discharge. This intervention will be compared to usual post-hospital care.~   "
259777|NCT00149500|"~     We will evaluate the effect of an eighteen-month asthma coaching intervention for~     parents/caregivers of children with asthma to reduce asthma morbidity. The primary objective~     is to determine if asthma coaching will significantly reduce asthma morbidity as measured by~     a reduction in the number of ED visits and hospitalizations for the children during the 18~     months of active coaching and during the 18 months after the coaching stops.~      We will provide half of the subjects (parents/caregivers) with access to assistance from an~     asthma coach for 18 months (including 2 contacts with an asthma nurse during the first 6~     months). The other half of the subjects will not have an asthma coach, but their children~     will have their usual routine care with their primary care providers. The nurse and coach~     will help the subjects learn more about caring for their children's asthma and improving~     interactions with the primary care providers for their children.~   "
259778|NCT00149487|"~     The purpose of this study is to determine the effectiveness of a tailored problem solving~     intervention in increasing adherence to asthma management behaviors in African American~     adolescents with asthma.~   "
259779|NCT00149474|"~     Evaluate the incremental effectiveness of peak flow monitoring ove symptom monitoring as a~     management tool to enhance asthma control in adults >= 50 years with moderate-severe asthma.~   "
259780|NCT00149461|"~     The overall goal of this randomized, controlled study is to compare a model written treatment~     plan with the usual care that is provided by a group of adult and pediatric pulmonologists~     and allergists in their practice settings. The written treatment plan is a form that allows a~     treatment regimen that is consistent with National Heart, Lung, and Blood Institute (NHLBI)~     guidelines to be conveyed to patients. Barriers to the use of written plans will be~     identified to better understand why some patients and physicians use written treatment plans~     more frequently and effectively than others. An additional goal is to assess how patients~     from different racial/ethnic backgrounds utilize treatments plans. Because asthma~     disproportionately affects African American and Latino patients, another goal of this study~     is to better understand if there are fundamental differences in the way patients from~     racial/ethnic minority groups self-manage asthma in comparison to their white counterparts.~     The study will also try to determine if differences exist in the way physicians care for~     minority patients. If there are differences, it is important to determine if the disparities~     can be overcome with the use of a written treatment plan form.~   "
259781|NCT00149448|"~     The broad purpose of this project, proposed by investigators at the University of Alabama at~     Birmingham and the State of Alabama Department of Public Health, is to use a behaviorally~     focused education that has been proven effective to enhance the accuracy and efficiency of~     the contact investigation process. The behaviorally focused intervention will focus on~     enabling public health workers to understand and implement a recently published model of TB~     transmission.~   "
259782|NCT00149435|"~     To support follow-up for the Cardiovascular Health Study (CHS) of coronary heart disease and~     stroke risk factors in adults 65 years or older.~   "
259783|NCT00149422|"~     The purpose of this study is to determine whether NT-proBNP guided treatment of chronic~     congestive heart failure will reduce heart failure related morbidity and mortality compared~     to therapy guided by standard clinical judgement.~   "
259784|NCT00149409|"~     To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as~     regards circulatory function.~   "
259785|NCT00149396|"~     This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of~     the study to determine and evaluate the safety and tolerability of repeated treatments with a~     genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver.~      Stage 2 is to evaluate the dose found in Stage 1 to be optimally tolerated. Stage 2 is to~     assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination~     with second-line chemotherapy.~      Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the~     study.~   "
259786|NCT00149383|"~     The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive~     rosiglitazone in the treatment of uncomplicated P.falciparum malaria.~   "
259787|NCT00149370|"~     Despite the growing evidence showing that breast hypertrophy is associated with reduced~     Health-Related Quality of Life (HRQL) and that reduction mammoplasty has a significant~     positive impact on HRQL, there are unresolved issues that need to be addressed. These include~     our ability to measure quantitatively the change that occurs after reduction and the ongoing~     restriction or denials of third party payments based on body mass index (BMI). The primary~     purpose of this study is to assess and measure the HRQL experienced by breast reduction~     patients using four reliable and validated HRQL measures.~      Fifty-two consecutive patients with the diagnosis of breast hypertrophy were invited to~     participate in this prospective study. Participants completed the Health Utilities Index Mark~     2 (HUI2) and Mark 3 (HUI3) and the Breast Reduction Assessment Value and Outcomes (BRAVO)~     instruments (the Short Form 36, the Multidimensional Body-Self Rating Questionnaire~     Appearance Assessment, and the Breast Related Symptom Questionnaire) at one week and one day~     pre-surgery and one, six, and 12 months post-surgery.~   "
259788|NCT00149357|"~     The purpose of this study is to determine the risk of fetal loss in women with unprovoked~     venous thromboembolism (VTE) who do not have identifiable inherited thrombophilia compared~     with women who have the diagnosis of venous thromboembolism (VTE) excluded.~   "
259803|NCT00149162|"~     The purpose of this study is to evaluate the interest of maintenance treatment with~     interleukin-2 by randomizing the patients being not allogeneic transplanted in complete~     remission after induction and consolidation chemotherapy concerning the event free survival.~   "
259789|NCT00149344|"~     Main research question: Is vertical scar reduction mammoplasty superior when compared to~     inferior pedicle reduction mammoplasty in terms of patient quality of life and~     cost-effectiveness?~      Why is this research important?: There is on-going controversy among plastic surgeons as to~     the superiority of one technique (vertical scar mammoplasty versus inferior pedicle reduction~     mammoplasty) over the other in terms of patient health related quality of life and health~     care resource utilization.~      What is being studied?: We are studying (comparing) two surgical procedures for breast~     reduction mammoplasty (vertical scar mammoplasty versus inferior pedicle reduction~     mammoplasty).~   "
259790|NCT00149331|"~     This study compared the impact of two educational strategies (an education program versus a~     pamphlet) on participants preferences for insulin and their perceptions about insulin and~     injections after attending an educational session with a diabetes educator about insulin.~      Main research question: Among adults with type 2 diabetes who are potential candidates for~     insulin therapy, does an education strategy that involves a personal letter from the family~     physician, a presentation about insulin, and information about giving an injection, versus a~     pamphlet education strategy, effect: preference to accept insulin therapy; perceptions about~     insulin therapy; or perception about the injection?~   "
259791|NCT00149318|"~     Fabry disease is an X-linked rare metabolic disease, caused by a deficient activity of the~     hydrolase α-Galactosidase A, and characterized by a progressive and systematic deposition of~     glycosphingolipids in many organs.~      The disease is most severe in affected males. In the classic form (where the enzyme activity~     is absent) the clinical findings are represented by pain and paresthesias in the extremities,~     vessel ectasia (called angiokeratoma) in skin and mucous membranes, and hypohidrosis (a~     reduced sweating) during childhood or adolescence. Corneal and lenticular opacities may be~     present. Proteinuria, renal impairment,cardiac and neurological lesions develop with time,~     together with hypertension. When end stage renal disease occurs, dialysis or renal~     transplantation may be necessary. In heterozygous females a residual enzymatic activity may~     be demonstrated and they usually have asymptomatic or later onset disease manifestations,~     although rarely they could develop a disease as severe as in males.~      A cardiac and a renal variant, where the heart and kidney are the only organs involved by the~     disease have been described too.~      The recombinant human α-galactosidase A is now available for patients. Infusions of the~     enzyme replacement treatment have been demonstrated to be safe and effective. This study~     wants to evaluate the long term efficacy of enzyme replacement therapy in patients with Fabry~     disease and renal involvement.~      Clinical period evaluations together with a genetic counselling will be offered to each~     patient.~   "
259792|NCT00149305|"~     Gouty diathesis describes uric acid or calcium oxalate nephrolithiasis and low urinary pH~     (<5.5). A hereditary component has been outlined for several forms of nephrolithiasis (such~     as hypercalciuria, hyperoxaluria, cystinuria, renal tubular acidosis), leading to the~     hypothesis of a genetic predisposition to nephrolithiasis. At the Unit of Nephrology,~     Ospedali Riuniti di Bergamo, more than 100 patients affected by gouty diathesis are followed.~     Fifty percent of them has a familiarity for kidney stones formation. The aim of our study is~     to identify the genetic factors that predispose to the development of nephrolithiasis in~     patients with gouty diathesis.~   "
259793|NCT00149292|"~     Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic~     activity) in the treatment of schizophrenia.~      The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is~     superior to placebo in the treatment of patients with schizophrenia as measured by the~     Positive and Negative Symptom Scales (PANSS) total score.~   "
259794|NCT00149279|"~     To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative~     gastrectomy~   "
259795|NCT00149266|"~     To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia~     or subcardia cancer~   "
259796|NCT00149253|"~     Taken together, studies of the value of pre-emptive analgesia are inconclusive. This~     randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to~     test that a reduction in post-operative morphine consumption can be achieved by a single-dose~     of etoricoxib before induction of anesthesia.~   "
259797|NCT00149240|"~     The main purpose of this study is to determine the effectiveness and safety of one dose of~     botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in~     patients with a type of back pain called primary myofascial pain syndrome.~   "
259798|NCT00149227|"~     The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor~     Blocker, on top of the conventional treatment in high risk patients in Japan with~     hypertension in terms of the morbidity and mortality.~   "
259799|NCT00149214|"~     An open-label randomized Phase II study in order to explore two different sequential~     anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable~     breast cancer (T2-T4/N0-2/M0).~   "
259800|NCT00149201|"~     To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis~   "
259801|NCT00149188|"~     The purpose of this study is to allow patients with acromegaly, or their partners, to learn~     how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised~     injections whilst maintaining adequate disease control will be assessed.~   "
259802|NCT00149175|"~     Patients with different types of dementia will be recruited and evaluated in national~     hospital departments for their usual neurological follow-ups. A blood sample will be proposed~     in the field of this research project, and the biological material will be stored at the DNA~     and Cell Bank of Institut de Fédératif Recherche (IFR) of Neurosciences (Pitié-Salpêtrière~     Hospital, Paris). The clinical research network is already set up for Alzheimer's disease and~     frontotemporal dementias, which permits an evaluation according to a clinical standardized~     protocol.~      Among these disorders, a monogenic sub-group has been identified. In Alzheimer's disease, it~     is associated with the APP, PSEN1 and PSEN2 genes, which account only for 75% of the familial~     forms with early onset. In frontotemporal dementias, the tau gene mutations account only for~     10% of the cases with an autosomal dominant inheritance. The identification of familial forms~     with a genetic inquiry in the relatives is essential for a greater knowledge of the molecular~     bases of forms not caused by the known genes, using linkage approaches and candidate gene~     analysis. The familial forms are also useful for identifying the modifier genes.~      In the multifactorial forms, the aim is to assemble a wide cohort of patients and controls~     matched for localizing and identifying susceptibility genetic factors. The strategies will~     use a candidate gene approach, and in the near future, studies of single nucleotide~     polymorphisms (SNPs) spread out in the whole genome. Meanwhile, similar approaches,~     particularly with candidate genes, could be used for identifying predictive factors of~     tolerance and response to the treatment.~      Finally, correlations will be performed with seric markers according to each kind of~     dementia.~      Specialized clinical teams in diagnosis and follow-up in dementias are assembled for this~     project, and in the study of neurological disorders of genetic origin.~   "
259804|NCT00149149|"~     Zinc carnosine is a food supplement which is available in the health food shops. The~     investigators wish to see if it can reduce intestinal swelling in people who take~     non-steroidal anti-inflammatory (anti-swelling) drugs (NSAIDs).~   "
259805|NCT00149136|"~     ALL patients aged 55 years or older were treated with steroids during one week and Ph+ve~     cases were then offered a specific therapy including an induction treatment with steroids,~     cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to~     induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during~     2 months. Patients in complete response (CR) were then given 10 blocks of alternating~     chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment~     duration of 2 years. Therapy of occult central nervous system leukemia included 5 intrathecal~     injections of methotrexate and cranial irradiation.~      Duration of therapy : 2 years.~   "
259806|NCT00149123|"~     Major burns trigger the release of circulating mediators, as cytokines and endotoxin that~     induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to~     those seen in septic shock. After the initial hypovolemic phase, patients with extensive~     burns often present a shock with increased cardiac output and reduced systemic vascular~     resistances. As described in septic shock, we test the hypothesis that low-dose~     hydrocortisone could decrease the duration of the shock period.~   "
259807|NCT00149110|"~     The primary objective of the present study is to examine whether the combination of the~     antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light~     therapy, and maintaining a regular sleep-wake rhythm) in patient with major depression, will~     induce an immediate improvement from depression and whether this antidepressive effect will~     be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned~     treatment or to an active group receiving exercise.~   "
259808|NCT00149097|"~     The study aims to characterise the influence of the autonomic nervous system activity on the~     development of the lipodystrophy syndrome in HIV-infected patients by measuring heart rate~     variability and various metabolic pathways in HIV patients receiving highly active~     antiretroviral therapy.~   "
259809|NCT00149084|"~     The eradication rate of the standard H. pylori eradication therapy (such as the triple~     therapy with a proton pump inhibitor [PPI], amoxicillin and clarithromycin) depends on~     bacterial susceptibility to clarithromycin and genotypes of CYP2C19 in patients. The~     investigators intend to investigate whether the tailored therapy based on the two~     above-mentioned factors increases the cure rate of the initial eradication therapy.~   "
259810|NCT00149071|"~     A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram~     in patients with prior treatment resistant depression in an acute 12 weeks trial with~     subsequent 24 weeks study phase with active versus placebo citalopram~   "
259811|NCT00149058|"~     Erythropoietin (EPO) is a naturally occuring hormone which regulates the body's response to~     lack of oxygen and controls the number of red cells in the blood. Recent studies in animals~     have shown that EPO has protective effects when organs such as the heart and brain are~     injured by lack of oxygen due to reduced blood supply.~      We wish to test the idea that giving a patient, who is having a heart attack, an injection of~     EPO will reduce the size of the heart attack.~   "
259812|NCT00149045|"~     The study is aimed to test the hypothesis that there is anticipation in CMT~   "
259813|NCT00149032|"~     Allogeneic stem cell transplantation is the only effective treatment to patients resistant to~     conventional chemotherapy. Donor lymphocytes infusion (DLI) serve as a routine treatment of~     choice for patients relapsing following allogeneic stem cell transplantation. The present~     proposal is presented for introducing the use of immune rather than naive donor lymphocytes~     for patients with resistant relapse and resistant to DLI. DLI primed in-vitro against tumor~     cells of host origin or against host alloantigens presented by parental alloantigens in one~     way mixed lymphocytes culture can induce much more than potent graft-vs-leukemia and~     graft-vs-tumor effects, while down-regulating graft-vs-host disease (GVHD).~   "
259814|NCT00149019|"~     Patients with resistant metastatic solid tumors failing all conventional modalities who are~     eligible for immunotherapy by bispecific antibodies.~      First step: NST Second step: Patients with tumor cells expressing positive Her-2Neu and/or~     EpCAM with residual or recurrent disease following NST will be candidates for donor~     lymphocytes immunotherapy using bispecific antibodies.~      Patients with no matched donor available, expressing positive Her-2Neu and/or EpCAM tumor~     cells, will be eligible for donor mismatched lymphocytes using in-vitro rIL-2 activated~     allogeneic lymphocytes targeted to the tumor by bispecific antibodies, Her-2Neu and/or EpCAM.~   "
259815|NCT00149006|"~     The present protocol is designed to investigate the potential application of allogeneic~     cell-mediated immunotherapy in metastatic solid tumors similarly to the well established~     graft versus leukemia (GVL) effects in patients with hematologic malignancies.~      Patients with metastatic solid tumors resistant to conventional modalities will be eligible~     to participate in a treatment program based on the administration of non-myeloablative~     immunotherapy (i.e. fludarabine, Cytoxan) followed by interferon injections; subsequently the~     patients will be treated with mismatched alloreactive donor lymphocytes activated in vitro~     and in vivo with rIL-2. The aim of this study is based on the recognition of foreign tumor~     cell surface alloantigens.~   "
259816|NCT00148993|"~     The goal of this study is to apply allogeneic tumor cell vaccination for immunotherapy in~     patients with micro-metastatic disease and/or in patients at high risk disease progression.~     The present study will use allogeneic tumor cell lines for tumor cell vaccines that share MHC~     determinants with the patient aiming to overcome possible restriction of antigen~     presentation.~   "
259847|NCT00148577|"~     We aimed to establish the reduction of labor pain by applying TENS at acupuncture points~     during the first stage of labour, to assess their efficacy, and to ascertain their~     acceptability.~   "
259848|NCT00148564|"~     The purpose of this study is to evaluate the effects of different atypical antipsychotics on~     weight changes, energy homeostasis, metabolism, energy intake as well as activity.~      Patients with schizophrenia or schizoaffective disorders will be randomly assigned to be~     treated with ziprasidone or olanzapine for 24 weeks.~      Primary outcome parameter are the weight changes after 24 weeks.~   "
259849|NCT00148551|"~     A 24 - month Study looking at the the changes in visual acuity of patients receiving PDT~     therapy in conjunction with intravitreal triamcinolone.~   "
259817|NCT00148980|"~     Normal bone marrow function depends on the coexistence of normal hematopoietic stem cells and~     a microenvironment mostly located in the medullary part of the bones. Stem cells cannot~     function properly in the absence of an adequate microenvironment. Whereas in malignant and~     non-malignant hematologic diseases caused by a deficiency or abnormal stem cells, stem cell~     transplantation is the treatment of choice that results in a cure, in diseases such as MDS,~     myelofibrosis, and other conditions associated with an abnormal microenvironment,~     pancytopenia may occur despite the presence of apparently normal hematopoietic cells with no~     recognizable cytogenetic abnormality.~      We, the investigators at Hadassah Medical Organization, proved in experimental studies that~     the entire osteohematopoietic complex consisting of trabecular bone, hematopoietic~     microenvironment (of stromal origin) and hematopoietic tissue has been successfully~     transferred directly into ablated bone marrow cavity in a one-step transplantation procedure.~      The goal of this study is to enhance hematopoiesis in patients with myelofibrosis syndrome by~     intraosseous inoculation of demineralized bone matrix (DBM) together with allogeneic bone~     marrow cells (BMC).~   "
259818|NCT00148967|"~     INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative~     dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.~   "
259819|NCT00148954|"~     RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy~     of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected~     Medtronic ICDs.~   "
259820|NCT00148941|"~     The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK~     Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate~     non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and~     safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine~     [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP~     and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines~     will be co-administered with the second dose of M-M-RII, which is recommended at this age.~     Concomitant administration of a US-licensed influenza vaccine will be allowed according to~     seasonal availability of vaccine and at the discretion of the investigator.~   "
259821|NCT00148928|"~     Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor~     treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will~     be 16 vaccinations, given over a period of approximately one year. Thereafter, the patients'~     long-term safety and PSA status will be followed over a period of approximately 11 months.~   "
259822|NCT00148915|"~     The purpose of this randomized, double-blind, placebo-controlled study is to estimate the~     effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality~     and strength at the proximal femur at one year.~   "
259823|NCT00148902|"~     This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).~   "
259824|NCT00148889|"~     The purpose of this study is to investigate the efficacy and safety of bilateral pallidal~     stimulation in patients with medically refractory primary cervical dystonia.~   "
259825|NCT00148876|"~     This study is done in patients having Breast Cancer with metastasis (patients with positive~     receptor HER2) whose disease progressed after receiving Trastuzumab.~      The primary objective of this study is to compare the time until disease progression between~     the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB~      The study has also other secondary and tertiary objectives.~   "
259826|NCT00148863|"~     Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no~     treatment recommended for non responders patients. This study will evaluate the efficacy,~     after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the~     addition of interferon gamma in non responders patients~   "
259827|NCT00148850|"~     The aim of this randomized study is to compare the effect of pioglitazone versus placebo on~     change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at~     least 6 months and with clinical lipoatrophy.~   "
259828|NCT00148837|"~     Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of~     developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to~     make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.~   "
259829|NCT00148824|"~     Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients.~     The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count~     lower than 500/mm3. This study will test the efficacy and safety of a new pneumococcal~     vaccine strategy in patients with a CD4 cell count between 200 and 500/mm3.~   "
259830|NCT00148798|"~     The purpose of this trial is to investigate the efficacy of cetuximab in combination with~     chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell~     lung cancer who did not received prior chemotherapy. Overall survival will be taken as~     primary measure of efficacy.~   "
259850|NCT00148538|"~     This is a randomized controlled trial evaluating different exercise modalities in previously~     inactive subjects with type 1 diabetes.~      The primary objective of this study is to determine the effects of resistance exercise~     training, and of aerobic exercise training, on glycemic control (A1c) in previously inactive~     individuals with type 1 diabetes, with background therapy meeting modern standards, including~     multiple daily insulin injections or insulin pump, carbohydrate counting, frequent glucose~     monitoring, and utilization of glucose monitoring to adjust CHO and insulin for exercise.~      Secondary aims: In type 1 diabetic individuals receiving therapy meeting the criteria above,~     to determine the effects of resistance exercise training and aerobic exercise training on~     frequency of hypoglycemia, body composition, lipids, C-reactive protein and quality of life.~      Hypotheses:~        1. Subjects randomized to resistance exercise (R and AR combined) will have greater~          reductions in A1c than in those not randomized to resistance exercise (A and C~          combined).~        2. Subjects randomized to aerobic exercise (A and AR combined) will show a trend to greater~          HbA1c reduction than those not randomized to aerobic exercise (R and C combined).~      Secondary hypotheses: We expect that both aerobic and resistance exercise will show trends to~     improvement in most listed secondary outcomes.~   "
259892|NCT00147992|"~     This study is an evaluation of the survival of the implants and bridges, quality of~     prosthetic work and patient satisfaction after immediate loading of the implants in a totally~     edentate upper and lower jaw.~   "
259831|NCT00148785|"~     When individuals who are infected with HIV are started on treatment with HIV medications, the~     effect of these drugs only lasts for a limited period of time, often because of development~     of drug resistance by the HIV virus. When this happens, such patients have to be switched to~     different combinations of HIV medications. However, since the availability of new HIV drugs~     that are active against resistant virus is limited, HIV care providers are resorting to~     curtail medications that contain three or more protease inhibitors (PIs). The reason for this~     is Norvir (ritonavir), a PI that has the ability to boost or increase the blood levels of~     other PIs in a way that can sometimes overcome the resistance of HIV virus. In addition, it~     may be more difficult for the virus to overcome two or more drugs with high blood levels,~     than it is to overcome just one. For these reasons, many clinicians are now using Norvir in~     combination with two other PIs, including Crixivan (indinavir) plus Lexiva (fosamprenavir),~     for treating patients who have been exposed to many other HIV medications.~      While this may be the case, researchers also know that when two or more PIs are combined, the~     effects each drug may have on the blood level of other drugs could be different. For example,~     researchers know from some recent studies that the combination of Norvir, Lexiva, and~     Kaletra, another PI, leads to an unacceptably low level of both Kaletra and Lexiva. Because~     researchers can not always assume that when multiple HIV medications are combined, the levels~     will remain high enough to be effective, the investigators think it will always be reasonable~     that, before any combination of drugs are used on HIV-infected patients, the effect a~     combination has on the levels of each of the drugs in the combination should be investigated.~      AIMS: The aim of this pilot study therefore is to examine the blood levels of Crixivan,~     Lexiva, and Norvir when these three drugs are used together as part of a combination~     treatment for HIV infection.~      METHODS: Fifteen (15) HIV-infected volunteers already being treated with a Crixivan and~     Norvir containing regimen will be recruited from the Grady Infectious Disease Clinic (IDP).~     Lexiva will be added to this regimen for 5 days, at the end of which participants will be~     admitted to the Grady General Clinical Research Center (GCRC) where blood samples will be~     collected at 9 different time points over 12 hours for measurement of blood drug levels.~      Pharmacokinetic Analysis: The blood concentrations of Crixivan, Lexiva, and Norvir will be~     measured by a special technique known as reverse-phase high-performance liquid chromatography~     with ultraviolet detection.~      Statistical Analysis: The blood level information will be summarized by a statistical method.~     The researchers will then compare the levels of Lexiva in this combination with historically~     published levels of Lexiva in a study of Lexiva plus Norvir; and that of Crixivan in a study~     of Crixivan plus Norvir. A difference of 30% or more in drug levels between this study and~     historical reports will be considered a significant difference.~   "
259832|NCT00148772|"~     The primary objective of this study is to evaluate the effect of erlotinib on the PSA~     response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen~     deprivation therapy.~      The secondary objectives are to evaluate the effect of erlotinib on the duration of PSA~     response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of~     erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with~     various epidermal growth factor receptor (EGFR)-related proteins using baseline~     immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.~   "
259833|NCT00148759|"~     The levels of lopinavir achieved in the blood following oral ingestion of standard doses of~     Kaletra (lopinavir/ritonavir) in HIV-infected men was compared with those achieved in~     HIV-infected women receiving the same dose of the drug.~   "
259834|NCT00148746|"~     The study was designed to test the hypothesis whether a standardized, time-and score-oriented~     treatment following a strict evidence based algorithm is equally effective to a standard~     treatment regimen for moderate to severe atopic dermatitis.~      Study Type: Mono-centre study, patients are blinded, physicians are randomized to either~     treat study- or controll group~      Eligible are patients age 2 years or older with SCORAD >= 20 Duration: 12 Months, study~     visits every 4 weeks.~      Primary endpoint is Difference between Baseline SCORAD and mean SCORAD under treatment.~      Secundary endpoints are quality of life, safety and economic burden in both treatment groups.~   "
259835|NCT00148733|"~     The aim of the study described is to measure the degree with which zinc given as adjunct~     therapy to standard antibiotic treatment during childhood pneumonia reduces the risk of~     treatment failure and the duration of the illness.~   "
259836|NCT00148720|"~     The purpose of this study is to find out what effects (good and bad) taking capecitabine for~     12 weeks before surgery will have on women with breast cancer.~   "
259837|NCT00148707|"~     The purpose of this study is to collect information on what effects (good or bad) CT-2103~     (Xyotax) has on breast cancer as well as any side effects the drug may cause.~   "
259838|NCT00148694|"~     The purpose of this study is to find out what effects the preoperative therapy cisplatin will~     have on patients with early stage estrogen receptor-negative (ER-), progesterone~     receptor-negative (PR-), or HER-2 negative breast cancer.~   "
259839|NCT00148681|"~     The purpose of this study is to find out what effects the preoperative combination therapy of~     herceptin and navelbine have on HER-2 positive breast cancer.~   "
259840|NCT00148668|"~     The purpose of this study is to find out what effects the preoperative combination therapies~     of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early~     stage HER-2 positive breast cancer.~   "
259841|NCT00148655|"~     The purpose of this study is to determine whether adding an educational intervention, in the~     form of a decision board, which outlines the risks and benefits of treatment options for~     DCIS, at the time of the first surgical consultation will improve decision making for women~     with DCIS.~   "
259842|NCT00148642|"~     The purpose of this study is to determine if the use of a silver-coated endotracheal tube~     (ETT) can reduce the incidence and/or delay the time of onset of VAP when compared to a non~     silver-coated ETT in patients who have been mechanically ventilated for >= 24 hours.~   "
259843|NCT00148629|"~     The purpose of this research is to compare the efficacy of two low-cost low intervention~     packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two~     packages are Standard of Care as described by the WHO (presumptive treatment for malaria and~     helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus~     daily multivitamins and a 2nd dose of anthelminthic.)~   "
259844|NCT00148616|"~     The purpose of this study is to evaluate the efficacy and safety of memantine as add-on~     treatment for the treatment of negative symptomatology and cognitive impairment in patients~     with chronic schizophrenia.~      Primary outcome parameter are changes in negative symptoms between baseline and 6 months~   "
259845|NCT00148603|"~     This is a single site study of the effect of montelukast on eosinophil and mast cell counts~     and activation in the lining of the duodenum in 24 children with dyspepsia in association~     with duodenal eosinophilia in association with measuring the concentration of the medication~     in the lining of the duodenum. Patients will be endoscoped with biopsies obtained from the~     duodenum as part of routine clinical care. Participants in the study will then receive~     montelukast daily and the endoscopy with biopsies will be repeated on day 21 to measure cell~     counts and activation and tissue montelukast levels. Cell counts and measures of activation~     will be compared to pre-treatment levels.~   "
259846|NCT00148590|"~     The purpose of this study is to evaluate the efficacy and safety of memantine as add-on~     treatment for the prevention of negative symptomatology in patients with an acute~     exacerbation of schizophrenia.~      Primary outcome parameter are negative symptoms after 6 months~   "
259851|NCT00148525|"~     The purpose of this study is to test two different approaches to helping individuals who have~     recently starting eating a healthful diet maintain those healthy changes. This study will~     deliver a health program using an automated telephone system. The programs will be designed~     to help individuals maintain a healthy diet change for a lifetime.~   "
259852|NCT00148512|"~     The primary objective of this exploratory study is to investigate the efficacy and safety of~     tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week~     treatment period in levodopa treated Parkinson patients with motor fluctuations.~   "
259853|NCT00148499|"~     The purpose of this trial is to investigate efficacy and tolerability of lozenges containing~     20 mg a mbroxol hydrochloride (Mucoangin?) relative to lozenges containing placebo and~     lozenges containing 3 mg benzocaine in relieving pain of sore throat in patients suffering~     from acute viral pharyngitis.~   "
259854|NCT00148486|"~     To demonstrate efficacy and dose-response of NS 2330 versus placebo in patients with early~     Parkinson's Disease in 14 weeks of treatment, and to investigate the safety and tolerability~     of NS 2330 in these patients.~   "
259855|NCT00148473|"~     The purpose of this study is to compare the efficacy between a single dose of oral~     misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.~   "
259856|NCT00148460|"~     The objective of this trial was to compare the efficacy and safety of a single bolus of~     TNK-tPA (tenecteplase, Metalyse®) compared with rt-PA (alteplase, Actilyse®) in Asian~     patients.~   "
259857|NCT00148447|"~     The aim of this study is to evaluate the therapeutic effect of escitalopram in the treatment~     of negative symptoms in schizophrenia patients in a double-blind placebo-controlled study.~   "
259858|NCT00148434|"~     While patient held guidelines for the management of chronic diseases have been employed in~     some countries. There is little evidence of their effectiveness in improving patient~     outcomes. We hypothesised that a patient held guideline on the management of hypertension~     combined with a specific exhortation to patients to challenge their medical care where the~     guidelines did not appear to have been applied would improve blood pressure control, lower~     average blood pressure, lower average cholesterol, increase the appropriate use of statins~     and aspirin, and have no impact on patient anxiety. Patients were randomised to the guideline~     or to standard hypertension information. Measures of anxiety were taken at baseline 2 weeks~     and one year, blood pressure and cholesterol was measured at one year and case notes examined~     to determine appropriate statin and aspirin usage.~   "
259859|NCT00148421|"~     Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle~     chemotherapy.~   "
259860|NCT00148408|"~     The purpose of this research study is to investigate the way that educational approaches and~     presentation of a drug may affect the response to montelukast and placebo (an inactive~     medication) in subjects with asthma.~   "
259861|NCT00148395|"~     This study wants to assess different intensive therapy sequences for the treatment of~     non-small-cell lung cancer.~      It claims less on the efficacy of different chemotherapy combinations, than more on the~     comparison of different strategies of sequential single-agent, sequential double-agent or~     sequential triple-agent therapy.~   "
259862|NCT00148382|"~     The purpose of this study is to investigate the amount of metabolites of ATL-962 in the blood~     and to investigate the effect of ATL-962 on the amount of fat that is excreted in the faeces~     in subjects who are obese~   "
259863|NCT00148369|"~     The primary purpose of this study is to evaluate clinical and serologic outcomes after the~     discontinuation of liatermin therapy as assessed by development of new clinical conditions~     beyond those expected in patients with advancing Parkinson's disease. In addition, the~     development or resolution of anti-r-metHuGDNF binding and neutralizing antibodies will be~     monitored.~   "
259864|NCT00148356|"~     The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx~     drug-eluting stent in patients with blockage of native coronary arteries. The study is~     designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that~     has proven superior to bare metal stents and is a recognized standard of care.~   "
259865|NCT00148343|"~     The objective of this research is to determine if electrical stimulation can improve the~     strength and coordination of the lower limb muscles, and the walking ability of stroke~     survivors.~      The knowledge gained from this study may lead to enhancements in the quality of life of~     stroke survivors by improving their neurological recovery and mobility. The results may lead~     to substantial changes in the standard of care for the treatment of lower limb hemiparesis~     after stroke.~   "
259866|NCT00148330|"~     This open label extension will treat all the eyes of study participants with active study~     medication (intravitreal triamcinolone) as well as standard laser treatment where~     appropriate.~      The specific aims will be to test the following hypotheses:~        -  That intravitreal triamcinolone for diabetic macular oedema that persists or recurs~          after laser treatment remains efficacious over five years~        -  That intravitreal triamcinolone for diabetic macular oedema that persists or recurs~          after laser treatment retains a manageable and acceptable safety profile over five years~   "
259867|NCT00148317|"~     PRIMARY STUDY OBJECTIVES~        -  To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and~          without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different~          subsets of multiple myeloma patients:~             1. Patients post first line therapy~             2. Patients with relapsed/refractory disease who are bortezomib-naïve~        -  To evaluate the safety of the combination of bortezomib and dexamethasone, with and~          without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with~          multiple myeloma.~      SECONDARY STUDY OBJECTIVES~        -  To evaluate the role of the combination of bortezomib dexamethasone, with and without~          DOXIL, followed by high-dose cyclophosphamide on the ability to collect > 10 x 106 CD34+~          cells/kg in < 7 collections (for both subsets of multiple myeloma patients).~        -  To evaluate the survival of patients who receive the combination of bortezomib~          dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both~          subsets of patients).~   "
259868|NCT00148304|"~     The purpose of this study is to better understand disparities in insulin dosing, hemoglobin~     A1c, and self-reported patient self-care behaviors among non-Hispanic white, Hispanic, and~     African American veterans with type 2 diabetes receiving VA care.~   "
259869|NCT00148291|"~     Vinorelbine is currently the standard treatment for elderly patients with advanced non-small~     cell lung cancer (NSCLC). Docetaxel has also shown promising results against elderly patients~     in phase II studies. We conducted a randomized phase III trial to evaluate whether docetaxel~     provided better overall survival than vinorelbine in elderly patients with advanced NSCLC.~   "
259870|NCT00148278|"~     Catecholamines infusion is a major component of septic shock management. International~     guidelines recommend that norepinephrine should be preferred to epinephrine, though phase III~     trials are lacking. The present study aimed at comparing the efficacy and safety of~     norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.~   "
259871|NCT00148265|"~     This study is likely to identify an improved and economical treatment for diabetic macular~     oedema, one of the commonest causes of blindness both in Australia and the rest of the~     world.The specific aims of the study are to test the following hypotheses:~        -  That intravitreal triamcinolone followed by laser treatment results in a greater~          improvement in visual acuity than placebo followed by laser treatment of eyes with~          macular oedema secondary to diabetes;~        -  That intravitreal triamcinolone followed by laser treatment results in greater degree of~          resolution of macular oedema than placebo followed by laser treatment of eyes with~          macular oedema secondary to diabetes;~        -  That intravitreal triamcinolone followed by laser treatment results in a reduced~          requirement for further laser treatment to control diabetic macular oedema than placebo~          followed by laser treatment;~        -  That intravitreal triamcinolone followed laser has a manageable and acceptable safety~          profile in eyes with diabetic macular edema.~   "
259872|NCT00148252|"~     To compare the change in renal function between CsA or MMF withdrawal from before to 12~     months after drug withdrawal in renal transplant recipients on triple immunosuppressive~     therapy~   "
259873|NCT00148239|"~     The overall objective of this project is to test the efficacy of an innovative~     multi-component intervention aimed at reducing the risk for adverse health outcomes among~     caregivers of older survivors with spinal cord injury or disability, and to improve the well~     being of the spinal cord-injured survivor. In a three-group, randomized, controlled design~     providing access to information, resources, and support, we predict that the dual target~     approach will have a greater positive impact on both the caregiver and survivor than the~     caregiver-only approach, and that both active treatments will be superior with respect to~     caregiver outcomes than an information-only control condition.~   "
259874|NCT00148226|"~     This project has been completed and consisted of a randomised trial of six tailored decision~     aids giving patients evidence-based information about faecal occult blood test screening for~     bowel cancer. 314 Australians aged between 50-74 years were recruited from five general~     practices and randomised to received either the tailored decision aid with age-gender and~     family history specific information and values clarification exercise or a standard~     government information sheet.~      The decision aid significantly increased the proportion of people who were informed~     participants in the screening program.~   "
259875|NCT00148213|"~     Human thyroglobulin (Tg) is the most sensitive biochemical marker for recurrence of~     differentiated cancer (DTC), especially after the complete removal of thyroid tissue through~     surgery and radioiodine therapy (RIT).~      Unfortunately, current assays for measuring Tg in blood samples are not sensitive enough to~     reliably measure Tg while patients are under thyroid hormone replacement therapy. Instead~     patients have to withdraw thyroid hormone for several weeks or receive costly injections of~     recombinant thyroid stimulating hormone (TSH) in order to raise Tg production by thyroid~     remnant and/or thyroid cancer cells so that it can be measured by current Tg assays. Other~     patients have antibodies against Tg that interfere in current immunoassays.~      The purpose of the study was to characterize a new highly sensitive assay for measuring Tg in~     the serum in thyroid cancer patients both on thyroid hormone therapy and off therapy in~     comparison to the normal routine assay already in use at Münster University Hospital.~   "
259876|NCT00148200|"~     Purposes of this study are:~        -  To determine the prevalence of female sexual dysfunctions among Italian general~          population~        -  To determine which sexual domains are more frequently compromised~        -  To evaluate which of the factors we took into consideration are more frequently~          associated with FSD~   "
259877|NCT00148187|"~     The purpose of this study is to quantitate pre-transplant medication compliance, dialysis~     compliance, and related psychological variables, and then examine their validity as~     predictors of post-transplant noncompliant behaviors and clinically relevant outcomes (acute~     rejection, graft loss, or death).~      Hypothesis: Noncompliance with pre-transplant medication or with the dialysis prescription,~     and specific psychological variables predict similarly noncompliant behaviors after~     transplantation.~   "
259878|NCT00148174|"~     This is a randomized controlled intervention trial in poorly compliant patients, testing~     whether improved compliance behavior decreases rates of acute rejection risk and graft loss.~      Hypothesis: A study of an intensive intervention focused on the least compliant patients and~     beginning 3 months post-transplant. Effective intervention will reduce the number of acute~     rejection episodes and thus the occurrence of chronic rejection and graft loss.~   "
259887|NCT00148057|"~     This randomized controlled trial tests the hypothesis that a reduction in intake of dietary~     fat will reduce the incidence of breast cancer. Women with more than 50% of the breast~     occupied by dense tissue on a mammogram have been recruited and allocated by a random (ie~     chance) process, to an intervention or control group. The intervention group has been taught~     how to reduce their fat intake to a target of 15% of total calories, while the control group~     continued their usual consumption of fat. Both groups have then been followed for at least 7~     years and the number who develop breast cancer in each group will be compared~   "
259888|NCT00148044|"~     Determination of the concentration of uremic toxins of sepsis patients with or without acute~     kidney failure compared to the concentrations of uremic toxins of chronically uremic patients~   "
259889|NCT00148031|"~     The overall goal of the research project is to improve the outcome of medical care for~     injection drug users (IDUs) with Hepatitis C viral (HCV) infection.~      Hypothesis: An intervention designed to improve the rate of HCV treatment completion and~     sustained virologic response (SVR) in IDUs will increase access by integrating HCV medical~     care into a substance abuse treatment program.~   "
259890|NCT00148018|"~     The primary objective of this study is to evaluate wether bortezomib and dexamethasone are~     active in patients with relapsed Hodgkin's lymphoma.~   "
259879|NCT00148161|"~     The goal of the study is to examine the cortical activity during speech perception and speech~     production in idiopathic stutterers compared to fluent speakers. Therefore, the noninvasive~     method of magnetoencephalography (MEG) is used. A better understanding for the complexity of~     speech perception and its pathology should be developed.~      Fundamental properties of stuttering are repetitions, prolongations, and blocks. In most~     cases stuttering emerges between 2 and 5 years of age. The auditory feedback should become~     less important during development, as soon as information about mispronounced words does not~     occur anymore. During speech development this control function should be adopted by other~     systems. In stutterers the dominance of the acoustic control should remain.~      Brain imaging studies with positron emission tomography (PET) or magnetic resonance imaging~     (MRI) show defects in the network of motor system, in the lateralization of speech areas, and~     functions of the auditory cortex. Magnetoencephalographic studies describe a similar variety~     as cause of stuttering. There may be defects in the auditory feedback, a modification of the~     lateralization of speech areas, or an alteration of co-action of motor planning and auditory~     system.~      The benefit of magnetoencephalography is a very good temporal resolution in the range of~     milliseconds combined with good spatial resolution. Therefore, it is well suited to examine~     the dynamics of cortical processing during stuttering. In this study evoked components of the~     auditory systems related to complex sounds, vocals, consonant-vocal combinations, and single~     words are analyzed. Differences of these components in the auditory cortices of stutterers~     and fluent speakers are hypothesized as well in temporal structure as in localization and~     lateralization.~   "
259880|NCT00148148|"~     The study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal~     amphotericin B or the combination of both in the antifungal treatment of adult patients after~     allogeneic haematopoietic stem-cell transplantation with granulocytopenia and persistent i.g.~     recurrent fever under adequate antibacterial therapy.~   "
259881|NCT00148135|"~     This study is for patients with a type of cancer called carcinoma of unknown primary site~     (CUP), meaning that the site of the body where the tumor has originated is not clear.~     Currently, carcinoma of unknown primary site (CUP) accounts for about 5% of all newly~     diagnosed malignancies. The stage of the tumor is such that it is not treatable by surgery.~     Currently, the standard treatment for such a type of cancer at that stage is chemotherapy.~     However, the overall prognosis for patients with metastatic CUP remains poor, even if treated~     with conventional chemotherapy. Through ongoing research at medical centers around the world,~     doctors are trying to improve on the presently available chemotherapy regimens. The purpose~     of the investigators' study is similar: it is trying to determine whether a combination of~     three chemotherapy drugs - carboplatin, gemcitabine, and capecitabine - will improve the~     treatment of patients with metastatic CUP. The reason the investigators are interested in the~     above combination of chemotherapy agents is that each one of them is already used in patients~     with a variety of specific tumors, such as lung cancer, breast cancer, pancreatic cancer,~     colon cancer, etc.~      This research study will help determine whether the combination of carboplatin, gemcitabine~     and capecitabine can be used and is effective in patients with carcinoma of unknown primary~     site.~   "
259882|NCT00148122|"~     The purpose of this study is to determine the effectiveness and side effects of a new~     combination and schedule of chemotherapy drugs in the treatment of head and neck cancer.~     Patients with advanced or recurrent head and neck cancer, which is untreatable by surgery or~     radiation therapy are eligible for this study. Standard treatment for advanced or recurrent~     head and neck cancer involves the use of chemotherapy.~   "
259883|NCT00148109|"~     The purpose of this study is to explore how this cancer is affected by a new medication,~     cetuximab. Cetuximab is directed towards a protein called EGFR (epidermal growth factor~     receptor), that is found in some types of cancer. Studies have shown that this drug can be~     beneficial in patients with colon cancer and has been approved by the US Food and Drug~     Administration (FDA) for this purpose. The researchers are conducting a study to see if it is~     beneficial in patients with sarcoma.~   "
259884|NCT00148096|"~     Asthma has become increasingly common in the UK, demanding our consideration of the cause.~     Many patients with asthma are allergic to house dust mites, which thrive in modern housing.~     Improving ventilation in the home has been shown to reduce dust mite levels, by reducing~     humidity levels. It is hoped that, by removing the dust mites from homes, asthma may improve.~     In this study, 140 volunteers will have their carpets steam-cleaned and new allergy bedding~     provided, before a team of architects installs a ventilation system in the loft. Half of the~     units will be switched on at the beginning of the study. The other half will be switched on~     in 12 months time, but only the architects know which units are active. The medical team will~     compare the asthma, and measures of inflammation in the airways, over that year.~      It is due for completion in April 2007.~   "
259885|NCT00148083|"~     The specific aim of this study is to determine whether the new, long-acting, form of~     risperidone, Risperdal Consta, improves the ability of schizophrenia patients to benefit from~     skills training. The hypothesis guiding this study is that Risperdal Consta, by improving~     verbal memory, will improve the ability to benefit from skills training interventions among~     schizophrenia patients. The primary objective of this study is to compare patients on~     Risperdal Consta to patients on other atypical antipsychotic medications in terms of their~     ability to benefit from skills training interventions. A secondary objective of this study is~     to determine whether patients taking Risperdal Consta improve in other areas of cognitive~     functioning and social functioning.~   "
259886|NCT00148070|"~     This is a research study which aims to improve the way that doctors determine the dose of~     chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height~     and weight. However, some patients metabolize chemotherapy faster or slower than the average~     person because of a different level of drug metabolizing enzyme in the liver. Therefore, some~     patients are either given too small or too large a dose of chemotherapy because the amount of~     enzyme is not taken into account. This research study will examine the use of a simple test,~     call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can~     metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored~     to the amount of enzyme which is available to metabolize the drug for each patient.~   "
259891|NCT00148005|"~     Investigation of the prevalence etiology and therapy of micturition disorders of children~     with a mental and/or motoric disability~   "
259896|NCT00147940|"~     The purpose of our study is to correlate nasal volume and cross-sectional area with nasalance~     scores. We will measure nasal volume and cross-sectional area with acoustic rhinometry.~     Nasalance scores will be determined by Nasometry.~      Acoustic rhinometry is a means to study the volume and cross-sectional areas of the nasal~     cavity in a non-invasive, rapid, convenient and reliable manner. Acoustic rhinometry has the~     unique advantage of being completely non-invasive, and thus is able to measure nasal patency~     without the confounding effects of probes or invasive monitoring.~      Nasometry is a technique to measure the oral and nasal components of nasalance. Nasalance is~     the objective measure of the nasal component of speech that is determined by the ratio of~     sound pressure emitted from the nasal and oral cavities during speech. Nasality is the term~     used to characterize the nasal component of speech, and is a subjective measure.~      Eleven healthy subjects underwent acoustic rhinometry pre and post decongestion using~     oxymetazoline 0.05% nasal spray. Nasalance scores were based on the readings of three~     passages: rainbow, zoo, and nasal.~   "
259897|NCT00147927|"~     The purpose of this research is to evaluate the efficacy of a multi-component email health~     promotion program on employee adoption of health promoting behaviors and secondarily on~     health status, work productivity and health care costs.~   "
259898|NCT00147914|"~     This study is a comparison between two commonly used antibiotics (Cefdinir vs.~     Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life.~     The hypothesis is that the two treatments would be at the least equivalent based on clinical~     outcome measures of improvement in quality of life.~   "
259899|NCT00147901|"~     This study aims to assess the short term efficacy of a combination immunochemotherapy in~     patients with relapsed B-cell chronic lymphatic leukemia.~   "
259900|NCT00147888|"~     To study nasal physiologic responses to changes in posture, temperatures, humidity and nasal~     patency with acoustic rhinometry.~   "
259901|NCT00147875|"~     The objectives of this study are to assess the feasibility and efficacy of a combination~     chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.~   "
259902|NCT00147862|"~     To Study whether infusion of Tranexamic Acid (a synthetic antifibrinolytic agent) reduces~     blood loss during head and neck surgery.~   "
259903|NCT00147849|"~     The purpose of this study is to identify, from a societal perspective, the costs and~     associated benefits of three strategies for disseminating and implementing a practice~     guideline that addresses the management of croup.~   "
259904|NCT00147836|"~     The purpose of this study is to investigate and evaluate the effects of different~     interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections,~     3.anti-hyperglycemic agents) on glycemic control, B-cell function and the remission rate in~     newly-diagnosed type 2 diabetic patients.~   "
259905|NCT00147823|"~     This is a prospective randomized study comparing Vitoss alone versus Vitoss with bone marrow~     aspirate in benign bone lesions.~   "
259906|NCT00147810|"~     1. To determine if there are gender differences in asthma prevalence, severity, treatment,~          and health care utilization within patient populations in Kaiser Permanente Northwest~          and Colorado Regions.~        2. To test the ability of an automated telephone outreach intervention to reduce health~          care utilization for acute asthma exacerbations and improve quality of life. The~          intervention used speech recognition technology to gather information about current~          asthma control, patterns of medication use, and recent acute health care utilization for~          asthma. This information allowed the intervention to provide tailored educational~          feedback and to flag patients deemed to be at high risk for future exacerbations so that~          they could be followed up by the health care system.~   "
259907|NCT00147797|"~     The advent of new antiretroviral agents, in particular Highly Active Antiretroviral Therapy~     (HAART), spectacularly reduced HIV-associated morbidity and mortality. However, new~     complications have appeared in HIV-infected patients treated by with HAART such as~     dyslipidemia, insulin resistance, diabetes mellitus, and related cardiovascular complications~     including acute coronary syndromes, peripheral vascular disease, and stroke have been~     reported.~      A linear association has been proved between increased intima-media thickness of the common~     carotid artery (CCA-IMT), aortic stiffness (pulse wave velocity [aPWV]) and incidence of~     cardiovascular events suggesting that IMT and aPWV could be considered as an early marker of~     atherosclerosis. The progression of IMT has been shown to be predictive of cardiovascular~     events. Case control and longitudinal studies but not all have suggested an increase CCA-IMT~     in HIV-infected patients under HAART compared with non-HIV infected patients with different~     progression.~      The aim of this study was to examine the effects of pravastatin on CCA-IMT and aortic~     stiffness in dyslipidemic HIV-infected patients receiving HAART by using a high-resolution~     echotracking system.~      Patients in the pravastatin group were consecutively recruited in four department of~     infectious diseases if they fulfilled the following criteria : (1) HIV-infected treated with~     HAART for > 12 months 2) with dyslipidemia, defined as fasting serum LDL cholesterol > 160~     mg/dL before initiation of pravastatin, (3) treated with pravastatin > 12 months and one more~     coronary risk factor. The patients in the control group were selected consecutively in the~     same departments among 1) HIV-infected patients treated with HAART > 12 months 2) fasting~     serum LDL cholesterol > 160 mg/dL 3) without lipid-lowering drugs and one more coronary risk~     factor. Cases and control patients were matched for age, gender and tobacco consumption.~      Using data from Mercie et al., inclusion of 42 patients in pravastatin and control groups was~     the minimum sample size needed for detection of a 6.5% difference in CCA-IMT, in a two-sided~     test (a = 0.05, b = 0.20).~      The protocol of the study, sponsored by the French Society of Cardiology was approved by the~     Committee for the Protection of Human Subjects in Biomedical Research of Pitié-Salpétrière~     University hospital in Paris. Written informed consent to participate in the study was~     obtained from each patient.~   "
259908|NCT00147784|"~     -  To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able~          to accomplish 14 weeks treatment with Peginterferon alfa-2a (PEG-INF) and ribavirin to~          the same extent than non-opioid dependents.~        -  To determine the efficacy of this anti-HCV treatment~   "
259909|NCT00147771|"~     Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to~     be beneficial in decreasing the thickness of the morphea plaques , while improving their~     appearance. There are no studies to date proving its safety and efficacy in children with~     this disease. We propose to conduct a pilot study to assess to potential efficacy and~     relative safety of Imiquimod in children with plaque morphea.~   "
259910|NCT00147758|"~     The purpose of the study is to see how safe and effective and tolerable the use of~     colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in~     combination with other anti-diabetic drugs.~   "
259911|NCT00147745|"~     This study is designed to assess the potential mechanism of action by which WelChol®~     (colesevelam) may improve blood glucose control in patients with type 2 diabetes~   "
259990|NCT00146640|"~     The objective of this study is to investigate if low doses of prednisone MR formulation,~     given at night and, with active drug release at 2 am, are more effective in controlling joint~     stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone~     given in the morning.~   "
259912|NCT00147732|"~     TITLE:~      A multicentre, randomised, phase III clinical trial comparing accelerated radiotherapy with~     accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in clinical stage T2-4~     laryngeal carcinoma.~      PRIMARY OBJECTIVE:~      Does the addition of carbogen and nicotinamide to a schedule of accelerated radiotherapy in~     patients with clinical stage T2-4 laryngeal carcinoma improve local primary tumour control?~     Definitive analysis will be performed on local control rates at two years after completion of~     radiotherapy.~      SECONDARY OBJECTIVES:~      Does the addition of carbogen and nicotinamide~        -  increase the larynx preservation rate?~        -  increase the regional control rate?~        -  increase the toxicity of accelerated radiotherapy?~        -  improve the overall quality of life?~        -  improve the disease-free survival?~        -  improve the overall survival?~      STUDY DESIGN:~      An open-label, randomised clinical trial assigning patients in a 1:1 ratio to one of the~     following treatment arms:~        -  accelerated radiotherapy~        -  accelerated radiotherapy plus carbogen and nicotinamide~      PATIENT CHARACTERISTICS AND NUMBER:~      344 patients with clinical T2-4 laryngeal carcinoma~      MEASUREMENTS:~        -  time to local failure~        -  time to regional failure~        -  survival with functional larynx~        -  overall and disease-free survival~        -  frequency and severity of complications related to radiotherapy and carbogen and~          nicotinamide~        -  quality of life assessment~   "
259913|NCT00147719|"~     The purpose of the study is to see how safe and effective and tolerable the use of~     colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in~     combination with other anti-diabetic drugs.~   "
259914|NCT00147706|"~     The purpose of this study is to determine if patients with congestive heart failure, diabetes~     or secondary cardiovascular diseases, who access HealthMedia's online tailored behavior~     change programs on the electronic health record patient portal have better clinical and~     behavioral change outcomes.~   "
259915|NCT00147693|"~     The objective is to ascertain the potential efficiency of a systematic care programme for~     caregivers of dementia patients. The research questions are:~        -  What are the costs and benefits of the Systematic Care Programme - Dementia~          (SCP-Dementia), as compared with usual care?~        -  What are the effects on the quality of life of patients and informal caregivers (spouse,~          relative), as compared with usual care?~   "
259916|NCT00147680|"~     This study will be an open, non-randomised, clinical phase 2 trial, which will involve 30~     women diagnosed with uterine papillary serous cancer. The researchers will investigate the~     effect of four cycles of paclitaxel/carboplatin, followed by whole pelvic external beam~     radiotherapy to a standard pelvis field (50.4 Gy) with or without a para-aortic boost with~     respect to the safety and efficacy of treatment, and patterns of recurrence.~   "
259917|NCT00147667|"~     The purpose of this study is to determine whether long term treatment with oral erythromycin~     is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD)~     by reducing the number of exacerbations and the degree of airway inflammation.~   "
259918|NCT00147654|"~     The primary objective of the trial is to evaluate the effect of tolterodine ER plus~     tamsulosin versus placebo on patient perception of overall treatment benefit in men who have~     frequency and urgency, with or without urinary urge incontinence (UUI), with or without~     bladder outlet obstruction (BOO).~   "
259919|NCT00147628|"~     To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction~     in men with ED as well as to validate the new Sexual Experience Questionnaire which~     incorporates functional and emotional elements of a man's sexual experience into one~     comprehensive questionnaire.~   "
259920|NCT00147615|"~     To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16~     years with high blood pressure. The study will last at least 1 year and about 140 patients~     will participate.~   "
259921|NCT00147602|"~     To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a~     previous stroke or transient ischemic attack.~   "
259922|NCT00147589|"~     To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children~     aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and~     about 320 patients will participate.~   "
259923|NCT00147576|"~     Test the hypothesis that increasing doses of CP-866,087 will decrease the total number of~     drinks consumed during a 2 hour acute alcohol consumption assessment and to determine the~     safety and tolerability of multiple doses of CP-866,087 in alcohol dependent subjects~     compared to placebo.~   "
259924|NCT00147563|"~     To investigate the impact of antihypertensive therapy with the selective mineralocorticoid~     receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect~     of equivalent blood pressure control achieved with a b-blocker, atenolol.~   "
259925|NCT00147550|"~     MEK is a critical member of the MAPK pathway involved in growth and survival of cancer cells.~     PD-325901 is a new drug designed to block this pathway and kill cancer cells. The purpose of~     this study is to study the effectiveness of PD-325901 in patients with colon cancer, breast~     cancer, and melanoma. PD-325901 will be given by mouth as a pill twice a day, CT scans will~     be done and biopsies will be taken of a tumor before and once during treatment to measure the~     effects of the drug. Blood samples will be taken to measure the amount of drug in the blood.~   "
259926|NCT00147537|"~     Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of~     recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin~     Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when~     administered with paclitaxel, carboplatin and erlotinib.~      Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the~     treatment of advanced non-small cell lung cancer~   "
259938|NCT00147368|"~     Acute falciparum malaria is associated with low plasma arginine and impaired nitric oxide~     (NO) production. Both are associated with poor outcome. This study will examine the safety~     and effect of escalating doses of arginine in falciparum malaria. It will determine whether~     arginine can increase NO production and have an effect on NO-dependent physiological~     measurements. The hypothesis is that arginine: will be safe in falciparum malaria; will~     return plasma arginine concentration to normal/supranormal levels; will increase systemic and~     exhaled NO; reduces oxidant stress; and improves a number of NO-dependent physiological~     measures of relevance to malaria.~   "
259927|NCT00147524|"~     ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an~     effective and well-tolerated ACE-I for the treatment of patients with hypertension and~     congestive heart failure. Quinapril produces favourable haemodynamic changes and improves~     ventricular and endothelial function in patients with various cardiovascular disorders. These~     effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE.~      Quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved FMD~     or reduced vasoconstrictive/increased vasodilative response to Ach) in patients with CAD and~     hypertension over 2 to 6 months of therapy; improved endothelial function was also observed~     in patients with CHF receiving a single infusion of quinaprilat. In general, quinapril showed~     neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) There~     are no data available considering effects of quinapril on endothelial dysfunction in post-~     menopausal woman with mild to moderate hypertension and with pathological endothelial~     function.~   "
259928|NCT00147511|"~     To assess the onset of action of linezolid~   "
259929|NCT00147498|"~     The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550~     monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6~     weeks for the treatment of the signs and symptoms of subjects with active rheumatoid~     arthritis (RA).~   "
259930|NCT00147485|"~     AG-024322 may work in cancer by stopping cancer cells from multiplying. AG-024322 is and~     intravenous drug from a new class of drugs call cyclin-dependent kinase (CDK inhibitors).~     This research study is the first time that AG-024322 will be given to people.~   "
259931|NCT00147472|"~     The purpose of this trial is to determine the ability of positron emission tomography (PET)~     to detect residual cancer in neck lymph nodes of patients following curative treatment with~     radiation therapy for squamous cell cancer arising in the head and neck.~      Patients with head and neck cancer (HNC) undergo treatment of curative intent; patients who~     are node positive (N2 N3 stages) undergo standard management which includes post-radiation~     planned neck dissection but two thirds of patients end up not having evidence of residual~     disease in neck dissection specimens; these patients could have avoided surgery. However,~     currently used standard tests, like computed tomography (CT) and/or magnetic resonance~     imaging (MRI) cannot reliably predict who is post-radiation disease free.~   "
259932|NCT00147459|"~     Aim/Background: This study aims to investigate the necessity and efficacy of a hepatitis B~     virus (HBV) vaccine booster in children after liver transplantation. A universal mass~     vaccination program of HBV was launched for 20 years in Taiwan. The coverage rate is high and~     the effect is great. The carrier rate of the population under vaccine coverage decreased from~     10-15% to < 1%. In Taiwan, most children who receive organ transplantation were vaccinated~     with HBV vaccine in infancy and well before the transplantation procedure. This vaccination~     background information on Taiwanese children is quite unique and not similar to the other~     countries in the world. The antibody generated by the vaccine usually wanes after a certain~     period even in normal subjects, let alone in subjects who receive organ transplantation and~     immunosuppressive agents after transplantation. At present, Taiwan is still an HBV~     hyperendemic area and the risk of exposure to HBV cannot be overlooked. Should children be~     given a booster dose of HBV vaccine after transplantation? And how about the immunogenicity~     of this booster dose in these immunocompromised hosts? If these children cannot obtain an~     adequate antibody titer, will the risk of HBV infection increase? This study is designed to~     answer these questions. As a pediatric hepatologist, the author's routine work is to take~     care of children who underwent liver transplantation. To take advantage of this, the~     investigators decided to study the efficacy and necessity of HBV booster vaccine in these~     patients. However, the results of this study should be able to be applied to any kind of~     solid organ transplanted patients.~      Method: The anti-hepatitis B surface antigen (HBs) titer will be checked in patients who~     received liver transplantation > 1 year ago. If the titer is < 10 IU/L, a booster dose will~     be administered. The humoral (anti-HBs) and cellular immunity (by ELISPOT to assay T and B~     cell specific proliferation) and cytokine assay will be done in these patients before and~     after the booster dose. A three-year follow-up will be performed to monitor the HBV infection~     in these patients.~      Expected Results: The investigators expect for those who survive one year more after liver~     transplantation to yield a relatively good response to HBV booster under adequate~     immunosuppression.~   "
259933|NCT00147446|"~     There is a growing body of literature showing that stressful life events can increase the~     risk of developing exacerbations and new brain lesions among people with multiple sclerosis.~     The purpose of this study is to examine the hypothesis that stress management programs can~     reduce the occurrence of new brain lesions and exacerbations. We will also examine potential~     immune and neuroendocrine pathways.~   "
259934|NCT00147433|"~     This study is designed to test the hypothesis that the level of the thyroid hormone thyroxine~     (specifically, free thyroxine, FT4) circulating in the blood of pregnant women is the key~     thyroid-related factor to influence early fetal brain development. The investigators will~     recruit 5000 pregnant women with clinically normal thyroid function (normal thyroid~     stimulating hormone levels) in the second trimester. After the baby has been born, the~     investigators will measure FT4 in the second trimester maternal blood sample to identify 100~     cases (very low FT4 levels) and 100 matched controls (normal FT4 levels). The children of~     cases and controls will undergo neurodevelopmental testing at 2 years of age to determine~     whether IQ differs according to maternal FT4 levels during pregnancy. The potential impact of~     the study is that if such an effect is found, it might be possible to avoid these adverse~     developmental consequences in children by designing and testing strategies to identify and~     treat high risk women.~   "
259935|NCT00147420|"~     Previous research has confirmed that hemorrhage is among the most commonly encountered~     pregnancy complications in the Tibet Autonomous Region (TAR). This trial will test the~     effectiveness of a traditional Tibetan drug (Zhi Byed 11) vs. misoprostol to prevent~     postpartum hemorrhage (PPH) among women delivering vaginally in three hospitals in Lhasa,~     TAR.~   "
259936|NCT00147394|"~     The purpose of this research is to study the pharmacokinetics of risperidone in a group of~     pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how~     much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following~     the patient's usual daily dose. The study is designed to look at how fast children absorb,~     breakdown, and eliminate risperidone.~   "
259937|NCT00147381|"~     The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is~     more effective in the prevention of renal graft rejection (considering an acute rejection~     rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).~   "
259939|NCT00147355|"~     This substudy is an open-label, randomised study comparing the uptake of recombinant~     interleukin-2 (rIL-2) in HIV-1 infected individuals receiving different combinations of~     antiemetics and analgesic agents during rIL-2 dosing in ESPRIT. The design is a factorial one~     with 4 arms. All patients will receive regular ibuprofen and paracetamol from days 1-6 of the~     rIL-2 dosing cycle; in addition, patients will be randomised to receive one of two antiemetic~     combinations, i.e. ondansetron or metoclopramide with or without low dose codeine phosphate~     as an additional analgesic agent.~   "
259940|NCT00147342|"~     Most children with type 1 diabetes have a drop in the blood sugar during exercise. This drop~     in the blood sugar can result in hypoglycemia (low blood sugar). In children using an insulin~     pump, there is an opportunity to reduce the basal insulin rate during exercise. This study is~     being conducted to determine if decreasing the insulin that is received during exercise will~     reduce the risk of hypoglycemia. We hope to learn more about how the body responds to~     hypoglycemia and to hyperglycemia (high blood sugar) when it occurs.~      As part of the study, children will have a visit on two different days. During each visit,~     children will exercise on a treadmill for about 60 minutes. During one of the visits, the~     children's basal rate will be continued during the exercise. During one visit, the basal~     insulin will be stopped. The blood sugar will be checked frequently during the exercise.~   "
259941|NCT00147329|"~     Merrimack is conducting a research study to see if an experimental drug, called MM-093, is~     safe and effective in the treatment of psoriasis. MM-093 is a genetically engineered version~     of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have very~     small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both the~     mother and the fetus are much higher than normal. It has been observed that some women with~     psoriasis and other autoimmune diseases such as rheumatoid arthritis have fewer symptoms~     during pregnancy, particularly during the third trimester. At this time, the levels of AFP in~     the blood of the mother and fetus are the highest. This observation led Merrimack to begin~     examining MM-093 as a potential treatment for psoriasis. This study is designed to further~     test the safety and effectiveness of MM-093 in patients with psoriasis.~   "
259942|NCT00147316|"~     Based on previous studies comparing Duteplase[a recombinant tissue plasminogen activator~     (rt-PA) very similar to alteplase] doses, we performed a clinical trial with 0.6mg/kg, which~     is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy~     and safety of alteplase for the Japanese.~   "
259943|NCT00147303|"~     Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in~     platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral~     arterial disease.~      The present double-blind controlled clinical pharmacology study was performed on 45 patients~     with cerebral infarction, who were given 75, 150, or 300 mg three times daily of sarpogrelate~     for 7 days in order to evaluate the dose-response relationship in terms of the precisely~     measured inhibition of platelet aggregation.~   "
259944|NCT00147290|"~     To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in~     patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I~     or IIA indication for ICD implantation.~      The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in~     a prospective, controlled and randomized study.~   "
259945|NCT00147277|"~     The purpose of this study is to estimate and quantify the difference in efficacy of two~     sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an~     episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via~     ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD~     implantation, and thus to promote the painless therapy aspect of ICD treatment and improve~     quality of life outcomes for patients.~   "
259946|NCT00147264|"~     The purpose of this study is to determine whether telmisartan and/or a low-glycemic index~     diet are effective in reducing intra-myocellular lipid (muscle fat) content.~   "
259947|NCT00147251|"~     Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad~     cholesterol) and blood pressure in people with diabetes will slow the progression of~     atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular~     events such as heart attacks and strokes. This study is a randomized 3-year trial. The~     primary endpoint will be a combination of various measures of the carotid artery, (which is~     an easy, non-invasive way to detect cardiovascular disease) and events such as heart attacks~     and strokes. The study will also look at secondary endpoints such as how well the heart~     pumps, fat,protein and inflammatory markers in the blood,and kidney function. The study~     enrolled 549 American Indian men and women with diabetes, > 40 years of age and is being~     conducted in four field centers involving Indian Health Service/Tribal primary care~     facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota;~     and Lawton, Oklahoma, with input from American Indian physicians and community members.~   "
259948|NCT00147238|"~     The goal of this clinical research study is to evaluate how well ferumoxtran-10, a new~     Magnetic Resonance Imaging (MRI) contrast agent, can detect cancer in the pelvic lymph nodes~     or malignant pelvic lymph nodes.~   "
259949|NCT00147225|"~     The goal of this clinical research study is to find the highest safe dose of AMG 531 that~     will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who~     have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG~     531 (Romiplostim).~      Primary Objectives:~        1. To determine the clinical safety and tolerability of AMG 531 administered following~          chemotherapy in patients with advanced malignancy~        2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients~          receiving chemotherapy known to cause severe thrombocytopenia~        3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and~          platelet recovery following chemotherapy~      Secondary Objective:~      1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route~     post-chemotherapy~   "
259950|NCT00147212|"~     The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743)~     has on men with advanced prostate carcinoma.~   "
259951|NCT00147199|"~     This is a double-blind placebo-controlled clinical investigation into the efficacy and~     tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.~     The primary outcome is the change in 6-minute walk distance from baseline to week 12.~   "
259987|NCT00146679|"~     The overall purpose of this study is to test the effects of a nurse managed psychoeducational~     intervention, consisting of symptom management training (SMT) and cognitive-behavioral~     intervention (CBI), during the first year after ICD implantation using a 3 group randomized~     clinical trial.~   "
259988|NCT00146666|"~     The purpose of this study is to determine whether 12 weeks of daily home use of the FM220 in~     the most affected leg of patients with PAD and claudication, will improve peak walking time~     (PWT) at three months as compared with a non-treated control group.~   "
259952|NCT00147186|"~     The use of Hylan G-F 20 as a treatment of osteoarthritis (OA) of the knee has become popular~     in recent years. Typical treatment of OA of the knee includes NSAIDs and physical therapy~     protocols to strengthen local muscle groups and decrease pain. When these conservative~     treatment modalities have been exhausted, the next step is arthroplasty of the knee. Hylan~     G-F 20 treatments provide physicians with an intermediate mode of treatment prior to surgery.~     Hylan G-F 20 is a cross-linked, high molecular weight derivative of hyaluronan which can be~     found within the synovial capsule of the knee. This form of viscosupplementation is intended~     to reduce the pain suffered by those with OA by increasing the fluid levels within the~     synovial space, providing a cushion between the bony surfaces within the knee joint. Current~     studies have only looked at self-reported pain relief or Outcomes Inventories. This study~     aims to determine the ability of Hylan G-F 20 treatment to improve the parameters of gait of~     individuals who suffer from OA.~   "
259953|NCT00147160|"~     The purpose of this study is to determine whether the combination of Temozolomide and~     Cisplatinum is effective in the treatment of malignant glial tumours of children and~     adolescents~   "
259954|NCT00147147|"~     To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or~     greater lymph node dissection in T3-4 gastric cancer patients.~   "
259955|NCT00147134|"~     The purpose of this study is to evaluate oncological outcome of patients for T3 and T4~     colorectal cancer undergoing laparoscopic versus open surgery.~   "
259956|NCT00147121|"~     To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma~   "
259957|NCT00147108|"~     The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS~     treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a~     fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional~     area of > 50% on palpation, and >65% in lesion volume as measured by MRI (both calculations~     assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size,~     along with the softening of the treated volume will result in satisfactory clinical results~     in greater than 50 % of the patients.~   "
259958|NCT00147095|"~     The aim of this study is to investigate the mechanisms whereby lung function is decreased in~     COPD. The hypothesis is that in diseases such as COPD, inflammatory cells including~     neutrophils, macrophages and lymphocytes migrate to the lung and release either more or~     different types of inflammatory mediators and/or destructive enzymes compared to subjects~     without COPD. We aim to investigate these separate cell types in the blood of subjects with~     COPD and identify which genes are more highly expressed when compared to cells obtained from~     patients without COPD. We will also investigate the lung macrophages from these subjects to~     identify whether the same or different genes are expressed in these cells. We will isolate~     different leukocyte populations from the blood and extract ribonucleic acid (RNA) from these~     samples. The type and quantity of RNA in these samples is a reflection of the specific genes~     expressed in these cells. This RNA will be sent to Gene Logic and this company will test~     these samples to identify which genes have been expressed. Similar experiments will be~     performed using macrophages obtained following bronchoalveolar lavage of these subjects. We~     would aim to examine the responses of leukocytes from three groups of subjects, namely (i)~     non-smoking controls (ii) smokers without clinical or histological signs of COPD and (iii)~     smokers with COPD. The isolated leukocytes will either be immediately solubilized in~     solutions to purify RNA or we will then use these isolated cells in vitro and following~     stimulation investigate whether different genes are expressed or at a differential rate in~     the disease state. The objective is to identify which genes are specifically expressed in~     patients with COPD with a view to identify novel targets for drug therapy. We will examine~     both leukocytes derived from peripheral blood and macrophages obtained from bronchoalveolar~     lavage with the aim to determine whether differences attributable to disease can be~     identified in both circulating cells and those at the site of disease. This is a preliminary~     study to determine the profile of inflammatory mediator expression from leukocytes and as~     such power calculations to determine the number of subjects is not appropriate.~   "
259959|NCT00147082|"~     The aim of this study is to investigate the mechanisms whereby leukocytes are recruited to~     the lung in chronic obstructive pulmonary disease (COPD) and cause tissue destruction. The~     hypothesis is that in COPD more leukocytes enter the lung and it is these cells that are~     responsible for the degradation of lung tissue. We, the researchers at Imperial College~     London, will isolate leukocytes from the blood of patients with COPD, healthy smokers and~     normal subjects and measure the movement of the leukocytes to chemoattractants. We will~     examine further, which cell surface receptors are responsible for this trafficking of cells.~     Furthermore, the differentiation of these cells in vitro will be compared with cells from~     healthy smokers and normal subjects. Specifically, the expression of enzymes that are~     responsible for tissue destruction and the cell surface receptors on these cells will be~     investigated. The objective is to identify the mechanisms whereby leukocytes from COPD~     patients behave differently to cells from healthy smokers and normal subjects with a view to~     identify novel targets for drug therapy.~   "
259960|NCT00147069|"~     The aim of this study is to examine the inflammatory mechanisms involved in the pathogenesis~     of inflammatory lung disease, in particular to compare the inflammatory profile seen in~     asthma and COPD. Evidence for inflammation in asthma and COPD is based on the finding of~     increased numbers of macrophages and neutrophils in the lungs and respiratory secretions of~     these patients. The inflammatory cells produce proteases, as well as, reactive oxidant~     species resulting in a protease/anti-protease imbalance which favours lung destruction. The~     aim is to examine the inflammatory mediators released by inflammatory cells (such as,~     macrophages and lymphocytes) in order to determine whether there are differences between~     non-smoking subjects, smoking subjects and patients with asthma or COPD. Monocytes are~     precursors of alveolar macrophages, and both monocytes and neutrophils are recruited to the~     lung from the blood via the action of specific chemoattractants. We have evidence that in~     inflammation there are higher levels of these chemoattractants. Therefore these cells might~     also demonstrate the same changes seen in alveolar macrophages from these patients.~      We also aim to assess the role of the macrophage precursor (monocyte) and neutrophils in the~     blood. We will also assess lymphocyte/monocyte interaction. We will do this as the lymphocyte~     may be involved in the initial recruitment of inflammatory cells. We will also assess the~     role of cytokines involved with monocyte/macrophage/neutrophil migration in induced sputum as~     well as the role of induced sputum in the migration of monocytes and neutrophils into the~     lung. Our aim is to link the initial changes in blood to the changes causing disease in the~     lungs. We aim to examine cellular responses in four groups of subjects, namely (i)~     non-smoking controls, (ii) smokers without clinical evidence of COPD or asthma, (iii) smokers~     with COPD (iv) asthmatic patients.~   "
259961|NCT00147056|"~     The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal~     ablation of brain tumors performed through intact human skull using the ExAblate transcranial~     system. We will collect data to establish the basic safety of this type of treatment as the~     basis for later studies that will evaluate its clinical efficacy.~   "
259962|NCT00147043|"~     In order to determine the clinical application potential of adult stem cells we propose to~     investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or~     portal vein of five patients with chronic liver insufficiency and to identify any clinical~     benefit if such occurs.~      Objectives:~        1. To assess safety and treatment related toxicities~        2. To determine clinical benefit or deterioration by monitoring changes in liver function~   "
259963|NCT00147030|"~     Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial~     encephalopathy reduces death and severe neurodevelopmental disability.~      This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that~     improves survival, without severe neurological or neurodevelopmental impairments at 18~     months, of term infants suffering perinatal asphyxial encephalopathy.~   "
259964|NCT00147017|"~     The aim of this study is to investigate the mechanisms whereby specific white cells called~     macrophages found in the lung release inflammatory mediators or chemicals together with~     enzymes that destroy the surrounding lung tissue. The hypothesis is that in diseases such as~     chronic obstructive pulmonary disease (COPD), lung macrophages release either more or~     different types of inflammatory mediators and/or destructive enzymes compared to subjects~     without COPD. We will isolate macrophages from small pieces of lung parenchyma. These samples~     are derived from lobes resected for carcinoma of the lung. We would aim to examine the~     responses of tissue derived macrophages in three groups of subjects, namely (i) non-smoking~     controls (lung carcinoma as secondary metastasis), (ii) smokers without clinical or~     histological signs of COPD and (iii) smokers with COPD. The resected lung tissue will be cut~     into small pieces and washed in order to release the macrophages from the tissue. The~     macrophages will then be isolated from other cell types in the washings. We will then use~     these isolated cells in vitro to examine the cell surface receptors in order to compare these~     macrophage cells with macrophages reported from bronchoalveolar lavage and monocyte derived~     macrophage models. We will then examine inflammatory mediator synthesis and release following~     stimulation of these cells. We will also examine the regulation and release of enzymes known~     to damage lung tissue. Using these two models we will then examine the signal transduction~     pathways that lead to this activation of the macrophages and investigate the effects of novel~     therapeutic agents to inhibit inflammatory mediator and/or enzyme synthesis and release. The~     objective is to identify the mechanisms whereby macrophages respond to pro-inflammatory~     conditions seen in COPD with a view to identify novel targets for drug therapy.~   "
259965|NCT00147004|"~     The purpose of the study is to determine whether steroids decrease 28-day mortality in~     patients with septic shock.~   "
259966|NCT00146978|"~     Graft versus host disease (GVHD) is a major complication of allogeneic bone marrow~     transplantation (BMT), resulting in death in the majority of steroid resistant patients. The~     study was designed to assess the efficacy of regional intra-arterial treatment in patients~     with resistant hepatic and/or gastro-intestinal GVHD.~   "
259967|NCT00146952|"~     The investigators propose to explore the hypothesis that vibrotactile channels for indicating~     spatial orientation can be exploited as a sensory prosthesis. The specific research~     applications will be used for guiding visual orientation, to provide alternative feedback to~     vision and vestibular signals for controlling balance, and for directional and lateralisation~     cueing in patients with neglect syndromes. The programme will study whether vibrotactile~     feedback improves performance and also if it speeds rehabilitation when used as an adjunct to~     conventional therapy.~   "
259968|NCT00146926|"~     Propofol is a popular intravenous drug to induce anesthesia but it causes local pain with an~     incidence between 40 and 90%. Three different strategies to prevent propofol induced pain~     will be studied compared with placebo. Pain will be scored with a four-point scale.~   "
259969|NCT00146913|"~     Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses~     (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it~     has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on~     chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase~     the cytogenetic response of patients.~   "
259970|NCT00146900|"~     To prospectively evaluate the effect of early treatment (cognitive therapy (CT),~     cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of~     post-traumatic stress disorder in recent survivors of traumatic events.~   "
259971|NCT00146887|"~     The purpose of the trial is to investigate the accuracy of coronary CT compared to the~     conventional gold standard cardiac catheterization.~   "
259972|NCT00146874|"~     This registry will provide detailed patient demographics and characteristics at the time of~     enrollment and will also provide data regarding predictors of clinical outcomes such as heart~     failure decompensation, heart failure hospitalization, NYHA class, and quality of life.~   "
259973|NCT00146861|"~     This study will compare how two different sensors inside the pacemaker may affect patients'~     quality of life.~   "
259974|NCT00146848|"~     This study will look at different pacing modes (how a device is programmed to pace one's~     heart), and how these modes may assist in one's daily activities and how one is feeling.~   "
259975|NCT00146835|"~     Pre-licensure studies of GSK Biologicals' PEDIARIX vaccine have shown it to be generally safe~     and unlikely to result in vaccine-associated serious adverse events. This post-licensure~     study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort.~   "
259976|NCT00146822|"~     The REFLEx Study will evaluate if ENDOTAK RELIANCE G defibrillation leads with GORE~     ePTFE-covered coils are as good as or better than other comparative commercially available~     defibrillation leads with respect to electrical performance and termination efficacy in~     spontaneous tachyarrhythmic episodes.~   "
259977|NCT00146809|"~     Study Hypothesis:~      - Does a treatment with Minocycline of 2 x daily 2 x 50 mg effect the progression of clinical~     symptoms and diagnosis in patients with MSA?~      Background and Rationale:~        -  The Parkinson-Syndrome which is characterised by the clinical triad akinesis, rigor and~          passive tremor, is caused by Parkinson's disease (PD) in about 70 % of the cases (Oertel~          et al., 2003). However, beside the Parkinson's disease there are several, to some extent~          rare, so-called atypical Parkinson's syndromes. The two most frequent of these atypical~          Parkinson-Syndromes are the~        -  Multi-System-Atrophy (MSA) and the Progressive Supranuclear Palsy (PSP). Due to the~          often much varying courses and since they are not well known, these diseases are~          frequently diagnosed late or not diagnosed at all. Nevertheless, an early diagnosis is~          substantial for further treatment, since the prognosis and therapy of atypical Parkinson~          Syndromes differ essentially from those of PD. Whereas the neuronal death of cells in PD~          is restricted essentially to the Substantia nigra, a dominant destruction of neurons in~          brain stem, Cerebellum and Striatum additionally happens in cases of MSA and PSP.~        -  Up to now no adequate treatment strategies are at disposal. Initially the giving of~          L-Dopa can lead to an improvement for < 10% of the patients only.~        -  Minocycline is an antibiotic belonging to the group of the Tetracyclines.~        -  Recently, it could be demonstrated that Minocycline has a neuroprotective impact besides~          the anti-inflammatory impact.~   "
259989|NCT00146653|"~     We propose a comparison between between our standard ACT based heparin management protocol~     for children undergoing CPB and a patient-specific heparin concentration-based heparin~     management protocol. We hypothesize that a heparin concentration-based anticoagulation~     management protocol during CPB in children will result in more effective attenuation of~     hemostatic activation as reflected by decreased levels of thrombin formation and, ultimately,~     better preservation of hemostasis postoperatively.~      An additional 20 patients will be enrolled to address the validation of heparin~     concentrations calculated by the Hepcon machine with laboratory-measured heparin~     concentrations. These patients will not be randomized and therefore will not receive an~     intervention.~   "
259978|NCT00146796|"~     There is clear evidence diagnosis of malaria in much of Africa is sub-optimal and this has a~     negative impact on patient care. Many of those treated for malaria do not have it. Rapid~     diagnostic tests (RDTs) are dipsticks which diagnose malaria rapidly and accurately. The main~     objective of this trial is to determine by means of a randomised trial the impact of~     introducing RDTs into a standard outpatient setting in Tanzania has on the appropriate~     prescription of antimalarials. Other objectives are:~        1. To compare at high, moderate and low P.falciparum transmission intensity the sensitivity~          and specificity of malaria diagnosis using hospital slide results and RDTs, using~          research quality slides as the reference.~        2. To estimate the specificity of clinical diagnosis of malaria at high, moderate and low~          transmission intensity of P. falciparum.~        3. To compare the proportion of cases reported as slide-negative who are treated for~          malaria with the proportion of RDT-negative cases treated for malaria.~        4. To evaluate the cost effectiveness of introducing RDTs compared to current diagnostic~          practice in facilities with microscopic diagnosis of malaria at different levels of~          transmission of P.falciparum.~   "
259979|NCT00146783|"~     In areas of stable transmission, pregnant women, especially during the first and second~     pregnancies, have an increased susceptibility to Plasmodium falciparum malaria,~     malaria-related anaemia and an increased risk of having low birthweight babies. Intermittent~     Preventive Treatment in pregnancy(IPTp) with sulphadoxine-pyrimethamine has been shown to be~     effective in reducing the effects of malaria in pregnancy. This has mainly been in areas of~     perennial transmission and there is a need to study this effect in intense seasonal~     transmission settings. The emergence and spread of resistance to SP is likely to undermine~     its useful lifespan and it is important that other antimalarials that are safe and effective~     are identified for use in IPTp. The options are however limited. Amodiaquine has been shown~     to be effective in treatment of clinical cases of malaria, even in areas where chloroquine~     resistance is prevalent, and its combination with SP has been associated with favourable~     results. Both are affordable. However, there is limited data on their use in pregnancy. This~     study aims to assess the efficacy of SP in an area of intense seasonal transmission, and~     evaluate the safety and efficacy of amodiaquine and a combination of~     sulphadoxine-pyrimethamine and amodiaquine as possible alternatives to SP for use as IPTp.~   "
259980|NCT00146770|"~     This study is being conducted to collect additional long-term efficacy and safety data of~     Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled~     in the Phase 3 Double-Blind Study will be enrolled in this study.~   "
259981|NCT00146757|"~     The main objectives of this study are to evaluate the safety and pharmacokinetics (PK) of~     enzyme replacement therapy with recombinant human alpha-L-iduronidase [Aldurazyme®~     (laronidase)] in mucopolysaccharidosis I (MPS I) patients less than 5 years old. Efficacy~     measurements will also be evaluated in this study.~   "
259982|NCT00146744|"~     This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in~     healthy European volunteers who are PPD-positive either via previous vaccination with BCG~     and/or conversion to PPD positivity through exposure to Mycobacterium tuberculosis.~   "
259983|NCT00146731|"~     Pregnant women are vulnerable to malaria, with significant implications both for their health~     and for the pregnancy. Sulfadoxine-pyrimethamine (SP) is currently the first line drug for~     the treatment of malaria in pregnancy in Tanzania and surrounding countries, but resistance~     is emerging rapidly. Alternative drugs must be found, and new drugs and drug combinations are~     being recommended by many for deployment as first line treatment at the point that SP~     resistance forces a policy change. However, there are few data on the safety and efficacy of~     these combinations in pregnant women. This randomised trial aims to assess efficacy and~     safety, including birth outcome, in pregnant women with malaria in the second or third~     trimesters. A total of 900 pregnant women will be randomised either to standard treatment~     (SP) or to one of three potential drugs, or drug combinations recently recommended by a WHO~     expert panel. These will be SP-amodiaquine, chlorproguanil-dapsone (Lapdap), and~     amodiaquine-artesunate. Primary outcome will be treatment failure. Secondary outcomes will~     include 28 day slide clearance, maternal side effects, foetal viability and birth outcome.~   "
259984|NCT00146718|"~     The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ),~     sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their~     baseline characteristics for malaria. In addition, drug resistance will be determined by~     measurement of blood drug levels,and identification of molecular markers of resistance.~   "
259985|NCT00146705|"~     The aim of this study was to investigate the long term outcome of Peginterferon alpha-2b with~     or without the addition of lamivudine in patients with chronic hepatitis B~   "
259986|NCT00146692|"~     Effective control strategies for malaria depend both on preventing disease and on treating~     those who become infected to prevent significant morbidity and mortality. There are many~     barriers to preventing access to prompt and effective treatment, some of which are amenable~     to intervention, others (such as distance to healthcare) less so. This study will concentrate~     on modifiable financial barriers to care.~      With the aim of increasing health service utilization and reducing morbidity and mortality~     among children under five, some governments are currently implementing policies aimed at~     reducing financial barriers to health care. There is at the same time an on-going debate~     concerning the relative importance of cost as a barrier to health care. Though theoretically~     the aim for reducing these barriers should be achieved, its actual impact has not been~     directly assessed or demonstrated by means of an intervention trial.~      This study aims to determine by means of a randomized trial the impact of reducing such~     barriers on morbidity due to severe malaria among children 6 months to five years and on~     outpatient utilization. An existing pre-payment scheme in the study area will be utilized to~     improve financial access for half of 2500 households who have not registered for either year~     I or II. The impact on severe anaemia, mean haemoglobin and anthropometric measurements will~     be assessed. Health service utilisation rates will be measured in both groups by active and~     passive surveillance. Patient perceptions and health-seeking behaviour will be compared. The~     study will contribute to the current debate on the relative importance of cost of care as a~     barrier to health care and the potential for the removal of this barrier as a strategy for~     malaria control, and on methods to optimise this.~   "
260145|NCT00144586|"~     This is an open-label, extension, Phase III study to evaluate the long-term safety and~     efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.~   "
259991|NCT00146627|"~     The purpose of this study is to compare the therapeutic combination of I.V. eflornithine +~     oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and~     clinical safety, in patients suffering from Trypanosoma brucei gambiense (Tbg) human African~     trypanosomiasis (HAT) in the meningoencephalitic phase.~   "
259992|NCT00146614|"~     The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD)~     after non-myeloablative transplantation can be reduced by using a combination of three immune~     suppressive medication; sirolimus, tacrolimus and methotrexate.~   "
259993|NCT00146601|"~     The purpose of this study is to test the effectiveness and safety of fulvestrant in~     premenopausal women with advanced breast cancer.~   "
259994|NCT00146588|"~     The purpose of this study is to find out what effects (good and bad) a combination of~     cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.~   "
259995|NCT00146575|"~     The purpose of this study is to compare the efficacy of paclitaxel- and sirolimus-eluting~     stents to prevent re-blockage of small coronary arteries~   "
259996|NCT00146562|"~     The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in~     supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell~     growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in~     chemotherapy recipients.~   "
259997|NCT00146549|"~     The purpose of this study is to compare two different combinations of chemotherapy with~     trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the~     patients will receive trastuzumab in combination with a taxane form of chemotherapy (either~     paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with~     vinorelbine.~   "
259998|NCT00146536|"~     The goal of this study is to determine how often patients who have atypical lobular~     hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging~     (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at~     surgical removal of the area.~   "
259999|NCT00146523|"~     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called~     cortisol. Under normal conditions, cortisol and other hormones are created by the body in~     response to physical and emotional stress, triggering a healthy stress response. People who~     suffer from psychotic major depression may have unusually high levels of cortisol circulating~     within them or abnormal patterns of cortisol levels, overloading the stress response~     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If~     Corlux can keep the body's cortisol receptors from being overloaded, the stress response~     system may return to normal function, which may result in improvement of symptoms. The~     purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients~     who have been diagnosed with psychotic major depression (PMD).~   "
260000|NCT00146510|"~     The purpose of the study is to determine the efficacy of resting metabolic rate (RMR) using~     BodyGem and BalanceLog in helping overweight and obese individuals manage their weight.~   "
260001|NCT00146497|"~     Pulmonary inflammation plays an important role in the development of chronic lung disease~     (CLD) in preterm infants. This inflammation occurs very early in postnatal life. Any therapy~     that could be beneficial in preventing CLD should be started very early. The investigators'~     previous double-blind study has shown that early (< 12 hours) postnatal use of intravenous~     dexamethasone for 4 weeks significantly suppressed pulmonary inflammation and significantly~     reduced the incidence of CLD. However, the use of dexamethasone was associated with increased~     incidence of infection and sepsis. Their follow-up study also suggested an increase in the~     incidence of psychomotor anomalies. As compared to intravenous administration, endotracheal~     instillation will provide more local anti-inflammatory effects and less systemic side~     effects. Infants will be eligible for the study if their birth weight (BW) is < 1500 gm and~     if they had severe respiratory distress syndrome (RDS) requiring mechanical ventilation~     shortly after birth. After informed consent is obtained, the infant will be randomly assigned~     depending on the condition of the infant. The primary outcome is the change in cytokines~     (interleukin-6, 8, 10 and TNF-α) levels in BAL fluid. Chronic lung disease (CLD) was judged~     at 36 postmenstrual weeks. Infants in the study group (S/B group) received surfactant~     (Survanta®, Abbott Laboratories, North Chicago, IL; 100 mg or 4 mL/kg/dose) and Budesonide~     (Pulmicort®, AstraZeneca Pty Ltd., Australia; 0.5 mg or 1mL/kg/dose), while those in the~     control group (S group) received surfactant (Survanta® Abbott, 100 mg/kg/dose) and saline~     (1mL/kg).~   "
260002|NCT00146484|"~     The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes~     remains unknown. The purpose of this study is to determine whether a split evening injection~     regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose~     control and quality of life than twice daily insulin in children and adolescents with new~     onset diabetes.~   "
260003|NCT00146471|"~     The purpose of this study is to evaluate the efficacy and safety of levetiracetam for~     treating alcohol withdrawal syndrome (AWS) in inpatients (vs. placebo). The primary come-out~     parameter is the reduction of the total needed amount of diazepam for add-on treatment of~     acute alcohol withdrawal symptoms. The secondary come-out parameter are - safety criteria~     (AE) - reduction of alcohol withdrawal score over the days.~   "
260004|NCT00146458|"~     The objective of this study is to determinate whether the adding of FDG-PET is helpful in the~     treatment of advanced cervical cancer with concurrent chemoradiation.~   "
260005|NCT00146445|"~     The purpose of this study is to test whether a ten-session behavioral intervention for~     HIV-infected injection drug users is effective in reducing sex and injection risk behaviors~     that put others at risk for HIV infection, increasing access to or utilization of HIV primary~     health care, and increasing adherence to HIV medications.~   "
260006|NCT00146432|"~     The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a~     reduces systemic hyperinflammation, improves immune function and improves organ function in~     patients with severe sepsis and septic shock~   "
260007|NCT00146419|"~     The SUN Study is a Centers for Disease Control and Prevention (CDC)-sponsored multi-site~     prospective observational cohort study designed to better understand the incidence and~     etiology of metabolic and other complications related to effective HIV treatment and longer~     survival. The SUN Study is also providing a platform to evaluate a behavioral intervention~     designed to reduce HIV transmission through prevention counseling in routine care.~   "
260008|NCT00146406|"~     Sexually active adolescents between the ages of 10 and 19 are at extremely high risk for~     sexually transmitted diseases (STD), including HIV, and teen pregnancy.The overall goal of~     this research program is to develop, implement and evaluate integrated multi-level~     interventions to prevent STD, including HIV, and pregnancy among adolescents. The study~     includes 12 high schools and 19 of their feeder middle schools in the Los Angeles Unified~     School District and the surrounding communities. Interventions will be implemented among~     parents, health care providers, and in schools in an integrated fashion with the goal of~     improving social context factors related to health outcomes among adolescents. The evaluation~     phase will include in-school surveys with adolescents at all middle schools~   "
260009|NCT00146393|"~     The primary goal of this study is to assess the effect of People with Arthritis Can Exercise~     (PACE), a community-based group recreational exercise program, on key arthritis-related~     health outcomes among adults with arthritis.~   "
260010|NCT00146380|"~     The purpose of the study is to demonstrate that a regimen using highly active antiretroviral~     therapy (HAART) to maximally suppress maternal viral load in the late antenatal period and~     during the first six months of lactation is safe, effective and can be implemented in~     resource poor settings in order to reduce the risk of HIV transmission to the infant.~   "
260011|NCT00146367|"~     The primary goal of this study is to assess the effectiveness and feasibility of the Active~     Living Every Day Physical Activity Program (ALED) for people with arthritis. This project is~     designed to evaluate the effectiveness of the ALED program in changing arthritis-related~     health outcomes and to investigate the feasibility of conducting the ALED program in a public~     health setting.~   "
260012|NCT00146354|"~     This project aims to define the problem of results that return after patient discharge and to~     study the implementation of an Electronic Medical Record (EMR)-based system for tracking~     these results.~   "
260013|NCT00146341|"~     To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg is~     superior to telmisartan 80 mg alone in patients, who fail to respond adequately to~     telmisartan 80 mg monotherapy, in lowering seated trough diastolic blood pressure after eight~     weeks of treatment.~   "
260014|NCT00146328|"~     The objective of this study is to determine the long term safety and tolerability of multiple~     oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the~     development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other~     antiretroviral medications.~   "
260015|NCT00146315|"~     In Spain, family physician are currently recommended to prescribe an unsupervised walking~     program to their coronary heart disease (CHD) patients as a part of their cardiac~     rehabilitation program. However, there are a few family physicians who provide their CHD~     patients with supervised exercise (30 minutes of pedaling on an stationary bicycle at 60-85%~     of the peak heart rate (HR) attained at the maximal or symptom limited treadmill test, 3~     times a week) at their primary care health centers, thinking that these patients improve~     their functional capacity, quality of life, and the control of cardiovascular risk factors,~     more than walking because they can not achieve the ideal exercise intensity for maximal~     benefits by walking. This study has been designed to investigate if CHD patients get more~     health benefits with the supervised exercise program at the health center than with the~     unsupervised walking program.~   "
260016|NCT00146302|"~     The World Health Organization (WHO) currently recommends BCG vaccination at birth in~     developing countries. Pre-term infants should be vaccinated when they reach the chronological~     age of 40 weeks. Due to difficulties in establishing the correct gestational age, the~     vaccination policy for BCG in many developing countries is defined by birth weight rather~     than by gestational maturity. In the study area, low birth weight (LBW) infants (< 2500 g)~     are not supposed to be vaccinated at birth; instead the mother is asked to return for~     vaccination when the child has gained sufficient weight. BCG has marked immune stimulatory~     effects in both animal and human studies and observational studies suggest that BCG is~     associated with a non-specific reduction in mortality in areas with high infant and child~     mortality. The specific objective of the study is to examine the effect of early vaccination~     of LBW children for adverse events, purified protein derivative of tuberculin (PPD) reaction,~     scar size, morbidity, and mortality in a randomised prospective study of BCG vaccination at~     birth versus later (according to policy) among children 19 months of age in Guinea-Bissau.~     The hypothesis is that BCG vaccination of low birth weight (LBW) children at birth reduces~     infant mortality of this high-risk group by 25%.~   "
260017|NCT00146289|"~     The primary objective of this study is to determine whether MICARDIS® improves insulin~     sensitivity in overweight or obese, non-diabetic, normotensive subjects.~   "
260018|NCT00146276|"~     Primary Objective:~        -  To analyse time to tumor progression in patients cystectomized for locally advanced~          transitional cell carcinoma (TCC) of the bladder, who are not suitable for~          cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age).~          Patients are randomized to receive either adjuvant gemcitabine immediately after radical~          operation (treatment arm A) or no treatment (control arm B). Patients in the control arm~          are to be treated with gemcitabine as soon as tumor progression becomes evident~          clinically and/or radiologically.~      Secondary Objectives:~      The secondary objectives of this study are:~        -  Estimation of time-specific survival probabilities irrespective of causes of death.~        -  Assessment of toxicity and tolerability of gemcitabine~        -  Description of survival experience of patients in the control arm beyond the time of~          initiating chemotherapy.~        -  Assessment of quality of life (European Organization for Research and Treatment of~          Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30).~      Study Design:~      This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study~     using gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced~     TCC of the bladder in an adjuvant setting. The patients will receive the following treatment:~      Arm A (treatment): gemcitabine 1250 mg/m2 intravenously once a week for 2 weeks (days 1 and~     8) followed by 1-week rest period. Repeat cycle on day 22. Maximum of 6 cycles. Begin~     treatment until 3 months after radical operation (within first 6 weeks is recommended).~      Arm B (control): No immediate post-surgery treatment. Watchful waiting; treatment only~     conditionally in case of progression with gemcitabine (dose and schedule as in arm A).~   "
260146|NCT00144573|"~     This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in~     patients with RA with Renal Impairment.~   "
260019|NCT00146263|"~     Background:~      The aging of the population has lead to a significant increase in the number of older people~     suffering from cognitive impairment and dementia. The present lack of effective drug therapy~     for these conditions makes it imperative to investigate other potential therapeutic~     interventions.~      Cognitive training has been described as possibly useful in improving cognitive function in~     elderly subjects with mild impairment and early dementia. However, there have been few~     well-designed studies to date and the results are equivocal. Most studies have relied on the~     use of paper-based neuropsychological assessment instruments with limited accuracy and~     reproducibility. The investigators have developed a validated computerized neuropsychological~     assessment battery with increased test-retest reliability.~      The purpose of this study is to assess the efficacy of a computerized training program on~     cognitive function in older persons with normal cognition, mild cognitive impairment, and~     early dementia.~      Description:~      A randomized prospective AB/BA crossover study.~      Methods:~      Eligible males and females aged 60 years and older following initial computerized~     neuropsychological assessment will be randomized to receive either a 12-session computerized~     cognitive training program, or no treatment. Repeat neuropsychological assessment will be~     followed by a 4-week no treatment phase, reassessment and crossover phase. Repeat assessments~     will be performed at three and six months.~   "
260020|NCT00146250|"~     Nitrous oxide is a standard part of most anaesthetic breathing mixtures. It has often been~     assumed that it reduces the amount of oxygen reaching the lower parts of the lung. However~     the results of previous studies and of some computer modelling suggests the opposite may be~     true, and that oxygen levels in the blood are actually higher with nitrous oxide. This study~     seeks to determine whether nitrous oxide increases or decreases blood oxygen levels in~     anaesthetized patients.~   "
260021|NCT00146237|"~     About two-thirds of depressed patients respond to a standard course of serotonin specific~     reuptake inhibitor (SSRI's) within 3-4 weeks. While some clinicians advise continued watchful~     waiting after this time or switch to a different reuptake-blocker based antidepressant,~     result of such conservative strategies are usually disappointing. For severe depression~     electroconvulsive therapy (ECT) is an option and for atypical depressions monoamine oxide~     inhibitors (MAO) inhibitors often give relief at this point. A unique strategy with both~     theoretical and practical implications is lithium augmentation (Fava et al, 1994). Addition~     of lithium to SSRI failures at 3-4 weeks is consistently and sometimes dramatically found to~     be helpful. This is considered true even by those authors who advocate use of lithium under~     usual circumstances only in bipolar patients.~      Lithium in recent years has been joined as a mood stabilizer by carbamazepine and valproate.~     Phenytoin, ignored for many years as a possible anticonvulsant mood stabilizer, has been~     recently reported in double-blind controlled trials to be anti-manic (Mishory et al, 2000)~     and also prophylactic in BP disorder (Mishory et al, 2003).~      Data on mood stabilizers other than lithium as augmentors in SSRI failures are sparse.~     Carbamazepine (Steinacher et al, 2002) and valproate (Barbee et al, 2002) have been used.~     Given our recent preliminary results of phenytoin's efficacy in unipolar depression (Nemets~     et al, 2005) and its analogy to lithium as a mood stabilizer, it seems important to study~     phenytoin as a possible augmentation of SSRI failures.~      We have published a negative study previously of inositol as an augmentation of SSRI~     failures, enrolling forty-two patients over two years (Nemets et al, 1999). Antidepressant~     failures are easier to recruit from referring physicians in our center than are untreated~     patients, whom clinicians are reluctant to refer for new drug studies given the adequacy of~     standard treatment in 2/3 of them. Thus we estimate that we could enroll 20 patients per year~     in such a study. Survey of the literature of Li augmentation suggests that 40 phenytoin vs.~     40 placebo should give adequate power to detect a significant phenytoin effect if the~     phenytoin effect is similar to that of lithium.~   "
260022|NCT00146224|"~     The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is~     equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD~     receiving hemodialysis~   "
260023|NCT00146211|"~     This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement)~     signs and symptoms of Huntington disease.~   "
260024|NCT00146198|"~     Hernia repair is one of the most common operations. Whilst there are few complications, pain~     may last for several weeks and extend the period of convalescence. ALGRX 4975 is an~     ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term~     pain relief following a single administration. This study will determine whether ALGRX 4975~     can provide pain relief following hernia repair.~   "
260025|NCT00146185|"~     Minor needlestick procedures often cause significant pain and distress in pediatric patients~     yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use,~     prefilled, needle-free product that immediately delivers powdered lidocaine into the~     epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III,~     prospective, randomized, double-blind, placebo-controlled study is to investigate the~     efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3~     to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial~     will enroll approximate 504 evaluable subjects at centers located in the US.~   "
260026|NCT00146172|"~     The purpose of this study is to evaluate the safety and tolerability as well as find the~     maximum tolerated dose for HKI-272. In addition, this study will examine the effects of the~     study drug on your tumor, and how your body uses and eliminates HKI-272.~   "
260027|NCT00146159|"~     The purpose of this study is to show the dose-response relationship of three doses of~     mitoxantrone with regard to efficacy in patients with secondary progressive multiple~     sclerosis and to show the safety and tolerability of mitoxantrone in these patients.~   "
260028|NCT00146146|"~     The purposes of this study are:~        -  to determine the role of testosterone versus dihydrotestosterone with respect to the~          following physiological functions: bone metabolism, body composition, insulin resistance~          and lipid profile~        -  to determine the role of testosterone and dihydrotestosterone versus estradiol with~          respect to the following physiological functions: bone metabolism, body composition,~          insulin resistance and lipid profile~   "
260029|NCT00146133|"~     The overall purpose of this research is to determine the effect of weight loss and physical~     training on quality of life, physical function, metabolism, bone strength, body fat and~     muscle mass.~   "
260042|NCT00145964|"~     Primary biliary cirrhosis (PBC) is a disease of the liver, which predominantly affects women.~     It causes slowly progressive liver disease, which eventually causes liver failure, requiring~     a liver transplant. Several different studies of large patient cohorts indicate that the~     cause of this disease is likely due to a combination of factors including genetic and~     environmental. PBC is associated with several other autoimmune diseases - recently a gene~     has been identified to be abnormal in individuals with another autoimmune liver disease,~     namely rheumatoid arthritis. This gene usually tells the body when to switch off an immune~     response. This study plans to identify whether individuals diagnosed with PBC have a similar~     abnormality in this gene called protein Tyrosine Phosphatase.~   "
260030|NCT00146120|"~     The concept of the investigators risk-adapted multicenter treatment trial for younger adults,~     AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of~     risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after~     first induction therapy and/or high risk karyotype [abn(3q), -5/5q-, -7/7q-, abn(12p),~     abn(17p), complex]; intermediate-risk: complete remission after induction therapy and~     intermediate risk karyotype [normal, abn(11q23), abn(16q22), other rare aberrations];~     low-risk: complete remission after induction therapy and low risk karyotype [t(8;21)].~     Patients exhibiting a t(15;17) were treated in a separated trial (APL HD95). Treatment~     consists of a first induction therapy with ICE followed by a second cycle ICE in case of~     response to first induction therapy. Patients with refractory disease after first induction~     therapy are assigned to a salvage therapy with A-HAM (all-trans retinoic acid, high-dose~     cytarabine and mitoxantrone) and the search for potential hematopoietic stem cell donors is~     extended from the family to unrelated persons. All patients achieving a CR after induction~     therapy with ICE are assigned to a first consolidation therapy with HAM. For~     intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended~     during the hematological recovery after the first consolidation. Second consolidation therapy~     was stratified according to the risk definition. For high risk patients a allogeneic~     transplantation is assigned from a related or unrelated donor preferentially after a~     dose-intensified conditioning therapy. All patients with intermediate risk and an HLA-matched~     family donor are assigned to allogeneic transplantation. Intermediate-risk patients without a~     family donor and normal karyotype at diagnosis are randomized between an autologous stem cell~     transplantation and a second course of HAM. The other intermediate-risk patients are assigned~     to autologous transplantation. For low-risk patients a second course of HAM is assigned.~   "
260031|NCT00146107|"~     The purpose of this study is to determine the effect of weight loss and exercise on physical~     function, body fat and muscle mass, bone strength, and quality of life.~   "
260032|NCT00146094|"~     Osteopenia and osteoporosis are increasingly reported in HIV-infected patients, and appear to~     be more frequent than in general population. However, pathogenesis remains unclear, and~     published studies still give non concordant results.~      We therefore started a prospective study, to assess the potential role of ARV in the~     occurrence of osteopenia and osteoporosis. BMD evolution over a 2-years period of follow-up,~     will be compared between patients starting ARV therapy, and subjects without HAART (no~     indication of treatment). A correlation between BMD and several factors will be looked at~     (see below).~      This study with individual direct benefice, is conducted in 3 outpatients clinics~     (Strasbourg, Colmar, Mulhouse) in collaboration with the rheumatologic teams. 60 patients are~     planned to be included over a 3-years inclusion period~   "
260033|NCT00146081|"~     Our long-term goal is to identify new insights about effective approaches to obesity~     management and related lifestyle changes in African Americans and about factors that enhance~     or limit the response to specific treatment approaches. Our primary interest is in natural~     social support from family members or friends. However, since not all individuals seeking~     obesity treatment desire or are able to name family members or friends to participate with~     them, we will also study the benefits of social support by creating a team condition among~     individuals recruited alone.~      Specific aims are to:~        1. Recruit overweight or obese index participants together with 1 or 2 family members or~          friend co-participants who are also overweight or obese, for enrollment in a 2 year~          weight loss program;~        2. Conduct a randomized comparison of the effects, on weight loss and related behavioral~          and clinical outcomes of the index participants, of involving both index and~          co-participants (Group A) in the counseling program with those obtained when~          co-participants are not directly involved (Group B);~        3. Enroll otherwise eligible index participants who do not name co-participants in a~          parallel 2 year weight loss study; Conduct a randomized comparison of the effects, on~          weight loss and related behavioral and clinical outcomes of individual participants, of~          creating social support teams of unrelated individuals (Group C) with those obtained~          when no such teams are created (Group D).~      Primary hypotheses are that:~        1. weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in~          Group A vs. Group B;~        2. weight maintenance from 12 to 24 months will be significantly greater in Group A vs.~          Group B;~        3. weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in~          Group C vs. Group D;~        4. weight maintenance from 12 to 24 months will be significantly greater in Group C vs.~          Group D. Secondary analyses will compare the respective treatment and control groups on~          changes in diet, physical activity, and clinical CVD risk factor changes over time and~          will assess predictors of outcomes and cost-effectiveness.~   "
260034|NCT00146068|"~     The purpose of this study is to determine the safety, tolerability and efficacy of a~     combination therapy interferon beta-1a(Avonex) plus simvastatin (Zocor) vs. interferon~     beta-1a plus placebo in patients with clinically isolated syndrome suggestive of Multiple~     Sclerosis.~   "
260035|NCT00146055|"~     The purpose of this study is to determine whether a less-intensive preparative therapy~     followed by an allogeneic peripheral stem cell transplantation will provide an effective~     treatment for your disease and whether it will be associated with fewer side effects.~   "
260036|NCT00146042|"~     This is a research study which aims to improve the way that doctors determine the dose of~     chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height~     and weight. However, some patients metabolize chemotherapy faster or slower than the average~     person because of a different level of drug metabolizing enzyme in the liver. Therefore, some~     patients are either given too small or too large a dose of chemotherapy because the amount of~     enzyme is not taken into account. This research study will examine the use of a simple test,~     call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can~     metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored~     to the amount of enzyme which is available to metabolize the drug for each patient. The drug,~     docetaxel, is combined with another drug, trastuzumab (Herceptin), because at this time this~     combination appears to be promising in metastatic breast cancer research.~   "
260037|NCT00146029|"~     The purpose is to examine the original breast tumor material to see how much of a~     metabolizing enzyme (CYP3A4) is present in tumor material. The researchers want to see if~     this is in any way associated with how the patient responded to docetaxel. They also want to~     examine the genes in the tumor that are responsible for the production of CYP metabolizing~     enzymes, to see if they are normal or if they have polymorphisms, or change compared to~     'normal' CYP metabolizing enzymes.~   "
260038|NCT00146016|"~     * Adding Amantadine to standard anti-viral treatment can improve sustained response rates in~     patients with chronic hepatitis C~   "
260039|NCT00146003|"~     The purpose of this study is to demonstrate a measurable improvement on a validated scale in~     a small population of adult patients with atopic dermatitis (eczema).~   "
260040|NCT00145990|"~     To determine whether there is a difference in two different breathing tests used to detect~     asthma. Hypothesis: The Digidoser delivers less methacholine to the airways and will result~     in a higher PC20 than the value determined by the Rosenthal Dosimeter.~   "
260041|NCT00145977|"~     The purpose of this study is to determine if a new test for osteoporosis can be useful in~     monitoring treatment. We are studying a new method for examining the quality of bone by an~     experimental method of computerized analysis of radiographic images (x-ray pictures) of the~     heel.~   "
260043|NCT00145951|"~     The purpose of this research study is to assess the feasibility of a combined primary~     care/web-based depression prevention intervention. Primary care physicians (PCP) currently~     lack an alternative behaviorally-based approach to antidepressant medications for individuals~     with depression symptoms or minor depression, but who have not yet developed Major~     Depression.~      The objective of this study is to compare the feasibility and efficacy of motivational~     interviewing (MI) versus brief advice in primary care to engage adolescents with a web-based~     depression prevention intervention.~   "
260147|NCT00144560|"~     This is an open-label, clinical pharmacology study to investigate drug-drug interaction in~     patients with RA.~   "
260044|NCT00145938|"~     The purpose of the study is to see if the administration of sildenafil (Viagra) in patients~     with portopulmonary hypertension could be a safe and effective treatment.~      Portopulmonary hypertension (PTPH) is a special type of pulmonary hypertension. Pulmonary~     hypertension is high blood pressure in the pulmonary arteries that carry unoxygenated blood~     from the right ventricle of the heart to the lungs. Pulmonary hypertension results from~     constriction, or tightening, of the blood vessels that supply blood to the lungs.~     Consequently, it becomes difficult for blood to pass through the lungs, making it harder for~     the heart to pump blood forward. This stress on the heart leads to enlargement of the heart~     and eventually fluid can build up in the liver and tissues, such as in the legs. Affected~     patients can sometimes notice increasing shortness of breath and dizziness.~      There is a growing body of evidence suggesting a potential therapeutic role for this~     sildenafil in patients with primary pulmonary hypertension. Studies are ongoing regarding~     this area.~      Our hypothesis is that chronic oral sildenafil will successfully reduce pulmonary artery~     pressures by at least 25% (reduction in mean pulmonary artery pressure) and could be an~     effective treatment for PTPH, especially in candidates for liver transplantation~      Primary Hypothesis To measure the effects of a single dose of sildenafil on pulmonary~     arterial pressure in patients with PTPH~      Secondary Hypothesis To measure the effects of chronic (3 month) treatment with sildenafil on~     pulmonary arterial pressure, safety, and tolerability in patients with PTPH~   "
260045|NCT00145925|"~     The purpose of this study is to provide information on the risks and benefits of routine~     blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood~     glucose levels, in patients with Type 2 diabetes at high risk of cardiovascular events. The~     major outcomes of the study will be cardiovascular events (heart attack, stroke or dying as a~     result of cardiovascular disease), as well as new or worsening diabetic eye and kidney~     disease.~   "
260046|NCT00145912|"~     The purpose of this research is to evaluate the feasibility of an interview between an~     adolescent / young adult and a PCP (Primary Care Physician).~   "
260047|NCT00145886|"~     The purpose of this study is to determine how treatment with a new medication, recombinant~     human parathyroid hormone (rhPTH) affects calcium balance and bone strength.~   "
260048|NCT00145873|"~     The purpose of this study is to look at the safety and effectiveness of longer term~     intravenous (IV) infusion of the study drug, nesiritide in patients with acutely~     decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human~     hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for~     short-term inpatient IV treatment of acutely decompensated chronic heart failure.~      Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient~     setting, is a safe treatment for refractory Class III & IV chronic heart failure due to~     systolic or diastolic dysfunction, regardless of renal function when administered over a~     12-week period.~      Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall~     condition of patients with chronic heart failure. These mechanisms include reducing~     hospitalizations when compared with the previous six months, improving symptoms as measured~     by the Minnesota Living with Heart Failure short questionnaire, and improving functional~     capacity as measured by 6-minute walk testing.~      Corollary #2: Nesiritide infusion will be associated with a statistically significant~     decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving~     placebo infusions.~   "
260049|NCT00145860|"~     The purpose of this study is to assess whether patients with colorectal cancer understand~     that their first-degree relatives are at increased risk of getting the cancer themselves and~     therefore should be screened early. Among patients who do understand the risks to their~     family, we plan to determine who they identify as the source of their information and whether~     they have acted upon this information and advised family members to be screened. We~     hypothesize that many patients with colorectal cancer do not have a correct understanding of~     the risks to their first-degree relatives and the recommendations that they be screened~     early.~      If this hypothesis is shown to be true, it can be used to direct improved and more diligent~     patient education. This, in turn, will hopefully increase the low screening rates among~     first-degree relatives, and, thereby, save lives in this high-risk population.~   "
260050|NCT00145847|"~     The primary purpose of this study is to determine whether naltrexone is effective in the~     treatment of alcohol dependence and abuse in patients with schizophrenia and schizoaffective~     disorder. Hypotheses are as follows:~      hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use.~      hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show~     reductions in severity of psychiatric symptoms and utilization of inpatient and emergency~     psychiatric services.~      hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will~     correlate positively with alcohol use.~   "
260051|NCT00145834|"~     The purpose of this study is to investigate if a postnatal public health breastfeeding~     intervention relying on the importance of the psychosocial factors can prolong the period~     with exclusive breastfeeding duration among mothers who want to breastfeed.~   "
260052|NCT00145808|"~     Based on the inaccuracies of the current classification scheme for inflammatory bowel disease~     (IBD), the failure of surgical pouches and the findings of retrospective observational trials~     to date, we hypothesize that a significant proportion of patients with UC will have small~     bowel involvement that will result in a change in diagnosis to CD or the recognition of a new~     phenotype of IBD. The aim of this study is to determine the prevalence of small bowel~     pathology in patients diagnosed with UC using WCE. This information will aid in the current~     efforts to re-classify IBD using improved endoscopic and imaging technologies, genetic~     information and serologic information.~   "
260077|NCT00145483|"~     Meniere's disease affects a person's sense of balance. An attack can last 20 minutes to 2~     hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation~     of fullness in the affected ear and may be associated with nausea and vomiting. One~     hypothesis is that Meniere's disease is caused by the excessive accumulation of fluid in the~     balance tubes within the inner ear. Sildenafil may alleviate the symptoms due to its~     vasodilatory activity. The purpose of this study is to assess the safety and efficacy of~     sildenafil (Viagra) compared with placebo on symptoms during one acute attack.~   "
260078|NCT00145470|"~     This is a 12-week study that will test the safety and efficacy of asenapine when used in~     addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I~     Disorder.~   "
260053|NCT00145795|"~     Our goal is to determine if a change in therapy to one containing Kaletra can improve the~     immune response in patients who have previously been immune partial responders or~     non-responders. We also are interested in knowing if this agent improves immune response by~     affecting cluster of differentiation 4 (CD4) + T cell death (apoptosis) or by further~     inhibiting (preventing) ongoing, low-level, viral replication to levels below detection by~     current viral load measurements. This will help us understand why immune responses to~     effective antiretroviral therapy are so different and help determine some possible guidelines~     for managing patients with poor immune responses.~      Hypothesis: Patients with poor immune responses to HAART who receive Kaletra in place of~     their current PI or Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) while continuing~     their current 2 NRTI backbone will have improved immune response to therapy compared to~     patients who continue their current regimen.~   "
260054|NCT00145782|"~     The objective of The Ebeltoft Health Promotion Project is investigate the effect of~     multiphasic preventive health screenings and discussions with general practitioners of a~     random population of patients in primary care.~      Outcome parameters are the cardiovascular risk profile, number of health care contacts, life~     years gained, direct costs, i.e. health care costs, and total cost, i.e. including~     productivity costs.~   "
260055|NCT00145769|"~     This is a multi-centre randomised trial comparing long course (LC) preoperative~     chemoradiation with short course (SC) preoperative radiotherapy for patients with localised~     T3 rectal cancer.~   "
260056|NCT00145756|"~     Cardiovascular disease is a leading cause of death and disability worldwide, and blood~     pressure is a leading determinant of this risk. To date, strategies for blood pressure~     lowering have focused on drug treatment but dietary interventions such as reducing sodium~     intake and increasing potassium intake may also be effective. Such interventions may be~     particularly suitable for low- and middle-income countries in which significant dietary~     changes may be more easily achieved. This study will test the effect of a salt substitute on~     blood pressure, among individuals at high-risk from cardiovascular disease in Northern China.~   "
260057|NCT00145743|"~     Quality of Life-Diagnostics and -Therapy in Individual Patients with Breast Cancer.~      A randomized study including 200 patients, 5 clinics and 43 general practitioners as~     coordinating doctors for quality of life therapies.~   "
260058|NCT00145730|"~     The primary aim of this randomised trial is to determine the effects of a short~     peri-operative course of treatment with a non-steroidal anti-inflammatory drug (NSAID),~     ibuprofen, on the long-term consequences of ectopic bone formation in patients undergoing~     elective total hip replacement surgery. The specific hypotheses to be tested at that 6 to 12~     months after surgery, patients assigned post-operative ibuprofen will have less self-reported~     pain and physical disability, greater health-related quality of life and reduced ectopic bone~     formation compared with those assigned placebo.~   "
260059|NCT00145717|"~     The aim of this study is to see if plant sterols are effective at lowering blood cholesterol~     levels in Chinese people. The study will be done with Chinese colleagues based at Peking~     University in Beijing with whom our Institute has a well-established collaboration. The study~     will be randomised, placebo-controlled and double-blind. The total study period for~     participants will be an average of seven weeks comprised of a two-week placebo run-in period~     and a five-week follow-up on randomised treatment. Randomised treatment will comprise either~     placebo, low- or standard-dose plant sterol. The primary outcome for the study will be blood~     cholesterol levels.~   "
260060|NCT00145704|"~     The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given~     to growth hormone deficient patients (regardless of current growth hormone replacement~     therapy status and without changing that status) significantly increases total body bone~     mineral density during an eighteen month period of treatment combined with calcium and~     Vitamin D when compared to calcium and Vitamin D treatment alone.~   "
260061|NCT00145691|"~     We intend to conduct a phase III b trial to verify Oxcarbazepine's effect in agitation and~     aggression in patients with dementia. We designed the study as a randomized, double-blind,~     placebo-controlled multi center trial. Hundred patients will be included. The treatment~     period will be eight weeks, with a further follow up of four weeks.~      The primary outcome measure will be the reduction in aggression and agitation as measured by~     means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home~     Version). Secondary outcomes are reduction in aggression as measured by BARS (Behavior~     Agitation Rating Scale)and reduction in the burden to health-care personnel as measured by~     NPI-NH.~   "
260062|NCT00145678|"~     The purpose of the study is to determine the feasibility and effectiveness of a modified form~     of psychodynamic psychotherapy for persons suffering from co-occurring borderline personality~     disorder and an alcohol use disorder.~   "
260063|NCT00145665|"~     The aim of the study is to obtain information on FLT used in a PET-scan as a marker for the~     proliferation of colorectal liver metastases, so that the risk of recurrence can be~     identified in a noninvasive way, concerning patients with resectable colorectal liver~     metastases.~      The hypothesis of this study is that a higher uptake of FLT in the liver metastases has a~     good correlation with the proliferation rate of the metastases. This rate is related to the~     risk of recurrence.~   "
260064|NCT00145652|"~     This is a multi-center open label, randomized phase-3 study with stratification according to~     diagnosis and baseline serum-EPO level. The correction of mild or moderate anemia and the~     effect on iron kinetics by the rHuEPO treatment with or without intravenous iron~     supplementation in anemic patients with LPD not receiving antineoplastic therapy will be~     studied. The study will be performed according to the ICH-GCP guidelines. In order to be~     eligible, the patient must consent in writing that he/she agrees to participate in the study.~     The patient recruitment period is estimated to be no longer than 18 months.~   "
260065|NCT00145639|"~     This trial (OS99) evaluates the use of ifosfamide, carboplatin, and doxorubicin in an~     up-front window before surgery for localized and resectable osteosarcoma. High-dose~     methotrexate, which may interfere with the dose-intensive delivery of other agents, is~     eliminated from the treatment of localized disease. The primary objective is to compare the~     response rate of pre-surgical chemotherapy comprised of ifosfamide, doxorubicin, and~     carboplatin to that obtained with ifosfamide and carboplatin in the St. Jude OS-91 trial for~     patients with non-metastatic resectable osteosarcoma. We hypothesize that the histologic~     response rate will be improved by the addition of one course of pre-operative chemotherapy on~     this trial compared to the previous OS-91 trial.~   "
260066|NCT00145626|"~     Recent studies of conventional chemotherapy for infants with high-risk hematologic~     malignancies show that the long-term disease-free survival is low. Although blood and marrow~     stem cell transplantation using an HLA identical sibling has improved the outcome for these~     children, less than 25% have this donor source available. Another option is haploidentical~     transplantation using a partially matched family member donor (i.e. parental donor).~      Although haploidentical transplantation has proven curative for some patients, this procedure~     has been hindered by significant complications, primarily regimen-related toxicity including~     infection and graft versus host disease (GVHD). Building on prior institutional trials, this~     study will provide patients a haploidentical graft depleted of T lymphocytes using the~     investigational device, CliniMACS selection system. One week after the transplant procedure,~     patients will also receive an infusion of additional donor derived white blood cells called~     Natural Killer (NK) cells in an effort to decrease risks for rejection of the graft, disease~     relapse, and regimen related toxicity. The primary objective of the study is to evaluate 1~     year survival in infants with high risk hematologic malignancies who receive this study~     treatment.~   "
260067|NCT00145613|"~     Relapsed disease is the most common cause of death in children with hematological~     malignancies. Patients who fail high-intensity conventional chemotherapeutic regimens or~     relapse after stem cell transplantation have a poor prognosis. Toxicity from multiple~     therapies and elevated leukemic/tumor burden usually make these patients ineligible for the~     aggressive chemotherapy regimens required for conventional stem cell transplantation.~     Alternative options are needed. One type of treatment being explored is called haploidentical~     transplant.~      Conventional blood or bone marrow stem cell transplant involves destroying the patient's~     diseased marrow with radiation or chemotherapy. Healthy marrow from a donor is then infused~     into the patient where it migrates to the bone marrow space to begin generating new blood~     cells. The best type of donor is a sibling or unrelated donor with an identical immune system~     (HLA match). However, most patients do not have a matched sibling available and/or are~     unable to identify an acceptable unrelated donor through the registries in a timely manner.~     In addition, the aggressive treatment required to prepare the body for these types of~     transplants can be too toxic for these highly pretreated patients. Therefore doctors are~     investigating haploidentical transplant using stem cells from HLA partially matched family~     member donors.~      Although haploidentical transplant has proven curative in many patients, this procedure has~     been hindered by significant complications, primarily regimen-related toxicity including~     graft versus host disease (GVHD), and infection due to delayed immune reconstitution. These~     can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens~     when the donor T cells recognize the patient's (the host) body tissues are different and~     attack these cells. Although too many T cells increase the possibility of GVHD, too few may~     cause the recipient's immune system to reconstitute slowly or the graft to fail to grow,~     leaving the patient at high-risk for infection. However, the presence of T cells in the graft~     may offer a positive effect called graft versus malignancy or GVM. With GVM, the donor T~     cells recognize the patient's malignant cells as diseased and, in turn, attack these diseased~     cells.~      For these reasons, a primary focus for researchers is to engineer the graft to provide a T~     cell depleted product to reduce the risk of GVHD, yet provide a sufficient number of cells to~     facilitate immune reconstitution, graft integrity and GVM.~      In this study, patients were given a haploidentical graft engineered to with specific T cell~     parameter values using the CliniMACS system. A reduced intensity, preparative regimen was~     used to reduce regimen-related toxicity and mortality. The primary goal of this study is to~     evaluate overall survival in those who receive this study treatment.~   "
260068|NCT00145600|"~     With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is~     to maintain the currently successful cure rate and reduce treatment related side effects and~     long term toxicity. The main purpose of this study is to estimate the event free survival of~     patients treated with risk-adapted therapy compared to historical controls.~   "
260069|NCT00145587|"~     Malignant infantile osteopetrosis (MIOP) is a rare fatal genetic disorder that is~     characterized by the bone's inability to regulate remodeling. The only curative therapy is~     hematopoietic stem cell transplantation. Stem cells provided from an HLA identical matched~     sibling donor is the standard of care, but not feasible for the majority of patients. In~     addition, due to the potentially rapid progression of this disease, the time to identify a~     suitable HLA matched unrelated donor is not optimal. Therefore this study is designed to test~     the hypothesis that children with osteopetrosis can properly engraft hematopoietic stem cells~     that are donated from a partially matched parental donor, or haploidentical stem cell donor~     that are processed on the investigational device, CliniMACS selection system.~   "
260070|NCT00145574|"~     This study will evaluate the lipid-lowering effect and safety of colesevelam therapy~     administered to heterozygous familial pediatric patients 10 through 17 years of age who are~     on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin,~     simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.~   "
260071|NCT00145561|"~     Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women~   "
260072|NCT00145548|"~     The Spiration Intra-Bronchial Valve is intended for use as a minimally invasive treatment for~     severe emphysema, using standard bronchoscopy. The valve is designed to limit airflow to a~     selected portion of the lung, producing a reduction in lung volume, which may improve~     pulmonary function in patients with emphysema.~   "
260073|NCT00145535|"~     Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure~     in patients with poorly controlled intraocular pressure on maximally tolerated medical~     therapy or prior failed laser trabeculoplasty.~   "
260074|NCT00145522|"~     This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone~     in comparison with tibolone on the breast metabolic markers, in particular the total~     insulin-like growth factor-1 (IGF-1), in postmenopausal women.~   "
260075|NCT00145509|"~     The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety~     and tolerability of asenapine in bipolar I disorder subjects who had not completely responded~     to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute~     manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008~     (NCT00145470). The safety comparison was between the group receiving lithium or VPA and~     placebo against the group receiving lithium or VPA and asenapine, with the caveat that all~     subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.~   "
260076|NCT00145496|"~     Treatment with conventional antipsychotics such as haloperidol has little effect or may~     sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and~     poor rapport) of schizophrenia. The newer atypical antipsychotics agents, such as~     olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The~     purpose of this study is to compare an investigational compound (asenapine) with a marketed~     agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of~     schizophrenia for 6 months. Patients completing this study may be eligible to participate in~     an extension 6 months of treatment. Patients are required to have stable symptoms prior to~     entry into study.~   "
260079|NCT00145457|"~     To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1~     changes, on the 24 months growth response to 2 different doses of GH in patients with~     conventional GH deficiency.~   "
260080|NCT00145444|"~     This study intends to compare novel antipsychotics ziprasidone and olanzapine, to confirm the~     findings of an open study -where stable patients receiving olanzapine switched to~     ziprasidone- which showed maintenance of clinical effect with improvements in all domains of~     cognitive function at 6 weeks (Daniel, 1999). Direct comparison of the two agents in a~     well-controlled double-blind fashion will allow an evaluation of the effect on cognitive~     function in the short and long-term management of patients with recent-onset schizophrenia,~     schizoaffective and schizophreniform disorder.~   "
260081|NCT00145431|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects~     with a rare genetically known disorder of high cholesterol and triglyceride levels.~   "
260082|NCT00145418|"~     It has been accepted and proven that patients with unresectable lung cancer can benefit from~     systemic chemotherapy. Traditional platinum-based therapy has significant side effects.~     Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of~     this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity~     profile and to determine the response rate to this study drug combination.~   "
260083|NCT00145405|"~     The morbidity and the mortality in acromegalic patients closely correspond to growth hormone~     (GH) levels and therefore efficient long-term treatment is important.~      Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH~     levels in about 80% of patients with microadenomas, but less than 50 % of patients with~     macroadenomas respond sufficiently to surgery alone. In most patients, additional medical~     therapy is therefore needed.~      Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or~     radiotherapy can not lead to normal GH and IGF-I levels. Lanreotide Autogel (LAN) is a new~     formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be~     injected intramuscularly or deep subcutaneously once every 28 days.~      Aim~      The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and~     IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which~     treatment modality resulted in the lowest possible IGF-I and GH levels and the highest~     patient satisfaction.~   "
260084|NCT00145392|"~     In this study, we will clarify the degree of insulin resistance and characterise muscle~     glucose metabolism and gene expression in a group of overweight healthy women. The study will~     clarify how overweight influences body glucose metabolism and thereby in the long-run~     increases the risk for developing type 2 diabetes. Moreover, the study may clarify why some~     overweight women develop hormone disorders and diabetes while others remain healthy.~      The study is essential as many patients suffer from diseases aggravated by overweight. In~     addition, a genetic disposition for diabetes or polycystic ovary syndrome may give rise to~     the disease if the patient gains weight. It is therefore important that weight-matched~     control subjects are included in projects with overweight patients.~      This clinical trial includes 10 overweight women with regular hormones and normal level of~     male sex hormone. The patients included must be healthy, take no medications influencing the~     study results. The subjects must take no contraceptive pills or receive any other hormone~     treatment.~      In connection with the investigation, the following will be carried out on all patients:~     clinical examination, blood tests, hyperinsulinaemic euglycaemic clamp, muscle biopsies, bone~     scan.~      The purpose of the study is to gain more knowledge of how overweight influences women's risk~     of developing hormone diseases and diabetes.~   "
260085|NCT00145379|"~     Patients suffering from diabetes through many years have a risk of developing late diabetic~     complications including changes in eyes, kidney, vessels and nerves. Late complications can~     be postponed or avoided when assuring a good diabetes control, i.e. sensible diet, exercise,~     frequent blood glucose measurements and a good medical treatment.~      Blood glucose regulation depends on two different factors i.e. the insulin need of the body~     and the amount of insulin in the body. The amount of insulin, in blood, is decided by the~     amount of insulin infused daily, whereas the insulin need depends on the patient's weight,~     physical activity and diet. Overweight type 2 diabetes patients have a large insulin need and~     especially this need is decisive for their development of diabetes. If these patients are~     treated with Metformin, blood glucose decreases and the result is an easier weight loss for~     the patient. Especially, when these patients take this drug, the development of late diabetic~     complications, especially arteriosclerosis, can be avoided or postponed.~      Whether these favourable effects of Metformin are also present in type 1 diabetic patients~     remains to be fully clarified, but some studies have indicated that this is the case. This~     results in a better regulation of diabetes on a smaller insulin dose than the one given to~     the patients before.~      Metformin probably takes effect by increasing the glucose uptake in muscles and by reducing~     the hepatic glucose production. The drug usually has no side-effects, but some patients do,~     however, suffer from abdominal pain, small tendency to nausea, loose defaecation and a~     metallic taste in the mouth. These side-effects are often temporary.~      Project description~      In total, 50 type 1 diabetic patients are offered to participate in the project. All are from~     the outpatient clinic at the Department of Endocrinology. The project lasts 7 months divided~     as follows:~        1. An introductory period of one month introducing an optimisation of the insulin treatment~        2. A 6 month period (in which neither the patients nor the treating doctor know which~          medication is given) with either T. Metformin treatment twice daily or T. Placebo (lime)~          twice daily together with the usual insulin treatment four times daily.~      Choice of either T. Metformin or T. Placebo will be made by draw, and as stated above, the~     drug type will be unknown for both the patient and the treating doctor in order to make sure~     that the investigation is as objective as possible.~      Throughout the examination period, the patients are asked to measure blood glucose four times~     daily, i.e. before main meals and before bed time. These values will be used for regulating~     the fasting insulin dose with help from the treating doctor, and for adjusting the daily~     insulin dose. During the first and the last two days of the examination period we will also~     ask the patients to measure blood glucose at 03h00 for two days. Those diurnal profiles will~     be included in the evaluation of the blood glucose control during the treatment period.~     Furthermore, the patients' blood pressures are determined during 24 hours before and after~     the 6 months' treatment period. This will be carried out automatically by means of a blood~     pressure cuff around the arm connected to a small apparatus registering the values during 24~     hours. The apparatus can be taken home after installation at the outpatient clinic and can be~     carried around in a belt around the waist until next day where the apparatus will be~     dismantled.~      At the first and the last of 5 outpatient visits, blood tests will be taken (for evaluation~     of the long-term blood glucose, kidney, liver, insulin and fat in blood) and nocturnal urine~     must be collected and disposed in order to evaluate protein secretion and thereby kidney~     function.~   "
260086|NCT00145366|"~     The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine~     treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter.~     It is an introduction of a novel principle, based on prospective, randomized double blind~     investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size~     (measured by ultrasonography), both in healthy individuals and in patients with nontoxic~     nodular goiter. Thus, the investigations are divided into 4 categories listed below:~        1. Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human~          TSH for the effect of radioiodine in nontoxic multinodular goiter.~        2. Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant~          human TSH for the effect of radioiodine on thyroid size and function in patients with a~          very large (>100 ml) nontoxic or toxic goiter.~        3. Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume~          in healthy individuals? A randomized double-blind cross-over trial.~        4. Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume~          in healthy individuals and in patients with multinodular non-toxic goiter? A randomized~          double-blind cross-over trial.~           As a final note we investigate, in a pilot-study;~        5. The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism~          treated with continuous block-replacement therapy.~   "
260087|NCT00145353|"~     The main purpose of the study is to investigate the reason for the reduced number of~     hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin~     Aspart at meals together with NPH insulin mornings and evenings, and when, in another period~     of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and~     when the patients in both periods simultaneously take extra insulin at meals if high blood~     glucose values are found before meals.~   "
260088|NCT00145340|"~     In this study, the investigators wish to investigate how pioglitazone treatment effects~     hirsute women. Hirsute women are often overweight and have an increased amount of male sex~     hormone in their blood. Their blood tests show frequent changes corresponding to the changes~     seen in diabetic patients.~      Pioglitazone is a drug used for increasing the insulin sensitivity in diabetic patients.~     Previous studies showed that this drug is able to decrease the level of insulin in blood in~     hirsute women. Moreover, the level of male sex hormones is reduced during this treatment. The~     drug has only been marketed for few years, and no investigations have been carried out as to~     the reaction of other hormones, e.g. growth hormone and stress hormone, using this treatment.~      This clinical trial includes 30 strongly hirsute women. The patients are randomized to either~     placebo or an active drug. The treatment period is 16 weeks. The patients included must be~     healthy and take no medicine possibly changing the results of the study. The patients must~     take no contraceptive pills or receive any other hormone treatment.~      In connection with the investigation, the following will be carried out on all patients:~     glucose tolerance test, clinical examination, blood tests, measurement of stress hormones and~     sex hormones, hyperinsulinaemic euglycaemic clamp test, muscle biopsies and bone scan.~      This examination programme will be carried out before start of pioglitazone or placebo~     treatment and again after 16 weeks of treatment. The examinations require 2½ days of~     hospitalization.~      The purpose of the study is to gain more knowledge of the reasons for hirsute women to grow~     more hair than normal women. The study will show whether pioglitazone treatment can reduce~     the amount of male sex hormone in blood and how the level of stress hormone and growth~     hormone is changed when reducing the amount of insulin in blood.~   "
260089|NCT00145327|"~     This extension study is designed to assess the long term safety and efficacy of zoledronic~     acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301~     (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year~     core study ended. Baseline is the same as Year 3.~   "
260090|NCT00145314|"~     The main objective of this trial is to explore the effect of combining an established~     chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin~     (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of~     metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab,~     in which FLOX is given continuously or intermittently, compared to standard FLOX without~     cetuximab.~   "
260091|NCT00145301|"~     This trial will compare the retention on treatment (based on the rate of patients staying on~     treatment for 1 year) of patients suffering from primary osteoarthritis using two different~     doses of lumiracoxib (100 mg od or 100 mg bid) or using celecoxib (200 mg od)~   "
260092|NCT00145288|"~     Hirsutism is the presence of terminal hairs in a male-like pattern in females, due to~     elevated male hormone levels. Females with hirsutism are often overweight and have metabolism~     disturbances as insulin resistance and impaired glucose tolerance.~      The previous studies showed that patients with hirsutism (especially them with polycystic~     ovarian syndrome (PCOS)) have an increased risk to develop type 2 diabetes mellitus on the~     background of insulin resistance / hyperinsulinemia: 30-35 % of females with PCOS had~     impaired glucose tolerance and 5-10 % of them diabetes. Hyperinsulinemia increases the risk~     to develop dyslipidemia and cardiovascular diseases.~      A previous study in our department who included 340 females with hirsutism (210 with~     idiopathic hirsutism and 134 with PCOS) showed that 6.6% of them had diabetes and 55% insulin~     resistance.~      There were only few long-term follow up studies of patients with hirsutism concerning their~     risk to develop diabetes. As far as we now, such studies on patients with idiopathic~     hirsutism are not available until now.~      Hirsutism is been treated with low dose oral contraceptives, which are suppressing androgen~     production. This treatment can also influence the risk to develop diabetes and atheromatosis.~     The previous studies showed that the low dose oral contraceptives had modest influence on the~     lipid profiles and carbohydrate metabolism in patients with hirsutism, but increased the risk~     to develop coronary disease.~      Aim~        -  To study and quantify, in patients with hirsutime, the risk to develop type 2 diabetes~          on the background of insulin resistance / decreased glucose tolerance and atheromatosis~          on the background of insulin resistance / hypercholesterolemia.~        -  To clarify the effect of P-pills on patients hair growth and metabolism.~   "
260093|NCT00145275|"~     Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such~     as headache, fever, muscle aches, and pains, may occur following the infusion. This study~     will investigate the use of over-the-counter medicines to improve these symptoms.~   "
260094|NCT00145262|"~     Clinical studies have established that implantation of bone marrow mononuclear cells~     (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases~     collateral vessel formation. We, the investigators at Nagoya University, further investigated~     the efficacy and safety of autologous implantation of BM-MNCs or PB-MNCs in patients with~     severe ischaemic limbs who have no other alternative therapeutic options. We also examined a~     potential limiting factor which reduced the efficacy of therapeutic angiogenesis using cell~     transplantation (TACT).~   "
260095|NCT00145249|"~     This study will examine the effectiveness and safety of a combination treatment for~     cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency~     syndrome (AIDS) in the developing world. The standard initial treatment includes two~     medications: amphotericin B for 2 weeks followed by 8 weeks of fluconazole. This study will~     look at whether study participants recover more quickly and have fewer side effects if they~     are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as~     compared to the standard treatment. Participants will be followed for approximately 6 months~     from the time they are enrolled into the study.~   "
260096|NCT00145236|"~     The purpose of this study was to determine if nebivolol is superior to placebo for the~     treatment of elevated blood pressure in Black patients with mild to moderate hypertension.~   "
260097|NCT00145223|"~     Wuchereria bancrofti, is a mosquito-transmitted parasite that causes deforming lymphatic~     filariasis in the tropics. Improved treatment methods have led to new thinking that it should~     be possible to interrupt transmission and eliminate this major public health problem by~     repeated, annual cycles of mass treatment with new single dose combination drug regimens.~     Egyptian villages involved in the study will be surveyed. Household members above 4 years of~     age will be tested for filariasis. Also, children in the first year classes of primary~     schools (5 to 6 years of age) will be tested for parasite infection. Village populations will~     be treated for filariasis as part of the MOH national filariasis elimination program.~     Children under age 5, pregnant women, and people with severe underlying illness are excluded~     from the program.~   "
260098|NCT00145210|"~     The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart~     rate in African American patients with hypertension.~   "
260099|NCT00145197|"~     The purpose of this study is to determine if a physician-centered intervention will help~     women with early stage breast cancer receive appropriate treatment.~   "
260100|NCT00145184|"~     The purpose of this study is to see whether children who take vitamins along with the~     standard medicine for tuberculosis (TB) recover better and quicker than children who take~     only the standard medicine for TB. Four hundred children ages 6 weeks-5 years, who have been~     diagnosed with tuberculosis, will be enrolled. They will be followed for 2 months after~     treatment for TB. Study procedures may include blood draws, Tuberculin Skin Tests, body~     measurements, gastric aspirates (removal of stomach fluid), physical exams, and~     questionnaires. This study will occur in Tanzania.~   "
260101|NCT00145171|"~     APO303 is a sub-study of patients enrolled in APO401 (the long-term open label safety~     protocol) and was designed to evaluate adverse events, particularly blood pressure drops when~     standing up during first dose in patients who have not been exposed to apomorphine before.~   "
260102|NCT00145158|"~     The purposes of this study are to describe the immune response to individual peptides after~     immunization with a combination of 8 peptides and Montanide ISA-51; to determine the safety~     of this vaccine and; to document the tumor response to the vaccine.~   "
260103|NCT00145145|"~     The purposes of this study are to determine whether immunization with the MAGE-3.A1 peptide~     mixed with CpG 7909 results in a detectable immune response; to determine the safety of this~     vaccine and; to document the tumor response to the vaccine.~   "
260104|NCT00145132|"~     Aim of this project is to investigate the effects of escitalopram on monoamine transporter~     (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological~     parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients~     with depression.~   "
260105|NCT00145119|"~     The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes~     in patients with acute myocardial infarction with depressed ventricular function and to~     determine the predictive value of several invasive and non-invasive risk markers for~     life-threatening arrhythmia~   "
260106|NCT00145106|"~     The purpose of the study is to compare the efficacy of three maintenance regimens (topical~     tazarotene, oral minocycline, or both) in sustaining improvement in acne.~   "
260107|NCT00145093|"~     The purpose of this study is to determine whether chromium (yeast), is effective in improving~     glycaemic control and insulin resistance.~   "
260108|NCT00145080|"~     The purpose of this study is to assess the impact of disease management interventions on bone~     mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at~     high risk for osteoporosis.~   "
260109|NCT00145067|"~     The purpose of the study is to evaluate the impact disease management interventions in~     treatment compliance among post-fracture and osteoporosis patients.~   "
260110|NCT00145054|"~     We propose to conduct a pilot trial of an Internet-only depression skills training program~     for adolescents and young adults. The intervention, MoodHelper.org already exists and has~     been tested in two pilots. In this third pilot, we plan to use an enriched minority sampling~     frame to mail 3,000 to 6,000 invitational brochures to KPNW members aged 14 to 24, with a~     enrollment target of 150. Interested members will go to the study Internet site, and if they~     choose to participate, complete the online consent and assessment battery (used in the~     previous pilots). Participants will be randomly assigned by the site’s software to one of two~     conditions: (1) the “Intervention” condition, with complete access to the SADhelper.org web~     site or (2) the Usual Care” condition, with access to all Internet sites and KPNW health~     care, but with no access to the therapeutic portion of the SADhelper site. All participants~     (those with and without access to the research intervention) will be reminded by e-mail and,~     if necessary, by telephone to return to the web site and complete follow-up questionnaires~     four, eight, sixteen, and thirty-two weeks after enrolling in the study.~   "
260111|NCT00145041|"~     The purpose of this study is to see how vincristine, when placed in an oil droplet called a~     liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body~     (pharmacokinetics). This study will also assess the safety of VSLI and to see if VSLI will~     slow the growth or shrink tumors in patients with metastatic melanoma that has resulted in~     liver impairment, and who have relapsed after previous therapies.~   "
260112|NCT00145028|"~     To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.~   "
260113|NCT00145015|"~     The purpose of the study is to determine whether increasing the dietary intake of n-3 fatty~     acids by the consumption of oil-rich fish reduces the risk of developing colorectal cancer.~   "
260114|NCT00145002|"~     To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in~     terms of survival benefit.~   "
260115|NCT00144989|"~     To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage~     small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent~     accelerated hyperfractionated thoracic irradiation.~   "
260116|NCT00144976|"~     The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an~     inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who~     are carriers of head and neck epidermoid carcinoma.~   "
260117|NCT00144963|"~     The purpose of this study is to find the highest safe dose and to assess the anti-tumor~     effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory~     acute lymphoblastic leukemia (ALL).~   "
260118|NCT00144950|"~     This study will compare VATS versus chest drain insertion and urokinase in the treatment of~     childhood empema by a randomised prospective study.~   "
260119|NCT00144937|"~     The purpose of this study was to evaluate whether an intensified multifactorial intervention~     program about cardiovascular risk factors in subjects with peripheral arterial disease (with~     and without diabetes mellitus), can improve the control of these factors (mainly~     hypercholesterolemia and hypertension) in relation to the habitual care~   "
260120|NCT00144924|"~     Comparison of open and laparoscopic pyloromyotomy~   "
260121|NCT00144911|"~     This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary~     Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the~     clinic 10 times. Subjects will be given breathing tests and will record their breathing~     symptoms daily on diary cards. All study related medicines and medical examinations will be~     provided at no cost. The two drugs used in this study have been approved by the FDA for use~     in patients with COPD.~   "
260122|NCT00144898|"~     Sentinel node resection appears as a promising advancement in the surgical treatment of~     breast cancer.~      The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new~     surgical method with a classical method in patients having a negative sentinel node.~      The duration of the follow-up is 5 years.~   "
260123|NCT00144885|"~     Patients with definite or possible infective endocarditis are included in this protocol, at~     the acute phase of the disease.~   "
260141|NCT00144638|"~     Procalcitonin, a marker of infection has often been compared to clinical pictures as for~     instance clinical sepsis. This has given som problems in the interpretation of these~     studies, because of the lack of good Gold Standards for clinical sepsis. We have decided to~     investigate the development from day to day of Procalcitonin in the blood of intensive care~     patients, compared to the mortality.~      Hypothesis: Procalcitonin increase after reaching a certain level predicts mortality in the~     Intensive Care Unit.~   "
260142|NCT00144625|"~     This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy~     and PK of MRA in patients with pJIA who participated in Study MRA318JP.~   "
260124|NCT00144872|"~     This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the~     treatment of newly-diagnosed typical absence seizures. Subjects will be children and~     adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study~     will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation~     Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing~     doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by~     hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At~     that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not~     achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified~     dose escalation will be discontinued from the study. During the Maintenance Phase, the~     investigators will use their best effort to maintain the subjects at the efficacious dose~     reached. If the subjects have unacceptable side effects or inadequate seizure control, the~     doses of study drug can be increased or decreased as specified in the dosing schedule. Safety~     will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine~     levels. Health outcomes assessments will also be conducted.~   "
260125|NCT00144859|"~     This is a 28-day, placebo controlled clinical study assessing the safety, tolerability~     anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic~     Obstructive Pulmonary Disease).~   "
260126|NCT00144846|"~     This study evaluates the effect of cumulative dose administration of albuterol sulfate~     inhalation aerosol delivered with valved holding chamber and facemask. This is a four week~     study in birth to 23 month old subjects who are experiencing acute wheezing due to~     obstructive airways disease.~   "
260127|NCT00144833|"~     For HIV-infected individuals with highly resistant viruses, higher drug levels may be~     required to block the virus. This study investigates that concept by comparing the efficacy~     of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a~     combination of fosamprenavir (increased dose)/lopinavir/ritonavir.~   "
260128|NCT00144820|"~     251 consecutive patients with knee arthrosis were randomized to one of three interventions:~     Four weekly injections of 2 ml isotonic saline (placebo), 2 ml sodium hyaluronate~     (hyaluronan) or 20 ml isotonic saline (excessive saline).~      They all suffered from clinically and radiologically verified arthrosis of the knee with~     daily pain that did not respond to treatment with analgetics.~      Results were evaluated at weeks 1,2,3,4,8,12,16 and 26. Biochemical markers for bone and~     cartilage degradation were measured in urine/blood.~   "
260129|NCT00144807|"~     This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to~     59 years with high risk diffuse large B-cell lymphoma~   "
260130|NCT00144794|"~     The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that~     tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will~     provide information to better characterize the natural history and progression of MPS I as~     well as the clinical responses of patients receiving enzyme replacement therapy, such as~     Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities.~      The objectives of the Registry are:~        -  To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase)~        -  To characterize and describe the MPS I population as a whole, including the variability,~          progression, and natural history of MPS I~        -  To help the MPS I medical community with the development of recommendations for~          monitoring patients and reports on patient outcomes to optimize patient care~   "
260131|NCT00144781|"~     The main purpose of this study is to evaluate differences in the pharmacodynamic response of~     4 Aldurazyme® (laronidase) dose regimens in patients with Mucopolysaccharidosis I (MPS I).~   "
260132|NCT00144768|"~     The purpose of this study is to determine whether the development of antibodies to laronidase~     in patients with MPS I receiving Aldurazyme® impairs the clearance of GAG substrate.~   "
260133|NCT00144755|"~     This study is a multicentric randomized trial evaluating the efficacy and safety of R-CHOP~     given every 14 days compared to R-CHOP given every 21 days in association or not with~     darbepoetin alfa in order to maintain hemoglobin above 13 g/dl, compared to classical~     symptomatic treatment of anemia in patients aged from 60 to 80 years with diffuse large~     B-cell lymphoma.~   "
260134|NCT00144729|"~     A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan~     (4 x 50 mg/kg) plus ATG (3 x 30 mg/kg) and the TBI dose starting at 3 x 200 cGy is escalated~     or de-escalated dependent upon engraftment and toxicity.~   "
260135|NCT00144716|"~     Insecticide Treated Nets (ITN's) offer good protection against malaria in Africa where the~     vector mosquitoes feed indoors late at night. However, in other parts of the world like South~     America, vectors feed earlier in the evening before people go to bed. In such cases it may be~     necessary to use alternative treatments in the evening to supplement the efficacy of ITN's.~     This study compares 2 matched groups of households in the Bolivian Amazon. One group will be~     given ITN's plus a plant-based insect repellent in the evening, the other has ITN's plus a~     placebo lotion. Households are monitored over a full malaria season to record numbers of~     malaria cases.~   "
260136|NCT00144703|"~     The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus~     host disease (GVHD) in patients following stem cell transplant from a related donor.~   "
260137|NCT00144690|"~     The primary objective of this study is to determine the maximal tolerated dose (MTD) of E2007~     given twice daily (bid) or once a day (qd) in patients with refractory partial-onset seizures~     (including secondarily generalized seizures). The secondary objectives are to evaluate the~     safety, efficacy, concentration-efficacy relationship, and pharmacokinetics of E2007 and the~     effects of E2007 on the Profile of Mood States (POMS) test.~   "
260138|NCT00144677|"~     The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus~     host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This~     trial is designed to test the hypothesis that elimination of methotrexate in the unrelated~     donor group would lead to less transplant-related toxicity while still preserving the~     effective control of GVHD.~   "
260139|NCT00144664|"~     This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in~     patients with pJIA.~   "
260140|NCT00144651|"~     This is an open-label, extension, Phase II study to evaluate the long-term safety and~     efficacy of MRA in Patients with RA who were participated in Study MRA009JP.~   "
260150|NCT00144521|"~     The purpose of this study is to investigate the clinical efficacy and safety of MRA in a~     double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid~     arthritis (RA) patients with MTX administered.~   "
260151|NCT00144508|"~     To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to~     receive either MRA or conventional DMARDs.~   "
260152|NCT00144495|"~     The purpose of this study is to evaluate the effectiveness and safety of recombinant human~     erythropoietin in anemic cancer patients undergoing chemotherapy.~   "
260153|NCT00144482|"~     To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in~     anemic cancer patients undergoing chemotherapy~   "
260154|NCT00144469|"~     This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus~     ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with~     peginterferon alfa-2a monotherapy.~      Additionally, the study evaluated the efficacy and safety of the combination of peginterferon~     alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous~     conventional-interferon based therapy.~   "
260155|NCT00144456|"~     A prospective, randomized, double-blind study to compare the effect of ED-71 with that of~     alfacalcidol on fracture incidence~   "
260156|NCT00144443|"~     Objective: Our overall objective is to test the hypothesis that the health of children with~     chronic respiratory symptoms or chronic exposures to environmental hazards can be improved~     through a combination of standard home maintenance interventions and a set of interim~     controls and targeted repair interventions.~      I. Background:~      The Bi-State Kansas City Enhanced Enterprise Community (KCEEC) is one of pervasive poverty,~     unemployment and general distress. This same area is also an area of poor environmental~     health with a disproportionate number of children with lead poisoning, asthma, and home~     injuries.~      In May 2001, the Metropolitan (Kansas City) Health Council released a report urging the~     implementation of strategies to address this growing concern. They stated, “Environmental~     assessments and interventions in homes, schools, and workplaces are needed to promote indoor~     air quality and thereby help prevent asthma and asthma flare-ups,” in combination with the~     need for, “trained community-based peer educators needed to work with families/communities in~     areas of high asthma incidence,”. The need for major rehabilitation is echoed in the 1999~     Consolidated Plan, as well as by most community development and housing officials.~      The KC CERT project responds to these concerns by demonstrating low-cost, replicable~     intervention strategies that can have an impact on the health and safety of children and~     their families. By providing training and employment opportunities to residents in high-risk~     areas to assess, prevent and remediate environmental hazards, this project promotes sustained~     systematic change within the KCEEC.~   "
260157|NCT00144430|"~     This is a multicenter trial through the Pediatric Blood and Marrow Transplant Consortium.~      The Primary hypothesis of this study is that because of its effect as a potent~     immunosuppressive agent targeting lymphocytes, pentostatin will show a sustained response in~     pediatric subjects with severe chronic GVHD. Secondary hypotheses include that the infection~     and toxicity rate of pentostatin in this setting will be acceptable given its lack of severe~     myelosuppression, and subjects with refractory chronic GVHD will have significant QOL~     impairment and symptomatology. These may change as subjects are being treated for their~     chronic GVHD with pentostatin.~   "
260158|NCT00144417|"~     This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in~     daily treatment during the first two months of treatment with rifampin, pyrazinamide and~     ethambutol for sputum smear-positive pulmonary tuberculosis.~   "
260159|NCT00144404|"~     The purpose of this study is to determine the blood levels of testosterone gel administered~     for a week to women with hypopituitarism and determine if this leads to testosterone~     replacement in a normal range for women. An additional objective is to determine the baseline~     laboratory abnormalities and physical, brain function, emotional and sexual symptomatology of~     these women with hypopituitarism.~   "
260160|NCT00144391|"~     The principal aim of this study is to evaluate if application of testosterone gel leads to~     improvement in measures of sexual function, thinking ability and quality of life in women~     with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of~     testosterone replacement on body composition and muscle function and strength.~   "
260161|NCT00144378|"~     The median survival at progression after first-line chemotherapy for metastatic gastric~     cancer is about 2.5 months. There are no data which a possible benefit of second line~     therapy. for this reason a trial which investigates a possible benefit or chemotherapy~     compared to best supportive care as second line treatment is urgently necessary.~      Irinotecan shows response rates of 20% in the first line therapy with high rates od disease~     stabilization. There are few trials investigating irinotecan in the second line setting.~     Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from~     the company Pfizer.~   "
260162|NCT00144365|"~     The study is a 3-year, randomized trial to compare ART delivery through two different models:~     a) ART delivered through health facilities by clinically qualified staff and b) home-based~     care in which lay workers, i.e. non-medically qualified people, play a major role in the ART~     delivery and clients are followed up at health facilities less frequently. The primary~     objective is to measure the effects of these strategies on HIV viral load. We will also~     examine the effects on treatment failure, disease progression, survival, adherence, family~     member HIV testing, sexual behavior, and cost-effectiveness.~   "
260180|NCT00144131|"~     This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®)~     extended dose schedule administration (EDS) versus darbepoetin alfa administered once per~     week (QW) in the treatment of anemia in subjects with non-myeloid malignancies receiving~     multi-cycle chemotherapy.~   "
260181|NCT00144118|"~     The purpose of this study is to determine if isoflurane and sevoflurane have similar effects~     on the kidneys of people with impaired kidneys when the drugs administered with low gas flow~     into anaesthetic machines.~   "
260182|NCT00144105|"~     Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an~     active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected~     patients~   "
260183|NCT00144092|"~     Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem~     cell transplanation.~   "
260163|NCT00144352|"~     Plasmodium falciparum malaria and HIV are among the most important infectious diseases in~     sub-Saharan Africa. Approximately two-thirds of the estimated 35 million HIV infected persons~     live in sub-Saharan Africa. Of the 300-500 million annual cases of malaria infection~     occurring worldwide, about 90% of P. falciparum infections occur in sub-Saharan Africa,~     resulting in approximately 1 million deaths, mostly in children under five years of age. It~     is clear that HIV and malaria are responsible for substantial disease, suffering, and an~     enormous economic burden on the people who can least afford it. Although a study in 1993 in~     Tanzania showed significantly higher prevalence of malaria infections in HIV-positive~     compared to HIV negative adults, until recently there have been few studies showing any~     association between the two infections.~      We conducted a study to measure the efficacy of the then-first line antimalarial drug~     (sulfadoxine-pyrimethamine) among patients in three study arms: those who were HIV negative,~     those who were HIV infected with CD4 cell counts < 200, and among HIV infected patients with~     CD4 cell counts >= 200. Our hypothesis is that patients with HIV infection and low CD4 cell~     count will not respond to antimalarial therapy as well as patients who are HIV infected with~     higher CD4 cell counts or who are HIV negative.~   "
260164|NCT00144339|"~     The primary objective of this trial is to determine whether daily treatment with tiotropium~     (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of~     decline in lung function over time in patients with COPD.~   "
260165|NCT00144326|"~     The objective of this study is to determine if tiotropium (Spiriva, Bromuro de Tiotropio) 18~     mcg once daily by oral inhalation compared to placebo increases the magnitude of daily~     physical activity observed in COPD patients, measured using an accelerometer.~   "
260166|NCT00144313|"~     The purpose of this study is to determine immune status of adolescents who responded to a~     primary series of recombinant hepatitis B vaccine given at birth and to assess their response~     to a booster dose of vaccine.~   "
260167|NCT00144300|"~     To determine if there is any difference in the presence of retinal deterioration in PD~     patients treated with pramipexole IR versus ropinirole as monitored by comprehensive~     ophthalmologic assessments from baseline to the end of study at two years.~   "
260168|NCT00144287|"~     This study evaluated the safety and tolerability of tipranavir to improve treatment options~     for HIV type 1-infected patients who have been previously treated and whose treatment is no~     longer effective.~   "
260169|NCT00144274|"~     The purpose of this trial is to investigate efficacy and tolerability of lozenges containing~     20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in~     adolescent patients suf fering from acute viral pharyngitis. The primary endpoint is the~     time-weighted average of the pain intensity difference from pre-dose bas eline over the first~     3 hours after the first lozenge expressed as a ratio of the pre-dose baseline ( SPIDnorm).~   "
260170|NCT00144261|"~     1. In order to obtain further insight as to how NVP affects HDL metabolism, the in vivo~          kinetics of the HDL apolipoprotein, Apo A-1, before and 6 weeks after initiation of NVP~          containing treatment were evaluated. In addition, the activity of the key enzymes~          related to HDL metabolism were assessed.~           [ Designated as safety issue: No ]~        2. In order to determine the relevance of the HDL increase in decreasing cardiovascular~          risk in HIV-positive subjects we evaluated endothelial function (FMD) as a surrogate~          marker for cardiovascular disease in patients.~      [ Designated as safety issue: No ]~   "
260171|NCT00144248|"~     The objective of this study was to evaluate the steady-state clearance of nevirapine among~     HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic~     impairment influences clearance.~   "
260172|NCT00144235|"~     To assess the efficacy and safety of Pharmaton? PHL 00749 in improving cognitive function and~     allevi ating mental and physical stress in healthy male and female subjects leading demanding~     lifestyles.~   "
260173|NCT00144222|"~     The objective of this trial is to demonstrate that the fixed dose combination of telmisartan~     40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis, Gliosartan,~     Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) 40 mg in patients with essential~     hypertension who fail to respond adequately to telmisartan monotherapy.~   "
260174|NCT00144209|"~     The primary objective of this study is to determine that pramipexole (Sifrol) 0.25 mg to 0.75~     mg daily is not inferior to levodopa 100 mg to 300 mg (in combination with benserazide 25mg~     to 75mg = Madopar DR) daily in the treatment of patients with idiopathic restless legs~     syndrome fulfilling the International Diagnostic Criteria. The efficacy parameters include an~     objective measure of the leg movements during the time spent in bed, and a quantitative~     clinical assessment of the severity of RLS, in the form of the RLS-score. In addition, the~     efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome~     measures such as quality of life and sleep.~   "
260175|NCT00144196|"~     To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler®~     improves lung function in patients with mild COPD according to Swedish guidelines.~   "
260176|NCT00144183|"~     To determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of~     Combivir®, compared to a regimen of single dose nevirapine, for the prevention of mother to~     child transmission can reduce the rate of development of drug resistant mutations of HIV-1,~     in HIV-1 infected pregnant women, who have not received antiretroviral therapy previously.~   "
260177|NCT00144170|"~     The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir~     versus an active control arm in highly treatment experienced Human immunodeficiency virus-1~     infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating~     at least one resistance conferring protease inhibitor-mutation as determined from a~     predefined panel of mutations. Any CD4+ count is acceptable.~   "
260178|NCT00144157|"~     To determine the response to treatment with NVP, ZDV and 3TC in HIV positive women, who~     previously received NVP for the prevention of mother to child transmission.~   "
260179|NCT00144144|"~     The antihypertensive effect of the increased dose of angiotensin II receptor blocker (AII~     antagonist) is compared with that of the additional combined use of amlodipine in~     hypertensive patients with Type 2 diabetes mellitus, who have been treated with AII~     antagonist, the antihypertensive effect of which has been inadequate.~   "
263635|NCT00097799|"~     This study was designed to provide early access to and evaluate the safety of TPV/r in~     PI-experienced patients with HIV-1 infection.~   "
260184|NCT00144079|"~     The trial examines the clinical benefit of adjuvant external beam radiotherapy (RTx) for~     locally invasive differentiated carcinoma (TNM stages pT4 pN0/1/x M0/x; 5th ed. 1997) of the~     thyroid gland (DTC). Patients are treated with surgery (thyroidectomy and lymphadenectomy),~     radioiodine therapy (RIT) to ablate the thyroid remnant tissue, and TSH-suppressive~     L-thyroxine therapy with or without RTx after documented elimination of cervical I-131~     uptake.~   "
260185|NCT00144066|"~     A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based~     chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV~     NSCLC.~   "
260186|NCT00144053|"~     To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over~     concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable~     stage III NSCLC.~   "
260187|NCT00144040|"~     Purpose The emergence and rapid rise in antibiotic resistance among common bacteria are~     adversely affecting the clinical course and health care costs of community-acquired~     infections. Because antibiotic resistance rates are strongly correlated with antibiotic use~     patterns, multiple organizations have declared reductions in unnecessary antibiotic use to be~     critical components of efforts to combat antibiotic resistance. Among humans, the vast~     majority of unnecessary antibiotic prescriptions are used to treat acute respiratory tract~     infections (ARIs) that have a viral etiology. Although the rate of antibiotic prescribing for~     ARIs by office-based physicians in the US has decreased about 16% from its peak in 1997, the~     rate of antibiotic prescribing in acute care settings (eg, emergency departments and urgent~     care centers), which account for 1 in 5 ambulatory antibiotic prescriptions in the US, has~     shown only a modest decline (6%) during this period. Translation of lessons from intervention~     studies in office-based practices is needed to improve antibiotic use in acute care settings.~   "
260188|NCT00144027|"~     Efficacious antipsychotic medication treatments for schizophrenia are available; however ,~     antipsychotic regimens frequently do not achieve their potential because of poor medication~     adherence. To date, medication adherence interventions have not been widely adopted or~     sustained in real-world practice settings. One reason for this is the substantial resource~     investment necessary to implement and sustain available interventions. In response to these~     problems, we developed a patient-centered adherence intervention based on patient-identified~     barriers, facilitators, and motivators (BFMs) for medication adherence. The intervention~     includes a BFM survey (checklist and preference weighting exercise to determine the patient's~     most important BFM) and a brief list of adherence enhancing suggestions (Options List)~     tailored to the patient-identified BFMs and compatible with CPRS. The long-term objective of~     this proposed research is to improve antipsychotic medication adherence and clinical outcomes~     for patients with schizophrenia using a cost-effective medication adherence intervention. The~     short-term objectives are to refine and test a patient-centered medication adherence~     intervention for VA patients with schizophrenia and specifically to: 1. Enhance the~     feasibility and acceptability of the BFM intervention by reducing the burden on patients and~     mental health providers through BFM checklist item reduction, provider intervention input,~     and patient intervention input. We hypothesize that our use of end-user input will result in~     at least 80% of intervention patients having documentation of a BFM intervention in CPRS. 2.~     Compare the effects of the BFM intervention versus usual care on changes in medication~     adherence and schizophrenia symptom severity. We hypothesize that the intervention will~     result in a) greater medication adherence and b) lower schizophrenia symptom severity than~     usual care. 3. Exploratory objective: compare the effects of the BFM intervention versus~     usual care on changes in patient health-related quality of life. We hypothesize that the~     intervention will result in greater health-related quality of life than usual care.~   "
260189|NCT00144014|"~     A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in~     acute ischaemic stroke~   "
260190|NCT00144001|"~     Nearly 2% of veterans >65 are actively treated for epilepsy, and the incidence is projected~     to increase with the aging of our society. Since commonly used antiepileptic drugs are~     considered suboptimal for older patients, it is important to understand existing patterns of~     treatment for older veterans with epilepsy.~   "
260191|NCT00143988|"~     The purpose of this study is to determine the amount of cardiac work as measured by heart~     rate and blood pressure during physical exertion compared to sexual activity.~   "
260192|NCT00143975|"~     GO-A-HAM:~      Gemtuzumab Ozogamicin 3g/m² day 1 Cytarabine 3g/m² bid days 1-3 Mitoxantrone 12mg/m² days 2,3~     All-trans Retinoic acid 45mg/m² days 4-6 and 15 mg/m² days 7-28~   "
260193|NCT00143962|"~     This is a follow-up research study to determine if there are any differences in the long-term~     maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program~     (low-fat). The Atkins' diet continues to get a significant amount of popular attention and~     very little scientific evaluation. Due to the small amount of scientific data to support a~     low-carbohydrate diet and given the wide spread use of this type of diet, it is important to~     evaluate the long-term safety and effectiveness of the Atkins' diet.~      We will evaluate whether there are any differences between these two groups 3-years after~     participation in the initial 1-year study period. We will specifically assess weight,~     cholesterol levels, glucose and insulin levels, and eating habits and mood as we did~     originally.~   "
260194|NCT00143949|"~     To determine if renin angiotensin medications can prevent or delay the onset of diabetic~     kidney disease.~   "
260195|NCT00143936|"~     This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet)~     with a high carbohydrate diet (conventional USDA diet).~   "
260196|NCT00143923|"~     This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to~     identify high-risk populations, (2) identify disparities in cardiovascular risk based on~     race, socioeconomic status, and geographic location, (3) evaluate mechanisms for population~     differences in cardiovascular risk, and (4) implement a multidisciplinary community-based~     intervention program to decrease cardiovascular risk in high-risk populations. These goals,~     which are designed to eliminate ethnic and racial health disparities, are closely tied to the~     National Initiative to Eliminate Racial and Ethnic Disparities in Health and the nation's~     health promotion and disease prevention agenda established in Healthy People 2010.~      This is a prospective cohort study of 2,000 residents of the state of Pennsylvania with~     approximately equal representation of white and African American subjects. All participants~     will undergo assessments of traditional and nontraditional risk factors to identify and~     determine the mechanisms of population disparities in cardiovascular risk. 800 participants~     who are at intermediate or high risk of cardiovascular disease will be randomly assigned to~     either (1) usual care/advice only; or (2) a multidisciplinary behavioral modification~     program to determine the most effective approach to reduce or eliminate racial, socioeconomic~     and geographic disparities in cardiovascular risk. All participants will undergo long-term~     follow-up for cardiovascular events.~   "
260197|NCT00143910|"~     This study began in 1993 as a prospective, natural history study of renal transplant~     patients' medication compliance measured by using an electronic monitor on the cap of~     medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes.~     Enrollment is closed.~   "
260198|NCT00143884|"~     This research project will focus on whether it is safe and effective to rely on donor cells~     to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell~     transplant.~   "
260199|NCT00143871|"~     This study is being conducted to determine the safety, side effects, and response to a~     combination of an established high-dose chemotherapy regimen, plus the addition of Rituximab~     (which is a form of immunotherapy).~   "
260200|NCT00143858|"~     The purpose of this study is to determine the clinical usefulness of measuring the heart's~     pumping ability by measuring the Peripheral Pulse Volume (PPV).~   "
260201|NCT00143845|"~     The purpose of this study is to determine whether a reduced intensity conditioning regimen~     for stem cell transplant with donor cells will allow the donor cells to be effective without~     causing health problems.~   "
260202|NCT00143832|"~     Poor inhibitory control has been proposed to be central to the cognitive deficits and~     symptomatology associated with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a~     highly heritable disorder with an increased incidence among the siblings of affected~     individuals. In the current proposal we investigate the expression of genetic susceptibility~     for ADHD in brain functioning. We will study cognitive functioning in patients with ADHD,~     their unaffected siblings and healthy matched controls. Our aims are 1) to determine whether~     increased familial risk for ADHD is associated with differential patterns of brain activation~     compared to normally developing children, during the performance of tasks designed to probe~     cognitive functions that are compromised in ADHD and 2) to determine whether differential~     patterns of activation are similar for boys with ADHD and their unaffected siblings.~   "
260203|NCT00143819|"~     The purpose of this study is to assess the efficacy of Neuroskin Forte in relieving the~     symptoms of dry skin in adults with psoriasis or eczema.~   "
260204|NCT00143806|"~     The purpose of this study is to devise a safe and effective method for transitioning patients~     from cyclosporine to alefacept.~   "
260205|NCT00143793|"~     The objectives of this study are to:~        -  Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain~          natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure~          in patients with acute dyspnea and/or edema.~        -  Determine the exact biomarker cut-off point(s) for the differentiation of healthy~          persons, patients with heart failure and patients with dyspnea of other origin.~        -  Evaluate treatment costs in patients with dyspnea under special consideration of~          NT-proBNP measurement.~   "
260206|NCT00143780|"~     Streptococcus pneumoniae, also known as Pneumococcus, is a common cause of pneumonia in~     transplant patients. There has been a vaccine available for this infection called Pneumovax.~     Recently, a new vaccine for this infection called Prevnar has been developed which may be~     more effective. Vaccinating the bone marrow donor before transplant may boost the recipient's~     immune response to the vaccine after transplant. This study is done to compare how~     vaccinating the donor with one of the vaccines will affect the recipient's immune system~     response to the vaccine.~   "
260207|NCT00143767|"~     The primary purpose of this study is to investigate brain whether ADHD represents a~     disruption or a delay of brain development. Children and adolescents both with and without~     ADHD are asked to participate in several MRI sessions, two years apart. This will allow us to~     chart brain development over time, both in typical development and ADHD, and therefore to~     address whether ADHD represents a disruption or a delay of typical brain development.~   "
260208|NCT00143754|"~     Beneficial effect of chronic hydration with salt supplementation in patients with recurrent~     unexplained syncope is not established. We sought to determine if chronic oral rehydration~     with salt supplementation improved the tolerance and hemodynamic responses of patients with~     unexplained recurrent syncope.~   "
260209|NCT00143741|"~     The purpose of this study is to identify subjects who are highly sensitized with antibodies.~     It is difficult for these patients to find suitable kidneys. We propose to treat such~     patients to decrease the antibodies in such a way, that it may become possible to safely~     transplant kidneys into them.~   "
260210|NCT00143728|"~     The purpose of this study is to compare the effects of continuing or discontinuing 3TC~     treatment in the presence of HIV virus with 3TC resistance for persons who are on a regimen~     including least three other anti-HIV drugs. The overall aim is to determine whether~     continuing 3TC is of benefit in HIV-positive persons who have already shown resistance to~     this drug.~   "
260211|NCT00143715|"~     Excessive prolongation of the international normalized ratio (INR) occurs frequently in~     patients taking warfarin; in fact, about one in six INR values is above the desired range.~     Excessive prolongation of the INR is clinically important because the risk of bleeding~     approximately doubles for each one point increase in the INR beyond the usual therapeutic~     range. Thus, treatment strategies which rapidly and reliably lower an excessively prolonged~     INR into the desired range have the potential to reduce bleeding. When taken by patients with~     INR values between 4.5 and 10, a small dose of oral vitamin K (1 mg to 2.5mg) reduces the INR~     into the desired INR range in about 75% of cases within 24 hours of its administration. If~     warfarin is simply withheld, and no vitamin K is given, about 25% of patients will have an~     INR in the desired range at 24 hours. However, vitamin K is rarely given to such patients. In~     a recent survey carried out by our group, less than 20% of such patients would have been~     given low dose oral vitamin K by a group of physicians who regularly supervise warfarin~     therapy.~      The most common treatment for excessive prolongation of the INR is to simply withhold~     warfarin and allow the INR to fall into the therapeutic range. Although this strategy is~     effective its safety has never been adequately examined. In fact, recent evidence suggests~     that patients with INR values of more than 6.0 who are treated with simple warfarin~     withdrawal have a risk of major bleeding of 4% in the two weeks after they develop their~     prolonged INR.~      When asked why they did not give oral vitamin K to a non-bleeding patient who has an~     excessively prolonged INR, physicians generally give one of three reasons: (1)They are not~     convinced that oral vitamin K reduces bleeding. (2) They are concerned that oral vitamin K~     may cause thrombosis. (3) In contrast with simply withholding warfarin, giving oral vitamin K~     requires a patient to visit the physician, and the physician must have a supply of vitamin K.~      The investigators hypothesize that the routine practice of not administering oral vitamin K~     to patients with excessively prolonged INR values is causing patients to have major,~     life-threatening and fatal bleeds. To convince physicians that oral vitamin K should be~     administered to all non-bleeding patients with INR values of more than 4.5, the investigators~     propose a study which the investigators anticipate will demonstrate that oral vitamin K~     reduces bleeding, does not cause thrombosis, and can be administered at home without direct~     physician supervision.~      To accomplish these goals, the investigators propose a multinational, double-blind,~     placebo-controlled trial. The investigators will randomize patients with INR values between~     4.5 and 10.0 to receive 1.25 mg of oral vitamin K or placebo and follow them for bleeding and~     thrombosis. Patients with INR values of more than 10.0 will receive a single 1.25 mg dose of~     oral vitamin K.~      Successful completion of this study will establish a treatment standard supported by clinical~     data which will, in turn, change the way that patients taking warfarin who present with an~     excessively prolonged INR are treated.~   "
260248|NCT00143234|"~     The purpose of the study is to measure the effect of the amlodipine/atorvastatin combination~     pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by~     guidelines~   "
260249|NCT00143221|"~     The purpose of this study is to determine whether Viagra is effective in treating erectile~     dysfunction and lower urinary tract symptoms in men affected by both conditions.~   "
260212|NCT00143702|"~     The purpose of this study is to determine the best way to treat people on d4T (stavudine)~     with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding~     riboflavin and thiamine will also be assessed.~      Participants will be randomly assigned to one of four groups:~        -  Group 1 participants will continue to take d4T as part of their antiretroviral (ARV)~          regimen, and will be given the vitamin supplements~        -  Group 2 will continue to take d4T without vitamin supplements~        -  Group 3 will switch from d4T to abacavir and receive the vitamins~        -  Group 4 will switch from d4T to abacavir without vitamin supplements.~      The study plans to involve eighty participants from Canada and Argentina for a treatment~     period of 16 weeks and a follow-up visit at week 24.~   "
260213|NCT00143689|"~     This study will compare a nucleoside reverse transcriptase inhibitor-sparing (NRTI-sparing)~     regimen (Kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based~     regimens (Combivir + nevirapine and Combivir + Kaletra).~      Participants will be randomly assigned to receive one of the following drug combinations:~        -  lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;~        -  Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;~        -  Combivir and lopinavir/ritonavir twice a day.~   "
260214|NCT00143676|"~     The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily~     (QD), on lowering cholesterol in subjects already taking atorvastatin.~   "
260215|NCT00143663|"~     The purpose of this study is to determine if patients with elevated cholesterol, but not~     taking any other lipid medication, could lower their cholesterol with administration of~     lapaquistat acetate, once daily (QD).~   "
260216|NCT00143650|"~     The study is focussed on two main questions:~        1. The importance of dampness of the building and home dust as a factor of the subjects=~          responses.~        2. Can measures used in KLINIR predict the subjects’ responses to the dust?~      This study therefore was arranged to test the following hypotheses:~        1. Does dust in general cause inflammatory/body perceptions through e.g. an irritation~          symptoms index.~        2. Does the dust include effective odorants which affects an IAQ index?~        3. Does dampness increase the content of organic or inorganic compounds e.g. of microbial~          origin that causes the dust to be more reactive? (Differences between the two types of~          dust)~        4. Is the sensitivity of the subjects explaining the responses to exposures in a, b, or c?~          (Subject group and sensitivity index)~      As explorative investigations biomarkers for exposures and sensitivity for practical usage~     are tested.~   "
260217|NCT00143637|"~     The study is focused at the dose response relation for office dust and such office dust~     spiked with components from fungi known from damp buildings.~      The first aim of this study is to investigate if dust causes objective changes such as~     changes of lung function, nasal geometry, inflammatory indicators in tears and nasal lavage,~     tear film stability and cells at exposure levels relevant to indoor air. The controlled~     exposure variable is air concentration of office dust spiked with Glucan to simulate a worse~     case scenario.~      Aim 1: Confirm or support the causality between objective effects and exposures to dust~     spiked with Glucan with focus on inflammatory responses. This is done by negation of the~     hypothesis that no significant effects are found for the variables in question.~      Aim 2 is to estimate the thresholds and slopes of the DR relation for effect measures which~     show effects of exposures. At best the study will supply for each variable a zero response to~     clean air and three non-zero responses to dust. Thresholds and slopes are estimated~     graphically by linear regression or by an accumulated response model.~      Aim 3 is a confirmation that atopic persons and histamine sensitive persons in nasal~     provocation tests have different responses in the effect measures showing significant effects~     of exposures to dust spiked with Glucan. Risk group status is therefore included in the~     analyses of the main variables as explaining variable.~      Potential additional aim 4: Chemical and biological characterization of the office dust used~     in the study.~      Aim 4 is an investigation of dose response relations for explorative measures, which in~     previous investigations have showed indications of a dose response relation. For these no a~     priory hypotheses exists and the analyses must be arranged ad hoc. The explaining variables~     are exposure and risk group status.~      One challenge in investigations of unspecific effects caused by mixed exposures is that few~     specific objective effects measures are available and subjective measures have to be~     introduced. Therefore there is a need for developments of new objective measures of health~     effects of air pollution. Some of these are related to new biomarkers of respiratory effects~     in a bio-sample taken as condensed exhaled breath.~      Aim 5: Developments of new objective measures of health effects of air pollution. After the~     experiment it will be investigated by logistic regression if a sensitivity index can be~     established.~   "
260218|NCT00143624|"~     This trial will study the effect of rosiglitazone on the progression of atherosclerosis~     (hardening of blood vessels) through improvements of the sugar and fat metabolism (body~     buildup, breakdown and excretion of sugar and fat).~      Participants will be randomly assigned to one of two groups: the first group will receive 8~     mg of the study drug and the second group will be given a placebo, though neither group will~     know which formulation they are receiving. The study will follow both groups for one year,~     during which it will measure changes in blood vessel composition and activity, sugar~     metabolism, concentration of blood fat, and body fat distribution. This single-site study~     aims to enroll 50 participants.~   "
260219|NCT00143611|"~     The purpose of this study is to determine the optimal dose of Resatorvid for reducing 28-day~     all-cause mortality in subjects with severe sepsis.~   "
260220|NCT00143598|"~     The purpose of this study is to determine whether elastic compression stockings used for 2~     years are effective in preventing the post-thrombotic syndrome in patients with symptomatic~     proximal deep venous thrombosis.~   "
260221|NCT00143585|"~     To demonstrate the clinical efficacy and safety of vascular endothelial growth~     factor(VEGF165)when delivered by direct myocardial injection through the NOGA navigational~     catheter to improve myocardial perfusion in patients with severe angina pectoris for whom~     conventional PCI or CABG are either not possible or not ideal.Secondary objective will be to~     determine the effects of VEGF gene therapy on angina symptoms, patient perceived quality of~     life and exercise capacity~   "
260222|NCT00143572|"~     The purpose of this study is to estimate the MTD of Mg pidolate in combination with HU in~     patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU~     for at least 6 months.~   "
260250|NCT00143208|"~     This study is designed as an open label evaluation of the efficacy of latanoprost and timolol~     fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at~     the baseline visit. All current ocular hypotensive therapy must be discontinued at this time.~     On baseline day, patients eligible for the study will receive Xalacom which is to be~     instilled in the morning.~   "
260251|NCT00143195|"~     The objective of study is to compare the anti-ischemic efficacy and safety profiles of once~     daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and~     symptomatic myocardial ischemia~   "
260266|NCT00143000|"~     The primary objective of the study is to demonstrate that the efficacy of peginterferon~     alfa-2a 40KD combination therapy with ribavirin in interferon naïve patients with chronic~     hepatitis C virus infection genotype 2 or 3 given for 12 weeks is non-inferior to 24 weeks.~   "
260223|NCT00143559|"~     Blood and marrow stem cell transplant has improved the outcome for patients with high-risk~     hematologic malignancies. However, most patients do not have an appropriate HLA (immune type)~     matched sibling donor available and/or are unable to identify an acceptable unrelated HLA~     matched donor through the registries in a timely manner. Another option is haploidentical~     transplant using a partially matched family member donor.~      Although haploidentical transplant has proven curative in many patients, this procedure has~     been hindered by significant complications, primarily regimen-related toxicity including GVHD~     and infection due to delayed immune reconstitution. These can, in part, be due to certain~     white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize~     the body tissues of the patient (the host) are different and attack these cells. Although too~     many T cells increase the possibility of GVHD, too few may cause the recipient's immune~     system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk~     for significant infection.~      For these reasons, a primary focus for researchers is to engineer the graft to provide a T~     cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to~     facilitate immune reconstitution and graft integrity. Building on prior institutional trials,~     this study will provide patients with a haploidentical graft engineered to specific T cell~     target values using the CliniMACS system. A reduced intensity, preparative regimen will be~     used in an effort to reduce regimen-related toxicity and mortality.~      Two groups of patients were enrolled on this study. One group included those with high-risk~     hematologic malignancies and the second group included participants with refractory~     hematologic malignancies or undergoing a second transplant. The primary aim of the study was~     to estimate the relapse rate in the one group of research participants with refractory~     hematologic malignancies or those undergoing second allogeneic transplant. Both groups will~     be followed and analyzed separately in regards to the secondary objectives.~      This study was closed to accrual on April 2006 as it met the specific safety stopping rules~     regarding occurrence of severe graft vs. host disease. Although this study is no longer open~     to accrual, the treated participants continue to be followed as directed by the protocol.~   "
260224|NCT00143546|"~     Veno-occlusive disease (VOD) of the liver is a significant complication for some patients~     undergoing hematopoietic stem cell transplantation. This disease is thought to be a toxicity~     secondary to chemotherapy or radiation-induced damage to the epithelial cells of the blood~     vessels in the liver. VOD is categorized as mild, moderate or severe. Historically, there has~     been no method to treat the disease. Recently, however, there have been investigations into~     the use of a new agent called defibrotide.~      The primary purpose of this protocol is to provide defibrotide to patients with severe VOD.~     Because this drug has not been approved by the FDA, use of this medication under the auspices~     of this IND treatment plan is for compassionate use only.~   "
260225|NCT00143533|"~     The primary purpose of this study is to estimate the maximum tolerated dose of irinotecan~     with the use of cefpodoxime for pediatric solid tumor patients.~   "
260226|NCT00143520|"~     This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin~     sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not~     adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a~     placebo and active treatment group for comparison.~   "
260227|NCT00143507|"~     The aim of this study is to test whether ivabradine is able to reduce cardiovascular events~     when given to patients with coronary artery disease and impaired heart function.~   "
260228|NCT00143494|"~     The investigators aim to compare the bladder pressure to the gastric pressure in critically~     ill patients.~   "
260229|NCT00143481|"~     The purpose of the study is to assess the impact of treatment with tolterodine ER versus~     placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.~   "
260230|NCT00143468|"~     The investigators aim to study the specific elastance in ALI/ARDS patients during invasive~     mechanical ventilation.~   "
260231|NCT00143455|"~     To compare the effects of irinotecan hydrochloride with cisplatin to the standard regimen~     etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly~     diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).~   "
260232|NCT00143442|"~     The purpose of this study is to determine the effectiveness of [S,S]-Reboxetine in the~     treatment of chronic pain following a shingles infection in patients who are Gabapentin~     treatment failures.~   "
260233|NCT00143429|"~     Compare the antihypertensive efficacy of three methods for installing Xalatan~   "
260234|NCT00143416|"~     Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients~     with acromegaly.~   "
260235|NCT00143403|"~     To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver~     metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen,~     compared to 5-FU/FA alone.~   "
260236|NCT00143390|"~     To verify the non-inferiority of exemestane compared to anastrozole in time to tumor~     progression (TTP), the primary efficacy endpoint, in postmenopausal women with~     advanced/recurrent breast cancer.~   "
260237|NCT00143377|"~     The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine~     tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive bladder~     and which of these bothersome symptoms are improved with treatment.~   "
260238|NCT00143364|"~     The primary purpose of this study is to evaluate the safety and efficacy of varenicline given~     for a twelve week treatment period in comparison with placebo and Zyban for smoking~     cessation.~   "
260239|NCT00143351|"~     To assess the long-term efficacy of oral Ziprasidone in the maintenance treatment of~     resistant schizophrenic subjects who have benefited from participation in the phase III~     ziprasidone study A1281039 (MOZART study), to assess the efficacy of ziprasidone in the~     relapse prevention of schizophrenia, to collect long-term data on safety and tolerability of~     oral Ziprasidone~   "
260240|NCT00143338|"~     To examine the lung when people with diabetes take an inhaled form of insulin, compared to~     subcutaneous insulin.~   "
260241|NCT00143325|"~     Open-label comparison of standard 12-week regimen of varenicline with standard 10-week~     regimen of transdermal nicotine patch for smoking cessation.~   "
260242|NCT00143312|"~     To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell~     transplants~   "
260243|NCT00143299|"~     The primary purpose of this study is to obtain safety information on cigarette smokers~     treated with 52 weeks of varenicline regardless of smoking status.~   "
260244|NCT00143286|"~     The primary purpose of this study is a comparison of abstinence maintenance in subjects~     randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded~     to an intial 12-week open label course of varenicline, with post-treatment follow-up of~     smoking status to Week 52.~   "
260245|NCT00143273|"~     To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD~     in postmenopausal Asian women.~   "
260246|NCT00143260|"~     Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile~     dysfunction~   "
260247|NCT00143247|"~     This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera®~     (inhaled insulin).~   "
260252|NCT00143182|"~     Bipolar disorder is characterized by mood swings that range from high (manic) to low~     (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed~     episodes). Asenapine is an investigational medication for the treatment of manic or mixed~     episodes of bipolar disorder. Patients who completed the 3 week trial (A7601004 or A7501005)~     continued on the same treatment that they received in the short term study: asenapine or~     olanzapine (a medication already approved for the treatment of bipolar mania) for 9~     additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the~     9 week extension study was unblinded. Patients treated with placebo in the 3 week short term~     study were crossed over and treated with Asenapine in the 9 week extension study. Patients~     who complete the 9 week extension study were eligible to continue in another extension~     (A7501007) study for an additional 40 weeks.~   "
260253|NCT00143169|"~     To validate the morphine-sparing effect and safety of parecoxib administered intravenously~     for the treatment of Chinese subjects with postoperative pain following gynecological or~     orthopedic surgery.~   "
260254|NCT00143156|"~     To evaluate the efficacy and safety of pregabalin administered twice a day compared to~     placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.~   "
260255|NCT00143143|"~     The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in~     patients with partial seizures.~   "
260256|NCT00143130|"~     To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive~     treatment in patients with partial seizures.~   "
260257|NCT00143117|"~     To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.~   "
260258|NCT00143104|"~     To examine the lung when people with diabetes take an inhaled form of insulin, compared to~     subcutaneous insulin.~   "
260259|NCT00143091|"~     A six week, fixed dose, double-blind, double-dummy, placebo, and active controlled,~     multicentre trial to evaluate the safety and efficacy of CP-316,311 in outpatients with major~     depressive disorder.~   "
260260|NCT00143078|"~     The purpose of this study is to examine how obesity and weight loss following bariatric~     surgery affect reproductive function. The study is particularly interested in how changes in~     hormones (those produced in the stomach and fat tissue) following weight loss affect~     reproductive function. Specifically, we, the researchers at Penn State University, propose to~     characterize reproductive abnormalities in morbidly obese men and women. We hypothesize that~     morbid obesity leads to reproductive abnormalities in men and women. We plan to examine the~     short-term effects of alteration in GI hormones after bariatric surgery on reproductive~     function. We hypothesize that bariatric surgery radically alters GI hormone expression,~     resulting in immediate changes to the hypothalamic-pituitary-gonadal axis in men and women.~     Lastly, we, the researchers, plan to examine the long-term effects of weight loss and changes~     in adipokines on reproductive function. We hypothesize that the changes in adipokine levels~     resulting from fat mass reduction lead to substantial long-term improvements in reproductive~     function and fertility. We also hypothesize that there are sexual dimorphisms in adipokine~     levels following weight loss, with women experiencing larger changes than men.~   "
260261|NCT00143065|"~     This purpose of this study is to assess the toxicity and the rate of complete and overall~     response using fludarabine, rituximab, and alemtuzumab to treat patients with B-chronic~     lymphocytic leukemia or small lymphocytic leukemia who have received previous treatment.~   "
260262|NCT00143052|"~     The purpose of this study is to investigate how the bones of hirsute women are different from~     bones of healthy women. The change in hormone content in the blood will also be investigated.~     The study can be used to evaluate whether it will be relevant to bone scan all newly referred~     hirsute women.~      Hirsute women are often over-weight and often have an increased amount of the male sex~     hormone in their blood. Their blood tests often show changes reminding of the ones seen in~     diabetic patients.~      All hirsute women referred to the department will undergo an investigation revealing the~     reason for the increased hair growth. The investigation includes clinical investigation~     (height, weight and degree of hair growth), blood tests (for hormone status and bone status~     analysis) and bone scanning of the abdomen (body composition).~      The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women~     with normal hair growth. They are matched by body weight, since weight has great importance~     for the bone mineral content and thereby for osteoporosis in the long run.~   "
260263|NCT00143039|"~     The objective of this pilot study is to prospectively evaluate amniotic fluid of pregnancies~     complicated by non-immune hydrops and severe symmetrical intrauterine growth restriction by~     tandem mass spectrometry for inborn errors of metabolism.~   "
260264|NCT00143026|"~     This study examines the effect of treatment of levodopa/entacapone on quality of life, as~     measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients~     with no or minimal, non-disabling motor fluctuations.~   "
260265|NCT00143013|"~     Type 2 diabetes is a disorder of the metabolic system that greatly affects individual health~     and imposes significant cost for society on health care. It is necessary to initiate research~     with emphasis on improvement on quality of life and reduce the serious complications as a~     result of type 2 diabetes.~      In type 2 diabetes insulin resistance and impairment of insulin secretion by beta-cells are~     the major pathophysiological defects and characterized by raised plasma glucose levels.~     Today, little is known about gene regulation and biochemical pathways involved in the~     disease.~      Bioinformatics and gene expression microarrays (GEM) will be applied to gain insight into the~     molecular pathophysiology of type 2 diabetes. The simultaneous monitoring of thousands of~     genes in parallel can identify novel genes and entire biochemical pathways that are~     dysregulated at the transcriptional level. Affymetrix Inc. chips or spotted arrays will be~     applied as DNA microarray tools. Bioinformatic software programs and databases will be~     employed as data mining tools in order to perform statistical analysis, cluster analysis and~     biochemical pathway analysis.~      Biopsies from skeletal muscle and adipose tissue from both diabetics and nondiabetics will be~     applied. Changes in genes and biochemical pathways between diabetics and nondiabetics and~     functional relationships between adipose tissue and skeletal muscle will be investigated.~      Grouping of subtypes in type 2 diabetes will be performed and a classification system will be~     constructed. Building a classifier may provide better and more precise diagnosis of type 2~     diabetes.~      Major advances in health science of type 2 diabetes thus seems to be promising and paving the~     way for individual treatment based on a more precise diagnosis.~   "
260267|NCT00142987|"~     Recent literature has demonstrated that the group of IBS sufferers who experience mixed bowel~     habits may be more similar to IBS-C patients than IBS-D patients. This study will evaluate~     the efficacy and safety of tegaserod 6 mg b.i.d. in women with IBS and mixed bowel habits,~     excluding those with predominant diarrhea.~   "
260268|NCT00142974|"~     This study is being done to evaluate the safety, tolerability and satisfactory relief of~     tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic~     gastropathy.~   "
260269|NCT00142961|"~     Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment~     for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in~     treating adolescents who abuse marijuana and have ADHD. In addition, this study will assess~     whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will~     determine whether atomoxetine improves treatment retention and progress in adolescents with~     ADHD and marijuana dependence.~   "
260270|NCT00142948|"~     Naltrexone is a medication that is currently used to treat drug and alcohol addiction.~     Guanfacine is a medication that is currently used to manage the withdrawal symptoms in~     individuals undergoing opioid detoxification. A combination of these two medications may be~     beneficial in reducing heroin use in individuals addicted to heroin. This study will evaluate~     the effectiveness of naltrexone and guanfacine, alone and in combination, at reducing heroin~     use in heroin addicts.~   "
260271|NCT00142935|"~     Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to~     opiates. Many of these individuals pass through a correctional setting each year, creating an~     opportunity for linkage to substance abuse treatment. The purpose of this study was to~     evaluate the effectiveness of initiating opiate replacement therapy prior to release from~     incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study~     evaluated the effectiveness of short-term payment versus non-payment of community opiate~     replacement therapy immediately following release from incarceration.~   "
260272|NCT00142922|"~     Performance of self-care recommendations is key to the successful treatment of diabetes.~     However, many patients have difficulty adhering to diabetes self-care recommendations. Recent~     results from our own studies and others have identified specific barriers to diabetes~     self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the~     Breaking Down Barriers Program, that addresses barriers and therefore leads to improved~     adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111~     type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program,~     2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We~     hypothesize that those assigned to the Breaking Down Barriers group will improve self-care~     behaviors and glycemic control more than those in the two control groups. We will follow~     study subjects for one year to determine whether their self-care behaviors and glycemic~     control improved and if the improvement was maintained over time.~   "
260273|NCT00142909|"~     Lofexidine is an experimental medication that may be beneficial in reducing opiate withdrawal~     symptoms, such as sleep difficulty, anxiety, and tension. The purpose of this study is to~     determine whether lofexidine in combination with naltrexone can improve an individual's~     ability to cope with stress and subsequently increase the chances of remaining abstinent from~     opiates.~   "
260274|NCT00142896|"~     Individuals with opioid addiction often experience serious withdrawal symptoms that may make~     relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by~     chronic conditions such as cancer or joint pain, may also be effective at reducing opioid~     withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing~     withdrawal symptoms in individuals addicted to opioid drugs.~   "
260275|NCT00142883|"~     Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that~     transmits information within and from the brain to all parts of the body. By lowering the~     level of another neurotransmitter called dopamine, GABA may have the ability to diminish~     cocaine cravings in addicts. The purpose of this study is to gather information on the~     interaction between cocaine and selected GABA enhancing medications in individuals addicted~     to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine~     addiction.~   "
260276|NCT00142870|"~     A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy~     marijuana use. Bupropion (Zyban) is a medication currently used to treat withdrawal symptoms~     associated with tobacco use. The purpose of this study is to determine if bupropion will help~     individuals stop using marijuana.~   "
260277|NCT00142844|"~     Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond~     poorly to existing treatments and have received little research attention in the past. The~     purpose of this study is to determine whether the combination of naltrexone and disulfiram is~     useful in decreasing alcohol use and cravings in people diagnosed with both cocaine and~     alcohol dependence.~   "
260278|NCT00142831|"~     Existing and new pharmacotherapies along with prevention efforts are key to improving smoking~     cessation rates and reducing the premature morbidity and mortality associated with tobacco~     use. A number of individuals suffer from both nicotine dependence and depression. The purpose~     of this study is to determine the effectiveness of bupropion used in combination with the~     nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine~     dependent individuals also diagnosed with depression.~   "
260279|NCT00142818|"~     Modafinil is a medication that may enhance mood and increase energy in cocaine addicts, which~     may be useful in preventing cocaine relapse. Naltrexone is a medication that is currently~     used to treat drug and alcohol addiction. A combination of these two medications may be~     beneficial in reducing drug and alcohol use in individuals undergoing substance abuse~     treatment. The purpose of this study is to evaluate the effectiveness of modafinil and~     naltrexone, alone and in combination, at reducing drug and alcohol use in individuals~     addicted to cocaine and alcohol.~   "
260280|NCT00142805|"~     The purpose of this study is to evaluate the safety, tolerability and effectiveness of~     Ketasyn™ administered once a day for ninety days in subjects with mild to moderate, probable~     Alzheimer's disease.~   "
260281|NCT00142792|"~     Stroke is the leading cause of activity limitation among older adults in the United States.~     NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor~     ability and decreasing activity limitation caused by stroke. This study will research the~     effects of two types of NMES on reducing motor impairment and activity limitation.~   "
260282|NCT00142779|"~     Cocaine addiction is a serious health problem with no available medical treatment for~     preventing relapse. Fluoxetine, a medication that is currently used to treat depression and~     anxiety disorders, may also be effective at diminishing cocaine use in individuals with~     severe cocaine addiction. This study will evaluate the effectiveness of fluoxetine at~     reducing cocaine use in individuals addicted to cocaine and opioids who are concurrently~     receiving methadone treatment.~   "
260283|NCT00142766|"~     The purpose of this two-year project is to pilot test an intervention to change sedation~     management in pediatric patients supported on mechanical ventilation for acute respiratory~     failure in the pediatric intensive care unit (PICU). While ensuring patient comfort is an~     integral part of pediatric critical care, analgesic and sedative use in this patient~     population is associated with injury; specifically, comfort medications may depress~     spontaneous ventilation and prolong the duration of mechanical ventilation. Additionally,~     drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome~     (chemical withdrawal) when the patient no longer requires sedation. Alternatively, suboptimal~     comfort management contributes to the patient not breathing synchronously with the ventilator~     and/or self-removal of breathing tubes.~      Our group has developed and validated a nurse-implemented sedation algorithm (set of specific~     instructions) to guide titration of comfort medications that may optimize patient comfort and~     reduce the risk of under-medication, but this algorithm needs to be evaluated further. We~     hypothesize that pediatric patients managed per sedation protocol will experience fewer days~     of mechanical ventilation than patients receiving usual care. This research has the potential~     of revolutionizing sedation practices that are driven by and synchronized to patient needs.~   "
260284|NCT00142753|"~     This is an exploratory, laboratory-based evaluation of cellular immune response to~     immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents.~     This is a substudy of ATN 024 and ATN 025. This substudy will compare cellular immune~     response in responders and nonresponders to immunization and also evaluate the relationship~     of these factors to the persistence of known correlates of serologic protection for the~     hepatitis B virus.~   "
260285|NCT00142740|"~     This laboratory-based substudy of an effectiveness trial of two Hepatitis B vaccines in~     HIV-negative youths is being done to evaluate the genetic contribution to the individualized~     immune response.~   "
260286|NCT00142727|"~     The purpose of this study is to examine the acute agonist and antagonist effects of a full~     opioid agonist medication, an opioid antagonist medication, and a partial opioid agonist~     medication in individuals who have different levels of physical opioid dependence.~   "
260287|NCT00142714|"~     The long term aims of this project are to 1) Understand the effect of varying degrees and~     levels of SCI and dysfunction(SCI/D)on females sexual response: 2) Identify the specific~     neuronal pathways involved in female sexual responses; and 3) Develop and evaluate new~     assessment and treatment methods for neurogenic sexual dysfunction in women.~   "
260288|NCT00142701|"~     To test a practical, theory-based intervention to achieve long-term behavior change for~     postmenopausal women with Type 2 diabetes at high risk for developing coronary heart disease~     (CHD).~   "
260289|NCT00142688|"~     The purpose of this study is to examine psychosocial mediators of exercise behavior.~   "
260290|NCT00142675|"~     A randomized controlled trial to evaluate the effects of a 12-month telephone-supervised,~     home-based physical activity intervention, delivered via health educators versus supervised,~     trained peers, on physical activity patterns. Inactive men and women ages 50 years and older~     will be randomly assigned to one of these two programs or to an attention-control arm.~   "
260291|NCT00142662|"~     To investigate two cafeteria-based methods of weight gain prevention in overweight men and~     women.~   "
260292|NCT00142649|"~     To develop a culturally tailored intervention intended to promote adherence to nutrition and~     physical activity regimens designed to result in weight loss for African American women.~   "
260293|NCT00142636|"~     Patients with Chronic Kidney Disease (CKD) have been shown to have high coronary calcium~     scores (CAC), but the temporal association between Glomerular Filtration Rate, CVD risk~     factors and CAC has not been described. This is a single-center, longitudinal, observational~     study. Subjects included adults aged 18 years to 65 years old without preexisting coronary~     artery disease (CAD). The CKD subjects (GFR < 60 ml/min) and the control subjects (GFR~     >/=60ml/min) were recruited. Laboratory measurements and MDCT scan were performed at baseline~     and after 12 months. Baseline CAC and average intact parathyroid hormone (iPTH) level were~     significantly greater in the CKD group. Baseline CAC scores of the CKD group were twice the~     value of the control group; however, CAC scores over one year were unchanged from baseline.~   "
260294|NCT00142623|"~     The purpose of this study is to develop and evaluate the efficacy of five tailored DVDs in~     reducing exposure to environmental tobacco smoke (ETS) among low income pregnant/postpartum~     women.~   "
260295|NCT00142610|"~     This study will determine if airway antioxidant levels in allergic asthmatics are enhanced~     with a combination of vitamin E and vitamin C therapy.~   "
260296|NCT00142597|"~     This study will determine the effectiveness of acupuncture versus a placebo in altering brain~     activity and relieving pain due to fibromyalgia.~   "
260297|NCT00142584|"~     The purpose of this study is to evaluate long-term safety,tolerability and blood pressure~     effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be~     given alone or in combination with other drugs that are commonly used in the treatment of~     hypertension~   "
260298|NCT00142571|"~     The purpose of this study is to compare the drug gemcitabine to two drugs, gemcitabine and~     docetaxel, to find out which treatment is better for people with sarcomas.~   "
260299|NCT00142558|"~     A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute~     gout.~   "
260300|NCT00142545|"~     The current protocol is designed to satisfy the need for a compassionate use treatment~     protocol as well as for a long-term open label follow-up study.~   "
260301|NCT00142532|"~     Pain after surgery for lung cancer (thoracotomy) may persist for years and require long-term~     analgesic use. Prior studies have shown that acupuncture reduces pain and medication use in~     the early post-operative period after abdominal surgery, suggesting that acupuncture may have~     a role in preventing chronic post-thoracotomy pain. This study is being done in order to~     determine the effects of acupuncture on pain in patients undergoing surgery for lung cancer.~   "
260302|NCT00142519|"~     This is a randomized Phase II study testing the effectiveness of the combination of morphine~     and methadone versus morphine alone in relieving pain. A second goal is to further evaluate~     any side effects of the combination of morphine and methadone.~   "
260303|NCT00142506|"~     Radiation sometimes affects the ability for a person to have a normal erection. Complete loss~     of erections after radiation treatment can happen in 40-50% of treated patients. There are~     medications, like sildenafil (also known as Viagra), that can help the ability to get back~     erections in almost 70% of such patients.~      The purpose of this study is to see if taking Viagra every day starting right before, during~     and for about 6 months after treatment, could reduce the risk of long-term erectile~     dysfunction.~   "
260304|NCT00142493|"~     The purpose of this research is to understand how some of the drugs commonly used in~     anesthesia impair memory. We are particularly interested in whether the emotion associated~     with a memory influences how well these drugs are able to block memory. We are studying four~     commonly used drugs—propofol, thiopental, midazolam, and dexmedetomidine, all of which may~     have slightly differing effects. We will also study an inactive substance, called a placebo,~     that should have no effect. The results of this study will provide information that will be~     useful in understanding how memory works, how these drugs affect memory, and possibly why~     some people don't have their memory blocked as easily as others.~   "
260305|NCT00142480|"~     The main purpose of this study is to test the safety and effectiveness of oxaliplatin,~     bevacizumab, and capecitabine given in combination with radiation therapy to see what effects~     (good or bad) they have on patients with biliary tract and gallbladder cancer.~   "
260306|NCT00142467|"~     The purpose of this study is to test the safety of bevacizumab when given in combination with~     gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with~     hepatocellular carcinoma.~   "
260307|NCT00142454|"~     This study evaluates a cancer vaccine in melanoma patients who have resected melanoma but are~     at high risk for recurrence (stages IIB-III). This is a single arm, open label, pilot/phase I~     study evaluating safety and immunogenicity of NY-ESO-1 protein vaccination with Imiquimod as~     an adjuvant.~      Imiquimod is a FDA approved immune response modifier for the treatment of HPV associated~     genital warts (but used for a different indication here) and has been shown to attract and~     mature dendritic cells in areas of topical application. This will be utilized in this~     application to inject a protein vaccine into this site, to prime and boost anti-NY-ESO-1~     immune responses.~      9 patients will be treated to receive 4 vaccination cycles, 21 days apart. Each vaccination~     cycle consists of topical application of Imiquimod 250mg to healthy skin of extremities for~     the first five days of each cycle and intradermal injection of NY-ESO-1 protein 100mcg to the~     pretreated area on day 3.~      Immunization will be assessed by T-cell assays, NY-ESO-1 specific antibody titers, and~     evaluation of 3 small skin biopsies.~   "
260308|NCT00142441|"~     To investigate the effect of pulse width on the treatment response of keloidal and~     hypertrophic sternotomy scars to a 595-nm pulsed dye laser~   "
260309|NCT00142428|"~     The main purpose of this study is to begin to collect information and to try to learn whether~     or not cetuximab works in treating patients with unresectable or metastatic hepatocellular~     carcinoma.~   "
260310|NCT00142415|"~     This was a Phase I/II, single-center, dose-escalation study.~     177-Lutetium-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-cG250~     (177-Lu-DOTA-cG250) was administered at a starting dose of 30 mCi/m^2 of 177-Lu (fixed dose~     of 10 mg cG250) and escalated in increments of 10 mCi/m^2 of 177-Lu in sequentially enrolled~     cohorts according to a standard 3 + 3 design until determination of the maximum tolerated~     dose (MTD). The primary objectives were to determine the safety, targeting, and dosimetry of~     177-Lu-DOTA-cG250 in subjects with advanced renal cell carcinoma. The secondary objective was~     measurement of tumor response according to the Response Evaluation Criteria in Solid Tumors~     (RECIST) version 1.0.~   "
260311|NCT00142402|"~     Deficits in new learning and memory in MS are a major complaint of patients, and have been~     noted to be a significant contributor to disability by numerous researchers. Modafinil is a~     psychostimulant medication, FDA approved for the treatment of Narcolepsy, with potential~     application for the treatment of learning and memory dysfunction in MS. This randomized~     clinical trial tests the efficacy of Modafinil for the treatment of new learning and memory~     deficits in MS.~      Twenty subjects with clinically definite MS and objectively documented new learning~     impairment will be included in the study. All subjects will undergo baseline~     neuropsychological testing and EDSS to document current levels of functioning in new learning~     and memory abilities. Subjects will then be randomly assigned to either group 1 or group 2.~     Group 1 (n=10) will first undergo treatment with Modafinil (200 mg once per day in the~     morning) for 2 weeks. They will then undergo follow-up neuropsychological assessment and~     follow-up EDSS to evaluate any medication effects. After the follow-up evaluation, there will~     be a washout period of one week in which no medication will be administered. Group 1 will~     then receive a placebo medication for 2 weeks. A second follow-up evaluation will be~     conducted following this latter arm of the study. Group 2 (n=10) will follow the same~     pattern, but will receive the placebo medication during the first arm of the study and~     Modafinil during the 2nd arm of the study. The subjects and the experimenter administering~     the neuropsychological evaluation will be blind to group membership.~   "
260312|NCT00142389|"~     This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant~     mothers, followed by pneumococcal conjugate immunization of their children is designed to~     assess the effects of these strategies on the immunogenicity and safety of both vaccines. We~     hypothesize that maternal followed by infant immunization will be safe and will provide~     higher levels of antibody from birth through 12 months of age.~   "
260313|NCT00142376|"~     The study is a chart review of all children admitted over a two year period with the~     diagnosis of acute respiratory distress syndrome. Short term outcomes, such as mortality,~     length of ventilation and length of stay, will be reviewed. Factors that impact these~     outcomes will also be reviewed.~   "
260341|NCT00141999|"~     The purpose of this study is to determine the immune response to an additional (booster) dose~     of hepatitis B vaccine 5-14 years after a three dose series was given~   "
260385|NCT00141427|"~     To assess the clinical improvement (change in seizure frequency), safety and tolerability of~     patients with partial seizures following adjunctive therapy of pregabalin BID in addition to~     existing standard AEDs.~   "
260314|NCT00142363|"~     The DNA and Cell Bank of Instituts Federatifs de Recherche (IFR) of Neurosciences has been~     running for the last 15 years at the Institut National de la Santé Et de la Recherche~     Médicale (INSERM) Unit 679 (former unit 289). Since its creation, this structure has been the~     support of research projects in genetics for neurological and psychiatric disorders. The~     cohorts established have led to discoveries in monogenic disorders, such as cerebellar~     ataxias, spastic paraplegias, frontotemporal dementias, epilepsies, Parkinson’s and~     Alzheimer’s disease, Charcot-Marie-Tooth disease and related entities. The research projects~     based on the study of the genetic bases in Parkinson’s disease and epilepsies are especially~     developed for this grant.~      Concerning Parkinson’s disease, the project is based on the extension of the existing cohort~     throughout the French Parkinson’s Disease Study Group network. Concerning epilepsies, this~     project is the occasion to build this network with the constitution of a new cohort.~      The specific aims of the scientific projects are the following for Parkinson’s disease:~        -  to evaluate the frequency, the nature and the phenotype associated with parkin mutations~          in familial or sporadic forms of the disease, according to the age at onset, and~        -  to identify the genetic susceptibility factors in Parkinson’s disease with the study of~          affected sibpairs and with case/controls association studies.~      For epilepsies, the aims are:~        -  to evaluate the frequency, the nature and the phenotype associated with SCN1A, SCNab and~          GABR2 gene mutations in familial or sporadic forms of the affection associated with~          febrile seizures, and~        -  to search for an intervention SCN1A, SCN1B and GABRG2 as susceptible genes in these~          forms of epilepsies.~   "
260315|NCT00142350|"~     To investigate the superiority of a combination of irinotecan and cisplatin and the~     non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer~   "
260316|NCT00142337|"~     The purpose of this study is to determine whether providing zidovudine (ZDV) and didanosine~     (ddI) during labor and for one month postpartum can reduce the selection of nevirapine (NVP)~     resistance mutations postpartum in women who received a single dose of nevirapine during~     labor and standard ZDV prophylaxis for the prevention of mother to child transmission of HIV.~   "
260317|NCT00142324|"~     Primary Aim~      To determine whether;~        -  Donepezil is significantly better than placebo in the management of agitation in~          Alzheimer's Disease that has not responded to, or is inappropriate for a standardised~          brief psychosocial treatment~      Secondary Aims~      To determine whether;~        -  Donepezil has a significant positive or negative impact upon quality of life compared~          with placebo~        -  whether there is a significant difference between Donepezil and placebo with respect to~          cognitive performance~        -  the cost effectiveness of the pharmacological treatment for agitation~   "
260318|NCT00142311|"~     Parkinson’s disease is one of the most frequent neurodegenerative diseases, and for which the~     mechanisms remains unknown. Since the implication of susceptibility factors is highly~     suspect, we have recently shown that one monogenic form due to alterations in the Parkin gene~     was responsible for an important proportion of early onset familial and isolated cases.~     Nevertheless, it not has been determined yet the relationship between idiopathic Parkinson’s~     disease and secondary Parkinson’s disease with a Parkin gene mutation at the clinical,~     neuropsychological, metabolic and physiopathological levels. For establishing~     phenotype-genotype correlations, we propose to compare the phenotype of patients carrying a~     Parkin mutation (parkin « + », n=25) to those of early onset parkinsonians without a Parkin~     mutation (Parkin ” - ”, n = 25), and for some aspects (neuropsychological, behavioural and~     psychiatric evaluations) to the healthy brothers and sisters of Parkin cases “+”(n = 25). The~     evaluation will carry on the clinical aspects (quantification of the parkinsonian syndrome~     and reactivity to levodopa, neuropsychological, behavioural and psychiatric evaluations),~     molecular (types of abnormalities in the Parkin gene) and metabolic (PET – tomography by~     positron emission) of the disease.~      Parkinson’s disease caused by Parkin gene mutations is associated with an important and~     homogeneous loss of dopaminergic neurons of the substantia nigra pars compacta, which is~     different from those observed during the idiopathic Parkinson’s disease. The corresponding~     dopaminergic deficit should be associated with an excellent reactivity to levodopa, to a~     cognitive deficit and to behavioural and/or psychiatric attitudes, in relation with the~     massive alteration of dopaminergic efferences.~      This multidisciplinary approach on Parkin cases will be performed in the centers for of~     clinical investigations of Grenoble and Paris, with the help of the French Parkinson’s~     Disease Study Group, and two centers for TEP (Lyon and Orsay). This project will allow to a~     better definition of diagnostic criteria of Parkin « + » cases, which will help for the~     molecular diagnosis in early onset cases, and will study precisely the clinical, psychiatric~     and metabolic consequences of a massive and homogeneous dopaminergic denervation, which seems~     to be different of idiopathic Parkinson’s disease.~   "
260319|NCT00142298|"~     This trial is being conducted as an open-label, extended-term study for patients with chronic~     hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.~   "
260320|NCT00142285|"~     The purpose of this study is to determine whether zinc can be used in combination with~     standard antibiotics to reduce the duration of illness and the likelihood of treatment~     failure among children less than two years old who have non-severe, outpatient pneumonia.~   "
260321|NCT00142272|"~     The study will be conducted to compare the efficacy and safety of a single dose of~     ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension~     administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children,~     aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139.~      We hypothesize that single dose ciprofloxacin would result in similar outcome in the~     clinicalcurewith that of erythromycin given in multiple doses.~   "
260322|NCT00142259|"~     The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain~     stimulation of the internal globus pallidus for treating idiopathic generalized or severe~     segmental dystonia.~   "
260323|NCT00142246|"~     This study seeks to establish whether intermittent preventive treatment (IPT) can reduce~     malaria among school-going children and its consequent impact on school performance.~   "
260324|NCT00142233|"~     This is a multi-centre randomised phase III, double blind, placebo controlled, parallel~     group, outpatient study in patients diagnosed with hereditary pancreatitis and idiopathic~     chronic pancreatitis.~      The hypothesis to be tested is a 30% reduction in the number of days due to pancreatitis from~     12.5 days per year to less than nine days per year under the treatment with magnesium or an~     antioxidant cocktail called ANTOX.~      A total of 240 patients will be randomised to one of three treatment groups in order to~     compare pancreatic pain over a twelve month period.~   "
260325|NCT00142220|"~     We study whether an increased proportion of omega-3-fatty acids (contained in fish oil) in~     the nutrition of critically ill patients reduces systemic inflammation.~   "
260365|NCT00141687|"~     For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and~     6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the~     likelihood of cesarean section (CS)?~   "
260386|NCT00141414|"~     To evaluate the long-term safety of pregabalin in refractory partial epilepsy.~   "
260326|NCT00142207|"~     The purpose of this study is to compare the efficacy and cost-effectiveness of three~     alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone~     area of low transmission in the East African Highlands.~      The strategies being compared are:~        -  intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)~        -  an insecticide treated net (ITN), and~        -  intermittent preventive treatment with SP plus an ITN~      In addition to the main individually-randomised trial, outcome data was subsequently also~     gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS)~     as part of a non-randomised district-wide control programme to compare the impact of IRS with~     the three intervention arms.~   "
260327|NCT00142194|"~     Atrial fibrillation is an abnormal heart beat that starts in the upper parts of the heart and~     can cause stroke or death, if untreated. In general, treatments are not very effective, with~     frequent relapses of the abnormal heart beats. One explanation for the high relapse rate is~     that the treatments might not address the underlying cause of atrial fibrillation. Recently,~     the investigators have found that atrial fibrillation is associated with increased oxidative~     stress. This is a condition where abnormal oxygen forms are produced. These forms harm the~     cells of the heart, causing them to beat abnormally. The investigators have found increased~     oxidative stress in pig and mouse models of atrial fibrillation. They would like to see if~     oxidative stress is present in humans with atrial fibrillation. In this study, they will~     compare blood markers of oxidative stress between patients with and without atrial~     fibrillation. It is the expectation that participants with atrial fibrillation will have more~     abnormal blood markers of atrial fibrillation. This study requires participants to visit~     their doctors, undergo a history and physical examination, and give blood only once.~   "
260328|NCT00142181|"~     The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H~     antibody in the treatment of lymphoplasmacytic lymphoma.~   "
260329|NCT00142168|"~     The purpose of this study is to determine the number of patients with Waldenstrom's~     macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab,~     what the side effects are and how long the benefit will last.~   "
260330|NCT00142155|"~     The purpose of this study is to determine if the type of Fc gamma RIIIa receptor that a~     particular patient's immune cells possess influences how they respond to rituximab and other~     monoclonal antibodies.~   "
260331|NCT00142129|"~     The purpose of this study is to evaluate how tumors in patients with Waldenstrom's~     macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects~     (good and bad) it has on the cancer.~   "
260332|NCT00142116|"~     The purpose of this study is to determine the percentage of people who can attain remission~     and the length of time such responses to therapy are sustained, as well as the side effects~     that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.~   "
260333|NCT00142103|"~     1. To characterize the tolerability profile of subcutaneous (SC) CPG 10101 alone, with~          pegylated interferon, ribavirin or both pegylated interferon and ribavirin when~          administered weekly for twelve weeks in relapsed HCV positive subjects.~        2. To assess the effect of subcutaneous (SC) CPG 10101 alone, with pegylated interferon,~          ribavirin or both pegylated interferon and ribavirin on serum Hepatitis C Virus (HCV)~          RNA concentrations~   "
260334|NCT00142090|"~     The purpose of this study is to find out if 3% hypertonic saline (salt-water solution) given~     in a vein improves the headache that may be caused by a concussion. 3% hypertonic saline may~     also improve some of the other symptoms that may be caused by concussion (for example:~     confusion, nausea, vomiting).~      This research is being done because there have been previous experience which suggests that~     3% hypertonic saline has been beneficial in the treatment of children with more severe brain~     injury.~   "
260335|NCT00142077|"~     The purpose of this study is to determine whether personally controlled electronic health~     records can be used for health promotion in a workplace setting.~   "
260336|NCT00142064|"~     The purpose of this study is to determine if a single application of Lidocaine gel topical~     anesthesia is as effective in decreasing the discomfort associated with urinary~     catheterization as two applications, within our pediatric population. Currently, two~     applications is our standard of care within our pediatric Radiology Department. Urinary~     catheterization is the process of placing a flexible tube into the urinary opening (urethra),~     to drain urine or instill radiographic solution for study of the anatomy and/or function of~     the urinary system. Members of the study team hypothesize equivalence in the observer~     reported catheterization pain scores as measured by the FLACC pain scale. The study is~     designed to obtain conclusive data to guide clinical practice.~      The study team hypothesizes that statistically similar levels of analgesia will be observed~     with the single application procedure as compared to the multiple application technique.~   "
260337|NCT00142051|"~     Randomized, double blind placebo controlled clinical trial to evaluate effectiveness and~     safety of inhaled nitric oxide for the treatment of sickle cell painful crisis in pediatric~     patients with sickle cell disease.~   "
260338|NCT00142038|"~     Up to date there is no worldwide accepted standard chemotherapy for the 1st-line treatment of~     advanced or metastatic gastric cancer.A combination of epirubicin, cisplatin and 5-FU (ECF)~     is the best examined combination and widely used. Recent studies (Thuss-Patience et al, J.~     Clin. Oncol. 2005) could show that a combination of docetaxel and 5-FU might be similarly~     effective as ECF. 5-FU and docetaxel +/- cisplatin combinations are investigated by many~     groups and may be a future reference treatment. Many data suggest that 5-FU infusion can be~     replaced by oral capecitabine with equal efficacy.~      As docetaxel/5-FU is probably similarly effective as epirubicin/cisplatin/5-FU and a~     replacement of 5-FU infusion by capecitabine makes the chemotherapy more comfortable for the~     patient we investigate in this study a chemotherapy of docetaxel and capecitabine as 1st-line~     therapy for metastatic or advanced gastric cancer.~   "
260339|NCT00142025|"~     The purpose of this study is to determine whether antiepileptic drug oxcarbazepine is~     effective in the treatment of chronic asthma.~   "
260340|NCT00142012|"~     The overarching goal of this initiative is to reduce the prevalence and occurrence of obesity~     and increase the remission of obesity in children and adolescents through implementation of a~     Comprehensive School Nutrition Policy designed to promote changes in the school environment~     that will reinforce students’ development of healthy eating and physical activity patterns~     inside and outside of school.~   "
260342|NCT00141986|"~     Type 1 diabetes is a common chronic disease of childhood. It is not yet preventable. Multiple~     daily injections of insulin, tests of blood sugar, and careful dietary planning are required~     lifelong to prevent long-term complications such as blindness and kidney failure. Recent~     studies of potential risk factors in children with diabetes, along with studies revealing the~     immunologic properties of vitamin D, and experiments in animals suggest higher doses of~     vitamin D may prevent type 1 diabetes. For proof for human children, a randomized trial will~     compare groups at risk randomly assigned to receive either the usual vitamin D supplement or~     a higher amount, 2000 IU daily. This initial study is a small scale test of procedures.~   "
260343|NCT00141973|"~     A systemic treatment with corticosteroids has been advocated for various bacterial infectious~     diseases. Since the production of CRP is down-regulated by corticosteroids, a smaller~     increase or a more rapid decrease of this acute phase protein will:~        1. suggest attenuated systemic inflammation, but~        2. does not necessarily reflect adequate therapy of the infection.~      For several reasons (good diagnostic tool for sepsis, induction not decreased by~     immunosuppressive therapy), procalcitonin could be a better marker for activity of sepsis in~     patients under corticosteroids. As this issue has not yet been examined the investigators~     will prospectively study the time-course of PTC and CRP in a well-defined septic patient~     group, that in adjunction to antibiotic therapy also received systemic corticosteroid~     treatment and compare it to a similar group without corticosteroid treatment.~   "
260344|NCT00141960|"~     Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in~     the esophagus and heartburn, which may sometimes interfere with daily activities due likely~     to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do~     not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have~     subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in~     Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of~     famotidine in subjects with non-erosive GERD.~   "
260345|NCT00141947|"~     In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069;~     4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) on~     severity of psychopathology, cognitive impairment, and quality of life in schizophrenia~     patients in an open label trial. The rationale behind add-on oral bexarotene to ongoing~     antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation~     hypothesis (Goodman, 1995) and the growth factors deficiency and synaptic destabilization~     hypothesis (Moises et al, 2002) of schizophrenia. In this clinical trial, a novel regimen of~     low dose bexarotene (Targretin, 75 mg/day) will be added for 6 weeks to the standard~     treatment of 15 schizophrenia patients on stable antipsychotic treatment. Participants will~     be assessed at baseline and after 2, 4 and 6 weeks of treatment. A battery of research~     instruments will be used for assessment of efficacy and safety (psychopathology, and side~     effects). In addition, cholesterol and triglyceride levels, liver and thyroid function tests~     and a blood cell count will be monitored at baseline and during therapy.~   "
260346|NCT00141934|"~     AD 452 is a new drug which is being developed for use in adult patients with RA. It is~     believed that AD 452 may modify the underlying disease of RA as well as improving RA~     symptoms, and in order to establish its efficacy and safety, AD 452 is being tested in a 3~     month study. Patients enrolled in this study will already be taking methotrexate for their RA~     and they will remain on methotrexate throughout the study. An earlier clinical study in 98~     subjects with RA on stable background therapy investigated the pharmacokinetics, safety and~     tolerability of AD 452 taken for one month. The drug was well tolerated and no significant~     drug related adverse events were reported.~   "
260347|NCT00141921|"~     The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in~     pediatric patients with moderate to severe psoriasis.~   "
260348|NCT00141908|"~     Preterm birth remains a major cause of perinatal morbidity and mortality in developing as~     well as in developed countries. Despite major clinical research efforts aimed at reducing the~     incidence of preterm births in the United States, the preterm birth rate reached its highest~     level in 2 decades, 11.9% in 2001, which translates to a 27% rise since 1981. Much of this~     increase may be accounted for by the increase in multiple gestations brought about by~     assisted reproductive technology. Twin gestations accounting for 20% to 25% of all~     pregnancies conceived following such procedures. Twin gestations are at a particularly~     increased risk of preterm labor and they deliver at a mean gestational age of 37 weeks~     compared to 40 weeks for singleton pregnancies. In a study by our group, we estimated that~     about 54.5% of twin gestations would deliver prior to 37 completed weeks of gestation; i.e.~     preterm.~      Evidence regarding efficacy of interventions designed to prevent preterm birth has been~     disappointing. Most well-designed clinical trials have failed to demonstrate any reduction in~     preterm births with such interventions as home uterine activity monitoring, reduced physical~     activity, administration of antibiotic or tocolytic therapy, and intensive and frequent~     antenatal follow ups. Recently, progesterone has shown some promise in the prevention of~     preterm birth among women with prior preterm births. Whether this intervention will prove~     effective in other populations, such as women with multiple gestations, remains to be seen.~      The objective of our study is to compare the effectiveness of weekly intramuscular injections~     of 17-alpha Hydroxyprogesterone Caproate, a natural metabolite of progesterone, in preventing~     delivery at less than 37 weeks of gestation in a population of 290 patients with twin~     gestations between 16 and 36 weeks of gestation compared to a placebo. The data generated~     will be invaluable in managing this group of patients that is considered at a very high risk~     for preterm labor and delivery.~   "
260349|NCT00141895|"~     Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the~     United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the~     manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several~     years, gained widespread acceptance to effect the medical termination of pregnancy in the~     second trimester, either alone or after pretreatment with mifepristone. The primary reasons~     for this prompt incorporation into standard practice include its low cost and the lack of~     stringent storage requirements.~      Vaginal administration seems to be more efficacious than when given orally. The use of~     sublingual misoprostol for first trimester abortions has been extensively investigated as~     evidenced by the large number of publications comparing sublingual to other routes of~     misoprostol for first trimester pregnancy termination, on the assumption that the sublingual~     route would have a similar efficacy of the vaginal route. In addition, the sublingual route~     would combine an easier administration with the added advantage of no restriction of mobility~     after administration. There has been no previous report in the literature comparing the use~     of misoprostol given sublingually to that given vaginally for the second trimester~     termination following intrauterine fetal death. Our aim is to compare efficacy, safety and~     patient satisfaction with misoprostol given vaginally (the current standard) to that given~     sublingually.~   "
260350|NCT00141882|"~     Randomized double-masked clinical trial of memantine in patients with glaucoma~   "
260351|NCT00141869|"~     This study will examine brain activity associated with the involuntary urges or uncontrolled~     movements, called tics, experienced by people who have Tourette syndrome (TS). Before~     people with TS actually develop a tic, whether it is a movement or a vocal tic (like a cough~     or bark), they feel the urge to tic. This study will look at brain activity during the time~     of this urge and how brain activity may differ in people with TS and without TS.~      Healthy normal volunteers and patients with TS between 14 and 65 years of age may be eligible~     for this study. Patients must have sensory tics in the facial region and must experience at~     least a moderate premonitory urge. Candidates are screened with a medical history, brief~     physical examination, and a questionnaire.~      Participants undergo the following procedures:~        -  Magnetoencephalography (MEG): This test records magnetic field changes produced by brain~          activity. During the test, the subjects are seated in the MEG recording room and a cone~          containing magnetic field detectors is lowered onto their head. Electrodes (small metal~          disks) are placed on both sides of the face near the jaw. The recording may be made~          while the subject receives small currents from the electrodes on the jaw. Subjects may~          be asked a few questions about what they felt during the procedure.~        -  Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves~          to obtain images of body organs and tissues. During the procedure, the subject lies on a~          table that can slide in and out of the scanner-a metal cylinder. Subjects may be asked~          to lie still for up to 30 minutes at a time. They can communicate with the staff at any~          time during the scan.~        -  Somatosensory evoked responses: This test examines how sensory information travels form~          the nerves to the spinal cord and brain in the nervous system. An electrode placed on~          the arm, leg, or face delivers a small electrical stimulus that may tingle and cause a~          twitch of a hand, foot, or face muscle. Additional electrodes may sometimes be placed on~          the scalp, neck, and over the collarbone to record how the impulse from the stimulus~          travels over nerve pathways.~      Patients in the study are contacted for follow-up after the study. Follow-up will be~     conducted by phone or email, according to the patients' convenience, and will consist of~     reaffirming that there were no adverse events.~   "
260352|NCT00141856|"~     The primary objective of this telephonic heart failure specific patient education study is to~     assess the incremental clinical, psycho-social, and functional lifestyle benefits of the~     Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease~     Management Program/Study) when added to standard care among veteran beneficiaries with a~     heart failure diagnosis. A secondary objective is to assess the impact of the Health E Heart~     Study on total system utilization costs.~   "
260353|NCT00141843|"~     The study will consist of two parts: a safety and efficacy period in which all subjects will~     participate and a pharmacokinetic analysis period, in which 30 eligible subjects will~     participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of~     ReFacto AF in patients with Hemophilia A.~   "
260354|NCT00141830|"~     The primary objective of this study is to compare the efficacy and safety of 3 dose levels of~     oral ERB-041 administered daily for 12 weeks versus placebo in subjects with active~     rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of~     methotrexate (MTX).~   "
260355|NCT00141817|"~     The purpose of this study is to characterize the PK profile, safety and tolerability of~     single and multiple doses of pantoprazole in children aged 1 through 11 years with~     endoscopically proven GERD.~   "
260356|NCT00141804|"~     To study the efficacy and safety of the administration of Tacrolimus in combination with~     Sirolimus for the prevention of acute rejection in patients after renal transplantation~   "
260357|NCT00141791|"~     The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg~     given twice weekly in subjects with moderate to severe persistent asthma.~   "
260358|NCT00141778|"~     Atrial fibrillation (AF) is the most prevalent, sustained type of irregular heartbeat and~     affects over 2 million Americans. Post-operative AF, which leads to significant morbidity and~     a prolonged hospital stay, complicates 20% to 40% of cardiopulmonary bypass (CPB) surgical~     procedures. While recent studies indicate that interruption of the~     renin-angiotensin-aldosterone system by either angiotensin-converting enzyme (ACE) inhibition~     or AT1 receptor antagonism decreases the incidence of AF following a heart attack or~     cardioversion (electric shock to the heart), its effect on the incidence of post-operative AF~     has not been throughly studied. Studies in both animals and humans suggest that~     inflammation-induced atrial remodeling plays an important role in the cause of AF. Recent~     studies also provide evidence that activation of the renin-angiotensin-aldosterone system~     induces inflammation, myocyte injury, proarrhythmic electrical remodeling, and fibrosis~     through aldosterone.~   "
260359|NCT00141765|"~     The purpose of this study is to determine whether very high dosages of chemotherapy will~     improve the chance of surviving cancer.~   "
260360|NCT00141752|"~     This research will assess the accuracy of the Toronto Bedside Swallowing Screening Test~     (TOR-BSST), a new dysphagia screening test for patients with stroke. The purpose of the~     TOR-BSST is to predict the presence of dysphagia in stroke patients across their continuum of~     care in a simple and efficient manner. This initial research will assess the accuracy of the~     TOR-BSST in the acute and rehabilitative settings using videofluoroscopy as the gold standard~     for comparison. The results from this research will also assess the stability of the TOR-BSST~     across nursing, its primary user, and generate an estimate for the prevalence of dysphagia in~     adult stroke patients in the acute and rehabilitative settings. Participants in this research~     will be 315 stroke patients from several teaching centres in Ontario, namely 105 acute~     patients from the University Health Network, Sunnybrook & Women's College Health Sciences~     Centre, and Hamilton General Hospital, and 210 patients in the rehabilitation setting from~     the Toronto Rehabilitation Institute and Parkwood Hospital, London. Both the TOR-BSST and~     videofluoroscopic assessment will be administered within 24 hours of each other and~     interpreted according to published preferred practice guidelines for dysphagia. This research~     will be the first to implement and assess a standardised method for screening for dysphagia~     in stroke patients across the continuum of stroke recovery.~   "
260361|NCT00141739|"~     This is a clinical trial to see if the addition of etanercept to standard preventative~     medicines helps in preventing two major complications of hematopoietic stem cell~     transplantation (HSCT): decrease the rate of acute graft-vs-host disease (GVHD) and the risk~     of death.~   "
260362|NCT00141726|"~     The purpose of this study is to determine the effectiveness of etanercept in the treatment of~     patients with sub-acute lung injury following a bone marrow transplant. This study will also~     examine the toxicity of treatment with etanercept as well as whether there is an improved~     quality of life in these patients.~   "
260363|NCT00141713|"~     Etanercept (Enbrel) will be added to standard therapy for acute Graft-versus-Host Disease to~     see if the effectiveness of standard therapy can be improved.~      Partial Funding Source- FDA OOPD~   "
260364|NCT00141700|"~     This study is being conducted to determine the safety, side effects, and response to a~     combination of an established high-dose chemotherapy regimen, stem cell support and Rituximab~     (which is a form of immunotherapy).~   "
260366|NCT00141674|"~     Donated red blood cells vary in how old they are, that is, how long they have been stored~     since being collected from donors. Blood that has been donated is stored for a maximum of 42~     days, after this time it is expired. That means that red blood cells that are given to~     patients as a blood transfusion can be anywhere from a few days old to 42 days old. The~     average age of blood that is given as a blood transfusion in this hospital is 21 days old.~      As stored blood gets older its ability to carry oxygen may be reduced. Whether or not this is~     important in patients with a brain injury is not currently known.~      The purpose of this study is to try and determine if fresh blood (less than 5 days old) is~     better than old blood (greater than 20 days old) in improving the supply of oxygen in~     patients who have suffered an injury to their brain.~   "
260367|NCT00141661|"~     A 10-week safety and tolerability study of a potential treatment for mild to moderate~     Alzheimer's disease.~   "
260368|NCT00141648|"~     This trial is intended to determine the results obtained when standard treatment for Non~     Hodgkin's lymphoma is applied to the disease in a rare subtype which arises in bone. Patients~     in the study undergo a detailed assessment, then treatment with chemotherapy and~     radiotherapy, followed by close monitoring.~   "
260369|NCT00141635|"~     Implementation and Evaluation of Implementation of Quality of Life Diagnostics and Therapy in~     Individual Patients with Breast Cancer. A prospective study including 170 patients, 5 clinics~     and 38 general practitioners as coordinating doctors for quality of life therapies.~     Correlational study including several comparisons such as patients and their doctors.~   "
260370|NCT00141622|"~     Heart disease and stroke, known as cardiovascular disease, are major causes of death in~     people with chronic kidney disease. Abnormalities of a metabolic pathway called the~     “L-arginine-nitric oxide” pathway are thought to be particularly important in these people,~     and previous research in animals has suggested that sodium (salt) affects part of this~     metabolic pathway. The purpose of our research is to study the effects of sodium intake on~     the “L-arginine-nitric oxide” pathway, and on blood vessel function, in patients with kidney~     disease.~   "
260371|NCT00141609|"~     High blood pressure (hypertension) affects up to 80% of all patients receiving haemodialysis~     for chronic kidney disease (CKD). High blood pressure is a major cause cardiovascular disease~     (i.e. strokes, heart attacks and heart failure) and, thereby, cardiovascular deaths in these~     patients.~      A significant cause of raised blood pressure in haemodialysis patients is thought to be due~     to retention of salt in the body. In healthy people the kidneys excrete salt but the kidneys~     of patients with CKD cannot do this, so salt has to be removed by dialysis. However dialysis~     cannot remove as much salt as is necessary, and so it accumulates. This fact has been~     recognized for many years, and health professionals caring for haemodialysis patients often~     stress the importance of restriction of dietary salt intake.~      However no research has looked in detail at the mechanisms by which salt raises blood~     pressure in haemodialysis patients. It is likely that salt directly affects thirst, causing~     patients to drink more and become overloaded with fluid. In addition, salt may have direct~     effects on the blood vessel wall, causing failure of adequate blood vessel relaxation. Both~     of these factors may raise blood pressure.~      We will conduct a carefully controlled crossover study looking at the effects of a modest~     reduction in salt intake on BP. During the course of the study, which will last eight weeks,~     patients will receive both a 5 gram per day and a 10 gram per day salt intake. We will look~     at how thirst, fluid intake, a number of markers of blood vessel function and blood pressure~     differ on these two salt intakes.~   "
260372|NCT00141596|"~     The optimal treatment of drug resistant (defined as BP> 140/85 despite three~     anti-hypertensive drugs including a diuretic) is not well defined. This study aims to test~     the hypothesis that resistant hypertension is caused by excessive expansion of extracellular~     fluid volume. A secondary objective is to study which of three different antihypertensive~     drugs would be most useful in drug resistant hypertension.~   "
260373|NCT00141583|"~     Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure~     lowering agents, the exact mechanisms by which these agents lower BP are still not fully~     understood. This study aims to compare the blood pressure and hormonal responses (plasma~     renin activity and aldosterone) to the ACE inhibitor enalapril and ARB candesartan in~     individuals with mild essential hypertension.~   "
260374|NCT00141570|"~     To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with~     esterified estrogens tablets~   "
260375|NCT00141557|"~     To determine whether treatment with ESTRATEST® Tablets is superior to treatment with~     esterified estrogens tablets~   "
260376|NCT00141544|"~     To determine whether treatment with ESTRATEST® Tablets is superior to treatment with~     esterified estrogens tablets~   "
260377|NCT00141531|"~     A non-randomized, open-label phase II study to explore the feasibility, time to recurrence,~     duration of response and safety of the adjuvant intravesical instillation of EOquin~     (apaziquone) in patients with high-risk superficial bladder tumors, and the response and~     duration of response in patients with carcinoma in situ of the bladder.~   "
260378|NCT00141518|"~     The primary objective of this study is to collect health economic data depicting the initial~     levels and natural progression over time of resource usage, Parkinson's disease (PD)-related~     costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients~     treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about~     one-third were Duodopa-naïve prior to the start of the study.~   "
260379|NCT00141505|"~     The study is to evaluate the effect of bifeprunox on the pharmacokinetics of valproate in~     subjects with Bipolar I Disorder after multiple dose administration.~   "
260380|NCT00141492|"~     This study is to investigate how well Androgel, when tested against placebo gel, helps to~     control blood sugar levels in males with type 2 diabetes who have low testosterone (the main~     male hormone) blood levels and are taking oral diabetic medicines alone or in combination~     with insulin.~   "
260381|NCT00141479|"~     The purpose of this study is to investigate a safe treatment interruption interval(s) for~     re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to~     10 weeks.~   "
260382|NCT00141466|"~     The purpose of this study is to compare two different strategies to implement a new method to~     identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness,~     costs and feasibility of both of the implementation strategies will be assessed.~   "
260391|NCT00141349|"~     To determine the onset of action, safety and toleration of different formulations and doses~     of UK-369,003 in patients with erectile dysfunction. Patients should have been previously~     treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is~     4 weeks.~   "
260392|NCT00141336|"~     To evaluate the long-term safety and tolerability of pregabalin in patients with partial~     seizures.~   "
260393|NCT00141323|"~     The purpose of the study is to determine the safety and effectiveness of 2 doses of the~     investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing~     new spinal fractures in women with osteoporosis.~   "
260394|NCT00141310|"~     To determine the efficacy and safety of sildenafil citrate in the treatment of established~     pre-eclampsia~   "
260395|NCT00141297|"~     PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a~     new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is~     the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.~   "
260396|NCT00141284|"~     The purpose of this study is to confirm the safety, efficacy and delineate the~     pharmacokinetic properties of nelfinavir in HIV/ Hepatitis C coinfected subjects with Child~     Pugh A compensated cirrhosis and or Hepatic fibrosis~   "
260397|NCT00141271|"~     This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in~     outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are~     required to undergo a washout period of at least 7 days of any prior med.~   "
260398|NCT00141258|"~     To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized~     dose schedule with dose adjustment based on clinical response and tolerability, compared to~     placebo in subjects with partial seizures~   "
260399|NCT00141245|"~     To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.~   "
260400|NCT00141232|"~     The AFORRD trial is asking three important questions:~      What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a~     fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart~     disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given~     with or without a statin? Are there simple techniques that can help people to take their~     tablets on a regular basis?~   "
260401|NCT00141219|"~     To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose~     adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with~     peripheral neuropathic pain.~   "
260402|NCT00141206|"~     The primary purpose of this study is to evaluate the safety and efficacy of varenicline given~     for a twelve week treatment period in comparison with placebo and Zyban for smoking~     cessation.~   "
260403|NCT00141193|"~     This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial~     to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the~     occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37~     (Year 3) of study drug administration.~   "
260404|NCT00141180|"~     To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine~     receptor-1 antagonist.~   "
260405|NCT00141167|"~     The primary purpose of this study is to evaluate the safety and efficacy of varenicline given~     for a twelve week treatment period in comparison with placebo for smoking cessation.~   "
260406|NCT00141154|"~     To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients~     with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.~   "
260407|NCT00141141|"~     The purpose of this study is to evaluate the efficacy of Atorvastin vs Simvastatin in~     decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment~     phase.~   "
260408|NCT00141128|"~     SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel~     methodology~   "
260409|NCT00141115|"~     The purpose of this study is to determine if levetiracetam is effective in treating alcohol~     dependence in patients with anxiety symptoms. The researchers hypothesize that individuals~     are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and~     sleep disturbance symptoms that accompany reduction in alcohol use.~   "
260410|NCT00141102|"~     To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole~     in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in~     high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.~   "
260411|NCT00141089|"~     Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of~     subgroup-selective 5-hydroxytryptamine (5-HT) agonists.~      The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in~     male patients with chronic constipation.~   "
260412|NCT00141076|"~     This study will compare the physiological effects of two isoenergetic, nutrient-controlled~     diets that differ in glycemic index. The diets will be studied in obese adults in a 10-day~     crossover feeding trial.~   "
260413|NCT00141063|"~     The purpose of this study is to compare the safety and efficacy of two doses of~     dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD~     (MPH) and placebo in children ages 6-12 diagnosed with ADHD.~   "
260414|NCT00141050|"~     The purpose of this study is to compare the safety and efficacy of two doses of~     dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD~     (MPH) and placebo in children ages 6-12 diagnosed with ADHD.~   "
260415|NCT00141037|"~     Over the last 40 years, corticosteroids (steroids) have been an important part of drug~     regimens used to prevent organ rejection and to maintain the immune health of individuals who~     have received organ transplants. Unfortunately, the negative physical effects of steroids can~     be severe, especially in children. The purpose of this study is to determine the safety and~     effectiveness of a steroid-free treatment regimen for children and adolescents who have~     received kidney (renal) transplants.~   "
260416|NCT00141024|"~     The purpose of the study is to determine the safety of and immune response to the~     investigational HIV vaccine, EP HIV-1090, in HIV uninfected adults.~   "
260417|NCT00141011|"~     The primary purpose of this study is to determine whether a brief intravenous infusion of~     ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.~   "
260418|NCT00140998|"~     The study attempts to evaluate if the way of administering estrogen, the principal female~     hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome.~     These are girls who are very short and whose ovaries do not work. We will examine changes~     bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough~     the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH~     therapy.~   "
260419|NCT00140985|"~     Antiproteinuric Efficacy of Losartan Potassium in Patients with Non-Diabetic Proteinuric~     Renal Diseases.~   "
260420|NCT00140972|"~     A Study to Assess Etoricoxib versus Diclofenac in Chinese Patients with Osteoarthritis of the~     Knee or Hip~   "
260421|NCT00140959|"~     A study to evaluate the effects of combination losartan versus combination atenolol in~     patients with ambulatory systolic hypertension.~   "
260422|NCT00140946|"~     A study to assess the clinical effect of montelukast sodium with concomitant administration~     of inhaled budesonide in asthmatic patients.~   "
260423|NCT00140933|"~     Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or~     placebo or diclofenac and fill out a patient diary on daytime pain severity during daily~     activities, night pain severity, and acetaminophen/paracetamol intake.~   "
260424|NCT00140920|"~     A study to compare pre-operative administration of rofecoxib versus post-operative~     administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative~     pain after total knee joint replacement in patients with osteoarthritis of the knee.~   "
260425|NCT00140907|"~     To demonstrate that losartan (+ conventional therapy) compared to placebo (+ conventional~     therapy) will reduce the number of RT patients who experience histological lesions of chronic~     allograft nephropathy~   "
260426|NCT00140894|"~     A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in~     patients with Familial Adenomatous Polyposis.~   "
260427|NCT00140881|"~     A 53-week study to determine the effect of montelukast sodium when given to children (with~     infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.~   "
260428|NCT00140868|"~     The purpose of this study is to assess quality of life and bowel symptoms after treatment.The~     main objective is to compare the effect on quality of life of minimally invasive bowel~     surgery and endoscopic stent placement in the treatment of malignant large bowel obstruction.~   "
260429|NCT00140855|"~     The purpose of this study is to determine whether immune therapy with anti-CTLA4 antibody is~     effective in people with advanced synovial sarcoma.~   "
260430|NCT00140842|"~     This study will examine hormonal differences in ghrelin and growth hormone in obese and~     normal weight adolescents and their relationship to body composition and insulin resistance.~     The study will also investigate the effect of the macronutrient composition of a meal on~     postprandial ghrelin levels and whether ghrelin responses will predict the degree of hunger~     and caloric intake at a subsequent meal.~   "
260431|NCT00140829|"~     Cerebellar ataxias (CA) and spastic paraplegias (SP) are genetically and clinically very~     heterogeneous. More than 40 loci are already known but the number of phenotypes is even~     greater suggesting further genetic heterogeneity. These progressive disorders are often~     severe and fatal, due to the absence of specific therapy. The SPATAX network combines the~     experience of European clinicians and scientists working on these groups of diseases. Over~     the past year, they have assembled the largest collection of families and achieved a number~     of tasks (initiation of a clinical and genetic database, distribution of DNA to participating~     laboratories, mapping of three new loci, and refinement of several loci). In addition to~     clinicians from Europe and Mediterranean countries, who play a major role in collecting~     families according to evaluation tools developed and validated by the SPATAX members, the~     group includes major European laboratories devoted to the elucidation of the molecular basis~     of these disorders. Each laboratory will centralize all families with a subtype of autosomal~     recessive (AR) CA (n=116) or SP (n=207) in order to efficiently map and identify the~     responsible gene(s). Genome-wide scans are already underway in 61 families. Given the~     expertise of the participants, the researchers expect to map and identify several genes~     during the course of this project. The spectrum of mutations and phenotype/genotype~     correlations will be analysed thanks to this unique series of patients with various~     phenotypes. The knowledge gained will be immediately applicable to patients in terms of~     improved positive diagnosis, follow-up and appropriate genetic counselling. In the long term,~     models for genetic entity will be developed in order to understand the pathophysiology and to~     identify new targets for treatment. The series of patients assembled and the precise~     knowledge of natural history will facilitate the implantation of therapeutic trials based on~     rational approaches.~   "
260432|NCT00140816|"~     Foods containing more dairy fat (and thus a higher proportion of short and medium chain fatty~     acids and possibly some other nutrients or micronutrients with effect on energy intake,~     satiety or energy metabolism) affect energy balance and metabolic profile in subjects prone~     to develop abdominal adiposity and metabolic syndrome.~      The aim of the study is to test the hypothesis that intake of dairy products has a favorable~     effect on markers of the metabolic syndrome.~      To explore such a hypothesis the participants have to be in a free living situation during an~     extended study period.~   "
260433|NCT00140803|"~     To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone~     will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared~     with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult~     subfoveal and minimally classic subfoveal CNV secondary to AMD. The intravitreal~     triamcinolone will be given as either a 1 mg or 4 mg dose. This study will also evaluate the~     safety of Visudyne therapy in combination with intravitreal triamcinolone. An interim~     statistical readout will be performed when the first 60 patients have completed 6 months of~     follow-up evaluation.~   "
260434|NCT00140790|"~     The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan~     160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to~     40 mg/day in patients with moderate renal dysfunction.~   "
260435|NCT00140764|"~     The purpose of this intervention is to find out whether intravaginal treatment with a gel~     containing an antibiotic (metronidazole), compared to a similar placebo gel (without~     antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection~     among African women who are HIV uninfected or HIV infected. The study will also determine the~     effect of these vaginal gels on genitourinary symptoms.~   "
260436|NCT00140751|"~     The purpose of this study is to compare the efficacy and tolerance of a treatment~     simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment~     in HIV-infected patients~   "
260437|NCT00140738|"~     Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule~     that will last for up to about a year, and thereafter there will be a follow-up period of~     about one more year.~   "
260438|NCT00140725|"~     This is a single-centre prospective randomised study comparing the virological and~     histological response of HBV infection to lamivudine in combination with interferon versus~     lamivudine alone.~   "
260439|NCT00140712|"~     This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients~     with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole~     titration regimen for this age group. Patients will receive two single doses unless poor~     tolerability is observed following the first dose.~   "
260440|NCT00140699|"~     Balance disorders in children are poorly known, underestimated, and rarely assessed.~     Technologies to assess balance in children are almost non-existent, apart from a few~     exceptions. Such technologies are routinely used in adults for some decades, and are of~     considerable contribution in the diagnosis and treatment of adults balance disorders.~      The aim of this study is :~        1. to assess objectively children balance disorders.~        2. to provide technologies suitable for children balance assessement.~        3. to study children balance disorders suffering from sensorineural hearing loss.~   "
260441|NCT00140686|"~     The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV)~     gastroenteritis (GE) during the first efficacy period.~   "
260442|NCT00140673|"~     The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine~     efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2~     weeks after Dose 2 until one year of age. 2) In all subjects (N = 60 000), to determine the~     safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within~     31 days (Day 0-Day 30) after each HRV vaccine dose.~   "
260443|NCT00140660|"~     This study is a multicentric randomized trial evaluating the efficacy of the combination~     R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.~   "
260444|NCT00140647|"~     The purpose of this study is to determine if ramipril and/or rosiglitazone retard the~     progression of atherosclerosis as evaluated by serial carotid intermedial thickness~     measurements.~   "
260445|NCT00140634|"~     The objectives of the Cartilage Repair Registry is to report the long term efficacy and~     safety of cartilage repair procedures in Registry patients.~   "
260446|NCT00140621|"~     This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and~     safety of agalsidase beta (Fabrazyme [recombinant form]) administered by intravenous drip~     infusion in participants with cardiac Fabry disease.~      Participants participated for 4 weeks or less in the baseline period and 156 weeks for the~     treatment period.~   "
260447|NCT00140608|"~     The purpose of this study is to investigate if the space occupying effect of Seprapack will~     lead to a reduction in post operative adhesions and more healing of the sinus cavity when~     compared to the use of no packing material.~   "
260448|NCT00140595|"~     This study is a multicentric randomized trial evaluating the efficacy of the combination~     ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59~     years with diffuse large B-cell lymphoma and one factor of the age-adjusted international~     prognostic index (IPI).~   "
260449|NCT00140582|"~     -  Objectives~             -  Primary objective: To evaluate in patients with advanced follicular lymphoma the~               benefit of maintenance therapy with rituximab after induction of response with~               chemotherapy plus rituximab in comparison with no maintenance therapy~             -  Secondary objective: To evaluate response rates, event driven survival endpoints~               (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined~               with rituximab, with or without maintenance with rituximab, for first line~               treatment of advanced stage follicular lymphoma.~        -  Study Design This is an international open-label, multicentre, randomized study with two~          treatment phases. In the induction phase patients have to respond to 1st line induction~          treatment in order to be eligible for randomization to the second phase of maintenance~          treatment or observation. After the maintenance period patients will be included in the~          follow up phase for 3 years.~   "
260450|NCT00140569|"~     2 parallel studies.~        -  For young patients (18-60 years): randomization between CHVP + interferon for 18 months~          and 4 CHOP followed by autotransplant after TBI~        -  For elderly patients (>60 years): randomization between CHVP + interferon for 18 months~          and fludarabine 5 days every months for 6 months~   "
260451|NCT00140556|"~     Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative~     intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia~     and high levels of angiogenesis (blood vessel formation) are associated with treatment~     failure. Preclinical models reveal that radiotherapy itself may induce tumor secretion of~     vascular endothelial growth factor (VEGF). Curability may consequently be reduced by multiple~     mechanisms. Over-expression of epidermal growth factor receptor (EGFR) also occurs commonly~     and increases the risk of treatment failure. The addition of EGFR blockade to RT alone~     increases the chance of a cure. Concurrent VEGF and EGFR blockade could be synergistic with~     one another and improve the effectiveness of concurrent chemoradiation for advanced head and~     neck cancer.~      This study will add angiogenic and epidermal growth factor receptor (EGFR) blockade into an~     established program of curative intent concurrent chemoradiation for locally advanced head~     and neck cancer. The safety and effectiveness of delivering the drugs bevacizumab and Tarceva~     in conjunction with twice daily irradiation and concurrent cisplatin (CDDP) chemotherapy will~     be determined.~   "
260452|NCT00140543|"~     1. To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based~          immunosuppression (in conjunction with initial short-term steroids and polyclonal~          antibody administration) in Type 1-diabetic patients undergoing simultaneous~          pancreas/kidney allograft transplantation.~        2. To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related~          complications and overimmunosuppression-associated complications, particularly under~          monitoring of the pharmacokinetic profile of all drugs administered.~   "
260453|NCT00140530|"~     The purpose of this study is to assess the efficacy of nonpolymer-based rapamycin-eluting~     stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of~     coronary arteries.~   "
260468|NCT00140335|"~     The purpose of this study is to determine the effects of a commercial hand washing promotion~     program on hygiene knowledge, attitudes, and practices, and on health outcomes such as~     reported infectious illnesses and school absences.~   "
260454|NCT00140517|"~     Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP)~     continue to spread, impeding control of this important disease. CQ and SP are still the most~     commonly used antimalarial drugs for malaria prevention during pregnancy and might be made~     less effective by resistance. However, the treatment and prophylaxis regimens used may also~     create conditions for selecting resistant malaria parasite strains. A better understanding of~     the relationships between chemoprophylaxis regimens and resistance would be helpful to~     improve chemoprophylaxis of malaria in pregnancy.~      This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether~     there is a relationship between the use of standard prophylactic regimens with CQ and SP and~     the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2~     parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: -~     weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment~     given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent~     presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These~     treatment groups will also be compared to a group of women delivering at the same health~     centre but who have not been participating in the study. The second part will be a clinical~     trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in~     pregnant women presenting with uncomplicated malaria attacks.~      The study will be conducted from October 2002 to March 2005 in a health centre of~     Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP~     is low.~   "
260455|NCT00140504|"~     This is a study to better understand the nature and extent of adverse drug events (ADEs),~     defined as injuries due to prescription medications, in primary care. We will study whether~     PatientSite (an internet-based communication program for patients and health care providers)~     can improve clinicians' ability to detect adverse drug events among primary care patients and~     to mitigate the consequences by sending electronic queries to patients after they receive new~     medication prescriptions.~   "
260456|NCT00140491|"~     The goal of this pilot study is to evaluate the effect of Vision Restoration Therapy, VRT, on~     the visual function of patients with unilateral or bilateral AION, who have good central~     vision (at least 20/60) and altitudinal visual field defects.~   "
260457|NCT00140478|"~     The purpose of this study is to determine the effects (good and bad) that mifepristone has on~     patients with androgen independent prostate cancer.~   "
260458|NCT00140465|"~     The purpose of the study is to test whether an increase of the maintenance dose of~     clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced~     platelet aggregation~   "
260459|NCT00140452|"~     The use of Thalidomide in patients with ALS who have disease progression.~   "
260460|NCT00140439|"~     Little is known about how ED-based programs can help to reduce pediatric ED visits for~     asthma. The current study evaluated a novel intervention in which the ED itself became the~     site of highly individualized, comprehensive follow-up asthma care. It sought to determine if~     such an intervention could decrease subsequent unscheduled visits for asthma while improving~     asthma quality of life.~   "
260461|NCT00140426|"~     The aim of this pilot study is to determine the safety and efficacy of risperidone for the~     treatment of anorexia nervosa.~      Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image~     distortion and Eating Disorder Inventory -2 scores than subjects on placebo.~      Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body~     weight sooner than controls.~   "
260462|NCT00140413|"~     Hypotheses:~        1. The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular,~          among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is~          commonly thought.~        2. Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes.~      Aims:~        1. Determine the prevalence and types of endocrinopathies in children diagnosed with ONH.~        2. Correlate endocrine outcome with radiographic, ocular, and developmental findings in~          children with ONH.~        3. Examine the effect of GH treatment on growth and obesity in children with ONH,~          GH-deficiency, and either subnormal or normal growth compared to children with ONH that~          are not GH-deficient.~        4. Compare growth outcomes between children with isolated GH-deficiency and those with~          multiple hormone deficiencies.~   "
260463|NCT00140400|"~     The objective of this study is to evaluate the safety and efficacy of a prime-boost dose~     schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine~     (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and~     tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease~     progression as well as local and systemic immune responses to the vaccine.~   "
260464|NCT00140387|"~     The objective of this study is to evaluate the safety and efficacy of priming vaccinations,~     and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate~     Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and~     laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the~     antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and~     antitumor responses will be quantitated.~   "
260465|NCT00140374|"~     The objective of this study is to evaluate the safety and efficacy of priming vaccinations,~     and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical~     observations and laboratory measurements will be monitored to evaluate safety and toxicity.~     Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels,~     will be evaluated and antitumor responses will be quantitated.~   "
260466|NCT00140361|"~     This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which~     is the current national treatment of choice for uncomplicated malaria in Tanzania, and a~     combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.~      Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified~     first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited~     basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether~     treated bednets would reduce confounding by reinfection~   "
260467|NCT00140348|"~     The purpose of this study is to evaluate clinical and laboratory safety in patients receiving~     4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated~     dose.~   "
260469|NCT00140322|"~     A randomized controlled trial to assess the effectiveness of an at-home comprehensive~     approach to preventing falls among adults 65 years and older at high risk for falls.~   "
260470|NCT00140309|"~     This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin~     vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks~     of daily therapy) during the first two months of standard treatment (with isoniazid,~     rifampin, and pyrazinamide) for sputum smear-positive pulmonary tuberculosis.~   "
260471|NCT00140296|"~     Consistent and correct use of an effective contraceptive method is a primary determinant in~     preventing pregnancy. Unfortunately, only a minority of healthcare providers adequately~     address women’s contraceptive needs. We have developed a standardized behavioral-based~     contraceptive counseling model that can be used by providers and other clinic staff to~     address this limitation. The model, ESP, is an adaptation of motivational interviewing and~     involves: Exploring discrepancies between pregnancy intention and contraceptive use and~     between risk of STDs and condom use; Sharing information; and Promoting behaviors to reduce~     risk.~      Study question: Does ESP counseling lead to an increase in consistency and effectiveness of~     contraceptive use among women at risk of unintended pregnancy?~      Methods: Randomized controlled trial of 747 women, ages 16-44, at self-identified risk of~     unintended pregnancy enrolled from March 2003 to September 2004 at healthcare settings in~     North Carolina. Intervention participants received individualized ESP counseling from a~     health educator to address barriers to effective and consistent contraceptive use. Risk~     reduction steps were negotiated. Pregnancy, Chlamydia infection and contraceptive use were~     assessed at baseline and follow-up. “Highly effective” contraceptive use was defined as a~     combination of effectiveness and consistency. Women in the control arm received general~     preventive health counseling (e.g., smoking and exercise). Differences between the study arms~     at 12-months may illustrate the longer term influence of the intervention.~   "
260472|NCT00140283|"~     There is a great variability in the different primary care teams referral rate. And~     variability means inappropriateness somewhere in the process of care. The most important~     determinants of the variability are the attitude and knowledge of the professional, the~     existence and availability of evidence, the resources available and the professionals~     practice style. To improve the knowledge of the professionals could be a way to decrease the~     variability. Because of this, we have the aim to determinate the effectiveness of an~     educational intervention to improve the primary care teams from the city of Barcelona~     referral rate.~   "
260473|NCT00140270|"~     This research study involves implementing and evaluating a physical training program~     specifically designed to reduce the risk of ligamentous knee injuries in female soccer~     players by incorporating proven neuromuscular and proprioceptive training concepts into a~     concise, on-field warm-up activity. All 283 Division I NCAA women’s soccer teams were asked~     to participate in this research study. Those that agreed were randomized to control (usual~     training program) and intervention (alternative warm-up program). Both groups of teams~     provided investigators with participation and knee injury information during the 15 week 2002~     fall soccer season. Requested information included only that which would be readily available~     to the certified athletic trainers (ATC) in their normal course of duties. The knee injury~     rates among intervention team athletes were compared with control team athletes to determine~     program effectiveness. Data collection is complete and the report should be submitted shortly~     for publication.~   "
260474|NCT00140257|"~     Objective: To evaluate the efficacy of preventive treatment with a selective serotonin~     reuptake inhibitor (SSRI) (escitalopram) in the first year after acute coronary syndromes~     (ACS).~      Methods: 240 patients with acute coronary syndromes (ST-elevation myocardial infarction~     [STEMI]), non-STEMI or unstable angina) will be enrolled within 8 weeks after ACS and will be~     randomly assigned to treatment with escitalopram/placebo (5-20 mg) in 52 weeks. Primary~     outcome measures are the diagnosis of depression and HDS (Hamilton Depression Scale).~     Psychiatric measurements: SCAN (Schedules for Clinical Assessment in Neuropsychiatry), HDS,~     HAS (Hamilton Anxiety Rating Scale), Udvalg for Kliniske Undersogelser (UKU) Side Effect~     Rating Scale, ESSI (Enhancing Recovery in Coronary Heart Disease [ENRICHD] Social Support~     Instrument), SF-36 (Short Form-36 Health Survey), SCL-92 (Symptom Check List) and BDI (Beck´s~     Depression Inventory). Cardiological measurements are blood pressure, electrocardiography,~     echocardiography (left ventricular ejection fraction), heart rate variability and use of~     medicine.~      Discussion: ACS patients with mental illness are usually only diagnosed to a very small~     extent during admission in a cardiologic department. These patients mainly remain untreated~     with an increased risk of somatic comorbidity and mortality. Therefore, it is in accordance~     with ethical principles to conduct a double blind, placebo-controlled study investigating the~     interface between anxiety, depression and ACS. Even in this blinded study, where one of the~     groups are treated with placebo, there will be a higher degree of treatment of depressive~     symptoms due to the low recognition of this problem.~      Conclusion: The DECARD study is the first study evaluating the effect of prophylactic~     treatment of depression in patients with ACS. The study will show if prophylactic treatment~     will improve cardiac prognosis.~   "
260475|NCT00140244|"~     The purpose of this study is to examine whether replacing leptin to normal levels can reverse~     the changes in fat distribution, lipid profile, and other metabolic problems associated with~     highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in~     HIV patients.~   "
260476|NCT00140231|"~     The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a~     person when he or she is fasting will reverse changes in metabolism, and hormone levels, and~     immune function associated with fasting, which decreases leptin levels.~   "
260477|NCT00140218|"~     The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter~     the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients~     at an early stage of disease will be observed for 3 months after enrollment and then treated~     with drug for 6 months.~   "
260478|NCT00140205|"~     The purpose of this study will be to determine the correct dose of leptin, a natural hormone~     secreted by the fat cells, to give to people when they are fasting and also to determine~     whether giving leptin to a person when he or she is fasting will reverse the changes in~     hormone levels that occur with fasting.~   "
260485|NCT00140101|"~     The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx~     drug-eluting stent in patients with blockage of native coronary arteries. The study is~     designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that~     has proven superior to bare metal stents and is a recognized standard of care.~   "
260503|NCT00139867|"~     The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa~     Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets,~     in subjects with stable Parkinson's disease.~   "
260479|NCT00140192|"~     Creatine plays a pivotal role in brain energy homeostasis. Creatine supplementation is widely~     used in enhancing sports performance, and has been tried in the treatment of neurological,~     neuromuscular and atherosclerotic disease with a paucity of side effects.~      Dechent et al (1999) studied the effect of oral creatine supplementation for 4 wk~     demonstrating a statistically significant increase of mean concentration of total creatine~     across brain regions. These findings suggest the possibility of using oral creatine~     supplementation to modify brain high-energy phosphate metabolism in subjects with various~     brain disorders, including schizophrenia and major depression. Recently, Rae et al (2003)~     reported that creatine supplementation for 6 weeks had a significant positive effect on both~     working memory and Raven matrices. Several independent lines of evidence suggest the possible~     involvement of altered cerebral energy metabolism in schizophrenia.~      We are performing a double blind cross-over study of creatine in schizophrenia.~      Forty patients will be treated with creatine for 3 months in a double-blind crossover design.~     Rating scales will include scales for assessing negative and positive symptoms of~     schizophrenia, clinical global impressions scale, scales for side-effects and a cognitive~     battery~      Creatine effects on brain energy metabolism and its possible cognitive enhancing properties~     raise the possibility of developing a new therapeutic strategy in schizophrenia focusing on~     treating metabolic hypoactive brain areas including frontal regions.~   "
260480|NCT00140179|"~     Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its~     well-known teratogenicity limits its use in young women of childbearing age. According to~     toxicologic studies the teratogenicity of valproate stems from its free carboxylic group.~     Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does~     not undergo a biotransformation to the corresponding free acid. It is also likely or at least~     possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be~     distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only~     1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice).~      The investigators are performing a double-blind controlled trial of valnoctamide as an~     anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate~     substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly~     admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and~     Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or~     schizoaffective disorder, manic type. Patients admitted to the study are treated with~     risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2.~     Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and~     increased to 1200 mg (400 mg three times daily) after four days.~      Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief~     Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global~     Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas~     chromatography. Each patient receives valnoctamide or placebo for 5 weeks.~      Low teratogenic mood stabilizers are a high priority for current research.~   "
260481|NCT00140166|"~     Controlled studies using the orthomolecular approach have been few (Deutsch, Ananth, & Ban,~     1977). Those that were done were performed in chronic schizophrenia or in populations that~     included bipolar and schizoaffective patients. Both of these diagnostic groups are not today~     considered to benefit from the orthomolecular approach. Moreover, some negative studies of~     high-dose niacin were done in patients who were not otherwise given general counseling for~     good diet as described above. Therefore, this proposal is to study in a controlled manner~     carefully defined first onset schizophrenic patients using the protocol advocated by Osmond~     and Hoffer (1962). Patients can enter the study if they have been ill less than 1 year and~     are in their first hospitalization.~   "
260482|NCT00140153|"~     The success of sildenafil in the treatment of erectile dysfunction has led to efforts to find~     similar treatments for prevalent disorders of female sexual dysfunction. Daily transdermal~     testosterone has been shown to improve sexual function in women after oophorectomy (Shifren~     et al, Transdermal testosterone treatment in women with impaired sexual function after~     oophorectomy, New England Journal of Medicine, 343; 682-8, 2000). In laboratory measures of~     sexual arousal, a single application of transdermal testosterone enhanced vaginal blood and~     increased erotic fantasy in normal volunteer women in the laboratory setting, four hours~     after application (Tuiten et al, Can sublingual testosterone increase subjective and~     physiological measures of laboratory-induced sexual arousal?, Arch Gen Psychiatry,~     59;465,2002). We therefore planned a study of transdermal testosterone (25mg) marketed as~     Androgel in female hypoactive sexual desire disorder. Patients are recruited from the~     sexology clinics at Soroka Hospital and the Beersheva Mental Health Center. They are~     randomized to Androgel or placebo and given 10 packets and instructed on application to the~     abdomen and shoulders, four hours before planned intercourse. Patients unable to discuss~     planned intercourse with their partner are offered psychosexual counseling and those still~     unable after three sessions are excluded. After one month patients on active Androgel are~     crossed over to placebo or vice versa. Patients self-rate sexual response after each~     intercourse using the Brief Index of Sexual Functioning for Women, and Arizona Sexual~     Experiences Scale (ASEX)-Female and are rated in interview at the end of each month of~     treatment using the Sexual Function Questionnaire (SFQ-V1). Our prn technique avoids the~     androgenizing side effects of continuous daily treatment.~   "
260483|NCT00140140|"~     The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and~     vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor~     support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive~     disease may receive Herceptin, and 2) determine the optimal tolerated dose of ABI-007 and~     vinorelbine, given concurrently on a weekly basis, in the presence of planned growth factor~     support with G-CSF.~   "
260484|NCT00140114|"~     Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the~     United States since 1988 as a gastric cytoprotective agent. In contradistinction to~     prostaglandin E2 preparations (dinoprostone, Prepidil, Cervidil), misoprostol is inexpensive~     and available in scored tablets that can be broken and inserted vaginally. Despite a focused~     campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over~     the past several years, gained widespread acceptance as both a labor induction and a cervical~     ripening agent. Such off-label indication has been endorsed by the American College of~     Obstetricians and Gynecologists and other medical bodies. Recently, FDA approved a new label~     for the use of cytotec during pregnancy which removed pregnancy as a contraindication for its~     use. Vaginal administration seems to be more efficacious than when given orally, although~     there is the worry of uterine tachysystole and hyperstimulation with vaginal doses > 50-µg.~     The use of sublingual misoprostol for cervical ripening at term was recently investigated in~     two studies that compared it to the oral route, on the assumption that the sublingual route~     would have the higher efficacy of the vaginal route by avoiding the first pass effects of the~     gastrointestinal and hepatic systems, while having lower hyperstimulation rates by avoiding~     the direct effects on the cervix. In addition, the sublingual route would combine an easier~     administration with the added advantage of no restriction of mobility after administration.~     There has been no previous report in the literature comparing the use of misoprostol given~     sublingually to that given vaginally for the induction of labor at term. Our aim is to~     compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the~     current standard) to that given sublingually.~   "
260486|NCT00140088|"~     Minor needlestick procedures often cause significant pain and distress in pediatric patients~     yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use,~     prefilled, needle-free product that immediately delivers powdered lidocaine into the~     epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III,~     prospective, randomized, double-blind, placebo-controlled study is to investigate the~     efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3~     to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial~     will enroll approximate 504 evaluable subjects at centers located in the US.~   "
260487|NCT00140075|"~     The purpose of this study is to compare two combinations of drugs, epirubicin given with a~     taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to~     see if one of the combinations is better at preventing or delaying the time for breast cancer~     recurrence and death after 3 years. The study will also evaluate the side effects of both~     treatment combinations.~   "
260488|NCT00140062|"~     The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with~     that of usual care over 36 months. Safety and health care utilization will be evaluated.~   "
260489|NCT00140049|"~     To demonstrate the statistical non inferiority of the combination of latanoprost and timolol~     given in the evening time once a day vs the combination of dorzamalide and timolol twice a~     day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week~     treatment.~   "
260490|NCT00140036|"~     This protocol describes procedures for the collection of blood samples for the intent of~     determining genetic contribution to the safety and efficacy of CPT/FU/LV.~   "
260491|NCT00140023|"~     The study will assess the clinical efficacy at Day 14-21 (Test of Cure), 14-21 days after~     starting the study drug; those subjects from whom a baseline pathogen is identified will also~     be assessed for bacteriologic response. All subjects who receive 1 dose of study medication~     will be assessed for safety.~   "
260492|NCT00140010|"~     ABSTRACT:~      Delayed ischemic deficits (DID) and strokes caused by low cerebral blood flow (CBF) are major~     sources of poor outcome following aneurysmal subarachnoid hemorrhage (SAH). DID are often~     accompanied by vasospasm and abnormalities in cerebrovascular autoregulation, an important~     reflex involved in the defense against low CBF. Assessment of vasospasm and impaired~     autoregulation can be conveniently measured non-invasively by use of transcranial Doppler~     (TCD) and the transient hyperaemic response test (THRT). Vasospasm and abnormalities in the~     THRT can predict those patients who are at risk of developing DID. In this study, the~     investigators wish to explore the neuroprotective and angiogenic effects of systemic~     erythropoietin (EPO) therapy on vasospasm and autoregulation following SAH, and examine~     whether any improvements translate into reduced incidences of DID and poor outcome. Eighty~     patients with SAH will be recruited over one year to receive three doses in the first week of~     either intravenous epoetin beta 30000 IU or placebo (0.9% saline) 50 ml/30 min as part of a~     randomized, double-blind, placebo-controlled trial. The investigators propose daily TCD~     assessment for detecting vasospasm and abnormal autoregulation. Outcome measures will examine~     the influence of EPO therapy on the incidence, severity, and duration of vasospasm, abnormal~     autoregulation, and DID.~      PURPOSE:~      This study is a randomized, double-blind, placebo-controlled clinical trial investigating the~     potentially beneficial effects of systemic recombinant human erythropoietin therapy (Epoetin~     beta, NeoRecormon®, Roche, 30000IU/50 ml/30 min, three times in the first week) on cerebral~     autoregulation and incidence of delayed ischemic deficits (DID) following aneurysmal~     subarachnoid haemorrhage (SAH).~      HYPOTHESIS Systemic recombinant human erythropoietin therapy can be used safely following SAH~     to ameliorate vasospasm, improve cerebral autoregulation, reduce DID, and facilitate~     neurological recovery.~   "
260493|NCT00139997|"~     The purpose is to study treatments of Seasonal Affective Disorder (SAD).~   "
260494|NCT00139984|"~     The purpose of this study is to determine whether in patients with arterial hypertension,~     treatment guidance using 24-hour blood pressure measurement results in better blood pressure~     control compared to treatment guidance using office blood pressure measurement.~   "
260495|NCT00139971|"~     To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative~     adjuvant chemotherapy for completely resected non-small cell lung cancer.~   "
260496|NCT00139958|"~     Objectives: Evaluate differences for mortality, morbidity and the cardiovascular risk factors~     between HIV and non-HIV patients with an acute coronary syndromes (ACS) after a 3-years~     follow up.~   "
260497|NCT00139945|"~     In growth hormone deficient patients: Determination of endogenous circulating ghrelin levels,~     ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction~     in fat and muscle.~   "
260498|NCT00139932|"~     This study is being conducted to determine if the co-administration of formoterol fumarate~     and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients~     with COPD.~   "
260499|NCT00139919|"~     This study is to assess the tolerability of bifeprunox with the progressive elimination of~     titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in~     either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an~     optional open-label 26-week extension study.~   "
260500|NCT00139906|"~     This study is to assess the safety and tolerability of a five-day titration schedule (using~     twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg~     daily. The study duration is two months.~   "
260501|NCT00139893|"~     To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is~     metabolized faster than the conventional Reglan tablet in patients with diabetic~     gastroparesis, pharmacokinetics following a single 10 mg dose of each formulation are being~     compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented~     gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each~     dosing. Exclusion criteria include serum glucose >300 mg/dL, Hb1Ac >10%, and concurrent~     illness interfering with gastrointestinal motility. Subjects will stay in the clinic~     overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning~     dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve~     (AUC) from time zero to 8 hr will be compared for the 2 formulations.~   "
260502|NCT00139880|"~     To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a~     faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single~     dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease.~     Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are~     eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both~     treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or~     conventional) are administered. The dose is the same as the subject's prestudy regimen. The~     primary efficacy variable, time to onset of action, is the first postdose time when a 30%~     decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by~     a rater blinded to the active treatment received by the subject.~   "
260504|NCT00139854|"~     This was a multicenter, open-label, randomized crossover trial comparing two treatments,~     Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking~     conventional immediate-release alprazolam tablets for anxiety. The trial included five study~     visits (four periods of 7 3 -day duration): Screening (Visit 1), Treatment Period 1 (Visit~     2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5 [telephone~     visit]). At Visit 1, following screening, eligible subjects continued to take their own~     conventional alprazolam as prescribed by their physician. At Visit 2, eligible subjects were~     randomized in approximately equal numbers to one of two treatment sequences: Alprazolam ODT/~     conventional alprazolam or conventional alprazolam/ Alprazolam ODT. Subjects continued taking~     alprazolam in accordance with the treatment sequence to which they were assigned, at the same~     dose regimen as their own prescribed alprazolam. At Visit 3, subjects crossed over to the~     alternate treatment until Visit 4. At Visit 4, subjects completed the Subject Preference~     Questionnaire, and a physical examination and clinical laboratory tests were performed. At~     the end of Visit 4, subjects resumed taking their own conventional alprazolam. The site made~     a follow-up telephone call 7 - 3 days after Visit 4 to assess the subject's health status.~   "
260505|NCT00139841|"~     SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of~     Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent~     Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab~     (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every~     21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive~     disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6~     cycles may receive an additional 2 cycles. Following the end of treatment, patients will be~     followed for up to 2 years until disease progression or start of another anti-cancer therapy.~   "
260506|NCT00139828|"~     In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is~     evaluated in previous treated and untreated patients with severe, moderate or mild~     haemophilia B.~   "
260507|NCT00139815|"~     Study Objectives~      PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior~     to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in~     the acute treatment of patients with unstable angina/non ST-segment elevation myocardial~     infarction concurrently managed with standard medical therapy.~      SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical~     analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated~     statistically.~        -  To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at~          Day 9~        -  To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding~          events up to Day 9~        -  To determine whether the relative effect on the primary end point of fondaparinux versus~          enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180~      Study Drug: Patients will be randomized to receive either:~        -  Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or~        -  Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection~      Duration of Therapy:~        -  Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)~        -  Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.~        -  Patients should receive an ASA and all other standard medical therapies.~      Substudy:~        -  A substudy comparing routine early coronary angiography immediately or as soon as~          possible (but no later than 24 hours after randomization) and intervention versus~          delayed (>48 hrs) coronary angiography and intervention.~      Primary Outcome: The first occurence of any component of the following composite up to Day 9:~        -  Death~        -  Myocardial Infarction~        -  Refractory Ischemia~   "
260508|NCT00139802|"~     The purpose of the study was to evaluate procedural and late outcome of coronary artery~     stenting using 2 different unmounted stents~   "
260509|NCT00139789|"~     This was a multicenter, open-label, randomized, crossover trial in subjects with MS who were~     already taking a stable dose of baclofen (up to 80 mg/day) for spasticity. The trial was~     designed to assess subject preference for Kemstro or conventional baclofen. At Visit 1,~     subjects were screened, and if qualified, were randomly assigned to one of two following~     treatment sequences: Kemstro/conventional baclofen or conventional baclofen/Kemstro.~   "
260510|NCT00139776|"~     To determine whether continuous use of celecoxib over a 6-month period is more efficacious~     than usual or intermittent use in preventing spontaneous osteoarthritis flares of the knee~     and hip.~   "
260511|NCT00139763|"~     This is a questionnaire based study (no study drug is involved) that asks if more patients~     with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment~     choice if inhaled insulin were available in addition to all currently available treatments,~     compared with if inhaled insulin was not available as part of currently available treatments.~      This study will also ask if patients with uncontrolled type 2 diabetes currently managed on~     diabetes pills + once daily insulin will choose as the next treatment choice to take insulin~     multiple times a day if inhaled insulin were available in addition to all currently available~     treatments, compared with if inhaled insulin was not available as part of currently available~     treatments.~   "
260512|NCT00139750|"~     The purpose of the study is to examine the safety and efficacy and dose-response relationship~     of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation;~     including post-treatment follow-up of smoking status to one year from randomization. A small~     satellite protocol (A3051048) investigated safety of a second course of therapy in subjects~     who did not quit.~   "
260513|NCT00139737|"~     To provide treatment to eligible subjects who have successfully completed one of the~     following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or~     A1281088 (NCT00143351).~   "
260514|NCT00139724|"~     To evaluate efficacy of tolterodine extended release formulation compared with immediate~     release formulation in subjects with symptoms of overactive bladder~   "
260515|NCT00139711|"~     A multicenter randomized phase II study evaluating the activity and tolerability of three~     different combinations of docetaxel (taxotere) and irinotecan (campto) as second line therapy~     for recurrent or metastatic non small cell lung cancer (NSCLC)~   "
260516|NCT00139698|"~     Efficacy, tolerability and safety of olmesartan alone or in combination with~     hydrochlorothiazide in the treatment of mild to moderate essential hypertension~   "
260517|NCT00139685|"~     To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive~     Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and~     following discontinuation of DMPA. Another group electing non-hormonal contraception or~     abstinence will be recruited as a reference population, across all study sites. The primary~     variable is BMD, measured by Dual Energy X-ray Absorptiometry (DXA). Secondary variables are:~     Total Body Composition& Total Body Calcium (TBC), measured by Dual Energy X-ray~     Absorptiometry (DXA), and surrogate biologic BMD markers. Safety will be evaluated by adverse~     event reporting, laboratory evaluations, pregnancies, weight and vital signs.~   "
260520|NCT00139646|"~     This is a phase III, multicenter, randomized, single blind study designed to evaluate the~     efficacy and tolerability of a single dose of parecoxib compared with diclofenac in the~     treatment of acute pain due to renal colic.~   "
260521|NCT00139633|"~     This prospective study was designed to assess the outcomes (survival and failure patterns) of~     therapy for localized esophageal cancer with conventional dose radiation (RT; 50.4 Gy) with~     concurrent continuous infusion 5-fluorouracil (5-FU) and weekly carboplatin/paclitaxel.~     Patients with less than complete response (CR) or partial response (PR) received dose~     escalation of radiation to 59.4 Gy with the same chemotherapy.~   "
260522|NCT00139620|"~     This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer~     patients with adequate hepatic function versus cancer patients with moderate hepatic~     impairment. All patients will receive a single 150 mg dose of erlotinib on Day 1 followed by~     96 hours of plasma sampling for PK and protein binding studies. Patients may then enter the~     maintenance phase of the study and continue to receive erlotinib until disease progression or~     unacceptable toxicity.~   "
260523|NCT00139607|"~     This is a phase III, multicenter, open label, pilot to evaluate the analgesic efficacy and~     safety of parecoxib 40 mg IV in the treatment of the pain following hemicolectomy in an~     optimal management of the surgical patient~   "
260524|NCT00139594|"~     This extension study is designed to assess the long-tem tolerability and safety of~     licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.~   "
260525|NCT00139581|"~     This study is not being conducted in the United States.~      To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.)~     versus once daily (o.d.) in preventing the progression to disease relapse.~   "
260526|NCT00139568|"~     Tegaserod is an aminoguanidine indole compound and a member of a new class of~     5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of~     neurotransmitters from the enteric nerves which in turn stimulate contractility and~     peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic~     constipation in a Chinese population of adult men and women~   "
260527|NCT00139555|"~     Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and~     mortality in patients with high blood pressure, compared to those without LVH. Reduction of~     left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical~     outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in~     patients with high risk hypertension.~   "
260528|NCT00139542|"~     The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between~     the time devoted to administer a defibrillation shock, and the time devoted to chest~     compressions.~      The researchers propose to decrease the periods of interruption of cardiopulmonary~     resuscitation (CPR), while keeping the principle of early defibrillation.~   "
260529|NCT00139529|"~     The purpose of this study is to develop and field test a maintenance of smoking abstinence~     program designed for a predominately low-income, high-risk population of women from a wide~     variety of ethnic and racial backgrounds who have quit smoking because of (or during) their~     pregnancy.~   "
260530|NCT00139516|"~     The study has two objectives/aims:~      Aim 1: To test the efficacy of the intervention among adult smokers with cardiovascular~     disease, pulmonary disease and diabetes mellitus related illnesses (later modified to Chinese~     adults with and without diseases); and~      Aim 2: To examine a set of measures (background, general health, psychosocial, and smoking~     process) that are associated with smoking cessation at 6 and 12 months~   "
260531|NCT00139490|"~     The purpose of this study is to examine the effectiveness and cost effectiveness of two~     organizational interventions aimed at improving blood pressure (BP) control among a~     high-risk, African American home care population.~   "
260532|NCT00139477|"~     In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an~     abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal~     to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in~     Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise)~     or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will~     cross over the treatment arms, i.e., those that were doing diet/exercise intervention only~     will add metformin, those that were doing the diet/exercise plus metformin will discontinue~     the metformin and continue with diet/exercise changes only. Intrahepatic fat contents will be~     measured as well.~      The investigators hypothesize that obese children in these age groups will have increased~     cardiovascular risk related to their obese state before reaching the currently defined~     criteria of metabolic syndrome.~      The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle~     and drug interventions.~   "
260533|NCT00139451|"~     The purpose of the study is to find out if patients with constitutional delay of growth have~     a mismatch between energy intake and utilization (as measured by doubly labeled water) and to~     compare the improvement in growth and energy balance between a group of boys treated with~     growth hormone (GH) alone versus those given GH plus added nutritional supplements for one~     year.~   "
260534|NCT00139438|"~     The purpose of this study is to assess the impact of disease management interventions on~     percent receiving a bone densitometry test and percent appropriately prescribed a medication~     for osteoporosis.~   "
260535|NCT00139425|"~     The purpose of this study is to assess the impact of disease management interventions on bone~     mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years~     or older.~   "
260536|NCT00139399|"~     The purpose of this study is to determine whether the radial artery (artery in the arm) or~     saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass~     surgery, have a greater patency rate (degree of opening)at 5 years after surgery.~   "
260537|NCT00139386|"~     Candesartan is effective in preventing cardiovascular events in patients without restenosis~     after coronary angioplasty. Therefore, the investigators hypothesized that candesartan after~     drug-eluting stent (DES) implantation was also effective in preventing cardiovascular events.~      The purpose of this study is to investigate whether an angiotensin II receptor blocker,~     candesartan, is effective in reducing the incidence of cardiovascular events after~     drug-eluting stent implantation.~   "
263899|NCT00094237|"~     To examine the association of subclinical hypothyroidism and risk of myocardial infarction~     and stroke in a large prospective cohort of post-menopausal women.~   "
260538|NCT00139373|"~     The syndrome of distractibility is a behavioral disorder induced by a lesion or a dysfunction~     of the frontal lobe. This sign is frequent in patients with progressive supranuclear palsy~     (PSP), a neurodegenerative disorder with severe neuronal loss in the prefrontal cortex and~     cholinergic systems, in particular in the Meynert basalis nucleus. This could participate in~     the occurrence of the distractibility in these patients. The aim of this study is to evaluate~     the effect of the donepezil, an anticholinesterase, on the distractibility in PSP patients,~     by using oculomotor and neuropsychological assessments.~   "
260539|NCT00139360|"~     To determine the efficacy as measured by objective tumor response of first-line treatment of~     metastatic melanoma with bevacizumab monotherapy~   "
260540|NCT00139347|"~     The main objectives of this study is to determine vaccine efficacy against severe rotavirus~     (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year~     of age.~   "
260541|NCT00139334|"~     The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV~     vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days~     after the OPV dose).~   "
260542|NCT00139321|"~     Gait disorders and falls are frequent in patients with parkinsonian syndromes. In patients~     with Parkinson's disease (PD), these signs occurred later during the course of the disease in~     comparison to patients with other degenerative parkinsonian disorders. The pathophysiology of~     these symptoms are still not fully understood. Gait initiation challenges the balance control~     system as the body moves from an upright stable static posture to a continuously unstable~     gait. The aim of this study is to analyse the gait initiation process in patients with~     parkinsonian disorders.~   "
260543|NCT00139308|"~     Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial~     consequences in some patients. The pathophysiology is still unknown. Some data suggest an~     dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the~     effect of high frequency stimulation of the internal part of the globus pallidus and/or~     parafascicular-median centre of the thalamus, two structures implicated in the limbic~     circuit, in patients with severe Tourette's syndrome.~   "
260544|NCT00139295|"~     This is a clinical study to investigate the safety and efficacy of hylastan in treating~     patients with symptomatic osteoarthritis (OA) of the knee.~   "
260545|NCT00139282|"~     Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that~     causes a progressive loss of central vision. AMD is the leading cause of blindness among~     adults age 50 or older in the Western world. AMD presents in two different types: dry and~     the more severe wet form. Wet AMD is caused by the growth of abnormal blood vessels in the~     macula. Squalamine lactate is an investigational drug that may prevent the growth of these~     abnormal blood vessels. This study will evaluate the safety and efficacy of Squalamine~     lactate in the treatment of AMD in patients, the exact number of which will be determined~     based on data from the sponsor's ongoing Phase 2 trials.~      The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate~     for Injection administered as intravenous infusions weekly for 4 weeks followed by~     maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the~     control group.~   "
260546|NCT00139269|"~     The purpose of this study is to determine the appropriate dose, that dose which is found to~     give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and~     5-fluorouracil and then to further define the safety and effectiveness of this combination of~     medications.~   "
260547|NCT00139256|"~     This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone~     versus a placebo given prior to the mothers at term and near term gestation (>34 and <40~     weeks of gestation) who are scheduled to undergo a planned Cesarean section. The study design~     is to determine the efficacy and safety of betamethasone in the prevention of breathing~     problems commonly seen in this population.~      In infants born by elective Cesarean section, it is hypothesized that antenatal betamethasone~     treatment will reduce the risk of neonatal intensive care unit (NICU) admission from 11% to~     8% and/or oxygen therapy +/- positive pressure ventilation (PPV) for >30 minutes from 4.5% to~     2.5%.~   "
260548|NCT00139243|"~     The purpose of this study is to determine the safety and maximum tolerated dose of the~     combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily~     assess whether the combination is effective in treating squamous cell carcinoma of the head~     and neck.~   "
260549|NCT00139230|"~     The purpose of this study is to further test a combination chemotherapy regimen for the~     treatment of squamous cell carcinoma of the head and neck and to see if the addition of~     supportive medicine can help reduce the side effects of these drugs.~   "
260550|NCT00139217|"~     The primary objective of the trial is to determine the feasibility and clinical safety and~     efficacy of non-invasive inhaled nitric oxide in infants with PPHN without significant~     pulmonary +-parenchymal disease who would normally receive inhaled nitric oxide only after~     placement of a tracheal tube and the institution of mechanical ventilation.~   "
260551|NCT00139204|"~     The purpose of this study is to better understand a new type of radiology test called~     positron emission tomography (PET) with carbon 11 methionine to determine which patients have~     a beneficial effect from anti-cancer therapy with the drug docetaxel.~   "
260552|NCT00139191|"~     The purpose of this study is to understand if a new type of radiology test called positron~     emission tomography (PET) with carbon 11 acetate will help us to understand which cancers~     produce more of a protein called fatty acid synthase (FAS).~   "
260553|NCT00139178|"~     Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV~     infected individuals. However an increasing number of HIV-patients have developed metabolic~     and morphological alterations including peripheral lipoatrophy.~      The main hypothesis of the study is that switching from thymidine-analogue based HAART will~     reverse lipoatrophy.~      We plan to perform an observational study recruiting up to 100 HIV-infected patients~     receiving Trizivir (zidovudine/lamivudine/abacavir).~      The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can~     choose to continue with Trizivir.~      The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.~   "
260584|NCT00138775|"~     The goal of the present study is to evaluate the effect of D-serine, added to antipsychotic~     treatment, on negative and cognitive symptoms in schizophrenia.~      The investigators are hypothesizing that D-serine will improve cognitive functioning and~     negative symptoms.~   "
260554|NCT00139165|"~     The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis.~     All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks~     treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms~     (number of daily stools)~   "
260555|NCT00139152|"~     The purpose of this study is to study the effects of Xolair using non-invasive techniques~     from the expired gas of patients with moderate to severe allergic asthma.~   "
260556|NCT00139139|"~     Immune globulin is effective about 85% of the time in preventing hepatitis A in people who~     have been exposed, if it is given within 14 days of exposure. Several lines of evidence~     suggest that hepatitis A vaccine might also be effective in this setting, and vaccine has the~     advantage of providing long term protection. In this study, we compare how well immune~     globulin and hepatitis A vaccine work in preventing clinical hepatitis A in household~     contacts of persons with the disease. The study's hypothesis is that the the proportion of~     exposed household contacts who receive hepatitis A vaccine within 14 days of exposure and~     develop hepatitis A disease will be similar to the proportion of exposure household contacts~     who receive immune globulin within 14 days of exposure and develop hepatitis A disease.~   "
260557|NCT00139126|"~     The purpose of this study to evaluate whether (1) targeted smoke alarm education, (2) general~     fire safety education with a smoke alarm component, (3) basic fire safety education, or (4)~     an unrelated intervention is most effective way to improve smoke alarm maintenance and~     function.~   "
260558|NCT00139113|"~     Infants born to immune mothers and therefore having passively-transferred maternal antibody~     (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We~     compared the immunogenicity of hepatitis A vaccine among infants with and without PMA,~     vaccinated on different schedules. We found that when vaccination is begun at or after 12~     months of age, there was no difference in the immune response to the vaccine between infants~     born to immune vs. susceptible mothers.~   "
260559|NCT00139100|"~     Introduction. Lymphatic filariasis is a devastating mosquito-transmitted parasitic disease~     that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of~     whom are women. In these persons, frequent bacterial infections (acute attacks) of the legs~     adversely affect physical health, economic well-being, and quality of life. Prevention of~     bacterial infections through hygiene and skin care can result in significant improvements in~     lymphedema and patient well-being.~      Methods. To determine the extent to which antibacterial soap can help reduce the incidence of~     acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200~     patients of the Ste. Croix Hospital lymphedema treatment clinic in Leogane, Haiti randomly~     assigned to receive either antibacterial (Safeguard) or placebo (Camay) soap and acute~     attacks monitored monthly for 12 months. Both groups received specific instructions on~     washing and skin care.~   "
260560|NCT00139087|"~     The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new~     mothers or caregivers of HIV-exposed children with administering medication for the first 6~     weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible,~     mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at~     Delivery Study. Mothers or caregivers of infants were randomized into two groups: the~     intervention group received a cellular phone and scheduled twice daily calls to assure infant~     medications were given, and the other group received the current standard of care. Enrollment~     into the study was completed and analysis of the study data is underway.~   "
260561|NCT00139074|"~     The primary purpose is to investigate whether the addition of sodium valproate will be~     superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14~     days in non-responding patients after a 14 day initial treatment period with quetiapine.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
260562|NCT00139061|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To assess the HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs.~     fenofibrate.~   "
260563|NCT00139048|"~     Women who access the website, are aged between 38-45 years and are considering screening~     mammograms will be randomized to either the Decision Aid (a booklet providing information and~     exercises to help them to make a decision about whether to having screening mammograms) group~     or the Control Group. The Decision Aid group will first read the decision aid, and then will~     be asked some demographic and knowledge questions. The control group will be asked the~     demographic and knowledge questions only. The control group will have access to the Decision~     Aid after they have completed the questions~   "
260564|NCT00139035|"~     Our primary aim is to investigate if cyclosporine A reduces insulin secretion.~   "
260565|NCT00139022|"~     Obstructive Sleep Apnea (OSA) is a common and underrecognised condition. The diagnosis of OSA~     is typically made after an in-lab polysomnography (PSG) which requires an overnight stay in a~     sleep laboratory. Many sleep laboratories have long waiting lists for PSG. There are a number~     of portable devices which may be useful in home diagnosis of OSA, however there is limited~     data on outcomes of OSA diagnosed and treated at home. In this study we propose to compare~     diagnostic accuracy of a home monitoring device with a PSG and outcomes of OSA therapy when~     implemented at home vs in the sleep laboratory.~   "
260566|NCT00139009|"~     The primary objective is to investigate intralymphocyte concentrations of CsA in renal and~     heart transplant recipients to elucidate the association between the intracellular~     concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA~     based immunosuppressive therapy.~   "
260567|NCT00138996|"~     Quality of bystander cardiopulmonary resuscitation (CPR) affect patient survival. Quality of~     professional CPR on patients has not been studied in detail, but it is regularly reported~     that the quality when tested on manikins deteriorates dramatically within months after~     training. Automated direct feedback on CPR quality from manikins brings quality back within a~     couple of minutes. Similar feedback has been incorporated into a defibrillator which also~     monitors quality of CPR. We hypothesise that quality of professional clinical CPR improves~     with such feedback~   "
260568|NCT00138983|"~     The purpose of this study is to determine wich treatment is the most effective in prevention~     of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a~     randomized placebo controlled trial with alendronate versus alfacalcidol.~   "
260569|NCT00138970|"~     To compare renal function (51Cr-EDTA clearance) 12 months posttransplant, in primary renal~     allograft recipients (from cadaveric donor) at low immunogenic risk, 0 DR mis-match,~     receiving immunosuppressive therapy with A) Zenapax® (5 doses), CellCept® (1.5 g bid., aiming~     for TDM for total trough concentrations of 2-6 mg/L) and prednisolone or B) Sandimmun Neoral®~     (full dose), CellCept® (1.0 g bid.) and prednisolone.~   "
260570|NCT00138957|"~     The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia~     repair using an intraperitoneally placed Proceed mesh, looking at postoperative~     complications, recurrence rate and postoperative pain and quality of life.~   "
260571|NCT00138944|"~     Resistant hypertension is defined as hypertension not controlled (i.e. blood pressure not~     below 140/90 mmHg) with the use of adequate doses of at least three different~     anti-hypertensives including a diuretic. Resistant hypertension is abundant. In the ALLHAT~     trial 34% of patients did not reach the blood pressure goal of 140/90 mmHg. One possible~     mechanism of resistance is the aldosterone-escape phenomenon.~      During aldosterone escape, aldosterone plasma levels are normal or even elevated despite~     therapy with ACEIs or ARBs. The prevalence is about 30-50%. Possible reasons for aldosterone~     escape are alternative ways of aldosterone stimulation (hyperkalemia, adrenomedullin, ACTH),~     local aldosterone production or primary aldosteronism. Aldosterone has deleterious blood~     pressure independent effects on cardiac, vascular and renal damage.~      Hypothesis: Eplerenone is effective to improve hypertensive target organ damage in patients~     with resistant hypertension.~   "
260572|NCT00138931|"~     We are studying the genetics of human cardiovascular and neuromuscular disease. There are~     many different genetic regions that have been associated with the development of~     cardiomyopathy. An equal number of genetic regions have been associated with muscular~     dystrophy and there is overlap because some of the identical genes, when mutated, produce~     both cardiomyopathy and muscular dystrophy. We are working to identify genes and gene~     mutations associated with cardiomyopathy, arrhythmias and muscular dystrophy. We propose to~     screen these samples for mutations in genes known to be involved in these disorders.~   "
260573|NCT00138918|"~     The purpose of this trial is to assess the effects of combined therapy with androgen ablation~     and OGX-011 (an antisense to clusterin) given prior to radical prostatectomy on pathologic~     complete response rates in men with localized prostate cancer and high risk features.~   "
260574|NCT00138905|"~     The purpose of this study, is to investigate if low intensity electromagnetic radiation, can~     influence the cognitive performances and well being of healthy adolescents and adults.~     Furthermore, the purpose is to provide any special information about the subjects which can~     cause the possible reactions. Finally, the investigation will try to clarify if there is~     anything specific in the radiation signal that causes the effect~   "
260575|NCT00138892|"~     The primary research question is: Does expedited hip and knee replacement result in improved~     lower-extremity function at 36 months post randomization as measured by the Western Ontario~     McMaster Universities Osteoarthritis Index (WOMAC)? A secondary component to this question is~     whether expedited surgery improves pain and stiffness scores as measured by the WOMAC and~     generic QOL as measured by the Medical Outcomes Study Short-Form 36 (SF-36) and Health~     Utilities Index Mark 3 (HUI3)? Secondary questions are: Does joint-specific and generic QOL~     deteriorate significantly during waiting? Does prolonged waiting increase the economic cost~     associated with hip and knee arthroplasty? And does expedited surgery have an effect on~     patient satisfaction with major joint replacement?~   "
260576|NCT00138879|"~     Citrulline is an amino acid produced in the intestine and in the liver, but the liver does~     not contribute significantly to circulating citrulline concentrations. The intestine is thus~     the only organ that normally releases significant amounts of citrulline into the blood. The~     investigators have designed a study looking at the value of measuring plasma citrulline~     concentration in patients with Crohn’s disease and short bowel or normal intestinal length.~     Measuring the plasma citrulline concentration in short bowel patients may help to distinguish~     between patients who need permanent parenteral feeding from patients with just transient~     intestinal dysfunction. It may also help the investigators in understanding the small bowel~     intestinal length remaining and the absorptive integrity. In patients with normal intestinal~     length and Crohn’s disease, it may be a reliable marker of small bowel damage and could be~     applied to establish therapeutic improvements. It has been demonstrated to strongly correlate~     (inversely) with severity on intestinal biopsies.~      The investigators hypothesise that the plasma citrulline concentration is a marker for small~     bowel absorptive integrity and an appropriate surrogate for functional length of the small~     intestine.~      Controlled data do not yet exist to establish the place of plasma citrulline in the~     assessment of small bowel function in man.~   "
260577|NCT00138866|"~     The purpose of this study is to find out if risedronate works for the treatment of~     osteoporosis for people with spinal cord injury.~   "
260578|NCT00138853|"~     The purpose of this study is to compare the early migration of two uncemented total knee~     arthroplasties with different metal coating. Only the tibial prosthesis plateau varies. One~     is made out of tantalum and has two short pegs for fixation into the tibia while the other is~     covered by titanium fiber-mesh on the bone-near site and has 4 short pegs for screw fixation~     into the tibia.~   "
260579|NCT00138840|"~     STA-5326 is an experimental drug that has been shown to block the release of interleukin-12~     from peripheral blood mononuclear cells. Given this activity on the immune system, STA-5326~     mesylate is a potential treatment for various autoimmune diseases, such as Crohn's disease,~     that are mediated by the inappropriate expression of Th1 cytokines.~      This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe,~     active Crohn's disease. Study visits include a screening visit, 9 treatment period visits~     over 6 months and a follow-up visit that will occur 30 days following the end of treatment.~     Study drug treatment will continue for up to 6 months.~   "
260580|NCT00138827|"~     The purpose of this study is to assess whether Biotene oral care products have a benefit in~     the treatment of xerostomia and mucositis when compared with conventional bicarbonate mouth~     care regimes.~   "
260581|NCT00138814|"~     This is a two arm randomized study for patients who are undergoing radiotherapy following~     breast conservation surgery for breast cancer. Local recurrence of breast cancer will be~     compared for patients receiving boost or no boost radiotherapy.~   "
260585|NCT00138762|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or~     placebo.~   "
260586|NCT00138749|"~     A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of~     stress urinary incontinence.~   "
260587|NCT00138736|"~     The pharmacokinetics, and clinical and biological effects of MBL replacement therapy in~     MBL-deficient children during chemotherapy-induced neutropenia were studied.~   "
260588|NCT00138723|"~     This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine~     fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive~     bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter~     trial.~      The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2~     week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving~     either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the~     double-blind Treatment period.~      Two primary efficacy variables will be assessed for submission in the United States: change~     in the average number of micturitions (frequency) per 24 hours and the change in the average~     number of urge incontinence episodes per 24 hours. For the submissions in the European Union,~     the first primary variable will be the change in the average number of micturitions~     (frequency) per 24 hours and the co-primary variable is the treatment response, based on a~     treatment benefit scale. All continuous variables will be measured as changes from baseline~     to value after 12 weeks of treatment. The following safety variables were observed and~     assessed: adverse events, change in residual urinary volume (mL), change in laboratory~     parameters, change in vital signs, change in electrocardiogram (ECG), change in physical~     examination and change in urological/urogynecological examination.~   "
260589|NCT00138710|"~     In this study, 50 obese men with a hormonal imbalance will be treated with letrozole or~     placebo for six months in order to examine the effects on the hormonal balance, and on weight~     loss. The study will also address the side effects and psychological effects of letrozole as~     compared to placebo.~   "
260590|NCT00138697|"~     The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L,~     were studied in patients with hypogammaglobulinemia, who are regularly treated with~     intravenous immunoglobulin substitution therapy.~   "
260591|NCT00138684|"~     The aim of the study is to determine, in patients presenting hepatic iron overload (genetic~     haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy~     on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone~     before and after venesection.~   "
260592|NCT00138671|"~     A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics~     with Chronic Obstructive Pulmonary Disease.~   "
260593|NCT00138658|"~     This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination~     with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective~     treatment for patients with lung cancer. This study will help to assess the safety and~     anti-tumor effect of OGX-011 when given to patients in combination with GEM and CIS/CARB.~   "
260594|NCT00138645|"~     It is hypothesized that the use of a partial supplement diet, which includes the use of meal~     replacements, will result in significantly greater weight loss after three and six months~     compared to an isocaloric diet that does not include supplements. It is also hypothesized~     that the partial supplement diet will result in larger improvements in body composition,~     disease biomarkers, and health parameters (blood pressure, lipids) compared to the~     non-supplement diet. Finally, it is hypothesized that subjective ratings of satiety will be~     significantly higher, and ratings of hunger lower, in the group consuming a partial~     supplement diet.~   "
260595|NCT00138632|"~     This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets~     given daily. It also explores the efficacy of the compound in patients with wet age-related~     macular edema.~      In Cohort 1 verteporfin/PDT is the active control. The protocol was amended to reflect the~     current standard of care for AMD. As a result, ranibizumab is the active control for Cohort~     2.~   "
260596|NCT00138619|"~     This is an 80-week extension to a study to assess the safety and effectiveness of~     vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose~     levels in people with type 2 diabetes who have not previously been treated with drug therapy~     to lower their blood sugar. The purpose of the extension study is to gather data on the~     long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.~   "
260597|NCT00138606|"~     Many people with type 2 diabetes cannot maintain their target blood glucose levels on a~     single therapy. This is a 28-week extension to a study to assess the safety and effectiveness~     of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to~     insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin~     alone. The purpose of the extension study is to gather data on the long-term safety and~     effectiveness of vildagliptin in people with type 2 diabetes.~   "
260598|NCT00138593|"~     This study is not being conducted in the United States. This is a 52-week extension to a~     study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved~     drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not~     previously been treated with drug therapy to lower their blood sugar and whose blood sugar~     levels were in a specified range. The purpose of the extension study is to gather data on the~     long term safety and effectiveness of vildagliptin in people with type 2 diabetes.~   "
260599|NCT00138580|"~     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a~     single oral drug. This is a 28-week extension to a study to assess the safety and~     effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels~     when added to glimepiride in people with type 2 diabetes not at target blood glucose levels~     on a sulfonylurea alone. The purpose of the extension study is to gather data on the~     long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.~   "
260600|NCT00138567|"~     This is a 52-week extension to a study to assess the safety and effectiveness of~     vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose~     levels in people with type 2 diabetes who have not been previously treated with drug therapy~     to lower their blood sugar. The purpose of the extension study is to gather data on the~     long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.~   "
260601|NCT00138554|"~     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a~     single oral drug. This is a 28-week extension to a study to assess the safety and~     effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels~     when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels~     on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data~     on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.~   "
260602|NCT00138541|"~     This is a 28-week extension to a study of the safety and effectiveness of three doses of~     vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose~     levels in people with type 2 diabetes who have not been previously treated with drug therapy~     to lower their blood sugar. The purpose of the extension study is to gather long-term safety~     and efficacy data for vildagliptin in people with type 2 diabetes.~   "
260603|NCT00138528|"~     Other effects of fluvastatin are investigated in German patients with metabolic syndrome.~   "
260604|NCT00138515|"~     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a~     single oral drug. This is a 28-week extension to a study to assess the safety and~     effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels~     when added to metformin in people with type 2 diabetes who are not at target blood glucose~     levels on metformin alone. The purpose of the extension study is to gather data on the~     long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.~   "
260605|NCT00138502|"~     The purpose of the study is to test the hypothesis that a subpopulation of patients with~     candiduria are at significant risk for disseminated disease and would benefit from treatment,~     while others are at low risk from complications and therefore require no antifungal therapy.~   "
260606|NCT00138489|"~     The purpose of this study is to learn more about vivax malaria in very young children, how~     the growth of children is affected by malaria infections, and how inherited traits protect~     children from getting malaria. Participants will be 266 children 24 months of age or younger~     who live in certain villages in East Sepik Province, Papua New Guinea, where malaria is very~     common. The study also will find out how malaria spreads in the area. By learning how and~     when a child develops resistance to vivax malaria, researchers can try to find ways to help~     people from getting it. And, they can get a better understanding of how inherited traits~     influence all types of malaria infections. In this study, the parent and child will be~     visited by the study team or health workers every week to check health and bednet use. Every~     2 weeks, the study team will take a small blood sample to check for malaria and take~     measurements to study the child's growth. Participants will be followed for up to 2 years.~   "
260607|NCT00138476|"~     The main objective of this study is to see the number of volunteers that get sick from a~     Norwalk virus (NV) inoculation with typical symptoms of nausea, vomiting, and diarrhea. If~     this NV preparation is shown to cause Norwalk illness, then it can be used to test new~     vaccines in the future. Additionally, researchers hope to determine the lowest dose of NV~     inoculum that can be given to volunteers and cause illness. Study participants will include~     57 healthy adults, ages 18-50. Participants will either be given the NV inoculum or placebo~     (water without virus). Participants will be hospitalized for a maximum of 7 days and a~     minimum of 4 days following the NV challenge. Study procedures include physical exam, blood~     testing, and collection of saliva, urine, and stool samples. Participants will be involved in~     study related procedures for up to 180 days.~   "
260608|NCT00138463|"~     West Nile Virus causes an infection that is spread to humans when bitten by certain types of~     mosquitoes. Mosquitoes become infected by biting infected birds. The purpose of this study is~     to find out more about West Nile Virus, which may assist in the design of better treatments.~     The study will be looking at the effects of the disease on individuals, specifically their~     nervous systems, and the outcomes of the disease. Study participants will include 120 adults~     ages 18 and older, who have either a fever and/or changes in their neurological (involving~     the brain and nervous system) status due to documented West Nile Virus infection. Study~     procedures will include physical examinations, blood tests, urine tests, cerebral spinal~     fluid (fluid in and around the brain and spinal cord) tests, and neurological (nervous~     system) testing. Study participants will be followed for 12 months.~   "
260609|NCT00138450|"~     The purpose of this study is to determine what causes some people to become sick, and others~     not, when they are infected with the parasite Schistosoma haematobium, also known as~     Bilharzia. This is an infection of the urinary tract blood vessels and can cause serious~     disease. Approximately 4400 adults and children of any age will participate in this study.~     They must be residents of the Msambweni Area, Kwale District, Coast Province, Kenya, where~     infection with S. haematobium parasites are common. To find out if people are infected, they~     will first provide 1 or more urine samples for a microscope examination to detect if the S.~     haematobium parasites are present in the body. Volunteers then will be examined by ultrasound~     to see if they have kidney or bladder disease. (Ultrasound examination is the use of a~     non-painful machine that uses sound waves to examine the condition of the internal organs.)~     Treatment with the drug praziquantel will be offered if S. haematobium infection is found.~   "
260610|NCT00138437|"~     The purpose of this study is to determine what factors contribute to the continued incidence~     of leprosy in Colombia. Study participants will include volunteering and consenting~     individuals, older than 4 years of age, representing three study groups:~        1. healthy persons with no known contact with leprosy patients~        2. patients reporting at Instituto Colombiano de Medicina Tropical-CES and Impresa Social~          del Estado Sanatorio Agua de Dios with a new diagnosis of leprosy or relapse of leprosy~        3. household contacts of leprosy patients described in group 2. Blood, nasal swabs, slit~          skin smears, and biopsies will be taken from the volunteers to learn the strains of~          leprosy-causing bacteria in the area, the immune responses (body's response to disease)~          in local residents against the bacteria, and the pattern of leprosy transmission.~          Individuals will participate in this study for 1-10 days, and the study will last for 3~          years.~   "
260656|NCT00137826|"~     The purpose of this study is to determine whether the combination of the investigational~     drugs Avastin and Tarceva are effective in patients with mesothelioma who have previously~     been treated with chemotherapy.~   "
260657|NCT00137813|"~     The purpose of this study is to determine what effects (good and bad) bevacizumab (Avastin)~     and docetaxel (Taxotere), used in combination, have on metastatic gastric and esophageal~     cancer.~   "
260611|NCT00138424|"~     This study will look at the safety, tolerability and effectiveness of cidofovir in kidney~     transplant patients who have been diagnosed with BK virus nephropathy (BKVN), a viral~     condition that can cause patients to reject transplanted kidneys. Up to 48 adult (age 18~     years and older) kidney or pancreas transplant recipients with newly diagnosed BKVN will~     receive 1 of 3 cidofovir dose levels or placebo (non medicated substance) to identify the~     maximum tolerated dose. Dosing will be administered intravenously (by a tube running into a~     blood vessel). In addition to the screening visit, volunteers will actively participate for~     approximately 8-10 weeks with a single follow up phone call at 4 months. Blood samples, urine~     samples, eye exams and physical exams are included in study procedures.~   "
260612|NCT00138411|"~     The purpose of this study is to evaluate the safety and pharmacokinetics (how long a drug~     stays in the bloodstream and how high the levels of the drug are at different times) of~     ETI-204 following intravenous (IV-into a vein) injections, and to evaluate the effects that~     ETI-204 may have on the pharmacokinetics of oral (by mouth) ciprofloxacin, an antibiotic~     approved by the U.S. Food and Drug Administration (FDA). ETI-204 is an experimental drug (not~     approved by the FDA) intended to protect against anthrax (a bacterial infection).~     Approximately 36 male and female healthy volunteers ages 18 to 50 will be in this study.~     Participation in this study may last up to eight weeks. Volunteers will have a single IV dose~     of the ETI-204 study drug or placebo (inactive substance, and some participants will also~     receive ciprofloxacin. They will stay in the Clinical Pharmacology Unit at least 36 hours~     after the dose.~   "
260613|NCT00138398|"~     The purpose of this study is to determine how the immune system changes with aging and makes~     influenza a more serious illness in older people. Influenza vaccination not only can protect~     people from getting the flu but also can lessen the severity of the illness. This is~     particularly true for people with congestive heart failure (CHF). This research may provide~     information that could eventually lead to a new laboratory test that will predict how~     effective vaccination is for preventing influenza illness in older people. Volunteer~     participants in this study will include the following groups: 1) healthy young adults 20 - 40~     years old; 2) older adults, 60 years and older, without a history of CHF; 3) older adults, 60~     years and older, with a history of CHF. All study participants will be vaccinated with the~     current preparation of inactivated influenza vaccine. A small amount of blood will be drawn~     before each vaccine and at 4, 10, and 16-20 weeks afterward.~   "
260614|NCT00138385|"~     The purpose of this study is to evaluate how young children's bodies learn to fight against~     flu infection and to see how vaccines may help to fight against the flu. This is a Phase 4,~     single-center, randomized study of the immune responses of 40 children, ages 5-9, given one~     of two licensed influenza vaccines (either inactivated vaccine given in an arm muscle or~     live, attenuated vaccine inhaled through the nose). Study procedures will include up to 3~     blood samples. Participants will complete a diary to document any side effects experienced~     following the vaccination. Participants will return to the clinic for a visit on Day 7-9 and~     again 4-6 weeks following vaccination. Participants that have not been previously vaccinated~     will receive a 2nd dose of vaccine. A follow up telephone call will occur 8-10 weeks~     following vaccination. Total study participation will be up to 75 days.~   "
260615|NCT00138372|"~     This is a study of 125 healthy male and female Kenyan adults aged 18 years and above, and 300~     healthy male and female Kenyan infants enrolled at 1 month of age and followed to 3 years of~     age. Twenty healthy adults (US residents) who have no self-reported history of Malaria~     exposure, infection or travel to malaria endemic areas of the world will serve as Malaria~     Naive Negative Controls. The proposed study represents a continuation of molecular and~     immunologic studies done in human populations describing mechanisms of protection against~     malaria infection and disease. Human investigation of those experiencing natural exposure to~     malaria infections are justified since they will eventually be the target population for~     testing malaria vaccine safety and efficacy.~   "
260616|NCT00138359|"~     Investigators from Cayetano Heredia University and Johns Hopkins University are doing this~     study. They want to see how people and pigs get infected with a parasite, called cysticercus~     (known as pig triquina). Cysticercus attacks the meat of pigs and the brains of people. In~     the intestine, the parasite is known as solitaria. This study is to see how treatment in~     both people and pigs works to control the disease.~   "
260617|NCT00138346|"~     This is a study developed by researchers from the Universidad Peruana Cayetano Heredia, the~     Universidad Mayor de San Marcos and other local and foreign institutions. Researchers are~     performing this research in human beings and animals, in order to determine the best way to~     understand and eliminate a parasite called Echinococcus granulosus (tapeworm). The parasite~     grows and develops in the dogs´ bowel. The tapeworm produces eggs which are eliminated among~     the feces and remain in the environment. Individuals may accidentally ingest the eggs through~     contaminated food or drinks and develop a disease called cystic hydatid disease. This disease~     mainly affects the human lungs and liver. The parasite grows in the shape of a water bag and~     it can jeopardize human life. It also affects sheep, goats, llamas and alpacas. The study~     will enroll almost 840 volunteers who are older than 5 years of age. It will last about 3~     years.~   "
260618|NCT00138333|"~     The goal of the study is to find out how much mercury is in the blood, urine, and stools of~     premature and low birth weight infants who have received standard childhood vaccines that are~     given to all infants in Argentina. Seventy-two newborn premature and low birth weight infants~     from Durand Acute General hospital will participate in this study. Each infant in the study~     will need to make two visits, one at the time of vaccination and another 12 hours to 30 days~     later. Urine, stool, and a small sample of blood will be taken at each visit.~   "
260631|NCT00138151|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor~     is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b together~     with paclitaxel may reduce drug resistance and allow the tumor cells to be killed.~      PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alpha-2b~     together with paclitaxel works in treating patients with stage IV, recurrent, or persistent~     cervical cancer.~   "
260694|NCT00137332|"~     The purpose of this study is to learn the effects of a test drug on heart rhythms, which may~     become life-threatening if left untreated, and to provide data to see if the drug is well~     tolerated and safe.~   "
260619|NCT00138320|"~     The purpose of this study to look at the antibodies (proteins from the body's infection~     fighting system) in the blood of babies delivered by women who are participants in the~     Herpevac Trial for Women, and who were vaccinated with either two or three doses of~     (GlaxoSmithKline) GSK candidate vaccine gD2t/alum-MPL or hepatitis A vaccine. The goal of~     this study is to compare the herpes or hepatitis A antibody levels of the newborns to those~     of their mothers, and to see how much of the antibodies are still present in the baby at two~     and six months after birth. Approximately 2 teaspoons (10 ml) of the mother's blood will be~     collected at the time of delivery or within 15 days before or after delivery. Approximately 2~     teaspoons of blood will be collected from the child's umbilical cord at the time of delivery,~     or 1 teaspoon (3-5 ml) of the child's blood will be drawn within 15 days after birth.~     Optional blood draws from babies may occur 2 and 6 months after birth.~   "
260620|NCT00138307|"~     Malaria is a sickness passed from one person to the other by the bite of a mosquito. In areas~     of frequent malaria infection, children may develop natural protection against malaria and~     they are less likely to become sick or die from it as they age. The purpose of this study is~     to investigate the body's natural protection against malaria in children by testing their~     blood. This information may help investigators develop a malaria vaccine. The Navrongo Health~     Research Centre is conducting this study in Ghana. Three hundred healthy children between the~     ages of 1 and 5 years will participate in the study for 12 months. Study procedures will~     include 7 field worker visits to check on the child's health and obtain a blood sample. Every~     two months, a blood sample will be taken from each child to test it for strength against~     malaria. Whenever a child is sick, the child will be tested for malaria.~   "
260621|NCT00138294|"~     The main purpose of this study is to learn if influenza vaccines (live attenuated and~     inactivated influenza vaccines), when given to school-aged children 4 to 18 years of age, can~     stop or lessen the influenza (flu) outbreak in the community. Another purpose is to show that~     vaccination of these children will significantly reduce breathing problems (in the vaccinated~     children and unvaccinated people they come in contact with in the community) that require a~     visit to the doctor for treatment. Another purpose is to continue to collect safety and flu~     protection information on live attenuated influenza vaccine (LAIV or FluMist) given to~     children. The study investigators believe that vaccination of healthy school-aged children is~     an effective plan for preventing many people in the community from catching the flu. Children~     will take part in the study for 5 to 10 months.~   "
260622|NCT00138281|"~     Sixty adults, ages 18-49, will be randomly assigned to receive either FluMist or Fluzone.~     Some of the subjects will have participated in previous studies for these 2 vaccines. The~     study will last 4 months with subject participation being 28 days. The purpose of this study~     is to measure immune response to the vaccinations.~   "
260623|NCT00138268|"~     To evaluate and standardize umbilical cord specimen collection and laboratory procedures to~     evaluate cellular and serological immune responses in neonates and young infants~   "
260624|NCT00138255|"~     The purpose of this study is to see if the MMR and chickenpox vaccines work as well in~     premature infants as in children that were carried to full term. A group of children who were~     carried full-term will be matched for age, sex, and race and will be used for comparison.~   "
260625|NCT00138242|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin~     works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity~     cancer.~   "
260626|NCT00138229|"~     RATIONALE: An infusion of a patient's lymphocytes that have been treated in the laboratory to~     remove certain immune cells may be an effective treatment for melanoma. Drugs, such as~     cyclophosphamide and fludarabine, may suppress the immune system so that the patient's immune~     cells allow the infused lymphocytes to work. Interleukin-2 may help the lymphocytes kill more~     tumor cells when they are put back in the body. Giving cyclophosphamide and fludarabine~     followed by an autologous lymphocyte infusion and interleukin-2 may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine~     followed by an autologous lymphocyte infusion and interleukin-2 works in treating patients~     with refractory or recurrent melanoma.~   "
260627|NCT00138216|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, vincristine, and irinotecan,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when~     given together with temozolomide and vincristine in treating young patients with refractory~     solid tumors.~   "
260628|NCT00138203|"~     This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating~     patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Drugs used in~     chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
260629|NCT00138177|"~     This phase I trial is studying the side effects and best dose of suberoylanilide hydroxamic~     acid when given together with fluorouracil, leucovorin, and oxaliplatin in treating patients~     with progressive metastatic or unresectable colorectal cancer or solid tumor. Drugs used in~     chemotherapy, such as suberoylanilide hydroxamic acid, fluorouracil, leucovorin, and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more~     than one drug (combination chemotherapy) may kill more tumor cells.~   "
260630|NCT00138164|"~     RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry~     cancer-killing substances directly to non-Hodgkin's lymphoma cells.~      PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating~     patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.~   "
260695|NCT00137319|"~     This study will see if a special piece of equipment can help burn patients who have been in~     bed for a long time to get out of bed without feeling dizzy or faint.~   "
260632|NCT00138138|"~     Fatigue is one of the most common symptoms of prostate cancer. Fatigue is a lack of energy~     that makes it harder to do the things you normally do every day. Some symptoms of fatigue~     are:~        -  feeling tired and/or weak;~        -  having less interest in activities;~        -  having trouble concentrating;~        -  feeling down;~        -  feeling exhausted for no clear reason.~      There are not many drugs that are helpful in treating fatigue. However, one group of~     medications does seem to be useful. In this study, we, the investigators at Memorial~     Sloan-Kettering Cancer Center, will be using a psychostimulant called Ritalin. The aim of~     this study is to see if this drug is helpful in treating fatigue in prostate cancer. We are~     also studying the side effects of this medication.~   "
260633|NCT00138125|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes.~     Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. It is not yet known whether giving~     fulvestrant together with trastuzumab is more effective than giving fulvestrant or~     trastuzumab alone in treating breast cancer.~      PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab~     works as first-line therapy in treating postmenopausal women with stage IV breast cancer.~   "
260634|NCT00138112|"~     This is a randomized 2-arm study to compare two different times of giving the drug~     vancomycin. Half of the patients will begin vancomycin two days before a bone marrow~     transplant. The other half will get it as soon as they have the first fever.~      Streptococci are bacteria that live in one's mouth and gut. These bacteria can escape into~     the blood when the lining of the mouth and gut weakens from cancer therapy. This can make the~     person who is undergoing a bone marrow transplant very sick. All patients who get this~     infection are treated with antibiotics. Vancomycin is one drug that is used to treat this~     bloodstream infection once it is diagnosed. Studies have shown that giving vancomycin before~     a bone marrow transplant seems to prevent this infection. However, giving vancomycin too soon~     may increase the chance that the kidneys will be irritated. It may also increase the chance~     that other bacteria will become resistant to this drug. We, the investigators at Memorial~     Sloan-Kettering Cancer Center, do not know if waiting to start vancomycin until the patient~     has a first fever can also prevent this infection.~   "
260635|NCT00138099|"~     The investigators' primary research objective is:~        -  To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive~          Care Unit (ICU) patients based on:~             -  the proportion of patients with trough anti-Xa > 0.40 IU/mL during dalteparin~               prophylaxis after 3 + 1 days, 10 + 1 days, and 17 + 1 days of dalteparin~               prophylaxis;~             -  the risk of major bleeding during the treatment period.~      The investigators' secondary research objectives are:~        -  To determine the pharmacokinetic properties of dalteparin prophylaxis in ICU patients~          with severe renal insufficiency;~        -  To identify clinical and laboratory factors that predict an excessive anticoagulant~          effect (anti-Xa > 0.10 IU/mL);~        -  To estimate the relationship between trough anti-Xa levels and bleeding.~      The DIRECT Pilot Study:~      Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard~     unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation~     of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address~     potential problems with protocol implementation.~   "
260636|NCT00138086|"~     The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM~     preparative regimen before autologous stem cell transplantation (ASCT) as measured by the~     event free survival (EFS).~      The goal is to obtain a 15% increase of EFS at 2 years.~   "
260637|NCT00138073|"~     Skill with pulmonary artery catheter (PAC) waveform interpretation is inadequate among~     physicians and nurses. We, the investigators at Massachusetts General Hospital, have~     developed a web-based computer program to assist physicians and nurses in PAC waveform~     interpretation. We will study the effectiveness of this program on improving the~     interpretation of waveforms on a computer-based test.~   "
260638|NCT00138060|"~     This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the~     identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1~     (UGT1A1) polymorphisms before the first administration.~      The results of this identification determine the chemotherapy type: high-dose irinotecan or~     not.~   "
260639|NCT00138047|"~     The goal of the study is to rule out a harmful effect of zinc supplementation in~     HIV-1-infected children. The null hypothesis is that zinc supplementation will increase~     plasma HIV RNA levels.~   "
260640|NCT00138034|"~     Reocclusion of the infarct artery is observed in about 30% of patients within three months~     after successful thrombolysis for acute myocardial infarction (MI). Reocclusion is associated~     with an increased risk of death, reinfarction and the need for revascularization. Even in the~     absence of clinical reinfarction, reocclusion results in impaired left ventricular (LV)~     recovery, leaving patients at increased risk of developing heart failure in the long-term.~     Prevention of reocclusion is therefore warranted. In previous trials, severity of the infarct~     related stenosis was the only independent predictor of reocclusion. With a lack of clinical~     predictors of reocclusion, many cardiologists therefore empirically favor routine~     revascularization after successful thrombolysis.~      The APRICOT-3 will be the first randomized trial in the current era of improved angioplasty~     techniques to study the question of whether a routine invasive strategy after successful~     thrombolysis can reduce the incidence of reocclusion and subsequently improve clinical~     outcome and LV-function. After successful thrombolysis, patients will be randomized to either~     a routine invasive strategy or an ischemia-guided strategy. The investigators expect to~     demonstrate a lower reocclusion rate at the 6-month follow-up angiography (primary endpoint)~     and fewer associated events (death, reinfarction, revascularization, admissions for heart~     failure) in the routine invasive arm. In search of non-invasive parameters predictive of~     reocclusion, laboratory analysis of several coagulation and inflammatory markers will be~     performed. Finally, pooled analysis of all 3 APRICOT trials will focus on the identification~     of clinical predictors of reocclusion that can easily be obtained by history and physical~     examination.~   "
260655|NCT00137839|"~     The purpose of this trial is to figure out what effects (good or bad) the investigational~     drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated~     adenocarcinoma.~   "
260641|NCT00138021|"~     This project seeks to evaluate the feasibility and effectiveness of combining cognitive~     remediation and Supported Employment Program (SEP) services to improve work outcomes in~     people with a serious mental illness who have been unable to benefit from vocational services~     (i.e., acquire or maintain a job). Cognitive remediation involves treating and improving~     cognitive impairments, such as memory (e.g., short-term and working memory), attention span,~     or problem solving skills. It is hypothesized that cognitive remediation will significantly~     improve peoples' employment outcomes in a supported employment program.~   "
260642|NCT00138008|"~     The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in~     comparison with endocrine therapy alone for PSA failure after radical prostatectomy.~   "
260643|NCT00137995|"~     The primary objective of this study is to evaluate the efficacy and safety of induction~     therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of~     stem cells in patients with previously treated diffuse large B-cell lymphoma CD20.~      The goal is to detect a difference in mobilization adjusted response rate of 15% between~     R-ICE and R-DHAP.~      The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy~     after transplantation as measured by the event free survival.~      The goal is to obtain a 15% increase of event free survival at 2 years.~   "
260644|NCT00137982|"~     Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate,~     conservative surgery or radical surgery. There are no data about subsequent fertility except~     in a cohort study. The investigators propose to evaluate the true subsequent fertility with a~     follow-up of 2 years, in a randomized controlled trial.~   "
260645|NCT00137969|"~     This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to~     evaluate the efficacy and safety of rituximab compared with placebo when combined with a~     single stable background immunosuppressive medication in subjects with moderate to severe~     systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be~     evaluated at 52 weeks.~   "
260646|NCT00137956|"~     The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and~     quality of life information on patients enrolled in the VENT study in order to analyze the~     relative cost-effectiveness of the endobronchial valve implant procedure.~   "
260647|NCT00137943|"~     Parents Matter is a community-based project whose goal it is to develop and test an~     intervention designed to promote effective parent-child communication about sexuality in~     order to promote sexual health among adolescents.~   "
260648|NCT00137930|"~     Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the~     hospitalization of infants and young children in developed and developing countries and can~     be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000~     annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against~     human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative~     buffer, was developed. This study will be conducted to evaluate the new formulation compared~     to the existing formulation of the HRV vaccine.~   "
260649|NCT00137917|"~     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3~     doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a~     0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2~     doses of Havrix™ (0-6 months) and Meningitec™ (month 1).~   "
260650|NCT00137904|"~     Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The~     pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is~     associated with sleep disorders. The aim of this study is to determine the polysomnographic~     parameters in MS patients with fatigue in comparison to MS patients without fatigue.~   "
260651|NCT00137891|"~     Forty-six (46) eligible, healthy subjects who provide written informed consent will be~     enrolled to participate in a 2 arm parallel group study to assess and compare the~     pharmacokinetics and safety profile of Thyrogen dosed at 0.1 mg versus a modified release~     formulation of recombinant human thyroid stimulating hormone (rhTSH) dosed at 0.1 mg. Ten~     (10) of these subjects will have the thyroid uptake of radioiodine (123I) measured at~     baseline and following their single dose of study medication. All doses will be administered~     via intramuscular (IM) injection.~      Following confirmation of study eligibility, subjects will be randomized in a 1:1 ratio to~     receive either a single administration of 0.1 mg of Thyrogen (THYR) or 0.1 mg of the modified~     release.~      Randomization will be stratified by whether or not patients will have the thyroid uptake of~     radioiodine (123I) measured following their single dose of study medication. Five (5)~     patients in each treatment arm will have uptake measured, while 18 in each arm will not.~      Each subject will have blood samples taken to determine the pharmacokinetics of serum TSH at~     -12 hours and just prior to dosing and at various hours up to 14 days following the~     administration of Thyrogen or the modified release formulation. In addition, for the~     evaluation of pharmacodynamics, each subject will have samples of blood taken to determine~     serum free T4, total T4, free T3, and total T3 at -12 hours and just prior to dosing and at~     various hours up to 14 days following the administration of study treatments.~      All subjects will undergo a 12-lead electrocardiogram (ECG) just prior to dose administration~     and 1, 2, 3, 4, 5, 7, 10 and 14 days following study treatment administration. In addition,~     subjects will undergo 24 hours of Holter monitoring at baseline and four (4) consecutive~     24-hour Holter monitoring sessions post treatment to yield a total of 96 hours of continuous~     monitoring of cardiac function following treatment administration. All subjects will undergo~     ultrasound evaluations to determine thyroid volume at baseline and 48 hours following~     treatment administration.~      Twenty-four hours following the administration of Thyrogen or the modified release~     formulation, a subset of five (5) subjects in each treatment arm will receive a dose of 123I~     prepared to be 400µCi on the day of radioiodine administration based on the utilized nuclear~     pharmacy's calibration schedule. Thyroid gland uptake will be measured via a probe in these~     10 subjects at 6, 24 and 48 hours following radioiodine administration.~      Blood chemistry, complete blood count (CBC), urinalysis and a physical exam will be conducted~     14 days after treatment administration, or at the time of early termination, as a final~     safety assessment.~      Each subject's duration of study participation will be approximately 4 weeks.~   "
260652|NCT00137878|"~     The purpose of this study is to determine if the addition of TNFerade™ to pre-operative~     chemoradiotherapy increases the number of pathologic complete responses when compared to~     pre-operative chemoradiotherapy alone as assessed following complete surgical resection of~     primary rectal cancer.~   "
260653|NCT00137865|"~     Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the~     cells of the body. Because the genes are damaged, the body is unable to produce a group of~     proteins called cytokines which are used by the immune system to fight cancer and some~     infections. The investigational gene transfer agent EGEN-001 (phIL-12-005/PPC) contains the~     human gene for interleukin-12 [IL-12] (a cytokine) in a special carrier system designed to~     enter the cells and help the body produce cytokines.~      This study has two purposes; the first is to determine what different strengths of EGEN-001~     can be given safely without major side effects, and the second is to see if EGEN-001 is able~     to slow down the growth of ovarian cancer.~   "
260654|NCT00137852|"~     This is a study for patients with resectable, locally advanced esophageal cancer. There is~     evidence to suggest that celecoxib in combination with cisplatin and irinotecan (CPT-11) may~     work well with radiation therapy to kill cancer cells. The primary goal is to develop a~     well-tolerated cancer treatment that has an acceptable response rate.~   "
260658|NCT00137800|"~     The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and~     potentially as good as or better than standard chemotherapy drugs, when given to subjects~     with non-small cell lung cancer, who are 70 years of age or older.~   "
260659|NCT00137787|"~     The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as~     cefepime for the initial treatment of febrile neutropenia developed in patients with~     hematologic diseases.~   "
260660|NCT00137774|"~     The purpose of this study is to determine what effects (good and bad) bevacizumab and~     temozolomide have on patients with neuroendocrine tumors.~   "
260661|NCT00137761|"~     The purpose of this study is to find out what activity the combination of docetaxel and~     Iressa have against metastatic pancreatic cancer.~   "
260662|NCT00137748|"~     This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the~     Cleveland Clinic Foundation who are hypogammaglobulinemic.~   "
260663|NCT00137735|"~     The purpose of this study is to determine whether gabapentin is safe and effective in the~     treatment of carpal tunnel syndrome (CTS).~   "
260664|NCT00137722|"~     Disease management is used to manage patients who have asthma and who are enrolled in a~     managed care health plan. To understand the effect of disease management on asthma severity~     and utilization, the investigators at Children's Mercy Hospitals and Clinics, will review~     data from a Medicaid Health Maintenance Organization (HMO) to determine the number of health~     plan members with different asthma severities and what their outcomes are. This will help us~     to improve the service provided to these patients. The investigators wish to publish this so~     that other health plans can benefit from the investigators experience.~   "
260665|NCT00137709|"~     Both sodium valproate and lamotrigine are currently used in the treatment of newly diagnosed~     epilepsy. Although they appear to have similar efficacy, they have different side effects,~     which have not been well studied. This study aims to compare one particular aspect of their~     possible side effects, namely whether they affect certain hormonal functions.~   "
260666|NCT00137696|"~     As poliovirus eradication progresses rapidly, strategies to discontinue oral poliovirus~     vaccination need to be established. One strategy would be to use inactivated poliovirus~     vaccine (IPV) transitionally, and this has already occurred in the United States. It is not~     clear, however, if 3 doses of IPV provide sufficient immunogenicity when administered~     according to World Health Organization (WHO)/Expanded Programme on Immunization (EPI)~     schedule in a tropical, developing area where no wild-poliovirus circulates.~      Puerto Rico will be the study site for this randomized clinical trial. Healthy infants will~     be identified at birth in a hospital-system, enrolled within 4 weeks of birth, and randomized~     into one of two arms: United States of America (U.S.A.) schedule (8, 16, 24 weeks/2, 4, 6~     months) or WHO schedule (6, 10, 14 weeks). Both groups will receive IPV at visits 1, 2 and 3.~     Infants will receive all age-appropriate EPI childhood vaccinations along with IPV, to~     decrease confusion and inconvenience to the parent. Serum will be collected twice, at visit 1~     and visit 4 (30-45 days after IPV-3), to measure antibody titers. Sera will be measured for~     neutralizing antibodies at the Centers for Disease Control (CDC). Based on the lowest~     seroconversion rate estimate of 85%, and to have a probability of .80 that the estimate from~     this study is in error by no more than 10%, the investigators will need to enroll 220 infants~     in each arm. To compensate for attrition and retain statistical power, the investigators plan~     to enroll up to 250 infants in each arm. This study is expected to require at least 20 months~     to complete. Results will provide valuable and timely information applicable to global polio~     eradication efforts. Any participant found not to be protected after 3 doses of IPV will be~     given a booster at 9-12 months. Results will provide valuable and timely information~     applicable to global polio eradication efforts.~   "
260667|NCT00137683|"~     The purpose of this project is to conduct a community-based intervention and evaluate the~     independent and combined effects of two intervention strategies on primary and secondary~     prevention of colorectal cancer (CRC) among members of rural Appalachian churches. The~     sampling frame consists of all of the churches in a 7 county area of western West Virginia.~     Eligible churches will have at least 180 active members, will not share a common pastor, and~     will have no CRC control activities. Using a 2x2 experimental design, churches will be~     divided into two separate clusters, those with and without an existing parish nurse program.~     Then churches from each cluster will be randomized to one of two conditions, a natural helper~     or a control condition.~   "
260668|NCT00137670|"~     The purpose of this study is to assess the effectiveness of a brief 23-minute video-based~     educational waiting room intervention to reduce incident STD and high risk behavior among STD~     patients attending STD clinics in three United States (U.S.) cities.~   "
260669|NCT00137657|"~     At least three studies in sub-Saharan Africa have demonstrated a decrease in morbidity or~     mortality among HIV-infected adults who took daily cotrimoxazole (trimethoprim~     sulfamethoxazole) [CTX] prophylaxis. Because of the demonstrated beneficial effect, high~     tolerability and low cost of CTX, the United Nations Programme on HIV/AIDS (UNAIDS)~     recommends that HIV-infected persons with symptomatic HIV or depressed CD4 counts receive~     daily CTX. The effect of this recommendation on subsequent development of antimicrobial~     resistance to antifolates among important pathogens needs to be evaluated. The investigators~     measured the change in the prevalence of markers of antifolate resistance among P.~     falciparum, and the change in the prevalence of CTX resistance among S. pneumoniae, and E.~     coli in HIV-infected individuals receiving CTX daily prophylaxis. In addition, the~     investigators measured the change in the prevalence of naso-pharyngeal or oro-pharyngeal~     carriage of CTX resistant S. pneumoniae among children living in households where an~     HIV-infected adult was receiving CTX daily prophylaxis.~   "
260670|NCT00137644|"~     The purpose of this program evaluation is to determine whether the Preventing AIDS Through~     Live Movement and Sound (PALMS) group-level intervention is effective in reducing HIV sex~     risk behaviors and increasing HIV testing of high-risk, incarcerated or adjudicated youth.~     The intent of this program is to support the evaluation of an existing intervention and~     provide feedback to the implementing organization for improved program effectiveness, not to~     conduct research.~   "
260671|NCT00137631|"~     The purpose of this program evaluation is to determine whether the Many Men, Many Voices~     HIV/STD prevention intervention is effective in reducing HIV sex risk behaviors and~     increasing HIV testing among African-American men who have sex with men (MSM), who may or may~     not self-identify as gay. The intent of this program is to support the evaluation of an~     existing intervention and provide feedback to the implementing organization for improved~     program effectiveness, not to conduct research.~   "
260711|NCT00137111|"~     The primary objective is to estimate the overall event-free survival of children at least one~     year of age at diagnosis who are treated with risk-directed therapy and to monitor the~     molecular remission induction rate.~   "
260672|NCT00137618|"~     This project is a community based participatory research collaboration that will enable~     increased informed decision making (IDM) for prostate cancer screening in Hispanic and~     African-American men. This will be done through the development of an educational program~     implemented in the communities of El Paso, Texas and Columbia, South Carolina to provide~     accurate information to men regarding prostate cancer screening in order to enable them to~     make informed decisions.~   "
260673|NCT00137605|"~     The purpose of this study is to determine whether people who are HIV-positive respond better~     to a vaccine for pneumonia-related disease when they are immunized immediately, or when~     immunization is delayed until the immune system has improved to a certain level. The study~     will also compare the effectiveness of polysaccharide and heptavalent vaccines.~   "
260674|NCT00137592|"~     This community based participatory research study involves multicomponent educational~     interventions. Telephone interviews and focus groups of persons who are residents of the High~     Plains region of Colorado will be conducted. A card study will also be carried out to collect~     limited data about colorectal cancer screening in primary care practices. The multicomponent~     intervention approaches (e.g., small media and group education) consist of educational~     materials about routine colorectal cancer screening.~   "
260675|NCT00137579|"~     Until now, the best administration route of the anti-flu vaccine for patients receiving long~     term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has~     not been recommended because it may increase the risk of muscular haematoma. Although this~     practice is widely extended, no significant differences between the safety of both routes~     have been found. Some authors, analysing a small group of patients, affirm that the anti-flu~     vaccine can be administered safely by the intramuscular route on patients receiving long term~     oral anticoagulation therapy, while a previous opinion article recommended the subcutaneous~     route without any scientific evidence. Due to this, the investigators have done a clinical~     trial with the aim of determining the safety and effectiveness of the flu-vaccine~     intramuscular route in patients receiving long term oral anticoagulation therapy and also to~     analyse the possible interactions between the vaccine and the oral anticoagulant treatment.~   "
260676|NCT00137566|"~     The National Malaria Programme in Guinea-Bissau recommends paracetamol for all children~     treated for malaria. We, the investigators of the Bandim Health Project, want to evaluate~     whether this treatment has any effect on:~        -  the well-being of the child;~        -  the parasite clearance time; and~        -  the rate of a re-appearance of parasites during 35 days of follow-up.~      Children presenting at Bandim Health Centre with malaria will be treated with chloroquine~     plus paracetamol or chloroquine plus placebo. Blood samples will be obtained daily for the~     first 4 days and then once a week until day 35.~   "
260677|NCT00137553|"~     Children participating in a study evaluating the efficacy of chloroquine and amodiaquine for~     the treatment of malaria will, if getting malaria during follow-up, be re-treated with~     sulfadoxine-pyrimethamine (SP) in accordance with the recommendations of the National Malaria~     Programme.~      To compare the actual efficacy of SP with that in 1995 - 1996 we, the investigators of the~     Bandim Health Project, will visit these children once a week for 5 weeks. A finger prick~     blood sample will be collected for a malaria test.~      Children with malaria during follow-up will be treated according to the guidelines of the~     Bandim Health Centre.~   "
260678|NCT00137540|"~     The objective of this multicenter randomized study is to establish the effectiveness of~     treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with~     anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation,~     using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness~     will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic~     drug treatment, defined as patients with an absence of atrial tachycardias during 24 months~     of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead~     electrocardiogram (ECG) recordings.~   "
260679|NCT00137527|"~     The purpose of this study is to determine whether intraoperative brain oxygenation monitoring~     in cardiac surgery patients is effective in reducing postoperative neurologic and~     neurocognitive dysfunction.~   "
260680|NCT00137514|"~     This study will evaluate the efficacy of the treatment recommended by the National Malaria~     Programme in Guinea-Bissau as compared to a higher dose of chloroquine and to another~     anti-malarial drug, amodiaquine. The genetic basis of the parasites for developing resistance~     will be examined. Children coming to Bandim Health Centre with symptoms of malaria and a~     positive malaria test will be included. The children will be visited and malaria films will~     be obtained weekly until day 35. In case of a reappearance of parasites the children will be~     re-treated with sulfadoxine/pyrimethamine.~   "
260681|NCT00137501|"~     Preterm birth is one of the most important causes of perinatal morbidity and mortality~     worldwide. Prevention and treatment of preterm labor is important, not as an end in itself,~     but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs~     used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most~     widely used tocolytic at the American University of Beirut Medical Center despite the fact~     that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently~     available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm~     labor to the extent that some authorities are recommending abandoning it for routine use as a~     tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in~     smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe~     alternative tocolytic agent for the management of preterm labor after several studies have~     shown that the use of nifedipine in comparison with other tocolytics is associated with a~     more frequent successful prolongation of pregnancy, resulting in significantly fewer~     admissions of newborns to the neonatal intensive care unit, and is associated with a lower~     incidence of respiratory distress syndrome. The unequivocal impact of this method of~     tocolysis on short term postponement of delivery and the opportunity that this provides for~     affecting in-utero transfer and steroid administration has prompted many investigators to~     recommend focusing future trials on testing different dose regimens of nifedipine. To the~     best of the investigators' knowledge, no study comparing two different dose regimens of~     nifedipine has been previously published in the literature. The objective of their study is~     to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients~     admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In~     addition, the investigators' study will try to assess the safety profile of the 2 dose~     regimens on the mother and the neonate by assessing a selected number of outcome variables.~     The data generated will be used to change their protocol for managing patients presenting~     with threatened preterm delivery and will fill the existing gap regarding the most effective~     and safest dose regimen of nifedipine in such patients.~   "
260769|NCT00136357|"~     The purpose of this study is to determine whether the participation in a group program which~     includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of~     movement and breathing techniques will decrease symptoms of posttraumatic stress in high~     school students.~   "
260682|NCT00137488|"~     The low grade glioma (LGG) is a type of brain tumor which is generally more common in younger~     age group patients. Most patients with LGG undergo surgery which is mostly incomplete due to~     concern about loss of function. This is an incurable disease. More than half of these~     patients progress to a higher grade with a worse outcome within five years of their diagnosis~     and only one-third survive for up to ten years. Post-operative radiation treatment improves~     local control without survival advantage. Efforts are being made without great success to~     select the patients with a higher risk of progression based on physical characteristics and~     histological features.~      Tumor vascularity is thought to be the key element in tumor progression. Tremendous progress~     has been made in functional imaging by using magnetic resonance imaging (MRI) 3-Tesla (3T)~     and in biotechnology which can be used to investigate angiogenic gene profiles in order to~     identify gene signature for these tumors. In this study the investigators are proposing that~     patients of LGG with a higher risk of tumor progression may be selected by functional imaging~     and angiogenic profiles. These higher risk patients may be candidates for post-operative~     radiation in the future with a potential survival benefit.~   "
260683|NCT00137475|"~     Radiotherapy is the primary treatment modality or an important adjunct treatment for many~     patients with H&N carcinoma. Local control is directly related to dose and to the technical~     accuracy with which the dose is delivered to the target volume. Traditional radiotherapy~     techniques result in significant doses being delivered to normal tissues adjacent to the~     target, including the spinal cord and salivary glands. This leaves the patient with~     significant acute and late normal tissue toxicity that impacts on both the ability to~     tolerate the actual treatment and on the patient's long-term quality of life. Recently, the~     investigators have used static conformal multisegmental intensity modulated radiotherapy~     (IMRT) for a comprehensive irradiation of head and neck cancer with dose sparing of~     uninvolved tissues. This has resulted in substantial preservation of major salivary gland~     function in many patients with primary sites in the oral pharynx, oral cavity, nasopharynx,~     and pyriform sinus. While the investigators' results to date have shown promising~     preservation of salivary flow, they do not know whether patients treated with IMRT have~     similar local control rates as those treated with standard radiotherapy. Some investigators~     have raised the concern that by giving a low radiation dose to areas adjacent to the target~     volume there is a risk of undertreating the disease. On the other hand, the IMRT delivered~     with this protocol (called simultaneous integrated boost, or SIB) may improve local control~     rates by delivering the same biologically effective dose in a shorter overall time period.~     This is a phase I/II trial which seeks to establish the efficacy of IMRT for H&N cancer~     treatment, and to further investigate the relationship between radiation dose to the parotid~     glands, salivary flow, and quality of life.~   "
260684|NCT00137462|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed~     dyslipidemias~   "
260685|NCT00137449|"~     To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant~     gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule~   "
260686|NCT00137436|"~     This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in~     combination with docetaxel and prednisone for the first-line treatment of metastatic~     hormone-refractory prostate cancer (mHRPC).~   "
260687|NCT00137423|"~     To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic~     renal cell carcinoma (RCC) when administered in a continuous treatment regimen~   "
260688|NCT00137410|"~     This is a phase III, multicentre, randomized, double blind, parallel-group, pilot study~     designed to compare a long term (12 weeks) versus a short term (2 weeks) treatment with~     celecoxib 200 mg/die in treatment and prevention of new flare in patients with osteoarthritis~     of the knee.~   "
260689|NCT00137397|"~     The main aim of the study is to investigate whether taking Tolterodine for overactive bladder~     symptoms can reduce the thickness of the bladder wall, as measured by intra-vaginal~     ultrasound. This will help doctors to understand whether there is a link between changes in~     the thickness of the bladder wall and progression of symptoms.~   "
260690|NCT00137384|"~     This study will use various methods to measure the activity of the motor cortex (the part of~     the brain that controls movements) in order to learn more about focal hand dystonia. Patients~     with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or~     abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or~     face, is involved.~      Patients with focal hand dystonia and healthy normal volunteers between 18 and 65 years of~     age may be eligible for this study. Each candidate is screened with a medical history,~     physical examination and questionnaire. Participants undergo the following procedures:~      Finger Movement Tasks~      Subjects perform two finger movement tasks. In the first part of the study, they move their~     index finger repetitively from side to side at 10-second intervals for a total of 200~     movements in four blocks of 50 at a time. In the second part of the study, subjects touch~     their thumb to the other four fingers in sequence from 1, 2, 3 and 4, while a metronome beats~     2 times per second to help time the movements. This sequence is repeated for a total of 200~     movements in four blocks of 50 at a time.~      Electroencephalography~      This test records brain waves. Electrodes (metal discs) are placed on the scalp with an~     electrode cap, a paste or a glue-like substance. The spaces between the electrodes and the~     scalp are filled with a gel that conducts electrical activity. Brain waves are recorded while~     the subject performs a finger movement task, as described above.~      Magnetoencephalography~      MEG records magnetic field changes produced by brain activity. During the test, the subjects~     are seated in the MEG recording room and a cone containing magnetic field detectors is~     lowered onto their head. The recording may be made while the subject performs a finger task.~      Electromyography~      Electromyography (EMG) measures the electrical activity of muscles. This study uses surface~     EMG, in which small metal disks filled with a conductive gel are taped to the skin on the~     finger.~      Magnetic resonance imaging~      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The~     patient lies on a table that can slide in and out of the scanner (a narrow metal cylinder),~     wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning.~     Most scans last between 45 and 90 minutes. Subjects may be asked to lie still for up to 30~     minutes at a time, and can communicate with the MRI staff at all times during the procedure.~      Questionnaire~      This questionnaire is designed to detect any sources of discomfort the subject may have~     experienced during the study.~   "
260691|NCT00137371|"~     This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated~     estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.~   "
260692|NCT00137358|"~     Investigator has since decided not to pursue this protocol further. No patients were~     enrolled.~      This study is to determine the maximum tolerated dose of external beam radiation to the~     para-aortic lymph nodes using intensity modulated radiation therapy (IMRT).~      This protocol will test the hypothesis that the use of IMRT and amifostine will decrease GI~     toxicity and therefore allow the radiation dose to the para-aortic lymph nodes to be safely~     escalated.~   "
260693|NCT00137345|"~     The purpose of this study is to determine if one drug is superior to another with regard to~     safety and the preservation of renal function after a kidney transplant.~   "
260696|NCT00137306|"~     Comorbid depression has been consistently linked to worse outcomes for patients in substance~     abuse treatment programs. Practice guidelines recommend pharmacotherapy for comorbid~     depression if symptoms persist after a 4-week wash-out period for detoxification (e.g.,~     Veterans Health Administration; American Psychiatric Association). Medications may be~     considered earlier if a patient has current symptoms and a history of major depressive~     disorder (MDD) during periods of sobriety. Current efficacy data suggest that antidepressant~     medication can improve both depression and substance use outcomes among comorbid patients~     Guideline-concordant use of antidepressant medication for persons with comorbid substance use~     and depressive disorders, however, is not routine in many VA substance abuse treatment~     settings.~   "
260697|NCT00137293|"~     The purpose of this study is to learn the effects of a test drug on heart rhythm, and to~     provide additional data to see if the test drug is well tolerated and safe.~   "
260698|NCT00137280|"~     This project evaluates the implementation and effectiveness of a care model to improve~     treatment for schizophrenia within the context of diverse VA practices and priorities. The~     project provides information to VA clinicians and managers about Veterans with schizophrenia~     or schizoaffective disorder who are overweight and/or who would like to return to competitive~     work. The project facilitates reorganization of care practices in order to get veterans~     needed and desired services around wellness and work. The project creates a platform that~     other clinical and research interventions can build upon to improve care, and is designed to~     inform a national strategy for implementing evidence-based care in schizophrenia.~   "
260699|NCT00137267|"~     Surveys suggest that up to 80% of veterans with a persistent mental illness have a~     co-occurring substance use disorder. Substance abuse among this population is problematic and~     often results in poor engagement in treatment and thus, frequent hospitalizations and an~     unstable illness course. Regarding treatment engagement, data from a VA New Jersey facility~     indicated that 50% of those veterans discharged from the acute psychiatric hospital unit to~     outpatient care did not attend their initial screening appointment and another 30% dropped~     out within six weeks. To assist with the transition from inpatient to outpatient care, we~     previously developed an eight-week augmentation intervention entitled, Time-Limited Case~     Management (TLC). TLC integrates evidence-based interventions of 1) Dual Recovery Therapy; 2)~     Critical Time Intervention Case Management along with 3) Peer Support with the goal of~     assisting individuals with the transition from inpatient to outpatient care.~   "
260700|NCT00137254|"~     The purpose of this study is to examine the effects of insulin on helping burn patients~     recover faster from their burns.~   "
260701|NCT00137241|"~     The primary objectives for this study are to develop an estimate of the prevalence of health~     literacy at four geographically diverse Veterans Affairs Medical Centers (Minneapolis,~     Portland, Durham, and West Los Angeles), and for specific groups based on age, race,~     education, and geographic location. The investigators' secondary objectives are to illustrate~     the potential significance of poor health literacy by linking estimates for those over 50~     years old to colorectal cancer (CRC) screening data and examining variation in screening~     rates by health literacy levels. The investigators expect that people with lower health~     literacy skills will be less adherent to CRC screening guidelines.~   "
260702|NCT00137228|"~     The purpose of this study is to determine the reliability and concurrent validity of the~     figure-of-eight method of measuring hand edema in the burn patient population. Establishing~     the reliability and validity would enable a more time efficient assessment than the currently~     accepted methods.~   "
260703|NCT00137215|"~     The purpose of this study is to compare one type of dressing against the current standard~     dressing that is used to cover an unburned area of the skin where a piece of skin is removed~     to cover another part of the body that was burned.~      Hypothesis: The mean healing time for wounds treated with the Silverlon Dressing will be less~     than the mean healing time for wounds treated with Xeroform Dressing.~   "
260704|NCT00137202|"~     The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching~     from healing burn wounds as well or better than the usual drug used, diphenhydramine~     (Benadryl).~   "
260705|NCT00137189|"~     The aim of this study is to examine whether resource-oriented music therapy helps psychiatric~     patients with low therapy motivation to improve negative symptoms and other health-related~     outcomes.~   "
260706|NCT00137176|"~     The primary purpose is to determine the changes in gene expression induced by IFNb-1a (Rebif)~     and atorvastatin (Lipitor) combination therapy in patients with an isolated clinical syndrome~     suggestive of multiple sclerosis (MS), to identify markers of therapeutic response, and to~     predict patients' clinical response based on their in vitro response to this combination~     therapy measured by the gene expression levels in activated peripheral blood mononuclear~     cells (PBMCs).~   "
260707|NCT00137163|"~     The purpose of the study is to compare one type of dressing against the current standard~     dressing that is used to cover the unburned area of the skin where a piece of skin is removed~     to cover another part of the body that was burned.~      Hypothesis: The mean healing time for wounds treated with the Dermafill dressing will be less~     than the mean healing time for wounds treated with Xeroform dressing.~   "
260708|NCT00137150|"~     This study is a comparison of outcome and complications encountered in flapless surgery and~     immediate loading versus the classical surgical approach and loading after 6-8 weeks in the~     posterior maxilla.~   "
260709|NCT00137137|"~     This is a clinical trial to evaluate the mini-screw as orthodontic anchoring. This trial will~     study implant survival, clinical efficiency and experience of the patient.~   "
260710|NCT00137124|"~     Essential hypertension is characterized by impaired endothelial function. Data derived from~     normotensive subjects with a genetic predisposition to arterial hypertension suggest that~     endothelial dysfunction is a cause rather than a consequence of the condition. Given that, in~     normotensive offspring of hypertensive parents, impaired endothelium dependent vasodilation~     can be restored by supplementation of the nitric oxide (NO) precursor L-arginine, a defect in~     the L-arginine/NO pathway can be postulated. The investigators at the University of~     Erlangen-Nuremberg, hypothesize that impaired endothelial function in essential hypertension~     is associated with alterations in L-arginine metabolism and transport. This study will~     determine whether metabolism and transport of L-arginine are altered in patients with~     essential hypertension and whether these potential alterations can be targeted~     therapeutically.~   "
260712|NCT00137098|"~     Sudden cardiac death due to a heart rhythm disturbance after a heart attack (myocardial~     infarction) is a common cause of death. It is well documented that sudden cardiac death after~     a myocardial infarct (MI) is associated with low or poor heart rate variability (HRV). HRV is~     a measure of beat-to-beat changes in heart rate, with a greater variation associated with a~     healthier heart. The effect of caffeine on HRV in patients at high risk for sudden cardiac~     death is unknown. We, the investigators at the Royal Bournemouth Hospital, aim to study the~     effect of coffee or tea on HRV after MI.~   "
260713|NCT00137085|"~     We, the investigators at Queen's University, propose to conduct a randomized, double-blind,~     feasibility trial comparing low-dose ketamine versus fentanyl as adjuncts to Emergency~     Department procedural sedation with propofol. The outcomes of interest will be safety, with~     respect to hemodynamic and respiratory adverse effects, as well as efficacy, with respect to~     adequacy of sedation and analgesia, recovery profiles and patient/physician satisfaction. Our~     hypothesis, based on a review of existing anesthesia literature, is that low-dose ketamine~     may be a safer and more efficacious alternative to fentanyl when used as an adjunct to~     propofol-assisted procedural sedation.~   "
260714|NCT00137072|"~     Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile~     dysfunction~   "
260715|NCT00137059|"~     It is widely believed that people who abuse alcohol can sustain a liver injury after taking~     doses of acetaminophen just above the recommended maximum dose. This study is designed to~     look at the interaction between acetaminophen, liver injury and alcohol abuse. Subjects will~     undergo baseline tests to ensure that they do not have liver damage at the time of~     enrollment. Each subject will be randomly assigned to receive either a therapeutic dose of~     acetaminophen or a placebo three times a day for four days. Subjects will have blood work~     drawn on a daily basis to monitor the status of the liver. These tests will include~     conventional markers of liver injury in addition to a novel biomarker of liver function,~     a-GST. Previous work in the investigators' group has shown that a-GST is a more sensitive~     indicator of liver injury following acetaminophen overdose (Sivilotti 1999, Sivilotti 2002 x~     2). However, it has never been used to study the alcoholic population. The investigators~     believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has~     previously gone unrecognized in the alcoholic population.~   "
260716|NCT00137046|"~     This study is being done to find out the good and bad effects of a drug that is not approved~     for sale and the effects if any on measures of pulmonary function in adult males and females~     with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).~      This study included a 2-year comparative treatment period followed by a 6-month follow-up~     period during which inhaled insulin-treated subjects were switched back to subcutaneous~     short-acting insulin. After this follow-up period, all eligible subjects entered a~     comparative extension period that was to last for 5 years. When the comparative portion of~     the study was terminated, all subjects were requested to return for a final extension~     follow-up month 3 visit.~   "
260717|NCT00137033|"~     The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US~     setting, using a lower dose of ASA. It is expected that this study will not only confirm the~     results of the 258 study but show that the incidence of UGI ulcers on celecoxib is~     significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib~     increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus~     ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers~     associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg~     BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).~   "
260718|NCT00137020|"~     The primary objective is to compare effectiveness of ziprasidone treatment to current~     treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric~     Rating Scale (BPRS) scores versus baseline~   "
260719|NCT00137007|"~     The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is~     consistent with current guidelines for the treatment of CAP. In fact the International~     guidelines for the treatment of CAP in hospitalised patients suggests the use of a~     combination between a b-lactam and a macrolide.~      This trial will allow investigators to evaluate the efficacy of azithromycin plus~     ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired~     pneumonia. In addition, this trial will allow investigators to evaluate the safety and~     toleration of combination therapy.~   "
260720|NCT00136994|"~     To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with~     acute exacerbation of schizophrenia~   "
260721|NCT00136981|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To look at ultrasound images taken in the carotid arteries and to look at various lipids in~     the blood of people with heterozygous familial hypercholesterolemia~   "
260722|NCT00136968|"~     The purpose of this study is to determine the amount of voriconazole in the brain by~     fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.~   "
260723|NCT00136955|"~     The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin~     as first-line chemotherapy for advanced or recurrent cervical cancer~   "
260724|NCT00136942|"~     The proportion of patients achieving LDL-C target as defined by Swiss cholesterol~     recommendations (AGLA-recommendations) across starting doses of 10 mg, 20 mg, 40 mg, and 80~     mg of atorvastatin.~   "
260725|NCT00136929|"~     This is a prospective, randomized, multi-center, international trial comparing two~     reperfusion strategies in elderly (age >= 70 years) patients with acute myocardial~     infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic~     therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1~     year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study~     null hypothesis is that there will be no significant difference in death or disabling stroke~     at 30 days post-randomization between patients treated with PCI versus thrombolytics.~   "
260749|NCT00136617|"~     The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered~     therapy for alcohol withdrawal syndrome in medical outpatients.~      Objectives:~        -  Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication~        -  Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal~          syndrome~        -  Outpatient treatment of alcohol withdrawal syndrome~   "
260726|NCT00136916|"~     This study is being done to find out the good and bad effects of inhaled insulin that is used~     by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name~     for this inhaled insulin is Exubera®.~      This study included a 2-year comparative treatment period followed by a 6-month follow-up~     period during which inhaled insulin-treated subjects were switched back to subcutaneous~     short-acting insulin. After this follow-up period, all eligible subjects entered a~     comparative extension period that was to last for 5 years. When the comparative portion of~     the study was terminated, all subjects were requested to return for a final extension~     follow-up month 3 visit.~   "
260727|NCT00136903|"~     To establish the safety and efficacy of two dose levels of Ex-vivo Cultured Adult~     HumanMesenchymal Stem Cells (Prochymal) in subjects experiencing acute GVHD, Grades~     II-IV,post HSC transplant.~   "
260728|NCT00136890|"~     Lung cancer remains the leading cause of cancer deaths in men and women. Although overall~     survival remains poor, early stage non-small cell lung cancer (NSCLC) is potentially curable.~     Improved staging has led to stage-specific therapies such that patients with early stage~     NSCLC are potential candidates for surgical resection, and those with more advanced disease~     are spared the morbidity and risk of mortality from thoracotomy and pulmonary resection.~     Despite contemporary staging techniques, 25-50% of patients who appear to have limited~     disease amenable to surgical resection go on to die from metastatic lung cancer. If occult~     micro-metastatic disease that becomes evident later could be detected reliably during the~     pre-operative assessment, patients harboring such disease could be spared a non-curative~     thoracotomy. PET imaging has the potential to detect mediastinal and extrathoracic metastatic~     disease not detected by conventional imaging modalities.~      This prospective, multicenter trial will enroll patients with biopsy-proven clinical stage~     I-IIIA NSCLC who are considered to be candidates for surgical resection with curative intent.~     Preoperatively, patients will be randomized to conventional staging for metastatic disease~     (CT liver/adrenals, total body bone scan, and CT with contrast or MRI with gadolinium of the~     brain) versus whole body PET or PET-CT and brain CT or MRI with contrast/gadolinium.~   "
260729|NCT00136877|"~     The purpose of this study is to determine whether tonsillectomy is effective in preventing~     further streptococcal pharyngitis episodes in patients with recurrent tonsillitis.~   "
260730|NCT00136864|"~     Locally advanced non-small cell lung cancer, NSCLC, (Stage III) is potentially curable with~     aggressive combined modality therapy (chemotherapy and radiation). Conventional imaging can~     only evaluate gross anatomic abnormalities but functional imaging with positron emission~     tomography (PET) may more accurately identify patients who will benefit from aggressive~     combined modality therapy.~      This prospective randomized clinical trial will enroll 400 patients that have undergone~     conventional staging for lung cancer and have been found to have Stage III NSCLC. The~     patients will then be randomized to either standard combined modality therapy for Stage III~     NSCLC or to PET imaging prior to combined modality therapy with curative intent. Based on the~     PET findings, patients will either be suitable for combined modality therapy with curative~     intent or not.~   "
260731|NCT00136851|"~     This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment~     regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.~   "
260732|NCT00136838|"~     Recent research on the effects of nicotine on the brain and behavior presents an opportunity~     to advance medication development.~      The purpose of this study is to develop a laboratory model for early-stage testing of new and~     existing treatments for nicotine addiction. Specifically, the investigators will develop a~     laboratory model of relapse to cigarette use in nicotine dependent volunteers.~   "
260733|NCT00136825|"~     Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces cocaine~     drug-seeking behavior in formerly cocaine dependent rats. The purpose of this study is to~     determine the safety, tolerability, and cue reactivity effects of NAC in cocaine dependent~     individuals and non-dependent healthy controls.~   "
260734|NCT00136812|"~     The purpose of this study is to test in a randomized clinical trial a series of hypotheses~     concerning the efficacy of an extended expert-system intervention plus nicotine replacement~     therapy (NRT) for treating tobacco dependence among patients hospitalized on a smoke-free~     psychiatric unit.~   "
260735|NCT00136799|"~     The purpose of the study is to evaluate the safety and tolerability of fluvastatin 80 mg in a~     Chinese population. This study is not recruiting patients in the US.~   "
260736|NCT00136786|"~     One of nicotine's effects on the body is at the level of the NMDA receptors in the brain.~     Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment~     of nicotine addiction. The purpose of this study is to evaluate the effectiveness of~     memantine using a laboratory model of smoking relapse in nicotine dependent volunteers.~     Investigators will compare the effects of memantine with bupropion, medication currently used~     to facilitate smoking cessation.~   "
260737|NCT00136773|"~     Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk~     factor for kidney disease. Aggressive blood pressure reduction is an important strategy to~     protect the kidney and reduce urinary protein which develops with kidney disease. This study~     will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary~     protein in hypertensive subjects with type 2 diabetes mellitus.~   "
260738|NCT00136760|"~     There is a high prevalence of smoking among people with schizophrenia, and there are few~     smoking treatment programs for these smokers. The aims of this study are to investigate the~     separate and combined effects of bupropion and a voucher incentive program on smoking in~     people with schizophrenia.~   "
260739|NCT00136747|"~     One of nicotine's effects on the body is at the level of the NMDA receptors in the brain.~     Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment~     of nicotine addiction. The purpose of this study is to evaluate the effectiveness of~     memantine using a laboratory model of tobacco addiction. The investigators will compare the~     effects of memantine with bupropion, medication currently used to facilitate smoking~     cessation.~   "
260740|NCT00136734|"~     Many cocaine dependent individuals are also diagnosed with Attention Deficit Hyperactivity~     Disorder (ADHD). Methylphenidate (Ritalin) is currently approved to treat individuals~     diagnosed with ADHD. The purpose of this study is to determine the effectiveness of~     methylphenidate in treating ADHD symptoms in cocaine dependent individuals.~   "
260741|NCT00136721|"~     Parkinson's disease (PD) is the most frequent neurodegenerative disease with a prevalence of~     2% over 65 years and because of this high prevalence as the population ages, it is a major~     problem of public health.~      An exhaustive repertory of not only parkin mutations in autosomal recessive forms of PD but~     also in other known genes such as DJ-1, PINK1 and LRRK2, is of major importance for both~     genetic counseling in families affected with PD and physiopathological approaches to this~     disease.~      Through a French network for the study of Parkinson's disease genetics and extended~     collaborations with European, Mediterranean and other various countries, a total of 2934~     subjects including 1683 patients and 1251 unaffected individuals has been collected since~     2002. These samples consisted of 122 families with autosomal recessive PD, 285 cases of~     isolated early onset PD, 110 autosomal recessive and 129 autosomal dominant families with~     late onset PD, 201 isolated late onset PD cases and 250 matched controls.~      DNAs from all subjects are now available, lymphocytes and lymphoblastoid cell lines have been~     stored for most patients from France and recently, fresh fibroblasts have been obtained for~     some individuals.~      The genetic approach to autosomal recessive PD is focused on the identification of mutations~     in the parkin gene but also on the screening of DJ-1, PINK1 and LRRK2 genes.~   "
260742|NCT00136708|"~     In developing countries, neonatal death from birth asphyxia is a major problem. This study~     will be conducted in several countries to determine if the combined Neonatal Resuscitation~     Program/Essential Newborn Care Program compared to the new World Health Organization (WHO)~     basic perinatal care education of health care providers (Essential Newborn Care Program)~     results in reduced mortality due to perinatal asphyxia.~   "
260743|NCT00136695|"~     The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to~     reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex~     hormones).~   "
260744|NCT00136682|"~     Recovery after major abdominal surgery can be longer than other types of surgery. This is~     because often after abdominal surgery, the bowel does not work normally. When this happens,~     patients are unable to pass gas. This can lead to bloating, pain, nausea and vomiting. These~     symptoms are called postoperative ileus.~      We, the researchers at Memorial Sloan-Kettering Cancer Center (MSKCC), are doing this study~     to compare two methods of treating pain during and after major gynecological surgery. The two~     methods are called patient-controlled epidural analgesia (PCEA) and patient-controlled~     intravenous analgesia (PCA). PCA is the standard of care for women having major gynecological~     surgery. We are going to compare PCEA to PCA to see if PCEA will improve recovery after major~     gynecologic surgery.~      PCEA is a well established method used to ease pain in many settings such as during~     childbirth and bowel surgery. There have been several studies showing that PCEA is as good as~     and sometimes better for pain relief than PCA. PCEA may help the bowel work better by~     preventing ileus after surgery. However, this has never been looked at in women having major~     gynecologic surgery. This study will also look at whether preventing this ileus will lead to~     patients going home or returning to regular activities sooner.~   "
260745|NCT00136669|"~     Pain is a common problem in patients with pancreatic cancer. Some patients suffer from pain~     despite medication. We, the researchers at Memorial Sloan-Kettering Cancer Center, are~     conducting a Phase III study to determine the effects of acupuncture on pain in patients with~     pancreatic cancer. The purpose of a Phase III study is to determine whether or not a~     treatment is helpful. This study will include about 60 patients.~      Acupuncture is the insertion of very fine needles into the skin to treat symptoms. In recent~     years, researchers have found evidence that acupuncture is useful in treating a variety of~     conditions, including headache, nausea, and pain.~   "
260746|NCT00136656|"~     The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of~     cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by~     cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode.~      The investigators hypothesize that treatment with cefixime PO will allow no more renal scars~     than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3~     years old, 6 months after the first episode. If it is true, treatment will no longer need~     hospitalisation and the advantages for children, families and the health system will be very~     important.~   "
260747|NCT00136643|"~     The objectives of this clinical study are to evaluate the extended safety, tolerance and~     acceptability of a vaginal gel formulation when applied in 452 healthy women volunteers. This~     vaginal formulation was shown to be well tolerated in a previous smaller clinical study. The~     formulation is being developed as a microbicide for the prevention of sexually transmitted~     infections (STIs) including HIV.~   "
260748|NCT00136630|"~     The autosomal dominant spinocerebellar degenerations are a highly heterogeneous, clinically~     and genetically, group of rare diseases and of severe evolution. So far, the responsible~     genes for less than 50% of the cases are known and because of their rarity, there are no~     phenotype-genotype correlations and well-defined disease history.~      The aims of the project are to develop and validate quantitative tools of the cerebellar~     syndrome and of the spasticity, to establish links between the phenotype and the result of~     the molecular analysis, to identify new loci/genes responsible for these disorders, and to~     establish the natural history of the disease according to the genotype.~      To this end, a prospective and multicentric study is proposed for recruiting and evaluating,~     clinically, a cohort of 225 patients; 150 of them are already followed-up in the centers~     involved. A DNA collection will be set up in order to search for the implication of new loci~     and genes. A clinico-genetic database will be set up combining data from successive clinical~     evaluations and those of genotyping.~      This strategy will allow access to genetic counselling and molecular diagnosis (positive,~     presymptomatic or prenatal diagnoses), based on a rational strategy from phenotype-genotype~     correlations and the information concerning the relative frequency of the genes. The detailed~     description, with the help of new evaluation tools and of the follow-up of the natural~     history of the disease according to the genotype, constitutes a crucial step in the design of~     therapeutical trials in these orphan disorders. Furthermore, the regular follow-up by~     specialized centers will allow better care of the patients.~   "
260768|NCT00136370|"~     The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine~     administered to the birth canal during labour and newborn at delivery can protect a woman and~     her baby from bacterial infections after birth. If effective, this could be used as an~     inexpensive alternative to antibiotics to prevent newborn infections in resource-poor~     countries.~   "
260750|NCT00136604|"~     The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a~     booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15~     to 24 months of age primed with 3 doses of Tritanrix™-HepB/Hib-MenAC in study 100480.~     Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and~     reactogenicity of a dose of Mencevax™ ACWY given at 24 to 30 months will also be evaluated~     when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.~   "
260751|NCT00136591|"~     This is a prospective, randomized, sequential, international, multicentric, 2-arm,~     non-comparative, open-label, 2-stage clinical study to determine disease response rates to~     Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma.~      Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing~     convenience will be made in order to recommend a dose schedule for further clinical study.~   "
260752|NCT00136578|"~     The purpose of this study is to determine the dose regimen of Ispinesib in combination with~     carboplatin in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion~     and carboplatin is dosed by 30 minute intravenous infusion every 3 weeks (on the same day). A~     patient may continue to receive treatment as long as they are benefiting from the treatment.~     Blood samples will be taken at specific times to measure the amount of both drugs in your~     body at specific times after the drug is given. Blood samples will also be taken for lab~     tests such as complete blood counts and clinical chemistries. Physical exams will be~     performed before each treatment with Ispinesib. During the treatment phase, the patients will~     undergo regular assessments for safety and clinical response.~   "
260753|NCT00136565|"~     The purpose of this study is to determine the efficacy and the safety profile and toxicity of~     a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP~     [doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone]) in the treatment of~     previously untreated patients with peripheral T-cell lymphoma (PTCL).~   "
260754|NCT00136552|"~     The purpose of this study is to assess in a prospective multicentric study (Phase III) the~     introduction of a monoclonal antibody directed against B-cells associated with a standard~     therapy including chemotherapy and alpha-interferon in first line treatment of patients with~     a large tumor burden follicular lymphoma.~   "
260755|NCT00136539|"~     The purpose of this study is to determine the effectiveness and safety of administering~     Herceptin in combination with Taxol (paclitaxel) in the treatment of women with~     HER2-positive, early stage breast cancer prior to surgery.~   "
260756|NCT00136526|"~     This study is for men who have prostate cancer that has spread outside of the prostate gland~     and is no longer responding to hormone removal therapy. This study is designed to determine~     if a new drug combination will help to control the cancer. The medicines being used,~     docetaxel and diethylstilbestrol (DES), have been given to patients with prostate cancer and~     each drug has demonstrated activity in prostate cancer, either used alone or in other~     combinations. The objective of this study is to determine the effect of this drug combination~     on the prostate cancer and its response to disease progression.~   "
260757|NCT00136513|"~     The purpose of this study is to find a dose of SB-743921 in adult patients with solid tumors~     or lymphoma who have progressed on standard therapy or who have relapsed. SB-743921 is dosed~     by 1-hour intravenous infusion every 3 weeks. A patient may continue to receive treatment as~     long as they are benefiting from the treatment. Blood samples will be taken at specific times~     to measure the amount of the drug in your body at specific times after the drug is given.~     Blood samples will also be taken for lab tests such as complete blood counts and clinical~     chemistries. Physical exams will be performed before each treatment with SB-743921. During~     the treatment phase, the patients will undergo regular assessments for safety and clinical~     response.~   "
260758|NCT00136500|"~     CRiALS is an umbrella protocol through which people are recruited to participate in a range~     of research studies being conducted by the ALS Research Collaboration (ARC).~   "
260759|NCT00136487|"~     The purpose of this study is to learn the effects (both good and bad) that celecoxib has on~     prostate cancer and patients with prostate cancer. This study is looking at what effects~     celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate~     cancer. An increase or decrease in this level in the blood can indicate if a patient's~     prostate cancer is getting worse or better.~   "
260760|NCT00136474|"~     The purpose of this study is determine the effects (good and bad) amifostine has on~     radiation-induced side effects of lymphoma treatment.~   "
260761|NCT00136461|"~     The purpose of this study is to assess the effects of the combination of all-trans retinoic~     acid in combination with one of two schedules of Bryostatin 1 in patients with myelodysplasia~     and acute myelogenous leukemia.~   "
260762|NCT00136448|"~     This study will add interleukin-2 (IL-2) to a regimen of post-remission therapy consisting of~     high-dose ara-C. Patients with AML in first remission will receive 3 cycles of high-dose~     ara-C followed by continuous infusion and bolus interleukin-2 (IL-2). We, the researchers at~     the Dana-Farber Cancer Institute, plan to evaluate the immunologic effects of such treatment~     in these patients.~   "
260763|NCT00136435|"~     The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in~     adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.~   "
260764|NCT00136422|"~     The purpose of this study is to test the safety of a new investigational acute myeloblastic~     leukemia (AML) vaccine and see what effects (good and bad) it has on patients with advanced~     myelodysplasia or acute myelogenous leukemia.~   "
260765|NCT00136409|"~     The purpose of this study is to determine the effects (good and bad) of Gleevec in patients~     with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid~     metaplasia and chronic myelomonocytic leukemia.~   "
260766|NCT00136396|"~     The purpose of this study is to determine if rituximab is a safe and effective therapy for~     steroid-refractory chronic graft versus host disease (GVHD).~   "
260767|NCT00136383|"~     This double-blind placebo-controlled trial is designed to test and to compare the~     cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients~     with depressive symptoms.~   "
260877|NCT00134940|"~     The purpose of this observational protocol is to evaluate the use of everolimus in routine~     clinical practice for heart transplants.~      Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety~   "
260770|NCT00136344|"~     Cataract is the most important cause of visual impairment and decreased mobility in the~     elderly. While surgery is usually successful, it is also responsible for permanent loss of~     vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis).~     Because of this risk, surgery is typically performed on one eye at a time leaving the patient~     with a monocular cataract causing considerable visual impairment with reduction in mobility~     and quality of life. A second operation is required which often takes place up to one year~     later.~      It is not known at present whether the post-operative complication of endophthalmitis can be~     prevented by perioperative use of antibiotics. This randomised study (masked and~     placebo-controlled for topical levofloxacin and unmasked for intracameral injection of~     cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either~     topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection~     of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the~     combination provides effective prophylaxis of post-operative infection (endophthalmitis)~     compared to controls in whom perioperative antibiotics are not used. The result will provide~     a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery~     in Europe as well as an accurate figure for the incidence of endophthalmitis following~     phacoemulsification cataract surgery in Europe for the first time.~   "
260771|NCT00136331|"~     The World Health Organisation has warned that an influenza pandemic is inevitable. The avian~     influenza H5N1 virus strain is the leading candidate to cause the next avian influenza~     pandemic. This study will test the safety and immunogenicity of a H5N1 pandemic influenza~     vaccine in healthy adults.~   "
260772|NCT00136318|"~     Primary end points~        -  incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of~          13 or higher during antiviral therapy (up to 48 weeks, depending on genotype)~        -  effect of an antidepressive pre-treatment over two weeks and a continuously concomitant~          treatment with Escitalopram (S-citalopram) on frequency and severity of depression in~          patients with chronic hepatitis C (HCV) treated with Peg-interferon alfa-2a (PEGASYS)~          and ribavirin, measured by the Montgomery Asberg Depression Scale~      Secondary end points~        -  time to depression defined as a MADRS score of 13 or higher~        -  incidence of major depression defined by Diagnostic and Statistical Manual IV (DSM-IV)~          criteria~        -  severe depression according to MADRS scale (score 25 or higher)~        -  Health related quality of life (HRQOL) measured by the Short Form 36 (SF-36)~        -  sustained virologic response~        -  tolerability~        -  safety~        -  changes/group differences in other psychiatric depression scales (Hamilton Depression~          Rating Scale, Beck Depression Inventory)~      Other investigations:~        -  cognitive function, anxiety (word fluency test, trail making test part A and B, othe~          scales)~        -  Predictive parameters for patients especially gaining from an antidepressive therapy~          (e.g. age, gender, weight, height, alanine aminotransferase (ALAT) quotient defined as~          median ALAT values before treatment divided by the upper standard value, HCV-RNA serum~          concentration level of fibrosis in liver histology, baseline values of the different~          psychometric scales)~        -  alanine aminotransferase (ALAT), aspartate transaminase (ASAT), thyrotrophin (TSH)~        -  biomarkers (genetic parameters, cytokines,...)~   "
260773|NCT00136305|"~     The purpose of this study is to evaluate and compare the relative effectiveness of two asthma~     action plans (pictorial versus written) in terms of asthma action plan knowledge, medication~     use, and family satisfaction with asthma education.~   "
260774|NCT00136292|"~     The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin~     in patients aged 2-17 years old who have a suspected or proven gram-positive infection for~     which they are receiving standard antibiotic therapy. The tolerability of a single dose of~     daptomycin in these patients will also be assessed.~   "
260775|NCT00136279|"~     The purpose of this study is to develop and evaluate the effectiveness of a parent-based~     intervention that can be implemented in conjunction with existing school-based programs~     designed to prevent or reduce sexual risk behavior or to prevent or reduce tobacco use in~     young adolescents. The parent programs are expected to have effects on adolescent behavior~     over and above the effects of the school-based programs.~   "
260776|NCT00136266|"~     Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children~     beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron~     deficiency.~   "
260777|NCT00136253|"~     American hemodialysis patients are frequently malnourished. This contributes to dialysis~     patient mortality rates that are the highest in the industrialized world at 22% per year.~     Poor nutritional status probably also contributes to high health care costs (an average of~     two hospitalizations annually per patient and total Medicare expenditures of $11 billion per~     year) and diminished quality of life. The researchers' prior work identified several~     potentially modifiable nutritional barriers (e.g. poor appetite, inadequate dialysis dose,~     poor nutritional knowledge, low fluid intake, and needing help shopping and cooking) and~     pilot tested a promising approach to overcome these barriers.~      This proposed community-based randomized controlled trial extends the researchers' prior work~     by targeting specific nutritional barriers with a tailored feedback and education~     intervention. Approximately 40 dialysis facilities in northeast Ohio will be randomly~     assigned to intervention and control groups, with approximately 100 malnourished patients~     enrolled from 20 intervention facilities and 100 from 20 control facilities. Baseline~     evaluation will include measures of nutritional status, specific barriers, inpatient~     expenditures, and quality of life. On a monthly basis for 12 months, intervention patients~     and their dietitians will receive tailored feedback and education on overcoming~     patient-specific barriers. They will then meet monthly to jointly formulate a care plan~     addressing these barriers. Control patients will continue to get usual care. Major analyses~     will compare changes in nutritional parameters in intervention vs. control patients with~     adjustment for nesting of patients within facilities.~      The proposed project will test a novel intervention that targets patients and providers as~     they together make nutrition-related decisions. Overcoming specific barriers may lead not~     only to improved nutritional status but also to better patient survival, decreased health~     care costs, and increased quality of life.~   "
260778|NCT00136240|"~     This study will determine the efficacy of a computerized telephone system called~     Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in~     people with depression.~   "
260802|NCT00135915|"~     Although there is no evidence that individuals with type 1 diabetes have a different approach~     to alcohol compared to the background population, nevertheless, its use does have~     implications for patients mainly because of the risk of hypoglycaemia unawareness. However,~     binge drinking has been implicated as a factor in the development of ketoacidosis and is~     probably under-recognised. The aim of this study is to examine the effect of binge drinking~     on glucose, insulin, counter-regulatory hormones and other metabolites in patients with type~     1 diabetes. It is hoped that data from this project will be used to develop a larger study~     comparing different treatment regimens for patients using alcohol to reduce the risks of~     hyperglycaemia as well as hypoglycaemia.~   "
260779|NCT00136227|"~     During this first year, the researchers have worked toward identifying factors influencing~     initiation of colorectal cancer screening among Hispanic men and women aged 50 and older and~     developing an intervention plan using Intervention Mapping, a framework for systematic health~     promotion program planning, implementation, and evaluation. The researchers are also~     currently in the preliminary stages of developing two promotora (lay health worker)-delivered~     interventions: a small media intervention (video, flip chart, pamphlets) and a tailored~     interactive multimedia intervention, prior to the actual collection of data. Thus, although~     733 subjects have been approved by the Committee for the Protection of Human Subjects to be~     enrolled in this study in the future, no subjects have been enrolled at this time.~     Consequently, there have been no adverse events, and since the risks associated with~     participating in this study are negligible, the researchers do not anticipate any adverse~     events in the future. No modifications have been made to the research since the last review,~     other than that the researchers are currently reassessing the need to conduct preliminary~     qualitative research as proposed in the original protocol.~   "
260780|NCT00136214|"~     The hypothesis of this study is that pegylated interferon would cause cognitive deficits and~     mood changes in hepatitis C (HCV) positive subjects.~   "
260781|NCT00136201|"~     The primary objective of this study is to compare the safety and efficacy of an experimental~     antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated~     intra-abdominal infections. <br />~   "
260782|NCT00136188|"~     Experimental data suggest that oxidative stress and endothelial dysfunction are key players~     in the pathogenesis of diabetic nephropathy. In the last few years the investigators were~     able to establish a method to assess endothelial function of the renal vasculature in humans~     and started to systematically study a variety of cardiovascular disorders known to be~     associated with endothelial dysfunction in other vascular beds, including hypertension,~     hypercholesterolemia and type-2 diabetes. In patients with type-2 diabetes the investigators~     could demonstrate that despite unaltered basal and stimulated NO-activity, the renal response~     to the antioxidant vitamin C was more pronounced compared to control subjects. These data~     suggest that oxidative stress is increased in the renal vasculature of diabetic patients.~     Furthermore, NO-activity in diabetic patients appears to be upregulated to compensate for the~     increase in oxidative stress. This hypothesis is supported by the demonstration of increased~     endothelial nitric oxide synthase (eNOS) expression in kidney biopsies of diabetic patients.~      The major focus of the investigators' current research activities is to assess the role of~     endothelial dysfunction in the very early stages of diabetic nephropathy. To this end,~     patients with increased fasting glucose or metabolic syndrome will be studied in comparison~     with an age-matched control group. Endothelial function and the role of oxidative stress will~     be assessed in the renal vasculature in all groups. In parallel, the investigators will study~     endothelial function in the forearm by venous occlusion plethysmography and in the retinal~     vasculature by scanning laser doppler flowmetry to dissect regional differences in the~     regulation of endothelial function. Further aspects include the role of microalbuminuria,~     glomerular hyperfiltration, and endogenous inhibitors of NO synthase such as~     NG,NG-Dimethyl-L-Arginine (ADMA). In a therapeutic approach, the investigators will determine~     the effects of various antioxidant treatment strategies on endothelial function and their~     potential role in the prevention of diabetic nephropathy.~   "
260783|NCT00136175|"~     This trial will evaluate the efficacy and safety of combination chemotherapy (paclitaxel,~     carboplatin, and gemcitabine) prior to surgery in the treatment of patients with locally~     advanced transitional cell cancer of the bladder.~   "
260784|NCT00136149|"~     This is a study to evaluate immediate implants.~   "
260785|NCT00136136|"~     This study will evaluate the registration of the bispectral index and spectral edge frequency~     in relation to the behavioural state.~   "
260786|NCT00136123|"~     This study will evaluate the placement of implants with minimal invasive techniques.~     Immediately after the placement of the implants, functional loaded synthetic teeth will be~     placed.~   "
260787|NCT00136110|"~     The purpose of this study is to determine whether the use of sodium valproate is effective in~     slowing the disease progression in Amyotrophic Lateral Sclerosis.~   "
260788|NCT00136097|"~     This is an evaluation of the use of silver impregnated catheters in burn patients to reduce~     catheter colonisation compared to the standard central venous catheter without antiseptic~     activity.~   "
260789|NCT00136084|"~     The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy~     regimens using different dosages of cytarabine to eliminate all detectable leukemia.~   "
260790|NCT00136071|"~     Urinary incontinence (involuntary leakage of urine) is an extremely common, distressing and~     socially disabling condition. It is known to affect up to 14 % of the adult female population~     in the United Kingdom. Sufferers tend to become social recluses, not wanting to socialise for~     fear of embarrassment and ridicule. It typically takes up to 5 years from the onset of~     symptoms for a patient to admit their problem, seek help and reach a specialist.~     Unfortunately, it is commonest in the elderly when the incidence is as high as 50% in some~     studies. Furthermore, this group of patients are the least likely to seek help, the least~     likely to receive help and up until recently the least likely to be cured of their problems.~      Things are improving however, as everyone is more prepared to talk about this awful condition~     rather than accept it as a part of growing old. Furthermore, better treatments are becoming~     available which can help the old as well as the young.~      Two years ago a new operation for urinary leakage was launched in the United Kingdom (UK).~     This is a smaller operation than those previously available and more suitable for the frail~     and elderly. We, the researchers at South Glasgow University Hospital, have been using this~     operation for 18 months with good success. Several versions however are now on the market,~     some much more expensive than the original, and perhaps not as good. We need to know which~     one is best and hence we intend to do a study to find out.~      We aim to select patients with leakage to have one or the other operation and to follow the~     patients over several years to find out which operation is best, safest, lasts longest and is~     most acceptable to patients. Only then will we know which of the versions of this procedure~     we should be offering our patients.~   "
260791|NCT00136058|"~     The objective of this study is to determine if an intervention with a fracture manager to~     arrange bone densitometry after a hip fracture is more effective in diagnosing and treating~     osteoporosis when compared to usual care. Usual care consists of no intervention to~     arrange bone mineral density (BMD) testing or therapy other than what normally occurs in the~     community. The investigators postulate that a fracture manager will be more effective in~     getting BMD done and in starting appropriate therapy.~   "
260831|NCT00135538|"~     The purpose of this study is to investigate whether noninvasive ventilation by nose mask~     during the night has additional benefits next to pulmonary rehabilitation in patients with~     severe hypercapnic COPD.~   "
260832|NCT00135525|"~     This study is designed to evaluate the efficacy and safety in Generalized Anxiety Disorder~     patients~   "
260833|NCT00135512|"~     This study was designed to evaluate the efficacy and safety in major depressive disorder~     patients.~   "
260792|NCT00136045|"~     The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is~     efficacious in subjects with idiopathic restless leg syndrome (RLS). Additional objectives~     are to investigate the safety and tolerability of rotigotine.~      The primary variables are the absolute change from Baseline in the International Restless~     Legs Severity Scale (IRLS) sum score and Clinical Global Impression-Global Improvement (CGI)~     Item 1 (severity of illness) score at the end of the Maintenance Period.~      Subjects will be randomized to receive either placebo, 2.25, 4.5 or 6.75 mg/day rotigotine in~     a 1:1:1:1 (active:placebo) fashion. Approximately 450 subjects will be enrolled in this~     trial, participating at approximately 50 sites. The maximum duration of the trial is~     approximately 8 months (3-week Titration Period, 6-month Maintenance Period, 7-day Taper~     Period, and 30-day Safety Follow-Up Period). Subjects who complete the 6-month Maintenance~     Period will be eligible to participate in an open-label extension trial. Subjects who do not~     complete the 6-month Maintenance Period or who choose not to participate in the open-label~     extension trial will complete a 3-day Safety Follow-Up Period. Two different patch sizes will~     be used (5 and 10 cm2). Active patches will contain either 2.25mg (5cm2) or 4.5mg (10cm2) of~     rotigotine.~   "
260793|NCT00136032|"~     The purpose of the study is to evaluate the effects of growth hormone replacement on women~     with growth hormone deficiency. Growth hormone deficiency means the body no longer produces~     growth hormone due to a tumor or some kind of disease of the brain in an area called the~     pituitary/hypothalamic region. This is the area of the brain where growth hormone is normally~     produced. We, the researchers at Massachusetts General Hospital, will establish the effects~     of growth hormone replacement on cardiovascular parameters (laboratory tests, the flexibility~     of the arteries, changes in heart rate) in women with growth hormone deficiency. Our goal is~     to see if this therapy:~        -  has effects on women's cardiovascular risk markers (special blood tests which indicate~          how healthy the heart and arteries are)~        -  has effects on women's types and levels of various substances circulating in their blood~        -  in women affects the stiffness of their arteries and heart rate variability in parallel~          with changes in cardiovascular risk markers~        -  has different effects depending on whether women are pre or post menopausal.~      Participation in this study is expected to last approximately 12 months.~   "
260794|NCT00136019|"~     Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with~     partial seizures and are taking up to 3 medications for this medical condition will take part~     in a research study at approximately 85 different locations in the United States.~      The purpose of the study is to evaluate the effectiveness, safety and tolerability of~     consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for about~     five months.~      Each patient who qualifies and chooses to participate in the study will receive placebo~     (inactive drug) or gradually increasing doses of lacosamide up to the target dose of~     400mg/day or 600mg/day. The target dose or placebo will be maintained for 12 weeks.~      The study clinic visits will include a medical history and physical exam, electrocardiogram~     (ECG), blood and urine sample collection, and completion of a seizure diary.~      Patients who complete the study may enroll in an extension trial and receive active study~     drug.~   "
260795|NCT00136006|"~     This is a study of the lung health of the population of Vancouver and the extent of, and the~     risk factors for, chronic obstructive lung disease.~   "
260796|NCT00135993|"~     Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4~     cardinal clinical features according to the International Restless Legs Syndrome Study Group~     (IRLSSG) are allowed to enroll in this trial.~      The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is~     efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to~     investigate the safety and tolerability of rotigotine.~      Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day~     rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be~     enrolled in this trial, participating at approximately 60 sites. The maximum duration of the~     trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month~     Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).~   "
260797|NCT00135980|"~     The purpose of this study is to compose, implement and evaluate a programme to improve the~     quality of integrated care for patients with cancer.~      Literature will be searched for components of integrated care programmes. On the basis of~     evidence based multi-disciplinary guidelines and literature on integrated care programmes, a~     set of indicators will be composed. This set will be measured in 6 hospitals on patients with~     non-small-cell-lung cancer. In two hospitals, an integrated care programme will be~     implemented and effects on processes and outcomes of care will be measured.~   "
260798|NCT00135967|"~     Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for~     end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a~     treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side~     effects.~      In this pilot study patients with membranous nephropathy and renal failure will be treated~     with mycophenolate mofetil and prednisone. The outcome will be compared with historical~     controls treated with a similar regimen containing cyclophosphamide.~   "
260799|NCT00135954|"~     Patients with idiopathic membranous nephropathy at risk for renal failure can be identified~     in an early stage by measuring urinary low molecular weight proteins and urinary~     immunoglobulin G (IgG). This study evaluates the possible benefit of early start of~     immunosuppressive therapy in these high-risk patients.~   "
260800|NCT00135941|"~     The purpose of this study is to test for superiority in improvements from baseline in patient~     reported outcomes in subjects with type 1 or type 2 diabetes when treated with insulin~     glargine plus rapid acting insulin glulisine MDI versus treatment with premix insulin.~   "
260801|NCT00135928|"~     The purpose of this trial is to investigate the effect of treatment with granulocyte-colony~     stimulating factor (G-CSF) bone marrow stimulation on circulating stem cells' ability to~     develop new blood vessels in the myocardium after an acute myocardial infarction.~   "
260834|NCT00135499|"~     The primary objective of this study is to evaluate the efficacy of doxorubicin,~     cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison~     to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients~     aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as~     measured by the event-free survival. The goal is to obtain a 10% increase of event-free~     survival at 3 years.~   "
260803|NCT00135902|"~     A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate~     (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However,~     the group who received 17P in this trial still had a high rate of preterm birth. Several~     reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty~     acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3~     supplement to 17P therapy has the potential for further reducing the risk of preterm birth in~     women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3~     fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is:~     Among women at high risk for preterm birth receiving weekly injections of 17P, the addition~     of Omega-3 nutritional supplement will further reduce the rate of preterm birth.~   "
260804|NCT00135889|"~     The purpose of this study is to determine if putting local anesthetic—or numbing~     medication—through a tiny tube next to the nerves that go to the knee will improve pain~     control during physical therapy, and ultimately improve the results of surgery. It will also~     determine if patients having knee replacement surgery may receive the same or better pain~     control at home compared with staying in the hospital, and if this improves their experience~     following surgery.~   "
260805|NCT00135876|"~     In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH~     (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period,~     for the prevention of VTE.~   "
260806|NCT00135863|"~     Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R)~     (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the~     morning dialysis bag. Active medication, as well as placebo, was added for three months~     separated by a one month washout period. At the beginning and end of each treatment period~     peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed.~     We, the researchers at Ribe County Hospital, set out to examine inflammation (local and~     systemic), nutrition and ultrafiltration.~   "
260807|NCT00135850|"~     The aim of this study was to evaluate the mobilization of non-haematopoietic mesenchymal and~     haematopoietic stem cells from the bone marrow with granulocyte colony stimulating factor~     (G-CSF) treatment alone and in combination with vascular endothelial growth factor (VEGF)~     gene therapy in patients with severe chronic occlusive coronary artery disease.~   "
260808|NCT00135837|"~     Age related macular degeneration is the leading cause of blindness for people over 50 in the~     western world. Blood vessels which start to grow form a lesion in the back of the eye.~     Verteporfin may stabilize the disease, by closing the blood vessels. This study will assess~     the efficacy and safety of verteporfin in patients with occult only lesions.~   "
260809|NCT00135824|"~     Instillation of artificial tears is standard treatment in dry eye syndrome and in patients~     experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone)~     is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and~     local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to~     placebo eye drops.~   "
260810|NCT00135811|"~     The FSGS Clinical Trial is a multi-center, prospective, controlled, open label randomized~     trial designed to determine if treatment with mycophenolate mofetil (MMF) in conjunction with~     pulse steroids is superior to treatment with Cyclosporine-A (CSA) in inducing remission from~     proteinuria over 12 months.~   "
260811|NCT00135798|"~     The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon~     plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected~     recipients and reduce the risk of recurrent HCV and allograft hepatitis following liver~     transplant.~   "
260812|NCT00135785|"~     Methamphetamine is an addictive stimulant drug that strongly activates certain parts of the~     brain. The purpose of this study is to determine the effectiveness of bupropion in~     combination with behavioral therapy for the treatment of methamphetamine addiction.~   "
260813|NCT00135772|"~     Nicotine dependence is very common among individuals with schizophrenia and schizoaffective~     disorder. Cotinine is a chemical that is made by the body from nicotine. Measuring levels of~     nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a~     person's body. The purpose of this study is to measure nicotine and cotinine levels in~     smokers with schizophrenia or schizoaffective disorder to determine if such individuals~     absorb more nicotine per cigarette than smokers without schizophrenia-related disorders.~   "
260814|NCT00135759|"~     There is a continuing search for more effective opiate detoxification treatments. This~     study's purpose is to investigate the effects of adding very low doses of naltrexone to a~     methadone tapering treatment in opioid dependent individuals.~   "
260815|NCT00135746|"~     Treatment studies have demonstrated that current smoking cessation techniques are less~     effective for women. The purpose of this study is to determine the role that gender plays on~     the effectiveness of nicotine replacement therapy. This may lead to improved cessation~     interventions for all smokers, particularly women.~   "
260816|NCT00135733|"~     The purpose of this study is to find out how safe and effective an investigational drug~     called alefacept (amevive) is for the treatment of moderate to severe erosive mucosal lichen~     planus.~      Lichen planus is a skin disease that can last a long time and cause significant pain,~     itching, and scarring. It can affect the mucous membranes (area inside the mouth and vagina)~     and these areas can become erosive (sores can develop). Currently there is no known cure for~     this disease.~      An investigational drug is one that has not been approved by the United States (US) Food and~     Drug Administration (FDA) to treat a particular condition or disease. Alefacept has been~     approved to treat psoriasis (a scaly skin rash). A number of reports suggest that lichen~     planus develops for some of the same reasons as psoriasis, but alefacept is not yet approved~     for the treatment of psoriasis.~   "
260817|NCT00135720|"~     The purpose of the study is to find out about the effectiveness and the safety of an~     investigational drug called etanercept (Enbrel) to treat pemphigus vulgaris. Pemphigus~     vulgaris is a potentially life threatening blistering condition that currently has no cure.~      An investigational drug is one that has not been approved by the United States (US) Food and~     Drug Administration (FDA) to treat a particular condition or disease. Etanercept has been~     approved by the FDA to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and~     psoriasis, but not pemphigus vulgaris.~   "
260818|NCT00135707|"~     Preeclampsia is one of the most common complications of pregnancy and is characterized by~     high blood pressure and protein in the urine. This can cause problems in the second half of~     pregnancy for both the mother and fetus. This study of preeclampsia consists of two parts: 1)~     a randomized, placebo controlled, multicenter clinical trial of 10,000 low-risk nulliparous~     women between 9 and 16 weeks gestation and 2) an observational, cohort study of 4,000~     patients between 9 and 12 weeks gestation who are also enrolled in the trial.~      Subjects in both parts will receive either 1000 mg of vitamin C and 400 IU of vitamin E or~     matching placebo daily. The purpose of the randomized, clinical trial is to find out if high~     doses of vitamin C and E will reduce the risk of preeclampsia and other problems associated~     with the disease. The study will also evaluate the safety of antioxidant therapy for mother~     and infant. Patients will be seen monthly to receive their supply of study drug, to have~     weight and blood pressure recorded, to have urine protein measured, and to assess any side~     effects. At two visits, blood and urine will be collected.~      The observational, cohort study will prospectively measure potential biochemical and~     biophysical markers that might predict preeclampsia. These patients will have additional~     procedures including uterine artery Doppler and blood drawn for a complete blood count (CBC).~   "
260819|NCT00135694|"~     In order to prevent organ rejection, patients receiving liver transplants currently require~     life-long treatment with immune system-suppressing medications to prevent the rejection of~     the transplanted liver. However, these medications can cause long-term side effects, such as~     infection, kidney problems, diabetes, and cancer. In patients infected with hepatitis C virus~     (HCV), these medications may increase the risk of HCV infection in the transplanted liver.~     The purpose of this study is to determine whether a slow withdrawal of immune~     system-suppressing medications is safe in two groups of subjects: those who receive a liver~     transplant due to HCV, and those who receive a liver transplant due to non-immune, non-viral~     causes of liver failure. The study will also look at whether slow withdrawal will help reduce~     the long-term side effects of immune system-suppressing medications and decrease the chance~     for HCV infection of the new liver in transplant patients with HCV.~   "
260820|NCT00135681|"~     To immunize both normal and asthmatic subjects with a neoantigen, keyhole limpet hemocyanin~     (KLH) and observe the type of antibody and T cell response that develops.~   "
260821|NCT00135668|"~     Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet~     there are no controlled studies in children. The purpose of this study is to determine the~     efficacy and safety of sodium nitroprusside in children who will be having surgery, and who~     require blood pressure lowering in order to decrease the amount of blood loss during their~     surgery.~   "
260822|NCT00135655|"~     The purpose of this study is to investigate the safety and tolerability of three dose~     strengths of the study drug in subjects with post cataract extraction macular edema.~   "
260823|NCT00135642|"~     The purpose of this study was to assess the effects of grass pollen immunotherapy on~     symptoms, bronchial hyperresponsiveness and quality of life in seasonal rhinitis and asthma.~     Hay fever symptoms and medication use, health-related quality of life, and measurements of~     non-specific bronchial responsiveness were recorded during the study period.~   "
260824|NCT00135629|"~     The purpose of this study is to determine at which point in the dosing regime grass pollen~     immunotherapy causes a significant reduction in the late skin response to allergen challenge.~     A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing~     phase, followed by monthly maintenance injections of 100,000 SQ units. Symptom scores and~     need of rescue medication were recorded by patients during the study period. The size of~     early and late cutaneous response to allergen challenge was recorded and measured by a~     physician.~   "
260825|NCT00135616|"~     The purpose of this study is to compare efficacy and morbidity following the placement of two~     types of suburethral slings in women presenting with stress urinary incontinence: TVT and~     TVT-O.~   "
260826|NCT00135603|"~     The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective~     as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty~     patients will be included in a prospective multicentric randomized trial. The primary~     endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other~     criteria will be studied including duration of hospital stay and absence from work during a~     follow up period of one year, parietal and abdominal complications and recurrent appendicitis~     after antibiotic therapy.~   "
260827|NCT00135590|"~     The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient~     in improving muscle mass and immune functions than was a protein spread-feeding pattern,~     after 45 days, in elderly malnourished patients.~   "
260828|NCT00135577|"~     Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of~     multiple dosage regimens of an investigational drug for the treatment of constipation due to~     prescription pain medication in participants with cancer pain.~      Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access~     to blinded investigational product to participants who have completed the original study. The~     purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to~     placebo in subjects who completed Study SB-767905/008 and elected to participate in this~     extension study.~   "
260829|NCT00135564|"~     The purpose of this booster vaccination study is to evaluate the persistence and immune~     memory induced by a three-dose primary vaccination course with GSK Biologicals' MenC-TT~     (Neisseria meningitidis group C polysaccharide-tetanus toxoid) and GSK Biologicals'~     Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) or Meningitec™ vaccines in healthy~     toddlers aged 12-15 months by giving them a 1/5th dose of Mencevax™ ACWY.~   "
260830|NCT00135551|"~     A number of major clinical trials have demonstrated the clinical benefits of lowering blood~     pressure and have indicated that a majority of patients with hypertension will require more~     than one drug to achieve optimal blood pressure control.~      There is little data showing which antihypertensive combination best protects patients from~     cardiovascular events and which best achieves the target blood pressure with the fewest~     adverse events.~      The COPE trial is planned to investigate, in patients with hypertension, which combination of~     the antihypertensive drugs, angiotensin receptor blockers, β-blockers or thiazide diuretics~     in addition to a long-acting calcium antagonist, benidipine hydrochloride, is superior to~     achieve the targeted blood pressure and prevent cardiovascular events with the fewest adverse~     drug effects.~   "
260835|NCT00135486|"~     The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and~     reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C~     polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK~     Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different~     formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant~     vaccines were given to all children to complete the vaccination agenda.~   "
260836|NCT00135473|"~     The purpose of this trial is to determine the influence of colloid versus crystalloid volume~     resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of~     patients with severe sepsis and septic shock.~   "
260837|NCT00135460|"~     Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV~     infected individuals. However an increasing number of HIV-patients have developed metabolic~     and morphological alterations including peripheral lipoatrophy.~      There is limited knowledge about lipodystrophic adverse events in nucleoside reverse~     transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues~     are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing~     regimen will have little risk of peripheral lipoatrophy.~      The researchers plan to perform a randomized study recruiting 100 antiretroviral naive~     patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a~     protease-inhibitor sparing regimen.~      The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray~     absortiometry (DEXA)-scanning.~   "
260838|NCT00135447|"~     The purpose of this study is to find out the frequency of the I50L substitution among~     patients experiencing treatment failure on an atazanavir-containing regimen.~   "
260839|NCT00135434|"~     This study examined the effects of two commonly prescribed HIV drugs on the way the body~     metabolizes glucose, insulin and fat.~   "
260840|NCT00135421|"~     The purpose of this clinical research study is to learn whether BMS-562086 is both safe and~     effective in treating outpatients with major depressive disorder.~   "
260841|NCT00135408|"~     The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010~     (BMS-734016) administered with or without Prophylactic Oral Budesonide.~   "
260842|NCT00135395|"~     The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum~     lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1~     infected subjects who have experienced their first virologic failure while receiving a~     NNRTI-containing HAART regimen.~   "
260843|NCT00135382|"~     The purpose of this study is to demonstrate that virologically controlled HIV-infected~     individuals can successfully switch from a protease inhibitor (PI)-based regimen to an~     efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion~     of subjects who continue to have plasma HIV-1 levels < 50 copies/mL. In addition, a~     simplified once-daily regimen will improve adherence and quality of life.~   "
260844|NCT00135369|"~     The purpose of this study is to demonstrate that virologically controlled HIV-infected~     individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more~     frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as~     evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50~     copies/mL after switching to a QD regimen.~   "
260845|NCT00135356|"~     The purpose of this clinical research study is to learn if human immunodeficiency virus~     (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral~     treatment (HAART) regimen have better changes in fat distribution after switching to~     atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART~     regimen.~   "
260846|NCT00135343|"~     The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside~     sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of~     atazanavir.~   "
260847|NCT00135330|"~     This protocol is designed to evaluate the metabolic effects of adding exenatide,~     rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate~     glycemic control.~   "
260848|NCT00135317|"~     The study is designed to assess if the addition of intravenous (IV) iron to 500 mcg every 3~     week (Q3W) darbepoetin alfa treatment enhances response as compared to the standard practice~     (oral iron or no iron administration).~   "
260849|NCT00135304|"~     The purpose of this study is to compare the proportion of chronic kidney disease (CKD)~     subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of~     vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease~     Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment~     targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P)~     product.~   "
260850|NCT00135291|"~     The purpose of this study is to determine if leukoreduced blood transfusions reduce the risk~     of infection following trauma. Specifically, the investigators intend to evaluate whether~     there are clinically relevant differences in the rates of infection and in the severity of~     multiple organ failure in critically injured trauma patients receiving leukoreduced blood~     products compared to those receiving standard allogeneic blood products.~   "
260851|NCT00135278|"~     The overall purpose of this pilot study is to evaluate CSF drainage as a potential~     neuroprotective strategy after acute spinal cord injury (SCI).~   "
260874|NCT00134979|"~     This study is not being conducted in the United States.~      This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day~     (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease~     (COPD). This study is also designed to compare the efficacy and safety of therapy with~     formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.)~     compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and~     efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).~   "
260875|NCT00134966|"~     The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone~     in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy~     in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit~     than immediate release carbidopa/levodopa administered at the same levodopa dosage level of~     100 mg three times a day (t.i.d.).~   "
260852|NCT00135265|"~     This is a pilot study addressing office systems and clinician behavior change surrounding~     smoking cessation interventions for teens. The investigators' long-term goal is to improve~     the quality of clinical preventive services in practice-based research network settings.~     Their specific aims are to:~        -  a) pilot procedures for recruitment and randomization of PROS practices; and b) field~          trial/pilot PROS practitioner cessation counseling and practices' enrollment of~          adolescent patients; and~        -  assess the feasibility of pediatric clinician referral of adolescent patients to~          internet-based adjuncts for smoking cessation.~      The investigators will evaluate a pilot round of recruitment and randomization, and smoking~     cessation training and delivery in 10 PROS practice sites; and assess the acceptability of~     study procedures and on-line internet counseling adjunct referral feasibility within PROS~     practice sites. Up to 1000 adolescents presenting for well visits will complete a short~     baseline survey prior to their well-visit. A sample of them will be surveyed by phone at 4-6~     weeks to provide preliminary estimates of cessation counseling effectiveness for future~     studies. The investigators will field test measures, describe the patterns of smoking among~     youth, and explore how much receiving interventions affects motivation, quitting,~     abstinence/relapse attitudes, attitudes towards internet-based outreach strategies, and~     behaviors for 100 smokers.~      **we have completed recruitment of providers; we are recruiting teens ONLY at this point**~   "
260853|NCT00135252|"~     Infants of < 1500 grams of birth weight who require a > 1 week mechanical ventilation~     (breathing machine) or CPAP [continuous positive airway pressure] (oxygen at a high flow~     through the nose) may have prolonged oxygen requirements. The nasal cannula (oxygen through~     the nose at a low flow) is the most commonly used method of oxygen administration, despite a~     lack of data regarding its safety and efficacy. Low birth weight infants are vulnerable to~     obstruction from secretions and blood, as well as the presence of the nasal cannula.~     Partially obstructed nostrils greatly increase the work of breathing. Additional potential~     adverse effects include an increased need for suctioning, increased risk for systemic~     infection, and inadvertent positive end expiratory pressure (CPAP). No study has been~     conducted to evaluate the efficacy of the nasal cannula compared to an oxygen hood (plastic~     hood that is placed over the infant's head to provide oxygen) on gas exchange or infection.~      Among infants who require supplemental oxygen (by either a nasal cannula or an oxygen hood)~     for clinical indications, objectives the investigators hope to accomplish in a randomized~     blinded (investigator) trial:~      Aim 1: To determine the short-term effect of different flows of oxygen by the nasal cannula~     on transcutaneous PCO2 (PTCO2).~      Aim 2: To determine, once optimal flow is established in Aim 1, the effect of prolonged (one~     week) use of a nasal cannula compared to an oxygen hood on PTCO2.~   "
260854|NCT00135239|"~     The most common work-related injury in British Columbia every year is a lower back injury.~     The many different treatment options that are available to workers with a back injury have~     often led to confusion and frustration. New back pain research has shown which combinations~     of treatments are most helpful, but has also shown that many injured workers in British~     Columbia do not have these treatments made readily available to them. This research study is~     designed to accurately determine whether or not providing patients suffering from acute back~     injuries with a combination of all of these recommended treatments, will improve their~     function, quality of life and return to work.~   "
260855|NCT00135226|"~     The purpose of this study is to determine whether 100mg daily aspirin versus placebo and/or~     supplementation with 1 gram daily omega-3 fatty acids or placebo prevents serious vascular~     events (i.e. non-fatal heart attack, non-fatal stroke or transient ischaemic attack, or~     death from vascular causes) in patients with diabetes who are not known to have occlusive~     arterial disease and to assess the effects on serious bleeding or other adverse events.~   "
260856|NCT00135213|"~     The investigators' long-term goal is to improve the quality of services targeting the~     prevention of secondhand smoke (SHS). Their specific aims are to:~        -  refine components of office systems and counseling interventions for parental tobacco~          control in pediatric outpatient settings; and~        -  pilot test the feasibility and efficacy of a parental tobacco control randomized~          controlled trial in pediatric office settings using 5 intervention and 5 comparison~          pediatric practice sites.~      The investigators hypothesize that:~        -  clinicians in intervention practices (compared to those in control practices) will more~          often implement successful office systems, screen for parental smoking, advise parents~          to quit and to prohibit smoking and SHS exposure at home, recommend pharmacotherapy,~          provide adjuncts, and refer parents to cessation programs; and~        -  parents who smoke in intervention practices (measured by 3-month follow-up telephone~          surveys) will be more likely than those in control practices to have received cessation~          services, use pharmacotherapy, make lasting quit attempts, and institute rules to~          prohibit smoking and limit SHS exposure at home.~   "
260857|NCT00135200|"~     This study is for patients with newly diagnosed or relapsed multiple myeloma. The main~     purpose of this study is to see how their disease responds to consolidation treatment~     (treatment aimed at further decreasing cancer cells) with a radioactive antibody (protein)~     called iodine I 131 tositumomab (known by the tradename Bexxar®) and also to look at the side~     effects which occur with this type of treatment. The investigators will also be looking at~     how long disease responds to treatment, if it responds at all, and how long patients who have~     had this treatment survive.~      Bexxar is a monoclonal antibody (protein) to which radioactive iodine 131 is attached. The~     monoclonal antibody in Bexxar (tositumomab), targets a protein called CD20 found on the~     surface of a variety of B-cells, including lymphoma cells, and some myeloma cells. The~     antibody is given as an infusion and finds its way to these cells. The radioactive iodine~     attached to the antibody delivers radiation directly to these cells which works to harm or~     kill the cancer cells. Approximately 20-25% of patients with multiple myeloma have this~     protein on the surface of their tumor cells. In addition, this protein was found on the~     surface of myeloma stem cells. While myeloma stem cells represent a minority of all myeloma~     cells (less than 5%), these cells are resistant to chemotherapy and are believed to be~     responsible for a recurrence of the disease after chemotherapy. In this study, Bexxar will be~     used after patients complete a course of chemotherapy and have residual myeloma cells left in~     their body. The Investigators are hoping that the treatment with Bexxar will decrease and~     possibly eliminate residual myeloma cells resistant to chemotherapy.~   "
260858|NCT00135187|"~     Patients are being asked to take part in this research study because they have multiple~     myeloma which has relapsed after (come back), or is refractory to (unaffected by), initial~     therapy.~      For patients who have relapsed or are refractory to therapy, there is no agreed upon standard~     treatment. Treatment options include chemotherapy and, for some patients, bone marrow~     transplants. None of the available treatments are curative and investigators are continually~     looking for more effective treatments. This study involves treatment with a new combination~     of standard drugs: VELCADE, Doxil, and Dexamethasone. Preliminary results from a study using~     a combination of VELCADE with Doxil showed high response rates (disease reduction). Two other~     studies showed that an addition of Dexamethasone to VELCADE in patients not responding to~     VELCADE alone improved response rate. The proposed combination of all three drugs may improve~     efficacy and response.~      VELCADE is approved by the Food and Drug Administration (FDA) for use in multiple myeloma.~     Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients~     with some other cancers. Several published clinical trials provide evidence that Doxil is an~     active agent in multiple myeloma and it is used in treatment combinations for multiple~     myeloma in general practice. Dexamethasone is approved for use in multiple myeloma. The~     combination of all three drugs is experimental (not FDA approved).~      The goals of this study are to determine if this new combination therapy with VELCADE, Doxil~     and Dexamethasone is an effective treatment, and also to determine the side effects that~     occur when this combination treatment is given.~   "
260859|NCT00135174|"~     The overall objective of the study is to quantify the true prognostic value and~     cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker~     of any type for the first time.~   "
260860|NCT00135161|"~     The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography~     (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).~   "
260861|NCT00135148|"~     Participants fill out a questionnaire on libido and their possible partner relationship.~      A blood sample is taken for sex steroid analysis.~   "
260862|NCT00135135|"~     This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in~     children with high-risk neuroblastoma followed by standard induction chemotherapy,~     intensification with autologous stem cell transplantation, and an oral maintenance phase with~     13-cis-retinoic acid and topotecan. We hypothesize that the ZD1839 (gefitinib) and irinotecan~     window will be efficacious.~   "
260863|NCT00135122|"~     The purpose of this study is to determine whether prednisolone is more effective than placebo~     in the first six days after initiation of medication withdrawal therapy for a medication~     overuse headache. Another purpose is to study whether patients followed by a neurologist 1~     year after withdrawal do better than patients followed by a general practitioner.~   "
260864|NCT00135109|"~     This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.)~     to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with~     diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to one of~     three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful~     distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average~     pain intensity of greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during~     the 7 day period prior to the start of treatment.~      To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a~     diary to record their daily pain intensity (morning and evening; and pain interference with~     sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and~     subjects' quality of life will be investigated. In addition, the safety and tolerability of~     the different doses of lacosamide will be investigated.~   "
260865|NCT00135096|"~     The purpose of this study is to compare the change in weight from baseline to study week 52~     in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal~     Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.~   "
260866|NCT00135083|"~     The purpose of this study is to show the non-inferiority of insulin glulisine administered~     with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c~     (HbA1c), from baseline to study week 24.~   "
260867|NCT00135070|"~     Hyperglycaemia has been shown to increase morbidity and mortality in patients with critical~     illness, myocardial infarction and stroke. This study aims to look at patients with~     hyperglycaemia and reduce their blood sugar levels using differing combinations of~     subcutaneous and intravenous insulin.~   "
260868|NCT00135057|"~     The purpose of this study is to compare the change in glycemic control, as measured by~     hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin~     glulisine as mealtime insulin following a variable bolus insulin regimen (based on~     carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal~     insulin in both arms of the study.~   "
260869|NCT00135044|"~     The purpose of this study is to investigate whether the inclusion of 1g of intravenous~     taurine as part of the nitrogen source of parenteral nutrition reduces parenteral nutrition~     associated cholestatic liver disease, a common side effect of parenteral nutrition.~   "
260870|NCT00135031|"~     The purpose of this study was to determine the dose-ranging efficacy and safety profile of~     encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome~     (IBS).~   "
260871|NCT00135018|"~     This study will investigate whether cyclooxygenase inhibition with celecoxib will add any~     benefit to preoperative chemotherapy alone for breast cancer patients.~   "
260872|NCT00135005|"~     This study is an open-label, multicenter, Phase I dose-escalation study of the combination of~     AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed~     to determine the Phase II dose of AMN107 and imatinib when administered together in patients~     with imatinib-resistant GIST, and to characterize the safety, tolerability and~     pharmacokinetic (PK) profile of this combination.~   "
260873|NCT00134992|"~     The objective of this trial was to confirm the tolerability of prednisolone acetate 0.5% eye~     drops by testing the hypothesis that the ocular safety and tolerability of prednisolone~     acetate 0.5% eye drops are equivalent to vehicle. Thus healthy volunteers have been selected~     and have been treated by using a crossover design.~   "
260876|NCT00134953|"~     This study is designed to investigate the efficacy and safety of rivastigmine compared with~     placebo in patients with mild cognitive impairment (MCI).~   "
260878|NCT00134927|"~     Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter~     (OTC) status in the United States. Little is known about how the public uses the OTC nicotine~     patch due to lack of monitoring. The purpose of this observational study is to describe the~     characteristics of consumers who purchase OTC nicotine patches from community pharmacies and~     to determine the factors associated with the appropriate use of nicotine patches.~   "
260879|NCT00134914|"~     Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to~     buprenorphine in order to limit the abuse potential that is commonly associated with~     buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone~     when given through different routes and at different doses.~   "
260880|NCT00134901|"~     Cocaine is one of the most widely abused drugs in the United States. Memantine is a type of~     drug called an NMDA receptor antagonist. It works by decreasing normal excitement in the~     brain. NMDA receptor antagonists have shown to reduce cocaine-induced dopamine release in~     animal models, as well as lessen conditioned cocaine cues. The purpose of this study is to~     determine the effectiveness of memantine in preventing relapse to cocaine use in cocaine~     dependent individuals. In addition, this study will determine whether memantine produces~     better results than a placebo in decreasing cocaine craving, psychological symptoms,~     functional impairment, and discontinuation of treatment in cocaine dependent individuals.~   "
260881|NCT00134888|"~     Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse~     potential. The purpose of this study is to examine the effectiveness of~     buprenorphine/naloxone that is given at less than daily intervals, in order to prevent~     withdrawal symptoms associated with stopping opioid abuse.~   "
260882|NCT00134875|"~     Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone,~     to limit abuse potential. Parenteral administration (intravenous or intramuscular injection)~     of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals.~     However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This~     study will investigate whether naloxone decreases the opioid agonist effect from injected~     buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in~     non-dependent opioid abusers.~   "
260883|NCT00134849|"~     This study is a retrospective database review of primary care appointments of patients'~     charts with new diagnoses of hypertension.~   "
260884|NCT00134836|"~     It is recognized that a significant proportion of seniors over 75 years of age are at risk of~     functional decline, and thus of institutionalization and death. The investigators at McMaster~     University Medical Centre, are conducting is a randomized controlled trial of a preventive~     primary care outreach (PPCO) service provided to high risk seniors living in the community.~     The goal of this service is to identify unrecognized problems and individuals at increased~     risk and to link individuals to care. This preventive primary care service is provided by~     nurse case managers. The investigators have recruited patients through their family~     physicians who work in primary care networks. The investigators are screening all seniors~     aged 75 and over within these practices. The sample includes seniors aged 75 and over who are~     identified to be at risk according to the Sherbrooke Postal Questionnaire. Patients are~     randomly allocated to intervention and control groups. A research assistant, who is blind to~     group allocation, will collect data from seniors at baseline, six months, and at the end of~     one year.~      Outcome measures include health-related quality of life (quality adjusted life years~     [QALYs]), health and social service utilization and costs, mortality, institutionalization,~     functional status, and perceived health status.~      Primary Hypothesis:~      The intervention compared to usual care will result in higher health-related quality of life.~      Secondary Hypotheses:~      Compared to usual care, the PPCO intervention will result in:~        -  the same or lower costs associated with service utilization;~        -  less functional decline;~        -  reduced mortality;~        -  lower rates of institutionalization; and~        -  better self-rated health.~   "
260885|NCT00134823|"~     This study includes four projects aimed to improve the quality and safety of pediatric care~     through the implementation of four clinical decision support services in the electronic~     health record (EHR). The four projects will measure the effect of each clinical decision~     support feature including: weight-based dosing; smart forms for chronic conditions; guideline~     reminders; and a results manager to track abnormal lab result follow-up.~      Hypothesis: Implementation of the clinical decision support features will decrease medication~     errors and adverse drug events, assist physicians in adhering to clinical practice guidelines~     and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab~     results, and overall improve the safety and quality of pediatric clinical practice.~   "
260886|NCT00134810|"~     The main purpose of this study is to determine which is the best dose of a drug known as~     Dysport to give when treating one's type of upper back pain. The study will also examine the~     side effects of this treatment and its overall effect on one's disorder.~   "
260887|NCT00134797|"~     The addition of an estimate value of glomerular filtration rate (GFR) per Modification of~     Diet in Renal Disease [MDRD] (LEVEY) equation is being included and reported on all routine~     chemistry panels in the experimental group. The control group is only having serum~     creatinine, the current standard of care, reported on routine chemistry panels.~   "
260888|NCT00134784|"~     The purpose of this project is to assess the change in dopamine transporter density in~     Parkinson's disease subjects during a sixty month period including a nine month treatment~     trial of levodopa. Dopamine transporter will be assessed using [123I]ß-CIT SPECT (single~     photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of~     clinical disease state.~   "
260889|NCT00134771|"~     The purpose of this study was to determine whether giving a nutrient enriched formula to~     infants born small-for-gestational age benefits blood pressure, growth and body composition~     by six months of age.~   "
260890|NCT00134758|"~     Malignant transformation of adenomas of the duodenum is now the leading cause of death in~     familial adenomatous polyposis (FAP) patients who had a restorative proctocolectomy.~     Ursodeoxycholic acid (UDCA) modifies the biliary acid profile and could reduce the severity~     of duodenal adenomas and prevent such transformation.~   "
260938|NCT00134134|"~     The purpose of this study is to determine the effectiveness and safety of efalizumab in~     treating hydradenitis suppurativa, and to evaluate the duration of the benefit seen in people~     who respond to treatment with efalizumab, after the medication is stopped.~   "
260891|NCT00134745|"~     The purpose of this study is to examine whether a larger dosage of estrogen than the one used~     today will secure the development of a normal sized uterus and increase the strength of the~     bones in girls and young women with Turner syndrome.~      The purpose is also to evaluate whether aortic dilatation is present in this group of~     patients, and if the estrogen dosage will influence the emotional well-being and self-esteem~     of the patients.~   "
260892|NCT00134732|"~     Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the~     hospitalization of infants and young children in developed and developing countries and can~     be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000~     annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against~     human rotavirus gastroenteritis. This study will provide data for Korean regulatory~     authorities about the immunogenicity and safety of this vaccine in Korean children aged 2~     months at the time of the first dose.~   "
260893|NCT00134719|"~     This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to~     control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4,~     6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and~     rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed~     with administration of the booster dose. The Protocol Posting has been updated in order to~     comply with the FDA Amendment Act, September 2007.~   "
260894|NCT00134706|"~     The purpose of this study is to look at the effects (good and bad) of the combination of~     docetaxel and carboplatin for patients who have progressive prostate cancer after~     chemotherapy with drugs such as docetaxel. The investigators are also studying whether the~     measurement of two proteins in the blood may predict who will respond to the combination of~     docetaxel and carboplatin.~   "
260895|NCT00134693|"~     This study is designed to compare a range of doses of SB-681323 with prednisolone, which has~     known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects~     on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on~     the most effective dose of SB-681323 to use in future.~   "
260896|NCT00134680|"~     The purpose of the study is to investigate the effects (good and bad) that the combination of~     the drugs letrozole (also called Femara™) and trastuzumab (also called Herceptin®) has on~     breast cancer. The United States (US) Food and Drug Administration has approved both~     letrozole and Herceptin for the treatment of advanced breast cancer. Doctors hope that the~     combination will work better than either drug alone.~   "
260897|NCT00134667|"~     The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination~     with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of~     fluid within the eye and thereby stabilizing or improving vision when compared to Macugen~     alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be~     eligible for PDT.~   "
260898|NCT00134654|"~     The purpose of this study is to see if Premarin is useful against androgen-independent~     prostate cancer and to help understand how drugs such as Premarin may work.~   "
260899|NCT00134641|"~     The purpose of this study is to determine if the combination of gemcitabine and vinorelbine~     is effective in treating patients with advanced soft tissue sarcoma.~   "
260900|NCT00134628|"~     The principle objective of this research is to more precisely determine the degree of benefit~     that hyperbaric oxygen therapy affords in the treatment of late radiation tissue injury.~      The study has eight* components. Seven involve the evaluation of established radionecrosis at~     varying anatomic sites (mandible, larynx, skin, bladder, rectum, colon, and gyn). The eighth~     will investigate the potential of hyperbaric oxygen (HBO) therapy to prophylax against late~     radiation tissue injury.~      *(One of the arms, HORTIS IV - Proctitis has been closed to further patient recruitment. This~     decision was based on an interim statistical analysis which generated sufficient evidence to~     support closing down this arm of HORTIS.)~   "
260901|NCT00134615|"~     The purpose of this pilot project is to test the effectiveness of three 20 minute health~     education modules on patient empowerment, patient activation and retention in care.~   "
260902|NCT00134602|"~     The purpose of the study is to develop and evaluate an intervention to promote adherence to~     HIV medications among children 5-12 years of age. It compares changes in antiretroviral (ARV)~     adherence between the EIG (enhanced intervention group) and an MIG (minimal intervention~     group) from baseline to 4 months post-intervention.~      Secondary outcomes include examining whether improvement in adherence to a medication regimen~     is associated with improved health outcomes (i.e., viral load, CD4 counts, etc.); identifying~     and evaluating predictors and/or mediators of adherence; studying the feasibility of~     electronic recording in measuring adherence in an HIV-infected pediatric population; and~     evaluating the relationship between the amount of intervention received (i.e., number of~     hours/number of sessions) and changes in adherence.~   "
260903|NCT00134589|"~     The purpose of this study is to determine the effectiveness of a two-component intervention,~     that combines academic detailing at the medical practice level and distribution of decision~     aids at the patient level, on adherence to colorectal cancer screening guidelines.~   "
260904|NCT00134576|"~     The purpose of this study is to design, refine, and test for the effectiveness of a~     computer-based telephone system (Telephone-Linked Communications for Detection of Mental~     Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health~     distress; educate them about seeking treatment; and follow up with them over a 6 month~     period.~   "
260905|NCT00134563|"~     The primary objective was to determine the effect of teriflunomide on the frequency of~     relapses in patients with relapsing multiple sclerosis (MS).~      Secondary objectives were:~        -  to evaluate the effect of teriflunomide on the accumulation of disability as measured by~          Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic~          Resonance Imaging [MRI] and patient-reported fatigue;~        -  to evaluate the safety and tolerability of teriflunomide.~   "
260939|NCT00134108|"~     The purpose of this study is to conduct a formal controlled evaluation of the potential~     benefits of CBT for insomnia in cancer patients.~   "
260999|NCT00133328|"~     The JIKEI HEART Study has been designed to investigate whether concomitant treatment with~     valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment,~     will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.~   "
260906|NCT00134550|"~     Lower limb complications are a substantial matter in the diabetic population and studies show~     that the annual incidence of foot ulcers ranges from 1.0-4.1% while the cumulative lifetime~     incidence is approximately 15%. Foot ulcers may become complicated by infection or gangrene,~     and ultimately result in amputation. In addition, foot ulcers have a significant impact on~     quality of life (QoL). The treatment of diabetic foot ulcers has not made substantial~     progress in recent years with regards to improved healing although there have been several~     actions taken to update the process. The current practice consists of wound debridement,~     treatment of underlying infections and pressure relief. This trial investigates the~     adjunctive effects of high (80 mg) or low (10 mg) dose atorvastatin to conventional treatment~     on the healing of diabetic foot ulcers.~   "
260907|NCT00134537|"~     The purpose of this study is to compare improvement in low back pain with Wallis~     (interspinous process implant) to exercise and injections.~   "
260908|NCT00134524|"~     This study is intended to demonstrate that exposure to a high intensity, DC electromagnetic~     field, as supplied by the investigational device known as the Molecular Magnetic Energizer~     (MME), will create a clinically meaningful improvement in pain and nerve dysfunction in the~     feet of patients with diabetic peripheral neuropathy (DPN).~   "
260909|NCT00134511|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients~     with genetically known disorder of extremely high cholesterol~   "
260910|NCT00134498|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in~     subjects with Fredrickson Type IV Hypertriglyceridemia.~   "
260911|NCT00134485|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin~     alone in patients with heterozygous familial hypercholesterolemia~   "
260912|NCT00134472|"~     The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma~     patients, improves neurological outcome.~   "
260913|NCT00134459|"~     The purpose of the study is to investigate whether eight weeks of treatment with flexible~     doses of bifeprunox is superior to treatment with placebo in depressed patients with bipolar~     disorder.~   "
260914|NCT00134446|"~     The purpose of this study is to determine if transcranial magnetic stimulation at 1 HZ to the~     right frontal cortex will decrease the symptoms of post-traumatic stress disorder (PTSD).~   "
260915|NCT00134433|"~     Coronary artery disease is the single most important killer of Canadians. Despite major~     advances in therapy, there is still a significant proportion of patients identified with the~     disease who die of it because current treatment approaches cannot effectively palliate their~     condition. A new treatment modality called therapeutic angiogenesis has appeared on the~     clinical research scene during the last five years; this approach recreates the natural~     processes of new blood vessel formation that is observed during growth and development in~     every human being. It is an extremely potent and promising modality, but so far the results~     of clinical trials in patients have been equivocal.~      One reason for the limited efficacy observed thus far with therapeutic angiogenesis may rest~     in that factors produced by the lining of the coronary arteries themselves are essential for~     angiogenic substances to take effect in the heart muscle of patients with severe coronary~     artery disease. These same patients, however, virtually all have, as a result of their~     disease, marked dysfunction of their coronaries and therefore fail to produce these factors~     in adequate quantities. This hypothesis has been verified with extensive animal data by the~     investigators of this research, where a swine model of coronary disease was shown to severely~     inhibit the action of angiogenic growth factors. If one wants angiogenesis to work, a means~     of improving the function of the coronary lining of patients with severe ischemic heart~     disease must be identified and its effects evaluated in order to allow for angiogenic~     substances to exert their action towards successful revascularization of the heart muscle.~      An amino acid called L-arginine has repeatedly been shown to markedly improve function of the~     coronary artery lining in patients with ischemic heart disease when administered regularly~     over a period of several months. This research will therefore test, in the form of a~     randomized clinical trial, whether this concomitant approach can make angiogenesis effective~     in patients with advanced coronary disease, by allowing for the action of growth factors to~     take place in the heart. If this approach is successful, as is anticipated, angiogenesis will~     constitute an effective modality for the treatment of coronary artery disease, not only in~     patients with advanced, severe involvement unamenable to any other form of cardiac therapy~     such as coronary artery bypass grafting, but even perhaps in all patients with coronary~     artery disease in need of revascularization. The goal of this investigation towards the~     making of a new, revolutionary, safe and efficacious modality for the treatment of the number~     one killer disease of Canadians is in complete agreement with the primary objective of the~     Heart and Stroke Foundation of Canada.~   "
260916|NCT00134420|"~     We, the investigators at the University of Texas Health Science Center at San Antonio, want~     to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH)~     treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous~     study showed that growth hormone improved height in all children with 18q- and growth hormone~     deficiency. In addition, most of the study participants on growth hormone treatment showed an~     increase in IQ scores.~   "
260917|NCT00134407|"~     Complete fasting until resumed bowel function after upper abdominal surgery is not~     beneficial. Enteral feeding has been claimed to be the preferred way of delivering~     nutritional support postoperatively. Increasing evidence suggests that letting patients eat~     (voluntary oral feeding or oral intake at will) from the day after the operation is safe.~     No prospective randomised trial has been undertaken to compare these two regimens. In this~     study, the investigators will randomise 444 patients, subject to major upper abdominal~     surgery, into receiving either continuous enteral feeding by needle catheter jejunostomy~     until resumed bowel function, or to oral intake at will from postoperative day 1. The main~     endpoints are the incidence rate of major complications and death, as well as a Quality of~     Life assessment.~      Null-Hypothesis:~      Routine postoperative feeding by needle catheter jejunostomy after major, upper abdominal~     surgery has no clinically relevant advantages over early oral intake at will.~   "
260918|NCT00134394|"~     The study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (SQ) weekly~     plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus~     placebo ointment twice daily.~   "
260919|NCT00134381|"~     The purpose of this study is to investigate whether topically applied constituents of green~     tea [caffeine or (-)-epigallocatechin gallate; EGCG] have a protective effect on skin exposed~     to ultraviolet light (UV).~   "
260920|NCT00134368|"~     The purpose of this study is to investigate the efficacy and safety of etanercept in adults~     with vitiligo.~   "
260921|NCT00134355|"~     The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood~     vessel growth, in the treatment of patients with non-metastatic androgen independent prostate~     cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate~     serum vascular endothelial growth factor (VEGF) levels.~   "
263902|NCT00094185|"~     To identify genetic variants in 12 key blood clotting proteins that may modify the risk of~     venous thromboembolism in users of hormone replacement therapy.~   "
260922|NCT00134342|"~     The tuberculin skin test (TST) has been the gold standard for diagnosing latent tuberculosis~     for almost 100 years. While this test performs reasonably well in healthy, non-bacille~     Calmette-Guerin (BCG) vaccinated populations, it is believed to perform less well in patients~     who do not have intact cellular immune systems (immunocompromised).~      The investigators hypothesize that a new test, the T-SPOT TB ELISPOT test will provide a more~     accurate measurement of latent infection in immunocompromised people. This study will compare~     the TST to the T-SPOT TB ELISPOT test, and to the results of an expert physician diagnostic~     panel.~   "
260923|NCT00134329|"~     This study consists of filling out a questionnaire on possible erectile dysfunction.~   "
260924|NCT00134316|"~     Aim #1. To investigate the efficacy of the psychoeducational intervention (PED) on sexual~     arousal.~      H1: Compared to a control group and to baseline, PED will result in significant improvement~     in:~        -  self-reported subjective sexual arousal;~        -  self-reported genital sensitivity;~        -  psychophysiological sexual arousal.~      Aim #2. To investigate the efficacy of the PED on self-reported orgasm, sexual desire,~     distress, and relationship satisfaction.~      H2: Compared to a control group and to baseline, PED will result in significant improvement~     in self-reported orgasmic experience, sexual desire, sexual distress, and relationship~     satisfaction.~      Aim #3. To investigate the efficacy of the PED on depressive symptoms and quality of life.~      H3: Compared to a control group and to baseline, PED will result in significant improvement~     in self-reported depressive symptoms and quality of life.~   "
260925|NCT00134303|"~     This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery~     for obesity.~   "
260926|NCT00134290|"~     This is a study to:~        -  Determine the difference between strong hypo-energetic standard diet advice and modest~          hypo-energetic personal diet advice; and~        -  Determine the influence of insulin-insensitivity on obesity and weight reduction by~          treating patients with metformin or placebo.~   "
260927|NCT00134277|"~     This study is a comparison of different medical devices for infragenual dilatation.~   "
260928|NCT00134264|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular~     disease events, when compared to atorvastatin alone, in patients with coronary heart disease~     or risk equivalents~   "
260929|NCT00134251|"~     This study is a multicenter, randomized, double-blind, placebo controlled, parallel group~     study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in~     patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations.~     Patients (outpatients) will be randomized to one of three different treatment arms.~   "
260930|NCT00134238|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To look at ultrasound images taken in the carotid arteries and to look at various lipids in~     the blood of people with mixed hyperlipidemia~   "
260931|NCT00134225|"~     The investigators hypothesize that non able-bodied participants with reported acute,~     sub-acute, or chronic symptoms of neck or back pain of a musculoskeletal origin will have~     magnetic resonance imaging (MRI), X-ray and blood parameters that do not demonstrate a~     statistical difference between “normal” (able-bodied) volunteers.~      Muscle pattern recognition (MPR) testing will show statistically different results between~     these groups. This statistically significant finding in MPR results will enhance a~     clinician’s determination of clinical normality or abnormality.~      If this hypothesis is demonstrated, the MPR modality will be the first quantitative tool~     developed for assisting in the diagnosis of the presence or absence of a musculoskeletal~     dysfunction in a patient population. The availability of such an evaluation tool to a~     healthcare provider for patients with soft tissue, non-surgical neck or back complaints will~     substantially improve the accuracy of diagnosis and case management decisions.~   "
260932|NCT00134212|"~     In septic shock, when volume resuscitation fails to restore mean arterial pressure,~     catecholamines such as dopamine, dobutamine, epinephrine, or norepinephrine are used, either~     alone or in combination. Although they allow hemodynamic success to be obtained, they can~     leave some regional blood flows impaired, especially the hepatosplanchnic perfusion, which~     contributes to multiple organ failure.~      Dopexamine is a structural and synthetic analog of dopamine that exerts systemic and gut~     vasodilation and stimulates cardiac contraction. In experimental models, dopexamine has been~     shown to exert anti-inflammatory properties and to protect the hepatic ultra structure. The~     combination of dopexamine and norepinephrine could therefore constitute an interesting~     alternative in treating septic shock patients. This study will test the efficacy (on gastric~     mucosal blood flow, hepatic damage and oxidative stress) and safety of the combination of~     dopexamine and norepinephrine (compared to those of epinephrine alone) in the treatment of~     patients with septic shock.~   "
260933|NCT00134199|"~     To evaluate the effect of 6-month administration of CP-945,598 on:~        -  weight loss and waist circumference,~        -  blood pressure, cholesterol, glucose~        -  other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-Î±~          and hsCRP~        -  the relationship between the concentration of the drug on the blood and the above~          parameters~        -  physical and psychosocial functioning, weight related symptoms, treatment satisfaction,~          appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression~   "
260934|NCT00134186|"~     The purpose of this study is to find out if renal cell (kidney) cancer that has spread to~     other parts of the body will respond to treatment with motexafin gadolinium (MGd).~   "
260935|NCT00134173|"~     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.~      To look at ultrasound images taken in the blood vessels of the heart and to look at various~     lipids in the blood of people with known coronary heart disease~   "
260936|NCT00134160|"~     The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker~     (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more~     effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk~     hypertensive patients not adequately controlled by standard dose ARB alone.~   "
260937|NCT00134147|"~     To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes~     who are not well controlled on 2 or more oral anti-diabetic agents~   "
264009|NCT00092716|"~     The purpose of this study is to determine whether an investigational medication will be more~     effective than an approved medication in reducing cholesterol levels.~   "
260940|NCT00134095|"~     RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Giving chemotherapy before surgery may shrink the tumor so that it can be completely removed.~      PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works~     in treating patients who are undergoing surgery for locally advanced stomach cancer.~   "
260941|NCT00134082|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as cyclophosphamide, work in different ways to stop the growth of cancer cells either by~     killing the cells or by stopping them from dividing. Vaccines made from another person's~     cancer cells may help the body build an effective immune response to kill cancer cells.~     Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells~      PURPOSE: This phase I/II trial is studying how well giving rituximab together with~     cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin~     lymphoma.~   "
260942|NCT00134069|"~     This phase I/II trial is studying the side effects and best dose of sorafenib when given~     together with cetuximab and irinotecan and to see how well they work in treating patients~     with advanced or metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to~     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances~     to them. Sorafenib and cetuximab may also stop tumor growth by blocking blood flow to the~     tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to kill tumor~     cells, either by killing the cells or by stopping them from dividing. Giving sorafenib~     together with cetuximab and irinotecan may kill more tumor cells~   "
260943|NCT00134056|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective~     than docetaxel and prednisone in treating prostate cancer.~      PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to~     see how well they work compared to docetaxel and prednisone in treating patients with stage~     IV prostate cancer and bone metastases that did not respond to previous hormone therapy.~   "
260944|NCT00134043|"~     This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating~     patients with metastatic and/or locally advanced or locally recurrent thyroid cancer. Drugs~     used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
260945|NCT00134030|"~     This randomized phase III trial is studying combination chemotherapy followed by surgery and~     two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to~     compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with~     the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the~     tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon~     alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving~     combination therapy together with PEG-interferon alfa-2b is more effective than two different~     combination chemotherapy regimens alone after surgery in treating osteosarcoma.~   "
260946|NCT00134017|"~     RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of~     cancer and abnormal cells and helps stop the patient's immune system from rejecting the~     donor's stem cells. When the healthy stem cells from a donor are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets. Sometimes the transplanted cells from a donor can make an immune response~     against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, or~     tacrolimus after transplant may stop this from happening.~      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together~     with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a~     donor bone marrow transplant for hematologic cancer.~   "
260947|NCT00134004|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and~     radiation therapy before a donor bone marrow transplant helps stop the growth of cancer~     cells. Giving chemotherapy or radiation therapy before or after transplant also stops the~     patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem~     cells may replace the patient's immune system cells and help destroy any remaining cancer~     cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also~     make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate~     mofetil after the transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide~     together with total-body irradiation works in treating patients who are undergoing a donor~     bone marrow transplant for hematologic cancer.~   "
260948|NCT00133991|"~     RATIONALE: Drugs used in chemotherapy, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells~     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Giving combination chemotherapy together with rituximab may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or~     leukemia.~   "
260949|NCT00133978|"~     The purpose of this study is to determine whether providing high dose glutamine and~     antioxidants to critically ill patients will be associated with improved survival.~   "
260950|NCT00133965|"~     This is an international, 3-site trial (Winnipeg Canada, MSKCC NYC, Perth Australia) accruing~     120 patients per site (120x3). The purpose of this study is to compare two types of~     counseling for cancer patients: Dignity Psychotherapy and Supportive Psychotherapy as~     well as Standard Palliative Care. Many cancer patients seek counseling to help with the~     emotional burden of their illnesses. Counseling often helps them cope with cancer by giving~     them a place to express their feelings. We, the investigators at Memorial Sloan-Kettering~     Cancer Center, have developed a type of counseling we call Dignity Psychotherapy. It is~     intended to help cancer patients maintain or enhance a sense of purpose, meaning, and overall~     quality of life, despite having cancer. Supportive Psychotherapy is another type of~     counseling intended to help patients feel more at ease and express and reflect on any~     feelings or concerns they might have about their illness. Both of these types of counseling~     will be compared to Standard Palliative Care. We will look at how these types of treatments~     affect patients' mood, outlook, and quality of life. We also want to see how the type of~     treatment they receive affects their family members and significant others.~   "
260951|NCT00133952|"~     The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin~     will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with~     clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from~     baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity~     that is sustained for the patient's last 6 months of study participation. The SMVL data from~     this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of~     comparing ruboxistaurin to placebo.~   "
260952|NCT00133939|"~     Synchronism of gas flow delivered by the ventilator and muscular effort of the patient will~     be studied during two kinds of ventilation. The first one is the proportional assisted~     ventilation during which the gas flow is theoretically adapted to the patient's muscular~     effort within the breath. The second is the pressure support ventilation during which the gas~     flow is delivered to maintain the inspiratory pressure stable. The hypothesis is that the~     first mode allows a better synchronism.~   "
260953|NCT00133926|"~     The aim of the study is to investigate, in an Australian population of pregnant women,~     whether the treatment of periodontal disease during pregnancy prevents pre-term birth and~     other complications of pregnancy. Dental screening and periodontal treatment protocols have~     been based on standard techniques employed by hygienists that can be readily applied to the~     general obstetric population.~   "
260954|NCT00133913|"~     This study enrolled patients with measurable metastatic colorectal cancer. Blood was drawn~     prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14~     days, 3-4 weeks, and when an imaging study was done (~every 6 to 12 weeks). The blood was~     tested to find circulating tumor cells (CTCs) and to count them. The CTC levels were compared~     to the imaging study results to see if the CTC number and the imaging result (progression/no~     progression) were in agreement. Maximum active study participation was 12 months with up to 8~     blood draws being taken. All patients are currently being followed for up to 24 months from~     their off study date for survival. The CTC result will also be used to see if there is a~     difference in survival and progression-free survival for those patients with and without a~     certain number of CTCs.~   "
260955|NCT00133900|"~     This study enrolled men with prostate cancer who had failed hormone therapy (as shown by~     rising prostate-specific antigen [PSA] levels) and who were about to start a new line of~     chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly~     thereafter for up to 18 months or until disease progression, whichever occurred first. The~     blood was tested to find circulating tumor cells (CTC) and to count them. The circulating~     tumor cell levels were studied in relation to the patient's overall survival. Serum was also~     collected for PSA testing, and additional blood samples were drawn to test for circulating~     endothelial cells and RNA was isolated for future gene expression testing.~   "
260956|NCT00133887|"~     In a population of kidney transplant recipients having developed a first squamous cell~     carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2~     years in patients who are switched to rapamycin as compared to patients who are maintained~     under calcineurin inhibitors.~   "
260957|NCT00133874|"~     The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and~     effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and~     children as young as 9 months of age.~   "
260958|NCT00133861|"~     The aim of the study is to confirm the functional improvement obtained through treatment of~     spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both~     muscles gives a better and longer functional improvement than treatment of only one muscle.~     The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum~     toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level,~     functional scales and subjective feeling) and gait analysis data (kinematics and kinetics~     data) are collected. Evaluations take place before treatment, 2 months and 6 months after~     treatment.~   "
260959|NCT00133848|"~     The goal of this study is to determine if topical SB-275833 ointment, 1% is more effective~     than a placebo ointment in the treatment of primary impetigo.~   "
260960|NCT00133835|"~     Endoscopy is an established method of treatment for painful obstructive calcified~     pancreatitis. It involves the disintegration of calcifications using extracorporeal shock~     wave lithotripsy (ESWL) followed by endoscopic removal of stone fragments possibly associated~     with stent insertion. A pilot study suggests that ESWL alone relieves pain in calcified~     chronic pancreatitis (CP). The aim of this study is to compare both techniques in a~     randomized controlled trial.~   "
260961|NCT00133822|"~     The purpose of this study is to determine whether the administration of risperidone is~     effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant~     post-traumatic stress disorder (PTSD) in civilians.~   "
260962|NCT00133809|"~     This trial will study the ability of islet transplantation to restore glycemic control and~     achieve insulin independence in type 1 diabetic subjects with life-threatening hypoglycemia~     and unawareness, or recurrent hyperglycemia with ketoacidosis.~   "
260963|NCT00133796|"~     The purposes of this study are to better understand how Herceptin causes tumors to become~     smaller and to find out how effective Herceptin, together with chemotherapy, is in treating~     advanced breast cancer.~   "
260964|NCT00133783|"~     Calcitonin, calcitonin gene-related peptides (CGRPs), adrenomedullin, and amylin belong to a~     unique group of peptide hormones important for the regulation of calcium balance,~     neurotransmission, cardiovascular homeostasis, and glucose metabolism. We, the investigators~     at Chang Gung Memorial Hospital, recently identified intermedin as a novel peptide hormone~     belonging to this unique peptide ligand family. Adrenomedullin is a 52-amino-acid peptide and~     is one of the most potent vasodilators. Plasma adrenomedullin is elevated in a variety of~     pathological conditions such as hypertension, renal failure, heart failure, and septic shock.~     CGRPα and CGRPβ are 37-amino acid neuropeptides; primarily release from sensory nerves; and~     play important roles in regulating peripheral vascular tone and controlling blood flow in~     various organs. Human mature intermedin encodes 40-amino-acid and is expressed mainly in the~     adrenocorticotrophs of the anterior and intermediate pituitary lobe. Intermedin signals~     through calcitonin receptor-like receptor (CRLR)/receptor activity-modifying protein (RAMP)~     receptor complexes, and CRLR/RAMP signaling has been proven to be critical for vascular tone~     regulation. Based on this finding, we had documented that intraperitoneal administration of~     intermedin dose-dependently suppressed blood pressure in normal Sprague-Dawley rats. In~     addition, our preliminary in vitro and in vivo studies demonstrated that ovariectomy lead to~     a tenfold reduction of intermedin transcript expression in the pituitary in rats whereas~     subsequent estrogen treatment increased pituitary intermedin expression to a level similar to~     that of intact rats. Taken together, we propose that pituitary-derived intermedin is~     regulated by estrogen and exhibits potent hypotensive effects. To address this hypothesis, in~     Specific Aim 1, we will investigate the regulation of secretion and expression of intermedin~     in vitro and in vivo using cultured pituitary cells and oophorectomized rats. In Specific Aim~     2, we will study the molecular mechanism by which estrogen stimulates intermedin gene~     expression. In Specific Aim 3, to demonstrate that the estrogen-dependent regulation of~     intermedin represents a critical link in the regulation of blood pressure in women, we will~     study the relationship between blood pressure and blood intermedin levels using a~     cross-sectional study. Our studies will provide a better understanding of the mechanisms by~     which sex hormones modulate blood pressure and open a new window for postmenopausal~     hypertension treatment.~   "
260965|NCT00133770|"~     The aim of this study is to examine whether pantoprazole (Protonix) given through continuous~     intravenous infusion for 72 hours is superior to Protonix given through once a day IV~     injection in the treatment of erosive esophagitis.~   "
260966|NCT00133757|"~     In this study we, the investigators at the Centre for Addiction and Mental Health, intend to~     explore whether bupropion is able to reduce smokers' responses to cigarette-related~     environmental cues, and craving. Previous studies have indicated that bupropion may be able~     to achieve these outcomes. Therefore, we predict that smokers treated with bupropion for~     several weeks will show reduced reactivity to cigarette cues and craving.~   "
260967|NCT00133744|"~     The purpose of this study is to determine whether a daily prenatal supplement of iron plus~     folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women~     from their first prenatal visit through delivery reduces perinatal mortality compared with a~     daily prenatal supplement of folic acid alone.~   "
260968|NCT00133731|"~     The objective of this dose-ranging study is to determine the effects of several intravenous~     (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and~     coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.~   "
260969|NCT00133718|"~     The purposes of this study are:~        -  to investigate the extent of cardiovascular complications in a representative cohort~          (n=135) of adult patients with type 2 diabetes;~        -  to examine if modern non-invasive assessment can replace invasive assessment;~        -  to determine the effects of a 6 month lifestyle interventional program on weight,~          glycemic control and lipids in 60 patients;~        -  to determine the effect of a 2-year prospective, randomised multi-interventional program~          (n=120) on cardiovascular risk, anthropometric measures and glycometabolic control; and~        -  to investigate inflammatory markers in this setting.~   "
260970|NCT00133705|"~     The purpose of this trial is to determine if low-dose mifepristone benefits women with~     symptomatic fibroids.~   "
260971|NCT00133692|"~     Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is~     important to keep it as normal as possible. There are several different ways to control blood~     pressure and to prevent or limit the development of heart disease due to high blood pressure.~     The purpose of this study is to compare two treatments to see how well they work and the~     difference in their side effects. One treatment includes the use of a calcium antagonist drug~     (Isoptin sustained release [SR] or Verapamil SR). The other treatment excludes the calcium~     antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or~     Atenolol). Both treatments may also include medication called angiotensin converting enzyme~     (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are~     all approved by the Food and Drug Administration (FDA).~   "
260972|NCT00133679|"~     The purpose of this study is to test if sildenafil is effective in the treatment of infants~     with severe congenital diaphragmatic hernia (determined by the presence of prolonged~     pulmonary hypertension or prolonged oxygen supplementation on mechanical ventilation), as~     measured by the estimated pulmonary artery systolic pressure following treatment.~   "
260973|NCT00133666|"~     The purpose of this study is to determine if teaching children with asthma how to talk to~     their doctor about controlling their asthma including symptom frequency in an asthma diary~     and medication use techniques, will result in less symptom and missed school days, fewer~     emergency room visits and reduce the cost of asthma health care.~   "
260974|NCT00133653|"~     Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have~     previously been associated with a sustained increase in blood pressure (BP).~      In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we, the~     researchers at Sunnybrook and Women's College Health Sciences Centre, evaluated whether JS~     and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in~     subjects enrolled with normal or untreated high BP.~   "
260975|NCT00133640|"~     The aim of this study is to compare a low versus high intensity physiotherapy early~     rehabilitation program combined with a low versus high dose vitamin D early rehabilitation~     program in a randomized controlled trial among elderly patients with acute hip fracture in an~     acute care setting. The primary outcome to be compared between treatment arms is the rate of~     falls during a 12-month follow-up. Secondary outcomes are injurious falls, number of persons~     who fell, low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur,~     tibia), disability, quality of life (Euro-Qol), mortality and health care utilization.~     Another secondary outcome will be admission to nursing home compared between treatment arms~     among subjects, who are community-dwelling prior to the index hip fracture. Admission to~     nursing home is the marker of loss of independence for the individual, but also triggers high~     cost for the society.~      The study will provide new early rehabilitation guidelines to allocate health care resources~     efficiently in the acute care setting. Eventually and most importantly, the study will help~     improve outcomes in patients with hip fractures.~   "
260976|NCT00133627|"~     Medications available for the treatment of seasonal allergic conjunctivitis include~     antihistamines. These medicines block the release of histamine, a substance in the body that~     is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop~     formulation of a well tried antihistamine called ketotifen. This study will compare the~     efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular~     treatment for seasonal allergic conjunctivitis in China.~   "
260977|NCT00133614|"~     The purpose of this trial is to test the hypothesis that at the end of 28 days, infants and~     children with acute lung injury treated with prone positioning would have more~     ventilator-free days than those treated with supine positioning.~   "
260978|NCT00133601|"~     This study of cognitive behavioral therapy for insomnia in chronic pain patients is a~     randomized, controlled clinical trial of parallel groups with three and six months follow up.~   "
260979|NCT00133588|"~     The purpose of this study is to evaluate a new method of detecting the flu infection. This~     method may allow researchers to identify new proteins being made in response to an infection~     even before symptoms of the infection are present. The goal of this study is not to prevent~     the flu but to monitor the immune system response. The elderly and those with chronic health~     problems are at greater risk for complications (i.e., pneumonia, bronchitis [bacterial~     infection in the lungs], and sinusitis [bacterial infection in the sinuses]) from the flu.~     Early detection and diagnosis of the flu decreases the number of people with these~     complications. Participants will include healthy people between the ages of 21-40, between~     the ages of 60-89, or 90 years and older, who are living in the communities surrounding the 3~     study sites in Virginia. There will be 5 study visits, and subjects will participate up to 1~     month.~   "
260980|NCT00133575|"~     The purpose of this study is to assess the safety of an experimental smallpox vaccine (MVA:~     Modified Vaccinia Ankara) and to compare the body's immune (system that fights disease)~     response to this vaccine. Participants will be assigned to 1 of 6 study groups. Each group~     will include 12 subjects, 10 will receive the modified smallpox vaccine and two will receive~     placebo, an inactive substance. The vaccine will be administered in 1 of 3 ways: under the~     skin; in the muscle; or between the muscle and the skin. Groups A and B will receive Dryvax®~     6-15 months after the initial MVA vaccine; groups C, D, E, and F will receive Dryvax® 6~     months after the initial MVA vaccine. Study procedures will include documenting side effects~     for 14 days after each vaccination, electrocardiogram (picture of the hearts activity) and~     blood samples. Participants will be involved in study related procedures for up to 18 months.~   "
260981|NCT00133562|"~     This study will determine the effect of 7 days supplementation of alanyl-glutatime or glycine~     on the damaged intestinal barrier function on day 8 in children with persistent diarrhea or~     malnutrition.~   "
260982|NCT00133549|"~     The purpose of this study is to evaluate the safety and immune response of a conjugated~     pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in~     elderly adults. Study participants will include 180 adults, 65 years of age or greater.~     Participants will be randomly assigned to 1 of 3 possible groups. Subjects will maintain a~     study diary to record side effects and oral temperatures for 7 days following each~     vaccination. Blood samples will be collected before and 1 month following each dose of~     vaccine or placebo. Participants will be involved in study related procedures for up to 268~     days.~   "
260983|NCT00133536|"~     The purposes of this study are: to make sure that there are no serious side effects of an~     experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's~     immune system reacts to the vaccine. To look at the side effects, researchers will follow~     children closely after vaccination. To look at immune system responses, researchers will test~     the children's blood before and a number of times after vaccination. Participants will~     include up to 130 healthy children ages 2-9 years. Participants will be assigned to receive~     2, up to 3 doses of vaccine, or placebo (inactive substance). Subjects will receive at least~     2 doses of vaccine approximately 28 days apart. If data shows an enhanced immune response~     from a third vaccination, children will be offered a third dose of the vaccine. Participants~     will be involved in study related procedures for up to 13 months, including up to 6 study~     visits, plus a number of telephone calls.~   "
260984|NCT00133523|"~     The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo~     (inactive substance). The study will be conducted among healthy adult participants aged 18-49~     years and is expected to last 3 years. During year 1, participants will be assigned to~     receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray~     (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo).~     Participants will receive the same assigned vaccine or placebo during year 2. During year 3,~     participants will be followed, but will not receive flu vaccine. Each year blood samples will~     be collected before and 1 month after each vaccination and at the end of each flu season in~     order to measure how the body responds to the vaccine and how well participants were~     protected from the flu. During the flu season, participants with flu-like illness will~     provide information on symptoms and provide a throat swab to test for virus identification.~   "
260985|NCT00133510|"~     The purpose of this study is to evaluate how well children responds to the recommended~     trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and~     receive their post-transplant care at Mount Sinai and their siblings are being invited to~     participate in this study. Study procedures will include a review of medical records,~     physical examination, and up to 2 flu shots. All participants will receive the flu vaccine.~     Four weeks after the first flu shot, participants will return to the clinic for a physical~     exam, blood sample collection, and a second flu shot as recommended. Following each~     vaccination, parents will be asked to record their children's temperatures and any~     experienced side effects in a diary card for two weeks. Participants will be involved in~     study related procedures for up to 8 months.~   "
260996|NCT00133367|"~     The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and~     sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy~     followed by donor cord blood transplantation.~   "
260997|NCT00133354|"~     The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal~     fusion and increase predicted adult height in boys who are growth hormone deficient, in~     puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year~     trial.~   "
260986|NCT00133497|"~     The purpose of this research study is to test the safety of and the body's response to an~     experimental cytomegalovirus (CMV) vaccine (called gB/MF59 vaccine). Participants will~     include approximately 400 healthy females, ages 12-17, recruited from adolescent clinics at~     Cincinnati Children's Hospital Medical Center, Vanderbilt University Medical Center, Baylor~     College of Medicine, University of Texas School of Public Health, Houston, and the University~     of Texas Medical Branch at Galveston. Participants will receive 3 doses of vaccine or placebo~     (saltwater) on a 0, 1, and 6 month schedule. Study procedures will include blood and urine~     samples. Participants will complete a diary recording temperatures and any side effects~     experienced. Subjects will be involved in study related procedures for up to 31 months.~   "
260987|NCT00133484|"~     Objectives are: To confirm the safety and tolerability of 2-dose regimens of 100 g rPA~     vaccines (3 products) administered by the intramuscular (IM) route to healthy adults.To~     describe the immunologic responses to 2-dose regimens of 3 rPA vaccines and to compare the~     responses to those following administration of Anthrax Vaccine Adsorbed (AVA or BioThraxTM),~     the currently available vaccine. The primary immunologic outcome is the proportion of~     volunteers in each group that mounts an antibody response (defined as a 4-fold or greater~     increase from pre-vaccination to post-vaccination of anti-rPA IgG antibody with a minimal~     concentration of 10 µg/ml as measured by ELISA). Secondary outcomes are time to peak response~     and GMC of anti-PA antibody at peak for each group. In addition, the following immunologic~     assays will be performed: toxin neutralization assay, oral fluid ELISA, antibody avidity, IgG~     subclasses, and B-cell memory,T-cell memory and effector subpopulations.~   "
260988|NCT00133471|"~     The purpose of this study is to compare the body's reactions and immune responses after~     receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant~     given into the arm muscle. Study participants will include up to 96 healthy adults, ages~     18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the~     following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be~     vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for~     7 days following each vaccination. Participants will return to the clinic on days 2 and 7~     after vaccination. Blood samples will be collected 7 days following each vaccination. Serum~     and nasal wash specimens will be collected before each vaccination and 4 weeks after~     injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for~     up to 8 months.~   "
260989|NCT00133458|"~     This study will enroll 120 individuals diagnosed with subarachnoid cysticercosis, a disease~     caused by the invasion of the basal part of your brain by a parasite named Taenia solium.~     Subarachnoid cysticercosis is usually treated with albendazole for one month to kill the~     parasite. This study will determine if two months of albendazole (ABZ) therapy is better than~     one-month. The study will last 3 years.~   "
260990|NCT00133445|"~     The purpose of this study is to evaluate the safety of administering a combination vaccine~     (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration~     of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age.~     Additionally, researchers will assess the body's antibody response (proteins produced by the~     body's immune system that help fight infections) following each vaccine dose. The study will~     enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related~     procedures for up to 288 days, including blood sample collection and 5 study visits.~   "
260991|NCT00133432|"~     Undernutrition in children less than five years of age is common throughout sub-Saharan~     Africa. Nutritional deficiencies may lead to less ability to fight infectious diseases. The~     purpose of this study is to determine whether zinc supplements plus standard antibiotics~     reduce the length of hospitalization in children with pneumonia. Six hundred children aged~     6-36 months diagnosed with pneumonia and admitted to Muhimbili National Hospital (MNH), Dar~     es Salaam, Tanzania, will participate in this study. Half of the children will receive daily~     supplements of zinc, and the other half will receive placebo tablets (dummy pills containing~     no medication). Each child will be followed for 6 weeks after hospital discharge to check for~     recovery from the illness. All children in both groups will receive antibiotics and~     supportive care to manage pneumonia, according to the standards of care at MNH and Amana~     Municipal Hospital in accordance with the Recommendations of the Ministry of Health,~     Tanzania.~   "
260992|NCT00133419|"~     The purpose of the study is to see if giving vitamin and mineral supplements helps to protect~     infants and children from diarrhea, which vitamins and minerals help to improve a child's~     weight and growth, and if the same results occur in infants and children with HIV. HIV is the~     virus that causes AIDS. Study participants will include 516 infants aged 4-6 months.~     Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with~     HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects~     will have an equal chance of receiving one of three different vitamin and/or mineral~     supplements during the study. Study procedures will include up to 7 blood samples and stool~     samples every 3 months and body composition every 6 months. Participants will be involved in~     the study for up to 18 months.~   "
260993|NCT00133406|"~     The primary objectives of this study are to determine the effect of 1 year supplementation of~     Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score~     (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in~     children living in a Brazilian slum. Study participants will include 280 children ages 2~     months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque~     Universitario community, living in Brazilian favela. There is also a sub study to determine~     if ten days of glutamine delivered as an oral bolus improves the health of the digestive~     system.~   "
260994|NCT00133393|"~     The primary objectives of this study is to identify a safe, tolerable dose of pentoxifylline~     in children with cerebral malaria and to establish an acceptable pentoxifylline dosage~     regimen for use in multi center Phase II and Phase III studies.~   "
260995|NCT00133380|"~     The purposes of this study are to determine:~        -  The safety of the study medication and any side effects that might be associated with it~        -  Whether the study medication can help patients with high levels of bad cholesterol~          (low-density lipoprotein-cholesterol [LDL-C]), alone or in combination with additional~          study medication~   "
260998|NCT00133341|"~     It is the purpose of this study to determine the concentration of 3 allergens~     (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing~     allergic contact dermatitis.~   "
261000|NCT00133315|"~     The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients~     who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated~     patients the researchers want to identify better biomarkers for disease activity and disease~     progression. In addition, the researchers want to identify predictors for disease~     progression.~   "
261001|NCT00133302|"~     The purpose of this trial is to investigate the clinical benefit of the dose intensified~     regimen, Bi-CHOP in comparison to standard CHOP for advanced intermediate or high grade~     non-Hodgkin's lymphoma (NHL).~   "
261002|NCT00133289|"~     The ULTRA study will assess the difference in average ventricular voltage output for~     pacemaker patients randomized to Automatic Capture feature ON versus patients randomized to~     Automatic Capture feature OFF.~   "
261003|NCT00133276|"~     The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but~     is hampered by peginterferon-induced psychopathology.~      Prevention of peginterferon-induced psychopathology with selective serotonin reuptake~     inhibitors (SSRI's) (paroxetine) has been shown to be effective in patients treated with~     interferon for malignant disease. The aim is to study the effects of prophylactic treatment~     with escitalopram (another SSRI) on peginterferon-associated psychopathology in patients~     treated with peginterferon and ribavirin for chronic hepatitis C.~   "
261004|NCT00133263|"~     The purpose of this study is to evaluate the efficacy of Primary Bereavement Care (PBC) -a~     standardized bereavement intervention- delivered by family physicians (FP), in widows.~   "
261005|NCT00133250|"~     The purpose of this study is to assess whether abciximab is associated with additional~     benefit in patients with AMI treated with PCI after high dose clopidogrel loading.~   "
261006|NCT00133237|"~     The purpose of this study is to evaluate the efficacy of sirolimus- and paclitaxel-eluting~     stents for treatment of unprotected left main coronary artery disease.~   "
261007|NCT00133224|"~     The primary objective of this study is to compare the duration of survival between patients~     receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients~     receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer~     respond to hormone therapy, who have documented metastases with pain. Patients may have had~     up to one prior non-taxane chemotherapy treatment.~   "
261008|NCT00133211|"~     Atrial fibrillation is the most common heart arrhythmia afflicting approximately 1% of the~     Danish population. Medical antiarrhythmic treatment is only moderately effective and has the~     risk of severe side effects. The present study is a prospective, randomized, multicentre~     study comparing medical antiarrhythmic drug strategy with catheter based radiofrequency~     strategy in patients with paroxysmal atrial fibrillation. The primary end point is atrial~     fibrillation burden (symptomatic and asymptomatic) judged by multiple 7-day Holter~     monitorings during 2 years follow-up. Three hundred patients considered candidates for~     antiarrhythmic drug treatment will be randomized. The study will be performed as a~     Scandinavian/German multicentre study.~   "
261009|NCT00133198|"~     A 12 week clinical trial was conducted in the United States in order to compare pramipexole~     (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in~     adult subjects.~   "
261010|NCT00133185|"~     The primary objective of this trial is to compare the efficacy and safety of telmisartan 40~     mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide~     12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate~     hypertension.~   "
261011|NCT00133172|"~     The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day~     steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.~   "
261012|NCT00133159|"~     Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities~     of an allergen extract to an allergic patient, is a curative approach which directly treats~     the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal~     specific immunotherapy for patients with an allergy to grass pollen (hay fever). The purpose~     of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of~     different doses of GrassMATAMPL in volunteers allergic to grasses and rye pollen.~   "
261013|NCT00133146|"~     Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities~     of an allergen extract to an allergic patient, is a curative approach which directly treats~     the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal~     specific immunotherapy for patients with an allergy to grass and rye pollen (hay fever).~      The tolerability and immunogenicity of GrassMATA (allergen modified with glutaraldehyde and~     adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a~     bacterial cell surface) is being investigated in this double-blind, randomized Phase IIa~     study in volunteers allergic to grass and rye pollen.~      Additionally, this study will assess residual allergenicity of the modified grass and rye~     pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass~     and rye pollen.~   "
261014|NCT00133133|"~     Postoperative pain after gall bladder removal can be significant, mobility limiting and~     extend hospital stay. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine~     that has the potential for long-term pain relief following a single administration. This~     study will determine whether ALGRX 4975 can provide pain relief following gall bladder~     removal.~   "
261015|NCT00133107|"~     This study is to determine whether efalizumab 1.0mg/kg given by subcutaneous injection for 12~     weeks is effective in treating oral lichen planus.~      This is a 20 week, single center, open-label pilot study to enroll 5 subjects.~   "
261016|NCT00133094|"~     Employing a physician-directed case management system, utilizing a Certified Registered Nurse~     Practitioner (CRNP) in conjunction with computer-based decision support technology (CDST)~     will result in significantly lower total cholesterol and a lower low density lipoprotein~     cholesterol in a group of subjects enrolled in a general medical clinic compared to subjects~     managed by primary care providers in the usual care group.~   "
261017|NCT00133081|"~     The purpose of this study is to assess whether changing antiepileptic medication can reduce~     side effects and improve the quality of life in patients with epileptic seizures that are~     well controlled with antiepileptic drugs.~   "
261230|NCT00130299|"~     The primary aim of this study is to compare the effects of an experimental low-glycemic load~     diet with those of a conventional low-fat diet among obese young adults in an 18-month~     randomized-controlled trial.~   "
261018|NCT00133068|"~     A large number of African-American and low socioeconomic patients have poorly controlled high~     blood pressure because of not being able to take their high blood pressure medications. This~     puts these patients at higher risk of heart and kidney disease, stroke and death. This study~     is designed to reduce the barriers that prevent patients from taking their high blood~     pressure medications.~   "
261019|NCT00133055|"~     Sleep and discipline problems are the most common problems for parents of young children~     (ages 2 to 5 years old) and are the two concerns with the strongest relations to future child~     behavior problems. The Parenting Matters program combines treatment booklets and telephone~     support to help parents deal with sleep or discipline problems. Parents with concerns and who~     are interested in the study are identified during a visit to their family physician. We, the~     investigators at the University of Western Ontario, expect that parents receiving treatment~     booklets, along with usual care by their family physician, will have greater reductions in~     their child's sleep or discipline problems, improved parenting practices, and greater~     reductions in child behaviour problems after receiving the Parenting Matters intervention,~     compared to parents receiving usual medical care.~   "
261020|NCT00133042|"~     The purpose of this study is to determine whether the addition of omalizumab in patients with~     poorly controlled asthma (because of poor adherence) will decrease allergic airway~     inflammation and improve asthma control.~   "
261021|NCT00133029|"~     The purpose of this study is to determine whether the timing of prophylactic antibiotic~     administration for cesarean section (immediate preoperative versus intraoperative~     administration) impacts the rate of postoperative febrile morbidity. The specific aim of the~     project is to test the hypothesis that preoperative antibiotic administration will decrease~     the rate of composite postoperative febrile morbidity.~   "
261022|NCT00133016|"~     The purpose of this clinical trial is to investigate the efficacy of early amniotomy on~     reducing both the duration of labor and the frequency of dystocia in nulliparous women~     undergoing an induction of labor. This research project is a prospective, parallel clinical~     trial, in which subjects are randomized into one of two treatment groups: those who undergo~     early amniotomy and those who do not undergo early artificial rupture of the amniotic~     membranes.~   "
261023|NCT00133003|"~     The purpose of this study is to determine whether there is any additional benefit from~     abciximab administration during percutaneous coronary intervention in patients presenting~     with acute coronary syndromes after pre-treatment with 600mg of clopidogrel.~   "
261024|NCT00132990|"~     The purposes of this study are:~        -  to determine if bilateral pallidal deep brain stimulation results in improvement in neck~          postures/movements;~        -  to determine if bilateral pallidal deep brain stimulation results in improvement in~          quality of life; and~        -  to document the adverse effects of surgery in patients with cervical dystonia.~   "
261025|NCT00132977|"~     Patients with heart failure have a pumping action of the ventricles in which one ventricle~     contracts before the other ventricle. This uncoordinated (unsynchronized) pumping is due to a~     delay in the stimulation of the left ventricle because of its increased size. Pacing both the~     right and the left side of the heart (or cardiac resynchronization therapy [CRT]) has been~     proven to be effective in the treatment of heart failure (HF). Current market-approved~     devices combine both pacing (CRT) and shocking (implantable cardioverter defibrillator [ICD])~     therapy for patients who have severe heart failure and are at risk for developing~     life-threatening heart rhythms. These devices provide an electrical pacing stimulus to both~     ventricles and may help the heart contract in a more coordinated way and improve heart~     failure symptoms.~      The investigational portion of this trial involves the implantation of a market-approved CRT~     implantable cardioverter defibrillator (CRT-D) system in patients who do not meet the current~     criteria for a CRT implant. In order to receive a CRT-D implant today, patients must have~     heart failure symptoms, have a weakened heart muscle, and have uncoordinated pumping of the~     heart. To demonstrate this uncoordinated pumping of the heart, a test (electrocardiogram~     [ECG]) is done. It is believed that by using a different test (echocardiogram) to measure~     whether this uncoordinated pumping is present, more patients will be identified that will~     benefit from CRT-D therapy. This study will look at whether patients identified by using this~     echocardiogram test show a benefit from having this CRT-D therapy.~   "
261026|NCT00132964|"~     Acute ankle fractures are common in children. Most of these are stable and have a low risk of~     problems in the future. Even though these fractures are benign, these injuries are often~     casted for a fixed time period, which is inconvenient, expensive, and does not appear to be a~     practice that has been proven to be scientifically correct.~      Therefore, in this study, in healthy children with low-risk ankle fractures, we, the~     investigators at the Hospital for Sick Children, will examine if a removable ankle brace is~     at least as good as casting with respect to how well and how fast children return to their~     usual activities. In addition, we will compare the costs of each method for the patient and~     the health care system.~      Successful management of low-risk fractures with an ankle brace will allow for several~     advantages over the use of the cast. These advantages include the possibility of returning to~     normal activities faster, fewer visits to specialty hospital clinics, and significant cost~     savings.~   "
261027|NCT00132951|"~     The purpose of this study is to determine if 1 course of antibiotic treatment with~     telithromycin is superior to azithromycin in the treatment of lower respiratory tract~     infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired~     pneumonia (CAP) in the community setting.~   "
261042|NCT00132756|"~     The purpose of this research study is to test the safety, tolerability, and effectiveness of~     the drug combination of Doxil (doxorubicin) and estramustine when used to treat prostate~     cancer that is resistant to hormones and to a chemotherapy type called taxanes.~      The primary hypothesis is to reduce the measurable disease or prostate-specific antigen (PSA)~     level by at least 50% from baseline.~   "
261043|NCT00132743|"~     The purpose of this study is to compare the effectiveness of aortic stent surgery versus~     exercise therapy in individuals with aortoiliac insufficiency.~   "
261044|NCT00132730|"~     This is a study to evaluate the effectiveness and tolerability of a once-daily oral~     medication (MK-0873) for the treatment of COPD (chronic obstructive pulmonary disease) to~     determine whether the study drug leads to an improvement in pulmonary (lung) function, as~     well as symptoms, and quality of life.~   "
261028|NCT00132938|"~     Primary Objective:~        -  The primary objective of the study is to demonstrate the superiority of telithromycin~          over azithromycin and over cefuroxime axetil in the reduction of Streptococcus~          pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure~          (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit~          1).~      Secondary Objectives:~      The secondary objectives of the study are:~        -  To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime~          axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit~          in patients with Sp detected in sputum specimen at the start of the study (Visit 1);~        -  To compare the clinical cure rates achieved by each treatment group in the penicillin or~          erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp~          (SSp) population at the End of Therapy (EOT) and Test of Cure visits;~        -  To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of~          Therapy visit on the presence of Streptococcus pneumoniae strains resistant to~          beta-lactams or macrolides in the sputum of patients with Sp detected at the start of~          the study (Visit 1);~        -  To compare the clinical efficacy at the End of Therapy visit and safety at the Test of~          Cure visit of telithromycin, azithromycin and cefuroxime axetil in the global~          randomized population.~   "
261029|NCT00132925|"~     The purposes of this study are:~        -  To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared~          with placebo in children 2-5 years of age with perennial allergic rhinitis; and~        -  To assess the safety of Nasacort AQ 110 µg in children 2-5 years of age.~   "
261030|NCT00132912|"~     The object of the study is to determine whether different doses of SCH 530348, when added to~     standard medical care in persons undergoing percutaneous coronary intervention, will increase~     the risk of bleeding.~      A secondary objective is to determine whether patients treated with SCH 530348 have fewer~     cardiac events such as heart attack, bypass surgery, or death compared with those persons~     treated with the standard of care.~   "
261031|NCT00132899|"~     The primary objective is to compare the efficacy and safety of infliximab plus methotrexate~     to infliximab alone for the long-term control of signs and symptoms of Crohn's disease (CD)~     in patients with symptoms that are persistent enough to require corticosteroid therapy.~   "
261032|NCT00132886|"~     This study will look at how a single dose of study medication (tolvaptan) versus an inactive~     sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure.~     Higher than normal pressures can be related to symptoms of heart failure (shortness of~     breath, fatigue, etc.).~   "
261033|NCT00132873|"~     This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the~     OMC-SXB-7 open-label trial may be entered without any requirement as to length of~     participation in that trial.~      Approximately 70 patients are expected to participate at up to 6 investigative centers~     located in Canada. The trial will continue for up to 24 months or until marketing approval,~     whichever occurs sooner.~   "
261034|NCT00132860|"~     The purpose of the study is to investigate,﻿ in patients with moderate to severe chronic~     obstructive lung disease, whether intermittent antibiotic treatment leads to:~        -  A slower rate of decline in forced expiratory volume in one second (FEV1);~        -  A reduction in the frequency and severity of exacerbations;~        -  Fewer hospital admissions for chronic obstructive pulmonary disease (COPD);~        -  Lower mortality;~        -  An improved quality of life as compared to a group of placebo treated patients.~   "
261035|NCT00132847|"~     The purpose of this study is to test and compare the allergenic effects of three commercially~     available German cockroach allergen extracts in adults.~      Study hypothesis: The biological potency of three commercially available German cockroach~     allergy extracts can be compared using the ID50EAL method to standardize German cockroach~     allergens.~   "
261036|NCT00132834|"~     Current methods of measuring asthma severity can be problematic when used with children. A~     measurement called exhaled breath condensates (EBC) may be a more useful way to determine~     asthma severity in childhood. The purpose of this study is to determine if EBC measurements~     are useful for determining asthma severity in asthmatic children as compared to currently~     used laboratory measures.~      Study hypotheses: 1) A broad panel of EBC measures will distinguish asthmatic children not on~     inhaled corticosteroids (ICS) from both asthmatic children routinely taking ICS and~     nonasthmatic controls. 2) Standardized equipment and methodologies for EBC collection,~     processing, storage, shipping, and pH and mediator measurements can be developed that will~     eliminate significant contamination from oropharyngeal saliva and allow for shipping and~     processing at a central site.~   "
261037|NCT00132821|"~     Smoking is a major health problem with a direct link to elevated heart- and lung-related~     problems. Nicotine is highly addictive, which makes quitting difficult and relapse after~     quitting highly probable. Any type of sleep disturbance may make quitting even harder. The~     purpose of this study is to evaluate the effect of bupropion and nicotine replacement~     therapies (NRT) on sleep disturbances. In turn, this might show how such medications affect~     attempts at smoking cessation.~   "
261038|NCT00132808|"~     Osteoporosis prevention is important in patients with osteopenia (low bone density). This~     study will test the safety and efficacy of zoledronic acid in patients diagnosed with~     osteopenia.~   "
261039|NCT00132795|"~     The purpose of this study is to determine whether a telephone based self-help program will~     prevent relapse among individuals undergoing standard substance abuse treatment.~   "
261040|NCT00132782|"~     The purpose of this cross-sectional study was to determine the interrelationships between~     health status and measures of cardiac performance in children 6 to 18 years of age with~     congenital heart disease who have undergone a Fontan procedure as surgical treatment for~     functional single ventricle. The goal was to develop a data set that will permit~     identification of a clinically relevant endpoint for subsequent trials of medical management~     of the Fontan patient.~   "
261041|NCT00132769|"~     This study will look at whether this new drug is effective in the treatment of rheumatoid~     arthritis, and at whether it is safe and well-tolerated by participants with the disease.~   "
261045|NCT00132717|"~     The purpose of this study is to investigate the effect of an investigational~     cholesterol-lowering drug in patients who are currently taking an approved medication for~     hypercholesterolemia (high cholesterol levels) and have been hospitalized for a heart~     problem.~   "
261046|NCT00132704|"~     Doctors will take some tissue from the tissue removed during surgery in order to study how~     the blood vessels of the tumor respond to radiation therapy. The tissue obtained will be used~     to determine how these tumor blood vessels respond to radiation therapy delivered to the~     tumor, after it has been removed. This radiation is delivered in the research lab. This~     research is being conducted in order to develop new methods to treat tumors by radiation~     therapy. No additional surgery will be performed to obtain these samples, and only materials~     that remain after all diagnostic testing has been completed will be used.~   "
261047|NCT00132691|"~     The purpose of this study is to compare the effectiveness of standardized systemic therapy~     versus fluocinolone acetonide implant therapy for the treatment of severe cases of~     non-infectious intermediate uveitis, posterior uveitis, or panuveitis.~   "
261048|NCT00132678|"~     The purpose of this study is to determine if risperidone is effective and safe in the~     prevention of mood episodes in patients with bipolar 1 disorder.~   "
261049|NCT00132665|"~     The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in~     longer survival than radiotherapy alone in elderly patients with unresectable stage III~     NSCLC.~   "
261050|NCT00132652|"~     This study is being conducted to compare the safety and effectiveness of switching treatment~     from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from~     patients who were taking lamivudine and then switched to telbivudine will be compared with~     the results from patients who continued on lamivudine alone.~   "
261051|NCT00132639|"~     The purpose of this study is to evaluate the safety and efficacy of the preoperative~     docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal~     preoperative therapy for phase III trials.~   "
261052|NCT00132626|"~     This study assesses dopamine transporter density using single photon emission computed~     tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in~     research participants with Parkinson's disease.~   "
261053|NCT00132613|"~     The purpose of this study is to evaluate the efficacy of pericardial instillation of~     bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated~     malignant pericardial effusion.~   "
261054|NCT00132600|"~     The purpose of this study is to establish a concentration of a bacitracin-patch for~     diagnosing allergic contact dermatitis.~   "
261055|NCT00132587|"~     The aim of the study is to analyse and to compare the quality of fixation of a femoral~     implant with or without cement.~      One hundred thirty patients will be operated on and included with 2 groups, the first one~     with TKA all cemented and the second one with TKA with a cementless femoral implant. The~     study criteria include the IKS (International Knee Society) score and the analysis of a~     radiolucent line at the femur.~      Patients will be reviewed at 2, 6 and 12 months.~   "
261056|NCT00132574|"~     The purpose of this study is to determine whether minimizing the intake of milk and dairy~     products will reduce the recurrence of acne among people who have been successfully treated~     for acne with isotretinoin.~   "
261057|NCT00132561|"~     In countries of the Sahel and sub-Sahel, malaria transmission is highly seasonal with nearly~     all infections occurring during a few months of the year. However, mortality and morbidity~     from malaria may be high during this period, especially in young children who are the group~     most at risk.~      Intermittent preventative treatment (IPT) is a new approach to the prevention of malaria in~     this situation. IPT involves the administration of an anti-malarial to children at risk for~     malaria at fixed times, even if they are not infected. To investigate how effective this~     approach might be in Senegal, a trial has been undertaken in which 1136 children aged 6 weeks~     to 59 months were given a single dose of sulfadoxine pyrimethamine and artesunate on three~     occasions during a three-month rainy season and the incidence of clinical malaria in these~     children was compared with that in a group of children who received placebo. Additional~     observations were made on the incidence of side effects in children in the two groups and on~     the impact of IPT in children (IPTc) on markers of drug resistance in children whose blood~     films were positive for Plasmodium falciparum.~   "
261058|NCT00132548|"~     A recent study has shown that the administration of a single dose of~     sulfadoxine/pyrimethamine plus artesunate to Senegalese children on three occasions during a~     short malaria transmission season reduced the incidence of clinical attacks of malaria by~     86%. However, use of this drug regimen led to the selection of parasites with molecular~     markers of resistance to pyrimethamine and sulfadoxine. Therefore, a trial of three~     alternative regimens has been undertaken to see if these are as effective and safe as the~     drug combination used in the initial study but less likely to select for drug resistance.~   "
261059|NCT00132535|"~     There is conflicting evidence regarding the influence of HIV infection on the success of~     malaria prevention in pregnancy and effect on pregnancy outcome. The purpose of the proposed~     study is to assess the impact of HIV infection on the effectiveness of malaria prevention~     during pregnancy. This will be carried out by comparing two intermittent preventive~     treatments (IPTs) with sulfadoxine/pyrimethamine (SP) plus 300 mg weekly chloroquine with two~     doses IPT plus a weekly chloroquine placebo. The emphasis will be on assessing the effect of~     chloroquine on HIV viral load and malaria morbidity and foetal outcome.~      The study will be a randomised double-blind placebo-controlled trial with two arms, involving~     pregnant women attending antenatal classes (ANCs) at health units, enrolled early in their~     second trimester at 3 health units of the Mbarara district and Kampala. All pregnant women~     presenting for antenatal care, irrespective of parity, who consent to participate will be~     enrolled. Women with severe systemic disease or symptoms of AIDS will be excluded from the~     study data analysis.~      Women will be screened for HIV status and their HIV viral loads will be measured at~     enrolment. Parasitaemia will be assessed at enrolment; at the beginning of the third~     trimester; and at delivery. Haemoglobin will be measured at the same time points.~      The main outcome variables to be assessed will be maternal peripheral parasitaemia; placental~     parasitaemia; maternal clinical malaria; congenital parasitaemia; and maternal and neonatal~     haemoglobin, birth weight and viral load at enrolment and before nevirapine administration to~     the HIV positive mothers at birth.~      Anthropological pre-studies to assess the quality of ANC services and healthcare seeking~     practices of pregnant women in the study area will be carried out. Focus group discussions~     (FGD) with pregnant women and mothers of neonates; in-depth interviews with relevant health~     workers; and illness narratives from pregnant women will be used to collect data. The~     anthropological study results will assist in appropriately planning for the trial to enhance~     compliance to the intervention.~      The data collection is planned to commence in August 2003 and is expected to end in October~     2005. Twelve months will be spent on the write-up phase.~   "
261060|NCT00132522|"~     This study is looking at the safety and tolerability of the experimental biological drug EMD~     273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive~     ovarian, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental~     biological drug that may increase the immune response to certain cancers. Patients will be~     enrolled in groups of 3, with each successive group receiving a higher dose if the prior~     group adequately tolerates the study medication.~   "
261061|NCT00132509|"~     Data from the literature have suggested that a longer time of thrombolysis might be more~     effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed~     a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours.~      Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60~     minutes in the arm with a classical dose and 90 minutes in the arm with a low dose-longer~     infusion.~      This is a study of the outcome at 90 days.~   "
261062|NCT00132496|"~     The primary objective of this study is to collect safety information on rabeprazole 10 mg and~     20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16~     years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement~     of the symptoms of GERD and to explore the relationship of symptom relief to dose received,~     based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.~   "
261063|NCT00132483|"~     Summary~      This study will look at physical exercise after acute ischaemic stroke. It is called the~     ExStroke Pilot Trial.~      Physical activity is associated with a lower risk of first-time stroke. It remains unknown if~     physical activity also is associated with a lower risk of recurrent stroke. Patients with~     ischaemic stroke have a 30% to 40% risk of a recurrent stroke during a 5 year follow-up. The~     risk of acute myocardial infarction (MI) and death from vascular disease is approximately 15%~     each. The impact of lifestyle factors on risk for these events is insufficiently covered in~     the international scientific literature.~      Purpose:~      The purpose of the trial is to examine whether the level of physical activity increases in~     patients who have had an ischemic stroke, when they are informed about physical activity and~     instructed in a physical training program. The occurrence of new cerebro- and cardiovascular~     events in the patients will be registered. The patients are randomised to receive oral and~     written information by a physician and a physiotherapist about physical exercise; or to a~     control group with no instruction regarding physical exercise. Both groups will receive the~     best available therapy with regard to secondary stroke prevention and will be informed about~     lifestyle factors.~      Irrespective of which group the patients are randomised to, all patients will receive the~     best possible established treatment with regard to prevention of thromboses; blood pressure~     control; lipid lowering agents, if necessary; and information about diet, tobacco smoking,~     and vitamin supplements.~      Study Design:~      The patients will be randomised centrally within 90 days after stroke onset, and they will be~     re-examined at 3, 6, 9, 12, 18, and 24 months. Inclusion criteria are patients with ischaemic~     stroke, aged 40 years or older. In the pilot trial a number of 300 included patients is~     wanted.~   "
261064|NCT00132470|"~     The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa~     trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for~     acute ischemic stroke. The primary objective of the present phase IIa study is to assess the~     safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke.~     The secondary objective is to assess the effect of AX200 on subject outcome in comparison to~     placebo.~   "
261065|NCT00132457|"~     The purpose of this study is to determine if, among women who were treated for a prior~     chlamydial infection, home-based, self-collected vaginal swabs can increase rescreening for~     chlamydia in comparison with rescreening in the clinic. The study design is two randomized~     trials with enrollment at multiple family planning clinics and sexually transmitted disease~     (STD) clinics following a common protocol.~   "
261066|NCT00132444|"~     This study will help determine whether the agent UC-781, formulated as a gel, is safe when~     applied to the vagina twice daily for 14 days. It will also assess whether women find the gel~     acceptable to use.~   "
261067|NCT00132431|"~     The purpose of this research is to study the effects and safety of Sensipar approved by the~     Food and Drug Administration (FDA) in patients with kidney failure who are being treated with~     dialysis and have uncontrolled secondary hyperparathyroidism (HPT).~   "
261068|NCT00132418|"~     The objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid~     arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes~     mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis,~     sinusitis, or urinary tract infection) that might increase infection risk.~   "
261069|NCT00132405|"~     Minor needlestick procedures often cause significant pain and distress in children, yet~     interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use,~     prefilled, needle-free dispenser that immediately delivers powdered lidocaine into the~     epidermis and provides local analgesia in 2 to 3 minutes. The purpose of this prospective,~     randomized, double-blind, and placebo-controlled trial is to determine the efficacy and~     tolerability of ALGRX 3268 in children aged 3 to 18 years undergoing venipuncture. The trial~     will enroll a total of 306 children aged 3 to 18 years scheduled to undergo venipuncture of~     the back of the hand at a single study center.~   "
261070|NCT00132392|"~     ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of~     surgery for total replacement of the knee.~      Each subject will undergo a screening visit; a hospitalization, during which total~     replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after~     surgery. In addition, once discharged, subjects will be contacted by telephone daily up to~     Day 14. Subjects will complete pain and medication diaries during the first 2 weeks following~     surgery and will return these diaries at the 2 week visit.~      Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM)~     of the operated knee will be measured each morning at 8 AM ± 2 hours and each afternoon at 3~     PM ± 3 hours. In addition, if the subject ambulates, pain with ambulation will be measured~     during the first ambulation in the morning and during the first ambulation after noon.~     Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at~     the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive~     devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening,~     at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee,~     measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory~     mapping of the knee will be performed at screening and at the 12 week visit.~   "
261071|NCT00132379|"~     The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one~     that triggers an attack on the tumor cells by activating some white blood cells belonging to~     the body's normal immune system. In animals, this results in an accumulation of white blood~     cells in the cancer that can fight the cancer. This study will test how much of the drug, in~     combination with docetaxel (an approved drug for treating non-small cell lung cancer~     [NSCLC]), can be given to patients with NSCLC without causing unacceptable side effects.~   "
261072|NCT00132366|"~     This study will measure brain excitability in patients with succinic semialdehyde~     dehydrogenase (SSADH) deficiency, and in their parents. SSADH is a rare inherited disease in~     which changes in certain brain chemicals affect brain cell activity. Symptoms vary greatly~     among patients, and may include mental retardation, impaired ability to coordinate movements,~     and delays in language and speech development. Other symptoms may include poor muscle tone,~     uncontrolled seizures and other neurological or behavioral abnormalities. Test findings in~     patients and their parents will be compared with those of healthy normal volunteers.~      The following individuals may be eligible for this study: patients with SSADH who are between~     5 and 24 years of age; parents of patients who are between 18 and 55 years of age; healthy~     normal children who are between 10 and 17 years of age; and healthy normal adults who are~     between 18 and 55 years of age. Candidates are screened with blood and urine tests.~      All participants undergo the following:~        -  Transcranial magnetic stimulation (TMS): This procedure maps brain function. A wire coil~          is held on the scalp, and a brief electrical current is passed through the coil,~          creating a magnetic pulse that stimulates the brain. During the stimulation, the subject~          may be asked to tense certain muscles slightly or perform other simple actions to help~          position the coil properly. The stimulation may cause a twitch in muscles of the face,~          arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin~          under the coil. During the test, electrical activity of muscles is recorded with a~          computer or other recording device, using electrodes attached to the skin with tape.~        -  Magnetic resonance imaging (MRI): This test combines a powerful magnet with an advanced~          computer system and radio waves to produce accurate, detailed pictures of organs and~          tissues. During the scan, the subject lies on a table in a narrow cylinder containing a~          magnetic field, wearing ear plugs to muffle loud noises that occur with electrical~          switching of the magnetic fields. He or she can speak with a staff member via an~          intercom system at all times during the procedure. In addition to standard MRI, subjects~          may have newer MRI tests, such as diffusion tensor MRI and magnetic resonance~          spectroscopy.~      In addition to the above, patients and their parents may also undergo the following tests:~        -  Electroencephalography (EEG): This test records brain waves (electrical activity of the~          brain). Electrodes are placed on the scalp and brain electrical activity is recorded~          while the subject lies quietly, breathes deeply, watches flashes of light, or sleeps.~          Some patients may also have video-EEG monitoring, which involves simultaneous clinical~          recording using a video camera along with brain wave recording.~        -  Sleep study and multiple sleep latency onset testing (MSLT): Electrodes are placed on~          the subject's scalp and remain there while the subject sleeps in the hospital overnight.~          MSLT is done the next day, starting 2 hours after the subject wakes up from the night's~          sleep. A total of five 20- to 30-minute naps are recorded, each every 2 hours, to access~          daytime sleepiness.~        -  Nerve conduction studies: This test measures the speed with which nerves conduct~          electrical impulses and the strength of the connection between the nerve and the muscle.~          A probe is placed on the skin to deliver a small electrical stimulus, and wires taped on~          the skin record the impulses.~   "
261081|NCT00132249|"~     The Vietnam Head Injury Study (VHIS)-Phase III is a prospective, long-term follow-up study of~     head-injured Vietnam veterans. The purpose of this research study is to determine the~     long-term consequences, if any, of head injury.~   "
261073|NCT00132353|"~     This training protocol has two objectives: 1) to train NINDS fellows in specialized~     techniques for diagnosing neurological disorders, and 2) to gather data from healthy~     volunteers and from patients with various disorders needed for tests to diagnose disorders of~     nerve, muscle, and the areas of the brain controlling movement.~      Healthy volunteers and patients with neurological disorders of nerve and muscle who require~     specialized diagnostic testing may be eligible for this study. Candidates must be 18 years of~     age or older. They are screened with a medical history and neurological examination.~      Immediately after screening, participants undergo one or two of the following tests:~        -  Transcranial magnetic stimulation: This procedure maps brain function. A wire coil is~          held on the scalp, and a brief electrical current is passed through the coil, creating a~          magnetic pulse that stimulates the brain. During the stimulation, the subject may be~          asked to tense certain muscles slightly or perform other simple actions. The stimulation~          may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click~          and feel a pulling sensation on the skin under the coil. During the stimulation,~          electrical activity of muscles is recorded with a computer, using electrodes (small~          metal disks) attached to the skin with tape.~        -  Electromyography (EMG): This test measures the electrical activity of muscles and is~          used to diagnose problems with the nerves or muscles. For surface EMG, electrodes are~          filed with a conductive gel and taped to the skin. Needle EMG involves inserting a~          needle into a muscle to record the electrical activity. Single fiber EMG uses~          specialized needles that allow recording from single muscle fibers. The needle is~          inserted into a muscle and the subject is asked to tense that muscle slightly.~        -  Nerve conduction study: This test measures the speed with which nerves conduct~          electrical impulses and the strength of the connection between the nerve and the muscle.~          It is done by taping wires on the skin to record the impulses and placing a probe on the~          skin to deliver a small electrical stimulus.~        -  Near-nerve recording: This test is a nerve conduction study that is used to measure~          responses from very small nerves. It uses a needle placed under the skin to record the~          nerve response.~        -  Quantitative sensory testing: This test measures how well the subject feels vibration~          and cold. A probe that can vibrate or cool down is attached to the subject's finger or~          foot. The subject presses a button when he or she feels the stimulus. A computer adjusts~          the intensity of the stimulus to find the lowest level the subject can feel.~        -  Nerve ultrasound: This test uses sound waves to examine the nerves. Warm gel is applied~          to the skin and a probe is held on the skin surface.~   "
261074|NCT00132340|"~     This study will evaluate the effectiveness of deep brain stimulation (DBS) for treating~     primary dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting~     and repetitive movement or abnormal postures. Medical therapies are available, but not all~     patients get adequate relief from the abnormal movements or the pain associated with them.~     DBS is a surgical procedure that interrupts neuronal circuits in the globus pallidus interna~     (Gpi) and subthalamic nucleus (STN) - areas of the basal ganglia of the brain that do not~     work correctly in patients with dystonia. This results in decreased movement and therefore~     may lessen patients' symptoms and pain. The study will also examine the physiology of~     dystonia and determine whether the treatment effects of DBS in the Gpi differ significantly~     from DBS of the STN.~      Patients 18 years of age and older with primary cervical dystonia that does not respond to~     medical treatment or botulinum toxin (Botox) may be eligible for this study. Candidates are~     screened with blood and urine tests, chest x-ray, electrocardiogram, and magnetic resonance~     imaging (MRI, see below) of the brain.~      Each participant undergoes the following tests and procedures:~        -  Magnetic resonance imaging. This procedure is done after implantation of the stimulators~          to verify position of the electrodes. MRI uses a magnetic field and radio waves to~          produce images of the brain. The patient lies on a table that is moved into the scanner~          (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that~          occur during the scanning process. The procedure usually lasts about 45 to 90 minutes,~          during which the patient is asked to lie still for up to 15 minutes at a time.~        -  Transcranial magnetic stimulation. This procedure maps brain function. A wire coil is~          held on the scalp, and a brief electrical current is passed through the coil, creating a~          magnetic pulse that stimulates the brain. During the stimulation, the patient may be~          asked to tense certain muscles slightly or perform other simple actions. The stimulation~          may cause a twitch in muscles of the face, arm, or leg, and the patient may hear a click~          and feel a pulling sensation on the skin under the coil. During the stimulation,~          electrical activity of muscles is recorded with a computer, using electrodes attached to~          the skin with tape.~        -  Neurologic evaluation. Before and after DBS, the patient's dystonia is measured with a~          standardized rating scale called the Toronto Western Spasmodic Torticollis Scale~          (TWSTRS).~        -  DBS treatment. Patients are randomly assigned to have electrodes implanted in either the~          Gpi or STN area of the basal ganglia. The electrodes are what stimulate the brain in DBS~          therapy. Before surgery, a frame is secured to the patient's head, and an MRI scan is~          done. DBS involves making two small incisions and two small holes in the skull, opening~          the lining around the brain, locating the Gpi or STN, securing the electrodes in place,~          and connecting them to the pulse generator that is placed under the skin below the~          collar bone. In addition, during the surgery, the patient is asked to move certain~          muscles. The muscle activity is recorded to gain a better understanding of the~          physiology of movement. After surgery, MRI scans are done to confirm placement of the~          electrodes.~        -  Stimulation and evaluation. After surgery, patients' movements are evaluated during and~          after stimulation. The changes in movement and function are videotaped and scored~          according to a rating scale. The optimal stimulation settings are determined and the~          stimulators are adjusted accordingly.~      Neurologic evaluations with the TWSTRS scale are repeated at 1, 2, 3, 6 and 12 months after~     surgery, and the stimulators are adjusted as needed. Some of the evaluations are videotaped.~   "
261075|NCT00132327|"~     This study will analyze cells from erythema migrans lesions, the bull's eye rash of Lyme~     disease. Little is known about what happens in the skin when it is infected with Borrelia~     burgdorferi, the bacteria that cause Lyme disease. This study will examine and compare~     laboratory findings in skin biopsies from people with Lyme disease and from healthy normal~     volunteers to try to better understand the infection.~      Healthy volunteers and people with untreated erythema migrans rash who are 18 years of age or~     older may be eligible for this study.~      All participants undergo a clinical examination, blood tests, between two to four skin~     biopsies (removal of a small piece of tissue for laboratory examination), and complete two~     health questionnaires. The biopsies are taken from the erythema migrans lesion in patients~     with Lyme disease and from skin on the legs, forearms, buttocks, or side from healthy~     volunteers. To collect the tissue, the skin at the biopsy site is numbed with injection of a~     local anesthetic and a sharp instrument is then used to remove a round plug of skin about the~     size of a pencil eraser. The wound may be closed with one or two sutures, or allowed to heal~     without sutures. The sutures are removed after a week to 10 days.~      Patients with Lyme disease receive treatment for their condition. In addition, at the time~     the sutures are removed and at 4 weeks, 6 months, and 12 months after their first visit they~     fill out a questionnaire and have additional blood tests.~   "
261076|NCT00132314|"~     In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least~     one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly~     assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of~     oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but~     not specifying any particular oral agents or dosages). Recruitment would take 27 months to~     complete, and the study would continue for a third year to allow 9 months of follow-up for~     the last patient recruited. All patients would be treated from the time of entry up to the~     end of the three-year study period. Follow-up assessments would continue quarterly.~     Treatments would not be blinded since giving placebo injections to the comparison group would~     interfere with the goal of comparing the acceptability of two different methods of medication~     administration. However, end points will be blindly rated.~   "
261077|NCT00132301|"~     VA Cooperative Study #553 is designed to prospectively evaluate the efficacy of early~     adjuvant chemotherapy using docetaxel and prednisone added to the standard of care for~     patients who are potentially cured by radical prostatectomy but who are at high risk for~     relapse. The standard of care is surveillance, with the addition of androgen deprivation at~     the time of biochemical relapse. This study will assess the effect of adding early~     chemotherapy to the standard of care on progression free survival in Veterans at high risk~     for progression after prostatectomy.~   "
261078|NCT00132288|"~     This is a study of whether physical activity of older adults can be improved by linking~     primary care clinics serving older adults to a community-based program that provides~     motivational support, including peer counselors, for engaging in and maintaining moderate~     levels of physical activity.~      Health care providers at the participating study sites routinely assess and track diabetic~     patients' physical activity. In addition to this routine care, study volunteers are referred~     to a support program that has been modelled on the Active Choices Program. Changes in~     volunteers' levels of activity are measured at 3, 6, and 12 months.~   "
261079|NCT00132275|"~     Viral upper respiratory infections occur frequently during childhood (6-8 per year) and are,~     for the most part, self-limited episodes that resolve spontaneously and do not require~     antibiotic therapy. Acute otitis media and acute bacterial sinusitis are frequent~     complications of viral upper respiratory infections that will benefit from treatment with~     antibiotics. Acute bacterial sinusitis is one of the most common diagnoses in ambulatory~     practice and, in all age groups, accounts for an estimated 25 million physician office visits~     annually. It is essential to distinguish between patients who are experiencing uncomplicated~     viral upper respiratory infections and acute bacterial sinusitis to avoid the excessive use~     of antibiotics for patients who will not benefit from them. This is especially important now~     because of the escalation of antibiotic resistance among the bacteria that commonly cause~     acute bacterial sinusitis, acute otitis media and pneumonia. Inappropriate use of antibiotics~     is a major contributor to the problem of antimicrobial resistance - a problem which~     dramatically increases both the cost and complexity of treatment.~      To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce~     the inappropriate use of antibiotics, clinical guidelines have been developed by three~     national organizations: the American Academy of Pediatrics, the Sinus and Allergy Health~     Partnership and the Centers for Disease Control and Prevention. Traditionally, the diagnosis~     of acute bacterial sinusitis is suspected on the basis of clinical signs and symptoms and is~     confirmed with the performance of images (either plain radiographs, computed tomography or~     magnetic resonance imaging). All three guidelines recommend that the diagnosis and treatment~     of acute bacterial sinusitis should be based on clinical criteria alone without the~     confirmation of imaging or other laboratory data. Although the similarity between the~     different guidelines suggests that there is widespread consensus to use clinical criteria to~     diagnose acute bacterial sinusitis, there is virtually no evidence to support this position.~     Specific Aim 1 of this project is to evaluate the use of clinical criteria, without the~     performance of images, as the basis for the diagnosis of acute bacterial sinusitis. A~     randomized, placebo-controlled study design will be used to determine if the clinical~     criteria proposed by the different guidelines can be used to identify children with upper~     respiratory symptoms who will respond to antibiotic therapy. It is expected that children~     with acute bacterial sinusitis who receive an antimicrobial will recover more quickly and~     more often than children who receive placebo.~   "
261080|NCT00132262|"~     The purpose of this study is to evaluate the effectiveness and ethnic differences of a brief~     alcohol intervention for injured patients.~   "
264646|NCT00088140|"~     The purpose of this study is to determine if IDN-6556, when given orally, is safe and~     effective in patients with chronic hepatitis C virus infection.~   "
261082|NCT00132236|"~     This is a smoking cessation study with COPD patients where the researchers wanted to evaluate~     if nicotine sublingual tablets or placebo combined with low or high individual support could~     increase ½ and 1 year quit rates.~   "
261083|NCT00132223|"~     Angiographies of the supra-aortic vessels by magnetic imaging have become common recently. So~     it was the purpose of this study to evaluate the imaging potential of different contrast~     agents.~      Three contrast agents for magnetic resonance imaging are compared in angiographies of the~     supra-aortic arteries in a intraindividual study of 10 patients.~      All applications of these contrast agents are performed with a flow of 2 ml/s. One contrast~     medium is applicated a second time with a reduced flow of 1 ml/s.~      The angiographies of the supra-aortic vessels are evaluated by two experienced readers in a~     consensus reading. The signal/noise- and contrast/noise-ratio of anatomic vessel segments of~     the carotic and vertebral arteries are measured and compared to each other.~   "
261084|NCT00132210|"~     The purpose of this study is to determine whether pegylated interferon therapy is effective~     to treat acute hepatitis C infection in HIV-coinfected individuals.~   "
261085|NCT00132197|"~     The purpose of this study is to determine the effect of specialized treatment (including~     cognitive therapy, social counselling and a recommendation letter to the patients' primary~     care physician) on the functional level, emotional problems, and use of health care in~     patients with chronic medically unexplained symptoms.~   "
261086|NCT00132184|"~     The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's~     disease.~   "
261087|NCT00132171|"~     Eradication rates of Helicobacter pylori (H. pylori) with standard triple therapy are~     disappointing, and studies from several countries confirm this poor performance. The study~     aimed to assess the eradication rate of a new sequential treatment regimen compared with~     conventional triple therapy for the eradication of H. pylori infection.~   "
261088|NCT00132158|"~     The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in~     combination with ZD1839, that can be given safely to children and to learn the good and bad~     effects. Studies performed in the laboratory have shown that ZD1839 helps make available the~     orally administered irinotecan. In this study the intravenous (given into the vein) formula~     of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a~     fixed dose and will be administered orally on days 1-12. Each course of treatment will~     consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of~     course 2 will be an intravenous administration. All other doses and subsequent courses will~     consist of an orally administered dose.~   "
261089|NCT00132145|"~     Vascular diseases (cardiac events, strokes, peripheral vascular disease) remain the number~     one killer in Canadian society as well as the leading cause of hospitalization and days spent~     in the hospital. A 1996 estimate placed Ontario's vascular disease financial burden at $5.5~     billion in total. Any intervention which lowers vascular risk, will have a direct impact on~     the quantity and quality of life and costs of health care. Further integration of health~     professionals in teams focused on chronic disease management in individuals and populations~     is also ripe for further evaluation. Increased collaboration between family physicians,~     physician specialists, nurse practitioners, and pharmacists are generally thought to be~     beneficial for patient outcomes, but the literature is inconclusive and their~     cost-effectiveness is unproven. In addition, combining centralized electronic up-to-date~     information on the patient's status with evidence-based recommendations and the ability to~     communicate either electronically or by phone is expected to result in improved access to~     care, quality of care, continuity of care and increase cost-effectiveness of chronic disease~     management.~      COMPETE III builds on the researchers' previous work to study an electronic vascular tracking~     and decision support system shared by patients and their physicians, combined with a clinical~     care coordinator and automated telephone support system. The researchers are evaluating its~     impact on vascular risk processes and outcomes, perceived usefulness, ease of use, need for~     improvement, medication adherence, quality of life and patient goals and motivation.~      Study hypothesis: Patients at increased risk of vascular events, if connected with their~     family physicians, medical specialists and care coordinator via an electronic network (Web,~     fax and telephone) sharing an intensive tracking, advice and support program, will lower~     their vascular risk more than those in usual care.~   "
261090|NCT00132132|"~     This study will evaluate the impact a behavioral intervention can have on BMI. The~     researchers anticipate the intervention group will experience a decrease in BMI of~     approximately five points. The intervention group will be compared to a control group. This~     is a long term, randomized, controlled study. The behavioral intervention is conducted during~     a four hour monthly session. The behavioral intervention includes: exercise, education on~     medical aspects and nutrition, and empowerment.~   "
261091|NCT00132119|"~     The purpose of this study is to determine if nalmefene is safe and effective in the treatment~     of pathological gambling.~   "
261092|NCT00132106|"~     The activity of the sympathetic nervous system seems to influence the uptake (and handling)~     of glucose by the skeletal muscle of the forearm. Conditions in which sympathetic activity is~     increased seem to inhibit/reduce forearm glucose uptake. Inversely a decrease in sympathetic~     activity seems to increase glucose uptake. This study analyzes the effect of alfa-adrenergic~     receptor blockade (counteracting sympathetic influence) on insulin-stimulated forearm glucose~     uptake in patients with increased sympathetic activity (patients with chronic heart failure).~   "
261093|NCT00132093|"~     The purpose of this study is to ascertain whether treatment with the drug eplerenone, taken~     early after a heart attack, prevents or reduces some of the adverse changes that may~     otherwise naturally occur within the heart muscle, that lead ultimately to weakening of the~     heart muscle and premature death.~   "
261094|NCT00132080|"~     The primary endpoint is coronary artery diameter, normalized for body surface area, 5 weeks~     after randomization. Secondary endpoints include duration of fever, CRP levels, and adverse~     events.~   "
261095|NCT00132067|"~     This phase II trial is studying how well vorinostat works in treating patients with recurrent~     or persistent ovarian epithelial or primary peritoneal cavity cancer. Drugs used in~     chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Vorinostat may also stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
261096|NCT00132054|"~     RATIONALE: Drugs used in chemotherapy, such as amrubicin and irinotecan, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of amrubicin when~     given together with irinotecan in treating patients with recurrent or relapsed extensive~     stage small cell lung cancer.~   "
261142|NCT00131443|"~     The objective of this study is to assess the effectiveness and safety of topiramate in the~     prevention of basilar and hemiplegic migraine in children and adolescents.~   "
261097|NCT00132041|"~     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor~     cells. CT-, MRI-, or ultrasound-guided radiofrequency ablation may be an effective treatment~     for liver cancer and cirrhosis.~      PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating~     patients with liver cancer and cirrhosis.~   "
261098|NCT00132028|"~     This phase II trial is studying how well vorinostat works in treating patients with relapsed~     or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth.~   "
261099|NCT00132015|"~     RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin~     (17-AAG), work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with~     systemic mastocytosis.~   "
261100|NCT00132002|"~     This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating~     patients with progressive stage IV breast cancer. Drugs used in chemotherapy, such as~     suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic~     acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth~   "
261101|NCT00131989|"~     This phase I trial is studying the side effects and best dose of sorafenib in treating~     patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or~     chronic myelogenous leukemia. Sorafenib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth and by blocking blood flow to the cancer~   "
261102|NCT00131963|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. Giving chemotherapy after surgery may kill any tumor cells that remain~     after surgery.~      PURPOSE: This phase II trial is studying how well doxorubicin, cyclophosphamide, and/or~     paclitaxel work in treating women with nonmetastatic breast cancer.~   "
261103|NCT00131950|"~     RATIONALE: Lifestyle factors, such as physical activity, diet, and obesity, and hormone~     function may affect breast density. Screening tests, such as mammography, may help doctors~     find tumor cells early and plan better treatment for breast cancer.~      PURPOSE: This clinical trial is studying the effect of lifestyle factors and hormone function~     on breast density in healthy Hispanic women who are undergoing mammography for breast cancer~     screening.~   "
261104|NCT00131937|"~     This phase II trial is studying how well sorafenib works in treating patients with recurrent~     diffuse large B-cell non-Hodgkin's lymphoma. Sorafenib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
261105|NCT00131924|"~     RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that~     no longer respond to hormone therapy.~      PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in~     treating postmenopausal women with metastatic breast cancer that has failed previous hormone~     therapy.~   "
261106|NCT00131911|"~     This phase II trial is studying how well sorafenib tosylate works in treating patients with~     progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to~     the tumor.~   "
261107|NCT00131898|"~     This is a phase III clinical trial for patients with potentially completely resectable~     primary retroperitoneal sarcoma. Patients who take part will be divided into two groups, a~     radiation therapy plus surgery group and a surgery alone group.~      Patients in the radiation therapy plus surgery group will receive radiation treatments as an~     outpatient. Surgery to try to remove the remaining tumor will be done after the radiation~     treatments are completed.~      Patients in the surgery alone group will have surgery to try to remove all tumor.~   "
261108|NCT00131885|"~     This study will determine the effects of St. John's wort, a common herbal remedy, on~     metabolism of the female contraceptive hormone levonorgestrel.~   "
261109|NCT00131872|"~     The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE~     grafts for effectiveness in maintaining primary or assisted primary patency.~   "
261110|NCT00131859|"~     The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants~     diagnosed with cerebral white matter injury during the neonatal period and identify antenatal~     risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial~     gas results that are associated with cerebral white matter injury. The researchers'~     hypothesis is that this new imaging technique will help us better understand how these~     devastating injuries occur.~   "
261111|NCT00131846|"~     The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic~     adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose~     diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is~     metabolically safe when used with other appropriate antihypertensives, effective in reduction~     of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an~     equivalence trial.~   "
261112|NCT00131833|"~     This study is part of International Vaccine Institute (IVI)'s typhoid Vi demonstration~     project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic~     countries. The purpose of this study is to determine the effectiveness of the Vi vaccine~     following a mass typhoid immunization campaign in an endemic area in Hechi City in the~     Guangxhi province of China. The cost-effectiveness and safety of Vi vaccination will also be~     evaluated.~   "
261113|NCT00131820|"~     This study is part of International Vaccine Institutes (IVI)'s typhoid Vi demonstration~     project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic~     countries. The primary objectives of the study are to evaluate the logistic feasibility of a~     mass typhoid fever immunization campaign program targeting school age children in Hue City,~     Vietnam and to assess the knowledge, attitudes, beliefs, and practices of parents and~     healthcare providers in Hue City regarding typhoid fever prevention and treatment.~   "
261114|NCT00131807|"~     The purpose of this study is to explore the association between blood pressure, HIV and/or~     its treatment in a cross sectional observational study.~   "
261115|NCT00131794|"~     BCG vaccine is given at or shortly after birth in many developing countries to prevent~     tuberculosis. In Guinea Bissau, it has been shown that its protective effect against death is~     greater than would be expected from its effect against tuberculosis. This observation~     suggests that BCG may enhance the ability of the immune system of young children to make a~     protective response to other infections, including malaria. There is some evidence to support~     this hypothesis as BCG protects against malaria in experimental animals.~      Because BCG is a recommended vaccine, a randomised controlled trial of BCG at birth would not~     be ethically justifiable. However, it is not known whether re-vaccination with BCG in the~     second year of life might provide some added benefit and a large study to determine this is~     under way in Guinea Bissau. This study examined the effect of re-vaccination with BCG on the~     incidence of clinical malaria. If re-vaccination with BCG at 19 months of age is found to~     protect against malaria this would support the hypothesis that one of the ways that BCG at~     birth provides protection to young children is through an effect on malaria.~   "
261116|NCT00131781|"~     This is a randomised trial comparing cognitive therapy and supportive therapy administered~     along one year in borderline personality disorder. The follow-up is one year after treatments~     end.~      The therapists were the same in the two groups. Patients received one session a week during~     six months and one session every two weeks during the next six months~   "
261117|NCT00131768|"~     This clinical study is to evaluate the safety and efficacy of Synvisc in patients with~     symptomatic ankle osteoarthritis (OA). Patients will be given Synvisc, with the possible~     administration of a second injection where insufficient symptomatic pain relief was~     experienced during the initial 3 months follow up period.~   "
261118|NCT00131755|"~     The purpose of this study is to find out if Diazoxide can partly retain insulin production in~     newly diagnosed type 1 diabetes patients.~   "
261119|NCT00131742|"~     This study is being conducted to compare the effectiveness and safety of telbivudine (LdT)~     and lamivudine in Chinese adults.~   "
261120|NCT00131729|"~     The purpose of this study was to determine whether compliance with occlusion therapy for~     amblyopia could be improved and, secondly, if risk factors for non-compliance could be~     identified.~   "
261121|NCT00131716|"~     Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10%~     of such children die. In endemic countries, anaemia has multiple causes such as nutritional~     deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is~     believed to be the major contributory factor to the aetiology of severe anaemia. Severe~     anaemia is usually treated by blood transfusion although transfusion carries the attendant~     risk of transmission of HIV and other blood-borne infections. Thus, there is a need to~     explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such~     as children with suboptimal haemoglobin levels because these children are at increased risk~     of developing severe anaemia if they develop a malaria infection before their haemoglobin~     level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis~     with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect~     Gambian children from developing severe anaemia. After receiving treatment from the hospital,~     1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to~     receive either monthly S/P or placebo during the rest of the malaria transmission season.~     Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of~     the dry season to document morbidity and mortality.~   "
261122|NCT00131703|"~     Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in~     the primigravidae. Implementation of appropriate control and preventive measures is~     challenged by the fact that malaria infection in pregnancy is often asymptomatic and~     parasitized red blood cells sequestrated in the placental microcirculation may not be~     detectable in the peripheral blood. In addition, the widespread prevalence of parasites~     resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about~     newer antimalarials, poverty and inadequate supply have made antimalarial treatment options~     available to pregnant women very limited. These have necessitated an urgent search for~     alternative safe and efficacious treatment options for pregnant women. The objective of this~     study is to assess the efficacy, safety and tolerability of four antimalarial treatment~     options in rural Ghana within a programme setting.~   "
261123|NCT00131690|"~     The purpose of this study is to determine whether caffeine has any effect on birth weight.~   "
261124|NCT00131677|"~     The purpose of this study is to examine safety and tolerability of daily tenofovir use in~     HIV-uninfected men.~   "
261125|NCT00131664|"~     The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes~     Association guidelines glucose control, based on the A1C measurement, needs to be achieved~     within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The~     guidelines on the use of antihyperglycemic agents identify the potential benefits of~     sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic~     control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral~     antihyperglycemic monotherapy who then start on combination therapy may not achieve the~     required target glycemic control. Indeed early initiation of combination therapies may be~     necessary to achieve and maintain glycemic targets because of the progressive deterioration~     of pancreatic β cell function and glycemic control.~   "
261126|NCT00131651|"~     The purpose of this study is to determine an active dose of ATN-161 for future studies while~     establishing preliminary evidence of effectiveness in patients with renal cell cancer.~   "
261127|NCT00131638|"~     The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant~     human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis~     in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent~     chemotherapy as adjuvant treatment for their disease.~   "
261128|NCT00131625|"~     Exclusive breastfeeding is promoted by the World Health Organization (WHO) with the aim of~     improving infant health. The specific objective of the study was to examine the effect of~     exclusive breast-feeding on morbidity and mortality in a randomised prospective study.~     Children born by mothers recorded as living in the study area during pregnancy was randomised~     at birth. WHO recommendations to postpone introduction of water and weaning food were told to~     the mother by 2-weekly home visits. All study children were followed from birth till 1 year~     of age according to morbidity, hospitalisation and mortality.~   "
261129|NCT00131612|"~     For many years scientists and cancer researchers have been trying to find out why some people~     benefit more from anti-cancer medications than other people who receive the same amount and~     same kind of medications. Current studies suggest that inherited characteristics might~     explain these differences. Height and eye color are examples of characteristics that have~     been inherited from parents. Studies suggest that people might also inherit genetic~     differences in how their bodies break down medications. When a person receives an anti-cancer~     medication, it is broken down by the liver into smaller parts or by-products. To try to~     understand more about how people's bodies break down anti-cancer medications, the researchers~     are studying the by-products (called metabolites) of epirubicin in the blood of people who~     are taking this medication as part of their breast cancer treatment.~   "
261130|NCT00131599|"~     Cancer of the colon and rectum are the third most common cancers in Canadian males and~     females. The initial therapy of colorectal cancer is surgery to remove the cancer and nearby~     lymph glands. If the cancer has spread to the lymph glands there is a high chance that the~     cancer will come back. To reduce the risk of the cancer recurring, patients are treated with~     an anticancer drug 5-fluorouracil (5FU) in combination with a vitamin leucovorin (LV). This~     study will determine if a simple blood test can predict which patients are at risk for~     developing side effects from this chemotherapy. In addition, participants of this study will~     be followed to determine if this same blood test will predict which patients will have their~     cancer relapse.~   "
261131|NCT00131586|"~     Cisplatin is a widely used anti-tumor agent for the treatment of testicular and ovarian~     cancers. Carboplatin is used extensively for small cell, non small cell lung cancer and~     ovarian cancer. Oxaliplatin has recently been approved in the United States (US) for~     treatment of colorectal cancer. A large portion (in the range of 65% to 98%) of cisplatin in~     the blood plasma was bound to protein within a day after intravenous administration. The~     binding of cisplatin and other analogues to proteins and enzymes is generally believed to be~     the cause of several severe side effects such as ototoxicity and nephrotoxicity. The~     interactions between platinum based chemotherapy drugs and proteins is proposed to play~     important roles in both drug activity and toxicity. Therefore, a better understanding of the~     molecular mechanism of platinum-protein interactions may have an impact on optimization of~     strategies for treatment. The objective is to develop novel approaches and techniques to~     provide detailed mechanistic, kinetic and high-resolution structural information on the~     binding of platinum analogues to blood proteins, and to improve treatment efficacy and reduce~     side effects.~   "
261132|NCT00131573|"~     The goal of this study is to investigate the safety and effectiveness of a new implanted~     device designed to treat Urinary Urgency-Frequency Syndrome.~   "
261133|NCT00131560|"~     This study uses autologous (one's own) CD4 T cells modified with a viral vector expressing a~     genetic antisense targeting HIV, this vector is called VRX496. Study treatment is by~     intravenous infusion of vector modified cells and infusions will be provided every other week~     for a total of 4 or 8 doses. These modified cells, once infused, may provide immune support~     and are not destroyed by HIV, and thus may delay or reverse HIV disease progression. The~     study will enroll up to 40 male and female HIV-positive subjects in up to 8 centers. Subjects~     will be 18 years of age and over who have failed or are intolerant to at least one triple~     combination of antiretroviral drugs. Subjects must have a viral load between 5,000 and~     200,000 copies/ml and a CD4+ count of ≥150, be in good health and have no evidence of active~     opportunistic infection, heart disease, or bleeding disorders. Subjects must not be on~     corticosteroids, immunomodulating agents or hydroxyurea. Subjects must not have received an~     AIDS vaccine or any investigational gene therapy product at any time. Females must not be~     pregnant or breastfeeding.~   "
261134|NCT00131547|"~     The purpose of the study is to determine if weight loss interventions aimed at lifestyle~     modification (dietary education, food diary pedometer) result in weight loss in patients with~     mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The~     secondary purpose of the study is to determine if the amount of weight loss achieved in a 6~     month period results in improvements in snoring and other symptoms and in the frequency of~     apnea on overnight monitoring.~   "
261135|NCT00131534|"~     The overall purpose of this study is the assessment of treatment outcome among traumatized~     patients seeking individual and/or group therapy at the Victims of Violence Program. The~     study gathers information from patients using quantitative (self-report) and qualitative~     (interview-based) approaches, to determine changes in symptom patterns and domains of~     functioning relevant to psychological trauma.~   "
261136|NCT00131521|"~     This study compares N-acetylcysteine (mucomyst) and sodium chloride to determine their~     efficacy in the prevention of pulmonary mucus obstruction and retention in intubated patients~     admitted to the surgical trauma intensive care unit (STICU).~   "
261137|NCT00131508|"~     Children with sickle cell anemia (SCA) seem to have higher energy needs than children who do~     not have the disease. This may be the reason why children and teenagers with sickle cell~     anemia tend to be smaller, weigh less, and have less fat and muscle than children and teens~     that do not have the disease.~      This study is being done to find out if giving a supplement called glutamine will help~     children with sickle cell anemia by lowering their energy needs and improving their growth~     and strength. Children will be randomly assigned (like a flip of a coin) to one of two~     groups. One group will take glutamine and one group will take a placebo (a protein mixture~     that looks like glutamine but may not have the same effect in the body). No one will know~     which group is taking which supplement until the study has been completed. Children will be~     in the study for 12 months.~   "
261138|NCT00131495|"~     This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal~     testosterone patch in naturally or surgically menopausal women with low libido who are not~     receiving systemic estrogen or estrogen progestin therapy.~   "
261139|NCT00131482|"~     The purpose of this study is to evaluate the safety of Chrysalin, also known as TP508, and to~     determine the effectiveness of four doses of Chrysalin for treating broken wrists in adults.~   "
261140|NCT00131469|"~     The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which~     is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in~     adults affected with Osteogenesis Imperfecta (OI).~   "
261141|NCT00131456|"~     The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is~     effective in treating individuals with marijuana addiction and depression.~   "
261144|NCT00131417|"~     Severe malnutrition is a major cause of child morbidity and mortality in developing countries~     especially sub-Saharan Africa. The hospital mortality rate due to severe malnutrition in~     developing countries ranges from 20-30%. For the rehabilitation of severely malnourished~     children, the World Health Organization (WHO) recommends a liquid milk-based diet, Formula~     100 (F100), which contains 100 kilocalories per 100 milliliters. In Uganda, the~     rehabilitation of severely malnourished children is based on High Energy Milk (HEM), which is~     reconstituted cows milk with a nutritional composition similar to F100. Recently a semi-solid~     ready-to-use therapeutic food (RUTF) with similar composition as F100 or HEM has been~     designed. This preparation can be eaten without adding water hence reducing the risk of~     bacterial contamination. The preparation can be used at home with minimal supervision.~     Hitherto the efficacy of RUTF in the rehabilitation of severely malnourished children in~     Uganda has not been studied. The purpose of this study is to determine whether giving daily~     RUTF in the rehabilitation of severely malnourished children will result in a higher weight~     gain than giving HEM.~   "
261145|NCT00131404|"~     A study to determine the safety and efficacy of an investigational drug in patients with~     obesity plus extension.~   "
261146|NCT00131391|"~     A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an~     investigational drug.~   "
261147|NCT00131378|"~     This study will compare growth hormone levels and cardiovascular risk markers in normal~     weight and overweight women and men. In women and men with increased abdominal weight, growth~     hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin~     resistance and body composition will be measured.~   "
261148|NCT00131365|"~     The goal of this study is to develop additional long term data to evaluate the safety and~     effectiveness of this treatment.~      Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid~     tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a~     uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not~     seeking treatment for reasons of improving fertility.'~   "
261149|NCT00131352|"~     This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in~     patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F~     20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with~     Synvisc after the week 26 visit.~   "
261150|NCT00131339|"~     This study involves cognitive behavioral therapy (CBT) and a medication called D-cycloserine~     (DCS), which is thought to help reduce panic symptoms more effectively by interacting with~     N-methyl-D-aspartate (NMDA) glutamate receptors, facilitating many forms of learning~     including the extinction of fear. Participants will be randomly assigned (like flipping a~     coin) to receive either DCS or a placebo in addition to CBT.~   "
261151|NCT00131326|"~     This is a clinical study to investigate the safety and efficacy of Synvisc and Depo-Medrol in~     treating patients with osteoarthritis (OA) of the hip.~   "
261152|NCT00131313|"~     This research study measures the safety and efficacy of the combination of three drugs that~     are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia~     (CLL). These drugs are being given together for investigational purposes as the specific~     combination of these three drugs has not been approved for treatment of CLL by the FDA.~   "
261153|NCT00131300|"~     This clinical study is to evaluate the safety and efficacy of Synvisc in patients with~     symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible~     administration of a second injection where insufficient symptomatic pain relief was~     experienced during the 3 month follow up period.~   "
261154|NCT00131287|"~     The purpose of this study is to examine whether the extract of the Agaricus blazei Murill~     mushroom is effective in the supplementary treatment of type II DM patients.~   "
261155|NCT00131274|"~     The purpose of the study is to evaluate the safety and efficacy of Gleevec (imatinib~     mesylate) in the treatment of idiopathic pulmonary fibrosis (IPF).~   "
261156|NCT00131261|"~     The purpose of this open-label, non-randomized trial is to assess the safety and~     effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with~     advanced multiple myeloma. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor.~     Various members of this class of drugs have shown activity in preclinical studies and in~     initial clinical trials of multiple myeloma and lymphoma. Furthermore, HDAC inhibitors,~     including PXD101, have been shown to sensitize myeloma cells to the killing effect of other~     chemotherapeutic agents, including dexamethasone, a well-established agent in relapsing~     myeloma.~   "
261157|NCT00131248|"~     Study Question: In premature infants with apnea and/or bradycardia attributed to~     gastroesophageal reflux disease (GERD), does treatment with medications (acid blockers and~     motility agents), compared to placebo, reduce the frequency of apnea and bradycardia?~      Background: Many clinicians believe that apnea and bradycardia in preterm infants may be~     caused by gastroesophageal reflux (GER), however, studies have failed to demonstrate even a~     temporal association between episodes of GER and apnea. There have been no prospective~     randomized trials of treatment for GERD in preterm infants with apnea or other symptoms~     attributed to GER.~      Methods: A randomized, cross-over study will be performed. This cross-over design will~     provide the patient's clinician with unbiased information about the patient's response to~     treatment. The clinician can use this information in deciding whether or not to continue~     treatment after the two-week study period.~   "
261158|NCT00131235|"~     The purpose of this study is to examine whether treatment of pregnant Malawian women with~     repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm~     deliveries and result in other health benefits both for the mother and the foetus/newborn.~   "
261159|NCT00131222|"~     This study tests the hypothesis that underweight 6-17-month old infants receiving fortified~     spread as a food supplement for 12 weeks grow better during the supplementation than infants~     who are provided with maize-soy flour supplement.~   "
261160|NCT00131209|"~     This study tests the hypothesis that infants receiving fortified spread as a complementary~     food for one year grow better and do not become malnourished as often as infants who are~     provided with maize-soy flour for complementary porridge.~   "
261485|NCT00126880|"~     The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is~     in treating HIV-1 infected people who have failed treatment with lamivudine.~   "
261161|NCT00131196|"~     The proposal is aimed at identifying genetic factors that determine the incidence and~     severity of, and the outcome from life−threatening infections (severe sepsis/septic shock) in~     patients admitted to High Dependency Units (HDUs) or Intensive Care Units (ICUs) with~     pneumonia which developed outside the hospital (community acquired pneumonia − CAP) or~     contamination of the abdominal cavity with faeces due to a leak in the bowel (faecal~     peritonitis). This will require the acquisition of a large, high quality resource of genetic~     material (DNA), plasma, urine, white blood cells and clinical information from well~     characterized groups of similar patients with, or at risk for, severe sepsis/septic shock.~     The principal objective is to perform studies which are sufficiently large to establish~     beyond doubt the influence of a series of selected candidate genes on the development,~     progress and outcome of sepsis.~   "
261162|NCT00131183|"~     This study aims to address the following questions on the effects of testosterone therapy in~     men with coronary ischaemia:~        -  Does the anti-anginal effect persist long term? Many of the published studies are acute~          single dose trials and none of the chronic studies have assessed patients formally~          beyond a few months. The investigators' earlier studies were limited to 3 months.~        -  Does testosterone therapy in men affect the levels of measurable atheroma? There is~          currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of~          atheroma, although there is abundant evidence in animals to suggest a potential~          improvement.~      This study addresses the two issues and would be of one-year duration but would be the~     longest trial of testosterone therapy in men with cardiovascular disease. The primary~     endpoint is the change in time to ST- segment depression of > 1mm during exercise testing.~   "
261163|NCT00131170|"~     The effect of paravertebral block in combination with general anaesthesia is studied in a~     double blind fashion.~   "
261164|NCT00131157|"~     More and more general practitioners (GPs) use spirometry in their practices. At this time,~     there is sufficient reason to presume that, after a single postgraduate training program~     without any further support, most GPs have insufficient knowledge and ability to assure valid~     interpretation of their spirometry tests. Therefore, some kind of continuous diagnostic~     support with regard to spirometry interpretation by GPs is advisable. The aim of the present~     study is to assess whether implementation of spirometry expert support (either by a~     computerised expert system or a working agreement between general practitioners and~     respiratory consultants with respect to spirometry interpretation) causes changes in~     diagnosing and appropriateness and efficiency of medical care in subjects with chronic~     respiratory morbidity managed in general practice.~   "
261165|NCT00131144|"~     The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in~     approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening~     diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce~     the development and progression of diabetic retinopathy, intensive control of glucose is~     usually not achieved in clinical practice.~   "
261166|NCT00131131|"~     The specific objective of this project is to study the impact exercise has on gallstone~     formation during pregnancy when women are at increased risk due to biochemical and~     physiological alterations.~   "
261167|NCT00131118|"~     This is an extension study to examine the long-term safety and efficacy of zoledronic acid in~     patients who have completed the core CZOL446H2202 study.~   "
261168|NCT00131105|"~     The purpose of this study is to evaluate the effects of a 12-month telephone-supervised,~     home-based physical activity and dietary intervention, conducted in either a sequential or~     simultaneous fashion, on improving physical activity and dietary patterns in a high-stress~     population.~   "
261169|NCT00131092|"~     The purpose of the study is to compare a telephone-administered physical activity counseling~     program delivered by a person or by a telephone-linked computer system and test their~     relative benefits in improving regular physical activity among adults ages 55 and older.~   "
261170|NCT00131079|"~     The potential health gains from active lifestyles are very well-known and it is recommended~     that all adults dedicate at least 30 minutes to activities of at least moderate intensity at~     least five days a week. What is still not known is how to help sedentary people follow this~     recommendation, by means of brief interventions feasible in routine general practice. This~     multi-center study was designed to evaluate the effectiveness of a physical activity~     promotion program (called PEPAF) implemented in 56 general practices of the Spanish public~     primary health care system. The study will test the capacity of the program to increase the~     physical activity level, physical fitness and health related quality of life of sedentary~     people.~   "
261171|NCT00131066|"~     The purpose of this study is to evaluate the long-term safety and profile of psoriasis~     patients who have completed participation in a previous study and who received treatment with~     MEDI-507.~   "
261172|NCT00131053|"~     The purpose of this study is to investigate the efficacy and safety for treating adult ALL~     patients with the pediatric protocol.~   "
261173|NCT00131040|"~     The purpose of this study was to see if the heart-lung machine involved in cardiac surgery~     increases the movement of activated white blood cells from the bloodstream into the patient's~     tissues and also to see if aprotinin usage during surgery reduces this effect.~   "
261174|NCT00131027|"~     The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate~     consolidation therapy for adult patients with BCR-ABL-negative ALL.~   "
261175|NCT00131014|"~     The purpose of this study is to investigate possible genetic factors that contribute to the~     development of lymphomas. The databank will be used to determine whether familial lymphomas~     have unique genetic characteristics different from sporadic lymphomas and to attempt to~     identify a gene that confers an increased risk of lymphoma.~   "
261190|NCT00130819|"~     The purpose of this study is to compare the effectiveness of two approaches to treating~     HIV-infected patients who are addicted to opioid drugs (e.g., heroin) in an inner-city HIV~     clinic. The two approaches are:~        -  Case management and referral - participants are managed by a case manager and referred~          to a specialized drug treatment center where they receive counseling and medications for~          opioid-dependence (e.g., methadone or buprenorphine); or~        -  Clinic-based treatment - participants receive counseling and treatment with~          buprenorphine at the HIV clinic.~   "
266121|NCT00078728|"~     This study will evaluate the effectiveness of a short-term family-based program for~     preventing anxiety disorders in at-risk children.~   "
261176|NCT00131001|"~     PURPOSE: The purpose of this clinical trial is to study the cost-effectiveness ratios of~     diagnostic strategies for the imaging assessment of symptomatic carotid stenosis.~      MATERIALS AND METHODS: The diagnostic accuracies of Doppler ultrasound (DUS),~     contrast-enhanced magnetic resonance angiography (CEMRA) and computed tomography angiography~     (CTA) were compared with digital subtraction angiography (DSA) in a multicenter study~     (CARMEDAS; 206 patients assessable) and in a meta-analysis (for CEMRA and CTA). The direct~     costs of each imaging method were calculated in 2 university medical centers. Eight~     hypothetical models were studied with DUS considered as the first-line imaging method and~     either CEMRA or CTA or DSA as the second or third line method. The effectiveness criterion~     was the number of potential avoided strokes for each strategy and for 1000 patients.~   "
261177|NCT00130988|"~     General practitioners play a key role in the management of one of the most complex problems~     facing the health care system: the large group of patients with unexplained medical symptoms,~     but effective treatment strategies are lacking in primary care. The purpose of this study is~     to compare a new intervention delivered by the general practitioner versus re-attribution of~     symptoms, which is the currently recommended best treatment for patients with high levels of~     medically unexplained physical symptoms.~   "
261178|NCT00130975|"~     The purpose of this study is to test the hypothesis that treatment with the angiotensin II~     type 1 receptor antagonist candesartan may reduce the recurrence rate of atrial fibrillation~     after electrical cardioversion.~   "
261179|NCT00130962|"~     Subjects will have painful primary or post-operative intermetatarsal neuroma. Study drug or~     placebo will be injected into the space containing the neuroma. Subjects will complete weekly~     assessments for severity of foot pain, a brief pain inventory, and the amount of pain~     medication taken. Subjects will be seen for a screening visit, a treatment visit, and two~     follow-up visits after treatment. The last scheduled visit is one month after treatment. Some~     subjects may be followed by monthly telephone interviews to assess their level of pain over~     the six-month period following treatment.~   "
261180|NCT00130949|"~     Tennis elbow is a painful condition that results from repetitive arm movement with overuse of~     muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to~     reduce pain for a period of weeks to months. This study will test the efficacy and safety of~     ALGRX 4975 in the treatment of patients with tennis elbow.~   "
261181|NCT00130936|"~     Although declining in incidence, gastric/gastroesophageal cancer is still a commonly~     diagnosed malignancy in Canada. Patients who have undergone surgical resection for early~     disease have a high rate of local recurrence and distant spread. More than 50% of patients~     present with either locally advanced or metastatic disease. Patients with advanced disease~     have an extremely poor prognosis, with average survival times ranging from 3 - 9 months.~     Development of new therapeutic approaches for locally advanced or metastatic~     gastric/gastroesophageal cancer, is clearly needed.~      Despite its proven efficacy, ECF (epirubicin, cisplatin, and infusional 5-fluorouracil~     [5-FU]) has not been widely adopted in North America and is likely due to the technical~     difficulties and inconvenience associated with infusional chemotherapy. This study will~     substitute the oral chemotherapy drug capecitabine for infusional 5-FU in addition to~     substituting intravenous cisplatin with carboplatin (ECC - epirubicin, carboplatin and~     capecitabine). It is hoped that these substitutions will not only reduce the typical ECF~     related adverse effects but also allow for a more convenient administration of outpatient~     chemotherapy. It is also hoped that the genetic correlates of this study may also identify~     specific populations that preferentially benefit from ECC treatment.~   "
261182|NCT00130923|"~     The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to~     risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with~     schizophrenia or schizoaffective disorder.~   "
261183|NCT00130910|"~     Identifying methods to slow disease progression in patients with HIV-1 infection remains a~     top priority in many regions of the world. In many countries, medications known to slow~     progression are not readily affordable or available. Many of the individuals living in these~     countries are also co-infected with a variety of other diseases such as tuberculosis, malaria~     and soil-transmitted helminths. There are data to suggest that infection with these agents~     may activate the immune system in HIV-1 co-infected individuals and may lead to more rapid~     HIV disease progression. This study will evaluate the potential impact of treating helminths~     in HIV-1 seropositive individuals. Markers of disease progression and immune activation will~     be assessed. We will also measure the amount of virus in genital secretions to determine if~     treatment of co-infection can reduce the infectiousness of HIV in these individuals.~   "
261184|NCT00130897|"~     The primary objective of this protocol is to provide access to SU011248 treatment for~     patients with metastatic RCC who are ineligible for participation in ongoing SU011248~     clinical studies and have the potential to derive clinical benefit from treatment with~     SU011248 based on the judgment of the investigator.~   "
261185|NCT00130884|"~     The study will investigate the efficacy of oral levosimendan in patients with chronic New~     York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point~     evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at~     least 6 months.~   "
261186|NCT00130871|"~     The study evaluates the efficacy of intravenous levosimendan treatment started during a~     coronary artery bypass operation to wean patients from a heart lung machine.~   "
261187|NCT00130858|"~     Phase II Study to evaluate the response on two blocks of topotecan and carboplatin~   "
261188|NCT00130845|"~     The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in~     approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening~     diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce~     the development and progression of diabetic retinopathy, intensive control of glucose is~     usually not achieved in clinical practice.~   "
261189|NCT00130832|"~     The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to~     rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing~     the safety or immunogenicity of either vaccine.~   "
261191|NCT00130806|"~     This is a study to evaluate the effectiveness and tolerability of an investigational drug in~     patients with type 2 diabetes (a specific type of diabetes) who are not currently treated~     with insulin.~   "
261192|NCT00130793|"~     The purpose of this study is to determine whether the refrigerator-stable formulation of an~     investigational vaccine has a comparable immune response (the body's ability to protect~     against disease) and safety profile to that of the freezer-stable formulation of the vaccine.~   "
261193|NCT00130780|"~     This is a phase II, single institution trial for patients with clinical Stage IB-IIIA NSCLC~     (T1-3N0-2M0) who have resectable lung tumors. The primary goal of this study is to show that~     the addition of bevacizumab to a cisplatin-based chemotherapy in the neoadjuvant setting for~     non-squamous cell carcinomas improves the rate of pathologic downstaging, which correlates~     with survival. Downstaging is defined as any decrease in the final pathologic stage compared~     with the clinical stage before induction therapy.~   "
261194|NCT00130767|"~     The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a~     treatment of finasteride on benign prostate hyperplasia (BPH). Five sets of patients who need~     a surgical procedure because of low tract urinary symptoms are randomly attributed to one of~     five sets of treatment: 0, 7, 14, 21 or 28 days of finasteride treatment before the day of~     the procedure. Prostate histological fragments are conditioned for molecular and histologic~     studies.~   "
261195|NCT00130754|"~     Allogeneic stem cell transplantation is the treatment of choice for a growing number of~     malignant and non-malignant indications. Until recently, myeloablative in conjunction with~     immunosuppressive conditioning was considered mandatory for the elimination of malignant~     hematopoietic cells and to prevent graft rejection. The aim of allogeneic non-myeloablative~     stem cell transplantation (NST) is to induce host-to-graft tolerance with fast and durable~     engraftment of donor stem cells, by means of conditioning, which is well-tolerated by~     patients. The rationale behind the NST strategy is to induce optimal graft-versus-leukemia~     (GVL) effects for the elimination of all malignant cells by alloreactive immunocompetent~     cells from a matched donor as an alternative to standard high-dose myeloablative chemo~     radiotherapy. The NST protocol is therefore mainly based on immunosuppression and thus~     contains fludarabine, low dose busulfan and anti-T-lymphocyte globulin (ATG). Thymoglobuline~     is a polyclonal rabbit antiserum specific for human T cells used in organ transplantation for~     induction of tolerance and rejection prevention and treatment. It was also used in stem-cell~     transplantation (SCT) for the same purposes (e.g. for generation of tolerance and rejection~     preclusion) as well as a treatment for graft-versus-host disease (GVHD). Data from~     myeloablative protocols suggest that ATG before SCT significantly reduces the risk for grade~     III-IV acute GVHD. This does not translate to a reduction in transplant-related mortality~     (TRM) because of the increased risk for infections and thus survival is unchanged. Extensive~     chronic GVHD was also significantly shown to be reduced in patients receiving ATG in the~     myeloablative setting. However, the role of ATG in the NST protocol was never evaluated in a~     prospective randomized trial. In view of the preliminary data suggesting of an additive~     effect of ATG in these circumstances we, the investigators at Hadassah Medical Organization,~     evaluate the effect of ATG in NST by a prospective randomized trial.~   "
261196|NCT00130741|"~     This is an 8-week double-blind, placebo-controlled, randomized, parallel-group study with an~     additional two week baseline observation period to evaluate the safety of combination herbal~     therapy (CHT) versus placebo and short and long-term efficacy in terms of improved IBS,~     overall quality of life (QOL) and symptomatology.~   "
261197|NCT00130728|"~     This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study.~     Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.~   "
261198|NCT00130715|"~     The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence~     of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs)~     associated with the use of Seprafilm occurring within 30 days postoperatively, and the~     incidence of abdominopelvic abscess within 6 months postoperatively.~   "
261199|NCT00130702|"~     The purpose of this study is to determine how effective, and to what extent, Iressa is in the~     treatment of acute myelogenous leukemia.~   "
261200|NCT00130689|"~     Purpose: There remains a great need for novel therapeutic agents and treatment strategies for~     advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased~     EGFR expression in a significant proportion of both esophageal and gastric carcinomas.~     Inactivation of EGFR through use of a monoclonal antibody in preclinical models has resulted~     in inhibition of tumor growth. Agents designed to block the EGFR pathway have demonstrated~     disease control among previously treated patients with metastatic esophageal and gastric~     cancer. The proposed mechanism of action for cetuximab is its ability to effectively disrupt~     EGFR-mediated signal transduction pathways that ultimately leads to halting cell cycle~     progression, induces apoptosis, and also inhibits processes important for tumor growth, such~     as cell invasion and angiogenesis.~   "
261201|NCT00130676|"~     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called~     cortisol. Under normal conditions, cortisol and other hormones are created by the body in~     response to physical and emotional stress, triggering a healthy stress response. People who~     suffer from psychotic major depression may have unusually high levels of cortisol circulating~     within them or abnormal patterns of cortisol levels, overloading the stress response~     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If~     Corlux can keep the body's cortisol receptors from being overloaded, the stress response~     system may return to normal function, which may result in improvement of symptoms. The~     purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients~     who have been diagnosed with psychotic major depression (PMD).~   "
261202|NCT00130663|"~     This study will look at general pediatricians' effectiveness at screening children for~     elevated blood pressure values in the primary care setting. Two new screening tools will be~     introduced and their effectiveness will be measured against current practice by way of~     medical chart review.~   "
261203|NCT00130650|"~     The purpose of this study is to investigate the use of a new vapocoolant spray, Pain Ease, to~     reduce intravenous (IV) insertion pain in school-aged children receiving treatment in the~     Emergency Department.~   "
261213|NCT00130520|"~     The purpose of this project is to determine if a new combination of drugs, erlotinib~     (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian~     cancer whose cancer has progressed while on prior standard chemotherapy treatment with a~     taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).~   "
261228|NCT00130325|"~     There are new TB vaccines already developed that need to be tried in humans to assess their~     efficacy.~      The researchers had previously shown that production of interferon gamma by T cells in~     response to TB antigens is a more specific marker of TB infection.~      The researchers hypothesize that this can be used as a reliable early marker of TB vaccine~     efficacy. The researchers expect to show a significantly increased reversion of this test in~     household contacts of TB patients given Isoniazid prophylaxis treatment for 6 months.~   "
261229|NCT00130312|"~     The purpose of this study is to determine whether sulodexide is effective in slowing or~     preventing the progression of diabetic kidney disease.~   "
261204|NCT00130637|"~     This study will examine the safety and effectiveness of a monoclonal antibody called~     humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with~     uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis~     (JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and~     directed against a specific target in the body. The HAT antibody is designed to prevent a~     specific chemical interaction needed for immune cells to produce inflammation. Current~     treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not~     always work or they may cause significant side effects. This study will determine whether~     daclizumab can improve uveitis in children and reduce the need for other medicines.~      Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis~     requiring treatment with anti-inflammatory medications as often as three times a day or more~     may be eligible for this study.~      Each candidate is screened with a medical history, physical examination, blood tests, eye~     examination, and the following specialized tests:~        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected~          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina~          are taken using a camera that flashes a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating the presence of~          inflammation.~        -  Optical coherence tomography to measure retinal thickness. The eyes are examined through~          a machine that produces cross-sectional pictures of the retina. These measures are~          repeated during the study to determine changes, if any, in retinal thickening.~        -  Stereoscopic color fundus photography to examine the back of the eye. The pupils are~          dilated with eye drops to examine and photograph the back of the eye.~      Upon entering the study, participants receive a 90-minute infusion of daclizumab through a~     catheter (plastic tube) placed in an arm vein. They return to the clinic after 14 days and~     again after 28 days for repeat eye examinations, blood tests, and daclizumab infusions. Four~     weeks after the third infusion, patients are examined for response to treatment. Those who~     have benefited from daclizumab may continue receiving monthly infusions of the drug for up to~     one year. A blood test and eye examination are done at the time of each infusion. Patients~     whose disease has remained active 12 weeks after the first infusion are taken off the study~     and treated with other medications.~   "
261205|NCT00130624|"~     The study aims to determine whether multidisciplinary assessment of community-based patients,~     who have had at least one previous fall, reduces the rate of further falls and fall-related~     problems. The study also aims to determine whether such an intervention, if effective, is~     best carried out in a primary or secondary care setting.~   "
261206|NCT00130611|"~     Cost-effective management of heart failure and pulmonary disease is of paramount importance.~     Unfortunately, the rapid and accurate differentiation of heart failure from other causes of~     dyspnea in private practice is challenging. B-type natriuretic peptide (BNP) levels are~     significantly higher in patients with congestive heart failure as compared to patients with~     dyspnea due to other causes. As a simple, non-expensive assay easily applicable in private~     practice is available, rapid measurement of BNP might be very helpful in establishing or~     excluding the diagnosis of heart failure in patients presenting with acute dyspnea in private~     practice.~      The aim is to test the hypothesis that a BNP guided diagnostic strategy would improve the~     evaluation and management of patients presenting with acute dyspnea to physicians in private~     practice and thereby reduce total cost of diagnosis and treatment.~      The primary endpoint is total medical cost within 3 months.~   "
261207|NCT00130598|"~     Contrast nephropathy (CN) remains a common complication of radiographic procedures and an~     important cause of hospital-acquired acute renal failure. Only hydration with saline is~     uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN.~     But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even~     more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim~     of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with~     a prolonged infusion of sodium chloride in the prevention of CN.~      Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.~   "
261208|NCT00130585|"~     The main objectives of this project are:~        1. to determine the relative bioavailability of dietary folate from a total diet, compared~          with synthetic folic acid and~        2. to determine the bioavailability with a higher precision than previous methods.~      The hypothesis is that the bioavailability of dietary folate within a confidence interval of~     +/-20% can be estimated.~   "
261209|NCT00130572|"~     The purpose of this study is to investigate whether topical applied pimecrolimus will lead to~     improvement of erosive oral lichen planus. This effect will be monitored by reduction of~     erosive mucosal area and reduction of patient's pain symptoms.~   "
261210|NCT00130559|"~     Heart failure is a common reason for respiratory failure in ICU patients. The rapid and~     accurate differentiation of heart failure from other causes of respiratory failure remains a~     clinical challenge. BNP levels are significantly higher in patients with congestive heart~     failure as compared to patients with respiratory failure due to other causes. Therefore,~     rapid measurement of BNP might be very helpful in establishing or excluding the diagnosis of~     heart failure in patients with respiratory failure in the ICU.~      The aim is to test the hypothesis that a BNP guided diagnostic strategy would improve the~     evaluation and management of patients presenting with primary (on admission) or secondary~     (while in the ICU) respiratory failure in the ICU and thereby reduce total treatment time and~     total cost of treatment.~      Primary endpoints are time to discharge and total cost of treatment. Secondary endpoints are~     ICU length of stay, ICU cost, in-hospital mortality, 30-day mortality, cost-effectiveness, 6~     and 12 month mortality, 6 and 12 month dyspnea score.~   "
261211|NCT00130546|"~     The main objective of this study is to assess the safety and effectiveness of the Sirolimus~     eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native~     coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting~     with two or more coronary artery stenoses (prospective, randomized, intra-individual~     comparison).~   "
261212|NCT00130533|"~     This is a prospective, open-label, randomized phase III study. Patients will be stratified as~     per investigational site, previous adjuvant chemotherapy (anthracyclines versus~     anthracyclines plus taxanes), and number of affected axillary lymph nodes (0, 1-3, >= 4).~     Node negative patients must present a tumour size > 2 cm to be eligible. At least 6 lymph~     nodes must be analysed to confirm the number of affected nodes. Patients will be randomised~     to receive: 8 courses of capecitabine 1000 mg/m2 by mouth, twice a day (p.o. bid) for 14~     days, followed by a 7 day rest versus observation.~      Tissue samples must be analysed by a central laboratory, to confirm estrogen receptor (ER),~     progesterone receptor (PgR), human epidermal growth factor receptor-2 (HER2), cytokeratins CK~     5/6 and epidermal growth factor receptor (EGFR) status.~      The following data were obtained from the database of the El Alamo project. One thousand~     six hundred and twenty-seven (1,627) in total were considered during the years 1990 to 1997.~     The population is formed of patients with operable breast cancer, with surgery, positive~     nodes, and negative hormone receptors, or negative nodes, negative hormone receptors and T2-3~     tumors.~      For these patient groups, estimated 5-year disease-free survival is 64.72%. Assuming an~     exponential distribution, the aim is to detect an increase of 64.72% to 73.7% in 5 years~     Disease Free survival rate corresponds to a Hazard Ratio of 0.701 and a risk reduction of~     about 30%, with a power of 80% using a two-tailed log-rank test at 0.05 and whereas 4 years~     of recruitment period and 3 years of follow-up period. We would need 255 events, 834 patients~     without considering any dropouts.~      Considering a drop-out rate of 5% post-randomization, the final sample size will be 876~     patients, 438 per treatment arm.~      The sample size calculation was performed by the program package EAST version 5.2.~   "
261214|NCT00130507|"~     Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab,~     until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.~     HER2 status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are~     eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization~     (FISH).~      Principal outcome is clinical benefit (complete + partial responses + stable disease). Sample~     size in each arm has been estimated with the Fleming method. Previous data show a clinical~     benefit rate of vinorelbine plus capecitabine around 50%. The researchers assume trastuzumab~     can increase it by 20%. With an alpha error of 0.05 and 80% power, 37 patients per arm are~     needed.~      This is a randomised phase II trial. With a minimum expected benefit rate of 50%, at least 36~     patients are needed to choose, with a 90% of probability to be right, the best treatment arm,~     providing it increases benefit rate at least by 15%.~      Assuming a drop-out rate of 10%, the total number of patients needed is 82, 41 per treatment~     arm.~      Patients will be stratified as per investigational site, and presence of visceral metastatic~     lesion (liver, lung, pleura, heart, peritoneum, suprarenal glands). All patients must receive~     2 cycles. If no disease progression is detected, treatment must continue until progression or~     unbearable toxicity.~   "
261215|NCT00130494|"~     This is an open-label, randomized, multicenter phase III trial to assess the efficacy of~     early administration of zoledronate versus observation in delaying bone-related symptoms in~     metastatic breast cancer patients.~      Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation~     until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per~     treatment arm will be enrolled in the study.~      Once bone-related symptoms appear, study participation is over. During the study, the~     following will be assessed:~        -  quality of life,~        -  performance status,~        -  pain rating,~        -  analgesic administration and~        -  adverse events The principal objective is the delay in bone-related symptoms in those~          patients with early zoledronate administration.~   "
261216|NCT00130481|"~     The purpose of this study is to determine if Atorvastatin can improve blood vessel stiffness~     and blood vessel function in children 10-18 years old with Type 1 and Type 2 diabetes.~     Subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch~     therapies for the next 3 months.~      Hypothesis: Atorvastatin will improve blood vessel function by decreasing arterial stiffness~     and improving blood flow.~   "
261217|NCT00130468|"~     This study will evaluate the efficacy and safety of intra-articular injections of 20 mg/2mL~     dose HYALGAN in patients with pain due to osteoarthritis (OA) of the knee.~   "
261218|NCT00130455|"~     The study is designed to establish the efficacy and tolerability of escitalopram in the~     treatment of depressive episodes of mild to moderate severity in the elderly.~      The study is designed as a mainly naturalistic study including all patients of 65 years of~     age or above that judged by the clinician would benefit from treatment by an antidepressant~     medication. The study is designed as a double-blind, randomised placebo controlled study with~     two groups of active treatment (escitalopram in two doses, 5 or 10 mg daily) in a twelve week~     period.~   "
261219|NCT00130442|"~     The aim of the study is to compare the safety and effectiveness of a new drug called PI-88,~     when used in combination with an approved chemotherapy drug called dacarbazine, in the~     treatment of metastatic melanoma.~      PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine~     stops the cancer cells from growing. The results from this study will be analysed to see if~     it is worthwhile for the two drugs to be tested in future studies involving larger numbers of~     melanoma patients.~   "
261220|NCT00130429|"~     The purpose of this study is to assess the effect of PYM50028 administered once daily for up~     to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's~     disease.~   "
261221|NCT00130416|"~     The overall goal of this randomized, controlled trial is to test whether educational~     interventions - directed toward empowering patients and delivered via the Beth Israel~     Deaconess Medical Center (BIDMC's) secure patient Internet portal PatientSite - can improve~     the outcomes and satisfaction with care of adult primary care patients with 3 common~     conditions: chronic pain, depression, and progressive difficulty walking.~   "
261222|NCT00130403|"~     To determine how prior therapy with alendronate or risedronate in postmenopausal women with~     osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of~     the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change~     from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP),~     between subjects previously treated with risedronate and those previously treated with~     alendronate.~   "
261223|NCT00130390|"~     The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide~     compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's~     disease in adults.~   "
261224|NCT00130377|"~     This is the clinical registry of cell based therapies that is available to researchers around~     the world. The registry is web based. All researches must provide IRB approval to the~     coordinating site- University of Utah in order to obtain access to the registry. The are~     predetermined case report forms for cardiovascular diseases that are currently in clinical~     trials- including demographics, safety, and possible efficacy end-points. All investigators~     have access to their own data. The servers are U.S. HIPPA compliant and protected with secure~     back-up.~   "
261225|NCT00130364|"~     This study is not being conducted in the United States of America (USA).~      Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin~     elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell~     activation. These cells are involved in the inflammatory component of the disease. This study~     will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face~     in patients intolerant of, or dependent on, topical corticosteroids.~   "
261226|NCT00130351|"~     This study is designed to investigate the ability of patients with asthma to properly use a~     new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.~   "
261227|NCT00130338|"~     The goal of this research study is to evaluate, in the open-label extension phase, the~     effectiveness, tolerability and safety of rivastigmine capsules in males and females between~     the ages of 50 and 85 years old with probable vascular dementia.~   "
266122|NCT00078611|"~     The purpose of this trial is to evaluate natalizumab in individuals with moderately to~     severely active Crohn's Disease.~   "
261231|NCT00130286|"~     The purpose of the study is to determine if the combination of recombinant human growth~     hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than~     either drug alone (or no active therapy) for the treatment of fat accumulation in people with~     HIV infection and insulin resistance.~   "
261232|NCT00130273|"~     This study will determine whether a managed problem solving intervention can help patients~     with HIV better follow their anti-HIV drug regimen and can control HIV better than the~     standard of care.~   "
261233|NCT00130260|"~     This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus~     aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease~     patients, by giving a 3rd and 4th dose to a subset of the participants in the previous~     efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner,~     and are also randomly assigned to 1 of 2 different intervals between the doses. The~     immunogenicity is measured by the antibodies in the blood, and typical vaccine safety~     information is also collected.~   "
261234|NCT00130247|"~     Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the~     body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then~     take 2 of the same medicines for 4 more months, for a total of 6 months. The purpose of this~     study is to see if taking 4 months of TB medicines is as effective in curing some TB patients~     as taking 6 months of TB medicines. Study participants will include 758 human~     immunodeficiency virus (HIV)-non-infected individuals, ages 18-60. Participants will be~     treated with 4 standard drugs called isoniazid, rifampicin, pyrazinamide and ethambutol. All~     individuals will take TB medicines for at least 4 months. After 4 months of treatment, if no~     TB germs are growing in sputum samples, participants will be assigned to either stop taking~     TB medicine (4 months of treatment) or to continue taking TB drugs for 2 more months (6~     months of treatment). Participants will be involved in study procedures for up to 30 months.~   "
261235|NCT00130234|"~     This study is being done to find out if a drug called Xolair (omalizumab), an anti-IgE~     antibody, is safe and effective for people with chronic urticaria (hives) with persistent~     symptoms in spite of taking antihistamines.~   "
261236|NCT00130221|"~     Patients in the intensive care unit are at risk for many infections because the severity of~     illness and the procedures necessary to care for them. This study is designed to look at a~     change in bathing procedure as a method to reduce infections. Currently, patients at John H.~     Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous~     study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth~     (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen~     bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating,~     no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The~     goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic~     Cloth system compared with soap and water in cleansing the skin and preventing bacteria from~     entering the bloodstream.~   "
261237|NCT00130208|"~     The purpose of the study is to determine whether treatment with sulodexide is effective in~     reducing the level of urine albumin excretion in patients with early diabetic kidney disease~     expressed as microalbuminuria.~   "
261238|NCT00130195|"~     The purpose of this study is to determine the clinical efficacy and safety of~     imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.~   "
261239|NCT00130182|"~     The purpose of this study is to investigate the safety and effectiveness of two dose~     strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).~   "
261240|NCT00130169|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974~     administered on Days 1 and 15 of a 28-day cycle in subjects with solid malignancies that have~     progressed following effective therapy or for which no effective therapy exists.~   "
261241|NCT00130156|"~     The purpose of this study is to investigate the efficacy and safety of Bunazosin with~     Valsartin compared to Doxazosin with Valsartin for patients with mild to moderate essential~     hypertension accompanied by metabolic syndrome.~   "
261242|NCT00130143|"~     Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug~     approved to reduce the short and long-term occurrence of dry mouth when patients receive~     radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces~     the side effects of radiation treatment for lung cancer. The use of Amifostine is still being~     investigated in lung malignancies. Amifostine is found to be a protectant from radiation side~     effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and~     testes. Patients that receive radiation treatments for lung cancer may experience side~     effects involving the esophagus. It is hoped that patients will benefit from the protection~     of their esophagus and avoid delays in radiation treatment due to side effects of the~     radiation.~   "
261243|NCT00130130|"~     The overall purpose of this project is to improve nurse skills regarding neuropathic pain~     (NP) assessment, treatment and referral practices through implementation of an evidence-based~     algorithm and to improve selected patient outcomes as a result of algorithm use.~   "
261244|NCT00130117|"~     The purpose of this study is to determine whether administration of an investigational~     medication called leptin (r-metHuLeptin) in replacement doses can improve bone health,~     reproductive function, hormone levels, immune function, and overall sense of well-being in~     women with hypothalamic (exercise-induced) amenorrhea (HA) who are being treated with oral~     contraceptive pills (OCPs), compared to placebo. Women with hypothalamic amenorrhea have low~     leptin levels. This study is based on the hypothesis that the relative leptin deficiency in~     women with hypothalamic (exercise-induced) amenorrhea may be the reason for the lack of~     menstrual cycles, hormone abnormalities, and bone loss associated with this condition.~   "
261245|NCT00130104|"~     The purpose of this study is to determine if the transthecal metacarpal block is superior to~     the traditional digital block for regional digital anesthesia in children.~   "
261246|NCT00130091|"~     The current study will compare the effects on postoperative pain relief of freezing~     (ropivacaine 0.2 %) alone and in combination with clonidine for a nerve block in children~     undergoing hernia repair. The researchers anticipate that the addition of clonidine to~     freezing will result in prolongation of postoperative pain relief in children undergoing~     hernia repair compared to freezing used alone.~   "
261247|NCT00130078|"~     Heterosexual contact is now the primary route of transmission for HIV worldwide. This study~     is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G~     (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at~     high risk.~   "
261248|NCT00130065|"~     The purpose of this study is to determine whether folic acid, which is often routinely given~     to pregnant women to prevent birth defects and anemia, affects the efficacy of~     sulfadoxine-pyrimethamine, another drug that is routinely given to pregnant women in highly~     malarious areas, for prevention of the adverse effects of malaria during pregnancy.~   "
261249|NCT00130039|"~     This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1~     segment of Middle cerebral artery (MCA) or basilar artery).~      They will be randomly assigned into cilostazol group or clopidogrel group. Every patients~     will take 100mg of aspirin a day additionally.~      The primary outcome variable of this study is Progression rate of symptomatic intracranial~     stenosis on magnetic resonance angiogram (MRA).~   "
261250|NCT00130026|"~     The objective of this study is to determine if caffeine 500 mg intravenously is efficacious~     when added to standard anti-emetic prophylaxis in the prevention of post-operative nausea and~     vomiting (PONV) in patients undergoing ambulatory surgery under general anesthesia.~   "
261251|NCT00130013|"~     The World Health Organization’s (WHO) standard case management strategy for reducing acute~     respiratory infection (ARI) related mortality recommends oral cotrimoxazole and oral~     amoxicillin as first line drugs for the treatment of pneumonia. In 1989, the Pakistan~     Ministry of Health (MOH) adopted this strategy to control ARI mortality and recommended~     cotrimoxazole for treatment of outpatients pneumonia due to lower costs. A number of studies~     subsequently performed have shown significant in vivo and in vitro resistance of H.~     influenzae and S. pneumoniae, the commonest bacteria causing childhood pneumonia, to~     cotrimoxazole.~      Although on a case by case basis for pneumonia, in vitro resistance does not correlate very~     well with in vivo failures, nevertheless, clinical failure rate for pneumonia therapy has~     increased in Pakistan over the years. One can hypothesize that if bacterial pneumonia is a~     certain proportion of all pneumonia cases, the rise in clinical failures may be related to~     increasing antimicrobial resistance. Therefore, it is probable that this rising clinical~     failure rate could be a reflection of increasing resistance. There may be an increase in~     antimicrobial resistance of S. pneumoniae and H. influenzae to amoxicillin over the period of~     years and the rising treatment failure could be a reflection of the rising minimum inhibitory~     concentrations (MIC’s) (> 2 mcg/ml for H. influenzae, 1993-94), thereby, resulting in this~     increasing failure rate.~      For the current study the researchers propose a multicentre, randomized, controlled double~     blind trial in which standard versus double dose oral amoxicillin for three days for the~     treatment of non-severe pneumonia in children less than five years of age will be compared.~      Primary Objective:~      To compare the proportion of children 2 – 59 months of age presenting with non-severe~     pneumonia, who achieve clinical resolution on day 5 with standard (15 mg/kg/8hrly) versus~     double dose (30 mg/kg/8hrly) of oral amoxicillin therapy given for 3 days.~      Secondary Objective:~      To follow the clinical course of non-severe pneumonia with the alternative criteria of~     treatment failure (signs of deterioration i.e. lower chest indrawing and appearance of danger~     signs) on or before day 3 and compare them with other children who have persistent fast~     breathing (respiratory rate above the cut off for age) on day 3.~      Hypothesis:~      Therapy outcome with double dose of oral amoxicillin is not different than the standard dose~     of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2–59~     months old children.~   "
261252|NCT00130000|"~     This study will evaluate the safety and effectiveness of the experimental drug eculizumab for~     treating paroxysmal nocturnal hemoglobinuria (PNH), a disorder that can cause premature~     destruction of red blood cells. PNH may result in anemia requiring blood transfusions.~     Patients may be at high risk of life-threatening blood clots in their veins and may have~     urine discoloration, stomach pain, difficulty swallowing, tiredness, and poor quality of~     life. Men may have problems getting or maintaining an erection. Eculizumab is a monoclonal~     antibody that may improve the survival of red blood cells in patients with PNH.~      Patients 18 years of age and older who have been diagnosed with PNH for more than 6 months,~     who have active disease, and who require blood transfusions may be eligible for this study.~     Each candidate is screened with a physical examination, electrocardiogram, blood and urine~     tests, and a questionnaire for information on how PNH affects the patient physically,~     socially, emotionally, and functionally.~      Participants receive infusions of eculizumab through a needle in a vein once a week for five~     doses and then every two weeks for another 24 doses. All patients are vaccinated against~     Neisseria meningitides, a bacteria that can cause symptoms, possibly including~     life-threatening meningitis, in susceptible people, including people who take eculizumab.~      At every treatment visit, patients update their health status, transfusion record, and~     medication use; review their laboratory results from the preceding visit; have vital signs~     measured; and provide a blood sample for laboratory tests. At selected visits, they also~     provide a urine sample, have a repeat electrocardiogram, and complete a questionnaire. At the~     final treatment visit, participants have a complete physical examination, in addition to the~     routine procedures.~   "
261253|NCT00129987|"~     Long term conditions often necessitate long term care. In many cases, giving control of their~     conditions to the patients themselves produces the best outcomes. Such patient education and~     the acquisition of self-management skills can be time consuming and the evidence suggests~     that the process is often not undertaken by doctors. Sometimes it is delegated to nursing~     colleagues, but all health professionals are in short supply. Patients carry credibility as a~     resource and this project is designed to determine, by means of a multi-centre randomised~     controlled trial, whether well trained lay educators can deliver training in self-management~     education to others with asthma, with outcomes equivalent to those achievable by a nurse.~   "
261254|NCT00129974|"~     The purpose of the study is to determine whether pemetrexed and gemcitabine cause good tumour~     shrinkage when given to patients with previously untreated extensive-stage small cell lung~     cancer. The second purpose is to see if the side effects appear better than what is expected~     with standard chemotherapy.~   "
261255|NCT00129961|"~     The purpose of this study is to determine the effect of sirolimus on the prevention of new~     non-melanoma skin cancer (NMSC) in kidney transplant recipients.~   "
261256|NCT00129948|"~     This is a phase 2, single-arm, open-label, multi-center study to establish the safety and~     efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to~     subjects with AML.~   "
261257|NCT00129935|"~     This is a prospective, randomised phase III trial, to compare the efficacy and safety~     profiles of two types of adjuvant chemotherapy regimens for HER2 negative, node positive~     breast cancer patients.~      Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4~     cycles of T 100 mg/m2 day 1 every 3 weeks.~      Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by~     4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a~     one-week rest period.~      Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen~     after the end of chemotherapy.~      Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or~     aromatase inhibitors (or both) after the end of chemotherapy.~      Patients may receive radiotherapy when clinically indicated.~   "
261258|NCT00129922|"~     The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.~      Also, for axillary positive node patients, optimum chemotherapy regimens are still under~     discussion. Some previous studies suggest that, in the subset of node-positive patients,~     treatments based on sequential administration of anthracyclines and taxanes are more~     efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic~     index (activity/toxicity).~      The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of~     proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8~     weekly paclitaxel administrations (100mg/m2).~      The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The~     investigators expect to increase this by 8% with the experimental treatment. With an alpha~     error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250~     patients are needed, 625 per arm.~   "
261259|NCT00129909|"~     The objective of this study is to assess whether the implementation of a primary treatment~     algorithm using a fixed dose combination therapy will improve the management of hypertension~     when compared to usual management.~   "
261260|NCT00129896|"~     This is an open-label study to assess the efficacy and tolerability of the combination~     Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients.~     HER2 status will be confirmed centrally by fluorescence in situ hybridization (FISH).~      Phase I: Initial doses will be:~      Myocet: 50-60 mg/m² day 1 every 3 weeks; Taxotere 60-75 mg/m² day 1 every 3 weeks; and~     Herceptin (4) 2 mg/kg weekly.~      Sample size will depend on the number of patients recruited during dose escalation. Three~     patients must be recruited in each dose level. If one out of three experiences a~     dose-limiting toxicity (DLT), 3 more patients must be recruited in the same dose level.~     Considering that there are 4 dose levels to be tested, the estimated number of patients is 9~     to 24. Patients receiving the recommended dose (RD) will be incorporated into phase II of the~     study.~      Phase II: The average pathological complete response rate reported in other trials is around~     11%. The investigators expect to achieve an increase of 14% on this rate; that is, they~     expect a pathological response rate of 25%. With a= 0.05 and β=0.2, 18 patients are initially~     needed. If at least 3 pathological complete responses are achieved, recruitment will continue~     to up to 53 patients. At least 10 pathological complete responses are needed to probe the~     hypothesis. Considering a 10% post-randomization drop-out rate, a total of 59 patients must~     be recruited for the trial.~   "
261261|NCT00129883|"~     The purpose of this study is to test a strategy to improve the quality of antibiotic use in~     lower respiratory tract infections (LRTIs) at hospitals. Therefore, a multifaceted~     intervention strategy is compared to a control strategy and the effectiveness and feasibility~     of the intervention is assessed.~   "
261262|NCT00129870|"~     The primary rationale for this study is to develop an optimized schedule of administration of~     FOLFOX + bevacizumab that maximizes the efficacy and safety of this regimen when administered~     to patients with advanced colorectal cancer. The hypothesis is that the use of an~     intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow these patients to~     continue on treatment for a longer period of time by reducing the proportion of patients who~     discontinue therapy early because of treatment-related toxicities and thus increasing the~     possibility of a longer time to progression.~      The primary objective is:~        -  To test the hypothesis that an intermittent oxaliplatin (IO) schedule of~          FOLFOX/bevacizumab will allow patients to remain on therapy for a longer period of time~          compared to a conventional treat-to-failure schedule, by reducing the proportion of~          patients who discontinue therapy for treatment-related toxicities.~      The secondary objectives are:~        -  To evaluate the impact of calcium/magnesium infusions on the incidence and severity of~          neurotoxicity in subjects receiving either the IO or conventional FOLFOX/bevacizumab~          treatment schedules as first-line treatment for metastatic colorectal cancer.~        -  To evaluate the safety and efficacy of the IO versus the conventional schedule + calcium~          and magnesium infusions, as part of oxaliplatin-based first-line therapy for metastatic~          colorectal cancer.~   "
261263|NCT00129857|"~     Each year a large number of patients are hospitalized at Shock Trauma Centers with severe~     head injuries. Bleeding into and swelling of these patients' brains may cause compression of~     vital structures, disability and death. Sometimes surgery is needed. Unfortunately, the~     investigators have no medication to treat the bad effects of head trauma. Part of the brain~     damage is due to toxic chemicals (including one called glutamate) that are released by the~     damaged nerves. Dexanabinol may prevent some of the bad effects of glutamate on the brain and~     may protect the brain against uncontrollable swelling and death.~   "
261264|NCT00129844|"~     The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer~     (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.~   "
261265|NCT00129831|"~     The purpose of this study is to determine the safety and tolerability of single doses of~     QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to~     moderate COPD.~   "
261266|NCT00129818|"~     The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day~     (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with~     and without a reported history of genital herpes and with or without herpes virus type 1~     (HSV-1) seropositivity.~   "
261267|NCT00129805|"~     Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT)~     levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic~     peripheral arterial disease.~      S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of~     sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with~     recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint~     was recurrence of cerebral infarction; relative safety was also assessed.~   "
261268|NCT00129792|"~     This study will determine the effects of a supplement in reducing symptoms of metabolic~     syndrome, a collection of symptoms that increase the risk for developing heart disease,~     stroke, and diabetes.~   "
261320|NCT00129116|"~     This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine~     and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed~     meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age.~     Antibody persistence and immune responses to booster vaccinations were additionally assessed~     at 12 to 18 months of age.~   "
261269|NCT00129779|"~     Chronic obstructive pulmonary disease (COPD) is a term used for the conditions of chronic~     bronchitis and emphysema, diseases that are very common among the elderly and diseases that~     account for up to15% of all general medical admissions to National Health Service Hospitals.~     In a recent report on emergency admissions to acute hospitals in London, the King's Fund~     concluded that taking better care of elderly patients with COPD could reduce pressures on~     acute hospitals, and suggested that identification of vulnerable patients with lung disease~     and pro-active, rather than reactive, management might reduce the chances of~     hospitalisation. In this study, the investigators wish to compare a group of patients with~     COPD who are managed in the normal way, with another group of patients with COPD who receive~     all interventions known to be of some benefit to those with this condition. This will include~     a pulmonary rehabilitation programme, intensive education regarding self care, targeted~     advice to their general practitioners regarding how best to manage COPD, and regular contact~     with specialist respiratory nurses who will support the patients in their own homes by a~     combination of home visits and telephone contact. The value of such a comprehensive~     intervention will be studied, in terms of both its ability to reduce admissions to the~     hospital and its impact on quality of life.~   "
261270|NCT00129766|"~     The primary objective of this study was to compare the safety and efficacy of motavizumab to~     palivizumab when administered monthly by intramuscular (IM) injection for the reduction of~     the incidence of RSV hospitalization among children at high risk for serious RSV disease. A~     secondary objective was to compare the incidence of medically-attended lower respiratory~     infections (LRIs) between treatment groups.~   "
261271|NCT00129753|"~     Primary Objective:~      To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed~     and resistant classical Hodgkin's lymphoma.~      Secondary Objectives:~        1. To determine the duration of response and time to progression after Campath-1H therapy~          in this patient population.~        2. To determine the effect of Campath-1H on serum IL-6, IL-10, and IL-13 levels in patients~          with relapsed and resistant classical Hodgkin's lymphoma.~   "
261272|NCT00129740|"~     The goal of this clinical research study is to learn if an experimental agent, AMN107~     (nilotinib), can help to control CML in chronic phase. The safety of this experimental agent~     will also be studied.~   "
261273|NCT00129727|"~     Study Design: This ia a Phase II study.~      Subjects: Patients with chemotherapy naive epithelial ovarian cancer; or fallopian, primary~     peritoneal and papillary serous mullerian tumors will be recruited.~      Carboplatin and Taxol (paclitaxel) will be administered concurrently with bevacizumab after~     surgery for 6-8 cycles every 21 (q21) days. Bevacizumab will be omitted in the first cycle,~     immediately post-operatively. This will be followed by one year of bevacizumab q21.~      Outcomes: Outcomes include toxicity, response rate, and progression free survival.~   "
261274|NCT00129714|"~     The Westeinde Brachialgia Study (WEB) is a randomized controlled trial to establish the~     effect of cervical collar or physiotherapy compared to a wait-and-see policy in patients with~     acute cervical radiculopathy.~   "
261275|NCT00129701|"~     Consultation time in busy respiratory clinics is inevitably limited and attendance is often~     disruptive to patients' lives; involves time, expense, travel, and waiting; and can have~     effects upon occupation. Published work suggests that patient satisfaction with telephone~     consultations is high and this subject has recently been extensively reviewed by one of the~     study investigators. In respiratory medicine there is United States (US) data to suggest that~     the regular telephoning of adolescents with asthma by a specialist nurse can reduce~     unscheduled use of health service resources. In the United Kingdom (UK), a randomised,~     controlled trial in primary care has shown that, compared to face to face consultations, use~     of the telephone can enable greater numbers of patients with asthma to be reviewed. Another~     of the study investigators has undertaken a feasibility study in a general respiratory clinic~     and has shown the concept of alternating face to face consultation with telephone~     consultation to be acceptable to over 80% of patients. Over one third were assessed to be~     suitable in that they did not need to attend the clinic for either physical examination or~     for investigations. It is therefore proposed to evaluate the feasibility, acceptability, time~     savings and safety of the use of telephone consultation in 3 respiratory clinics in the~     Department of Respiratory Medicine at Charing Cross Hospital.~   "
261276|NCT00129688|"~     Once-daily dose administration of aminoglycoside in adults is effective and economical.~     However, its value in febrile neutropenic children, especially in Thailand, is less well~     researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic~     children is low, the combination of cloxacillin and amikacin is an appropriate approach. This~     study would like to compare the efficacy and safety including cost between these two amikacin~     administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical~     therapy in febrile neutropenic children.~      Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic~     children in Khon Kaen, Thailand.~   "
261277|NCT00129675|"~     The overall goal of this study is to evaluate the use of dopamine transporter (DAT) imaging~     as a diagnostic tool in subjects with early parkinsonian symptoms, in whom Parkinson's~     disease (PD) or parkinsonian syndrome (PS) is suspected, but the diagnosis remains unclear~     from a clinical standpoint.~   "
261278|NCT00129662|"~     Some five million people in the United Kingdom (U.K.) have asthma. The British Guidelines on~     Asthma recommend self management education and the issuing of written personal asthma action~     plans. The use of such self management education has been shown to be associated with an up~     to 40% reduction in hospitalisation rates and a 20% reduction in Emergency Department~     attendances and similar benefits in terms of symptoms and time off work. In asthma, the~     results are best when the patients are provided with a personalised written action plan~     explaining how to alter their medications according to a variety of circumstances. Chronic~     obstructive pulmonary disease is a major cause of hospitalisation in the U.K. and is the~     fourth biggest single cause of death. A recent Cochrane review regarding the value of self~     management education in COPD has led to equivocal results although it has shown that those~     with COPD are willing to take control of their own conditions. The reasons for the different~     outcomes in asthma and COPD may reflect an inadequate number of trials of the wrong type;~     interventions that were not appropriate or do not work; lack of the use of written action~     plans; or assessment of benefit using the wrong outcomes.~      Given the importance attached to the written action plan, it is essential that such advice is~     available to all. However, studies of outpatients attending hospitals in the U.K. have shown~     that 15% may be functionally illiterate and in studies of adults with asthma in the United~     States (U.S.), 13% have similarly shown to be functionally illiterate. Pictorial advice may~     therefore be advantageous and, when tested amongst those who are literate, it has been also~     shown to enhance the recall of spoken medical instructions. The investigators have therefore~     prepared some pictorial representations which are designed to give advice to those with~     asthma and COPD about how to recognise the worsening of their conditions and what treatments~     to alter or initiate as a result. The investigators now need to assess the comprehensibility~     of those materials amongst a selection of patients with asthma and COPD.~   "
261279|NCT00129649|"~     Many studies have shown a high non-attendance rate in hospital outpatient clinics. The~     investigators have found a non-attendance rate of 25% in their asthma clinics and would like~     to investigate whether a reminder phone call will improve attendance rates. Patients will be~     randomised into two groups; one group will receive a reminder phone call one week prior to~     their hospital consultation and the other group will be managed in the standard manner (i.e.~     no reminder of any sort). The phone calls will be carried out on a Friday afternoon by a~     respiratory nurse specialist and a research officer for two asthma clinics based on a~     Wednesday morning and a Thursday afternoon.~   "
261280|NCT00129636|"~     As part of the NHS plan it has been proposed to extend some consultants' usual practices and~     to send all patients copies of the letters sent to their general practitioners (GPs)~     following outpatient consultations. The current Secretary of State for Health has further~     extended this proposal and suggested that patients should have a specific letter to~     themselves after a hospital consultation.~      The aim of this study is to send patients both a copy of the letter sent to their GPs and a~     specific letter to themselves and to assess the usefulness and comprehensibility of each.~   "
261281|NCT00129623|"~     This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly~     compared with placebo in post-menopausal women with osteopenia. Patients will be randomized~     to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study~     treatment is 1-2 years, and the target sample size is 100-500 individuals.~   "
261282|NCT00129610|"~     The study aims at comparing virtual reality therapy (VRT) with a usual cognitive behavior~     therapy (CBT) program for agoraphobia. A waiting list represents the control condition. The~     investigators' purpose is to test a pure VRT compared with a pure CBT, as previous works~     suggest that the combination of the two methods are clinically effective. Patients receive a~     two-page information leaflet about the trial and sign an informed consent. After the first~     evaluation, they are randomized, in three centers (Lyon, Paris, Luxemburg), either to VRT (12~     sessions) or CBT (12 sessions), or a waiting-list control condition for three months. After~     three months the waiting list is randomized to VRT or CBT. The follow-up is one year from~     entry into the active part of the trial.~   "
261283|NCT00129597|"~     Prevalence of chronic pain after mastectomy is beyond 50% 3 months after surgery. This pain~     is related to a sensitization of the central nervous system through N-methyl-D-asparate~     (NMDA) receptors. Ketalar might prevent the occurrence of chronic pain by anti-NMDA~     properties after mastectomy.~   "
261284|NCT00129584|"~     The purpose of this study is to assess the safety and efficacy of the Emphasys Endobronchial~     Valve (EBV) and procedure (with pulmonary rehabilitation) compared to optimal medical~     management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.~   "
261285|NCT00129571|"~     The purpose of this study is to assess the safety and tolerability of XL820 when given orally~     to adults with advanced solid tumors.~   "
261286|NCT00129558|"~     This Phase I/II, multi-centered, non-randomized, trial is designed to determine a safe dose~     of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as~     therapy in subjects with refractory leukemia.~   "
261287|NCT00129545|"~     This is a multi-center, prospective, randomized study, stratified by center, comparing the~     WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is~     non-inferior to the control arm. This study was amended to allow for a non-randomized arm and~     increased enrollment.~   "
261288|NCT00129532|"~     Heterosexual contact is now the primary route of transmission for HIV worldwide. This study~     is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G~     (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at~     high risk.~   "
261289|NCT00129519|"~     The primary objective of this study is to assess whether basal cell carcinoma (BCC) lesions~     surgically treated with curettage, followed by imiquimod 5% cream as postsurgical adjuvant~     therapy, will have an improved cure rate over the ED/C historical norm of approximately 70%~     at 1-year posttreatment follow-up. A secondary objective is to assess cosmetic outcome.~   "
261290|NCT00129506|"~     Background: In most countries in which abortion is legal, medical abortions are induced with~     mifepristone and misoprostol. Since mifepristone is expensive and unavailable in many~     countries, it is important to find other regimens. Methotrexate, which is used with~     misoprostol in Canada, is also difficult to obtain in many countries. Misoprostol is~     inexpensive and available in almost all countries. A report from Nigeria found that 98% of~     100 women aborted within 24 hours of using misoprostol given both sublingually and vaginally.~      Method: This will be a randomized controlled trial of the usual regimen used in Canada,~     methotrexate 50 mg/m2 intramuscularly (IM) followed three days later by 800 mcg vaginal~     misoprostol to the Nigerian regimen of 400 mcg sublingual misoprostol with 400 mcg vaginal~     misoprostol. The main outcome measure will be a completed abortion within the first week with~     secondary outcome measures including total surgery rate, time to abortion, complications,~     pain, side effects and patient satisfaction.~      Rationale: If the investigators can find an inexpensive, easily available, method of medical~     abortion, it will save many lives in third world countries.~   "
261291|NCT00129493|"~     This study investigates group medical visits as a quality improvement strategy for~     hypertension. It studies group visits in which patients see their own primary care provider~     together with other patients who have hypertension. The group visits are intended to enhance~     the patient's self-efficacy for self-management of their chronic disease (hypertension).~   "
261292|NCT00129480|"~     The primary objective of this study is to determine to what extent a collaborative~     intervention improves chronic pain-related outcomes in a VA primary care setting. We will~     also determine to what extent the intervention affects 1) treatment of co-occurring~     depression, 2) adherence of providers to guidelines for treating chronic pain, and 3) patient~     and provider satisfaction and attitudes related to chronic pain treatment.~   "
261293|NCT00129467|"~     The purpose of this study is to determine whether methylphenidate is an effective treatment~     for depression and to document the safety and tolerability of methylphenidate in combination~     with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill,~     hospice and palliative care cancer patients. The investigators hypothesize that depressed~     hospice and palliative care patients will be more likely to have a 50% reduction in scores on~     a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared~     to those patients who are taking a placebo plus an SSRI.~   "
261294|NCT00129454|"~     Effective treatments have been developed to ameliorate symptom-related distress and reduce~     unnecessary healthcare utilization using cognitive-behavioral techniques (CBT) . However~     there is a major limitation of this treatment is that patients must attend sessions in~     person. The specific aims of the study are to: (1) Determine the clinical efficacy of~     Telephone CBT for veterans with GWI who are frequent consumers of ambulatory medical care;~     (2) Determine whether CBT for veterans with GWI leads to a reduction in the cost of VA health~     care; and (3) Develop a statistical model of treatment seeking in veterans with GWI who are~     frequent consumers of ambulatory medical care.~   "
261295|NCT00129441|"~     The purpose of this research study is to determine whether a short-term administration of an~     investigational study drug may provide evidence of improvement in cognitive functioning in a~     group of stable male subjects with schizophrenia.~   "
261296|NCT00129428|"~     This research study will evaluate the effectiveness of high dose UVB light therapy in the~     treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn~     scars, granuloma annulare or related conditions.~   "
261297|NCT00129415|"~     The purpose of this investigation is to study the effectiveness of longer wavelength UVA1~     (340-400nm) or shorter wavelength ultraviolet B [UVB] (290-320nm) irradiation in the~     treatment of inflammatory skin conditions (such as: atopic dermatitis, psoriasis, mycosis~     fungoides, alopecia areata, stretch marks and urticaria).~      This research study aims to evaluate the effectiveness of an investigational device which is~     similar in appearance to a tanning bed but which emits ultraviolet irradiation of a~     specific wavelength known as UVA1. This device has not been approved by the Food and Drug~     Administration (FDA) for general use in this country, as of yet, but it has been used quite~     successfully in Europe for several years in treating such conditions as scleroderma, atopic~     dermatitis, urticaria pigmentosa and other skin conditions.~      Instead of UVA1 therapy, patients may receive ultraviolet radiation of a specific wavelength~     known as UVB. UVA1 light is a longer wavelength and therefore a lower energy wavelength than~     UVB. UVB light is often the light associated with getting a sunburn since it has a higher~     level of energy. UVB light has been used successfully in the treatment of many skin~     conditions.~   "
261298|NCT00129402|"~     This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to~     evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages~     10-17 years with Heterozygous Familial Hypercholesterolemia.~   "
261299|NCT00129389|"~     This is a prospective, open-label, randomized, phase III trial. Patients will be stratified~     after breast surgery, as per investigational site; menopausal status; node negative~     diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status~     (positive versus negative). Patients will be randomized to:~        -  FAC x 6 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2 + cyclophosphamide 500~          mg/m2 day 1, every 3 weeks, for 6 cycles.~        -  FAC x 4 (cycles) → Taxol® x 8 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2~          + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 4 cycles, followed by 8~          administrations of weekly paclitaxel 100 mg/m2~      Premenopausal women with hormone receptor positive tumors must receive tamoxifen 20 mg daily~     for 5 years, after the end of chemotherapy.~      Postmenopausal women with hormone receptor positive tumors are allowed to receive aromatase~     inhibitors as initial adjuvant hormone therapy or after tamoxifen.~      All patients with breast conservative surgery must receive radiotherapy.~      Estimated 5-year disease-free survival in the control arm (FAC x 6) is expected to be 80%. It~     is expected that disease-free survival will increase by 5% in the experimental arm~     (FAC-paclitaxel). 906 patients per arm must be recruited, to detect this difference with an~     alpha error of 0.05 and 80% power. Assuming a 6% post-randomization drop-out rate, 960~     patients per arm are needed, 1920 in total.~   "
261300|NCT00129376|"~     Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions).~      The pathological complete response rate obtained in previous studies is around 12%. The~     expected pathological complete response rate in this study is 25%. With an alpha error of~     0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed~     initially. With 2 pathological complete responses, patient recruitment will continue until~     approximately 61 patients are recruited. Twelve pathological complete responses are needed to~     confirm the study hypothesis.~   "
261301|NCT00129363|"~     The objective of this study is to evaluate the long-term safety of carvedilol in pediatric~     patients with chronic heart failure, who completed the Pediatric Carvedilol Study 321.~     Carvedilol will be provided as open-label therapy for a period of at least 6 months (or until~     termination of the study) by SmithKline Beecham Corporation d/b/a GlaxoSmithKline (GSK) or~     the University Sponsor.~   "
261302|NCT00129350|"~     At present, a specific community based rehabilitation programme for lung or heart-lung~     transplant recipients does not exist. 160 hospitals throughout the United Kingdom (UK) offer~     pulmonary rehabilitation programmes. The programmes operate under evidence-based guidelines~     as outlined by the Chartered Society of Physiotherapy. Increasing evidence shows that~     rehabilitation programmes help improve performance, exercise endurance, and quality of life;~     and reduce symptoms and demand on health-care resources. This study proposes to compare the~     outcomes of lung and heart-lung transplant patients attending local pulmonary rehabilitation~     against others receiving the Trust's current document-based programme. The study is a~     randomized controlled trial:~        -  Control Arm: Those patients randomized to the 'control' arm will receive the Trust's~          standard rehabilitation programme that consists of an information pack supplied upon~          discharge. They will then complete and undertake the following tests: Short-Form 36 (SF~          36; version 2) Questionnaire, Chronic Respiratory Questionnaire (CRQ-SR), Incremental~          Shuttle Walk Test and Spirometry forced expiratory volume in 1 second (FEV1) and forced~          vital capacity (FVC). The patient will follow the information contained in the~          information pack and the above tests and questionnaires will be repeated 6 months post~          discharge.~        -  Experimental Arm: A patient who is randomized to the 'experimental' arm will be asked to~          complete the following tests upon discharge: Short-Form 36 (SF 36; version 2)~          Questionnaire, Chronic Respiratory Questionnaire (CRQ-SR), Incremental Shuttle Walk Test~          and Spirometry FEV1 and FVC. Three months post discharge, the patient will be enrolled~          into a local pulmonary rehabilitation programme. The programme is typically structured~          to last 6-12 weeks. The above tests and questionnaires will be repeated 6 months post~          discharge.~      To measure the effectiveness of either the information pack or the rehabilitation programme~     the following endpoints will be subjected to analysis in both the experimental and the~     control group:~        -  Short-Form 36 Questionnaire;~        -  Chronic Respiratory Questionnaire;~        -  Incremental Shuttle Walk Test;~        -  Borg Scale;~        -  Spirometry FEV1 and FVC;~        -  Hospital re-admission rates and mortality rates.~      The undertaking of a multidisciplinary-led programme of rehabilitation facilitates a better~     quality of life than a document-based rehabilitation programme in lung and or heart-lung~     transplant out-patients.~      The aim of the study is to construct an optimal programme of rehabilitation in lung or~     heart-lung patients.~   "
261303|NCT00129337|"~     The purpose of this study is to determine the safety of bavituximab when administered via a~     vein, and to examine how bavituximab behaves in the body - how quickly it is taken up by the~     body and how long it stays there. The effect of bavituximab on tumor responses will also be~     examined.~   "
261339|NCT00128856|"~     This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT~     neoadjuvant regimen in patients with stage III breast cancer, confirmed by true-cut or open~     biopsy.~   "
261304|NCT00129324|"~     The goal of the HOME Study is to quantify the impact of low-level fetal and early childhood~     exposures to environmental toxicants including lead, mercury, and other metals, pesticides,~     polychlorinated biphenyls (PCBs), persistent organic pollutants (PBDEs/PFCs), phthalates,~     phenols, environmental tobacco smoke, and alcohol on child development, neurobehavior,~     health, and growth. The HOME Study will also evaluate meconium as a biomarker for fetal~     exposure and test the effectiveness of home repairs to control lead hazards and injuries in~     early childhood.~   "
261305|NCT00129311|"~     Despite the widespread use of nicotine replacement therapies for the treatment of nicotine~     dependence, many smokers are still unable to quit smoking. The purpose of this study is to~     determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.~   "
261306|NCT00129298|"~     Many opioid-dependent individuals are also dependent on cocaine. Methadone is a widely used~     and effective method for treating opioid dependence. However, it is not effective in treating~     other drugs of abuse. The purpose of this study is to determine the effectiveness of another~     drug, tiagabine, for treating cocaine dependence in opioid-dependent individuals already~     receiving methadone treatment.~   "
261307|NCT00129285|"~     Despite years of active research, there are still no approved medications for the treatment~     of cocaine dependence. The purpose of this study is to determine the effectiveness of~     modafinil in treating cocaine-dependent individuals.~   "
261308|NCT00129272|"~     Little is known about the best ways to help young people stop smoking. Bupropion (a~     medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The~     purpose of this study is to determine if bupropion is also effective in treating smokers~     between the ages of 12 and 25 years old. This study also compares the effectiveness of~     bupropion used as a supplement to behavioral treatment versus behavioral treatment used~     alone. In addition, the study evaluates whether hormonal response to stress measured prior to~     the start of treatment predicts whether individuals respond well to treatment with~     medication.~   "
261309|NCT00129259|"~     Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 [Ala-Ala],teplizumab, MGA031) is a humanized~     antibody that is commonly used to prevent organ rejection. The purpose of this study is~     determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1~     diabetes.~   "
261310|NCT00129246|"~     This study will test a combination of the drugs naltrexone and bupropion with~     weight-concerned smokers to investigate whether or not this combination of drugs improves~     smoking cessation quit rates and minimizes post quit weight gain.~   "
261311|NCT00129233|"~     Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin~     Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the~     cardiac- and reno-protective effects of these drugs. However, these recommendations could not~     be extrapolated to Japanese patients, because Japan has been known as a country with a low~     incidence of coronary artery disease and a high incidence of cerebrovascular disease.~     Furthermore, calcium channel blockers (CCBs) also were protective against renal function as~     well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test~     whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.~   "
261312|NCT00129220|"~     The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic~     or mixed symptoms associated with bipolar I disorder.~   "
261313|NCT00129207|"~     The purpose of this study is to investigate how ketoconazole (Nizoral) affects the~     pharmacokinetics (how the study drug is affected by the body and broken down) and~     pharmacodynamics (how the study drug acts on the body) of the active ingredient in the study~     drug Velcade (bortezomib).~   "
261314|NCT00129194|"~     The primary purpose of the study is to assess the safety and pharmacokinetics of KP-1461~     given every 12 hours for 14 days when administered to HIV+ patients who have failed multiple~     highly active antiretroviral therapy (HAART) regimens. Patients currently on HAART will be~     required to discontinue all HAART medications for up to 6 weeks after screening eligibility~     has been determined.~   "
261315|NCT00129181|"~     This study investigates whether there is a change in 123iodine-2ß-~     carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with~     levodopa compared to either dopamine agonist or placebo.~   "
261316|NCT00129168|"~     Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing~     or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making~     cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and~     cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.~   "
261317|NCT00129155|"~     In this study, treosulfan is evaluated for conditioning in allogenic stem cell~     transplantation. The procedure and the follow-up are the same as in standard allogenic~     transplant.~      The donor is unrelated (identical HLA). The graft is haematological peripheral blood stem~     cell.~      The conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan~     (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).~   "
261318|NCT00129142|"~     Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural~     hormone called testosterone. This type of therapy is very effective for the treatment of~     prostate cancer. However, one of the side effects is bone loss or thinning of the bones that~     can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The~     purpose of the study is to determine whether or not the addition of toremifene citrate (the~     study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate~     its impact on side effects associated with testosterone reduction therapy.~   "
261319|NCT00129129|"~     This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT~     vaccine compared to a control group receiving licensed Hib conjugate vaccine, each~     administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups~     A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.~      The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a~     booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age.~     The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to~     receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.~   "
263322|NCT00102128|"~     Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells~     removed from the thigh muscle) into scarred areas of heart muscle after heart attack.~   "
261321|NCT00129090|"~     According to amendment 3 this study addresses the question if intensification of~     administration of rituximab in standard treatment for patients with newly diagnosed~     aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better~     time to treatment failure (TTTF)~   "
261322|NCT00129077|"~     The purpose of this study is to identify the incidence of scratches on the surface of the eye~     in children who cannot blink due to medication use and to identify how best to reduce the~     risk of a scratch on the surface of the eye when patients are using specific medicines.~   "
261323|NCT00129064|"~     An electronic referral application will be developed and integrated into the existing~     outpatient information system. The primary goal of this software is to improve the quality~     and coordination of patient care by increasing physician-to-physician communication. The~     investigators anticipate that improved communications will also enhance physician and patient~     satisfaction and provide cost savings. These outcomes will be formally evaluated following~     implementation of the application.~   "
261324|NCT00129051|"~     Radiation treatment is often used to treat cancer that has spread to the abdomen. It can be~     very effective at relieving symptoms such as pain, but the radiotherapy itself can cause~     side-effects such as cramping and diarrhea. This study will investigate whether it is~     possible to reduce the unwanted side-effects of radiotherapy with a new technology called~     helical tomotherapy. Tomotherapy is a new way to deliver radiation in a much more accurate~     fashion than is currently done, and with less radiation being delivered to normal tissues~     around the tumor. This study will involve the treatment of 20 patients, who have a spread of~     their cancer within the abdomen and pelvis, using helical tomotherapy. The dose and energy of~     radiation will be the same as is currently used - only the delivery system is different. The~     purpose is to assure that tomotherapy is a safe way to deliver radiation treatment and to~     investigate whether it will reduce the toxicity of radiation treatment in these patients.~     Patients will be treated in groups of three until all 20 have been treated. The toxicity of~     treatment will be measured with a questionnaire for each one. If any unexpected severe~     treatment complications occur, further accrual will stop.~   "
261325|NCT00129038|"~     The primary objective of this study is to assess whether adding modified-release dipyridamole~     to aspirin (Asasantin Retard) has measurable effects on markers of platelet function (for~     example, platelet aggregation) in patients with cardiovascular disease who are known to be~     resistant to aspirin alone~   "
261326|NCT00129025|"~     Many patients with localized prostate cancer choose radiotherapy for treatment. Recent~     improvements in technology have lead to better outcomes with less side effects and better~     disease control rates by allowing high doses of radiation to be delivered to the cancer with~     lower doses to surrounding healthy tissues. Currently patients are required to attend daily~     treatments over seven to eight weeks which can be costly and disruptive for patients,~     especially those not living close to a cancer centre.~      There is recent research that suggests that the same or better outcomes might be achieved in~     prostate cancer by delivering a smaller number of treatments, but with a higher dose of~     radiation given on each visit, over a shorter time than the usual seven to eight weeks.~      In this study the investigators propose to treat patients with prostate cancer using 16~     treatments over four weeks, thus reducing the number of visits to the cancer centre for~     treatment by 50%.~   "
261327|NCT00129012|"~     Non-small cell lung cancer (NSCLC) is a disease that often cannot be surgically operated on.~     As a result, treating the tumor with radiation has become the main standard of treatment.~     Radiation therapy though, is limited by various factors, including the difficulty in properly~     imaging the lung tumor since the lung can move up to 4 cm between breathing in and out.~     Consequently, a radiation oncologist must consider a larger area of the lung to treat with~     radiation - increasing the amount of normal tissue exposed to harmful rays and therefore~     leading to increased side-effects. Two techniques being explored into improving tumor~     management while minimizing the side effects in NSCLC are breath-held gating and tomotherapy.~     Breath-held gating is a technique for consistently imaging the tumor at the right moment in a~     patient's breathing cycle - decreasing the normal tissue exposed to harmful radiation.~     Tomotherapy, a new technique in delivering radiation, will further allow the investigators to~     focus treatment on the tumor and exclude more normal tissues. Therefore, they hope that these~     methods will prove to be a better way in treating people with NSCLC.~   "
261328|NCT00128999|"~     Lung cancer is the leading cause of cancer-related mortality in the United States (US) and~     Canada. Because of the high incidence and mortality of this disease, small improvements in~     the management of this disease translates into large numbers of patients having improved~     outcomes after treatment. Radiation therapy is widely used to treat patients with lung~     cancer. However, the radiation dose to the tumor has been limited by the proximity of normal~     structures to the tumor, such as the lung, the spinal cord and the esophagus. The normal~     structures must not be exposed to excessive radiation doses. A new technique, called~     intensity-modulated radiotherapy delivers radiation to tumors such that the normal structures~     around the tumor are exposed to less radiation than previously achievable. This technique is~     already used to treat head and neck cancers. This study will use this technique to deliver~     more intensified radiation to the lung tumor after the patient receives two cycles of~     chemotherapy. A new imaging technique, called positron emission tomography (PET), has been~     found to be more sensitive and specific at detecting the extent of the tumor in the lung than~     the older imaging technique of computed tomography (CT). This study will use both the PET and~     CT to target the radiation beams. Following treatment, the patients will be followed up to~     assess the side effects of normal tissues and response of the tumor to the treatment.~   "
261329|NCT00128986|"~     Although malignant brain tumors are the most common type of primary brain tumor, there are a~     number of other benign brain tumors that exist. Many difficulties exist with treating these~     tumors that have led to controversies in the best treatment. A common issue among these brain~     tumors is the risk of long term side effects from treatment. What limits the use of curative~     radiation therapy is the ability to deliver a maximal dose to the tumor while minimizing the~     amount of radiation to the normal structures in the brain. A new method of delivering~     radiation, called tomotherapy, has been acquired at the Cross Cancer Institute (CCI) and will~     be used in this study. It has the ability to deliver a high dose of radiation to the tumor~     while minimizing the amount of radiation to normal brain structures. This study will use this~     method of radiation therapy to deliver radiation and see if the long term side effects from~     radiation therapy can be reduced.~   "
261330|NCT00128973|"~     This study will evaluate patients with abnormal immune function that results in recurrent or~     unusual infections or chronic inflammation. This may include inherited conditions, such as~     X-linked severe combined immunodeficiency (XSCID), chronic granulomatous disease (CGD), and~     leukocyte adhesion deficiency (LAD), or conditions resulting from outside factors, such as~     graft-versus-host disease (GVHD). The information from this study will be used to establish~     the pattern and pace of change of the disease and to help develop new treatments. The period~     of observation and study following enrollment in this study may be for up to one year. In~     addition these studies may provide the medical information needed to determine eligibility~     for enrollment in other clinical study protocols and more prolonged follow up.~      Patients of any age with abnormal immune function who have recurrent or unusual infections,~     whose blood tests show evidence of immune dysfunction, or who have GVHD, XSCID, CGD or LAD~     may be eligible for this study. Patients' parents, siblings, grandparents, children, aunts,~     uncles and first cousins of any age also may be included. Healthy normal volunteers between~     18 and 85 years of age are recruited as controls.~      Normal volunteers undergo a physical examination and provide blood, saliva, and urine samples~     for immune function studies. Patients' family members provide a medical history, have a~     physical examination, and give blood and urine samples, and possibly a saliva sample. The~     samples are used for genetic and routine laboratory studies. Investigators may request tissue~     samples, such as biopsy specimens, previously removed for medical reasons to be sent to NIH~     for study. Patients undergo the following tests and procedures:~        1. Medical history and physical examination.~        2. Blood and urine tests, including analysis for genes involved in immune disorders.~        3. Buccal smear (in some patients) for genetic studies. This involves scraping the lining~          of the mouth near the cheek.~        4. Specialized tests to evaluate specific conditions in patients who have an immune~          disorder that might affect lung function, gum infections or eye problems. These may~          include chest x-ray, CT scan, breathing function test, dental, eye, and hearing~          examinations.~        5. Follow-up visits of patients with immune problems may occur at 6 months and at one year~          after the first visit (or more frequently if medically required) to include:~             -  Medical history update~             -  Physical examination~             -  Follow-up on abnormal test results and medical treatments initiated at NIH~             -  Collection of blood, saliva, urine, or wound drainage samples for repeat immune~               function studies~             -  Tissue study of specimens removed for medical reasons at other institutions besides~               NIH~   "
261331|NCT00128960|"~     This study will evaluate the long-term functional status, psychosocial adjustment and quality~     of life of patients with different types of diseases and conditions who have had an~     allogeneic (donor) stem cell transplant. Information from this study may help patients and~     families know better what they may expect long-term after transplant and will help health~     care workers improve services to aid in patients' recovery.~      People 18 years of age or older who have had an allogeneic stem cell transplant three or more~     years before the start of this study may be eligible to participate.~      Participants complete a series of questionnaires once a year for three years. The~     questionnaires take about 40 minutes to complete and include information on patient~     demographics, patients' physical, social, and emotional functioning, spiritual well being,~     pain, mental health, general health, fatigue, and other areas of health-related quality of~     life. The questionnaires are completed at home or during normally scheduled follow-up visits~     to the NIH.~   "
261332|NCT00128947|"~     This study will examine how people differ in the way their bodies process and eliminate~     mycophenolate mofetil (MMF), a drug that is used to treat problems affecting the eye and~     immune system and to prevent organ rejection in transplant patients. MMF is metabolized by a~     group of enzymes called UGTs, each of which is made by a different gene. This study will~     investigate whether people with different UGT genes differ in how well their bodies use and~     remove MMF. The results may help scientists learn the best way to give MMF to patients.~      Normal healthy volunteers between 18 and 55 years of age may be eligible for this study.~     Candidates are screened with a medical history, physical examination, and blood and urine~     tests, including a blood test for analysis of genes that control and regulate UGTs. Pregnant~     women and nursing mothers are excluded from the study. Women who are able to have a child and~     men who can father a child must either abstain from sex or use two reliable forms of birth~     control during the study and for 3 months after its completion.~      Participants come to the NIH Clinical Center at 6:30 a.m. on the first day of the study and~     stay in the outpatient clinic for 12 hours. The next 4 mornings, they return to the Clinical~     Center for a single blood collection. The procedures for the 5 days are as follows:~      Day 1~      Upon arrival at the Clinical Center a catheter is inserted into the subject's arm vein. At~     7:00 AM, the subject takes one dose of MMF by mouth with a glass of water. Small blood~     samples are collected through the catheter before the MMF dose and again at 0.5, 1, 1.5, 2,~     3, 4, 6, 8, 10, and 12 hours after taking the drug. Heart rate and blood pressure are~     measured before the blood collection and then every 4 hours. After the last blood sample is~     collected, the volunteer can return home.~      Days 2-5~      Volunteers come to the Clinical Center at 7:00 AM on study days 2, 3, 4, and 5 for a single~     blood draw, collected using a needle.~      Volunteers are contacted by telephone 1, 2, and 3 months after completing the study to see~     how they are doing and to check on their pregnancy status and use of appropriate birth~     control.~   "
261333|NCT00128934|"~     The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE)~     is effective in treating the symptoms of severe premenstrual syndrome (PMS).~   "
261334|NCT00128921|"~     Velcade (bortezomib, PS-341) has recently been approved by the Food and Drug Administration~     (FDA) for the treatment of multiple myeloma for patients who have received at least one prior~     therapy. Velcade is a unique compound developed by scientists at Millennium Pharmaceuticals,~     Inc. Velcade enters cells and affects the way they divide. Cancer cells are particularly~     sensitive. Velcade interferes with the enzyme proteasome which is responsible for allowing~     cells to divide. When cancer cells cannot divide, they die. Velcade falls into the class of~     drugs known as proteasome inhibitors.~   "
261335|NCT00128908|"~     This is an open label, crossover pilot study to explore the safety and efficacy of a rapid~     cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus~     harboring genotypic resistance to at least three classes of antiretroviral therapy.~   "
261336|NCT00128895|"~     Treatment of patients with PR3-ANCA-associated vasculitis consists of two phases: remission~     induction with highly effective, but also relatively toxic, drugs and, secondly, after~     remission is achieved, maintenance therapy with less toxic drugs. Currently,~     remission-maintenance therapy with azathioprine is stopped after approximately 18 months.~     However, the optimal duration of azathioprine maintenance therapy is unknown.~      The investigators have found that patients with PR3-ANCA-associated vasculitis who remain~     cytoplasmic anti-neutrophil cytoplasmic autoantibody (C-ANCA) positive after induction of~     remission have an increased risk to experience relapse of disease. Therefore they will test~     whether relapse risk in these patients can be reduced by extending maintenance therapy at the~     cost of acceptable therapy related toxicity. After induction of stable remission, ANCA will~     be measured by immunofluorescence (IIF). C-ANCA positive patients will be randomized for~     either standard therapy with azathioprine (until 18 months after diagnosis), or longterm~     azathioprine maintenance therapy (until 48 months after diagnosis).~   "
261337|NCT00128882|"~     The purpose of this study is to describe the effect of anti-D on symptoms and platelet count~     in children suffering from unexplainable low platelet counts, when anti-D is administered as~     an injection under the skin. The hypothesis is that the injection with anti-D under the skin~     is as effective as anti-D given in a vein.~   "
261338|NCT00128869|"~     This study aims to compare whether or not there is a difference in the effectiveness of upper~     back (thoracic spine) mobilizations versus manipulations used in a population of patients~     with mechanical neck pain. The investigators hypothesize that patients receiving a~     manipulative technique will experience better outcomes than patients receiving the~     mobilization techniques and these results will be evident at a 48-hour follow-up.~   "
261340|NCT00128843|"~     This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy~     of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One~     hundred postmenopausal patients, with metastatic, positive hormone receptor breast cancer~     will be enrolled in this trial.~   "
261341|NCT00128830|"~     The purpose of this study is to evaluate the long-term safety and tolerability of etravirine,~     administered as part of an individually optimized antiretroviral therapy (ART), in human~     immunodeficiency virus Type 1 (HIV-1) infected participants.~   "
261342|NCT00128817|"~     Surgery with post operative radiotherapy (PORT) had been the mainstay of treatment for~     advanced laryngeal-pharyngeal cancers (ALHC) until the eighth decade of the past century.~     Total laryngectomy with post-operative radiotherapy (TL + PORT) used to result in permanent~     tracheostomy and loss of speech.~      Early trials like the VA or European Organisation for Research and Treatment of Cancer~     (EORTC) trials compared surgery with post-operative radiotherapy to induction chemotherapy~     (ICT) and radiotherapy (RT). Subsequent attempts have been focused on the added benefit of~     including concurrent chemotherapy. There is no randomized trial available in the literature~     comparing concurrent chemoradiation with the standard treatment, i.e. surgery followed by~     radiotherapy. However, most of the studies comparing neoadjuvant chemotherapy and~     radiotherapy reported better locoregional control rates and better survival rates with~     surgery followed by post-operative chemotherapy. Further, the advances in primary voice~     rehabilitation have substantially improved the quality of life after laryngectomy. Thus,~     there is a strong case for comparing the results of concurrent chemo-radiation with surgery~     and post-operative radiotherapy in a randomized clinical trial. This trial will answer the~     question - whether we are saving voice at the cost of life.~      The investigators propose to randomize 900 patients of laryngeal and hypopharyngeal cancers~     in surgery with PORT and a concomitant chemoradiation arm and compare the survival and~     locoregional control rates.~   "
261343|NCT00128804|"~     A controlled dietary intervention study will be carried out based on the stable isotope~     method the investigators have developed to quantify both the absorption of beta-carotene and~     its bioconversion to retinol in oil and in a mixed diet. For 4 weeks the participants will~     consume 2 capsules/day, 7 days/week with each capsule containing 100-mg [13C10] beta-carotene~     and 100-mg [13C10] retinyl palmitate. For two weeks they will consume a diet with high levels~     of beta-carotene in vegetables and fruits and for the other 2 weeks they will consume a diet~     with low levels of beta-carotene in vegetables and fruits supplemented with an extra amount~     of beta-carotene in oil. Samples of blood and faeces will be taken. The study hypothesis is~     that the absorption of beta-carotene in oil in comparison with the absorption of~     beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators want to~     measure the influence of the food matrix of vegetables and fruits on the absorption of~     beta-carotene in ileostomy patients on a western diet.~   "
261344|NCT00128791|"~     In patients admitted with acute myocardial infarction, there is a total occlusion of a~     coronary artery. Even after emergency catheterization and angioplasty, in some patients, the~     resumed blood flow is suboptimal and impacts on heart function. The study is aimed at~     examining whether nitroprusside, an anti-hypertension medication, given directly into the~     coronary artery, can improve the blood flow after the removal of the obstruction that caused~     the infarction.~   "
261345|NCT00128778|"~     This is a randomized, prospective and multicenter phase IV clinical trial, which has been~     designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be~     recruited in the study.~   "
261346|NCT00128765|"~     In this randomized controlled trial, three contemporary modes for chronic obstructive~     pulmonary disease (COPD) management in Dutch general practices are compared for costs and~     effects:~        -  usual general practitioner (GP) care (at patient's initiative);~        -  regular practice nurse review; and~        -  integrated self-management education.~      All three interventions are based on existing guidelines, materials, and field experiences.~   "
261347|NCT00128752|"~     A controlled dietary intervention study will be carried out based on the stable isotope~     method the investigators have developed to quantify both the absorption of beta-carotene and~     its bioconversion to retinol in oil and in a mixed diet. For 6 weeks the participants will~     consume 2 capsules/day, 7 days/week with each capsule containing 50-mg [13C10] beta-carotene~     and 50-mg [13C10] retinyl palmitate. For three weeks they will consume a diet with high~     levels of beta-carotene in vegetables and fruits and for the other 3 weeks they will consume~     a diet with low levels of beta-carotene in vegetables and fruits supplemented with an extra~     amount of beta-carotene in oil. Samples of blood and faeces will be taken.~      The study hypothesis is that the absorption of beta-carotene in oil in comparison with the~     absorption of beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators~     want to measure the influence of the food matrix of vegetables and fruits on the absorption~     of beta-carotene in healthy humans on a western diet.~   "
261348|NCT00128739|"~     Twenty-four (2 x 12) patients with intestinal graft versus host disease (GVHD) Grades 2, 3 or~     4 will be treated with budesonide 3mg three times daily or placebo for 12 weeks. All of the~     patients will receive cyclosporine and by mouth (po) prednisone or intravenous (IV)~     methylprednisone with a starting dose of 2mg/kg/day (standard anti-GVHD treatment). Doses of~     steroids will be decreased by approximately 10% or 10mg per week (depending upon patient’s~     weight) upon response to therapy, defined as a decrease of volume of diarrhea by 50% per day,~     decrease in abdominal pain and no presence of bloody stool. Patients with Grades 3 or 4 will~     be withdrawn from the study if there is no response after one week of therapy. Patients with~     Grade 2 may continue with no decrease in prednisone dose until response is achieved.~   "
261349|NCT00128726|"~     The purpose of this study is to determine the safety and efficacy of a continuous combined~     oral contraceptive pill (CCOCP) regimen. The investigators hypothesize that there will be a~     decrease in the number of vaginal bleeding days in the continuous regimen compared to a~     traditional 21/7 regimen. In addition, the investigators hypothesize that there will be~     increased endometrial and ovarian suppression in the CCOCP regimen.~   "
261482|NCT00126919|"~     Children ages 3-17 who are undergoing port access receive both standard care, topical~     medicine for numbing (LMX4), and the study intervention which utilizes ultrasound to speed~     the onset of LMX4 from 30 minutes to 5 minutes. The procedures will be performed on 2~     separate visits to the clinic. The child's pain with the access procedure is evaluated.~   "
261350|NCT00128713|"~     The primary objective of this study is to compare the three study arms of lower, medium, and~     higher dose platelet therapy with respect to the percentage of patients experiencing at least~     one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding~     Scale (Grade 2 bleeding corresponds to bleeding that is moderate, but not severe enough to~     warrant red blood cell transfusion).~      There are a number of secondary endpoints related to platelet transfusions, hemostasis, and~     other concerns. The four most important secondary endpoints will compare the three study arms~     with respect to the following outcomes: 1) platelet utilization rates (total number of~     platelets transfused x 10 ^11); 2) number of platelet transfusion events (frequency of~     transfusions); a transfusion event would be defined as each separate platelet transfusion~     issued by the study site's transfusion service; 3) highest category of bleeding during time~     of study (Platelet Dose Trial Bleeding Scale Grades less than or equal to 1, 2, 3, or 4 by~     arm); and 4) bleeding severity based on number of days with bleeding (total days of bleeding~     and bleeding/thrombocytopenic day), intensity of bleeding, and number of sites with bleeding~     (if such a severity score has been validated and published by the time the study is~     completed).~   "
261351|NCT00128700|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Vatalanib may stop the growth~     of tumor cells by blocking blood flow to the tumor. Giving temozolomide and radiation therapy~     together with vatalanib may kill more tumor cells.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     vatalanib when given together with temozolomide and radiation therapy and to see how well~     they work in treating patients with newly diagnosed glioblastoma multiforme.~   "
261352|NCT00128687|"~     To examine whether the Stanford Health Education and Risk Reduction Training (HEAR2T) program~     , a case management approach, can be effectively used to manage the risk of coronary artery~     disease.~   "
261353|NCT00128661|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing,~     or coming back. Vaccines may help the body build an effective immune response against human~     papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or~     cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective~     than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.~      PURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how~     well it works compared to hepatitis A vaccine in preventing cervical intraepithelial~     neoplasia or cervical cancer in younger healthy participants.~   "
261354|NCT00128635|"~     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody~     TNT-1/B (^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them~     without harming normal cells. This may be an effective treatment for glioblastoma multiforme.~      PURPOSE: This phase I trial is studying the side effects and best dose of ^131I MOAB TNT-1/B~     in treating patients with progressive or recurrent glioblastoma multiforme.~   "
261355|NCT00128622|"~     RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry~     cancer-killing substances directly to the cancer cells. Vaccines made from a gene-modified~     virus and a person's white blood cells may help the body build an effective immune response~     to kill cancer cells. Giving denileukin diftitox together with vaccine therapy may kill more~     cancer cells.~      PURPOSE: This phase I trial is studying the side effects of giving denileukin diftitox~     together with vaccine therapy in treating patients with metastatic cancer that expresses~     carcinoembryonic antigen.~   "
261356|NCT00128596|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~      PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients~     with metastatic liver cancer that cannot be removed by surgery.~   "
261357|NCT00128583|"~     RATIONALE: Vaccines made from tumor cells may help the body build an effective immune~     response to kill tumor cells.~      PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating~     patients with malignant melanoma.~   "
261358|NCT00128570|"~     RATIONALE: An internet-based health behavior program that provides information about physical~     activity, fitness, and nutrition may help participants become healthier and reduce the risk~     of developing cancer.~      PURPOSE: This randomized clinical trial is studying an individualized internet-based health~     behavior program to see how well it works compared to a standard internet-based health~     behavior program in preventing cancer and improving physical activity, fitness, and nutrition~     in participants who are physically inactive with a higher body mass index.~   "
261359|NCT00128557|"~     The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered~     to newborn infants within the first days of life, reduces six-month infant mortality by at~     least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A~     dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene~     supplementation during pregnancy through three months postpartum, gestational age and birth~     size.~   "
261360|NCT00128544|"~     This study is being conducted to compare the effectiveness of the combination of~     valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.~   "
261361|NCT00128531|"~     The purpose of this study is to look at the efficacy and safety of leuprolide acetate in~     patients with prostate cancer.~   "
261362|NCT00128518|"~     The principal scientific objective of the trial is to identify the factors that are~     associated with differential blood pressure responses between drugs. This may allow~     investigators to produce new hypotheses on the pathophysiology of hypertension and on the~     mechanisms of drug action.~      These factors can be of different types:~        -  Environmental factors (sodium or alcohol intake);~        -  Morphological (height, weight, body mass index, body surface area);~        -  Initial blood pressure;~        -  Electrocardiogram (ECG) parameters of left ventricular hypertrophy;~        -  Biological parameters as the activity level of the renin angiotensin aldosterone system;~        -  Genetic polymorphisms.~   "
261500|NCT00126672|"~     RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with~     angiomyolipoma of the kidney.~   "
261363|NCT00128505|"~     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called~     cortisol. Under normal conditions, cortisol and other hormones are created by the body in~     response to physical and emotional stress, triggering a healthy stress response. People who~     suffer from psychotic major depression may have unusually high levels of cortisol circulating~     within them or abnormal patterns of cortisol levels, overloading the stress response~     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If~     Corlux can keep the body's cortisol receptors from being overloaded, the stress response~     system may return to normal function, which may result in improvement of symptoms. The~     purpose of this study is to allow patients who have already participated in an earlier 8 week~     study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment~     with Corlux periodically if a psychotic episode should reappear during a period of one year.~   "
261364|NCT00128492|"~     The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI~     in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).~   "
261365|NCT00128479|"~     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called~     cortisol. Under normal conditions, cortisol and other hormones are created by the body in~     response to physical and emotional stress, triggering a healthy stress response. People who~     suffer from psychotic major depression may have unusually high levels of cortisol circulating~     within them or abnormal patterns of cortisol levels, overloading the stress response~     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If~     Corlux can keep the body's cortisol receptors from being overloaded, the stress response~     system may return to normal function, which may result in improvement of symptoms. The~     purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients~     who have been diagnosed with psychotic major depression (PMD).~   "
261366|NCT00128466|"~     This clinical trial will compare the effectiveness of streptomycin, which historically is the~     standard drug for treatment of plague, with gentamicin. The hypothesis is that gentamicin is~     not inferior to streptomycin but that it will have less severe side effects. The study is~     being done in Madagascar because that country reports the most plague cases in the world.~     Patients coming into a participating clinic with suspected plague (bubonic, pneumonic, or~     septicemic) will be randomized into one of two treatment arms after giving informed consent.~     Patients will be monitored for side effects and for improvement of symptoms.~      In addition, rapid diagnostic test strips have been developed but not fully evaluated for use~     on humans. The investigators will evaluate these new tests on specimens from the same~     patients, comparing their performance with that of classical diagnostic methods such as~     culture and serology.~   "
261367|NCT00128453|"~     The purpose of the study is to determine whether colchicine is safe and effective in the~     treatment of acute pericarditis and the prevention of subsequent recurrences.~   "
261368|NCT00128440|"~     The primary objective of this study was to compare the efficacy and safety of 200 μg and 400~     μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat®~     Inhaler once daily for four weeks in patients with COPD.~   "
261369|NCT00128427|"~     The purpose of the study is to determine whether colchicine is safe and effective in the~     prevention of the postpericardiotomy syndrome.~   "
261370|NCT00128414|"~     The purpose of the study is to determine whether colchicine is safe and effective in the~     treatment and prevention of recurrent pericarditis (first episode).~   "
261371|NCT00128401|"~     This study examines whether an antibiotic, d-cycloserine (DCS), boosts the effectiveness of~     cognitive behavior therapy (CBT) for social anxiety. CBT has been shown to be effective for~     the treatment of social anxiety in children and adults, but even after treatment,~     approximately 40% may remain diagnosable. The antibiotic DCS has been shown to enhance the~     type of learning that is promoted by exposure therapy, a main component of CBT. This study~     will test whether DCS can improve the effectiveness of CBT for social anxiety.~      All participants will receive 12 weekly CBT sessions. In addition to receiving the CBT,~     participants will be randomly assigned (similar to a coin toss) to receive either DCS or a~     placebo (sugar pill). The pill will be taken 1-2 hours prior to each of the 12 CBT sessions.~     The pill is taken only on the 12 therapy days.~      Prior to receiving treatment, participants will be asked to:~        -  participate in interviews to assess diagnosis and how they are doing including mood,~          degree of nervousness and behavior~        -  have a physical examination, a urine test, and an electrocardiogram (EKG)~        -  undergo tests involving problem-solving and memory~        -  prepare and present a speech to a virtual audience using virtual reality goggles~        -  undergo functional magnetic resonance imaging (fMRI) while performing tasks that involve~          looking at pictures, remembering things, testing reaction times, and making simple~          choices~      Those who have not improved by the end of the study will be offered standard antianxiety~     medication treatment for 1 to 3 months. If a participant does not wish to take medication,~     study clinicians will help him/her locate psychological care in the community. Participants~     will be asked to complete a follow-up assessment 3 months after their last CBT session.~   "
261372|NCT00128388|"~     This study will determine the effectiveness of a manualized form of brief psychodynamic~     psychotherapy in comparison with applied relaxation training in treating adults with panic~     disorder.~   "
261373|NCT00128375|"~     The purpose of this study is to test the effectiveness of financial incentives for increasing~     long-term smoking cessation rates among employees at General Electric worksites throughout~     the United States.~   "
261385|NCT00128206|"~     The purpose of this study is to determine whether an alternative drug, (rifampin) given~     daily, is better at treating tuberculosis (TB) and more tolerable than the usual drug~     treatment, isoniazid (INH). Study participants will include 972, TB infected, San Francisco~     Jail inmates, aged 18 or older. One group of volunteers will take INH two times a week for 9~     months, and the other group will take rifampin daily for 4 months. Medication will be~     administered in jail and at the San Francisco TB Clinic if the volunteer is released from~     jail prior to completing the study. Participants will be seen daily for 4 months (rifampin~     group), and 2 times a week for 9 months (INH group) for directly observed therapy. Study~     procedures will include 5 symptom review visits and blood samples for lab testing. Follow-up~     will continue for each subject for five years after enrollment into the study.~   "
261374|NCT00128362|"~     The advent of mammography and increased awareness of breast cancer has resulted in detection~     of smaller tumors, the majority of which would not have had metastasized to the axillary~     lymph nodes. The sentinel node (SN) is presumably the first echelon node in the axillary~     basin to become involved with metastatic breast cancer cells. Sentinel node biopsy (SNB) in~     operable breast cancer has gained popularity since it promises to avoid treatment of the~     axilla when the nodes are negative for metastasis. Advances in technology (radio-guided SNB)~     is associated with a risk of false negative SN reporting in 4-12%. The consequence of leaving~     behind untreated positive non-sentinel nodes in the axilla is a potential risk for axillary~     recurrence. Axillary sampling is a simple and inexpensive procedure in which level I nodes~     are removed by a blind dissection. The investigators critically analyzed the efficacy of both~     the procedures separately in consecutive pilot studies i.e., targeted SNB versus blind~     axillary sampling. The current study is planned as a prospective comparison study where a~     patient undergoes both the procedures in the same surgical intervention and thus provides an~     immediate comparison of the two techniques with respect to their effectiveness.~   "
261375|NCT00128336|"~     The purpose of this trial is to determine the most cost effective programme for overweight~     and obese individuals to maintain weight loss over a 2 year period.~   "
261376|NCT00128323|"~     In resource constrained societies and where HIV is a problem, oral thrush causes significant~     morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are~     relatively expensive compared to GV solution and ketoconazole has significant side effects~     especially in association with some of the treatments for HIV related problems.~      In children, either GV solutions or nystatin are used, GV is a fraction of the cost of~     nystatin.~      GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark~     them out as having HIV infections. A much more dilute solution of GV has proved equally~     effective in vitro and would not carry the same cosmetic problem.~      In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165%~     GV and nystatin oral drops - all masked so that they look the same - to see if GV is more~     effective than nystatin, and to see if the weaker solution of GV is as effective as the~     stronger solution.~   "
261377|NCT00128310|"~     The investigators assume that progression-free survival mean time for patients treated with~     vinorelbine will be 3 months, and for patients treated with gemcitabine plus vinorelbine will~     be 5 months. That implies a reduction in risk ratio of 40% (Hazard ratio = 1,67). Assuming a~     bilateral alpha error of 0.05 and beta error of 10%, and the number of events needed if 60%~     of patients have progressed after 1 year, the number of patients needed per treatment arm is~     114. Considering a 10% post-randomization drop-out, the final number of patients is 252 (126~     per arm).~   "
261378|NCT00128297|"~     The study objective is to evaluate the differences, in terms of first occurrence of a~     skeletal event, in patients with breast cancer and symptomatic bone metastases, when~     pamidronate is administered during 2 years, or when it is administered during 6 months,~     followed by a six month rest period, and again a 6 month treatment period.~   "
261379|NCT00128284|"~     The purpose of this study is to determine the correlation between gastric residence time of~     the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled~     meal as measured by gastric emptying scintigraphy.~   "
261380|NCT00128271|"~     The purpose of this study is to determine the safety and tolerability of bavituximab when~     administered via a vein as a single infusion and to examine how bavituximab behaves in the~     body and how it affects the amount of hepatitis C virus in individuals with chronic~     infection.~   "
261381|NCT00128258|"~     This research study is being performed to find out more information about the safety and~     effectiveness of injecting bone marrow progenitor cells (BMPCs) from one's own hip bone into~     one's heart muscle. The BMPCs are the cells from which the different types of blood and other~     cells grow.~      In patients with heart failure, the heart muscle does not pump well. Over a period of years,~     this continues to get worse until the patient dies of heart failure. The investigators are~     trying to find out if the injection of these BMPCs can make a change in the functioning of~     these areas of the heart muscle. Data from studies around the world have suggested that when~     patients with heart failure receive these cells by direct injection into their hearts they~     show signs of recovered heart function, however, there has been no evidence from actual~     studies of the cells of the patient's hearts to show how this process works. It is the~     investigator's plan to inject an eligible participant's heart with cells that are from one's~     own bone marrow during an operation to receive a ventricular assist device (VAD) or partial~     artificial heart and then to study the function of the heart while awaiting a heart~     transplant. The investigators will then examine the heart after it has been removed as part~     of the regular heart transplant operation for any microscopic changes (changes too small to~     be seen by the unaided eye but large enough to be studied under a microscope) at the site~     where the cells are injected. Participants will have no change in the chances of receiving a~     heart transplant by agreeing to participate in this study. There will also be no delay in~     receiving a VAD operation while waiting to participate in this study. This Phase I study has~     been cleared by the Food and Drug Administration (FDA) to enroll and treat patients. The~     Center for Biologics Evaluation and Research Investigational New Drug number (IND BB #) is~     12304. (A Phase I trial is a research study using techniques or products in the first-stage~     or for the first time in human subjects).~   "
261382|NCT00128245|"~     This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%)~     ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS,~     dry eye syndrome) patients.~   "
261383|NCT00128232|"~     Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma~     causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is~     approved for treatment of acromegaly after surgery if the disease is not controlled. This~     study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who~     did not have any previous treatment for acromegaly.~   "
261384|NCT00128219|"~     The group B streptococcus (GBS) vaccine study is being done to see if a single vaccination~     with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina.~     Approximately 600 women, ages 18-40, will be enrolled from the clinical sites participating~     in this study. Participants will be non-pregnant, sexually active (sex with a male at least~     once in the last 4 months), and GBS negative in the vagina or rectum at the screening visit.~     Participants will be randomly assigned to receive the experimental GBS type III vaccine or a~     licensed vaccine containing Tetanus and Diphtheria Toxoids (Td). Participants will be~     followed at one month, 2 months and every other month thereafter following vaccination (for~     vaginal and rectal swab collection and a blood draw) for 1½ years or a total of 10 post~     vaccination visits.~   "
261409|NCT00127881|"~     The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients~     with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to~     treatment with Targretin® and one other standard therapy.~   "
261386|NCT00128193|"~     The purpose of this study is to see how healthy people and leprosy patients react to 2 new~     skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in~     measuring the number of people exposed to leprosy and enable its diagnosis and treatment at~     an earlier stage. Participant's ages 18-60 living in Kathmandu, Nepal will be enrolled.~     Stages A and B of the study will use the skin test in healthy volunteers. Stage C will use~     the skin test in high risk volunteers (including individuals with leprosy), healthy~     individuals in contact with leprosy patients and individuals with tuberculosis (TB, lung~     disease). Study procedures will include injections, physical exam, and blood testing.~     Injection sites will be checked several times during the participant's study involvement (5~     hours of time spread over approximately 1 month). Volunteers screened for the study, which~     have leprosy or tuberculosis will be treated or referred for treatment.~   "
261387|NCT00128180|"~     The purpose of this study is to see if a drug, called methylprednisolone, is safe and~     effective in people with Hantavirus infection. Individuals 2 years of age or older are~     invited to participate in this study if their doctor suspects or knows they have Hantavirus~     infection. Volunteers will either be given methylprednisolone or placebo (contains no~     medication) through a needle inserted in a vein for 3 days. During the first 7 days of~     hospitalization procedures may include blood tests, physical exams, chest x-rays, and urine~     tests. During study visits on days 14, 28, 84 and 180 after diagnosis, the doctors will ask~     about health, examine the body, take a chest X-ray, collect blood for safety testing and for~     measuring antibodies, and do breathing tests on volunteers. Participants will be involved in~     the study for about 6 months.~   "
261388|NCT00128167|"~     The primary objective of this study is to estimate the relative efficacy and assess the~     safety of CAIV-T compared to TIV.~   "
261389|NCT00128154|"~     The purpose of this study is to determine whether chromium supplements can reduce symptoms of~     metabolic syndrome, a collection of symptoms that increase one's risk for developing heart~     disease, stroke, and diabetes.~   "
261390|NCT00128141|"~     Two groups of preterm infants with birth weight equal to or less than 1500 grams will be~     studied. One group will receive the standard care and the other will receive standard care~     plus maternal special tactile stimulation. Gain of weight, length and head circumference,~     date of the beginning of enteral feedings, length of time to recover birth weight and age of~     hospital discharge will be recorded and compared between both groups.~   "
261391|NCT00128128|"~     This study will determine whether cranberry juice is effective in reducing recurrent urinary~     tract infections (UTIs) in women who have had a UTI within the past year.~   "
261392|NCT00128115|"~     The purpose of this study is to demonstrate an improvement in physical functional recovery,~     following administration of Drug for 24 weeks, in patients who have recently experienced a~     hip fracture. This study will also evaluate the safety and tolerability of Drug.~      This is an early phase trial and some specific protocol information is proprietary and not~     publicly available at this time. (Full information is available to trial participants).~   "
261393|NCT00128102|"~     This is a study to determine the safety, tolerability, and anti-tumor effectiveness of an~     oral investigational drug, suberoylanilide hydroxamic acid, in the treatment of advanced~     malignant pleural mesothelioma.~   "
261394|NCT00128089|"~     This is a preliminary trial of a new dietary approach to the treatment of obesity related~     type 2 diabetes.~      Study terminated December 19, 2005 for administrative reasons.~   "
261395|NCT00128076|"~     This study will compare two different surgical techniques for repairing a tear in the muscles~     of the shoulder (rotator cuff). The investigators will determine whether an arthroscopic or~     mini-open technique provides better quality of life and repair integrity.~   "
261396|NCT00128063|"~     The primary objective of the study is to evaluate the pharmacokinetic behavior of Suc-HSA~     after consecutive daily intravenous (i.v.) doses. The secondary objectives are to evaluate~     the safety and tolerability and the antiretroviral and immunological effects of consecutive~     daily i.v. doses of Suc-HSA.~   "
261397|NCT00128050|"~     Although the role of surgical treatment is still controversial, surgical evacuation of~     intracerebral hematoma is a frequent practice. Rebleeding is a frequent complication in~     patients submitted to hematoma evacuation. It has been reported that smaller postoperative~     volume of hematoma is associated with a better outcome. The investigators hypothesize that~     the administration of Factor VIIa (Eptacog alfa) immediately after surgical evacuation of the~     hematoma can reduce postoperative rebleeding.~      Aims of the Study:~      This study will investigate:~        1. The efficacy of Eptacog alfa in preventing or reducing rebleeding after surgery for~          spontaneous supratentorial ICH; and~        2. The safety of product administration~   "
261398|NCT00128037|"~     The purpose of this study is to evaluate the safety and efficacy of the trimodality~     (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus~     tumors.~   "
261399|NCT00128024|"~     Statins have been shown to prevent coronary artery disease and to preserve left ventricular~     function in dilated cardiomyopathy. The investigators hypothesized that the early use of~     statins would reduce cardiovascular events including heart failure in acute myocardial~     infarction patients. The purpose of this study is to determine whether early (within 96 hours~     after onset) use of any available statins are effective to prevent cardiovascular events~     including heart failure after acute myocardial infarction in Japanese patients.~   "
261400|NCT00128011|"~     The purpose of this study is to evaluate the safety and immunogenicity of a new formulation~     of a locally-produced bivalent, (O-1 and O-139) killed whole cell oral cholera vaccine among~     Vietnamese adults.~   "
261435|NCT00127543|"~     This study is being done to see if education about medicines directed toward children will~     improve their knowledge. The investigators also want to know if this knowledge lasts over~     time. Right now there are few medication instructional cards that are appropriate for~     children. Most of the medication cards provide information for adults. Some studies have~     shown that by teaching children directly, the children may take medicine at the right time~     for the right reason, have fewer side effects and know more about their medicine.~      The purpose of this research study is to see if education about medication helps children~     learn more about their medicine and if this knowledge lasts.~   "
261436|NCT00127530|"~     To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in~     patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled,~     parallel group study.~   "
261401|NCT00127998|"~     Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the~     continuing development of resistance to new antimalarial formulations is one of the major~     obstacles to effective malaria control and case management. Efficient, comprehensive and~     validated methods for monitoring drug resistance in advance of the development of resistance~     to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic~     polymorphisms that give rise to resistant P. falciparum parasites and methods in population~     genetics for evaluating the data can be valuable tools for monitoring drug resistance in the~     field. This study aims to:~        1. Prospectively measure the in vivo response of P. falciparum malaria in Mali to several~          different antimalarial drugs and drug combinations: chloroquine (CQ),~          sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in~          combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate~          (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and~          artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high~          rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested.~        2. Measure the frequencies of molecular markers for antimalarial drug resistance, and~          examine how those results relate to the efficacy of these drugs in treating clinical~          malaria~        3. Measure drug levels at 3 days and correlate with efficacy results.~        4. Examine early clinical, parasitologic, and clinical predictors of late treatment~          failure.~        5. Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide~          resistance surveillance system for antimalarial drugs.~   "
261402|NCT00127985|"~     Background: Systemic corticosteroids are considered in patients with an adverse clinical~     course suffering from conditions like the acute respiratory distress syndrome (ARDS) and~     septic shock. Treated patients not only show improved respiratory function, but also~     hemodynamic status and overall multiple organ dysfunction score.~      Objective: To evaluate the safety and effectiveness of 6-methyl-prednisolone on the clinical~     course of multiple organ dysfunction syndrome (MODS).~      Design: Multi-center, double-blind, randomized, placebo-controlled.~      Intervention: Intravenous administration of 6-methyl-prednisolone or placebo (aqueous~     solution). The duration of the study medication administration protocol is 32 days (1).~      Primary Endpoints:~        1. All cause Intensive Care Unit (ICU) and 28-day mortality~        2. Organ dysfunction score on days 4, 7, 14, and 28 of the protocol.~   "
261403|NCT00127972|"~     It is desirable to obtain extended follow up data on subjects who participated in the 2NN~     study and the CHARM study in order to see if the beneficial effect of using nevirapine~     continues up to 144 weeks of treatment.~   "
261404|NCT00127959|"~     This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in~     antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).~      Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A~     is being conducted. (Substudy A1)~   "
261405|NCT00127946|"~     Hypothesis: Gastroschisis is a localised disruption of the abdominal layer. It occurs early~     in gestation, and the bowel is therefore bathing in the amniotic fluid and can be constricted~     at the level of the abdominal hole. The bowel is therefore submitted to different injuries~     partly attributable to the contact with amniotic fluid contaminated by digestive compounds~     and inducing an inflammatory reaction. Experimental studies on animal models and preliminary~     data in humans indicate that changing regularly the amniotic fluid (i.e. AMNIOECHANGE) would~     improve the outcome of theses fetuses and then neonates.~   "
261406|NCT00127933|"~     This single arm study stratified patients into two treatment cohorts based on HER2-neu~     overexpression/amplification. Each cohort will be independently powered for the primary~     endpoint. The study will evaluate the efficacy, safety and impact on quality of life of~     treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu~     negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv)~     Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same~     chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will~     receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration [po] twice~     daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will~     also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
261407|NCT00127920|"~     The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian~     tube epithelial cancer, and peritoneal cancer is with maximal upfront therapy (Morrow &~     Curtin, 1998). This involves an optimal primary tumor debulking surgery. The most active~     chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin~     have become the standard first line therapy because of proven survival benefits with those~     regimens in treating advanced ovarian adenocarcinoma patients. New chemotherapy agents like~     bevacizumab have demonstrated increased overall and progression free survival benefits in~     metastatic colorectal cancer patients and are being studied for their potential contributory~     impact on the current standard of treatment. Since no triplet regimen has demonstrated~     compelling superiority, the combination of taxol, carboplatin, and bevacizumab is intriguing~     because of their potential synergy, distinct mechanisms of action, and non-overlapping~     toxicity.~      The null hypothesis (Ho) is that the drug regimen will demonstrate an 80% patient response~     rate (RR).~      The alternative Hypothesis (H1): The triplet drug regimen will demonstrate a significantly~     higher patient response rate than standard therapy.~      Hypothesis (H2): The triplet drug regimen will demonstrate a significantly more favorable~     patient time to tumor progression rate than standard therapy.~   "
261408|NCT00127907|"~     Recent studies have suggested that arginine-vasopressin could be more effective in the~     treatment of cardiac arrests. The last published study did not outline obvious improvements~     in the prognosis of all cardiac arrests but pointed out a possible increased survival rate~     when arginine-vasopressin is associated with epinephrine. The aim of this study is to compare~     the efficacy of two successive injections of epinephrine (1 mg) with two successive~     injections of epinephrine associated with arginine-vasopressin (40 UI) in out-of-hospital~     cardiac arrests occurring in adult patients. The primary endpoint is the survival rate at~     hospital admission. The inclusion period lasts 18 months and 2416 patients are planned to be~     enrolled.~   "
267518|NCT00065221|"~     This is a trial to determine the safety and efficacy of ginger in reducing the prevalence and~     severity of chemotherapy induced nausea and vomiting.~   "
261410|NCT00127868|"~     Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate~     tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide~     shampoo has been the gold standard, its strong odor and its drying effect on the scalp~     discourage many patients from using it. Meanwhile, no other antifungal shampoo has been~     rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin~     accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known~     which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to~     cure, nor which do so the fastest.~      Scalp ringworm can also re-occur in the same child. To date, no studies have been done to~     find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp~     ringworm.~      In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis,~     will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly~     assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or~     baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All~     patients will continue using the same assigned shampoo twice weekly for 24 weeks, while~     continuing to return to clinic every 4 weeks for scalp evaluation.~   "
261411|NCT00127855|"~     This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine~     compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine~     and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody~     persistence and immune responses to polysaccharide vaccine boosters were additionally~     assessed at 11 to 14 months of age.~   "
261412|NCT00127842|"~     The overall objective of the study was to describe the long-term effectiveness and safety of~     etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.~   "
261413|NCT00127829|"~     This study will determine the safety profile and maximum tolerated dose (MTD) of orally~     administered gefitinib on a weekly and twice weekly schedule.~   "
261414|NCT00127816|"~     Permanent prostate implants are a type of radiation therapy in which a high dose of radiation~     is delivered to cancerous tissue by many small radioactive seeds. Studies of early-stage~     prostate cancer patients treated in this way and followed for 10 - 12 years indicate a cure~     rate of about 80%. This result is similar to surgery and other forms of radiotherapy, but~     comes with fewer side effects and greater convenience for the patient. Further studies show~     that the radiation dose delivered is the most important factor in achieving a cure. At~     present this dose is estimated by a computer, using a computed tomography (CT) scan of the~     patient and a simple calculation method. The dose estimate is not as accurate as it could be,~     however, because the precise extent of the prostate is hard to determine from the CT scan,~     and the calculation method does not make use of information about patient body tissues. The~     researchers propose to eliminate these inaccuracies by using magnetic resonance imaging (MRI)~     to identify the prostate gland and by developing an improved dose calculation algorithm that~     includes information about patient tissues. This new approach will allow physicians to assess~     implant quality with greater certainty, improve their implant technique, and ultimately~     increase the cure rate to as much as 95%.~   "
261415|NCT00127803|"~     The purpose of this study is to determine the safety and tolerability of a modified C.~     difficile vaccine at 3 dose levels compared with a placebo control administered via~     intramuscular injection in healthy adults aged 18-55 years of age.~   "
261416|NCT00127790|"~     Several studies have shown that behavioral therapy for chronic pain can be beneficial for~     chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia.~     However, seldom do chronic pain patients with insomnia receive a behavioral treatment for~     insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful~     for pain and whether treatment for pain is helpful for insomnia. It will also assess whether~     a combined treatment is any more or less effective for pain or for sleep. Finally, the study~     will assess whether any of these treatments leads to improvements in immune function.~   "
261417|NCT00127777|"~     This was a randomized, multi-center, partially placebo-controlled Phase IV study to compare~     the efficacy and tolerability of a 48-week combined therapy with pegylated interferon~     alpha-2a, ribavirin and amantadine sulphate versus placebo in untreated patients with chronic~     hepatitis C virus-genotype-1-infection. The hypothesis was that there will be an increase in~     sustained response rate for triple therapy compared to current standard treatment.~   "
261418|NCT00127764|"~     By this study, the investigators want to test if the value of adjuvant pulse glucocorticoid~     therapy for pemphigus can be determined by comparing an experimental arm (dexamethasone pulse~     therapy, prednisolone, and azathioprine) with a control arm (placebo pulse therapy,~     prednisolone, and azathioprine). The investigators will determine the rate of complete~     remission with dexamethasone pulse therapy; the time needed for complete remission; and the~     duration of remission, and compare these data with those of the placebo arm.~   "
261419|NCT00127751|"~     The primary objective of this study was to evaluate the effectiveness of a multifactor~     cardiovascular disease (CVD) risk reduction program using team case management in high risk~     patients who have low family incomes and limited access to medical care. Patients were~     randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month~     evaluations of CVD risk factors, clinical status and quality of life.~   "
261420|NCT00127738|"~     The RAVE study will compare renal revascularization to medical management for people with~     atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.~   "
261437|NCT00127517|"~     The purpose of this study is to determine whether patients with advanced cancers who receive~     AVR118 solution for injection into the skin can achieve improvement in quality of life. Based~     on a study in patients with AIDS, possible benefits may include improved appetite and~     strength; weight gain; improved mood; and decreased fatigue. For the first three weeks, some~     patients receive AVR118, and others receive placebo (an injection expected to have no~     benefits). After three weeks, all patients will be offered the opportunity to take injections~     of AVR118.~   "
261438|NCT00127504|"~     The purpose of this study is to determine whether rifampin and/or azithromycin are effective~     in the treatment of river blindness (onchocerciasis).~   "
261439|NCT00127491|"~     The purpose of this study is to see whether esophageal pressure (PES) measurements will allow~     the investigators to choose the best method of mechanical ventilation in patients with acute~     lung injury (ALI).~   "
261421|NCT00127725|"~     Fractures of the tibial shaft (diaphysis) are some of the most common long bone fractures.~     They most frequently occur in males less than 40 years of age. Despite advancements in the~     surgical management of these fractures, the precarious blood supply and lack of soft-tissue~     cover of the shaft of the tibia make these fractures vulnerable to non-union and infection.~     These complications often require multiple procedures, extended time off of work, and can~     result in ongoing poor mobility. This is reflected in the surgical revision rate that the~     scientific literature has recorded as being between 20 and 30%.~      Pulsed electromagnetic field (PEMF) stimulation has been shown to be a safe and effective~     treatment for non-unions of the tibia. These are fractures in which the bone has failed to~     unite and the healing process has ceased. The PEMF is delivered via a device such as the EBI~     Bone Healing System®, which straps onto the limb overlying the fracture. It is lightweight~     and portable using a rechargeable battery for power. It is compatible with internal and~     external fixation and may also be worn over a plaster or fibreglass cast. It is usually kept~     in place for ten hours per day and used for a period of three months or until the fracture~     unites. In animal models, PEMF stimulation has been demonstrated to improve the time to~     fracture healing in acute fractures. There have been no demonstrated side effects of the~     therapy.~      The study hypothesis is that PEMF stimulation during the first twelve weeks after fracture,~     in addition to normal surgical care, will increase the union rate for these fractures and~     thereby significantly reduce the surgical revision rate within the first twelve months~     following fracture.~   "
261422|NCT00127712|"~     The investigators hypothesize that the medication amiodarone decreases the incidence of~     atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are~     to:~        -  Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac~          open-chest surgery;~        -  Determine the influence of the prevention of AF following non-cardiac thoracic surgery~          on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical~          duration of stay in a hospital unit that employs cardiac monitoring; and duration of~          post-surgical hospital stay; and~        -  Determine the safety of amiodarone for the prevention of AF following non-cardiac~          open-chest surgery.~   "
261423|NCT00127699|"~     In the United States (U.S.) there currently is no standard method of umbilical cord care,~     resulting in varying practices within and across institutions. These differences may result~     in an increase in morbidities for newborns such as the formation of umbilical granulomas and~     increases in acute care utilization. This study will determine which of two common methods of~     caring for newborn umbilical cords is superior - triple dye, followed by the application of~     rubbing alcohol, or triple dye alone.~   "
261424|NCT00127686|"~     Cough is the most common reason for an acute care doctor's visit in the United States. Cough~     can affect sleep for both coughing children and their parents. The American Academy of~     Pediatrics does not endorse the use of dextromethorphan (DM), the most common~     over-the-counter (OTC) cough medication because of a lack of efficacy data and some potential~     for toxicity, particularly when taken in excess. In fact, DM has previously been shown to be~     no better than a placebo for cough in children. Therefore, alternative, therapeutic agents~     are needed. Honey anecdotally provides relief for symptoms due to upper respiratory tract~     infection (URI). This study seeks to use a survey to evaluate whether a single dose of honey~     and/or DM is better than no treatment at all for controlling nocturnal cough in children with~     URI and the effect of the treatments on sleep quality for coughing children and their~     parents. A single dose of honey or DM will be superior to no treatment for control of~     nocturnal cough due to upper URI as rated by both parents and children and will improve the~     sleep quality for those children and parents. Compared to DM, honey will be superior for~     controlling nocturnal cough due to upper URI (also based on child and parental report).~   "
261425|NCT00127673|"~     This study will compare the short- and long-term effectiveness of two different treatments~     for people with post-traumatic stress disorder.~   "
261426|NCT00127660|"~     A study examining menu choices made at fast food restaurants.~   "
261427|NCT00127647|"~     The purpose of this trial is to evaluate the efficacy and safety of an investigational drug~     in adult patients with allergic rhinitis.~   "
261428|NCT00127634|"~     This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the~     Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking~     patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month~     follow-up period.~   "
261429|NCT00127621|"~     This is a phase III trial comparing early tracheotomy versus prolonged endotracheal~     intubation in intensive care unit patients needing prolonged ventilatory support.~   "
261430|NCT00127608|"~     This study is conducted in order to collect clinical samples from patients who are diagnosed~     of having chickenpox infection. The results of this study will provide basic scientific~     information about chickenpox disease.~   "
261431|NCT00127595|"~     This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine~     (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of~     the urothelial tract.~   "
261432|NCT00127582|"~     This is a prospective multicentric Italian study to evaluate the arrhythmic risk in myotonic~     dystrophy type 1.~   "
261433|NCT00127569|"~     This trial is aimed to study the efficacy of 4 weekly cycles of rituximab in HIV-infected~     patients with multicentric Castleman disease (giant lymph node hyperplasia) dependent on~     chemotherapy. Efficacy is assessed by the complete response rate at day 60. The patients are~     followed until day 365.~   "
261434|NCT00127556|"~     This study concerns the safety of blood transfusion. Prior to transfusion, staff should~     perform a number of essential safety checks to ensure that the correct patient is receiving~     the correct blood product. Evidence suggests that these safety checks are not always done.~     This study has been designed to assess the effect of a simple intervention on the performance~     of the bedside safety check.~      The hypothesis is that a simple intervention will improve the performance of the bedside~     check.~   "
261440|NCT00127478|"~     The primary purpose of the study is to evaluate long-term safety and tolerability of~     atrasentan 10 mg in men with hormone refractory prostate cancer.~   "
261619|NCT00125112|"~     The purpose of this study is to determine if an internet-based intervention designed to~     reduce binge eating and improve healthy weight regulation skills will result in reductions in~     binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.~   "
261441|NCT00127465|"~     Objective: To explore the hypothesis that different methods of selecting and printing~     information for cancer patients could improve emotional support by affecting interaction with~     others, and so lead to improved psychological wellbeing.~      Design: Randomised trial with 8 groups (three factors, 2X2X2). Data collected at recruitment~     and three month follow-up.~      Participants: 400 patients starting radiotherapy and their 'confidant' (the person in who~     they confide).~      Interventions: Printed booklets.~        1. Half had 'general' CancerBACUP information for that cancer; half had 'personal'~          information from the medical record plus selected general information;~        2. Half chose information by 'interacting' with the computer; half had a larger volume of~          material in booklets that were produced 'automatically'.~        3. Half had additional 'anxiety management advice'.~      Outcomes: Patients' views; use of booklet with others; change in reported social support;~     change in anxiety and depression.~   "
261442|NCT00127452|"~     The Alpha Omega Trial is a randomized, placebo-controlled, double-blind dietary intervention~     study in 4837 postmyocardial infarction patients in the Netherlands to examine whether~     incidence of cardiovascular diseases during 40 months of follow-up can be prevented by low~     doses of omega-3 polyunsaturated fatty acids. The key objectives are:~        -  to examine the effect of low-dose supplementation (400 mg/day) of eicosapentaenoic acid~          and docosahexaenoic acid on incidence of cardiovascular diseases; and~        -  to examine the effect of low-dose supplementation (2 g/day) of alpha-linolenic acid on~          incidence of cardiovascular diseases.~   "
261443|NCT00127439|"~     The purpose of this study is to collect data comparing two means of providing locomotor~     training: manual and robotic and the possible differential effects it may have on walking~     ability for persons with spinal cord injury (SCI).~   "
261444|NCT00127413|"~     The purpose of this study is to examine the efficacy of an integrated treatment for Veterans~     with comorbid chronic pain and posttraumatic stress disorder (PTSD). It is hypothesized that~     Veterans who receive the integrated treatment will report more positive outcomes than~     individuals who are assigned to treatment as usual, pain treatment, or PTSD treatment.~   "
261445|NCT00127400|"~     The purpose of this study is to see how different forms of Anger Management compare in~     reducing anger and impulsive aggressive symptoms in people. Anger Management is a common~     form of talk therapy used to help people with anger problems. There are different types of~     talk therapy used to help people for anger problems and this study will compare two types~     of talk therapy in people with Intermittent Explosive Disorder (IED). IED is a disorder in~     which there are frequent and sudden outbursts of anger (yelling, throwing and breaking~     things, hitting people) that lead to problems with other people socially or at work.~   "
261446|NCT00127387|"~     Patients who receive radiation therapy often have fatigue or a decrease in feeling well~     causing a wasting away. For patients with advanced disease of lung cancer, prostate cancer,~     or cancer that has spread to the bone, it is hoped that this drug may decrease this. If~     patients feel better during treatments they can complete the therapy without any breaks in~     treatment. For treatment to be most effective, it should be given in the amount needed, on a~     particular schedule.~   "
261447|NCT00127374|"~     The specific aims of this study are to document the co-existence of depression, low~     self-esteem, and high-risk behaviors among overweight and at-risk for overweight female~     adolescents; and decrease the prevalence of high-risk behaviors by improving depressive~     symptoms/signs and self-esteem through weight management intervention strategies that~     encourage long-term mental and physical well being. The proposed research will test the~     following hypotheses:~        -  Overweight and at-risk for overweight female adolescents have poor self-esteem that may~          mask depression and mediate high-risk behaviors; and~        -  Improved weight perception decreases participation in high-risk behavior secondary to~          improved self-esteem and depression.~   "
261448|NCT00127361|"~     The purpose of this study was to compare labor outcomes in women accompanied by an additional~     support person (doula group) with outcomes in women who did not have this additional support~     person (control group).~      The current study was designed with the benefits of continuous labor support in mind as well~     as the need for a cost-effective, affordable program to provide those services for low-income~     women. Its purpose was to evaluate the effects of continuous labor support provided by a~     female companion of the pregnant person's choosing who, with the mother, had participated in~     an educational program to teach her how to provide continuous labor support.~   "
261449|NCT00127348|"~     The objective of the study is to evaluate the effect of CPAP over the incidence of~     cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea.~      The hypothesis of the study is the following: The existence of sleep disordered breathing in~     the general population is associated to an increased incidence of arterial hypertension and~     to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders~     during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime~     sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular~     complications.~      The end points of the study are new diagnosis of arterial hypertension and new cardiovascular~     events.~      All patients, after randomization, will be followed for three years.~   "
261450|NCT00127335|"~     There is a significant proportion of patients complaining of muscle symptoms while on statin~     therapy who have a measurable difference in muscle strength or endurance and whose muscle~     biopsies are diagnostic for myopathy.~   "
261468|NCT00127101|"~     This is an investigational study that increases the dosage to determine the~     safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with~     Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one~     prior systemic therapy.~   "
261469|NCT00127088|"~     This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical~     prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate~     and a risk of relapse after radical prostatectomy.~   "
261483|NCT00126906|"~     In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study~     was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen~     administered in the second and third trimester of pregnancy. In this investigation, this two~     dose strategy was compared to a monthly SP regimen. The objective for the study was to~     determine the efficacy of the different regimens for HIV positive and HIV negative women in~     the prevention of placental malaria.~   "
261451|NCT00127322|"~     Many people with heart failure either die or are admitted to the hospital in the first few~     months after the condition is diagnosed. The reasons for this are currently unclear- but may~     be due to worsening heart failure or other medical conditions such as angina, heart attack or~     sudden electrical problems of the heart. The investigators propose to recruit and follow-up~     450 people, with a new diagnosis of heart failure for a minimum of six months in a~     multi-centre observational study at two hospital sites: The Hillingdon (Uxbridge) and The~     Conquest (Hastings) hospitals. The total study duration will be two years. People will be~     recruited after a diagnosis of heart failure is made and the study will assess reasons for~     death or admission to hospital and the psychological impact of the condition on both patients~     and their carers. This is an observational study and no change will be made to patients’~     conventional treatment.~      Hypotheses:~        1. The high mortality and hospitalisation rate in the early period after diagnosis of heart~          failure is related to progressive pump failure; or~        2. The high mortality in the early period after the diagnosis of heart failure is related~          to co-morbid events- principally major coronary events such as myocardial infarction or~          acute coronary syndrome.~      This research should help to identify ways of improving the outlook for people with newly~     diagnosed heart failure. The analysis of the data generated by this study will be supervised~     by a statistician. Clinical and demographic data will be described using mean + standard~     deviation, for continuous variables, and absolute numbers and percentages for categorical~     variables. Group differences will be examined by t-tests for continuous variables and~     Chi-square (x2) test for categorical variables. Survival will be reported in terms of~     Kaplan-Meier curves with differences analysed by Cox proportional hazards.~   "
261452|NCT00127309|"~     Glutathione (a tripeptide of 3 amino acids - glutamic acid, cysteine and glycine) plays a~     great role in homeostasis, especially as a potent anti-oxidant.~      As an anti-oxidant, it conjugates with xenobiotics using glutathione-S-transferase (GST) and~     excretes in urine as mercapturic acid.~      In 1986, Casciani et al at the University of Milan, studied the effect of glutathione on~     blood alcohol, acetaldehyde and hepatic triglyceride levels and found a significant reducing~     effect.~      The blood acetaldehyde, which is the metabolic product of ethyl alcohol may have a~     correlation with hangover symptoms. This study is designed to find this correlation using~     blood alcohol, blood acetaldehyde levels and the Hangover Symptoms Scale according to the~     Slutske et al study.~   "
261453|NCT00127296|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix~     70/30 FlexPen® and vial and syringe in subjects with type 2 diabetes mellitus. No insulin is~     administered in this trial - insulin is dispensed into an empty vial.~   "
261454|NCT00127283|"~     This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South~     America.~      The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog~     alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more~     patients will recover without severe permanent disability after acute treatment with~     Recombinant Factor VIIa by reducing further intracerebral bleeding.~   "
261455|NCT00127270|"~     This study is designed to investigate the efficacy and safety of treatment of overactive~     bladder with darifenacin administered alone or in conjunction with behavioral modification~     therapies.~   "
261456|NCT00127257|"~     Constipation affects 4% of adults in the United States (U.S.). An estimated half of~     constipated patients are unable to relax pelvic floor muscles during defecation, a type of~     constipation called pelvic floor dyssynergia (PFD). Biofeedback has been recommended for the~     treatment of constipation because uncontrolled studies over the past 10 years suggest that~     these treatments are as effective as medical or surgical management and involve no risk.~     However, placebo-controlled trials are still lacking. The aims of this study are:~        -  to compare biofeedback to alternative therapies for which patients have a similar~          expectation of benefit;~        -  to identify which patients are most likely to benefit; and~        -  to assess the impact of treatment on quality of life.~   "
261457|NCT00127244|"~     The purposes of this study are to:~        1. compare the clinical effectiveness of a traditional and a medical model of periodontal~          therapy; and~        2. determine the value of the two approaches to periodontal therapy.~   "
261458|NCT00127231|"~     The purpose of this study is to determine whether two brief counseling sessions reduce~     drinking and improve health outcomes in HIV-positive women who drink at heavy/hazardous~     levels. Also, the study seeks to compare hazardous drinking versus nonhazardous drinking~     women on a variety of alcohol, HIV and life quality outcome measures.~   "
261459|NCT00127218|"~     The purpose of this study is to investigate the added benefits of increased high-density~     lipoprotein (HDL) cholesterol serum levels over and above those achieved by lipid lowering~     therapy guided by current guidelines, in older individuals with cardiovascular disease.~   "
261460|NCT00127205|"~     RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in~     patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more~     effective than clodronate or ibandronate in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works~     compared to clodronate or ibandronate in treating women who have undergone surgery for stage~     I, stage II, or stage III breast cancer.~   "
261461|NCT00127192|"~     The purpose of this trial is to determine the efficacy and safety of an investigational drug~     in patients with type 2 diabetes mellitus.~   "
261462|NCT00127179|"~     The purpose of this trial is to determine the efficacy and safety of an investigational drug~     in patients with benign prostatic hyperplasia.~   "
261463|NCT00127166|"~     The purpose of this study is to determine the effect of four weeks of treatment with two~     investigational drugs (oral versus inhaled administration) plus an inhaled medication in the~     treatment of airway constriction brought on by exercise in participants with asthma.~   "
261464|NCT00127153|"~     The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an~     investigational pneumococcal vaccine in healthy adults.~   "
261465|NCT00127140|"~     The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the~     maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral~     vorinostat in patients with malignant lymphoma.~   "
261466|NCT00127127|"~     The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the~     maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral~     suberoylanilide hydroxamic acid in patients with solid tumors.~   "
261467|NCT00127114|"~     The purpose of this clinical trial is to test whether or not the medication amantadine is~     effective in reducing behavioral disturbances in patients with frontotemporal dementia.~   "
261484|NCT00126893|"~     This is a single center Phase 1 study to evaluate the safety, pharmacokinetics and~     pharmacodynamics of CC-401 in subjects with refractory acute myelogenous leukemia.~   "
261470|NCT00127075|"~     Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their~     childbearing years. It is an autoimmune disease of the central nervous system (CNS), which~     results in a chronic focal inflammatory response with subsequent demyelination and axonal~     loss. Recent prospective studies reported a significant decline by two-thirds in the rate of~     relapses during the third trimester of pregnancy and a significant increase by two-thirds~     during the first three months post-partum by comparison to the relapse rate observed during~     the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the~     relapse rate occur at a time when the impregnation of many substances (among which, sexual~     steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels,~     immediately following delivery.~      It may be hypothesized that sexual steroids could exert beneficial effects through a~     modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses~     of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They~     may also play a direct role in the remyelination of central nervous system lesions, as they~     do in the peripheral nervous system. The POPART'MUS study is a European, multicentre,~     randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS~     relapses related to the post-partum condition, by administering high doses of progestin~     (nomegestrol acetate), in combination with endometrial protective doses of estradiol.~     Treatment will be given immediately after delivery and continuously during the first three~     months post-partum. Assuming the results of the trial to be positive, this new treatment~     could be considered in the relapsing-remitting phase of the disease in women afar from~     pregnancy and post-partum.~   "
261471|NCT00127062|"~     Acute exposure to diesel exhaust under normal city conditions leads to a worsening of~     symptoms of asthma, with reduction in lung function in asthmatic nonsmoking adults, dependent~     on the exposure dose and on the background severity of asthma.~      The worsening asthma is accompanied by increased oxidative stress and inflammation in the~     lungs.~   "
261472|NCT00127049|"~     This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide~     (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted~     favorable prognosis.~   "
261473|NCT00127036|"~     The purpose of this study is to determine if the investigators can predict the sensitivity or~     resistance of colon cancer to the two available first line chemotherapy agents.~   "
261474|NCT00127023|"~     This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK)~     Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy~     children in their second year of life.~   "
261475|NCT00127010|"~     This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK)~     Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy~     children in their second year of life.~   "
261476|NCT00126997|"~     This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals~     live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their~     second year of life.~   "
261477|NCT00126984|"~     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one~     dose of four different formulations of the MenACWY conjugate vaccine when given to healthy~     children aged 12 14 months and 3 5 years. The selection of the best formulation will be based~     on data obtained up to one month after the vaccine dose. The Protocol Posting has been~     updated in order to comply with the FDA Amendment Act, September 2007.~   "
261478|NCT00126971|"~     Controlling malaria during pregnancy is a vital strategy in decreasing maternal and child~     mortality in Africa. There are data from clinical trials and program evaluations in stable~     transmission areas that show that intermittent preventive treatment (IPT) with two doses of~     sulfadoxine-pyrimethamine (SP) is safe, efficacious, and effective in preventing maternal~     anemia, placental parasitemia, and low birth weight (LBW). SP is also the first-line drug for~     the case-management of malaria in pregnancy. Resistance to SP, however, is increasing rapidly~     in East and Central Africa and compliance to the rescue treatment, 7-days of oral quinine, is~     low. There is an urgent need to find effective, safe and practical alternative drugs for the~     treatment of malaria in pregnancy. The synergistic antifolate combination~     chlorproguanil-dapsone (CD), has recently become available. It is inexpensive, well~     tolerated, is given as single daily treatment doses for 3 days, and is effective in the~     treatment of drug-resistant falciparum malaria.~      The investigators propose a small pharmacokinetic study of CD to determine if current fixed~     combination CD tablets provide an adequate dosage in pregnancy. Such a study is a necessary~     precursor to any large Phase II trials to further evaluate the safety and efficacy of CD for~     use in pregnant women. To accomplish this, a group of 66 parasitemic pregnant women in this~     open label trial will receive CD and be sampled by venipuncture at two of the seven follow-up~     visits scheduled for pharmacokinetic analyses, such that 11 patients are sampled at each of~     12 time points. To serve as a reference, 66 non-pregnant women with symptomatic malaria will~     also be treated with CD and will have identical pharmacokinetic (PK) analyses performed.~      Pregnant women greater than or equal to 20 weeks gestation with P. falciparum parasitemia on~     peripheral blood film will be given an insecticide-treated net (ITN) and will receive CD (1.5~     or 2 tablets daily for 3 days, depending on weight). All study drug dosing will be observed.~     Women will be examined, adverse events recorded, and blood samples collected at days 0, 1, 2,~     3, 7, 14, 21, and 28 after treatment, and thereafter every 14 days until delivery. Women will~     be further randomized to receive additional blood draws for pharmacokinetic analyses using a~     modified rich PK schedule. Each woman will only have 2 additional blood draws. Women at~     delivery will have peripheral and placental blood films prepared. Newborns will be weighed,~     examined, and gestational age determined. Women requiring antimalarial treatment for~     parasitemia at any point between enrollment and delivery will be treated with quinine.~     Adverse effects will be assessed at each scheduled visit, any sick visits during the study,~     and at delivery.~   "
261479|NCT00126958|"~     This randomized clinical multicentre trial aims to evaluate the efficacy of microsatellite~     analysis on voided urine to detect tumour recurrences in the follow-up of patients with~     superficial urothelialcell carcinoma (UCC). Further, this study aims to identify subgroups of~     patients with a low risk of tumour recurrence using clinico-pathologic tumour characteristics~     in combination with a genetic marker (FGFR3 gene), such that the frequency of follow-up~     contact can be reduced. The overall objective is to reduce the frequency of cystoscopy during~     follow-up in patients with superficial UCC, leading to an improvement in quality of life at~     equal or lower costs. This study evaluates the cost-effectiveness of follow-up in bladder~     cancer.~   "
261480|NCT00126945|"~     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one~     dose of four different formulations of the MenACWY conjugate vaccine when given to healthy~     subjects aged 15-19 years. The selection of the best formulation will be based on data~     obtained up to one month after the vaccine dose.~   "
261481|NCT00126932|"~     Children ages 3-7 who are undergoing blood drawing receive either standard care, topical~     medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the~     onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure~     is evaluated.~   "
270880|NCT00042133|"~     The overall goal of the proposed project is to examine the reasons for the higher levels of~     disability in older people of lower socio-economic status.~   "
261486|NCT00126867|"~     Cancers of the colon and rectum are the third most common cancers in Canadian males and~     females. The initial therapy of colorectal cancer is surgery to remove the cancer and nearby~     lymph glands. If the cancer has spread to the lymph glands there is a high chance that the~     cancer will come back. To reduce the risk of the cancer recurring, patients are treated with~     an anticancer drug capecitabine. This study will determine if a simple blood test can predict~     which patients are at risk for developing side effects from this chemotherapy. In addition,~     participants of this study will be followed to determine if this same blood test will predict~     which patients will have their cancer relapse.~   "
261487|NCT00126854|"~     The purpose of this study is to establish the correct scanning parameters for obtaining good~     quality 3 Tesla (3T) magnetic resonance spectroscopy images (MRSI) of the prostate gland~     before and after brachytherapy implantation for prostate cancer. Three Tesla MRSI may be a~     valuable additional diagnostic and follow-up investigation for prostate cancer patients.~   "
261488|NCT00126841|"~     Patients with more advanced stages of cervix cancer are treated by radiotherapy. Overall,~     more than 50% are cured. Approximately half of those patients not cured have current cancer~     in the irradiated volume. Higher doses of radiation would be expected to cure more patients.~     To give high doses of radiation safely, the investigators need to know very precisely where~     the cancer is and then they can use new technology available at the Cross Cancer Institute~     (tomotherapy) to target the cancer precisely, giving higher doses to the cancerous tissues~     and lower doses to the non-cancerous tissues.~      This study of ten patients with cervical cancer will investigate the added value of MRI~     scanning on precise tumor definition to facilitate more accurate radiotherapy treatment~     planning. For this study, patients will be treated in the conventional way with conventional~     doses. The investigators hope that treatment for future patients will be planned with MRI~     data and that they will be treated to higher doses of tomotherapy.~   "
261489|NCT00126828|"~     Patients who have limited stage small cell lung cancer are presently treated with~     chemotherapy and radiation therapy (RT). Despite this aggressive treatment the vast majority~     of patients will have their cancer recur after treatment. A recurrence is not curable at this~     time, therefore efforts to reduce recurrence rates are desirable. Due to the sensitivity of~     surrounding structures in the chest to radiation, it has not been possible to give doses that~     can cure most tumours. Three-dimensional conformal radiotherapy is a special form of~     radiation therapy that allows doctors to reduce the amount of radiation dose to normal~     tissues and therefore reduce toxicity and in turn, let them safely increase the dose to~     tumours. The purpose of this study is to determine whether the combination of~     three-dimensional conformal radiotherapy and chemotherapy will be a more effective treatment.~     If the treatment is found to be safe for the first group of patients, then the total~     radiation dose will be increased for the next group of patients who are treated on this~     study.~   "
261490|NCT00126815|"~     Clinical data are being used to build a mathematical model to describe the clinical results~     of radiotherapy for prostate cancer.~   "
261491|NCT00126802|"~     Helical tomotherapy is being used to treat the prostate gland, local rates of spread and~     regional lymph nodes whilst sparing gross structures. The radiation to the gross disease in~     the prostate is hypofractionated and dose escalated. Magnetic resonance spectroscopic imaging~     (MRSI) is incorporated into pre- and post-treatment evaluation.~   "
261492|NCT00126789|"~     The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in~     providing relief of cancer pain.~   "
261493|NCT00126776|"~     The purpose of this study is to determine if a program of self management and case management~     reduces hospitalizations and urgent care visits for patients with chronic obstructive~     pulmonary disease (COPD).~   "
261494|NCT00126763|"~     The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in~     providing relief of non-malignant chronic pain.~   "
261495|NCT00126750|"~     To assist busy primary care clinicians in VA Community Based Outpatient Clinics (CBOCs) in~     managing complex patients by providing a single, interactive, and personalized source of~     information regarding applicable guidelines for post-MI patients. Specifically, 1) the~     investigators will identify barriers to provider adherence to guidelines within VHA clinics;~     2) Apply guideline-based performance measures to electronic medical records (CPRS) and~     associated administrative data; 3) Implement the interactive Internet intervention developed~     by the NHLBI study, after inclusion of VA-specific components, including performance feedback~     for CBOC clinicians; and 4) Test hypotheses on the intervention's effectiveness,~     sustainability, and cost-effectiveness in both the VA and Medicare populations. This will~     include a randomized controlled trial with the CBOC as a unit of randomization.~   "
261496|NCT00126737|"~     The purpose of this study is to determine whether a home-based exercise and weight control~     program applied to elderly overweight individuals with painful osteoarthritis of the knee,~     would result in pain reduction.~   "
261497|NCT00126724|"~     The 13G01 clinical trial is a Phase I/II dose escalation study designed to be conducted in~     adults with inflammatory arthritis who have persistent moderate or severe swelling in one or~     more joints, without a disease severe enough to warrant a change in regimen for the next~     three months.~      The study will permit subjects who are concurrently on anti-tumor necrosis factor (TNF)-alpha~     antagonists. For subjects on disease modifying antirheumatic drugs (DMARDs), a stable regimen~     for inflammatory arthritis for the previous three months, with no changes in doses in the~     four weeks prior to screening will be required.~      The primary objectives are:~        1. to evaluate the safety of intra-articular administration of tgAAC94 in subjects~          currently taking TNF-alpha antagonists, and~        2. to evaluate the safety of repeat intra-articular administration of tgAAC94 (gene therapy~          vector).~   "
261498|NCT00126698|"~     Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of~     all). The purpose of this study is to determine whether antibiotic prophylaxis for urinary~     catheter removal is useful at preventing catheter-associated urinary-tract infection.~   "
261499|NCT00126685|"~     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body~     build an effective immune response to kill tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects of vaccine therapy and to see how~     well it works in treating patients with stage IV melanoma.~   "
261501|NCT00126659|"~     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. Giving sorafenib before and after surgery may~     be an effective treatment for kidney cancer. This phase II trial is studying how well~     sorafenib works in treating patients who are undergoing surgery for metastatic kidney cancer.~   "
261502|NCT00126646|"~     RATIONALE: BL22 immunotoxin can find tumor cells and kill them without harming normal cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in~     treating patients with refractory B-cell chronic lymphocytic leukemia, prolymphocytic~     leukemia, or non-Hodgkin's lymphoma.~   "
261503|NCT00126633|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and cisplatin~     together with bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together~     with bevacizumab works in treating patients with metastatic pancreatic cancer.~   "
261504|NCT00126620|"~     RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking blood flow~     to the tumor and by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib and~     erlotinib in treating patients with metastatic or unresectable solid tumors.~   "
261505|NCT00126607|"~     This phase II trial is studying how well trastuzumab works in treating patients with~     metastatic or recurrent salivary gland cancer. Monoclonal antibodies, such as trastuzumab,~     can block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them~   "
261506|NCT00126594|"~     This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well~     they work compared to sorafenib alone in treating patients with metastatic kidney cancer.~     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and~     interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with~     interferon alfa-2b may kill more tumor cells.~   "
261507|NCT00126581|"~     This randomized phase II trial studies how well erlotinib hydrochloride with or without~     carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung~     cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib~     hydrochloride together with carboplatin and paclitaxel may kill more tumor cells.~   "
261508|NCT00126568|"~     This phase II trial is studying how well sorafenib works in treating patients with advanced~     anaplastic thyroid cancer. Sorafenib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
261509|NCT00126555|"~     The goal of this clinical research study is to learn if giving Iressa (Gefitinib or ZD1839)~     with surgery and/or radiation will help to control squamous cell carcinoma of the skin. The~     safety of this treatment will also be studied~   "
261510|NCT00126542|"~     This phase II trial is studying how well giving bevacizumab together with erlotinib works in~     treating patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary~     peritoneal cavity cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may~     also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     bevacizumab together with erlotinib may kill more tumor cells.~   "
261511|NCT00126516|"~     The purpose of this study is to elucidate whether or not angiotensin II receptor blockers~     (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on~     development or progression of silent brain infarction and cognitive decline in Japanese~     patients with essential hypertension in the elderly.~   "
261512|NCT00126503|"~     This phase I/II trial studies the side effects and best dose of sorafenib tosylate and~     bevacizumab and to see how well they work in treating patients with advanced kidney cancer.~     Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth by~     targeting certain cells. Bevacizumab and sorafenib tosylate may also stop the growth of tumor~     cells by blocking blood flow to the tumor. Giving sorafenib tosylate together with~     bevacizumab may kill more tumor cells.~   "
261513|NCT00126490|"~     This phase II trial is studying how well giving bevacizumab together with interleukin-2 works~     in treating patients with metastatic kidney cancer. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood~     flow to the tumor. Interleukin-2 may stimulate the white blood cells to kill tumor cells.~     Giving bevacizumab together with interleukin-2 may kill more tumor cells.~   "
261514|NCT00126477|"~     RATIONALE: Studying quality of life in cancer survivors may help determine the long-term~     effects of hematologic cancer and may help improve the quality of life for future cancer~     survivors.~      PURPOSE: This clinical trial is studying the quality of life of adult cancer survivors who~     have undergone a previous bone marrow or peripheral stem cell transplant for a childhood~     hematologic cancer.~   "
261532|NCT00126243|"~     Most treatment procedures in AIDS-related lymphomas disclose a relatively poor outcome for~     patients with low response rates, high number of relapses and AIDS events. The addition of~     rituximab to the standard regimen - CHOP could improve the outcome of these patients. The aim~     of the trial is to evaluate the safety and efficacy of rituximab when added to the CHOP~     regimen in patients with newly diagnosed AIDS-related non-Hodgkin lymphoma.~   "
261515|NCT00126464|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor~     cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for~     breast cancer.~      PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen~     works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in~     situ of the breast.~   "
261516|NCT00126451|"~     This is an investigational study to determine the response rate of relapsed/refractory~     breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid~     (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response~     evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and~     tolerability of oral suberoylanilide hydroxamic acid.~   "
261517|NCT00126438|"~     The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to~     predict cardiac outcome in subjects with heart failure and in comparison to subjects without~     cardiovascular disease.~   "
261518|NCT00126425|"~     The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to~     predict cardiac outcomes in subjects with heart failure and in comparison to subjects without~     cardiovascular disease.~   "
261519|NCT00126412|"~     The study is designed to study the effectiveness of 123I-mIBG as a diagnostic imaging agent~     in evaluating patients with known or suspected neuroblastoma or phaeochromocytoma.~   "
261520|NCT00126399|"~     The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline~     controlled-release capsules administered once daily for the treatment of rosacea compared~     with a placebo.~   "
261521|NCT00126386|"~     Treatment in the home and hospice of long-term care facilities, particularly for~     non-ambulatory patients, could provide significant advantages for patients and for the~     region. The Calgary Health Region has a unique resource in the home parenteral therapy~     program (HPTP). With the assistance of HPTP, patients requiring bisphosphonate treatment for~     the management of tumor-induced hypercalcemia (TIH) or malignant bone pain (MBP) could be~     treated in the community (ie at home). However, the resources required and the costs~     associated with community-based (homes, hospices, long-term care facilities) treatment of TIH~     and MBP need to be identified and evaluated so as to guide future regional decision making.~   "
261522|NCT00126373|"~     The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical~     remission in Crohn's disease.~   "
261523|NCT00126360|"~     This is a randomized study comparing the use of Anastrozole before and continuing during~     radiotherapy for breast cancer compared to the use of anastrozole after irradiation.~   "
261524|NCT00126347|"~     The purpose of this study is to determine whether reducing the increase in plasma~     homocysteine concentrations following an oral methionine load affects vascular function in~     healthy volunteers, irrespective of the homocysteine-lowering agent.~   "
261525|NCT00126334|"~     The purpose of this trial is to determine whether a conservative or a liberal blood~     transfusion strategy is better for patients with a heart attack and a low blood count.~   "
261526|NCT00126321|"~     The purpose of this study is to evaluate the safety and the efficacy of cladribine, high-dose~     cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia.~   "
261527|NCT00126308|"~     This is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and~     extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced~     facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep~     subcutaneous injections of poly-L-lactic acid (PLA). Subjects will receive 4 treatments of~     PLA approximately every 2nd week, either at trial entry or following a delay period of 24~     weeks.~   "
261528|NCT00126295|"~     The primary aim of the randomised controlled trial was to evaluate the effectiveness of a~     tailored written education package (“What you need to know about stroke) on the outcomes of:~        -  Knowledge about stroke, self-efficacy, anxiety, depression, perceived health status,~          satisfaction with the content and presentation of the information received, and desire~          for additional information for patients following stroke and~        -  Knowledge about stroke, self-efficacy, anxiety, depression, satisfaction with the~          content and presentation of the information received, and desire for additional~          information for their carers.~      A secondary aim was to evaluate the effect of written information on the outcomes of~     knowledge about stroke, self-efficacy, anxiety, depression, and perceived health status of~     patients following stroke and on knowledge about stroke, self-efficacy, anxiety, and~     depression of their carers.~   "
261529|NCT00126282|"~     This study examines the efficacy of the medication D-Cycloserine in the reduction of~     obsessions and compulsions in individuals with obsessive-compulsive disorder (OCD). All study~     participants will receive Exposure and Response Prevention, a common form of behavior therapy~     for individuals with OCD. Half (50%) of the participants will be randomly assigned to the~     placebo condition and the other half (50%) will be randomly assigned to receive~     D-Cycloserine. Because all participants will receive 10 sessions of behavior therapy, all~     participants are expected to improve from this treatment.~   "
261530|NCT00126269|"~     This is a randomized phase III trial comparing cisplatin with or without gemcitabine in~     patients with carcinoma of unknown primary and a predicted favorable prognosis.~      The purpose of this trial is to compare the overall survival rates of patients with carcinoma~     of unknown primary (CUP) and a predicted favorable prognosis according to the French~     classification treated with cisplatin with or without gemcitabine.~   "
261531|NCT00126256|"~     The standard treatment of metastatic colorectal cancer is based on systemic chemotherapy.~     Several effective drugs are currently available and can be administered either sequentially~     or in combination. Most patients receive 2 or 3 lines of chemotherapy. The aim of this~     randomized trial is to evaluate the potential benefit of a bitherapy with 5-fluorouracil~     (5-FU) and oxaliplatin as first line chemotherapy compared with a sequential chemotherapy~     with 5-FU alone as first line chemotherapy followed by the combination of 5-FU with~     oxaliplatin in case of progressive disease, in terms of progression-free survival and overall~     survival in patients with advanced colorectal cancer.~   "
261533|NCT00126230|"~     This is a prospective phase II trial of docetaxel-samarium in patients with~     hormone-refractory advanced prostate cancer who achieve a response or a stabilization to~     docetaxel-estramustine.~   "
261534|NCT00126217|"~     BCG has marked immune stimulatory effects in both animal and human studies and observational~     studies suggest that BCG is associated with a non-specific reduction in mortality in areas~     with high infant and child mortality. The specific objective of the study is to examine the~     effect of revaccination for purified protein derivative of tuberculin (PPD) reaction, scar~     size, morbidity and mortality in a randomised prospective study of revaccination versus no~     revaccination among children 19 months of age in Guinea-Bissau. The hypothesis is that~     revaccination with BCG reduces childhood mortality after 19 months of age by 30%.~   "
261535|NCT00126204|"~     The durability of endovascular aneurysm repair (EVAR) has been limited by development of~     endoleaks which may be secondary to progressive aortic degeneration by matrix~     metalloproteases (MMP). Doxycycline is a known inhibitor of the MMP family of enzymes in~     aneurysms. The investigators propose a randomized, controlled trial of adjuvant doxycycline~     therapy with EVAR to determine its effects on re-intervention, aneurysm shrinkage and serum~     markers of aneurysmal degeneration.~   "
261536|NCT00126191|"~     The purpose of this study is to learn more about how well a chemotherapy regime including~     rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma.~   "
261537|NCT00126178|"~     This is an international, open label, randomized phase 3 trial in which patients with~     surgically removable kidney cancer will be randomly selected post-operatively to receive~     adjuvant treatment with autologous HSPPC-96 or no adjuvant treatment. All patients will~     undergo complete surgical removal of their tumors.~   "
261538|NCT00126165|"~     This study is aimed at providing further clinical evidence to support or refute the current~     understanding of biological sensitivity of prostate cancer to fractionated radiotherapy.~     Determining the morbidity and cancer control provided by a 4-week course of treatment will~     greatly influence future radiotherapy services for patients with localized prostate cancer.~   "
261539|NCT00126152|"~     The purpose of this study is to evaluate the effectiveness of a best practice model for~     senior falls prevention when implemented in a community setting.~   "
261540|NCT00126139|"~     The purpose of the present prospective, randomized, double-blind, double dummy controlled~     multicenter pilot study is to investigate whether abciximab, compared with aspirin, is able~     to reduce the rate of recurrent ischemic strokes before and during carotid endarterectomy~     [CEA] (primary endpoints); and the degree of carotid stenosis, number of microembolic signal~     (MES) counts, number of ischemic infarcts at diffusion weighted imaging (DWI) and amount of~     intraluminal thrombus at pathological examination (secondary endpoints) in patients with~     ischemic stroke due to a >50% carotid stenosis who will undergo CEA.~   "
261541|NCT00126126|"~     The purpose of this study is to determine if an evidence based exercise intervention improves~     the functional mobility of diabetic amputees (single lower leg amputation) who have already~     completed standard rehabilitation and prosthetic training.~   "
261542|NCT00126113|"~     The purpose of the study is to determine whether a new test of ability to understand speech~     in noise and an associated counseling program can improve hearing aid satisfaction.~     Participants complete routine hearing tests, some hearing-related questionnaires and the new~     speech test. One group of participants receives the new form of counseling, the second group~     does not. Hearing aid satisfaction following 10 weeks hearing aid use is compared across the~     groups.~   "
261543|NCT00126100|"~     The purpose of this study is to determine whether stem cell mobilization by granulocyte~     colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after~     successful mechanical reperfusion reduces infarct size.~   "
261544|NCT00126087|"~     The investigators plan to improve the learning of motor skills by pharmacological means~     (dopamine), and by noninvasive brain stimulation. They will study both healthy subjects and~     chronic stroke patients. In addition, they want to study the mechanisms of enhanced learning,~     on the molecular and the systems level.~   "
261545|NCT00126074|"~     The purpose of this study is to demonstrate the ability of tedisamil to convert atrial~     fibrillation or flutter into normal sinus rhythm (NSR) in female patients.~   "
261546|NCT00126061|"~     The purpose of this study is to demonstrate the ability of tedisamil to convert atrial~     fibrillation or flutter into normal sinus rhythm (NSR) in male patients.~   "
261547|NCT00126048|"~     Statins are the most common type of cholesterol-lowering drugs used in clinical practice.~     Recent research suggests that they may also have anti-inflammatory properties, in particular~     by inhibition of an important inflammatory cell called a T lymphocyte. Asthma is~     characterised by chronic inflammation in the airways, which is thought to be regulated by the~     activity of T lymphocytes. The investigators have found the anti-inflammatory activity of a~     statin drug in an experimental model of allergic asthma and they have recently shown the~     beneficial effects of a statin, atorvastatin, in patients with rheumatoid arthritis. These~     findings demonstrate the therapeutic potential of statin-sensitive pathways in allergic~     airways disease. The investigators plan to perform a proof of concept study to determine~     the effectiveness of statin therapy in asthma. This randomised controlled trial will test the~     hypothesis that statins improve asthma control of patients with chronic asthma. The study~     will be a 22-week randomised controlled trial comparing the effect on asthma control of oral~     atorvastatin with that of a matched placebo. Each treatment will be administered for 8 weeks~     separated by a 6-week washout period. A total of 52 allergic asthmatic patients will be~     recruited to ensure that 44 patients complete the study. The investigators will examine the~     effect of statin therapy on lung function, symptom scores, exacerbation rates, as well as on~     the measurement of airway inflammation in sputum and in the blood. This study will determine~     the benefit of atorvastatin as an add-on therapy in asthma and establish if statins might~     have a role in asthma management.~   "
261548|NCT00126035|"~     The purpose of the study was to assess the efficacy of Migraid in terms of preventing~     headaches in patients with migraine with typical aura. The secondary objectives were to~     assess whether Migraid is able to achieve pain relief and/or relief of migraine associated~     symptoms and to evaluate the safety and tolerability of the study treatment.~   "
261549|NCT00126022|"~     The purpose of this study is to demonstrate the ability of tedisamil to convert atrial~     fibrillation or flutter into normal sinus rhythm (NSR) in female patients.~   "
261602|NCT00125333|"~     The purpose of this study is to determine whether this topical NF-kappaB Decoy candidate is~     safe in persons with atopic dermatitis. Preliminary evidence of efficacy (whether it is~     working) will also be evaluated.~   "
261550|NCT00126009|"~     The primary objective is:~        -  To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to~          the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering~          from a manic episode according to DSM IV TR (American Psychiatric Association [APA]~          2000) and treated for a 3-month period.~      The secondary objectives are:~        -  To evaluate the clinical and biological safety of the association valproate-amisulpride~          to the association valproate-haloperidol;~        -  To assess the patient status 3 weeks and 3 months after inclusion; and~        -  To assess patient satisfaction at 3 months.~   "
261551|NCT00125996|"~     This is a two-center, randomised, single-blind (physician), prospective, controlled study to~     assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose~     supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure~     (CHF).~      The hypotheses are:~        -  Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose~          improves exercise capacity as measured by peak VO2.~        -  IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.~   "
261552|NCT00125983|"~     The purpose of this study is to examine the drug interactions between a protease inhibitor~     (PI)-based regimen including lopinavir/ritonavir (LPV/r) and two forms of contraceptive~     medications in HIV infected women.~   "
261553|NCT00125970|"~     The purpose of the study is to determine the safety of and immune response to a DNA HIV~     vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.~   "
261554|NCT00125957|"~     Many people with depression are treated with a serotonin-specific reuptake inhibitor~     anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not~     feel completely 'well'. Often, individuals continue to complain of cognitive problems such as~     lack of attention, diminished motivation, and impaired problem-solving. This study looks at~     whether residual and cognitive symptoms of depression in individuals are affected by the~     addition of Wellbutrin (bupropion).~   "
261555|NCT00125944|"~     The objective is to assess the safety of bivalent vaccine of two new 6:2 influenza virus~     reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist)~     containing them.~   "
261556|NCT00125931|"~     The opiate neurotransmitter system is thought to be involved in many abnormal mood states.~     Some researchers have suggested that changes in this system may trigger the switch to/from~     manic and depressive states in bipolar disorder. One problem with most of the currently~     available opiate medications is that they can produce addiction/dependence. A particular kind~     of opiate medication known as kappa-opiates may be able to produce changes in this system~     with much less risk of addiction. This study looks at Talwin (a combination of pentazocine~     and naloxone), a medication which affects the kappa and mu opiate systems. The study will~     examine whether two doses of Talwin affect manic symptoms in people who have been admitted to~     the hospital. This study will give more information about the involvement of the opiate~     system in bipolar disorder, and give important information for use in developing new~     treatments.~   "
261557|NCT00125918|"~     The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the~     treatment of pulmonary arterial hypertension.~   "
261558|NCT00125905|"~     Primary care centers can play a very important role in helping people to stop smoking. There~     is a large body of research on the effectiveness of specific interventions especially~     addressed to people who want to stop smoking. In addition to that, there are no studies with~     a large sample of individuals included that tested the complete range of interventions~     recommended nowadays for helping people in the different smoking cessation stages of change~     and with different degrees of physical and psychological dependence, especially including~     motivational interviewing in those not interested in cessation in the very next weeks. This~     study will test a complex intervention that at first classifies smokers in stages and after~     that treats every smoker according to what stage he/she is in at the moment, his/her degree~     of dependence and his/her own characteristics.~   "
261559|NCT00125892|"~     This study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome~     patients.~   "
261560|NCT00125879|"~     Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The overall objective of this study is to evaluate the long-term safety and~     efficacy of Myozyme treatment in patients with infantile-onset Pompe disease.~   "
261561|NCT00125866|"~     The purpose of this study is to compare the effects on blood pressure of a daily intake of a~     flavonoid-rich cocoa drink with that of the same drink from which the flavonoids have been~     largely extracted.~   "
261562|NCT00125853|"~     The purpose of this study is to conduct a randomised trial to compare the insulin~     sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a~     thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.~   "
261563|NCT00125840|"~     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the~     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia~     (ALL) who have had at least 2 prior treatment regimens.~      This research study of clofarabine will be used for advanced cancer in persons in which drugs~     are no longer effective or no reliable effective treatment is available. The purpose of this~     study is to find the answers to the following research questions:~        1. What is the largest dose of clofarabine that can be safely administered as an IV~          infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by~          1 week of rest and repeated every 28 days?~        2. What are the side effects of clofarabine when given on this schedule?~        3. How much clofarabine is in the blood at specific times after administration and how does~          the body get rid of the drug? Once the MTD/RP2D is established, patients will be~          enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every~          other cycle.~        4. Will clofarabine help treat a specific cancer?~   "
261603|NCT00125320|"~     The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to~     placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular~     and/or coronary artery bypass graft surgery.~   "
261564|NCT00125827|"~     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the~     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia~     (ALL) who have had at least 2 prior treatment regimens.~      This is a research study of clofarabine that will be given to patients (orally) with advanced~     cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer~     effective or no reliable effective treatment is available.~      The purpose of this study is to find the answers to the following research questions:~        1. What is the largest dose of oral clofarabine that can be safely given daily for 5 days~          followed by 23 days of rest and repeated every 28 days?~        2. What are the side effects of clofarabine when given on this schedule?~        3. How much oral clofarabine is in the blood at specific times after administration and how~          does the body get rid of the drug?~        4. Will oral clofarabine help treat solid tumor cancer?~   "
261565|NCT00125814|"~     The purpose of this study is to determine whether the adjunctional of interferon alfa to~     structured treatment interruptions correlated with a long time off treatment in HIV-1~     infection.~   "
261566|NCT00125801|"~     The purpose of this study is to see whether injection of hydromorphone through a subcutaneous~     injection device is more effective in treating breakthrough cancer pain than oral morphine.~   "
261567|NCT00125788|"~     The purpose of this research is to evaluate the effects of L-glutamine as a therapy for~     sickle cell anemia and sickle ß0-thalassemia. as evaluated by the number of occurrences of~     sickle cell crises.~   "
261568|NCT00125775|"~     Hepatitis B virus causes inflammation of the liver which is detrimental to the end-stage~     renal disease patients on dialysis. Hepatitis B vaccine is recommended for this high-risk~     population although the vaccine protection remains suboptimal and does not last long.~      The purpose of this study is to determine the best vaccination strategy over a 6-month period~     using recombinant hepatitis B vaccine (Engerix-B) in peritoneal dialysis patients. Current~     data show that the traditional Engerix-B vaccine dose (40 micrograms) does not always lead to~     protective and long-lasting hepatitis B surface antibody. The investigators, therefore,~     decided to compare the usual 40-micrograms with an 80-microgram dose strategy of vaccine~     protection.~   "
261569|NCT00125762|"~     This study will examine the effectiveness of the FibroScan device in differentiating fibrosis~     in patients with hepatitis B and C. The FibroScan measures liver stiffness and will be~     correlated to the liver biopsy to see if it can diagnose the stage of liver disease. Patients~     who are scheduled to have a liver biopsy will also have a fibroscan and the stiffness will be~     correlated with the biopsy stage.~   "
261570|NCT00125749|"~     The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with~     Stage IV melanoma.~   "
261571|NCT00125736|"~     The purpose of this study is to investigate the efficacy and safety of combination use of~     E0671 and Rabeprazole Sodium in patients with gastric ulcer.~   "
261572|NCT00125723|"~     The purpose of the study is to assess the impact of first and subsequent cycle pegfilgrastim~     on neutropenia events (such as hospitalizations, dose reductions and delays) in patients~     receiving myelosuppressive chemotherapy.~   "
261573|NCT00125710|"~     The treatment for patients with malignant brain tumors is disappointing. The disease is~     incurable and virtually all patients die from their disease. Despite the devastating nature~     of this illness which affects all age groups, its cause remains unexplained. Family~     identification with careful clinical and molecular study have led to the discovery of the~     genes that cause a number of other devastating diseases like retinoblastoma, cystic fibrosis,~     and Huntington's chorea. The investigators propose to study the genetic changes in patients~     with familial glioma as a first step in identifying the gene(s) that cause these tumors.~   "
261574|NCT00125697|"~     Malignant glioma is the most common primary brain tumor in adults. Despite aggressive~     therapy, less than 40% of these patients are expected to live beyond 5 years. The radiologic~     imaging of these tumors relies on computed tomography (CT) and magnetic resonance imaging~     (MRI) - these studies provide good anatomical information about the size and location of the~     tumor, but are unable to evaluate whether the tumor is still viable or contains metabolic~     activity, after surgery and, in particular, radiotherapy (RT). This complicates accurate~     understanding of the status of the tumor during a patient's follow-up. This study proposes to~     add magnetic resonance spectroscopy, a non-invasive imaging method which can monitor~     metabolic changes in the tumor, to regular imaging. Understanding the changes that occur in a~     tumor over the course of radiotherapy could help predict how well a treatment might work, and~     could also be useful in distinguishing a return of the tumor in an area of radiation damage~     before it would be obvious on regular imaging.~   "
261575|NCT00125684|"~     Patients will participate in two arms of the trial, one in which morphine will be~     administered transdermally, and, after a 3 day wash out period, one in which morphine will be~     administered subcutaneously.~   "
261576|NCT00125671|"~     The purpose of this study is to evaluate whether the addition of warfarin (a blood-thinning~     medication) to an antiplatelet therapy like aspirin is better than antiplatelet therapy alone~     (i.e. usual treatment) for the prevention of leg surgery, heart attacks, stroke and death in~     people with peripheral vascular disease.~   "
261577|NCT00125658|"~     The results of this study will provide sound, scientific evidence of physiologic mechanisms~     responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular~     adaptation; and will elucidate the relationship between impairment and motor disability in~     post-stroke hemiparesis.~   "
261578|NCT00125645|"~     The purpose of this study is to compare changes in global left ventricular (LV) function~     after 3 months of treatment with irbesartan compared with usual care in patients with acute~     myocardial infarction, a wall motion score >1.3 (EF>0.40) and signs of diastolic dysfunction.~     The hypothesis is that an angiotensin 2-receptor inhibitor will improve global left~     ventricular function.~   "
261579|NCT00125632|"~     The purpose of this study is to measure the effectiveness of a newly-designed oculomotor~     training program for patients with age-related macular degeneration.~   "
261580|NCT00125619|"~     The overriding goal of this proposal is to identify the critical physiological and~     biomechanical effects of BWSTT for promoting improved locomotor function in persons with~     post-stroke hemiparesis.~   "
261604|NCT00125307|"~     The investigators study the efficacy and safety of tacrolimus in the treatment of membranous~     nephritis secondary to systemic lupus erythematosus.~   "
261581|NCT00125606|"~     For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell~     transplantation (HSCT) is one of the most potent treatment options currently available. In~     order to overcome the high risk of fatal treatment-related complications, reduced intensity~     and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored~     in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the~     optimal dose-intensity of preparative regimens for disease control at an acceptable rate of~     treatment-related lethal complications has not been determined. The investigators, therefore,~     evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML~     patients considered ineligible for conventional conditioning in a phase 2 trial (data~     published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy~     TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML~     patients in first or second complete remission (CR) with a remarkably low 2-year non relapse~     mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3~     trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German~     Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning~     with TBI 12 Gy/cyclophosphamide.~   "
261582|NCT00125593|"~     The chief aim of SHARP was to determine whether lowering blood LDL cholesterol with~     simvastatin (20mg) plus ezetimibe (10mg) daily could safely reduce the risk of coronary heart~     disease, non-hemorrhagic stroke and the need for revascularization procedures in patients~     with chronic kidney disease (CKD). It also aimed to assess whether lowering LDL cholesterol~     reduced the rate of loss of renal function in people with CKD who had not commenced dialysis~     treatment.~   "
261583|NCT00125580|"~     Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even~     among very young children. A recent report from the National Health and Nutrition Examination~     Survey (NHANES) revealed that from 1999 to 2002, 10.3% of children ages 2 to 5 were~     overweight, an increase from 7% in 1994. Epidemiologic evidence is now emerging that suggests~     obesity in childhood and adulthood may often originate from accelerated weight gain during~     infancy. Further data are accumulating that link short sleep duration with obesity during~     childhood and later life. Prospective data are lacking that demonstrate whether the~     accelerated weight gain during infancy can be prevented and whether interventions to improve~     sleep early in life can prevent childhood obesity.~      Key Objectives:~      The key objectives are:~        -  To adapt a procedure aimed at prolonging sleep duration during infancy that is effective~          in experimental settings to the clinical setting of primary care; and~        -  To evaluate, in the primary care setting, the effect of a simple training procedure on~          overnight sleep duration and rate of weight gain during the first four months of life.~   "
261584|NCT00125567|"~     The purpose of this study is to demonstrate in patients with Parkinson's disease that, when~     compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to~     the time an increase in antiparkinsonian medication is required due to inadequately~     controlled parkinsonian symptoms.~   "
261585|NCT00125554|"~     The purpose of this study is to test whether metyrapone is an effective and safe augmenting~     agent in the treatment of major depression.~   "
261586|NCT00125541|"~     A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of~     nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the~     treatment of hereditary angioedema (HAE) will be performed. This study (KB2003.01) consists~     of three parts: Part A - pharmacokinetics (phase II); Part B - treatment of attacks of~     angioedema (phase III); and Part C - prophylactic use of C1 inhibitor (phase III). Parts B +~     C will provide data on the efficacy of C1-esteraseremmer-N.~      The changes within the manufacturing process of C1-esteraseremmer-N, compared to Cetor®~     nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect~     tolerability. The nanofiltration will provide more safety regarding viruses.~      In part C of the study, a number of HAE patients will be treated prophylactically with~     open-label C1-esteraseremmer-N for a period of 16 weeks. The number of attacks occurring will~     be compared with historical data. If possible, also some patients treated prophylactically~     with C1 inhibitor for acquired angioedema will be included.~   "
261587|NCT00125528|"~     Pre-clinical studies in rats suggest that D-cycloserine (DCS) is effective in the management~     of chronic neuropathic pain. This pilot study will attempt to determine the effect of~     D-cycloserine in the treatment of chronic low back pain. Other aims of this study are to~     determine the safety of D-cycloserine in the treatment of chronic low back pain and to~     determine which pain measurement scales are best at measuring the efficacy of treatment.~   "
261588|NCT00125515|"~     The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor~     antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified~     heroin-dependent individuals.~   "
261589|NCT00125502|"~     The purpose of this study is to determine if a new cytomegalovirus (CMV) vaccine (CMV~     gB/MF59) can safely prevent mothers from catching CMV infection between pregnancies. This~     study includes 464 women, ages 14-40 years, who delivered a newborn infant within 12 months~     prior to the study. Participants must live within the Birmingham metropolitan area or the~     Tuscaloosa county area and they cannot have had CMV infection previously. CMV vaccine or~     placebo (substance containing no medication) will be given at 3 study visits. Participants~     fill out diary cards for 7 days after each vaccination. Blood samples will be collected.~     Urine samples will be collected several times and pregnancy tests will be performed.~     Participants who tested positive for CMV will have urine, vaginal swab, and saliva specimens~     collected. Each participant will be followed for 3 years after the third dose of vaccine.~     Infants born to participants in the study will be checked for CMV infection.~   "
261605|NCT00125294|"~     A dose titration protocol for sublingual methadone hydrochloride for the management of~     cancer-related breakthrough pain to find the optimal dose.~   "
261620|NCT00125099|"~     The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be~     safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The~     study will also test whether the vaccine can increase the immune system function in these~     participants.~   "
261621|NCT00125086|"~     This study will examine whether platelet gel positively affects wound healing. Platelet gel~     will be used to treat punch biopsy wounds and the results will be compared to results from~     wounds treated with a control treatment.~   "
261590|NCT00125489|"~     The purpose of this research study is to find out how well chloroquine works as a drug to~     treat malaria in children, compared to the standard malaria treatment in Malawi. In~     preparation for a longer study of the malaria treatment medication chloroquine alone and in~     combination with other drugs, a shorter pre-study will be done to compare the anti-malarial~     effectiveness of chloroquine versus sulfadoxine-pyrimethamine (SP), the standard treatment in~     Malawi. Two hundred ten children, ages 6 months to 12 years, around Blantyre, Malawi, will be~     given standard dosing of either chloroquine or SP when they come to the Ndirande Health~     Centre with signs or symptoms consistent with malaria. The first 30 participants in each~     treatment group will remain under continuous observation at the health center so that the~     researchers can monitor their response to the medication until the infection goes away. The~     participants will be followed for 28 days to see if the the treatment works or fails.~   "
261591|NCT00125476|"~     This study is a prospective follow-up study to the Dose-Response to Exercise in Women (DREW)~     study. In DREW, 450 overweight, sedentary postmenopausal women were randomly assigned to~     either a non-exercise control group or to 1 of 3 weekly physical activity groups. The DREW~     study is evaluating the dose-response of exercise training in regard to changes in multiple~     cardiac risk factors. This study will measure diastolic heart function in a subset of the~     DREW population in order to examine the relationship between dose response, changes in~     physical activity, and diastolic function. Diastolic heart function will be assessed using~     both traditional and novel echocardiographic measures.~   "
261592|NCT00125463|"~     The purpose of this study is to compare an angiotensin II receptor antagonist (candesartan~     cilexetil– Blopress®) and a calcium channel blocker (amlodipine besilate– Norvasc®/Amlodin®)~     in terms of the incidence of cardiovascular events among high-risk hypertensive patients.~   "
261593|NCT00125450|"~     The purpose of this study is to determine whether chest physiotherapy with forced expiratory~     technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24~     months of age.~   "
261594|NCT00125437|"~     The purpose of this study is to determine whether a larger dose of the aldosterone antagonist~     spironolactone combined with a lower dose of an ACE inhibitor is more effective in reverse~     left ventricular remodeling in severe congestive heart failure in patients with nonischemic~     cardiomyopathy.~   "
261595|NCT00125424|"~     Very often, patients receive sedative medication before a diagnostic, therapeutic, or~     surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is~     called procedural sedation. During procedural (mild to moderate) sedation, a patient is first~     given a pain-relief medication (analgesic) and then a medication to help him/her relax and~     keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it~     releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol~     disodium) is made as a slow release version of propofol, allowing for fast sedation and~     possibly faster recovery and discharge.~      This study is intended to compare several different doses of AQUAVAN in patients having a~     colonoscopy in order to find the right dose that will get patients to a level of mild to~     moderate (procedural) sedation.~   "
261596|NCT00125411|"~     This is a single center, open-label, non-randomized, Phase I dose finding study of the~     investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in~     patients with advanced solid tumors for whom curative therapy is not available. Please refer~     to the Eligibility Criteria below for key inclusion and exclusion criteria.~      PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the~     combination of satraplatin and docetaxel when given to patients with advanced solid tumors.~      WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member~     of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically~     proven to be one of the most effective classes of anticancer therapies. Unlike the currently~     marketed platinum-based drugs, satraplatin can be given orally.~   "
261597|NCT00125398|"~     Patients who are in the intensive care unit after surgery and require mechanical breathing~     support (intubation and ventilation) usually require sedation to avoid agitation and~     excessive stress responses. Short-acting sedatives such as midazolam and propofol are the~     drugs typically used for this. Propofol provides for fast sedation and fast recovery from~     sedation. Midazolam is slower to sedation and slower for recovery, but may provide some~     advantages over propofol, such as a lower incidence of hypotension (low blood pressure). This~     study will look at propofol compared to a product with fast sedation and recovery like that~     of propofol but with less of a chance for hypotension like with midazolam. Patients will be~     treated with the product for up to 8 hours and then will be monitored for 8 hours following~     treatment.~   "
261598|NCT00125385|"~     This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is~     safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without~     excessive side effects will be identified. Tests will determine how long GC1008 is in the~     body and how it is excreted.~   "
261599|NCT00125372|"~     The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and~     Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by~     the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the~     treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.~   "
261600|NCT00125359|"~     The purpose of this study is to learn about the effects of two new anticancer drugs,~     erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung~     cancer.~      Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of~     non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of~     cutaneous T-cell lymphoma. This combination of drugs is experimental.~   "
261601|NCT00125346|"~     Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients~     with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can~     cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an~     approved antibiotic, which is inhaled directly into the lungs, and can be used to manage~     these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder~     formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The~     purpose of this research study is to determine if TIP is safe and effective when compared to~     placebo (a powder with no medicine) treatment.~   "
261606|NCT00125281|"~     This study will examine the effect of S-adenosyl methionine (SAMe) on itching and fatigue in~     patients with primary biliary cirrhosis, a disease of the small bile ducts in the liver.~     Ursodiol, the only currently available treatment for biliary cirrhosis, does not cure the~     disease, and many people continue to have symptoms or liver test abnormalities despite~     treatment. SAMe is a naturally occurring substance found in most cells of the body. The~     highest levels of the substance are produced by the liver, where it helps to rid the body of~     toxins and breakdown products of metabolism. Studies in Europe suggest that SAMe may help to:~     1) decrease the fatigue and itching that are common in persons with liver problems, and 2)~     decrease levels of liver enzymes in the blood, suggesting that it may decrease the amount of~     liver injury.~      Patients 21 years of age or older with primary biliary cirrhosis who are taking ursodiol and~     have symptoms of itching or fatigue may be eligible for this study. Candidates are screened~     with a medical history, physical examination, review of medical records, routine blood tests,~     and a symptoms rating scale.~      Participants stop all medications for itching 4 weeks before starting the study, but continue~     to take ursodiol during the 42-week trial. On entering the study, patients are assigned to~     take either SAMe or placebo tablets twice a day for 12 weeks. While taking the medications,~     they are followed in the clinic every 2 weeks for the first month and then every 4 weeks to~     fill out symptoms questionnaires and have a short medical evaluation and blood tests. At the~     end of 12 weeks, treatment is interrupted for a 2-week wash-out period, after which~     patients begin a 12-week crossover treatment; that is, patients who were taking SAMe are~     switched to placebo, and those who were taking placebo are switched to SAMe.~      After completing the second 12-week treatment course, patients come to the clinic at 4, 8,~     and 12 weeks to fill out symptoms questionnaires and have a medical evaluation and blood~     tests. At the last visit, patients are told which type of tablet they received during the two~     courses of treatment. SAMe is available without prescription in many forms as an~     over-the-counter medication.~   "
261607|NCT00125268|"~     The purpose of this study is to determine if near infrared light therapy is effective in~     decreasing pain in patients with painful peripheral neuropathy. The hypothesis of the study~     was that the percentage of subjects with at least 40% improvement in visual analog scale~     score for pain after 4 weeks of treatment is higher for Monochromatic Near-infrared~     Photoenergy (MIRE) treatment than for sham treatment.~   "
261608|NCT00125255|"~     The pain associated with medical procedures is often under-treated in children. Children~     often undergo painful procedures with little or no anesthetic, even when effective therapy is~     available. Reasons for not providing available therapy in children include concerns over~     adverse side effects as well as the length of time necessary to provide adequate anesthesia.~     Recent guidelines strongly advocate for the proactive treatment of pain in children,~     including the pain associated with medical procedures.~      S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine~     and tetracaine. The purpose of this study is to evaluate whether S-Caine Peel is effective in~     providing topical local dermal anesthesia prior to a vascular access procedure in children 5~     through 17 years of age.~   "
261609|NCT00125242|"~     The purpose of this investigation is to further develop and test a treatment for word-finding~     problems in aphasia. The treatment is designed to strengthen meaning associations within~     categories of words (e.g., animals, tools, fruits). The treatment is also designed to be used~     as a search strategy in instances of word-finding difficulty. The study was devised to~     evaluate the extent to which treatment increases the ability to recall trained, as well as~     untrained, words.~   "
261610|NCT00125229|"~     This is a clinical study comparing the physiologic effects of two hypertonic solutions~     (mannitol, hypertonic saline) with a particular emphasis on changes in cerebral blood flow in~     patients with intracranial hypertension following serious traumatic brain injury (TBI).~   "
261611|NCT00125216|"~     The purpose of this study is to evaluate the effects of Response Elaboration Training (RET),~     which is a speech/language therapy for aphasia. The study is designed to determine whether~     verbal language production improves in terms of content and length of utterances as a result~     of treatment.~   "
261612|NCT00125203|"~     The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients~     who are having excessive drooling.~      The primary goal of the study is to determine if the patient perceives a benefit from the~     Myobloc in controlling excessive drooling.~   "
261613|NCT00125190|"~     This study is intended to assess the effects of once daily dosing of recombinant human~     insulin-like growth factor (rhIGF-1) in increasing height velocity.~   "
261614|NCT00125177|"~     The IRIS project stands for Incontinence Research Intervention Study. The purpose of this~     research project is to develop an effective behavioral therapy for urinary incontinence and~     specifically to test Knack therapy, a self-help treatment. The Knack therapy involves~     learning the skill of performing a pelvic muscle contraction simultaneously with an event~     known to trigger leakage, in order to stop that leakage.~   "
261615|NCT00125164|"~     This study is intended to determine whether twice daily weight based dosing with recombinant~     human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of~     prepubertal children with short stature associated with low IGF-1 levels but who produce~     sufficient growth hormone (GH). Subjects will be randomized to either an observation arm or~     to active treatment.~   "
261616|NCT00125151|"~     A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of~     nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the~     treatment of hereditary angioedema (HAE) will be performed. This study (KB2003.01) consists~     of three parts: Part A - pharmacokinetics (phase II); Part B - treatment of attacks of~     angioedema (phase III); and Part C - prophylactic use of C1 inhibitor (phase III). Parts B +~     C will provide data on the efficacy of C1-esteraseremmer-N.~      The changes within the manufacturing process of C1-esteraseremmer-N, compared to Cetor®~     nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect~     tolerability. The nanofiltration will provide more safety regarding viruses.~      In Part B of the study, 15 attacks of hereditary angioedema will be treated with open-label~     C1-esteraseremmer-N. Attack severity and duration will be monitored by the subjective~     experience of the patient himself (which has been shown to be the most sensitive way of~     monitoring attack severity) and compared with historical (and literature) data. If possible,~     some attacks of acquired angioedema will also be included.~   "
261617|NCT00125138|"~     The purpose of this study is to evaluate the safety and efficacy of three target doses of~     melperone compared to placebo in the treatment of psychosis associated with Parkinson's~     disease. Subjects will be enrolled at approximately 20 investigational sites in the United~     States (U.S.) and 15 Ex-US sites. The maximum study duration will be 10 weeks. Subjects will~     have the option of continuing in an open-label extension study.~   "
261618|NCT00125125|"~     The purpose of the study is to find a good therapy for patients who need to be treated for~     high cholesterol and who have difficulty tolerating other statins (such as pravastatin,~     simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.~   "
271141|NCT00037362|"~     To develop a new statistical index that measures sensitivity to non-ignorability (index of~     sensitivity to nonignorability, or ISNI) for model-based inferences.~   "
261622|NCT00125073|"~     This study aims to assess the changes in physical characteristics, food intake, eating~     behavior, vomiting, and dumping in 100 patients who undergo bariatric surgery. Patients are~     put into one of two conditions; they will either receive standard postoperative care or~     biweekly counseling sessions with a dietician that will help them with the postoperative~     diet. Patients who receive dietary counseling are anticipated to experience greater weight~     loss and report less consumption of sugar and fat as compared to patients who do not receive~     dietary counseling. Moreover, patients who receive dietary counseling are predicted to report~     less frequent nausea, vomiting, and gastric dumping, as compared to patients who do not~     receive postoperative dietary counseling. This is predicted to result as a consequence of~     increased dietary adherence evidenced by the former group.~   "
261623|NCT00125060|"~     This research is being done to investigate the ability of an experimental imaging method -~     transesophageal magnetic resonance imaging (TEMRI), to detect the change in aortic~     atherosclerotic plaque burden and morphology between patients on high dose cholesterol~     lowering medications and patients on standard dose cholesterol lowering medications. This~     study will use TEMRI to see how atherosclerosis (cholesterol build up) changes with~     cholesterol lowering medications. This study will also investigate whether these~     cholesterol-lowering medications will change levels of blood tests, called inflammatory~     markers, in patients' blood. People with atherosclerosis may join this study. This study will~     also store blood samples for future studies of cardiac diseases; no gene testing will be~     done.~   "
261624|NCT00125047|"~     This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration~     project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic~     countries. The purpose of this study is to determine the effectiveness of the Vi vaccine~     following a mass typhoid immunization campaign in an endemic area in Karachi, Pakistan. The~     cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid~     immunization campaign will also be evaluated.~   "
261625|NCT00125034|"~     This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA +~     oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for~     epidermal growth factor receptor (EGFR)-expressing mCRC.~   "
261626|NCT00125021|"~     This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774)~     combined with capecitabine in treating patients with metastatic pancreatic cancer.~   "
261627|NCT00125008|"~     This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration~     project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic~     countries. The purpose of this study is to determine the effectiveness of the Vi vaccine~     following a mass typhoid immunization campaign in an endemic area in Kolkata, India. The~     cost-effectiveness of the Vi vaccination and the logistic feasibility of a mass typhoid~     immunization campaign will also be evaluated.~   "
261628|NCT00124995|"~     Although widely used for the treatment of pediatric status asthmaticus, intravenous~     terbutaline has potentially significant side effects; may not improve outcomes; and may~     increase Intensive Care Unit (ICU) length of stay. This study is designed to test the~     efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding~     intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or~     placebo will be titrated according to severity of illness as quantified by a validated~     clinical asthma score. Differences in outcomes between the study groups, such as length of~     stay, hospital costs, and lung function will be compared.~   "
261629|NCT00124982|"~     The purpose of this study is to summarize the safety and tolerability of abatacept during 6~     months of combined treatment with one or more of the background non-biologic disease~     modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects~     with active RA. Secondary objectives assessed the clinical efficacy of combination treatment,~     including disease activity, physical function, and quality of life outcomes.~   "
261630|NCT00124969|"~     Patients with end-stage renal failure have a markedly higher mortality because of~     cardiovascular events in comparison with the normal population. Disorders in the calcium~     metabolism, such as calcification of the vessel walls, occur very frequently. There are~     indications that calcium channel blockers are capable of lowering the cardiovascular~     mortality in patients with end-stage renal failure.~      It is intended to carry out a prospective, randomized, double-blind, placebo-controlled,~     multicenter study in order to find out if the calcium channel blocker amlodipine is able to~     reduce the mortality of patients with end-stage renal failure.~      The investigation will be carried out after suitable explanation and written informed consent~     in 356 patients aged between 18 and 90 years with end-stage renal failure and chronic~     haemodialysis treatment. The patients will be randomized to either treatment with amlodipine~     10 mg/day or placebo. The occurrence of events will be documented and evaluated prospectively~     over a period of 30 months.~   "
261631|NCT00124956|"~     This protocol is designed to obtain detailed information on the impact of body composition on~     the pharmacokinetic behavior of doxorubicin after a single intravenous dose in children 21~     years of age or younger. There is no efficacy component. Approximately 9 children will be~     enrolled at Children's Hospital Boston. The information gained from this study could be very~     important in developing dosing strategies for doxorubicin in the obese patient population.~   "
261632|NCT00124943|"~     The purpose of this study was to investigate the use of systemic intracoronary administration~     of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis~     following de novo stenting or following angioplasty for in-stent restenosis.~   "
261633|NCT00124930|"~     The purpose of this study is to compare the efficacy and safety of Haldol (haloperidol) and~     olanzapine in the control of chronic nausea with advanced cancer patients who have failed~     first line antiemetic therapy.~   "
261656|NCT00124605|"~     Drugs used in chemotherapy, such as arsenic trioxide and pamidronate, work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Arsenic trioxide and pamidronate may also stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Pamidronate may also stop the growth of~     cancer cells by blocking blood flow to the cancer. Giving arsenic trioxide together with~     pamidronate may kill more cancer cells. This phase I trial is studying the side effects and~     best dose of arsenic trioxide and pamidronate in treating patients with advanced solid tumors~     or multiple myeloma~   "
261634|NCT00124917|"~     BACKGROUND:~      -This study represents a progression from findings in four previous NCI ROB protocols~     (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to~     develop techniques to obtain MR biological images and co-register tissue in prostate cancer~     patients.~      OBJECTIVES:~      -The scientific objective of this protocol is to determine the maximum tolerated dose (MTD)~     of external beam radiation to regions of interest within the prostate based acute toxicity.~      Secondary objectives of this study are to relate patterns in gene and protein expression to~     response and toxicity and to evaluate the frequency of late term toxicity.~      ELIGIBILITY:~      -Patients with prostate cancer without evidence of metastasis will be eligible for this~     study.~      DESIGN:~        -  This phase I trial will use intensity modulated radiation therapy (IMRT) to deliver~          escalating doses of external beam radiation to regions of histologically confirmed~          prostate cancer. The study will be conducted using a standard 3-6 dose-escalation with~          an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6~          patients.~        -  Anatomic MRI and MR biological images, such as MRS, will be obtained Tissue will be~          acquired from sites of interest, with biopsy locations precisely translated~          (co-registered) to an MR image of reference. Tissue samples will be processed for cDNA~          microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI.~          A gold seed will be left at the biopsy site as a fiducial marker to direct future~          radiation therapy. If necessary, additional fiducial markers will be placed for target~          localization during treatment.~        -  Once MR guided biopsies are obtained and fiducial markers placed, the patient will~          undergo a standard CT simulation for radiation therapy treatment planning. The MR and CT~          images will be fused. Areas of pathologically confirmed malignancy will undergo dose~          escalation as described below. Areas of image abnormality that could not be biopsied or~          were without definite pathologic evidence of malignancy will be given intermediate~          doses. The remainder of the prostate gland will receive standard dose (7560 cGy.)~        -  The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years.~   "
261635|NCT00124904|"~     Fecal incontinence affects 2% of adults in the United States. Biofeedback has been~     recommended for the treatment of fecal incontinence because uncontrolled studies over the~     past 25 years suggest that these treatments are as effective as medical or surgical~     management and involve no risk. However, placebo-controlled trials are still lacking.~      The aims of this study are: (1) to compare biofeedback to alternative therapies for which~     patients have a similar expectation of benefit; (2) to identify which patients are most~     likely to benefit; and (3) to assess the impact of treatment on quality of life.~   "
261636|NCT00124891|"~     To determine whether the administration of test article will decrease the occurrence of~     ventricular arrhythmias in patients who have acute coronary syndrome (unstable angina, ST~     segment elevated myocardial infarction or myocardial infarction without ST elevation).~   "
261637|NCT00124878|"~     This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV~     positive men and 500 men who declined to learn HIV results (regardless of HIV status). The~     hypotheses are that male circumcision will be acceptable to and safe in both groups and will~     reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative~     men.~      Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board~     (DSMB) review of a closed report. At that time the DSMB determined that futility with respect~     to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in~     women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical~     wound healing. The data indicated significant reductions (~50%) in GUD symptoms among~     circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be~     followed in complete two year follow up on all, 2) that circumcision for remaining HIV+~     intervention arm men and for control arm men who had completed their 2 year follow should~     continue, contingent on a) revision of the study protocol to add additional post-surgical~     visits to assess wound healing, b) protocol revision to further strengthen education for both~     male and female partners on the need to postpone sex until certified wound healing, and c)~     approval of the revised protocol by the IRBs in both the US and Uganda. 3) An additional~     follow up visit for women be instituted at 18 months after enrollment. Protocol revision and~     IRB approvals have been finalized in June, 2007.~      The study has also enrolled and is following 3,700 women sexual partners of men enrolled in~     this study and in a complementary National Institutes of Health (NIH) funded study (U1~     AI51171 which is separately registered). The hypotheses are that male circumcision will be~     acceptable to and safe in women partners, and will reduce the women's acquisition of HIV and~     STDs such as herpes simplex virus-2 (HSV-2) and human papillomavirus (HPV).~   "
261638|NCT00124865|"~     This study is an open-labeled dose escalating trial in which a total of 32 subjects will~     receive one of four intranasal rFla-MBP vaccine doses.~   "
261639|NCT00124852|"~     The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled~     trial with cognitive decline and early signs of depression as primary outcome measures.~   "
261640|NCT00124839|"~     The purpose of this study is to investigate whether naltrexone reduces the intensity and~     duration of flashbacks and dissociative states in patients with borderline personality~     disorder.~   "
261641|NCT00124826|"~     High blood sugar (hyperglycaemia) affects 40% of acute stroke patients and has a major~     adverse effect on survival and recovery. Increased production of lactic acid in brain tissue~     that has a poor blood supply is postulated to be the mechanism by which high blood sugar may~     worsen brain injury after stroke. Treatment with insulin infusions is proposed as a~     neuroprotective strategy, and a clinical trial is ongoing to test this hypothesis. However,~     the biological basis for insulin treatment has not been established, and there is uncertainty~     about the duration of insulin infusion that may be required to limit damage.~      Magnetic resonance spectroscopy (MRS) is a brain scanning technique that allows measurement~     of brain lactic acid. When performed in conjunction with conventional MRI scanning, the~     relationship of lactate accumulation to stroke expansion can be established. SELESTIAL is a~     randomised, placebo-controlled trial of insulin infusions of 24 or 72 hours (h) duration in~     acute stroke patients with hyperglycaemia, to establish whether insulin prevents lactate~     accumulation over the initial 72h after stroke, how this relates to stroke evolution, and the~     effect of treatment on stroke size and clinical outcomes at 1 week.~   "
261642|NCT00124813|"~     Background: In some studies, thalidomide in combination with chemotherapy has been shown to~     be effective in patients with relapsed or refractory multiple myeloma (MM). In this study,~     the researchers have chosen a regimen which can be administered on an outpatient basis.~      Induction therapy: To evaluate the efficacy and toxicity of thalidomide, cyclophosphamide,~     oral idarubicin and dexamethasone (T-CID) in patients with relapsed or refractory multiple~     myeloma.~      Maintenance therapy: Randomized trial to compare efficacy and toxicity of thalidomide and~     thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable~     disease after T-CID.~   "
261643|NCT00124800|"~     The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT)~     as a treatment of chronic tinnitus in people with limited hearing loss. The study design is~     prospective, randomized, double-blind, with repeated measures. The null hypothesis states~     there will be no difference in subjective measures of tinnitus severity between subjects~     treated with standard TRT and subjects treated with sham TRT.~   "
261668|NCT00124436|"~     Patients who have been treated in study protocol BAP089 may have responded to treatment, and~     subsequently relapsed to >75% of the baseline disease severity, will be investigated for~     response to further treatment with alitretinoin. Also, patients who have responded with mild~     or moderate disease will be investigated for additional treatment effect after prolongated~     treatment.~   "
261644|NCT00124787|"~     Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an~     ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by~     the vestibular system, which is rich in histamine receptors. Multiple studies have shown its~     effectiveness in treatment of post-operative nausea and vomiting in children. It is also used~     for treatment of vertigo in children. Furthermore, it has the potential to be much more~     cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal~     side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and~     insomnia have also been described in children. To date, there has been no published data on~     the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis.~      RESEARCH QUESTION~      Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less~     vomiting episodes than children treated with placebo?~   "
261645|NCT00124774|"~     This is a prospective randomised double blind comparison trial. Fifty patients will be~     included, 25 in the nucleoplasty treatment group, 25 in the control group. The nucleoplasty~     group will undergo the nucleoplasty treatment. Control group will undergo a sham treatment.~     Both groups will undergo a standardised post-operative care program. The study hypothesis is~     that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment.~   "
261646|NCT00124761|"~     This study examines surgery versus radiosurgery (highly focussed radiation) for the treatment~     of cancer which has spread to one spot in the brain (solitary brain metastasis). For these~     two treatment options, it will compare patients' survival times, quality of life, control~     rate of the brain metastases and side effects. It uses the most rigorous scientific method~     available called randomisation which minimises biases that exist with other types of~     studies. It will involve 30 - 40 patients.~   "
261647|NCT00124748|"~     This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients~     with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP)~     using molecular endpoints.~   "
261648|NCT00124735|"~     The primary purpose of this study is to determine the dose requirements of rocuronium bromide~     when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube~     through the nose or mouth into the trachea to provide artificial ventilation) and when~     administered by either continuous infusion or bolus doses for maintenance of muscle~     relaxation in term neonates (birth to <28 days old), infants (28 days to <=3 months) and~     toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of~     age), and adolescents (>11 years to less than or equal to 17 years of age).~   "
261649|NCT00124722|"~     The primary purpose of this study is to evaluate the time course of muscle relaxation after~     administration of three different single intravenous bolus doses of rocuronium bromide for~     intubation (insertion of a tube through the nose or mouth into the trachea to provide~     artificial ventilation) in term neonates (birth to <28 days old), infants (28 days to <=3~     months) and toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11~     years of age), and adolescents (>11 years to less than or equal to 17 years of age).~      Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg,~     0.6 mg/kg, or 1.0 mg/kg.~   "
261650|NCT00124709|"~     This study consists of a 3-year double-blind phase during which patients will receive atopic~     dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or~     with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year~     open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the~     double-blind phase, the two treatment groups will be compared with respect to their efficacy~     in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years~     will be compared.~   "
261651|NCT00124696|"~     Cocaine has been cited as the primary drug threat in the United States. The purpose of this~     study is to determine if cocaethylene, used as a prototype drug, is a safe and effective~     treatment for cocaine dependence.~   "
261652|NCT00124683|"~     Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to~     quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR~     (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping~     schizophrenic individuals quit smoking. In addition, this study will evaluate how the~     combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.~   "
261653|NCT00124657|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation~     therapy. Giving radiation therapy together with erlotinib may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when~     given together with radiation therapy and to see how well they work in treating young~     patients with newly diagnosed glioma.~   "
261654|NCT00124644|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine, daunorubicin, and etoposide, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Tipifarnib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Giving combination chemotherapy together with~     tipifarnib may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when~     given together with combination chemotherapy in treating patients with newly diagnosed acute~     myeloid leukemia.~   "
261655|NCT00124618|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation~     therapy works in treating patients with stage III non-small cell lung cancer.~   "
261690|NCT00124150|"~     The IMASH trial is a simple, randomized, double-blinded, placebo-controlled, multi-center~     trial to answer the question: Does intravenous magnesium sulfate improve clinical outcome~     after aneurysmal subarachnoid hemorrhage?~   "
271142|NCT00037349|"~     To investigate whether impaired heart-rate recovery after exercise is a powerful and~     independent predictor of mortality.~   "
261657|NCT00124579|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune~     system in different ways and stop cancer cells from growing. It may also stop the growth of~     cancer by blocking blood flow to the cancer. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving bortezomib together with thalidomide and~     dexamethasone may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide~     and dexamethasone works in treating patients with relapsed or refractory multiple myeloma.~   "
261658|NCT00124566|"~     The purpose of this study is to assess the efficacy and safety of irofulven-based regimens~     compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer~     (HRPC) whose disease has progressed following Taxotere based regimens.~   "
261659|NCT00124553|"~     In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes~     (T2DM). More recently, this aspect of treatment has received less attention as drug therapy~     aimed not only to lower glucose, but also to treat raised blood pressure and blood fats~     (including cholesterol) has been more widespread. While there is evidence to suggest that~     blood pressure and blood fat levels have improved, overall diabetes control has not and~     people with diabetes appear to be becoming progressively more overweight, following trends in~     the general population. The proposed study involves a randomised controlled trial in which~     people with T2DM continuing with their regular drug treatment and surveillance, will be~     randomly allocated to additionally receive intensive advice regarding diet or remain on their~     usual treatment in this regard. The results will be judged principally in terms of body~     weight, waist circumference, blood pressure, blood glucose control and blood fats.~   "
261660|NCT00124540|"~     This hospital-based, multicenter, randomized, placebo-controlled trial will assess the~     effects of misoprostol as part of active management of the third stage of labor on postpartum~     blood loss, complications, and side effects. Twelve hundred eligible women will receive~     routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo~     during or immediately after delivery. The primary outcome will be measured blood loss of~     =>500 mls within one hour after enrollment.~   "
261661|NCT00124527|"~     Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid~     tumors. The purpose of this study is to assess the efficacy and safety of~     irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally~     advanced/metastatic differentiated thyroid cancer.~   "
261662|NCT00124514|"~     The purpose of this study is to test the safety of triptorelin when used for the protection~     of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for~     systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on~     patients. The study will be done with female patients who have been diagnosed with systemic~     lupus erythematosus, are younger than 21 years of age, and require intravenous~     cyclophosphamide to control the disease. Each patient will be in the study for approximately~     23 months, until 4 months after the intravenous cyclophosphamide treatment has been~     completed.~      This study is currently being conducted at 3 sites across the United States and Brazil (Los~     Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this~     study.~      Each patient will be randomized (assigned) to one of 5 groups. Randomization means that~     patients are put into a group completely by chance. It is like flipping a coin. Neither the~     patient nor the study staff knows what group the patient is in. The patient has a 20% chance~     of being placed in any group.~      Funding Source: FDA OOPD and Watson Pharmaceuticals~   "
261663|NCT00124501|"~     The purpose of this study is to determine whether the addition of Biofeedback-Assisted~     Relaxation to standard medication treatment improves outcomes for children with a specific~     type of recurrent abdominal pain (i.e., eosinophilic gastroenteritis).~   "
261664|NCT00124488|"~     Standard treatment for non-operable cervix cancer is radiation and chemotherapy. This~     treatment combination can result in significant radiation side-effects involving the bladder,~     small bowel and rectum. To improve results with radiation/chemotherapy, higher radiation~     doses have been tried for cervix cancer patients. Results from using higher radiation doses~     show that cervix tumours may be better controlled, but the radiation side-effects are~     worsened. Intensity modulated radiotherapy (IMRT) and Tomotherapy are new radiation planning~     and delivery technologies which may allow for delivery of higher radiation doses with less~     damage to normal organs. The purpose of this project is to determine whether or not IMRT~     and/or Tomotherapy technology can produce radiation plans that deliver higher doses of~     radiation to the tumor and lower doses to normal organs when compared to standard radiation~     plans. The results from this project will provide the basis for possibly treating future~     cervix cancer patients with Tomotherapy and providing them with improved cure rates along~     with decreased rates of radiation side effects. No patients will be treated on this protocol,~     as the investigators plan to only compare radiation dose calculations from different~     treatment plans created for test cervix cancer cases. There will be absolutely no patient~     contact in this protocol.~   "
261665|NCT00124475|"~     The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid,~     on severe, therapy refractory chronic hand dermatitis.~   "
261666|NCT00124462|"~     The overall objective of this 3-year project is to determine whether the provision of~     realignment therapy in patients with medial knee osteoarthritis (OA) relieves knee pain and~     improves function. The researchers will test the hypothesis that compared to control~     treatment, the use of realignment therapy (valgus knee brace + motion control shoes +~     orthosis) is effective in medial knee OA.~      The specific aims are:~        -  To undertake a 30 week randomized crossover clinical trial in patients with medial knee~          osteoarthritis to determine whether provision of realignment therapy leads to lower pain~          scores and improved function during the time of this treatment than during the use of a~          placebo treatment;~        -  To perform an open label follow-up study to track use and effectiveness of treatment.~          This project will be co-funded by DonJoy Orthopedic, a knee bracing company.~   "
261667|NCT00124449|"~     The purpose of this study is to assess if Abatacept given for six months will prevent~     rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison~     to placebo. High risk patients are defined as those having a positive laboratory test for~     anti-cyclic citrullinated peptide (anti-CCP2).~   "
261669|NCT00124423|"~     The Cross Cancer Institute has recently acquired a tomotherapy radiotherapy treatment~     machine; the first of its kind in Canada. It has the potential to improve cancer treatment~     outcomes where radiotherapy is used. Cervix cancer is a disease where radiotherapy is a~     particularly important treatment modality. The researchers believe that by combining~     tomotherapy (which has the ability to give higher doses of radiation to areas of cancer while~     sparing normal tissues) with radiotherapy given from inside the uterus and vagina~     (brachytherapy) disease outcomes will be improved. For this to be possible the researchers~     will need to accurately map the doses of radiation given to the cervix, uterus and other~     pelvic organs from these two types of radiation treatment. As well as being used for~     treatment, the tomotherapy machine can also be used for taking medical images by using very~     much lower doses of radiation. This study will allow the researchers to develop the mapping~     process by using very low doses of radiation on the tomotherapy unit to take medical x-ray~     images of patients being treated by brachytherapy for cervix cancer. In this special~     circumstance the researchers expect the images to be of a higher quality than for~     conventional computed tomography (CT) scanning or magnetic resonance imaging (MRI) scanning.~   "
261670|NCT00124410|"~     Osteoporosis, or thinning of the bones is a common disorder which can cause significant~     morbidity in terms of pain and fracture. One of the causes of osteoporosis is a low or absent~     testosterone level. Prostate cancer is the second most common malignancy in males with an~     increasing incidence. The mainstay of advanced prostate cancer treatment is hormonal~     manipulation (surgery or medications) in order to lower testosterone levels as testosterone~     stimulates cancer cells. Despite the known links both between osteoporosis, low testosterone,~     and prostate cancer, little data is available on how common osteoporosis is among men with~     advanced prostate cancer treated with hormonal manipulation. Since prostate cancer affects so~     many men and the indications for early hormonal manipulation are expanding, it is important~     to determine the prevalence of osteoporosis in these males.~   "
261671|NCT00124397|"~     The aim of this study is to examine the effect of intensive cholesterol lowering therapy and~     tight blood pressure (BP) regulation on endothelial function (inner cell layer of vessels~     that determines dilatation) in type 2 diabetic patients without documented cardiovascular~     (CV) disease. The hypothesis is that intensive cholesterol lowering and tight blood pressure~     regulation will due better than a control group.~   "
261672|NCT00124384|"~     This study examines how treatment with the drug modafinil, by itself or in combination with~     cognitive behavioral treatment for insomnia (CBT-I), may improve daytime functioning and/or~     diminish the severity of insomnia.~   "
261673|NCT00124371|"~     The time spent waiting for heart surgery can be extremely stressful. This programme aims to~     address this by providing a home-based, nurse-led support and education programme. Patients~     will be followed up in their own homes monthly by a cardiac nurse and given lifestyle advice~     and information to prepare them for surgery. This will be evaluated to test whether providing~     this support improves patients’ anxiety and quality of life while they wait and also whether~     their blood pressure, weight and cholesterol are reduced and they have a smoother recovery as~     a consequence.~   "
261674|NCT00124358|"~     The purpose of this study is to assess the feasibility, cost and effectiveness of~     interventions designed to integrate buprenorphine treatment for opioid dependence into HIV~     primary care in ten HIV care centers in the U.S.~   "
261675|NCT00124345|"~     In this study, the investigators aimed to study the role of medical gas humidification during~     noninvasive mechanical ventilation.~   "
261676|NCT00124332|"~     The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered~     during 18-20 months will reduce progression of coronary atherosclerosis as assessed by~     intravascular ultrasound (IVUS) when administered on top of standard behavioral and~     pharmacological therapy given as needed, in patients with abdominal obesity associated with~     current smoking and/or metabolic syndrome.~   "
261677|NCT00124319|"~     The anterior cruciate ligament (ACL) is located inside the knee joint and provides stability~     to the knee. ACL injuries occur more frequently in women than men; the reason for this is~     unknown. The purpose of this study is to determine gender-specific anatomical, hormonal, and~     demographic risk factors for ACL injury. This observational cohort study will only enroll~     incoming cadets at the U.S. Naval, Air Force, or Military Academies.~      Study hypothesis: Human movement factors, including key kinetics and kinematics of the knee~     during a jump-landing task, are associated with the rate of ACL injury.~   "
261678|NCT00124306|"~     This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in~     the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined~     by symptoms--frequent urination day and night and increasing pain as the bladder~     fills--according to the International Continence Society. The syndrome includes interstitial~     cystitis (IC), which has been estimated to affect as many as 700,000 people, mostly women.~     Estimates for PBS vary widely, but as many as 10 million people may suffer from this~     condition. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication~     used for depression, the way it works makes it useful for treating the pain of fibromyalgia,~     multiple sclerosis, and other chronic pain syndromes. Prior small studies in interstitial~     cystitis (IC) suggested the drug may be a wise choice for this syndrome as well, because it~     blocks nerve signals that trigger pain and may also decrease muscle spasms in the bladder,~     helping to relieve the symptoms of pain and frequent urination.~   "
261679|NCT00124293|"~     This study is conducted in North America. The purpose of this study is to evaluate the~     occurrence and severity of bleeding in brain injury and to identify important safety issues~     following traumatic brain injury.~   "
261691|NCT00124137|"~     The purpose of this study is to compare patients who are suffering from heart failure and who~     are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid~     as measured by weight loss while in the hospital and improve the patient's breathing.~   "
261692|NCT00124124|"~     In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or~     dendritic cells as adjuvants. This randomized trial will establish the safety of both~     vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.~   "
261693|NCT00124111|"~     The purpose of this study is to assess the relative dose intensity (RDI) of intravenous (IV)~     CMF on a Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with~     stage I-III breast cancer.~   "
261680|NCT00124280|"~     This study will evaluate the efficacy and safety of everolimus treatment of patients with~     advanced NSCLC. The rationale for investigating everolimus in advanced NSCLC previously~     treated with chemotherapy or chemotherapy plus EGFR inhibitors, like gefitinib or erlotinib,~     is based on following:~        -  The medical need for the better therapy for advanced NSCLC and limited efficacy of the~          currently available therapy in advanced NSCLC.~        -  Postulated association of relevant cell-signaling pathways targeted by everolimus with~          different aspects of oncogenesis, disease progression, and response/resistance to~          treatment.~        -  Effectiveness of everolimus and rapamycin in preclinical models of lung cancer~        -  Early reports of clinical responses to monotherapy with mTOR inhibitors in advanced~          NSCLC.~      There is evidence that an enhanced PI3K/Akt/mTOR pathway, which is inhibited by everolimus,~     may be one of the key changes accounting for different aspects of oncogenesis, disease~     progression, and response/resistance to NSCLC cancer treatment. The use of the mTOR inhibitor~     everolimus in treatment of advanced NSCLC would be a novel therapeutic approach that proposes~     to logically manipulate the cell's regulatory pathways to enable control of tumor growth.~   "
261681|NCT00124267|"~     Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality~     rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral~     malaria. However its administration is often not feasible due to lack of simple equipment or~     trained staff. When referral is not possible, a viable alternative is needed. The intrarectal~     route is of interest in children since it is painless and simple. Studies of the efficacy of~     intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to~     establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.~   "
261682|NCT00124254|"~     A procedure called silicone metacarpophalangeal joint arthroplasty (SMPA) is sometimes used~     to treat knuckle deformity in the hands of rheumatoid arthritis (RA) patients. The purpose of~     this study is to compare the health outcomes of RA patients who choose to undergo SMPA~     surgery to RA patients who do not undergo surgery.~   "
261683|NCT00124241|"~     This is an extension study for patients who have previously completed Idenix Study~     NV-02B-003. This study is being conducted to compare the safety and effectiveness of~     treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug~     currently approved for the treatment of hepatitis B.~   "
261684|NCT00124228|"~     Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe~     circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal~     failure is an important prognostic marker, representing the major predictive factor of~     in-hospital mortality.~      Recent studies have shown that plasma volume expansion with albumin associated with~     cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime~     treatment alone. The in-hospital and three-month mortality rates, furthermore, were~     significantly lower in the group treated with albumin.~      It is not known if other bacterial infections unrelated to SBP represent a risk factor for~     the development of renal failure among cirrhotic patients. The researcher's group has~     recently performed a study to evaluate the incidence, characteristics and outcome, of renal~     failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with~     the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of~     106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure~     was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/-~     0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important~     activation of endogenous vasoconstriction systems. The three-month survival probability of~     patients with infection and renal failure was 34 %, much lower than that of patients with~     infection but not presenting renal failure (87%, p<0.0001). These results suggest that the~     development of renal failure in patients with cirrhosis and bacterial infections different~     from SBP, associated with signs of a systemic inflammatory response, is very frequent and~     results in a very poor prognosis. Taken as a whole, these data strongly indicate the need to~     consider these patients as candidates for liver transplantation and to plan strategies for~     its prevention.~      The objective of this project, therefore, is to evaluate if the plasma volume expansion with~     albumin, associated with conventional antibiotic therapy, can prevent the development of~     renal failure and increase survival rates in cirrhotic patients with bacterial infections~     unrelated to spontaneous bacterial peritonitis.~   "
261685|NCT00124215|"~     The GI-5005 therapeutic vaccine or placebo will be injected under the skin of hepatitis C~     virus (HCV) subjects. Patients will be monitored for safety, immune responses and any~     therapeutic benefits related to the injections.~   "
261686|NCT00124202|"~     This study is to determine if a fatty meal would improve the ERCP procedure.~   "
261687|NCT00124189|"~     The purpose of this study is to determine the safety and maximum tolerated dose of GRN163L in~     treating patients with refractory or relapsed chronic lymphoproliferative disease.~   "
261688|NCT00124176|"~     This study will use a randomized, double-blind, controlled trial design in order to assess~     the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when~     delivered continuously in a high-dose regimen for children with severe exacerbations of~     asthma.~      Primary hypothesis~        -  Children with severe asthma receiving continuous levalbuterol will have a shorter~          duration of continuous therapy as compared to racemic albuterol.~      Secondary hypotheses~        -  Children receiving continuous levalbuterol will have improved lung function measured by~          forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol.~        -  Children receiving continuous levalbuterol will have improved clinical asthma score as~          compared to racemic albuterol.~   "
261689|NCT00124163|"~     Computed tomography (CT) colonography has gained widespread multi-disciplinary interest as an~     evolving noninvasive colorectal screening examination, with the potential of improved patient~     compliance. The investigator's prior work demonstrated that the bowel preparation was the~     least tolerable aspect of colorectal evaluation when compared to the CT colonography and~     optical colonoscopy procedures. Stool tagging could provide a more gentle and efficient bowel~     preparation, with fewer false positives due to retained stool-mimicking polyps.~      The researchers hypothesize that image quality and patient preference will vary with stool~     tagging concentration and dosing schedule. The researchers propose to evaluate specific stool~     tagging protocols with the following aims:~      AIM 1: Perform a randomized trial of three specific stool tagging protocols using barium and~     iodine at CT colonography in a well-characterized cohort of patients undergoing colorectal~     evaluation.~      AIM 2: Analyze the CT colonography and optical colonoscopy data to assess differences across~     stool tagging protocols for the outcome measures of patient preference, image quality in the~     presence of tagging, and diagnostic reader performance.~      The researchers will use specific variations in stool tagging techniques to determine the~     best image quality of CT data (e.g., homogenous tagging of fluid and stool), and highest~     patient acceptability, as well as evaluate the adequacy of preparation for same-day~     colonoscopy. Diagnostic reader performance will focus on the accuracy for detecting all~     neoplastic lesions including colon cancers, adenomatous polyps, sessile adenomas and flat~     adenomas. Most importantly, these results will help inform the design of a larger trial of an~     optimized CT colonography technique in a community setting.~   "
261694|NCT00124098|"~     The purpose of this study is to assess if Aranesp® administered once every 4 weeks to chronic~     kidney disease subjects is safe and efficacious in maintaining haemoglobin levels greater~     than or equal to 100 g/L.~   "
261695|NCT00124085|"~     This is a health services demonstration project that evaluates three methods of health care~     delivery for the management of individuals with symptoms of asthma. This study will evaluate~     the impact of a telephonic asthma disease management process, with and without a home~     intervention program, on preventing asthma-related morbidity through patient/family asthma~     education.~      The investigators' central thesis is that comprehensive clinical disease management protocols~     for the management of asthma will improve clinical outcomes; reduce fiscal resource~     consumption; and improve both patient satisfaction and patient quality of life. Additionally,~     individualized, in-home patient education and environmental assessment, when added to the~     telephonic protocol, will further improve these measures. However, incremental improvement~     will vary according to the population's access to care.~   "
261696|NCT00124072|"~     SEARCH is a randomised, double-blind, multi-centre United Kingdom (UK) trial of 12,064~     patients with myocardial infarction (MI) prior to study entry which aims to demonstrate~     whether a more intensive cholesterol lowering regimen using 80 mg simvastatin daily produces~     a larger and worthwhile reduction in cardiovascular events compared with a standard 20 mg~     daily regimen and whether reducing blood homocysteine levels with a daily dose of folic acid~     2 mg + vitamin B12 1 mg compared with matching placebo produces a worthwhile reduction in~     vascular disease.~   "
261697|NCT00124059|"~     The purpose of this study is to determine whether seroquel is effective in the treatment of~     type A and type B alcohol dependence.~   "
261698|NCT00124046|"~     The purpose of this study is to determine whether surgical section of the filum terminale in~     children, when added to standard medical therapy, will result in a reliable and~     clinically-significant improvement in two main markers of incontinence within/at 12 months~     after treatment.~   "
261699|NCT00124033|"~     This study is designed to assess whether a new technique called facilitated endoscopic~     retrograde cholangiopancreatography (ERCP) is or is not superior to conventional ERCP for~     removing stones found in the bile duct at the time of laparoscopic cholecystectomy. ERCP is~     an endoscopic procedure used to facilitate the radiological examination and subsequent~     manipulation of the common bile duct (eg. opening it up, which is called sphincterotomy).~     Both facilitated and conventional ERCP are performed as a separate procedure after the~     initial gallbladder surgery. This is a comparative study of these two techniques in a~     randomised clinical trial.~      The aim of this randomised clinical trial is to enable surgeons to decide whether placement~     of a plastic stent at the time of laparoscopic cholecystectomy will improve the success rate~     and safety of subsequent ERCP and sphincterotomy.~   "
261700|NCT00124020|"~     Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug,~     telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.~   "
261701|NCT00124007|"~     The purpose of this study is to determine the safety of and immune response to an~     investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational~     HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.~   "
261702|NCT00123994|"~     The aim of this study is to determine, in the framework of a randomized controlled clinical~     trial, whether Tai Chi can affect measurable improvements in self-reported outcomes such as~     pain, physical function and psychological well-being in people with osteoarthritis (OA)~     mainly affecting the hips or knees. The effectiveness of Tai Chi will be compared with both a~     non-intervention control group as well as with a formal exercise program, hydrotherapy.~     Hydrotherapy has long been considered an effective intervention for people with chronic OA~     although scientific evidence is weak at present. The main study hypotheses are that Tai Chi~     or hydrotherapy can significantly decrease pain and physical limitations; improve~     health-related quality of life; and promote psychological well being in patients with OA of~     the hip(s) or knee(s); and that Tai Chi and hydrotherapy are of equal efficacy.~   "
261703|NCT00123981|"~     Background: Coronary artery bypass grafting (CABG) can be performed either with or without~     the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The~     investigators hypothesize that CABG without the use of CPB may reduce the risk of~     perioperative death, stroke, myocardial infarction and other serious complications.~      The aim of the present study is to compare the incidence of complications and the clinical~     efficacy of CABG with and without the use of CPB in elderly patients.~   "
261704|NCT00123968|"~     The purpose of the study is to determine the safety of and immune response to an~     investigational HIV vaccine, VRC-HIVDNA016-00-VP, and a vaccine booster, VRC-HIVADV014-00-VP,~     in HIV uninfected adults from Kenya, Tanzania, and Uganda.~   "
261705|NCT00123955|"~     The purpose of this study is to examine whether spironolactone will improve exercise~     tolerance and quality of life in elderly patients with heart failure preserved ejection~     fraction (HFPEF).~   "
261706|NCT00123942|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) and~     safety and tolerability of MEDI-507 in patients with CD2-positive lymphoproliferative~     disorders.~   "
261707|NCT00123929|"~     After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer~     are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100~     mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain~     pathological response. They then receive the opposite drug, hormones, Herceptin, and~     radiation as indicated.~   "
261708|NCT00123916|"~     Evaluate if benznidazole, an antiparasite drug, given at a dose calculated as 5mg/kg/day for~     60 days, now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment -~     period adjusted according to the patient's body weight to a total minimum dose of 12g~     (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg) - reduces~     morbidity and mortality in patients with Chronic Chagas' Cardiomyopathy (CCC).~      The BENEFIT study is being conducted by the Population Health Research Institute (in~     Hamilton, Canada) and the Institute Dante Pazzanese de Cardiologia (Sao Paulo, Brazil)~     together with an independent Steering Committee.~   "
261709|NCT00123903|"~     This study was designed to determine whether COREG MR is more effective than TOPROL-XL in~     reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood~     pressure and microalbuminuria.~   "
261710|NCT00123890|"~     The purpose of this study is to determine eligibility for one of three treatment studies of~     the CCR5 antagonist GW873140 or an observational study without GW873140. No investigational~     treatment will be administered through this study.~   "
261711|NCT00123877|"~     The purpose of this early Phase II multicenter trial is to determine the objective clinical~     response to GPX-100, an anthracycline similar to doxorubicin, in up to 40 patients with newly~     diagnosed metastatic breast cancer. GPX-100 is unique among anthracyclines because it is not~     converted to doxorubicinol during metabolism in the body. This metabolite has been shown to~     be a major cause of damage to the heart (cardiotoxicity) in laboratory studies. Eligible~     patients who are enrolled in this study will receive GPX-100 as a single agent at the~     beginning of as many as 8 three week long cycles of chemotherapy. Objective measurements of~     tumor response will be made by computed tomography (CT) scans.~   "
261712|NCT00123864|"~     One of the side effects of standard radiation therapy for cancer of the nasopharynx is a~     permanent lessening of normal mouth moisture (saliva). This reduction in saliva is important~     because it causes a feeling of dry mouth, and has been shown to increase the risk of dental~     cavities and infections; change or decrease the ability to taste certain foods; and make~     chewing and swallowing food more difficult. Recent technical advances in radiation therapy~     offer the possibility of shielding a portion of one of the major salivary glands (parotid~     gland) from receiving a dose of radiation that would eliminate its ability to produce saliva,~     while still treating all sites of known cancer effectively. Recently, cancer researchers in~     Ann Arbor, Michigan used this new treatment technique to treat patients with head and neck~     cancers (but none with nasopharyngeal cancer), and found that patients treated in this manner~     still had significant saliva production from the spared gland. This study will try to use the~     treatment planning technique called intensity-modulated radiation therapy to protect a~     portion of one parotid gland while treating all known and suspected areas of cancer to full~     radiation doses.~   "
261713|NCT00123851|"~     This trial is designed to investigate the safety, tolerability and the effectiveness when~     OSI-774 (tarceva) is combined with oxaliplatin and capecitabine in treating patients with~     metastatic colorectal cancer.~   "
261714|NCT00123838|"~     The purpose of this study is to evaluate a non-ionizing electromagnetic method to align the~     prostate treatment site for radiation therapy and to monitor its position throughout~     radiation therapy delivery. The clinical study involves using an investigational device, the~     Calypso® 4D Localization System, and requires permanent implantation of three small sensors~     called Beacon® transponders in the prostate.~   "
261715|NCT00123825|"~     In the United States, the incidence of biliary tract cancer and gallbladder cancer has been~     estimated to be 6,000-8,000 patients per year. Currently, there is no standard therapy for~     these tumors once the disease has spread and is inoperable. Recent small studies with~     gemcitabine have shown a positive response rate. The investigators plan to test the~     combination of gemcitabine with cisplatin for biliary tract and gallbladder cancers.~   "
261716|NCT00123812|"~     Currently in Canada, and at the Cross Cancer Institute, the treatment of many women with~     breast cancer involves radiotherapy (RT). There is a complex process which takes place in~     order to plan the radiation therapy before patients commence their treatment. In many~     circumstances the investigators use computerized technology to assist in planning their~     treatment. This allows more precision in delivering the treatment to the desired areas and~     avoiding areas of normal tissue.~      Once the planning process is completed, the investigators then place marks with a marker pen~     on the skin of the patient to outline the area where the radiation will be delivered. The~     investigators confirm that the correct area is being treated with an x-ray taken on the~     treatment unit while the patient is in the treatment position. This is called a port film or~     verification film. The investigators then compare this to what they set up with the~     computerized data. If all the information matches, the patient is then treated for the full~     course of radiation, with the assumption that all treatments are given in the correct~     position. No further routine checking is done.~      The standard at some radiotherapy centers is that the patient treatment position is verified~     weekly by a portal film. At the Cross Cancer Institute the investigators normally only do it~     once at the beginning of treatment.~      No information is available to confirm the necessity of doing more frequent verification~     films, but in view of the very complex nature of the investigators' treatment delivery, it~     may be necessary to confirm the accuracy of their treatment more often.~      Over the course of a 4-5 week treatment the investigators know that some patients may lose~     weight, some become more relaxed after a few days, and some have trouble with the movement in~     their shoulders; all of these factors influence the positioning of the patient. Measurements~     taken on the treatment unit often change during the course of a patient's treatment, but no~     further verification is performed to ensure that the treated area is still what was initially~     intended. It is important from a quality assurance standpoint to see if more frequent~     checking of the radiation treatment set-up is indicated.~   "
261717|NCT00123799|"~     Breast cancer affects many women. One of the places to which it can spread is the lymph~     glands under the arm. The type of treatment offered to patients often will depend on whether~     those lymph glands have cancer in them or not. For this reason, a standard recommendation is~     that women with breast cancer have these lymph glands removed with surgery. This cancer~     causes side effects including numbness, pain, decreased ability to move the arm and arm~     swelling. A new type of surgery which looks only at the first gland that a cancer drains to~     (sentinel node biopsy) may help to avoid having to remove the glands under the arm. Also, a~     new way of imaging the glands under the arm called Positron Emission Tomography (PET)~     scanning may also give a better idea of the chance that these glands have cancer in them.~     This study is determining whether PET scans before surgery and sentinel node biopsy can~     decrease the need for a complete axillary dissection.~   "
261718|NCT00123786|"~     18F-fluorodeoxyglucose (18F-FDG) has been approved by many regulatory agencies world-wide and~     is in widespread use in the United States, Japan and Europe. In the United States, 18F-FDG~     scanning in oncology is approved for federal healthcare reimbursement for non-Hodgkin's~     lymphoma, Hodgkin's disease, colorectal cancer, lung cancer, oesophageal cancer, melanoma,~     head and neck cancer and breast cancer. It has general applications in all areas where~     abnormal glucose metabolism may be present including in circumstances such as differentiating~     the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour~     markers and normal imaging techniques; and assessing response to therapy where other~     techniques are deemed to be unhelpful. Current literature suggests that functional imaging~     with 18F-FDG Positron Emission Tomography (PET) may play an important role in the imaging~     evaluation of patients with soft tissue sarcoma, including guiding biopsy; detecting local~     recurrence at sites of tumour resection; detecting metastatic disease; predicting and~     monitoring response to therapy; and assessing for prognosis. In appropriate situations, it is~     possibly the most effective diagnostic strategy. However, due to the low incidence of these~     tumours, prospective studies with large multicenter patient groups will be essential to~     define the exact diagnostic role of 18F-FDG PET in this clinical setting.~   "
261749|NCT00123370|"~     The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks~     plus a tailored cognitive behavioural therapy program in the treatment of methamphetamine~     dependence.~   "
261719|NCT00123773|"~     Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses~     positron emitting radiolabeled tracer molecules to measure biological activity. The most~     common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to~     determine abnormal glucose metabolism in tumours and other sites. It has general applications~     in all areas where abnormal glucose metabolism may be present including in circumstances such~     as differentiating the tumour from scar tissue; evaluating the presence of the tumour in~     light of rising tumour markers and normal morphological imaging techniques; and assessing~     response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer~     Institute has recently been funded to establish a PET centre, and this study will evaluate~     the effectiveness, value and safety of PET scanning in a number of uncommon cancers in the~     Canadian health care environment.~   "
261720|NCT00123760|"~     Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses~     positron emitting radiolabeled tracer molecules to measure biological activity. The most~     common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to~     determine abnormal glucose metabolism in tumours and other sites. It has general applications~     in all areas where abnormal glucose metabolism may be present including in circumstances such~     as differentiating the tumour from scar tissue; evaluating the presence of the tumour in~     light of rising tumour markers and normal morphological imaging techniques; and assessing~     response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer~     Institute (CCI) has recently been funded to establish a PET centre, and this study will prove~     the effectiveness of PET scanning in the Canadian health care environment and validate the~     data that have been developed in other jurisdictions in specific oncologic indications.~   "
261721|NCT00123747|"~     At this time, computed tomography (CT) is the standard tool used at this institution for the~     staging of non-small cell lung cancer (NSCLC). For most patients, treatment planning for~     NSCLC is performed with the patient breathing freely during CT scanning. However, recent~     research has demonstrated that, by holding one's breath briefly, the NSCLC tumor mass can be~     held motionless. As a result, the tissue to be treated is better pinpointed and the area~     treated is significantly decreased through breath-hold planning. This allows for a higher~     dose of radiation to be given to the cancer. PET scanning is a promising newer imaging~     modality which has shown to be useful in staging NSCLC. This study hypothesizes that~     breath-held PET scanning and breath held-CT scanning will allow for more stringent~     radiotherapy plans, minimizing normal tissue toxicity, as well as potentially increasing the~     dose deliverable to the primary tumor.~   "
261722|NCT00123734|"~     The assessment of patients with suspected deep vein thrombosis (DVT) is a common clinical~     scenario that, despite major advances in diagnostic testing, continues to be challenging.~      The diagnosis of DVT remains problematic in:~        -  patients with suspected first DVT who have a moderate or high pre-test probability (PTP)~          for DVT and a normal compression ultrasound (CUS);~        -  patients with suspected recurrent DVT; and~        -  patients in whom CUS or contrast venography is technically difficult or not feasible due~          to patient characteristics.~      In patients with suspected first DVT who have a moderate or high PTP and a normal CUS, DVT~     occurs in up to 10% of cases. Thus, additional diagnostic testing is required, such as~     venography or serial CUS, so that DVT is not missed, but these approaches are costly and~     invasive.~      In patients with suspected recurrent DVT, currently used diagnostic approaches are~     problematic because they all have limitations in differentiating old disease from true~     recurrent disease.~      CUS is technically difficult in selected patients, particularly those who are obese.~      Contrast venography is the gold standard diagnostic test for DVT to which all other~     diagnostic venous imaging modalities for DVT are compared and judged. The Food and Drug~     Administration (FDA) requires that a new diagnostic test for DVT be assessed against~     venography.~      [99mTc] ThromboView® is a novel diagnostic test based on a 99mTc-labeled monoclonal antibody~     specific for D-dimer fragments of cross-linked fibrin that are found in acute DVT. After~     intravenous injection of [99mTc] ThromboView®, there is uptake of the monoclonal antibody by~     acute, D-dimer rich, venous thrombi. This is visualized with nuclear medicine imaging as an~     area of increased radioisotope activity that corresponds to the location of DVT.~      Based on the biologic and imaging characteristics of [99mTc] ThromboView®, this diagnostic~     test has the potential to:~        -  identify small non-occlusive proximal DVT or distal DVT in patients with a moderate or~          high PTP and normal CUS;~        -  differentiate old from new DVT in patients with suspected recurrent DVT;~        -  diagnose or exclude DVT in patients in whom CUS is not technically feasible; and~        -  provide an alternative to venography that is non-invasive, has no contrast-related~          toxicity and is easily administered.~      The present study is the first phase II clinical trial of [99mTc] ThromboView® in patients~     with suspected initial or recurrent DVT in whom DVT has been confirmed or excluded by~     venography. A phase II clinical trial to investigate the diagnostic accuracy of [99mTc]~     ThromboView® is justified because:~        -  ThromboView® was well tolerated, with no significant toxicity in studies involving~          animals and healthy volunteers; and~        -  it has shown promise in Phase I trials as a non-invasive diagnostic test for acute DVT.~   "
261723|NCT00123708|"~     This study will classify types of hypertonia in patients with cerebral palsy and determine if~     the classifications are reasonable in relation to the functional task of walking. Hypertonia~     is an abnormal increase in muscle tension. It is a common symptom of cerebral palsy that can~     lead to loss of function and deformity. This study may help scientists improve evaluation~     criteria for hypertonia and, ultimately, treatment results.~      Patients with cerebral palsy who are older than 6 years of age may be eligible for this~     study. Candidates are screened with a medical history and clinical evaluation.~      Participants are asked to walk in the lab while cameras record their movement. During this~     test, subjects wear a t-shirt and shorts with their arms and legs wrapped with a soft,~     rubber-like material. A piece of firm material is attached to the rubber sleeves and small~     plastic reflective balls are attached to the firm material. Balls may also be attached to the~     skin, using an adhesive. With the balls in place, the subject walks several times while~     cameras record the positions of the balls. In addition, small metal electrodes attached to~     the skin with an adhesive measure the electrical activity in the muscles.~      After the walking test is completed, subjects' leg muscle strength is measured with a special~     device while they perform three activities. First, they sit on a special chair with their leg~     and foot placed in an apparatus that measures their strength, then lie on their back, then on~     their stomach, and then stand on one foot holding a bar to balance during part of one~     activity. During the activities, their reflexes are tested, they are asked to move their~     legs, and their legs are moved for them.~   "
261724|NCT00123695|"~     There is increasing interest in myocardial abnormalities following central nervous system~     events, such as subarachnoid hemorrhage (SAH). These cardiac abnormalities include ECG~     changes, decreased cardiac output, decreased blood pressure, specific cardiac enzyme~     elevations, and segmental wall motion abnormalities (SWMA). Interestingly, wall motion~     abnormalities and ECG changes have shown to be reversible, and therefore the dysfunction has~     been described as neurogenic myocardial stunning.~      The pathophysiology of cardiac dysfunction following SAH has not yet been fully elucidated.~     Many reports (mainly case reports) have been published, but so far no study has investigated~     the frequency of these abnormalities in a prospective manner, have correlated the occurrence~     of the different cardiac abnormalities, and have assessed which clinical variables can~     predict cardiac dysfunction. And only a limited number of studies have related neurological~     outcome with cardiac dysfunction.~   "
261725|NCT00123682|"~     TeleQuit is a group randomized trial testing whether a telephone care coordination program~     increases the rate of smoking cessation treatment for VA patients at study sites. We are~     testing whether proactive care coordination (counselor initiates the call to the patient) is~     more effective than reactive coordination (coordinator waits for the patient to call); and~     whether multi-session counseling is more effective than brief primary care-based counseling~     plus self-help materials. We randomly assigned study sites to either quitline counseling or~     brief counseling only. All patients receive brief smoking cessation counseling from their~     primary care physician, smoking cessation medications (once they are in contact with the VA~     care coordinator), and a follow-up call at 6 months. Care coordination will be provided by VA~     clinical staff. Intensive counseling is provided by the California Smokers' Helpline.~   "
261726|NCT00123669|"~     The purpose of this study is to test the effect of primary progesterone on overall and~     disease free survival in women with operable breast cancer. The study addresses two issues~     related to breast cancer surgery:~        -  Circulating progesterone at the time of surgery might counteract the detrimental effect~          of estrogen on survival of women with operable breast cancer.~        -  Events at the time of surgery may have an impact on the natural history of breast cancer~   "
261727|NCT00123656|"~     Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be~     related to both allergies and acid reflux. There have been reports that both swallowed,~     aerosolized steroids and proton pump inhibitors have been effective treatments. The~     researchers propose to directly compare the efficacy of aerosolized fluticasone to~     esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized~     fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole~     (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for~     diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be~     randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks,~     subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires~     (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the~     patient at the first endoscopy and at the end endoscopy. The primary objective is to measure~     change in eosinophil infiltration of the esophagus in response to treatment of allergy~     (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.~   "
261728|NCT00123643|"~     The purpose of this study is to compare the vascular effects of two commonly used diabetes~     medications, rosiglitazone and glyburide in type 2 diabetic patients.~   "
261729|NCT00123630|"~     Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by~     dysphagia, food impaction or other obstructive esophageal symptoms in children and young~     adults.~      The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and~     family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic~     rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising~     incidence of EE may be related to the worldwide allergy and asthma epidemic.~      Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and~     topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have~     all been shown to be effective. However, none of these treatments are directed at the~     specific pathophysiologic mechanism of EE and some have significant side effects.~      The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies~     directed at asthma may also be effective for EE. Specifically those targeted at the allergic~     immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed~     anti-IgE antibody that has been shown to decrease the use of inhaled and oral~     corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related~     symptoms in patients with allergic asthma. The objective of the study is to determine the~     efficacy of omalizumab in the treatment of eosinophilic esophagitis~   "
261730|NCT00123617|"~     The study is designed to test the hypothesis that participation in a standard phase III group~     based cardiac rehabilitation programme will improve psychological morbidity, quality of life~     and cardiovascular risk factors, along with chest pain severity and frequency in women with~     cardiac syndrome X.~   "
261731|NCT00123604|"~     The purpose of this study is to compare the vascular effects of two commonly used blood~     pressure medications, carvedilol and metoprolol in hypertensive patients with type 2~     diabetes.~   "
261732|NCT00123591|"~     This trial is conducted in Asia, Europe, Middle East, and North America. The primary~     objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in~     patients with brain contusions. The secondary objective of the trial is to evaluate the~     preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic~     progression in contusive brain injury.~   "
261733|NCT00123578|"~     Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant. The number of~     individuals seeking treatment for GHB abuse has been steadily increasing in the United~     States. Currently, lorazepam and pentobarbital are two medications used to treat individuals~     who experience GHB-withdrawal symptoms. The purpose of this study is to describe the signs~     and symptoms of GHB withdrawal and to identify predictors of withdrawal severity. The study~     will also evaluate the safety and effectiveness of treatment with lorazepam versus~     pentobarbital for GHB detoxification.~   "
261734|NCT00123565|"~     The purpose of this study is to test whether SR123781A is a possible treatment for patients~     with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous~     coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of~     SR123781A are currently tested, each in a group of about 180 patients per group to find which~     is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.~   "
261750|NCT00123357|"~     Approximately 11,000 veterans annually are hospitalized with a newly acquired incident~     stroke. Based on American Heart Association ratios of stroke incidence and prevalence, up to~     80,000 veterans may be stroke survivors. The assessment of outcomes in stroke survivors is~     important for clinical practice and research, yet there is no consensus on the best measures~     of stroke outcome in either clinical practice or research. We have developed a new~     stroke-specific outcome measure, the Stroke Impact Scale (SIS), to capture physical function~     and other dimensions of health-related quality of life.~   "
261864|NCT00121849|"~     This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with~     a previous exposure to the Leishmania parasite (but without current or past history of~     leishmaniasis).~   "
261735|NCT00123552|"~     The purpose of this study is to compare different ways of treating uncomplicated malaria in a~     group of Ugandan children. The study will be divided into 2 parts. Part 1 of the study will~     consist of 600 children, ages 1-10, living in the Mulago III Parish of Kampala. Approximately~     90 children living in the same household as children from the Phase 1 portion of the study~     will be enrolled in Phase II of this study. Participants in Phase II of the study will~     receive an insecticide treated net to cover their bed. Over the course of the study,~     participants will be tested for malaria when they present to the clinic with a fever or~     illness. Participants that test positive for malaria will be given 1 of 3 possible study drug~     combinations. Study procedures will include physical exams and blood samples. Children will~     participate for about 3 years. Protocol 05-0110 is a study related to this protocol.~   "
261736|NCT00123539|"~     The purpose of this study is to test whether perioperative estrogen replacement in~     postmenopausal women reduces the risk for neurologic injury after coronary artery bypass~     graft (CABG) surgery.~   "
261737|NCT00123526|"~     This study will evaluate the effectiveness of an environmental worksite intervention to~     reduce obesity among hospital employees.~   "
261738|NCT00123513|"~     The purpose of this study is to design a comprehensive nutrition and physical activity~     strategy to gain a broad understanding of the social and cultural role of food and physical~     activity among workers. Perspectives on innovative interventions that are socially feasible~     and culturally acceptable will also be obtained. Health lifestyle promotion interventions~     addressing portion control, healthy nutrition, and increasing physical activity will be~     tested.~   "
261739|NCT00123500|"~     The goal of the project is to develop, implement, and evaluate, through a randomized~     controlled trial at a worksite, an intervention to promote increased physical activity~     behavior and healthier eating behavior to reduce overweight and obesity among elementary~     school personnel.~   "
261740|NCT00123487|"~     This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in~     accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome~     positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib~     mesylate (Gleevec).~   "
261741|NCT00123474|"~     This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia~     chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant~     to imatinib mesylate (Gleevec).~   "
261742|NCT00123461|"~     The purpose of this study is to demonstrate the safety and effectiveness of Hectorol®~     (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney~     disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal~     range. Previous studies with doxercalciferol were conducted in patients who had low levels of~     vitamin D.~   "
261743|NCT00123448|"~     This study will determine if the type of gesture, increased quantity of an image, and the~     number of times a face is shown repeating a gesture bring about activation in the mirror~     neurons. Researchers aim to learn about which areas of the brain are necessary to perform~     certain cognitive tasks-that is, relating to a person's thinking or remembering-especially~     visual and motor tasks. Because one way humans learn is by imitation, a mechanism is required~     to transfer the behavior the person adopts from others through observation. This type of~     learning could be based on a mechanism similar to that provided by mirror neurons. From~     previous studies it has been learned that the observation of hands and mouths has brought~     about the most effective ways of activating the mirror neurons.~      Patients ages 21 to 55 who are in good health, are right handed, are not pregnant, and are~     native speakers of English may be eligible for this study. There will be about 24~     participants.~      Patients will undergo a magnetic resonance imaging (MRI) scan. Before the scan, they will~     complete a safety questionnaire about the presence of any metal in their bodies. Patients are~     at risk for injury from the MRI magnet if they have pacemakers, dental implants or other~     devices. Female patients will undergo a pregnancy test. The technique MRI uses includes a~     strong magnetic field and radio waves to obtain images of body organs and tissues. During the~     initial MRI scan, patients will lie still on a table that will slide into the enclosed tunnel~     of the scanner. They will be in the scanner for about an hour. During the procedure, they may~     be asked to lie as still as possible for up to 20 minutes at a time. As the scanner takes~     pictures, patients will hear knocking or beeping sounds. Each participant will wear earplugs~     to reduce this noise. They will be able to communicate with the MRI staff at all times during~     the scan, and they may ask to be removed from the machine at any time. The functional MRI~     (fMRI) scan will involve taking pictures of the brain while patients are performing tasks.~     All the tasks will be explained, and patients will have the chance to practice them before~     entering the scanner. During the fMRI, patients will view short film segments of people~     making gestures. Before and after the scan, patients will be asked to complete several short~     questionnaires. The testing sessions will take a total of about 2 hours.~      Participants will receive compensation for their time and inconvenience, with a maximum~     payment of $200. This study will not have a direct benefit for participants.~   "
261744|NCT00123435|"~     The objective of this study is to determine whether a tailored web-based system for providing~     feedback on walking step-counts, in combination with regular nutrition counseling, can~     improve weight loss over nutrition counseling alone in patients with heart disease.~   "
261745|NCT00123422|"~     The purpose of this study was to compare the effect of exercise treatment combined with~     breathing retraining (a computerized feedback program), with exercise treatment combined with~     heliox (a helium and oxygen combination), with exercise only in patients with moderate to~     severe chronic obstructive pulmonary disease. This was an 8-week intervention study.~   "
261746|NCT00123409|"~     The aim of this study is to test for improvements in treatment outcomes for primary care~     patients with at-risk drinking when cared for using telephone disease management (TDM)~     compared to those treated with usual care. Based on our pilot data, TDM for at-risk drinking~     may be a viable method for reducing alcohol consumption in this population.~      Hypotheses: The hypotheses for this research plan are: 1. A significantly greater proportion~     of patients assigned to TDM will obtain improvement in drinking outcomes compared to usual~     care. 2. TDM will lead to greater access to behavioral health care and higher intensity of~     treatment relative to usual care. This effect will be moderated by logistics such as~     transportation problems, physical functioning, and employment status. 3. More patients~     assigned to TDM will receive guideline adherent care.~   "
261747|NCT00123396|"~     Our 4-year project uses public domain software and content developed by a University of~     Alabama at Birmingham (UAB) team and updates, refines, and tailors it to the unique clinician~     populations and electronic educational applications of VAMCs We are testing an innovative,~     web-based intervention adapted specifically for the VA to increase syndromic recognition,~     treatment, and post-exposure prophylaxis of biological warfare agents at multiple VA sites~     via a randomized controlled trial (RCT). Ultimately, we will disseminate the intervention~     throughout the entire VA system.~   "
261748|NCT00123383|"~     The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks~     plus a tailored cognitive behavioural therapy program in the treatment of cocaine dependence.~   "
261751|NCT00123344|"~     Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with~     substantial morbidity and mortality. Present treatment strategies are aimed at termination of~     AF and prevention of AF recurrence using antiarrhythmic drugs or heart rate control drugs.~     Drugs are not always well tolerated, so atrial pacing as a strategy for prevention of atrial~     tachyarrhythmias is being explored.~      The AT501 pacemaker has both prevention and treatment algorithms for atrial~     tachyarrhythmias. The investigators wish to determine whether these special features, over~     the long term, decrease the amount of time the person experiences AF.~   "
261752|NCT00123331|"~     Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine~     medication was addressed. Current therapeutic approaches include cyclosporine reduction or~     discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a~     beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?~      Study Design: Heart transplant patients with a moderate degree of renal failure on low dose~     cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine~     and initiation of rapamycin immunosuppression.~      Read-Out: Renal function after 6 months; tolerability; and safety were assessed.~   "
261753|NCT00123318|"~     The purpose of this study is to determine the side-effects and effectiveness of a new type of~     chemoradiotherapy treatment for patients who have had surgery for stomach cancer. The~     treatment uses epirubicin, cisplatin, and 5-fluorouracil (ECF) chemotherapy together with~     radiotherapy.~   "
261754|NCT00123305|"~     The primary purpose of this study is to evaluate the safety and preliminary efficacy of~     microplasmin when administered intravenously to patients who have suffered an acute stroke~     within 12 hours before randomization.~   "
261755|NCT00123292|"~     The purpose of the trial is to evaluate the safety and efficacy of microplasmin~     administration in patients with acute peripheral arterial occlusion.~   "
261756|NCT00123279|"~     The purpose of this trial is to evaluate the safety and preliminary efficacy of different~     doses and several exposure times of intravitreal microplasmin in the setting of pars plana~     vitrectomy for vitreomacular traction maculopathy.~   "
261757|NCT00123266|"~     The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to~     open blocked arteries to the brain in patients with acute stroke when given into the artery~     at the site of the blockage.~   "
261758|NCT00123253|"~     HIV lipodystrophy affects a significant proportion of patients treated with combination~     antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and~     loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin~     resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily~     administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with~     an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral~     adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous~     adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2~     mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess~     of abdominal fat accumulation.~   "
261759|NCT00123240|"~     The purpose of this study is to compare the ability of low calorie high carbohydrate and low~     calorie high fat/protein diets to decrease abdominal fat in overweight and obese subjects.~     The investigators will also test the effects of these diets on secondary outcomes including~     body composition, fluid and electrolyte balance, lipids and lipoproteins, blood pressure,~     arterial compliance, glucose and insulin metabolism, bone turnover, and measures of satiety.~   "
261760|NCT00123227|"~     The purpose of this study is to determine whether rosiglitazone, a peroxisome proliferator~     activated receptor gamma (PPAR-gamma) agonist, induces regression in carotid atherosclerotic~     plaques in diabetic patients with vascular disease and/or hypertension over a 12 month~     period.~   "
261761|NCT00123214|"~     The purpose of this study is to determine whether or not a low calorie, low glycemic index~     diet with omega-3 fatty acid supplements can prevent some of the negative consequences of~     sleep deprivation.~   "
261762|NCT00123201|"~     The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI~     for the acute treatment of moderate to severe migraine headache.~   "
261763|NCT00123188|"~     The investigators hypothesize that endometrial thickness will be a significant predictor of~     endometrial hyperplasia in a postmenopausal female population with metabolic syndrome:~     diabetes and/or insulin resistance, hypertension, and obesity.~   "
261764|NCT00123175|"~     The purpose of this research is to determine the effectiveness of the intrauterine device~     (IUD) called Mirena when compared to the Provera tablets used in treating this condition.~   "
261765|NCT00123162|"~     The primary hypothesis is that a 100mg single dose of sildenafil citrate (Viagra) will have a~     higher improvement rate when compared to placebo in the treatment of moderate to severe~     primary dysmenorrhea.~   "
261766|NCT00123149|"~     The purpose of this study is to evaluate the long-term safety profile of epoetin alfa in~     patients with anemia of chronic disease due to rheumatoid arthritis~   "
261767|NCT00123136|"~     The researchers will study the application of a commercial pulsed magnetic stimulating device~     to the feet of patients with moderate-severe foot pain secondary to diabetic peripheral~     neuropathy (DPN).~   "
261768|NCT00123123|"~     Recent studies have found that poor oral hygiene may foster the colonization of the~     oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care~     unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent~     ventilator-associated pneumonia (VAP).~      The specific aims of this investigation are: 1) to organize the necessary infrastructure to~     develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to~     prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if~     the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque,~     oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.~   "
261769|NCT00123110|"~     The purpose of this research study is to determine if a relationship between insulin~     resistance (IR) and testosterone (T) exists in women who have already gone through menopause.~   "
261770|NCT00123097|"~     The purpose of this study is to evaluate a new rubber material used to make prosthetic~     replacements of the face lost to cancer, trauma, or birth defects.~   "
261771|NCT00123084|"~     The purpose of the research study is to determine the effects of two different kinds of~     speech treatment on certain behaviors in individuals with parkinson's disease. These~     behaviors include speech, voice, related communication behaviors, swallowing and body~     movement.~   "
261772|NCT00123071|"~     This observational study will provide data (variations in ventricular size and function) that~     are essential to designing and conducting clinical trials. In addition, the study will~     evaluate intra- and inter-study variability seen in echocardiography.~   "
261773|NCT00123058|"~     The purpose of this study is to improve adherence to blood pressure (BP) monitoring and~     medication compliance in individuals with high BP.~   "
261774|NCT00123045|"~     To test the efficacy of a patient-centered, culturally tailored education and activation~     intervention designed to improve adherence to medication and life style recommendations among~     adults with uncontrolled hypertension.~   "
261775|NCT00123032|"~     The purpose of this study is to prevent excessive weight gain among kindergarten and first~     grade American Indian children using improved diet and increased physical activity at home~     and at school.~   "
261776|NCT00123019|"~     The purpose of this study is to increase physical activity, improve diet, and reduce obesity~     of hotel employees.~   "
261777|NCT00123006|"~     The purpose of this study is to test the effects of the DASH diet in patients with isolated~     systolic hypertension.~   "
261778|NCT00122993|"~     The purpose of this study is to implement and evaluate a two-year multi-component~     environmental intervention to prevent weight gain among city bus drivers at four bus garages.~      It is hypothesized that transit employees in the intervention garages will gain less weight~     compared to the transit employees in the control garages.~   "
261779|NCT00122980|"~     The purpose of this study is to compare standard therapy (transfusions and chelation) with~     alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and~     management of iron overload in children with sickle cell anemia (SCA).~   "
261780|NCT00122954|"~     This study will determine whether fish oil can reduce depression in people with multiple~     sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant~     medication.~      Study hypothesis: Three months of fish oil supplementation will improve depression scores on~     the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI)~     better than placebo.~   "
261781|NCT00122941|"~     Micronutrient deficiencies are common in HIV infected children and are aggravated by poor~     nutrition, especially in poor resource countries such as Uganda. It appears that~     micronutrient deficiencies contribute to immune dysfunction, increased morbidity and HIV~     disease progression. Hitherto, there has been no randomised controlled trial to assess the~     effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected~     children in Africa. Therefore, the investigators shall carry out a randomised controlled~     trial to determine the effect of multiple micronutrient supplementation on morbidity, weight~     gain and mortality among HIV infected children aged 1 to 5 years in Uganda.~      Hypothesis: Daily administration of twice the recommended dietary allowance (2RDA) of~     multiple micronutrients to HIV infected children aged one to five years, for 6 months, will~     reduce all cause mortality from 24% to 14.4% in one year and result in a weight gain~     difference of 150 grams.~   "
261782|NCT00122928|"~     The purpose of this study is to design and demonstrate the feasibility of implementing~     moderate and intensive environmental obesity prevention programs at major worksites.~   "
261783|NCT00122915|"~     The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex~     Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc,~     Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central~     post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.~   "
261784|NCT00122902|"~     This study is assessing the extent of spirituality in patients with HIV/AIDS and will~     determine the relationship between spirituality, health status, and the will to live.~   "
261785|NCT00122889|"~     This study will determine whether garlic supplements affect the way certain drugs are~     processed in the body.~   "
261786|NCT00122876|"~     The purpose of this study is to determine whether the Litx™ treatment is safe and effective~     in treating inoperable hepatocellular carcinoma (HCC).~      Litx™ is an integrated treatment system comprising an intravenously administered~     photosensitizing agent, Talaporfin Sodium (LS11), that is activated by non-coherent light~     generated inside the tumor by an implanted light emitting diode (LED) array light source.~   "
261787|NCT00122863|"~     This is a clinical trial assessing the time to relapse of anxiety symptoms among patients~     with generalized anxiety disorder who have responded to duloxetine therapy.~   "
261788|NCT00122850|"~     This study will examine duloxetine compared with placebo and an active comparator in the~     treatment of generalized anxiety disorder.~   "
261789|NCT00122837|"~     This is a clinical trial assessing duloxetine and comparator to placebo in patients who have~     generalized anxiety disorder.~   "
261790|NCT00122824|"~     This is a clinical trial assessing duloxetine compared with placebo in patients who have~     generalized anxiety disorder.~   "
261791|NCT00122811|"~     The purpose of this study is to assess the benefits and risks of treating very elderly (those~     aged 80 or older) individuals with hypertension.~   "
261792|NCT00122798|"~     The investigators implemented a structured chain of acute stroke care with early integrated~     rehabilitation. The mortality at 6 months was lower (12%) compared to 23% in the~     International Stroke Trial (IST) and 39% (67%) of the patients were dead or dependent, which~     is superior compared to international data.~   "
261793|NCT00122785|"~     The purpose of this study was to determine whether a single intramuscular injection of~     dexamethasone decreased the duration of symptoms of acute bronchiolitis in young children.~   "
261794|NCT00122772|"~     The purpose of this trial is to study clinical effects of two/four high dose rate (HDR)~     brachytherapy applications and teletherapy with or without weekly cisplatin in cervix cancer.~   "
261807|NCT00122603|"~     The purpose of this study is to evaluate virological efficacy and safety of two double~     protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg~     twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease~     inhibitor naive HIV-1 patients.~   "
261795|NCT00122759|"~     -  Adequate sedation is of paramount importance to avoid stress and pain in mechanically~          ventilated patients. It is usually achieved by infusing sedatives (benzodiazepine) and~          analgesic (opiate) drugs.~        -  This combined sedation may not be sufficient in some instances.~        -  The aim of this study is to evaluate whether addition of a third substance, ketamine,~          allows the achievement of better sedation and avoids the use of neuromuscular blocking~          agents.~   "
261796|NCT00122746|"~     The researchers plan:~        -  To undertake clinical studies of radiotherapy with or without the administration of the~          chemotherapeutic agent cisplatin, known to be a radiosensitizer;~        -  To perform pre-clinical studies of the radiosensitivity of human fibroblasts and~          cervical cancer cell lines in culture, with or without the addition of various HIV~          proteins or protease inhibitors, in order to determine the extent of any cellular~          radiosensitizing properties of these molecules;~        -  To develop strategies for sensitizing tumour cells to radiation, specifically by~          down-regulating specific viral proteins that are known to be factors associated with~          resistance to radiotherapy.~   "
261797|NCT00122733|"~     Patients may be very agitated during the weaning period from mechanical ventilation.~     Administration of loxapine, a neuroleptic that does not notably affect ventilatory drive, may~     help in obtaining an adequate level of cooperation and, therefore, in reducing the duration~     of mechanical ventilation.~   "
261798|NCT00122720|"~     The study is investigating whether randomization to perioperative darbepoetin alfa treatment~     improves the rehabilitation following surgery for colonic and rectal cancer.~   "
261799|NCT00122707|"~     The purpose of this study is to compare the mechanical and infectious complications of~     peripheral versus central venous catheters in critically ill patients. Group allocation will~     be performed by randomization.~   "
261800|NCT00122694|"~     The purpose of this study is to determine whether carbon monoxide is effective in the~     treatment of stable COPD.~   "
261801|NCT00122681|"~     Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and~     genitals in men and women. Several types of HPV infection are transmitted by sexual activity~     and, in women, can infect the cervix (part of the uterus or womb). This infection often goes~     away by itself, but if it does not go away (this is called persistent infection), it can lead~     in women over a long period of time to cancer of the cervix. If a woman is not infected by~     HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the~     efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated~     cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in~     young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study~     subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine)~     administered intramuscularly according to a 0-1-6 month schedule.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
261802|NCT00122668|"~     The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1~     infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor~     (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor~     (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI~     plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed~     tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).~   "
261803|NCT00122655|"~     The aim of this trial is to evaluate the impact on fat distribution of switching to~     NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral~     suppression.~      Maintenance of virological suppression and immunological factors are also assessed.~   "
261804|NCT00122642|"~     In modern-day medicine, the use of central venous catheters has become unavoidable. However,~     their use does not come without risk. It puts patients in danger of infectious complications~     (catheter-related infections [CRI]), the most important of which is catheter-related~     bloodstream infection (CRBSI). CRBSI is associated with a significant increase in hospital~     stay and, therefore, cost of patient management, morbidity, and probably also mortality.~     There still is an urgent need for effective, cheap and easy to implement measures to prevent~     CRI that are without risk of developing antibiotic resistance.~      During use, bacteria can colonize the inner surface of the catheter. This endoluminal route~     of infection can be prevented to some extent when an antibiotic solution is instilled in the~     catheter for a long enough time and on a regular basis. However, to avoid resistance from~     occurring, the use of antibiotics for infection prevention should remain exceptional.~      The use of a non-toxic antiseptic might be a better alternative. Recently, the use of an~     alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility~     of polyurethane and silicone catheters submerged in an alcohol solution was publicized with~     no biomechanical or structural changes detected after 9 weeks of immersion. The major~     advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the~     risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic~     lock, the development of antibiotic resistance is not of concern. Furthermore it would be~     cheap and universally available.~      In this randomised study, the efficacy of a 70% alcohol lock solution for the prevention of~     CRBSI will be compared with placebo when applied for 15 minutes per day.~   "
261805|NCT00122629|"~     Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to~     increase sustained virological response (SVR) rates in HCV non-responders to a standard~     interferon/ribavirin combination.~      Patients with hepatitis C virus infection were eligible if they had failed to respond to a~     single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was~     defined as persistent HCV RNA in the serum during the last month of treatment.~      This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and~     amantadine or a placebo for 48 weeks.~   "
261806|NCT00122616|"~     The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with~     liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus~     failed. This scientific proof needs a comparative study to be done including two groups of~     patients randomly allocated: one with the treatment (peginterferon) and the other without any~     treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed;~     one before the study and a second 2 years after.~   "
271143|NCT00037336|"~     To test the theory that accelerated inflammation-promoted atherosclerosis occurs in patients~     with rheumatoid arthritis (RA).~   "
261808|NCT00122590|"~     This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring,~     from weeks 2 to 24, after the initiation of HAART including either indinavir/r, lopinavir/r~     or the new 625 mg formulation of nelfinavir twice-a-day (bid). If trough concentrations were~     out of the range given for each protease inhibitor (PI), the PI dose was adjusted.~   "
261809|NCT00122577|"~     This trial is aimed at studying the antiviral activity, toxicity and pharmacokinetic (PK)~     interactions of tenofovir DF and atazanavir enhanced with low dose of ritonavir given alone~     and then concomitantly as part of a salvage regimen to HIV patients with multiple failure,~     under conditions allowing to tease out the specific role of atazanavir combined with low dose~     of ritonavir.~   "
261810|NCT00122564|"~     It is probable that a mucosal approach is necessary for a prophylactic HIV vaccine protecting~     against sexually transmitted infection. Mucosal immune responses have been almost~     non-existent in trials of HIV vaccine candidates in which the antigen was delivered~     systemically. This study will test the safety and immune response of a recombinant HIV-1gp160~     by nasal and mucosal routes alone or formulated with DC-Chol in healthy volunteers.~   "
261811|NCT00122551|"~     Although lifelong continuous therapy with HAART remains the standard of care of HIV~     infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and~     provide substantial decline in HIV-related morbidity and mortality, long-term toxicity~     associated with antiretroviral therapy is a real concern. The purpose of this study is to~     compare an intermittent therapy strategy to a continuous treatment in patients with chronic~     and well controlled HIV-1 infection.~   "
261812|NCT00122538|"~     The purpose of this study is to try a known antiretroviral combination in HIV- infected~     children with only one intake a day, in order to simplify the prescription and improve~     adherence to treatment. This is what is called a phase II clinical trial, only recruiting and~     following a small number of children (50) during one year to evaluate the quantity of drug in~     the blood just before it is taken and one to three hours after it is taken. The other~     important objective is to study the tolerance of drugs in that mode of prescription of the~     triple combination.~   "
261813|NCT00122525|"~     Observational studies suggest that male circumcision may provide protection against HIV-1~     infection. A randomized, controlled, intervention trial was conducted in a general population~     of South Africa to test this hypothesis.~   "
261814|NCT00122512|"~     This Phase 2a study involving Tenofovir Disoproxil Fumarate (TDF) will provide extended~     safety data for high-risk men. Secondarily, the study will assess the feasibility of~     conducting the trial and evaluate the preliminary effectiveness of TDF 300 mg as an HIV~     prevention method when taken once a day.~   "
261815|NCT00122499|"~     This study has been designed to evaluate the efficacy and safety of a 20-mg dose of tadalafil~     administered “on demand” to patients with erectile dysfunction (ED) after external-beam~     radiotherapy (EBRT) of prostate cancer.~   "
261816|NCT00122486|"~     This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended~     safety of TDF 300 mg per day among young women who are not HIV-infected.~   "
261817|NCT00122473|"~     The purpose of this study is to determine whether imatinib is effective in the treatment of~     primary and recurrent dermatofibrosarcoma protuberans (DFSP).~   "
261818|NCT00122460|"~     The purpose of this trial is to investigate the efficacy of cetuximab in combination with~     chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic~     head and neck cancer. Overall survival will be taken as the primary measure of efficacy.~   "
261819|NCT00122447|"~     The purpose of this study is to determine whether cardiovascular disease (CVD) risk markers,~     β-cell function, and insulin sensitivity can be improved by targeting mechanisms of both~     diabetes and CVD - using an antioxidant, an angiotensin II receptor blocker (ARB), or an~     anti-inflammatory agent - in patients with impaired glucose tolerance (IGT) in a randomized,~     controlled trial.~   "
261820|NCT00122434|"~     The primary objective of this study is to determine the optimum dose of BEA 2180 BR~     inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in~     patients with COPD.~   "
261821|NCT00122421|"~     The goal of this study is to investigate a comprehensive provider-focused intervention to~     improve the quality of care for diabetic patients in a large primary care practice at Brigham~     and Women's Hospital. This will be accomplished through pharmacist recommendations provided~     to primary care providers prior to routine scheduled office visits for diabetic patients.~   "
261822|NCT00122408|"~     The objective of this study is to assess the effects of a daily enteral supplementation with~     probiotics within a population of critically ill, mechanically ventilated patients.~     Especially, the effects of probiotics on mortality rate in intensive care medicine will be~     analysed.~   "
261823|NCT00122395|"~     The purpose of this study is to compare the safety, acceptability and ease of the~     administration of two screening methods, a pen and paper questionnaire and an audiotape with~     headsets, for screening for intimate partner violence in a pediatric emergency department~     (ED).~   "
261824|NCT00122382|"~     This is a world wide study to evaluate the remission and joint damage in subjects treated~     with abatacept in addition to methotrexate versus subjects who receive methotrexate along~     with a placebo.~   "
261825|NCT00122369|"~     Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing~     breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well~     functioning individuals. Unabated stress during an invasive procedure not only interferes~     with smooth progression of the ongoing procedure, but can also have deleterious effects when~     patients need additional procedures and dread recurrent medical traumatization. The long-term~     objective of this research is to provide patients with a simple coping strategy at the~     vulnerable time of large core biopsy in the hope that this behavioral intervention will carry~     over to recovery and future medical procedures. In the largest prospective randomized study~     of its kind, the researchers showed that a self-hypnotic intervention during percutaneous,~     image-guided vascular and renal interventions resulted in less pain and anxiety, greater~     hemodynamic stability, and fewer procedure interruptions. The positive effects of the short~     initial hypnotic intervention, which was structured in the procedure room, became more~     pronounced the longer the procedure lasted and carried over into the immediate post-procedure~     recovery. The investigators therefore challenge the current paradigms that long-lasting~     effects require intensive presurgical preparation.~   "
261826|NCT00122356|"~     The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in~     preventing bone loss in postmenopausal women with early breast cancer who are receiving~     anastrozole therapy, and to determine how long alendronate treatment is needed.~   "
261827|NCT00122343|"~     This is an open-label nonrandomized multi-center study designed to evaluate the effect of~     AP23573 in patients with recurrent or persistent endometrial cancer. The primary objective is~     to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer~     when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5~     mg/day.~   "
261828|NCT00122330|"~     The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion~     dependent patients with hemolytic PNH.~   "
261829|NCT00122317|"~     The purpose of this study is to evaluate the long-term safety of eculizumab in patients with~     transfusion dependent hemolytic PNH.~   "
261830|NCT00122304|"~     The primary objective is to evaluate the safety of eculizumab in patients with~     transfusion-dependent hemolytic PNH~   "
261831|NCT00122291|"~     The purpose of this trial is to study the efficacy of preoperative radiation therapy and~     capecitabine in locally advanced rectal cancer.~   "
261832|NCT00122278|"~     Migraines are a specific type of headache that frequently recur and are very painful.~     Although there are many medications that are effective against migraines, none of these~     medications cure 100% of migraines. Another problem with migraines is that although many~     times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3~     of the time migraines recur the next day. The purpose of this research project is to see if~     adding a medication called dexamethasone to standard ER therapy will help patients get better~     quicker and stay pain-free more often than if they receive placebo.~   "
261833|NCT00122265|"~     Prostate cancer is the most common malignancy in males, and radiotherapy is a commonly chosen~     treatment option for patients with localized disease. Technical innovations such as~     three-dimensional conformal radiotherapy (3D CRT) and intensity-modulated radiotherapy permit~     radiation dose escalation and possibly better disease outcomes, but escalated doses may be~     accompanied by long-term complications. This study will examine, for the first time, the~     independent contribution of a patient's own genetic makeup to the development of~     post-radiation complications, permitting the future development of predictive tests to avoid~     radiation injury. To do this, the investigators will examine gene markers and blood proteins~     in a series of approximately 100 prostate cancer survivors who have received~     three-dimensional conformal radiotherapy between 1996 and 2000 at the Cross Cancer Institute.~   "
261834|NCT00122252|"~     The clinical outcome after external beam irradiation for prostate cancer is disappointing in~     the advanced tumor stages. There are indications that an increase in radiation dose to the~     tumor will improve outcome significantly, especially to the biologically active tumour parts~     within the cancer area. Until recently no imaging equipment was available to define both the~     anatomic and biologically active tumor parts. Now, at the Center for Biological Imaging and~     Adaptive Radiotherapy, equipment is at hand that will be able to visualise the areas~     mentioned above. When combining the data of these imaging modalities it might be possible to~     create an optimised irradiation plan. This study is a planning study in which, on 15~     patients, the different anatomical and biological imaging data per patient will be evaluated,~     matched and finally a theoretical improved irradiation treatment plan will be made. This~     research complies with the current opinion on radiation development. Progress in functional~     imaging is likely to provide the tools required for individualised risk-adapted radiotherapy.~   "
261835|NCT00122239|"~     This study will examine, for the first time, the independent contribution of a patient's own~     genetic makeup to the development of post-radiation complications, permitting the future~     development of predictive tests to avoid radiation injury. To do this, the investigators will~     examine gene markers in a series of breast, prostate, brain and lung cancer survivors who~     have received conformal radiotherapy between 1996 and 2003 at the Cross Cancer Institute and~     Tom Baker Cancer Centre.~   "
261836|NCT00122226|"~     This is a randomized prospective study into metabolic adverse events during different types~     of initial antiretroviral therapy in HIV-1-infected men.~   "
261837|NCT00122213|"~     Advancing age in itself is associated with changes in body composition. However, during~     transitional life stages, such as retirement, detrimental changes on diet and physical~     activity may occur. This might lead to weight gain and accumulation of abdominal fat.~      To prevent these changes, participants receive a low-intensity intervention on energy balance~     and related behaviours.~      After six months, one and two years, the effects will be studied by comparing the~     intervention group with the control group.~   "
261838|NCT00122187|"~     Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United~     States. Results from randomized clinical trials and intervention studies have suggested that~     implementation of a CRC screening program for men and women over age 50 results in reduced~     CRC mortality. However, for this reduction to be fully realized, it is imperative that all~     positive screening tests are followed by complete diagnostic evaluation (CDE). Numerous~     intervention programs have been used to improve initial CRC screening rates, but data~     indicate that outside the research setting, less than half of patients with a positive fecal~     occult blood test (FOBT) screening result undergo CDE. To enhance the translation of this~     best practice recommendation to clinical practice, the investigators propose to implement an~     electronic event notification intervention (CRC-ENS) directed at making physician and system~     level changes to increase the proportion of patients with an abnormal FOBT that undergo CDE.~   "
261839|NCT00122174|"~     Although family caregivers perform an incredibly valuable service for their relatives and the~     formal health care system, they do so at a considerable cost to themselves both emotionally~     and physically. Effective stress management techniques can: 1) help to decrease the~     caregivers' feelings of burden and stress; 2) improve the emotional and physical health of~     caregivers; and 3) empower caregivers to gain control of their lives.~   "
261840|NCT00122161|"~     Clinical trial of implementation of clinical practice guidelines for managing hypertension in~     primary care clinics.~   "
261841|NCT00122148|"~     This is a pilot study to first measure the cross-sectional relationship between variations in~     physicians� vignette scores and aggregated scores of individual physicians� patient health~     outcomes; and second to (longitudinally) determine whether feedback of vignette scores~     improves physicians� clinical performance as measured by vignettes~   "
261842|NCT00122135|"~     The goal of this research agenda is to improve the quality of end-of-life care by explicitly~     identifying values that will guide the decision-making process, with a particular emphasis on~     the role of ethnic, racial and cultural factors.~   "
261843|NCT00122122|"~     Complications resulting from medications, or adverse drug events (ADEs), are prevalent and~     are a major source of excess morbidity and costs. ADEs are particularly problematic in older~     patients because of their higher burden of comorbidity and diminished physiologic reserve. In~     addition, older patients are more likely to be exposed to polypharmacy, a major risk factor~     for ADEs. While ADEs may be idiosyncratic, many result from medical errors and inadequate~     systems for ensuring the safe and effective use of medications.~      The goal of the proposed study is to test the efficacy of a potentially potent intervention~     to improve the use of medications in older outpatients enrolled in VA primary care clinics.~     The intervention-Enhanced Pharmacy Care-involves a formal, multi-dimensional evaluation of~     patients� medication regimens by a trained clinical pharmacist and board-certified~     geriatrician.~   "
261844|NCT00122109|"~     Telemedicine has the potential to profoundly influence the delivery of specialized care to~     the remote veteran population suffering with PTSD. Preliminary research supports telemedicine~     technology as a possible solution to improve access to mental health services for veterans~     with PTSD. The proposed research is a treatment-outcome study that will assess the clinical~     efficacy of conducting an Anger Management Therapy (AMT) group treatment intervention using a~     videoteleconferencing (VTC) modality as compared to the traditional in-person modality with~     veterans who have PTSD and reside in remote locations on the Hawaiian Islands. AMT is a~     manual-guided cognitive-behavioral, skill based group intervention that has been used~     nationwide in VA substance abuse programs and most recently has been adopted by many VA PTSD~     Clinical Teams to treat anger-related to the sequelae of PTSD.~   "
261845|NCT00122096|"~     Surgery initiates a complex cascade of events involving the release of chemical compounds~     from nerve endings and damaged tissue which leads to an inflammatory and pain response. The~     purpose of this investigation is to measure various chemical mediators in the blood and~     cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients~     treated with a COX-2 inhibitor.~   "
261846|NCT00122083|"~     The purpose of this study is to determine the effectiveness of a simple marketing~     intervention in changing attitudes towards depression and its treatment among university~     students.~   "
261847|NCT00122070|"~     Objective:~      The objective of this study is to quantitatively examine the efficacy of Seroquel (active~     ingredient quetiapine fumarate) in subjects with Borderline Personality Disorder (BPD). A~     secondary objective is to characterize the safety and tolerability of utilizing quetiapine in~     patients with Borderline Personality Disorder.~      Design:~      Investigator initiated, 6-week, non-placebo controlled, non-randomized, open-label, single~     drug, single-center, medication trial.~      Participants:~      Volunteers (n = 15) diagnosed with Borderline Personality Disorder using the Structured~     Clinical Interview for DSM-IV Personality Disorders (SCID-II).~      Interventions:~      Subjects with Borderline Personality Disorder are washed out of all other medications. The~     subjects are then given the study drug at a dose within the drug's known therapeutic range.~   "
261848|NCT00122057|"~     The aim of this study is to determine whether antibiotic treatment could reduce mechanical~     ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical~     ventilation.~   "
261849|NCT00122044|"~     This study is an open-label trial of trihexyphenidyl in children with upper extremity~     dystonia due to cerebral palsy. It is hypothesized that trihexyphenidyl in doses up to~     0.75mg/kg/day would be well-tolerated and show significant changes on the Melbourne scale of~     upper extremity function.~   "
261850|NCT00122031|"~     This study will investigate the use of deep brain stimulation (DBS) to reduce symptom~     severity and enhance the quality of life for patients with treatment-refractory major~     depression.~   "
261851|NCT00122018|"~     Patients with abnormal kidney function are at increased risk for complications following~     heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged~     stay in the critical care unit and hospital, and the increased risk of death. Prior attempts~     at kidney protection for heart surgery patients have had mixed results. Two medicines,~     fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other~     circumstances that cause kidney stress. The purpose of this study is to determine whether~     these medications will help to maintain the function of diseased kidneys during heart~     surgery.~   "
261852|NCT00122005|"~     Androgen (a male sex hormone) deprivation is the standard therapy for metastatic prostate~     cancer and results in regression or control of disease in 80-85% of patients. This hormone~     therapy results in a progression-free survival of 12-18 months and overall survival of 24-30~     months. However, all patients ultimately develop hormone-refractory prostate cancer (HRPC).~     Management of HRPC patients is a significant challenge for both patient and physician.~     Neither past nor current chemotherapy regimens have shown curative potential in patients with~     HRPC. Thus new treatment strategies are a high priority.~      A major focus of new treatment strategies is to enlist the aid of the immune system,~     particularly the development of prostate cancer vaccines. There has been a number of studies~     using dendritic cell based vaccines and the treatment has been well tolerated. Specific~     T-cell immune responses have been observed and occasional evidence for tumor regression. A~     reduction in serum prostate-specific antigen (PSA) has been observed as well. Lengthening the~     time-to-progression and delays in the onset of bone pain have been observed in subsets of~     patients with HRPC.~      The initial preclinical observations suggesting that a granulocyte-macrophage~     colony-stimulating factor (GM-CSF) gene transduced allogeneic (GVAX) prostate cancer vaccine~     may be efficacious in poorly immunogenic cancers were reported.~      The objective of this study is to evaluate the safety and immunologic effects of vaccinations~     with Allogeneic Prostate GVAX® (CG1940 & CG8711) in patients made lymphopenic by treatment~     with chemotherapy and infused with autologous peripheral blood mononuclear cells (PBMC).~     Clinical observations and laboratory measurements will be monitored to evaluate safety,~     toxicity and immune responses. Additionally, the effects of treatment on serum PSA levels and~     tumor response will be evaluated.~   "
261853|NCT00121992|"~     This is a prospective, non-blinded randomized phase III trial. Patients will be~     post-surgically stratified at inclusion first according to the participating institution,~     then according to menopausal status and will be randomly assigned to receive either:~        -  TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks~          (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500~          mg/m2 as an i.v. bolus on day 1 every 3 weeks.~        -  FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination~          with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v.~          bolus on day 1 every 3 weeks.~   "
261893|NCT00121459|"~     The purpose of this trial is to determine whether using the diaphragm and a lubricant get can~     reduce women's risk of acquiring an HIV infection.~   "
261854|NCT00121979|"~     Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United~     States Food and Drug Administration (FDA), but it can be used in research studies like this~     one. RCV (Racivir®) is part of a class of drugs known as Nucleoside Reverse Transcriptase~     Inhibitors (NRTIs), which are intended to block a further increase in the amount of HIV~     virus in the body. Laboratory research suggests that RCV (Racivir®) may be effective in~     patients who have developed resistance to other NRTIs, particularly 3TC (lamivudine,~     Epivir®). However, a study of RCV (Racivir®) has not been done with patients who have~     previously been treated with other HAART (Highly Active Antiretroviral Therapy -- taking~     multiple HIV drugs at once) medications including 3TC (lamivudine, Epivir®).~      The purpose of this study is to evaluate the safety and effectiveness of RCV (Racivir®) when~     used together with other HIV drugs in people who have previously been treated with 3TC~     (lamivudine, Epivir®) and are failing with their current HAART treatments. This study will~     include a total of 60 HIV infected, HAART-experienced subjects currently receiving 3TC~     (lamivudine, Epivir®) as part of their HAART therapy. The study will take place at~     approximately 11 study sites in the US and Latin America.~   "
261855|NCT00121966|"~     The primary objective of this study is:~        -  To investigate whether insulin aspart with meals is better than a standard treatment~          with insulin NPH at bedtime, evaluated by HbA1c.~      The secondary objectives of this study are:~        -  To study if a combination treatment with metformin and/or rosiglitazone and insulin~          aspart with meals is better than a standard treatment with insulin NPH combined with one~          or more of the above oral antidiabetic drugs. According to the hypothesis, special focus~          will be given to the treatment group with insulin aspart combined with metformin and~          rosiglitazone. The treatment effect will be evaluated by HbA1c.~        -  To examine the effects of the treatments on glucose metabolism and beta cell function,~          evaluated by diurnal blood glucose, fasting plasma glucose, insulin, C-peptide, and~          lactate.~        -  To examine the effects of the treatments on cardiovascular risk factors evaluated by~          serum lipid profiles, serum free fatty acids, urine albumin/creatinine ratio, and~          electrocardiogram (ECG).~        -  To quantify and describe the patients' subjective experiences of the two different~          insulin treatments (quality of life assessment)~        -  To examine patients with type 2 diabetes for the presence of variability in a series of~          genes, which are known to or are assumed to:~             -  affect the long term outcome;~             -  determine the responsiveness to treatment with diet, exercise and drugs targeting~               the known risk markers for late diabetic complications; and~             -  after intervention, to analyse the complex interrelationships between genotypes and~               clinical endpoints and the responsiveness to actual treatment modalities.~   "
261856|NCT00121953|"~     The purpose of this study is to compare the effect of rosiglitazone versus placebo on soluble~     proinflammatory markers in peritoneal fluid of women with endometriosis.~   "
261857|NCT00121940|"~     The purpose of the study is to evaluate the effect of a Guided Care nurse on the quality of~     the health and well-being of the frail elderly. A specially trained registered nurse will~     work closely with 1-3 primary care physicians to provide the most complex older patients (and~     their unpaid caregivers) with health care that is comprehensive, coordinated,~     patient-centered, and proactive. The study will evaluate the effects of Guided Care on:~        -  older persons' physical and mental health, health services utilization, quality of care,~          self-efficacy, and satisfaction with care;~        -  older persons' unpaid caregivers' burden; and~        -  primary care physicians' satisfaction with their care of chronically ill patients.~   "
261858|NCT00121927|"~     This is a prospective study to determine whether the Atkins diet reduces seizures, creates~     ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be~     enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the~     seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms~     of seizure reduction, ketosis, and side effects for a 6-month period.~   "
261859|NCT00121914|"~     Hepatocellular carcinoma (HCC) is a consequence of liver cirrhosis. In early tumour stages,~     tumour resection or liver transplantation are therapeutic options; later tumour stages may be~     treated with locally ablative treatments such as percutaneous ethanol instillation (PEI),~     transarterial chemoembolization (TACE) or radio-frequency thermoablation. This randomized~     study investigates the effect of PEI on survival of patients with HCC. All patients will~     receive hormonal treatment (long-acting somatostatin intramuscularly [i.m.]) and will be~     randomized for treatment with PEI or no additional treatment.~   "
261860|NCT00121901|"~     Post-ERCP pancreatitis can be a serious complication to ERCP. Two studies have shown a~     promising preventive effect of glyceryl nitrate. This study should provide a final answer to~     the clinical question: Does glyceryl nitrate prevent post-ERCP pancreatitis? The study is a~     prospective, randomized, double blind, placebo-controlled multicenter trial. The~     investigators intend to include 1600 patients from Norway, Sweden, Denmark, and France.~      The patients will receive either placebo or a glyceryl nitrate patch (15 mg/24 hours).~     Follow-up will occur after 7 days. The primary outcome measure will be post-ERCP~     pancreatitis, and secondary outcome measures will be mild, moderate and severe pancreatitis;~     post procedure pancreatitis-related mortality; and adverse events.~   "
261861|NCT00121888|"~     The purpose of the study is to evaluate the effectiveness and tolerability of~     controlled-release paroxetine (Paxil-CR) compared to placebo (an inactive substance) for~     individuals who continue to have symptoms of post traumatic stress disorder (PTSD) despite~     receiving prolonged exposure therapy.~   "
261862|NCT00121875|"~     Growth hormone treatment improves body fat distribution but also causes insulin resistance.~     Scientists have recently linked insulin resistance with special stores of fat in the muscles,~     which can be measured by magnetic resonance imaging (MRI). The researchers hypothesize that~     growth hormone will paradoxically reverse the linkage between muscle fat stores and insulin~     resistance. To assess this association and to investigate the cause(s), the researchers will~     measure muscle fat stores during growth hormone treatment. Other parameters linked to insulin~     resistance (glucose tolerance, blood markers, and body composition) will also be assessed.~     This study may lead to improved strategies for monitoring growth hormone therapy.~   "
261863|NCT00121862|"~     This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in~     adult subjects who have no evidence of previous exposure to the Leishmania parasite.~   "
261865|NCT00121836|"~     This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus~     intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients~     received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg~     intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was~     until disease progression or unacceptable toxicity. The target sample size was <100~     individuals.~   "
261866|NCT00121823|"~     The ability to test candidate pre-erythrocytic stage malaria vaccines, using a~     well-established sporozoite challenge model, in a field setting with group sizes of tens~     rather than hundreds of volunteers would greatly facilitate identification of the most~     promising vaccine candidates. The investigators assessed the suitability and acceptability of~     this method in a field trial in semi-immune volunteers exposed to natural infection during~     the high malaria transmission season.~   "
261867|NCT00121810|"~     This 2-arm study recruited kidney transplant patients who were receiving standard care of~     calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily)~     and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was~     discontinued and replaced by sirolimus therapy (in combination with CellCept and~     corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was~     evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size~     was 100-500 individuals.~   "
261868|NCT00121797|"~     In the last years urinary tract infections (UTI) and pyelonephritis have been the most common~     reason for readmission to our hospital after birth. UTI is know to be one of the leading~     causes of postpartum fever affecting about 3%-8% of all postpartum women.~      The investigators hypothesize that collecting urine cultures pre- and postnatally may help~     identify women at risk for developing UTI, while treating women with positive cultures could~     decrease the rehospitalization rate due to postpartum fever. Collecting data during delivery~     may help identify women at risk for this complication.~   "
261869|NCT00121784|"~     Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will~     enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be~     randomized to either continue this regimen or CNI therapy will be discontinued and replaced~     by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2~     regimens on efficacy, safety and renal function will be evaluated.The anticipated time on~     study treatment is 1-2 years and the target sample size is 500+ individuals.~   "
261870|NCT00121771|"~     Animal and human studies have shown that the prime-boost immunization strategy using malaria~     antigens expressed in plasmid or viral vectors induces strong cellular immune responses. An~     immunization regimen with the malaria vaccines DNA ME-TRAP followed by MVA ME-TRAP induced~     strong T cell responses in adults in the United Kingdom (UK) and in the Gambia but did not~     provide significant clinical protection against infection. The investigators assessed two new~     vaccines which utilize a similar immunization strategy but a different malaria antigen, a~     circumsporozoite (CS) protein. The entire CS protein was expressed either in a modified~     vaccinia virus Ankara (MVA) CS, or an attenuated fowlpox virus strain (FP9) CS.~   "
261871|NCT00121758|"~     This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5,~     in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to~     more than 50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first~     phase I trial in non-HIV infected volunteers. Lower doses of each peptide could have a~     similar immunogenicity.~   "
261872|NCT00121745|"~     This is a dose-seeking study that will test the safety of increasing doses of Rexin-G, given~     intravenously, in patients with advanced or metastatic pancreatic cancer who have failed~     standard chemotherapy. Rexin-G is a tumor-targeted gene therapy vector that contains a~     killer gene that blocks the action of the human cyclin G1 gene. Cyclin G1 is a cell cycle~     control element that plays an important role in cancer growth. When injected into a vein, the~     Rexin-GTM vector seeks out and accumulates in cancerous tumors, therefore, increasing the~     concentration of the drug in the cancerous tumors and not in normal neighbouring organs.~   "
261873|NCT00121732|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974~     administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or~     on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed~     following effective therapy or for which no effective therapy exists.~   "
261874|NCT00121719|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in~     patients with solid tumors or lymphomas.~   "
261875|NCT00121706|"~     The primary aim of the proposed pilot study is to assess the effects of fast food meals,~     varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.~   "
261876|NCT00121693|"~     The purpose of this study is to determine whether listening to music will demonstrate changes~     in human postural stability and whether those changes might be useful in fall prevention~     strategies.~   "
261877|NCT00121680|"~     The purpose of this study is to study the safety of E7080 administered to patients with solid~     tumors or lymphomas.~      Please note: this study is now recruiting patients with advanced and/or metastatic melanoma~     only.~      In the current phase of this study, To determine the MTD and the pharmacokinetic profile of~     E7080 when given as continuous daily (qd) dosing in combination with temozolomide.~   "
261878|NCT00121667|"~     The purpose of this clinical research study is to learn whether Saxagliptin added to~     Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic~     subjects who are not sufficiently controlled with Metformin alone~   "
261879|NCT00121654|"~     The study aims at assessing safety and efficacy of Spinal Cord Stimulation (SCS) for the~     treatment of refractory angina pectoris in a single blind, prospective, multicenter study.~      Sixty patients with refractory angina with new SCS device implantation will be randomized to~     one of three treatment groups:~        -  paresthesic SCS;~        -  subliminal SCS;~        -  low (non effective) stimulation (control).~      Clinical follow-up will be done at 1 and 3 months. Control group patients will then be~     randomized to paresthesic SCS or subliminal SCS for another 3 months and the 2 groups will be~     reassessed at 6 months.~   "
261880|NCT00121641|"~     The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is~     more effective than placebo as a treatment for type 2 diabetic subjects who are not~     sufficiently controlled with diet and exercise~   "
261881|NCT00121628|"~     The purpose of the study is to determine if AMG 706 will have clinically meaningful~     anti-tumor activity in subjects with locally advanced or metastatic thyroid cancer who are~     not candidates for radioactive iodine therapy or local therapies.~   "
261882|NCT00121615|"~     The objective of the study is to describe the safety, tolerability, and efficacy of the~     long-term administration of etanercept in adults with psoriasis who have completed etanercept~     psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension.~     Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004.~     Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.~   "
261883|NCT00121602|"~     The purpose of this study is to evaluate whether the efficacy of darbepoetin alfa SF is~     equivalent to that of darbepoetin alfa RB for the treatment of anemia in patients with~     chronic kidney disease (CKD) receiving hemodialysis.~   "
261884|NCT00121589|"~     This study will explore whether taking the vitamins lutein and zeaxanthin, with or without~     Omega-3 fatty acid (fish oil or docosahexanoic acid, also known as DHA) will change the~     amount of lutein and zeaxanthin in the blood among people with age-related macular~     degeneration (AMD). AMD is one of the leading causes of legal blindness among people over the~     age of 50 in developed countries. In the disease, the retina of the eye, the sensory portion,~     worsens in condition. AMD causes progressive loss of central vision, with only peripheral~     vision remaining, that is, the ability for someone to see from the edges of the eye. To date,~     there is not any effective treatment to improve vision for most people whose AMD is advanced.~     Yet some data from research studies suggest a possible role of antioxidants, including~     lutein, in reducing the risk of AMD and cataracts. Lutein and zeaxanthin belong to the~     carotenoid family of vitamins, of which there are more than 600. There are 40 or 50~     carotenoids in the typical diet of human beings, but only 14 major dietary ones are~     identified in human plasma. Lutein, in particular, is a vitamin that is found naturally in~     the retina, especially in the macula, the region of the eye that is essential for fine,~     detailed vision. Previous studies have shown that higher levels of foods rich in Omega-3~     fatty acid were associated with a lower likelihood of AMD.~      Patients ages 60 and older who may or may not have AMD, who do not have certain other serious~     eye disorders, and who have not had potentially life-threatening illness in the last year may~     be eligible for this study. About 40 people will participate.~      Patients will undergo a medical history and physical examination. A blood collection of about~     4 tablespoons will be done to measure the amount of lutein and other vitamins in the blood.~     Patients will have a complete eye examination consisting of procedures standard to those~     given by ophthalmologists. Participants will have photographs taken of their eyes, and they~     will undergo a visual field test. Flicker photometry also will be conducted. This consists of~     the patients looking at a flashing bluish light with one eye at a time, and turning a knob~     until the light stops flashing. Then during the test, patients will look away from the light~     and turn the knob until the flashing stops.~      During this study study, patients will be asked to not take more than two tablets each day of~     multivitamins that contain lutein. The vitamin supplements will be provided as pills that~     represent one of two vitamin regimens given on a random basis: either lutein and zeaxanthin~     with DHA or lutein and zeaxanthin without DHA added. The amounts would be 10 mg/day of lutein~     and 2 mg/day of zeaxanthin, with or without 1 g/day of DHA. Patients will return to the study~     center for follow-up visits at 1 month, 3 months, 6 months, and 9 months. During those~     visits, some of the examinations done earlier will be repeated so that the researchers can~     evaluate the effects of supplements on patients' eyes. Patients will also be watched for~     possible side effects from the vitamins supplements. Lutein and zeaxanthin supplements are~     considered to be safe with possible minor side effects, such as headaches and difficulty in~     swallowing the tablets. Fish oil or DHA supplements may also cause abdominal discomfort.~      If information obtained from this study may be important for participants' health, they will~     be informed when it is available. There are no plans to give participants the results of any~     medical tests, evaluations, or other research data. Further research may be necessary before~     such results become meaningful.~   "
261885|NCT00121563|"~     This study will evaluate the role of thalidomide, a tumor necrosis factor (TNF)-alpha~     modulator, on severe inflammation and relief of pain following extraction of wisdom teeth.~     TNFs are substances that affect the pathways of pain. This study involves an experimental~     group in which patients will be given thalidomide or a placebo (an inactive substance); a~     negative control group receiving the medication diazepam or a placebo; and a positive control~     group receiving diazepam or ibuprofen.~      Patients who are males ages 16 to 35, who are not allergic to aspirin or other nonsteroidal~     anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics, and who in good~     health may be eligible for this study. Females are not eligible, owing to the risks that~     thalidomide presents to unborn children. To minimize the risk of fetal malformations, male~     patients who participate must use a condom during sexual intercourse for 4 weeks following~     the study and must not donate blood for 4 weeks.~      The medications used in the study will be given 1 hour before surgery. Then after the wisdom~     teeth are removed, a small piece of tubing will be placed into both sides of the patient's~     mouth where the teeth were removed. Every 20 minutes, for the next 6 hours, the researchers~     will collect inflammatory fluid from the tubing, to measure for changes in anti-inflammatory~     action. If they request pain relievers, patients will receive the medication ketorolac~     (Toradol), used for short-term treatment of moderately severe acute pain. Side effects of~     thalidomide include fatigue, dizziness, and rash. The use of ibuprofen and ketorolac may~     include the risk of gastrointestinal ulcers and bleeding. Diazepam can cause involuntary~     muscle movements and drowsiness, as well as dizziness lasting for up to 24 hours after it has~     been used as sedation. Patients will be instructed not to try to walk alone or to try to~     drive a vehicle during that period. Other risks related to participation in this study~     include those usually experienced with removal of wisdom teeth-that is, pain and swelling,~     bruising from insertion of the sedative into a vein (if needed), possible infection at the~     extraction site, prolonged bleeding, and numbness.~      Benefits from participating are having wisdom teeth removed at no cost as well as close~     monitoring before and after surgery. Results from the study may help people in the future by~     improving the management of pain following surgery.~   "
261886|NCT00121550|"~     A growing body of evidence links Chlamydia pneumoniae to the progression of coronary heart~     disease. The purpose of this study is to determine the positive and negative effect of 14~     days treatment with clarithromycin 500 mg daily in patients already suffering from stable~     coronary heart disease. The participants will be followed for at least two years after the~     treatment.~      Abbott Laboratories supplied Clarithromycin and placebo tablets.~   "
261887|NCT00121537|"~     The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC)~     versus standard wet to dry dressing in treating lower leg fasciotomies.~   "
261888|NCT00121524|"~     Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation~     since the start. It improves outcome in animal studies, but has never been investigated in a~     controlled study in humans. Epidemiologic data indicate that it is an independent negative~     predictor for survival. If this is true in a controlled randomized study, it could be due to~     effects of the drug itself or more likely due to reduced quality of chest compressions and~     ventilations due to the time spent on placing an I.V. needle and injecting drugs.~   "
261889|NCT00121511|"~     The researchers propose that skin improvements may be seen following a course of Efudex,~     (5-fluorouracil), a FDA-approved topical therapy (applied directly to the skin). These~     improvements could be the result of both a reduction of actinic keratoses (small red horny~     growths or flesh-colored wartlike growths caused by overexposure to ultraviolet radiation or~     the sun) and improvement of sun-damaged skin.~      In addition, this research study is being done to determine if the expression of p53, a tumor~     suppressor gene (its activity stops the formation of tumors), is decreased following Efudex~     treatment. Mutations (abnormal changes) in the gene, called p53, are associated with a~     certain type of skin cancer. In addition, p53-mutated genes are known to exist in~     non-cancerous sun-damaged skin. Thus, the presence of p53 mutations may serve as a marker for~     both sun damage and an elevated risk of developing skin cancer.~   "
261890|NCT00121498|"~     Preemptive analgesia is defined as “analgesic intervention provided before surgery to prevent~     or reduce subsequent pain”. By preventing central sensitization using nociceptive blockers by~     regional analgesia we may able to produce a painless postsurgical state. The use of~     preemptive analgesia was reported in various surgical procedures, such as in limb surgeries,~     laparoscopic procedures, mastectomy and vaginal hysterectomy. Regarding abdominal~     hysterectomy there are only few reports, however both, malignancies and benign cases were~     included and conflicting results were obtained regarding the value of preemptive analgesia.~     Since hysterectomy is the most frequent major surgical procedure performed in gynecology, and~     it is estimated that by age 64 years, 40 % of women will have had a hysterectomy, it would be~     of great value to optimize pain treatment in these patients.~      The aim of the present study was to evaluate the effectiveness of preemptive analgesia in~     women who undergo a transabdominal hysterectomy for benign uterine abnormalities.~      Hypothesis: Lidocaine (5%) injection to the scar area before incision is effective in pain~     reduction among women who undergo a transabdominal hysterectomy for benign uterine~     abnormalities .~   "
261891|NCT00121485|"~     The purpose of this study is to determine the safety and effectiveness of the Thoratec~     HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart~     failure patients who do not qualify for cardiac transplantation.~      The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA~     P060040/S005).~   "
261892|NCT00121472|"~     The purpose of this study is to determine the safety and effectiveness of the Thoratec~     HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in~     end-stage heart failure patients who are listed for cardiac transplant but are at imminent~     risk of dying.~      The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac~     transplantation (reference PMA P060040). It was approved for commercial distribution in~     Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the~     clinical trial will continue to be followed until all have reached a clinical outcome.~   "
261894|NCT00121446|"~     In the setting of acute myocardial infarction (heart attacks), the principle objective of the~     WEST Study is to compare the impact on clinical outcomes of 3 different treatment strategies.~     The first is using medical (drug) therapy alone with standard care. The second strategy is~     identical medical (drug) therapy as the first group combined with early heart catheterization~     (within 24 hours) for angiography and if required, intervention. The third treatment strategy~     is direct admission (within 3 hrs) to the heart catheterization lab for angioplasty.~      WEST patients will be enrolled at first medical contact (using emergency medical services,~     e.g. ambulance) if possible or through Emergency Departments in participating health care~     facilities.~   "
261895|NCT00121433|"~     The purpose of this trial was to determine if injections of leptin would improve vascular~     function in normal-weight, healthy volunteers.~   "
261896|NCT00121420|"~     The primary purpose of the study is to evaluate if motexafin gadolinium with whole brain~     radiation therapy followed by a stereotactic radiosurgery boost is a safe and effective~     treatment.~   "
261897|NCT00121407|"~     The purpose of this study is to demonstrate that Visudyne therapy in patients who have occult~     with no classic subfoveal choroidal neovascularization (CNV) lesions will, with an acceptable~     safety profile, significantly reduce the risk of vision loss compared with placebo (sham~     treatment).~   "
261898|NCT00121394|"~     Infection is a major health problem during birth in Pakistan. This study will look at the~     possibility of using a septic wash to help improve health during birth in Karachi, Pakistan.~   "
261899|NCT00121381|"~     Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin~     elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the~     T-cell activation. These cells are involved in the inflammatory component of the disease.~     This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid~     treatment (commonly used in eczema) in patients with severe atopic dermatitis.~   "
261900|NCT00121368|"~     Smoking can contribute to many health problems for mothers and their babies. In developing~     countries, there is little information about the number of pregnant women that smoke and the~     reasons why some pregnant women choose to smoke. The purpose of this multi-site tobacco use~     survey is to obtain information on knowledge, attitudes and behaviors among pregnant women in~     diverse populations regarding tobacco products.~   "
261901|NCT00121355|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     examine whether nurses prefer to use the NovoFine® Autocover Needle or the BD Safety Glide~     (TM) Syringe (only) in a hospital setting. The number of needle stick injuries will also be~     evaluated and whether these hospital nurses prefer the safety features of the NovoFine®~     Autocover Needle versus those of the BD Safety Glide (TM) Syringe. The identified hospital~     nurses will evaluate the two types of needles during standard administration of insulin to~     patients being treated for diabetes.~   "
261902|NCT00121329|"~     Recent studies have investigated the use of local anesthetics (i.e. lidocaine, mepivacaine)~     to lessen the pain experienced with minor gynecologic procedures such as endometrial biopsy~     and office hysteroscopy. Local anesthetic injected into the uterine cavity has been~     demonstrated effective in some studies at decreasing patient pain associated with these~     intrauterine procedures at an anesthetic concentration of at least 2%. Based on this~     evidence, we hypothesized that an intrauterine lidocaine infusion may reduce patient pain~     during first trimester abortions.~   "
261903|NCT00121316|"~     This study is not being conducted in the United States.~      Patients who are intolerant of topical corticosteroids (TCS) have either experienced an~     adverse event resulting from the use of TCS, or require unacceptable levels of exposure to~     TCS in order to control their AD. This is of particular concern for patients with recurrent~     flares on delicate skin areas such as the head and neck.~      The purpose of this study is to investigate whether pimecrolimus cream 1%, a non-steroidal~     anti-inflammatory drug, is efficacious in treating mild to moderate head and neck AD in~     patients who are intolerant of, or dependent on topical corticosteroids.~   "
261904|NCT00121303|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. It is not yet known~     whether cytarabine and daunorubicin followed by gemtuzumab ozogamicin is more effective than~     cytarabine and daunorubicin in treating acute myeloid leukemia or myelodysplastic syndromes.~      PURPOSE: This randomized phase III trial is studying cytarabine and two different doses of~     daunorubicin to see how well they work compared to cytarabine and daunorubicin followed by~     gemtuzumab ozogamicin in treating older patients with acute myeloid leukemia or~     myelodysplastic syndromes.~   "
261905|NCT00121290|"~     This phase I trial studies the side effects and best dose of SJG-136 in treating patients~     with solid tumors that are metastatic or cannot be removed by surgery. Drugs used in~     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~   "
261906|NCT00121277|"~     RATIONALE: Drugs used in chemotherapy, such as vorinostat and capecitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and~     capecitabine in treating patients with unresectable or metastatic solid tumors.~   "
261907|NCT00121264|"~     This phase I trial is studying the side effects and best dose of 17-AAG when given together~     with sorafenib in treating patients with unresectable or metastatic solid tumors. Drugs used~     in chemotherapy, such as 17-AAG, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the tumor. Giving 17-AAG together with sorafenib may kill more tumor cells.~   "
261924|NCT00121030|"~     The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia~     Treatment (PSQ-AT) in gynecological cancer patients treated with darbepoetin alfa or~     recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.~   "
261908|NCT00121251|"~     This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine,~     and capecitabine and to see how well they work in treating patients with unresectable and/or~     metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     sorafenib together with gemcitabine and capecitabine may kill more tumor cells.~   "
261909|NCT00121238|"~     This phase II trial is studying how well cilengitide works in treating patients with prostate~     cancer. Cilengitide may stop the growth of prostate cancer by blocking blood flow to the~     tumor~   "
261910|NCT00121225|"~     This phase II trial is studying how well vorinostat works in treating patients with~     metastatic or unresectable melanoma. Vorinostat may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
261911|NCT00121212|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography using carbon-11~     acetate, may help find metastases from prostate cancer and may help predict whether prostate~     cancer will come back after treatment.~      PURPOSE: This clinical trial is studying how well positron emission tomography using~     carbon-11 acetate works in finding metastases and predicting recurrence in patients with~     prostate cancer who are at risk for recurrence after treatment.~   "
261912|NCT00121199|"~     This phase II trial is studying how well giving combination chemotherapy together with~     rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage~     IV diffuse large B-cell lymphoma. Drugs used in chemotherapy work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal~     antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help~     kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of~     cancer cells by blocking blood flow to the cancer. Giving combination chemotherapy together~     with monoclonal antibodies may kill more cancer cells.~   "
261913|NCT00121186|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a~     donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer~     cells. It also stops the patient's immune system from rejecting the donor's stem cells. The~     donated stem cells may replace the patient's immune system and help destroy any remaining~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving tacrolimus and~     methotrexate after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan~     followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor~     stem cell transplant for relapsed lymphoma.~   "
261914|NCT00121173|"~     RATIONALE: Vaccines made from protein and DNA may help the body build an effective immune~     response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent~     cervical cancer.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy~     and to see how well it works in preventing cervical cancer in patients with cervical~     intraepithelial neoplasia and human papillomavirus.~   "
261915|NCT00121160|"~     The proposed investigation will conduct a randomized, clinical trial to test the efficacy of~     a cognitive behavioral stress management (CBSM) group intervention on immune response to~     vaccine and distress among women at elevated risk for breast cancer.~      Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and~     secondary antibody response to vaccines compared to women in the comparison group.~      Hypothesis 2: Women who participate in a 10-week CBSM group intervention will report lower~     levels of distress immediately after and 6 months after the intervention compared to women in~     the comparison group.~   "
261916|NCT00121147|"~     The purpose of this study is to compare the additive effect on eye pressure of Azopt and~     Alphagan P to Travatan.~   "
261917|NCT00121134|"~     The purpose of this research study is to study the effects (good and bad) of bevacizumab~     alone, bevacizumab with low-dose continuous chemotherapy (called metronomic chemotherapy), or~     bevacizumab with capecitabine, on you and your cancer. The goals of the study will be to:~        -  Examine the safety of these drugs~        -  See how easy or difficult it is to be treated with them~        -  Monitor for any signs of recurrent cancer~        -  Look at blood markers that might indicate how the treatment is working~   "
261918|NCT00121121|"~     Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to~     induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to~     evaluate the safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4~     peptides from Gag, Pol, RT and Nef HIV-1 proteins, each peptide linked to TT) intradermally~     (ID) compared to IM administration.~   "
261919|NCT00121108|"~     This study (MI-CP117) is a Phase 3, randomized, double-blind, placebo-controlled trial~     designed to determine if MEDI-524 compared to placebo will result in clinical efficacy in the~     reduction of RSV hospitalization in otherwise healthy Native American Indian Infants in the~     Southwestern United States during their first RSV season.~   "
261920|NCT00121095|"~     The purpose of this study is to investigate the safety, tolerability and anti-tumor effects~     of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with~     castrate metastatic prostate cancer.~   "
261921|NCT00121069|"~     This pilot study is designed to assess the efficacy of escitalopram in the treatment of~     specific phobia in adult outpatients.~   "
261922|NCT00121056|"~     The purpose of this study is to determine if Enbrel® or Kineret® will have a positive effect~     on subject functionality as measured by the Health Assessment Questionnaire Disability Index~     (HAQDI).~   "
261923|NCT00121043|"~     The primary purpose of this study is to assess the ease-of-use of SimpleJectTM compared to~     pre-filled syringe(s) when using Kineret® in RA subjects. The secondary purpose of this study~     is to assess the level of fear and anxiety associated with the use of both injection methods,~     to assess safety when using SimpleJectTM and to evaluate the Ease-of-Administration~     Questionnaire (EAQ) in terms of the quality of items, item performance, and the instrument~     reliability.~   "
261925|NCT00121017|"~     The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based~     therapy will continue to keep the viral load at very low levels after initial treatment with~     a combination of Kaletra (lopinavir/ritonavir) plus tenofovir and emtricitabine.~   "
261926|NCT00121004|"~     In this study, hospitalized patients will first be surveyed regarding their interest in a~     traditional advanced directive (AD) and then in a modified AD.~   "
261927|NCT00120991|"~     There is evidence linking cardiopulmonary bypass to negative side effects when used for~     coronary artery bypass grafting. Coronary artery bypass grafting can be performed without the~     use of cardiopulmonary bypass. The purpose of this study is to determine the positive and~     negative effects of coronary artery bypass grafting with or without the use of~     cardiopulmonary bypass. The patients will be followed at least one year after surgery.~   "
261928|NCT00120978|"~     Large population-based studies suggest that patients with chronic obstructive pulmonary~     disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a~     large proportion of the total number of deaths. How COPD increases the risk of poor~     cardiovascular outcomes is largely unknown. However, there is growing evidence that~     persistent low-grade systemic inflammation is present in COPD and that this may contribute to~     the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients.~     Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages~     of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of~     vulnerable vessels. Recently, our group has demonstrated in a relatively small study that~     short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD~     patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels.~     Although very promising, these data cannot be considered definitive because the study was~     small in size and scope (N=41 patients). Additionally, this study did not address the~     potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is~     an important short-coming because combination therapy of ICS and LABA have been shown to~     produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in~     the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®)~     reduces systemic inflammation and that combination therapy (Advair®) is more effective than~     steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement~     a randomized controlled trial to determine whether ICS by themselves or in combination with~     LABAs can:~        1. reduce CRP levels in stable COPD patients and~        2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular~          morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant~          protein-1 (MCP-1)~   "
261929|NCT00120965|"~     The AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial compares the~     efficacy of circulatory assist by manual chest compression versus an automated chest~     compression device (AutoPulse™) during the resuscitative attempt following out-of-hospital~     cardiac arrest.~   "
261930|NCT00120952|"~     In this randomised study, the migration of a specific cemented titanium femoral stem will be~     compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric~     analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated~     to point out any interference from the modulus of the stem investigated.~   "
261931|NCT00120939|"~     The primary purpose of this study is to evaluate the safety, side effects, and dosage for~     Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced~     cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and~     drug interactions will be evaluated.~   "
261932|NCT00120926|"~     Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate~     that prematurely born neonates commonly develop a severe nutritional deficit during the first~     weeks after birth, referred to as extrauterine growth restriction. Despite an increase in~     growth during the second month of hospitalization, many neonates are ultimately discharged~     home having grown inadequately. The early nutritional deficit affects weight gain as well as~     growth in length and head circumference.~      Growth measurements such as weight, length, and head circumference, however, are macroscopic~     measures of nutritional status and underestimate the physiologic consequences of prolonged~     nutritional deprivation. Energy and micronutrient deficiencies alter growth at a cellular and~     tissue level before macroscopic measures are altered. In the brain, for instance, energy is~     required for cell division and neuronal growth, glial cell function, and myelination. Energy~     deprivation may consequently alter neuronal function and growth, resulting in adverse~     neurodevelopmental outcomes.~      Immunocompetence also appears to be sensitive to the untoward effects of energy and~     nutritional deficiency. Malnourished neonates often exhibit immune deficiencies related to~     inadequate protein intake that compound an already immature immune system. Such~     immunodeficiency results in susceptibility to infectious agents that creates substantial~     morbidity and mortality to the course of intensive care for premature infants.~      A recent study suggests that postnatal malnutrition and growth restriction are inevitable if~     current recommended dietary intakes are followed. Multicenter studies show that variation in~     dietary intake accounts for 45% of the variation in growth. Hence, efforts have focused on~     determining whether nutritional deficiency and the observed growth restriction of premature~     infants can be prevented through the use of more optimal nutritional intake. In addition,~     inadequate protein support may be a primary cause for growth failure.~      Based on animal studies showing high in utero amino acid flux observed during the latter~     phase of gestation, Thureen et al have suggested the use of higher doses of amino acid~     supplementation in order to minimize growth restriction and improve outcomes of premature~     infants. However there are no large human trials that demonstrate that this approach promotes~     better growth or that it is safe. While small doses of amino acids may be inadequate to~     promote normal growth, high doses may lead to elevated serum amino acid levels and increase~     the occurrence of toxicity. Through the implementation of a multicenter, randomized trial and~     tandem mass spectrometry, the investigators propose to evaluate the effects of two distinct~     strategies of amino acid supplementation on serum amino acid profiles and growth of premature~     infants during the first 28 days of life.~   "
261933|NCT00120913|"~     While there may be a decrease in the total number of bleeding days women experience with~     continuous-dosed COCs (no menstrual withdrawal week), these regimens frequently result in an~     increased number of “breakthrough” or non-scheduled bleeding days. Breakthrough bleeding is~     among the main reasons cited for discontinuation of combined COCs dosed traditionally (3~     weeks of active pill, 1 week of placebo) or continuously, and may offset the perceived~     benefit of fewer withdrawal bleeding events for many women taking continuous-dosed COCs. The~     exact mechanisms responsible for breakthrough bleeding patterns during hormonal contraception~     are unknown and may be related to the pill formulation. This study is to determine whether~     progestin type or estrogen dose influences bleeding patterns, side effects, or satisfaction~     with combined oral contraceptives (COC) dosed continuously.~   "
261934|NCT00120900|"~     This study was designed to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in~     treating the signs and symptoms of osteoarthritis of the knee.~   "
261960|NCT00120562|"~     Weight loss achieved by dieting induces multiple changes. These changes include a decrease in~     metabolic rate (the rate in which the body burns its calories), an increase in appetite and~     other physiological and hormonal changes that may be the cause of failure in dieting. Many of~     these parameters that have never been evaluated when weight is lost after gastric bypass~     surgery will be tested in this study.~   "
261961|NCT00120549|"~     The purpose of this study was to determine if assisted embryo hatching can improve pregnancy~     rates for good prognosis patients undergoing in vitro fertilization (IVF) with day 3 embryo~     transfer.~   "
262019|NCT00119756|"~     The purpose of this study is to evaluate the safety and tolerability of intramuscular~     injections (to the buttocks or to the shoulders) of paliperidone palmitate in patients with~     schizophrenia.~   "
261935|NCT00120887|"~     Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in~     systemic lupus erythematosus (SLE) in developed countries. Coronary artery disease and stroke~     contribute to long-term morbidity in surviving patients. Atherosclerosis in SLE is~     multifactorial, with immune/inflammatory endothelial damage, traditional cardiovascular risk~     factors, and prothrombotic factors all playing important roles. Multiple groups have shown~     that hyperlipidemia is predictive of later atherosclerosis in SLE. In the general population,~     statins have become the drug of choice in preventing atherosclerotic events, through two~     mechanisms: lipid lowering that helps to prevent progression, and stabilization of plaques to~     prevent rupture. In the Lupus Atherosclerosis Prevention Trial we will determine if~     atorvastatin reduces the progression of atherosclerosis on helical computed tomography (CT)~     and carotid duplex. Recent work has confirmed that statins have an immunomodulatory role.~     This study will also determine whether statins improve clinical lupus activity or lupus~     serologies (anti-dsDNA and complement).~   "
261936|NCT00120874|"~     The purpose of this study is to determine whether a comprehensive, individualized management~     approach with caregiver training and medication with memantine will alleviate symptoms in~     community dwelling patients with moderate to severe Alzheimer's disease.~   "
261937|NCT00120861|"~     This study is being conducted to compare the safety, effectiveness and tolerance of~     valopicitabine (NM283) when used alone and when valopicitabine is used together with~     pegylated interferon in hepatitis C treatment failure patients. These results will be~     compared against the results of treatment with pegylated interferon plus ribavirin, the~     current standard therapy for treatment of hepatitis C viral infection.~   "
261938|NCT00120848|"~     Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and~     genitals in men and women. Several types of HPV infection are transmitted by sexual activity~     and, in women, can infect the cervix (part of the uterus or womb). This infection often goes~     away by itself, but if it does not go away (this is called persistent infection), it can lead~     in women over a long period of time to cancer of the cervix. If a woman is not infected by~     HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow~     up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV~     infection. The current study invites all of the 1113 subjects in the HPV-001 study that~     received all three doses of vaccine/placebo to be enrolled and followed-up for several~     additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to~     evaluate the safety of the vaccine. Subjects will remain in the same study group as in the~     primary study. No vaccine or placebo will be administered in this study.~      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep~     2007.~   "
261939|NCT00120835|"~     This study is being conducted in treatment-naive patients (no previous hepatitis C treatment)~     to evaluate the safety of valopicitabine (NM283) alone and together with pegylated~     interferon, a drug approved by the Food and Drug Administration for the treatment of~     hepatitis C infection. This study is also evaluating the ability of valopicitabine to~     decrease the amount of hepatitis C virus in the body. The results for patients taking~     valopicitabine alone will be compared with the results for patients taking valopicitabine~     together with pegylated interferon.~   "
261940|NCT00120822|"~     Supplementation with folic acid and iron is recommended for pregnant women in order to~     prevent them from developing anemia. In malaria endemic areas of Africa, the World Health~     Organization (WHO) now recommends that pregnant women should also be given~     sulfadoxine-pyrimethamine (SP) once a month after quickening to protect them against malaria~     which is especially harmful during pregnancy. However, folic acid is an antagonist of SP so~     there is a possibility that giving folic acid with SP could interfere with the ability of the~     latter to provide protection against malaria. To investigate this possibility Gambian~     primigravidae with malaria parasitemia have been given SP and folic acid at the same time or~     on separate occasions two weeks apart and the ability of SP to cure the malaria infection~     investigated.~   "
261941|NCT00120809|"~     Malaria is particularly harmful during pregnancy causing anemia in the mother and low birth~     weight which, in turn, increases infant mortality. Thus, the World Health Organization (WHO)~     now recommends that all pregnant women who live in malaria endemic areas of Africa should~     receive sulfadoxine-pyrimethamine (SP) at monthly intervals during the second and third~     trimesters of pregnancy. Malaria is especially severe during first pregnancies and the value~     of intermittent preventative treatment with SP during first pregnancies has been clearly~     shown. However, it is less certain whether multigravidae, who are at less risk, also benefit~     from intermittent preventative treatment with SP. To investigate this, a trial has been~     conducted in Gambian multigravidae who were given intermittent preventative treatment with SP~     or placebo during the second and third trimesters. The prevalence of anemia six weeks after~     delivery, low birth weight and poor outcome of pregnancy in women in each group were studied.~   "
261942|NCT00120796|"~     Chronic hepatitis B infection is a major public health issue in Senegal. The study will~     compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine~     (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on~     the control of viral replication in patients with a replicative hepatitis B virus (HBV)~     infection and an increase in hepatic enzymes.~   "
261943|NCT00120783|"~     This study investigated whether a calibrated reduction in antiretroviral drug pressures could~     stabilize the evolution and the pathogenic potential of resistant HIV viruses.~   "
261944|NCT00120770|"~     This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the~     effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of~     HIV infection.~   "
261945|NCT00120757|"~     Osteopenia and osteoporosis are being described more frequently in people with HIV infection.~     This study will test the efficacy of alendronate in comparison with a placebo after 2 years,~     in people with primary osteoporosis. People will receive the recommended adequate intake of~     calcium and vitamin D.~   "
261946|NCT00120744|"~     The objectives of the study were to determine whether ondansetron treatment would reduce:~        -  the amount of vomiting in the emergency department;~        -  the need for intravenous rehydration; and~        -  the need for hospitalization.~   "
261993|NCT00120120|"~     The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the~     efficacy and safety of lenalidomide in the treatment of painful lumbar radiculopathy.~   "
261947|NCT00120731|"~     High amounts of calcium in the urine (hypercalciuria) can cause development of kidney stones~     in children. Treatment for these children includes plenty of fluids, a low-salt diet and~     medications such as potassium citrate. A major advantage of potassium citrate, as compared to~     hydrochlorothiazide, is its lack of side effects. One problem the researchers and others have~     observed is that some children continue to form kidney stones despite correction of~     hypercalciuria with potassium citrate. One possible explanation is that in some individuals~     potassium citrate therapy results in an excessive elevation of urine pH, a situation that may~     predispose to calcium phosphate stone formation. In this study, the researchers will study~     the effects of potassium citrate on urine chemistries and acid-base balance in three groups~     of children aged 5-17 years:~        -  children who are hypercalciuric stone formers;~        -  healthy children without a history of hypercalciuria or kidney stones.~      Particular attention will be paid to try to identify those who develop a very high urine pH~     (>8) and the factors leading to this metabolic reaction.~      The researchers will try to learn whether it is the child’s characteristics, the disease~     manifestations, the dose of the drug, or a combination of the above which may be the cause of~     the development of very alkaline urine. Based on the results, the researchers hope to be able~     to better “tailor” the individual treatment for each child with kidney stones.~   "
261948|NCT00120718|"~     The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects~     vascular function in patients with atherosclerosis and hyperlipidemia.~   "
261949|NCT00120705|"~     The purpose of this study is to assess the ability of darbepoetin alfa to maintain hemoglobin~     concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W).~   "
261950|NCT00120692|"~     The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia~     Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or~     recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.~   "
261951|NCT00120679|"~     The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia~     Treatment (PSQ-AT) in non small cell lung cancer patients treated with darbepoetin alfa or~     recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.~   "
261952|NCT00120666|"~     This study will determine how the brain controls movements by sending messages to the spinal~     cord and muscles. Researchers want to know if strengthening a hand muscle will increase the~     strength of the same muscle in the other hand, and if these changes happen in the brain or~     spine, or both. Plasticity in this study refers to the capacity for continuous changes of the~     neural pathways in the brain and nervous system. Researchers have seen cases in which using a~     muscle extensively (force production) in one muscle group has increased the strength of the~     same muscle group on the opposite side of the body (force transfer). This situation happens~     without the unused muscle becoming larger-suggesting that the practice causes changes in some~     parts of the brain or spine. It is vital for scientists to know how this effect works, so~     that they can create new rehabilitation methods for people who cannot move or who have~     difficulty moving one side of their body.~      Patients ages 18 to 60 who are in good health and who do not have a history of major~     conditions affecting the bones, joints or nervous system may be eligible for this study.~     Patients will undergo a medical examination. There will be 1 or 2 testing sessions, 20~     training sessions, and 1 or 2 final testing sessions, with patients being asked to come to~     the laboratory for as few as 4 times (about 10 hours total) or for up to 25 visits (about 20~     hours total). The investigator will indicate which of six different groups that a patient is~     selected for.~      During testing sessions, the strength of the pointer and little fingers in each hand will be~     determined through the use of very brief electrical pulses. There also will be transcranial~     magnetic stimulation (TMS) and 1 Hz TMS. The researchers will place one or two wire coils on~     the patient's scalp and make marks on the scalp which will be removed at the end of the~     session. During the TMS, a brief electrical current is passed through the coil, creating a~     magnetic pulse that stimulates the brain. Patients will hear a click sound and feel a~     snapping sensation on the skin. They may also feel and see small twitches in the hand~     muscles, and the fingers or wrist may move. There will be a total of about 300 magnetic~     stimuli, at a rate of 10 pulses per minute. Patients will also have an electromyogram (EMG),~     a procedure recording electrical activity in the muscles that are activated by electrical or~     magnetic stimulation. Metal electrodes will be attached to the skin over the muscle. During~     the EMG, patients will be asked to tense certain muscles slightly. Depending on the group a~     patient is assigned to, he or she may be asked to use the right index finger by using~     voluntary muscle movement, electrical stimulation, his or her imagination, electrical~     stimulation of a different hand muscle, or voluntary movements immediately followed by~     repetitive TMS.~      Regardless of group assignment, there will be five blocks of 10 repetitions of finger~     exercise per session, 200 per week, and 1,000 throughout the whole study. During the study~     sessions, patients will be able to talk and move around. They can take a break and leave the~     room if needed. In most cases, the session will take less than 2 hours. There also will be a~     control group whose members will not be training their fingers but who will participate only~     in the testing sessions. TMS is a safe procedure; however, strong contractions of scalp~     muscles have been known to cause headaches. Also, because of the distracting noise of the~     TMS, patients will be fitted with earplugs to wear during the procedure.~      Compensation for research-related discomfort and inconvenience will be made to participants,~     with a maximum of $500 to $600, depending on assignment to groups. This study will not have a~     direct benefit for participants. However, researchers hope to gain information that will help~     them better understand how the two sides of the brain control movement and how they affect~     each other regarding movement control.~   "
261953|NCT00120653|"~     This study will determine whether the medication metoclopramide can improve red blood counts~     in people who have myelodysplastic syndrome (MDS). MDS is thought to affect blood stem cells,~     which can result in low levels of red blood cells-that is, anemia-as well as low white blood~     cell and platelet counts. Patients with MDS are at risk for infection, spontaneous bleeding,~     and possible progression to leukemia, a cancer of bone marrow. Although bone marrow can~     produce some blood cells, this production can be decreased in patients with MDS. The~     definitive way to treat MDS is stem cell transplantation, but serious complications and a~     high risk of death make it unsuitable for patients older than age 60 or those who do not have~     a matched sibling donor. However, scientists have noted improvement in anemia by using~     metoclopramide, an inexpensive, commonly used medication that does not have many negative~     side effects. This study will evaluate the safety and effectiveness of that medicine for~     patients with MDS.~      Patients ages 18 to 72 whose MDS would require low-intensity treatment-for example, with~     growth factor and transfusions-and who are not pregnant or breastfeeding may be eligible for~     this study. There will be about 60 participants.~      Screening tests include a complete physical examination and medical history, during which~     patients will provide a list of current medications or supplements they are taking. There~     will be a collection of about 4 tablespoons of blood for analysis of blood counts as well as~     liver and kidney function. Patients may also undergo a magnetic resonance imaging (MRI) scan~     of their brain, but the procedure is optional. During the MRI, they will lie on a table that~     will slide into the enclosed tunnel of the scanner. The MRI takes about 20 to 30 minutes, and~     patients will be asked to lie as still as possible. There will also be a bone marrow biopsy,~     if patients have not had one done within 4 weeks of the start of this study. Eligible~     patients will take a 10 mg dose of metoclopramide by mouth, three times a day, for 20 weeks.~     They will be given a 4-week supply, which will be renewed monthly at each treatment visit. It~     is essential that patients be seen at NIH during the first, third, and fifth months of the~     study. Visits made in the meantime, at the second and fourth months, may be done at the~     office of their doctors who have referred them for the study, or at NIH. During the treatment~     visits, patients will be asked to update their medical history, health conditions, and use of~     medications or herbal supplements. There will also be a collection of about 1 tablespoon of~     blood for laboratory tests. Patients will be asked to make a similar follow-up visit 1 month~     after they stop taking metoclopramide, so that the response to treatment can be evaluated.~      The use of metoclopramide may cause some people to feel dizzy, lightheaded, tired, or less~     alert than they are normally. For the first 24 to 48 hours, patients should be cautious when~     driving, using machinery, or performing hazardous activities. This medicine will add to the~     effects of alcohol and other central nervous system depressants-such as medicines for~     allergies and colds, tranquilizers, and prescription pain relievers. Patients need to check~     with the research team before taking any of those types of medicines, as well as herbal~     supplements, while using metoclopramide.~      This study may or may not have a direct benefit for participants. For some, the drug may~     improve red blood cell counts and decrease the need for red cell transfusions. Knowledge~     gained in the study may help people in the future.~   "
261954|NCT00120640|"~     The goal of our research will be to determine the effectiveness of 17~     alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with~     progesterone is emerging as the standard of care for prevention of preterm delivery in~     asymptomatic patients at high risk for preterm birth due to a prior preterm delivery. Our~     goal is to evaluate whether or not progesterone is also effective in reducing preterm birth~     in symptomatic patients.~   "
261955|NCT00120627|"~     With ongoing war in Iraq, the incidence of posttraumatic stress disorder (PTSD) in combat~     veterans is increasing. Creation, implementation, and testing of new and innovative~     interventions are needed to provide additional options for enhancing the mental health of~     those with PTSD. Surveys indicate that veterans are interested in complementary approaches to~     health care. The purpose of this study is to determine the efficacy of the Mantram Repetition~     Program (MRP) delivered as a brief, 6-week, complementary and portable intervention. It~     includes frequent, silent repetitions of a mantram (mantra), a word or phrase with spiritual~     associations, to manage PTSD symptoms and improve quality of life military veterans with~     trauma.~   "
261956|NCT00120614|"~     The purpose of this study is to determine whether beginning an enriched~     educational/behavioral program for parents of premature infants, very early in the Neonatal~     Intensive Care Unit (NICU) stay, and lasting until the child is 3 years old, has beneficial~     results for both the parents and their infants.~      The hospital phase of the program gives parents an understanding of what to expect in the~     NICU environment; physical characteristics and needs of their premature baby; and how and~     when to best support their infant's development during this time. The information given~     during the home phase of the program continues with information specific to the growth and~     development and the effective parenting of an infant/toddler who has been born prematurely.~      It is believed that this information will help decrease parents' stress, anxiety and~     depression levels that can be related to giving birth to a premature infant. It is also~     expected that it will strengthen the mother's and father's ability to parent their premature~     child in a way that will help support their child's brain development and learning ability~     and to also decrease negative behaviors as the child grows.~   "
261957|NCT00120601|"~     The purpose of this study is to compare the effectiveness of two anti-craving medications,~     naltrexone versus acamprosate, in the treatment of alcohol dependence.~   "
261958|NCT00120588|"~     Magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic and/or~     inflammatory cerebral lesions. It is associated with a significant reduction of perinatal~     death and cerebral palsy in some observational studies.~      The objective of the study is to assess if prenatal magnesium sulfate given to women at risk~     of preterm birth before 33 week's gestation is neuroprotective.~   "
261959|NCT00120575|"~     For children undergoing bone marrow transplantation, respiratory failure is a devastating~     complication, with mortality expectations well above 60%. The researchers have devised a~     novel strategy that may greatly improve survival. Hemofiltration, a continuous form of~     dialysis, was designed as a therapy for critically ill patients with kidney failure. A~     semi-permeable membrane removes plasma water and solutes (up to about 35,000 Daltons~     molecular weight). The researchers have treated immuno-compromised children with respiratory~     failure with hemofiltration. Many inflammatory molecules are of a size well below the limit~     of the filter. Hemofiltration might remove a critical amount of this inflammatory material,~     attenuating the unregulated inflammatory response that is central to the development of~     respiratory failure and progression to multiple organ failure and death. The researchers are~     conducting a multi-center trial of early continuous hemofiltration for respiratory failure in~     children following bone marrow transplantation. The researchers will analyze blood and~     ultrafiltrate using sensitive proteomic methods to detect several inflammatory biochemicals~     known to be active in this disease, looking for evidence that early active hemofiltration~     alters the inflammatory response. The researchers will test whether `early` hemofiltration~     produces greater survival from respiratory failure in this vulnerable population.~   "
262042|NCT00119457|"~     The purpose of this study is to determine whether TTP889 prevents venous thromboembolism~     following surgery to repair hip fracture.~   "
261962|NCT00120536|"~     The purpose of this study is to assess the long term safety and effectiveness of three doses~     of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose~     levels in people with type 2 diabetes who have not previously been treated with drug therapy~     to lower their blood sugar.~   "
261963|NCT00120523|"~     The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in~     the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than~     12 months of age compared to topical corticosteroids (TCS).~   "
261964|NCT00120510|"~     Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the~     current standard of care for initial treatment of HIV in most areas of the world. The purpose~     of this study is to determine the best time to start this anti-HIV treatment in~     treatment-naive adults in Haiti.~   "
261965|NCT00120497|"~     Insulin resistance is common among children with low birthweight. Moreover, growth hormone~     treatment for ensuing short stature also causes insulin resistance. Our objective is to~     examine these processes. Insulin resistance has recently been linked to the accumulation of~     stores of fat in muscle cells which can be measured by MRI. We hypothesize that children who~     are short due to low birthweight have increased muscle fat stores, but that growth hormone~     treatment will paradoxically reverse this association. To test this hypothesis, muscle fat~     stores will be measured in children who are short due to low birthweight before and after~     receiving growth hormone therapy. Other parameters linked to insulin resistance (glucose~     tolerance, blood markers, and body composition) will also be assessed. This study may lead to~     ways to increase growth hormone safety and dose limitations.~   "
261966|NCT00120484|"~     Circadian rhythms are 24-hour cycles that influence natural functions in the body such as~     heart rate, blood pressure, and body temperature. Circadian rhythms provide the body with an~     internal clock and affect sleep patterns. The purpose of this study is to determine the~     effects of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.~   "
261967|NCT00120471|"~     To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple~     yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV~     drug approved for use in the United States for the treatment of HIV infected adults. The~     purpose of this study is to determine the safety, tolerability, and blood levels of TDF in~     HIV infected pregnant women and their babies. The study will be conducted at sites in Malawi~     and Brazil.~   "
261968|NCT00120458|"~     This study will determine the effectiveness of the herb black cohosh for treating~     menopause-related anxiety symptoms in women.~      Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to~     placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.~   "
261969|NCT00120445|"~     The objective of the study is to evaluate the results of using air versus expansile gas~     (perfluoropropane) in the treatment of rhegmatogenous retinal detachment by pneumatic~     retinopexy, comparing the retinal reattachment rate and post-operative visual recovery.~   "
261970|NCT00120432|"~     The purpose of this study is to compare the efficacy on pupillary dilation between the single~     dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular~     examination.~   "
261971|NCT00120419|"~     The purpose of the study is to evaluate whether mycophenolate mofetil (MMF) can treat the~     chronic hyperactivation of the immune system and (partly) prevent the decrease of the CD4+~     T-cell count in chronically HIV-1 infected patients who are not treated with antiretroviral~     therapy (ART). The researchers also want to know what the effect is of treatment with MMF on~     plasma HIV-1 RNA; progression of disease (occurrence of AIDS defining events or reaching the~     indication to start ART); and the safety of treatment with MMF in this patient group.~   "
261972|NCT00120406|"~     The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic~     vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in~     reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by~     lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with~     lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm~     long) and will be initiated upon approval by the Food and Drug Administration (FDA).~   "
261973|NCT00120393|"~     Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination~     highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol~     are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in~     combination with current nucleoside reverse transcriptase inhibitors (NRTIs).~   "
261974|NCT00120380|"~     The purpose of this study is to test whether the addition of inhaled iloprost is safe and~     effective in patients with idiopathic pulmonary arterial hypertension who are already being~     treated with the endothelin receptor antagonist bosentan.~   "
261975|NCT00120367|"~     Progressive multifocal leucoencephalopathy (PML) is a rare infectious disease of the brain,~     provoked by the JC virus. It usually occurs in subjects with impaired immune system as during~     HIV infection. To date, there is no specific antiviral treatment susceptible to cure PML. But~     it was shown in the setting of HIV-related PML, that combination antiretroviral therapy~     allows a restoration of the immune system and then might stop the progression of PML.~      The objective of this study is to appreciate the supplementary efficiency brought by an~     association of more powerful antiretroviral molecules including enfuvirtide on the evolution~     of PML. This research program will involve 30 patients in several centres in France. All the~     patients who will participate will receive enfuvirtide during 6 months in association with a~     combination of two or more potent antiretroviral drugs. The total duration of follow-up for a~     patient will be of 1 year.~   "
261976|NCT00120354|"~     This study will evaluate the long-term safety and effectiveness of lamivudine therapy and the~     possibility of stopping therapy in patients whose hepatitis B is chronic, that is, long~     lasting, and which has responded to treatment. Chronic hepatitis B, caused by a virus, is a~     common form of liver disease affecting about 1 million Americans and about 5 percent of the~     world's population. Health effects include a continuous state of being infectious and the~     risk of transmitting hepatitis to other people, symptoms of liver disease, and development of~     cirrhosis-that is, severe damage to the liver-and liver cancer. Lamivudine is a medication~     that blocks hepatitis B effectively but does not make it disappear completely. Scientists~     believe that the immune system must also be active to rid the body of the last traces of~     hepatitis B.~      Patients ages 18 and older who have chronic hepatitis B and are being treated with lamivudine~     may be eligible to participate in this study. They will undergo a medical history and~     physical examination and will be given lamivudine in 100 mg tablets to be taken as one~     tablet, once each day. Patients will be asked to return to the outpatient clinic every 3~     months, when they will undergo a brief interview and measurement of vital signs-such as blood~     pressure, pulse, and body weight. During the visits, they will fill out questionnaires about~     any symptoms or side effects they have, and they will be seen by a doctor and have a brief~     medical history and examination. There will be a collection of blood for complete blood~     counts, liver enzymes, and hepatitis B virus. Extra blood tests may be done to analyze~     patients' immune reactions to hepatitis B. Patients will also receive refills of their~     lamivudine tablets. They will continue to be treated with lamivudine as long as it seems to~     control the hepatitis infection and liver disease.~      At intervals of about 1 year, patients will have ultrasound examinations, lasting about 1~     hour, of the liver and abdomen. Then at intervals of about 5 years, patients will undergo~     liver biopsies, which require a hospital stay of 2 to 3 days. A liver biopsy is done by~     passing a needle through the skin into the liver to obtain a piece of liver about 2 inches~     long and 1/16-inch in diameter. A small amount of bleeding probably occurs with most liver~     biopsies. Internal bleeding is a risk, which may require that the patient stay in the~     hospital a few days longer, for rest, observation and pain medicine. The biopsy provides~     information that proves whether lamivudine is controlling the liver disease and preventing it~     from worsening or progressing to cirrhosis.~      Side effects of lamivudine include fatigue, muscle aches, fever and chills, sore throat,~     nausea, stomach pain or cramps, and diarrhea. Serious side effects are rare, occurring in~     less than 1% of people taking lamivudine. They include inflammation of the pancreas, nerve~     damage, and buildup of lactic acid in the blood. About 25% of patients experience a temporary~     worsening, or flare, of hepatitis during the first few months of treatment. If flares are~     severe, it is important for researchers to determine whether they are caused by resistance to~     lamivudine or by the immune system acting against the hepatitis B virus or another liver~     condition. A flare of hepatitis can also occur when lamivudine is stopped, that is, a~     withdrawal. In such situations, testing for hepatitis B virus levels and other liver~     conditions is important. It may lead to other treatments or stopping lamivudine and taking~     another medication instead. While patients are participating in the study, they will have a~     careful evaluation of their hepatitis and general condition. They may have an improvement in~     their disease as a result of long-term lamivudine therapy.~   "
261977|NCT00120341|"~     The purpose of this research study is to determine if the use of a series of the Anodyne~     Therapy System in-home treatments over a 90-day period will improve peripheral sensation and~     quality of life in persons with diabetes mellitus.~   "
261978|NCT00120328|"~     The purpose of this study is to determine whether avosentan (SPP301) is effective in~     decreasing morbidity and mortality in patients with diabetic nephropathy.~   "
261979|NCT00120315|"~     The purpose of this study is to determine how many chronic users of antisecretory medication~     can stop after a test for a bacteria associated with peptic ulcer disease.~      This is evaluated in a discontinuation trial.~   "
261980|NCT00120302|"~     This study is not being conducted in the US.~      The study consists of a 4 week double blind treatment period. All patients meeting the~     inclusion/exclusion criteria will enter the study at day 0 and be randomized into either~     pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to~     clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an~     unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the~     study.~      Assessments of eligibility include an Investigator's Global Assessment and Pruritus score.~     Treatment history will be collected at baseline and Quality of Life Questionnaires will be~     carried out at every visit.~   "
261981|NCT00120289|"~     The purpose of this study is to determine whether raising good cholesterol with a drug~     based on the vitamin niacin, while lowering bad cholesterol with a statin drug, can prevent~     more heart disease than the statin alone.~   "
261982|NCT00120276|"~     The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the~     safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open~     surgical repair of the mitral valve using an annuloplasty ring or band in patients with~     moderate to severe functional mitral regurgitation.~   "
261983|NCT00120263|"~     Background:Plasma exchange has been suggested to be of theoretical benefit in the treatment~     of acute renal failure at the onset of multiple myeloma. Two small-randomized trials provide~     conflicting evidence.~      Objective: To assess the effect of 5 to 7 plasma exchanges in the treatment of acute renal~     failure at the onset of multiple myeloma.~      Design: Randomized controlled trial with 4 strata (chemotherapy and dialysis dependence) from~     1998 to 2004.~      Setting: Hospital plasma exchange units in 14 major Canadian medical centers.~      Participants: 92 voluntary patients between the ages of 18 to 81 with acute renal failure at~     the onset of myeloma after volume repletion and hypercalcemia.~      Intervention: 5 to 7 plasma exchanges of 50 ml/Kgm of 5% Human Serum Albumin in first 10 days~     plus conventional therapy versus conventional therapy alone.~      Measurements: The primary outcome is a composite measure of death, dialysis dependence or~     Modification of Diet in Renal Disease Study glomerular filtration rate (MDRD GFR) <~     30mg/min/1.73 meter squared at 6 months.~   "
261984|NCT00120250|"~     The purpose of this study is to obtain data investigating the safety and efficacy of~     eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep~     disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine~     correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more~     effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in~     sleep will be associated with improvement in overall PTSD symptoms, and patients with~     PTSD-related sleep disturbances will have abnormal levels of stress hormones.~   "
261985|NCT00120237|"~     This community-based trial will study misoprostol for the prevention of postpartum hemorrhage~     in rural Pakistan. Traditional birth attendants assisting home deliveries will administer~     study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women~     participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables~     will be evaluated.~   "
261986|NCT00120224|"~     This study will investigate the possibility that medical abortion using mifepristone and~     misoprostol - a safe, proven therapy for terminating early first trimester pregnancy - can be~     administered in a manner that is simpler and less costly than that routinely employed in the~     United States.~      The researchers hypothesize that:~        1. Practitioners themselves, based on history and examination but without sonography, are~          able to dependably and correctly determine which patients are eligible for medical~          abortion and which patients either are not eligible or require further evaluation to~          determine eligibility.~        2. Practitioners themselves, based on a symptom diary and low-sensitivity pregnancy test~          but without sonography, are able to dependably and correctly determine when a successful~          medical abortion has taken place and when referral for other possible outcomes should be~          made.~        3. A symptom diary and low-sensitivity pregnancy test are safe and effective means of~          separating those women who could benefit from a follow-up visit from those who do not~          need one.~   "
261987|NCT00120211|"~     This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy~     used in the treatment of head and neck cancer.~   "
261988|NCT00120198|"~     Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma~     (NHL). The study will examine the tolerability and feasibility to the combination of~     Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus~     Rituximab.~   "
261989|NCT00120185|"~     Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients under~     highly active antiretroviral therapy (HAART) with a CD4 cell count over 200/mm3, but its~     activity in patients without antiretroviral therapy is unknown. This study will test the~     efficacy and safety of IL-2 in naïve patients with a CD4 count between 300 and 500/m3.~   "
261990|NCT00120172|"~     Currently there is no one standard of care for older patients with metastatic colorectal~     cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus~     bevacizumab. The study will also gather information on the usefulness and side effects of~     this treatment combination.~   "
261991|NCT00120159|"~     The general objectives of this protocol are to develop a multi-center prospective data~     collection process to identify risk factors for progression of Necrotizing Enterocolitis~     (NEC). These data will be used as a basis for identifying management strategies appropriate~     for further evaluation (randomized controlled trials), to develop evidence-based standards of~     care, and as a tool to facilitate quality-assessment at individual centers through comparison~     of outcomes with the entire database.~   "
261992|NCT00120133|"~     In the proposed randomized double blind cross-over placebo controlled study, the researchers~     intend to investigate if Atorvastatin (FDA approved statin for children) can be used to~     alleviate the symptom of bone pain (acute phase reaction) that is commonly associated with~     initial doses of pamidronate or zoledronic acid, and also the mechanism that underlies this~     proposed beneficial effect of Atorvastatin. The primary outcome studied will be alleviation~     of bone pain by Atorvastatin compared to placebo by visual analogue pain scale in children~     treated with pamidronate or zoledronic acid. The secondary outcome investigated will be~     changes in blood count and γδT cell count, C-reactive protein (CRP) and cytokine levels of~     interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and gamma interferon (γ-IFN)~     following treatment with Atorvastatin compared to placebo.~   "
261994|NCT00120107|"~     The researchers propose a pilot study of the effect of long-term tea intake on~     atherosclerosis. Thirty patients at high risk for cardiovascular disease will be recruited~     and randomized to a six-month period of consumption of 3 cups per day of either tea, supplied~     as black tea solids readily dissolved in hot or cold liquid, or water.~      At baseline and after 6 months, atherosclerosis in the aorta will be assessed using magnetic~     resonance imaging. The primary outcomes of this pilot study will be compliance with tea~     intake and 2 MRI examinations. As secondary outcomes, standard and novel cardiovascular risk~     markers, including inflammatory, prothrombotic, fibrinolytic, vascular and metabolic factors~     will be measured.~      If successful, this pilot study will form the basis for a larger, long-term randomized trial~     to determine the effect of tea consumption on progression of atherosclerosis.~   "
261995|NCT00120094|"~     This is a multi-center, prospective, observational study enrolling 400 patients with~     suspected or certain neurally-mediated syncope, who undergo carotid sinus massage, tilt~     testing and Implantable Loop Recorder (ILR)implantation. In its second phase, which starts~     after the first ILR-documented syncope, the study will register the patient outcome after~     administration of ILR-guided therapy, which is left to the discretion of the physicians. The~     main objective is to verify the value of ILR in assessing the mechanism of syncope and the~     efficacy of the ILR-guided therapy after syncope recurrence.~   "
261996|NCT00120081|"~     The primary objective of this clinical trial is to determine the safety and tolerability of~     the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3~     intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. The~     secondary objective is to make a preliminary evaluation of the immunogenicity of each of the~     3 doses of the vaccine in healthy volunteers.~   "
261997|NCT00120068|"~     Nursing Home Acquired Pneumonia (NHAP) causes excessive morbidity, mortality,~     hospitalization, and loss of function. At any given time, 1.1-2.5% of veterans who reside at~     nursing home care units (NHCUs) and State Veterans Homes (SVHs) are ill with pneumonia.~     Multi-faceted implementation of evidence-based guidelines has been shown to be feasible in~     the private sector. Retrospective studies demonstrate an association between guideline~     adherence and improved survival.~   "
261998|NCT00120055|"~     The aim of this study is to investigate whether the pharmacokinetics of atorvastatin and/or~     its metabolites is altered in patients with confirmed atorvastatin-induced myopathy compared~     to healthy controls.~   "
261999|NCT00120042|"~     Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead,~     severely malformed or in cases of maternal illness. This process is usually conducted~     medically in Australia, using the prostaglandin E1 analogue misoprostol. This prostaglandin,~     although not specifically licensed for use in pregnancy termination, is now a common~     abortifacient with a lot of accumulated experience both within Australia and internationally.~      Since 1996, misoprostol, a synthetic prostaglandin, has been used at King Edward Memorial~     Hospital as the principal agent for second trimester pregnancy termination. This agent is~     administered vaginally, and in its current form and dosage regimen results in 75-80% of women~     delivering within 24 hours. As experience with this agent has grown, it has been observed~     that in approximately 40% of women the placenta is either completely retained or incompletely~     delivered, necessitating operative removal and an increased potential for maternal blood~     loss. In this study, it is planned, in a randomized controlled clinical trial, to evaluate~     three regimens for the management of placental delivery in women undergoing second trimester~     pregnancy interruption. The primary intention of this study is to develop a third stage~     management protocol to reduce the incidence of placental retention in second trimester~     medical pregnancy termination.~      The secondary aim of this study is to assess the ultrasound appearance of the uterus and its~     cavity within 24 hours of second trimester pregnancy termination. The ultrasound appearances~     of the uterus following second trimester pregnancy loss have not been previously investigated~     in detail. Previous ultrasound studies of the term postpartum uterus have demonstrated a high~     incidence of echogenic material within the uterine cavity soon after an uncomplicated vaginal~     delivery. These findings have been of concern as the ultrasound appearances may erroneously~     imply a need for operative intervention. The investigators wish to ascertain if this high~     incidence of echogenic tissue presence is also true in the second trimester. Ultrasound is~     frequently used by clinicians to define placental completeness and the potential requirement~     for surgical curettage. The data from this single sonographic examination of the uterus will~     provide baseline data for a planned longitudinal study of uterine appearances following~     second trimester pregnancy loss and their correlation with clinical symptoms.~   "
262000|NCT00120029|"~     The efficacy of peer counseling for weight loss maintenance is being tested in obese and~     overweight African American breast cancer survivors.~   "
262001|NCT00120016|"~     Epidemiological observations indicate that a Greek-Mediterranean dietary pattern has great~     potential for cancer prevention, but more definitive data on the preventive effects of this~     diet are needed. Two distinct aspects of this eating pattern are the type of fat consumed and~     a high fruit/vegetable intake. If the diet is feasible, it could be used in future clinical~     trials of breast cancer prevention. In this study, women randomly receive either a control~     diet or an intervention diet for 6 months. The intervention diet replaces half of the typical~     American fat intake with foods such as olive oil and nuts. The fruit and vegetable goal is~     7-9 servings/day and includes several categories of fruits, vegetables, and herbs. Blood~     samples are drawn and analyzed for fatty acids derived from fats, micronutrients from fruits~     and vegetables, and markers of oxidative stress. This dietary trial will provide important~     data on the ability of women following typical American eating patterns to change their~     dietary intakes to reflect a Greek-Mediterranean pattern.~   "
262002|NCT00120003|"~     The purpose of this trial is to assess whether the blood pressure lowering agent candesartan~     (an angiotensin receptor type 1 blocker) is effective when given to patients with acute~     stroke and elevated blood pressure.~      Hypothesis:~      AT1 receptor blockade with candesartan in acute stroke will:~        1. reduce the risk of death or major disability at 6 months by a 6% absolute risk~          reduction, relative to placebo.~        2. reduce the risk of the combined event of vascular death, myocardial infarction, or~          stroke during the first 6 months by a 25% relative risk reduction, relative to placebo~   "
262003|NCT00119990|"~     During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of~     up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood~     pressure has been described. The effect upon central hemodynamics is unknown. The researchers~     are investigating the effects of low and high glucose dialysate and icodextrin on cardiac~     output, stroke volume, pulse rate and blood pressure. The researchers have hypothesized that~     the effects seen are induced by vasopressin.~   "
262004|NCT00119977|"~     The purpose of this study is to evaluate the effect of performing a periacetabular osteotomy~     on patients with hip dysplasia.~   "
262005|NCT00119964|"~     The purpose of this study is to determine if an internet-based intervention will be effective~     in improving the lifestyle and weight of an obese employee population.~      The intervention will last 12 months, and includes a weight tracker, a food intake tracker,~     an activity tracker, a calorie balance tool, an electronic discussion board, and electronic~     greeting cards.~   "
262006|NCT00119951|"~     The purpose of this study is to assess the impact of participation in the Association of~     Cancer Online Resources (ACOR) mailing lists on chronic disease management for cancer~     patients, we are focusing on several priority areas. These include factors that influence the~     use of online interventions over time and the effects of patient-provider interactions on the~     use of eHealth interventions (as well as vice versa). We also are breaking new ground in a~     number of important methodological areas related to online survey research.~      Our specific aims are:~        1. Conduct a qualitative analysis of a 10% sample of messages (approximately 5,200)~          obtained over 5 months from 9 ACOR lists to develop a comprehensive set of potential~          chronic disease management outcomes and a fuller understanding of the issues and themes~          that characterize list participation. The content analysis will identify important~          themes and issues in the messages. These themes and issues will help in survey~          refinement and ground our proposed quantitative survey questionnaire items. Survey~          analyses will also be enriched by the qualitative data. Finally, the qualitative~          analysis will stand as an independent body of work.~        2. Conduct a web-based survey of at least 1,680 new ACOR mailing list patient members and~          approximately 1,680 non-patient subscribers to assess the positive and negative effects~          of participation in ACOR lists at one month and four months after joining the list and~          completing a baseline survey.~        3. Disseminate study findings to ACOR leadership, participants and the larger online~          community.~        4. Develop a plan to convert the findings into training, recommendations, tools and~          policies to improve list processes. We aim to answer real world, practical questions~          using methodology that is at once rigorous, practical and ethical. The components are~          inter-related and complementary.~   "
262007|NCT00119938|"~     The purpose of this study is to see if an online program for patients with diabetes helps~     patients improve their self-care (how they take their medications, what they eat, how much~     they exercise, and whether they smoke).~   "
262008|NCT00119925|"~     The purpose of this study is to compare two different strategies to implement the existing~     Guideline programme on Subfertility, as issued by the Dutch Society of Obstetrics and~     Gynaecology (NVOG). Therefore, an innovative patient-directed strategy will be compared to a~     control strategy and effectiveness, costs and feasibility of both strategies will be~     assessed.~   "
262009|NCT00119912|"~     The purpose of this study is to see if screening with flexible sigmoidoscopy (a flexible~     viewing tube) may reduce large bowel cancer and cancer deaths. The researchers also want to~     see if the addition of screening for occult blood in stools may contribute further to this~     aim. Additionally, the researchers also want to see to which extent (and in which direction)~     the study may influence overall endoscopic activity in the general population in the~     screening area and in areas where controlled screening is not established.~   "
262010|NCT00119899|"~     Objective(s) of the proposed study:~        -  The evaluation of the efficiency of 18F deoxyglucose-Positron Emission Tomography~          (FDG-PET) in staging patients eligible for hepatic resection of colorectal liver~          metastases in a randomized clinical multicentre setting.~      Research questions of the proposed study:~        -  What are the effects and costs for patients with liver metastases of colorectal cancer~          indicated for potentially curative hepatic resection, using the conventional diagnostic~          strategy with computed tomography (CT) scan in comparison to the experimental diagnostic~          strategy incorporating FDG-PET scan (CT + FDG-PET scan), based on a health care~          perspective and a time horizon of 9 months.~      More specifically:~        -  Does the experimental diagnostic strategy which includes FDG-PET scan in the diagnostic~          work-up of patients eligible for potentially curative hepatic resection of colorectal~          liver metastases lead to a better disease-free survival at 9 months after hepatic~          resection in comparison to the conventional diagnostic strategy using CT scan without~          FDG-PET scan.~        -  What are the costs of diagnostic and therapeutic care for the two diagnostic strategies~          for patients eligible for potentially curative hepatic resection of colorectal liver~          metastases.~        -  What is the effect of including the FDG-PET scan in the diagnostic work-up of patients~          eligible for potentially curative hepatic resection of colorectal liver metastases after~          hepatic resection, expressed as disease-free survival at 9 months adjusted for quality~          of health (Q-TWIST), in comparison to the use of CT scan only.~   "
262011|NCT00119886|"~     The study seeks to evaluate the effect of botulinum toxin on vulvar vestibulitis (VVS) after~     local injection with Botox, a potential treatment to relieve patients of vulvar pain,~     reducing the need for painkillers, and improving the sexual quality of life of the patients.~   "
262012|NCT00119873|"~     The purpose of this study is to determine the safety of and immune response to an~     experimental HIV vaccine in HIV uninfected individuals.~   "
262013|NCT00119847|"~     The purpose of this study is to determine if opening blocked arteries with heart balloons and~     stents prevents heart rhythm problems in individuals 3 to 28 days after a heart attack.~   "
262014|NCT00119834|"~     The Intermacs registry is a national quality improvement system designed to advance the~     understanding and application of mechanical circulatory support in order to improve the~     duration and quality of life in patients with advanced heart failure.~   "
262015|NCT00119821|"~     To evaluate the effectiveness of lifestyle modification following a smoking cessation program~     in preventing weight gain among hypertensive smokers placed at medical risk by the~     post-cessation weight gain.~   "
262016|NCT00119795|"~     To test the effects of exercise and weight loss on mobility disability of older~     overweight/obese men and women who have evidence of cardiovascular disease or the metabolic~     syndrome.~   "
262017|NCT00119782|"~     Reducing the prevalence of obesity in the population is one of the Healthy People 2010 goals.~     Increased vigilance is required in all age groups in preventing and reversing overweight and~     obesity. On an individual level, behavioral factors that influence body weight include eating~     choices leading to excess calorie intake and physical activity patterns leading to diminished~     calorie expenditure. An imbalance between the two over time leads to increased weight. On a~     population basis, the prevalence of overweight is associated with a myriad of influences,~     including social, behavioral, cultural, and environmental factors as well as genetic and~     physiological factors. For a majority of overweight individuals, restoring a balance between~     energy intake and expenditure is difficult, and therefore there is an increasing emphasis on~     preventing obesity on a population level. The long-term goal of this research is to prevent~     further increase in rates of obesity in the population. In the adult population of working~     age, a majority of the day is spent in the worksite, suggesting that interventions at the~     worksite level may offer the opportunity for success in this age group. It is anticipated~     that this project will yield important contributions to the understanding of obesity~     prevention.~   "
262018|NCT00119769|"~     The purpose of this study is to investigate the effect of low-dose human growth hormone~     therapy on immune status and fat morphology.~   "
262043|NCT00119444|"~     The purpose of this study is to examine the blood flow in acetabulum after periacetabular~     osteotomy by Positron Emission Tomography (PET).~   "
262020|NCT00119743|"~     The purpose of this study is to assess the efficacy in young children in preventing acute~     otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza,~     following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary~     vaccination in the first year of life, with booster dose in the second year of life.~     Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo~     (hepatitis A vaccine).~   "
262021|NCT00119730|"~     -  The purpose of this study is to find out whether combining a short course of~          chemotherapy (Fludarabine, Mitoxantrone and Rituximab) followed by Zevalin will be~          effective in treating relapsed mantle cell lymphoma.~        -  The secondary purposes of the study are to determine the safety and to evaluate whether~          there is additional benefit from Zevalin therapy following the chemotherapy.~   "
262022|NCT00119717|"~     The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for~     use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow~     to the brain and potentially reduce the damage caused by stroke.~   "
262023|NCT00119704|"~     The purpose of this study is to determine whether Botulinum A toxin is effective in the~     treatment of tennis elbow (lateral epicondylitis).~   "
262024|NCT00119691|"~     The researchers hypothesize that the addition of nesiritide to standard therapy will prevent~     worsening of renal function in patients admitted to the hospital with decompensated heart~     failure and renal dysfunction relative to standard therapy alone.~   "
262025|NCT00119678|"~     The purpose of this clinical research study is to learn whether Abatacept can treat and~     prevent lupus flares; specifically, in patients with active lupus flares in at least one of~     three organ systems: skin (discoid lesions); inflammation of the lining of the heart~     (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or~     inflammation of more than 4 joints (arthritis). All participants will receive prednisone or~     prednisone-equivalent treatment in combination with study medication. The safety of this~     treatment will also be studied.~   "
262026|NCT00119665|"~     The researchers propose a Phase II randomized, double-blind, placebo-controlled trial of 180~     healthy postmenopausal women experiencing at least 5 hot flashes per day or 35 hot flashes~     per week. Women will be randomized to one of three arms: 4.5 grams/day (dry weight of~     extract) of MF101, 9.0 grams/day (dry weight of extract) of MF101 or placebo for 12 weeks.~   "
262027|NCT00119652|"~     The purpose of this study is to determine whether quetiapine is effective and safe in the~     acute treatment of bipolar depression and whether the effect is maintained when treatment is~     continued.~   "
262028|NCT00119639|"~     This is a 400 mg (2 x 200 mg tablets) sorafenib single dose, open-label study being conducted~     to compare the pharmacokinetics of plasma and urine and safety of sorafenib in subjects with~     severe, moderate, and mild renal impairment with those exhibiting normal renal function.~   "
262029|NCT00119626|"~     This study will determine if NXY-059 will reduce functional disability from an acute stroke.~     The study is designed to look at both overall recovery and recovery of motor function, for~     example muscle strength and coordination.~   "
262030|NCT00119613|"~     The purpose of this study is to evaluate whether increasing or maintaining hemoglobin~     concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy~     in subjects with previously untreated extensive-stage small cell lung cancer (SCLC),~     increases survival.~   "
262031|NCT00119600|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG~     114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects~     receiving multicycle chemotherapy.~   "
262032|NCT00119587|"~     The purpose of this study is to compare once a week and once every other week darbepoetin~     alfa on the change in hemoglobin levels between the screening/baseline period and the~     evaluation period (weeks 25-30). This study will also assess the change in mean hemoglobin~     over 4 week intervals, instability of hemoglobin concentrations, darbepoetin alfa dosing~     requirements and red blood cell transfusions.~   "
262033|NCT00119574|"~     Policy makers and consumers are increasingly concerned about the quality and efficiency of~     care provided to individuals with severe, chronic illnesses such as schizophrenia. These~     illnesses are expensive to treat and present significant challenges to organizations that are~     responsible for providing effective care. Occurring in 1% of the United States population,~     schizophrenia accounts for 10% of permanently disabled people, and 2.5% of all healthcare~     expenditures. Clinical practice guidelines have been promulgated. Schizophrenia is treatable~     and outcomes can be substantially improved with the appropriate use of antipsychotic~     medication, caregiver education and counseling, vocational rehabilitation, and assertive~     treatment. However, in the VA and other mental health systems, many patients with~     schizophrenia receive substandard care. Methods are needed that improve the quality of usual~     care for this disorder while being feasible to implement at typical clinics.~      To date, most efforts to improve care for schizophrenia have focused on educating clinicians~     or changing the financing of care, and have had limited success. We believe a more~     fundamental approach should be tried. While there are many potential strategies, experience~     in chronic medical illness and mental health support the efficacy of specific approaches.~     Collaborative care models are one such approach. They are a blueprint for reorganizing~     practice, and involve changes in division of labor and responsibility, adoption of new care~     protocols, and increased attention to patients' needs. Although collaborative care models~     have been successful in other chronic medical conditions, they have not yet been studied in~     the treatment of schizophrenia.~      We have developed a collaborative care model for schizophrenia that builds on work in other~     disorders, and includes service delivery approaches that are known to be effective in~     schizophrenia. The model focuses on improving treatment through assertive care management,~     caregiver education and support, and standardized patient assessment with feedback of~     information to psychiatrists. This project, EQUIP (Enhancing Quality Utilization In~     Psychosis) is implementing collaborative care and evaluating its effectiveness in~     schizophrenia.~   "
262034|NCT00119561|"~     The primary goal of the study is documentation of effectiveness of telephone support groups~     to reduce caregiver burden and stress. Caregivers who participate in intervention (Telephone~     Support) should experience lower levels of stress, burden and health care utilization (lower~     use of psychotropic drugs, fewer scheduled/unscheduled medical visits, lower rates of~     institutionalization, more efficient use of time in managing care recipient problems)~     compared to those caregivers in Usual Care.~   "
262069|NCT00119041|"~     This study seeks to evaluate and document the processes of outreach consultation through~     joint-clinics via teleconferencing as an intervention for system improvement in care delivery~     and management of diabetes mellitus (DM) at a Community Based Outpatient Center (CBOCs).~   "
262081|NCT00118885|"~     The purpose of this trial is to evaluate the effects of Tai Chi Chih versus Health Education~     on shingles immunity in older adults as measured by unstimulated and vaccine-stimulated~     responses. The secondary goal of the study is to determine the effects of Tai Chi Chih versus~     Health Education on measures of health functioning, depressive symptoms, and health behaviors~     in the elderly.~   "
262035|NCT00119548|"~     Background: HIV testing is cost-effective in unselected general medical populations, yet~     testing rates among those at-risk remain low, even among those with regular primary care. HIV~     rapid testing is effective in many healthcare settings but scant research has been done~     within primary care settings, nor within the US Department of Veteran's Affairs Healthcare~     System.~      Objectives: We evaluated three methods proven effective in other diseases/settings: Nurse~     standing orders for testing, streamlined counseling, and HIV rapid testing.~      Design: Randomized, controlled trial with three intervention models: Model A (traditional~     counseling/testing); Model B (nurse-initiated screening, traditional counseling/testing);~     Model C (nurse-initiated screening, streamlined counseling/rapid testing).~      Participants: 251 patients with primary/urgent care appointments in two VA clinics in the~     same city (one large urban hospital, one freestanding outpatient clinic in a high HIV~     prevalence area)~      Measurements: Rates of HIV testing and receipt of results; sexual risk reduction; HIV~     knowledge improvement.~      Results: Testing rates were 40.2% (Model A), 84.5% (Model B), and 89.3% (Model C) (p=<.01).~     Test receipt rates were 14.6% (Model A), 31.0% (Model B), 79.8% (Model C) (all p=<.01).~     Sexual risk reduction and knowledge improvement did not differ significantly between~     counseling methods.~      Conclusions: Streamlined counseling with rapid testing significantly increased testing and~     receipt rates over current practice without changes in risk behavior or post-test knowledge.~     Increased testing and receipt of results could lead to earlier disease identification,~     increased treatment and reduced morbidity/mortality. Policymakers should consider streamlined~     counseling/rapid testing when implementing routine HIV testing into primary/urgent care.~   "
262036|NCT00119535|"~     The study's primary objective is to determine whether the PRSS improves the optimal timing of~     photocoagulation in diabetic patients in VA. Secondary objectives include assessing if the~     program: (1) leads to improved compliance with retinopathy screening and surveillance visits;~     (2) improves patient and provider satisfaction with VA diabetic eye care; (3) reduces eye~     care visit rates among diabetics receiving eye care at VA; (4) decreases health care resource~     utilization; and (5) improves the cost-effectiveness of eye care for patients with diabetes~   "
262037|NCT00119522|"~     Brief Summary Detailed Description Background: A multitude of risk factors for falling has~     been reported for the elderly, however many of these risk factors are not applicable to~     persons with a spinal cord injury, who use a wheelchair for mobility. The objectives of this~     study are to: (1) describe the incidence and prevalence of tips, falls, and fall-related~     injuries in SCI; (2) describe the epidemiology of the fall event (person, time, place, and~     activity); (3) describe any injuries associated with a fall, including the mechanism and~     nature of the injury, severity of injury, as well as treatment required; (4) determine the~     risk factors related to falls and fall-related injuries in SCI, and develop a model for~     predicting falls and fall-related injuries in SCI; (5) determine healthcare utilization as~     well as direct and indirect costs associated with fall-related injuries in SCI; and (6)~     describe patient-perceived short- and long-term consequences of falls in SCI. The data~     collection for this study was completed on March 31, 2007, and data analysis is in final~     phase.~      Objectives: The objectives of the study are to describe: (1) the incidence and prevalence of~     wheelchair tips, falls, and fall-related injuries; (2) epidemiology of event; (3) injuries~     associated with event, including mechanism, nature, severity of injury and treatment~     required; (4) determine risk factors and develop a model for predicting tips and falls; (5)~     determine healthcare utilization and direct and indirect costs; and (6) describe perceived~     short- and long-term consequences of falls in SCI.~      Methods: This is a prospective cohort study. Data was collected through patient surveys,~     medical records, and VA databases. Baseline information includes risk factors (e.g., user~     characteristics, wheelchair features, wheelchair activities, etc.) and physical environmental~     data. Monthly follow-up calls tracked tips, falls, and injuries.~      Status: Recruitment ended on April 1, 2006 with a total of 702 subjects, and data collection~     was completed on March 31, 2007. The Data Safety Monitoring Board for this study conducted~     its final meeting on September 17, 2007. Data has been analyzed and 17 manuscripts are~     currently in development.~      Impact: While much is known about falls in elderly, there is a lack of understanding of the~     epidemiology of wheelchair-related falls. Our project is expected to identify previously~     unaccounted for factors that predispose persons with SCI to falls and fall-related injuries.~     This study will result in the creation of a model for predicting falls and fall-related~     injuries in SCI. The predictive model will be used to develop intervention strategies~     targeting modifiable risk factors. Eventually, we will test this predictive model with other~     vulnerable veteran populations. Findings from this study wil be used to develop an instrument~     to identify fall risk in persons with SCI.~   "
262038|NCT00119509|"~     The study compares the psychosocial outcomes of different management strategies for women~     with minor atypia (including ‘HPV effect’) detected on Pap smears: conventional management (a~     repeat Pap smear at 6 months) versus Human papillomavirus (HPV) DNA testing, a new method~     proposed for the management of minor atypia and the informed choice of either management~     supported by a decision aid.~      The study examines women’s informed preferences for each of these options and compares the~     psychosocial outcomes in women who are or are not given the choice of management.~      HPV DNA testing offers considerable changes to the management of women with minor atypia and~     there is evidence from the USA which suggests that the use of HPV DNA testing as a triage~     strategy is effective for women within this group (Solomon et al 2001). The introduction of~     HPV DNA testing may bring both benefits and harms to women. These harms and benefits are not~     well understood. Examination of the psychosocial outcomes of HPV DNA testing compared to~     conventional management and women’s preferences for each is needed to guide decisions~     concerning HPV DNA testing in cervical screening in Australia and also internationally.~   "
262039|NCT00119496|"~     Asthmatic smokers display a blunted response to both inhaled and oral corticosteroid~     treatments and are at increased risk for exacerbations and near fatal asthma. The prevalence~     of smoking in asthmatics runs between 20-30%. Therefore, new, more efficacious treatments are~     required.~      Recent work has demonstrated a mechanism which may explain steroid resistance. A commonly~     used drug called theophylline can reverse this steroid resistance in laboratory studies.~     Another commonly used drug, rosiglitazone can reverse smoking induced lung inflammation in~     laboratory studies.~      The investigators aim to study the effects of these drugs on smoking asthmatics' lung~     function and other parameters including quality of life and asthma control.~   "
262040|NCT00119483|"~     Male hypogonadism is a clinical situation characterized by a low serum testosterone level in~     combination with a diversity of symptoms and signs such as reduced libido and vitality,~     decreased muscle mass, increased fat mass and depression. Similar symptoms in combination~     with subnormal testosterone levels are seen in some elderly men. Low testosterone levels are~     associated with known cardiovascular risk factors, and men with diabetes and stroke have~     lower testosterone levels than healthy men. Even though several publications have suggested~     that testosterone treatment in hypogonadal men may have beneficial effects, it is still~     uncertain if testosterone substitution in the aging man is indicated. Despite this~     uncertainty the sale of testosterone has increased enormously the last few years.~      We hypothesize that older men with subnormal testosterone levels have a varying degree of~     dysfunction/symptoms both physically and mentally, and that these dysfunction/symptoms can be~     improved with testosterone treatment.~   "
262041|NCT00119470|"~     This trial examines the role of EUS-FNA (Oesophageal Endoscopic Ultrasound with Fine Needle~     Aspiration) as an endoscopic technique for the mediastinal staging of patients with lung~     cancer.~      Patients will be randomized to either conventional surgical technique or EUS-FNA.~   "
262044|NCT00119431|"~     A multicentre study to investigate pharmacokinetics, clinical efficacy and safety of~     nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the~     treatment of hereditary angioedema (HAE) will be performed. This study KB2003.01 consists of~     three parts, part A pharmacokinetics (phase II), part B treatment of attacks of angioedema~     (phase III) and part C prophylactic use of C1 inhibitor (phase III). Part B + C will provide~     data on the efficacy of C1-esteraseremmer-N.~      The changes in the manufacturing process of C1-esteraseremmer-N, compared to Cetor® (the~     currently marketed C1-inhibitor product), nanofiltration and omission of hepatitis B~     immunoglobulin, most likely will not affect tolerability. The nanofiltration will provide~     more safety regarding viruses.~      In part A, the pharmacokinetics of C1-esteraseremmer-N in patients with hereditary angioedema~     will be compared with the current registered product, Cetor®, in a randomised, blinded~     cross-over design. This study has to provide evidence that changes in the manufacturing~     process have not affected pharmacokinetics. In addition, this study provides data on safety~     of C1-esteraseremmer-N.~   "
262045|NCT00119418|"~     This study tests to see if TU 025 Keishi Bukuryo Gan reduces the frequency and severity of~     hot flashes in post-menopausal American women. This study will also estimate the best dose~     amount and determine the common short-term side effects and risks.~   "
262046|NCT00119405|"~     Nucleoside reverse transcriptase inhibitors (NRTIs) are a class of anti-HIV (Human~     Immunodeficiency Virus) drug that can be an important part of an HIV treatment regimen.~     Because anti-HIV therapy may have negative side effects, there is a great need to carefully~     study HIV infected patients on such regimens. One negative side effect observed in many HIV~     infected patients is lipoatrophy, a condition that results in fat loss in the body. It is~     unclear if NRTIs also have a role in the development of mitochondrial toxicity, a condition~     that affects the body's ability to produce energy. The purpose of this study is to observe~     the effects of an NRTI-based, protease inhibitor (PI)-sparing drug regimen on fat loss in HIV~     infected, treatment-naive adults.~      Study hypothesis: The initiation of NRTI-containing, PI-sparing therapy will inhibit~     mitochondrial DNA (mtDNA) synthesis and lead to a decrease in mtDNA content in adipose~     tissue, skeletal muscle and peripheral blood mononuclear cells (PBMCs), will cause~     deterioration in mitochondrial function, will increase fat apoptosis and oxidative damage~     biomarkers, and will lead to progressive decrease in body fat content.~   "
262047|NCT00119392|"~     Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells~     and either kill them or carry cancer-killing substances to them without harming normal cells.~     Giving monoclonal antibodies, low doses of chemotherapy, such as fludarabine phosphate, and~     low dose total-body radiation therapy before a donor peripheral stem cell transplant helps~     stop the growth of cancer cells and also stops the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune cells and help~     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     cyclosporine or mycophenolate mofetil after the transplant may stop this from happening~   "
262048|NCT00119379|"~     HIV lipoatrophy is a condition marked by fat loss; it occurs in many patients taking~     antiretroviral (ARV) therapy that includes nucleoside reverse transcriptase inhibitors~     (NRTIs). Lipoatrophy may be related to mitochondrial toxicity, a condition that can damage~     the heart, nerves, muscles, kidneys, and liver, and can affect the body's ability to produce~     energy. NucleomaxX is a food supplement consisting of a sugar cane extract high in~     nucleosides, which are building blocks that may counteract the negative effects of NRTIs.~     Tenofovir disoproxil fumarate (TDF) is an NRTI that may cause less lipoatrophy than other~     drugs in its class, such as zidovudine (ZDV) or stavudine (d4T). The purpose of this study is~     to determine whether nucleoside supplementation with NucleomaxX and substitution of TDF for~     ZDV or d4T in an ARV regimen can reverse fat loss caused by mitochondrial toxicity in HIV~     infected adults.~      Study hypotheses: 1) The substitution of TDF for d4T or ZDV in patients with HIV lipoatrophy~     will result in an increase in mitochondrial DNA content in fat, skeletal muscle, and~     peripheral blood mononuclear cells (PBMCs), which in turn will lead to an improvement in~     mitochondrial function as assessed by electron transport chain (ETC) and oxidative~     phosphorylation pathway (OXPHOS) activity. The latter should lead to a decrease in fat~     apoptosis and in mitochondrial and lipid oxidative damage biomarkers. 2) Supplementation with~     uridine (via NucleomaxX) will increase mtDNA content in adipose tissue and increase body fat~     content.~   "
262049|NCT00119366|"~     This phase II trial studies the side effects and best dose of iodine I 131 monoclonal~     antibody BC8 when given together with fludarabine phosphate, total-body irradiation, and~     donor stem cell transplant followed by cyclosporine and mycophenolate mofetil in treating~     patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other~     places in the body and usually cannot be cured or controlled with treatment. Giving~     chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor~     peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and~     helps stop the patient's immune system from rejecting the donor's stem cells. Also,~     radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find~     cancer cells and carry cancer-killing substances to them without harming normal cells. When~     the healthy stem cells from a donor are infused into the patient they may help the patient's~     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving fludarabine phosphate and total-body irradiation before the transplant together with~     cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.~     Giving a radiolabeled monoclonal antibody together with donor stem cell transplant,~     cyclosporine, and mycophenolate mofetil may be an effective treatment for advanced acute~     myeloid leukemia or myelodysplastic syndromes.~   "
262070|NCT00119028|"~     Based on the published evidence, collaborative care for depression is both necessary and~     sufficient for improving care and outcomes for depressed patients in primary care settings.~     The Translating Initiatives in Depression into Effective Solutions (TIDES) project, upon~     which ReTIDES is based, developed a VA-adapted version of collaborative care through input~     from veterans, clinicians, and managers. The initial TIDES project resulted in a clinically~     stable and effective model as tested in seven primary care practices in three VISNs. This~     positive result provided the basis for spreading and sustaining the TIDES model and~     initiating the study of national implementation strategies and issues.~   "
262050|NCT00119340|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy~     before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune system and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving cyclosporine and mycophenolate~     mofetil after transplant may stop this from happening.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of fludarabine,~     total-body irradiation, and donor stem cell transplant followed by cyclosporine and~     mycophenolate mofetil and to see how well they work in treating patients with chronic~     myelogenous leukemia.~   "
262051|NCT00119314|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, docetaxel, and capecitabine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel~     and capecitabine works in treating patients with cancer of unknown primary origin.~   "
262052|NCT00119301|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate, trimetrexate glucuronate, and~     leucovorin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of trimetrexate~     glucuronate when given together with methotrexate and leucovorin in treating patients with~     refractory or recurrent osteosarcoma.~   "
262053|NCT00119262|"~     This phase II trial is studying how well giving bevacizumab together with combination~     chemotherapy works in treating patients who have undergone surgery for breast cancer that has~     spread to the lymph nodes. Monoclonal antibodies, such as bevacizumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may~     also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in~     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving bevacizumab together with more than one~     chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.~   "
262054|NCT00119249|"~     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. This phase II trial is studying how well~     sorafenib works in treating patients with stage III or stage IV melanoma that cannot be~     removed by surgery~   "
262055|NCT00119236|"~     This phase I trial is studying the side effects and best dose of 17-AAG and irinotecan in~     treating patients with locally advanced or metastatic solid tumors. Drugs used in~     chemotherapy, such as 17-AAG and irinotecan, work in different ways to stop the growth of~     tumor cells either by killing the cells or by stopping them from dividing. Giving more than~     one drug (combination chemotherapy) may kill more tumor cells.~   "
262056|NCT00119210|"~     The purpose of this small preliminary study is to determine whether it is feasible to recruit~     women smokers who have just delivered a baby and are not breastfeeding into a study that~     would test whether starting bupropion, a smoking cessation medication, after a baby's birth~     helps a postpartum woman to stop smoking.~   "
262057|NCT00119197|"~     The purpose of the study is to confirm the safety and immunogenicity of the oral killed~     bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal,~     India.~   "
262058|NCT00119184|"~     The purpose of this study is to examine whether spinal anesthesia affects the chances of~     successful external cephalic version (ECV) of a breech presenting fetus.~      Two study groups will be included; one will receive spinal anesthesia, the other will not.~     The non-spinal group will be permitted to cross over if ECV procedure is painful.~      The main outcome is success of ECV.~   "
262059|NCT00119171|"~     The purpose of this study is to determine the dose regimen of Ispinesib in combination with~     capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion~     every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest~     period. A patient may continue to receive treatment as long as they are benefiting from the~     treatment. Blood samples will be taken at specific times to measure the amount of both drugs~     in your body at specific times after the drug is given. Blood samples will also be taken for~     lab tests such as complete blood counts and clinical chemistries. Physical exams will be~     performed before each treatment with Ispinesib. During the treatment phase, the patients will~     undergo regular assessments for safety and clinical response.~   "
262060|NCT00119158|"~     Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is~     to treat acute flares using topical medications. The two most common classes of topical~     medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin~     inhibitors.~      Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there~     may be a synergistic effect of the combination therapy. Therefore, a combination therapy may~     provide a faster resolution of severe skin lesions and consequently reduce the duration of~     the topical corticosteroid treatment. Another benefit of the combination therapy maybe the~     use of a lower potency corticosteroid to achieve the same degree of clearance.~      The hypothesis of this trial is that the combination of the two agents will lead to faster~     clearance than the single agent of topical corticosteroids.~   "
262071|NCT00119015|"~     Some people with nasal allergy symptoms continue to have symptoms even after treatment with a~     nasal steroid spray. The purpose of this study is to see if these patients are helped by~     adding another medication (montelukast) to their treatment compared to placebo (a substance~     that looks like the active medication but does not contain the drug).~   "
262082|NCT00118872|"~     This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given~     in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are~     being weaned from breastfeeding.~      Study hypothesis: Use of the probiotic bacteria LGG at the time of weaning will lessen the~     impact of faltering growth in babies living in the slums of Pakistan.~   "
263323|NCT00102115|"~     The purpose of this study is to determine the safety and tolerability of Talaporfin Sodium~     (LS11) Photodynamic Therapy in patients with late stage Age-Related Macular Disease (AMD).~   "
262061|NCT00119145|"~     Case management is one of the key strategies for malaria control in most endemic countries.~     Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial~     drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety~     and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised~     malariometric indices in order to make appropriate treatment policies.~      Artemisinin-based combination chemotherapies have been documented to consistently produce~     faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria~     than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and~     artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin~     combination chemotherapies produced at industrial scale, with good manufacturing practices~     and already used in Africa. Several African countries, including Ghana, are therefore~     introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such~     a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two~     combinations under different epidemiological conditions is urgently needed to guide informed~     decisions on the most appropriate antimalarial first-line treatment regimen.~      This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination~     therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised,~     non-inferiority drug trial.~      The study results will inform future decisions on first- and second-line treatments for~     uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.~   "
262062|NCT00119132|"~     Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach~     to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this~     approach can be very effective. Although the results of these studies suggest that IPTc with~     sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe~     intervention for reducing the burden of malaria and anaemia in children in high transmission~     areas with short transmission periods, there is no data from areas with long transmission~     periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and~     malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred~     forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to~     receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or~     bimonthly), SP or placebo. The children will also be followed to determine if there is any~     rebound in the incidence of severe malaria and anaemia in the year following IPTc.~   "
262063|NCT00119119|"~     The fibrosis of liver is a complication of chronic hepatitis C. There is actually no~     established treatment for fibrosis of the liver. Pentoxyphilline and tocopherol may have an~     activity on fibrosis. The aim of the study is to analyse the efficacy and the safety of the~     combination with pentoxyphilline and tocopherol (12 months) on liver fibrosis, in patients~     with chronic hepatitis C, who are non-long-term responders, or with intolerance or~     contra-indication to interferon-alfa and ribavirin.~   "
262064|NCT00119106|"~     The primary goals of this study are to assess the safety and efficacy of daily tenofovir to~     prevent parenteral HIV infection among injection drug users (IDUs). Assessment of changes in~     HIV associated risk behaviors, adherence to study drug, and, among IDU who become~     HIV-infected during the trial, evaluation of HIV viral load set point, CD4 counts, genetic~     characterization of infecting HIV viruses, and antiretroviral resistance will also be done.~   "
262065|NCT00119093|"~     The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and~     tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of~     Uganda. This study is evaluating how well this program reduces illness and prolongs the life~     of participants, changes sexual behavior, influences levels of adherence to medication,~     affects aspects of perceived stigma by participants and their communities, and other~     operational components of the program including cost-effectiveness. This study is evaluating~     the hypothesis that frequent home visits by a trained lay person with a standard~     questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell~     count measurements.~   "
262066|NCT00119080|"~     The purpose of this study is to determine whether the new meningococcal conjugate vaccine~     (MCV4) can reduce asymptomatic carriage of meningococcal bacteria, and thus decrease the~     transmission of these bacteria in the population.~   "
262067|NCT00119067|"~     Anthrax Clinical Trial Objectives:~      To assess whether:~        -  Anthrax vaccine (AVA or BioThrax, BioPort Corp. Lansing MI) administered by the~          intramuscular (IM) route elicits antibody responses that are not inferior (i.e.,~          non-inferior) to that achieved by the currently licensed schedule.~        -  BioThrax administered by the IM route and containing fewer numbers of doses elicits~          antibody responses that are not inferior (i.e., non-inferior) to that achieved by the~          currently licensed schedule.~        -  Differences in reactogenicity exist between the IM and subcutaneous (SQ) administration~          of BioThrax.~      Additionally for the final report we will assess whether:~        -  Occurrence of adverse events following AVA administration is influenced by selected risk~          factors.~   "
262068|NCT00119054|"~     Patients treated at Veterans Affairs (VA) medical centers are older and have multiple chronic~     conditions. Two of the most common conditions in the VA population are hypertension (HTN) and~     Type 2 diabetes (DM). Unfortunately, DM and HTN have few perceptible symptoms on a daily~     basis that motivate patients to comply with treatment recommendations and lifestyle changes.~     Thus, serious complications and long-term adverse outcomes are common in both of these~     conditions.~      Home telehealth is a general term used to describe the delivery of health care services to~     the patient's home using audio, video, or other telecommunications technologies. Although~     home telehealth offers a number of theoretical advantages, few well-designed controlled~     clinical trials have been conducted to establish efficacy and cost benefit. Furthermore,~     projects to date have focused on special populations, e.g., heart failure or mental~     illnesses. Since home telehealth may hold the most promise for individuals dealing with~     multiple chronic illnesses, there is a need for population-based studies addressing the needs~     of patients in primary care settings.~      Care coordination, as defined by the VHA Office of Care Coordination, is a process of~     assessment and ongoing monitoring of patients using home telehealth to proactively enable~     prevention, investigation, and treatment that enhances the health of patients and prevents~     unnecessary and inappropriate use of resources. Care coordination embeds technology into a~     care management process. This results in the right care, at the right time, in the right~     place.~   "
262072|NCT00119002|"~     This study will compare a single dose of oral dexamethasone to placebo in a multicenter,~     randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis~     (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any~     other routine therapy used at that center. No current standard therapy is withheld, and no~     additional tests or other treatments are part of the study.The primary hypothesis is that~     dexamethasone will be more effective than placebo in preventing hospital admission. The~     secondary hypotheses are that dexamethasone will decrease respiratory scores and possibly the~     duration of the disease when compared to placebo, and that dexamethasone will be as safe and~     as well tolerated as placebo.~   "
262073|NCT00118989|"~     Specific Aims:~        -  To determine if curcuminoids modulate cellular proliferation as measured by~          proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with~          previously resected adenomatous colonic polyps.~      Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects~     with previously resected sporadic adenomatous colonic polyps.~        -  To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the~          colorectal mucosa of subjects with previously resected adenomatous colonic polyps.~      Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously~     resected sporadic adenomatous colonic polyps.~        -  To determine if curcuminoids modulate COX-2 expression as measured by~          immunohistochemical assays in subjects with previously resected adenomatous colonic~          polyps~      Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with~     previously resected sporadic adenomatous colonic polyps.~        -  To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids~      Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.~   "
262074|NCT00118976|"~     The primary aim is to evaluate the anti proteinuric effect of increasing doses of the ACE~     inhibitor, lisinopril: 20, 40 and 60 mg daily in type 1 diabetic patients with hypertension~     and diabetic nephropathy.~      The secondary aim is to evaluate the effect on blood pressure (24 hour ambulatory blood~     pressure) and kidney function (glomerular filtration rate (GFR)).~      The tertiary aim is to evaluate differences in response to treatment according to~     ACE/insertion/deletion (ID)-genotypes and other genetic variants in the genes of the renin~     angiotensin system.~   "
262075|NCT00118963|"~     Aim:~      The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular~     events in obese patients with type-2-diabetes treated with metformin compared with other~     hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese~     patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when~     diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of~     cardiovascular events, the use of metformin for this sub-group of patients might be more~     beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents~     (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence~     exist for choosing the optimal class of OHA to be combined with insulin. The aim of the~     project is therefore to investigate the effect of metformin vs. an insulin-secretagogue~     (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular~     risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone.~      Methodology:~      Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese~     (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment~     with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart~     30/70, BIAsp30) for a period of 12 months.~   "
262076|NCT00118950|"~     Background: Metformin is the first drug of choice in obese patients with type-2 diabetes~     (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In~     non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim~     of this study was to evaluate the effect of metformin versus an insulin-secretagogue,~     repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in~     non-obese patients with T2DM.~      Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96~     non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only~     treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d).~     followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months~     with a one month wash-out between interventions.~   "
262077|NCT00118937|"~     Ninety percent of patients with type-1-diabetes will develop late-diabetic complications in~     the eyes, kidneys, nervous- or cardiovascular-system. Poor glycaemic control is an important~     risk-factor for development of these late-diabetic complications. The Diabetes Control and~     Complications Trial (DCCT)-study showed, that improved glycaemic control can prevent the~     development and progression of these late-diabetic complications. Until now treatment with~     insulin- and diet-therapy has been the only treatment-modalities available to improve the~     glycaemic control in patients with type-1-diabetes. A substantial number of these patients~     still have long-standing poor glycaemic control despite intensive treatment with insulin- and~     diet-therapy.~      The antidiabetic drug metformin has shown to be able to improve the glycaemic control in~     combination with insulin and furthermore reduce both mortality and the risk of developing~     cardiovascular disease in patients with type-2-diabetes.~      Only few small studies have investigated the effect of treatment with metformin in patients~     with type-1-diabetes. These studies have suggested a positive effect of metformin in these~     patients too.~      Method:~      100 patients with type-1-diabetes with persistent poor glycaemic control i.e. HbA1c > 8.5%~     during the last 12 months are eligible. Patients are treated for one month with placebo.~     Hereafter half of the patients will be treated with metformin and the other half continues~     with placebo for 12 months both as add-on therapy. All patients are continuing ongoing~     treatment with insulin throughout the study. Before and after the start of treatment with~     metformin the effect on glycaemic control and other known risk-factors for development of~     cardiovascular disease i. e. blood-pressure, fasting lipids, urine-albumine-excretion,~     endothelial dysfunction, inflammation, fibrinolysis etc. is assessed.~      This study will show if treatment with metformin can improve the glycaemic control and hereby~     the prognosis of patients with type-1-diabetes with persistent poor glycaemic control despite~     intensive treatment with insulin- and diet-therapy. This group of patients suffers the~     highest risk of developing late-diabetic complications with reduced quality of life and~     life-expectancy as a consequence.~   "
262078|NCT00118924|"~     Tick-borne encephalitis (TBE) is a viral illness common in the Northern Hemisphere,~     especially Europe and Asia. TBE infection may lead to central nervous system problems and~     death. The purpose of this study is to test the safety of and immune response to a TBE~     vaccine in healthy adults. The vaccine is related to a live attenuated virus developed~     against dengue virus infection.~   "
262079|NCT00118911|"~     This study will determine the efficacy of cognitive behavioral therapy in treating adults~     with attention deficit hyperactivity disorder.~   "
262080|NCT00118898|"~     Currently, the preferred anti-HIV regimens used in the United States consist of two~     nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse~     transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being~     approved, alternative regimens need to be tested to determine if new drug combinations have~     increased effectiveness in treating HIV. The purpose of this study is to test the safety,~     tolerability, and effectiveness of four different regimens in HIV-infected adults who have~     never taken anti-HIV drugs.~   "
262083|NCT00118859|"~     This pilot study will determine the feasibility of enrolling participants from different~     populations for a larger study of low back pain (LBP) treatment. In addition, this study will~     assess the effectiveness of data collection instruments and procedures as well as utilize~     feedback from participants to refine a future study.~   "
262084|NCT00118846|"~     The purpose of this study is to determine whether soy supplements can reduce hardening of the~     arteries in postmenopausal women. This study will also determine the effects of soy~     supplements on mental processes, bone mineral density, and breast tissue density.~   "
262085|NCT00118833|"~     This study will determine whether the herbal product St. John's wort is safe and effective in~     treating generalized social anxiety disorder (GSAD).~      Study hypothesis: Hypericum perforatum (St. John's wort) is more effective in treating GSAD~     than placebo.~   "
262086|NCT00118820|"~     Despite over 50 years of antibiotic use and multiple clinical investigations (>50), no~     definitive studies exist to confirm or refute the use of systemic antibiotics to prevent~     postoperative inflammatory complications after third molar (M3), aka wisdom teeth removal.~     Among patients having M3s extracted, does the administration of systemic prophylactic~     antibiotics when compared to placebo, decrease the rate of postoperative inflammatory~     complications? The first specific aim of the study is to implement a randomized,~     placebo-controlled clinical trial to determine if systemic prophylactic antibiotics, when~     compared to placebo, decrease the rate of postoperative alveolar osteitis (AO) after M3~     extraction. For this proposal, postoperative AO is the primary outcome variable.~      The second specific aim is to implement a pilot study using a randomized, placebo-controlled~     clinical trial to determine if systemic prophylactic antibiotics, when compared to placebo,~     decrease the rate of postoperative infection after M3 extraction. For the purposes of this~     proposal, postoperative infection is a secondary outcome variable. Based on sample size~     estimates, we believe it will be necessary to implement a multi-year trial to address the~     second specific aim definitively. As such, we will use the experience and preliminary results~     derived from this clinical trial to develop and implement a future large scale clinical~     trial.~      The third specific aim is to identify risk factors associated with postoperative inflammatory~     complications in order to develop a model to predict if the prophylactic administration of~     antibiotics will prevent the postoperative inflammatory complications of alveolar osteitis~     and infection following the removal of M3's.~      The long-term goal of this project is to provide compelling clinical evidence to support~     recommendations regarding the use of systemic antibiotics in this setting and alter clinical~     practice based on the results of a well-done, definitive clinical investigation.~   "
262087|NCT00118807|"~     The purpose of this trial is to compare the effectiveness of three combination treatments for~     uncomplicated malaria when given in operational settings, without supervision of doses other~     than the first dose.~   "
262088|NCT00118794|"~     Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with~     glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic~     effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent~     to which the risks associated with the use of the drug in settings without G6PD screening~     might outweigh the benefits to malaria treatment. The investigators will evaluate, in~     operational settings, the safety and effectiveness of Lapdap and coartemether~     (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10~     years of age.~   "
262089|NCT00118781|"~     This is a multinational, double-blind, placebo-controlled trial designed to assess whether~     iseganan, applied topically to the oral cavity, can prevent ventilator-associated pneumonia~     among patients who are intubated and mechanically ventilated and survive for up to 14 days.~   "
262090|NCT00118768|"~     This Phase II study is being conducted in treatment-naive patients (no previous antiviral~     therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety~     and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug~     approved by the Food and Drug Administration for the treatment of Hepatitis C infection).~   "
262091|NCT00118755|"~     This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral~     Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a~     first-line treatment in patients with locally advanced or metastatic colorectal cancer.~     Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid)~     on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each~     3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1~     and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment~     was 1-2 years, and the target sample size was 100-500 individuals.~   "
262092|NCT00118742|"~     This two-arm study will assess the efficacy and safety of a long-term calcineurin~     inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an~     orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g~     twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The~     anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500~     individuals.~   "
262093|NCT00118729|"~     Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following~     allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of~     allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly~     referred to as hay fever, it is characterized by sneezing, nasal congestion and pruritus,~     rhinorrhea, and pruritic, watery, red eyes. The purpose of this study is to evaluate the~     onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus~     vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed~     following a single dose of treatment in controlled pollen concentrations in an allergen~     challenge chamber.~   "
262094|NCT00118716|"~     During this study, your child will need to attend up to 5 office visits and maintain regular~     telephone contact with the clinic. Certain office visits will include physical exams, medical~     history review, exercise challenge test (walking/running on a treadmill), electrocardiogram~     (ECG) tests, and lung function tests. All study related medications and medical examinations~     are provided at no cost. All study drugs are currently available by prescription to patients~     4 years and older.~   "
262095|NCT00118703|"~     The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg~     once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent~     subjects (12 years of age and older) with vasomotor rhinitis (VMR).~   "
262096|NCT00118690|"~     During this study, your child will need to attend up to 5 office visits and maintain regular~     telephone contact with the clinic. Certain office visits will include physical exams, medical~     history review, exercise challenge test (walking/running on a treadmill), electrocardiogram~     (ECG) tests, and lung function tests. All study related medications and medical examinations~     are provided at no cost. All study drugs are currently available by prescription to patients~     4 years and older.~   "
262156|NCT00117871|"~     The primary purpose of this study is to evaluate the effectiveness in adults of 2 different~     strengths of resiquimod gel applied to common wart(s) five times a week for up to 12 weeks.~      A second purpose is to evaluate the safety of the drug.~   "
262097|NCT00118677|"~     This trial is aimed at studying the safety of long term supervised treatment interruption in~     HIV infected patients with CD4 over 350/mm3 and plasma HIV RNA under 50 000/mL. Another aim~     of this study is to assess the immunological and virological factors associated with the~     duration of treatment interruption.~   "
262098|NCT00118664|"~     The purpose of this study is to learn how blood clotting substances respond in children with~     septic shock, low platelet counts, and multiple organ failure (MOF) treated at different~     institutions.~      Multiple organ failure can be related to an infection producing septic shock, in which~     substances released in the blood cause poor blood flow to the organs. The number of platelets~     circulating in your child's blood stream is also decreased (this is called~     thrombocytopenia) as a result of this condition. Research has shown that certain substances~     in the part of the blood known as plasma (the clear liquid part of the blood not including~     the red blood cells but holding blood clotting factors) can cause the organs to work poorly.~     The investigators would like to compare these blood responses in children with this~     condition, receiving a variety of different treatments, for multiple organ failure in other~     medical centers around the world. The investigators hope to enroll 80 patients into the~     study.~   "
262099|NCT00118651|"~     This was a study involving the emergency department and outpatient clinics of the David Grant~     United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of~     age or older with acute respiratory tract symptoms and positive chest radiographs from~     October 1, 2004 through May 31, 2005 were included as positive cases. Controls were randomly~     selected from a review of negative chest radiograph reports with a clinical history of an~     acute respiratory illness over the same time period. Equivocal radiographs were treated as~     positive cases. Patients were excluded if they were under the age of 18 or in suspected cases~     of hospital-acquired or aspiration pneumonia.~      The six clinical indicators included cough, sputum production, temperature, heart rate,~     respiratory rate, and findings on physical examination. Abnormal vital signs were defined as~     temperature of 100.5 degrees Fahrenheit (38 degrees Celsius) or greater, heart rate greater~     than or equal to 100 beats per minute, and respiratory rate greater than 20 breaths per~     minute. Positive physical examination findings consisted of the presence of crackles,~     decreased breath sounds, dullness to percussion, egophony, or rhonchi.~   "
262100|NCT00118638|"~     The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every~     3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered~     as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid~     malignancies.~   "
262101|NCT00118625|"~     Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities~     of an allergen extract to an allergic patient, is a curative approach which directly treats~     the underlying allergic disease. Tree MATA MPL has been developed to provide pre-seasonal~     specific immunotherapy for patients with an allergy to tree pollen (hay fever).~      The tolerability and immunogenicity of Tree MATA (allergen modified with glutaraldehyde and~     adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a~     bacterial cell surface) is being investigated in this double-blind, randomized Phase IIa~     study in volunteers allergic to birch and hazel and alder pollen.~      Additionally, this study will assess residual allergenicity of the modified birch and hazel~     and alder pollen in the product Tree MATA MPL using skin prick testing in volunteers allergic~     to birch and hazel and alder pollen.~   "
262102|NCT00118612|"~     Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities~     of an allergen extract to an allergic patient, is a curative approach which directly treats~     the underlying allergic disease. Tree MATA MPL has been developed to provide pre-seasonal~     specific immunotherapy for patients with an allergy to tree pollen (hay fever).~      The purpose of this double-blind Phase IIb study is to assess the tolerability and~     immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and~     alder pollen.~   "
262103|NCT00118586|"~     This study will look for abnormalities in a brain of persons affected with spasmodic~     dysphonia, a form of movement disorder that involves involuntary spasms of the muscles in~     the vocal folds causing breaks of speech and affecting voice quality. The causes of this~     disorder are not known. The study will compare results of magnetic resonance imaging (MRI) in~     people with spasmodic dysphonia and in healthy volunteers.~      People with adductor or abductor spasmodic dysphonia and healthy volunteers may be eligible~     for this study. Candidates are screened with a medical history, physical examination, and a~     test called nasolaryngoscopy. For this test, the inside of the subject's nose is sprayed with~     a decongestant, and a small, flexible tube called a nasolaryngoscope is passed through the~     nose to the back of the throat to allow examination of the larynx (voice box). During this~     procedure, the subject is asked to perform tasks such as talking, singing, whistling, and~     saying prolonged vowels. The nasolaryngoscope is connected to a camera to record the~     movements of the vocal folds during these tasks.~      Eligible participants then undergo MRI of the brain. MRI uses a strong magnetic field and~     radio waves instead of x-rays to obtain images of body organs and tissues. For this test, the~     subject lies on a table that slides into the MRI scanner, a narrow metal cylinder, wearing~     ear plugs to muffle loud knocking sound that occurs during the scan. During MRI anatomical~     images of the brain are obtained. Subject may be asked to participate in up to two scanning~     sessions. Each session takes about 1-1/2 hours.~      Participants may also be asked to volunteer for a brain donation program which is optional.~     Information gained from donated tissue may lead to better treatments and potential cures for~     spasmodic dysphonia.~   "
262104|NCT00118573|"~     Objective of the present study is to compare endovascular repair versus surveillance and,~     eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with~     respect to patient survival, AAA rupture and AAA related death risks.~   "
262105|NCT00118560|"~     The purposes of this pilot project are to (a) determine changes in calf muscle blood flow and~     energy supply resulting from calf muscle exercise, and (b) to determine changes in these~     variables resulting from exercise training (walking and calf muscle exercise). This is a~     pilot study to prepare for a larger project in the future. Exercise and exercise training~     should increase blood flow and energy supply to the calf muscles.~   "
262106|NCT00118547|"~     The purpose of this pilot trial is to provide preliminary evidence of the effectiveness of a~     brief behavioral intervention using telemedicine home monitoring to help individuals with~     multiple sclerosis adhere to medications that slow disease progression.~   "
262107|NCT00118534|"~     The primary study objective is to conduct a prospective, randomized controlled clinical trial~     that compares the effectiveness of two approaches for delivering smoking cessation treatment~     for veterans with posttraumatic stress disorder (PTSD). An approach where smoking cessation~     treatment is integrated into mental health care for PTSD and delivered by mental health~     providers (experimental condition) will be compared to specialized smoking cessation clinic~     referral (VA's usual standard of care).~      Secondary study objectives are to (a) compare the cost outcomes and cost-effectiveness of IC~     versus USC, (b) identify treatment process variables that explain (mediate) observed~     differences in smoking abstinence rates for the two study conditions, and (c) determine~     whether cessation from smoking is associated with worsening of symptoms of PTSD and/or~     depression.~   "
262108|NCT00118521|"~     Musculoskeletal conditions account for the third leading cause of health systems expenditure~     in Australia. Patellofemoral pain syndrome or pain about the knee cap is such a condition~     often treated in primary care. Both the individual and community are affected by this~     condition with an estimated 1 in 4 sufferers having problems and pain up to 20 years after~     first being afflicted. Importantly, it interferes with activities such as walking, jogging,~     gym classes and aerobics, which are often prescribed to prevent serious conditions of the~     heart, diabetes and obesity. Hence, it negatively impacts the health and well being of our~     nation.~      Two popular treatment options that are commonly prescribed for the management of~     patellofemoral pain syndrome are physiotherapy and foot orthotics. To date, there is some~     evidence supporting physiotherapy, especially current best practice methods, such as a~     combined program of therapeutic exercise, manual therapy and kneecap taping. There is a lack~     of evidence for the use of orthotics in treating patellofemoral pain syndrome.~      This project will conduct a randomised clinical trial to evaluate the relative benefits of~     orthotics as the sole treatment of patellofemoral pain syndrome and also when combined with~     physiotherapy. Factors associated with predicting the results of orthotic therapy will be~     studied to see if there are any tests that a health care practitioner can perform to provide~     information early on in a consultation regarding possible treatment outcomes. A cost-benefit~     analysis will also be conducted to calculate the relative economic merits of the treatments.~      A tangible outcome of this project will be the development of clinical guidelines for the~     most effective method of treating patellofemoral pain syndrome in primary health care.~   "
262109|NCT00118508|"~     The purpose of this study is to evaluate the effectiveness of once weekly risedronate in the~     prevention and treatment of bone loss in premenopausal and newly menopausal women with breast~     cancer who have received chemotherapy.~      The hypothesis is that bisphosphonate therapy will prevent bone loss at clinically relevant~     sites, such as the hip and spine. The investigators also hypothesize that there will be a~     correlation between biochemical markers of bone turnover and changes in bone mineral density.~   "
262110|NCT00118495|"~     The objective of this study is to evaluate the clinical efficacy and safety of Zestra(TM) in~     women with acquired mixed desire/interest/arousal/orgasm disorders under conditions of home~     usage. The primary efficacy hypothesis will compare the effect of Zestra versus placebo on~     the incidence of successful and satisfactory sexual encounters.~   "
262111|NCT00118482|"~     The main question in the study is whether people taking fludrocortisone are less likely to~     faint than people taking an inactive pill called a placebo.~      Fludrocortisone is a drug that stimulates the body to retain salt and water. The~     investigators know from some studies that it might prevent people from fainting at home and~     in the community, while they are carrying on with their lives. There is some evidence that~     salt and water retention help prevent fainting, but no one has a clear idea about whether~     this is true. This study will try to determine if that is true.~   "
262112|NCT00118469|"~     This study will determine the effectiveness of adding a parent-involved intervention to~     cognitive behavior therapy in reducing depressive symptoms among Latino adolescents with~     depression.~   "
262113|NCT00118456|"~     AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with~     potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has~     an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will~     assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity~     of AEE788 in advanced cancers.~   "
262114|NCT00118443|"~     This study will determine whether a training program designed to help school staff members~     identify adolescents at risk for suicide will increase the number of students who are~     referred to mental health services.~   "
262115|NCT00118430|"~     This study will evaluate the effectiveness of a stepped care approach in treating depression~     and reducing pain.~   "
262116|NCT00118417|"~     This study will determine the effectiveness of different treatments for panic disorder~     symptoms in individuals who still have symptoms after initial treatment with medication.~   "
262117|NCT00118404|"~     This study determined the effectiveness of continuation phase cognitive therapy versus~     antidepressant medication in preventing relapse of depression in people with recurrent~     depression.~   "
262118|NCT00118391|"~     This study will determine the effectiveness of cognitive behavior therapy (CBT) and~     contingency management (CM) in reducing gambling behaviors and other related problems in~     pathological gambling.~      Study hypothesis: Participants who receive CBT and CM will attend more treatment sessions and~     show better outcomes than those who receive CBT alone.~   "
262119|NCT00118378|"~     This study will determine whether modafinil (Provigil®), a medication approved for the~     treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.~   "
262120|NCT00118365|"~     This randomized phase III trial is studying eflornithine and sulindac to see how well they~     work compared to a placebo in preventing colorectal cancer in patients with colon polyps.~     Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming~     back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known~     whether eflornithine and sulindac are more effective than a placebo in preventing colorectal~     cancer~   "
262241|NCT00116766|"~     Isolated minority communities in China use traditional plant-based methods of mosquito~     control. This study is evaluating 4 plants used in this way by monitoring mosquitoes entering~     houses on nights when the plants are being used in this way. A blind, placebo controlled~     study design will monitor plant use and record mosquito species / numbers caught in CDC light~     traps indoors over 3 months.~   "
262121|NCT00118352|"~     This phase II trial is studying the side effects and best dose of alemtuzumab when given~     together with fludarabine phosphate and total-body irradiation followed by cyclosporine and~     mycophenolate mofetil in treating patients who are undergoing a donor stem cell transplant~     for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, a~     monoclonal antibody, such as alemtuzumab, and radiation therapy before a donor stem cell~     transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy~     before or after transplant also stops the patient's immune system from rejecting the donor's~     bone marrow stem cells. The donated stem cells may replace the patient's immune cells and~     help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from~     happening.~   "
262122|NCT00118339|"~     RATIONALE: Chemoprotective agents may protect normal cells from the side effects of~     chemotherapy. Ice chips or saline mouth rinse may lessen the severity or help prevent~     symptoms of mucositis or mouth sores in patients receiving melphalan and autologous stem cell~     transplant for multiple myeloma. It is not yet known whether ice chips are more effective~     than saline mouth rinse in reducing or preventing mucositis.~      PURPOSE: This randomized phase III trial is studying ice chips to see how well they work~     compared to saline mouth rinse in reducing or preventing mucositis in patients receiving~     melphalan and autologous stem cell transplant for multiple myeloma.~   "
262123|NCT00118326|"~     RATIONALE: A bone marrow transplant from a brother or sister may be able to replace~     blood-forming cells that were destroyed by chemotherapy or radiation therapy.~     Colony-stimulating factors, such as G-CSF, cause the body to make blood cells. Giving G-CSF~     to the donor may help the body make more stem cells that can be collected for bone marrow~     transplant and may cause fewer side effects in the patient after the transplant.~      PURPOSE: This phase I/II trial is studying the side effects of donor bone marrow transplant~     and to see how well it works in treating young patients with cancer or a non-cancerous~     disease.~   "
262124|NCT00118313|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system~     in different ways and stop tumor cells from growing. Giving vaccine therapy together with~     imiquimod after surgery may help the body kill any remaining tumor cells.~      PURPOSE: This randomized phase I trial is studying the side effects and best way to give~     vaccine therapy with or without imiquimod in treating patients who have undergone surgery for~     stage II, stage III, or stage IV melanoma.~   "
262125|NCT00118300|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells.~     Internal radiation uses radioactive material placed directly into or near a tumor to kill~     tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when~     given together with radiation therapy in treating patients with locally advanced cervical~     cancer or other pelvic cancer.~   "
262126|NCT00118287|"~     This phase I/II trial studies how well giving azacitidine together with etanercept works in~     treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as~     azacitidine, works in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may~     protect normal cells from the side effects of chemotherapy~   "
262127|NCT00118274|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop~     tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery~     may cause a stronger immune response to kill any remaining tumor cells. It may also prevent~     or delay the recurrence of melanoma.~      PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy~     when given with or without cyclophosphamide and to see how well they work in treating~     patients who have undergone surgery for stage II, stage III, or stage IV melanoma.~   "
262128|NCT00118261|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Erlotinib may help chemotherapy work better by making tumor cells more sensitive to the~     drugs. Giving erlotinib together with combination chemotherapy and bevacizumab may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when~     given together with combination chemotherapy and bevacizumab as first-line therapy in~     treating patients with metastatic colorectal cancer.~   "
262129|NCT00118248|"~     This phase II trial is studying how well tanespimycin works in treating patients with~     inoperable locoregionally advanced or metastatic thyroid cancer. Drugs used in chemotherapy,~     such as tanespimycin, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing.~   "
262130|NCT00118235|"~     This phase II trial is studying how well giving cisplatin and irinotecan together with~     bevacizumab works in treating patients with extensive-stage small cell lung cancer. Drugs~     used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of small~     cell lung cancer by blocking blood flow to the tumor. Giving cisplatin and irinotecan~     together with bevacizumab may kill more tumor cells.~   "
271147|NCT00037284|"~     To explore the immune/inflammatory processes as pathways between depression/exhaustion and~     coronary artery disease (CAD) progression.~   "
262131|NCT00118222|"~     RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active~     when it is exposed to a certain kind of light. When the drug is active, tumor cells are~     killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells.~      PURPOSE: This randomized clinical trial is studying two different light doses of photodynamic~     therapy using porfimer sodium to compare how well they work in treating patients who are~     undergoing surgery for recurrent malignant astrocytoma.~   "
262132|NCT00118209|"~     This randomized phase III trial studies rituximab when given together with two different~     combination chemotherapy regimens to compare how well they work in treating patients with~     diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may~     block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving rituximab together~     with combination chemotherapy may kill more cancer cells. It is not yet known which~     combination chemotherapy regimen is more effective when given with rituximab in treating~     diffuse large B-cell non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying rituximab when given together with two~     different combination chemotherapy regimens to compare how well they work in treating~     patients with diffuse large B-cell lymphoma.~   "
262133|NCT00118196|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer~     cells.~      PURPOSE: This phase II trial is studying how well giving azacitidine together with arsenic~     trioxide works in treating patients with myelodysplastic syndromes or chronic myelomonocytic~     leukemia.~   "
262134|NCT00118183|"~     This randomized phase II trial is studying how well giving docetaxel together with either~     cetuximab or bortezomib works as first-line therapy in treating patients with stage III or~     stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in~     different ways. Some find tumor cells and kill them or carry tumor-killing substances to~     them. Others interfere with the ability of tumor cells to grow and spread. Bortezomib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     docetaxel together with either cetuximab or bortezomib may be effective as first-line therapy~     in treating non-small cell lung cancer.~   "
262135|NCT00118170|"~     This phase I trial is studying the side effects and best dose of sorafenib in treating~     patients with metastatic or unresectable solid tumors, multiple myeloma, or non-Hodgkin's~     lymphoma with or without impaired liver or kidney function. Sorafenib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the cancer. Sorafenib may have different effects in patients who have changes in~     their liver or kidney function~   "
262136|NCT00118157|"~     This phase II trial studies how well giving lapatinib ditosylate together with tamoxifen~     citrate works in treating patients with breast cancer that has spread from where it started~     to nearby tissue or lymph nodes or to other areas of the body and did not respond to previous~     treatment with tamoxifen citrate. Lapatinib ditosylate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast~     cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the~     use of estrogen by the tumor cells. Sometimes when tamoxifen citrate is given, it does not~     stop the growth of tumor cells. The tumor is said to be resistant to tamoxifen citrate.~     Giving lapatinib ditosylate together with tamoxifen citrate may reduce drug resistance and~     allow the tumor cells to be killed.~   "
262137|NCT00118144|"~     This phase II trial is studying how well bortezomib works in treating patients with stage~     IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
262138|NCT00118131|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin~     works in treating patients with stage III or stage IV non-small cell lung cancer.~   "
262139|NCT00118105|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop~     the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and~     oxaliplatin together with bevacizumab before and after surgery may be an effective treatment~     for liver metastases.~      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin~     together with bevacizumab works in treating patients who are undergoing surgery for liver~     metastases due to colorectal cancer.~   "
262140|NCT00118092|"~     This phase II trial is studying how well 17-AAG works in treating patients with metastatic~     prostate cancer that did not respond to previous hormone therapy. Drugs used in chemotherapy,~     such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing.~   "
262141|NCT00118066|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of calcitriol may prevent prostate cancer. It is not yet known~     whether calcitriol is more effective than observation in preventing prostate cancer.~      PURPOSE: This randomized phase II trial is studying how well calcitriol works in preventing~     prostate cancer in patients with prostatic intraepithelial neoplasia.~   "
262242|NCT00116753|"~     The rationale of the study was to evaluate different degarelix dosing regimens for a~     three-month interval that was to produce and maintain castration in prostate cancer patients~     through immediate and prolonged testosterone suppression, and to provide confirmatory~     evidence of the safety of degarelix.~   "
271148|NCT00037271|"~     To scan the genome for obesity in a multi-ethnic sample.~   "
262142|NCT00118053|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving trastuzumab together with~     docetaxel and carboplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel~     and carboplatin works in treating women with stage II, stage III, or inflammatory breast~     cancer.~   "
262143|NCT00118040|"~     Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that may occur in DNA and identify biomarkers related~     to cancer. It may also help doctors learn how genistein or placebo works in patients with~     bladder cancer. This randomized phase II trial is studying genistein or placebo to compare~     how they work in patients who are undergoing surgery for bladder cancer.~   "
262144|NCT00118027|"~     SUMMARY~      Background: Malaria is the leading cause of morbidity and mortality among pregnant women in~     Uganda. Although effective tools for prevention and control of malaria exist, their delivery~     presents a problem. Intermittent presumptive treatment (IPT) with sulfadoxine-pyrimethamine~     (SP) is effective, yet >60% of women in Uganda do not get it as < 40%, attend antenatal care.~     Effective ways of delivering IPT with SP to pregnant women at a community level need to be~     developed. This study assessed whether community based resource persons like traditional~     birth attendants (TBAs), community reproductive health workers (CRHWs), adolescent peer~     mobilizers (APMs) and drug-shop owners (DSV) can distribute IPT with SP to pregnant women.~      Objectives: The objectives of this study were:~        -  To assess community based approaches for delivering malaria prevention to pregnant women~          in Uganda;~        -  To assess community perceptions, beliefs and practices associated with malaria treatment~          and prevention in pregnancy;~        -  To assess whether community based resource persons can deliver IPT to pregnant women and~          reach those most at risk;~        -  To assess the impact of IPT on anaemia and pregnancy outcome;~        -  To estimate cost-effectiveness of the approaches and assess the acceptability and~          sustainability of the approaches.~      Methods: The study was conducted in 5 sub-counties of the Mukono district, situated on the~     shores of L. Victoria in Central Uganda. The district is hyper-endemic for malaria. 25~     parishes with a total population of 75,000 people were used to test the new approaches. Phase~     1 obtained qualitative data on community perceptions, beliefs and practices associated with~     malaria prevention in pregnancy. Phase 2 was an intervention study that assessed distribution~     of IPT to pregnant women by TBAs, CRHWs, APMs and DSVs compared with health units. Pregnant~     women of all parities were enrolled. Key resource persons in each parish were identified to~     sensitise the communities on the intervention. Data was collected regarding: timing of the~     first dose of SP, proportion of women who complete two doses of SP, birth weight of babies,~     proportion of low birth-weight babies, and proportion of adolescent pregnancies. The third~     phase of the study evaluated the sustainability of the approaches.~      Work Plan: The first phase of the study took two months. The second phase took 14-16 months.~     Data analysis was expected to take 12 months.~   "
262145|NCT00118014|"~     The purpose of this study is to assess the extent of symptom remission in patients with~     trichotillomania following treatment with sertraline and/or behavior therapy.~   "
262146|NCT00118001|"~     The purpose of this study is to compare the effects of worry exposure with the effects of~     applied relaxation in patients with generalized anxiety disorder.~   "
262147|NCT00117988|"~     This phase II trial is studying how well 17-AAG works in treating patients with relapsed or~     refractory anaplastic large cell lymphoma, mantle cell lymphoma, or Hodgkin's lymphoma. Drugs~     used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing.~   "
262148|NCT00117975|"~     RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or carry cancer-killing substances to them. Giving more than one~     monoclonal antibody may be a better way to block cancer growth.~      PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab~     works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.~   "
262149|NCT00117962|"~     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal~     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Cetuximab may also make tumor cells more sensitive to~     radiation therapy. Giving pemetrexed disodium, carboplatin, and radiation therapy together~     with cetuximab may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium and~     carboplatin together with radiation therapy with or without cetuximab works in treating~     patients with stage III non-small cell lung cancer that cannot be removed by surgery.~   "
262150|NCT00117949|"~     Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486~     CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both~     studies were to guide dose selection for phase III. In addition, safety and tolerance data~     were generated.~   "
262151|NCT00117936|"~     Treatment for no-option heart patients with coronary artery disease. Procedure includes the~     injection into the heart of a protein growth factor, administered by the Cordis Corp. MyoStar~     injection catheter, to stimulate the growth of blood vessels around blocked coronary~     arteries.~   "
262152|NCT00117923|"~     The primary purpose of this study is to evaluate the effectiveness in adults of four~     different strengths of resiquimod gel applied to common wart(s) five times a week for four~     weeks.~      A second purpose is to evaluate the safety of the drug.~   "
262153|NCT00117910|"~     This open-label, multicenter study explored primary and secondary prophylaxis treatment with~     a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with~     high-risk breast cancer receiving myelosuppressive chemotherapy. The primary objective was to~     provide preliminary information on the incidence of protocol defined neutropenic events in~     chemotherapy cycle 1.~   "
262154|NCT00117897|"~     This multicenter, open-label, randomized, parallel study was designed to evaluate whether a~     single fixed-dose subcutaneous (SC) administration of pegfilgrastim or daily administration~     of Filgrastim for absolute neutrophil count (ANC) support would assist in allowing the~     planned dose-on-time (PDOT) of cyclophosphamide, doxorubicin, vincristine, prednisolone~     (CHOP) chemotherapy with Rituximab every 14 days in subjects with aggressive B-cell~     Non-Hodgkin's Lymphoma by reducing the duration of neutropenia and incidence of febrile~     neutropenia.~   "
262155|NCT00117884|"~     The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations~     and dosing regimens on high-risk cervical human papillomavirus infection in women.~   "
262157|NCT00117858|"~     This project is designed to test how direct current (DC) electrical polarization of the brain~     affects language and behavior in patients with frontotemporal dementia (FTD). FTD is the~     second most common form of dementia after Alzheimer's disease. It causes profound~     disturbances of language and other cognitive functions and often results in highly disruptive~     behavior. There is no effective treatment for the behavioral disorder or cognitive deficits~     in FTD. In an earlier study, the researchers used DC polarization to the primary motor cortex~     to enhance prefrontal function in healthy subjects. The experiment resulted in greater verbal~     fluency. In a separate study of five patients with FTD, a similar effect on verbal fluency~     was produced. The object of the current study is to replicate these findings in a larger~     group of patients and to see if the results carry over into real world behavior.~      Participants will be 20 patients aged 35 to 75 years with FTD, referred to the Cognitive~     Neuroscience Section.~      Participants will be tested in two sessions, separated by at least 48 hours. In one session~     they will receive 40 minutes of anodal DC polarization; in the other they will receive 40~     minutes of sham polarization. Participants will be tested for language, memory, and reaction~     time before and 20 minutes after the polarization. For the behavior portion of the study, the~     Neuropsychiatric Inventory will be completed by an investigator with the caretaker on~     admission (covering the preceding week) and again, by telephone, 1 week after discharge, to~     cover the first week home.~      Participants will receive no lasting benefit as a result of the study, but the study is~     likely to yield generalizable knowledge on the effects of DC polarization treatment in FTD.~   "
262158|NCT00117845|"~     Adult T-cell leukemia (ATL) is and aggressive characterized by the presence of cluster of~     differentiation 4 (CD4)/cluster of differentiation 25 (CD25)-expressing T cells~     (interleukin-2 [IL-2]R expressing) in the peripheral blood and in lymphoid and other tissues.~     Denileukin diftitox (Ontak(Registered Trademark)) is a genetically engineered fusion protein~     that targets IL-2-expressing malignancies. Denileukin diftitox interacts with the IL-2R on~     the cell surface, is internalized via endocytosis, and inhibits cellular protein synthesis,~     resulting in cell death within hours to days. The objectives of this study are to determine~     the clinical response to Denileukin diftitox of patients with adult T-cell leukemia (ATL) and~     the safety of Denileukin diftitox in those patients.~      Eligible participants must be 18 years of age or older with chronic, lymphomatous and acute~     forms of ATL, and must be infected with human T-cell lymphotropic virus type I (HTLV1).~      Patients will be treated with 9 mcg/kg/d of Denileukin diftitox intravenously for 5 days~     every 2 weeks. Tumor response will be evaluated after two cycles of treatment. Stable or~     responding patients will continue treatment for a total of 12 months, with evaluations every~     four cycles of treatment. Patients will be treated for two cycles beyond a complete~     remission. The trial uses an optimal two-stage design targeting for a true response~     proportion of more than 30 percent. Nine patients will be treated initially, with expansion~     to 29 patients if a response is seen in 1 of the initial 9 patients treated. Treatment will~     be discontinued if a patient experiences serious side effects.~      A potential benefit is that a patient may undergo partial or complete remission. The research~     may not directly benefit participants, but the results may aid in the treatment of others.~   "
262159|NCT00117832|"~     Eye symptoms of tearing, redness and itching frequently occur in patients with allergic~     rhinitis or hayfever. The purpose of this trial is to study whether placing an allergen (a~     substance that causes allergies) directly in your nose can cause you to have eye symptoms as~     well as nasal symptoms.~   "
262160|NCT00117819|"~     This study involves study participants who have been clinically diagnosed with parkinsonian~     syndrome or who are at-risk for parkinsonian syndrome, have a family history of parkinsonian~     syndrome or exposure to environmental toxins potentially associated with parkinsonian~     syndrome. Participants will have brain imaging to assess dopamine transporter density. The~     imaging data coupled with family history and environmental exposure data may provide~     important information about potential risk factors for parkinsonian syndrome.~   "
262161|NCT00117806|"~     This study involves research about how to help Veterans with spinal cord injury (SCI) gain~     employment. During the first couple of years following SCI, many people are concentrating on~     their rehabilitation and are unable to afford the time for return to work. However, studies~     have shown people often regain the necessary strength and function about two years after SCI~     to resume activities of daily living very similar to what they experienced prior to the SCI.~     Even though many social and legal efforts have been made in the last decade to improve~     chances for people with disabilities to return to work, Veterans with SCI are sometimes~     hindered in finding employment because of age, past work history, and many other factors.~     Other Veterans with SCI are very successful at finding employment either working for~     themselves or working for a company. The investigators know very little about what issues~     Veterans with SCI face when they attempt to find employment after SCI. The study will analyze~     both quantitative and qualitative measures to maximize its findings.~   "
262162|NCT00117793|"~     The fit of the residual limb within a prosthetic socket is a primary concern for many~     amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further,~     amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy~     residual limb tissue; a condition that could be mitigated by the application of negative~     pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual~     limb response to a vacuum suspension system and to measure prosthetic performance in~     comparison to a typical suction suspension system.~      The proposed research plan involves two sets of human subject experiments: (1) prospective,~     randomized cross-over study to quantify performance of a vacuum suspension system as compared~     to a total surface bearing suction socket in terms of pistoning, maintaining limb volume,~     step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen~     tension as a function of vacuum pressure.~   "
262163|NCT00117780|"~     This trial is conducted in Europe. The aim of this research study is to compare the efficacy~     (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection~     compared to insulin detemir twice daily injection administered as basal insulin for the~     treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes~     of hypoglycemia, body weight and side effects).~   "
262349|NCT00115375|"~     PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in~     patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the~     dose providing inhibition of platelet aggregation similar to adults.~   "
262164|NCT00117767|"~     Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily~     in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules~     and pruritus are the primary clinical signs which can be associated with tinea capitis. The~     infection is caused by a relatively small group of dermatophytes in the genera Trichophyton~     and Microsporum.~      Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study~     will evaluate the efficacy and safety of terbinafine in children with tinea capitis.~   "
262165|NCT00117754|"~     Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily~     in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules~     and pruritus are the primary clinical signs which can be associated with tinea capitis. The~     infection is caused by a relatively small group of dermatophytes in the genera Trichophyton~     and Microsporum.~      Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study~     will evaluate the efficacy and safety of terbinafine in children with tinea capitis.~   "
262166|NCT00117741|"~     The purpose of this study is to compare a one year treatment program of Dialectical Behavior~     Therapy (DBT) + suboxone for opiate addicted individuals meeting criteria for borderline~     personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) +~     suboxone.~   "
262167|NCT00117728|"~     This study is designed to test if a sequential protease-inhibitor (PI) - / nevirapine (NVP)~     -based regimen is effective for the treatment of HIV-infected children when previous NVP~     exposure has occurred as part of programs to prevent mother-to-child transmission (pMTCT).~   "
262168|NCT00117715|"~     This is a drug metabolism study in one-year old children involving caffeine and~     dextromethorphan.~   "
262169|NCT00117702|"~     The purpose of this pilot study is to provide preliminary data about the efficacy and the~     safety of the combination of tacrolimus with everolimus in the prophylaxis of the~     graft-versus-host-disease (GvHD) in patients after allogeneic stem cell transplantation.~   "
262170|NCT00117689|"~     This study involves the use of a drug called Thymoglobulin, which is approved in the US to~     treat kidney transplant rejection and in Canada to treat and prevent kidney transplant~     rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced~     doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis~     for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the~     incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion~     criteria are eligible to participate in this study. Approximately 75 study subjects from up~     to 18 transplant centers in the United States and Canada will be enrolled in this 12-month~     study.~   "
262171|NCT00117676|"~     This primary objectives of this study are to compare the efficacy, safety, and tolerability~     of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of~     pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks~     (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to~     480 weeks.~   "
262172|NCT00117663|"~     The purpose of this study is to determine whether cessation of hormone replacement therapy~     for one or two months before a screening mammogram will improve its performance by decreasing~     breast density.~   "
262173|NCT00117650|"~     The purpose of this Phase 2 clinical research study is to examine the safety of an~     experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of~     new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt~     to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD).~      Specifically, this study will enroll patients with severe intermittent claudication (IC)~     which is the stage of PAD in which a patient's walking ability is severely limited, causing~     pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower~     limbs.~   "
262174|NCT00117637|"~     The purpose of the study is to:~        -  Find out if patients receiving BAY43-9006 will live longer without tumor progression~          than those receiving standard therapy with interferon alpha-2a~        -  Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who~          progressed during standard dose treatment with BAY43-9006, and for how long these~          patients live without progression~        -  Find out how long patients live without progression who receive BAY43-9006 after failing~          to respond to standard therapy with interferon alpha-2a~        -  Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks~          kidney tumors and/or their metastases depending on treatment and dosage~        -  Find out if BAY43-9006 has any effect on the quality of life of patients with kidney~          cancer~        -  Find out the level of BAY43-9006 in the blood once per month and any changes in this~          level~        -  Find out whether BAY43-9006 effects are associated with specific biomarkers~   "
262175|NCT00117624|"~     The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a~     front-loading approach with subjects receiving standard weekly dosing in the treatment of~     anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.~   "
262176|NCT00117611|"~     The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair~     (omalizumab), will improve objective and subjective evidence of chronic sinusitis.~   "
262177|NCT00117598|"~     This is an open-label, randomized trial in relapsed refractory subjects with mantle cell~     lymphoma (MCL).~   "
262178|NCT00117585|"~     The purpose of this study is to determine the prevalence and clinical course of orthostatic~     hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to~     initiate a standardized, interdisciplinary treatment plan for patients with OH and determine~     the effect of treatment on the clinical course of OH during their inpatient stay.~   "
262208|NCT00117195|"~     The goal of this study is to investigate neurophysiologic tests that have the potential of~     serving as screening tools for Parkinson's disease. These neurophysiologic tests will be~     administered to individuals with Parkinson's disease and parkinsonian syndrome and validated~     against a healthy control population.~      Specifically, this study will look at changes in motor function, cognitive function,~     handwriting, speech, and olfactory function in individuals with Parkinson's disease,~     individuals at risk for Parkinson's disease and healthy controls.~   "
262350|NCT00115362|"~     The purpose of this study is to investigate whether Efexor (venlafaxine) is effective in the~     treatment of functional dyspepsia.~   "
262179|NCT00117572|"~     The combined use of chemotherapeutic drugs with radiation has proven to be effective in~     improving overall survival and local control among patients with locally advanced head and~     neck cancer. Induction chemotherapy given before receiving local treatment has been shown to~     reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from~     growing or dividing, although it has yet to be determined which agent, or specific~     combination of agents, is most effective in treating head and neck cancer. Docetaxel is a~     drug which has been reported to show promising activity in Phase II head and neck cancer~     studies. Therefore, the purpose of this trial is to compare the effectiveness of induction~     chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in~     patients with locally advanced head and neck cancer.~   "
262180|NCT00117559|"~     The purpose of this study is to evaluate a group psychotherapy intervention and a telehealth~     intervention for veterans undergoing interferon treatment for the hepatitis C virus. It is~     hypothesized that the cognitive behavioral therapy (CBT) condition and the telehealth~     condition will result in significantly improved outcomes, including enhanced adherence,~     quality of life, and psychological status.~   "
262181|NCT00117546|"~     A history of preeclampsia is associated with a low plasma volume and higher sympathetic~     activity. Methyldopa will suppress sympathetic activity to normal values. In this study, the~     researchers will test that effect on the total cardiovascular balance.~   "
262182|NCT00117533|"~     The treatment of choice for chronic hepatitis D is uncertain. The investigators hypothesize~     that pegylated interferon (IFN) alfa-2b in combination with ribavirin (RBV) may be effective~     in the treatment of chronic hepatitis D patients who are also infected by hepatitis B virus~     (HBV). The purpose of this study is to test this hypothesis. The investigators will use~     pegylated IFN alfa-2b in combination with RBV for the treatment of patients with dual chronic~     hepatitis D virus (HDV) and HBV infection. A 24-week course of combination therapy pegylated~     IFN+RBV will be used.~   "
262183|NCT00117520|"~     The study investigated the effect of caffeine on physical performance in healthy citizens~     aged over 70 years. The main hypothesis was that 6 mg/kg caffeine would improve cycling~     endurance at 65% of expected maximal heart rate.~   "
262184|NCT00117507|"~     Thirty patients will be enrolled into this open-label, single-arm trial designed to assess~     the safety and tolerability of oral deferasirox in adult transfusion dependent~     myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study~     will have low or intermediate (INT-1) risk MDS per International Prognostic Scoring System~     (IPSS) criteria. All patients will initiate treatment with 20mg/kg/day deferasirox.~      Deferasirox will be administered orally once per day for 12 months.~   "
262185|NCT00117494|"~     In HIV hypercholesterolemic patients treated with protease inhibitors, some drugs of the~     statin group are used to control cholesterol level. New and potentially more efficient~     statins may interfere with protease inhibitors and hence loose a part of their activity. They~     have thus to be compared with a more established drug of the same class (e.g. pravastatin).~     The protocol compares the efficacy and safety of rosuvastatin and pravastatin.~   "
262186|NCT00117481|"~     This is a 3-arm, multicenter, double-blind, randomized, placebo-controlled study to evaluate~     the efficacy of DR-2001 in endometriosis-related symptoms, primarily nonmenstrual pelvic~     pain, over a 12-week treatment period.~   "
262187|NCT00117468|"~     This is a single-center, open-label, randomized, active-controlled study to compare DR-2011~     to progesterone vaginal gel for luteal phase replacement.~   "
262188|NCT00117455|"~     The purpose of this study is to evaluate the ability of two different fixed doses of~     pegfilgrastim (6mg and 12mg) and a by-weight dose of filgrastim (5ug/kg/day) for the~     mobilisation and collection of PBPCs for autologous transplantation after chemotherapy.~   "
262189|NCT00117442|"~     The purpose of this study is to provide dose-finding information regarding the efficacy and~     kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to~     determine if carboplatin/paclitaxel can be delivered at a reduced cycle interval when~     supported by pegfilgrastim-mobilised PBPCs in whole blood.~   "
262190|NCT00117429|"~     This study will test the safety and immunogenicity of the gp120/NefTat/AS02A vaccine~     candidate in individuals with chronic HIV-1 infection successfully treated with HAART. The~     rationale for this study is based on previous scientific experiments, including data~     indicating that this vaccine can elicit strong HIV-1-specific T cell immune responses in~     humans and monkeys and lead to a retardation of HIV-1 disease progression in animal models of~     HIV-1 infection.~      The HIV vaccine to be administered during this study consists of three recombinant HIV clade~     B viral antigens: the envelope glycoprotein gp120 and two regulatory proteins, Nef and~     Tat.The antigens are formulated in a proprietary adjuvant, AS02A, comprised of two~     immunostimulants in an oil-in-water emulsion (gp120/NefTat/AS02A). The vaccine and the~     adjuvant are manufactured and provided for the study by GlaxoSmithKline Biologicals,~     Rixensart, Belgium. The drugs will be given by intramuscular (IM) injection at a standard~     dose of 20 mg together with 0.5 ml of the AS02A adjuvant.~      Twenty HIV-1 infected individuals will be randomly enrolled into three different study~     groups, receiving either the gp120/NefTat/AS02A vaccine (10 individuals), the AS02A adjuvant~     alone (5 individuals) or a placebo (5 individuals). After obtaining informed consent,~     subjects will have a history and physical exam performed and have laboratory tests to confirm~     they meet all inclusion and exclusion entry criteria. Women of childbearing potential will~     have a pregnancy test prior to each injection of the investigational product. Injections with~     vaccine, adjuvant alone, or placebo will then be performed at weeks 0, 4, and 12. Study~     participants will undergo close monitoring after each vaccination. Blood samples will be~     obtained for immunological assays at study baseline (2 times) and weeks 2, 4, 6, 12, 14, 24,~     and 48. All patients will maintain their antiretroviral treatment regimen during the entire~     study period.~   "
262191|NCT00117416|"~     The purpose of this study is to evaluate the renal perfusion depending on the MAP.~   "
262192|NCT00117403|"~     The purpose of this study is to examine the safety and effectiveness of two anti-oxidant~     treatment regimens in patients with mild to moderate Alzheimer's disease. The anti-oxidant~     treatments include vitamin E + C + alpha-lipoic acid, and Coenzyme Q (CoQ).~   "
262193|NCT00117390|"~     The purpose of this study is to evaluate the optimal technique for determination of the renal~     function of critically ill patients.~   "
262194|NCT00117377|"~     The purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and~     cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy~     volunteers and patients with atopic dermatitis will be studied.~   "
262209|NCT00117182|"~     The purpose of this study is to determine whether the Aridol (mannitol) challenge test can~     predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will~     undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The~     effect on lung function and quality of life will then be measured and correlated with the~     Aridol test result.~   "
262195|NCT00117364|"~     SACCHACHITIN gel, prepared from the waste residue of the fruiting body of Ganoderma tsugae,~     was used in a previous study to enhance skin wound healing in animal models. In the present~     study, the effects of the gel on the activity of matrix metalloproteinases (MMPs) and~     vascular endothelial growth factor (VEGF) as well as on the healing of skin wounds in humans~     are estimated by a clinical trial.~      The hypothesis regarding the poor healing of the wound is the over-expression of MMP and the~     inhibition of the angiogenic factors. From the previous animal study, the effect of~     SACCHACHITIN was to inhibit the activity of MMP and stimulation of VEGF and we try to prove~     the effect over the human wounds from this clinical trial.~      Patients with a poorly healed wound, in which skin graft is clinically indicated, are~     included in this study. The exudates from the wound are collected and analyzed for the~     activity and concentration of VEGF and MMP. The change of the healing process is recorded.~      Positive results are expected from the clinical trial and the patients will get another~     choice for the treatment of the chronic wound other than skin grafting.~   "
262196|NCT00117351|"~     This study will evaluate the safety and efficacy of VELCADE in patients with previously~     treated stage IIIB and IV bronchioloalveolar carcinoma and adenocarcinoma with~     bronchioloalveolar features.~   "
262197|NCT00117338|"~     This study will attempt to find out if the addition of an intravenous form of a drug that is~     already used for treating asthma in children will help resolve asthma attacks faster than~     using the current standard care alone.~   "
262198|NCT00117325|"~     The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg~     once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent~     subjects (12 years of age and older) with vasomotor rhinitis (VMR).~   "
262199|NCT00117312|"~     Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity~     to continue treatment with degarelix under a clinical study until FE200486 was available on~     the market or until the study was discontinued.~      Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of~     FE200486.~   "
262200|NCT00117299|"~     This study evaluates the safety and efficacy of a novel tyrosine kinase inhibitor,~     PTK787/ZK222584, in the treatment of GIST (gastrointestinal stromal tumor) that is resistant~     to imatinib mesylate (Gleevec). The study participants are required to have histologically~     confirmed GIST with prior imatinib treatment for metastatic GIST. is administered orally 1250~     mg/day. Six patients will first enter the study. If clinical benefit is obtained in >1 of 6~     patients, 9 and 30 additional patients will be entered into the protocol in two stages (a~     maximum of 45 patients will be entered). Patients who benefit from the study treatment will~     be treated with PTK787/ZK222584 until treatment failure.~   "
262201|NCT00117286|"~     This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was~     to be treated until he was discontinued or withdrawn from the study, or a marketing~     authorization for degarelix had been obtained.~      The study was terminated when all ongoing participants had been treated for at least 5 years.~   "
262202|NCT00117273|"~     This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy,~     reproductive-aged women using three different regimens of oral contraceptives (OCs). Two~     extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days~     followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg~     for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia~     (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).~   "
262203|NCT00117260|"~     This is a randomized, multicenter, placebo-controlled study to evaluate the effects of~     Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent~     females who have had their menstrual period but now have secondary amenorrhea and also have~     osteopenia. The duration of the study for each patient will be approximately two years.~   "
262204|NCT00117247|"~     The purpose of this study is to evaluate the single dose pharmacokinetics (PK) of~     subcutaneous (SC) darbepoetin alfa in subjects with congestive heart failure (CHF) and~     anemia.~   "
262205|NCT00117234|"~     The purpose of this study was to evaluate the effect of treatment with darbepoetin alfa on~     peak oxygen consumption (peak VO2) in subjects with symptomatic CHF and anemia.~   "
262206|NCT00117221|"~     This study will investigate the spatio-temporal characteristics of brain activity during~     sleep. Functional magnetic resonance imaging (fMRI) studies have shown that in the absence of~     external stimuli, the brain continues to show spatial patterns of activity that resemble~     those during sensory and cognitive tasks. This phenomenon greatly affects the interpretation~     of neuroimaging studies based on positive emission tomography (PET) and fMRI, which rely on~     the contrast between brain activity during a task and activity during rest. In addition,~     resting state activity in itself may reveal information on the large-scale organization of~     neuronal networks and on functional abnormalities related to disease.~      Participants should represent a broad cross section of the healthy adult population. Any~     neurologically and psychiatrically healthy male or nonpregnant female between 18 and 65 years~     old may be eligible.~      Studies will be conducted in the In Vivo NMR Research Center. Concurrent electroencephalogram~     (EEG) and MRI studies will last between 1 and 2 hours. A typical study involves 15 minutes of~     anatomical MRI scanning followed by a 60-minute functional scan during which the subject~     relaxes with eyes closed and is encouraged to sleep while the fMRI/EEG are performed.~     Participants may be scanned 1 to 20 times. No more than 1 scan will be performed per day and~     no more than 20 scans will be performed within a year. During the last 5 to 10 minutes of the~     scan, the participant will open his or her eyes and actively participate in a visual~     stimulation or attention task. The participant's alertness will be measured by a behavioral~     (button-press) response. The visual stimuli (contrast reversing checkerboard displays,~     alternated with uniform grey fields) will be presented using the standard projection system~     available with the MRI scanner. The attention task will involve repeated visual presentation~     of groups of letters and digits; the participant will be asked about the correspondence~     between these groups.~      Magnetoencephalogram (MEG) scans will be performed on some participants. The precise and~     undistorted signals available with MEG will be used to enhance the interpretation of~     alertness and sleep-related characteristics of the EEG signals, which can vary quite~     dramatically across subjects. In addition, the MEG signals will provide preliminary spatial~     localization of the sleep-dependent changes more precisely than is possible with EEG. MRI~     scanner noise will be simulated using tape recordings to allow comparison with the MRI/EEG~     data. MEG scans will last 45 minutes to 2 hours. At all times during any of the brain scans~     the participant will be able to communicate the MRI scientist or MEG/EEG technician and can~     ask to be removed from the device at any time.~      The study will not have a direct benefit for participants. It may be help us learn more about~     brain function, which may lead to better treatments.~   "
262207|NCT00117208|"~     The purpose of this study is to determine the medium term efficacy and safety profile of~     inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In~     particular, we will assess the impact on: lung function; airway inflammation; sputum~     microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs~     of hospital and community care; and cost-effectiveness.~   "
262632|NCT00111566|"~     This trial was designed to examine the efficacy of a brief versus a standard prolonged (18~     hours) infusion of eptifibatide in preventing troponin I release following successful~     coronary stenting.~   "
262210|NCT00117169|"~     The main hypothesis for this study is that the diagnostic approach of pulmonary embolism (PE)~     by evaluation of clinical probability, D-dimer test dosage and multi-detector helical~     computed tomography (hCT) is as safe as the classical approach using clinical probability,~     D-dimer test, lower limb compression ultrasonography and multi-detector helical computed~     tomography.~      The second hypothesis involves evaluating the role of searching distal, i.e. infrapopliteal,~     deep venous thromboses (DVTs) in the diagnostic approach of pulmonary embolism.~   "
262211|NCT00117156|"~     The purpose of this study is to determine the effectiveness of six cycles of concurrent~     fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (MALT) lymphoma,~     marginal zone lymphoma (MZL) or CD5-, CD10-, CD20+ low-grade B cell lymphomas.~   "
262212|NCT00117143|"~     The purpose of this study is to assess the safety, tolerability, and utility of AMG 531 unit~     dosing (µg) in thrombocytopenic subjects with ITP.~   "
262213|NCT00117130|"~     The purpose of this study was to evaluate subject preference for Aranesp® administered once~     monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).~   "
262214|NCT00117117|"~     The purpose of this trial is to prospectively assess the relationship between changes in~     hemoglobin (hgb) and changes in symptom burden associated with anemia in cancer patients~     receiving chemotherapy supported with Aranesp®.~   "
262215|NCT00117104|"~     The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once~     weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either~     recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy~     administered IV thrice weekly (TIW).~   "
262216|NCT00117091|"~     The purpose of this study is to evaluate the percentage of subjects in Australian clinical~     practice continuing treatment with Anakinra (Kineret®) at the end of study week 48 in~     subjects with active RA. The continued use of Kineret® will be based on pre-defined response~     assessment criteria for subjects with active RA.~   "
262217|NCT00117078|"~     The purpose of this study was to evaluate subject preference for Aranesp® administered once~     monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).~   "
262218|NCT00117065|"~     The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to~     maintain hemoglobin (Hb) levels in renal transplant recipients.~   "
262219|NCT00117052|"~     The purpose of this study is to demonstrate that the efficacy of cinacalcet when~     co-administered with the first meal after dialysis is comparable (non-inferior) to the~     efficacy of cinacalcet when administered during the dialysis study visit.~   "
262220|NCT00117039|"~     The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg~     every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and~     maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network~     (NCCN) guidelines).~   "
262221|NCT00117026|"~     The purpose of this study is to determine whether benfotiamine supplementation can reduce~     markers of microvascular complications in type 1 diabetic patients.~   "
262222|NCT00117013|"~     Background:~      HIF-1 is a common mediator of hypoxic and non-hypoxic pathways that affects a transcriptional~     program leading to survival, angiogenesis, migration and invasion of cancer cells. We have~     demonstrated that chronic administration of topotecan inhibits HIF-1alpha expression,~     angiogenesis and tumor growth in human xenografts. Notably, the mechanism by which topotecan~     inhibits HIF-1alpha protein expression is independent of replication-mediated DNA damage,~     suggested a mechanism of action distinct from its cytotoxic effects.~      Objectives:~      This clinical trial is designed to explore the hypothesis that chronic administration of~     topotecan (TPT) inhibits Hypoxia Inducible factor 1alpha (HIF-1alpha) expression and~     angiogenesis in patients with metastatic tumors over-expressing HIF-1alpha.~      Eligibility:~      Adult patients with metastatic solid tumors expressing HIF-1alpha, for whom standard therapy~     does not exist or would likely not be effective, will be evaluated for study eligibility. Due~     to safety concerns, pregnant women and HIV-infected individuals are excluded from this study.~     Prior to enrollment, archival tumor tissue wil be evaluated for the expression of HIF-1alpha~     as assessed by IHC. Only patients who have tumors that express HIF-1alpha and who meet all~     eligibility criteria will be enrolled on this study. Patients will be asked to undergo a~     biopsy to evaluate HIF-1alpha expression before starting treatment and at the end of~     treatment on cycle 2 (day 12 or 13 cycle 2).~      Design:~      Topotecan at the dose of 1.2 mg/m(2) will be administered orally daily x 5 for 2 weeks,~     during a 28 days cycle. Imaging studies including CT, FDG-PET and DCE-MRI will be performed~     at baseline, at the end of treatment on cycle 1 (day 9 or 10), end of treatment on cycle 2~     (day 12 or 13) and then every 2 cycles and will provide information on clinical response as~     well as tumor metabolism and angiogenesis. The repeat scans on day 9 or 10 of cycle 1 will be~     performed solely for research purposes to evaluate for early changes in tumor metabolism and~     angiogenesis. Additional correlative studies include evaluation of mRNA expression of HIF-1~     target genes in tumor tissue, circulating markers of angiogenesis, and measurement of~     circulating endothelial precursor cells (CEP). The goal of this trial is to establish whether~     topotecan inhibits HIF-1alpha and angiogenesis in human cancers....~   "
262223|NCT00117000|"~     The purpose of this study is to determine what effect treatment for one year with~     testosterone and a nutritional supplement, alone and combined, has on the adverse effects of~     under-nutrition in community-dwelling older men and women.~   "
262224|NCT00116987|"~     Of the 19,000 pacemakers implanted across Canada in 2002, 1/3 of them were for patients 80~     years and older. This is the fastest growing segment of our population, yet no study has~     specifically been done in this age group to determine the optimal pacing mode.~      We wish to determine whether dual chamber or single chamber pacing is associated with a~     reduction in emergency room visits or hospitalizations for cardiovascular causes (e.g.,~     congestive heart failure (CHF), atrial fibrillation (AF)) resulting in improved quality of~     life.~   "
262225|NCT00116974|"~     This research project is a multi-center double-blind, parallel, randomized, controlled~     clinical trial design comparing the efficacy of dental scaling and root planing to control~     treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with~     periodontal disease.~   "
262239|NCT00116792|"~     We hypothesize that the combination of the thin-strut MULTI-LINK (i.e. VISION(tm) and/or~     MINI-VISION(tm)) stent and pharmacologic therapy with the oral PPAR-gamma agonist~     rosiglitazone will significantly reduce restenosis after intracoronary stenting in type 2~     diabetic patients. This approach would present a more effective and economical alternative to~     the use of drug-eluting stents to reduce stent restenosis.~   "
262240|NCT00116779|"~     The purpose of the study was to contribute, along with other such dose-finding studies, to~     the identification of the most effective treatment regimen for a one month depot injection of~     degarelix in the treatment of prostate cancer by a rapid and sustained suppression of~     testosterone.~   "
262273|NCT00116350|"~     The purpose of this study is to test whether misoprostol is as effective as oxytocin for~     treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two~     circumstances: 1) where women have received prophylactic uterotonics in the third stage of~     labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.~   "
262226|NCT00116961|"~     This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma~     remains a non-curable disease however, newer medications and their combinations appear to~     provide higher response rates and higher complete response rates than current treatment~     options. One of the new medications in multiple myeloma is Velcade. Preliminary results from~     a study using a combination of Velcade with Doxil have shown high response rates (disease~     reduction). Preliminary results also show that an addition of dexamethasone to Velcade in~     patients not responding to Velcade alone showed improved response rates. This study involves~     treatment with a new combination of three standard medications: Velcade, Doxil, and~     dexamethasone (VDd combination). The proposed combination of all three drugs may improve~     efficacy and response.~      Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple~     myeloma patients who have received at least two prior therapies and have demonstrated disease~     progression on the last therapy. Velcade is still currently under investigation for other~     indications. Doxil is not approved for use in multiple myeloma but is an approved drug for~     use in patients with some other cancers. Several published clinical trials provide evidence~     that Doxil is an active agent in multiple myeloma and it is used in treatment combinations~     for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple~     myeloma, but is not approved by the FDA for that use. The combination of all three drugs is~     experimental (not FDA approved).~      The goals of this study are to determine if this new combination therapy with Velcade, Doxil~     and dexamethasone is an effective treatment and also to determine the side effects that occur~     when this combination treatment is given.~   "
262227|NCT00116948|"~     The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing~     System (ReCap) versus Mallory-Head/Exeter.~   "
262228|NCT00116935|"~     In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST)~     will be randomly allocated in a 1:1 ratio to receive imatinib (Gleevec) either for 12 or for~     36 months following surgery. The study participants are required to have a histologically~     verified GIST with a high risk of GIST recurrence despite complete removal of all macroscopic~     GIST tissue at surgery. The high/very high risk of recurrence is defined as one of the~     following: 1) the largest tumor diameter is over 10 cm; 2) the mitosis count is high (over 10~     mitoses per 50 high power microscope fields, HPFs); 3) the largest tumor diameter over 5 cm~     and the mitosis count is over 5/50 HPFs; 4) tumor spillage has taken place into the abdominal~     cavity at the time of surgery or following spontaneous tumor rupture. All study participants~     will receive imatinib 400 mg/day orally, but the duration of imatinib administration will be~     determined randomly (either for 12 or for 36 months). The study participants will be followed~     up using blood tests and computed tomography (or MRI) of the abdomen. The computed tomography~     examinations will be performed at 6 month intervals for a median of 5 years. A total of 280~     patients will be entered into the study. The study hypothesis is that adjuvant imatinib may~     prevent some of the GIST recurrences, and that there may be a difference in the rate of GIST~     recurrence between the two groups.~   "
262229|NCT00116922|"~     It is now well established that the 21st century will be characterized by a global epidemic~     of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals~     with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing~     to diabetes with a healthy living lifestyle intervention and an insulin sensitizing~     medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral~     glucose tolerance test will be eligible to participate in this study. All participants will~     receive a lifestyle dietary and exercise intervention program. Half of the participants will~     be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is~     commonly used to treat Type 2 diabetes. The primary outcome for this study is the development~     of diabetes. The study is expected to last a total of five years.~   "
262230|NCT00116909|"~     Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck~     cancer in patients who have failed first-line therapy~   "
262231|NCT00116896|"~     This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and~     OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.~   "
262232|NCT00116883|"~     The purpose of this study is to assess the effect of an aqueous nasal spray investigational~     compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA)~     axis system in children 2 to 11 years of age with perennial allergic rhinitis.~   "
262233|NCT00116870|"~     The purpose of this study is to determine whether significant alterations in serum~     lipoproteins as provided by the drug lovastatin can substantially reduce atherosclerosis~     progression or even induce regression.~   "
262234|NCT00116857|"~     This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline~     on depression and cardiac endpoints after myocardial infarction (MI).~   "
262235|NCT00116844|"~     Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for~     60 days in a two-way crossover study with a washout period of 7 days between treatment~     periods.~   "
262236|NCT00116831|"~     The purpose of this study is to test the safety and effectiveness of rosiglitazone against a~     sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels~     of the heart.~   "
262237|NCT00116818|"~     The purpose of this study is to assess the effect of an aqueous nasal spray investigational~     compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system~     in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study~     can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include~     physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and~     allergy skin testing. You will need to complete a daily diary card and spend the night in the~     clinic on 2 occasions to collect urine and blood samples over 24 hour periods.~   "
262238|NCT00116805|"~     The primary objectives of this study are to compare the efficacy, safety, and tolerability of~     tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of~     HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks~     (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to~     480 weeks.~   "
262274|NCT00116337|"~     The purpose of this trial is to determine the efficacy of spinal cord stimulation to produce~     an effective cough in patients with spinal cord injuries.~   "
262243|NCT00116740|"~     This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c~     receptor agonist, in clinical development as a potential treatment for obesity.~      The purpose of this study is to obtain a preliminary assessment of the safety and efficacy of~     APD356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy.~     Subjects who are on concomitant medications for control of hypertension or blood lipids may~     qualify.~   "
262244|NCT00116727|"~     To systematically collect and document use patterns, effectiveness and safety of DMARD~     treatments currently used in the management of rheumatoid arthritis. The primary purpose of~     this study is to estimate the incidence of serious adverse experiences and adverse~     experiences of interest in patients with rheumatoid arthritis (RA) treated with ENBREL®.~   "
262245|NCT00116714|"~     The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1) is designed to~     systematically collect and document use patterns, effectiveness, and safety of DMARD~     treatments currently used in the management of rheumatoid arthritis (RA). It is anticipated~     that study data may help improve the quality of information upon which clinical decisions are~     based.~   "
262246|NCT00116701|"~     Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb)~     ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV~     darbepoetin alfa results in a mean Hb > 11 g/dL.~      Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL~     from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at >~     11 g/dL.~   "
262247|NCT00116688|"~     The purpose of this study is to determine the safety of romiplostim as a long-term treatment~     in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to~     romiplostim, and to evaluate changes in patient reported outcomes due to the use of~     romiplostim. Participants must have previously completed a romiplostim ITP study.~   "
262248|NCT00116675|"~     The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of~     three different strengths of resiquimod gel applied to common wart(s) three times a week for~     four weeks.~      A second purpose is to evaluate the safety of the drug.~   "
262249|NCT00116662|"~     The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of~     three different strengths of resiquimod gel applied to common wart(s) three times a week for~     up to twelve weeks.~      A second purpose is to evaluate the safety of the drug.~   "
262250|NCT00116649|"~     Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the~     sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this~     study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment~     of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso,~     and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The~     secondary objective is to evaluate the effectiveness of treatment with imiquimod in people~     with large surface areas of AK.~   "
262251|NCT00116636|"~     Expected Enrollment: 40 patients~      Study Start Date: June 2005~      Study Objectives:~        -  To conduct a pilot study to assess the safety, tolerability, and antiviral activity of~          Kaletra 400/100 mg taken twice a day (bid) in antiretroviral (ARV)-naïve HIV-infected~          patients at Week 48~      Primary Objectives:~        -  To determine the proportion of patients with HIV RNA <400 copies/mL at weeks 24 and 48~        -  To determine the proportion of patients with HIV RNA < 50 at weeks 24 and 48~        -  To elucidate the specific adverse event (AE) profile of Kaletra single agent therapy~      Secondary Objectives:~        -  To assess the proportion of patients below the limit of quantification (LOQ) at each~          visit. Patients will be observed at baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36,~          40, 44 and 48.~        -  To determine the time to HIV RNA reaching <400 and <50 copies/mL~        -  To determine the time to virologic failure~        -  To assess change from baseline at each visit for HIV RNA and CD4 count at weeks 4, 8,~          12, 24 and 48.~        -  To assess changes in genotype from baseline to time of confirmed virologic failure (2~          consecutive HIV RNA measurements >400 copies/mL after suppressing to <400 copies/mL) or~          at time of treatment intensification.~        -  To characterize changes in lipid and triglyceride concentrations over time and the~          effect of treatment with appropriate drugs (fibrate or statin, if necessary) on these~          elevations.~        -  To evaluate the safety and tolerability of subjects through 48 weeks of drug exposure.~        -  To describe virologic response following intensification in Kaletra single agent~          virologic failures~   "
262252|NCT00116623|"~     The purpose of this study is to investigate the efficacy of Indomethacin compared to~     Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind~     randomized clinical trial. The specific aim of the project is to test the hypothesis that~     Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with~     major complications or death.~   "
262253|NCT00116610|"~     This is a Phase II research study that is designed for patients who have small cell lung~     cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a~     new platinum-based agent that is currently under investigation, in 21-day cycles.~   "
262254|NCT00116597|"~     The purpose of this study is to assess intranodal immunotherapy in locally advanced to~     metastatic melanoma patients (American Joint Committee on Cancer [AJCC] stages IIb to IV).~      For this, the investigators capitalize on their previous melanoma clinical trial (published~     by Zajac P et al in Human Gene Ther 2003) and take advantage of a proprietary recombinant~     vaccinia virus (replication inactivated) expressing 5 minigenes: 3 melanoma associated~     antigens and 2 costimulatory molecules. Immunization with the recombinant vaccinia virus is~     followed by 3 boosts with soluble, synthetic melanoma associated antigens.~      The patients are immunized intranodally (groin lymph node) under ultrasonographic guidance in~     an outpatient clinic. The protocol foresees 2 cycles of immunotherapy for alternate weeks and~     lasts 15 weeks.~   "
262255|NCT00116584|"~     The purpose of this study is to assess whether children with moderate to severe bronchiolitis~     treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven~     nebulization will have improvements in measurements of airway more rapidly than those treated~     with conventional air-oxygen driven nebulization.~   "
262423|NCT00114400|"~     The purpose of this study is to examine whether vitamin B supplementation will reduce the~     progression of early atherosclerosis in individuals over 40 years old and without clinical~     evidence of cardiovascular disease (CVD).~   "
262256|NCT00116571|"~     The purpose of this study is to determine if transurethral photodynamic therapy with~     lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged~     prostate.~      Photodynamic therapy (known as PDT) is a treatment that uses light to make a drug work.~     This means the drug is light-activated. Light-activated drugs do not work until a certain~     color of light shines on the drug. When the drug and the light combine, they react together~     to destroy tissue.~      This study is investigating PDT with lemuteporfin as a possible treatment for an enlarged~     prostate. PDT with lemuteporfin may destroy overgrown prostate tissue and help urinary~     symptoms go back to normal.~   "
262257|NCT00116558|"~     The purposes of the study are to determine the energy balance and evaluate the nutritional~     status of patients with ALS, and to investigate the use of NIPPV as respiratory support to~     treat patients with ALS.~   "
262258|NCT00116545|"~     The purpose of this study is to determine if troglitazone reduces the progression of early~     preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.~   "
262259|NCT00116532|"~     The purpose of this study is to assess the efficacy of Escitalopram in the treatment of~     obsessive compulsive disorder and to determine the optimal treatment dose.~   "
262260|NCT00116519|"~     The purposes of this study are to determine:~        -  The safety of the study medication and any side effects that might be associated with~          it;~        -  Whether the study medication can help patients with low levels of 'good' cholesterol~          (HDL-C) and high blood fats or triglycerides (TG);~        -  How much of the study medication should be given to patients;~        -  How the study medication compares to fenofibrate (Lofibra), a drug used for people with~          low levels of HDL-C and high levels of TG.~   "
262261|NCT00116506|"~     Despite recent advances, most patients with advanced colorectal cancer continue to have a~     poor prognosis. 5-FU, leucovorin, oxaliplatin and bevacizumab is a standard treatment option~     for patients with stage IV colorectal cancer. Fluorouracil (5-FU), leucovorin and oxaliplatin~     are considered traditional chemotherapies that try to stop tumor growth by affecting how they~     divide. Bevacizumab is a therapy to try to block the blood vessels that tumors need to grow.~     It is considered a 'targeted agent'. Erlotinib is another targeted agent, that has been shown~     to be effective in treating lung and other cancers. This trial is assessing the potential~     benefit of adding these second targeted agents to standard treatment.~   "
262262|NCT00116493|"~     The purpose of this study is to test the efficacy of two enhanced regimens (deworming and~     multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months~     of age in Karachi, Pakistan.~   "
262263|NCT00116480|"~     Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment~     with conventional methods. Uncontrolled reports and three small randomised controlled trials~     have suggested that misoprostol may have an additive effect to routine treatment, and there~     is a serious danger that this method will be used widely without research to document the~     effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose~     to test whether 600 μg of sublingually administered misoprostol in women requiring additional~     uterotonics after delivery, and after routine syntocinon to all women during or after~     delivery, has additional effects above the additional conventional uterotonics in reducing~     PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals~     who give consent will be given locally routine treatment for PPH. In addition, they will be~     enrolled by drawing the next of a series of randomised treatment packs containing misoprostol~     or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls~     after enrolment.~   "
262264|NCT00116467|"~     The purpose of this study is to evaluate clinical and laboratory safety associated with the~     administration of GVAX leukemia vaccine and to determine the feasibility of generation of~     GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).~   "
262265|NCT00116454|"~     The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high,~     about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol~     (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection~     of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of~     Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or~     alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.~   "
262266|NCT00116441|"~     The purpose of this study is to evaluate the safety and efficacy of vaccination with~     autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor~     (GM-CSF) producing cell line.~   "
262267|NCT00116428|"~     This trial compares the safety and effectiveness of catheter ablation for PAF with~     antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR®~     THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL®~     catheter was FDA-approved for commercial distribution in the U.S. for treating patients with~     Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial~     infarction. The catheter was approved for use in Europe for endocardial ablation for treating~     cardiac arrhythmias.~   "
262268|NCT00116415|"~     The purpose of this study is to evaluate whether a therapy with an all once daily regimen of~     efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as~     measured by viral load, CD4 counts, adherence, safety, and tolerability.~   "
262269|NCT00116402|"~     The purpose of this study is to evaluate the blood and airway of subjects with mild to~     moderate COPD while undergoing standard treatment.~   "
262270|NCT00116389|"~     The purpose of this study is to assess the 6-month survival rate and safety of talabostat and~     gemcitabine in patients with stage IV adenocarcinoma of the pancreas.~   "
262271|NCT00116376|"~     AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with~     potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It~     has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will~     assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of~     AEE788 in a recurrent GBM population.~   "
262272|NCT00116363|"~     This is a research study to look at the ways in which a treatment called INGN241 can kill~     melanoma cells or help the patient's immune system kill melanoma cells.~   "
262633|NCT00111553|"~     This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with~     cutaneous leishmaniasis.~   "
262275|NCT00116324|"~     The purpose of this study is to examine a specific variation in the genetic code for an~     enzyme (LTC4 synthase) which plays an important role in the airway inflammation associated~     with asthma. We hypothesize that asthmatic patients with this variant gene will have a better~     response to montelukast than patients with the wild type gene, as measured by the ability of~     montelukast to protect against a hypertonic saline challenge.~   "
262276|NCT00116311|"~     The purpose of this study is to determine whether asthmatics have different adenosine~     receptor expression profiles than healthy controls. We hypothesize that asthmatics will have~     increased adenosine receptor expression versus control subjects.~      We also want to study the effects of allergen inhalation on adenosine receptor expression in~     asthmatics. We believe that adenosine receptor expression will be upregulated after allergen~     inhalation.~      Both hypotheses are being tested in sputum and peripheral blood.~   "
262277|NCT00116298|"~     The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T)~     extended release (ER) versus conventional (immediate release [IR]) formulations, each in~     combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed~     Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.~   "
262278|NCT00116285|"~     The purpose of this study is to evaluate the residual allergenicity of the modified ragweed~     pollen in Ragweed MATA MPL (modified pollen allergen tyrosine adsorbate + Monophosphoryl~     Lipid A) by skin prick testing. This is done by a comparison of the wheal response after skin~     prick testing with different concentrations of aqueous native allergen, modified allergen,~     modified tyrosine adsorbed allergen, and Ragweed MATA MPL.~   "
262279|NCT00116272|"~     The purpose of the study is to evaluate the effect of etanercept when used in the first~     trimester of pregnancy with respect to major structural birth defects of newborns. This is an~     observational study only - no investigational product is used.~   "
262280|NCT00116259|"~     There is a scarcity of clinical trials assessing the effects of medications in children with~     bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel~     anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder~     comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group~     trial. Patients were randomized to either aripiprazole or placebo.~      The main hypotheses are:~        1. Aripiprazole will significantly reduce maniac scores compared to placebo~        2. Aripiprazole will significantly reduce ADHD scores compared to placebo~   "
262281|NCT00116246|"~     We propose to conduct a randomised-controlled study to investigate whether adopting~     McRoberts’ position, after 45 minutes of active pushing with no signs of progress, can~     increase the probability of vaginal delivery, preventing the need for forceps or vacuum~     assistance. In our study we will allow 45 minutes of pushing before a further 45 minutes of~     either the same, or our intervention (McRoberts’ manoeuvre).~   "
262282|NCT00116233|"~     This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular~     (cv) surgery.~   "
262283|NCT00116220|"~     This clinical study was to determine if the use of 6 months of total androgen suppression~     (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer~     would improve overall survival.~   "
262284|NCT00116207|"~     The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects~     the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN~     may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.~     Three medications will be tested for their effectiveness in DAN.~   "
262285|NCT00116194|"~     The purpose of this study is to gather preliminary data that will determine the feasibility~     of conducting a Phase III, randomized, controlled trial (RCT) that will provide definite~     evidence in the use of physical exercise to prevent mobility disability in older persons.~   "
262286|NCT00116181|"~     The investigator's laboratory is studying a skin disease known as psoriasis. The purpose of~     this protocol is to study the action and the effects of Etanercept, on psoriasis. This~     medication has been studied extensively and has been found to be effective and safe in the~     treatment of psoriasis. The eligible patient will have 10% of his/her body surface area~     involved with psoriasis vulgaris. This trial is a phase III study to help understand the~     action of the drug etanercept, trade name Enbrel, for the adult patient with moderate to~     severe plaque psoriasis and who is a candidate for internal medications.~   "
262287|NCT00116168|"~     A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses~     of MEDI-528 in to healthy adult volunteers.~   "
262288|NCT00116155|"~     This is a multi-center, open-label, dose finding study of CV787 adenovirus in patients with~     hormone refractory metastatic prostate cancer. Patients will receive treatment intravenously~     at one of up to nine dose levels, each containing three to six patients.~   "
262289|NCT00116142|"~     This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to~     one of the standard treatments (radiation and hormones) for men with high-risk prostate~     cancer.~   "
262290|NCT00116129|"~     This is a 24-week, randomized, double-blind, placebo-controlled, trial to evaluate the~     safety, tolerability and efficacy of an orally administered growth hormone stimulating drug,~     (code named MK-0677) in the treatment of female subjects with primary fibromyalgia. The basis~     for this study is the observation that many fibromyalgia patients are growth hormone~     deficient; an earlier study of injectable growth hormone had shown benefit in this population~     of fibromyalgia patients.~   "
262291|NCT00116116|"~     The purpose of this study is to evaluate whether a therapy with an all once daily regimen of~     stavudine extended release (d4T XR), lamivudine (3TC), and efavirenz (EFV) leads to improved~     outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.~   "
262292|NCT00116103|"~     The purpose of this study is to determine the safety and effectiveness of tacrolimus~     inhalation aerosol in subjects with persistent asthma.~   "
262305|NCT00115934|"~     This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS)~     compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of~     the MBTS to that of the RV-to-PA shunt on the incidence of death or cardiac transplantation~     at 12 months post randomization; and compare the effect of the two shunts on intensive care~     unit (ICU) morbidity, unintended cardiovascular interventional procedures, right ventricular~     function, tricuspid valve regurgitation, pulmonary artery growth, and neurodevelopmental~     outcome.~   "
262293|NCT00116090|"~     This study will evaluate whether therapy that suppresses the immune system given to treat~     inflammatory diseases of the eye is associated with a greater risk of death and of cancer.~     Inflammatory diseases of the eye, including uveitis, scleritis, and mucous membrane~     pemphigoid, are major blinding diseases. For some patients, treatment with corticosteroids is~     not enough to control the diseases. Researchers expect to gain information about whether~     immunosuppressive therapy is suitable for patients and which substances should be avoided.~     Also, the study will evaluate the frequency of short-term complications with~     immunosuppressive therapy as well as benefits that the therapy can bring to treatment of eye~     diseases.~      The medical charts of patients up to age 65 (median age range of 21 to 65) who have had an~     inflammatory, noninfectious eye disease may be examined for this study. A database will be~     constructed through a chart review of patients seen in the uveitis clinic of the National Eye~     Institute since 1977 and three other sites. Patients who are considered exposed to~     immunosuppressive therapies will be compared with two groups: the general U.S. population and~     an internal group of patients with the same inflammatory eye diseases who did not receive~     immunosuppression. Data regarding about 10,000 to 15,000 patients will be collected. Patients~     will not be identified by the chart reviews. The incidence of cancer will be examined as well~     as the outcomes of immosuppressive therapy as measured by control of the eye disease, visual~     sharpness, changes in the use of corticosteroids, and rates of remission-when disease~     symptoms are lessened.~      Also examined will be medical charts of a control group of patients who did not receive~     immunosuppressive therapy for their uveitis. Data on cancer incidence would be more difficult~     to obtain, requiring personal contact with patients. In such situations, patients will be~     contacted by phone or mail, and those providing informed consent will be asked about their~     medical history, including previous occurrence of cancer and other conditions. For patients~     who have died, the researchers will attempt to communicate with the next of kin regarding~     this medical information.~   "
262294|NCT00116077|"~     This study seeks to increase the understanding of dopamine receptor function in the brain~     during major depressive disorder and bipolar depression, as well as genetic changes that may~     be behind changes in those receptors' actions. Dopamine is a natural messenger in the brain,~     involved in reward, motivation, and mood.~      Volunteers aged 18 to 55 who have primary major depressive disorder and those who have~     bipolar depression (20 in each group), who are not HIV positive and do not have AIDS, and who~     are not pregnant or breastfeeding may be eligible for this study.~      A telephone interview will be held, for patients to answer standardized questions about~     psychiatric or medical symptoms they may have experienced during their lifetime. Those~     eligible for the study will undergo interviews and laboratory tests. A psychiatric interview~     and clinical assessment will collect various data. Patients will undergo the following~     procedures and tests:~        -  A brief neurological examination~        -  A one-minute electrocardiogram to measure electrical activity of the heart.~        -  Laboratory tests measuring several substances in the blood and urine.~        -  Pregnancy test.~      A magnetic resonance imaging (MRI) scan will be done to create an image of the volunteer's~     brain structure. The technique of MRI uses a strong magnetic field and radio waves to obtain~     images of body organs and tissues. During the MRI scan, volunteers will lie still on a table~     that will slide into the scanner for 30 minutes and in some cases up to but no more than 90~     minutes. Volunteers will be asked to lie as still as possible during the procedure. Then a~     PET system will create two images of brain blood flow-one of brain dopamine 1 receptor and~     one of dopamine 2/3 receptor binding. Volunteers will be given a radiotracer, a tiny amount~     of a drug that can be detected by a special camera in the PET scanner. A tiny flexible tube~     will be placed in the vein of one arm during each PET scan but during the MRI scan.~     Volunteers will be asked to lie still on the PET scanner table. A mask with large holes for~     eyes, ears, and mouth will be placed over the head, to keep the head from moving. After~     radiotracer injections are given, the PET scanner will create brain images. There may be two~     PET scanning sessions, each requiring about 3 hours of scanning. During only one of these~     there will be breaks. At the end of the scanning session, volunteers will be asked to drink~     several glasses of water and urinate immediately, to reduce radiation exposure to the bladder~     wall.~      Genetic screening will help to enhance researchers' understanding of the role of dopamine~     receptors in depression. A small blood sample, about 2 tablespoons, will be collected, to~     isolate DNA from blood cells. Some of the blood samples or DNA may be stored for future~     studies, but those samples will remain coded, so participants will not be identified. This~     study will not have a direct benefit for participants. However, the results may provide~     knowledge to help people in the future. This study does involve compensation.~   "
262295|NCT00116064|"~     The purpose of this study is to evaluate intranasal lorazepam in paediatric status~     epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common~     paediatric medical emergency compared to our present first line therapy intramuscular~     paraldehyde.~   "
262296|NCT00116051|"~     The purpose of this study is to compare two surface materials (tantalum versus titanium fiber~     mesh) of acetabular components in hip arthroplasty.~   "
262297|NCT00116038|"~     The purpose of this study is to compare metal surface finishes (proximal-coated titanium~     surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.~   "
262298|NCT00116025|"~     The main purpose of this study is to determine the half life of the hormone ghrelin in the~     human body. Other purposes are to investigate the effect of ghrelin on appetite and~     cardiovascular function.~   "
262299|NCT00116012|"~     The primary focus of this study is to explore the safety of a range of doses of rNAPc2 in~     subjects who are managed in hospitals that most typically practice an early invasive strategy~     (catheterization during the index admission). After completion of the ascending dose-ranging~     part of the trial and review of these data by the Data and Safety Monitoring Board (DSMB),~     the maximum tolerated dose of rNAPc2 will be studied in single-arm, open-label panels~     (approximately 25 subjects each) of rNAPc2 with descending doses of unfractionated heparin~     (UFH).~   "
262300|NCT00115999|"~     The purpose of this study is to directly compare the safety and efficacy of intra-thrombus~     alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured~     by a 30 day open vascular free surgery rate.~   "
262301|NCT00115986|"~     The purpose of this research study is to compare how the body reacts to different strengths~     of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a~     subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm.~     Participants will be randomly assigned to receive 1 of 4 different dosages of the vaccine or~     a placebo (dummy) dose of the vaccine. Study procedures will include a physical exam, a urine~     pregnancy test for women, and blood samples. Participants will be asked to complete a diary~     to record temperatures, medications taken, and side effects from the vaccine. Volunteers will~     be involved with study procedures for approximately 7 months. The study will enroll about~     450-470 healthy participants, ages 18-64.~   "
262302|NCT00115973|"~     This trial is conducted in the United States of America (USA). This is an in-patient trial~     investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week~     out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the~     final clinic visit. A subject's participation in this trial would be expected to be up to 16~     weeks.~   "
262303|NCT00115960|"~     The purpose of this study is to determine the safety of and immune response to an~     experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at~     escalating doses of 100, 500, and 1500 mcg). This study will also test the safety of and~     immune response to the HIV-1 gag DNA vaccine plus IL-15 DNA adjuvant given with or without 2~     other adjuvant-containing booster vaccines.~   "
262304|NCT00115947|"~     The purpose of this study is to investigate the effect of terlipressin on myocardial~     perfusion and renal function.~      Hypothesis: Significant improvement of renal function reflected by: glomerular filtration~     rate (GFR), renal blood flow (RBF), excretion of salt and metabolites in the urine and~     related hormones and peptides in the blood. No effect on the systolic function of the heart.~   "
262306|NCT00115921|"~     The purpose of this study is to see if providing effective antimalarial treatment at home for~     parents/guardians to treat their children for malaria will lead to an improved health outcome~     compared to conventional healthcare.~   "
262307|NCT00115908|"~     The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination~     with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C~     genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3~     different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS,~     PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.~   "
262308|NCT00115895|"~     The thyroid cells take up iodine, and radioactive iodine is commonly used to irradiate~     residual thyroid tissue and thyroid cancer following surgical removal of the thyroid gland~     (thyroidectomy). A whole body radioactive iodine scanning is usually carried out after~     thyroidectomy to assess the amount of thyroid tissue left behind at surgery (that might still~     contain cancer), and to evaluate the presence of iodine avid lesions elsewhere in the body~     (that might be cancer metastases). A large dose of radioactive iodine is often given, still~     the optimal iodine dose to ablate the thyroid remnant after surgery is not known. In this~     study, two radioactive iodine doses are compared in the ablation of the thyroid remnant, a~     smaller (1110 MBq) dose and a larger (3700 MBq) dose. The study participants are randomly~     allocated using a 1:1 ratio to receive either the smaller or the larger radioactive iodine~     dose. These treatments are compared for safety, adverse effects, and the need for subsequent~     repeat treatments. The individual absorbed radiation doses are measured. The study hypothesis~     is that fewer repeat radioiodine treatments might be needed after the larger dose, but the~     larger dose might be associated with a higher frequency of adverse events.~   "
262309|NCT00115882|"~     The primary goal of the Hutchinson Study of High School Smoking, a group-randomized trial~     conducted by the Fred Hutchinson Cancer Research Center in partnership with 50 Washington~     State high schools, is to develop and evaluate an innovative proactive smoking cessation~     intervention, based upon Motivational Interviewing (MI) and Cognitive Behavioral Skills~     Training (CBST), for its effectiveness in reaching teen smokers and helping them succeed in~     quitting smoking. A positive finding would have significant implications for reducing youth~     smoking and, ultimately, improving the nation's health.~   "
262310|NCT00115869|"~     The Hutchinson Smoking Prevention Project is a 16-year, group-randomized trial to determine~     the extent to which a school-based (grades 3-10), theory-based, social-influences tobacco use~     prevention intervention can deter youth tobacco use throughout and beyond high school.~   "
262311|NCT00115856|"~     This study aims to develop and refine the use of an intravascular wire to image plaque in the~     aorta, iliac and femoral artery using MRI. This project aims to use this increased resolution~     to identify the features within the plaque that is known to be associated with increased risk~     of plaque and vessel occlusion.~      The hypothesis is Intravascular MRI can detect and measure changes in response to therapy~     over time in the critical features in plaques in peripheral arteries of patients with~     atherosclerosis.~   "
262312|NCT00115843|"~     The purpose of this study is to demonstrate that the use of a continuous ambulatory~     monitoring device will reduce both the time to effective rate control and the health care~     expenditures associated with standard methods of rate control monitoring in patients~     presenting with atrial fibrillation with a rapid heart rate.~   "
262313|NCT00115830|"~     The purpose of the study is to investigate the effects of atorvastatin (Lipitor) and~     rosuvastatin (Crestor), United States Food and Drug Administration (FDA) approved drugs~     commonly prescribed by doctors to lower cholesterol, on certain functions of platelets (cells~     that cause blood clots), white blood cells (cells that are responsible for inflammation), and~     blood flow regulation by arteries. This is important because we are looking at ways to more~     effectively prevent atherosclerosis (plaque buildup in blood vessels) and heart disease. Many~     studies have demonstrated that these drugs are effective at reducing inflammation and~     stabilizing plaques. We are interested in better understanding the effects of these medicines~     on inflammation (pain and swelling) and the mechanism by which they act.~      Hypothesis: Atorvastatin (40mg) will reduce inflammatory markers and activity more than~     Rosuvastatin (10mg) in spite of equal LDL-C reduction.~   "
262314|NCT00115817|"~     The purpose of the study is to evaluate the effects of Atorvastatin.~      The investigators want to find out if atorvastatin has other helpful qualities. The~     investigators are interested in finding out if medicines like atorvastatin are useful even in~     people who do not have high levels of bad cholesterol and would like to understand other~     mechanisms by which this medicine helps prevent further blood vessel disease.~      Hypotheses:~        1. Atorvastatin reduces Rho kinase activity (in leukocytes) rapidly, within days, in~          patients with atherosclerosis.~        2. Any decrease in Rho kinase activity with statin therapy will be accompanied by~          improvement in familiar markers of atherosclerosis.~   "
262315|NCT00115804|"~     The purpose of this research is to conduct an open, pilot trial to assess the efficacy and~     safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).~   "
262316|NCT00115791|"~     The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with~     placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.~   "
262317|NCT00115778|"~     The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent~     bacterial infections in lung transplant patients with low serum levels of immunoglobulin.~   "
262318|NCT00115765|"~     The purpose of this study is to assess whether treatment with the study drug, panitumumab~     given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab~     improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based~     chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or~     irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive~     concomitant panitumumab therapy.~   "
262319|NCT00115752|"~     This study will evaluate how genetic makeup contributes to the variation in people regarding~     their sensitivity to and experience of pain. Scientists believe that differences in~     information found in genes may explain why an analgesic drug, that is, one that treats pain,~     works effectively for some people but not for others. The study will explore pain that is~     acute (fast and short period). Knowledge gained from this ongoing study may permit~     development of an individualized analgesic drug prescription.~      Patients ages 16 to 35 who are in good health and have been referred for removal of impacted~     wisdom teeth; who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs~     (known as NSAIDs), sulfites, or certain anesthetics; who are not pregnant or nursing; and who~     are willing to have a biopsy before and after dental surgery are eligible for this study.~      Patients will come to the clinic for one test visit and one treatment visit. During the first~     visit, a questionnaire will evaluate patients' psychological state, including mood and~     depression. There will be a clinical examination of their wisdom teeth. A blood sample of 10~     milliliters (about 0.4 ounces) will be collected from the forearm to provide DNA material~     containing genes stored in cells. The primary genetic analysis will be done at NIH, although~     the DNA collected might also be sent to a laboratory outside NIH. DNA samples will be coded~     so that names of patients cannot be traced.~      During the second visit, two of the patients' lower wisdom teeth will be removed. Patients~     will be given a local anesthetic in the mouth and a sedative given through a vein in the arm.~     While the mouth is numb, a small piece of tissue will be removed from inside the cheek, near~     the wisdom tooth. It is the first biopsy. After the two wisdom teeth are removed, a small~     piece of tubing will be placed into both sides of the mouth where the teeth were removed.~     Every 20 minutes, for the next 3 hours, the researchers will collect inflammatory fluid from~     the tubing, to measure the chemicals thought to cause pain and swelling. Also every 20~     minutes, patients will rate the pain they feel by answering questions. If there is pain~     before 3 hours following surgery, they will receive a dose of fentanyl to relieve moderate to~     severe pain. A second biopsy will occur 3 hours after surgery, to measure changes in~     chemicals produced in response to surgery. Immediately afterward, patients will receive 30 mg~     of ketorolac (Toradol) whether or not pain is felt. They will answer questionnaires about~     pain for 3 hours after receiving the drug, to rate how well it works. They will stay at the~     clinic up to 6 hours after the surgery. If pain is not relieved with ketorolac, patients will~     receive a one-time dose of tramadol, a pain medication for moderate to severe pain. After the~     study procedures are completed, patients will receive pain medication for pain after surgery.~      Patients will be monitored closely, because all drugs have side effects. Ketorolac is a~     nonsteroidal anti-inflammatory drug, one that may cause gastrointestinal upset. Fentanyl is a~     powerful narcotic drug that is safe at the dosage used in this study, but stomach upset,~     dizziness, and breathing trouble may occur. Also, risks from the biopsy include discomfort~     from injecting the numbing medicine, infection, and bleeding. There may be discomfort from~     the sedative injected into the vein, and there may be bruising.~      Benefits from participating are having wisdom teeth removed at no cost as well as close~     monitoring before and after surgery. There are no plans to give patients the results of~     genetic tests or questionnaires. Years of research may be needed before such information has~     the chance to become meaningful.~   "
262320|NCT00115739|"~     Anaplastic thyroid cancers are rare, aggressive tumors. Standard treatment options include~     surgery and chemoradiation. Few treatment options are available once metastases develop.~     Recent data suggest that Imatinib (Gleevec) may be advantageous in this patient population.~     Patients who have been treated for anaplastic thyroid cancer with chemoradiation or surgery~     who develop recurrent or metastatic disease outside of the field of radiation are eligible.~     Patients will be treated with Imatinib 400 mg two times a day for eight weeks, followed by~     radiologic assessment. Patients will be treated until disease progression or a complete~     response is obtained.~   "
262321|NCT00115726|"~     The purpose of this study is to determine whether continuing or discontinuing furosemide (a~     diuretic) on the day of elective noncardiac surgery for those who take furosemide on a~     chronic basis, causes more intraoperative hypotension (low blood pressure) during surgery.~     Our hypothesis is that the usual practice of continuing furosemide on the day of surgery~     would contribute to more hypotension during surgery than discontinuing furosemide.~   "
262322|NCT00115713|"~     The purpose of this study is to compare the effects of two different types of exercise,~     aerobic exercise training (AET) and resistance exercise training (RET), on quality of life~     (QoL) in early stage breast cancer survivors receiving chemotherapy. It is hypothesized that~     both AET and RET would have beneficial effects on QoL.~   "
262323|NCT00115700|"~     Patients with stage I and II low grade follicular lymphoma are randomised between standard~     therapy (involved field radiotherapy) and investigational therapy (involved field~     radiotherapy and chemotherapy plus rituximab). The main endpoint is progression free survival~     but overall survival and the influence of t(14;18) status will also be studied.~   "
262324|NCT00115687|"~     Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even~     with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely~     exceed 20%. These low quit rates may be due to inadequate treatment of the physical~     dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal~     symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However,~     little information is available on the safety or efficacy of medications to treat pregnant~     smokers.~      The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in~     promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled~     trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6~     week taper) or a matching placebo. Women who are doing well at the end of the trial will also~     be offered gum post-partum for relapse prevention.~   "
262325|NCT00115674|"~     The purpose of this study is to understand the smoking behavior of female incarcerated~     smokers and to determine how smokers differ from non-smokers on measures of substance abuse,~     personality, criminal history, and mental illness~   "
262326|NCT00115661|"~     The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in~     reducing pelvic pain in early stage endometriosis patients.~   "
262327|NCT00115648|"~     The purpose of this study is to determine if extended antiretroviral regimens given to the~     infant during the first 14 weeks of age would decrease breast milk transmission of HIV.~   "
262328|NCT00115635|"~     The aim of the study is to determine the optimal dose of the combination of docetaxel and~     gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with~     respect to efficacy and toxicity in a phase II trial.~   "
262329|NCT00115622|"~     The purpose of the study is to compare the efficacy and safety of an investigational nasal~     spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis.~     Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following~     allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of~     allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly~     referred to as hay fever, it is characterized by sneezing, nasal congestion and pruritus,~     rhinorrhea, and pruritic, watery, red eyes.~   "
262330|NCT00115609|"~     Successful therapy of both tuberculosis and HIV disease share similar problems: pill burden,~     drug interaction, adherence challenge and toxicity. This study will test the efficacy and~     safety of a once daily antiretroviral regimen in HIV-tuberculosis coinfected patients.~   "
262331|NCT00115596|"~     This study is randomized trial of a procedural skills training curriculum utilizing~     simulation to teach basic procedural skills to pediatric residents.~   "
262332|NCT00115583|"~     The purpose of the study is to assess the importance of a substance called endothelin.~     Endothelin is produced by coronary arteries. This study examines this substance to determine~     whether it has an effect on controlling blood flow in coronary arteries. When these arteries~     release too much endothelin, the blood flow to the heart muscle is reduced and this may be~     important in heart conditions. This protocol examines an investigational drug called BQ-123~     to see if it blocks the effect of endothelin. We assess the blood flow in the coronaries and~     evaluate the effects of BQ-123. It is anticipated that this endothelin blocker will open up~     coronary arteries and increase the blood flow to the heart.~   "
262333|NCT00115570|"~     The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and~     effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with~     type 1 diabetes mellitus.~   "
262334|NCT00115557|"~     The major goal of this project is to determine the effectiveness of a multi-component~     intervention designed to help primary care practices implement three office system strategies~     known to increase delivery of immunizations and other preventive services. This two-year~     study will contribute to our understanding of multi-component translational interventions in~     primary care, and particularly within practice-based research networks.~   "
262335|NCT00115544|"~     The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in~     infants who are at risk for an exchange transfusion and meet the criteria of the protocol.~   "
262336|NCT00115531|"~     The purpose of this study is to compare a new higher-dose influenza virus vaccine to the~     standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect~     elderly against viral influenza but not as well as desired. It is expected that the higher~     doses vaccine can be given with little reaction, but this needs to be tested. Up to 410~     people ages 65 years and older will be recruited from the community and from existing~     volunteer populations. Participants will receive either the high or standard dose injected in~     the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory aid~     for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection and~     return to the clinic or contacted by telephone 6 months after the injection.~   "
262337|NCT00115518|"~     The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in~     non-operable NSCLC Stage III (Phase II trial).~      Endpoints:~      safety and feasibility (primary) response, survival, time to progression (secondary)~   "
263473|NCT00100087|"~     The study will investigate the safety and feasibility of using the TheraSight(TM)~     Brachytherapy System for treatment of wet age-related macular degeneration (AMD).~   "
262338|NCT00115505|"~     This research trial studies quality of life, employment, and informal care cost analysis in~     patients with breast cancer receiving chemotherapy. This trial assesses how quality of life~     has been affected by cancer, if cancer and its treatment have caused in changes in the~     patient's or their spouse's employment and how they have affected the patient and their~     extended family, and the impact of peripheral neuropathy caused by chemotherapy on quality of~     life. Learning about quality of life and informal care costs may help doctors better~     understand how patients feel during treatment, what effects the medicines are having, and in~     the future may help both patients and doctors as they decide which medicines to use to treat~     cancer.~   "
262339|NCT00115492|"~     This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary~     Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the~     clinic 10 times. Subjects will be given breathing tests and will record their breathing~     symptoms daily on diary cards. All study related medicines and medical examinations will be~     provided at no cost. The two drugs used in this study have been approved by FDA for use in~     patients with COPD.~   "
262340|NCT00115479|"~     In a previous study, we showed that tight blood glucose control with insulin during intensive~     care reduced morbidity and mortality of surgical intensive care patients. Whether this~     intervention also improves prognosis of medical intensive care patients remains unknown. The~     current prospective, randomized, controlled study will assess the impact of intensive insulin~     therapy on the outcome of patients in a medical intensive care unit. On admission, patients~     will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with~     intensive insulin therapy or the conventional approach, in which insulin infusion is~     initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between~     180 and 200 mg/dl.~   "
262341|NCT00115466|"~     This comparative, multicentre, randomised clinical trial is designed with two parallel groups~     that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem~     Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the~     non-surgical treatment of complex perianal fistula.~   "
262342|NCT00115453|"~     Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique that is~     based on the principle of irradiating boron atoms with neutrons. When neutrons have~     relatively low energy, boron atoms that have been targeted to cancerous tissue using a~     suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will~     capture the neutrons. As a result from the neutron capture the boron atoms will split into~     two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a~     short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect~     mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor.~     In practice, the study participants will receive BPA as an approximately 2-hour intravenous~     infusion, following which the tumor is irradiated with low energy (epithermal) neutrons~     obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose~     planning, but neutron irradiation will last approximately only for one hour. In this study~     BNCT is given only once. The study hypothesis is that glioblastoma tissue may accumulate the~     boron carrier compound, and glioblastoma might respond to BNCT.~   "
262343|NCT00115440|"~     Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which is~     based on the principle of irradiating boron atoms with neutrons. When neutrons have~     relatively low energy, boron atoms that have been targeted to cancerous tissue using a~     suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will~     capture the neutrons. As a result from the neutron capture the boron atoms will split into~     two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a~     short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect~     mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor.~     In practice, the study participants will receive BPA as an approximately 2-hour intravenous~     infusion, following which the tumor is irradiated with low energy (epithermal) neutrons~     obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose~     planning, but neutron irradiation will last approximately only for one hour. In this study~     BNCT is given once. The study hypothesis is that anaplastic astrocytomas and glioblastomas~     that have recurred following conventional radiotherapy might accumulate the boron carrier~     compound, and might respond to BNCT.~   "
262344|NCT00115427|"~     This randomized study was designed to evaluate the efficacy and safety of IPu-infused~     liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic,~     levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period~     followed by implantation of the IPu delivery system and then a 6-month double-blind treatment~     period.~   "
262345|NCT00115414|"~     The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when~     administered on the same day versus the next day of chemotherapy, as measured by the duration~     of grade 4 neutropenia.~   "
262346|NCT00019500|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of raloxifene may be an effective way to prevent~     breast cancer in premenopausal women.~      PURPOSE: Phase II trial to study the effectiveness of raloxifene in preventing invasive~     breast cancer in premenopausal women.~   "
262347|NCT00115401|"~     This study will collect information on the different ways that people walk, that is, their~     gait, when they use ankle braces. Patients will visit NIH on at least three and as many as~     nine separate occasions. A physical therapist will perform a physical examination to~     determine how patients move, how strong they are and what their comfortable walking speed is.~     Then patients will sit on a chair while a camera apparatus takes special pictures of their~     legs, a procedure lasting up to 2 hours. Patients will be asked to return to learn how to~     walk with the custom Passive Dynamic Ankle-Foot Orthosis (PD-AFO)-a unique ankle brace~     designed to improve walking ability by providing natural support to the lower limb.~      Patients 4 and older who are in good health and able to walk repeatedly a distance of 15~     meters (approximately 49 feet) independently and unsupervised may be eligible for this study.~      With this training, patients may return several times to learn how to walk with the brace,~     but for their protection, they will not be allowed to take it or use it outside the research~     team's supervision. The researchers will examine the leg to ensure that the brace fits and~     will ask questions about it. Each training visit will require up to 1.5 hours. When patients~     have learned to walk with the brace, they will be asked to visit again and walk while~     scientific pictures are taken of their legs. During the walking test, patients will wear~     T-shirts and shorts. Patients' arms and legs will be wrapped with a soft, rubber-like~     material, to allow small plastic reflective balls to be attached. Firm material known as a~     shell can be attached to the rubber sleeves, with Velcro or a self-sticking bandage. The~     small balls may also be attached to the skin, with an adhesive. Also, there may be a test of~     the muscles, through the use of electromyography, or EMG. The test involves attachment of~     small metal electrodes to the surface of the skin, again with an adhesive. There should not~     be discomfort with that test.~      As patients walk several times, scientific cameras will record the positions of the~     reflective balls. Pictures do not involve patients' faces or other parts of the body.~     Afterward, a unique chair system called a Biodex will measure the leg muscle strength.~     Patients will be asked to sit on the chair and place their leg in a foot in an apparatus, a~     special structure that measures strength. They will repeatedly push against the apparatus,~     doing so for 3 seconds. Each time patients push, the researchers will touch a small magnetic~     device to the skin, which will cause the muscles to push harder. Although this procedure~     should not cause any discomfort, it may feel unusual. If they wish, patients can ask to stop~     the test at any time. Few risks are involved in participating in this series of activities.~     There is a slight chance of mild skin irritation from the adhesives used on the skin or from~     the soft, rubber-like material. But the material is worn for only a brief period, and skin~     reactions are rare. Also, that material may feel tight, but if it causes discomfort or~     prevents moving, patients can ask a researcher to adjust it. There is a slight chance of skin~     irritation from use of the PD-AFO, but adjustment can be made to make patients comfortable.~     Patients may experience some muscle soreness caused by participating in the muscle strength~     tests. However, they will be safely monitored by a physical therapist when they try on the~     brace to adjust to its feel and fit, as well as during testing of gait.~      This study will not have a direct benefit for participants. However, participants will be~     paid for their time, with minimum compensation of $50.~   "
262348|NCT00115388|"~     Chlamydial infection is a common, sexually transmitted disease which women can have without~     knowing. Untreated, it can lead to an infection of the womb and fallopian tubes called pelvic~     inflammatory disease (PID), which can cause infertility. There has been only one trial of~     chlamydia screening and this was in American women in 1992 and used outdated tests. We now~     need to see if screening using modern tests and self-taken swabs works in a high risk, young,~     multiethnic female population in the United Kingdom (UK).~      The study is a randomised trial. It will involve asking women students in college bars to~     complete confidential questionnaires on sexual health and to provide self-administered~     vaginal swabs. We have successfully done this in a small pilot study. Participants will be~     told that the tests are for research purposes only and that if they think they may have been~     at risk of a sexually transmitted infection they should get checked at a clinic. If the trial~     shows that chlamydia screening using these new methods prevents PID, extending this~     community-based intervention nationwide could improve women's reproductive health and~     wellbeing and might prevent some women from becoming infertile~   "
262351|NCT00115349|"~     The purpose of this study is to determine whether left ventricular function improves more~     rapidly with deferoxamine (DFO) and deferiprone (L1) combination therapy than with DFO~     monotherapy in patients with thalassemia and decreased ejection fractions. Secondary aims~     include evaluating changes in myocardial iron burden using T2* and estimating the relative~     incidence and severity of chelator-induced toxicity.~   "
262352|NCT00115336|"~     The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory~     drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis~     of sickle cell disease (SCD).~   "
262353|NCT00115323|"~     This is a randomized, controlled study that will compare two medication adherence strategies~     in adults with moderate or severe persistent asthma as a method for improving or maintaining~     treatment adherence.~   "
262354|NCT00115310|"~     The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 60~     minutes for the treatment of postherpetic neuralgia (PHN).~   "
262355|NCT00115297|"~     This study will determine the effects of montelukast on the duration of wheezing in children~     12 months to 3 years of age who visit a physician for care of a wheezing illness. Only~     patients from the Ankara area of Hacettepe University Medical Center in Turkey will be~     included in this study.~   "
262356|NCT00115284|"~     The purpose of this study is to determine whether having physicians evaluate their management~     of certain diseases as part of board recertification results in improved patient care.~   "
262357|NCT00115271|"~     The purpose of this study was to determine the effects of providing supplements containing~     alternative combinations of micronutrients during pregnancy on birth weight and other infant~     and maternal health and nutritional outcomes in a rural area of Nepal.~   "
262358|NCT00115258|"~     The purpose of this study is to determine which method of providing parenteral nutrition~     (complete intravenous nutrition) will provide the best nutritional and clinical results to~     children undergoing hematopoietic stem cell transplantation.~   "
262359|NCT00115245|"~     This research study is being conducted to compare the safety and effectiveness of the~     investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by~     the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The~     results for patients taking LdT will be compared to results for patients taking adefovir~     dipivoxil.~   "
262360|NCT00115232|"~     The purpose of this study is to evaluate levels of inflammatory mediators in children at risk~     for cardiovascular disease due to family history. We are measuring inflammatory markers in~     two groups of children and their parents: children with a family history of early~     atherosclerotic heart disease (cases), and healthy children without such a family history~     (controls). The design is a cross-sectional study, gathering a fasting blood sample and~     clinical and behavioral data on children and a parent.~   "
262361|NCT00115219|"~     The purpose of this study objective will be to evaluate the efficacy and safety of etanercept~     50 mg BIW in RA subjects who showed a sub-optimal response to standard dose etanercept (50 mg~     QW) and concomitant methotrexate therapy.~   "
262362|NCT00115206|"~     The purpose of this study is to estimate the relationship between patient reported outcomes~     (PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with~     or without Neulasta® (pegfilgrastim).~   "
262363|NCT00115193|"~     The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when~     administered on the same day versus the next day of chemotherapy, as measured by the duration~     of grade 4 neutropenia.~   "
262364|NCT00115180|"~     We aim to compare pain management among three groups of ethnic disparity (ED) patients,~     Hispanics, non-Hispanic Blacks, non-Hispanic Whites, and assess whether the observed~     association between pain management and race/ethnicity is independent of potentially~     important confounding variables (e.g., age, sex, insurance status, education). We also aim to~     assess whether the effect of race/ethnicity on adequacy of pain management is explained by~     patients' initial pain intensity or by discordance between patient and physician's: a)~     race/ethnicity; b) perception of patient's pain. To do this 285 patients with long-bone~     fractures will be recruited in the EDs of one municipal and one voluntary hospital serving an~     inner-city, disadvantaged population in the Bronx. Data will be collected on pain using~     self-reported pain and non-verbal pain expressions at baseline, one hour post-baseline, and~     discharge. Data on analgesics administered, patient and physician characteristics will also~     be collected.~      We plan to conduct a chart review of long bone fractures in 2000 and 2001 so that we can~     analyze the association between race/ethnicity and pain management using the same design as~     published studies. Comparison of the retrospective and prospective studies will strengthen~     inferences that can be drawn.~      We hypothesize that Black and Hispanic patients will be less likely to receive opioid~     analgesics than white patients.~   "
262365|NCT00115167|"~     The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of~     treatment in subjects with anemia of cancer who are not receiving chemotherapy.~   "
262366|NCT00115154|"~     The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream~     compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand~     when the cream is applied once daily 2 days per week for 16 weeks.~   "
262367|NCT00115141|"~     The primary purpose of this study is to evaluate the effectiveness in adults, of four~     different strengths of resiquimod gel applied to common wart(s) three times a week for four~     weeks.~      A second purpose is to evaluate the safety of the drug.~   "
262368|NCT00115128|"~     The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by~     filgrastim in normal donors.~   "
262369|NCT00115115|"~     Donor pre-treatment with dopamine reduces injury to the kidney graft with consequences on the~     clinical performance immediately after transplantation: Donor dopamine reduces the~     requirement of dialysis post transplant, and results in renal function improvements.~      The purpose of the study is to investigate the potentially therapeutic impact of donor~     preconditioning with low dose dopamine in human renal transplant recipients from a brain dead~     donor.~   "
262424|NCT00114387|"~     The purpose of this study is to examine whether vitamin E (DL-alpha-tocopherol)~     supplementation will reduce the progression of early atherosclerosis in healthy individuals~     over 40 years of age with low-density lipoprotein (LDL) cholesterol levels greater than or~     equal to 130mg/dL.~   "
262370|NCT00115102|"~     This project examines experimental pain and chronic pain in the mouth, specifically the~     condition called atypical odontalgia (AO:atypical toothpain). In 16 patients with AO and 16~     healthy persons, capsaicin (chili-pepper) is applied to the gingiva to cause pain. This pain~     is evaluated by the participants. In three sessions, 3 different medications are tested for~     effect on the pain. The medications are fentanyl, S-ketamine and placebo-treatment (saline).~     The aim is to know more about pain mechanisms in AO in order to develop an effective~     treatment.~   "
262371|NCT00115089|"~     This is a study of the effectiveness and safety of a new nasal spray for the relief of the~     symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy~     medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid~     treatment), and an inactive placebo. The study hypothesis is that R926112 will be superior to~     placebo at the end of a week of testing and evaluation. The study does not have the power to~     determine how R926112 compares to Beconase.~   "
262372|NCT00115076|"~     Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is~     to study the action and the effects of Efalizumab, on psoriasis. This medication has been~     studied extensively and has been found to be effective and safe in the treatment of~     psoriasis. The eligible patient will have 10% of his/her body surface area involved with~     psoriasis vulgaris.~   "
262373|NCT00115063|"~     LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for~     individuals with extreme obesity (body mass index [BMI] 40-60 kg/m2). The intensive medical~     treatment is designed to produce 25% weight loss from baseline and to maintain at least 20%~     weight loss from baseline. The intensive medical treatment is compared to a usual care~     treatment model where individuals utilize self directed approaches to weight loss. The active~     treatment period is three years, followed by two years of observation.~   "
262374|NCT00115050|"~     This is an open-label safety study to provide early access to TMC114 for HIV-1 infected~     patients who have failed and exhausted regimens based on commercially available~     antiretroviral (ARV) therapy and who are ineligible for participation in any other~     Tibotec-sponsored trial.~   "
262375|NCT00115037|"~     This is a study involving treatment for alcohol dependence (alcoholism). The study will~     combine motivational enhancement therapy and cognitive behavioral therapy (combined~     behavioral intervention, or CBI) and tests the benefits of continued/discontinued treatment~     with naltrexone in a randomized placebo-controlled trial. CBI may have advantages in~     motivating patients to greater medication adherence and may address psychosocial factors that~     may limit the effects of naltrexone.~   "
262376|NCT00115024|"~     The purpose of this study is to determine the effects of estrogen replacement therapy (ERT)~     on the progression of early atherosclerosis in healthy postmenopausal women without~     preexisting cardiovascular disease (CVD).~   "
262377|NCT00115011|"~     The purpose of this study is to determine the effectiveness of escitalopram in treating~     self-injurious skin picking.~   "
262378|NCT00114998|"~     To study cardiac and vascular structure and function in a population of adolescents with type~     2 diabetes mellitus (T2DM) compared to a similar group with obesity alone and a similar~     non-obese group.~   "
262379|NCT00114985|"~     During 3D-conformal external beam radiation therapy treatments for prostate cancer, the~     prostate gland moves. The purpose of this study is to determine whether the placement of a~     prostate immobilization device into the rectum during radiation treatments will decrease the~     risk of rectal bleeding that is sometimes seen as a late effect from radiation.~   "
262380|NCT00114972|"~     The SYNTAX trial is designed to determine the best treatment for patients with complex~     coronary disease (blocked or narrowed arteries in both the right and left sides of the heart)~     by randomizing patients to receive either percutaneous coronary intervention (PCI) with~     polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).~   "
262381|NCT00114959|"~     This will be an open label, multi-center study of up to 77 patients with CML in chronic,~     accelerated or blast phase who have developed resistance to or have failed previous treatment~     with Gleevec (imatinib mesylate). Because these patients may still be sensitive to Gleevec,~     adding Homoharringtonine may restore a response to Gleevec or the combined treatment may~     promote a better response than using Gleevec alone.~   "
262382|NCT00114946|"~     This is a randomized, open-label, active-control, multicenter trial comparing two~     oxaliplatin/Avastin-based treatment sequences as first-line therapy for metastatic colorectal~     cancer. The study is designed to compare the efficacy of these two treatment sequences with~     respect to progression free survival (PFS) and overall survival.~   "
262383|NCT00114933|"~     Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been~     undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir~     pharmacokinetics might prevent resistance development in patients who experience virological~     rebound after single-drug simplification.~   "
262384|NCT00114920|"~     The primary purpose of this study is to evaluate the effectiveness in adults, of four~     different strengths of resiquimod gel applied to common wart(s) three times a week for twelve~     weeks.~      A second purpose is to evaluate the safety of the drug.~   "
262385|NCT00114907|"~     It is proposed to investigate the association between consumption of black tea and various~     selective fasting blood serum and urine biomarkers in a Mauritian population with ischaemic~     heart diseases. This study, the first of its kind, will provide clinical data on the~     potential prophylactic propensities of Mauritian black tea against cardiovascular disease,~     which remains one of the major health threats to the Mauritian population.~   "
262386|NCT00114894|"~     Jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150~     million envenomations annually. Fatalities and hospitalizations occur annually, particularly~     in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous~     coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. The field~     effectiveness is unknown. This is a field test to determine the real world effectiveness.~   "
262421|NCT00114426|"~     In this proposal, we will implement a randomized controlled trial to determine whether~     nocturnal NIMV applied for 3 months: 1) improves (disease-specific) health related quality of~     life (HRQL) of COPD patients compared to a control group of patients treated with sham NIMV~     therapy (primary outcome); 2) improves exercise tolerance and walking capacity of COPD~     patients; and 3) improves heart rate variability and decreases sympathetic tone in COPD.~   "
262387|NCT00114881|"~     The purpose of this study is to determine the way environmental factors (like the components~     of inner-city household dust) affect immune system development and symptoms of asthma in~     inner city children. The study is divided into three periods, as the subjects age from birth~     to 10 years old. Each age bracket will explore different objectives and endpoints.~      Study Objectives/Hypotheses:~        1. Subjects age 0 to 3 years old:~             -  Environmental factors in the inner city adversely influence the development of the~               immune system to promote cytokine dysregulation, allergy, and recurrent wheezing by~               age 3.~             -  Children who have had a viral lower respiratory infection and have developed~               cytokine dysregulation by age 3 are at increased risk for the development of asthma~               by age 6.~        2. Subjects age 4 to 7 years old:~             -  There is a unique pattern of immune development that is driven by specific urban~               exposures in early life, and this pattern of immune development is characterized~               by: 1) impairment of antiviral responses and 2) accentuation of Th2-like responses~               (e.g. cockroach-specific Interleukin-13(IL-13)). The clinical effects of these~               changes in immune development are frequent virus-induced wheezing and allergic~               sensitization by 3-4 years of age, and these characteristics synergistically~               increase the risk of asthma at age 7 years.~        3. Subjects age 7 to 10 years old:~             -  There are unique combinations of environmental exposures (cockroach allergens,~               indoor pollutants [Environmental Tobacco Smoke (ETS) and Nitrogen Dioxide (NO2)],~               lack of microbial exposure), and family characteristics (stress, genetic factors~               related to innate immunity) that synergistically promote asthma onset, persistence,~               and morbidity in urban neighborhoods. These exposures and characteristics influence~               immune expression and lung development during critical periods of growth, resulting~               in specific asthma phenotypes.~        4. Subjects age 10 to 16 years old:~             -  To determine the wheezing, asthma and atopy phenotypes in minority children growing~               up in poor urban neighborhoods as they develop from birth through adolescence.~   "
262388|NCT00114868|"~     This study was a randomized, community-based trial testing whether dosing newborn infants in~     the first few days after delivery with a large dose of vitamin A could reduce early infant~     morbidity, mortality and improve growth. Pregnant women in 2 districts of Tamil Nadu State in~     southern India were identified and recruited for participation. When the child was born,~     study staff were notified and traveled to the house to collect information and provide the~     vitamin A or placebo dose. Children were visited every two weeks until they were 6 months of~     age to collect information about vital status and morbidity. All children were discharged~     from the study at 6 months after growth was assessed and they received a 100,000 IU dose of~     vitamin A.~   "
262389|NCT00114855|"~     The purpose of this study is to determine to what degree Hypocol® (Red Yeast Rice) may lower~     low density lipoprotein (LDL)-cholesterol in a European population. The effect of Red Yeast~     Rice on fasting blood glucose and inflammatory markers will also be investigated.~   "
262390|NCT00114842|"~     The purpose of this study is to determine if MR colonography with fecal tagging is better~     using air or water for distension of the colon. Patients referred to colonoscopy are offered~     MR colonography before colonoscopy. Two days before colonography, patients ingest a 200 ml~     Barium sulfate solution 2% four times a day, which will render fecal masses invisible on~     the following MR colonography. Air or water (randomised trial) is used for distension of the~     colon. The examinations are evaluated by two independent blinded readers.~   "
262391|NCT00114829|"~     The purpose of this study is to determine whether a colonic tumor can be classified as~     malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon~     carcinoma or benign tumor based on diverticulitis are offered a MR colonography with~     intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the~     dynamic contrast uptake and morphology. The Investigator is blinded from the verified~     diagnosis and the MR classification is compared to the histological diagnosis.~   "
262392|NCT00114816|"~     This study compares two chemotherapy regimens as adjuvant treatment for breast cancer. The~     study participants are randomly allocated to receive either 3 cycles of docetaxel followed by~     3 cycles of CEF (cyclophosphamide, epirubicin and 5-fluorouracil) or to receive 3 cycles of~     docetaxel plus capecitabine followed by 3 cycles of CEX (cyclophosphamide, epirubicin and~     capecitabine). The study participants are required to to have a medium to high risk for~     breast cancer recurrence. The primary aim of the study is to investigate whether addition of~     capecitabine to a standard taxane/anthracycline regimen will influence recurrence-free~     survival.~   "
262393|NCT00114803|"~     The hypothesis underlying this study is that nasally administered calcitonin will stabilize~     or improve bone mineral density in young patients with ulcerative colitis or Crohn's disease.~     Patients who participate will receive either calcitonin or placebo and will have their bone~     mineral density measured at the start, at nine months, and at 18 months of study.~     Participants will also receive age appropriate doses of vitamin D and calcium supplements.~     Other serological measures of vitamin D status will be obtained every 3 months during the~     study.~   "
262394|NCT00114790|"~     Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which is~     based on the principle of irradiating boron atoms with neutrons. When neutrons have~     relatively low energy, boron atoms that have been targeted to cancerous tissue using a~     suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will~     capture the neutrons. As a result from the neutron capture the boron atoms will split into~     two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a~     short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect~     mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor.~     In practice, the study participants will receive BPA as an approximately 2-hour intravenous~     infusion, following which the tumor is irradiated with low energy (epithermal) neutrons~     obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose~     planning, but neutron irradiation will last approximately only for one hour. In this study~     BNCT will be repeated, and the 2 treatments will be given 3 to 5 weeks apart. The study~     hypothesis is that head and neck cancers that have recurred following conventional~     radiotherapy might accumulate the boron carrier compound, and might respond to BNCT.~   "
262395|NCT00114777|"~     The purpose of this trial is to learn if Belatacept is effective and safe as a first line of~     immunosuppression treatment in patients undergoing a renal transplant where the donor kidney~     is obtained in patients with extended criteria.~   "
262396|NCT00114764|"~     The purpose of this study is to determine if a single dose of pegfilgrastim is able to reduce~     the time of severe neutropenia in patients receiving induction and consolidation~     myelosuppressive chemotherapy for de novo acute myeloid leukemia similar to filgrastim.~   "
262397|NCT00114738|"~     This study will evaluate the effectiveness of EPOCH-R chemotherapy plus bortezomib for~     treating mantle cell lymphoma, a cancer of white blood cells called lymphocytes. EPOCH-R~     consists of the drugs prednisone, etoposide, doxorubicin and vincristine, with the addition~     of a new drug called rituximab. In a recent study of patients with newly diagnosed mantle~     cell lymphoma, 92 percent had a complete remission of their disease after treatment with~     EPOCH-R. This study will test whether adding bortezomib as maintenance therapy once~     chemotherapy is finished will lengthen the time before the disease relapses and improve the~     overall cure rate.~      Patients 18 years of age and older with mantle cell lymphoma may be eligible for this study.~     Candidates are screened with a medical history and physical examination, blood and urine~     tests, electrocardiogram, MUGA or echocardiogram, imaging studies and biopsy to determine the~     extent of disease, and possible colonoscopy.~      Participants undergo treatment in three parts, as follows:~        -  Part 1: Bortezomib alone: Patients receive 4 doses of bortezomib over 3 weeks. The drug~          is injected into a vein over about 30 seconds.~        -  Part 2: EPOCH-R chemotherapy plus bortezomib: This phase of treatment begins 3 to 4~          weeks after completing Part 1. Treatment is given on an outpatient basis in six 3-week~          cycles, with all drugs administered over the first 5 days of each cycle. Patients take~          prednisone by mouth on days 1 to 5 and etoposide, doxorubicin, and vincristine as a~          96-hour infusion through a vein over days 1 to 5. The infused drugs are delivered~          through a lightweight, portable infusion pump. Rituximab is given by vein over several~          hours on day 1 immediately before the chemotherapy infusion begins. Bortezomib is given~          by vein over 30 seconds on day 1 before the rituximab and again on day 4.~          Cyclophosphamide is given by vein over about 15 minutes on day 5 immediately after the~          chemotherapy infusion is completed. Patients are taught how to self inject G-CSF, a drug~          that helps boost white cell counts after chemotherapy. They inject the drug under the~          skin (like an insulin shot) for 10 days of each cycle beginning day 6. Patients also~          take an antibiotic to help prevent infection during chemotherapy.~        -  Part 3: Bortezomib alone: After completing EPOCH-R-B therapy, patients are randomly~          assigned to receive or not to receive bortezomib alone. The drug is given in 2 doses~          over 5 days, with a break of 16 days before the next dose. These 3-week cycles continue~          for up to 18 months or until the disease comes back or worsens. Patients who are~          assigned to the group that does not receive bortezomib will be offered the drug if their~          disease relapses.~      During therapy, patients have tests performed on their bone marrow, tumor tissue, blood or~     other fluids to look at different genes and proteins that may be involved in the development~     of their lymphoma or the reaction of the immune system. A tissue biopsy is done before~     treatment begins and a day after treatment starts. Disease progress is followed with CT scans~     and blood tests. When treatment is completed, patients whose cancer has disappeared are~     scheduled for periodic follow-up examinations and tests. Those whose disease remains or~     recurs may be offered participation in another protocol if an appropriate one is available or~     are returned to the care of their local physician.~   "
262422|NCT00114413|"~     The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures~     exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating~     asthma symptoms when combined with existing asthma treatment guidelines than treatment using~     the guidelines alone.~   "
263474|NCT00100074|"~     To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.~   "
262398|NCT00114725|"~     Laser-assisted intracytoplasmic sperm injection (ICSI) has been suggested as a more effective~     alterative to conventional ICSI when this method of insemination is indicated for patients~     undergoing in vitro fertilization (IVF). Laser-assisted ICSI differs from conventional ICSI~     in that a laser is used to drill a small hole through the hard outer coating surrounding an~     egg before the injection needle containing a single sperm is inserted into the egg. The hole~     eliminates compression of the egg that normally occurs with conventional ICSI, and thus may~     reduce the chance of damage. Laser-assisted ICSI is hypothesized to result in increased egg~     survival, and perhaps improved embryo quality, compared to conventional ICSI.~   "
262399|NCT00114712|"~     Ribavirin should be avoided during pregnancy and during the 6 months before pregnancy in both~     the female and the male sexual partner. If a pregnancy occurs and is reported to the~     Ribavirin Pregnancy Registry, the Registry will follow the pregnant woman throughout~     pregnancy. The Registry will also follow the infant until 1 year of age. The goal of the~     Registry is to learn more about the effects of ribavirin on pregnancy and the risk for birth~     defects. Pregnant women exposed to ribavirin, either by taking ribavirin (during pregnancy or~     6 months before pregnancy) or through a male sexual partner (who took ribavirin during the~     female partner's pregnancy or during the 6 months before pregnancy), are encouraged to~     contact the Registry.~   "
262400|NCT00114699|"~     This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in~     HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy.~     Subjects will be randomly assigned to receive a single intravenous (IV) infusion of one of~     four dose levels of CCR5mAb004 or matching placebo. A minimum of 10 subjects will be~     randomized to each cohort at a ratio of 4:1 (active:placebo). A minimum of 40 and maximum of~     60 subjects will be enrolled. This study will be conducted at up to 10 sites in the United~     States.~      Subjects in each cohort will be followed for 56 days after study agent administration. The~     safety, tolerability, and immunogenicity of CCR5mAb004 will be evaluated based on physical~     examination, adverse event (AE) reporting, and clinical laboratory tests. Blood will be~     collected at specified times for the determination of CCR5mAb004 serum concentrations, HIV-1~     RNA levels, and CD4+ and CD8+ cell counts. If CD4+ cell counts are less than 200 during the~     study period, the subject should be offered standard-of-care per HIV treatment guidelines~     that may include the initiation of appropriate anti-retroviral therapy (AVR). CCR5mAb004~     pharmacokinetic (PK) and pharmacodynamics (PD) will be measured over the 56-day study period.~     Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and~     Day 56.~   "
262401|NCT00114686|"~     The purpose of this study is to determine whether treatment with Quetiapine Fumarate~     (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps~     patients who have Bipolar I Disorder with Alcohol Dependence~   "
262402|NCT00114673|"~     Skin chronically exposed to the sun may become damaged and then develop wrinkles and/or~     uneven skin color. The purpose of this research study is to evaluate a newly developed scale~     (grading tool) that rates wrinkles and uneven skin color. This newly developed scale will be~     used in future topical drug studies to measure these changes in the skin.~   "
262403|NCT00114660|"~     This study will check to see if using cocoa butter lotion on the belly, breasts and thighs~     will help reduce the appearance of stretch marks in pregnancy. Women entering the study will~     either receive a lotion containing cocoa butter with vitamin E or a lotion containing only~     vitamin E. After delivery, the study investigators will evaluate whether the women who used~     cocoa butter lotion were less likely to develop stretch marks.~   "
262404|NCT00114647|"~     This study will collect blood plasma and white blood cells from individuals using a procedure~     called apheresis. Apheresis is a method of collecting larger quantities of certain blood~     components that can safely be collected through a simple blood draw. The blood components~     will be used in laboratory research studies.~      Patients 18 years of age and older who are currently enrolled in a NIH clinical research~     protocol may participate in this study. Relatives of patients and normal healthy volunteers~     will also be enrolled.~      Individuals will undergo one of the following two apheresis procedures:~        -  Automated pheresis Blood is drawn through a needle placed in an arm vein and circulated~          through a cell separator machine. The plasma (liquid part of the blood) and white cells~          are extracted, and the red cells are re-infused into the donor through the same needle~          or a needle in the other arm. An anticoagulant (medication to prevent blood from~          clotting) is usually added to the blood while in the machine to prevent it from clotting~          during processing.~        -  Manual pheresis One unit (1 pint) of blood is drawn through a needle placed in an arm~          vein, similar to donating a pint of whole blood. The red blood cells, with or without~          plasma, are separated from the rest of the blood and returned to the donor through the~          same needle. Manual pheresis will be done only when a person s estimated total blood~          volume or red cell count is too low to safely permit removal of blood through a pheresis~          machine. An adult small in size or markedly anemic, for example, may fall into this~          category.~      Some of the blood collected through apheresis may be stored for future studies of HIV disease~     and immune function and for HLA testing, a genetic test of markers of the immune system. Some~     of the blood may be used to screen for different types of viral liver infections, such as~     hepatitis A, B, C, D, E, F, or G.~   "
262405|NCT00114634|"~     This 10-week study will evaluate and compare behavior changes in children with~     Smith-Lemli-Opitz syndrome (SLOS) who are taking cholesterol supplementation versus those who~     are not on cholesterol supplementation. SLOS is a genetic disorder that affects the~     development of children both before and after birth. An enzyme deficiency in these children~     results in low levels of cholesterol, which can cause a variety of birth defects and~     behavioral problems. Typical abnormal physical features of patients include a small head,~     drooping eyelids, small upturned nose, small chin, cleft palate, heart defects, and extra~     fingers or toes.~      Children between 5 and 17 with mild SLOS who do not have a history of egg allergy or~     intolerance may be eligible for this study. Candidates are screened with a questionnaire~     about the patient's age, genotype (if known), sterol levels, symptoms, current treatment and~     medical history.~      Children participate in two 2-week study phases. Between the study phases the children will~     take 150 mg/kg daily of a cholesterol preparation typically used to supplement cholesterol in~     patients in SLOS studies at NIH. In the study phases, the participants are randomly assigned~     to take either egg yolk or an egg yolk substitute, such as Egg Beaters, that does not contain~     cholesterol. The study is done at the participant's home, and the cholesterol supplementation~     and egg/egg substitute are sent to the home each day with instructions on how to take them.~      The caretakers can stop the study phases after four days if behavior problems occur.~      The children's caretakers fill out a standard behavioral questionnaire, the Aberrant Behavior~     Checklist. The questionnaire is designed to assess the effects of treatment in mentally~     impaired persons.~   "
262406|NCT00114621|"~     This study will examine the recombinant, that is, produced by genetic engineering, protective~     antigen (rPA) that brings about antibodies to neutralize the anthrax toxin and that could~     therefore be predicted to offer protection against anthrax. Today, anthrax is rarely~     encountered in the United States, since the introduction of vaccines for cattle in the 1930s.~     A human vaccine was licensed in 1970. Vaccination against anthrax has been confined to people~     at risk, such as wool sorters and some veterinarians. However, the rising prospects of B.~     anthracis being used as a weapon have led to routine administration of the anthrax vaccine to~     members of the armed forces.~      Adults who are in good health may be eligible for this study. The involvement of 300 adults~     is planned.~      Participants will have a general physical exam and test for vital signs. There will also be~     collection of blood for chemistry and hematology; urinalysis; tests for HIV, hepatitis B and~     C, and liver function; and a pregnancy test, if applicable.~      On a random basis, patients will receive one of the rPA formulations. Two doses of rPA will~     be evaluated, 10 microgram ((Micro)g) and 20 (Micro)g. This evaluation aims to establish the~     safety and most desirable level of dosage. Patients will receive one injection of the~     vaccine, administered in the left shoulder or left thigh. About 30 minutes later, their~     temperature will be taken, and the injection site will be inspected. Rare but severe~     reactions could occur if there is extreme sensitivity to a vaccine. However, such an~     occurrence is extremely rare following a vaccine, and if there are any dangerous symptoms,~     they can be effectively treated by medications available to patients while they are at the~     clinic. If there are no significant abnormal results, patients may return home. About 6 hours~     later and daily for 7 days, they will take their temperature and examine the injection site.~     The vaccine may cause temporary discomfort at the site of injection, and participants may~     experience a mild fever for 1 or 2 days after vaccination.~      Patients will receive diary cards, a digital thermometer, and instructions on taking their~     temperature and measuring redness and swelling at the injection site, as well as for~     recording aches, muscle pain, or sensitivity to light for 7 days. They will be examined at~     the clinic at 72 hours following vaccination and also on the 7th day if they have a fever at~     or above 100.4 , if swelling is at or more than 2 inches, or if they request an exam.~     Meanwhile, a clinic staff member will call patients and discuss the findings. Then patients~     will receive a second and third injection of the same vaccine at 2-month intervals. There~     will also be interviews about patients' health at each visit to the clinic, plus monitoring~     of the vaccination after 6 hours and for 7 days. One year later, patients will receive a~     fourth injection of the same vaccine.~      Direct benefit to participants in this study is not guaranteed, although an antibody response~     is predicted. The results in this study will help in the development of improved vaccines for~     anthrax.~   "
263014|NCT00106327|"~     The purpose of this study is to compare the effects of nutrition, a supervised treadmill~     exercise program, and supervised progressive resistance training program on peripheral~     arterial disease.~   "
262407|NCT00114608|"~     Electrical stimulation of the foot can increase blood flow out of the leg. This increased~     blood flow can prevent blood clots from forming in the leg veins.~      Blood clots in the leg veins can break off and form life-threatening blood clots in the~     lungs.~      Intermittent external pneumatic (air) compression of the foot is already used to increase~     blood flow in at risk patients.~      Hypothesis: Electrical stimulation of the foot increases blood flow out of the legs to the~     same degree as intermittent external pneumatic (air) compression of the foot.~   "
262408|NCT00114595|"~     Tardive dyskinesia is a common complication of conventional antipsychotic treatment in~     subjects with schizophrenia. This study investigates whether the addition of the omega-3~     fatty acid, ethyl-eicosapentaenoic acid (EPA) to usual treatment improves movement disorder~     in 84 schizophrenia subjects with established tardive dyskinesia. The initial double-blinded,~     randomised trial duration is 12 weeks, followed by further 46 weeks of open-label treatment.~   "
262409|NCT00114582|"~     Optimizing the social and physical ambiance during mealtimes in Dutch nursing homes:~     implementation and evaluation of the effect with respect to quality of life, nutritional~     status and physical performance.~   "
262410|NCT00114569|"~     The purpose of this study is to gather the data to: 1) determine the best dose, and 2)~     evaluate its effectiveness and safety in stopping seizures. Part 1 is a pharmacokinetic study~     (study of how much drug is found in the body after it is given through a vein and how fast~     the body gets rid of the drug).~   "
262411|NCT00114556|"~     Following liver transplantation, rapid bone loss occurs, particularly within the first 6~     months post-transplant. This may be associated with fractures, most notable vertebral. The~     ability to assess osteoporosis therapies in this system may provide useful information for~     osteoporosis management in general.~      Hypotheses:~        1. That treatment with the bisphosphonate, zoledronate, at the time of liver~          transplantation and at 1 month post-transplantation will prevent the early~          transplant-related bone loss (measured by bone densitometry and biochemical bone markers~          at 3 months) seen in patients who are not treated with a bisphosphonate~        2. That continuing treatment with zoledronate at 3 monthly intervals for a total duration~          of 12 months will result in further improvements in bone density beyond that seen at 3~          months~        3. That calcium and vitamin D (vit D) supplementation of liver transplant patients does not~          prevent marked bone loss following transplantation.~   "
262412|NCT00114543|"~     This multi-center, randomized clinical trial compared different bilirubin levels as~     thresholds for timing of phototherapy in extremely low birth weight infants. The primary~     hypothesis was that there would be no difference in death or neurodevelopmental impairment at~     18-22 months corrected age in infants treated by either aggressive or conservative threshold~     limits. 1,978 infants were enrolled.~   "
262413|NCT00114530|"~     SCOT is a clinical research study designed for people with severe forms of scleroderma. SCOT~     stands for Scleroderma: Cyclophosphamide Or Transplantation. The SCOT study will compare the~     potential benefits of stem cell transplant and high-dose monthly cyclophosphamide (Cytoxan)~     in the treatment of scleroderma.~   "
262414|NCT00114517|"~     The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the~     progression of early (subclinical) atherosclerosis and cognitive decline in healthy~     postmenopausal women.~   "
262415|NCT00114504|"~     The purpose of this study is to determine whether FDG-PET is capable of detecting~     atherosclerotic plaque inflammation and monitoring the effects of statins on plaque~     inflammation. The usefulness of FDG-PET in risk stratification is also investigated.~   "
262416|NCT00114491|"~     Recent studies support the hypothesis that aortic stenosis (AS) develops due to~     atherosclerosis affecting the aortic valve endothelium. The study’s aim was to assess~     Rosuvastatin on the hemodynamic progression and inflammatory markers of AS by treating~     low-density lipoprotein (LDL) in patients with AS according to the National Cholesterol~     Education Program Adult Treatment Panel III (NCEP-ATPIII) guidelines for one year.~   "
262417|NCT00114478|"~     The purpose of this study is to see which of the two most common drugs used to treat~     bronchiolitis works better. A child's participation in this study is expected to last less~     than 4 hours. Approximately 600 patients will be recruited to participate in this study at~     Kern Medical Center (KMC).~      Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat~     this disease but nobody knows which one, if any, works the best. Two of the most commonly~     used drugs are albuterol and epinephrine. These are both drugs given during breathing~     treatments with oxygen and a mask. We are doing this study to see which of these drugs works~     better or if they are both equally good. The study works as follows: after the consent~     process the baby gets three treatments.~        -  Nebulizer 1 (Treatment)~        -  Treatment + 30 minutes (approximately) Nebulizer 2~        -  Treatment + 60 minutes (approximately) Nebulizer 3~        -  Treatment + 120 minutes (approximately)~      The baby will be reevaluated and either discharged home or revert to standard therapy. If the~     baby is discharged directly from the emergency department (E.D.), we will call you in three~     days time to see how he/she is doing.~   "
262418|NCT00114465|"~     The primary objective of the study is to compare the efficacy of the probiotic VSL#3 versus~     placebo, in addition to standard maintenance drugs, in maintaining remission in Crohn's~     disease (CD).~      The secondary objectives are:~        -  To determine the time till flare of CD patients on VSL#3 compared to placebo.~        -  To assess whether concurrent therapy with VSL#3 leads to an improvement in the quality~          of life (QOL).~        -  To assess whether concurrent therapy with VSL#3 reduces the severity of a flare if it~          occurs.~   "
262419|NCT00114452|"~     The purpose of the study is to determine whether adult stem cells [Provacel™(PUMP1)] are safe~     and possibly effective in the treatment of acute myocardial infarction (heart attack).~   "
262420|NCT00114439|"~     This trial will examine the efficacy of lithium in providing symptomatic relief from the~     withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular~     use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can~     be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from~     such symptoms may be important in helping some clients achieve a period of abstinence and~     facilitate subsequent entry into a relapse prevention program.~   "
263015|NCT00106314|"~     The purpose of this study is to evaluate the efficacy and safety of Inflabloc Cap~     (Dehydroepiandrosterone [DHEA]) in the treatment of patients with moderately active Crohn's~     disease.~   "
262425|NCT00114374|"~     The purpose of this study is to examine the efficacy of escitalopram compared to placebo in~     reducing Acute Stress Disorder (ASD) symptoms and in preventing the emergence of~     Post-Traumatic Stress Disorder (PTSD) in patients with medical trauma who are at risk for the~     development of PTSD based on the presence of ASD symptoms.~   "
262426|NCT00114361|"~     The purpose of this study is to investigate whether in patients with chronic HBeAg-negative~     hepatitis B, PEG-IFN-ribavirin combination therapy for 1 year leads to enhanced response (HBV~     DNA <10E4 copies/ml and normal ALT 24 weeks after treatment discontinuation) in comparison~     with pegylated interferon (PEG-IFN) monotherapy.~   "
262427|NCT00114348|"~     The protocol ALL-REZ BFM 2002 aims at the optimization of treatment for children with~     relapsed acute lymphoblastic leukemia. The primary objective of study ALL-REZ BFM 2002 is the~     randomized comparison of a lower dosed and less intensive, but continuous consolidation~     therapy with conventional therapy administered in treatment blocks. Outcome measures are the~     reduction of minimal residual disease (MRD), event-free and overall survival, and the~     toxicity associated with each treatment strategy.~   "
262428|NCT00114335|"~     This small cross-sectional epidemiological study is designed to evaluate the prevalence of~     the following parameters in hospitalized patients in a tertiary teaching hospital (medical~     department only):~        -  kidney insufficiency~        -  obesity~        -  use of unfractionated heparins / low molecular weight heparins~        -  other drugs effecting the hemostatic system~   "
262429|NCT00114322|"~     Recurrent fall/winter major depression (known as Seasonal Affective Disorder (SAD)) is a~     prevalent and disruptive disorder whose pathophysiological basis is unknown, but several~     hypotheses attribute a causal role to the circadian timing system. Bright white light~     exposure via the retina has been shown to reverse the symptoms of SAD. Recent physiological~     studies demonstrated the existence of retinal ganglion cells capable of transducing light~     input to the retinohypothalamic tract, the primary circadian afferent in humans. This~     retinohypothalamic system appears to be maximally sensitive to light in the 446-477nm~     (violet/blue) range.~      Using light-emitting diode (LED) technology, light of narrow bandwidths now can be delivered~     from a safe, relatively inexpensive device. We propose to contrast in SAD patients the~     efficacy and tolerability of 468 nm LED light from a portable 11cm x 6cm~     commercially-available device (GoLITEÔ) to a broader 400-700 nm wavelength LED-generated~     light housed in an identical device. The broad wavelength (white) light from our LED device~     is similar to that from cool-white fluorescent 10,000 lux devices currently the standard for~     treatment of SAD (see e.g., Lam & Levitt, 1999).~      Twenty-four depressed SAD outpatients will be randomized to a 3-week trial of light therapy~     using either the narrow 468 nm LED source or the broader 400-700 nm LED source, each housed~     in a GoLITEÔ device. Subjects will be given devices and written instruction for administering~     daily treatments at home, 45min every (q) a.m. The devices will be described to subjects in~     terms of wavelength but not specifically described as blue or white. Weekly depression~     ratings and assessments of adverse effects will be obtained by a trained rater blind to the~     treatment condition. Depressive symptoms will be rated weekly by the same trained clinician.~      The following hypotheses will be evaluated:~        -  H1-- Depressed SAD patients will demonstrate greater antidepressant therapeutic benefit~          from the narrow-wavelength (blue) source than from the broad-wavelength (white) source.~        -  H2-- Depressed SAD patients will manifest fewer adverse effects during treatment with~          the narrow-wavelength (blue) source than with the broad-wavelength (white) source.~   "
262430|NCT00114309|"~     This drug is being developed to treat a type of brain cancer, glioma. This study was~     developed to evaluate the safety, time to disease progression and survival rates after~     treatment.~   "
262431|NCT00114296|"~     RATIONALE: Chemoprevention is the use of certain drugs or supplements to keep cancer from~     forming, growing, or coming back. The use of omega-3 fatty acids may prevent breast cancer.~      PURPOSE: This randomized clinical trial is studying how well omega-3 fatty acids work in~     preventing breast cancer in women at high risk of developing breast cancer.~   "
262432|NCT00114283|"~     This phase II trial studies how well lapatinib ditosylate works in treating patients with~     metastatic or recurrent head and neck cancer. Lapatinib ditosylate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
262433|NCT00114270|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may prevent breast cancer by lowering the amount of estrogen the body makes.~     Zoledronate may prevent bone loss caused by letrozole. Giving letrozole together with~     zoledronate may prevent breast cancer and reduce bone loss.~      PURPOSE: This randomized clinical trial is studying letrozole and zoledronate to see how well~     they work compared to letrozole and placebo or placebo alone in treating healthy~     postmenopausal women with high breast density.~   "
262434|NCT00114257|"~     This phase I trial is studying the side effects and best dose of decitabine and FR901228 in~     treating patients with relapsed or refractory leukemia, myelodysplastic syndromes or~     myeloproliferative disorders. Drugs used in chemotherapy, such as decitabine and FR901228,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. FR901228 may also stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving~     decitabine together with FR901228 may kill more cancer cells.~   "
262435|NCT00114244|"~     This randomized phase II is studying how well giving sorafenib with or without gemcitabine~     works in treating patients with metastatic pancreatic cancer. Sorafenib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving sorafenib together with gemcitabine may kill more tumor cells.~   "
262436|NCT00114231|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and~     oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be~     removed.~      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin~     together with radiation therapy works in treating patients who are undergoing surgery for~     stage I rectal cancer.~   "
262437|NCT00114218|"~     This phase II trial is studying how well giving gemcitabine together with docetaxel works in~     treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy,~     such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells.~   "
263475|NCT00100061|"~     The purpose of this study is to determine the role of cranberry-containing products in~     preventing urinary tract infections (UTIs).~   "
262438|NCT00114205|"~     RATIONALE: Giving drugs, such as docetaxel, directly into the pleura after surgery to drain~     the pleural effusion may help keep fluid from building up again.~      PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of~     intrapleural docetaxel given after surgery in patients with malignant pleural effusion.~   "
262439|NCT00114192|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Thalidomide may stop the growth of non-small cell lung cancer by blocking blood flow to the~     tumor. Thalidomide may also help docetaxel work better by making tumor cells more sensitive~     to the drug. Giving docetaxel together with thalidomide may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with thalidomide~     works as second-line therapy in treating patients with stage III or stage IV non-small cell~     lung cancer.~   "
262440|NCT00114179|"~     Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of pancreatic cancer by blocking blood flow to the tumor. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to~     radiation therapy. Bevacizumab may make tumor cells more sensitive to both chemotherapy and~     radiation therapy. Giving chemotherapy and bevacizumab before and after radiation therapy may~     kill more tumor cells. This phase II trial is studying how well giving capecitabine and~     bevacizumab together with radiation therapy followed by gemcitabine and bevacizumab works in~     treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.~   "
262441|NCT00114166|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     topotecan in different dosing schedules may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well topotecan works in treating patients with~     recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.~   "
262442|NCT00114153|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when~     given together with carboplatin followed by radiation therapy in treating patients with stage~     III or stage IV head and neck cancer.~   "
262443|NCT00114140|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together~     with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation~     therapy works in treating patients with low-grade gliomas.~   "
262444|NCT00114127|"~     The purpose of this study is to examine the safety and efficacy of duloxetine for the~     treatment of social anxiety disorder.~   "
262445|NCT00114114|"~     The purpose of this study is to determine the levels of testosterone and/or estradiol at~     which changes in bone turnover, body composition, strength, sexual function etc. begin to~     occur. This information may help determine when to intervene with hormone replacement therapy~     in aging men.~   "
262446|NCT00114101|"~     This randomized phase III trial studies lenalidomide to see how well it works compared to a~     placebo in treating patients with multiple myeloma who are undergoing autologous stem cell~     transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any~     cancer cells that are in the body and helps make room in the patient's bone marrow for new~     blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the~     patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for~     the stem cell transplant. The stem cells are then returned to the patient to replace the~     blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as~     lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer~     cells from growing. Giving lenalidomide after autologous stem cell transplant may be an~     effective treatment for multiple myeloma.~   "
262447|NCT00114088|"~     STOP-DUB is a multicenter randomized clinical trial that is assessing the efficacy and~     effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine~     bleeding (DUB) in women for whom medical management has not provided relief.~   "
262448|NCT00114075|"~     The purpose of this study is to evaluate the effects of pre-operative gait analysis testing~     on surgical outcomes in children with cerebral palsy who have problems walking.~   "
262449|NCT00114062|"~     The purpose of this study is to determine whether denufosol tetrasodium (INS37217)~     Intravitreal Injection is well tolerated and has the potential to treat uveitis associated~     macular edema.~   "
262450|NCT00114049|"~     The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in~     treating the signs and symptoms of dental pain following third molar tooth extraction.~   "
262451|NCT00114036|"~     The specific aims are to determine the incidence of medication errors related to~     antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and~     hysterectomies across a heterogeneous sample of hospitals; identify organizational and~     practitioner factors associated with error rates, and evaluate the effectiveness of a~     multifaceted intervention in reducing prophylaxis error rates compared to written feedback~     alone in a sample of 44 hospitals enrolled in the study using a rigorous group-randomized~     design.~   "
262452|NCT00114023|"~     This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely~     cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study~     evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for~     the treatment of AK.~   "
262864|NCT00108407|"~     The purpose of this study is to determine whether Integrated Cognitive Behavioral Therapy or~     Twelve Step Facilitation Therapy is most effective for treatment of dually diagnosed veterans~     with depressive and substance use disorders.~   "
262453|NCT00114010|"~     This study will examine the safety and immune response of healthy adult volunteers to~     AMA1-C1, an experimental malaria vaccine developed by the NIAID. Malaria affects about 300~     million to 500 million people worldwide each year, causing from 2 million to 3 million~     deaths. Increasing drug resistance to the malaria parasite, as well as widespread resistance~     of mosquitoes (the insects that transmit the parasite) to pesticides are reducing the ability~     to control malaria through these strategies. A vaccine that could reduce illness and death~     from malaria would be a valuable new resource in the fight against this disease. Early tests~     of AMA1-C1 in 66 people in the United States and in Mali, West Africa, found no serious side~     effects of the vaccine. This study will test a shorter schedule of vaccinations with AMA1-C1~     than that used in the previous studies.~      Healthy volunteers between 18 and 50 years of age who weigh at least 110 pounds and with no~     travel to malaria endemic areas in the past 12 months may be eligible for this study.~     Candidates are screened with a medical history and physical examination, blood and urine~     tests, and a urine pregnancy test for women who are able to bear children.~      Participants are randomly assigned to receive three injections of either the experimental~     malaria vaccine or a placebo (a solution that does not contain the vaccine) over a 2-month~     period. The shots are given in an upper arm muscle, each 1 month apart. On the day of each~     injection, participants give a history of symptoms since the last visit, have a brief~     physical examination and blood test and, for women, a blood or urine pregnancy test. After~     the injection, participants remain in the clinic 60 minutes for observation. In addition to~     the injections, participants undergo the following procedures:~        -  Record temperature and symptoms on a diary card daily for the first 7 days after each~          injection.~        -  Follow-up clinic visits 1, 3, 7 and 14 days after each shot to check for side effects.~          Blood samples are drawn before each injection and at each return clinic visit to check~          the safety and immune response to the vaccine.~        -  Have apheresis, a special procedure that separates certain components of the blood, 7~          days after each injection to measure the function of germ-fighting blood cells. For this~          procedure, blood is drawn through a needle in an arm vein and directed into a machine~          that separates the different types of blood cells. The white cells are collected in a~          plastic ...~   "
262454|NCT00113997|"~     This 1-week study will test the safety and dosing of an anticoagulation system called REG1~     that is designed to improve control of blood thinning. Patients with heart attack and other~     conditions require treatment with an anticoagulant (blood thinner) to prevent the formation~     of blood clots. However, anticoagulation therapy can increase the risk of bleeding. The REG1~     system is designed to minimize this risk. One part of the system stops the activity of factor~     IX (a protein that helps blood clot) while the other part of the system (the antidote)~     inactivates the drug and stops the thinning process. This study will examine in normal~     healthy subjects how the REG1 system works in the body and how it leaves the body.~      Healthy normal volunteers between 12 and 65 years of age who weigh 50-120 kilograms (110-264~     pounds) and have no history of bleeding problems or significant bleeding may be eligible for~     this study. Candidates are screened with a medical history, physical examination, and blood~     tests.~      Participants must avoid foods that may alter the blood's clotting ability and must not take~     any medications the week of the study. They undergo the following tests and procedures:~      Day 1~      Subjects are admitted to the NIH Clinical Center for an overnight stay. Two catheters~     (plastic tubes) are placed in the subject's arm veins, one for drawing blood samples and the~     other for injecting one of the following: REG1 drug, REG1 antidote, REG1 drug and antidote,~     or placebo. Two injections of study medication are given, spaced 3 hours apart, each over a~     1-minute period. After each injection, blood is collected at specific times to measure levels~     of the drug or antidote in the body and the blood's ability to clot. Subjects also provide a~     24-hour urine collection and stool sample.~      Day 2~      A blood sample is drawn 24 hours after the drug or antidote injection from the previous day.~     If the blood test result is normal, subjects are discharged home with instructions to follow.~     They return to the Clinical Center at 36 hours and 48 hours for additional blood samples.~      Days 3 and 7~      A blood sample is collected at the end of day 3 and day 7. Urine and stool samples are also~     collected.~   "
262455|NCT00113984|"~     This study will evaluate the side effects of a fixed dose of vaccine and GM-CSF with~     increasing doses of anti-CTLA-4 antibody in patients with advanced prostate cancer. The~     vaccine consists of a priming vaccine called PROSTVAC/TRICOM, made from vaccinia virus, and~     a boosting vaccine called PROSTVAC-F/TRICOM, made from fowlpox virus. GM-CSF is a chemical~     that boosts the immune system, and anti-CTLA-4 antibody is a protein that may improve~     anti-tumor activity and the response to the vaccines. DNA is inserted into the priming and~     boosting vaccine viruses to cause production of proteins that enhance immune activity and~     also to produce prostate specific antigen (PSA)-a protein that is normally produced by the~     patient's tumor cells.~      Patients 18 years of age and older with androgen-insensitive prostate cancer that has spread~     beyond the original site may be eligible for this 7-month study. Candidates must have disease~     that has worsened despite treatments with hormones and up to one chemotherapy regimen. Their~     tumor must produce PSA, and they must have no history of allergy to eggs or egg products~     Candidates are screened with a medical history and physical examination, blood and urine~     tests, electrocardiogram, pathological confirmation of the diagnosis and presence of the PSA~     marker, chest x-rays, imaging studies to assess the extent of tumor, and, if clinically~     indicated, a cardiologic evaluation.~      Participants receive the priming vaccination on study day 1. After 2 weeks and then again~     every 4 weeks while on the study, they receive a boosting vaccine. All vaccines are injected~     under the skin. On the day of each vaccination and daily for the next 3 days, patients~     receive an injection of GM-CSF to increase the number of immune cells at the vaccination~     site. On the day of the first six boosting vaccinations, they receive anti-CTLA-4 antibody as~     an infusion through a vein over 90 minutes.~      Patients are monitored for safety and treatment response with the following tests and~     procedures:~        -  Blood and urine tests monthly, or more often if needed, to monitor liver, kidney, and~          other organ function.~        -  Imaging studies to assess the tumor before starting treatment, again around study days~          99 and 183, and then every 3 months after that while on study.~        -  Apheresis (a procedure for collecting immune cells called lymphocytes) to measure the~          immune response to treatment. Apheresis is done three times: before starting the study~          and again around study days 99 and 183. For this procedure, blood is collected through a~          needle in an arm vein. The blood circulates through a machine that separates it into its~          components by spinning, and the lymphocytes are extracted. The rest of the blood is~          returned to the patient through the same needle. This will only be done in participants~          who have the tissue marker HLA-A2 (about 50% of patients).~      Patients whose disease responds to treatment and who do not develop severe side effects may~     continue treatment beyond the initial 7-month study period on vaccine alone (without the~     antibody). After treatment is completed, patients are monitored for up to 15 years. This~     includes a medical history and physical examination for 5 years following the last~     vaccination. Information beyond 5 years is collected once a year by telephone.~   "
262456|NCT00113971|"~     The goal of this study is to evaluate how epratuzumab is processed by the body~     (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in~     patients with SLE.~   "
262457|NCT00113958|"~     The purpose of this study is to observe the effects of a treatment strategy that incorporates~     cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) to K/DOQI~     recommended targets in subjects with end stage renal disease (ESRD) receiving hemodialysis,~     on bio-intact parathyroid hormone, corrected serum calcium, serum phosphorus, and calcium~     phosphorus product.~   "
262458|NCT00113945|"~     The purpose of this study is to observe the effects of a treatment strategy that incorporates~     cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) in subjects with~     ESRD receiving hemodialysis, on bio-intact parathyroid hormone (biPTH), corrected serum~     calcium, serum phosphorus, and calcium phosphorus product.~   "
262459|NCT00113932|"~     The purpose of this study is to find out if treating multiple myeloma (MM) patients with more~     intense chemotherapy and autologous transplant (high dose density therapy) early in the~     disease course will result in better treatment outcomes compared to patients treated in the~     past.~   "
262460|NCT00113919|"~     The purpose of this study is to find out if patients with high risk disease because of age or~     kidney status can be treated more safely with a drug called Busulfex® followed by autologous~     transplant compared to treatment with the standard drug called melphalan, which has been~     shown to be quite difficult to tolerate in patients with poor kidney function and patients~     over the age of 65 when given in high doses.~   "
262461|NCT00113906|"~     Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized~     clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep~     disturbances and general wellbeing.~   "
262462|NCT00113893|"~     The purpose of this study is to determine the safety and effectiveness of oral SCIO-469 in~     patients with myelodysplastic syndromes. SCIO-469 belongs to a new class of treatments that~     inhibit expression and activity of cytokines that play a role in the progression of MDS.~   "
262463|NCT00113880|"~     The purpose of this study was to expand the data describing the safety profile of FluMist in~     the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of~     annual revaccination in those who received FluMist in 2 or more consecutive years.~   "
262464|NCT00113867|"~     The purpose of this study is to examine the effects of marked alterations in ovarian steroid~     hormones on cognitive functions in women. Sex hormones and stress hormones of women awaiting~     or undergoing in-vitro fertilization (IVF) will be compared with levels of women adopting~     children and women on oral contraceptives.~   "
262465|NCT00113854|"~     Cerebral malaria is a life-threatening complication of Plasmodium falciparum infection in~     African children and nonimmune travellers despite availability of quinine, the current drug~     of choice. Several reports have suggested that raised intracranial pressure (ICP) is a major~     cause of death among children with cerebral malaria. Mannitol, an osmotic diuretic,~     effectively lowers ICP and is used to treat post traumatic raised ICP. There have been some~     case reports of reduction in mortality and morbidity in African children with cerebral~     malaria following administration of mannitol, but as these were not randomized controlled~     trials it is difficult to evaluate their significance. This study seeks to establish whether~     a single dose of intravenous mannitol given to children with cerebral malaria will~     significantly reduce the coma recovery time.~   "
262511|NCT00113256|"~     Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the~     current estimate of overall survival as a study endpoint prior to launching the blinded~     randomized phase (versus gemcitabine and placebo) of the study. Toxicity of the drug~     combination will also be evaluated.~   "
262466|NCT00113841|"~     Primary Objectives:~        1. To evaluate clinical tolerance and response to curcumin alone and in combination with~          Bioperine in patients with multiple myeloma.~        2. To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin +~          Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin.~        3. To evaluate the biologic effects of curcumin alone and in combination with Bioperine on~          the expression of NF-kB and related genes in the Multiple Myeloma (MM) cells.~   "
262467|NCT00113828|"~     The purpose of this trial is to determine if patients with hematologic diseases who have a~     HLA 6/6 matched related donor and are not eligible for a standard myeloablative stem cell~     transplant will have less severe graft versus host disease (GVHD), transplant related~     mortality, and less graft failure when treated with a non-myeloablative T-cell depleted stem~     cell transplant.~   "
262468|NCT00113815|"~     The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate~     in infants with refractory partial onset seizures (POS).~   "
262469|NCT00113802|"~     The purpose of this study is to determine whether epratuzumab provides effective therapy in~     Waldenström's Macroglobulinemia (WM).~   "
262470|NCT00113789|"~     This trial will provide data on the safety and efficacy of pegfilgrastim, in terms of~     duration of grade 4 neutropenia, when administered on the last day or the day after a~     multi-day, myelosuppressive chemotherapy regimen for ovarian cancer.~   "
262471|NCT00113776|"~     The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in~     subjects with metastatic colorectal cancer who were previously randomized to best supportive~     care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.~   "
262472|NCT00113763|"~     The purpose of this study is to determine that panitumumab, using the proposed regimen, will~     safely increase progression free survival in patients with metastatic colorectal cancer who~     have failed available treatment options (i.e., patients who developed progressive disease or~     relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).~   "
262473|NCT00113750|"~     Tree MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide~     pre-seasonal specific immunotherapy for patients with hypersensitivity to tree (birch, alder,~     and hazel) pollen. Different doses of Tree MATA will be administered and immunological~     changes following this treatment will be assessed.~   "
262474|NCT00113737|"~     To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves~     the depression-prone smoker's ability to quit.~   "
262475|NCT00113724|"~     Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is~     synthetically manufactured from naturally occurring taxanes extracted from yew starting~     material. The synthesis involves modification to the taxane side chain to overcome multidrug~     resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose~     escalation, sequential group, phase I study evaluating the intravenous administration of TPI~     287, a novel third generation taxane.~   "
262476|NCT00113711|"~     To test whether a behavioral intervention could indeed achieve the dual goals of promoting~     smoking cessation and minimizing weight gain.~   "
262477|NCT00113698|"~     This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition~     (ACE-I) therapy for the treatment of mitral regurgitation (MR).~   "
262478|NCT00113685|"~     The purpose of this study is to evaluate the clinical outcome of patients following blunt~     traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or~     hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic~     outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory~     cell responsiveness.~   "
262479|NCT00113672|"~     The purpose of this study is to examine the impact of diet and exercise on an individual's~     health.~   "
262480|NCT00113659|"~     The goal of the study is to understand the mechanisms of how antigen presentation affects the~     developing immune system and subsequently affects susceptibility to, or protects against,~     asthma development. This randomized controlled study will test the effectiveness of daily~     supplementation of Lactobacillus GG for the first 6 months of life on the early immunological~     development of asthma.~   "
262481|NCT00113646|"~     The purpose of this study is to determine if recipients of non-myeloablative ex-vivo T-cell~     depleted peripheral blood (PBSC) stem cell transplantation using a mismatched related donor~     will have less severe graft versus host disease (GVHD), transplant related mortality, and~     less graft failure compared to alternative haploidentical stem cell transplantation.~   "
262482|NCT00113633|"~     The study will assess the efficacy of a three-part Emergency Department (ED)-based Asthma~     Belief and Control intervention on healthcare utilization, asthma controller medication use,~     symptoms, and quality of life during the 6 months following an Emergency Department visit.~   "
262483|NCT00113620|"~     The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine~     are effective in the treatment of pain of diabetic neuropathy.~   "
262484|NCT00113607|"~     The purpose of the study is to compare the progression-free survival (PFS) of the combination~     of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.~   "
262485|NCT00113594|"~     The purpose of this study is to characterize olanzapine pharmacokinetics: the inter- and~     intra- subject variabilities of olanzapine pharmacokinetics; and the potential influence of~     patient factors such as age, weight, gender, origin, and smoking status on olanzapine~     pharmacokinetics in adolescents with schizophrenia or bipolar I disorder. This study will~     also assess the safety of olanzapine delivered orally.~   "
262486|NCT00113581|"~     The main purpose of this study is to test the safety and tolerability and effectiveness of a~     new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination~     with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).~      In addition the study will look at pharmacokinetic (how the the body takes up the drug) and~     pharmacodynamic parameters (what the drug does in the body).~   "
262487|NCT00113568|"~     The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual~     bleeding associated with menorrhagia.~   "
262512|NCT00113243|"~     The purpose of this study is to determine if bone marrow derived adult stem cells are safe~     and effective in inducing development of new blood vessels (angiogenesis) in the legs of~     patients with severe peripheral vascular disease.~   "
262488|NCT00113555|"~     The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive~     surgical procedure in up to 160 implanted female patients in which two adjustable balloons~     (one on each side of the urethra) are implanted to treat urinary stress incontinence.~      The results will be analyzed to demonstrate the effects of the device as well as its~     associated risks. Therapeutic success will be based on whether the patients demonstrate at~     least a one-grade (mean) reduction in the Stamey score at 12 months.~   "
262489|NCT00113542|"~     Psoriasis is a common skin disease affecting an estimated 2.6% of the US population. It is a~     chronic, recurrent condition for which there is no cure, but there are ways to control it.~     Psoriasis is characterized by epidermal hyperplasia (abnormal increase in the number of~     normal cells of the outer layer of the skin). Tetrathiomolybdate (TM), a copper chelator (a~     drug that removes copper from the bloodstream) was first created to treat Wilson's disease, a~     disorder caused by too much copper in the blood. Studies in animals have since shown that TM~     may also prevent the formation of new blood vessels and may also block the key components of~     inflammation (swelling, redness, and pain) caused by psoriasis. TM is not approved by the FDA~     for any use yet. It is an investigational drug used for clinical research. We propose to test~     whether a new treatment with TM can in fact improve or stabilize psoriasis.~   "
262490|NCT00113529|"~     To assess the maximum tolerated dose and overall safety and tolerability of sunitinib~     [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients~     with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the~     combination of gefitinib and sunitinib (Phase 2).~   "
262491|NCT00113516|"~     The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit~     when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and~     also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell~     Lung Cancer (NSCLC).~   "
262492|NCT00113503|"~     This study will compare two different dosing methods of azathioprine (IMURAN) in participants~     with Crohn's disease who are currently taking steroids (e.g. prednisone or budesonide)or who~     have just started steroids. The study can be up to 54 weeks long. All participants enrolled~     will receive active drug. Participants will take doses either based upon weight or based on~     the patient's ability to breakdown the drug (monitored by 6-thioguanine nucleotides (6-TGN)~     metabolite levels in the blood). All patients enrolled in the study will receive active study~     drug.~   "
262493|NCT00113490|"~     The primary objective of this study was to determine the effect on immune reactivity to~     motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524)~     administered for a second season in children.~   "
262494|NCT00113477|"~     The purpose of this study is to determine whether supplements of Q10 and Selen are effective~     in reducing muscular adverse events (AE) in statin therapy.~   "
262495|NCT00113464|"~     This study will explore screening for immunodeficiency diseases (diseases that cause problems~     in fighting infections). There is no method at present to screen all babies at birth for~     immunodeficiency. However, babies with low numbers of T-cells-an important type of immune~     system cell-may be found by studying T-cell products called TRECs (T-cell receptor excision~     circles). This study will:~        -  Collect samples from children with several different immunodeficiencies to find out~          which disorders can be found by screening dried blood spots for TRECs.~        -  Try to develop screening tests based on other kinds of material derived from dried blood~          spots.~      Children with primary immunodeficiency and low numbers of T cells who have not had a bone~     marrow transplant may be eligible for this study.~      Participating children donate up to 5 ml (1 teaspoon) of blood. The sample may be collected~     when the child is having other blood tests. The liquid blood is analyzed to determine the~     number of T cells, and the rest of the blood is used to make dried blood spots on filter~     paper. The blood spots are used to develop screening tests for immunodeficiency. The blood~     spots and data about the child's age, diagnosis, and current medicines will be kept coded by~     diagnosis and a code number instead of the child's name.~   "
262496|NCT00113451|"~     The purpose of this study is to answer, among others, the following questions: 1) What are~     the outcomes when using the radial artery as a bypass graft in coronary artery bypass surgery~     (CABG)? 2) Can multidetector computed tomography (CT) be used to reliably evaluate coronary~     artery bypass graft patency?~   "
262497|NCT00113438|"~     This is a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate (CA4P)~     combined with the chemotherapy drugs, carboplatin and paclitaxel. The full treatment and~     observation time should be about 5 months. During this time the patient should receive 18~     CA4P infusions and 6 carboplatin followed by paclitaxel treatments. Patients will be~     randomized into one of two CA4P dose-level groups in order to recommend a preferred~     dose-level for future studies. At least 2 dynamic contrast enhanced-magnetic resonance~     imaging (DCE-MRI) scans will be conducted to monitor the blood flow through the tumor before~     and after treatment with CA4P.~   "
262498|NCT00113425|"~     The purpose of this research project is to study the effect of non-ablative (non-cutting)~     laser therapy, a technique that uses laser energy to try to improve the appearance of the~     skin. This type of laser treatment creates changes in a layer of the skin called the dermis~     without causing an open wound in the skin. The use of non-ablative laser therapy, together~     with application of a photo-sensitizer (substance that makes the skin more sensitive to~     light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it~     is supposed to make the laser more effective than using just the laser alone. It is not yet~     clear how much improvement can be seen with these treatments or exactly how the skin's~     response causes these improvements. In this study, we are interested in learning how well~     such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer~     actually enhances the efficacy of the laser.~   "
262534|NCT00112931|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. It is not yet known whether~     rituximab is more effective than observation in treating non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying rituximab to see how well it works~     compared to observation in treating patients with newly diagnosed stage II, stage III, or~     stage IV follicular non-Hodgkin's lymphoma with no symptoms.~   "
262499|NCT00113412|"~     One measurement of an HIV infected person’s risk of progressing to AIDS is the number of~     viral particles of HIV in their blood (called a “viral load”). In a previous phase I/II~     study, SP01A was observed to significantly lower the amount of HIV in blood, improve quality~     of life (how well subject's felt), have a favorable safety profile (minimal side effects),~     and be well tolerated. Moreover, in in vitro testing SP01A: (1) demonstrated comparable or~     greater efficacy than currently approved anti-HIV drugs in preventing HIV virus replication;~     (2) was observed to have minimal toxic effect on human cells; and (3) demonstrated~     significant efficacy in preventing virus replication of HIV virus strains that resist~     currently approved anti-HIV treatments. Based on these results, SP01A demonstrates promise as~     a new and novel anti-HIV treatment.~      The goal of this study is to further look at the dose response, efficacy, and safety of SP01A~     as monotherapy, given as a capsule to be swallowed, in the treatment of HIV-infected~     subjects. The investigators want to see if SP01A will lower the amount of HIV in blood.~      Subjects will be assigned by chance to 1 of 4 groups. Neither the subject nor the study~     doctor or nurse will know which dose of the study drug the subject is taking or if the~     subject is receiving the placebo (a capsule that looks like the study drug but does not~     contain any active ingredient).~      At the end of the 10-day study, the subject will be offered testing of their virus for~     resistance to approved drugs (genotype) and transferred to their physician for continued~     treatment with FDA-approved antiretroviral therapies. If the subject experiences a side~     effect, which continues past the end of the study, they will be further monitored until the~     side effect goes away.~   "
262500|NCT00113399|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more~     sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and~     giving them with radiation therapy may kill more tumor cells. It is not yet known whether~     giving radiation therapy together with combination chemotherapy is more effective than giving~     combination chemotherapy alone in treating head and neck cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy and combination~     chemotherapy to see how well they work compared to combination chemotherapy alone in treating~     patients with recurrent head and neck cancer that cannot be removed by surgery.~   "
262501|NCT00113386|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and~     docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug~     (combination chemotherapy) together with radiation therapy before surgery may shrink the~     tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that~     remain after surgery. It is not yet known whether giving cisplatin and docetaxel together~     with radiation therapy is more effective than giving cisplatin together with docetaxel in~     treating non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation~     therapy to see how well they work compared to cisplatin and docetaxel in treating patients~     who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.~   "
262502|NCT00113373|"~     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. This phase II trial is studying how well lapatinib works in treating patients with~     persistent or recurrent ovarian epithelial or peritoneal cancer.~   "
262503|NCT00113360|"~     Objectives:~      Primary endpoint:~      -Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free~     survival (PFS) duration defined by RECIST criteria in treated and untreated patients with~     metastatic, unresectable low grade neuroendocrine carcinoma.~      Secondary endpoints:~        -  Assess the progression free survival duration of patients with metastatic, unresectable~          low grade neuroendocrine carcinoma treated with RAD 001 plus depot octreotide.~        -  Assess the safety of RAD 001 plus depot octreotide in patients with metastatic,~          unresectable low grade neuroendocrine carcinoma.~        -  To determine the expression/phosphorylation status of the components of the mTOR~          signaling pathway in the primary tumors, in order to determine whether these markers can~          be used as predictors of sensitivity to the combination of RAD001 and octreotide.~        -  To determine the effect of the combination of RAD001 and octreotide on the expression~          and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to~          identify potential pharmacodynamics markers of response to this drug combination.~        -  To observe the effects of treatment with RAD001 on plasma angiogenic biomarkers.~   "
262504|NCT00113347|"~     The goal of this clinical research study is to find the highest safe dose of the drugs~     OSI-774 and docetaxel that can be given together along with radiation treatment for advanced~     head and neck cancer.~   "
262505|NCT00113334|"~     The goals of this clinical research study are to see how individuals with advanced head and~     neck cancer respond to treatment with the new drug thrombospondin (ABT-510) and to learn how~     effective it is in destroying cancer cells. The safety of ABT-510 and the effect ABT-510 has~     on cells in the body will also be studied.~   "
262506|NCT00113321|"~     To study if decitabine can help to control Myelodysplastic Syndrome (MDS) in patients who~     have failed on therapy with azacytidine, the current standard of therapy.~   "
262507|NCT00113308|"~     This study is being conducted to find out if an investigational drug called GW406381 can help~     people with rheumatoid arthritis.~   "
262508|NCT00113295|"~     The purpose of this study is to examine the safety and efficacy of quetiapine for generalized~     anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR.~   "
262509|NCT00113282|"~     Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients with a CD4~     cell count over 200/mm3, but its activity in patients with treatment failure and low CD4 cell~     counts is unknown. This study will test the efficacy and safety of IL-2 with an optimized~     antiretroviral regimen in patients with a CD4 count below 200/mm3 and a plasma viral load~     above 10,000 HIV RNA copies/ml.~   "
262510|NCT00113269|"~     The purpose of this study is to compare the safety and efficacy of different induction agents~     (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients~     treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.~   "
262513|NCT00113230|"~     Preoperative chemoradiation leads to increased pelvic control and overall survival, but both~     distant and local disease control remain problematic in locally advanced rectal cancer~     patients. Enhancing the effect of chemotherapy and radiotherapy can increase tumor response~     as well as distant disease control. Patients who have complete response to therapy have~     increased sphincter preservation, and can possibly have more limited surgery (full thickness~     local excision). When combined with standard chemotherapy, bevacizumab [RHUMAB VEGF, Avastin]~     has been shown to improve response and median survival in patients with metastatic colorectal~     cancer in a recent randomized trial, has led to increased activity in preclinical studies~     with radiotherapy, and has been found to be very well tolerated with chemoradiation in a~     phase I trial conducted at the M.D. Anderson Cancer Center (MDACC) in patients with locally~     advanced pancreatic cancer. The hypothesis is that the addition of bevacizumab to standard~     chemoradiation will safely lead to increased tumor response in patients with locally advanced~     rectal cancer.~   "
262514|NCT00113217|"~     The goal of this clinical research study is to learn if bevacizumab (Avastin®) can control~     metastatic renal cell carcinoma (RCC). The safety of the treatment will also be studied.~      Objectives:~      Primary:~        1. To assess the efficacy of neoadjuvant therapy of bevacizumab by evaluating time to~          progression.~        2. Toxicities of therapy with bevacizumab in RCC.~      Secondary:~      Clinical:~        1. Response rate~        2. Duration of response~        3. Overall Survival~      Preclinical:~        1. Serum and plasma levels of matrix metalloproteinase 9 (MMP-9) and MMP-2, Interleukin 6~          (IL-6), vascular endothelial growth factor (VEGF), and Basic Fibroblast Growth Factor~          (bFGF) pre- and post- therapy (optional studies).~        2. Tissue expression of Phospho-epidermal growth factor receptor (EGFR), VEGF, vessel count~          CD31/34, AKT and Phospho-AKT, mitogen-activated protein kinase (MAPK), transforming~          growth factor-alpha (TGF-alpha), phospho-STAT3 and TUNEL post therapy (optional~          studies).~        3. complementary DNA (cDNA) microarray analysis of tissue post-therapy (optional studies).~        4. Tissue expression of tumor infiltrating lymphocytes and tumor antigens~        5. Pathological response rate in primary tumor.~        6. To evaluate the Single Nucleotide Polymorphisms (SNP) patterns in nephrectomy specimens~          from patients participating in the study.~   "
262515|NCT00113204|"~     This is a phase 1 clinical trial to find the safe, maximum tolerated dose of IPI-504 in~     patients with relapsed and/or relapsed, refractory multiple myeloma. This study will examine~     how IPI-504 is absorbed, distributed, metabolized, and eliminated by the body. The study will~     also evaluate potential anti-tumor activity of IPI-504.~   "
262516|NCT00113191|"~     The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human~     immune globulin intravenous (IGIV), can prevent an infection in the blood caused by~     staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth.~      Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or~     placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study~     Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.~   "
262517|NCT00113178|"~     The purpose of this study is to evaluate the safety and efficacy of right atrial~     intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial~     flutter.~   "
262518|NCT00113165|"~     This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine)~     extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release~     is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but~     do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets~     will be added to current seizure treatments.~   "
262519|NCT00113152|"~     This study will explore what may cause people with sickle cell anemia to have heart problems~     and an increased risk of sudden death.~      People 18 years of age and older with sickle cell anemia may be eligible for this study.~     Candidates are screened with a medical history and physical examination, electrocardiogram~     (EKG), echocardiogram (heart ultrasound), and blood tests.~      Participants undergo the following tests and procedures:~        -  Holter monitoring: The patient wears a small, battery-operated device to record heart~          rate and rhythm over 24 to 48 hours.~        -  QRST surface mapping: An EKG using 64 electrodes is done at rest and during exercise to~          provide a detailed look at the heart and its conduction system.~        -  Chest x-rays are taken to examine the lungs.~        -  Bicycle exercise echocardiography test: Blood pressure, pulse, heart rhythm and oxygen~          use are monitored while the patient exercises on a stationary bicycle. Ultrasound~          pictures are also obtained during the exercise.~        -  Echocardiogram: A heart ultrasound is done to check how well the heart is pumping blood.~        -  Pulmonary artery catheterization: A catheter (plastic tube) is inserted into a vein and~          advanced to the chambers of the heart, through the heart valve and into the lung artery.~          The pressures in the heart and lung blood vessels are measured while the patient is~          resting and during exercise, with the bed tilted up and down, and after giving 500 mls~          of fluid into a vein.~        -  Blood tests are done to measure a hormone called brain natriuretic peptide, which can~          increase with the development of heart failure, and nitrite, a substance that can affect~          blood vessel dilation. Some blood is stored to test for inflammatory markers and for~          possible future gene and protein analysis.~        -  Cardiac magnetic resonance imaging (cMRI): The patient lies in a donut-shaped magnet~          while pictures of the heart are obtained using a magnetic field and radio waves.~          Earplugs are worn to muffle the loud sounds that occur with electrical switching of the~          magnetic fields. A contrast agent called gadolinium may be injected to enhance the~          quality of the images.~        -  Invasive electrocardiographic (reveal) monitoring: This procedure permits study of the~          heart rhythms over a long time period. A small device is placed just under the skin on~          the left side of the chest. It can be left in for up to 14 months to monitor the~          heartbeat continuously during this time.~   "
262520|NCT00113139|"~     The purpose of this study is to examine the effectiveness of a telephone-based cognitive~     behavioral therapy intervention to alleviate psychological distress among lung transplant~     patients.~   "
262521|NCT00113126|"~     Treatment of HIV repairs the immune system, but continuous treatment is expensive and causes~     side effects. Would it not be better to treat intermittently, e.g. stop treatment when the~     immune system has recovered, and start again only when damage reappears? That is the question~     which STACCATO proposes to answer.~      Approximately 500 patients were recruited for this trial from 2002 to 2004. One third were~     treated continuously; in two thirds, the treatment was interrupted whenever the CD4 count, a~     measure of immune recovery, exceeded 350. At the end of 2005, the two treatment groups will~     be compared in order to see which fared better regarding amount of drugs used, side effects,~     CD4 counts, and development of resistance to treatment.~   "
262522|NCT00113113|"~     Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to~     define the maximum tolerated dose and the dose-limiting toxicity in this patient population,~     and to perform pharmacokinetic studies of rubitecan in this patient population.~   "
262865|NCT00108394|"~     The purpose of this study is to demonstrate whether pamidronate will preserve or increase~     bone mass in patients with adynamic bone disease, caused by low bone turnover.~   "
262523|NCT00113100|"~     The purpose of this study is to investigate the way by which estrogen improves the appearance~     of sun damaged human skin. Accumulating evidence suggests that estrogen, taken by post~     menopausal women, may cause skin to look younger as a consequence of reduced wrinkles.~     Collagen is the most abundant protein in human skin and gives skin its strength and shape.~     Recent data indicate that short-term topical estrogen (17-beta estradiol) treatment increases~     collagen production in sun damaged skin. This study will compare the molecular and~     microscopic effects from topical 17-beta estradiol (E2) when applied to the skin for a~     short-term duration. It is anticipated that the new knowledge from this study will enable~     development of new ways to improve the function of aged skin.~   "
262524|NCT00113087|"~     This study will evaluate the efficacy and safety of administering an angiotensin converting~     enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study~     will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the~     effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental~     and functional status, ventricular geometry, function, and atrioventricular (AV) valve~     regurgitation. In addition, the study will determine the relationship between genetic~     polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I~     therapy and compare the incidence of adverse events in subjects treated with ACE-I with those~     in subjects treated with placebo.~   "
262525|NCT00113074|"~     The purpose of this study is to develop effective interventions that assist individuals with~     high blood pressure to quit smoking and prevent weight gain.~   "
262526|NCT00113061|"~     The purpose of this study is to determine the effect of exercise training on elevated~     C-reactive protein (CRP) concentrations, an indicator of inflammation, in initially inactive~     women and men.~   "
262527|NCT00113048|"~     This phase I study will involve escalating doses of CAMPATH until the goal dose for the~     cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously~     (SQ) 3 times per week for up to 12 weeks.~   "
262528|NCT00113035|"~     Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The primary objective of this study is to identify potential candidates for~     future clinical studies in Pompe disease.~   "
262529|NCT00113022|"~     This study will evaluate the effectiveness of the experimental drug, Org 24448, for~     short-term treatment of depression. It will examine the effects of the drug on symptoms, such~     as low mood and persistent sadness, poor sleep and appetite, poor motivation and lack of~     enjoyment of things people normally enjoy, negative thinking, and feeling slowed down or~     having trouble concentrating. It will also assess whether the drug improves cognitive~     function, especially memory.~      Patient with major depression who do not have a serious, unstable medical illness and who are~     21 to 55 years of age may be eligible for this study. Candidates are screened with a~     psychiatric and medical history, diagnostic interview, physical examination,~     electrocardiogram, blood tests and, for women, a pregnancy test.~      Participants are tapered off anti-depression drugs (and any other medications not allowed on~     the study) over a 3-week period and then begin a 2-week drug-free period. During these 2~     weeks they have an electroencephalogram (EEG) with light stimulation, and those whose EEG~     indicates a seizure disorder are excluded from the study. Also at the beginning of the~     drug-free period they begin taking a placebo (sugar pill) twice a day. After 2 weeks on~     placebo, some patients begin treatment with Org 24448, while others remain on placebo. They~     continue the medication for 8 weeks, during which time they have a weekly check of vital~     signs, blood and urine tests, and rating scales for depression and anxiety. Level of~     functioning is evaluated twice during the study. After 8 weeks of treatment, patients have a~     physical exam, electrocardiogram (ECG), EEG, blood tests, and begin to come off the study~     drug, tapering the medication over a week.~      In addition to the above procedures, some patients undergo the following tests during the~     2-week drug-free period and again toward the end of the 8-week medication phase:~        -  Neuropsychological testing, including measurements of cognitive abilities such as~          memory, attention, problem-solving, and language skills.~        -  Positron emission tomography (PET): This nuclear medicine test provides information~          about different brain regions. The patient lies on a table in the PET scanner (similar~          to a computed tomography (CT) scanner), with a mask placed over his or her face that~          helps keep the head still. A sugar fluid with a radioactive material attached to it is~          injected into a catheter (plastic tube) that has been inserted into a vein in the~          patient's arm. The scanner detects ...~   "
262530|NCT00113009|"~     This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which~     subjects with intermittent claudication (IC) will be randomized to receive a single treatment~     of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline)~     administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower~     extremities during one procedure to evaluate the safety, tolerability, and potential activity~     of VLTS-934 as compared with a saline placebo.~   "
262531|NCT00112996|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs,~     such as alpha-lipoic acid, may protect normal cells from the side effects of chemotherapy.~     Alpha-lipoic acid may also prevent damage to nerves that carry information to and from the~     brain and spinal cord to the rest of the body. It is not known whether alpha-lipoic acid is~     more effective than placebo in preventing peripheral neuropathy.~      PURPOSE: This randomized phase III trial is studying alpha-lipoic acid to see how well it~     works compared to placebo in preventing peripheral neuropathy in patients receiving~     chemotherapy for cancer.~   "
262532|NCT00112983|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of eculizumab may prevent leukemia and stop the destruction of red~     blood cells in patients with paroxysmal nocturnal hemoglobinuria.~      PURPOSE: This randomized phase III trial is studying how well eculizumab works in treating~     patients with paroxysmal nocturnal hemoglobinuria.~   "
262533|NCT00112957|"~     This was a Phase 2, single-center, open-label study of recombinant vaccinia-NY-ESO-1~     (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) injections in patients who had a~     complete response to standard therapy for epithelial ovarian, fallopian tube, or primary~     peritoneal carcinoma and whose tumors expressed NY-ESO-1 or LAGE-1 antigen. Study objectives~     were to evaluate maintenance of remission at 12 months, time to failure of vaccine therapy,~     cellular and humoral immunity and any correlation with time to failure, and safety.~   "
262606|NCT00111904|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with~     unresectable locally advanced or metastatic pancreatic cancer.~   "
262535|NCT00112918|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as bevacizumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Bevacizumab (Bv) may also stop the growth of tumor cells by~     blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab~     after surgery may kill any tumor cells that remain after surgery. It is not yet known whether~     giving combination chemotherapy together with bevacizumab is more effective than combination~     chemotherapy alone in treating colon cancer in adjuvant setting.~      PURPOSE: This randomized phase III trial is studying two different combination chemotherapy~     regimens with or without bevacizumab to compare how well they work in treating patients who~     have undergone surgery for high risk stage II or stage III colon cancer.~   "
262536|NCT00112905|"~     This phase II trial is studying how well sorafenib works in treating patients with~     progressive regional or metastatic cancer of the urothelium. Sorafenib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow~     to the tumor.~   "
262537|NCT00112892|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Selenium may allow higher doses of irinotecan to be given. Giving irinotecan together with~     selenium may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of selenium when given~     together with irinotecan in treating patients with advanced solid tumors.~   "
262538|NCT00112879|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood~     flow to the cancer. Giving arsenic trioxide together with ascorbic acid, dexamethasone, and~     thalidomide may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with~     ascorbic acid, dexamethasone, and thalidomide work in treating patients with multiple~     myeloma.~   "
262539|NCT00112866|"~     Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the~     tumor. Giving cilengitide before and after surgery may be an effective treatment for~     glioblastoma multiforme. This phase II trial is studying how well cilengitide works in~     treating patients who are undergoing surgery for recurrent or progressive glioblastoma~     multiforme.~   "
262540|NCT00112853|"~     This phase I trial is studying the side effects and best dose of tipifarnib and etoposide in~     treating older patients with newly diagnosed acute myeloid leukemia. Tipifarnib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving tipifarnib together~     with etoposide may kill more cancer cells~   "
262541|NCT00112840|"~     This phase I/II trial is studying the side effects and best dose of CCI-779 and bevacizumab~     and to see how well they work in treating patients with metastatic or unresectable kidney~     cancer. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     find tumor cells and kill them or carry tumor-killing substances to them. Others interfere~     with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of~     kidney cancer by blocking blood flow to the tumor. Giving CCI-779 together with bevacizumab~     may kill more tumor cells.~   "
262542|NCT00112827|"~     RATIONALE: Melphalan, a chemotherapeutic agent, has been found to be an effective treatment~     choice for destroying myeloma cells, especially when given at high (bone marrow ablative)~     doses. Total marrow irradiation (TMI)/ablative dose radiation therapy is another modality~     capable of destroying myeloma cells. Autologous peripheral blood/stem cell transplant (ASCT)~     given after either melphalan or following TMI (aimed at the bone marrow containing areas of~     the skeleton, the site of origin of myeloma cells) will shorten the duration/alleviate the~     severity of both melphalan and marrow irradiation-associated side effects. Lenalidomide, an~     effective agent on its own right for the treatment of myeloma, has been shown to further~     enhance the beneficial effects of autologous stem cell transplants when given as maintenance~     therapy.~      PURPOSE: This previously phase I trial established the maximum tolerated dose of TMI at 1600~     cGy. The phase II part of this study is ongoing and is studying the effects of high-dose~     melphalan and ASCT, followed by TMI and a second ASCT, with subsequent maintenance~     lenalidomide. The study is conducted in patients with stages I-III myeloma, with specific~     emphasis on assessing complete and very good partial response rate conversions,~     progression-free and overall survival, and safety/feasibility of delivering the planned~     treatment regimen.~   "
262543|NCT00112775|"~     RATIONALE: BMS-354825 and imatinib mesylate may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~      PURPOSE: This randomized phase II trial is studying BMS-354825 to see how well it works~     compared to imatinib mesylate in treating patients with chronic phase chronic myelogenous~     leukemia that did not respond to previous imatinib mesylate.~   "
262544|NCT00112749|"~     RATIONALE: Infliximab may help improve energy levels in patients who have undergone treatment~     for breast cancer.~      PURPOSE: This phase II trial is studying how well infliximab works in treating cancer-related~     fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage~     II breast cancer.~   "
262545|NCT00112736|"~     Erlotinib and temsirolimus and may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. This phase I/II trial is studying the side effects and best~     dose of temsirolimus when given together with erlotinib and to see how well they work in~     treating patients with recurrent malignant glioma.~   "
262546|NCT00112723|"~     This phase I/II trial is studying the side effects and best dose of flavopiridol and to see~     how well it works in treating patients with lymphoma or multiple myeloma. Drugs used in~     chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing.~   "
262607|NCT00111891|"~     This is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach~     to treating dyslipidemia.~   "
262547|NCT00112710|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is~     more effective than giving gemcitabine together with carboplatin in treating non-small cell~     lung cancer.~      PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how~     well they work compared to gemcitabine and carboplatin in treating patients with stage III or~     stage IV non-small cell lung cancer.~   "
262548|NCT00112697|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet~     known whether radiation therapy, docetaxel, and fluorouracil are more effective than~     radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic~     cancer.~      PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and~     fluorouracil to see how well they work as first-line therapy compared to radiation therapy,~     docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot~     be removed by surgery.~   "
262549|NCT00112684|"~     This phase I trial is studying the side effects and best dose of alvocidib in treating~     patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such~     as alvocidib, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Alvocidib may also stimulate the immune system in~     different ways and stop tumor cells from growing. It may also stop the growth of solid tumors~     by blocking blood flow to the tumor.~   "
262550|NCT00112671|"~     This phase II trial is studying how well sorafenib works in treating patients with advanced~     or metastatic cancer of the urinary tract. Sorafenib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
262551|NCT00112658|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. It is not yet known which~     chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.~      PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy~     works as first-line therapy in treating patients with metastatic pancreatic cancer.~   "
262552|NCT00112645|"~     RATIONALE: A peripheral stem cell, bone marrow, or umbilical cord blood transplant may be~     able to replace blood-forming cells that were destroyed by chemotherapy and radiation~     therapy. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells. Giving busulfan and melphalan with or without antithymocyte globulin~     before transplant and cyclosporine with methylprednisolone or methotrexate after transplant~     may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in~     treating young patients with relapsed or refractory solid tumors.~   "
262553|NCT00112632|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor~     so that it can be removed.~      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating~     patients with locally advanced gastrointestinal stromal tumor.~   "
262554|NCT00112619|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of~     topotecan when given by intraventricular infusion in treating young patients with neoplastic~     meningitis due to leukemia, lymphoma, or solid tumors.~   "
262555|NCT00112593|"~     This clinical trial studies the side effects and best dose of giving fludarabine and~     total-body irradiation (TBI) together followed by a donor stem cell transplant and~     cyclosporine and mycophenolate mofetil in treating human immunodeficiency virus~     (HIV)-positive patients with or without cancer. Giving low doses of chemotherapy, such as~     fludarabine, and TBI before a donor bone marrow or peripheral blood stem cell transplant~     helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system~     from rejecting the donor's stem cells. The donated stem cells may replace the patient's~     immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).~     Sometimes the transplanted cells from a donor can also make an immune response against the~     body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after the~     transplant may stop this from happening.~   "
262556|NCT00112580|"~     RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in~     different ways and stop tumor cells from growing.~      PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with~     stage IV pancreatic cancer that cannot be removed by surgery.~   "
262557|NCT00112567|"~     RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy~     cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem~     cells from a donor whose blood closely resembles the patient's blood will help the patient's~     bone marrow make new stem cells that become red blood cells, white blood cells, and~     platelets.~      PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation,~     fludarabine, and thiotepa and to see how well they work in treating young patients who are~     undergoing a donor stem cell transplant for hematologic cancer.~   "
262558|NCT00112554|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well~     they work compared to cytarabine alone in treating patients with relapsed acute myeloid~     leukemia.~   "
262608|NCT00111878|"~     The primary objective of this study is to describe the safety and tolerability of a single~     dose of MEDI-534 when administered to healthy adult volunteers.~   "
262866|NCT00108381|"~     This clinical trial compares two psychological treatments for back pain.~   "
262559|NCT00112528|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab~     together with gemcitabine and oxaliplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with~     gemcitabine and oxaliplatin works in treating patients with metastatic pancreatic cancer.~   "
262560|NCT00112515|"~     RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with~     cancer.~      PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in~     patients with cancer.~   "
262561|NCT00112502|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Thalidomide may stop the growth of glioblastoma multiforme by blocking blood flow to the~     tumor. Isotretinoin may help cells that are involved in the body's immune response to work~     better. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. It is not yet known which temozolomide-containing regimen is more effective~     in treating glioblastoma multiforme.~      PURPOSE: This randomized phase II trial is studying eight different temozolomide-containing~     regimens to compare how well they work in treating patients who have undergone radiation~     therapy for glioblastoma multiforme.~   "
262562|NCT00112489|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin~     works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.~   "
262563|NCT00112476|"~     This phase I trial is studying the side effects and best dose of temsirolimus when given~     together with bryostatin 1 in treating patients with unresectable or metastatic solid tumors.~     Drugs used in chemotherapy, such as temsirolimus and bryostatin 1, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~   "
262564|NCT00112463|"~     This phase II trial studies how well depsipeptide (romidepsin) works in treating patients~     with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as~     depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~   "
262565|NCT00112437|"~     This is a 1-year base study with a 1-year extension to examine the effects of a new~     experimental medication (odanacatib [MK-0822]) on postmenopausal osteoporosis. This study~     will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different~     doses of odanacatib or to placebo. Measurements performed during the study include: bone~     mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements~     and optional bone biopsies (at the end of 2 years).~   "
262566|NCT00112424|"~     This study is a prospective, randomized study of patients with single ventricle heart disease~     who are to undergo superior cavo-pulmonary anastomosis, or Glenn operation. Such patients~     have historically undergone cardiac catheterization to ensure suitability for the procedure.~     Cardiac magnetic resonance imaging (cardiac MRI) is a newer technology that provides~     excellent anatomic and functional imaging of the heart. This study is designed to demonstrate~     our hypothesis that cardiac magnetic resonance imaging will provide comparable information to~     catheterization, with less side effects.~   "
262567|NCT00112411|"~     This study is designed to evaluate the single-dose effectiveness of two bronchodilator~     inhalers given at two dose levels in pediatric asthma patients.~   "
262568|NCT00112398|"~     The study hypothesis is that advanced interventions as provided by a physician at an accident~     scene will decrease the death rate and the rate of severe disability in survivors of severe~     head injury. Extended interventions by advanced level prehospital providers may include rapid~     sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.~   "
262569|NCT00112385|"~     The purpose of the study is to obtain preliminary data regarding the safety and tolerability~     of etanercept in DM. In addition, we will use the study to assess the variability,~     reliability, and responsiveness of the core set of outcome measures recommended by IMACS. The~     study will be performed under the aegis of the Muscle Study Group (MSG), consisting of~     experienced investigators with an avid interest in myopathies. The ultimate goal of this~     pilot study will be to obtain necessary, prerequisite information important in designing~     future therapeutic trials of etanercept and other agents in patients with DM. The specific~     aims of the study are:~      Aim 1: To preliminarily assess the safety and tolerability of etanercept in patients with DM.~      Aim 2: To assess the safety and tolerability of prednisone in the dosing schedule we propose~     to use.~      Aim 3: To evaluate outcome measures recommended by IMACS and assess their variability,~     reliability, and responsiveness in order to facilitate the design of future therapeutic~     trials in the inflammatory myopathies.~   "
262570|NCT00112372|"~     The primary objective of this current phase I trial is to study the safety and tolerability~     of an orally administered dosage form of ridaforolimus. This will be accomplished by an~     ascending dose study of several dosage regimens in patients with advanced malignancies.~   "
262571|NCT00112359|"~     The purpose of this study was to evaluate the safety and efficacy of a 28-day course of~     aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung~     infection due to Pseudomonas aeruginosa (PA).~   "
262572|NCT00112346|"~     The primary purpose of this study is to estimate the number of patients with non-small cell~     lung cancer whose tumor responds to the treatments given in this study.~   "
262583|NCT00112203|"~     Itopride is a compound already marketed in Japan and in some countries of Eastern Europe~     under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients~     suffering from this condition have difficulties digesting food. Patients feel full after~     eating; they have bloating and have stomach pain. The goal of this study is to see if~     itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.~   "
262573|NCT00112333|"~     The purpose of the study is to use functional Magnetic Resonance Imaging (MRI) to help us~     understand what parts of the subject's brain are involved when he experiences visceral pain,~     or pain in the gut. To stimulate the brain, he will be infused with a liquid meal (Ensure)~     into his stomach until he is maximally full. Magnetic resonance imaging (MRI) is a technique~     for making images (pictures) of the brain; it uses magnetic fields and radio waves and is not~     harmful. This study uses a new investigational technique called functional MRI (fMRI), which~     is a very fast MRI technique that will allow the investigators to evaluate changes in how~     blood flows to parts of his brain.~   "
262574|NCT00112320|"~     Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart~     disease, usually involves surgery on the outflow of the right ventricle (RV) and the~     pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This~     procedure often leads to regurgitation (leakage) of the pulmonary valve, which puts the~     burden of handling a larger than normal amount of blood flow on the RV. Over the years, that~     extra burden leads to enlargement of the RV and to a decrease in its function. Treatment~     often includes surgical insertion or replacement of a new pulmonary valve. Replacement of the~     damaged pulmonary valve aims to minimize the leakage and help the RV function better. This~     study is designed to compare two methods of how the operation (called pulmonary valve~     replacement [PVR]) is performed. In the first method, a new valve is inserted and only the~     area of the old valve is operated on; this is the standard PVR. The second method involves~     inserting the new valve in the same way as the standard method but, in addition, areas of the~     right ventricular wall that are scarred and not functioning well are removed (PVR plus right~     ventricular remodeling). This study will evaluate which method is more effective based on the~     size and function of the RV measured by cardiac magnetic resonance imaging (CMR) six months~     following surgery, as compared to its size and function before the operation.~   "
262575|NCT00112307|"~     The primary goal of this pilot study is to assess the feasibility of using magnetic resonance~     (MR) imaging guidance in the Magnetic Resonance Therapy (MRT) unit at the Brigham and Women's~     Hospital during the implantation of brachytherapy applicators in patients with gynecologic~     malignancies. Patients with gynecologic malignancies requiring brachytherapy are currently~     treated under either fluoroscopic or CT visualization of the brachytherapy applicator.~     Magnetic resonance imaging has been shown in many studies to provide superior visualization~     of the cervix, vagina and uterus compared to CT. However no prior study has examined the~     feasibility of using real-time magnetic resonance imaging to assist in the guidance of~     gynecologic brachytherapy applicators~   "
262576|NCT00112294|"~     The primary purpose of this clinical research study is to learn if patients treated with the~     combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free~     survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this~     treatment will also be studied.~   "
262577|NCT00112281|"~     Tilarginine Acetate Injection is a new type of drug that temporarily stops the body from~     making a bodily substance called nitric oxide. The body may produce excess nitric oxide~     following severe heart damage leading to shock. During a heart attack, and especially after a~     blocked artery causing the heart attack is reopened, a large amount of nitric oxide is~     released into the heart muscle and into the blood. Normally small amounts of nitric oxide are~     good for the heart and blood vessels. However, when released in large amounts, such as during~     a heart attack, it may be harmful, by adding to the damage of the heart attack and lowering~     the heart’s ability to pump blood to the body. It may cause blood pressure to be lowered and~     reduce the amount of blood flow to the body’s vital organs. This may interfere with the~     body’s organs being able to do their work. If Tilarginine Acetate Injection can stop extra~     nitric oxide from being made, the performance of the heart and blood flow to the organs may~     get better, which may result in the improvement of symptoms. The purpose of this study~     (TRIUMPH) is to investigate the safety and effectiveness of Tilarginine Acetate Injection~     compared to placebo (an inactive fluid that has no effect on the body but looks exactly like~     the medication being studied). The study will help determine whether Tilarginine Acetate~     Injection, by temporarily lowering the amount of nitric oxide released into the vital organs~     can improve blood pressure and the blood flow to the body’s organs.~   "
262578|NCT00112268|"~     Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist,~     Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital~     sign intervention with (2) fax referral of preparation-stage patients for telephone~     counseling and (3) feedback to the provider. The question will be examined in a randomized~     trial, with practices as the unit of analysis and with a control intervention consisting of a~     conventional vital sign intervention. The experiment will therefore compare what intervention~     and control practices accomplish beyond simply identifying patients who use tobacco.~      Secondary: To assess contextual factors that might affect implementation of the intervention~     and account for its ultimate success or failure. In particular, to assess: (1) environmental~     and practice-level factors that affect practices’ ability to successfully implement and use~     the intervention and; (2) patient characteristics beyond readiness to change (i.e., age,~     gender, race/ethnicity) that affect willingness to use the quit line and complete counseling.~   "
262579|NCT00112255|"~     The purpose of this study was to compare the effectiveness of partner notification by general~     practice nurses with referral to a specialist clinic for people with genital chlamydia~     diagnosed in a community setting. We hypothesised that referral to a specialist would be more~     effective in ensuring treatment of the sexual partners of infected people than the simpler~     nurse-led strategy.~   "
262580|NCT00112242|"~     The purpose of this study is to determine whether vaccination with melanoma antigen peptides~     [Melan-A/Mart-1 (both EAA and ELA), NY-ESO-1b analog, Long NY-ESO-1 LP and MAGE-A10] and~     Montanide, CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma~     patients and to assess the safety of this vaccination.~   "
262581|NCT00112229|"~     The purpose of this study is to determine whether vaccination with tumor antigenic peptides~     and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and~     to assess the safety of this vaccination.~   "
262582|NCT00112216|"~     The purpose of this study is to test whether vaccination with antigenic peptides induces an~     immune response in the vaccine site sentinel lymph node of patients with microscopically~     detectable lymph node melanoma metastases.~   "
262584|NCT00112190|"~     Itopride is a new compound that is already marketed in Japan and in some countries of Eastern~     Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia.~     Patients suffering from this condition have difficulties digesting food. They feel full after~     eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to~     see if itopride helps to relieve the symptoms of functional dyspepsia.~   "
262585|NCT00112177|"~     Itopride is a new compound that is already marketed in Japan and in some countries of Eastern~     Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia.~     Patients suffering from this condition have difficulties digesting food. They feel full after~     eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to~     see if itopride helps to relieve the symptoms of functional dyspepsia.~   "
262586|NCT00112164|"~     The purpose of this study is to test the efficacy of activated Protein C (Xigris) for~     improving clinical outcomes in individuals with acute lung injury (ALI).~   "
262587|NCT00112151|"~     The purpose of this study is to evaluate the effects of testosterone supplementation~     (AndroGel) on body composition, strength, endurance, cognition, and function in older men.~   "
262588|NCT00112138|"~     The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared~     to placebo in the treatment of hot flashes in postmenopausal women using a phase III~     randomized controlled trial.~   "
262589|NCT00112125|"~     The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe~     and effective in patients with moderate to severe heart failure symptoms.~   "
262590|NCT00112112|"~     The main purpose of this study is to get information about the safety of a flu vaccine spray,~     called FluMist, in children with cancer. The study is also being done to find out how much~     and how long the vaccine spray can be found in the nose.~   "
262591|NCT00112099|"~     The purpose of this study is to evaluate the role of splenectomy in potentially curative~     total gastrectomy for proximal gastric carcinoma in terms of survival benefit and~     post-operative morbidity.~   "
262592|NCT00112086|"~     A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive~     surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as~     ovarian, tubal and peritoneal carcinomas.~   "
262593|NCT00112073|"~     The purpose of this study is to assess the safety and tolerability of multiple doses of~     AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).~   "
262594|NCT00112060|"~     This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of~     PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy~     in subjects with NSCLC.~   "
262595|NCT00112047|"~     The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified~     antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1~     (HIV-1) infected participants. The primary objective of the study was to assess~     noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF)~     in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in the~     treatment of HIV-1 infected ART-naive participants, determined by the achievement and~     maintenance of confirmed HIV-1 ribonucleic acid (RNA) < 400 copies/mL (c/mL) through Week 48,~     as defined by the United States (US) Food and Drug Administration (FDA)~     time-to-loss-of-virologic-response (TLOVR) algorithm.~   "
262596|NCT00112034|"~     The purpose of this study is to determine the efficacy and safety of combination therapy with~     AVONEX plus low dose oral methotrexate (MTX), every other month courses of intravenous~     methylprednisolone (IVMP), or both in patients with continued disease activity on AVONEX~     monotherapy.~   "
262597|NCT00112021|"~     This is a study to examine the effect of pramlintide on body weight and its safety and~     tolerability in obese subjects.~   "
262598|NCT00112008|"~     The proposed study is designed to test a novel dosing paradigm that would facilitate the~     treatment of anemia in CKD patients not on dialysis. Anemic patients who are not currently~     receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.~   "
262599|NCT00111995|"~     This study is designed to evaluate the hemoglobin response to Aranesp® (darbepoetin alfa) in~     black subjects (African-Americans) with chronic renal failure (CRF) receiving hemodialysis~     and to examine the safety profile.~   "
262600|NCT00111982|"~     The purpose of this study is to determine long-term efficacy of continuous IPu liatermin~     infusion administered with concomitant standard anti-Parkinsonian therapy.~   "
262601|NCT00111969|"~     The purpose of this study is to test the safety and efficacy of the Celacade™ system in~     reducing the risk of mortality and cardiovascular hospitalizations in patients with chronic~     systolic heart failure.~   "
262602|NCT00111956|"~     Metabolic syndrome is associated with increased inflammatory cytokines and reduced~     adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned~     that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin,~     improving the inflammatory milieu associated with metabolic syndrome.~   "
262603|NCT00111943|"~     The purpose of this study is to determine the safety and acceptability of a vaginal~     microbicide in HIV uninfected sexually active women.~      Study hypothesis: The vaginal microbicide 1% tenofovir will be safe and well tolerated in HIV~     uninfected women who are in good general health.~   "
262604|NCT00111930|"~     The purpose of the study is to examine whether DHEA replacement therapy is associated with~     beneficial changes in body composition (i.e., increases in lean mass and bone mass, and~     decreases in fat mass).~   "
262605|NCT00111917|"~     The goal of this research study is to test the clinical effectiveness of a drug called~     infliximab (Remicade) in chronic beryllium disease (CBD). This drug may reduce tumor necrosis~     factor-alpha (TNF-a), which is associated with more severe disease and inflammation in the~     lung. Receiving infliximab may help with symptoms, and may improve clinical testing data~     normally ordered by your doctor, such as breathing tests. Baseline and follow-up testing will~     look for improvements in breathing tests (pulmonary function testing), exchange of oxygen in~     the lungs (exercise test), chest x ray, and lung inflammation.~   "
262631|NCT00111579|"~     The purpose of this study is to describe the level of serum antibody conferred by CAIV-T and~     TIV against homotypic and heterotypic influenza virus strains.~   "
262609|NCT00111865|"~     Objectives: The primary objective of this trial is to determine the effect of aerobic~     exercise training (AET) on change in quality of life (QoL) in lymphoma survivors receiving~     and not receiving chemotherapy. Secondary objectives are to determine the effects of AET on~     changes in psychosocial outcomes, cardiopulmonary fitness, body composition, and treatment~     completion rates.~   "
262610|NCT00111852|"~     The purpose of this study is to evaluate desmoteplase (which is a manufactured protein~     derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of~     blood through one (or more) of the blood vessels supplying the brain, thereby reopening the~     blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic~     stroke.~   "
262611|NCT00111839|"~     This open-label, multicenter, randomized, controlled, Phase II study is planned to answer~     questions about how the drug, matuzumab (EMD 72000), works and is part of an effort aimed to~     develop better treatment for advanced lung cancer by combining matuzumab, a monoclonal~     antibody, with a chemotherapy treatment, called pemetrexed.~   "
262612|NCT00111826|"~     The purpose of this study is to assess the effects of the Celacade™ system in patients with~     intermittent claudication.~   "
262613|NCT00111813|"~     The purposes of this study are:~        -  To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and~          bortezomib in participants with advanced multiple myeloma~        -  To assess the safety and tolerability of this regimen and to document the participant's~          clinical status (by anti-tumor activity) for this combination, as determined per~          standard of care.~   "
262614|NCT00111800|"~     This is a 24-week study investigating the safety and efficacy of several dosages of a~     potential new oral medicine for Type II diabetes mellitus.~   "
262615|NCT00111787|"~     This Study was designed to determine how effective and safe a new investigational drug,~     lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed~     inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of~     treatment and at the time of surgical resection will be examined for pathologic response and~     biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of~     14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib~     and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and~     physical exams will be performed throughout the study to monitor safety.~   "
262616|NCT00111774|"~     The purpose of this study is to determine if ABX-EGF is safe and efficacious in patients with~     metastatic colorectal cancer.~   "
262617|NCT00111761|"~     The purpose of this study is to determine if panitumumab, in combination with irinotecan,~     leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic~     colorectal cancer.~   "
262618|NCT00111748|"~     The main goal of this study is to evaluate the effectiveness of the combination of these~     drugs, and whether they can be given safely together.~   "
262619|NCT00111735|"~     The aim of the study is to examine the effects of fine titration of thyroxine dosage on~     symptoms of hypothyroidism, wellbeing and quality of life. The hypothesis is that symptoms of~     hypothyroidism, wellbeing and quality of life will be improved in thyroxine-treated subjects~     when serum thyrotropin (TSH) is suppressed and/or in the lower reference range, compared to~     when TSH is in the upper reference range.~   "
262620|NCT00111722|"~     The purpose of this study is to test the effectiveness of a marketed drug in the treatment of~     a menstrual migraine attack.~   "
262621|NCT00111709|"~     The purpose of this study is to test the effectiveness of a marketed drug in the treatment of~     a menstrual migraine attack.~   "
262622|NCT00111696|"~     To describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant~     melanoma.~   "
262623|NCT00111683|"~     In this study participants with relapsed/refractory leukemia will be given MK-0457 in~     sequential cohorts and with varying treatment duration to determine the maximum tolerated~     dose (MTD) for MK-0457.~   "
262624|NCT00111670|"~     This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to~     placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3~     months and the target sample size is 100-500 individuals.~   "
262625|NCT00111657|"~     The purpose of this study is to determine whether PEG-uricase (a chemically modified~     recombinant mammalian enzyme that degrades uric acid) is effective in controlling~     hyperuricemia in patients with chronic gout, who cannot tolerate, or have not responded~     adequately, to conventional therapy for gout.~      Funding Source - FDA OOPD~   "
262626|NCT00111644|"~     This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with~     ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by~     Legionella. The anticipated time on study treatment is 3-12 months and the target sample size~     is 100-500 individuals.~   "
262627|NCT00111631|"~     This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients~     with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study~     treatment is 3-12 months and the target sample size is 100-500 individuals.~   "
262628|NCT00111618|"~     The purpose of this trial is to confirm a safe dose of AS1404, to be given with docetaxel,~     and to see whether adding AS1404 and docetaxel together improves the outcome of the~     treatment, when compared to docetaxel alone.~   "
262629|NCT00111605|"~     The purpose of this study is to evaluate the safety and tolerability of an experimental HIV~     vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating~     doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a~     vaccine. This study will also determine the safety and tolerability of an experimental HIV~     vaccine boosted with two adjuvants.~   "
262630|NCT00111592|"~     Ageing and the availability of medication has led to an increase of elderly male patients~     being treated for lower urinary tract symptoms (LUTS), or voiding problems (prostate~     problems). However, guidelines are vague as to which patients should and which should not be~     treated, and how.~      Although several treatment modalities have proven efficacy in selected populations, it is~     unclear how effective these treatments are in daily practice.~      This study investigates the hypothesis that a treatment protocol in which clear indications~     are formulated for all treatment modalities is more effective, as compared to current usual~     primary care, in reducing both symptoms as related to the quality of voiding in elderly~     males.~   "
262634|NCT00111540|"~     This open label study is designed to assess long term glucose control, as measured by~     hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with~     type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a~     day.~   "
262635|NCT00111527|"~     A suboptimal level of resynchronization (cardiac resynchronization therapy [CRT]) achieved in~     many patients with actual standards and techniques based on tissue-Doppler echocardiography~     could be more effective to obtain better CRT results. Eligible patients who successfully~     received atrioventricular (AV) junction ablation and biventricular (BiV) pacing are~     randomised to a comparison between a strategy of right ventricular (RV) apical pacing with~     delayed CRT based on clinical indications with a strategy of early optimal CRT based on an~     echocardiographic stratification.~      End-points:~        -  Acute echo comparison (acute echo study)~        -  Quality of life and exercise tolerance (Short-term clinical study)~        -  Composite end-point of CRT clinical failure (Long-term clinical study)~   "
262636|NCT00111514|"~     The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given~     as three injections every 28 days at each of three dose levels of Leish-111f protein, in~     combination with standard pentavalent antimony therapy in adult patients with mucosal~     leishmaniasis.~   "
262637|NCT00111501|"~     The overall goals of this line of research are to develop and evaluate innovative treatments~     for lesbian, gay, bisexual, and transgender (LGBT) cigarette smokers and to understand the~     processes related to smoking and relapse in this previously unstudied population of smokers.~     In this study, participants are randomly assigned to one of two Internet-based smoking~     cessation treatments: 1) a self-help intervention tailored LGBT smokers plus social support~     plus email-based counseling, or 2) a standard self-help condition alone, similar to other~     general smoking cessation treatments. Before starting the program, participants will complete~     measures of smoking, nicotine dependence, depression diagnosis, demographics, mood,~     motivation to change, and alcohol use. Smoking status will be determined at 1, 3, 6, and 12~     months following the start of treatment. Data will be analyzed to compare the quit rates of~     the two Internet-based treatment groups. Also, we will complete exploratory analyses to~     determine those variables that best predict quitting for LGBT smokers.~   "
262638|NCT00111488|"~     The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the~     Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and~     effectiveness of the Guidant FLEX® Microwave Surgical Ablation System in the treatment of~     permanent atrial fibrillation (AF).~   "
262639|NCT00111475|"~     The purposes of this study are: to determine a weekly dose that demonstrates a satisfactory~     safety profile and sustains elevated platelet counts within a targeted therapeutic level (a~     doubling of baseline platelet counts and within the range of greater than or equal to 50 x~     10^9/L and less than or equal to 450 x 10^9/L in thrombocytopenic subjects with ITP; to~     assess Amgen megakaryopoiesis protein 2 [AMP2 (AMG 531)] pharmacokinetics (PK) in~     thrombocytopenic subjects with ITP.~   "
262640|NCT00111462|"~     The purpose of this study is to compare the effect of darbepoetin alfa administered in a~     weight based versus fixed dosing for the treatment of anemia in subjects with non-myeloid~     malignancies receiving multicycle chemotherapy.~   "
262641|NCT00111449|"~     The purpose of this study is to determine the effect of etanercept 50 mg twice weekly~     compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects~     with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg~     twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported~     outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice~     weekly.~   "
262642|NCT00111436|"~     The purpose of this study is to evaluate the safety and tolerability of long-term~     administration of etanercept in adults with psoriasis who have participated in previous~     etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy~     of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis~     studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly~     (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72~     weeks.~   "
262643|NCT00111423|"~     The purpose of this study is to evaluate the safety of an additional 28 weeks of treatment~     with pegsunercept for subjects who have completed treatment in a previous double-blind study~     (20000201 or 20000198). In addition, this study will evaluate the efficacy and the~     feasibility of subject self-administration on an outpatient basis.~   "
262644|NCT00111410|"~     The purpose of this study is to estimate the effect of anakinra, 100 mg once daily (QD), on~     the development of an anti-tetanus antibody response in subjects with RA after vaccination~     with a tetanus and diphtheria toxoids injection. In addition, this study will evaluate the~     general safety profile of therapy with anakinra, 100 mg QD, in subjects with RA after~     vaccination with a tetanus and diphtheria toxoids injection.~   "
262645|NCT00111397|"~     Mycobacterium avium complex (MAC) are ubiquitous organisms that cause isolated pulmonary~     disease in otherwise healthy patients with yet undefined susceptibilities. Patients typically~     present with a history of chronic cough, eventually progressing to hemoptysis, fever, and~     hypoxia. With half or more of all patients failing standard three-drug therapy, this is an~     insidious disease with a poor prognosis. Under the natural history protocol of nontuberculous~     mycobacterial infection (NTM; #01-I-0202), 46 patients with diagnosed pulmonary MAC disease~     are being studied. Numerous studies have suggested that a dysregulation in cytokine~     production may make these patients susceptible to mycobacterial infection. Cytokines are~     particularly important in the activaction of macrophages, which help to clear mycobacterial~     infection. Interferon gamma 1b (Actimmune) and GM-CSF (Leukine) are two cytokine therapies~     that have been approved in the treatment of chronic granulomatous disease and~     post-transplantation hematopoietic reconstitution, respectively. A number of in vitro studies~     suggest that either or both of these therapies may help to clear MAC infection. Given the~     poor outcomes of therapy and the persistent, debilitating nature of the disease, new~     therapies are desperately needed, and many are being tried without benefit of scientific~     foundation. Currently, there are no prospective trials that show any effect of these drugs in~     the lung delivered subcutaneously. This protocol proposes to perform a pilot study to~     evaluate the effects, if any, of these macrophage stimulating cytokines in the context of~     ongoing pulmonary MAC infection.~      Aims:~      To determine the local and systemic effect, if any, of adjuvant IFN gamma and GM-CSF in~     pulmonary MAC patients.~      Methods:~      Fifteen patients will be randomized into three treatment groups of five patients each. The~     first group will receive a standard drug regimen, based on the 1997 ATS guidelines. The~     second and third groups, in addition to receiving the standard therapy, will also receive~     three months of (IFN{gamma}) and GM-CSF, respectively. All patients will undergo bronchoscopy~     with bronchoalveolar lavage (BAL) at the beginning of the study, after three months, and at~     six months.~      In addition to obtaining traditional subjective and objective clinical measures, both~     proteomic and genomic analysis of the BAL will be performed to determine if cytokine therapy~     effects any detectable change in the lungs. In vitro studies on typ...~   "
262646|NCT00111384|"~     This study may identify genes that predict the seriousness of neurofibromatosis type 1 (NF1).~     Finding these genes may explain why some people with NF1 have more medical problems than~     others. The study will also examine medical problems in NF1 that are rarely seen and are not~     well understood.~      Male and female patients with NF1 who have gone through puberty may be eligible for this~     study, as well as patients of any age who have unique or under-recognized disease features.~     Affected and unaffected family members, including parents, siblings, and more distant~     relatives, may also be enrolled. Candidates are screened with a discussion of medical history~     or review of medical records, or both. Participants undergo the following procedures:~      Patients with NF1~        -  Physical examination and family history~        -  Photographs of the iris of each eye~        -  Photographs of the back, abdomen and thigh to count skin tumors~        -  Photographs of the face and body (with underwear on) to help track growth and appearance~        -  Magnetic resonance imaging (MRI) of the spine (This test uses a magnetic field and radio~          waves to look for tumors and curvature of the spine. The patient lies still in the~          scanner, a narrow cylindrical device, wearing earplugs to muffle loud knocking sounds~          that occur during the scan. A contrast material called gadolinium is injected into a~          vein through a catheter to enhance the images.)~        -  Blood draw for genetic studies~        -  Possibly a skin biopsy (with the use of numbing medicine, removal of a small sample of~          skin tissue) to grow cells in the laboratory~      Patients with NF1 who have unique or under-recognized disease features~        -  Physical examination and family history~        -  Blood draw for genetic studies~        -  Possibly a skin biopsy~        -  Possibly additional tests, such as blood work, x-rays, photographs, MRIs, ultrasounds,~          or other tests~      Unaffected family members~        -  Blood draw for genetic studies~        -  Brief skin and eye examinations~        -  Possibly a skin biopsy for cell culture~      Families are asked to give permission for researchers to recontact them for follow-up~     information, additional blood samples, or follow-up visit.~   "
262647|NCT00111371|"~     This study aims to determine whether levodopa, in combination with a high frequency training~     of (grammatical) rules, is effective in boosting learning success in healthy subjects and~     whether this kind of training in combination with levodopa improves reading and spelling~     abilities of patients with dyslexia.~   "
262648|NCT00111358|"~     This study is designed to determine the effects of an intensive lifestyle modification~     program in patients with HIV and Metabolic Syndrome. The primary endpoints will be~     improvement in body composition, specifically waist-to-hip ratio (WHR). The secondary~     endpoints will include improvement of cardiovascular indices, such as total cholesterol,~     low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride cholesterol~     levels, blood pressure, cardiac enzymes, c-reactive protein (CRP), tissue plasminogen~     activator (t-PA), plasminogen activator inhibitor (PAI), and insulin and glucose metabolism.~     We expect that quality of life indices and life skills should also improve with the lifestyle~     modification program.~   "
262649|NCT00111345|"~     Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93~     and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In~     spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or~     have even decreased. Against the background that about 40% of the patients still die from~     immediate causes of an underlying disease relapse or of nonresponse, it seems to be~     justifiable to intensify therapy - especially for high-risk patients - which on its parts~     will require an optimization of supportive measures. As the present risk stratification into~     standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the~     risk-adapted therapy strategy.~      The aim of the study is to improve prognosis in children with AML by intensification of~     cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central~     nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.~   "
262650|NCT00111332|"~     Lipodystrophy is characterized by increased cardiovascular disease. Limited strategies are~     available to increase cardiovascular fitness in this population, particularly among women.~     Progressive aerobic and resistance training will increase aerobic capacity and improve~     strength in HIV positive women with lipodystrophy.~   "
262651|NCT00111319|"~     The primary reason for this study is to determine whether the addition of VELCADE~     (bortezomib) for injection to standard melphalan/prednisone (MP) therapy improves the time to~     disease progression (TTP) in subjects with previously untreated multiple myeloma.~   "
262652|NCT00111306|"~     The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard~     treatments for patients with SLE.~   "
262653|NCT00111293|"~     The NIMH is conducting studies aimed at gaining a better understanding of the areas of the~     brain that are involved in different types of mental processes. This study will focus on~     brain regions involved in visual perception and attention.~      Healthy normal volunteers and people who have had a stroke or undergone neurosurgery may be~     eligible for this study. Candidates must be 18 years of age or older, They must not have a~     history of a psychiatric disorder, including depression, anxiety, psychosis, or neurological~     disease other than stroke or the previous neurosurgery.~      Participants undergo the following tests and procedures during four or more visits to the NIH~     Clinical Center:~        -  Physical and neurological examinations and depression rating scale.~        -  Cognitive testing: Subjects complete written tests, sit at a computer and make decisions~          about what they are shown by pressing keys, or answer questions from a test examiner.~        -  Behavioral training: Subjects practice performing a cognitive task that involves looking~          at and making decisions about visual images that appear on a computer screen.~        -  Magnetic resonance imaging (MRI): Subjects undergo MRI scanning while they perform the~          task they previously practiced. The MRI scanner is a metal cylinder surrounded by a~          strong magnetic field. During the procedure, subjects lie still for up to 10 minutes at~          a time on a table that can slide in and out of the cylinder. The entire MRI scanning~          session takes about one hour. There are multiple scans which each can take up to 10~          minutes. They may be asked to return for one or two additional scanning sessions.~      During the behavioral training or MRI scanning, special pieces of equipment that monitor eye~     movements may be used.~      Some subjects may be asked to return to NIH for an additional visit to participate in a~     magnetoencephalographic scan. This test uses several sensors applied to the scalp to measure~     very small changes in magnetic fields. This is another way to measure brain activity.~   "
262654|NCT00111280|"~     This is a Phase II, open-label, roll-over trial to evaluate the long term safety and~     tolerability of TMC125, administered as part of an individually optimized antiretroviral~     therapy, in HIV 1 infected subjects. In addition, the antiviral activity and immunological~     effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV~     phenotype and genotype will be evaluated.~   "
262655|NCT00111267|"~     The purpose of this trial is to study the effects of oral vitamin B12 supplementation and~     vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in~     elderly people with mild vitamin B12 deficiency.~   "
262656|NCT00111254|"~     This research project aims to study the effects of microdermabrasion, a technique causing~     minimal injury used to improve the appearance of fine lines, wrinkles, and scars. Subjects~     will undergo microdermabrasion, which is a gentle sand-blasting of the skin. We are~     interested in determining how this procedure works at rebuilding the skin following~     microdermabrasion.~   "
262675|NCT00110981|"~     The purpose of this study is to evaluate the safety and effectiveness of combination therapy~     with etanercept and narrow-band (NB) UVB phototherapy for the treatment of psoriasis in a~     pilot study. This is a Phase 4 clinical study being conducted under an Amgen Investigational~     New Drug Application (IND).~   "
262657|NCT00111241|"~     Many women with breast cancer are treated with a class of drugs called aromatase inhibitors~     (mainly letrozole or anastrozole), which lowers the amount of estrogen being produced in the~     body. Women on aromatase inhibitors appear to experience joint pains and arthralgia. The aim~     of this study is to determine whether the joint pains experienced by some women on aromatase~     inhibitors is associated with more defects in their cartilage, compared to women not~     receiving this therapy. Using the magnetic resonance imaging (MRI) technique, the knee joint~     will be examined to assess changes in cartilage volume over time.~   "
262658|NCT00111228|"~     The objective of the study is to determine whether patients with poor glycemic control can~     improve metabolic control using the real-time values of the Guardian® RT compared to~     conventional self-monitoring blood glucose finger-sticks.~   "
262659|NCT00111215|"~     The purpose of the study is to determine whether oral contraceptives, desmopressin acetate,~     and/or tranexamic acid are effective in the treatment of women with menorrhagia who are~     diagnosed with a bleeding disorder.~   "
262660|NCT00111202|"~     This research is designed to investigate the perceptions and opinions of individuals who~     either have schizophrenia or who have a family member with schizophrenia, in relation to~     genetic counseling. Data will be collected via a 15 minute online questionnaire. There is~     also an option for respondents to participate in a 45 minute interview if they wish.~      It is expected that the study will show that adequate information about genetic counseling is~     not provided to these individuals. It is also hoped that this research will help to make~     genetic counseling sessions more specific to people with schizophrenia in their family.~   "
262661|NCT00111189|"~     The purpose of this study is to evaluate the efficacy of paliperidone palmitate compared with~     placebo in the prevention of recurrence of the symptoms of schizophrenia and to assess the~     safety and tolerability of paliperidone palmitate in patients with stable and symptomatic~     schizophrenia. The placebo used in this study was a nutritional substance known as 20%~     Intralipid emulsion given to patients requiring intravenous feedings.~   "
262662|NCT00111176|"~     The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA~     [Thoracic Aortic Aneurysm] Endovascular Graft) is a clinical trial approved by the United~     States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith~     TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers.~   "
262663|NCT00111163|"~     The purpose of the study is to see whether antimalarial drugs administered at the time of~     routine infant vaccinations prevents malaria and anemia in the first year of life.~   "
262664|NCT00111150|"~     This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe~     for sexually-active young adults in Botswana without HIV infection and whether it will reduce~     their risk of getting an HIV infection.~   "
262665|NCT00111137|"~     The purpose of this study is to compare the time to hematopoietic response (hemoglobin~     correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for~     subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those~     receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the~     12-week comparative treatment period.~   "
262666|NCT00111124|"~     This study is testing the effect of etanercept in treating both the skin and joint symptoms~     of psoriatic arthritis patients. Enbrel®, also known as etanercept, has already been approved~     by the Federal Food Drug Administration for the treatment of psoriatic arthritis. It is taken~     as an injection under the skin. Participants in the trial will be offered etanercept free of~     charge to be self-injected once weekly for 24 weeks. During that period they will have 5~     appointments at the study center and will also be asked to complete assessments of their~     health.~   "
262667|NCT00111111|"~     The purpose of this multicenter, open-label, prospective study is to evaluate the~     effectiveness and safety of etanercept in the treatment of subjects with psoriasis.~   "
262668|NCT00111098|"~     The proposed study is designed to test a novel dosing paradigm that would facilitate the~     treatment of anemia in CKD patients not on dialysis. Anemic patients who have achieved and~     maintained target hemoglobin (Hb) on every 2 weeks (Q2W) dosing of darbepoetin alfa will have~     the dosing interval extended to once monthly (QM) dosing. Extending the dosing interval for~     darbepoetin alfa to QM represents a major potential benefit to both patients with CKD and~     their caregivers.~   "
262669|NCT00111085|"~     The purpose of the study is to measure how effective and safe three different doses of the~     drug clazosentan are in preventing vasospasm after subarachnoid hemorrhage.~   "
262670|NCT00111059|"~     Cardiovascular risk factors and psycho-social characteristics will be determined in obese and~     non-obese patients in the setting of primary medical care.~   "
262671|NCT00111046|"~     The purpose of this study is to assess post operative pain following the insertion of~     radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or~     tramadol.~   "
262672|NCT00111020|"~     This treatment protocol allows doctors to treat advanced kidney cancer with an~     investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials~     for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial~     in which sorafenib is compared to another equal treatment. All patients in this protocol will~     be treated with sorafenib. In addition, data from the patients who participate in this~     protocol will provide additional information about the drug.~   "
262673|NCT00111007|"~     The objectives of this study are to compare the anti-tumor activity as measured by~     Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel~     and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects~     with unresectable Stage III or Stage IV melanoma who progressed after receiving only one~     prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).~   "
262674|NCT00110994|"~     This is a randomized, double blind, placebo controlled, multicenter, phase II study to~     compare the anti-tumor activity as measured by progression-free survival (PFS) and the~     tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination~     with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not~     received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be~     randomized to receive DTIC + Sorafenib or DTIC + Placebo.~   "
263476|NCT00100048|"~     This is a study that will investigate the safety and efficacy of an investigational drug in~     Human immunodeficiency virus (HIV) infected patients.~   "
262676|NCT00110968|"~     Itopride is a compound already marketed in Japan and in some countries of Eastern Europe~     under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients~     suffering from this condition have difficulties digesting food. Patients feel full after~     eating, they have bloating and have stomach pain. The goal of this study is to see if~     Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.~   "
262677|NCT00110955|"~     The purpose of this study is to compare the effect of darbepoetin alfa against placebo for~     the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle~     chemotherapy.~   "
262678|NCT00110942|"~     The purpose of this study is to evaluate the clinical benefit (change in Western Ontario and~     McMaster University Osteoarthritis Index [WOMAC] pain score) of AMG 108 (300 mg~     subcutaneously [SC] every 4 weeks) in subjects with OA.~   "
262679|NCT00110929|"~     The purpose of this research is to study the efficacy and safety of AMG 073 in patients with~     kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also~     have secondary hyperparathyroidism (HPT).~   "
262680|NCT00110916|"~     The purpose of this study is to evaluate the clinical response in subjects with symptomatic~     OA of the knee following a single 50 mg anakinra, 150 mg anakinra or placebo intra-articular~     (IA) injection.~   "
262681|NCT00110903|"~     The purpose of this study is to assess the safety of etanercept liquid administered once~     weekly to subjects with RA.~   "
262682|NCT00110890|"~     The purpose of this study is to evaluate the ability of a treatment strategy, that includes~     cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid~     hormone (PTH) compared with the standard of care.~   "
262683|NCT00111072|"~     This study will evaluate the effectiveness of dexamethasone 0.01% solution in treating pain~     associated with oral lichen planus, a chronic disease that causes painful ulcers inside the~     mouth. The cause of lichen planus not known, but it may be related to an allergic or immune~     reaction. This study will examine what causes the disease, the pain associated with it, its~     impact on patients' lives and the use of dexamethasone to treat it.~      Patients 12 or older with severe oral lichen planus may be eligible for this study.~     Candidates are screened with blood tests and a biopsy to confirm the diagnosis and provide~     tissues for research purposes. For the biopsy, two small circles of tissue, each about 4 mm~     (1/5 inch) across, are surgically removed.~      Participants are randomly assigned to rinse their mouth with either a dexamethasone solution~     or placebo (a rinse with no active ingredient) four times a day for 4 weeks. During this~     period they may not use any oral or topical pain or anti-inflammatory medications except~     diphenhydramine 12.5 mg/5 ml (a topical numbing medicine) and Tylenol, both which are~     provided by the study.~      Patients come to the NIH Clinical Center for three 1-hour visits (once every two weeks) and~     once more 4 weeks after the study medications are stopped. At the first three visits patients~     submit a pain diary in which they have recorded information on pain levels, and they are~     checked for any medication side effects. On the third visit (the last day they take the study~     drug) they are also tested for adrenal suppression that may have resulted from taking the~     steroid rinse. For this test they are given an injection of a drug called synacthen and after~     1 hour, a blood sample is drawn. Patients return for a final visit 1 month later to determine~     if their disease returns or improves after the medication is stopped.~   "
262684|NCT00110877|"~     Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy,~     safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra~     (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.~   "
262685|NCT00110864|"~     This study is designed to evaluate the safety and efficacy of PN2034 in insulin-dependent~     type 2 diabetics as measured by the change in average daily insulin dose from baseline to~     week 12. The effects of PN2034 on HbA1c, fasting plasma glucose (FPG), and lipid levels will~     also be measured.~   "
262686|NCT00110851|"~     This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2~     diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by~     change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study~     will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose~     (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density~     lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).~   "
262687|NCT00110838|"~     The objective of the SOFA trial is to investigate whether supplemental intake of n-3~     polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of~     life-threatening ventricular arrhythmias in patients with an implantable cardioverter~     defibrillator (ICD).~   "
262688|NCT00110825|"~     Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment~     strategy in promoting longer-term smoking abstinence. We will also conduct secondary analyses~     of mediators and moderators of treatment response.~   "
262689|NCT00110812|"~     The purpose of this study is to determine the effect of short cycles of recombinant~     interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in~     HIV infected patients. The effects will be compared with a study group that receives no IL-2~     or antiretroviral therapy.~      Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to~     patients with early HIV infection, will produce no change in HIV viral load and increases in~     CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.~   "
262690|NCT00110799|"~     SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet~     counts in healthy volunteers. This study is examining several different doses of SB497115 as~     a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential~     candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be~     conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4~     weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who~     successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count~     100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an~     additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.~   "
262708|NCT00110565|"~     The purpose of this study is to determine whether a pulsed magnetic field (PMF) pad will~     improve symptoms of rheumatoid arthritis (RA) in postmenopausal women.~      Study hypothesis: A pulsed magnetic field pad will effectively reduce the symptoms of RA in~     postmenopausal women.~   "
262691|NCT00110786|"~     Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for~     patients with hypersensitivity to ragweed pollen (hay fever). This novel formulation is~     designed to provide a vaccine that will be efficacious with only four escalating dose~     injections administered before the start of the pollen season.~      In this study, the safety and efficacy of Ragweed MATAMPL will be assessed by exposing~     allergic subjects to Ragweed pollen in an environmental exposure chamber (EEC). Patient~     symptomatic response to pollen and patient quality of life in the EEC will be determined.~   "
262692|NCT00110773|"~     Pulsed dye laser (PDL) on the face is painful. For this reason, local anesthesia is commonly~     used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream)~     is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to~     evaluate the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL~     therapy in adults.~   "
262693|NCT00110760|"~     Injection of dermal filler is used as an aesthetic treatment to fill in unwanted wrinkles and~     scars. There can be substantial pain associated with dermal filler injections. For this~     reason, local anesthesia is often used to eliminate or minimize the pain. This anesthesia can~     be administered by injection or through the use of topical creams and ointments.~      S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine~     and tetracaine. The purpose of this study is to evaluate if S-Caine Peel is effective in~     providing topical local dermal anesthesia for dermal filler injections in adults.~   "
262694|NCT00110747|"~     Lasers are used for non-ablative resurfacing of facial rhytides, atrophic scars, and a~     variety of epidermal and dermal lesions. Pain associated with the non-ablative laser~     treatment has been described as moderate to severe. For this reason, local anesthesia is~     commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine~     7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is~     to evaluate if S-Caine Peel is effective in providing topical local dermal anesthesia for~     non-ablative facial laser resurfacing in adults.~   "
262695|NCT00110734|"~     There is pain associated with laser-assisted tattoo removal. For this reason, some form of~     anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a~     topical local anesthetic cream or ointment spread over the skin. The purpose of this study is~     to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream)~     for treating pain during laser-assisted tattoo removal.~   "
262696|NCT00110721|"~     This is a Phase II, multi-center study of GM-CT-01 which has been shown to increase the~     anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly~     used in cancer patients. In this Phase II study, patients with colon cancer which has spread,~     despite treatment with approved therapies, will receive GM-CT-01 plus 5-FU in monthly cycles~     for at least 2 cycles or until their disease progresses.~   "
262697|NCT00110708|"~     The purpose of this study is to determine if human immunoglobulin given by mouth twice a day~     is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea,~     constipation, abdominal pain, and bloating, in children with autism.~   "
262698|NCT00110695|"~     The purpose of this study is to learn how breast cancer tumors respond to a drug called~     Abraxane followed by a combination of 3 chemotherapy drugs commonly used for breast cancer.~   "
262699|NCT00110682|"~     Study Aims:~        -  To compare the long-term efficacy and safety of imiquimod versus vehicle used as an~          adjunct to cryotherapy.~        -  To assess and compare the recurrence rate and time to recurrence of the 2 different~          treatment groups.~      Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses~     (AK) compared to the vehicle arm.~   "
262700|NCT00110669|"~     This study will help to determine whether a high-dose weekly course of prednisone therapy is~     safer than and at least as effective as daily dose therapy for people with Duchenne muscular~     dystrophy (DMD). Boys who are enrolled in this study should not have taken carnitine, other~     amino acids, creatine, glutamine, Coenzyme Q10 or any herbal medicines within the last three~     months. There will be a two-visit screening to take place in one week to ensure a~     reproducible manual muscle test. The subject will then be randomized and put into either the~     daily or weekly regimen. The duration of the study is twelve 28-day treatment cycles~     (approximately 12 months) with follow-up visits at month one, three and then every three~     months.~   "
262701|NCT00110656|"~     The purpose of this study is to collect local laboratory data on immunoreactive parathyroid~     hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR)~     at approximately 1 week, 1 month, 3 months, 6 months and 12 months after the kidney~     transplant.~   "
262702|NCT00110643|"~     The purpose of this research project is to study the effect of non-ablative (non-cutting)~     laser therapy, a technique that uses laser energy to try to improve the appearance of the~     skin. In this study, we are interested in learning how well such a laser works to improve the~     symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser,~     manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.~   "
262703|NCT00110630|"~     The purpose of this study is to determine the efficacy of a 10-week smoking cessation therapy~     combined with NicoDerm CQ for smoking cessation among female prisoners.~   "
262704|NCT00110617|"~     This study will examine the long-term safety and efficacy of Deferasirox in patients with~     sickle cell disease and iron overload from repeated blood transfusions.~   "
262705|NCT00110604|"~     The purpose of this study is to determine if folic acid supplementation can slow down~     atherosclerotic progression, age-related cognitive decline and age-related hearing loss.~   "
262706|NCT00110591|"~     The purpose of the study is to determine the safety and tolerability of PRO 140, an~     investigational anti-HIV drug, administered via intravenous infusion.~      Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans~     and will result in measurable concentrations of the product in serum.~   "
262707|NCT00110578|"~     Effective, suppressive treatment for HIV infected patients can be a major challenge because~     HIV progressively destroys their immune systems. CD8 cells isolated from a patient's blood~     and grown in large numbers in the laboratory may increase a patient's immune system response~     to HIV. The purpose of this study is to determine if CD8 cells will provide effective~     antiviral activity against HIV when transplanted back in large numbers into HIV infected~     patients.~      Study hypothesis: There are specific cells in the immune system that recognize and can kill~     HIV-infected cells.~   "
262709|NCT00110552|"~     The purpose of this study is to determine the effectiveness of the herb sage in improving the~     mental function of individuals with Alzheimer's disease.~      Study hypothesis: The administration of sage will improve cognitive function in patients with~     mild Alzheimer's disease.~   "
262710|NCT00110539|"~     The purpose of this study is to determine the effectiveness of four different strategies~     designed to improve clinicians' knowledge about herbs and dietary supplements. This study~     will also increase their confidence in their ability to answer patient questions about these~     topics.~      Study hypotheses: 1) Delivery of modules over 10 weeks will lead to better educational~     outcomes than delivery of modules at one time. 2) The method of module delivery that directly~     lists the modules in an email will be associated with greater improvements in knowledge,~     confidence, and communication skills and greater satisfaction with the overall curriculum~     than methods that involve the delivery of only links to the modules in an email. 3) Active~     participation in a moderated mailing list will enhance outcomes and satisfaction with the~     curriculum more than non-participation or passive participation (reading the messages of~     others). 4) More positive attitudes toward the use of and greater use of computer and~     Internet technologies at baseline will be associated with more active participation in the~     mailing list; greater use of the modules delivered through links; greater improvements in~     knowledge, confidence, and communication; and more positive attitudes about the curriculum~     following participation in the study.~   "
262711|NCT00110526|"~     The purpose of this research study is to test a new treatment for prostate cancer. We have~     been exploring the use of cytokine (immune stimulating) gene therapy by directly injecting a~     virus which produces a cytokine called interleukin-12 (IL-12) into the prostate gland to~     control tumor growth. We propose to explore the use of adenovirus-mediated human~     interleukin-12 (Ad.hIL-12) in patients with recurrent non-metastatic prostate cancer~     following radiation therapy in a Phase I trial. Participants will be placed in rising dose~     groups with the primary endpoint of learning the maximum dose that can safely be given by~     injection directly into the prostate gland. Toxicity will be determined through physical~     examination, laboratory values, and blood levels of cytokines. Evidence of an immune response~     against prostate proteins will also be monitored. If the treatment works, the cancer will~     shrink or not grow. This will be monitored by prostate specific antigen (PSA) levels in the~     blood. However, we do not know if this treatment will be effective. If the PSA continues to~     rise after treatment, participants will be taken off study and offered other treatment. There~     is no compensation for participation in this research study. There will be no charge for the~     treatment with gene therapy or the monitoring associated with this research study. Monitoring~     will occur in a specially designated clinical research center.~   "
262712|NCT00110513|"~     Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis~     and pulmonary embolism, particularly during certain high risk procedures. The trial focused~     on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical~     procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study~     assessed the incidence of thromboembolic events following prophylactic intravenous~     administration of recombinant human antithrombin (rhAT) to patients with hereditary~     antithrombin (AT) deficiency in situations usually associated with a high risk for~     thromboembolic events.~   "
262713|NCT00110500|"~     The purpose of this study is to evaluate the clinical and laboratory safety of SB-509 when~     given as a single treatment by an intramuscular injection to subjects with diabetic~     neuropathy.~   "
262714|NCT00110487|"~     The purpose of this investigational study is to determine if a study medication is safe and~     effective in reducing the symptoms associated with endometriosis; if the study medication~     reduces the need for pain medication for endometriosis symptoms; and if the study medication~     improves a participant's ability to carry out daily activities. Qualified participants will~     receive no cost treatment, which may include study-related examinations, diagnostic~     procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified~     participants will also receive study medication at no cost. As a participant, the study~     volunteer may also experience the satisfaction of knowing she is helping the advancement of~     women's health care.~   "
262715|NCT00110474|"~     The primary objective of this study is to evaluate the efficacy and safety of glucosamine~     sulfate versus placebo on the symptoms of knee osteoarthritis after 6 months of treatment,~     using acetaminophen as a reference symptomatic medication.~   "
262716|NCT00110461|"~     The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in~     child and adolescent patients with bipolar I disorder, manic or mixed episode with or without~     psychotic features.~   "
262717|NCT00110448|"~     The purpose of this study is to determine the effects of low-dose aspirin for the primary~     prevention of vascular events in patients with type 2 diabetes in Japan.~   "
262718|NCT00110435|"~     The purpose of this 10-week study is to compare the reduction in cholesterol following~     treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and~     hypercholesterolemia.~   "
262719|NCT00110422|"~     The purpose of this clinical research study is to learn if irbesartan is superior to~     hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in~     hypertensive patients with metabolic syndrome.~   "
262720|NCT00110409|"~     The objective of this randomized trial is to assess the effectiveness of an intervention~     involving education, self-efficacy, and social support in improving quality of life outcomes~     among 296 adult asthma patients treated in the emergency room. The main outcome will be a~     comparison of within-patient change in quality of life between enrollment and 8 weeks.~     Secondary objectives will be to assess the effectiveness of the intervention in decreasing~     the need for rescue inhaled beta agonists, in improving peak flow meter rates, and in~     decreasing the number of days lost from work or school due to asthma. These outcomes will be~     measured again at 16 weeks to determine if benefits are sustained. Additional outcomes at 16~     weeks and 1 year will be to assess the effectiveness of the intervention in decreasing urgent~     resource utilization for asthma and cost effectiveness.~   "
262721|NCT00110396|"~     The primary objective of the study is to compare the immunogenicity of the new fetal bovine~     serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.~   "
263694|NCT00097006|"~     To conduct epidemiological, laboratory, and survey research on volunteer blood donors within~     the United States to ensure the safety and availability of the United States' blood supply.~   "
262722|NCT00110383|"~     1. Develop a simple school-based intervention using school-based supervised asthma therapy~          to increase adherence to asthma medication.~        2. Implement a school-based internet monitoring system within both the school-based~          supervised asthma therapy and parent supervised asthma therapy groups to record asthma~          symptoms, peak flow meter readings, school absences, and usage of rescue medications at~          school.~        3. Randomly assign 250 children from inner-city school systems to either school-based~          supervised asthma therapy or parental supervised asthma therapy.~        4. Compare children assigned to school-based supervised asthma therapy with children~          assigned to parent supervised asthma therapy, in regards to time-averaged proportion~          having at least one exacerbation per month, rescue medication use, peak flow meter~          readings, asthma symptoms, school absences, and asthma self-management knowledge.~   "
262723|NCT00110370|"~     The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given~     three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with~     the addition of insulin lispro given three times daily with meals). The study is also~     comparing two different methods for adjusting the dose of insulin.~   "
262724|NCT00110357|"~     The purpose of this clinical research study is to establish the maximum tolerated dose and~     recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and~     adolescent patients with refractory solid tumors.~   "
262725|NCT00110344|"~     This study has been designed to study patients diagnosed with advanced renal cell cancer with~     the primary tumor in place.~   "
262726|NCT00110331|"~     This study will examine how HIV affects the brain and nervous system, learning, and behavior~     in children on highly active antiretroviral therapy (HAART). Although HAART has resulted in~     fewer HIV-infected children getting sick and even fewer dying from AIDS, many children on~     this treatment regimen develop significant brain or nervous system problems, such as learning~     difficulties, attention problems, hyperactivity, and depression.~      People who acquired HIV disease in the first decade of life and who have evidence of central~     nervous system (CNS) disease (e.g., encephalopathy, CNS compromise, ADHD, bipolar disease,~     major depression or psychosis) may be eligible for this study. Candidates are screened with a~     medical history, physical examination, neuropsychological testing and a CT scan of the head,~     if one has not been done within 12 months of entering the study.~      Participants undergo the following tests and procedures:~        -  MRI and MRS scan of the head: These tests use a magnetic field and radio waves to obtain~          images of the brain and detect changes in certain brain chemicals that may be affected~          by HIV infection. Both procedures are done at the same time. The patient lies on a table~          that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud~          knocking and thumping sounds that occur during the scanning process. The procedure lasts~          about 50 to 60 minutes, during which time the patient can communicate with the staff.~        -  Neuropsychological testing: Patients' thinking and behavior are evaluated with tests to~          measure their memory, attention, language, problem-solving, academic, and motor skills~          and questionnaires to assess behavioral and emotional functioning, quality of life, and~          adherence to HIV medication. Parents are also asked to complete questionnaires assessing~          their child's behavioral and emotional functioning, quality of life, important life~          events, and adherence to HIV medication.~        -  Lumbar puncture (spinal tap): Cerebrospinal fluid (CSF) is collected for analysis. For~          this procedure, a local anesthetic is given and a needle is inserted in the space~          between the bones in the lower back where the CSF circulates below the spinal cord. Some~          fluid is collected through the needle. Blood tests and a physical examination are done~          before the procedure to make sure it can be done as safely as possible. Patients may~          also be sedated to prevent any discomfort.~        -  Follow-up: The blood tests, MRI and MRS scans and spinal tap are repeated 1 and 2 years~          after the initial evaluation.~      Some blood and spinal fluid samples from participants are stored for possible future studies~     related to HIV research~   "
262727|NCT00110318|"~     This randomised controlled trial will evaluate the role of manual therapy and therapeutic~     exercise and corticosteroid injections in the treatment of lateral epicondylalgia (tennis~     elbow).~   "
262728|NCT00110305|"~     The purpose of this study is to evaluate the dose-response relationship of antiviral activity~     after 48 weeks treatment with 3 different dose regimens of TMC278.~   "
262729|NCT00110292|"~     This study will evaluate a program to prevent learning problems in children. The program is~     an inexpensive public health outreach program designed for families living in poverty and is~     administered through pediatricians' offices and clinics.~   "
262730|NCT00110279|"~     Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and~     other parts of the world. The purpose of this study is to test the safety of and immune~     response to a new AI vaccine in healthy adults.~      Study hypothesis: Influenza A viruses are widely distributed in nature and infect a wide~     variety of birds and mammals. The direct transmission of avian influenza viruses from birds~     to humans has recently become a major health concern in Asia and other parts of the world,~     raising concern of a possible influenza pandemic in humans. This vaccine will evaluate the~     safety, infectivity and immunogenicity of Live Influenza A vaccine H9N2 (6-2) AA ca~     reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a cold-adapted, live~     attenuated virus vaccine administered intranasally for the protection of humans against~     pandemic influenza viruses of the H9N2 subtype.~   "
262731|NCT00110266|"~     The purpose of this trial is to examine the safety and efficacy of deferasirox in patients~     with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.~   "
262732|NCT00110253|"~     S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a new skin numbing cream made of~     lidocaine and tetracaine. The purpose of this study is to evaluate and measure the length of~     time the S-Caine Peel numbs the skin, when applied for 30 and 60 minutes.~   "
262733|NCT00110240|"~     This study is not being conducted in the United States. The purpose of this study is to~     assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose~     in lowering overall blood glucose levels in people with type 2 diabetes who have not been~     previously treated with drug therapy to lower their blood sugar.~   "
262734|NCT00110227|"~     The purpose of this study is to determine the effects of a tai chi exercise program on~     functional capacity and health-related quality of life in patients with chronic heart failure~     (HF). This study will also examine the way tai chi influences mental, physical, and social~     functioning.~   "
262735|NCT00110214|"~     This randomized phase III trial is studying docetaxel, prednisone, and bevacizumab to see how~     well they work compared to docetaxel and prednisone in treating patients with prostate cancer~     that did not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and~     prednisone, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It~     is not yet known whether docetaxel, prednisone, and bevacizumab are more effective than~     docetaxel and prednisone in treating prostate cancer.~   "
262736|NCT00110201|"~     The purpose of this trial is to study the use of nesiritide in thoracic aneurysm repair to~     prevent acute renal failure.~      The study hypothesis: Nesiritide, given prophylactically prior to surgery may prevent acute~     renal failure requiring dialysis and/or decrease mortality.~   "
262737|NCT00110188|"~     The purpose of this study is to assess the antitumor activity of weekly ridaforolimus study~     treatment in participants with taxane-resistant AIPC.~   "
262738|NCT00110175|"~     This study will determine in stroke patients whether stimulation of the injured side of the~     brain combined with stimulation of the weak hand can temporarily improve motor function of~     the paralyzed hand. It will also examine whether stimulation of the healthy side of the brain~     combined with stimulation of the weak hand can temporarily improve motor function in the~     paralyzed hand.~      Healthy adult volunteers and adults who have had a stroke more than 3 months before entering~     the study may be eligible to participate. Candidates are screened with a physical and~     neurological examination. Stroke patients also have magnetic resonance imaging (MRI), a test~     that uses a strong magnetic field and radio waves to obtain images of the brain.~      Participants perform several tasks (described below) in a practice session and then during~     five more sessions on separate days. They perform the tasks before and after undergoing~     transcranial direct current stimulation (tDCS) plus electrical stimulation (ES), and during a~     procedure that involves sham stimulation. For tDCS, small rubber electrodes are soaked with~     water and taped to the subject's head, one above the eye and the other on the back of the~     head. The current passes between the two electrodes. For ES, two pairs of electrodes are~     attached to the subject's wrist with a paste. A very short pulse of current is passed between~     the electrodes, creating an electrical field that stimulates the brain. For the sham~     stimulation, the electrodes are similarly placed, but there is no stimulation. The tasks are:~        -  Jebsen-Taylor test: Subjects write, lift small common objects like paper clips, and~          perform activities like turning pages, stacking checkers or lifting large objects. They~          do these tasks as fast as possible.~        -  Pinch force: Subjects press a wedged instrument between their thumb and index finger as~          hard as they can. There are several trials every 10 seconds.~        -  Speed tapping: Subjects press a key on a keyboard as quickly as possible for 10 seconds.~        -  Simple reaction time task: Subjects perform a quick wrist movement as quickly as~          possible in response to a go signal presented on a computer monitor. Muscle activity~          in the forearm is recorded using electrodes.~        -  Motor sequence learning/Learning a finger movement sequence: Subjects practice a finger~          movement exercise on a keyboard by pressing keys that correspond to a number displayed~          on a video screen.~        -  Visual analog scales: Subjects complete three questionnaires about their attention,~          fatigue, and mood.~        -  Sensory monitoring: Subjects are blindfolded and asked to judge the difference in~          various sensations, such as the feel of plastic domes with gratings, vibration, or a~          plastic hair applied to their fingertip.~        -  Scoring MRC scale: The muscle strength of the subject's hands is measured.~        -  Fugl-Meyer scale: The subject's ability to move his or her limbs is measured.~        -  Mini-mental state examination: The subject's mental ability is measured briefly.~        -  Handedness questionnaire: The subject's dominant hand is determined.~      Participants also undergo transcranial magnetic stimulation (TMS) and electromyography (EMG)~     before, during and after these activities. For TMS, a wire coil is held on the scalp. A brief~     electrical current is passed through the coil, creating a magnetic pulse that stimulates the~     brain. The effect of TMS on the muscles is detected with small electrodes taped to the skin~     of the arms or legs. EMG measures the electrical activity of the muscles. For this test,~     small electrodes are taped to the skin over the muscle.~   "
262739|NCT00110162|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation~     therapy may stop the adrenal glands from making androgens.~      PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy~     works in treating patients with prostate cancer.~   "
262740|NCT00110149|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others, such as yttrium Y 90~     ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances~     to them without harming normal cells. Giving rituximab together with yttrium Y 90 ibritumomab~     tiuxetan may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with yttrium Y 90~     ibritumomab tiuxetan works in treating patients with indolent non-Hodgkin's lymphoma.~   "
262741|NCT00110136|"~     RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer.~      PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot~     flashes in women with non-metastatic breast cancer.~   "
262742|NCT00110123|"~     RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving the drugs in different ways may kill more tumor cells. It is not yet known whether~     giving fotemustine as an intravenous infusion is more effective than giving it as a hepatic~     arterial infusion in treating liver metastases.~      PURPOSE: This randomized phase III trial is studying intravenous infusion of fotemustine to~     see how well it works compared to hepatic arterial infusion of fotemustine in treating~     patients with unresectable liver metastases from eye melanoma.~   "
262743|NCT00110110|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, and vincristine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the~     growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cyclosporine~     together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed.~     Cryotherapy kills tumor cells by freezing them. Laser therapy uses light to kill tumor cells.~     Giving combination chemotherapy together with cyclosporine followed by cryotherapy and/or~     laser therapy may be an effective treatment for retinoblastoma.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with cyclosporine followed by cryotherapy and/or laser therapy works in treating patients~     with newly diagnosed retinoblastoma in both eyes.~   "
262744|NCT00110084|"~     RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin~     Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine~     works in treating women with metastatic breast cancer.~   "
262745|NCT00110071|"~     This phase I trial studies the side effects and best dose of fludarabine (fludarabine~     phosphate) when given together with iodine I 131 tositumomab in treating older patients who~     are undergoing an autologous or syngeneic stem cell transplant for relapsed or refractory~     B-cell non-Hodgkin's lymphoma (NHL). Radiolabeled monoclonal antibodies, such as iodine I 131~     tositumomab, can find cancer cells and carry cancer-killing substances to them without~     harming normal cells. Drugs used in chemotherapy, such as fludarabine, work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that~     were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 tositumomab~     together with fludarabine followed by autologous stem cell transplant may be an effective~     treatment for NHL~   "
262746|NCT00110058|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy~     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.~     It also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune system and help destroy any remaining cancer~     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor~     lymphocyte infusion) or interferon alfa after the transplant may help increase this effect.~     Sometimes the transplanted cells from a donor can also make an immune response against the~     body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may~     stop this from happening.~      PURPOSE: This phase II trial is studying how well giving fludarabine together with radiation~     therapy works in treating patients who are undergoing donor stem cell transplant for chronic~     phase or accelerated phase chronic myelogenous leukemia.~   "
262747|NCT00110045|"~     RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal~     infections caused by chemotherapy or stem cell transplant.~      PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line~     treatment for aspergillosis in patients with hematologic cancer or in patients who have~     undergone a stem cell transplant.~   "
262748|NCT00110032|"~     This phase I trial is studying the side effects of fluorine F18 EF5 when given during~     positron emission tomography to find oxygen in tumor cells of patients who are undergoing~     surgery or biopsy for newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18~     EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer~     treatment~   "
262762|NCT00109824|"~     Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Valproic acid~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving decitabine together with valproic acid may be an effective treatment for non-Hodgkin's~     lymphoma. This phase I trial is studying the side effects and best dose of decitabine and~     valproic acid in treating patients with relapsed or refractory aggressive B-cell~     non-Hodgkin's lymphoma.~   "
262749|NCT00110019|"~     This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to~     see how well they work compared to carboplatin and paclitaxel in treating patients with stage~     III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such~     as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by~     blocking blood flow to the tumor. It is not yet known whether giving carboplatin and~     paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel~     in treating melanoma.~   "
262750|NCT00110006|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using~     fludeoxyglucose F 18, may help in learning how well chemotherapy works to kill cancer cells~     and allow doctors to plan better treatment. Comparing results of diagnostic procedures done~     before, during, and after chemotherapy may help doctors predict a patient's response to~     treatment and help plan the best treatment.~      PURPOSE: This clinical trial is studying positron emission tomography using fludeoxyglucose F~     18 to see how well it works in predicting response to treatment in patients who are receiving~     rituximab and combination chemotherapy for newly diagnosed non-Hodgkin's lymphoma.~   "
262751|NCT00109993|"~     RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for~     graft-versus-host disease caused by a donor stem cell transplant.~      PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus~     and methylprednisolone works in treating acute graft-versus-host disease in patients who have~     undergone donor stem cell transplant.~   "
262752|NCT00109980|"~     The purpose of this study is to investigate and compare the use of herbal medicine among~     Dominicans in New York City and the Dominican Republic.~   "
262753|NCT00109967|"~     This phase II trial is studying how well giving CCI-779 together with rituximab works in~     treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in~     chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells~     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Giving CCI-779 together with rituximab may kill more cancer cells~   "
262754|NCT00109954|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. In this~     case, chemotherapy is given through the artery (hepatic artery) that brings blood to the~     tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and~     keeping chemotherapy drugs near the tumor. Internal radiation uses radioactive material~     placed directly into or near a tumor to kill tumor cells. It is not yet known whether hepatic~     arterial chemoembolization with cisplatin is more effective than internal radiation therapy~     in treating liver cancer.~      PURPOSE: This randomized phase III trial is studying hepatic arterial chemoembolization with~     cisplatin to see how well it works compared to internal radiation therapy in treating~     patients with advanced liver cancer that cannot be removed by surgery.~   "
262755|NCT00109941|"~     RATIONALE: Opioid growth factor may stop the growth of pancreatic cancer by blocking blood~     flow to the tumor.~      PURPOSE: This phase II trial is studying how well opioid growth factor works in treating~     patients with advanced pancreatic cancer that cannot be removed by surgery.~   "
262756|NCT00109928|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, gemcitabine, and~     methylprednisolone, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     patients with newly diagnosed stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.~   "
262757|NCT00109889|"~     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and~     fludeoxyglucose F 18 positron emission tomography (^18FDG-PET) may help diagnose solitary~     plasmacytoma.~      PURPOSE: This clinical trial is studying MRI and ^18FDG-PET to see how well they work in~     diagnosing patients with solitary plasmacytoma.~   "
262758|NCT00109876|"~     This pilot clinical trial studies how well radiofrequency ablation works in treating patients~     with stage IA non-small cell lung cancer. Radiofrequency ablation uses high-frequency~     electric current to kill tumor cells. Computed tomography (CT)-guided radiofrequency ablation~     may be a better treatment for non-small cell lung cancer.~   "
262759|NCT00109863|"~     RATIONALE: Biological therapies, such as hu14.18-interleukin-2 fusion protein, may stimulate~     the immune system in different ways and stop tumor cells from growing.~      PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works~     in treating patients with advanced melanoma.~   "
262760|NCT00109850|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth~     of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     cetuximab together with combination chemotherapy and radiation therapy may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination~     chemotherapy and radiation therapy works in treating patients with locally advanced~     esophageal cancer that cannot be removed by surgery.~   "
262761|NCT00109837|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy), and giving the drugs in different combinations may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     patients with newly diagnosed acute lymphoblastic leukemia.~   "
262763|NCT00109811|"~     This phase II trial is studying how well vaccine therapy works in treating patients with~     recurrent prostate cancer. Vaccines made from peptides may help the body build an effective~     immune response to kill tumor cells~   "
262764|NCT00109798|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving temozolomide together with topotecan~     works in treating patients with primary CNS lymphoma.~   "
262765|NCT00109785|"~     RATIONALE: Imaging procedures such as PET scans may improve the ability to monitor the~     effectiveness of chemotherapy for locally advanced breast cancer.~      PURPOSE: This clinical trial is studying how well PET scans work in patients with locally~     advanced breast cancer who will undergo chemotherapy.~   "
262766|NCT00109772|"~     The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the~     efficacy and safety of Lenalidomide in adult subjects with Complex Regional Pain Syndrome~     (CRPS) Type 1.~   "
262767|NCT00109759|"~     The safety and tolerability of tyrosine adsorbed ragweed pollen allergoid with monophosphoryl~     lipid A (MPL) will be evaluated. For this purpose, a total of 4 injections of either~     increasing doses of the study drug or placebo (tyrosine) will be administered in 7-day~     intervals to healthy volunteers.~   "
262768|NCT00109746|"~     The purpose of this study is to determine the effectiveness of the nutritional supplement~     chromium picolinate in improving insulin resistance, a symptom of diabetes, in HIV-infected~     patients. The ultimate goal is to find a simple therapy that can prevent the development of~     diabetes in individuals with HIV.~   "
262769|NCT00109733|"~     The primary objective is to evaluate the efficacy and safety of two different dose regimens~     of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during~     the transition phase from childhood to adulthood.~   "
262770|NCT00109720|"~     The purpose of this study is to find out if Self-Management Consultant (SMC) intervention~     will be more effective than usual care in improving blood glucose control and~     diabetes-related quality of life for adults with type 2 diabetes.~   "
262771|NCT00109707|"~     The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity,~     and pharmacokinetics of AMN107 in six groups of patients with one of the following~     conditions:~      Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1)~      Group A - Imatinib failure only (arms 2, 3 and 4)~        -  imatinib-resistant or intolerant CML - Chronic Phase (CP)~        -  imatinib-resistant or intolerant CML - Accelerated Phase (AP)~        -  imatinib-resistant or intolerant CML - Blast Crisis (BC)~      Group B - Imatinib and other TKI failure (arms 2, 3 and 4)~        -  imatinib-resistant or intolerant CML - Chronic Phase (CP)~        -  imatinib-resistant or intolerant CML - Accelerated Phase (AP)~        -  imatinib-resistant or intolerant CML - Blast Crisis (BC)~      Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5)~      Systemic mastocytosis (Sm) (arm 6)~   "
262772|NCT00109681|"~     The primary purpose of this study is to determine whether iloprost inhalation solution is~     safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial~     pressure. The secondary purpose is to evaluate the effectiveness of this treatment in~     subjects with this disease.~   "
262773|NCT00109668|"~     QVAR in a standard press and breath inhaler (QVAR-MDI) has been approved by the Food and Drug~     Administration (FDA) for use in the United States. The purpose of this study is to determine~     the level of asthma control when comparing the safety and effectiveness of QVAR in two~     different devices, a metered dose inhaler (MDI) and a breath operated inhaler (BOI).~   "
262774|NCT00109655|"~     The main purpose of this research study is to evaluate the safety and dosing of CG0070.~   "
262775|NCT00109642|"~     This study will examine the role of a brain chemical called norepinephrine in thinking,~     decision-making, and emotional processing. After norepinephrine is released from a brain~     cell, it binds to another brain cell's receptor. Some of the receptors it binds to are called~     alpha-2 adrenergic receptors. This study will use medicines called yohimbine and guanfacine~     to look at the function of norepinephrine in the brain when it binds to the alpha-2~     adrenergic receptors. Yohimbine increases norepinephrine's function and guanfacine decreases~     its function.~      Healthy volunteers between 20 and 50 years of age who do not have heart disease, high blood~     pressure, psychiatric illness, or other serious medical conditions and who are not allergic~     to lactose may be eligible for this study. Candidates are screened with a medical and~     psychiatric history, physical examination, neuropsychological testing, blood and urine tests~     and electrocardiogram. Women are screened with a urine pregnancy test.~      Participants are given a pill of yohimbine, guanfacine, or placebo and undergo the following~     tests and procedures:~        -  Blood pressure and heart rate measurements: Blood pressure and heart rate are measured~          before the medication is taken and several times after.~        -  Blood draws: Blood is drawn before the medicine is taken and 90 minutes after to measure~          levels of norepinephrine and the hormone cortisol.~        -  Neurocognitive testing: Participants do neurocognitive tasks on the computer for up to~          90 minutes. The tasks involve looking at pictures or words on a screen and responding~          according to instructions given.~        -  Magnetic resonance imaging (MRI): Patients may undergo neurocognitive testing MRIs. This~          test uses a strong magnetic field and radio waves to show changes in brain activity. The~          subject lies on a table that slides into a narrow cylinder (the MRI scanner). Images of~          the brain are obtained while the subject performs the computer tasks.~   "
262776|NCT00109629|"~     This study will determine the safety and side effects of two experimental HIV vaccines given~     in a prime-boost schedule. It will also monitor participants for the social impact of being~     in an HIV vaccine study (e.g., problems with insurance, health care, friends, family,~     employment, housing, and so forth). The vaccines are VRC-HIVDNA016-00-VP (called the DNA~     vaccine) and VRC-HIVADV014-00-VP (called the rAd vaccine). The DNA vaccine codes for four HIV~     proteins. The rAd vaccine is made using an adenovirus (a common virus that causes upper~     respiratory infections, such as the common cold) that has been modified to contain DNA that~     codes for three HIV proteins. These vaccines cannot cause HIV or adenoviral infections.~      The study will also see if the vaccines cause an immune response; if the injection of the DNA~     vaccine given using a needle and syringe is similar in safety and immune response to giving~     them with a needleless injection device called a Biojector 2000; if people who already have~     antibodies to adenovirus still have an immune response to rAd vaccine; and if there are~     social harms that result from participating in an HIV vaccine study.~      Healthy volunteers between 18 and 50 years of age may be eligible for this 42-week study.~     Candidates are screened with a medical history, physical examination, blood and urine tests~     (including pregnancy test for women), and questions regarding sexual behavior and other~     practices.~      Participants receive three injections (shots) of the DNA vaccine and one injection of the rAd~     vaccine. All injections are given into a muscle in the upper arm (alternating right and left~     arms with each injection), using a needle and syringe or the needleless Biojector 2000. The~     first vaccination is given the day of enrollment into the study, and the DNA vaccinations are~     given about 4 weeks apart from each other, with a minimum of 21 days between injections. The~     rAd boostervaccination is given at Week 24. Participants fill out a diary card at home for~     5 days after each vaccination, recording their temperature and any symptoms. They come to the~     clinic for follow-up 3 days each DNA vaccine injection, and call or return again 7 days after~     each injection. They call a study nurse 1 or 2 days after the rAd injection.~      There are 15 to 18 clinic visits during the course of the study. At each visit, participants~     are checked for health changes or problems. Blood and urine samples are collected at some~     visits. Participants are periodically tested for HIV and asked questions about their sexual~     behavior and drug use and are counseled throughout the study on HIV risk reduction. They are~     also asked about any social effects they may have experienced as a result of their~     participation in this study.~   "
262796|NCT00109369|"~     The Vermont Diabetes Information System (VDIS) is a registry-based decision support and~     reminder system based on the Chronic Care Model and targeted to primary care physicians and~     their patients with diabetes. It will be evaluated by a randomized, controlled study in 60~     Primary Care practices in Vermont and nearby New York.~   "
262777|NCT00109616|"~     Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver~     babies at home without a skilled birth attendant.~      The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with~     a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of~     life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and~     water or an antiseptic solution for the first few days of life can reduce umbilical cord~     infections.~   "
262778|NCT00109603|"~     The purpose of this study is to determine the effect of the anti-HIV drug tenofovir~     disoproxil fumarate (TDF) on lipid levels in HIV infected adults on stable anti-HIV drug~     therapy.~      Study hypothesis: The addition of TDF to stable background antiretroviral therapy in HIV~     infected individuals with dyslipidemia will result in a reduction of non-HDL after 12 weeks~     of treatment.~   "
262779|NCT00109590|"~     The purpose of this study is to determine which of 3 different anti-HIV drug regimens given~     to HIV infected pregnant women during and after their pregnancies is most effective in~     reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and~     lopinavir/ritonavir (LPV/r) will also be studied.~      Study hypothesis: NVP resistance following single-dose NVP can be prevented with the~     concomitant administration of additional antiretroviral therapy (ART).~   "
262780|NCT00109577|"~     The purpose of the trial was to determine whether a 36-ingredient micronutrient supplement~     (primarily vitamins and minerals) is beneficial for the treatment of bipolar disorder, when~     studied under randomized and fully blinded conditions and compared to a placebo. The~     supplement is referred to as MCN36, because it contains 36 nutrients. Based on the~     preliminary research on this supplement, it is hypothesized that patients who take MCN36 for~     8 weeks will experience improved mood stability relative to those who take the placebo. All~     participants must live EITHER in the vicinity of Calgary, Alberta, Canada, OR in the area of~     San Diego, California.~   "
262781|NCT00109564|"~     The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline~     (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated~     memory impairment (AAMI). AAMI is characterized as cognitive impairment including memory loss~     and poor concentration associated with aging.~   "
262782|NCT00109551|"~     The purpose of this study is to determine whether daily supplementation of young children in~     Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young~     children in Nepal have numerous nutritional deficiencies and high rates of morbidity and~     mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these~     risks.~   "
262783|NCT00109538|"~     The purpose of this study is to assess the benefit of lonafarnib (versus placebo) in patients~     with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). Benefit will~     be measured by achievement of platelet transfusion independence for at least 8-consecutive~     weeks, and without simultaneous worsening of hemoglobin and/or need for red blood cell (RBC)~     transfusion. Additional endpoints will be hematologic response (which includes complete~     remission, partial remission, hematologic improvement), number of RBC transfusions, bleeding~     events, infections and safety.~   "
262784|NCT00109525|"~     This observational study evaluated the performance of new lab tests in detecting candida~     species fungal infections in extremely low birth weight (ELBW) infants quickly and~     accurately. 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth~     weights ≤1,000g; 100 of these infants later tested positive for candidiasis. Blood, urine,~     and lumbar puncture samples were collected whenever other specimens were obtained from~     participants for cultures. These samples are being tested using the new methods and compared~     with standard culture results. Surviving study subjects completed a neurodevelopmental~     evaluation at 18-22 months corrected age.~   "
262785|NCT00109512|"~     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in~     a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at~     the end of Week 12, follow-up continued every 4 weeks for 12 weeks.~   "
262786|NCT00109499|"~     The primary purpose of this study is to assess the safety of AdGVPEDF.11D when given to~     patients with wet age-related macular degeneration (AMD). AdGVPEDF.11D is a replication~     deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for the PEDF (pigment~     epithelium-derived factor) protein. PEDF is a protein that naturally exists in the human eye,~     but whose levels are altered in diseases characterized by ocular neovascularization like AMD.~     The PEDF protein is known to have anti-angiogenic effects or, in other words, it has the~     ability to inhibit growth of new blood vessels.~      AdGVPEDF.11D will be delivered once via intravitreal injection into one eye. The injected eye~     will be the eye with the worst visual acuity.~   "
262787|NCT00109486|"~     The purpose of this study is to assess any effect in children with seasonal and/or perennial~     allergic rhinitis by GW685698X aqueous nasal spray (versus vehicle placebo nasal spray) on~     growth using knemometry.~   "
262788|NCT00109473|"~     The purpose of this study is to determine whether taking a growth hormone (GH) drug called~     somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when~     compared to a person with Crohn's Disease that does not receive growth hormone drug.~   "
262797|NCT00109356|"~     The purpose of this study is to find answers to the following questions:~        -  What is the largest dose of AQ4N that can be given safely one time every three weeks for~          24 weeks?~        -  What are the side effects of AQ4N when given according to this schedule?~        -  How much AQ4N is in the blood at certain times after administration and how does the~          body get rid of the drug?~        -  Will AQ4N help treat lymphoid cancer?~   "
262798|NCT00109343|"~     The study is being conducted to demonstrate that V221 may be administered concomitantly with~     pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles,~     mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.~   "
262799|NCT00109330|"~     This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine~     compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of~     age).~   "
262800|NCT00109317|"~     This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled,~     multicenter study designed to evaluate the safety and tolerability of efalizumab administered~     subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque~     psoriasis who are candidates for systemic therapy.~   "
262789|NCT00024635|"~     The purpose of this protocol is to allow for the careful screening of patients and healthy~     volunteers for participation in research protocols in the Experimental Therapeutics and~     Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the~     collection of natural history data. In addition the protocol will allow clinicians to gain~     more experience in the use of a variety of polysomnographic and high-density EEG recordings.~     Subjects in this protocol will undergo an evaluation which may include: a psychiatric~     interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain~     magnetic resonance imaging (MRI); electroencephalography (EEG); electrocardiography (EKG),~     magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request~     for medical records. Subjects may also be asked to complete questionnaires about attitudes~     towards research and motivation for research participation. The data collected may also be~     linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA,~     psychophysiology tests, treatment studies, etc) for the purposes of better understanding the~     diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents~     of minors will be interviewed. Upon conclusion of the screening process, subjects will either~     be offered participation in a research protocol and will sign the appropriate informed~     consent, or will be considered not appropriate for participation in research and will be~     referred back into the community. The current protocol thus serves as an entry point for~     individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved~     ETPB protocols.~   "
262790|NCT00109460|"~     The project's aim is to provide a targeted, computer-administered intervention to facilitate~     tobacco cessation for clients in alcohol treatment. The main focus of On the Air: A tobacco~     cessation program for adults in alcohol recovery is to reduce tobacco use of clients in~     alcohol treatment. The program will be offered through inpatient, residential, and outpatient~     treatment programs to help those struggling with alcohol addiction to understand, reduce, and~     stop tobacco use. Clients will develop a personalized tobacco cessation plan relevant to~     their readiness to quit tobacco use. Based on the metaphor of a television network, this~     tobacco cessation program contains information on personal risks, peer stories, cravings and~     withdrawal, a variety of interactive activities and tools, and also motivational feedback and~     tips to assist in the quitting process. Phase I was a proof of concept phase, in which we~     delivered a prototype CD-ROM on tobacco cessation. Phase II will involve completing the~     development of a functional CD-ROM tool which will be subjected to a clinical field trial~     with a group of adults (n=196) in treatment facilities for alcohol recovery. The clinical~     field study will involve finalizing the content, interface, and interactive features of the~     CD-ROM. We will also gather satisfaction data from both clients and counselors in the various~     treatment facilities.~   "
262791|NCT00109434|"~     The main purpose of this study is to find out how often low blood sugar (hypoglycemia)~     happens during the night after exercise in the late afternoon. The study also will see if~     there are any factors that can predict if low blood sugar is going to develop. Blood samples~     will also be drawn to measure two hormones—glucagon and epinephrine (adrenaline)—to see how~     they are affected by exercise. Glucagon helps to raise the blood sugar when it is low.~     Epinephrine causes symptoms that make the person aware that the blood sugar is low. From the~     blood sample, other substances in the blood may also be measured to see how they are affected~     by exercise.~      A second purpose of the study is to find out whether exercise affects the accuracy of a~     continuous glucose sensor (CGMS made by Medtronic Minimed).~      The study will also look at the accuracy of different home glucose meters.~   "
262792|NCT00109421|"~     The Project ÒRÉ intervention is a half-day community-based HIV/STI intervention program for~     friendship groups of adolescents that is tailored to African American culture. The four~     participating community sites will be assigned to either the Project ÒRÉ intervention or a~     standard health promotion program. Sexually experienced African American adolescent females~     will recruit members of their friendship group for the five-hour program. All participants~     will complete questionnaires before and immediately following the programs and another one 3~     months later. Immediately following the program some of the Project ÒRÉ groups will also~     participate in a focus group to provide feedback about the program.~   "
262793|NCT00109408|"~     This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus~     methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized~     to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate~     7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is~     3-12 months and the target sample size is 500+ individuals.~   "
262794|NCT00109395|"~     This clinical trial is being performed under the Best Pharmaceuticals for Children Act,~     signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The~     purpose of this study is to make sure that lorazepam, when given to children who are very~     sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well~     as a drug called midazolam. Midazolam is already approved by the FDA for this use, but~     lorazepam is not, even though both drugs are commonly used for sedation.~   "
262795|NCT00109382|"~     Current management of patients with TIA (transient ischemic attack) or minor stroke includes~     the prompt investigation and treatment in the days and weeks after the event. However, new~     evidence shows patients are at the highest risk of stroke in the first few days after the~     TIA, with 50% of strokes which happen in the three months following TIA occurring within~     48-72 hours. To date, there is no evidence to guide physicians on how to safely reduce this~     risk.~      The FASTER trial is focusing on the initial period of high risk, starting patients on stroke~     prevention treatments in the hours following a TIA or minor stroke. The drugs to be tested~     have been shown to be effective in the similar setting of cardiology, reducing recurrent~     cardiac events in patients with unstable angina when commenced with the same speed after an~     event.~      All patients will be on aspirin. The trial will see if adding another drug, clopidogrel, has~     an additional benefit in reducing the number of strokes after TIA or minor stroke within~     three months of TIA or minor stroke. It will also look if the very early introduction of~     simvastatin, a cholesterol lowering therapy, reduces stroke after TIA or minor stroke, both~     by itself and in addition to clopidogrel. The final aim of the trial is to ensure that these~     treatments are safe to be used in this population of patients.~   "
272904|NCT00021892|"~     To assess the diagnostic and prognostic usefulness of serum markers of left ventricular~     remodeling for predicting congestive heart failure.~   "
262801|NCT00109304|"~     This study is being done to determine the safety and tolerability of a new investigational~     vaccine referred to as VEE IA/B V3526, which may induce production of specific antibodies in~     vaccinated humans, and may protect them against infection with the Venezuelan Equine~     Encephalitis (VEE) Virus.~   "
262802|NCT00109291|"~     To evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in~     participants with chronic kidney disease(CKD) not on dialysis.~   "
262803|NCT00109278|"~     The purpose of this study is to test the safety of a measles, mumps, and rubella study~     vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA~     (recombinant human albumin).~   "
262804|NCT00109265|"~     This is a Phase II, multicenter trial of single-agent treatment with OSI 774 in patients with~     histologically confirmed, incurable, locally advanced or metastatic breast cancer. Patients~     must have measurable disease.~   "
262805|NCT00109252|"~     This is an open-label, multicenter study designed to evaluate the efficacy and safety of~     efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab~     taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.~   "
262806|NCT00109239|"~     This Phase III, multicenter, randomized, active-controlled, open-label trial is designed to~     evaluate the efficacy, safety, and pharmacokinetics of rhuMAb VEGF when combined with~     capecitabine compared with capecitabine alone in subjects with previously treated metastatic~     breast cancer.~   "
262807|NCT00109226|"~     This Phase II, multicenter, double-blind, randomized, active-controlled trial is designed to~     evaluate the efficacy and safety of rhuMAb VEGF (Avastin) when administered at a dose of 5~     mg/kg every 2 weeks in combination with 5 FU (fluorouracil)/leucovorin versus 5 FU/leucovorin~     alone in subjects with previously untreated metastatic colorectal cancer who are not optimal~     candidates to receive first-line CPT-11 (irinotecan). A total of 48 doses of rhuMAb VEGF may~     be administered during this study (maximum of 96 weeks of therapy).~   "
262808|NCT00109213|"~     The purpose of the study is to determine the proper use of lower back screws and rods~     (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing~     (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another~     (spondylolisthesis). There are two types of operations that surgeons perform for this~     problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the~     nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is~     also important to strengthen the back by placing screws and rods into the spine and adding~     more bone to obtain a new bridge of bone away from the nerves (decompression with~     instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion~     to a decompression for this spinal problem will improve long term patient outcomes.~   "
262809|NCT00109200|"~     This is a continued access protocol to provide subjects who have completed Genentech, Inc.~     Study Q2143g, Q2195g, or Q2461g or Novartis Pharmaceuticals Corporation Study CIGE025 0010E1~     with continued Xolair treatment. Subject eligibility will be based on disease severity and~     asthma deterioration upon withdrawal of Xolair treatment. Subjects whose last Xolair dose was~     <9 months prior to screening visit will continue with the same Xolair dosing regimen that~     they received in the previous Genentech or Novartis clinical study.~   "
262810|NCT00109187|"~     This is a Phase IIIb, multicenter, open-label, extension study available to subjects who~     successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should~     be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their~     baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects~     in the New Treatment Group may require additional visits for study drug injections (as~     frequently as every 2 weeks). Data collection during these additional visits will be limited~     to the assessment of adverse events. The study will evaluate all serious and nonserious~     adverse events, laboratory assessments, data on asthma exacerbations, and concomitant~     medication usage.~   "
262811|NCT00109174|"~     This study will use magnetic resonance spectroscopy (MRS) to measure in the brain the~     transfer of [13]C as it is naturally metabolized from glucose to specific chemical~     transmitters. From this method, we can measure the rate of production of an important~     excitatory neurotransmitter (glutamate) as well as an inhibitory neurotransmitter (GABA).~   "
262812|NCT00109161|"~     This research study is being conducted in the U.S. and Europe to evaluate the safety and~     efficacy of daclizumab for the treatment of multiple sclerosis (MS).~   "
262813|NCT00109148|"~     The purpose of this study is to determine the safety and effectiveness of an investigational~     drug in patients with obesity (considerably overweight).~   "
262814|NCT00109135|"~     The purpose of this study is to evaluate the safety and tolerability of an investigational~     drug that may help individuals to stop smoking.~   "
262815|NCT00109122|"~     The purpose of this study is to determine the immunity (the body's protection) against~     shingles after receiving two doses of an investigational vaccine or placebo (a look alike~     vaccine with no active ingredients).~   "
262816|NCT00109109|"~     The purposes of this study are:~        -  To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14~          consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6~          weeks) in patients with advanced multiple myeloma;~        -  To assess the safety and overall response rate to SAHA in patients with advanced~          multiple myeloma.~   "
262817|NCT00109096|"~     The purposes of this study are to determine: - whether standard or higher doses of pemetrexed~     should be given to patients with ovarian or primary peritoneal cancer that has recurred; -~     the safety and side effects of standard and higher doses of pemetrexed given to patients with~     ovarian or primary peritoneal cancer that has recurred; - whether standard or higher doses of~     pemetrexed can help patients with ovarian or primary peritoneal cancer that has recurred.~   "
262818|NCT00109083|"~     The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment~     in reducing the number of migraine headaches when added to a person's usual medications for~     acute migraine headache relief.~   "
262819|NCT00109070|"~     This is a multicenter, Phase III, randomized, active-controlled trial to evaluate the~     efficacy and safety of rhuMAb VEGF (Avastin) added to the standard first-line chemotherapy~     used to treat metastatic colorectal cancer. This trial will enroll approximately 900 subjects~     with histologically confirmed, previously untreated, bi-dimensionally measurable metastatic~     colorectal cancer.~   "
262820|NCT00109057|"~     This is a multicenter, open-label extension study. Subjects who have received rhuMAb VEGF~     (Avastin) therapy in any Genentech-sponsored Phase I or Phase II cancer study and who did not~     show evidence of disease progression at completion of the parent study will be eligible for~     inclusion in this trial.~   "
262821|NCT00109044|"~     Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are~     selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults.~     This study is designed to evaluate the efficacy and safety of a fixed-dose escitalopram~     combination relative to its component monotherapies and to placebo in patients with major~     depressive disorder.~   "
262822|NCT00109031|"~     To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3~     consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World~     Health Organization [WHO] grade 3 and 4).~   "
262823|NCT00109018|"~     Biomarkers for Cardiovascular Disease~      Summary: This study will examine the function of the lining cells of blood vessels and~     measure substances in the blood to see how they relate to various blood tests, including new~     tests under development to determine cardiovascular disease risk. Nitric oxide is a molecule~     produced by healthy blood vessels that helps keep them relaxed. Nitrate is a substance formed~     from nitric oxide in the blood. The release of nitric oxide by blood vessels is reduced in~     patients with coronary artery disease, compared with healthy people. Also, blood nitrite~     levels rise in some of these patients. Other substances in the blood and urine also change~     with risk for heart disease. This study will measure nitrite levels and other inflammatory~     substances in the blood and urine.~      Healthy volunteers, people with various risk factors for heart disease, and people with~     blockage of one or more major heart arteries or a history of heart attack may be eligible for~     this study. Candidates must be 21 years of age or older. People who have an irregular heart~     rhythm or who cannot take oral nitrates are excluded.~      Participants undergo the following tests and procedures:~        -  Blood tests: Samples are drawn three times for routine tests and to look for certain~          proteins that may affect the heart. Samples are collected once before any other tests,~          once before starting the exercise stress test (see below) and again after the stress~          test.~        -  Urine test: A sample may be tested for proteins in the urine and for other research~          studies.~        -  Brachial artery reactivity study: This ultrasound study tests how well a person's~          arteries widen. The subject rests on a bed. An ultrasound measuring device is placed~          over the artery just above the elbow. The size of the artery and blood flow through it~          are measured before and after inflating a pressure cuff around the forearm. The pressure~          cuff stops the flow of blood to the arm for 5 minutes and then is released while more~          ultrasound pictures are taken. After the subject rests, a nitroglycerin tablet (medicine~          that causes blood vessels to relax) is placed under the tongue. After the nitroglycerin~          is given, the size of the artery and blood flow through it are measured again. After a~          rest period, the study will be repeated in the healthy volunteers and first 20 patients~          with heart disease.~        -  Echocardiography (heart ultrasound): This test involves holding a small probe against~          the chest to use sound waves for obtaining pictures of the heart. A small catheter~          (plastic tube) may be placed in a vein to inject a contrast agent that enhances the~          pictures.~        -  Metabolic stress testing: Subjects will be asked to breathe in and out of a mask while~          baseline measurements are taken. Then they exercise on a treadmill while wearing a~          breathing mask. This test shows how much oxygen the body uses at rest and with exercise.~        -  Genetic testing (optional): A blood sample is collected to examine DNA - genetic~          material that determines inherited traits and contains information about body proteins.~          Some parts of DNA may be used as markers of the level of damage produced by oxygen~          by-products that may reflect the extent of heart disease in patients. Also, gene~          variations may make an individual more likely to develop a heart problem. Such markers~          may guide doctors in predicting how fast the disease will progress or may help find a~          new type of drug to prevent disease.~        -  Time requirements: This study is expected to take approximately 5-6 hours for completion~          within one or two days.~        -  Follow-up: Patients are contacted by phone every 6 months for information on chest pain,~          surgical procedures related to the heart, and hospitalizations.~   "
262824|NCT00109005|"~     This study will test whether an experimental drug called Revlimid (lenalidomide) can reduce~     tumor size and prolong survival in patients with metastatic melanoma (melanoma that has~     spread beyond the original tumor site). It will also examine the toxicity and blood effects~     of Revlimid.~      Patients 18 years of age and older with stage IV ocular melanoma may be eligible for this~     study. Candidates are screened with a medical history and physical and examination, blood and~     urine tests, electrocardiogram, chest x-ray, computed tomography (CT) scan and other imaging~     scans if needed, such as a bone scan, magnetic resonance imaging (MRI), ultrasound, or~     positron emission tomography (PET).~      Participants are admitted to the National Institutes of Health (NIH) Clinical Center for 24~     hours for their first oral dose of Revlimid. During the hospital stay, blood is drawn before~     the dose is given and again at 0.25, 0.5, 1, 2, 4, 6, 9, 12 and 24 hours after dosing to see~     how the body handles the drug. If the drug is well tolerated, patients are sent home with a~     21-day supply of drug to take once a day for 21 days, then go off drug 7 days. This regimen~     constitutes one 28-day treatment cycle. Treatment cycles may continue for up to 2 years.~      Patients keep a daily diary of side effects and have blood drawn once a week. The drug dose~     may be adjusted according to the laboratory test results. If unacceptable toxicity occurs,~     treatment may be stopped.~      Patients who agree to be biopsied undergo this procedure before treatment begins and at the~     end of treatment cycles 3 and 6. A small area of skin is numbed with medicine and a small~     piece of tumor is removed with a needle or by a small cut in the tumor. The tissue is~     examined under a microscope.~      Patients return to NIH after the first month of treatment and then every 3 months to evaluate~     their tumors and treatment of side effects. The visits include a physical examination, x-rays~     and scans to evaluate tumors. Visits are scheduled every 3 months while on treatment; then~     every 3 months for 2 years afterwards; then every 4 months for 1 year; and as needed after~     that. Patients will have a brain magnetic resonance imaging scan once a year to watch for new~     tumor areas.~   "
262825|NCT00108992|"~     Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the~     symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side~     effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney~     abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the~     knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is~     to determine the safety and effectiveness of a topical NSAID when used alone or when combined~     with an oral NSAID in the treatment of osteoarthritis of the knee.~   "
262826|NCT00108979|"~     Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are~     selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults.~     This study is designed to evaluate the efficacy, safety, and pharmacoeconomics of~     escitalopram and an active comparator in patients with major depressive disorder.~   "
262827|NCT00108953|"~     The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus~     sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma~     (HCC).~   "
262828|NCT00108940|"~     The purpose of this study is to find the genes that increase the risk of developing an~     ischemic stroke using DNA samples collected from concordant (stroke-affected) sibling pairs.~   "
262829|NCT00108927|"~     The goal of our research program is to successfully translate empirical knowledge regarding~     diabetes treatment and management into sustainable clinical practice. The study hypothesis is~     that implementation of a multicomponent intervention will result in meaningful improvement in~     clinical performance measures at the clinic that include average A1c (Hemoglobin A1c),~     average systolic blood pressure, and national clinical performance measures at a reasonable~     cost to the health system.~   "
262830|NCT00108914|"~     The purpose of this study is to determine if the investigational drug is effective and safe~     in children with perennial allergic rhinitis.~   "
262831|NCT00108901|"~     The study is a behavioral clinical trial of aerobic exercise to determine dose-response~     effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other~     cardiovascular risk factors in overweight elementary schoolchildren.~      The hypothesis is that the more exercise a child does, the more benefit he or she will gain~     in reducing the risk of diabetes and other cardiovascular diseases.~      An ancillary study examined effects on cognition and achievement.~   "
262832|NCT00108875|"~     This study evaluates the safety, the immunological response and the clinical outcome of a~     vaccination with survivin peptides for patients with advanced melanoma, pancreatic, colon and~     cervical carcinoma.~   "
262833|NCT00108862|"~     The purpose of this study is to determine the best time to begin anti-HIV treatment in~     individuals who have HIV and tuberculosis (TB).~      Study hypothesis: Immediate antiretroviral therapy (ART), initiated after approximately 2~     weeks of TB treatment, will reduce the frequency of other AIDS-defining illnesses and death~     in HIV-infected participants being treated for TB by at least 40% at week 48 when compared to~     deferred ART, initiated at after 8-12 weeks of TB treatment.~   "
262834|NCT00108849|"~     This trial is conducted in North America. The purpose of this study is to determine if~     Vagifem Low Dose is an effective and safe treatment for patients suffering from~     postmenopausal atrophic vaginitis.~   "
262835|NCT00108836|"~     This study will test the efficacy, safety and tolerability of XBD173 in the treatment of~     generalized anxiety disorder in patients.~   "
262836|NCT00108823|"~     The purpose of this trial is to study the effects of roflumilast on lung function parameters~     indicative of hyperinflation in patients with COPD.~   "
262837|NCT00108810|"~     The purpose of the study is to evaluate the safety and effectiveness of the investigational~     ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance)~     for the treatment of pain caused by osteoarthritis.~   "
262838|NCT00108797|"~     This trial is conducted in the United States of America (USA). This study compares the~     effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with~     inhibitors being treated for joint bleeds.~   "
262839|NCT00108784|"~     This study will test the hypothesis that reducing the energy density of the diet by~     incorporating more water-rich foods will result in: 1) greater weight loss and weight~     maintenance; 2) greater diet satisfaction and satiety; and 3) more healthful dietary patterns~     than reducing dietary fat alone.~   "
262840|NCT00108771|"~     The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch~     ZR-02-01 in providing pain relief.~   "
262841|NCT00108758|"~     This trial is conducted in Africa, Asia, Europe, South America, and the United States of~     America (USA).~      The purpose of this study is to evaluate the effectiveness of secondary prophylactic~     treatment with NovoSeven® in haemophilia A and B patients with inhibitors.~   "
262842|NCT00108745|"~     This randomized phase III trial studies paclitaxel to see how well it works compared to~     polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV~     ovarian epithelial, peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy,~     such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and~     polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer~     by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need~     additional treatment until it progresses. In this case, observation may be sufficient. It is~     not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or~     observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.~   "
262843|NCT00108732|"~     Vaccines made from a gene-modified virus may help the body build an effective immune response~     to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in~     different ways and stop tumor cells from growing. Androgens can cause the growth of prostate~     cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from~     making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy~     together with GM-CSF and, when needed, androgen ablation may be a more effective treatment~     for prostate cancer. This phase II trial is studying how well giving vaccine therapy together~     with GM-CSF works in treating patients with prostate cancer that progressed after surgery~     and/or radiation therapy.~   "
262844|NCT00108706|"~     The aim of this study is to determine whether it is safe and effective to give the~     Angiotensin Receptor Blocker (ARB) Candesartan within the first 72 hours following acute~     stroke.~   "
262845|NCT00108680|"~     This study will compare the effectiveness of unilateral versus bilateral exercise training~     for recovering movement abilities in chronic stroke patients. After a stroke, some people~     have improved their movement ability by exercising the arm affected by the stroke. Others~     have improved by exercising both arms together. This study will compare these two kinds of~     exercise to see which might work best.~      Healthy volunteers and people who have had a stroke more than 6 months ago may be eligible~     for this study. Stroke patients must have some weakness in their stroke-affected arm. All~     participants must be 18 years of age or older. Candidates are screened with a clinical and~     neurological examination. Women who can become pregnant have a pregnancy test. Stroke~     patients have a magnetic resonance imaging (MRI) study of the brain if they have not had one~     in the last year.~      Participants undergo the following tests and procedures:~      MRI: This procedure uses a magnetic field and radio waves to produce images of body tissues~     and organs. The subject lies on a table that slides into the scanner (a narrow cylinder),~     wearing earplugs to muffle loud knocking sounds that occur during the scanning process. The~     procedure lasts about 45 minutes, during which time the subject must lie still for up to 30~     minutes.~      Testing sessions: There are six test sessions - two to familiarize the subject with the~     reaching test, two to do the reaching test plus transcranial magnetic stimulation (TMS)~     before and after an exercise session, and two to do the reaching test plus TMS one day after~     the exercise session. The sessions are on consecutive days, with a 1-week break after session~     3. The procedures involved are:~        -  Reaching test: The subject responds as quickly as possible to a GO signal presented on~          a computer monitor by performing a reaching movement with his or her arm. The activity~          from the arm muscles is recorded using surface electrodes. During this test, a~          questionnaire is used to determine the subject's attention, fatigue, and mood.~        -  TMS: For this test, a wire coil is held on the scalp, and a brief electrical current is~          passed through the coil, creating a magnetic pulse that stimulates the brain. During the~          stimulation, the subject may be asked to tense certain muscles slightly or perform other~          simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg,~          and the subject may hear a click and feel a pulling sensation on the skin under the~          coil. The effect of TMS on the muscles is detected with small metal disk electrodes~          taped onto the skin of the arms. The subject performs the reaching test while TMS is~          delivered at various times after getting the GO signal.~        -  Arm exercises: The subject is seated in front of an exercise device that has two handles~          that slide forward and backward along a set of tracks. The subject is asked to slide~          either one or both handles back and forth repeatedly, alternating 5 minutes of arm~          exercise with 5 minutes of rest for 30 minutes.~   "
262846|NCT00108667|"~     This study will evaluate the effects of the experimental drug talampanel on dyskinesias~     (involuntary movements) that develop in patients with Parkinson's disease as a result of~     long-term treatment with levodopa (Sinemet). The drug will be tested alone and in combination~     with amantadine-a drug commonly used to alleviate dyskinesias.~      Patients between 21 and 80 years of age with Parkinson's disease and dyskinesias may be~     eligible for this study.~      Screening and baseline evaluation. Participants are evaluated with a medical history,~     physical and neurologic examinations, blood and urine tests, electrocardiogram (EKG) and~     pregnancy test, if applicable. A chest x-ray and MRI or CT scan of the brain are done if~     needed. Patients stop taking all antiparkinsonian medications for one month (2 months if~     taking Selegiline) before the study begins and throughout its duration, except for certain~     medicines allowed, including Sinemet, Mirapex and Requip. Amantadine can be taken up to 1~     week before beginning the study.~      Dose-finding phase. Patients are admitted to the NIH Clinical Center for 2 to 3 days for a~     levodopa dose-finding procedure. For this test, patients stop taking Sinemet and instead~     have it infused through a vein. During the infusions, the drug dose is increased slowly until~     parkinsonian symptoms improve or unacceptable side effects occur or the maximum study dose is~     reached. Symptoms are monitored frequently. At given times during the infusion, saline is~     given instead of Sinemet. The infusions usually begin in the early morning and continue until~     evening. Patients resume taking Sinemet between infusions. (Patients who have had dosing~     infusions in the last 3 months do not have to undergo this phase of the study.)~      After the dose-finding phase, patients are randomly assigned to take placebo (a sugar pill)~     or talampanel. Those taking talampanel also receive amantadine at their usual dosages. At~     some point in the study, amantadine is replaced with placebo. Patients in the talampanel~     group also receive placebo for portions of the study.~      Active study phase. At study weeks 1, 5 and 7, patients are admitted to the Clinical Center~     overnight for a levodopa infusion with talampanel or placebo. The day before the infusion,~     patients have a brief physical examination, blood and urine tests, an EKG, and a review of~     symptoms or changes in their condition. The next day, they receive an infusion of levodopa at~     the dose determined in the dose-finding phase. Then they take a pill containing either~     talampanel or placebo. Their parkinsonian symptoms and dyskinesias are evaluated and~     videotaped every 30 minutes for about 6 hours. Blood is drawn and an EKG is obtained. At the~     end of the infusions and ratings, patients resume their regular Parkinson's medications and~     are given a new supply of study medications to take home.~      At weeks 2, 3, 4 and 6, patients come to the Clinical Center for a review of drug side~     effects. They have blood drawn and receive a new supply of study medications that last until~     the next visit.~      Follow-up. Two weeks after the study ends, patients are contacted by phone for a review of~     side effects or they return to the clinic for an evaluation.~   "
262861|NCT00108446|"~     This study is being done to collect new information on irritable bowel syndrome, a disease~     that causes abdominal pain that does get better with treatment or keeps coming back~     (chronic). To better understand what causes the irritable bowel syndrome, we are studying~     drugs used to treat pain, dextromethorphan, naloxone, fentanyl, and lidocaine. We will study~     the effects these drugs have on experimental pain.~      Dextromethorphan is used in non-prescription cough syrups. Naloxone is used for reversing the~     effects of narcotic pain relievers. Fentanyl is a narcotic used to treat pain and to make a~     person relaxed (sedated) before anesthesia. The purpose of this study is to see what kinds of~     pain are affected by these drugs in persons who have irritable bowel syndrome and persons who~     do not have this problem.~   "
262847|NCT00108654|"~     This study will determine the safety and side effects of an experimental adenoviral vector~     vaccine given to patients who previously received a different HIV vaccine~     (VRC-HIVDNA016-00-VP) in a prior NIAID study. The study will also monitor participants for~     the social impact of being in an HIV vaccine study (e.g., problems with insurance, health~     care, friends, family, employment, housing, and so forth). The study vaccine is made using an~     adenovirus (a common virus that causes upper respiratory infections, such as the common cold,~     eye infection, urine infection or diarrhea) that has been modified to contain DNA that codes~     for three HIV proteins. The modified virus cannot reproduce in the body and cannot cause HIV~     disease or adenoviral infections.~      Healthy volunteers who previously received three injections of the VRC-HIVDNA016-00-VP under~     the NIAID study VRC 007 (protocol 04-I-0254) may be eligible for this study.~      Participants receive one injection of the adenoviral vector vaccine. It is given the day they~     enroll in the study, as a single injection in an upper arm muscle. Also on that day they have~     a brief physical examination, medical history, blood and urine tests, pregnancy test for~     women, and counseling, as needed, about HIV and pregnancy avoidance. Subjects are observed~     for side effects for at least 30 minutes after the vaccination and are required to telephone~     the clinic staff 1 to 2 days after the injection for follow-up. In addition, they are given a~     diary card to take home, on which they record their temperature and any symptoms daily for 5~     days.~      Subjects return to the clinic for 5 follow-up visits at weeks 2, 4, 6, 12 and 24 after the~     injection. At each visit they are checked for health changes or problems since the last~     visit, asked how they are feeling and what medications they are taking. They have blood drawn~     at every visit and urine samples collected at most visits. They are tested for HIV three or~     more times and are questioned about their sexual behavior and drug use. They also complete a~     social impact questionnaire at the last visit.~      Subjects are asked to undergo apheresis at the week 4 visit. This procedure allows collection~     of a larger number of white blood cells than can be obtained by a simple blood draw. The~     white cells are studied to see how the immune system responds to the study vaccine. For~     apheresis, blood is collected through a needle in an arm vein and spun in a machine that~     separates the components. The white blood cells are extracted and the rest of the blood is~     returned to the body through the same needle. Subjects who do not undergo apheresis have~     about 1/3 cup of blood sample drawn using a needle.~   "
262848|NCT00108628|"~     The purpose of this study is to compare the effectiveness of two cognitive behavioral group~     psychotherapy interventions in controlling the subjective sleep disturbance in veterans with~     Post-traumatic Stress Disorder.~   "
262849|NCT00108615|"~     Subjects with impaired glucose tolerance will be randomized to receive pioglitazone or~     metformin for 10 weeks. Measurements of insulin sensitivity, body composition, glucose~     tolerance, and muscle lipid accumulation will be performed. Adipose tissue and muscle~     biopsies are performed. The goal of the study is to determine whether the lipotoxiciy of~     impaired glucose tolerance is ameliorated by pioglitazone.~   "
262850|NCT00108602|"~     This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in~     selected patients with stroke. We will select a subset of patients with stroke in the prior 3~     months who are most likely to have ventilatory instability as a cause of the upper airway~     obstruction as indicated by the absence of obesity, an abnormal hypocapnic apnea threshold~     and resolution of obstructive apnea during CO2 administration. Following baseline~     polysomnography, patients will be randomly assigned to acetazolamide (250 mg hs [at bedtime])~     versus placebo for 7 days. Polysomnography will be repeated and then subjects will cross-over~     therapies for another 7 days followed by a final nocturnal polysomnography.~   "
262851|NCT00108589|"~     The purpose of this study is to examine the effect of S-adenosylmethionine therapy in those~     patients with non-alcoholic liver disease in the form of steatohepatitis (NASH). This will be~     accomplished by development of a database of these patients, all of whom will have biopsy~     documented NASH. A placebo controlled trial will then examine the effect of~     S-adenosylmethionine over time on clinical outcome in these patients. It is expected that~     this agent will slow or halt the progression of this disease.~   "
262852|NCT00108576|"~     The purposes of this study are:~        -  To study the efficacy of divalproex in the treatment of PTSD;~        -  To study the plasma GABA (gamma aminobutyric acid) levels before and after treatment~          with divalproex in PTSD.~   "
262853|NCT00108563|"~     The purpose of this study is to learn more about the effects of interferon and ribavirin~     combination therapy in people with Hepatitis C. The specific aims are:~        -  To assess how often depressive symptoms occur in patients taking combination alpha~          interferon plus ribavirin or pegylated interferon plus ribavirin therapy for Hepatitis~          C, when depressive symptoms occur, and how severe the depressive symptoms are when they~          do occur;~        -  To identify potential predictors for the development of depressive symptoms;~        -  To identify if citalopram, an antidepressant medication, can prevent or lessen the~          severity of depressive symptoms brought about by interferon therapy.~   "
262854|NCT00108550|"~     The purpose of this study is to determine whether gabapentin is efficacious as an analgesic~     for chronic low back pain.~   "
262855|NCT00108537|"~     The primary objective of this study is to determine which is the better approach to smoking~     cessation in veterans: bupropion combined with transdermal nicotine or high dose nicotine~     replacement therapy (NRT) using transdermal nicotine combined with nicotine inhaler.~   "
262856|NCT00108524|"~     This study compares two types of diet interventions: a low carbohydrate ketogenic diet~     (Atkins) and a low-fat diet combined with a medication (Orlistat).~   "
262857|NCT00108511|"~     The purpose of this study is to examine the role of glycosylphosphatidylinositol-specific~     phospholipase D (GPI-PLD) in triglyceride metabolism.~   "
262858|NCT00108498|"~     This study will determine if mirtazapine, a unique antidepressant that does not disturb~     sleep, will improve obstructive sleep apnea (OSA). The design is randomized, crossover,~     double blind, and placebo controlled. On two consecutive nights of one week, the patients~     receive either 30 mg mirtazapine or placebo at bedtime. The following week, the alternative~     medication is administered. The patients have known mild to moderate sleep apnea. The~     endpoints of the study are the apnea + hypopnea index (AHI), sleep quality, and the degree of~     arterial oxygen desaturation.~   "
262859|NCT00108485|"~     The primary purpose of this study is to test the effectiveness and tolerability of Niaspan®~     to improve the levels of blood fats (good and bad cholesterol and triglyceride levels) in~     people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan®~     slows down further development of kidney damage.~   "
262860|NCT00108459|"~     This study is designed to address the hypothesis that in obese patients with type 2 diabetes~     mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to~     low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body~     weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental~     effects on serum lipid concentrations.~   "
262862|NCT00108433|"~     This study will treat hemodialysis patients who have a central catheter that is thought to be~     infected with a specific bacteria (Gram positive bacteria).~   "
262863|NCT00108420|"~     The purpose of this study is to determine whether prazosin will reduce the incidence of~     nightmares, sleep disturbance, and overall symptoms in combat trauma-exposed individuals with~     PTSD.~   "
262867|NCT00108368|"~     The goal of this research is to find ways to maximize the benefits of antipsychotic~     medications for cognition.~      Hypothesis: Risperidone and olanzapine will show greater benefits than conventional~     medications on assessments of social cognition, particularly affect perception and social~     perception.~   "
262868|NCT00108355|"~     This clinical trial compares a combination of two drugs that constrict blood vessels~     (Octreotide LAR and Midodrine) to albumin after large volume paracentesis. Subjects have~     cirrhosis and ascites.~   "
262869|NCT00108342|"~     The purpose of this study is to determine whether sampling nicotine replacement treatments~     (NRTs) is superior to learning about them by computer. Testing also covers preferences among~     the treatments. Subjects will be enrolled veterans who smoke.~      Hypothesis: Direct experience (sampling) of NRTs will increase knowledge about NRTs,~     motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by~     computer.~   "
262870|NCT00108329|"~     This study examines the effects of weight loss and aerobic exercise training on sugar~     metabolism and other risk factors for heart disease in obese older individuals.~   "
262871|NCT00108316|"~     This study is designed to understand if a biological measurement, of how platelets respond to~     serotonin (a chemical in the blood sometimes referred to as SERT), can provide information~     that will determine an ideal dose, one specifically tailored for each individual's~     chemistry. The biological measurement will be obtained by testing a blood sample. There will~     be approximately 120 control subjects expected for enrollment.~   "
262872|NCT00108303|"~     Schizophrenia has long been known to be an illness with significant evidence for a genetic~     predisposition. The purpose of this study is to determine the genetic abnormalities that~     cause childhood and adult onset schizophrenia.~   "
262873|NCT00108290|"~     In men with prostate cancer who do not have evidence of spread to bone or other sites on~     computed axial tomography (CAT) scan/bone scan but are still at significant risk of failing~     treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy~     is being given for 6 months followed by surgery to remove the prostate.~   "
262874|NCT00108277|"~     This study will explore respiratory dysregulation in anxious outpatients and examine the~     effect of breathing training with biofeedback for those anxious patients.~   "
262875|NCT00108264|"~     The purpose of this study is to use dendritic cells transfected with amplified RNA from~     autologous tumor cells to develop a vaccine strategy for the treatment of prostate cancer in~     patients with disseminated disease.~   "
262876|NCT00108251|"~     The primary purpose of this study is to determine whether eplerenone has a beneficial effect~     on improving exercise ability in patients with diastolic heart failure.~   "
262877|NCT00108238|"~     Healthy postmenopausal women not currently taking hormone replacement or hormone modulating~     therapy take a 3-month course of estradiol/raloxifene/placebo to evaluate the effects of each~     on vascular function, as indicated by PET coronary flow reserve studies and brachial artery~     ultrasound, before and after use of the therapies. This is a randomized, placebo-controlled,~     blinded study.~   "
262878|NCT00108225|"~     In this study we tested the hypothesis that an increase in protein content of the diet will~     result in an increase in the 24-hour integrated circulating growth hormone (GH) and~     insulin-like growth factor-1 (IGF-1) concentrations and an increase in lean body mass in~     people with untreated type 2 diabetes.~   "
262879|NCT00108212|"~     The purpose of this study is to evaluate different diets and the effects of blood measures or~     inflammation and endothelial function in association with genetics tending to abnormal blood~     test levels.~   "
262880|NCT00108199|"~     This study examines whether patients with schizophrenia can benefit from a problem-solving~     training intervention and whether a work-related social skills training intervention leads to~     improvements in the patient's performance at work.~   "
262881|NCT00108186|"~     This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T~     regulatory cell activities and thus augment immune responses against lung cancer. The broad~     goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non~     small cell lung cancer in an effort to foster an informed approach for the use of COX-2~     inhibitors in prevention and therapy for lung cancer.~   "
262882|NCT00108173|"~     The purpose of the study was to determine how the treatments for cigarette craving work.~      Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater~     reductions in regional brain activation from before to after both forms of active treatments~     than from before to after placebo.~   "
262883|NCT00108160|"~     The purpose of this study is to determine if mupirocin 2% in polyethylene glycol (PEG)~     ointment [Treatment Arm] is effective in preventing moderate to severe re-infection with~     Staphylococcus aureus compared with treatment with polyethylene glycol (PEG) ointment~     [Placebo Arm].~   "
262884|NCT00108147|"~     The goal of this study is to determine the effect of a functional circuit training program as~     compared to standard cardiac rehabilitation or control exercise in improving physical~     function and activity.~   "
262885|NCT00108134|"~     The purpose of this study is to determine whether topical application of PEP005 is safe for~     the treatment of superficial basal cell carcinoma.~   "
262886|NCT00108121|"~     The purpose of this study is to determine whether topical application of PEP005 is safe for~     the treatment of nodular basal cell carcinoma.~   "
262887|NCT00108108|"~     The purpose of this study is to determine the highest tolerated dose, safety and activity of~     HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior~     treatment.~   "
262888|NCT00108095|"~     This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both~     safety and effectiveness in prevention PONV~   "
262903|NCT00107900|"~     Patients who undergo total hip replacement surgery are at greater risk of getting deep vein~     thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of~     the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients~     having total hip replacement surgery.~   "
262904|NCT00107887|"~     The purpose of this study is to determine if implementing a policy of widespread INH~     (Isoniazid) prophylaxis therapy in HIV-infected patients with access to antiretroviral~     therapy reduces the incidence of active TB disease in the HIV clinic population.~   "
262889|NCT00108082|"~     This study is designed to compare the effects of COREG MR (carvedilol modified release~     formulation) to atenolol on indices of left ventricular dimensions when added to standardized~     angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone.~     Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The~     primary endpoint will be the change in left ventricular mass index (LVMI) characterized by~     magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints~     include the change in LV (left ventricular) mass, LV wall thickness, diastolic left~     ventricular filling parameters, and left ventricular ejection fraction by echocardiographic~     methods at Treatment Month 12. Composite outcomes and individual event data will also be~     evaluated by treatment group.~   "
262890|NCT00108069|"~     This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth~     in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering~     with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with~     tumor growth processes. Laboratory studies show that low doses of bortezomib significantly~     enhance glioma cell death when used with tamoxifen.~      Patients 18 years of age and older with glioma whose tumor does not respond to standard~     medical treatment and who are not taking enzyme-inducing anti-seizure medications such as~     Dilantin, phenobarbitol, or Tegretol, may be eligible for this study. Candidates are screened~     with a physical examination, blood tests, and magnetic resonance imaging (MRI) or computed~     tomography (CT). MRI and CT scans produce images of the brain that can show if the brain~     tumor is growing (see below).~      Participants receive treatment in 6-week cycles for up to 1 year. (The treatment duration may~     be extended in some patients who continue to tolerate the drug and show no signs of tumor~     growth after 1 year.) During each cycle, patients take six tamoxifen tablets twice a day~     every day and receive bortezomib by infusion into a vein on days 3, 6, 10, 13, 24, 27, 31 and~     34. Treatment may continue as long as the tumor does not grow and the patient does not~     develop unacceptable side effects. In addition to drug treatment, patients undergo the~     following tests and procedures:~        -  Periodic routine blood tests.~        -  MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and~          radio waves to produce images of body tissues and organs. CT uses x-rays to provide~          3-dimensional views of the part of the body being studied. For both procedures, the~          patient lies on a table that slides into the cylindrical scanner.~        -  Blood test to measure levels of bortezomib. Blood is drawn before the bortezomib~          infusion on days 3 and 24, and 4 hours after the infusion on day 24 of the first~          treatment cycle only.~        -  Dynamic MRI with spectroscopy or positron emission tomography (PET). Patients may be~          asked to undergo one of these tests, which help distinguish live tumor from dying tumor.~          The experience of dynamic MRI with spectroscopy is the same as standard MRI and is done~          at the same time as the standard procedure (see above). PET uses a radioactive substance~          to show cellular activity in specific tissues of the body. The patient is given an~          injection of a sugar solution in which a radioactive isotope has been attached to the~          sugar molecule. A special camera detects the radiation emitted by the radioisotope, and~          the resulting images show how much glucose is being used in various parts of the body.~          Because rapidly growing cells, such as tumors, take up and use more glucose than normal~          cells do, this test can be used to show active tumors.~        -  Drug diary. Patients maintain a calendar to record when they take their study drugs and~          what side effects they develop.~   "
262891|NCT00108056|"~     This study will examine the safety of a twice-a-day dosing regimen of the experimental drug~     Enzastaurin in patients with malignant glioma (a cancerous brain tumor) who are and who are~     not taking certain anti-seizure medicines. Enzastaurin may prevent the formation of new blood~     vessels that tumors need to grow. It has shown some effect against brain tumors in animals~     and in some patients with recurrent gliomas. This study will see if the drug can help~     patients with gliomas and how much drug they should be given.~      Patients 18 years of age and older with malignant glioma that has recurred after standard~     therapy may be eligible for this study. Candidates are screened with a physical examination,~     blood and urine tests, magnetic resonance imaging (MRI) or computed tomography (CT) scans,~     and an electrocardiogram.~      Participants are divided into two groups of patients-those who are and those who are not~     taking certain anti-seizure medications-in order to determine if the anti-seizure medication~     alters the way the body handles Enzastaurin. Patients in both groups are further divided into~     different dosing regimens: some in each group take Enzastaurin once a day for 3 weeks,~     followed by twice a day for 3 weeks; others in the group take the drug twice a day for 3~     weeks followed by once a day for 3 weeks. The medication is taken by mouth every day.~     Treatment is given in 6-week cycles and may continue for 1 year unless the tumor grows or the~     patient develops unacceptable drug side effects. In addition to drug treatment, patients have~     the following tests and procedures:~        -  Medical history, physical, and neurological examinations every 3 weeks during the first~          cycle and then every 6 weeks.~        -  MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and~          radio waves to produce images of body tissues and organs. CT uses x-rays to provide~          3-dimensional views of the part of the body being studied. For both procedures, the~          patient lies on a table that slides into the cylindrical scanner.~        -  Routine blood tests every week during the first cycle and every 3 weeks after that.~        -  Electrocardiogram on days 21 and 42 of the first cycle, just before taking the drug and~          30 minutes and 4 hours after taking the drug.~        -  Pharmacokinetic studies within 3 days of day 21 of the first cycle. Several blood~          samples are drawn to measure levels of Enzastaurin. Patients taking the drug once a day~          have blood samples drawn before the morning dose and 1, 2, 4, 6 and 24 hours after the~          dose. Patients taking the drug twice a day have samples drawn before the morning dose,~          at 1, 2, 4, 6 and 12 hours after the dose, and then 12 hours after the evening dose. In~          addition, on day 1 an extra tube of blood is drawn at the time of the Enzastaurin dose~          and 4 hours later.~        -  Dynamic MRI with spectroscopy or PET. These tests are done to help distinguish live~          tumor from dying tumor. The experience of dynamic MRI with spectroscopy is the same as~          standard MRI and is done at the same time as the standard procedure. PET uses a~          radioactive substance to show cellular activity in specific tissues of the body. The~          patient is given an injection of a sugar solution in which a radioactive isotope has~          been attached to the sugar molecule. A special camera detects the radiation emitted by~          the radioisotope, and the resulting images show how much glucose is being used in~          various parts of the body. Because rapidly growing cells, such as tumors, take up and~          use more glucose than normal cells do, this test can be used to show active tumors.~   "
262892|NCT00108043|"~     Objective:~      The objective of this research is to undertake a safety and viability study of FES-evoked~     stepping in individuals with paraplegia. The rationale for this objective is based upon the~     need to clarify whether physiological limitations, especially orthostatic intolerance, limit~     functional mobility outcomes. The cardiovascular, autonomic, and muscle metabolic factors~     governing orthostatic tolerance during skin-surface FES stepping will be investigated, since~     this functional task forms the basis of upright mobility and engenders strong physiological~     challenges upon key regulatory processes in the SCI (spinal cord injury) patient.~      Specific Hypotheses:~      i. Reduction of blood pressure will be greater during FES-evoked stepping than during passive~     stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no~     upper body component versus FES-stepping with an upper body component; iii. Blood pressure~     will be reduced even further during FES-evoked stepping following a 6-week~     progressive-intensity gait training intervention.~   "
262893|NCT00108030|"~     The specific aim of this project is to improve walking ability in persons following stroke~     using 'treadmill training plus power training'. This modality addresses the two major~     impairments followings stroke: weakness and incoordination, as well as loss of fitness.~     Importantly, this training will be presented at higher intensity and greater volume than is~     currently received. Furthermore, to ensure that persons continue to maintain the level of~     improvement from an intensive exercise program, we will also implement a behavioral change~     for long-term maintenance of exercise behavior in a less supervised environment. A randomized~     controlled clinical trial will be conducted in 102 sub-acute stroke patients to ascertain the~     efficacy of this approach to improving walking ability.~      Hypotheses:~        1. Walking endurance will be increased to a greater degree in a patient group receiving~          treadmill plus muscle power training compared with a treadmill training only group, or~          'usual care' group.~        2. Gait stability, muscle function, aerobic fitness and balance will improve more in a~          group receiving treadmill plus muscle power training, than either those in treadmill~          training or usual care patient groups.~        3. Habitual activity levels will be higher in the group receiving treadmill plus muscle~          power training compared with a treadmill training only group or 'usual care' group.~        4. The change in 6-minute walk distance will be positively related to changes in muscle~          power, strength and endurance, aerobic fitness, gait mechanics, and balance.~        5. Baseline depression and low self-efficacy will be associated with less robust~          adaptations to all types of training and lower rates of long-term compliance to the~          exercise prescription in the experimental groups.~   "
262894|NCT00108017|"~     This study is comparing 2 medications for glaucoma and how effective they are at controlling~     glaucoma over the course of an entire day.~   "
262895|NCT00108004|"~     This open-label, multicenter study is designed to investigate the clinical utility and safety~     of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to~     achieve the desired level of glycemic control using insulin therapy.~   "
262896|NCT00107991|"~     This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been~     approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate~     to severe plaque psoriasis (PsO), for use in reducing the signs and symptoms of moderately to~     severely active rheumatoid arthritis (RA) in adults and children, and psoriatic arthritis~     (PsA) and ankylosing spondylitis (AS) in adults. It is available by prescription for the~     treatment of PsO, RA, PsA, and AS. Etanercept is approved for injection under the skin at a~     dose of 50 mg per week in patients with psoriasis.~      The purpose of this study is to determine whether etanercept is safe and effective for the~     treatment of hidradenitis. Another purpose of this study is to determine the impact of~     etanercept treatment of hidradenitis on skin related to quality of life.~      The skin lesions typically associated with hidradenitis are thought to be partly due to a~     blockage that occurs in sweat glands, called apocrine ducts, which become inflamed and~     eventually destroyed. A protein found in the body called tumor necrosis factor alpha, or TNF-~     α, is a hormone that causes this inflammation or swelling. The study drug, etanercept, blocks~     the action of TNF- α. By blocking the action of TNF-α, etanercept may provide a reduction in~     the signs and symptoms of hidradenitis.~      This study will take place at the University of Pennsylvania and will involve up to 21~     participants ages 18 and up. Approximately 21 subjects will participate at the University of~     Pennsylvania.~      Each patient will participate in this study for a maximum of 6 months. The study consists of~     a screening visit, baseline assessment visit (Day 1), a treatment period (Week 2 - Week 14),~     and a one month follow-up visit (Week 18 visit). The total duration of the study will be~     approximately 2 years.~   "
262897|NCT00107978|"~     Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug,~     telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin~     structure infections.~   "
262898|NCT00107965|"~     The purpose of this study is to determine whether topical application of PEP005 is safe for~     the treatment of actinic keratoses.~   "
262899|NCT00107952|"~     Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug,~     telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.~   "
262900|NCT00107939|"~     The purpose of this study is to evaluate the effectiveness and tolerability of an~     investigational drug for the treatment of manic episodes of bipolar disorder. The~     investigational drug will be given as additional therapy to one of the five following~     medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These~     medications are already FDA (Food and Drug Administration)-approved treatments for mania.~   "
262901|NCT00107926|"~     The purpose of this study is to evaluate the effectiveness and tolerability of an~     investigational drug for the treatment of manic episodes of bipolar disorder. The~     investigational drug will be given as additional treatment with either lithium or valproate,~     which are already FDA (Food and Drug Administration)-approved treatments for mania.~   "
262902|NCT00107913|"~     This study is designed to evaluate the efficacy and safety of single agent Doxil in the~     treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).~   "
262905|NCT00107874|"~     Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and~     mortality, both in developed and developing countries.~      With this trial, we sought to determine the effectiveness of oral misoprostol as an~     uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH~     undergoing non-scheduled Cesarean section.~      We therefore compared the intra- and postoperative blood loss, as well as drug related side~     effects in patients, treated by the same surgical and anesthesiological team in one~     institution.~   "
262906|NCT00107861|"~     This study will be conducted in subjects with refractory colorectal carcinoma with~     unresectable liver metastases. The purposes of the study are:~        -  to evaluate the safety and any harmful effects of an intravenous injection of Ad.hIFN-β;~        -  help determine whether the virus carrying the interferon-beta gene will enter the~          bloodstream and liver tumor cells and cause the cancer cells to die.~   "
262907|NCT00107848|"~     The primary objective of the study is to evaluate the safety and tolerability of treatment~     with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with~     narcolepsy or OSAHS (obstructive sleep apnea/hypopnea), when administered for up to 12~     months. Safety and tolerability will be evaluated throughout the study by means of adverse~     event information, clinical laboratory test results, vital signs measurements, and body~     weight and height measurements; quarterly physical examination findings; and 12 lead~     electrocardiograph (ECG) evaluations at the end of the study. In addition, the cognitive and~     behavioral effects of PROVIGIL will be assessed quarterly as measured by the Child Behavior~     Checklist for Ages 6-18 (CBCL/6-18), a brief psychiatric interview, and the Kaufman Brief~     Intelligence Test (KBIT 2).~   "
262908|NCT00107835|"~     The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin~     numbing cream) applied on healthy skin before a painful dermatologic procedure in adults.~     This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.~   "
262909|NCT00107822|"~     The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin~     numbing cream) applied on healthy skin before a painful dermatologic procedure in children.~     This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.~   "
262910|NCT00107809|"~     The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment,~     compared to placebo treatment, in children and adolescents with excessive sleepiness (ES)~     associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), as assessed by:~        -  mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps~          performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6~          or early termination)~        -  the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post~          baseline observation (week 6 or early termination).~   "
262911|NCT00107796|"~     Primary Objectives: The primary objectives of the study are to determine the effectiveness of~     PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive~     sleepiness (ES) associated with narcolepsy, as assessed by:~        -  mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps~          performed at 0900, 1100, 1300, and 1500) at the last post-baseline observation (week 6~          or early termination)~        -  the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last~          post-baseline observation (week 6 or early termination).~   "
262912|NCT00107783|"~     This 3-year study will examine the safety and effectiveness of long-term use of nitisinone~     (Orfadin) for treating joint problems in patients with alkaptonuria, an inherited disease in~     which a compound called homogentisic acid accumulates. The excess homogentisic acid causes~     arthritis and limited joint movement. It can also cause heart valve damage and kidney stones.~      Patients between 30 and 80 years of age with alkaptonuria may be eligible for this study.~     Patients must have hip involvement, but at least one remaining hip joint. Candidates are~     recruited from among patients enrolled in protocol 00-HG-0141, Clinical, Biochemical, and~     Molecular Investigations into Alkaptonuria. Participants may enter both protocols~     simultaneously.~      Participants are randomly assigned to one of two treatment groups: one group takes their~     regular medicines plus a 2-mg nitisinone capsule daily; the other group takes only their~     regular medicines. Patients taking nitisinone have blood tests to measure liver function 2~     weeks and 6 weeks after starting treatment. Before starting therapy, all patients are~     admitted to the NIH Clinical Center for 4-5 days to undergo the following procedures:~        -  Medical history and physical examination~        -  24-hour urine collection to test for sugar, protein, and other molecules~        -  Blood tests for liver and thyroid function, blood counts, and blood chemistries~        -  Blood and urine tests to measure tyrosine and other amino acids and homogentisic acid~        -  Bone x-rays~        -  Spiral CT (computed tomography) of the abdomen to detect kidney stones~        -  Eye examination and evaluations by specialists in rehabilitation medicine and pain, plus~          other consults in skin, brain, lung, heart, and kidney, as needed~      All patients, whether or not they receive nitisinone, return to the Clinical Center for a 2-3~     day follow-up admission every 4 months for a history and physical examination, blood tests,~     and two 24-hour urine collections. Every 12 months (12, 24 and 36 months after starting the~     study), patients also have repeat bone x-rays, spiral CT, kidney ultrasound, echocardiogram,~     and electrocardiogram. An MRI of the brain is done at the end of the study.~      Sixteen months after the end of the study enrollment period, the treated and non-treated~     groups are evaluated. If nitisinone has delayed the progression of joint disease in the~     treated group, the study continues and all patients receive the drug for the remainder of the~     study. If not, the study continues for another 20 months, at which time the study ends and~     the evaluation process is repeated.~      Patients who develop symptoms such as corneal crystals, pain, or severe liver or nervous~     system toxicity may be taken off the study.~   "
262913|NCT00107770|"~     The purpose of the study is to evaluate the safety of sodium phenylbutyrate (NaPB) treatment~     in subjects with amyotrophic lateral sclerosis (ALS) and the ability to take this medication~     without major side effects.~   "
262914|NCT00107757|"~     The purpose of this study is to determine if the investigational drug is effective and safe~     in children with seasonal allergic rhinitis.~   "
262915|NCT00107744|"~     The purpose of this randomized, double-blind, controlled trial is to examine the effect of~     soybean protein supplementation on blood pressure in persons with prehypertension or stage-1~     hypertension.~   "
262916|NCT00107731|"~     The purpose of this study is to determine whether quetiapine when used as adjunct to lithium~     or divalproex is safe and effective in the maintenance treatment of adult patients with~     Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment~     Phase and the Randomized treatment Phase.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
262917|NCT00107718|"~     This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of~     SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in~     subjects with previously untreated metastatic melanoma.~   "
262973|NCT00106899|"~     The purpose of this study is to examine how brain imaging technology can be used with other~     tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's~     disease (AD). This information will aid future clinical trials by providing a standard~     assessment tool to measure the effects of treatments being studied.~   "
262918|NCT00107705|"~     The purpose of this study is to evaluate the residual allergenicity of Tree MATA (modified~     pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of~     the wheal response after skin prick testing with aqueous native and modified allergen,~     modified tyrosine adsorbed allergen and Tree MATA MPL (modified tyrosine adsorbed + MPL~     [Monophosphoryl Lipid A]).~   "
262919|NCT00107692|"~     The purpose of this study, and its original contribution to research, is to determine the~     impact of a physical activity skill development and parent centered family weight management~     program on the weight, cardiovascular health, physical activity, dietary intake and sedentary~     behaviors of overweight and obese children.~   "
262920|NCT00107679|"~     The purpose of this study is to compare the development of abnormal cell growth or cancer in~     the anal region of individuals who are receiving one of two different anti-HIV treatment~     strategies.~   "
262921|NCT00107666|"~     Over 500,000 patients undergo cardiac surgery with CPB in the United States annually.~     Although mortality rates have decreased with advances in perioperative care, many patients~     are affected by postoperative organ dysfunction. The incidence of complications may exceed~     30%. It has been speculated that an exaggerated inflammatory response to surgical trauma and~     the CPB machine are likely causes for this morbidity. Factors predisposing organ dysfunction~     include tissue injury, endotoxemia, and oxidative stress. High risk patients can be~     identified preoperatively through the validated Parsonnet Additive Risk Score. CTI-01 has~     demonstrated potent anti-inflammatory and tissue protection activity in multiple animal~     models of disease including pancreatitis, ischemia-reperfusion injury, sepsis, renal injury,~     and endotoxemia. These findings support its clinical use in critical care medicine including~     cardiac surgery. Patients will receive a total of six doses, administered intravenously just~     prior to and after surgery.~   "
262922|NCT00107653|"~     This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc~     weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus~     non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on~     study treatment is 3-12 months and the target sample size is 500+ patients.~   "
262923|NCT00107640|"~     Older adults become more sensitive to alcohol, and alcohol also interacts adversely with~     their common medical conditions and medications. The aim of Project SHARE (Senior Health and~     Alcohol Risk Education) is to see whether patient and provider education can decrease risky~     alcohol use and reduce health care costs in persons 60 years of age and older.~   "
262924|NCT00107627|"~     The Skin Incision Study evaluates the efficacy of skin closure methods: skin staples and~     subcuticular sutures at 6 weeks and at 3 months following the operation by measuring cosmesis~     and pain.~   "
262925|NCT00107614|"~     The purpose of this study is to find out what the response is and the side effects are with~     chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide,~     cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two~     autologous transplants.~   "
262926|NCT00107601|"~     Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study~     will compare the effects of two regimens of insulin therapy, respectively titrated to achieve~     a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between~     7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively).~      This project aims at defining whether a tight glucose control by insulin improves the vital~     outcome in a mixed population of critically ill patients (around 3000 patients).~      Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays~     in the Intensive Care Unit (ICU) and in the hospital, length of ICU stay without life-support~     therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ~     failures, and number of red-cell transfusions.~   "
262927|NCT00107588|"~     The goal of this research is to improve treatment outcome for marijuana-dependent~     individuals. The current study builds on the findings of our prior NIDA-funded marijuana~     treatment study in which improved client outcomes were associated with greater treatment~     attendance, greater client self-efficacy, and greater use of coping skills. We will use a~     contingency management paradigm to provide tangible reinforcement for completing homework~     assignments that are designed to enhance coping skills. It is anticipated that this will~     result in greater homework compliance, leading to greater self-efficacy regarding one's~     ability to cope with high-risk situations. Improved self-efficacy will enhance the likelihood~     of employing coping skills in high-risk situations, thereby increasing the probability of~     achieving and maintaining abstinence.~   "
262928|NCT00107575|"~     To test the effectiveness of an smoking cessation treatment for smokers who also drink~     alcohol heavily.~   "
262929|NCT00107562|"~     Social networks are thought to hold the potential for shaping behavior on the grounds that~     social and situational factors more strongly influence behavior than do personality~     variables. This is a behavioral intervention study that will test a 6-session, small-group,~     peer-network intervention among adolescent males and females and their friends. The~     intervention primarily focuses on reducing risky sexual behavior and increasing condom use~     among adolescent males and females, aged 16-19. The concurrent use of alcohol and marijuana~     during sex is also a focus as these two substances are widely used among adolescents and fuel~     risky sexual behavior.~   "
262930|NCT00107549|"~     The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV~     infected young adults on stable anti-HIV therapy.~   "
262931|NCT00107536|"~     Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works~     in treating patients with unresectable liver or biliary tract cancer~   "
262932|NCT00107523|"~     RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Pravastatin may help idarubicin and cytarabine work better by making cancer cells~     more sensitive to the drugs. Giving pravastatin together with idarubicin and cytarabine may~     kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of pravastatin when~     given together with idarubicin and cytarabine in treating patients with acute myeloid~     leukemia.~   "
263202|NCT00103766|"~     The purpose of this study is to assess the benefit to patients with empyema or complicated~     parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two~     different dose strategies compared with saline placebo.~   "
262933|NCT00107510|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of~     immune cells found in bone marrow or peripheral blood and may help the immune system recover~     from the side effects of chemotherapy. Giving docetaxel and carboplatin together with~     pegfilgrastim before surgery may shrink the tumor so that it can be removed.~      PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together~     with pegfilgrastim works in treating patients who are undergoing surgery for stage II or~     stage III breast cancer.~   "
262934|NCT00107497|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy in different ways and giving it after surgery may kill any tumor cells that remain~     after surgery.~      PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it~     works in treating women with localized breast cancer.~   "
262935|NCT00107484|"~     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) using~     ferumoxtran-10, may help find and diagnose breast cancer that may have spread to the axillary~     lymph nodes and may help in planning breast cancer treatment.~      PURPOSE: This phase II trial is studying how well MRI using ferumoxtran-10 works in finding~     metastases to the axillary lymph nodes in patients with invasive breast cancer.~   "
262936|NCT00107471|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in~     bone marrow or peripheral blood and may help the immune system recover from the side effects~     of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Topotecan may~     make tumor cells more sensitive to radiation therapy . Giving topotecan and G-CSF together~     with radiation therapy may be an effective treatment for brain stem glioma.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when~     given together with G-CSF and radiation therapy and to see how well they work in treating~     young patients with newly diagnosed brain stem glioma.~   "
262937|NCT00107458|"~     RATIONALE: Drugs used in chemotherapy, such as valproic acid, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Valproic acid may also stop the growth of solid tumors or CNS tumors by blocking blood flow~     to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of valproic acid in~     treating patients with recurrent or refractory solid tumors or CNS tumors.~   "
262938|NCT00107445|"~     This phase II trial is studying how well EF5 works in finding oxygen in tumor cells of~     patients who are undergoing surgery or biopsy for cervical, endometrial, or ovarian~     epithelial cancer. Diagnostic procedures using the drug EF5 to find oxygen in tumor cells may~     help in planning cancer treatment~   "
262939|NCT00107432|"~     This phase II trial is studying how well sorafenib works in treating patients with malignant~     mesothelioma. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor.~   "
262940|NCT00107419|"~     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating~     patients with recurrent and unresectable or metastatic chondrosarcoma.~   "
262941|NCT00107393|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving trastuzumab together with capecitabine may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving trastuzumab together with~     capecitabine works in treating women with metastatic breast cancer.~   "
262942|NCT00107380|"~     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find~     cancer cells and carry cancer-killing substances to them without harming normal cells.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as~     cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving a radiolabeled monoclonal antibody together with rituximab and combination~     chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving iodine I 131 tositumomab together~     with rituximab and combination chemotherapy works in treating older patients with stage II,~     stage III, or stage IV B-cell non-Hodgkin's lymphoma.~   "
262943|NCT00107367|"~     RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a~     tumor was surgically removed may kill any remaining tumor cells and cause less damage to~     normal tissue.~      PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in~     treating patients who are undergoing surgery to remove a metastatic brain tumor.~   "
262944|NCT00107354|"~     RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the~     immune system in different ways and stop cancer cells from growing.~      PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy~     in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or~     myelodysplastic syndromes that relapsed after donor stem cell transplant.~   "
262945|NCT00107341|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving bortezomib together with paclitaxel and carboplatin may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with paclitaxel~     and carboplatin works in treating patients with unresectable, metastatic cancer of the~     esophagus or gastroesophageal junction.~   "
263279|NCT00102687|"~     The purpose of this study is to determine if azacitidine, combined with Best Supportive Care~     (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a~     different doses and dosing schedules.~   "
262946|NCT00107315|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the~     growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as capecitabine, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving bevacizumab together with~     capecitabine may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with~     capecitabine works as first-line therapy in treating older patients with metastatic~     colorectal cancer.~   "
262947|NCT00107289|"~     The purpose of this research study is to find how active and safe 131 I-MIBG is in patients~     with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.~   "
262948|NCT00107276|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one chemotherapy drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with~     capecitabine works in treating women with stage IV breast cancer.~   "
262949|NCT00107263|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by lowering the amount of estrogen the body makes.~     Zoledronate may prevent bone loss in patients who are receiving letrozole. It is not yet~     known which schedule of zoledronate is more effective in preventing bone loss in patients~     with breast cancer.~      PURPOSE: This randomized phase III trial is studying two different schedules of zoledronate~     to compare how well they work in preventing bone loss in postmenopausal women who are~     receiving letrozole for stage I, stage II, or stage IIIA breast cancer.~   "
262950|NCT00107250|"~     RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as~     paclitaxel, carboplatin, or capecitabine, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving AZD2171 together~     with chemotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of AZD2171 when given~     together with chemotherapy in treating patients with advanced non-small cell lung cancer~     (closed to enrollment as of 8/9/07), colorectal cancer, or other cancer suitable to~     capecitabine treatment.~   "
262951|NCT00107237|"~     RATIONALE: AEE788 and everolimus may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving AEE788~     together with everolimus may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of AEE788 when~     given together with everolimus and to see how well they work in treating patients with~     recurrent or relapsed glioblastoma multiforme.~   "
262952|NCT00107211|"~     RATIONALE: Vaccines made from peptides and a person's white blood cells may help the body~     build an effective immune response to kill tumor cells. Injecting the vaccine directly into a~     lymph node may cause a stronger immune response and kill more tumor cells. Giving vaccine~     therapy before surgery may be effective treatment for ductal carcinoma in situ of the breast.~      PURPOSE: This phase I trial is studying the side effects and best way to give vaccine therapy~     in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast.~   "
262953|NCT00107198|"~     This clinical trial is studying how well surgery and/or combination chemotherapy with or~     without radiation therapy or observation only work in treating young patients with newly~     diagnosed stage I or stage II lymphocyte predominant Hodgkin disease (LPHD). Surgery may be~     an effective treatment for LPHD. Drugs used in chemotherapy, such as doxorubicin,~     vincristine, prednisone, and cyclophosphamide, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Radiation~     therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination~     chemotherapy) with or without radiation therapy may kill more cancer cells.~   "
262954|NCT00107185|"~     RATIONALE: Vaccines made from a person's white blood cells and tumor cells may help the body~     build an effective immune response to kill tumor cells. Giving vaccine therapy after surgery~     may be a more effective treatment for malignant glioma.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating young patients who are undergoing surgery for malignant glioma.~   "
262955|NCT00107172|"~     This randomized phase III trial studies surgery and internal radiation therapy to see how~     well they work compared to surgery alone in treating patients with stage I non-small cell~     lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Internal~     radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.~     It is not yet known whether surgery and internal radiation therapy are more effective than~     surgery alone in treating non-small cell lung cancer.~   "
262956|NCT00107159|"~     RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help~     the body build an effective immune response to kill tumor cells.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients~     with unresected stage III or stage IV melanoma.~   "
262957|NCT00107120|"~     Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the~     S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake~     inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to~     provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment~     of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be~     eligible to enter an open-label extension study.~   "
262958|NCT00107107|"~     This is a multicenter, open-label extension study designed to examine the long-term safety of~     pramlintide treatment in subjects with type 1 diabetes who have successfully completed~     treatment in the parent study 137-150.~   "
262959|NCT00107094|"~     In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide~     followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage~     breast cancer.~   "
263280|NCT00102674|"~     The purposes of this study are to:~        -  Evaluate the tolerability of two cangrelor regimens.~        -  Compare the PD of cangrelor regimens with oral clopidogrel.~   "
262960|NCT00107081|"~     The purpose of this study is to determine whether, in children with cancer presenting with~     fever in severe chemotherapy-induced neutropenia at low risk for medical complications, oral~     antibiotics in an outpatient setting after an initial phase of intravenous antibiotics and~     in-hospital observation for 8 to 22 hours, is not inferior as to safety and efficacy compared~     to continued intravenous antibiotics given in-hospital.~   "
262961|NCT00107068|"~     This study will investigate the efficacy of aerobic exercise and progressive resistance~     training (PRT), singularly and combined, on changes in walking endurance for~     mildly-to-moderately affected chronic stroke patients. Specifically, we will determine the~     relative importance of training induced changes in muscle strength versus aerobic fitness on~     increases in gait velocity and 6-min walking distance, and assess the concomitant functional~     and psychosocial impact of increased muscle strength, aerobic fitness and improved gait. This~     longitudinal study will be conducted as a double blinded factorial randomized controlled~     trial of exercise training for chronic stroke patients.~   "
262962|NCT00107055|"~     The purpose of this study is to gain initial safety and efficacy data on the experimental~     agent REN-1654 in patients with pain that radiates down the leg(s), and is typical of~     sciatica (lumbosacral radiculopathy). These patients will usually have a herniated disc that~     is causing compression on the nerves coming out of the spinal column.~   "
262963|NCT00107042|"~     This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a~     two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate~     immunogenicity of the products in this population, barriers to vaccine delivery, and factors~     which predict a diminished immune response. Since these youths are also potential candidates~     for future HIV vaccine trials, this study will also include preliminary assessment of youths'~     understanding of informed consent forms, and willingness to participate in a vaccine trial~     and return for multiple visits (including blood draws for immunologic assessment).~   "
262964|NCT00107029|"~     This protocol is a study of HIV+ young people who were identified as having certain HIV-1~     specific T-cell responses and genetic markers while previously enrolled in the 5-year~     longitudinal adolescent study, REACH. Blood samples will be collected, a medical and~     medication history and physical examination will be performed every 6 months for a total of 2~     years.~   "
262965|NCT00107016|"~     The purpose of this study is to examine the effect of the combination of everolimus and~     letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly~     diagnosed estrogen receptor positive breast cancer.~   "
262966|NCT00107003|"~     This study will examine whether an experimental drug called GW572016 can delay tumor growth~     in patients with glioblastoma multiforme (GMB, a malignant brain tumor). GW572016 is believed~     to affect cancer cell function by interfering with the internal signaling needed for the~     cancer to grow. The study will also determine whether the presence of specific proteins in~     the tumor can predict what effects GW572016 will have on the tumor.~      Patients 18 years of age and older with GMB whose brain tumor does not respond to standard~     medical treatment and who can undergo surgery for their tumor may be eligible for this study.~     Candidates are screened with a physical examination and neurocognitive examination, blood~     tests, electrocardiogram (EKG), echocardiogram (ultrasound test of heart function) or MUGA~     scan (nuclear medicine test of heart function), magnetic resonance imaging (MRI) of the head,~     and computed tomography (CT) of the head. CT uses x-rays and MRI uses a magnetic field and~     radio waves to show brain structure.~      Participants undergo the following tests and procedures:~        -  MRI and blood tests before surgery.~        -  Surgery to remove the brain tumor.~        -  Follow-up MRIs every 8 weeks after surgery.~        -  Follow-up echocardiograms or MUGA scans every 8 weeks after surgery.~        -  GW572016 treatment starting 7-10 days before surgery and continuing until the patient or~          doctor decides it is in the patient's best interest to stop it or until the tumor~          worsens. (The drug is stopped temporarily for surgery and a healing period after~          surgery.)~        -  Blood tests every 2 weeks to evaluate the effects of GW572016 on the body.~        -  Blood test before the first GW572016 treatment and at the time of surgery to assess the~          effect of the drug on the cells and to determine how much drug is present in the blood~          at the time of surgery.~      Participants are followed in clinic at least monthly while taking GW572016. While on~     treatment they keep a diary documenting their daily treatments. The diary is collected at the~     monthly follow-up exams. After the treatment ends, patients are contacted periodically by the~     research staff for the rest of their lives to follow the long-term effects of the study.~   "
262967|NCT00106977|"~     This study will explore the range and type of medical and developmental problems in patients~     with Muenke syndrome, a condition that results when one or more of the suture between the~     bones of the skull close before birth. Because of the premature closure, the skull is not~     able to grow in its natural shape; instead, it compensates with growth in areas of the skull~     where the sutures have not yet closed. This can result in an abnormally shaped head, wide-set~     eyes, and flattened cheekbones. Patients may also have an enlarged head, abnormalities of the~     hands or feet, and hearing loss.~      The fibroblast growth factor receptor 3 (FGFR3) gene, which is involved in the development~     and maintenance of bone tissue, plays a role in Muenke syndrome. In some cases, the FGFR3~     mutation is inherited from a parent with Muenke syndrome; in other cases, where there is no~     family history of the disorder, the mutation occurs anew. A better understanding of this gene~     may lead researchers to develop better treatments and genetic counseling for people affected~     by Muenke syndrome.~      Patients with Muenke syndrome and their blood relatives may be eligible for this study.~     Family members with confirmed Muenke syndrome will have genetic counseling, and patients~     undergo the following tests and procedures:~        -  Review of medical records and test results.~        -  Questionnaires about the patient's prenatal, birth, newborn, and past medical history;~          family history; growth and development; medications; and current therapies.~        -  Physical, neurological, ear, nose and throat, dental, and eye examinations.~        -  Neuropsychological testing to assess cognitive thinking abilities.~        -  Hearing evaluation. This includes an audiology test in which the patients listens to~          soft tones through earphones; a power reflectance test in which a chirping sound is~          heard through an earpiece placed at the entrance to the ear canal, and possibly an~          ABR/ASSR test, in which electrodes are attached to the forehead, earlobes, and behind~          the ears to measure brain waves in response to certain conditions.~        -  MRI scan of the brain. MRI uses a strong magnetic field and radio waves to produce~          detailed pictures of the brain. During the scan, the patient lies on a table in a narrow~          cylinder (the scanner), wearing ear plugs to muffle loud noises that occur with~          electrical switching of the magnetic fields.~        -  MRI scan of the middle and inner ear. This test is similar to the MRI, but uses a dye~          injected in a vein to enhance the images.~        -  CT scan of the skull. CT uses x-rays to produce 3-dimensional images of the part of the~          body studied.~        -  Dental evaluation with x-rays.~        -  Skeletal survey (x-rays of all bones of the body).~        -  Developmental assessment of IQ testing.~        -  Blood tests for research purposes. A cell line may be established for use in future~          research.~        -  Medical photographs to demonstrate clinical features, including side and front views of~          the face, head, and other parts of the body that may be involved in Muenke syndrome,~          like the hands and feet.~        -  Other consultations or tests as clinically indicated~   "
262968|NCT00106964|"~     Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by~     vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate~     protection against this virus. In an attempt to improve response to vaccination and achieve~     protection from hepatitis B, this trial will compare the immune system response to 3~     hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.~   "
262969|NCT00106951|"~     To investigate the role of racial and socioeconomic disparities in coronary heart disease~     (CHD) mortality in the United States.~   "
262970|NCT00106938|"~     The study is being conducted to demonstrate the non-inferiority of carotid artery stenting~     (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to~     carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid~     atherosclerotic disease.~   "
262971|NCT00106925|"~     This study will provide follow-up evaluation and care of patients who have undergone~     allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are~     monitored for their response to treatment, disease relapse, and later-occurring effects of~     the transplant.~      Patients between 10 and 80 years of age who received a donor stem cell transplant at the NIH~     Clinical Center under an NHLBI protocol may be eligible for this study. Candidates must have~     had their first transplant at least 3 years before entering the current study.~      Participants are generally seen in the clinic every 12 months for some or all of the~     following procedures:~        -  Periodic physical examinations, eye examinations, and blood and urine tests.~        -  Bone marrow aspiration and biopsy: A sample of bone marrow is obtained for microscopic~          examination. The patient is given local anesthesia or conscious sedation. An area of the~          hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small~          amount of marrow is withdrawn.~        -  Tissue biopsy: A small piece of tissue or tumor is obtained for microscopic examination.~          Depending on the site of the biopsy, the tissue may be removed using a cookie~          cutter-like punch instrument, a needle, or a knife. The area is numbed and the tissue~          is removed with the appropriate tool.~        -  Imaging tests to visualize organs, tissues, and cellular activity in specific tissues.~          For these tests, the patient lies on a table that slides into the scanner. They may~          include the following:~             1. Nuclear scans use a sensitive camera to track a small amount of radioactive~               material (radioisotope) that is given to the patient by mouth or through a vein.~               The scan may show abnormal areas of tissue in the bones, liver, spleen, kidney,~               brain, thyroid, or spine.~             2. Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to examine~               small sections of body organs and tissues.~             3. Computerized tomography (CT) uses x-rays and can be done from different angles to~               provide a 3-dimensional view of tissues and organs.~             4. Positron emission tomography (PET) uses a fluid with a radioisotope attached to it~               to show cellular activity in specific tissues. The fluid is given through a vein~               and travels to the cells that are most active (like cancer cells), showing if there~               is an actively growing tumor.~        -  Pulmonary (lung) function tests: The patient breathes into a machine that measures the~          volume of air the person can move into and out of the lungs.~        -  Heart function tests may include the following:~             1. Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes~               placed on the chest transmit information from the heart to a machine.~             2. Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an~               image of the heart and examine the function of the heart chambers and valves.~             3. Multiple gated acquisition scan (MUGA) is a nuclear medicine test that uses a small~               amount of radioactive chemical injected into a vein. A special scanner creates an~               image of the heart for examining the beating motion of the muscle.~      Disease relapse or progression, or transplant-related problems may be treated with standard~     medical, radiation, or surgical therapy, or patients may be offered experimental therapy.~   "
262972|NCT00106912|"~     This study will collect data needed to design a treatment trial for patients with Fabry~     disease using the experimental drug AT-1001. Fabry disease is an inherited metabolic disorder~     in which an enzyme called alpha-galactosidase A, which normally breaks down fatty substances~     called glycolipids, is missing or does not function properly. As a result, glycolipids~     accumulate in various tissues, causing liver, kidney, nerves, skin, muscle and blood vessel~     problems. No treatment is given in this survey study.~      Males 18 years of age and older with Fabry disease who have certain genetic mutations~     associated with enhancement of alpha-galactosidase A activity may be eligible for this study.~     Participants undergo the following tests and procedures over 5 days:~      Day 1~      Medical history and physical examination, blood tests, electrocardiogram (EKG), routine~     urinalysis, measurements of height, weight, and vital signs (blood pressure, heart rate,~     breathing rate, and temperature).~      Day 2~      Blood tests, 24-hour urine collection, vital signs and sweat test. The sweat test (also~     called QSART, or quantitative sudomotor axon reflex test) measures the amount of sweat in a~     particular area of skin. A small amount of medication called acetylcholine is put on an area~     of the skin and a small electric current is applied to stimulate the sweat glands.~      Day 3~      Blood tests, 24-hour urine collection, vital signs, and skin biopsy. For the skin biopsy, a~     small area of skin is numbed and a punch device is used to remove a 3-mm (1/8-inch) layer of~     skin for microscopic examination.~      Day 4~      Blood tests, 24-hour urine collection, vital signs, and QSART.~      Day 5~      Blood tests and vital signs.~      In addition to the above, patients are scheduled at some point in the 5-day study for an eye~     examination, brain magnetic resonance angiogram (MRA), and a heart examination and~     echocardiogram. MRA uses a strong magnetic field and radio waves to provide images of the~     blood vessels in the head and neck. It can detect abnormalities such as aneurysms, vessel~     malformations, and thickening of the vessel walls. An echocardiogram is an ultrasound test~     that shows how well the heart pumps blood and if there is thickening of the heart muscle.~      Patients who are taking enzyme replacement therapy discontinue treatment for up to 6 weeks~     (no more than two missed infusions) to allow accurate measurement of the amount of~     alpha-galactosidase A the patient's body produces by itself. They provide weekly blood~     samples between the time they stop treatment and enter the study. The samples are used to~     monitor the removal of the enzyme from the body and the possible buildup of Gb(3) in the~     blood.~   "
263305|NCT00102349|"~     The purpose of this study is to test two strategies to reduce the risk of contracting Human~     Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) by reducing risk behaviors in~     patients undergoing drug detoxification.~   "
262974|NCT00106886|"~     The purpose of the HOPE-2 study is to determine whether long term supplementation with folic~     acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal~     and nonfatal cardiovascular events in patients with established cardiovascular disease and/or~     diabetes mellitus.~   "
262975|NCT00106860|"~     The purpose of the study is to assess the safety and effectiveness of the experimental drug,~     a benzodiazepine drug, in long-term use and the effects on quality of life, social and~     occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.~   "
262976|NCT00106847|"~     The purpose of the study is to evaluate the safety and effectiveness of scheduled and as~     needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific~     proteins in the body's immune system to help control the development of inflammation to help~     reduce painful disease.~   "
262977|NCT00106834|"~     The purpose of this study is to determine if infliximab (anti-TNF) is effective in the~     treatment of plaque psoriasis.~   "
262978|NCT00106821|"~     The purpose of this study is to look at the benefits of tiotropium, an approved drug for the~     treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), in a~     population of patients with COPD who are of African American descent.~   "
262979|NCT00106808|"~     The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2~     Diabetes. Both the safety and blood sugar lowering effects of these treatments will be~     studied.~   "
262980|NCT00106795|"~     This study will examine abnormalities in mitochondria (energy-producing machinery of cells)~     and in genes related to mitochondria in the blood cells, muscle, and fat of HIV-positive~     patients who are taking nucleoside reverse transcriptase inhibitors (NRTIs) and in patients~     not currently taking HIV medications, and compare the results to healthy volunteers. Many~     patients with HIV infection take NRTIs to help control the infection. These medications may~     damage cell mitochondria, possibly causing side effects such as fatigue. This study will~     explore the relationship between changes in mitochondria and related genes and patient~     reports of energy level, mood and quality of life.~      Healthy volunteers and HIV-infected patients between 18 and 55 years of age may be eligible~     for this study. Healthy volunteers must test negative for the HIV antibody. HIV-positive~     patients must have been diagnosed positive for at least 1 year. Patients who are taking~     antiretroviral therapy must have been taking the same drug regimen (with at least two NTRIs~     and no protease inhibitors) for at least 3 months. HIV positive patients not taking~     antiretroviral medication must not have had antiretroviral therapy for at least 1 year.~     Candidates are screened with a medical history, brief physical examination, blood and urine~     tests, and questionnaires related to mood and energy.~      Qualified volunteers will undergo the following procedures during three or four study visits:~      Visit 1~      Complete history and physical examination, blood tests, and questionnaires about energy~     level, mood, and quality of life.~      Visit 2~      Muscle and fat biopsy: Before the biopsy, blood is drawn to check blood counts and to test~     for pregnancy in women who can become pregnant. The biopsy is done on an outpatient basis in~     the operating room. The site of the biopsy (an area on the upper arm or upper leg) is numbed~     with an injection under the skin. A 1-inch incision is made over the muscle to be biopsied~     and a small sample of muscle tissue and small sample of fat are removed. The incision is then~     closed and bandaged. Following the biopsy, you will be monitored for about 4 hours in the~     clinic. Strenuous physical activity should be restricted in the week following biopsy to~     allow healing.~      Visit 3~      Examination of biopsy site and possible apheresis: The biopsy site is examined for healing.~     Apheresis may be scheduled for this visit or for an extra visit between the biopsy and the~     final visit. This procedure for obtaining white blood cells for study is optional. For~     apheresis, blood is withdrawn from a needle placed in a vein in the arm and the white cells~     are separated from the rest of the blood. The white cells are extracted and the red cells and~     plasma are then returned to the body through a second needle.~   "
262981|NCT00106782|"~     This study will evaluate the effect of transcranial electrical polarization (TEP), also~     called direct current (DC) stimulation, on focal hand dystonia in people with writer's cramp.~     In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or abnormal~     postures. Focal dystonia involves just one part of the body, such as the hand, neck or face.~     When people with focal hand dystonia make small and repeated movements with their hands,~     there is extra activity in the part of the brain called the motor cortex. TEP is a method of~     brain stimulation that slows down the activity of the nerve cells in the motor cortex. This~     study may help researchers develop new ways to treat focal hand dystonia.~      People 18 years of age and older with focal hand dystonia may be eligible for this study.~     Participants have a neurological examination and are randomly assigned to one of two~     treatment groups: TEP or placebo stimulation. The TEP group receives stimulation to the parts~     of the brain used for hand movement, and the placebo group receives sham stimulation, which~     does not affect any area of the brain. There are three TEP/placebo sessions over a period of~     7 to 10 days. The first session may last up to 2-1/2 hours; the other two sessions last 1-2~     hours.~      For TEP, sponge electrodes are placed on the scalp and an electrical current is passed~     through the scalp and skull to the outer part of brain. Before and after each session,~     participants have a neurological examination, including an evaluation of the rate and~     severity of their movement problems. For this assessment, participants do a writing test~     while the electrical activity of their hand muscles is recorded using surface~     electromyography (EMG). For EMG, small metal disks (electrodes) filled with a conductive gel~     are taped to the skin over the muscles being tested.~      Patients are followed in the clinic the day after the end of TEP treatment for evaluation of~     their movement abilities and the effects of therapy, such as improvement of handwriting.~   "
262982|NCT00106769|"~     This study will test the safety of an experimental vaccine intended to prevent West Nile~     virus (WNV) infection and determine if it causes side effects. WNV symptoms may vary from~     fever and headache, to a polio-like syndrome with paralysis. Infection rarely results in~     death. The vaccine used in this study contains DNA that instructs the body to produce a small~     amount of a protein found in WNV. If the body creates resistance or immunity to these~     proteins, then the vaccine may protect against WNV. Study participants cannot get WNV from~     the vaccine.~      Healthy volunteers between 18 years and 50 years of age may be eligible for this study.~     Candidates are screened with a medical history, physical examination, and blood and urine~     tests, including a pregnancy test for women who can become pregnant. Patients undergo the~     following tests and procedures:~        -  Vaccine injections: Vaccines are given as injections in the upper arm, using a~          needleless system called the Biojector 2000. The first injection is on study day 0, the~          second on day 28 (+/-) 7 days, and the third on day 56 (+/-) 7 days. There must be at~          least 21 days between injections. The pregnancy test for women of childbearing potential~          is repeated the day of each vaccine injection.~        -  Diary card: Participants are given a 5-day diary card after each injection to record~          their temperature and any symptoms and side effects they may experience for up to 5 days~          after the injection. The diary cards are returned to the clinic at visits scheduled 2~          weeks after each injection. Side effects and symptoms also must be reported immediately~          to a study nurse or doctor, and a clinic visit may be required for an examination.~        -  Clinic visits: At day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32, participants have a~          medical history, physical examination (if needed) and blood tests. Vital signs and~          weight are also recorded. Lymph nodes are examined at day 0 and weeks 2, 4, 6, 8, 10 and~          12, and urine samples are collected at day 0 and weeks 2, 4, 6, 8 and 10.~      Some of the blood drawn during this study is used for genetic tests to see if different types~     of immune response to a vaccine are related to genetic differences in people.~   "
262996|NCT00106574|"~     This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and~     symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying~     Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid~     arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be~     randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with~     stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target~     sample size is 500+ individuals.~   "
262997|NCT00106561|"~     The purpose of this study is to determine which combination of the tablets ramipril,~     irbesartan or spironolactone is best to lower protein leakage from the kidney.~   "
263016|NCT00106301|"~     The purpose of this study is to evaluate the safety and tolerability of extended treatment~     with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate~     cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228~     clinical trials.~   "
272905|NCT00021879|"~     To investigate the influence of total body fat and visceral fat on risk factors of diabetes~     and cardiovascular disease (CVD) in black and white women.~   "
262983|NCT00106756|"~     This study will examine the extent of the vision problem in familial exudative~     vitreoretinopathy (FEVR) and try to identify the genes responsible for this hereditary eye~     disorder. Patients with FEVR have incomplete formation of blood vessels in the periphery of~     the retina (the inner part of the eye that is responsible for vision). As a result, abnormal~     vessels can form and retinal detachment and vitreous bleeding can occur, causing significant~     vision loss. Vision loss usually begins in childhood, gradually worsening over time. Some~     patients eventually become blind.~      Patients of all ages with FEVR and their family members may be eligible for this study.~     Participants undergo the following tests and procedures:~        -  Family history, especially regarding eye disease. A family tree is drawn.~        -  Blood draw for genetic testing related to FEVR.~        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to~          examine pupils, lens, retina and eye movements. The pupils are dilated with drops for~          this examination.~        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected~          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina~          are taken using a camera that flashes a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating possible blood vessel~          abnormality.~        -  Patients affected with FEVR will also undergo DEXA scan to look for osteoporosis. X-rays~          are used to scan the hip, forearm and spine for bone density measurements.~   "
262984|NCT00106743|"~     This study will explore clinical and genetic aspects of Usher syndrome, an inherited disease~     causing deafness or impaired hearing, visual problems, and, in some cases, unsteadiness or~     balance problems. Patients with type 1 Usher syndrome usually are deaf from birth and have~     speech and balance problems. Patients with type 2 disease generally are hearing impaired but~     have no balance problems. Patients with type 3 disease have progressive hearing loss and~     balance problems. All patients develop retinitis pigmentosa, an eye disease that causes poor~     night vision and eventually, blindness.~      Patients of any age with Usher syndrome may be eligible for this study. Patients who have had~     eye and hearing evaluations are asked to send their medical records to the research team at~     the National Eye Institute (NEI) for review. They are also asked to have a blood sample drawn~     by a medical professional and sent to NEI for genetic analysis. Finally, they are interviewed~     about their family histories, particularly about other relative with eye disease. Patients~     who have not been evaluated previously have the following tests and procedures at NIH:~        -  Family medical history, especially regarding eye disease. A family tree is drawn.~        -  Blood draw for genetic studies of Usher syndrome.~        -  Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens,~          retina, and eye movements.~        -  Electroretinogram (ERG) to test the function of visual cells. Wearing eye patches, the~          patient sits in a dark room for 30 minutes. Electrodes are taped to the forehead and the~          eye patches are removed. The surface of the eye is numbed with eye drops and contact~          lenses are placed on the eyes. The patient looks inside a hollow, dark globe and sees a~          series of light flashes. Then a light is turned on inside the globe and more flashes~          appear. The contact lenses sense small electrical signals generated by the retina when~          the light flashes.~        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected~          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina~          are taken using a camera that flashes a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating possible blood vessel~          abnormality.~        -  Hearing tests to help determine the patient's type of Usher syndrome. Tests to evaluate~          hearing include examination of both ears with an otoscope, evaluation of the middle ear~          and inner ear, and hearing tests using earphones that deliver tones and words the~          subject listens and responds to.~        -  Vestibular testing for balance function. Balance testing involves three procedures:~      Videonystagmography: This test records eye movements with little cameras. First the patient~     follows the movements of some small lights. Next, while wearing goggles, the patient lies on~     an exam table and turns to the right and left. Lastly, a soft stream of air is blown into the~     patient's ears four times, once in each ear with cool air and once in each ear with warm air.~      Rotary chair test: With electrodes placed on the forehead, the patient sits in a rotary chair~     in a dark room. Several red lights appear on the wall of the room and the patient follows the~     lights as they move back and forth. Then the chair turns at several speeds, all slower than a~     merry-go-round.~      Vestibular evoked potential: Electrodes are placed behind the patient's ear and at the base~     of the neck. Seated in a reclining chair and wearing earphones, the patient hears a brief~     series of loud clicking sounds. When the sounds are on, the patient is asked to lift his or~     her head up a few inches from the chair. The electrodes record information from the muscles~     in the neck as the sounds enter the ear.~   "
262985|NCT00106717|"~     Narrative medicine addresses the therapeutic benefits that derive from patients forming and~     telling their personal stories. It offers an innovative model for improving health outcomes.~     When a patient with cancer and marked suffering writes a narrative of what he or she is going~     through, this process may reduce pain and improve quality of life.~      Therefore, we seek to evaluate the effectiveness of writing a narrative on pain intensity and~     health related quality of life.~      We propose a randomized single blind (evaluator) controlled trial. Patients with cancer pain~     of intensity at least 5/10 with a minimum Karnofsky score of 50% will be randomized into~     three groups: 1. Narrative group. Patients will write a story about their illness for at~     least 20 minutes once a week for 3 weeks; 2. Writing-control group. Patients will fill a pain~     diary once a week for three weeks; 3. Control group. Subjects will not write/fill anything.~     Pain will be evaluated using the numerical scale before randomization and then weekly for 8~     weeks. We will also evaluate how pain interferes with general activity, mood, work, relation~     with others, sleep, and enjoyment of life using the Brief Pain Inventory. As secondary~     outcomes, we will evaluate health related quality of life, with the treatment outcomes of~     pain survey, which is a modification of the SF 36 (short form health survey), and a global~     measure of well-being before randomization, and then at 4 and 8 weeks. We will also evaluate~     the emotional disclosure of the narratives.~      We will use an intention to treat analysis. To analyze the effect of the treatment on pain~     intensity, quality of life, and well-being, we will employ an analysis of repeated measures~     using generalized estimating equations. We will include in the regression models the~     treatment group, the emotional disclosure score, the time, and the interaction between~     treatment group and time.~   "
262986|NCT00106704|"~     The purpose of this clinical study is to determine the safety and efficacy of an~     investigational drug in patients with Type 2 diabetes mellitus.~   "
262987|NCT00106691|"~     The purpose of this study is to determine if toremifene citrate is effective and safe in the~     prevention of prostate cancer in men who have been diagnosed with high grade prostatic~     intraepithelial neoplasia (PIN).~   "
262988|NCT00106678|"~     A number of factors influence HIV-positive adolescents' acceptance of and willingness to~     continue taking anti-HIV medicines. These factors include mental health and substance abuse~     issues, barriers such as lack of medical insurance, and cognitive-behavioral barriers (such~     as a person's impression of the impact of the medicines on his/her health and a person's~     sense of his/her ability to continue taking the medications prescribed). The purpose of this~     study is to use a survey to determine how common specific barriers are that prevent HIV~     positive adolescents from taking their anti-HIV medicines and if those barriers cluster~     together. The information collected will be used to develop and validate a schema for~     classifying HIV medication adherence by barriers to adherence or clusters of barriers to~     adherence. This classification schema could then be used in the development of interventions~     that better meet the needs of HIV-infected youth.~   "
262989|NCT00106665|"~     This study seeks to define the morbidity of critical care polyneuropathy and to confirm that~     this diagnosis is, in fact, independently associated with increased mortality. Secondary~     information regarding the reasons for ICU readmission in patients with weakness may help in~     formulating cogent discharge strategies for these patients. Measurement of weakness using~     handgrip strength may provide a useful surrogate marker for weakness that may be more easily~     and uniformly applied.~      Primary hypothesis:~        -  The development of ICU-associated weakness is independently associated with excess~          attributable mortality.~      Secondary hypothesis:~        -  The development of ICU-associated weakness is associated with an increased need for ICU~          readmission.~        -  Readmission to the ICU will be a result of the development of recurrent respiratory~          failure or insufficiency~        -  Handgrip strength testing will detect ICU-associated weakness with an equivalent~          sensitivity as the comprehensive bedside muscle strength exam.~   "
262990|NCT00106652|"~     The purpose of this study is to understand how genes, environment, and the interplay between~     the two, influences the development of autism and other neurodevelopmental disorders.~   "
262991|NCT00106639|"~     This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of~     CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with~     basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant~     patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had~     completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the~     same treatment groups.~   "
262992|NCT00106626|"~     The purpose of this investigational study is to determine the safety and tolerability of oral~     suberoylanilide hydroxamic acid when administered in combination with standard doses of~     pemetrexed and cisplatin for the treatment of advanced solid tumors.~   "
262993|NCT00106613|"~     The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell~     carcinoma (RCC) patients who have developed progressive disease (PD) following or during~     treatment with immunotherapy.~   "
262994|NCT00106600|"~     The goal of this study is to find the safest dose of Pixantrone (BBR 2778) that can be given~     to patients with Acute Myelogenous Leukemia (AML). After the safest dose is found, up to an~     additional 86 patients will be enrolled. During this part of the study, the safety and~     effectiveness will be evaluated.~   "
262995|NCT00106587|"~     The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the~     efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent~     restenosis.~   "
262998|NCT00106548|"~     This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and~     symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in~     patients with moderate to severe active rheumatoid arthritis (RA) who currently have an~     inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv,~     tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive~     methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the~     target sample size is 500+ individuals.~   "
262999|NCT00106535|"~     This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs~     and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in~     combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid~     arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg~     IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week.~     The anticipated time on study treatment is 1-2 years and the target sample size is 500+~     individuals. After completion of the 2 year study participants could participate in the~     optional 3 year open label extension phase (year 3 to 5).~   "
263000|NCT00106522|"~     This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and~     symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients~     with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who~     have had an inadequate response to prior therapy with an anti-tumor necrosis factor~     (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab~     8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate~     10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample~     size is 500+ individuals.~   "
263001|NCT00106509|"~     Approximately 520 patients will be entered into this study taking place throughout the US and~     Canada. This study aims to determine if an investigational drug is safe and effective for~     treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat~     episodes of CDAD. The investigational drug will be evaluated in comparison to current~     standard antibiotic treatment, so all patients will receive active medication. All study~     related care is provided including doctor visits, physical exams, laboratory tests and study~     medication. Total length of participation is approximately 6 weeks.~   "
263002|NCT00106496|"~     The purpose of the study is to determine the impact of topical corticosteroids on the safety~     and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe~     Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo~     in the long-term management of Atopic Dermatitis~   "
263003|NCT00106483|"~     To test the primary hypothesis that individuals with pre-clinical connective tissue disease~     related autoimmunity are more likely to demonstrate subsequent development of sub-clinical~     coronary artery disease.~   "
263004|NCT00106470|"~     The purpose of this study is to examine genetic factors that influence the development of~     chronic obstructive pulmonary disease (COPD) in Hispanics, a minority group at high risk for~     the disease.~   "
263005|NCT00106457|"~     To understand the complex, longitudinal relations between physical fitness, physical~     activity, body mass and composition and fat distribution, and genetic factors and their~     independent or interactive effects on the development of obesity, the metabolic syndrome, and~     sub-clinical cardiovascular disease.~   "
263006|NCT00106431|"~     GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted~     at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the~     efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma~     (CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m^2 intravenously over 4~     hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles~     although pts who showed an objective response or stable disease could continue to receive~     therapy, at the discretion of the investigator, until disease progression or another~     withdrawal criterion was met.~   "
263007|NCT00106418|"~     The purpose of this study is to evaluate the activity of romidepsin (depsipeptide,FK228) in~     patients with metastatic prostate cancer who have developed a rising prostate specific~     antigen (PSA) while undergoing hormonal therapy.~   "
263008|NCT00106405|"~     Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has~     considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric~     emergencies and is associated with significant morbidity and mortality. The purpose of the~     study is to evaluate the safety and efficacy of open-label memantine in the acute management~     of adults with bipolar I disorder hospitalized for mania.~   "
263009|NCT00106392|"~     The purpose of the study is to compare the safety and effectiveness of Prograf in the~     prevention of erectile dysfunction in men after a radical prostatectomy.~   "
263010|NCT00106379|"~     The purpose of this study is to provide long-term clinical safety and efficacy data for~     tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various~     degrees of renal impairment.~   "
263011|NCT00106366|"~     This trial is conducted in the United States of America (USA). The purpose of this study is~     to determine if the use of insulin detemir in combination with insulin aspart is safe and at~     least as effective as insulin glargine in combination with insulin aspart for the control of~     blood glucose in patients with Type 2 diabetes.~   "
263012|NCT00106353|"~     This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV)~     infusion once weekly to pediatric subjects with advanced solid tumors.~      Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly~     to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or~     refractory to standard therapy or for whom standard therapy is not available. (enrollment~     completed) Part 2 will be conducted in three groups of children with refractory or relapsed~     pediatric solid tumors. Subjects with the following tumor types will be enrolled:~     neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV~     temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)~   "
263013|NCT00106340|"~     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a~     single oral drug. The purpose of this study is to assess the long term safety and~     effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in~     lowering overall blood glucose levels when added to metformin in people with type 2 diabetes~     not at target blood glucose levels on metformin alone.~   "
263017|NCT00106288|"~     The purpose of this study is to determine the efficacy and safety of micafungin (FK463)~     versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic~     patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and~     pediatric patients.~   "
263018|NCT00106275|"~     Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and sleep disorders being the~     main symptoms. There is no commonly accepted efficacious treatment modality. Training in~     mindfulness-based stress reduction (MBSR) is a structured, 8-week, cognitively and~     affectively oriented intervention program, and has been shown to produce health benefits in a~     number of studies.~      We plan to conduct a randomized, controlled, clinical study with the aim of testing the~     efficacy of MBSR for fibromyalgia. Because fibromyalgia is almost exclusively a female~     disorder, we will limit this investigation to women. 180 female, fibromyalgia patients will~     be randomized into three groups:~        1. Mindfulness training~        2. Active control~        3. Wait-list control.~      The main outcome criteria are self-reported and fibromyalgia-specific Quality of Life (QOL),~     and a Biobehavioral Fibromyalgia Index composed of a variety of psychophysiological and~     behavioral variables. This index will be generated from data gathered via an ambulatory~     psychophysiological monitoring system, which comprises parameters of mobility, sleep quality,~     and cardiovascular well-being. These and other relevant variables (depression score, general~     QOL, pain quality, anxiety, mindfulness, compliance, other therapeutic measures) will be~     assessed at the beginning and end of the training, as well as at 4- and 12-months~     post-treatment. A primary focus will be assessing whether it is possible to promote~     psychological well-being through the learning of attentive presence and any resultant~     affective affirmation.~   "
263019|NCT00106262|"~     This study is conducting an evaluation of two chemotherapy drugs, Velcade and Irinotecan, in~     women with advanced, recurrent, or metastatic cervical cancer, vaginal cancer, or vulvar~     cancer. Patients with cervical cancer may have received a platinum-containing treatment as~     systemic therapy without radiation, but is not required.~   "
263020|NCT00106249|"~     This study will evaluate the clinical efficacy of functional Magnetic Resonance Imaging~     (fMRI) guided 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied to the~     Supplementary Motor Area (SMA) in OCD patients who have not fully responded to conventional~     therapies. The investigators will collect TMS measures of motor cortex excitability to test~     whether rTMS restores normal levels of intracortical inhibition found to be deficient in OCD.~     The investigators hypothesize that:~        1. Compared to sham (placebo), active rTMS will improve symptoms of OCD as assessed with~          the Yale Brown Obsessive Compulsive Scale (Y-BOCS) and Clinical Global Impression (CGI).~        2. Active (but not sham) rTMS will normalize levels of motor cortex excitability, as~          reflected by increased intracortical inhibition, motor threshold, and cortical silent~          period, and by decreased intracortical facilitation, relative to pre-treatment baseline.~   "
263021|NCT00106236|"~     The purpose of the study is to determine whether exercise has further beneficial effects on~     improving cardiovascular risk factors such as hypertension, high cholesterol level or~     diabetes mellitus, when added to the standard program of health check followed by life style~     recommendations.~   "
263022|NCT00106223|"~     In an earlier phase of this study, a cognitive behavioral therapy (CBT) manual to treat body~     dysmorphic disorder (BDD) symptoms was developed. We are currently implementing this~     manual-based treatment to validate its effectiveness in patients with BDD.~   "
263023|NCT00106210|"~     This study will determine the impact of early intervention on the communication and social~     development of toddlers with autism.~   "
263024|NCT00106197|"~     This study will determine whether there are age-related differences in the body systems~     controlling sleep and stress hormone patterns. This study will also determine whether the~     differences in sleep and hormone patterns between depressed adolescents and adults are~     associated with differences in their response to antidepressant treatment.~   "
263025|NCT00106184|"~     Rituximab is a man-made antibody used to treat certain types of cancer. This study will~     determine whether rituximab is an effective treatment for adult and pediatric patients with~     dermatomyositis or polymyositis.~      Study hypotheses: 1) The time to improvement in Group A patients (receiving rituximab first)~     will occur significantly earlier than in Group B patients (receiving rituximab later). 2) The~     proportion of patients improved at Week 8 of the treatment phase will be significantly~     greater in Group A than in Group B.~   "
263026|NCT00106171|"~     It is not known if anti-HIV treatment for recently infected patients improves long-term~     patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV~     medications slows progression of HIV disease in adults recently infected with HIV.~      Study hypothesis: A one-year course of HAART administered during acute or early~     seroconversion may slow the progression of HIV infection.~   "
263027|NCT00106158|"~     The purpose of this study is to assess the safety of repeated doses of cholesterol-bearing~     hydrophobized pullulan (CHP) and NY-ESO-1 protein (CHP-NY-ESO-1) and describe the NY-ESO-1~     specific-humoral and cellular immune response to immunization with CHP-NY-ESO-1 in patients~     with cancer expressing NY-ESO-1.~   "
263028|NCT00106145|"~     An investigational study to determine the safety/tolerability, and efficacy of a notch~     signaling pathway inhibitor in patients with metastatic or locally advanced breast cancer and~     other advanced solid tumors.~   "
263029|NCT00106132|"~     This study will compare the safety and effectiveness of two treatments-injections of~     triamcinolone acetonide into the eye vs. standard laser therapy-for macular edema (swelling~     in the center of the retina) that is caused by blockage in a retinal blood vessel. Edema~     caused by blockage in a large vessel is called central retinal vein occlusion (CRVO). Edema~     caused by blockage in a smaller vein is called branch retinal vein occlusion (BRVO).~     Triamcinolone acetonide is a steroid drug that reduces swelling; the Food and Drug~     Administration has approved it for injection into joints and muscles to treat inflammatory~     conditions.~      Patients 18 years of age and older with macular edema due to CRVO or BRVO of between 3 and 18~     months' duration may be eligible for this study. Candidates are screened with a medical~     history, blood pressure measurement, and urine pregnancy test for women who can become~     pregnant. Screening also includes the following procedures:~        -  Eye examination to assess visual acuity and eye pressure, and to examine the cornea,~          lens, and retina. The pupils are dilated with drops for this examination.~        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected~          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina~          are taken using a camera that flashes a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating possible blood vessel~          abnormality.~        -  Optical coherence tomography to measure retinal thickness. The eye is examined with a~          machine that produces cross-sectional pictures of the retina. The patient is seated in~          front of a machine and looks at a pattern of flashing and rotating red and green lights,~          first with one eye and then with the other.~        -  Fundus photography to help evaluate the status of the retina and changes that may occur~          in the future. Photographs of the retina are taken using a camera that flashes a bright~          light into the eye.~      Participants are randomly assigned to receive triamcinolone injections or standard treatment.~     Triamcinolone is given in either a 1-mg or 4-mg dose. Standard treatment for CRVO and for~     BRVO with excessive blood in the retina is observation. Standard treatment for BRVO without~     excessive blood is laser therapy. Patients with BRVO who do not qualify for laser therapy~     when they enter the study may have it later if blood clears enough to permit treatment. The~     procedures for triamcinolone injections and laser therapy are as follows:~        -  Triamcinolone acetonide: The eye is numbed with anesthetic drops and the study drug is~          injected into the vitreous, the jelly-like substance located between the back of the~          lens and the retina. Patients apply antibiotic drops at home for 3 days following the~          procedure.~        -  Laser treatment: The eye is numbed with anesthetic drops and a special contact lens is~          placed on the eye during the laser beam application.~      All patients are followed every 4 months for 3 years. Additional visits may be scheduled if~     needed. Patients who receive triamcinolone injections are also examined within 1 week of each~     injection and 1 month after each injection. At the 4-month visits patients undergo repeat eye~     examination and fundus photography. Optical coherence tomography is done at some visits, and~     fluorescein angiography is repeated at months 4, 12 and 24. Blood pressure is measured at~     months 12, 24 and 36. Patients may be retreated with triamcinolone injections or laser~     therapy as often as every 4 months, depending on their response to treatment.~   "
263030|NCT00106119|"~     This study will examine how two thyroid preparations-levothyroxine (T4) and liothyronine~     (T3)-affect fat and cholesterol metabolism, blood sugar regulation, and thyrotropin secretion~     in patients who have had their thyroid gland removed. Results of the study may help in the~     development of better therapies to optimize blood sugar and cholesterol levels in some~     patients.~      Patients 18 years of age or older who have had most or all of their thyroid gland removed and~     are taking long-term thyroid hormone medication may be eligible for this study after~     screening.~   "
263031|NCT00106106|"~     This study will examine whether a new drug called acamprosate can be helpful for alcohol~     withdrawal, a result of drinking high amounts of alcohol for long periods of time. Alcohol~     withdrawal can cause various symptoms, including nausea or vomiting, anxiety or depression,~     tremor, high blood pressure, and others. During withdrawal, brain chemicals called~     neurotransmitters change, with some rising to abnormally high levels. These changes may~     contribute to alcohol craving, drinking relapse and impaired mental performance. This study~     will see if taking acamprosate for 4 weeks can lower the levels of neurotransmitters, such as~     glutamate, lessen withdrawal symptoms and decrease alcohol craving and brain damage~     associated with withdrawal.~      Healthy normal volunteers and alcohol-dependent patients between 21 and 65 years of age may~     be eligible for this study.~      Participants are admitted to the hospital for 28 days. They receive standard inpatient care~     for alcohol detoxification, including a medical history and physical examination,~     neurological evaluation, laboratory tests, nursing, nutrition, discharge planning and~     referrals for treatment of concomitant conditions, if needed. In addition, they are randomly~     assigned to take either two acamprosate or two placebo pills three times a day for 28 days~     and undergo the following tests and procedures:~        -  Days 1-28: Drug treatment. Patients take acamprosate or placebo daily. Patients with~          severe withdrawal symptoms may also receive diazepam (Valium). Throughout their~          hospitalization, patients fill out questionnaires about their emotional state and~          personality and are interviewed by staff about their mental health, use of alcohol,~          cigarettes, and illicit drugs, employment, support systems and family and social~          relationships, and their legal status.~        -  Days 2 and 3: Blood tests. Blood is tested for levels of the stress hormones cortisol~          and ACTH, which are released to excess during alcohol withdrawal. For this test, a~          heparin lock (thin, flexible plastic tube with a rubber stopper on the end) is placed in~          an arm vein for blood collections each day at 6 AM, 12 noon, 6 PM and 12 midnight.~          Patients rest in bed for 30 minutes before each collection.~        -  Day 4: Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). These~          procedures are done at the same time. They use a strong magnetic field and radio waves~          to show structural and chemical changes in the brain. The patient lies on a table in a~          space enclosed by a metal cylinder (the scanner) for about 20 to 30 minutes during the~          test.~        -  Day 5: Lumbar puncture (spinal tap). A local anesthetic is given to numb the area for~          the procedure. Then, a needle is inserted in the space between the bones in the lower~          back where the cerebrospinal fluid circulates below the spinal cord. A small amount of~          fluid is collected through the needle.~        -  Days 5 and 6: Dexamethasone-corticotropin releasing factor (CRF) test. This test~          measures the effect of alcohol withdrawal on ACTH and cortisol. The patient takes a~          standard dose of the steroid dexamethasone at 11 PM on day 5. At noon the next day, they~          are given lunch and then stay in bed and rest. A plastic tube is put in an arm vein. A~          salt water solution is slowly infused through the catheter and a blood sample is~          withdrawn through it. At 3 p.m., the patient is given 100 micrograms of the hormone CRF.~          Repeated blood samples are obtained to measure ACTH and cortisol.~        -  Days 23-27: All of the tests done on days 2-6 are repeated, except the MRI. MRS is~          repeated to measure neurotransmitters.~   "
263121|NCT00104884|"~     RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with~     unresectable stage III or stage IV malignant melanoma.~   "
272949|NCT00018616|"~     This is a randomized controlled trial of adherence. The study involves monitoring and~     managing focused intervention in patients prescribed metformin.~   "
263032|NCT00106093|"~     The purpose of this study is to gather information about people s drinking histories and to~     evaluate them for other research studies being conducted at the National Institute on Alcohol~     Abuse and Alcoholism (NIAAA). The evaluation will include a physical examination, blood~     tests, an MRI scan of the brain and completion of various questionnaires about alcohol use~     and mood. The information gathered from all of these tests will be used by researchers to~     gain a better understanding of the disease of alcoholism and determine eligibility for other~     NIAAA studies. This is an inpatient study so participants will stay at the NIH hospital for~     at least three weeks and up to six weeks if a person is found to be eligible for other NIAAA~     research studies.~      The study is open to people age 18 and older whose alcohol drinking has caused significant~     problems in their lives, and who desire alcoholism treatment. Detoxification will be provided~     if needed, and each person may participate in our alcoholism treatment program. The treatment~     includes group and individual counseling sessions as well as self-help meetings such as AA.~     Family counseling and recreational opportunities are also an important part of the treatment~     experience. The doctors, nurses, social workers and all of our other staff are committed to~     helping participants design an aftercare program that will help them leave the hospital and~     remain sober. Participants may also be able to attend a 12-week aftercare program in the~     NIAAA outpatient clinic.~   "
263033|NCT00106080|"~     The purpose of this study is to evaluate a multifaceted intervention to improve the quality~     of end-of-life communication between patients with COPD and their primary care providers~     using information about patients preferences for end of life care and how to communicate and~     use this information to activate patients, family members, and healthcare providers.~   "
263034|NCT00106067|"~     The diagnosis of advanced, incurable cancer at different stages of the adult life span holds~     a variety of meanings for family members who often must play critical roles in patient care~     and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of~     late-stage cancer in a loved one and may find it difficult to meet the demands of taking care~     of their loved one through end-of-life care and taking care of their own well-being. This~     grant provides funding to examine processes and outcomes of the intervention for family~     caregivers of advanced cancer patients.~   "
263035|NCT00106054|"~     The study was terminated early due to low enrollment with only 2 subjects enrolled and~     treated after being open for enrollment for over a year. Therefore, no meaningful efficacy~     analyses could be performed.~      This trial is studying the effects (good and bad) of a combination of drugs, Irinotecan in~     combination with infusional 5-FU, leucovorin (FOLFIFI) plus Bevacizumab, for cancer of the~     colon or rectum that has spread to the liver only and is currently not able to be removed by~     surgery. All of the drugs that will be received in this research study have been approved in~     the United States for colorectal cancer, that has spread to other areas of the body,~     including the liver. Another reason for doing this study is to see if the chemotherapy drugs~     FOLFIFI plus Bevacizumab can sufficiently decrease the size of the cancer in the liver so~     that any tumor remaining can be completely removed with surgery and, if it can be removed~     whether doing so will prolong the time it takes the cancer to return and/or prolong the life~     of these patients. This trial is also looking at the genes of people who take part in this~     study, to see if it is possible to find out characteristics that can help predict whose~     cancer will respond well or not so well, and who will have more or less side effects to this~     chemotherapy.~   "
263036|NCT00106041|"~     Improving end-of-life care is of critical importance to the VA as it faces an increasingly~     aging and dying veteran population. Previous work within and outside of the VA has~     demonstrated serious deficiencies in the quality of care delivered near the end of life.~     Moreover, veterans in the VA system suffer from a higher rate of chronic and life-limiting~     illnesses and decrements in health-related quality of life compared with the age-matched~     controls. In FY2000 approximately 104,000 enrolled veterans died in the U.S. including 27,200~     that died as inpatients in VA acute or chronic care medical wards. The care model on which~     the proposed study is based is theoretically sound and has been piloted in a study that~     suggested its use can help the VA achieve substantial quality improvement at reduced costs.~   "
263037|NCT00106028|"~     Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There~     are no approved drugs for the treatment of OI in children, even though some intravenous (IV)~     bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic~     study, data showed that risedronate was well tolerated in 28 children with OI. This three~     year study will test the safety and efficacy of risedronate in the treatment of children with~     OI. For the first year, patients will be randomized to the risedronate and placebo groups in~     a 2:1 ratio. For the second and third years of the study, all patients will receive~     risedronate.~   "
263038|NCT00106015|"~     The purpose of this study is to maintain a comprehensive registry of patients with the rare~     inherited bone marrow failure syndrome Diamond Blackfan anemia (DBA).~   "
263039|NCT00106002|"~     The purposes of this study are to determine whether pemetrexed can help patients with~     metastatic (cancer that has spread to other parts of the body) breast cancer, to determine~     any side effects that may be associated with the drug, to determine how much pemetrexed~     should be given to patients, and to collect DNA for future research regarding metastatic~     breast cancer. The collection of DNA is optional to the patient.~   "
263040|NCT00105989|"~     The purpose of this study is to assess the efficacy and safety of duloxetine compared with~     placebo in the prevention of depressive recurrences among patients with recurrent major~     depressive disorder.~   "
263041|NCT00105976|"~     The purpose of this clinical study is to see if an experimental drug, called MM-093, is safe~     and effective in the treatment of rheumatoid arthritis. MM-093 is a genetically engineered~     version of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have~     very small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both~     the mother and the fetus are much higher than normal. It has been observed that women with RA~     (Rheumatoid Arthritis) have fewer symptoms during pregnancy, particularly during the third~     trimester. At this time, the levels of AFP in the blood of the mother and fetus are the~     highest. This observation led researchers to begin examining AFP as a possible treatment for~     RA.~   "
263122|NCT00104871|"~     This phase II trial is studying how well bortezomib works in treating patients with~     metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth~   "
263042|NCT00105963|"~     This research project seeks to implement an early intervention program that can be effective~     in the prevention of Shaken Baby Syndrome (SBS) and infant abuse. Our hypothesis is that the~     Period of PURPLE Crying intervention program can reduce shaking and abuse of infants through~     changes in knowledge, attitudes and behaviors about early infant crying, especially~     inconsolable crying. In this 3-year project, we will implement and evaluate an intervention~     program in selected prenatal classes, hospitals, and primary care pediatric practices.~      In this randomized, controlled trial, we will enroll a total of 3000 women/families who are~     about to give birth or have just given birth to a healthy infant. At each of the three sites~     (newborn nursery, pediatrician offices and prenatal classes), we will enroll 1000 subjects.~     Half of all subjects will receive intervention materials (a video, pamphlet and bib/burp~     cloth) about infant crying. The other half, the control group, will receive comparable~     materials on infant safety. All subjects will be asked to complete a brief questionnaire at~     the time of enrollment (pre test), review the materials they receive, complete the Baby’s Day~     Diary for 4 days when the infant is 5 weeks of age and complete a telephone questionnaire~     (post test) when the infant is 8 weeks of age.~   "
263043|NCT00105950|"~     This study was designed to determine how effective and safe a new investigational drug,~     lapatinib, is in treating patients with treatment refractory or relapsed inflammatory breast~     cancer. Tumor tissue collected pre-treatment and at Day 28 will be examined for biologic~     activity by IHC (immunohistochemistry). Treatment will consist of daily oral therapy with~     lapatinib. A patient may continue treatment as long as they are receiving benefit. Blood~     samples for hematology and chemistry panels, MUGA/ECHO (multigated~     acquisition/echocardiogram) exams and physical exams will be performed throughout the study~     to monitor safety.~   "
263044|NCT00105937|"~     The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent~     fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid~     tolerant.~   "
263045|NCT00105911|"~     The literature and our preliminary studies found that in COPD patients, psychosocial factors~     affect quality of life (QOL) and functioning more than would be expected given the severity~     of their disease. To improve QOL and functioning in the approximately 50% of COPD patients~     with significant anxiety and/or depressive symptoms, interventions are needed. Much research~     documents the utility of cognitive behavioral therapy (CBT) in treating depression and~     anxiety, showing it to have promise as a self-management intervention to improve QOL in COPD~     patients.~   "
263046|NCT00105898|"~     This study is comparing the effectiveness of web-based care management to either~     telephone-based care management or internet access alone, in patients with poorly controlled~     diabetes mellitus.~   "
263047|NCT00105885|"~     The purpose of this study is to answer the following questions: (1) Does substituting brief,~     scheduled, clinician-initiated telephone calls (telephone care) for routine psychiatric~     medication management visits reduce overall healthcare utilization? (2) Is substituting~     brief, scheduled, clinician-initiated telephone calls (telephone care) for routine~     psychiatric medication management visits as effective as routine care?~   "
263048|NCT00105872|"~     Insomnia reduces quality of life, increases risks for other illnesses, and enhances health~     care costs/utilization. Several efficacy studies have shown that Cognitive-Behavioral Therapy~     (CBT) for insomnia improves sleep and diurnal complaints among highly screened samples;~     however, its effectiveness among �real-world� primary care patients is yet to be tested. This~     project is highly relevant to the VA health care mission, given the high prevalence of~     insomnia in middle-aged and older adults. Pilot data from this VA suggest that 40% of primary~     care patients report trouble sleeping.~   "
263049|NCT00105859|"~     Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury~     (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with~     SCI residing in the community. Epidemiological studies have found that 36-50% of all persons~     with SCI who develop pressure ulcers will develop a recurrence within the first year after~     initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al.,~     1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of~     treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer~     treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed~     $70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database,~     NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by~     either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if~     restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been~     associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997).~     Although little data exist describing the factors associated with recurrence following~     surgery, some investigators reported recurrence rates of 11%-29% in cases with post-operative~     complications and 6% to 61% in cases without post-operative complications (Mandrekas &~     Mastorakos, 1992; Relander & Palmer, 1988; Disa et al., 1992). In a retrospective study of 48~     veterans with SCI, investigators reported a 79% recurrence rate following surgery (Goodman et~     al., 1999).~   "
263050|NCT00105846|"~     Tele-home health care, which providers for video interactions between home-based veterans and~     home care nurses, is a potentially useful adjunct to home care services. However, few~     randomized trials have been conducted of this technology.~   "
263051|NCT00105833|"~     Depression is common in primary care settings, and associated with substantial physical and~     psychosocial impairment and increased healthcare utilization. Despite efforts to educate~     primary care providers, depression is often undetected or undertreated in primary care~     settings. The main objective of this study was to determine the impact of a low-intensity,~     care management intervention on depression treatment outcomes of patients in a VA primary~     care setting.~   "
263064|NCT00105664|"~     Data from VA-funded studies and the broader literature indicate that chronic stable angina~     (CSA) is prevalent, under recognized, under treated and associated with reduced quality of~     life. There are substantial opportunities for improving care of patients with this~     debilitating and potentially fatal problem. Because primary care providers manage most~     patients with CSA, efforts to improve care must necessarily involve the primary care delivery~     system. C3P is composed of a set of interventions employing a Collaborative Care Team model,~     which has been shown to be effective in managing other chronic illnesses in the primary care~     setting.~   "
263052|NCT00105820|"~     In spite of the impact on veteran�s health status and treatment cost, depression is~     under-diagnosed and under-treated. The goal of this study is to learn how to implement a~     previously tested, effective collaborative care model for improving the quality of depression~     care across multiple Veterans Integrated Service Networks (VISNs). To achieve this goal, we~     are conducting a randomized controlled trial of evidence-based quality improvement (EBQI), a~     dissemination method that relies on expert design and local implementation of evidence-based~     practice interventions. We hypothesize that EBQI will result in increased rates of assessment~     and appropriate management of depression. Results will be useful in designing realistic~     chronic care programs and performance measures for continuing care improvement.~   "
263053|NCT00105807|"~     Veterans are admitted to Veterans Health Administration (VA) Nursing Homes (NH) because~     impairment in their ability to perform activities of daily living (ADL) overwhelms their~     support system (family/friends) in the community. The etiologies of this impairment are, in~     part, due to chronic disease, deconditioning, and immobility. Yet, after admission, NH~     residents frequently have decreased levels of daily activity compared with their preadmission~     activity. Our preliminary observations suggest that dependent, frail residents improve in~     function in response to exercise in a NH setting.~   "
263054|NCT00105794|"~     During a psychiatric crisis, persons with severe mental illness (SMI) confront complex~     challenges concerning treatment choices and are often ill equipped or unable to make mental~     health care decisions. Psychiatric Advance Directives (PADs) are legal documents that allow~     competent persons to declare their treatment preferences in advance of a mental health~     crisis, when they may lose capacity to make reliable health care decisions. The use of PADs~     is consistent with recommendations of the President�s New Freedom Commission on Mental~     Illness and the Patient Self-Determination Act; 25 states have now adopted PAD legislation.~     VA does not have a specific policy for PADs or mechanisms to notify veterans of their right~     to prepare PADs. The downstream effects of PADs on patient care, crisis management, service~     use, and clinical outcomes are unknown.~   "
263055|NCT00105781|"~     Aging veterans with functional impairments followed in primary care clinics were randomized~     to counseling for a walking plus strength exercise home-based exercise program or to health~     education by a nurse. Exercise participants attended 3 intervention sessions totaling about~     100 minutes of contact with the nurse and a physical therapy assistant over 10 months. They~     were also asked to record walking and strength exercise on monthly calendars and received~     motivational automated phone messages. Education control patients discussed health topics of~     their choice with the nurse. Materials were based on National Institute of Aging materials~     currently available on the internet. After 10 months, the exercise participants reported more~     time spent in walking and strength exercise and accelerometer data indicated a greater~     increase in time spent in moderate or higher intensity activity per day. Participants who~     engaged in strength exercises improved more on functional fitness tests and quality of life~     after 10 months. Analyses from the cognitive sub-study remain incomplete.~   "
263056|NCT00105768|"~     VA investigators have described greater substance use at the beginning of the month when~     disability and other monthly checks are received. The proposed research addresses an~     important VA priority�seeing that veterans� funds are spent to improve veterans� quality of~     life and are not misspent on substances of abuse.~   "
263057|NCT00105755|"~     Foot ulcers remain the most common reason for hospital admission among veterans with~     diabetes. Healing and preventing these wounds should be a high priority for clinicians~     treating these high-risk patients. Previous work by the investigators has suggested that~     diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a~     thermometer.~   "
263058|NCT00105742|"~     Hearing impairment is one of the most common disabilities in veterans. The decreased ability~     to communicate is troubling in itself, but the strong association of hearing loss with~     functional decline and depression adds further to the burden on the hearing-impaired.~     Although hearing amplification improves quality of life, hearing evaluations are offered~     infrequently to older patients. Only 25 percent of patients with aidable hearing loss receive~     treatment. Up to 30 percent of patients who receive hearing aids do not use them. We contend~     that an effective formal screening program should identify hearing-impaired patients who are~     motivated to seek evaluation and who derive benefit from treatment.~   "
263059|NCT00105729|"~     Self-help groups (SHGs) have become an important component of the system of care for patients~     with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to~     lower relapse rates and less use of additional treatment services.~   "
263060|NCT00105716|"~     This four and a half year trial is evaluating both a patient and a provider intervention in a~     primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are:~     1) the proportion of veterans with BP control who receive either the provider-directed~     decision support or the patient health education and behavioral intervention will be~     increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control~     who receive both the provider-directed decision support and the patient health education and~     behavioral intervention will be increased by 25% as compared to usual care.~   "
263061|NCT00105703|"~     Despite established clinical practice guidelines, wide variations exist in the care of~     chronic heart failure (CHF) patients in Veterans Health Administration. Previous randomized,~     controlled studies have suggested that a nurse case management model may improve the outcomes~     of care for patients with CHF. However, these studies involved selected groups of patients~     (i.e., those who agreed to participate in randomized trials) in selected settings (i.e.,~     tertiary care facilities); so, the findings are not likely to be indicative of the true~     effectiveness of case management in a large population of CHF patients.~   "
263062|NCT00105690|"~     We adapted the collaborative care model using telemedicine (e.g., telephone, interactive~     video, electronic medical records) to support antidepressant therapy initiated by primary~     care providers in small rural practices and evaluated the effectiveness and~     cost-effectiveness of telemedicine-based collaborative care.~   "
263063|NCT00105677|"~     The purpose of this study is to examine cultural and clinical context factors in~     African-American and white veterans with knee or hip osteoarthritis with a focus on how these~     factors may be potentially modifiable determinants of willingness to consider joint~     replacement.~   "
263065|NCT00105651|"~     Data from the Surveillance, Epidemiology and End Results (SEER) cancer registry indicates~     that head and neck cancers (HN Ca) are nearly twice as common in veterans as non-veterans. HN~     Ca patients are at an increased risk for smoking, alcohol consumption and depression, all of~     which contribute to a further decline in their quality of life (QoL). In the HN Ca~     population, diagnosis and treatment of smoking, alcohol intake and depression are~     sub-optimal, thereby affecting QoL and survival. Numerous studies have documented that~     smoking, alcohol and depression are interrelated and research on multi-modal interventions~     has been suggested.~   "
263066|NCT00105638|"~     This study was designed to evaluate the impact of a Telehealth Education Program (TEP) on~     outpatient veterans with moderate to severe dementia and their spouse caregivers. The TEP is~     a program of education, coping skills, problem solving and support presented to caregivers of~     veterans with dementia by teleconference in 10 weekly, one-hour sessions. The TEP was based~     on a stress and coping model aimed to enhance the knowledge, skills and feelings of support~     of the caregivers who participated.~   "
263067|NCT00105625|"~     Hospital-acquired infections can occur five times as frequently in rehabilitation patients~     than in other hospital admissions. We postulate that this high infection rate may be due to~     nutritional problems frequently experienced in these patients. In this study, we examine the~     role of nutrition in inpatient geriatric rehabilitation patients' immune function and~     infection rates.~   "
263068|NCT00105612|"~     The purpose of this trial is to test whether a memory and organizational aid in the form of a~     document that summarizes and simplifies a study's key points can improve the decision-making~     abilities and competency of mild to early moderate Alzheimer's disease (AD) patients.~   "
263069|NCT00105599|"~     This study of the FairCare Program (FC) is designed to address end of life (EOL) care~     delivery issues by reducing barriers to effective EOL care among health care providers,~     family members, surrogates, and Chronic Heart Failure (CHF) patients using a comprehensive,~     multi-pronged approach delivered by a care coordinator and supported by an interdisciplinary~     team.~   "
263070|NCT00105586|"~     This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for~     generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD~     in elderly individuals.~   "
263071|NCT00105573|"~     This study will compare three interventions for depressed, low income mothers and determine~     which is most effective in treating maternal depression and in fostering development in~     infants.~   "
263072|NCT00105560|"~     RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a~     tumor was surgically removed may kill any remaining tumor cells and cause less damage to~     normal tissue.~      PURPOSE: This phase II trial is studying how well proton beam radiation therapy works in~     treating young patients who have undergone biopsy or surgery for medulloblastoma or~     pineoblastoma.~   "
263073|NCT00105547|"~     The purpose of the study is to evaluate the change in cognitive ability and activities of~     daily living in patients with Alzheimer's disease (AD) as measured by specific evaluations~     during 18 months of dosing.~   "
263074|NCT00105534|"~     The purpose of this study is to evaluate the clinical and microbial efficacy and safety of~     AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age~     and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be~     randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required~     for this study.~   "
263075|NCT00105521|"~     The purpose of this study is to test multiple doses of sarizotan to establish a dose with~     maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's~     disease participants.~   "
263076|NCT00105508|"~     The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is~     effective in the treatment of dyskinesia associated with dopaminergic treatment of~     Parkinson's disease (PD).~   "
263077|NCT00105495|"~     The purpose of this study is to determine whether deferiprone has superior efficacy in~     removing excess iron from the heart when compared with deferoxamine.~   "
263078|NCT00105482|"~     Weight gain after quitting smoking is an important barrier to treatment for many smokers.~     This study will test a drug called naltrexone with weight-concerned smokers to investigate~     whether or not this drug both improves smoking cessation quit rates and minimizes post quit~     weight gain.~   "
263079|NCT00105469|"~     The purpose of this study is to evaluate the clinical and microbial efficacy and safety of~     AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of~     age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will~     be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required~     for the study.~   "
263080|NCT00105456|"~     This is a prospective observational cohort study designed to describe effectiveness and~     safety (treatment outcomes and clinically significant cardiac adverse events, respectively)~     in patients with HER2-positive metastatic breast cancer.~   "
263081|NCT00105443|"~     The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find~     out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents~     the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics~     (PK) in patients with liver cancer.~   "
263082|NCT00105430|"~     This study will evaluate the effectiveness of deep brain stimulation (DBS) in treating~     primary generalized dystonia. Patients with dystonia have muscle spasms that cause~     uncontrolled twisting and repetitive movement or abnormal postures. Medical therapies are~     available, but not all patients get adequate relief from the abnormal movements or the pain~     associated with them. DBS is a surgical procedure that interrupts neuronal circuits in the~     Gpi and STN, areas of the basal ganglia of the brain that do not work correctly in patients~     with dystonia. The surgery results in decreased movement and therefore may lessen patients'~     symptoms and pain.~      Patients 7 years of age and older with generalized dystonia that does not respond to medical~     treatment may be eligible for this study. Candidates are screened with blood and urine tests,~     chest x-ray, and an electrocardiogram in patients 35 years of age or more.~      Participants undergo the following tests and procedures:~        -  Magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images~          of the brain. The patient lies on a table that is moved into the scanner (a narrow~          cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur~          during the scanning process. The procedure usually lasts about 45 to 90 minutes, during~          which the patient is asked to lie still for up to 15 minutes at a time.~        -  Transcranial magnetic stimulation. This procedure maps brain function. A wire coil is~          held on the scalp, and a brief electrical current is passed through the coil, creating a~          magnetic pulse that stimulates the brain. During the stimulation, the patient may be~          asked to tense certain muscles slightly or perform other simple actions. The stimulation~          may cause a twitch in muscles of the face, arm, or leg, and the patient may hear a click~          and feel a pulling sensation on the skin under the coil. During the stimulation,~          electrical activity of muscles is recorded with a computer, using electrodes attached to~          the skin with tape.~        -  Neurologic evaluation. Before and after DBS, the patient's dystonia, including voice~          strength and difficulty swallowing, are measured with a standardized rating scale.~        -  DBS treatment. Patients are randomly assigned to have electrodes implanted in either the~          Gpi or STN area of the basal ganglia. The electrodes are what stimulate the brain in DBS~          therapy. Before surgery, a frame is secured to the patient's head, and an MRI scan is~          done. DBS involves making two small incisions and two small holes in the skull, opening~          the lining around the brain, locating the Gpi or STN, securing the electrodes in place~          and connecting them to the pulse generator that is placed under the skin below the~          collar bone. Additionally, during the surgery, the patient is asked to move certain~          muscles. The muscle activity is recorded to gain a better understanding of the~          physiology of movement. After surgery, computed tomography (CT) and MRI scans are done~          to confirm placement of the electrodes.~        -  Stimulation and evaluation. After surgery, patients' movements are evaluated during and~          after stimulation. The changes in movement and function are videotaped and scored~          according to a rating scale. The optimal stimulation settings are determined and the~          stimulators are adjusted accordingly.~        -  Follow-up. Patients are evaluated, with videotaping, at 1, 2, 3, 6, 12, 18 and 24 months~          after surgery, and the stimulators are adjusted as needed.~   "
263095|NCT00105235|"~     Alemtuzumab is a man-made antibody used to treat certain blood disorders. Tacrolimus is a~     drug used to decrease immune system activity in people who have received organ transplants so~     that the new organ will not be rejected. This study will determine whether treatment with~     alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the~     recipient's health after liver transplantation in patients with end-stage liver disease, and~     whether gradual tapering of tacrolimus treatment is safe for these patients.~   "
263136|NCT00104676|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells.~      PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy~     regimens to see how well they work in treating patients with stage II or stage III~     non-seminomatous germ cell tumors.~   "
273059|NCT00015223|"~     The purpose of this study is the use of Methylphenidate in the treatment of cocaine~     dependence and Attention Deficit Hyperactivity Disorder (ADHD) comorbidity.~   "
263083|NCT00105417|"~     This study will evaluate whether interleukin-7 (IL-7) a drug similar to the natural IL-7~     protein produced by the body, is safe to use in people infected with HIV. IL-7 is important~     in immune system function. In humans, it can extend the life of immune cells called T-cells~     and increase their function and maturation; in mice, it can speed up immune system recovery~     following chemotherapy of transplantation; and in monkeys, it can make T-cells increase in~     numbers. If this study shows that IL-7 is safe, other trials will determine if it can improve~     the numbers or function of T-cells in HIV-infected people.~      Patients 18 years of age and older with HIV infection who have been taking anti-HIV~     medications for at least 12 months, whose CD4 counts are at least 100 cells/microliter, and~     whose viral load is no more than 50,000 copies/milliliter may be eligible for this study.~     Candidates are screened with a physical examination, blood and urine tests, including a blood~     test for HLA type (a genetic test of markers of the immune system), chest x-ray,~     electrocardiogram, and ultrasound of the spleen.~      Participants undergo the following tests and procedures during 9 visits, as follows:~      Pre-entry visit~        -  Brief physical examination, including examination of lymph nodes and spleen.~        -  Medical history, including questions about current and past medications.~        -  Urine pregnancy test for women who are able to become pregnant.~        -  Blood draw for viral load, immune responses, and other routine safety tests.~      Entry visit~        -  Complete physical examination, including examination of lymph nodes and spleen.~        -  Routine urine test and urine pregnancy test for women who are able to become pregnant.~        -  Blood draw for viral load, immune responses, and other routine safety tests.~        -  IL-7 dosing. Participants are randomly assigned to receive one of five doses of IL-7 (3,~          10, 30, 60 or 100 micrograms per kilogram of body weight) or placebo (a salt solution~          that does not contain IL-7). The dose may be given in one or more injections, with~          higher doses possibly requiring as many as seven or eight injections. The injections are~          given subcutaneously (under the skin), usually in the arm or leg. After the injection,~          patients are monitored closely for 12 hours for skin or allergic reactions. Blood is~          drawn before the injection and again at 0.5, 1, 1.5, 2, 2.5, 4, 8 and 12 hours after the~          injection to check blood levels of the study medication.~      Follow-up visits~      Patients come to the clinic 7 times during follow-up-every day for the first 4 days after the~     injection, then at 14 days, 4 weeks, and 8 weeks after the injection. At most study visits,~     patients have the following procedures:~        -  Brief physical examination, including examination of lymph nodes and spleen.~        -  Routine urine test and urine pregnancy test for women who are able to become pregnant.~        -  Blood draw for viral load, immune responses, and other routine safety tests.~        -  Blood test to measure the amount of study medication in the blood 1, 2, and 3 days after~          the injection~        -  Electrocardiogram 1 day after the injection~   "
263084|NCT00105404|"~     This study will compare the side effects of two treatments for diabetic macular edema, in~     which blood vessels in the retina (tissue that lines the back of the eye) become leaky and~     the retina and macula (the center part of the retina that is responsible for fine vision)~     swell, causing vision loss.~      Patients 18 years of age and older with diabetes mellitus and macular edema in one or both~     eyes may be eligible for this study. Candidates are screened with the following tests and~     procedures:~        -  Blood pressure measurement.~        -  Blood tests to measure HbA1c, a measure of the patient's diabetes control.~        -  Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens,~          retina and eye movements. The pupils are dilated with drops for this examination.~        -  Eye photography to help evaluate the status of the retina and changes that may occur in~          the future. Photographs of the inside of the eye are taken using a camera that flashes a~          bright light into the eye.~        -  Electroretinograms (ERG) to measure electrical responses generated in the retina.~          Wearing eye patches, the patient sits in a dark room for 30 minutes. Then, electrodes~          are taped to the forehead and an earlobe. The eye patches are removed, the surface of~          the eye is numbed with eye drops, and contact lenses are placed on the eyes. The patient~          looks inside a white globe that emits a series of light flashes for about 20 minutes.~          The contact lenses sense small electrical signals generated by the retina when the light~          flashes.~        -  Optical coherence tomography to measure retinal thickness. The eye is examined with a~          machine that produces cross-sectional pictures of the retina. These measurements are~          repeated during the study to determine whether retinal thickening is improving,~          worsening, or staying the same.~      Patients with macular edema in both eyes receive laser therapy in one eye and triamcinolone~     injections in the other. Patients with just one affected eye are randomly assigned to receive~     either laser or triamcinolone treatment. Those who receive only laser therapy may later~     receive triamcinolone injections in the second eye if it, too, develops macular edema.~      For the laser treatment, the eye surface is numbed with drops and a contact lens is placed on~     the eye during the laser beam application. Before the treatment, patients may have~     fluorescein angiography, in which pictures of the retina are taken using a yellow dye. The~     dye is injected into a vein and travels to the blood vessels in the eye. The camera flashes a~     blue light in the eye and takes pictures that show the amount of dye leakage into the retina.~     This helps guide the laser treatment. Patients return for follow-up visits every 4 months for~     3 years. If the macular edema is gone, no additional treatment is given and patients are~     followed as often as every 2 months. If the edema does return, additional treatments may be~     done at subsequent visits. Patients whose vision worsens considerably at the end of 1 year~     may be treated with a steroid injection, unless the other eye has also been treated with~     triamcinolone.~      For the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the~     pupil, and possibly and anesthetic injection, are put in the eye before the medicine is~     injected into the vitreous (jelly-like substance inside the eye). Then, the patient lies on~     his or her back for 30 minutes before being discharged home. Patients return for follow-up~     visits 4 days and 4 weeks after the injection, and then every 4 months for 3 years. Patients~     whose edema resolves are followed as often as every 2 months. Those whose edema returns have~     additional injections at the 4-month visits. Patients whose condition does not improve after~     1 year or whose vision worsens may undergo laser treatment.~   "
263085|NCT00105378|"~     The purpose of this study is to study the effects of nursing home visits in independently~     living elderly people on their functional performance and health-related quality of life. The~     general practitioner (GP) can refer elderly people to this intervention model after~     identification of a problem in cognition, mood, behavior, mobility, or nutrition. A~     specialist geriatric nurse visits the patients at home up to six times and coaches the~     patient in cooperation with the GP and geriatrician.~   "
263086|NCT00105365|"~     This trial will assess the ability of shoe inserts to relieve pain and disability in people~     with knee osteoarthritis (OA) in the inner (medial) aspect of the knee.~   "
263087|NCT00105352|"~     OBJECTIVE:~      This study is being conducted by the Type 1 Diabetes TrialNet Study Group, funded by the~     National Institutes of Health, in collaboration with the European C-Peptide Group. The goal~     is to evaluate comparability and reproducibility of measures of beta cell function in type 1~     diabetes comparing the mixed meal tolerance tests (MMTT) and glucagon stimulation test (GST).~     These two tests will be compared to assess the relationship between the MMTT and IV~     (intravenous) Glucagon stimulated C-peptide responses as measured by time to peak C-peptide~     and AUC (area under the curve) values.~      Based on the understanding that type 1 diabetes results from an immune mediated loss of~     pancreatic beta cells, therapeutic trials and newer measures of beta cell function can be~     evaluated as endpoints for clinical trials. Direct assessment of residual beta cell function~     is an appropriate endpoint, as retention of beta cell function in patients with T1D is known~     to result in improved glycemic control and reduced hypoglycemia, retinopathy and nephropathy.~     Endogenous beta cell function or insulin secretion is best measured by determination of~     C-peptide (which is co-secreted with insulin in a 1:1 molar ratio). Intervention studies over~     the past few decades have usually used measurement of C-peptide. However, the relationship~     between these or other measures of beta cell function has not been well studied. The relative~     advantages of one measure over another in terms of variability, sensitivity and burden to the~     subject is unknown. In addition, the optimal conditions for the conduct of the test need to~     be determined.~      An important goal is to develop an international consensus about the conduct of metabolic~     tests in the context of large, multicenter trials involving type 1 diabetes (T1D) by~     balancing the scientific data with the burden on the subject.~   "
263088|NCT00105339|"~     The main goal of this project is to develop and evaluate a simplified version of an HIV~     vaccine trial consent form designed for high-risk adolescents. The process will include: (1)~     reducing reading grade level by simplifying sentence structure and decreasing the use of~     infrequently used words; (2) re-organizing and categorizing the material for improved flow;~     and (3) developing a set of pictures to emphasize key concepts in the material. These~     materials will be tested among small focus groups of high-risk adolescents. A pre-post test~     design will be used to compare the simplified, adolescent-tailored consent form to one~     currently used in the National Institute of Allergy and Infection Diseases (NIAID) Vaccine~     Trial Information Booklet.~   "
263089|NCT00105326|"~     The primary objective of this study is to evaluate the amelioration of the sleep architecture~     of patients with schizophrenia and schizophrenia-related insomnia, treated with either 9 mg~     of extended-release paliperidone ER or placebo, using polysomnography.~   "
263090|NCT00105313|"~     For primary objectives, we will determine the MTD and examine clinical responses and immune~     cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.~      For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum~     concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and~     recovery of CD2 positive and total T-Cell populations.~   "
263091|NCT00105300|"~     The goal of this study is to test whether adalimumab can induce clinical remission in~     subjects with active Crohn's disease who have been initially treated with infliximab and~     either lost response or discontinued its use as a result of intolerance to the drug.~   "
263092|NCT00105287|"~     The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl~     when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.~   "
263093|NCT00105274|"~     Velocardiofacial syndrome, also known as 22q11.2 syndrome or DiGeorge syndrome, has been~     associated with many features such as a cleft palate, heart defects, and learning, speech and~     feeding problems. It is caused by the absence of a number of genes on chromosome 22, but the~     mechanism by which this inborn abnormality causes the clinical problems is not known.~      In this study by the National Institute of Mental Health and the Office of Rare Diseases, we~     are recruiting participants with 22q11.2 syndrome to come for a three-day stay to our main~     campus in Bethesda, MD, to participate in a study in which we will investigate the genetic~     makeup of their cells together with several studies of brain function with advanced research~     imaging. The goal of this study is to understand how the genes missing in 22q11.2 syndrome~     are related to the increased occurrence of psychiatric problems, such as psychosis, in this~     syndrome. Participants must be 18-50 years of age, have some high school education and not~     currently be taking antipsychotic medication. Travel costs to Bethesda for participants and~     an accompanying person will be paid, and participants are reimbursed for their time in~     participating in the study. A blood draw is required. All research procedures have been~     designated as minimal risk procedures.~   "
263094|NCT00105248|"~     The purpose of this study is to evaluate the effectiveness of a short training program for~     general practitioners in patient-centered communication to reduce antibiotic prescription for~     acute respiratory tract infections (ARTI).~   "
263096|NCT00105222|"~     This study will examine how nitrite infusions affect exercise tolerance (how much a person~     can exercise before having to stop). Exercise ability is limited by how fast oxygen can be~     delivered to the body and how fast the body can produce energy. Both of these processes are~     affected by nitric oxide (NO), a gas produced by cells that line blood vessels. NO is~     important in regulating blood vessel dilation, and consequently, blood flow. Nitrite may act~     as a storehouse for nitric oxide and be able to improve exercise tolerance.~      Healthy normal volunteers between 21 and 45 years of age who can use an exercise bicycle may~     be eligible for this study. Candidates are screened with a medical history, physical~     examination, electrocardiogram, breathing tests, blood tests, and a pregnancy test for women~     who are able to bear children. Pregnant women are excluded from the study. The screening~     session includes practice exercise on the bicycle.~      Participants exercise on a stationery exercise bicycle for about 30 minutes on each of two~     study days. During the test, they breathe in and out of a mouthpiece that allows inhaled and~     exhaled respiratory gases to be measured. Before subjects begin to exercise, a small tube is~     placed in the artery of their forearm inside the elbow. A longer tube called a central line~     is placed in a deeper vein in the neck after the area has been numbed. A thinner tube, called~     a pulmonary artery catheter, is placed through the central line and advanced into the~     chambers of the heart, through the heart valve, and into the lung artery. This catheter~     measures various pressures directly in the heart and lungs. Blood samples are drawn through~     the catheter also, to avoid the need for multiple needle sticks. Another tube is placed in~     the vein of the other arm to deliver medications.~      Thirty minutes after all the tubes are placed, a blood sample is drawn for baseline~     measurements. Then, either saline (sterile salt water) or nitrite is injected into the tube~     in the arm vein. Thirty minutes after the injection, the subject starts exercising on the~     bicycle. The work setting on the bicycle is increased every minute, and the subject pedals~     until he or she is too tired to continue. During the test, a small blood sample is collected~     every 2 minutes. Heart rate, blood pressure, and heart rhythms are continuously monitored.~      After the test on the first day, participants are admitted to the hospital to rest for the~     remainder of the afternoon and evening. The tubes are kept in place for the following~     morning, when the procedure is repeated exactly as before, except that subjects who received~     saline the first day are given nitrite the second day, and vice versa.~   "
263097|NCT00105209|"~     Rationale: Idiopathic pulmonary arterial hypertension (IPAH) is characterized by in situ~     thrombosis and increased thromboxane A2 (Tx-M) synthesis. While both may be attributable to~     abnormal platelet function, there are no studies of anti-platelet therapy in IPAH.~      Objectives: The purpose of this study is to assess the effects of aspirin (ASA) and~     clopidogrel on platelet function and eicosanoid metabolism in patients with IPAH.~   "
263098|NCT00105196|"~     The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess~     the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned~     open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder~     who demonstrate an incomplete response to a prospective eight week trial of the same assigned~     open-label marketed antidepressant therapy.~   "
263099|NCT00105183|"~     The purpose of this study is to assess the efficacy and safety of the study drug, known as~     ATG Fresenius S, which is sometimes called EZ-2053, to prevent a lung transplant~     patient's body from rejecting a transplanted lung or lungs.~   "
263100|NCT00105170|"~     This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors.~     This is the first study of hCBE-11 in humans and is designed to determine the safety and how~     well patients tolerate this investigational drug. The study duration is two years with~     treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and~     long-term follow-up contact every 3 months thereafter.~   "
263101|NCT00105157|"~     This study will investigate the safety and efficacy of different doses of an investigational~     drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral~     therapies.~   "
263102|NCT00105144|"~     The purpose of the study is to determine the safety and effectiveness of two dose levels of~     micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.~   "
263103|NCT00105131|"~     This study will explore the risks and causes of Parkinson's disease, a chronic progressive~     nervous system disorder. Patients typically have tremors, muscle weakness and a shuffling~     gait.~      Patients with Parkinson's disease, their relatives and healthy volunteers may be eligible for~     this study. Candidates must be 18 years of age or older. Patients whose parkinsonism is due~     to a secondary cause, such as infection or injury, and healthy volunteers who have a first~     degree family member (parent, grandparent, child, sibling) with Parkinson's disease are~     excluded from enrollment.~      Participants are asked about possible symptoms they may have and about their general health.~     They provide a blood sample to obtain DNA for genetic analysis to look for genetic~     differences that might be related to risks for Parkinson's disease. White blood cells may be~     treated in the laboratory to grow a cell line, which provides a source of substances in the~     blood without having to draw samples repeatedly.~   "
263104|NCT00105118|"~     This study will examine the effect of transcranial magnetic stimulation (TMS) on short-term~     memory in healthy adults. Healthy people use their brains to answer short-term memory~     questions in a different way than do patients with schizophrenia. Attention and memory~     deficits in schizophrenia patients significantly hamper their recovery and rehabilitation,~     yet there are no effective treatments for these impairments. TMS is a method of brain~     stimulation that may be able to change the electrical activity of the nerve cells of the~     brain and improve certain brain functions. This study will explore the effect of TMS on~     memory and perhaps discover brain processes that may be helpful in developing new ways to~     treat schizophrenia.~      Healthy volunteers between 18 and 55 years of age, excluding pregnant women, may be eligible~     for this study. Participants undergo the following tests and procedures:~        -  Medical history, physical examination, blood tests, electrocardiogram (EKG), and urine~          pregnancy test for women of childbearing age.~        -  Magnetic resonance imaging (MRI) and functional MRI (fMRI). These tests are done in~          participants who have not had structural and functional MRIs as participants in NIMH's~          2-day schizophrenia study within 90 days of entering the current study. MRI is done to~          locate the place in the brain to simulate with TMS and fMRI is done to look at brain~          activity while the subject solves short-term memory tasks. Both tests are done at the~          same session. Before the scan, four vitamin E capsules are taped to the subject's scalp.~          After the capsules are in place, the subject lies on a stretcher that is moved into the~          scanner - a narrow cylinder with a strong magnetic field. During the scan, subjects are~          asked to do some simple tests, such as watching pictures on a screen or pressing buttons~          in response to numbers they were shown a few seconds earlier. Scanning may take up to 2~          hours, but usually lasts between 45 and 90 minutes.~        -  TMS. For this procedure, subjects receive either active TMS or a sham procedure~          (placebo) that imitates TMS but does not use real electrical stimulation. For TMS, an~          insulated wire coil is placed on the scalp and a brief electrical current is passed~          through it. This generates magnetic pulses that travel through the scalp and skull and~          cause small electrical currents in the cortex, or outer part of the brain. The~          stimulation may cause muscle twitching in the scalp or face and may also cause small~          movement of the limbs. During the procedure, electrodes are taped to the scalp to record~          the electrical activity of the brain while short-term memory is tested. Two tests make~          up a set. There are a total of six test sets; each set takes about 3 minutes. Five~          periods of electrical stimulation are delivered before each test set. Each period of~          stimulation lasts 5 seconds, followed by a 10-second rest period. The stimulation-rest~          intervals continue until five periods of TMS have been applied. For the memory test,~          subjects press a key on a computer keyboard as quickly and accurately as possible in a~          test of their ability to remember a string of numbers, or letters.~        -  Questionnaires. At the beginning and end of the TMS session, participants fill out~          questionnaires that assess their mood, ability to concentrate, and level of anxiety.~   "
263105|NCT00105105|"~     The purpose of this study is to evaluate the effects of C-1073 (Mifepristone) on cognition in~     patients with Alzheimer's disease (AD) who are also taking an acetylcholinesterase inhibitor~     (Aricept, Exelon or Reminyl).~   "
263106|NCT00105092|"~     Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least~     one prior therapy.~   "
263107|NCT00105079|"~     This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir~     or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human~     immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment.~     Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice~     daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir~     400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study~     treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
263108|NCT00105066|"~     The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on~     the blood vessels of individuals with the Metabolic Syndrome (MeS).~   "
263119|NCT00104910|"~     This phase I trial is studying the side effects and best dose of cetuximab when given~     together with cisplatin and radiation therapy in treating patients with stage IB, stage II,~     stage III, or stage IVA cervical cancer. Monoclonal antibodies, such as cetuximab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs~     used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation~     therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.~     Giving cetuximab together with cisplatin and radiation therapy may kill more tumor cells.~   "
263153|NCT00104455|"~     This trial is conducted in the United States of America (USA). The purpose of this trial is~     to investigate the dose response to recombinant factor VIIa in healthy volunteers when~     administered for bleed.~   "
263109|NCT00105053|"~     This 2-phase study will determine the safety of treating patients with prostate cancer with~     the genetically engineered HyperAcute-Prostate cancer vaccine. It will establish the proper~     vaccine dose and will examine side effects and potential benefits of the treatment. The~     vaccine contains killed prostate cancer cells containing a mouse gene that causes the~     production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the~     immune response to the foreign substance will stimulate the immune system to attack the~     patient's own cancer cells that have similar proteins without this sugar pattern, causing the~     tumor to remain stable or shrink.~      Patients 19 years of age or older with hormone refractory prostate cancer that has recurred~     or no longer responds to standard treatment may be eligible for this study. Candidates will~     be screened with medical history and physical examination, blood tests, urinalysis, chest~     x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed.~      Participants will receive twelve vaccinations two weeks apart from each other. The vaccines~     will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase~     I of the study will treat successive groups of patients with increasing numbers of the~     vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase~     II will look for any beneficial effects of the vaccine given at the highest dose found to be~     safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine~     treatment. In addition, patient follow-up visits will be scheduled every 2 months for the~     remaining first year (6 months) after vaccination and then every 3 months for the next 2~     years for the following tests and procedures to evaluate treatment response and side effects:~        -  Medical history and physical examination~        -  Blood tests~        -  X-rays and various scans (nuclear medicine/CT/MRI)~        -  FACT-P Assessment questionnaire to measure the impact of treatment on the patient's~          general well-being. The questionnaire is administered before beginning treatment,~          monthly during treatment, and during follow-up visits after completing the treatment. It~          includes questions on the severity of prostate cancer symptoms and the ability to~          perform normal activities of daily life.~   "
263110|NCT00105040|"~     A 12-week Evaluation Period will be used to characterize potential cognitive and~     neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4~     - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive~     treatment with placebo.~   "
263111|NCT00105027|"~     The SCORE Study will compare the effectiveness and safety of standard care to intravitreal~     injection(s) of triamcinolone for treating macular edema (swelling of the central part of the~     retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein~     occlusion (BRVO).~   "
263112|NCT00105001|"~     This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil~     (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in~     patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of~     chemotherapy, such as fludarabine phosphate, and total-body-irradiation before a donor~     peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops~     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune system and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an~     immune response against the body's normal cells. Giving MMF and tacrolimus with or without~     sirolimus after transplant may stop this from happening.~   "
263113|NCT00104988|"~     RATIONALE: Thalidomide may stop the growth of melanoma by blocking blood flow to the tumor.~     It may also stimulate the immune system in different ways and stop tumor cells from growing.~     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     thalidomide together with temozolomide may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving thalidomide together with~     temozolomide works in treating patients with stage IV melanoma that cannot be removed by~     surgery.~   "
263114|NCT00104975|"~     RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell~     transplant helps stop the growth of cancer cells. It also stops the patient's immune system~     from rejecting the donor's stem cells. The donated stem cells may replace the patient's~     immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving~     an infusion of the donor's T cells that have been treated in the laboratory after the~     transplant may help increase this effect. Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving tacrolimus before and~     after transplant may stop this from happening.~      PURPOSE: This phase I trial is studying the side effects and best dose of donor lymphocytes~     when given after alemtuzumab and combination chemotherapy in treating patients who are~     undergoing donor stem cell transplant for hematologic cancer.~   "
263115|NCT00104962|"~     This phase I trial is studying the side effects and best dose of lenalidomide in treating~     young patients with relapsed or refractory solid tumors or myelodysplastic syndromes.~     Lenalidomide may stop the growth of solid tumors or myelodysplastic syndromes by blocking~     blood flow to the cancer. It may also stimulate the immune system in different ways and stop~     cancer cells from growing.~   "
263116|NCT00104949|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Trastuzumab may also stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well trastuzumab works in treating patients with~     locally advanced or metastatic synovial sarcoma.~   "
263117|NCT00104936|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery may be~     able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving~     radiation therapy or radiosurgery after surgery may kill any remaining tumor cells. It is not~     yet known whether radiation therapy or radiosurgery is more effective than observation alone~     in treating benign meningioma.~      PURPOSE: This randomized phase III trial is studying radiation therapy or radiosurgery to see~     how well they work compared to observation alone in treating patients with newly diagnosed,~     benign meningioma that has been partially removed by surgery.~   "
263118|NCT00104923|"~     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving fenretinide in a different way may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of intravenous~     fenretinide in treating patients with refractory or relapsed hematologic cancer.~   "
263120|NCT00104897|"~     RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~      PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin~     works in treating patients with metastatic malignant melanoma.~   "
264706|NCT00087841|"~     The purpose of this study is to determine the effectiveness of self-hypnotic relaxation on~     mental and physical distress during and after tumor treatment procedures.~   "
263123|NCT00104858|"~     This phase II trial studies how well fludarabine phosphate with radiation therapy and~     rituximab followed by donor stem cell infusions work in treating patients with high-risk~     chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with low side effects.~     Nonmyeloablative stem cell transplants use low doses of chemotherapy (fludarabine phosphate)~     and radiation to suppress the patient's immune system enough to prevent rejection of the~     donor's stem cells. Following infusion of donor stem cells, a mixture of the patient's and~     the donor's stem cells will exist and is called mixed chimerism. Donor cells will attack~     the patient's leukemia. This is called the graft-versus-leukemia effect. Rituximab will be~     given 3 days before and three times after infusing stem cells to help in controlling CLL~     early after transplant till the graft-versus-leukemia takes control. Further, rituximab~     could augment the graft-versus-leukemia effect by activating donor immune cells and hence~     improve disease control. Sometimes the transplanted cells from a donor can also attack the~     body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may~     stop this from happening.~   "
263124|NCT00104845|"~     RATIONALE: Vaccines made from DNA may make the body build an effective immune response to~     kill tumor cells.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine~     therapy in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.~   "
263125|NCT00104819|"~     RATIONALE: Vaccines made from a person's cancer cells may make the body build an effective~     immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may~     increase the number of immune cells found in bone marrow or peripheral blood and may~     stimulate the immune system in different ways and stop cancer cells from growing.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF~     works in treating patients with progressive B-cell non-Hodgkin's lymphoma.~   "
263126|NCT00104806|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Cholecalciferol (vitamin D) may help cancer cells become normal cells. Giving~     arsenic trioxide together with cholecalciferol (vitamin D) may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with~     cholecalciferol (vitamin D) works in treating patients with myelodysplastic syndromes.~   "
263127|NCT00104793|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving irinotecan together with carboplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin~     works in treating patients with newly diagnosed extensive-stage small cell lung cancer.~   "
263128|NCT00104780|"~     RATIONALE: Vaccines made from peptides may make the body build an effective immune response~     to kill tumor cells.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients~     with stage IIIB, stage IV, or recurrent non-small cell lung cancer.~   "
263129|NCT00104767|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It may also stimulate the immune system in different ways and stop~     tumor cells from growing.~      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib in~     treating patients with stage IIIB or stage IV non-small cell lung cancer.~   "
263130|NCT00104754|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~      PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients~     with small cell lung cancer.~   "
263131|NCT00104741|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as~     triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation~     therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide~     together with radiation therapy may be an effective treatment for prostate cancer. It is not~     yet known whether giving triptorelin and flutamide together with external-beam radiation~     therapy is more effective than external-beam radiation therapy alone in treating prostate~     cancer.~      PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and~     external-beam radiation therapy to see how well they work compared to external-beam radiation~     therapy alone in treating patients with stage II or stage III prostate cancer.~   "
263132|NCT00104728|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be~     removed.~      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who~     are undergoing surgery for stage I, stage II, or stage III non-small cell lung cancer.~   "
263133|NCT00104715|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin,~     may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may~     be an effective treatment for prostate cancer. It is not yet known whether giving hormone~     therapy together with docetaxel is more effective than hormone therapy alone in treating~     prostate cancer.~      PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how~     well they work compared to hormone therapy alone in treating patients with metastatic~     prostate cancer.~   "
263134|NCT00104702|"~     RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation~     therapy after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying how well radiation therapy works in treating older~     women who are undergoing surgery for stage I or stage II breast cancer.~   "
263135|NCT00104689|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing.~      PURPOSE: This phase II trial is studying how well giving capecitabine together with~     oxaliplatin works in treating older patients with metastatic colorectal cancer.~   "
263201|NCT00103779|"~     This is an open-label, multi-dose, Phase I, dose escalation study to define the safety~     profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or~     recurrent non-Hodgkin B-cell lymphomas.~   "
263137|NCT00104663|"~     PRION-1 aims to assess the activity and safety of Quinacrine (Mepacrine hydrochloride) in~     human prion disease. It also aims to establish an appropriate framework for the clinical~     assessment of therapeutic options for human prion disease that can be refined or expanded in~     the future, as new agents become available.~   "
263138|NCT00104650|"~     The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary~     N-telopeptide in advanced cancer subjects with bone metastases.~   "
263139|NCT00104637|"~     The purpose of this study is to determine if sildenafil improves the exercise capacity and~     lung function of patients with chronic obstructive pulmonary disease.~   "
263140|NCT00104624|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well docetaxel works in treating older women~     with metastatic breast cancer and whether it helps improve the ability to perform daily~     activities.~   "
263141|NCT00104611|"~     This trial will test the safety and efficacy of a rTMS device for the treatment of major~     depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect.~      It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in~     both academic and private research centers. It is comprised of three major phases: pre-study~     screening, acute treatment, and post-treatment taper. Eligible patients will be randomized to~     one of two rTMS treatment groups. One group will receive active rTMS treatment and one will~     receive an inactive, or sham, treatment. Each treatment takes about 45 minutes and is done on~     an outpatient basis. All trial related medical care is provided at no cost to the~     participant.~   "
263142|NCT00104598|"~     This is a randomized study of message framing in individuals beginning a smoking cessation~     program utilizing bupropion SR and brief counseling, videos, and pamphlets.~   "
263143|NCT00104585|"~     The purpose of this study is to investigate genetic and environmental risk factors that~     increase susceptibility to the development of early-onset Parkinson's disease (developed at~     or before age 50).~   "
263144|NCT00104572|"~     Background: Men≥65 years often produce lower levels of testosterone, meaning there is less~     testosterone circulating to the tissues of the body. This is associated with negative effects~     on muscle strength, bone density, sexual function, mood, and the ability to think to the best~     of one's ability. Testosterone replacement therapy often involves injections, patches, or~     gels that help to raise circulating testosterone levels, but these therapies often have side~     effects because they lead to imbalance of other hormones. Researchers have been studying the~     effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously~     increasing testosterone levels, as a treatment for the negative effects of decreased~     circulating testosterone levels that occur naturally with aging. Objectives: To evaluate~     whether anastrozole is as effective as testosterone gel in improving bone and muscle~     strength, hormone levels, and brain function in men over 65 years of age. Eligibility:~     Healthy men at least 65 years of age who have low levels of testosterone. Design: The study~     involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months,~     6 months, and 12 months. All participants will receive calcium and vitamin D supplements to~     take daily, and will be randomized to one of three groups:Testosterone gel and placebo~     tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have~     the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to~     evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle~     strength, bone density, and balance evaluation; imaging studies; cognitive testing; and~     questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six~     weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine~     tests; growth hormone, muscle strength, bone density, and balance evaluation; and~     questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six~     months: Blood and urine tests; muscle strength, bone density, and balance evaluation;~     cognitive testing; and questionnaires on quality of life, sexual function, depression, and~     urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength,~     bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires~     on quality of life, sexual function, depression, and urinary symptoms.~   "
263145|NCT00104559|"~     The purpose of this study is to test an interactive multimedia informed consent (iMIC)~     computer program to see if the program can generate a consent form that potential~     participants in an HIV trial can understand. This study will also determine if these~     participants prefer the computer-generated consent form and associated interactive tools to a~     standard consent form written by researchers.~      Study hypothesis: 1) Participants who receive information about clinical trials from iMIC~     Consent Tutorials will answer more questions about the trial correctly than participants who~     receive information about clinical trials from standard paper consent forms. 2) Participants~     will rate the iMIC Consent Tutorials as having better usability and user satisfaction than~     standard paper consent forms.~   "
263146|NCT00104546|"~     The purpose of this study is to test the feasibility and effectiveness of vitamin K~     injections into certain body parts for the treatment of painful menstruation.~   "
263147|NCT00104533|"~     Static magnetic therapy is increasingly used to alleviate pain; however, its efficacy has not~     been determined yet.~      The aims of this proposal are to evaluate the effect of magnetic therapy on pain intensity~     levels, opioid requirements, and opioid side effects.~   "
263148|NCT00104520|"~     The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation~     solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas~     aeruginosa (PA).~   "
263149|NCT00104507|"~     This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c~     receptor agonist, in clinical development as a potential treatment for obesity.~      The purpose of this study is to obtain preliminary assessment of the safety and efficacy of~     APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.~   "
263150|NCT00104494|"~     Zinc deficiency has occasionally been reported in CF, but the need for additional zinc is~     unclear. We will examine the effect of additional zinc supplements on zinc absorption, zinc~     excretion, zinc balance and zinc kinetics in children with CF. Twelve children with CF will~     receive additional zinc, and twelve will not. We will also compare the children with CF to 12~     healthy children without CF. We hypothesize that children with CF will have poor zinc~     absorption and high zinc excretion, leading to poor zinc balance and abnormal zinc kinetics.~     We hypothesize that those children with CF who are given zinc supplements will have higher~     zinc balance and more normal zinc kinetics than those without supplementation, and that zinc~     balance and zinc kinetics will be similar to healthy children.~   "
263151|NCT00104481|"~     The purpose of this study is to evaluate the effectiveness of group therapy for cigarette~     smoking cessation. The group meets for 8 sessions and includes education and group discussion~     about the effects of smoking and ways to cope with withdrawal symptoms and other challenges~     to maintaining abstinence. In one condition, the groups also learn techniques based on~     cognitive therapy, to help cope with negative feelings.~   "
263152|NCT00104468|"~     This is a phase I, single-arm, open-label, multi-center study of rising doses of Troxatyl™~     whose purpose is to determine the safety, tolerance, and pharmacokinetics, and to establish~     the recommended infusion schedule of Troxatyl™.~   "
263154|NCT00104442|"~     Alzheimer's disease is a medical illness that damages the brain and causes problems with~     memory, mood and behavior. A substance called acetylcholine (ACh), which is naturally~     produced in the body, plays an important role in the normal functioning of the brain. In~     subjects with Alzheimer's disease, the level of ACh is greatly reduced. Currently, there are~     three commonly prescribed drugs used for treating the symptoms of Alzheimer's disease by~     helping to maintain the level of ACh in the brain. This study will evaluate how much each of~     these drugs changes the levels of certain brain chemicals that are known to, or may play an~     important role in, Alzheimer's disease and its symptoms.~   "
263155|NCT00104429|"~     This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in~     combination with Combivir in HIV infected, untreated subjects.~   "
263156|NCT00104416|"~     This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine)~     extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC)~     seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like~     LAMICTAL extended-release tablets but do not contain active medication. In this study,~     LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.~   "
263157|NCT00104403|"~     This study was designed to assess the safety and efficacy of different dosages and~     administration schedules of an investigational agent administered over 3 days when added to~     standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer~     patients. Subjects will be asked to complete daily diaries while on study medication. In~     addition subjects will be required to return to the investigational site several times during~     the course of the study for follow up safety assessments which may include blood samples for~     hematology and chemistry evaluations as well as physical exams. A final assessment will be~     preformed on study Day 20-30 at which time the subject will complete the study.~   "
263158|NCT00104390|"~     The purpose of this study is to evaluate the residual allergenicity of Grass MATA (modified~     pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of~     the wheal response after skin prick testing with aqueous native and modified allergen,~     modified tyrosine adsorbed allergen and Grass MATA MPL (modified tyrosine adsorbed + MPL).~   "
263159|NCT00104377|"~     Grass MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide~     pre-seasonal specific immunotherapy for patients with hypersensitivity to grass and rye~     pollen. Different doses of Grass MATA will be administered and immunological changes~     following this treatment will be assessed.~   "
263160|NCT00104364|"~     The purpose of this trial is to study MK0731 in patients with recurrent or non-responsive~     solid tumors, or cancers for which standard therapy does not exist.~      This is an early phase trial and some specific protocol information is proprietary and not~     publicly available at this time. (Full information is available to trial participants).~   "
263161|NCT00104338|"~     The purpose of this study is to assess the safety and effectiveness of a new oral~     immunosuppressant agent compared to standard care in renal transplant patients diagnosed with~     BK nephropathy.~   "
263162|NCT00104325|"~     Background:~      - National Institute on Aging researchers are looking at studies that require large numbers~     of white blood cells for lab use. Standard blood samples do not provide enough white blood~     cells for these studies. Researchers want to use cytapheresis to collect white blood cells~     from volunteer donors. This procedure can collect larger amounts of white blood cells and~     reduce the amount of fluid and other cells that are lost.~      Objectives:~      - To use cytapheresis to collect white blood cells for study.~      Eligibility:~      - Healthy blood donors at least 18 years of age.~      Design:~        -  Participants will be screened according to the usual blood donation procedures.~        -  Participants will provide white blood cells through cytapheresis. The blood cells will~          be collected in a machine that separates the white blood cells from the rest of the~          blood. The rest of the blood will be returned to the donor.~        -  Participants may have this type of donation every 56 days (six times per year). They~          will be asked to become a repeat donor. A donation schedule may be set up.~        -  Once a year, participants will have blood tests to continue to be eligible as a donor.~   "
263163|NCT00104312|"~     The purpose of this study is to understand the factors that lead to muscle weakness with~     arthritis and aging.~   "
263164|NCT00104299|"~     Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of~     small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's~     granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used~     to treat certain types of cancer. The purpose of this study is to determine the effectiveness~     of rituximab in treating patients with WG and MPA.~      Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce~     disease remission by Month 6.~   "
263165|NCT00104286|"~     This is a phase I, single-arm, open-label, single-center study to establish the recommended~     infusion schedule for Troxatyl™ administered as a continuous infusion for 2-5 days to~     subjects with solid tumors.~   "
263166|NCT00104273|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose~     levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's~     Disease who are taking Aricept.~   "
263167|NCT00104260|"~     The primary objective is to evaluate the degree and frequency of response to Phenoptin™~     (sapropterin dihydrochloride), as demonstrated by a reduction in blood phenylalanine (Phe)~     level among subjects with phenylketonuria (PKU) who have elevated Phe levels. A secondary~     objective of this study is to evaluate the safety of Phenoptin™ treatment in this subject~     population, and identify individuals in this subject population who respond to Phenoptin™~     treatment with a reduction in blood Phe level.~   "
263168|NCT00104247|"~     The primary objective of this study is to evaluate the efficacy of Phenoptin™ (sapropterin~     dihydrochloride) in reducing blood phenylalanine (Phe) levels in subjects with~     phenylketonuria.~   "
263169|NCT00104234|"~     The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment~     in patients with Mucopolysaccharidosis VI.~   "
263170|NCT00104195|"~     The purpose of this trial is to study how teens with and without an anxiety disorder make~     decisions.~      This is a brain imaging study using functional magnetic resonance imaging (fMRI) in~     adolescents between the ages of 13 and 17.~   "
263171|NCT00104182|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin~     once a day (evening) when added to treatment with oral antidiabetic drugs in patients with~     Type 2 diabetes.~   "
263172|NCT00104169|"~     The purpose of this trial is to examine whether Epoetin Alfa, a hormone stimulating~     production of red blood cells, can reverse idiopathic anemia.~   "
263173|NCT00104156|"~     The purpose of this study is to evaluate the effectiveness of Qigong therapy, an ancient~     Chinese practice, for pain relief and symptom improvement in people with knee osteoarthritis~     (OA).~      Study hypotheses: 1) Qigong therapy will result in greater reduction of pain and greater~     symptom improvement than sham treatment. 2) Individuals with a history of complementary and~     alternative medicine (CAM) use will be more likely to experience benefits of Qigong therapy~     than those without such experience.~   "
263174|NCT00104143|"~     This study will compare the effect of A4I antagonist and placebo on MRI lesions,on clinical~     endpoints, and safety in patients with relapsing Multiple Sclerosis (MS). Eligible patients~     will be randomized to receive placebo or A4I antagonist, 20mg, 80mg or 300mg, po bid.~     Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the~     study. The anticipated time on study treatment is 3-12 months, and the target sample size is~     100-500 individuals.~   "
263175|NCT00104130|"~     The purpose of this trial is to study KOS-862 in men with metastatic prostate cancer who have~     failed a docetaxel-containing regimen.~   "
263176|NCT00104117|"~     The purpose of this study is to assess the safety and tolerability of XL999 in adults with~     advanced solid tumors.~   "
263177|NCT00104104|"~     The purpose of this trial is to study the safety of treating patients with multiple myeloma~     and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks~     for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.~   "
263178|NCT00104091|"~     Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate~     tumor cells and kill them without harming normal cells.~   "
263179|NCT00104078|"~     The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult~     patients with muscular dystrophy.~   "
263180|NCT00104065|"~     CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under~     investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring~     side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem~     cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy~     of CG53135-05 when administered as a single dose to patients at risk for developing oral~     mucositis.~   "
263181|NCT00104052|"~     The primary objective is to assess the safety, efficacy and tolerability of the combination~     of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary~     objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in~     pediatric subjects with chronic hepatitis C.~   "
263182|NCT00104039|"~     Purpose:~      This study will examine brain activity in children age 10-18 with disruptive behavior~     problems, including conduct disorder (CD), oppositional defiant disorder (ODD), and attention~     deficit hyperactivity disorder (ADHD), compared with children without behavioral problems.~     Our goal is to examine differences in how emotions, social situations, and problem-solving~     situations are processed in the brain across these groups of children.~   "
263183|NCT00104026|"~     This study will examine common features of gingival overgrowth (excessive growth of the gums~     around the teeth) that develops in patients with the hereditary form of the condition and in~     those who develop the condition as a side effect of medications. A better understanding of~     gingival overgrowth may help scientists develop medications with fewer oral side effects.~      Patients of any age with hereditary gingival fibromatosis and their blood relatives, and~     patients of any age with gingival overgrowth who are taking medications associated with~     development of the disorder, including phenytoin (diphenylhydantoin or Dilantin),~     cyclosporine, and calcium-channel blockers, may be eligible for this study.~      Participants undergo a medical and dental history, including a history of medication use;~     detailed examination of the teeth, periodontium, head, and neck; photographs of teeth with~     gingival overgrowth; dental x-rays; and blood tests. DNA is extracted from a blood sample to~     look for genes related to gingival overgrowth.~      Patients with gingival overgrowth are offered two options, as follows:~        -  Tissue biopsy: A tissue sample is taken from each affected site, with a maximum of three~          biopsies. For the procedure, lidocaine is first injected into the gum to numb the~          tissue. Then, a cookie-cutter instrument is pushed into the numbed skin, and a small~          piece of tissue is removed.~        -  Gingivectomy: Surgical removal of the overgrown gingival.~   "
263184|NCT00104013|"~     The purpose of this study is to assess xaliproden's potential capacity of slowing the~     deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's~     disease. The patients participating in this study will take orally once daily xaliproden or~     placebo (inactive substance pill).~   "
263185|NCT00104000|"~     This study will examine whether surface electrical stimulation on the skin of the throat~     will: 1) move the larynx (voice box); 2) move the vocal folds in the larynx; and 3) cause~     less movement of the larynx when applied during swallowing. It is important that the larynx~     moves up and forward while swallowing so that food does not go into the airway. A device~     called VitalStim® (Registered Trademark), which provides electrical stimulation to the skin~     on the neck and under the chin, is widely used to treat people who have problems swallowing.~     This study will determine if VitalStim can move the voice box or the vocal folds in the~     larynx. This information is important for patients who have long-term problems raising or~     closing their larynxes when they swallow.~      Healthy volunteers between 20 and 60 years of age may be eligible for this study. Candidates~     are screened with a medical history, physical examination, electrocardiogram, and~     nasoendoscopy. For the latter procedure, the inside of the subject's nose is sprayed with a~     decongestant, opening the nasal passages. A small flexible tube called a nasoendoscope is~     passed through the nose to the back of the throat. The scope allows observation of the larynx~     while the subject speaks, sings, whistles and makes prolonged vowel sounds.~      Participants are familiarized with the VitalStim device before beginning the experimental~     procedures. The device consists of two sets of electrodes and a stimulation unit. The~     electrodes are placed on the neck and under the chin. Stimulation causes different~     sensations, according to the intensity level. They include tingling/crawling, vibrating~     warm/burning, and grabbing. Subjects then undergo the following procedures:~        -  Nasoendoscopy with muscle stimulation: The inside of the nose is sprayed with a~          decongestant and the nasoendoscope is passed through one nostril to the back of the~          throat. Electrodes are placed on the throat area and under the chin. Stimulation is~          delivered 10 times at various places on the neck and under the chin while the subject~          sits quietly. This test shows if the vocal folds in the voice box move with surface~          electrical stimulation.~        -  Videofluoroscopy with muscle stimulation at rest and during swallowing: This is an x-ray~          study of the head and neck during swallowing and at rest to determine how stimulation~          affects the level of the voice box in the neck. Electrodes are placed under the chin and~          on the throat. The subject swallows 5 milliliters of barium, a contrast material that~          can be seen easily on x-ray. The x-ray machine is turned on for a few seconds at a time~          during each swallow of the barium and another 10 times while the subject is remaining~          still without swallowing.~   "
263186|NCT00103987|"~     This study will examine brain and noradrenaline function in panic disorder. Noradrenaline is~     a brain chemical that is involved in the regulation of emotion, anxiety, sleep, stress~     hormones such as cortisol, and other body functions that are disturbed in panic disorder.~      Healthy normal volunteers and patients with panic disorder between 18 and 60 years of age may~     be eligible for this study. Candidates are screened with psychiatric and medical histories, a~     physical examination, blood and urine tests, and an electrocardiogram.~      Participants undergo the following tests and procedures:~        -  Blood draw to obtain DNA for genetic studies of panic disorder - particularly of a gene~          that helps control noradrenaline activity - and to grow cell lines that can be frozen~          and used for future research on the disorder.~        -  Magnetic resonance imaging: MRI uses a magnetic field and radio waves to produce images~          of body tissues and organs. For this procedure, the subject lies on a table that is~          moved into the scanner (a narrow cylinder), and wears earplugs to muffle loud knocking~          and thumping sounds that occur during the scanning process. The procedure lasts about 60~          minutes, during which the patient is asked to lie still for 10 to 15 minutes at a time.~        -  Yohimbine injection with PET scanning: Catheters (plastic tubes) are placed in two~          veins, one to administer yohimbine, a drug that increases noradrenaline activity in the~          body for about 60 minutes, and one to draw blood samples. Yohimbine often causes~          temporary trembling, goosebumps, and clammy palms, and may cause emotions such as~          elation, anxiety, panic attacks, or depression. During yohimbine administration,~          subjects undergo positron emission tomography (PET) scanning. PET uses small amounts of~          a radioactive chemical called [fluoro-18]-fluorodeoxyglucose that labels active areas~          of the brain, showing patterns of glucose (sugar) metabolism. For the procedure, the~          subject lies on the scanner bed, with a special mask fitted to his or her head and~          attached to the bed to help keep the head still. A brief transmission scan is done~          just before the radioactive tracer is injected in order to calibrate the scanner. After~          the tracer is injected through the catheter, pictures are taken for about an hour, while~          the subject lies still on the scanner bed.~        -  Saline injection with PET scanning: The procedure is the same as that described above,~          except a saline solution is administered as placebo instead of yohimbine.~   "
263187|NCT00103974|"~     This research study is being done to evaluate the safety of BHT-3009 alone and when combined~     with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).~   "
263188|NCT00103961|"~     This is a long-term follow-up study of people who are identified during acute or recent HIV~     infection and are being followed at clinical research sites associated with the Acute HIV~     Infection and Early Disease Research Program (AIEDRP). The purpose of this study is to~     collect data on the immunological and virologic responses that occur early in the course of~     HIV infection in treatment-naive and treatment-experienced HIV infected adults.~      Study hypothesis: This study will examine the immunological responses that occur early in the~     course of HIV infection in treated and untreated individuals. The long-term follow-up of~     these subjects will help identify host immunological and genetic factors along with~     therapeutic strategies associated with control of viremia and delayed disease progression. In~     addition, this cohort will provide the recruiting mechanism to support future trials of~     therapy to restore immune function. Furthermore, this cohort will provide a population~     suitable to monitoring changing patterns in the transmission of drug resistant viral strains~     while also evaluating ongoing behavioral risk factors associated with HIV transmission.~   "
263189|NCT00103948|"~     This is an 18-week, prospective, multi-center, randomized, double-blind, placebo-controlled,~     (1:1) parallel-group study.~   "
263190|NCT00103935|"~     Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily~     dosage form currently under investigation as a potential treatment for people with type 2~     diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of~     Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes~     mellitus.~   "
263191|NCT00103922|"~     This study was designed to determine if the investigational drug is effective and safe in~     individuals with COPD (chronic pulmonary disease)~   "
263192|NCT00103896|"~     This is Phase II of a three stage project whose overall goals are to develop viable~     community-based HIV prevention interventions and to form and maintain the necessary community~     collaborations to support such Adolescent Trials Network (ATN) research activities.~      This phase will describe specific locations within high-risk areas where youth, ages 12-24,~     spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at~     these venues will be assessed by administering anonymous computerized interviews to eligible~     and willing youth. This information will be shared with community partners during scheduled~     working group meetings.~   "
263193|NCT00103883|"~     Identifying young people with early HIV-1 infection is important for increasing linkage to~     care, for behavioral counseling, and for enrolling individuals into programs that can provide~     effective interventions to disease progression and improve outcome. This study will develop~     and evaluate a saliva-based sensitive/less sensitive (S/LS) assay for differentiating persons~     with recent HIV-1 infection (less than 133 days) from those with established HIV-1 infection.~   "
263194|NCT00103870|"~     The purpose of this study is to determine whether engaging in music listening tasks can~     reduce the perception of pain and provide nondrug pain relief.~      Study hypotheses: 1) Performing a highly engaging listening task reduces psychophysiological~     arousal to painful stimuli. 2) Psychophysiological arousal to painful stimuli is a function~     of the complexity of the auditory signal. 3) Signal complexity and task difficulty interact~     to produce the greatest engagement and maximum reduction in psychophysiological arousal to~     painful stimuli.~   "
263195|NCT00103857|"~     The purpose of this study is to determine the safety and effectiveness of an investigational~     drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).~   "
263196|NCT00103844|"~     The primary purpose of this study is to estimate the major cytogenetic response rates of~     BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome~     positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of~     400-600 mg/d.~   "
263197|NCT00103831|"~     A phase I-II dose ranging study of BMS-275183 (oral taxane) in combination with pemetrexed~     (Alimta) in patients with recurrent Non-Small Cell Lung Cancer (NSCLC). The safety and~     efficacy of this combination will be studied.~   "
263198|NCT00103818|"~     The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia~     (a sleep disorder).~   "
263199|NCT00103805|"~     The purpose of this study is to determine whether the non-daily administration of levodopa is~     effective in boosting semantic language acquisition in healthy subjects.~   "
263200|NCT00103792|"~     The purpose of this study is to determine the efficacy and safety of a new drug,~     mycophenolate mofetil, for the treatment of relapses of ANCA-associated vasculitis (Wegener's~     granulomatosis or microscopic polyangiitis). Therefore, we compare the standard therapy with~     cyclophosphamide to mycophenolate mofetil.~      The investigators expect mycophenolate mofetil to be less toxic and almost equally effective~     as cyclophosphamide.~   "
273060|NCT00015210|"~     The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and~     depression comorbidity.~   "
263203|NCT00103753|"~     Thalassemia major is a genetic disorder affecting hemoglobin synthesis, rendering individuals~     dependent upon lifelong blood transfusions. Consequently, iron overload occurs and patients~     have shortened life expectancy with the most common cause of death being heart failure. This~     trial tests whether the combination of traditional therapy (deferoxamine) with a newer drug~     (deferiprone) will prove more effective in removing cardiac iron than deferoxamine alone.~   "
263204|NCT00103740|"~     The primary objective of this core study was to show non-inferiority of zoledronic acid to~     risedronate, with respect to the proportion of patients who achieved therapeutic response.~     The extended observation period included participants of the core study who responded to~     treatment.~   "
263205|NCT00103727|"~     This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective~     compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative~     symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks~     and will then return for a follow-up visit 2 weeks later. About 275 patients with~     schizophrenia will be enrolled in this study.~   "
263206|NCT00103714|"~     The objectives of this study are to evaluate the safety, tolerability and preliminary~     efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in~     patients with cystic fibrosis (CF) lung disease.~   "
263207|NCT00103701|"~     The purpose of this clinical research study is to understand the safety and efficacy of~     BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia~     (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or~     intolerant of imatinib mesylate (Gleevec).~   "
263208|NCT00103675|"~     The purpose of this study is to develop and test a sensor system capable of measuring~     acupuncture needle manipulation and torque in a clinical setting.~      Study hypothesis: Torque will be greater on the side of the back with musculoskeletal pain~     compared with the side without pain.~   "
263209|NCT00103662|"~     The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and~     granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than~     G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma~     patients for autologous transplantation.~   "
263210|NCT00103649|"~     The purpose of this study is to assess xaliproden's potential capacity of slowing the~     deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's~     disease. The patients participating in this study will take orally once daily xaliproden or~     placebo (inactive substance pill).~   "
263211|NCT00103636|"~     The purpose of this study is to investigate the effects of extending the dwell time of~     peripheral intravenous cannulas on clinical outcomes and cost.~   "
263212|NCT00103623|"~     Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV~     commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated~     population of patients receiving Plenaxis®. The purpose of the study is to estimate the~     incidence of immediate-onset systemic allergic reactions in the indicated population~     receiving Plenaxis® and to determine whether the hazard rate changes over time.~   "
263213|NCT00103610|"~     The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and~     granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF~     alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma~     patients for autologous transplantation.~   "
263214|NCT00103597|"~     Patients with Parkinson's Disease or Multiple System Atrophy (MSA), and symptoms of~     orthostatic hypotension, are eligible for the study. Each patient will have three weeks of~     conservative therapy, three weeks of therapy with fludrocortisone, and three weeks of therapy~     with domperidone. Autonomic testing, a symptom questionnaire, bedside blood pressure testing,~     and Unified Parkinson Disease Rating Scale (UPDRS) will be performed after each intervention.~   "
263215|NCT00103584|"~     This is a Phase I/II study evaluating the safety and immunogenicity of LC16m8, a modified~     vaccinia vaccine. After consent and thorough screening (including safety labs, EKG, and~     medical history), healthy, previously unvaccinated volunteers between the ages of 18-34 will~     receive a single vaccination of either LC16m8 or the current US-licensed smallpox vaccine,~     Dryvax. Volunteers will be blindly randomized to a treatment group in a 4:1 ratio (4 LC16m8~     to 1 Dryvax recipient). Follow-up clinical evaluations, laboratory testing, EKGs and cardiac~     assessments will be done at regularly scheduled follow-up visits for 1 year after~     vaccination.~   "
263216|NCT00103571|"~     The purposes of this study are to assess similarities and differences in the efficacy (how~     well the drug works), safety, and side effects of olanzapine and aripiprazole in patients~     with schizophrenia, schizoaffective disorder, or schizophreniform disorder.~   "
263217|NCT00103558|"~     This is an open label, Phase I/II, dose escalation research study of an investigational~     product called lumiliximab, given with FDA (Food and Drug Administration) approved products~     fludarabine, cyclophosphamide, and rituximab (FCR). The study duration is 17 visits over 42~     months or until your disease progresses and you require additional CLL therapy. The total~     duration of participation in the study will be approximately 4 years, however your disease~     status will be followed indefinitely (forever).~   "
263218|NCT00103545|"~     The purpose of this study is to use an immunologic approach following the treatment for~     recurrent disease in patients with ovarian, fallopian tube, or peritoneal cancer.~   "
263219|NCT00103532|"~     Risk behaviors and their associated adverse health outcomes are becoming increasingly~     problematic among HIV-infected youth. This study is being conducted to test whether a brief~     motivational enhancement (ME) intervention will help reduce health risk behaviors (drug and~     alcohol use, sexual risk behavior, poor adherence to medications) among HIV+ youth.~   "
263220|NCT00103519|"~     This study will assess the safety and efficacy of DITPA relative to placebo in patients with~     New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) who have low~     serum T3. DITPA is an investigational agent.~   "
263221|NCT00103506|"~     The purpose of this study is to evaluate time to progression, overall survival, response rate~     and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE~     vs. VELCADE monotherapy.~   "
263438|NCT00100542|"~     The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health~     problems or make mental health problems worse in children and adolescents who were infected~     with HIV at birth.~   "
263222|NCT00103493|"~     The purpose of this study is to evaluate whether an oral health education program that is~     tailored to caregivers' understanding and acceptance of information on how to prevent tooth~     decay will lead to improvement in behaviors conducive to good oral health and reduction in~     tooth decay in his or her children.~   "
263223|NCT00103467|"~     The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102~     vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.~   "
263224|NCT00103454|"~     The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg~     once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent~     subjects (12 years of age and older) with perennial allergic rhinitis (PAR).~   "
263225|NCT00103428|"~     V-0039 is a Phase 1/2 dose escalation trial of CG7870 in combination with Docetaxel in~     metastatic hormone-refractory patients who have not received chemotherapy.~      All patients will receive docetaxel. In the dose escalation phase of the study, patients will~     receive treatment intravenously with CG7870 at one of up to four dose levels. In the Phase 2~     portion of this study, additional patients will be added at the maximum tolerated dose that~     is determined in Phase 1.~   "
263226|NCT00103415|"~     During one year, 5-8% of the population will suffer from major depression. Some of the key~     symptoms are loss of interest in daily activities, loss of energy and sleeping disturbances.~     The financial consequences of this disease is estimated to be more than 30 million pounds per~     year in Great Britain and USA alone. There is an increasing interest in the effect exercise~     has on depression. Smaller studies indicate that exercise is a good treatment for depression.~     This study will be a large scale randomized trial and will hopefully bring important~     knowledge on the effects exercise has on depression.~      We will compare the effect endurance training, weight-lifting exercise and a control group~     has on depressive symptoms after 4 months training, twice a week.~   "
263227|NCT00103402|"~     The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the~     alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic~     prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg~     capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH).~     The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH~     has been documented in a number of placebo-controlled studies. A number of small studies have~     also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade~     mechanism. This study will enable further testing of this hypothesis~   "
263228|NCT00103389|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88~     may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. It may~     also help docetaxel work better by making tumor cells more sensitive to the drug. Giving~     docetaxel together with PI-88 may kill more tumor cells. It is not yet known whether giving~     docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small~     cell lung cancer.~      PURPOSE: This randomized phase II trial is studying docetaxel and PI-88 to see how well they~     work when given together compared to docetaxel alone in treating patients with stage IIIB or~     stage IV non-small cell lung cancer.~   "
263229|NCT00103376|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such~     as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making~     androgens. Giving bortezomib with hormone therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone~     therapy works in treating patients with relapsed prostate cancer.~   "
263230|NCT00103363|"~     RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early~     and plan better treatment for lung cancer.~      PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy~     smokers for lung cancer.~   "
263231|NCT00103350|"~     TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis~     of this study is that TG100-115 can be given safely to patients who suffer a heart attack and~     undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces~     heart muscle damage.~   "
263232|NCT00103337|"~     This randomized phase II trial is studying how well cilengitide works in treating patients~     with metastatic prostate cancer. Cilengitide may stop the growth of prostate cancer by~     blocking blood flow to the tumor~   "
263233|NCT00103324|"~     This phase II trial is studying how well lapatinib works in treating patients with locally~     advanced or metastatic stomach cancer. Lapatinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth~   "
263234|NCT00103311|"~     This randomized phase II trial is studying how well SB-715992 works in treating patients with~     advanced or metastatic colorectal cancer. Drugs used in chemotherapy, such as SB-715992, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~   "
263235|NCT00103298|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, leucovorin, oxaliplatin, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     and giving the drugs in different ways may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan~     followed by combination chemotherapy works in treating patients with unresectable liver~     metastases from colorectal cancer.~   "
263236|NCT00103285|"~     This randomized phase III trial is studying different combination chemotherapy regimens and~     comparing how well they work in treating patients with newly diagnosed acute lymphoblastic~     leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more cancer cells.~   "
263257|NCT00102973|"~     The purpose of this research study is to determine if TLK286 given in combination with~     carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent~     ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is~     refractory or resistant to platinum chemotherapy.~   "
263258|NCT00102960|"~     The purpose of this study is to compare the effects of anti-HIV drug courses of different~     lengths in infants who became HIV infected at birth.~   "
263237|NCT00103272|"~     This phase I trial is studying the side effects and best dose of~     17-N-allylamino-17-demethoxygeldanamycin and bortezomib in treating patients with relapsed or~     refractory hematologic cancer. Drugs used in chemotherapy, such as~     17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving~     17-N-allylamino-17-demethoxygeldanamycin together with bortezomib may kill more cancer cells.~   "
263238|NCT00103259|"~     This randomized phase II trial is studying bortezomib and irinotecan to see how well they~     work compared to bortezomib alone in treating patients with locally recurrent or metastatic~     squamous cell carcinoma of the head and neck. Bortezomib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     irinotecan, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving bortezomib together with irinotecan may kill~     more tumor cells. It is not yet known whether giving bortezomib together with irinotecan is~     more effective than bortezomib alone in treating head and neck cancer.~   "
263239|NCT00103246|"~     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a~     certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy~     using silicon phthalocyanine 4 may be effective against skin cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic~     therapy using silicon phthalocyanine 4 in treating patients with actinic keratosis, Bowen's~     disease, skin cancer, or stage I or stage II mycosis fungoides.~   "
263240|NCT00103233|"~     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Trastuzumab may also help vinorelbine work~     better by making tumor cells more sensitive to the drug. Giving vinorelbine together with~     trastuzumab may be an effective treatment for breast cancer. It is not yet known whether~     giving vinorelbine together with trastuzumab is more effective than vinorelbine alone in~     treating breast cancer.~      PURPOSE: This randomized phase III trial is studying vinorelbine and trastuzumab to see how~     well they work compared to vinorelbine alone in treating women with progressive metastatic~     breast cancer.~   "
263241|NCT00103220|"~     This phase I trial is studying the side effects and best dose of SJG-136 in treating patients~     with advanced solid tumors. Drugs used in chemotherapy, such as SJG-136, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~   "
263242|NCT00103207|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them.~      PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with~     recurrent or stage IIIB or stage IV lung cancer.~   "
263243|NCT00103194|"~     This phase II trial studies how well lapatinib ditosylate works in treating patients with a~     rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that~     prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or~     prevent the progression of prostate cancer.~   "
263244|NCT00103181|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy in different ways may kill any tumor cells that remain after surgery. It is not yet~     known whether whole breast radiation therapy is more effective than partial breast radiation~     therapy in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see~     how well it works compared to partial breast radiation therapy in treating women who have~     undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.~   "
263245|NCT00103168|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining~     tumor cells. It is not yet known whether imatinib mesylate is more effective than observation~     only in treating gastrointestinal stromal tumor.~      PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it~     works compared to observation only in treating patients who have undergone surgery for~     localized gastrointestinal stromal tumor.~   "
263246|NCT00103155|"~     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor~     cells. Ultrasound-guided radiofrequency ablation may be effective treatment for thyroid~     cancer.~      PURPOSE: This phase I trial is studying the side effects of radiofrequency ablation in~     treating patients who are undergoing surgery for thyroid cancer.~   "
263247|NCT00103142|"~     RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make~     the body build an effective immune response to kill tumor cells. Biological therapies, such~     as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system~     in different ways and stop tumor cells from growing. Combining different types of biological~     therapies may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with~     dendritic cells to see how well it works compared to giving vaccine therapy together with~     GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by~     surgery.~   "
263248|NCT00103116|"~     RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may~     make the body build an effective immune response to kill tumor cells.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients~     with stage I, stage II, or stage III non-small cell lung cancer.~   "
263249|NCT00103103|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib together with~     fluorouracil and leucovorin works in treating patients with metastatic or unresectable~     stomach cancer.~   "
263250|NCT00103090|"~     RATIONALE: Drugs, such as fenretinide and lonafarnib, may stop the growth of head and neck~     cancer by blocking blood flow to the tumor. Fenretinide may also help tumor cells become~     normal cells. Lonafarnib may also stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving fenretinide together with lonafarnib may kill more~     tumor cells.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of~     fenretinide and lonafarnib in treating patients with advanced or recurrent head and neck~     cancer.~   "
263251|NCT00103051|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving gemcitabine and cisplatin together with gefitinib before surgery may~     shrink the tumor so it can be removed.~      PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together~     with gefitinib works in treating patients who are undergoing surgery for stage III non-small~     cell lung cancer.~   "
263252|NCT00103038|"~     This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent~     ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in~     patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic~     procedures, such as MRI, may help find and diagnose brain tumors and find out how far the~     disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite~     consists of small iron particles taken by the blood stream to the brain and to the area of~     the tumor. It may help visualize the blood flow going through the tumor better than the~     standard substance gadolinium-based contrast agent.~   "
263253|NCT00103025|"~     This study will determine the dose of sodium nitrite that can safely be used to prevent~     constriction, or tightening, of the arteries. Narrowed arteries in the brain can cause~     stroke. Animal studies show that nitrite injections improve blood flow and that injections~     over long periods of time prevent damage to the arteries in the brain; however, there is no~     information on the effects of prolonged nitrite infusion in humans. This study will establish~     the safe dose and side effects of nitrite infusion in humans.~      Healthy normal volunteers between 21 and 60 years of age may be eligible for this study.~     Candidates are screened for high or low blood pressure, aspirin use, pregnancy, and blood~     levels of nitrite and methemoglobin (a substance that temporarily and slightly lowers the~     oxygen carried in the red blood cells). Pregnant women are excluded from the study.~      Participants are admitted to the Clinical Center for 16 1/4 days, the first 2 days in the~     hospital's intensive care unit (ICU). Upon admission they provide a medical history, have~     physical and cardiovascular examinations, and blood tests. For the infusion procedure, a~     catheter (thin plastic tube) is inserted into an artery in the wrist or the crease of the~     elbow to measure blood pressure, and catheters are placed in a vein in each arm for~     administering the nitrite and withdrawing blood samples.~      In the morning of day 1, after initial blood pressure and heart rate measurements are taken~     and a blood sample is drawn, a saline (salt water) infusion is started. Blood pressure and~     heart rate are monitored every 30 minutes for 6 hours, then every hour for 6 hours, then~     every 2 hours for 12 hours. Blood samples are collected every 4 hours for 24 hours. On day 2,~     the sodium nitrite infusion begins. Blood pressure and methemoglobin are monitored every 10~     minutes for the first 2 hours. If blood pressure remains stable, the frequency of~     measurements is decreased to every 30 minutes for 4 hours, then every 1 hour for the next 6~     hours, and then every 4 hours for 12 hours. If the pressure continues to remain stable,~     monitoring continues every 8 hours for the rest of the study. Blood is drawn periodically~     from the catheter to determine the amount of nitrite and methemoglobin in the body, with~     decreasing frequency from several times during the first hour of the infusion to every 24~     hours. After the first 24 to 48 hours of the nitrite infusion, participants are transferred~     from the ICU to a general nursing unit fo...~   "
263254|NCT00103012|"~     This study will examine the interaction of the HIV combination medication lopinavir/ritonavir~     with the herbal products echinacea, ginseng, and ginkgo biloba. Patients with HIV infection~     often take herbal products and dietary supplements in addition to their doctor-prescribed~     medicines to treat the disease, lessen the side effects of anti-viral drugs, and improve~     their overall well being. Alternative medicines such as these may, however, interfere with~     the elimination of lopinavir/ritonavir from the body, causing either higher or lower blood~     levels of these drugs than would be expected. This study will assess in healthy subjects any~     potential harms of taking echinacea, ginseng, or ginkgo biloba together with~     lopinavir/ritonavir.~      Healthy normal volunteers between 18 and 50 years of age may be eligible for this study.~     Candidates are screened with a history, physical examination, and blood tests, including an~     HIV test and a pregnancy test for women. Pregnant women are excluded from the study.~     Participants come to the NIH Clinical Center after fasting overnight for the following~     procedures:~      Visits 1 and 2: A catheter (plastic tube) is placed in an arm vein to collect blood samples.~     After the first sample is drawn, the subject takes 8 mg of midazolam syrup and two~     fexofenadine tablets. Midazolam is a sedative, and fexofenadine (Allegra) is a medicine used~     to treat allergies. Subjects are given breakfast an hour after taking the drugs. Blood~     samples are collected at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 24 hours after taking~     the drugs to measure blood levels of fexofenadine. An extra sample is collected at the 4-hour~     mark to measure the midazolam level. The catheter is removed after the 8-hour blood draw and~     subjects are dismissed home. They return the following morning (visit 2) for the 24-hour~     blood draw.~      Visit 3: From 7 to 28 days after visit 1, subjects begin taking lopinavir/ritonavir capsules~     twice a day by mouth for a total of 29.5 days. On day 15 they return to the clinic for~     lopinavir/ritonavir blood levels as were done for fexofenadine, except that samples are~     collected once before breakfast and then at 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after the~     lopinavir/ritonavir dose. An extra sample is collected for routine tests. The catheter is~     removed after the 12-hour draw and the subject is dismissed home.~      The next morning, subjects begin taking one of the following: echinacea 500 mg 3 times a day;~     ginkgo biloba 120 mg twice a day; or ginseng 500 mg 3 times a day for 28 days.~      Visit 4: On the last day of taking lopinavir/ritonavir, subjects return to the clinic again~     for blood level measurements of these drugs as on visit 3, except that the catheter is~     removed and the subject dismissed home after the 8-hour blood draw.~      Visits 5 and 6: On the last day of taking the herbal supplement, subjects return to the~     clinic for repeat measurement of fexofenadine and midazolam levels, as described in visits 1~     and 2. At the final visit (visit 6) an additional blood sample is collected for repeat~     laboratory testing.~   "
263255|NCT00102999|"~     Objectives~      The main objectives of this proposal are (1) to characterize motor learning abnormalities in~     patients with focal dystonia; (2) to show, using transcranial magnetic stimulation, that this~     abnormal motor learning went together with an impaired modulation by somatosensory inputs of~     short and long-interval paired-pulse inhibitions (sICI, lICI) and facilitations (sICF, ICF)~     of MEPs (ICIs and ICFs are thought to reflect activity of inhibitory and excitatory~     interneuron's in the primary motor cortex M1); (3) to show that abnormalities of long-term~     potentiation and long-term depression (LTP/LTD)-like mechanisms (tested using a paired~     associative stimulation (PAS) intervention), thought to play a crucial role in learning, are~     associated in dystonia with an abnormal modulation of ICIs and ICFs by somatosensory inputs.~      Study population~      30 patients with a focal upper limb dystonia and 45 healthy volunteers will take part in the~     main study. 7 patients with a focal upper limb dystonia and 12 healthy volunteers will take~     part in the control study.~      Design~      In the main study: subjects will complete 5 different sessions: visit 1: clinical screening,~     1 hour; visit PAS session, 3 hours; visit 3: a minimum of 7 days later, motor learning~     session, 3 hours; visit 4: follow-up 24 hours later, 1 hour and a half; visit 5, follow-up 48~     hours later, 1 hour and a half. During the PAS session they will receive 15 minutes of~     repeated paired stimulations (transcranial magnetic stimulation -TMS- and peripheral~     stimulation) thought to produce LTP/LTD like phenomena in M1. During the motor learning~     sessions they will be asked to perform, as fast as possible, a metronome-paced (0.5 Hz) pinch~     of their index finger and thumb. They will have 3 blocks of motor practice during the motor~     learning session.~      Between each block of motor practice and before and after PAS, while they rest, subjects will~     receive paired-pulse transcranial magnetic stimulations (TMS) associated or not with~     peripheral nerve stimulation in order to assess interactions at M1 cortical level between~     somatosensory incoming volleys and intracortical inhibitory and excitatory interneuron's.~      In the control study: subjects will complete a unique session. They will receive a PAS~     intervention. Before and after the PAS intervention, spinal excitability will be tested by~     the means of H reflexes evoked in wrist flexor muscles.~      Outcome measures:~      The behavioral effect of the motor training or of the PAS intervention will be assessed by~     measuring the mean peak acceleration (MPA) of thumb movement during the blocks of motor~     practice and the mean maximal peak force (MPF) between the index finger and thumb before and~     after the blocks of motor practice.~      The activity of different sets of intracortical interneurons (short and long interval GABA~     related inhibitions: sICI, lICI, intracortical glutamate-related facilitation: ICF and short~     interval facilitation: sICF) can be tested using paired-pulse TMS paradigms. The effect of~     learning (or of PAS intervention) on the interaction between somatosensory afferent input and~     intracortical processes will be assessed by comparing the amount of sICI, lICI, ICF and sICF~     when associated or not with a peripheral nerve stimulation (median and ulnar nerve~     stimulation) in a trained muscle (flexor pollicis brevis: FPB) and a non-trained muscle~     (abductor digiti minimi: ADM) at different times during and after the motor learning or the~     PAS intervention.~      The effect of PAS on spinal cord excitability will be assessed by comparing the size of the H~     reflex before and after PAS.~   "
263256|NCT00102986|"~     Men's and women's bodies may process anti-HIV drugs differently. The purpose of this study is~     to determine the differences in blood levels of soft gel capsules and tablets of~     lopinavir/ritonavir (LPV/r) in HIV infected men and women.~   "
273061|NCT00015171|"~     The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid~     dependence.~   "
263259|NCT00102947|"~     This is a Phase 4, randomized, open-label, multicenter, comparative study designed to further~     evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of~     daptomycin relative to comparator in the treatment of complicated skin and skin structure~     infections in patients with renal impairment.~   "
263260|NCT00102934|"~     Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most~     patients do well if they continue taking them. The purpose of this study is to test the~     effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection~     in adults who have virus resistant to multiple drugs.~   "
263261|NCT00102921|"~     The purpose of this research study is to investigate the effects of an investigational~     medication, called CCX282-B, on safety and on the some of the symptoms of Crohn’s Disease in~     patients who are experiencing an active flare-up of moderate to severe Crohn’s Disease.~   "
263262|NCT00102908|"~     Bisphosphonates are a type of drug used to prevent and treat bone loss. The purpose of this~     study is to determine if zoledronate, an investigational bisphosphonate, can improve bone~     mineral density (BMD) in HIV-infected adults.~      Study hypothesis: Zoledronate will reduce bone resorption in HIV-infected persons with~     osteopenia.~   "
263263|NCT00102895|"~     The main purpose of this research study is to see if the study drug, named CP-724,714, can~     help in the treatment of certain breast cancers that have spread to other locations in the~     body. Other goals of this study are to measure how long it may take for the cancer to get~     worse (progress), to see if there are any side effects from the study drug, to check the~     amount of study drug in the blood at different times, and to check to see if there is any~     relationship between certain blood tests and how patients may respond to the study drug.~      About 25 subjects at 4 sites (hospitals and clinics) in Bulgaria and Russia will be involved~     in the trial. Participation in this study can last up to 48 weeks, depending on the~     participant's toleration of the study drug and the response of her tumor(s) to the study~     drug. All participants will receive CP-724,714, at a daily dose of 250 mg (4 pills) every 12~     hours.~   "
263264|NCT00102882|"~     This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood~     sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done~     during the study. Study medicines and procedures will be provided at no cost. Patients will~     be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR~     and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and~     older.~   "
263265|NCT00102869|"~     The purpose of this study is to determine whether levodopa, in combination with a high~     frequency language training, is effective in boosting naming performance in patients with~     aphasia.~   "
263266|NCT00102856|"~     The purpose of this study is to determine whether rivastigmine or pramipexol are effective in~     boosting semantic language acquisition in healthy subjects.~   "
263267|NCT00102843|"~     The purpose of this study is to determine whether lowering of fasting homocysteine~     concentrations improves vascular function in healthy volunteers, irrespective of the~     homocysteine-lowering agent.~   "
263268|NCT00102830|"~     The purpose of this study is to test the safety, tolerability and pharmacokinetic (PK)~     profile of AMG 386 after intravenous administration in adult subjects with advanced solid~     tumors.~   "
263269|NCT00102817|"~     This trial is conducted in the United States of America (USA). This is a 12 month study to~     determine if Norditropin is safe and effective in children with IGF deficiency.~   "
263270|NCT00102804|"~     This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best~     supportive care versus placebo plus best supportive care in NSCLC. Participants must have~     received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to~     randomization (enrollment) into this trial.~   "
263271|NCT00102791|"~     The purpose of this study is to compare the effects of ICA-17043 to placebo with or without~     hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle~     cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to~     a medical facility within the past 12 months.~   "
263272|NCT00102778|"~     This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in~     combination with Kaletra in HIV infected, untreated subjects.~   "
263273|NCT00102765|"~     This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic~     visits will include physical examination, medical history review and lung function tests. The~     purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is~     better in reducing the number of asthma exacerbations compared with another drug (fluticasone~     propionate alone)~   "
263274|NCT00102752|"~     The purpose of this study is to determine the safety of glufosfamide when administered in~     combination with gemcitabine.~   "
263275|NCT00102739|"~     This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose,~     study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of~     SB-497115-GR as a treatment for patients with ITP who have failed prior therapy. The study is~     designed to determine the proportion of patients with a platelet count =50,000/µL after 42~     days. In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in~     a 2:1 ratio of active:placebo. During the 6 week study period, subjects will start on placebo~     or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count~     at day 22.~   "
263276|NCT00102726|"~     SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet~     counts in healthy volunteers. This study is examining several different doses of SB497115~     versus placebo as treatment for patients with advanced solid tumors scheduled to receive~     chemotherapy with carboplatin and paclitaxel every 21 days. Patients will receive SB497115 on~     days 2-11 of each 21 day cycle for at least 2 cycles of chemotherapy and for a maximum of 8~     cycles of chemotherapy.~   "
263277|NCT00102713|"~     The purpose of the study is to assess the safety profile of the investigational medication,~     Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.~   "
263278|NCT00102700|"~     The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine~     in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.~   "
264707|NCT00087828|"~     The purpose of this study is to identify the substances in cranberry juice that make it~     effective in reducing urinary tract infections (UTIs) in women.~   "
263281|NCT00102661|"~     The goal of this clinical research study is to learn if giving CAMPATH-1H first as an~     injection into a vein, then as an injection under the skin can shrink or slow the growth of~     the disease in patients with chronic lymphocytic leukemia (CLL) who have already received~     standard therapy. Another goal is to learn if the side effects related to CAMPATH-1H~     treatment are less severe by giving the drug first as an injection into a vein then as an~     injection under the skin.~   "
263282|NCT00102648|"~     The goal of this clinical research study is to find the highest safe dose of the new drug~     Sarasar (lonafarnib) that can be given together with Temodar (temozolomide) in a continuous~     daily dosing regimen to patients with brain tumors. The second goal is to learn if these~     drugs given in combination can shrink or slow the growth of brain tumors.~      This is an investigational study. Temozolomide is approved by the FDA for the treatment of~     some brain tumors. Lonafarnib is approved for research use only in the treatment of brain~     tumors. The use of these two drugs together is experimental.~      About 35 patients will take part in this study. All will be enrolled at MD Anderson.~   "
263283|NCT00102635|"~     The primary objective of this study is to estimate the modulation of intermediate biological~     endpoints of the combination of 4-HPR and SCH66336, a farnesyl transferase inhibitor (FTI),~     across 4 randomly assigned dose levels in patients with locally advanced or recurrent head~     and neck cancer. We will also assess the activity, safety, tolerability and side effects of~     4-HPR/SCH66336 and hope to establish a phase II regimen.~   "
263284|NCT00102622|"~     The goal of this clinical research study is to find the highest safe dose of intraperitoneal~     tgDCC-E1A that can be given in combination with paclitaxel as a treatment for patients with~     recurrent, platinum-resistant ovarian cancer. How the cancer responds to this treatment will~     also be studied. Researchers will also ask the patients if they will allow additional tumor~     samples to be collected and extra blood samples to be drawn. These samples will be used to~     learn about the biological response before and after treatment.~   "
263285|NCT00102609|"~     The purpose of the study is to determine the dose of the combination of trabectedin~     (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be~     managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control~     neutropenia) in patients with a type of cancer called soft tissue sarcoma.~   "
263286|NCT00102596|"~     OVERVIEW~      Essential tremor (ET) is a common movement disorder affecting 0.4% of the general population~     and up to 14% of people 65 years and older. Response to medications such as beta blockers and~     primidone may be of benefit, but are often accompanied by intolerable side effects. Response~     to ethanol, on the other hand, has a roughly 80% chance of significant tremor reduction,~     though daily use of this as a treatment has potentially serious medical, social, and legal~     consequences.~      The leading hypothesis for ET pathophysiology is an unmasking of spontaneous oscillations~     originating in neurons of the inferior olive. Both ethanol and 1-octanol have been shown to~     reduce these spontaneous oscillations in an animal model of ET; however, 1-octanol does this~     at a dose much lower than that leading to intoxication, suggesting in may be useful in the~     treatment of essential tremor. Our initial studies with 1-octanol have shown it to be safe at~     dosages up to 64mg/kg without signs of intoxication, while at the same time showing benefit.~      OBJECTIVE~      We plan to evaluate the efficacy of different 1-octanol formulations in humans based on~     accelerometry and spirography. We will also evaluate drug and metabolite bioavailabilities~     using a high performance liquid chromatography (HPLC) detection method from plasma and urine~     samples.~      STUDY POPULATION~      We will study adult subjects with ethanol-responsive Essential Tremor (ET).~      DESIGN~      This study is designed as a two-phase unblinded inpatient study of adults with ET receiving~     weight-adjusted oral dosages of 2 different formulations of 1-octanol in a crossover fashion.~     Phase I of the study is designed to develop an octanol detection assay using HPLC. Four~     subjects will receive daily escalating dosages (1-32 mg/kg) of a single 1-octanol formulation~     followed by a crossover trial of both formulations at a dosage of 64 mg/kg. Phase II will~     study 20 subjects receiving one of the two formulations at 64 mg/kg on inpatient day 1~     followed by a 24 hour period of close monitoring. The second formulation will be given on day~     3 and the patient will again undergo close monitoring for 24 hours.~      OUTCOME MEASURES~      The primary outcome measures for the study will be efficacy based on tremor ratings from~     accelerometry and spirography. Secondary outcome measures will be the determination of~     bioavailability, pharmacodynamic and pharmacokinetic profiles of octanol #61864 and octanol~     #68751 and their metabolites.~   "
263287|NCT00102583|"~     Graft-vs.-Host Disease (GVHD) is a major complication of allogeneic hematopoietic stem cell~     transplantation (SCT) commonly affecting the skin, liver, gastrointestinal tract, and eye.~     The most common clinical manifestations of ocular GVHD generally result from~      involvement of the lacrimal gland and the conjunctiva. Lacrimal gland involvement can lead to~     aqueous tear deficiency resulting in severe keratoconjunctivitis sicca (KCS) which can~     significantly increase the morbidity of patients with chronic GVHD.~      Systemic immunosuppressants such as cyclosporine (CsA) can be effective for treating ocular~     GVHD including lacrimal gland dysfunction. However, systemic immunosuppression is not~     generally prescribed for patients whose sole manifestation of GVHD is ocular complications as~     it may negate the overall graft-vs.-tumor effect and decrease patient survival. Topical CsA~     and corticosteroids are generally not effective for treating aqueous tear deficiency possible~     due to epithelial barriers preventing penetration of the drugs to the lacrimal gland. A~     sustained-release subconjunctival CsA implant was developed to bypass these epithelial~     barriers and significantly increase the CsA concentrations in the lacrimal gland to treat~     aqueous tear deficiency related to GVHD.~      The objective of this randomized pilot study is to investigate the safety and potential~     efficacy of a CsA implant in patients with lacrimal gland involvement and aqueous tear~     deficiency related to GVHD. Safety will be evaluated in terms of adverse events related to~     the implant. Efficacy will be evaluated by changes in Schirmer tear test (with anesthesia).~     Secondary efficacy evaluation will include changes in corneal and conjunctival staining~     grades, best-corrected visual acuity (BCVA), the Ocular Surface Disease Index (OSDI), changes~     in conjunctival GVHD grades, tear break-up time and meibomian gland dysfunction.~      Patients with active systemic GVHD with aqueous tear deficiency associated with lacrimal~     gland dysfunction following allogeneic hematopoietic SCT who are nine years of age or older~     are eligible for inclusion in this pilot study. The study will involve surgical placement of~     the CsA implant into the subconjunctival space adjacent to the lacrimal gland of one eye in~     each participant. Participants older than 12 years of age will be randomized to receive one~     of two implant release rates. All participants under the age of 12 will receive the smaller,~     lower dose implant. However, all participants under age 12 will not be randomized and will~     only be eligible to receive the smaller, lower dose implant.~      The implant will remain in place for up to two years and then be removed. IF the participant~     has clinical success, they will be given the option of allowing the implant to remain in~     place for an additional year. Clinical success is achieved if the participant meets any of~     the following measures in either eye assessed at the 1-year visit:~      Interval change from baseline characteristics~      Decrease in corneal staining by greater than or equal to 2~      Decrease in temporal or nasal conjunctival staining grades by greater than or equal to 2~      Decrease in total staining grade by greater than or equal to 2~      Decrease in OSDI calculated score by greater than or equal to 20%~      Increase in Schirmer tear test measurement by greater than or equal to 3 mm~      Meets mild-moderate KCS characteristics at 1 year~      Corneal staining grade less than or equal to 3~      Nasal or temporal conjunctival staining grades less than or equal to 3~      OSDI calculated score less than or equal to 15~      Schirmer tear test measurement greater than or equal to 5 mm~      For participants with implant duration of one year, safety evaluations will be conducted at~     baseline (pre-implantation) and monthly post-implantation for 13 months. Additional safety~     assessments will be done at 1 day, and at 1 and 2 weeks post-operatively for implant~     placement and removal procedures. Safety and efficacy evaluations will be conducted at~     baseline, at 1, 3, 6, 9, and 12 months post-implantation, and at 3 months following implant~     removal (15 months post-implantation). For participants with clinical success and who choose~     the implant to remain for another year, visits will be held as described above then conducted~     at 2-month intervals starting at month 14. Safety evaluations will be conducted every 2~     months until the end of the second year. Additional safety assessments will be done at 1 day,~     and at 1 and 2 weeks post-operatively for implant removal procedures. Safety and efficacy~     evaluations will be conducted at 16, 20, and 24 months post-implantation, and at 3 months~     following implant removal (27 months post-implantation).~   "
263288|NCT00102570|"~     This study will evaluate children with allergies and collect medical data and biological~     specimens from them periodically to learn more about the diseases and gain information that~     may be useful in developing new treatments.~      Patients 6 months to 18 years of age with a possible diagnosis of asthma, rhinitis,~     anaphylaxis, hives, atopic dermatitis, food allergy, stinging insect allergy, and other~     allergic and inflammatory diseases may be eligible for this study. Biological parents of~     patients may also be enrolled to provide a blood sample for genetic studies.~      Participants undergo tests appropriate for the diagnosis and management of their allergy.~     They include the tests outlined below and, when necessary, additional blood tests, tissue~     biopsies (surgical removal of a small piece of tissue for microscopic examination), computed~     tomography (CT) or magnetic resonance imaging (MRI).~        -  Pulmonary function test: This test evaluates lung function. The patient blows hard into~          a tube attached to a machine to measure the airflow from the lungs. At home, the patient~          uses a small plastic device called a peak flow meter to measure lung function. Patients~          whose lung function measures less than 80 percent the value predicted for his or her age~          may be given the medicine albuterol to see if lung function improves.~        -  Skin prick testing: Drops of up to 55 different allergens (foreign substances, such as~          pollen and certain foods or medicines that cause reactions like sneezing, hives, eczema,~          and others) are placed on the back or arm. The skin under the allergen is then scratched~          with a pointed tool. If the person is allergic, the skin around the scratch develops a~          small area of itching, redness, or swelling that goes away after 30 to 60 minutes.~        -  Acoustic rhinometry: To learn the effect of allergies on the size of the nasal cavity,~          the nasal canal size is measured by placing a small round probe on the nostril. The~          device sends out and receives a sound wave signal from which the size of the nasal canal~          is calculated, recorded and stored graphically on a computer screen. The procedure is~          repeated three times with each nostril.~        -  Computerized assessment of learning and mood: Patients who are age 10 or older may take~          this computer test to find out if allergies affect learning and mood. The test measures~          the child's ability to understand directions, solve problems, and remember things. It~          also includes questions about how the child feels in general.~        -  Behavioral assessment system for children: Patients who are age 8 or older may take this~          true/false questionnaire to assess mood.~        -  Blood may be drawn for the following purposes: in lieu of skin prick testing to~          determine sensitivity to allergens; to look for reasons for the severity or cause of an~          allergy; for research studies on the immune system, including markers of allergy; for~          genetic tests to determine inherited factors that increase the risk of developing~          allergies.~      Patients are scheduled for follow-up visits based on their diagnosis and severity of illness.~     Most patients return for within one month of their first study visit and then, in general,~     once a month when allergies are severe, and every few months when they are more stable.~     Visits include an updated history and physical examination, blood tests, and possibly some of~     the tests described above. Patients may also have intradermal skin testing, in which~     allergens that are used for skin prick testing are injected into the forearms or upper arms~     just below the surface of the skin.~      Patients who test positive to allergens may be offered standard treatment with allergy shots.~   "
263289|NCT00102557|"~     This study will compare two treatments for oral lichen planus - hydroxychloroquine~     (Plaquenil) tablets and clobetasol oral rinse. Oral lichen planus is a chronic disorder in~     which patients have painful mouth ulcers that interfere with meals and daily functioning. It~     is most commonly treated with topical or systemic corticosteroids, but these drugs have a~     number of side effects, most commonly yeast infection, and chronic systemic use of them can~     lead to diabetes, osteoporosis, weight gain, and other complications. Also, lichen planus~     generally returns when the corticosteroids are stopped. Clobetasol oral rinse is a topical~     steroid commonly used to treat oral lichen planus. Hydroxychloroquine, a drug that was~     originally used to treat malaria and is now also approved for lupus and rheumatoid arthritis,~     has been tried for lichen planus in small-scale studies with some evidence of benefit.~      Patients 18 years of age and older with oral lichen planus may be eligible for this study.~     Pregnant women are excluded. Candidates are screened with a dermatology examination, routine~     blood tests, an eye examination, and a biopsy to rule out other conditions similar to lichen~     planus and to provide tissue for research purposes. For the biopsy, two small circles of~     tissue about 4 mm (less than 1/5) across are surgically removed from the area with lichen~     planus.~      Participants are randomly assigned to treatment with either hydroxychloroquine or clobetasol~     rinse. Patients assigned to hydroxychloroquine also take a placebo mouth rinse that looks and~     tastes like the clobetasol rinse, and those assigned to clobetasol also take a pill that~     looks and tastes like the hydroxychloroquine tablet. This is done so that neither the~     patients nor the study doctors know which patient is taking which active medication until the~     study is completed. Patients take the pills daily in the morning with food or a glass of milk~     for the 6-month study period and use the rinse twice a day for 4 months and then once a day~     for 2 months. They may not use any pain or anti-inflammatory medicines or topical creams,~     gels or rinses regularly, because these medications can obscure the effects of the study~     drugs and complicate interpretation of the results. They are given a topical numbing medicine~     as part of the study and can use Tylenol for pain during the study duration.~      In addition to treatment, participants visit the NIH Clinical Center once a month for the~     following tests and procedures:~        -  Review of pain levels, as recorded in a pain diary~        -  Review of drug side effects, if any~        -  Collection of saliva and blood samples at 2, 4 and 6 months~        -  Repeat oral biopsy at completion of the study at 6 months to evaluate treatment effects~        -  Final examination at 8 months to determine if the disease returns or improves after the~          medication is stopped.~   "
263306|NCT00102336|"~     The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of~     thrombocytopenia in subjects with ITP as measured by the platelet response. This study will~     also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to~     treatment with AMG 531.~   "
263307|NCT00102323|"~     The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of~     thrombocytopenia in subjects with ITP as measured by the platelet response. This study will~     also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to~     treatment with AMG 531.~   "
263308|NCT00102310|"~     The primary objective of this study will be to characterize the dose response profile of~     YM443 in subjects with functional dyspepsia (FD) to enable the selection of doses for the~     Phase 3 clinical trial.~   "
263321|NCT00102141|"~     The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8~     weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the~     relief of vasomotor symptoms and who have hypertension.~   "
263290|NCT00102544|"~     This study will evaluate the accuracy and effectiveness of an experimental tracking device~     for locating abnormalities during invasive procedures, such as biopsy or ablation, that~     cannot easily be visualized by usual imaging techniques, such as computed tomography (CT)~     scans or ultrasound. Some lesions, such as certain liver or kidney tumors, small endocrine~     abnormalities, and others, may be hard to find or only visible for a few seconds. The new~     method uses a needle with a miniature tracking device buried inside the metal that tells~     where the tip of the needle is located, somewhat like a mini GPS, or global positioning~     system. It uses a very weak magnet to localize the device like a miniature satellite system.~     This study will explore whether this system can be used in the future to more accurately~     place the needle in or near the desired location or abnormality.~      Patients 18 years of age and older who have a lesion that needs to be biopsied or an ablation~     procedure that requires CT guidance may be eligible for this study. Candidates are screened~     with a medical history and review of medical records, including imaging studies.~      Participants undergo the biopsy or ablation procedure as they normally would, with the~     following exceptions: some stickers are placed on the skin before the procedure and a very~     weak magnet is placed nearby. The needles used are similar to the ones that would normally be~     used except that they contain a metal coil or spring buried deep within the needle metal. The~     procedure involves the following steps:~        1. Small 1-cm plastic donuts are place on the skin with tape.~        2. A planning CT scan is done.~        3. The CT scan is sent to the computer and matched to the patient's body location with the~          help of a very weak magnet.~        4. The needle used for the procedure is placed towards the target tissue or abnormality and~          the smart needle location lights up on the old CT scan.~        5. A repeat CT is done as it normally is to look for the location of the needle.~        6. After the procedure the CT scans are examined to determine how well the new tool located~          the needle in the old scan.~   "
263291|NCT00102531|"~     Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated~     dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients~     with relapsed/progressive osteosarcoma metastatic to the lung.~   "
263292|NCT00102518|"~     The purpose of this study is to test the long-term safety and tolerability of aripiprazole in~     adolescent patients with schizophrenia, and child and adolescent patients with bipolar I~     disorder, manic or mixed episode.~   "
263293|NCT00102505|"~     The purpose of the study is to determine the dose limiting toxicities and maximum tolerated~     dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with~     Non-small Cell Lung Cancer.~      A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin~     treatment followed by 2 weeks without treatment.~      Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of~     docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor~     response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may~     stay on the study a maximum of 6 cycles.~   "
263294|NCT00102492|"~     This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of~     GW679769 in subjects with major depressive disorder.~   "
263295|NCT00102479|"~     The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of~     aripiprazole tablets following oral administration to children and adolescents.~   "
263296|NCT00102466|"~     This study is not being conducted in the United States. Many people with type 2 diabetes~     cannot maintain target blood glucose levels when taking a single oral drug. The purpose of~     this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug,~     compared to that of gliclazide in lowering overall blood glucose levels when added to~     metformin in people with type 2 diabetes not at target blood glucose levels on metformin~     alone.~   "
263297|NCT00102453|"~     In this study, the primary aim will be to estimate the magnitude and variability of strength~     change over time that may be expected for subjects on the study treatment. This estimate of~     effect will allow us to develop a rigorous statistical plan in the future randomized study.~     The specific estimation technique to be applied will use a linear random effects model to~     estimate average strength change during the 3-month lead-in period and then during the~     twelve-month treatment period, taking into account the quantitative muscle testing (QMT)~     measures for each subject. Accounting for the correlation between repeated measures from each~     subject by using a random effects model will yield an unbiased estimate of variability for~     the population average change in strength. We will use an analysis of pre- and post-treatment~     data to inform a best estimate of treatment effect. For example, the difference in QMT trends~     pre- and post-treatment would provide a straightforward measure of efficacy.~   "
263298|NCT00102440|"~     The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily~     (QD), versus allopurinol in subjects with gout.~   "
263299|NCT00102427|"~     The purpose of this study is to determine if primary care patients with panic and/or~     generalized anxiety disorder can benefit from a telephone-based collaborative care~     intervention.~   "
263300|NCT00102414|"~     The primary objective of this study is to compare the time to progressive disease in patients~     treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have~     advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy 6~     months after treatment discontinuation.~   "
263301|NCT00102401|"~     The overall goal of this study is to compare the impact of a new Internet Dyspnea~     Self-Management Program (eDSMP) with an established face-to-face Dyspnea Self-Management~     Program (DSMP) in patients with COPD. The primary aim of the study is to test the following~     two hypotheses: 1. The eDSMP and the DSMP will have comparable improvements in the primary~     outcomes of shortness of breath (dyspnea) with activities of daily living (ADL), exercise~     adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6~     months. 2. The eDSMP and the DSMP will have comparable improvements in the secondary outcomes~     of perception of support, self-efficacy for exercise and managing dyspnea, and health~     resource utilization at 3 and 6 months. This study is a randomized, longitudinal, repeated~     measures design with measurement times at 0, 3, and 6 months.~   "
263302|NCT00102388|"~     This study is not being conducted in the United States. The purpose of this study is to~     assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to~     gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have~     not been previously treated with drug therapy to lower their blood sugar.~   "
263303|NCT00102375|"~     The purpose of this study is to determine whether the triple combination of Carboplatin,~     Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer~     compared with the combination of Carboplatin and Paclitaxel.~   "
263304|NCT00102362|"~     The purpose of this study is to examine the effectiveness of a 12-hour basic job-training~     program designed to give drug abuse treatment patients the skills they need to find and~     secure a job and set vocational goals and methods for locating employment. The intervention~     to be evaluated is modeled after the Job Seekers' Workshop, which was manualized and has been~     tested in trials.~   "
263309|NCT00102297|"~     The Phase 1b study is a multi-center trial designed to test the safety, tolerability,~     biologic activity of escalating doses of FG-3019 in up to 20 patients with type 1 or type 2~     diabetes and microalbuminuria (early-stage kidney disease). Patients will receive either 3 or~     10 mg/kg of FG-3019 administered every two weeks as an infusion for a total of four doses.~     The ability of FG-3019 to reduce the excretion of protein in the urine is being measured as a~     secondary endpoint.~   "
263310|NCT00102284|"~     The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or~     modafinil are effective in boosting semantic language acquisition in healthy subjects.~   "
263311|NCT00102271|"~     This study will examine 1) how nitrite (a natural blood substance that relaxes blood vessels)~     increases blood flow and lowers blood pressure, and 2) how to increase the effects of nitrite~     on blood pressure.~      Healthy volunteers between 21 and 40 years of age may be eligible for this study. They must~     be non-smokers and have no history of high blood pressure, high cholesterol, or diabetes.~     Candidates are screened with a medical history, physical examination, electrocardiogram, and~     blood tests. This study is either done in the NIH Clinical Center intensive care unit or on~     the general clinical ward. Participants are enrolled in Part A of the study. After completion~     of Part A participants will be enrolled in Part B of the study.~      Part A:~      Participants lie in a reclining chair during the study. Small catheters (plastic tubes) are~     inserted into an artery and vein in the forearm. Another tube is placed in the vein of the~     opposite arm. Blood pressure cuffs are placed around the upper arm and wrist, and a strain~     gauge (a rubber band-like device) is placed around the forearm. This device helps us to~     measure blood flow through the arm. When the blood pressure cuffs are inflated, blood flows~     into the forearm, stretching the strain gauge at a rate proportional to the blood flow.~     Pressure cuffs and a strain gauge are also placed on the other arm. After 20 minutes, blood~     pressure and blood flow are measured in both forearms. Then blood is drawn from the tube in~     the right vein to measure blood counts, proteins, and other chemicals. Participants then are~     given small doses of either saline, ascorbic acid, or a medicine called oxypurinol, a form of~     a drug that is often taken to prevent gout. After 30 minutes, sodium nitrite is injected in~     increasing doses into the artery for 30 minutes. Blood flow is measured and blood is drawn~     every 5 minutes during the infusion. At the end of the 30 minutes, blood is drawn from the~     vein every 30 minutes for 3 hours. After 3 hours, sodium nitrite infusions are restarted for~     2 hours and blood flow is measured and samples collected every 30 minutes during this period.~      Part B: Participants lie in a reclining chair during the study. A small catheter (plastic~     tube) is placed in the artery of the left forearm to draw blood samples. A larger catheter~     called a central line is placed in a deeper vein in the neck. Another tube is advanced~     through the central line into the chambers of the heart, through the heart valve, and into~     the lung artery to measure pressures in the heart and lungs. Blood is drawn after 30 minutes~     to obtain baseline measurements. Then saline (sterile salt water) is put into the tube in the~     lung artery. Blood pressure cuffs are placed around the upper arm and wrist, and a strain~     gauge (a rubber band-like device) is placed around the forearm, which helps us to measure~     flow through the arm. When the cuffs are inflated, blood flows into the forearm, stretching~     the strain gauge at a rate proportional to the blood flow. Pressure cuffs and a strain gauge~     are also placed on the other arm. After 20 minutes, blood pressure and blood flow are~     measured in the forearm and blood samples are drawn from the tube in the left artery to~     measure blood counts, proteins, and other chemicals.~      Subjects then breathe a mixture of oxygen and nitrogen through a facemask for 30 minutes,~     then room air for 30 minutes, and then the oxygen and nitrogen mixture for another 30~     minutes. While breathing the mixture the second time, sodium nitrite is injected through the~     tube in the artery in three increasing doses for 5 minutes each. Every 5 minutes during the~     infusion blood is drawn from the tubes in the neck. Forearm blood flow is also measured every~     5 minutes. After 30 minutes, the subject breathes room air for 3 hours and 15 minutes and~     then the sodium nitrite is injected again in three increasing doses for 5 minutes each. Every~     5 minutes during the infusion blood is taken from the tube in the neck and forearm blood flow~     is measured~   "
263312|NCT00102258|"~     This study will determine whether adding more calories to the diet helps boys with growth~     problems grow better while being treated with Nutropin, a growth hormone that is used to help~     children grow taller. The Food and Drug Administration has approved Nutropin for use in~     children who are very short. This study will examine whether giving nutritional supplements~     in addition to Nutropin can help children grow better than with Nutropin alone.~      Boys between 7 and 10 years of age who are very short and below average in weight, but are~     otherwise healthy may be eligible for this study. Candidates must qualify for Nutropin~     treatments to boost their growth. Boys will be recruited for the study from the Nemours~     Children's Clinic in Jacksonville, FL, and from the National Institutes of Health in~     Bethesda, MD.~      Participants are randomly assigned to one of two treatment groups. One group is observed for~     6 months and then receives a Nutropin injection every day for 12 months. The second group~     drinks 8 ounces of a high-calorie beverage called Pediasure every day for 6 months and then~     receives Nutropin plus Pediasure every day for 12 months. In addition to treatment,~     participants undergo the following tests and procedures at the schedule indicated: Baseline,~     3, 6, 9, 12, 15 and 18 months~        -  Clinical examination~        -  Height measurement~        -  Body composition assessment: Skin-fold thickness calipers are used in four places on the~          body to estimate body fat~        -  Bioelectric impedance: A small amount of electrical current is used to calculate the~          percentage of body fat.~      Baseline, 6, 12, and 18 months~        -  Blood tests~        -  Bone age x-ray: x-ray of the left hand to measure growth potential~        -  DEXA (dual energy x-ray absorptiometry) scan: x-ray scan to measure body fat, muscle,~          and bone mineral content. The subject lies on a flat table during the scan.~      Baseline, 6, and 12 months~        -  Record of dietary intake: Parents are asked to write down everything the child eats and~          drinks for 3 days. Using this record, a dietitian calculates the daily caloric intake.~        -  Total energy expenditure: This test determines how much energy the child uses. For the~          test, the child drinks water labeled with harmless isotopes (heavy oxygen and heavy~          hydrogen). For the next 10 days he collects urine in plastic tubes at home. At the end~          of the 10 days, the parents bring the urine to the clinic for analysis to determine how~          fast the labeled water leaves the body. This information is used to calculate how much~          energy the child expends each day.~      Participants' weight is measured at 2 and 4 weeks, and then monthly for the remainder of the~     18-month study.~   "
263313|NCT00102245|"~     This study will examine blood for factors that may cause or prevent diseases involving iron~     or red blood cells. Iron is an important nutrient for human health that is needed to produce~     red blood cells. Red blood cells carry oxygen to body tissues. A better understanding of iron~     and red blood cells may help lead to better treatment of several diseases including anemia.~      Patients of all ages with red cell abnormalities in the following categories may be eligible~     for this study:~        -  Diseases with deficiency, overload or maldistribution of iron~        -  Known red blood cell diseases, such as anemias and hemoglobinopathies~        -  Red blood cell diseases of unknown cause, such as hemolysis of unknown cause~        -  Red blood cell abnormalities with no overt clinical disease, such as hereditary~          persistence of fetal hemoglobin~      Participants undergo the following procedures:~        -  Medical history~        -  Physical examination~        -  Standard medical tests related to the individual's iron or red blood cell condition~      Blood draw for the following purposes:~        -  Testing for syphilis and for the hepatitis B and C, HIV, and HTLV-1viruses, and for a~          pregnancy test for women who can become pregnant~        -  Research purposes. This blood is analyzed for genes, proteins, sugars, and fat~          molecules.~   "
263314|NCT00102232|"~     The purpose of this study is to determine whether supplementation with phosphatidylcholine~     lowers plasma homocysteine concentrations in healthy men.~   "
263315|NCT00102219|"~     This is a non-randomized Phase 2 study testing pemetrexed and doxorubicin in combination for~     locally advanced or metastatic breast cancer. Both pemetrexed and doxorubicin have been~     combined with other drugs, but they have not yet been combined with each other. It is~     expected that the patient will benefit from the different mechanisms of action of the two~     drugs. However, there is no guarantee that the patient will benefit from this treatment.~   "
263316|NCT00102206|"~     HIV infected children and adolescents who have taken many anti-HIV drugs may have limited~     treatment options and are at high risk for progressing to AIDS. The purpose of this study is~     to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2~     nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4~     NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV~     treatment.~   "
263317|NCT00102193|"~     The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn~     Apheresis System to treat the signs and symptoms of ulcerative colitis.~   "
263318|NCT00102180|"~     To investigate the relationship between the use of prescription drugs and the occurrence of~     ventricular arrhythmia and sudden death.~   "
263319|NCT00102167|"~     A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult~     Volunteers in a Model of Insomnia for insomnia (a sleep disorder).~   "
263324|NCT00102102|"~     This study will examine the role of substance P, a chemical messenger in the brain, in~     post-traumatic stress disorder (PTSD), a chronic anxiety disorder. PTSD can develop after~     exposure to a terrifying event or ordeal, such as a violent personal assault, natural or~     human-caused disaster, accident, or military combat. Substance P is a peptide that may be~     important in the response to certain psychiatric and neurological diseases and conditions,~     including anxiety.~      Healthy normal volunteers and people with PTSD who are between 18 and 65 years of age may be~     eligible for this study. Candidates are screened with a physical examination, blood and urine~     tests, pregnancy test for women who can become pregnant, and a neuropsychological evaluation.~      Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI)~     scanning. An optional lumbar puncture (spinal tap) is also requested.~      PET Scanning~      PET uses small amounts of a radioactive chemical called a tracer that labels active areas~     of the brain. The tracer used in this study is [18F]SPA-RQ. For the procedure, the subject~     lies still on the scanner bed. A special mask is fitted to the head to help keep the~     subject's head still during the scan so the images will be clear. A 20-minute transmission~     scan is done before the radioactive tracer is injected to provide measures of the brain that~     will help in the precise calculation of information from subsequent scans. After the tracer~     is injected through a needle in the arm, pictures are taken continuously for about 2 hours.~     Then, 20- to 40-minute images are taken every hour until about 5 hours after the injection.~      MRI Scanning~      An MRI scan is scheduled at some time within 1 year of the PET scan. MRI uses a magnetic~     field and radio waves to obtain images of body tissues and organs. The subject lies still on~     a table inside the tunnel-like MRI scanner. Earplugs are worn to muffle loud noises that~     occur during the scanning. The maximum duration of the scan is 60 minutes.~      Lumbar Puncture~      Lumbar puncture is used to examine the cerebrospinal fluid (CSF) that surrounds both the~     brain and the spinal cord. For this procedure, a local anesthetic is given to numb the skin~     in the lower back area. A small needle is then inserted into the space between the bones in~     the lower back where the CSF circulates below the spinal cord. A small amount of fluid is~     collected through the needle.~      Blood Draw~      A blood sample is collected to generate cell lines that can be used to extract DNA (genetic~     material) for gene studies and that can be frozen for future use.~   "
263325|NCT00102089|"~     This study will test the safety and side effects of an experimental vaccine booster against~     HIV. A vaccine is a substance given to try to create immunity or resistance to a disease or~     infection. The vaccine used in this study is called VRC-HIVADV014-00-VP. It is made from an~     adenovirus (a common virus that causes upper respiratory infections) that contains DNA~     (genetic material) of three HIV proteins. Injected into a human, the viral DNA instructs the~     body to make small amounts of some HIV proteins. VRC-HIVADV014-00-VP will be given to people~     who previously received a vaccine called VRC-HIVDNA009-00-VP under NIH protocol 03-I-0022.~     Important: Study participants cannot catch an adenovirus infection or HIV or AIDS from the~     vaccine or any proteins made from it.~      Healthy normal volunteers who participated in NIH protocol 03-I-0022 may be eligible for this~     study. They must have completed three injections of 4 mg or 8 mg of VRC-HIVDNA009-00-VP~     without experiencing a serious side effect that was possibly related to the vaccine.~     Candidates are screened with a medical history, clinical evaluation, blood and urine tests,~     and HIV and pregnancy counseling.~      Participants receive one injection of VRC-HIVADV014-00-VP the day they enroll in the study~     (study day 0). They are observed for at least 30 minutes after immunization. At home, they~     record their temperature and any symptoms they may experience, including any effects at the~     injection site, for 5 days and call a study nurse 1 or 2 days after the injection. They~     immediately report any symptoms to the clinic staff and, if necessary, come to the clinic for~     an examination.~      Participants have five additional clinic visits during the study, at weeks 2, 4, 6, 12 and~     24, each lasting about 2 hours. At each visit, they are checked for health changes or~     problems and are asked about medications they are taking. Blood is drawn for immune function~     testing, HLA typing (a genetic test of immune system markers), and other genetic factors. A~     urine sample is collected at some visits. Additional laboratory tests may be requested~     between visits. Some participants may undergo apheresis at the week 4 visit to collect a~     large number of white blood cells for laboratory tests to see how the immune system responds~     to the study vaccine. For this procedure, blood is collected through a needle in an arm vein~     and flows through a catheter (plastic tube) into a machine that separates it into its~     components by centrifugation (spinning). The white cells are extracted and the rest of the~     blood is returned through another needle in the other arm. The procedure takes about 1 to 3~     hours.~      Participants are tested three or more times for HIV and are questioned about their sexual~     behavior and drug use. They complete a social impact questionnaire at week 24 that includes~     questions about any problems they may have experienced from their participation in the study~     regarding such things as insurance, health care, friends, family, employment, housing,~     education, or government agencies.~   "
263326|NCT00102076|"~     One of the principal safeguards mandated by the Federal Regulations governing clinical~     research with children is the assent requirement: children who are capable must provide an~     affirmative agreement to participate unless the research holds out a prospect of direct~     benefit that is important to the health or well-being of the children and is available only~     in the context of the research (46.408). Despite the importance of the assent requirement,~     the Federal regulations offer no guidelines on its implementation. In the present study, we~     propose to survey children and one of their parents in order to obtain information concerning~     children's role in making decisions concerning their participation in clinical research. Five~     elements of children's involvement in the decision-making process with respect to their~     participation in clinical research will be assessed: 1) receipt of information concerning the~     available options; 2) understanding of this information; 3) assessment of the available~     options; 4) expression of a preferred option; and 5) coordination with parental~     decision-making.~      Three groups will be enrolled: 1. Minor/Parent pairs where the minor is participating in, or~     is in follow-up for, a drug treatment research study for cancer 2. Minor/Parent pairs where~     the minor is participating in, or is in follow-up for, a drug treatment research study for~     asthma, and 3. Minor/Parent pairs where the minor is receiving on-going clinical care for~     asthma. Children 7-14 years of age will be enrolled. Total enrollment will be 400 subject~     pairs, approximately 150 in cancer research, 150 in asthma research and 100 involved in~     clinical care for asthma, with approximate balance between the sites. Two formalized survey~     instruments - research/clinical minor, research/clinical parent - will be developed in~     consultation with Research Triangle Institute (RTI).~   "
263327|NCT00102063|"~     The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent~     patients with schizophrenia for a period of at least 6 weeks.~   "
263328|NCT00102050|"~     NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a~     primary early stage indication of peripheral arterial disease (PAD). This trial is designed~     to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 taken twice a day (BID) for 24~     weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of~     Intermittent Claudication.~   "
263329|NCT00102037|"~     This trial is conducted in the United States of America (USA). The purpose of this clinical~     research trial is to understand how safe and effective Recombinant Activated FVII is for~     reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.~   "
263330|NCT00102024|"~     This is a Phase I/II open-label, dose-escalating study in patients with metastatic colorectal~     cancer. The objectives of the study are to obtain information on the safety of radiolabeled~     IDEC-159, as well as its activity in colorectal cancer. Another objective is to determine the~     maximum tolerated dose (MTD). The study duration is 2 years with visits occuring daily and/or~     weekly for the first 3 months, and every 6 weeks until the end of the 2 year period.~   "
263331|NCT00102011|"~     RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors~     find tumor cells early and plan better treatment for colorectal cancer.~      PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works~     compared to fecal occult blood test in screening healthy participants for colorectal cancer.~   "
263332|NCT00101998|"~     A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of~     an investigational drug for the treatment of constipation due to prescription pain medication~     in subjects with cancer pain. The study will require five visits over a five-week period.~   "
263333|NCT00101985|"~     This study will evaluate the effectiveness and safety of the investigational drug talnetant~     in treating subjects with irritable bowel syndrome (IBS).~   "
263334|NCT00101972|"~     RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them.~      PURPOSE: This phase I trial is studying the side effects and best dose of RAV12 in treating~     patients with metastatic or recurrent adenocarcinoma.~   "
263335|NCT00101959|"~     Brief Summary: 800 RRMS Subjects currently treated with Avonex or Copaxone will be randomized~     to either continue on their current therapy or receive Rebif therapy. The subjects will be~     followed for 2 years. The primary objective is to compare the time to worsening to a medium~     level of concern as defined by the Canadian Multiple Sclerosis Working Group (CMSWG)~     treatment optimization recommendations.~   "
263336|NCT00101946|"~     This study will evaluate the effectiveness and safety of the investigational drug 683699 in~     treating subjects with moderately to severely active CD (Crohn's Disease).~   "
263337|NCT00101933|"~     The purpose of this research is to study the safety and effectiveness of bilateral~     stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the~     frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset~     seizures, with or without secondary generalization, that are refractory to antiepileptic~     medications.~   "
263363|NCT00101595|"~     The purpose of this clinical research study is to learn if BMS-354825 will have activity as~     defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid~     leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary~     or acquired resistance to imatinib mesylate.~   "
263477|NCT00100035|"~     The purpose of this study is to assess the effectiveness of polarity therapy (PT), a~     complementary and alternative medicine treatment, in American Indian caregivers living in the~     Pacific Northwest.~   "
263338|NCT00101920|"~     Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in~     kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor~     prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor~     types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth.~     Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal~     antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a~     Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in the treatment of~     advanced NSCLC following failure of paclitaxel and carboplatin therapy on treatment arm 1 of~     Immunex Protocol 054.0004 (Amgen Protocol 20025404), Part 2.~   "
263339|NCT00101907|"~     The purpose of this study is to characterize the safety and tolerability of AMG 706 plus~     panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b~     clinical study.~   "
263340|NCT00101894|"~     The purpose of this study is to characterize the safety and tolerability of AMG 706 plus~     panitumumab when administered with either FOLFIRI or FOLFOX4 chemotherapy regimens. This is a~     Phase 1b clinical study.~   "
263341|NCT00101881|"~     The study compares the effectiveness of two fully approved shock waveforms (monophasic and~     biphasic shock) commonly used to defibrillate (shock) patients with out-of-hospital cardiac~     arrest due to a highly lethal rhythm problem (ventricular fibrillation). The purpose of the~     study (hypothesis) is to determine if one waveform results in improved resuscitation,~     admission alive to hospital, and discharge alive from hospital compared with the other.~   "
263342|NCT00101868|"~     The transition from hospital to home is a high-risk period in a patient's illness. Poor~     communication between healthcare providers at hospital discharge is common and contributes to~     adverse events affecting patients after discharge. The importance of good communication at~     discharge will increase as more primary care providers delegate inpatient care to~     hospitalists. Any process that improves information transfer among providers at discharge~     might improve the health and safety of patients discharged from U.S. hospitals each year, and~     to appreciably reduce unnecessary healthcare expenditures. Information transfer among~     healthcare providers and their patients can be undermined because of inaccuracies, omissions,~     illegibility, logistical failure (e.g., information is never delivered), and delays in~     generation (i.e., dictation or transcription) or transmission. Root causes include recall~     error, increased physician workloads, interface failures (e.g., physician-clerical) and poor~     training of physicians in the discharge process. Many of the deficiencies in the current~     process of information transfer at hospital discharge could be effectively addressed by the~     application of information technology. The proposed study will measure the value of a~     software application to facilitate information transfer at hospital discharge. The study is~     designed to compare the benefits of discharge health information technology versus usual care~     in high-risk patients recently discharged from acute care hospitalization. The design is a~     randomized, single-blind, controlled trial. The outcomes are readmission within 6 months,~     adverse events, and effectiveness and satisfaction with the discharge process from the~     patient and physician perspectives. The cost outcome is the physician time required to use~     the discharge software.~   "
263343|NCT00101855|"~     This study is a randomized controlled trial of an evidence based, patient specific web site's~     ability to improve preventive practices in pediatric care. Parents visit the website within 2~     weeks of a scheduled well child visit and are presented with a menu of age specific topics~     that they can read about as they wish.~   "
263344|NCT00101842|"~     The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and~     Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic~     transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and~     Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated~     with the combination of these drugs; To determine whether Gemcitabine and Platinol followed~     by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To~     determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make~     your tumor smaller or disappear, and for how long.~   "
263345|NCT00101829|"~     The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in~     treating patients with Sjogren's syndrome (SS). Rituximab is a laboratory-made antibody~     currently used to treat some kinds of lymphoma. Rituximab may also help people with SS, a~     disease of the immune system. However, the safety of rituximab in SS patients must first be~     established.~   "
263346|NCT00101816|"~     The purpose of this study is to see what effect an investigational drug (BMS-354825) has on~     subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and~     who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study~     is to see what side effects this drug may have on subjects.~   "
263347|NCT00101803|"~     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a~     single oral drug. The purpose of this study is to assess the safety and effectiveness of the~     combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood~     glucose levels in people with type 2 diabetes who have not previously been treated with drug~     therapy to lower their blood sugar.~   "
263348|NCT00101790|"~     The purpose of this study is to determine the test dose of pamidronate for treatment of low~     back pain in terms of safety, tolerability, and pain relief.~   "
263364|NCT00101582|"~     The purpose of this research study is to test the safety and effectiveness of palifermin to~     determine if weekly doses can be safely administered to reduce the incidence (occurrence of),~     duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in~     the mouth). Mucositis is a common side effect for patients receiving chemotherapy~     (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and~     neck cancer (HNC).~   "
263365|NCT00101569|"~     The purpose of this trial is to study liquid aripiprazole in patients with stable~     schizophrenia.~   "
263393|NCT00101166|"~     The purpose of this study is to find out what effects (good and/or bad) this new cancer~     vaccine has on the patient and their cancer, whether it is safe and whether it can help get~     rid of their cancer (malignant melanoma). We want to check how the patient's immune system~     reacts, both before and after the vaccine treatment.~   "
263478|NCT00100009|"~     This study will test the safety and effectiveness of combining a laser treatment called~     photodynamic therapy, or PDT, with injections into the eye of the steroid triamcinolone~     acetonide for treating age-related macular degeneration (AMD). The macula is the part of the~     retina in the back of the eye that determines central or best vision. AMD can severely impair~     central vision, affecting a person's ability to read, drive, and carry out daily activities.~     This vision loss is caused by the formation of abnormal blood vessels behind the retina that~     leak blood under the macula. PTD stops the growth of these blood vessels and slows the rate~     of vision loss; however, it has only a temporary effect and does not work in all patients.~     Furthermore, it may actually cause some swelling and re-growth of blood vessels.~     Triamcinolone acetonide can help lessen swelling and scarring.~      Patients 50 years of age and older with AMD may be eligible for this study. Candidates are~     screened with a medical history, medical evaluation, and eye examinations (see below).~     Participants are randomly assigned to one of three treatment groups: 1) PDT plus 1 mg TAC-PF;~     2) PDT plus 4 mg TAC-PF; or 3) PDT plus sham injection (a syringe with no needle is pressed~     against the eye). Treatments are given the day the patient enrolls in the study and then~     every 3 months for 2 years, as long as the therapy is thought beneficial. Patients who must~     discontinue TAC-PF injections may still be treated with PDT if medically necessary. In~     addition to treatment, patients undergo the following tests and procedures:~        -  Eye examination: Visual acuity and eye pressure are measured, and the lens, retina,~          pupils and eye movements are examined.~        -  Fundus photography: Photographs of the back of the eye are taken using a special camera~          with a bright flash.~        -  Lens photography: Photographs of the lens are taken to look for development of~          cataracts.~        -  Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood~          vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in~          the eyes. The retina is photographed using a camera that flashes a blue light into the~          eye. The pictures show if any dye has leaked from the vessels into the retina,~          indicating possible blood vessel abnormality.~        -  Optical coherence tomography: This test uses light to produce a 2-dimensional~          cross-sectional picture of the retina. The patient looks into a machine called an~          optical coherence tomograph at a pattern of flashing and rotating red and green lights,~          first with one eye and then the other.~        -  PDT: A needle is placed in an arm vein and a drug called verteporfin (Visudyne®~          (Registered Trademark)) is infused into the vein over 10 minutes. After 15 minutes, the~          eye is anesthetized with numbing drops. A special contact lens is then placed on the eye~          and the laser beam is directed to the eye for 83 seconds.~        -  TAC-PF or injections (for those in the TAC-PF treatment groups): Numbing and anesthetic~          drops are placed on the surface of the eye before injection of TAC-PF. Another~          anesthetic is then applied to the lower part of the eye with a cotton swab. After a few~          minutes, TAC-PF is injected into the vitreous (jelly-like substance inside the eye).~          Patients receiving sham injections undergo the identical procedure, except a syringe~          with no needle is pressed against the eye to seem like a real injection. All patients~          receive antibiotic drops to put in their eye for 2 days after each treatment. Patients~          return to the clinic anytime from 2 to 7 days after each treatment for a check of~          vision, eye pressure, and treatment side effects.~      Patients are seen in the clinic for additional checks at 4 weeks and 4 months after the first~     treatment.~   "
263349|NCT00101777|"~     The importance of the proposed research project derives from a steady accumulation of~     research findings on the relationship between respiration and anxiety. The relationship~     between panic disorder and abnormalities in respiration has been recognized for more than 10~     years. Increased sensitivity to CO2 exposure in panic disorder represents the most consistent~     finding supporting this relationship. The current proposal follows naturally from three sets~     of recent research findings in the area of panic disorder. First, our group has recently~     shown that children with anxiety disorders, like adults with panic disorder, exhibit~     increased sensitivity to CO2. Second, other researchers have shown that psychiatrically~     healthy relatives of patients with panic disorder also exhibit increased sensitvity to CO2.~     Finally, our group has also recently shown that children of adults with panic disorder~     exhibit high rates of anxiety disorders, particularly separation anxiety disorder, the~     childhood anxiety disorder which exhibits the highest degree of CO2 sensitivity. These three~     findings suggest that children of parents with panic disorder may exhibit a latent~     vulnerability to panic disorder, manifested as increased sensitivity to CO2.~      A secondary feature of the proposed research project derives from a steady accumulation of~     research findings in basic science literature outlining the parts of the brain that mediate~     fear and anxiety in animals. It may be possible to use insights from research on the brain~     basis of fear in animals to develop methods for assessing the brain basis of fear in humans.~     Moreover, work in animals notes changes in brain systems that mediate fear and anxiety across~     development. If development. If developmentally sensitive methods could be used to study fear~     in children, it may also be possible to greatly enhance our understanding of the manner in~     which the relationship between brain function and fear changes as children age. If~     similarities could be demonstrated across animals and humans in these areas, new insights on~     potential treatments for anxiety could be more readily transferred from the laboratory to the~     clinic. A second goal of the current proposal is to refine two neuropsychological probes that~     are thought to assess functional aspects of brain systems implicated in fear and anxiety~     across various species, from rodents to humans.~   "
263350|NCT00101764|"~     The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be~     a promising treatment for a variety of ocular diseases associated with inflammation. To date,~     the only drug available, Kenalog-40 Injection produced by Bristol Myers Squibb, has not~     been formulated for intraocular use.~      The purpose of this study is to evaluate the long-term safety and potential efficacy of novel~     intravitreal injections of a preservative-free formulation of triamcinolone acetonide~     (TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of~     TAC-PF at 20 mg.~      The study will be a masked, randomized Phase I study that will enroll 120 participants with~     one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema~     (DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any~     other retinal disease with associated macular edema. At least 21 participants will be~     enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36~     participants may have one of these diseases or may be enrolled with another retinal disease.~     Within each disease strata, at least seven participants will be randomized to each dosing~     group. The participants will be randomly assigned to one of the three treatment groups.~      The primary outcome will be an assessment of post-injection intraocular toxicity-related~     events during the 3-year follow-up, including cataract formation, development of glaucoma,~     and any adverse event preventing retreatment. The secondary outcomes will be an improvement~     in best-corrected visual acuity (BCVA, EVA) and decreases in retinal thickening and area of~     leakage, from baseline to year 1.~   "
263351|NCT00101751|"~     This trial is conducted in the United States of America (USA). The purpose of this study is~     to compare the effectiveness and safety of a biphasic insulin aspart standard titration~     regimen when coupled with dietary intervention to standard titration without dietary~     intervention.~   "
263352|NCT00101738|"~     The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have~     comparable kidney function results in kidney transplant patients.~   "
263353|NCT00101725|"~     This study is designed to evaluate the safety and effectiveness of an investigational drug,~     TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome~     (IBS).~   "
263354|NCT00101712|"~     This study is not being conducted in the United States. Key long-term clinical studies have~     shown that people with type 2 diabetes should try to achieve overall blood glucose levels as~     close to normal as possible. The purpose of this study is to assess the safety and~     effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall~     blood glucose levels in people with type 2 diabetes who have not been previously treated with~     drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.~   "
263355|NCT00101699|"~     The purpose of this study is to examine the way soy consumption affects menopausal symptoms~     in middle-aged Japanese women.~   "
263356|NCT00101686|"~     This study compares in the first study period combination of Irinotecan with three different~     methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second~     period of study it compares FOLFIRI [a chemotherapy regime that combines bolus irinotecan and~     leucovorin [LV] with infusional 5-fluorouracil (5-FU)] + bevacizumab and mlFL + bevacizumab.~     Measures of efficacy and safety will be reported.~   "
263357|NCT00101673|"~     This study was not conducted in the United States. The purpose of this study was to assess~     the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering~     overall blood glucose levels in people with type 2 diabetes who had not previously been~     treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a~     specified range.~   "
263358|NCT00101660|"~     The purpose of this study is assess the effects of the investigational drug dasatinib on~     participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and~     who are either resistant to or intolerant of imatinib. Other purposes of the study are to~     identify any side effects the drug may produce and to study the level of dasatanib in the~     blood and assess the efficacy of dasatanib in the treatment of leukemia.~   "
263359|NCT00101647|"~     The purpose of this clinical research study is to learn if BMS-354825 will have activity,~     defined by hematologic response, in subjects who have accelerated phase chronic myeloid~     leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this~     treatment will also be studied.~   "
263360|NCT00101634|"~     The purpose of this study is to determine the efficacy (how well the drug works), safety, and~     side effects of paliperidone palmitate compared to placebo in the treatment of the symptoms~     of schizophrenia in adults. The placebo used in this study was a nutritional substance known~     as 20% Intralipid emulsion given to patients requiring intravenous feedings.~   "
263361|NCT00101621|"~     M40403 was found to be effective in reducing pain in animal models and in clinical studies of~     subjects who were experiencing pain after dental surgery. The proposed study is designed to~     investigate the efficacy and safety of M40403 when co-administered with an opioid in subjects~     with pain due to cancer.~   "
263362|NCT00101608|"~     The purpose of this clinical research study is to learn if vinflunine can shrink or slow the~     growth of the cancer or increase survival in patients with transitional cell carcinoma of the~     urothelium. The safety of this treatment will also be studied.~   "
263366|NCT00101543|"~     Conventional rehabilitation does not restore normal, safe gait to many stroke survivors.~     Functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM)~     improved persistent gait deficits for patients with chronic stroke (1-7 years post stroke),~     but required a long protocol of 6-18 months. For chronic deficits, a shortened response to~     treatment (3 months) was obtained by combining FNS-IM with body weight-supported treadmill~     training (BWSTT). Gains included strength, coordination, gait kinematics, walking endurance,~     and quality of life. Gait deficits treated in the chronic phase are more resistant to~     treatment than in the early recovery phase, because chronic, abnormal movement patterns are~     more ingrained. Therefore, during the early recovery phase, it is likely that a relatively~     greater treatment response will be obtained. The purpose of the proposed work is to test the~     combination FNS-IM + BWSTT during the early recovery phase following stroke. Hypothesis I is:~     FNS-IM + BWSTT will restore volitional gait more completely for subjects during the early~     recovery phase following stroke, compared to BWSTT alone. Subjects will be admitted at 1-11~     months after stroke. Thirty five subjects will be randomized to one of the two treatment~     groups. They will be treated for 48 sessions, four sessions/week. Primary outcome measures~     will be: kinematic swing phase gait components, energy cost of gait, and an index of walking~     endurance. Secondary outcome measures will be kinematic stance phase gait components and gait~     speed. The second set of hypotheses will test the relationship between restoration of~     mobility and measurements of impairment, function and quality of life.~   "
263367|NCT00101530|"~     The purpose of the study is to improve cardiovascular disease (CVD) outcomes in racial and~     ethnic minorities. Specifically, it seeks to improve the primary prevention of CVD in~     Hispanics.~   "
263368|NCT00101517|"~     The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and~     ethnic minorities. Specifically, the study seeks to systematically characterize potential~     ethnic differences in obesity-related CVD by drawing upon the fields of psychology,~     physiology, biochemistry, nursing, and clinical medicine.~   "
263369|NCT00101504|"~     The purpose of this study is to improve hypertension outcomes in racial and ethnic~     minorities.~   "
263370|NCT00101491|"~     The purpose of this study is to develop and test an intervention based on~     literacy-appropriate electronic tools, tailored to the demographics and readiness for change~     of the user, to promote tobacco smoking cessation in a low-literacy population.~   "
263371|NCT00101478|"~     The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and~     ethnic minorities. Specifically, the study will aim to improve provider and patient~     approaches to treatment of hypertension and diabetes, respectively.~   "
263372|NCT00101465|"~     The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and~     ethnic minorities in Hawaii.~   "
263373|NCT00101452|"~     The purpose of this study is to determine the safety and effectiveness of~     s-adenosyl-l-methionine (SAMe) in treating major depression.~   "
263374|NCT00101439|"~     A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with~     primary hypercholesterolemia (high cholesterol) after eating a meal that is high in~     cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the~     cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a~     cholesterol-enriched test meal.~   "
263375|NCT00101426|"~     This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase~     inhibitor in patients with diabetic sensorimotor polyneuropathy.~   "
263376|NCT00101413|"~     The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long~     the effect continues, if the patients receiving BAY43-9006 will live longer.~        -  If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung~          cancer.~        -  If BAY43-9006 helps to slow the worsening of non-small cell lung cancer.~        -  If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their~          metastases.~   "
263377|NCT00101400|"~     The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006~     (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other~     organs of body despite treatment that the patient has received so far.~   "
263378|NCT00101387|"~     The purpose of this study is to determine whether a form of electrical acupuncture, called~     percutaneous electrical nerve stimulation (PENS), can reduce pain and disability in older~     adults with chronic low back pain (LBP). This study will also determine the effects of~     general conditioning and aerobic exercise (GCAE) on chronic LBP.~   "
263379|NCT00101374|"~     This study will evaluate the effect of leflunomide on the life cycle of a specific immune~     cell called CD4+ T cell in HIV-infected patients. Leflunomide is approved by the Food and~     Drug Administration for treating rheumatoid arthritis. It works by blocking cell division in~     activated T cells. In HIV infection, the HIV virus causes increased activation of T cells.~     The activated cells become infected and die. Activation may also cause the death of T cells~     that are not infected with HIV. T cells are necessary for the body to fight infections and~     cancer. This study will see if leflunomide can block T-cell division and possibly reduce the~     number of cells that die, reduce the number of cells in which HIV can reproduce, and lead to~     a lower level of HIV virus in the body.~      HIV-infected patients between 18 and 65 years of age who have 1) HIV viral levels of 1,000~     copies/mL or more, 2) a CD4+ T-cell count of 350 cells/mm3 or more, and 3) a CD4+ T-cell~     count that has never been less than 200 cells/mm3 may be eligible for this study. Candidates~     are screened with a medical history, physical examination, blood and urine tests, chest~     x-ray, and electrocardiogram (EKG).~      Participants are randomly assigned to take leflunomide or placebo (a substance with no active~     ingredient) every day for 28 days. They come to the clinic three times during the first 29~     days of the study (days 1, 15, and 29) for a physical examination and review of any drug side~     effects. Patients taking placebo end their participation on day 29. Patients taking~     leflunomide stop taking the drug on day 29 and begin taking cholestyramine three times a day~     for 11 days out of the next 14 days to clear the leflunomide from their body. On day 43, they~     return to the clinic to have their leflunomide level checked to make sure that only very~     little or none of the drug remains in the body. If the level is low, patients end their~     participation on or around day 57. If the level remains high, they repeat the cholestyramine~     treatment.~   "
263392|NCT00101179|"~     MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     MS-275 together with azacitidine may kill more cancer cells. This phase I trial is studying~     the side effects and best dose of MS-275 when given together with azacitidine in treating~     patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid~     leukemia.~   "
263435|NCT00100581|"~     A significant proportion of HIV infected people in the U.S. are also infected with hepatitis~     C virus (HCV). The purpose of this study is to determine the effects of anti-HIV therapy on~     treatment of HCV with pegylated interferon alfa-2a and ribavirin (PEG/RBV).~   "
263380|NCT00101361|"~     This study is designed to determine whether the use of oxandrolone, an anabolic steroid, can~     heal pressure ulcers in persons with spinal cord injury (SCI). In a Feasibility Study, three~     VA SCI Units will screen and randomize patients into treatment with oxandrolone or with~     placebo. Eleven other sites will screen patients to determine eligibility but will not treat~     patients with the agent. Following the Feasibility Study, all sites will participate in a~     blinded, randomized treatment study. A total of 400 patients will be enrolled over a~     four-year period. Any patient in a participating unit who has chronic SCI and a~     difficult-to-heal pelvic ulcer will be eligible for the study if other entry criteria are~     met. All enrolled patients will be followed for a period of 24 weeks to determine whether~     their target pressure ulcers heal. Those who are healed will be followed for an additional~     four weeks to determine whether the ulcer remains healed.~   "
263381|NCT00101348|"~     This randomized phase I/II trial studies the side effects, best way to give, and best dose of~     erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and~     cetuximab together with or without bevacizumab works in treating patients with metastatic or~     unresectable kidney, colorectal, head and neck, pancreatic, or non-small cell lung cancer.~     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Cetuximab and bevacizumab~     may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib~     together with cetuximab and/or bevacizumab may kill more tumor cells.~   "
263382|NCT00101335|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of celecoxib may prevent or treat head and neck cancer.~      PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works~     compared to placebo in preventing head and neck cancer in patients with oral leukoplakia.~   "
263383|NCT00101309|"~     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body~     build an effective immune response to kill tumor cells. Interleukin-2 (IL-2) may stimulate~     the white blood cells to kill tumor cells. Biological therapies, such as cellular adoptive~     immunotherapy, stimulate the immune system and stop tumor cells from growing. Giving vaccine~     therapy with IL-2 may be a more effective treatment for Ewing's sarcoma or neuroblastoma.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given with~     IL-2 in treating young patients with relapsed or refractory Ewing's sarcoma or neuroblastoma.~   "
263384|NCT00101296|"~     Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. This phase I trial is studying the side effects and best dose of tipifarnib in~     treating patients with relapsed or refractory acute myeloid leukemia~   "
263385|NCT00101283|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with~     gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating~     malignant pleural mesothelioma.~      PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and~     pemetrexed disodium with carboplatin to see how well the combinations work compared to~     historical controls in treating patients with advanced malignant pleural mesothelioma.~   "
263386|NCT00101270|"~     This phase I trial is studying the side effects and best dose of oxaliplatin when given~     together with irinotecan in treating young patients with refractory solid tumors or~     lymphomas. Drugs used in chemotherapy, such as oxaliplatin and irinotecan, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Oxaliplatin may help irinotecan kill more cancer cells by making cancer cells more~     sensitive to the drug. Giving oxaliplatin together with irinotecan may kill more cancer~     cells.~   "
263387|NCT00101257|"~     RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the~     immune system in different ways and stop tumor cells from growing.~      PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive~     immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary~     peritoneal cancer.~   "
263388|NCT00101244|"~     This phase I trial is studying the side effects and best dose of SB-715992 in treating~     patients with metastatic or unresectable solid tumors or Hodgkin's or non-Hodgkin's lymphoma.~     Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing~   "
263389|NCT00101231|"~     This phase I trial is studying the side effects and best dose of flavopiridol in treating~     patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or~     chronic myelogenous leukemia. Drugs used in chemotherapy, such as flavopiridol, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing.~   "
263390|NCT00101205|"~     This phase I trial is studying the side effects and best dose of oxaliplatin and etoposide in~     treating young patients with recurrent or refractory solid tumors or lymphomas. Drugs used in~     chemotherapy, such as oxaliplatin and etoposide, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may~     also help etoposide work better by making cancer cells more sensitive to the drug. Giving~     oxaliplatin together with etoposide may kill more cancer cells.~   "
263391|NCT00101192|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Cetuximab may also help cisplatin~     work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy,~     such as cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin~     may be a better way to block tumor growth.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin~     works in treating patients with advanced, persistent, or recurrent cervical cancer.~   "
275018|NCT00000525|"~     To determine whether hypertensive patients with ECG abnormalities and receiving~     hydrochlorothiazide diuretics were at increased risk of sudden death.~   "
263394|NCT00101153|"~     RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as cytarabine and daunorubicin, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving tipifarnib together with cytarabine and daunorubicin may~     kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when~     given with cytarabine and daunorubicin in treating older patients with acute myeloid~     leukemia.~   "
263395|NCT00101140|"~     RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that~     were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a~     donor can make an immune response against the body's normal cells. Giving total-body~     irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant~     may stop this from happening.~      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in~     treating patients with acute myeloid leukemia in remission.~   "
263396|NCT00101127|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the~     number of immune cells found in bone marrow or peripheral blood and may help the immune~     system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine~     together with G-CSF or pegfilgrastim may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together~     with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or~     recurrent uterine leiomyosarcoma.~   "
263397|NCT00101114|"~     This phase II trial is studying how well giving sorafenib with interferon alfa works in~     treating patients with metastatic or unresectable kidney cancer. Sorafenib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa~     may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib~     may help interferon alfa work better by making tumor cells more sensitive to the drug~   "
263398|NCT00101101|"~     RATIONALE: Vaccines made from gene-modified cells and a person's cancer cells may make the~     body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may~     stimulate the white blood cells to kill cancer cells. Giving booster vaccinations may make a~     stronger immune response and prevent or delay the recurrence of cancer. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)~     may kill more cancer cells. Giving vaccine therapy together with IL-2 after combination~     chemotherapy may be a more effective treatment for mantle cell lymphoma.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with IL-2~     after combination chemotherapy works in treating patients with relapsed or de novo stage II,~     stage III, or stage IV mantle cell lymphoma.~   "
263399|NCT00101088|"~     This phase I trial is studying the side effects and best dose of temsirolimus when given with~     imatinib mesylate in treating patients with chronic myelogenous leukemia. Drugs used in~     chemotherapy, such as temsirolimus, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving temsirolimus with imatinib mesylate may kill more cancer cells~   "
263400|NCT00101075|"~     The goal of this clinical research study is to find out how effective oxaliplatin and~     capecitabine are against advanced cancer of the salivary gland. The safety of this treatment~     as well as how long the cancer responds or stays in a stable state due to the treatment will~     also be studied.~   "
263401|NCT00101062|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by lowering the amount of estrogen the body makes.~     Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating~     postmenopausal women with locally advanced or metastatic breast cancer.~   "
263402|NCT00101036|"~     This phase II trial is studying how well lapatinib works in treating patients with locally~     advanced or metastatic biliary tract or liver cancer that cannot be removed by surgery.~     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
263403|NCT00101010|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving rituximab together with combination chemotherapy may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy works in treating older patients with diffuse large B-cell lymphoma.~   "
263404|NCT00100997|"~     RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. It may also stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     17-N-allylamino-17-demethoxygeldanamycin in treating patients with chronic phase chronic~     myelogenous leukemia that did not respond to imatinib mesylate.~   "
263405|NCT00100984|"~     The main objective of this study is to compare the safety and efficacy of an enfuvirtide~     containing regimen to a nucleoside combination regimen. Resistance information will also be~     collected.~   "
263406|NCT00100971|"~     RATIONALE: Vaccines made from a person's white blood cells and cancer cells may make the body~     build an effective immune response to kill cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with acute myeloid leukemia.~   "
263436|NCT00100568|"~     The purpose of this study is to determine the safety and effectiveness of the anti-HIV drugs~     efavirenz and lamivudine/zidovudine given to treatment-naive HIV-infected people in Dakar,~     Senegal.~   "
263407|NCT00100958|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of indole-3-carbinol may prevent cancer.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of~     indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in~     healthy participants.~   "
263408|NCT00100945|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with~     locally advanced esophageal cancer.~   "
263409|NCT00100932|"~     This is a study of E7389 in patients with recurrent and/or metastatic Non-Small-Cell Lung~     Cancer (NSCLC) who progressed during or after treatment with a platinum agent and another~     chemotherapy.~   "
263410|NCT00100919|"~     This study will collect information on how people sense leg position and movement. The~     findings may help scientists develop better ways to evaluate and treat joint problems.~      Healthy adult volunteers between 21 and 40 years of age may be eligible for the study.~     Candidates are screened with a brief questionnaire and examination to determine their~     strength, flexibility, and sensation.~      Participants sit on a specially designed chair, with their foot and leg placed in a~     custom-made apparatus that controls knee and ankle movements. The skin is marked to indicate~     the area of interest for ultrasound assessment of muscle. Subjects respond to joint position~     changes for several trials. The procedure takes a maximum of 2.5 hours to complete.~   "
263411|NCT00100906|"~     RATIONALE: Tretinoin may help cells that are involved in the body's immune response to work~     better. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving~     tretinoin together with interleukin-2 may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving three different doses of~     tretinoin together with interleukin-2 works in treating patients with stage IV kidney cancer.~   "
263412|NCT00100893|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of IH636 grape seed extract may prevent breast cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed~     extract in preventing breast cancer in postmenopausal women at risk of developing breast~     cancer.~   "
263413|NCT00100880|"~     This phase I trial is studying the side effects and best dose of lenalidomide in treating~     young patients with recurrent, progressive, or refractory CNS tumors. Lenalidomide may stop~     the growth of CNS tumors by blocking blood flow to the tumor. It may also stimulate the~     immune system in different ways and stop tumor cells from growing.~   "
263414|NCT00100867|"~     In clinical trials being conducted throughout the world, pregnant HIV-infected women are~     given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child~     transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown.~     The purpose of this study is to determine the safety, toxicity, and potential side effects of~     maternal anti-HIV treatment on infants born to these HIV-infected women.~      Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in~     diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding~     periods, and are not associated with adverse side effects to the fetus, neonate, and/or~     breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV~     transmission.~   "
263415|NCT00100854|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells.~     Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount~     of estrogen the body makes. Giving erlotinib together with fulvestrant may kill more tumor~     cells. It is not yet known whether giving erlotinib together with fulvestrant is more~     effective than erlotinib alone in treating non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying giving erlotinib together with~     fulvestrant to see how well it works compared to erlotinib alone in treating patients with~     stage IIIB or stage IV non-small cell lung cancer.~   "
263416|NCT00100841|"~     Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability~     of tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer~     by blocking blood flow to the tumor. Giving combination chemotherapy together with~     bevacizumab and cetuximab may kill more tumor cells. This phase II trial is studying how well~     giving combination chemotherapy together with bevacizumab and cetuximab works in treating~     patients with stage IV colorectal cancer that cannot be removed by surgery.~   "
263417|NCT00100828|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with~     metastatic or inoperable thyroid cancer.~   "
263418|NCT00100815|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to~     the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine~     together with bevacizumab works in treating patients with metastatic or unresectable~     pancreatic cancer.~   "
263419|NCT00100802|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     radiation therapy together with temozolomide and lomustine after surgery may kill any~     remaining tumor cells.~      PURPOSE: This phase II trial is studying how well giving radiation therapy together with~     temozolomide and lomustine works in treating young patients with newly diagnosed gliomas.~   "
263437|NCT00100555|"~     The purpose of this trial is to study the clinical safety, tolerability, and efficacy of~     zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.~   "
275019|NCT00000524|"~     To determine whether immunosuppressive treatment improved cardiac function in patients with~     biopsy-proven myocarditis.~   "
263420|NCT00100789|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel~     works in treating patients with persistent, recurrent, or metastatic head and neck cancer.~   "
263421|NCT00100776|"~     The purposes of this study are to assess the efficacy, safety, and side effects among doses~     approved by the Food and Drug Administration and higher (not FDA approved) doses of~     olanzapine in patients with schizophrenia or schizoaffective disorder.~   "
263422|NCT00100750|"~     This phase I/II trial is studying the side effects and best dose of tipifarnib when given~     together with gemcitabine hydrochloride and to see how well they work in treating women with~     breast cancer that has spread to other parts of the body. Tipifarnib is a drug that binds to~     specific proteins on the tumor cells and then kills these cells. Gemcitabine hydrochloride is~     a chemotherapy drug that may kill tumor cells by preventing cells from dividing. Giving~     tipifarnib together with gemcitabine hydrochloride may kill more tumor cells.~   "
263423|NCT00100737|"~     The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8~     weeks in combination with rituximab is effective and safe when compared to rituximab given~     alone in the treatment of follicular NHL subjects that have never received rituximab as a~     treatment and are refractory or relapsed after previous chemotherapy.~   "
263424|NCT00100724|"~     The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given~     intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.~   "
263425|NCT00100711|"~     The primary purpose of this study is to determine if motexafin gadolinium may be an effective~     treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma~     (SLL). Secondly, the duration of response and the time during which patients survive without~     chronic lymphocytic leukemia or small lymphocytic lymphoma worsening will be evaluated.~     Additionally, the patient's response to motexafin gadolinium will be compared to the response~     of the patient's cells in a laboratory to motexafin gadolinium.~   "
263426|NCT00100698|"~     This study will investigate long-term, low-dose growth hormone administration in HIV-infected~     patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We~     hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will~     include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood~     pressure,bone density, cardiovascular risk and safety parameters.~   "
263427|NCT00100685|"~     This clinical trial is being conducted to determine tumor response and preliminary safety of~     a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) and~     is required for the establishment of new blood vessels during tumor growth, a process known~     as angiogenesis.~   "
263428|NCT00100672|"~     The primary purpose of this study is to identify a dose of Liposome Entrapped c-raf Antisense~     Oligonucleotide Easy-to-Use (LErafAON-ETU) which maximizes potential benefits of the compound~     to patients with advanced cancer, without compromising their safety. This study will also~     assess the processing of LErafAON-ETU by the body over time. Patients will receive an~     intravenous infusion of LErafAON-ETU each week. Multiple blood samples will be taken for~     pharmacokinetic analysis during the first treatment; two samples will be taken during both~     the second and third treatments. Patients will be eligible to continue treatment until the~     occurrence of unacceptable toxicity or disease progression.~      In LErafAON-ETU, antisense oligonucleotides specific to c-raf, are associated with liposomes,~     which are microscopic membrane-like structures created from lipids (fats). Raf-1 is a protein~     which plays a critical role in many aspects of cellular activation and growth. Therefore, it~     is thought to be an important factor that may support tumor development. LErafAON-ETU~     potentially limits the ability of a cell to produce the Raf-1 protein.~   "
263429|NCT00100659|"~     The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a~     (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic~     hepatitis C virus (CHC) infection in children.~      The purpose of this study is also to determine whether PEG-2a in combination with RV or~     PEG-2a alone will result in a longer response rate in children with CHC.~   "
263430|NCT00100646|"~     HIV infected people often must take anti-HIV drugs for long periods, leading to long-term~     drug exposure and toxicity. Interruptions in anti-HIV therapy, also known as structured~     treatment interruptions (STIs), may have few negative health effects and may be helpful to~     the overall long-term health of HIV-infected people. The purpose of this study is to~     determine if sequential short-term STIs of antiretroviral therapy (ART) in HIV infected~     individuals in a resource-constrained environment can retain the immune reconstitution~     benefits of continuous treatment while potentially lessening rates of toxicity associated~     with continuous therapy strategies and at the same time, lessen costs associated with ART.~   "
263431|NCT00100633|"~     The purpose of the study is to determine the safety of and immune response to a hepatitis B~     virus vaccine series given with a boosting agent, CpG7909 oligodeoxynucleotides (ODN), in HIV~     infected and HIV uninfected individuals who previously failed to develop a response to~     hepatitis B vaccine.~      Study hypothesis: Administration of CpG7909 ODN together with recombinant hepatitis B vaccine~     will result in increased frequency and magnitude of response to vaccine in individuals who~     have previously failed to mount a response to vaccination, and that in HIV infected subjects~     with detectable plasma viremia, it will lead to the enhancement of HIV-specific responses.~   "
263432|NCT00100620|"~     The intake of high doses of corticosteroids is known to play an important role in the~     weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is~     a drug known for its protective effect in some bone diseases (tumors, paget). This study will~     test the safety and efficacy of zoledronic acid in the prevention and treatment of~     corticosteroid induced osteoporosis in male and female patients.~   "
263433|NCT00100607|"~     This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone~     mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with~     osteoporosis.~   "
263434|NCT00100594|"~     The purpose of this study is to determine the safety, effectiveness, and tolerability of the~     anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV infected~     people in Wenxi County, Shanxi Province, China.~   "
263439|NCT00100529|"~     This study will use stereo photogrammetry to: 1) characterize facial features of genetic and~     congenital malformations; 2) define facial features associated with normal growth and~     development; and 3) determine if stereo photogrammetry soft tissue imaging can be used to~     help diagnose head and facial malformations. These abnormalities currently are diagnosed~     using 2- or 3-dimensional skeletal images obtained with x-rays. Stereo photogrammetry uses a~     camera and computer to generate 3-dimensional images of the soft tissues of the face. Because~     the method does not use any radiation, images can be taken repeatedly to evaluate patients~     over a long term.~      Using stereo photogrammetry, images of people who belong to a defined group, for example,~     17-year-old Caucasian males, can be combined (or morphed) into one image, allowing~     measurement of the facial features of the group. Comparing the morphed images of a normal~     control group with those of people with specific genetic conditions may reveal distinctions~     that could be used in diagnosing conditions that are currently diagnosed using x-rays.~      Healthy normal volunteers and patients with craniofacial dysmorphologies may be eligible for~     this study. Patients are recruited from current NIH studies of various genetic diseases.~     People who have previously had head and neck surgeries, including cosmetic surgery, may not~     participate.~      Participants give a medical and dental history, including any orthodontic work or facial~     surgeries. They are then positioned in front of a photogrammetry camera, a headband is placed~     on their head, and their picture is taken. A coded patient number is entered into the~     computer, where the image is stored until further analysis. Most participants are evaluated~     one time, but some patients and control subjects may be asked to return yearly for repeat~     images.~   "
263440|NCT00100516|"~     This study will evaluate the differences between open surgical kidney donation and~     laparoscopic kidney donation on kidney donors and recipients. Both procedures are standard~     surgeries used to remove kidneys for donation, and they are done equally often. Open surgical~     kidney donation involves removing the donor kidney through a 3- to 5-inch surgical incision.~     Laparoscopic donation involves making several small holes in the skin and removing the kidney~     through a larger hole, while directly watching the kidney with a camera. The study will~     correlate the effects of both procedures with donor and recipient kidney function, urine~     output, post-operative pain, and return to work after surgery.~      Adults without kidney disease who are willing to donate a kidney to a patient enrolled in a~     clinical transplant protocol at the NIH Clinical Center may be eligible for this study.~     Donors and recipients must be enrolled in the NIDDK protocol, Live Donor Renal Donation for~     Allotransplantation (protocol #99-DK-0107).~      Donors and patients undergo the following procedures:~        -  Infrared imaging (measurement of small differences in temperature using a special~          camera) during surgery to look at blood flow to the kidney during the operation (both~          donor and recipient surgical procedures). The pictures provide images of the blood~          vessels in the kidney and measure how the blood flow changes.~        -  Kidney biopsy (removal of a small piece of kidney tissue). The patient's failed kidney~          is biopsied once during transplant surgery when it is removed. The donor's kidney is~          biopsied twice - once during surgery to remove the organ from the donor and again after~          transplant into the recipient.~        -  Evaluations after surgery of post-operative urine output, blood pressure, and pain, and~          length of hospital stay and return to work.~   "
263441|NCT00100503|"~     This study will examine how therapy changes the way the brain controls movements in children~     with cerebral palsy. Normally, one side of the brain controls movements in the opposite side~     of the body. In cerebral palsy, however, this pattern may be different, with one side of the~     brain controlling movements on the same side of the body. This study will use magnetic~     resonance imaging (MRI) and transcranial magnetic stimulation (TMS) to study brain function~     in children with cerebral palsy before and after therapy.~      Children between 9 and 17 years of age with spastic hemiplegia type cerebral palsy will be~     recruited for this study from the National Rehabilitation Hospital and Georgetown University~     Center Medical Center in Washington, D.C., and the Sparks Center at UAB in Alabama. In~     addition, five healthy control children will be recruited from community groups, such as Cub~     Scouts, Brownies, and schools. Candidates are screened with a review of medical records and~     neurological and physical examinations.~      Healthy controls undergo MRI (described below) twice, 3 weeks apart. Children with cerebral~     palsy undergo the following tests and procedures:~        1. Rehabilitation evaluation at the NIH Clinical Center Rehabilitation Medicine Department.~        2. MRI: For this test, the child lies on a table that slides in and out of the MRI~          scanner-a metal cylinder surrounded by a strong magnetic field. He or she wears earplugs~          to muffle loud knocking sounds that occur during scanning. Images are obtained while the~          child performs simple finger tapping movements.~        3. Movement Testing:~             1. Finger tapping: The child taps buttons on a box hooked up to a computer~             2. Muscle reflex measurements: One method uses a small motor that makes the child's~               fingers move with sudden, small movements; a second method uses small shocks to the~               finger or wrist. The shocks feel like a buzz; most are gentle, but some might feel~               stronger.~        4. TMS: This procedure maps brain function. A wire coil is held on the scalp, and a brief~          electrical current is passed through the coil, creating a magnetic pulse that stimulates~          the brain. During the stimulation, the child may be asked to perform simple movements..~          The stimulation may cause a twitch in muscles of the face, arm, or leg, and the child~          may hear a click and feel a pulling sensation on the skin under the coil.~        5. Therapy: After these tests, children are randomly selected to receive either standard~          therapy (neurodevelopmental treatment) or constraint-induced therapy, as follows:~             1. Neurodevelopmental therapy uses principles of movement science to enhance the~               child's capacity to function. The child receives therapy a few times a week for 3~               weeks.~             2. Constraint-induced therapy uses a combination of motor learning method and~               constraint to teach the new motor skills in the child's affected hand. Children~               treated with this therapy must live near a special treatment center in Alabama for~               the 3 weeks of treatment. The child's good arm is constrained with a bivalve,~               removable cast. The cast is placed before therapy starts and remains in place~               except when the therapist removes it once a day to examine the good arm. With the~               cast on, children are encouraged to use their affected hand in new ways. The~               therapist then uses the motor learning method, building motor programs as a result~               of practice, to teach them new skills. Motor learning therapy is 6 hours a day.~        6. Post-treatment testing: After treatment, children undergo repeat rehabilitation~          assessment, MRI, TMS, and movement testing.~   "
263442|NCT00100490|"~     This is a study investigating immune function and relationships to the~     hypothalamic-pituitary-adrenal (HPA) axis in Post-traumatic stress disorder (PTSD) compared~     to controls without PTSD. The study involves 99 adult veterans and civilian subjects over a 3~     year period. The study involves measuring immune and neuroendocrine parameters from blood~     samples obtained before and after a dexamethasone suppression test. The aim of the study is~     to determine whether immune alterations exist in PTSD and whether the immune-HPA axis~     interactions in this disorder are different from non-PTSD subjects with the future aim of~     studying whether immune dysregulation in PTSD may be linked to the increased risk for medical~     and psychiatric comorbidity in this population.~   "
263443|NCT00100477|"~     The purpose of this study is to identify the highest tolerated doses in drugs used to treat~     aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy~     treatment. The drugs being used in this study include drugs frequently used in treating such~     diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be~     effective (topotecan).~   "
263444|NCT00100464|"~     The purpose of this study is to determine if a certain medication, alone or combined with~     another medication, will increase muscle activity in the upper airway in people who do and~     people who do not have sleep apnea. The medications being studied are paroxetine, a commonly~     used antidepressant, and 5 hydroxy-tryptophan (5HTP), which also can be used as a dietary~     supplement without a prescription. Because the effects of paroxetine in previous studies were~     not very large, we will also study it combined with 5HTP to see if the effect on the upper~     airway muscles is greater.~   "
263445|NCT00100451|"~     The purpose of this study is to determine whether exercise alters the way in which the body~     stores and breaks down fat. A second objective is to evaluate how these effects are~     influenced by your age and gender. These studies are important because aging, male gender,~     and menopause are associated with an increased storage of abdominal fat which is frequently~     accompanied by diabetes, a high blood cholesterol level, high blood pressure and greater~     risks of heart attack, stroke, and death. Increasing evidence suggests that these~     abnormalities and many other effects of aging may be partly due to lack of exercise.~   "
263446|NCT00100438|"~     This is a database study. Medical records will be reviewed in order to document a new or~     pending diagnosis of Parkinson's disease and in order to learn more about the disease~     process. Other than the time that it takes to complete a medical record authorization form,~     no other human subject participation will be needed.~   "
263447|NCT00100425|"~     The purpose of this study is to provide new information and to determine which kinds of~     brief, tolerable, experimental pain are affected by the drugs being studied in patients with~     irritable bowel syndrome, a disease that causes chronic abdominal pain. The effects of~     dextromethorphan, naloxone, and fentanyl on experimental pain stimuli will be tested in these~     studies to better understand what causes irritable bowel syndrome.~   "
263460|NCT00100256|"~     The purpose of this study is to determine the maximum dose that is safely tolerated of the~     experimental drug Rhenium Re 188 P2045. This will be done by first treating patients at~     relatively low doses of Rhenium Re 188 P2045, observing them closely to assure that there are~     no bad side effects, then increasing the dose when we are confident that it is safe to do so.~   "
263461|NCT00100243|"~     This is a Phase 2, open-label study in subjects with androgen-independent prostate cancer who~     have progressed following treatment with an LHRH agonist. Up to 22 subjects will be enrolled.~     Enrollment will be monitored to ensure that not all subjects are enrolled based on rising~     prostate specific antigen (PSA) criterion only.~      Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks~     for 12 weeks (total dose of 600 mg).~   "
263448|NCT00100412|"~     This research project is a follow-up to the prior VA-funded study that found that chronic~     fatigue reported by many Gulf War veterans may be a symptom of dysfunctional cardiovascular~     stress response regulation. Specifically, ill veterans had diminished autonomic responses~     during demanding psychosocial tasks involving high level cognitive processing and emotional~     stress. There was a close relationship between clinical status of ill veterans and their~     inability to mount an appropriate physiological response under stress. The main objective of~     the present investigation is to determine the specific mechanism through which this~     abnormality may contribute to Gulf War-related chronic fatigue. We also observed that Gulf~     veterans with posttraumatic stress disorder (PTSD) had the most dampened autonomic activation~     to stressors involving higher brain activities. The second major focus of this study is to~     explore the role of a psychiatric disorder, specifically PTSD, as a factor in abnormalities~     in stress response regulation. This aspect of the study may also provide pertinent~     information as to the role of stress of military deployment as a contributing factor in~     post-Gulf War illnesses.~   "
263449|NCT00100399|"~     The purpose of this study is to test the immune response caused by investigational Fluarix~     vaccine in healthy people aged between 18-64 years in the U.S.A. Up to 1050 volunteers at 4~     centers will receive Fluarix or Placebo (saline), and their responses will then be compared.~     Subjects will be placed by age into 2 groups (18 to 49 years old and 50 to 64 years old),~     then randomly assigned to receive a dose of Fluarix or Placebo by injection into a muscle.~     There will be 2 phases in this study: (1) the active study phase (2 visits) for all subjects;~     and (2) the cross-over phase, only for subjects enrolled in the placebo group who accept to~     receive Fluarix. Blood samples will be obtained in order to measure immune response to the~     vaccine. On the day of vaccination, volunteers will receive a diary card to record~     information on symptoms experienced during the next 3 days. Subject participation in either~     group will be up to 2 months.~   "
263450|NCT00100386|"~     Primary Outcome Measures:Incidence density of colonization with MRSA or VRE (number of new~     colonization events per 1000 patient days at risk) during the intervention phase. Secondary~     Outcome Measures:The effect of the 2 strategies on the incidence density of colonization with~     MRSA and VRE individually will be determined and compared descriptively. The effect of the~     strategies on the cumulative incidence of bacteremia caused by MRSA and VRE will be~     determined to assess the clinical relevance of the strategy in preventing infection. The~     trial will evaluate the frequency of hand hygiene and the use of gloves and gowns by~     healthcare workers to substantiate whether the effect of the intensive control strategy is~     mediated, as expected, by an increase in the use of gloves and gowns due to an increase in~     the number of patients cared for using Contact Precautions.~   "
263451|NCT00100373|"~     The purpose of this study is to measure the immune response (how the body fights infection)~     to an experimental preparation of live Respiratory Syncytial Virus (RSV). A better~     understanding of this virus may be useful in development of vaccines and treatments.~     Participants will include 20 healthy adults age 21-40. Study procedures will include drawing~     blood, urine samples, respiratory exams, vital signs and temperature, diary cards, nasal~     mucus weight and nasal washes and swabs. All participants will receive vaccine via nose~     drops. Patients will participate in the study for about 2 months.~   "
263452|NCT00100360|"~     This study will explore possible hormonal causes of menstrual-related mood disorders (MRMD)~     by stopping the menstrual cycle with a drug called Lupron and then giving in sequence two~     menstrual cycle hormones, progesterone and estrogen. The study will first evaluate Lupron's~     effectiveness in treating MRMD and will then examine the effects of giving estrogen and~     progesterone on mood and behavior. In addition, positron emission tomography (PET) and~     magnetic resonance imaging (MRI) will be used to study serotonin receptors and transporters -~     molecules in the brain that are thought to play a major role in mood changes related to the~     menstrual cycle.~      Menstruating women between 18 and 50 years of age who are in good health, not pregnant, and~     not taking medications may be eligible for this study. Women with MRMD must have had at least~     moderately severe MRMD or behavioral disturbances for at least 6 months within 2 years of~     entering the study. Healthy controls must have no history of MRMD or behavioral disturbances.~     Candidates undergo physical and neurological examinations, chest x-ray, electrocardiogram,~     and blood and urine tests. Results of a recent Pap smear (no longer than 12 months before~     beginning the study) must be available.~      Participants undergo the following tests and procedures:~        -  Drug treatment: Lupron is injected into a muscle once a month for 5 months. After the~          second month, participants receive estrogen or progesterone, or both, daily. Estrogen is~          delivered through a skin patch (20 micrograms per day) and the progesterone is taken as~          a rectal or vaginal suppository twice a day for the remaining 12 weeks of the study.~          Every day, all participants wear a skin patch and insert two suppositories, but at some~          point during the 12 weeks, active medication is replaced with placebo to allow the drugs~          to wash out of the body.~        -  Physical examination and blood draw: A physical examination and blood tests are done at~          the start of the study and several times during the study to assess general health,~          evaluate liver and kidney function, and measure blood cell counts.~        -  Response to treatment drugs: Responses to Lupron, estrogen, and progesterone are~          evaluated periodically with interviews and symptoms self-rating scales. Control subjects~          also take paper and pencil psychological tests.~        -  PET imaging: A total of six PET scans are done at three time points during hormone~          treatment. PET uses small amounts of a radioactive chemical called a tracer that~          labels active areas of the brain. For the procedure, the subject lies on the scanner~          bed. A special mask is fitted to the head and attached to the bed to help keep the~          subject's head still during the scan so the images will be clear. A brief scan is done~          just before the radioactive tracer is injected to help in analyzing the PET data. After~          the tracer is injected through a catheter (plastic tube) placed in the arm, pictures are~          taken for about 2 hours, during which the subject lies still on the scanner bed.~        -  MRI scan: MRI uses a magnetic field and radio waves to produce images of body tissues~          and organs. For this procedure, the patient lies on a table that is moved into the~          scanner (a narrow cylinder) and wears earplugs to muffle loud knocking and thumping~          sounds that occur during the scanning process. The procedure lasts about 1 hour.~   "
263453|NCT00100347|"~     The purpose of this multi-center, open-label, escalating dose study is to assess the safety~     and tolerability of PPI-2458 in subjects with Non-Hodgkin's Lymphoma (NHL)and solid tumors.~     Subjects will be treated every other day (QOD) with PPI-2458 while being monitored closely~     for adverse events.~   "
263454|NCT00100334|"~     This is a single-center, double-blind, inpatient study followed by an outpatient,~     placebo-controlled, multiple-IV injection evaluation of the safety and tolerability of~     PPI-1019 in subjects with mild-moderate Alzheimer’s disease (AD). The primary objective of~     the study is to assess the safety of multiple IV injections of PPI-1019 in subjects with~     mild-moderate Alzheimer’s disease.~   "
263455|NCT00100321|"~     This study will examine pancreatic tumor tissue and immune cells from patients with a~     pancreatic tumor to look for markers on these cells that may be useful in developing new~     treatments for the disease.~      Patients 16 years of age and older with any evidence of a primary pancreatic tumor that can~     be surgically removed may be eligible for this study. Types of pancreatic tumors included in~     this trial are pancreatic cancer, adenosquamous carcinoma, anaplastic carcinoma, IPMN~     (intraductal pancreatic mucinous neoplasm), acinar cell carcinoma, pancreaticoblastoma,~     mucinous cystic neoplasms, serous cystic neoplasms, solid-pseudopapillary cystic neoplasms,~     squamous cell carcinoma, Vater (ampullary tumors) duodenal adenoma or cancer and common bile~     duct tumors (cholangiocarcinoma.) The specific type of tumor does not have to be determined~     before the operation. Candidates are screened with a medical history and physical~     examination, computed tomography (CT) or magnetic resonance imaging (MRI) of the chest,~     abdomen, and pelvis, blood and urine tests, and an electrocardiogram. Patients older than 50~     years of age and patients with a history of cardiovascular disease may also have a thallium~     cardiac stress test.~      Participants undergo standard treatment for their pancreatic tumor, including surgery to~     remove the tumor. Before, during, and after the operation, several blood samples are drawn as~     part of routine patient care and for research tests. During the surgery, a small piece of~     tumor tissue is taken for examination under the microscope and to grow cells in the~     laboratory for tumor and immune cell studies. Some patients may undergo leukapheresis to~     collect large numbers of white blood cells for study. For this procedure, blood is collected~     through a needle in an arm vein and flows through a catheter (plastic tube) into a machine~     that separates it into its components by centrifugation (spinning). The white cells are~     extracted and the rest of the blood (plasma, red cells, and platelets) is returned through~     another needle in the other arm.~      Patients who require additional treatment, such as chemotherapy or radiation, may be treated~     at NIH on another protocol or referred for appropriate treatment elsewhere.~   "
263456|NCT00100308|"~     The purpose of this study is to determine whether low dose continuous infusion of~     unfractioned heparin (500 units/hour), in addition to the standard treatment, is efficacious~     as complementary therapy for sepsis patients.~   "
263457|NCT00100295|"~     The purpose of this study is to determine the safety and effectiveness of an herbal product~     for the treatment of attention deficit hyperactivity disorder (ADHD) in children and~     adolescents.~   "
263458|NCT00100282|"~     This is a multi-center, double-blind, inpatient study followed by outpatient,~     placebo-controlled, single-dose, dose-escalation evaluation of the safety and tolerability of~     PPI-1019 in patients with mild-moderate Alzheimer’s disease (AD). Up to 12 sequential cohorts~     of 8 patients (6 active and 2 placebo) will be given a single PPI-1019 dose intravenously~     (IV) over 1 minute in order to determine a maximum tolerated dose (MTD). The MTD will be the~     dose immediately below the not-tolerated dose.~   "
263459|NCT00100269|"~     Oxidative stress related damage to sperm is believed to be a major cause of male infertility.~     The object of the Menevit study is to investigate the role of a novel anti-oxidant~     preparation (Menevit) on sperm function, embryo quality and pregnancy rates in an in vitro~     fertilization (IVF) setting.~   "
263462|NCT00100230|"~     Purpose:~      Retinitis pigmentosa (RP) is characterized by progressive loss of visual function due to~     specific genetic mutations. This trial is focused on patients with one of the most severe~     forms of the disease, X-linked inherited RP (XLRP). This disease is characterized by early~     onset (typically loss of night vision as a child) followed by loss of peripheral vision as a~     teenager and young adult. There is no male-to-male transmission of the disease in the family.~      There is no cure for RP and treatment options are limited. Two clinical trials have not found~     a benefit from nutritional supplementation with the long-chain polyunsaturated fatty acid,~     docosahexaenoic acid (DHA), at low daily doses although there is evidence that it slows~     disease progression in certain instances. In this clinical trial, we propose that a high dose~     nutritional DHA supplement will slow the loss of visual function and preserve usable vision~     in patients with XLRP.~      This study is a 4-year placebo-controlled randomized clinical trial meaning that patients~     have a 50-50 chance of receiving placebo or experimental treatment. A total of 66 patients~     will be enrolled; 33 will receive placebo and 33 will receive the treatment. Entry criteria~     include diagnosis of XLRP by an ophthalmologist, age 7 to 32 years, male, sufficient visual~     function such that disease progression can be followed for the entire duration of the trial,~     and a willingness to visit the testing site (Dallas, TX) once a year.~      Annual visual function testing includes ETDRS visual acuity, full-field and multifocal~     electroretinography (ERG), static peripheral visual fields, and fundus photography. Cone ERG~     function is the primary outcome measure.~      Funding Source - FDA, Foundation Fighting Blindness, DSM Nutritionals~   "
263463|NCT00100217|"~     This study provides training opportunities for critical care specialists in evaluating and~     treating critically ill patients. Patients enrolled in the study receive standard tests and~     treatments. The study objectives are to:~        -  Provide additional training for staff of the NIH Clinical Center intensive care unit,~          including physicians, nurses, fellows, and other trainees so that they develop and~          maintain essential skills,~        -  Gather information about the natural history and outcomes of critical illness,~          accompanying conditions, and complications,~        -  Develop hypotheses about the medical problems involved in the illnesses and their~          treatment, and~        -  Identify critically ill patients who may be eligible for specific NIH research~          protocols.~      Critically ill patients 18 years of age and older who may benefit by transferring to the NIH~     Clinical Center for treatment may be eligible for this study. Patients will be transferred to~     the Clinical Center from another hospital only when the referring and accepting physicians in~     both institutions agree that the potential benefit of coming to the NIH outweighs the risk of~     transferring the patient.~      Participants are evaluated and treated at the Clinical Center. Patients provide a medical~     history and have a physical examination. They may also have various medical tests and~     procedures needed to evaluate their condition. These procedures may include blood work,~     placement of an intravenous (IV) line, x-rays and other imaging tests such as computed~     tomography (CT) or magnetic resonance imaging (MRI) and other procedures.~      Patients who are diagnosed with a specific condition may be offered treatment or may be~     referred to another study that is more appropriate for that particular problem.~   "
263464|NCT00100204|"~     This study will examine saliva samples from healthy volunteers and patients with various~     diseases to learn more about how disease affects the mouth and salivary glands. It will use a~     method called salivary proteomics to identify multiple proteins in saliva and discover if~     there are protein patterns unique to specific diseases. The study will:~        -  Characterize the salivary proteome in patients with Sjogren's syndrome,~          graft-versus-host disease, diabetes, sarcoidosis, cystinosis, dental caries, and~          immunodeficiencies and in patients who have had head and neck radiation~        -  Evaluate the possible use of salivary proteomics for early diagnosis~        -  Evaluate the potential use of salivary proteomics for prognosis and treatment~      Patients participating in NIH clinical studies who have Sjogren's syndrome, graft-versus-host~     disease, diabetes, sarcoidosis, cystinosis, dental caries, or an immunodeficiency, or~     patients undergoing head and neck radiation may be eligible for this study. Candidates are~     screened with a medical and dental history, head and neck examination, and photographs of any~     mouth sores or disease. Healthy volunteers also have blood drawn for routine laboratory~     testing.~      Participants have saliva collected from the floor of the mouth, the parotid salivary glands~     in the cheek, and the submandibular and sublingual salivary glands under the tongue. Patients~     with certain diseases also provide a urine sample. Saliva samples are collected as follows:~        -  One time from healthy volunteers and patients with Sjogren's syndrome, diabetes,~          sarcoidosis, cystinosis and immunodeficiencies~        -  Five times from patients undergoing stem cell transplant: at baseline before transplant~          and about 1, 2, 3 and 6 months after transplant.~        -  Three times from patients undergoing head and neck radiation: at baseline before~          radiation and at 3 and 6 months after the conclusion of radiation.~   "
263465|NCT00100191|"~     The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization~     (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE~     was considered equivalent to hysterectomy when at least 75% of patients had normalization of~     heavy menstrual blood loss after treatment.~   "
263466|NCT00100178|"~     The objective of this study is to identify immune intervention strategies that will preserve~     residual beta cell function at the onset of type 1 diabetes. Scientific evidence developed~     over the last 10 - 20 years suggests that type 1 diabetes is a chronic, slowly progressive~     autoimmune disease and that clinical symptoms do not develop until at least 80% - 90% of beta~     cell mass has been destroyed as a result of the autoimmune process. It is now recognized that~     preservation of remaining beta cells is clinically important as the ability to secrete, even~     small amounts of insulin, can make the disease easier to control and help minimize~     complications associated with having years of inadequate glycemic control.~      This clinical trial is the first in a series of studies to be launched by the TrialNet Study~     Group to test various interventions for preserving residual beta cell function in new onset~     type 1 diabetes. Specifically, this study is designed to determine the ability of~     Mycophenolate Mofetil (MMF/CellCept) used alone, or in combination with Daclizumab~     (DZB/Zenapax) to see if it is possible to stop the immune system from destroying beta cells~     in new onset type 1 diabetes patients (within 3 months of diagnosis.)~      Researchers have made great strides in understanding how the immune system works and in~     changing the activity of immune cells with medicines called immunotherapies. Some~     immunotherapies work by making the immune system less active. Scientists have discovered that~     key immune cells, called T cells, help to cause type 1 diabetes. These T cells are largely~     responsible for attacking the beta cells that produce insulin. Doctors have found medicines~     that slow or suppress the activity of T cells. It is hoped that these immunosuppressive~     medicines can help treat type 1 diabetes by stopping T cells before they destroy all of the~     beta cells.~      Medicines that make the immune system less active have been developed and studied for other~     diseases. Mycophenolate mofetil (MMF) and Daclizumab (DZB) are two of these medicines. Their~     effects on the immune system are well understood. Researchers believe these medicines may~     lessen the immune system's destruction of beta cells that leads to type 1 diabetes. In~     addition, researchers hope the effect of these medicines will last longer than other~     therapies.~      The goal of this study is to find out if two medicines are able to stop the ongoing~     destruction of beta cells which are still functioning at the time type 1 diabetes is~     diagnosed. The two immunosuppressive medications being tested are Mycophenolate mofetil~     (MMF/CellCept®) and Daclizumab (DZB/Zenapax®). They work by making the immune system less~     active. TrialNet researchers hope that these medications will help maintain insulin secretion~     from remaining beta cells and thus help to maintain better glycemic control. Even if the~     medications work, study participants will still need to take insulin injections but it may~     make it easier to control normal blood sugar levels which can help reduce long-term~     complications of diabetes such as blindness, kidney failure, nerve damage, heart attack and~     stroke.~      The aim is to arrest beta cell destruction in newly diabetic subjects because immune~     modulation may not work well alone once the autoimmune process has progressed to complete or~     near complete destruction of beta cells. The study's rationale is to demonstrate a meaningful~     preservation of islet function with minimal immune system side effects over the 4-year course~     of this study.~      The data from this clinical trial could serve as the basis for a larger trial if the results~     are sufficiently positive, or they could suggest other combined intervention trials that~     might achieve either better efficacy or potentially preserve C-peptide without the need for~     continued immunosuppression.~   "
263467|NCT00100165|"~     The study hypothesis is that 3-2,4 dimethoxybenzylidene anabaseine (DMXB-A), an orally~     administered nicotinic cholinergic agonist, will improve attention and other~     neuropsychological dysfunctions in schizophrenia, leading to improved psychosocial outcome.~   "
263468|NCT00100152|"~     A Notch signalling pathway inhibitor study in pediatric and adult patients with relapsed~     (worsening) or refractory (not responding to treatment) T-cell acute lymphoblastic~     leukemia/lymphoma (T-ALL).~   "
263469|NCT00100139|"~     In this study, Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is being compared to~     Taxol® to examine whether the paclitaxel in these 2 formulations undergoes similar processing~     by the body. Safety and tolerability of LEP-ETU and Taxol will also be assessed. In this~     study, each patient will receive one intravenous infusion of LEP-ETU or Taxol, followed 3~     weeks later by an infusion of the other drug, at the same dose and infusion duration.~     Multiple blood samples will be taken for analysis before, during, and after both drug~     infusions. Upon completing these 2 Cycles of treatment, eligible patients may enroll in an~     extension study (LEP-ETU-102B) to continue treatment with LEP-ETU.~      LEP-ETU is a liposomal formulation of paclitaxel, a widely used anti-cancer drug. This~     LEP-ETU formulation of paclitaxel is being developed to potentially reduce toxicities~     associated with Taxol, by eliminating the drug formulation component polyoxyethylated castor~     oil (Cremophor® EL). In LEP-ETU, paclitaxel is associated with liposomes, which are~     microscopic membrane-like structures created from lipids (fats). Thus, the LEP-ETU~     formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy.~   "
263470|NCT00100126|"~     The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in~     the bacteriological outcome at the Test of Cure Visit.~   "
263471|NCT00100113|"~     The purpose of this study is to assess potential interactions between intravenous (IV)~     cocaine and 3 doses of GBR 12909.~   "
263479|NCT00099996|"~     This study will test the safety and effectiveness of 40 mg of ezetimibe (Zetia ) daily in~     lowering blood levels of cholesterol and of the plant sterols sitosterol and campesterol in~     patients with homozygous sitosterolemia, an inherited disorder of sterol metabolism. (Sterols~     are alcohol substances found in animal and plant fats.) In this disorder, an excess of many~     plant sterols is absorbed and not enough excreted. Patients can develop atherosclerosis and~     coronary heart disease as early as childhood, as well as other problems including arthritis,~     arthralgia, and tendon xanthomas (lipid deposits). Current treatment consists of ezetimibe 10~     mg, dietary restriction of plant and shellfish sterols, and bile salt binding resins.~     Ezetimibe is a cholesterol-lowering drug that inhibits intestinal absorption of cholesterol~     and structurally related plant sterols across the intestinal wall.~      Patients with homozygous sitosterolemia who are between 18 and 85 years of age have completed~     NHLBI's 1-year study of ezetimibe at 10 mg a day may be eligible for this study.~      All participants maintain their current stable diet and take a 10-mg pill of ezetimibe daily~     for 26 weeks. They are also randomly selected to take either an additional 30-mg pill of~     ezetimibe or a placebo (look-alike pill with no active ingredients). Patients fast for at~     least 12 hours before each of 6 visits scheduled during the course of the study. At these~     visits, patients undergo some or all of the following procedures for monitoring their health~     and evaluating their response to treatment:~        -  Medical history and review of medications~        -  Physical examination~        -  Measurement of vital signs (pulse rate, blood pressure, breathing rate and temperature)~        -  Review of dietary maintenance~        -  Measurements of height, weight, and waist circumference~        -  Measurement (with ruler) and photographs of non-Achilles xanthoma~        -  X-ray of Achilles tendon~        -  Blood draw and urine collection~        -  Pregnancy test for women of childbearing potential~   "
263480|NCT00099983|"~     The purpose of this research of 400 participants is to determine whether a drug called~     risperidone can decrease symptoms of Post-Traumatic Stress Disorder (PTSD). It is a~     placebo-controlled study, meaning that half of the participants will be assigned to receive a~     pill that contains no drug. The treatment phase of the study will last for 6 months, during~     which time participants will continue to receive all their usual treatments in addition to~     the study treatment and will be asked to complete procedures and assessments (questionnaires,~     interviews, laboratory tests, physical exams, etc.) related to their PTSD symptoms at various~     points within the 6-month treatment phase. At the end of the 6-month study, participants will~     discontinue the study treatment.~   "
263481|NCT00099970|"~     This clinical trial is being conducted to determine tumor response and preliminary safety of~     a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that~     is required for the establishment of new blood vessels during tumor growth, a process known~     as angiogenesis.~   "
263482|NCT00099957|"~     This study was not conducted in the United States. Many people with type 2 diabetes also have~     high cholesterol levels. The purpose of this study was to evaluate the effects of~     vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and~     cholesterol in people with type 2 diabetes.~   "
263483|NCT00099944|"~     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a~     single oral drug. The purpose of this study is to assess the safety and effectiveness of two~     doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when~     added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a~     sulfonylurea alone.~   "
263484|NCT00099931|"~     Many people with type 2 diabetes cannot maintain their target blood glucose levels on a~     single therapy. The purpose of this study is to assess the safety and effectiveness of~     vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to~     insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin~     alone.~   "
263485|NCT00099918|"~     The purpose of this study is to assess the safety and effectiveness of vildagliptin, an~     unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people~     with type 2 diabetes who have not previously been treated with drug therapy to lower their~     blood sugar.~   "
263486|NCT00099905|"~     The purpose of this study is to assess the safety and effectiveness of three doses of~     vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose~     levels in people with type 2 diabetes who have not been previously treated with drug therapy~     to lower their blood sugar.~   "
263487|NCT00099892|"~     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a~     single oral drug. The purpose of this study is to assess the safety and effectiveness of two~     doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2~     diabetes who are not at target blood glucose levels on metformin alone.~   "
263488|NCT00099879|"~     The purpose of this clinical research study is to learn if BMS-275183 can shrink or slow the~     growth of the cancer in subjects with non-small cell lung cancer (NSCLC). The safety of this~     treatment will also be studied.~   "
263489|NCT00099866|"~     The purpose of this study is to assess the safety and effectiveness of vildagliptin, an~     unapproved drug, compared to metformin in lowering overall blood glucose levels in people~     with type 2 diabetes who have not been previously treated with drug therapy to lower their~     blood sugar.~   "
263490|NCT00099853|"~     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a~     single oral drug. The purpose of this study is to assess the safety and effectiveness of~     vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to~     pioglitazone in people with type 2 diabetes not at target blood glucose levels on either~     pioglitazone or rosiglitazone alone.~   "
263500|NCT00099723|"~     Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the~     liver. It is the most common cause of chronic liver disease in the United States. The exact~     cause of NAFLD is unknown, but it is more common among people with conditions such as~     adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults~     between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a~     chain of biological processes that stress the liver, causing liver inflammation. Probiotics,~     living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial~     overgrowth and/or strengthening the gut walls. Because probiotics are generally safe,~     inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.~   "
263501|NCT00099710|"~     The purpose of this study is to examine the safety and tolerability of curcumin, and to~     determine its effect on patients with mild to moderate Alzheimer's Disease (AD).~   "
263502|NCT00099697|"~     The purpose of this study is to determine whether DHEA replacement therapy decreases~     abdominal fat and improves insulin sensitivity.~   "
263633|NCT00097825|"~     The goal of this study is to determine the effectiveness and safety of an annual intravenous~     treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will~     receive calcium and vitamin D supplements.~   "
263491|NCT00099840|"~     Acute respiratory tract infections (ARTI) are among the most frequent reasons for seeking~     medical attention in primary care. Although from predominantly viral origin, ARTIs are the~     most important condition for the prescription of antibiotics (AB), mainly due to the~     difficulty in primary care to differentiate between viral and bacterial etiology. Unnecessary~     AB use increases drug expenditures, side effects and AB resistance. A novel approach is to~     guide AB use by procalcitonin (ProCT), since serum levels are elevated in bacterial~     infections but remain lower in viral infections and inflammatory diseases.~      We aim to compare a strategy based on evidence-based guidelines with ProCT guided AB therapy~     in ARTIs with respect to outcome (days with restriction) and AB use. Patients presenting with~     ARTIs to primary care physicians and are intended to be treated with AB based on guidelines~     will be included and randomized 1:1 either to standard management or to the ProCT guided~     prescription of AB. All participating physicians will receive evidence-based guidelines for~     the management of patients with ARTIs. Patients with ARTI and in need of ABs by physicians’~     clinical judgment and with informed consent will be randomized to ProCT plus guidelines~     (ProCT group) versus only guidelines guided AB treatment (control group). In patients~     randomized to the ProCT group, the use of antibiotics will be more or less discouraged (<0.1~     or <0.25 ug/L) or encouraged (>0.5 or >0.25 ug/L), respectively. A re-evaluation in patients~     with ProCT (<0.1 or <0.25 ug/L) after 6 to 24 hours is mandatory. All patients will be~     reassessed at day 3 and it is recommended to stop AB in the ProCT group as described above.~     Structured phone interviews at days 14 and 28 will be done in all patients from both groups.~   "
263492|NCT00099827|"~     The main objective of this research project is to describe the impact of depression on~     adolescent and family functioning compared to that of healthy adolescents and to understand~     the impact of Feedback and Patient Activation (FPA) on teen and family decision-making~     regarding seeking care for depressive disorders.~   "
263493|NCT00099814|"~     Orthodontic treatment requires application of force systems to individual teeth or groups of~     teeth, which results in a cellular response with periodontal ligament (PDL) and alveolar bone~     remodeling. The forces applied must be of sufficient magnitude and duration to exceed the~     normal physiologic threshold associated with daily oral function. Excessive force levels will~     result in areas of tissue necrosis with delayed tooth movement and increased risk of root~     resorption. Although orthodontic tooth movement is achieved in a large segment of the~     population, the optimum force level has not been defined. The optimum force for tooth~     movement depends on individual root geometry as well as biologic characteristics of~     surrounding tissue including bone density, periodontal thickness, and fluid dynamics.~      Because experimental and clinical techniques are generally limited to known complex force~     systems, biomechanical modeling has become a necessity. Such models must be validated with~     well-controlled clinical studies that evaluate orthodontic tooth movement over an extended~     distance. The ultimate goal would be development of a computer simulation model to predict~     tooth movement in the clinical setting.~      The primary objective of this study is to test controlled clinical data with a biomechanical~     model of the tooth and supporting tissues for distal movement of the human maxillary canine~     tooth (of known root geometry) in response to various 3D force systems that produce different~     levels of stress in the supporting tissues. Secondary objectives include evaluation of rate~     of bodily tooth canine movement with two known compressive stress levels (13 and 22 kPa),~     evaluation of three different reference systems to measure rate of tooth movement, and~     evaluation of an implant placed in the roof of the mouth (palatal implant) for orthodontic~     anchorage in adolescent patients.~      The rate of translation (bodily) tooth movement of the maxillary canine tooth will be~     significantly greater with 22kPa compared to 13kPa compressive stress applied to the~     periodontal ligament, and this difference can be predicted by appropriate~     mathematical/numerical models of the tooth and supporting tissues.~   "
263494|NCT00099801|"~     The safety and efficacy of FTY720 is being evaluated in patients who receive a kidney~     transplant.~   "
263495|NCT00099788|"~     MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled,~     parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine~     during acute and long-term treatment in approximately 5,500 patients with non-ST elevation~     acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint~     in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of~     cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST~     elevation ACS receiving standard therapy. The study also evaluates the safety of long-term~     treatment with ranolazine compared to placebo.~   "
263496|NCT00099775|"~     This study will examine whether the anti-fungal drug caspofungin can prevent Candida~     infections in adult patients in intensive care units (ICUs). Caspofungin is approved to treat~     certain fungal infections, including fungal blood stream infections due to Candida. Because~     ICU patients are at high risk for Candida, it would be beneficial to have a preventive drug,~     thereby reducing complications due to infection.~      Patients 18 years of age or older who are not pregnant may be enrolled in this study on day 3~     or 4 of their ICU admission if they have an expected stay of at least 2 additional days in~     the ICU.~      Participants are randomly assigned to treatment with either caspofungin or placebo (an~     inactive substance). Before treatment, patients have a medical history and physical~     examination. Blood and urine tests are done for routine tests and to look for fungal~     infection. Additional samples that may be collected to test for fungal infection include a~     rectal swab or stool sample; a wound culture if the patient has a wound, or a sputum culture~     in patients who have a tube in their throat to help with breathing or are producing sputum.~      Patients take caspofungin or placebo once a day for no more than 28 days. In addition, they~     undergo the following procedures:~        -  Review of treatment side effects and medicines taken, daily during treatment, 1 week~          after treatment, and 2 weeks after treatment~        -  Physical examination once a week, on the last day of treatment, and 1 week after~          treatment~        -  Urine test once a week, on the last day of treatment, and 1 week after treatment to look~          for possible fungal infection~        -  Blood tests twice a week, on the last day of treatment, 1 week after treatment, and 2~          weeks after treatment for laboratory safety tests and to look for fungal infection~        -  Collection of additional samples (rectal swab or stool sample, wound culture, or sputum~          sample) once a week, on the last day of treatment, and 1 week after treatment to look~          for possible fungal infection~   "
263497|NCT00099762|"~     This study will use a procedure called selective venous catheterization in patients with~     tumor-induced osteomalacia (TIO) or oncogenic osteomalacia (OOM) to try to locate very small~     tumors that produce proteins called phosphatonins. Too much phosphatonin in the blood causes~     the kidneys to allow large amounts of phosphorus to be excreted in the urine, leading to low~     blood levels of phosphorus and, in turn, to osteomalacia (a condition of soft bones).~     Osteomalacia can cause bone fractures requiring many surgical procedures that can leave~     patients in pain. Patients may also feel weak and can lose height from massive bone loss.~     Selective venous catheterization is a way to measure the amount of phosphatonin in the blood~     and may be used as a way to locate phosphatonin-producing tumors that cannot be found using~     standard imaging techniques.~      Patients with TIO or OOM are screened under NIDR Protocol 01-D-0184 with a medical history,~     review of medical records and routine physical examination. Other procedures may include~     blood tests, urine tests, and imaging tests, such as x-rays, bone densitometry, bone scan,~     computed tomography (CT) and magnetic resonance imaging (MRI). This study will include mostly~     patients whose tumors were not able to be located through imaging procedures, but also a few~     patients whose tumors were located.~      All participants, regardless of whether or not their tumor was located, undergo selective~     venous catheterization. For this procedure, a radiologist inserts a catheter (thin flexible~     tube) into the body and uses fluoroscopy (a type of x-ray) to guide the tip of the catheter~     to different places in the body to collect small amounts of blood from the different areas.~     After the procedure, the patient lies flat for 2 hours and avoids moving his or her leg on~     the side where the catheter was placed.~      The blood is analyzed to measure the amount phosphatonin is in each sample, and the amounts~     are compared to the average amount of phosphatonin in the general blood circulation. If a~     higher level of phosphatonin is found in one area and the location of the tumor is unknown,~     the patient undergoes imaging in that area. If a tumor is found and it is in an area where it~     can be removed surgically, the patient is given the option to have the surgery. If the tumor~     is not found by imaging done after the first catheterization procedure, the patient has the~     option to have a second catheterization, taking samples of blood only from the area where the~     phosphatonin was found to be the highest during the sampling procedure.~   "
263498|NCT00099749|"~     The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney~     transplant.~   "
263499|NCT00099736|"~     The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney~     transplant.~   "
263503|NCT00099684|"~     Anti-HIV drugs, especially protease inhibitors (PIs), have been linked to lipid metabolism~     problems, including elevations in low density lipoprotein cholesterol (LDL-c), triglycerides,~     and total cholesterol. Ezetimibe is a lipid-controlling drug; statins are part of another~     class of lipid-lowering drugs popularly prescribed to people with high cholesterol. The~     purpose of this study is to determine the safety, effectiveness, and tolerability of~     ezetimibe in combination with statin therapy in adults who are taking anti-HIV drugs and have~     high cholesterol.~      Study hypothesis: In HIV infected adults, ezetimibe in combination with statin therapy will~     result in significantly lower LDL-c compared to statin therapy alone.~   "
263504|NCT00099671|"~     The purpose of this study is to determine the safety of a single, under-the-skin dose of~     interleukin-7 (IL-7) in HIV infected people currently taking anti-HIV drugs.~   "
263505|NCT00099658|"~     Infection by Streptococcal pneumoniae is a common invasive bacterial infection in HIV~     infected children. The purpose of this study is to determine the safety of and immune~     response to a pneumococcal polysaccharide-protein conjugate vaccine (PncCV) in HIV infected~     and uninfected children. The study will also determine the safety of and immune response to~     Haemophilus influenzae vaccine (HibCV) in these children. Recruitment for this study will~     occur at two hospitals in South Africa, and all HIV infected infants participating in this~     study must also be coenrolled in the CIPRA SA-Project 2 study.~   "
263506|NCT00099645|"~     The purpose of this study is to determine the anti-HIV activity and safety of 3 different~     doses of mifepristone (also known as VGX-410 and RU486) in HIV infected people.~      Hypothesis: Mifepristone will be generally safe (no serious adverse effects) and well~     tolerated.~   "
263507|NCT00099632|"~     HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to~     prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance~     in the mother, potentially ruling out some treatment options in the future. The purpose of~     this study is to determine which of three anti-HIV drug regimens most effectively reduces the~     development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of~     short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared.~      The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral~     therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than~     intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of~     lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or~     lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase~     inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.~   "
263508|NCT00099619|"~     This is a study with two treatment sequences and two treatment periods that will assess the~     safety and efficacy of exenatide treatment in patients with type 2 diabetes who have~     inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next~     appropriate step in diabetes treatment.~   "
263509|NCT00099606|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, effect~     of food, and continue exploratory research of BMS-354825 in patients with solid tumors not~     responding to standard treatment, or for which no effective standard treatment exists.~   "
263510|NCT00099593|"~     This research is being done to look at the safety and value of a vaccine for a cancer found~     in the blood and skin known as Cutaneous T-cell lymphoma (CTCL) and Sezary Syndrome.~      In the laboratory, researches found that special white blood cells, called dendritic cells~     (DCs), are able to stimulate the immune system (groups of cells that protect the body from~     germs and diseases) in a way that helps your body fight cancer. Autologous (from your own~     body) DCs will be prepared (mixed together) in the laboratory with your cancer cell (Sezary~     cells) to allow your DCs to pick up parts of your Sezary cells to make the vaccine for you.~   "
263511|NCT00099580|"~     This Phase 2, randomized, placebo-controlled, multicenter outpatient study is designed to~     test the safety and tolerability of AC2592 as well as examine the effect of AC2592 on oxygen~     consumption during maximal tolerated exercise in adult subjects with chronic congestive heart~     failure.~   "
263512|NCT00099567|"~     The purpose of this study is to determine if the metabolic syndrome is a risk factor for~     cognitive decline and if this association is modified by inflammation.~   "
263513|NCT00099554|"~     The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects~     achieving a good or moderate DAS28 response (EULAR28 criteria) at Week 16 with etanercept~     50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.~   "
263514|NCT00099541|"~     This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell~     lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV~     non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is~     to see if a blood test can be used to predict when cancer-related bone lesions develop. This~     trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage~     IV non-small cell lung cancer that cannot be treated by surgery.~   "
263515|NCT00099528|"~     The purpose of this study is to gain initial safety and efficacy data on the experimental~     agent REN-1654 in patients with painful post-herpetic neuralgia (PHN).~   "
263516|NCT00099515|"~     The purpose of this study is to compare intensive and standard training for human insulin~     inhalation powder in patients with type 2 diabetes.~   "
263517|NCT00099502|"~     The purpose of this study is to determine~        -  whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe,~          tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms~        -  whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more~          efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg~   "
263518|NCT00099489|"~     The purpose of this study is to determine whether AVONEX (Interferon Beta-1a), when compared~     to placebo, reduces the total dose of IVIg that is administered after Visit 5 and through~     Visit 9 (Week 32, End of Study).~   "
263530|NCT00099320|"~     This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic~     (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured~     by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate~     glycemic control with OAD alone.~   "
275368|NCT00000286|"~     The purpose of this study is to determine the effects of nefazedone on cocaine~     self-administration in depressed and non-depressed female cocaine users.~   "
263519|NCT00099476|"~     This study will examine whether dark chocolate affects the way patients with hypertension~     (high blood pressure) respond to insulin, a hormone secreted by the pancreas that regulates~     blood glucose (sugar) levels. In many people with hypertension, insulin is not as effective~     in helping the body use glucose. This is called insulin resistance. Insulin also increases~     blood flow into muscle by opening inactive blood vessels. Laboratory studies suggest that~     eating dark chocolate may improve blood pressure. This study will determine whether dark~     chocolate improves insulin resistance or changes how blood vessels react to insulin in~     hypertensive people.~      People between 21 and 65 years of age who have high blood pressure and are not pregnant may~     be eligible for this study. Candidates are screened with a medical history, physical~     examination, and blood and urine tests.~      Participants refrain from eating foods containing chocolate or cocoa for 1 week and then come~     to the clinic on three separate occasions 3 weeks apart for a glucose clamp test and contrast~     ultrasound, described below. At the first glucose clamp test, subjects are randomly assigned~     to drink either a cocoa drink with high anti-oxidant content or one with a very low content~     of anti-oxidant. Each drink will be taken twice a day for 2 weeks. At the end of the 2 weeks,~     they return for a second glucose clamp test. At the second test, they stop taking the cocoa~     drink for 1 week and then start again for another 2 weeks. For this 2-week period, those who~     were given the high anti-oxidant content cocoa drink the first 2 weeks will take the placebo,~     very low anti-oxidant drink this time, and those who took the placebo will now have the high~     anti-oxidant cocoa drink. After this 2 weeks of taking the cocoa drink or placebo, they then~     take the third and last glucose clamp test.~      Glucose clamp test: This test measures how the body responds to insulin. Subjects fast the~     night before each test and do not eat until the test is over, usually in the early afternoon.~     For the test, the subject lies in a bed or reclines in a chair. A needle is placed in a vein~     in each arm - one for collecting blood samples and the other for infusing glucose, insulin,~     and a potassium solution. Blood glucose and insulin levels are measured frequently during the~     test and the rate of the glucose infusion is adjusted to keep blood glucose at the baseline~     (fasting) level. Blood samples are tested for blood count, electrolytes, liver function...~   "
263520|NCT00099463|"~     This study will test whether an experimental vaccine to protect against severe acute~     respiratory syndrome (SARS) is safe, causes any side effects, and causes an immune response.~     SARS affects the respiratory system, usually starting with fever and muscle aches. Patients~     may get a dry cough and have difficulty breathing. Infection may be mild, but it can lead to~     death.~      Vaccines contain substances from an infectious agent, such as a virus, that, when injected~     into a person's body, stimulates production of antibodies that create resistance, or~     immunity, to that agent. The vaccine in this study contains genetic material (DNA) that codes~     for a protein found in the virus that causes SARS. Injected into a muscle, it instructs the~     body to make a small amount of a SARS protein. The vaccine is made from just one small part~     of the code for one SARS protein; a person cannot get SARS from the vaccine.~      Normal volunteers between 18 and 50 years of age who are in general good health may be~     eligible for this 32-week study. Candidates are screened with a physical examination and~     blood and urine tests.~      Participants have nine clinic visits during the study. They receive three vaccine injections,~     given with a system called the Bioinjector 2000® (Registered Trademark), which delivers the~     vaccine through the skin without the use of a needle. Following each injection, participants~     take home a diary card, on which they record their temperature and any vaccine side effects~     daily for 5 days. Participants must immediately report any symptoms to a study physician,~     and, if necessary, go to the clinic for an examination. Participants have the following tests~     and procedures:~        -  Vaccine injections (study day 0, around week 4, and around week 8, with at least 21 days~          between injections)~        -  Medical history and, if needed, physical examination (study day 0 and weeks 2, 4, 6, 8,~          10, 12, 24, and 32)~        -  Check of vital signs and weight (study day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32)~        -  Lymph node examination (day 0 and weeks 2, 4, 6, 8, 10 and 12)~        -  Blood draw (study day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32)~        -  Pregnancy test for women (day 0 and weeks 4, 8 and 32)~        -  Urine sample (day 0 and weeks 2, 4, 6, 8, 10)~   "
263521|NCT00099450|"~     The objectives of this study are to look at the safety and tolerability of the experimental~     drug, how people process the drug, how the drug affects people, and to identify a dose or~     doses to study in subsequent future studies.~   "
263522|NCT00099437|"~     The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant~     with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive~     advanced breast cancer who have failed on a previous endocrine treatment.~   "
263523|NCT00099424|"~     Exercise intolerance and reduced health status have been found in patients with sarcoidosis~     and has been related to skeletal muscle weakness. The present researchers reason that~     skeletal muscle weakness is, at least in part, related to physical inactivity and therefore~     partially reversible following a structured exercise training program. Nevertheless, the~     effects of exercise training have never been studied in patients with sarcoidosis. Therefore,~     the present study is undertaken to explore the effects of exercise training in patients with~     sarcoidosis. A priori, the following hypotheses are formulated:~        -  A 12-week exercise training program improves health status, quality of life and exercise~          capacity in patients with sarcoidosis as compared to sarcoidosis patients without~          exercise intervention.~        -  A 12-week exercise training program improves skeletal muscle function and reduces~          complaints of anxiety and depression in patients with sarcoidosis as compared to~          sarcoidosis patients without exercise intervention.~        -  A 12-week exercise training program reduces circulating levels of inflammatory markers~          in patients with sarcoidosis as compared to sarcoidosis patients without exercise~          intervention.~   "
263524|NCT00099411|"~     The purpose of this study is to assess the effect of heart muscle viability on left~     ventricular (LV) remodeling after a heart attack; to explore the relationships between~     retained viability of the area of tissue death (infarct zone), LV remodeling, response to the~     Occluded Artery Trial (OAT) intervention, and response to late percutaneous coronary~     intervention of the infarct related artery (IRA).~   "
263525|NCT00099385|"~     This project will evaluate the benefit of an enhanced social development program in grades~     3-6 to decrease the onset of risky behaviors in pre-adolescents.~   "
263526|NCT00099372|"~     The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to~     evaluate whether the addition of a second surgical procedure in addition to a procedure for~     female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will~     follow women in the CARE study for 10 years from the time of the surgery to compare success~     and complication rates in the two groups. Recruitment into this study is open only to women~     that already participated in CARE. Recruitment into CARE is closed.~   "
263527|NCT00099359|"~     Giving anti-HIV medications to babies born of HIV positive mothers right after birth can~     lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of~     two different combinations of anti-HIV medications compared to a one drug standard regimen in~     preventing mother to baby transmission. The one drug standard treatment and two combinations~     to be studied are: 1) zidovudine, 2) zidovudine/nevirapine and 3)~     zidovudine/lamivudine/nelfinavir.~   "
263528|NCT00099346|"~     Study with an investigational drug in patients with recurrent or non-responsive colorectal~     cancer or other advanced solid tumors.~      This is an early phase trial and some specific protocol information is proprietary and not~     publicly available at this time. (Full information is available to trial participants).~   "
263529|NCT00099333|"~     This study will look at the safety of substituting exenatide for insulin in patients with~     type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).~   "
263632|NCT00097838|"~     The purpose of this study is to evaluate the safety of and immune response to an alphavirus~     replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States,~     South Africa, and Botswana.~   "
263531|NCT00099307|"~     This study will determine whether magnetic resonance imaging (MRI) can detect damage to~     certain parts of the brain and analyze the thickness of the brain's outer surface in patients~     with multiple sclerosis. MRI is a diagnostic test that uses a strong magnetic field and radio~     waves to obtain images of body organs and tissues. It can sometimes permit diagnosis even~     before symptoms develop.~      MS is a disease of white matter, the fatty covering around the nerves in the brain and spinal~     cord. The nerves themselves are called gray matter. Damage to white matter impairs nerve~     function, leading to a variety of symptoms, such as weakness, vision problems, difficulty~     walking, paralysis, and others. MRI can detect some changes in white matter, but changes that~     may also appear in gray matter may be more difficult to find. This study will use new MRI~     techniques to try to identify gray matter damage in patients with MS.~      Healthy volunteers and people with MS or clinically isolated syndrome (an early stage of MS~     in which the patient has had just one of the problems MS can cause) who are between 18 and 55~     years of age may be eligible for this study. Candidates are screened with a medical history~     and neurological examination, and blood and urine tests.~      Within one month of the screening evaluation, participants undergo MRI scanning on a standard~     1.5 Tesla machine to confirm their health status. (The power of the MRI scanner is measured~     in Tesla; the higher the Tesla, the better the visualization.) For this procedure, the~     subject lies on a table that moves into the scanner (a narrow cylinder with a magnetic~     field), and wears earplugs to muffle loud knocking and thumping sounds that occur during the~     scanning process. During the procedure, a contrast agent called Gadolinium is injected into~     the blood stream to brighten the images. The test lasts about 2 hours, during which time the~     subject must lie still for up to a few minutes at a time.~      Within a month after the first MRI, participants repeat the test for a second time. The~     procedure is identical to the first scan, except a 3.0 Tesla machine is used.~   "
263532|NCT00099294|"~     The primary objectives of the study is to evaluate the effectiveness and safety of~     glufosfamide in subjects with pancreatic cancer who have been previously treated with~     gemcitabine as measured by overall survival compared with best supportive care.~   "
263533|NCT00099281|"~     The purpose of this trial is to study DPPE combined with epirubicin and cyclophosphamide in~     patients with metastatic and/or recurrent breast cancer who may have received previous~     hormone treatment but have not had exposure to anthracycline treatment. Stratification~     allocation will be within the following subgroups:~        1. Prior cytotoxic treatment;~        2. Estrogen receptor status;~        3. ECOG performance status;~        4. Number of cycles of chemotherapy.~   "
263534|NCT00099268|"~     The CELC200A2401 study has been designed in order to evaluate the hypothesis that~     administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy~     is initiated results in a decrease in the risk of the development of motor complications for~     patients with Parkinson's disease.~   "
263535|NCT00099255|"~     This multi-center, phase II study will be conducted to define the toxicity profile and~     antitumor activity of SGN-30 in patients with pcALCL and other closely related~     lymphoproliferative disorders.~   "
263536|NCT00099242|"~     The goal of this research study is to evaluate the safety and efficacy of the rivastigmine~     transdermal patch in patients with probable Alzheimer's Disease.~   "
263537|NCT00099229|"~     This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the~     treatment of manic episodes of bipolar disorder.~   "
263538|NCT00099216|"~     The goal of this research study is to evaluate the effectiveness, tolerability and safety of~     rivastigmine capsules in males and females between the ages of 50 and 85 years old with~     probable vascular dementia.~   "
263539|NCT00099203|"~     This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic~     acid in patients with malignant bone disease experiencing moderate to severe pain. Patients~     will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4~     weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of~     study treatment is 6-12 months, and the target sample size is 100-500 individuals.~   "
263540|NCT00099190|"~     The purpose of this study is to determine the safety of ARQ 501 in combination with docetaxel~     in patients with advanced or metastatic cancer. In addition, the study is designed to observe~     the potential the combination of ARQ 501 and docetaxel have in treating cancer.~   "
263541|NCT00099177|"~     This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral~     Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing~     moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on~     days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic~     acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is~     6-12 months, and the target sample size is 100-500 individuals.~   "
263542|NCT00099164|"~     Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention~     or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored~     Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a~     treatment that substantially reduces the rate of preterm birth in women at high risk for~     preterm delivery (i.e. progesterone therapy). Preterm birth was reduced by 35% among~     progesterone-treated women with a singleton pregnancy when compared with women receiving~     placebo. The current trial compares weekly treatment by injection of progesterone with~     placebo in women pregnant with twins or triplets.~   "
263543|NCT00099151|"~     This study is one of three CALERIE trials that test the hypothesis that a reduced calorie,~     nutritionally sound diet improves biomarkers of aging and prevents some age-related chronic~     diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are~     participating in the CALERIE trial represent a diversity of subject populations and~     interventional strategies.~   "
263544|NCT00099138|"~     This study is one of three CALERIE trials that test the hypothesis that a reduced calorie,~     nutritionally sound diet increases the length of life and prevents some age-related chronic~     diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are~     participating in the CALERIE trial represent a diversity of subject populations and~     interventional strategies.~   "
263545|NCT00099125|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells~     from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and~     irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.~   "
263546|NCT00099112|"~     RATIONALE: Testing of skin that has been exposed to artificial sunlight may help in~     understanding the genetic processes involved in the development of skin cancer.~      PURPOSE: This trial is studying the effect of solar-simulated ultraviolet radiation on skin~     with or without sunscreen in healthy adults with skin that burns easily after only slight~     tanning during sun exposure.~   "
263547|NCT00099099|"~     This study is one of three CALERIE trials that test the hypothesis that a reduced calorie,~     nutritionally sound diet increases the length of life and prevents some age-related chronic~     diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are~     participating in the CALERIE trial represent a diversity of subject populations and~     interventional strategies.~   "
263548|NCT00099086|"~     This phase I trial is studying the side effects and best dose of docetaxel when given with~     radiation therapy and hormone therapy in patients with locally advanced prostate cancer.~   "
263549|NCT00099060|"~     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and to~     see how well it works in treating patients with recurrent glioblastoma multiforme.~   "
263550|NCT00099047|"~     This randomized phase II trial studies how well celecoxib works in preventing multiple~     myeloma in patients with monoclonal gammopathy or smoldering myeloma. Chemoprevention therapy~     is the use of certain drugs to try to prevent the development or recurrence of cancer. The~     use of celecoxib may be effective in preventing multiple myeloma.~   "
263551|NCT00099021|"~     This phase II trial studies how well pioglitazone hydrochloride works in preventing head and~     neck cancer in patients who have oral leukoplakia. Chemoprevention therapy is the use of~     certain drugs to try to prevent the development or recurrence of cancer. The use of~     pioglitazone hydrochloride may be effective in preventing head and neck cancer.~   "
263552|NCT00099008|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of genistein may be effective in preventing~     breast or endometrial cancer.~      PURPOSE: This randomized phase I trial is studying the effectiveness of genistein in~     preventing breast or endometrial cancer in healthy postmenopausal women.~   "
263553|NCT00098995|"~     RATIONALE: Drugs used in chemotherapy, such as tirapazamine and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Tirapazamine may help cisplatin kill more tumor cells by making tumor cells more~     sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Tirapazamine may also make tumor cells more sensitive to radiation therapy. Giving radiation~     therapy in different ways together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of tirapazamine when~     given together with cisplatin and radiation therapy in treating patients with stage IB, stage~     II, stage III, or stage IVA cervical cancer.~   "
263554|NCT00098982|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. It may also help the chemotherapy drugs work better by~     making tumor cells more sensitive to the drugs. Giving bortezomib with fluorouracil,~     leucovorin, and oxaliplatin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given with fluorouracil, leucovorin, and oxaliplatin in treating patients with advanced or~     metastatic colorectal cancer.~   "
263555|NCT00098969|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of resveratrol may prevent cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in~     preventing cancer in healthy participants.~   "
263556|NCT00098956|"~     This phase II trial is studying how well giving UCN-01 together with topotecan works in~     treating patients with small cell lung cancer that relapsed or progressed after previous~     chemotherapy. Drugs used in chemotherapy, such as topotecan, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     UCN-01 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It may also increase the effectiveness of topotecan by making tumor cells more~     sensitive to the drug. Giving UCN-01 together with topotecan may kill more tumor cells.~   "
263557|NCT00098943|"~     RATIONALE: Targeted therapy with tumor necrosis factor combined with a fusion protein may~     stop the growth of solid tumors by stopping blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of NGR-TNF in treating~     patients with advanced solid tumors.~   "
263558|NCT00098917|"~     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body~     build an effective immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients who are undergoing surgery for stage IB, stage II, or stage IIIA non-small~     cell lung cancer.~   "
263559|NCT00098891|"~     Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating~     patients who have metastatic or advanced solid tumors or lymphomas. MS-275 may stop the~     growth of cancer cells by blocking the enzymes necessary for their growth. Isotretinoin may~     help cancer cells develop into normal cells. MS-275 may increase the effectiveness of~     isotretinoin by making cancer cells more sensitive to the drug. MS-275 and isotretinoin may~     also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer.~     Combining MS-275 with isotretinoin may kill more cancer cells~   "
263560|NCT00098878|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see~     how well they work in treating patients with stage IC, stage II, stage III, or stage IV~     ovarian, fallopian tube, or primary peritoneal cancer.~   "
263561|NCT00098865|"~     RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the~     tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor~     cells from dividing so they stop growing or die. Combining thalidomide with temozolomide may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide with~     temozolomide in treating young patients who have relapsed or progressive brain tumors or~     recurrent neuroblastoma.~   "
263562|NCT00098852|"~     RATIONALE: Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive~     iodine.~      PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients~     with locoregionally extensive or metastatic thyroid cancer.~   "
263563|NCT00098839|"~     This Phase II trial is studying how well giving epratuzumab together with an established~     chemotherapy platform works in treating young patients with relapsed acute lymphoblastic~     leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in~     different ways to stop the growth of cancer cells, either by killing them or by stopping them~     from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer~     cells more effectively.~   "
263564|NCT00098826|"~     Phase I trial to study the effectiveness of SB-715992 in treating patients who have acute~     leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes. Drugs used in~     chemotherapy, such as SB-715992, work in different ways to stop cancer cells from dividing so~     they stop growing or die~   "
263565|NCT00098813|"~     This phase II trial is studying how well romidepsin works in treating patients with recurrent~     and/or metastatic thyroid cancer that has not responded to radioactive iodine. Romidepsin may~     stop the growth of tumor cells by blocking the some of the enzymes needed for cell growth. It~     may also help radioactive iodine and chemotherapy work better by making tumor cells more~     sensitive to the drug~   "
263566|NCT00098800|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,~     or coming back. The use of fenretinide may prevent ovarian cancer.~      PURPOSE: This randomized clinical trial is studying how well fenretinide works in preventing~     ovarian cancer in participants who are at high risk of developing ovarian cancer and planning~     to undergo surgery to remove the ovaries.~   "
263567|NCT00098787|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, leucovorin, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the~     tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block~     tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the~     best treatment.~      PURPOSE: This randomized phase II trial is studying giving bevacizumab, oxaliplatin, and~     irinotecan or giving bevacizumab, oxaliplatin, leucovorin, and fluorouracil in treating~     patients with metastatic or recurrent colorectal cancer.~   "
263568|NCT00098774|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Giving rituximab with combination chemotherapy may kill~     more cancer cells.~      PURPOSE: This phase II trial is studying how well rituximab given with combination~     chemotherapy works in treating patients with newly diagnosed primary CNS lymphoma.~   "
263569|NCT00098761|"~     RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of VNP40101M in~     treating young patients with recurrent, progressive, or refractory primary brain tumors.~   "
263570|NCT00098748|"~     Maraviroc (UK-427,857), a selective and reversible CCR5 co-receptor antagonist, has been~     shown to be active in vitro against a wide range of clinical isolates (including those~     resistant to existing classes). In HIV-1 infected patients in the United States, maraviroc~     (UK-427,857) is approved for use as part of combination antiretroviral treatment in~     treatment-experienced and treatment-naive adult subjects. At least 50% of~     treatment-experienced patients are infected with R5-tropic HIV-1 exclusively. However, even~     in patients infected with a dual tropic (R5 + X4) phenotype, a large proportion of the virus~     population still uses CCR5 exclusively. Thus, the purpose of this study is to evaluate the~     antiretroviral activity, and safety, of maraviroc (UK-427,857) (in combination with other~     agents) in HIV infected, treatment experienced patients who are failing their current~     antiretroviral regimen and not infected with R5-tropic virus exclusively. This study will~     involve more than 200 centers globally to achieve a total randomized subject population of~     192 subjects. Patients will be randomly (1:1:1) assigned to one of three groups: Optimized~     Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] +~     maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken~     twice daily, or OBT alone. Randomization was stratified by Enfuvirtide use in OBT (yes/no)~     and Screening HIV-1 RNA level (viral load) (<100,000/≥ 100, 000 copies per milliliter [copies~     per mL]). The study will enroll over approximately a 9 month period with 48 weeks of~     treatment. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20,~     24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16,~     20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes~     apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this~     clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis.~     Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.~   "
263571|NCT00098735|"~     In patients who receive an organ transplant, their body considers this organ as foreign and~     attempts to destroy it. This is called rejection. All patients who receive an organ~     transplant, will take a combination of anti-rejection medications. These medications prevent~     the new organ from being rejected from the body. FTY720 is a new compound that helps prevent~     organ rejection.~   "
263572|NCT00098722|"~     Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown~     to be active in vitro against a wide range of clinical isolates (including those resistant to~     existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy~     for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available~     agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300~     mg twice daily. No significant effects were seen on the QTc interval. The purpose of this~     study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected,~     treatment experienced patients who are failing their current antiretroviral regimen and~     infected with R5-tropic virus exclusively. This study will involve more than 100 centers in~     Europe and Australia to achieve a total randomized subject population of 500 subjects.~     Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background~     Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc~     (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily,~     or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of~     treatment. This may be extended for an additional year depending on the results at 48 weeks.~     Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40~     and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32,~     40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at~     weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical~     study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients~     will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.~   "
263573|NCT00098709|"~     The purpose of this study is to determine if the information provided to the physician by a~     fetal pulse oximeter during labor will reduce the chances of a cesarean delivery.~   "
263574|NCT00098683|"~     RATIONALE: Drugs used in chemotherapy, such as amifostine, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well amifostine works in treating young patients~     with newly diagnosed de novo myelodysplastic syndromes.~   "
263575|NCT00098670|"~     This phase II trial is studying how well giving fludarabine together with rituximab followed~     by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal~     antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others can find cancer cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as fludarabine, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving fludarabine together with rituximab~     followed by alemtuzumab may kill more cancer cells.~   "
263576|NCT00098631|"~     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their~     growth. This phase II trial is studying how well lapatinib works in treating patients with~     recurrent and/or metastatic head and neck cancer.~   "
263577|NCT00098618|"~     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their~     growth or by blocking blood flow to the tumor. Interferon alfa may interfere with the growth~     of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa kill~     more tumor cells by making tumor cells more sensitive to the drug. Giving sorafenib together~     with interferon alfa may kill more tumor cells. This phase II trial is studying how well~     giving sorafenib with interferon alfa works in treating patients with locally advanced or~     metastatic kidney cancer.~   "
263578|NCT00098605|"~     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their~     growth. This phase II trial is studying how well lapatinib works in treating brain metastases~     in patients with stage IV breast cancer and brain metastases.~   "
263579|NCT00098579|"~     This phase I trial is studying the side effects and best dose of alvocidib when given with~     doxorubicin hydrochloride in treating patients with metastatic or recurrent sarcoma that~     cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride~     and alvocidib, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Alvocidib may also help doxorubicin~     hydrochloride work better by making tumor cells more sensitive to the drug. Giving more than~     one drug may kill more tumor cells~   "
263580|NCT00098566|"~     RATIONALE: Studying the long-term effects of cancer treatment in cancer survivors may help~     improve the ability to plan effective treatment and follow-up care.~      PURPOSE: This phase II trial is studying the long-term effects of iodine I 131 tositumomab~     and autologous bone marrow or stem cell transplantation in patients with relapsed or~     refractory non-Hodgkin's lymphoma.~   "
263581|NCT00098553|"~     RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with~     stage IV melanoma.~   "
263582|NCT00098540|"~     This phase II trial is studying how well sorafenib works in treating patients with stage IIIB~     or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. It may also stop the growth of non-small~     cell lung cancer by blocking blood flow to the tumor.~   "
263583|NCT00098527|"~     This phase II trial is studying how well FR901228 works in treating patients with refractory~     stomach cancer or gastroesophageal junction. Drugs used in chemotherapy, such as FR901228,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking~     some of the enzymes needed for their growth.~   "
263584|NCT00098514|"~     RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of~     talotrexin in treating patients with advanced or recurrent solid tumors.~   "
263585|NCT00098501|"~     This phase I trial is studying the side effects, best way to give, and best dose of CCI-779~     and EKB-569 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such~     as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. EKB-569 may stop the growth of tumor cells by~     blocking some of the enzymes needed for their growth. Giving CCI-779 together with EKB-569~     may kill more tumor cells.~   "
263586|NCT00098488|"~     This phase I trial is studying the side effects and best dose of~     17-N-allylamino-17-demethoxygeldanamycin when given with or without rituximab in treating~     patients with relapsed B-cell chronic lymphocytic leukemia or prolymphocytic leukemia. Drugs~     used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others~     interfere with the ability of cancer cells to grow and spread. Monoclonal antibodies may kill~     cancer cells that are left after chemotherapy. Giving~     17-N-allylamino-17-demethoxygeldanamycin with or without rituximab may kill more cancer~     cells.~   "
263587|NCT00098475|"~     This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how~     well it works compared to lenalidomide and standard-dose dexamethasone, given with or without~     thalidomide, in treating patients with multiple myeloma. Biological therapies, such as~     lenalidomide, may stimulate the immune system in different ways and stop cancer cells from~     growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by~     blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill~     more cancer cells.~   "
263634|NCT00097812|"~     The purpose of this study is to assess bone mineral density in patients switching from an~     oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.~   "
263588|NCT00098462|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as sirolimus, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells.~     The tumor is said to be resistant to chemotherapy. Giving gefitinib together with sirolimus~     may reduce drug resistance and allow the tumor cells to be killed.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of sirolimus when~     given with gefitinib and to see how well they work in treating patients with recurrent or~     refractory stage IIIB or stage IV non-small cell lung cancer.~   "
263589|NCT00098436|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Temozolomide may also help VNP40101M kill more cancer cells by making cancer cells~     more sensitive to the drug. Giving temozolomide together with VNP40101M may kill more cancer~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide and~     VNP40101M in treating patients with relapsed or refractory leukemias.~   "
263590|NCT00098423|"~     This phase I trial is studying the side effects and best dose of tanespimycin when given with~     cytarabine in treating patients with relapsed or refractory acute myeloid leukemia, acute~     lymphoblastic leukemia, chronic myelogenous leukemia, chronic myelomonocytic leukemia, or~     myelodysplastic syndromes. Drugs used in chemotherapy, such as tanespimycin and cytarabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Tanespimycin may also help cytarabine kill more cancer cells by~     making cancer cells more sensitive to the drug. Giving tanespimycin together with cytarabine~     may kill more cancer cells.~   "
263591|NCT00098397|"~     This phase II trial is studying how well FR901228 works in treating patients with metastatic~     breast cancer. Drugs used in chemotherapy, such as FR901228, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth~   "
263592|NCT00098384|"~     The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in~     the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.~   "
263593|NCT00098371|"~     This phase II trial is studying how well flavopiridol works in treating patients with chronic~     lymphocytic leukemia or prolymphocytic leukemia. Drugs used in chemotherapy, such as~     flavopiridol, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing~   "
263594|NCT00098358|"~     Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4)~     is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4~     is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase.~     This study will test the safety and efficacy of zileuton in the treatment of facial acne.~   "
263595|NCT00098345|"~     The purpose of this open label, two stage, phase II study is to evaluate the efficacy and~     tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary~     thyroid carcinoma.~   "
263596|NCT00098332|"~     RATIONALE: Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes~     necessary for their growth.~      PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have~     refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell~     lymphoma.~   "
263597|NCT00098319|"~     Cleft lip and palate are a significant component of morbid human birth defects in the~     developing world. By supplementing a high-risk group of women with folic acid (4.0 mg versus~     0.4 mg) from preconception and continuing throughout the first 3 months of pregnancy in the~     state of Sao Paulo, Brazil, this study aims to reduce the recurrence of cleft lip and palate.~   "
263598|NCT00098306|"~     Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown~     to be active in vitro against a wide range of clinical isolates (including those resistant to~     existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy~     for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available~     agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300~     mg twice daily. No significant effects were seen on the QTc interval. The purpose of this~     study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected,~     treatment experienced patients who are failing their current antiretroviral regimen and are~     infected with R5-tropic virus exclusively. This study will involve more than 100 centers from~     the US and Canada to achieve a total randomized subject population of 500 subjects. Patients~     will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT~     (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150~     mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The~     study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be~     extended for an additional year depending on the results at 48 weeks. Physical examinations~     will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples~     will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.~     Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24~     for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood~     sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo~     a 12-lead electrocardiogram at study entry, weeks 24 and 48.~   "
263599|NCT00098293|"~     Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown~     to be active in vitro against a wide range of clinical isolates (including those resistant to~     existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy~     for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available~     agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300~     mg twice daily. No significant effects were seen on the QTc interval. The goal of this study~     is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each~     are combined with two other antiretroviral agents, in patients who are previously naive to~     antiretroviral therapy. This study will involve approximately 200 centers from around the~     world to achieve a total randomized subject population of 1071 subjects. Patients will be~     randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to~     zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily~     added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily)~     added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over~     approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks~     of treatment. This may be extended for an additional 3 years depending on the results at 96~     weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24,~     32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4,~     8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn~     twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857)~     pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for~     non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at~     study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed,~     at selected centers, at study entry and week 96. Patients will be asked to complete a symptom~     distress questionnaire at study entry, weeks 12, 24, 48 and 96.~   "
263600|NCT00098280|"~     This study will examine the safety and effectiveness of the experimental drug eculizumab in~     treating patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder of red~     blood cells that leads to premature destruction of the cells and resulting anemia. Patients~     may be at high risk of blood clots and may develop bone marrow failure or aplastic anemia,~     with low white blood cell and platelet counts. Eculizumab is a monoclonal antibody that may~     help improve the survival of red blood cells.~      Patients 18 years of age and older with PNH who require blood transfusions for anemia and~     have received at least four transfusions in the 12 months preceding evaluation for this study~     may be eligible to enroll. Candidates are screened with a medical history, physical~     examination, and check of vital signs.~      Participants have an electrocardiogram (EKG) and blood and urine tests, and are vaccinated~     against Neisseria meningitides, a common bacteria that can cause a disabling or fatal type of~     meningitis. They then enter an observation phase of the study, with monthly visits during~     which they complete a questionnaire; update their health status, transfusion record, and~     medication use; have their vital signs checked and PNH symptoms evaluated; have blood and~     urine tests; and receive a transfusion, if necessary. These visits continue for up to 3~     months until patients receive a qualifying transfusion; that is, a transfusion given as a~     consequence of a certain hemoglobin level with symptoms or a different level without~     symptoms.~      Patients are then randomly assigned to receive either eculizumab or a placebo (salt solution~     with no active ingredient). Both study medications are given intravenously (through a vein)~     over 30 minutes once a week for five doses and then once every 2 weeks for another 11 doses.~     At each treatment visit (study weeks 0-24), patients update their health status, transfusion~     records, and medication use; have their vital signs checked; and provide a blood sample. At~     various visits, they also complete a questionnaire, provide a urine sample and have an EKG.~     At the last treatment visit (week 26 or the final visit for patients who end their~     participation before visit 18) patients have a complete physical examination in addition to~     the procedures listed above.~   "
263601|NCT00098267|"~     This study will explore how bacteria colonize human teeth and how this process changes over~     the lifetime of individuals. It will include an investigation of transmission of bacteria~     that initiate colonization between adults and from adults to infants.~      Selected NIH scientists and members of their immediate families, including infants, are~     eligible for this study. Participants provide a small sample of saliva and a sample of~     bacteria collected by rubbing a cotton swab over the surfaces of the lower four incisors.~     Adults collect and submit their own specimens; a dentist collects specimens from children.~   "
263602|NCT00098254|"~     This study will investigate the effects and side effects of BAY 43-9006 in patients with~     advanced, recurrent, or refractory non-small cell lung cancer (NSCLC). BAY 43-9006 is one of~     a new class of anticancer agents known as bi-aryl ureas.~      Patients 18 years of age and older with NSCLC that has recurred or progressed after one~     regimen of chemotherapy may be eligible for this study. Candidates are screened with a~     medical history and physical examination; blood tests; tumor biopsy (see below); chest x-ray;~     electrocardiogram; and imaging studies, including positron emission tomography-computed~     tomography (PET-CT, see below) and dynamic, contrast-enhanced MRI (DCE-MRI, see below).~      Participants take BAY 43-9006 by mouth twice a day, morning and evening. On the first and~     15th days of treatment, patients are admitted to the hospital for pharmacokinetic studies;~     that is, a test of how the body handles the drug. For the test, blood is collected at~     intervals (at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, 12 and 24 hours after ingestion) to~     determine the drug's level in the bloodstream. Treatment with BAY 43-9006 continues until the~     study doctor determines that the medication is not beneficial or the patient wishes to~     withdraw from the study.~      In addition to drug therapy, patients undergo the following tests and procedures:~        -  Physical examination every 4 weeks~        -  Blood pressure checks once a week during the first 4 weeks~        -  Blood tests every week~        -  CT scans or other imaging tests, such as ultrasound or MRI, every 8 weeks to evaluate~          the tumor's response to treatment. CT is an x-ray test that provides detailed pictures~          of the inside of the body. It can be done from different angles, providing a~          3-dimensional picture of the part of the body being studied and allowing the doctor to~          see the location, nature, and extent of disease. MRI uses a powerful magnet and radio~          waves instead of x-rays to produce accurate, detailed pictures of organs and tissues.~        -  PET-CT approximately every 8 weeks to look at how different parts of the body take up~          and use glucose (a sugar nutrient). Because rapidly growing cells, such as tumors, use~          more sugar than normal cells do, this test can be used to detect cancer. For the test,~          the patient is given an injection of a sugar solution in which a radioactive tracer has~          been attached to the sugar molecule. A special camera detects the radiation emitted by~          the solution, and the resulting images show how much sugar is being used in various~          parts of the body. PET-CT uses the PET scan in combination with standard CT in a machine~          that does both tests.~        -  DCE-MRI after 2 weeks of treatment. This test uses MRI with a special non-radioactive~          dye to examine blood flow in a certain part of the body.~        -  Tumor biopsy (optional) after 2 weeks of treatment. A biopsy is the surgical removal of~          a small piece of tissue. The tumor biopsy is done either using a small bore needle under~          CT guidance or by direct visualization using a laparoscope/thoracoscope. For the needle~          biopsy, a needle is inserted through the skin and guided by CT into the tumor mass. For~          the laparoscopy/thoracoscopy, the patient is sedated or asleep and small lighted tubes~          are inserted into small holes made in the skin. The tumor is located and tissue~          withdrawn.~   "
263603|NCT00098241|"~     The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican)~     administered to pediatric renal transplant recipients, and to provide additional safety data.~   "
263604|NCT00098228|"~     The trial is designed to identify an appropriate dose of QAB149 for delivery via a multiple~     dose inhaler for use in the COPD Phase III program.~   "
263605|NCT00098215|"~     The purpose of this study is to determine whether a specialized, technology-based training~     program in tobacco prevention is more effective than standard training for pediatric~     residents who counsel youth and their parents.~   "
263606|NCT00098202|"~     Malnutrition is a serious health problem in the developing world. This study looks at the~     effects of changing the type of basic food staple (corn) used in Guatemala and infant zinc~     supplementation on infants' growth, development, and illnesses from infectious diseases.~   "
263607|NCT00098189|"~     This extension study is being conducted to collect post-treatment safety information on~     patients who previously participated in the core clinical trial.~   "
263608|NCT00098163|"~     The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine,~     ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.~   "
263609|NCT00098150|"~     This extension study is being conducted to collect post-treatment safety information on~     patients who previously participated in the core clinical trial.~   "
263610|NCT00098137|"~     Hypothesis:~      Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) reduces the incidence of~     episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12~     months by more than 25% compared to standard medication without angiotensin II type 1~     receptor.~      A total of 422 subjects will be included in the two study groups. The treatment arm will~     receive 40mg Olmesartan per day, the remaining patients will receive placebo. Follow-up is 12~     months. Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes~     of atrial fibrillation (AF) every day. Concomitant therapy with AV-nodal blocking drugs are~     allowed during the study. In case of severe AF-induced symptoms, an antiarrhythmic recovery~     medication (amiodarone) is allowed during follow-up.~   "
263611|NCT00098124|"~     Antidepressants of all varieties represent a common form of therapy for many chronic states~     including fibromyalgia. The majority of antidepressants increase the levels of serotonin or~     norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and~     serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.~   "
263612|NCT00098111|"~     The purpose of this study is to identify an optimal weight based dose of azathioprine that is~     safe and effective in the treatment of subjects with active Crohn's disease requiring~     treatment with corticosteroids, and for maintaining remission in those subjects.~   "
263613|NCT00098098|"~     The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen~     (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when~     given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day~     0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein~     dosage level.~   "
263614|NCT00098085|"~     Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an~     autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with~     resectable non-small cell lung cancer.~      Vaccine production will be attempted on all patients who undergo surgery and meet all~     inclusion/exclusion criteria.~   "
263615|NCT00098072|"~     This study will examine and test healthy volunteers and patients with pulmonary hypertension~     to try to learn more about the disease and find better ways to detect, treat, and, if~     possible, slow progression. Pulmonary hypertension is a rare blood vessel disorder of the~     lung in which the pressure in the pulmonary artery (the blood vessel that leads from the~     heart to the lungs) rises above normal levels and may become life-threatening.~      Normal volunteers and patients with pulmonary hypertension 18 years of age and older may be~     eligible for this study. All candidates are screened with a review of their medical records.~     Normal volunteers also have a medical history, electrocardiogram, echocardiogram (heart~     ultrasound), and pulmonary function test, in which the subject breathes in and out of a tube~     that measures lung volume, mechanics and function.~      All participants undergo the following tests and procedures:~        -  Echocardiogram to measure heart function and blood pressure in the lungs. A small probe~          held against the chest uses sound waves to obtain pictures of the heart.~        -  Magnetic resonance imaging (MRI) to evaluate the heart's pumping action. Subjects lie on~          a stretcher that slides into a long, tube-shaped scanner. The machine uses a magnetic~          field and radio waves to obtain images of the heart.~        -  6-minute walk to measure how far the subject can walk in 6 minutes. Subjects walk around~          the hospital for 6 minutes at a comfortable pace.~        -  Exercise testing to measure the ability to exercise and the subject's oxygen levels~          during exercise. Subjects exercise on a bike or treadmill while the oxygen and carbon~          dioxide they breathe are measured using a small device placed in the mouth.~        -  Right heart catheterization to measure pressure in the heart and lungs. A small catheter~          (plastic tube) is placed in an arm vein. A longer catheter called a central line is~          placed in a deeper vein in the neck or just below the neck, or in the leg or arm. A~          long, thin catheter that measures blood pressure directly is then inserted into the vein~          and advanced through the chambers of the heart into the lung artery to measure all the~          pressures in the heart and obtain blood samples.~        -  Genetic and protein studies. DNA, RNA, and proteins from blood samples are studied for~          genes and proteins that might predict the development or progression of pulmonary~          hypertension.~      In addition to the above, patients whose pulmonary hypertension was caused by a blood vessel~     injury undergo the tests described below. The right heart catheter inserted for the~     catheterization procedure remains in place to obtain measurements of the effects of nitric~     oxide and nitrite in the following procedures:~        -  Inhalation of nitric oxide (a gas naturally produced by cells lining arteries) at~          30-minute intervals to examine its effect on lung and heart pressures.~        -  Inhalation of aerosolized nitrite at 5-minute intervals to measure its effects on lung~          and heart pressures.~        -  Inhalation of nitric oxide for up to 24 hours to obtain multiple measurements of its~          effect on lung and heart pressures.~        -  Blood draws for laboratory tests.~      In patients whose pulmonary hypertension was caused by a blood vessel injury, we also plan to~     follow response to standard therapy. After the initiation of standard therapy, we will~     restudy the same parameters (excluding NO and sodium nitrite studies) in these patients at~     approximately 4 months, and yearly for 5 years~   "
263616|NCT00098059|"~     This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir~     in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir~     (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive~     multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess~     safety and tolerability. Part B will start only after PK data from Part A had been analyzed.~   "
263617|NCT00098046|"~     Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is~     usually a self-limiting illness characterized by fever and a rash. Serious complications can~     include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is~     not a standard of care in immunocompetent children, but is recommended whenever a risk of~     complication exists. This study will evaluate the safety and blood levels of a new~     formulation of famciclovir in children 1-12 years of age.~   "
263618|NCT00098033|"~     The goals and objectives of this project are to evaluate the antileukemic activity of the~     investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute~     lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic~     phases.~   "
263619|NCT00098020|"~     This is a pilot study of retinoids for patients with unsatisfactory response to conventional~     treatment of nephrotic syndrome due to focal segmental glomerulosclerosis or minimal change~     disease, two renal disorders associated with putatively pathogenic malfunctioning of~     glomerular podocytes. The hypothesis that retinoids may have reparative effects on these~     cells is based on previous research showing that retinoids promote the differentiation or~     redifferentiation of aberrant epithelial cells. Results obtained by 6 months of treatment~     with retinoids (that have been approved for non-renal indications) will be used as~     preliminary information upon which to base further testing of these agents in formal clinical~     trials in refractory cases of these nephrotic syndromes.~   "
263620|NCT00098007|"~     The study is designed to evaluate whether Neoral dose optimization together with a~     therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the~     pivotal cardiac trial while maintaining the efficacy.~      This objective will be assessed by comparing renal function post-transplant between 2 groups~     of patients.~   "
263621|NCT00097994|"~     The purpose of this study is to follow a woman's progression through menopause in order to~     examine the effects on health related quality of life and use of health care resources, and~     to understand how women are using alternative therapies.~   "
263622|NCT00097981|"~     The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL~     (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in~     treating newly diagnosed patients with multiple myeloma. The number of patients whose~     multiple myeloma disappears for a period of time (complete Response) will be studied to make~     the determination of which treatment is more effective.~   "
263623|NCT00097968|"~     Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection~     that can happen after heart transplantation.~      It is usually used in combination with other immunosuppressive drugs such as cyclosporine.~     The purpose of this study is to evaluate the change in kidney function after beginning~     everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with~     everolimus, in adult cardiac transplant patients who have had their transplanted heart for at~     least 1 year and who have cardiac allograft vasculopathy.~   "
263624|NCT00097955|"~     Study of the efficacy and safety of aliskiren when added to losartan and optimal~     antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders~     to monitor improvement in any of these conditions.~   "
263625|NCT00097942|"~     Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms~     associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of~     schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized~     that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving~     signal to noise ratio and thereby improving cognitive symptoms.~   "
263626|NCT00097929|"~     A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral~     investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.~   "
263627|NCT00097916|"~     About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation.~     There are drawbacks associated with the currently available therapeutic interventions for~     agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients~     with moderate to severe AD treated with memantine, there were fewer incidences of agitation.~     It is hypothesized that memantine will be effective in reducing the symptoms of agitation~     associated with moderate to severe Alzheimer's Disease.~   "
263628|NCT00097903|"~     The purpose of this study is to determine the maximum safe dose of orally administered~     Karenitecin (BNP1350) in patients with solid tumors.~   "
263629|NCT00097890|"~     This study will determine the safety and effectiveness of the drug Replagal for treating~     people with Fabry disease, an inherited metabolic disorder. In this disease, an enzyme called~     alpha-galactosidase A, which normally breaks down a lipid (fatty substance) known as~     ceramidetrihexoside, is missing or does not function properly. As a result, the lipid~     accumulates in the body, causing problems with the kidneys, heart, nerves, and blood vessels.~     This study will examine whether replacing the missing alpha-galactosidase A with a~     genetically engineered form of the enzyme called Replagal can reverse the illness.~      Patients with Fabry disease who are 18 years of age or older and have completed 10 weeks of~     Replagal therapy as participants in protocol TKT027 may be eligible for this 6-month study~     extension.~      Participants undergo the following tests and procedures:~        -  Intravenous (IV) infusions of Replagal every other week over 25 weeks for a total of 13~          infusions, with close monitoring during and after the infusions.~        -  Brief safety evaluations at the time of each infusion, including a check of vital signs~          (blood pressure, pulse, breathing rate, temperature), review of any side effects, and~          review of medications.~        -  Comprehensive evaluations at baseline (before starting Replagal therapy), after 13 and~          25 weeks of therapy, and 30 days after completing therapy. These include a medical~          history and physical examination, symptoms and pain questionnaire, blood and urine~          tests, check of vital signs, electrocardiogram (EKG), 2-hour Holter monitor, and sweat~          test (QSART).~   "
263630|NCT00097877|"~     This trial is conducted in the United States of America (USA). The purpose of this study is~     to test whether Biphasic Insulin Aspart 70/30 twice a day with Metformin improves glycemic~     control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who~     are inadequately controlled on basal insulin plus oral anti-diabetic therapy.~   "
263631|NCT00097851|"~     PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new~     blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients~     with non-small-cell lung cancer who haven't responded to first-line therapies (platinum-based~     drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months~     after starting docetaxel treatment. The PR88202 study has been designed to compare two~     different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which~     is more effective against the cancer. It is hoped that the combination of PI-88 with~     docetaxel will allow patients to extend the time it takes for their disease to progress, and~     also to improve their quality of life.~   "
263636|NCT00097786|"~     This study is a test of the safety and effectiveness of two drugs, one for diabetes and one~     for hypertension, in keeping patients with high lab values of glucose from progressing to~     frank diabetes and developing cardiovascular complications. People in this study cannot have~     frank diabetes but are considered borderline based on blood tests. People in the study take~     none, one or both of the drugs and do not know which one(s) they are taking.~   "
263637|NCT00097773|"~     Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung~     function. Antibiotic medications have been proven effective at reducing Pseudomonas~     aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF.~     The purpose of this study is to compare the effectiveness of treatment based on quarterly~     culture results versus consistent quarterly antibiotic treatment at reducing PA infection in~     children with CF.~   "
263638|NCT00097760|"~     The purpose of this study is to determine if natalizumab in combination with Glatiramer~     Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with~     relapsing-remitting Multiple Sclerosis (MS).~   "
263639|NCT00097747|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum~     pharmacologically active dose of peginesatide in Healthy Volunteers.~   "
263640|NCT00097734|"~     The purpose of this study is to compare the efficacy (by assessing the clinical success of~     treatment) of intravenous antibiotic therapy with ertapenem in patients with acute attacks of~     sigmoid diverticulitis for 4 vs. 7 days.~   "
263641|NCT00097721|"~     The purpose of this study is to determine if E7389 is a safe and effective treatment for~     advanced/metastatic breast cancer.~   "
263642|NCT00097708|"~     The purpose of this study is to determine whether an experimental anti-anxiety medication is~     effective in the treatment of Generalized Anxiety Disorder.~   "
263643|NCT00097695|"~     The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin~     antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with~     hereditary angioedema (HAE).~   "
263644|NCT00097682|"~     This study will explore what research patients understand about financial collaborations in~     the research setting and their concerns about these collaborations. Financial partnerships~     are crucial to advancing medical research; however, they are giving rise to increasing~     concerns about financial conflicts of interest and possible impacts on the integrity of~     research and patient safety. This study will examine patients' views about financial ties~     between drug companies and the doctors running research studies, as well as ties between the~     drug companies and the cancer centers where the studies are conducted.~      Patients 18 years of age and older who are enrolled in cancer studies at the National Cancer~     Institute in Bethesda, MD; the Fred Hutchinson Cancer Research Center in Seattle, WA; the~     Dana-Farber Cancer Institute in Boston, MA; the Columbia Comprehensive University Herbert~     Irving Cancer Center in New York, NY; and the University of Colorado Cancer Center in Denver,~     CO, may be eligible for this study.~      Participants are interviewed about the following:~        -  Patients' awareness and understanding about individual and institutional financial~          conflicts of interest, and how such conflicts, if they exist, are being managed~        -  The impact of a researcher's financial ties on the patient's decision to participate in~          that researcher's study~        -  The impact of the institution's financial ties on the patient's decision to participate~          in research at that institution~        -  Attitudes about policies and practices regarding conflicts of interest in the research~          setting~        -  Attitudes about disclosure of conflicts of interest in the research setting~        -  Patient symptoms and performance~        -  Patient's cancer trial~        -  Patient's cancer history~        -  Patient's trust~        -  Patient demographics (gender, age, race, religion, education, income, health insurance,~          employment).~   "
263645|NCT00097669|"~     The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary~     stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug,~     B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk~     factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial~     infarction) and vascular death in patients with recent stroke or transient ischemic attack~     (TIA). All patients presenting to one of the participating neurologists or general physicians~     within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible~     for this trial. Eligible patients will be randomized in a double-blind fashion to receive~     multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event~     stroke, myocardial infarction, or death from any vascular cause, whichever occurs first.~     Our target is to recruit a total of 8,000 patients over the next two years with a median~     follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to~     continue until December 2005. We aim to complete final follow-up by the end of 2006. However,~     the Steering Committee will be flexible in dictating the need for ongoing recruitment and~     continuing follow-up, depending on the overall rate of the primary outcome event in the~     entire cohort at each interim analysis.~   "
263646|NCT00097656|"~     The purpose of this study is to determine whether maternal periodontal therapy (tooth~     cleaning) decreases the rate of preterm deliveries at <37 weeks gestation and to determine~     the effects of maternal periodontal therapy on the birth weight of infants born less than 37~     weeks gestation.~   "
263647|NCT00097643|"~     The purpose of this study is to examine the relative and combined efficacy of a physical~     activity and health promotion program to help sedentary adults over age 70 maintain an~     independent life style.~   "
263648|NCT00097630|"~     The purpose of this study is to determine the impact of a new RN/RRT (Registered~     Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a~     ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening~     trials) combined with daily assessments of patients while they are breathing on their own~     (spontaneous breathing trials).~   "
263649|NCT00097617|"~     This study is a multicenter, open-label, observational, postmarketing surveillance study that~     will collect information on the use of Genentech growth hormone (GH) preparations to treat~     children with CRI in the United States.~   "
263650|NCT00097604|"~     The purpose of this study is to examine the way valerian, an herbal sleep agent, is absorbed~     and distributed in the body. This study will also compare the effects of valerian after 1~     week versus after 2 weeks.~   "
263651|NCT00097591|"~     The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as~     a possible treatment for patients with acute coronary syndrome (heart attack or chest pain)~     who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a~     balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is~     better at reducing deaths, future heart attacks, or stroke.~   "
263652|NCT00097578|"~     This is an observational study designed to follow patients with metastatic or locally~     advanced and unresectable colorectal cancer who are receiving Avastin in combination with~     chemotherapy and whose cancer has been either previously untreated or treated <=4 months~     prior to enrollment.~   "
263653|NCT00097565|"~     This is a prospective, observational, longitudinal, multicenter study of patients with newly~     diagnosed follicular Non Hodgkin's Lymphoma (NHL) designed to delineate differences in~     clinical outcome by comparing the effectiveness and safety of common treatment regimens.~   "
263654|NCT00097552|"~     This study is a multicenter, open-label, observational, postmarketing surveillance study of~     Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the~     United States and Canada.~   "
263655|NCT00097539|"~     The purpose of this multicenter, open-label, observational, post-marketing surveillance study~     is to collect long term safety and efficacy information on growth hormone (GH) products:~     Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ~     (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) in the~     treatment of pediatric growth disorders for which GH is prescribed.~   "
263656|NCT00097526|"~     This study is a multicenter, open-label, postmarketing surveillance study. The substudy will~     collect information on BMD in adolescents and young adults with GHD or Turner syndrome who~     are completing GH treatment for statural indications.~   "
263657|NCT00097513|"~     This study is a multicenter, open-label, observational, postmarketing surveillance study that~     will collect information on the use of Genentech GH preparations to treat GH-deficient~     subjects with optimal GH dosing during puberty.~   "
263658|NCT00097500|"~     This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide~     and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2~     diabetes mellitus using metformin.~   "
263659|NCT00097487|"~     This study is a Phase IV, prospective, nonrandomized, community-based study of clinical~     outcomes in patients with metastatic breast cancer treated with Herceptin and a taxane.~   "
263660|NCT00097474|"~     This study will examine the effects of cortisol (hydrocortisone), melatonin, a combination of~     cortisol and melatonin, and placebo (an inactive substance) on jet lag symptoms. Jet lag is a~     term used to describe symptoms people commonly experience after rapid travel across several~     time zones. The cause of jet lag is not known, but various hormones, including cortisol and~     melatonin, have a day-to-night pattern of secretion and play a role in maintaining the body's~     internal rhythms. This study will test whether taking cortisol, melatonin, or both can help~     re-establish the body's day-night cycle and result in less jet lag.~      People between 18 and 65 years of age who are planning a non-stop eastward flight with the~     following characteristics may be eligible for this study:~        -  Crossing six to eight time zones (6 to 8 hours difference between Eastern Standard Time~          and the destination)~        -  Destination between 30 and 50 latitudes (approximately Cairo to London)~        -  Evening flight (5 PM to midnight) with morning arrival~        -  Remaining abroad at least 4-10 days~      Candidates must have a body mass index (BMI) between 20 and 30 kg/M (not too thin and not~     overweight) and must not be taking medicines that affect sleep or cortisol or melatonin~     levels. Prospective participants are screened with a medical history, blood tests, and check~     of blood pressure, height, and weight.~      Pre-flight Procedures~      Participants keep a sleep journal 3 days before the flight. For 1 day within 3 days of the~     flight they fill out jet lag and sleepiness questionnaires and collect morning and bedtime~     saliva samples for measurement of cortisol and melatonin. The saliva is collected by chewing~     on two small cotton pads and spitting them into a tube. Premenopausal women provide a urine~     sample the week before the flight to test for pregnancy. On the day of the flight, the~     participants do not collect saliva or fill out sleep logs or questionnaires. They are given~     two bottles with study medication. One bottle, labeled AM, contains either hydrocortisone~     or placebo; the other, labeled PM, contains either melatonin or placebo.~      Post-flight Procedures~      Upon arriving at their destination in the morning, participants obtain a saliva sample and~     take one of the capsules in the AM bottle. At bedtime, they collect saliva and then take~     one of the PM capsules. They repeat the medication doses for a total of 4 days and repeat~     the saliva collections on days 2 through 4, 7 and 10 after arrival. In addition, participants~     complete jet lag and sleep questionnaires in the morning, afternoon, and just before bedtime~     on the day of arrival and on days 2 through 4, 7 and 10.~      After they return from their trip, participants are seen at the NIH Clinic to bring in their~     saliva specimens and review their questionnaires with study investigators.~   "
263661|NCT00097461|"~     This study will explore ways in which employee benefits may be designed to improve people's~     health, through examining the viewpoints and preferences of low-income people. A person's~     health is affected not only by being able to receive health care but also by several factors~     such as income and education. People with lower incomes have been found to be not as healthy~     as those with higher incomes. While the governments of many countries in the Organization for~     Economic Cooperation and Development are currently working on public policy to address this~     topic, the likelihood is small that the United States, given its market-based economy, will~     do the same. However, owing to the heavy reliance in the United States on employer-sponsored~     health insurance, it would be useful to explore the possibility of insuring some of the~     measures that people can take to improve their health, and to do that through employee~     benefit packages. Solutions might include extended unemployment insurance, more education,~     job training, exercise programs, help for housing, disability insurance, and extra retirement~     benefits.~      Adults who have a minimum of a sixth-grade reading level, have low incomes, are English~     speaking may be eligible for this study. For recruitment, 400 people who live and work in the~     Washington, D.C, area will be invited to participate, and about12 people will take part in~     each session. Unless people in the study participate during working hours, they will each be~     paid $75 at the conclusion of the session.~      The study consists of one phase, in which participants will engage in a group exercise that~     lasts for approximately 2-1/2 hours. During that time, participants will have the chance to~     say what employee benefits they would choose, if the opportunity arose, to improve their~     health. They will first make those choices by themselves and then make choices along with~     other people in the group. While group members talk, the discussion will be recorded on a~     tape recorder. Participants will be asked to give information about themselves and their~     opinions but will not be asked for any information that identifies them personally, except~     for data needed to pay participants with a paycheck. They will also get to use a computer and~     will be shown how to use it, if necessary. If videotaping or photographs are done during the~     exercise, the investigators of the study will ask for separate signed permission to do so.~     Participants will be asked to respect the privacy of others in the group and to not discuss~     the opinions of others after leaving the session.~   "
263662|NCT00097448|"~     This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected~     into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing~     loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).~   "
263663|NCT00097435|"~     This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety,~     tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to~     respond to previous interferon alfa therapy.~   "
263664|NCT00097422|"~     The purpose of this study is to investigate the safety and perform preliminary clinical~     evaluation in patients with mild to moderate CDAD.~   "
263665|NCT00097409|"~     The purpose of this study is to determine how effective and safe a new investigational drug~     is in treating persistent or recurrent ovarian cancer in patients who have received a~     platinum/taxane based chemotherapy and whose disease continues to progress. The treatment~     involves a 1-hour treatment given intravenously (IV), and repeated once every 21 days. A~     patient may continue to receive the treatment as long as they are benefiting from the~     treatment. Blood samples will be taken at specific times over a 24 hour period to measure the~     amount of drug in your body at specific times after the drug is given. Blood samples will~     also be taken for routine lab tests such as complete blood counts and clinical chemistries.~     Physical exams will be performed before each treatment.~   "
263836|NCT00095082|"~     This trial is conducted in Europe and the United States of America (USA). The purpose of this~     study is to test whether insulin detemir is a safe and at least as effective alternative to~     insulin glargine for the control of blood glucose in basal/bolus therapy in patients with~     type I diabetes.~   "
263666|NCT00097396|"~     The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule~     of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular~     (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to~     evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in~     healthy volunteers who have previously been vaccinated with the same concentration of rF1V~     vaccine.~   "
263667|NCT00097383|"~     This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in~     combination for locally advanced or metastatic breast cancer. Epirubicin is a~     well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been~     combined with other drugs but they have not yet been combined with each other. It is expected~     that the patient will benefit from the different mechanisms of action of the two drugs.~   "
263668|NCT00097370|"~     This is an open label study of mepolizumab 750 mg intravenous in those subjects who~     participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in~     subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing~     frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs~     and symptoms of Hypereosinophilic Syndrome.~   "
263669|NCT00097357|"~     The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and~     lungs in men and women following unilateral total knee replacement surgery. The safety of~     this treatment will also be studied.~   "
263670|NCT00097344|"~     The purpose of this study is to determine whether maximal estrogen suppression achieved via~     the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene~     (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying~     the growth of breast cancer, and whether the side effects of the combined hormonal therapy~     are different from the side effects of letrozole.~   "
263671|NCT00097331|"~     The study will evaluate the effectiveness and safety of the investigational drug SB683699 in~     treating patients with relapsing multiple sclerosis (MS), using data from magnetic resonance~     imaging (MRI) scans as the main measure.~   "
263672|NCT00097318|"~     This study will examine the safety of the drug interferon beta 1a in patients with acute~     ischemic stroke to determine the highest dose patients can tolerate without serious side~     effects and to determine the best way to give the medication. Ischemic stroke is caused by a~     blood clot blocking the flow of blood to brain tissue, causing loss or impairment of bodily~     functions governed by the affected part of the brain. Interferon beta 1a is approved for use~     in patients with multiple sclerosis to prevent further brain injury caused by inflammation;~     the drug may also help prevent further brain injury in patients with acute stroke.~      Patients between 18 and 85 years of age who have had a stroke and who can begin taking the~     study drug within 24 hours of onset of stroke symptoms may be eligible for this study.~     Candidates are screened with a medical history, physical examination and neurological~     examinations, blood tests, electrocardiogram, and brain imaging with magnetic resonance~     imaging (MRI) or computed tomography (CT) scans.~      Participants are randomly assigned to receive either interferon beta 1a or placebo (an~     inactive substance). For every five patients enrolled, four receive the study drug and one~     receives placebo. The dose of interferon beta 1a is increased in successive groups of~     patients, so that the first group to enter the study receives 11 micrograms (mcg) of the~     drug, the next receives 22 mcg, then 44 mcg, 66 mcg, and 88 mcg. All patients receive their~     first dose intravenously (through a vein); additional doses are given subcutaneously (under~     the skin).~      During their hospital stay all participants receive standard medical care for stroke, have~     neurological checks every 6 hours, and have continuous heart monitoring. To prevent fever,~     they receive medication, such as Tylenol, before each dose of interferon beta 1a or placebo~     and every 6 hours as needed while taking the study drug. Routine blood tests are done at 3~     and 7 days after the first dose of study drug (or at discharge if the patient leaves the~     hospital before 7 days) and again at 14, 21, and 28 days. Neurological examinations are done~     24 hours after starting the study medication, then every day for 14 days, and again on day~     28.~      After discharge from the hospital, patients are seen by a nurse every day foan 14 days after~     the first medication dose. They are contacted by phone on days 17 and 21. On day 28 they~     return to the hospital as an outpatient for a neurological assessment and blood tests.~   "
263673|NCT00097305|"~     The purpose of this study is to examine and compare the effects of two body therapy~     approaches in women who have experienced child sexual abuse.~   "
263674|NCT00097292|"~     RATIONALE~      The accrual of data from the laboratory and from epidemiologic and prevention trials has~     improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus~     (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and~     characterization of the early metabolic abnormalities in T1DM is steadily increasing.~     However, information regarding the natural history of T1DM remains incomplete. The TrialNet~     Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been~     designed to clarify this picture, and in so doing, will contribute to the development and~     implementation of studies aimed at prevention of and early treatment in T1DM.~      Purpose:~      TrialNet is an international network dedicated to the study, prevention, and early treatment~     of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland,~     United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to~     testing new approaches to the prevention of and early intervention for type 1 diabetes.~      The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to~     enhance our understanding of the demographic, immunologic, and metabolic characteristics of~     individuals at risk for developing type 1 diabetes.~      The Natural History Study will screen relatives of people with type 1 diabetes to identify~     those at risk for developing the disease. Relatives of people with type 1 diabetes have about~     a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet~     will identify adults and children at risk for developing diabetes by testing for the presence~     of these antibodies in the blood. A positive antibody test is an early indication that damage~     to insulin-secreting cells may have begun. If this test is positive, additional testing will~     be offered to determine the likelihood that a person may develop diabetes. Individuals with~     antibodies will be offered the opportunity for further testing to determine their risk of~     developing diabetes over the next 5 years and to receive close monitoring for the development~     of diabetes.~   "
263675|NCT00097279|"~     This trial is conducted in the United States of America (USA). The purpose of this study is~     to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative~     in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for~     the control of blood glucose.~   "
263676|NCT00097266|"~     The purpose of this research study is to confirm the safety and effectiveness of aripiprazole~     therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.~   "
263677|NCT00097253|"~     The purpose of this study is to examine the body's response to relaxing and stimulating~     fragrances commonly used in aromatherapy.~   "
263678|NCT00097240|"~     The Raptiva Pregnancy Registry was a prospective observational study established to obtain~     data on pregnancy outcomes of women who were exposed to Raptiva.~   "
263679|NCT00097227|"~     The purpose of the study is to determine if the combination of cetuximab, carboplatin and~     paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer~     (NSCLC). The safety of this combination will also be evaluated.~   "
263680|NCT00097214|"~     This is a phase II study in previously untreated subjects with histologically or~     cytologically proven stage IIIB/IV NSCLC designed to determine the efficacy of first line~     treatment with carboplatin and cetuximab.~   "
263681|NCT00097188|"~     This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicenter~     study to evaluate the safety and efficacy of Rituximab in adults with RRMS.~   "
263837|NCT00095069|"~     The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with~     insomnia.~   "
263682|NCT00097175|"~     This study will investigate how the brain process emotions in healthy people and in patients~     who have major depression in order to better understand the causes of depression. It will~     examine what happens in the brain when a person responds to words related to different~     emotions while the brain's ability to manufacture a chemical called serotonin is reduced.~     Serotonin regulates functions such as emotion, anxiety and sleep, and stress hormones such as~     cortisol. In this study, participants' serotonin levels are reduced by depleting tryptophan,~     an amino acid that is the main building block for serotonin.~      Healthy volunteers and patients with major depression that has been in remission for at least~     3 months may be eligible for this study. Candidates must be between 18 and 50 years of age~     and right-handed. They are interviewed about their medical and psychiatric history, current~     emotional state and sleep pattern, and family history of psychiatric disorders. Screening~     also includes psychiatric interviews and rating scales, neuropsychological tests, physical~     examination, electrocardiogram (EKG), and blood, urine, and saliva tests. Women have their~     menstrual phase determined by a blood test and home urine ovulation test kit.~      The study involves two clinic visits in which participants undergo tryptophan depletion and~     magnetic resonance imaging (MRI). Subjects arrive at the NIH Clinical Center in the morning~     after fasting overnight. They fill out questionnaires have a blood sample drawn, and then~     take 74 capsules that contain a mixture of amino acids found in the diet. At one visit they~     are given capsules that contain a balanced mixture of amino acids one would normally eat in a~     day; at the other visit, some of the capsules contain lactose instead of tryptophan, causing~     tryptophan depletion. At 2 p.m. participants fill out the same questionnaires they completed~     at the beginning of the day and have another blood sample drawn. Then they do a computerized~     test in the MRI scanner. MRI uses a magnet and radio waves to obtain pictures of the brain.~     For the test, subjects lie on a narrow bed that slides into the cylindrical MRI scanner. They~     are asked to press a button in response to words associated with different emotions that~     appear on a screen. Arterial spin labeling - a test that uses magnetism to measure blood flow~     in different areas of the brain-is also done during the procedure. After the scan, subjects~     eat a meal and then return home.~      DNA from the participants' blood samples is also examined to try to better understand the~     genetic causes of depression. Some of the white cells from the samples may also be grown in~     the laboratory so that additional studies can be done later.~   "
263683|NCT00097162|"~     This study will examine whether direct current (DC) polarization (electrical stimulation) of~     the visual cortex can cause a temporary improvement of vision in an amblyopic eye of an~     adult. Amblyopia (also called lazy eye) is reduced vision in an eye, caused by abnormal brain~     processing of visual information. In amblyopia, the visual cortex (the part of the brain that~     processes visual information) favors the other eye and suppresses the image from the~     amblyopic eye.~      Amblyopia in children is treated by patching or blurring the good eye, which forces the child~     to use the amblyopic eye and overcome suppression by the brain. This treatment only works in~     children 8 years old and younger, however. Electrical stimulation of the brain can~     temporarily change the function of the visual cortex in adults with good vision, but its~     influence on the visual function of people with amblyopia is unknown. If DC polarization can~     improve vision in amblyopic eyes in adults, it would show that the visual cortex is still~     plastic, and it might help researchers develop a treatment for adults with amblyopia in the~     future.~      Patients 18 years of age and older with amblyopia caused by crossing in or turning out of the~     eyes in childhood or by a difference in near- or farsightedness between the eyes may be~     eligible for this study. Candidates are screened with a medical history and complete eye~     examination, including a glaucoma screening and checks of vision, in- or out-turning of the~     eyes, depth perception, need for glasses, and the interior structures of the eyes.~      Participants undergo two study sessions, scheduled at least 24 hours apart, involving the~     following procedures:~        -  Examination: Before each session, the patients' distance vision, contrast sensitivity~          (ability to see fading letters), and ability to read small print are checked in both~          eyes.~        -  DC polarization: Patients receive either 20 minutes of electrical stimulation or 20~          minutes of sham stimulation (each patient will receive both electrical and sham~          stimulation on different days).~        -  Repeat examination: Immediately after the stimulation and again 20 minutes later,~          patients undergo repeat visual function testing. Those who show any differences in~          visual function 20 minutes after the stimulation are examined again 1 hour after the~          stimulation. Patients in whom the effect continues after 1 hour are examined again after~          1 week.~   "
263684|NCT00097149|"~     Cleft lip and palate are a significant component of morbid human birth defects in the~     developing world. This study measures the impact of having a child born with a cleft lip on~     subsequent maternal/infant family health, and whether frequent pediatric care compared to~     standard pediatric care will reduce neonatal mortality in children born with cleft lip and~     palate.~   "
263685|NCT00097123|"~     Death rates for pregnant women in rural India are approximately forty-five times higher than~     in the United States. Bleeding after the birth of a child and underlying anemia are the~     primary causes of mothers' deaths and sickness in rural India. This study assesses the~     effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the~     incidence of maternal bleeding following births assisted by midwives in selected sites in~     Belgaum District, Karnataka, India.~   "
263686|NCT00097110|"~     The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those~     reported for upper income countries. This study tests the likelihood that the joint~     administration of antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the~     incidence of preeclampsia among chronically hypertensive pregnant patients and patients with~     a past history of preeclampsia/eclampsia.~   "
263687|NCT00097097|"~     Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two~     cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential~     Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal~     care education of health care providers (Essential Newborn Care Program) results in reduced~     mortality due to perinatal asphyxia.~   "
263688|NCT00097084|"~     This trial is conducted in Europe and the United States of America (USA). The purpose of this~     study is to test whether insulin detemir is a safe and at least as effective alternative to~     insulin glargine for the control of blood glucose in basal/bolus therapy in patients with~     type 2 diabetes.~   "
263689|NCT00097071|"~     This trial is conducted in the United States of America (USA). It is demonstrated that~     intensive insulin therapy resulting in good glycaemic control can reduce or delay the~     incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an~     ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin~     injection (CSII) therapy in the pediatric and adolescent age population. This trial compares~     the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered~     by CSII in children and adolescents with type 1 diabetes.~   "
263690|NCT00097058|"~     This study is designed to assess the effects of estrogen therapy among postmenopausal women~     at risk for cognitive decline.~   "
263691|NCT00097045|"~     This study is designed to compare the safety, tolerability and antiviral effects of omega~     interferon administered alone to omega interferon administered with ribavirin in the~     treatment of subjects with chronic Hepatitis C virus (HCV) infection.~   "
263692|NCT00097032|"~     The purpose of this study is to determine whether the sedating (causing sleepiness) effects~     of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize,~     remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.~   "
263693|NCT00097019|"~     This is an open-label, single-arm, two-stage, multicenter Phase II study evaluating the~     efficacy and safety of bevacizumab in women with platinum resistant, advanced (Stage III or~     IV) EOC (epithelial ovarian cancer) or PPC (primary peritoneal cancer) that subsequently~     progressed either during treatment with Doxil or Hycamtin therapy or within 3 months of~     discontinuing treatment with Doxil or Hycamtin therapy.~   "
275369|NCT00000285|"~     The purpose of this study is to determine the effects of phenytoin on the self-administration~     of smoked cocaine.~   "
263695|NCT00096993|"~     This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial~     of pertuzumab in combination with gemcitabine relative to placebo in combination with~     gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer~     that is resistant to platinum-based chemotherapy.~   "
263696|NCT00096980|"~     This study is an open label, randomized, multicenter study designed to compare the efficacy~     of 12 weeks of subcutaneously administered efalizumab (monotherapy) with that of combination~     therapy (Efalizumab and a topical corticosteroid ointment) in subjects with moderate to~     severe plaque psoriasis who are candidates for systemic therapy. The study will also evaluate~     the safety and tolerability of 30 months of continuous efalizumab treatment in those subjects~     who derive benefit from the initial 12 weeks of treatment.~   "
263697|NCT00096967|"~     This is a multicenter, open-label extension study. Subjects who have received rhuMAb VEGF~     therapy in Study AVF2107g, AVF2119g, or AVF2192g and who completed the parent study are~     eligible for inclusion in this trial. Subjects who have received placebo in Study AVF2107g or~     AVF2192g are also eligible.~   "
263698|NCT00096954|"~     This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study~     that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had~     elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1~     second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other~     controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor~     antagonist [LTRA], or immunotherapy).~   "
263699|NCT00096941|"~     This is a multicenter, open label extension study. Subjects who have completed treatment in~     the parent study of pertuzumab, either alone or with a combination agent, and who received at~     least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if~     they are continuing to receive clinical benefit.~   "
263700|NCT00096928|"~     This was a multicenter, prospective, 5-year surveillance study of approximately 5000~     Raptiva-treated patients and approximately 500 non-Raptiva treated patients (formerly 2500~     comparison patients who were treated with a biologic therapy other than Raptiva) with chronic~     moderate to severe plaque psoriasis who were candidates for treatment with Raptiva.~   "
263701|NCT00096915|"~     The proposed study is designed to test a novel dosing paradigm that would facilitate the~     treatment of anemia in CKD patients on dialysis. Anemic patients on hemo and peritoneal~     dialysis who have achieved and maintained target hemoglobin (Hb) on every other week (Q2W)~     dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM)~     dosing.~   "
263702|NCT00096902|"~     This study will examine whether certain procedures that do not involve the use of medications~     can reduce symptoms of neurocardiogenic syncope (SIN-ku-pe), or a condition involving~     recurrent fainting. This condition is also known as vasovagal syncope or neurally mediated~     hypotension. Neurocardiogenic syncope is a disorder of the autonomic nervous system, which~     controls automatic body functions such as blood pressure, heart rate, and sweating. That~     system can be affected by medications, conditions of the mind or body, and by a person's~     surroundings. Researchers in this study wish to learn whether hypnosis, hand exercises,~     education, or diary keeping can affect the autonomic nervous system and improve symptoms of~     neurocardiogenic syncope.~      Patients age 18 or older who have neurocardiogenic syncope may be eligible for this study.~     Those who have a medical illness making it unsafe to participate, who cannot discontinue~     certain medications, or who are pregnant are not eligible. Patients will undergo a medical~     history and physical examination, complete a questionnaire, and experience Valsalva and tilt~     table tests. These tests will take about 5 hours during 1 to 2 days.~      The Valsalva test evaluates some of the reflexes of autonomic nervous system. Patients will~     lie flat on a padded table and have sensors placed on the body, to measure blood pressure,~     breathing rate, and other functions. They will blow into a sterile tube for 12 seconds while~     the body's responses are measured. The procedure may need to be repeated several times.~     During the test, an intravenous tube, guided by a needle, will be placed in the patient's~     arm. The tube will be used to collect samples of blood (less than 7 tablespoons) to measure~     chemicals such as adrenaline. For the tilt table test, a patient will lie on a padded,~     motorized table and have sensors placed on the body. Velcro straps will be placed around the~     patient's body to help hold him/her on the table. Then the table will tilt the patient from a~     flat position to an upright one in about 10 seconds. The patient will stay upright for 45~     minutes while symptoms are monitored, measurements are taken, and blood samples are collected~     through the intravenous tube. Then the table will be returned to the flat position. If the~     patient faints or is about to faint, or if he or she has an unsafe heart rhythm before the 45~     minutes is over, the test will be stopped and the table will be returned to the flat~     position. Symptoms will be treated as needed.~      Patients who qualify for further study will then become familiar with hypnosis and be~     evaluated for their natural ability for experiencing it. A professionally trained doctor will~     guide patients into a hypnotic state, and patients will be asked to respond to various~     suggestions. They will be videotaped, an activity that will require a separate consent form.~     Following these procedures, patients will be assigned to one of the four groups in this~     study. Those in the hypnosis group will have weekly sessions for 6 weeks, with each session~     lasting about 1-1/2 hours. The education group will meet a study investigator for learning~     about syncope and the autonomic nervous system, with each session lasting about 1-1/2 hours~     once a week for 6 weeks. The hand exercise group will be taught certain hand exercises to~     perform, at home and as instructed, for 6 weeks. The diary group will receive instructions on~     keeping a diary pertaining to their condition, at home, for 6 weeks. After 6 weeks, patients~     will return for an evaluation to include completion of questionnaires and another tilt table~     test and blood collection by intravenous tube. This entire study will take about 8 weeks.~     There may be direct benefits from participating in this study. The experimental procedures~     may help patients' neurocardiogenic syncope.~      After completing this study, patients will be offered any or all of the experimental~     procedures tested in this study upon their request and at the discretion of the principal~     investigator. For example, a patient who is assigned to the diary group may be offered~     hypnosis, education, and hand exercise instruction after completion of the study.~   "
263703|NCT00096876|"~     In this study, individuals complete and return a mail survey, specifically a 40 item scratch~     and sniff smell test.~   "
263704|NCT00096863|"~     Delirium is associated with increased risk of death, prolonged stay, higher cost of care, and~     likely long-term brain deficits in survivors. This form of brain dysfunction occurs in~     intensive care unit (ICU) patients in epidemic proportions, and the scope of this problem is~     likely to worsen in upcoming years due to the aging of our population and increased~     utilization of the ICU. Currently, delirium goes unrecognized and untreated in the vast~     majority of circumstances in the ICU unless the patient presents with hyperactive delirium~     and agitation. In the latter circumstance, a commonly used typical antipsychotic called~     haloperidol is considered the principal agent for treating delirium based largely on~     anecdotal evidence to support its usefulness, though no placebo controlled trials exist.~     There are no FDA approved medications for delirium. The atypical antipsychotics provide a~     promising alternative for the treatment of delirium due to their enhanced beneficial effects~     on positive (agitated) and negative (quiet) symptoms proven in mania and schizophrenia,~     reduced risk for side effects common to haloperidol such as extrapyramidal symptomatology,~     and less potentially lethal heart rhythm disturbances. It is imperative that well-designed~     phase II studies to determine proof of principle be conducted. A pilot study of feasibility~     to begin assessing the role of antipsychotics in the management of ICU delirium.~   "
263705|NCT00096850|"~     Rifampin (RIF) is used for the treatment of tuberculosis (TB), an infectious disease that~     affects many people with HIV. RIF was shown to lower concentrations and decrease the~     effectiveness of some anti-HIV drugs, including the HIV protease inhibitor (PI) atazanavir~     (ATV) boosted with ritonavir (RTV). The purpose of this study is to determine the~     interactions between RTV-boosted ATV and evaluate the safety and tolerability of giving these~     drugs together in HIV uninfected adults.~   "
263706|NCT00096837|"~     The purpose of the study is to determine if the drug motexafin gadolinium will be an~     effective treatment for patients who have relapsed or refractory multiple myeloma.~   "
263707|NCT00096824|"~     The purpose of this study is to determine how often dementia and other neurological problems~     occur in people with HIV. Participants of ACTG A5175 will enroll in this study.~   "
263708|NCT00096811|"~     The purpose of this clinical research study is to provide entecavir to subjects with chronic~     Hepatitis B infection who have failed or who have demonstrated intolerance of marketed~     therapies or for those in whom use of these agents is contraindicated and that have no other~     available treatment options.~   "
263709|NCT00096798|"~     The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid~     (ethyl-EPA), an omega-3 fatty acid, in treating depression.~   "
263710|NCT00096785|"~     The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV)~     compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an~     antiviral medicine.~   "
263711|NCT00096772|"~     The purpose of this study is to collect blood samples from HIV infected individuals for use~     in future genetic studies.~   "
263712|NCT00096759|"~     The purpose of this study is to compare the effectiveness of relaxation therapy and tai chi~     in treating the symptoms of rheumatoid arthritis (RA).~   "
263713|NCT00096746|"~     This study will compare the response of subjects who failed a first-line ATV-containing~     regimen and who have the 150L-containing virus to subsequent protease inhibitor~     (PI)-containing therapy with that of a cohort who has failed a first-line reverse~     transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.~   "
263900|NCT00094211|"~     The purpose of this study is to investigate whether seniors living in neighborhoods that are~     conducive to walking are more physically active than those living in neighborhoods that are~     less conducive to walking.~   "
263714|NCT00096733|"~     There are two principal purposes of this study: 1) to determine whether it is more beneficial~     for a liver transplant recipient candidate to pursue a living donor liver transplant (LDLT)~     or wait for a deceased donor liver transplant (DDLT), and 2) to study the impact of liver~     donation on the donor's health and quality of life.~   "
263715|NCT00096720|"~     Study participants who have been clinically diagnosed with Parkinson disease will receive no~     treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12~     weeks. Over the course of the study subjects will travel to the Institute for~     Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.~   "
263716|NCT00096707|"~     The objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and~     biologic effect (FDG PET, preliminary efficacy) of daily oral doses of 2DG with and without~     weekly docetaxel in subjects with advanced solid tumors.~   "
263717|NCT00096694|"~     Oral contraceptives (OCs) are not a good option for some HIV infected women because of the~     potential for drug interactions between OCs and anti-HIV drugs; additionally, OCs may~     increase the risk of transmitting HIV to sexual partners. Levonorgestrel is commonly~     prescribed as part of a combination OC. An intrauterine device (IUD) is a device inserted in~     a woman's uterus to prevent pregnancy. The purpose of this study is to determine the effect~     of a levonorgestrel-releasing IUD on the amount of HIV present in an HIV infected woman's~     cervix after 4 weeks of IUD use.~      Study hypothesis: There will be no increase in genital tract HIV RNA and DNA after placement~     of the levonorgestrel IUD.~   "
263718|NCT00096681|"~     The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in~     individuals 15 years and older in the Masiphumelele township of Cape Town, South Africa. Data~     collected in this study will be used to predict the effect of introducing anti-HIV therapy in~     this community.~   "
263719|NCT00096668|"~     This is an open label study where each patient will receive TOCOSOL(R) Paclitaxel 120mg/m2~     every week for first line treatment of metastatic breast cancer. Patients will be followed to~     determine the efficacy of treatment (as measured by objective response rate), and the safety~     associated with weekly administration of TOCOSOL Paclitaxel.~   "
263720|NCT00096655|"~     The purpose of this study is to evaluate the effectiveness and safety of infliximab~     (Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific~     proteins in the body's immune system to help control the development of inflammation to help~     reduce painful disease.~   "
263721|NCT00096642|"~     Depression is a debilitating illness affecting large numbers of young people. In this study,~     children and adolescents ages 10 to 17 meeting criteria for clinical depression will~     participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches~     strategies for overcoming depressed mood. For half the participants, their parents will also~     participate in a parent group. By studying the role of parental involvement, we hope to~     develop more effective treatments for depressed children and teens in the future.~   "
263722|NCT00096629|"~     RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor~     cells.~      PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine~     therapy in treating patients with kidney cancer.~   "
263723|NCT00096616|"~     The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled~     Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.~   "
263724|NCT00096603|"~     This is an open label, multicenter study designed to evaluate the safety and tolerability of~     efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with plaque~     psoriasis who previously participated in Study ACD2600g.~   "
263725|NCT00096590|"~     RATIONALE: A test that detects abnormal blood clotting in patients with cancer may help~     doctors plan cancer surgery.~      PURPOSE: This laboratory study is looking at a new blood test to detect abnormal clotting in~     patients with metastatic cancer undergoing surgery.~   "
263726|NCT00096564|"~     Objectives: The purpose of this study is to identify areas of brain activation during the~     urge to yawn. Little is known about how yawning is suppressed, or why yawning often occurs in~     response to seeing another person yawn (contagious yawning). Contagious yawning is similar to~     other contagious motor programs, such as the greater urge Tourette subjects feel to tic when~     seeing repetitive movements or other subjects' tics, the urge to scratch when discussing~     itching and scratching, or the urge to urinate when hearing running water. Hypothetically,~     the urge or the suppression of this urge is modulated by a common cortical circuit implicated~     in Tourette syndrome. We plan to use functional magnetic resonance imaging (fMRI) to identify~     the pattern of blood oxygenation level-dependent (BOLD) activation in the brain when normal~     volunteers feel the urge to yawn.~      Study Population: We intend to study 25 normal, right-handed, healthy volunteers.~      Study Design: Using an event-related design, we will scan subjects, using the same 3T fMRI~     scanner, while showing a video of a person yawning, gaping, coughing, or doing nothing. Each~     of these four action stimuli will last for four seconds, with varying interstimulus~     intervals. Each video set will contain all actions displayed ten times pseudorandomly. Two~     data sets will be collected from each subject and will be separated by a brief rest period.~     Subjects will be instructed before the scan to watch a videotaped person perform various~     behaviors, without detailing the specific actions. So as not to influence their natural~     response to the yawning stimulus, we will instruct them only to keep their head still. The~     variable of interest will be the activation during urge-generation, contrasted with other~     control stimuli. A survey will be administered for informational purposes following the scan~     to assess the subjects' general impression of their susceptibility to yawning, whether they~     yawned in the scanner, whether they suppressed the urge to yawn, and if the urge to yawn~     increased or decreased with the repetition of the yawning segment.~      Outcome Measures: The primary outcome of this study is the activation of brain structures in~     response to viewing another person yawning. In particular, we are interested in the~     activation of the anterior cingulate cortex, parietal operculum, insula, supplementary motor~     area, and dorsolateral prefrontal cortex as these are areas implicated in the urge to move in~     response to either internal (as in Tourette syndrome) or external (as in itching from~     histamine injection) states. Since the urge to yawn is the process of interest, suppression~     of yawning is not relevant to the fMRI analysis.~   "
263740|NCT00096382|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Biological therapies, such as cellular~     adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor~     cells from growing. Autologous stem cell transplant may be able to replace immune cells that~     were destroyed by chemotherapy and radiation therapy. Interleukin-2 may stimulate a person's~     lymphocytes to kill tumor cells. Combining chemotherapy, radiation therapy, and biological~     therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine~     together with radiation therapy followed by cellular adoptive immunotherapy, autologous stem~     cell transplant, and interleukin-2 works in treating patients with metastatic melanoma.~   "
263838|NCT00095056|"~     The purpose of this study is to determine the safety and tolerability of an investigational~     drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic~     Renal Insufficiency (inadequate kidney function).~   "
263727|NCT00096551|"~     Background:~        -  Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in~          patients with advanced prostate cancer.~        -  Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in~          inducing antitumor effects than the s.c. route of administration, especially when the~          recombinant rF-vector given intratumorally is preceded by a rV-recombinant given s.c.~          This may be due to:~        -  Making the tumor cell an antigen presenting cell via upregulation of both antigen~          (signal 1) and costimulatory molecules (signal 2).~        -  Making the tumor cell more susceptible to killing via upregulation of ICAM.~        -  The increased expression of perforin in peptide-specific T cells that came into contact~          with the TRICOM-infected targets.~        -  Potentially allowing the immune system to select for other tumor encoded antigens to~          generate a polyvalent immune response.~      Objectives:~        -  1: Safety and feasibility of an intraprostatic vaccine strategy.~        -  2: To assess the change in PSA-specific T-cell response as measured by ELISPOT assay.~        -  2: To evaluate T-cell infiltration histologically in patients who have pre- and~          post-vaccine prostate biopsies.~      Eligibility:~        -  Must have either a) biopsy proven, locally recurrent prostate cancer following local~          radiation as defined by the ASTRO consensus criteria as 3 consecutively rising PSA~          levels or b) have refused or not be candidates for local definitive therapy (surgery or~          radiation therapy) and have clinically progressive disease on androgen deprivation~          therapy (eg. three increases in PSA over nadir, separated by at least one week). For~          patients with previous RT, the biopsy confirming local recurrence must be done at least~          18 months after the completion of RT.~        -  Since this may also generate a systemic immune response, patients with minimal~          extraprostatic disease may be enrolled.~        -  Hepatic function: Bilirubin < 1.5 mg/dl, AST and ALT< 2.5 times upper limit of normal~      Design:~        -  Dose escalation Phase I design. Each cohort will consist of 3-6 patients, with cohorts 4~          & 5 restricted to include only HLA-A2 + patients; maximum accrual is 30~        -  Patients in all cohorts receive initial priming with rV- PSA(L155)/TRICOM and rF-GM-CSF~          s.c.~        -  The first two cohorts utilize a booster intraprostatic with dose escalation of~          rF-PSA(L155)/TRICOM.~        -  Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose~          of rF-PSA(L155)/TRICOM~        -  Last (5th) cohort u...~   "
263728|NCT00096538|"~     RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and~     may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts~     against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.~      PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients~     with classic non-HIV-associated Kaposi's sarcoma.~   "
263729|NCT00096525|"~     RATIONALE: Biological therapy such as lenalidomide use different ways to stimulate the immune~     system and stop tumor cells from growing. It may also stop the growth of tumor cells by~     stopping blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients~     with advanced or unresectable kidney cancer.~   "
263730|NCT00096512|"~     Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth. It may also stop the growth of tumor cells by stopping blood flow to the tumor. This~     phase II trial is studying how well sorafenib works in treating patients with recurrent or~     metastatic head and neck cance~   "
263731|NCT00096499|"~     Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells~     from dividing so they stop growing or die. This phase II trial is studying how well SB-715992~     works in treating patients with metastatic prostate cancer that did not respond to docetaxel~     or paclitaxel~   "
263732|NCT00096486|"~     RATIONALE: Gefitinib and everolimus may stop the growth of tumor cells by blocking the~     enzymes necessary for their growth. Giving gefitinib together with everolimus may kill more~     tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects, best way to give, and best dose~     of giving gefitinib with everolimus and to see how well it works in treating patients with~     stage IIIB or stage IV or recurrent non-small cell lung cancer.~   "
263733|NCT00096473|"~     Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to~     moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking~     abilities, activities of daily living and global function in patients. The purpose of the~     study is to further investigate the effectiveness and safety of donepezil in patients with~     severe Alzheimer's disease.~      Donepezil is thought to work in the brain by increasing the levels of an important brain~     chemical called acetylcholine. This chemical helps a person's memory to work better.~   "
263734|NCT00096460|"~     This study is designed as a Phase II/III, multi-center trial, comparing two transplant~     strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell~     Transplantation (HSCT) will improve long-term progression-free survival compared to~     autologous HSCT. Recipients will be biologically assigned to the appropriate treatment arm~     depending on the availability of a Human Leukocyte Antigen (HLA) matched sibling.~   "
263735|NCT00096447|"~     This phase II trial is studying how well lapatinib works in treating patients with recurrent~     or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking~     the enzymes necessary for their growth~   "
263736|NCT00096434|"~     This phase II trial is studying how well sorafenib works in treating patients with metastatic~     breast cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth and by stopping blood flow to the tumor.~   "
263737|NCT00096421|"~     The purpose of this study is to evaluate the impact of tight control of serum glucose levels~     with an intensive insulin treatment in patients hospitalized in an intensive care unit with~     medical and surgical patients.~   "
263738|NCT00096408|"~     The primary objective of this study is to assess disease-free survival at 4.5 years~     postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who~     are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are~     randomised to receive Total Abdominal Hysterectomy (TAH).~   "
263739|NCT00096395|"~     This phase II trial is studying how well giving sorafenib together with gemcitabine works in~     treating patients with recurrent or refractory ovarian cancer or primary peritoneal cancer.~     Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as~     gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Giving sorafenib with gemcitabine may kill more tumor cells.~   "
263741|NCT00096369|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of tamoxifen may be effective in preventing~     breast cancer.~      PURPOSE: This randomized phase II trial is studying tamoxifen to see how well it works~     compared to placebo in preventing breast cancer in women who are at increased risk for the~     disease.~   "
263742|NCT00096356|"~     RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and~     depression in women who are undergoing chemotherapy for breast cancer.~      PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving~     treatment-related fatigue in women with breast cancer.~   "
263839|NCT00095043|"~     The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.~   "
263743|NCT00096343|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy~     before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with~     carboplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin~     works in treating women who are undergoing surgery for newly diagnosed, locally advanced~     breast cancer.~   "
263744|NCT00096330|"~     RATIONALE: Chemoprevention therapy is the use of certain agents to try to prevent the~     development of cancer. The use of folic acid may be effective in preventing colorectal~     cancer. Eating a diet rich in folic acid may prevent the development of colorectal cancer.~      PURPOSE: This randomized phase I trial is studying how well a folate-depleted diet works~     compared to a folate-supplemented diet in preventing colorectal cancer in patients who are at~     high risk for developing colorectal cancer.~   "
263745|NCT00096317|"~     RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Giving~     ixabepilone with ketoconazole may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving~     ixabepilone together with ketoconazole and to see how well they work in treating patients~     with advanced solid tumors.~   "
263746|NCT00096304|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin and docetaxel, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one~     drug may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when~     given with docetaxel in treating patients with metastatic prostate cancer.~   "
263747|NCT00096291|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and paclitaxel, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy~     before and after surgery may shrink the tumor so it can be removed and may kill any tumor~     cells remaining after surgery.~      PURPOSE: This randomized phase II trial is comparing two different regimens of doxorubicin~     and paclitaxel to see how well they work in treating women who are undergoing surgery for~     breast cancer.~   "
263748|NCT00096278|"~     This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil~     together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and~     fluorouracil alone in treating patients who have undergone surgery for stage II or stage III~     colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,~     work in different ways to stop tumor cells from dividing so they stop growing or die.~     Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also~     stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy~     together with bevacizumab may kill more tumor cells. It is not yet known whether treatment~     with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab~     in treating patients who have undergone surgery for colon cancer.~   "
263749|NCT00096265|"~     This randomized phase III trial is studying whole-brain radiation therapy and stereotactic~     radiosurgery with or without temozolomide or erlotinib to see how well they work compared to~     whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain~     metastases secondary to non-small cell lung cancer. Radiation therapy uses high-energy x-rays~     to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the~     tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop tumor cells from dividing so they stop growing~     or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth and by blocking blood flow to the tumor. It is not yet known whether radiation~     therapy and stereotactic radiosurgery are more effective with or without temozolomide or~     erlotinib in treating brain metastases.~   "
263750|NCT00096239|"~     RATIONALE: CP-547,632 may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth and by stopping blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well CP-547,632 works in treating patients with~     recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.~   "
263751|NCT00096226|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with~     radiation therapy before surgery may shrink the tumor so that it can be removed. Giving~     chemotherapy after surgery may kill any tumor cells remaining after surgery.~      PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together~     with radiation therapy works in treating patients who are undergoing surgery for stage III~     non-small cell lung cancer.~   "
263752|NCT00096213|"~     RATIONALE: Intralesional resection is a less invasive type of surgery for chondrosarcoma of~     the bone and may have fewer side effects and improve recovery.~      PURPOSE: This phase II trial is studying how well intralesional resection works in treating~     patients with low-grade chondrosarcoma of the bone.~   "
263753|NCT00096200|"~     Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as~     paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they~     stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells.~     This randomized phase II trial is studying how well giving sorafenib together with paclitaxel~     and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal~     cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).~   "
263754|NCT00096187|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to~     stop tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating~     patients with recurrent or persistent low-risk gestational trophoblastic tumor after a molar~     pregnancy.~   "
263833|NCT00095121|"~     The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for~     the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18~     years) following 48 weeks of placebo-controlled, double-blind treatment and following an~     additional 192 weeks of open-label adefovir dipivoxil treatment.~   "
263755|NCT00096174|"~     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy.~     Giving monoclonal antibody therapy together with chemoradiotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together~     with radiation therapy works in treating patients with locally advanced or regional stage IV~     head and neck cancer that cannot be removed by surgery.~   "
263756|NCT00096161|"~     This phase II trial studies pentostatin and donor lymphocyte infusion in preventing graft~     rejection in patients who have undergone donor stem cell transplant. Giving pentostatin and~     an infusion of the donor's T cells (donor lymphocyte infusion) after a donor stem cell~     transplant may stop the patient's immune system from rejecting the donor's stem cells. The~     donated stem cells may replace the patient's immune cells and help destroy any remaining~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving pentostatin before donor~     lymphocyte infusion may stop this from happening.~   "
263757|NCT00096148|"~     Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop~     cancer cells from dividing so they stop growing or die. Bevacizumab may stop the growth of~     cancer by stopping blood flow to the leukemic cells in the bone marrow. Giving idarubicin and~     cytarabine with bevacizumab may kill more cancer cells. It is not yet know whether giving~     idarubicin together with cytarabine is more effective with or without bevacizumab in treating~     acute myeloid leukemia. This randomized phase II trial is studying how well giving idarubicin~     and cytarabine together with bevacizumab works compared to idarubicin and cytarabine alone in~     treating patients with newly diagnosed acute myeloid leukemia~   "
263758|NCT00096135|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     cancer cells. Giving combination chemotherapy together with radiation therapy may kill more~     cancer cells.~      PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation~     therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the~     CNS and/or testes.~   "
263759|NCT00096122|"~     This phase I/II trial is studying the side effects and best dose of tipifarnib when given~     with idarubicin and cytarabine and to see how well it works in treating patients with newly~     diagnosed myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy,~     such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing~     so they stop growing or die. Tipifarnib (Zarnestra) may stop the growth of cancer cells by~     blocking the enzymes necessary for their growth. Giving idarubicin and cytarabine with~     tipifarnib may kill more cancer cells.~   "
263760|NCT00096109|"~     This phase II trial is studying how well tanespimycin works in treating women with refractory~     locally advanced or metastatic breast cancer. Drugs used in chemotherapy, such as~     tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing~     or die~   "
263761|NCT00096096|"~     RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for~     graft-versus-host disease caused by donor stem cell transplantation.~      PURPOSE: This phase II trial is studying how well giving tacrolimus together with~     mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who are~     undergoing donor stem cell transplantation for advanced hematologic cancer.~   "
263762|NCT00096083|"~     RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances~     directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different~     ways may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving an hepatic arterial infusion of~     melphalan together with hepatic perfusion works in treating patients with unresectable liver~     cancer.~   "
263763|NCT00096070|"~     This phase II trial is studying how well giving radiation therapy together with oxaliplatin~     and fluorouracil followed by gemcitabine works in treating patients with locally advanced,~     unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor~     cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work~     in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin~     may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy~     with chemotherapy may kill more tumor cells.~   "
263764|NCT00096057|"~     RATIONALE: Monoclonal antibodies such as HuHMFG1 can locate tumor cells and either kill them~     or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody~     HuHMFG1 in treating women with locally advanced or metastatic breast cancer.~   "
263765|NCT00096044|"~     RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the~     immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can~     locate cancer cells and either kill them or deliver cancer-killing substances to them without~     harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without~     rituximab works in treating patients with relapsed or refractory chronic lymphocytic~     leukemia.~   "
263766|NCT00096031|"~     RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by~     blocking the enzymes necessary for their growth.~      PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with~     metastatic esophageal cancer or gastroesophageal junction cancer.~   "
263767|NCT00096018|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop~     cancer cells from dividing so they stop growing or die. Biological therapies such as~     thalidomide use different ways to stimulate the immune system and stop cancer cells from~     growing. Combining fludarabine with thalidomide may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when~     given together with fludarabine and to see how well they work in treating patients with newly~     diagnosed B-cell chronic lymphocytic leukemia.~   "
263768|NCT00096005|"~     This phase I trial is studying the side effects and best dose of giving tanespimycin together~     with bortezomib in treating patients with advanced solid tumors or lymphomas. (Accrual for~     lymphoma patients closed as of 11/27/09) Drugs used in chemotherapy, such as tanespimycin,~     work in different ways to stop cancer cells from dividing so they stop growing or die.~     Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their~     growth. It may also increase the effectiveness of tanespimycin by making cancer cells more~     sensitive to the drug. Combining tanespimycin with bortezomib may kill more cancer cells.~   "
263769|NCT00095992|"~     RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with~     locally advanced, recurrent, or metastatic liver cancer.~   "
263770|NCT00095979|"~     Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells~     from dividing so they stop growing or die. This phase II trial is studying how well~     ixabepilone works in treating patients with recurrent or persistent endometrial cancer.~   "
263771|NCT00095966|"~     Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by~     blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as~     gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Giving sorafenib with gemcitabine may kill more tumor cells. This phase II trial is~     studying how well giving sorafenib together with gemcitabine works in treating patients with~     locally advanced or metastatic pancreatic cancer.~   "
263772|NCT00095953|"~     RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with~     metastatic or recurrent malignant melanoma.~   "
263773|NCT00095940|"~     This phase I/II trial studies lapatinib to see how well it works in treating young patients~     with recurrent or refractory central nervous system (CNS) tumors. Lapatinib may stop the~     growth of tumor cells by blocking the enzymes necessary for their growth.~   "
263774|NCT00095927|"~     This research study is studying a drug called Amifostine as a treatment for squamous cell~     carcinoma in the head and/or neck area.~   "
263775|NCT00095914|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways~     to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with~     ABI-007 may kill more tumor cells.~      PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with~     ABI-007 in treating patients who have locally advanced or metastatic solid tumors.~   "
263776|NCT00095901|"~     This study plans to examine the effects of Capecitabine administered as an oral chemotherapy~     drug in participants with nasopharyngeal cancer.~      Capecitabine is an oral prodrug. A prodrug is a drug that is converted within the body into~     its active form that has medical effects. Capecitabine is a prodrug of 5-fluorouracil (5-FU),~     which is a chemotherapy agent frequently used to treat head and neck cancers. Capecitabine is~     absorbed through the gastrointestinal tract and is converted to 5-FU. Capecitabine (Xeloda9)~     has been tested in subjects with colorectal and breast cancers, and shown to be effective in~     those cancers. Likewise, 5-FU has shown benefit when administered as a continuous infusion~     for those with nasopharyngeal cancers. Since Capecitabine is a prodrug of 5-FU, it is~     possible that similar results will be achieved.~      RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who~     have locally recurrent or metastatic nasopharyngeal cancer.~   "
263777|NCT00095888|"~     Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating~     patients who have refractory metastatic breast cancer. Drugs used in chemotherapy, such as~     3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop~     growing or die. Combining 3-AP with gemcitabine may kill more tumor cells~   "
263778|NCT00095875|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and~     carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy~     with radiation therapy may kill more tumor cells. It is not yet known which regimen of~     chemotherapy and radiation therapy is most effective in treating head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of~     chemotherapy and radiation therapy in treating patients who have stage III or stage IV head~     and neck cancer.~   "
263779|NCT00095862|"~     RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune~     response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa~     may interfere with the growth of tumor cells. Combining vaccine therapy with cyclophosphamide~     and interferon alfa may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with~     interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.~   "
263780|NCT00095836|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth.~      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have~     locally advanced or metastatic thyroid cancer that did not respond to iodine therapy.~   "
263781|NCT00095823|"~     This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the~     safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant~     treatment in patients with Major Depressive Disorder.~   "
263782|NCT00095810|"~     The purpose of this clinical research study is to assess the safety and tolerability of~     aripiprazole in patients with psychosis associated with Parkinson's disease.~   "
263783|NCT00095797|"~     Phase I trial to study the effectiveness of XK469R in treating patients who have refractory~     hematologic cancer. Drugs used in chemotherapy, such XK469R, work in different ways to stop~     cancer cells from dividing so they stop growing or die~   "
263834|NCT00095108|"~     This study is being done to see if an experimental drug called recombinant interleukin-21~     (rIL-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is~     safe and has any effect on these types of cancers.~   "
263784|NCT00095784|"~     This phase II trial studies the side effects and how well decitabine works in treating~     patients with myelofibrosis, a cancer of the blood system associated with fibrosis (scar~     tissue) in the bone marrow that is advanced and for which there is no standard therapy.~     Decitabine may block the actions of some proteins that are responsible for turning certain~     genes off in various cancers including myelofibrosis.~   "
263785|NCT00095771|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells and may be an effective treatment for patients with~     glioma. Drugs such as arsenic trioxide may also make the tumor cells more sensitive to~     radiation therapy. Combining arsenic trioxide with radiation therapy may kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of combining arsenic trioxide with~     radiation therapy in treating patients who have newly diagnosed gliomas.~   "
263786|NCT00095758|"~     This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the~     safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant~     treatment in patients with Major Depressive Disorder.~   "
263787|NCT00095745|"~     This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in~     outpatients with major depressive disorder who have experienced an incomplete response to an~     ongoing antidepressant trial.~   "
263788|NCT00095732|"~     The purpose of this study is to determine the most effective dose of a new enzyme therapy on~     oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic~     insufficiency.~   "
263789|NCT00095719|"~     The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole~     in acutely agitated patients diagnosed with Dementia.~   "
263790|NCT00095706|"~     The purpose of this study is to evaluate the safety and effectiveness of combined treatment~     with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with~     HER2-positive metastatic breast cancer.~   "
263791|NCT00095693|"~     Phase II trial to study the effectiveness of sorafenib tosylate in treating patients who have~     locally advanced, metastatic, or locally recurrent thyroid cancer. Sorafenib tosylate may~     stop the growth of tumor cells by blocking the enzymes necessary for their growth and by~     stopping blood flow to the tumor.~   "
263792|NCT00095680|"~     The main objective of this study is to assess the long-term effectiveness of SCIO-469 as~     monotherapy, or in combination with bortezomib in relapsed, refractory patients with multiple~     myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003 study.~   "
263793|NCT00095667|"~     Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have~     recurrent or metastatic prostate cancer.~   "
263794|NCT00095654|"~     The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset~     of type 2 diabetes.~   "
263795|NCT00095641|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Giving capecitabine after surgery may~     kill any remaining tumor cells.~      PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who~     have undergone surgery for locally recurrent or persistenthead and neck cancer.~   "
263796|NCT00095628|"~     This phase II trial is studying how well SB-715992 works in treating patients with recurrent~     or metastatic head and neck cancer. Drugs used in chemotherapy, such as SB-715992, work in~     different ways to stop tumor cells from dividing so they stop growing or die.~   "
263797|NCT00095589|"~     RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in the urine~     may improve the ability to detect bladder cancer without invasive procedures.~      PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sediment~     in the urine in detecting bladder cancer in healthy participants, participants who have~     genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.~   "
263798|NCT00095576|"~     This study will test the safety and efficacy of an investigational Human Immunodeficiency~     Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or~     control of HIV viral load in subjects who become HIV infected.~      On September 18, 2007 the Protocol V520-023 DSMB (Data & Safety Monitoring Board) reviewed~     data from a planned interim analysis. These data demonstrated that the investigational~     vaccine candidate was not effective, and all vaccinations in the study were halted.~      Participants were encouraged to continue to come to the clinic for scheduled visits and~     ongoing risk reduction counseling since the vaccine was not effective.~   "
263799|NCT00095563|"~     Phase II trial to study the effectiveness of lapatinib in treating patients who have~     recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib~     may stop the growth of tumor cells by blocking the enzymes necessary for their growth.~   "
263800|NCT00095550|"~     The purpose of this clinical research is to learn if moderate hypertension can be better~     controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients~     who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the~     study will also evaluate the safety and tolerability of the drugs.~   "
263801|NCT00095537|"~     The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is~     directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21~     days with a 7 day rest period in patients with cancer who no longer benefit from other~     commonly used treatments. The study will also test for other proteins that may be affected by~     BMS-599626; and the level of study drug in the blood will be studied.~   "
263802|NCT00095524|"~     The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on~     weight change.~   "
263803|NCT00095511|"~     The purpose of this trial is to test the safety & efficacy of aripiprazole in patients with~     Bipolar Mania for a period of at least 12 weeks.~   "
263804|NCT00095498|"~     This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in~     the treatment of Rheumatoid Arthritis (RA).~   "
263835|NCT00095095|"~     Lumbar spinal fusion is commonly performed as a last resort in patients with chronic low~     back pain caused by degenerative changes and instability of the spine. The aim of this study~     is to compare two fusion devices, which are used in spinal surgery in order to promote the~     fusion of two lumbar vertebrae.~   "
263805|NCT00095485|"~     This study will examine the changes that the move from NIH's Building 10 Clinical Center (CC)~     into the Clinical Research Center (CRC) may have on the amount of activity a person engages~     in daily, as registered by a pedometer, which measures horizontal and vertical steps. The~     investigators in this study hope to better understand the impact that the move will have had~     on one group of employees compared with the impact for other groups. Moving to a new work~     location may require physical activity that is different from what employees currently~     experience on the job. In the new location, they may be walking longer or shorter distances;~     they may also be climbing fewer or more stairs. In addition, they may need to walk more~     quickly to accomplish the same tasks. It is important to understand how the move from the CC~     to the CRC influences employees' health, well-being, and overall function. Physical measures,~     such as blood pressure, will be examined. So will how well employees are adjusting to the new~     location-for example, through information about work-related injuries.~      Clinical Center employees who are able to walk, whose move dates allow 10 days in the~     Clinical Center before the move, who wish to participate in the study and are able to wear a~     pedometer, and whose work requirements include a sufficient amount of walking may be eligible~     for the study.~      Participants will undergo the following procedures before the move into the CRC and then 1~     month after the move. Each evaluation will take about 30 minutes:~        -  Brief history about age, medical problems, and current medications.~        -  Measurements of heart rate, blood pressure, height, and weight.~        -  Completing a brief questionnaire about the history of injuries, such as back pain,~          tendonitis, and bursitis.~      In addition, participants will complete a questionnaire about daily life and leisure~     activities, consisting of 94 questions, to take about 20 minutes to complete. There will also~     be a measurement of the distance that participants can walk in 2 minutes.~      A pedometer will be provided to each participant and will remain the property of that person.~     Participants will receive a daily log on which to record the number of steps they have walked~     and the distance as registered by the pedometer. About 5 minutes a day will be needed to~     record such information. The information that participants provide will be coded. They will~     not be personally identified, nor will the information be discussed with other people,~     including supervisors or co-workers.~      Information collected will be analyzed for changes in activity patterns and will be analyzed~     by groups of staff. For example, the investigators may wish to compare the activity of nurses~     before and after the move and then compare that information with information collected from~     food service workers, or personnel serving as messengers or escorts. Participants may find~     the information gathered to be useful to them as individuals. That is, they may learn that~     their activity has increased as a result of the move to the new location. They may have~     benefited by having lost weight or lowered their blood pressure.~   "
263806|NCT00095472|"~     This study examines ways in which nitric oxide (NO), an important molecule that controls how~     blood flows through the body's vessels, might be restored with a compound called sodium~     nitrite. It is hoped that the result will reverse the effect of decreased flow of blood due~     to sickled cells-that is, cells that have changed into the shape of a crescent or sickle.~     Sickle cell disease is the most common genetic disease affecting African Americans. About 8%~     of that population has the sickle cell trait. The changed cells can become attached to blood~     vessels, decreasing blood flow to vital organs. There can be the loss of needed proteins,~     including hemoglobin, that deliver oxygen throughout the body.~      Adults at least 18 years of age who have the SS form of sickle cell disease or~     S-beta-thalassemia, are in either a steady state or crisis, give informed and written consent~     for participation, and have had a negative pregnancy test may be eligible for this study.~     Adults with any other disease that puts them at risk for reduced circulation are not~     eligible. Women who are breastfeeding are not eligible.~      Participants will undergo a medical history, including family medical history, and a detailed~     physical evaluation, to take about 1 hour. There will be a collection of blood;~     echocardiogram, which involves taking a picture of the heart and its four chambers; and~     measurement of exhaled carbon monoxide, carbon dioxide, and NO. A procedure called orthogonal~     polarization spectral imaging will be performed. A small object the size of a Popsicle stick~     will be placed under the tongue or on a fingertip. This procedure presents a picture of blood~     flow and how the red blood cells appear as they circulate through blood vessels. The study~     will be conducted in the Vascular Laboratory/Cardiovascular Floor or Intensive Care and will~     last about 4 hours.~      During the study, patients will lie in an adjustable reclining bed and chair. Small tubes~     will be placed in the artery and vein of the forearm at the inside of the elbow. A small~     pressure cuff will be applied to the wrist and a larger one to the upper arm. Both cuffs will~     be inflated with air. A strain gauge, resembling a rubber band, will go around the widest~     part of the forearm. When the pressure cuffs fill with air, blood will flow into the arm, and~     information from the strain gauge will be recorded. Between administrations of each medicine,~     there will be 30-minute rests. Normal saline will be put into the small tube in the artery.~     Measurements of the blood flow in the forearm will be taken, and a small blood sample will be~     taken to measure blood counts, proteins, and other natural body chemicals. Then a medicine~     called sodium nitroprusside, which causes blood vessels to expand and increase blood flow,~     will be placed into the forearm. It will be given at three different doses for 3 minutes~     each, with measurements recorded after each dose. Then a medicine called L-NMMA will be~     placed into the forearm. L-NMMA generally decreases local blood flow by preventing nitric~     oxide from being produced in the cells lining the blood vessels. It will be given at two~     different doses for 5 minutes each, with blood flow measured after each dose. Next, nitrite~     will be placed in the forearm at three different doses for 5 minutes each. Before and after~     nitrite is given, the researchers will measure the amount of the NO, carbon monoxide, and~     carbon dioxide that the patients breathe out. Then the procedure for administering normal~     saline, sodium nitroprusside, and L-NMMA will be repeated, as will a blood test.~      This study will not have a direct benefit for participants. However, it is hoped that the~     information gained from the study will help to develop treatment options for patients with~     sickle cell disease.~   "
263807|NCT00095459|"~     Background:~        -  BAY 43-9006 is an inhibitor of wild-type and mutant B-Raf and c-Raf kinase isoforms in~          vitro, but it also inhibits p38, c-kit, VEGFR-2 and PDGFR-Beta affecting tumor growth as~          well as possibly promoting apoptosis by events downstream of c-Raf.~        -  Bevacizumab is a humanized IgG1 monoclonal antibody (MAb) that binds all biologically~          active isoforms of human vascular endothelial growth factor (VEGF, or VEGF-A) with high~          affinity (k(d)= 1.1nM)~        -  The most common adverse events associated with bevacizumab of any severity include~          asthenia, pain, headache, hypertension, diarrhea, stomatitis, constipation, epistaxis,~          dyspnea, dermatitis and proteinuria.~        -  This Phase I trial is open to patients with all solid tumors.~      Objectives:~        -  Determine the safety and toxicity of the combination of BAY 43-9006 (Sorafenib) and~          bevacizumab.~        -  Determine estimates of biochemical changes in the Ras-Raf-MAPK and VEGF signal~          transduction pathways in tumor and stromal cells in response to treatment at the MTD, at~          least in a pilot fashion, if those changes are statistically significant.~      Eligibility:~        -  Adults with histologically documented solid tumor malignancy that is metastatic or~          unresectable and for which standard curative therapies do not exist or are no longer~          effective.~        -  Patients must be off prior chemotherapy, radiation therapy, hormonal therapy, or~          biological therapy for at least 4 weeks.~        -  All patients enrolling in cohort 2 must have at least one lesion amenable to biopsy.~        -  ECOG performance status 0 or 1 and adequate organ and marrow function.~      Design:~        -  Cohort I will receive BAY 43-9006 and bevacizumab together at the start of study in a~          dose escalation fashion.~        -  Cohort II will be randomized as to which agent they receive for cycle one. Cycles 2 and~          beyond are treated using both agents.~        -  Tumor biopsies will be obtained from patients in Cohort II before treatment, two weeks~          into mono-therapy, and two weeks into combinatorial therapy.~        -  DCE-MRI studies will be obtained on patients in Cohort II before treatment, two weeks~          into monotherapy, four weeks into monotherapy, and two weeks into combinatorial therapy.~        -  FDG-PET studies will be obtained on patients in Cohort II before treatment, two weeks~          into mono-therapy, and two weeks into combinatorial therapy.~        -  Patients will be evaluated for toxicity in clinic every 2 weeks for Cycles 1 and 2, and~          then every 4 weeks.~        -  Patients will be evaluated for response every 8 weeks using the RECIST criteria.~        -  Approximately 62 patients will be needed to achieve the objectives of the trial.~   "
263808|NCT00095446|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to~     insulin lispro, both in insulin pumps, in standard clinical practice.~   "
263809|NCT00095433|"~     This is a Phase III, open-label, multicenter extension study of intravitreally administered~     ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization~     (CNV) secondary to AMD who have completed the treatment phase of a Genentech sponsored Phase~     I or Phase I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g).~   "
263810|NCT00095420|"~     This study will determine whether peer interaction training interventions are effective in~     enhancing the social relationships of children with autism.~   "
263811|NCT00095407|"~     This study will identify the regions of the brain that are involved in personality trait~     knowledge-that is, what a person knows about aspects of personality such as generous,~     honest, and others. It will also examine brain areas relating to a person's knowledge of~     how likeable those personality traits are, being familiar with the traits, and the degree of~     associating such traits with one's self. There has not been any previous study, through~     modern imaging techniques, on the location of the brain and the concepts of personality~     traits.~      Patients ages 21 to 65 who are in good health, are right handed, and native speakers of~     English may be eligible for this study. Pregnant women are not eligible. There will be 200~     participants involved in pencil-and-paper or computer tasks. Also, there will be three~     functional magnetic resonance imaging (fMRI) experiments with 32 participants. Patients may~     participate in up to three fMRI experiments.~      Patients will be recruited through NIH's Normal Control Database. They would need to have had~     a neuroexamination conducted by an NIH doctor within the last year. Patients will be~     interviewed for any medical, neurological, or psychological condition that would make it~     difficult to read the fMRI results. Depending on the studies that patients take part in, they~     will have different questionnaires to complete. They may also perform a computerized test~     that measures word associations. These tests will take about 1 to 2 hours.~      The technique of MRI uses a strong magnetic field and radio waves to obtain images of body~     organs and tissues. During the initial MRI scan, patients will lie still on a table that will~     slide into the enclosed tunnel of the scanner. They will be in the scanner not longer than 2~     hours. During the procedure, they may be asked to lie as still as possible for up to 1 hour~     at a time. As the scanner takes pictures, patients will hear knocking or beeping sounds, and~     they will wear earplugs to reduce the noise. Patients will be able to communicate with the~     MRI staff at all times during the scan, and they may ask to be moved out of the machine at~     any time. Then the functional MRI (fMRI) scan will involve taking pictures of the brain while~     patients are performing tasks. All the tasks will be explained, and patients will have the~     chance to practice them before entering the scanner. For this activity, patients will be~     asked to make decisions about what they are seeing in the tasks presented to them. They will~     decide yes and no by pressing a left or right button. This scan will take about 1 hour.~     Afterward, patients may be asked to fill out written questionnaires or to perform reaction~     time tasks by using a computer.~      This study will not have a direct benefit for participants. However, it is hoped that~     information gained will enhance researchers' understanding about which areas of the brain are~     necessary to perform certain tasks.~   "
263812|NCT00095394|"~     The purpose of this clinical research is to learn if severe hypertension can be better~     controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients~     who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the~     study will also evaluate the safety and tolerability of the drugs.~   "
263813|NCT00095381|"~     BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their~     growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating~     patients who have recurrent or refractory advanced T-cell leukemia.~      Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every~     week for up to six courses. Patients are not required to be hospitalized for the~     administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777~     twice a week for 6 weeks.~   "
263814|NCT00095368|"~     The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP~     tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation~     will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).~   "
263815|NCT00095355|"~     This study will examine whether lithium carbonate, given alone or with divalproex, increases~     the amount of brain-derived neurotrophic factor (BDNF) in the spinal fluid of patients with~     Huntington's disease (HD), a hereditary disorder of the central nervous system. Patients with~     this fatal degenerative disease have lower amounts of substances in the brain and spinal~     fluid called trophic or growth factors. One of these factors is BDNF. A possible treatment~     for HD may be to increase the levels of BDNF. Lithium carbonate, a drug used to treat bipolar~     disorder, and divalproex, a drug used to treat mood disorders and seizure disorders, have~     both been shown to increase the amount of BDNF protein in laboratory studies.~      Patients 18 to 70 years old with a DNA-confirmed diagnosis of Huntington's disease may be~     eligible for this study. Candidates are screened with a medical history and physical~     examination, neurological evaluation, blood and urine tests, and electrocardiogram (EKG).~      Participants take lithium carbonate with and without divalproex. They also receive placebo~     (an inactive substance) for portions of the study. On the first day of the study, patients~     are given a supply of pills with instructions on how to take them. Blood pressure and pulse~     are measured, and blood and urine tests may be done. Patients are evaluated with standardized~     tests and scales for assessment of various aspects of HD.~      Patients return to the clinic once a week for follow-up evaluations, including blood and~     urine tests, physical examinations, disease assessments, and a review of medication side~     effects. Each week, they receive a new supply of medications and instructions on how to take~     them. At the end of the sixth week, they finish taking the medications.~      During the study, patients undergo three lumbar punctures (spinal taps) - at weeks 2, 4, and~     6 - to measure BDNF and various other brain chemicals. For this test, a local anesthetic is~     given and a needle is inserted in the space between the bones in the lower back where the CSF~     circulates below the spinal cord. A small amount of fluid is collected through the needle.~     The procedure generally takes from 5 to 20 minutes.~      Patients return to the clinic 2 weeks after completing the study medication for a final~     evaluation, including a physical examination and blood and urine tests.~   "
263816|NCT00095342|"~     The primary objective of this clinical research study is to compare the efficacy and the~     safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active~     Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).~   "
263817|NCT00095329|"~     The purpose of this study is to determine the safety and tolerability of the drug sirolimus~     in patients with multiple sclerosis (MS) who have failed other treatments.~   "
263818|NCT00095316|"~     Adults admitted to intensive care units are at risk for a variety of complications. One of~     the most frequent complications is the development of new infections. Infections due to a~     fungus called Candida are of particular concern. This study will test the possibility that~     caspofungin, a new therapy for fungal infections, may reduce the rate of Candida infections~     in subjects at risk.~   "
263819|NCT00095303|"~     The purpose of this study is to compare Brief Strategic Family Therapy (BSFT) for Adolescent~     Drug Abusers to treatment as usual (TAU).~      An additional follow up assessment, funded by an American Recovery & Reinvestment Act (ARRA)~     grant, was completed 5 years post randomization in order to examine the long term effects of~     outpatient treatments for illicit drug using adolescents.~   "
263820|NCT00095290|"~     Albumin in the urine is usually a signal that you might be at risk of cardiovascular~     complications. The purpose of this study is to determine if the albumin in your urine can be~     decreased by the treatment regimen that consists of irbesartan taken at the same time with~     ramipril.~   "
263821|NCT00095277|"~     The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in~     subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.~   "
263822|NCT00095264|"~     The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment~     on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).~   "
263823|NCT00095251|"~     Delirium has recently been shown as a predictor of death, increased cost, and longer length~     of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain,~     but may contribute to patients' transitioning into delirium. It is possible that modifying~     the paradigm for sedation using novel therapies targeted at different receptors, such as~     dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide~     efficacious sedation yet reduce the development, duration, and severity of acute brain~     dysfunction (delirium).~   "
263824|NCT00095238|"~     The purpose of this clinical research study is to learn if Irbesartan is superior to placebo~     in reducing mortality and cardiovascular morbidity in subjects with heart failure with~     preserved systolic function. The safety of this treatment will also be studied.~   "
263825|NCT00095225|"~     This Phase II, multicenter, randomized trial is designed to make preliminary evaluations of~     the efficacy of combining bevacizumab with chemotherapy (docetaxel or pemetrexed) or Tarceva~     relative to chemotherapy (docetaxel or pemetrexed) alone in patients with previously treated~     advanced NSCLC.~   "
263826|NCT00095212|"~     Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause~     critical reductions in physical functioning and reduced bone density. The effects of~     long-term androgen therapy on lean body mass, bone density and other clinical endpoints~     including quality of life, functional status and neurocognitive function in HIV-infected~     women are not known.~   "
263827|NCT00095199|"~     This trial is a multicenter, open-label, randomized, Phase III study in patients with~     recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial~     platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as~     chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be~     randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab &~     Pemetrexed or Pemetrexed alone; Cetuximab & Docetaxel or Docetaxel alone).~   "
263828|NCT00095186|"~     The purpose of this study is to determine if orally-administered recombinant human~     lactoferrin is effective in the treatment of advanced renal cell carcinoma (RCC) in patients~     who have failed at least one prior systemic therapy for RCC.~   "
263829|NCT00095173|"~     The primary purpose of the clinical research study is to assess the safety of treating~     children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will~     assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid~     Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence~     of disease flare.~   "
263830|NCT00095160|"~     Study 1493-852A is a phase 1 study with the primary objective of determining safety and the~     highest tolerated dose of an experimental immune response modifier administered intravenously~     to patients with solid organ tumors not responsive to currently available treatments. The~     secondary objective of the study is to monitor the tumor response to this form of treatment.~   "
263831|NCT00095147|"~     The purpose of this clinical research study is to learn if Abatacept or Infliximab in~     combination with Methotrexate demonstrate a greater reduction in disease activity over~     placebo.~   "
263832|NCT00095134|"~     The purpose of this trial is to evaluate the efficacy and safety of risperidone versus~     placebo in subjects with Major Depressive Disorder with sub-optimal response to~     antidepressant therapy.~   "
263840|NCT00095030|"~     The purpose of this clinical research study is to learn whether a muraglitazar-metformin~     combination is at least as effective as a glimepiride-metformin combination to treat type 2~     diabetics who are not sufficiently controlled with metformin alone. The safety of this~     treatment will also be studied.~   "
263841|NCT00095017|"~     The purpose of this study is to compare the effectiveness of an investigational drug versus~     placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or~     prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat~     moderate to severe pain for their bone metastases and will remain on their opioids during the~     entire course of the study.~   "
263842|NCT00095004|"~     The purpose of this study is to test the effectiveness of an approved drug in the early~     treatment of migraine.~   "
263843|NCT00094991|"~     The purpose of this study is to learn more about how muraglitazar lowers blood sugar in~     people with type 2 diabetes. The safety of this treatment will also be studied.~   "
263844|NCT00094978|"~     This study will test the safety and effectiveness of two experimental medicines -~     depsipeptide and flavopiridol - given together to treat cancers of the lung, esophagus, and~     pleura. It will determine the highest dose that these drugs can safely be given together and~     will test whether giving them together works better at shrinking tumors than giving either~     one alone.~      Patients 18 years of age and older with cancer of the lung, esophagus, or pleura, or other~     cancers that have spread to the lungs or pleura may be eligible for this study. Candidates~     are screened with a medical history and physical examination, blood tests, electrocardiogram~     (EKG), x-rays and scans, pulmonary function tests, and a tumor biopsy (removal of a small~     piece of tumor tissue for microscopic examination).~      Participants are admitted to the hospital for treatment for approximately 10 days during each~     28-day treatment cycle. Depsipeptide is infused through an arm vein or central venous~     catheter (tube placed in a large vein in the neck or chest) for 4 hours. When this infusion~     is complete, flavopiridol is infused over 72 hours. The dose of depsipeptide is increased~     four times over the period of the study with successive groups of patients, and flavopiridol~     is increased once to determine the maximum safe dose of giving these drugs together.~      Blood tests are done before and after each depsipeptide infusion and 3 more times for the~     next 24 hours, and at various times over 4 days during the flavopiridol infusion to evaluate~     the effects of the medicines. Samples are also drawn periodically throughout the treatment~     cycle to evaluate safety. Heart function is monitored with several EKGs before and during the~     depsipeptide doses. The drug has shown effects on EKG tracings, but does not appear to injure~     the heart muscle.~      Tumor biopsies are done before treatment begins and on the fifth day of the first treatment~     cycle. The biopsies may be done either in the operating room by passing a tube (bronchoscope)~     down the throat and into the lungs or in the Radiology Department using a thin needle put~     through the chest wall into the tumor. For the bronchoscopy, numbing medicine is sprayed into~     the back of the throat to reduce discomfort, and for the needle biopsy, the skin over the~     biopsy area is numbed. Optional repeat biopsies may be requested before the start of the~     second treatment cycle and on day 5 of that cycle. (The repeat biopsies are not required for~     participation in the study.) At the time of each tumor biopsy, a buccal mucosal biopsy is~     also done. This involves scraping a tongue depressor along the inside of the mouth to collect~     cells for examination.~      At the end of the first treatment cycle, patients return to NIH for evaluation with a~     physical examination, blood work, x-rays, and scans of the chest, abdomen, pelvis, and brain.~     Patients who are not experiencing significant drug side effects are offered a second cycle,~     exactly like the first. The two cycles complete one course of treatment, after which patients~     once again return to NIH for evaluation. Additional treatment cycles may be offered to~     patients whose tumors have shrunk or remained stable with therapy. Patients whose tumors have~     not responded to therapy or who have developed severe drug side effects are taken off the~     study.~   "
263845|NCT00094965|"~     This trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies~     who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal~     dysfunction) based on their baseline measured creatinine clearance then treated with FOLFOX4.~      Standard bone marrow and liver function inclusion and exclusion criteria must be met prior to~     study treatment. FOLFOX4 in the study is given every 2 weeks (1 cycle = 2 weeks) for up to 12~     cycles unless there are treatment delays to allow for recovery from toxic effects. Dose~     modifications are included for protocol specified toxicities. After 12 treatment cycles on~     study, patients who are having a beneficial disease response may continue to have oxaliplatin~     supplied off study to continue the treatment regimen until disease progression, prohibitive~     toxicity or death.~      Oxaliplatin pharmacokinetic studies (plasma and urine) are planned during cycles 1 and 2 on~     each patient. Creatinine clearance will be assessed every 2 cycles and disease status will be~     assessed every 3 cycles of treatment during the study.~   "
263846|NCT00094952|"~     The main goal of this project is to use imaging and biomarkers to identify cognitively normal~     elderly people who are at increased risk for developing mild cognitive impairment (MCI). MCI~     is the earliest clinically detectable evidence for brain changes due to Alzheimer's disease~     (AD). The second goal of this project is to describe the inter-relationships among anatomical~     biomarkers, cerebrospinal fluid biomarkers, and cognition measures in those elderly people~     who develop MCI.~   "
263847|NCT00094939|"~     The goal of this project is to develop an early diagnostic test for Alzheimer's disease (AD)~     by monitoring loss of neurons and brain size reductions over a period of five years.~   "
263848|NCT00094926|"~     The purpose of this study is to examine the safety and effectiveness of the long acting~     injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with~     treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in~     the past year.~   "
263849|NCT00094913|"~     The purpose of this study is to identify the earliest predictors of memory and brain~     deterioration in pre-clinical Alzheimer's disease using positron emission tomography (PET) to~     monitor brain glucose metabolism.~   "
263850|NCT00094900|"~     Autoinflammatory diseases are illnesses characterized by episodes of inflammation that,~     unlike autoimmune disorders, lack the production of high titer autoantibodies or~     antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1~     (IL-1) plays a pathogenic role in several of these diseases. This exploratory study aims to~     examine the utility of the experimental drug candidate, IL 1 Trap (Regeneron Pharmaceuticals,~     Inc.) in the treatment of adult subjects with the autoinflammatory disorders Neonatal Onset~     Multisystem Inflammatory Disease (NOMID), Muckle-Wells Syndrome (MWS), and Familial Cold~     Autoinflammatory Syndrome (FCAS), Familial Mediterranean Fever (FMF), and adult Still's~     disease. FMF is associated with mutations in pyrin encoding MEFV. NOMID, MWS and FCAS are~     associated with mutations in cryopyrin-encoding CIAS1.~      This pilot study is designed to address: 1) the utility of IL 1 Trap in the treatment of~     subjects with diseases known to respond to IL-1 blockade (NOMID/MWS/FCAS) as shown by~     response to treatment with anakinra [Kineret]; 2) the response to IL-1 blockade of subjects~     with Adult Still's disease and colchicine-resistant FMF once the efficacy of IL-1 Trap has~     been established in NOMID/MWS/FCAS subjects; and 3) the biochemistry and genetics of~     autoinflammatory diseases and IL-1 related inflammation.~      IL-1 Trap is a recombinant fusion protein with picomolar affinity for IL-1 and a half-life of~     approximately 7.5 days in humans. This agent is currently in Phase 2 clinical studies for the~     treatment of rheumatoid arthritis and initial studies have shown activity against clinical~     and biochemical indicators of inflammation. Compared with anakinra, this agent may exhibit~     improved dosing convenience, potential for fewer injection site reactions, and improved~     efficacy due to the extremely high affinity of IL-1Trap for its target.~      In this study, biochemical, genetic, and clinical correlates of autoinflammatory disease will~     initially be measured at baseline following a withdrawal of any TNF or IL-1 inhibitor~     medications where applicable. Subjects will receive a course of therapy with IL-1 Trap that~     is predicted to provide an estimated 3-4 weeks of anti-inflammatory activity. Clinical,~     biochemical, and genetic correlates of inflammation will be measured at appropriate intervals~     to ascertain response and to further elucidate disease mechanisms. Subjects will be eligible,~     based on clinical response, to enter a 1- year extension phase with IL-1 Trap. Those subjects~     who complete the 1-year extension phase, and maintain improved clinical and laboratory~     parameters compared to baseline values, may continue to receive study medication at their~     current dose until the study drug is commercially available.~      Investigator comment:~      This protocol (from the NIH standpoint) is a continuation of the ongoing protocol 05-AR-0014,~     with a new change in study sponsor, the NIH replacing Regeneron as sponsor. this protocol~     therefore still contains background and procedural information that refer to patients with~     FMF and FCAS and or MWS and Still's disease, however only patients with Still's disease will~     be newly enrolled from this point on, enrollment for the FCAS and or MWS patients has already~     been completed and it has been decided to not enroll any more FMF patients because the number~     of subjects is too low to reach reasonable conclusions, in addition it has been difficult to~     recruit patients that are eligible. The background section and study procedures have largely~     been left as in the currently IRB approved protocol.~   "
263851|NCT00094887|"~     This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain~     to go away in patients who are in sickle cell crisis. NO is important in regulating blood~     vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that~     line the blood vessels. It is also transported from the lungs by hemoglobin in red blood~     cells.~      Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or~     other blood problems causing sickle cell disease) may be eligible for this study. Patients~     whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood~     tests and a chest x-ray to look at the lungs and heart.~      Participants are admitted to the hospital in a pain crisis. They are evaluated and then~     randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2)~     standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes~     up most of the air we breathe and is not known to help in sickle cell disease.~      For the first 8 hours of the study, patients receive placebo or NO through a facemask. The~     mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a~     meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic~     tubing that rests under the nose) that may be taken off only while showering or using the~     restroom. Patients are questioned about the severity of their pain when they start the study~     and then every few hours while they are in the hospital. Their vital signs (temperature,~     breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas~     for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go~     home. Patients are followed up about 1 month after starting the study by a return visit to~     the hospital or by a phone call.~   "
263852|NCT00094874|"~     Acupuncture is a form of Chinese medicine that has been in existence for more than a thousand~     years. This clinical trial performs two types of acupuncture on traditional 'bladder' points~     to determine if one type demonstrates improvement over the other. In the first type needles~     stimulate acupuncture points on the skin, and in the second type the needles penetrate~     through the skin similar to how acupuncture is usually performed. The technique is done~     through shields so that people will not know what type of acupuncture they receive.~      Patients must have at least moderately severe disease as determined by a urologist. They must~     be willing not to change their medical regimen for the duration of the trial. Patients will~     receive twelve treatments over six to twelve weeks. They will be asked to fill out symptom~     questionnaires and bladder diaries at regular intervals to monitor change. All treatment is~     free of charge, and patients who complete the trial will receive a small stipend.~   "
263853|NCT00094861|"~     The purpose of this study is to determine if palifermin will reduce the incidence of~     dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation~     chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).~   "
263854|NCT00094848|"~     The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in~     subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).~   "
263870|NCT00094640|"~     The goals of this study are to:~      Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different~     points in time after an injection, and compare these levels to the amount of olanzapine in~     the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets~     or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).~   "
263871|NCT00094627|"~     The purpose of the study is to test the safety and effectiveness of the Investigational Drug~     on insomnia.~   "
263901|NCT00094198|"~     To assess interactions between selected cardiovascular medications and genes in the incidence~     of heart attack, stroke, and atrial fibrillation, an irregular heartbeat.~   "
263855|NCT00094835|"~     The purpose of this trial is: - To characterize the safety profile of motesanib when used in~     combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in~     patients with advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic~     (PK) profile of motesanib when it is used in combination with CP, with panitumumab, or with~     CP and panitumumab. - To compare the paclitaxel and motesanib PK profiles when the~     medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - To~     characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib~     with CP, motesanib with panitumumab, or motesanib with CP and panitumumab. - To describe the~     objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of~     panitumumab in patients administered motesanib with panitumumab and motesanib with CP and~     panitumumab.~   "
263856|NCT00094822|"~     The purpose of this research study is to evaluate the safety and effectiveness of Neulasta®~     (pegfilgrastim) in reducing infection when given on the same day versus one day after the~     completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or~     metastatic non-small cell lung cancer (NSCLC). This study is considered to be~     investigational because previous studies with Neulasta® used next day dosing and not same~     day dosing.~   "
263857|NCT00094809|"~     The purpose of this research study is to evaluate the safety and effectiveness of~     pegfilgrastim in reducing grade 3/4 neutropenia when given after one of three chemotherapy~     regimens (FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal~     cancer. This study is considered to be investigational because the time between receiving~     pegfilgrastim and the next cycle of chemotherapy is only 11 days.~   "
263858|NCT00094796|"~     This study will examine whether the anti-diabetes medicine rosiglitazone can safely and~     effectively reverse the early problems of type 2 diabetes and delay the onset of disease in~     people with pre-diabetes. The underlying problem in people with diabetes or pre-diabetes is~     insulin resistance (lowered sensitivity to insulin) resulting in poor glucose (sugar)~     regulation. Rosiglitazone improves the body's sensitivity to insulin.~      Patients 21 years of age and older who have type 2 diabetes or who are pre-diabetic (glucose~     intolerant/insulin resistant) may be eligible for this study. Candidates are screened with a~     medical history, physical examination, blood tests, echocardiography (heart ultrasound),~     exercise test, brachial artery reactivity test (see below), and possibly a muscle biopsy.~      Participants take one rosiglitazone tablet daily by mouth for 2 weeks. The dose is then~     increased to two tablets daily for another 2 weeks and then to 4 tablets daily for the~     remainder of the 12-week treatment period. In addition to treatment, patients undergo the~     following tests and procedures:~        -  Resting and exercise metabolic testing: The amount of oxygen taken in and carbon dioxide~          exhaled during breathing is measured while the patient rests in a chair and then while~          he or she exercises on a stationary bicycle or treadmill. Both at rest and during~          exercise, the patient wears a facemask that measures the amount of oxygen used. During~          exercise, heart rate is monitored with electrodes on the chest, arms, and thighs. The~          exercise test is repeated three times, once to become familiar with the test, again the~          next day to measure exercise capacity, and again 3 days later. The third test is less~          strenuous and is optional.~        -  Muscle biopsy (optional): A small area of skin over a calf muscle is numbed with a local~          anesthetic and a 1-inch incision is made over the muscle. A small amount of muscle~          tissue is taken and the incision is closed with stitches.~        -  Brachial reactivity study: This ultrasound study tests how well the patient's arteries~          widen. The subject rests on a bed for 30 minutes. An ultrasound measuring device is~          placed over the artery just above the elbow. The size of the artery and blood flow~          through it are measured before and after inflating a pressure cuff around the forearm.~          The pressure cuff stops the flow of blood to the arm for a few minutes. After a~          15-minute rest, a nitroglycerin tablet (medicine that causes blood vessels to relax) is~          placed under the patient's tongue. Before and 3 minutes after the nitroglycerin is~          given, the size of the artery and blood flow through it are measured again.~        -  Blood samples: Blood samples are collected at the beginning and end of the study and at~          study visits in between.~        -  Study visits: Patients come to the Clinical Center biweekly or monthly for a follow-up~          history, physical examination, and blood tests. At the end of the3-month treatment~          period, they receive recommendations about possible treatment modifications to best~          maintain glucose tolerance. Their physicians are informed of how their blood sugar was~          controlled. Six months after completing the study, patients undergo a final study~          evaluation and blood tests, and are then invited to return for yearly checkups after~          that.~   "
263859|NCT00094783|"~     This study will examine the use of magnetic resonance imaging (MRI) instead of x-rays to~     guide angioplasty in patients who require these treatments to treat blockages in leg~     arteries. Angioplasty is a procedure in which a balloon is inflated in a blocked artery to~     improve blood flow. MRI uses a magnetic field and radio waves rather than x-rays to show~     pictures of body tissues and organs. MRI shows all soft tissue, including the arteries,~     blood, and other organs, while the usual x-ray technique shows only the lumen of the artery~     when it is filled with dye, but not the vessel walls.~      Patients 18 years of age and older who require angioplasty with or without stenting to~     restore blood flow to the leg may be eligible for this study.~      Participants undergo the usual angioplasty procedure. The skin in the patient's groin area is~     numbed and a catheter is placed into the groin artery. The patient is given a blood-thinning~     medicine, and then other catheters are inserted to measure blood pressure and to inject a~     contrast dye to take pictures. Balloon catheters are inflated to open the blockage and, if~     needed, stents are put in place to maintain the opening. When the blood thinner wears off,~     the catheters are removed.~      Most of the procedure is conducted using MRI instead of X-rays to visualize the arteries and~     blockages. The patient is moved back and forth between the x-ray and MRI machines in a~     specially designed laboratory. If necessary, stenting, placement of a wire mesh to hold open~     the artery, is done using conventional x-ray techniques.~      The entire procedure, including MRI, takes up to 4 hours.~   "
263860|NCT00094770|"~     The purpose of this investigational study is to determine the safety and effectiveness of an~     investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).~   "
263861|NCT00094757|"~     The purpose of this study is to determine the safety and effectiveness of an investigational~     drug in patients with Type 2 Diabetes Mellitus.~   "
263862|NCT00094744|"~     The goals of this study are:~        -  To determine whether the visual acuity improvement obtained with part-time (6 hours)~          patching is equivalent to the visual acuity improvement obtained with full-time patching~          (all or all but one waking hour) for severe amblyopia.~        -  To develop more precise estimates than currently available for the visual acuity~          improvement that occurs during treatment of amblyopia with patching.~        -  To identify factors that may be associated with successful treatment of amblyopia with~          patching.~   "
263863|NCT00094731|"~     The purpose of this study is to determine whether classes on memory training will help older~     adults to improve or maintain their daily activities.~   "
263864|NCT00094718|"~     West Nile (WN) virus infection is an emerging disease; WN infection may lead to paralysis,~     coma, and death. The purpose of this study is to test the safety of and immune response to a~     WN vaccine in healthy adults. The vaccine is based on a live attenuated vaccine developed~     against dengue virus.~   "
263865|NCT00094705|"~     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and~     subtropical regions of the world. The purpose of this study is to test the safety of and~     immune response to a new dengue virus vaccine in healthy adults.~   "
263866|NCT00094692|"~     The goals of this study are:~        -  To determine the response rate of treatment of amblyopia in 7 to <18 year olds.~        -  To determine the frequency of recurrence of amblyopia in 7 to <18 year olds after~          discontinuation of amblyopia treatment.~   "
263867|NCT00094679|"~     The goals of this study are:~        -  To determine whether the visual acuity improvement obtained with part-time (6 hours)~          patching is equivalent to the visual acuity improvement obtained with minimal patching~          (2 hours) for moderate amblyopia.~        -  To develop more precise estimates than currently available for the visual acuity~          improvement that occurs during treatment of amblyopia with patching.~        -  To identify factors that may be associated with successful treatment of amblyopia with~          patching.~   "
263868|NCT00094666|"~     The purpose of the study is to test the safety and effectiveness of an Investigational Drug~     on insomnia in the elderly.~   "
263869|NCT00094653|"~     The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab,~     BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with~     previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated,~     as well as patient responses and time to disease progression. Eligible patients are those who~     in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or~     temozolomide, have 1) relapsed following an objective response (partial response/complete~     response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not~     tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of~     three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379~     alone, or MDX-010 in combination with MDX-1379.~   "
263872|NCT00094614|"~     The goals of this study are:~        -  To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of~          atropine versus weekend-only use of atropine.~        -  To compare the proportion of patients achieving a complete treatment response (defined~          as amblyopic eye acuity >20/25 or equal to that of the sound eye in the absence of a~          reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only~          atropine.~   "
263873|NCT00094601|"~     This study will examine how the brain chemical dopamine affects memory, reasoning, and other~     thought processes in people with Parkinson's disease with and without dementia and in healthy~     control subjects.~      Healthy normal volunteers and people with Parkinson's disease who are between 40 and 85 years~     of age may be eligible for this study. Pregnant women with Parkinson's disease and~     breastfeeding normal volunteers are excluded. Candidates are screened with a physical and~     neurological examination, blood tests, a brief mental test called the Mini Mental Status~     Examination, and other tests designed to assess memory, learning, reasoning, and other~     thought processes. Patients with Parkinson's disease also undergo a more thorough mental~     evaluation called the Mattis Dementia Rating Scale. The study requires about 15 hours over 4~     or 5 outpatient visits to NIH.~      Participants undergo two positron emission tomography (PET) scans on two separate days and a~     magnetic resonance imaging (MRI) scan, as follows:~      PET Scans~      The two PET procedures are done the same way, except one uses a radioactive tracer called~     [(18)F]DOPA and one uses a tracer called [(11)C]NNC-112. A catheter (small plastic tube) is~     placed in a vein in the subject's arm for injection of the tracer. The subject lies on the~     scanner bed and a special mask is fitted to his or her head to hold it in place during the~     procedure. Just before injecting the tracer, a 10-minute transmission scan is done of the~     head using a tracer called (68)Ge. Then, a series of scans using one of the two study tracers~     ([(18)F]DOPA or [(11)C]NNC-112 are done for about 90 minutes. About 1 hour before injection~     of the [(18)F]DOPA tracer, subjects take 200 mg of the drug carbidopa by mouth to help the~     tracer work properly. Blood pressure, breathing and heart are monitored before and after~     injection of the [(11)C]NNC-112 tracer.~      Patients with Parkinson's disease are taken off all Parkinson's medications the night before~     the [(18)F]DOPA scan and their motor function is tested the following morning before the~     scans are done, using the Unified Parkinson's Disease Rating Scale. Patients can resume all~     medications except L-DOPA (including Sinemet) after the movement test, and they can resume~     L-DOPA after the PET scan is finished.~      MRI Scan~      MRI uses a strong magnetic field and radio waves to obtain images of the brain. The subject~     lies still on a table that slides inside the scanner, a metal cylinder. They wear ear plugs~     to muffle loud knocking sounds that occur during the scanning and can communicate with the~     MRI staff at any time through an intercom.~   "
263874|NCT00094575|"~     A multi-center, randomized clinical trial that will compare endovascular repair with standard~     open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results~     as well as the cost and quality of life associated with these two strategies for AAA repair~     will be compared.~   "
263875|NCT00094562|"~     The purpose of this study is to evaluate the safety and effectiveness of fish oil supplements~     in maintaining weight in people with disease-related weight loss and/or cachexia.~   "
263876|NCT00094549|"~     The goals of this study are:~      A. To determine whether olanzapine can help patients with bipolar disorder who currently have~     mild to moderate mania.~      B. To assess the safety of olanzapine and any side effects that might be associated with it,~     as well as the quality of life and functioning of patients treated with olanzapine.~      C. To assess how olanzapine compares to divalproex.~   "
263877|NCT00094536|"~     The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used~     to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive~     menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be~     performed in a physicians office with minimal sedation.~      Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of~     a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6~     minutes with the Cryoprobe repositioned in the contralateral cornu.~      Since completion of the early studies, many physicians have experimented with varying freeze~     patterns using longer freeze durations and/or additional freezes at the fundus and the lower~     uterine segment. The results, as reported in the literature, indicate that these extended~     freeze patterns produce significantly better results than the original regimen.~   "
263878|NCT00094523|"~     This study was designed to evaluate and compare safety, tolerability of subjects who~     successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir.~     This is a 48-week study, where subjects who were assigned to be in their original PI-group~     have the option of switching to fosamprenavir on week 24. Prior to being assigned their~     treatment group, subjects had to be suppressed for at least three months. All subjects also~     take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.~   "
263879|NCT00094510|"~     This study will use magnetic resonance spectroscopy (MRS) and the drug gabapentin to examine~     the role of the brain chemical gamma-amino-butyric acid (GABA) in regulating emotions in~     healthy people. Gabapentin, which is used to treat epilepsy, increases GABA concentrations in~     the brain. MRS, similar to magnetic resonance imaging (MRI), is a diagnostic test that uses a~     magnetic field and radio waves to produce images of the brain.~      Non-smoking, healthy normal volunteers between 18 and 60 years of age may be eligible for~     this study. Candidates are screened with a medical history and physical examination,~     psychiatric evaluation, blood and urine tests, and an electrocardiogram (EKG).~      At three separate clinic visits, participants are given either gabapentin or a placebo (an~     inactive look-alike capsule). They take placebo at one visit, 600 mg of gabapentin at another~     visit, and 1200 mg of gabapentin at another visit. One hour after taking the capsules, the~     amount of GABA in the brain is measured by MRS. For this procedure, the subject lies on a~     table that moves into the MRI scanner (a narrow cylinder), wearing earplugs to muffle loud~     knocking and thumping sounds that occur during the scanning process. The procedure lasts~     about 45 to 60 minutes, during which the patient is asked to lie still for up to a few~     minutes at a time.~   "
263880|NCT00094497|"~     The purpose of this study is to determine whether treatment with etoposide, doxorubicin,~     cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane~     (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable~     to complete surgical resection.~   "
263881|NCT00094484|"~     The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with~     placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).~   "
263896|NCT00094276|"~     This study will evaluate two interventions that are designed to reduce asthma morbidity and~     improve asthma care of children in Head Start in urban Baltimore.~   "
263897|NCT00094263|"~     To use existing longitudinal data from the Chicago Heart Association and Western Electric~     Company studies to examine adiposity in relation to heart failure, multimorbidity and to~     examine heart rate in relation to incident diabetes.~   "
263898|NCT00094250|"~     This study is enrolling patients with congestive heart failure (CHF). The goal of the study~     is to see if one of two carefully monitored exercise programs can improve the ability of~     these patients to function and get about their activities.~   "
263882|NCT00094458|"~     The purpose of this study is to assess the safety and effectiveness of three different~     treatments for patients with Crohns disease who have not responded to previous treatment with~     a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients~     will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an~     immunosuppressant or drug used to suppress the immune system) or a combination of both for up~     to 34 weeks. This research study will involve approximately 500 patients. The main study~     involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks~     (approximately 5 months) is optional for patients who successfully complete the main study. A~     country-specific study extension of open label infliximab treatment for an additional 1 year~     is optional for patients who successfully complete the main study extension.~   "
263883|NCT00094445|"~     The goal of this clinical research study is to learn if treatment with curcumin can help~     shrink or slow the growth of pancreatic cancers. The effect of curcumin on the way pancreatic~     cancer cells function and the safety of treatment with curcumin will also be studied.~   "
263884|NCT00094432|"~     The purpose of this study is to evaluate several doses of aripiprazole in patients with~     bipolar depression.~   "
263885|NCT00094419|"~     The purpose of this study is to identify the types of and frequency of use of complementary~     and alternative medicine (CAM) strategies among low-income Caucasian and African American~     adults with persistent asthma. The overall goal is to collect data that will increase~     understanding of health beliefs and behaviors in people with low-income backgrounds so that~     studies can be created that may help modify and improve patients' symptoms of asthma.~   "
263886|NCT00094406|"~     This study will examine in healthy volunteers how breathing carbon monoxide (CO) affects lung~     inflammation. Severe lung inflammation sometimes develops in patients with pneumonia or~     patients who develop serious blood stream infections. Studies in the laboratory and in~     animals show that CO can decrease lung inflammation.~      Healthy volunteers between 18 and 40 years of age who do not smoke, are not taking any~     medications, do not have asthma, are not allergic to sulfa- and penicillin-based drugs, and~     are not pregnant may be eligible for this study. Candidates are screened with a medical~     history and physical examination, blood and urine tests, electrocardiogram (EKG), and chest~     x-ray. Subjects are enrolled in either a pilot study or the main study.~      Participants undergo bronchoscopy and bronchoalveolar lavage to study the effects of~     endotoxin (a component of bacteria that causes inflammation similar to that in patients with~     lung infections) on lung function. Before the procedure, a small plastic tube (catheter) is~     placed in a vein to collect blood samples and another is placed in an artery to check blood~     pressure. For the bronchoscopy, the mouth and nasal airways are numbed with lidocaine, and a~     bronchoscope (thin flexible tube) is passed through the nose into the airways of the lung. A~     small amount of salt water is squirted through the bronchoscope into one lung and then salt~     water containing endotoxin is squirted into the other lung.~      Following the bronchoscopy, subjects are treated with either CO or room air (placebo) for 6~     hours. (Subjects in the pilot study receive treatment for only 3 hours). The gas is delivered~     through a cushioned mask placed over the nose and mouth. The amount of exhaled CO is measured~     before, during, and after inhalation of the gas. For this measurement, subjects take a deep~     breath to fill up their lungs and slowly exhale into a mouthpiece connected to a measuring~     device until they feel their lungs are empty.~      After the CO treatment, a second bronchoscopy is done to examine how the lung responded to~     the CO or room air. This is studied in two ways. To sample the air, a large needle is used to~     withdraw air through the bronchoscope over about 3 seconds. Then the areas of the lung that~     were squirted with salt water alone and with endotoxin and salt water and are rinsed (lavage)~     and cells and secretions are collected.~   "
263887|NCT00094393|"~     This study will examine children with Hutchinson-Gilford Progeria syndrome, a genetic disease~     that causes many changes to the body over time, including heart disease, bone changes, hair~     loss, and joint and skin changes. Often called a premature aging disease, progeria does not~     mimic aging completely. This study will examine which body systems are affected in progeria~     and how each system is affected over time in order to try to develop new treatments.~      Patients with progeria who are between 6 months and 70 years of age and who are able to~     travel to the NIH in Bethesda, Md., may be eligible for this 5- to 10-year study.~      Participants come to the NIH Clinical Center for evaluation every 2 years. Each 4-5 day visit~     includes the following tests and procedures:~        -  Medical history and physical examination~        -  Blood tests to analyze cardiovascular risk factors, blood counts, blood chemistries, and~          for research~        -  Urine tests for sugar and proteins~        -  Photographs to study growth problems~        -  X-ray studies to determine bone density and body composition, such as body fat and~          muscle~        -  Electrocardiogram (EKG) and echocardiogram (heart ultrasound) to study the heart and~          blood vessels~        -  Lung function tests to measure energy consumption and lung capacity~        -  Skin biopsy (surgical removal of a small skin sample) to examine cellular changes~        -  Hearing tests~        -  Eye examination to evaluate eyesight, eye pressure and structures of the eye~        -  Physical therapy evaluation with stretching and exercises to measure how the joints bend~          and straighten~        -  Dental examination, including X-rays~        -  Meeting with a nutritionist who will track the patient's food intake and take body~          measurements~        -  Magnetic resonance imaging (MRI) for patients who are old enough to undergo the~          procedure without sedation. This test uses a magnetic field and radio waves to examine~          body organs. For this test, the patient must lie still in the scanner, a narrow~          cylindrical tube.~      Patients are provided the results of their medical tests. Information about the patient is~     submitted to the PRF Cell and Tissue Bank in Peabody, Massachusetts.~   "
263888|NCT00094380|"~     The purpose of this study is to examine the safety of a single dose of RG2077 in patients~     with systemic lupus erythematosus (SLE) who are currently receiving cyclophosphamide. This~     study will also determine if RG2077 is effective in decreasing disease activity in these~     patients.~      Study hypothesis: CTLA4-Ig mediates a T cell costimulatory blockade that effectively induces~     an antigen-specific nonresponsiveness in T cells.~   "
263889|NCT00094367|"~     This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of~     lamivudine once-daily as a single tablet were just as likely to have adverse events compared~     to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate~     tablets twice-daily.~   "
263890|NCT00094354|"~     The purpose of this study was to examine the needs, concerns, stigmas, and social networks of~     HIV infected former plasma donors (FPDs) and their relatives in Fuyang, Anhui Province,~     China. Interviews and focus groups were used to collect data in preparation for a future,~     larger behavioral study for HIV infected individuals in China.~   "
263891|NCT00094341|"~     The purpose of this study is to determine the preference of RA patients for the new Enbrel®~     (etanercept) pre-filled syringe in patients who are already taking Enbrel®.~   "
263892|NCT00094328|"~     The primary objective of this study is to investigate whether bicalutamide given in~     combination with anastrozole once daily for 12 months is effective in treating testotoxicosis~     in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in~     height, and development of muscles and sexual organs .~   "
263893|NCT00094315|"~     To study of classical conditioning mechanisms associated with arousal, craving and cocaine~     use.~   "
263894|NCT00094302|"~     The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy~     in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure~     hospitalization in patients who have heart failure with preserved systolic function.~   "
263895|NCT00094289|"~     The purpose of this study is to assess potential interactions between intravenous cocaine and~     ethanol and oral disulfiram.~   "
263903|NCT00094172|"~     Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop~     problems related to the central nervous system, which controls the nerves in the body. Some~     of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease~     of the nervous system. The purpose of this study is to determine if the drug atorvastatin is~     helpful to CIS patients.~      Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a~     state of immunological tolerance.~   "
263904|NCT00094159|"~     The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3~     weeks is safe.~   "
263905|NCT00094146|"~     This study is in patients with at least moderate obesity (Body Mass Index [BMI] > 30 kg/m2 or~     approximately 30 or more pounds overweight) and who also produce too much insulin (insulin~     stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to~     help with weight loss in people who find it hard to lose weight on their own because they~     produce too much insulin.~      The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that~     safely helps overweight people lose weight. The study will also compare weight loss in obese~     patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.~   "
263906|NCT00094133|"~     RATIONALE: Hypnosis may be effective in decreasing hot flashes in breast cancer survivors.~      PURPOSE: This randomized clinical trial is studying how well hypnosis works in treating hot~     flashes in breast cancer survivors.~   "
263907|NCT00094120|"~     Age-Related Macular Degeneration (AMD) is a degenerative disease of the retina that causes a~     progressive loss of central vision. AMD is the leading cause of legal blindness among adults~     age 50 or older in the Western world. AMD presents in two different types - dry and the~     more severe wet form. Wet AMD is caused by the growth of abnormal blood vessels in the~     macula.~      Squalamine lactate is an investigational drug that may prevent the growth of these abnormal~     blood vessels. This study will test the safety and efficacy of Squalamine when administered~     with verteporfin therapy in patients with wet AMD.~   "
263908|NCT00094107|"~     This is a Phase 2 study being conducted at multiple centers in the United States and France.~     Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are~     eligible to participate. Patients must have disease that has been treated with no more than 1~     prior treatment for metastatic disease (prior adjuvant treatment for localized disease does~     not count as prior treatment for metastatic disease). The purpose of the study is to test~     whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic~     melanoma as shown by the number of patients in the study who experience significant and~     durable tumor shrinkage.~   "
263909|NCT00094094|"~     This is a Phase 2 study being conducted at multiple centers in the United States and Germany.~     Patients having non-small cell lung cancer that has spread to other parts of the body (i.e.,~     metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are~     eligible to participate. Patients must have disease that has been treated with at least 1~     prior treatment for metastatic disease (prior adjuvant treatment for localized disease does~     not count as prior treatment for metastatic disease). The purpose of the study is to test~     whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small~     cell lung cancer as shown by the number of patients in the study who experience significant~     and durable tumor shrinkage~   "
263910|NCT00094081|"~     The trial will compare the efficacy and safety of concomitant chemoradiation with~     tirapazamine, cisplatin and radiation versus cisplatin and radiation.~   "
263911|NCT00091468|"~     The purpose of this 12-month study is to determine whether nicotine, administered in the form~     of nicotine patches, can improve symptoms of memory loss in some people experiencing mild~     memory problems (referred to in this study as mild cognitive impairment or MCI).~   "
263912|NCT00081627|"~     The objectives of this trial are to determine if CoFactor in combination with 5-FU are~     effective in the treatment of metastatic colorectal cancer and to determine the side effects~     observed with the administration of CoFactor and 5-FU.~   "
263913|NCT00094068|"~     This study will determine whether sildenafil citrate, commonly known as Viagra, can cause~     increased blood flow to the brain in a wide range of multiple sclerosis (MS) patients,~     including women. Although people with MS can have reduced blood flow in the brain as part of~     the disease process, it has been observed that men with MS may have increased blood flow to~     the brain while taking sildenafil citrate. This study will measure brain blood flow or blood~     volume in men and women with MS before and after taking Viagra and compare the results to~     those in healthy volunteers in an effort to better understand the disease.~      Healthy volunteers 18 years of age and older and patients with MS between 18 and 55 years of~     age may be eligible for this study. Volunteers are screened with a medical history and~     physical examination, and patients with MS are evaluated with a complete neurological~     examination and screening for heart disease, including history of chest pain, heart attack,~     and use of nitrates.~      Participants undergo magnetic resonance imaging (MRI) before and after taking Viagra. During~     the scanning, subjects lie still on a table that can slide in and out of the cylindrical~     metal scanner. Scanning time varies from 20 minutes to 3 hours, with most scans lasting~     between 45 and 90 minutes. First, a scan is obtained of the carotid arteries (major arteries~     in the neck supplying blood to the brain) to determine if the arteries are narrowed, and then~     baseline MRI scans and measures of brain blood flow are obtained. The subject then comes out~     of the scanner and takes a Viagra pill. After 1 hour, the subject returns to the scanner and~     more scans are obtained to determine changes in brain blood flow and blood volume following~     Viagra.~      A catheter (thin plastic tube) is placed in the subject's arm before he or she enters the~     magnet for the second time for injection of a contrast agent called gadolinium DTPA, which~     allows brain structures to be distinguished more clearly.~   "
263914|NCT00094055|"~     This is a Phase 2 study being conducted at multiple centers in the United States. Patients~     having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are~     eligible to participate. Patients must have disease that was not controlled by previous~     treatment with radioactive iodine (131I) or not be good candidates for such treatment. The~     purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective~     treatment for metastatic thyroid cancer as shown by the number of patients in the study who~     experience significant and durable tumor shrinkage.~   "
263915|NCT00094042|"~     This project seeks to understand how changes in the health of an individual affects the~     economic and social prosperity of the individual, family and community. The study involves~     providing iron supplements to a sample of participants in Central Java Indonesia and~     following those respondents for three years. They are compared with a control group who do~     not receive the supplement.~   "
264006|NCT00092755|"~     This study was conducted to assess the safety and tolerability of an investigational drug and~     to evaluate its effectiveness in the treatment of osteoarthritis of the hip or knee in both~     men and women.~   "
264007|NCT00092742|"~     The purpose of this study is to evaluate the long-term safety of an investigational drug~     versus an approved drug for the relief of pain in patients with rheumatoid arthritis.~   "
263916|NCT00094029|"~     The purpose of this study is to permit access to SU011248 for treatment use by patients with~     GIST given the following conditions: a) patients undergo screening, but are not eligible for~     participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which~     standard treatments have not been able to control with acceptable toxicity AND c) patients~     have the potential to derive clinical benefit from treatment with SU011248.~   "
263917|NCT00094016|"~     The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and~     QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in~     1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily~     asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal~     awakening and utilization of rescue medication per day also will be evaluated. In addition,~     an exploratory evaluation will assess the comparability of the two devices (i.e.,~     QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.~   "
263918|NCT00094003|"~     This study is to investigate the safety of NS-9 and to see how well it is tolerated in~     patients with cancer that has metastasized (spread) to the liver from another primary tumor.~     NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells.~     This study is also set up to determine the best dose to use.~   "
263919|NCT00093990|"~     The purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70~     or more with acute myeloid leukemia. Tipifarnib belongs to a class of drugs called Farnesyl~     Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.~   "
263920|NCT00093977|"~     The purpose of this study is to determine whether darbepoetin alfa manufactured by the~     current roller bottle technology and darbepoetin alfa manufactured by a serum free process~     have a comparable safety profile.~   "
263921|NCT00093964|"~     This study will investigate clinical activity, safety, and tolerability of the~     anti-angiogenic compound cilengitide (EMD 121974) in the treatment of first recurrence of~     glioblastoma multiforme (GBM).~   "
263922|NCT00093951|"~     The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and~     cognition in patients with mild to moderate Alzheimer's disease.~   "
263923|NCT00093938|"~     The purpose of this study is to determine the amount of cranberry juice that is most~     effective in preventing a condition in pregnant women that often leads to urinary tract~     infections (UTIs).~   "
263924|NCT00093925|"~     The purpose of this study is to establish the safety of clevidipine in the treatment of~     postoperative hypertension. Approximately 250-500 patients with postoperative hypertension~     after undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass~     (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve~     replacement/repair procedures were anticipated to be randomly assigned to one of two~     treatment groups: clevidipine or nicardipine.~   "
263925|NCT00093912|"~     The purpose of this study is to establish the safety of clevidipine in the treatment of~     perioperative hypertension. Approximately 250-500 patients with perioperative hypertension~     undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or~     minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve~     replacement/repair procedures were anticipated to be randomly assigned to one of two~     treatment groups: clevidipine or sodium nitroprusside.~   "
263926|NCT00093899|"~     The purpose of this study is to assess the cholesterol lowering effects of an investigational~     drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).~   "
263927|NCT00093886|"~     The purpose of this study is to establish the safety of clevidipine in the treatment of~     perioperative hypertension. Approximately 500-900 patients with perioperative hypertension~     undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or~     minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve~     replacement/repair procedures were anticipated to be randomly assigned to one of two~     treatment groups: clevidipine or nitroglycerin.~   "
263928|NCT00093873|"~     This study will determine the safety and pharmacokinetics of AMG 706 in subjects with~     advanced solid tumors.~   "
263929|NCT00093847|"~     This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant~     drug treatment in reducing depressive symptoms in depressed people who have not responded to~     antidepressants alone.~   "
263930|NCT00093834|"~     RATIONALE: Vaccines made from a person's tumor cells may make the body build an immune~     response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and~     doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Combining vaccine therapy with cyclophosphamide and doxorubicin may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide~     and doxorubicin when given with vaccine therapy in treating women with stage IV breast~     cancer.~   "
263931|NCT00093821|"~     This phase I trial is studying the side effects and best dose of tanespimycin in treating~     young patients with recurrent or refractory leukemia or selected solid tumors. Drugs used in~     chemotherapy, such as tanespimycin, work in different ways to stop cancer cells from dividing~     so they stop growing or die.~   "
263932|NCT00093808|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal~     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor~     killing substances to them without harming normal cells. Giving capecitabine and vinorelbine~     together with trastuzumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving capecitabine and vinorelbine~     together with trastuzumab works in treating patients who have metastatic breast cancer.~   "
263933|NCT00093795|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin , cyclophosphamide,~     paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they~     stop growing or die. Giving combination chemotherapy after surgery may kill any remaining~     tumor cells.~      PURPOSE: This randomized phase III trial is studying three different combination chemotherapy~     regimens and comparing how well they work in treating women who have undergone surgery for~     node-positive breast cancer.~   "
263934|NCT00093782|"~     This phase II trial is studying how well CCI-779 works in treating patients with progressive~     metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in~     different ways to stop tumor cells from dividing so they stop growing or die.~   "
263935|NCT00093769|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary~     for their growth. Monoclonal antibodies such as rituximab can locate cancer cells and either~     kill them or deliver tumor-killing substances to them without harming normal cells. Giving~     bortezomib together with rituximab may kill more cancer cells.~      PURPOSE: This randomized phase II trial is studying how well giving bortezomib together with~     rituximab works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.~   "
263936|NCT00093756|"~     This phase I/II trial (phase I closed to accrual as of 09/29/2009) is studying the side~     effects and best dose of bortezomib, paclitaxel, and carboplatin when given with radiation~     therapy and to see how well they work in treating patients with stage IIIA or stage IIIB~     non-small cell lung cancer that cannot be removed by surgery. Bortezomib may stop the growth~     of tumor cells by blocking the enzymes necessary for their growth. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells~     from dividing so they stop growing or die. Bortezomib may increase the effectiveness of~     paclitaxel and carboplatin by making tumor cells more sensitive to the drugs. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Giving bortezomib, paclitaxel, and~     carboplatin together with radiation therapy may kill more tumor cells.~   "
263937|NCT00093743|"~     Based on success in other diseases, the Fred Hutchinson Cancer Research Center (FHCRC) has~     developed a transplant procedure for Fanconi anemia (FA), which does not completely destroy~     the patient's remaining bone marrow. It should also be less harmful (toxic). Researchers wish~     to test whether this approach can overcome the graft failure often seen when bone marrow or~     peripheral blood stem cells from an unrelated donor are used. Researchers also will look at~     whether the procedure is less toxic than a conventional bone marrow transplant (BMT).~   "
263938|NCT00093730|"~     RATIONALE: BMS-599626 may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of BMS-599626 in~     treating patients with metastatic solid tumors.~   "
263939|NCT00093704|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary~     for their growth. The Epstein Barr virus can cause cancer and lymphoproliferative disorders.~     Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Giving ganciclovir~     together with bortezomib may kill more Epstein Barr virus-infected cancer cells.~      PURPOSE: This clinical trial is studying how well giving bortezomib together with ganciclovir~     works in treating patients with relapsed or refractory Epstein Barr virus-positive lymphoma.~   "
263940|NCT00093678|"~     RATIONALE: Celecoxib may help relieve moderate or severe pain associated with cancer. It may~     also decrease weight loss and improve muscle strength in cancer patients.~      PURPOSE: This randomized clinical trial is studying celecoxib to see how well it works in~     managing pain, weight loss, and weakness in patients with advanced cancer.~   "
263941|NCT00093665|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together~     with radiation therapy works in treating patients with stage II, stage III, or stage IV~     nasopharyngeal cancer.~   "
263942|NCT00093652|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor~     cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy~     x-rays to damage tumor cells. Combining oxaliplatin and gefitinib with radiation therapy may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin when~     given together with gefitinib and radiation therapy and to see how well they work in treating~     patients with locally advanced or metastatic esophageal cancer.~   "
263943|NCT00093639|"~     RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop~     cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth~     of cancer cells by blocking the enzymes necessary for their growth. Combining everolimus with~     imatinib mesylate may be effective in killing cancer cells that have become resistant to~     imatinib mesylate.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when~     given together with imatinib mesylate and to see how well they work in treating patients with~     chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission~     after previous imatinib mesylate.~   "
263944|NCT00093626|"~     Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by~     blocking the enzymes necessary for their growth. This phase II trial is studying how well~     sorafenib works in treating patients with persistent or recurrent ovarian epithelial or~     peritoneal cancer.~   "
263945|NCT00093613|"~     This phase I trial is studying the side effects and best dose of sorafenib in treating~     patients with recurrent or progressive malignant glioma. Sorafenib may stop the growth of~     tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for~     their growth.~   "
263946|NCT00093600|"~     RATIONALE: PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for~     their growth. It may also increase the effectiveness of daunorubicin and cytarabine by making~     cancer cells more sensitive to the drugs. Drugs used in chemotherapy, such as daunorubicin~     and cytarabine, work in different ways to stop cancer cells from dividing so they stop~     growing or die. Combining PKC412 with chemotherapy may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best way to give PKC412 when~     given either after or together with daunorubicin and cytarabine in treating patients with~     newly diagnosed acute myeloid leukemia.~   "
263960|NCT00093366|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to~     stop cancer cells from dividing so they stop growing or die. Biological therapies such as~     etanercept may interfere with the growth of the cancer cells. Combining chemotherapy with~     biological therapy may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving arsenic trioxide~     together with etanercept and to see how well it works in treating patients with~     myelodysplastic syndromes.~   "
264008|NCT00092729|"~     The purpose of this study is to evaluate the pain relieving effect and safety of an~     investigational drug in women with moderate to severe primary dysmenorrhea (painful~     menstruation).~   "
263947|NCT00093587|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow~     transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It~     also helps stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving antithymocyte globulin before transplant and cyclosporine after transplant may stop~     this from happening.~      PURPOSE: This randomized clinical trial is studying how well giving antithymocyte globulin~     together with cyclosporine works in preventing graft-versus-host disease in patients who are~     undergoing chemotherapy with or without radiation therapy followed by donor stem cell~     transplant for acute lymphoblastic leukemia or acute myeloid leukemia.~   "
263948|NCT00093561|"~     RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the~     development or recurrence of cancer. The dietary supplement lycopene may prevent the~     development of prostate cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in~     preventing prostate cancer in healthy participants.~   "
263949|NCT00093548|"~     RATIONALE: Vaccines made from DNA and a gene-modified virus may make the body build an immune~     response to kill tumor cells. Giving booster vaccinations may make a stronger immune response~     and prevent or delay the recurrence of liver cancer.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy~     and to see how well it works in treating patients with stage II, stage IIIA, stage IIIB, or~     stage IVA liver cancer.~   "
263950|NCT00093522|"~     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body~     build an immune response to kill tumor cells. Drugs used in chemotherapy, such as~     fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Combining vaccine therapy with fludarabine may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying vaccine therapy and fludarabine to see~     how well they work compared to vaccine therapy alone in treating patients with stage IV~     kidney cancer.~   "
263951|NCT00093509|"~     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above~     body temperature. Using MRI to measure heat may help to determine the effectiveness of~     hyperthermia therapy. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs~     used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Combining hyperthermia with radiation~     therapy and chemotherapy before surgery may kill more tumor cells and shrink the tumor so~     that it can be removed.~      PURPOSE: This phase I/II trial is studying the side effects of hyperthermia when given~     together with radiation therapy and optional chemotherapy and to see how well they work in~     treating patients who are undergoing surgery for soft tissue sarcoma of the limbs.~   "
263952|NCT00093496|"~     Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in~     treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity~     cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work~     in different ways to stop tumor cells from dividing so they stop growing or die.~   "
263953|NCT00093483|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, cytarabine, and idarubicin,~     work in different ways to stop cancer cells from dividing so they stop growing or die.~     Combining more than one drug may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide~     when given together with cytarabine and idarubicin in treating patients with acute myeloid~     leukemia.~   "
263954|NCT00093470|"~     This randomized phase III trial studies tipifarnib in treating patients with acute myeloid~     leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the~     enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective~     than observation alone in preventing the recurrence of AML.~   "
263955|NCT00093457|"~     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth.~      PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients~     who have metastatic or recurrent prostate cancer that has not responded to previous hormone~     therapy.~   "
263956|NCT00093444|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways~     to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses~     high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with~     liposomal doxorubicin may increase the effectiveness of the drug and kill more tumor cells.~      PURPOSE: This phase I trial is studying the best dose of liposomal doxorubicin when given~     with radiofrequency ablation in treating patients with primary or metastatic liver tumors.~   "
263957|NCT00093418|"~     This randomized phase II trial is studying 4 different tipifarnib regimens to compare how~     well they work in treating older patients with acute myeloid leukemia. Tipifarnib may stop~     the growth of cancer cells by blocking the enzymes necessary for their growth~   "
263958|NCT00093405|"~     RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work~     in different ways to stop tumor cells from dividing so they stop growing or die.~     17-N-allylamino-17-demethoxygeldanamycin may also stop the growth of tumor cells by blocking~     the enzymes necessary for their growth.~      PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin~     works in treating patients with metastatic kidney cancer.~   "
263959|NCT00093379|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine~     may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy~     uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor~     cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with~     radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin~     together with radiation therapy works in treating patients with stage II or stage III anal~     cancer.~   "
264002|NCT00092820|"~     This is an extension study for patients having unusually high absorption of non-cholesterol~     sterols, resulting in heart-related diseases. This study will evaluate the long term safety~     and the ability to lower cholesterol levels with an investigational drug.~   "
263961|NCT00093353|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help~     irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be~     effective in preventing diarrhea that is caused by treatment with irinotecan.~      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when~     given together with temozolomide and cefixime in treating young patients with recurrent or~     resistant neuroblastoma.~   "
263962|NCT00093327|"~     The purpose of this study is to determine whether acupuncture is effective in reducing the~     symptoms of irritable bowel syndrome (IBS).~   "
263963|NCT00093314|"~     The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a~     treatment for Chronic Lymphocytic Leukemia.~   "
263964|NCT00093860|"~     This study will examine the effectiveness of the drug propranolol in preventing fainting in~     patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system~     and chemical responses in which the blood vessels in skeletal muscles do not remain~     constricted appropriately during standing for a long time. This can lower blood pressure and~     cause fainting. Propranolol (Inderal® (Registered Trademark)) is a Food and Drug~     Administration-approved drug that belongs to a class of drugs called beta-blockers. These~     drugs slow the heart rate and maintain blood pressure in certain situations.~      Children between 10 and 17 years of age with frequent fainting or near-fainting due to SAI~     may be eligible for this study. Children must experience severe dizzy episodes at least once~     every 2 months or fainting episodes at least once every 4 months. The condition must be~     severe enough to affect the child's quality of life or to have forced the child to alter his~     or her life routines to accommodate to the illness. Screening includes a tilt table test,~     described below, to determine if the child has a particular chemical pattern in the blood.~      Children enrolled in the study take propranolol pills in increasing doses during the first~     week of the study to determine the proper dose for the individual. Then, the drug is stopped~     until the experimental phase of the study begins. In this phase, children are randomly~     assigned to take either propranolol or placebo (a look-alike pill with no active ingredient)~     for a maximum of 3 days. On the fourth day, the child undergoes a tilt table test to~     determine whether the treatment affects his or her ability to tolerate tilt. For this test,~     the child lies on a padded table with a motorized tilt mechanism that can move the child from~     a flat position to an upright position in about 10 seconds. The child remains upright for up~     to 40 minutes while the following measurements are taken:~        -  Blood sampling: Blood is drawn through a catheter (thin plastic tube) placed in an arm~          vein. This allows repeated sampling without repeated needle sticks. Samples are~          collected before starting the tilt test, about every 4 minutes during the test,~          immediately when a drop in blood pressure is detected or symptoms develop, and after 10~          minutes of recovery lying flat. A maximum of 12 samples are collected for each tilt~          test.~        -  Physiologic measurements: Blood pressure, heart rate, and electrocardiogram (EKG) are~          measured continuously during the tilt test session, and blood flows and skin electrical~          conduction are measured intermittently. Blood flow is measured using sensors applied to~          the skin and a blood pressure cuff around the limb. For skin blood flow measurements, a~          laser beam scans the skin surface. The skin electrical conduction test measures how well~          the skin conducts electricity. This is measured through sensors placed on the tips of~          two fingers. Respiration and breathing rate are monitored by an elastic cloth band~          around the chest.~        -  Self-report questionnaires: Patients or their parents complete a questionnaire about the~          child's symptoms before and during treatment.~      The effects of the test drug are allowed to wear off for up to 1 week, after which the entire~     tilt test procedure is repeated. Patients who were given propranolol for the first test~     session take placebo for the repeat session, and those who were given placebo take~     propranolol.~   "
263965|NCT00093301|"~     The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine~     in patients with unstable hemodynamics (shock).~   "
263966|NCT00093288|"~     This is a placebo-controlled study evaluating the effectiveness of medication in elderly~     subjects with Major Depressive Disorder (MDD).~   "
263967|NCT00093275|"~     The purpose of this study is to determine whether HP184 is effective in the treatment of~     chronic spinal cord injury (CSCI).~   "
263968|NCT00093262|"~     The purpose of this study is to establish the efficacy of of clevidipine versus placebo in~     treating postoperative hypertension. Approximately 100 patients with postoperative~     hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery~     bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or~     valve replacement/repair procedures were anticipated to be randomly assigned to one of two~     treatment groups: clevidipine or placebo.~   "
263969|NCT00093249|"~     The purpose of this study is to determine the efficacy of clevidipine injection versus~     placebo in treating preoperative hypertension.~   "
263970|NCT00093236|"~     The purpose of this study is to determine the effect of gum infection on parameters of~     cardio-vascular disease.~   "
263971|NCT00093223|"~     This trial will treat patients with a new chemotherapeutic medicine who have undergone a~     successful and uncomplicated de novo stent placement in up to two native coronary arteries.~     The purpose of the trial is to determine the appropriate dose of the new medicine for future~     trials and to evaluate the incidence of treatment-emergent adverse events and serious adverse~     events.~   "
263972|NCT00093210|"~     The primary objective of this clinical research study is to establish the bioequivalence of 2~     treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.~   "
263973|NCT00093197|"~     Restoring blood flow to coronary arteries as quickly as possible is the best way to reduce~     the damage to the muscle that occurs with a heart attack. However, up to 25-50% of patients~     who have angioplasty may have ongoing damage to the heart muscle when the blockage is opened~     and blood flow is restored. Complications which may result from this ongoing damage include a~     larger area of damaged muscle in the heart, enlargement of the heart, an increased risk of~     death, and an increased risk of heart failure. Some of the ongoing damage may involve~     increased levels of the protein kinase C (PKC) enzyme. KAI-9803 is a selective inhibitor of~     delta PKC. In this study, delta PKC is used with angioplasty and other standard procedures to~     restore blood flow after a heart attack. This study is designed to evaluate safety of~     different amounts of KAI-9803 when used in treating heart attack patients undergoing~     angioplasty. We will also try to evaluate whether KAI-9803 can reduce the amount of heart~     muscle damage and the complications that may occur in these patients.~   "
263974|NCT00093184|"~     The purpose of this study is to demonstrate the benefit of bivalirudin in combination with~     clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications~     associated with early invasive management of patients presenting with an ST Elevation~     Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of~     ischemic events when compared to published results of relevant trials.~   "
263975|NCT00093171|"~     The primary objective of this clinical research study is to assess the safety and efficacy of~     rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C~     ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor~     surgical procedures).~   "
263976|NCT00093158|"~     The purpose of this study is to show that, when compared with heparin (enoxaparin or~     unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the~     time of percutaneous coronary intervention [PCI]; Arm A):~        1. Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time of~          PCI; Arm B) provides non-inferior or superior overall clinical outcomes and~        2. Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important~          secondary objective for this comparison is to show that bivalirudin is not inferior for~          ischemic complications.~   "
263977|NCT00093145|"~     This trial will treat patients with advanced breast cancer with a new anti-cancer medicine~     used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel~     (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a~     weekly basis and may continue on therapy as long as their condition improves and drug~     toxicity is tolerated.~   "
263978|NCT00002543|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: : Phase I trial to study the effectiveness of gallium nitrate in young patients who~     have malignant brain tumors, neuroblastoma, rhabdomyosarcoma, non-Hodgkin's lymphoma, or~     refractory solid tumor.~   "
263979|NCT00002524|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with AIDS-related lymphoma.~   "
264003|NCT00092807|"~     This is an extension study for patients having unusually high absorption of non-cholesterol~     sterols, resulting in heart-related diseases. This study will evaluate the long term safety~     and the ability to lower cholesterol levels with an investigational drug.~   "
264004|NCT00092781|"~     The purpose of this study is to compare the safety and effectiveness of an investigational~     drug and an approved drug in the treatment of osteoarthritis of the knee and hip.~   "
263980|NCT00093132|"~     PURPOSE: This trial is designed to compare the combination of the investigational oral~     cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced~     Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment.~     Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.~      WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member~     of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically~     proven to be one of the most effective classes of anticancer therapies. Unlike the currently~     marketed platinum-based drugs, satraplatin can be given orally.~      RATIONALE: Intravenously administered platinum-based drugs are currently used in combination~     with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose~     of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum~     drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy~     treatment.~   "
263981|NCT00093119|"~     This trial will treat patients previously treated for advanced (metastatic) melanoma (skin~     cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered~     weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles~     of therapy will be given to determine the anti-tumor response of the new chemotherapy.~     Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows~     continuing benefit.~   "
263982|NCT00093093|"~     The purpose of this study is to determine the safety and effectiveness of viramidine to~     ribavirin in chronic hepatitis C patients who have never before received treatment.~   "
263983|NCT00093080|"~     The purpose of this study is to assess the efficacy of ridaforolimus when administered once~     daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.~   "
263984|NCT00093067|"~     The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic,~     to standard therapy in subjects who have infective endocarditis or bacteremia due to~     Staphylococcus aureus (S. aureus).~   "
263985|NCT00093054|"~     The purpose of this study is to determine whether daily consumption of cranberry juice~     lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This~     study will also determine whether drinking cranberry juice for 6 months selects for less~     virulent bacteria in the rectal, vaginal, and urethral areas.~   "
263986|NCT00093041|"~     The purpose of this trial is to determine the safety of zalutumumab as a treatment for head~     and neck cancer.~   "
263987|NCT00093028|"~     The purpose of this study is~        -  to find out the effects of treating patients with two new chemotherapy drugs (bortezomib~          and Revlimid™),~        -  to study how many patients' myeloma responds to treatment on this study, and how many~          patients survive after this treatment,~        -  to learn if a patient's genetic makeup before and after treatment can predict which~          patients will respond to bortezomib and Revlimid™, and to learn more about how the body~          responds (gene array studies).~   "
263988|NCT00091520|"~     The purpose of this study is to evaluate the efficacy and safety of Nesiritide administered~     as serial infusions to heart failure (HF) patients in the outpatient setting.~   "
263989|NCT00093015|"~     The purpose of this study is to assess the impact of treatment of anemia with darbepoetin~     alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular~     events, and (2) progression to end-stage renal disease or death, in subjects with chronic~     kidney disease and type 2 diabetes mellitus.~      Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD~   "
263990|NCT00093002|"~     The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast~     cancer treatment and assess the relationship between dose, exposure, degree of reduction in~     tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.~   "
263991|NCT00092989|"~     The purpose of this study is to evaluate improved results of treatment for patients entering~     an emergency department with asthma attacks when given an investigational IV administration~     of an approved drug (MK-0476, montelukast sodium) in addition to approved standard treatment.~   "
263992|NCT00092976|"~     The primary objective of this clinical research study is to evaluate the safety and efficacy~     of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the~     chromogenic substrate assay at the local laboratory.~   "
263993|NCT00092963|"~     The purpose of this study is to test the effectiveness of an approved drug in the early~     treatment of migraine while the pain is still mild.~   "
263994|NCT00092924|"~     The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with~     relapsed or refractory non-small cell lung cancer.~   "
263995|NCT00092911|"~     The main objective of this study is to compare the antidepressant efficacy and safety of~     DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.~   "
263996|NCT00092898|"~     This is a 6-month study with patients who have the rare disease, sitosterolemia which may~     result in heart-related diseases. These patients have unusually high absorption of~     non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether~     absorption of these non-cholesterols can be reduced in these patients.~   "
263997|NCT00092885|"~     The purpose of this study is to determine the effect of an approved medication on the~     symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous~     membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis~     and asthma.~   "
263998|NCT00092872|"~     This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational~     drug in obese patients after a very low calorie diet.~   "
263999|NCT00092859|"~     This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational~     drug in obese patients.~   "
264000|NCT00092846|"~     The purpose of this study is to evaluate the ability of patients with intermediate risk of~     heart disease to appropriately use a Self-Management System.~   "
264001|NCT00092833|"~     The purpose of this study is to provide an investigational drug to patients with a specific~     type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption~     of non-cholesterol sterols) in a treatment use setting.~   "
264005|NCT00092768|"~     The purpose of this study is to compare the safety and effectiveness of an investigational~     drug and an approved drug in the treatment of osteoarthritis of the knee and hip.~   "
264010|NCT00092703|"~     The purpose of this study is to compare the gastrointestinal tolerability of an~     investigational drug to an approved drug in the treatment of osteoarthritis during one year~     treatment period.~   "
264011|NCT00092690|"~     This study is to assess the safety and efficacy of an investigational drug as compared to an~     approved drug to reduce specific cholesterol levels.~   "
264012|NCT00092677|"~     The purpose of this study is to evaluate whether treatment with an investigational drug as~     compared to placebo will reduce the risk of major cardiovascular events in patients with~     aortic stenosis.~   "
264013|NCT00092664|"~     The purpose of this study is to evaluate the lipid lowering effects of an investigational~     drug in patients with hypercholesterolemia (high cholesterol).~   "
264014|NCT00092651|"~     The purpose of this study is to evaluate the lipid lowering effects of an investigational~     drug in patients with hypercholesterolemia (high cholesterol).~   "
264015|NCT00092586|"~     The purpose of this 6-week study is to compare the reduction in specific levels of~     cholesterol in patients with high cholesterol.~   "
264016|NCT00092573|"~     The purpose of this study is to assess the cholesterol lowering safety and effectiveness of~     two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high~     triglycerides).~   "
264017|NCT00092560|"~     The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of~     two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high~     triglycerides).~   "
264018|NCT00092547|"~     This study is to evaluate the safety, tolerability, and immune response of an investigational~     vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma~     Virus (HPV).~   "
264019|NCT00092534|"~     The primary purpose of the study is to determine if Gardasil (V501) an investigational~     vaccine with 4 components is able to prevent cervical cancer.~   "
264020|NCT00092521|"~     The primary purpose of the study is to determine if GARDASIL (V501) with four components is~     able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial~     Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.~   "
264021|NCT00092508|"~     This dose comparison study, taking place at over 200 sites worldwide, will compare the~     dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and~     efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.~   "
264022|NCT00092300|"~     The purpose of this study is to compare the safety and effectiveness of two approved drugs in~     the treatment of pain following dental surgery.~   "
264023|NCT00092950|"~     This 2-part study will examine how much exercise people usually do in the course of their~     daily lives and how two different types of exercise-stretching and walking-affect the amount~     of fat in the body and certain hormones in the blood. It will also examine whether exercise~     can be increased by physician counseling with and without the use of a pedometer, and if~     exercising changes levels of stress, anxiety, and depression.~      Breast cancer survivors and women at high risk for breast cancer who are between 18 and 75~     years of age and who exercise less than 3 times per week may be eligible for this study.~     Candidates are screened with a medical history and physical examination, and their endurance~     and flexibility are tested by stretching exercises and by a 6-minute walk or run.~      All participants complete study Part 1. Those who are eligible may also participate in Part~     2.~        -  Part 1: Subjects wear a pedometer (a small device that measures the number of steps~          taken) on their waistband during all waking hours for 1 week without changing their~          usual level of activity. Depending on their level of activity, subjects may be invited~          to participate in Part 2 of the study.~        -  Part 2: Subjects are placed in either a walking group or a stretching group for 12~          weeks. At the end of the 12-week period, those in the walking group are offered~          participation in the stretching group, and those in the stretching group are offered~          participation in the walking group.~      Walking group participants wear a pedometer every day for 12 weeks. They are asked to~     gradually increase the number of steps they take each day, to keep a record of their daily~     step count, and to report periodically to the study staff on their progress. For 1 week~     during the study, participants also wear a device called an accelerometer that is used to~     verify the accuracy of the pedometer step counts.~      Stretching group participants follow a program of stretching exercises for 12 weeks, with~     their progress monitored periodically by staff. During week 12, participants wear a pedometer~     and accelerometer.~      All Part 2 participants also have the following tests and procedures:~        -  Blood draw: collected at the beginning and end of the study to test for certain hormones~          and HDL cholesterol levels.~        -  Questionnaires: about stress, anxiety, and depression levels; these are completed at the~          beginning and end of the study, and a detailed questionnaire about diet is completed at~          home or during a clinic visit.~        -  Body composition measurement: A bioelectrical impedance test, which measures body fat,~          is done at the beginning and end of the study. For this test, the subject lies on an~          examining table and a small electrical current is passed through electrodes placed on~          one hand and one foot. Although a small electrical current is used, this test is not~          painful.~        -  Endurance and flexibility testing: At the end of the study, participants repeat the~          6-minute walk or run endurance test and the stretching flexibility test performed at~          screening.~   "
264024|NCT00092937|"~     This protocol is designed for a single specific patient. It uses busulfan as a conditioning~     agent in a second stem cell transplant procedure for a patient with chronic granulomatous~     disease (CGD), a disorder in which a certain type of white cells, called myeloid cells, do~     not function properly. This causes increased risk of serious bacterial and fungal infections~     that can lead to organ dysfunction, such as kidney disease, as well as formation of~     granulomas-non-cancerous masses that can cause obstructions in the esophagus, stomach, and~     intestines, and block urine flow from the kidneys and bladder.). The child in this study has~     previously undergone a stem cell transplant to treat CGD, and, as a result, he is now~     producing normal lymphocytes (another type of white cell). However, the myeloid cells from~     the donor did not engraft successfully, and the patient is still producing his own defective~     myeloid cells. In this study, the child will undergo a second stem cell transplant in~     combination with busulfan, a drug that targets myeloid cells, killing them to make way for~     healthy, donated myeloid cells.~      Treatment includes the following procedures:~        -  Medical evaluation to confirm that the patient is healthy enough to undergo the~          transplantation~        -  Treatment with busulfan, injected through the patient's central venous line~        -  Stem cell transplantation through the central venous line~        -  Blood tests on days 25, 56, and 91 after the transplant to assess how many cells are of~          donor origin~        -  Bone marrow aspiration on day 100, and then at 12, 24, and 36 months to assess how many~          cells are of donor origin~        -  Pulmonary function (breathing) test at 12 and 24 months~        -  Physical examination and blood tests, weekly or twice weekly for the first 2 to 3 months~          and at 4, 6, 12, 18, 24, 36, 48, and 60 months after transplant~        -  Treatment for graft-versus-host disease (GVHD), if this complication develops. GVHD is~          the attack of lymphocytes from the donor against the patient's own cells. This is good~          if it is against abnormal cells, but bad if serious damage occurs to the patient's vital~          organs. GVHD is treated with steroids and cyclosporine, and possibly other drugs if~          needed.~   "
264025|NCT00092638|"~     The purpose of this study is to investigate additional cholesterol lowering effects in~     patients with coronary heart disease by giving an investigational drug with a patient's~     current approved cholesterol lowering medication.~   "
264026|NCT00092625|"~     The purpose of this study is to investigate additional cholesterol lowering effects in~     patients with coronary heart disease by giving an investigational drug with a patient's~     current approved cholesterol lowering medication.~   "
264027|NCT00092612|"~     The purpose of this study is to investigate additional cholesterol lowering effects in~     patients with coronary heart disease by giving an investigational drug with a patient's~     current approved cholesterol lowering medication.~   "
264028|NCT00092599|"~     This study will evaluate patients who have coronary heart disease to determine if an~     investigational drug will further lower cholesterol when taken in combination with an~     approved cholesterol lowering medication.~   "
264029|NCT00092495|"~     The primary purpose of the study is to determine if an investigational vaccine Gardasil~     (V501) with 4 components will provide an immune response and will be well tolerated in~     pre-adolescents and adolescents.~   "
264030|NCT00092482|"~     The purpose of the study is to determine if an investigational vaccine with a single~     component develops an immune response that is similar to the equivalent investigational~     vaccine with four components to reduce cervical disease.~   "
264031|NCT00092469|"~     The purpose of this study is to evaluate the safety, tolerability, and immune response of an~     investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis,~     tetanus, hepatitis B, poliomyelitis, and Haemophilus influenza type b.~   "
264032|NCT00092456|"~     This study was designed to evaluate consistency in the antibody response to three~     manufactured lots of an investigational Rotavirus Vaccine.~   "
264033|NCT00092443|"~     This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and~     the efficacy to prevent Rotavirus Gastroenteritis.~   "
264034|NCT00092430|"~     The purpose of this study is to demonstrate that an investigational refrigerated vaccine with~     measles, mumps, rubella, and varicella is well tolerated and has similar immune response when~     compared to a frozen vaccine with measles, mumps, rubella, and varicella.~   "
264035|NCT00092417|"~     This study compared the safety and tolerability profile of a higher potency investigational~     vaccine to that of the investigational vaccine at a lower potency dose.~   "
264036|NCT00092404|"~     The purpose of this trial is to study the safety and immune response to measles, mumps, and~     rubella in children who were vaccinated with an investigational measles-mumps-rubella live~     vaccine made with artificially made human protein.~   "
264037|NCT00092391|"~     The purpose of this study is to determine the mumps virus strength at the end of shelf-life~     (expiration date) of an approved vaccine.~   "
264038|NCT00092378|"~     This purpose of this study is to compare the safety and effectiveness of two approved drugs~     in the treatment of pain following bunionectomy surgery.~   "
264039|NCT00092365|"~     The purpose of this study is to compare the safety and effectiveness of two approved drugs in~     the treatment of osteoarthritis of the knee.~   "
264040|NCT00092352|"~     The purpose of this study is to compare the safety and effectiveness of two approved drugs in~     the treatment of osteoarthritis of the knee.~   "
264041|NCT00092339|"~     The purpose of this study is to compare the safety and effectiveness of two approved drugs in~     the treatment of pain following dental surgery.~   "
264042|NCT00092326|"~     The purpose of this study is to compare the safety and effectiveness of two approved drugs in~     the treatment of pain following dental surgery.~   "
264043|NCT00092313|"~     The purpose of this study is to compare the safety and effectiveness of two approved drugs in~     the treatment of pain following dental surgery.~   "
264044|NCT00092287|"~     The aim of this study is to compare the efficacy and safety of lanreotide Autogel and~     Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce~     a similar clinical response in patients with carcinoid syndrome.~   "
264045|NCT00092274|"~     The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a~     treatment for Follicular Lymphoma (FL).~   "
264046|NCT00092001|"~     The purpose of this study is to test whether SU011248 has activity and is safe in patients~     with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing~     regimen and docetaxel.~   "
264047|NCT00091650|"~     The goals of this study are to determine: the safety of olanzapine and any side effects that~     might be associated with it, how olanzapine compares to placebo, whether olanzapine can help~     patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine~     should be given to patients.~   "
264048|NCT00092209|"~     The purpose of this study is to evaluate antihypertensive (lowering blood pressure)~     effectiveness of three combinations of approved study drugs compared to both study drugs~     being given alone.~   "
264049|NCT00092196|"~     The purpose of this study is to determine the efficacy and tolerability of an investigational~     drug for the prevention of chemotherapy-induced nausea and vomiting associated with~     moderately emetogenic chemotherapy.~   "
264050|NCT00092183|"~     This protocol will study an investigational drug treatment plan against standard therapy in~     the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast~     cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic~     chemotherapy.~   "
264051|NCT00092170|"~     The purpose of this study is to determine the effect of an approved medication for adults for~     an investigational use in pediatric patients 3 months to 17 years for the treatment of~     complicated intra-abdominal infections or acute pelvic infections.~   "
264052|NCT00092157|"~     The purpose of this study is to evaluate the safety and effectiveness of two approved drugs~     in lowering high cholesterol when taken together, compared to taking only one of the drugs.~   "
264053|NCT00092144|"~     The purpose of this study is to assess the efficacy and safety of an approved drug on asthma~     symptoms in patients with chronic asthma which is also active during the allergy season.~   "
264054|NCT00092131|"~     The purpose of this study is to determine the effect of an approved medication being studied~     in support of a new approach in the prevention of exercise-induced asthma (a worsening of~     asthma caused by exercise, also known as exercise-induced bronchospasm), in participants who~     have a history of worsening asthma after exercise.~   "
264055|NCT00092118|"~     The purpose of this study is to determine the effect of an approved medication on the~     symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose~     similar to that found in hay fever except that symptoms persist throughout the year), in~     patients who have a history of perennial allergic rhinitis.~   "
264056|NCT00092105|"~     The purpose of this study is to determine the protective effect of an approved medication on~     asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure~     to cats.~   "
264057|NCT00092092|"~     The purpose of this study is to determine the effect of montelukast, an approved medication,~     on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the~     lower leg length (LLL) growth rate for children treated with montelukast compared to placebo~     will be established.~   "
264058|NCT00092079|"~     The purpose of this study is to test the safety, tolerability, and effectiveness of an~     investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and~     deficiency during treatment of osteoporosis in men and postmenopausal women.~   "
264059|NCT00092066|"~     The purpose of this study is to test the safety, tolerability and effectiveness of an~     investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and~     deficiency during the treatment of osteoporosis in men and postmenopausal women.~   "
264060|NCT00092053|"~     The purpose of this study is to evaluate the efficacy and safety of an investigational drug~     in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in~     postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150~     mg, does not achieve persistence in reduction of bone resorption throughout the monthly~     dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked~     telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post~     dose compared to one week post dose, during the third month of treatment, in the participants~     taking ibandronate than in the participants taking placebo.~   "
264061|NCT00092040|"~     The purpose of this study and 12 month extension is to evaluate the effects of two~     investigational drugs on osteoporosis in postmenopausal women.~   "
264062|NCT00092027|"~     This study is to assess the safety and tolerability of MK0217 being evaluated to treat women~     with postmenopausal osteoporosis.~   "
264063|NCT00092014|"~     This study is to evaluate and compare the effects of Alendronate and Risedronate to treat~     women with postmenopausal osteoporosis. The primary hypothesis for this study is that in~     postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly~     will produce a mean percent increase from baseline in hip trochanter bone mineral density~     (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg~     once weekly.~   "
264064|NCT00091962|"~     The purpose of this study is to treat depression in patients who have undergone coronary~     artery bypass graft (CABG).~   "
264065|NCT00092235|"~     Background:~        -  Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune~          disorder that occurs following allogeneic hematopoietic stem cell transplantation~          (alloHSCT). It is characterized by immune dysregulation, immunodeficiency, impaired~          organ function, and decreased survival.~        -  Each year about 7000 patients receive allogeneic hematopoietic stem cell transplant~          (alloHSCT) in North America and about 50% of patients who are transplanted develop~          cGVHD.~        -  Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly~          variable fashion and requires complex and coordinated medical management by multiple~          medical specialties. There is an urgent need for progress in understanding and effective~          treatments for cGVHD as it is one of the most serious complications of cancer therapy~          and hematopoietic stem cell transplantation.~      Objectives:~        -  To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and~          natural history of cGVHD.~        -  To prospectively identify clinical and biological prognostic markers in patients with~          cGVHD.~        -  To develop clinically relevant cGVHD grading scales.~        -  To identify novel biological characteristics of cGVHD and to describe them in the~          context of clinical history and presentation.~        -  To identify potential clinical and biological markers of cGVHD activity.~        -  To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects.~      Eligibility:~      -Patients age 1-75 referred by the primary transplant physician for the evaluation of chronic~     graft-versus-host disease independent of underlying diagnosis.~      Design:~        -  Patient undergoes initial clinical and labotory multispecialty work-up at the NCI cGVHD~          clinic.~        -  Minimally invasive biopsies and rarely, deep tissue biopsy may be obtained to confirm~          the diagnosis and/or rule-out other pathologic process (in adults only).~        -  Long tem data collection for evaluation of long-term outcomes will be conducted every~          six months during the first three years of the study and then yearly.~   "
264066|NCT00092222|"~     This study will gain information about a rare disorder called KSHV-associated multicentric~     Castleman s disease (MCD). KSHV, a virus, causes several kinds of cancer, including some~     forms of MCD. KSHV stands for the Kaposi s sarcoma herpes virus, also called human herpes~     virus-8, or HHV-8. Researchers want to understand the biology of KSHV-MCD to identify how~     this disease causes illness and to find ways to treat it. There is no standard therapy~     effective for all cases of KSHV-MCD. The disease is often fatal, and about half the people~     who have it die within 2 years of diagnosis.~      Patients ages 12 and older may be eligible for this study. Participation entails more drawing~     of blood and having repeated tumor biopsies than if patients received treatment in a~     non-research setting. Researchers would like to learn more about the relationship of KSHV and~     Castleman s disease symptoms, and they want to obtain at least three biopsies in this study.~      There are some side effects of experimental therapy that patients may take for KSHV-MCD.~     Zidovudine, or Retrovir , is used at a high dose. It is given orally or through a vein, four~     times daily, for 7 days or longer. Zidovudine can cause nausea, vomiting, decreased bone~     marrow function, and decreased blood counts. Combined with valganciclovir, or Valcyte , it is~     likely to be more toxic to bone marrow. Valganciclovir can cause problems with bone marrow~     function, leading to low blood counts, sterility, and defects in a fetus. Combined with~     zidovudine, valganciclovir may cause more toxicity to the bone marrow. It is given twice~     daily for 7 days or longer. Bortezomib, or Velcade , is given for a few seconds by a rapid~     push through a needle into the vein. It is given twice weekly for four doses and then stopped~     for 1 week. Bortezomib can sometimes cause low blood pressure; it also can cause~     gastrointestinal problems and a low blood platelet count. Rituximab and liposomal doxorubicin~     are drugs given by a catheter into a vein. Interferon-alpha is given by injection into the~     skin. Those drugs are not experimental, but their use in Castleman s disease is experimental.~      Some patients may be treated with a combination of chemotherapy followed by interferon-alpha.~     Interferon-alpha is infected into the skin by a needle. The natural form of interferon is~     produced by the body and helps to control viral infections. KSHV decreases the effect of the~     body s interferon, and the researchers want to see if giving higher doses of interferon will~     help to control KSHV infection.~      A positron emission tomography (PET) scan, for research purposes only, may be done up to~     three times a year. A radioactive sugar molecule called fluorodeoxyglucose, or FDG, is used.~     It is believed that activated lymphocytes that may be found in patients disease might use~     more FDG because these cells burn more glucose fuel. Children younger than 18 years will not~     have PET scan done.~      This study may or may not have a direct benefit for participants. However, detailed~     assessments made throughout the study may provide information to help the doctors treat~     KSHV-MCD better.~   "
264067|NCT00091988|"~     PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized,~     controlled trial.~   "
264068|NCT00091975|"~     The objective of this study is to determine the safety and efficacy of Zemplar® Capsule~     versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney~     disease stage 5 subjects with secondary hyperparathyroidism on hemodialysis or peritoneal~     dialysis, while using the revised dose titration scheme.~   "
264069|NCT00091949|"~     The purpose of this study is to determine if pioglitazone is effective in preventing future~     strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke.~   "
264070|NCT00091923|"~     The objectives of the Spectacle Phase are:~        -  In previously untreated pure anisometropic patients (i.e. patients who have not used~          spectacles in the last year and who do not have strabismus), to determine~             1. the incidence of resolution of amblyopia with spectacle correction alone and~             2. the time course of visual acuity improvement with spectacle correction alone.~        -  In all other patients, to achieve maximal improvement with spectacle correction prior to~          entering the randomized trial.~      The objectives of the Randomized Trial are:~        -  To determine whether 5 weeks of patching treatment (2 hours of patching per day of the~          sound eye combined with at least one concurrent hour of near activities), compared with~          a control group (using spectacle correction only), improves visual acuity in patients~          with moderate to severe amblyopia (20/40 to 20/400).~        -  To determine the maximal improvement and time course of improvement with this patching~          treatment regimen.~   "
264071|NCT00091936|"~     Tuberculosis (TB), a bacterial infection common in HIV infected people, is a major problem in~     developing countries. The purpose of this study is to test the effectiveness of a combined~     treatment strategy using directly observed therapy (DOT) for HIV infected patients with TB.~     Participants will be recruited from resource-poor communities in Durban, South Africa.~   "
264072|NCT00091910|"~     Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to stimulate the~     production of red cells in the bone marrow. The purpose of this research study is to~     demonstrate that the administration EPO to critically ill subjects in the intensive care unit~     (ICU) reduces the number of patients requiring red blood cell (RBC) transfusion as compared~     with placebo (a liquid without active medicine).~   "
264073|NCT00091858|"~     The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in~     reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who~     are not receiving chemotherapy.~   "
264074|NCT00091845|"~     Although the serious form of West Nile Virus (WNV) disease, referred to as neuroinvasive~     disease, is rare, it can result in permanent disabilities and occasionally death. For~     patients who get this serious form of WNV disease, there are no approved specific treatment~     options.~      The purpose of this study is to test a new drug, AVI-4020 Injection, in patients who are~     hospitalized with recent symptoms of this form of WNV disease. In this study, we will~     determine if the AVI-4020 treatment is safe. This will be accomplished by reviewing the~     results of laboratory tests and clinical signs and symptoms. Additionally, we will review the~     patient data for signs that AVI-4020 is providing any beneficial effects against WNV~     neuroinvasive disease.~   "
264075|NCT00091832|"~     This study is to evaluate various doses and schedules for denosumab administration and~     characterize the safety profile in this indication.~   "
264076|NCT00091819|"~     Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and~     an approved drug, vancomycin, for the treatment of complicated skin and skin structure~     infections.~   "
264077|NCT00091806|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of two dose~     schedules of panitumumab in subjects with advanced solid tumors.~   "
264078|NCT00091793|"~     This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss~     in both early and late postmenopausal women with osteopenia, and to further test the safety~     and tolerability of AMG 162 in this population.~   "
264079|NCT00091897|"~     This study will test whether rituximab (RITUXAN (Trademark)) can relieve symptoms of stiff~     person syndrome (SPS), a progressive disease that causes stiffness of the muscles and muscle~     spasms induced by unexpected noises, touches, or stressful events. People with SPS may have~     certain proteins in their blood called anti-GAD antibodies that may cause some of the~     symptoms of the disease. Rituximab, a drug approved to treat lymphomas, targets certain white~     blood cells that produce antibodies. This study will see if rituximab can also be effective~     in patients with SPS who have high anti-GAD antibodies.~      Patients between 25 and 80 years of age with SPS may be eligible for this study. Candidates~     are screened with a medical history, physical examination, and blood tests. Participants~     undergo the following tests and procedures:~        -  Rituximab or placebo treatment: Patients are randomly assigned to receive two infusions~          by vein of either rituximab or placebo (a look-alike solution with no active ingredient)~          2 weeks apart. The infusions last from 3 to 4 hours, but may take as long as 16 hours if~          the rate must be slowed for any reason. Patients are followed monthly for up to 6 months~          and then every 2 months for up to 1 year after treatment.~        -  Medical history and interview, physical and neurological examinations: Patients are~          questioned about their vaccination history, medical, surgical, and psychiatric history,~          exposure to environmental toxins or viruses, and family and social history, including~          habits and employment.~        -  Blood drawing: Blood samples are collected before the two infusions and at all follow-up~          visits.~        -  Apheresis: For this procedure, which is used to collect white blood cells, blood is~          collected through a needle in an arm vein, similar to donating blood. The blood flows~          from the vein through a catheter (plastic tube) into a machine that separates it into~          its components by centrifugation (spinning). The white cells are removed and the rest of~          the blood (red cells, plasma and platelets) is returned to the body through a second~          needle in the other arm. The procedure takes about 60 to 90 minutes.~        -  Lumbar puncture (spinal tap): Lumbar puncture is done to sample a small amount of~          cerebrospinal fluid (CSF, the fluid that bathes the brain and spinal cord), for~          analysis. For this procedure, the patient is given a local anesthetic and a needle is~          inserted into the space between the bones in the lower back where the CSF circulates~          below the spinal cord. A small amount of fluid is withdrawn through the needle.~   "
264080|NCT00091884|"~     Some patients with HIV/AIDS suffer from a dangerous viral infection of the retina (and other~     organs) called cytomegalovirus infection (CMV). The medications currently used to treat CMV~     all have serious side effects. AIDS patients are prone to this infection because their immune~     system produces a lower number of CD4+T lymphocytes, the type of blood cells that fight viral~     infections.~      Some new HIV medications strengthen the immune system. This study will investigate the~     possibility that CMV patients on these HIV medications can develop immune systems strong~     enough to fight CMV without CMV medication. The study will enroll a maximum of 15 adult~     HIV/AIDS patients who have a CD4+T cell count over 150 cells/microliter and who have inactive~     CMV retinitis that is not immediately sight threatening. It is expected to last approximately~     2 years.~      Each prospective participant will have a physical examination and complete eye examination,~     including retina photographs, with the eye examination and retina photographs repeated 2~     weeks later. If there is no evidence of active CMV retinitis, the participant will be~     enrolled in the study, and CMV medication will be stopped. The participant will have physical~     and eye examinations every 2 weeks for the first 3 months of the study, and every 3 weeks for~     the next 3 months. After 6 months, the frequency of the examinations will be 2-8 weeks,~     depending on the participant's CD4 count. After one year, a participant with a CD4 count~     remaining over 150 cells/microliter may return to the care of a local ophthalmologist with~     HIV/CMV experience, revisiting the clinical center every 6 months. The participant's CMV~     medication will be restarted when CMV retinitis becomes active, which will terminate~     participation in the study.~   "
264081|NCT00091871|"~     Eosinophils are a type of white blood cell. Elevated eosinophil levels can damage the heart,~     nerves, and other organs, in the syndrome known as hypereosinophilic syndrome (HES). Some~     individuals have a hereditary form of HES known as familial eosinophilia (FE). More research~     on the causation and mechanisms of HES is needed in order to design more effective and less~     toxic therapies.~      This study will investigate FE and its genetic causes, damage mechanisms, and disease markers~     (such as blood test abnormalities). It will enroll approximately 20 individuals (both adults~     and children) from a previously studied family with FE. This is a long-term study of~     indefinite duration.~      Participants will undergo yearly clinical examinations including medical history, physical~     examination, bloodwork, EKG, echocardiogram, and pulmonary function tests, with additional or~     more frequent examinations and tests as required. In addition, participants will donate blood~     and tissue for research purposes. Both adult and child participants will donate blood. At the~     initial evaluation, adult participants will donate bone marrow. During the study, some adult~     participants will also undergo a limited number of leukaopheresis sessions, in which blood is~     donated from one arm, the blood is separated into red blood cells and other components, and~     the red blood cells are returned into the donor's other arm.~   "
264082|NCT00091780|"~     To test the hypothesis that breast arterial calcification (BAC) seen on mammograms can~     identify women with an increased risk of coronary artery disease (CAD).~   "
264083|NCT00091767|"~     To investigate genetic factors that affect asthma severity.~   "
264084|NCT00091754|"~     To identify new cellular, metabolic, and genomic correlates of atherosclerotic plaque and~     early pathologic changes in the vascular wall and determine their consequences for coronary~     heart disease and stroke.~   "
264085|NCT00091741|"~     The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the~     safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who~     have failed to respond to conventional antiretroviral (HAART) therapy and for whom no~     alternative therapy exists. The greatest challenge faced by HIV-treating clinicians today is~     the management of virologic failure and metabolic complications of anti-HIV treatment.~     Treatment failure can occur because of non-compliance, drug discontinuation, lack of drug~     potency, inadequate drug plasma concentration or drug resistance. Of these, drug resistance~     remains the single most important reason for virological failure and rapidly limits treatment~     options.~   "
264105|NCT00004083|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal cisplatin in treating~     patients who have recurrent ovarian cancer.~   "
264086|NCT00091728|"~     There are biological reasons to suspect that hormones may affect the risk of a woman becoming~     infected with a sexually transmitted disease. The evidence on this issue to date is mixed and~     previous studies have methodologic flaws making it difficult to draw conclusions about the~     results.~      This study compares the risk of developing either Chlamydial or Gonorrheal infection among~     three groups of women: those using combined oral contraceptives (birth control pills); those~     using the injectable hormone (brand name Depo Provera); and those women using non-hormonal~     contraceptive methods.~   "
264087|NCT00091715|"~     The present trial investigates a possible use of oral bosentan, which is currently approved~     for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to~     patients suffering from PAH Class II.~   "
264088|NCT00091702|"~     The purpose of this study is to compare two flu vaccines to determine their safety and~     ability to stimulate an immune response in HIV infected children and adolescents. This study~     will also determine how often and how long people who receive a vaccine are able to spread~     flu vaccine virus to other people.~   "
264089|NCT00091689|"~     Study 1501-852A is a Phase 1 Study with the objective of determining safety and the highest~     tolerated dose of an immune response modifier cream directly applied to advanced, inoperable,~     melanoma skin lesions. The study will also measure blood levels of the drug and examine the~     potential anti-tumor activity of the cream.~   "
264090|NCT00091676|"~     The primary objective of this Phase 3 study is to definitively confirm the safety and~     efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as~     measured by a significant prolongation of the period of disease free survival when~     administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their~     first complete remission.~   "
264091|NCT00091663|"~     This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with~     advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard~     chemotherapy treatment.~   "
264092|NCT00091637|"~     In the setting of reperfusion therapy in an acute myocardial infarction using primary~     percutaneous intervention (PCI), the body's own inflammatory system involving the complement~     cascade may be harmful. This study will test the safety and efficacy of a novel complement~     inhibitor, pexelizumab to reduce mortality at 30 days.~   "
264093|NCT00004905|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients who have chronic myelogenous~     leukemia or acute leukemia.~   "
264094|NCT00004209|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether three courses of combination chemotherapy are more effective than six~     courses of combination chemotherapy for non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of three courses of~     combination chemotherapy with that of six courses of combination chemotherapy in treating~     patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
264095|NCT00004195|"~     RATIONALE: Eniluracil may increase the effectiveness of chemotherapy by blocking tumor~     enzymes that break down chemotherapy drugs.~      PURPOSE: Randomized phase II trial to determine the effectiveness of eniluracil followed by~     surgery in treating patients who have primary or metastatic colorectal cancer.~   "
264096|NCT00004194|"~     RATIONALE: Fludarabine may be an effective treatment for graft-versus-host disease caused by~     bone marrow transplantation.~      PURPOSE: Phase I/II trial to study the effectiveness of fludarabine in treating patients who~     have chronic graft-versus-host disease that has not responded to steroid therapy.~   "
264097|NCT00004184|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in~     treating patients who have stage III or stage IV melanoma at high risk for recurrence~     following surgery to remove the tumor.~   "
264098|NCT00004172|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy. Combining chemotherapy with~     autologous peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to~     damage tumor cells.~      PURPOSE: Phase II trial to compare the effectiveness of two regimens of chemotherapy and~     filgrastim plus stem cell transplantation in treating patients who have previously untreated~     stage III or stage IV breast cancer.~   "
264099|NCT00091624|"~     A Phase I Study of CC-5013 in combination with Doxil, Vincristine and Decadron (DVd) in~     Subjects with Relapsed or Refractory Multiple Myeloma~   "
264100|NCT00091598|"~     The primary objective is to determine the effect of ambrisentan on exercise capacity in~     subjects with PAH.~   "
264101|NCT00091585|"~     The purpose of this study is to determine whether SNS-595 given intravenously once every 3~     weeks is safe.~   "
264102|NCT00091572|"~     The purpose of this study is to ascertain if the extended schedule of Temozolomide, which~     allows increased doses and potential depletion of the enzyme underlaying resistance, is a~     more effective treatment of metastatic melanoma than single agent dacarbazine.~   "
264103|NCT00091559|"~     A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher)~     who have progressive, persistent, or recurrent disease on or following 2 other therapies, one~     of which must have contained Targretin (bexarotene)or for patients who are not candidates or~     could not tolerate Targretin therapy.~   "
264104|NCT00004089|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have previously untreated anaplastic thyroid cancer.~   "
264106|NCT00004014|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating~     patients with prostate cancer that has not responded to hormone therapy.~   "
264107|NCT00003956|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of SCH 66336, fluorouracil, and leucovorin~     in treating patients who have advanced cancer.~   "
264108|NCT00003858|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy after surgery may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of mitoxantrone given after surgery in~     treating patients who have prostate cancer that is at high risk for recurrence.~   "
264109|NCT00003842|"~     RATIONALE: IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without~     harming normal cells. This may be an effective treatment for recurrent malignant astrocytoma.~      PURPOSE: Phase I trial to study the effectiveness of IL-4(38-37)-PE38KDEL immunotoxin in~     treating patients who have recurrent malignant astrocytoma.~   "
264110|NCT00003780|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies use different ways to stimulate the immune~     system and stop cancer cells from growing. It is not yet known whether chemotherapy is more~     effective than biological therapy in treating patients with cancer of the pancreas.~      PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with~     biological therapy in treating patients who have cancer of the pancreas that cannot be~     surgically removed.~   "
264111|NCT00003775|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of leflunomide in treating patients who~     have anaplastic astrocytoma in first relapse.~   "
264112|NCT00003714|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients~     who have unresectable primary or metastatic kidney cancer that has not been previously~     treated.~   "
264113|NCT00003711|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with pemetrexed~     disodium and irinotecan in treating patients who have metastatic solid tumors.~   "
264114|NCT00091611|"~     Background:~        -  Some patients with advanced kidney cancer have immune cells that can recognize and kill~          their cancer, but the cells are not active enough or numerous enough to accomplish this~          on their own.~        -  In recent studies of patients with advanced melanoma, some patients given special~          tumor-fighting cells (cells taken from the patient's tumor cells and grown in the~          laboratory) showed some anti-tumor response.~      Objectives:~      -To determine whether special tumor-fighting cells taken from the patient's blood or tumor~     and grown in the laboratory can cause tumors in patients with kidney cancer to shrink when~     they are given back to the patient along with interleukin-2.~      Eligibility: Patients 18 years of age or older with advanced kidney cancer.~      Design:~        -  Up to 29 patients will be treated in this study.~        -  Patients undergo tumor biopsy to collect tumor cells for creating special tumor-fighting~          cells for later infusion.~        -  Patients undergo apheresis to collect stem cells for later re-infusion. For apheresis,~          whole blood is collected through a needle in an arm vein and circulated through a~          cell-separating machine where the stem cells are extracted. The rest of the blood is~          returned through the same needle or a needle in the other arm.~        -  Before receiving the treated white cells, patients are given two drugs to suppress the~          immune system so the treated cells can work without interference from immune system~          cells. They are given cyclophosphamide over 2 days through a catheter (plastic tube~          inserted into a vein in the arm or neck) and fludarabine through the catheter over 15-30~          minutes for the next 5 days.~        -  The day after the last dose of fludarabine, the tumor-fighting cells are infused through~          a vein over 10-20 minutes.~        -  Following the cell infusion, patients start treatment with high-dose interleukin-2 every~          8 hours for a maximum of 12 doses.~        -  Patients are evaluated with x-ray studies about 1 month after receiving the cells and~          interleukin 2 (IL-2) to look for tumor response to treatment. Those who show significant~          improvement continue to receive treatment until the treated cells are used up or the~          patient no longer benefits or develops unacceptable side effects.~   "
264115|NCT00091546|"~     The goal of this study is to identify the modifying genes and environmental features that~     regulate the clinical expression of mutations in bone morphogenetic protein receptor 2~     (BMPR2); to develop the understanding of how BMPR2 mutations result in disease; and to~     identify the undiscovered genetic mutations that cause primary pulmonary hypertension (PPH).~   "
264116|NCT00091507|"~     The purpose of this study is to test the impact of pharmacological myocardial metabolic~     support, in the form of intravenous (IV) glucose, insulin and potassium (GIK), for the~     treatment of patients with threatened or established acute myocardial infarction (AMI).~   "
264117|NCT00091494|"~     To investigate how inflammation, hemostasis, and stress may contribute to neighborhood and~     individual-level socioeconomic differences in cardiovascular risk.~   "
264118|NCT00091481|"~     To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between~     two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline~     iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).~   "
264119|NCT00091442|"~     The purpose of the study is to evaluate whether the time to progression for the DOXIL and~     docetaxel combination therapy group was superior to that of the group treated with docetaxel~     monotherapy in participants with advanced breast cancer.~   "
264120|NCT00004057|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel and L-778,123 in~     treating patients who have recurrent or refractory solid tumors or lymphomas.~   "
264121|NCT00004036|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumors from dividing so they~     stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from~     the side effects of chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of amifostine plus combination chemotherapy~     in treating patients with advanced cancer.~   "
264122|NCT00004022|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Combining different types of biological therapies may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery in~     treating patients who have stage III or stage IV melanoma.~   "
264837|NCT00086372|"~     This is a long-term follow-up study of people who are identified during acute or recent HIV~     infection and are being followed at clinical research sites associated with the Acute HIV~     Infection and Early Disease Research Program (AIEDRP).~   "
264123|NCT00003673|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating older patients who~     have acute myeloid leukemia that has recurred for the first time following at least 3 months~     of complete remission.~   "
264124|NCT00003671|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     children who have newly diagnosed acute lymphocytic leukemia.~   "
264125|NCT00003666|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with~     relapsed or refractory non-small cell lung cancer.~   "
264126|NCT00003634|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. It is not yet known whether~     giving monoclonal antibody therapy is more effective than a placebo in treating patients with~     ovarian epithelial, fallopian tube, or peritoneal cancer who have responded to surgery and~     chemotherapy.~      PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy~     in treating patients with residual disease from stage III or stage IV ovarian epithelial,~     fallopian tube, or peritoneal cancer following surgery and chemotherapy.~   "
264127|NCT00003625|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients with newly diagnosed brain stem glioma.~   "
264128|NCT00003599|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of isotretinoin may be an effective way to~     prevent lung cancer. Vitamin E may prevent the side effects of isotretinoin therapy.~      PURPOSE: Randomized clinical trial to study the effectiveness of vitamin E in preventing the~     side effects of isotretinoin in former and current smokers who are receiving isotretinoin to~     prevent lung cancer.~   "
264129|NCT00003591|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in~     treating patients who have nonmetastatic, unresectable pancreatic cancer.~   "
264130|NCT00003587|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of two different combination~     chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell~     lung cancer~   "
264131|NCT00003564|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether giving procarbazine alone or with isotretinoin is more effective for~     recurrent primary malignant glioma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or~     with isotretinoin in treating patients with recurrent primary malignant gliomas.~   "
264132|NCT00003551|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients~     with stage III, stage IV, or recurrent kidney cancer.~   "
264133|NCT00003546|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus radiation therapy in~     treating patients with pancreatic cancer that cannot be removed surgically.~   "
264134|NCT00003451|"~     Phase I trial to study the effectiveness of combining interleukin-12 and interferon alfa in~     treating patients who have residual, recurrent, or metastatic malignant melanoma or other~     advanced cancer that has not responded to standard therapy. Interleukin-12 may stimulate a~     person's white blood cells to kill cancer cells. Interferon alfa may interfere with the~     growth of the cancer cells. Combining interleukin-12 with interferon alfa may kill more~     cancer cells.~   "
264135|NCT00003441|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with~     metastatic colorectal cancer.~   "
264136|NCT00003430|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of L-778,123 in treating patients with~     recurrent or refractory solid tumors.~   "
264137|NCT00003428|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     arzoxifene hydrochloride may fight breast cancer by blocking the use of estrogen by the tumor~     cells.~      PURPOSE: This randomized phase II trial is comparing two different doses of arzoxifene~     hydrochloride to see how well it works in treating women with advanced or metastatic breast~     cancer.~   "
264138|NCT00003353|"~     RATIONALE: High-dose chemotherapy may destroy the amyloid-producing cells in bone marrow.~     Peripheral stem cell transplantation~      PURPOSE: Phase II trial to study the effectiveness of high dose melphalan plus peripheral~     stem cell transplantation in treating patients who have primary systemic amyloidosis.~   "
264139|NCT00003344|"~     RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus irinotecan in~     treating patients with colon cancer that is recurrent or that cannot be removed surgically.~   "
264140|NCT00003339|"~     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune~     response that will kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood~     flow to the tumor and by stimulating white blood cells to kill melanoma cells.~      PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy given~     with interleukin-12 in treating patients who have stage III or stage IV melanoma.~   "
264141|NCT00003331|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining topotecan, fluorouracil, and~     leucovorin in treating patients who have advanced cancer.~   "
264142|NCT00003288|"~     Phase I trial to study the effectiveness of tirapazamine plus cyclophosphamide in treating~     children who have refractory solid tumors. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may~     kill more tumor cells.~   "
264143|NCT00003263|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy,~     radiation therapy, and interferon alfa may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of cisplatin plus interferon alfa followed~     by surgery and interferon alfa plus radiation therapy in treating patients with malignant~     pleural mesothelioma.~   "
264144|NCT00091533|"~     This study will examine activity in the brain during the observation of touch. Studies with~     animals have shown that mirror neurons, or nerve cells, are active during the observation and~     performance of an action. The researchers for this study hypothesize that a similar system~     pertains to observing and experiencing touch.~      Patients ages 18 to 75 years old who are in good health, are right handed, and who are able~     to perform simple tasks that require attention may be eligible for this study. Pregnant women~     are not eligible.~      Patients who have not had a health screening at NIH will undergo a clinical and neurological~     exam. Women of childbearing potential will also have a pregnancy test. The screening will~     take about 2 to 3 hours. A diagnostic magnetic resonance imaging (MRI) scan will be performed~     if patients have not undergone one in the previous 12 months. During the procedure, patients~     will lie still on a table that will slide into the enclosed tunnel of the scanner. They will~     be asked to lie as still as possible for up to a few minutes at a time. As the scanner takes~     pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to~     reduce the noise. Patients will be able to communicate with the MRI staff at all times during~     the scan, and they may ask to be moved out of the machine at any time. This scan will take~     about 2 hours.~      Two sessions are involved in the study. The first one is intended to familiarize patients~     with the procedure. During it, they will learn about hand stimulus, through watching a video~     showing the index finger of a hand being touched by a stick repeatedly. Then the activity~     will be repeated, but this time, a researcher will also touch the patient's index finger~     while he or she is watching the video. This session will take about 1 hour.~      The second session consists of a functional MRI scan, or fMRI. During it, pictures of the~     brain will be taken while patients perform tasks. All tasks will be explained in advance, and~     patients will have an opportunity to practice them before entering the scanner. The fMRI scan~     will take 1 to 2 hours.~      The researchers will discuss the results of the tests with the participants. There is not a~     direct benefit to those who take part in the study. However, it is hoped that resulting~     information will enhance researchers' understanding about how the brain processes observed~     information.~   "
264145|NCT00091429|"~     The study will be a multi-national, double-blind, randomized, placebo-controlled, parallel~     group study to evaluate the effectiveness of ranolazine (1000 mg twice daily) in~     approximately 500 patients with chronic angina who remain symptomatic despite daily treatment~     with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved~     for the treatment of chronic angina. Eligible patients will be randomized to receive~     ranolazine 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of~     amlodipine. Participation in the study will last approximately 3 months.~   "
264146|NCT00003257|"~     RATIONALE: Inserting the gene for p53 into a person's tumor may improve the body's ability to~     fight cancer or make the cancer more sensitive to chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who~     have recurrent head and neck cancer.~   "
264147|NCT00003252|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells~     from the side effects of chemotherapy.~      PURPOSE: Phase IV trial to study the effectiveness of amifostine in treating patients with~     cancer who have neurological changes caused by chemotherapy.~   "
264148|NCT00003248|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Combining~     monoclonal antibody therapy with chemotherapy may kill more cancer cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine given with or~     without monoclonal antibody therapy followed by monoclonal antibody therapy alone in treating~     patients who have untreated B-cell chronic lymphocytic leukemia.~   "
264149|NCT00003241|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of phenylacetate in treating children with~     recurrent or progressive brain tumors.~   "
264150|NCT00003223|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of fenretinide may be an effective way to~     prevent the development of cancer in patients with neoplasia of the mouth.~      PURPOSE: Phase II trial to study the effectiveness of fenretinide in preventing cancer in~     patients who have neoplasia of the mouth.~   "
264151|NCT00091416|"~     The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine,~     VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who~     participated in HVTN 052.~   "
264152|NCT00091390|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.~     Internal radiation therapy uses radioactive material placed directly into or near a tumor to~     kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving internal radiation therapy together~     with external-beam radiation therapy works in treating patients with stage II or stage III~     prostate cancer.~   "
264181|NCT00090896|"~     RATIONALE: Biological therapies, such as CP-675,206, work in different ways to stimulate the~     immune system and stop tumor cells from growing. Vaccines may make the body build an immune~     response to kill tumor cells. Combining CP-675,206 with vaccine therapy may cause a stronger~     immune response and kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of CP-675,206 when~     given with vaccine therapy in treating patients with stage III or stage IV melanoma that~     cannot be removed with surgery.~   "
264153|NCT00091377|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Phenoxodiol may help~     cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the~     drugs.~      PURPOSE: This randomized phase I/II trial is studying the side effects of phenoxodiol when~     given together with either cisplatin or paclitaxel and to see how well they work in treating~     patients with recurrent late-stage ovarian epithelial cancer, fallopian tube cancer, or~     primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel,~     docetaxel, cisplatin, or carboplatin.~   "
264154|NCT00091351|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     therapy before surgery may shrink the tumor so that it can be removed. It is not yet known~     whether surgery is more effective with or without radiation therapy.~      PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works~     compared to radiation therapy together with surgery in treating patients with primary soft~     tissue sarcoma of the retroperitoneum or pelvis.~   "
264155|NCT00091338|"~     RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells.~     Vaccines made from peptides may make the body build an immune response to kill tumor cells.~     Combining interleukin-7 with vaccine therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when~     given with vaccine therapy in treating patients with metastatic melanoma.~   "
264156|NCT00091325|"~     RATIONALE: Green tea extract (Polyphenon E) contains ingredients that may prevent the~     development of cancer.~      PURPOSE: This phase I trial is studying how well green tea extract works in preventing cancer~     in healthy participants.~   "
264157|NCT00091312|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work~     in different ways to stop tumor cells from dividing so they stop growing or die. Combining~     more than one drug and giving them after surgery may kill any remaining tumor cells. It is~     not yet known whether combination chemotherapy is more effective than observation alone in~     treating patients who have undergone surgery for colon cancer.~      PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or~     without leucovorin to see how well they work compared to observation alone in treating~     patients who have undergone surgery for stage II colon cancer.~   "
264158|NCT00091299|"~     RATIONALE: Vatalanib may stop the growth of tumor cells by stopping blood flow to the tumor.~     Warfarin may be effective in preventing the formation of blood clots in patients who are~     undergoing treatment for advanced solid tumors.~      PURPOSE: This phase I trial is studying how well giving warfarin together with vatalanib~     works in treating patients with advanced solid tumors.~   "
264159|NCT00091286|"~     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill~     tumor cells.~      PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients~     with stage IIB, stage III, or stage IV colorectal cancer.~   "
264160|NCT00091273|"~     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating~     patients with ovarian epithelial or primary peritoneal cancer.~   "
264161|NCT00091260|"~     RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary~     systemic amyloidosis.~      PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without~     dexamethasone in treating patients with primary systemic amyloidosis.~   "
264162|NCT00091247|"~     RATIONALE: Tetracycline may be effective in preventing skin rash that is caused by treatment~     with drugs such as gefitinib or cetuximab.~      PURPOSE: This randomized clinical trial is studying tetracycline to see how well it works~     compared to placebo in preventing skin rash in patients who are receiving drugs such as~     gefitinib or cetuximab for cancer.~   "
264163|NCT00091234|"~     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     It is not yet known whether gemtuzumab ozogamicin is more effective than standard supportive~     care in treating older patients who have acute myeloid leukemia.~      PURPOSE: This randomized phase II/III trial is studying two different gemtuzumab ozogamicin~     regimens to see how well they work compared to standard supportive care in treating older~     patients with previously untreated acute myeloid leukemia.~   "
264164|NCT00091195|"~     This phase II trial is studying how well depsipeptide (romidepsin) works in treating patients~     with recurrent ovarian epithelial or peritoneal cavity cancer. Drugs used in chemotherapy,~     such as depsipeptide (romidepsin), work in different ways to stop tumor cells from dividing~     so they stop growing or die. Depsipeptide (romidepsin) may also stop the growth of ovarian~     epithelial or peritoneal cavity cancer by stopping blood flow to the tumor and by blocking~     the enzymes necessary for their growth~   "
264165|NCT00091182|"~     This phase II trial is studying how well oxaliplatin works in treating young patients with~     recurrent solid tumors that have not responded to previous treatment. Drugs used in~     chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing~     so they stop growing or die.~   "
264166|NCT00091169|"~     RATIONALE: Levocarnitine may help improve energy levels in cancer patients.~      PURPOSE: This randomized phase III trial is studying how well levocarnitine works compared to~     a placebo in treating fatigue in cancer patients.~   "
264167|NCT00091156|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. It is not yet known whether giving gefitinib after initial chemotherapy is~     effective in delaying the recurrence of non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works~     compared to placebo in delaying tumor recurrence in patients who have undergone initial~     chemotherapy for stage IIIB or stage IV non-small cell lung cancer.~   "
264182|NCT00090870|"~     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.~     Colony-stimulating factors such as sargramostim may increase the number of immune cells found~     in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping~     blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with~     sargramostim and thalidomide works in treating patients with metastatic kidney cancer.~   "
264168|NCT00091143|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Vaccines made from peptides may make~     the body build an immune response to kill tumor cells. Infusions of a person's white blood~     cells may be able to replace immune cells that were destroyed by chemotherapy. Combining~     fludarabine with vaccine therapy and white blood cell infusions may kill more tumor cells.~      PURPOSE: This randomized phase I trial is studying the side effects of giving vaccine therapy~     together with fludarabine and white blood cell infusions and to see how well it works in~     treating patients with unresectable or metastatic melanoma.~   "
264169|NCT00091130|"~     This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a~     placebo in treating human papillomavirus and preventing cervical cancer in patients with~     abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune~     response to kill human papillomavirus and abnormal cervical cells and may be effective in~     preventing cervical cancer~   "
264170|NCT00091117|"~     Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their~     growth. This phase I trial is studying the side effects and best dose of bortezomib in~     treating patients with advanced cancer and liver dysfunction.~   "
264171|NCT00091104|"~     RATIONALE: Inserting a laboratory-treated gene into a person's white blood cells may make the~     body build an immune response to kill tumor cells. Giving cyclophosphamide and fludarabine~     before a white blood cell infusion may suppress the immune system and allow tumor cells to be~     killed. Vaccines may make the body build an immune response to kill tumor cells. Aldesleukin~     may stimulate a person's white blood cells to kill tumor cells. Combining white blood cell~     infusion with vaccine therapy and aldesleukin may cause a stronger immune response and kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of gene-modified white~     blood cells when given together with cyclophosphamide, fludarabine, vaccine therapy, and~     aldesleukin and to see how well it works in treating patients with metastatic melanoma.~   "
264172|NCT00091091|"~     RATIONALE: Assessing the long-term effects of cancer treatment in cancer survivors may help~     improve the ability to plan effective treatment and follow-up care.~      PURPOSE: This clinical trial is studying the long-term effects of treatment in patients who~     were previously treated for childhood Hodgkin's lymphoma.~   "
264173|NCT00091078|"~     Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Oblimersen may help imatinib mesylate kill more tumor cells by making tumor~     cells more sensitive to the drug. This phase II trial is studying how well giving imatinib~     mesylate together with oblimersen works in treating patients with advanced gastrointestinal~     stromal tumor that cannot be removed by surgery.~   "
264174|NCT00091052|"~     RATIONALE: Colony-stimulating factors such as sargramostim increase the number of immune~     cells found in bone marrow or peripheral blood. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Combining radiation therapy with sargramostim may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving radiation therapy~     together with sargramostim and to see how well it works in treating patients with advanced~     solid tumors.~   "
264175|NCT00091039|"~     RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune~     response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin,~     work in different ways to stop tumor cells from dividing so they stop growing or die.~     Radiation therapy uses high energy x-rays to damage tumor cells. Combining vaccine therapy~     with chemotherapy and radiation therapy may kill more tumor cells.~      PURPOSE: This clinical trial is studying how well giving vaccine therapy together with~     paclitaxel, carboplatin, and radiation therapy works in treating patients with stage III~     non-small cell lung cancer that cannot be removed with surgery.~   "
264176|NCT00091026|"~     This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how~     well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with~     advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can~     locate tumor cells and either kill them or deliver tumor-killing substances to them without~     harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways~     to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth~     of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and~     gemcitabine with either cetuximab or erlotinib may kill more tumor cells.~   "
264177|NCT00090987|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes~     necessary for their growth.~      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating~     patients with HIV-related Kaposi's sarcoma.~   "
264178|NCT00090974|"~     RATIONALE: Quality-of-life assessment in postmenopausal women who are receiving hormone~     therapy for breast cancer may help to determine the effects of treatment on these patients~     and may improve the quality of life for future breast cancer patients.~      PURPOSE: This clinical trial is studying quality of life of postmenopausal women who are~     receiving either exemestane or anastrozole with or without celecoxib for stage I, stage II,~     or stage IIIA primary breast cancer.~   "
264179|NCT00090961|"~     RATIONALE: Pulmonary rehabilitation education and exercise training may improve physical~     function and quality of life in patients who are receiving treatment for lung cancer.~      PURPOSE: This randomized clinical trial is studying pulmonary rehabilitation education and~     exercise training to see how well they work compared to exercise training alone in improving~     physical function and quality of life in patients who are undergoing chemotherapy and~     radiation therapy for locally advanced lung cancer.~   "
264180|NCT00090909|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and dexamethasone,~     work in different ways to stop cancer cells from dividing so they stop growing or die.~     Combining more than one drug may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together~     with dexamethasone works in treating patients with relapsed or refractory Hodgkin's lymphoma.~   "
264183|NCT00090857|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Letrozole may be effective in preventing the development~     or recurrence of breast cancer in postmenopausal women who are at increased risk of~     developing breast cancer because of elevated estradiol levels.~      PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing~     breast cancer in postmenopausal women with elevated estradiol levels.~   "
264184|NCT00090844|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect~     normal ovarian cells from the side effects of chemotherapy.~      PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving~     ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast~     cancer.~   "
264185|NCT00090831|"~     This study will examine the role of serotonin function in the brain. Serotonin, one of the~     brain's natural chemicals, connects with receptors on brain cells to regulate emotion,~     anxiety, sleep, stress hormones, and other body functions that are disturbed in various mood~     and anxiety disorders. Also, the research will look at the function of particular brain~     areas, how they are involved in regulating emotions, and how serotonin is involved in the~     regulation of their function. The procedures entailed are tryptophan depletion and magnetic~     resonance imagining (MRI). Also, researchers' understanding of the genetic causes of mood and~     anxiety disorders will increase through examination of participants' DNA.~      Adults in good health, ages 20 through 50, may be eligible for this study. Among those not~     eligible are females who are pregnant or breast feeding, patients with psychiatric or central~     nervous system disease, and those taking medications that would interfere with study results.~      At the first visit, patients will be asked about their general mood, degree of nervousness,~     thinking skills, and behavior. The session will last from 1.5 to 2.0 hours. A blood sample of~     about 2 tablespoons will be drawn, for DNA study.~      Participants will undergo the following procedures and tests:~        -  Physical examination.~        -  Test of vital signs, lying and standing.~        -  Electrocardiogram.~        -  Collection of blood for chemistry and hematology.~        -  Urinalysis.~        -  HIV, urine drug, and hepatitis screening.~        -  Psychiatric screening.~        -  (SqrRoot) -HCG pregnancy test, if applicable.~      At the second visit, patients will receive either tryptophan depletion or placebo, and 5~     hours later, the study will begin, to last up to 2 additional hours. Patients will be asked~     periodically about their emotional state or changes in their well-being. The MRI system will~     create images of the brain's blood flow and measure glucose metabolism as a measure of brain~     activity. During the MRI scan, patients will hear knocking or beeping sounds, and they will~     wear earplugs to reduce the noise. Patients will be able to communicate with the MRI staff at~     all times during the scan, and they may ask to be moved out of the machine at any time. The~     MRI session lasts up to 1.5 hours.~      Results of any medical tests or other information will not be provided to participants,~     because further research may be needed before such results are meaningful. But if meaningful~     information develops from this study that may be important for a participant's health, he or~     she will be notified about it when it becomes available.~   "
264186|NCT00090818|"~     This study will screen patients for eligibility in studies sponsored by the Craniofacial~     Genetics Section (HCGS), the Clinical Research Core (CRC), and other branches located within~     the National Institute of Dental and Craniofacial Research (NIDCR). It will also evaluate~     patients with diseases or abnormalities of the oral cavity or craniofacial complex, or both,~     for future protocol development. HCGS and CRC study the natural history of oral diseases and~     systemic diseases that are manifested in the maxillofacial region-the upper jaw and face.~     Among the diseases are lichen planus, systemic lupus erythematosus, and premalignant oral~     leukoplakia. Researchers also study certain acquired diseases and genetic diseases. Because~     many of the diseases of the maxillofacial region are poorly defined, the evaluation and~     characterization of patients with such diseases are goals of investigation.~      Patients of any age, gender, and racial and ethnic group who have oral diseases or systemic~     diseases of the upper jaw and face may be eligible for the study. Women of childbearing~     potential, or who are pregnant or lactating, may be eligible; they would undergo procedures~     and tests or receive medications posing a minimal risk to the fetus or child.~      Participants will undergo the following procedures:~        -  Complete medical history and physical examination, including a thorough examination of~          the head and neck; detailed examination of the teeth and gums may or may not be~          necessary.~        -  Tests of blood, urine, stool; tests for pregnancy and HIV when needed; and tests for~          cultures, fungi, bacteria, and parasites.~        -  Sampling of blood and oral tissues for diagnosis, treatment response, and disease~          progression.~        -  Electrocardiogram, x-ray, and imaging procedures, including imaging of the face.~      Biopsies may be performed as needed for diagnosis and to guide therapy. The type, number,~     location, and frequency of biopsies depend on several factors, including the nature of the~     disease being evaluated. Local anesthesia is typically used unless there are~     contraindications. Some biopsies are done with disposable, 2 to 3 mm, round, sharp metal~     punches. Larger excisions with the use of an appropriate blade may be necessary for proper~     evaluation of a patient's condition or complete removal of something that is abnormal. The~     risks and discomfort associated with any of the interventions include mild pain, bleeding,~     and infection; there may be temporary facial paralysis, bruising, and allergic reactions.~      Supportive care will be given as needed, according to the patient's diagnosis, treatment, and~     clinical information. Disease-related or drug-related complications, or both, will be managed~     through collaboration with the patient's referring physician.~   "
264187|NCT00090779|"~     Although some doctors favor starting anti-HIV treatment as soon as possible after patients~     learn they are infected, it is not known if treatment for recently infected patients results~     in long-term benefits or harm. The purpose of this study is to learn whether or not people~     should take anti-HIV drugs when they are first infected.~   "
264188|NCT00090766|"~     This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid~     organ transplant recipients. The anticipated time on study treatment is 3-12 months and the~     target sample size is less than 100 individuals.~   "
264189|NCT00090753|"~     This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or~     subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients~     with renal anemia. Eligible patients were those who were receiving stable maintenance therapy~     with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in~     Phase II or III clinical studies. They continued to receive methoxy polyethylene~     glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of~     administration (sc or iv) as in the qualifying studies.~   "
264190|NCT00090740|"~     The purpose of this study is to determine whether a specific genetic factor influences the~     severity of asthma symptoms.~   "
264191|NCT00090727|"~     The purposes of this study are to determine:~        -  the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4~          week cycle~        -  the side effects of AQ4N when given on the above schedule~        -  how much AQ4N is in the blood and urine at specific times after administration and how~          the body get rids of AQ4N~        -  if AQ4N helps treat cancer~   "
264192|NCT00090714|"~     The purpose of this study is to determine the optimum effective dose of recombinant plasmid~     DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection~     catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.~   "
264193|NCT00090701|"~     The primary objective of this study is to determine safety and activity of a novel anticancer~     agent in patients with metastatic non-small cell lung cancer who failed 2 or 3 prior systemic~     treatments.~   "
264194|NCT00003217|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of~     methotrexate and cyclophosphamide in treating children who have stage III or stage IV~     non-Hodgkin's lymphoma or acute lymphoblastic leukemia.~   "
264195|NCT00003172|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs in different combinations and combining them with~     interferon alfa and G-CSF may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of different combination~     chemotherapy regimens in treating patients with advanced stomach cancer.~   "
264196|NCT00003170|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Glutamine may be~     an effective treatment for acute diarrhea caused by radiation therapy. It is not known if~     glutamine is an effective treatment for acute diarrhea caused by radiation therapy.~      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of~     glutamine in preventing acute diarrhea in patients who have pelvic cancer and who are~     receiving radiation therapy.~   "
264197|NCT00003139|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     pilocarpine may protect normal cells from the side effects of radiation therapy. It is not~     yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients~     receiving radiation therapy for head and neck cancer.~      PURPOSE: Randomized, double-blinded, phase III trial to study the effectiveness of~     pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for~     head and neck cancer.~   "
264198|NCT00003134|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have recurrent glioma.~   "
264199|NCT00003100|"~     RATIONALE: Eating a diet rich in soy foods appears to reduce the risk of some types of~     cancer. Isoflavones are compounds found in soy food that may prevent the development of~     cancer.~      PURPOSE: Clinical trial to determine the most effective amount and type of soy isoflavones~     needed in the diets of healthy men and women to prevent cancer.~   "
264200|NCT00003088|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs at different times or combining more than one drug may~     kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for~     breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting~     of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of~     combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by~     paclitaxel in treating women with stage II or stage IIIA breast cancer.~   "
264201|NCT00003072|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving the drugs in different~     combinations may kill more tumor cells.~      PURPOSE: Randomized phase II double-blinded trial to study the effectiveness of paclitaxel~     and carboplatin given with either amifostine or placebo in patients with metastatic stage III~     or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer.~   "
264202|NCT00003048|"~     RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.~      PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with~     myelodysplastic syndrome.~   "
264203|NCT00003039|"~     Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent~     intermediate-grade or high-grade non-Hodgkin's lymphoma or mantle cell lymphoma. Drugs used~     in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die.~   "
264204|NCT00090688|"~     The study will enroll approximately 60 volunteers. The vaccine is given as a drink in~     flavored soda water. Volunteers will either receive a 3-dose vaccination with doses spaced~     two weeks apart or a 4-dose vaccination with doses spaced 2 days apart depending upon their~     availability for follow-up.~      Once assigned to a vaccination schedule, volunteers will be randomly assigned to receive the~     meCS6 vaccine with or without the mLT adjuvant for all vaccine doses. Neither the study~     investigators nor the volunteers will know which group they are assigned.~      Volunteers will be asked to be available for clinic visits and telephone follow-ups during~     the study period and provide blood and stool specimens for testing.~   "
264205|NCT00090675|"~     In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced~     or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV)~     who have SD or objective tumor response immediately following the completion of 4-6 cycles of~     front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner~     to receive either ZD1839 or placebo.~   "
264206|NCT00003005|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin~     plus pentostatin in treating patients with refractory acute lymphocytic or chronic~     myelogenous leukemia.~   "
264207|NCT00002993|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with~     mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer~     of the uterus.~   "
264208|NCT00002980|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with~     stage III or stage IV melanoma or other advanced cancer that has not responded to previous~     therapy.~   "
264209|NCT00002967|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor~     cells.~      PURPOSE: Randomized phase III trial to study the effectiveness of tamoxifen, octreotide, and~     chemotherapy in treating women who have stage I or stage II breast cancer.~   "
264210|NCT00002946|"~     Phase I trial to study the effectiveness of penclomedine in treating patients with malignant~     solid tumors or lymphomas. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die.~   "
264211|NCT00002942|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation~     or peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy drugs and kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare bone marrow transplantation with peripheral~     stem cell transplantation following carboplatin in treating patients with breast cancer.~   "
264331|NCT00089999|"~     This phase II study will evaluate and compare the efficacy and tolerability of two dose~     schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with~     advanced or metastatic breast cancer.~   "
264212|NCT00002937|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel with or without~     PSC 833 in treating patients with metastatic breast cancer.~   "
264213|NCT00002932|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cisplatin and radiation therapy in~     treating patients with stage IV cancer of the head and neck.~   "
264214|NCT00002904|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults~     with advanced solid tumors.~   "
264215|NCT00002897|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not known whether chemotherapy before surgery is more~     effective than surgery alone in treating cancer of the esophagus.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without~     chemotherapy in treating patients with stage II or stage III cancer of the esophagus.~   "
264216|NCT00090662|"~     Increased numbers of white blood cells called eosinophils can cause disease. To investigate~     this disease, researchers need normal blood and bone marrow samples to compare to samples~     from patients with this problem. This study will collect blood and bone marrow samples from~     normal volunteers who meet standard blood donor criteria. Some of the samples will be used~     for genetic testing or future research.~      This study will last for about 3 years and will include a maximum of 50 paid volunteers ages~     18 to 65.~      After a medical screening, volunteers will donate a blood sample and a bone marrow sample,~     taken from the hip bone, followed by a biopsy that will obtain a small sample of bone and~     bone marrow. The procedure lasts less than 1 hour. Volunteers may donate repeatedly within~     the limits set by the study.~   "
264217|NCT00002873|"~     RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.~      PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who~     have stage I or stage II breast cancer.~   "
264218|NCT00002872|"~     RATIONALE: Some drugs such as bleomycin or doxycycline, or other compounds like talc, may~     help to control fluid in the chest caused by cancer. It is not yet known if bleomycin,~     doxycycline, or talc is more effective in treating patients with malignant pleural effusions.~      PURPOSE: Randomized phase III trial to compare the effectiveness of bleomycin, doxycycline,~     or talc in treating patients with malignant pleural effusions.~   "
264219|NCT00002811|"~     RATIONALE: Patients with xeroderma pigmentosum are more likely to develop skin lesions in~     sun-affected areas. These skin lesions, such as actinic keratoses, can develop into skin~     cancer. T4N5 liposome lotion may reduce actinic keratoses or other sun-induced skin damage in~     patients with xeroderma pigmentosum.~      PURPOSE: Randomized double-blinded phase III trial to compare treatment using T4N5 liposome~     lotion with treatment using placebo in reducing actinic keratoses and other sun-induced skin~     damage in patients with xeroderma pigmentosum.~   "
264220|NCT00002805|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did~     not achieve first remission.~   "
264221|NCT00002793|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug or giving the drugs in different ways~     may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy administered~     via an implantable pump with a subcutaneous port for unresectable liver metastases in~     patients with resected primary colorectal cancer.~   "
264222|NCT00002791|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with more than one chemotherapy drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy followed by surgery in treating patients who have soft tissue sarcoma.~   "
264223|NCT00002790|"~     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were~     destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make~     an immune response against the body's normal tissues. Treatment with sirolimus, methotrexate,~     and cyclosporine may prevent this from happening.~      PURPOSE: Phase I/II trial to study the effectiveness of sirolimus plus methotrexate and~     cyclosporine in preventing graft-versus-host disease in patients with hematologic~     malignancies who are receiving a bone marrow transplant.~   "
264224|NCT00002781|"~     RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming~     normal tissue.~      PURPOSE: Phase I trial to study the effectiveness of boron neuron capture therapy in treating~     patients with stage III melanoma.~   "
264225|NCT00002775|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel and estramustine~     in treating patients who have metastatic prostate cancer.~   "
264226|NCT00002767|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make~     the body build an immune response to kill tumor cells. It is not yet known whether melanoma~     vaccine plus interferon alfa is more effective than interferon alfa alone in treating~     patients with metastatic melanoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or~     without vaccine therapy in treating patients with metastatic melanoma.~   "
264227|NCT00090649|"~     To compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in~     adult outpatients with MDD.~   "
264228|NCT00090623|"~     This is a phase III, multicenter, randomized, double masked, sham injection-controlled study~     of the efficacy and safety of intravitreally administered ranibizumab in subjects with~     subfoveal choroidal neovascularization secondary to age-related macular degeneration.~   "
264229|NCT00002744|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug and giving them in different ways~     may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is~     more effective for acute lymphoblastic leukemia~      PURPOSE: Randomized phase III trial to compare different regimens of combination chemotherapy~     in treating children who have newly diagnosed acute lymphoblastic leukemia.~   "
264230|NCT00002735|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation~     therapy in treating patients with stage III or stage IV cancer of the hypopharynx or tongue.~   "
264231|NCT00002730|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining~     buthionine sulfoximine with chemotherapy may reduce resistance to the drug and allow more~     tumor cells to be killed.~      PURPOSE: Phase I trial to study the effectiveness of melphalan, buthionine sulfoximine, and~     G-CSF in treating children with progressive neuroblastoma that has not responded to previous~     therapy.~   "
264232|NCT00002703|"~     RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of conventional radiation~     therapy with high-dose radiation therapy in treating men with stage I or stage II prostate~     cancer.~   "
264233|NCT00090610|"~     The purpose of this study is to compare the progression-free survival of two treatment~     regimens for relapsed ovarian cancer.~   "
264234|NCT00090584|"~     The primary aim of this study is to test if the addition of behavioral treatment to drug~     therapy for the treatment of urge incontinence will increase the number of patients who can~     discontinue drug therapy and sustain a significant reduction of incontinence.~   "
264235|NCT00090532|"~     AG-013,958 is being studied to treat patients with Age-Related Macular Degeneration. A total~     of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55~     years of age with wet age-related macular degeneration.~   "
264236|NCT00090519|"~     The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an~     eye disease called macular edema in patients with diabetes.~   "
264237|NCT00090493|"~     The hope is that the peptide vaccines will stimulate the immune system to attack and kill the~     myeloma cells. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells~     and nothing else.~   "
264238|NCT00090480|"~     This 2-phase study will determine the safety of treating patients with breast cancer with the~     genetically engineered HyperAcute-Breast cancer vaccine. It will establish the proper vaccine~     dose and will examine side effects and potential benefits of the treatment. The vaccine~     contains killed breast cancer cells containing a mouse gene that causes the production of a~     foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response~     to the foreign substance will stimulate the immune system to attack the patient's own cancer~     cells that have similar proteins without this sugar pattern, causing the tumor to remain~     stable or shrink.~      Patients 18 years of age or older with breast cancer that has recurred or no longer responds~     to standard treatment may be eligible for this study. Candidates will be screened with~     medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans.~     MRI, PET, and ultrasound scans may be obtained if needed.~      Participants will receive four vaccinations a month apart from each other. The vaccines will~     be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of~     the study will treat successive groups of patients with increasing numbers of the vaccine~     cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will~     look for any beneficial effects of the vaccine given at the highest dose found to be safe in~     Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In~     addition, patient follow-up visits will be scheduled every 2 months for the first year after~     vaccination and then every 3 months for the next 2 years for the following tests and~     procedures to evaluate treatment response and side effects:~        -  Medical history and physical examination~        -  Blood tests~        -  X-rays and various scans (nuclear medicine/CT/MRI)~        -  FACT-B Assessment questionnaire to measure the impact of treatment on the patient's~          general well-being. The questionnaire is administered before beginning treatment, before~          each vaccination, and during follow-up visits after completing the treatment. It~          includes questions on the severity of breast cancer symptoms and the ability to perform~          normal activities of daily life.~   "
264239|NCT00002659|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if treatment with cisplatin plus epinephrine is effective for head and neck cancer.~      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of~     cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or~     refractory head and neck cancer.~   "
264240|NCT00002631|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not known whether high-dose radiation therapy is more effective than standard dose~     radiation therapy in treating cancer of the esophagus.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     plus high- or standard-dose radiation therapy in treating patients with cancer of the~     esophagus.~   "
264241|NCT00002628|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Peripheral~     stem cell transplantation may be able to replace immune cells that were destroyed by~     chemotherapy used to kill tumor cells, allowing higher doses of chemotherapy to be used.~      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel added to a regimen of~     high-dose chemotherapy with cyclophosphamide and carboplatin followed by peripheral stem cell~     transplantation in treating women with metastatic breast cancer.~   "
264242|NCT00002622|"~     RATIONALE: Talc may relieve malignant pleural effusion. It is not yet known whether wet talc~     is more effective than dry talc in treating patients with malignant pleural effusion.~      PURPOSE: Randomized phase III trial to compare the effectiveness of wet talc with dry talc in~     treating patients with malignant pleural effusion.~   "
264243|NCT00002616|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Peripheral stem cell transplantation combined with biological~     therapy may be an effective treatment for breast cancer.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 with filgrastim to~     stimulate cell production in treating patients with stage IIIB, stage IV, metastatic, or~     recurrent breast cancer who will undergo peripheral stem cell transplantation.~   "
265132|NCT00083889|"~     The purpose of this study is to test whether SU011248 has activity and is safe compared to~     interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).~   "
264244|NCT00002593|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving drugs in different ways may~     kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given in~     different ways in treating patients with surgically removed stage II or stage III colon~     cancer at high risk of recurrence.~   "
264245|NCT00002570|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which treatment regimen is more effective for colorectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of immediate with delayed~     fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without~     signs or symptoms of disease.~   "
264246|NCT00002554|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Monoclonal antibody combined~     with a radioactive substance and given prior to bone marrow transplantation may kill more~     cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given~     prior to bone marrow transplantation in treating patients with acute myelogenous leukemia.~   "
264247|NCT00002527|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of aspirin may be an effective way to prevent~     the recurrence of polyps in colorectal cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating~     patients who have stage I, stage II, or stage III colorectal cancer that has been surgically~     removed.~   "
264248|NCT00002509|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining peripheral stem cell transplantation with combinations of~     drugs may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy~     followed by peripheral stem cell transplantation or autologous bone marrow transplantation in~     women with stage II breast cancer with eight or more positive axillary lymph nodes and in~     women with stage III or metastatic breast cancer.~   "
264249|NCT00090571|"~     Juvenile rheumatoid arthritis (JRA) is the most common chronic inflammatory disease in~     children, and may be related to genetics. Having two siblings who both have JRA in one family~     is rare. The purpose of this registry is to collect patient information and blood samples~     from qualifying JRA siblings and their families. The goal of the registry is to further~     understanding of JRA as related to genetics.~   "
264250|NCT00090467|"~     To investigate biochemical and genetic markers of inflammation and endothelial dysfunction as~     determinants of hypertension.~   "
264251|NCT00090454|"~     To investigate the association of selected genetic markers of inflammation and endothelial~     activation with the occurrence of non-fatal acute myocardial infarction (MI).~   "
264252|NCT00090441|"~     To investigate the role in coronary heart disease (CHD) of intragenic variation in a network~     of six genes affecting lipoprotein transport and metabolism.~   "
264253|NCT00090376|"~     In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is~     being assessed to see if it can help preserve erectile function after prostatectomy.~   "
264254|NCT00090363|"~     This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating~     prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo~     (sugar pill). The study will also provide further information on the safety of ZD4054~     (Zibotentan).~   "
264255|NCT00090324|"~     The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate~     (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.~   "
264256|NCT00090311|"~     The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate~     (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with~     Bipolar I mania.~   "
264257|NCT00090298|"~     A 10-week study to compare the reduction in cholesterol following treatment with two~     different marketed drugs in patients with hypercholesterolemia.~   "
264258|NCT00004915|"~     RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy~     using raloxifene may fight endometrial cancer by reducing the production of estrogen.~      PURPOSE: Phase II trial to study the effectiveness of raloxifene in treating patients who~     have persistent or recurrent endometrial cancer.~   "
264259|NCT00004201|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine plus~     carboplatin with that of gemcitabine plus cisplatin in treating patients who have stage IIIB,~     stage IV, or recurrent non-small cell lung cancer.~   "
264260|NCT00004090|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of gemcitabine and cisplatin in treating~     patients who have metastatic or recurrent solid tumors.~   "
264261|NCT00004029|"~     Phase I trial to study the effectiveness of vaccine therapy in treating patients with~     metastatic prostate cancer. Vaccines may make the body build an immune response to kill tumor~     cells.~   "
264262|NCT00002489|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     children who have non-testicular malignant germ cell tumors.~   "
264263|NCT00002488|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     cyclophosphamide, etoposide, and cisplatin in treating patients with intermediate or~     high-grade non-Hodgkin's lymphoma who have relapsed following or are resistant to~     anthracycline-containing primary combination chemotherapy.~   "
264958|NCT00003720|"~     RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the~     tumor.~      PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have~     AIDS-related Kaposi's sarcoma.~   "
264264|NCT00002487|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Dipyridamole may increase the effectiveness of methotrexate and~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining methotrexate and dipyridamole~     in treating patients with advanced ovarian cancer that is recurrent after or refractory to~     cisplatin-based chemotherapy.~   "
264265|NCT00002471|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkin's lymphoma.~   "
264266|NCT00002458|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating~     children with metastatic neuroblastoma in second remission.~   "
264267|NCT00090558|"~     Regular exercise reduces the risk of heart problems, in part because it improves the work of~     the endothelium (the cells that line blood vessels). Exercise appears to release precursor~     cells from the bone marrow that will later become endothelial cells. A molecule called nitric~     oxide (NO) appears to be involved in this release. However, some heart patients do not~     improve their endothelial function despite regular exercise. The researchers believe that the~     heart disease in these patients may interfere with the normal relationship between exercise~     and endothelial function. This study is designed to test whether giving a patient~     nitroglycerin (which is converted to NO in the bloodstream) will increase the release of~     endothelial precursor cells from the bone marrow. If the study succeeds, it may lead to~     improved healing of arteries in heart disease patients.~      Adults may be eligible for this study if they have coronary artery disease and do not take~     nitroglycerin or nitroglycerin-like medication on a daily basis.~      Volunteers will be admitted to the Clinical Center on 2 separate nights at least 1 week~     apart. On the morning after each admission, volunteers will have blood drawn from an arm vein~     for laboratory tests, and then walk on a treadmill until fatigue or discomfort prevents~     further exercise, or until asked to stop. On one of their admissions, volunteers will receive~     1 tablet of nitroglycerin under the tongue shortly before the treadmill test. Volunteers will~     be monitored by EKGs and blood pressure tests during the treadmill tests, and will have more~     blood drawn at about 15 minutes and 24 hours after each treadmill test. Researchers will~     examine the levels of endothelial precursor cells and nitric oxide in the blood samples taken~     before and after exercise.~   "
264268|NCT00090545|"~     BAY 43-9006 (Sorafenib) is an experimental cancer drug produced by Bayer Health Care~     Corporation. It represents a new class of anticancer agents known as bi-aryl ureas. This~     study will investigate its effect on prostate cancer and its side effects. Researchers expect~     to enroll a maximum of 46 men with prostate cancer for this study. The duration of the study~     will depend on its results.~      Before beginning to take the drug, patients will be admitted to the hospital for 2 days, have~     a medical examination and give blood samples, and have a tumor or bone marrow biopsy. On the~     first day of the study, patients will begin taking the drug as 2 tablets twice daily, morning~     and evening. Blood will be taken throughout the day to determine the drug's level in the~     bloodstream.~      Patients will be discharged from the hospital on the second day, and will continue to take~     the drug twice daily until instructed to stop. During each of the first 4 weeks, patients~     will be required to have their blood pressure checked. At the end of the first 4 weeks,~     patients will have a physical examination and blood tests, as well as a second tumor or bone~     marrow biopsy.~      After the first 4 weeks, patients will continue with their drug regimen. At the end of each~     4-week cycle, patients will have a physical examination and blood tests. Patients will also~     have x-Rays, computed tomography (CT) scans, and/or magnetic resonance imaging (MRIs) at~     every other 4-week examination or as required. Patients will be asked to keep a diary~     recording the time and amount of their medication for this study.~   "
264269|NCT00090506|"~     The purpose of this study is to plan and develop an international collaboration for research~     on the health effects of yoga. This study will also determine the effects of yoga on people~     who are at an increased risk for developing diabetes and people with both HIV and depression.~   "
264270|NCT00090428|"~     This study will determine whether a gluten- and casein-free diet has specific benefits for~     children with autism.~   "
264271|NCT00090415|"~     This study will identify factors that distinguish children with autism from children with~     developmental delay and those with normal development and study the efficacy of intensive~     behavioral therapy in children with autism.~   "
264272|NCT00090285|"~     This study was conducted to demonstrate that Gardasil™ (quadrivalent human papillomavirus~     [qHPV] vaccine) 1) is well tolerated in young men, 2) reduces incidence of external genital~     lesions in young men, 3) reduces the incidence of anal intraepithelial neoplasia (AIN) or~     anal cancer in men having sex with men (MSM), and 4) reduces incidence of Human~     Papillomavirus (HPV) infection in young men. In the 7-month Base Study participants received~     randomly assigned qHPV vaccine or placebo at Day 1, Month 2, and Month 6. Base Study~     follow-up continued through Month 36. In Extension 1 (EXT1), participants who received~     placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine.~     Participants were followed in EXT1 for 7 months. In Extension 2 [LTFU (EXT2)], long-term~     effectiveness, immunogenicity, and safety of qHPV vaccine were followed up to 10 years~     following study enrollment. Participants who received ≥1 dose of qHPV vaccine in the Base~     Study or EXT1 were eligible to enroll in LTFU (EXT2).~   "
264273|NCT00090272|"~     The objective of this study is to evaluate the safety and efficacy of a one time dose of an~     intravenous marketed drug being evaluated for a new indication as compared to a marketed drug~     already approved for the prevention of surgical site infection following colorectal surgery.~   "
264274|NCT00090259|"~     This is a multicenter study to evaluate potential decrease in hospitalization events and time~     between events and increasing longevity in patients with symptomatic congestive heart failure~     and intolerant of first-line medication for heart failure. This study will evaluate if higher~     doses of the investigational drug given daily will be superior to the lower dose of the same~     investigational drug given daily.~   "
268545|NCT00053378|"~     A study to determine the effect of Zemplar on the regulation of serum calcium levels and the~     need for administration of elemental calcium in hypocalcemic intensive care patients~   "
264275|NCT00090246|"~     The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug~     for a new indication in the prevention of postoperative nausea and vomiting in patients~     receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.~   "
264276|NCT00090233|"~     This study was designed to evaluate the safety of the investigational rotavirus vaccine and~     the efficacy to prevent rotavirus gastroenteritis.~   "
264277|NCT00090220|"~     This study was conducted to assess the safety, immunogenicity, efficacy and long-term~     effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV)~     infection and disease in mid-adult women.~   "
264278|NCT00090207|"~     A multicenter trial to assess the safety and efficacy of an investigational drug in the~     prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed~     solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The~     study will evaluate the investigational drug for the treatment of CINV during the first cycle~     of treatment with cisplatin.~   "
264279|NCT00090181|"~     The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic~     low back pain and to investigate the overall safety and tolerability over four weeks of~     treatment.~   "
264280|NCT00090168|"~     A 6-week treatment study to compare the reduction in cholesterol of two drugs~     MK0653A+Simvastatin for high cholesterol, in patients with hypercholesterolemia and~     atherosclerotic or coronary vascular disease.~   "
264281|NCT00090155|"~     The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug~     for a new indication in the prevention of postoperative nausea and vomiting in patients~     receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.~   "
264282|NCT00004026|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. CT-2584 may stop the growth of prostate cancer by stopping blood~     flow to the tumor.~      PURPOSE: Randomized phase II trial to study the effectiveness of CT-2584 in treating patients~     who have metastatic prostate cancer that has not responded to previous therapy.~   "
264283|NCT00004009|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have~     refractory or recurrent acute leukemia or chronic myelogenous leukemia.~   "
264284|NCT00003989|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ISIS 3521 in treating patients who have~     advanced, unresectable, or metastatic non-small cell lung cancer or unresectable or~     metastatic melanoma.~   "
264285|NCT00003962|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 following bone marrow~     transplantation in treating patients who have hematologic cancer at risk of relapse.~   "
264286|NCT00003778|"~     Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have~     recurrent or metastatic soft tissue sarcoma. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die.~   "
264287|NCT00090402|"~     The purpose of this study is to determine the effect of fish oil and the antioxidant alpha~     lipoic acid on factors in the blood that are associated with the progression of Alzheimer's~     Disease (AD).~   "
264288|NCT00090389|"~     The purpose of this study is to evaluate the safety and effectiveness of acupuncture in~     treating women's health conditions.~   "
264289|NCT00090337|"~     RATIONALE: Acupuncture may help relieve pain and dysfunction caused by cancer surgery. It is~     not yet known whether acupuncture is more effective than standard therapy in treating pain~     and dysfunction in patients who have undergone neck surgery for head and neck cancer.~      PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works~     compared to standard therapy in treating pain and dysfunction in patients who have undergone~     neck surgery for head and neck cancer.~   "
264290|NCT00090194|"~     The purpose of this study is to determine if IGIV-C, 10% will be effective in converting a~     donor-recipient crossmatch status from positive to negative. The crossmatch test is used to~     determine if the donor tissue and recipient tissue are compatible. The study will also~     evaluate if IGIV-C, 10% will allow successful kidney transplantation in a patient who~     otherwise would not be able to receive a transplant. Three dose levels of IGIV-C, 10% will be~     evaluated to determine what dose level is most effective.~   "
264291|NCT00090142|"~     The purpose of this study is to determine the effect of an approved medication being studied~     in support of a new approach in the prevention of exercise-induced asthma (a worsening of~     asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have~     a history of worsening asthma after exercise.~   "
264292|NCT00090129|"~     The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a~     first treatment (FT) period followed by either an observation (OB) period and a re-treatment~     (RT) period or an open-label (OL) treatment period, depending on FT period response, and a~     4-week safety follow-up (FU) period. The purpose of this study is to evaluate the safety and~     efficacy of onercept, to be administered as 150 milligram (mg) three times a week, compared~     to matching placebo, for the induction of remission in subjects with moderate to severe~     plaque psoriasis.~   "
264293|NCT00090116|"~     Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to~     chronic release of a brain chemical called glutamate. Glutamate helps transmit messages~     between nerve cells through interaction with a certain type of receptor~     (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of~     excessive glutamate at the receptor (NMDA receptor antagonist).~   "
264294|NCT00090103|"~     This study will investigate the efficacy and safety of treatment with dutasteride and~     tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement~     of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic~     Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits).~     Transrectal ultrasound (TRUS) is done annually.~   "
264295|NCT00090077|"~     To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse~     transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients~   "
264296|NCT00003654|"~     RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph~     nodes, may improve the ability to detect the extent of disease and help plan effective~     surgery for removing breast tumors.~      PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to~     identify the sentinel lymph node under the arm in women with stage I or stage II breast~     cancer.~   "
264297|NCT00003601|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of tretinoin and/or fenretinide may be an~     effective way to prevent the recurrence or further development of dysplastic nevus syndrome.~      PURPOSE: Randomized phase II trial to compare the effectiveness of tretinoin with or without~     fenretinide in treating patients with dysplastic nevus syndrome.~   "
264298|NCT00003588|"~     Phase I trial to study the effectiveness of gene therapy in treating patients with ovarian~     cancer that has not responded to previous treatment. Inserting the p53 gene into a person's~     cancer cells may improve the body's ability to fight cancer or make the cancer cells more~     sensitive to treatment.~   "
264299|NCT00003519|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination~     chemotherapy regimens in treating women with breast cancer who have undergone surgery to~     remove the tumor.~   "
264300|NCT00003406|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel, ifosfamide, and~     carboplatin followed by peripheral stem cell transplantation in treating patients with~     refractory cancer.~   "
264301|NCT00003390|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating~     patients with metastatic kidney cancer.~   "
264302|NCT00003378|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients with previously untreated stage III or stage IV ovarian or primary peritoneal~     cancer.~   "
264303|NCT00003362|"~     RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body~     build an immune response and kill melanoma cells. Combining vaccine therapy with immune~     adjuvants, such as GM-CSF, Montanide ISA-51, or QS21, may be a more effective treatment for~     advanced melanoma.~      PURPOSE: Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide~     vaccine with one of the immune adjuvants GM-CSF, Montanide ISA-51, or QS21 in treating~     patients who have stage III or stage IV melanoma.~   "
264304|NCT00003315|"~     RATIONALE: Drugs like liposomal amphotericin B may be able to relieve fungal infection which~     can be a side effect of chemotherapy. Colony-stimulating factors such as sargramostim may~     increase the number of immune cells found in bone marrow or peripheral blood and may help a~     person's immune system recover from the side effects of chemotherapy. It is not yet known~     whether receiving liposomal amphotericin B plus sargramostim is more effective than receiving~     liposomal amphotericin B alone in treating patients with invasive fungal infection.~      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of liposomal~     amphotericin B with or without sargramostim in treating patients with invasive fungal~     infection.~   "
264305|NCT00003304|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with~     recurrent oligodendroglial tumors following combination chemotherapy.~   "
264306|NCT00090090|"~     To determine the safety and efficacy of elsamitrucin in patients with relapsed or refractory~     non-Hodgkin's lymphoma (NHL). To determine if elsamitrucin is efficacious in a particular~     pathologic NHL subtype(s).~   "
264307|NCT00090064|"~     This study is being conducted to find out if methylenedioxymethamphetamine (MDMA)-assisted~     psychotherapy is safe and can help people with posttraumatic stress disorder (PTSD) arising~     from being a victim of a crime.~   "
264308|NCT00090051|"~     The purpose of this study is to provide treatment for patients who have chronic lymphocytic~     leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide~     (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of~     leukemia symptoms.~   "
264309|NCT00003279|"~     RATIONALE: Vaccines may help the body build an immune response to kill tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of vaccination with~     monoclonal antibody BEC2 and BCG with that of no further therapy in treating patients who~     have limited-stage small cell lung cancer.~   "
264310|NCT00003260|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving the drugs in different~     combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with~     fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil~     and leucovorin in treating recurrent metastatic colorectal cancer~      PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with~     oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent~     metastatic colorectal cancer.~   "
264311|NCT00003237|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug, and giving them after surgery, may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of~     paclitaxel and cisplatin, given after surgery in treating patients with cancer of the~     esophagus or stomach.~   "
264312|NCT00003229|"~     RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the~     body build an immune response and kill the tumor cells.~      PURPOSE: Randomized phase I/II trial to study the effectiveness of vaccine therapy made from~     white blood cells and melanoma cells in treating patients with metastatic melanoma who are~     undergoing surgery for lymph node and tumor removal.~   "
264313|NCT00003224|"~     RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill~     tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with~     either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma.~      PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide~     946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with~     metastatic melanoma that cannot be surgically removed or with melanoma that is likely to~     recur.~   "
264314|NCT00090038|"~     The purpose of this study is to provide treatment for patients who have relapsed~     Non-Hodgkin's lymphoma (NHL) or refractory NHL, and to test the immunity of study subjects~     after receiving four treatments with rituximab.~   "
264315|NCT00003151|"~     RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated~     with gastric lymphoma.~      PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients~     with low grade gastric lymphoma that has not been previously treated.~   "
264316|NCT00003147|"~     Phase I trial to study the effectiveness of gene therapy with the p53 gene in treating~     patients who have cancer of the liver that cannot be surgically removed. Inserting the p53~     gene into a person's tumor may improve the body's ability to fight liver cancer.~   "
264317|NCT00003136|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of amifostine, carboplatin and~     cyclophosphamide, followed by peripheral stem cell transplantation, in treating patients with~     epithelial ovarian cancer or primary peritoneal cancer.~   "
264318|NCT00003131|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating patients with acute~     myeloid leukemia in first relapse.~   "
264319|NCT00002969|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with paclitaxel in~     treating patients with stage IIIB or stage IV non-small cell lung cancer.~   "
264320|NCT00002960|"~     RATIONALE: Giving the p53 gene for ovarian, fallopian tube, or peritoneal cancer may inhibit~     tumor growth. Giving the gene directly into the peritoneum may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of SCH-58500 in treating patients who have~     recurrent or persistent primary ovarian, fallopian tube, or peritoneal cancer.~   "
264321|NCT00002888|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether cisplatin plus fluorouracil are more effective than paclitaxel plus~     cisplatin in treating patients with advanced head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients with advanced head and neck cancer.~   "
264322|NCT00002881|"~     RATIONALE: Hormone therapy may be an effective treatment for prostate cancer.~      PURPOSE: Randomized phase III trial to evaluate the effectiveness of treatment with flutamide~     and suramin with or without hydrocortisone in men who have metastatic or recurrent prostate~     cancer.~   "
264323|NCT00002879|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effects of cladribine in previously treated or untreated~     patients with mantle cell lymphoma.~   "
264324|NCT00002845|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.~      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who~     have metastatic melanoma.~   "
264325|NCT00002783|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving them in different ways may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy before and after surgery~     in treating patients with high-risk stomach cancer.~   "
264326|NCT00002755|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may allow doctors to give~     higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which~     treatment regimen is more effective for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of standard~     cyclophosphamide, methotrexate, and fluorouracil with that of high-dose combination~     chemotherapy plus peripheral stem cell transplantation in treating women who have stage II or~     stage IIIA breast cancer.~   "
264327|NCT00002742|"~     RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in~     patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal~     nystatin is more effective than standard amphotericin B in treating patients with fever and~     neutropenia who are receiving chemotherapy for hematologic cancer or bone marrow~     transplantation for leukemia.~      PURPOSE: Randomized phase III trial to study the effectiveness of liposomal nystatin compared~     with standard amphotericin B to treat fever and neutropenia in patients receiving~     chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.~   "
264328|NCT00002711|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation~     therapy in treating patients with cancer of the esophagus.~   "
264329|NCT00090025|"~     The main purpose of this study is to determine if XL119 is more effective than the~     combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of~     subjects with advanced biliary tumors.~   "
264330|NCT00090012|"~     The purposes of this study are to determine:~        -  The effectiveness of olanzapine as compared to quetiapine in treating and preventing the~          recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in~          patients who are obese or overweight.~        -  The safety of olanzapine as compared to quetiapine.~   "
264332|NCT00089986|"~     The primary objective is to estimate the size of the GR270773 treatment effect on 28-day~     all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected~     or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day~     continuous intravenous infusion.~   "
264333|NCT00005024|"~     RATIONALE: Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in~     patients treated with chemotherapy.~      PURPOSE: Randomized phase III trial to compare the effectiveness of granisetron with that of~     a placebo in preventing nausea and vomiting after chemotherapy in patients who have malignant~     disease.~   "
264334|NCT00004906|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating women who have metastatic breast cancer.~   "
264335|NCT00002674|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Bone marrow transplantation may be able to replace immune cells~     that were destroyed by chemotherapy used to kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     G-CSF and peripheral stem cell transplantation in treating patients with chronic myelogenous~     leukemia.~   "
264336|NCT00002634|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow~     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies can locate tumor~     cells and either kill them or deliver tumor-killing substances to them without harming normal~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, radiation~     therapy, immunotherapy, and bone marrow transplantation in treating patients with~     neuroblastoma.~   "
264337|NCT00002579|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination~     chemotherapy with hormone therapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without tamoxifen in treating women with stage I or stage II breast cancer that can~     be surgically removed.~   "
264338|NCT00002510|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Peripheral stem cell transplantation may allow doctors to give higher doses of~     chemotherapy and radiation therapy and kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of etoposide plus radiation therapy~     followed by peripheral stem cell transplantation in treating patients who have non-Hodgkin's~     lymphoma.~   "
264339|NCT00002499|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II/III trial to study the effectiveness of combination chemotherapy in~     treating children with relapsed acute lymphocytic leukemia.~   "
264340|NCT00002498|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs in different combinations may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of cyclophosphamide,~     methotrexate, and fluorouracil with mitoxantrone in treating older patients with recurrent or~     metastatic breast cancer.~   "
264341|NCT00002493|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known which treatment regimen is more effective for endometrial cancer.~      PURPOSE: Randomized phase III trial to compare radiation therapy with chemotherapy in~     treating patients who have advanced endometrial cancer.~   "
264342|NCT00002479|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of tretinoin in treating patients who have~     any stage mycosis fungoides or Sezary syndrome.~   "
264343|NCT00089973|"~     The purpose of this research study is to find how breast cancer responds to the~     investigational drug, Ispinesib. An investigational drug is a drug that has not been approved~     by the Food and Drug Administration (FDA) and is available for research use only. In~     particular, this study will try is to find the answers to the following research questions:~        1. Does breast cancer respond to Ispinesib?~        2. What are the side effects of Ispinesib?~        3. How much Ispinesib is in the blood at specific times after it is taken?~   "
264344|NCT00089960|"~     This study will determine the safety and effectiveness of AMG 706 in patients with advanced~     GIST.~   "
264345|NCT00089947|"~     This study involves the use of a drug called Thymoglobulin, which is approved in the US to~     treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant~     rejection.~      This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent~     renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin~     as an immunosuppressive agent to help prevent renal transplant rejection.~      Subjects meeting all inclusion and exclusion criteria are eligible to participate in this~     study. In addition to standard treatment, study participants will receive either~     Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for~     at least the first 90 days after transplant. The treatment assignment is random and is not~     chosen by the subject or their physician.~      Subjects will be monitored during treatment with Thymoglobulin and during the transplant~     hospitalization. Additional subject monitoring occurs at Months 1, 3, 6 and 12 following the~     transplant.~      Approximately 150 study subjects from 15-20 transplant centers in the United States will be~     enrolled.~   "
264346|NCT00089921|"~     The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients~     with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic)~     disease-modifying anti-rheumatic drugs (DMARDs).~   "
270558|NCT00048425|"~     The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan~     compared with placebo in the treatment of decompensated chronic heart failure.~   "
264347|NCT00004900|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell~     transplantation in treating women who have metastatic breast cancer.~   "
264348|NCT00004182|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have metastatic or recurrent breast cancer.~   "
264349|NCT00004136|"~     RATIONALE: Heating tumors to several degrees above body temperature may kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of heat therapy in treating patients who~     have unresectable primary or metastatic liver cancer.~   "
264350|NCT00004042|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody F19 in treating~     patients who have advanced or metastatic cancer.~   "
264351|NCT00003974|"~     RATIONALE: Vaccines made from a person's tumor may help the body build an immune response to~     kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have undergone surgery to remove stage I, stage II, or stage IIIA non-small cell lung cancer~     or stage I or stage II mesothelioma.~   "
264352|NCT00089908|"~     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and~     subtropical regions of the world. The purpose of this study is to test the safety of and~     immune response to a new dengue virus vaccine in healthy adults.~   "
264353|NCT00089895|"~     The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients~     with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death,~     heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed~     provisional use of eptifibatide).~   "
264354|NCT00089882|"~     The REVEAL II study provides healthy adult children and siblings of Alzheimer's disease~     patients with genetic testing and information about their own chances of developing the~     disease. The study will compare a condensed education and counseling program to the current~     more extensive program.~   "
264355|NCT00089869|"~     Study of a medication for the treatment of Schizophrenia in patients who are already taking~     Abilify, Risperdal, Seroquel, Zyprexa~   "
264356|NCT00089856|"~     The purpose of this study is to compare the duration of survival between GVAX® immunotherapy~     for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer~     respond to hormone therapy, who have documented metastases, and who have not been treated~     with chemotherapy in the past.~   "
264357|NCT00003951|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have~     metastatic cancer of the pancreas that has not been previously treated or that has not~     responded to previous chemotherapy.~   "
264358|NCT00003897|"~     RATIONALE: Vaccines made from gp100 and sargramostim may make the body build an immune~     response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with gp100 and/or~     sargramostim in treating patients who have malignant melanoma.~   "
264359|NCT00003885|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have recurrent or refractory acute leukemia, chronic myeloid leukemia, myelodysplasia,~     lymphoma, or myeloma.~   "
264360|NCT00003776|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug or combining chemotherapy with surgery~     may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in~     treating patients who have newly diagnosed metastatic osteosarcoma.~   "
264361|NCT00003751|"~     RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the~     tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be~     effective in treating glioblastoma.~      PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and~     radiation therapy in treating patients who have newly diagnosed glioblastoma.~   "
264362|NCT00089843|"~     Women with Anorexia Nervosa have been found to have low bone density. The study will~     determine whether administration of low doses of a natural hormone, testosterone and/or~     risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in~     this condition.~   "
264363|NCT00089830|"~     Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that~     causes a progressive loss of central vision. AMD is the leading cause of legal blindness~     among adults age 50 or older in the Western world. AMD presents in two different types -~     dry and the more severe wet form. Wet AMD is caused by the growth of abnormal blood~     vessels in the macula. Squalamine lactate is an investigational drug that may prevent the~     growth of these abnormal blood vessels. This study will test the safety and efficacy of~     Squalamine in the treatment of AMD.~   "
264364|NCT00089804|"~     The primary purpose of this study is to determine whether abetimus sodium is more effective~     than placebo in delaying time to renal flare in SLE patients with a history of renal disease.~   "
264365|NCT00003709|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of carbendazim in treating patients who~     have advanced solid tumors.~   "
264366|NCT00003686|"~     RATIONALE: Pilocarpine may help to relieve dry mouth in patients receiving opioids for cancer~     therapy. It is not yet known whether pilocarpine is more effective than no further treatment~     for this condition.~      PURPOSE: Randomized phase III trial to determine the effectiveness of pilocarpine in treating~     patients who have dry mouth caused by opioids.~   "
265133|NCT00083876|"~     This study has been designed to evaluate whether combination chemotherapy and~     anti-angiogenesis therapy with thalidomide is equal or superior to autologous~     transplantation for the treatment of multiple myeloma.~   "
264367|NCT00003684|"~     RATIONALE: Theophylline may help to relieve shortness of breath in patients who have cancer.~     It is not yet known whether theophylline is more effective than no further treatment for~     shortness of breath.~      PURPOSE: Randomized phase III trial to determine the effectiveness of theophylline in~     treating shortness of breath in patients who have cancer.~   "
264368|NCT00003626|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with~     metastatic prostate cancer that has not responded to previous hormone therapy.~   "
264369|NCT00003556|"~     Phase I trial to study the effectiveness of vaccine therapy in treating patients with~     melanoma that cannot be treated with surgery. Vaccines may make the body build an immune~     response that may kill tumor cells. Combining more than one vaccine may kill more tumor~     cells.~   "
264370|NCT00089791|"~     This study will evaluate the effectiveness and safety of denosumab in treating women with~     Postmenopausal Osteoporosis.~   "
264371|NCT00089752|"~     The purpose of this study is to determine whether functional status improves in individuals~     with milder obstructive sleep apnea (OSA) following continuous positive airway pressure~     (CPAP) treatment.~   "
264372|NCT00003555|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells~     from the side effects of chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of paclitaxel plus chemoprotection with~     amifostine in treating patients with recurrent or refractory solid tumors.~   "
264373|NCT00003543|"~     RATIONALE: Monoclonal antibodies can find and locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug and combining chemotherapy with monoclonal antibody therapy~     may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus~     combination chemotherapy in treating patients with advanced colorectal cancer.~   "
264374|NCT00003400|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug with peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of high dose chemotherapy plus peripheral~     stem cell transplantation followed by combination chemotherapy in treating patients with~     metastatic prostate cancer that has not responded to hormone therapy.~   "
264375|NCT00003395|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients~     who have advanced hematologic cancer.~   "
264376|NCT00003380|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of~     liposomal doxorubicin and etoposide in treating patients who have recurrent or persistent~     ovarian, fallopian tube, or peritoneal cancer.~   "
264377|NCT00003360|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances,~     such as radioactive iodine, to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in~     treating patients with advanced colorectal cancer.~   "
264378|NCT00003357|"~     RATIONALE: Vaccines made from GM2-KLH and given with QS21 may make the body build an immune~     response to and kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of GM2-KLH vaccine plus QS21 in treating~     patients with breast cancer who have no evidence of disease.~   "
264379|NCT00003348|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of carmustine plus O(6)-benzylguanine in~     treating patients who have recurrent or progressive gliomas of the brain.~   "
264380|NCT00003340|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus topotecan in~     treating patients who have refractory or relapsed acute myelogenous leukemia.~   "
264381|NCT00003312|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     therapy through seeds implanted into the prostate may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of brachytherapy in treating patients with~     stage I or stage II prostate cancer.~   "
264382|NCT00089778|"~     This study will evaluate the safety and side effects of two experimental vaccines in patients~     with kidney cancer and determine whether the vaccines turn on an immune response to the~     cancer. Each vaccine contains one of two peptides (pieces of proteins) from the fibroblast~     growth factor 5 (FGF-5) antigen, a protein produced by some cancer cells, and an oil-based~     liquid called Incomplete Freud's Adjuvant (Montanide ISA-51) that enhances the immune~     response to the vaccine.~      Patients 16 years of age and older who have kidney cancer that has spread beyond the kidney~     or whose primary kidney tumor has been removed within 6 months before entering the study and~     are at high risk for disease recurrence may be eligible for this study. Patients must have~     tissue type human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2) or human~     leukocyte antigen serotype within HLA-A A serotype group (HLA-A3) (determined by a blood test~     for human leukocyte antigen (HLA) typing) and their tumors must produce the FGF-5 peptide.~     Candidates are screened with a physical examination, blood and urine tests, electrocardiogram~     (EKG), tumor biopsy (removal of a small sample of tumor for examination) in patients whose~     tumor is easily accessible, and scans (computed tomography (CT), bone scans) and x-rays if~     current scans are not available.~      Participants are divided into two groups according to their HLA type (HLA-A2 or HLA-A3) to~     receive the vaccine appropriate for their HLA type. They are then further divided into three~     groups: 1) Group 1 includes patients who do not need or are ineligible for treatment with~     interleukin-2 (IL-2), a protein made by certain infection-fighting white cells that helps~     fight tumors) and patients who have previously had IL-2 therapy; 2) Group 2 includes patients~     who require immediate treatment with IL-2; and 3) Group 3 includes patients whose cancer has~     been surgically removed but who are at risk for recurrence.~      Patients in Groups 1 and 3 receive two peptide injections four times a week every 3 weeks for~     up to a year, or until their tumor grows (or returns in patients in Group 3) or the side~     effects are too severe to continue. Tumors are evaluated with a physical examination and~     scans or x-rays every 12 weeks and blood tests are done every 3 weeks. Patients in Group 2~     receive two peptide injections every day for 4 days, along with doses of IL-2 starting the~     day after the first peptide injection. The vaccines are given as injections under the skin of~     the thigh. IL-2 is infused through a vein over 15 minutes every 8 hours for up to 12 doses,~     depending on tolerance. The vaccine and IL-2 are repeated every 10 to 14 days, with tumor~     evaluations every 2 months. Patients stay in the hospital about 1 week during each treatment~     cycle to receive the IL-2.~      All patients undergo leukapheresis, a procedure for collecting large numbers of white blood~     cells. Blood is collected through a needle in an arm vein and flows through a cell separator~     machine, where the white cells are extracted. The rest of the blood is returned to the~     patient through the same needle or a needle in the other arm. The white cells are examined to~     evaluate how the vaccines change the action of immune cells. Some patients may undergo an~     additional biopsy of normal skin and tumor or lymph node to look at the effects of the~     vaccine on the immune cells in the tumor.~      Patients in Group 1 whose cancer grows and patients in Group C whose cancer returns may be~     offered IL-2 treatments as given to Group 2 patients, along with the peptide vaccine. If the~     disease responds to IL-2, the treatment may be repeated after 2 months.~   "
264383|NCT00089765|"~     This study will examine whether he drug ranibizumab can slow or stop the growth of angiomas~     (blood vessel tumors) in patients with Von Hippel-Lindau syndrome (VHL). Angiomas commonly~     develop in the back of the eye on the retina and the optic nerve in patients with VHL.~     Although these tumors are not cancerous, they may cause significant vision loss. Current~     treatments, including laser therapy, cryotherapy, and vitrectomy, may not be successful or~     possible for all patients. Ranibizumab decreases production of VEGF, a growth factor that is~     important for the formation of new blood vessels and that is elevated in patients with VHL.~     Preliminary findings from other studies suggest that ranibizumab can reduce retinal~     thickening caused by vessel and tumor growth and improve vision.~      Patients 18 years of age and older with retinal angiomas due to VHL in one or both eyes and~     central vision loss of 20/40 or worse may be eligible for this study. Participants undergo~     the following tests and procedures:~        -  Medical history, physical examination, electrocardiogram (EKG) and blood tests.~        -  Eye examination, including eye pressure measurement and dilation of the pupils to~          examine the retina.~        -  Fluorescein angiography to evaluate the eye's blood vessels. For this test, a yellow dye~          is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of~          the retina are taken using a camera that flashes a blue light into the eye. The pictures~          show if any dye has leaked from the vessels into the retina, indicating possible blood~          vessel abnormality.~        -  Optical coherence tomography to measure retinal thickness. The eyes are examined through~          a machine that produces cross-sectional pictures of the retina. These measures are~          repeated during the study to determine changes, if any, in retinal thickening.~        -  Stereoscopic color fundus photography to examine the back of the eye. The pupils are~          dilated with eye drops to examine and photograph the back of the eye.~        -  Electroretinogram (ERG) to measure electrical responses generated from within the~          retina. For this test, the patient sits in a dark room for 30 minutes with his or her~          eyes patched. Then, a small silver disk electrode is taped to the forehead, the eye~          patches are removed, the surface of the eye is numbed with eye drops, and contact lenses~          are placed on the eyes. The patient looks inside an open white globe that emits a series~          of light flashes for about 20 minutes. The contact lenses sense small electrical signals~          generated by the retina when the light flashes.~        -  Ranibizumab injections to treat ocular angiomas. Ranibizumab is injected through a~          needle into the eye's vitreous (gel-like substance that fills the inside of the eye).~          Seven injections are given over a 28-week period. Before each injection, the surface of~          the eye is numbed with anesthetic eye drops. This is followed by injection of another~          anesthetic into the lower portion of the eye in the clear tissue surrounding the white~          of the eye. After a few minutes, the ranibizumab is injected into the vitreous. Patients~          receive ranibizumab injections at the first visit (during enrollment) and again at 4, 8,~          12, 16, 20 and 24 weeks after the first injection. At the 28-week visit, the doctor will~          determine if further treatment is needed. Patients can continue to have injections every~          4 weeks until 1 year of follow-up (54 weeks).~      At each injection visit, participants repeat most of the tests described above to evaluate~     the response to treatment and return a week later for another eye examination.~   "
264384|NCT00003294|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells~     from the side effects of chemotherapy. Colony-stimulating factors such as filgrastim may~     increase the number of immune cells found in bone marrow or peripheral blood and may help a~     person's immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of~     paclitaxel plus carboplatin given with amifostine and filgrastim in treating patients with~     recurrent or metastatic cancer.~   "
264385|NCT00003284|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy~     followed by peripheral stem cell transplantation in treating patients with lung cancer.~   "
264398|NCT00003044|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs in different ways may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cisplatin and epinephrine administered~     directly into the tumor in treating patients who have primary liver cancer that cannot be~     removed during surgery.~   "
264386|NCT00003251|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as~     amifostine, may protect normal cells from the side effects of chemotherapy and radiation~     therapy.~      PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin,~     paclitaxel, and radiation therapy in treating patients who have advanced unresectable head~     and neck cancer.~   "
264387|NCT00003220|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with~     metastatic colorectal cancer.~   "
264388|NCT00003200|"~     The purpose of this research study is to develop a new chemo radiotherapy regimen for the~     treatment of cancer of the head and neck for patients who have received induction~     chemotherapy; and to determine the highest dose of Taxotere which can be safely given~     together with radiotherapy.~   "
264389|NCT00089739|"~     This study will try to identify markers of immune activity in uveitis patients that correlate~     with the state of disease activity. Uveitis is a group of inflammatory eye diseases that can~     cause vision loss. The study will examine whether certain substances in the blood can predict~     a reactivation of disease before it occurs, and how therapy may influence the activity of~     these substances. Previous studies have found some possible markers called GITR~     (glucocorticoid induced TNF related family receptor), SOCS (suppressors of cytokine~     secretion), and interleukin-15. Markers such as these may help guide physicians in safely~     tapering medicines in uveitis patients.~      Patients 18 years of age and older with sight-threatening uveitis may be eligible for this~     study. Participants are slowly tapered off their medicines when their disease is stable and~     there is no evidence of significant inflammation. If the disease remains inactive during~     tapering, all drug therapy is eventually stopped. Patients have eye examinations about every~     1 to 3 months when the disease is quiet and every 2 to 4 weeks during flare-ups. Blood~     samples are drawn 2 to 3 times a year. In addition, patients may have the following~     procedures if needed:~        -  Eye photography: Eye drops are given to enlarge the pupils for a thorough eye~          examination, and a special camera is used to take photographs.~        -  Fluorescein angiography: This test checks for abnormalities of eye blood vessels. A~          yellow dye is injected into an arm vein and travels to the blood vessels in the eyes.~          Pictures of the retina are taken with a special camera that flashes a blue light into~          the eye. The pictures show if any dye has leaked from the vessels into the retina,~          indicating possible abnormalities.~   "
264390|NCT00089726|"~     The main purpose of this research study is to determine if a vaccine made from a patient's~     lung cancer tumor cells will be effective in making the cancer shrink or disappear. The~     vaccine will be given by itself to some patients, while other patients will get the vaccine~     with cyclophosphamide (a type of chemotherapy). Studies in animals and other cancer vaccine~     trials suggest that cyclophosphamide may make tumor vaccines more potent. This study will try~     to determine if vaccine given with or without this chemotherapy is effective in destroying~     lung cancer cells. Additionally, the study will collect information on vaccine safety, both~     with and without chemotherapy, and whether the vaccine improves lung cancer-related symptoms~     (e.g., shortness of breath).~      Tumors from surgical resection will be processed and made into a vaccine. Prior to treatment,~     patients will be randomized equally to one of two treatment groups, Cohort A and Cohort B.~     Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will~     be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day~     prior to the first, third, and fifth vaccine treatments. Patients will receive intradermal~     (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of~     up to five vaccine treatments. The duration of this study, including active follow up, is~     approximately two years. After this, patients will be followed-up yearly for a total of 15~     years.~   "
264391|NCT00089713|"~     This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week~     double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide~     treatment phase. The combined total duration of patient participation is approximately 17-20~     weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the~     study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).~   "
264392|NCT00089700|"~     This is a 48-week study to compare TNX-355 plus OBT to placebo plus OBT in HIV subjects. You~     must have a stable viral load of at least 10,000 copies/ml, been treated with highly active~     antiretroviral therapy (HAART) for at least 6 months, be triple class experienced, and~     presently failing or have failed a HAART regimen. Subjects will receive infusions every week~     for 8 weeks, then every two weeks.~   "
264393|NCT00003197|"~     RATIONALE: Green tea extract contains ingredients that may slow the growth of certain~     cancers, as well as prevent the development of new cancers.~      PURPOSE: Phase I trial to study the effectiveness of green tea extract in treating patients~     with advanced solid tumors that are refractory to standard therapy.~   "
264394|NCT00003123|"~     RATIONALE: Amifostine may be effective in helping blood counts return to normal in treating~     patients with myelodysplastic syndrome.~      PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with~     advanced myelodysplastic syndrome.~   "
264395|NCT00003115|"~     RATIONALE: Giving hydromorphone in different ways may relieve the pain associated with cancer~     surgery.~      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of epidural~     hydromorphone with hydromorphone infusion in patients with prostate cancer undergoing radical~     prostatectomy.~   "
264396|NCT00003102|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in~     treating patients with advanced kidney cancer.~   "
264397|NCT00003058|"~     Troglitazone may help liposarcoma cells develop into normal cells. This was a single arm,~     open-label study with a two-stage design to evaluate troglitazone in patients with~     liposarcoma stratified by histologic subtype.~   "
264419|NCT00089583|"~     This is a 48-week study to collect information on the safety and activity of an~     investigational medicine in patients, ages 2 to 18 years old, with HIV infection .~   "
275370|NCT00000284|"~     The purpose of this study is to determine the effects of cotinine with or without a~     transdermal nicotine replacement on tobacco withdrawal symptoms.~   "
264399|NCT00003025|"~     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune~     response to and kill tumor cells. Combining vaccine therapy with surgery may be an effective~     treatment for pancreatic cancer.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients~     with stage I or stage II pancreatic cancer that has been surgically removed.~   "
264400|NCT00003003|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining~     mitomycin with a chemotherapy drug may reduce resistance to the drug and allow the cancer~     cells to be killed.~      PURPOSE: Phase I trial to study the effectiveness of mitomycin and mitoxantrone in treating~     patients with acute myelogenous leukemia and to determine whether mitomycin can reduce the~     cancer's resistance to chemotherapy.~   "
264401|NCT00002955|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with advanced cancer of the pancreas.~   "
264402|NCT00002933|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have metastatic or recurrent colorectal cancer.~   "
264403|NCT00089687|"~     The purpose of this study is to assess GBR 12909 in cocaine experienced African American~     Volunteers.~   "
264404|NCT00089674|"~     This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing~     Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.~   "
264405|NCT00089661|"~     The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects~     undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.~   "
264406|NCT00089648|"~     The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in~     patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab~     (Avastin) -based treatment.~   "
264407|NCT00089635|"~     The purpose of this study is to determine that ABX-EGF (panitumumab) will have clinically~     meaningful anti-tumor activity in patients with metastatic colorectal cancer who have~     developed progressive disease or relapsed while on or after prior fluoropyrimidine,~     irinotecan and oxaliplatin chemotherapy.~   "
264408|NCT00002914|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of piritrexim in treating patients with~     advanced cancer of the urinary tract that has not responded to previous treatment.~   "
264409|NCT00002909|"~     Phase I trial to study the effectivenes of phenylbutyrate in treating adults with refractory~     solid tumor or lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die.~   "
264410|NCT00002890|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in~     treating patients with myelodysplastic syndrome or relapsed or refractory acute myeloid~     leukemia or chronic myelogenous leukemia.~   "
264411|NCT00002865|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of high-intensity, brief-duration~     chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia.~   "
264412|NCT00002749|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of carboplatin in patients with~     progressive glioma.~   "
264413|NCT00002655|"~     RATIONALE: Cryosurgery kills cancer cells by freezing them during surgery.~      PURPOSE: Phase I/II trial to study the effectiveness of cryosurgery in treating patients with~     unresectable primary liver cancer or liver metastases.~   "
264414|NCT00002635|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients~     with advanced cutaneous T-cell lymphoma.~   "
264415|NCT00002619|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Bone marrow or peripheral stem cell transplantation may be able to~     replace immune cells that were destroyed by chemotherapy used to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous~     bone marrow or peripheral stem cell transplantation in treating patients with glioblastoma~     multiforme or brain stem tumors.~   "
264416|NCT00002609|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     tumor-killing substances to them, without harming normal cells. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die. Combining~     chemotherapy with monoclonal antibody therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus monoclonal antibody~     therapy in treating patients with acute promyelocytic leukemia in remission.~   "
264417|NCT00002585|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating women with~     metastatic breast cancer.~   "
264418|NCT00089596|"~     This study hopes to show that specially treated umbilical cord cells, called stem cells, can~     be safely given to a person after they receive chemoradiation therapy or chemotherapy for~     their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells~     that are needed to make the different types of cells in their blood, including their immune~     system cells. These cells must be replaced in order for the blood and immune systems to work~     properly. Some people receive bone marrow transplants or other types of stem cell transplants~     to get the cells they need. CB001 is being developed as an option for people who need bone~     marrow transplants or other types of transplants to replace those cells. It is also being~     developed for people who do not have the option of other types of transplants.~   "
264420|NCT00005626|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have newly diagnosed or relapsed non-Hodgkin's lymphoma or leukemia.~   "
264421|NCT00005607|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have metastatic or recurrent cancer of the stomach or esophagus.~   "
264422|NCT00002574|"~     Phase II trial to study the effectiveness of homoharringtonine and interferon alfa in~     treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy use different~     ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may~     interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may~     kill more cancer cells.~   "
264423|NCT00002562|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with~     advanced, refractory, or recurrent cervical or vaginal cancer.~   "
264424|NCT00002507|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether combining mitomycin or porfiromycin with radiation therapy~     is more effective in treating patients with head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus~     either mitomycin or porfiromycin in treating patients with head and neck cancer.~   "
264425|NCT00089622|"~     This study will evaluate the effectiveness of a skin patch formulation of the dopamine~     agonist Lisuride in controlling parkinsonian symptoms and dyskinesias (involuntary movements)~     caused by levodopa. Lisuride is currently available in tablet form; this study will test~     whether a patch formulation that provides continuous stimulation of the dopamine receptors~     will better control disease symptoms.~      Patients between 40 and 80 years old with Parkinson's disease and dyskinesias may be eligible~     for this 4-month study. Participants undergo the following procedures:~      Screening and baseline evaluation: Participants are evaluated with a medical history,~     physical examination, neurologic evaluation, blood tests, urinalysis, and electrocardiogram.~     A chest X-ray and MRI or CT scan of the brain are done, if needed. If possible, patients stop~     taking all antiparkinsonian medications except levodopa (Sinemet) for 1 month (2 months for~     Selegiline) before the study begins and throughout its duration.~      Dose-finding phase: Patients are admitted to the NIH Clinical Center for 2 to 3 days for a~     levodopa dose-finding procedure. For this test, patients stop taking Sinemet and instead~     have levodopa infused through a vein. During the infusions, the drug dose is increased slowly~     until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study~     dose is reached. Symptoms are monitored frequently. (Patients who have had dosing infusions~     in the last 3 months do not have to undergo this phase of the study.)~      Active study phase: Patients are randomly assigned to one of two treatment groups. One group~     receives a placebo (a patch with no active drug) and a patch that contains Lisuride; the~     other group receives placebo throughout the entire study. Patients are instructed on how to~     apply the patches. During the first 2 weeks of this study phase, the number of patches~     containing active drug is gradually increased until the individual's optimum dose is reached.~     Patches are changed about every 2 days. During this time, intake of other antiparkinsonian~     medications is tapered down and patients are evaluated frequently. For the next 3 months,~     patients wear the patches continuously at the optimum dose. The patches are changed every 2~     days or once a week, depending on the individual patient's need. Two levodopa infusion~     studies are done in the active study phase as they were in the dose-finding phase - at the~     beginning of the dose escalation phase and again at the end of the dose maintenance phase. In~     addition, patients are tested for their ability to perform different motor tasks.~      Sleep studies: Because oral Lisuride can cause excessive sleepiness, some patients are asked~     to participate in a sleep study to evaluate sleep patterns during the night and daytime~     sleepiness. The subject's brain, muscles, and breathing are continuously monitored during~     sleep. Also, an electroencephalogram (EEG) is done to record brain waves while the subject~     lies quietly, breathes deeply, watches flashes of light, sleeps, or performs a task.~      Safety checks: Patients are monitored closely for safety with a history of side effects,~     blood tests, and ECG each time a new supply of study drug is dispensed.~      Follow-up: 2 weeks after completing the active phase of the study, patients are contacted by~     phone for a follow-up evaluation.~   "
264426|NCT00089609|"~     This is a Phase II study of docetaxel, bevacizumab, prednisone and thalidomide in patients~     with androgen independent metastatic prostate cancer who are previously untreated with~     chemotherapy. The primary objective of this study is to determine if the combination of~     docetaxel, thalidomide and bevacizumab is able to be associated with a sufficiently high~     proportion of patients with a prostate-specific antigen (PSA) response to be worthy of~     further investigation in metastatic prostate cancer. We will also be looking at multiple~     secondary endpoints. These will include possible pharmacokinetic interactions among the study~     agents, potential correlation between patient genotype and efficacy of treatment. We will~     also be looking for circulating tumor cells in blood before and after treatment. Additionally~     we will be monitoring the tolerability of the regimen and survival duration as endpoints as~     well. We hope to use this trial to build on the promising results seen in our~     thalidomide/docetaxel protocol where there was a significant PSA decline and a trend toward~     survival benefit.~   "
264427|NCT00089570|"~     The purpose of this study is to determine whether terlipressin is safe and effective in the~     treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.~   "
264428|NCT00089557|"~     This study is an open-label, multicenter, extension study for subjects who completed~     NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks~     (up to +7days) before entry into Study C114~   "
264429|NCT00089544|"~     Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor.~     Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy,~     such as doxorubicin, ifosfamide, and dacarbazine, work in different ways to stop tumor cells~     from dividing so they stop growing or die. Giving thalidomide together with radiation therapy~     and/or chemotherapy before surgery may shrink the tumor so that it can be removed. This phase~     II trial is studying how well giving preoperative (before surgery) thalidomide together with~     radiation therapy works in treating patients with low-grade primary soft tissue sarcoma, and~     how well giving thalidomide together with radiation therapy, doxorubicin, ifosfamide, and~     dacarbazine works in treating patients with high-grade or intermediate-grade primary soft~     tissue sarcoma of the arm, leg, chest wall, or abdominal wall.~   "
264430|NCT00005591|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cell from dividing so they stop growing or die.~     Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cetuximab plus gemcitabine in treating~     patients who have locally advanced, metastatic, or recurrent cancer of the pancreas.~   "
264431|NCT00005076|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die.~      PURPOSE: Phase II trial to study the effectiveness of cetuximab and irinotecan in treating~     patients who have advanced colorectal cancer that has not responded to previous treatment.~   "
264432|NCT00005070|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have~     stage IVB or recurrent cervical cancer.~   "
264433|NCT00005057|"~     RATIONALE: Inserting a modified herpesvirus gene into a person's melanoma cells may make the~     cancer more sensitive to the antiviral agent ganciclovir.~      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who~     have stage IV melanoma.~   "
264434|NCT00005056|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who~     have progressive kidney cancer~   "
264435|NCT00004937|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating~     patients who have recurrent glioblastoma multiforme.~   "
264436|NCT00004219|"~     RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients~     treated with radiation therapy. It is not yet known whether lerisetron is more effective than~     granisetron in preventing nausea and vomiting.~      PURPOSE: Randomized phase III trial to compare the effectiveness of lerisetron with that of~     granisetron in preventing nausea and vomiting in men who are being treated with radiation~     therapy for stage I seminoma.~   "
264437|NCT00004215|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Colony-stimulating factors such as leridistim and filgrastim~     increase the number of immune cells found in bone marrow or peripheral blood and may help a~     person's immune system recover from the side effects of chemotherapy.~      PURPOSE: Randomized phase II trial to compare the effectiveness of leridistim with that of~     filgrastim to reduce side effects in older patients who are receiving cytarabine and~     daunorubicin for acute myeloid leukemia.~   "
264438|NCT00004207|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of liposomal daunorubicin in treating~     patients who have metastatic breast cancer.~   "
264439|NCT00089531|"~     This study will evaluate whether an experimental vaccine intended to prevent HIV infection is~     safe and whether it causes any side effects. It will also examine whether the vaccine, called~     VRC-HIVDNA016-00-VP, causes an immune response, and will monitor participants for the social~     impact of being in an HIV vaccine study. VRC-HIVDNA016-00-VP contains synthetic DNA that~     codes for parts of four HIV proteins. It also contains a promoter piece of DNA that is~     needed to start protein production. The promoter DNA is also synthetic and is like the~     promoter in another virus called cytomegalovirus (CMV). The vaccine contains no live HIV~     virus or CMV and cannot cause either of these illnesses.~      Healthy volunteers between 18 and 44 years old who are HIV-negative may be eligible for this~     32-week study. Candidates are screened with a medical history, physical examination, and~     blood and urine tests.~      Participants receive three injections of the experimental vaccine approximately 28 days~     apart. The injections are given with a system called the Biojector 2000 that delivers the~     vaccine through the skin into the muscle without the use of a needle. Subjects are observed~     for side effects for at least 30 minutes after each vaccination and are required to telephone~     the clinic staff 1 to 2 days after the injection to report how they are doing. In addition,~     they are given a diary card to take home, on which they record their temperature and any~     symptoms daily for five days.~      Participants return to the clinic two weeks after each injection. They return the completed~     diary card and are checked for any health changes or problems since the last visit. They are~     asked how they are feeling and what medications, if any, they have taken. Blood and urine~     samples are collected. Some subjects may be asked to have laboratory tests between regular~     visits if needed to evaluate a change in health. Participants are also asked about any social~     effects they may have experienced as a result of their participation in the study.~   "
264440|NCT00089518|"~     The angiotensin receptor blocker (ARB) valsartan is a drug commonly used to treat high blood~     pressure. Valsartan may also help slow down the progression of kidney disease in HIV infected~     people. The purpose of this study is to compare valsartan and antiretroviral therapy (ART) to~     ART alone in slowing kidney disease progression in people with HIV.~   "
264441|NCT00089505|"~     Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV~     drug regimens. However, HIV infected women who have previously taken the single dose NNRTI~     nevirapine (SD NVP) for the prevention of mother-to-child transmission (MTCT) of HIV may not~     respond as well to NNRTIs as women who have never taken NVP. Another class of anti-HIV drugs,~     protease inhibitors (PIs), may be more effective for women who have previously taken NNRTIs.~     This study will compare the effectiveness of NNRTI- and PI-based regimens in women who have~     taken NVP for prevention of MTCT of HIV. This study will also compare regimens including an~     NNRTI with regimens including a PI in women who have never taken NVP.~   "
264442|NCT00089492|"~     This study will assess the safety and efficacy of once-daily administration of Fuzeon~     compared with twice-daily administration in HIV-1 infected patients who have received prior~     treatment. Patients will also receive an optimized treatment consisting of antiretroviral~     (ARV) therapy as determined by the treating physician. The anticipated time on study~     treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
264443|NCT00089479|"~     This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere~     alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer.~     Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either~     1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle~     or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study~     treatment is until disease progression, and the target sample size is 500+ individuals.~   "
264444|NCT00089466|"~     New treatment options are critical for treatment-experienced HIV infected patients with drug~     resistance. HIV entry inhibitors have been shown effective in patients with resistance to~     other anti-HIV drugs. This study will test the safety and anti-HIV activity of eight~     different doses of the HIV entry inhibitor AMD11070 (also known as AMD070) in HIV infected~     patients.~   "
264445|NCT00089453|"~     The purpose of this study is to induce anti-myeloma responses in patients with high risk or~     relapsed myeloma using combination chemo- and immunotherapy comprising sequentially: 1)~     lymphoid and myeloid suppressive conditioning, 2) adoptive transfer of purified KIR-ligand~     mismatched Natural Killer cells from a haplo-identical donor, and 3) autografting two weeks~     after infusion of NK cells to ensure autologous reconstitution. Other objectives include~     establishing the response rate, disease free survival, progression free survival and toxicity~     of regimen. Secondary objectives are to monitor the persistence of haplo-identical purified~     KIR-ligand mismatched Natural Killer cells by molecular methods, select haplo-identical~     purified KIR-ligand mismatched donors and predict prior to therapy which donor will induce a~     response, monitor Natural Killer cell reconstitution prior to and after autografting, and~     establish Natural Killer cell clones after autografting and determine origin and specificity.~   "
264446|NCT00089440|"~     The purpose of this study is to assess the interactions between intravenous methamphetamine~     and aripiprazole.~   "
264447|NCT00089427|"~     This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine~     the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced~     Delivery (CED) to the area around the tumor site after the tumor is surgically removed~     (resection). In addition, the patient will receive radiation therapy and may or may not be~     treated with oral temozolomide.~   "
264459|NCT00089245|"~     The purpose of this study is to find a safe dose of a new medicine called antibody 8H9.~     Antibodies are made by the body to fight infections and in some cases, to fight tumors. The~     antibody 8H9 is made by mice and can attack many kinds of tumors. 8H9 antibody can have a~     dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to~     patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the~     spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation~     targeted therapies.~   "
264460|NCT00089219|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and~     comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or~     stage IV melanoma.~   "
264448|NCT00089414|"~     This study will determine whether uninterrupted treatment with birth control pills over~     several menstrual cycles prevents severe premenstrual syndrome (PMDD).~      Previous studies have shown that the hormones estrogen and progesterone regulate mood in~     women with MRMD. This study will use various treatment regimens with birth control pills and~     placebo (sugar pill) to clarify the relationships among estrogen and progesterone, the~     menstrual cycle, and mood.~      Healthy women between 18 and 45 years of age who menstruate may be eligible for this 15-week~     study. Candidates are screened with a physical examination, blood and urine tests, an~     electrocardiogram, and 3 months of symptoms ratings to confirm MRMD.~      Participants are randomly assigned to one of three treatment groups. Group 1 takes a birth~     control pill every day and on three occasions takes a placebo capsule. Group 2 takes a birth~     control pill most but not all days and on three occasions takes a placebo capsule. Group 3~     takes a birth control pill every day and on three occasions takes another medication called~     CDB-2914 that causes menstrual bleeding to occur.~      Participants come to the NIH clinic every other week for blood tests and measurement of vital~     signs (blood pressure, pulse, and temperature) and to complete symptoms ratings scales.~     Subjects who develop breakthrough bleeding (menstruation earlier than expected) will have a~     transvaginal ultrasound. For this procedure, a probe is inserted into the vagina for about 10~     minutes. The probe gives off and receives sound waves that can be used to form a picture of~     the endometrium (lining of the uterus).~   "
264449|NCT00089401|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different~     ways may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan~     works in treating patients with unresectable colorectal cancer that has metastasized to the~     liver.~   "
264450|NCT00089388|"~     This randomized phase II trial is studying how well cilengitide works in treating patients~     with acute myeloid leukemia. Cilengitide may stop the growth of cancer cells by blocking the~     enzymes necessary for their growth~   "
264451|NCT00089362|"~     This phase I trial is studying the side effects and best dose of alvespimycin hydrochloride~     in treating patients with metastatic or unresectable solid tumors. Drugs used in~     chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop tumor cells~     from dividing so they stop growing or die.~   "
264452|NCT00089349|"~     This phase II trial is studying how well giving alemtuzumab with or without methotrexate and~     mercaptopurine works in treating young patients with relapsed acute lymphoblastic leukemia.~     Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or~     deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy, such as methotrexate and mercaptopurine, work in different ways to stop cancer~     cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with~     chemotherapy may kill more cancer cells.~   "
264453|NCT00089323|"~     RATIONALE: Diagnostic procedures that detect tumor cells in the bone marrow may help doctors~     predict disease recurrence and plan more effective treatment.~      PURPOSE: This clinical trial is studying how well diagnostic procedures work in detecting~     tumor cells in the bone marrow of patients who have undergone surgery for stage I, stage II,~     or stage IIIA breast cancer.~   "
264454|NCT00089310|"~     RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may improve the ability~     to detect cancer that has spread to the lymph nodes.~      PURPOSE: This clinical trial is studying how well sentinel lymph node mapping works in~     detecting cancer that has spread to the lymph nodes in patients who are undergoing surgery~     for stage I non-small cell lung cancer.~   "
264455|NCT00089297|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as~     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to damage tumor cells. Giving cetuximab with combination chemotherapy and radiation~     therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that~     needs to be removed. Giving cetuximab after surgery may kill any tumor cells that remain.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination~     chemotherapy and radiation therapy works in treating patients who are undergoing surgery for~     stage III or stage IV head and neck cancer.~   "
264456|NCT00089284|"~     Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate~     cancer cells and either kill them or deliver radioactive cancer-killing substances to them~     without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium~     Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug.~      This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when~     administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they~     work in treating patients with stage II, stage III, or stage IV relapsed or refractory~     non-Hodgkin's lymphoma.~   "
264457|NCT00089271|"~     This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients~     with metastatic or unresectable solid tumors or lymphomas. Drugs used in chemotherapy, such~     as 17-DMAG, work in different ways to stop cancer cells from dividing so they stop growing or~     die~   "
264458|NCT00089258|"~     RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells.~     Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal~     antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining~     different types of biological therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving beta-glucan, isotretinoin, and~     sargramostim together with monoclonal antibody 3F8 works in treating patients with~     neuroblastoma that has not responded to previous treatment.~   "
264461|NCT00089206|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients~     with stage III or stage IV melanoma that cannot be removed by surgery.~   "
266191|NCT00015990|"~     Phase II trial to study the effectiveness of thalidomide in treating patients who have~     myelodysplastic syndrome. Thalidomide may improve the immune system's ability to fight~     myelodysplastic syndrome~   "
264462|NCT00089193|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Colony-stimulating factors such as sargramostim may increase the number of immune cells found~     in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a~     stronger immune response and kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying vaccine therapy and sargramostim to see~     how well they work compared to vaccine therapy alone in treating patients with stage II B,~     stage IIC, stage III, or stage IV melanoma.~   "
264463|NCT00089180|"~     This randomized phase II trial is studying how well T4N5 liposomal lotion works in preventing~     the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant.~     Chemoprevention therapy is the use of certain drugs to try to prevent the development of or~     recurrence of cancer. T4N5 liposomal lotion may be effective preventing the recurrence of~     nonmelanoma skin cancer in patients who have undergone a kidney transplant.~   "
264464|NCT00089167|"~     RATIONALE: Drugs such as melphalan, thalidomide, and dexamethasone may be effective in~     treating patients with primary systemic amyloidosis.~      PURPOSE: This phase II trial is studying how well giving melphalan together with thalidomide~     and dexamethasone works in treating patients with primary systemic amyloidosis.~   "
264465|NCT00089154|"~     This phase II trial is studying how well apolizumab works in treating patients with chronic~     lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab~     can locate cancer cells and either kill them or deliver cancer-killing substances to them~     without harming normal cells.~   "
264466|NCT00089141|"~     RATIONALE: Mycophenolate mofetil added to immunosuppressive treatment regimens may be~     effective in treating newly diagnosed chronic graft-versus-host disease caused by stem cell~     transplantation. It is not yet known whether immunosuppressive treatment regimens are more~     effective with or without mycophenolate mofetil in treating chronic graft-versus-host~     disease.~      PURPOSE: This randomized phase III trial is studying whether the addition of mycophenolate~     mofetil improves the efficacy of immunosuppressive treatment regimens in patients with newly~     diagnosed chronic graft-versus-host disease.~   "
264467|NCT00089128|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one~     drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan~     works in treating patients with locally advanced or metastatic bladder cancer.~   "
264468|NCT00089115|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Vaccines made~     from a person's cancer cells may make the body build an immune response to kill cancer cells.~     Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone~     marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with~     vaccine therapy may cause a stronger immune response and kill more cancer cells.~      PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together~     with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating~     patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.~   "
264469|NCT00089102|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one~     drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan~     works in treating patients with locally advanced unresectable or metastatic kidney cancer.~   "
264470|NCT00089089|"~     This phase I trial is studying the side effects and best dose of decitabine in treating~     patients with metastatic or unresectable refractory solid tumors or lymphomas. Drugs used in~     chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing~     so they stop growing or die~   "
264471|NCT00089076|"~     Biological therapies, such as MDX-010, work in different ways to stimulate the immune system~     and stop cancer cells from growing. This phase I/II trial is studying the side effects and~     best dose of MDX-010 and to see how well it works in treating patients with recurrent or~     refractory B-cell non-Hodgkin's lymphoma.~   "
264472|NCT00089063|"~     This randomized phase II trial is studying vaccine therapy and sargramostim to see how well~     they work compared to vaccine therapy alone in treating patients who have undergone surgery~     for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may~     make the body build an immune response to kill tumor cells. Colony-stimulating factors such~     as sargramostim increase the number of immune cells found in bone marrow or peripheral blood.~     Combining vaccine therapy with sargramostim may make a stronger immune response.~   "
264473|NCT00089050|"~     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells~     more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more~     cancer cells.~      PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with~     cyclosporine works in treating older patients with relapsed acute myeloid leukemia.~   "
264474|NCT00089037|"~     RATIONALE: Sirolimus, tacrolimus, and methotrexate may be effective in preventing acute~     graft-versus-host disease in patients who are undergoing donor stem cell transplantation.~      PURPOSE: This phase I/II trial is studying the side effects of sirolimus when given together~     with tacrolimus and methotrexate and to see how well they work in preventing acute~     graft-versus-host disease in patients who are undergoing donor stem cell transplantation for~     hematologic cancer.~   "
264475|NCT00089024|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink~     the tumor so that it can be removed.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with radiation therapy works in treating patients who may undergo surgery for locally~     advanced pancreatic cancer.~   "
264548|NCT00003090|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill non-small cell~     lung cancer cells.~      PURPOSE: Phase II trial to study the effect of biological therapy with interleukin-2 in~     patients with previously treated non-small cell lung cancer.~   "
264476|NCT00089011|"~     This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing~     graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or~     without fludarabine phosphate followed by donor peripheral blood stem cell transplant for~     hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI~     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.~     It also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune system and help destroy any remaining cancer~     cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also~     make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate~     mofetil after the transplant may stop this from happening.~   "
264477|NCT00088998|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies~     such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing~     substances to them without harming normal cells. Bevacizumab may also stop the growth of~     tumor cells by stopping blood flow to the tumor. Combining chemotherapy with monoclonal~     antibody therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel and capecitabine together~     with bevacizumab works in treating patients with metastatic breast cancer.~   "
264478|NCT00088985|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing~     so they stop growing or die. Combining vaccine therapy with monoclonal antibody therapy and~     chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with~     trastuzumab and vinorelbine works in treating women with locally recurrent or metastatic~     breast cancer.~   "
264479|NCT00088972|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of celecoxib may be effective in preventing~     breast cancer.~      PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing~     breast cancer in premenopausal women who are at risk for developing the disease.~   "
264480|NCT00088959|"~     This phase I trial is studying the side effects and best dose of celecoxib when given~     together with erlotinib in treating former smokers with stage IIIB, stage IV, recurrent, or~     progressive non-small cell lung cancer. Celecoxib and erlotinib may stop the growth of tumor~     cells by blocking the enzymes necessary for their growth.~   "
264481|NCT00088946|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Green tea extract (Polyphenon® E) contains certain ingredients that may slow~     the growth of tumor cells and prevent the recurrence of cancer. Giving erlotinib or green tea~     extract after surgery may kill any remaining tumor cells and may prevent the recurrence of~     bladder cancer.~      PURPOSE: This randomized phase II trial is studying how well giving erlotinib together with~     green tea extract works in preventing cancer recurrence in former smokers who have undergone~     surgery for bladder cancer.~   "
264482|NCT00088933|"~     This randomized phase I trial studies the side effects, best way to give, and best dose of~     docetaxel when given together with vaccine therapy and sargramostim in treating patients with~     metastatic lung cancer or metastatic colorectal cancer. Vaccines may make the body build an~     immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase~     the number of immune cells found in bone marrow and peripheral blood. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so~     they stop growing or die. Combining vaccine therapy and sargramostim with docetaxel may kill~     more tumor cells.~   "
264483|NCT00088907|"~     Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells~     from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by~     blocking the enzymes necessary for their growth. Combining docetaxel with gefitinib may kill~     more tumor cells. It is not yet known whether docetaxel is more effective with or without~     gefitinib in treating head and neck cancer. This randomized phase III trial is studying~     docetaxel and gefitinib to see how well they work compared to docetaxel alone in treating~     patients with metastatic or locally recurrent head and neck cancer.~   "
264484|NCT00088894|"~     This randomized phase III trial is studying gemcitabine and bevacizumab to see how well they~     work compared to gemcitabine alone in treating patients with locally advanced or metastatic~     pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as~     bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances~     to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by~     stopping blood flow to the tumor. Combining gemcitabine with bevacizumab may kill more tumor~     cells. It is not yet known whether gemcitabine is more effective with or without bevacizumab~     in treating pancreatic cancer.~   "
264485|NCT00088881|"~     This phase II trial is studying how well giving rituximab together with combination~     chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or~     stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide,~     doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so~     they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium~     ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive~     cancer-killing substances to them without harming normal cells. Combining a monoclonal~     antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more~     cancer cells.~   "
264486|NCT00088868|"~     RATIONALE: Drugs used in chemotherapy, such as~     17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop~     cancer cells from dividing so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating~     patients with an advanced solid tumor or lymphoma.~   "
264575|NCT00002604|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine and carmustine in~     treating patients who have solid tumors.~   "
264487|NCT00088855|"~     This phase II trial studies the side effects and how well bortezomib and pegylated liposomal~     doxorubicin hydrochloride work in treating patients multiple myeloma that are experiencing~     symptoms and have not received prior treatment. Bortezomib and pegylated liposomal~     doxorubicin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
264488|NCT00088829|"~     RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict~     a patient's response to treatment and help plan the most effective treatment.~      PURPOSE: This clinical trial is studying how well genetic testing works in predicting~     response to paclitaxel in women who have unresected breast cancer.~   "
264489|NCT00088816|"~     RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may~     kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so~     that it can be removed.~      PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in~     treating patients who are undergoing surgery for stage IV gastric cancer.~   "
264490|NCT00088803|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that may occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This laboratory study is looking at DNA variations in the RASSF1A gene in young~     patients with Wilms' tumor.~   "
264491|NCT00088790|"~     Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to~     patients with advanced solid malignancies A review of the emerging clinical tolerability and~     exposure data from this study in conjunction with preclinical and the available clinical~     pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the~     development of AZD5438 as a potential anti-cancer agent would be discontinued.~   "
264492|NCT00088777|"~     Fibromyalgia (FM) syndrome is a common chronic pain disorder that may benefit from nondrug~     treatment. This study will compare the effectiveness of behavioral preparation, stress~     management education, and fibromyalgia and coping education in relieving the symptoms of FM.~     Each of these nondrug treatments will be combined with physical therapy and physical~     education.~      Specific aims: 1) Evaluate the efficacy of behavioral preparation programs on attrition,~     compliance, and treatment outcomes of self-management rehabilitation for FM syndrome. 2)~     Determine factors that mediate clinical efficacy. 3) Evaluate individual differences in~     treatment responses to delineate who will benefit most from each type of the behavioral~     preparation programs.~   "
264493|NCT00088764|"~     Self-management of rheumatoid arthritis (RA) symptoms using written emotional disclosure~     (ED), coping skills training (CST), or a combination of both may benefit people with RA. The~     purpose of this study is to determine the benefits of ED, CST, or CST and ED together in~     adults with RA. This study will be conducted at Wayne State University in Detroit, Michigan~     and Duke University Medical Center in Durham, North Carolina.~   "
264494|NCT00004193|"~     RATIONALE: ISIS 2503 may kill cancer cells by inhibiting a gene that promotes the development~     and growth of cancer.~      PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have~     metastatic and/or locally recurrent colorectal cancer.~   "
264495|NCT00004187|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine and~     oxaliplatin in treating patients who have advanced or metastatic colorectal cancer that~     cannot be surgically removed.~   "
264496|NCT00004186|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating~     patients who have small cell lung cancer.~   "
264497|NCT00004162|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of liposomal doxorubicin plus combination~     chemotherapy in treating patients who have AIDS-associated non-Hodgkin's lymphoma.~   "
264498|NCT00004096|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining carboplatin and vinorelbine~     in treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
264499|NCT00004080|"~     RATIONALE: Inserting the gene for p53 into a person's brain cells may improve the body's~     ability to fight cancer.~      PURPOSE: Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in~     treating patients who have recurrent, or progressive glioblastoma multiforme, anaplastic~     astrocytoma, or anaplastic mixed glioma that can be removed during surgery.~   "
264500|NCT00004064|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy~     in treating patients who have ovarian, fallopian tube, or peritoneal cancer.~   "
264501|NCT00004040|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Biological~     therapies such as interferon alfa-2b use different ways to stimulate the immune system and~     stop cancer cells from growing.~      PURPOSE: Phase II trial to study the effectiveness of rituximab or interferon alfa-2b in~     treating patients who have chronic lymphocytic leukemia or multiple myeloma in remission.~   "
264502|NCT00004039|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab~     with chemotherapy may kill more cancer cells.~      PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus~     interferon alfa or rituximab in treating patients who have high risk stage III or stage IV~     lymphoma.~   "
264576|NCT00002588|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of topotecan and etoposide in treating~     patients who have recurrent or refractory leukemia.~   "
264503|NCT00003957|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's~     lymphoma.~   "
264504|NCT00003892|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have~     metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy.~   "
264505|NCT00003828|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who~     have stage IV melanoma that has been previously treated.~   "
264506|NCT00003821|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who~     have refractory or recurrent endometrial cancer.~   "
264507|NCT00003810|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more that one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in~     treating patients who have locally advanced or metastatic cancer of the pancreas.~   "
264508|NCT00003798|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation~     therapy in treating patients who have cancer of the pancreas that cannot be removed by~     surgery.~   "
264509|NCT00003786|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with~     metastatic or recurrent colorectal cancer.~   "
264510|NCT00003784|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~     Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing~     substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     monoclonal antibody therapy in treating patients who have newly diagnosed follicular~     non-Hodgkin's lymphoma.~   "
264511|NCT00003760|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have~     stage III or stage IV pancreatic cancer that cannot be surgically removed.~   "
264512|NCT00003708|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of temozolomide in treating patients who~     have advanced solid tumors.~   "
264513|NCT00003681|"~     RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.~     Epoetin alfa may stimulate red blood cell production and be an effective treatment for anemia~     in patients with myelodysplastic syndrome.~      PURPOSE: Phase II trial to study the effectiveness of amifostine with or without epoetin alfa~     in treating patients who have myelodysplastic syndrome.~   "
264514|NCT00003663|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Combining the monoclonal~     antibody rituximab with dexamethasone may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab and dexamethasone in treating~     patients with recurrent or refractory indolent non-Hodgkin's lymphoma.~   "
264515|NCT00003662|"~     RATIONALE: Umbilical cord blood transplantation may be able to replace cells destroyed by~     chemotherapy or radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation in~     treating patients who have hematologic cancer or other hematologic or metabolic diseases.~   "
264516|NCT00003661|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Umbilical cord blood transplantation may be able to replace cells destroyed by~     chemotherapy or radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and~     umbilical cord blood transplantation in treating patients who have hematologic cancer.~   "
264517|NCT00003605|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die. Combining~     chemotherapy and monoclonal antibody therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab plus cyclophosphamide in~     treating patients who have indolent stage III or stage IV non-Hodgkin's lymphoma.~   "
264518|NCT00003542|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa in treating patients~     with advanced kidney cancer.~   "
264519|NCT00003539|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them~     or deliver tumor-killing substances to them without harming normal cells. Combining~     chemotherapy with monoclonal antibody therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody~     therapy in treating women with recurrent or metastatic breast cancer.~   "
264520|NCT00003431|"~     RATIONALE: Flt3L may stimulate a person's immune system and help kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of flt3L given to patients before~     undergoing surgery to remove metastases from colorectal cancer.~   "
266756|NCT00073554|"~     This trial is for patients with acute occlusion of one of the arteries supplying blood to the~     leg. The trial is designed to determine the safety and activity of a novel clot dissolving~     (thrombolytic) drug (alfimeprase).~   "
264521|NCT00003424|"~     RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using tamoxifen~     may fight liver cancer by blocking the absorption of estrogen. It is not yet known whether~     receiving tamoxifen is more effective than no further therapy in treating patients with~     primary liver cancer.~      PURPOSE: Randomized phase III trial to compare high-dose tamoxifen with no further treatment~     in treating patients with liver cancer that cannot be surgically removed.~   "
264522|NCT00088673|"~     The purpose of this Phase III study is to evaluate the efficacy and safety of 3APS compared~     to placebo (inactive substance pill) in patients with mild to moderate Alzheimer’s disease.~   "
264523|NCT00003416|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.~     Interferon alfa may interfere with the growth of the cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus peripheral~     stem cell transplantation followed by interferon alfa in treating patients with Waldenstrom's~     macroglobulinemia.~   "
264524|NCT00003415|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells~     from the side effects of chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus topotecan in treating~     patients with myelodysplastic syndrome.~   "
264525|NCT00003413|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug with peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian~     epithelial cancer.~   "
264526|NCT00088751|"~     Objectives. The proposed clinical study has two goals: First, to assess the efficacy of a~     central nervous system stimulant and an atypical antipsychotic in treating the behavioral~     symptoms of FTD and second, to further characterize the biological markers, including~     genetic, imaging, and CSF proteins, of FTD in relation to our existing group of Alzheimer's~     patients.~      Rationale. Frontotemporal dementia (FTD) is increasingly recognized as an important~     neuropsychiatric disorder. Symptoms of FTD include disinhibition, impulsivity, apathy,~     affective lability, and language dysfunction. The clinical syndrome is associated with~     frontal and/or anterior temporal atrophy on imaging and autopsy. Levels of the CSF proteins~     tau and (Beta)-amyloid 1-42, shown to have diagnostic utility in patients with Alzheimer's~     Disease (AD), have also been found to be abnormal in FTD. FTD is less associated with APOE~     genotype than AD, however some familial cases of FTD are associated with specific mutations~     in the gene encoding the tau protein. Currently, no treatments have been proven to be~     effective for altering the course or clinical symptoms of FTD.~      Design. Study subjects will include 50 male and female patients with mild-moderate~     frontotemporal dementia recruited from participants in NINDS protocol 02-N-0001. In a~     double-blinded crossover 11-week study without a placebo control, patients will be treated~     with a stimulant (dextroamphetamine) and an atypical antipsychotic (quetiapine). The primary~     outcome measures will be the Neuropsychiatric Inventory and the Clinical Global Impression of~     Change. Cerebrospinal fluid, cognitive and genetic measures, brain MRIs, and side effects~     scales will also be collected.~   "
264527|NCT00088738|"~     This study is designed to observe the effects of a panic attack in patients with panic~     disorders and to demonstrate the involvement of Substance P in panic disorder, and thereby,~     further our understanding of its role in this illness. We will measure levels of Substance P~     in the brain by obtaining pictures of the brain using PET and MRI....~   "
264528|NCT00088712|"~     This study will explore the development of visual perception and the brain activity that~     underlies it. It will examine electrical activity in the brain while people are processing~     characteristics of the visual environment, and how that processing might change with~     development.~      Infants who are within 2 weeks on either side of their 4-month birthday may be eligible for~     this study. A parent of the child also participates.~      Parents who join the study are asked basic questions about their family, such as its size and~     ethnic make-up, their infant's birth date, complications of pregnancy or delivery, and any~     health problems of the infant, such as congenital developmental disorders or visual~     abnormalities.~      Each family is seen at the clinic one time for a 45-minute visit. The infant is outfitted~     with an elastic net containing many small sensors that make contact with the scalp. He or she~     is then shown pictures on a computer screen. The sensors in the head net are connected to a~     computer that records the infant's brain activity while the infant watches the pictures on~     the screen. The head net is moistened with warm water before being applied, and is not~     uncomfortable to wear. Towels are available throughout the session to dry any excess moisture~     from the net.~   "
264529|NCT00088699|"~     This study examines whether Ketamine can cause a rapid-next day antidepressant effect in~     patients with Major Depression/Bipolar Disorder .~      Purpose: This study will test whether a single dose of ketamine - a drug that blocks a brain~     receptor called NMDA - can cause a rapid (next day) antidepressant effect in patients with~     major depression. Several medications are effective for treating depression; however, they~     take weeks or months to achieve their full effects. A more rapidly acting antidepressant~     would have a significant impact on the treatment of depression. In a previous study, ketamine~     produced a rapid antidepressant effect within hours, but the effect lasted less than 1 week.~     Understanding how ketamine works may lead to a better understanding of the causes of~     depression and the design of a longer lasting rapidly acting antidepressant.Patients between~     18 and 65 years of age who are currently experiencing an episode of major depression of at~     least 4 weeks duration and have not responded to two treatment trials may be eligible for~     this study. Candidates are screened with a medical and psychiatric history, physical~     examination, and blood and urine tests.Participants undergo the following tests and~     procedures:Medication tapering: Patients who are taking medications for depression are~     tapered off the drugs over a 1- to 2-week period. Ketamine/placebo trial: Patients are given~     a single dose of either ketamine or placebo (an inactive substance), administered~     intravenously (through a vein) over 40 minutes. After 7 days, patients are given another dose~     of study drug in crossover fashion; that is, those who previously took ketamine are switched~     to receive placebo, and those who took placebo are switched to ketamine. Oximetry~     (measurement of blood oxygen), pulse, and blood pressure are measured continuously for 1 hour~     before and 4 hours after each ketamine or placebo dose to monitor safety. Interviews and~     rating scales: Patients complete a series of psychiatric rating scales to assess the effects~     of the study drug on mood and thinking. The rating scales are repeated up to 18 times during~     the study, with each time taking about 15 to 20 minutes. Physical examination and laboratory~     tests: Patients have a physical examination, blood tests, weight measure, and~     electrocardiogram (ECG) at the beginning and end of the study.~   "
264645|NCT00088153|"~     This study is to determine the effects of anorexia nervosa on bone mass and hormone levels in~     adolescents. Whether administration of estrogen, a normal hormone present during puberty, can~     help maintain bone development in girls with anorexia nervosa will be determined.~   "
264530|NCT00088686|"~     Capsaicin to Control Pain Following Third Molar Extraction~      Summary: This study will test the effectiveness of the drug capsaicin in controlling pain~     after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that~     makes them hot, belongs to a class of drugs called vanilloids, which have been found to~     temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery,~     it may have potential for use in many types of surgery and painful illnesses.~      Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom~     tooth) extraction may be eligible for this study. Participants undergo the following~     procedures in three visits:~      Visit 1~      Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a~     temperature probe onto the gums and having the patient rate how warm it is; 2) applying a~     gentle stroke across the gums with the bristles of a small paint brush and having the patient~     say whether or not it feels painful; and 3) applying a light touch to the gums with a small~     needle and having the patient rate the pain intensity following the touch. Following touch~     testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue~     next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either~     capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth.~      Visit 2~      Following repeat the touch testing, patients are sedated with an injection of midazolam. They~     then have another biopsy under local anesthesia on the same side of the mouth as the first~     biopsy. Their mouth is again numbed with an anesthetic, and they are given either a~     pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom~     tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for~     up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and~     side effects. Patients who request pain-relief medication are given acetaminophen and~     codeine. At the end of the study, they are discharged from the clinic and given acetaminophen~     and codeine to take at home, as instructed. They are provided a pain diary to record pain~     ratings and any adverse reactions that might occur until the last visit.~      Visit 3~      Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the~     end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining~     wisdom teeth are removed off-study no sooner than 1 week following the first visit.~   "
264531|NCT00088660|"~     The objectives of this multi-center, randomized, controlled trial are to evaluate the safety~     and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating~     factor (GM-CSF) versus best supportive care or palliative chemotherapy.~   "
264532|NCT00088647|"~     The primary objective of this clinical research study is to evaluate the safety,~     tolerability, and maximum tolerated dose (MTD) of intravenous (IV) MST-997 formulated in~     Intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid~     tumors.~   "
264533|NCT00088634|"~     A 6-week in-patient and out-patient study to test the effectiveness and safety of a new~     medication in the treatment of schizophrenia~   "
264534|NCT00088621|"~     A 1-year outpatient study to test the safety and tolerability of a new medication in the~     treatment of schizophrenia~   "
264535|NCT00088608|"~     The study treatment period is 15 days in length and includes patients with pituitary~     Cushing's disease who are candidates for surgical intervention as well as and patients who~     have recurrent Cushing's post operatively.~   "
264536|NCT00088595|"~     Study evaluating SOM230 in patients with metastatic carcinoid tumors~   "
264537|NCT00088582|"~     5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.~   "
264538|NCT00003358|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of cisplatin plus gemcitabine in treating~     patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary~     peritoneal cancer.~   "
264539|NCT00003305|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who~     have refractory leukemia.~   "
264540|NCT00003259|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients with~     metastatic prostate cancer that has not responded to hormone therapy.~   "
264541|NCT00003256|"~     Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent~     prostate cancer after hormone therapy. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die.~   "
264542|NCT00003214|"~     RATIONALE: Chemosensitizers may increase the effectiveness of a chemotherapy drug by making~     tumor cells more sensitive to the drug.~      PURPOSE: Randomized phase III trial to study the effectiveness of chemosensitivity testing to~     assign treatment for patients with stage III or stage IV ovarian cancer who have undergone~     surgery.~   "
264543|NCT00003213|"~     RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients~     treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron~     is more effective than receiving dexamethasone with metoclopramide for reducing the side~     effects of chemotherapy.~      PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with either~     granisetron or metoclopramide in patients treated with chemotherapy.~   "
264544|NCT00003182|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of cisplatin and gemcitabine in treating~     patients with advanced squamous cell cancer of the head and neck that cannot be surgically~     removed.~   "
264545|NCT00003158|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy~     consisting of carboplatin, etoposide and paclitaxel in treating patients with newly diagnosed~     stage III non-small cell lung cancer.~   "
264546|NCT00003152|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.~     Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation~     therapy and kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     followed by interferon alfa alone or combination chemotherapy plus radiation therapy and~     peripheral stem cell transplantation in treating patients who have previously untreated stage~     III or stage IV follicular non-Hodgkin's lymphoma.~   "
264547|NCT00003097|"~     RATIONALE: A low-fat, balanced diet may prevent disease progression in patients with~     nonmelanomatous skin cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of a low-fat, balanced diet to~     prevent disease progression in patients with nonmelanomatous skin cancer.~   "
264549|NCT00003087|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug with radiation therapy before surgery may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation~     therapy, and surgery in treating patients with cancer of the esophagus that can be surgically~     removed.~   "
264550|NCT00003068|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose mitoxantrone, thiotepa, and~     cyclophosphamide plus autologous peripheral stem cell transplantation and amifostine in~     treating patients with primary, locally advanced, or stage IV breast cancer.~   "
264551|NCT00088569|"~     This study will test a new electrical technique called direct current (DC) polarization that~     is able to change brain activity in subtle ways for a short time. A recent study showed that,~     depending on its direction, the current could make people perform a little better or perhaps~     slightly worse on a test of the function of the brain's frontal lobe. This study will use~     positron emission tomography (PET) scanning to examine how DC polarization affects brain~     activity.~      Healthy volunteers between 20 and 70 years of age who are right handed and who are not taking~     any medications that affect the brain may be eligible for this study. Candidates are screened~     with a brief medical history and neurological evaluation.~      Participants have a PET scan on three different days at least 3 days apart. Each scanning~     session takes 2-1/2 to 3 hours. For the scan, radioactive water is injected into the body~     through a vein. Subjects lie on a bed that slides in and out of the doughnut-shaped scanner,~     with their head held from the back by a padded holder and in front by a custom-molded plastic~     mask with holes for the eyes, nose, and mouth. DC electrodes made of wet sponges are placed~     on the right side of the head and over the left eye and are held in place with elastic~     bandages.~      Three kinds of DC polarization are tested. In two tests the current is the same, but in~     opposite directions. The third is a sham (placebo) condition with no current delivered. Each~     of the three scans is separated by at least 3 days. On each day, a series of scans is done in~     a single session. Before each injection of tracer, the DC current is turned on. This may~     cause a tingling or slight burning on the skin under the electrodes, which disappears when~     the current is turned off. In each session, the subject receives 16 injections of tracer~     about 8 minutes apart, with DC polarization turned on for 4 out of the 8 minutes.~      During most of the 8-minute periods, subjects are shown a pattern of dots about every 2~     seconds. Sometimes the subject just looks at the patterns, and sometimes subjects are asked~     to push a button corresponding to the pattern they saw just before the current one. Sometimes~     they will be asked to push a button corresponding to the pattern that came before that one~     and so on, up to three patterns before the current one. The task lasts for about 2 minutes~     each time, with time to relax in between.~   "
264552|NCT00088556|"~     The purpose of this trial is to study the efficacy and safety of the triplet combination of~     TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small~     cell lung cancer.~   "
264553|NCT00088543|"~     This study involves the use of a drug called Thymoglobulin, which is approved in the USA to~     treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant~     rejection. Thymoglobulin is not approved for the treatment or prophylaxis of graft versus~     host disease in bone marrow transplantation. This study is to evaluate two (2) doses of~     Thymoglobulin and its safety and effectiveness when used with a myeloablative conditioning~     regimen prior to receiving a stem cell transplant (also called bone marrow transplantation)~     from a matched, related donor.~      A myeloablative regimen is typically composed of chemotherapy and radiation and destroys the~     subject's existing bone marrow.~      Subjects meeting all inclusion and exclusion criteria and who have a relative with matching~     (genetically similar) stem cells who are also willing to donate them (i.e.~     matched-related-donor) are eligible to participate in this study. Following myeloablative~     therapy, the donor's cells are then transplanted (i.e. infused) into the subject's blood~     stream.~      One of the most common complications of this type of transplant is graft-versus-host disease~     (GvHD). This is a condition where the transplanted donor cells attack the transplant~     recipient's body. Treatments, such as cyclosporine, are used to minimize the risk of GvHD~     following stem cell transplantation.~      To enter this study, subjects must be having a matched-related donor stem cell transplant. If~     a subject qualifies for entry into this study, he/she will be assigned to receive~     Thymoglobulin at a dose of 4.5 mg/kg or 8.5 mg/kg. The treatment assignment is random and is~     not chosen by the subject or their physician.~      Subjects are admitted to the hospital for the transplant procedure and are treated with~     Thymoglobulin over 3-5 days just prior to receiving the donor stem cells. The subject will~     also receive standard GvHD prophylaxis with cyclosporine. Methotrexate, which is commonly~     used by transplant centers to minimize the risk of GvHD, will not be used in this study.~      Subjects will be monitored during treatment with Thymoglobulin and during the transplant~     hospitalization. Additional subject monitoring occurs at month 1, 100 days and 6 months~     following the transplant.~      Approximately 60 study subjects from approximately 14 transplant centers in the United States~     and Canada will be enrolled.~   "
264554|NCT00003055|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with locally advanced or metastatic esophageal or gastric cancer.~   "
264555|NCT00003050|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in~     treating patients with stage IIB or stage III breast cancer.~   "
264556|NCT00003002|"~     RATIONALE: Vaccines made from the HER2/neu antigen may make the body build an immune response~     and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune~     cells found in bone marrow or peripheral blood.~      PURPOSE: Phase I trial to study the effectiveness of HER-2/neu vaccine plus GM-CSF in~     treating patients who have stage III or stage IV breast cancer, stage III or stage IV ovarian~     cancer, or stage III or stage IV non-small cell lung cancer.~   "
264557|NCT00003000|"~     RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine~     in different ways may offer more pain relief.~      PURPOSE: This randomized clinical trial is studying how well morphine injected directly into~     the underarm area works compared with morphine injected into the back of the shoulder in~     treating pain in patients who have breast cancer and who are undergoing axillary lymph node~     dissection.~   "
264558|NCT00002984|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than on drug and combining chemotherapy with radiation therapy may kill more~     tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus~     radiation therapy in treating patients with advanced or metastatic cancer of the esophagus.~   "
264559|NCT00002921|"~     RATIONALE: Some tumors need growth factors produced by the body to keep growing. Suramin may~     interfere with the growth factor and stop the tumor from growing.~      PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with stage~     III or stage IV adrenocortical cancer.~   "
264577|NCT00002572|"~     RATIONALE: Biological therapy uses different ways to stimulate the immune system and stop~     cancer cells from growing. Cytotoxic T cells combined with interleukin-2 may be an effective~     treatment for recurrent brain tumors.~      PURPOSE: Phase I trial to study the effectiveness of cytotoxic T cells and interleukin-2 in~     treating adults with recurrent brain tumors.~   "
264560|NCT00002833|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Colony stimulating factors such as filgrastim may increase the number of immune cells found~     in bone marrow or peripheral blood and may help a person's immune system recover from the~     side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation~     plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.~   "
264561|NCT00088530|"~     BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows~     reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural~     similarities with mitoxantrone as well as general similarities with anthracyclines (such as~     the tricyclic central quinoid chromophore).~      The primary study objective is to compare the efficacy of BBR 2778 to a selection of single~     agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a~     selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a~     subset of this patient population.~   "
264562|NCT00002832|"~     RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia,~     myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone~     marrow transplantation.~      PURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell~     transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic~     myelogenous leukemia that has relapsed after bone marrow transplantation.~   "
264563|NCT00002831|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus~     peripheral stem cell transplantation in treating patients with chronic myelogenous or acute~     leukemia.~   "
264564|NCT00002824|"~     RATIONALE: Inserting the gene for herpes virus into a person's cells may improve the body's~     ability to fight cancer or make the cancer more sensitive to chemotherapy using antiviral~     drugs such as ganciclovir.~      PURPOSE: Phase I trial to study the effectivenesss of gene therapy in treating patients with~     primary brain tumors.~   "
264565|NCT00002784|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It~     is not yet known if high-dose combination chemotherapy plus peripheral stem cell~     transplantation is more effective than standard combination chemotherapy for breast cancer.~      PURPOSE: Randomized phase III trial to compare high-dose combination chemotherapy plus~     peripheral stem cell transplantation with standard combination chemotherapy in treating women~     with stage II or stage III breast cancer.~   "
264566|NCT00002779|"~     RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop cancer~     cells from dividing so they stop growing or die. Combining more than one drug may kill more~     cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of fludarabine plus octreotide in treating~     patients who have relapsed low-grade non-Hodgkin's lymphoma.~   "
264567|NCT00002754|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to determine the effectiveness of monoclonal antibody therapy in~     treating patients who have primary or metastatic melanoma or brain tumors.~   "
264568|NCT00002753|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody in treating~     patients with recurrent gliomas.~   "
264569|NCT00002688|"~     RATIONALE: Some cancers become resistant to chemotherapy drugs. Combining cyclosporine with~     chemotherapy may prevent resistance to the drugs and allow the cancer cells to be killed.~      PURPOSE: Randomized phase II trial to study the effectiveness of adding cyclosporine to~     combination chemotherapy in treating patients with relapsed or refractory acute myeloid~     leukemia.~   "
264570|NCT00002675|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with retinoblastoma.~   "
264571|NCT00002665|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or~     without bone marrow transplantation in treating patients who have acute lymphocytic leukemia.~   "
264572|NCT00002630|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining peripheral stem cell transplantation with chemotherapy and radiation therapy may~     allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus total-body~     irradiation and peripheral stem cell transplantation in treating patients with multiple~     myeloma in first relapse.~   "
264573|NCT00002627|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune~     cells that were destroyed by chemotherapy used to kill tumor cells, allowing higher doses of~     chemotherapy to be used.~      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel when added to high-dose~     combination chemotherapy followed by peripheral stem cell transplantation in treating women~     with breast cancer at high risk of relapse.~   "
264574|NCT00002618|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Giving the drugs in different doses may kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various~     combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.~   "
264578|NCT00002542|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses~     different ways to stop tumor cells from dividing so they stop growing or die.~      PURPOSE: Phase III trial to study the effectiveness of tamoxifen following surgery and~     chemotherapy in treating women who have stage I breast cancer at high risk of recurrence or~     stage II or stage III breast cancer.~   "
264579|NCT00002535|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     tumor cells from growing. Combining biological therapies with indomethacin and~     cyclophosphamide may kill more tumor cells.~      PURPOSE: Phase II trial to compare the effectiveness of indomethacin and biological therapy~     with or without cyclophosphamide in treating patients who have advanced melanoma that has not~     responded to previous therapy.~   "
264580|NCT00002529|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy may~     fight breast cancer by blocking the uptake of estrogen. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which~     treatment regimen is more effective for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy during or~     after combination chemotherapy or hormone therapy alone in treating perimenopausal or~     postmenopausal women who have stage II or stage IIIA breast cancer.~   "
264581|NCT00088517|"~     This study will investigate the use of [11C]NNC-112 in positron emission tomography (PET)~     scanning. PET is a technique that uses radioactive isotopes called tracers to provide images~     of the brain. Injected into the body, the isotopes lose their radioactive strength over~     time, sending out rays that can be picked up and seen by special detectors connected to a~     computer. The computer then makes a picture of the brain. This study will examine the~     distribution in the body of a new tracer called [11C]NNC-112.~      Healthy normal volunteers between 18 and 70 years of age may be eligible for this study.~     Candidates are screened with a physical examination and blood and urine tests, including a~     urine drug screen. Women up to age 55 also have a pregnancy test.~      Participants have a PET scan using the [11C]NNC-112 tracer. For this procedure, a catheter~     (small plastic tube) is placed into a vein in the subject's arm for injecting the tracer.~     Then, the subject lies on the scanner bed. After a preliminary transmission scan, the~     tracer is injected, and PET scans are taken from the head to the upper thigh over a period of~     about 2 hours to show the distribution of radioactivity in the body. Blood pressure,~     breathing rate, and heart rate are checked before and after injection of the tracer, and~     blood and urine samples are collected after the PET scan.~   "
264582|NCT00088504|"~     This trial is designed to test whether or not the addition of merimepodib (MMPD) to the~     standard therapy of pegylated interferon and ribavirin will result in a positive treatment~     response for people who have not previously responded to this therapy. Approximately 315~     subjects will be enrolled in this research study at approximately 55 clinical sites in the~     United States. There will be three study groups. Everyone in the study will receive Pegasys®~     (pegylated interferon) and Copegus® (ribavirin) at the normally prescribed doses. Two of the~     groups will also receive the study drug merimepodib (MMPD) twice a day, one group at each~     dose level being tested. The third group will take a placebo instead of MMPD, with the~     Pegasys® and Copegus®.~      After the first 24 weeks of treatment, blood tests will be done to see if subjects are~     responding to treatment. If they are responding, they will continue receiving study treatment~     in the study for another 24 weeks. If they are not responding, they will stop study~     treatment. Everyone who is responding will be monitored for 24 weeks after the last dose of~     medication, to see how long the response lasts.~      Evaluations will be performed during the study to look at the safety of the Pegasys®/Copegus®~     and MMPD or placebo combination, and to see how the combination is working by measuring~     Hepatitis C Virus in the blood.~      At some of the clinical sites performing the study, some subjects may also participate in~     additional testing to look at the metabolism of the drugs, or to look at the immune response~     to Hepatitis C virus infection and treatment.~   "
264583|NCT00088491|"~     This is a randomized, double-blind study to determine how well intramuscular (IM) olanzapine~     depot works compared to oral olanzapine; evaluate the safety and tolerability of IM~     olanzapine depot compared to oral olanzapine; evaluate different doses of IM olanzapine~     depot; and determine the blood levels of IM olanzapine depot in patients at different points~     in time after an injection.~   "
264584|NCT00088478|"~     Key objectives of this clinical study are to:~        -  Determine how well intramuscular (IM) olanzapine depot works compared to placebo~        -  Evaluate the safety and tolerability of IM olanzapine depot compared to placebo~        -  Evaluate different doses of IM olanzapine depot compared to placebo to identify the best~          dose(s).~   "
264585|NCT00088465|"~     This is a long-term, open-label clinical study designed to enable longer-term treatment of~     patients completing other clinical studies with intramuscular olanzapine depot.~      Key objectives of the study are to:~        -  Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,~        -  Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,~        -  Determine the blood levels of IM olanzapine depot in patients during long-term treatment~   "
264586|NCT00088452|"~     The purpose of this study is to determine the best initial treatment for childhood absence~     epilepsy.~   "
264592|NCT00088361|"~     This study will determine how breathing motions may affect positron emission tomography (PET)~     scans. It has been discovered that the quality of PET scans varies according to which part of~     the breathing cycle patients hold their breath.~      NIH Clinical Center patients 12 years of age and older who are scheduled to have PET and~     computed tomography (CT) scans as part of their standard medical care may be eligible for~     this study.~      Participants have their scheduled PET or CT scan as they normally would and are asked to hold~     their breath after breathing out, as is usual. In addition, for this study, patients are also~     asked hold their breath after breathing in and again at a point between breathing in and out.~     Each breath-hold is for around 15 seconds. The scans for each of the three different~     breath-holds are examined for differences.~      Some patients may also be asked to breathe through a tube called a pneumotachometer, or~     spirometer, to determine their normal breathing pattern. This involves breathing through a~     mouthpiece similar to a snorkel mouthpiece and takes about 2 minutes.~   "
275371|NCT00000282|"~     The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.~   "
264587|NCT00088426|"~     This study will examine how holoprosencephaly (HPE) affects people, how they change over~     time, and what genes may be involved in the cause of the disorder. HPE is a defect of brain~     development in utero in which the forebrain fails to sufficiently divide into two~     hemispheres, resulting in a single-lobed brain and skull and facial malformations. In most~     cases, the defects are so severe that babies die before birth. There are three~     classifications of HPE. In alobar HPE the brain does not divide at all; this form is usually~     associated with severe facial deformities. In semilobar HPE the hemispheres divide somewhat,~     causing an intermediate form of the disorder. In lobar HPE, the mildest form, separation of~     hemispheres is nearly normal.~      Patients with HPE and their direct blood relatives may participate in this study. Patients~     are seen by a team of medical specialists at the NIH Clinical Center for the following~     procedures:~        -  Physical and neurological examination~        -  Eye examination~        -  Imaging studies, such as echocardiogram, abdominal ultrasound, brain MRI~        -  Electroencephalogram (EEG)~        -  Hearing evaluation~        -  Blood and urine samples for genetic and endocrine studies, routine blood chemistries,~          urinalysis, and urine electrolytes~        -  Other consultations as needed~        -  Possibly photographs, including front and side views of the face and other body parts~          that may be involved in HPE, such as the eyes, teeth, hands, and feet~      Parents will be asked questions about the child's prenatal, birth, newborn, and past medical~     history, growth, behavior and development, and therapy and medication.~      Because HPE is a genetic disorder and gene changes can be passed on in a family, parents will~     also be asked to undergo the following procedures:~        -  Completion of a medical and family history form~        -  Physical and neurological examination~        -  Blood and urine samples (for mothers only)~        -  Specialty consultations as indicated~        -  Possibly photographs, including front and side views of the face and other body parts~          that may be involved in HPE, such as the eyes, teeth, hands, and feet~        -  Psychosocial study. Some parents will be asked to participate in a telephone interview~          or complete a questionnaire, or both, about their attitudes, beliefs, and concerns about~          how they and their family cope with their child's condition. Some questionnaires may~          include questions about aspects of their marriage and personal feelings and experiences.~      Parents will meet with a doctor and a genetics nurse to discuss the results of the tests and~     answer questions. Parents may be asked to bring their child back to the NIH after 2 years for~     follow-up examination and possible additional or repeat testing.~   "
264588|NCT00088413|"~     Background:~        -  Many cancers produce two proteins, carcinoembryonic antigen (CEA) and mucin-1 (MUC-1).~        -  The PANVAC-V priming vaccine and PANVAC-F boosting vaccine contain human genes that~          cause production of CEA and MUC-1, which can be used as a target for the immune system~          to attack the cancer. The vaccines also contain genes that cause production of other~          proteins that enhance immune activity.~        -  Sargramostim is a protein that boosts the immune system.~      Objectives:~        -  To evaluate the safety and effectiveness of PANVAC-V and PANVAC-F in patients with~          advanced cancer.~        -  To document the immune response to the vaccines and any anti-tumor responses that may~          occur.~      Eligibility: Patients 18 years of age and older with advanced cancer whose tumors produce CEA~     or MUC-1 protein~      Design:~        -  This trial has four arms: the first arm includes 10 patients with advanced colorectal~          cancer; the second arm includes 10 to 15 patients with any advanced non-colorectal~          cancer that produces either EA or MCU-1; the third arm includes about 12 patients with~          advanced breast cancer; the fourth arm includes about 12 patients with advanced ovarian~          cancer.~        -  All patients receive PANVAC-V on study day 1, followed by PANVAC-F on days 15, 29 and~          43. The vaccines are given by injection under the skin. Sargramostim is injected at the~          vaccination site on the day of each vaccination and for the next 3 days following~          vaccination.~        -  Patients whose disease has not worsened after the last boosting vaccination may receive~          up to 12 additional monthly boosting vaccinations. Following the 12 vaccinations,~          patients may receive vaccine every 3 months. Patients whose scans show that their~          disease has progressed, but who are otherwise clinically stable may revert back to~          monthly injections.~        -  Patients undergo apheresis to collect white blood cells (lymphocytes) on day 1 and day~          71 of the study to measure the immune response to the treatment. Blood is collected~          through a needle placed in one arm and directed through a cell separator machine where~          the lymphocytes are extracted. The rest of the blood components are returned to the~          patient through the same needle.~        -  Patients are monitored with frequent blood tests and periodic imaging tests (scans) to~          monitor for safety and the response to treatment.~   "
264589|NCT00088400|"~     Study Objectives:~      Primary Objective:~      To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best~     standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma~     multiforme.~      Secondary Objectives:~      To assess the safety of intratumoral/interstitial therapy with TransMID compared to best~     standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma~     multiforme.~      To evaluate possible differences in efficacy and/or safety with TransMID associated with~     differing degrees of transferrin receptor expression in tumor tissue and serum~     anti-diphtheria toxin antibody titer levels.~      Study Design:~      Multicenter, open label, randomized study comparing TransMID with a chemotherapeutic regimen~     considered to be best standard of care and consisting of either nitrosureas, platinum~     compounds, temozolomide, procarbazine or PCV (procarbazine, lomustine (CCNU) & vincristine).~     A planned interim analysis of the primary efficacy endpoint will be conducted after~     approximately 50 percent of the required events have been observed.~   "
264590|NCT00088387|"~     This study will examine the effect of the drugs lithium and divalproex (Depakote) on tau~     proteins, a type of protein in the brain and spinal fluid that are altered in patients with~     Alzheimer's disease. Both drugs are approved by the Food and Drug Administration to treat~     mood disorders, and both have been shown in animal studies to decrease the amount of altered~     tau protein. This study will determine whether lithium alone or in combination with~     divalproex reduces the altered tau protein in the spinal fluid of patients with Alzheimer's~     disease.~      Patients with Alzheimer's disease who are between 40 and 90 years of age may be eligible for~     this study. Candidates are screened with a medical history and physical examination,~     neurologic and neuropsychological evaluation, blood and urine tests, electrocardiogram (EKG),~     and, if needed, a magnetic resonance imaging (MRI) scan of the brain.~      Participants undergo the following tests and procedures:~        -  Drug treatment: Patients take study drugs for 6 weeks.~        -  Weekly clinic visits: Patients come to the clinic once a week for a physical~          examination, blood and urine tests, a review of drug side effects, and to receive the~          next week's supply of medications.~        -  Lumbar puncture (spinal tap): Patients have a lumbar puncture at study weeks 2, 4, and 6~          to measure various brain chemicals and tau proteins in the cerebrospinal fluid (CSF),~          which bathes the brain and spinal cord. For this test, a local anesthetic is given and a~          needle is inserted in the space between the bones in the lower back where the CSF~          circulates below the spinal cord. A small amount of fluid is collected through the~          needle.~        -  Follow-up visit: Two weeks after completing the study medication, patients return to the~          clinic for a final evaluation, including a physical examination and blood and urine~          tests.~   "
264591|NCT00088374|"~     This study will examine whether the drug 17AAG (17-allylamino 17-demethoxygeldanamycin) can~     shrink kidney tumors in patients with Von Hippel-Lindau disease (VHL), a rare, inherited~     syndrome in which patients develop tumors in certain parts of the body. 17AAG contributes to~     the destruction of proteins in cells that may play in role in causing cancer and spurring~     tumor growth. The study will also look at the effect of 17AAG on other tumors patients may~     have that are caused by VHL, on the amount of blood vessels in the tumors, on the biologic~     activity of the tumor, and on cells circulating in the bloodstream, as well as the safety of~     the drug and its impact on the kidney tumor in patients whose tumor(s) is removed.~      Patients 18 years of age and older with von Hippel-Lindau disease who have at least one~     kidney tumor large enough to pose a risk of metastasis (spread of cancer to other parts of~     the body) may be eligible for this study. Candidates are screened with a medical history and~     physical examination, computed tomography (CT) scan, brain magnetic resonance imaging (MRI),~     see below), and blood and urine tests. Additional tests, including a 24-hour urine~     collection, ultrasound of the testicles in men, hearing test, eye exam, and MRI of the spine,~     may be done if recent test results are not available.~      Participants undergo the following tests and procedures:~      MRI: This test uses a strong magnetic field and radio waves to show structural and chemical~     changes in tissue. During the scan, the patient lies on a table in a narrow cylinder~     containing a magnetic field, wearing earplugs to muffle loud noises that occur with~     electrical switching of the magnetic fields. A catheter (plastic tube) is inserted into the~     patient's arm to administer a contrast dye that enhances the images.~      17AAG treatment: Patients receive 17AAG infusions into a vein once a week for 3 weeks out of~     every 4, for 3 months. The infusions last up to 1 to 2 hours.~      Repeat testing: After 3 months, patients have repeat MRI scans to measure changes in tumor~     activity, blood flow, and number of blood vessels in the tumor since the pretreatment scans.~     They may have additional tests, including a CT scan, eye exam, and other tests to evaluate~     the effect of 17AAG on the tumors.~   "
264626|NCT00088179|"~     During a heart bypass procedure, a substance called complement is activated by the body.~     This complement activation causes an inflammatory response that can lead to side affects~     such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study~     is to find out if the study drug (pexelizumab), that blocks complement activation, can~     reduce such side effects and be given safely to patients requiring the bypass procedure with~     the use of the heart-lung machine.~   "
264593|NCT00088348|"~     This study will identify patients with anterior segment disease who may be eligible to~     participate in current or future NEI studies on this disease. Anterior segment disease~     includes all disorders that affect the eye surface, anterior chamber, iris and ciliary body~     and lens of the eye. The eye surface is composed of the cornea, conjunctiva, eyelids,~     lacrimal and meibomian glands, and the interconnecting nerves.~      Patients of any age with anterior segment disease may be eligible for this screening study.~     Participants will be evaluated with some or all of the following tests and procedures,~     depending on the nature of their eye problem:~        -  Medical history and brief physical examination.~        -  Eye examination, including measurement of visual acuity (eye chart) and eye pressure,~          examination of the pupils, eye movements, structures in the front of the eye (cornea,~          conjunctive, etc.), the lens, and the structures in the back of the eye (retinal, optic~          nerve, etc.).~        -  Photographs of the eye to help assess the status of the cornea and conjunctive and to~          evaluate any changes that may occur in the future.~        -  Assessment of tear and surface status. The amount of tears the eyes can produce is~          measured by placing a small piece of sterile paper in the corner of the eye every 5~          minutes. Special orange and green dyes are placed in the eyes to determine the health~          status of the surface of the eye.~        -  Corneal or conjunctival biopsy. A small tissue sample from the surface of the eye may be~          removed for laboratory examination to help diagnose a condition that is unclear. For~          this procedure, the eye is numbed with anesthetic eye drops. The required tissue is~          collected, an antibiotic ointment is placed in the eye to prevent infection, and a patch~          may be placed over the eye for 12 to 24 hours.~        -  Blood draw for tests to study the cause of the patient's eye disease.~        -  Other diagnostic tests as needed.~        -  DNA testing to look for a genetic pattern associated with the patient's eye disease.~      Patients who are found eligible for an NEI study will be offered participation in that study.~     Patients who are not eligible for current studies will be advised about treatment options.~   "
264594|NCT00088335|"~     This study will identify abnormalities of a protein called alpha synuclein that is found in~     the brain of patients with Parkinson's disease and related disorders to see if it can serve~     as a disease marker. There is currently no treatment that will cure or delay progression of~     Parkinson's disease. Thus, there is a need to find disease markers that can help diagnosis~     the disease, follow its progression, and monitor the effects of treatment. This study will~     examine and compare alpha synuclein from blood and cerebrospinal fluid (the fluid that bathes~     the brain and spinal cord) of patients with Parkinson's disease, patients with variants of~     the disease, and healthy normal volunteers to determine differences in the protein that might~     serve as a disease marker.~      Patients with neurodegenerative disorders such as Parkinson's disease and Parkinson plus~     disorders (other diseases that are variants of Parkinson's disease) and healthy volunteers~     between 18 and 80 years of age may be eligible for this study. Candidates are screened with a~     medical history, physical examination, neurological evaluation, and blood tests. A brain MRI~     (magnetic resonance imaging) scan is done if needed for diagnosis.~      All participants have a blood sample drawn and a lumbar puncture (spinal tap). For the lumbar~     puncture, a local anesthetic is given and a needle is inserted in the space between the bones~     in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small~     amount of fluid is collected through the needle. The fluid is analyzed for specific proteins~     and chemicals that are leaked from the brain in various disease states and that cannot be~     measured in blood.~      Participation of healthy volunteers is completed after the blood draw and lumbar puncture.~     Patients with Parkinson's and related diseases return to the clinic once a year for 2 years~     for a repeat blood draw and lumbar puncture to follow changes in the alpha synuclein protein~     and to monitor disease progression. Patients with specific proteins of interest may also be~     asked to come for a repeat lumbar puncture 6 months after the first procedure.~   "
264595|NCT00088309|"~     This study will examine the long-term effects, particularly on bone metabolism, of the drug~     tenofovir DF in children with HIV infection. Tenofovir DF is approved for treating~     HIV-infected adults, but its use in children has not yet been approved. The drug may be~     helpful for children who have been treated with many other drugs and still have detectable~     HIV in their blood despite ongoing therapy. In a previous study, many children given~     tenofovir DF responded well, with increases in T-cell counts and decreases in viral load.~     However, many children also experienced bone thinning. This study will explore the problem of~     bone thinning in children taking tenofovir DF in combination with highly active~     antiretroviral therapy (HAART).~      HIV-infected patients from 4 to 20 years old who are taking tenofovir DF or for whom~     tenofovir DF treatment has been recommended may be eligible for this 3-year study.~      Participants take tenofovir DF every day in addition to their antiretroviral therapy. They~     have frequent follow-up visits for tests and procedures as follows:~        -  Study days 0, 2, and 4: blood tests.~        -  Screening and every study visit starting day 6: Physical exam, medical history, blood~          and urine tests.~        -  Baseline and every 48 weeks: Dental and eye examinations, kidney ultrasound, tuberculin~          skin testing, chest x-ray, electrocardiogram and echocardiogram, computed tomography~          (CT) scan, neuropsychological testing and neurologic assessment.~        -  The bone age hand x-rays are done every 24 weeks, unless the growth plates are fused~          (i.e. the child has stopped growing)~        -  DEXAs are done at 0, 12, 24 weeks and every 24 weeks thereafter. Dual energy x-ray~          absorptionometry (DEXA) scan is used to assess bone density. The patient lies still on a~          table while the spine and hip are scanned using a small amount of radiation. Only the~          spine and hip are scanned in the DEXA scan test.~        -  Baseline and week 24: Optional bone biopsy. Some patients are asked to undergo a bone~          biopsy to better understand the effect of Tenofovir DF on bone. For the procedure, the~          child is given a sedative. The skin over the hipbone is numbed with a small needle, a~          small incision is made and a larger needle is inserted into the bone. Some of the bone~          tissue is withdrawn through the needle and the incision is closed.~        -  Possible lumbar puncture (spinal tap): This optional procedure analyzes cerebrospinal~          fluid (CSF), the fluid that bathes the brain and spinal cord. The patient is given a~          local anesthetic and a needle is inserted into the space between the bones in the lower~          back where the CSF circulates below the spinal cord. A small amount of fluid is~          collected through the needle. There is no specific schedule for this procedure if the~          patient opts for it.~      Patients who are benefiting from tenofovir DF therapy but show signs of bone effects are~     offered treatment with pamidronate (Aredia), a drug used to treat hypercalcemia (too much~     calcium in the blood). Patients who stop taking tenofovir DF because of bone toxicity~     continue to be followed on the regular study schedule. Those who stop the drug for toxicity~     other than bone toxicity or for toxicity not related to tenofovir DF are followed every 4~     weeks until their laboratory test results improve.~   "
264596|NCT00088296|"~     This study will examine the effects of morphine on leuteinizing hormone, testosterone,~     adrenocorticotropic hormone and cortisol in men. The use of long-term opioids, such as~     morphine, to treat patients with pain is increasing, despite a dearth of information about~     their effects on hormones. The study will also look at the effect of chronic pain on these~     hormone levels and the effect of placebo on pain.~      Men between 30 and 65 years of age who have had moderate to severe chronic pain due to~     osteoarthritis for at least 3 months and healthy, pain-free men in the same age range may be~     eligible for this study. Patients taking an opioid-based medication such as percocet,~     vicodin, or morphine for pain relief, as well as patients who are not taking opioids, may~     participate. Candidates are screened with a medical history, physical examination, blood~     tests, including a blood test to look for possible pain genes, electrocardiogram, x-ray,~     and questionnaires that assess the impact of pain on functional level and psychological well~     being.~      This is a four-part study. Healthy volunteers and patients who are taking opioids for their~     arthritis pain end their participation after Part I; those who are not taking opioids~     continue with Parts II, III, and IV, as follows:~      Part I: Participants are admitted to the NIH Clinical Center at 4 p.m. for an overnight stay.~     At 6 p.m. a catheter (plastic tube) is placed in a vein in the forearm and remains in place~     throughout the night. Blood samples of 3 cc's each (less than a teaspoon) are collected~     through the catheter every 20 minutes for 12 hours, from 8 p.m. until 8 a.m. Participants~     also collect their urine starting from 8 a.m. on the morning of hospital admission and~     continue the collection throughout their 24-hour hospital stay. Patients are discharged at~     the completion of the blood sampling.~      Part II: Patients are randomly assigned to take morphine (MS Contin), placebo, or standard~     treatment, which consists of anti-inflammatory medications and acetaminophen as needed, but~     no opioids. (Patients in groups I and II are also permitted to take anti-inflammatory drugs~     and acetominophen, in addition to their study medication.) Patients are monitored for drug~     side effects by phone twice a week, and medication doses are adjusted as needed. The morphine~     dose is gradually increased over a 4-week period if no side effects develop. After 2 weeks on~     the highest dose of morphine, hormone blood levels are measured and patients complete~     questionnaires. Patients are readmitted to the hospital for a repeat blood sampling and blood~     collection as in Part I. Patients on morphine and placebo are then gradually tapered off drug~     over 12 days and remain drug-free for 2 days before starting Part III.~      Part III: All patients are given morphine in this part of the study and are monitored for~     drug side effects by phone twice a week, with doses adjusted as needed. The morphine is~     gradually increased over a 6-week period if no side effects develop and is maintained at the~     highest dose for another 8 weeks. Hormone levels are measured and the blood and urine studies~     and questionnaires are repeated. Patients interested in continuing long-term treatment with~     MC Contin are referred back to their physicians with recommendations to that effect.~      Part IV: Patients are followed by phone for 6 months, at which time they return to the~     Clinical Center for hormone level measurements, repeat blood and urine tests, and~     questionnaires.~   "
264597|NCT00088283|"~     Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug,~     MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not~     been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may~     slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the~     eye.~      The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a~     “pretend” injection. In addition, the purpose of this study is to measure the action of the~     study drug in the body over a period of time and to check for the presence of the study drug~     in your blood (called pharmacokinetics or PK).~      This study will involve approximately 90 people. People who decide to participate will have~     an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™~     and one of which is a “pretend” injection.~   "
264598|NCT00088270|"~     Multi-center, randomized Phase II study to evaluate the efficacy and safety of~     OSI-7904Lversus 5 FU/LV in biliary tract cancer.~   "
264599|NCT00088257|"~     To study pre- and post-natal influences on the development of childhood asthma-related immune~     responses.~   "
264600|NCT00005884|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of eflornithine may be an effective way to~     prevent the recurrence of or further development of skin cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in~     preventing skin cancer in patients who have previously received treatment for early stage~     skin cancer.~   "
264601|NCT00005852|"~     RATIONALE: Bone marrow from donors may be able to treat patients with severe aplastic anemia~     and patients whose bodies have rejected previous bone marrow transplantation.~      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating~     patients who have severe aplastic anemia or whose bodies have rejected previous bone marrow~     transplant.~   "
264602|NCT00005805|"~     RATIONALE: Giving St. John's wort may be effective in relieving fatigue in patients with~     cancer who are undergoing chemotherapy or hormone therapy.~      PURPOSE: Randomized phase III trial to determine the effectiveness of St. John's wort in~     relieving fatigue in patients who are undergoing chemotherapy or hormone therapy for cancer.~   "
264603|NCT00005633|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with stage III or stage IV melanoma.~   "
264604|NCT00005624|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of CI-994 in treating patients who have~     advanced myeloma.~   "
264605|NCT00005614|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating elderly women~     who have metastatic breast cancer.~   "
264606|NCT00005611|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of BMS-188797 in treating patients who have~     advanced solid tumors that have not responded to previous treatment.~   "
264607|NCT00004902|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of tocladesine in treating patients who~     have recurrent or refractory multiple myeloma.~   "
264608|NCT00004901|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus~     radiation therapy in treating patients who have advanced mouth cancer.~   "
275372|NCT00000281|"~     The purpose of this study is to evaluate maintenance neuroleptics for Schizophrenic patients~     who are cocaine abusers.~   "
264609|NCT00004897|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.~     Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug~     and combining chemotherapy with interferon alfa, surgery, and/or radiation therapy may kill~     more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and interferon~     alfa followed by surgery and/or radiation therapy in treating patients who have stage I,~     stage II, or stage III esophageal cancer.~   "
264610|NCT00004875|"~     RATIONALE: Heparin or enoxaparin may be effective in preventing the formation of blood clots~     in patients with cancer who are undergoing surgery to remove the tumor.~      PURPOSE: Randomized clinical trial to compare the effectiveness of heparin with that of~     enoxaparin in patients who have cancer.~   "
264611|NCT00004265|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who~     have recurrent or refractory non-small cell lung cancer.~   "
264612|NCT00004264|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells~     from the side effects of chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel, cisplatin, and~     amifostine in treating patients who have advanced non-small cell lung cancer that cannot be~     surgically removed.~   "
264613|NCT00004263|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. UCN-01 may make cancer cells more sensitive to cytarabine.~      PURPOSE: Phase I trial to study the effectiveness of cytarabine and UCN-01 in treating~     patients who have refractory or relapsed acute myelogenous leukemia or myelodysplastic~     syndrome.~   "
264614|NCT00004258|"~     RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of EMD 121974 in treating patients who have~     locally advanced or metastatic cancer.~   "
264615|NCT00004169|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor~     to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and~     peripheral stem cell transplantation in treating patients who have recurrent or refractory~     Hodgkin's disease.~   "
264616|NCT00004159|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of gemcitabine plus paclitaxel in~     treating patients who have advanced non-small cell lung cancer or other solid tumor.~   "
264617|NCT00003942|"~     RATIONALE: Inserting the gene for RevM10 into a person's peripheral stem cells may improve~     the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of RevM10-treated stem cells plus~     chemotherapy and peripheral stem cell transplantation in treating patients who have~     HIV-related non-Hodgkin's lymphoma.~   "
264618|NCT00003936|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who~     have recurrent or refractory Hodgkin's disease.~   "
264619|NCT00003929|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining chemotherapy with radiation therapy may kill more cancer cells.~     Colony-stimulating factors such as filgrastim allow doctors to give higher doses of~     chemotherapy drugs to kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of lomustine, procarbazine, filgrastim,~     and radiation therapy in treating patients who have primary central nervous system lymphoma.~   "
264620|NCT00002506|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of isotretinoin may be an effective way to~     prevent cancer or stop cancer from growing. Interferon alfa may interfere with the growth of~     cancer cells. Combining isotretinoin and interferon may be an effective treatment for some~     recurrent cancers.~      PURPOSE: Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in~     treating patients with recurrent cancer.~   "
264621|NCT00002504|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill metastatic cancer~     cells. Interferon alfa may interfere with the growth of the cancer cells. Combining~     interleukin-2 and interferon alfa may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 plus interferon alfa in~     treating adults with metastatic cancer.~   "
264622|NCT00002462|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining radiation therapy with combination chemotherapy may kill~     more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no~     radiation therapy following chemotherapy in treating patients with stage III or stage IV~     Hodgkin's disease.~   "
264623|NCT00088231|"~     The goal of this clinical research study is to find the highest safe doses of PTK 787~     (vatalanib) and Gleevec (imatinib mesylate) that can be given to treat Chronic Myelogenous~     Leukemia-Blastic Phase (CML-BP), Refractory Acute Myelogenous Leukemia (AML), or Agnogenic~     Myeloid Metaplasia (AMM). Another goal is to see how effective this combination treatment is.~   "
264624|NCT00088218|"~     The goal of this clinical research study is to study how effective treatments with~     clofarabine alone and clofarabine given in combination with ara-C are in the treatment of~     leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older.~     The safety of these treatments will also be compared.~   "
264625|NCT00088205|"~     The purposes of this study are to determine the safety of oral enzastaurin HCl and any side~     effects that might be associated with it and whether enzastaurin HCl can help patients with~     Mantle Cell Lymphoma.~   "
275373|NCT00000280|"~     The purpose of this study is to evaluate glutaminergic agents for cocaine abuse.~   "
264627|NCT00087997|"~     The purpose of this study is to evaluate the safety and effectiveness of an experimental~     study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment~     of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States~     since 1992.~   "
264628|NCT00088192|"~     To provide Pegaptanib sodium injection to patients with subfoveal choroidal~     neovascularization (CNV) secondary to AMD, who are unable to participate in any of the~     Sponsor’s other clinical studies with this drug for AMD, until such time as the patient’s~     lesion is considered to have resolved or stabilized in the opinion of the treating~     ophthalmologist, or product becomes commercially available.~   "
264629|NCT00088166|"~     The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone~     (Decadron) a common treatment for symptoms of brain swelling (edema). This study is~     specifically aimed at patients who require chronic high doses of dexamethasone to manage~     symptoms.~   "
264630|NCT00003884|"~     RATIONALE: Zoledronate may help to relieve some of the symptoms caused by bone metastases. It~     is not yet known if zoledronate is more effective than no further therapy in relieving~     symptoms of bone metastases or preventing disease progression.~      PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in treating~     patients who have solid tumors that have spread to the bone.~   "
264631|NCT00003812|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug and giving them before and with radiation therapy may be an~     effective treatment for limited-stage small cell lung cancer.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in~     treating patients who have limited-stage small cell lung cancer.~   "
264632|NCT00003808|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of theophylline in treating patients who~     have in situ, stage I, or stage II chronic lymphocytic leukemia.~   "
264633|NCT00003781|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial of docetaxel in treating patients who have stage IV prostate cancer~     that has not responded to hormone therapy.~   "
264634|NCT00003763|"~     RATIONALE: Diagnostic procedures using the drug radiolabeled folic acid and imaging may be~     effective in detecting ovarian cancer.~      PURPOSE: Diagnostic trial to study the effectiveness of radiolabeled folic acid plus imaging~     in detecting ovarian cancer.~   "
264635|NCT00003748|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have esophageal or stomach cancer.~   "
264636|NCT00003725|"~     RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and~     may have fewer side effects and improve recovery. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die. It is not yet known~     whether transurethral resection plus AD 32 is more effective than transurethral resection~     alone for bladder cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection~     surgery followed by AD 32 with that of transurethral resection alone in treating patients who~     have newly diagnosed or recurrent bladder cancer.~   "
264637|NCT00003677|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients who~     have metastatic pancreatic cancer.~   "
264638|NCT00003675|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Randomized phase II trial to study the effectiveness of topotecan in treating~     patients who have myelodysplastic syndrome.~   "
264639|NCT00003610|"~     RATIONALE: Capsaicin lozenges may be effective treatment for mucositis caused by radiation~     therapy. It is not yet known whether capsaicin lozenges are more effective than no treatment~     for mucositis caused by radiation therapy.~      PURPOSE: Randomized phase III trial to study the effectiveness of capsaicin lozenges in~     treating patients with mucositis caused by radiation therapy.~   "
264640|NCT00003585|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. Combining biological therapy with chemotherapy may~     kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of biological therapy plus chemotherapy~     in treating patients with metastatic or recurrent kidney cancer.~   "
264641|NCT00003557|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with~     metastatic or recurrent liver, bile duct, or gallbladder cancer.~   "
264642|NCT00003392|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose chemotherapy and peripheral~     stem cell transplantation in treating patients with recurrent or refractory metastatic breast~     cancer.~   "
264643|NCT00003391|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of muJ591 monoclonal antibody in treating~     patients who have metastatic prostate cancer that has not responded to hormone therapy.~   "
264644|NCT00003267|"~     RATIONALE: The use of pelvic drains may help to prevent complications following radical~     hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains~     during surgery is more effective than receiving no pelvic drains during surgery in patients~     with uterine, cervical, or vaginal cancer.~      PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following~     radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with~     uterine, cervical, or vaginal cancer.~   "
264647|NCT00088114|"~     The purpose of this study is to determine the safety, toxicity and maximum tolerated dose of~     single doses of STA-4783/paclitaxel in combination when administered intravenously to~     patients with refractory cancer. To determine the pharmacokinetics of STA-4783 and paclitaxel~     when co-administered.~      To assess the anti-tumor activity of STA-4783 and paclitaxel when co-administered.~   "
264648|NCT00088101|"~     The purpose of this study is to determine the safety, toxicity and patient tolerance of~     STA-5312 administered intravenously to patients with relapsed or refractory hematological~     malignancies and patients with solid tumors.~   "
264649|NCT00088088|"~     This study is for patients who have Stage IIIb or Stage IV NSCLC and have never had~     chemotherapy before for their disease. The first phase of the study recently completed and~     for the second phase of the study patients are randomly assigned to receive either paclitaxel~     and carboplatin or paclitaxel and carboplatin and study drug (STA 4783). Treatment will be~     every 3 weeks for 6 cycles.~   "
264650|NCT00088075|"~     A clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of~     risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a~     sugar pill) in adolescents (aged 13 to 17 years) with schizophrenia (i.e. abnormal behavior~     and thoughts). The study duration is about 6 to 7 weeks.~   "
264651|NCT00088062|"~     The purpose of this study is to determine the safety and tolerability of STA-5326 given once~     daily or twice daily to Crohn's Disease patients with moderate disease.~   "
264652|NCT00088049|"~     The purpose of the protocol is to evaluate the efficacy of olanzapine compared with~     Aripiprazole in patients with schizophrenia.~   "
264653|NCT00088036|"~     The purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared~     with placebo in patients with Borderline Personality Disorder (BPD).~   "
264654|NCT00003238|"~     RATIONALE: Drugs used in chemotherapy use different way to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients~     with metastatic prostate cancer that has not responded to hormone therapy with androgens.~   "
264655|NCT00003225|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus irinotecan in~     treating patients with metastatic colorectal cancer.~   "
264656|NCT00088023|"~     The purpose of this study is to determine the safety of a short intravenous infusion of~     PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy~     or for whom no such therapies exist.~   "
264657|NCT00088010|"~     The purpose of this trial is to study:~        -  Effects of arzoxifene on bone fractures and bone mass.~        -  Effects of arzoxifene on getting breast cancer.~        -  Effects of arzoxifene on certain types of cardiovascular events, such as heart attack~          and stroke.~        -  Effects of arzoxifene that changes the amount of certain substances in the blood that~          are related to osteoporosis and cardiovascular health.~        -  Effects of arzoxifene on the uterus.~        -  The safety of arzoxifene and any side effects.~   "
264658|NCT00087984|"~     The purpose of this trial is to examine the safety, feasibility, immunological response, and~     clinical antitumor activity of administering a dendritic cell vaccine to patients with~     metastatic renal cell carcinoma.~   "
264659|NCT00087958|"~     The purpose of this clinical trial is to determine if the investigational drug is able to~     reduce/shrink advanced breast cancer tumors in patients who no longer benefit from~     anthracyclines, taxanes and capecitabine.~   "
264660|NCT00087945|"~     The way abacavir (ABC) behaves in the body differs between children and adults, but little is~     known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for~     adolescents. The purpose of this study is to determine the blood levels of ABC in HIV~     infected adolescents who are on ABC-containing regimens.~   "
264661|NCT00087919|"~     To investigate the genetic basis of obesity by fine mapping an obesity quantitative trail~     linkage (QTL) linked to chromosome 3q.~   "
264662|NCT00087906|"~     To test a conceptual model of how disability develops in chronic obstructive pulmonary~     disease (COPD).~   "
264663|NCT00087893|"~     To investigate the relationship of vascular cell phenotypes to atherosclerosis.~   "
264664|NCT00087880|"~     The purpose of this study is to evaluate the extended pharmacological and psychological~     treatment for chronic cigarette smokers.~   "
264665|NCT00087867|"~     The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in~     relapsed, refractory patients with multiple myeloma (MM), based on response rates.~   "
264666|NCT00005996|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. SU5416 may stop the growth of solid tumors by stopping blood flow~     to the tumor. Combining more than once chemotherapy drug with SU5416 may kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of SU5416 combined with gemcitabine and~     cisplatin in treating patients who have advanced solid tumors.~   "
264667|NCT00005806|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced non-small cell lung cancer.~   "
264668|NCT00005632|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining~     a vaccine with QS21 may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus immune adjuvant~     QS21 in treating patients who have prostate cancer.~   "
264669|NCT00005619|"~     RATIONALE: Diagnostic procedures that detect residual disease may predict disease relapse in~     patients who have hairy cell leukemia.~      PURPOSE: Diagnostic trial to determine the effectiveness of analyzing blood and bone marrow~     to detect residual disease in patients who have previously treated hairy cell leukemia.~   "
264670|NCT00005042|"~     RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the~     tumor.~      PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have~     AIDS-related Kaposi's sarcoma.~   "
267519|NCT00065208|"~     The purpose of this study is to determine whether Reiki energy healing affects anxiety and~     disease progression in patients with localized prostate cancer who are candidates for radical~     prostatectomy.~   "
264671|NCT00005029|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients who have~     recurrent ovarian epithelial or primary peritoneal cancer.~   "
264672|NCT00004199|"~     RATIONALE: Prinomastat may stop the growth of non-small cell lung cancer by stopping blood~     flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop~     growing or die.~      PURPOSE: Randomized phase III trial to determine the effectiveness of prinomastat plus~     cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small~     cell lung cancer.~   "
264673|NCT00004164|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have stage IIB, stage III, or stage IV cancer of the nasopharynx.~   "
264674|NCT00004160|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus radiation therapy~     in treating patients who have stage III non-small cell lung cancer that cannot be surgically~     removed.~   "
264675|NCT00004158|"~     RATIONALE: Radiation therapy using holmium Ho 166 DOTMP may damage cancer cells. Drugs used~     in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy used to kill cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy using holmium Ho~     166 DOTMP plus melphalan and peripheral stem cell transplantation in treating patients who~     have multiple myeloma.~   "
264676|NCT00004104|"~     RATIONALE: Vaccines may make the body build an immune response and kill tumor cells.~     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Interferon~     alfa-2b may interfere with the growth of tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus~     interleukin-2 with or without interferon alfa-2b in treating patients who have stage III~     melanoma.~   "
264677|NCT00004060|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have~     recurrent, metastatic, or unresectable ovarian, fallopian tube, or peritoneal cancer.~   "
264678|NCT00004047|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating patients who have~     hematologic cancer.~   "
264679|NCT00004041|"~     RATIONALE: Inserting the gene for adenovirus p53 into a person's tumor may improve the body's~     ability to fight cancer.~      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who~     have recurrent malignant gliomas.~   "
264680|NCT00003881|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     monoclonal antibody therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab~     plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung~     cancer.~   "
264681|NCT00003219|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients~     with metastatic breast cancer that has not responded to previous chemotherapy.~   "
264682|NCT00003196|"~     This pilot clinical trial studies low-dose total body irradiation and donor peripheral blood~     stem cell transplant followed by donor lymphocyte infusion in treatment patients with~     non-Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma. Giving total-body~     irradiation before a donor peripheral blood stem cell transplant helps stop the growth of~     cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells.~     When healthy stem cells from a donor are infused into the patient they may help the patient's~     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the~     donated stem cells begin working, the patient's immune system may see the remaining cancer~     cells as not belonging in the patient's body and destroy them. Giving an infusion of the~     donor's white blood cells (donor lymphocyte infusion) may boost this effect.~   "
264683|NCT00003171|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with~     myelodysplastic syndrome.~   "
264684|NCT00003082|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibodies in treating~     patients who have advanced cancer.~   "
264685|NCT00003057|"~     RATIONALE: Drugs such as octreotide and loperamide hydrochloride use different ways to~     relieve the diarrhea caused by chemotherapy.~      PURPOSE: Randomized phase III trial to compare the effectiveness of octreotide with~     loperamide hydrochloride for the treatment of chemotherapy-related diarrhea in patients who~     have colorectal cancer.~   "
264686|NCT00002998|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating~     patients with metastatic breast cancer that has not responded to systemic therapy.~   "
264687|NCT00002994|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill solid tumor~     cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Pilot study to examine the effectiveness of interleukin-2 plus monoclonal antibody~     in treating patients who have solid tumors.~   "
275374|NCT00000279|"~     The purpose of this study is to evaluate novel medications for opiate detoxification.~   "
264688|NCT00002956|"~     RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help~     the body kill cancers associated with this virus.~      PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells~     derived from matched donors in organ transplant patients with lymphoproliferative diseases~     associated with Epstein-Barr virus.~   "
264689|NCT00002925|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Some cancers may become resistant to chemotherapy drugs.~     Combining PSC 833 with chemotherapy may reduce resistance to the drugs and allow the cancer~     cells to be killed. Interleukin-2 may stimulate a person's white blood cells to kill leukemia~     cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus PSC 833~     followed by additional chemotherapy or peripheral stem cell transplantation and interleukin-2~     in treating patients with untreated acute myelogenous leukemia.~   "
264690|NCT00002908|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of bryostatin 1 in treating patients who~     have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.~   "
264691|NCT00002907|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with~     relapsed multiple myeloma.~   "
264692|NCT00002862|"~     Phase I trial to study the effectiveness of perillyl alcohol in treating patients with~     refractory cancer. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die.~   "
264693|NCT00002763|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not known~     whether giving high-dose or low-dose interferon alfa is more effective than no further~     therapy in treating patients with stage III melanoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of high- or low-dose~     interferon alfa with that of no further therapy following surgery in treating patients who~     have stage III melanoma.~   "
264694|NCT00002760|"~     RATIONALE: Antiandrogen withdrawal may be an effective treatment for prostate cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of ketoconazole and~     hydrocortisone for antiandrogen withdrawal in treating men with prostate cancer that is~     refractory to hormone therapy.~   "
264695|NCT00002667|"~     RATIONALE: Using new methods to examine sputum samples for the presence of cancer cells may~     detect lung cancer earlier.~      PURPOSE: Screening trial to study the effectiveness of new methods of examining sputum~     samples to detect second primary lung cancer in patients with resected stage I non-small cell~     lung cancer.~   "
264696|NCT00002620|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an~     effective treatment for patients with anaplastic astrocytomas.~      PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in~     treating patients with anaplastic astrocytomas.~   "
264697|NCT00002563|"~     RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help~     determine the intermediate- and long-term effects of treatment on patients with cancer.~      PURPOSE: This clinical trial studies the impact of therapy on the health status and quality~     of life of patients with stage I or stage II Hodgkin's disease who are receiving radiation~     therapy with or without chemotherapy.~   "
264698|NCT00002557|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of etoposide with or without doxorubicin~     and methotrexate in treating patients who have mycosis fungoides.~   "
264699|NCT00002549|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     followed by bone marrow or peripheral stem cell transplantation in treating patients with~     acute myelogenous leukemia.~   "
264700|NCT00002545|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy uses~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy and~     carmustine in treating patients who have supratentorial glioblastoma multiforme.~   "
264701|NCT00002502|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients~     who have acute or chronic leukemia or myelodysplastic syndrome.~   "
264702|NCT00002495|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor~     cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without doxorubicin and vinblastine in treating patients with stage I or stage II Hodgkin's~     disease.~   "
264703|NCT00002465|"~     RATIONALE: Some hormones can stimulate the growth of some types of cancer cells. Hormone~     therapy using megestrol may fight cancer by reducing the production of these hormones.~      PURPOSE: Phase I/II trial to study the effectiveness of high-dose megestrol in treating~     patients with metastatic breast cancer, endometrial cancer, or mesothelioma which cannot be~     treated with surgery or radiation therapy.~   "
264704|NCT00087932|"~     The purpose of this study is to determine whether differences in the use of complementary and~     alternative medicine (CAM) are influenced by the socioeconomic status and ethnicity of cancer~     patients.~   "
264705|NCT00087854|"~     The purpose of this study is to assess the safety and efficacy of Amonafide in men with~     androgen-independent prostate cancer, assigned to individualized doses of Amonafide based on~     acetylator phenotype information (doses adjusted on individual metabolism).~   "
264708|NCT00087815|"~     RATIONALE: Hyperbaric oxygen may increase blood flow and decrease swelling in areas of the~     brain damaged by radiation therapy. Giving hyperbaric oxygen therapy together with~     dexamethasone may be an effective treatment for radiation necrosis of the brain.~      PURPOSE: This randomized clinical trial is studying how well hyperbaric oxygen therapy works~     in treating patients with radiation necrosis of the brain.~   "
264709|NCT00087802|"~     The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin~     (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response~     and safety between the two drug combinations for the treatment of advanced non-small cell~     lung cancer (NSCLC).~   "
264710|NCT00087789|"~     This is a Phase I clinical study to assess the safety, tolerability and biologic activity of~     in vivo AAV-mediated delivery of CERE-110. Up to 12 subjects will receive open label CERE-110~     in dose-escalating fashion. All subjects will receive bilateral, stereotactic injections of~     CERE-110 for a total of four (Dose A and B) and six (Dose C) injections to target the basal~     forebrain region of the brain containing the nucleus basalis of Meynert (NBM). All study~     participants will be observed for a 24-month period and then followed annually.~   "
264711|NCT00087776|"~     The primary objective of this trial is to compare the survival of patients with metastatic~     malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In~     addition, the response rate to each drug, response duration, time to progression and time to~     treatment failure will be measured. Toxicity will be evaluated and compared between the two~     groups.~   "
264712|NCT00087763|"~     The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves~     vision in patients with wet AMD.~   "
264713|NCT00087750|"~     The purpose of this study is to assess the safety of intravenous (IV) cocaine in subjects~     taking quetiapine at 3 dosage levels.~   "
264714|NCT00087737|"~     To compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult~     outpatients with MDD.~   "
264715|NCT00087711|"~     This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to~     gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC).~     Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that~     pemetrexed plus cisplatin may be as effective and may have fewer side effects than the~     standard of care.~   "
264716|NCT00087698|"~     This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus~     cisplatin before surgery is at killing all the tumor so that none is left at the time of~     surgery. Following surgery, all eligible patients will receive radiation to the chest. How~     patients respond, whether the cancer returns and if so, where, will also be monitored.~   "
264717|NCT00082511|"~     Open label safety and efficacy follow-up.~   "
264718|NCT00003877|"~     RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of~     chemotherapy and kill more tumor cells. It is not yet known whether Stromagen improves the~     success of stem cell transplantation in women with breast cancer.~      PURPOSE: Randomized phase I/II trial to study the effectiveness of Stromagen during stem cell~     transplantation following chemotherapy in treating women with metastatic breast cancer.~   "
264719|NCT00003874|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in~     treating patients who have lymphoma or leukemia.~   "
264720|NCT00003873|"~     Randomized phase III trial to compare the effectiveness of fluorouracil given by infusion~     with that of fluorouracil plus eniluracil given by mouth in treating patients who have~     metastatic, recurrent, or residual advanced colorectal cancer. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. It is not yet~     known if fluorouracil is more effective with or without eniluracil for advanced colorectal~     cancer~   "
264721|NCT00003853|"~     RATIONALE: 4'-Iodo-4'-deoxydoxorubicin may improve organ dysfunction and ease symptoms caused~     by primary systemic amyloidosis.~      PURPOSE: Phase II trial to study the effectiveness of 4'-iodo-4'-deoxydoxorubicin in treating~     patients who have primary systemic amyloidosis.~   "
264722|NCT00003805|"~     RATIONALE: Antibiotic therapy may prevent the development of infection in patients with~     hematologic cancer and the persistent fever caused by a low white blood cell count. It is not~     yet known which regimen of antibiotics is most effective in preventing infection in these~     patients.~      PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam~     with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or~     Hodgkin's disease.~   "
264723|NCT00003804|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known which regimen of chemotherapy is more~     effective for stage I Wilms' tumor.~      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and surgery in~     treating children who are at risk of or who have stage I Wilms' tumor.~   "
264724|NCT00003792|"~     RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the~     body build an immune response and kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have metastatic melanoma.~   "
264725|NCT00003743|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill neuroblastoma~     cells.~      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating children with~     stage IV neuroblastoma who have received induction therapy and peripheral stem cell~     transplantation.~   "
264726|NCT00003664|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill~     kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining~     chemotherapy with biological therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and biological~     therapy in treating patients with kidney cancer that is metastatic or cannot be removed~     surgically.~   "
264779|NCT00087074|"~     This phase II trial is studying how well CCI-779 works in treating patients with soft tissue~     sarcoma or gastrointestinal stromal tumor. Drugs used in chemotherapy, such as CCI-779, work~     in different ways to stop tumor cells from dividing so they stop growing or die.~   "
264727|NCT00003639|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells~     and slow the growth of non-Hodgkin's lymphoma. It is not yet known whether combining more~     than one chemotherapy drug with interferon alfa is more effective than chemotherapy alone in~     treating patients with low-grade non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without interferon alfa in treating patients with low-grade non-Hodgkin's lymphoma.~   "
264728|NCT00003604|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer~     cells.~      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with~     stage III or stage IV kidney cancer that has been removed by surgery.~   "
264729|NCT00003359|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of T138067 sodium in treating patients with~     advanced refractory cancer.~   "
264730|NCT00003343|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether mitoxantrone and prednisone are more~     effective with or without prinomastat in treating patients with metastatic prostate cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of mitoxantrone and~     prednisone with or without prinomastat in treating patients who have metastatic prostate~     cancer that has not responded to hormone therapy.~   "
264731|NCT00003328|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether radiation therapy followed by porfiromycin is more effective~     than radiation therapy alone in treating patients with head and neck cancer.~      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of~     radiation therapy followed by porfiromycin in treating patients with stage III or stage IV~     head and neck cancer.~   "
264732|NCT00087724|"~     The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels~     of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease.~     Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.~   "
264733|NCT00087685|"~     The goal of this clinical research study is to learn if RAD001 can shrink or slow the growth~     of tumors in patients who have recurrent endometrial cancer. The safety of this drug will~     also be studied.~      Objectives:~      Primary Objective:~      1. To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial~     cancer.~      Secondary Objective:~        1. To determine the nature and degree of toxicity of RAD001 in this cohort of patients.~        2. To characterize, in pre- and post- treatment tumor samples, when available, expression~          levels of total and phosphorylated mTOR (mammalian target of rapamycin) as well as~          relevant upstream and downstream signaling components (optional).~   "
264734|NCT00087672|"~     The goal of this clinical research study is to learn if CC-5013 (lenalidomide) can help to~     control myelofibrosis. The safety of lenalidomide in the treatment of myelofibrosis will also~     be studied.~   "
264735|NCT00087659|"~     This study is being conducted to compare the effect of an investigational drug versus placebo~     on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy~     (ADT). The study drug or placebo will be administered every three months of four treatments~     in one year.~      In order to participate, male patients 18 years and older must be consecutive veterans from~     participating Veterans Administration Medical Centers.~   "
264736|NCT00087646|"~     This 4 arm study is designed for patients with CHC who have not responded to peginterferon~     alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening~     the duration of treatment, as well as including an initial 12-week period of high-dose~     PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS~     (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment~     is 1-2 years and the target sample size is 500+ individuals.~   "
264737|NCT00087633|"~     This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of~     prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to~     initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection.~     The anticipated time on study treatment was 3-12 months, and the target sample size was~     100-500 individuals.~   "
264738|NCT00087620|"~     To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2~     twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily)~     until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W).~   "
264739|NCT00087607|"~     This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and~     PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on~     study treatment is 3-12 months, and the target sample size is 100-500 individuals.~   "
264740|NCT00087594|"~     This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous~     intravenous (iv) drug users who have CHC and are currently enrolled in a methadone~     maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the~     target sample size is <100 individuals.~   "
264741|NCT00087581|"~     This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF~     combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or~     tacrolimus, in participants who have undergone kidney transplantation. Participants will be~     randomized to one of three dosing regimens to receive concentration-controlled MMF with~     reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard~     CNI. Participants will be followed for 20-24 months after randomization.~   "
264742|NCT00087568|"~     This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in~     patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with~     PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the~     target sample size is >100 individuals.~   "
264743|NCT00087555|"~     The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when~     used alone to treat the pain and sleep disturbances of fibromyalgia.~   "
275375|NCT00000278|"~     The purpose of this study is to evaluate disulfiram for cocaine-alcohol abuse.~   "
264744|NCT00087542|"~     The primary objective is to demonstrate that the investigational new drug, ACP-103, is well~     tolerated by, and will not worsen parkinsonism in, patients with Parkinson's disease and~     psychosis. The secondary objectives are to determine whether ACP-103 will ameliorate~     psychosis in patients with Parkinson's disease and whether ACP-103 is safe in Parkinson's~     disease patients taking multiple anti-parkinsonian medications.~   "
264745|NCT00087529|"~     This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled,~     multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The~     study will enroll approximately 435 subjects at up to 60 sites in the United States and~     Canada.~   "
264746|NCT00087516|"~     The purpose of this clinical study is to determine the safety and efficacy of an~     investigational drug in patients with type 2 diabetes mellitus.~   "
264747|NCT00087503|"~     This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult~     patients with advanced gastric cancer, reasonable performance status, good organ function,~     lack of serious concomitant medical conditions. Patients must have progressed or recurred~     after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or~     within 6 months of last dose of adjuvant therapy. Twenty-one evaluable patients will be~     enrolled in Stage 1. If at least 2 objective tumor responses are observed in the first 21~     evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients.~     Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60~     minutes in repeated 3-week cycles treatment.~   "
264748|NCT00087490|"~     To determine if linezolid is superior to vancomycin in the treatment of complicated skin and~     soft tissue infections due to MRSA in adult subjects~   "
264749|NCT00087477|"~     This pilot study will assess the safety and efficacy of Pivanex alone in patients with~     malignant melanoma who have relapsed after treatment with chemotherapy or Interleukin-2~     (IL-2). Pivanex is an investigational agent.~   "
264750|NCT00087464|"~     Short-term therapy may reduce the amount of HIV in the blood of adults recently infected with~     HIV. The purpose of this study is to see whether it is better for people to take a short~     course of anti-HIV drugs when they are first infected or if it is better to wait until the~     HIV infection causes health problems before taking anti-HIV drugs.~   "
264751|NCT00087451|"~     A Phase I, open-label, non-randomized, sequential dose escalation cohort trial of the safety,~     tolerability, and maximum tolerated dose (MTD) of AP23573 when administered intravenously as~     a 30-minute infusion, once daily for five days, repeated every two weeks, to patients with~     progressive or recurrent malignant glioma.~   "
264752|NCT00086710|"~     A total of 26 patients will be admitted to the clinic where they will be dosed with each~     injection device. There will be a 7-day washout between doses and a 7-10 day follow-up~     period.~   "
264753|NCT00086645|"~     This study will determine the efficacy and safety of citalopram compared to placebo in the~     treatment of children with autism.~   "
264754|NCT00003589|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective in treating advanced~     non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of three different~     combination chemotherapy regimens in treating patients who have advanced non-small cell lung~     cancer.~   "
264755|NCT00087438|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body~     radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage~     to normal tissue.~      PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works~     in treating patients with inoperable stage I or stage II non-small cell lung cancer.~   "
264756|NCT00087425|"~     RATIONALE: Drugs used in chemotherapy, such as bryostatin 1, work in different ways to stop~     cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as~     rituximab can locate cancer cells and either kill them or deliver cancer-killing substances~     to them without harming normal cells. Bryostatin 1 may help rituximab kill more cancer cells~     by making them more sensitive to the drug.~      PURPOSE: This phase II trial is studying how well giving bryostatin 1 together with rituximab~     works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia~     that has not responded to previous treatment with rituximab.~   "
264757|NCT00087412|"~     This phase II trial is studying how well erlotinib works in treating patients with advanced~     primary non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking~     the enzymes necessary for their growth~   "
264758|NCT00087399|"~     RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast~     cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet~     known whether gabapentin is more effective with or without antidepressants in treating hot~     flashes.~      PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see~     how well they work compared to antidepressants alone in treating hot flashes in women who~     have had breast cancer or who have concerns about taking hormones to treat hot flashes.~   "
264759|NCT00087386|"~     This phase II trial is studying how well tanespimycin works in treating patients with stage~     III or stage IV melanoma. Antitumor antibiotics such as tanespimycin may stop the growth of~     melanoma by stopping blood flow to the tumor.~   "
264760|NCT00087373|"~     Vaccines may make the body build an immune response to kill tumor cells. Injecting a vaccine~     directly into a tumor may cause a stronger immune response and kill more tumor cells. This~     phase II trial is studying how well vaccine therapy works in treating patients with~     metastatic melanoma.~   "
264761|NCT00087360|"~     RATIONALE: Evaluating the knowledge and attitudes of healthy participants toward a new diet~     and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal~     cancer screening.~      PURPOSE: This clinical trial is studying the knowledge and attitudes of healthy participants~     toward genetic and environmental risk assessment for colorectal cancer.~   "
264762|NCT00087347|"~     RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) using ferumoxytol~     may improve the ability to detect cancer that has spread to the lymph nodes and may help plan~     effective cancer treatment.~      PURPOSE: This clinical trial is studying how well MRI using ferumoxytol works in detecting~     metastases to the lymph nodes in patients with primary prostate cancer or primary breast~     cancer.~   "
264763|NCT00087334|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may~     stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining~     capecitabine and oxaliplatin with gefitinib may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine~     when given together with oxaliplatin and gefitinib and to see how well they work in treating~     patients with metastatic colorectal cancer.~   "
264764|NCT00087295|"~     RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different~     ways to stop tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with~     advanced cancer of the urothelium that has progressed or recurred after receiving one~     chemotherapy regimen.~   "
264765|NCT00087282|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and flavopiridol, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one~     drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with~     flavopiridol works in treating patients with advanced liver cancer.~   "
264766|NCT00087269|"~     This phase II trial is studying how well erlotinib works in treating patients with stage I,~     stage II, or stage IIIA non-small cell lung cancer. Erlotinib may stop the growth of tumor~     cells by blocking the enzymes necessary for their growth. Giving erlotinib before surgery may~     shrink the tumor so that it can be removed.~   "
264767|NCT00087256|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. It is not yet known whether celecoxib is effective in preventing~     polyps in patients with colon cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of celecoxib in preventing the~     development of polyps in patients who have undergone surgery for stage I colon cancer.~   "
264768|NCT00087217|"~     This phase I trial is studying the side effects and best dose of~     17-N-allylamino-17-demethoxygeldanamycin when given together with paclitaxel in treating~     patients with metastatic or unresectable solid tumor. Drugs used in chemotherapy, such as~     17-N-allylamino-17-demethoxygeldanamycin and paclitaxel, work in different ways to stop tumor~     cells from dividing so they stop growing or die. Combining~     17-N-allylamino-17-demethoxygeldanamycin with paclitaxel may kill more tumor cells~   "
264769|NCT00087204|"~     This phase I trial is studying the side effects and best dose of rebeccamycin analog in~     treating patients with relapsed or refractory acute myeloid leukemia, myelodysplastic~     syndrome, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blast phase. Drugs~     used in chemotherapy, such as rebeccamycin analog, work in different ways to stop cancer~     cells from dividing so they stop growing or die~   "
264770|NCT00087191|"~     This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor~     cells and/or normal tissues of patients with abdominal (such as ovarian, colon, or stomach~     cancer) or non-small cell lung cancer. EF5 may be effective in measuring oxygen in tumor~     tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and,~     when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in~     tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may~     help predict the effectiveness of anticancer therapy~   "
264771|NCT00087178|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide,~     and doxorubicin, work in different ways to stop tumor cells from dividing so they stop~     growing or die. It is not yet known which combination chemotherapy regimen is more effective~     in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to~     compare how well they work in treating women who have undergone surgery for breast cancer~     that has not spread to the lymph nodes.~   "
264772|NCT00087165|"~     RATIONALE: GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. GTI-2040 may help docetaxel kill more~     tumor cells by making them more sensitive to the drug.~      PURPOSE: This phase II trial is studying how well giving GTI-2040 together with docetaxel and~     prednisone works in treating patients with prostate cancer that has not responded to hormone~     therapy.~   "
264773|NCT00087152|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes~     necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     imatinib mesylate with capecitabine may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with~     capecitabine works in treating women with progressive stage IV breast cancer.~   "
264774|NCT00087139|"~     Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells~     from dividing so they stop growing or die. This phase II trial is studying how well~     ixabepilone works in treating patients with metastatic prostate cancer that has not responded~     to previous hormone therapy.~   "
264775|NCT00087126|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well topotecan works in treating women with~     persistent or recurrent cervical cancer.~   "
264776|NCT00087113|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to~     stop tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating~     patients with recurrent cancer of the cervix.~   "
264777|NCT00087100|"~     RATIONALE: Drugs used in chemotherapy such as pemetrexed disodium work in different ways to~     stop tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating~     patients with persistent or recurrent endometrial cancer.~   "
264778|NCT00087087|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to~     stop tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating~     patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.~   "
275376|NCT00000277|"~     The purpose of this study is to evaluate high and low dose mazindol for cocaine abuse.~   "
264780|NCT00087061|"~     RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in~     treating patients with recurrent or progressive primary malignant glioma.~   "
264781|NCT00087048|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line~     therapy in treating patients with recurrent extensive-stage small cell lung cancer.~   "
264782|NCT00087035|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor~     cells by blocking the enzymes necessary for their growth. Combining docetaxel with erlotinib~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with erlotinib~     works in treating older patients with progressive prostate cancer that has not responded to~     hormone therapy.~   "
264783|NCT00087022|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. It is not yet known whether~     monoclonal antibody therapy is effective in treating kidney cancer.~      PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how~     well it works in treating patients who have undergone surgery for nonmetastatic primary~     kidney cancer.~   "
264784|NCT00087009|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Beta-glucan~     may increase the effectiveness of rituximab by making cancer cells more sensitive to the~     monoclonal antibody.~      PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when~     given together with rituximab in treating young patients with relapsed or progressive~     lymphoma or leukemia or with lymphoproliferative disorder related to donor stem cell~     transplantation.~   "
264785|NCT00086996|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make~     tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving~     chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be~     removed.~      PURPOSE: This phase II trial is studying how well giving oxaliplatin together with~     fluorouracil and radiation therapy works in treating patients who are undergoing surgery for~     stage II or stage III cancer of the esophagus or gastroesophageal junction.~   "
264786|NCT00086983|"~     This phase I trial is studying the side effects and best dose of rebeccamycin analog and~     oxaliplatin in treating patients with refractory solid tumors. Drugs used in chemotherapy,~     such as rebeccamycin analog and oxaliplatin, work in different ways to stop tumor cells from~     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells~   "
264787|NCT00086970|"~     This randomized phase I trial is studying the side effects and best dose of~     O(6)-benzylguanine when given together with ifosfamide and to see how well it works compared~     to ifosfamide alone in treating patients with unresectable metastatic solid tumors. Drugs~     used in chemotherapy, such as ifosfamide and O(6)-benzylguanine, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Combining ifosfamide with~     O(6)-benzylguanine may kill more tumor cells~   "
264788|NCT00086957|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and either~     kill them or deliver tumor-killing substances to them without harming normal cells. Drugs~     used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from~     dividing so they stop growing or die. Combining gefitinib and trastuzumab with docetaxel may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the best dose of docetaxel when given together~     with gefitinib and trastuzumab in treating patients with metastatic breast cancer.~   "
264789|NCT00086944|"~     This phase I/II trial is studying the side effects and best dose of oblimersen when given~     together with rituximab and combination chemotherapy and to see how well they work in~     treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Monoclonal~     antibodies such as rituximab can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy,~     such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells~     from dividing so they stop growing or die. Oblimersen may increase the effectiveness of~     chemotherapy by making cancer cells more sensitive to the drugs~   "
264790|NCT00086931|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and capecitabine may make~     tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving~     chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be~     removed.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and~     capecitabine when given together with radiation therapy and to see how well they work in~     treating patients who are undergoing surgery for locally advanced cancer of the rectum. NOTE:~     *The phase I portion of this trial closed 06/2005. The best dose of oxaliplatin and~     capecitabine has been determined.~   "
264791|NCT00086892|"~     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so~     they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin~     works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal~     cancer.~   "
264820|NCT00003091|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may~     stimulate a person's white blood cells to kill kidney cancer or melanoma cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose interferon alfa and~     interleukin-2 in treating patients with metastatic kidney cancer or melanoma.~   "
264792|NCT00086879|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. It is not yet~     known whether erlotinib is more effective than temozolomide or carmustine in treating~     recurrent glioblastoma multiforme.~      PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works~     compared to temozolomide or carmustine in treating patients with recurrent glioblastoma~     multiforme.~   "
264793|NCT00086866|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy~     and comparing them to see how well they work in treating patients with stage III or stage IV~     melanoma that cannot be removed with surgery.~   "
264794|NCT00086840|"~     This phase II trial is studying how well CCI-779 works in treating patients with relapsed or~     refractory chronic lymphocytic leukemia. Drugs used in chemotherapy, such as CCI-779, work in~     different ways to stop cancer cells from dividing so they stop growing or die~   "
264795|NCT00086827|"~     This phase II trial is studying how well FR901228 works in treating patients with recurrent~     small cell lung cancer. FR901228 may stop the growth of tumor cells by blocking the enzymes~     necessary for their growth.~   "
264796|NCT00086801|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine,~     work in different ways to stop cancer cells from dividing so they stop growing or die.~     Combining more than one drug may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.~   "
264797|NCT00086775|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop~     cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as~     alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Combining chemotherapy with~     monoclonal antibody therapy may kill more cancer cells. It is not yet known whether~     fludarabine is more effective when combined with alemtuzumab or with rituximab in treating~     chronic lymphocytic leukemia.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with~     either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell~     chronic lymphocytic leukemia.~   "
264798|NCT00086762|"~     RATIONALE: Mindfulness relaxation, a technique to help patients quiet their thoughts and~     relax their bodies before and during chemotherapy, may reduce or prevent nausea and vomiting.~     It may also help improve mental health, quality of life, and immune function in patients~     receiving chemotherapy.~      PURPOSE: This randomized clinical trial is studying mindfulness relaxation to see how well it~     works compared to relaxing music or standard symptom management education in treating~     patients who are receiving chemotherapy for newly diagnosed solid tumors.~   "
264799|NCT00086749|"~     RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased~     risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by~     decreasing estrogen levels.~      PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density~     in premenopausal women with breast cancer or at high risk of developing breast cancer.~   "
264800|NCT00086736|"~     RATIONALE: Drugs used in chemotherapy, such as eflornithine, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of~     prostate cancer cells. Drugs used in hormone therapy, such as bicalutamide, may fight~     prostate cancer by stopping the adrenal glands from producing androgens. Combining~     eflornithine with bicalutamide may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of neoadjuvant eflornithine~     and bicalutamide with that of eflornithine alone, bicalutamide alone, and no neoadjuvant~     therapy in treating patients who are undergoing brachytherapy or radical prostatectomy for~     localized prostate cancer.~   "
264801|NCT00086723|"~     RATIONALE: Tissue plasminogen activator and captopril may help the body generate angiostatin.~     Angiostatin may stop the growth of cancer by stopping blood flow to the tumor.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of tissue~     plasminogen activator and captopril and to see how well they work in treating patients with~     progressive metastatic cancer.~   "
264802|NCT00086684|"~     The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate~     sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo~     for 24 weeks for the relief of bladder pain or discomfort associated with interstitial~     cystitis.~   "
264803|NCT00086671|"~     The objective of the trial is to study the safety and effectiveness of ABT-874 administered~     weekly or every other week in patients with relapsing remitting and secondary progressive~     multiple sclerosis as compared to placebo. Effectiveness will be measured based on MRI scans~     done periodically throughout the study.~   "
264804|NCT00086658|"~     Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms~     which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells,~     various end-organ damages (including skin, heart, lung, nervous system and digestive system~     etc.), and with exclusion of known secondary causes of hypereosinophilia.~      HES has a high morbidity/mortality rate. The major treatment of HES has been systemic~     corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon)~     with the intention to lower eosinophil counts and therefore to slow down the progression of~     disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia~     in some patients, some may eventually become nonresponsive and intolerable to the amount of~     side effects of the long-term therapy with these medications.~      Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5~     (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective~     in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES~     clinical signs and symptoms. This study intends to further evaluate the~     corticosteroid-sparing and clinical benefit of mepolizumab in HES.~   "
264821|NCT00002953|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and~     cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast~     cancer.~   "
264805|NCT00086632|"~     An experimental treatment with OvaRex® MAb-B43.13 (oregovomab), called immunotherapy is being~     tested in ovarian cancer patients. Immunotherapy causes the body's defenses to react against~     cancer cells. The purpose of this research study is to determine if immunotherapy with~     oregovomab can create an immune response and enable the body to fight the disease and help~     ovarian cancer patients live longer. Patients with a possible diagnosis of ovarian cancer~     will be screened for study participation pre-surgery and, if eligible, will receive~     oregovomab during front-line chemotherapy treatment for ovarian cancer and quarterly for~     about a year following chemotherapy. Patients who experience disease progression will be~     discontinued from oregovomab therapy. Patients will also have urine, blood and tissue samples~     collected to assess the immune response to oregovomab.~   "
264806|NCT00086606|"~     This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of~     approximately 150 patients who have a history of immediate hypersensitivity reaction to~     peanut protein.~   "
264807|NCT00086619|"~     Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone~     strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment~     increases bone formation less and less over time. This study will test whether increasing the~     daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies~     will test several potential reasons why PTH's effects on bone formation decline over time.~   "
264808|NCT00086593|"~     This is a 12-week study for the treatment of chronic persistent symptoms in participants with~     schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics~     who fulfill the screening criteria will be randomized to receive either an FDA-approved drug~     or placebo in addition to the current treatment. Safety will be closely monitored through~     vital signs, various tests, and blood and urine samples.~   "
264809|NCT00086580|"~     This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to~     evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus~     fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell~     chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the~     informed consent document may be entered on the study.~   "
264810|NCT00003297|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian~     cancer that has not recurred or that has not responded to previous chemotherapy.~   "
264811|NCT00003296|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating~     patients with liver or bile duct cancer.~   "
264812|NCT00003230|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel in treating patients with~     refractory or recurrent acute leukemia or chronic myelogenous leukemia.~   "
264813|NCT00003198|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy with ifosfamide and~     topotecan in treating patients with refractory solid tumors.~   "
264814|NCT00003109|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus raltitrexed in treating~     patients who have refractory solid tumors that have not responded to previous therapy.~   "
264815|NCT00086541|"~     This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of~     two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily~     for 48 weeks and no treatment in patients chronically infected with hepatitis C who are~     nonresponders to previous pegylated interferon alfa plus ribavirin therapy.~      Patients are randomized 1:1:1 to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both~     administered daily) or no treatment for up to 48 weeks.~      The protocol and informed consent form that will be used must be approved by the~     Investigator’s Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the~     study is initiated.~   "
264816|NCT00086528|"~     The primary objective of this study is as follows:~        -  To evaluate the safety and tolerability of XL647 administered orally as a single dose~          and as repeat doses in subjects with solid tumors.~      The secondary objectives of this study are as follows:~        -  To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose~          and as repeat doses in subjects with solid tumors,~        -  To estimate renal elimination of XL647 administered orally as a single dose in subjects~          with solid tumors.~      The exploratory objective of this study is as follows:~        -  To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral~          blood cells.~      In addition, subjects may be eligible to enter a Treatment Extension Period. The following~     information will be obtained from this part of the study:~        -  Long-term safety and tolerability of XL647 after repeat administration,~        -  Tumor response after repeat administration of XL647.~   "
264817|NCT00086411|"~     The purpose of this study was to compare two different types of Food and Drug Administration~     (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in~     conjunction with two levels of counseling. It was hypothesized that the higher level of~     counseling would have the highest rates of treatment completion and highest rates of~     abstinence.~   "
264818|NCT00086398|"~     The purpose of this study is to evaluate the efficacy of Dual Focus Schema Therapy in~     comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy~     enhancements to the orientation/early treatment process of Therapeutic Community (TC)~     residents.~   "
264819|NCT00086385|"~     The purpose of this study was to examine pharmacological and psychological interventions for~     smokers over 50.~   "
267547|NCT00064857|"~     The goal of this study is to evaluate the effectiveness of a standardized botanical extract~     of Pycnogenol as a treatment for stable arm lymphedema in breast cancer survivors.~   "
264822|NCT00002922|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with~     recurrent or metastatic head and neck cancer.~   "
264823|NCT00002863|"~     RATIONALE: Cryosurgery kills cancer cells by freezing them. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     cryosurgery with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of cryosurgery with or without chemotherapy~     in treating patients who have soft tissue sarcoma.~   "
264824|NCT00086567|"~     This study will develop a blood test that can be used to predict a relapse of ovarian,~     peritoneal, or fallopian tube cancer. The type of testing is called proteomics, or the study~     of proteins in living cells. The test will identify certain proteins that might represent a~     pattern, or fingerprint, indicating increased risk of disease relapse.~      Women with Stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian~     tube cancer that is in remission may be eligible for this study. Candidates are screened with~     a medical history and physical examination, blood tests, review of pathology report from~     surgery, and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the~     abdomen and pelvis (and chest if the cancer spread to the chest).~      Participants have a clinic visit every 3 months for a physical examination (including a~     pelvic examination), blood draw for routine and research tests, and review of how they have~     been feeling. Every 6 months they have CT scans of the abdomen, pelvis, and possibly the~     chest. When a patient has been in remission for 4 years, blood draws are done every 6 months~     and CT scans are done yearly. Patients whose cancer returns (based on a CA-125 blood test, CT~     scans, or physical examination) end their participation in the study. Patients with an~     abnormal CT scan or physical examination may be asked to undergo a tumor biopsy (surgical~     removal of a piece of tumor tissue) for research purposes.~   "
264825|NCT00086554|"~     This study will collect tissue specimens to be used for research on inflammatory bowel~     disease. The tissues will be used to explore why people get inflammatory bowel disease and to~     try to develop new treatments based on the study results. Tissue from patients with IBD will~     be compared with that from patients who do not have the disease~      Patients who undergo bowel surgery for inflammatory bowel disease (IBD) or another bowel~     disorder may be eligible for this study. Patients with IBD must be at least 4 years of age;~     those with another disorder must be 18 years of age or older.~      Participants undergo bowel surgery for their disease. Some of the intestinal tissue removed~     during the surgery that is not needed for medical care, such as for pathological examination,~     is provided to researchers for study under this protocol. In addition, patients with IBD~     provide a blood sample for genetic testing. Several genetic variations, or mutations, may~     increase the risk of developing IBD; blood samples from patients may help identify these~     variations.~   "
264826|NCT00086515|"~     The purpose of this study is to determine the safety and efficacy of an investigational drug~     in patients with type 2 diabetes mellitus.~   "
264827|NCT00086502|"~     The purpose of this study is to determine the safety and efficacy of an investigational drug~     in patients with type 2 diabetes mellitus.~   "
264828|NCT00086489|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal~     antibody therapy using 2 regimens for the treatment of advanced melanoma~   "
264829|NCT00086463|"~     The purpose of this study is to determine the safety and efficacy of Iloprost in subjects~     that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).~   "
264830|NCT00086450|"~     The purpose of this study is to compare 5-year mortality rates in diabetic individuals with~     multivessel coronary artery disease (CAD) who undergo either coronary artery bypass grafting~     (CABG) surgery or percutaneous coronary stenting.~   "
264831|NCT00086437|"~     To study the effect of genes on lipid-lowering drug treatment in hypertriglyceridemia.~   "
264832|NCT00086424|"~     To explore the role of insulin growth factor in cardiovascular disease in older men and~     women.~   "
264833|NCT00002999|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug and combining chemotherapy with radiation therapy may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in~     treating patients with advanced cancer of the nasopharynx.~   "
264834|NCT00086476|"~     Congenital bleeding disorders characterized by abnormal platelet granules include Gray~     Platelet syndrome (GPS; defective alpha-granules), Hermansky-Pudlak syndrome (HPS; defective~     delta-granules), and combined alpha delta-storage pool deficiency (alpha delta-SPD). Other~     diseases associated with variable defects in platelet gamma-granules include Chediak-Higashi,~     Griscelli, Wiskott-Aldrich, and Thrombocytopenia Absent Radius syndromes. These disorders are~     models for the study of organelle formation in megakaryocytes and platelets. Characteristics~     of megakaryocytopoiesis in these disorders have not been investigated because megakaryocytes~     could not be cultured from patients in sufficient quantities for experimental purposes.~     Recent advances have made it possible to culture megakaryocytes using serum-free media~     supplemented with recombinant human thrombopoietin (TPO). Such cultured human megakaryocytes,~     amplified from bone marrow-derived CD34+ stem cells, synthesize and store organellar proteins~     and produce functional platelets. In this protocol, we plan to obtain bone marrow aspirates~     from 40 children and adults (ages 2 to 80 years) with GPS, HPS, and related disorders.~     Patients admitted to the NIH Clinical Center on specific disease-related protocols will be~     enrolled in this protocol during their routine 3-5 day visits. We will culture megakaryocytes~     from CD34+ stem cells isolated from bone marrow aspirates. Studies of cultured megakaryocytes~     will include evaluation of granule membrane and soluble proteins using fluorescent antibodies~     and immunoelectron microscopy and comparison of RNA and protein expression patterns between~     normal and patient cells. Precautions will be taken to prevent the primary risk of the bone~     marrow aspiration, i.e., prolonged bleeding at the aspiration site. Standard diagnostic~     studies on the bone marrow sample may reveal information that may directly benefit patients.~     However, the broader benefit of this study is the acquisition of a better understanding of~     the characteristics of functional platelet disorders and the process of intracellular vesicle~     formation.~   "
264835|NCT00086346|"~     The purpose of this study is to evaluate the sirolimus conversion regimen as compared with~     the calcineurin inhibitor continuation regimen with regards to renal function in stable liver~     transplant subjects.~   "
264836|NCT00086333|"~     This is an open-label, randomized phase II trial of a monoclonal antibody (mAb) drug~     immunoconjugate, SGN-15, administered weekly in combination with weekly docetaxel. The~     primary objective of the study is to determine the optimal interval between SGN-15 and~     docetaxel using FDG-PET imaging as a surrogate marker of response. In addition, clinical~     response rate, duration of response, and survival data will be collected.~   "
275377|NCT00000276|"~     The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.~   "
264838|NCT00086359|"~     Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the~     risk of passing HIV to their infants. This study will compare how well two different~     combinations of anti-HIV medications control HIV in pregnancy, and whether these combinations~     of drugs are effective in preventing HIV from being transmitted from a pregnant woman to her~     baby. The two combinations are abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) and~     zidovudine/lamivudine (ZDV/3TC) plus lopinavir/ritonavir (LPV/RTV).~   "
264839|NCT00086320|"~     The purpose of this study is to determine the efficacy (effectiveness) and safety of~     paliperidone ER compared with placebo in the prevention of recurrence of symptoms of~     schizophrenia.~   "
264840|NCT00086281|"~     To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the~     morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and~     outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea~     syndrome (OSAS).~   "
264841|NCT00086268|"~     This study will evaluate the effects of an investigational drug in combination with~     chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will~     measure the effects of this combination on progression of lung cancer, cancer response to~     treatments, and development of cancer-related bone lesions.~   "
264842|NCT00002837|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining peripheral stem cell transplantation with chemotherapy~     may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy~     and peripheral stem cell transplantation in treating patients with recurrent or metastatic~     breast cancer.~   "
264843|NCT00002804|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, surgery, and~     radiation therapy in treating children who have advanced soft tissue sarcoma.~   "
264844|NCT00002751|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in~     treating patients who have brain metastases.~   "
264845|NCT00002733|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Combining different types of biological therapies, including~     interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, may kill more cancer~     cells.~      PURPOSE: Phase II trial to study the effectiveness of biological therapies, including~     interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, in treating patients with~     metastatic cancer.~   "
264846|NCT00002705|"~     Phase I trial to study the effectiveness of topotecan in treating children with refractory~     leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so~     they stop growing or die.~   "
264847|NCT00002704|"~     Phase II trial to study the effectiveness of radiation therapy following chemotherapy in~     treating children with CNS relapse from acute lymphoblastic leukemia. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining chemotherapy with radiation therapy may kill more cancer cells.~   "
264848|NCT00002691|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and using drugs in different ways may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     pediatric patients with stage III or stage IV non-Hodgkin's lymphoma.~   "
264849|NCT00002654|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known if radiation therapy plus chemotherapy is more effective than~     radiation therapy alone in treating patients with advanced head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus~     cisplatin with radiation therapy alone in treating patients with advanced head and neck~     cancer.~   "
264850|NCT00086307|"~     This study compares the effectiveness of the combination of antidepressants: Lexapro and~     Pramipexole, with the effectiveness of each antidepressant alone.~      Purpose: Patients between 18 and 65 years of age with Major Depressive Disorder without~     psychotic features may be eligible for this 9-week study. Candidates must currently be in a~     major depressive episode of at least 4 weeks' duration, have failed to respond to treatment~     with an SSRI (Prozac, Zoloft, Paxil, Luvox, Celexa), and not have failed to respond to more~     than four antidepressants for the current episode. Candidates are screened with a physical~     examination, psychiatric evaluation, blood tests, review of vital signs, height and weight~     measurements, electrocardiogram (ECG), urine test for illegal drugs, and pregnancy test for~     women.~      Participants are tapered off antidepressants or other medications prohibited during the study~     and remain drug-free for 1 week before starting treatment. They are then randomly assigned to~     take pramipexole and escitalopram, pramipexole alone, or escitalopram alone for 6 weeks.~     During the study, participants come to the clinic eight times for health assessments and~     symptoms assessments, which include a check of vital signs and rating scales for depression~     and anxiety, adverse events, and sexual functioning. Blood and urine samples are collected~     periodically to monitor health, detect pregnancy in women, and detect illicit drug use.~      At the end of the 6-week treatment period, participants have a physical examination, ECG,~     blood test, and check of vital signs. Short-term anti-depressant treatment is offered, and~     plans are made for long-term treatment.~      Atendemos pacientes de habla hispana.~   "
264869|NCT00002505|"~     RATIONALE: Vaccines made from the patient's cancer cells may make the body build an immune~     response and kill their tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of autologous tumor cell~     vaccination plus immunologic adjuvant in treating patients who have metastatic cancer.~   "
264870|NCT00002482|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody and~     cyclophosphamide in treating patients with metastatic cancer.~   "
264851|NCT00086294|"~     This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's~     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of~     long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are~     affected in patients with Parkinson's disease.~      Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and~     80 years of age may be eligible for this study. Candidates are screened with a complete~     medical history and physical examination, neurological evaluation, blood and urine tests, and~     electrocardiogram (ECG). A brain magnetic resonance imaging (MRI) scan, CT scan, and chest~     x-ray may be done if medically indicated.~      Patients enrolled in the study will, if possible, stop taking all antiparkinsonian~     medications for one month (2 months for Selegiline) before the study begins and throughout~     its duration. Exceptions are Sinemet (levodopa/carbidopa), Mirapex (pramipexole) and Requip~     (ropinirole).~      Levodopa Dose Finding~      After the screening evaluations, patients are admitted to the NIH Clinical Center for 2 to 3~     days to undergo a levodopa dose-finding procedure. For this test, patients stop taking~     Sinemet and instead have levodopa infused through a vein. During the infusion, the drug dose~     is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side~     effects occur, or 3) the maximum study dose is reached. Side effects are monitored closely~     during the infusions, and parkinsonian symptoms are evaluated frequently during and after the~     infusions. The infusions usually begin early in the morning and continue until evening. Once~     the infusion is finished, patients resume taking their regular oral Sinemet dose. The~     infusions are repeated once a week during 1-day inpatient evaluations.~      Treatment~      Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill~     with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by~     ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission~     they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or~     changes in their condition. They also have an infusion of levodopa (see above) at the~     previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every~     30 minutes for about 6 hours. At the end of the infusions and ratings, patients are~     discharged home with their regular Parkinson's medications until the following visit.~      Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for~     a follow-up safety check. At that time, the investigator may ask the patient to return to the~     clinic for closer evaluation.~   "
264852|NCT00086255|"~     The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.~   "
264853|NCT00086216|"~     This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and~     to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.~   "
264854|NCT00002642|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and~     etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and~     etoposide, in treating patients who have stage III non-small cell lung cancer.~   "
264855|NCT00002565|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which combination chemotherapy regimen is more effective for intermediate-grade~     or immunoblastic non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic~     non-Hodgkin's lymphoma.~   "
264856|NCT00086242|"~     RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being~     and quality of life of patients who have cervical cancer. Changes in quality of life may be~     related to changes in immune function and neuroendocrine function.~      PURPOSE: This randomized phase I trial is studying how well telephone counseling works~     compared to standard care in reducing stress in patients who have completed treatment for~     stage I, stage II, or stage III cervical cancer.~   "
264857|NCT00086229|"~     The purpose of this study is to examine the way the dietary supplements glucosamine and~     chondroitin are absorbed and distributed throughout the body.~   "
264858|NCT00086203|"~     The objective of this study is to assess the efficacy and safety of talabostat and rituximab~     in patients with advanced CLL who failed to respond, or have progressed following a prior~     response, to a fludarabine regimen.~   "
264859|NCT00086190|"~     The purpose of this study is to find out if two antidepressant medications, paroxetine and~     venlafaxine, can help control depression in Parkinson's disease, and if these medications~     affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and~     balance.~   "
264860|NCT00086177|"~     This research study is being conducted at over 12 pregnancy research centers in the US. The~     study will compare an investigational treatment with a placebo (a treatment without~     medication). Neither the investigators nor the patients in the trial will know which~     treatment has been assigned. All study medications will be given vaginally once a day.~     Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy~     week 36.~   "
264861|NCT00086164|"~     The purpose of this study is to determine the effect of recipient vein pretreatment of~     edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in~     polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months~     after enrollment.~   "
264862|NCT00086151|"~     To develop a clinical prediction rule to identify patients with acute pulmonary embolism who~     are at very low risk for short-term adverse outcomes.~   "
264863|NCT00086138|"~     The purpose of this study is to learn whether treating individuals with Alzheimer's disease~     and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people~     with Alzheimer's disease and to their families and caregivers.~   "
264864|NCT00086125|"~     The purpose of this phase II study is to assess the efficacy of AP23573 in patients with~     specified relapsed or refractory hematological malignancies.~   "
264865|NCT00086112|"~     The purpose of this trial is to determine the effectiveness of risperidone as an adjunctive~     treatment in patients with GAD who demonstrate a less-than-optimal response to their current~     anxiolytic treatment.~   "
264866|NCT00006041|"~     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune~     response to kill the tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have ovarian, fallopian tube, or peritoneal cancer.~   "
264867|NCT00005975|"~     RATIONALE: Megestrol may be effective in treating hot flashes following treatment for breast~     cancer. It is not yet known which regimen of megestrol is most effective for hot flashes.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different doses of~     megestrol in treating hot flashes in patients who have undergone therapy for breast cancer.~   "
264868|NCT00005854|"~     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were~     destroyed by chemotherapy and radiation therapy used to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating~     patients who have hematologic cancer.~   "
264871|NCT00086099|"~     The primary objectives of this study are:~        1. To evaluate whether the addition of amifostine will allow for the safe administration of~          idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older~          patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); and~        2. To estimate the complete remission rate of induction therapy with amifostine, idarubicin~          (21 mg/m²), plus ara-C or induction therapy with idarubicin (12 mg/m²) plus ara-C in~          this patient population.~   "
264872|NCT00005613|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with allogeneic or autologous peripheral~     stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and~     kill more cancer cells.~      PURPOSE: Phase II trial to compare the effectiveness of allogeneic stem cell transplantation~     with that of autologous peripheral stem cell transplantation in treating patients who have~     non-Hodgkin's lymphoma or Hodgkin's disease.~   "
264873|NCT00004202|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation~     therapy, and RSR13 in treating patients who have stage III non-small cell lung cancer that~     cannot be removed by surgery.~   "
264874|NCT00004197|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Vaccines may make the body build an immune response to kill~     cancer cells. Colony-stimulating factors such as sargramostim may increase the number of~     immune cells found in bone marrow or peripheral blood and may help a person's immune system~     recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial of vaccine therapy plus sargramostim following chemotherapy in~     treating patients who have previously untreated aggressive non-Hodgkin's lymphoma.~   "
264875|NCT00004192|"~     RATIONALE: Colony-stimulating factors may increase the number of immune cells found in bone~     marrow or peripheral blood and may help a person's immune system recover from the side~     effects of chemotherapy.~      PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim-SD/01 with that~     of filgrastim to relieve the neutropenia following combination chemotherapy in patients who~     have non-Hodgkin's lymphoma.~   "
264876|NCT00003995|"~     Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab and~     chemotherapy with irinotecan in treating patients who have stage IV colorectal cancer that~     overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.~   "
264877|NCT00003946|"~     RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer.~      PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with~     advanced or recurrent endometrial cancer.~   "
264878|NCT00086086|"~     The purpose of this study is to evaluate whether weight-based or fixed starting doses result~     in comparable hemoglobin increases and treatment effects in patients with heart failure and~     anemia.~   "
264879|NCT00086073|"~     The purpose of this trial is to study genetic and other risk factors that may be important in~     the development of Parkinson's disease.~   "
264880|NCT00003762|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel~     plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung~     cancer.~   "
264881|NCT00003723|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating~     patients with malignant mesothelioma of the pleura that cannot be removed by surgery.~   "
264882|NCT00003691|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating~     patients who have stage III, stage IV, or recurrent endometrial cancer.~   "
264883|NCT00003667|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies use different ways to stimulate the immune~     system and stop cancer cells from growing. Combining chemotherapy with biological therapy may~     kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy~     with or without biological therapy in treating patients who have newly diagnosed high-risk~     Ewing's sarcoma.~   "
264884|NCT00003630|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients~     who have advanced solid tumors.~   "
264885|NCT00003549|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide,~     methotrexate, and fluorouracil in treating patients with Merkel cell cancer.~   "
264886|NCT00003369|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     tirapazamine plus cisplatin in treating patients who have metastatic, recurrent, or~     refractory cervical cancer.~   "
264902|NCT00006214|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to~     prevent the development of cancer. Flutamide may be effective in the prevention of prostate~     cancer.~      PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing~     prostate cancer in patients who have neoplasia of the prostate.~   "
264887|NCT00003317|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation~     therapy uses high-energy x-rays to damage tumor cells. It is not yet known if combination~     chemotherapy is more effective with or without radiation therapy for stage IIIA non-small~     cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without radiation therapy in treating patients who have stage IIIA non-small cell~     lung cancer that has been surgically removed.~   "
264888|NCT00003127|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with metastatic, recurrent, or refractory endometrial cancer.~   "
264889|NCT00086060|"~     Pain management techniques may influence how the brain processes pain and may help patients~     with fibromyalgia (FM), a chronic pain condition. This study will train patients with FM to~     use pain management techniques. Investigators will use brain scanning (functional magnetic~     resonance imaging, or fMRI) technology to identify changes in how a patient's brain processes~     pain over time. This study is primarily interested in examining cortical response to~     different behavioral interventions.~   "
264890|NCT00086047|"~     Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and~     difficulty in an adolescent's day-to-day activities. The purpose of this study is to~     determine whether coping skills training, when combined with usual medical care, can reduce~     pain and disability in adolescents with fibromyalgia.~      Study hypotheses: 1) Adolescents who receive coping skills training combined with their usual~     medical care will show significantly greater reductions in functional disability, pain, and~     depressive symptoms at the end of the acute treatment phase than adolescents who receive~     fibromyalgia education with their usual medical care. 2) Adolescents who receive coping~     skills training with their usual medical care will show significantly lower levels of~     functional disability, pain, and depressive symptoms at the end of a six-month maintenance~     phase than adolescents who receive fibromyalgia education with their usual medical care.~   "
264891|NCT00086034|"~     The primary purpose of this study is to find out if motexafin gadolinium may be an effective~     treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side~     effects of motexafin gadolinium will be evaluated.~   "
264892|NCT00003078|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy and chemotherapy may kill more tumor cells. It is not known~     whether receiving radiation therapy plus cisplatin is more effective than receiving radiation~     therapy plus fluorouracil in treating patients with cancer of the cervix.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus~     cisplatin or fluorouracil in treating patients with primary stage IIB, stage IIIB, or stage~     IVA cancer of the cervix.~   "
264893|NCT00002844|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating~     patients with chronic lymphocytic leukemia.~   "
264894|NCT00002816|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating~     children who have relapsed acute lymphoblastic leukemia.~   "
264895|NCT00002747|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not yet known if surgery plus radiation therapy is more effective with or without~     chemotherapy for treating mouth cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery and radiation~     therapy with or without chemotherapy in treating patients with stage II, stage III, or stage~     IV mouth cancer.~   "
264896|NCT00002725|"~     Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent~     non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells~     from dividing so they stop growing or die.~   "
264897|NCT00086021|"~     The purpose of this study is to determine whether acupuncture can reduce pain in long-term~     headache sufferers.~   "
264898|NCT00085969|"~     The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of~     exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.~   "
264899|NCT00085956|"~     The purposes of this study are to determine:~        -  The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in~          postmenopausal women.~        -  The effects of arzoxifene on the uterus (womb) in postmenopausal women.~        -  The effects of arzoxifene on blood tests that measure changes in bone rebuilding in~          postmenopausal women with low bone density.~        -  The effects of arzoxifene on blood lipids (fats) and other blood markers of heart~          disease risk.~        -  The safety of arzoxifene and any side effects that might be associated with its use.~   "
264900|NCT00006241|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy. Treating the peripheral stem cells in the~     laboratory to remove any existing cancer cells may improve the effectiveness of the~     transplant.~      PURPOSE: Randomized phase II trial to compare the effectiveness of treated peripheral stem~     cells with that of untreated stem cells in patients who have relapsed low- or~     intermediate-grade non-Hodgkin's lymphoma.~   "
264901|NCT00006235|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin and~     carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary~     peritoneal cancer.~   "
265001|NCT00085332|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with~     recurrent or persistent endometrial carcinoma (cancer).~   "
264903|NCT00006117|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating~     patients who have locally advanced or metastatic pancreatic cancer.~   "
264904|NCT00006116|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cisplatin with gemcitabine in~     treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
264905|NCT00006088|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase I trial to compare the effectiveness of two different regimens of~     vinorelbine in treating patients who have metastatic or advanced solid tumors.~   "
264906|NCT00002717|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which chemotherapy regimen is more effective for ovarian or peritoneal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of~     paclitaxel plus cisplatin in treating patients who have residual disease after surgery to~     remove stage III or stage IV ovarian cancer or primary peritoneal cancer.~   "
264907|NCT00002657|"~     RATIONALE: Reducing the amount of drugs used to prevent transplant rejection may help a~     person's body kill tumor cells. Giving biological therapy, such as interferon alfa, which may~     interfere with the growth of cancer cells, or combination chemotherapy, which uses different~     ways to stop tumor cells from dividing so they stop growing or die, may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of reducing immunosuppression, and giving~     interferon alfa and combination chemotherapy, in treating patients who have malignant tumors~     that develop after organ transplant.~   "
264908|NCT00085995|"~     This study will evaluate: 1) whether computed tomography (CT) scanning is better than regular~     x-rays for measuring changes in the stiffness, or fusion, of the spine in patients with~     ankylosing spondylitis; and 2) if CT can be used to determine how fast extra bone forms in~     the spine of these patients. Better ways to measure spinal fusion are needed to be able to~     evaluate the effectiveness of medicines in slowing or stopping its progression. CT uses~     x-rays to provide detailed pictures of the inside of the body and are valuable for detecting~     spinal abnormalities because of the precision with which it can show these structures. For~     the procedure, the patient lies on a table that moves into a large, donut-shaped scanner that~     can move around the body to take pictures at different angles, which are viewed on a computer~     monitor.~      Patients 18 years of age and older with ankylosing spondylitis who are not currently taking~     or planning to receive treatment with anti-TNF alpha medications (etanercept, infliximab,~     adalimumab) for 1 year may be eligible for this study. Participants have eight clinic visits,~     scheduled at study entry and at 4, 8, 12, 16, 20, 24, and 48 months, at the NIH Clinical~     Center for the following procedures:~        -  Clinical assessment (all visits) - includes medical history and physical examination,~          measurement of spine flexibility with a tape measure and protractor, symptoms~          questionnaire~        -  Blood tests for measures of inflammation, including red blood cell sedimentation rate~          and C-reactive protein level (all visits)~        -  Urine pregnancy test in women of child-bearing age (visits 1, 4, 7, 8)~        -  X-rays of the pelvis, low back, and neck (visits 1, 4, 7)~        -  X-ray of the low back (visit 8)~        -  CT scan of the low back (visits 1, 4, 7)~        -  Magnetic resonance imaging (MRI) of the low back (visits 1, 4) - MRI combines a powerful~          magnet with an advanced computer system and radio waves to produce accurate, detailed~          pictures of organs and tissues. The patient lies on a table in a narrow cylinder~          containing a magnetic field, wearing earplugs to muffle loud noises that occur with~          electrical switching of the magnetic fields. He or she can speak with a staff member via~          an intercom system at all times during the procedure. During the scan, a contrast dye~          (gadolinium) is injected into the bloodstream through a catheter (plastic tube inserted~          in a vein) to brighten the images.~      In addition, participants will complete a symptoms questionnaire by mail every 4 months for 2~     years between visits 7 and 8.~   "
264909|NCT00085982|"~     Leptin is a hormone produced by the fat cells that researchers have shown to play a role in~     controlling appetite. Certain people with severe insulin resistance have little or no leptin.~      The purpose of this study is to investigate people whose leptin levels have been found to be~     lower than 85 percent of the general population. Researchers will determine whether insulin~     levels in these participants improve when they are treated with genetically engineered~     leptin.~      Study participants must be age 8 years or older and must have severe insulin resistance~     syndrome and leptin deficiency. During an initial 7-day visit to the Clinical Center,~     researchers will evaluate participants' metabolic parameters, such as insulin responsiveness,~     lipid levels, appetite, and hormone levels. After taking these tests, participants will~     self-inject doses of leptin once or twice a day and will be monitored for treatment outcomes~     as well as side effects via follow-up visits. These inpatient follow-up visits will involve~     both blood tests and imaging studies at the Clinical Center at 4, 8, and 12 months after the~     initial visit, and every 6 months thereafter.~   "
264910|NCT00085943|"~     This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day~     or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose~     combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus~     levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and~     tolerability of these compounds over the 48 week study period in patients naive to anti-HIV~     therapy.~   "
264911|NCT00085930|"~     Patients have high-risk neuroblastoma, a form of cancer typically found in children. The~     patients previously participated in a gene transfer research study using special immune~     cells. This research study combines two different ways of fighting disease, antibodies and T~     cells. Antibodies are types of proteins that protect the body from bacterial and other~     infections. T cells, also called cytotoxic T lymphocytes or CTLs, are special~     infection-fighting blood cells that can kill some tumor cells. Both antibodies and T cells~     have been used to treat patients with cancers and while they have shown promise, they have~     not been strong enough to cure most patients. The antibody used in this study is called~     14g2a. This antibody sticks to neuroblastoma cells because of a substance on the outside of~     these cells called GD2. 14g2a and other antibodies that bind to GD2 have been used to treat~     people with neuroblastoma. For this study 14g2a has been changed so that instead of floating~     free in the blood, it is now joined to T cells. When an antibody is joined to a T cell in~     this way it is called a chimeric receptor. T lymphocytes or CTLs can kill tumor cells but~     there normally are not enough of them to kill all tumor cells. Some researchers have taken T~     cells from a person's blood, grown more of them in the laboratory and then given them back to~     the patient. Sometimes an antibody or chimeric receptor is attached to these T cells to help~     them bind to tumor cells. These chimeric receptor-T cells seem to kill some of the tumor, but~     they don't last very long in the body and so the tumor eventually comes back. We have found~     that T cells that are also trained to recognize the virus that causes infectious~     mononucleosis, Epstein Barr Virus (EBV), can stay in the blood stream for many years. By~     joining the 14g2a antibody to the CTLs that recognize EBV, we believe we will make a cell~     that can last a long time in the body (because they are EBV-specific) and recognize and kill~     neuroblastoma cells (because an antibody that can recognize these cells has been placed on~     their surface). Patients received treatment with the immune cells described above. They may~     want to receive an additional dose of these cells. This is being offered as an option because~     their neuroblastoma has returned and they have enough cells remaining to provide the patients~     with an additional dose. These 14g2a antibody CTLs are an investigational product not~     approved by the Food and Drug Administration.~   "
265002|NCT00085306|"~     RATIONALE: Interferon beta may interfere with the growth of tumor cells.~      PURPOSE: This phase II trial is studying how well interferon beta works in treating patients~     with metastatic cutaneous (skin) melanoma or ocular (eye) melanoma.~   "
264912|NCT00006035|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy~     drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more~     tumor cells.~      PURPOSE: Randomized phase I trial to compare the effectiveness of bleomycin with or without~     electroporation therapy in treating patients who have stage III or stage IV melanoma.~   "
264913|NCT00006033|"~     RATIONALE: Inserting the gene for interleukin-2 into head and neck cancer cells may make the~     body build an immune response to kill the tumor cells. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. It is not yet~     known whether the interleukin-2 gene is more effective than methotrexate for advanced head~     and neck cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of the interleukin-2 gene~     with that of methotrexate in treating patients who have recurrent or refractory stage III or~     stage IV head and neck cancer.~   "
264914|NCT00005993|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.~     Filgrastim and stem cell factor may increase the number of immune cells found in bone marrow~     or peripheral blood and may help a person's immune system recover from the side effects of~     cancer therapy. Peripheral stem cell transplantation may be able to replace immune cells that~     were destroyed by therapy used to kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 and stem cell factor~     following peripheral stem cell transplantation in treating patients who have non-Hodgkin's~     lymphoma, Hodgkin's disease, or advanced breast cancer.~   "
264915|NCT00005968|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have~     stage IV melanoma.~   "
264916|NCT00085904|"~     SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28~     days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6~     cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose~     levels of drug will be investigated. Safety evaluations, including blood sampling for various~     laboratory tests, will be conducted. Additional blood samples will also be taken to measure~     the amount of drug in the body at specific times.~   "
264917|NCT00085891|"~     The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine~     compared to placebo in patients with schizophrenia after receiving treatment for up to 6~     weeks.~   "
264918|NCT00085878|"~     This is a phase I, open-label, dose-escalation study of SB-485232. Subjects will receive~     SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation~     (enrollment into the next cohort) cannot occur until all three subjects have completed the~     previous cohort; 5 doses will be tested. An additional dosing regimen has been added to~     evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period~     for each patient will extend out to approximately eleven weeks after the first day of~     SB-485232 dosing.~   "
264919|NCT00083421|"~     The purpose of this study is to establish the presence of an effect of treatment with~     ONO-2506PO in patients with Alzheimer's Disease, based upon cognitive and global scales.~   "
264920|NCT00005829|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who~     have recurrent chronic lymphocytic leukemia.~   "
264921|NCT00005826|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have glioblastoma multiforme.~   "
264922|NCT00005616|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have colorectal cancer.~   "
264923|NCT00005093|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether gemcitabine plus CI-994 is more~     effective than gemcitabine alone for non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or~     without CI-994 in treating patients who have advanced non-small cell lung cancer.~   "
264924|NCT00005073|"~     RATIONALE: Zoledronate may be able to prevent bone metastases caused by prostate cancer. It~     is not yet known if zoledronate is effective in preventing the spread of prostate cancer to~     the bones.~      PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate plus~     standard therapy in preventing bone metastases in patients who have recurrent prostate cancer~     that is not causing symptoms.~   "
264925|NCT00005048|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining estramustine and paclitaxel in~     treating patients who have prostate cancer that has not responded to hormone therapy.~   "
264926|NCT00005041|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have~     relapsed small cell lung cancer.~   "
264927|NCT00004929|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy given with QS21 in~     treating patients who have progressive prostate cancer.~   "
264928|NCT00004861|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug or giving drugs in different ways may~     kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with or~     without CI-994 in treating patients who have advanced pancreatic cancer.~   "
264929|NCT00004260|"~     RATIONALE: Interleukin-12 may stimulate a person's white blood cells to kill lymphoma cells.~     Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or~     deliver cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 plus rituximab in~     treating patients who have non-Hodgkin's lymphoma.~   "
264930|NCT00004217|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. PSC 833 may help chemotherapy drugs kill more cancer cells by~     making them more sensitive to the drugs.~      PURPOSE: Phase II trial to study the effectiveness of PSC 833, daunorubicin, and cytarabine~     in treating older patients who have newly diagnosed acute myeloid leukemia.~   "
264931|NCT00085917|"~     This study will evaluate the safety and effectiveness of combination therapy with~     peginterferon alpha-2a and ribavirin for treating hepatitis C virus (HCV) infection in~     HIV-infected patients. Peginterferon alpha with ribavirin is the therapy of choice for people~     with HCV alone. Peginterferon alpha-2a is a compound that results from attaching a~     polyethylene glycol molecule to interferon alpha-2a. This compound stays in the blood longer~     than unmodified interferon alpha-2a, causing a higher blood concentration and thus~     maintaining greater activity against the hepatitis C virus.~      HIV-infected patients 18 years of age and older with chronic hepatitis C infection and a~     viral load greater than 2000 copies/mL may be eligible for this 2-1/2 year study. Candidates~     are screened with a medical history and physical examination, blood and urine tests, eye~     examination, chest x-ray, electrocardiogram (EKG), liver ultrasound, and pregnancy test in~     women who are able to become pregnant. If a recent liver biopsy is not available, this test~     is done to determine the type and severity of liver disease. The patient is given a sedative~     before the procedure. Then, the skin in the area over the biopsy site is numbed with a local~     anesthetic and a needle is inserted rapidly into and out of the liver to obtain a small~     tissue sample. The patient remains in the hospital overnight for monitoring.~      Participants begin treatment with injections under the skin of peginterferon alpha-2a and~     ribavirin pills by mouth on study day 0. Peginterferon is given either once or twice a week~     for 4 weeks and then once a week for 44 weeks. Ribavirin is given daily. In addition,~     patients continue to take all other medications prescribed by their doctor. Clinic visits are~     scheduled for the following procedures:~        -  Days 1, 3, 4, 7, 10 and weeks 2, 3, and 4 - Blood tests for safety measures and to~          measure blood levels of HIV and HCV.~        -  Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine tests to determine the~          side effects of treatment and its effect on the HCV infection. In addition, eye~          examinations are done every 3 months, and pregnancy and thyroid function tests are done~          several times during the treatment period.~        -  Week 48 or end of treatment - Treatment stops after 48 weeks. At this time, or earlier~          for those who do not complete the 48 weeks, patients return to the clinic for a chest~          x-ray, EKG, blood tests, and abdominal ultrasound. Patients are hospitalized for a~          repeat liver biopsy.~        -  Weeks 52, 56, 64 and 72 - Blood and urine tests to determine the side effects of~          treatment and its effect on the HCV infection, and a urine pregnancy test in women.~   "
264932|NCT00085852|"~     The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume~     Reduction (BLVR) System is safe in patients with advanced emphysema.~   "
264933|NCT00085839|"~     The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy~     of erlotinib and standard chemotherapy in patients with advanced, previously untreated~     nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG)~     performance status (PS) of 2. The study will also evaluate the safety of single-agent~     erlotinib in this patient population.~   "
264934|NCT00085826|"~     Taxotere has been approved by the FDA and is considered a standard treatment for patients~     with lung cancer who have failed prior platinum-containing regimens. The main purpose of this~     research study is to determine if Aptosyn, when given in combination with Taxotere, will~     result in prolonged survival when compared to Taxotere alone.~      This study will also help determine tumor response rates, and the safety profile of Aptosyn~     in combination with Taxotere.~      This study has been completed and a publication is pending.~   "
264935|NCT00085813|"~     This study was designed to determine how effective and safe Ispinesib is in treating locally~     advanced or metastatic Non-small Cell Lung cancer in patients who have received a~     platinum-based chemotherapy and whose disease continues to progress. Treatment involves a~     1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue~     treatment as long as they are benefiting from the treatment. Blood samples will be taken at~     specific times over 24 hr period to measure the amount of drug in your body at specific times~     after the drug is given. Blood samples will also be taken for routine lab tests such as~     complete blood counts and clinical chemistries. Physical exams will be performed before each~     treatment.~   "
264936|NCT00085800|"~     To investigate the relationship between dietary fiber and cardiovascular inflammatory~     markers.~   "
264937|NCT00085787|"~     This is a Phase 1 study during which patients with advanced solid tumors will receive~     investigational study drug ARRY-142886.~      This study has 2 parts. In the first part, patients will receive increasing doses of study~     drug in order to achieve the highest dose of study drug possible that will not cause~     unacceptable side effects. Approximately 25 patients from the US will be enrolled in Part 1~     (Completed).~      In the second part of the study, patients will receive the best dose of study drug,~     determined from the first part of the study, and will be followed to see what side effects~     the study drug causes and what effectiveness the study drug has, if any, in treating the~     cancer. Approximately 35 patients from the US will be enrolled in Part 2 (Completed).~   "
264938|NCT00085774|"~     This study was designed to examine the effectiveness of two bronchodilator inhalers in~     patients who have exercise-induced asthma.~   "
264939|NCT00085761|"~     The purpose of the study is to determine if an investigational drug, NGX-4010~     (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful~     HIV-associated neuropathy.~   "
264940|NCT00004251|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of letrozole in treating women who have~     recurrent or metastatic endometrial cancer.~   "
264941|NCT00004076|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of PNU 166148 in treating patients who have~     metastatic solid tumors that have not responded to previous treatment.~   "
264942|NCT00004043|"~     RATIONALE: Calcitriol, a form of vitamin D, may be able to prevent or slow the growth of~     prostate cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of calcitriol in treating patients who~     have a rising PSA level following previous treatment for prostate cancer.~   "
264943|NCT00003996|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have newly diagnosed glioblastoma multiforme.~   "
264957|NCT00003829|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Alternating treatment with more than one drug may kill more~     cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of fludarabine alternating with~     cyclophosphamide in treating patients who have previously untreated chronic lymphocytic~     leukemia.~   "
264944|NCT00003920|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver~     tumor-killing substances to them without harming normal cells. Peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells. Sometimes the transplanted cells can make an immune response against the body's~     normal tissues. Cyclosporine may prevent this from happening.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus~     cyclosporine and peripheral stem cell transplantation in treating patients who have~     metastatic breast cancer that has not responded to previous therapy.~   "
264945|NCT00003898|"~     RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system~     in children who are undergoing stem cell transplantation.~      PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in~     reducing inflammation of the mouth and digestive system in children who are undergoing~     peripheral stem cell transplantation.~   "
264946|NCT00003894|"~     RATIONALE: Thalidomide may interfere with the body's ability to recognize transplanted bone~     marrow cells as foreign and may help treat patients with graft-versus-host disease.~      PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating~     patients who have chronic graft-versus-host disease following bone marrow transplantation.~   "
264947|NCT00003891|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of lurtotecan liposome in treating patients~     who have advanced solid tumors.~   "
264948|NCT00085865|"~     This study will compare serotonin transporter proteins in people with alcoholism and healthy~     volunteers to examine how these proteins may be related to the inability of people with~     alcoholism to appropriately regulate their alcohol consumption. Serotonin transporters~     regulate levels of the brain chemical serotonin. Problems in this regulation have been~     implicated in alcoholism.~      Healthy normal volunteers and people who suffer from alcoholism who are between 18 and 75~     years of age may be eligible for this study. Candidates are screened with a medical history~     and physical examination, psychiatric diagnostic interview, blood and urine tests, an~     electrocardiogram, urine toxicology screen, and written psychological evaluations.~      Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI)~     scanning to measure serotonin transporter levels in the brain.~      PET uses small amounts of a radioactive chemical called a tracer that labels the serotonin~     transporters in the brain. The tracer used in this study is [11C]DASB. For the procedure, the~     subject lies on the scanner bed. A special mask is fitted to the head and attached to the bed~     to help keep the subject's head still during the scan so the images will be clear. A brief~     scan is done just before the radioactive tracer is injected. This scan provides measures of~     the brain that will help in the precise calculation of information from subsequent scans.~     After the tracer is injected through a catheter (plastic tube) placed in the arm, pictures~     are taken for about 2 hours.~      MRI uses a magnetic field and radio waves to produce pictures of brain structure. The subject~     lies on a bed that slides into the tube-like scanner, wearing earplugs to muffle loud noises~     the machine makes when the magnetic fields are switched. The scan takes about an hour, during~     which time the subject can communicate with the technician.~   "
264949|NCT00085748|"~     The primary objective of the study is to evaluate the safety and tolerability of flexible~     dosages of paliperidone ER as compared with placebo in patients with schizophrenia who are 65~     years of age or older. The primary objective of the open-label extension is the long-term~     assessment of safety and tolerability of paliperidone ER in patients diagnosed with~     schizophrenia.~   "
264950|NCT00085735|"~     This randomized phase III trial is studying how well standard-dose radiation therapy works~     compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard~     volume boost radiation therapy works compared to smaller volume boost radiation therapy when~     given together with chemotherapy in treating young patients who have undergone surgery for~     newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine,~     and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop~     growing or die. Giving radiation therapy with chemotherapy after surgery may kill any~     remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more~     effective than reduced-dose radiation therapy when given together with chemotherapy after~     surgery in treating young patients with medulloblastoma.~   "
264951|NCT00085722|"~     The purpose of this study is to determine whether prolotherapy (PrT), a therapy based on~     injection of a sugar solution in and around the knee, can decrease pain and disability from~     knee osteoarthritis (OA).~   "
264952|NCT00085709|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different~     ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies,~     such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Combining chemotherapy with~     gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction~     therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab~     ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective~     than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia.~      PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy~     and monoclonal antibody therapy to see how well they work in treating patients with~     previously untreated de novo acute myeloid leukemia.~   "
264953|NCT00085644|"~     The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given~     every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an~     inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal~     anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1~     disease-modifying antirheumatic drug (DMARD).~   "
264954|NCT00003871|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of PSA~     vaccines in treating patients who have advanced prostate cancer.~   "
264955|NCT00003860|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients who have small cell lung cancer.~   "
264956|NCT00003847|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy for the~     treatment of patients who have recurrent small cell lung cancer following treatment.~   "
264959|NCT00003624|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells~     from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing the risk of side~     effects caused by cisplatin and paclitaxel in treating women who have ovarian, peritoneal,~     cervical, fallopian tube, uterine, or endometrial cancer.~   "
264960|NCT00003592|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether methotrexate or paclitaxel is more~     effective in treating patients with advanced head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of methotrexate with that of~     paclitaxel in treating patients who have advanced head and neck cancer that cannot be treated~     with cisplatin.~   "
264961|NCT00003574|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     therapy in different ways may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients~     who are undergoing surgical removal of progressive or recurrent malignant brain tumors.~   "
264962|NCT00003381|"~     RATIONALE: Questionnaires that measure quality of life during treatment may improve the~     ability to plan treatment for patients with esophageal cancer.~      PURPOSE: This clinical trial is studying the quality of life in patients receiving treatment~     for esophageal cancer.~   "
264963|NCT00003254|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Ethynyluracil may help fluorouracil kill more cancer cells by~     making tumor cells more sensitive to the drug.~      PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus ethynyluracil in~     treating patients with advanced colorectal cancer that has not responded to fluorouracil.~   "
264964|NCT00003242|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy with bryostatin 1 plus~     paclitaxel and cisplatin in treating patients with advanced solid tumors.~   "
264965|NCT00003206|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating~     patients with locally recurrent or metastatic nasopharyngeal cancer.~   "
264966|NCT00003143|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal~     cells from the side effects of chemotherapy.~      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy~     with or without amifostine in treating patients with recurrent or refractory non-Hodgkin's~     lymphoma or Hodgkin's disease who are undergoing autologous stem cell transplantation.~   "
264967|NCT00003099|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of fenretinide and tamoxifen before surgery may~     be an effective way to prevent the recurrence of or further development of breast cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide and tamoxifen~     given before surgery in treating women with breast cancer.~   "
264968|NCT00003085|"~     RATIONALE: New diagnostic procedures, such as laparoscopic ultrasound, may improve the~     ability to detect pancreatic cancer and determine the extent of disease.~      PURPOSE: Phase II trial to study the effectiveness of laparoscopic ultrasound in diagnosing~     patients with stage I or stage II pancreatic cancer.~   "
264969|NCT00003028|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have~     recurrent or refractory solid tumors.~   "
264970|NCT00003009|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.~     Giving interleukin-2 in different ways may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of inhaled interleukin-2 in treating~     patients with metastatic or unresectable cancer.~   "
264971|NCT00002973|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several~     degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of melphalan and whole-body hyperthermia~     in treating patients with advanced melanoma.~   "
264972|NCT00002949|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining radiation therapy with chemotherapy with may kill more~     tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy with vinorelbine and~     paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the~     pelvis.~   "
264973|NCT00002915|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of penclomedine in treating patients who~     have advanced solid tumors.~   "
264974|NCT00002864|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen with or without octreotide may fight breast cancer by blocking the uptake of~     estrogen. It is not yet known which treatment regimen is more effective for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without~     octreotide in treating postmenopausal women who have stage I, stage II, or stage III breast~     cancer.~   "
264975|NCT00002838|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy and kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic~     leukemia.~   "
265004|NCT00085280|"~     This clinical trial is studying how well erlotinib works in treating patients with stage~     IIIB, stage IV, or recurrent non-small cell lung cancer. Erlotinib may stop the growth of~     tumor cells by blocking the enzymes necessary for their growth.~   "
264976|NCT00002785|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. Bone~     marrow transplantation may allow the doctor to give higher doses of chemotherapy and kill~     more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, bone marrow~     transplantation, and radiation therapy in treating infants with acute lymphoblastic leukemia.~   "
264977|NCT00002740|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may allow doctors to give~     higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses~     high-energy x-rays to damage tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral~     stem cell transplantation followed by surgery and/or radiation therapy in treating young~     patients who have newly diagnosed advanced neuroblastoma.~   "
264978|NCT00085696|"~     The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given~     in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell~     Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the~     time it takes your lymphoma to get worse.~   "
264979|NCT00085683|"~     This study will explore whether the human herpes virus-6 is associated with epileptic~     seizures. The virus may be involved in brain scarring, called mesial temporal sclerosis,~     which is seen in some epilepsy patients. The virus is also thought possibly to interfere with~     neurotransmitters - chemicals that brain cells use to communicate with each other. This study~     will measure levels of two of these chemicals, GABA and glutamate, which are believed to play~     a role in the development of seizures.~      Patients with epilepsy, with or without mesial temporal sclerosis, and healthy control~     subjects 18 years of age and older may be eligible for this study. Control subjects may not~     be taking any medication on a regular basis. Epilepsy patients may take only phenytoin,~     carbamazepine, oxcarbazepine, lamotrigine, or levetiracetam. Candidates are screened with a~     physical examination and blood tests.~      Participants have blood drawn and undergo magnetic resonance imaging (MRI) and lumbar~     puncture (spinal tap).~      Blood Draw~      Up to four teaspoons of blood are drawn through a needle in the arm for this study.~      MRI~      MRI uses a magnetic field and radio waves to produce pictures of the brain. The scanner is a~     metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a~     bed that slides into the cylinder, wearing earplugs to muffle loud noises the machine makes~     when the magnetic fields are switched. The scan takes about 90 to 120 minutes, during which~     time the subject can communicate with the technician.~      Lumbar Puncture~      For this test the subject sits upright or lies on his or her side with knees curled at the~     chest. A local anesthetic is injected at the lower back, and a needle is inserted in the~     space between the bones where the cerebrospinal fluid circulates below the spinal cord. A~     small amount of fluid is collected through the needle. Collection of the fluid usually takes~     from 5 to 20 minutes.~   "
264980|NCT00085670|"~     This study will examine whether cytokine gene polymorphisms affect the progression or~     response to therapy of bone marrow failure disorders. Cytokine genes instruct cells to~     produce proteins called cytokines that influence immune system response. As with many genes,~     the cytokine genes differ slightly from person to person. These differences are called gene~     polymorphisms. Different patients with the same bone marrow failure disease often progress~     and respond to treatment differently. This study will look at the possible role of cytokine~     gene polymorphisms in these differences.~      Patients between 2 and 80 years old who have participated in an NHLBI Hematology Branch~     treatment protocol for acquired aplastic anemia, myelodysplastic syndrome, or pure red cell~     aplasia are recruited to participate in this study. Blood collected and stored at the time of~     screening for the treatment protocol will be tested for cytokine gene polymorphisms. No~     additional tests, procedures, or treatments are involved in this study.~   "
264981|NCT00085657|"~     This study will examine whether brain stimulation using transcranial direct current~     stimulation (tDCS) in stroke patients undergoing rehabilitation therapy can help patients~     recover strength and motor function more than rehabilitation therapy alone. For tDCS, two~     small metal disks (electrodes) attached to wires are placed on small cotton pads and taped to~     the subject's head, one on the forehead above the eye and the other on the top of the head.~     The electrodes deliver a brief electrical current that stimulates the cortex, the part of the~     brain responsible for motor function.~      Adult patients who have weakness on one side of their body as a result of a stroke occurred~     within the last 15 days may be eligible for this study. NIH is not directly recruiting~     patients for this study. Patients will be selected through the National Rehabilitation~     Hospital (NRH) Research Center personnel in Washington, DC, from patients under treatment at~     that facilitiy. Candidates are screened with a physical and neurologic examination, a review~     of tests done on admission to NRH, and a magnetic resonance imaging (MRI) scan, if one has~     not been done since the stroke. MRI uses a strong magnetic field and radio waves to obtain~     images of the brain. The MRI scanner is a metal cylinder surrounded by a strong magnetic~     field. During the MRI, the patient lies on a table that can slide in and out of the cylinder.~     Scanning time for this study takes about 30 to 45 minutes.~      Participants are randomly assigned to receive tDCS or placebo stimulation, along with~     rehabilitation therapy, for 2 to 3 weeks, depending on the patient's length of stay at the~     NRH. For the placebo stimulation, electrodes are placed on the patient's scalp as with tDCS,~     but no current is delivered. Before and after each rehabilitation session with electrodes,~     patients undergo Jebsen Taylor motor testing, in which they are asked to lift small objects,~     turn cards, use a spoon, stack checkers, and lift cans as fast as they can.~      On the day of discharge, patients have physical and neurological examinations and the motor~     function tests described below. The motor tests are repeated, along with standard care and a~     review of their health status, during outpatient follow-up visits scheduled at 3, and 12~     months. The motor tests are:~        -  Wolf motor function test - Patients are asked to raise a forearm on a table, on a box,~          to reach across a table, push a sandbag, place a hand on the table, pull a weight, lift~          a can, pick up a pencil, pick up a paper clip, stack checkers, flip cards, use a key,~          fold a towel, and pick up a basket.~        -  Barthel index - Patients are timed for the speed with which they perform certain tasks,~          such as feeding, grooming, or moving a wheelchair.~        -  Abilhand questionnaire - Patients answer questions about how they perform routine daily~          activities.~        -  GOT test of tactile discrimination - Patients describe objects they feel with their~          hand.~        -  Ashworth spasticity scale - A medical staff person moves the patient's arm back and~          forth to see how stiff it is.~   "
264982|NCT00085631|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy~     x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to~     several degrees above body temperature. It is not yet known whether chemotherapy and~     radiation therapy are more effective with or without hyperthermia therapy in treating~     cervical cancer.~      PURPOSE: This randomized phase III trial compared the safety and efficacy of cisplatin and~     radiation therapy, together with hyperthermia therapy versus cisplatin and radiation therapy~     alone in the treatment of locally advanced cervical cancer.~   "
264983|NCT00085579|"~     RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill~     melanoma cells.~      PURPOSE: This phase II trial is studying how well giving interleukin-2 together with~     sargramostim works in treating patients with stage III or stage IV melanoma that was~     previously treated with chemotherapy.~   "
264984|NCT00085566|"~     RATIONALE: Everolimus may stop the growth of tumor cells by stopping blood flow to the tumor.~     Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth. Combining everolimus with gefitinib may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when~     given together with gefitinib and to see how well they work in treating patients with~     progressive glioblastoma multiforme or (progressive metastatic prostate cancer closed to~     accrual 10/19/06).~   "
264985|NCT00085553|"~     This phase I trial studies the side effects and best dose of tipifarnib and erlotinib~     hydrochloride in treating patients with solid tumors that have spread to other places in the~     body. Tipifarnib and erlotinib hydrochloride may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
264986|NCT00085540|"~     This phase I/II trial is studying the side effects and best dose of FR901228 and to see how~     well it works in treating patients with recurrent high-grade gliomas. FR901228 may stop the~     growth of tumor cells by blocking the enzymes necessary for their growth~   "
264987|NCT00085527|"~     RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth.~      PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with~     relapsed or refractory advanced ovarian epithelial cancer.~   "
265003|NCT00085293|"~     This phase II trial is studying how well decitabine works in treating patients with~     metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding~     to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells.~     Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine.~     Decitabine may help thyroid cancer cells regain the ability to respond to treatment with~     radioactive iodine.~   "
271144|NCT00037323|"~     To examine the relationship between psychosocial characteristics, health behaviors, and the~     development of coronary heart disease among participants in the Framingham Offspring Study.~   "
264988|NCT00085501|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies~     such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing~     substances to them without harming normal cells. Combining more than one chemotherapy drug~     with a monoclonal antibody may kill more tumor cells. It is not yet known whether cetuximab~     is more effective when given at the same time as chemotherapy or following chemotherapy.~      PURPOSE: This randomized phase II trial is studying how well giving cetuximab at the same~     time as combination chemotherapy works compared to giving cetuximab after combination~     chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.~   "
264989|NCT00085488|"~     RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body~     build an immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with stage III or stage IV melanoma.~   "
264990|NCT00085475|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes~     necessary for their growth.~      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating~     patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell~     fibroblastoma.~   "
264991|NCT00085462|"~     RATIONALE: Inserting a gene that has been created in the laboratory into a person's white~     blood cells may make the body build an immune response to kill tumor cells. Interleukin-2 may~     stimulate a person's white blood cells to kill tumor cells. Vaccines may make the body build~     an immune response to kill tumor cells. Combining gene-modified white blood cell infusions~     with interleukin-2 and vaccine therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying how well giving gene-modified white blood cells when~     given together with interleukin-2 and vaccine therapy works in treating patients with~     metastatic melanoma.~   "
264992|NCT00085449|"~     RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy~     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.~     It also stops the patient's immune system from rejecting the donor's stem cells when they do~     not exactly match the patient's blood. The donated stem cells may replace the patient's~     immune system and help destroy any remaining cancer cells (graft-versus-tumor effect).~     Sometimes the transplanted cells from a donor can also make an immune response against the~     body's normal cells. Giving cyclosporine and mycophenolate mofetil before transplant may stop~     this from happening.~      PURPOSE: This phase I/II trial is studying the side effects of alemtuzumab, fludarabine, and~     melphalan with or without cyclosporine, mycophenolate mofetil, and total-body irradiation~     before donor peripheral blood stem cell transplant and to see how well they work in treating~     patients with relapsed or refractory hematologic cancer.~   "
264993|NCT00085436|"~     RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body~     build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's~     lymphocytes to kill kidney cancer cells. Interferon alfa may interfere with the growth of~     cancer cells. Combining vaccine therapy with interleukin-2 and interferon alfa may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with~     interleukin-2 and interferon alfa works in treating patients with metastatic renal cell~     carcinoma (kidney cancer).~   "
264994|NCT00085423|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2~     may stimulate a person's white blood cells to kill tumor cells and may help a person's immune~     system recover from the side effects of chemotherapy.~      PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine~     together with high-dose interleukin-2 works in treating patients with metastatic melanoma.~   "
264995|NCT00085410|"~     This phase II trial is studying how well bortezomib works as first-line systemic therapy in~     treating patients with unresectable locally advanced or metastatic adenocarcinoma (cancer) of~     the bile duct or gallbladder. Bortezomib may stop the growth of tumor cells by blocking the~     enzymes necessary for their growth.~   "
264996|NCT00085397|"~     RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune~     response to kill tumor cells. It is not yet known whether combining vaccine therapy with~     either gp100 antigen or the patient's tumor cells will cause a stronger immune response and~     kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see~     how well they work compared to vaccine therapy and patient's tumor cells in treating patients~     with stage III or stage IV melanoma.~   "
264997|NCT00085384|"~     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian~     epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based~     chemotherapy.~   "
264998|NCT00085371|"~     This phase II trial is studying how well triapine works as first-line or second-line therapy~     in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the~     pancreas. Drugs used in chemotherapy, such as triapine, work in different ways to stop tumor~     cells from dividing so they stop growing or die.~   "
264999|NCT00085358|"~     This phase I trial is studying the side effects and best dose of intraperitoneal infusions of~     carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel~     followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or~     stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer).~     Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one~     drug and giving them in different ways may kill more tumor cells~   "
265000|NCT00085345|"~     RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic~     acid, work in different ways to stop cancer cells from dividing so they stop growing or die.~     Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making~     them more sensitive to the drugs.~      PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic~     trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple~     myeloma.~   "
265005|NCT00085254|"~     Cilengitide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Giving cilengitide together with temozolomide and~     radiation therapy may kill more tumor cells. This randomized phase I/II trial is studying the~     side effects and best dose of cilengitide when given together with temozolomide and radiation~     therapy and to compare how well they work in treating patients with newly diagnosed~     glioblastoma multiforme~   "
265006|NCT00085228|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Oblimersen may increase the~     effectiveness of docetaxel by making tumor cells more sensitive to the drug.~      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with~     oblimersen works compared to docetaxel alone in treating patients with hormone-refractory~     adenocarcinoma (cancer) of the prostate.~   "
265007|NCT00085202|"~     Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with~     chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to~     replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is~     not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell~     transplant is more effective in treating medulloblastoma, supratentorial primitive~     neuroectodermal tumor, or atypical teratoid rhabdoid tumor.~      This phase III trial is studying two different regimens of radiation therapy when given~     together with chemotherapy and autologous stem cell transplant to see how well they work in~     treating patients with newly diagnosed medulloblastoma, supratentorial primitive~     neuroectodermal tumor, or atypical teratoid rhabdoid tumor.~      PRIMARY OBJECTIVE:~        -  To assess the relationship between ERBB2 protein expression in tumors and~          progression-free survival probability for patients with medulloblastoma.~        -  To estimate the frequency of mutations associated with SHH and WNT tumors (as defined by~          gene expression profiling) via targeted sequencing performed in an independent cohort of~          WNT and SHH tumors (also defined by gene expression profiling).~   "
265008|NCT00085189|"~     This pilot phase II trial studies how well giving vaccine therapy works in treating patients~     with stage IIC-IV melanoma. Vaccines made from melanoma peptides or antigens may help the~     body build an effective immune response to kill tumor cells~   "
265009|NCT00085176|"~     RATIONALE: Cancer therapies may affect the ability of a child's brain and central nervous~     system to function normally. Learning to identify which patients will develop complications~     may improve the ability of doctors to plan cancer treatment and improve patient quality of~     life.~      PURPOSE: This clinical trial is studying neurobehavioral changes in children who have~     received steroid therapy or intrathecal therapy for acute lymphoblastic leukemia.~   "
265010|NCT00085163|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the~     growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known~     whether fluorouracil and leucovorin are more effective with or without celecoxib in treating~     resected stage III adenocarcinoma (cancer) of the colon.~      PURPOSE: This randomized phase III trial is studying celecoxib, fluorouracil, and leucovorin~     to see how well they work compared to fluorouracil and leucovorin in treating patients who~     have undergone surgery for stage III colon cancer.~   "
265011|NCT00085150|"~     RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin~     in treating young patients with relapsed or refractory leukemia or lymphoma.~   "
265012|NCT00085124|"~     This randomized phase III trial is studying daunorubicin, cytarabine, and oblimersen to see~     how well they work compared to daunorubicin and cytarabine in treating older patients with~     previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin~     and cytarabine, work in different ways to stop cancer cells from dividing so they stop~     growing or die. Oblimersen may increase the effectiveness of daunorubicin and cytarabine by~     making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and~     cytarabine are more effective with or without oblimersen in treating acute myeloid leukemia.~   "
265013|NCT00085111|"~     This phase I trial is studying the side effects and best dose of bevacizumab in treating~     young patients with refractory solid tumors. Monoclonal antibodies, such as bevacizumab, can~     locate tumor cells and either kill them or deliver tumor-killing substances to them without~     harming normal cells.~   "
265014|NCT00085098|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus~     radiation therapy in treating germ cell tumor.~      PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well~     it works compared to chemotherapy and radiation therapy in treating patients with newly~     diagnosed primary CNS germ cell tumor.~   "
265015|NCT00085059|"~     RATIONALE: Boron neutron capture therapy using boronophenylalanine-fructose complex may kill~     tumor cells without harming normal tissue.~      PURPOSE: This phase II trial is studying how well boron neutron capture therapy using~     boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.~   "
265016|NCT00085020|"~     RATIONALE: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either~     kill them or deliver tumor-killing substances to them without harming normal cells. Giving~     GW572016 with trastuzumab may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given~     together with trastuzumab in treating patients with metastatic breast cancer that~     overexpresses HER2/neu.~   "
265017|NCT00084981|"~     This phase I trial is studying the side effects and best dose of decitabine and valproic acid~     in treating patients with non-small cell lung cancer. Drugs used in chemotherapy, such as~     decitabine and valproic acid, work in different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~   "
265018|NCT00084942|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Combining more~     than one chemotherapy drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine~     in treating patients who have advanced and/or inoperable cholangiocarcinoma or carcinoma~     (cancer) of the gallbladder.~   "
265019|NCT00084929|"~     RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve~     the ability to detect colorectal cancer and may provide a less invasive method of detection.~      PURPOSE: This clinical trial is studying how well computed tomographic colonography works in~     screening healthy participants for colorectal cancer.~   "
265020|NCT00084916|"~     Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from~     dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works~     in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic~     leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase~   "
265021|NCT00084903|"~     RATIONALE: New diagnostic procedures such as fluorescence and reflectance spectroscopy~     (shining light on tissue and measuring patterns of light reflected) may improve the ability~     to noninvasively detect cervical intraepithelial neoplasia and dysplasia.~      PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy~     during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in~     healthy participants with a history of normal Pap smears.~   "
265022|NCT00084890|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with~     carboplatin may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when~     given together with carboplatin and to see how well they work in treating patients with~     recurrent stage IVB squamous cell carcinoma (cancer) of the cervix.~   "
265023|NCT00084877|"~     This phase I trial is studying the side effects and best dose of irinotecan and 3-AP in~     treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy~     such as irinotecan work in different ways to stop tumor cells from dividing so they stop~     growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth and may help irinotecan kill more tumor cells by making them more sensitive to~     the drug.~   "
265024|NCT00084864|"~     RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells.~      PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with~     dexamethasone before radical prostatectomy works in treating patients with localized stage II~     or stage III adenocarcinoma (cancer) of the prostate.~   "
265025|NCT00084838|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Giving more than one chemotherapy drug with radiation therapy may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination~     chemotherapy together with radiation therapy works in treating young patients with newly~     diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.~   "
265026|NCT00084825|"~     RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor~     cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of~     tumor cells by blocking the enzymes necessary for their growth. Giving docetaxel with~     imatinib mesylate may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel with imatinib mesylate~     works in treating patients with androgen-independent prostate cancer and bone metastases that~     progressed while receiving docetaxel and a placebo on clinical trial MDA-ID-030008.~   "
265027|NCT00084812|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Safingol may stop the growth of tumor~     cells by blocking the enzymes necessary for their growth and by stopping blood flow to the~     tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of safingol when given~     with cisplatin in treating patients with locally advanced or metastatic solid tumors.~   "
265028|NCT00084799|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: This phase I trial is studying the side effects of monoclonal antibody therapy in~     treating patients with progressive small cell lung cancer.~   "
265029|NCT00084786|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Drugs used in chemotherapy such as docetaxel work in different ways to stop~     tumor cells from dividing so they stop growing or die. Giving gefitinib with docetaxel may~     kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib when~     given with docetaxel in treating patients with advanced solid tumors.~   "
265030|NCT00084773|"~     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy such as fluorouracil work in different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Giving cetuximab with fluorouracil and radiation therapy may kill more tumor cells.~   "
265031|NCT00084747|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary~     for their growth. Giving bortezomib as maintenance therapy after autologous stem cell~     transplantation may kill more cancer cells and prolong remission.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant~     bortezomib as maintenance therapy and to see how well it works in treating patients who have~     undergone stem cell transplantation for intermediate or advanced multiple myeloma.~   "
265032|NCT00084734|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, capecitabine, and cisplatin, work~     in different ways to stop tumor cells from dividing so they stop growing or die. Giving more~     than one chemotherapy drug may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel,~     capecitabine, and cisplatin in treating patients with metastatic or unresectable solid~     tumors.~   "
265033|NCT00084721|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor~     cells by blocking the enzymes necessary for their growth. Giving irinotecan with celecoxib~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when~     given with celecoxib in treating patients with unresectable or metastatic colorectal cancer.~   "
265034|NCT00084708|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Calcitriol may help tumor cells develop into normal cells. Dexamethasone may~     increase the effectiveness and decrease the side effects of gefitinib and calcitriol.~      PURPOSE: This phase I trial is studying the side effects and best dose of calcitriol when~     given together with gefitinib or when given together with gefitinib and dexamethasone in~     treating patients with advanced solid tumors.~   "
265035|NCT00084695|"~     RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy.~      PURPOSE: This phase II trial is studying how well umbilical cord blood works as a source of~     stem cells in treating patients with types of cancer as well as other diseases.~   "
265036|NCT00084682|"~     This phase II trial is studying how well FR901228 works in treating patients with~     unresectable recurrent or metastatic squamous cell carcinoma (cancer) of the head and neck.~     Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from~     dividing so they stop growing or die.~   "
265037|NCT00084669|"~     RATIONALE: Venlafaxine may be effective in relieving hot flashes caused by hormone therapy.~     Giving venlafaxine with zolpidem (a sleeping pill) may improve sleep and quality of life in~     women who are receiving hormone therapy for treatment or prevention of breast cancer.~      PURPOSE: This randomized clinical trial is studying giving venlafaxine together with zolpidem~     to see how well it works compared to venlafaxine alone in relieving hot flashes and~     associated sleep disorders in women who are receiving hormone therapy to treat or prevent~     breast cancer.~   "
265038|NCT00084656|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Vaccines may make the body~     build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51~     may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody~     therapy together with vaccine therapy may be an effective treatment for stage III or stage IV~     melanoma.~      PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together~     with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.~   "
265039|NCT00084643|"~     This phase I trial is studying the side effects and best dose of capecitabine when given~     together with GTI-2040 and oxaliplatin in treating patients with locally advanced or~     metastatic colorectal cancer or other solid tumors. Drugs used in chemotherapy, such as~     oxaliplatin and capecitabine, work in different ways to stop tumor cells from dividing so~     they stop growing or die. GTI-2040 may increase the effectiveness of chemotherapy by making~     tumor cells more sensitive to the drugs. Giving GTI-2040 together with oxaliplatin and~     capecitabine may kill more tumor cells~   "
265040|NCT00084630|"~     This phase II trial is studying how well imatinib mesylate works in treating patients with~     locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed~     fibrosarcomatous DFSP (a type of soft tissue sarcoma). Imatinib mesylate may stop the growth~     of tumor cells by blocking the enzymes necessary for their growth~   "
265041|NCT00084617|"~     Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Giving more~     than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how~     well giving oxaliplatin together with irinotecan and capecitabine works in treating patients~     with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction~     adenocarcinoma (cancer).~   "
265042|NCT00084604|"~     This phase II trial is studying how well giving irinotecan and cisplatin together with~     bevacizumab works in treating patients with unresectable or metastatic gastric (stomach) or~     gastroesophageal junction adenocarcinoma (cancer). Drugs used in chemotherapy, such as~     irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they~     stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells.~     Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.~   "
265043|NCT00084591|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.~     Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in~     standard radiation therapy) with incorporated boost (an increase in the amount of radiation~     given during treatment) may cause less damage to normal tissue. Drugs used in chemotherapy,~     such as capecitabine, work in different ways to stop tumor cells from dividing so they stop~     growing or die. Giving radiation therapy together with chemotherapy before surgery may shrink~     the tumor so it can be removed.~      PURPOSE: This phase I trial is studying the side effects and best dose of neoadjuvant~     intensity-modulated radiation therapy with incorporated boost when given together with~     capecitabine in treating patients with locally advanced rectal cancer.~   "
265044|NCT00084578|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth and by stopping blood flow to the tumor. Rosiglitazone may help tumor cells~     develop into normal bladder cells.~      PURPOSE: This randomized clinical trial is studying how well giving celecoxib together with~     rosiglitazone works in treating patients who are undergoing cystoscopic surveillance~     (screening) for early-stage noninvasive (carcinoma in situ) carcinoma (cancer) of the bladder~     or radical cystectomy for muscle-invasive carcinoma (cancer has spread into the muscle layer~     of bladder tissue) of the bladder.~   "
265045|NCT00084565|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work~     in different ways to stop tumor cells from dividing so they stop growing or die. Giving more~     than one chemotherapy drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and~     estramustine together works in treating patients with metastatic hormone therapy-refractory~     prostate cancer.~   "
265046|NCT00084552|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.~     Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in~     standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet~     known whether reducing the dose of radiation to erectile tissue will help prevent erectile~     dysfunction.~      PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy~     alone to see how well it works compared to intensity-modulated radiation therapy with reduced~     doses to erectile tissue in treating patients with stage II prostate cancer.~   "
265047|NCT00084539|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated~     (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy~     (radiation directed at the tumor more precisely than in standard radiation therapy) with~     incorporated boost (an increase in the amount of radiation given during treatment) may kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well adjuvant hypofractionated~     intensity-modulated radiation therapy with incorporated boost works in treating patients with~     early-stage breast cancer.~   "
265048|NCT00084526|"~     RATIONALE: New imaging procedures such as CT-on-rails™ may improve the ability to pinpoint~     the location of the tumor and decrease radiation therapy damage to healthy tissue.~      PURPOSE: This phase I/II trial is studying how well computed tomography (CT) scans using~     CT-on-rails™ work in pinpointing the location of the tumor in patients with prostate cancer.~   "
265049|NCT00084513|"~     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Imatinib~     mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth and by stopping blood flow to the tumor. Giving trastuzumab together with imatinib~     mesylate may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate~     when given together with trastuzumab in treating patients with recurrent or metastatic~     HER2/neu-expressing (producing) cancer.~   "
265050|NCT00084487|"~     Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor~     cells from dividing so they stop growing or die. This phase II trial is studying how well~     rebeccamycin analog works as second-line therapy in treating patients with limited-stage or~     extensive-stage small cell lung cancer that has relapsed after previous first-line~     chemotherapy.~   "
265051|NCT00084461|"~     Phase II trial to study the effectiveness of romidepsin in treating patients who have locally~     advanced or metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as romidepsin,~     work in different ways to stop tumor cells from dividing so they stop growing or die.~   "
265052|NCT00084448|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of~     cancer by stopping blood flow to the tumor and may increase the effectiveness of paclitaxel~     by making tumor cells more sensitive to the drug. Giving celecoxib together with paclitaxel~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel together with celecoxib~     works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial~     or primary peritoneal cancer.~   "
265053|NCT00084435|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells~     more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any~     remaining tumor cells.~      PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin~     and docetaxel works in treating patients with completely resected stage III or stage IV head~     and neck cancer.~   "
265054|NCT00084422|"~     RATIONALE: CEP-701 may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of CEP-701 in treating~     young patients with recurrent or refractory high-risk neuroblastoma.~   "
265055|NCT00084409|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Iloprost may be effective in preventing lung cancer.~      PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing~     lung cancer in patients who are at high risk for this disease.~   "
265056|NCT00084396|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by reducing the production of estrogen. Giving letrozole~     before surgery may shrink the tumor so that it can be removed.~      PURPOSE: This phase II trial is studying how well neoadjuvant letrozole works in treating~     postmenopausal women who are undergoing surgery for estrogen-receptor positive or~     progesterone-receptor positive stage II, stage IIIA, or stage IIIB breast cancer.~   "
265057|NCT00084383|"~     RATIONALE: Vaccines made from gene-modified pancreatic cancer cells may make the body build~     an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil,~     work in different ways to stop tumor cells from dividing so they stop growing or die.~     Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy~     together with chemotherapy and radiation therapy after surgery may kill any remaining tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with~     adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II~     adenocarcinoma (cancer) of the pancreas.~   "
265058|NCT00084370|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of celecoxib before prophylactic oophorectomy~     may be an effective way to prevent the development of ovarian epithelial cancer.~      PURPOSE: A controlled pilot trial to study the effectiveness of celecoxib in preventing~     cancer in patients at high-risk for ovarian epithelial cancer who are undergoing prophylactic~     oophorectomy.~   "
265059|NCT00084344|"~     RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased~     risk of developing breast cancer. 4-hydroxytamoxifen gel (a substance made when tamoxifen~     breaks down in the body) may be effective in reducing breast density by reducing estrogen~     levels with fewer side effects than tamoxifen. This may improve quality of life and the~     ability to detect breast cancer with screening mammography.~      PURPOSE: Randomized screening study to determine the effect of 4-hydroxytamoxifen gel on~     breast density, salivary sex steroids (hormones), and quality of life in premenopausal women.~   "
265060|NCT00084318|"~     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells~     from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to~     radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them~     after surgery may kill any remaining tumor cells.~      PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with~     chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab~     given together with chemoradiotherapy using docetaxel in treating patients with resected~     stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and~     neck.~   "
265061|NCT00084279|"~     To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha~     and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who~     are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.~   "
265062|NCT00084266|"~     To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired~     in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult~     subjects. Subjects entered in to the study will have proven healthcare-associated~     methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either~     linezolid or vancomycin.~   "
265063|NCT00084253|"~     The purpose of this study is to find out if 300 mg of ATV plus 100 mg of ritonavir (RTV)~     works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to~     slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs.~   "
265064|NCT00084240|"~     The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily~     for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus~     chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.~   "
265065|NCT00084227|"~     The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is~     non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria~     due to P. falciparum.~   "
265066|NCT00084305|"~     The etiology of pulmonary fibrosis is unknown. Analyses of blood, genomic DNA, and specimens~     procured by bronchoscopy, lung biopsy, lung transplantation, clinically-indicated~     extra-pulmonary biopsies, or post-mortem examination from individuals with this disorder may~     contribute to our understanding of the pathogenic mechanisms of pulmonary fibrosis. The~     purpose of this protocol is to procure and analyze blood, genomic DNA, and specimens by~     bronchoscopy, lung biopsy, lung transplantation, extra-pulmonary biopsies, or post-mortem~     examination from subjects with pulmonary fibrosis. In addition, blood, genomic DNA,~     clinically-indicated extra-pulmonary biopsies, as well as bronchoscopy and post-mortem~     examination specimens may be procured and analyzed from relatives of subjects with hereditary~     forms of pulmonary fibrosis; blood, genomic DNA, and bronchoscopy specimens may be procured~     from healthy research volunteers.~   "
265067|NCT00084292|"~     This multi-center collaborative study will establish a database of information about stroke~     in infants and children.~      Participating children have their medical and research records reviewed for information about~     their stroke. The information is gathered and entered into a secure electronic database~     called REDCap. All information is de-identified.~      This study does not require any additional interventions but two outcome measures are~     typically administered: the Paediatric Stroke Outcome Measure (PSOM) and the Recovery and~     Recurrence Questionnaire (RRQ). The PSOM is used during clinic visits by the study~     co-investigator; the RRQ is a parental questionnaire that can be completed during clinic~     visits or by telephone interview for those parents who cannot attend the follow up~     appointment. Both measures assess neurological function.~      The IPSS also provides participating centers with the option to share de-identified patient~     CT and MRI's in the IPSS Imaging Repository housed at The Hospital for Sick Children in~     Toronto, Canada; incorporating a neuroimaging component would improve our understanding of~     the processes underlying plasticity and recovery in childhood stroke.~      Participating Investigators have the opportunity to access the larger dataset for use in~     group publications but each center will retain ownership of their own data. These~     contributing Investigators are recognized through authorship.~      The activities of the network are creating the opportunity for manuscript writing, grant~     development and collaboration on clinical challenges in paediatric stroke. Ultimately, this~     data will allow physicians to better diagnose, treat, and prevent stroke in children.~   "
265068|NCT00084214|"~     This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and~     paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma~     patients.~   "
265069|NCT00002682|"~     RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of~     the stomach. These treatments may also have an effect on gastric MALT lymphoma of the~     stomach.~      PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin,~     clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma~     of the stomach.~   "
265070|NCT00002676|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells and may be an~     effective treatment for non-Hodgkin's lymphoma.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and~     whole-brain radiation therapy in patients with primary central nervous system non-Hodgkin's~     lymphoma.~   "
265071|NCT00002670|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether radiation therapy plus cisplatin is more effective than~     radiation therapy alone in treating patients with head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus~     cisplatin with radiation therapy alone in treating patients with head and neck cancer that~     has been removed during surgery.~   "
265072|NCT00002656|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with pyrazoloacridine in~     treating patients with stage IIIB or stage IV non-small cell lung cancer.~   "
265073|NCT00002646|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining chemotherapy~     with hormone therapy may kill more tumor cells. Chemoprevention therapy is the use of certain~     drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may~     be an effective way to prevent the recurrence of breast cancer. It is not yet known whether~     tamoxifen plus fenretinide is more effective than tamoxifen alone for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen plus~     fenretinide with tamoxifen alone in treating postmenopausal women who have stage II or stage~     III breast cancer that is estrogen receptor positive and/or progesterone receptor positive.~   "
265074|NCT00002637|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells including natural killer~     cells to kill prostate cancer cells. Interferon gamma may interfere with the growth of the~     cancer cells. Combining interferon gamma with interleukin-2 may be a more effective treatment~     for prostate cancer.~      PURPOSE: Phase I/II trial to study the effectiveness of biological therapy using~     interleukin-2 and interferon gamma in treating patients with advanced prostate cancer.~   "
265075|NCT00002632|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with~     metastatic or recurrent salivary gland cancer.~   "
265076|NCT00002625|"~     Phase I trial to study the effectiveness of topotecan and radiation therapy in treating~     patients who have solid tumors or lymphoma. Drugs used in chemotherapy use different ways to~     stop cancer cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may~     kill more cancer cells.~   "
265077|NCT00002551|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not yet known which treatment regimen is more effective for rectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     combination chemotherapy plus radiation therapy in treating patients who have rectal cancer~     that has been surgically removed.~   "
265078|NCT00002538|"~     RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for ovarian,~     primary fallopian tube, and primary abdominal cancers.~      PURPOSE: Phase II trial to study the effectiveness of laparoscopic staging in patients with~     ovarian, primary fallopian tube, or primary abdominal cancers who have not undergone complete~     staging.~   "
265079|NCT00084201|"~     The purpose of study is to determine whether cranberry juice interacts with antibiotics used~     to treat urinary tract infections (UTIs).~   "
265080|NCT00084188|"~     The purpose of this study is to look at a program for women in drug abuse treatment designed~     to reduce Human Immunodeficiency Virus/Sexually Transmitted Disease (HIV/STD) risk behaviors~     and reduce unprotected sexual risk behavior.~   "
265081|NCT00084175|"~     The purpose of this study is to evaluate a five-session Human Immunodeficiency Virus/Acquired~     Immune Deficiency Disease (HIV/AIDS) group therapy designed specifically for heterosexual~     men. This therapy is compared to standard HIV/AIDS education, which generally consists of a~     single session of HIV education.~   "
265082|NCT00006451|"~     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy used to kill cancer cells.~      PURPOSE: Randomized phase II/III trial to determine the effectiveness of bone marrow~     transplantation in treating patients who have leukemia.~   "
265083|NCT00006387|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. QS21 may~     improve the ability of the immune system to respond to disease. Combining vaccine therapy~     with QS21 may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus QS21 in treating~     patients who have advanced pancreatic or colorectal cancer.~   "
265084|NCT00006382|"~     RATIONALE: New imaging procedures such as spiral CT may improve the ability to detect lung~     cancer in patients who are at high risk for the disease.~      PURPOSE: Randomized clinical trial to compare the effectiveness of a spiral CT scan with that~     of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.~   "
265085|NCT00006380|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have prostate cancer that no longer responds to antiandrogen therapy.~   "
265086|NCT00006378|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells~      PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens~     of combining paclitaxel and carboplatin plus radiation therapy in treating patients who have~     stage III non-small cell lung cancer that cannot be removed during surgery.~   "
265087|NCT00006374|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective for treating~     extensive-stage small cell lung cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combining topotecan and~     paclitaxel with that of combining etoposide and cisplatin in treating patients who have~     extensive-stage small cell lung cancer.~   "
265103|NCT00002496|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not yet known if chemotherapy plus radiation therapy is more effective than radiation~     therapy alone in treating patients with advanced cancer of the larynx.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without chemotherapy in treating patients with advanced cancer of the larynx.~   "
265104|NCT00002478|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients who have~     refractory, recurrent, or metastatic ovarian or cervical cancer.~   "
265088|NCT00006251|"~     This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and donor~     stem cell transplant followed by cyclosporine, mycophenolate mofetil, and donor lymphocyte~     infusion in treating patients with hematopoietic cancer. Giving low doses of chemotherapy,~     such as fludarabine phosphate, and total body irradiation (TBI) before a donor peripheral~     blood stem cell transplant helps stop the growth of cancer cells. It may also keep the~     patient's immune response from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte~     infusion) after the transplant may help increase this effect. Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.~   "
265089|NCT00005994|"~     RATIONALE: Patient education may improve the effectiveness of ondansetron in preventing~     nausea and vomiting in patients receiving chemotherapy.~      PURPOSE: This randomized clinical trial is studying how well patient education works in~     preventing nausea and vomiting in cancer patients receiving chemotherapy.~   "
265090|NCT00005790|"~     RATIONALE: Perfusion magnetic resonance imaging may be an effective method of measuring the~     growth of blood vessels in brain tumors. These measurements may help doctors better diagnose~     and treat brain tumors.~      PURPOSE: Pilot study to determine the effectiveness of perfusion magnetic resonance imaging~     in measuring the growth of blood vessels in newly diagnosed brain tumors.~   "
265091|NCT00005084|"~     RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability~     to determine the growth rate of progressive astrocytoma.~      PURPOSE: Phase II trial to study the effectiveness of magnetic resonance imaging in treating~     children who have progressive low-grade astrocytoma.~   "
265092|NCT00005045|"~     RATIONALE: Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow~     to the tumor.~      PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating~     patients who have advanced kidney cancer that has not responded to biological therapy.~   "
265093|NCT00004236|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating~     patients who have advanced stomach cancer.~   "
265094|NCT00003992|"~     Randomized phase II trial to study the effectiveness of chemotherapy with paclitaxel and the~     monoclonal antibody trastuzumab followed by chemotherapy in treating women who have stage II~     or stage IIIA breast cancer that overexpresses HER2. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can~     locate tumor cells and deliver tumor-killing substances to them without harming normal cells.~     Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.~   "
265095|NCT00003859|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not yet known whether undergoing surgery plus radiation therapy is more effective with or~     without chemotherapy for primitive neuroectodermal tumors of the CNS.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus radiation~     therapy with or without chemotherapy in treating patients who have primitive neuroectodermal~     tumors of the CNS.~   "
265096|NCT00003733|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of sequential chemotherapy in treating~     patients with residual disease following surgery for stage IIB, stage III, or stage IV~     ovarian cancer.~   "
265097|NCT00003584|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Prednisone~     may help to relieve symptoms in patients with recurrent and/or metastatic kidney cancer.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     vinorelbine and estramustine with or without prednisone in treating patients who have~     recurrent and/or metastatic kidney cancer.~   "
265098|NCT00003435|"~     RATIONALE: Antiviral agents are drugs that act against viruses and may be an effective~     treatment for HIV. Peripheral stem cell transplantation or umbilical cord blood~     transplantation may be able to replace immune cells that were destroyed by chemotherapy and~     radiation therapy used to kill tumor cells. Combining either umbilical cord blood~     transplantation or peripheral stem cell transplantation with antiviral therapy may be an~     effective treatment for HIV-positive patients who have hematologic cancer.~      PURPOSE: Phase I trial to study the effectiveness of antiviral therapy plus either peripheral~     stem cell transplantation or umbilical cord blood transplantation in treating HIV-positive~     patients who have refractory or recurrent hematologic cancer.~   "
265099|NCT00003410|"~     RATIONALE: New imaging procedures such as the use of gadolinium texaphyrin with MRI may~     improve the ability to detect the extent of gliomas.~      PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin used with~     MRI-guided surgery in treating patients with high-grade glioma.~   "
265100|NCT00003372|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with~     recurrent brain tumor.~   "
265101|NCT00003236|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase II trial to compare the effectiveness of ISIS 5132 with ISIS 3521~     in treating women who have metastatic breast cancer that has not responded to previous~     therapy.~   "
265102|NCT00002905|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with HIV-related non-Hodgkin's lymphoma that has relapsed or has not responded to~     chemotherapy.~   "
265131|NCT00083902|"~     The purpose of this investigational trial is to find out how well patients respond and how~     long their response lasts when treated with a standard regimen of dexamethasone with or~     without thalidomide and also find out what kind of side effects patients will experience.~   "
265105|NCT00002476|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known if radiation therapy plus chemotherapy is more effective than~     radiation therapy alone in treating patients with advanced head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without chemotherapy in treating patients with advanced head and neck cancer.~   "
265106|NCT00002460|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the uptake of estrogen.~      PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or~     ovarian ablation with goserelin or both in treating women with stage I or stage II breast~     cancer.~   "
265107|NCT00084162|"~     This study will examine how depression may influence the way the brain regulates heart~     function. Some researchers believe that depression may be a risk factor for some forms of~     heart disease.~      Right-handed healthy volunteers and patients with major depressive disorder who are between~     18 and 50 years of age may be eligible for this study. Female candidates must be~     premenopausal. Patients must currently be experiencing a major depressive episode. All~     candidates are screened with a medical history and physical examination, electrocardiogram,~     and blood and urine tests. They are interviewed about their psychiatric and medical history,~     current emotional state and sleep pattern, and family history of psychiatric disorders. They~     complete symptoms ratings scales for depression, anxiety, and negative thinking; history of~     alcohol and tobacco use; level of physical activity; socioeconomic status; overall level of~     functioning; and, for depressed patients, their depression type. Women candidates have their~     menstrual phase determined by the timing of their recent menstrual cycles and may undergo~     testing to determine the time of their ovulation.~      Participants undergo the following tests and procedures:~        -  12-minute walk/run test - This test measures the subject's general level of~          cardiorespiratory fitness. In a gymnasium in the NIH Clinical Center, the subject walks~          or runs as far as he or she can in 12 minutes. Blood pressure is measured before and~          after the exercise test, and heart rate is measured during exercise with a monitor worn~          around the chest.~        -  Magnetic resonance imaging (MRI) - A brain MRI scan is done to obtain pictures of the~          brain anatomy. Electrocardiogram leads are placed on the subject's chest to measure the~          electrical activity of the heart during the scanning session. The subject lies on a~          narrow bed in the scanner, which is a narrow metal cylinder about 6 feet long. The~          scanning session takes up to 90 minutes.~        -  Positron emission tomography (PET) - PET scanning produces images of the brain's blood~          flow. The subject is injected with a radiotracer (small amount of drug labeled with a~          radioactive substance) that is detected by a special camera to trace blood flow. During~          the scanning session, the subject lies still on a table. EKG leas are placed on the~          subject's chest to measure the electrical activity of the heart during the scan. A mask~          with holes for the eyes, ears, and mouth is placed over the subject's face to keep the~          head f...~   "
265108|NCT00084149|"~     Cyclosporine A (CsA) is a common long-term treatment used to inhibit the immune response in~     transplant patients who receive donor organs. CsA may also help people with HIV. The purpose~     of this study is to determine the safety of and immune response to CsA when given with~     abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/AZT) and lopinavir/ritonavir (LPV/r) to~     HIV infected adults in the early stages of infection.~      Study hypothesis: The combination of CsA and LPV/r given to acutely infected individuals will~     result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to~     acute infected individuals treated with LPV/r alone.~   "
265109|NCT00084136|"~     This study compared 3 different three-drug combinations in HIV infected individuals starting~     their first HIV treatment regimens. Participants were recruited from resource-limited areas~     in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis~     was each of the once daily combinations (PI based, or NNRTI based) would not have inferior~     efficacy compared to the twice daily NNRTI based combination.~   "
265110|NCT00084123|"~     The purpose of this study is to evaluate the effects of healing touch and relaxation therapy~     on cervical cancer patients undergoing chemotherapy and radiation treatment.~   "
265111|NCT00084110|"~     The purpose of this study is to examine complementary and alternative medicine use among~     older Mexican Americans and to determine how this use influences physical, functional, and~     mental health.~   "
265112|NCT00084071|"~     The purpose of this study is to determine whether tifacogin is effective and safe in the~     treatment of patients with severe community-acquired pneumonia.~   "
265113|NCT00083993|"~     In this clinical research study, postmenopausal subjects with metastatic breast cancer will~     be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and~     letrozole in first-line hormonal treatment. The primary endpoint of this study is to~     determine overall progression free survival.~      Individual subjects will participate in the active treatment phase of the study until disease~     progression or withdrawal of consent, provided that test article is being tolerated. All~     subjects will be asked to participate in the long-term follow-up phase of the study, which~     includes follow-up every 3 months until disease progression (for subjects who withdraw for~     reasons other than documented progressive disease) or until any new cancer treatment is~     received, and for survival. The estimated duration of study participation is 34 months.~   "
265114|NCT00005960|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have prostate cancer that has not responded to hormone therapy.~   "
265115|NCT00005641|"~     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Eliminating the T cells from the donor cells before transplanting them may prevent this from~     happening.~      PURPOSE: Phase II trial to study the effectiveness of T cell removal to prevent~     graft-versus-host disease in patients who are undergoing bone marrow transplantation from a~     donor.~   "
265116|NCT00005091|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have~     previously untreated stage IIIB or stage IV non-small cell lung cancer.~   "
265117|NCT00005054|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating women who have~     advanced breast cancer.~   "
265118|NCT00005050|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining eniluracil, fluorouracil,~     and oxaliplatin in treating patients who have advanced colorectal cancer that has been~     treated previously.~   "
265119|NCT00084097|"~     This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in~     reducing eosinophil counts and improving symptoms in patients with eosinophilic~     gastroenteritis (EG). EG is a disorder of unknown cause in which eosinophils, a type of white~     blood cell, are increased in the blood and gut tissue. Patients with EG have symptoms like~     stomach pain, bloating, and vomiting. About 50 percent of EG patients have food or~     environmental allergies, which may play a role in EG. Some patients with EG improve~     significantly on diets avoiding foods to which they are allergic. Immunoglobulin E (IgE) is~     an antibody that plays an important role in initiating allergic reactions. Omalizumab is a~     monoclonal antibody directed against IgE. The Food and Drug Administration approved~     omalizumab in 2003 for treating patients 12 years of age and older with allergic asthma.~      Patients between 12 and 76 years of age with eosinophilic gastroenteritis who have a blood~     eosinophil count of 500 or more and who have a food allergy or allergy to an inhaled allergen~     may be eligible for this study. Candidates are screened with a medical history, physical~     examination, and blood and urine tests.~      Participants undergo the following procedures:~        -  Leukapheresis. This procedure is done to collect quantities of white blood cells to~          study the effects of omalizumab on eosinophils and other immune substances. Blood flows~          from a needle placed in an arm vein through a catheter (plastic tube) into a machine~          that separates the blood into its components by centrifugation (spinning). Some of the~          white cells are removed and the rest of the blood (red cells, plasma and platelets) is~          returned to the body through a needle in the other arm.~        -  Skin testing. Participants are tested for allergies to specific substances. A small~          amount of various allergens (substances that cause allergies) are placed on the~          subject's arm. The skin is pricked at the sites of the allergens and the skin reaction~          after several minutes is observed.~        -  Upper and lower endoscopy. One or both of these procedures is done, depending on the~          part of the gastrointestinal tract that is involved, to examine the tract. If both~          procedures are done, they are performed at the same time. For the upper endoscopy, the~          subject's throat is sprayed with a numbing medicine and a long, flexible tube is passed~          through the esophagus, stomach and small intestine. For the lower endoscopy, the tube is~          passed through the rectum into t...~   "
265120|NCT00084084|"~     Primary Objective(s):~        -  To assess the safety of Replagal at a dose of 0.2 mg/kg administered over 40 (+/-10)~          minutes in children with Fabry disease~        -  To assess the effect of Replagal on heart rate variability in patients 7 to 17 years of~          age~      Secondary Objective(s):~        -  To determine the pharmacokinetics of Replagal at baseline and after the initiation of~          enzyme replacement therapy (ERT)~        -  To determine exploratory measurements of efficacy including renal function (ie,~          estimated glomerular filtration rate [eGFR] and creatinine clearance), clinical outcomes~          (in Cohorts 1 and 2), and sweating and left ventricular mass index (LVMI) (Cohort 1,~          Phase 1 only)~   "
265121|NCT00084058|"~     The purpose of this study is to determine the effect of increased doses of~     lopinavir/ritonavir (LPV/r) and saquinavir (SQV) in HIV infected children who are failing~     their current antiretroviral regimen~   "
265122|NCT00084045|"~     Voluntary HIV counseling and testing (VCT) and anti-HIV drugs for pregnant women and their~     newborns decrease rates of mother-to-child transmission (MTCT) of HIV. This study will~     determine the acceptability of HIV counseling and rapid testing prior to delivery and will~     compare the usefulness of VCT prior to birth versus after birth in preventing MTCT of HIV in~     pregnant women in Cape Town, South Africa. This study will also determine the acceptability~     and effectiveness of giving anti-HIV medications to prevent MTCT of HIV.~   "
265123|NCT00084032|"~     People recently infected with HIV who are treated with anti-HIV medications may develop~     strong immune system responses to HIV and may be able to control the virus without continuing~     to take these medications. The purpose of this study is to see if giving anti-HIV medications~     to people soon after they have been infected with HIV can help them control HIV. The study~     will also see if the immune system can control the amount of HIV virus in the blood (viral~     load) even after a person has stopped taking the medications. The study will evaluate three~     different schedules of stopping and starting anti-HIV medications to see which schedule is~     best able to boost a patient's immune system to control HIV viral load.~      Hypothesis: Combination therapy started in primary HIV infection, in conjunction with~     structured treatment interruptions, will result in greater control of viremia off treatment~     than induction therapy alone.~   "
265124|NCT00084019|"~     Long-term side effects, the expense of medications, and the difficulty of taking medications~     continuously for long periods of time are all problems with complicated anti-HIV drug~     regimens. The purpose of this study is to determine whether two drugs, atazanavir (ATV) and~     ritonavir (RTV), will control HIV infection when taken together without any other anti-HIV~     drugs after 48 weeks of viral suppression.~      Hypothesis: Simplified maintenance therapy with ATV and RTV alone after virologic suppression~     does not markedly increase the risk of virologic failure.~   "
265125|NCT00083980|"~     The purpose of this study is to evaluate the safety and effectiveness of the herbal medicine~     kava kava for the treatment of generalized anxiety disorder (GAD).~   "
265126|NCT00083967|"~     The purpose of this study is to test if denufosol will remove the fluid build-up in the eye~     so that the retina can be re-attached without invasive surgery.~   "
265127|NCT00083954|"~     The purpose of this study is to determine the efficacy of quetiapine compared to placebo in~     the treatment for a major depressive episode in patients with bipolar disorder after~     receiving treatment for up to 8 weeks.~   "
265128|NCT00083941|"~     The purpose of this study is to test the safety of an investigational vaccine called TroVax~     when given in conjunction with Interleukin-2 (IL-2) treatment. TroVax is the experimental~     product in this trial and its value as a medicine has not yet been proven. Interleukin-2~     (IL-2) is standard treatment for your cancer, which means that you could receive it even if~     you choose not to participate in this study. TroVax is being studied as a possible treatment~     for patients with cancer of the kidney.~      TroVax belongs to a class of medicines called a vaccine. A vaccine helps the body's immune~     system to recognize and kill foreign invading organisms effectively. It is believed that one~     of the reasons why cancer can spread through the body is that the immune system cannot~     recognize them as being different from normal tissues and therefore cannot kill the cancer~     cells. A vaccine that alerts the immune system to the presence of cancer cells in the body~     could lead to the immune system being able to target and kill those cancer cells effectively.~     This trial is of a completely new way of trying to treat cancer in the future by the use of~     vaccination injections. TroVax consists of a virus that has been changed so that it is no~     longer infectious and carries a gene for a protein called 5T4. This protein is carried by~     many kidney cancer calls. When the virus is injected, it makes the protein, and the body's~     immune system is then able to recognize this protein and kill the cells that have it (i.e.~     the cancer cells).~      The purpose of this study is to assess the safety and tolerability of TroVax injections and~     to understand whether TroVax could make such an immune response happen in patients with renal~     cell cancer while receiving Interleukin-2 (IL-2). This study will also observe and monitor~     any side effects experienced in patients who receive TroVax while being treated with IL-2.~   "
265129|NCT00083928|"~     The purpose of this study is to determine whether injections of Å6 are effective in treating~     ovarian cancer patients who have completed first-line therapy and currently have no~     detectable cancer but have experienced a doubling of CA 125 levels.~   "
265130|NCT00083915|"~     The purpose of this study is to find out if transplant with a new regimen of chemotherapy~     called DT PACE-Melphalan is better than transplant with Melphalan alone. DT-PACE refers to a~     chemotherapy regimen for multiple myeloma consisting of Dexamethasone, Thalidomide, Cisplatin~     or Platinol, Adriamycin or doxorubicin, Cyclophosphamide, and Etoposide. Another purpose of~     this study is to find out if there will be fewer side effects with the new regimen of DT~     PACE-Melphalan, compared to melphalan alone.~   "
265134|NCT00083863|"~     To investigate the contribution of genetic and environmental factors to vascular~     inflammation, and to define the extent to which inflammatory phenotypes and genotypes predict~     subclinical and clinical cardiovascular disease (CVD).~   "
265135|NCT00083850|"~     To evaluate the effects of genetic variants in all of the nine adrenergic receptor subtype~     genes, alone or in combination, on cardiovascular reactivity and other quantitative~     cardiovascular traits in a population of 1048 healthy young twins.~   "
265136|NCT00083837|"~     To test whether specific genes affect lipoprotein and weight responses to vigorous exercise~     in identical twins.~   "
265137|NCT00083824|"~     To clarify the effects of estrogen, with or without progestin, on high density lipoprotein~     (HDL) in postmenopausal women.~   "
265138|NCT00083811|"~     To investigate the role of genetics in cardiorespiratory fitness, obesity, and risk of~     hypertension.~   "
265139|NCT00083798|"~     To study the genetic basis of obstructive sleep apnea using a genealogical approach.~   "
265140|NCT00005032|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Bcl-2 antisense oligodeoxynucleotide G3139 may increase the~     effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.~      PURPOSE: Phase I/II trial to study the effectiveness of bcl-2 antisense oligodeoxynucleotide~     G3139 and paclitaxel in treating patients who have recurrent small cell lung cancer.~   "
265141|NCT00005030|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase I trial to compare the effectiveness of different doses of SCH~     66336 before surgery in treating patients who have colorectal cancer that has metastasized to~     the liver.~   "
265142|NCT00004979|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining topotecan and paclitaxel in~     treating patients who have advanced non-small cell lung cancer or other advanced solid~     tumors.~   "
265143|NCT00004927|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have~     advanced solid tumors that have not responded to previous therapy.~   "
265144|NCT00004877|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of BMS-214662 in treating patients who have~     advanced solid tumors.~   "
265145|NCT00004161|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of or treat early cancer. Fenretinide may be an effective drug in treating~     leukoplakia.~      PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide in treating~     patients who have leukoplakia of the mouth.~   "
265146|NCT00004146|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining~     radiation therapy with chemotherapy may kill more tumor cells. Phase II trial to study the~     effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have~     newly diagnosed supratentorial glioblastoma multiforme.~   "
265147|NCT00004071|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if mitoxantrone and prednisone are more effective with or without leflunomide for~     treating prostate cancer.~      PURPOSE: Randomized phase II/III trial to compare the effectiveness of mitoxantrone and~     prednisone with or without leflunomide in treating patients who have stage IV prostate cancer~     that has not responded to hormone therapy.~   "
265148|NCT00004070|"~     Participant with squamous cell cancer of head and neck are invited to participate in this~     study. In this study the investigators will be Inserting the gene for interleukin-12 into a~     person's cancer cells with the anticipation to make the body build an immune response to kill~     more tumor cells.~   "
265149|NCT00004062|"~     RATIONALE: Azacitidine may help thyroid cancer cells regain the ability to take up iodine.~     This would allow the cancer to be detected and treated by radioactive iodine.~      PURPOSE: Phase I trial to study the effectiveness of azacitidine to restore thyroid function~     in treating patients who have persistent or metastatic thyroid cancer.~   "
265150|NCT00083785|"~     The purpose of this study is to determine whether the Litx™ system is safe and effective in~     combination with chemotherapy in the treatment of liver metastasis arising from colorectal~     cancer. Litx™ is a next-generation photodynamic therapy platform in which the drug,~     talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based~     light infusion device, inserted directly into the tumor through the skin prior to treatment.~   "
265151|NCT00083772|"~     Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV)~     filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of~     patients admitted with acute diastolic heart failure.~      Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in~     Doppler diastolic filling parameters in patients with diastolic heart failure.~   "
265152|NCT00083759|"~     The purpose of this study is to determine the safety, tolerability and efficacy of~     natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving~     concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the~     movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells~     are thought to cause damage in the joints leading to the symptoms of RA.~   "
265153|NCT00004055|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of topotecan, paclitaxel, and filgrastim~     in treating patients who have previously untreated extensive-stage small cell lung cancer.~   "
267661|NCT00063622|"~     The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead~     to an improvement in liver histology in non-diabetic adult patients with non-alcoholic~     steatohepatitis (NASH).~   "
265154|NCT00003998|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which combination chemotherapy regimen is more effective for treating ovarian~     epithelial cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus~     paclitaxel with that of carboplatin plus docetaxel in treating patients who have ovarian~     epithelial cancer.~   "
265155|NCT00003997|"~     Phase I trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients~     who have refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic~     leukemia, or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy use~     different ways to stop cancer cells from dividing so they stop growing or die.~   "
265156|NCT00003991|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myeloid~     leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of~     relapse in patients with acute myeloid leukemia in remission.~      PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus~     histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in~     remission following previous therapy.~   "
265157|NCT00003939|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients~     who have advanced soft tissue sarcoma.~   "
265158|NCT00003856|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill tumor cells. This may be an effective palliative treatment for head and neck~     cancer.~      PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy for palliative~     treatment in patients who have recurrent, refractory, or second primary head and neck cancer~     that cannot be treated with surgery or radiation therapy.~   "
265159|NCT00003850|"~     Phase II trial to study the effectiveness of thalidomide in treating patients with recurrent~     or metastatic head and neck cancer. Thalidomide may stop the growth of head and neck cancer~     by stopping blood flow to the tumor.~   "
265160|NCT00003787|"~     RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer~     recurrence.~      PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in~     vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage~     II, or stage III breast cancer.~   "
265161|NCT00003773|"~     RATIONALE: IM-862 may stop the growth of ovarian cancer by stopping blood flow to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of IM-862 in treating patients who have~     recurrent ovarian cancer after treatment with chemotherapy and surgery.~   "
265162|NCT00003758|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.~   "
265163|NCT00003755|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of Ro 31-7453 in treating patients who have~     locally advanced or metastatic solid tumor.~   "
265164|NCT00003740|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who~     have prostate cancer that has not responded to hormone therapy.~   "
265165|NCT00003443|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with~     metastatic or recurrent head and neck cancer.~   "
265166|NCT00003401|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation~     plus combination chemotherapy in treating patients who have multiple myeloma that has been~     treated for longer than 12 months.~   "
265167|NCT00003399|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation~     plus combination chemotherapy in treating patients who have multiple myeloma.~   "
265168|NCT00003396|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy used to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation~     from related donors to prevent graft-versus-host disease in treating patients with~     hematologic cancer.~   "
265169|NCT00003293|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether SU-101 is more effective than~     procarbazine in treating patients with glioblastoma multiforme.~      PURPOSE: Randomized phase III trial to compare the effectiveness of SU-101 with that of~     procarbazine in treating patients with glioblastoma multiforme that has recurred.~   "
265170|NCT00003249|"~     Phase I trial to study the effectiveness of carboxyamidotriazole and ketoconazole in treating~     patients with advanced cancers. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Combining more than one drug may kill more~     tumor cells.~   "
265171|NCT00003231|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug with surgery may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with docetaxel~     and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung~     cancer.~   "
272219|NCT00002128|"~     To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA~     (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.~   "
265172|NCT00083720|"~     This is a phase II, multicenter, open-label study of cetuximab in patients with epidermal~     growth factor receptor (EGFR) negative, metastatic colorectal carcinoma who have progressed~     after receiving at least one standard chemotherapeutic regimen that included a~     fluoropyrimidine. Target enrollment is 80 evaluable patients.~      Patients with EGFR-negative metastatic colorectal carcinoma who have progressed after~     receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine,~     will receive an initial dose of cetuximab, 400 mg/m2 , intravenously (i.v.) over 120 minutes,~     followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who~     experience unacceptable toxicity or who have progressive disease (PD) will not receive~     further cetuximab therapy.~      Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on~     cetuximab therapy. Patients with stable disease (SD), partial response (PR), or a complete~     response (CR) may continue to receive weekly cetuximab therapy, unless they are dose-delayed~     or discontinued because of toxicity. Patients who have a PR or CR must have a confirmatory~     tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.~     To evaluate the objective response rate, a single-stage design will be used in this study.~   "
265173|NCT00083733|"~     This study will collect, analyze, and compare genes and proteins in normal breast tissue with~     those in various tissues from women with breast cancer to look for changes that are unique to~     breast cancer cells. Information about these differences may lead to more effective breast~     cancer treatments with fewer side effects. The study has the following objectives:~        -  To define the molecular (genetic and protein) profile of normal breast tissue from pre-~          and post-menopausal women of different ages and who have had varying numbers of children~          (or no children), and who are in different phases of the menstrual cycle~        -  To define the molecular profile of primary breast tumors and tumors that have~          metastasized (spread) beyond the primary site~        -  To characterize breast cancer stem cells and establish cell lines from the pleural fluid~          (fluid around the lungs) of women with metastatic breast cancer. (A cell line is a~          collection of cells that are grown in the laboratory from an original tissue specimen.)~      The following women may be eligible for this study:~        -  Women who are undergoing cosmetic breast surgery that requires removal of some breast~          tissue (e.g., breast reduction surgery)~        -  Women 18 years of age or older who are undergoing a biopsy or other surgical procedure~          to sample or remove a known or suspected primary or metastatic breast tumor~        -  Women 18 years of age or older who are undergoing pleurocentesis, a procedure to remove~          fluid from around the lung that is suspected or known to be caused by spread of breast~          cancer~      Participants undergo the required procedure (e.g., surgery, biopsy, or pleurocentesis) and~     provide information that may include the following:~        -  Age, race/ethnicity~        -  Age at first menstrual period (menarche)~        -  Age at first pregnancy and age when the first child was born~        -  Age at menopause~        -  Information about primary breast cancer~        -  Family history of breast cancer~        -  Information on previous breast biopsies, if any, and hormones taken (birth control pills~          or hormone replacement therapy), if any~        -  Copy of pathology report from procedure (surgery, biopsy, or pleurocentesis)~   "
265174|NCT00083707|"~     The purpose of this research is to study how helpful thalidomide is in controlling the~     disease and to study any side effects from taking thalidomide.~   "
265175|NCT00083694|"~     The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients~     with leukemia.~   "
265176|NCT00083681|"~     The purpose of this investigational trial is to find out how well patients respond and how~     long their response lasts when treated with a four day chemotherapy regimen involving~     dexamethasone, cytoxan, etoposide, and cisplatinum, or DCEP with or without thalidomide.~     Another purpose is to find out what kind of side effects patients will experience.~   "
265177|NCT00083668|"~     The primary objective of the double-blind phase of this study is to evaluate the efficacy and~     safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in~     adult patients with schizophrenia~   "
265178|NCT00083616|"~     The purpose of this study is to determine that panitumumab will have clinically meaningful~     anti-tumor activity in patients with metastatic colorectal cancer who have developed~     progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and~     oxaliplatin chemotherapy.~   "
265179|NCT00083564|"~     STR (Skeletal Targeted Radiotherapy, 166Ho-DOTMP) is an investigational radiopharmaceutical~     that delivers radiation directly to cancer cells in the bone and bone marrow. Conventional~     methods of delivering radiation therapy, such as total body irradiation, expose non-target~     tissues to radiation and cause serious side effects. In contrast, STR's targeted approach to~     delivering radiotherapy concentrates the radiation where it is needed, and minimizes exposure~     of normal tissues.~      STR is composed of a bone-targeting molecule, DOTMP, in a stable complex with the~     radionuclide holmium-166. When injected into a patient's bloodstream, STR rapidly binds to~     bone mineral, delivering a brief, intense dose of radiation to destroy cancer cells in the~     bone and marrow. The high-energy and long path-length of holmium-166 beta particles provide~     optimal penetration and uniform irradiation of disease sites in the marrow and bone. STR that~     does not bind to bone is rapidly eliminated through the urinary tract. STR treatment is~     followed by autologous stem cell transplantation. The short half-life of holmium-166 allows~     treatment on an out-patient basis, and minimizes the time required between STR administration~     and transplantation.~      The phase III study of STR is a multi-center, randomized, controlled study, designed to~     evaluate the safety and efficacy of STR in patients with primary refractory multiple myeloma.~     These are patients who have failed to achieve at least a partial response to conventional~     therapy and have been undergoing treatment for less than 18 months. The trial is expected to~     enroll approximately 240 evaluable patients, half on the experimental arm and half on the~     control arm. Patients on the experimental arm will receive STR at a dose of 750 mCi/m2 plus~     the chemotherapy drug melphalan at 200 mg/m2, followed by autologous stem cell~     transplantation. Patients on the control arm will receive melphalan only, followed by~     transplantation. Patients on both study arms will be evaluated for response to treatment six~     months after transplantation, using an immunofixation assay to detect myeloma protein in~     patient samples. Analysis of patient samples will be conducted at a central laboratory, and~     blinded results will be reviewed by an independent panel of experts. The study's primary~     endpoint is complete response, as determined by the complete disappearance of myeloma protein~     at six months post-transplant.~   "
265180|NCT00083642|"~     This study will determine how people who have had a stroke learn to perform a movement by~     observation, as compared with people who have not had a stroke. Normally, a person learns a~     new hand movement automatically by observing the movement performed by others. Improvement~     with practice also relies on visual feedback. This observational training - i.e., the~     repeated observation of a movement - is sufficient for normal individuals to learn a~     movement. This study will examine brain activity related to motor learning in stroke patients~     and in healthy control subjects to see whether stroke patients process visual-motor~     information the same way normal subjects do.~      Normal volunteers and stroke patients between 18 and 75 years of age may be eligible for this~     study. Patients must have had paralysis on one side of the body due to a stroke that occurred~     at least 3 months before entering the study. Candidates who have not had a recent health~     screening will have a clinical and neurological examination.~      Participants undergo the following procedures:~        -  Brain magnetic resonance imaging (MRI), if one has not been done recently. This test~          uses a strong magnetic field and radio waves to obtain images of body organs and~          tissues. The subject lies on a table that can slide in and out of the cylindrical~          scanner and wears earplugs to muffle loud noises caused by switching of magnetic fields.~          Scanning time varies from 20 minutes to 3 hours, with most sessions lasting 45 to 90~          minutes.~        -  Task training. The subject practices the task to be performed during functional MRI (see~          below). The subject makes finger tapping movements, then watches finger movements on a~          video screen for several minutes, during which time the movie stops from time to time~          without warning. When the movie stops, the subject must reproduce the last finger~          movement that appeared on the screen. During this session, the electrical signals of the~          subject's forearm muscles are recorded at the skin surface. This session lasts up to 3~          hours.~        -  Functional MRI. The subject undergoes MRI scanning while performing the same tasks done~          in the training session. This session lasts about 3 hours.~   "
265212|NCT00005578|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal~     cells from the side effects of chemotherapy.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without dexrazoxane in treating children who have Hodgkin's disease.~   "
265181|NCT00083629|"~     This study will examine the use of a new radioactive tracer called [18F]FECNT in positron~     emission tomography (PET) scanning for measuring dopamine transporter (DAT) in the brain. DAT~     is found in brain neurons (nerve cells) that release the chemical messenger dopamine. By~     taking pictures of the DAT, scientists hope to learn more about the function of these~     neurons.~      Normal, healthy volunteers between 18 and 65 years of age may be eligible for this study.~     Candidates are screened with a medical history and physical examination, psychological~     assessment, and blood and urine tests.~      Subjects enrolled in the study participate in one of the following procedures:~      Brain Imaging Study: Part 1~      Two catheters (small plastic tubes) are placed into veins in the subject's arms for injecting~     [18F]FECNT and for collecting blood samples during the scan. A third catheter is placed into~     a wrist artery to obtain arterial blood during the scan. With the catheters in place, the~     subject lies down on the scanner bed with his or her head placed in a special mask that~     limits movement during the brain scan. The scan begins with an initial x-ray like picture for~     about 10 minutes, after which the [18F]FECNT is injected and the actual PET scan starts. The~     entire procedure takes about 6 hours, including 2 hours of continuous scanning sessions,~     during which the subject is required to lie still. Subjects can relax out of the scanner~     between scans. They are monitored throughout the procedure. Vital signs are measured and~     electrocardiogram is taken once before and twice after injection of the tracer. At the end of~     the scanning, additional blood and urine samples are collected. Subjects are asked to urinate~     every 2 hours to lessen the radioactivity in the body.~      Whole Body Imaging Study: Part 2~      For this procedure, a catheter is placed in a vein for injecting the [18F]FECNT tracer. A~     total of five scans are taken, each one spanning from head to upper thigh. During the course~     of the scans, x-ray like pictures are obtained. The first scan takes about 100 minutes. Four~     additional 1-hour scans are done every 100 minutes. The total time for the scans is about 6~     hours, and the total time for the entire procedure is about 9 hours. About 2 tablespoons of~     blood are drawn by needle stick at one time during the imaging. Subjects can leave the PET~     scanner between scans. They are asked to urinate every 2 hours for 6 hours from the time of~     tracer injection and to collect all the urine so that radioactivity can be measured.~      Brain Imaging Study: Part 3~      Part 3 of the study is the same as Part 1, except that two PET procedures are done on~     separate days, the second within 4 weeks of the first. In addition, participants may also~     under magnetic resonance imaging (MRI) scanning, a test that uses magnetic fields and radio~     waves to obtain pictures of the brain.~   "
265182|NCT00083603|"~     The purpose of this study is to evaluate the safety of and immune response to two HIV vaccine~     formulations, rMVA-HIV and rFPV-HIV, alone and in combination, in HIV uninfected adults.~   "
265183|NCT00083590|"~     The present study will evaluate the safety and efficacy of the Chinese herb huperzine A in~     the treatment of Alzheimer's disease (AD) in a randomized controlled trial of its effect on~     cognitive function.~   "
265184|NCT00083577|"~     The purpose of this research is to study how helpful thalidomide is in controlling the~     myeloma disease and to study any side effect resulting from thalidomide.~   "
265185|NCT00083551|"~     This study has been designed to evaluate whether anti-angiogenesis therapy with thalidomide~     and whether additional chemotherapy after transplant will be beneficial. Another objective is~     to find out what kinds of side effects occur with this combination of treatment and how often~     they occur.~   "
265186|NCT00083538|"~     The purpose of this study is to determine if vaccination with autologous idiotype- or tumor~     lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor~     immunologic responses.~   "
265187|NCT00083486|"~     The purpose of this study is to determine the effectiveness of different doses of epoetin~     alfa for treating anemia in patients who have cancer; or patients who no longer have any~     signs of cancer, but remain anemic as a result of their treatment. These patients should not~     be currently receiving chemotherapy or radiotherapy. A subject's participation in the study~     will last approximately 6 months. Subjects will receive weekly doses of epoetin alfa or~     placebo. Their hemoglobin will be tested every week.~   "
265188|NCT00003160|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving the drugs in different ways may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage~     III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens.~   "
265189|NCT00003079|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 and high dose cytarabine in~     treating patients with refractory or relapsed acute myelocytic or acute lymphocytic leukemia,~     chronic myelogenous leukemia or refractory or relapsed lymphoblastic lymphoma.~   "
265190|NCT00003075|"~     RATIONALE: Chemoprevention uses drugs to try and prevent development of cancer. Fenretinide~     may be effective in treating cervical neoplasia and preventing cervical cancer.~      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of~     fenretinide to placebo in treating patients with cervical neoplasia.~   "
265191|NCT00003031|"~     RATIONALE: Antifungal therapy with voriconazole or amphotericin B may be an effective~     treatment for aspergillosis. It is not yet known whether voriconazole is more effective than~     amphotericin B in treating patients with aspergillosis.~      PURPOSE: Randomized phase III trial to compare the effectiveness of voriconazole with~     amphotericin B in treating patients with aspergillosis.~   "
265192|NCT00003015|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus~     vincristine in treating children and adolescents with low grade glioma.~   "
265193|NCT00083525|"~     The purpose of this study is to determine the safety, tolerability, maximum tolerated dose~     (MTD), pharmacokinetics, and pharmacodynamics of the combination of WX-UK1 and capecitabine~     in patients with advanced malignancies.~   "
265194|NCT00083473|"~     This pilot study will assess the safety and efficacy of Pivanex alone in patients with~     chronic lymphocytic leukemia (CLL) who have relapsed or refractory disease after previous~     chemotherapy treatment. Pivanex is an investigational agent.~   "
265195|NCT00083460|"~     The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses~     of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate~     doses of PS-341 and thalidomide in the combination.~   "
265213|NCT00005088|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cisplatin in~     treating patients who have advanced head and neck cancer.~   "
265214|NCT00005069|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have metastatic kidney cancer.~   "
267763|NCT00062634|"~     The female condom offers women a potentially important option for HIV prevention. This study~     will develop and evaluate a health education program to increase female condom use among~     ethnically diverse women.~   "
265196|NCT00083447|"~     TransMID treatment or best standard of care for patients with advanced glioblastoma~     multiforme~      Glioblastoma multiforme (GBM) is a type of brain tumour. GBM tumours are usually treated with~     surgery and radiotherapy. Unfortunately, this type of brain tumour may continue to grow or~     come back (recur) despite treatment.~      This trial will compare a new drug called TransMID with the best standard treatment that is~     currently available. TransMID is a drug that is a combination of a protein called transferrin~     and a poison called diphtheria toxin.~      Cancer cells need iron in order to continue to grow. They need more iron than normal cells.~     Transferrin helps cells to take up available iron. So the cancer cells are attached to the~     transferrin in TransMID, and the diphtheria poison kills them. The aim of this treatment is~     to kill the cancer cells while not affecting the normal brain cells. This treatment for brain~     tumours may have fewer side effects than other treatments because it targets cancer cells.~      The best standard treatment will involve giving chemotherapy. You may have chemotherapy as~     part of the treatment when you are diagnosed. Or it may be kept in reserve to treat your~     brain tumour if it comes back or continues to grow. Your cancer specialist (consultant) will~     decide which chemotherapy drugs you should have.~   "
265197|NCT00083434|"~     The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia~     in patients who have cancer or who no longer have any signs of the cancer, but remain anemic~     as a result of their treatment.~   "
265198|NCT00006877|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have metastatic non-small cell lung cancer.~   "
265199|NCT00006358|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to~     the tumor.~      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide~     in treating patients who have recurrent or progressive brain tumor.~   "
265200|NCT00006343|"~     RATIONALE: Biological therapies such as interferon-alfa and STI571 may interfere with the~     growth of cancer cells. It is not yet known if STI571 is more effective than interferon alfa~     plus cytarabine for chronic myelogenous leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of STI571 with that of~     interferon alfa plus cytarabine in treating patients who have newly diagnosed chronic~     myelogenous leukemia.~   "
265201|NCT00006222|"~     Phase I trial to study the effectiveness of EMD 121974 in treating patients who have~     HIV-related Kaposi's sarcoma. EMD 121974 may stop the growth of Kaposi's sarcoma by stopping~     blood flow to the tumor.~   "
265202|NCT00006212|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Drugs such as phosphorus-32 may make the tumor cells more sensitive to radiation therapy.~     Chemotherapy combined with radiation therapy and phosphorus-32 may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of phosphorus-32 plus radiation therapy and~     chemotherapy in treating patients who have stage II or stage III non-small cell lung cancer.~   "
265203|NCT00006083|"~     RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a~     catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is~     effective in reducing these complications.~      PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in~     preventing catheter-related complications in cancer patients who are receiving chemotherapy~     through a catheter.~   "
265204|NCT00006079|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of eflornithine may be an effective way to~     prevent the recurrence of or further development of cervical cancer.~      PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in~     preventing cervical cancer in patients who have cervical intraepithelial neoplasia.~   "
265205|NCT00006001|"~     Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic~     or locally recurrent colorectal cancer. SU5416 may stop the growth of colorectal cancer by~     stopping blood flow to the tumor.~   "
265206|NCT00005942|"~     Phase I/II trial to study the effectiveness of liposomal daunorubicin and SU5416 in treating~     patients who have hematologic cancer that has not responded to initial therapy. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. SU5416 may stop the growth of hematologic cancer by stopping blood flow to the cancer~   "
265207|NCT00005939|"~     RATIONALE: Radiation therapy uses high-energy radiation to damage tumor cells. Brachytherapy~     uses radioactive material that is placed directly into or near the tumor. Brachytherapy may~     kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating patients~     who have recurrent prostate cancer that has not responded to standard therapy.~   "
265208|NCT00005841|"~     RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to~     kill tumor cells. Vaccine therapy plus filgrastim combined with a specific protein may be a~     more effective treatment for melanoma.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with stage III or stage IV melanoma that has been completely removed during~     surgery.~   "
265209|NCT00005645|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ILX-295501 in treating patients who~     have stage III or stage IV ovarian cancer that has not responded to previous therapy.~   "
265210|NCT00005640|"~     RATIONALE: Diagnostic procedures, such as lymph node mapping and biopsy, may improve the~     ability to detect the extent of colorectal cancer.~      PURPOSE: Diagnostic trial to study the feasibility of lymph node mapping and sentinel lymph~     node biopsy in patients who have stage I, stage II, or stage III colorectal cancer.~   "
265211|NCT00005636|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if cisplatin is more effective with or without~     pemetrexed disodium for malignant mesothelioma of the pleura.~      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without~     pemetrexed disodium in treating patients who have malignant mesothelioma of the pleura that~     cannot be removed by surgery.~   "
265215|NCT00005059|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating~     patients who have metastatic or recurrent unresectable non-small cell lung cancer.~   "
265216|NCT00002923|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to evaluate the effectiveness of KRN5500 in treating patients with~     metastatic solid tumors.~   "
265217|NCT00002917|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel in treating patients with~     early-stage bladder cancer.~   "
265218|NCT00002911|"~     RATIONALE: Marimastat may stop the growth of non-small cell lung cancer by stopping blood~     flow to the tumor.~      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of~     marimastat in treating patients who have residual stage III non-small cell lung cancer.~   "
265219|NCT00002829|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells, and may be an effective treatment for lymphoma. Bone marrow transplantation may be~     able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to~     kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating~     patients with recurrent or residual low-grade lymphoma.~   "
265220|NCT00002827|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not~     yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's~     disease.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy,~     with or without dexrazoxane, followed by radiation therapy in treating young patients with~     newly diagnosed stage I, stage II, or stage III Hodgkin's disease.~   "
265221|NCT00002819|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune~     cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It~     is not yet known whether chemotherapy alone is more effective than chemotherapy plus~     peripheral stem cell transplantation for ovarian epithelial cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and~     carboplatin with that of carboplatin, mitoxantrone, and cyclophosphamide followed by~     peripheral stem cell transplantation in treating patients who have persistent stage III or~     stage IV ovarian epithelial cancer.~   "
265222|NCT00002806|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of procarbazine, lomustine, and~     vincristine followed by radiation therapy in treating adults who have supratentorial glioma.~   "
265223|NCT00002721|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus estramustine in~     treating patients with metastatic recurrent prostate cancer that does not respond to hormone~     therapy.~   "
265224|NCT00002639|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with~     recurrent primary brain tumors following radiation therapy.~   "
265225|NCT00002602|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an~     effective treatment for prostate cancer.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating~     patients who have previously untreated stage II or stage III prostate cancer.~   "
265226|NCT00002555|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known if radiation therapy plus chemotherapy is more effective than~     radiation therapy alone in treating patients with head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation~     therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head~     and neck cancer who have undergone surgery to remove the cancer.~   "
265227|NCT00002477|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant therapy using~     platinum-based chemotherapy drugs with no adjuvant therapy in treating patients with early~     stage invasive ovarian epithelial cancer.~   "
265228|NCT00083512|"~     This study will collect blood and urine samples from patients undergoing radiation therapy~     for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this~     treatment on blood cells and certain proteins. The information from this study may help~     scientists develop new tests to measure radiation exposure and find new ways to treat cancer~     with radiation, and help determine which kinds of patients or tumors respond better to~     radiation therapy. Two proteins of particular interest in this study and which may be~     involved in the recurrence of cancer are VEGF (vascular endothelial growth factor) and MMPs~     (matrix metalloproteinases).~      Patients 18 years of age and older with glioblastoma multiforme who are receiving or will~     receive radiation therapy as part of their medical treatment may be eligible for this study.~     Candidates are screened with a history and physical examination, blood tests, and magnetic~     resonance imaging (MRI) of the brain.~      Participants will have blood and urine samples collected before, during and after completion~     of their radiation treatment. Urine samples are collected in a cup and about 2 tablespoons of~     blood are withdrawn through a needle in a vein. Additional samples may be requested at~     different times during treatment and in the 3-year follow-up period.~   "
265229|NCT00083499|"~     This study will collect blood, urine, and other tissue samples from patients with Pentalogy~     of Cantrell (POC) and other inherited diseases that may involve mutations in non-muscle~     myosin II-B heavy chain (MYH10). We will also collect samples from the relatives of affected~     individuals. POC is a very rare disorder in which patients have a combination of severe~     defects of the middle of the chest including the sternum (breastbone), diaphragm, heart, and~     abdominal wall. The defect are apparent before birth or at birth.~      Participants may undergo a medical evaluation that could include a medical history routine~     blood tests, urine collection, chest x-ray, and electrocardiogram. In addition, blood, urine,~     saliva, buccal swab or tissue samples may be collected for protein and gene studies. The~     blood is drawn through a very small needle placed in an arm vein. Children may choose to have~     a buccal (cheek) sample taken instead of blood draw. Buccal samples can be collected by a~     cheek swab, in which a soft brush is rubbed on the inside lining of the mouth, or by having~     the child hold a tablespoon of mouthwash in his or her mouth for a full minute and then spit~     the mouthwash into a container. In addition, tissue samples may be collected from patients if~     they undergoing any surgical procedures that may be required as part of their general medical~     care.~      Some of the cells obtained from patients or their relatives may be used to establish cell~     lines (a living tissue sample) that can be grown in the laboratory and used for experiments.~   "
265230|NCT00083408|"~     The purpose of this research is to study how helpful the combination of thalidomide and~     Pamidronate is in controlling multiple myeloma and to study any side effects that may be~     experienced.~   "
265231|NCT00004881|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have advanced cancer.~   "
265232|NCT00004200|"~     RATIONALE: Prinomastat may stop the growth of glioblastoma multiforme by stopping blood flow~     to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing~     or die.~      PURPOSE: Randomized phase II trial to study the effectiveness of prinomastat plus~     temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.~   "
265233|NCT00004190|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and oxaliplatin~     in treating patients who have refractory locally advanced or metastatic pancreatic cancer.~   "
265234|NCT00004176|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and~     radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of amifostine plus chemotherapy and~     radiation therapy in treating patients who have limited-stage small cell lung cancer.~   "
265235|NCT00004139|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to compare the effectiveness of gemcitabine plus either docetaxel or~     irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
265236|NCT00004112|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer~     cells and either kill them or deliver cancer-killing substances to them without harming~     normal cells. It is not yet known whether combination chemotherapy plus rituximab is more~     effective than combination chemotherapy alone for non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without rituximab in treating patients who have newly diagnosed non-Hodgkin's~     lymphoma that has not been treated previously.~   "
265237|NCT00004105|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vinorelbine, paclitaxel, and~     estramustine in treating patients who have advanced cancer that has not responded to previous~     treatment.~   "
265238|NCT00004061|"~     RATIONALE: Biological therapy using growth factors may be effective in reducing side effects~     in patients who have hematologic cancer and are receiving radiation therapy, chemotherapy,~     and peripheral stem cell transplantation.~      PURPOSE: Randomized phase II trial to study the effectiveness of biological therapy to reduce~     side effects in patients who are undergoing radiation therapy, chemotherapy, and peripheral~     stem cell transplantation in treating lymphoma or leukemia.~   "
265239|NCT00004030|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of VX-853 in treating patients who have~     solid tumors who are receiving liposomal doxorubicin.~   "
265240|NCT00004012|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who~     have recurrent ovarian, fallopian tube, or primary peritoneal cancer.~   "
265241|NCT00003985|"~     RATIONALE: Biological therapies such as KRN7000 use different ways to stimulate the immune~     system and stop cancer cells from growing.~      PURPOSE: Phase I trial to study the effectiveness of KRN7000 in treating patients who have~     solid tumors that have not responded to previous treatment.~   "
265242|NCT00003984|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have primary myelodysplastic syndrome.~   "
265243|NCT00003982|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating patients who have~     solid tumors.~   "
265244|NCT00003980|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of BIBX 1382 in treating patients who have~     solid tumors.~   "
265245|NCT00003944|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients who have stage III or stage IV~     ovarian, fallopian tube, or primary peritoneal cancer.~   "
265246|NCT00003846|"~     RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral~     stem cell transplantation may allow doctors to give higher doses of radiation therapy and~     chemotherapy and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy, chemotherapy and~     peripheral stem cell transplantation in treating patients with primitive neuroectodermal~     tumors.~   "
265247|NCT00003752|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase II trial to study the effectiveness of bexarotene in treating~     patients who have metastatic breast cancer.~   "
265248|NCT00003669|"~     RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy~     using arzoxifene hydrochloride may fight the endometrial cancer by blocking the use of~     estrogen by the tumor cells~      PURPOSE: This phase II trial is studying how well arzoxifene hydrochloride works in treating~     women with recurrent, advanced, or metastatic endometrial cancer.~   "
265249|NCT00003580|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy~     and radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of amifostine in treating side effects of~     treatment in patients receiving radiation therapy and cisplatin for advanced head and neck~     cancer.~   "
265250|NCT00083395|"~     This study will examine the usefulness of a new test called an isoproterenol challenge in~     patients with arrhythmogenic right ventricular cardiomyopathy (ARVC) and family members who~     may have the disease but do not have clear-cut evidence of it. ARVC is a rare condition that~     runs in families. Heart muscle is replaced with fatty, scar-like tissue, especially in the~     right ventricle (lower pumping chamber of the heart), and can sometimes extend to the left~     ventricle (the main pumping chamber). The fat can interfere with the heartbeat, producing~     abnormal heart rhythms, such as ventricular tachycardia (VT) - a very fast heartbeat that can~     cause sudden death, especially in young people. Isoproterenol is a drug that increases heart~     rate and heart muscle contractions. In isoproterenol challenge, subjects are given increasing~     doses of the drug through a catheter (see details below) to try to produce an abnormal heart~     rhythm.~      ARVC is hard to diagnose with current tests. This study will see if isoproterenol challenge~     provokes VT in patients with the disease and can confirm the diagnosis; if it can detect the~     disease in family members better than currently available tests; and if it provokes abnormal~     rhythms in healthy control subjects. In addition, the study will explore the genetics of ARVC~     and determine whether infection could contribute to its development.~      Patients with ARVC, their family members, and normal volunteers 18 years of age and older may~     be eligible for this study. Candidates are screened with a medical history and physical~     examination, electrocardiogram (EKG), treadmill and bicycle exercise testing, and an~     echocardiogram (ultrasound test of the heart).~      Participants undergo the following tests and procedures:~        -  Blood tests - Blood is collected to study the genetics of ARVC, to test for evidence of~          old infections, and to measure brain natriuretic peptide - a hormone that can increase~          with development of heart failure.~        -  Heart magnetic resonance imaging (MRI). This test looks at heart structure and function.~          MRI uses a magnetic field and radio waves to produce images of body tissues and organs.~          The subject lies on a table that is moved into the scanner (a narrow cylinder), wearing~          earplugs to muffle loud knocking sounds that occur during the scanning process. At some~          time during the test, the subject is given a contrast agent called gadolinium through a~          catheter (thin, flexible tube) in a vein to improve the scan pictures. The scan time~          varies from 30 to 90 minutes, with most scans lasting 60 minutes. (Control subjects do~          not undergo MRI.)~        -  Isoproterenol challenge. Subjects are given increasing doses of isoproterenol through a~          catheter until the heart rate reaches 100 to 120 beats per minute for no more than 1~          hour. A special EKG records heart rhythm during the test and an echocardiogram records~          right and left ventricular function.~        -  QRST surface mapping EKG. This special EKG, done with 64 or 120 leads, maps~          abnormalities of heart rhythm and cardiac conduction during the isoproterenol challenge.~          These tests are like a regular EKG, except that more leads are placed on the chest, and~          on the back as well.~      Patients and family members who wish to have follow-up visits may return to the NIH Clinical~     Center once a year for 5 years for guidance about therapy based on clinical considerations~     and new information or investigations.~   "
265251|NCT00083382|"~     The purpose of this research is to study how helpful the combination of thalidomide and~     Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any~     side effects.~   "
265252|NCT00083369|"~     To characterize the genetic basis of the variable response of triglycerides to two~     environmental contexts, one that raises triglycerides (dietary fat), and one that lowers~     triglycerides (fenofibrate treatment.)~   "
265253|NCT00083343|"~     Candida is the most common fungal pathogen identified in hospitalized patients. This study~     will seek to enroll adult patients (18 years of age or older) with invasive Candida~     infections (involving deep tissues and organs). The study will not enroll patients whose only~     site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria~     will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin~     antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage~     strength and duration of caspofungin will be individualized for each patient based on~     disease, severity of disease and extent of infection.~   "
265254|NCT00008229|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radioactive drugs such as holmium Ho 166 DOTMP can kill cancer~     cells without harming healthy cells. Peripheral stem cell transplantation may be able to~     replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill~     tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan with or without~     holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients~     who have multiple myeloma.~   "
265255|NCT00008073|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Octreotide may help doxorubicin kill more cancer cells by making~     tumor cells more sensitive to the drug.~      PURPOSE: Phase I trial to study the effectiveness of octreotide and doxorubicin in treating~     patients who have advanced cancer.~   "
265256|NCT00006344|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known which regimen of radiation therapy may be more effective in preventing brain~     metastases.~      PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in~     preventing brain metastases in patients who have small cell lung cancer that has been~     diagnosed within the past year.~   "
265257|NCT00006269|"~     RATIONALE: Octreotide may be effective in preventing diarrhea that is caused by treatment~     with irinotecan.~      PURPOSE: Randomized phase III trial to study the effectiveness of octreotide in preventing~     diarrhea in patients who are receiving irinotecan for metastatic colon cancer.~   "
265258|NCT00003614|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus estramustine in~     treating patients who have metastatic prostate cancer that has not responded to hormone~     therapy.~   "
265259|NCT00003523|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients~     with recurrent or refractory ovarian epithelial cancer or primary cancer of the peritoneum.~   "
265260|NCT00003518|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus gemcitabine in treating~     patients with refractory metastatic germ cell tumors that have not responded to surgery or~     chemotherapy.~   "
265261|NCT00003444|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon~     alfa-2b may interfere with the growth of cancer cells. It is not yet known whether giving~     radiation therapy with interferon alfa-2b is more effective than giving interferon alfa-2b~     alone in treating melanoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus~     interferon alfa-2b with that of interferon alfa-2b alone in treating patients who have~     melanoma that has metastasized to lymph nodes in the neck, under the arm, or in the groin.~   "
272220|NCT00002127|"~     To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of~     thalidomide in reducing weight loss in patients with HIV wasting syndrome.~   "
265262|NCT00003405|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Biological therapies use different ways to stimulate the immune~     system and stop cancer cell from growing. Combining more than one chemotherapy drug with~     biological therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, isotretinoin,~     and interferon alfa in treating patients who have acute myelogenous leukemia.~   "
265263|NCT00003403|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of GPX-100 in treating patients who have~     solid tumors.~   "
265264|NCT00003269|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells~     from the side effects of chemotherapy.~      PURPOSE: Randomized phase II trial to study the effectiveness of amifostine followed by~     high-dose chemotherapy in treating patients with hematologic cancer or solid tumors.~   "
265265|NCT00003195|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Interferon alfa may interfere with the growth of cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, busulfan, and~     interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating~     patients with multiple myeloma.~   "
265266|NCT00003187|"~     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy used to kill cancer cells. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Eliminating the T cells from the donor cells before transplanting them may prevent this from~     happening.~      PURPOSE: Randomized phase II/III trial to compare the effectiveness of conventional bone~     marrow transplantation with T cell-depleted bone marrow transplantation in treating patients~     who have leukemia, myelodysplasia, or lymphoblastic lymphoma.~   "
265267|NCT00003098|"~     RATIONALE: The amount of dietary fat or fiber may affect estrogen metabolism in~     postmenopausal women, and this may affect the risk of developing cancer.~      PURPOSE: Randomized dietary intervention to study the effectiveness of a low-fat diet~     combined with either high fiber or low fiber on estrogen metabolism in healthy postmenopausal~     women.~   "
265268|NCT00003084|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy~     consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus~     doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.~   "
265269|NCT00003056|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the~     transplanted cells can make an immune response against the body's normal tissues.~      PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine plus~     methotrexate with cyclosporine plus T cell depletion for prevention of graft-versus-host~     disease during peripheral stem cell transplantation in patients who have advanced leukemia or~     lymphoma who are eligible for transplanted peripheral stem cells from a donor.~   "
265270|NCT00003004|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with paclitaxel~     and cisplatin plus flavopiridol in treating patients who have refractory or recurrent solid~     tumors.~   "
265271|NCT00002924|"~     RATIONALE: Gene mutations may make prostate cancer cells unable to attach to androgens. This~     may permit the growth of prostate cancer. Gene testing may improve the identification of~     patients with advanced prostate cancer.~      PURPOSE: Clinical trial to study the androgen receptor gene in patients with prostate cancer~     that is not responsive to hormone therapy.~   "
265272|NCT00002902|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating~     patients with advanced solid tumors.~   "
265273|NCT00002875|"~     RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet~     known which chemotherapy regimen is more effective when combined with radiation therapy for~     treating medulloblastoma.~      PURPOSE: Randomized phase III trial to compare two combination chemotherapy treatments plus~     radiation therapy in treating children with newly diagnosed medulloblastoma.~   "
265274|NCT00002780|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Combining different types of biological therapies may kill more~     tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of T cells and interleukin-2 combined~     with peripheral stem cell transplantation or bone marrow transplantation in treating women~     who have stage IIIB or metastatic breast cancer.~   "
265275|NCT00002750|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of melphalan in patients with persistent or~     recurrent neoplastic meningitis.~   "
265276|NCT00002734|"~     Phase I trial to study the effectiveness of radiolabeled monoclonal antibody, paclitaxel, and~     interferon alfa in treating patients who have ovarian cancer. Radiolabeled monoclonal~     antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to~     them without harming normal cells. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Interferon may interfere with the~     growth of cancer cells. Combining monoclonal antibody, chemotherapy, and interferon alfa may~     kill more tumor cells.~   "
265291|NCT00003908|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating~     patients who have metastatic or recurrent head and neck cancer.~   "
265277|NCT00002671|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients~     with recurrent or unresectable epithelial ovarian cancer that has been previously treated~     with platinum-based chemotherapy.~   "
265278|NCT00002664|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Colony-stimulating factors~     such as G-CSF may increase the number of immune cells found in bone marrow or peripheral~     blood, and may help a person's immune system kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus G-CSF~     in treating patients with metastatic colorectal cancer that has not responded to treatment~     with fluorouracil.~   "
265279|NCT00002576|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     consisting of cyclophosphamide, vincristine, and prednisolone, with either mitoxantrone or~     doxorubicin in treating patients with intermediate- or high-grade non-Hodgkin's lymphoma.~   "
265280|NCT00002571|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Antiviral therapy may be effective treatment for AIDS-related lymphoma.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation~     therapy, and antiviral therapy in treating patients who have AIDS-related lymphoma.~   "
265281|NCT00002567|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose radiation therapy and~     etoposide followed by peripheral stem cell transplantation in treating patients with acute~     leukemia.~   "
265282|NCT00002552|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining bone marrow transplantation with chemotherapy may allow~     doctors to give higher doses of chemotherapy and kill more tumor cells.~      PURPOSE: This phase II trial is studying the side effects of giving a bone marrow transplant~     together with chemotherapy and to see how well it works in treating patients with refractory~     non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.~   "
265283|NCT00002547|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may~     allow the doctor to give higher doses of chemotherapy and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation following~     combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic~     syndrome .~   "
265284|NCT00083356|"~     This study will examine whether bradykinin receptors are produced at the site of wisdom tooth~     extraction and if they contribute to the amount of inflammation and pain that follows~     surgery. Bradykinin is a molecule produced by enzymes at the site of an injury and then binds~     to receptors to cause pain. The study will also evaluate the role of genetic factors in the~     production of bradykinin and their receptors and the pain associated with minor surgical~     procedures.~      Patients between 16 and 35 years of age who are referred to the NIH dental clinic for removal~     of two wisdom teeth may be eligible for this study. Candidates must be in good health and~     must not be allergic to aspirin, non-steroidal anti-inflammatory drugs, sulfites, or amide~     anesthetics. They will be screened with a medical history and oral examination, including~     x-rays to confirm the need for wisdom tooth extraction.~      On the morning of surgery following an overnight fast, participants have a blood sample drawn~     to extract DNA for gene studies. Just before surgery, they are given an intravenous (IV)~     sedative to induce drowsiness and a local anesthetic to numb the mouth. They are also given~     IV either Ketorolac, a non-steroidal anti-inflammatory drug, or placebo, a look-alike~     medication with no active ingredient. After the extractions, a small piece of plastic tubing~     is placed in both extraction sites, and every 20 minutes for the next 3 hours inflammatory~     fluid is collected from the tubing for measuring chemicals believed to cause pain and~     swelling. Patients rate their pain by answering pain-related questions every 20 minutes.~     Patients who have pain that is not relieved by the study medication (Ketorolac or placebo)~     are given, upon request, 50 mg of the pain reliever tramadol (Ultram). Patients remain in the~     clinic for at least 3 hours and no more than 7 hours after surgery in order for monitoring~     the effects of the study drugs as the local anesthetic wears off.~      Patients undergo two biopsies during the study - one before and one after the extraction - to~     measure any changes in chemicals produced in response to the surgery. The second biopsy is~     done either 3, 7, or 24 hours after the extraction. Patients in the 3- and 7-hour groups are~     given a small dose of local anesthetic in the gum for the second biopsy and remain in the~     clinic until the biopsy is done; those in the 24-hour group are given forms to record pain~     ratings at home and return to the clinic the following morning for a 2-hour follow-up visit.~     All patients are given standard pain medication (flurbiprofen) to take at home.~   "
265285|NCT00005648|"~     The purpose of this study is to compare the effectiveness of gemcitabine with or without~     tipifarnib (R115777) in patients who have advanced pancreatic cancer.~   "
265286|NCT00004198|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Vaccines may make the body build an immune response to kill tumor~     cells. Sargramostim may stimulate a person's immune system and help to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus sargramostim~     following chemotherapy in treating patients who have stage III or stage IV non-Hodgkin's~     lymphoma.~   "
265287|NCT00004126|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and oxaliplatin in~     treating patients who have recurrent or advanced non-small cell lung cancer.~   "
265288|NCT00004122|"~     RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system~     and stop cancer cells from growing. Interferon alfa may interfere with the growth of cancer~     cells. Combining these therapies may be an effective treatment for bladder cancer.~      PURPOSE: Phase II trial to study the effectiveness of BCG plus interferon alfa 2b in treating~     patients who have bladder cancer.~   "
265289|NCT00004113|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have recurrent malignant glioma.~   "
265290|NCT00003976|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have~     solid tumors.~   "
273725|NCT00005550|"~     To evaluate airway inflammation in persons with asthma exposed to endotoxin, a common~     occupational air contaminant. Subjects are subsequently challenged with allergen.~   "
265292|NCT00003822|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have~     advanced solid tumors.~   "
265293|NCT00003747|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and temozolomide~     in treating patients who have unresectable or metastatic melanoma.~   "
265294|NCT00003724|"~     RATIONALE: Video-assisted surgery may have fewer side effects than conventional surgery in~     patients with lung metastases. It is not yet known whether conventional surgery or~     video-assisted surgery is more effective in treating lung metastases.~      PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with~     that of video-assisted surgery in treating patients who have lung metastases.~   "
265295|NCT00003670|"~     RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using~     arzoxifene hydrochloride may fight ovarian or peritoneal cancer by blocking the use of~     estrogen by the tumor cells.~      PURPOSE: This phase II trial is studying how well arzoxifene hydrochloride works in treating~     women with metastatic refractory ovarian cancer or primary peritoneal cancer.~   "
265296|NCT00003606|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether combination chemotherapy with or without epirubicin and cyclophosphamide is~     more effective in treating patients with extensive stage small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without epirubicin and cyclophosphamide in treating patients who have extensive stage~     small cell lung cancer.~   "
265297|NCT00003562|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in~     treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
265298|NCT00003490|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. GM-CSF may make cancer cells more sensitive to the effects of~     chemotherapy. Combining more than one drug with GM-CSF may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of~     cyclophosphamide plus vincristine, following GM-CSF in treating patients with multiple~     myeloma that has not responded to previous treatment.~   "
265299|NCT00003447|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine, gemcitabine,~     or both in treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
265300|NCT00003365|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of sulindac may be an effective way to prevent~     colon cancer. Eating a diet rich in fruits and vegetables appears to reduce the risk of some~     types of cancer. Curcumin, rutin, and quercetin are compounds found in plants that may~     prevent the development of colon cancer.~      PURPOSE: Randomized clinical trial to study the effectiveness of sulindac, curcumin, rutin,~     and quercetin in preventing colon cancer.~   "
265301|NCT00003322|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving drugs in different ways may~     kill more tumor cells. It is not yet known whether intravenous two-drug combination~     chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug~     combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug~     combination chemotherapy with intravenous and intraperitoneal three-drug combination~     chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian~     cancer.~   "
265302|NCT00003289|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of UCN-01 in treating patients with~     advanced cancer that has not responded to previous treatment.~   "
265303|NCT00003250|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating patients who~     have solid tumors.~   "
265304|NCT00003101|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and combining chemotherapy with~     autologous bone marrow transplantation or peripheral stem cell transplantation may allow~     doctors to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bone~     marrow transplantation or peripheral stem cell transplantation in treating patients who have~     oligodendroglioma.~   "
265305|NCT00002880|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients with~     relapsed non-Hodgkin's lymphoma.~   "
265306|NCT00002876|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with recurrent ependymomas following radiation therapy.~   "
265307|NCT00002813|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin~     and vinorelbine in treating patients with refractory or recurrent squamous cell cervical~     cancer that has not responded to local therapy.~   "
265308|NCT00002787|"~     The purpose of this trial is to test the safety and immune response to four immunizations~     with this vaccine made from a protein produced by the patient's tumor. There is no guarantee~     or promise that this procedure will be successful~   "
265309|NCT00002707|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if chemotherapy given before surgery is more~     effective with or without docetaxel given before or after surgery for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using~     doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage~     II or stage III breast cancer.~   "
265310|NCT00002692|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous infusion or~     intrahepatic infusion of fluorouracil and leucovorin in treating patients with colorectal~     cancer metastatic to the liver.~   "
265311|NCT00002673|"~     RATIONALE: White blood cells from donors who have been exposed to cytomegalovirus may be able~     to help prevent this infection from occurring in patients who are undergoing bone marrow or~     peripheral stem cell transplantation.~      PURPOSE: Phase II trial to study the effectiveness of donated white blood cells to prevent~     cytomegalovirus infection in patients who are undergoing bone marrow or peripheral stem cell~     transplantation.~   "
265312|NCT00002599|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with~     chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more~     cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet~     known whether a more intensive chemotherapy regimen plus stem cell or bone marrow transplant~     is more effective than standard chemotherapy in treating patients with myeloma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of~     combination chemotherapy plus interferon alfa with or without high dose melphalan or bone~     marrow or peripheral stem cell transplantation in treating patients with previously untreated~     myeloma.~   "
265313|NCT00083330|"~     This study will test the safety of an experimental vaccine against HIV infection and see if~     it causes an immune response to HIV. The vaccine is given by injection (shot) in the upper~     arm. It is made from DNA that codes for three HIV proteins. The DNA is inserted into an~     adenovirus that carries it into the muscle cells. The adenovirus normally can cause eye or~     upper respiratory infections, such as a cold; however, for the vaccine, it has been modified~     so that it cannot cause illness. Nor can the vaccine cause HIV infection, because it codes~     for only three of the nine HIV proteins.~      Healthy, normal volunteers between 18 and 44 years of age who are not HIV-infected may be~     eligible for this study. Candidates are screened with a medical history and physical~     examination and blood and urine tests.~      Participants are randomly assigned to receive either the experimental vaccine or a placebo~     (an inactive substance that looks like the vaccine). The vaccine or placebo is administered~     to participants in groups, according to their entry into the study. The first group receives~     the lowest study dose of vaccine. If this dose is safe, then the second group receives a~     higher dose. If this dose is also safe, then the third and final group receives the highest~     study dose. Clinic staff observe the subjects for side effects for 30 minutes after the~     injection, and subjects keep a diary card for the next 5 days, recording their temperature~     and any symptoms that may appear. Subjects are contacted by a nurse 2 days after the~     injection for follow-up.~      Participants are seen at the clinic for follow-up visits 1, 2, 4, 12, and 24 weeks after the~     injection, and then are contacted by telephone for follow-up once a year until 5 years after~     the injection. The clinic visits include a physical examination, medical history, blood and~     urine tests, and HIV counseling, as needed. Women have pregnancy tests at the screening~     evaluation and again at study week 24. All subjects are tested for HIV at screening and at~     study weeks 12 and 24, and all subjects complete a social impact questionnaire at week 24.~     All subjects are asked questions about their sexual behavior and drug use.~   "
265314|NCT00083278|"~     This Phase II study is designed to treat patients who have been diagnosed with Stage IV~     Breast Cancer, which has progressed despite treatment with primary therapies, including~     hormonal therapy, chemotherapy, and antibody therapy. Thirty-three patients will be treated~     with the monoclonal antibody MDX-010. The initial antitumor activity profile of MDX-010 will~     be determined, as well as identification of the induction of any antitumor immunity following~     the MDX-010 treatment.~   "
265315|NCT00012350|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have~     relapsed or refractory multiple myeloma.~   "
265316|NCT00010088|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and~     fluorouracil in treating patients who have locally advanced or metastatic cancer of the~     pancreas or bile duct.~   "
265317|NCT00006220|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal~     white blood cells.~      PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide with or without~     tretinoin in treating patients who have hematologic cancer that has not responded to previous~     therapy.~   "
265318|NCT00005814|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy~     with monoclonal antibody therapy and radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cetuximab, cisplatin, and~     radiation therapy in treating patients who have advanced stage III or stage IV head and neck~     cancer.~   "
265319|NCT00005581|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of chemotherapy is more effective for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of~     combination chemotherapy in treating women who have stage II or stage III breast cancer.~   "
265320|NCT00004880|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have advanced kidney cancer.~   "
265321|NCT00004211|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     who have metastatic prostate cancer.~   "
265322|NCT00004156|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~   "
273726|NCT00005549|"~     To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven~     T-cell mediated, airway inflammation.~   "
265323|NCT00004132|"~     RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving~     radiation therapy and chemotherapy.~      PURPOSE: Randomized phase II trial to study the effectiveness of keratinocyte growth factor~     in preventing oral mucositis in patients who have hematologic cancers and who are undergoing~     radiation therapy and chemotherapy before autologous peripheral stem cell transplantation.~   "
265324|NCT00004073|"~     RATIONALE: Suramin may stop the growth of glioblastoma multiforme by stopping blood flow to~     the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining suramin~     with radiation therapy may be a more effective treatment for glioblastoma multiforme.~      PURPOSE: Phase II trial to study the effectiveness of suramin plus radiation therapy in~     treating patients who have newly diagnosed glioblastoma multiforme.~   "
265325|NCT00004056|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give~     higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by~     melphalan and peripheral stem cell transplantation in treating children who have newly~     diagnosed acute myeloid leukemia that has not been treated previously.~   "
265326|NCT00004051|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients who have~     advanced solid tumors.~   "
265327|NCT00004038|"~     Phase I trial to study the effectiveness of gene therapy plus chemotherapy in treating~     patients who have breast cancer. Inserting the p53 gene into a person's cancer cells may~     improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.~     Combining chemotherapy with gene therapy may kill more tumor cells.~   "
265328|NCT00003924|"~     RATIONALE: Interferon-alfa may interfere with the growth of cancer cells. Giving~     interferon-alfa following chemotherapy and peripheral stem cell transplantation may be an~     effective treatment for Hodgkin's disease or non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa-2b~     following chemotherapy and stem cell transplantation in treating patients who have recurrent~     or refractory Hodgkin's disease or non-Hodgkin's lymphoma.~   "
265329|NCT00003876|"~     RATIONALE: Internal radiation uses high-energy radiation to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining internal radiation therapy with chemotherapy implants may kill remaining tumor~     cells following surgery.~      PURPOSE: Phase I trial to study the effectiveness of internal radiation therapy plus~     carmustine implants in treating patients who have recurrent or refractory malignant glioma.~   "
265330|NCT00003801|"~     RATIONALE: Cancer treatment may have risks that affect health outcomes later. It is not yet~     known what health outcomes may be related to previous treatment for rhabdomyosarcoma.~      PURPOSE: Study to determine health outcomes in patients who have survived 5 years after~     receiving treatment for rhabdomyosarcoma on the Intergroup Rhabdomyosarcoma Study Group~     protocols.~   "
265331|NCT00003731|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with~     recurrent oligodendroglial tumors.~   "
265332|NCT00003700|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have untreated acute lymphoblastic leukemia.~   "
265333|NCT00003698|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating~     patients who have advanced malignant solid tumors.~   "
265334|NCT00003697|"~     RATIONALE: Dimethylxanthenone acetic acid may stop the growth of cancer cells by stopping~     blood flow to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of dimethylxanthenone acetic acid in~     treating patients with solid tumors that have not responded to previous therapy.~   "
265335|NCT00003685|"~     RATIONALE: Radiation therapy may relieve symptoms in patients with non-small cell lung~     cancer. It is not yet known which regimen of radiation therapy is most effective in relieving~     symptoms in patients with non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     radiation therapy to relieve symptoms in patients who have non-small cell lung cancer.~   "
265336|NCT00003640|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combination chemotherapy combined with transurethral resection may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of transurethral resection plus~     combination chemotherapy in treating patients who have stage II or stage III bladder cancer.~   "
265337|NCT00003575|"~     Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in~     treating patients who have refractory HIV-associated non-Hodgkin's lymphoma. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by~     stimulating a person' white blood cells to kill cancer cells.~   "
265338|NCT00003439|"~     Phase I trial to study the effectiveness of interleukin-12 in treating patients with~     refractory ovarian or abdominal cancers. Interleukin-12 may kill tumor cells by stopping~     blood flow to the tumor and by stimulating a persons's white blood cells to kill cancer~     cells.~   "
265339|NCT00003423|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's~     lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     combination chemotherapy in treating children who have newly diagnosed non-Hodgkin's~     lymphoma.~   "
265340|NCT00003330|"~     Phase I trial to study the effectiveness of interleukin-12 in treating patients who have~     advanced cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and~     by stimulating a person's white blood cells to kill cancer cells.~   "
265341|NCT00003326|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with~     metastatic, recurrent, or unresectable cancer of the esophagus.~   "
265342|NCT00003255|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining carboplatin and topotecan in~     treating patients with relapsed acute myelogenous leukemia.~   "
265343|NCT00002578|"~     RATIONALE: Chemotherapy uses different ways to stop cancer cells from dividing so they stop~     growing or die.~      PURPOSE: Phase II trial to study the effectiveness of gallium nitrate in treating patients~     with AIDS-related non-Hodgkin's lymphoma.~   "
265344|NCT00002503|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. This may be an~     effective treatment for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of strontium or radiation~     therapy in treating patients with prostate cancer that is refractory to hormone therapy who~     have painful bone metastases.~   "
265345|NCT00083317|"~     This study will identify which areas of the brain mediate the interaction between people~     involved in economic decision-making.~      Healthy, right-handed native English speakers between 21 and 55 years of age may be eligible~     for this study. Candidates are screened with a telephone interview, a questionnaire to~     determine handedness, and a neurological examination if one has not been performed within the~     last year by an NIH physician.~      Participants bargain for money by playing two-person trust games, while undergoing functional~     magnetic resonance imaging (fMRI). MRI uses a strong magnetic field and radio waves to obtain~     images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong~     magnetic field. During the procedure, the subject lies on a stable that can slide in and out~     of the scanner, wearing earplugs to muffle loud knocking sounds that occur with electrical~     switching of the magnetic fields. Functional MRI involves taking MRI scans while the subject~     performs a task-this to learn about how the brain regions are involved in performing the~     task. For this test, the subject plays or watches two-person games involving trust. The game~     may be played against a stranger or a friend. The winner receives a cash payoff.~      The subject performs one of the following two tasks during MRI scanning:~        -  Playing the trust games and indicating as quickly as possible by pressing a right or~          left button whether he or she wants to stop or continue playing, or~        -  Observing games that others have played and predicting as quickly as possible by~          pressing a right or left button whether the players wanted to stop or continue the~          games.~      The test takes about 90 minutes. After the scan, participants complete written questionnaires~     about their experience in the scanner and their views on issues related to participating in~     competitive games.~   "
265346|NCT00083304|"~     RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3,~     randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer~     patients with brain metastases in that trial, 59 patients who received RSR13 prior to~     radiation therapy had a median survival time that was twice as long as the 52 patients who~     did not receive RSR13 prior to radiation therapy.~      RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from~     blood into the tissues. It is well known that certain types of cancer tumors, including those~     in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of~     radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation~     therapy works better.~      This study will enroll up to 360 women with brain metastases from breast cancer, and will~     evaluate if whole brain radiation therapy given with RSR13 will have a better treatment~     effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV)~     through a central catheter placed in a central vein. Women randomized (assigned) to receive~     RSR13, therefore, will need to have a central catheter placed for treatment unless one is~     already in place.~   "
265347|NCT00083213|"~     RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by~     stopping blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of intravenous VEGF~     Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's~     lymphoma.~   "
265348|NCT00082940|"~     RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth~     of cancer cells and slow the growth of chronic lymphocytic leukemia.~      PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating~     patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.~   "
265349|NCT00082927|"~     RATIONALE: Ibandronate may be effective in reducing bone pain caused by metastatic cancer.~     Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether~     ibandronate is more effective than standard treatment with radiation therapy in treating~     metastatic bone pain.~      PURPOSE: This phase III randomized clinical trial is studying ibandronate to see how well it~     works compared to single-dose local radiation therapy in treating patients with localized~     metastatic bone pain.~   "
265350|NCT00082914|"~     RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill~     tumor cells.~      PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating~     patients with metastatic melanoma or metastatic kidney cancer.~   "
265351|NCT00082888|"~     This phase II trial studies how well tipifarnib works in treating patients with relapsed or~     refractory non-Hodgkin's lymphoma. Tipifarnib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Tipifarnib may be an effective treatment for~     non-Hodgkin's lymphoma.~   "
265352|NCT00082875|"~     This randomized phase II trial is studying how well cilengitide works in treating patients~     with unresectable stage III or stage IV melanoma. Cilengitide may stop the growth of melanoma~     by stopping blood flow to the tumor.~   "
265353|NCT00082862|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Giving low-dose~     interferon alfa on a metronomic (regularly timed) schedule may stop the growth of cancer by~     stopping blood flow to the tumor. Fever-range (above 101° F) whole-body hyperthermia kills~     tumor cells by heating them to several degrees above normal body temperature. Combining~     cisplatin, gemcitabine, and low-dose interferon alfa with fever-range whole-body hyperthermia~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cisplatin, gemcitabine, and~     metronomic low-dose interferon alfa together with fever-range whole-body hyperthermia works~     in treating patients with inoperable or metastatic pancreatic cancer.~   "
265575|NCT00002964|"~     RATIONALE: Drugs that make cancer cells more visible to light may help in the diagnosis of~     head and neck cancer.~      PURPOSE: Phase II trial to study the usefulness of porfimer sodium in diagnosing patients~     with head and neck cancer.~   "
265354|NCT00082836|"~     RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan,~     can locate cancer cells and either kill them or deliver radioactive cancer-killing substances~     to them without harming normal cells.~      PURPOSE: This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan~     together with rituximab works in treating patients with recurrent primary CNS lymphoma.~   "
265355|NCT00082823|"~     RATIONALE: Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's~     lymphoma by stopping blood flow to the cancer.~      PURPOSE: This phase I trial is studying the side effects of VEGF Trap in treating patients~     with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.~   "
265356|NCT00082810|"~     This phase II trial is studying how well giving tipifarnib together with fulvestrant works as~     second-line therapy in treating postmenopausal women with hormone receptor-positive~     inoperable locally advanced or metastatic breast cancer that has progressed after previous~     first-line endocrine therapy. Tipifarnib may stop the growth of tumor cells by blocking the~     enzymes necessary for their growth. Estrogen can stimulate the growth of breast cancer cells.~     Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen.~     Combining tipifarnib with fulvestrant may kill tumor cells that did not respond to first-line~     therapy.~   "
265357|NCT00082797|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Leucovorin may decrease side effects~     caused by high-dose methotrexate.~      PURPOSE: This phase II trial is studying how well giving high-dose methotrexate together with~     leucovorin works in treating patients with newly diagnosed glioblastoma multiforme.~   "
265358|NCT00082784|"~     Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their~     growth. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop~     cancer cells from dividing so they stop growing or die. Bortezomib may increase the~     effectiveness of flavopiridol by making cancer cells more sensitive to the drug. Giving~     bortezomib together with flavopiridol may kill more cancer cells. This phase I trial is~     studying the side effects and best dose of bortezomib and flavopiridol in treating patients~     with recurrent or refractory indolent B-cell neoplasms.~   "
265359|NCT00082758|"~     RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in~     different ways to stimulate the immune system and stop tumor cells from growing.~      PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works~     in treating young patients with recurrent or refractory neuroblastoma.~   "
265360|NCT00082745|"~     This clinical trial studies cancer survivors to identify those who are at increased risk of~     developing late-occurring complications after undergoing treatment for childhood cancer. A~     patient's genes may affect the risk of developing complications, such as congestive heart~     failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment.~     Genetic studies may help doctors identify survivors of childhood cancer who are more likely~     to develop late complications.~   "
265361|NCT00082732|"~     RATIONALE: A low-fat, high-fiber diet that includes soy protein may prevent disease~     progression in patients with hormone-refractory prostate cancer. Nutrition counseling may~     help motivate patients to follow this diet.~      PURPOSE: Randomized phase I trial to study the effectiveness of behavior-based dietary~     interventions, such as receiving nutrition counseling, in helping patients who have~     hormone-refractory prostate cancer follow a low-fat, high-fiber, soy-supplemented diet.~   "
265362|NCT00082719|"~     RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth~     of urothelial cancer.~      PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa works in~     treating patients with cancer of the urothelium.~   "
265363|NCT00082706|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, gemcitabine, and~     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving fluorouracil together with~     leucovorin, gemcitabine, and cisplatin works in treating patients with metastatic or~     unresectable adenocarcinoma of the urothelium or urachal remnant (part of the bladder).~   "
265364|NCT00082667|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. It is not yet known whether surgery is more effective with or without gefitinib~     in treating ductal carcinoma in situ.~      PURPOSE: This randomized phase II trial is studying how well gefitinib together with surgery~     works compared to surgery alone for the treatment of women with ductal carcinoma in situ of~     the breast.~   "
265365|NCT00082654|"~     RATIONALE: Understanding the emotional needs of spouses or others who are living with and~     caring for patients who have undergone stem cell transplantation may help improve the quality~     of life of both the caregivers and the patients.~      PURPOSE: This clinical trial is studying the emotional needs of caregivers of patients who~     have undergone stem cell transplant.~   "
265366|NCT00082641|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs~     used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy before and/or~     after chemotherapy and radiation therapy may cause a stronger immune response.~      PURPOSE: This randomized phase I/II trial is studying the side effects of two regimens of~     vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant~     or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that~     overexpresses p53.~   "
265367|NCT00003186|"~     RATIONALE: Diagnostic procedures, such as lymphography, may improve the identification of~     patients with metastatic colorectal cancer.~      PURPOSE: Clinical trial to study the effectiveness of lymphography in determining the~     presence or absence of metastatic colorectal cancer in patients.~   "
265368|NCT00003183|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with G-CSF may make tumor cells more~     sensitive to the chemotherapy drug and may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of mitoxantrone plus G-CSF in treating~     patients with metastatic prostate cancer that has not responded to hormone therapy.~   "
273942|NCT00005330|"~     To identify early childhood determinants of eating and exercise behaviors that relate to~     cardiovascular disease.~   "
265369|NCT00003154|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients~     with stage III or stage IV non-small cell lung cancer.~   "
265370|NCT00003118|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not yet known whether surgery is more effective with or without chemotherapy and radiation~     therapy for cancer of the esophagus.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without~     combination chemotherapy and radiation therapy in treating patients who have cancer of the~     esophagus that can be surgically removed.~   "
265371|NCT00003117|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or~     without carboplatin in treating patients who have recurrent, stage IIIB, or stage IV~     non-small cell lung cancer.~   "
265372|NCT00003095|"~     RATIONALE: Drugs used in chemotherapy for breast cancer may damage the genes of cells. This~     may lead to the development of secondary cancers.~      PURPOSE: Pilot study to evaluate the degree of gene damage following chemotherapy in women~     with stage II or stage III breast cancer involving four to nine axillary lymph nodes.~   "
265373|NCT00003020|"~     RATIONALE: LMB-7 immunotoxin can locate tumor cells and kill them without harming normal~     cells.~      PURPOSE: Phase I trial to study the effectiveness of LMB-7 immunotoxin in treating patients~     who have leptomeningeal metastases metastases.~   "
265374|NCT00002988|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus carmustine in treating~     patients who have recurrent primary malignant glioma.~   "
265375|NCT00002985|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether doxorubicin is more effective than~     daunorubicin for AIDS-related Kaposi's sarcoma.~      PURPOSE: Randomized double-blinded phase III trial to determine if doxorubicin is more~     effective than daunorubicin in treating patients who have AIDS-related Kaposi's sarcoma.~   "
265376|NCT00002961|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy,~     radiation therapy, and bone marrow transplantation may kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare high-dose chemotherapy with or without~     total-body irradiation before bone marrow transplantation in treating children with acute~     lymphoblastic leukemia.~   "
265377|NCT00083291|"~     This study will examine whether infection with Helicobacter pylori bacteria may cause~     inflammation of the eye's surface. Although most people who are infected with H. pylori do~     not have symptoms, the bacteria can cause several diseases, including gastritis-stomach~     inflammation, stomach ulcers or, rarely, stomach cancer, and certain types of lymphoma. H.~     pylori has also been associated with autoimmune disorders, in which the patient's immune~     system attacks the body's own tissues.~      People who have been infected with H. pylori, with and without dry eye, may be eligible for~     this study. Candidates are screened with a medical history, a blood test to determine H.~     pylori infection, and an eye examination. The examination includes measurements of visual~     acuity, eye pressure, and tear production. To measure the amount of tear production, a small~     piece of filter paper is inserted over the eyelid on the side and collects tears over a~     5-minute period. Drops of two colored dyes (orange and green) are placed in the eyes to see~     if there are any dry areas. Screening also includes examination of the pupils and eye~     movements, the lens, and the back of the eye, including the retina.~      Participants will also have a few cells collected from the surface of the eye. After the eyes~     are numbed with anesthetic eye drops, a swab (like a Q-tip) is rolled over the surface of the~     white part of the eye to collect small samples of the superficial layer of the conjunctiva -~     a transparent membrane covering the eyeball. The specimens are analyzed by special laboratory~     techniques to determine whether H. pylori has infected the eye.~   "
265378|NCT00083252|"~     The purpose of this study is to assess the antitumor activity and safety of the combination~     of talabostat and cisplatin in patients with metastatic melanoma.~   "
265379|NCT00083239|"~     The purpose of this study is to assess the antitumor activity and safety of talabostat in~     patients with metastatic melanoma.~   "
265380|NCT00083265|"~     This study will try to identify genes that increase the risk of developing panic disorder-an~     anxiety disorder characterized by recurrent unexpected panic attacks-and that contribute to~     the abnormalities associated with it. It will compare reactions in patients with panic~     disorder and in normal volunteers to caffeine, a compound that can induce anxiety, and to~     placebo, an inactive substance. Caffeine is believed to induce anxiety by blocking proteins~     called adenosine receptors on the surface of nerve cells in the brain. One study found that~     people with a specific adenosine receptor gene called 1976T/T had greater anxiety in response~     to caffeine challenge than did people with other adenosine receptor gene groups. There is~     also evidence that people with the 1976T/T genotype are more vulnerable to having panic~     disorder.~      Normal volunteers and patients with panic disorder (with or without agoraphobia) who are~     between 18 and 60 years of age may be eligible for this study. Candidates are screened with~     physical and psychiatric examinations, a diagnostic interview, mood and anxiety ratings, an~     electrocardiogram, and blood and urine tests, including genetic studies.~      Participants have two caffeine/placebo challenge sessions at least 3 days apart. Each session~     lasts about 4 hours. For at least 1 week before each session, subjects follow a diet~     excluding foods with caffeine and refrain from drinking alcoholic beverages for at least 48~     hours before the procedure. The morning of the session, following an overnight fast, subjects~     swallow either a placebo capsule or a caffeine capsule that is equivalent to about 5 cups of~     coffee. During the session, subjects take a battery of neuropsychological tests to document~     changes in cognitive and emotional functioning, including attention, memory, and motor~     performance. In addition, heart rate and blood pressure are measured 15 minutes before and~     30, 60, 90, 120, 150, and 180 minutes after the caffeine or placebo dose.~      At the end of the study, patients with panic disorder are eligible to receive routine~     clinical treatment for up to 3 months and may participate in planning for long-term treatment~     under the care of their local health care provider.~   "
265381|NCT00083226|"~     This phase II trial is studying how well giving doxorubicin together with bortezomib works in~     treating patients with liver cancer. Drugs used in chemotherapy, such as doxorubicin, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may~     stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving~     doxorubicin together with bortezomib may kill more tumor cells.~   "
265382|NCT00083187|"~     RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different~     ways to stop cancer cells from dividing so they stop growing or die. Hydroxyurea may help~     VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug.~      PURPOSE: This phase II trial is studying how well giving VNP40101M with hydroxyurea works in~     treating patients with acute myelogenous leukemia or high-risk myelodysplasia.~   "
265383|NCT00083174|"~     RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may~     prevent breast cancer by blocking the production of estrogen.~      PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is~     to allow all study participants the opportunity to complete 5 years of exemestane.~   "
265384|NCT00083161|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide,~     work in different ways to stop tumor cells from dividing so they stop growing or die.~     Combining more than one chemotherapy drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and~     cyclophosphamide together works in treating patients with extensive-stage small cell lung~     cancer.~   "
265385|NCT00083148|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help~     capecitabine kill more tumor cells by making tumor cells more sensitive to the drug.~      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and~     capecitabine in treating women with advanced breast cancer.~   "
265386|NCT00083135|"~     RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (^131I-MIBG) may kill neuroblastoma~     cells by delivering radiation directly to the tumor. A stem cell transplant using the~     patient's stem cells may be able to replace blood-forming cells destroyed by radiation~     therapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion~     of ^131I-MIBG followed by autologous stem cell transplantation in treating patients with~     refractory neuroblastoma.~   "
265387|NCT00083122|"~     This phase II trial is studying how well giving cisplatin together with flavopiridol works in~     treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer. Drugs~     used in chemotherapy, such as cisplatin and flavopiridol, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Combining more than one drug may kill~     more tumor cells.~   "
265388|NCT00083109|"~     Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells~     from dividing so they stop growing or die. Suramin may increase the effectiveness of~     fluorouracil by making tumor cells more sensitive to the drug. This phase I/II trial is~     studying the side effects and best dose of fluorouracil and the chemosensitizer suramin and~     to see how well they work in treating patients with metastatic renal cell (kidney) cancer.~   "
265389|NCT00083096|"~     RATIONALE: Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Giving lonafarnib together with~     temozolomide may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when~     given together with temozolomide in treating patients with recurrent primary supratentorial~     glioma.~   "
265390|NCT00083083|"~     RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography~     (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict~     a patient's response to treatment and plan more effective treatment.~      PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting~     disease progression and determining response to treatment in patients who are undergoing~     chemoradiotherapy for locally advanced non-small cell lung cancer.~   "
265391|NCT00083070|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     cancer cells from dividing so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide in~     treating young patients with refractory or recurrent leukemia.~   "
265392|NCT00083057|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy~     x-rays to damage tumor cells. Giving gefitinib and paclitaxel together with radiation therapy~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and~     paclitaxel when given together with radiation therapy in treating patients with advanced or~     recurrent squamous cell carcinoma (cancer) of the head and neck.~   "
265393|NCT00083044|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of or treat early cancer. Diagnostic procedures, such as ductal lavage, may~     improve the ability to assess the effectiveness of chemopreventive drugs, such as tamoxifen,~     on breast cells and may help doctors plan more effective treatment.~      PURPOSE: This phase II trial is studying how well ductal lavage works in assessing changes in~     breast cells in women with early breast cancer or in those at high risk of developing breast~     cancer who are eligible for tamoxifen therapy.~   "
265394|NCT00083031|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may~     stop the growth of breast cancer by stopping blood flow to the tumor. Giving metronomic~     (regularly timed) low-dose cyclophosphamide and methotrexate together with bevacizumab may~     kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying metronomic low-dose cyclophosphamide and~     methotrexate to see how well they work compared to metronomic low-dose cyclophosphamide,~     methotrexate, and bevacizumab in treating women with metastatic breast cancer.~   "
265395|NCT00083018|"~     RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct~     endoscopy, may help doctors detect and assess breast cancer cells early and plan more~     effective treatment.~      PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct~     endoscopy work in assessing cancer cells in women who are undergoing surgery for breast~     cancer.~   "
265529|NCT00002590|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     children who have lymphoma.~   "
265396|NCT00083005|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the~     growth of prostate cancer by stopping blood flow to the tumor. Giving chemotherapy together~     with thalidomide may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together~     with thalidomide works in treating patients with androgen-independent metastatic~     adenocarcinoma (cancer) of the prostate.~   "
265397|NCT00082979|"~     RATIONALE: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to~     detect breast cancer earlier and plan more effective treatment.~      PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing~     cellular atypia (abnormal cells) in the breast ducts of women with a genetic risk for breast~     cancer.~   "
265398|NCT00082966|"~     Phase II trial to study the effectiveness of bortezomib in treating patients who have~     relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by~     blocking the enzymes necessary for their growth.~   "
265399|NCT00082628|"~     The primary objective of the study is to determine if Serostim® 4 mg administered daily for~     12 weeks as treatment for the abnormal fat accumulation and distribution associated with~     HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT,~     measured by CT scan) more effectively than placebo.~   "
265400|NCT00082602|"~     The purpose of this study is to evaluate the safety and tolerability of an extended release~     formulation of the drug galantamine using a rapid dose escalation regimen.~   "
265401|NCT00082589|"~     The purpose of this study is to determine if eplerenone is effective in the treatment of mild~     to moderate heart failure~   "
265402|NCT00082576|"~     The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is~     non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P.~     falciparum.~   "
265403|NCT00082563|"~     The purpose of this study is to determine if Azithromycin in combination with chloroquine is~     superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in~     asymptomatic, semi-immune adults in Western Kenya.~   "
265404|NCT00082615|"~     This study will use a technique called blink reflex to study and compare how the brain~     controls muscle movement in patients with craniofacial dystonia, their first-degree~     relatives, and healthy, normal volunteers. People with dystonia have sustained muscle~     contractions that cause twisting and repetitive movements or abnormal postures. In focal~     dystonia, this happens in one area of the body, such as the hand, neck, or face.~      Three groups of people may be eligible for this study: 1) patients 18 years of age and older~     with craniofacial dystonia; 2) first-degree relatives of patients with craniofacial dystonia;~     and 3) normal volunteers matched in age to the patients. Candidates are screened with~     physical and neurological examinations.~      Participants undergo a blink reflex study. Patients with dystonia who are receiving botulinum~     toxin injections must stop the medication 3 months before participating in the study and must~     stop any other dystonia medications, such as benzodiazepines and anticholinergics, for 12~     hours before the study. For the blink reflex procedure, subjects are seated in a comfortable~     chair with their hands placed on a pillow on their lap. Metal electrodes are taped to the~     forehead for delivering small electrical shocks that feel like very brief pinpricks. Subjects~     receive 25 to 50 electrical stimuli, some as single shocks and some in pairs. The electrical~     activity of muscles that respond to the stimuli is recorded with a computer. The study takes~     from about 1 to 2 hours.~   "
265405|NCT00082537|"~     This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in~     the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute~     neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic~     coverage. Such patients would be candidates for empirical therapy with an intravenous~     anti-fungal agent.~   "
265406|NCT00082524|"~     This study is an open label, noncomparative study using an investigational agent for the~     treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3~     months-17 years).~   "
265407|NCT00002936|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of altretamine plus etoposide in treating~     patients with HIV-related cancer.~   "
265408|NCT00002903|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with~     recurrent or refractory germ cell cancer.~   "
265409|NCT00002896|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug, giving the drugs in different ways,~     and combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus~     fluorouracil and leucovorin before surgery given with or without fluorouracil and leucovorin~     after surgery in patients with locally advanced rectal cancer.~   "
265410|NCT00002893|"~     RATIONALE: Palliative chemotherapy may help patients with advanced colorectal cancer live~     longer and more comfortably.~      PURPOSE: Randomized phase III trial to compare the effectiveness of and quality of life~     following three different palliative chemotherapy regimens in treating patients with advanced~     metastatic or recurrent colorectal cancer.~   "
265411|NCT00002892|"~     RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet~     known whether interferon alfa following surgery is more effective than surgery alone in~     treating patients with melanoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with no~     further therapy following surgery in treating patients with stage II, stage III, or recurrent~     melanoma.~   "
265425|NCT00002788|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of high-dose combination chemotherapy~     followed by total-body irradiation and peripheral stem cell transplantation in treating~     patients with chronic lymphocytic leukemia.~   "
265412|NCT00082550|"~     This study will compare serotonin transporters in patients with obsessive-compulsive disorder~     (OCD) and healthy volunteers in order to better understand the role of serotonin in OCD.~     Serotonin is a chemical in the brain that transmits nerve impulses. The serotonin transporter~     (SERT) is a protein that regulates serotonin levels in the brain.~      Normal, healthy volunteers and patients with OCD between 18 and 50 years of age and in~     overall good health may be eligible for this study. Candidates are screened with a medical~     history, physical examination, blood and urine tests, and a psychological interview and tests~     related to OCD symptoms. Participants undergo the following tests:~        -  Positron emission tomography (PET) scanning: For this test, subjects lie on the scanner~          bed, wearing special masks that are fitted to their heads and attached to the beds to~          help keep their heads still during the procedure. An 8-minute transmission scan is~          done to provide measures of the brain that will help calculate information obtained from~          subsequent scans. Then, a radioactive tracer is injected into a catheter (plastic tube)~          placed in the arm. The scan produces images of the serotonin transporters in the brain.~          Pictures are taken for about 2 hours, while the subject lies still on the scanner bed.~        -  Magnetic resonance imaging (MRI) scanning: An MRI scan of the brain is done within 1~          year of the PET scan-that is, up to 1 year before or 1 year after the PET scan. MRI uses~          a magnetic field and radio waves to produce images of body tissues and organs. For this~          procedure, the patient lies on a table that is moved into the scanner (a narrow~          cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur~          during the scanning process. The procedure lasts about 1 hour, during which the patient~          will be asked to lie still for up to a few minutes at a time.~        -  Genotyping: Subjects provide a blood sample (4 tablespoons) for DNA testing to look for~          genes or gene regions that may contribute to serotonin activity. This may lead to a~          better understanding of the genetic underpinnings of the serotonin system that influence~          mood, movement, and addiction.~   "
265413|NCT00082498|"~     New treatment options are critical for treatment-experienced HIV infected patients with drug~     resistance. HIV entry inhibitors have been shown effective in patients with resistance to~     other anti-HIV drugs. This study will test the safety and effectiveness of three different~     doses of vicriviroc (formerly known as Schering D, SCH-D, or SCH 417690) in HIV infected~     patients.~   "
265414|NCT00082485|"~     The purpose of this study is to assess the efficacy and safety of baclofen for the treatment~     of cocaine dependence.~   "
265415|NCT00082472|"~     This study is intended to show whether inhaled chemotherapy can be added to a standard IV~     chemotherapy regime, to investigate the additional toxicities and to show initial evidence of~     efficacy of the combination.~   "
265416|NCT00082459|"~     The goal of this trial is to determine the safety of HSPPC-96 and which route of~     administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic~     agent made from an individual patient's tumor.~   "
265417|NCT00082420|"~     To determine vitamin A value of beta-carotene in oil capsule, spinach, and golden rice.~      The experiments will be conducted in children (ages 7-9) with/without adequate vitamin A~     nutrition. As plant provitamin A carotenoids are a major and safe vitamin A source for a vast~     population in the world, it is essential to determine the efficiency of provitamin A~     carotenoid (mainly ß-C) conversion to vitamin A. By introducing ß-C into rice endosperm,~     Golden Rice may directly benefit consumers by providing vitamin A nutrition. Our~     investigation uses hydroponically grown, deca-deuterium labeled spinach and Golden Rice,~     synthetic ß-C-d10 and a vitamin A isotope reference, deca-deuterated retinyl acetate~     (RAc-d10), to evaluate the bioavailability and the bioconversion of plant provitamin A~     carotenes to retinol as compared with ß-C in oil capsules in vivo.~      Our objectives will be to test the following hypotheses and to make the following~     determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by~     children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The~     absorption of provitamin A carotenes and their bioconversion to vitamin A are different in~     children with or without adequate vitamin A nutrition. (3) To define the vitamin A~     equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope~     reference method in children with or without adequate vitamin A nutrition and to compare~     those values with values derived from model based compartmental analysis. (4) To determine~     the number and time of blood samples needed for future studies in various field settings on~     the retinol equivalence of a large number of plant sources.~      This study will be of importance in planning vitamin A deficiency prevention strategies and~     also will provide useful information regarding the potential efficacy of a bioengineered crop~     to provide vitamin A nutrition.~   "
265418|NCT00002870|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. It~     is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more~     effective than standard therapy for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy~     plus peripheral stem cell transplantation with that of standard therapy in treating women who~     have locally recurrent or metastatic breast cancer.~   "
265419|NCT00002826|"~     RATIONALE: Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with a~     chemotherapy drug may reduce resistance to the drug, and allow the tumor cells to be killed.~      PURPOSE: Phase II trial to study the effectiveness of PSC 883 and paclitaxel in treating~     women who have recurrent or metastatic breast cancer.~   "
265420|NCT00002803|"~     RATIONALE: Sometimes neuroblastoma will regress without treatment, but sometimes additional~     treatment may be necessary. Giving more than one chemotherapy drug after surgery to remove~     the tumor may kill more tumor cells.~      PURPOSE: Phase II trial to study combination chemotherapy or observation following surgery in~     treating infants with neuroblastoma.~   "
265421|NCT00002802|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow~     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation~     therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment~     regimen is most effective in treating patients with different stages of and risk factors for~     neuroblastoma.~      PURPOSE: Phase III trial to study the effectiveness of therapy based on stage of disease and~     risk assessment in treating children with neuroblastoma.~   "
265422|NCT00082446|"~     The overall goals of this study are to expand the available data on the safety and~     immunogenicity of MVA-BN in vaccinia-naive adults and to determine the optimum dose of MVA-BN~     to induce immune responses and attenuate Dryvax take reactions. Participants will include 90~     healthy volunteers, ages 18-32 years. Participants will be randomly assigned to 1 of 6 study~     groups (groups A-F). Participants will be involved in study related procedures for up to 2~     years. During this time, volunteers will return periodically for blood draws to check immune~     responses.~   "
265423|NCT00082433|"~     The purpose of this clinical research study is to learn if BMS-247550 added to the approved~     therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine~     alone in women with metastatic breast cancer. Patients should have previously received an~     anthracycline and a taxane. The safety of this treatment will also be studied.~   "
265424|NCT00082381|"~     This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial~     to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as~     measured by hemoglobin A1c (HbA1c).~   "
265592|NCT00081822|"~     The purpose of this study is to determine the recommended phase II dose of clofarabine when~     administered in combination with standard dose Ara-C to older (>=60 years of age) patients~     with newly diagnosed acute myeloid leukemia (AML).~   "
265426|NCT00002737|"~     RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the~     growth of kidney cancer. Isotretinoin may help kidney cancer cells develop into normal cells.~     It is not yet known whether interferon alfa plus isotretinoin is more effective than~     interferon alfa alone for kidney cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or~     without isotretinoin in treating patients who have metastatic kidney cancer.~   "
265427|NCT00002677|"~     Phase I trial to study the effectiveness of tributyrin in treating patients with refractory~     stage IV prostate cancer or other solid tumors. Drugs used in chemotherapy use different ways~     to stop tumor cells from dividing so they stop growing or die.~   "
265428|NCT00002644|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the uptake of estrogen.~      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of tamoxifen~     with a placebo in preventing breast cancer in women at high risk.~   "
265429|NCT00002587|"~     Phase I trial to study the effectiveness of paclitaxel plus topotecan in treating patients~     who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~   "
265430|NCT00082407|"~     This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect~     of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as~     measured by hemoglobin A1c (HbA1c).~   "
265431|NCT00082394|"~     The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe,~     tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and~     atazanavir administered once daily. Over the course of 48 weeks, various parameters that~     measure safety, tolerability and efficacy of the investigational drugs were measured and~     compared.~   "
265432|NCT00082316|"~     This study is a randomized, open-label multi-center evaluation of the tolerability of~     treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4%~     lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe~     neuropathic pain secondary to painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN)~     or HIV-associated neuropathy (HIV-AN), with average numeric pain rating scale (NPRS) scores~     during screening of 3 to 8 (inclusive).~   "
265433|NCT00082368|"~     Background:~        -  Tc-94m sestamibi is a radioactive imaging drug approved by the Food and Drug~          Administration to help photograph and study bodily functions.~        -  Tc-94m sestamibi accumulates in tumor cells and is eliminated from them in much the same~          way that some chemotherapy drugs are eliminated from cancer cells in patients with drug~          resistance.~        -  P-glycoprotein is a protein found on the surface of some cancer cells. The protein~          causes the cells to pump out, or reject, some types of chemotherapy drugs.~          P-glycoprotein also makes the cells reject sestamibi.~        -  Some drugs, including a drug called tariquidar, may block the pumping action of~          P-glycoprotein, giving the chemotherapy more time to work. Tariquidar can also help~          sestamibi stay in the cells longer.~      Objectives:~      -To evaluate the use of sestamibi for determining if chemotherapy is being rejected and if~     enough of the blocking drugs are present to stop the rejection.~      Eligibility:~      -Patients18 years of age and older with a tumor 2 cm or larger who are enrolled in or are~     eligible for enrollment in an active National Cancer Institute treatment protocol.~      Design:~        -  Patients have two scans, one before receiving any drugs and a second 1-2 hours after~          receiving tariquidar. The second scan is done 72 or more hours after the first. For both~          scans, Tc-94m sestamibi is injected into a vein and a series of pictures are taken with~          an imaging camera called a PET (positron emission tomography) scanner. The pictures show~          where the sestamibi distributes in the body and monitors the effects of tariquidar on~          drug resistance. Blood samples are collected during the scan to examine the effect of~          tariquidar on P-glycoprotein in normal cells.~        -  Some patients may be asked to undergo a tumor biopsy to test for the presence of the~          P-glycoprotein on their cancer cells. This will be requested only in patients whose~          tumor is easily accessible and in whom a biopsy can be done with minimal risk.~   "
265434|NCT00082355|"~     This study will test the effectiveness of low-dose recombinant tissue plasminogen activator~     (rtPA, or alteplase) in dissolving blood clots in deep leg veins. Alteplase is used to clear~     blood clots in coronary arteries in patients having heart attacks. Blood clots can develop in~     the deep leg veins causing pain and swelling and may break loose and lodge in the lungs.~     Current routine treatments use anticoagulants such as heparin stop the clots from enlarging~     and prevent clots from moving to the lung but do not reliably dissolve clots in the leg.In an~     earlier study we showed that rtPA could be used to actually dissolve the clots. This study~     will determine whether lower doses of rtPA can dissolve clots with fewer bleeding~     complications than the current higher-dose regimens.~      Patients 18 years of age and older who have blood clots in a deep vein of the pelvis or leg~     may be eligible for this study if they have had symptoms for 14 days or less and if they have~     never had clots in their deep veins before.~      Participants are admitted to hospital for up to 5 days. On the first treatment day, the~     patient has a venogram to show the location of the clots. The radiologist injects an x-ray~     contrast material into a small vein in the foot and watches the dye by x-ray as it moves up~     the leg, revealing the clot(s). A catheter (plastic tube) is then inserted into a vein either~     behind the knee, in the groin, or in the neck, and advanced until it reaches the clots. When~     the catheter is in place, rtPA is injected while the radiologist watches the vein under the~     x-ray image. The amount of rtPa needed will depends on the size of the clot. Up to five~     venograms may be done if the clot requires the maximum four rtPA treatments allowed in this~     study. During the treatments, patients receive standard doses of heparin, given continuously~     by vein, After completion of treatments, anticoagulation is continued through use of a low~     molecular weight heparin (usually enoxaparin) given by subcutaneous injection as a transition~     medication during conversion to anticoagulation with warfarin ( also known as coumadin),~     another blood thinner, taken by mouth. Patients continue taking warfarin for 6 months.~      During thrombolytic therapy, blood samples are drawn shortly before the first dose of rtPA~     and at five time points afterward to measure the rtPA in the circulation and other factors~     that indicate whether the rtPA is affecting clotting ability. Blood also is drawn at least~     once a day to monitor heparin levels.~      To evaluate the impact of treatment on the function of the leg, patients return to the~     Rehabilitation Medicine Department and Radiology department at about 6 weeks (4 to 8 week )~     and 6 months for clinical and imaging evaluation of impact of therapy on venous function.~      The objectives are to determine how well this treatment will restore venous function and~     whether this can be done safely- without causing bleeding complications, which have been the~     main risks of previous thrombolytic treatments.~   "
265435|NCT00082342|"~     This study will examine the effects of transcranial direct current stimulation (tDCS) on gait~     (walking) problems and rigidity in patients with Parkinson's disease. tDCS is a method of~     brain stimulation that may be able to change the electrical activity of the nerves of the~     brain, possibly causing Parkinson's disease symptoms to improve.~      Patients between 40 and 80 years of age with moderately severe Parkinson's disease whose main~     symptoms are problems with walking, including freezing, or rigidity, may be eligible for this~     study. Candidates must be taking Sinemet or another L-DOPA drug and not have too much tremor.~      Participants will be assigned to receive either real or sham (placebo) tDCS. Both groups will~     have eight treatments over 3-1/2 weeks. For the tDCS, electrodes are placed on wet pads on~     the scalp. An electrical current passes through the electrodes, travels through the scalp and~     skull, and causes small electrical currents in the cortex-the outer part of the brain.~     Participants will have a neurological examination, including an evaluation of walking, just~     before and just after each tDCS session. Patients' motor function will be re-evaluated at 1,~     3, and 6 months after the last tDCS treatment.~   "
265464|NCT00006053|"~     RATIONALE: STI571 may interfere with the growth of cancer cells and may be effective~     treatment for chronic myelogenous leukemia.~      PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have~     chronic myeloid leukemia that has not responded to interferon alfa.~   "
265436|NCT00082329|"~     This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating~     factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than~     the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell~     donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation~     for collection for transplantation. Although a sufficient quantity of cells usually can be~     collected with G-CSF treatment, some donors do not respond well and may require multiple~     apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used~     together with a drug called AMD3100 may be more effective in mobilizing stem cells for~     collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem~     cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers~     within a few hours.~      Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.~   "
265437|NCT00082303|"~     The purpose of this study is to explore the effect of music imagery on patients receiving~     intensive chemotherapy for acute leukemia or high-grade non-Hodgkin’s lymphoma.~   "
265438|NCT00082290|"~     RATIONALE: Massage therapy may help lessen pain caused by cancer.~      PURPOSE: This randomized phase II trial is studying how well massage therapy works in~     treating patients with cancer pain.~   "
265439|NCT00082277|"~     The purpose of this study is to evaluate safety parameters of anastrozole with regard to its~     potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted~     to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal~     women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer~     and who are high or moderate risk of fragility fracture. It is also conducted to determine~     the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at~     low risk of fragility fracture.~   "
265440|NCT00082251|"~     The purpose of this study is to compare the effectiveness and safety of different doses of~     Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood~     (dyslipidemia).~   "
265441|NCT00082238|"~     People with CF have a high incidence of diabetes, called CFRD. CFRD is an important cause of~     worsened morbidity and mortality, thus understanding the pathophysiology underlying its~     development is imperative. Insulin deficiency has been well recognized as one cause of CFRD;~     however the clinical presentation and studies of pathogenesis indicate that the etiology is~     more complex. There is strong evidence that normal metabolism of carbohydrate, protein and~     fat is altered in CF. We believe that the inflammatory response to chronic underlying lung~     disease is responsible for insulin resistance and alters substrate metabolism, and that these~     changes, in addition to insulin deficiency cause CFRD. Our global hypothesis is that~     hyperglycemia is caused, in part, by high rates of gluconeogenesis resulting from excessive~     amino acid substrate availability caused by cytokine-mediated protein catabolism. We further~     hypothesize that inflammation alters normal fatty acid metabolism leading to lipogenesis, an~     energy wasteful pathway. We will recruit 24 adult CF subjects and 10 controls (similar in~     distribution in lean tissue mass, age and gender) and will categorize them according to~     glucose tolerance (OGTT), as well as insulin secretion and insulin sensitivity using the~     Tolbutamide-stimulated IVGTT and the Minimal Model. Clinical status will be characterized by~     measuring pulmonary function and modified NIH scores, in addition to measuring levels of~     circulating cytokines. Gluconeogenesis (GNG) will be quantified by measuring the~     incorporation 2H into the 2nd, 5th and 6th carbons of glucose. Amino acid turnover rates will~     be measured using stable isotopes of lactate and alanine and whole body protein turnover~     (WBPT) will be measured using [1-13C]leucine and [15N2]urea. Fat metabolism will be evaluated~     by measuring ketone body turnover using stable isotopes, and by quantifying lipogenesis using~     the isotopomer equilibration method. Key enzymes of fatty acid metabolism will also be~     measured. We will utilize indirect calorimetry to measure resting energy expenditure.~     Subjects will be recruited from the CF centers at the University of Texas- Southwestern and~     the South Central CF Consortium.~   "
265442|NCT00082225|"~     Patients have a type of cancer called Hodgkin's lymphoma or non-Hodgkin's lymphoma, which has~     come back or not gone away or is at high risk for coming back after treatment, including the~     best treatment investigators know for this disease. Investigators are asking the patient to~     volunteer to be in a research study using a new experimental therapy consisting of special~     immune system cells called LMP2 specific cytotoxic T lymphocytes in combination with a~     special protein called a monoclonal antibody.~      Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus~     that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their~     diagnosis of the lymphoma. EBV is found in the cancer cells of up to half the patients with~     lymphoma, suggesting that it may play a role in causing lymphoma. The cancer cells infected~     by EBV are able to hide from the body's immune system and escape destruction. Investigators~     want to see if special white blood cells, called T cells, that have been trained to kill EBV~     infected cells can survive in the blood and affect the tumor.~      The investigators have used this sort of therapy to treat a different type of cancer that~     occurs after bone marrow and solid organ transplant called post transplant lymphoma. In this~     type of cancer the tumor cells have 9 proteins made by EBV on their surface. They grew T~     cells in the laboratory that recognized all 9 proteins and were able to prevent and treat~     post transplant lymphoma. However in Hodgkin disease and non-Hodgkin Lymphoma the tumor cells~     only express 2 EBV proteins. In a previous study investigators made T cells that recognized~     all 9 proteins and gave them to patients with Hodgkin disease. Some patients had a partial~     response to this therapy but no patients had a complete response. Investigators think one~     reason may be that many of the T cells reacted with proteins that were not on the tumor~     cells. They are now trying to find out if they can improve this treatment by growing T cells~     that only recognize one of the proteins expressed on Lymphoma cells called LMP-2. These~     special T cells are called LMP-2 specific cytotoxic T-lymphocytes (CTLs).~      In this study investigators also are trying to see if they can improve these results by~     treating patients first with a special protein called an antibody and then giving the EBV~     specific T cells. The reason for doing this is that EBV specific T cells have worked very~     well in bone marrow transplant patients to prevent and treat EBV cancers. These patients have~     very few of their own immune cells when they are given the trained T cells and therefore~     there is a lot of space for the trained cells to grow. Investigators hope that they can~     improve the effect of the trained T cells in Hodgkin disease and non-Hodgkin Lymphoma~     patients by first temporarily removing the patient's own T cells before giving the trained~     cells.~   "
265443|NCT00082212|"~     The purpose of this study is to determine the overall response rate, time to progression, and~     1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma.~   "
265444|NCT00014651|"~     RATIONALE: Drugs such as vapreotide may prevent complications following pancreatic resection.~     It is not yet known if vapreotide is more effective than no further therapy in preventing~     side effects of pancreatic resection.~      PURPOSE: This randomized phase III trial is studying vapreotide to see how well it works~     compared to a placebo in preventing complications in patients undergoing surgery for~     pancreatic cancer.~   "
265445|NCT00010322|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Toremifene may fight~     breast cancer by blocking the uptake of estrogen by the tumor cells. Atamestane may fight~     breast cancer by blocking the production of estrogen. It is not yet known if toremifene is~     more effective with or without atamestane.~      PURPOSE: Randomized phase III trial to compare the effectiveness of toremifene with or~     without atamestane in treating postmenopausal women who have metastatic breast cancer.~   "
265446|NCT00008255|"~     RATIONALE: Doctors can diagnose lung cancer by collecting mucus coughed up from the lungs and~     examining it under a microscope to look for cancer cells. Breathing in INS316 may make it~     easier for patients to cough up mucus.~      PURPOSE: Randomized phase II trial to study the effectiveness of INS316 in helping to~     diagnose lung cancer.~   "
265465|NCT00006039|"~     RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the~     growth of non-Hodgkin's lymphoma.~      PURPOSE: Phase II trial to study the effectiveness of interferon alfa-2b in treating patients~     who have advanced low-grade non-Hodgkin's lymphoma.~   "
265447|NCT00002568|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug or combining chemotherapy with surgery~     may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     consisting of paclitaxel and cisplatin with or without surgery in treating patients with~     stage III ovarian epithelial cancer.~   "
265448|NCT00002516|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug with surgery and radiation therapy may kill more tumor cells. It~     is not yet known which combination chemotherapy regimen is most effective in treating~     patients with Ewing's sarcoma.~      PURPOSE: Randomized phase III trial to compare various combination chemotherapy regimens plus~     surgery and radiation therapy in treating patients who have Ewing's sarcoma.~   "
265449|NCT00082199|"~     The purpose of this clinical research study is to learn whether subjects treated with~     aripiprazole are able to abstain from alcohol use for a greater number of days than subjects~     treated with placebo. The safety of using aripiprazole will also be studied.~   "
265450|NCT00082186|"~     The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on~     testicular function via semen analysis in male patients with primary pulmonary arterial~     hypertension (PAH).~   "
265451|NCT00082173|"~     Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and~     then two drugs for 4 months. New drug regimens that are shorter and effective against~     drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin~     (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively~     treat TB.~   "
265452|NCT00082160|"~     The purpose of this study is to use brain imaging technology to identify the parts of the~     brain that are activated during meditation and to compare these parts to those activated~     during other activities. This study will also determine the effects of meditation on~     involuntary functions, such as breathing.~   "
265453|NCT00082134|"~     This is a Phase II, non-randomized, open label study of ILX651 in patients with~     hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40~     patients will be enrolled in this study that is expected to last 24 months. All patients will~     be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The~     primary objective of this study is to determine the PSA response rate. The secondary~     objectives are to determine response of measurable disease, duration of response, time to PSA~     progression, time to treatment failure, survival, safety and tolerability, and~     pharmacokinetic profile of ILX651.~   "
265454|NCT00082121|"~     The purpose of this study is to determine if the study drug (TP10), which blocks complement~     release, can reduce such side effects of complement inflammation as chest pain or heart~     attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.~   "
265455|NCT00011934|"~     RATIONALE: Biological therapy may increase the number of immune cells found in bone marrow~     and may help a person's immune system recover from the side effects of the chemotherapy used~     in treating chronic myeloid leukemia. Bone marrow transplantation may be able to replace~     immune cells that were destroyed by chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation,~     chemotherapy, and biological therapy in treating patients who have chronic myeloid leukemia.~   "
265456|NCT00008242|"~     RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the~     cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from~     dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more~     cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of thalidomide, doxorubicin, and~     dexamethasone in treating patients who have untreated stage II or stage III multiple myeloma.~   "
265457|NCT00008125|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of gemcitabine combined with docetaxel and~     carboplatin with or without filgrastim in treating patients who have advanced solid tumors.~   "
265458|NCT00008099|"~     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with resected or locally advanced unresectable pancreatic cancer.~   "
265459|NCT00006682|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vinorelbine combined with docetaxel in~     treating women who have metastatic breast cancer.~   "
265460|NCT00006669|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to kill cancer cells. Combining monoclonal antibody therapy~     with chemotherapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab followed by combination~     chemotherapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.~   "
265461|NCT00006342|"~     RATIONALE: Determination of genetic markers for leukemia or non-Hodgkin's lymphoma that is~     secondary to Hodgkin's disease and childhood brain tumors may help doctors to identify~     patients who are at risk for these cancers.~      PURPOSE: Clinical trial to determine the presence of certain genes in patients who are~     receiving treatment for Hodgkin's disease or childhood brain tumors.~   "
265462|NCT00006112|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of fluorouracil with or~     without mitomycin in treating patients who have peritoneal cancer.~   "
265463|NCT00006097|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of CC-1088 in treating patients who have~     chronic lymphocytic leukemia that has not responded to previous therapy.~   "
265466|NCT00005988|"~     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the~     transplanted cells can make an immune response against the body's normal tissues. Treatment~     of the donor bone marrow with the patient's white blood cells and a monoclonal antibody may~     prevent this from happening.~      PURPOSE: Phase I trial to study the effectiveness of bone marrow transplantation with~     specially treated bone marrow in treating patients who have hematologic cancer that has not~     responded to previous therapy.~   "
265467|NCT00005974|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who~     have recurrent, locally advanced, or metastatic soft tissue sarcoma.~   "
265468|NCT00005871|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether nitrocamptothecin is more effective~     than fluorouracil for pancreatic cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with~     that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer~     and who have been treated previously with gemcitabine.~   "
265469|NCT00005612|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with autologous peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation in treating patients who have ovarian epithelial cancer.~   "
265470|NCT00005594|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have~     advanced cancer of the pancreas.~   "
265471|NCT00005081|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining carmustine and~     O6-benzylguanine in treating patients who have recurrent or progressive glioma.~   "
265472|NCT00005055|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Hydration with saline solution may protect kidney cells from the~     side effects of chemotherapy.~      PURPOSE: Randomized phase II trial to study the effectiveness of glufosfamide with or without~     hydration in treating patients who have advanced non-small cell lung cancer.~   "
265473|NCT00005053|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Hydration with a saline solution may protect kidney cells from the~     side effects of chemotherapy.~      PURPOSE: Randomized phase II trial to compare the effectiveness of glufosfamide with or~     without hydration in treating patients who have pancreatic cancer that is metastatic or~     cannot be removed by surgery.~   "
265474|NCT00005021|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug, giving the drugs in different~     ways, and combining biological therapy with chemotherapy may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of topotecan, paclitaxel, and carboplatin~     with or without filgrastim in treating patients who have advanced solid tumor or lymphoma~     that has not responded to standard therapy.~   "
265475|NCT00004893|"~     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by~     stimulating a person's white blood cells to kill breast cancer cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of interleukin-12 in treating~     patients who have metastatic or recurrent breast cancer.~   "
265476|NCT00004892|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving drugs in different ways may~     kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of O6-benzylguanine and implanted~     carmustine wafers in treating patients who have recurrent malignant glioma.~   "
265477|NCT00004884|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin~     in treating advanced pancreatic cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine~     with that of docetaxel and cisplatin in treating patients who have metastatic or locally~     advanced pancreatic cancer.~   "
265478|NCT00004246|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus fludarabine in~     treating patients who have locally advanced cancer of the mouth, pharynx, or larynx.~   "
265479|NCT00004230|"~     RATIONALE: Captopril may protect the lungs from the side effects of bone marrow or stem cell~     transplantation.~      PURPOSE: Randomized phase III trial to determine the effectiveness of captopril to lessen the~     side effects in patients who are undergoing bone marrow or stem cell transplantation~     following chemotherapy and radiation therapy.~   "
265480|NCT00004213|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of 3-aminopyridine-2-carboxaldehyde~     thiosemicarbazone in treating patients who have solid tumors that have not responded to~     previous treatment.~   "
265481|NCT00004101|"~     Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients~     who have recurrent non-Hodgkin's lymphoma. Monoclonal antibodies can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~   "
265482|NCT00004049|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have~     locally advanced or metastatic solid tumors that have not responded to previous treatment.~   "
265483|NCT00003972|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It~     is not yet known which regimen of combination chemotherapy is more effective for breast~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of~     combination chemotherapy followed by peripheral stem cell transplantation in treating~     patients who have stage II or stage IIIA breast cancer.~   "
265484|NCT00003968|"~     Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have~     metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die.~   "
265485|NCT00003943|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients who have metastatic cancer.~   "
265486|NCT00003900|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and docetaxel in~     treating patients who have recurrent or metastatic non-small cell lung cancer.~   "
265487|NCT00003849|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them.~      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have~     non-Hodgkin's lymphoma or Hodgkin's disease.~   "
265488|NCT00003825|"~     RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation~     therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more~     effective than no further therapy for treating gastrointestinal disturbance caused by~     previous radiation therapy.~      PURPOSE: Randomized phase III trial to determine the effectiveness of pentosan polysulfate in~     treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by~     previous radiation therapy to the abdomen and pelvis.~   "
265489|NCT00003768|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating~     patients who have advanced solid tumors that have not responded to previous therapy.~   "
265490|NCT00003726|"~     RATIONALE: Anticoagulants, such as lepirudin, may help prevent blood clots from forming in~     patients who have received chemotherapy for small cell lung cancer.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of lepirudin in~     treating patients with recurrent or advanced small cell lung cancer.~   "
265491|NCT00003713|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of intoplicine in treating patients who~     have advanced or metastatic solid tumors.~   "
265492|NCT00003680|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It~     is not yet known whether high-dose chemotherapy plus peripheral stem cell transplantation is~     more effective than standard chemotherapy for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of standard chemotherapy~     with that of high-dose chemotherapy plus peripheral stem cell transplantation in treating~     women who have advanced breast cancer or inflammatory breast cancer.~   "
265493|NCT00003646|"~     RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an~     immune response that will kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who~     have stage III or stage IV melanoma that has not responded to previous treatment.~   "
265494|NCT00003638|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Vaccines may make the body build an immune response to kill tumor~     cells. It is not yet known whether THERATOPE vaccine therapy is more effective than standard~     vaccine therapy in treating metastatic breast cancer.~      PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of THERATOPE~     vaccine therapy with that of standard vaccine therapy in treating women who have metastatic~     breast cancer.~   "
265495|NCT00003622|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of vinorelbine plus paclitaxel in treating~     patients with metastatic prostate cancer that is refractory to hormone therapy.~   "
265496|NCT00082147|"~     This study will examine the usefulness of an imaging procedure called dynamic~     contrast-enhanced magnetic resonance imaging (DCE-MRI) for localizing and characterizing~     prostate cancer. For this test, a medicine is injected into a vein and the MRI measures how~     the medicine flows through the prostate gland. The measurements provide information about the~     blood vessels in the prostate gland, which provides other information about the cancer.~     Several needle biopsies are performed during the procedure, and the results of the biopsies~     are compared with the information from the DCE-MRI.~      Men 18 years of age and older with suspected or confirmed prostate cancer may be eligible for~     this study. Candidates are screened with a medical history and physical examination, blood~     test, and review of tumor pathology.~      Participants undergo DCE-MRI and needle biopsies of the prostate. The day before and the~     morning of the procedure, patients are given an antibiotic called Levofloxacin. They also~     have a small enema the morning of the test. A local anesthetic is then given in the area~     around the prostate to numb the tissue and decrease any discomfort from the procedure. A tube~     is placed in the rectum to obtain better pictures of the prostate gland during the imaging.~     During the scan, the patient may be asked to breathe air that contains higher concentrations~     of oxygen and carbon dioxide than are in room air. The MRI scans guide the physician in~     selecting areas of the prostate to biopsy. For each biopsy, a needle is placed through the~     rectum into the prostate gland. When the needle is in place, a small tissue sample is~     withdrawn. This procedure is repeated until 4 to 10 biopsies are taken. During the procedure,~     which lasts about 1 hour, the patient lies on his stomach on a stretcher.~      Patients who are planning to undergo surgery or radiation treatment for their cancer at the~     NCI may have up to four 1-mm non-reactive gold markers placed in the prostate during the~     DCE-MRI procedure. The markers are left in place to help target the radiation treatments and~     to show where the biopsies were taken if the prostate is removed.~      At the end of the procedure, the patient is moved to a bed to recover and may get up and~     urinate after about 30 to 60 minutes. After a period of observation, the patient is~     discharged home with a dose of antibiotic to take the next day.~      Some patients may be asked to repeat the MRI and biopsy procedure during or after their~     treatment for prostate cancer to help investigators learn whether the MRI test is still~     helpful after treatment. Repeat testing is optional.~   "
265497|NCT00082108|"~     Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are inherited~     disorders characterized by progressive muscle weakness and loss of muscle tissue. The purpose~     of this registry is to connect people with DM or FSHD with researchers studying these~     diseases. The registry will offer individuals with DM and FSHD an opportunity to participate~     in research that focuses of their diseases. The registry will also help scientists to~     accomplish research on DM and FSHD and to distribute their findings to patients and care~     providers.~   "
265498|NCT00082095|"~     The main purpose of this study is to compare treatment with either pegylated liposomal~     doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women~     60 years and older.~   "
265499|NCT00082082|"~     The objective of this Phase II trial is to compare the efficacy and safety of 6 months of~     treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in~     adult patients with non-surgical hepatocellular carcinoma (HCC).~   "
265500|NCT00082069|"~     The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses~     spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their~     order of enrollment with consideration of their availability to complete the necessary~     vaccinations and follow-up visits.~   "
265501|NCT00081978|"~     The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse~     Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered~     twice daily for 48 weeks.~   "
265502|NCT00003583|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Drugs such as amifostine may protect normal cells from the side~     effects of chemotherapy and radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of amifostine to prevent side effects in~     patients who are receiving chemotherapy and radiation therapy for limited-stage small cell~     lung cancer.~   "
265503|NCT00003563|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gadolinium~     texaphyrin may increase the effectiveness of radiation therapy by making tumor cells more~     sensitive to radiation. It is not yet known whether giving gadolinium texaphyrin with~     radiation therapy is more effective than radiation therapy alone in treating brain~     metastases.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without gadolinium texaphyrin in treating patients who have brain metastases.~   "
265504|NCT00003554|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them.~      PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab in~     treating patients with multiple myeloma that is newly diagnosed.~   "
265505|NCT00003397|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing~     substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation~     plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.~   "
265506|NCT00003394|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting~     of estramustine, paclitaxel, and carboplatin in treating patients with advanced prostate~     cancer.~   "
265507|NCT00003276|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with~     advanced gallbladder or bile duct cancer that cannot be removed surgically.~   "
265508|NCT00003239|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining biological therapy with chemotherapy may kill more~     cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with cytarabine and~     homoharringtonine and biological therapy with interferon alfa in treating patients with~     chronic phase chronic myelogenous leukemia.~   "
265509|NCT00003181|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill~     cancer cells. Combining chemotherapy with interleukin-2 and GM-CSF may be a more effective~     treatment for kidney cancer.~      PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2, vinblastine,~     and GM-CSF in treating patients with metastatic kidney cancer.~   "
265510|NCT00003175|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of fluorouracil given as a continuous~     infusion in treating patients with recurrent or metastatic bladder cancer.~   "
265511|NCT00003165|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs in different forms may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of doxorubicin in treating women with~     advanced metastatic breast cancer.~   "
265512|NCT00003133|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following~     surgery in treating patients with advanced bladder cancer.~   "
265513|NCT00003038|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with suramin~     plus doxorubicin in treating patients with advanced solid tumors.~   "
265514|NCT00003019|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with vinblastine and~     methotrexate in treating children who have desmoid tumors that are recurrent or untreatable~     with surgery or radiation therapy.~   "
265515|NCT00081939|"~     There have been two previous Total Therapy studies for multiple myeloma (MM) at the Myeloma~     Institute for Research and Therapy (MIRT): Total Therapy I (from 1989 through 1994) and Total~     Therapy II (from 1996 to 2004). Results have shown that patients treated on these studies had~     better outcomes (meaning patients have lived longer and had better responses to treatment)~     when compared to patients treated with standard chemotherapy.~      With this new study, Total Therapy III, researchers will take what they have learned from the~     first two studies and add new treatment strategies to try to improve the outcomes even more,~     especially for patients with chromosome abnormalities.~   "
265516|NCT00081926|"~     This study will evaluate the molecular response to high dose Gleevec in newly diagnosed~     patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase. This study will evaluate~     the ability of Gleevec to reduce the amount of abnormal protein that occurs in patients with~     CML.~      Patients who are eligible to participate will be treated for 18 months. This trial will~     include male or female patients 18 years or older who are newly diagnosed (within 6 months)~     with CML.~   "
265517|NCT00014365|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase I trial to determine if Ro 31-7453 is more effective with or~     without food in treating patients who have metastatic solid tumors.~   "
265518|NCT00006483|"~     RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune~     cells found in bone marrow or peripheral blood and may be an effective treatment for patients~     with kidney cancer that has spread to the lung.~      PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who~     have kidney cancer that has spread to the lung.~   "
265519|NCT00006261|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune~     cells that were destroyed by chemotherapy. Donor lymphocytes may attack and destroy cancer~     cells.~      PURPOSE: This phase II trial is studying the effectiveness of combination chemotherapy,~     peripheral stem cell transplantation, and donor lymphocyte infusion in treating women with~     stage IV breast cancer.~   "
265520|NCT00006106|"~     RATIONALE: A specially modified virus called ONYX-015 may be able to kill tumor cells while~     leaving normal cells undamaged. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Combining ONYX-015 with chemotherapy may~     kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of ONYX-015 combined with cisplatin and~     fluorouracil in treating patients who have advanced head and neck cancer.~   "
265521|NCT00003001|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting~     of fluorouracil, leucovorin, and gemcitabine in treating patients with recurrent or~     metastatic colorectal cancer.~   "
265522|NCT00002977|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of melphalan and thiotepa followed by~     peripheral stem cell transplantation in treating patients with stage III or stage IV~     epithelial ovarian cancer in complete remission.~   "
265523|NCT00002939|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan and paclitaxel in treating~     patients with metastatic or recurrent cancer.~   "
265524|NCT00002912|"~     Phase I trial to study the effectiveness of PSC-833 plus etoposide and mitoxantrone in~     treating children who have refractory or relapsed acute leukemia. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die. Some~     cancers become resistant to chemotherapy drugs. Combining PSC-833 with chemotherapy may~     reduce resistance to the drug and allow more cancer cells to be killed.~   "
265525|NCT00002884|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not yet known whether external-beam radiation therapy plus chemotherapy is more effective~     with or without internal radiation therapy.~      PURPOSE: Randomized phase III trial to compare chemotherapy and external-beam radiation~     therapy with or without internal radiation therapy in treating patients with stage I, stage~     II, or stage III esophageal cancer.~   "
265526|NCT00002773|"~     RATIONALE: Vaccines made from donated tumor cells treated with interferon alfa may make the~     body build an immune response to and kill pancreatic tumor cells. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die.~     Colony-stimulating factors may help a person's immune system recover from the side effects of~     chemotherapy. Combining these treatments may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy using donated~     tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide plus~     GM-CSF in treating patients with advanced pancreatic cancer.~   "
265527|NCT00002719|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number~     of immune cells found in the bone marrow or peripheral blood and may help a person's immune~     system recover after chemotherapy and radiation therapy. Combining more than one drug and~     giving drugs in different ways may kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without G-CSF in treating older patients with acute myeloid leukemia.~   "
265528|NCT00002680|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of sequential high-dose chemotherapy~     followed by peripheral stem cell transplantation in treating patients with metastatic breast~     cancer that is responding to chemotherapy.~   "
265530|NCT00002564|"~     RATIONALE: Dietary fat may be involved in the growth of cancer cells. Restricting dietary fat~     may help fight cancer.~      PURPOSE: Randomized clinical trial to study the effectiveness of a low fat diet in treating~     postmenopausal women who have stage I, stage II, or stage IIIA breast cancer that has been~     completely removed by surgery.~   "
265531|NCT00002481|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Bone marrow transplantation may allow doctors to give higher doses of radiation~     therapy and chemotherapy and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose etoposide and~     cyclophosphamide plus total-body irradiation followed by bone marrow transplantation in~     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.~   "
265532|NCT00082043|"~     This study will explore the effects of dutasteride on mood and the stress response across the~     menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate~     the stress response systems. These systems may be disturbed in women with menstrually related~     mood disorders (MRMD). The effects of the drug will be compared in women with and without~     MRMD to determine how neurosteroids regulate mood and the stress response across the~     menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign~     prostatic hyperplasia (excess growth of the prostate gland) in men.~      Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this~     study. Candidates are screened with a medical and psychiatric history, physical examination,~     screening for symptoms of depression, and routine blood and urine tests. Participants are~     required to use barrier contraception (condoms or diaphragm) during the 3-month study and~     6-month follow-up.~      Participants undergo the following tests and procedures:~        -  Dutasteride or placebo treatment: Participants receive 1 month of dutasteride and 2~          months of placebo. Neither the participants nor the investigators know when the subject~          is taking the active medication or the placebo.~        -  Biweekly follow-up visits: Every 2 weeks during the 3-month treatment period, patients~          come to the NIH Clinical Center to have blood drawn and to complete mood symptoms~          ratings.~        -  Monthly follow-up visits: Participants return to the Clinical Center once a month for 6~          months after the end of the treatment period to monitor hormone levels and pregnancy~          status.~   "
265533|NCT00082030|"~     This study will explore brain function related to depressive symptoms and will examine DNA~     for genes that may be involved in depressive disorders, particularly genes that regulate~     synthesis and metabolism of the brain neurotransmitter catecholamine. It will compare~     findings in patients with major depressive disorders who are in remission with those in~     normal, healthy volunteers.~      Patients with remitted major depressive disorders and healthy normal volunteers between 18~     and 60 years of age may be eligible for this study. Candidates are screened with a~     psychiatric and medical history, physical examination, electrocardiogram, and blood and urine~     tests. Participants undergo the following tests and procedures in up to eight visits to the~     NIH Clinical Center:~      Memory Tasks and Problem Solving and Brain Imaging~      Subjects are tested with measurements of intelligence or memory ability. They also undergo~     magnetic resonance imaging (MRI), a test that uses a magnetic field and radio waves to~     produce images of the brain. For this procedure, the patient lies on a table that is moved~     into the scanner (a narrow cylinder), and wears earplugs to muffle loud knocking and thumping~     sounds that occur during the scanning process. The MRI lasts about 60 minutes.~      Catecholamine Depletion Study~      For this study, subjects take capsules containing either AMPT (a drug that temporarily~     reduces brain catecholamine activity) or a placebo (lactose capsules, which do not affect~     brain catecholamine activity) at 9 a.m., 2 p.m., and 7 p.m. on one visit and return the next~     day to take additional capsules at 7 a.m. and noon. In addition to the study medication,~     subjects keep a low-monoamine diet (e.g., no chocolate, cheese, smoked meats, and various~     other foods that will be enumerated) and do not smoke, drink alcohol, or take in food or~     drink containing caffeine. After taking all the study capsules, the subjects have positron~     emission tomography (PET) and functional MRI (fMRI) scans, as follows:~        -  fMRI: While lying in the MRI scanner, the subject performs a monetary reward task that~          is somewhat like playing a computer video game for money. The amount of cash the subject~          can win depends on his or her performance. It is possible to lose money that was~          previously won, if performance declines. This portion of the study provides information~          on how the brain processes reward and about the role of catecholamines in this process.~        -  PET: The subject is injected in the arm with a glucose solution that has a radioactive~          substance attached that can be detected by the PET scanner. During the scan, the subject~          looks at photographs of faces on a computer screen and is asked to tell the gender of~          the persons. This test shows brain blood flow and measures brain glucose (sugar)~          metabolism, which reflects brain activity. At the end of the scan, subjects are asked~          about their mood and general well being. They return to the Clinical Center the~          following day for and evaluation of their emotional state.~      The catecholamine depletion study is repeated a second time 14 days or more after the first.~     Subjects who received AMPT capsules for the first study take lactose capsules for the second~     study, and vice-versa.~   "
265534|NCT00082017|"~     This study will examine the effects of an experimental drug called UCN-01~     (7-hydroxystaurosporine) on T-cell lymphomas. UCN-01 inhibits the growth of several different~     tumor cells, and, in laboratory studies, it has worked particularly well on tumor cells taken~     from patients with T cell lymphomas.~      Patients 9 years of age and older with T cell lymphoma that has relapsed or is not responding~     to chemotherapy may be eligible for this study. Candidates will be screened with a medical~     histories and physical examinations, blood and urine tests, electrocardiograms, chest x-rays,~     and computed tomography (CT) scans of the chest, abdomen and pelvis. Additional tests may be~     done if clinically indicated, such as positron emission tomography (PET) scans, bone marrow~     aspirations and biopsies, lumbar punctures (spinal taps) and CT's or magnetic resonance~     imaging (MRI) scans if there is evidence of central nervous system disease.~      Participants are given UCN-01 in 28-day treatment cycles. The drug is given by vein in a~     continuous 72-hour infusion on the first cycle and in 36-hour infusions on subsequent cycles.~     The total number of cycles patients receive depends on how well the tumor responds to the~     drug and how well the patient tolerates drug side effects. Patients who do well may receive~     treatment for up to 1 year. Patients whose disease worsens with treatment or who do not~     tolerate the therapy are taken off the study.~      Some or all of the screening tests are repeated periodically during the course of treatment~     to monitor safety and treatment response. X-rays and scans are done every other treatment~     cycle for the first 6 cycles and then, if the cancer is stable or improving, the interval~     between these imaging studies is lengthened to every 4 cycles. Patients whose tumors can be~     safely biopsied undergo this procedure before entering the study and 3 to 5 days after~     completing the first UCN-01 treatment. Biopsies requiring open surgery (e.g., in the chest or~     abdomen) are done only if absolutely necessary for medical care. Biopsy tissue, blood, and~     other fluids are analyzed for gene and protein studies related to lymphoma research.~   "
265535|NCT00081991|"~     This study will use dynamic light scattering (DLS) technology to study normal lens aging and~     early cataract formation. Cataract is a clouding of the lens that interferes with the passage~     of light to the retina, impairing visual acuity. DLS uses a low intensity laser light~     (similar to that used in supermarket checkouts) to measure lens cloudiness. It detects~     changes in the human lens at the earliest molecular stages of cataract development, when~     anti-cataract treatment would be most effective in reversing, delaying or preventing cataract~     formation.~      Healthy normal volunteers and patients with age-related cataract between 18 and 80 years of~     age may be eligible for this study. Participants undergo the following tests and procedures:~      Medical history~      Eye examination, including the following:~        -  Measurement of visual acuity (vision chart)~        -  Measurement of eye pressure~        -  Dilation of the pupils for slit lamp (microscope) examination and grading of lens~          opacity~        -  Ultrasound examination of the eye to determine distances between cornea, lens (including~          lens thickness), and retina~        -  Examination of the retina at the back of the eye~        -  Dynamic light scattering of the lens (see below)~        -  Lens photography using a camera with a bright flash~      For the DLS procedure, the patient sits in front of the DLS device with his or her chin~     placed on a chin rest and fixes on a yellow target in the center of the camera lens. When the~     eye is properly aligned, DLS measurements are taken on the lens.~   "
265536|NCT00081965|"~     RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not~     yet known whether acupuncture is more effective than a placebo in treating hot flashes in~     women with breast cancer~      PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works~     compared to a placebo in treating hot flashes in women with breast cancer.~   "
265537|NCT00081952|"~     The purpose of this study is to determine the safety, tolerability, and effectiveness of the~     amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women.~   "
265538|NCT00081913|"~     The purpose of this study is to determine if cell therapy with your own cells (autologous~     cells) delivered with a catheter to regions of the heart with poor blood flow will be safe~     and if it will relieve your chest pain and/or your ability to exercise.~   "
265555|NCT00081887|"~     Primary Objectives:~        1. To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic~          Leukemia (CLL).~        2. To determine the toxicity profile of clofarabine in CLL.~        3. To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology~          profile of clofarabine in CLL.~   "
265556|NCT00081874|"~     The goal of this clinical research study is to find the highest safe dose of RAD001 that can~     be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is~     to learn how effective the dose that is found is as a treatment.~   "
265539|NCT00081900|"~     Approximately 18-45 patients with Hepatocellular Carcinoma (HCC) will be treated with DENSPM~     at approximately 5 centers in the United States. First, we will be trying to determine the~     highest dose that can be given safely and is well tolerated (this is called the maximally~     tolerated dose, or the MTD, for short). Once that is established, we will enroll additional~     patients to learn more about potential side effects and to see whether DENSPM can slow the~     growth of HCC tumors. We also want to learn about the safety of DENSPM. Many medications used~     to treat cancer cause side effects (discomforts or illness). In this study, we want to~     understand what side effects occur in patients with HCC who are treated with DENSPM.Study was~     terminated after initial assessment of insufficient data to support clinical benefit in this~     population.~   "
265540|NCT00005969|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin in treating~     patients who have recurrent or refractory Hodgkin's disease.~   "
265541|NCT00005883|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Phenethyl isothiocyanate may be effective in preventing~     lung cancer in smokers.~      PURPOSE: Phase I trial of phenethyl isothiocyanate in preventing lung cancer in people who~     smoke.~   "
265542|NCT00005796|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Inserting a~     specific gene into a person's peripheral stem cells may improve the body's ability to fight~     cancer or make the cancer more sensitive to chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus gene~     therapy in treating patients who have CNS tumors.~   "
265543|NCT00005649|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel and capecitabine in treating~     women who have metastatic breast cancer.~   "
265544|NCT00004933|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known if homoharringtonine is more effective than~     hydroxyurea for chronic myelogenous leukemia that has not responded to interferon alfa.~      PURPOSE: Randomized phase III trial to compare the effectiveness of homoharringtonine with~     that of hydroxyurea in treating patients who have chronic myelogenous leukemia that has not~     responded to interferon alfa.~   "
265545|NCT00004923|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and irinotecan in treating~     patients who have advanced solid tumors.~   "
265546|NCT00004903|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral~     stem cell transplantation in treating patients who have multiple myeloma.~   "
265547|NCT00004878|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy used to kill cancer cells. Sometimes the transplanted cells can be~     rejected by the body's normal tissues. Donor lymphocytes that have been treated in the~     laboratory may prevent this from happening.~      PURPOSE: Randomized phase II trial to study the effectiveness of donor lymphocytes to prevent~     graft-versus-host disease in patients who are undergoing peripheral stem cell transplantation~     for chronic myeloid leukemia.~   "
265548|NCT00004872|"~     RATIONALE: Endostatin may stop the growth of solid tumors by stopping blood flow to the~     tumor.~      PURPOSE: Phase I trial to study the effectiveness of endostatin in treating patients who have~     advanced refractory solid tumors.~   "
265549|NCT00004858|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have recurrent acute lymphoblastic leukemia or non-Hodgkin's lymphoma.~   "
265550|NCT00004604|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing.~      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients~     who have metastatic cancer that has not responded to previous treatment.~   "
265551|NCT00004249|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Biological therapies, such as QS21, use different ways to stimulate the immune system and~     stop cancer cells from growing.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus QS21 in treating~     patients who have small cell lung cancer that has responded to initial therapy.~   "
265552|NCT00004174|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation in treating patients who have stage III or stage IV~     breast cancer.~   "
265553|NCT00003960|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Bone marrow transplantation may allow the doctor to give higher~     doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor~     bone marrow transplantation in treating patients who have hematologic cancer.~   "
265554|NCT00003953|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel followed by~     surgery in treating women who have stage II or stage III breast cancer.~   "
265557|NCT00081861|"~     Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or~     Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma.~   "
265558|NCT00003950|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Cyclosporine may relieve the diarrhea caused by irinotecan.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan and cyclosporine in treating~     patients who have metastatic, advanced, or locally recurrent colorectal cancer that has not~     responded to fluorouracil.~   "
265559|NCT00003914|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with~     advanced kidney cancer.~   "
265560|NCT00003887|"~     RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with~     cancer that has recurred following bone marrow or peripheral stem cell transplantation.~      PURPOSE: Phase II trial to study the effectiveness of donated white blood cells in treating~     patients who have relapsed cancer following transplantation of donated bone marrow or~     peripheral stem cells.~   "
265561|NCT00003835|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug may kill more tumor cells. It is not yet known~     which chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III~     trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan~     in treating patients who have undergone surgery for stage III colon cancer.~   "
265562|NCT00003819|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given with QS21 in~     treating patients who have progressive prostate cancer.~   "
265563|NCT00003783|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug and combining drugs in different~     ways may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who~     have very high risk acute lymphocytic leukemia.~   "
265564|NCT00003765|"~     Phase I trial to study the effectiveness of O6-benzylguanine and carmustine in treating~     children who have refractory CNS tumors. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may~     kill more tumor cells.~   "
265565|NCT00003619|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells. Isotretinoin may help~     cancer cells develop into normal white blood cells.~      PURPOSE: Phase I/II trial of topotecan, fludarabine, cytarabine, and filgrastim followed by~     peripheral stem cell transplantation or isotretinoin in treating patients who have acute~     myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic~     leukemia.~   "
265566|NCT00003544|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with~     metastatic colorectal cancer.~   "
265567|NCT00003434|"~     Rational: White blood cells that have been treated with carcinoembryonic antigen peptide-1~     may help the body build an immune response to and kill tumor cells that express CEA.~      Purpose: Phase II trial to study the effectiveness of white blood cells plus carcinoembryonic~     antigen peptide-1 in treating patients with stage I, stage II, or stage III pancreatic cancer~     that has been surgically removed.~   "
265568|NCT00003427|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating~     patients with previously treated metastatic gastrointestinal cancer that has not responded to~     previous treatment.~   "
265569|NCT00003407|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal~     cells from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination~     chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous~     leukemia.~   "
265570|NCT00003398|"~     RATIONALE: Bone marrow that has been treated to remove certain white blood cells may be able~     to replace immune cells that were destroyed by chemotherapy or radiation therapy, and may~     reduce the chance of developing graft-versus-host disease following bone marrow~     transplantation.~      PURPOSE: Phase IV trial to study the incidence of graft-versus-host disease in patients who~     have hematologic cancer and who are undergoing bone marrow transplantation from a donor.~   "
265571|NCT00003270|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Umbilical cord blood transplantation may allow doctors to give higher doses of~     chemotherapy or radiation therapy and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and~     umbilical cord blood transplantation in treating patients with hematologic cancer.~   "
265572|NCT00003144|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells~     from the bad side effects of chemotherapy.~      PURPOSE: Randomized phase I trial to study the effectiveness of amifostine in treating~     patients who are receiving chemotherapy for recurrent or refractory solid tumors.~   "
265573|NCT00003094|"~     RATIONALE: A diet rich in carotenoids may be an effective treatment for cervical dysplasia.~      PURPOSE: Randomized phase II trial to study the effectiveness of a carotenoid rich diet in~     treating patients with cervical dysplasia.~   "
265574|NCT00003081|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~     Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy, peripheral~     stem cell transplantation, and radiation therapy in treating patients with recurrent~     metastatic Ewing's sarcoma, peripheral primitive neuroectodermal tumor, or rhabdomyosarcoma.~   "
265576|NCT00002866|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of~     immune cells found in bone marrow or peripheral blood and may help a person 's immune system~     recover from the side effects of chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and epirubicin with and~     without G-CSF in treating women with metastatic breast cancer.~   "
265577|NCT00006475|"~     RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective~     treatment for leukemia.~      PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have~     chronic myelogenous leukemia in blast crisis.~   "
265578|NCT00006463|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.~      PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children~     who have refractory solid tumors.~   "
265579|NCT00006357|"~     RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective~     treatment for soft tissue sarcoma.~      PURPOSE: Phase I/II trial to study the effectiveness of STI571 in treating patients who have~     recurrent or refractory soft tissue sarcoma.~   "
265580|NCT00006216|"~     RATIONALE: Ganciclovir may ease some of the side effects of cancer treatment. Vaccines made~     from a person's modified malignant mesothelioma cells may make the cancer more sensitive to~     ganciclovir.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus ganciclovir in~     treating patients who have stage I, stage II, or stage III malignant mesothelioma.~   "
265581|NCT00006049|"~     RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep~     growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. It is not yet known whether combination chemotherapy is more effective with~     or without ZD 1839 for non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without ZD 1839 in treating patients who have stage III or stage IV non-small cell~     lung cancer.~   "
265582|NCT00006048|"~     RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep~     growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. It is not yet known whether chemotherapy is more effective with or without ZD~     1839 for non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without ZD 1839 in treating patients who have stage IIIB or stage IV non-small cell~     lung cancer.~   "
265583|NCT00005870|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether nitrocamptothecin is more effective~     than other chemotherapy for cancer of the pancreas.~      PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with~     that of other chemotherapy in treating patients who have recurrent or refractory cancer of~     the pancreas.~   "
265584|NCT00005849|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in~     treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.~   "
265585|NCT00005842|"~     Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who~     have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate~     tumor cells and either kill them or deliver tumor-killing substances to them without harming~     normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.~   "
265586|NCT00005832|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have~     locally advanced or metastatic pancreatic cancer.~   "
265587|NCT00002794|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in~     treating children with retinoblastoma.~   "
265588|NCT00002553|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Bone marrow transplantation may be able to replace immune cells that were destroyed by~     chemotherapy or radiation therapy used to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation using~     unrelated bone marrow donors in treating patients who have hematologic cancer.~   "
265589|NCT00002485|"~     RATIONALE: Taking part in a clinical trial may help children with cancer receive more~     effective treatment.~      PURPOSE: Determine why patients who are eligible for protocols made available through the~     Pediatric Oncology Group do not enroll in them, and develop strategies to increase enrollment~     on these clinical trials.~   "
265590|NCT00002466|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug or combining chemotherapy with~     radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's~     sarcoma, Wilms' tumor, or bone cancer.~   "
265591|NCT00002456|"~     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were~     destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make~     an immune response against normal tissues. Methotrexate and cyclosporine may prevent this~     from happening.~      PURPOSE: Phase III trial to study the effectiveness of treatment with methotrexate and~     cyclosporine after bone marrow transplantation to provide protection against acute~     graft-versus-host disease.~   "
268249|NCT00057473|"~     This clinical research study is being conducted to investigate the effectiveness of combining~     carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory~     solid tumors.~   "
265593|NCT00081809|"~     Primary Objectives:~        -  To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of~          selected patients with indolent lymphoma. The efficacy endpoints are:~        -  the rate of complete and partial responses~        -  the time to progression.~      Secondary Objectives:~        -  To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein~          peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive~          weeks, followed by HSPPC-96 administered once every two weeks.~        -  To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens.~        -  To assess approximately the composition of the tissue source of the autologous HSPPC-96~          for each patient.~        -  To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the~          expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of~          patients with indolent lymphoma.~   "
265594|NCT00005092|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by the chemotherapy or radiation therapy used to kill tumor cells. Sometimes the~     transplanted cells are rejected by the body's normal tissues. Transplanting donated cells~     that have been treated with psoralen may prevent this from happening.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and~     psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell~     transplantation for hematologic cancer.~   "
265595|NCT00005082|"~     RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability~     to detect the extent of newly diagnosed cancer.~      PURPOSE: Diagnostic study of magnetic resonance imaging to determining the extent of cancer~     in patients who have newly diagnosed glioma.~   "
265596|NCT00005023|"~     RATIONALE: Vaccines may make the body build an immune response to tumor cells.~     Colony-stimulating factors such as sargramostim increase the number of immune cells found in~     bone marrow or peripheral blood.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in~     treating patients who have stage III or stage IV cancer.~   "
265597|NCT00004870|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Gene therapy such as oblimersen may make tumor cells more sensitive~     to chemotherapy drugs. Combining irinotecan and oblimersen may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining oblimersen and irinotecan~     in treating patients who have metastatic or recurrent colorectal cancer.~   "
265598|NCT00004254|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of raltitrexed in treating patients who~     have malignant mesothelioma that cannot be surgically removed.~   "
265599|NCT00004013|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Paclitaxel may stop the growth of breast cancer by stopping blood flow to the tumor.~      PURPOSE: Phase II trial to compare the effectiveness of paclitaxel with or without~     trastuzumab following peripheral stem cell transplantation in treating patients who have~     refractory stage IV breast cancer.~   "
265600|NCT00003899|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of melphalan and thiotepa plus bone marrow~     or peripheral stem cell transplantation in treating patients who have recurrent or refractory~     solid tumors.~   "
265601|NCT00003880|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with gene therapy using SCH-58500 may kill~     more tumor cells.~      PURPOSE: Randomized phase II/III trial to determine the effectiveness of paclitaxel plus~     carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III~     ovarian or stage III primary peritoneal cancer with residual disease following surgery to~     remove the tumor.~   "
265602|NCT00003790|"~     RATIONALE: Diagnostic procedures may improve the ability to detect residual disease.~      PURPOSE: Clinical trial to detect the presence of residual disease in children who are~     receiving therapy for acute myeloid leukemia or myelodysplastic syndrome.~   "
265603|NCT00003735|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of topotecan in treating children who have~     relapsed acute leukemia, acute myeloid leukemia, or blast phase chronic myelogenous leukemia.~   "
265604|NCT00003715|"~     RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune~     response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer~     cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of melanoma vaccine with~     that of interferon alfa-2b in treating patients who have stage III melanoma that has spread~     to regional lymph nodes following surgery.~   "
265605|NCT00003701|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether four-drug combination chemotherapy is more effective than two-drug~     combination chemotherapy in treating bladder cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients who have bladder cancer.~   "
265606|NCT00003621|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have newly diagnosed anaplastic astrocytoma.~   "
265607|NCT00003445|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with~     advanced cancer of the cervix.~   "
265608|NCT00003386|"~     RATIONALE: Vaccines made from tumor tissue may make the body build an immune response and~     kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients~     who have stage III or stage IV ovarian epithelial cancer.~   "
265609|NCT00003148|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous~     leukemia cells.~      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with~     acute myelogenous leukemia that has relapsed following previous treatment.~   "
265610|NCT00003146|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     bone marrow or peripheral stem cell transplantation in treating patients with multiple~     myeloma.~   "
265611|NCT00003076|"~     RATIONALE: Chemoprevention therapy is the use of drugs to try and prevent the development or~     recurrence of cancer. It is not known whether eflornithine is effective in preventing cancer~     in patients with Barrett's esophagus.~      PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of eflornithine~     in preventing cancer in patients with Barrett's esophagus.~   "
265612|NCT00003041|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating women who~     have refractory metastatic breast cancer.~   "
265613|NCT00081848|"~     This study will evaluate the safety and effects of vaccine treatment plus radiation to the~     liver in patients with solid tumors that have spread to the liver. The vaccine treatment~     consists of three parts: 1) a priming vaccine called rV-CEA(6D)-TRICOM, made from vaccinia~     virus; 2) a boosting vaccine called rF-CEA(6D)-TRICOM), made from fowlpox virus; and 3) a~     fowlpox virus injected with DNA for GM-CSF, a chemical that boosts the immune system, called~     rF-GM-CSF. Human DNA is inserted into the priming and boosting vaccine viruses to cause~     production of proteins that enhance immune activity and also to produce carcinoembryonic~     antigen (CEA) - a protein that is normally produced by the patient's tumor cells. The study~     also uses radiation, because laboratory and animal studies show that low doses of radiation~     to tumors that produce CEA make the tumor more sensitive to the effects of the vaccines.~      Patients 18 years of age and older who have a solid tumor that has spread to the liver may be~     eligible for this study. Candidates must have had at least one course of chemotherapy for~     metastatic disease and their tumor must produce CEA. Candidates are screened with a medical~     history and physical examination; blood and urine tests, test of pathology slides from~     surgery to determine the presence of the CEA marker, imaging studies to assess the extent of~     tumor, and an electrocardiogram (and cardiologic evaluation, if clinically indicated).~      Participants receive the priming vaccination on study day 1. After 3 weeks and then again~     every 2 weeks for 2 months (study days 21, 35, 49 and 63), they receive a boosting vaccine.~     All vaccines are injected under the skin. With every vaccination they also receive an~     injection of rF-GM-CSF to increase the number of immune cells at the vaccination site. The~     day after each of the first four boosting vaccinations, patients undergo 4 consecutive days~     of radiation to the tumor in the liver (study days 22-25, 36-39, 50-53 and 64-67). Patients~     may continue treatment with monthly booster vaccinations (without further radiation therapy)~     as long as their cancer does not get worse and they do not develop serious treatment side~     effects.~      Patients are monitored for safety and treatment response with the following tests and~     procedures:~        -  Blood and urine tests and clinic visits every 2 to 4 weeks to monitor liver, kidney, and~          other organ function.~        -  Imaging studies to assess the tumor around study day 91 and every 2 months after that~          while on the study.~        -  Apheresis (a procedure for collecting immune cells called lymphocytes) - Apheresis is~          done before the first vaccination on study day 1 and again around study day 91. For this~          procedure, blood is collected through a needle in an arm vein. The blood circulates~          through a machine that separates it into its components by spinning, and the lymphocytes~          are extracted. The rest of the blood is returned to the patient through the same needle.~          The collected lymphocytes are studied to measure the immune response to treatment.~        -  Liver biopsy (optional) - This test is done once before starting radiation treatment and~          again around 3 to 7 days after completing the first dose of radiation. The biopsy~          provides information on the type of cancer, the level of CEA produced by the tumor, and~          the immune status of the tumor. For this procedure, the skin over the liver is numbed~          with an anesthetic, a needle is placed in the liver tumor, and a small sample of tumor~          is withdrawn through the needle.~      After treatment is completed, patients are monitored for up to 15 years, including yearly~     medical histories and physical examinations for 5 years following their last vaccination.~     Information beyond 5 years is collected once a year by telephone~   "
265614|NCT00081835|"~     This study will evaluate patients with eye complications related to vaccination against~     smallpox to learn more about these conditions. Vaccinia vaccination has been used for more~     than 100 years for preventing smallpox. A small number of people who receive the vaccination~     (less than 1 in 1,000) develop complications, sometimes in their eyes. This usually results~     from the accidental transfer of the infection from the vaccination site to the face or eyes,~     perhaps by touching the vaccination area and then the face or eyelids before washing the~     hands. The study will also examine whether an experimental treatment called NP-016 vaccinia~     immune globulin can reduce corneal scarring that is sometimes associated with serious~     vaccinia complications and can impair vision.~      Children and adults with keratitis, severe conjunctivitis, or blepharitis following exposure~     to vaccinia vaccination may be eligible for this study. Children must weigh at least 10 kg.~      Participants undergo the following tests and procedures at enrollment, with some tests~     repeated at scheduled study visits:~        1. Medical history and physical examination~        2. Infectious disease consultation~        3. Complete eye evaluation including:~             -  Fundus photography to examine the back of the eye - dilation of the pupils with eye~               drops to examine and photograph the back of the eye~             -  Slit lamp biomicroscopy - evaluation of the front part of the eye with a slit lamp~               microscope~             -  Eye pressure measurements~             -  Eye swab to look for vaccinia virus or other causes of disease~        4. Blood tests~        5. Photographs and documentation of eye and skin lesions~        6. Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine~          cultures; and tissue biopsies, if needed~      Patients begin treatment with standard medications for their eye disease, such as~     trifluridine (Viroptic® (Registered Trademark)) anti-viral eye drops. Patients whose~     condition becomes serious are offered additional treatment with intravenous (through a vein)~     infusions of either VIG or placebo (salt water solution with no active drug) and are randomly~     assigned to one or the other treatment group. All patients continue standard-of-care~     treatment as well.~      Follow-up visits at the NIH eye clinic are scheduled as required by the patient's condition.~     Patients with mild complications who are taking only standard medications may need to be seen~     only 1 month after the initial visit and then 6 months and 12 months later. Patients with~     more serious conditions who qualify for VIG or placebo treatments may be seen daily for a~     week, then once a week for the rest of the first month, and then at 6 months and 12 months,~     unless more frequent treatment or observation is required.~   "
265615|NCT00081796|"~     The purpose of this clinical trial is to determine if RPR109881 is a better treatment than~     capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from~     docetaxel and/or paclitaxel.~   "
265616|NCT00081783|"~     This is a Phase II single arm study of a novel T cell immunotherapy in patients with indolent~     non-Hodgkin’s lymphoma (NHL). Eligible patients will have relapsed or refractory disease~     after receiving at least one and no more than four prior regimens. Patients will receive~     Xcellerated T CellsTM, an ex vivo activated and expanded autologous T cell product, in an~     attempt to enhance immune responses with anti-tumor activity. The primary endpoint of the~     study is to evaluate the efficacy of Xcellerated T Cells in patients with indolent NHL.~     Secondary endpoints are to evaluate the safety of the therapy in this patient population, and~     to evaluate changes in the number and phenotype of T- and B-lymphocytes, as well as changes~     in the T cell receptor repertoire, hemoglobin levels, platelet counts and quantitative~     immunoglobulin levels. In a subset of patients, fine-needle aspirates of malignant lymph~     nodes will be performed to assess changes in the lymphocyte composition and phenotype. Bone~     marrow aspirates will be similarly evaluated. Finally, anti-tumor immune responses will be~     evaluated in patients amenable to biopsy of enlarged lymph nodes.~   "
265617|NCT00081770|"~     The objective is to compare the safety and efficacy of the following three treatment regimens~     in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1)~     PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2)~     PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3)~     PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.~   "
265618|NCT00081757|"~     The purpose of this study is to evaluate the use of thalidomide for the treatment of cancer.~     Patients with many types of cancers will be enrolled because the researchers will also study~     how the different cancers respond and what kind of side effects patients will experience.~   "
265619|NCT00021346|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and gemcitabine in~     treating patients who have advanced solid tumors.~   "
265620|NCT00019357|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.~     Combining white blood cells, which have been activated by a vaccine, with interleukin-2 may~     kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 plus activated white blood~     cells in treating patients with cancer that has not responded to chemotherapy or radiation~     therapy.~   "
265621|NCT00003018|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~     Chemotherapy following surgery may be an effective treatment for pancreatic cancer.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with stage II or stage III pancreatic cancer that has not been surgically removed.~   "
273945|NCT00005327|"~     To conduct a prospective study aimed at the early detection and treatment of cerebral~     vascular disease prior to irreversible brain injury in young children with sickle cell anemia~     (SCA).~   "
265622|NCT00003017|"~     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by~     stimulating a person's white blood cells to kill cancer cells in the cervix.~      PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients who~     have advanced or recurrent cancer of the cervix.~   "
265623|NCT00002952|"~     RATIONALE: Vaccines made from a tumor antigen gene may make the body build an immune response~     to kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor~     and by stimulating a person's white blood cell to kill melanoma cells. Combining vaccine~     therapy with interleukin-12 may kill more melanoma cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy plus interleukin-12~     in treating patients who have metastatic melanoma.~   "
265624|NCT00002889|"~     RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response~     of prostate tumors to therapy.~      PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been~     treated with radiation therapy plus androgen suppression therapy.~   "
265625|NCT00002818|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Deoxycytidine may protect patients from the side effects of~     high-dose cytarabine.~      PURPOSE: Phase I trial to study the effectiveness of high-dose cytarabine given with~     deoxycytidine in treating patients who have refractory acute myelogenous leukemia or other~     lymphoma or leukemia.~   "
265626|NCT00002800|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose cytarabine plus idarubicin in~     treating patients with newly diagnosed acute or chronic myelogenous leukemia or~     myelodysplastic syndrome.~   "
265627|NCT00002772|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give~     higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which~     regimen of chemotherapy followed by peripheral stem cell transplantation is more effective~     for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     plus peripheral stem cell transplantation in treating women who have undergone surgery for~     breast cancer.~   "
265628|NCT00002768|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation~     following chemotherapy in treating patients with acute myeloid leukemia in second remission.~   "
265629|NCT00002764|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether surgery plus combination chemotherapy is more effective than surgery alone~     in treating patients with lung metastases from soft tissue sarcoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination~     chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma~     that has spread to the lung.~   "
265630|NCT00002745|"~     Phase II trial to study the effectiveness of aminocamptothecin in treating patients who have~     refractory or recurrent Hodgkin's disease or non-Hodgkin's lymphoma. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die.~   "
265631|NCT00002722|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving higher doses may kill more~     tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of high-dose chemotherapy in~     treating patients with advanced stomach cancer.~   "
265632|NCT00002595|"~     RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using~     toremifene may fight the growth of desmoid tumors by reducing the production of estrogen.~      PURPOSE: Phase II trial to study the effectiveness of toremifene in treating patients with~     desmoid tumors.~   "
265633|NCT00002583|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if combination chemotherapy is more effective~     than no further treatment for non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine plus~     cisplatin with that of no further therapy in treating patients who have stage I or stage II~     non-small cell lung cancer that has been completely removed during surgery.~   "
265634|NCT00002534|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of bone marrow~     transplantation using untreated or treated bone marrow in treating patients with acute~     leukemia in first or second remission.~   "
265635|NCT00002519|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy with paclitaxel in~     combination with radiation therapy to the chest in patients with previously untreated stage~     III non-small cell lung cancer that cannot be surgically removed.~   "
265636|NCT00002501|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide and filgrastim in~     treating patients with stage IV, relapsed, or refractory low-grade follicular non-Hodgkin's~     lymphoma.~   "
265637|NCT00002492|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in~     treating patients who have soft tissue sarcoma.~   "
266019|NCT00003703|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy using sarCNU in patients~     who have advanced solid tumors.~   "
265638|NCT00002463|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of methotrexate, mechlorethamine,~     vincristine, procarbazine, and prednisone in treating children with astrocytomas or primitive~     neuroectodermal tumors.~   "
265639|NCT00081744|"~     Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate~     clinical situations.~   "
265640|NCT00081731|"~     This study will compare medical therapy plus stenting of hemodynamically significant renal~     artery stenoses versus medical therapy alone in patients with systolic hypertension and renal~     artery stenosis.~   "
265641|NCT00081705|"~     To measure the association between estrogen receptor variants and the extent of~     atherosclerosis in the thoracic and abdominal aorta and the right coronary artery in subjects~     in the PDAY study.~   "
265642|NCT00081692|"~     To relate cardiac structure and blood pressure (BP) elevation in adults to childhood BP and~     body size and composition.~   "
265643|NCT00081679|"~     To further characterize the nature of the association between socioeconomic status (SES),~     health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a~     sample of over 4,000 twin pairs.~   "
265644|NCT00081666|"~     To use a new statistical method, the Logical Analysis of Data (LAD), to predict cardiac~     surgery risk.~   "
265645|NCT00081653|"~     This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg~     or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed~     Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly,~     or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and~     calcium. The anticipated time of study treatment is 2+ years, and the target sample size is~     500+ individuals.~   "
265646|NCT00019344|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating patients who~     have refractory cancer.~   "
265647|NCT00019240|"~     RATIONALE: Herpesvirus is found in Kaposi's sarcoma lesions in most patients; it is therefore~     possible that the herpesvirus has a role in causing Kaposi's sarcoma. Cidofovir is an~     antiviral drug that acts against many types of herpesvirus, and may be an effective treatment~     for Kaposi's sarcoma.~      PURPOSE: Phase II trial to study the effectiveness of cidofovir in treating patients with~     Kaposi's sarcoma with or without HIV infection.~   "
265648|NCT00016900|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of PNU-93914 in treating patients who have~     locally advanced or metastatic cancer of the esophagus.~   "
265649|NCT00010010|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     exemestane plus goserelin may fight breast cancer by reducing the production of estrogen.~      PURPOSE: Phase II trial to study the effectiveness of exemestane and goserelin in treating~     premenopausal women who have metastatic breast cancer that has not responded to previous~     tamoxifen.~   "
265650|NCT00009828|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of paclitaxel combined with~     fluorouracil-uracil and leucovorin in treating patients who have solid tumors.~   "
265651|NCT00081614|"~     The primary purpose of the study is to assess the potential benefit of combining two targeted~     therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to~     determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic~     renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of~     response, and survival compared with Avastin alone. Since Avastin has been shown to be active~     in renal cancer, the goal will be to assess whether this activity can be enhanced with~     Erlotinib.~   "
265652|NCT00081549|"~     This study is a Phase I/II study. In Phase I of this study, the objective is to determine the~     maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®)~     in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase~     II, the primary objective is to evaluate survival after therapy with Aroplatin and~     gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or~     metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity~     of adverse events and determine the proportion of non-progressors and the progression-free~     interval.~   "
265653|NCT00081536|"~     This study is a Phase I/II study. In Phase I of this study, the objective is to determine the~     maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in~     subjects with unresectable, local recurrence or distant metastases of colorectal cancer~     refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to~     evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary~     objectives are to evaluate frequency and severity of adverse events.~   "
265654|NCT00012129|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of annamycin liposomal in treating~     patients who have locally advanced or metastatic breast cancer that has not responded to~     previous chemotherapy.~   "
265655|NCT00009815|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced solid tumors.~   "
265656|NCT00005989|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have~     recurrent or metastatic non-small cell lung cancer.~   "
265677|NCT00004178|"~     RATIONALE: Inserting a gene that has been created in the laboratory into a person's white~     blood cells may make the body build an immune response to kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who~     have cancer that has not responded to previous therapy.~   "
265657|NCT00005958|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with~     gemcitabine and docetaxel plus filgrastim in treating patients who have locally recurrent or~     advanced urothelium cancer.~   "
265658|NCT00005950|"~     Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent~     or refractory non-Hodgkin's lymphoma or T-cell lymphoma. Drugs used in chemotherapy use~     different ways to stop cancer cells from dividing so they stop growing or die~   "
265659|NCT00005938|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have~     biliary cancer.~   "
265660|NCT00005828|"~     RATIONALE: Green tea extract contains substances that may slow the growth of certain cancers~     and may prevent the development of new cancers.~      PURPOSE: Phase II trial to determine the effectiveness of green tea extract in treating~     patients who have metastatic prostate cancer that has not responded to hormone therapy.~   "
265661|NCT00005827|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase I trial to determine the effectiveness of genistein in treating~     patients who have stage II, stage III, or stage IV prostate cancer.~   "
265662|NCT00081640|"~     PRO 2000 Gel is designed to be inserted into the vagina to protect women from getting HIV~     during sex. So far, PRO 2000 Gel has been tested for safety in 136 women from Europe and the~     United States. This study will evaluate the safety and acceptability of PRO 2000 Gel when~     used by women in Pune, India. The study will also examine what Indian women and men think~     about using PRO 2000 Gel.~   "
265663|NCT00081601|"~     The purpose of this study is to determine the proportion of patients with a serological~     prostate specific antigen (PSA) by day 85.~   "
265664|NCT00081588|"~     The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of~     TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over~     time and to evaluate the immunological effect over time.~   "
265665|NCT00081575|"~     To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of~     subjects with CAP requiring hospitalization.~   "
265666|NCT00081562|"~     Ankylosing spondylitis (AS) is a chronic inflammatory disease that affects the joints between~     the vertebrae of the spine and the joints between the spine and the pelvis. The purpose of~     this study is to collect information and blood samples from patients with AS and their~     relatives for use in genetic studies.~   "
265667|NCT00081380|"~     The purpose of this study is to determine whether quetiapine when used as adjunct to lithium~     or divalproex is safe and effective in the maintenance treatment of adult patients with~     Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment~     Phase and the Randomized treatment Phase.~      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation~     was changed to XR after consultation with FDA.~   "
265668|NCT00005810|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     filgrastim in treating patients who have stage IV prostate cancer that has not responded to~     hormone therapy.~   "
265669|NCT00005809|"~     RATIONALE: New diagnostic procedures such as computed tomographic colonography may provide a~     less invasive method of identifying patients who have colorectal neoplasia.~      PURPOSE: Diagnostic study to compare the effectiveness of computerized tomographic~     colonography with that of standard diagnostic procedures in detecting colorectal neoplasia.~   "
265670|NCT00005643|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating~     patients who have advanced or recurrent sarcoma of the uterus.~   "
265671|NCT00005625|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients~     who have previously treated metastatic osteosarcoma.~   "
265672|NCT00005608|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in~     treating women who have metastatic breast cancer.~   "
265673|NCT00005080|"~     Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma~     that has not been treated previously or that has not responded to previous treatment. Drugs~     used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die~   "
265674|NCT00005071|"~     RATIONALE: Diagnostic procedures and treatment-planning systems may affect outcome in~     patients suspected of having lung cancer.~      PURPOSE: Randomized diagnostic trial to compare the effectiveness of two types of diagnostic~     and treatment-planning systems in patients who are suspected of having lung cancer.~   "
265675|NCT00004252|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. SU5416 may stop the growth of colorectal cancer by stopping blood~     flow to the tumor. It is not yet known whether chemotherapy is more effective with or without~     SU5416 in treating metastatic colorectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of leucovorin and~     fluorouracil with or without SU5416 in treating patients who have metastatic colorectal~     cancer.~   "
265676|NCT00004229|"~     Phase I trial to study the effectiveness of endostatin in treating patients who have advanced~     solid tumors. Endostatin may stop the growth of cancer by stopping blood flow to the tumor.~   "
273946|NCT00005326|"~     To continue studies on the two major neurological complications of sickle cell disease (SCD):~     namely, stroke and chronic encephalopathy.~   "
265678|NCT00081510|"~     Primary Objective(s):~        -  To compare the activity (progression-free survival [PFS]) of anastrozole in combination~          with lonafarnib to that of anastrozole in combination with placebo in subjects with~          hormone-sensitive ADVANCED breast cancer.~      Secondary Objective(s):~        -  To determine the effects of anastrozole in combination with lonafarnib on objective~          response, duration of response, overall survival, and safety in subjects with advanced~          breast cancer. To assess the exposure and pharmacokinetics of lonafarnib and anastrozole~          in the subject population.~   "
265679|NCT00081497|"~     People with Fabry Disease have an alteration in their genetic material (DNA) which causes a~     deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that~     helps to break down and removes certain types of fatty substances called glycolipids. These~     glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids~     build up in various tissues such as the liver, kidney, skin, and blood vessels because~     a-galactosidase A is not present, or is present in small quantities. The build up of~     glycolipid (globatriaosylceramide or GL-3) levels in these tissues in particular is thought~     to cause the clinical symptoms that are common to Fabry disease. This study analyzed the~     safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease that~     previously participated in the AGAL-008-00 (NCT0074984) study.~   "
265680|NCT00081484|"~     This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc)~     Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in~     chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin.~     The anticipated time on study treatment is 3-12 months and the target sample size is 100-500~     individuals.~   "
265681|NCT00081471|"~     This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of~     renal anemia in patients with chronic kidney disease who are not on dialysis and not~     receiving epoetin or any other erythropoietic substance. The anticipated time on study~     treatment is 1-2 years and the target sample size is 100-500 individuals.~   "
265682|NCT00004177|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell~     transplantation may be able to replace immune cells that were destroyed by therapy used to~     kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus~     peripheral stem cell transplantation in treating patients who have refractory or recurrent~     ovarian epithelial cancer.~   "
265683|NCT00004108|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have~     liver cancer.~   "
265684|NCT00004107|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver~     cancer-killing substances to them without harming normal cells. Peripheral stem cell~     transplantation may be able to replace immune cells that were destroyed by monoclonal~     antibody therapy used to kill cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody~     therapy plus peripheral stem cell transplantation in treating patients who have lymphoma or~     Waldenstrom's macroglobulinemia that has not responded to previous therapy.~   "
265685|NCT00004100|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which regimen of chemotherapy is more effective~     for non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of~     chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
265686|NCT00004087|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver~     tumor-killing substances to them without harming normal cells. Peripheral stem cell~     transplantation may be able to replace immune cells that were destroyed by monoclonal~     antibody therapy used to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus~     peripheral stem cell transplantation in treating patients who have metastatic or recurrent~     colorectal cancer or pancreatic cancer that has not responded to previous treatment.~   "
265687|NCT00081523|"~     This study is not a treatment protocol and no experimental treatments are involved. Study~     participants may be seen as needed for clinical, translational and basic research studies, or~     as medically indicated. Subjects will receive their general medical care outside the NIH and~     will be seen at our clinic or at CNHS with varying frequency. Subjects may be seen for~     multiple visits. Subjects may be asked to return for additional testing as needed. Clinical~     care for patients with sickle cell disease will be provided as appropriate through the Sickle~     Cell Clinic and the inpatient clinical center.~   "
265688|NCT00004086|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and either kill them or~     deliver cancer killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus~     combination chemotherapy and peripheral stem cell transplantation in treating patients who~     have recurrent or B-cell cancer.~   "
265689|NCT00004085|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver~     tumor-killing substances to them. Peripheral stem cell transplantation may be able to replace~     immune cells that were destroyed by radioimmunotherapy used to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody~     therapy plus peripheral stem cell transplantation in treating patients who have stage IV~     breast cancer.~   "
265690|NCT00004084|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody~     therapy in treating patients who have lymphoma or leukemia that has not responded to previous~     chemotherapy.~   "
265766|NCT00003692|"~     RATIONALE: Video-assisted surgery may be an effective treatment and have fewer side effects~     than conventional surgery in patients with non-small cell lung cancer.~      PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery in treating~     patients who have non-small cell lung cancer.~   "
265691|NCT00004048|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver~     tumor-killing substances to them without harming normal cells. Chemotherapy uses different~     ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell~     transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy~     or chemotherapy used to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radioimmunotherapy with or without~     doxorubicin plus peripheral stem cell transplantation in treating patients who have thyroid~     cancer.~   "
265692|NCT00004046|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have~     metastatic breast cancer that has not responded to previous therapy.~   "
265693|NCT00004045|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have~     metastatic prostate cancer that has not responded to hormone therapy.~   "
265694|NCT00004033|"~     RATIONALE: Patient abstract not available~      PURPOSE: Patient abstract not available~   "
265695|NCT00004016|"~     RATIONALE: Interferon gamma may interfere with the growth of cancer cells and may be an~     effective treatment for melanoma and solid tumors.~      PURPOSE: Phase I trial to study the effectiveness of interferon gamma in treating patients~     with recurrent or metastatic melanoma or other solid tumors.~   "
265696|NCT00004010|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~     Radiation therapy uses high-energy x-rays to damage cancer cells. Giving radiation therapy~     after chemotherapy may be an effective treatment for Hodgkin's disease.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation~     therapy in treating children who have previously untreated stage II, stage III, or stage IV~     Hodgkin's disease.~   "
265697|NCT00003954|"~     In this study donor bone marrow transplantation is divided into a two step process to try to~     significantly reduce the side effects of the procedure yet still provide patients with~     multiple myeloma the benefits of this procedure~   "
265698|NCT00081458|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability, and~     pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral~     nutrition (PN)-dependent short bowel syndrome (SBS).~   "
265699|NCT00003917|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if topotecan is more effective given by~     infusion or by mouth.~      PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by~     infusion with that of topotecan given by mouth in treating patients who have small cell lung~     cancer that has relapsed following previous therapy.~   "
265700|NCT00003870|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation~     may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy~     used to kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy,~     cyclophosphamide, and total-body irradiation followed by peripheral stem cell transplantation~     in treating patients who have advanced recurrent acute lymphocytic leukemia.~   "
265701|NCT00003834|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients with liver metastases from colorectal cancer.~   "
265702|NCT00003824|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. It is not yet known whether ciprofloxacin is more~     effective than cephalexin in preventing cancer recurrence in patients who are undergoing~     surgery to treat bladder cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that~     of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for~     bladder cancer.~   "
265703|NCT00003809|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. It is not yet~     known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin~     alone for metastatic or recurrent head and neck cancer.~      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin~     with or without monoclonal antibody in treating patients who have metastatic or recurrent~     head and neck cancer.~   "
265704|NCT00003719|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have stage IV or recurrent soft tissue sarcoma that has been previously treated with~     chemotherapy.~   "
265705|NCT00003718|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have advanced soft tissue sarcoma.~   "
265706|NCT00003717|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than once drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus estramustine in~     treating patients who have metastatic prostate cancer that has not responded to hormone~     therapy.~   "
265720|NCT00021151|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Compassionate use refers to~     providing a drug to a patient on humanitarian grounds before the drug has received official~     approval.~      PURPOSE: Compassionate use of Campath-1H in treating patients who have refractory~     prolymphocytic leukemia or chronic lymphocytic leukemia.~   "
265707|NCT00003674|"~     RATIONALE: Dalteparin may be effective in inhibiting the growth of blood vessels in tumors,~     decreasing the risk of metastatic cancer, preventing the formation of blood clots, and~     improving quality of life in treating patients with advanced cancer that has not responded to~     previous treatment. It is not yet known if standard therapy is more effective with or without~     dalteparin in treating advanced breast, lung, colorectal, and prostate cancer.~      PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of standard~     therapy with or without dalteparin in treating patients who have advanced breast, lung,~     colorectal, or prostate cancer that has not responded to previous chemotherapy or hormone~     therapy.~   "
265708|NCT00003493|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     liposomal doxorubicin, vincristine, and dexamethasone in treating patients with newly~     diagnosed or previously treated multiple myeloma.~   "
265709|NCT00003307|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may~     protect normal cells from the side effects of radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus amifostine in~     treating patients with primary prostate cancer.~   "
265710|NCT00003283|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to compare the effectiveness of octreotide alone or with prednisone~     in treating patients with metastatic or recurrent thymoma.~   "
265711|NCT00003235|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug with either standard radiation therapy or radiation therapy~     given at different times may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     consisting of paclitaxel and carboplatin, plus either standard radiation therapy or radiation~     therapy given at different times, in treating patients with stage III non-small cell lung~     cancer that cannot be surgically removed.~   "
265712|NCT00003209|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet~     known whether giving radiation therapy with chemotherapy after surgery is more effective than~     radiation therapy alone after surgery in treating cervical cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without chemotherapy after surgery in treating patients with stage IB or stage IIA cervical~     cancer.~   "
265713|NCT00003125|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Colony-stimulating factors such as sargramostim may increase the number of immune cells.~     Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining~     vaccine therapy, sargramostim, and interleukin-2 may kill more cancer cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy,~     sargramostim, and interleukin-2 in treating patients who have advanced tumors.~   "
265714|NCT00003080|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of sequential chemotherapy followed by~     peripheral stem cell transplantation in treating patients with persistent or platinum~     refractory stage III or stage IV ovarian cancer.~   "
265715|NCT00003061|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus~     radiation therapy in treating patients who have primary CNS lymphoma.~   "
265716|NCT00003032|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It~     is not yet known whether standard therapy is more effective than high dose chemotherapy for~     breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy~     plus peripheral stem cell transplantation with that of standard therapy in treating women~     with metastatic or recurrent breast cancer that has responded to previous chemotherapy.~   "
265717|NCT00003010|"~     RATIONALE: Marimastat may stop the growth of breast cancer by stopping blood flow to the~     tumor. It is not known whether chemotherapy is more effective with or without marimastat for~     breast cancer.~      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of marimastat~     with that of no further therapy in treating women who have metastatic breast cancer that is~     responding or stable after chemotherapy.~   "
265718|NCT00021398|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be~     removed during surgery.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy~     followed by surgery and combination chemotherapy in treating patients who have stage II or~     stage III rectal cancer.~   "
265719|NCT00021281|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. SU5416 may stop the growth of tumor cells by stopping blood flow to~     the tumor. It is not yet known whether combination chemotherapy will be more effective with~     or without SU5416 in treating metastatic colorectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without SU5416 in treating patients who have metastatic colorectal cancer.~   "
265721|NCT00021008|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ZD0473 in treating patients who have~     progressive or relapsed non-small cell lung cancer.~   "
265722|NCT00020774|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of SCH 66336 with or without~     gemcitabine followed by surgery with that of surgery alone in treating patients who have~     primary liver cancer.~   "
265723|NCT00019552|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have~     recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.~   "
265724|NCT00019474|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.~     Colony-stimulating factors such as filgrastim may increase the number of immune cells found~     in bone marrow or peripheral blood and may help a person recover from the side effects of~     chemotherapy. Combining chemotherapy with interferon alfa may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and interferon~     alfa followed by filgrastim in treating patients who have gastrointestinal tract cancer.~   "
265725|NCT00019318|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of depsipeptide in treating patients who~     have solid tumors for which no standard therapy exists.~   "
265726|NCT00019123|"~     RATIONALE: Thalidomide may kill cancer cells by stopping the growth of new blood vessels to~     the tumor.~      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients with~     HIV-associated Kaposi's sarcoma.~   "
265727|NCT00014391|"~     RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is~     not yet known if ribavirin is more effective with or without monoclonal antibody therapy in~     treating patients who develop RSV pneumonia following peripheral stem cell transplantation.~      PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with or without~     monoclonal antibody in treating patients who develop RSV pneumonia following peripheral stem~     cell transplantation.~   "
265728|NCT00012311|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give~     higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if~     chemotherapy followed by peripheral stem cell transplantation is more effective than~     chemotherapy alone in treating metastatic breast cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy~     plus peripheral stem cell transplantation with that of chemotherapy alone in treating women~     who have stage IV breast cancer.~   "
265729|NCT00010283|"~     RATIONALE: Beclomethasone may be an effective treatment for graft-versus-host disease.~      PURPOSE: Phase I/II trial to study the effectiveness of beclomethasone in treating patients~     who have graft-versus-host disease of the esophagus, stomach, small intestine, or colon.~   "
265730|NCT00007943|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who~     have advanced colorectal cancer.~   "
265731|NCT00006045|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them~     or deliver tumor-killing substances to them without harming normal cells. It is not yet known~     if chemotherapy is more effective with or without monoclonal antibody therapy for acute~     myelogenous leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without monoclonal antibody therapy in treating patients who have refractory or~     relapsed acute myelogenous leukemia.~   "
265732|NCT00005875|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have metastatic melanoma.~   "
265733|NCT00005874|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have locally advanced or metastatic soft tissue sarcomas.~   "
265734|NCT00005873|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have locally recurrent or metastatic breast cancer.~   "
265735|NCT00002708|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known whether giving radiation therapy during surgery is more effective than standard~     radiation therapy in treating brain metastases.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without radiosurgery in treating patients with brain metastases that cannot be removed during~     surgery.~   "
265736|NCT00081432|"~     This study uses functional magnetic resonance imaging (fMRI) and diffusion tensor imaging~     (DTI) to examine how the brain processes tasks involving language and emotion in normal~     volunteers and in patients with epilepsy. MRI is a diagnostic and research tool that uses a~     strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI~     scanner is a metal cylinder surrounded by a magnetic field. During the test, the subject lies~     on a table that can slide in and out of the cylinder. DTI involves taking pictures of the~     brain while the subject is at rest in order to learn about the structure of the brain.~     Information gained from this study will help scientists evaluate the organization of language~     and emotional functions in the brain.~      Normal volunteers and patients with temporal lobe epilepsy 18 years of age and older who are~     native English speakers and who will undergo surgery for uncontrolled seizures may be~     eligible for this study. Candidates are initially screened by telephone, then with physical~     and neurologic examinations and cognitive testing.~      The study has two parts, conducted 6 to 12 months apart. Each part consists of the same sets~     of tests described below, using fMRI and DTI. In patients with epilepsy, Part 1 is scheduled~     before surgery and Part 2 after surgery.~        -  fMRI: Subjects are asked to perform two types of tasks while they undergo fMRI. In one~          task, they are shown pictures of animals and tools and are asked to name them. In a~          second task, they are shown pictures that range in content from sexually explicit~          material, to human injury and surgical slides, to pleasant images of children and~          wildlife and are asked to decide whether they find the pictures pleasant, neutral, or~          unpleasant.~        -  DTI: Subjects relax and remain still in the MRI scanner for about 45 minutes.~        -  Neuropsychological testing: Subjects may be asked to complete questionnaires, take~          pen-and-paper or computerized tests, and perform motor tasks.~      Participants may be asked to repeat the MRI studies, but not the neuropsychological tests, up~     to four times to investigate different brain functions or to confirm findings.~   "
265737|NCT00081419|"~     This study will examine how the brain controls movement in people with Tourette syndrome and~     chronic tic disorder to determine if the timing of movement is important in whether someone~     feels in control of their movements. Although movements in tic disorders are often~     characterized as involuntary, some patients claim that these movements are made~     voluntarily, or they are unable to decide if they are voluntary or involuntary. Previous~     experiments have shown that when people are asked to look at a clock and report the time they~     first decide to make a movement they report times later than the first brain waves associated~     with movement appear. When they are asked to report the time they first initiate the~     movement, they report times before the muscles actually begin to move. This study may help~     determine how the sense of willing and initiating an action is altered in patients with~     Tourette syndrome and chronic tic disorder, and how people may feel more or less in control~     of their movements.~      Normal volunteers and patients with Tourette syndrome or chronic tic disorder between 18 and~     65 years of age may be eligible for this study. Control subjects must not have any~     neurological or psychological disorders, and patients with Tourette syndrome of chronic tic~     disorder must not have any other neurological disorders. Patients with attention deficit~     hyperactivity disorder (ADHD) may not enroll in this study.~      All participants will have a medical history, physical examination, and a test to determine~     their level of attention. Patients will be interviewed about their symptoms and complete~     psychiatric rating scales. In addition, all participants will undergo the following~     procedures:~      Electric shock~      Participants look at a clock on a computer screen, the hands of which revolves quickly. While~     looking at the clock, each participant will be given small, non-painful electric shocks and~     asked, according to the clock, to say when they received the shocks. The shocks are repeated~     40 times.~      Arm movement~      Participants are asked to lift their arms off a table repeatedly, at random times, while they~     look at the computer clock. This exercise is repeated 80 times. Of these 80, participants are~     asked 10 times consecutively to say the time they first had the desire to move their arm, and~     then 10 consecutively the time they first felt that they were moving their arm.~      Electroencephalography (EEG) and Electromyography (EMG)~      Participants undergo EEG and EMG durin...~   "
265738|NCT00081406|"~     The purpose of this study is to compare three treatments to determine which is most effective~     in reducing anxiety in children.~   "
265739|NCT00081367|"~     This study will determine the effectiveness of cognitive behavioral therapy (CBT) in~     preventing future suicide attempts in repeat suicide attempters.~   "
265740|NCT00081341|"~     This study investigates the effects of the glucocorticoid hormone cortisol on brain structure~     and function. Patients with Cushing's disease are studied before and after treatment. Brain~     imaging and neuropsychologic tests are used to study changes in the hippocampus and thinking~     and learning functions as well as mood during the period of elevated cortisol. At several~     intervals after treatment, these are reexamined to study the degree of reversibility of the~     abnormalities. The contribution of cortisol as well as testosterone and estrogen to~     dysfunction and recovery is studied. Since elevated cortisol and dysregulation of its~     secretory system occurs in a significant proportion of the aged and in Alzheimers Disease and~     Major Depressive Disorder, these studies will help advance knowledge of the role of cortisol~     in these conditions.~   "
265741|NCT00081328|"~     The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National~     Institutes of Health (NIH) has sponsored a consortium of investigators to conduct a clinical~     treatment trial, Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY).~      The primary objective of the TODAY trial is to compare the efficacy of three treatment arms~     on time to treatment failure based on glycemic control. The secondary aims are to:~        -  compare and evaluate the safety of the three treatment arms;~        -  compare the effects of the three treatments on the pathophysiology of type 2 diabetes~          (T2D) with regards to beta cell function and insulin resistance, body composition,~          nutrition, physical activity and aerobic fitness, cardiovascular risk factors,~          microvascular complications, quality of life, and psychological outcomes;~        -  evaluate the influence of individual and family behaviors on treatment response; and~        -  compare the relative cost effectiveness of the three treatment arms.~      The three treatment regimens are: (1) metformin alone, (2) metformin plus rosiglitazone, and~     (3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program~     (TLP). The study recruits patients over a three-year period and follows patients for a~     minimum of two years. Patients are randomized within two years of the diagnosis of T2D.~   "
265742|NCT00005872|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have recurrent non-small cell lung cancer.~   "
265743|NCT00005833|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have~     recurrent or advanced colorectal cancer.~   "
265744|NCT00005820|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating men who~     have stage IV prostate cancer that has not responded to hormone therapy.~   "
265745|NCT00005801|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem~     cell transplantation may be able to replace immune cells that were destroyed by radiation~     therapy used to kill tumor cells. Infusions of donor white blood cells may decrease the~     body's rejection of the transplanted peripheral stem cells.~      PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy, peripheral~     stem cell transplantation, and donor white blood cell infusions in treating older patients~     who have acute myeloid leukemia.~   "
265746|NCT00005077|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating patients who~     have advanced cancer plus liver dysfunction.~   "
265747|NCT00005066|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine and~     carmustine in treating patients who have recurrent, metastatic, or locally advanced soft~     tissue sarcoma.~   "
265748|NCT00005061|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have relapsed or refractory solid tumors.~   "
265749|NCT00005058|"~     RATIONALE: New imaging procedures, such as enhanced ultrasound may improve the ability to~     determine the extent of breast cancer.~      PURPOSE: Diagnostic study of enhanced ultrasound in women who have locally advanced primary~     breast cancer.~   "
265750|NCT00005040|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have relapsed or refractory non-Hodgkin's lymphoma.~   "
265751|NCT00004885|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether fluorouracil and leucovorin plus~     irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and~     leucovorin with or without irinotecan in treating patients who have metastatic colorectal~     cancer.~   "
265752|NCT00004860|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in~     treating elderly patients who have metastatic colorectal cancer.~   "
265753|NCT00004238|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in~     treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
265754|NCT00004166|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells~     from the side effects of chemotherapy.~      PURPOSE: Randomized phase III trial to study the effectiveness of amifostine in treating~     patients who have ovarian epithelial cancer and who are receiving chemotherapy.~   "
265755|NCT00004137|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~     Colony-stimulating factors such as filgrastim may increase the number of immune cells found~     in bone marrow or peripheral blood and may help a person's immune system recover from the~     side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     filgrastim in treating patients who have previously untreated extensive-stage small cell lung~     cancer.~   "
265756|NCT00004102|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Leucovorin~     may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the~     drug.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.~   "
265757|NCT00004082|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining docetaxel, carboplatin, and~     gemcitabine in treating patients who have previously untreated, newly diagnosed epithelial~     cancer.~   "
265758|NCT00004002|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have~     advanced solid tumors or lymphoma that have not responded to previous treatment.~   "
265759|NCT00003911|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic~     radiosurgery may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by~     stereotactic radiosurgery in treating patients who have brain metastases from malignant~     melanoma.~   "
265760|NCT00003840|"~     RATIONALE: DTGM fusion protein may be able to locate cancer cells and stop them from growing.~      PURPOSE: Phase I/II trial to study the effectiveness of DTGM fusion protein in treating~     patients who have recurrent or refractory acute myeloid leukemia.~   "
265761|NCT00081354|"~     Background:~      The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past~     two decades and is the most rapidly increasing cancer in the U.S.~      Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal epithelium~     to a specialized intestinal-type columnar mucosa, increases the risk of EAC by 30-125, and is~     considered a precursor lesion for EAC.~      Individuals diagnosed with BE are currently entered into endoscopic surveillance programs to~     look for dysplasia or EAC. However, only 5% of subjects diagnosed with EAC have a previous~     diagnosis of BE or have been part of a surveillance program, so alternative screening methods~     are needed.~      Objectives:~      The primary goal of this project is to identify a practical blood-based biomarker(s) that can~     be used as a screening test to determine who has BE and who does not.~      Secondary goals of the project are to characterize germ-line and tissue biomarkers associated~     with BE, and to compare biomarkers in non-BE patients with and without GERD.~      Tertiary goals are to explore associations between biomarkers in blood or tissue and~     progression from BE to dysplasia or EAC, and to assess the stability of proteomic patterns~     over time.~      Eligibility:~      This study will be conducted among patients in the Barrett's Esophagus Registry (currently~     with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda~     beginning in 1992, as well as a comparison group of approximately 600 matched non-BE patients~     endoscoped in the GI clinic at NNMC for other conditions.~      Design:~      Blood and tissue samples will be collected as well as questionnaire data on risk factors and~     medications as well as GERD.~      Data analyses will be based primarily on laboratory testing of newly collected esophageal~     biopsies, brush samples, and blood samples, but secondarily will also include use of archival~     tissue biopsy samples.~      Follow up of BE Registry patients will include standard periodic surveillance endoscopies,~     additional blood samples, and ascertainment of disease status (i.e., progression).~      To distinguish BE versus non BE-patients in this case-control study, we will:~      assess predictability of BE status from serum proteomic patterns;~      characterize esophageal biopsies and brush samples for selected DNA alterations, RNA~     expression, and proteomic profiles;~      genotype patients for selected polymorphisms potentially associated with BE;~      compare blood and tissue biomarkers in non-BE patients with and without GERD;~      explore the association of biomarkers with progression from BE to dysplasia or EAC;~      assess proteomic pattern stability over time in BE patients.~   "
265762|NCT00081315|"~     The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine~     on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with~     unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined~     modality therapy.~   "
265763|NCT00005943|"~     RATIONALE: Inserting the gene for interleukin-2 into a person's melanoma cells may make the~     body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who~     have metastatic melanoma.~   "
265764|NCT00003754|"~     RATIONALE: Thalidomide may kill tumor cells by stopping the growth of new blood vessels to~     the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining thalidomide with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and~     cyclophosphamide in treating children who have recurrent or refractory childhood cancers.~   "
265765|NCT00003710|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus mitomycin in treating~     patients who have advanced solid tumors that are persistent or recurrent.~   "
265767|NCT00003642|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug and combining radiation therapy with chemotherapy may kill~     more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy combined with~     fluorouracil and cisplatin in treating patients who have stage II or stage III bladder~     cancer, and who have undergone transurethral resection.~   "
265768|NCT00003446|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of trimetrexate glucuronate, fluorouracil,~     and leucovorin in treating patients with recurrent or metastatic colorectal cancer.~   "
265769|NCT00003376|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if four-drug combination chemotherapy is more effective than two-drug combination~     chemotherapy in treating advanced cancer of the urothelium.~      PURPOSE: Randomized phase III trial to compare the effectiveness of four-drug combination~     chemotherapy with that of two-drug combination chemotherapy in treating patients who have~     advanced cancer of the urothelium.~   "
265770|NCT00003316|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with~     recurrent or refractory cancer of the uterus.~   "
265771|NCT00003301|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients with~     recurrent malignant glioma.~   "
265772|NCT00003232|"~     RATIONALE: Some drugs used in chemotherapy can reduce the pain experienced by some people~     with cancer. Combining more than one drug may be more effective at reducing cancer pain. It~     is not known whether receiving combination chemotherapy with clodronate is more effective~     than receiving combination chemotherapy without clodronate for hormone refractory metastatic~     prostate cancer.~      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of~     combination chemotherapy using mitoxantrone plus prednisone with or without clodronate in~     treating pain in patients with hormone refractory metastatic prostate cancer.~   "
265773|NCT00081302|"~     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells~     from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Giving cetuximab together with combination chemotherapy and radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel,~     carboplatin, and radiation therapy works in treating patients with unresectable stage IIIA or~     stage IIIB non-small cell lung cancer.~   "
265774|NCT00081289|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery~     may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill~     any remaining tumor cells.~      PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant~     chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating~     patients who are undergoing surgical resection for locally advanced rectal cancer.~   "
265775|NCT00081276|"~     Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor~     cells from dividing so they stop growing or die. Combining more than one drug may kill more~     tumor cells. This phase II trial is studying how well giving 3-AP together with cisplatin~     works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial~     cancer or primary peritoneal cancer~   "
265776|NCT00081263|"~     This randomized phase II trial studies how well celecoxib works in treating patients with~     cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop~     into cervical cancer. Celecoxib may be effective in preventing the development of cervical~     cancer in patients who have cervical intraepithelial neoplasia.~   "
265777|NCT00081250|"~     RATIONALE: It is not yet known whether the supplement creatine is effective in increasing~     weight and improving appetite and quality of life in patients who have cancer.~      PURPOSE: This randomized phase III trial is studying how well creatine works in increasing~     weight and improving appetite and quality of life in patients with weight loss caused by~     cancer.~   "
265778|NCT00081237|"~     RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of OSI-7904L and~     oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer.~   "
265779|NCT00081224|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Celecoxib may also make tumor cells more sensitive~     to chemotherapy and radiation therapy. Giving celecoxib with capecitabine and radiation~     therapy before surgery may shrink the tumor so that it can be removed.~      PURPOSE: This phase II trial is studying how well giving neoadjuvant celecoxib together with~     capecitabine and pelvic irradiation works in treating patients with stage II or stage III~     adenocarcinoma (cancer) of the rectum.~   "
265780|NCT00081211|"~     Phase I trial to study the effectiveness of intratumoral (in the tumor) PV701 in treating~     patients who have advanced or recurrent unresectable squamous cell carcinoma (cancer) of the~     head and neck. Vaccines made from a specially-modified virus such as PV701 may make the body~     build an immune response to kill tumor cells while leaving normal cells undamaged. Injecting~     PV701 directly into the tumor may cause a stronger immune response and kill more tumor cells~   "
265781|NCT00081172|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or~     deliver radioactive tumor-killing substances to them without harming normal cells.~      PURPOSE: This phase II trial is studying how well radiolabeled monoclonal antibody works in~     treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of~     the prostate.~   "
265782|NCT00081159|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as~     goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from~     producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to~     stop tumor cells from dividing so they stop growing or die. Zoledronate may prevent bone loss~     and stop the growth of tumor cells in bone. Radioactive substances such as strontium-89 may~     relieve bone pain associated with prostate cancer. It is not yet known whether hormone~     (androgen) ablation therapy and chemotherapy combined with zoledronate is more effective with~     or without strontium-89 in treating prostate cancer and bone metastases.~      PURPOSE: This randomized phase II trial is studying giving hormone ablation therapy,~     doxorubicin, and zoledronate together with strontium-89 to see how well it works compared to~     hormone ablation therapy, doxorubicin, and zoledronate alone in treating patients with~     androgen-dependent prostate cancer and bone metastases.~   "
265783|NCT00081133|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to~     stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the~     growth of cancer cells by blocking the enzymes necessary for their growth. Combining arsenic~     trioxide with imatinib mesylate may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide~     when given with imatinib mesylate and to see how well they work in treating patients with~     accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia~     chromosome-positive acute lymphoblastic leukemia.~   "
265784|NCT00081107|"~     RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well epothilone D works in treating patients~     with stage IIIB or stage IV non-small cell lung cancer that has not responded to~     platinum-based chemotherapy.~   "
265785|NCT00081094|"~     RATIONALE: Imaging procedures, such as carbon-11 acetate positron emission tomography (PET)~     and fludeoxyglucose F 18 PET, may improve the ability to detect hepatocellular carcinoma~     (liver cancer) and allow doctors to plan the most effective treatment.~      PURPOSE: This clinical trial is studying how well carbon-11 acetate PET and fludeoxyglucose F~     18 PET work in detecting cancer in patients with liver cancer.~   "
265786|NCT00081068|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with~     Waldenstrom's macroglobulinemia.~   "
265787|NCT00081055|"~     RATIONALE: OTI-010 may be effective for graft-versus-host disease prophylaxis (prevention) in~     patients who are undergoing donor peripheral stem cell transplantation for hematologic~     malignancies (cancer of the blood or bone marrow).~      PURPOSE: This randomized phase II trial is studying how well OTI-010 works in preventing~     graft-versus-host disease in patients who are undergoing donor peripheral stem cell~     transplantation for hematologic cancer.~   "
265788|NCT00081042|"~     RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with~     inoperable (unresectable) locally recurrent or metastatic melanoma.~   "
265789|NCT00081029|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.~     Intensity-modulated radiation therapy delivers thin beams of radiation of different strengths~     directly to the tumor from many angles. This type of radiation therapy may reduce damage to~     the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality of life.~     It is not yet known whether intensity-modulated radiation therapy is more effective than~     conventional radiation therapy in preventing xerostomia and improving quality of life in~     patients who have throat cancer.~      PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to~     see how well it works compared to conventional radiation therapy in treating patients with~     oropharyngeal or hypopharyngeal cancer who are at risk of developing xerostomia caused by~     radiation therapy.~   "
265790|NCT00081003|"~     RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct~     endoscopy, may help doctors detect cancer cells early and plan more effective treatment for~     breast cancer.~      PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and~     breast duct endoscopy work in detecting cancer cells in healthy women who are at~     moderate-to-high risk of developing breast cancer.~   "
265791|NCT00080990|"~     This phase I trial is studying the side effects and best dose of alvocidib when given~     together with oxaliplatin, fluorouracil, and leucovorin calcium in treating patients with~     advanced solid tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin,~     fluorouracil, and leucovorin calcium, work in different ways to stop tumor cells from~     dividing so they stop growing or die. Alvocidib may also make tumor cells more sensitive to~     chemotherapy. Combining more than one chemotherapy drug may kill more tumor cells.~   "
265792|NCT00080977|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell~     carcinoma (kidney cancer) cells.~      PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works~     in treating patients with metastatic renal cell carcinoma that has not responded to previous~     low-dose intravenous or subcutaneous interleukin-2.~   "
265793|NCT00080951|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and~     oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy as first-line~     therapy in treating patients who have metastatic colorectal cancer.~   "
265831|NCT00002987|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor~     cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     plus radiation therapy with radiation therapy alone in treating patients with early-stage~     Hodgkin's disease.~   "
265794|NCT00080938|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     temozolomide may make the tumor cells more sensitive to radiation therapy. Combining~     temozolomide with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving temozolomide together with~     whole-brain radiation therapy works in treating patients with brain metastasis secondary to~     non-small cell lung cancer.~   "
265795|NCT00080925|"~     RATIONALE: Donor peripheral stem cell transplantation may be able to replace bone marrow and~     immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a~     donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells~     before transplanting them and giving cyclosporine may prevent this from happening.~      PURPOSE: This phase I trial is studying the side effects of T-cell-depleted allogeneic stem~     cell transplantation after immunoablative induction chemotherapy and reduced-intensity~     transplantation conditioning (chemotherapy) in treating patients with hematologic~     malignancies.~   "
265796|NCT00080912|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known whether single-fraction (single-dose) re-irradiation therapy is as effective as~     multiple-fraction (many small doses of radiation therapy) re-irradiation therapy in relieving~     bone pain caused by bone metastases.~      PURPOSE: This randomized phase III trial is studying single-dose radiation therapy to see if~     it works as well as multiple-dose radiation therapy in treating patients previously~     irradiated with painful bone metastases.~   "
265797|NCT00080899|"~     This phase II trial is studying how well fenretinide works in treating patients with~     biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy)~     prostate cancer. Drugs used in chemotherapy, such as fenretinide, work in different ways to~     stop tumor cells from dividing so they stop growing or die~   "
265798|NCT00080886|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different~     ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and~     combination chemotherapy with autologous stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination~     chemotherapy followed by autologous hematopoietic stem cell transplantation in treating~     patients who have B-cell non-Hodgkin's lymphoma.~   "
265799|NCT00080873|"~     RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the~     severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem~     cell transplantation.~      PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing~     or treating mucositis in young patients who are receiving chemotherapy with or without~     total-body irradiation before undergoing stem cell transplantation.~   "
265800|NCT00080860|"~     RATIONALE: Sentinel lymph node biopsy and gene expression profiling of the primary breast~     tumor may help determine if tumor cells have spread to the axillary lymph nodes and help~     doctors plan more effective surgery for breast cancer.~      PURPOSE: This clinical trial is studying how well sentinel lymph node biopsy and primary~     tumor gene expression profiling work in finding lymph node metastases in women who have~     received neoadjuvant therapy for stage II, stage III, or stage IV breast cancer.~   "
265801|NCT00080847|"~     This randomized phase II trial is studying rituximab and combination chemotherapy to see how~     well they work compared to oblimersen, rituximab, and combination chemotherapy in treating~     patients with advanced diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies,~     such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing~     substances to them without harming normal cells. Drugs used in chemotherapy, such as~     cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop~     cancer cells from dividing so they stop growing or die. Oblimersen may increase the~     effectiveness of anticancer drugs by making cancer cells more sensitive to the drugs.~     Combining rituximab and combination chemotherapy with oblimersen may kill more cancer cells~   "
265802|NCT00080834|"~     RATIONALE: Drugs used in chemotherapy, such as DJ-927, work in different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well DJ-927 works as second-line therapy in~     treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma~     (cancer).~   "
265803|NCT00080808|"~     RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard~     therapies for erectile dysfunction may be effective in helping patients with prostate cancer~     improve sexual satisfaction and quality of life. It is not yet known whether erectile~     dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve~     grafting.~      PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to~     see how well they work compared to standard therapy alone in treating erectile dysfunction in~     patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.~   "
265804|NCT00080795|"~     RATIONALE: Drugs used in chemotherapy, such as ifosfamide, doxorubicin, gemcitabine, and~     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug, and giving them before surgery, may shrink the tumor so~     that it can be removed.~      PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works~     in treating patients undergoing radical cystectomy for locally advanced carcinoma of the~     urothelium.~   "
265805|NCT00080782|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Strontium-89 may relieve bone pain~     caused by prostate cancer. Celecoxib may stop the growth of cancer by stopping blood flow to~     the tumor and by blocking the enzymes necessary for tumor cell growth. Combining doxorubicin~     and strontium-89 with celecoxib may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying celecoxib together with doxorubicin and~     strontium-89 to see how well they work compared to doxorubicin and strontium-89 alone in~     treating patients with progressive androgen-independent prostate cancer and bone metastases.~   "
266036|NCT00003021|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of bizelesin in treating patients who have~     advanced cancer.~   "
265806|NCT00080756|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and~     testosterone (given to replace hormones suppressed by deslorelin) may be effective in~     preventing breast cancer in at-risk women.~      PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol~     and testosterone works in preventing breast cancer in premenopausal women who are at high~     risk for this disease.~   "
265807|NCT00080743|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of~     estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing~     tumor cells that have become resistant (stopped responding) to tamoxifen.~      PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with~     tamoxifen works compared to gefitinib alone in treating patients with metastatic breast~     cancer that has stopped responding to tamoxifen.~   "
265808|NCT00080678|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth~     of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with~     imatinib mesylate may be effective treatment for androgen-independent prostate cancer and~     bone metastases.~      PURPOSE: This randomized phase II trial is studying docetaxel and imatinib mesylate to see~     how well they work compared to docetaxel alone in treating patients with androgen-independent~     prostate cancer and bone metastases.~   "
265809|NCT00080665|"~     RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor~     cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of~     tumor cells by blocking the enzymes necessary for their growth. Giving docetaxel with~     imatinib mesylate may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when~     given together with imatinib mesylate in treating patients with locally advanced or~     metastatic breast cancer.~   "
265810|NCT00080639|"~     RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of~     developing ovarian cancer may help doctors detect cancer early and plan more effective~     treatment.~      PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who~     are at high risk of developing ovarian cancer.~   "
265811|NCT00080626|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before~     surgery may shrink the tumor so that it can be removed.~      PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating~     women who are undergoing surgery for breast cancer.~   "
265812|NCT00080613|"~     RATIONALE: Estrogen and progesterone can stimulate the growth of breast cancer cells. Hormone~     therapy using exemestane may fight breast cancer by reducing the production of estrogen and~     progesterone. Giving hormone therapy before surgery may shrink the tumor so it can be removed~     with breast-conserving surgery. Giving hormone therapy after surgery may kill any remaining~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in~     treating postmenopausal women who have locally advancedestrogen and/or progesterone~     receptor-positive breast cancer.~   "
265813|NCT00080600|"~     OBJECTIVE: Many persons who survive poliomyelitis develop pain, weakness, and fatigue many~     decades later. It is not known why some persons develop this syndrome and others do not. One~     possibility is that polio caused subclinical damage to the motor cortex. Autopsies in some~     polio patients have found damage to the brainstem and motor cortex as well as to spinal motor~     neurons. Alternatively, polio may have spared the motor cortex, but the cortex reorganized in~     different ways to compensate for the loss of spinal motor neurons. This study will first~     assess the integrity of central motor pathways in polio survivors with and without postpolio~     syndrome. The second goal will be to investigate differences in the intracortical mechanisms~     for controlling muscles affected and unaffected by polio.~      STUDY POPULATION: 60 patients who survived polio in childhood. Only patients with an~     unequivocal history of polio will be referred to this study. Half of the patients will have~     the post-polio syndrome. 30 normal volunteers, aged 21-75.~      DESIGN: Patients will be screened at the collaborating institution, the Uniformed Services~     University of the Health Sciences, which will also perform sensory evoked potential testing~     and MRI. At NIH, motor evoked potentials will be elicited from all four limbs using~     transcranial magnetic stimulation to assess central motor conduction time and threshold.~     Intracortical facilitation will be used to assess using paired-pulse magnetic stimulation.~     Two muscles will be tested in each patient, one affected by polio and one unaffected by~     polio. In the affected muscle, intracortical facilitation will be assessed again after~     exercises it until it fatigues.~      OUTCOME PARAMETERS: Cortical thresholds and central motor conduction times to all four limbs~     will be measured in patients and compared to normal subjects. The mean intracortical~     facilitation at rest will be compared in affected and unaffected muscles in polio patients~     with and without post-polio syndrome.~   "
265814|NCT00080587|"~     This study will compare changes in atherosclerotic plaque in the coronary arteries (vessels~     on the surface of the heart that supply blood to the heart) with changes in the carotid~     arteries (vessels in the neck that supply blood to the brain) in patients enrolled in a~     Pfizer-sponsored treatment trial for coronary artery disease. Atherosclerosis is a buildup of~     fatty deposits (plaque) in arteries that can lead to blockage of the vessel, possibly~     resulting in heart attack or stroke. A major question in cardiovascular disease is how~     closely atherosclerotic changes in the coronary arteries correlate with changes in the~     carotid artery that occur with treatment. substudy of a Pfizer.~      Patients enrolled in the Pfizer trial comparing the effectiveness of the drug atorvastatin~     with a combination of atorvastatin and CETP inhibitor (a drug to increase HDL cholesterol~     levels) may be eligible for this substudy.~      Participants undergo magnetic resonance imaging (MRI) and ultrasound of the carotid arteries~     to measure the thickness of the vessels. The results are then compared with the coronary~     artery images obtained as part of the patient's evaluation for the Pfizer trial.~      MRI~      MRI scans use a powerful magnet with an advanced computer system and radio waves to produce~     accurate, detailed pictures of organs and tissues. During the scan the patient lies on a~     table in a narrow cylinder containing a magnetic field, wearing earplugs to muffle loud~     noises that occur with electrical switching of the magnetic fields. A medicine called~     gadolinium contrast may be injected into a vein during part of the scan to brighten the~     images. The scan takes about 30 to 90 minutes. An electrocardiogram (ECG) is done during the~     scan to monitor the heart's electrical activity. Patients who agree to undergo another MRI~     test are also imaged in a scanner that uses a stronger (3 Tesla) magnet.~      Ultrasound~      An echocardiogram (ultrasound of the heart) uses sound waves to image the carotid arteries. A~     gel is applied to the area of the neck to be imaged and a small handheld ultrasound probe is~     held against the neck to take the pictures.~      Participants return after 2 years for a second set of tests.~   "
265830|NCT00003012|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which combination chemotherapy regimen is more~     effective following surgery for breast cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy~     consisting of cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin in~     treating women who have early stage breast cancer.~   "
265864|NCT00006031|"~     RATIONALE: Biopsy is the removal of cells or tissue for examination under a microscope. It is~     not yet known which type of breast biopsy is more effective for diagnosing breast lesions.~      PURPOSE: Randomized diagnostic trial to compare the effectiveness of two different types of~     biopsy in patients who have breast lesions that cannot be felt upon examination.~   "
265815|NCT00080574|"~     This study will examine whether and how levothyroxine (Synthroid, a synthetic thyroid~     hormone) affects the way the body handles other drugs. If levothyroxine does affect the~     metabolism of other drugs, the dose of those medications may need to be increased to enhance~     their action or decreased to avoid adverse reactions.~      Patients 18 years of age and older with thyroid cancer who are participating in NIH protocol~     #77-DK-0096 and are receiving long-term suppression therapy with levothyroxine may be~     eligible for this study. This is not a study of thyroid cancer or of potential new drugs to~     treat it. Thyroid cancer patients are being studied because their treatment regimen provides~     an opportunity to study drug metabolism while patients are both on and off levothyroxine~     therapy.~      Participants come to the NIH Clinical Center on two occasions: once while they are regularly~     taking their levothyroxine, and once while they are off the medication in preparation for~     their radioactive iodide diagnostic scan for the procedures outlined below. The time interval~     between the two clinic visits depends on whether the first visit is while the patient is on~     or off medication. Participants are asked to fast overnight before each visit and to abstain~     from certain foods and beverages for 48 to 72 hours before the visit. At each visit, patients~     undergo the following procedures:~        -  Medication history, limited physical examination, and blood draw for laboratory tests,~          including a test to look for genes important in eliminating medications from the body.~        -  Insertion of a catheter (thin plastic tube) into an arm vein for collecting blood~          samples.~        -  Shave skin biopsy (optional) to explore how proteins in the skin that metabolize and~          transport drugs are affected by thyroid hormone. For this procedure, the skin is~          cleaned, numbed with medicine, and a small sample of the top layer is removed with a~          razor blade. The wound heals in 2 to 3 days.~        -  Medication dosing. Participants take all of the following substances by mouth at the~          same time: 1) 200 mg of caffeine, a compound commonly found in chocolate, soda/pop,~          coffee, tea and non-prescription products to prevent sleep; 2) 30 mg of~          dextromethorphan, a non-prescription cough suppressant; 3) 40 mg of omeprazole, a~          prescription drug for heartburn and stomach ulcers; 4) 8 mg of midazolam, a prescription~          drug used to cause relaxation and drowsiness; and 5) 120 mg of fexofenadine, a~          non-sedating prescription antihistamine used to treat allergies.~        -  Blood and urine sampling. Fifteen blood samples of about 5 mL (1 teaspoon) each are~          collected through the catheter and urine is collected over the next 24 hours to~          determine what happens to the test drugs in the body.~      Participants may resume their normal diet 4 hours after taking the study medications.~   "
265816|NCT00080548|"~     This study will examine and compare how the brain controls the timing of movement in healthy~     volunteers and in people with schizophrenia. Previous experiments have shown that when people~     are asked to look at a clock and report the time they first decide to make a movement, they~     report times later than the first brain waves associated with movement appear. When they are~     asked to report the time they first initiate the movement, they report times before the~     muscles actually begin to move. The study may help determine how the sense of willing and~     initiating an action is altered in schizophrenic patients, and how people may feel more or~     less in control of their movements.~      Normal volunteers and patients with schizophrenia between 18 and 65 years of age may be~     eligible for this study. Control subjects must not have any neurological or psychological~     disorders, and schizophrenia patients must not have any other neurological disorders.~      All participants will have a medical history, physical examination, and a test to determine~     their level of attention. Schizophrenia patients will be interviewed about their symptoms and~     complete psychiatric rating scales. In addition, all participants will undergo the following~     procedures:~      Electric shock~      Participants look at a clock on a computer screen whose hands revolves around the clock fast.~     While they look at the clock, they are given small, non-painful electric shocks and are asked~     to say when they receive the shocks, according to the clock. The shocks are repeated 40~     times.~      Arm movement~      Participants are asked to lift their arm up off a table repeatedly, at random times, while~     they look at the computer clock. This exercise is repeated a total of 80 times. Of these 80~     times, participants are asked 10 times in a row to say the time they first had the desire to~     move their arm, and then 10 times in a row the time they first felt that they were moving~     their arm.~      Electroencephalography (EEG) and Electromyography (EMG)~      Participants undergo EEG and EMG during the electric shock and arm movement experiments to~     measure electrical activity of the brain (EEG) and of the muscles (EMG). For EEG, electrodes~     (small metal discs) are placed on the scalp with a cap, paste, or glue-like substance and the~     brain waves are recorded. For EMG, electrodes are taped to the skin over the muscle.~   "
265817|NCT00080535|"~     This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating~     cutaneous T-cell lymphoma in patients who have a protein called cluster of differentiation 25~     (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. It is made up of two parts:~     a genetically engineered monoclonal antibody that binds to CD25, and a toxin produced by~     bacteria that kills the cancer cells to which it binds. LMB-2 has killed CD25-containing~     cells in laboratory experiments and has caused tumors in mice to shrink. Preliminary studies~     in humans have shown some effectiveness in shrinking tumors in patients with various types of~     lymph and blood cancers.~      Patients 18 years of age and older with stage 1b to IV cutaneous T-cell lymphoma that has~     progressed within 2 years of systemic or topical therapy and who have CD25 receptor proteins~     on their cancer cells may be eligible for this study. Candidates are screened with a medical~     history and physical examination, blood and urine tests, electrocardiogram (EKG),~     echocardiogram, chest x-ray, computed tomography (CT) scans of the chest, abdomen and pelvis,~     skin punch biopsy to evaluate tumor infiltration in the skin, and a bone marrow biopsy on~     patients with stage IIa disease and higher. In addition, the patient's blood, bone marrow,~     tumor, or other tissue is tested to determine the presence of CD25 on cancer cells.~      Participants receive up to nine cycles of LMB-2 therapy as long as their cancer does not~     worsen and they do not develop serious side effects. Each 28-day cycle consists of 30-minute~     infusions of LMB-2 on cycle days 1, 3, and 5. The drug is infused through an intravenous (IV)~     catheter (plastic tube placed in a vein) or a central venous line - an IV tube placed in a~     large vein in the neck or chest that leads to the heart. In addition to drug therapy,~     patients undergo the following procedures:~      Blood draws: Blood is drawn before, during, and after each LMB-2 infusion to measure blood~     levels of the drug, evaluate its effects on the cancer cells, and monitor side effects. Blood~     tests are also done before and during each cycle to determine how the immune system is~     interacting with the drug.~      Disease evaluations: Patients undergo a careful skin examination, blood tests, chest x-ray,~     and EKG before each treatment cycle and at follow-up visits. A CT scan and echocardiogram~     (heart ultrasound) are done before the first cycle. Before the first and second cycles,~     patients have a biopsy of the lymphoma on the skin. If the biopsy is helpful in evaluating~     the disease response to LMB-2, additional biopsies may be requested prior to other cycles as~     well. A nuclear medicine scan may be done, and a bone marrow biopsy may be done in patients~     with stage II to IV disease. If these tests are helpful in understanding the response of the~     lymphoma to treatment, they may also be repeated prior to other cycles, with the patient's~     permission.~      Patients are admitted to the National Institutes of Health (NIH) Clinical Center for the~     first treatment cycle. Subsequent cycles are given as outpatients. If the infusions are well~     tolerated, patients may return home after about one week (or possibly longer if complications~     occur). After returning home, patients have blood tests done weekly by their local~     physicians.~   "
265818|NCT00080522|"~     Providing effective anti-HIV therapy in developing countries is challenging. This study will~     evaluate new strategies for delivering anti-HIV medications to people in South Africa. These~     strategies include using specially trained nurses to administer therapy (rather than~     doctors), treating all HIV infected members of a household at the same time, and having~     community members observe patients taking their medications.~   "
265819|NCT00080509|"~     The purpose of this study is to determine whether a potential drug known as KOS-862 or~     Epothilone D has an effect as a 2nd line treatment in non-small cell lung cancer (NSCLC)~     for patients having failed one prior platinum-containing chemotherapy regimen.~   "
265820|NCT00080496|"~     To compare the efficacy and safety of the tigecycline regimen with that of the~     imipenem/cilastatin regimen in subjects with nosocomial pneumonia.~   "
265821|NCT00003176|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide and carmustine in treating~     patients with anaplastic glioma.~   "
265822|NCT00003156|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with~     recurrent or refractory cancer of the uterus.~   "
265823|NCT00003132|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus cisplatin in treating~     patients who have metastatic or unresectable cancer.~   "
265824|NCT00003110|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bleomycin in treating patients with~     non-Hodgkin's lymphoma.~   "
265825|NCT00002997|"~     RATIONALE: Cryosurgery for liver metastases may have fewer side effects and improve recovery.~      PURPOSE: Phase II trial to study the effectiveness of cryosurgery for patients with~     unresectable liver metastases from colorectal cancer.~   "
265826|NCT00080483|"~     Deficiency of testosterone, growth hormone, or both hormones can result in osteoporosis. If~     either hormone is replaced, the condition of the bones improves. The purpose of this study is~     to determine if dual hormone treatment for men deficient in testosterone and growth hormone~     improves bone structure more than testosterone treatment alone.~   "
265827|NCT00024063|"~     RATIONALE: Drugs such as SU006668 may stop the growth of solid tumors by stopping blood flow~     to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of SU006668 in treating patients who have~     advanced solid tumors.~   "
265828|NCT00003107|"~     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by~     stimulating a person's white blood cells to kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients who~     have hematologic cancer or solid tumor.~   "
265829|NCT00003103|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of oblimersen in treating patients who~     have solid tumors that have not responded to previous therapy.~   "
266284|NCT00077688|"~     Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel~     in taxane-naive patients receiving second line chemotherapy for metastatic or locally~     advanced, unresectable transitional cell carcinoma of the urothelium~   "
265832|NCT00002814|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using~     paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or~     anaplastic astrocytoma that is refractory or recurrent.~   "
265833|NCT00002774|"~     PURPOSE: Randomized phase 2 trial to compare the effectiveness of chemo-radiation therapy (RT~     + cisplatin + 5-FU) with or without tirapazamine for the treatment of patients with stage III~     or IV squamous cell carcinomas of the head and neck cancer (SCCHN).~      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation~     therapy uses high-energy x-rays to damage tumor cells.~      Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making~     tumor cells more sensitive to therapy.~   "
265834|NCT00002714|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have early stage Hodgkin's disease.~   "
265835|NCT00002600|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Bone marrow transplantation and peripheral stem cell~     transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with~     carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell~     transplantation in treating patients who have advanced ovarian epithelial cancer.~   "
265836|NCT00002525|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving drugs in different ways may~     kill more tumor cells. It is not yet known if surgery is more effective with or without~     chemotherapy for colon cancer.~      PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU)~     chemotherapy after curative resection could improve overall survival and disease-free~     survival in patients with Duke's B3 or C colon cancer.~   "
265837|NCT00002494|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and~     alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or~     acute lymphocytic leukemia.~   "
265838|NCT00080470|"~     This clinical trial is being conducted to investigate the safety and effectiveness of a new~     device designed to treat urinary urge incontinence in those patients who have tried and~     failed two or more conservative therapies.~   "
265839|NCT00080457|"~     The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan~     sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial~     hypertension (PAH).~   "
265840|NCT00023816|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of carbendazim in treating patients who~     have advanced solid tumors or lymphoma.~   "
265841|NCT00022386|"~     RATIONALE: Epoetin alfa may stimulate red blood cell production to treat patients who have~     anemia following chemotherapy.~      PURPOSE: Phase IV trial to study the effectiveness of epoetin alfa in treating~     chemotherapy-related anemia in women who have stage I, stage II, or stage III breast cancer.~   "
265842|NCT00022256|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     motexafin gadolinium may make tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of motexafin gadolinium plus radiation~     therapy to the brain in treating patients who have newly diagnosed glioblastoma multiforme.~   "
265843|NCT00020605|"~     RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid~     pain medications such as morphine.~      PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption~     in patients who are receiving opioids for chronic pain.~   "
265844|NCT00020540|"~     RATIONALE: Biological therapies such as flt3L and CD40-ligand use different ways to stimulate~     the immune system and stop cancer cells from growing. Biological therapy may be an effective~     treatment for metastatic melanoma and metastatic kidney cancer.~      PURPOSE: Phase I trial to study the effectiveness of flt3L combined with CD40-ligand in~     treating patients who have metastatic melanoma or metastatic kidney cancer.~   "
265845|NCT00019071|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of cladribine followed by radiation therapy~     in treating patients who have malignant glioma.~   "
265846|NCT00019058|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     pentoxifylline and hydroxyurea may make tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus pentoxifylline~     and hydroxyurea in treating patients who have high-grade astrocytoma or glioblastoma.~   "
265847|NCT00016042|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Biological therapies use different ways to stimulate the immune~     system and stop cancer cells from growing. Combining chemotherapy with biological therapy may~     kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of fluorouracil combined with biological~     therapy in treating patients who have metastatic kidney or colorectal cancer.~   "
265879|NCT00004097|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have advanced and/or recurrent head and neck cancer.~   "
265848|NCT00014573|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells. Vaccines made from a person's white blood cells and tumor cells may make the~     body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's~     white blood cells to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine~     therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in~     treating patients who have recurrent or refractory brain cancer.~   "
265849|NCT00080444|"~     This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and~     vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants~     treated with emetogenic cancer chemotherapies that include either cisplatin,~     cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when~     treated with a previously administered chemotherapy regimen that is planned to be repeated~     will be enrolled in this study. In the double-blind Part 1 of this study, enrolled~     participants will be randomized to receive either aprepitant or standard therapy. In Part 2~     of this study, enrolled participants will receive open-label aprepitant.~   "
265850|NCT00080418|"~     The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel~     Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion~     to patients with advanced cancer.~   "
265851|NCT00080405|"~     The purpose of this study is to characterize the clinical pharmacokinetic and pharmacodynamic~     profiles of the 2 doses of VELCADE (bortezomib) for Injection. Patients who volunteer to~     participate in the pharmacogenetic portion of the study, an additional blood sample will be~     collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug~     metabolizing enzymes.~   "
265852|NCT00009841|"~     RATIONALE: Gene therapy may kill cancer cells by inhibiting a gene that promotes the~     development and growth of cancer.~      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who~     have advanced head and neck cancer.~   "
265853|NCT00007813|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy used to kill tumor cells. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy~     with peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy drugs and kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide~     when given together with combination chemotherapy and a peripheral stem cell transplant in~     treating patients with malignant solid tumors.~   "
265854|NCT00006487|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have limited-stage small cell lung cancer.~   "
265855|NCT00006458|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy~     in treating patients who have relapsed or refractory non-small cell lung cancer.~   "
265856|NCT00006376|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have~     advanced bladder cancer.~   "
265857|NCT00006371|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as~     aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones.~     Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective~     treatment for prostate cancer.~      PURPOSE: Phase II trial to study the effectiveness of combining hydrocortisone with either~     aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate~     cancer.~   "
265858|NCT00006370|"~     RATIONALE: Radiolabeled drugs such as yttrium Y 90-DOTA-tyr3-octreotide can locate tumor~     cells and either kill them or deliver tumor-killing substances to them without harming normal~     cells.~      PURPOSE: Phase II trial to study the effectiveness of yttrium Y 90-DOTA-tyr3-octreotide in~     treating patients who have refractory small cell lung cancer or metastatic breast cancer.~   "
265859|NCT00006369|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     ERA-923 may fight breast cancer by blocking the uptake of estrogen by the tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of ERA-923 in treating~     postmenopausal women who have metastatic breast cancer that no longer responds to tamoxifen.~   "
265860|NCT00006368|"~     RATIONALE: Radiolabeled drugs such as yttrium Y 90 SMT 487 can locate tumor cells and deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 SMT 487 in treating~     patients who have refractory or recurrent cancer.~   "
265861|NCT00006052|"~     RATIONALE: STI571 may interfere with the growth of cancer cells and may be effective~     treatment for chronic myelogenous leukemia.~      PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have~     accelerated phase chronic myelogenous leukemia.~   "
265862|NCT00006043|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have metastatic germ cell tumors that have not responded to cisplatin.~   "
265863|NCT00006032|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     autologous peripheral stem cell transplantation in treating women who have metastatic breast~     cancer.~   "
265947|NCT00005816|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have stage III or stage IV kidney cancer.~   "
265865|NCT00005948|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies use different ways to stimulate the immune~     system and stop cancer cells from growing. Peripheral stem cell transplantation may be able~     to replace immune cells that were destroyed by chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral~     stem cell transplantation and biological therapy in treating patients who have chronic~     myelogenous leukemia.~   "
265866|NCT00005860|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin with or without floxuridine~     and leucovorin in treating patients who have metastatic cancer of the peritoneum.~   "
265867|NCT00005799|"~     This clinical trial studies fludarabine phosphate, low-dose total body irradiation, and donor~     stem cell transplant in treating patients with hematologic malignancies or kidney cancer.~     Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a~     donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may~     also stop the patient's immune system from rejecting the donor's stem cells. The donated stem~     cells may replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte~     infusion) after the transplant may help increase this effect. Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     cyclosporine before the transplant and cyclosporine and mycophenolate mofetil after the~     transplant may stop this from happening.~   "
265868|NCT00005798|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation in treating women who have breast cancer.~   "
265869|NCT00005628|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients~     who have recurrent soft tissue sarcoma.~   "
265870|NCT00005618|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have relapsed or refractory chronic myelogenous leukemia.~   "
265871|NCT00005615|"~     RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Radiation therapy~     uses high-energy x-rays to damage tumor cells. Combining interferon alfa plus radiation~     therapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa plus radiation~     therapy in treating patients who have stage III or recurrent melanoma that has been removed~     by surgery.~   "
265872|NCT00005577|"~     Phase I trial to study the effectiveness of gemcitabine in treating children who have~     refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die.~   "
265873|NCT00005097|"~     RATIONALE: Green tea extract contains ingredients that may inhibit the growth of actinic~     keratosis.~      PURPOSE: Randomized phase II trial to determine the effectiveness of green tea extract in~     treating patients who have actinic keratosis.~   "
265874|NCT00005068|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to determine the effectiveness of two different regimens of~     combination chemotherapy in treating patients who have metastatic or unresectable solid~     tumors.~   "
265875|NCT00003864|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating~     patients who have advanced cancer of the esophagus.~   "
265876|NCT00080431|"~     This study will examine the safety and effectiveness of daclizumab (also called Zenapax or~     anti-CD25) in reducing viral replication in patients with HIV infection. Although HAART, an~     intensive anti-HIV treatment regimen, can suppress HIV in blood below the limit of detection,~     it cannot completely eradicate the virus. This study will focus on the effectiveness of~     daclizumab in further reducing viral replication in patients with low viral counts. The Food~     and Drug Administration approved daclizumab in 1997 for preventing kidney transplant~     rejection, and it has also been studied in people with an eye infection called uveitis. The~     drug works by binding to a protein on T cells (white blood cells of the immune system) called~     CD25. This prevents another protein, called interleukin-2 (IL-2), from binding to this site,~     thus preventing a series of events that normally results in inflammation.~      Patients between 18 and 65 years of age with HIV infection who have stable HIV levels at less~     than 30,000 copies/mL of blood and CD4 T cell counts higher than 400 cells/cmm may be~     eligible for this study. Patients who have taken drugs that affect the immune system, such as~     IL-2 and interferon, in the past 5 years may not participate. Candidates are screened with a~     comprehensive medical examination, including physical examination and laboratory studies.~     X-rays, consultations, and biopsies are done only if medically indicated.~      Participants will undergo the following tests and procedures:~        -  Daclizumab therapy: Patients receive daclizumab as a 25-minute infusion through an~          intravenous catheter (plastic tube placed in a vein) at the NIH Clinical Center~          outpatient clinic. A total of three doses of drug are given. The first dose is given on~          study day 1, the second dose is given 2 weeks later, and the third dose is given 4 weeks~          later. Patients are observed for at least 1 hour after each infusion before being~          discharged from the clinic.~        -  Follow-up visits: Patients return to the outpatient clinic every 2 weeks while they are~          on medication and then every month until 3 months after the final dose to evaluate their~          infection status, response to therapy, and medication side effects. The visits include a~          physical examination, blood draws, and possibly x-rays, if medically indicated.~        -  Apheresis: Patients undergo apheresis, a procedure for collecting large amounts of white~          blood cells, three times during the study - once before starting daclizumab therapy, 4~          weeks after beginning therapy, and 12 weeks after beginning therapy. For apheresis,~          blood is removed through a needle in the vein of one arm and spun in a machine that~          separates it into its components. The white blood cells and plasma are removed, and the~          red cells and platelets are re-infused either through the same needle or through a~          needle in a vein in the other arm.~   "
265877|NCT00005031|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have~     persistent or recurrent refractory endometrial cancer.~   "
265878|NCT00004248|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill~     liver cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of doxorubicin and interleukin- 2 in~     treating patients who have liver cancer that cannot be removed by surgery.~   "
265880|NCT00003967|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of topotecan plus etoposide in treating~     patients who have recurrent ovarian cancer, peritoneal cancer, or fallopian tube cancer.~   "
265881|NCT00003883|"~     RATIONALE: Giving itraconazole or fluconazole may be effective in preventing infections in~     patients undergoing peripheral stem cell or bone marrow transplantation. It is not yet known~     whether itraconazole is more effective than fluconazole for preventing infections.~      PURPOSE: Randomized phase III trial to compare the effectiveness of itraconazole with~     fluconazole to prevent infections in patients undergoing peripheral stem cell or bone marrow~     transplantation.~   "
265882|NCT00003769|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it~     can be removed during surgery.~      PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol followed by surgery in~     treating patients who have stage II or stage III pancreatic cancer.~   "
265883|NCT00003657|"~     The purpose of the study is to evaluate the combination of amifostine and high dose~     chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal~     tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side~     effects of chemotherapy given at conventional doses.~   "
265884|NCT00003635|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients with~     chronic lymphocytic leukemia that has not responded to fludarabine or alkylating agents.~   "
265885|NCT00003412|"~     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by~     stimulating a person's white blood cells to kill breast cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating women with~     metastatic breast cancer who have received high-dose chemotherapy and peripheral stem cell~     transplantation.~   "
265886|NCT00003402|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation~     plus combination chemotherapy in treating patients who have low-grade non-Hodgkin's lymphoma~     or chronic lymphocytic leukemia.~   "
265887|NCT00080392|"~     This study will test the safety of a drug called EW-A-401 in patients with intermittent~     claudication - pain and discomfort in the legs due to blockages of the arteries. The study~     will also evaluate whether EW-A-401 improves blood flow to the legs. EW-A-401 contains~     genetic material (DNA) that instructs the body to produce specific proteins that promote the~     growth of new blood vessels and may, therefore, improve blood flow to the legs.~      Patients 21 years of age and older with pain or discomfort of one or both legs due to~     blockages of the arteries below the groin may be eligible for this study. Candidates are~     screened with a medical history, physical examination, blood and urine tests, eye~     examination, chest x-ray and CT scan of the chest, and treadmill tests. Patients who are able~     to exercise more than 12 minutes on the treadmill may not enroll in the study.~      Participants undergo the following procedures:~        -  Muscle biopsy: On the first day of the study, patients have a muscle biopsy. This~          procedure is done under local anesthesia with mild sedation. A 1-inch incision is cut~          into the skin over a calf muscle and a small amount of muscle tissue is removed for~          examination by a pathologist.~        -  Drug treatment and tests: About 10 to 13 days after the biopsy, patients are admitted to~          the NIH Clinical Center for 3 to 5 days for drug treatment and tests. They receive 10~          injections of either the study drug (EW-A-401) or placebo (an inactive substance) in~          each leg during a single session lasting about 1 hour. In addition, they have blood and~          urine tests, complete questionnaires about their symptoms, and undergo magnetic~          resonance imaging (MRI), a test that a magnetic field and radio waves to produce~          detailed images of body tissues and organs. For this procedure, the patient lies on a~          table that slides into the scanner (a large hollow tube) for imaging of the blood~          vessels in the legs. Patients wear headphones to muffle loud knocking and thumping~          sounds that occur during the scanning process.~        -  30-day follow-up: Patients return to the Clinical Center three times over 30 days~          following the hospital stay for a medical history, physical examination, and blood and~          urine tests to assess the safety of EW-A-401.~        -  Extended follow-up: Patients return to the Clinical Center at 3, 6, and 12 months after~          hospitalization for a medical history and physical examination, blood and urine tests,~          two treadmill tests, questionnaires about symptoms, and MRI studies, including imaging~          for blood flow measurement. Blood flow to the legs is measured during MRI using large~          blood pressure cuffs inflated around the legs during the scanning. The cuffs are~          inflated very tightly for 5 minutes, and then a dye is injected into an arm vein to~          brighten the images. Additional pictures are taken over the next 5 to 10 minutes. At two~          of these follow-up visits, patients also have an eye examination, and at the 3- or~          6-month visit they have a repeat muscle biopsy of the calf.~      The study lasts 12 months. After 6 months, patients will be told whether they received~     EW-A-401 or placebo. Because EW-A-401 is so new, patients will continue to be contacted every~     year after the study is completed.~   "
265888|NCT00080340|"~     The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib~     (Iressa) in the treatment of non-small cell lung cancer.~   "
265889|NCT00080327|"~     A study to evaluate three doses of aripiprazole versus placebo in patients with an acute~     episode of schizophrenia~   "
265890|NCT00080314|"~     The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus~     placebo in patients with bipolar depression.~   "
265891|NCT00080301|"~     The purpose of this clinical research study is to learn if BMS-247550 added to the approved~     therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth~     of the cancer in women with metastatic breast cancer who are resistant to taxane and received~     anthracycline chemotherapy. The safety of this treatment will also be studied.~   "
265892|NCT00003345|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and irinotecan in~     treating patients who have ovarian, fallopian tube, or peritoneal cancer.~   "
265893|NCT00003192|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients~     with locally advanced, metastatic, or recurrent cancer of the stomach or esophagus.~   "
265894|NCT00003157|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus chemotherapy in~     treating patients who have cancer of the pancreas or stomach.~   "
265895|NCT00003149|"~     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by~     stimulating a person's blood cells to kill multiple myeloma cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-12 given at~     different times in treating patients with multiple myeloma.~   "
265896|NCT00002974|"~     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above~     body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining chemotherapy with whole-body hyperthermia may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of whole-body hyperthermia plus~     combination chemotherapy in treating patients who have advanced sarcoma that is metastatic or~     that cannot be surgically removed.~   "
265897|NCT00080366|"~     This study will evaluate the effectiveness of 1-octanol, a substance similar to alcohol but~     less intoxicating, for treating essential tremor. Essential tremor is an involuntary shaking,~     usually of the hands, for which there is no satisfactory treatment. It affects about 1.4~     percent of the general U.S. population, with the figure climbing to nearly 4 percent among~     people over 40. Results of two previous NIH studies have shown 1-octanol to be promising as a~     potential new treatment. This study will test the effectiveness of 1-octanol on essential~     tremor at doses lower than those given previously.~      Patients 21 years old and older with essential tremor may be eligible for this study.~     Participants are admitted to the NIH Clinical Center for two treatment periods of 1 week~     each, with a 1-week break at home between treatments. Before beginning treatment,~     participants undergo a medical history, physical examination, blood and urine tests, and an~     electrocardiogram (EKG). In addition, tremors are measured using accelerometry, a procedure~     in which a small device, mounted on a piece of cardboard, is taped to the patient's hand for~     about 30 minutes.~      Patients are randomly assigned to one of two groups. One group takes 2 to 4 capsules of~     1-octanol 3 times a day for 1 week, followed by a 1-week washout period (no treatment), and~     then 2 to 4 capsules of placebo 3 times a day for 1 week. Following the same dosage schedule,~     the second group takes placebo the first week, followed by the washout period and then~     1-octanol treatment. Blood pressure and pulse are measured at 15, 30, and 60 minutes after~     the first dose of the day and then 3 times a day each day of hospitalization, EKG and blood~     draws are done every other day during hospitalization, and blood is drawn again 1 week after~     the end of the study. Patients evaluate their tremor daily according to a tremor scale and~     are also rated according to an alcohol intoxication scale.~   "
265898|NCT00080353|"~     This study will examine the effectiveness of treating advanced melanoma with special~     tumor-fighting cells taken from the patient's blood or tumor and grown in the laboratory. The~     cells are given along with infusions of a growth factor-like substance called interleukin-2~     (IL-2) and an experimental vaccine called fowlpox gp100. This vaccine consists of a peptide~     (part of a protein) called gp100 that is often found in melanoma tumors and chicken virus~     (fowlpox) that has been altered so that it cannot produce illness in humans.~      Patients 16 years of age and older with melanoma that has spread beyond the original site and~     that does not respond to standard treatment may be eligible for this study. Candidates are~     screened with a medical history and physical examination, chest x-ray, electrocardiogram,~     blood and urine tests, and x-rays and scans to the evaluate the extent and size of the tumor.~     Because the experimental preparation is based on tissue type, only patients with tissue type~     HLA-A*0201 may participate. Tissue type is determined by a blood test.~      Participants undergo the following procedures:~        -  Leukapheresis, a procedure for collecting lymphocytes (white blood cells): Using this~          procedure, special cells with good tumor-fighting ability are selected and removed for~          later re-infusion into the patient. To collect the cells, blood is withdrawn through a~          needle in an arm vein and directed through a catheter into a cell-separating machine.~          The lymphocytes are removed and the rest of the blood is returned to the body through~          the same needle. Alternatively, lymphocytes may also be collected from biopsied tumor~          tissue, obtained either with a needle or by a small cut in the tumor.~        -  G-CSF injections: This growth factor is injected under the skin every day for 5 days to~          stimulate white blood cell production.~        -  Catheter placement: Upon admission to the Clinical Center for treatment, the patient has~          a catheter (plastic tube) placed in a vein in the neck or arm for giving chemotherapy~          and other medicines, for infusing the lymphocytes, and for collecting blood samples.~        -  Leukapheresis: Repeated in the hospital to collect and store blood that may be needed in~          the rare event that the patient's blood components do not recover after chemotherapy.~        -  Chemotherapy: A week before the lymphocyte infusion, patients receive a 1-hour infusion~          of cyclophosphamide for 2 days and then a 15- to 30-minute infusion of fludarabine for 5~          days to suppress the immune system and thereby prevent rejection of the infused~          lymphocytes.~        -  Vaccine and lymphocyte delivery: The vaccine is injected through the catheter, followed~          by a 30-minute infusion of the lymphocytes.~        -  IL-2 and G-CSF: Patients receive IL-2 infusions every 8 hours for up to 5 days after the~          cell infusion to help keep the cells alive, and G-CSF injections under the skin every~          day after the cell infusion until white cells increase to a sufficient number. The~          entire hospital stay is usually 12 to 16 days.~      About 4 weeks after the lymphocyte infusion, patients are re-admitted to the hospital for~     about 10 days for a second vaccine injection and course of IL-2 infusions. Between 2 and 4~     weeks after completing the full treatment regimen, patients return to NIH for evaluation.~     Those whose tumors have shrunk or remained stable may repeat the entire treatment regimen two~     times. Those whose tumors continued to grow may be re-treated with infusion of lymphocytes~     through an artery instead of a vein if their tumors receive blood from a major artery. If~     this is not feasible, or if it is tried without success, the patients will be taken off the~     study.~   "
265899|NCT00080288|"~     The primary objective of this study is to determine whether treatment with Armodafinil~     (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness~     associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from~     the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600,~     and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.~   "
265900|NCT00080275|"~     The purpose of this 24 week study is to compare the effectiveness and safety of different~     doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood~     (dyslipidemia).~      At least 600 subjects with a similar medical condition will take part in this study.~   "
265901|NCT00080262|"~     The purpose of this research study is to assess the response rate of the investigational drug~     BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an~     anthracycline, a taxane, and capecitabine.~   "
265902|NCT00080236|"~     The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing~     liver damage that normally occurs when livers are transported before being transplanted and~     in the immediate post-transplant period.~   "
265903|NCT00080223|"~     To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with~     pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).~   "
265904|NCT00080158|"~     The purpose of this study is to compare the effects of three types of treatments for~     depressed teenagers who have attempted suicide.~   "
265905|NCT00012142|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase II trial to determine the effectiveness of CCI-779 in treating~     patients who have progressive prostate cancer.~   "
265906|NCT00002950|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as sargramostim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of topotecan plus sargramostim in~     treating patients who have advanced cancer.~   "
265907|NCT00002947|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.~     Giving radiation therapy in different ways may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating~     patients who have refractory cancer.~   "
265908|NCT00002887|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug is a way to kill more tumor cells.~      PURPOSE: Phase I trial to study the effects of hydroxyurea plus combination chemotherapy in~     patients with non-small cell lung cancer.~   "
265909|NCT00002759|"~     Phase I trial to study the effectiveness of irinotecan plus cyclosporine and phenobarbital in~     treating patients who have solid tumors or lymphoma that is refractory to standard therapy.~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Cyclosporine and phenobarbital may enhance the effectiveness of irinotecan.~   "
265910|NCT00002592|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous~     bone marrow transplantation in treating patients with chronic myelogenous leukemia.~   "
265911|NCT00002540|"~     This clinical trial studies whether screening methods used to diagnose cancer of the~     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening~     tests may help doctors find cancer cells early and plan better treatment for prostate cancer.~   "
265912|NCT00002536|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so~     that it can be removed during surgery.~      PURPOSE: Randomized phase III trial to compare surgery with or without chemotherapy in~     treating patients who have stage IB cervical cancer.~   "
265913|NCT00002461|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. Bone~     marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy to kill more cancer cells.~      PURPOSE: This phase II trial is studying giving high-dose chemotherapy followed by bone~     marrow or peripheral stem cell transplantation to see how well it works in treating patients~     with refractory Hodgkin's disease or non-Hodgkin's lymphoma.~   "
265914|NCT00080210|"~     This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous~     doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects~     must wash out of any uric acid-lowering agents for one week before being dosed, and must~     refrain from using such agents throughout the study.~   "
265915|NCT00080197|"~     The purpose of this study is to determine if E7070 is an efficacious, safe, and tolerable~     treatment for patients with metastatic breast cancer who have failed, or could not tolerate,~     prior treatments with an anthracycline, a taxane, and capecitabine.~   "
265916|NCT00080184|"~     The purpose of this study is to determine whether a new form of brainwave biofeedback is~     effective in the treatment of fibromyalgia.~   "
265917|NCT00080171|"~     Knee osteoarthritis (OA) is the most common cause of disability in adults. The~     Osteoarthritis Initiative (OAI): A Knee Health Study is a nationwide research study that~     will help researchers gather more information about the physical changes that occur prior to~     the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to~     examine people who have knee OA or are at high risk for knee OA; information will be used to~     better understand how to prevent and treat knee OA.~   "
265918|NCT00080145|"~     This 24-week study will compare the safety and effectiveness of medication treatment alone~     (risperidone or aripiprazole) to medication treatment in combination with a parent management~     training program.~   "
265919|NCT00080132|"~     The purpose of this study is to determine if implitapide is effective in lowering~     triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where~     the maximum tolerable medication and diet were not sufficient.~   "
265920|NCT00080119|"~     Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in~     settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with~     high rates of transmission of Mycobacterium tuberculosis (M.tb) to both adults and children.~     Children infected with TB have a higher risk of developing severe disease than adults with~     TB. The purpose of this study was to determine if the antibiotic isoniazid (INH) prevented TB~     infection in infants born to HIV-infected mothers.~   "
265921|NCT00080106|"~     HIV vaccines may help the immune systems of HIV infected patients better control the virus.~     The goal of this study is to determine whether patients on anti-HIV medications can stop~     taking those medications if they receive an HIV vaccine. While taking anti-HIV medications,~     participants will receive either an HIV vaccine or a placebo. Participants will then stop~     taking their anti-HIV medications and the study will compare the viral loads of participants~     who received the vaccine with the viral loads of participants who received the placebo.~      Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean~     HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to~     ART interruption than among participants who received placebo; 2) the time averaged area~     under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART~     interruption step will be lower among participants who received the MRK Ad5 vaccine prior to~     ART interruption than among participants who receive placebo.~   "
265922|NCT00010647|"~     The purpose of this study is to estimate the cost-effectiveness of acupuncture and to~     determine the long-term outcomes and health care utilization of people with osteoarthritis~     (OA) of the knee.~   "
265923|NCT00008320|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ceramide cream in treating women who~     have cutaneous breast cancer.~   "
265924|NCT00008151|"~     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that~     were destroyed by chemotherapy and radiation therapy used to kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin combined with~     fludarabine and total-body irradiation followed by donor peripheral stem cell or bone marrow~     transplantation in treating patients who have advanced acute myeloid leukemia or~     myelodysplastic syndrome.~   "
265925|NCT00006348|"~     RATIONALE: Antiemetic drugs, such as ondansetron, may help to reduce or prevent nausea and~     vomiting in patients with advanced cancer.~      PURPOSE: This randomized phase III trial is studying how well ondansetron works compared to a~     placebo in treating patients with advanced cancer and chronic nausea and vomiting that is not~     caused by cancer therapy.~   "
265926|NCT00006345|"~     RATIONALE: Denileukin diftitox may be able to deliver cancer-killing substances directly to~     T-cell lymphoma cells. Dexamethasone may decrease the side effects of denileukin diftitox.~      PURPOSE: Phase II trial to study the effectiveness of dexamethasone in preventing side~     effects following treatment with denileukin diftitox in treating patients who have persistent~     or recurrent T-cell lymphoma.~   "
265927|NCT00006262|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating~     patients who have refractory stage III or stage IV ovarian epithelial cancer.~   "
265928|NCT00006090|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have chronic lymphocytic leukemia that has relapsed or has not responded to treatment~     with fludarabine.~   "
265929|NCT00006084|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating~     patients who have acute myelogenous leukemia that did not respond to standard treatment given~     in clinical trial PDL 195-301.~   "
265930|NCT00006051|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have head and neck cancer.~   "
266285|NCT00076973|"~     The purpose of this study is to look at whether an investigational drug can treat the~     breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.~   "
265931|NCT00006036|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of liposomal lurtotecan plus cisplatin in~     treating patients who have advanced or metastatic solid tumors.~   "
265932|NCT00006030|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can~     stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast~     cancer by blocking the uptake of estrogen by the tumor cells. Combining radiation therapy and~     tamoxifen with surgery may kill more tumor cells. It is not yet known which treatment regimen~     is most effective for stage I breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of four different treatment~     regimens in treating women who have stage I breast cancer.~   "
265933|NCT00080093|"~     This study will evaluate a new program designed to increase condom use in both women and men.~   "
265934|NCT00080080|"~     The purpose of this study is to determine the antitumor activity (response rate, time to~     tumor progression, survival) and safety of docetaxel in combination with talabostat in~     patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior~     platinum-containing regimen.~   "
265935|NCT00006023|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who~     have metastatic prostate cancer that has not responded to hormone therapy.~   "
265936|NCT00005992|"~     RATIONALE: Vaccines made from a person's peripheral stem cells may make the body build an~     immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have metastatic prostate cancer that has not responded to hormone therapy.~   "
265937|NCT00005972|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have recurrent or refractory small cell lung cancer.~   "
265938|NCT00005944|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor~     cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of second-look surgery with~     or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who~     have colorectal cancer that is recurrent to the peritoneum.~   "
265939|NCT00005865|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs in different ways may kill more tumor cells. It is not~     yet known whether giving vinorelbine by mouth or infusion is more effective in treating non-~     small cell lung cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth~     or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung~     cancer.~   "
265940|NCT00080067|"~     This study will examine how different brain areas are involved in the perception of rhythmic~     patterns and the performance of rhythmic movements. Patients with certain types of brain~     diseases, such as Parkinson's disease and some types of stroke, may have difficulty~     performing rhythmic movements, such as finger tapping.~      Healthy, right-handed volunteers between 21 and 65 years of age may be eligible for this~     study. Candidates with visual, motor or hearing problems are excluded, as are musicians and~     pregnant women.~      Participants will come to the National Institutes of Health (NIH) Clinical Center for up to~     six sessions of functional magnetic resonance imaging (fMRI) scanning. MRI uses a strong~     magnetic field and radio waves to obtain images of body organs and tissues. The scanner is a~     metal cylinder surrounded by a magnetic field. During the MRI, the subject lies still for up~     to 20 minutes at a time on a table in the cylinder and wears earplugs to muffle loud knocking~     noises that occur with the electrical switching of the magnetic fields. He or she can~     communicate with the MRI staff through a microphone at all times during the procedure.~      For fMRI, images are obtained while the subject performs a task, such as hearing sounds or~     moving a finger. The machine detects changes in brain movement that are involved in~     performing the task. The tasks are explained, and subjects can practice them before entering~     the scanner.~   "
265941|NCT00080054|"~     The purpose of this study is to find out about the safety of adding the investigational drug~     motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with~     malignant glioma. Secondly, the study will determine how many patients will respond to this~     treatment.~   "
265942|NCT00080041|"~     The primary purpose of this study is to evaluate the safety, toxicities, and dosage for~     investigational drug Motexafin Gadolinium administered with docetaxel to patients with~     advanced solid tumors. Secondly, tumor response to the combined treatment will be evaluated.~   "
265943|NCT00080028|"~     The purpose of this study is to evaluate the safety of adding the investigational drug~     Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with~     drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.~   "
265944|NCT00080015|"~     This is a Phase II, open-label, multicenter, single-arm, exploratory proof of concept~     study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once~     every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive~     disease after first-line treatment with a platinum-based regimen.~   "
265945|NCT00080002|"~     The purpose of this study is to evaluate the safety and efficacy of pegamotecan~     (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic~     adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed~     following one prior chemotherapy treatment regimen.~   "
265946|NCT00079989|"~     To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected~     serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii,~     Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for~     whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial~     therapies. The primary efficacy endpoint will be the clinical response.~   "
273947|NCT00005325|"~     To seek out genes or genetic markers which identify subjects more vulnerable to hypertension~     under the influence of environmental factors.~   "
265948|NCT00004123|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in~     treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma.~   "
265949|NCT00003817|"~     RATIONALE: Pressure or nerve stimulation applied to an acupuncture point on the inside of the~     wrist may help control nausea and vomiting during chemotherapy.~      PURPOSE: Randomized phase II trial to study the effectiveness of acupressure and~     acustimulation wrist bands in treating nausea and vomiting in patients undergoing~     chemotherapy for cancer.~   "
265950|NCT00003693|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of dolastatin 10 in treating patients who~     have refractory or relapsed acute leukemia, chronic myelogenous leukemia in blast phase, or~     myelodysplastic syndrome.~   "
265951|NCT00003647|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the~     body build an immune response that will kill tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or~     without immunotherapy in treating patients who have stage III or stage IV melanoma.~   "
265952|NCT00079976|"~     To evaluate the safety and efficacy of tigecycline in the treatment of selected serious~     infections caused by VRE. The primary efficacy endpoint will be the clinical response for all~     subjects.~   "
265953|NCT00079963|"~     This randomized placebo-controlled trial will test whether supplementing with vitamins C and~     E can lower markers of inflammation and oxidative stress in healthy adults. We will examine~     whether one antioxidant vitamin is more effective than another, and whether gender or body~     fat influence the treatment effects. We will also determine whether gender, body fat, or~     menopausal status are associated with baseline concentrations of inflammation and oxidative~     stress markers.~   "
265954|NCT00079950|"~     The purpose of this study is to evaluate the safety and efficacy of Pegamotecan~     (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.~   "
265955|NCT00079937|"~     A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key~     role in generating asthma attacks. In patients with allergies, there is an exaggerated~     production of IgE in response to specific substances such as pollens. Omalizumab is a new~     drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against~     asthma attacks in children with allergic asthma.~   "
265956|NCT00003561|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating~     factors such as sargramostim may increase the number of immune cells found in bone marrow or~     peripheral blood and may help a person's immune system recover from the side effects of~     therapy. Combining sargramostim with interferon alfa may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who~     are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in~     remission.~   "
265957|NCT00003356|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a~     person's white blood cells to kill cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining rituximab and interleukin-2~     intreating patients who have low-grade mantle cell lymphoma or follicular lymphoma.~   "
265958|NCT00003327|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with~     recurrent or refractory head and neck cancer.~   "
265959|NCT00003321|"~     RATIONALE: Questionnaires that measure quality of life may improve the ability to plan~     treatment for patients who have cancer of the esophagus.~      PURPOSE: This clinical trial studies quality-of-life assessments of patients with cancer of~     the esophagus who are receiving treatment.~   "
265960|NCT00003274|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not~     yet known what preparation of vaccine therapy is most effective for treating melanoma.~      PURPOSE: Randomized phase II trial to study the effectiveness of tyrosinase/gp100 peptide~     vaccine in treating patients who have stage II melanoma that can be removed by surgery.~   "
265961|NCT00079924|"~     Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or~     Raloxifene.~   "
265962|NCT00079911|"~     This clinical research study will be an international trial evaluating the safety and~     effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression~     of repeated genital herpes infections in HIV-infected subjects with CD4+ count <100~     cells/mm3.~   "
265963|NCT00079898|"~     The purpose of this study is to use brain imaging technology to examine the way acupuncture~     affects brain function.~   "
265964|NCT00079885|"~     To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment~     of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the~     study will be the clinical response in the clinically evaluable population and the clinical~     response in the clinical modified intent-to-treat population at the TOC visit. The primary~     efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If~     tigecycline is found to be noninferior, the analyses will determine whether tigecycline is~     statistically better than levofloxacin.~   "
265965|NCT00079872|"~     In this study, patients will receive either pemetrexed plus irinotecan or 5-fluorouracil~     (5-FU), leucovorin, and irinotecan.~      The purposes of this study are to determine:~        -  How pemetrexed plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms~          of efficacy.~        -  The safety of pemetrexed plus irinotecan and any side effects that might be associated~          with it as compared with 5-FU, leucovorin, and irinotecan.~        -  Whether pemetrexed can help patients with colorectal cancer.~   "
265966|NCT00022360|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of taurolidine in treating patients who~     have recurrent or progressive glioma.~   "
265967|NCT00022165|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. Selenium may be effective in preventing cancer. It is not yet known~     which dose of selenium may be most effective in preventing cancer.~      PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing~     cancer in healthy people.~   "
265968|NCT00021138|"~     RATIONALE: Computer-assisted scheduling of nicotine inhaler use may be an effective method to~     help people stop smoking.~      PURPOSE: Randomized cinical trial to compare the effectiveness of computer-assisted~     scheduling of nicotine inhaler use with that of self-scheduled nicotine inhaler use in~     participants who plan to stop smoking.~   "
265969|NCT00003166|"~     This phase I trial is studying the side effects and best dose of bryostatin-1 when given~     together with vincristine in treating patients with chronic lymphocytic leukemia,~     non-Hodgkin's lymphoma, or multiple myeloma. Drugs used in chemotherapy use different ways to~     stop cancer cells from dividing so they stop growing or die. Combining more than one drug may~     kill more cancer cells~   "
265970|NCT00002789|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell or bone marrow transplantation may be able~     to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.~     Sometimes the transplanted cells can make an immune response against the body's normal~     tissues. Stem cells that have been treated in the laboratory with filgrastim may prevent this~     from happening. Combining chemotherapy with bone marrow or peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     cancer cells. It is not yet known which treatment is more effective for chronic myeloid~     leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of donor peripheral stem~     cell transplantation with donor bone marrow transplantation in treating patients with chronic~     myeloid leukemia.~   "
265971|NCT00079859|"~     The purpose of this study is to determine if implitapide, used in conjunction with other~     lipid-lowering therapies, is safe and effective when compared to placebo in lowering~     low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial~     hypercholesterolemia (HeFH).~   "
265972|NCT00079846|"~     The purpose of this study is to determine if implitapide, used in conjunction with other~     lipid-lowering therapies, is safe and effective when compared to placebo in lowering~     low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial~     hypercholesterolemia (HoFH).~   "
265973|NCT00079833|"~     This research study will determine if esomeprazole, when administered twice daily at 40, 80,~     or 120 mg doses, can control excessive stomach acid secretion.~   "
265974|NCT00079820|"~     The purpose of this study is to gather information on the safety and the effectiveness of an~     investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major~     causes of death and sickness through the first half of the 20th century, but a global program~     of smallpox eradication resulted in the elimination of the natural disease. The last cases of~     smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who~     work with smallpox-related viruses, military personnel, and health care workers are~     vaccinated.~      Historically, individuals in the US were vaccinated with a product such as Dryvax®, which~     contains the virus vaccinia in the same family as smallpox. This virus could promote immunity~     to smallpox, but not produce the disease itself. Although effective, these vaccines are not~     safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens),~     children less than 1 year of age, and people with a compromised immune system, occurring in~     certain diseases (HIV positive individuals and AIDS), and following treatment with certain~     types of drugs. It is important to find a safe vaccine that can be used to protect people who~     cannot receive routine vaccinia-based smallpox vaccine.~      The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the~     objective of this study to find out if MVA vaccine is safe and effective in providing~     immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The~     first way is to find out if there are specific antibodies in your blood following MVA~     vaccination. Antibodies are chemicals your body produces to fight smallpox virus.~      The second way is to see whether or not there is a typical skin reaction following~     vaccination with a traditional smallpox vaccine, given about three months after vaccination~     with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is~     formation of a blister or pox which occurs at the site of vaccination. In a person with~     immunity to smallpox the skin reaction is much less, and typically consists of a little~     swelling at the site of vaccination.~   "
265975|NCT00020930|"~     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of cetuximab in treating patients who have~     stage IV colorectal cancer that has not responded to previous treatment.~   "
265976|NCT00020865|"~     RATIONALE: Levofloxacin may be effective in reducing fever and controlling other symptoms of~     neutropenia in patients who are being treated for cancer. It is not yet known whether~     levofloxacin is more effective than cefepime in reducing fever and controlling symptoms of~     neutropenia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of levofloxacin with that of~     cefepime in reducing fever and controlling symptoms of neutropenia in patients who are being~     treated for cancer.~   "
265977|NCT00014300|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who~     have recurrent glioblastoma multiforme.~   "
265978|NCT00012337|"~     RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep~     growing. Drugs such as ZD 1839 may interfere with the growth factors and cause tumor cells to~     die.~      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have~     metastatic kidney cancer.~   "
265979|NCT00009737|"~     This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in~     combination with leucovorin, in patients who have undergone surgery for colon cancer.~     Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21~     days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every~     28 days. The anticipated time on study treatment is 3-12 months, and the target sample size~     is 500+ individuals.~   "
265980|NCT00006812|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who~     have recurrent ovarian epithelial or primary peritoneal cavity cancer.~   "
266000|NCT00004926|"~     RATIONALE: ILX23-7553 may help solid tumor cells develop into normal cells.~      PURPOSE: Phase I trial to study the effectiveness of ILX23-7553 in treating patients who have~     solid tumors that have not responded to previous therapy.~   "
266123|NCT00007007|"~     RATIONALE: Assessment of patients undergoing radiation therapy may help to determine the~     effects of the treatment and may help improve cancer treatment.~      PURPOSE: This clinical trial is studying the memory skills in patients receiving radiation~     therapy for brain metastases.~   "
265981|NCT00006708|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells~     and either kill them or deliver cancer-killing substances to them without harming normal~     cells. It is not yet known whether combination chemotherapy is more effective with or without~     rituximab for non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without rituximab in treating patients who have relapsed or refractory non-Hodgkin's~     lymphoma.~   "
265982|NCT00006218|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of 3-AP in treating patients who have~     advanced cancer.~   "
265983|NCT00006215|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~     Colony-stimulating factors such as filgrastim may increase the number of immune cells found~     in bone marrow or peripheral blood and may help a person's immune system recover from the~     side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     filgrastim in treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
265984|NCT00006098|"~     RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth.~      PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have~     hematologic cancer.~   "
265985|NCT00079807|"~     HIV is associated with painful peripheral neuropathy. Disability is often significant.~     Alpha-Lipoic Acid's antioxidant properties may have benefit in this condition.~   "
265986|NCT00079794|"~     The purpose of this study it to determine whether supplemental treatment with Iscar improves~     immune function and quality of life among Stage IV non-small cell lung carcinoma patients~     receiving conventional chemotherapy. Iscar is an herbal medicine made from the total plant~     extract of mistletoe. this preparation is already in use in Europe and its use in the US is~     likely to increase as cancer patients continue to seek alternative therapies.~   "
265987|NCT00079781|"~     The RNS® System is intended to treat patients with medically refractory (hard to treat)~     epilepsy. The RNS® System Feasibility study is designed to demonstrate safety and evidence of~     effectiveness of the RNS® System to support the commencement of a pivotal clinical~     investigation.~   "
265988|NCT00079755|"~     To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's Disease and~     anaplastic large cell lymphoma (ALCL).~      As of March 22, 2005, interim analysis of the Hodgkin's Disease (HD) arm has been completed~     per the statistical plan in the protocol. SG030-0003 is now closed to further recruitment of~     HD patients.~   "
265989|NCT00079742|"~     This is a Phase II, multicenter, randomized, controlled, open-label trial of the safety and~     efficacy of Nutropin AQ administered subcutaneously (SC) daily in prepubertal children with~     CF and growth restriction.~   "
265990|NCT00079716|"~     The purpose of this study is to determine the safety and activity of SGN-40 in a weekly~     dosage schedule as a single agent.~   "
265991|NCT00006091|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have chronic phase chronic myelogenous leukemia that has not responded to previous~     treatment.~   "
265992|NCT00006085|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of CP-609,754 in treating patients who have~     advanced solid tumors.~   "
265993|NCT00006026|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have metastatic cancer of the urinary tract.~   "
265994|NCT00005866|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known~     if total-body irradiation plus peripheral stem cell transplantation is more effective with~     busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of busulfan with that of~     cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell~     transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia.~   "
265995|NCT00005848|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have~     progressive, metastatic prostate cancer that has not responded to hormone therapy.~   "
265996|NCT00005834|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Thalidomide may stop the growth of tumor cells by stopping blood~     flow to the tumor. It is not yet known if combination chemotherapy is more effective with or~     without thalidomide for multiple myeloma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without thalidomide in treating patients who have refractory multiple myeloma.~   "
265997|NCT00005635|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of two different regimens of~     trastuzumab plus paclitaxel in treating women who have metastatic breast cancer that~     overexpresses HER2.~   "
265998|NCT00005085|"~     Phase II trial to study the effectiveness of rebeccamycin analog in treating patients who~     have metastatic or locally recurrent colorectal cancer. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die.~   "
265999|NCT00005037|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have stage IIIB, stage IV, or recurrent non-small cell lung cancer.~   "
266001|NCT00004913|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced solid tumors.~   "
266002|NCT00004909|"~     RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help~     determine the intermediate- and long-term effects of the treatment on these patients.~      PURPOSE: This clinical trial studies the effects of chemotherapy given by mouth versus~     chemotherapy given by infusion on quality of life in patients with recurrent ovarian~     epithelial cancer.~   "
266003|NCT00004865|"~     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cetuximab plus cisplatin in treating~     patients who have metastatic or recurrent cancer of the head and neck that has not responded~     to previous cisplatin-based chemotherapy.~   "
266004|NCT00079703|"~     To test the hypothesis that the responsiveness of major and emerging cardiovascular disease~     risk factors to changes in diet composition clusters within families depending on genetic~     susceptibility factors.~   "
266005|NCT00079690|"~     To localize and identify new genes related to variation in blood pressure (BP) responses to a~     low dietary sodium intake, a high dietary sodium intake, oral potassium supplementation, and~     the cold pressor test.~   "
266006|NCT00004864|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Gene therapy such as GEM 231 may inhibit the growth of cancer cells~     and make the tumor more sensitive to chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of combining docetaxel and GEM 231 in~     treating patients who have recurrent or refractory solid tumors.~   "
266007|NCT00004863|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of paclitaxel and GEM 231 in treating~     patients who have recurrent or refractory solid tumors.~   "
266008|NCT00004163|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who~     have advanced salivary gland cancer.~   "
266009|NCT00004151|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating~     patients who have advanced non-small cell lung cancer that cannot be treated with surgery.~   "
266010|NCT00004142|"~     RATIONALE: Radiofrequency ablation may be able to shrink or destroy cancer cells. Drugs used~     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Chemotherapy delivered directly into the blood vessels of the liver may prevent new~     tumors from growing. Combining these therapies may be an effective treatment for colorectal~     cancer that has spread to the liver.~      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation followed by~     chemotherapy delivered directly into the blood vessels of the liver in treating patients who~     have colorectal cancer that has spread to the liver.~   "
266011|NCT00004109|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation~     therapy in treating patients who have soft tissue sarcoma.~   "
266012|NCT00003959|"~     RATIONALE: A vaccine made from a person's myelodysplasia cells may make the body build an~     immune response to kill cancer cells. Combining vaccine therapy with sargramostim may kill~     more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in~     treating patients who have myelodysplastic syndrome.~   "
266013|NCT00003779|"~     RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system~     and stop cancer cells from growing. It is not yet known which type of BCG is more effective~     for bladder cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different types of~     BCG in treating patients who have bladder cancer.~   "
266014|NCT00003772|"~     RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help~     determine the intermediate- and long-term effects of treatment.~      PURPOSE: This clinical trial studies the quality of life in patients with ovarian cancer.~   "
266015|NCT00003742|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients with locally advanced or metastatic solid tumors.~   "
266016|NCT00003706|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemotherapy drugs may have different effects in patients with~     different degrees of kidney function.~      PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have~     locally advanced or metastatic solid tumors and varying degrees of kidney function.~   "
266017|NCT00003705|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of BMS-184476 in treating patients who have~     advanced solid tumors.~   "
266018|NCT00003704|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as~     capecitabine may make the tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with~     radiation therapy in treating patients who have unresectable, residual, or recurrent~     colorectal cancer located in the pelvis.~   "
266020|NCT00003695|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with surgery may kill more tumor cells. It~     is not yet known whether chemotherapy plus surgery is more effective than chemotherapy alone~     in treating patients with stage II or stage III ovarian cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or~     without surgery in treating patients with stage II or stage III ovarian cancer.~   "
266021|NCT00079768|"~     This study will examine the safety and effectiveness of alemtuzumab (Campath® (Registered~     Trademark)) for improving muscle strength in patients with sporadic inclusion body myositis~     (s-IBM). The most common inflammatory muscle disease in people over the age of 50, s-IBM~     progresses steadily, leading to severe weakness and wasting of the muscles in the arms and~     legs. The cause of s-IBM is not known, but it may be an autoimmune disease, in which the~     body's immune cells (white blood cells) attack and destroy parts of muscle. Alemtuzumab is a~     laboratory-made antibody currently approved to treat certain leukemias. It has also been used~     to treat patients with autoimmune conditions such as rheumatoid arthritis, vasculitis,~     multiple sclerosis, and tissue rejection associated with transplantation. Alemtuzumab~     destroys white blood cells that have a protein called CD52 on their surface and that might be~     among the cells attacking muscle.~      Patients with s-IBM are eligible for this study. Candidates are screened with physical and~     neurological examinations, blood tests, and an electrocardiogram. Participants undergo the~     following tests and procedures:~        -  Campath administration: Patients are admitted to the NIH Clinical Center for 1 to 1-1/2~          weeks for intravenous infusions of Campath, given every other day for a total of 4~          infusions.~        -  Follow-up visits after infusions: Patients are monitored for up to 1 year with periodic~          blood tests, physical and neurological examinations, medical history, muscle strength~          measurements, and a review of symptoms, including the ability to perform daily living~          activities.~        -  Lymphapheresis: Patients undergo this procedure for collecting large numbers of white~          blood cells twice - once at the beginning of the study and again after 6 months. Blood~          is removed through a needle in an arm vein and flows through a machine that separates it~          into its components by centrifugation (spinning). The white cells and plasma are removed~          and the red cells and platelets are returned to the patients through the same needle or~          through another needle in the other arm.~        -  Muscle biopsy: Muscle biopsies are done in the operating room under local anesthetic. A~          small incision is made in the thigh or upper arm and a small piece of muscle is removed.~          Biopsies are done at the beginning of the study and again after 6 months.~   "
266022|NCT00079729|"~     The purpose of this study is to help researchers use information from HIV infected~     adolescents to design a directly observed therapy (DOT) program that will help adolescents~     take their anti-HIV medications correctly.~   "
266023|NCT00079677|"~     The primary objective of this study is to determine whether treatment with Armodafinil~     (CEP-10953) is more effective than placebo treatment for patients with residual excessive~     sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring~     mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version)~     (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change~     (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).~   "
266024|NCT00079664|"~     The purpose of this study is to examine the effects of Tai Chi, in comparison to conventional~     exercise, on the quality of sleep among sedentary older adults.~   "
266025|NCT00079651|"~     This study will determine whether montessori-based activities can help older adults with~     dementia become more responsive to others.~   "
266026|NCT00079638|"~     The purpose of this study is to evaluate the effectiveness of first-line treatment using~     Niaspan (an extended release version of niacin) and statins versus other drugs that lower~     lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are~     a class of medication that is often prescribed to patients who need to lower their~     cholesterol levels.~   "
266027|NCT00078039|"~     The primary objective of the double blind phase of this study is to evaluate the efficacy and~     safety of 3 fixed dosages of paliperidone ER (6, 9, and 12 mg/day) compared with placebo in~     adult patients with schizophrenia.~   "
266028|NCT00003617|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known whether chlorambucil is more effective than~     observation in treating low-grade lymphoma of the stomach.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of~     no further therapy following anti-Helicobacter therapy in treating patients with low-grade~     lymphoma of the stomach.~   "
266029|NCT00003465|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with~     anaplastic oligodendroglioma.~   "
266030|NCT00003421|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which chemotherapy regimen is more effective for advanced Hodgkin's disease.~      PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in~     treating patients with advanced Hodgkin's disease.~   "
266031|NCT00003368|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Irinotecan may be effective in treating patients with abnormal~     liver or kidney function or who have received radiation therapy.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients with~     solid tumors or lymphoma who have abnormal liver or kidney function or who have had previous~     radiation therapy to the pelvis.~   "
266032|NCT00003361|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of decitabine in treating patients with~     myelodysplastic syndrome.~   "
266033|NCT00003338|"~     RATIONALE: Diagnostic imaging procedures, such as radiolabeled monoclonal antibodies, may~     improve the ability to detect the residual disease in patients who have been treated for~     non-Hodgkin's lymphoma.~      PURPOSE: Phase II/III trial to study the effectiveness of monoclonal antibodies in detecting~     residual disease in patients who have been treated for non-Hodgkin's lymphoma.~   "
266034|NCT00003337|"~     RATIONALE: Diagnostic imaging procedures using radiolabeled monoclonal antibodies may improve~     the ability to detect and stage non-Hodgkin's lymphoma.~      PURPOSE: Phase III trial to study the effectiveness of a radiolabeled monoclonal antibody in~     the detection and staging of patients with non-Hodgkin's lymphoma.~   "
266035|NCT00003212|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether ifosfamide or doxorubicin is more~     effective for advanced or metastatic soft tissue sarcoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of~     doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma.~   "
266037|NCT00003014|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not yet known whether chemotherapy is more effective than radiation therapy for testicular~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with that of~     radiation therapy in treating patients who have stage I testicular cancer.~   "
266038|NCT00002930|"~     RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 positron emission tomography~     (PET) scans, may improve the ability to detect lung and esophageal cancer or their~     recurrence.~      PURPOSE: Phase II/III trial to study the effectiveness of fludeoxyglucose F 18 PET scans in~     measuring response to induction chemotherapy in patients with esophageal and lung cancer that~     may be removed by surgery.~   "
266039|NCT00002928|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with~     recurrent or progressive advanced epithelial ovarian cancer following previous paclitaxel.~   "
266040|NCT00002919|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following~     surgery in treating patients with stage II bladder cancer.~   "
266041|NCT00002901|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of docetaxel in treating patients with~     advanced solid tumors that have not responded to standard therapy or for which there is no~     effective therapy.~   "
266042|NCT00002858|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~     It is not yet known which treatment regimen is more effective for small cell lung cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy~     using two different doses of cyclophosphamide followed by alternating chemotherapy and~     radiation therapy in treating patients with small cell lung cancer.~   "
266043|NCT00079612|"~     The purpose of the study is to:~        -  Find out if BAY 43-9006 prevents the growth of tumors~        -  For patients who have stable cancer status after 3 months of treatment if it is safer~          and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at~          that time.~        -  Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY~          43-9006 (sorafenib) in the treatment of advanced refractory cancers.~        -  Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some~          patients.~   "
266044|NCT00079586|"~     The purpose of this study is to demonstrate that in patients undergoing coronary artery~     bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac~     surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with~     protamine reversal.~   "
266045|NCT00079508|"~     The purpose of this study is to demonstrate that in patients with heparin-induced~     thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type~     II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and~     effective anticoagulant.~   "
266046|NCT00021359|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective~     treatment for multiple myeloma.~      PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and~     dexamethasone in treating patients who have multiple myeloma.~   "
266047|NCT00017030|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients~     who have unresectable advanced or metastatic soft tissue sarcoma.~   "
266048|NCT00016978|"~     Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil and~     leucovorin in treating patients who have metastatic colorectal cancer that has been~     previously treated with irinotecan. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining more than one drug may kill~     more tumor cells.~   "
266049|NCT00014547|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BBR 3464 in treating patients who have~     metastatic small cell lung cancer that has not responded to previous treatment.~   "
266050|NCT00007969|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill tumor cells. Photodynamic therapy may be effective in treating melanoma.~      PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy in treating~     patients who have stage III or stage IV melanoma.~   "
266051|NCT00002823|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if combination chemotherapy given after surgery~     is more effective than surgery alone for non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     following surgery with that of surgery alone in treating patients who have stage I, stage II,~     or stage IIIA non-small cell lung cancer.~   "
266052|NCT00002650|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of folic acid may be an effective way to prevent~     colorectal cancer in patients with polyps that have been surgically removed.~      PURPOSE: Randomized phase II trial to study the effectiveness of high-dose folic acid in~     preventing colorectal cancer in patients who have had polyps surgically removed within 18~     months of the trial.~   "
266053|NCT00002601|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and combining chemotherapy with~     peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy and~     peripheral stem cell transplantation in treating patients who have advanced or recurrent~     sarcoma.~   "
266054|NCT00002581|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination~     chemotherapy with hormone therapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without~     combination chemotherapy in treating postmenopausal women with stage I or stage II breast~     cancer that can be surgically removed.~   "
266055|NCT00002580|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which~     treatment regimen is most effective for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of~     ovarian ablation, and/or combination chemotherapy in treating premenopausal women with stage~     I, stage II, or stage IIIA breast cancer.~   "
266056|NCT00002537|"~     Phase I trial to study the effectiveness of radiation therapy plus topotecan in treating~     patients who have non-small cell lung cancer. Drugs used in chemotherapy use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and~     radiation therapy may kill more tumor cells.~   "
266057|NCT00002526|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     ifosfamide and doxorubicin in patients with advanced sarcoma.~   "
266058|NCT00002508|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may allow doctors to give~     higher doses of chemotherapy and kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation or bone marrow transplantation in treating patients who~     have relapsed or recurrent germ cell cancer.~   "
266059|NCT00002480|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy~     may be an effective treatment for prostate cancer.~      PURPOSE: Phase I trial to study the effectiveness of radiation therapy in treating patients~     who have stage II or stage III prostate cancer.~   "
266060|NCT00002459|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known whether receiving radiation therapy or no further therapy after surgery is more~     effective for cancer of the uterus.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with~     that of no further therapy in treating patients who have stage I or stage II cancer of the~     uterus that has been surgically removed.~   "
266061|NCT00079625|"~     This Phase 1 trial will investigate the safety of a modified stem cell transplant procedure~     for treating advanced breast cancer. Patients with cancers can sometimes benefit greatly from~     transplants of stem cells (cells produced by the bone marrow that mature into blood cells).~     In addition to producing new bone marrow and restoring normal blood production and immunity,~     the donated cells fight any residual tumor cells that might have remained in the body, in~     what is called a graft-versus-tumor effect. However, severe problems, or sometimes even~     death, may follow these transplants as a result of the high-dose chemotherapy and radiation~     that accompany the procedure. Also, donated immune cells called lymphocytes, or T cells,~     sometimes attack healthy tissues in a reaction called graft-versus-host-disease (GVHD),~     damaging organs such as the liver, intestines and skin. This study will use the following~     strategies to try to reduce these risks:~        -  Induction chemotherapy to reduce patients' immunity in an attempt to prevent rejection~          of the donated stem cells~        -  Reduced-intensity conditioning chemotherapy that is easier for the body to tolerate and~          involves a shorter period of complete immune suppression~        -  Removal of lymphocytes from the donor stem cells for transfusion in small quantities at~          monthly intervals following the stem cell transplant to reduce the risk of GVHD~        -  Transplant of specific lymphocytes called Th2/Tc2 cells that may increase the percentage~          of donor stem cells accepted by the patient without significantly increasing GVHD~      Patients between 18 and 75 years of age with advanced (stage IV) breast cancer that does not~     respond to standard therapy may be eligible for this study. Candidates are screened with a~     medical history, physical and dental examinations, x-ray studies and bone marrow biopsies to~     evaluate disease status, blood and urine tests (including a blood test for genetic match with~     the donor), and lung and heart function tests.~      Participants have a central venous line (large plastic tube) placed into a major vein. This~     tube stays in the body during the entire treatment period for infusing the donated stem cells~     and T lymphocytes, giving medications, including chemotherapy and other drugs, antibiotics,~     and blood transfusions, and withdrawing blood samples. Treatment starts with induction~     chemotherapy, in which patients receive one or two cycles of the anti-cancer drugs~     fludarabine and cyclophosphamide. (One cycle consists of 4 days on drug therapy followed by a~     17-day rest period.) G-CSF, a drug that boosts white cell production, is also given to reduce~     the risk of infection. Several days before the transplant procedure, patients begin~     conditioning chemotherapy with higher doses of cyclophosphamide and fludarabine. Three days~     after the conditioning therapy is completed, the stem cells are infused. To help prevent both~     rejection of the donor stem cells and GVHD, patients receive cyclosporine (first by vein and~     later by mouth) for several weeks after the transplant. Infusions of donor lymphocytes begin~     about 6 weeks after the transplant to boost the immune system and enhance the~     graft-versus-tumor effect.~      Patients may leave the hospital when they are able to eat and drink, have no fever or~     infection, and have a normal or near-normal white cell count. They return for follow-up~     visits twice a week for the first 100 days after the transplant, then every 3 months, then 6~     months and then yearly for at least 5 years post-transplant. The visits include a medical~     history, physical examination, and blood draws, as well as disease staging with CT scans~     every month for the first 6 months.~   "
266062|NCT00079599|"~     Patients with AIDS may develop a deficiency of the micronutrient carnitine and such a~     deficiency may contribute to fatigue in these patients. This study will determine whether~     carnitine supplementation will improve fatigue and related symptoms in carnitine-deficient~     patients with AIDS.~   "
266063|NCT00079573|"~     This study will compare the safety and effectiveness of three popular weight loss plans.~     These plans will be compared with the USDA Dietary Guidelines.~   "
266064|NCT00079560|"~     Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are~     used to increase appetite, food intake, and weight in patients with HIV who experience~     unintended weight loss. This study will compare the effects of MJ and Marinol use in~     marijuana smokers who are HIV infected.~   "
266065|NCT00079547|"~     This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins~     diet) with a high carbohydrate diet (conventional USDA diet).~   "
266066|NCT00079534|"~     The purpose of this study is to determine whether individuals praying at a distance (also~     known as Distant Healing) can positively affect the health of people with HIV/AIDS.~   "
266067|NCT00079521|"~     This study will evaluate the effectiveness of therapeutic touch in treating wrist fractures~     in women past menopause.~   "
266068|NCT00079495|"~     We are studying this investigational drug treatment, comparing it with placebo, to evaluate~     whether it is effective in reducing the number of MRI lesions with a minimum number of side~     effects. The investigational drug will be administered in the clinic weekly for 5 injections~     (induction phase) then monthly for 8 additional injections (maintenance phase).~      Approximately 150 male and female patients (100 active and 50 placebo), aged 18 to 55 years,~     with relapsing MS and at least one but no more than 10 total Gd-enhancing lesions on cranial~     MRI scans during the run-in phase will be randomized into this study.~   "
266069|NCT00079482|"~     The purpose of the study is to determine whether CEP-701 given in sequence with induction~     chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML)~     who achieve a second complete remission (CR).~   "
266070|NCT00079469|"~     RATIONALE: Contingency management is a behavioral treatment approach that provides immediate~     rewards for positive change in behavior such as quitting smoking. In this protocol,~     contingency management will be in the form of a cash reward. A smoking cessation~     (stop-smoking) program that combines contingency management with bupropion and counseling may~     be effective in helping cancer survivors stop smoking.~      PURPOSE: Randomized clinical trial to compare the effectiveness of bupropion and counseling~     with or without contingency management in helping cancer survivors stop smoking.~   "
266071|NCT00079456|"~     This phase II trial is studying how well temsirolimus works in treating patients with~     relapsed or refractory multiple myeloma. Drugs used in chemotherapy such as temsirolimus work~     in different ways to stop cancer cells from dividing so they stop growing or die.~   "
266072|NCT00079443|"~     This phase I/II trial is studying the best dose of FR901228 when given together with~     rituximab and fludarabine and to see how well FR901228 works alone in treating patients with~     relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy,~     such as FR901228 and fludarabine, work in different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer~     cells and either kill them or deliver cancer-killing substances to them without harming~     normal cells. Rituximab may increase the effectiveness of chemotherapy drugs by making cancer~     cells more sensitive to the drugs.~   "
266073|NCT00079430|"~     This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal~     carboplatin when given together with paclitaxel and bevacizumab in treating patients who have~     undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary~     peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and~     paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of~     tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin,~     paclitaxel, and bevacizumab are more effective than carboplatin and paclitaxel in treating~     ovarian epithelial or primary peritoneal cancer, or fallopian tube cancer.~   "
266074|NCT00079417|"~     This phase III trial is studying how well giving carboplatin and vincristine together with~     standard local ophthalmic therapy works in treating children with intraocular retinoblastoma.~     Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to~     stop tumor tumor from dividing so they stop growing or die. It is not yet known whether~     neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in~     treating intraocular retinoblastoma.~   "
266075|NCT00079404|"~     This phase I trial is studying the side effects and best dose of~     17-N-allylamino-17-demethoxygeldanamycin in treating young patients with relapsed or~     refractory solid tumors or leukemia. Drugs used in chemotherapy, such as~     17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop cancer cells from~     dividing so they stop growing or die.~   "
266076|NCT00079391|"~     This study will evaluate the safety and effectiveness of stem cell transplantation in which~     the donor's T cells (a type of lymphocyte, or white blood cell) are removed and then added~     back. Certain patients with bone marrow malignancies undergo transplantation of donated stem~     cells to generate new and normally functioning bone marrow. However, T-cells from the donor~     may see the patient's cells as foreign and mount an immune response to reject them, causing~     what is called graft-versus-host-disease (GVHD). Therefore, in this protocol, T-cells are~     removed from the donor cells to prevent this complication. However, because T-cells are~     important in fighting viral infections as well as any remaining malignant cells (called~     graft-versus-leukemia effect), the donor T-cells are given to the patient (added back) at a~     later time after the transplant when they can provide needed immunity with less risk of~     causing GVHD.~      Patients between 10 and 55 years of age with acute or chronic leukemia, myelodysplastic~     syndrome, or myeloproliferative syndrome may be eligible for this study. Prospective~     participants and their donors are screened with a medical history and physical examination,~     blood tests (including a test to match for genetic compatibility), breathing tests, chest and~     sinus x-rays, and tests of heart function. They also undergo a bone marrow biopsy and~     aspiration. For this procedure, done under local anesthetic, about a tablespoon of bone~     marrow is withdrawn through a needle inserted into the hipbone.~      They undergo apheresis to collect lymphocytes for research studies. This procedure involves~     collecting blood through a needle in the arm, similar to donating a unit of blood. The~     lymphocytes are then separated and removed by a cell separator machine, and the rest of the~     blood is returned through a needle in the other arm.~      Before treatment begins, patients have a central intravenous line (flexible plastic tube)~     placed in a vein in the chest. This line remains in place during the stem cell transplant and~     recovery period for drawing and transfusing blood, giving medications, and infusing the~     donated cells. Preparation for the transfusion includes high-dose radiation and chemotherapy.~     Patients undergo total body irradiation in 8 doses given in two 30-minute sessions a day for~     4 days. Eight days before the transplant, they begin taking fludarabine, and 3 days before~     the procedure they start cyclophosphamide.~   "
266077|NCT00079378|"~     This phase I trial is studying the side effects and best dose of decitabine and valproic acid~     in treating patients with refractory or relapsed acute myeloid leukemia or previously treated~     chronic lymphocytic leukemia or small lymphocytic leukemia. Drugs used in chemotherapy, such~     as decitabine, work in different ways to stop cancer cells from dividing so they stop growing~     or die. Valproic acid may stop the growth of cancer cells by blocking the enzymes necessary~     for their growth. Combining decitabine with valproic acid may kill more cancer cells.~   "
266078|NCT00079365|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and gemcitabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Fluorouracil may make the tumor cells~     more sensitive to radiation therapy. Brachytherapy uses radioactive material, such as~     phosphorus P32, placed directly into or near a tumor to kill tumor cells. Combining~     chemotherapy and external-beam radiation therapy with brachytherapy may kill more tumor~     cells.~      PURPOSE: This randomized clinical trial is studying fluorouracil, gemcitabine, external-beam~     radiation therapy, and brachytherapy using phosphorus P32 to see how well they work compared~     to fluorouracil, gemcitabine, and external-beam radiation therapy in treating patients with~     locally or regionally advanced unresectable adenocarcinoma of the pancreas (pancreatic~     cancer).~   "
266079|NCT00079352|"~     This phase I trial is studying the side effects and best dose of flavopiridol when given~     together with gemcitabine and irinotecan in treating patients with unresectable or metastatic~     solid tumors. Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan,~     work in different ways to stop tumor cells from dividing so they stop growing or die.~     Combining more than one drug may kill more tumor cells~   "
266080|NCT00079339|"~     Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make~     tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy~     may kill more tumor cells. This phase I/II trial is studying the side effects and best dose~     of tipifarnib to see how well it works when given together with radiation therapy in treating~     young patients with newly diagnosed brain stem glioma. (Phase I closed to accrual as of~     1/19/06)~   "
266081|NCT00079326|"~     This phase II trial is studying how well giving trastuzumab together with ixabepilone works~     in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as~     trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances~     to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone, work~     in different ways to stop tumor cells from dividing so they stop growing or die. Combining~     trastuzumab with ixabepilone may kill more tumor cells.~   "
266117|NCT00078793|"~     This study will evaluate long-term safety of etanercept with or without other DMARDs in~     children with polyarticular course or systemic juvenile rheumatoid arthritis (JRA) compared~     to a cohort of subjects with polyarticular or systemic JRA receiving methotrexate with or~     without other DMARDs.~   "
266118|NCT00078767|"~     This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused~     Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic~     Stress Disorder (PTSD).~   "
266082|NCT00079313|"~     This study will evaluate the safety and effectiveness of imatinib (Gleevec(Registered~     Trademark)) in patients with chronic myelomonocytic leukemia (CMML) and atypical chronic~     myelogenous leukemia (CML). These conditions cause uncontrolled growth of malignant~     (cancerous) cells in the bone marrow that prevents the bone marrow from functioning normally~     in producing blood cells. The cancer cells also can spill over into the blood and invade~     other organs of the body. Imatinib has been approved by the Food and Drug Administration for~     treating chronic myelogenous leukemia, which has characteristics similar to atypical CML and~     to CMML, and data from other research suggests this drug may be able to produce a remission~     in forms of leukemia other than CML.~      Patients over 18 years of age with atypical CML or CMML may be eligible for this study.~     Candidates are screened with a medical history and physical examination, blood tests,~     electrocardiogram, chest x-ray, and bone marrow aspiration and biopsy (removal of a small~     piece of bone marrow tissue through a needle inserted into the hip bone).~      Participants take imatinib capsules once a day for 2 years. If at any time during the study~     the patient's blood counts begin to rise, disease symptoms develop, or the disease has~     progressed, the dose of imatinib is increased each week until the disease progression is~     stopped. Any patient whose disease does not response to treatment after 6 weeks of increased~     dosing and 30 days at the maximum daily dose of 800 mg is taken off the study and referred~     for different treatment.~      Patients are seen by their referring physician every week for the first 4 weeks of the study,~     every other week for the next 8 weeks, and then monthly until the study is completed. At each~     visit, blood is drawn to monitor for drug side effects and response to therapy. In addition,~     patients come to the NIH Clinical Center every 3 months for a complete history and physical~     examination and for a bone marrow aspiration and biopsy every 6 months to assess the effect~     of treatment on bone marrow cells.~      Patients who leave the study before 2 years are followed with laboratory monitoring for 6~     months after stopping imatinib; those who remain on the drug for the full 2 years are~     monitored for 1 year after stopping the drug.~   "
266083|NCT00079300|"~     RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate~     the immune system and stop tumor cells from growing.~      PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating~     patients with basal cell skin cancer.~   "
266084|NCT00079287|"~     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, gemcitabine, docetaxel,~     paclitaxel, and carboplatin, work in different ways to stop tumor cells from dividing so they~     stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet~     known which combination chemotherapy regimen is more effective in treating non-small cell~     lung cancer.~      PURPOSE: This randomized phase III trial is studying how well giving vinorelbine together~     with gemcitabine and docetaxel works compared to giving paclitaxel together with carboplatin~     in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.~   "
266085|NCT00079274|"~     This randomized phase III trial was originally designed to compare three different~     combination chemotherapy regimens to see how well they work. As of September 1, 2004, the~     study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms~     which were the same as the first 3 but with cetuximab) in treating patients who have~     undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan~     hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as~     cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to~     them without harming normal cells. Combining more than one chemotherapy drug with monoclonal~     antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not~     known at the time this study was developed which combination chemotherapy regimen is more~     effective after surgery in treating colon cancer. This study had several key changes, based~     on the results of other phase III trials. As of 6/1/2005, patients no longer received~     irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on~     arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C~     and F who had not gotten to irinotecan continued on arms A and D, respectively. As of~     8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or~     KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm~     A and arm D. Patients on arm G were treated per physician discretion and followed for disease~     and survival status. KRAS was determined in a central laboratory and was process for all~     patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus~     on patients having wild-type KRAS tumors. All modifications were approved by the Central~     Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety~     Monitoring Board.~   "
266086|NCT00079261|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,~     prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more cancer~     cells.~      PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together~     with gemcitabine to see how well it works compared to giving combination chemotherapy alone~     in treating patients with previously untreated aggressive stage II, stage III, or stage IV~     non-Hodgkin's lymphoma.~   "
266087|NCT00079248|"~     RATIONALE: Hormone replacement therapy may be effective in relieving symptoms of menopause,~     such as hot flashes, night sweats, and vaginal dryness, without causing a recurrence of~     breast cancer.~      PURPOSE: This randomized clinical trial is studying hormone replacement therapy to see how~     well it works in relieving symptoms of menopause in postmenopausal women with previous stage~     I or stage II breast cancer.~   "
266088|NCT00079235|"~     This phase II trial is studying how well CCI-779 works in treating patients with stage IIIB~     non small cell lung cancer (with pleural effusion) or stage IV non-small cell lung cancer.~     Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from~     dividing so they stop growing or die. CCI-779 may also stop the growth of tumor cells by~     blocking the enzymes necessary for their growth.~   "
266089|NCT00079222|"~     RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing~     fungal infections in patients who are undergoing allogeneic stem cell transplantation.~      PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works~     compared to itraconazole in preventing fungal infections in patients who are undergoing~     allogeneic hematopoietic stem cell transplantation.~   "
266090|NCT00079183|"~     This phase II trial studies the side effects and how well sirolimus works as secondary~     therapy in treating patients with chronic graft-versus-host disease (GVHD) that did not~     respond to prior treatment. Sirolimus may be an effective treatment for chronic GVHD~   "
266091|NCT00079170|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. It is not yet known whether garlic~     supplements affect the ability of docetaxel to kill tumor cells.~      PURPOSE: This clinical trial is studying how well giving docetaxel together with garlic works~     in treating patients with locally advanced or metastatic breast cancer.~   "
266092|NCT00079157|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving a~     vaccine with Montanide ISA-51 and sargramostim may cause a stronger immune response and kill~     more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy~     when given together with Montanide ISA-51 and sargramostim in treating patients with stage IV~     breast cancer.~   "
266119|NCT00078754|"~     This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for~     the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder~     (IED).~   "
266093|NCT00079144|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Treating a~     person's lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed~     by chemotherapy. Vaccines made from peptides may make the body build an immune response to~     kill tumor cells. Giving a vaccine with Montanide ISA-51 may cause a stronger immune response~     and kill more tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill tumor~     cells.~      PURPOSE: This phase II trial is studying how well lymphocyte-depleting nonmyeloablative (not~     damaging to bone marrow) chemotherapy followed by autologous lymphocyte infusion, peptide~     vaccine plus Montanide ISA-51, and interleukin-2 works in treating patients with metastatic~     melanoma.~   "
266094|NCT00079131|"~     This phase II trial is studying how well oblimersen works in treating patients with Merkel~     cell cancer. Biological therapies, such as oblimersen, may interfere with the growth of tumor~     cells and slow the growth of Merkel cell carcinoma (skin cancer).~   "
266095|NCT00079118|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one~     chemotherapy drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel~     works in treating patients with refractory metastatic breast cancer.~   "
266096|NCT00079105|"~     RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine,~     prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer~     cells from dividing so they stop growing or die. Combining more than one chemotherapy drug~     may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     older patients with previously untreated Hodgkin's lymphoma.~   "
266097|NCT00079092|"~     RATIONALE: Thalidomide may stop the growth of malignant glioma by stopping blood flow to the~     tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor~     cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving thalidomide together with~     procarbazine works in treating patients with recurrent or progressive malignant glioma.~   "
266098|NCT00079079|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work~     in different ways to stop tumor cells from dividing so they stop growing or die. Giving more~     than one drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with either~     cisplatin or carboplatin works in treating patients with locally advanced, recurrent, or~     metastatic malignant salivary gland tumor (cancer).~   "
266099|NCT00079066|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Best~     supportive care is the use of drugs and other treatments to improve the quality of life of~     patients. Combining cetuximab with best supportive care may slow the growth of the tumor and~     help patients live longer and more comfortably. It is not yet known whether cetuximab~     combined with best supportive care is more effective than best supportive care alone in~     treating metastatic epidermal growth factor receptor-positive colorectal cancer.~      PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to~     see how well they work compared to best supportive care alone in treating patients with~     metastatic epidermal growth factor receptor-positive colorectal cancer.~   "
266100|NCT00079053|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant erlotinib~     when given after completing chemoradiotherapy in treating patients with locally advanced~     squamous cell carcinoma (cancer) of the head and neck.~   "
266101|NCT00079040|"~     This phase II trial is studying how well giving cisplatin and etoposide together with~     bevacizumab works in treating patients with previously untreated extensive-stage small cell~     lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies,~     such as bevacizumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or deliver~     tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill~     more tumor cells.~   "
266102|NCT00079027|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping the cells from~     dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and~     keeping chemotherapy drugs near the tumor. It is not yet known whether doxorubicin is more~     effective with or without chemoembolization in treating unresectable hepatocellular carcinoma~     (liver cancer).~      PURPOSE: This randomized phase III trial is studying doxorubicin given by infusion to see how~     well it works compared to doxorubicin given by chemoembolization in treating patients with~     advanced liver cancer than cannot be removed by surgery.~   "
266103|NCT00079014|"~     This phase I trial is studying the side effects and best dose of 3-AP and doxorubicin in~     treating patients with metastatic or refractory solid tumors. Drugs used in chemotherapy,~     such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop~     growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth and may help doxorubicin kill more cancer cells by making them more~     sensitive to the drug.~   "
266104|NCT00079001|"~     RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain~     or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known~     whether treatment with zoledronate is effective in preventing bone-related events in patients~     who have prostate cancer and bone metastases.~      PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing~     bone-related events in patients who are receiving androgen deprivation therapy for prostate~     cancer and bone metastases.~   "
266120|NCT00078741|"~     This study will develop a cognitive behavioral therapy (CBT) program to treat symptoms of~     post-traumatic stress disorder (PTSD) in people with severe mental illnesses who are treated~     within community mental health systems.~   "
266105|NCT00078988|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, thiotepa, and etoposide, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     chemotherapy with autologous stem cell transplantation may allow the doctor to give higher~     doses of chemotherapy drugs and kill more tumor cells. Isotretinoin may be effective in~     preventing recurrence of glioma. It is not yet known which regimen of chemotherapy plus~     autologous stem cell transplantation with or without isotretinoin is more effective in~     treating recurrent high-grade glioma.~      PURPOSE: This randomized phase III trial is studying high-dose chemotherapy or~     intermediate-dose chemotherapy followed by autologous stem cell transplantation to see how~     well it works compared to high-dose chemotherapy or intermediate-dose chemotherapy followed~     by autologous stem cell transplantation and isotretinoin in treating young patients with~     recurrent high-grade glioma.~   "
266106|NCT00078975|"~     RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways~     to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill~     more tumor cells by making them more sensitive to the drug.~      PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works~     in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.~   "
266107|NCT00078962|"~     This phase I trial is studying the side effects and best dose of GTI-2040 and gemcitabine in~     treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy,~     such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop~     growing or die. GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth and by making tumor cells more sensitive to gemcitabine~   "
266108|NCT00078949|"~     RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and~     cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or~     die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies,~     such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing~     substances to them without harming normal cells. Giving rituximab as maintenance therapy~     after stem cell transplantation may kill any remaining cancer cells. It is not yet known~     which salvage chemotherapy regimen is more effective before autologous stem cell~     transplantation in treating relapsed or refractory non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying salvage chemotherapy using~     dexamethasone, cisplatin, and gemcitabine to see how well it works compared to dexamethasone,~     cisplatin, and cytarabine given before autologous stem cell transplantation in treating~     patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. This trial also is~     studying giving rituximab as maintenance therapy to see how well it works compared to no~     further therapy after stem cell transplantation. Rituximab was added to both salvage~     treatment arms for CD20+ patients in a protocol amendment in 2005.~   "
266109|NCT00078923|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the~     development of early cancer. Soy isoflavones may be effective in delaying the development of~     early prostate cancer.~      PURPOSE: This randomized phase II trial is studying different regimens of soy isoflavones to~     compare how well they work in treating patients who are undergoing radical prostatectomy for~     stage I or stage II prostate cancer (adenocarcinoma).~   "
266110|NCT00078910|"~     RATIONALE: Drugs used in chemotherapy, such as exisulind, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before~     surgery may shrink the tumor so that it can be removed.~      PURPOSE: This phase II trial is studying how well neoadjuvant exisulind works in treating~     patients who are undergoing radical prostatectomy for stage II or stage III prostate cancer.~   "
266111|NCT00078897|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Selenium may be effective in preventing the recurrence~     of adenomatous colorectal polyps.~      PURPOSE: This randomized phase III trial is studying selenium to see how well it works in~     preventing the recurrence of polyps in patients with adenomatous colorectal polyps.~   "
266112|NCT00078858|"~     This phase I/II trial studies whether stopping cyclosporine before mycophenolate mofetil is~     better at reducing the risk of life-threatening graft-versus-host disease (GVHD) than the~     previous approach where mycophenolate mofetil was stopped before cyclosporine. The other~     reason this study is being done because at the present time there are no curative therapies~     known outside of stem cell transplantation for these types of cancer. Because of age or~     underlying health status, patients may have a higher likelihood of experiencing harm from a~     conventional blood stem cell transplant. This study tests whether this new blood stem cell~     transplant method can be made safer by changing the order and length of time that immune~     suppressing drugs are given after transplant.~   "
266113|NCT00078845|"~     RATIONALE: Amifostine may be effective in reducing pain, numbness, tingling, and other~     symptoms of peripheral neuropathy.~      PURPOSE: This phase II trial is studying how well amifostine works in reducing pain,~     numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received~     paclitaxel for solid tumors.~   "
266114|NCT00078832|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. Anastrozole may be effective in preventing breast cancer.~      PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing~     breast cancer in postmenopausal women who are at increased risk for the disease.~   "
266115|NCT00078819|"~     This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with~     Psoriasis.~      This is a Phase 3 blinded, placebo-controlled study.~   "
266116|NCT00078806|"~     Rationale: etanercept inhibits the effects of tumor necrosis factor, which plays an important~     role in the progression of rheumatoid arthritis. A study of children with polyarticular~     course juvenile rheumatoid arthritis showed that Enbrel had efficacy and was generally well~     tolerated in children ages 4-17 who had moderately to severely active disease and who failed~     treatment with one or more disease modifying antiarthritic drugs. The children in the study~     may have had arthritis onset of pauciarticular, polyarticular, or systemic nature. Systemic~     onset juvenile rheumatoid arthritis (SOJRA) may result in approximately one-third of patients~     having significant long-term disability. Purpose: the Phase 4 study is designed to further~     define the safety and efficacy of etanercept in those children with SOJRA.~   "
266124|NCT00006890|"~     RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the~     tumor. Prednisone may be effective in preventing relapse of multiple myeloma.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two doses of thalidomide~     combined with prednisone following peripheral stem cell transplantation in treating patients~     who have multiple myeloma.~   "
266125|NCT00006467|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with ISIS 2503 in~     treating patients who have advanced or metastatic cancer of the pancreas.~   "
266126|NCT00006452|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     gadolinium texaphyrin may make tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation~     therapy in treating patients who have supratentorial glioblastoma multiforme that has not~     been previously treated.~   "
266127|NCT00006350|"~     RATIONALE: Monoclonal antibodies such as daclizumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Peripheral~     stem cell transplantation from a brother or sister may be effective treatment for hematologic~     cancer. Sometimes the transplanted cells can be rejected by the body's tissue. Mycophenolate~     mofetil, tacrolimus, and donor white blood cells may prevent this from happening.~      PURPOSE: Phase II trial to study the effectiveness of mycophenolate mofetil, tacrolimus,~     daclizumab, and donor peripheral stem cell transplantation in treating patients who have~     hematologic cancer.~   "
266128|NCT00006259|"~     RATIONALE: Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor~     and cause less damage to normal tissue.~      PURPOSE: Phase II trial to study the effectiveness of stereotactic radiation therapy in~     treating patients who have brain metastases.~   "
266129|NCT00006253|"~     Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue~     at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher~     on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management~     attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient~     intervention for management of symptoms and support (PIMSS) targeted toward symptom~     management, reducing impact on physical role and social functioning and emotional distress.~     Both groups will continue to receive conventional cancer care.~      When compared with the self-management attention control intervention, patients exposed to~     the experimental intervention will report statistically significant positive effects on the~     following:~        1. The primary outcome--total number of symptoms reported;~        2. The secondary patient outcomes--reduced deterioration in physical role impact and social~          functioning, emotional distress, levels of communication with caregiver about care, and~          communication and satisfaction with provider care; and~        3. Caregiver outcomes--greater involvement in symptom management, increased mastery of the~          caregiving process, reduced levels of depression and burden.~   "
266130|NCT00006126|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in~     treating patients who have melanoma or small cell lung, breast, testicular, or kidney cancer~     that is metastatic or that cannot be treated with surgery.~   "
266131|NCT00006115|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have metastatic colorectal cancer that has not responded to previous~     chemotherapy.~   "
266132|NCT00006018|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of paclitaxel and BMS-214662 in treating~     patients who have advanced solid tumors.~   "
266133|NCT00078715|"~     This study examines if Yohimbine, when given during the sleep cycle, will improve symptoms of~     depression within a matter of hours.~      Purpose: This study will examine whether the drug yohimbine, given at a specific time during~     the sleep cycle, produces chemical changes in the brain similar to those that occur with~     sleep deprivation. It will also see if yohimbine can induce rapid (next day) antidepressant~     effects in patients with major depression. Total sleep deprivation for 36 hours improves mood~     in most patients with major depression in a matter of hours, but the response is usually~     short-lived. Understanding the chemical changes that occur in the body during sleep~     deprivation may help in the development of a rapidly acting antidepressant.Patients with~     major depressive disorder between 18 and 65 years of age may be eligible for this study.~     Candidates are screened with a medical and psychiatric history, physical examination,~     electrocardiogram, and blood and urine tests. Participants are hospitalized at the NIH~     Clinical Center for the study, as follows: Drug-free period: Patients are tapered off their~     anti-depression medications and remain drug-free for 1 week before beginning study phase 1.~     Study phase 1: Patients undergo sleep deprivation for 36 hours. Those whose depression~     improves with sleep deprivation initially and then worsens continue to phase 2. The day after~     sleep deprivation, patients undergo a lumbar puncture (spinal tap). For this test, a local~     anesthetic is given and a needle is inserted in the space between the bones in the lower back~     where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is~     collected through the needle. Study phase 2: Patients spend 1 night in the sleep lab. A~     catheter (plastic tube) is placed in a vein in each arm-one to give yohimbine and the other~     to draw blood samples. A small monitor cuff is placed on a finger to measure the patient's~     blood pressure and blood oxygen levels during the night. While asleep, the patient receives a~     dose of yohimbine or placebo, given over 3 minutes. A lumbar puncture is done the following~     morning. Patients receive no medications for 6 days, and then the sleep lab procedure is~     repeated. Patients who received yohimbine in the previous experiment are switched to placebo,~     and those who were given placebo are switched to yohimbine.~   "
266134|NCT00078689|"~     This study will examine whether the combination of the drugs daclizumab and sirolimus can~     effectively treat adults with uveitis, an eye inflammation. Daclizumab is a monoclonal~     antibody that is designed to prevent a specific chemical interaction needed for immune cells~     called lymphocytes to produce inflammation. Sirolimus is an immune-suppressing drug that also~     controls lymphocyte activity and is marketed to prevent organ rejection in kidney~     transplants.~      Patients 18 years of age and older with non-infectious uveitis in one or both eyes who are~     being treated with daclizumab and have not had a relapse or disease flare for 6 months before~     entering this trial may be eligible for this study. Candidates are screened with a medical~     history and physical examination, blood tests, complete eye examination, and pregnancy test~     for women who can have children. Women of child-bearing potential who enroll in this study~     will have a pregnancy test every 12 weeks.~      After enrollment, participants have the following additional exams:~        -  Fluorescein angiography: This test is done to check for abnormalities of eye blood~          vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in~          the eyes. Pictures of the retina are taken with a special camera that flashes a blue~          light into the eye. The pictures show if any dye has leaked from the vessels into the~          retina, indicating possible abnormalities. This test is done at enrollment and after 1~          year, unless additional tests are needed for medical management.~        -  Pelvic ultrasound and urine test: These tests are done at enrollment and after 1 year to~          check the kidneys, lymph nodes, and pelvic area.~        -  Blood tests: Blood tests are done at enrollment and every 3 to 6 months for laboratory~          and immunology study~      Patients receive daclizumab subcutaneously (under the skin) or in infusions at regularly~     scheduled visits for 52 weeks. At each treatment, blood pressure, pulse, breathing rate, and~     temperature are monitored. After the first 52 weeks, patients whose disease remains quiet~     increase the time between injections to 6 weeks and then to 8 weeks. Patients who are doing~     well at this time may stop daclizumab.~      One or 2 days after the first daclizumab treatment, patients receive 6 mg of sirolimus by~     mouth. Their blood pressure, pulse, breathing rate, and temperature are monitored for at~     least 60 minutes. Two days after the first dose, patients begin 2-mg maintenance doses every~     other day for 2 weeks. If there are no intolerable side effects, the dose is increased to 2~     mg daily for the next 2 weeks. Patients who have no intolerable side effects at that dose~     continue the medication for another 4 weeks. Patients who experience intolerable side effects~     may decrease the medication to every other day or withdraw from the study. After week 78 of~     the study, if the daclizumab treatments are stopped, the sirolimus dose is reduced within 8~     weeks and may eventually be discontinued if the patient continues to do well.~      Patients who experience any of the following will leave the study:~        -  Inflammation flare that requires concomitant treatment with additional systemic~          immunosuppressive medications, such as prednisone or cyclosporine~        -  Disease flares more than twice in the first year~        -  Any disease flares in the second year~   "
266135|NCT00078637|"~     This is a first-in-man, open-label, non-randomized, multiple dose, multiple cycle, dose~     escalation study to determine the MTD, safety, PK, and pharmacodynamics of E7820 in patients~     with a malignant solid tumor or lymphoma.~   "
266136|NCT00006000|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. SU5416 may stop the growth of solid tumors by stopping blood flow~     to the tumor. Combining SU5416 with chemotherapy may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of SU5416 plus irinotecan and cisplatin in~     treating patients who have advanced solid tumors.~   "
266356|NCT00006375|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of LY293111 in treating patients who have~     advanced solid tumors.~   "
266137|NCT00005965|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin-1 plus cisplatin in treating~     patients who have recurrent or advanced cancer of the cervix.~   "
266138|NCT00005947|"~     Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not~     yet known if vaccine therapy is effective for prostate cancer.~      Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in~     treating patients who have metastatic prostate cancer that has not responded to hormone~     therapy.~   "
266139|NCT00005946|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. White blood cells from donors may be able to prevent~     graft-versus-host disease in patients with hematologic cancer that has relapsed following~     donor peripheral stem cell transplantation.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus donor white blood cell~     infusion in treating patients who have relapsed hematologic cancer following donor peripheral~     stem cell transplantation.~   "
266140|NCT00005843|"~     Phase II trial to study the effectiveness of R115777 in treating patients who have metastatic~     pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die.~   "
266141|NCT00078663|"~     This study will evaluate whether a program of systematic oral care can help prevent~     hospital-acquired respiratory infections in patients in intensive care units. Such infections~     occur five times more often in critically ill patients compared with patients in general~     hospital wards and result in longer hospital stays and an increased risk of death. The rate~     of respiratory infection among critically ill patients correlates strongly with the presence~     of disease-causing bacteria in the mucosal areas of the mouth, gums, and teeth, indicating~     that assiduous oral care is especially important in this patient population. This study will~     compare a program of meticulous oral care using oral assessments taught by a dentist and~     dental hygienist with the standard care typically given in intensive care units.~      Critically ill patients 18 years of age and older who are hospitalized in an intensive care~     unit for 3 or more days and whose oral hygiene is dependent on hospital care providers may be~     eligible for this study. Patients will be recruited from intensive care units at four~     Washington, D.C., area hospitals - Suburban Hospital, Washington Hospital Center, Inova~     Fairfax Hospital, and Winchester Medical Center.~      Participants will have their lips, mouth, gums, teeth, and saliva examined several times a~     day to determine their optimum oral care. They will receive standard care, such as flossing,~     brushing, rinsing with a mouthwash, and possibly use of an antiseptic spray that prevents~     bacteria from clinging to the teeth. Small samples of saliva (less than one-fourth of a~     teaspoon) and dental plaque will be collected the day the patient is admitted to the~     intensive care unit and again on days 3 and 5 of their stay in the unit. The saliva sample is~     collected with a small suction tube placed in the corner of the mouth; the plaque specimen is~     collected by gliding a tiny piece of paper over the surface of a front tooth. The samples~     will be examined for any bacteria not normally found in saliva.~   "
266142|NCT00078624|"~     People with knee osteoarthritis (OA) frequently complain of knee instability. This study will~     test whether certain exercises can improve knee stability, reduce pain, and improve physical~     function in people with knee OA.~      Study hypotheses: 1) Participants in the stability training group will demonstrate less pain~     and higher levels of physical function, based on self-report measures of pain and function~     (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a~     physical performance measure of function. 2) During walking and the step down task,~     participants in the stability training group will demonstrate greater knee motion during~     weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios~     of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle~     pairs compared to the standard group. Participants in the stability group will also~     demonstrate greater step lengths, single limb support times, and average walking velocity~     compared to the standard group.~   "
266143|NCT00005595|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have relapsed or refractory Hodgkin's disease.~   "
266144|NCT00005096|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have~     stage II or stage III prostate cancer.~   "
266145|NCT00005035|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who~     have advanced head and neck cancer.~   "
266146|NCT00004914|"~     RATIONALE: Exercise may decrease anemia-related fatigue, improve strength, and build up lost~     muscle tissue. Epoetin alfa may help improve cancer-related anemia, energy levels, and~     quality of life. Exercise plus epoetin alfa may be effective treatment for anemia-related~     fatigue.~      PURPOSE: Phase II trial to study the effectiveness of exercise plus epoetin alfa in treating~     cancer patients who have anemia-related fatigue.~   "
266147|NCT00078598|"~     A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States~     and Europe.~      Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will~     receive 375 mg/m2 of rituximab (US, Canada – Rituxan®; EU - Mabthera®), given as an IV~     infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab~     therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the~     “dosimetric dose,” patients will receive an infusion of unlabeled Tositumomab (450 mg)~     immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi~     (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0,~     Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from~     these three imaging timepoints, the patient’s weight, and platelet count, a patient-specific~     administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be~     calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second~     phase, termed the “therapeutic dose,” patients in Arm B will receive an infusion of unlabeled~     Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered~     activity of Iodine 131–conjugated Tositumomab (35 mg).~      Patients on study will be followed for response and safety at Week 7, Week 13, and every 3~     months for the first and second years, every 6 months for the third year, and then annually~     for the fourth and fifth years. Patients will be followed for safety only annually for years~     6-10.~   "
266171|NCT00003302|"~     RATIONALE: New imaging procedures, such as MRI, may improve the ability to detect breast~     tumors.~      PURPOSE: Diagnostic study to determine the value of MRI in detecting breast tumors in women~     who have had suspicious mammographic or clinical examinations.~   "
266148|NCT00078585|"~     PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the~     immune system can be taught to fight cancer by directing the immune system to attack specific~     targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's.~     This trial will help determine if this vaccine can help fight cancer.~      This multi-center, double-blind, randomized, empty vector-controlled trial is designed to~     evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the~     empty viral vector co-administered with placebo in the treatment of patients with~     androgen-independent prostate cancer (AIPC).~      All patients will be required to sign an informed consent prior to the performance of any~     on-study procedures. Patients will be screened for eligibility within 14 days prior to~     vaccine administration. Patients who meet all inclusion and exclusion criteria will be~     centrally randomized into the study and will receive a unique patient identification number~     and a blinded treatment assignment. The ratio of active treatment to empty vector control~     (placebo) is 2:1.~   "
266149|NCT00078572|"~     This study was designed to compare the efficacy and safety of an oral dual tyrosine kinase~     inhibitor in combination with capecitabine versus capecitabine alone in women with locally~     advanced or metastatic breast cancer that has not responded to previous therapy.~   "
266150|NCT00078507|"~     The purpose of this study is to determine whether facial exercises in conjunction with~     opening exercises routinely provided after facial surgery to correct a facial skeletal~     disharmony will shorten the time until a patient receives no unpleasant or negative facial~     sensation.~   "
266151|NCT00004912|"~     RATIONALE: Megestrol helps improve appetite. Exercise may decrease cancer-related fatigue,~     improve strength, and build up lost muscle tissue. Exercise plus megestrol may be effective~     treatment for cancer-related weight loss.~      PURPOSE: Phase II trial to study the effectiveness of megestrol plus exercise to improve~     appetite, increase strength, gain lean body tissue, and decrease fatigue in patients who have~     cancer-related weight loss.~   "
266152|NCT00004908|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Peripheral stem cell transplantation may allow doctors to give higher doses of~     chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cyclophosphamide~     plus peripheral stem cell transplantation in treating patients who have recurrent or~     refractory Hodgkin's disease or non-Hodgkin's lymphoma.~   "
266153|NCT00004904|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy and radiation therapy used to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of treated donor stem cell transplantation~     in treating patients who have hematologic cancer.~   "
266154|NCT00004898|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Peripheral stem cell transplantation may allow doctors to give higher doses of~     chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy and chemotherapy~     plus peripheral stem cell transplantation in treating patients who have high-grade lymphoma~     or acute lymphoblastic leukemia.~   "
266155|NCT00004235|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and irinotecan in~     treating patients who have advanced cancer of the esophagus or stomach.~   "
266156|NCT00004175|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, doxorubicin, and~     cyclophosphamide in treating women who have previously untreated stage III breast cancer.~   "
266157|NCT00078559|"~     Transplant rejection occurs when a patient's body does not recognize the new organ and~     attacks it. Patients who have kidney transplants must take drugs to prevent transplant~     rejection. Alemtuzumab is a man-made antibody used to treat certain blood disorders. The~     purpose of this study is to test the safety and effectiveness of using alemtuzumab in~     combination with two other drugs, sirolimus and tacrolimus, to prevent organ rejection after~     kidney transplantation. This study will also test whether this combination of medications~     will allow patients to eventually stop taking antirejection medications entirely.~      Study hypothesis: A new strategy of immunosuppression using alemtuzumab, tacrolimus, and~     sirolimus for human renal transplantation will permit a step-wise withdrawal from~     immunosuppressive drugs.~   "
266158|NCT00078546|"~     To determine the safety of the combination of CD45 monoclonal antibody (Mab) followed by~     intravenous injection of EBV specific CTL in patients with nasopharyngeal cancer.~      To compare the expansion, persistence and anti-tumor effects of the EBV specific CTL given~     after CD45 Mab administration with that observed in our first study.~      To obtain preliminary information on the safety and response to an extended dosage regimen of~     EBV-specific CTL in patients, who have stable disease or a partial response after the initial~     dose of EBV-specific CTL.~   "
266172|NCT00003264|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cisplatin plus gemcitabine in treating~     patients with advanced squamous cell head and neck cancer that cannot be treated by surgery~     or radiation therapy.~   "
266173|NCT00003070|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells~     from the toxic effects of chemotherapy. It is not known whether enalapril is more effective~     than a placebo in treating heart damage in patients who received anthracycline chemotherapy~     for childhood cancer.~      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of enalapril~     with a placebo in treating heart damage in patients who received anthracycline chemotherapy~     for childhood cancer.~   "
266192|NCT00015964|"~     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells~     and slow the growth of head and neck cancer.~      PURPOSE: Phase II trial to study the effectiveness of ZD1839 in treating patients who have~     metastatic or recurrent cancer of the head and neck.~   "
266159|NCT00078533|"~     Patients have a type of blood cell cancer, other blood disease or a genetic disease for which~     they will receive a stem cell transplant. The donor of the stem cells will be either a~     brother or sister or another relative or a closely matched unrelated donor. We are asking~     patients to participate in this study which tests if blood cells from the donor that have~     been grown in a special way, can prevent the patients from getting an infection with a virus~     called Cytomegalovirus or CMV.~      CMV is a virus that can cause serious infections in patients with suppressed immune systems.~     It usually affects the lungs and can cause a very serious pneumonia, but it can also affect~     the intestinal tract, the liver and the eyes. Approximately 2/3 of normal people harbor this~     virus in their body. In healthy people CMV rarely causes any problems because the immune~     system can keep it under control. If the patient and/or their donor is positive for CMV, they~     are at risk of developing CMV disease while the patients immune system is weak post~     transplant. Usually, this risk is highest during the first 3-4 months after the transplant.~      CMV disease can be prevented during this time in most people by using drugs that can kill the~     virus such as Ganciclovir, Foscarnet, or Cidofovir . However, these medications have many~     side effects and have to be given daily by vein for approximately 4-5 months after~     transplant. One of the side effects is that it takes the new immune system much longer to~     develop an effective defense against the virus. Therefore, once the medicines are stopped,~     the patients still have a chance to develop CMV disease.~      We want to see if we can use a kind of white blood cell called T cells that we have grown~     from the stem cell donor instead of the regular treatment with Ganciclovir or Foscarnet to~     prevent CMV from flaring up. These cells have been trained to attack CMV virus infected~     cells. We will grow these T cells from blood taken from the donor before the patients~     transplant. These cells are called CMV-specific cytotoxic T-lymphocytes or CMV CTL, and they~     will be given to the patient around 30 days after their transplant.~      We have used this sort of therapy to treat a different virus which can cause problems after~     transplant called Epstein Barr Virus (EBV). Doctors at other places have used similar T cells~     to treat or prevent CMV infections after transplant and have not seen any significant~     problems. These CMV specific cytotoxic T cells are an investigational product not approved by~     the Food and Drug Administration.~   "
266160|NCT00078520|"~     This study is for patients that have chronic lymphocytic leukemia (CLL). This research study~     aims to determine the safety and dosage of special cells that may make the patients own~     immune system fight the cancer.~      To do this, we will put a special gene into cancer cells that have been taken from the~     patients body. This will be done in the laboratory. This gene will make the cells produce~     interleukin 2 (IL-2), which is a natural substance that may help the immune system kill~     cancer cells. Additionally, we will stimulate the cancer cells with another natural protein~     called CD40 ligand (CD40L), which experiments in animal and human cells in vitro demonstrated~     can help IL-2 perform better.~      Some of these cells will then be put back into the patient's body. Studies of cancers in~     animals and in cancer cells that are grown in laboratories suggest that combining substances~     like IL-2 and CD40L helps the body kill cancer cells. An experimental treatment similar to~     this has already been used in children and similar experimental treatments are being used in~     adults with other cancers.~   "
266161|NCT00078468|"~     To determine the response rate in patients with metastatic colorectal cancer who failed~     treatment with a 5-Fluorouracil/Leucovorin regimen and up to one other chemotherapeutic~     regimen (not including adjuvant chemotherapy).~   "
266162|NCT00078494|"~     This study will examine the effectiveness and side effects of an experimental vaccine to~     prevent recurrence of nasopharyngeal cancer. The likelihood of this cancer returning is~     higher in patients whose original lesion was large, whose cancer had spread to the adjacent~     lymph nodes, or who had surgery for metastatic disease (cancer that spread beyond the primary~     site). Nasopharyngeal tumors are caused by a common virus called Epstein-Barr virus, which~     produces a protein called LMP-2. Vaccination with specific pieces, or peptides, of the LMP-2~     protein may boost the immune system's fight against the cancer. The vaccine injections are~     mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the~     immune response to the peptide.~      Patients 18 years of age and older whose nasopharyngeal cancer has been controlled by~     standard treatment with surgery, chemotherapy, or radiation therapy and who are currently~     free of disease may be eligible for this study. Candidates are screened with a physical~     examination and blood and urine tests. x-rays and other imaging studies are also done in~     patients who have not had these tests recently. All candidates are tested for HLA tissue~     type. Only patients with type HLA-A*1101 or HLA-A*2402 - the types on which the two vaccines~     in this study are based - receive vaccine therapy; others are offered standard medical~     treatment and observation.~      Participants are randomly assigned to receive injections of one of two different vaccines~     (LMP-2:340-349 or LMP-2:419-427) to determine which peptide may offer the best immunity. Each~     treatment course consists of weekly immunizations for 8 consecutive weeks. The injections are~     given under the skin of the thigh. After every other treatment course (about every 3 months),~     patients undergo a series of x-rays and scans to look for tumor. The immunizations are given~     at the NIH Clinical Center. Patients are monitored for 1 hour after each injection and have~     blood tests and a physical examination to look for treatment side effects. Immunizations may~     continue for up to 12 months as long as the cancer does not return.~      Patients are followed with blood tests every 12 weeks to monitor body functions. They also~     undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and~     about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect the action of~     the immune system cells. For this procedure, blood is drawn through a needle in the arm,~     similar to donating blood. The blood is processed by a machine that separates and removes the~     lymphocytes (white blood cells), and the rest of the blood is returned through a needle in~     the other arm. Patients not receiving the vaccine also undergo leukapheresis to assess their~     natural response to LMP-2. Some patients may have a biopsy-surgical removal of a small piece~     of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the~     vaccine's effects on the tumor immune cells.~      Patients who show no evidence of immunization against the LMP-2 protein after two courses of~     vaccine treatment are subsequently be followed with observation alone. Those who do respond~     to the vaccine are offered two additional courses of treatment to strengthen the response or~     to be followed by observation alone. Patients whose disease recurs after completing the first~     two treatment courses are taken off the study and referred back to their local physician or~     to another study, if an appropriate one is available.~   "
266163|NCT00078481|"~     This study will determine the highest amount of idebenone that can be taken without harmful~     side effects in children, teenagers, and adults with Friedreich's ataxia, a progressive~     degenerative disease that affects several body systems. Studies in France and Canada showed~     that patients with Friedreich's ataxia who took idebenone had a decrease in the size of their~     left ventricle (main pumping chamber of the heart), which is often enlarged in this disease.~     It is possible that idebenone may also prevent the progression of nervous system degeneration~     in Friedreich's ataxia.~      Patients 5 years of age and older with Friedreich's ataxia may be eligible for this study.~     Candidates are screened with a blood test and review of their medical records, including~     genetic studies.~      Participants undergo the following procedures during a 6-day hospital admission to the NIH~     Clinical Center:~        -  Placement of an intravenous catheter (plastic tube inserted into a vein) for collecting~          blood samples after drug administration~        -  Blood and urine tests~        -  Heart examination, including electrocardiogram (EKG), to assess heart function and size.~        -  Idebenone therapy: Patients take three tablets a day (at 7 AM, 1 PM and 7 PM) on days 2,~          3 and 4 of hospitalization. Blood samples are collected through the IV tube at 0.5, 1,~          2, 4, and 6 hours after the first dose on day 2, then at 1 hour after the first and~          third doses every day, and then at 1, 2, 4, 8, 12, 24, 36, and 48 hours after the last~          dose on day 4 to determine how the body uses and eliminates the drug.~        -  Monitoring for drug side effects: Patients have frequent checks of vital signs (blood~          pressure, pulse, temperature, breathing rate) and a brief physical examination to check~          for drug side effects from the start of drug therapy on day 2 until at least 43 hours~          after the last dose on day 4.~      Patients who experience no difficulties are discharged from the hospital after the sixth day~     with a 1-month supply of medication to take 3 times a day at home. They are contacted by~     phone every 2 weeks while taking the medication to check side effects. Blood tests are also~     done every 2 weeks to check for any abnormalities.~   "
266164|NCT00078455|"~     This is a Phase II, non-randomized, open label study of ILX651 in patients with locally~     advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will~     be enrolled in this study that is expected to last 18 months. All patients will be treated~     with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days.~     The primary objective of this study is to determine the overall response rate. The secondary~     objectives are to determine the progression free survival, duration of response, time to~     tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic~     profile.~   "
266165|NCT00078429|"~     To investigation the association of thrombosis and inflammation genes with sub-clinical~     cardiovascular disease and with incident myocardial infarction and stroke in older adults.~   "
266166|NCT00078221|"~     AMD is a progressive disease of the retina which is nourished by a network of tiny blood~     vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in~     patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of~     large proteins, fats and other substances from the blood, improving blood flow to the macula,~     potentially improving vision.~   "
266167|NCT00004171|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral~     stem cell transplantation in treating patients who have Hodgkin's disease or non-Hodgkin's~     lymphoma.~   "
266168|NCT00004091|"~     RATIONALE: Examining biomarkers in abnormal cervical cells may improve the ability to detect~     these cells and plan effective treatment.~      PURPOSE: Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women~     who have abnormal Pap test results.~   "
266169|NCT00003528|"~     Phase I trial to study the effectiveness of raltitrexed in treating children with refractory~     acute leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die~   "
266170|NCT00003351|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of irinotecan~     in treating patients who have refractory metastatic breast cancer.~   "
266174|NCT00003040|"~     RATIONALE: Laser surgery for cancer of the larynx may have fewer side effects and improve~     recovery. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining~     radiation therapy and laser surgery may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of laser surgery plus radiation therapy in~     treating patients with early stage cancer of the larynx.~   "
266175|NCT00002825|"~     Phase II trial to study the effectiveness of docetaxel in treating children with recurrent~     solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die.~   "
266176|NCT00002652|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients who have~     refractory or relapsed multiple myeloma or Castleman's disease.~   "
266177|NCT00026429|"~     RATIONALE: Biological therapies such as denileukin diftitox may be able to deliver~     cancer-killing substances directly to non-Hodgkin's lymphoma cells.~      PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating~     patients who have non-Hodgkin's lymphoma.~   "
266178|NCT00025012|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Isotretinoin may be effective in preventing the~     development or recurrence of skin cancer.~      PURPOSE: Clinical trial to study the effectiveness of isotretinoin in preventing or slowing~     the growth of skin cancer in patients who have xeroderma pigmentosum or basal cell carcinoma.~   "
266179|NCT00024037|"~     RATIONALE: Laser therapy may reduce the severity of symptoms and speed healing of oral~     mucositis. It is not yet known if laser therapy is effective in preventing oral mucositis.~      PURPOSE: Randomized phase II/III trial to determine the effectiveness of laser therapy in~     preventing oral mucositis in patients who are undergoing bone marrow transplantation.~   "
266180|NCT00022542|"~     Phase II trial to study the effectiveness of BMS-247550 in treating patients who have~     advanced soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die.~   "
266181|NCT00022308|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation~     therapy in treating patients who have locally advanced non-small cell lung cancer.~   "
266182|NCT00022217|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving more than one drug and giving the drugs in different ways~     may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cisplatin-epinephrine injectable gel~     plus paclitaxel and carboplatin in treating patients who have recurrent head and neck cancer.~   "
266183|NCT00022178|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which combination chemotherapy regimen is more~     effective for metastatic cancer of an unknown site of origin.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients who have metastatic cancer of an unknown site of~     origin.~   "
266184|NCT00021996|"~     RATIONALE: Valdecoxib may be effective in relieving chronic pain in cancer patients. It is~     not yet known if valdecoxib is effective in treating chronic pain.~      PURPOSE: Randomized clinical trial to study the effectiveness of valdecoxib in relieving~     chronic pain in cancer patients.~   "
266185|NCT00021372|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and estramustine~     in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.~   "
266186|NCT00020618|"~     RATIONALE: Morphine that is inhaled may be more rapidly absorbed than morphine that is given~     by mouth. It is not yet known if inhaled morphine is more effective than morphine given by~     mouth in relieving breakthrough pain.~      PURPOSE: Randomized phase II trial to compare the effectiveness of inhaled morphine with that~     of morphine given by mouth in treating cancer patients who have breakthrough pain.~   "
266187|NCT00020098|"~     RATIONALE: Increasing knowledge about the complementary or alternative medicine practices~     used by women who are at increased risk for breast cancer may provide useful information for~     planning breast-cancer-prevention strategies.~      PURPOSE: Clinical trial to determine how many women who are at increased risk for breast~     cancer use complementary or alternative medicine.~   "
266188|NCT00019409|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Giving radiation therapy to the head or intrathecal chemotherapy may prevent cancer~     cells from spreading to the brain. It is not yet known which treatment regimen is more~     effective for acute lymphoblastic leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the~     head or intrathecal chemotherapy plus high dose cytarabine in preventing CNS disease in~     children who have acute lymphoblastic leukemia.~   "
266189|NCT00017303|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and~     by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and~     IM-862 may kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and~     IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal~     cancer.~   "
266190|NCT00016367|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study effectiveness of combining cisplatin, gemcitabine, and~     trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
266193|NCT00002597|"~     RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens~     can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide,~     goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens.~     It is not yet known which regimen of antiandrogen therapy is most effective for prostate~     cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or~     without antiandrogen therapy in treating patients who have stage I or stage II prostate~     cancer.~   "
266194|NCT00002577|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating~     patients with non-small cell lung cancer that cannot be surgically removed.~   "
266195|NCT00002454|"~     RATIONALE: Vaccines made from papilloma virus cells may make the body build an immune~     response to and kill papilloma cells.~      PURPOSE: Phase II trial to study the effectiveness of papilloma virus vaccine in treating~     young patients with recurrent papilloma of the larynx.~   "
266196|NCT00078442|"~     Recombinant interferon (IFN) may be useful in the treatment of HIV. However, the high doses~     of IFN necessary to keep HIV under control limit its use due to toxic side effects. The~     purpose of this study is to test the safety and tolerability of weekly recombinant pegylated~     interferon (PEG-IFN) alfa-2a in HIV infected people who are currently on antiretroviral~     therapy (ART) interruption or who have not started taking anti-HIV drugs.~   "
266197|NCT00078390|"~     A study to measure the safety and effectiveness of S-3304 when given in combination with~     conventional chemo-radiation therapy in patients with locally advanced non-small cell lung~     cancer.~   "
266198|NCT00078377|"~     The primary objective of this study is to determine whether treatment with Armodafinil~     (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness~     associated with narcolepsy by measuring mean sleep latency from the Maintenance of~     Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500)~     and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general~     condition) at week 12 (or last postbaseline observation)~   "
266199|NCT00078338|"~     The primary objective of the study is to assess the clinical efficacy of Rebif® 44 mcg three~     times per week compared with Copaxone® 20 mg daily in patients with relapsing Multiple~     Sclerosis.~   "
266200|NCT00076687|"~     The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A~     in patients with reduced lung function and focal upper limb poststroke spasticity~   "
266201|NCT00014690|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining two or more drugs may kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of ZD9331~     with or without topotecan in treating patients who have refractory or recurrent epithelial~     ovarian cancer, fallopian tube cancer or primary peritoneal cancer.~   "
266202|NCT00014339|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Enzyme products such as Wobe-Mugos E may help to reduce the side~     effects of multiple myeloma therapy. It is not yet known if chemotherapy is more effective~     with or without Wobe-Mugos E in treating multiple myeloma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or~     without Wobe-Mugos E in treating patients who have stage II or stage III multiple myeloma.~   "
266203|NCT00012259|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of troxacitabine in treating patients who~     have blast phase chronic myelogenous leukemia.~   "
266204|NCT00010179|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing of die.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two treatment regimens of~     lurtotecan liposome in patients who have advanced or recurrent ovarian epithelial cancer,~     primary fallopian tube cancer, or peritoneal cancer that has been previously treated with~     chemotherapy.~   "
266205|NCT00006472|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that~     it can be removed during surgery.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy given before surgery in treating patients who have stage I, stage II, or stage III~     esophageal cancer.~   "
266206|NCT00006365|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.~     Giving radiation therapy in different ways may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of external-beam radiation therapy~     followed by implanted radiation therapy in treating patients who have prostate cancer.~   "
266207|NCT00006108|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel,~     and trastuzumab in treating patients who have metastatic breast cancer.~   "
266208|NCT00006037|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. IM-862 may stop the growth of colorectal cancer by stopping blood~     flow to the tumor. It is not yet known if chemotherapy is more effective with or without~     IM-862 in treating colorectal cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy plus IM-862 in~     treating patients who have metastatic colorectal cancer.~   "
266209|NCT00006014|"~     Phase II trial to study the effectiveness of SU5416 in treating patients who have malignant~     mesothelioma. SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to~     the tumor.~   "
266210|NCT00078403|"~     Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal~     liver disease. The purpose of this study was to test the effectiveness of long-term pegylated~     interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in~     people infected with both HIV and HCV.~   "
266211|NCT00078325|"~     The primary objective of this study is to determine whether treatment with Armodafinil~     (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness~     associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep~     latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps~     at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings~     (as related to general condition) at week 12, or last post-baseline visit.~   "
266212|NCT00078312|"~     The primary objective of this study is to evaluate the safety and tolerability of Armodafinil~     (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12~     months to patients with excessive sleepiness associated with a current diagnosis of~     narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal~     continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder~     (SWSD).~   "
266213|NCT00005991|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine and liposomal doxorubicin~     in treating women who have metastatic breast cancer.~   "
266214|NCT00005880|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of budesonide may be an effective way to prevent~     bronchial dysplasia.~      PURPOSE: Randomized double-blinded phase II trial to determine the effectiveness of~     budesonide in treating former or current smokers who have bronchial dysplasia.~   "
266215|NCT00005869|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether nitrocamptothecin is more effective~     than gemcitabine for pancreatic cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with~     gemcitabine in treating patients who have unresectable locally advanced or metastatic~     pancreatic cancer.~   "
266216|NCT00005864|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of chloroquinoxaline sulfonamide in~     treating patients who have stage IV colorectal cancer.~   "
266217|NCT00005593|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of fludarabine, carboplatin, and topotecan~     in treating patients who have relapsed or refractory acute leukemia or advanced~     myelodysplastic syndrome.~   "
266218|NCT00005075|"~     RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body~     temperature. This treatment may be effective for prostate cancer.~      PURPOSE: Phase III trial to determine the effectiveness of ultrasound therapy in treating~     patients who have stage I or stage II prostate cancer that has recurred following radiation~     therapy.~   "
266219|NCT00005026|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer.~   "
266220|NCT00004223|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating~     patients who have progressive regional or metastatic bladder cancer.~   "
266221|NCT00004216|"~     RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune~     system and stop cancer cells from growing.~      PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have~     advanced or metastatic solid tumors that have not responded to previous therapy.~   "
266222|NCT00004183|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who~     have malignant mesothelioma.~   "
266223|NCT00078364|"~     This study will evaluate brain pathways involved in feeling pain and pain relief following~     administration of pain medication. Magnetic resonance imaging (MRI) will be used to measure~     brain activity at sites that become more active following oral surgery and then to see if the~     activity changes after pain medication is administered. MRI combines a powerful magnet with~     an advanced computer system and radio waves to produce detailed pictures of organs and~     tissues. During the scan, the subject lies on a table in a narrow cylinder containing a~     magnetic field. He or she can speak with a staff member via an intercom system at all times~     during the procedure.~      Healthy dental patients recruited through the NIH Clinical Research Volunteer Program may~     enroll in this study. Participants will undergo the following tests and procedures in two~     clinic visits:~      Visit 1 - Sensitivity Testing~      Participants are tested for sensitivity to warm and hot temperatures. A probe is applied to~     the skin (usually the forearm) and heated to temperatures ranging from room temperature to~     that of a hot cup of coffee. Participants rate the temperature using a scale ranging from no~     pain to the worst pain imaginable and rate the unpleasantness of the heat using a similar~     scale. The probe is applied up to 30 times, using random heat intensities. Participants are~     also asked compare the heat intensity to varying levels of sounds and to rate the magnitude~     of different sensations they have experienced in the past, such as the brightness of the sun~     and the loudness of a jet plane. A blood sample of about 2 ounces is also collected at this~     visit for DNA analysis to look for genes related to pain.~      Visit 2 - Oral Surgery~      Under local anesthetic, participants undergo extraction of their lower right wisdom tooth.~     After surgery, the patient is moved to the MRI scanner for brain imaging over 1-2 hours while~     the local anesthetic wears off. Patients may request a postoperative pain drug (Toradol)~     during the procedure, if needed. When the scan is complete, patients are dismissed from the~     clinic with additional pain medication (flurbiprofen) to use at home as directed.~   "
266248|NCT00003572|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow~     transplantation may be able to replace immune cells that have been destroyed by radiation~     therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune~     response against the body's normal tissues. Mycophenolate mofetil and tacrolimus may be an~     effective treatment for graft-versus-host disease caused by bone marrow transplantation.~      PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, tacrolimus, and~     mycophenolate mofetil plus bone marrow transplantation in treating patients with hematologic~     cancers.~   "
266249|NCT00003548|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of aminocamptothecin in treating patients~     with advanced cancer of the peritoneal cavity.~   "
266224|NCT00078351|"~     This study will examine the effectiveness of injected hylan (Synvisc) for treating pain~     associated with osteoarthritis of the temporomandibular joint (jaw joint) and improving~     function of the joint. Hylan is a synthetic product very similar to a component of normal~     healthy joint fluid (synovial fluid), which is present in much lower quantities and is~     abnormal in osteoarthritis. Hylan injections have been beneficial in treating osteoarthritis~     of the knee.~      Patients with temporomandibular (TMJ) joint pain of at least 3 months duration who have mouth~     opening limitation and moderate to severe joint pain made worse by joint movement may be~     eligible for this study. Patients must not have any TMJ growth disturbances and must not have~     had any TMJ surgery for 6 months before entering the study. Candidates are screened with~     questionnaires, a medical history, and a physical examination of the TMJs, including x-rays~     and magnetic resonance imaging.~      Participants are randomly assigned to receive three injections, each a week apart, of either~     Synvisc or placebo (a salt-water solution) into the affected joint. Before the first~     injection, a sample of synovial fluid is collected from the joint by needle aspiration for~     laboratory analysis. Patients return for follow-up visits 3, 6, and 12 months after the last~     treatment for a clinical examination of the jaw joint and review of jaw joint symptoms. A~     second aspiration is requested at the 3-month visit, but is not mandatory. All injections and~     aspirations are done after anesthetizing the overlying skin and joint capsule to minimize~     pain or discomfort. Participants record their daily use of pain relief medication throughout~     the study.~   "
266225|NCT00078286|"~     This study will examine the effect of antidepressant medication on rates of death and disease~     in depressed people with chronic heart failure.~   "
266226|NCT00078273|"~     The overall purpose of this study is to reduce the prevalence of gambling risk in college~     students by evaluating the effectiveness of different treatments in reducing gambling~     behavior and related negative consequences.~   "
266227|NCT00078260|"~     The purposes of this study are to determine:~        -  the safety of pemetrexed and any side effects that might be associated with it~        -  how much pemetrexed should be given to patients.~      It is possible that information collected during this study will be analyzed by the Sponsor~     in the future to evaluate pemetrexed for other possible uses or for other medical or~     scientific purposes other than those currently proposed.~      Although pemetrexed has been shown to be effective in some patients with non-small-cell lung~     cancer, pemetrexed might not have beneficial effects for all patients.~   "
266228|NCT00078299|"~     This study will evaluate a system developed to grade the severity of age-related cataract, a~     common cause of vision loss in older adults. Cataract research requires methods to simply and~     accurately determine the type and severity of cataracts in order to develop new, possibly~     non-surgical, treatments.~      Patients 50 years of age and older with one of the three major age-related cataract types~     (nuclear, cortical, and posterior subcapsular) may be eligible for this study. Participants~     will be recruited from among patients enrolled in other National Eye Institute protocols.~      Participants will have their eyes examined independently by two ophthalmologists with a~     biomicroscope, a magnifying device routinely used during eye examinations. The doctors will~     use the new grading system to record if a cataract is present, and if so, how severe it is.~     The examination includes measurement of visual acuity (vision chart test) and examination of~     the lens, retina, pupils and eye movements. Photographs of the eye will be taken using a~     special camera that flashes a bright light in the eye.~   "
266229|NCT00078247|"~     This study is designed to determine whether 6 months of anti-HIV drugs given along with~     tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.~   "
266230|NCT00078234|"~     The treatment combination of Rituxan® (rituximab) and fludarabine has previously been~     reported to produce a high percentage of responses with less toxicity than other combination~     treatments. However, some leukemia subjects continue to have leukemia despite treatment with~     these standard anticancer drug therapies, or they may work for only a short period of time.~     In some subjects, when the leukemia does not respond well to therapy the leukemia cells may~     be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a~     protein that appears to protect cancer cells from being killed and thus lengthens the life of~     the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the~     Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may~     work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells.~     This study will test whether treating subjects with Genasense®, fludarabine and rituximab is~     safe and effective.~   "
266231|NCT00078169|"~     The purpose of this study is to compare a three-session Spanish version of Motivational~     Enhancement Therapy (MET) to standard treatment to see how well MET engages and retains~     Spanish-speaking clients in outpatient substance abuse treatment.~   "
266232|NCT00078156|"~     The purpose of this study is to compare the effectiveness of adding Seeking Safety to~     standard substance abuse treatment to adding a control condition: Women's Health Education to~     standard substance abuse treatment.~   "
266233|NCT00078143|"~     The purpose of this study is to compare Motivational Enhancement Therapy (MET) with standard~     drug abuse treatment among pregnant women.~   "
266250|NCT00003425|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~     Chemoprotective drugs such as amifostine may protect normal cells from the side effects of~     chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral~     stem cell transplantation and amifostine in treating patients with cancer.~   "
266251|NCT00003411|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin~     gadolinium may increase the effectiveness of radiation therapy by making tumor cells more~     sensitive to treatment.~      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus motexafin~     gadolinium in treating patients with bile duct, gallbladder, or pancreatic cancer that cannot~     be removed surgically.~   "
266303|NCT00005791|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients who have locally advanced or metastatic solid tumors.~   "
266234|NCT00078208|"~     This study will evaluate the usefulness of a new procedure for evaluating asthma in children.~     The method measures the pH (a measure of acidity and alkalinity) of exhaled breath condensate~     (water vapor created by the lungs). The condensate contains products of the lungs that may be~     associated with lung inflammation. Investigators will determine if the pH of the exhaled~     breath condensate correlates well with known asthma indicators, such as number of~     hospitalizations, school absenteeism, use of rescue medication, and others. Test results will~     be compared with findings from healthy normal volunteers. No experimental treatments or~     medicines are used in this study. Patients who require treatment for their asthma will~     receive standard care with medicines approved by the Food and Drug Administration and used~     widely in the United States.~      Children with asthma and healthy normal volunteers between 6 and 17 years of age may be~     eligible for this study. You must complete the study before your 18th birthday. Candidates~     are screened with a medical history and physical examination.~      Children with asthma undergo the following tests and procedures over six clinic visits,~     including an initial visit and follow-up visits at 4-8 weeks, 3, 6, 9, and 12 months:~        -  Blood draw in children over 6 years of age. Medications are available to decrease the~          pain associated with blood drawing.(initial visit)~        -  Allergen skin testing: Drops of up to 16 allergens are placed on the arm. The skin under~          each drop is scratched and the area is observed for an allergic reaction. (4- 8-week~          follow-up visit)~        -  Expired nitric oxide testing: The child breathes into a balloon to collect a portion of~          the gases exhaled form the lungs. This test measures the amount of nitric oxide, which~          correlates with bronchial inflammation. (all visits)~        -  Exhaled breath condensate: The child breathes into a plastic tube surrounded by a cold~          metal sleeve for 10 to 15 minutes. The water vapor created by the lungs (the same vapor~          that forms when breathing outside on a cold day) is collected and the pH measured. (all~          visits)~        -  Pulmonary (lung) function test: The child blows very hard into a tube attached to a~          machine to measure the airflow from the child's lungs. This test measures airflow from~          the lungs. (all visits) The children are given small plastic device called a peak flow~          meter - a device used to measure lung function - to use at home. Children whose lung~          function is less than 80% of the predicted value for their age may be given medicine to~          see if their lung function improves.~        -  Review of the patient's symptoms, sick days, medicines or actions taken to get over the~          illness; review of peak flow reports; and review of action plan. (3-, 6-, 9-, and~          12-month visits)~      Healthy controls will have the expired nitric oxide test, exhaled breath condensate test, and~     pulmonary function test at each visit at the initial and over two additional visits scheduled~     6 months apart.~   "
266235|NCT00078195|"~     A series of allergy shots may reduce symptoms of seasonal ragweed allergies. This study will~     determine whether taking a drug called omalizumab (also known as Xolair) before getting the~     allergy shots is more effective than allergy shots alone or other treatments, such as~     prescription antihistamines.~   "
266236|NCT00078182|"~     Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other~     anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV~     infection. This study will determine if taking a tenofovir DF tablet every day is safe and~     effective in preventing HIV infection. Participants in the study will be sex workers in Phnom~     Penh, Cambodia.~   "
266237|NCT00078130|"~     The purpose of this study is to compare two 3-month treatments for adolescents/young adults~     who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and~     treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of~     psychosocial therapy.~   "
266238|NCT00078117|"~     The purpose of this protocol is to to compare the clinical utility of two dosage tapering~     regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.~   "
266239|NCT00078065|"~     This trial is a phase II, randomized study of patients with multiple myeloma. All patients~     will receive Xcellerated T Cells, with or without prior fludarabine therapy.~      15 patients in each study arm will be followed for 6 months.~   "
266240|NCT00004148|"~     Phase I trial to study the effectiveness of vaccine therapy in treating patients who have~     unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill~     tumor cells.~   "
266241|NCT00003935|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and radiation~     therapy in treating children who have newly diagnosed brain stem glioma.~   "
266242|NCT00003814|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if eflornithine is more effective than no~     further therapy in treating bladder cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in~     treating patients who have newly diagnosed or recurrent bladder cancer.~   "
266243|NCT00003766|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so~     that it can be removed during surgery.~      PURPOSE: Phase II trial to study the effectiveness of O6-benzylguanine followed by surgery in~     treating patients who have solid tumors that can be removed during surgery.~   "
266244|NCT00003623|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of high-dose multivitamins may be an effective~     way to prevent the recurrence of early stage bladder cancer. It is not yet known whether~     high-dose vitamins are more effective than no further therapy in decreasing the risk of~     early-stage bladder cancer.~      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of high-dose~     multivitamins with a placebo in preventing the recurrence of cancer in patients with early~     stage bladder cancer.~   "
266245|NCT00003615|"~     RATIONALE: Immunotoxins such as denileukin diftitox can locate cancer cells and kill them~     without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.~      PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating~     patients who have non-Hodgkin's lymphoma that has not responded to previous treatment.~   "
266246|NCT00003600|"~     RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients~     with cancer who are receiving chemotherapy. It is not yet known whether epoetin alfa is more~     effective than a placebo in treating anemia in patients receiving chemotherapy.~      PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin~     alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.~   "
266247|NCT00003573|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy~     followed by combination chemotherapy in treating children with newly diagnosed advanced~     medulloblastoma.~   "
266263|NCT00003035|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving the drugs in different ways~     may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of doxorubicin with~     paclitaxel in treating women who have locally advanced breast cancer.~   "
266252|NCT00003299|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and~     etoposide alone in treating patients with extensive-stage small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide~     with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.~   "
266253|NCT00003240|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not known whether giving chemotherapy in addition to standard~     therapy is a more effective treatment for lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy given~     with or without combination chemotherapy in treating patients with non-small cell lung~     cancer.~   "
266254|NCT00003120|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter~     period of time is as effective as a standard course of treatment for advanced ovarian cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3~     months with that of paclitaxel given for 12 months in treating patients who have stage III or~     stage IV ovarian, fallopian tube, or primary peritoneal cancer.~   "
266255|NCT00078104|"~     This study will evaluate how well different medications work to relieve pain following third~     molar (wisdom tooth) extraction. Scientists believe that hormone-like substances called~     prostanoids contribute to pain following oral surgery. Prostanoids are produced by~     cyclooxygenase (COX) enzymes. This study will examine how different medicines inhibit the COX~     enzymes and reduce the amount of prostanoids, and thus the amount of inflammation and pain.~     The study will also look at genetic factors involved in the production of prostanoids and the~     response to pain medication. (Only the bottom two wisdom teeth are extracted for this study.~     Patients whose top wisdom teeth also need to be removed will have those teeth extracted, also~     free of charge, at least 2 weeks after the first surgery.)~      Healthy normal volunteers between 16 and 35 years of age who are in general good health and~     who require third molar extraction may be eligible for this study. Candidates are screened~     with a medical history and oral examination, including dental x-rays as needed to confirm the~     need for third molar removal.~      On the morning of surgery, patients have blood drawn to obtain DNA for genetic study. Women~     of childbearing age have a urine pregnancy test. One hour before surgery, patients receive a~     dose of rofecoxib (Vioxx® (Registered Trademark)), acetaminophen (Tylenol® (Registered~     Trademark)), or placebo (a pill with no active ingredient). A half-hour before surgery, they~     receive either a standard painkiller called keterolac (Toradol® (Registered Trademark))) or~     placebo through an arm vein. All patients also receive the sedative midazolam (Versed®~     (Registered Trademark)), also through an arm vein, to induce drowsiness and a local~     anesthetic (lidocaine) to numb the mouth. After the mouth is numbed, but before the wisdom~     teeth are extracted, a biopsy (removal of a small piece of tissue) is conducted in the area~     of the cheek next to the wisdom tooth.~      After the surgery, a small piece of tubing is placed into both extraction sites. Every 20~     minutes for the next 3 hours, inflammatory fluid is collected from the tubing to measure~     chemicals that are believed to cause pain and swelling. Patients complete questionnaires~     every 20 minutes to rate their pain. Those who still have pain an hour after surgery may~     request and receive a rescue drug called tramadol (Ultram® (Registered Trademark)) for pain~     relief. Patients remain in the clinic from 3 to 6 hours to monitor the effects of the study~     drugs as the anesthetic wears off.~      After surgery a second biopsy is done to measure any changes in the chemicals being produced~     in response to the surgery. For this biopsy, patients are assigned to one of two groups - one~     group has the second biopsy within 3 hours of surgery, before taking the rescue drug, and the~     other group returns to the clinic the next morning for a biopsy 24 hours after surgery.~     Patients in the second group leave the clinic after surgery with two pain medications~     (tramadol and the study drug) and forms to record pain ratings at home. They are permitted to~     take only the pain medications provided and only at certain times.~      At the end of their participation in the study, all patients are given the pain medication~     flurbiprofen (Ocufen® (Registered Trademark)) to take at home.~   "
266256|NCT00078091|"~     This study will evaluate patients with a rare inherited condition called Bardet-Biedl~     syndrome . The purpose of the study is to learn more about the genetics and clinical~     characteristics of this disorder. Patients may have the following problems: polydactyly~     (extra fingers and toes); retinal dystrophy (changes in the retina that may lead to vision~     problems, including blindness); obesity and diabetes (overweight and high blood sugar due to~     failure of body organs to respond to insulin); cognitive dysfunction (difficulties with~     learning and understanding); hypogenitalism (decreased functioning of the ovaries in women~     and the testes in men); kidney anomalies (changes in the structure or function of the~     kidneys); heart disease; and hepatic fibrosis (liver disease).~      Patients with Bardet-Biedl syndrome may be eligible for this study. First-degree relatives~     will also be enrolled for certain tests and procedures. Candidates are screened with a review~     of their medical records, laboratory tests, and x-rays.~      Patients in this study undergo the following tests and procedures:~        -  Medical and family history and physical examination, including body measurements.~        -  Blood tests to evaluation kidney, liver, heart, and hormonal function, and for genetic~          studies and other research purposes.~        -  Dual emission x-ray absorptiometry (DEXA) scan to measure the amount of total body fat.~          For this test, the subject lies on a table for scanning with low-dose X-rays.~        -  Computed tomography (in adults) of the abdomen to measure abdominal fat. CT uses a small~          amount of radiation to obtain images of internal body structures.~        -  Magnetic resonance imaging (in children) of the abdomen to measure abdominal fat. MRI~          uses a magnetic field and radio waves to obtain images of internal body structures.~        -  Oral glucose tolerance tests to measure blood glucose and insulin levels. For this test,~          the patient drinks a glucose (sugar) solution. Blood samples are drawn through an IV~          catheter before the test begins and at 1, 2, and 3 hours after drinking the solution.~        -  Complete eye examination to look for retinal changes and to assess vision, and, if~          medically needed, an examination of the ear, nose, and throat to check for hearing and~          breathing abnormalities.~        -  Tests of learning ability in patients over 5 years of age. For younger patients, a~          parent is asked about the child's development.~        -  Ultrasound study of the ovaries and uterus in females and of the testes in males.~        -  Photographs of the face, hands, feet, body, and genitalia, if the patient agrees.~        -  Meeting with investigators and a genetic counselor for review of test findings when the~          studies are completed.~      Relatives of patients have a complete medical and family history and physical examination.~     Blood is drawn for assessment of kidney, liver, heart, and hormonal function and for genetic~     study and other research purposes. Relatives over 5 years of age may have tests of learning~     ability and cognition. For younger patients, a parent is asked about the child's development.~     Relatives meet with investigators and a genetic counselor for review of test findings when~     the studies are completed.~   "
266257|NCT00078078|"~     This study will evaluate patients with methylmalonic acidemia (MMA) to learn more about the~     genetic causes of the various types of this inherited metabolic disorder and the medical~     complications associated with it. People with MMA may have problems with learning and~     development and kidney malfunctioning. They can become seriously ill, sometimes with little~     warning. There is no cure for any MMA, but special diets and vitamin therapies are used for~     treatment.~      Patients between 2 and 70 years of age with MMA may be eligible for this study. Participants~     are admitted to the NIH Clinical Center for 4-5 days each year for 5-10 years for the~     following tests and procedures:~        -  Medical history, physical examination, eye examination~        -  Consultations from dentists and specialists in the nervous system, digestive tract,~          endocrine, and kidney, as needed.~        -  24-hour urine collection to examine for methylmalonic acid, other acids, sugar, and~          proteins for measuring kidney function.~        -  Blood test to assess liver and thyroid function, blood counts and blood chemistries,~          methylmalonic acid levels, and for genetic tests and basic research studies.~        -  Blood test to measure growth hormone production. For this test, a very small amount of~          blood is collected overnight (every 20-30 minutes from 8:00 PM to 8:00 AM) through an~          intravenous catheter (plastic tube placed in a vein). The total amount of blood drawn is~          approximately 1 tablespoon. Patients who have stopped growing or whose weight does not~          permit collection of 1 tablespoon of blood do not undergo this procedure.~        -  Frequent blood pressure measurements, including overnight monitoring~        -  Skin biopsy for cell culture (cells to grow in the laboratory for future testing). For~          this procedure, an area of skin is numbed with an anesthetic such as lidocaine. A 4-mm~          diameter circular area is then removed using a sharp punch and scissors. The wound is~          dressed and usually heals within a week.~        -  Photographs of the face and body (wearing underwear) to help track growth and~          appearance.~        -  Ultrasound of the kidneys~        -  Hand x-ray to determine bone age~        -  Dual energy x-ray absorptionometry (DEXA) scan to assess bone density. For the DEXA~          scan, the patient lies still on a table while the spine and hip are scanned using a~          small amount of radiation.~      Any patient who becomes seriously ill during the evaluation may be cared for at the NIH or~     transferred to another hospital if it is deemed advisable.~   "
266258|NCT00078052|"~     To investigate genetic markers of coronary heart disease in type 2 diabetes.~   "
266259|NCT00078026|"~     Osteoporosis affects millions of postmenopausal women in the USA. The current approved~     treatments are all drugs that prevent bone loss and possibly result in small gains in bone~     mass. Another possible treatment consists of drugs that increase bone formation. There are~     currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid~     hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown~     significant bone formation in animal studies. In this study we plan to test whether APOMINE~     is able to stimulate new bone formation in women with osteoporosis or low bone mass.~   "
266260|NCT00030602|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients~     who have recurrent prostate cancer.~   "
266261|NCT00003089|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells~     from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel, carboplatin, amifostine,~     and radiation therapy in treating patients who have unresectable locally advanced or~     partially resected non-small cell lung cancer.~   "
266262|NCT00003046|"~     RATIONALE: Interleukin-12 may kill tumor cells by stimulating a person's white blood cells to~     kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients with~     cancer in the abdomen.~   "
266282|NCT00077727|"~     The purpose of this study is to determine if adding extended-release galantamine~     hydrobromide, compared with adding placebo, to current atypical antipsychotic therapy is well~     tolerated and effective in improving cognitive impairment in patients with schizophrenia.~   "
266264|NCT00078013|"~     This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The~     primary objectives of this study are to examine the safety, tolerability, and efficacy of~     intravenous MCC-135 in limiting final infarct size, as measured by single photon emission~     computed tomography (SPECT), in patients who require percutaneous coronary intervention (PCI)~     for a first-documented ST-segment elevation acute myocardial infarction (AMI).~   "
266265|NCT00078000|"~     Assessment of safety and efficacy of SU11248 in patients with metastatic breast cancer who~     have failed selected other therapies.~   "
266266|NCT00077987|"~     Assessment of safety and efficacy of SU11248 in patients with metastatic colorectal cancer~     who have failed selected previous treatments.~   "
266267|NCT00077974|"~     To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal~     cell carcinoma~   "
266268|NCT00077961|"~     The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used~     in combination with rituximab for patients with relapsing or refractory, low-grade or~     follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary~     objective of phase I, while the primary objective of phase II will be to determine overall~     response.~   "
266269|NCT00077948|"~     Beta-blocker medications have been shown to improve heart function and prolong the lives of~     patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty~     taking beta-blocker medications due to troublesome side effects, such as low blood pressure~     and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words,~     they have difficulty tolerating beta-blocker medications. The purpose of this study is to~     determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.~   "
266270|NCT00077935|"~     The purpose of this study is to evaluate the safety of Civamide Cream 0.075% as a Treatment~     in Subjects with Osteoarthritis (OA) of the Knee(s).~   "
266271|NCT00077844|"~     The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin~     versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as~     assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and~     minor bleeding.~   "
266272|NCT00077883|"~     The purpose of this trial is to study the efficacy and safety of the combination of TLK286~     with cisplatin as first-line therapy for patients with locally advanced or metastatic~     non-small cell lung cancer.~   "
266273|NCT00077870|"~     This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and~     subject-blinded study of the safety of escalating doses of ocrelizumab in combination with~     MTX in subjects with moderate to severe RA~   "
266274|NCT00077857|"~     This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to~     that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced~     or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients~     were randomized to receive either 1250 mg/m^2 or 825 mg/m^2 orally twice a day (po bid) on~     days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on~     day 1 of each 3 week cycle. The anticipated time on study treatment was until disease~     progression and the target sample size was 440 individuals.~   "
266275|NCT00077831|"~     To learn more about the cognitive and motor development of infants and young children born~     with a craniofacial defect called craniosynostosis.~   "
266276|NCT00077818|"~     The purpose of this study is to determine the efficacy and safety of enoxaparin compared to~     unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the~     emergency department (ED). Efficacy is assessed by using a composite score consisting of~     30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina~     requiring revascularization.~   "
266277|NCT00077805|"~     Primary objective:~        -  To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared~          to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following~          acute ischemic stroke.~      Secondary objectives:~        -  To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days~          from the time of randomization~        -  To compare neurologic outcomes between the 2 treatment groups, including incidence of~          stroke recurrence, rate of stroke progression, and patient functional status, during the~          10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization~        -  To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in~          patients following acute ischemic stroke~   "
266278|NCT00077792|"~     The primary objective of the study is to determine whether enoxaparin compared to~     unfractionated heparin will reduce the composite endpoint of all-cause mortality and~     non-fatal myocardial re-infarction within 30 days after randomization in patients with acute~     ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy~   "
266279|NCT00077779|"~     The purpose of this study is to test whether Adalimumab (at two different doses) can induce~     and maintain clinical remission in subjects with active Crohn's disease when compared to~     placebo (a substance containing no medication)~   "
266280|NCT00077766|"~     This study will assess the efficacy and safety of intravenous (iv) Mircera given as~     maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who~     were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2~     years and the target sample size is 100-500 individuals.~   "
266281|NCT00077753|"~     Primary objective:~        -  To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd~          for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment~          with enoxaparin 40mg sc qd~      Secondary objectives:~        -  To assess the reduction in mortality rate at the end of the double-blind treatment~          period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to~          the study, in patients on extended prophylaxis~        -  To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization~          to the study~        -  To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical~          patients with prolonged immobilization. Safety evaluation includes:~             -  Major and minor hemorrhage~             -  Heparin induced thrombocytopenia~             -  Serious adverse events~        -  To assess differences in levels of health-care utilization and cost between patients~          receiving extended VTE prophylaxis versus those receiving placebo.~   "
266286|NCT00027924|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune~     cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the~     transplanted cells are rejected by the body's normal tissues. Drugs such as cyclosporine may~     prevent this from happening.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation in treating patients who have chronic myelogenous~     leukemia or myelodysplastic syndrome.~   "
266287|NCT00023647|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing~     the vaccine directly into a lymph node may cause a stronger immune response and kill more~     tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given directly into a~     lymph node in treating patients who have stage IV melanoma.~   "
266288|NCT00021294|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Eflornithine with or without triamcinolone may be~     effective in preventing nonmelanoma skin cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or~     without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic~     keratosis.~   "
266289|NCT00021034|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of taurolidine in treating patients who~     have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal~     cancer.~   "
266290|NCT00021021|"~     RATIONALE: RPI.4610 may stop the growth of metastatic kidney cancer by stopping blood flow to~     the tumor.~      PURPOSE: Phase II trial to study the effectiveness of RPI.4610 in treating patients who have~     metastatic kidney cancer.~   "
266291|NCT00020917|"~     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cetuximab with combination~     chemotherapy in treating patients who have stage IV colorectal cancer.~   "
266292|NCT00020553|"~     RATIONALE: A videotape support program may help families improve communication and coping~     skills when a parent is diagnosed with cancer.~      PURPOSE: Randomized trial to study the effectiveness of a video support program for families~     who have a parent who has been newly diagnosed with cancer.~   "
266293|NCT00017459|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if cisplatin and vinorelbine are more effective~     with or without tirapazamine in treating non-small cell lung cancer~      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus~     vinorelbine with or without tirapazamine in treating patients who have stage IIIB or stage IV~     non-small cell lung cancer.~   "
266294|NCT00017199|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have~     metastatic neuroendocrine tumors.~   "
266295|NCT00017056|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who~     have recurrent metastatic stomach cancer that has been previously treated with chemotherapy.~   "
266296|NCT00016172|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combining ZD0473 and doxorubicin in~     treating patients who have advanced solid tumors or lymphoma.~   "
266297|NCT00014625|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have~     stage IV melanoma.~   "
266298|NCT00014430|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells.~      PURPOSE: Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating~     patients who have refractory or metastatic breast cancer.~   "
266299|NCT00008281|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which regimen of chemotherapy is more effective~     for metastatic colorectal cancer.~      PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in~     treating patients who have metastatic colorectal cancer.~   "
266300|NCT00007878|"~     This phase I trial studies the side effects and best dose of bortezomib when given together~     with fluorouracil and leucovorin calcium in treating patients with solid tumors that are~     metastatic or cannot be removed by surgery. Bortezomib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     fluorouracil and leucovorin calcium, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving bortezomib~     together with chemotherapy may be an effective treatment for solid tumors.~   "
266301|NCT00006122|"~     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     Drugs used in chemotherapy uses different ways to stop cancer cells from dividing so they~     stop growing or die. Combining gemtuzumab ozogamicin with chemotherapy may kill more cancer~     cells.~      PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin with or without~     chemotherapy in treating older patients who have acute myeloid leukemia.~   "
266302|NCT00005795|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have acute myeloid leukemia.~   "
266304|NCT00005631|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer~     cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy~     in treating patients who have relapsed or refractory large cell lymphoma.~   "
266305|NCT00005609|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have~     Waldenstrom's macroglobulinemia.~   "
266306|NCT00005089|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer~     cells and either kill them or deliver cancer-killing substances to them without harming~     normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining~     chemotherapy with monoclonal antibody therapy and radiation therapy may kill more cancer~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab~     and radiation therapy in treating patients who have stage I or stage II non-Hodgkin's~     lymphoma.~   "
266307|NCT00004152|"~     RATIONALE: Diagnostic procedures may improve the ability to detect metastatic melanoma and to~     determine the extent of disease.~      PURPOSE: Phase II trial to evaluate the effectiveness of PET and CT scans to detect~     metastatic disease in patients who have stage III or stage IV melanoma.~   "
266308|NCT00004145|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Sometimes the transplanted cells are rejected by the body's normal tissues. Antithymocyte~     globulin may prevent this from happening.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus biological therapy~     followed by peripheral stem cell transplantation in treating patients who have hematologic~     cancer.~   "
266309|NCT00004114|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may be able to replace~     immune cells that were destroyed by chemotherapy used to kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell~     transplantation in treating patients who have advanced hematologic cancer.~   "
266310|NCT00003916|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an~     effective treatment for patients with glioma. Stereotactic radiation therapy may be able to~     deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet~     known if standard radiation therapy is more effective when followed by stereotactic radiation~     therapy.~      PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation~     therapy with or without stereotactic radiation therapy in treating patients who have glioma.~   "
266311|NCT00003867|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating~     patients who have solid tumors that have not responded to previous treatment.~   "
266312|NCT00003632|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients with newly diagnosed CNS lymphoma.~   "
266313|NCT00003582|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side~     effects of radiation therapy and chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination~     chemotherapy and amifostine in treating patients who have stage II, stage III, or stage IV~     head and neck cancer that cannot be surgically removed.~   "
266314|NCT00003545|"~     Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or~     relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die.~   "
266315|NCT00003207|"~     The rationale for conducting this study lies in the premise that if indeed the reason for a~     limited response of Kaposi's sarcoma lesions and other advanced malignancies to chemotherapy~     is attributable to a high expression of P-glycoprotein, then, by inhibiting this pump, tumor~     kill would be enhanced and response rates as well as duration of responses would also~     increase. Doxil is chosen since recent studies have shown that it is superior to combination~     chemotherapy with ABV or BV. Doxil is also known to be active in other malignancies such as~     breast and ovarian cancer (34,35). PSC 833 is chosen since it has been found to reverse P-gp~     in vitro and in vivo, is non-immunosuppressive, and has been shown in recent Phase 1 studies~     to be well tolerated.~      There are yet no human studies reported on Doxil pharmacokinetics when combined with MDR~     modulators. Preclinical data shows that pharmacokinetics of Doxil, unlike free doxorubicin,~     is minimally affected by the addition of PSC 833 (36). Enhanced tumor toxicity was observed~     when PSC 833 was combined with Doxil. Since doxorubicin, the active agent in Doxil, is~     metabolized by the same cytochrome P450, interactions between these 2 agents may have very~     significant clinical implications. The purpose of this study is to assess the toxicity and~     determine the maximum tolerated dose of Doxil when combined with PSC 833 in the treatment of~     AIDS-KS and other advanced malignancies.~   "
266338|NCT00077493|"~     RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal~     cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute~     lymphoblastic leukemia and non-Hodgkin's lymphoma.~      PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in~     treating young patients with relapsed or refractory acute lymphoblastic leukemia or~     non-Hodgkin's lymphoma.~   "
266316|NCT00003150|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. It is not yet known if combination chemotherapy is more effective with or without~     rituximab for non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without rituximab in treating older patients who have non-Hodgkin's lymphoma.~   "
266317|NCT00003066|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel combined with estramustine in~     treating women with metastatic breast cancer.~   "
266318|NCT00003062|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effect of temozolomide in patients with progressive or~     recurrent stage IV non-small cell lung cancer, with or without brain metastases, who have not~     been treated for metastatic disease with chemotherapy.~   "
266319|NCT00003011|"~     RATIONALE: Marimastat may stop the growth of lung cancer by stopping blood flow to the tumor.~     It is not yet known if marimastat is an effective treatment for small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of marimastat with a placebo~     following chemotherapy in treating patients who have small cell lung cancer.~   "
266320|NCT00002869|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Low doses of~     interferon alfa may be as effective as high doses.~      PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose or high-dose~     interferon alfa in treating patients who have newly diagnosed chronic myelogenous leukemia.~   "
266321|NCT00002868|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining interferon alfa with high-dose chemotherapy and peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or~     without peripheral stem cell transplantation in treating patients who have newly diagnosed~     chronic myelogenous leukemia in chronic phase.~   "
266322|NCT00002532|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have relapsed or refractory acute lymphocytic leukemia.~   "
266323|NCT00002531|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of various combination~     chemotherapy regimens in treating patients with acute lymphocytic leukemia.~   "
266324|NCT00077922|"~     This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating~     chronic lymphocytic leukemia (CLL) in patients who have a protein called cluster of~     differentiation 25 (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. It is~     made up of two parts: a genetically engineered monoclonal antibody that binds to cancer cells~     with CD25 on their surface, and a toxin produced by bacteria that kills the cancer cells to~     which it binds. LMB-2 has killed CD 25-containing cells in laboratory experiments and has~     caused tumors in mice to shrink. Preliminary studies in humans have shown some effectiveness~     in shrinking tumors in patients with various types of lymph and blood cancers.~      Patients 18 years of age and older with CLL who have CD25 receptor proteins on their cancer~     cells and whose disease has progressed within 2 years of treatment with fludarabine may be~     eligible for this study. Candidates are screened with a medical history and physical~     examination, blood and urine tests, electrocardiogram (EKG), echocardiogram, chest x-ray,~     computed tomography (CT) scans of the chest, abdomen and pelvis, and a bone marrow biopsy.~      Participants receive up to six cycles of LMB-2 therapy. Each 28-day cycle consists of~     30-minute infusions of LMB-2 on cycle days 1, 3, and 5. The drug is infused through an~     intravenous (IV) catheter (plastic tube placed in a vein) or a central venous line-an IV tube~     placed in a large vein in the neck or chest that leads to the heart. Patients are admitted to~     the National Institutes of Health (NIH) Clinical Center for the first treatment cycle. If the~     infusion is well tolerated, subsequent cycles may be given on an outpatient basis. In~     addition to drug therapy, patients undergo the following procedures:~        -  Blood draws: Blood is drawn before, during, and after each LMB-2 infusion to measure~          blood levels of the drug, evaluate its effects on the cancer cells, and monitor side~          effects. Blood tests are also done before and during each cycle to determine how the~          immune system is interacting with the drug.~        -  Disease evaluations: Patients undergo a physical examination, blood tests, chest x-ray,~          and EKG before each treatment cycle and at follow-up visits. With the patient's~          permission, CT scans, echocardiogram, and bone marrow biopsies may be repeated before~          some treatment cycles if these tests prove useful in evaluating the disease response to~          LMB-2.~      Patients may receive up to six cycles of LMB-2 as long as their cancer does not worsen and~     they do not develop serious side effects. At the end of the treatment cycles, patients will~     have blood tests done weekly by their local physician, and the results will be sent to the~     NCI study investigators.~   "
266325|NCT00077909|"~     This study will examine the different types of proteins present in the lungs of patients with~     pneumonia to explore the causes of different types of the disease. Pneumonia is a condition~     that causes lung inflammation AND is often caused by an infection. It is usually diagnosed by~     lung x-rays and listening to the chest with a stethoscope. This method can diagnose~     pneumonia, but it does not provide information on the cause of the inflammation - information~     that might be helpful in guiding treatment. This study will measure proteins in the lungs of~     patients to see if certain proteins are associated with specific forms of pneumonia, and can~     thus serve as biomarkers for disease.~      Patients undergoing diagnostic bronchoscopy at the NIH Clinical Center may participate in~     this study. Patients will undergo bronchoscopy and bronchoalveolar lavage as scheduled for~     their medical care. For this procedure, the patient's mouth and throat are numbed with~     lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is~     advanced through the nose or mouth into the lung airways to examine the airways carefully.~     Saline (salt water) is then injected through the bronchoscope into the air passage, acting as~     a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the~     current study will use some of the fluid obtained from the lavage to examine for protein~     content.~      In addition to the bronchoscopy and bronchoalveolar lavage, participants will have about 2~     tablespoons of blood drawn to compare blood test results with the results of the lung~     washings. Patients' medical records will be reviewed to obtain information on past medical~     history, current medical treatment, vital signs, and results of x-ray tests.~   "
266339|NCT00077467|"~     This phase I trial is studying the side effects and best dose of bortezomib in treating young~     patients with refractory or recurrent leukemia. Bortezomib may stop the growth of cancer~     cells by blocking the enzymes necessary for their growth.~   "
266326|NCT00077896|"~     This pilot study will evaluate the effect of direct current (DC) electrical polarization of~     the brain on language, memory, reaction time, and mood in six patients with frontotemporal~     dementia (Pick's disease). There is no effective treatment available for cognitive impairment~     in patients with this condition. DC polarization sends a very weak current between two sponge~     pads placed on the head. In a previous study in healthy volunteers, DC polarization of the~     left prefrontal area of the brain increased verbal fluency, memory and attention, and motor~     reaction time in the study subjects.~      Patients between 35 and 75 years of age with frontotemporal dementia who have been referred~     to NINDS's Cognitive Neuroscience Section for an existing protocol will be offered~     participation in this study. Candidates will be screened with a neurological examination to~     confirm the diagnosis of frontotemporal dementia.~      Participants receive 40 minutes of DC polarization or sham polarization in each of two~     separate sessions. (No current is applied in the sham treatment). During the polarization,~     the patient rests quietly. Sponge pads that have been soaked in water are put on the left~     side of the head and above the right eye, and are held in place with elastic netting. Before~     the polarization and after about 20 minutes of polarization, patients undergo the following~     tests:~        -  Language: Patients must say as many words beginning with certain letters as they can in~          90 seconds.~        -  Memory: Patients must remember a letter on a computer screen, and when the letter~          appears again, press the same letter on the keyboard.~        -  Reaction time: Patients place pegs on a pegboard.~        -  Mood: Patients place a mark on a line ranking how they feel.~   "
266327|NCT00077675|"~     Serious infections caused by resistant bacteria are becoming more of a medical problem~     throughout the world. This study will measure how well TD-6424 (Telavancin) can control~     infections and whether the drug is safe to give to patients.~   "
266328|NCT00077649|"~     The effects of treatment with different doses of PEGASYS in combination with different doses~     of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer,~     body weight greater than 85kg (187lbs) and no prior treatment with interferon. The~     anticipated time on study treatment is 3-12 months and the target sample size is 100-500~     individuals.~   "
266329|NCT00077636|"~     This study will evaluate the efficacy and safety of different durations of treatment with~     PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never~     previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12~     months and the target sample size is 500+ individuals.~   "
266330|NCT00077623|"~     This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as~     maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who~     were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years~     and the target sample size is 100-500 individuals.~   "
266331|NCT00077610|"~     This study will assess the efficacy and safety of intravenous Mircera, given as maintenance~     treatment for renal anemia in chronic kidney disease patients on dialysis who were previously~     receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target~     sample size is 100-500 individuals.~   "
266332|NCT00077662|"~     Pompe disease (also known as glycogen storage disease type II, GSD-II) is caused by a~     deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally,~     GAA is used by the body's cells to break down glycogen (a stored form of sugar) within~     specialized structures called lysosomes. In patients with Pompe disease, an excessive amount~     of glycogen accumulates and is stored in various tissues, especially heart and skeletal~     muscle, which prevents their normal function.~      This study is being conducted to collect prospective, observational data on patients with~     late-onset Pompe disease. Approximately 60 subjects with late-onset Pompe disease will be~     enrolled.~   "
266333|NCT00077597|"~     This study will assess the efficacy and safety of Mircera given intravenously in the~     treatment of renal anemia in chronic kidney disease patients on dialysis who are not~     currently receiving epoetin or any other erythropoietic substance. The anticipated time on~     study treatment is 1-2 years and the target sample size is 100-500 individuals.~   "
266334|NCT00077558|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop~     cancer cells from dividing so they stop growing or die. 3-AP may help fludarabine kill more~     cancer cells by making them more sensitive to the drug.~      PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when~     given together with 3-AP in treating patients with relapsed or refractory acute leukemia,~     chronic leukemia, or high-risk myelodysplastic syndrome.~   "
266335|NCT00077545|"~     Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor~     cells from dividing so they stop growing or die. 3-AP may help cisplatin kill more cancer~     cells by making them more sensitive to the drug. This phase II trial is studying how well~     giving 3-AP together with cisplatin works in treating patients with recurrent or metastatic~     adenocarcinoma of the esophagus or gastroesophageal junction.~   "
266336|NCT00077532|"~     RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the~     immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make~     the body build an immune response to kill tumor cells. Combining the vaccines with Montanide~     ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known~     whether monoclonal antibody therapy is more effective with or without vaccine therapy in~     treating advanced melanoma.~      PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see~     how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide~     ISA-51 in treating patients with stage IV melanoma.~   "
266337|NCT00077519|"~     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth and may make them more sensitive to radiation therapy. Radiation therapy~     uses high-energy x-rays to damage tumor cells. Giving tipifarnib together with radiation~     therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when~     given together with radiation therapy in treating patients with unresectable locally advanced~     pancreatic cancer.~   "
266355|NCT00006388|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     tamoxifen may make the tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with~     tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma~     multiforme.~   "
266340|NCT00077454|"~     This phase I trial is studying the side effects and best dose of erlotinib when given with~     temozolomide in treating young patients with recurrent or refractory solid tumors. Erlotinib~     may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs~     used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from~     dividing so they stop growing or die. Giving erlotinib with temozolomide may kill more tumor~     cells.~   "
266341|NCT00077441|"~     This phase II trial is studying how well bortezomib works in treating patients with~     hepatocellular carcinoma (liver cancer) that cannot be removed with surgery. Bortezomib may~     stop the growth of tumor cells by blocking the enzymes necessary for their growth.~   "
266342|NCT00077428|"~     This phase II trial is studying how well bortezomib followed by doxorubicin at the time of~     disease progression works in treating patients with locally advanced, recurrent, or~     metastatic adenoid cystic carcinoma (cancer) of the head and neck. Bortezomib may stop the~     growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in~     chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing~     so they stop growing or die. Combining bortezomib with doxorubicin may kill more tumor cells~   "
266343|NCT00077415|"~     RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways~     to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine as~     second-line therapy works in treating patients with recurrent stage III or stage IV non-small~     cell lung cancer.~   "
266344|NCT00077402|"~     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well fenretinide works in treating patients with~     advanced or metastatic hormone-refractory prostate cancer.~   "
266345|NCT00077389|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the~     tumor so that it can be removed.~      PURPOSE: This phase II trial is studying how well neoadjuvant chemotherapy works in treating~     young patients who are undergoing surgical resection for high-risk hepatoblastoma.~   "
266346|NCT00077376|"~     This phase II trial is studying how well giving trastuzumab together with ixabepilone and~     carboplatin works in treating patients with HER2/neu-positive metastatic breast cancer.~     Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy, such as ixabepilone and carboplatin, work in different ways to stop tumor cells~     from dividing so they stop growing or die. Combining trastuzumab with ixabepilone and~     carboplatin may kill more tumor cells.~   "
266347|NCT00077363|"~     This phase II trial is studying how well giving capecitabine together with tipifarnib works~     in treating women with taxane-resistant metastatic breast cancer. Drugs used in chemotherapy,~     such as capecitabine, work in different ways to stop tumor cells from dividing so they stop~     growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes~     necessary for their growth. Giving capecitabine together with tipifarnib may kill more tumor~     cells~   "
266348|NCT00077350|"~     Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Giving 3-AP together with gemcitabine~     may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with~     gemcitabine works as second-line therapy in treating patients with progressive or recurrent~     non-small cell lung cancer~   "
266349|NCT00077337|"~     RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with~     unresectable locally advanced or metastatic colorectal cancer.~   "
266350|NCT00077324|"~     RATIONALE: Evaluating specific proteins in the blood may be an effective and noninvasive~     procedure to help doctors determine if a patient has early non-small cell lung cancer.~      PURPOSE: This clinical trial is studying proteomic profiling to see how well it works in~     diagnosing non-small cell lung cancer in patients who are undergoing resection for suspicious~     (abnormal) stage I lung lesions.~   "
266351|NCT00077311|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs,~     such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and~     inner ear damage) caused by chemotherapy.~      PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together~     with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in~     treating patients with stage IIIB or stage IV non-small cell lung cancer.~   "
266352|NCT00007852|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy~     followed by bone marrow or peripheral stem cell transplantation in treating patients who have~     relapsed or refractory non-Hodgkin's lymphoma.~   "
266353|NCT00006786|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping~     blood flow to the tumor.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     bevacizumab in treating patients who have advanced colorectal cancer.~   "
266354|NCT00006459|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if paclitaxel is more effective with or without gemcitabine for advanced breast~     cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel with or without~     gemcitabine in treating women who have advanced breast cancer.~   "
266357|NCT00006123|"~     RATIONALE: Chemotherapy uses different ways to stop tumor cells from dividing so they stop~     growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow~     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal~     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and peripheral stem cell~     transplantation followed by trastuzumab in treating women who have metastatic breast cancer.~   "
266358|NCT00006047|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of nitrocamptothecin plus etoposide in~     treating patients who have advanced solid tumors.~   "
266359|NCT00006038|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     surgery and intraperitoneal chemotherapy in treating patients who have locally advanced~     stomach cancer.~   "
266360|NCT00005995|"~     RATIONALE: AE-941 may stop the growth of kidney cancer by stopping blood flow to the tumor.~      PURPOSE: Randomized phase III trial to determine the effectiveness of AE-941 in treating~     patients who have metastatic kidney cancer that has not responded to biological therapy.~   "
266361|NCT00005986|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Colony-stimulating factors such as filgrastim may increase the number of immune cells found~     in bone marrow or peripheral blood and may help a person's immune system recover from the~     side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy and filgrastim followed by~     peripheral stem cell transplantation in treating patients who have chronic myelogenous~     leukemia.~   "
266362|NCT00005877|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have advanced or recurrent colorectal cancer.~   "
266363|NCT00005862|"~     Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced,~     metastatic, or recurrent soft tissue sarcomas. SU5416 may stop the growth of soft tissue~     sarcomas by stopping blood flow to the tumor.~   "
266364|NCT00005610|"~     RATIONALE: Colony-stimulating factors, such as sargramostim, may help the body's immune~     system to kill cancer cells. Giving sargramostim in different ways may kill more cancer~     cells.~      PURPOSE: Phase II trial to study the effectiveness of sargramostim given as a breathing~     treatment for treating patients who have melanoma that is metastatic to the lung.~   "
266365|NCT00004919|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the~     side effects of chemotherapy. Phase I trial to study the effectiveness of irinotecan and~     cisplatin with or without amifostine in treating children who have solid tumors that have not~     responded to previous therapy.~   "
266366|NCT00004889|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have~     Waldenstrom's macroglobulinemia.~   "
266367|NCT00004203|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who~     have metastatic bladder cancer.~   "
266368|NCT00004157|"~     RATIONALE: Interleukin-11 and filgrastim stimulate the production of blood cells. Giving~     these drugs to stimulate peripheral stem cells that can be collected for peripheral stem cell~     transplantation may result in fewer side effects after transplant.~      PURPOSE: Phase II trial to study the effectiveness of interleukin-11 plus filgrastim prior to~     peripheral stem cell transplantation in patients who have non-Hodgkin's lymphoma, Hodgkin's~     disease, breast cancer, or other solid tumors.~   "
266369|NCT00004003|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     adult patients who have stage III or stage IV pancreatic cancer that cannot be removed by~     surgery.~   "
266370|NCT00077584|"~     In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without~     digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers~     versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and~     healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.~   "
266371|NCT00077298|"~     This randomized phase II trial is studying giving bevacizumab and cetuximab together with~     irinotecan to see how well it works compared to giving bevacizumab and cetuximab alone in~     treating patients with irinotecan-refractory metastatic colorectal cancer. Monoclonal~     antibodies such as cetuximab and bevacizumab can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or deliver tumor -killing substances to them. Drugs used in chemotherapy, such as~     irinotecan, also work in different ways to kill tumor cells or stop them from growing. Giving~     cetuximab and bevacizumab together with irinotecan may improve the ability to block tumor~     growth.~   "
266372|NCT00077285|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin~     as upfront window therapy (first-line therapy) works in treating patients with newly~     diagnosed intermediate-risk or high-risk rhabdomyosarcoma.~   "
270399|NCT00001427|"~     The objectives of this study are to determine the response rate to 9-AC in patients with~     advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based~     chemotherapy regimens.~   "
266373|NCT00077259|"~     RATIONALE: Drugs used in chemotherapy such as epothilone D work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well epothilone D works as second-line therapy~     in treating patients with advanced or metastatic refractory colorectal cancer.~   "
266374|NCT00077246|"~     RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of ABI-007 and to~     see how well it works in treating patients with stage IV non-small cell lung cancer.~   "
266375|NCT00077233|"~     This is a randomized phase II study trial that has served as a screening trial to test the~     increased efficacy of chemotherapy + cetuximab versus chemotherapy alone among patients with~     untreated, advanced or metastatic colon cancer regardless of tumor status with respect to~     EGFR.~   "
266376|NCT00077220|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. It is not yet known whether giving chemotherapy~     together with radiation therapy is more effective with or without adjuvant chemotherapy in~     treating unresectable stage II or stage III non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and~     radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works~     compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients~     with unresectable stage II or stage III non-small cell lung cancer.~   "
266377|NCT00077207|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide,~     work in different ways to stop tumor cells from dividing so they stop growing or die. Giving~     more than one drug may kill more tumor cells.~      PURPOSE: This pilot study is studying giving carboplatin and vincristine together with~     temozolomide in treating children with progressive and/or symptomatic low-grade glioma.~   "
266378|NCT00077194|"~     This phase II trial is studying how well FR901228 works in treating patients with relapsed or~     refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as FR901228, work in~     different ways to stop tumor cells from dividing so they stop growing or die.~   "
266379|NCT00077181|"~     Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells~     from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by~     making them more sensitive to the drug. This phase I trial is studying the side effects and~     best dose of 3-AP when given with high-dose cytarabine in treating patients with advanced~     hematologic malignancies~   "
266380|NCT00077168|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known whether radiation therapy after surgery is effective in preventing a recurrence of~     ductal carcinoma in situ.~      PURPOSE: This randomized phase II trial is studying adjuvant radiation therapy to see how~     well it works compared to observation after surgery in treating women with estrogen receptor~     positive or progesterone receptor positive ductal carcinoma in situ and are also receiving~     either tamoxifen or anastrozole.~   "
266381|NCT00077155|"~     This phase I trial is studying the side effects and best dose of EMD 121974 in treating~     patients with solid tumors or lymphoma. Cilengitide (EMD 121974) may stop the growth of~     cancer cells by stopping blood flow to the cancer~   "
266382|NCT00077142|"~     RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of TAC-101 and to~     see how well it works in treating patients with advanced hepatocellular carcinoma (liver~     cancer).~   "
266383|NCT00077129|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin~     works in treating patients with locally advanced or metastatic collecting duct renal cell~     cancer that cannot be removed by surgery.~   "
266384|NCT00077116|"~     RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different~     ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies,~     such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Giving monoclonal antibody~     therapy together with chemotherapy may kill more cancer cells. Giving healthy stem cells from~     a donor whose blood closely resembles the patient's blood will help the patient's bone marrow~     make new stem cells that become red blood cells, white blood cells, and platelets.~      PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together~     with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk~     myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome.~   "
266385|NCT00077103|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cisplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Combretastatin A4 phosphate may stop the growth of~     cancer by stopping blood flow to the tumor. Combining doxorubicin and cisplatin with~     radiation therapy and combretastatin A4 phosphate may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving induction chemotherapy using~     doxorubicin and cisplatin together with radiation therapy and combretastatin A4 phosphate~     works in treating patients with newly diagnosed regionally advanced anaplastic thyroid~     cancer.~   "
266386|NCT00077090|"~     RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and~     reducing lymphedema caused by radiation therapy for cancer.~      PURPOSE: This randomized phase II trial is studying hyperbaric oxygen to see how well it~     works compared to standard therapy in treating chronic arm lymphedema in patients who have~     undergone radiation therapy for cancer.~   "
266387|NCT00077077|"~     RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, use different ways to~     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may~     kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of DJ-927 and~     capecitabine in treating patients with locally advanced or metastatic solid tumors.~   "
266388|NCT00077064|"~     RATIONALE: Captopril is a drug that may be able to decrease side effects caused by radiation~     therapy, and may improve the quality of life of patients with non-small cell lung cancer or~     limited-stage small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying how well captopril works in decreasing~     side effects and improving the quality of life in patients who have received radiation~     therapy with or without chemotherapy for stage I, stage II, or stage IIIB non-small cell lung~     cancer or limited-stage small cell lung cancer.~   "
266389|NCT00077051|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosensitizing~     drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to~     radiation therapy. Drugs used in chemotherapy, such as cisplatin work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Combining radiosensitizers with chemotherapy and radiation therapy may kill more~     tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when~     given together with tetrahydrouridine, cisplatin and radiation therapy in treating patients~     with advanced squamous cell carcinoma of the oral cavity (mouth) or oropharynx (throat).~   "
266390|NCT00077025|"~     This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with~     Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of~     metastatic breast cancer.~   "
266391|NCT00077012|"~     The primary objective of this study is to assess the safety and tolerance of transurethral~     photodynamic therapy (PDT) with QLT0074.~      Secondary objectives are:~        1. To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign~          prostatic hyperplasia (BPH), evaluated by the American Urological Association Symptom~          Index (AUA SI), urinary flow rate (Qmax), and post-void residual volume (PVR).~        2. To determine the extent of systemic exposure to QLT0074 following transurethral~          intraprostatic injection.~        3. To select up to two transurethral PDT drug-light regimens for further clinical~          development.~   "
266392|NCT00077038|"~     This study will examine how the brain works when people look at an object, follow a moving~     object with their eyes, and reach out their hand to an object. Different areas of the brain~     work together in reaching out a hand to an object. These areas are also important for~     concentrating on objects or following them with the eyes. This study will use~     magnetoencephalography (MEG) to observe more precisely how discrete parts of the brain work~     during these movements. MEG is a new technique for recording magnetic field changes produced~     by brain activity.~      Healthy normal volunteers 20 years of age and older who are right-handed and who have no~     history of brain or eye disease may be eligible for this study. Candidates will be screened~     with a medical history and brief physical examination. They will complete questionnaires for~     MEG screening and for determining handedness.~      Participants undergo MEG recording and magnetic resonance imaging (MRI). For MEG, the subject~     sits comfortably in front of a computer screen, and a cone containing magnetic field~     detectors is lowered onto the head. Electrodes are placed on both sides of the outer part of~     the eyelids and just above and below the left eye to monitor eye movement. During MEG,~     subjects perform the following tasks:~        1. Eye fixation: A small white cross and a white ring appear on the center of the computer~          screen. Another white ring moves slowly around the screen in random fashion. Subjects~          keep their eyes fixed on the central cross and concentrate on the ring at the center,~          ignoring the moving ring.~        2. Ocular tracking: The same cross and rings in task 1 appear on the screen, but in this~          task the subjects follow the moving ring with their eyes and ignore the cross and ring~          in the center.~        3. Peripheral manual tracking task (right hand): In addition to the cross and rings in task~          1, a small white disc-shaped cursor appears on the screen. Using their right hand,~          subjects use a joystick to move the cursor as precisely as possible to follow the moving~          ring, while keeping their eyes fixed on the central cross.~        4. Peripheral manual tracking task (left hand): The same as task 3, except using the left~          hand.~        5. Central manual tracking: The cross, rings, and joystick are the same as in task 3.~          Subjects move the cursor to follow the moving ring as precisely as possible, while~          following the moving ring with their eyes and ignoring the cross and ring in the center~          of the screen.~      Subjects practice each task before MEG recording starts. Then they perform each task twice in~     random order, with a 1- or 2-minute break between tasks.~      Subjects who do not have previous MRI images filed in NINDS's database undergo MRI scanning.~     MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues.~     The scanner is a metal cylinder surrounded by a strong magnetic field. Subjects lie still on~     a table that can slide in an out of the cylinder. They can communicate with the MRI staff at~     all times during the procedure.~   "
266393|NCT00076999|"~     The primary objective of this study is to assess the safety and tolerability of tipranavir~     (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in~     HIV-infected children and adolescents, to provide information concerning the pharmacokinetic~     characteristics of tipranavir and ritonavir in this age group, and to determine the relative~     bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents~     switching from liquid to capsule.~      The secondary objective of this study is the determination of the dose of topranavir and~     ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an~     adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.~   "
266394|NCT00076986|"~     The purpose of the PRECISE trial is to determine whether overall survival duration, safety,~     and quality of life are improved for patients treated with IL13-PE38QQR compared to patients~     treated with GLIADEL® Wafer following surgical tumor removal in the treatment of first~     recurrence of glioblastoma multiforme.~   "
266395|NCT00076960|"~     The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin]~     available to infants who meet the following criteria:~        1. the infant has a very high level of bilirubin without an adequate clinical response to~          phototherapy;~        2. the infant requires an exchange transfusion; and~        3. the family refuses to allow the administration of blood products, particularly on~          religious grounds, such as within the Jehovah's Witness community.~   "
266396|NCT00076947|"~     The purpose of this study is to determine the safety of a new HIV vaccine. The vaccine in~     this study is mixed with a chemical called alum to improve the body's response to the~     vaccine. Healthy adults who are not infected with HIV may participate in the study.~   "
266397|NCT00076934|"~     Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune system~     attacks and destroys the cells that cover and protect nerves. This study will test the safety~     of a new drug called RG2077 that is designed to treat MS. The study will not determine~     whether RG2077 is effective in treating MS, only whether it is safe to use in patients with~     MS.~      Study hypothesis: RG2077 will arrest MS if administered early in the course of MS and~     decrease accumulation of lesions on MRI.~   "
266398|NCT00076921|"~     To characterize the development of tobacco control capacity with staff from the Chinese~     Center's for Disease control (CDCs) at the provincial level and to have them develop and~     implement population-level interventions to build awareness and knowledge concerning the~     harms of smoking that could help lead to policy action being taken to protect the population~     from the harms caused by smoking. Compare capacity, policy and, second-hand smoke exposure~     and smoking rates in selected provinces to national levels.~   "
266469|NCT00003882|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of anhydrovinblastine in treating patients~     who have advanced recurrent solid tumors.~   "
266399|NCT00003937|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~     Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of~     chemotherapy.~      PURPOSE: Phase III trial to study the effectiveness of three combination chemotherapy~     regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic~     osteosarcoma.~   "
266400|NCT00003923|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill tumor cells. This may be effective treatment for cancer of the bile duct,~     gallbladder, or pancreas.~      PURPOSE: Phase II trial to determine the effectiveness of photodynamic therapy in treating~     patients who have cancer of the bile duct, gallbladder, or pancreas.~   "
266401|NCT00003721|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of COL-3 in treating patients who have~     advanced solid tumors.~   "
266402|NCT00003665|"~     Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients~     who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor~     cells.~   "
266403|NCT00003616|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients who~     have progressive or recurrent malignant glioma.~   "
266404|NCT00003370|"~     Phase I trial to study the effectiveness of irofulven in treating children with recurrent or~     refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells so~     they stop growing or die.~   "
266405|NCT00003367|"~     RATIONALE: The amount of fat, fiber, soy, fruits, vegetables, vitamin E, and green tea in the~     diet may affect androgen metabolism in men. This may affect PSA level in patients with~     prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two diets, differing in~     fat, fiber, soy, fruit, vegetable, vitamin E, and green tea content, in affecting PSA level~     in patients with prostate cancer.~   "
266406|NCT00003334|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and paclitaxel in~     treating patients who have recurrent or refractory endometrial cancer, fallopian tube cancer,~     or sarcoma of the female reproductive tract.~   "
266407|NCT00003222|"~     RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to~     and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of~     immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a~     person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and~     interleukin-2 may be kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with~     or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV~     melanoma.~   "
266408|NCT00003185|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing.~      PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients~     with glioblastoma multiforme.~   "
266409|NCT00003108|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of cisplatin plus bryostatin 1 in treating~     patients who have advanced cancer.~   "
266410|NCT00003086|"~     RATIONALE: Bone marrow transplantation may allow the doctor to give higher doses of~     chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose~     chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have~     stage IV breast cancer.~   "
266411|NCT00076869|"~     Invasive aspergillosis is a type of fungal infection typically identified in very sick~     patients (for example, patients with cancer or who have had a bone marrow or organ~     transplant). This study will seek to enroll patients (16 years of age or older) with invasive~     aspergillosis infections (involving organs or deep tissues) who are failing or could not~     tolerate standard antifungal therapy. Your doctor will make this determination based upon~     specific study criteria. Patients that fulfill all study criteria will be treated daily with~     both the investigational drug and another antifungal agent. The choice of the other agent is~     up to your doctor. This investigational drug is approved for the treatment of invasive~     aspergillosis by itself. The safety and efficacy of this investigational drug, in combination~     with other agents is not known.~   "
266412|NCT00076856|"~     The purpose of this study is to demonstrate improvement in overall survival for the~     combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT~     alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS~     progression with the addition of TMZ to WBRT.~   "
266413|NCT00076817|"~     The purpose of this study is to determine the safety of and immune system response to the~     ALVAC-HIV (vCP205) vaccine when it is injected either into the groin area or into the arm.~     The goal is to determine if injecting the vaccine into the groin area produces a better~     immune response in the lining of the rectum.~   "
266414|NCT00076804|"~     Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These~     drug regimens must be closely followed in order to be successful. Having a support person~     watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her~     regimen. This study will see if patient-chosen treatment supporters help patients take HIV~     medicines correctly and improve their health.~      Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly~     higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm~     as compared to the self-administered arm.~   "
266415|NCT00076791|"~     Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal~     transmission) become infected during labor and delivery. The purpose of this study is to test~     the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or~     emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to~     their newborn infants.~   "
266416|NCT00033592|"~     RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop~     smoking and prevent them from starting smoking again. It is not yet known whether a nicotine~     inhaler or bupropion are more effective alone or combined for stopping smoking.~      PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or~     bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to~     stop smoking and prevent starting smoking again.~   "
266417|NCT00026377|"~     RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor.~     Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide,~     bicalutamide, leuprolide, or goserelin may fight prostate cancer by reducing the production~     of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining~     SU5416, hormone therapy, and radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of SU5416 plus hormone therapy and~     radiation therapy in treating patients who have prostate cancer.~   "
266418|NCT00024362|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BBR 3464 in treating patients who have~     locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.~   "
266419|NCT00024011|"~     Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic~     malignant melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die~   "
266420|NCT00003320|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     therapy after surgery to remove brain metastases may decrease the amount of radiation~     required to treat brain metastases.~      PURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to~     remove brain metastases.~   "
266421|NCT00003073|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of liposomal cytarabine in treating young~     patients who have recurrent or refractory meningeal leukemia, lymphoma, or solid tumors.~   "
266422|NCT00002801|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and combining radiation therapy with~     chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of~     fluorouracil-uracil and leucovorin plus radiation therapy in treating patients with~     colorectal cancer who have undergone surgery to remove the tumor.~   "
266423|NCT00002679|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose sequential chemotherapy as~     adjuvant therapy in treating patients with stage II or stage III breast cancer who have four~     or more positive axillary lymph nodes.~   "
266424|NCT00076843|"~     This study will examine the use of the humanized Mik-Beta-1 (Hu Mik-(SqrRoot) 1) monoclonal~     antibody in patients with HTLV-1-associated myelopathy/tropical spastic paraparesis~     (HAM/TSP). Some patients infected with the human T-lymphotropic virus type 1 (HTLV-1) virus~     develop HAM/TSP, a disease in which the immune response to HTLV-1 becomes directed against~     the person's own body in what is called an autoimmune response. Hu-Mik-Beta-1 is a~     genetically engineered antibody that blocks the action of a chemical produced by the body~     during infection or inflammation called interleukin 15 (IL-15). Blocking IL-15 may prevent~     the autoimmune response that results in HAM/TSP.~      Patients 18 years of age and older with HAM/TSP may be eligible for this study. Candidates~     are screened with a medical history and physical examination, blood and urine tests, and an~     electrocardiogram. Participants undergo the following procedures:~        1. Baseline visit(s): Repeat physical examination and blood and urine tests, as well as the~          following:~             -  Lumbar puncture: A local anesthetic is injected to numb the skin of the lower back.~               A needle is inserted in the space between the bones where the cerebrospinal fluid~               that bathes the brain and spinal cord circulates below the spinal cord. About 4~               tablespoons of fluid is collected through the needle.~             -  Magnetic resonance imaging (MRI): This test uses radio waves and magnets to produce~               images of body tissues and organs. The patient lies on a table that slides into a~               metal cylinder surrounded by a strong magnetic field. During part of the scan, a~               contrast agent is injected to brighten the images.~             -  Apheresis: This procedure is used to collect large quantities of white blood cells.~               Whole blood is collected through a needle in an arm vein and directed into a~               machine that separates it into its components by spinning. The white cells and~               plasma are removed and the rest of the blood (red cells and platelets) is returned~               to the body through the same needle.~        2. Hu Mik-Beta-1 treatment: Infusions of Hu Mik-Beta-1 are given through a vein every 3~          weeks for nine doses. The first treatment requires at least an overnight hospital stay;~          subsequent infusions are given in the outpatient clinic.~        3. Blood and urine tests and a physical examination at every treatment visit and a skin~          test at one treatment visit.~        4. Research tests at the end of the 24-week treatment period, including lumbar puncture~          (spinal tap), MRI scan, and apheresis.~        5. After completing treatment, patients have three follow-up clinic visits for blood and~          urine tests, and a skin test at one follow-up visit.~   "
266425|NCT00076830|"~     This study offers evaluation and treatment of patients with a suspected connective tissue~     disorder. The protocol is not designed to test new treatments; rather, patients receive~     standard care. The study is designed to: 1) allow NICHD's staff to learn more about~     connective tissue disorders, 2) train physicians in the evaluation and treatment of these~     disorders; and 3) establish a pool of patients who may be eligible for other NICHD protocols~     for connective tissue disorders. (Participants in this protocol will not be required to join~     another study; the decision will be voluntary.)~      Patients of all ages with a suspected connective tissue disorder and their unaffected family~     members may be eligible for this study.~      Participants undergo diagnostic procedures that may include a medical history, physical~     examination, X-ray studies, eye examinations, and blood drawing, as well as other specialized~     tests, when needed. Additional tests may include:~        -  Blood test for DNA genetic analysis~        -  Skin biopsy: Removal of a small piece of tissue for microscopic examination. The area of~          skin selected for the biopsy is numbed and a small circle of skin, usually from the~          upper arm, is removed with a surgical cookie cutter-like instrument.~        -  Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves~          to show structural and chemical changes in tissues. The patient lies on a table that~          slides into a narrow cylinder containing a magnetic field. Ear plugs are worn to muffle~          loud knocking and thumping sounds that occur with electrical switching of the magnetic~          fields.~        -  Computed tomography (CT) scans: This test allows the doctor to view the organs inside~          the body in small sections. The patient lies in a doughnut-like machine. Scanning can be~          done from different angles, allowing a three dimensional picture of the part of the body~          being studied. It may be done with or without injection of a contrast material.~        -  Referral to appropriate sub-specialists when potential complications are found.~   "
266426|NCT00076726|"~     The purpose of this study is to evaluate the safety and efficacy (effectiveness) of~     Infliximab (Remicade) in patients with Giant Cell Arteritis. Infliximab (Remicade) targets~     specific proteins in the body's immune system to help control the development of inflammation~     to help reduce painful disease.~   "
266427|NCT00076544|"~     The purpose of this open-label study is to give chronic severe pain patients with existing~     intrathecal pump systems access to ziconotide.~   "
266428|NCT00076518|"~     The purpose of this study is to determine the effectiveness of fish oil supplements combined~     with the drug fenofibrate in treating elevated triglyceride levels in people taking anti-HIV~     drugs. The participants in this study will have shown no response to fish oil supplements or~     fenofibrate alone.~   "
266429|NCT00022373|"~     RATIONALE: Iseganan hydrochloride may be effective in preventing or lessening oral mucositis~     in patients who are receiving radiation therapy for head and neck cancer. It is not yet known~     if iseganan hydrochloride is effective in preventing oral mucositis.~      PURPOSE: Randomized phase III trial to determine the effectiveness of iseganan hydrochloride~     in preventing oral mucositis in patients who are receiving radiation therapy for head and~     neck cancer.~   "
266430|NCT00022243|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of T138067 in treating patients who have~     locally advanced or metastatic non-small cell lung cancer that has not responded to previous~     chemotherapy.~   "
266431|NCT00022204|"~     RATIONALE: Vitamin E and pentoxifylline may be effective in decreasing lymphedema in women~     who have received radiation therapy for breast cancer.~      PURPOSE: Randomized phase II trial to determine the effectiveness of combining vitamin E and~     pentoxifylline in treating women who have lymphedema after receiving radiation therapy for~     breast cancer.~   "
266432|NCT00021385|"~     RATIONALE: Squalamine lactate may stop or slow the growth of ovarian cancer by stopping blood~     flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining squalamine lactate with carboplatin may kill~     more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining squalamine lactate and~     carboplatin in treating patients who have recurrent or refractory stage III or stage IV~     ovarian cancer.~   "
266433|NCT00020696|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining tirapazamine with cisplatin~     in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.~   "
266434|NCT00017407|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. ISIS 3521 may help kill more cancer cells by making tumor cells~     more sensitive to chemotherapy. It is not yet known if carboplatin and paclitaxel are more~     effective with or without ISIS 3521.~      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and~     paclitaxel with or without ISIS 3521 in treating patients who have stage IIIB or stage IV~     non-small cell lung cancer.~   "
266435|NCT00014105|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating~     patients who have recurrent glioblastoma multiforme.~   "
266436|NCT00014066|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cnacer cells more sensitive to~     light to kill tumor cells. Brachytherapy uses radiation to damage tumor cells. Photodynamic~     therapy combined with brachytherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy plus brachytherapy~     in treating patients with recurrent lung cancer that is blocking the lung passages.~   "
266437|NCT00010244|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known which regimen of radiation therapy is more effective for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     radiation therapy in treating patients who have localized prostate cancer.~   "
266438|NCT00076752|"~     This study will examine a new approach to treating patients with severe systemic lupus~     erythematosus (SLE) that involves collecting stem cells (cells produced by the bone marrow~     that develop into blood cells) from the patient, completely shutting down the patient's~     immune system, and then giving back the patient's stem cells. SLE is a chronic, inflammatory~     disorder of the immune system that can affect many organs. It is called an autoimmune disease~     because the patient's lymphocytes (white blood cells that normally protect against invading~     organisms), go out of control and attack the body's own tissues.~      Patients between 15 and 40 years of age with severe SLE affecting a major organ that is~     resistant to standard treatment may be eligible for this study. Candidates are screened with~     a medical history and physical examination, blood and urine tests, skin tuberculin test, and~     radiology studies to evaluate the extent of disease. They have endocrinology, nutrition,~     dental, and social work consultations, ultrasound or MUGA (multi-gated acquisition scan) scan~     heart imaging, electrocardiogram and lung function tests, bone marrow biopsy, and lymph node~     aspirate. Depending on which organs are affected, patients may have additional tests, such as~     lumbar puncture (spinal tap), kidney or lung biopsy, MRI (magnetic resonance imaging) of the~     brain and spinal cord, and PET (positron emission tomography) scan. They also complete~     quality of life questionnaires and have disability functional testing and neurocognitive~     (thinking) assessments.~      Participants have a central venous line (plastic tube) inserted into a neck or chest vein for~     administering stem cells and medicines and for drawing blood. They undergo seven apheresis~     procedures during the course of the study to collect stem cells for transplant and for~     research. For apheresis, whole blood is collected through a needle in an arm vein and~     directed to a cell-separating machine where the white cells are extracted and the rest of the~     blood is returned to the patient through the same needle.~      Patients are primed with three medications (methylprednisolone, rituximab, and~     cyclophosphamide) through the central line to help control the disease. In addition, a~     medication called G-CSF (growth colony stimulating factor) is injected under the skin for~     several days to boost production of stem cells. After enough stem cells have been collected~     for transplantation (infusion through the central line), patients are admitted to the~     hospital for an 8-day conditioning regimen followed by transplantation. The conditioning~     treatment consists of rituximab, fludarabine, and cyclophosphamide to eliminate all the white~     blood cells from the blood and bone marrow. The stem cells are then infused and the patient~     is closely monitored by a team of physicians and nurses. When the stem cells have engrafted,~     the bone marrow has recovered, and the patient feels well enough - usually 2 to 3 weeks after~     transplant - the patient is discharged from the hospital. Prednisone tapering begins as soon~     as feasibly possible, but no later then 28 days after transplant.~      Patients return to the National Institutes of Health (NIH) Clinical Center for frequent~     follow-up visits during the first 2 to 3 months following transplant. The time between visits~     is then extended to once every 3 months the first year, then every 6 months the second year,~     and then at least yearly for 5 years after the transplant. These visits include a physical~     examination, blood and urine tests, lumbar puncture (if there is central nervous system~     involvement), other appropriate biopsies and tests as needed to monitor the patient's health,~     short apheresis procedures to collect blood for research purposes, and quality of life~     questionnaires. Some select procedures will be optional. Bone marrow biopsies and lymph node~     aspirates are done at beginning and at 6, 12, and 24 months after transplant. PET scans are~     done at 1, 6, 12, and 24 months.~   "
266439|NCT00076739|"~     This study will use magnetic resonance imaging (MRI) to examine which areas of the brain are~     involved in performing certain cognitive tasks. MRI uses a strong magnetic field and radio~     waves to produce images of body tissues and organs that provide information about structure~     and function of tissues.~      Healthy normal volunteers between 21 and 40 years of age may be eligible for this study.~     Candidates must be native English speakers and must be right-handed. They must have no~     history of nervous system disease or psychiatric disorder. Candidates are screened with~     questionnaires and a neurological examination.~      Participants undergo functional MRI scanning. For this procedure, the subject lies on a~     stretcher that moves into the scanner - a metal cylinder surrounded by a strong magnetic~     field. During the scan, he or she is asked to make various decisions about whether words are~     related or not. Two words are presented visually, separated by a variable time delay. The~     subject reads both words, decides as quickly and accurately as possible whether the two words~     are related or not, and indicates the answer by pressing a button. The test takes about 2~     hours. When it is completed, the subject completes a written questionnaire concerning his or~     her experience in the scanner.~   "
266440|NCT00076713|"~     Antiphospholipid Syndrome (APS) is an autoimmune disorder in which the body recognizes~     certain normal components of blood and/or cell membranes as foreign substances and produces~     antibodies against them. Patients with these antibodies may experience miscarriages and blood~     clotting disorders, including heart attacks and strokes. APS may occur in people with~     systemic lupus erythematosus and other autoimmune diseases, or in otherwise healthy~     individuals.~      The Antiphospholipid Syndrome Collaborative Registry (APSCORE) is a national registry and~     tissue repository for patients with APS. This registry will collect clinical information and~     blood samples from people with APS.~   "
266441|NCT00009997|"~     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy with combination chemotherapy may be an effective~     treatment for locally advanced breast cancer.~      PURPOSE: Phase I trial to study the effectiveness of trastuzumab plus paclitaxel followed by~     surgery and combination chemotherapy in treating women who have locally advanced breast~     cancer.~   "
266442|NCT00009958|"~     Phase I trial to compare the effectiveness of vaccine therapy with or without sargramostim in~     treating patients who have solid tumors. Vaccines may make the body build an immune response~     to kill tumor cells. Combining colony-stimulating factors such as sargramostim with vaccines~     may kill more tumor cells.~   "
266630|NCT00006213|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Phase I trial to study the effectiveness of BMS-214662 in treating patients~     who have acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase~   "
266443|NCT00009906|"~     Randomized phase III trial to compare the effectiveness of two different doses of STI571 in~     treating patients who have metastatic or unresectable gastrointestinal stromal tumor. STI571~     may interfere with the growth of tumor cells and may be an effective treatment for cancer. It~     is not yet known which dose of STI571 is more effective in treating gastrointestinal stromal~     tumors.~   "
266444|NCT00008333|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating~     older patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
266445|NCT00008034|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells and shrink~     tumors so they can be removed during surgery.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery~     in treating women who have locally advanced, inflammatory, or large surgically removable~     breast cancer.~   "
266446|NCT00006460|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperbaric oxygen~     may increase the effectiveness of radiation therapy. Combining hyperbaric oxygen with~     radiation therapy may be an effective treatment for glioblastoma multiforme.~      PURPOSE: Phase I/II trial to study the effectiveness of combining radiation therapy with~     hyperbaric oxygen in treating patients who have newly diagnosed glioblastoma multiforme.~   "
266447|NCT00006454|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if paclitaxel plus carboplatin is more effective with or without topotecan for~     ovarian epithelial cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus~     carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or~     stage IV ovarian epithelial cancer.~   "
266448|NCT00006111|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining surgery with chemotherapy and radiation therapy may be an effective way to treat~     cancer of the urinary tract.~      PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and~     radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of~     the urinary tract .~   "
266449|NCT00076700|"~     This study will determine if the brain regions in blind people that would normally be~     involved in vision are used instead to remember touch. Blind people have an enhanced sense of~     touch compared to sighted people, and they also perform better on tests for certain kinds of~     memory. This study will examine and compare the results of a touch memory test in blind and~     sighted people to determine what brain areas are involved in responding to touch.~      Blind people and sighted volunteers between 18 and 80 years of age who have no psychiatric~     problems or neurological problems (other than blindness) may be eligible for this study.~     Candidates are screened with a medical interview and examination.~      Participants undergo one or both of the following procedures:~      Behavioral experiment~      Sighted participants are blindfolded during this experiment. Subjects sit comfortably in~     front of a table. They are presented with a number of surfaces placed on a table one at a~     time and are given 10 seconds to feel each surface with the index finger on their dominant~     hand. They must concentrate and memorize the surfaces as best they can. After a 15-minute~     break, they are again presented with a series of surfaces and given 10 seconds to feel each~     one. This time, they must say as quickly as possibly whether the surface is one they touched~     previously or is a new surface.~      Functional MRI~      MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues.~     In this study, subjects undergo MRI scanning of the brain while performing the same touch~     test described above. For the MRI, the subject lies on a table that slides into the scanner.~     The MRI machine detects change in the brain regions involved in performing the task.~   "
266450|NCT00006050|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs in different ways may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus~     leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer~     that has spread to the liver.~   "
266451|NCT00005881|"~     RATIONALE: Questionnaires that measure quality of life may improve the ability to plan~     treatment for children with cancer.~      PURPOSE: This randomized clinical trial is studying the quality of life in children treated~     for cancer.~   "
266452|NCT00005792|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus~     peripheral stem cell transplantation in treating patients who have multiple myeloma.~   "
266453|NCT00005064|"~     Phase I trial to study the effectiveness of PS-341 in treating patients who have refractory~     or relapsed acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia in~     blast phase, or myelodysplastic syndrome. PS-341 may stop the growth of cancer cells by~     blocking the enzymes necessary for cancer cell growth~   "
266454|NCT00076648|"~     This study is designed to assess the survival benefit of administering PolyHeme to severely~     injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where~     blood is not available, and continuing throughout a 12-hour postinjury hospital setting.~   "
266455|NCT00076635|"~     Open-label therapy will be administered to up to 220 patients, following completion of either~     InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of~     subcutaneous Interferon gamma-1b. The study duration will be 5 years.~   "
266456|NCT00076674|"~     This study will evaluate the effects of levetiracetam (Keppra (Trademark) on Parkinson's~     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of~     long-term treatment with levodopa. Levetiracetam blocks certain protein receptors on brain~     cells and thus can change the spread of brain signals believed to be affected in patients~     with Parkinson's disease.~      Patients between 30 and 80 years of age with relatively advanced Parkinson's disease and~     dyskinesias due to levodopa therapy may be eligible for this 6-week study.~      Screening and baseline evaluation - Participants are evaluated with a medical history,~     physical examination and neurologic evaluation, blood tests, urinalysis, electrocardiogram~     (EKG), 24-hour holter monitor (heart monitoring), and cardiology consultation. A chest x-ray~     and MRI or CT scan of the brain are done if needed. If possible, patients stop taking all~     antiparkinsonian medications except levodopa (Sinemet) for one month (2 months if taking~     Selegiline) before the study begins and throughout its duration. (If necessary, patients may~     use short-acting agents, such as Mirapex, Requip or Amantadine.)~      Dose-finding phase - Patients are admitted to the NIH Clinical Center for 2 to 3 days for a~     levodopa dose-finding procedure. For this test, patients stop taking Sinemet and instead~     have levodopa infused through a vein. During the infusions, the drug dose is increased slowly~     until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study~     dose is reached. Symptoms are monitored frequently. (Patients who have had dosing infusions~     in the last 3 months do not have to undergo this phase of the study.)~      Active study phase - Patients are randomly assigned to take levetiracetam or placebo (sugar~     pill) twice a day for 6 weeks. At the end of weeks 1, 2 4, and 5, patients come to the~     clinic for blood tests, an EKG, and a review of adverse side effects. At the end of weeks 3~     and 6, patients are hospitalized to study the response to treatment. They again stop taking~     Sinemet and selegiline and their ability to perform motor tasks is evaluated. They are then~     placed on an L-dopa infusion for 10 hours. Placebo may be infused at various times instead of~     L-dopa. Motor symptoms are evaluated several times during the infusion. Blood is drawn once~     during the infusion for research studies.~      Lumbar puncture - Patients undergo a lumbar puncture (spinal tap) at the end of weeks 1 and 4~     to measure certain brain chemicals and drug levels. For this test, a local anesthetic is~     given and a needle is inserted in the space between the vertebrae in the lower back. About 2~     tablespoons of fluid is collected through the needle.~      Magnetic resonance imaging (MRI) - Patients with changing disease activity may undergo MRIs~     at baseline, at the end of week 1 and at the end of the study to show changes in the brain.~     The patient lies in a narrow cylinder (the scanner) that uses radio waves and a magnetic~     field to produce images of the brain, which show structural and chemical changes.~      Follow-up - 2 weeks after the study ends, patients are contacted by phone for a review of~     side effects or they return to the clinic for an evaluation.~   "
266457|NCT00076622|"~     This study will examine therapeutic and adverse effects of continuing versus discontinuing~     antidepressant medication in nursing home residents who have had no more than a single~     episode of depression and who no longer have depressive symptoms.~   "
267378|NCT00011973|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who~     have advanced kidney cancer.~   "
266458|NCT00005022|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus combination~     chemotherapy in treating patients with limited-stage small cell lung cancer.~   "
266459|NCT00004862|"~     Phase I trial to study the effectiveness of augmerosen plus fludarabine and cytarabine in~     treating patients who have refractory or relapsed acute myeloid leukemia or acute~     lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells~     from dividing so they stop growing or die. Gene therapy such as augmerosen may make cancer~     cells more sensitive to chemotherapy drugs. Combining more than one drug with augmerosen may~     kill more cancer cells.~   "
266460|NCT00004239|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of 506U78 in treating patients who have~     hematologic cancer and kidney or liver impairment.~   "
266461|NCT00003888|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug and combining chemotherapy with radiation therapy may kill more~     tumor cells. It is not yet known which regimen of combination chemotherapy is more effective~     for advanced head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of~     combination chemotherapy plus radiation therapy in treating patients who have advanced head~     and neck cancer.~   "
266462|NCT00076609|"~     Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal~     cancers. The advantages of capecitabine are that (1) it is an oral drug; and (2) it is less~     toxic than many other chemotherapeutics. In an off-label hepatocellular carcinoma (HCC)~     clinical study, the response rate with capecitabine was 13%. The botanical drug~     PHY906--currently manufactured pursuant to GMP standards and regulations--has been used in~     China for over 1800 years to treat gastrointestinal-related ailments. Recently, preclinical~     studies demonstrated that PHY906 potentiates the anti-tumor effect of capecitabine. This~     trial will evaluate the safety and efficacy of PHY906 in enhancing the anti-tumor effects of~     capecitabine.~   "
266463|NCT00076557|"~     In this study a modified virus called adeno-associated virus (AAV) will be used to transfer a~     normal gene for human clotting factor IX into patients with severe hemophilia B (AAV human~     Factor IX vector). Gene therapy is a very new medical technique being used in a number of~     clinical studies for diseases such as cancer and cystic fibrosis. At this time, the U.S. Food~     and Drug Administration has approved no gene transfer products for commercial use. To date, 8~     subjects have received AAV vector in the muscle for a hemophilia B trial by intramuscular~     injection, and, to date, 6 subjects have been treated with AAV vector in the current~     hemophilia B liver trial. Eleven cystic fibrosis subjects have received AAV vector into their~     nasal sinuses or lungs to date. In this study, AAV human Factor IX vector will be injected~     into the liver using a catheter inserted into a large blood vessel (called the proper hepatic~     artery or the right hepatic artery).~   "
266464|NCT00076596|"~     This study will examine how the brain controls movements in patients with certain types of~     cerebral palsy. In healthy people, one side of the body usually controls movements on the~     other side of the body. In patients with cerebral palsy, this pattern may be altered, and one~     side of the brain may control movements on the same side of the body. Information obtained~     from this study may lead to improved rehabilitation therapy strategies for patients with~     cerebral palsy.~      Healthy volunteers and patients with cerebral palsy between 6 and 18 years of age may be~     eligible for this study. All candidates will be screened with a medical history, physical~     examination, and psychological testing. In addition, patients with cerebral palsy will have~     hearing and vision tests, a review of their medical records, and a magnetic resonance imaging~     (MRI) scan if one has not been done within the past year. For this test, the patient lies on~     a table that slides into a narrow metal cylinder with a strong magnetic field (the scanner).~     The scanning time usually lasts between 45 and 90 minutes.~      Patients enrolled in the study also will be evaluated by a physiatrist and physical and~     occupational therapists. They will be examined for muscle stiffness and reflexes. Their gait~     and movements (e.g., how they pick up a glass of water) will be evaluated. They will be asked~     about their ability to perform activities around the house and at school and whether a~     wheelchair or walker is needed to get around. Patients may also be asked about how they are~     dealing with their movement problems and how it affects their caregivers.~      All participants will undergo three tests, described below, to evaluate movement control. The~     first two tests use electrodes (small metal discs) taped to the skin over the muscles in both~     hands to measure muscle activity. A small disc placed on the fingers detects and measures the~     hand movements. The third test uses magnetic pulses that stimulate the brain to study how the~     brain controls movements.~        1. Quantitative test of fine motor function: For this test, the subject taps buttons at~          different speeds on a box attached to a computer. The test is similar to playing simple~          computer games.~        2. Long latency reflexes: For this test, the subject's hand is lightly strapped into a~          holder that holds the hand still while a motor moves the index finger with sudden small~          movements. These reflexes may also be tested using a gentle shock to the finger~          delivered through a ring electrode.~        3. Transcranial magnetic stimulation: For this test, the subject sits in a comfortable~          chair. An insulated coil is held on the scalp. A magnetic pulse from the coil stimulates~          the brain. The subject may hear a click and feel a snap or pulling sensation on the~          scalp under the coil. The stimulation may also cause twitching in the muscles of the arm~          or leg. During the stimulation, the subject may be asked to move certain muscles or~          perform other simple actions.~   "
266465|NCT00076583|"~     This study will test a spinal cord reflex called reciprocal inhibition before, during, and~     after learning a motor skill to see if the reflex becomes stronger by learning the movement.~     People learn new motor skills throughout their lives. At first, performing a new skilled~     movement such as riding a bicycle takes effort and is clumsy, but with practice, it becomes~     relatively automatic. The motor cortex (a part of the brain) is very active when a new~     skilled movement is learned, but becomes less active when the movement is over-learned. This~     study will determine whether the spinal cord helps coordinate the pattern of activity between~     groups of muscles once a motor skill is learned.~      Healthy volunteers between 21 and 65 years of age may be eligible for this study. Candidates~     are screened with a medical history and neurological examination.~      Participants are divided into two groups. Group 1 has movement training sessions only and~     Group 2 has both movement training sessions and physiology sessions, as follows:~      Movement training sessions~      For 15 minutes every weekday, participants practice moving their wrist back and forth to make~     a cursor on the computer screen follow a target. Activity of the arm muscles is monitored~     with surface electrodes taped to the skin. The sessions continue until the participant can~     perform the movement well. Group 1 participants return to the clinic a week after the last~     session to perform the movement again to see if their skill level has changed. Each session~     lasts about 20 to 30 minutes.~      Physiology sessions~      In three separate sessions, the reflex for reciprocal inhibition is measured before and at~     several times during the movement task. This is done with nerve conduction studies. A probe~     placed on the skin delivers a low-intensity electrical stimulus. Wires taped to the skin~     record the nerve impulses. To measure reciprocal inhibition, several dozen stimuli are given~     to two nerves in combinations. Each session lasts 2 to 3 hours.~   "
266466|NCT00076570|"~     This study will test the safety and effectiveness of a combination of three drugs followed by~     long-term treatment with just one drug in preventing organ rejection in kidney transplant~     patients. Current anti-rejection medicines are not completely effective in preventing~     rejection. This trial will test how well Thymoglobulin, Tacrolimus, and Sirolimus work~     together post-transplant and if the treatment can be reduced over time to control rejection~     with either Tacrolimus or Sirolimus alone.~      Candidates for kidney transplantation at the National Institutes of Health Clinical Center~     may participate in this 5-year study. Patients will be screened for eligibility with a~     medical history, physical examination, and blood tests.~      Participants will undergo the following tests and procedures:~        -  Central line placement: A large intravenous catheter (plastic tube, or IV line) is~          placed in a vein in the chest or neck under local anesthesia before the transplant~          surgery. The line remains in place for some time during the hospitalization to~          administer Thymoglobulin, antibiotics, and blood, if needed. The line is also used to~          collect blood samples.~        -  Leukapheresis: This procedure for collecting white blood cells is done before the~          transplant. The cells are studied to evaluate the patient's immune system. Whole blood~          is withdrawn through a catheter in an arm vein or through the central line and directed~          into a machine that separates the blood components by spinning. The white cells are~          removed and the red cells and plasma are returned to the body.~        -  Kidney transplant: Patients undergo kidney transplant surgery under general anesthesia.~        -  Immunosuppressive therapy: Patients receive thymoglobulin by vein for 4 days starting 1~          day before the transplant. They also take Tylenol, Benadryl and a steroid~          (methylprednisolone) to help reduce the side effects of the Thymoglobulin. After the~          transplant, patients receive Tacrolimus and Sirolimus by mouth once a day for 6 months~          and then either Tacrolimus or Sirolimus alone indefinitely. In addition, they take~          medicines to help prevent viral and fungal infections for 6 months because the~          immunosuppressive therapy leaves them vulnerable to infection.~        -  Follow-up visits: After hospital discharge, patients return to the Clinical Center twice~          a week for 4 weeks, then every 6 months for 1 year, and then yearly for another 4 years.~          At each visit, the patient's vital signs are checked and blood and urine samples are~          collected. Periodically, patients are also questioned about how they feel and how the~          transplant has affected their quality of life. Kidney biopsies (removal of a small~          amount of kidney tissue through a thin needle) are done when the patient begins~          single-drug immunosuppression (generally 6 months after transplantation) and 1 year~          after that. The biopsied tissue is examined to evaluate how well the kidney is~          responding to the treatment and to determine how to proceed with therapy.~        -  Routine laboratory tests: Routine tests, coordinated by the patient's local physician,~          are done 2 to 3 times a week for the first 2 to 3 months after transplantation, then~          weekly for several more months, and at least monthly for life.~   "
266467|NCT00076531|"~     Phase III trial using an injectable for treatment of prostate cancer.~   "
266468|NCT00076492|"~     The goal of this study is to assess the impact of CoQ10 and GPI 1485 on the progression of~     Parkinson's disease, in order to determine whether it is reasonable to proceed with further~     study of either of these agents.~   "
275378|NCT00000275|"~     The purpose of this study is to evaluate the safety and efficacy of buproprion in treating~     individuals with adult attention-deficit hyperactivity disorder (ADHD) and cocaine~     dependence.~   "
266470|NCT00003852|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral~     stem cell transplantation in treating patients who have germ cell tumors that have not~     responded to previous chemotherapy.~   "
266471|NCT00003683|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in~     treating patients who have metastatic kidney cancer.~   "
266472|NCT00003682|"~     RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing~     so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective~     treatment for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with~     or without doxorubicin in treating patients who have metastatic prostate cancer that has not~     responded to hormone therapy.~   "
266473|NCT00003578|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Bone marrow transplantation may allow doctors to give higher~     doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether high dose~     chemotherapy plus bone marrow transplantation is more effective than high dose chemotherapy~     alone for intermediate- or high-grade non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy~     with or without bone marrow transplantation in treating patients who have intermediate- or~     high-grade non-Hodgkin's lymphoma.~   "
266474|NCT00076505|"~     This study will examine and compare blood samples from healthy volunteers and patients with~     Parkinson's disease to identify abnormalities associated with Parkinson's disease. Disease~     symptoms include slowness of movement, hand or leg shaking, and stiffness. Some patients have~     difficulty with balance. Information from this study may provide information on how~     Parkinson's disease affects the brain and body, and may help lead to a test for earlier~     diagnosis.~      Healthy volunteers and patients with Parkinson's disease who are 18 years of age or older may~     enroll in this study. Participants will undergo the following procedures:~        -  Physical examination, including evaluation of strength, feeling, coordination, and~          balance~        -  Blood drawing: 150 milliliters (about 10 tablespoons) of blood will be drawn~        -  Personal and family medical history~        -  Consent to access medical records for research purposes~      Blood samples will be examined for:~        -  Genetic analysis~        -  Study of specific proteins and lipids~        -  Study of mitochondria (parts of cells that make energy)~   "
266475|NCT00076453|"~     Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This~     study will evaluate the effectiveness of customized shoe inserts in controlling and relieving~     the pain of knee osteoarthritis.~   "
266476|NCT00076440|"~     ALADDIN is a research study to investigate the safety and effectiveness of leuprolide (a~     hormone drug) to improve the cognitive function and slow the progression of Alzheimer's~     disease (AD) in men 65 years and older with mild to moderate Alzheimer's disease who reside~     in the community.~   "
266477|NCT00076401|"~     The purpose of this study is to determine if the drug motexafin gadolinium will be an~     effective treatment for patients who have chronic lymphocytic leukemia (CLL) that has come~     back after treatment or that has stopped responding to treatment.~   "
266478|NCT00076479|"~     This study will examine in healthy individuals and in patients with aphasia (a language~     disturbance that is usually caused by stroke, brain disease, or injury) which parts of the~     brain are involved in naming everyday objects. In most people, language and speech originate~     in the left side of the brain. When this side of the brain is damaged, language function is~     often impaired. Often, however, function partly recovers, possibly because the right half of~     the brain takes over some language functions when the left half is injured.~      Healthy volunteers and patients with aphasia due to stroke may be eligible for this study.~     All candidates must be 18 years of age and older. Patients' aphasia must have occurred as the~     result of a stroke that occurred more than 12 months before entering the study. In addition,~     their stroke must not have affected the brainstem or cerebellum. Candidates will be screened~     with a medical history, brief physical examination, and questionnaire about handedness.~     Participants will undergo the following tests and procedures:~      Session 1: Magnetic resonance scanning (MRI)~      MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to~     obtain images of body organs and tissues, including the brain. The subject lies in a~     cylindrical machine for up to 60 minutes. Loud thumping noises occur when the radiofrequency~     circuits are switched; this noise can be muffled by the use of earplugs.~      Sessions 2 and 3: Picture naming during transcranial magnetic stimulation (TMS)~      For transcranial magnetic stimulation, a wire coil is held on the subject's scalp. A brief~     electrical current is passed through the coil, creating a magnetic pulse that stimulates the~     brain. The subject hears a click and feels a pulling sensation on the skin under the coil.~     There may also be a twitch in the muscles of the arm or leg. During the TMS, subjects are~     asked to name pictures of common everyday objects that appear on a computer screen. They are~     asked to name them as fast and as accurately as possible. Their voice is recorded to~     determine the accuracy of their answers and the time it takes to answer. Subjects may also be~     asked to tense certain muscles slightly or perform other simple actions during the TMS to~     position the coil properly.~   "
266479|NCT00076466|"~     This study will determine: 1) whether learning a task with the dominant hand is accompanied~     by changes in the area of the brain that controls hand movement, and 2) how the brain is able~     to make these changes. Previous studies have shown that practicing a motor task can change~     brain excitability, but it is not known how well brain excitabilities are changed during~     motor learning. This study will measure changes in activity of the part of the brain that~     controls hand movement before, during, and after exercising the hand on a response pad.~      Healthy normal volunteers between 18 and 40 years of age may be eligible for this study.~     Candidates who have not been evaluated at NIH within the past year will be screened with a~     brief interview about their current state of health and clinical and neurological~     examinations. Participants will undergo the following procedures:~      Learning a finger movement/reaction time task~      For this procedure, participants sit in front of a computer monitor with the index, middle,~     ring, and little fingers placed flat on four corresponding buttons of a response pad. They~     are asked to press one of the four buttons as fast as they can in response to an asterisk~     displayed on the monitor. The position of the asterisk indicates which button to push.~     Subjects perform nine sets of 120-button pushes with a 15-minute rest between each set.~     During the rest period, subjects undergo transcranial magnetic stimulation (described below),~     which causes twitches in the hand muscles. The electrical activity corresponding to the~     twitches is recorded by attaching electrodes (small metal disks) to the skin over the hand~     muscles.~      Transcranial magnetic stimulation~      For this test, an insulated wire coil is held over the scalp. A brief electrical current~     passes through the coil, creating a magnetic pulse that electrically stimulates the brain.~     The subject hears a click and may feel a pulling sensation on the scalp under the coil. The~     stimulation may also cause twitching in the muscles of the face, arm, or leg. During the~     stimulation, the subject may be asked to tense certain muscles slightly or perform other~     simple actions.~   "
266480|NCT00076388|"~     The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with~     advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving~     prior treatment with platinum-based chemotherapy.~   "
266481|NCT00076375|"~     Nanocrystalline silver (very small particles of silver) is the active ingredient in Acticoat~     dressings, which have been approved for the treatment of burns and other wounds. Silver has~     been used for decades as an effective antimicrobial agent. In animal studies, nanocrystalline~     silver cream (NPI) has also demonstrated anti-inflammatory activity. Thus, nanocrystalline~     silver cream is being evaluated in the treatment of inflammatory skin conditions such as~     atopic dermatitis (eczema).~      Approximately 180 study subjects with a definitive diagnosis of mild to moderate eczema will~     be enrolled in this study. Subjects will be randomly assigned to treatment with placebo, 0.5%~     NPI or 1% NPI for the 6-week treatment period. Assessments of treatment effect and safety~     will be performed weekly. Upon completion of the study, subjects may be eligible for 12 weeks~     of open-label treatment with 1% NPI.~   "
266482|NCT00076362|"~     This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally~     occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ~     that secretes hormones). The purpose of this trial is to see how an investigational treatment~     controls the hormone insulin by lowering the level of insulin in the body resulting in a~     weight loss in children who are at least 6 years of age but less than 18 years of age. Some~     children in this trial will receive placebo.~      To qualify for this study, you and your child's doctor must feel that your child's weight is~     inadequately controlled within a year from the time of injury to the hypothalamus or tumor of~     the hypothalamus. This study will help to determine if an investigational treatment is of~     benefit in controlling a child's weight.~   "
266483|NCT00003541|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining chemotherapy, radiation therapy, and peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy, radiation~     therapy, and peripheral stem cell transplantation in treating patients who have stage III or~     stage IV mantle cell lymphoma.~   "
266484|NCT00003418|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     exemestane or tamoxifen may fight breast cancer by blocking the uptake of estrogen. It is not~     yet known whether exemestane is more effective than tamoxifen in treating breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of~     tamoxifen in treating postmenopausal women with primary breast cancer who have already~     received 2-3 years of tamoxifen following surgery.~   "
266485|NCT00003364|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug with radiation therapy may kill more tumor cells. The best~     timing for radiation therapy and combination chemotherapy in treating limited stage small~     cell lung cancer is not yet known .~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy given~     at different times along with combination chemotherapy in treating patients with limited~     stage small cell lung cancer.~   "
266486|NCT00003298|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells. E7296 was~     conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in~     patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel~     plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by~     surgery and chemoradiation therapy would be well tolerated and would have a high curative~     resection rate.~   "
266487|NCT00003287|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of combination chemotherapy is more effective in treating patients~     with recurrent or metastatic colorectal cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil,~     leucovorin, and oxaliplatin in different ways in treating patients with recurrent or~     metastatic colorectal cancer.~   "
266488|NCT00076427|"~     This study will collect quantities of white blood cells from patients infected with the~     hepatitis C virus (HCV) for research on the interactions between HCV and the human~     immunodeficiency virus (HIV) in people infected with both of these agents. Several studies~     have shown that infection with HIV adversely affects liver disease due to HCV.~      Patients 18 years of age and older who are infected with both HCV and HIV or with HCV alone~     may be eligible for this study. Candidates must not have liver failure and must not be~     undergoing treatment for HCV at the time of enrollment.~      Participants will undergo leukapheresis to collect white blood cells. This procedure allows~     collection of larger numbers of cells than would be possible with simple blood drawing. For~     the procedure, blood is removed through a needle in the vein of one arm and spun in a machine~     that separates the blood into its components. The white cells are extracted and the rest of~     the blood is re-infused through the same needle or through a needle in the other arm. The~     procedure takes approximately 1-3 hours, depending on the amount of white cells being~     collected. A maximum of three leukapheresis procedures are done. If additional procedures are~     required, the patient will sign a new consent form. Procedures will be limited to no more~     than three times a year, or once every 4 months.~   "
266489|NCT00076414|"~     This study will examine how the anti-HIV protease inhibitor lopinavir/ritonavir (Kaletra®~     (Registered Trademark)) affects the function of the endothelium (lining of the arteries).~     Medications such as protease inhibitors can dramatically change the course of HIV infection~     in many patients; however, among their side effects is development of abnormal lipid levels~     resulting in high cholesterol and insulin resistance. These side effects may damage the~     lining of the arteries that supply blood to the heart, leading to premature coronary artery~     disease. The study will determine whether lopinavir/ritonavir directly affects endothelial~     function and whether it alters cholesterol levels, glucose tolerance, and markers of~     inflammation in people who take the drug for 4 weeks.~      Healthy normal volunteers between 18 and 40 years of age may be eligible for this study.~     Candidates must be HIV-negative and have no history of heart disease, hypertension, or~     diabetes mellitus. They must not have smoked for at least 6 weeks before entering the study.~     Volunteers will be screened with a medical history, physical examination, blood tests~     (including a pregnancy test for women of childbearing potential), and electrocardiogram. In~     addition, candidates will have an oral glucose tolerance test (see description below).~      Participants will undergo the following procedures:~        -  Lopinavir/ritonavir: 4 weeks (3 capsules twice a day) beginning study day 1~        -  Flow-mediated vasodilatation test (study days 0 and 29) - An ultrasound device for~          measuring the size of the brachial artery (artery in the upper arm) is placed just above~          the elbow. The size of the artery is measured before and 5 minutes after blood flow to~          the arm is stopped for 5 minutes, using a blood pressure cuff. The artery is also~          measured before and after taking nitroglycerin, a medicine that dilates blood vessels.~          These measurements tell how well the drug treatment works on the cells lining the~          brachial artery, which is an indicator of coronary artery function. This test takes~          about 1.5 hours.~        -  Forearm blood-flow test (study days 1 and 30): Small tubes are inserted into an artery~          and vein in the forearm at the inside of the elbow. Blood pressure cuffs are placed~          around the upper arm and wrist, and a strain gauge (a rubber band-like device) is placed~          around the forearm. When the blood pressure cuffs are inflated, blood flows into the~          forearm, stretching the strain gauge at a rate proportional to the blood flow. When the~          devices are in place, a salt water solution is injected in the small tube in the artery.~          After 20 minutes, small doses of the following drugs are given through the catheter at~          various intervals: 1) L-NMMA (blocks production of nitric oxide, a substance produced by~          the blood vessels that causes them to dilate); 2) sodium nitroprusside (dilates blood~          vessels, increasing blood flow); 3) acetylcholine (lowers blood pressure); and 4)~          acetylcholine plus L-NMMA. The effect of the different drugs on blood flow in the~          forearm is measured. The study takes about 2 hours to complete.~        -  Blood tests (screening and study days 1,15, 30, and 44)~        -  Electrocardiogram (at screening and on study day 30)~        -  Oral glucose tolerance test (at screening and on study day 30) - A blood sample is~          collected. Then, the subject drinks 300 milliliters of a glucose solution (a liquid that~          contains sugar dissolved in water). Two hours after drinking the solution, blood is~          drawn again to examine how the body responds to the increase blood sugar levels.~   "
266490|NCT00076349|"~     SUMMARY:~      This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1~     followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will~     repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if~     tumor status improves and there are no unacceptable side effects. Patients will be followed~     for up to 2 years or until disease progression.~      RATIONALE:~      Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination~     of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical~     study with Non-Hodgkin's lymphoma patients.~      PURPOSE:~      This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients~     with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.~   "
275379|NCT00000274|"~     The purpose of this study is to evaluate the safety and efficacy of flupenthixol and~     haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.~   "
266491|NCT00076336|"~     This research study was conducted to compare the safety and effectiveness of the~     investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by~     the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The~     results for patients taking LdT will be compared to results for patients taking lamivudine.~   "
266492|NCT00003137|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have advanced cancer of the stomach.~   "
266493|NCT00003007|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give~     higher doses of chemotherapy drugs and kill more tumor cells. Interferon alfa may interfere~     with the growth of cancer cells.~      PURPOSE: Phase II trial to determine the effectiveness of giving interferon alfa after~     chemotherapy and peripheral stem cell transplantation to patients who have stage III or stage~     IV multiple myeloma and who have been treated with high-dose melphalan.~   "
266494|NCT00002840|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an~     effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with~     radiation therapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination~     chemotherapy in patients with resected anaplastic oligodendroglioma.~   "
266495|NCT00002817|"~     RATIONALE: Vaccines may make the body build an immune response to kill melanoma cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     with metastatic melanoma.~   "
266496|NCT00002748|"~     RATIONALE: Inserting the gene for interleukin-2 into a person's neuroblastoma cells may make~     the body build an immune response and kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of using interleukin-2 gene-modified~     neuroblastoma cells in treating children who have refractory or recurrent neuroblastoma.~   "
266497|NCT00076323|"~     This study will evaluate a new and safe testing method for identifying medicines that can~     cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are~     looking for volunteers with G6PD deficiency who would be willing to donate blood samples.~   "
266498|NCT00076310|"~     The goal of this clinical research study is to learn if giving the new drug, Tarceva®~     (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective~     in the treatment of metastatic or recurrent head and neck cancer. The safety of this~     treatment will also be studied.~   "
266499|NCT00076284|"~     This study will determine which of four doses of GW873140 can safely be given to adults to~     lower the amount of virus (HIV-1) in the body. GW873140 is a new type of anti-HIV drug called~     a CCR5 receptor antagonist. CCR5 is a receptor on T cells (a type of white blood cell) where~     HIV-1 enters and then infects the cell. GW873140 is intended to block the CCR5 receptor so~     that HIV-1 cannot enter the cell.~      HIV-1-infected patients 18 years of age and older may be eligible for this study. Candidates~     are screened with a medical history and physical examination, electrocardiogram, and blood~     and urine tests. Some of the blood drawn is used to test the patient's HIV-1 type to see if~     the study drug might lower the amount of HIV-1 in the blood. Women who can become pregnant~     have a pregnancy test.~      Participants are hospitalized for 12 days. They are randomly assigned to take one of the~     following four treatments for 10 days: 1) 200 mg of GW873140 once a day, or placebo (a~     look-alike pill with no active ingredient); 2) 200 mg of GW873140 twice a day, or placebo; 3)~     400 mg of GW873140 once a day, or placebo; or 600 mg of GW873140 twice a day, or placebo.~     Participants record the meals they eat on a diary card. In addition, they undergo the~     following tests and procedures:~      During treatment~        -  Assessment of HIV classification (day 1)~        -  Review of meal diary cards (days 1,2,3,4,5,8, and 10)~        -  Review of any HIV-associated conditions, other medications taken besides the study drug,~          and well-being (days 1,2,3,4,5,8,10, and 11)~        -  Check of vital signs, including blood pressure, pulse, and temperature (days~          1,2,3,4,5,6,7,8,10, and 11)~        -  Weight assessment (days 1 and 10)~        -  Electrocardiogram to measure the electrical activity of the heart (days 1,2,3,8, and 10)~        -  Blood draws for routine laboratory tests, to measure T-cell counts, and to measure HIV~          levels (days 1,2,5,10, and 11)~        -  Urine tests (days 1 and 10)~      Post-treatment~        -  Blood tests to monitor the effect of GW873140 on lowering HIV counts (days 12, 15, 17,~          and 19)~      Follow-up visit (2 weeks after last drug dose--day 24)~        -  Review of medications taken and general well-being~        -  Check of vital signs~        -  Physical examination~        -  Blood and urine tests.~   "
266500|NCT00076271|"~     This study will evaluate and treat children or adults with inherited or developmental eye~     conditions. It will allow specialists in pediatric ophthalmology, genetic ophthalmology, and~     ocular motility at the National Eye Institute (NEI) to learn more about the course of various~     pediatric, genetic, developmental, and eye movement diseases thorough long-term observation~     and treatment. It will also serve as the first step in determining the eligibility of~     patients who may wish to enroll in other NEI clinical research studies or undergo standard~     eye treatments.~      Children with eye conditions, especially inherited or developmental conditions, and adults~     with eye disorders that began in childhood or that likely have a genetic or developmental~     component may be eligible for this study. Participants will undergo some or all of the~     following procedures:~        -  Medical history, including family history.~        -  Physical examination and possibly routine blood tests, x-rays tests, standard eye~          movement recordings, questionnaires, and specialized procedures when needed.~        -  Complete eye examination, including vision test, visual perception, eye pressure (if~          possible), dilation of the pupils to examine the back of the eye (lens, vitreous, and~          retina).~        -  Photographs of the eyes.~        -  Oculography (eye movement recordings) in patients for whom testing will aid in~          diagnosis. This test is done either with goggles placed over the eyes or with a contact~          lens placed on each eye. When the goggles or lenses are in place, the subject looks at a~          series of red targets on a computer screen.~        -  Electroretinography (ERG) in patients with suspected retinal degeneration. This is a~          test of the electrical function of the eyes. Before the test, patients sit in a dark~          room for 30 minutes with their eyes patched. A small electrode (silver disk) is taped to~          their forehead. The eye patches are then removed, the eyes are numbed with drops, and~          contact lenses are placed in the eyes. The contact lenses sense small electrical signals~          generated by the retina when lights flash. During the ERG recording, the patient looks~          inside a large empty bowl. A light flashes, first in the dark and then with a light~          turned on inside the bowl. The test takes 1 hour or less.~      Participants are followed up to 6 times a year for 3 years, depending on the diagnosis and~     treatment.~   "
266501|NCT00076258|"~     This study will assess the effectiveness of an exercise program in improving antidepressant~     medication treatment for individuals with major depressive disorder (MDD).~   "
266502|NCT00076245|"~     This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating~     seasonal affective disorder (SAD), commonly called the winter blues.~   "
266503|NCT00076219|"~     This is a multi-center, prospective, randomized, parallel-group trial of an intensive~     strategy vs conventional strategy of renal replacement therapy for the treatment of acute~     renal failure secondary to acute tubular necrosis in critically ill patients. The primary~     hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10%~     compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to~     45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality,~     1-year all cause mortality, and recovery of renal function by day 28. The study will recruit~     1164 patients over a period of 3 years, 8 months and each patient will be actively followed~     for 60 days.~   "
266504|NCT00076206|"~     The primary objective of this study is to compare the therapeutic response and safety of 3~     oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA)~     who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.~   "
266505|NCT00076232|"~     Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence~     of genital sores is a significant risk factor for becoming infected with HIV. This study will~     test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes~     drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men~     who sleep with men (MSM).~      Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition,~     twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection~     among high risk, HSV-2 seropositive WSM and MSM.~   "
266506|NCT00076154|"~     This study will identify living veterans with amyotrophic lateral sclerosis (ALS) through a~     national registry that is being developed. Diagnosis of ALS will be verified by study~     neurologists via medical record review. Registry participation includes a bi-annual telephone~     interview to collect functional status data.~   "
266507|NCT00076141|"~     The purpose of this study is to gather a mixed racial group of relatively healthy male~     Veterans (for example, White, African-American, and Hispanic), who are at least 50 years of~     age. These men will be followed to see what types of diseases they develop and to determine~     if racial differences in lifestyle, blood test results, or genes are related to the types of~     diseases that are found. Diseases of particular interest are prostate cancer, other cancers,~     cardiovascular disease (for example, heart attacks and stroke), high blood pressure and~     diabetes. The group to be followed will consist of about 16,000 men recruited from about 40~     VA Medical Centers across the country. Each man will be followed for at least five years~     depending on when he enters the study.~   "
266508|NCT00076115|"~     A clinical study to determine the safety and effectiveness of risperidone compared with~     placebo in the treatment of bipolar disorder (manic or mixed type) in children and~     adolescents aged 10 to 17 years.~   "
266509|NCT00076180|"~     This study will examine the use of the humanized Mik-beta-1 (Hu-Mik-beta1) antibody in~     patients with T-cell large granular lymphocytic leukemia (T-LGL). Patients with T-LGL often~     have reduced white blood cells, red blood cells, and platelets, and increased numbers of~     abnormal cells called large granular lymphocytes (LGLs). Patients may have recurrent~     infections, anemia, or abnormal bleeding. Hu-Mik-beta1 attaches to LGL cells and blocks the~     action of growth factors called interleukins that stimulate LGL growth. Blocking these~     interleukins may stop T-LGL leukemia cells from growing. This study will determine the dose~     and frequency of treatment with Hu-Mik-(SqrRoot) 1 that can safely be given to patients to~     coat the surface of their leukemic cells with antibody, determine how long the antibody lasts~     in the blood after injection, and examine the side effects and possible benefits of the drug~     in these patients.~      Patients age 18 or older with T-LGL may be eligible for this study. Candidates will be~     screened with a medical history and physical examination, review of pathology studies, skin~     biopsy, evaluation of rheumatoid arthritis if present, chest x-ray, computerized tomography~     (CT) scans and other imaging studies as needed, bone marrow biopsy, and blood and urine~     tests.~      Participants will receive a single dose of Hu-Mik-beta1 by a 90-minute infusion through a~     vein. Groups of patients will be treated with increasing doses (0.5, 1.0, and 1.5 mg/kg) of~     the antibody. Patients who develop serious drug side effects are taken off the study. The~     treatment requires a 3- to 4-day hospital stay. In addition to Hu-Mik-(SqrRoot) 1 treatment,~     patients will undergo the following tests and procedures:~        -  Collection of blood for 8 days following the dose of Hu-Mik-beta1 to measure blood~          levels of the antibody.~        -  Follow-up visits of 1 to 2 days at 22, 29, and 43 days after the dose of the antibody~          and then every 3 months for a total of 9 months.~        -  Bone marrow aspirate and biopsy if one has not been done within 6 weeks before entering~          the study, and a repeat biopsy if complete remission of T-LGL is achieved after~          completing treatment. For the biopsy, an area of the hip is numbed and a special needle~          is used to draw bone marrow from the hipbone.~        -  Imaging studies, such as chest x-ray and CT scan of the body after completing treatment~          if the screening scans showed abnormalities due to the T-LGL leukemia.~        -  Lymph node biopsy in individuals with enlarged superficial lymph nodes due to T-LGL~          leukemia to see if the treatment is reaching the leukemia in the lymph nodes.~      There may or may not be a direct benefit from participating in this study. However, the~     results may help in the treatment of future patients.~   "
266510|NCT00076089|"~     The purpose of this study is to determine whether roflumilast is effective in the treatment~     of exacerbations in patients with chronic obstructive pulmonary disease (COPD).~   "
266511|NCT00076076|"~     The purpose of this study is to confirm the dose of roflumilast to be used for asthma~     management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on~     pulmonary function and asthma symptoms.~   "
266512|NCT00033735|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether irofulven is effective in treating~     pancreatic cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of irofulven with that of~     fluorouracil in treating patients who have locally advanced or metastatic pancreatic cancer~     that has not responded to previous treatment with gemcitabine.~   "
266513|NCT00027508|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients~     who have malignant mesothelioma that cannot be removed by surgery.~   "
266514|NCT00024401|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who~     have metastatic colorectal cancer.~   "
266515|NCT00002566|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not known whether combining chemotherapy with bone marrow~     transplantation is a more effective treatment for men with germ cell tumors.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with bone marrow transplantation in treating men with relapsed germ cell tumors.~   "
266516|NCT00076102|"~     Background:~      Neurofibromatosis Type 1 (NF1) is an autosomal dominant, progressive genetic disorder~     characterized by diverse clinical manifestations. Patients with NF1 have an increased risk of~     developing tumors of the central and peripheral nervous system including plexiform~     neurofibromas, which are benign nerve sheath tumors that may cause severe morbidity and~     possible mortality. The histopathology of these tumors suggests that events connected with~     formation of fibroblasts might constitute a point of molecular vulnerability. Gene profile~     analysis demonstrates overexpression of fibroblast growth factor, epidermal growth factor,~     and platelet-derived growth factor in plexiform neurofibromas in patients with NF1.~     Pirfenidone is a novel antifibrotic agent that inhibits these and other growth factors.~     Clinical experience in adults has demonstrated that pirfenidone is effective in a variety of~     fibrosing conditions and pirfenidone is presently under study in a phase II trial for adults~     with progressive plexiform neurofibromas. A phase I trial of pirfenidone in children and~     young adults with NF1 and plexiform neurofibromas was completed, and has established the~     phase II dose (the dose resulting in a mean drug exposure [AUC] not more than 1 standard~     deviation below the mean drug exposure [AUC] in adults who received pirfenidone at the dose~     level demonstrating activity in fibrosing conditions). Pirfenidone has been well tolerated.~      Objectives:~      To determine whether pirfenidone increases the time to disease progression based on~     volumetric measurements in children and young adults with NF1 and growing plexiform~     neurofibromas.~      To define the objective response rate to pirfenidone in NF1-related plexiform neurofibromas.~      To describe and define the toxicities of pirfenidone.~      Eligibility:~      Individuals (greater than or equal to 3 years to less than or equal to 21 years of age) with~     a clinical diagnosis of NF1 and inoperable, measurable, and progressive plexiform~     neurofibromas that have the potential to cause substantial morbidity.~      Design:~      The phase II dose will be used in a single stage, single arm phase II trial The natural~     history of the growth of plexiform neurofibromas is unknown. For this reason, time to disease~     progression on the placebo arm of an ongoing National Cancer Institute (NCI) Pediatric~     Oncology Branch (POB) placebo-controlled, double-blind, cross-over phase II trial of the~     farnesyltransferase inhibitor R115777 for children and young adults with NF1 and progressive~     plexiform neurofibromas.~      Funding source - Food and Drug Administration (FDA) Office of Orphan Products Development~     (OOPD)~   "
266517|NCT00076063|"~     This study will test the immune system response to and safety of two HIV vaccines alone and~     in combination: ALVAC-HIV (vCP1452) and LIPO-5. ALVAC-HIV (vCP1452) uses a canarypox virus~     with man-made parts of HIV attached to it. The canarypox virus cannot cause disease in~     people. LIPO-5 is a mixture of five man-made proteins similar to proteins found in HIV.~      These vaccines are not produced from live HIV or from infected cells and do not contain the~     virus. It is not possible to become infected with HIV from these vaccines.~   "
266518|NCT00076050|"~     The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring~     compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women~     who have recently gone through menopause.~      Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally~     occurring spinal bone loss and improve biological and other emotional changes of menopause.~   "
266519|NCT00076037|"~     The effectiveness of a vaccine can be improved by using a prime boost strategy or by using~     an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer)~     followed by the administration of another type vaccine (the booster). An adjuvant is a~     substance that can enhance the immune response when given at the same time as a vaccine.~      This study will evaluate the safety of and immune response to a vaccine designed to be used~     as part of a prime boost strategy. The study will also evaluate the vaccine when given with~     an adjuvant. The vaccine in this study is not produced from live HIV or from infected cells.~     It does not contain HIV, and it cannot cause HIV infection.~   "
266520|NCT00076024|"~     The primary purpose of the study is to determine the time to progression of the combination~     of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not~     received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study~     is to determine the dose of study drug that can be given with docetaxel administered on an~     every 3 week schedule.~   "
266521|NCT00076011|"~     The primary purpose of this protocol is to determine the activity of AG 013736 in patients~     with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.~   "
266522|NCT00075998|"~     -  Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the~          efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by~          subcutaneous (SC) injection, compared with placebo, in patients with IPF~        -  Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in~          North America and Europe~        -  Randomization: 2:1 active-to-placebo ratio~        -  Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for~          patients who meet predefined criteria)~   "
266523|NCT00075985|"~     This is a prospective observational cohort study that is in the process of enrolling and~     following patients on warfarin therapy by utilizing anticoagulation clinics in VA hospitals~     across the US. There are currently 14 sites actively enrolling patients in the study. For~     each octogenarian enrolled a randomly selected patient with atrial fibrillation (AF) younger~     than 80 years of age from the same clinic and receiving warfarin for approximately the same~     duration is enrolled.~   "
266524|NCT00075972|"~     Objectives:~      The long term objectives of this research program are:~        1. To advance the mission of the VHA Boston Healthcare System to deliver comprehensive~          quality healthcare that meets the needs of patients (in this case, who have been~          unresponsive to standard smoking cessation treatment) through research and clinical~          care.~        2. To expand upon our knowledge of the feasibility and effectiveness of commonly-used~          treatments for nicotine dependence.~        3. To further explore variables related to mood and coping that may contribute to or~          prevent successful reduction and cessation of smoking behavior among veterans.~      The short-term objectives of this project are:~        1. To evaluate the feasibility and effectiveness of two adjunctive treatments (a~          mood-focused exposure-based treatment, Mood Tolerance, with Nicotine Replacement Therapy~          [MTNRT] and mood-focused affect-management treatment, Mood Management, with Nicotine~          Replacement Therapy [MMNRT]) aimed at reduction and cessation of smoking behavior among~          veterans who were previously non-responders to smoking cessation treatment in the VA.~        2. To inform equivocal findings in the literature regarding the role of mood as trigger for~          smoking behavior.~        3. To explore selected mood, coping, and individual difference variable that may be~          predictive of successful abstinence from cigarettes among veterans.~   "
266525|NCT00075959|"~     This study will determine if NXY-059 is safe in patients with an acute stroke caused by~     bleeding in the central nervous system. The primary objective was to assess the safety and~     tolerability of NXY-059 compared to placebo.~   "
266526|NCT00075946|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. It is not yet~     known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and~     comparing them to see how well they work in treating patients with low tumor burden indolent~     stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.~   "
266527|NCT00024388|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who~     have locally advanced, metastatic, or unresectable kidney cancer.~   "
266528|NCT00022347|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of TLK286 in treating patients who have~     advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.~   "
266529|NCT00022321|"~     RATIONALE: Monoclonal antibodies such as gemtuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of gemtuzumab in treating~     patients who have myelodysplastic syndrome.~   "
266530|NCT00021333|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may make tumor cells more sensitive to~     radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation~     therapy followed by filgrastim in treating patients who have recurrent head and neck cancer~     or lung cancer.~   "
266531|NCT00021307|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus carboplatin in~     treating patients who have recurrent glioblastoma multiforme.~   "
266532|NCT00075933|"~     ARQ 501, an investigational anticancer drug, is intended to selectively kill cancer cells and~     spare normal cells by restoring and activating cellular checkpoints known to be defective in~     cancer using the Company's unique biology platform, Activated Checkpoint Therapy™ (ACT).~      ARQ 501 has the potential for improved activity and reduced toxicity over other molecular~     approaches and traditional cancer chemotherapy.~   "
266533|NCT00075907|"~     The purpose of this study is to compare the effectiveness of anti-HIV drug regimens with or~     without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if~     monitoring drug levels and adjusting the dose as necessary improves the effectiveness of~     these regimens.~   "
266534|NCT00075894|"~     RATIONALE: Drugs used in chemotherapy, such as alanosine, use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of alanosine in~     treating patients with high-grade progressive or recurrent malignant gliomas.~   "
266535|NCT00075881|"~     This phase II trial studies how well bortezomib works in treating patients with newly~     diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth.~   "
266536|NCT00075868|"~     RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who~     are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether~     octreotide is effective in treating diarrhea.~      PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing~     diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.~   "
266537|NCT00075855|"~     RATIONALE: The hormone testosterone may improve the libido (sex drive) in women. It is not~     yet known whether testosterone is effective in improving libido in female cancer survivors.~      PURPOSE: This randomized phase III trial is studying how well low-dose testosterone works to~     improve libido in postmenopausal cancer survivors.~   "
266538|NCT00075842|"~     RATIONALE: The herb Valeriana officinalis (valerian) may promote sleep. It is not yet known~     whether valerian is effective in improving sleep in patients who are receiving adjuvant~     therapy for cancer.~      PURPOSE: This randomized phase III trial is studying how well valerian improves the quality~     of sleep in patients who are receiving adjuvant therapy (radiation therapy, chemotherapy, or~     hormone therapy) for cancer.~   "
266539|NCT00075829|"~     The study is designed as a Phase III, multi-center trial of tandem autologous transplants~     versus the strategy of autologous followed by Human Leukocyte Antigen (HLA)-matched sibling~     non-myeloablative allogeneic transplant. Study subjects will be biologically assigned to the~     appropriate arm depending on the availability of an HLA-matched sibling. There is a nested~     randomized phase III trial of observation versus maintenance therapy following the second~     autologous transplant for patients on the tandem autologous transplant arm.~   "
266540|NCT00075816|"~     The study is designed as a Phase III, randomized, open label, multicenter, prospective,~     comparative trial of granulocyte colony stimulating factor (G-CSF)-mobilized peripheral blood~     stem cells (PBSC) versus marrow from unrelated donors for transplantation in patients with~     hematologic malignancies. Recipients will be stratified by transplant center and disease risk~     and will be randomized to either the PBSC or marrow arm in a 1:1 ratio.~   "
266541|NCT00075803|"~     The study is designed as a Phase III, randomized, double-blind, multicenter, prospective,~     comparative study of fluconazole versus voriconazole for the prevention of fungal infections~     in allogeneic transplant recipients. Recipients will be stratified by center and donor type~     (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm~     in a 1:1 ratio.~   "
266542|NCT00075777|"~     RATIONALE: Valproic acid may help stop the growth of Kaposi's sarcoma cells by blocking the~     enzymes necessary for tumor cell growth.~      PURPOSE: This clinical trial is studying valproic acid in treating patients with HIV-related~     Kaposi's sarcoma.~   "
266543|NCT00075764|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of~     estrogen. It is not yet known whether anastrozole is more effective with or without~     fulvestrant in treating breast cancer.~      PURPOSE: This randomized phase III trial is studying giving anastrozole together with~     fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in~     treating postmenopausal women with metastatic breast cancer.~   "
266544|NCT00075751|"~     Phase II trial to study the effectiveness of combining bortezomib with gemcitabine and~     carboplatin in treating patients who have advanced or recurrent non-small cell lung cancer~     that has not been previously treated with chemotherapy. Drugs used in chemotherapy, such as~     gemcitabine and carboplatin, work in different ways to stop tumor cells from dividing so they~     stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes~     necessary for their growth. Bortezomib may also help gemcitabine and carboplatin kill more~     tumor cells by making the cells more sensitive to the drugs~   "
266545|NCT00075738|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and~     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Giving more than one chemotherapy drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy as~     first-line therapy works in treating patients with metastatic esophageal cancer.~   "
266546|NCT00075725|"~     RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and~     leucovorin calcium (LCV), work in different ways to stop cancer cells from dividing so they~     stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet~     known which combination chemotherapy regimen is more effective in treating acute~     lymphoblastic leukemia.~      PURPOSE: This randomized phase III trial is studying dexamethasone to see how well it works~     compared to prednisone during induction therapy. This trial is also studying methotrexate and~     leucovorin calcium to see how well they work compared to methotrexate alone during~     maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia.~   "
266547|NCT00075712|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink~     the tumor so that it can be removed; giving chemotherapy after surgery may kill any remaining~     tumor cells. It is not yet known whether giving chemotherapy before and after surgery is more~     effective than giving chemotherapy after surgery in treating ovarian epithelial, fallopian~     tube, or primary peritoneal cavity cancer.~      PURPOSE: This randomized phase II/III trial is studying how well giving chemotherapy before~     and after surgery works and compares it to giving chemotherapy after surgery alone in~     treating patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or~     primary peritoneal cavity cancer.~   "
266548|NCT00075699|"~     RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and~     general discomfort in patients with malignant pleural mesothelioma. It is not yet known if~     active symptom control is more effective with or without chemotherapy.~      PURPOSE: This randomized phase III trial is studying active symptom control and chemotherapy~     to see how well they work compared to active symptom control alone in treating patients with~     malignant pleural mesothelioma.~   "
266549|NCT00075686|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as~     cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to~     them without harming normal cells. It is not yet known whether gemcitabine is more effective~     with or without cetuximab in treating pancreatic cancer.~      PURPOSE: This randomized phase III trial is studying giving gemcitabine together with~     cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy~     in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the~     pancreas.~   "
266550|NCT00075920|"~     This study will examine heart function using two imaging techniques - echocardiography~     (ultrasound) and magnetic resonance imaging (MRI) - to evaluate newly developed software for~     echocardiograph machines. MRI and ultrasound both provide images of the heart structure and~     function. MRI uses a magnetic field and radio waves to obtain the pictures, while~     echocardiography uses sound waves.~      Patients with any form of heart disease and healthy volunteers 21 years of age and older may~     be eligible for this study. Candidates must be and able to undergo magnetic resonance imaging~     and must not have an irregular heart rhythm, heart valve disease, a pacemaker, defibrillator~     implant, insulin pump, or other metallic implant.~      Participants will have two ultrasound examinations and two magnetic resonance imaging~     examinations, as described below. All the tests will be completed within 24 to 48 hours.~      Echocardiography :~      For this test, a small probe is passed over the chest. Sound waves emitted from the probe~     bounce off the heart and are beamed back into the echo machine where they are recorded. The~     sonographer does a baseline test, which is evaluated by the physician. Then, after a 10- to~     20-minute break, portions of the test are repeated. The entire exam takes about 2 hours.~      Magnetic Resonance Imaging:~      For MRI, the subject lies on a table that slides into a long doughnut-shaped scanner. A small~     tube is placed in a vein in the hand or arm to give fluids and to infuse gadolinium, a~     contrast material that brightens the images. Heart rate and blood pressure are monitored~     during the study, which takes about 3 hours.~   "
266551|NCT00075673|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Combining vinorelbine with~     celecoxib may kill more tumor cells.~      PURPOSE: Phase I trial to determine the effectiveness of combining vinorelbine with celecoxib~     in treating women who have relapsed or metastatic breast cancer.~   "
266552|NCT00075660|"~     RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have~     locally recurrent or metastatic renal cell (kidney) carcinoma (cancer).~   "
266553|NCT00075647|"~     Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from~     dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works~     in treating patients with locally advanced or metastatic pancreatic cancer~   "
266554|NCT00075634|"~     This phase I trial is studying the side effects and best dose of decitabine when given~     together with doxorubicin and cyclophosphamide in treating children with relapsed or~     refractory solid tumors or neuroblastoma. Drugs used in chemotherapy, such as decitabine,~     doxorubicin, and cyclophosphamide, work in different ways to stop tumor cells from dividing~     so they stop growing or die. Combining more than one drug may kill more tumor cells.~   "
266555|NCT00075621|"~     RATIONALE: Autologous stem cell transplantation may be effective treatment for primary~     systemic (AL) amyloidosis.~      PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell~     transplantation works in treating patients with primary systemic (AL) amyloidosis.~   "
266556|NCT00075608|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma~     cells, either by killing the cells or by stopping them from dividing. Having a stem cell~     transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses~     of chemotherapy to be given so that more plasma cells are killed. By reducing the number of~     plasma cells, the disease may progress more slowly.~      PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in~     treating patients with persistent or recurrent primary systemic (AL) amyloidosis.~   "
266557|NCT00075595|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use~     different ways to stop tumor cells from dividing so they stop growing or die. Giving more~     than one chemotherapy drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving fluorouracil together with~     leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic~     unresectable colorectal cancer.~   "
266558|NCT00075582|"~     This phase III trial is studying how well combination chemotherapy and radiation therapy work~     in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in~     chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways~     to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may~     kill more tumor cells. It is not yet known which treatment regimen is more effective in~     treating low-risk rhabdomyosarcoma.~   "
266559|NCT00075569|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer or to treat early cancer. SGN-00101 may be effective in preventing the~     development of cervical cancer in patients who have cervical intraepithelial neoplasia.~      PURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing~     cervical cancer in patients with grade III cervical intraepithelial neoplasia.~   "
266560|NCT00075556|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining radiation therapy with chemotherapy before surgery may~     shrink the tumor so that it can be removed.~      PURPOSE: This phase II trial is studying how well neoadjuvant radiation therapy and~     capecitabine work in treating patients who are undergoing surgery for stage III or stage IV~     colorectal adenocarcinoma.~   "
266561|NCT00075543|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug~     may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and~     oxaliplatin and to see how well they work in treating patients with stage III or stage IV~     ovarian epithelial cancer.~   "
266562|NCT00075517|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways~     to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel~     works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.~   "
266563|NCT00075504|"~     This phase II trial is studying how well giving 3-AP together with gemcitabine works in~     treating patients with unresectable or metastatic bile duct or gallbladder cancer. Drugs used~     in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells~     from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells~     by making them more sensitive to the drug.~   "
266564|NCT00075491|"~     This randomized phase II trial is studying how well neoadjuvant and adjuvant fenretinide~     works compared to adjuvant fenretinide alone in treating patients who are undergoing surgical~     resection for recurrent glioblastoma multiforme. Chemotherapy drugs, such as fenretinide,~     work in different ways to stop tumor cells from dividing so they stop growing or die. Giving~     chemotherapy before surgery may shrink the tumor so that it can be removed. Giving~     chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether~     neoadjuvant and adjuvant fenretinide is more effective than adjuvant fenretinide alone~   "
266565|NCT00075478|"~     This randomized phase III trial is studying total-body irradiation (TBI) and fludarabine~     phosphate to see how it works compared with TBI alone followed by donor stem cell transplant~     in treating patients with hematologic cancer. Giving low doses of chemotherapy, such as~     fludarabine phosphate, and radiation therapy before a donor stem cell transplant helps stop~     the growth of cancer cells. It also stops the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune system cells and~     help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from~     happening. It is not yet known whether TBI followed by donor stem cell transplant is more~     effective with or without fludarabine phosphate in treating hematologic cancer.~   "
266566|NCT00075465|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin~     as first-line therapy works in treating patients with locally advanced or metastatic~     adenocarcinoma (cancer) of the stomach.~   "
266567|NCT00075452|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. It is not yet known~     whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic~     adenocarcinoma.~      PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how~     well they work compared to gemcitabine alone in treating patients with locally advanced or~     metastatic unresectable pancreatic adenocarcinoma.~   "
266568|NCT00075439|"~     This phase II trial is studying how well gefitinib works in treating patients with~     progressive metastatic neuroendocrine tumors. Gefitinib may stop the growth of tumor cells by~     blocking the enzymes necessary for their growth.~   "
266569|NCT00075426|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients~     with locally advanced or metastatic non-small cell lung cancer.~   "
266570|NCT00075413|"~     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating women~     with locally advanced or metastatic breast cancer.~   "
266571|NCT00075400|"~     This phase II clinical trial studies the side effects and how well imatinib mesylate works in~     treating patients with uterine cancer that has failed to respond to initial chemotherapy or~     has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
266572|NCT00075387|"~     This randomized phase II trial studies how well giving combination chemotherapy with or~     without sodium thiosulfate works in preventing low platelet count while treating patients~     with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin,~     cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving~     chemotherapy. It is not yet known whether combination chemotherapy is more effective with or~     without sodium thiosulfate in preventing low platelet count during treatment for brain~     tumors.~   "
275414|NCT00000237|"~     The purpose of this study is to examine the long-term efficacy of alternate-day dosing~     schedules in promoting treatment compliance in the absence of confounding behavioral~     contingencies.~   "
266573|NCT00075374|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor~     cells from dividing so they stop growing or die. It is not yet known which docetaxel regimen~     is more effective for non-small cell lung cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel~     in treating patients who have not previously received chemotherapy for unresectable stage~     IIIB or stage IV non-small cell lung cancer.~   "
266574|NCT00075348|"~     RATIONALE: The identification of gene mutations in individuals who have or are at risk for~     von Hippel-Lindau syndrome may allow doctors to better determine the genetic processes~     involved in the development of cancer.~      PURPOSE: This genetic study is finding gene mutations in participants with von Hippel-Lindau~     syndrome or who are at risk for developing von Hippel-Lindau syndrome.~   "
266575|NCT00075335|"~     Peripheral blood progenitor cells (PBPC) have become the preferred source of hematopoetic~     stem cells for allogeneic transplantation because of technical ease of collection and shorter~     time required for engraftment. Traditionally, granulocyte-colony stimulating factor (G-CSF)~     has been used to procure the peripheral blood stem cell graft. Although regimens using G-CSF~     usually succeed in collecting adequate numbers of PBPC from healthy donors, 5%-10% will~     mobilize stem cells poorly and may require multiple large volume apheresis or bone marrow~     harvesting. Although G-CSF is generally well tolerated in healthy donors, it may be~     associated with bone pain, headache, myalgia and rarely life threatening side effects like~     stroke, myocardial infarction and splenic rupture.~      AMD3100, is a bicyclam compound that inhibits the binding of stromal cell derived factor-1~     (SDF-1) to its cognate receptor CXC- chemokine receptor 4 (CXCR4). CXCR4 is present on~     cluster of differentiation 34 (CD34)+ hematopoetic progenitor cells and its interaction with~     stromal cell derived factor 1 (SDF-1) plays a pivotal role in the homing of CD34+ cells in~     the bone marrow. Inhibition of the CXCR4-SDF1 axis by AMD3100 releases CD34+ cells into the~     circulation, which can then be collected easily by apheresis.~      Recently, a published report demonstrated that large numbers of CD34+ cells were rapidly~     mobilized in healthy volunteers following a single subcutaneous injection of AMD3100.~     Remarkably, the number of CD34+ cells collected by apheresis following a single injection of~     AMD3100 was comparable to the number of CD34+ cells collected from historical controls~     receiving 5 days of G-CSF prior to stem cell mobilization.~      In this study we will collect PBPCs following a single subcutaneous injection of AMD3100 from~     healthy donors who have previously had PBPC collected using standard G-CSF mobilization. The~     AMD3100 mobilized cells, G-CSF mobilized cells, and circulating cells prior to both AMD3100~     and G-CSF mobilization will be analyzed in terms of cellular content and function of~     lymphocytes, natural killer (NK) cells, and antigen presenting cells. AMD3100 mobilized PBPC~     will be collected for the purpose of research studies and will not be used for therapeutic~     purposes.~   "
266576|NCT00075296|"~     This study will examine how the brains of depressed people function during learning and~     respond to feedback. Participants perform a probabilistic reversal learning task to~     determine whether depressed people perform worse on a task than non-depressed people when~     they sometimes receive misleading negative feedback.~      Right-handed healthy volunteers, people with major depression who are currently depressed or~     have previously been depressed and people with bipolar depression between 18 and 50 years of~     age may be eligible for this study. Candidates are screened with a medical and psychiatric~     history, physical examination, electrocardiogram, blood and urine tests. They are also~     interviewed to evaluate mood, sleep, energy, work and school performance, and social~     relationships, and asked to answer questions to investigate whether any history of paranoia,~     panic attacks, obsession, compulsions, suicidal thoughts, eating disturbances, and alcohol or~     drug abuse is present. They complete rating scales for depression, anxiety, and negative~     thinking; history of alcohol and tobacco use; physical movement; socioeconomic status;~     overall level of functioning; and depression type. Finally, they undergo a battery of~     neuropsychological tests to assess general intelligence, handedness, and specific cognitive~     abilities, including memory and concentration.~      Participants perform the probabilistic reversal learning task either in a testing room seated~     in front of a computer or lying down while undergoing functional magnetic resonance imaging~     (FMRI). FMRI is a diagnostic test that uses a strong magnet and radio waves to obtain~     pictures of brain structure and function. For the scan, the subject lies on a narrow bed with~     a plastic-encased metal coil close to the head. The bed slides into the scanner - a small~     tunnel about 6 feet long. All subjects, whether in the testing room or in the MRI scanner,~     undergo the learning task as follows:~      Two patterns are presented on a computer screen. One pattern is designated correct and the~     other incorrect. Subjects are asked to choose the correct pattern on each try and are~     provided feedback as to whether the response was right or wrong. Sometimes the rule changes,~     and the pattern that was correct is now wrong, and vice versa, so that the new correct~     pattern must be chosen. In addition, misleading feedback is sometimes given intentionally,~     indicating the subject chose the wrong pattern when in fact the response was correct.~     Subjects should change their response only when they are sure that the rule has changed, and~     not because they were incorrectly told that they were wrong. For patients undergoing MRI,~     blood flow in the different areas of the brain is measured during the test.~      After the test, outside the scanner, participants undergo additional tests of attention,~     memory, and concentration like those that were administered during the screening procedures.~   "
266577|NCT00075283|"~     The overall goal of this study is to determine whether robotic-assisted gait training is~     better than standard physical therapy treatments for improving walking ability in hemiparetic~     stroke patients.~   "
266578|NCT00075270|"~     The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine~     kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in~     first line advanced or metastatic breast cancer.~   "
266579|NCT00075257|"~     Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment~     in reducing the relapse rate of depressive symptoms in subjects with major depressive~     disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between~     DVS-233 SR and placebo treatment groups by using survival analysis.~      Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the~     clinical global evaluation, functionality, general well-being, pain, and absence of symptoms~     (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] < 7).~   "
266580|NCT00075231|"~     The purpose of this study is to determine whether a simplified lopinavir-ritonavir based~     therapy will continue to keep the viral load to very low levels after initial treatment with~     a combination of Kaletra® (lopinavir/ritonavir) plus Combivir® (lamivudine/zidovudine).~   "
266581|NCT00075218|"~     A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal~     stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to~     imatinib treatment.~   "
266582|NCT00075153|"~     The purpose of this study is to characterize the quality of life (QOL) and longitudinal~     patterns of change in QOL outcomes in children and youth with HIV infection; to identify~     demographic, social, disease status, treatment, and health care utilization factors that~     predict longitudinal changes in outcomes; to develop a conceptual model that characterizes~     the effects of specific factors that predict longitudinal changes in QOL; and to characterize~     the influence of HIV symptoms on QOL outcomes in the domains of health perceptions, physical,~     psychological, and social role functioning.~   "
266583|NCT00020787|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy and~     chemotherapy in treating patients who have metastatic or locally recurrent stomach cancer or~     esophageal cancer.~   "
266663|NCT00074542|"~     The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission~     in subjects with Crohn's Disease who are responding to steroid induction therapy.~      Patient safety and quality of life will also be monitored throughout the study.~   "
266584|NCT00017576|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Calcitriol may help carboplatin kill more cancer cells by making~     tumor cells more sensitive to the drug.~      PURPOSE: Phase II trial to study the effectiveness of carboplatin plus calcitriol in treating~     patients who have prostate cancer that has not responded to hormone therapy.~   "
266585|NCT00017537|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have metastatic or recurrent cancer.~   "
266586|NCT00017433|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have relapsed or refractory stage II or stage III multiple myeloma.~   "
266587|NCT00075244|"~     The main goal of this study is to assess the pharmacodynamic effects of different or more~     frequent doses of Replagal compared to the standard dosing regimen. Replagal is a genetically~     engineered form of alpha-Galactosidase A, an enzyme that normally breaks down a fatty~     substance called globotriaosylceramide (Gb(3)). In patients with Fabry disease, GB(3) does~     not function properly and therefore builds up causing problems with the kidneys, heart,~     nerves, and blood vessels.~      Male patients 18 years of age or older with Fabry disease who are not on dialysis and have~     not received a kidney transplant may be eligible for this study.~      Participants are randomly assigned to receive one of the following five regimens of Replagal~     infusions, given through a vein over 20 to 80 minutes:~      0.1 mg/kg body weight every week~      0.2 mg/kg body weight every week~      0.2 mg/kg body weight every other week~      0.4 mg/kg body weight every week~      0.4 mg/kg body wieght every other week~      In the US, the infusions are given at the NIH Clinical Center. Vital signs are measured~     before, immediately after, and 1 hour after each infusion.~      Baseline evaluations are done on an inpatient or outpatient basis. Baseline tests include a~     check of vital signs (temperature, respiratory rate, pulse rate, and blood pressure);~     physical examination; laboratory tests; and review of treatment side effects. Evaluations are~     also done at every infusion visit, and 1 week and 1 month after the last infusion.~      Safety evaluations are done periodically and include vital sign measurements, physical~     examination, blood and urine tests, review of drug side effects, electrocardiogram (ECG),~     Holder monitor (2 hour ECG), and QSART (NIH only). The QSART (quantitative sudomotor axon~     reflex test) measures the amount of sweat in a particular area of skin, mostly the forearm.~     For this test, a cup partly filled with a liquid is strapped on the arm. A weak electric~     current is turned on, stimulating the sweat glands, and the amount of sweat produced is~     measured. There is a tingling sensation when the current is turned on.~      Patients who complete the study will be offered the opportunity of receiving Replagal for 6~     months in an extension study.~   "
266588|NCT00075192|"~     This is a multi-center, open label, randomized study. Patients will be randomized to one of~     the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 +~     neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization,~     patients will receive study treatment for three cycles (one cycle is defined as 28 days).~     After completion of three cycles, patients will undergo a prostatectomy and pathology~     assessments will be completed at a central laboratory, the Armed Forces Institute of~     Pathology (AFIP) in Washington, DC.~   "
266589|NCT00017082|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who~     have recurrent metastatic colorectal cancer.~   "
266590|NCT00016237|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.~     Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing~     substances to them without harming normal cells. Interleukin-2 combined with a monoclonal~     antibody may be an effective treatment for kidney, bladder, or lung cancer.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 combined with a monoclonal~     antibody in treating patients who have kidney, bladder, or lung cancer that has not responded~     to previous treatment.~   "
266591|NCT00016198|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and~     leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic~     colorectal cancer.~   "
266592|NCT00014404|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. The use of celecoxib may be an effective way to prevent the further~     development of precancerous lesions in the mouth.~      PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of~     celecoxib in treating patients who have precancerous lesions in the mouth.~   "
266593|NCT00014287|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving the drugs in different ways may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of gemcitabine given directly into the~     bladder in treating patients who have recurrent or refractory bladder cancer.~   "
266594|NCT00075205|"~     This study will examine whether Rimonabant, a drug that blocks cannabinoid-1 (CB1) receptors~     in the brain, affects alcohol consumption. Substances called endocannabinoids, which have~     many of the same effects of marijuana, bind to CB1 receptors. Animal studies show that when~     CB1 receptors are blocked, the animals consume less alcohol.~      Healthy normal volunteers between 21 and 40 years of age who consume between 20 and 40~     alcoholic drinks per week, drink at least 4 days a week, and are not seeking treatment for~     alcoholism may be eligible for this study. Candidates are screened with a medical history,~     including questions about alcohol and drug use, physical examination, blood and urine tests,~     breath alcohol test, and electrocardiogram.~      Participants are asked about their mental health history and use of alcohol, cigarettes and~     illicit drugs, and fill out questionnaires evaluating their emotional state and personality.~     Then, they begin a baseline evaluation in which they call a number at the NIH Clinical Center~     for 21 days to report how much alcohol they drank that day. One week after starting the~     baseline evaluation, they are randomly assigned to take either Rimonabant or placebo (a pill~     with no active ingredient) for 2 weeks. Before starting the drug, they have a urine drug~     screen and measurement of blood alcohol level. After 1 week on the test medication, they~     return to the Clinical Center to monitor drug or placebo side effects, if any, and to have a~     blood alcohol level test, urine drug screen, and blood tests for routine blood chemistries.~     After 2 weeks on the test medication, they come to the Clinical Center at noon for an alcohol~     self-administration test. Before the test, they are given a breath alcohol test and a urine~     drug test. The results of both tests must be negative to continue in the study.~      The alcohol self-administration test is videotaped. A heparin lock is placed in a vein in the~     participant's arm. This small needle remains in the arm for the duration of the study to~     avoid multiple needle sticks for blood draws. Blood is drawn periodically during the test to~     determine routine laboratory values, cotinine level (assessment of smoking status), the~     amount of Rimonabant or placebo in the body, and levels of various hormones. Thirty minutes~     before the test begins and every 30 minutes during the test, participants complete~     questionnaires and rating scales regarding their mood and desire to drink. Five minutes~     before the test be...~   "
266631|NCT00006104|"~     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating~     women who have recurrent or metastatic breast cancer.~   "
266595|NCT00075179|"~     The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is~     effective in lowering the pressure in your lungs.~      The primary objective of this study is to establish that Nesiritide (Natrecor) is effective~     in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean~     pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in~     pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of~     toxicity, and surgeon's willingness to proceed with operation.~   "
266596|NCT00075166|"~     This study will compare the effectiveness of craniotomy to that of stereotactic surgery (SRS)~     for the treatment of metastatic brain tumors - tumors that first develop elsewhere in the~     body and then travel to the brain. Craniotomy is surgical removal of the tumors through an~     operation. SRS consists of highly focused radiation doses to the tumors. Neither treatment is~     experimental and both have shown benefits to patients with metastatic brain tumors. This~     study will determine whether one treatment is superior to the other in prolonging patient~     survival.~      Patients 21 years of age and older with one to three metastatic brain tumors may be eligible~     for this study. Participants will have a medical history and physical examination, blood and~     urine tests, an electrocardiogram, and chest x-ray. They will then be randomly assigned to~     undergo either surgery or SRS. Before either procedure, patients will have a magnetic~     resonance imaging (MRI) scan. MRI uses a strong magnetic field and radio waves to obtain~     images of the brain. Patients scheduled for SRS will have a computed tomography (CT) scan in~     addition to the MRI. CT uses X-rays to obtain images of the brain. During the CT, a contrast~     agent is injected through an IV tube placed in a vein to enhance the CT images. For both the~     MRI and CT tests, the patient lies on a table that slides into a cylindrical scanner. The MRI~     usually lasts between 45 and 90 minutes, while the CT scan lasts for about 30 to 60 minutes.~      Patients scheduled for surgery will have general anesthesia or local anesthesia with~     sedation. They will be in intensive care after the surgery until their condition is stable.~     Before being discharged home, they will have another MRI scan. The surgical sutures or~     staples will be removed 7 to 10 days after surgery.~      Patients scheduled for SRS will have their scalp numbed with medicine and their head will be~     placed in a head frame. A CT scan will be done on the morning of the procedure to plan the~     treatment. Around noon, the treatment, which consists of brief exposures to radiation, will~     be administered with the patient positioned comfortably on a treatment couch. The treatment~     will be completed in 1 to 2 hours, after which the head frame will be removed. After a brief~     period of observation, the patient will be discharged home.~      Patients will return to NIH for follow-up visits within 4 weeks after surgery or SRS and then~     every 3 months after that for a medical history, physical examination, and MRI scan, and to~     complete a quality of life questionnaire.~   "
266597|NCT00075140|"~     The purpose of this study is to identify health management concerns and needs of family~     members of asymptomatic and symptomatic persons with mutation in the gene for Huntington~     Disease (HD).~   "
266598|NCT00075114|"~     The purpose of this study is to determine the capacity of self-efficacy to predict~     maintaining a behavior change at four years post urinary control intervention.~   "
266599|NCT00075101|"~     The purpose of this study is to determine the relationship between dexamethosone (steroid)~     and children's sleep and fatigue.~   "
266600|NCT00075088|"~     The purpose of this study is to see whether individuals who access the 911 emergency~     medical system with a heart attack or severe chest pain will receive more timely hospital~     treatment and better outcomes if hospital clinicians are provided with earlier and more~     complete electrocardiography (ECG) information.~   "
266601|NCT00075075|"~     This small, preliminary study will examine whether multiple infusions of infliximab~     (Remicade® (Registered Trademark)) can control inflammation in patients with active~     scleritis. The sclera is the tough white outer coat enclosing the eyeball. Infliximab is a~     combination of part human and part mouse proteins that block a natural body protein called~     tumor necrosis factor (TNF). TNF appears to be involved in scleritis, and stopping its action~     may help reduce the inflammation in the disease. The drug has been approved by the Food and~     Drug Administration for treating Crohn's disease and rheumatoid arthritis.~      Patients 18 years of age or older with active non-infectious scleritis may be eligible for~     this study. Participants will undergo the following tests and procedures:~        -  Medical history and physical examination.~        -  Eye examination, including a vision test and examination of the retina (back part of the~          eye) and of the sclera and its blood vessels.~        -  Questionnaire about vision and daily activities.~        -  Tuberculin skin test.~        -  Pregnancy test: Women who can have children are tested for pregnancy at study weeks 0,~          14, 30, 38, and 46.~        -  Infliximab treatment: Infliximab is infused over a 2-hour period through a needle in a~          vein, usually in the arm. The patient's vital signs are checked before the patient~          begins each infusion starts and again before leaving the clinic. After the first two~          infusions, if the disease remains quiet, other scleritis medications will be attempted~          to be reduced to half the original dose over 8 to 12 weeks and possibly to nothing if~          the patient continues to do well. Patients receive a maximum of 9 infusions over a~          30-week period.~        -  Blood draws: About 4 tablespoons of blood are drawn at each visit to test for the number~          and types of cells in the blood and to check for signs of inflammation and side effects~          of the study medicine.~      Patients are seen in the NEI clinic for infusions and to check the response to therapy. This~     includes 13 clinic visits over 46 weeks, as follows: every 2 weeks for the first 2 weeks,~     every 4 weeks thereafter for a total of 30 weeks for infusions, and then every 4 weeks for 16~     additional weeks.~      Patients may stop therapy if their scleritis is not controlled 10 weeks into the study~     period; if they develop a flare of inflammation after initial control of the active~     scleritis; if their vision loss is too large; or if their medications increase or other~     medicines are added to control the scleritis. Patients whose vision decreases minimally,~     stays the same, or improves may remain in the study.~   "
266602|NCT00075062|"~     Microbicides are drugs that destroy microbes such as viruses and bacteria. Rectal~     microbicides may be able to prevent transmission of HIV during anal intercourse. The purpose~     of this study is to obtain rectal samples from men to learn information that may be valuable~     in future clinical trials of rectal microbicides.~   "
266603|NCT00075049|"~     This is a double blinded study where 2 test vaccines will be evaluated to see if they protect~     persons who have never had malaria against malaria infection when bitten by mosquitoes.~   "
266604|NCT00014183|"~     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor~     cells and slow the growth of kidney cancer.~      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have~     recurrent or stage IV kidney cancer.~   "
266605|NCT00012116|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have advanced solid tumors that have spread to the brain.~   "
266606|NCT00009919|"~     Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic~     kidney cancer that has not responded to previous therapy with interleukin-2. SU5416 may stop~     the growth of kidney cancer by stopping blood flow to the tumor~   "
266607|NCT00009893|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have unresectable or metastatic biliary tract or gallbladder cancer.~   "
266632|NCT00074880|"~     This study will examine how heart stiffness and a weak atrium affect exercise capacity and~     symptoms in patients with hypertrophic cardiomyopathy (HCM). The atrium is the booster~     pumping chamber of the heart that helps the ventricle (main pumping chamber), to fill~     properly. HCM is an inherited disease in which the ventricle becomes thickened and, in some~     patients, stiff. The stiffness makes it difficult for the ventricle to fill and empty,~     causing breathing difficulty, fatigue, and reduced exercise capacity. Scar formation and a~     weakened atrium can cause the heart to stiffen. Information gained from this study may guide~     doctors in prescribing medicines to reduce scarring or improve atrial function.~      Patients 21 years of age and older with hypertrophic cardiomyopathy may be eligible for this~     study. Candidates will be screened with a medical history and physical examination,~     electrocardiogram (EKG), blood tests, Holter monitor, and echocardiogram. A Holter monitor is~     a device about the size of a Walkman that is connected to three wires that are attached to~     the chest. It is worn for 24 hours to provide continuous monitoring of heart rhythm. An~     echocardiogram uses a small probe that emits sound waves to produce images of the heart. The~     probe is moved across the chest and the reflection of the sound waves from the chambers of~     the heart produce images showing the heart's thickness and function.~      Participants will undergo the following tests and procedures over 3 days:~        -  Physical examination and echocardiogram.~        -  Intravenous cannula insertion: A plastic tube is inserted into an arm vein for~          collecting blood samples to measure substances that the heart and circulatory system~          release at rest and during exercise.~        -  Impedance cardiography: A small current of electricity is passed across the chest and~          electrodes similar to those used for an EKG test are placed to measure blood flow in the~          area of the current.~        -  Pulmonary artery catheterization: A catheter (plastic tube) is inserted into a vein~          either in the arm, under the collarbone, or in the neck and advanced to the right atrium~          and ventricle. The catheter remains in place during the echocardiogram tilt and bicycle~          exercise tests (see below).~        -  Echocardiogram tilt test: The patient lies flat on a table. After a few minutes, the~          table is tilted so that the patient's head is just above his or her feet for a short~          while, then is positioned flat again, and then tilted so the feet are just above the~          head. Echocardiographic measurements and blood samples are taken at intervals to examine~          heart function during changes in posture.~        -  Echocardiogram bicycle stress test: The patient exercises for as long as possible on a~          bicycle-like machine while lying on his or her back. Echocardiographic measurements and~          blood samples are taken at intervals during the test.~        -  Treadmill stress test: The patient runs for as long as possible on a treadmill that~          increases in difficulty. The patient wears a facemask or mouthpiece through which small~          amounts of gases are added in order to measure the ability of the heart and lung to~          increase their effectiveness with exercise.~        -  Digoxin loading: Only patients who demonstrate limited exercise capacity and for whom~          digoxin is not a risk will undergo this procedure. A medicine that makes the heart~          contract more strongly, digoxin is used to treat certain heart abnormalities. Patients~          are given doses of either digoxin or placebo (a look-alike injection with no active~          ingredient) at 4-hour intervals over a 24-hour period and then repeat the tilt test and~          the bicycle and treadmill exercise tests~   "
266664|NCT00074529|"~     An investigational drug (MK0677) will be studied to determine whether it helps the memory and~     cognition of patients with Alzheimer's Disease.~   "
266665|NCT00005598|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Amifostine may improve blood counts in patients with~     myelodysplastic syndrome. Combining azacitidine with amifostine may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of azacitidine plus amifostine in treating~     patients who have myelodysplastic syndrome.~   "
266608|NCT00075036|"~     This study will examine communication and trust between patients in the kidney transplant~     process and their health care providers. It will assess patients' perception of trust in~     their physician and nurse coordinator; determine the patients' level of trust in the areas of~     competence, compassion, control, communication, and confidentiality; and determine how the~     trust level varies as patients progress in the transplant process.~      Patients 18 years of age and older who are in various stages of the kidney transplant process~     at Walter Reed Army Medical Center and the NIH Clinical Center may be eligible for this~     study. Candidates include individuals who:~        -  are on dialysis but not on a transplant waiting list~        -  are on the organ waiting list and are also on dialysis~        -  are on the organ waiting list but are not on dialysis~        -  have had a kidney transplant within the last year.~      Participants will be interviewed by someone who is not their direct health care provider~     about the doctor/patient, primary provider/patient, or nurse/patient relationship, their~     health history, medical condition, and ideas about their care. With the patient's permission,~     parts of the interview will be tape-recorded. The interview will take about 30 to 40 minutes.~   "
266609|NCT00075023|"~     This study was designed to be conducted in 2 parts. The first part is a pilot study to test~     the effects of topical thalidomide gel 20mg applied to up to 3 oral ulcers in patients who~     have developed oral chronic graft-versus-host-disease (cGVHD)-related ulcerative stomatitis~     following allogeneic bone marrow/peripheral blood stem cell transplant (HSCT). Chronic GVHD~     may be related to increased levels of a cytokine called TNF-alpha (TNFa) following HSCT.~     Thalidomide's anti-inflammatory effects may lower TNFa levels, lead to healing of these oral~     ulcers, and decrease oral pain.~      If the pilot study is successful, the second part of the study will be done. This will test~     the effects of a 0.1% (20mg) thalidomide mouthwash in treating oral cGVHD-related stomatitis~     in patients following allogeneic HSCT. Applying thalidomide directly to the GVHD-related~     mouth ulcer in gel form or to the entire oral cavity in mouthwash form rather than taking it~     in pill form may reduce the amount of drug that enters the blood stream and cause less side~     effects.~      In the pilot study, participants will be randomly assigned to receive thalidomide gel 20mg or~     placebo (identical gel with no thalidomide) to use 4 times a day for 4 weeks. In the~     mouthwash study, participants will be randomly assigned to receive 0.1% 20mg thalidomide~     mouthwash or placebo (identical mouth rinse with no thalidomide) to use 4 times a day for 4~     weeks. Participants will undergo the following procedures before beginning experimental~     treatment, then once a week for 4 weeks, and then approximately 8 weeks after the first~     visit:~        -  Interview about current medications and use of alcohol and cigarettes~        -  Self-report of mouth and throat pain~        -  Oral examination for stomatitis rating, and oral ulcer(s) measurement~        -  Quality of life questionnaire (repeated only at week 8 of the study)~        -  Mouth photography to measure and record the oral ulcer response to treatment~        -  Saliva sampling to look for proinflammatory cytokines (small proteins), including TNFa~        -  Oral ulcer exudate collected by filter paper to obtain fluid for measuring TNFa levels~        -  Gentle swabbing of oral ulcers to culture for virus, fungus, and bacteria that may be~          present~        -  Small punch biopsy of the area near the ulcer or affected area to check for presence of~          TNFa (repeated only at week 4 of the study)~        -  Blood sampling to monitor TNFa levels~        -  A urine pregnancy test for women who are able to have children (repeated at weeks 2, 4,~          and 8)~   "
266610|NCT00075010|"~     Valproic acid is a medication that is currently used in the prevention of seizures, bipolar~     disorder, and migraine headaches. Researchers hope that it may improve the effects of~     decitabine. Decitabine is a chemotherapy drug with known activity in leukemia and~     myelodysplastic syndromes.~   "
266611|NCT00074997|"~     The purpose of this study is to determine the safety and efficacy of administration of a~     cell-delivered ribozyme gene transfer product to participants with chronic (lasting a long~     time) Human Immunodeficiency Virus Type 1 (HIV-1) infection (a life-threatening infection~     which you can get from an infected person's blood or from having sex with an infected~     person).~   "
266612|NCT00009867|"~     Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have~     recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that~     have become resistant to standard chemotherapy regimens.~   "
266613|NCT00009698|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill more cancer~     cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating children who~     have undergone bone marrow transplantation for acute myeloid leukemia.~   "
266614|NCT00006481|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, but may cause~     skin irritation and inflammation. Biafine cream may be effective in lessening side effects~     caused by radiation therapy.~      PURPOSE: Randomized phase III trial to determine the effectiveness of Biafine cream in~     reducing side effects of radiation therapy in patients receiving treatment for head and neck~     cancer.~   "
266615|NCT00006480|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cell from growing. Inserting genetic material made in the laboratory into a person's~     blood cells may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of biological therapy and gene therapy in~     treating children who have recurrent or refractory neuroblastoma.~   "
266616|NCT00074984|"~     People with Fabry disease have an alteration in their genetic material (DNA) which causes a~     deficiency of the a-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps~     to breakdown and remove certain types of fatty substances called glycolipids. These~     glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids~     build up in various tissues such as the liver, kidney, skin, and blood vessels because~     a-galactosidase A is not present, or is present in small quantities. The build up of~     glycolipid (globotriaosylceramide or GL-3) levels in these tissues in particular is~     thought to cause the clinical symptoms that are common to Fabry disease. This study will test~     the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease.~   "
266617|NCT00074971|"~     People with Fabry disease have an alteration in their genetic material (DNA) which causes a~     deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and~     remove certain types of fatty substances called glycolipids. These glycolipids are normally~     present within the body in most cells. In Fabry disease, glycolipids build up in various~     tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not~     present, or is present in small quantities. The build up of glycolipid~     (globatriaosylceramide or GL-3) levels in these tissues in particular is thought to cause~     the clinical symptoms that are common to Fabry disease. This study will test the safety and~     efficacy of Fabrazyme in the treatment of patients with Fabry disease.~   "
266661|NCT00005642|"~     RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have~     advanced solid tumors.~   "
266662|NCT00005634|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in~     treating patients who have advanced primary or metastatic solid tumors that have not~     responded to previous therapy.~   "
266618|NCT00074958|"~     People with Fabry disease have an alteration in their genetic material (DNA) which causes a~     deficiency of the a-galactosidase A enzyme. This enzyme helps to break down and remove~     certain types of fatty substances called glycolipids. These glycolipids are normally~     present within the body in most cells. In people with Fabry disease, glycolipids build up in~     various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A~     is not present, or is present in small quantities. The build up of glycolipid levels (also~     referred to as globotriaosylceramide or GL-3) in these tissues is thought to cause the~     clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood~     with pain in the hands and feet. This study explored the safety, efficacy and~     pharmacokinetics of Fabrazyme in pediatric patients aged between 7 and 15 years.~   "
266619|NCT00074932|"~     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The objective of this protocol is to provide enzyme replacement therapy with~     alglucosidase alfa on an expanded access basis, to severely affected patients with late-onset~     Pompe disease for whom there is no alternative treatment and who do not meet the clinical~     characteristics described in the inclusion criteria for participation in other Genzyme~     Corporation-sponsored studies currently enrolling patients with late-onset Pompe disease.~   "
266620|NCT00074919|"~     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a~     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the~     body's cells to break down glycogen (a stored form of sugar) within specialized structures~     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates~     and is stored in various tissues, especially heart and skeletal muscle, which prevents their~     normal function. The objective of this protocol is to provide enzyme replacement therapy with~     rhGAA on an expanded access basis, to severely affected patients with infantile-onset Pompe~     disease for whom there is no alternative treatment and who do not meet the clinical~     characteristics described in the inclusion criteria for participation in other Genzyme~     Corporation-sponsored study currently enrolling patients with infantile-onset Pompe disease.~   "
266621|NCT00074906|"~     Study to demonstrate that administration of Venticute increases survival of patients with~     pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation,~     and severe oxygenation impairment.~   "
266622|NCT00074945|"~     This study will explore factors that affect obesity and obesity-related diseases in both~     Caucasians and African Americans. By looking at the rate at which the human body burns~     calories while at rest (resting energy expenditure, or REE) and at the rate at which fat~     travels through the blood (fatty acid flux), this study will examine the relationship between~     REE and fatty acid flux, both of which are determinants of obesity. Researchers will compare~     the test results of Caucasians and African Americans to determine if race has an effect on~     the relationship between REE and fatty acid flux.~      Volunteers must be between 18 and 49 years of age. Equal numbers of typical weight,~     overweight, and obese participants will be recruited. Candidates will be screened with a~     physical examination, electrocardiogram, and blood tests, and will be interviewed about diet~     and exercise habits, family and medical history, and employment.~      Participants will be placed on a two-week maintenance diet (prepared by a dietician to~     regulate and maintain calorie consumption) and must visit an outpatient clinic for weight~     measurement for 10 consecutive weekdays. During the two-week diet, participants will also~     undergo two 20-minute computerized scans to measure abdominal and body fat. At the end of the~     two weeks, participants will then be hospitalized for two days to allow researchers to~     conduct blood tests, oral glucose tests, and a physical examination to measure REE and fatty~     acid flux levels for comparison.~   "
266623|NCT00074893|"~     When people use hand-held power tools, their hands and arms vibrate along with the tool they~     are holding. People who frequently use hand-held power tools may develop injuries related to~     this vibration. This study will evaluate a protective brace designed to prevent~     vibration-related hand and arms injuries.~   "
266624|NCT00074867|"~     The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase~     inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal~     serous cancer, or fallopian tube cancer for patients who have failed first line~     platinum-based therapy and have a persistent rising CA-125.~   "
266625|NCT00074854|"~     The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase~     inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is~     effective in the treatment of advanced stage non-small cell lung cancer.~   "
266626|NCT00074841|"~     This primary objective of this study is to assess whether the combination of Azithromycin~     with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus~     chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum~     in adults in India.~   "
266627|NCT00006384|"~     RATIONALE: SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor.~     Interferon alfa-2b may interfere with the growth of the cancer cells. Combining interferon~     alfa-2b with SU5416 may be an effective treatment for kidney cancer.~      PURPOSE: Phase II trial to study the effectiveness of combining SU5416 and interferon alfa-2b~     in treating patients who have unresectable or metastatic kidney cancer.~   "
266628|NCT00006353|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known if radiation therapy is more effective with or without temozolomide~     for glioblastoma multiforme.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.~   "
266629|NCT00006247|"~     RATIONALE: SU5416 may stop the growth of brain cancer cells by stopping blood flow to the~     tumor.~      PURPOSE: Phase I trial to study the safety of delivering SU5416 in children who have~     recurrent or progressive brain tumors.~   "
275450|NCT00000201|"~     The purpose of this study is to conduct human laboratory studies of possible cocaine~     interactions with various potential treatment medications.~   "
266633|NCT00074828|"~     LY517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from~     forming in the legs and may prevent those blood clots from traveling to the lungs. Leg and~     lung blood clots occur commonly after patients have surgery to replace a hip or knee joint.~     These clots often occur while patients are in bed in the hospital after hip or knee joint~     surgery. The purpose of this study is to test if different dose strengths (amount of drug in~     the capsules) of LY517717 can prevent blood clots from forming and to determine if LY517717~     is safe. This study will compare LY517717 to enoxaparin, another blood thinner. Enoxaparin is~     one of the standard medications given after hip or knee joint surgery.~   "
266634|NCT00074763|"~     Objectives:~        -  Determine the corrected count increment of autologous transfused platelets that had been~          stored by cryopreservation with ThromboSol.~        -  Determine the ability of autologous platelets that had been stored by cryopreservation~          with ThromboSol to correct thrombocytopenia.~   "
266635|NCT00074750|"~     DTGM belongs to a new generation of drugs designed to target leukemic cells. To achieve this,~     DTGM takes advantage of the ability of naturally-produced growth factor (GM,~     granulocyte-macrophage stimulating factor) to deliver a drug (diphtheria toxin) to cells;~     preferably leukemic cells. It then attaches to the cells and allows the toxin to enter the~     leukemic cells and destroy them.~   "
266636|NCT00074737|"~     The principal goal of this clinical trial is to assess the ability of cenersen sodium (EL625)~     to improve cancer responsiveness to the established AML therapeutic agent Idarubicin used~     alone or in combination with Cytarabine (Ara-C).~      Cenersen sodium is a drug that is designed to block the effects of a protein called p53.~     Laboratory evidence shows that blocking p53 will make many types of cancer, including acute~     myelogenous leukemia (AML), more sensitive to a variety of established cancer therapeutics~     while making normal tissues more resistant to the toxic effects of these agents.~   "
266637|NCT00074724|"~     To define the role of the assessment of myocardial viability with dobutamine echocardiography~     (DE) in the clinical evaluation and selection of the best treatment for a high-risk subset of~     patients with coronary artery disease.~   "
266638|NCT00006099|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Giving monoclonal antibodies~     in different ways may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have ovarian cancer.~   "
266639|NCT00006087|"~     RATIONALE: Diagnostic procedures such as chest x-ray and chest CT scans may be effective in~     early detection of lung cancer.~      PURPOSE: Randomized clinical trial to compare the effectiveness of a chest CT scan given once~     a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a~     high-risk of developing lung cancer.~   "
266640|NCT00006080|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who~     have recurrent malignant glioma.~   "
266641|NCT00005978|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor~     cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell~     or bone marrow transplantation may be able to replace immune cells that were destroyed by~     chemotherapy or radiation therapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of combination~     chemotherapy when given before stem cell transplant and radiation therapy in treating~     patients with neuroblastoma that has not responded to previous treatments.~   "
266642|NCT00005963|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in~     treating women who have metastatic breast cancer.~   "
266643|NCT00074815|"~     This study will determine whether cognitive behavioral therapy delivered by either~     psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor~     treatment in children with obsessive compulsive disorder.~   "
266644|NCT00074802|"~     This study will examine whether the addition of cognitive behavioral therapy can improve the~     efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety~     disorder. Patients with social anxiety disorder will undergo a 12-week open trial with~     paroxetine. Those who complete the open trial having achieved only partial response will be~     randomized to receive cognitive behavioral therapy (CBT) in addition to paroxetine or to~     continue on paroxetine alone for an additional 16 weeks.~   "
266645|NCT00074789|"~     This study will test the effectiveness of a short-term intervention in treating depressed~     young mothers with young children enrolled in Early Head Start Programs.~   "
266646|NCT00074776|"~     This study will compare the medications lithium and lamotrigine (Lamictal®) in treating~     depression in individuals with bipolar II disorder.~   "
266647|NCT00074711|"~     Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two~     minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly~     prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus~     available for bone building. Teriparatide is a drug that reduces the risk of fractures by~     increasing bone thickness and strength. Vitamin D is also necessary for strong bones and~     teeth. The purpose of this study is to evaluate the bone-building effectiveness of two~     calcium supplements, one with a source of phosphorus and one without, in combination with~     teriparatide and vitamin D in women with osteoporosis.~   "
266648|NCT00074698|"~     The purpose of this study is to evaluate the safety and tolerability of FG-3019, a~     therapeutic antibody designed to block the pro-fibrotic activity of connective tissue growth~     factor (CTGF). CTGF triggers the production of collagen and fibronectin, which cause scarring~     and thickening of the lungs. Approximately 18 to 27 males and females, 21 to 80 years of age~     with a diagnosis of idiopathic pulmonary fibrosis (IPF) will be enrolled in this study. The~     duration of the study is approximately one month, during which patients will receive a single~     infusion of FG-3019. In addition, there will be two follow-up visits 6 and 12 months after~     receiving the study drug.~   "
266649|NCT00074685|"~     The ichthyoses are a family of genetic skin diseases characterized by dry, thickened, scaling~     skin. Dermatologists estimate that there are over twenty varieties of ichthyosis, with a wide~     range of severity and associated symptoms. This registry is designed to identify people in~     the United States with the ichthyoses and other related disorders and to collect information~     about their skin ailment and how it has affected them. The database is available for review~     by approved research applicants. The registry is confidential and provides investigators a~     way to share information about studies and trials with potential participants while~     maintaining participants' privacy.~      Although the Registry is closed to new enrollment, it is still maintained in order to provide~     information related to understanding the diagnosis, pathophysiology, and treatment of~     ichthyoses. Support for studies continues and inquiries from investigators are welcomed.~   "
266650|NCT00074646|"~     Phase I trial of CC-8490 for the treatment of subjects with recurrent/refractory high-grade~     gliomas~   "
266651|NCT00074633|"~     Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of~     their size, experience a life-long battle and preoccupation with their weight. Despite the~     attention to weight and the increase in diet behavior, the incidence of obesity continues to~     rise. There is little data to show improved long term success for the majority of~     participants who engage in weight loss behaviors.~      The specific aim is to improve the psychological and metabolic health of obese women with a~     history of chronic dieting through encouraging Health at Every Size (HAES). This treatment~     model emphasizes intutitive eating, i.e., internal regulation of eating (responding to cues~     of hunger, appetite and satiety). The HAES model is being compared to the current standard of~     care in obesity treatment, energy restriction dieting, which encourages cognitive control of~     eating and weight reduction.~   "
266652|NCT00074620|"~     The study will look at the safety profile (unwanted effects) of the long-lasting~     anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of~     unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of~     the haemodialysis machine.~   "
266653|NCT00074672|"~     This study will explore what occurs between sensory and motor systems in restless legs~     syndrome (RLS). Patients with RLS have uncomfortable sensations in the legs, usually in the~     evening or early part of the night. Most patients also have periodic involuntary leg~     movements. The condition tends to worsen over time, resulting in severe discomfort and sleep~     disturbances.~      Healthy normal volunteers and patients with RLS between 18 and 80 years of age may be~     eligible for this study. All candidates will be screened with a medical history, physical and~     neurological evaluations, electroymogram (measure of muscle activity), overnight sleep study,~     electrocardiogram (ECG, measurement of the electrical activity of the heart), and blood and~     urine tests. They may also have brain or spine magnetic resonance imaging (MRI) or~     computerized tomography (CT) scans and a chest X-ray. Participants must stop taking all~     medications prohibited by the study for 2 days or more before the study starts and throughout~     its duration.~      Participants will undergo prepulse inhibition tests to assess nervous system function. The~     participant sits comfortably in a quiet room. Several cables are attached to the face and~     legs using a special cream that conducts electrical signals through the cables to recording~     equipment. Nervous system activity is evaluated while the subject is at rest and after~     sensory stimulation (stimulating the nerves in the legs and face with a very brief electrical~     current of mild to moderate intensity). At times, the subject receives a short, mild sound~     stimulation delivered through earphones. The testing session takes 4 to 6 hours.~   "
266654|NCT00074607|"~     Subject's are being asked to take part in this study because he or she has a type of cancer~     that has spread to the meninges (tissues that cover the brain and spinal cord).~      There is no known effective treatment for this specific disease or the subject has received~     all of the treatments that are known to work for his or her specific disease without success.~     Currently, there is no other effective treatment for this type of cancer.~      The purposes of this study are:~        -  to determine the highest dose of gemcitabine, an anti-cancer drug, that can safely be~          given directly into the spinal fluid of children and adults whose cancer no longer~          responds to standard treatment;~        -  to find out what effects (good and bad) gemcitabine has when given directly into the~          cerebrospinal fluid (called intrathecal administration) in children and adults with~          neoplastic meningitis (cancer that has spread to the lining of the brain and spinal~          cord);~        -  to determine if gemcitabine is beneficial to the patient;~        -  to understand how gemcitabine is handled by the body after intrathecal administration.~   "
266655|NCT00074581|"~     This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV~     among couples in which one partner is HIV infected and the other is not.~   "
266656|NCT00074568|"~     Scleroderma is likely caused by a combination of factors, including an external trigger~     (infection or other exposure) and a genetic predisposition. The Scleroderma Registry will~     conduct genetic analyses for disease-related genes in patients with scleroderma and their~     family members (parents, brothers, and sisters).~   "
266657|NCT00074555|"~     The purpose of this study is to better understand the causes of rheumatoid arthritis (RA),~     particularly in African Americans.~   "
266658|NCT00005959|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining more than one chemotherapy drug with rituximab may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab plus combination chemotherapy~     in treating patients who have intermediate-grade or high-grade non-Hodgkin's lymphoma.~   "
266659|NCT00005876|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have locally advanced or metastatic stomach cancer that cannot be removed during surgery.~   "
266660|NCT00005646|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who~     have extensive-stage small cell lung cancer.~   "
266666|NCT00005592|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radiation to~     them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab and ibritumomab tiuxetan in~     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.~   "
266667|NCT00005083|"~     RATIONALE: New imaging procedures, such as functional magnetic resonance imaging and~     1H-nuclear magnetic resonance spectroscopic imaging, may improve the ability to detect the~     extent of cancer in the brain.~      PURPOSE: Phase II trial to study the effectiveness of functional magnetic resonance imaging~     and 1H-nuclear magnetic resonance spectroscopic imaging in treating patients who have newly~     diagnosed brain tumors.~   "
266668|NCT00004890|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer~     cells. Biomed 101 may protect normal cells from the side effects of interleukin-2.~      PURPOSE: Phase I trial to study the effectiveness of Biomed 101 in treating patients~     receiving interleukin-2 for kidney cancer.~   "
266669|NCT00004874|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in~     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.~   "
266670|NCT00074516|"~     This study will test the effectiveness of a combination of anti-rejection medicines in~     preventing complications typically seen in cystinosis patients undergoing kidney transplants.~     Cystinosis is a rare disease affecting children that causes growth retardation and kidney~     failure. Kidney transplant is the standard treatment for kidney failure in these patients,~     followed by immunosuppression to prevent organ rejection. The standard drug regimen for~     immunosuppression includes steroids, which can lead to other serious complications. This~     study will look at combination therapy that does not include steroids.~      Patients 7 years of age and older with cystinosis who are candidates for a kidney transplant~     at the National Institutes of Health Clinical Center may be eligible for this 5-year study.~     Candidates will be screened with a medical history, physical examination, and blood tests.~      Participants will undergo the following tests and procedures:~        1. Kidney transplant: Patients undergo kidney transplant surgery under general anesthesia.~        2. Central line placement: A large intravenous catheter (plastic tube, or IV line) is~          placed in a vein in the chest or neck under local anesthesia before the transplant~          surgery. The line remains in place for some time during the hospitalization to~          administer immunosuppressive medications, antibiotics, and blood, if needed. The line is~          also used to collect blood samples.~        3. Leukapheresis: This procedure for collecting white blood cells is done before the~          transplant. The cells are studied to evaluate the patient's immune system. Whole blood~          is withdrawn through a catheter in an arm vein or through the central line and directed~          into a machine that separates the blood components by spinning. The white cells are~          removed and the red cells and plasma are returned to the body.~        4. Immunosuppressive medication following transplantation~             -  Adults receive thymoglobulin at the time of the transplant and for 3 days after~               surgery; mycophenolate mofetil daily after the transplant; tacrolimus twice a day~               once the kidney is working well; and sirolimus daily.~             -  Children receive daclizumab the day of the transplant, day 4 after surgery, and at~               weeks 2, 4, 6, 8, 11, 15, 19, and 23, and mycophenolate mofetil daily after the~               transplant.~        5. Follow-up visits: After discharge from the hospital, patients return to the Clinical~          Center for follow-up at 6 months, at 1 year, and then yearly for 5 years. A physical~          examination is done the first four visits, and blood and urine samples are collected at~          every visit. Kidney biopsies (removal of a small amount of kidney tissue through a thin~          needle) are done at 6 months, 1, 3, and 5 years after the transplant. The biopsied~          tissue is examined to evaluate how well the kidney is responding to the~          immunosuppression medicines, to determine whether more or less medication is needed, and~          to evaluate how the patient is responding to the donor kidney.~        6. Routine laboratory tests, coordinated by the patient's local physician, are done 2 to 3~          times a week for the first 2 to 3 months after transplantation, then weekly for several~          more months, and at least monthly for life.~   "
266671|NCT00074503|"~     This study will examine the use of positron emission tomography (PET) for measuring~     docosahexaenoic acid (DHA) absorption from the blood into the brain. DHA is a type of fatty~     acid found in fish and other seafood. It is involved in brain cell activity that underlies~     the ability to think, move, and respond to the outside world. When the amount of DHA in the~     brain is low, the brain may not work the same as if there were a normal amount of DHA. If PET~     can be used successfully to evaluate brain DHA metabolism, this method might be useful for~     future studies of alcoholism, since brain DHA levels are influenced by alcohol consumption.~      Healthy normal volunteers between 18 and 65 years of age may be eligible for this study.~     Because study participants must stop taking any medications, including herbal preparations,~     individuals who require regular medication are excluded from this protocol. Participants will~     undergo the following tests and procedures:~        -  Psychological questionnaires concerning thoughts and behaviors.~        -  Nutritional status analysis: A dietitian will assess the subject's nutritional status~          through questionnaires and measurement of body fat. Body fat is measured using~          bioelectrical impedance analysis. This analysis uses a low, safe electric current to~          measure body composition, giving a reading of the percentage of fat in the body.~        -  Fat biopsy to measure the composition of fat tissue: An area on the upper half of the~          buttock will be numbed and a needle will be inserted to aspirate a sample of fat tissue~          for analysis.~        -  Blood drawing: Blood samples will be collected at the time of the fat biopsy and the PET~          scan (see below) to measure DHA and indicators that may influence DHA.~        -  Diet: 3 days before the fat biopsy and at least 3 days before the PET scan, subjects~          will consume a diet low in DHA and other omega-3 fats. This no seafood diet prohibits~          eating fish, shellfish, seaweed, seafood, health food products or supplemental vitamins,~          and foods containing canola or flaxseed oil. Caffeine-containing beverages are limited~          to one per day for 3 days before the study. Alcoholic beverages are prohibited for 2~          weeks before the study. For 24 hours before the PET scan, subjects eat only standard~          meals that will be provided to them.~        -  Magnetic resonance imaging: A brain MRI scan will be done to fit the PET scan images~          onto a picture of the whole brain. During the scan, the subject lies on a table inside a~          narrow metal cylinder containing a strong magnetic field.~        -  PET scan: Before the PET scan, catheters (small plastic tubes) are inserted into an arm~          vein and into a wrist artery. The venous catheter is used for injecting a radioactive~          substance that will be detected by the scanner, and the arterial catheter is used for~          collecting blood samples during the scan. For the scan, the subject lies on a bed that~          slides into the doughnut-shaped scanner. A mask is placed to keep the head still. A~          transmission scan is done to see how much radiation the skull absorbs. Radioactive water~          (15O-water) is then injected into the blood, and the brain is scanned for about 10~          minutes to measure brain blood flow. Then, radioactive DHA (11C-DHA) is injected,~          followed by about 1-1/2 hours of scanning to measure DHA absorption into the brain.~   "
266672|NCT00074490|"~     Background:~      Patients with cancers of the blood and immune system often benefit from transplants of stem~     cells from a genetically well-matched sibling. However, severe problems may follow these~     transplants because of the high-dose chemotherapy and radiation that accompany the procedure.~     Also, donated immune cells sometimes attack healthy tissues in a reaction called~     graft-versus-host disease (GVHD), damaging organs such as the liver, intestines and skin. To~     reduce toxicity of high-dose preparative chemotherapy, this study performs allogeneic~     transplant after low doses of chemotherapy. In an attempt to improve anti-tumor effects~     without increasing GVHD, this study uses donor immune cells (Th2 cells) grown in the~     laboratory; some patients will receive standard donor immune cells (not grown in laboratory).~     All patients will receive immune modulating drugs sirolimus and cyclosporine to prevent GVHD.~      Objective:~      To determine the safety, treatment effects and rate of GVHD in patients receiving transplants~     that use low-intensity chemotherapy, sirolimus plus cyclosporine, and transplant booster with~     either Th2 cells or standard immune cells.~      Eligibility:~      Patients 16 to 75 years of age with acute or chronic leukemia, non-Hodgkin's lymphoma,~     Hodgkin's disease, multiple myeloma, or myelodysplastic syndrome.~      Patients must have a suitable genetically matched sibling donor and adequate kidney, heart~     and lung function.~      Design: The protocol has three treatment groups: cohort 1, Th2 booster at two weeks~     post-transplant; cohort 2, standard T cell booster at two weeks post-transplant; cohort 3,~     multiple infusion of Th2 cells.~      Condition<TAB>Hematologic Neoplasms, Myeloproliferative Disorders~      Intervention<TAB>Biological; therapeutic allogeneic lymphocytes~      <TAB><TAB>Drug: Sirolimus~      Study Type:<TAB> Interventional~      Study Design:<TAB>Primary Purpose: Treatment~      Phase:<TAB><TAB>Phase II~   "
266673|NCT00074477|"~     The purpose of this study is to determine the efficacy (how well the drug works), safety, and~     side effects of paliperidone palmitate injection compared to placebo in the treatment of the~     symptoms of schizophrenia in adults. The placebo used in this study was a nutritional~     substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.~   "
266674|NCT00074464|"~     To investigate the predictive value of using measures of cholesterol homeostasis to identify~     individuals at high risk of developing cardiovascular disease relative to established risk~     factors.~   "
266675|NCT00074451|"~     To identify the genes involved in the metabolic syndrome.~   "
266676|NCT00074438|"~     This study will assess the efficacy and safety of different treatment regimens of rituximab~     (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in~     patients with active rheumatoid arthritis (RA).~   "
266677|NCT00074425|"~     The majority of HIV infected people worldwide became infected with the virus through~     heterosexual contact. BufferGel and PRO 2000 Gel are vaginal gels designed to prevent women~     from becoming infected with HIV during sexual intercourse with an HIV infected partner. This~     study will test the safety and effectiveness of these gels.~   "
266678|NCT00074412|"~     The many benefits of breastfeeding are well documented. However, because of the risk of~     mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there~     is considerable concern over the practice, especially in developing countries. The purpose of~     this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP)~     in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South~     Africa, Tanzania, Uganda, and Zimbabwe.~   "
266679|NCT00074399|"~     HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The~     purpose of this study is to determine whether giving infants of HIV infected mothers the~     anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.~      Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease~     HIV transmission through breastfeeding.~   "
267649|NCT00039169|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who~     have advanced kidney cancer.~   "
266680|NCT00074386|"~     With improved anti-HIV drug therapy, HIV infected patients are now living longer. These~     patients are at risk for liver and kidney failure and may need organ transplants. However,~     little is know about the safety and effectiveness of organ transplants in patients with HIV.~     This study will evaluate organ transplantation in HIV infected patients undergoing liver and~     kidney transplants.~   "
266681|NCT00074373|"~     Women with lupus and other related disorders produce certain antibodies in the blood. Some~     women have these antibodies even if they have not yet developed symptoms of lupus or~     Sjogren's syndrome. When these women become pregnant, they may pass the antibodies to their~     infants. The infants may then develop a disease called neonatal lupus. The symptoms of~     neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. This~     registry collects information on women and infants affected by neonatal lupus as well as~     other family members who may be healthy.~   "
266682|NCT00021983|"~     RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal cells.~     This may be an effective treatment for hairy cell leukemia.~      PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients~     who have refractory or recurrent hairy cell leukemia.~   "
266683|NCT00008177|"~     This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody~     BC8 when given together with fludarabine phosphate and low-dose total-body irradiation~     followed by donor stem cell transplant and immunosuppression therapy in treating older~     patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that cannot be~     controlled with treatment. Radiolabeled monoclonal antibodies, such as iodine I 131~     monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them.~     Giving chemotherapy, such as fludarabine phosphate, and total-body irradiation before a donor~     peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells. It~     may also stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem~     cells may also replace the patient's immune cells and help destroy any remaining cancer~     cells. Sometimes the transplanted cells from a donor can also make an immune response against~     the body's normal cells. Giving radiolabeled monoclonal antibody therapy together with~     fludarabine phosphate and total-body irradiation before the transplant together with~     cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.~   "
266684|NCT00074360|"~     This study is divided into two parts; each designed to answer a separate but related~     question:~      Which brain regions are activated in humans by the rewarding properties of ethanol~     administration?~      Is it possible to demonstrate a conditioned response to a stimulus paired with rising blood~     alcohol concentrations (BAC) in humans and can this response be observed in the brain using~     functional magnetic resonance images (fMRI) techniques?~      Part 1. In order to determine which brain regions are activated by the rewarding properties~     of ethanol administration, we propose to use Blood Oxygenation Level Dependent (BOLD) fMRI~     techniques to test the hypothesis that during the time of rising and peak BAC, mesolimbic,~     mesocortical, and nigrostriatal dopamine (DA) terminal areas of the brain will show~     significant increases in cerebral blood flow. Healthy, non-alcoholic subjects will be given~     intravenous (IV) ethanol or placebo infusions on separate days. The infusions will have three~     phases. On each day, during the first phase a saline infusion will be used to measure basal~     brain blood flow. The second phase will be an ethanol infusion delivered at rates calculated~     to produce a BAC of 0.08 plus or minus 0.005 g/dl at 10 minutes. The rate of the infusion for~     the next 10 minutes (third phase) will be calculated to maintain BAC at the target level of~     0.08 plus or minus 0.005 g/dl for the duration of the infusion. On the placebo day, subjects~     will receive a saline infusion at the same set of rates for phases two and three as used~     during their ethanol infusion. Continuous multi-slice fMRI data will be collected during each~     infusion.~      Part 2. In order to investigate conditioned response to ethanol, three groups of healthy,~     non-alcoholic subjects will be given a series of IV infusions on separate days. The~     experimental group will receive ethanol infusion paired with a conditioned stimulus (CS)~     which will be presented while the BAC is rising. One control group (I) of healthy,~     non-alcoholic subjects will also be given a series of intravenous ethanol infusions on~     separate days, but these infusions will not be paired with a CS. The other control group (II)~     will be given only saline infusions during the CS presentation. After three training~     sessions, all three groups will undergo an fMRI scan during which the CS will be paired with~     saline infusion. This will allow the response to the CS alone to be observed. After 10~     minutes of CS presentation, the ethanol infusion will begin and continue for another 15~     minutes. Conditioned response (CR) will be demonstrated if the experimental group shows~     greater increase in BOLD signal than the control groups in motivation areas such as~     mesolimbic, mesocortical, and nigrostriatal dopamine (DA) terminal areas of the brain in~     response to the CS while they receive the saline infusion. Control group II will also undergo~     an fMRI scan and will be given saline infusion followed by ethanol infusion during their last~     15 minutes in the scanner to control for the non-specific effects of repeated infusions &~     scans on BOLD response to ethanol. If we are able to produce a CR in brain regions associated~     with motivation, it may be possible to use this CR as an experimental model for human alcohol~     craving.~   "
266685|NCT00074334|"~     RATIONALE: The TP-38 toxin can locate tumor cells and kill them without harming normal cells.~     Giving TP-38 toxin directly into the tumor may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of TP-38 toxin~     administered directly into the brain and to see how well it works in treating young patients~     with recurrent or progressive supratentorial high-grade glioma.~   "
266686|NCT00074321|"~     Drugs used in chemotherapy, such as irinotecan, oxaliplatin, and capecitabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Combining more~     than one chemotherapy drug may kill more tumor cells. This phase I trial is studying the side~     effects and best dose of irinotecan, oxaliplatin, and capecitabine in treating patients with~     unresectable solid tumors.~   "
266687|NCT00074308|"~     Phase II trial to study the effectiveness of combining imatinib mesylate with bevacizumab in~     treating patients who have advanced melanoma or other metastatic or unresectable cancer.~     Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the~     tumor. Combining imatinib mesylate with bevacizumab may kill more tumor cells~   "
266688|NCT00074295|"~     RATIONALE: Vaccines made from a person's tumor tissue may make the body build an immune~     response to kill tumor cells.~      PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating~     patients with stage IIIB or stage IV bronchoalveolar (lung) cancer.~   "
266689|NCT00074282|"~     RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and~     lenalidomide work in different ways to stop cancer cells from dividing so they stop growing~     or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them~     or deliver cancer-killing substances to them without harming normal cells. Combining~     chemotherapy with monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab,~     and lenalidomide work in treating patients with relapsed or refractory B-cell chronic~     lymphocytic leukemia.~   "
266703|NCT00074035|"~     RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by~     stopping the immune system from rejecting donor stem cells or donor white blood cells.~      PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with~     chronic graft-versus-host disease that is refractory (not responsive) to treatment with~     steroids.~   "
266690|NCT00074269|"~     RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral~     blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's~     immune system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune system and help destroy any remaining tumor cells (graft-versus-tumor~     effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the~     transplant may help increase this effect. Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving antithymocyte globulin,~     cyclosporine, and methotrexate before or after the transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well antithymocyte globulin, high-dose~     melphalan, fludarabine, and allogeneic peripheral stem cell transplant work in treating~     patients with metastatic adenocarcinoma of the breast.~   "
266691|NCT00074243|"~     RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have~     recurrent or refractory high-grade gliomas.~   "
266692|NCT00074230|"~     RATIONALE: Vaccines made from a person's dendritic cells and antigens may make the body build~     an immune response to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous~     dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma.~   "
266693|NCT00074204|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining more~     than one drug may kill more tumor cells. It is not yet known which treatment regimen is more~     effective for stage IIIB or stage IV non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine and~     carboplatin followed immediately by docetaxel with that of giving delayed docetaxel in~     treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
266694|NCT00074191|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate, procarbazine, lomustine,~     dexamethasone, and cytarabine, use different ways to stop cancer cells from dividing so they~     stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have primary CNS lymphoma.~   "
266695|NCT00074178|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, etoposide~     phosphate, dexamethasone, and cytarabine, work in different ways to stop cancer cells from~     dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain~     drugs to open the blood vessels around the brain and allow anticancer substances to be~     delivered directly to the brain. Giving methotrexate, cyclophosphamide, and etoposide~     phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine may~     kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of giving methotrexate, cyclophosphamide,~     and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and~     cytarabine in treating patients who have primary CNS lymphoma.~   "
266696|NCT00074165|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and~     cytarabine, use different ways to stop cancer cells from dividing so they stop growing or~     die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels~     around the brain and allow anticancer substances to be delivered directly to the brain tumor.~     Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side~     effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with~     osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination~     chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in~     treating patients who have refractory or recurrent primary CNS lymphoma.~   "
266697|NCT00074152|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether chemotherapy is effective in treating~     women who have undergone surgery and radiation therapy for relapsed breast cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy~     in treating women who have undergone resection for local and/or regional relapsed breast~     cancer.~   "
266698|NCT00074139|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and cyclophosphamide,~     use different ways to stop tumor cells from dividing so they stop growing or die. Combining~     more than one drug and giving them at different times, may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective for breast cancer.~      PURPOSE: Randomized phase I trial to compare the effectiveness of two regimens of docetaxel~     combined with doxorubicin and cyclophosphamide in treating women who have advanced breast~     cancer.~   "
266699|NCT00074100|"~     RATIONALE: Drugs used in chemotherapy, such as amonafide, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of amonafide in treating women who have~     metastatic breast cancer that has progressed after previous chemotherapy.~   "
266700|NCT00074087|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to~     stop cancer cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating~     patients who have stage IIB, stage IVA, or stage IVB recurrent or refractory mycosis~     fungoides.~   "
266701|NCT00074074|"~     RATIONALE: Monoclonal antibodies, such as infliximab, can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of infliximab in treating~     patients who have myelodysplastic syndrome.~   "
266702|NCT00074048|"~     RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal~     cells. This may be an effective treatment for hairy cell leukemia that has not responded to~     treatment with cladribine.~      PURPOSE: This phase II trial is studying BL22 immunotoxin to see how well it works in~     treating patients previously treated with cladribine for hairy cell leukemia.~   "
266704|NCT00074022|"~     Phase I/II trial to study the effectiveness of combining GTI-2040 with docetaxel in treating~     patients who have recurrent, metastatic, or unresectable locally advanced non-small cell lung~     cancer, prostate cancer, or other solid tumors. GTI-2040 may stop the growth of cancer cells~     by blocking the enzymes necessary for their growth. It may also increase the effectiveness of~     docetaxel by making the tumor cells more sensitive to the drug. Combining GTI-2040 with~     docetaxel may kill more tumor cells~   "
266705|NCT00074009|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth.~      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who~     have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.~   "
266706|NCT00073983|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine~     with docetaxel may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in~     treating patients who have recurrent osteosarcoma, recurrent Ewing's sarcoma, or unresectable~     or locally recurrent chondrosarcoma.~   "
266707|NCT00073970|"~     RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by~     blocking the enzymes necessary for tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have~     relapsed prostate cancer following radiation therapy or radical prostatectomy.~   "
266708|NCT00073957|"~     RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab,~     can locate cancer cells and either kill them or deliver radioactive cancer-killing substances~     to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with~     rituximab may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab~     tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large~     B-cell non-Hodgkin's lymphoma.~   "
266709|NCT00073944|"~     RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for~     their growth.~      PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have~     refractory cancer.~   "
266710|NCT00073931|"~     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate~     cancer cells and deliver radioactive cancer-killing substances to them without harming normal~     cells. Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation~     may be an effective treatment for non-Hodgkin's lymphoma.~      PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with~     autologous stem cell transplantation in treating older patients who have relapsed or~     refractory non-Hodgkin's lymphoma.~   "
266711|NCT00073918|"~     This phase II trial is studying how well giving iodine I 131 tositumomab together with~     etoposide and cyclophosphamide followed by autologous stem cell transplant works in treating~     patients with relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal~     antibodies, such as iodine I 131 tositumomab, can find cancer cells and deliver radioactive~     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy,~     such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Combining a~     radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell~     transplant may kill more cancer cells~   "
266712|NCT00073905|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, use different~     ways to stop tumor cells from dividing so they stop growing or die. Palliative chemotherapy~     may improve the quality of life in patients who have locally advanced or metastatic biliary~     tract cancer and may help them live more comfortably.~      PURPOSE: Phase II trial to study the effectiveness of adjuvant capecitabine and gemcitabine~     in improving quality of life in patients who have locally advanced or metastatic biliary~     tract cancer.~   "
266713|NCT00073892|"~     RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor.~      PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have~     an advanced malignancy (cancer) or stage IV melanoma.~   "
266714|NCT00073879|"~     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use~     different ways to stop cancer cells from dividing so they stop growing or die. Peripheral~     stem cell transplantation may be able to replace immune cells that were destroyed by~     chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues.~     Alemtuzumab and tacrolimus may prevent this from happening.~      PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and~     cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem~     cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer).~   "
266715|NCT00073866|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Celecoxib may stop the growth of tumor cells by stopping blood flow~     to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan and~     docetaxel when given together with celecoxib and to see how well they work in treating~     patients with advanced non-small cell lung cancer.~   "
266716|NCT00073853|"~     Autologous Incubated Macrophages (ProCord) is being developed as a therapy for acute,~     complete spinal cord injury (SCI). The therapy is intended to reverse the loss of motor and~     sensory function.~      Following non-CNS tissue injury, macrophages quickly arrive on the scene, where they clean up~     cell debris, secrete different molecules thus promoting a controlled inflammatory reaction~     that forms the first phase of the wound healing process. While this process occurs in most~     tissues, including peripheral nerves, it does not occur in the CNS, where macrophages and~     other immune cells are relatively rare, and their activities curtailed by a biochemical~     mechanism known as immune privilege.~      In animal studies, it appears that incubated macrophages circumvent the immune privilege,~     thus supporting the regrowth of axons through the injury site and enabling the recovery of~     neurological function. The concept derives from the pioneering research of Prof. Michal~     Schwartz at the Weizmann Institute of Science.~   "
266717|NCT00073840|"~     The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2~     actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of~     bronchoconstriction in adolescent and adult subjects with asthma, with all treatments~     administered 4 times a day (QID).~   "
266718|NCT00073827|"~     The primary purpose of this study was to investigate the efficacy of levalbuterol compared to~     a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in~     adolescent and adult subjects with asthma, with all treatments administered 4 times a day~     (QID).~   "
266719|NCT00004857|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer~     cells and either kill them or deliver cancer-killing substances to them without harming~     normal cells.~      PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in~     treating patients who have chronic lymphocytic leukemia.~   "
266720|NCT00004261|"~     RATIONALE: EF5 may detect the presence of oxygen in tumor cells and help plan effective~     cancer treatment.~      PURPOSE: Phase I trial to study the effectiveness of EF5 in detecting the presence of oxygen~     in tumor cells of patients who are undergoing surgery or biopsy for breast, prostate, or~     cervical cancer or high grade soft tissue sarcoma.~   "
266721|NCT00004242|"~     Phase I trial to study the effectiveness of combination chemotherapy in treating patients who~     have metastatic or unresectable solid tumors. Drugs used in chemotherapy use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining more than one drug~     may kill more tumor cells.~   "
266722|NCT00003927|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~     Amifostine may protect normal cells from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, amifostine,~     and peripheral stem cell transplantation in treating patients who have stage II, stage III,~     or stage IV breast cancer.~   "
266723|NCT00073814|"~     Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects~     with Asthma~   "
266724|NCT00073788|"~     To evaluate Post-Traumatic Stress Disorder as a risk factor for cardiovascular disease in~     American Indians.~   "
266725|NCT00073775|"~     To examine the effects of psychological stress on the metabolic syndrome.~   "
266726|NCT00003811|"~     RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they~     stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from~     the side effects of chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and~     bleomycin plus amifostine in treating children who have malignant germ cell tumors.~   "
266727|NCT00003777|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more~     than one drug and combining radiation therapy and surgery with chemotherapy may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy,~     and combination chemotherapy in treating patients who have recurrent head and neck cancer~     that has been treated previously with radiation therapy.~   "
266728|NCT00003761|"~     This protocol is designed to evaluate the side effects of rV-DF3/MUC1 and to determine the~     safest dose which should be used in the treatment of breast cancer.~   "
266729|NCT00003729|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     children who have relapsed or refractory acute lymphocytic leukemia.~   "
266730|NCT00073801|"~     This study will examine pelvic pain associated with endometriosis and explore better~     approaches to treatment. In women with endometriosis, uterine tissue grows outside the~     uterus. Standard treatments - altering hormone levels to prevent endometrial tissue growth or~     surgically removing endometrial tissue - treat pelvic pain only temporarily. This study will~     investigate the role of sex hormones, immune chemicals, stress hormones, and genes in pelvic~     pain and determine how the nerve, muscle, and skeletal systems are involved in this pain.~      Women between 18 and 50 years of age who:~        1. have endometriosis and chronic pelvic pain, and~        2. have chronic pelvic pain without endometriosis, and~        3. have neither endometriosis nor chronic pelvic pain and are willing to have a tubal~          ligation (Healthy Volunteer group),~      may be eligible for this study. Candidates are screened with a questionnaire to obtain~     information about their pain and previous treatments and related medical or social issues.~     Participants will undergo the following tests and procedures:~        1. Medical history and physical examination, including pelvic exam, blood tests,~          urinalysis, and diaphragm fitting.~        2. Questionnaires about pain, quality of life, sexuality, psychological attitudes,~          spiritual experiences, and history of headache and depression.~        3. At-home monitoring for 4 to 6 weeks of pain symptoms, menstruation and spotting,~          medicines taken, and urine collections to test for LH surge. LH is the hormone that~          causes the ovary to release a mature egg.~        4. Pre-laparoscopy evaluation to include:~             -  Examination of menstrual blood collected in a diaphragm for 4 hours.~             -  Blood sampling to measure adrenal and pituitary hormones. For this test,~               corticotrophin-releasing hormone (CRH) is injected through an IV needle. Up to five~               blood samples are drawn, starting before the injection until 45 minutes after it.~               Blood is also collected at this time for genetic analysis.~             -  In-depth pain assessment to identify trigger points in muscles associated with~               pelvic pain, regions of skin sensitivity, and bone pain. Some women will undergo~               microdialysis, which uses an acupuncture-type needle to collect chemicals from two~               different muscles.~             -  Blood sampling twice a week for 1 month to measure changes in blood substances~               during the menstrual cycle.~             -  Blood sampling after the LH surge to measure progesterone levels.~             -  Cervicovaginal lavage (washing of the cervix with saline and collecting the fluid)~               to obtain secretions for research.~             -  Ultrasound of the ovaries and uterus. This examination uses a probe inserted into~               the vagina that emits sound waves that are used to form pictures of the internal~               structures. A small piece of uterine lining is also obtained for examination and~               research purposes.~             -  A visit with the members of the Pain and Palliative care service to evaluate the~               pain in anticipation of offering other treatments for pain after surgery.~             -  Surgery:~      CPP + Endo or CPP only: Laparoscopy to look for and remove endometrial tissue. This procedure~     is done under general anesthetic. A viewing instrument called a laparoscope is passed through~     an incision in the belly button to look for endometriosis. If it is found, two or more~     incisions are made in the abdomen for other instruments to remove the tissue. A small piece~     of uterine lining is also obtained for examination and research purposes.~      Healthy Volunteers: Laparoscopy to perform the tubal ligation. A tubal ligation, commonly~     known as getting your tubes tied, is a surgical procedure for women to sterilize them. This~     procedure closes the fallopian tubes, stopping the egg from traveling from the ovary to the~     uterus and preventing sperm from reaching the fallopian tube to fertilize an egg. In a tubal~     ligation, fallopian tubes are cut, burned, or blocked with rings, bands or clips. The surgery~     is effective immediately. Tubal ligations are 99.5% effective as birth control. This~     procedure is done under general anesthetic. A viewing instrument called a laparoscope is~     passed through an incision in the belly button to perform a tubal ligation. Two or more~     incisions are made in the abdomen for other instruments to perform the procedure. During the~     laparoscopy, we will look for and remove endometrial tissue. A small piece of uterine lining~     is also obtained for examination and research purposes.~      -Follow-up evaluations. Two weeks after surgery, patients return to NIH to discuss the~     surgical findings and treatment options. Follow-up visits are then scheduled at 1, 3, and 6~     months after surgery to complete questionnaires and determine if the treatment is working.~     Blood samples are drawn at each visit.~   "
266731|NCT00003734|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using~     triptorelin and flutamide may fight cancer by reducing the production of androgens. It is not~     yet known whether giving hormone therapy for 4 months is more effective than giving therapy~     for 8 months prior to radiation therapy for prostate cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy~     for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer.~   "
266732|NCT00073762|"~     Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving~     DVS-233 SR versus subjects receiving placebo.~      Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical~     global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton~     Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus~     those subjects receiving placebo.~   "
266733|NCT00073749|"~     To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety~     profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).~   "
266734|NCT00073736|"~     Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is~     being developed for the treatment of inoperable HCC, using a platform technology known as~     HepDirectTM, which enables drugs to be targeted specifically to the liver. The objective for~     this study is to determine the safety and tolerability of MB07133.~   "
266735|NCT00073723|"~     The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has~     a broad spectrum of activity against several human cancers including carcinomas of ovary,~     breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against~     metastatic breast cancer, yielding response rates in the range of 40% to 60% in~     chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing~     regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability~     requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle~     must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a~     premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.~   "
266736|NCT00003716|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have~     lymphoproliferative disorder that is associated with immunosuppression therapy.~   "
266737|NCT00003694|"~     Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in~     treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia. Drugs~     used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Combining more than one drug may kill more cancer cells.~   "
266738|NCT00003679|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether doxorubicin plus docetaxel is more effective than doxorubicin plus~     cyclophosphamide for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of doxorubicin in~     combination with either docetaxel or cyclophosphamide in treating women who have previously~     untreated, advanced, or inflammatory breast cancer.~   "
266739|NCT00003598|"~     RATIONALE: Tretinoin may help cervical neoplasia cells develop into normal cervical cells. It~     is not yet known whether tretinoin is more effective than a placebo in preventing cervical~     cancer in patients with cervical neoplasia.~      PURPOSE: Randomized clinical trial to study the effectiveness of tretinoin in preventing~     cervical neoplasia from developing into cervical cancer.~   "
266740|NCT00003450|"~     RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability~     to fight cancer or make the cancer more sensitive to chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of gene therapy using the p53 gene in~     treating patients with advanced recurrent or persistent ovarian cancer or primary peritoneal~     cavity cancer.~   "
266741|NCT00073710|"~     A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption~     in hemodialysis subjects.~   "
266742|NCT00073697|"~     This study will determine how certain features of depressed individuals affect their~     responses to depression treatment.~   "
266743|NCT00073684|"~     This study will determine the necessity of including abuse-focused interventions in the~     treatment of sexually abused children.~   "
266744|NCT00073671|"~     This study examines the impact of a group cognitive behavioral program aimed at preventing~     depressive disorders and symptoms in adolescents at risk for developing depression.~   "
266745|NCT00073658|"~     This study will compare the safety and effectiveness two medications, citalopram (Celexa®)~     and risperidone (Risperdal®).~   "
266746|NCT00073645|"~     This study will compare the effectiveness of family- and peer-oriented therapy in treating~     children with anxiety disorders and will also test for therapy specificity effects and~     potential mediators of outcome.~   "
266747|NCT00073632|"~     This study will develop and implement an awareness- and acceptance-based for treatment of~     individuals with generalized anxiety disorder.~   "
266748|NCT00073619|"~     This study will determine the effectiveness of a cognitive-behavioral group therapy program~     in preventing anxiety disorders in at-risk children exposed to community violence.~   "
266749|NCT00073606|"~     This study will examine the role of the spinal cord in improving leg movements after physical~     training in healthy people. The results of this study may be helpful in developing new~     rehabilitation therapies for people with impaired leg function.~      Healthy volunteers between 21 and 65 years of age may be eligible for this study. Candidates~     will be screened with a brief medical history and physical examination.~      Participants will undergo EMG-H reflex measurement while pedaling on a stationary bicycle.~     For this test, the subject is given an electrical stimulation at the nerve at the back of the~     knee while pedaling on a stationary bicycle. The shock produces a jerky movement called the~     H reflex. The muscular activity causing these reflexes is measured using electrodes (small~     metal disks) filled with a conductive gel and taped to the skin over the calf muscle. The~     nerve is stimulated at four different frequencies during the experiment. While cycling, pedal~     resistance changes, making it harder or easier to pedal.~      On study day 1, participants have EMG-H reflex measurement to determine baseline performance,~     then a training session to prepare for the actual test, and then a post-training test to~     measure performance again. The test is repeated on days 2, then between days 5 and 8, and~     again between days 11 and 14. The screening and first visit last 2 hours; the remaining test~     visits are 1 hour each. The bicycling time is only 15 minutes during training and 5 minutes~     at each test session.~   "
266750|NCT00003426|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of gemcitabine plus radiation therapy in~     treating patients with pancreatic cancer that can not be surgically removed.~   "
266751|NCT00003414|"~     RATIONALE: Cyclosporine may induce graft-versus-host disease and make the body build an~     immune response that will kill cancer cells. Interleukin-2 and interferon gamma may enhance~     the effectiveness of graft-versus-host disease to kill cancer cells.~      PURPOSE: Randomized phase III trial to determine the effectiveness of graft-versus-host~     disease in treating patients who have recurrent or refractory lymphoma or Hodgkin's disease .~   "
266752|NCT00003409|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin~     gadolinium may increase the effectiveness of radiation therapy by making tumor cells more~     sensitive to radiation.~      PURPOSE: Phase I trial to study the effectiveness of motexafin gadolinium plus radiation~     therapy in treating patients who have newly diagnosed glioblastoma multiforme.~   "
266753|NCT00003388|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients~     with AIDS-related lymphoma.~   "
266754|NCT00073593|"~     The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative~     anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary~     artery bypass graft surgery.~   "
266755|NCT00073580|"~     The purpose of this study is to examine the safety and efficacy of Angiomax as an~     anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced~     thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass~     (OPCAB) surgery.~   "
266757|NCT00073541|"~     EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000~     blocks a factor found on the surface of many cancer cells. The factor is called epidermal~     growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian~     cancer. This study will test the safety and effects of EMD 72000 in subjects with~     EGFR-positive recurrent ovarian cancer following standard treatment that has failed.~   "
266758|NCT00073528|"~     This study will compare the efficacy and tolerability of GW572016 administered in combination~     with letrozole, versus letrozole and placebo, as treatment for hormone receptor-positive~     advanced or metastatic breast cancer.~   "
266759|NCT00003387|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not yet known whether giving chemotherapy before combined chemotherapy and radiation~     therapy is more effective than combined chemotherapy and radiation therapy alone in treating~     patients with non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and~     paclitaxel followed by radiation therapy and chemotherapy with radiation therapy and~     chemotherapy alone in treating patients with stage III non-small cell lung cancer that cannot~     be removed during surgery.~   "
266760|NCT00003313|"~     RATIONALE: Amifostine may be an effective treatment for the toxic side effects caused by~     radiation therapy and chemotherapy. It is not yet known whether chemotherapy and radiation~     therapy are more effective with or without amifostine for non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of amifostine in treating~     patients who have stage II or stage III non-small cell lung cancer that cannot be surgically~     removed and who are undergoing chemotherapy and radiation therapy.~   "
266761|NCT00003253|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Some patients may develop a resistance to chemotherapy drugs.~      PURPOSE: Phase II trial to determine the reliability of a test for measuring drug resistance~     to paclitaxel in patients with metastatic breast cancer.~   "
266762|NCT00003202|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to compare the effectiveness of gemcitabine with radiation therapy~     alone or following two-drug combination chemotherapy in treating patients with stage III~     non-small cell lung cancer.~   "
266763|NCT00003191|"~     Phase I trial to study the effectiveness of fenretinide in treating children who have solid~     tumors that have not responded to standard therapy. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die.~   "
266764|NCT00073515|"~     This trial is for patients with a central venous catheter (a vascular access device) that is~     not functioning properly (unable to withdraw blood). The trial compares a new blood clot~     dissolving agent (alfimeprase) against the currently used treatment.~   "
266765|NCT00073502|"~     Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety~     of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit~     after two cycles may be switched to a commonly used combination regimen.~   "
266766|NCT00073489|"~     The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL~     patients.~   "
266767|NCT00073463|"~     The purpose of this study is to confirm the improvement in pulmonary function and cytokine~     levels observed in the recently completed multidose aerosol study for the treatment of Cystic~     Fibrosis (CF).~   "
266768|NCT00003167|"~     Phase I trial to study the effectiveness of gene therapy in treating patients with advanced~     bladder cancer. Inserting the p53 gene into a person's bladder cancer cells may improve the~     body's ability to fight cancer~   "
266769|NCT00003130|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women who have~     recurrent solid tumors.~   "
266770|NCT00003060|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow~     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Clinical trial to study the effectiveness of chemotherapy plus bone marrow~     transplantation in treating patients with metastatic melanoma that has not responded to~     previous therapy.~   "
266771|NCT00003037|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy with~     docetaxel, gemcitabine, and cisplatin as induction therapy in treating patients with stage~     III non-small cell lung cancer.~   "
266772|NCT00002989|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of idarubicin plus~     peripheral stem cell transplantation using the patient's own or donated stem cells in~     treating patients with leukemia or myelodysplastic syndrome.~   "
266773|NCT00073476|"~     The purpose of this study is to determine whether a new research medication is effective and~     safe for the treatment of acute stroke when given within 6 hours of the onset of stroke.~   "
266774|NCT00073450|"~     The purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein~     Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous~     Cell Carcinoma of the Head & Neck and will help determine if further development is~     justified.~   "
266775|NCT00073437|"~     The purpose of this study is to evaluate the safety and effectiveness of infliximab~     (Remicade) in patients with Chronic Sarcoidosis. Infliximab (Remicade) targets specific~     proteins in the body's immune system to help control the development of inflammation to help~     reduce painful disease.~   "
270703|NCT00045864|"~     The purpose of this study is to determine the safety and effectiveness of combination therapy~     with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's~     lymphoma.~   "
266776|NCT00002940|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients with~     Epstein-Barr virus-associated primary CNS lymphoma and AIDS.~   "
266777|NCT00002836|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy. Peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus~     filgrastim with filgrastim alone in treating women undergoing peripheral stem cell~     transplantation for stage II, stage III, or metastatic breast cancer.~   "
266778|NCT00002828|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of raltitrexed and fluorouracil in treating~     patients who have colorectal cancer that is metastatic, recurrent, or cannot be surgically~     removed.~   "
266779|NCT00002812|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug and giving the drugs in different~     combinations may kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination~     chemotherapy treatment with more intensive combination chemotherapy in treating children with~     acute lymphocytic leukemia.~   "
266780|NCT00002761|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.~   "
266781|NCT00073424|"~     Taking anti-HIV medication consistently and properly is a critical issue for patients with~     HIV. Drug regimens are complex; when regimens are not taken properly, HIV can become~     resistant to the drugs. Taking anti-HIV medication properly leads to improved health.~     Children and adolescents with HIV face unique challenges to taking HIV medication properly.~     This study will look at the relationship between how children cope with the responsibility~     for taking medication and the child's language, memory, attention, behavior, and academic~     skills. This study is open to children and adolescents who are currently enrolled in the~     PACTG 219C study (Long-Term Effects of HIV Exposure and Infection in Children).~   "
266782|NCT00073411|"~     The purposes of this study are to determine:~        -  The safety of duloxetine and any side effects that might be associated with it.~        -  How duloxetine compares to escitalopram and placebo (an inactive ingredient)~   "
266783|NCT00073385|"~     This randomized study will assess the efficacy and safety of the combination of Pivanex and~     docetaxel compared to docetaxel alone in patients with a type of lung cancer called non-small~     cell lung cancer. Pivanex is an investigational agent, and docetaxel is an approved drug.~   "
266784|NCT00073372|"~     The purpose of this study is to determine the effectiveness of abciximab in the treatment of~     acute ischemic stroke.~   "
266785|NCT00073359|"~     The purpose of this study is to identify and evaluate therapist behaviors that affect how~     well and how long adolescent patients stay in treatment for depression.~   "
266786|NCT00073346|"~     This study will develop and test a cognitive behavioral treatment for compulsive accumulation~     of goods.~   "
266787|NCT00073333|"~     This study will determine whether people with social phobia are deficient in certain social~     skills.~   "
266788|NCT00073320|"~     The purpose of the study is to compare the pharmacokinetic parameters (blood concentrations)~     of i.m. paliperidone palmitate after administration in 2 different injection sites (deltoid~     or gluteal).~   "
266789|NCT00073307|"~     The purpose of this study is to evaluate safety, efficacy (including quality of life), and~     pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with~     unresectable and/or metastatic renal cell cancer, who have received one prior systemic~     regimen for advanced disease.~   "
266790|NCT00036920|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of TLK286 in treating patients who have~     advanced non-small cell lung cancer.~   "
266791|NCT00027521|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy~     drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more~     tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of electroporation therapy and bleomycin in~     treating patients who have locally advanced pancreatic cancer.~   "
266792|NCT00025532|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver~     tumor-killing substances to them without harming normal cells. This may be an effective~     treatment for gastrointestinal cancer.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy~     in treating patients who have gastrointestinal cancer.~   "
266793|NCT00002561|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells.~     Combining more than one drug or combining chemotherapy with radiation therapy may kill more~     tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with~     or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage~     IIA Hodgkin's disease.~   "
266806|NCT00073151|"~     The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how~     long the tumor shrinkage can be maintained in patients with non-small cell lung cancer.~     Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7~     days before starting the next cycle of drug.~   "
270704|NCT00045838|"~     This study will test the safety of an experimental vaccine against HIV and examine whether it~     induces an immune response to HIV. A vaccine is a substance given to try to create resistance~     or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic~     material) of four HIV proteins called gag, pol, Nef, and Env. Injected into a human, the~     viral DNA instructs the body to make small amounts of some HIV proteins. This study will see~     if the body then creates an immune response to these proteins. Study participants cannot~     catch HIV or AIDS from the DNA vaccine or any proteins made from it.~      Healthy normal volunteers between 18 and 60 years of age may be eligible for this study.~     Candidates will provide a medical history, including information on sexual behaviors and drug~     use. They will have a physical examination and blood and urine tests. Women will also have a~     pregnancy test. Women enrolled in the study must either be infertile (e.g., due to menopause~     or hysterectomy) or must agree either to abstain from heterosexual sex or to practice birth~     control for at least 21 days before beginning the study and throughout its duration.~      Participants will be randomly assigned to receive either the experimental vaccine or a~     placebo (a control substance made up of an inactive salt solution) and will be divided into~     three groups, based on their entry into the study. Of the first seven people enrolled (Group~     1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is~     safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two~     will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an~     8-mg dose of vaccine and six will receive placebo.~      All participants will receive three injections in an upper arm muscle-one injection a month~     for three months-with a needle-less device called a Biojector 2000® (Registered Trademark).~     At the time of each injection, participants will be observed for at least 1 hour after~     immunization. At home, they will record their temperature and any symptoms they may~     experience, including any effects at the injection site, for at least 2 days, or as long as~     the symptoms remain. If symptoms occur, participants will report them immediately to the~     clinic staff and, if necessary, come to the clinic for an examination.~      Participants will have about 10 clinic visits during the study. Most visits will last about 2~     hours; those on vaccination days will last about 4 hours. At each visit, participants will be~     checked for health changes or problems and will be asked about medications they are taking.~     Blood will be drawn for immune system testing. Additional laboratory tests may be requested~     between visits. Participants will be tested several times for HIV, will be questioned about~     their sexual behavior and drug use, and about social effects they may have experienced from~     their participation in the study.~      Some of the blood drawn for this study will be used to test for HLA type-a genetic test of~     immune system markers. For research, HLA testing is sometimes used to try to identify factors~     associated with the progression of HIV disease or related conditions.~   "
266794|NCT00073398|"~     This 2-phase study will determine the safety of treating patients with non-small cell lung~     cancer with the genetically engineered HyperAcute-Lung cancer vaccine. It will establish the~     proper vaccine dose and will examine side effects and potential benefits of the treatment.~     The vaccine contains killed lung cancer cells containing a mouse gene that causes the~     production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the~     immune response to the foreign substance will stimulate the immune system to attack the~     patient's own cancer cells that have similar proteins without this sugar pattern, causing the~     tumor to remain stable or shrink.~      Patients 18 years of age or older with non-small cell lung cancer that has recurred or no~     longer responds to standard treatment may be eligible for this study. Candidates will be~     screened with a medical history and physical examination, blood tests, urinalysis, chest~     x-rays, and lung function testing. CT, MRI, PET, and ultrasound scans of the chest may be~     obtained if needed.~      Participants will receive four vaccinations a month apart from each other. The vaccines will~     be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of~     the study will treat successive groups of patients with increasing numbers of the vaccine~     cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will~     look for any beneficial effects of the vaccine given at the highest dose found to be safe in~     Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In~     addition, patient follow-up visits will be scheduled every 2 months for the first year after~     vaccination and then every 3 months for the next 2 years for the following tests and~     procedures to evaluate treatment response and side effects:~        -  Medical history and physical examination~        -  Blood tests~        -  X-rays and various scans (nuclear medicine/CT/MRI)~        -  FACT-L Assessment questionnaire to measure the impact of treatment on the patient's~          general well-being. The questionnaire is administered before beginning treatment, before~          each vaccination, and during follow-up visits after completing the treatment. It~          includes questions on the severity of lung cancer symptoms and the ability to perform~          normal activities of daily life.~      In addition to the above procedures, 3 skin punch biopsies will be done at the vaccination~     site to look for a local immune response. For this procedure, an area of skin is numbed with~     an anesthetic and a 4 mm (about 1/4-inch) circular area is removed, using a sharp cookie~     cutter-type instrument. Also, one blood sample per year will be collected for the next 15~     years to monitor the safety of the gene transfer. Patients whose lung cancer spreads to the~     skin, superficial soft tissues, or a superficial lymph node may be asked to undergo a biopsy~     of the lesion to see what effect the treatment may be having on the tumor.~   "
266795|NCT00073294|"~     This is a pilot study to examine the prevalence of metabolic risk factors (impaired insulin~     release and impaired insulin sensitivity) for type 2 diabetes mellitus in children and adults~     from a population that is at high risk for this disease. We hypothesize that at least one of~     these pre-diabetic traits will be evident in a large proportion of relatives of known type 2~     diabetic children as compared to a control group of subjects without a family history of type~     2 diabetes. By isolating these traits, it will be possible to determine the relative~     contributions of genes and environment to each trait and to identify those at risk for~     subsequent development of type 2 diabetes by virtue of having one trait. Ultimately, those~     individuals at risk, especially those with impaired insulin release, would hopefully benefit~     from intervention to prevent the weight gain that will 'unmask' their underlying pancreatic~     dysfunction and thus prevent or retard the development of type 2 diabetes.~   "
266796|NCT00073281|"~     This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with~     stable renal allografts by islet transplantation.~   "
266797|NCT00073255|"~     To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen~     administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).~   "
266798|NCT00073268|"~     This is a pilot study to examine the short-term effects of supervised exercise on metabolic~     risk factors for type 2 diabetes mellitus in children from a population that is at high risk~     for this disease. We hypothesize that exercise will significantly improve insulin sensitivity~     in all children, especially in children who are already insulin resistant, thereby lowering~     the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses~     being tested are:~        1. Insulin resistance will be most evident in overweight children while an impaired ability~          of the pancreas to release insulin will be most evident in children with a family~          history of type 2 diabetes mellitus.~        2. Exercise will significantly improve insulin resistance (as measured by the fasting~          glucose/insulin ratio) with little or no effect on insulin secretory capacity (as~          measured by circulating insulin concentration at 1, 3, and 5 minutes following an~          intravenous glucose load) in children.~        3. Participation in a school-based health, nutrition, and exercise education program will~          have long-term beneficial effects on health-related behaviors and on insulin resistance.~   "
266799|NCT00073242|"~     Our previous studies have demonstrated that there is substantial metabolic opposition to the~     maintenance of an altered body weight. Leptin is a protein secreted by fat cells and the~     circulating concentrations of leptin are directly proportional to fat mass. Leptin-deficiency~     is associated with severe obesity in rodents and in humans and the obesity is relieved by~     leptin administration. These studies examine the hypothesis that some of this metabolic~     opposition cto the maintenance of an altered body weight can be relieved by restoring~     circulating concentrations of the hormone leptin to the same range as at usual body weight in~     subjects who are maintaining a reduced body weight. The basic design of this study is to~     observe subjects at a 10% reduced body weight and then again at that reduced body weight~     while receiving physiological leptin or T3 supplementation.~   "
266800|NCT00073229|"~     This observational study will evaluate data from infants born to HIV infected mothers in~     order to better characterize disease progression in early HIV infection.~   "
266801|NCT00073216|"~     To prevent HIV infection, a vaccine that produces strong HIV-specific humoral (B-cell) and~     cellular (T-cell) immune system responses is desirable. The purpose of this study is to test~     the safety of and immune response to a novel combination HIV vaccine in HIV uninfected~     adults. This study will also test the safety of and immune response to a protein vaccine~     given alone.~   "
266802|NCT00073203|"~     The purpose of this research study is to determine the effectiveness of 2 target doses of~     R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely~     depressed adult subjects with major depressive disorder.~      Approximately 488 subjects will be involved in the study.~   "
266803|NCT00073177|"~     The aim of the study is to compare the effects of oral roflumilast with placebo on lung~     function in patients with asthma.~   "
266804|NCT00073190|"~     Osteoporosis is an important public health problem. Osteoporosis can cause serious health~     complications and death and leads to increased medical costs. The purpose of this study is to~     identify an effective method of educating patients and health care professionals about the~     diagnosis and treatment of osteoporosis.~   "
266805|NCT00073164|"~     The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote~     ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy~     with olanzapine or risperidone for the treatment of schizophrenia.~   "
267650|NCT00036660|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have~     recurrent malignant glioma.~   "
266807|NCT00073138|"~     The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how~     long the tumor shrinkage can be maintained in patients with colorectal cancer. Patients will~     receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before~     starting the next cycle of drug.~   "
266808|NCT00073125|"~     The primary objective of this study is to assess the safety and efficacy of ABT-510 in~     subjects with advanced renal cell carcinoma.~   "
266809|NCT00073112|"~     The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how~     long the tumor shrinkage can be maintained in patients with renal cell cancer. Patients will~     receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before~     starting the next cycle of drug.~   "
266810|NCT00073047|"~     The purpose of The PROSPECT Study is to evaluate an investigational medication for the~     treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38~     clinical research centers in the US, Canada, and Belgium, and is open to male and female~     patients 12 years and older. Participants in the study will have a number of visits to a~     research center over a five-month period. All study related care and medication is provided~     to qualified participants at no cost: this includes all visits, examinations, and laboratory~     work.~   "
266811|NCT00073034|"~     EAA-090 is being developed for the treatment of neuropathic pain associated with diabetic~     neuropathy. It is a selective antagonist that binds competitively to the glutamate site of~     the N-methyl-D-aspartate (NMDA) receptor.~      This study will assess the safety and efficacy of 3 fixed oral doses of EAA-090 compared with~     placebo in subjects with neuropathic pain associated with diabetic neuropathy.~   "
266812|NCT00073099|"~     Surface eye problems (problems of the cornea and conjunctiva), such as dry eye, are often~     evaluated using ocular surface staining - the application of a colored dye to the surface of~     the eye. The physician examines the nature, degree, and pattern of staining on the eye's~     surface to determine the diagnosis, assess disease severity, and document treatment effects.~     Grading of ocular surface staining is often used in research studies to measure the response~     to a treatment or treatment side effects. Therefore, it is critical that the grading~     methodology be reproducible and sufficiently detailed to detect changes in eye health status.~     Current evaluation techniques using these dyes are somewhat subjective, however, since they~     require human assessment and judgment. This study will assess the validity and reliability of~     digital photography and compare it with standard slit lamp evaluation for analyzing ocular~     surface dye staining to document surface eye damage in patients with dry eye.~      Patients 3 years of age and older with dry eye may be eligible for this study. Participants~     will have the following tests and procedures:~        -  Visual acuity: (eye chart) test~        -  Slit lamp evaluation: Examination of the front part of the eye with a special microscope~          called a slit lamp biomicroscope. Special dyes derived from vegetables are instilled~          into the eye to stain the surface of the eye where it is dry and damaged. The doctor~          then determines the extent of staining. The staining will be repeated within one week of~          the first examination.~        -  Digital eye photography: Digital photographs of the eye are taken to aid in assessing~          the extent of dry eye changes. The camera flashes a bright light for each picture. About~          5 to 10 pictures are taken for each eye.~   "
266813|NCT00073086|"~     This study will evaluate and treat people with SARS, a new type of pneumonia (lung infection)~     originating in China. SARS is caused by a new virus that is easily transmitted from person to~     person. This study will look at the course of the disease; determine how the virus affects~     the body and how the body fights the infection; and evaluate diagnostic tests to quickly~     identify the disease.~      People 18 years of age and older with probable or suspected SARS may be eligible for this~     study. Close contacts of patients with SARS, patients who recovered from SARS, and NIH health~     care workers involved in the care of patients will also be enrolled. Patients with SARS who~     require hospitalization will be admitted to the NIH Clinical Center. Because SARS spreads~     easily, hospitalized patients will be in a room by themselves and will not be allowed any~     visitors. They will not leave their room except for tests, such as x-rays.~      All participants will have a full medical examination, including a medical history, physical~     examination, and blood tests. In addition, the participants undergo various tests and~     procedures as follows:~        -  Probable and suspected SARS patients may be hospitalized or may be seen as outpatients.~          They are provided the treatment judged best for their disease, usually according to~          expressed or published recommendations. The best treatment for SARS is not yet known,~          and there have been no studies evaluating therapies. Outpatients are seen three times a~          week for 2 weeks, once a week for 4 more weeks, and then at 6 months. Patients have~          mouth and throat swabs taken three times a week for the first 2 weeks, then once a week~          for 4 more weeks. Blood is drawn three times a week for the first 2 weeks, then once at~          weeks 3, 4, and 6. If virus is still detectable after 6 weeks, nose washings and throat~          swabs are repeated until no virus is detected for 3 weeks in a row. In addition,~          patients provide urine and stool samples, have a chest x-ray and electrocardiogram, and~          undergo bronchoscopy and bronchial lavage. For the bronchoscopy, a bronchoscope~          (pencil-thin flexible tube) is passed into the large airways of the lung, allowing the~          physician to examine the airways. Cells and secretions from the airways are rinsed from~          the lung with salt water. A brush the size of a pencil tip is passed through the~          bronchoscope to scrape cells lining the airways and pieces of tissue are collected for~          analysis.~        -  Close contacts of patients are evaluated twice a week for 2 weeks, then once a week for~          2 more weeks. Blood is drawn at the first visit and then at 1, 2, and 4 weeks. Mouth and~          throat swabs, nose washings, and sputum collections are done twice a week for 2 weeks,~          then once a week for 2 more weeks. Urine and stool samples are collected once a week for~          4 weeks. If virus from the nose or throat is still detectable after 4 weeks, weekly nose~          washings and throat swabs continue until no virus is detected for 3 weeks in a row.~          Blood may also be drawn during the weekly visits.~        -  Recovered SARS patients provide blood, urine, and stool samples and have a mouth and~          throat swab and nose aspiration to see if the SARS virus is present. For the nasal~          aspiration, salt water is put in the nose and then suctioned out. Usually, these tests~          are done only once. If virus is detected, however, the nose washing, throat swabs and~          blood tests are repeated once a week until no virus is detected for 3 weeks in a row.~        -  Health care workers document their contact with patients, use of isolation procedures~          and equipment, and any unexpected events that occur during contact. They are evaluated~          for symptoms of infection and provide a blood sample once a month~   "
266814|NCT00073073|"~     The primary goal of this 5-year study is to determine whether exemestane alone or in~     combination with celecoxib decreases breast tissue density in healthy postmenopausal women at~     high risk for breast cancer. Dense breast tissue seen on mammography has been linked to an~     increased risk of breast cancer. The study will also examine the effects of exemestane and~     celecoxib on bone density, blood hormone levels and quality of life. Exemestane, approved by~     the Food and Drug Administration for treating postmenopausal women with breast cancer, lowers~     the amount of estrogen in the body. Celecoxib, approved for treating arthritis pain and for~     reducing the number or colon polyps in an inherited syndrome, is an anti-inflammatory drug.~     Half of the women in the study will receive exemestane alone and half will receive exemestane~     and celecoxib together.~      In December 2004, the arm using exemestane and celecoxib was closed to accrual~      Postmenopausal women who are at increased risk for developing invasive breast cancer may be~     eligible to participate. Candidates are screened with breast cancer risk assessment, medical~     history and physical examination, blood tests, review of medical records, if needed, breast~     biopsy, and dual energy x-ray absorptiometry (DEXA) scan to assess bone density. For the DEXA~     scan, the subject lies still on a table for about 30 minutes while the spine and hip are~     scanned using a small amount of radiation.~      Participants take exemestane in pill form once a day for 2 years. They also take calcium and~     vitamin D pills daily to help protect bone health. They are followed in the clinic during the~     course of the study to determine the amount of drug taken and any side effects, and for the~     following tests and procedures:~        -  Medical evaluation and blood tests at after 1 and 3 months on study drugs~        -  Medical evaluation at 6 months~        -  Breast biopsy at screening and then at 12 months~        -  dual-emission x-ray absorptiometry (DEXA) scan of the spine, mammogram and routine blood~          tests before starting study drugs and then yearly for 5 years.~   "
266815|NCT00073060|"~     This study will examine the effects of repeated apheresis procedures on bone density and~     calcium balance. Apheresis is a procedure for collecting large numbers of a specific blood~     component, such as white cells (leukapheresis) or platelets (plateletpheresis). For the~     procedure, whole blood is collected through a needle in an arm vein and is directed through a~     machine that separates it into its components by spinning. The desired cells are removed and~     the rest of the blood is returned to the donor, either through the same needle or through a~     needle in the other arm. A blood thinning medicine called citrate is added to the~     cell-separating machine. Citrate reduces the ionized calcium levels in the blood, which~     prevents the blood from clotting. When the blood is returned to the donor, the donor also~     receives the citrate. This lowers the donor's ionized calcium levels which may irritate nerve~     and muscle cells, causing tingling around the mouth, hands, and feet during the procedure.~     The reduced ionized calcium levels result in increased parathyroid hormone levels in the~     donor, can effect bone calcium stores. In addition, some of the citrate that is returned to~     the donor is excreted in the urine along with calcium, which causes further loss of calcium~     from the body. It is not known if the calcium loss during apheresis in people who undergo~     this procedure repeatedly has any long-term effects on body calcium balance and bone calcium~     stores. This study will measure bone density and calcium balance in long-term platelet and~     white cell donors and compare the findings with those of whole blood donors, who do not~     receive citrate.~      Healthy people between 18 and 80 years of age who weigh between 110 and 300 pounds, do not~     have a metal prosthesis, and are not pregnant may be eligible for this study. Participants~     undergo the following procedures:~      Whole blood donors~        -  Blood sample collection 2 weeks before blood donation.~        -  I removed undergo standard whole blood donation~        -  Urine sample collection.~        -  DEXA scan to assess bone density by measuring bone calcium stores. For this procedure,~          the subject lies still on a table while the spine, hip, and whole body are scanned using~          a small amount of radiation. The forearm is also scanned while the subject is seated.~          The scan may be repeated after 2 years.~      Plateletpheresis and leukapheresis donors~        -  Standard platelet or white cell donation.~        -  Blood sample collections immediately prior to and after donation, and on the first,~          fourth, and fourteenth days after donation.~        -  Urine sample collections at the beginning and at the end of the apheresis procedure and~          on the first, fourth, and fourteenth days after the donation.~        -  DEXA scan at the beginning of the study (no earlier than 2 weeks after their latest~          apheresis donation). The scan may be repeated after 2 years.~        -  Some apheresis donors may be asked to have a second procedure in which they take calcium~          according to standard guidelines for plateletpheresis and leukapheresis. During the~          second procedure, platelet donors will take oral calcium tablets before starting~          plateletpheresis. White cell donors will receive calcium intravenously (through a vein)~          during the second leukapheresis. For this second procedure, the donors provide~          additional blood and urine samples as described above.~   "
266816|NCT00073021|"~     This study is a prospective clinical study to evaluate the safety and efficacy of two~     different doses of Asacol for the treatment of moderately active ulcerative colitis. In~     addition, a new tablet formulation will be evaluated at one of the two doses.~   "
266817|NCT00073008|"~     This study was designed to evaluate and compare the efficacy of two dose schedules of an oral~     investigational drug for the treatment of advanced or metastatic non-small cell lung cancer.~   "
266818|NCT00072995|"~     The purpose of this study is to test the effectiveness for weight loss and weight maintenance~     of four diets differing in macronutrient composition: moderate in fat (40 percent energy)~     with two different protein levels (15 percent and 25 percent), and low in fat (20 percent~     energy), also with 15 percent and 25 percent protein levels. The study is only accepting~     participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further~     enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design~     Narrative.~   "
266819|NCT00072982|"~     The object of this study is to determine whether treatment of rheumatoid arthritis (RA) with~     a combination of fish oil and borage seed oil is superior to treatment with either oil alone.~     This study will also investigate the biochemical, immunological, and molecular mechanism~     responsible for the therapeutic effects of these fatty acids. Each patient will be followed~     for eighteen months.~   "
266820|NCT00072943|"~     The purpose of the HARMONY study is to assess the safety and efficacy of an investigational~     drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a~     humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks~     IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are~     proteins normally produced by our immune system to help fight off foreign substances.~     Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the~     antibodies in our bodies, to target diseases.~   "
266821|NCT00072930|"~     The primary objectives of this study are:~        1. To explore the antitumor activity of MEDI-522 in combination with docetaxel, prednisone,~          and zoledronic acid in patients with metastatic Androgen-Independent Prostate Cancer~          (AIPC); and~        2. To summarize the safety of MEDI-522 in combination with docetaxel, prednisone, and~          zoledronic acid in this patient population.~   "
266822|NCT00072917|"~     This is a longitudinal cohort study of how the responses to a 3 day period of controlled~     overfeeding relate to subsequent weight gain. We hypothesize that thin individuals are~     resistant to weight gain because they respond to periods of overfeeding by increasing fat~     oxidation, reducing food intake, and increasing physical activity relative to those who gain~     weight over time.~   "
266823|NCT00072904|"~     To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting~     hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing~     the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize~     pulmonary function in cystic fibrosis (CF).~   "
266824|NCT00072891|"~     This study is designed to study how adults with Type 2 Diabetes and either high blood~     pressure and/or high blood cholesterol manage their treatment regimen. It is also called the~     Diabetes Management Study. Individuals need to be 40 years of age or older and on oral~     medication (pills) management for two of the three conditions of interest. They may also be~     on other treatment such as insulin, diet and/or exercise programs. Individuals will be~     followed for approximately 12 months. About 1/4 of the persons in the study will receive a~     telephone counseling program with a nurse focused upon their management of their treatment~     program.~   "
266825|NCT00072969|"~     This study will evaluate a new immunosupressive therapy, Daclizumab, and compare it with~     antithymocyte globulin (ATG) to treat cytopenia, that is, the deficiency of cellular elements~     of the blood, in myelodysplastic syndrome (MDS). Daclizumab is an anti-interleukin-2 receptor~     (IL-2) antibody. MDS, also known as myelodysplasia, is a disorder that can cause anemia,~     spontaneous bleeding, and greater risk of infections. Although the bone marrow can still~     produce some blood cells, very few reach the bloodstream. The cause of MDS is not known,~     although its behavior is. Many patients need transfusions of red blood cells. They may also~     develop leukemia, which is often quite resistant to treatment with chemotherapy. However, the~     progression of the disorder to leukemia is usually slow, taking many years.~      Patients 18 years of age and older who have MDS may be eligible for this study. Participants~     will undergo the following tests and procedures:~        -  Medical history and physical examination.~        -  Collection of blood for tests including blood counts, liver and kidney function, and~          antibodies against common viruses.~        -  Chest x-ray.~        -  Electrocardiogram.~        -  Bone marrow sample to confirm the diagnosis.~      Participants will randomly receive either ATG or Daclizumab. If they are in the group to~     receive ATG, they will be admitted as inpatients to undergo the first 10 to 14 days of~     treatment. If they do not already have a catheter in one of the large veins of the neck,~     chest, or arm, one will be placed. ATG will be given through the catheter. Blood counts and~     other blood analysis will be monitored daily while the patients are treated. After about 10~     days, they will be released, to be under the care of their referring physicians. Those~     participants who are in the group to receive Daclizumab will receive a total of five doses,~     one every 2 weeks, over 8 weeks, given through a vein as a 15-minute infusion. The first,~     third, and fifth dose will be given at the outpatient clinic. The second and fourth doses can~     be given either at the clinic or by the patients' primary hematologists.~      All patients will be followed as outpatients at 3-month intervals for the first year, and~     then every 6 months for the next 3 years. Afterward, follow-up will be yearly. A small sample~     of blood will be drawn at the visits. Also, bone marrow examinations will be requested at the~     6-month intervals for the first 3 years of treatment. If the treatment that patients are~     assigned to does not work, after 6 months, they will be eligible to receive the other~     treatment-provided that they have complied with the required blood tests and visits to the~     clinic required to assess the patients' safety.~   "
266826|NCT00072956|"~     This study will examine the action of sensory tricks on an occurrence known as surround~     inhibition when there is a disorder of muscle tone affecting a single body part in isolation.~     Surround inhibition refers to a situation that suppresses unwanted movements, known as~     dystonia, in surrounding muscles during voluntary actions. There are tricks-various~     actions-that people use to temporarily stop those unwanted movements. Such tricks can include~     touching the affected body part, placing an object in the mouth, pulling the hair, and~     others. Often these tricks are beneficial early in the illness but become less effective as~     it progresses. This study is guided by a hypothesis that sensory tricks will restore surround~     inhibition and by another hypothesis that it is the application of the tricks, not simply~     sensory input, that is effective in doing that restoring. Emphasis is on cervical dystonia,~     involuntary actions affecting the neck, in which the tricks commonly involve the cheeks and~     chin. The technique used in the study is transcranial magnetic stimulation (TMS).~      Patients ages 18 and older who have cervical dystonia with at least one effective trick and~     patients with no effective trick may be eligible for this study. There will also be a control~     group of healthy participants.~      Participants will be asked to show the sensory trick and may be asked to be videotaped.~     During the TMS procedure, they will be seated in a comfortable chair, with hands placed on a~     pillow on the lap. Small electrodes-soft strips that stick to the skin-will be placed on the~     skin to record the electrical activity of some muscles in the neck that are activated by the~     stimulation from TMS. In TMS, there will be a wire coil held over the scalp. A brief~     electrical current will be passed through the coil, creating a magnetic pulse that stimulates~     the brain. Patients will hear a click and may feel a pulling sensation on the skin under the~     coil. There may be muscle twitches of the face, arm, or leg. In addition, patients may be~     asked to tense certain muscles slightly or perform other simple actions so that the coil can~     be positioned appropriately. Patients will sometimes be asked to bite down and tap their~     teeth slightly for about 1-1/2 minutes at a time. They will be asked to show the sensory~     trick. The stimulation is usually not painful, although sometimes strong contractions of the~     scalp muscles can cause discomfort or a headache. Patients can ask to have the procedure~     discontinued at any time. The testing session takes about 2 hours, done on an outpatient~     basis.~   "
266827|NCT00072865|"~     This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of~     determining the efficacy of the combination in tumor reduction, in patients with locally~     advanced or metastatic breast cancer.~   "
266915|NCT00005046|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of paclitaxel in treating patients who have~     recurrent or persistent ovarian or primary peritoneal cancer.~   "
266828|NCT00072852|"~     The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules~     of single-agent Irinotecan in women with metastatic breast cancer who have experienced~     failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will~     receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3~     week cycles.~   "
266829|NCT00072839|"~     The purpose of the study is to determine whether an investigational compound, ALX-0600, is~     safe and effective in treating Crohn's Disease.~   "
266830|NCT00072787|"~     The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and~     cisplatin that can be administered in gastric cancer patients.~      The purpose of the phase 2 portion of the study is to determine the antitumor activity of the~     S-1 and cisplatin regimen established from phase 1 in patients with advanced gastric cancer.~   "
266831|NCT00072774|"~     To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus~     subjects receiving placebo.~   "
266832|NCT00072761|"~     The goal of this study is to determine the effectiveness of blood transfusion therapy for~     prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.~   "
266833|NCT00072748|"~     This non-randomized, open-label, outpatient clinical trial is designed to assess the safety~     and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal~     cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or~     capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate~     regimens).~      The primary objective of the study is to assess the clinical activity of EKB-569 administered~     orally as a second-line or later stage treatment in subjects with advanced colorectal cancer.~      Secondary objectives include:~        -  To further evaluate the safety of EKB-569~        -  To explore additional clinical activity parameters~        -  To explore subject survival~        -  To evaluate the pharmacokinetics of EKB-569~        -  To assess subject reported outcomes~      EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569~     daily as long as they do not have progressive disease and are tolerating treatment.~   "
266834|NCT00072722|"~     Phase II randomized open-label, two-arm study of safety and efficacy of CC-4047 in subjects~     with metastatic hormone refractory prostate cancer (HRPC)~   "
266835|NCT00017017|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of CT-2103 in treating patients who have~     recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer.~   "
266836|NCT00014677|"~     RATIONALE: NBI-3001 may be able to locate cancer cells and stop them from growing. This may~     be an effective treatment for glioblastoma multiforme.~      PURPOSE: Randomized phase II trial to compare different regimens of NBI-3001 followed by~     surgery to remove the tumor in treating patients who have glioblastoma multiforme.~   "
266837|NCT00014638|"~     RATIONALE: Estrogen can stimulate the growth of cancer cells. Letrozole may fight breast~     cancer by reducing the production of estrogen.~      PURPOSE: Phase IV trial to study the effectiveness of letrozole in treating postmenopausal~     women who have metastatic breast cancer that has been previously treated with tamoxifen.~   "
266838|NCT00014352|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~     Anticoagulant drugs such as warfarin may reduce the risk of blood clots.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus warfarin~     in treating patients who have prostate cancer.~   "
266839|NCT00072826|"~     This study will examine the effects of oral atorvastatin on the linings of blood vessels in~     patients with sickle cell disease, plus the agent's effect on blood markers of inflammation~     and blood vessel function. Sickle cell disease is a recessive genetic disorder and the most~     common genetic disease affecting African Americans. Inherited are abnormal genes that make~     hemoglobin, the substance within red blood cells that carries oxygen from the lungs to the~     body. In the disease, sickle hemoglobin leads to rigidity or hardness of the red cells,~     causing obstruction in small blood vessels, inflammation, and injury to organs when the flow~     of blood to them is blocked. Some medications already prescribed for other diseases, such as~     atorvastatin, which is used for lowering cholesterol levels, can improve blood flow.~      Patients 18 to 65 years of age who have sickle cell disease, who have not had an acute pain~     episode within the previous week, and who are not pregnant or lactating may be eligible for~     this study. They will undergo a complete medical history; physical examination; baseline~     blood tests; and echocardiogram, in which an ultrasound wand is placed against the chest wall~     to get images inside the heart and blood vessels.~      In addition, patients will have blood flow studies. During the procedure, they will lie in an~     adjustable reclining chair for 5 to 6 hours. There will be 20- to 30-minute rests between~     specific activities and blood samples will be drawn intermittently for testing. Small tubes~     will be placed in the artery of the forearm at the inside of the elbow. Normal saline will be~     infused into one tube. A small pressure cuff will be applied to the wrist and a larger cuff~     to the upper arm. Both cuffs will be attached to an inflation device. A device like a rubber~     band, a strain gauge, will be placed around the widest part of the forearm. When the pressure~     cuffs are inflated, blood will flow into the arm, stretching the gauge proportion to blood~     flow, and information will be recorded. Then light reflected from the patients' hand and the~     blood flow in the forearm will be measured. Activity of the genes in the white blood cells~     will be measured as well. Small amounts of sodium nitroprusside, widely used to reduce blood~     pressure in people with dangerously high blood pressure, will be injected and blood flow will~     be measured. Later, small amounts of acetylcholine will be injected. It usually causes blood~     vessels to expand. After that, small amounts of L-NMMA will be injected. It usually decreases~     local blood flow by blocking the production of nitric oxide in the cells lining the arm's~     blood vessels. Then acetylcholine combined with L-NMMA will be injected. After that,~     oxypurinol, an agent taken by many patients to prevent gout, will be injected. The procedures~     will be repeated, with oxypurinol given along with each of the agents, and the measurement of~     blood flow in the forearm will be measured after each drug combination.~      Afterward, patients will be treated for 4 weeks at home with oral atorvastatin. They will be~     asked to visit the Clinical Center every 2 weeks for collection of blood samples and an~     examination. After 4 weeks of taking atorvastatin orally, they will be asked to return to~     repeat the blood flow studies, but only the first half will be conducted. The part using~     oxypurinol will not be needed. Regarding some of the blood samples collected during the~     study, there will be an examination of the genes found in the white blood cells. Specific~     attention will go to those genes that make proteins for cell-to-cell interaction and~     inflammation, plus those that cause blood cells to stick to the lining of blood vessels.~   "
266840|NCT00072813|"~     This study will examine the possible structural and functional abnormalities in patients with~     an inherited form of epilepsy. It will use magnetic resonance imaging (MRI). Uncontrolled~     epilepsy is a serious neurological problem with major harmful medical, social, and~     psychological effects, as well as greater mortality compared with the general population. The~     cost per year in the United States is at least $12.5 billion. There have been advances in~     diagnosing the disease, but the cause cannot be determined in many cases. Recently, several~     seizure syndromes found in families have been described. One syndrome of particular interest~     involves the lateral temporal lobe of the brain and often includes auditory features.~     Patients with that kind of syndrome may hear monotonous unformed sounds, but sometimes they~     may hear complex sounds, such as a song.~      Patients are eligible for this study if they have a specific form of familial epilepsy that~     is being studied at Columbia University in New York. Family members without seizures are~     eligible as well. All the patients in the study will be evaluated at Columbia before~     participating. Healthy volunteers aged 18 to 55 also may be eligible for this study.~      Participants will undergo a medical history and physical examination. During the study, they~     may have three or four sessions of MRI. During the MRI, patients will lie still on a table~     that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning~     time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes.~     Patients may be asked to lie still for up to 60 minutes at a time. As the scanner takes~     pictures, there will be loud knocking noises, and the patients will wear earplugs to muffle~     the sound. Patients will be able to communicate with the MRI staff at all times during the~     scan and may ask to be moved out of the machine at any time. Some scans may be done in a 3~     Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the~     more common 1.5 Tesla scanner. Functional MRI (fMRI) is done while patients are performing~     tasks, such as moving a limb or speaking. Patients will have an opportunity to practice such~     tasks before entering the scanner. The fMRI will take about 1 hour.~   "
266841|NCT00072800|"~     This study, conducted at the National Institutes of Health and the Children's National~     Medical Center, will evaluate how well different physicians agree in how they classify~     cerebral palsy subtypes based on patient examination. Cerebral palsy is divided into several~     subtypes, according to the primary underlying muscle abnormality and its distribution and~     severity. Classification of these subtypes is important for conducting rehabilitation~     research studies on patients with the same type of abnormality. However, doctors do not~     always classify cerebral palsy types in the same way. This study will examine methods for~     improving agreement among doctors in their classification of cerebral palsy subtypes.~      Children between 6 and 18 years of age with cerebral palsy who can voluntarily move their~     arms and legs may be eligible for this study. Participants will be examined by at least three~     doctors or therapists. The examinations take 30-60 minutes. For the examination, a doctor or~     therapist will do the following:~        -  Observe the patient at rest~        -  Gently move the patient's arms and legs and then have the patient move his or her arms~          and legs~        -  Check the patient's reflexes~        -  Observe the patient walking, if the patient is able to walk~      Patients will be asked to remain in the clinic for up to 3 hours while researchers discuss~     the examination and may be asked to repeat part of the study examination.~   "
266842|NCT00072709|"~     This is a global multicenter study designed to evaluate the safety and clinical effects of 4~     oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or~     mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks),~     run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24~     weeks).~   "
266843|NCT00072683|"~     This study’s purpose is to determine whether tolvaptan can safely and effectively return the~     body’s balance of sodium and water toward normal, and to characterize and quantify the~     potential clinical benefits of this treatment.~   "
266844|NCT00072670|"~     The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult~     male participants with advanced metastatic (spread of cancer cells from one part of the body~     to another) prostate cancer.~   "
266845|NCT00012090|"~     RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep~     growing. Goserelin may interfere with the growth factor and may stop the tumor from growing.~     Bicalutamide may prevent androgens from stimulating the growth of cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of goserelin plus bicalutamide in treating~     patients who have refractory or recurrent cancer of the ovary, fallopian tube, or peritoneum.~   "
266846|NCT00010309|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     who have stage II, stage III, or stage IV melanoma.~   "
266847|NCT00008372|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of chloroquinoxaline sulfonamide in~     treating patients who have small cell lung cancer that has not responded to platinum-based~     chemotherapy.~   "
266848|NCT00006367|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral~     stem cell transplantation in treating patients who have myelofibrosis.~   "
266849|NCT00006224|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who~     have persistent or recurrent cancer of the cervix.~   "
266850|NCT00072735|"~     This study will examine the role of an amphetamine in improving the effect that electrical~     nerve stimulation has over brain flexibility associated with motor training in patients who~     experienced a stroke more than 1 year before. Chronic stroke is the main cause of long-term~     disability among adults. Previous studies have shown that electrical stimulation given over~     the skin may improve patients' recovery of motor function. Furthermore, it is known that~     amphetamines can improve the effects of sensory stimulation such as touch. Use dependent~     plasticity refers to a process in which the performance of simple, repetitive finger~     movements leads to encoding the details of those actions in the primary motor cortex of the~     brain. Plasticity in this sense refers to the capacity for change in the brain.~      Patients 18 years of age and older who have had a stroke, who have no history of other~     neurological and psychiatric illnesses, and who are able to contrite and perform simple~     attentional tasks and other tasks may be eligible for this study. There will also be healthy~     participants as a control group.~      Participants will have an electrocardiogram. They will also go through a practice session of~     about 3 hours in which they become familiar with the different tasks required in the study:~     motor training, pinch force, and the Jebsen-Taylor Test-which requires doing as fast as~     possible actions that include writing, lifting small common objects, turning pages, or~     lifting light or heavy objects. Then during the study, patients will be involved in a variety~     of sessions:~        -  Motor training alone for about 3 hours.~        -  Motor training, amphetamine (or placebo), and electrical stimulation for about 6 hours.~        -  Motor training, amphetamine, and no electrical stimulation for about 6 hours.~      A magnetic resonance imagining (MRI) scan will be done. Patients will lie still on a table~     that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning~     time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes.~     Patients may be asked to lie still for up to 60 minutes at a time. As the scanner takes~     pictures, there will be loud knocking noises, and the patients will wear earplugs to muffle~     the sound. Patients will be able to communicate with the MRI staff at all times during the~     scan and may ask to be moved out of the machine at any time.~      During another procedure called transcranial magnetic stimulation (TMS), a wire coil will be~     held over the scalp. A brief electrical current will be passed through the coil, creating a~     magnetic pulse that stimulates the brain. Patients will hear a click and may feel a pulling~     sensation on the skin under the coil. There may be muscle twitches of the face, arm, or leg.~     Patients may be asked to tense certain muscles slightly or perform other simple actions so~     that the coil can be positioned appropriately. The stimulation is usually not painful,~     although sometimes strong contractions of the scalp muscles can cause discomfort or a~     headache. Patients can ask to have the procedure discontinued at any time.~      For the electrical stimulation procedure, three pairs of electrodes will be placed on the~     skin. A quite brief pulse of current will pass between the electrodes, creating the~     electrical field that activates the brain. Patients will feel a brief stinging around the~     electrodes. Regarding the amphetamine, patients will take it orally on up to four different~     occasions. Usually they will take 10 mg of Dexedrin before testing.~   "
266851|NCT00072657|"~     Rheumatoid arthritis (RA) is a chronic illness. Patients with RA often experience significant~     pain and depression. This study will evaluate two programs designed to improve the symptoms~     of RA: cognitive-behavioral therapy (CBT) and Tai Chi Chih (TCC), compared to a health~     education seminar.~   "
266852|NCT00072644|"~     This study will evaluate the impact of the HIV protease inhibitor ritonavir on the~     pharmacokinetics-that is, the interaction of the medication and the body-of prednisolone~     after prednisone is given to healthy volunteers. Prednisone, an agent known as a~     corticosteroid, or steroid hormone, is converted by the body into prednisolone. Ritonavir is~     an HIV medication that fights the virus by blocking its ability to reproduce. Sometimes it~     increases the blood levels of other drugs given at the same time, and it is possible that~     ritonavir increases the blood levels of prednisolone and those of other medications. Results~     from the study will provide information on whether prednisone and ritonavir interact in a~     potentially harmful way. The MDR1 genotype, that is, part of a person's genetic constitution,~     may influence how prednisolone behaves.~      Patients 18 to 50 years of age who are in good health, who not have HIV, and who do not smoke~     may be eligible for this study. There will be 10 participants and another 5 later who will be~     control subjects. Those in the control group will take only prednisone, not ritonavir.~      Participants will undergo the following tests and procedures:~        -  Medical history and physical examination.~        -  Collection of blood and urine to assess general health.~        -  Collection of blood to examine markers on white blood cells and to determine the kind of~          MDR1 gene was inherited.~        -  HIV test.~      The screening visit will take about 3 to 4 hours, and the study will take about 28 to 49~     days. For 3 study days, participants will remain in the clinic for 12 hours, On Study Day 1,~     patients will be asked to not eat or drink anything besides water before coming to the~     clinic. Blood samples will be collected to measure prednisolone concentration as well as~     osteocalcin, a blood protein involved in bone formation. Blood tests will also allow a look~     at the surfaces of some white blood cells. Patients will receive a breakfast along with 20 mg~     of prednisone. Urine samples will be collected also. Then patients will be dismissed and~     asked to collect urine samples and return them on the following morning, Study Day 2. At that~     time there will additional blood collection. Patients will begin taking ritonavir between 7~     and 28 days after the first dose of prednisone, at a dose of 200 mg (two 100 mg capsules)~     twice daily with food, to continue for 15 days. On the 4th and 14th days of their taking~     ritonavir, patients will be asked to visit the clinic in the morning for a blood to measure~     ritonavir in the blood and to take a single 20-mg dose of prednisone along with the~     ritonavir. Both medications will be taken with breakfast. Blood and urine levels of~     prednisolone will also be measured. On the 15th day of ritonavir dosing, there will be~     another blood collection for routine lab tests, as well as studies on blood cells and~     osteocalcin.~   "
266853|NCT00072631|"~     The purpose of this study is to determine if erlotinib will improve disease at doses that~     produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.~   "
266854|NCT00072618|"~     The purpose of this study is to determine if the combination of Taxotere and exisulind is an~     effective and safe treatment for patients with advanced NSCLC who have failed a prior~     platinum-containing regimen.~   "
266855|NCT00072501|"~     RATIONALE: Screening tests such as ultrasound and mammography may help doctors detect cancer~     cells early and plan more effective treatment for breast cancer. It is not yet known whether~     ultrasound is more effective than mammography in detecting breast cancer.~      PURPOSE: This clinical trial is studying breast ultrasound to see how well it works compared~     to mammography in detecting cancer in women who are at high risk for breast cancer.~   "
266856|NCT00072488|"~     RATIONALE: New imaging procedures, such as whole-body MRI, may improve the ability to detect~     metastatic cancer and determine the extent of disease.~      PURPOSE: This clinical trial is studying whole-body MRI to see how well it works compared to~     standard imaging procedures in detecting distant metastases in patients with solid tumors or~     lymphoma.~   "
266857|NCT00072475|"~     RATIONALE: Vatalanib may be effective in preventing the development of leukemia in patients~     who have myelodysplastic syndromes.~      PURPOSE: This phase II trial is studying vatalanib to see how well it works in treating~     patients with primary or secondary myelodysplastic syndromes.~   "
266858|NCT00072462|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It~     is not yet known whether tamoxifen is more effective than anastrozole in preventing breast~     cancer after surgery for ductal carcinoma in situ.~      PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works~     compared to anastrozole in treating postmenopausal women who have undergone surgery to remove~     ductal carcinoma in situ.~   "
266859|NCT00072449|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have~     refractory or relapsed primary CNS lymphoma.~   "
266860|NCT00072436|"~     This phase I trial is studying the side effects and best dose of gemcitabine hydrochloride~     and alvocidib in treating patients with solid tumors. Drugs used in chemotherapy, such as~     gemcitabine hydrochloride and alvocidib, use different ways to stop tumor cells from dividing~     so they stop growing or die. Combining more than one drug may kill more tumor cells~   "
266861|NCT00072410|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive~     tumor-killing substances to them without harming normal cells. Giving radiolabeled monoclonal~     antibody directly into the abdominal cavity may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of giving radiolabeled monoclonal antibody~     therapy directly into the abdominal cavity in treating patients who have advanced ovarian~     epithelial cancer.~   "
266862|NCT00072384|"~     Phase III trial to determine the effectiveness of combining systemic chemotherapy and~     subtenon carboplatin with ophthalmic therapy in treating children who have intraocular~     retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide,~     work in different ways to stop tumor cells from dividing so they stop growing or die. It is~     not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye)~     carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the~     eyeball) retinoblastoma.~   "
266863|NCT00072358|"~     RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells.~     Colony-stimulating factors, such as sargramostim, may increase the number of immune cells~     found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim~     may cause a stronger immune response and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with~     sargramostim in treating patients who have neuroblastoma.~   "
266864|NCT00072345|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use different ways~     to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the~     growth of cancer by stopping blood flow to the tumor. Combining temozolomide and thalidomide~     with lomustine may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide~     with lomustine in treating patients who have unresectable stage III or stage IV melanoma.~   "
266865|NCT00072332|"~     RATIONALE: Drugs used in chemotherapy, such as edotecarin and cisplatin, use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining edotecarin with~     cisplatin may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining edotecarin with cisplatin in~     treating patients who have advanced or metastatic solid tumors.~   "
266866|NCT00072319|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and paclitaxel,~     use different ways to stop tumor cells from dividing so they stop growing or die. Giving~     chemotherapy drugs before surgery may shrink the tumor so that it can be removed during~     surgery. Giving chemotherapy drugs after surgery may kill any remaining tumor cells.~      PURPOSE: Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin,~     cyclophosphamide, and paclitaxel in treating women who have stage I, stage II, or stage III~     breast cancer.~   "
266867|NCT00072293|"~     RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node~     micrometastases may remove cancer cells that have spread from tumors in the breast. It is not~     yet known whether surgery to remove the primary tumor is more effective with or without~     axillary lymph node dissection.~      PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node~     dissection to see how well they work compared to surgery alone in treating women with~     node-negative breast cancer and sentinel lymph node micrometastases.~   "
266868|NCT00072280|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Giving combination chemotherapy before surgery may~     shrink the tumor so that it can be removed. Giving combination chemotherapy after surgery may~     kill any remaining tumor cells.~      PURPOSE: This phase II trial is studying how well surgery and/or combination chemotherapy~     work in treating children with fibrosarcoma.~   "
266869|NCT00072267|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop~     tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor~     cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in~     treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial,~     primary peritoneal, or fallopian tube cancer.~   "
266870|NCT00072228|"~     RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining more than one drug~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of soblidotin and~     gemcitabine in treating patients with locally advanced or metastatic solid tumors.~   "
266871|NCT00072215|"~     RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and~     vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether ifosfamide and cisplatin are more effective when combined~     with paclitaxel or vinblastine in treating germ cell tumors.~      PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to~     see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men~     with progressive or recurrent metastatic germ cell tumors.~   "
266872|NCT00072189|"~     UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.~     This phase II trial is studying how well UCN-01 works in treating patients with metastatic~     melanoma.~   "
266873|NCT00072176|"~     This phase II trial studies how well temsirolimus works in treating patients with endometrial~     cancer that has spread to other parts of the body or has spread from where it started to~     nearby tissue or lymph nodes and has come back after a period of time during which the cancer~     could not be detected. Temsirolimus may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
266874|NCT00072163|"~     This phase II trial is studying how well giving temozolomide together with thalidomide works~     in treating patients with brain metastases secondary to melanoma. Drugs used in chemotherapy,~     such as temozolomide, work in different ways to stop tumor cells from dividing so they stop~     growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the~     tumor. Combining temozolomide with thalidomide may kill more tumor cells~   "
266875|NCT00072150|"~     Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor~     cell growth. This phase II trial is studying how well bortezomib works in treating patients~     with advanced transitional cell carcinoma of the urothelium.~   "
266876|NCT00072137|"~     This phase I trial studies the side effects and best dose of vaccine therapy given directly~     into the bladder in treating patients who are undergoing surgery to remove all or part of the~     bladder. Vaccines made from a gene-modified virus may help the body build an effective immune~     response to kill tumor cells. Giving a vaccine directly into the bladder before surgery may~     cause a stronger immune response and keep tumor cells from coming back after surgery.~   "
266877|NCT00072124|"~     RATIONALE: Drugs used in chemotherapy, such as dacarbazine and cisplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Complete metastasectomy~     may be an effective treatment for metastatic melanoma and may improve quality of life and~     help patients live longer and more comfortably. It is not yet known whether complete~     metastasectomy is more effective than chemotherapy in treating stage IV melanoma.~      PURPOSE: This randomized phase III trial is studying dacarbazine and/or cisplatin to see how~     well they work compared to complete metastasectomy in treating patients with stage IV~     melanoma.~   "
266878|NCT00072111|"~     RATIONALE: Biological therapies, such as anakinra, may interfere with the growth of the tumor~     cells and slow the growth of metastatic tumors that express the interleukin-1 gene.~      PURPOSE: This phase I trial is studying the side effects and best dose of anakinra in~     treating patients with metastatic cancer that expresses the interleukin-1 gene.~   "
266879|NCT00072098|"~     RATIONALE: Inserting the interleukin-12 gene into a person's cancer cells may make the body~     build an immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 gene~     when injected into the tumors of patients with liver metastases secondary to colorectal~     cancer.~   "
266880|NCT00072085|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: This randomized phase II trial is studying immunization using two different gp100~     protein vaccines to compare how well they work in treating patients with metastatic melanoma.~   "
266881|NCT00072072|"~     RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor.~     Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth. Combining celecoxib with erlotinib may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when~     given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell~     lung cancer.~   "
266882|NCT00072059|"~     RATIONALE: Ro 50-3821 may stimulate red blood cell production and treat anemia in patients~     who are receiving antineoplastic therapy for non-small cell lung cancer.~      PURPOSE: This randomized phase II trial is studying six different regimens of Ro 50-3821 to~     compare how well they work in treating anemia in patients who are receiving antineoplastic~     therapy for stage IIIB or stage IV non-small cell lung cancer.~   "
266883|NCT00072046|"~     RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of~     tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the~     tumor. It is not yet known whether interferon alfa-2b is more effective with or without~     bevacizumab in treating advanced renal cell carcinoma (kidney cancer).~      PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to~     see how well they work compared to interferon alfa-2b alone in treating patients with~     advanced renal cell carcinoma.~   "
266884|NCT00072033|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to~     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation~     therapy before surgery may shrink the tumor so that it can be removed.~      PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together~     with chemoradiotherapy followed by surgery works in treating patients with locally advanced,~     resectable esophageal cancer.~   "
266885|NCT00072020|"~     RATIONALE: Zoledronate may delay or prevent the formation of bone metastases. It is not yet~     known whether chemotherapy and/or hormone therapy are more effective with or without~     zoledronate in preventing cancer recurrence and bone metastases in women with breast cancer.~      PURPOSE: This randomized phase III trial is studying giving chemotherapy and/or hormone~     therapy together with zoledronate to see how well they work compared to chemotherapy and/or~     hormone therapy alone in preventing cancer recurrence and bone metastases in women with stage~     II or stage III breast cancer.~   "
266886|NCT00072007|"~     RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer~     cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab,~     can locate cancer cells and either kill them or deliver cancer-killing substances to them~     without harming normal cells. Combining cladribine with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving cladribine and rituximab as~     remission induction therapy together with rituximab and stem cell mobilization in treating~     patients with chronic lymphocytic leukemia.~   "
266887|NCT00071994|"~     Phase II trial to study the effectiveness of gefitinib in treating patients who have advanced~     unresectable hepatocellular carcinoma (liver cancer). Gefitinib may stop the growth of tumor~     cells by blocking the enzymes necessary for their growth~   "
266888|NCT00071981|"~     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill~     tumor cells.~      PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma~     peptides from cytotoxic T cells and helper T cells to see how well they work in treating~     patients with metastatic melanoma.~   "
266916|NCT00004206|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin and fluorouracil~     in treating patients who have recurrent ovarian cancer.~   "
266889|NCT00071968|"~     RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor~     cells from dividing so they stop growing or die. Giving CCI-779 before surgery may shrink the~     tumor so that it can be removed.~      PURPOSE: This randomized phase II trial is studying how well CCI-779 works in treating~     patients who are undergoing radical prostatectomy for newly diagnosed prostate cancer at high~     risk of relapse.~   "
266890|NCT00071955|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Vaccines made~     from a person's cancer cells may make the body build an immune response to kill cancer cells.~     Colony-stimulating factors such as sargramostim may increase the number of immune cells found~     in bone marrow or peripheral blood.~      PURPOSE: Phase II trial to study the effectiveness of rituximab followed by vaccine therapy~     and sargramostim in treating patients who have refractory or progressive non-Hodgkin's~     lymphoma.~   "
266891|NCT00071942|"~     Vaccines may make the body build an immune response to kill tumor cells. This phase I trial~     is studying the side effects and best dose of vaccine therapy in treating patients with~     metastatic breast cancer.~   "
266892|NCT00071929|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who~     have persistent or recurrent endometrial cancer.~   "
266893|NCT00003141|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral~     stem cell transplantation in treating infants with malignant brain or spinal cord tumors.~   "
266894|NCT00072605|"~     This study will test the safety of an experimental vaccine developed to protect against Ebola~     virus infection and to determine if the vaccine induces an immune response to the virus. The~     Ebola virus causes a disease called Ebola hemorrhagic fever. Symptoms begin with fever and~     muscle aches and progress to breathing problems, severe bleeding, kidney problems, and shock.~     The infection may be mild, but it can also lead to death. The vaccine used in this study is~     made from small parts of Ebola genetic material. It cannot cause Ebola hemorrhagic fever to~     develop in those who receive it.~      Healthy volunteers 18 to 44 years of age may be eligible for this study. Candidates will be~     screened with a medical history, physical examination, and laboratory tests, and complete an~     assessment of understanding questionnaire to show that they understand the study.~      Depending on their order of entry into the study, participants are assigned to receive one of~     three vaccine doses or placebo. The first group receives the lowest dose (2 milligram) of~     vaccine or placebo. If this dose is safe, then the second group receives 4 mg, and if this~     dose is safe, the third group receives 8 mg. Injections are given in a muscle in the upper~     arm. Participants receive three injections, each 4 weeks apart (on study days 0, 28, and 56).~      Participants record their temperature and symptoms in a diary card for 7 days following each~     injection. They return to the clinic 2 to 3 days after each injection and then 2 weeks after~     each injection until study week 10. Additional follow-up visits are then scheduled at weeks~     12, 24, 38, and 52. At each visit, participants provide a blood and urine sample for testing~     and have their vital signs, and lymph nodes checked, their weight measured, and their~     symptoms reviewed. Additional laboratory tests may be requested between visits.~   "
266895|NCT00072592|"~     This study will examine the use of rituximab in patients with Wegener's granulomatosis (WG)~     who have experienced a relapse of the disease through standard therapies. Rituximab is an~     antibody directed against the human protein called CD20, found on the surface of normal and~     abnormal B lymphocytes. Rituximab decreases the number of B lymphocytes. This study will~     examine the safety of rituximab in WG and rituximab's ability to reduce the level of~     circulating antineutrophil cytoplasmic antibodies (ANCA), which are antibodies that react to~     substances found in white blood cells. ANCA have been found to be strongly associated with~     WG. The study will also explore whether rituximab can reduce the occurrence of disease~     relapse. WG is a disease marked by inflammation of blood vessels. It can involve many~     different parts of the body, including the sinuses, lungs, kidneys, brain, nerves, eyes,~     intestinal tract, skin, joint, heart, and others. Before the use of cytotoxic drug therapy,~     WG was almost always fatal if untreated, with a mortality rate of 93% within 2 years.~      Patients 18 to 75 years of age who have a history of at least one relapse of the disease~     despite standard treatments, who have had active WG within the previous 12 months and are in~     remission, who are receiving either methotrexate or azathioprine for remission maintenance,~     and who have circulating ANCA, may be eligible for this study.~      A minimum of 22 visits to the clinic will be required to complete the entire study. Patients~     will undergo a comprehensive medical evaluation, with laboratory studies and x-rays. There~     may also be consultations and possible biopsies of affected organs only if medically~     indicated for diagnosis and treatment of the disease. In the 4-week period that patients will~     receive rituximab infusions, the methotrexate or azathioprine will be continued at the same~     dosage unless there are side effects that requite the medication to be temporarily stopped or~     the dosage reduced. Patients will receive four doses of rituximab, at 375 mg per meter~     squared of body surface area, once a week. It will be infused into a vein, through an~     intravenous catheter. For the first dose, patients will be admitted as inpatients for at~     least 24 hours, for monitoring during the infusion and for any reactions associated with it.~     The second, third, and fourth rituximab infusions may be given either on an inpatient or~     outpatient basis to be decided on how the patient tolerates the first infusion.~      Following the four infusions, there will be blood tests to monitor the safety of the~     medication and the status of the disease, to be done at home every week for 4 weeks. Results~     will be sent to the researchers by fax. Patients will be asked to return to the clinic 1~     month after the fourth infusion and every 1 to 3 months afterward. If there are no side~     effects or a relapse of the disease, the methotrexate or azathioprine will be continued for 2~     years past remission. If by then the disease then remains in remission, the dose of either~     medication will be gradually decreased and eventually stopped. The usual schedule is to~     reduce methotrexate by 2.5 mg per month and to reduce azathioprine by 25 mg per month. If at~     that point there are no signs of active disease, the patients' illness will be considered to~     be in continued remission and no further treatment will be necessary. If relapse does occur,~     treatment would be different than previously. In most cases, treatment would involve~     prednisone and cyclophosphamide or methotrexate If the ANCA finding is negative after~     rituximab treatment and again becomes positive, and there is evidence of a return of B~     lymphocytes, patients may receive a second course of four rituximab infusions.~   "
266896|NCT00072579|"~     RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of~     immune cells found in bone marrow or peripheral blood and may bring about complete remission~     in patients who have chronic phase chronic myelogenous leukemia.~      PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating~     patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic~     remission after initial treatment.~   "
266897|NCT00072566|"~     This phase II trial is to see if combining bevacizumab with low-dose cyclophosphamide works~     in treating patients with ovarian epithelial or primary peritoneal cancer that has come back~     or spread to other parts of the body. Monoclonal antibodies, such as bevacizumab, can block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or deliver cancer-killing substances to them.~     Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor~     cells from dividing so they stop growing or die. Combining bevacizumab with cyclophosphamide~     may kill more tumor cells.~   "
266898|NCT00072553|"~     RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, use~     different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may~     stop the growth of colorectal cancer by stopping blood flow to the tumor and by blocking the~     enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining celecoxib with leucovorin,~     fluorouracil, and oxaliplatin in treating patients who have metastatic colorectal cancer.~   "
266899|NCT00072540|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. Celecoxib may be effective in preventing cervical cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing~     cervical cancer in patients who have high-grade squamous intraepithelial lesions of the~     cervix.~   "
266900|NCT00072527|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and~     etoposide, use different ways to stop tumor cells from dividing so they stop growing or die.~     Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with~     radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cisplatin and irinotecan followed by~     carboplatin, etoposide, and radiation therapy in treating patients who have limited-stage~     small cell lung cancer.~   "
266901|NCT00072514|"~     This pilot phase II trial studies the side effects and how well giving gemcitabine~     hydrochloride, carboplatin, dexamethasone, and rituximab together works in treating patients~     with previously treated lymphoid malignancies. Drugs used in chemotherapy, such as~     gemcitabine hydrochloride, carboplatin, and dexamethasone, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Giving more than one drug (combination~     chemotherapy) and giving monoclonal antibody therapy with chemotherapy may kill more cancer~     cells~   "
266969|NCT00024206|"~     Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced~     solid tumors. SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor~   "
266902|NCT00071916|"~     The purpose of this study is to evaluate a group of African Americans and Caucasians with~     hepatitis C virus (HCV), compare their response rates to combination treatment with pegylated~     interferon alfa-2b and ribavirin, and identify possible causes for racial differences in~     response to therapy. The study will enroll a total of 260 participants, age 18 or older, over~     a 10 period. In the next 5 years 132 subjects will be studied locally, including 112 African~     Americans and 20 Caucasians. Participants will be recruited from the clinical practices of~     the hepatologists (liver doctors) at the University of Tennessee Health Science Center and~     will also be selected from referrals at local hepatology clinics and the Memphis VA Hospital.~     Volunteers will be treated with pegylated interferon alfa-2b injections once weekly and oral~     ribavirin 2 times a day for up to 72 weeks. Study procedures include multiple blood draws.~     Participants may be involved in study related procedures for up to 72 weeks.~   "
266903|NCT00071851|"~     The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine,~     VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will~     be tested.~   "
266904|NCT00071812|"~     The purpose of this study is to evaluate the safety and efficacy of 3 different doses of~     belimumab, administered in addition to standard therapy, in patients with rheumatoid~     arthritis (RA).~   "
266905|NCT00071799|"~     The purpose of this study is to determine whether patients with high-risk myelodysplastic~     syndromes (MDS) treated with azacitidine have improved survival compared to conventional care~     treatments. The study will also assess the effect of treatments on response, duration of~     response, and transformation to acute myeloid leukemia (AML). The study will continue for 12~     months following last patient enrolled.~      See study AZA PH GL 2003 CL 001 E for information about the extension to this study.~   "
266906|NCT00006008|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have relapsed or refractory acute lymphoblastic leukemia.~   "
266907|NCT00005964|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells. It is not yet known which combination chemotherapy regimen is most effective in~     treating aggressive non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients who have previously untreated aggressive stage II,~     stage III, or stage IV non-Hodgkin's lymphoma.~   "
266908|NCT00005962|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate~     cancer cells and either kill them or deliver cancer-killing substances to them without~     harming normal cells. Combining more than one drug or combining monoclonal antibody with~     chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more~     effective for acute myelogenous leukemia.~      PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens~     in treating patients who have relapsed or refractory acute myelogenous leukemia.~   "
266909|NCT00005576|"~     Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing~     substances to them without harming normal cells. Colony-stimulating factors such as~     sargramostim may increase the number of immune cells found in bone marrow or peripheral~     blood. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.~     Combining monoclonal antibody therapy with sargramostim or interleukin-2 may kill more tumor~     cells. Phase I trial to study the effectiveness of monoclonal antibody therapy given with~     sargramostim and interleukin-2 in treating children with neuroblastoma who have just~     completed bone marrow or peripheral stem cell transplantation~   "
266910|NCT00005094|"~     Chemoprevention therapy is the use of certain drugs to try to prevent the development of~     cancer. The use of celecoxib has been approved for use in reducing the number of adenomatous~     colorectal polyps in familial adenomatous polyposis (FAP). It is not known whether there is a~     clinical benefit from a reduction in the number of colorectal polyps in FAP patients. The use~     of celecoxib may be an effective way to prevent the development of sporadic adenomatous~     polyps, precursors of colorectal cancer. This randomized phase III trial is studying~     celecoxib to see how well it works compared to a placebo in preventing the development of~     adenomatous colorectal polyps in patients who have had at least one polyp removed.~   "
266911|NCT00071903|"~     This study will examine whether the tendency to have thrombosis, or the formation of blood~     clots inside blood vessels, has a role in the development of pseudotumor cerebri (PTC). PTC~     causes symptoms and signs of isolated elevated blood pressure in the cranium, or covering of~     the brain. The disorder can lead to significant, negative effects on the visual system.~     Increased pressure of the cerebrospinal fluid, that is, fluid around the brain, is a factor,~     but the cause of the disorder is not clear. There has been documentation of clustering of PTC~     within families. It suggests that potential genetic polymorphisms-abilities to take on~     different forms-may become evident after exposure to conditions known to trigger PTC.~      Thrombosis comes about by interactions between genetic and environmental or acquired factors,~     or both, resulting in a blood clot at a specific time and location. Because the disease~     occurs in episodes, the interaction of the genetic and nongenetic risk factors is important.~     Cystinosis is a recessive disorder caused by deposits of cystine within the lysosomes of~     cells-that is, sac-like cell parts that contain various enzymes. Involvement of the kidneys~     remains the primary characteristic, eventually leading to renal failure. Of all of the risk~     factors that make it easier for blood clotting, a high level of a substance called~     homocysteine is of particular interest. Too much homocysteine in blood plasma is a common~     finding in patients with kidney failure, and it has been recently identified as an~     independent risk factor for diseases of the blood vessels.~      Participants of all ages who meet the Dandy criteria for PTC may be eligible for this study.~     Pregnant women will be excluded. There will also be a control group of nephropathic~     cystinosis patients who do not have PTC.~      Participants will be asked to undergo the following tests and procedures:~        -  Medical history.~        -  Physical examination, to evaluate the eye and nervous systems.~        -  Collection of blood for DNA and other tests.~        -  Collection of cerebrospinal fluid, through a procedure called lumbar puncture or spinal~          tap.~      The evaluation of patients will generally last 3 to 4 days. For the collection of~     cerebrospinal fluid, the patient's skin on the back will be numbed with a local anesthetic. A~     special needle will be inserted into the back, and a small amount of the fluid will be drawn~     through the needle. There will be pain for a minute, although there can be a headache lasting~     24 hours. Also, there may be bruising, local pain, bleeding, or infection where the needle~     enters. Patients may also have a magnetic resonance imaging scan of their head. During the~     MRI scan, patients will lie still on a table that slides in and out of a metal cylinder~     surrounded by a strong magnetic field. Patients will be able to communicate with the MRI~     staff at all times and may ask to be moved out of the machine at any time.~   "
266912|NCT00071890|"~     This study will examine whether interleukin-2 (IL-2) given before the interruption of~     antiretroviral (ARV) treatment could significantly extend the period of time that a patient~     is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per~     microliter. There will be an evaluation of the toxicity, or extremely harmful effects, of~     ARV, and the effect on quality of life.~      The use of ARV medications has greatly improved the condition and mortality of HIV-infected~     patients. But when used long term, those medications have been associated with great~     toxicities and medication fatigue. As a result, patients may not adhere to ARV use, and~     resistance to viruses may grow. The CD4 molecule is on the surface of helper T-lymphocytes,~     or T-helper cells. It serves as the primary receptor for HIV-1 and HIV-2, allowing the virus~     to gain entry into its host. The CD4 count increases immediately in response to ARV, giving~     an estimate of the state of a patient's immune system. Thus, it is a strong marker of the~     immediate risk of an opportunistic infection, one that takes advantage of a person's weakened~     immune system. IL-2 is a molecule naturally produced by activated T cells. In patients with~     HIV, IL-2 treatment can increase CD4 counts but the clinical importance of this increase is~     not clear. This study will compare the decline in CD4 count, when ARV is interrupted, in two~     random groups of participants: (1) those who will receive three cycles of IL-2 (one every 8~     weeks) in combination with ARV therapy for the first 24 weeks of the study before stopping~     ARV and (2) those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV.~      Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy~     for at least 1 year, and who currently have a CD4 count 500 cells per microliter or higher~     and never had a CD4 count of less than 200 cells per microliter and a viral load less than~     the limit of detection, may be eligible for this study.~      Participants will undergo the following procedures and tests:~        -  Physical examination.~        -  Blood tests to measure blood lipids (fats), sugar, complete blood count including~          platelets, and chemistries.~        -  Assessment of fat distribution.~        -  Questionnaire about quality of life.~      In addition, those participants who are randomly placed in the group receiving IL-2 and ARV~     will get an echocardiogram at the beginning of the study and at week 24. They will receive a~     starting dose of 6 million units of IL-2 as an injection under the skin twice a day. Each of~     the three IL-2 cycles will last 5 days. After the 24-week period, participants in both groups~     will stop taking ARV medications if their CD4 count is still equal to or greater than 500~     cells per microliter. The study will continue into 120 weeks. Participants will be asked to~     continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts.~     Every 24 weeks, they will be asked to answer a questionnaire about their quality of life.~     Blood tests and other measurements will also be done as follow-up.~   "
266913|NCT00071877|"~     This study will evaluate the safety of multiple biweekly intravenous doses of Replagal over~     26 weeks in 25 children with Fabry disease and the way in which that agent can improve the~     health of this patient population. Fabry disease is a genetic disorder inherited as an~     X-linked recessive trait. It causes a deficiency in the enzyme alpha galactosidase, which~     normally breaks down a lipid, or fatty substance, called ceramidetrihexosidase, a building~     block in all cells of the body.~      The deficiency in breaking down the lipid eventually causes that lipid to accumulate and~     injure cells. Problems in the blood vessels, kidneys, heart, and nerves are the result. The~     disease typically occurs in childhood or adolescence, with repeated episodes of severe pain~     in the extremities and other symptoms. There is no definitive treatment, but pain management~     is important in caring for patients with Fabry disease. Although it is not known exactly how~     lipid accumulation brings about such problems, studies of another lipid storage disorder,~     Gaucher's disease, have shown that the illness can be reversed if the lipid is removed when~     an appropriate enzyme, Replagal, is given intravenously. In this study, the gene response of~     the body's cells to Fabry disease will be described, as will any gene responses that change~     when the enzyme is used.~      Patients 7 to 17 years of age who have Fabry disease may be eligible for this study. They~     will undergo the following tests and procedures:~        -  Physical examination.~        -  Neurological examination.~        -  Vital signs.~        -  Urinalysis.~        -  Blood tests to determine complete blood count and chemistries.~        -  Questionnaire on pain.~        -  Tests pertaining to sweating.~        -  Electrocardiogram.~        -  Doppler blood flow study.~        -  Diary for recording symptoms and the use of pain medications.~      Participants will go through the evaluation, over a period of about 5 days, either as an~     inpatient or outpatient. Participants will receive an intravenous infusion of Replagal every~     other week, at the dose of 0.2 mg/kg of body weight. Vital signs will be measured before the~     infusion and immediately and after and 1 hour afterward. There will be careful monitoring for~     allergic reactions and side effects. The infusion time takes approximately 40 minutes.~      This study will last 6 months, with the possibility of being extended another 6 months-a~     maintenance study in which patients will continue to receive Replagal at the same dose every~     2 weeks.~   "
266914|NCT00005072|"~     RATIONALE: Inserting the gene for interleukin-2 into a person's prostate cancer cells may~     make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of Leuvectin in treating patients who~     have locally recurrent prostate cancer after receiving treatment with radiation therapy.~   "
266917|NCT00004093|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy and radiation therapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus~     radiation therapy in treating patients who have stage III non-small cell lung cancer.~   "
266918|NCT00071838|"~     This study will examine the safety of Zenapax (daclizumab) in patients with multiple~     sclerosis (MS). MS is thought to be caused by an over-reactive immune response. T-lymphocytes~     (cells of the immune system), are thought to damage myelin, a substance that covers the nerve~     and parts of the spinal cord and is damaged in patients with MS. Interleukin-2 is a natural~     substance in the body that is necessary for the growth of T-lymphocytes. Zenapax is a~     genetically engineered antibody that blocks the activity of interleukin-2 and thus interferes~     with the growth of lymphocytes. Therefore, Zenapax may prevent some of the damage to myelin~     that occurs in multiple sclerosis.~      Patients between 18 and 65 years of age with relapsing remitting MS may be eligible for this~     study. Patients with secondary-progressive or primary progressive MS may not participate.~     Candidates will be screened with a complete neurological and medical evaluation and review of~     medical records.~      Participants will undergo the following tests and procedures:~        -  Baseline evaluation: Participants have four magnetic resonance imaging (MRI) scans over~          a 3-month period to assess disease activity. For the MRI scans, the patient lies on a~          table that slides into the scanner - a narrow metal cylinder with a strong magnetic~          field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between~          45 and 90 minutes. Only patients with activity at or above a certain level are eligible~          to continue with the treatment phase of the study.~        -  Zenapax treatment: Patients receive intravenous (through a vein) infusions of Zenapax.~          The first two infusions are 2 weeks apart, followed by 13 monthly infusions.~        -  MRI scans: Patients undergo MRI scanning before every infusion to evaluate disease~          activity and identify new brain lesions.~        -  Blood and urine tests: Blood and urine samples are collected at each clinic visit for~          routine laboratory evaluations, immunologic study, and genetic testing to determine a~          predisposition for responding to Zenapax treatment.~        -  Lumbar puncture (spinal tap): This procedure will be done during the last month before~          starting treatment and during the seventh month of treatment to examine immune changes~          that occur in the cerebrospinal fluid (CSF), which circulates through and surrounds the~          brain and spinal cord. A local anesthetic is given and a needle is inserted in the space~          between the bones in the lower back where the CSF circulates below the spinal cord. A~          small amount of fluid is collected through the needle.~        -  Skin test: A needle is placed just under the skin is done to assess the patient's immune~          status to common antigens such as tetanus, mumps and candida.~        -  Lymphocytopheresis: Lymphocytes are collected three times - once during the last month~          of baseline before starting treatment, once during the fifth month of treatment, and~          once during the last month of treatment - for immunologic study. Blood is collected~          through a needle in an arm vein in a similar way to donating blood. The blood flows from~          the vein through a catheter (plastic tube) into a machine that separates it into its~          components by centrifugation (spinning). The lymphocytes are removed and the rest of the~          blood (red cells, plasma and platelets) is returned to the body, either through the same~          needle or through another needle in the other arm.~   "
266919|NCT00071773|"~     This pilot study will compare the use of current laser treatment for diabetic macular edema~     with a similar laser treatment that is milder in intensity, but more extensive.~   "
266920|NCT00071786|"~     This study will examine how depression, anxiety, and migraine run in families. It will help~     in defining the risk factors for physical, mental, and health problems-as well as define ways~     that those problems may be prevented and treated.~      A broad range of ages among family members will be included to evaluate the patterns of how~     these disorders are expressed throughout people's lives. Children of all ages will be~     included, and those ages 8 to 17 will be interviewed directly.~      Assessments will be collected through criteria of the Diagnostic and Statistical Manual of~     Mental Disorders IV as well as the spectrum, or range, of mood disorders and co-existing~     conditions. A member of the study team will visit the participants at home or will do an~     interview by telephone. Participation will take approximately 3 to 4 hours. Children will~     complete questionnaires given by the research team as well as questionnaires that they will~     do by themselves. The questions will pertain to the children's health, including physical and~     mental health and medical history, social relationships, problems, skills, and ways of~     dealing with important or stressful issues in their lives. These questionnaires will take up~     to 1 hour to complete.~      Health history gathered from adult participants will pertain to height, weight, exercise, and~     general function. Women will be asked about the use of oral contraceptives, estrogen, and~     progesterone. In addition, there will be questionnaires on personality and temperamental~     traits, that is, behavior and impulsiveness. Questions will also involve social intuition,~     family and other environmental factors, general functioning, and basic demographics such as~     ethnicity, race, socioeconomic status, marital status, education level, and employment~     history.~      Families enrolled in this phase of the research will be invited to participate in the next~     phase. There would be follow-up to evaluate the development of mood disorders, subtypes, and~     syndromes across the lifespan.~   "
266921|NCT00071760|"~     This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral~     activity of an investigational regimen including FDA approved HIV drugs in HIV-infected~     pediatric subjects, ages 4 weeks to < 2 years old.~   "
266922|NCT00071747|"~     The objective of this study is to evaluate the effectiveness of a marketed drug in the~     treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period.~     Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and~     who fulfill the screening entrance criteria will have an assessment 1-7 days after the first~     visit to confirm eligibility.~   "
266923|NCT00071721|"~     The purpose of this trial is to demonstrate whether valproate therapy delays the emergence of~     agitation and/or psychosis in outpatients with probable Alzheimer's disease (AD) who have not~     experienced agitation and psychosis in their illness. A secondary aim is to determine whether~     valproate therapy delays the progression of cognitive and functional measures of the illness.~     This trial will also assess the tolerability and safety of low-dose, long-term valproate~     therapy. Valproate, an anticonvulsant drug, was selected because of its possible symptomatic~     efficacy for agitation in AD, known safety profile in numerous clinical populations, and in~     view of recent data supporting its neuroprotective potential in AD.~   "
266924|NCT00071708|"~     The primary objective of this study is to provide duloxetine to investigators for the~     treatment of patients who have previously participated in neuroscience duloxetine clinical~     trials and for whom effective alternative therapy is not available.~   "
266925|NCT00071695|"~     How duloxetine compares to a medication currently available for the treatment of patients~     diagnosed with depression~   "
266926|NCT00071682|"~     The purpose of this study is to determine if the use of herbal products interferes with~     normal anticoagulation, leading to either excessive thinning of the blood and bleeding~     problems or inadequate thinning of the blood and clotting problems. Many patients who are on~     long term anticoagulation, or blood thinning, for a variety of medical problems, also take~     herbal products. It is not yet known whether use of herbal products interferes with this~     anticoagulation, and puts patients at risk for bleeding or clotting. This study will~     carefully monitor patients who are taking herbs and anticoagulants to determine if their~     laboratory tests show signs of being affected by the herbs. The study will ask all patients~     about their herbal product use, so all reported herbs will be included and monitored.~   "
266927|NCT00071669|"~     The purpose of this study is to evaluate the effectiveness of acupuncture in the treatment of~     Bipolar Depression.~   "
266928|NCT00071656|"~     The purpose of this study is to develop and implement a treatment that focuses on behaviors~     to reduce symptom severity and functional impairment in patients with Attention Deficit~     Hyperactivity Disorder, Predominantly Inattentive Type (ADHD-I). The long-term goal of this~     study is to apply the treatment to larger-scale trials to determine its effectiveness and~     generalizability.~   "
266929|NCT00071643|"~     This study will evaluate the effectiveness of both drug and non-drug treatments in preventing~     depression after a stroke.~   "
266930|NCT00071630|"~     The purpose of this study is to examine the relationship between different aspects of~     cognitive behavior therapy (CBT) and treatment outcome.~   "
266931|NCT00071617|"~     This study will attempt to improve treatment adherence and reduce suicide risk among~     adolescents who are at risk for attempting suicide.~   "
266932|NCT00071604|"~     This study will determine whether Medication Adherence Therapy (MAT) can improve medication~     adherence and lower the risk of rehospitalization in older patients with psychosis.~   "
266933|NCT00071591|"~     This study will evaluate the effectiveness of a rehabilitation program called Functional~     Adaptation Skills Training (FAST) in treating older patients with schizophrenia.~   "
266934|NCT00071578|"~     This study will compare two different approaches for the treatment for Binge Eating Disorder.~   "
266935|NCT00071734|"~     This study will examine the central regions and brain activation patterns associated with~     simple vocal behaviors under conditions of normal auditory feedback-when people hear~     themselves speak. Such feedback plays a major role in learning and maintaining human voice~     control. But voice control can be harmed by neurological injury or disease, reducing the~     ability of a person to orally communicate. Research has shown that auditory feedback is~     continuously monitored, brought about by both automatic and voluntary corrections in the~     amplitude (loudness) and frequency of (pitch) of the human voice. This study aims to~     determine which areas of the brain have activity dependent on the level of blood oxygen. It~     will provide new knowledge about basic vocal motor control and provide a basis for~     investigations into the integration of hearing and speaking in human vocal expression~     throughout life.~      Participants 18 to 45 years of age with normal hearing and voice function and with a steady~     heart rate may be eligible for this study.~      Participants will be evaluated by a speech-language specialist, regarding a history of voice~     health and measures of voice function. They will be tested on their ability to vary voice~     amplitude and frequency and tested on their hearing. Also, they will undergo an~     electrocardiogram to determine their heart rate.~      For the study, participants will undergo an MRI scan. During the MRI scan, patients will lie~     still on a table that can slide in and out of a metal cylinder surrounded by a strong~     magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans between 45~     and 90 minutes. Patients may be asked to lie still for up to 90 minutes at a time. As the~     scanner takes pictures, there will be loud knocking noises, and patients will wear headphones~     to muffle the sound. The headphones will also enable patients to hear their voice. The~     patient's head will be positioned with a coil of 25 to 30 cm diameter and supported by a~     headrest. A microphone will be placed about 2 cm from the patient's mouth for communication~     and collection of data. Also, an angled mirror will be attached to the head coil, so that the~     patient can look outside of the scanner. By way of a projection screen, the patient will~     receive a visual cue to vocalize, or use his or her voice.~      Patients will be asked to repeatedly do some of the following vocalization tasks: (1) rest,~     (2) hum or sigh without voicing (exhale), (3) hum or sigh audibly, (4) hum audibly while~     increasing or decreasing voice frequency, and (5) hum audibly while increasing or decreasing~     voice amplitude. During the scan, patients will be able to communicate with the MRI staff at~     all times and may ask to be moved out of the machine at any time. Some scans may be done in a~     3 Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the~     more common 1.5 Tesla scanner. Functional MRI is done while a person is performing tasks,~     such as moving a limb or speaking. The fMRI scan will take about 1 hour.~   "
266936|NCT00071565|"~     The purposes of this study are to identify possible genes that may increase the risk of~     aneurysm development in the brain, and to determine the effect of environmental factors such~     as cigarette smoking and high blood pressure on the expression of these genes.~   "
266937|NCT00071552|"~     The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate~     HFA on small airways compared to Fluticasone propionate powder for inhalation administered~     twice daily to poorly controlled asthmatics.~   "
266938|NCT00071539|"~     Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin~     therapy may be effective in treating malignant glioma.~   "
266939|NCT00004074|"~     Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a~     person's white blood cells to kill cancer cells. Monoclonal antibodies such as trastuzumab~     can locate tumor cells and either kill them or deliver tumor-killing substances to them~     without harming normal cells. Phase I trial to study the effectiveness of interleukin-12 and~     trastuzumab in treating patients who have cancer that has high levels of HER2/neu and has not~     responded to previous therapy~   "
266940|NCT00004050|"~     RATIONALE: Inserting the gene for interleukin-2 into a person's cancer cells may improve the~     body's ability to fight cancer. Using Leuvectin to deliver this gene may be an effective~     treatment for prostate cancer.~      PURPOSE: Phase II trial to study the effectiveness of Leuvectin followed by surgery in~     treating patients who have stage II or stage III prostate cancer.~   "
266941|NCT00004025|"~     RATIONALE: Vaccines made from a person's white blood cells combined with melanoma antigens~     may make the body build an immune response to tumor cells. Interleukin-2 may stimulate a~     person's white blood cells to kill melanoma cells. Combining vaccine therapy with~     interleukin-2 may be an effective treatment for stage III or stage IV melanoma.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without~     interleukin-2 in treating patients who have stage III or stage IV melanoma that cannot be~     surgically removed.~   "
266942|NCT00003794|"~     RATIONALE: Quality-of-life assessment of patients undergoing cancer treatment may help~     determine the intermediate- and long-term effects of treatment in patients with cancer.~      PURPOSE: This clinical trial studies the quality of life in patients with previously treated~     ovarian cancer.~   "
266943|NCT00003648|"~     RATIONALE: Determination of genetic markers for colorectal cancer may help doctors to~     identify patients who are at risk.~      PURPOSE: Genetic testing study of patients and families with a history of colorectal cancer~     to identify patients who are at risk of developing colorectal cancer.~   "
266944|NCT00071526|"~     Several studies have reported that diabetic subjects have lower plasma vitamin C~     concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic~     subjects was reported to be increased in two studies, these are difficult to interpret due to~     lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or~     methodology uncertainties in vitamin C assay and sample processing. Consequently, it is~     unclear whether diabetic subjects truly have both low plasma and high urine vitamin C~     concentrations. We propose that low plasma vitamin C concentrations in diabetic subjects are~     due in part to inappropriate renal loss of vitamin C in these subjects but not in healthy~     controls. We will study vitamin C concentrations in patients with type 1 and type 2 diabetes~     and in matched healthy research subjects. Vitamin C concentrations in plasma, neutrophils (as~     a proxy for tissue concentrations) and in urine will be measured in outpatients. In those~     willing to be admitted to the Clinical Center, we will measure 24-hour urinary excretion of~     vitamin C while on a vitamin C free diet, and creatinine clearance, a measure of glomerular~     filtration rate. On day 2 of the inpatient study, subjects will receive a single 200mg dose~     of oral vitamin C and we will measure vitamin C concentrations in frequent blood and urine~     samples to determine the renal threshold and relative bioavailability for vitamin C. Single~     nucleotide polymorphisms (SNPs) will be determined in genomic DNA responsible for the two~     proteins mediating sodium-dependent vitamin C transport, SVCT1 and SVCT2. If low plasma and~     high urine vitamin C concentrations are found in diabetic subjects, further studies will be~     needed to explore mechanisms and to determine recommended dietary allowances for this patient~     population.~   "
266945|NCT00071513|"~     This study will implement a school-based program to prevent depression, academic failure, and~     substance use in at-risk adolescents transitioning from middle school to high school.~   "
266946|NCT00071500|"~     Anti-HIV drug regimens can be very complicated. This study will evaluate a new electronic~     pillbox designed to help people take their anti-HIV drugs correctly.~   "
266947|NCT00071487|"~     The purpose of this study is to evaluate the safety and efficacy of 3 different doses of~     belimumab, administered in addition to standard therapy, in patients with active SLE disease.~   "
266948|NCT00003595|"~     Randomized phase III trial to compare the effectiveness of combination chemotherapy with or~     without monoclonal antibody therapy in treating patients who have previously untreated~     HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop~     cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as~     rituximab can locate cancer cells and either kill them or deliver cancer-killing substances~     to them without harming normal cells. It is not yet known whether combination chemotherapy~     plus monoclonal antibody therapy is more effective than combination chemotherapy alone in~     treating HIV-associated non-Hodgkin's lymphoma.~   "
266949|NCT00003266|"~     RATIONALE: Methylphenidate may relieve some of the side effects of chemotherapy in patients~     with melanoma. It is not known whether receiving methylphenidate is more effective than~     receiving no further therapy in treating patients with melanoma.~      PURPOSE: Randomized phase III trial to determine if methylphenidate is more effective than no~     further therapy for the relief of fatigue and drowsiness in treating patients with melanoma~     who have received high-dose interferon alfa for 8-24 weeks.~   "
266950|NCT00003234|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with~     recurrent or refractory cancer.~   "
266951|NCT00003190|"~     Randomized phase III trial to compare the effectiveness of combination chemotherapy with or~     without PSC 833 followed by interleukin-2 or no further therapy in treating older patients~     who have acute myeloid leukemia. Some cancers become resistant to chemotherapy drugs.~     Combining PSC 833 with more than one chemotherapy drug may reduce resistance to the drugs and~     allow the cancer cells to be killed. Combining interleukin-2 with combination chemotherapy~     plus PSC 833 may kill more cancer cells.~   "
266952|NCT00003126|"~     The purpose of this study is to assess the efficacy of post-operative high-dose bolus~     interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).~   "
266953|NCT00071474|"~     This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing~     for treating temporomandibular joint disorders (TMDs).~   "
271145|NCT00037310|"~     To explore the associations between cognitive functioning and three major cardiovascular~     disease risk factors: high blood pressure; high total plasma homocysteine (tHcy); and ApoE e4~     genotype.~   "
266954|NCT00071461|"~     Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including~     pulmonary vascular disease and pulmonary fibrosis.~      Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic~     pulmonary fibrosis (IPF), a condition for which no established treatment is available.~      The present trial investigates a possible use of bosentan, which is currently approved for~     the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a~     new category of patients suffering from IPF.~      It was decided to offer Open Label treatment (bosentan) for patients willing to continue in~     the BUILD 1 study.~   "
266955|NCT00071448|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to to~     determine whether insulin aspart can be used effectively and safely in paediatric patients.~   "
266956|NCT00071435|"~     This study will examine whether the motor cortex (the part of the brain that controls~     movement) works properly in patients with primary lateral sclerosis (PLS), a disorder in~     which voluntary movements are very slow.~      Healthy volunteers between 40 and 75 years of age and patients with ascending PLS (a subset~     of PLS) may be eligible for this study. Patients with ascending PLS have a slowing of~     finger-tapping movements that corresponds to a particular abnormality of certain neuronal~     (nerve cell) activity.~      Participants perform a finger-tapping reaction time exercise while brain wave activity~     (electroencephalography, or EEG) and muscle activity (electroymogram, or EMG) are measured.~     The subject is seated in front of a computer screen. A signal appears on the screen and the~     subject taps a key as quickly as possible in response to the signal.~      For the EEG, brain activity is recorded by placing electrodes (small metal discs) on the~     scalp with an electrode cap or glue-like substance. A conductive gel is used to fill the~     space between the electrodes and the scalp to make sure there is good contact between them.~     The brain waves are recorded while the subject taps his or her fingers very slowly. For the~     surface EMG, electrodes filled with a conductive gel are taped to the skin.~      Participants also undergo magnetic resonance imaging (MRI). This test uses a strong magnetic~     field and radio waves to obtain images of the brain. During the procedure, the subject lies~     still on a table that can slide in and out of the scanner - a narrow metal cylinder. Scanning~     time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes.~     Subjects can communicate with the MRI staff at all times during the scan and can ask to be~     moved out of the machine at any time.~   "
266957|NCT00071422|"~     Insulin is a chemical that the body needs in order to use or store sugar. It is made by a~     type of cell called a beta cell which resides in an organ known as the pancreas. Type 2~     diabetes is a disease where the beta cells are unable to meet a person's insulin needs. Sugar~     levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new~     beta cells in the pancreas, and to improve the ability to produce insulin in type 2 diabetic~     patients.~   "
266958|NCT00071409|"~     Insulin is a chemical that the body needs in order to use or store sugar. It is made by a~     type of cell called a beta cell which resides in an organ known as the pancreas. Type 1~     diabetes is a disease where the beta cells have been destroyed so that little or no insulin~     is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt~     to create new beta cells in the pancreas, and to restore the ability to produce insulin in~     type 1 diabetic patients.~   "
266959|NCT00071396|"~     The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can~     shrink or slow the growth of the disease in patients with chronic lymphoid disorders that~     have either not responded or whose disease has returned after treatment with standard~     therapies.~   "
266960|NCT00033527|"~     RATIONALE: INS316 may produce a better sputum sample for laboratory analysis and may provide~     a less invasive method of diagnosing lung cancer.~      PURPOSE: Randomized diagnostic trial to compare the effectiveness of INS316 with that of~     saline for sputum collection in diagnosing lung cancer in patients suspected of having lung~     cancer.~   "
266961|NCT00025350|"~     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor~     cells and slow the growth of recurrent metastatic colorectal cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of~     gefitinib in treating patients who have recurrent metastatic colorectal cancer.~   "
266962|NCT00003077|"~     RATIONALE: Omega-3 fatty acids are used by the body for energy and tissue development and may~     be an effective treatment for patients with advanced cancer who are unable to maintain their~     body weight.~      PURPOSE: Phase I/II trial to study the effectiveness of omega-3 fatty acids in treating~     patients with advanced cancer who have significant weight loss.~   "
266963|NCT00002935|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill tumor cells. This may be an effective treatment for esophageal cancer.~      PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy in treating~     patients with Barrett's esophagus who have in situ esophageal cancer.~   "
266964|NCT00002723|"~     Randomized phase III trial to compare the effectiveness of low, intermediate, and high dose~     suramin in treating men with stage IV prostate cancer that is refractory to hormone therapy.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. It is not yet known which regimen of suramin is more effective for prostate~     cancer.~   "
266965|NCT00071331|"~     The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults~     with worsening congestive heart failure (CHF).~   "
266966|NCT00071292|"~     The purpose of this study is to determine whether a mindfulness meditation-based stress~     reduction program is useful in relieving symptoms associated with rheumatoid arthritis (RA).~   "
266967|NCT00030420|"~     RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining chemotherapy with celecoxib may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in~     treating patients who have advanced non-small cell lung cancer that has been previously~     treated with platinum-based chemotherapy.~   "
266968|NCT00026260|"~     RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical~     cancer by stopping blood flow to the tumor.~      PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have~     persistent or recurrent cervical cancer.~   "
266970|NCT00024128|"~     RATIONALE: Donor peripheral stem cell transplantation may be able to replace immune cells~     that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells~     are rejected by the body's normal tissues. Treatment with donor white blood cells may prevent~     this from happening.~      PURPOSE: Phase II trial to study the effectiveness of donor peripheral stem cell~     transplantation followed by infusions of donor white blood cells in treating patients who~     have AIDS-related lymphoma.~   "
266971|NCT00023738|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Drugs such as SU5416 may stop the growth of cancer by stopping~     blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Giving chemotherapy, SU5416, and radiation therapy before and after surgery may kill more~     tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy, SU5416, radiation~     therapy, and surgery in treating patients who have soft tissue sarcoma.~   "
266972|NCT00071370|"~     This study will evaluate how the state of being completely deprived of sleep has an effect on~     recordings of magnetoencephalography (MEG) and electroencephalography (EEG), in relation to~     how alert someone is and how sleepy someone perceives himself or herself to be. EEG measures~     electronic potential differences on the scalp. On the other hand, MEG is a non-invasive~     technique for recording the activity of neurons in the brain, through recording of magnetic~     fields caused by synchronized neural currents. It has the ability to detect seizures. Because~     magnetic signals of the brain vary, this technique must balance two key problems: weakness of~     the signal and strength of the noise. The EEG is sensitive to extra-cellular volume currents,~     whereas the MEG primarily registers intra-cellular currents. Because electrical fields are~     quite dependent on the conductive properties of the tissues, and magnetic fields are~     significantly less distorted by tissue, the MEG has better spatial resolution. There is a~     great deal of evidence that EEG and MEG provide complementary data about underlying currents~     of ions.~      The complex relationship of sleep and epilepsy is well known. Sleep has been used for many~     years as a powerful EEG activator. Many researchers have supported the hypothesis that there~     is a specific activating effect of sleep deprivation on epileptic discharges. Sleep~     deprivation is defined as a sleepless state of longer than 24 hours. The increased use of MEG~     in diagnosis could improve the procedure for evaluating patients before surgery for epilepsy,~     by making invasive studies less necessary.~      Patients 18 years of age or older, with a diagnosis of epilepsy and with a documented last~     routine EEG (at least 2 weeks earlier) and routine EEG on the day of a baseline MEG-EEG~     without interictal epileptiform discharges (IEDs) may be eligible for this study.~      Participants will be rated according to the Epworth, Stanford, and Karolinska Sleepiness~     Scales, to determine their subjective sleepiness. They will be randomly assigned to stay~     awake all night or sleep in the hospital overnight. That is, a sleep deprivation and~     non-sleep deprivation synchronized MEG-EEG recording will be performed in random order. Then~     the sequence of sleep deprivation and non-sleep deprivation will be reversed within 14 to 21~     days. During the recordings, the patient will either sit or lie with his or her head in a~     helmet covering the entire head, with openings for the eyes and ears. Brain magnetic fields~     will be recorded with a 275-channel OMEGA system. Throughout the session, visual and two-way~     audio communication will be maintained with the patient. Recording sessions will last 90 to~     180 minutes, with the patient allowed to take breaks after at least 10 minutes in a scanner.~     Attempts will be made to encourage patients to stay awake and sleep for about the same amount~     of time during each recording, to acquire comparable amounts of sleep and awake recordings.~   "
266973|NCT00071305|"~     This study will evaluate the magnetoencephalography (MEG) alone and together with~     electroencephalography (EEG) in non-invasive presurgical evaluation. It will look at the~     contribution of those methods in determining the location of the epilepsy seizure, compared~     with doing so through an invasive method. EEG measures electronic potential differences on~     the scalp. On the other hand, MEG is a non-invasive technique for recording the activity of~     neurons in the brain, through recording of magnetic fields caused by synchronized neural~     currents. It has the ability to detect seizures. Because magnetic signals of the brain vary,~     this technique must balance two key problems: weakness of the signal and strength of the~     noise. The EEG is sensitive to extra-cellular volume currents, whereas the MEG primarily~     registers intra-cellular currents. Because electrical fields are quite dependent on the~     conductive properties of the tissues, and magnetic fields are significantly less distorted by~     tissue, the MEG has better spatial resolution. There is a great deal of evidence that EEG and~     MEG provide complementary data about underlying currents of ions.~      Patients 18 years of age or older who have epilepsy that is not relieved, and who are~     considered candidates for surgery and who accept epilepsy surgery, may be eligible for this~     study.~      Before they have surgery, participants will either sit or lie down, with their head in a~     helmet covering the entire head, with openings for the eyes and ears. Brain magnetic fields~     will be recorded with a 275-channel OMEGA system. Throughout the session, visual and two-way~     audio communication will be maintained with the patient. Acquiring data from the participant~     will be conducted during several sessions, each lasting from 10 to 60 minutes, not exceeding~     a total of 120 minutes. If the first recording is not of sufficient quality, the patient may~     have it repeated once or twice.~      Those participants who are found to have a clear seizure focus will proceed directly to~     surgery that is part of their treatment. Those whose seizure focus is ambiguous will proceed~     to invasive monitoring.~      Participants will be followed in the outpatient clinic at intervals of 1, 3, 6, and 12~     months. They may periodically undergo reimaging as considered appropriate.~   "
266974|NCT00071279|"~     Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis~     (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant~     (blood-thinning) drugs are normally given immediately after the clot is discovered and are~     continued for a period of 3 or 6 months during which time the risk for recurrence is highest.~     Research has shown that when oral anticoagulants are used appropriately during this period,~     patients are less at risk for a recurrent blood clot and this risk reduction outweighs the~     potential for bleeding to occur.~      In this study, patients who had a blood clot in the lung or in a leg vein and completed 6~     months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or~     once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6~     months of once-weekly SR34006 injections or injections of a solution containing no drug~     (placebo). This trial will evaluate whether patients treated for an additional 6 months with~     SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.~      Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor~     their doctors will know which treatment is being given.~   "
266975|NCT00071266|"~     The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin,~     Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of~     their leg arteries.~      At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take~     part in this study.~      Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug~     Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a~     combination of these two drugs, is also approved by the FDA to treat high cholesterol. The~     use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve “intermittent~     claudication” (leg pain caused by narrowing of the arteries in the leg) is considered~     investigational. An investigational use is one that is not approved by the FDA.~   "
266976|NCT00071253|"~     The purpose of this study is to assess the efficacy and safety of continued combination~     therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy~     in stable subjects during the maintenance phase of bipolar illness.~   "
266977|NCT00071240|"~     Growth hormone plays an important role in the development of the immune system. Studies~     suggest that growth hormone may promote growth of the thymus, a gland responsible for the~     production of important immune cells called T cells. Since these cells are lost during the~     course of HIV infection, it is possible that growth hormone treatment could help restore the~     immune system. This study will determine whether the administration of growth hormone can~     increase the size and function of the thymus and cause an increase in the number of new T~     cells in the blood of people infected with HIV.~      Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected~     adults.~   "
266978|NCT00071214|"~     Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic~     hemodialysis patients against infection by Staphylococcus aureus.~   "
266979|NCT00071201|"~     This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the~     efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients~     with chronic hepatitis B and varying degrees of renal impairment.~   "
266980|NCT00064428|"~     This is a randomized, double blindcontrolled, parallel group, multi-center, multinational~     study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction)~     randomized within 24 hours of the onset of symptoms.~   "
266981|NCT00071227|"~     This study will evaluate the safety and effectiveness of a new formulation of triamcinolone~     acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid~     drug that decreases inflammation and scarring and is routinely used to treat eye inflammation~     or swelling. The commercially available form of this drug is associated with potentially~     harmful side effects thought to be due to preservatives in the preparation. This study will~     use a formulation that does not contain these potentially harmful preservatives. Preliminary~     findings from other studies suggest that injection of steroids in the eye can reduce retinal~     thickening and improve vision. However, they may also cause mild discomfort and lead to~     vision-threatening conditions. The effects of the drug on the conditions under study in this~     protocol are not known.~      Patients with the following conditions involving disorders of retinal blood vessels may be~     eligible for this study:~        -  Choroidal neovascularization associated with age-related macular degeneration (50 years~          of age and older)~        -  Macular edema associated with retinal vein occlusion (18 years of age and older)~        -  Diabetic macular edema ((18 years of age and older)~      Participants undergo the following tests and procedures:~        -  Medical history and physical examination~        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to~          examine pupils, lens, retina and eye movements. The pupils will be dilated with drops~          for this examination.~        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected~          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina~          are taken using a camera that flashes a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating possible blood vessel~          abnormality.~        -  Indocyanine green angiography to identify feeder vessels that may be supplying abnormal~          blood vessels. This procedure is similar to fluorescein angiography, but uses a green~          dye and flashes an invisible light.~        -  Optical coherence tomography to measure retinal thickness. This test shines a light into~          the eye and produces cross-sectional pictures of the retina. These measurements are~          repeated during the study to determine if retinal thickening is getting better or worse,~          or staying the same.~        -  Stereoscopic color fundus photography to examine the back of the eye. The pupils are~          dilated with eye drops to allow examination and photography of the back of the eye.~        -  Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic~          eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide~          is injected into the eye's vitreous (jelly-like substance inside the eye). After the~          injection, the patient lies on his or her back for 30 minutes. An antibiotic eye~          ointment is used for 2 days following treatment.~        -  Blood tests to measure liver and kidney function.~      Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the~     first treatment. Patients whose condition does not improve after 3 months do not receive any~     more injections, but return for eye examinations at least once a year for 3 years. Patients~     whose condition improves with treatment return for follow-up visits 6 and 9 months after the~     first injection and then every 6 months for 2 more years. At each visit, a determination is~     made whether another injection is needed. After each repeat injection, patients return for~     follow-up visits at 1, 4, and 7 days after the injection.~   "
267014|NCT00070902|"~     Lumbar spinal manipulation, or chiropractic adjusting, is thought to separate the surfaces of~     the spinal joints and thereby relieve lower back pain. This study will use MRI scans to~     evaluate the spinal joints before and after spinal manipulation.~   "
267015|NCT00070889|"~     Patients experiencing a first episode of psychosis may have brain cell damage due to a~     chemical process called oxidation. This study will compare patients with psychosis to healthy~     volunteers to determine if there are differences in their blood that reflect oxidative brain~     cell damage.~   "
266982|NCT00071188|"~     The purpose of the run-in phase of this study is to determine the appropriate and tolerable~     dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and~     carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This~     phase of the trial is closed to enrollment.~      The purpose of the randomized phase of this study is to determine the efficacy of ZD6474~     alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of~     paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or~     metastatic NSCLC. This phase of the trial is closed to enrollment.~   "
266983|NCT00071136|"~     This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days~     to patients with advanced stage non-small cell lung cancer. This treatment is for patients~     that have not received any prior chemotherapy treatment for lung cancer. The primary goal is~     to find out if the tumor gets smaller or disappears with this treatment.~   "
266984|NCT00071175|"~     The Lupus Genetics Studies and Lupus Family Registry & Repository are working to find the~     genes that reveal the causes of systemic lupus erythematosus (SLE, or lupus). The study is~     enrolling families of all ethnic backgrounds from the United States, Canada, Puerto Rico, and~     the Virgin Islands that have one or more living members diagnosed with SLE.~   "
266985|NCT00071162|"~     The Fibromyalgia Family Study identifies and collects blood samples from families with two or~     more members affected with Fibromyalgia Syndrome (FMS). The primary goal of the study is to~     identify genes that predispose people to FMS and/or symptoms related to FMS; identifying~     these genes may lead to a better understanding of the disease and more effective treatments.~   "
266986|NCT00071149|"~     Practitioners of Traditional Chinese Medicine (TCM) make diagnoses based solely on clinical~     symptoms. This study will evaluate whether TCM practitioners make diagnoses consistently.~   "
266987|NCT00071110|"~     This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and~     sham electroacupuncture (SA) for the treatment of major depression.~   "
266988|NCT00071097|"~     The purpose of this study is to determine the effectiveness, safety, and tolerability (how~     well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114~     given with low dose ritonavir.~   "
266989|NCT00071084|"~     The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for~     advanced stage (late stage) cutaneous T-cell lymphoma (CTCL). Almost all patients who are~     affected by late stage CTCL have many cancerous cells which bear a receptor called CD4.~     HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in~     this trial; all patients will be treated with HuMax-CD4. The response rates, duration of~     responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated during this~     trial.~   "
266990|NCT00071071|"~     The purpose of this trial is to determine the effect of HuMax-CD4 as a treatment for early~     stage cutaneous T-cell lymphoma (CTCL). Almost all patients who are affected by CTCL have~     cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug~     directed against this receptor. There is no placebo in this trial; all patients will be~     treated with HuMax-CD4. During the trial, the response rates, duration of responses, relief~     of symptoms, and safety profile of HuMax-CD4 will be evaluated.~   "
266991|NCT00025467|"~     Phase II trial to study the effectiveness of thalidomide in treating patients who have~     recurrent or persistent endometrial cancer. Thalidomide may stop the growth of cancer by~     stopping blood flow to the tumor~   "
266992|NCT00023725|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     SU5416 may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known~     if radiation therapy is more effective with or without SU5416 in treating soft tissue~     sarcoma.~      PURPOSE: Phase I/II trial to compare the effectiveness of radiation therapy with or without~     SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma.~   "
266993|NCT00023699|"~     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor~     cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer.~      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have~     recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.~   "
266994|NCT00022282|"~     RATIONALE: AE-941 may help to slow the growth of multiple myeloma.~      PURPOSE: Phase II trial to study the effectiveness of neovastat in treating patients who have~     relapsed or refractory multiple myeloma.~   "
266995|NCT00016250|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of~     Ro 31-7453 in treating patients who have recurrent or refractory metastatic colorectal~     cancer.~   "
266996|NCT00015912|"~     Phase II trial to study the effectiveness of combining thalidomide with interferon alfa in~     treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Thalidomide may~     stop the growth of cancer by stopping blood flow to the tumor. Interferon alfa may interfere~     with the growth of cancer cells. Combining thalidomide with interferon alfa may kill more~     tumor cells~   "
266997|NCT00015886|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     women who have breast cancer that is metastatic or cannot be treated with surgery.~   "
266998|NCT00014144|"~     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor~     cells and slow the growth of cancer of the urinary tract.~      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have~     advanced cancer of the urinary tract.~   "
266999|NCT00007917|"~     Phase I trial to study the effectiveness of gemcitabine plus flavopiridol in treating~     patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may~     kill more tumor cells.~   "
267016|NCT00070850|"~     Smith-Lemli-Opitz Syndrome (SLOS) is a genetic condition that causes mental retardation and~     other birth defects. This study will evaluate a new prenatal screening test for SLOS.~   "
267000|NCT00071383|"~     This study will examine two subsets of patients with breast cancer metastasis, that is,~     spreading, to the brain. It will identify genes and proteins that promote metastasis,~     particularly in women who are found to over-express (have more than other people do) the~     human epidermal growth factor receptor, ErbB2, also known as HER-2. The molecular and genetic~     events that permit tumor metastasis are not well understood. There is intense investigation~     going on into the process in which tumor cells escape the primary local tumor, spread to~     distant places in the body, and find and create conditions that promote growth in those~     tissues. Metastasis of tumors such as breast cancer to the brain is a common problem. Tumor~     cells will be analyzed with the use of microarrays. A microarray is a tool for analyzing gene~     expression, consisting of a small membrane or glass slide containing samples of many genes~     arranged in a regular pattern. The goal is to identify a potential molecular signature. It is~     hoped that there will be discovery of why some patients are more likely than others to~     develop a brain metastasis, which can have a major negative effect on the quality of life and~     survival.~      Female patients 18 years of age with known or evidence by radiology of a breast tumor~     metastatic to the brain or those who have had a removal of a brain tumor for diagnosis or~     treatment may be eligible for this study.~      Participants will undergo the following procedures and tests:~        -  Craniotomy, that is, surgical opening of the skull, and removal of the brain tumor.~        -  Blood specimens taken from a central vein or artery before the operation, throughout as~          needed, and for several days afterward, to measure blood chemistries, blood count, and~          so forth.~        -  Physical examination and imaging of the central nervous system before and after surgery.~        -  Urine or serum, or both, pregnancy test of women of childbearing potential.~      Patients will also undergo blood tests at 3-month intervals after surgery for up to 5 years.~     The purpose is to determine if there are tumor cells in the blood, which may explain how they~     reached the brain.~   "
267001|NCT00071357|"~     This study will examine a non-invasive method to assess vasculature, that is, the development~     of a blood supply necessary to the growth of tumors. The hope is to identify the way that~     genes are expressed within the tumor itself, from areas shown as low flow versus those shown~     as high flow on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).~      Most patients with solid epithelial cancers, those that develop on free surfaces or linings~     inside the body, die because of the distant spread of tumors-metastasis. After that spread, a~     cure is more difficult than if the tumors were detected early or locally. Tumors develop a~     new supply of blood. Traditional anticancer therapies have had the goal of causing a decline~     in the tumor. Yet by focusing on the tumor's blood supply, microscopic differences between~     tumors and clonal differences within tumors may be avoided. Doing so may overcome tumor~     resistance to treatment and may result in treatments that can be more universally applied~     across tumor types.~      Female patients 18 years of age enrolled in the protocol Analysis of Brain Metastasis in~     Patients with Breast Cancer, with and without Over-Expression of HER-2, who will undergo an~     MRI scan immediately before surgery will be invited to participate in this study. Patients~     seen in the oncology outpatient clinic of the NIH Clinical Center or by referral from outside~     physicians may be eligible for this study.~      Participants will undergo DCE-MRI immediately before the craniotomy-the surgery scheduled-in~     conjunction with other clinically indicated MRI. The preoperative MRI will take about 30~     minutes, and the DCE-MRI will take no more than 15 minutes. During the MRI, patients will lie~     still on a table that can slide in and out of a metal cylinder surrounded by a strong~     magnetic field. They may be asked to lie still for up to 5 minutes at a time. As the scanner~     takes pictures, there will be loud knocking noises, and the patients will wear earplugs to~     muffle the sound. Patients will be able to communicate with the MRI staff at all times during~     the scan and may ask to be moved out of the machine at any time. During part of the MRI,~     patients will receive a contrast agent, one that is gadolinium-based, into a vein. This agent~     changes the relative brightness or contrast on the MRI image under some conditions. Before~     that agent is used, patients will be asked about any previous allergic reactions to~     gadolinium-based contrast agents.~   "
267002|NCT00071344|"~     This study will examine patients with non-small cell lung cancer metastasis, that is, the~     distant spreading of tumors to the brain, and compare them with patients without brain~     metastasis. The molecular and genetic events that permit tumor metastasis are not well~     understood. There is intense investigation going on into the process in which tumor cells~     escape the primary local tumor, spread to distant places in the body, and find and create~     conditions that promote growth in those tissues. Metastasis of tumors such as lung cancer to~     the brain is a common problem. Tumor cells will be analyzed with the use of microarrays. A~     microarray is a tool for analyzing gene expression, consisting of a small membrane or glass~     slide containing samples of many genes arranged in a regular pattern. The goal is to identify~     a potential molecular signature. It is hoped that there will be discovery of why some~     patients are more likely than others to develop a brain metastasis, which can have a major~     negative effect on the quality of life and survival.~      Patients 18 years of age with known or evidence by radiology of a non-small cell lung cancer~     metastatic to the brain, either squamous cells or adenocarcinoma tumors, or those who have~     had a removal of a brain tumor for diagnosis or treatment may be eligible for this study.~      Participants will undergo the following procedures and tests:~        -  Craniotomy, that is, surgical opening of the skull, and removal of the brain tumor.~        -  Blood specimens taken from a central vein or artery before the operation, throughout as~          needed, and for several days afterward, to measure blood chemistries, blood count, and~          so forth.~        -  Physical examination and imaging of the central nervous system before and after surgery.~        -  Urine or serum, or both, pregnancy test of women of childbearing potential.~      Patients will also undergo blood tests at 3-month intervals after surgery for up to 5 years.~     The purpose is to determine if there are tumor cells in the blood, which may explain how they~     reached the brain.~   "
267003|NCT00071123|"~     This study will evaluate emotional processing biases in the brain while viewing facial~     expressions in adults with current or remitted major depressive disorder and healthy~     volunteers.~   "
267004|NCT00071032|"~     The purpose of this study is to compare liberal red blood cell transfusion therapy with~     restrictive red blood cell transfusion therapy in surgical patients with cardiovascular~     disease or risk factors.~   "
267005|NCT00071019|"~     To examine the relationship between genetic and dietary factors that modify the risk of~     coronary heart disease (CHD).~   "
267006|NCT00071006|"~     The study tests the safety and efficacy of axitinib in patients who have the hematologic~     disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who~     have poor prognosis before entering the study.~   "
267007|NCT00070993|"~     Creatine is a naturally occurring chemical involved in the production of energy in muscle.~     Abnormalities in creatine have been linked to the progression of degenerative neuromuscular~     diseases such as amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). This study~     will test whether taking creatine can improve the symptoms of ALS.~   "
267008|NCT00070980|"~     The purpose of this study is to determine whether massage therapy can improve immune status~     and enhance well-being in children living in the Dominican Republic who are infected with~     HIV.~   "
267009|NCT00070967|"~     This study will test the feasibility of acupuncture as a complementary therapy for advanced~     cancer by comparing symptoms and quality of life before and after 8 weeks of acupuncture~     treatments.~   "
267010|NCT00070954|"~     Electroconvulsive therapy (ECT) is an effective treatment for severe or medication-resistant~     depression and other psychiatric disorders. A common side effect of ECT is problems with~     short-term memory during treatment. This study will test whether taking ginkgo biloba (GB)~     prior to and during the course of ECT will lessen the effects of ECT on short-term memory.~   "
267011|NCT00070941|"~     This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of~     depression in patients with Parkinson's disease (PD).~   "
267012|NCT00070928|"~     The purpose of this trial is to test the short-term effectiveness of valerian, a medicinal~     herb, to improve sleep in patients with Parkinson's disease (PD).~   "
267013|NCT00070915|"~     This clinical trial is a preliminary study designed to prepare for a full-scale, randomized~     clinical trial of the effectiveness of tai chi, mediation, and therapeutic massage for~     chronic lower back pain in adults.~   "
267017|NCT00070837|"~     The purpose of the study is to determine the highest dose of MLN2704 that can be given~     multiple times safely to patients with prostate cancer, and to identify any side effects~     associated with taking the drug. This study will also evaluate how MLN2704 is taken up,~     broken down and eliminated by the body.~   "
267018|NCT00070824|"~     The goal of this study is to use single photon emission computed tomography (SPECT) and~     functional magnetic resonance imaging (f-MRI) of the brain to study the response of both~     normal participants and participants with Osteoarthritis (OA) of the knee to acupuncture.~   "
267019|NCT00070811|"~     The purpose of this study is to determine whether secondary (revision) surgery to the lip in~     patients with cleft lip and palate is effective in improving lip function and appearance.~   "
267020|NCT00070720|"~     Many obstetrical interventions used in Latin America, as in other parts of the world, have~     been shown to be ineffective or harmful, while effective interventions remain underutilized.~     This study will develop and evaluate an intervention intended to implement two evidence-based~     practices among birth attendants in Latin America, the selective use of episiotomies and~     active management of the third stage of labor.~   "
267021|NCT00071058|"~     This study will examine the safety and effectiveness of treating adrenocortical cancer with~     combination chemotherapy using doxorubicin, vincristine, and etoposide in addition to the~     drugs mitotane and tariquidar and, when possible, surgery. Adrenocortical cancer cells have a~     large amount of a protein called P-glycoprotein that pumps anti-cancer drugs out of the~     cells, decreasing their effectiveness. Continuous infusions of doxorubicin, vincristine, and~     etoposide may improve chemotherapy results by blocking the P-glycoprotein pump, as may use of~     tariquidar, an experimental drug that is known to block the P-glycoprotein pump.~      Patients 18 years of age and older with adrenocortical cancer that has recurred, spread, or~     cannot be treated surgically may be eligible for this study. Candidates will be screened with~     a medical history and physical examination; review of pathology slides; blood tests;~     electrocardiogram (EKG); imaging tests, including computed tomography (CT) of the chest,~     abdomen and pelvis; chest x-ray; and possibly a bone scan or other imaging tests needed to~     evaluate the cancer, urine studies, and an echocardiogram. Also, a biopsy (removal of a small~     sample of tumor tissue) may be required if a specimen is not available to confirm the cancer.~      Participants will undergo the following tests and procedures:~        -  Tumor biopsy. Before starting chemotherapy, a small piece of tumor is removed to study~          the P-glycoprotein pump and to determine the tumor genetics.~        -  Blood draw. Blood is drawn before treatment begins to establish baseline levels for~          future blood tests.~        -  Central venous catheter placement. A specially trained physician places a plastic tube~          into a major vein in the chest. The tube is used to give the study drugs and other~          medications and to withdraw blood samples. It can stay in the body for months or be~          removed after each treatment is completed. The tube placement is done under a local~          anesthetic in the radiology department or operating room.~        -  Chemotherapy. Treatment cycles are 21 days. Doxorubicin, vincristine, and etoposide are~          given through the central venous catheter by an infusion pump continuously over 96 hours~          starting day 1 of each cycle. The dose of these drugs may be increased or decreased from~          cycle to cycle, based on side effects. Mitotane is given in pill form starting day 1 of~          cycle 1 and is taken every day throughout the entire study. The mitotane dose is~          gradually increased as long as the side effects are tolerable. Tariquidar is given~          through the central venous catheter as a 30-minute infusion on days 1 and 3 of every~          cycle. The tariquidar dose remains the same throughout the study. Treatment will~          continue for two cycles after all the cancer is gone, or until surgery is done to remove~          some or all of the remaining cancer, or, if surgery is not an option, until the cancer~          has grown to where it is defined as progressive disease.~        -  Nuclear scans. A nuclear scan is done before treatment begins and again on day 1 or day~          3 of the first treatment cycle after administration of tariquidar to evaluate the P~          glycoprotein response to treatment.~        -  Computed tomography (CT) scans. These scans are done every two treatment cycles to~          follow disease progress.~        -  Surgery. Surgery to remove areas of cancer may be considered at any point during the~          study (including before beginning treatment), if it is deemed beneficial. Treatment with~          the study drugs will begin or resume after surgery. The length of treatment will depend~          on the response to treatment before the surgery and on whether there is any cancer~          remaining after the surgery.~   "
267022|NCT00071045|"~     This study will collect biological samples for use in research experiments aimed at better~     understanding the clinical features of certain diseases. The specimens may be used to~     evaluate the effectiveness of known therapies, refine treatment approaches, identify~     potential new therapies, and explore opportunities for disease prevention.~      The following individuals 2 years of age or older may be eligible for this study:~        -  Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder who~          are being screened for or who are enrolled in a treatment study at the NIH Clinical~          Center~        -  HLA-compatible donor family members (18 years of age or older) of the above patients who~          are being evaluated for or are enrolled in an NIH study as a stem cell transplant donor~        -  Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder or~          a bone marrow failure condition who cannot participate in an NIH treatment protocol or~          travel to the NIH Clinical Center and who are referred for participation through their~          home health care provider.~      Research samples will be collected from participants when blood is drawn or bone marrow,~     urine, or stool is collected, or tumor or other tissue is biopsied as part of their general~     medical care. Investigators may periodically request an additional sample of blood, stool, or~     urine. Participants who are 18 years of age or older may donate a large number of white blood~     cells through a procedure called leukapheresis. This procedure is not part of general medical~     care and would be done for research purposes only. For apheresis, a catheter (plastic tube)~     is placed in a vein in the subject's arm. Blood flows from the vein into a cell separator~     machine, where the white cells are separated from the red cells, platelets, and plasma by a~     spinning process. The white cells are removed and collected, and the rest of the blood is~     returned to the subject through a second tube placed in the other arm.~   "
267023|NCT00070746|"~     There are large differences in health outcomes related to pregnancy and birth between~     developed and developing countries. This study will investigate how infections, medical~     history, health care behavior and psychosocial issues are associated with pregnancy outcomes~     in Pakistan.~   "
267024|NCT00070733|"~     The enzyme 5-alpha reductase is present in small amounts in muscle and converts testosterone~     to dihydrotestosterone (DHT). Testosterone affects lean body tissue, muscle size, muscle~     strength, and sexual function in men. This study will evaluate how 5-alpha reductase~     influences the effects of testosterone in young healthy men.~   "
267025|NCT00070707|"~     An association between seasonal allergic rhinitis (SAR) and allergic asthma has been~     established through epidemiologic, pathophysiologic, and therapeutic studies. This study will~     compare Nasonex Nasal Spray to Placebo in treating the nasal and asthma symptoms experienced~     by subjects with SAR and concomitant asthma.~   "
267026|NCT00070876|"~     This study will provide psychosocial training to general health care providers to help them~     provide better care to children with mental health problems.~   "
267027|NCT00070863|"~     This study will develop an individual behavior therapy for men who are violent toward their~     partners and will compare the therapy to standard group treatment.~   "
267028|NCT00070681|"~     To determine the effects of sleep disorders on cardiovascular function and disease in older~     men.~   "
267029|NCT00070668|"~     To investigate the relationship between genetic variation in genes for inflammation and~     carotid artery atherosclerosis.~   "
267030|NCT00070655|"~     This trial will include patients who have a heart condition called atrial fibrillation.~     Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial~     fibrillation have an increased chance for a blood clot to form in the heart and move to other~     blood vessels in the body and cause obstruction. This obstruction may damage tissue. For~     example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore,~     patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as~     warfarin or acenocoumarol.~      The purpose of this study is to compare the safety and effectiveness of a new injectable~     anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol~     tablets.~      Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol)~     tablets will be purely by chance and will be known by both patients and their doctors.~   "
267031|NCT00069433|"~     This study will determine the effectiveness of skills training in people with schizophrenia~     and the applicability of the acquired skills in the real world.~   "
267032|NCT00021099|"~     Phase II trial to study the effectiveness of ixabepilone in treating patients who have~     progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways~     to stop tumor cells from dividing so they stop growing or die~   "
267033|NCT00017368|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Peripheral~     stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation in treating children who have newly diagnosed~     neuroblastoma.~   "
267034|NCT00003907|"~     RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and~     keeping chemotherapy drugs near the tumor.~      PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients~     who have primary liver cancer or metastases to the liver that cannot be surgically removed.~   "
267047|NCT00006009|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have advanced or recurrent lymphoma.~   "
271149|NCT00037258|"~     To determine the role of dyslipidemia, markers of endothelial dysfunction genetic~     susceptibility, and dietary fat intake on the development of cardiovascular disease (CVD)~     complications in Type II diabetes mellitus.~   "
267035|NCT00070785|"~     This study will evaluate the ability of people of different ethnic backgrounds to develop~     immune responses against the Epstein-Barr virus (EBV). A common virus, EBV is present in 90~     percent of healthy people and usually does not cause problems. Most people are infected in~     childhood, have no symptoms, and are unaware of their infection. People infected as~     adolescents or adults may develop infectious mononucleosis, which usually resolves~     completely. However, in immune suppressed people, like those who have had a transplant, EBV~     can cause fatal cancers. It can also cause certain cancers such as Burkitt's lymphoma,~     Hodgkin's lymphoma, and nasopharyngeal carcinoma in people who are not immune suppressed.~     Nasopharyngeal carcinoma is 100 times more common in people of Asian origin (particularly~     southern Chinese) compared with Caucasians. This difference may be the result of genetic,~     rather than environmental, factors. This study will examine whether the same proteins~     produced by EBV in the cancer cells react differently in people of different ethnic~     background in a way that could explain the differences in predisposition for this disease.~      Healthy normal volunteers 18 years of age and older of Caucasian or Chinese ancestry may be~     eligible for this study. Candidates of Chinese ancestry must be born in China (including~     Taiwan, Hong Kong, and Singapore, or be first generation offspring of parents born in these~     places).~      Participants will have a blood sample drawn and will undergo lymphapheresis - a procedure for~     collecting large numbers of white blood cells called lymphocytes. The blood sample is tested~     for blood counts and HLA type, a genetic marker of the immune system. HLA molecules help~     determine the way the body's immune cells respond to virus. HLA typing is similar to blood~     typing. Usually done to match stem cell or organ transplants, HLA testing may also be used to~     try to identify factors associated with an increased risk of certain diseases or conditions.~     HLA type is strongly associated with ethnic background.~      For lymphapheresis, blood is collected through a needle in an arm vein, similar to donating~     blood. The blood flows from the vein through a catheter (plastic tube) into a machine that~     separates it into its components by centrifugation (spinning). The white cells are removed~     and the rest of the blood (red cells, plasma and platelets) is returned to the body through a~     needle in the other arm. The procedure takes 2 to 3 hours. The collected white cells are used~     for research for this study, including the ability to react to EBV proteins, and are then~     destroyed.~   "
267036|NCT00070759|"~     This study will examine the safety and effectiveness of treating uveitis, an eye~     inflammation, with a monoclonal antibody called daclizumab. Monoclonal antibodies are~     genetically engineered proteins made in large quantities and directed against a specific~     target in the body. Daclizumab is designed to prevent a specific chemical interaction needed~     for immune cells called lymphocytes to produce inflammation. In an ongoing NIH study of 10~     adults with uveitis, 8 patients were able to decrease corticosteroids and other~     immunosuppressive medicines they were taking while receiving daclizumab for months or even~     years. Seven patients continue to take the drug.~      Patients 18 years of age and older with active non-infectious intermediate or posterior~     uveitis in both eyes who require treatment for their disease may be eligible for this study.~     Candidates will be screened with the following tests and procedures:~        -  Medical history and physical examination.~        -  Eye examination to measure visual acuity and eye pressure, and examine the lens, retina,~          pupils and eye movements.~        -  Blood tests to measure the number and types of blood cells.~        -  Fluorescein angiography to check for abnormalities of eye blood vessels. A yellow dye~          injected into an arm vein travels to the blood vessels in the eyes. Pictures of the~          retina are taken with a special camera that flashes a blue light into the eye. The~          pictures show if any dye has leaked from the vessels into the retina, indicating~          possible abnormalities.~      Participants come to the NIH Clinical Center for treatment and follow-up visits. The first~     daclizumab treatment is given as a 90-minute infusion through a vein. A second IV infusion is~     given 7 days later. If the treatment has successfully reduced the eye inflammation after 2~     weeks, then subsequent treatments are given through injections under the skin once a month~     for up to 1 year. Patients whose eye disease is not improved after 2 weeks stop the study~     treatments and receive alternative therapy.~      Follow-up visits are scheduled 7, 14, and 21 days after enrollment and at each treatment~     visit to evaluate the response to treatment and drug side effects. During these visits,~     patients repeat the exams done at screening. Extra blood samples are taken at certain visits~     to measure blood levels of daclizumab and to perform clinical laboratory and immunology~     tests. Fluorescein angiography is done at enrollment and after 1 year.~   "
267037|NCT00070642|"~     To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given~     with chemotherapy to patients with melanoma.~   "
267038|NCT00070629|"~     Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a~     taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol~     therapy will be administered until disease progression or intolerable toxicity. CpG 7909~     Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle~     (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will~     undergo complete disease evaluation at the end of every other treatment cycle until disease~     progression.~   "
267039|NCT00070616|"~     Open label palifermin will be administered to subjects who are at a risk of developing~     mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount~     of palifermin in the blood following administration will be evaluated. The safety of~     palifermin administration and its effect on reducing mucositis will also be evaluated.~   "
267040|NCT00070590|"~     Clinical and experimental studies suggest that bosentan could delay the progression of~     interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for~     which no established efficacious treatment is available. The present trial investigates a~     possible use of oral bosentan, which is currently approved for the treatment of symptoms of~     pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients~     suffering from ILD associated with SSc.~   "
267041|NCT00007839|"~     RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the~     immune system and stop cancer cells from growing.~      PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients~     who have low-grade lymphoma.~   "
267042|NCT00006482|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in~     treating patients who have refractory or recurrent cancer of the cervix.~   "
267043|NCT00006466|"~     RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the~     immune system and stop cancer cells from growing.~      PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients~     who have myeloma.~   "
267044|NCT00006257|"~     RATIONALE: Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the~     tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining SU5416 with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and paclitaxel in~     treating patients who have advanced cancer.~   "
267045|NCT00006121|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating women who have~     advanced or metastatic breast cancer that has not responded to previous chemotherapy.~   "
267046|NCT00006012|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Combining chemotherapy with radiation therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy before,~     during, and after radiation therapy in treating patients who have limited-stage small cell~     lung cancer.~   "
267048|NCT00005998|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation~     using specially treated stem cells may allow the doctor to give higher doses of chemotherapy~     drugs and radiation therapy and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation~     using specially treated stem cells in treating patients who have non-Hodgkin's lymphoma or~     Hodgkin's disease.~   "
267049|NCT00005800|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating~     women who have stage III breast cancer.~   "
267050|NCT00005794|"~     RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have~     advanced solid tumors.~   "
267051|NCT00070694|"~     This study will examine whether a highly specific and powerful 5-hydroxytryptamine 2A~     (5-HT2A) antagonist, M100907, combined with escitalopram, is responsible for an~     antidepressant effect. Major affective disorders are common and can be chronic and life~     threatening. Yet as many as 50 to 75 percent of patients get only a partial response to the~     use of antidepressants. Some do not respond to medications in the category of serotonin~     reuptake inhibitors (SSRIs)-or they experience side effects that sharply interfere with daily~     life. This study will determine the extent to which M100907 improves sleep and improves~     fatigue in people who are treated, and how it reduces cognitive impairment, that is,~     limitations to awareness, in the depressive syndrome. It will also look at allele frequencies~     as being covariates in the analysis and to collect data.~      Patients 18 to 65 years of age who meet the criteria for major depression, without psychotic~     features, may be eligible for this study. Women of childbearing potential must be using two~     medically accepted contraception methods and must agree to a (Beta)-HCG (human chorionic~     gonadotropin, a polypeptide hormone produced by the human placenta) test at the screening and~     at several intervals.~      In random groups, participants will receive treatment with escitalopram and either M100907 or~     a placebo. The timing of escitalopram can be adjusted to manage side effects. If already~     taking any other medications for psychiatric purposes, participants will be tapered from~     those medications and monitored.~      Participants will also undergo the following tests and procedures:~        -  Test of vital signs, lying and standing~        -  Physical exam~        -  12-lead electrocardiogram (SCG)~        -  Psychiatric examination for screening~        -  Thyroid screening~        -  Collection of blood for chemistry and hematology~        -  Hepatitis B and C/HIV screening~        -  Beta-HCG pregnancy test, if applicable~        -  Urine drug screening~        -  Urinalysis~        -  Tests using the Hamilton Depression Rating Scale and the Montgomery-Asburg Depression~          Rating Scale~        -  Use of the Antidepressant Treatment History~      A sleep study will be conducted during the steady state period and again toward the end of~     the double blind treatment period. Each study will involve 2 consecutive nights of~     polysomnographic recording done by an EEG technologist experienced in using the technique.~   "
267052|NCT00070564|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel,~     use different ways to stop tumor cells from dividing so they stop growing or die. Combining~     more than one drug and giving them after surgery may kill any remaining tumor cells. It is~     not yet known which combination chemotherapy regimen is more effective in treating resected~     breast cancer.~      PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination~     chemotherapy to see how well they work in treating patients who have undergone surgery for~     stage I, stage II, or stage III breast cancer.~   "
267053|NCT00070551|"~     This phase I trial is studying the side effects and best dose of GTI-2040 and high-dose~     cytarabine in treating patients with refractory or relapsed acute myeloid leukemia. GTI-2040~     may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.~     Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from~     dividing so they stop growing or die. Giving GTI-2040 together with cytarabine may kill more~     cancer cells.~   "
267054|NCT00070538|"~     RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, use different ways~     to stop cancer cells from dividing so they stop growing or die. Combining more than one drug~     may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in~     treating patients who have hematologic malignancies, including myelodysplastic syndrome or~     relapsed, refractory, or untreated leukemia.~   "
267055|NCT00070525|"~     This phase II trial is studying how well tipifarnib works in treating young patients with~     recurrent or progressive high-grade glioma, medulloblastoma, primitive neuroectodermal tumor,~     or brain stem glioma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes~     necessary for their growth.~   "
267056|NCT00070499|"~     This randomized phase IIB trial studies imatinib mesylate at two different doses and~     dasatinib to see how well they work in treating patients with previously untreated chronic~     phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
267057|NCT00070486|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton~     may stop the growth of tumor cells by stopping blood flow to the tumor and may block the~     enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or~     zileuton may kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of combining celecoxib and/or~     zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small~     cell lung cancer.~   "
267058|NCT00070473|"~     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to~     stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the~     growth of tumor cells by blocking the enzymes necessary for their growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed disodium~     in treating young patients with recurrent solid tumors.~   "
267059|NCT00070447|"~     RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan,~     can locate cancer cells and either kill them or deliver radioactive cancer-killing substances~     to them without harming normal cells. Drugs used in chemotherapy, such as prednisone,~     cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from~     dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy~     may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab and combination~     chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with~     previously untreated mantle cell lymphoma.~   "
271167|NCT00036634|"~     This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate~     (tenofovir DF).~   "
267060|NCT00070434|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, and~     oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or~     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation~     therapy with chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well different regimens of induction~     chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced~     adenocarcinoma of the rectum.~   "
267061|NCT00070421|"~     RATIONALE: Using an Internet Web site that enables children with cancer to interact online~     with classmates, participate in classroom activities, get easy-to-read medical information,~     and chat with family members, medical staff, and other children with cancer may help children~     cope with isolation, fear, and decreased self-esteem.~      PURPOSE: This phase I/II trial is studying the effectiveness of an Internet Web site in~     providing social support and education to children who are undergoing treatment for cancer.~   "
267062|NCT00070382|"~     RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and~     treat anemia in patients who are receiving chemotherapy. It is not yet known whether~     darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with~     that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for~     cancer.~   "
267063|NCT00070343|"~     RATIONALE: Drugs used in chemotherapy, such as dacarbazine, use different ways to stop tumor~     cells from dividing so they stop growing or die. Oblimersen may help dacarbazine kill more~     tumor cells by making them more sensitive to the drug.~      PURPOSE: This clinical trial is studying how well giving oblimersen together with dacarbazine~     works in treating patients with advanced malignant melanoma that previously responded to~     treatment with oblimersen and dacarbazine on clinical trial GENTA-GM301.~   "
267064|NCT00070317|"~     This clinical trial is studying how well lymph node mapping and sentinel lymph node~     identification work in finding lymph node metastases in patients with stage IB1 cervical~     cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node~     identification, performed before and during surgery, may improve the ability to detect lymph~     node metastases in patients who have cervical cancer.~   "
267065|NCT00070304|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, use different~     ways to stop cancer cells from dividing so they stop growing or die. Combining more than one~     drug may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with~     vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.~   "
267066|NCT00070291|"~     RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic~     T-cell lymphoma.~      PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients~     with recurrent or refractory angioimmunoblastic T-cell lymphoma.~   "
267067|NCT00070278|"~     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and~     gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die.~     Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed~     during surgery. It is not yet known which combination chemotherapy regimen is more effective~     in treating early breast cancer.~      PURPOSE: This randomized phase III trial is studying different regimens of combination~     chemotherapy to compare how well they work in treating women who are undergoing surgery for~     early invasive breast cancer.~   "
267068|NCT00070265|"~     Drugs used in chemotherapy, such as capecitabine and oxaliplatin, use different ways to stop~     tumor cells from dividing so they stop growing or die. Giving capecitabine and oxaliplatin~     before surgery may shrink the tumor so that it can be removed. Giving capecitabine and~     oxaliplatin after surgery may kill any remaining tumor cells. This phase II trial is studying~     how well capecitabine and oxaliplatin work when given before and after surgery in treating~     patients with resectable liver metastases that is secondary to colorectal cancer~   "
267069|NCT00070252|"~     Phase I/II trial to study the effectiveness of neoadjuvant tipifarnib combined with docetaxel~     and capecitabine in treating patients who have locally advanced or metastatic solid tumors or~     stage IIIA or stage IIIB breast cancer. Tipifarnib may stop the growth of tumor cells by~     blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as~     docetaxel and capecitabine, use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining tipifarnib with docetaxel and capecitabine may kill more tumor~     cells.~   "
267070|NCT00070239|"~     This phase I trial is studying the side effects and best dose of alvocidib in treating~     patients with metastatic or unresectable refractory solid tumors or hematologic malignancies.~     Drugs used in chemotherapy, such as alvocidib, work in different ways to stop cancer cells~     from dividing so they stop growing or die.~   "
267071|NCT00070213|"~     RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and~     oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug may kill more tumor cells. It is not yet known whether~     leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine~     with or without oxaliplatin in treating patients who have metastatic colorectal cancer.~      PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to~     compare how well they work in treating patients with metastatic colorectal cancer.~   "
267072|NCT00070200|"~     RATIONALE: Drugs used in chemotherapy, such as topotecan and cyclophosphamide, use different~     ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy~     with autologous stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy drugs and kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of induction chemotherapy using~     cyclophosphamide and topotecan in treating patients who are undergoing surgery and autologous~     stem cell transplantation followed by radiation therapy for newly diagnosed or progressive~     neuroblastoma.~   "
267084|NCT00070031|"~     RATIONALE: Drugs used in chemotherapy such as edotecarin use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well edotecarin works in treating women with~     locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.~   "
267073|NCT00070187|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Giving immunotherapy using cyclosporine, interferon gamma, and interleukin-2 after stem cell~     transplantation may help the transplanted cells make an immune response and kill any~     remaining cancer cells. It is not yet known whether high-dose chemotherapy followed by~     autologous stem cell transplantation is more effective with or without immunotherapy.~      PURPOSE: This randomized phase II/III trial is studying how well high-dose chemotherapy~     followed by autologous stem cell transplantation, cyclosporine, interferon gamma, and~     interleukin-2 works and compares it to high-dose chemotherapy followed by autologous stem~     cell transplantation only in treating patients with refractory or relapsed Hodgkin's~     lymphoma.~   "
267074|NCT00070174|"~     RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of~     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     When the healthy stem cells from a donor are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~      PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating~     young patients who are undergoing remission induction, intensification therapy, and~     allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.~   "
267075|NCT00070161|"~     RATIONALE: Donepezil and EGb761 may be effective in improving neurocognitive function (such~     as thinking, attention, concentration, and memory) and may improve quality of life in~     patients who have undergone radiation therapy to the brain.~      PURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving~     neurocognitive function in patients who have undergone radiation therapy for primary brain~     tumor or brain metastases.~   "
267076|NCT00070148|"~     RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life~     in patients with cancer. It is not yet known whether oxandrolone is more effective than~     megestrol in preventing weight loss and improving quality of life in patients who are~     receiving chemotherapy for solid tumors.~      PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works~     compared to megestrol in preventing weight loss and improving quality of life in patients who~     are receiving chemotherapy for solid tumors.~   "
267077|NCT00070135|"~     This phase II trial studies how well fludarabine and busulfan followed by a donor~     (allogeneic) stem cell transplant work in treating older patients with acute myeloid leukemia~     that is in first complete remission. Giving low doses of chemotherapy, such as fludarabine~     and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of~     cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells.~     It may also stops the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem~     cells may replace the patient's immune system and help destroy any remaining cancer cells.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells (called graft-versus-host disease). Giving tacrolimus, methotrexate, and rabbit~     antithymocyte globulin before or after the transplant may stop this from happening.~   "
267078|NCT00070122|"~     Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine,~     work in different ways to stop cancer cells from dividing so they stop growing or die.~     Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal~     antibody therapy may kill more tumor cells. It is not yet known which combination~     chemotherapy regimen with bevacizumab works better in treating colorectal cancer. This~     randomized phase III trial is studying giving two different combination chemotherapy regimens~     together with bevacizumab and comparing how well they work in treating patients with locally~     advanced, metastatic, or recurrent colorectal cancer~   "
267079|NCT00070109|"~     This phase II trial is studying how well trabectedin works in treating young patients with~     recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in~     chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they~     stop growing or die.~   "
267080|NCT00070096|"~     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with~     metastatic germ cell tumors that are refractory to cisplatin.~   "
267081|NCT00070083|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use~     different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may~     increase the effectiveness of a chemotherapy drug by making cancer cells more sensitive to~     the drug. Combining oblimersen with rituximab and combination chemotherapy may kill more~     cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of oblimersen when~     given together with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in~     treating patients with stage II, stage III, or stage IV large B-cell lymphoma~   "
267082|NCT00070070|"~     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill~     tumor cells. Biological therapies, such as BCG and sargramostim, use different ways to~     stimulate the immune system and stop tumor cells from growing. Combining vaccine therapy with~     biological therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of giving vaccine therapy together~     with BCG and sargramostim in treating patients who have undergone cystectomy for transitional~     cell cancer of the bladder.~   "
267083|NCT00070057|"~     This randomized phase I trial is studying the side effects of celecoxib in treating~     postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at~     Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by~     blocking the enzymes necessary for tumor cell growth.~   "
267085|NCT00070018|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,~     and prednisone, use different ways to stop cancer cells from dividing so they stop growing or~     die. Radiation therapy uses high-energy x-rays to damage cancer cells. Monoclonal antibodies,~     such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either~     kill them or deliver radioactive cancer-killing substances to them without harming normal~     cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill~     more cancer cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with radiation therapy and monoclonal antibody therapy works in treating patients with stage~     I or stage II non-Hodgkin's lymphoma.~   "
267086|NCT00070005|"~     RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after~     radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch~     coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring~     bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy~     and surgery to remove the rectum.~      PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis~     works compared to side-to-end coloanal anastomosis in treating patients with rectal~     adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.~   "
267087|NCT00069992|"~     Patients are being asked to participate in this study because they have a malignant blood~     disease such as Myelodysplastic Syndrome (MDS), Myeloproliferative Disorder (MPD), Acute~     Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia (CML). We feel that patients could~     benefit from an allogeneic (meaning the cells come from a donor other than themself) stem~     cell transplant. The donor would be a family member or an unrelated person that is felt to be~     a good match for the patient. Stem cells are cells that are made in the bone marrow (spongy~     material that fills the middle of the bones). As the stem cells grow, they change into~     different types of blood cells that they need. This includes red blood cells that carry~     oxygen around the body, white blood cells that help to fight infections, and platelets that~     help to prevent and stop bleeding. Usually, patients are given high doses of chemotherapy~     before a stem cell transplant. High doses of chemo destroy the bone marrow. Healthy stem~     cells from a donor are then given to replace the patient's unhealthy cells. However, because~     of complications with the patient's disease, they have a high risk of having life-threatening~     side effects. These include serious damage to organs such as the lung, liver, kidney and~     heart. There is also an increased risk of bacterial, fungal, and viral infections. The other~     major problem is when a donor's stem cells (also called the graft) find that the patient's~     cells ( the host cells) are not the same. The donor cells may try to destroy the host's~     cells. The cells at high risk are those of the skin, liver and intestines. This is called~     graft versus host disease (GVHD) and it can be fatal.~      Recently, doctors have been able to use less toxic chemotherapy treatments before patients~     receive their transplants. This less toxic treatment helps reduce some of the treatment~     related problems mentioned above. Patient's are being asked to be involved in a research~     study that uses this approach. One major risk of this low dose treatment is that the~     patient's body may reject the donor cells. This is called graft rejection. This study is~     designed to see if this low dose treatment is safe and effective.~      This treatment plan adds CAMPATH 1H (a special protein called an antibody) to a low dose~     chemotherapy regimen. After chemo, the patient will receive an allogeneic (cells come from a~     donor) stem cell transplant. Adding CAMPATH 1H to the transplant medicines may help in~     treating the disease. CAMPATH 1H may reduce life-threatening and treatment related side~     effects like GVHD. CAMPATH 1H stays active in the body for a long time which means it may~     work longer to prevent GVHD. CAMPATH 1H destroys lymphocytes, a type of white cells that help~     fight infection, and this helps prevent graft rejection.~      We want to see if the addition of CAMPATH 1H to the patient's pre-transplant low dose~     chemotherapy will decrease the side effects from an allogeneic stem cell transplant, while~     providing a curative treatment for patients with blood disorders.~   "
267088|NCT00069966|"~     RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone,~     and cisplatin, work in different ways to stop cancer cells from dividing so they stop growing~     or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have relapsed aggressive non-Hodgkin's lymphoma.~   "
267089|NCT00069953|"~     RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation~     therapy may kill more tumor cells~      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by~     chemoradiotherapy, with or without surgery, works in treating patients with resectable~     locally advanced cancer of the esophagus or gastroesophageal junction.~   "
267090|NCT00069940|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Colony-stimulating factors such as sargramostim increase the number of immune cells found in~     bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a~     stronger immune response and kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given~     together with sargramostim in treating patients with advanced sarcoma or brain tumor.~   "
267091|NCT00069927|"~     RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help~     improve memory, attention, and thinking problems caused by central nervous system (CNS)~     treatment for cancer, and may help decrease depression.~      PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how~     well it works compared to methylphenidate in treating depression and problems with memory,~     attention, and thinking in children who have undergone CNS treatment for cancer. This trial~     will also study how often depression is seen and if these medications might help.~   "
267092|NCT00006034|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. It is not yet known whether keyhole limpet~     hemocyanin is more effective than doxorubicin for bladder cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of keyhole limpet hemocyanin~     with that of doxorubicin in treating patients who have bladder cancer that has not responded~     to BCG or in those patients who cannot tolerate BCG.~   "
267093|NCT00003868|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and either kill them or~     deliver radioactive cancer-killing substances to them without harming normal cells. Drugs~     used in chemotherapy work in different ways to stop cancer cells from dividing so they stop~     growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Donor stem~     cell transplantation may be able to replace immune cells that were destroyed by radiolabeled~     monoclonal antibody therapy, chemotherapy and radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of combining radiolabeled monoclonal~     antibody with cyclophosphamide and total-body irradiation followed by donor stem cell~     transplantation in treating patients who have advanced acute myeloid leukemia.~   "
267132|NCT00004856|"~     Phase II trial to study the effectiveness of trastuzumab in treating patients who have~     previously treated, locally advanced, or metastatic cancer of the urothelium. Monoclonal~     antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to~     them without harming normal cells.~   "
267094|NCT00070577|"~     This study will examine age and sex differences in alcohol metabolism and the effects of~     alcohol. Men and women differ in their ability to metabolize alcohol, possibly due to~     differences between men and women in lean body mass, liver size, or the activity of enzymes~     that act on alcohol in the liver. Also, older men and women are thought to be more sensitive~     to alcohol, although the reasons for this are not clear.~      Healthy men and women between 21 and 25 years of age and between 55 and 65 years of age who~     are social drinkers may be eligible for this study. Candidates will be screened with~     questionnaires about their general and mental health, alcohol use, and family history of~     alcohol use and problems. They will have a physical examination, electrocardiogram (EKG),~     routine blood tests, urinalysis to test for drugs of abuse, and a blood test to study the~     gene responsible for enzymes that metabolize alcohol. Younger women will have a urine~     pregnancy test and older women will have a test to confirm post-menopausal status.~      Participants will have two study sessions at the NIH Clinical Center outpatient clinic. They~     come to the clinic by taxi and, upon arrival, take a breathalyzer test for any measurable~     alcohol levels. They are then given breakfast, after which two catheters (plastic tubes) are~     placed, one in a vein in each arm. One tube is used to collect blood samples for measuring~     hormone levels; the other is for infusing alcohol. The infusion is adjusted so that the~     breath alcohol level is held constant for about 3 hours at a moderate level. Baseline~     measurements are taken before the infusion begins. During and after the infusion, the~     participants fill out questionnaires about their moods and feelings. Breath alcohol level and~     heart rate measurements are monitored frequently. After the test, participants remain in the~     clinic until their breath alcohol level drops below 0.02 g/L (generally 2 to 3 hours after~     the infusion stops). They are given lunch and then sent home in a taxi.~      Participants also undergo a dual energy x-ray absorptiometry (DEXA) scan to determine lean~     body mass and a magnetic resonance imaging (MRI) scan of the abdomen to determine liver size.~     For the DEXA scan, the subject lies still on a table for about 30 minutes while the whole~     body is scanned using a small amount of radiation. For the MRI, the subject lies in a narrow~     metal cylinder (the scanner) about 30 minutes for the scan.~   "
267095|NCT00069901|"~     The purpose of this study is to evaluate the safety and efficacy of CT-2103~     (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients~     with Stage III or IV ovarian or primary peritoneal cancer.~   "
267096|NCT00069888|"~     This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk~     of relapse in patients with prostate cancer who have had their prostate removed by surgery,~     but are at high risk of their cancer recurring. During the trial, doctors will also closely~     monitor patients for side effects of the chemotherapy.~      Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop~     growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it~     can help shrink tumors in some patients with prostate cancer that has spread to other parts~     of their bodies. The researchers conducting this study want to determine if docetaxel also~     helps reduce the likelihood of prostate cancer returning after surgery has removed the~     original tumor.~      All of the study participants will receive up to 18 doses of docetaxel, each administered~     through a needle inserted into a vein. Each round of treatment will consist of 30-minute,~     weekly infusions for three consecutive weeks, followed by one week with no chemotherapy.~     Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that~     reduces the risk of an allergic reaction to the medication. If the side effects of the~     treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the~     trial.~   "
267097|NCT00069875|"~     The purpose of this study is to determine the effectiveness and side effects of LY293111~     given in combination with gemcitabine and cisplatin in patients with non-small cell lung~     cancer.~   "
267098|NCT00069810|"~     The purpose of this study is to determine how the progressive loss of kidney function~     influences cardiovascular disease.~   "
267099|NCT00069797|"~     To examine whether the prevalence of subclinical coronary and aortic atherosclerotic disease~     is different among Japanese in Japan, Japanese in Hawaii, and black and white Americans.~   "
267100|NCT00069784|"~     The primary objectives of the ORIGIN study were:~        -  To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular~          morbidity and/or mortality in people at high risk for vascular disease with either~          Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2~          diabetes;~        -  To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people~          with IFG, IGT or early type 2 diabetes.~      The secondary objectives of the insulin glargine study were to determine if insulin~     glargine-mediated normoglycemia can reduce:~        -  total mortality (all causes);~        -  the risk of diabetic microvascular outcomes;~        -  the rate of progression of IGT or IFG to type 2 diabetes.~   "
267101|NCT00069745|"~     PURPOSE:~      The SPARC trial is designed to compare the combination of the investigational oral cytotoxic~     drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in~     patients with hormone-refractory prostate cancer (HRPC).~      TARGET PATIENT POPULATION:~      The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC)~     and whose disease has progressed after treatment with one chemotherapy regimen. Please refer~     to the Eligibility Criteria page for the key inclusion and exclusion criteria.~      WHAT IS SATRAPLATIN:~      Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based~     drugs have been clinically proven to be one of the most effective classes of anticancer~     therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given~     orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy~     against prostate cancer in a randomized trial.~      RATIONALE:~      There are currently no approved chemotherapy drugs for the second line treatment of~     hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in~     Europe, the combination of satraplatin and prednisone had superior activity compared to~     prednisone alone, for the treatment of HRPC patients who had not previously been treated with~     chemotherapy~   "
267102|NCT00069719|"~     To determine the safety and IOP-lowering ability of a test compound in patients with~     open-angle glaucoma or ocular hypertension.~   "
267103|NCT00069706|"~     The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma~     therapy in patients with open-angle glaucoma or ocular hypertension.~   "
267133|NCT00003930|"~     RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die. Combining~     radiation therapy with chemotherapy and surgery may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination~     chemotherapy in treating patients who have stage II or stage III bladder cancer that can be~     removed by surgery.~   "
267134|NCT00003832|"~     Phase II trial to study the effectiveness of broxuridine in treating patients who are~     undergoing surgery for stage I or stage II prostate cancer. Broxuridine may help doctors~     determine the rate of growth of prostate tumors and help them plan effective treatment~   "
267135|NCT00069472|"~     Many genes are thought to contribute to rheumatoid arthritis (RA). This study will attempt to~     identify genes that may contribute to RA.~   "
267104|NCT00069914|"~     This study will evaluate how HIV infection, including CD4 cell count and viral load, affects~     the patient's ability to produce antibodies in response to vaccination with the influenza~     (flu) vaccine. Earlier studies have shown that people with HIV infection do not respond as~     well as healthy subjects to flu vaccine; that is, they don't make as many antibodies in~     response to the vaccine. Before the use of current anti-HIV medications, antibodies made to~     flu vaccination in HIV-positive individuals was related to their CD4 cell count. This trial~     will examine how CD4 counts and the amount of virus in the blood affect how much and what~     kind of antibodies the body makes to the flu vaccine.~      HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be~     eligible for this study. Healthy subjects will serve as controls to make sure the flu vaccine~     works (i.e., stimulates production of enough antibody to protect against the flu), and to~     compare the amount of antibodies made by HIV-positive and HIV-negative people. Candidates~     will be screened with a medical history and blood tests (see below). Women who are able to~     have children will have a pregnancy test. Pregnant women are excluded from the study.~      Participants will undergo the following procedures:~        1. Blood drawing for the following tests:~             -  Routine tests (complete blood count, kidney and liver functions, electrolyte~               levels).~             -  CD4 cell count.~             -  HLA typing (a genetic marker of the immune system) if it has not already been done~               at the NIH. This test may be used to try to identify factors associated with the~               rate of progression of HIV disease or related conditions. Determining HLA type is~               necessary to be able to perform certain research studies. Some HLA types have been~               associated with an increased risk of certain diseases like arthritis and other~               rheumatologic problems.~             -  Viral load (HIV-infected patients only).~             -  Influenza antibody levels.~             -  B cell levels.~        2. Flu vaccination~        3. Follow-up visits on days, 7, 28, and 54 after vaccination for the following:~             -  Review of any illnesses or fever.~             -  Review of medications, if any changes were made.~             -  Repeat blood tests.~   "
267105|NCT00069862|"~     A clinical trial designed to compare the safety and iron excretion properties of~     desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.~   "
267106|NCT00069836|"~     This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in~     combination with insulin in improving the control of blood sugar when compared with taking~     insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both~     AVANDIA and metformin are medicines which are individually licensed for the treatment of type~     II diabetes mellitus. Because they act in different ways, it is thought that combining them~     may give an increased benefit of treating diabetes and reducing blood sugar.~   "
267107|NCT00069823|"~     The purpose of this study is to determine if subjects with symptomatic asthma who are~     assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer~     asthma attacks than similar subjects assigned to placebo treatment.~   "
267108|NCT00069732|"~     The goal of this study is to pilot test in a group of overweight-obese individuals the~     feasibility and acceptability and indications of efficacy of two CAM treatments, qigong, and~     acupressure-TAT, for improving long term maintenance of weight loss.~   "
267109|NCT00069849|"~     The purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of~     ABT-089 BID to placebo in adults with Alzheimer's disease.~   "
267110|NCT00069758|"~     Summary: As this is an open label study, all patients will receive SDX-105 by 30-60 minute~     intravenous infusion on day 1 and day 2. Treatment will repeat every 21 days. Treatment can~     continue for up to one year in the absence of disease progression or unacceptable toxicity.~     Patients will be followed until disease progression.~      Rationale: Drugs used in chemotherapy, such as SDX-105, use different ways to stop tumor~     cells from dividing so they stop growing or die.~      Purpose: This study will evaluate the effectiveness and safety in non-Hodgkin's lymphoma in~     patients who are refractory to Rituxan.~   "
267111|NCT00069641|"~     The purpose of this study is to determine whether the administration of iduronate-2-sulfatase~     enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients~     with MPS II.~   "
267112|NCT00069524|"~     The primary goal of this study is to evaluate the short-term safety and potential efficacy of~     oyster mushrooms (Pleurotus ostreatus) for treatment of hyperlipidemia in HIV-infected~     patients who are taking Kaletra, a protease inhibitor (PI) that is commonly used in highly~     active antiretroviral therapy (HAART).~   "
267113|NCT00005630|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Colony-stimulating factors such as sargramostim may increase the number of immune cells found~     in bone marrow or peripheral blood.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy and sargramostim in~     treating patients who have non-small cell lung cancer.~   "
267114|NCT00005629|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     who have liver cancer.~   "
267115|NCT00004922|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have advanced neuroendocrine tumors.~   "
267116|NCT00004886|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of MS 209 plus docetaxel in treating~     patients who have advanced solid tumors.~   "
267117|NCT00069693|"~     This study will conduct tests with patients with primary chronic orthostatic intolerance~     (COI) to learn more about this disorder of the autonomic nervous system.~      Healthy normal volunteers and patients 18 years of age and older with COI may be eligible for~     this study. Participants undergo one or more of the following tests and procedures:~        -  Blood studies, including arterial catheter insertion to measure blood pressure and~          collect arterial blood samples, blood flow studies using sensors applied to the skin and~          a pressure cuff around a limb, blood volume studies using injection of radioactively~          labeled human serum albumin and gene studies to look for genetic abnormalities~          associated with certain proteins.~        -  Imaging studies, including CT scan of the adrenal glands, heart ultrasound, and PET~          scanning.~        -  Electrocardiogram~        -  Microdialysis to measures levels of chemicals in the body fluid of certain tissues. A~          thin tube is inserted into the skin and a solution is passed through it. Chemicals in~          the body tissues enter the solution in the tube. The solution is collected and the~          chemical levels are measured.~        -  Neck suction. Neck suction is applied to test a reflex the brain uses to regulate blood~          pressure.~        -  Perometry. Limb volume is measured using an infrared light that moves up the limb.~        -  Quantitative sudomotor axon reflex test to evaluate an aspect of autonomic nervous~          system function. A small amount of a brain chemical (acetylcholine) is applied to the~          skin with a tiny amount of electricity, and the sweat in a nearby patch of skin is~          measured.~        -  Skin electrical conduction test using sensors on the skin to measure sweat production.~        -  Skin and core temperature measurements using sensors on the skin and in the ear canal.~        -  Tilt table test. The subject lies on a table, secured with straps around the chest and~          legs. Sensors are placed on the arms and chest to monitor blood pressure, pulse rate,~          and heart rhythm. A catheter is placed in a vein in each arm to collect blood samples~          and give drugs. Another catheter is placed in an artery to draw blood and monitor blood~          pressure. The subject is given an infusion of norepinephrine and epinephrine, and~          baseline measures and blood samples are taken. The table is tilted upright and more~          measurements and blood samples are taken at intervals for up to 30 minutes. The table is~          returned to a horizontal position and additional measurements and samples may be taken.~      Drugs may be administered during the tests, including acetylcholine, epinephrine, and~     norepinephrine, radioactive chemicals used in imaging studies, and drugs that affect blood~     vessels, heart rate, and force of heart contractions.~   "
267136|NCT00069459|"~     A placebo controlled study evaluating the effectiveness of medication in preventing winter~     depressive episodes in patients with a history of Seasonal Affective Disorder~   "
267118|NCT00069680|"~     This study will identify and characterize the gene or genes responsible for Gray Platelet~     syndrome (GPS). Platelets are small blood cells that stick on injured blood vessels to form a~     plug and stop bleeding. When a blood vessel is injured (like a cut on a finger), platelets~     release the proteins stored in their sacs to help form a blood clot. Patients with GPS bleed~     longer than other people because their platelets lack some of these protein-carrying sacs.~     Platelets without sacs look pale gray under the microscope rather than pink, giving the~     syndrome its name. Except for rare patients with severe hemorrhage, the bleeding tendency in~     GPS is usually mild to moderate, with patients experiencing easy bruising, nosebleeds, and,~     in women, excessive menstrual bleeding.~      Patients with GPS and members of their family with GPS may be eligible for this study.~     Participants will provide a personal and family medical history and will have blood drawn.~     About 1 to 2 tablespoons of blood will be drawn in adults, and about 1 teaspoon in children.~     The blood will be analyzed for genes that cause GPS~   "
267119|NCT00069654|"~     This study will determine whether dietary nitrates and nitrites can produce nitric oxide in~     the body and dilate blood vessels in patients with coronary artery disease. Nitric oxide is~     normally made by endothelial cells that line blood vessels. It plays an important role in~     maintaining the normal function of arteries by keeping them open and preventing damage from~     substances such as cholesterol in the blood stream. Coronary artery disease is caused by~     atherosclerosis (hardening of the arteries or build-up of cholesterol and scar tissue within~     the walls of the arteries). Once arteries become clogged, the ability of the endothelium to~     produce nitric oxide diminishes considerably and may speed up the disease process, leading to~     shortness of breath, chest pain, and an increased risk of heart attack or stroke.~      Patients 21 years of age and older with coronary artery disease may be eligible for this~     study. Participants will have a medical history and physical examination, electrocardiogram~     (recording of the electrical activity of the heart), echocardiogram (ultrasound test of the~     heart), treadmill exercise stress test (see below), and will meet with a dietitian. They will~     be hospitalized at the NIH Clinical Center on two occasions. For 1 week before each~     admission, they will follow a diet prescribed by an NIH nutritionist. The diet before one~     admission will be high in nitrates and nitrites, and the diet before the other admission will~     be low in nitrates and nitrites. Each admission will last 4 days, during which participants~     will undergo the following tests:~        -  Forearm blood flow study: Small tubes are placed in the artery and vein at the inside of~          the elbow of the dominant arm (right- or left-handed) and a small tube is placed in a~          vein of the other arm. The tubes are used for infusing saline (salt water) and for~          drawing blood samples. A pressure cuff is placed around the upper part of the dominant~          arm, and a rubber band device called a strain gauge is also placed around the arm to~          measure blood flow. When the cuff is inflated, blood flows into the arm, stretching the~          strain gauge at a rate proportional to the flow. Maximum grip-strength of the dominant~          arm is measured with a dynamometer. Forearm blood flow is measured and blood samples are~          drawn at the following times: 20 minutes after the tubes are placed; during a hand-grip~          exercise; and 4 minutes after the exercise is completed.~        -  Brachial artery reactivity study: This test measures h...~   "
267120|NCT00069628|"~     This study will evaluate the safety and effectiveness of a continuous glucose monitor in~     children with Type 1 diabetes mellitus (T1DM).~   "
267121|NCT00069615|"~     Devices such as the GlucoWatch G2 Biographer (GW2B), which constantly measure blood sugar~     levels, may improve the treatment of Type 1 diabetes mellitus in children. This study~     evaluated the GW2B when used by children in their homes.~   "
267122|NCT00069602|"~     Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes~     mellitus. The purpose of this study was to determine whether two FDA-approved continuous~     glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM~     Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose~     levels in children.~   "
267123|NCT00069589|"~     Alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia~     totalis or universalis). The purpose of the registry is to collect patient information and~     blood samples from people with alopecia areata.~   "
267124|NCT00069576|"~     Gestational diabetes mellitus (GDM) is a type of diabetes (high blood sugar) that occurs in~     pregnant women. This study will determine whether treating pregnant women who have mild GDM~     improves the health of their babies. The follow-up study will examine whether factors during~     the previous pregnancy (such as blood sugar during pregnancy) are associated with the woman~     and her child's health 4-9 years later.~   "
267125|NCT00069563|"~     Children from low socioeconomic levels are more likely to have a mental disorder. However,~     they are less likely to receive appropriate treatment for that disorder than are children at~     higher socioeconomic levels. This study will evaluate a program designed to improve mental~     health services for these children through public school systems.~   "
267126|NCT00069550|"~     Rett syndrome (RTT) is a disorder in which the nervous system does not develop properly. RTT~     generally affects girls, but there are some boys who have been diagnosed with RTT. Symptoms~     of RTT include small brain size, poor language skills, repetitive hand movements, and~     seizures. This study will evaluate the effectiveness of two drugs in treating the symptoms of~     RTT.~   "
267127|NCT00069537|"~     Good control of blood glucose levels is important in preventing complications from diabetes.~     This study assessed the accuracy and reliability of two FDA-approved continuous glucose~     monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2 Biographer~     (GW2B), in children with type 1 diabetes mellitus (T1DM).~   "
267128|NCT00069511|"~     This is a multi-center study. Neither the study subjects nor the physicians will know what~     treatment an individual subject is receiving. Subjects will be randomly assigned (like~     flipping a coin) to one of five treatment groups. The treatment groups include four different~     dosing groups of active study drug and one group of subjects who will receive placebo. A 12~     week follow up period occurs after the 12 weeks of dosing. The study endpoint is a reduction~     in Hepatitis C viral load.~   "
267129|NCT00069498|"~     The lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of~     the immune system. Like other parts of the immune system, HIV attacks this lymphoid tissue.~     This study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in~     the gastrointestinal tracts of people with HIV.~   "
267130|NCT00069485|"~     The immune systems of some individuals may be capable of resisting HIV infection. These~     individuals do not appear to be infected with HIV despite multiple sexual encounters with HIV~     infected partners. This study will examine the immune systems of these individuals to~     determine what factors are responsible for their ability to resist HIV infection.~      Study hypothesis: Some long-term, multiply-exposed seronegative persons have relative~     resistance to HIV infection maintained by T cell responses.~   "
267131|NCT00004883|"~     Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage~     IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies~     can locate tumor cells and either kill them or deliver tumor-killing substances to them~     without harming normal cells~   "
267137|NCT00069446|"~     This is a Phase I, double blind, randomized, placebo-controlled study that will enroll~     approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic~     foot ulcers. The study will be conducted at approximately 12 investigational sites in the~     United States.~   "
267138|NCT00069368|"~     This study consists of two studies with overlapping cohorts. One is a follow up~     epidemiological study of urinary incontinence, the other is a case control study of lower~     urinary tract dysfunction in women with diabetes.~      Study One:~      Subjects for the study will be a retrospective cohort of 2100 middle-aged and older women~     from a large health maintenance organization who have participated in the Reproductive Risk~     Factor for Incontinence Study at Kaiser (RRISK). The RRISK I study assembled a retrospective~     cohort of long-term female Kaiser Permanente members to determine the association between~     specific childbirth events, hysterectomy, hormone use and urinary incontinence later in life.~     The study also provides descriptive information on urinary incontinence by type, age,~     ethnicity, severity and age of onset.~      Study Two:~      Women with diabetes have a 30-70% increased risk of lower urinary tract dysfunction,~     including lower urinary tract symptoms, urinary incontinence, and ultimately bladder~     cystopathy. This sudy investigates the natural history, risk factors, and possible mechanisms~     of lower urinary tract dysfunction and infection among women with type 2 diabetes as compared~     to women without diabetes.~   "
267139|NCT00069420|"~     This study will evaluate the effectiveness of cognitive motivational behavior therapy (CMBT)~     in treating pathological gamblers.~   "
267140|NCT00069407|"~     This study will compare the antidepressant benefits and cognitive side effects of three~     different types of electroconvulsive therapy (ECT) in people with unipolar or bipolar~     depression.~   "
267141|NCT00069381|"~     This study will compare one- and two-component treatments in women with post-traumatic stress~     disorder (PTSD).~   "
267142|NCT00003827|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more cancer cells.~     Chemoprotective drugs such as amifostine may protect normal cells from the side effects of~     chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine~     given with amifostine in treating patients who have myelodysplastic syndrome.~   "
267143|NCT00003620|"~     Phase II trial to study the effectiveness of flavopiridol in treating patients who have~     chronic lymphocytic leukemia that has not responded to treatment with fludarabine. Drugs used~     in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die~   "
267144|NCT00003594|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of combination chemotherapy is most effective in treating advanced~     colorectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of various combination~     chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic~     colorectal cancer that cannot be treated with surgery or radiation therapy.~   "
267145|NCT00003540|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating women with~     metastatic breast cancer previously treated with doxorubicin and paclitaxel.~   "
267146|NCT00003463|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in~     treating patients with recurrent supratentorial high grade gliomas.~   "
267147|NCT00069355|"~     This 10-week study will examine whether propranolol, a medication that blocks the activity of~     the stress hormones adrenaline and noradrenaline, can relieve acute stress disorder (ASD) and~     symptoms from persisting long-term. ASD is a condition that some people develop soon after~     exposure to trauma. They may be anxious, depressed, have trouble sleeping, startle easily,~     have difficulties concentrating, and feel as though the event is happening again. Propranolol~     has been used for many years to treat high blood pressure and heart disease, and has been~     found useful in treating anxiety states such as social phobia and migraine.~      Men and women between 18 and 65 years of age who were recently exposed to trauma (between 1~     and 3 weeks of evaluation in this study) may be eligible for this study. Candidates must be~     diagnosed with ASD and must have been mentally healthy before the traumatic event. They will~     be screened for the study with a medical and psychiatric interview, physical examination,~     electrocardiogram (EKG), and blood and urine tests.~      Participants will be evaluated with the following procedures:~        -  Neuropsychological tests using pen-and-paper and computer tests to evaluate cognitive~          function, particularly memory, learning, attention and concentration, and vocabulary and~          naming.~        -  Emotion-related performance tasks to determine if the study medication can weaken~          emotionally arousing information by blocking the activity of adrenaline and~          noradrenaline. Subjects perform emotion-related and neutral tasks, such as looking at~          pictures with neutral, pleasant, or unpleasant content, both before and after treatment~          with the study medication (see below).~        -  Traumatic script exposure: Subjects recount the traumatic event that caused them to~          develop ASD. The description is summarized, recorded, and played back to the subject.~          During the playback, physiological responses, such as heart rate and skin conductance~          (sweating), are recorded using electrodes taped to the hand and chest.~        -  Fear conditioning to evaluate the response to an unpleasant stimulus: Several mild~          electrical shocks are delivered to the wrists while the subject looks at colored~          squares. Heart rate and skin conductance are measured.~        -  Magnetic resonance imaging (MRI) to examine brain structure. The subject lies on a table~          that is moved into the MRI scanner (a narrow cylinder containing a strong magnetic~          field) and must remain still during the actual scanning. Earplugs are worn to muffle~          loud noises caused by electrical switching of radio frequency circuits used in the~          scanning process.~      After the evaluation, participants are randomly assigned to receive either propranolol or~     placebo (a look-alike pill with no active ingredient) for 8 weeks During this time they are~     seen by a doctor once a week for 4 weeks and then once every other week for the rest of the~     study. At the end of the 8-week treatment period, participants undergo the same evaluation~     they had before beginning treatment (see above). The decision to continue treatment will then~     be decided based on the individual's clinical condition and whether he or she received~     propranolol or placebo.~   "
267148|NCT00069342|"~     This study will explore the diverse health beliefs and behaviors among minority patients with~     rheumatic diseases. These diseases may cause joint pain, stiffness or swelling. Some can~     involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune~     system-the body's defense against disease. Some rheumatic diseases are painful or deforming~     and some can be life-threatening. Many rheumatic diseases occur more often and more severely~     in certain minority communities. This study will explore psychosocial and cultural factors~     related to rheumatic disease in minorities.~      Patients enrolled in the NIAMS protocol Natural History or Rheumatic Disease in Minority~     Communities (protocol #01-AR-0227) may participate in this study. Participants will be~     evaluated at the NIAMS Community Health Center at the Upper Cardozo Health Center in~     Washington, D.C.~      Participants will be interviewed about individual and community health behavior, and health~     beliefs about rheumatic disease and its effects on several areas of their life, including~     mood and physical activity. The interview will be in one of the following formats: 1)~     in-depth cognitive interview, 2) focus group, or 3) face-to-face interview, as follows:~      In-Depth Cognitive Interview~      Participants take part in a one-time interview conducted by one investigator, observed by~     another, and tape recorded. The interview lasts from 1 to 2 hours.~      Focus Groups~      Participants take part in a group interview of from 6 to 10 people during a one-time~     tape-recorded session that lasts from 2 to 2-1/2 hours. The group discussion is led by a~     moderator and a facilitator, who takes notes and makes observations.~      Face-to Face Interview~      Participants are interviewed twice - first upon enrollment at the NIAMS Community Health~     Center and again after 6 months' follow-up at the Center.~   "
267149|NCT00069277|"~     The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are~     those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in~     vitro and in vivo. The ultimate goal is to demonstrate the clinical activity of E7389 in the~     treatment of these, and potentially other, tumor types.~   "
267150|NCT00069264|"~     To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that~     have progressed following standard therapy or for which no standard therapy exists.~   "
267151|NCT00069251|"~     The purpose of this study is to assess the efficacy and safety of bupropion in reducing~     methamphetamine use in subjects with methamphetamine dependence~   "
267152|NCT00003449|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and~     gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.~   "
267153|NCT00003281|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating~     patients who have recurrent or refractory small cell lung cancer.~   "
267190|NCT00068874|"~     This study will evaluate a program designed to help African American adolescents with lupus~     (systemic lupus erythematosus or SLE) cope with the disease.~   "
267154|NCT00003280|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. It is not yet~     known which treatment regimen is more effective for lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     rituximab in treating patients who have follicular or mantle cell lymphoma.~   "
267155|NCT00003245|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with~     recurrent or refractory non-Hodgkin's lymphoma.~   "
267156|NCT00003113|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving the drugs in different ways~     may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of oral combination chemotherapy and G-CSF~     in elderly patients with intermediate- or high-grade non-Hodgkin's lymphomas.~   "
267157|NCT00069329|"~     This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating~     patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic~     infantile neurological, cutaneous and arthropathy (CINCA) syndrome. This disease can cause~     rash, joint deformities, brain inflammation, eye problems, and learning difficulties. Immune~     suppressing medicines commonly used to treat other pediatric rheumatologic diseases do not~     suppress NOMID symptoms and, if used long-term and in high doses, can cause harmful side~     effects. Anakinra, approved by The Food and Drug Administration for treating rheumatoid~     arthritis in adults, blocks a substance called IL-1 that may be an important factor in~     causing the inflammation in NOMID.~   "
267158|NCT00069316|"~     Investigators will assess whether Omr-IgG-am(Trademark), an intravenous immunoglobulin (IVIg)~     containing antibodies specific for West Nile virus (WNV), is safe and well-tolerated in~     patients with suspected or laboratory diagnosed WNV disease. An initial estimation of~     efficacy will also be made.~      This Phase I/II study will enroll hospitalized adults with a presumptive diagnosis of West~     Nile encephalitis and/or myelitis or those with a positive laboratory test for diagnosis of~     WNV infection who are at high risk for progressing to severe neurologic disease based on age~     or immunosuppression. Patients will be randomized in blocks of five to receive either~     Omr-IgG-am(Trademark), Polygam(Registered Trademark) S/D (IVIG containing minimal anti-WNV~     antibodies) or normal saline in a ratio of 3:1:1. Patients and investigators will be blinded~     to treatment assignments.~      Patients will receive a single intravenous dose of study medication or one of two placebos.~     The study participants will receive 0.5 grams/kg of Omr-IgG-am(Trademark) or~     Polygam(Registered Trademark) S/D or a comparable volume of normal saline. All patients will~     be followed for safety, natural history endpoints, and efficacy. A subset of patients will~     have pharmacokinetic measurements of specific anti- WNV antibodies assessed following~     treatment.~      The primary endpoints are safety and tolerability following Omr-IgG-am(Trademark)~     administration.~      Secondary endpoints include pharmacokinetics of specific anti-WNV antibodies, mortality in~     confirmed WNV positive patients, and the combination of mortality and functional status at~     three months in both confirmed WNV-infected patients and all patients by intention to treat.~     This combined endpoint will be measured using four standardized measures of cognitive and~     functional status: the Barthel Index; the Modified Rankin Scale; the Glasgow Outcome Score;~     and the Modified Mini-Mental Status Examination. A comparison of outcomes will be made for~     the group receiving Omr-IgG-am(Trademark) versus those receiving either placebo, and between~     the two placebo groups. Other secondary endpoints include the proportion of patients in each~     group returning to pre-morbid baseline and each subject's improvement at 3 months as compared~     to that subject's worst (of any previous) evaluation.~      Natural history endpoints will also be assessed. They will include the duration of intensive~     care unit (ICU) and hospital stay, development and persistence of WNV-specific IgG and IgM~     antibodies, combined functional score and mortality at 3 months between the group with~     encephalitis and/or myelitis at baseline versus the group with a positive WNV test only,~     outcomes in patients treated late in coma and correlation of outcome with time-to-treatment~     following symptom onset.~   "
267159|NCT00069303|"~     This study will examine how West Nile virus (WNV) infection affects the body. Some people~     infected with WNV have no symptoms. In others, symptoms may vary from fever and headache to a~     polio-like syndrome with paralysis, to coma and brain changes like those of a stroke. Many~     patients recover with no lasting effects, while a few can have long-lasting neurological~     damage or may die. This study will collect clinical, laboratory, diagnostic, and radiographic~     information on people thought to have WNV to better understand the disease.~      Patients 18 years of age and older diagnosed with or suspected of having West Nile virus~     infection may be eligible for this study. Patients will be hospitalized until they are well~     enough to go home and will undergo the following tests and procedures:~        -  Medical history and physical examination: A thorough history and physical examination~          will be done on the first day of the study. Then, brief physical exams, including~          measures of blood pressure, heart rate, breathing rate, and temperature, will be done~          during each day of hospitalization and at every follow-up clinic visit (at 2 weeks and~          at 1, 3, and 6 months).~        -  Blood tests: Blood samples will be collected on the first day of the study, at day 7, at~          hospital discharge, and at follow-up visits to determine if virus remains in the blood~          and how it is affecting the body.~        -  Magnetic resonance imaging (MRI): MRI scans will be done within 72 hours of beginning~          the study and 1 month after that. This test uses a strong magnetic field and radio waves~          to produce images of the brain that might show abnormalities in the brains of patients~          with WNV and reveal whether the abnormalities can predict how an individual will~          recover. For the procedure, the patient lies on a table that is moved into the narrow~          tunnel-like scanner. During the procedure, a contrast agent that brightens the images is~          injected through a catheter placed in an arm vein.~        -  Neurological examination and neurological function tests: Participants will be tested to~          see if the West Nile virus has affected their thinking and ability to perform normal~          daily activities. These tests will be done at the start of the study, on days 3 and 7~          (also days 2, 4, 5, and 6 if patients are still in the hospital), at discharge, and at~          follow-up visits. The tests involve answering a number of questions and performing~          simple tasks, such as squeezing a hand or lifting a foot.~        -  Patients who develop weakness in their arms or legs will also have the following~          studies:~             1. Electromyography (EMG) to study the electrical activity of the muscle. For this~               test, needles are placed into a muscle to record the electrical activity at that~               site.~             2. Nerve conduction studies to measure how well the nerves are working. A small charge~               of electricity is delivered to a nerve in the affected limb, triggering a muscle to~               tighten or bend. Small wire electrodes are attached to the skin to measure the time~               is takes for the nerve to move the electrical current from one part of the limb to~               another.~             3. Spinal MRI to see if the virus is affecting the spinal cord.~      Results of other tests done by the patient's local doctor (such as lumbar puncture,~     electroencephalogram, x-rays, etc.) will be requested. If a lumbar puncture is done, a small~     amount of cerebrospinal fluid will be requested for testing for WNV.~   "
267160|NCT00069186|"~     The purpose of this study is to determine whether nine months of administration of creatine~     monohydrate results in an increase in muscle strength in patients with amyotrophic lateral~     sclerosis (ALS).~   "
267161|NCT00069238|"~     Background:~      The paradigm of combining therapeutic agents with non-overlapping toxicities for the~     treatment of malignancy produces clinical remissions and cures in a number of tumor types.~      A new class of agents, humanized and chimerized monoclonal antibodies, typically have little~     or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic~     chemotherapy. It has become clear that in certain lymphomas and breast cancers, the~     combination of monoclonal antibodies and chemotherapy improves response rate and the quality~     of the response compared with that achieved by treatment with either agent alone.~      The clinical outcome for patients with T-cell non-Hodgkins lymphoma is significantly inferior~     to the outcome of patients with B-cell non-Hodgkin s lymphoma. In most reports less than 20%~     of patients with T cell lymphoid malignancies remain free of disease at 5 years.~      Objectives:~      Determine the toxicity of Alemtuzumab and etoposide, prednisone, vincristine,~     cyclophosphamide, doxorubicin (EPOCH) chemotherapy in untreated cluster of differentiation 52~     (CD52)-expressing T and natural killer (NK) lymphoid malignancies.~      Determine the maximum tolerated dose of Alemtuzumab administered in combination with EPOCH~     chemotherapy.~      Determine in a preliminary fashion the anti-tumor activity of the combination of Alemtuzumab~     and EPOCH chemotherapy.~      Eligibility:~      CD52-expressing lymphoid malignancy.~      Patients with chemotherapy naive aggressive T & NK lymphomas. Patients with alk-positive~     anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible.~      Age greater than or equal to 17 years.~      Adequate organ function, unless impairment due to respective organ involvement by tumor.~      No active symptomatic ischemic heart disease, myocardial infarction or congestive heart.~     failure within the past year.~      Human immunodeficiency virus (HIV) negative.~      Not pregnant or nursing.~      Design:~      Three dose levels of Alemtuzumab will be evaluated to determine the toxicity profile and in a~     preliminary fashion the antitumor activity of the combination with Dose-Adjusted EPOCH.~      Three dose levels of Alemtuzumab will be explored, in cohorts of three to six patients each.~     Patients will receive either 30, 60, or 90 mg of Alemtuzumab on day 1 of therapy, followed by~     dose-adjusted EPOCH chemotherapy days 1-5.~   "
267162|NCT00069225|"~     This study, conducted at the University of Pennsylvania and at the National Institutes of~     Health in Bethesda, Maryland, will examine deficits in brain structure and function in people~     exposed to trauma who developed post-traumatic stress disorder (PTSD) to see if these~     deficits change after treatment. It also will investigate whether there is a genetic~     susceptibility to PTSD.~      Candidates 18 years of age and older in the following categories will be included in this~     study: 1) women who have PTSD of at least 1 year's duration following sexual or non-sexual~     assault; 2) healthy women (controls) who were previously assaulted but did not develop PTSD;~     and 3) healthy women (controls) who were never traumatized. Candidates will be screened with~     a medical history and physical examination, psychiatric evaluation, electrocardiogram (EKG),~     and routine blood and urine tests.~      Women with PTSD will be assigned to receive either: 1) 12 weeks of cognitive behavioral~     psychotherapy either immediately upon enrollment or after a 3-month waiting period; or 2) 10~     weeks of drug treatment with paroxetine (Paxil® (Registered Trademark)). Patients will be~     evaluated before and after treatment with the procedures outlined below. Control subjects~     will undergo the same procedures, also with a 10- to 12-week interval between evaluations.~        -  Neuropsychological testing: Subjects will take paper and pencil and computer tests to~          evaluate memory, learning, attention and concentration, vocabulary and naming.~        -  Magnetic resonance imaging (MRI): Subjects will have MRI scans of the brain to examine~          brain structure and blood flow while they perform two tasks. In the first task, they~          will be shown a series of faces and asked to press one button for a male face and~          another button for a female face. In the second task they will hear loud noises and see~          colored squares. During the scan, subjects lie on a bed that slides into a narrow tunnel~          (the scanner). They will wear a headset to block the noise of the scanner and through~          which they will receive instructions for the tasks. Heart rate and skin conductance~          (sweating) will be measured during the scan to evaluate physiologic changes in response~          to the tasks.~        -  Eyeblink air puff test: Subjects will hear tones and will have a light puff of air~          delivered to the eye. Changes in heart rate, sweat, and eyeblink will be measured with~          electrodes taped to the skin on two fingers, on each side of the rib cage, and under one~          eye.~        -  Potential air puff delivery: This experiment has three parts. During each of the three~          parts of this experiment, subjects will see colored lights and may or may not receive a~          puff of air to the neck. Before each part they will be told that they will, will not, or~          may receive an air puff to the neck. Each part will be repeated several times. During~          the test, electrodes will be taped to the arms and chest to monitor skin conductance and~          heart rate responses.~        -  Blood draw for genetic evaluation: Subjects' DNA will be examined to try to determine if~          the risk of developing PTSD is inherited. The DNA will be examined for cortisol receptor~          gene evaluation, to see if a form of this gene is found more often in patients with PTSD~          than in healthy controls. The receptor for cortisol determines the activity of the~          stress hormone cortisol, and genetic variations in the structure of this receptor may be~          related to vulnerability to PTSD.~      Patients taking paroxetine will be offered up to 3 months of additional drug therapy~     following completion of the study and will be offered participation in other NIH studies for~     evaluation and treatment of PTSD.~   "
267163|NCT00069212|"~     This study will evaluate brain changes and psychological characteristics of people who are~     resilient to trauma. It will examine and compare responses in three categories of subjects:~     1) people who have been exposed to a significant traumatic event and suffer symptoms of~     post-traumatic stress disorder (PTSD) severe enough to interfere with their ability to~     function; 2) people who have been exposed to a significant traumatic event and do not suffer~     PTSD symptoms severe enough to interfere with their ability to function; and 3) people who~     have never been exposed to a significant traumatic event. Most people who are exposed to~     trauma recover well from the adversity. Some may even benefit from it by, for example,~     gaining greater self-confidence of strengthening personal relationships. Others, however,~     develop PTSD and may have repeated thoughts, images, and dreams of the trauma; feel upset~     when reminded of the traumatic event; avoid places or people that remind them of the trauma;~     feel detached from others; have difficulty sleeping and concentrating; or startle easily.~      People in the three categories listed above may be eligible for this study. Candidates will~     be screened with a medical and psychiatric interview, evaluation of emotional intelligence~     (sensitivity to feelings of others), physical examination, electrocardiogram (EKG) and blood~     tests.~      Participants will undergo the following additional tests and procedures:~        -  24-hour urine collection and three urine drug screens over the course of the study.~        -  Saliva collection every 2 hours on the day of the urine collection.~        -  Magnetic resonance imaging (MRI) scans of the brain: Subjects will have three MRI~          scanning sessions to show brain structure and changes in blood flow in different regions~          of the brain that are responsible for emotion. MRI uses a strong magnetic field and~          radio waves to produce images of body tissues. During the scan, the subject lies on a~          table in a narrow cylinder containing a magnetic field and may wear earplugs to muffle~          loud sounds that occur during the scanning process. While in the scanner, the subject is~          shown pictures of faces, houses, or words and performs tasks that involve making~          decisions about the pictures Subjects are also shown pleasant, unpleasant, and neutral~          pictures; and they are asked to play two games of chance - one that evaluates social~          cooperation; the other evaluating decision-making. Heart rate, blood pressure and~          respiration are measured during the scans.~        -  Neuropsychological testing: These tests are designed to evaluate memory, learning,~          attention and concentration, and naming.~        -  Aversive conditioning: This procedure examines how the body reacts to unpleasant~          stimuli, such as a mildly unpleasant electrical stimulation to the wrist or a loud~          sound, over time. During the test, heart rate, electrodermal activity (sweat),~          respiration, finger pulse volume, and eyeblink responses will be measured. A small blood~          sample will be drawn every 5 minutes to evaluate plasma levels of various stress~          hormones, including cortisol, neuropeptide Y, norepinephrine, and others.~        -  Genetic and biological testing: Patients who agree to genetic testing will have a blood~          sample drawn for DNA studies to better understand the biology and pharmacology of PTSD.~   "
267164|NCT00069199|"~     This study, conducted at the NIH Clinical Center and the University of Wisconsin University,~     will compare measurements obtained using older and newer models of a machine called an~     optical coherence tomography (OCT) scanner. This instrument uses a beam of light to measure~     the thickness of the retina, the light-sensitive inner lining of the back of the eye. OCT~     measurements will be done in multicenter clinical trials of new treatments for disorders that~     cause vision loss, such as macular edema. Because some centers in these studies will use the~     older OCT model and some the newer one, it is necessary to determine whether the two models~     give comparable results.~      People 18 years of age and older in the following categories may be eligible for this study:~        -  People with diabetes, with or without macular edema;~        -  People with other retinal disease, such as uveitis or vein occlusion in the retina;~        -  People with no history of eye disease who have a normal retina.~      Participants will have the following tests and procedures:~        -  Eye examination to assess vision and eye pressure and to evaluate the retina. The pupils~          are dilated with drops for this examination.~        -  Stereoscopic color fundus photography to examine the back of the eye. Eye drops are used~          to enlarge the size of the pupils to allow for a through examination and photographs of~          the eye using a special camera that flashes a bright light into the eye.~        -  OCT to measure retinal thickness. For this procedure, the subject sits in front of a~          small screen and looks at a target in the center of the screen while a dim red light~          moves across the subject's retina. This test is done first with one model of the OCT~          scanner, then the other. Finally, the test is repeated in both eyes with whichever model~          was used first.~      Patients who are being treated for macular edema will repeat the same tests at their 3-month~     visits.~   "
267165|NCT00069121|"~     This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus~     Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery~     for colon cancer and no previous chemotherapy. Patients will be randomized to receive either~     1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or~     2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment~     is until disease progression and the target sample size is 500+ individuals.~   "
267166|NCT00069108|"~     This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv~     fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients~     previously treated for metastatic colorectal cancer. Patients will be randomized to receive~     either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)~     FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study~     treatment is until disease progression, and the target sample size is 500+ individuals.~   "
267167|NCT00069095|"~     This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or~     intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with~     or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic~     colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m^2 orally~     [po] twice a day [bid] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin~     + leucovorin + fluorouracil [5-FU] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on~     Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).~   "
267168|NCT00002638|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation in treating children who have relapsed acute lymphocytic~     leukemia.~   "
267169|NCT00002559|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting~     of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular~     germ cell tumors that are refractory to platinum-containing chemotherapy.~   "
267170|NCT00002533|"~     RATIONALE: Giving fluconazole may be effective in preventing or controlling mucositis caused~     by radiation therapy to the head and neck.~      PURPOSE: Randomized phase II/III trial to study the effectiveness of fluconazole in~     preventing mucositis in patients undergoing radiation therapy for head and neck cancer.~   "
267171|NCT00069173|"~     Physical activity in adolescents is an important part of bone health. Good bone health in~     adolescents can decrease the risk of osteoporosis. This study will evaluate a program~     designed to increase the level of physical activity in adolescent girls.~   "
267172|NCT00069134|"~     It is believed that the organs of severely malnourished children malfunction because harmful~     compounds called oxidants injure the tissues in these organs. In a healthy person oxidants~     are made harmless because another compound called glutathione neutralizes them. Glutathione~     is made from three amino acids that we get from the protein we eat in our food. We found that~     malnourished children were not making enough glutathione because they lacked one of these~     amino acids called cysteine. In this study we determine why malnourished children do not have~     sufficient cysteine, and we will feed malnourished children a whey-based diet which is rich~     in cysteine during their treatment to determine whether they will make more glutathione. This~     in turn may make their organs recover faster. These findings will let us know whether~     malnourished children can recover faster if they are given more cysteine during the early~     phase of treatment.~   "
267173|NCT00069017|"~     To compare, as a preliminary analysis, the effects of MEDI-522 versus placebo at 6 months on~     disease activity (ACR20) and progression of structural joint damage.~   "
267174|NCT00030381|"~     Iododoxorubicin may dissolve protein deposits and be an effective treatment for primary~     systemic amyloidosis. Phase I trial to determine the effectiveness of iododoxorubicin in~     treating patients who have primary systemic amyloidosis~   "
267175|NCT00026286|"~     RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or~     vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement~     therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are~     receiving tamoxifen for breast cancer.~   "
267176|NCT00025116|"~     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells~     and slow the growth of prostate cancer. It is not yet known which dose of ZD 1839 is more~     effective in treating prostate cancer that has not responded to hormone therapy.~      PURPOSE: Randomized phase II trial to compare different doses of ZD 1839 in treating patients~     who have prostate cancer that has not responded to hormone therapy.~   "
267177|NCT00069160|"~     The purpose of this study is three-fold: 1) to examine the ability of the experimental drug~     tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some~     cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the~     cancer drug docetaxel; and 3) evaluate the effectiveness of combination treatment with~     tariquidar and docetaxel in treating patients with lung, ovarian, or cervical cancer.~      Patients 18 years of age and older with recurrent or metastatic (spreading) lung, cervical,~     or ovarian cancer who cannot benefit from any standard treatment may be eligible for this~     study. Candidates will be screened with a medical history and physical examination; review of~     pathology slides; blood and urine tests; imaging tests, including computed tomography (CT) or~     magnetic resonance imaging (MRI) scans; chest x-ray, electrocardiogram (EKG); and possibly~     echocardiogram.~      Participants will undergo the following tests and procedures:~      Blood draw. Blood is drawn before treatment begins to establish baseline levels for future~     blood tests. Blood counts are done twice weekly after chemotherapy begins.~      Central venous catheter placement. A plastic tube is put into a major vein in the chest. It~     is used to give the study drugs or other medications, including antibiotics and blood~     transfusions, if needed, and to withdraw blood samples. The line is usually placed under~     local anesthesia in the radiology department or the operating room. It can stay in the body~     for months or be removed after each treatment is completed.~      Chemotherapy. Treatment cycles are 21 days. Both drugs are given on day 1 of each cycle.~     First, tariquidar is given as a 30-minute infusion. One hour after the tariquidar infusion,~     docetaxel is infused over 1 hour. (For the first cycle only, docetaxel is given in divided~     doses one week apart and tariquidar is administered on either day 1 or day 8. The order of~     tariquidar administration is randomized to generate optimal pharmacokinetic data. Patients~     will be hospitalized for several days during this cycle to gather research data). The~     tariquidar dose remains the same throughout the study. Docetaxel may be increased or~     decreased from cycle to cycle, based on side effects.~   "
267178|NCT00069082|"~     This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in~     the treatment of an episodic cluster headache period compared to placebo (medically inactive~     substance which does not contain any active ingredients).~   "
267221|NCT00068380|"~     Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth. This phase II trial is studying how well imatinib mesylate works in~     treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal~     junction cancer.~   "
267179|NCT00069030|"~     This study will test the safety of and immune system response to a new HIV vaccine. The~     vaccine in this study is made from HIV DNA produced in a laboratory. Only part of the virus's~     DNA is used in the vaccine and the vaccine itself cannot cause HIV infection or AIDS. In~     addition to HIV DNA, the vaccine contains interleukin-2 (IL-2) DNA fused to a portion of~     immunoglobulin (Ig) DNA. IL-2 is a chemical that stimulates the immune system and may improve~     response to the vaccine.~      Study hypothesis: The IL-2/Ig plasmid will be very well tolerated in humans.~   "
267180|NCT00069004|"~     The purpose of this study is to assess the prevalence of metabolic and physical abnormalities~     in HIV infected (via mother-to-child transmission) and uninfected children and youth.~     Metabolism, body composition, bone density, and other factors will be assessed in~     relationship to participants' exposure to highly active antiretroviral therapy (HAART).~   "
267181|NCT00068991|"~     The purpose of this study is to determine whether two educational programs about HIV will~     improve the quality of life of HIV infected people living in the rural villages of China. The~     study will enroll HIV infected adult residents, influential community members, and other~     community members of selected villages of Funan County or Yingzhou District, Anhui Province,~     China.~   "
267182|NCT00068978|"~     This study will evaluate a test designed to measure immune system responses to HIV and HIV~     vaccines.~   "
267183|NCT00068952|"~     The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor~     glioblastoma multiforme (GBM) who have progression or first recurrence following initial~     treatment with surgery, radiation and chemotherapy.~   "
267184|NCT00069069|"~     This study will determine the maximum safe dose of the experimental drug E-selectin that can~     be given to stroke patients. E-selectin causes white blood cells called lymphocytes to change~     so that they prevent clots from forming in the vessels that supply blood to the brain. The~     drug has been shown to be effective in animal models of stroke. This study will look at the~     safety of using this experimental drug in nasal instillation form in patients who have had a~     stroke or transient ischemic attack (TIA).~      Patients 45 years of age or older who have had a recent stroke or TIA (30 to 120 days before~     entering the study) due to a clot forming in a vessel that supplies blood to the brain may be~     eligible for this study. They must be taking at least one medication to prevent clots, such~     as coumadin, aspirin, ticlopidine, or others. Candidates will be screened with a physical and~     neurological examination, blood and urine tests, electrocardiogram (EKG), echocardiogram~     (ultrasound test of the heart), and magnetic resonance imaging (MRI) of the brain.~      Participants will be randomly assigned to receive E-selectin at a dose level of 5, 15, or 50~     micrograms or a placebo (nasal drops with no active ingredient). They will instill a small,~     carefully premeasured amount (one dose) of fluid in their nose every other day for 10 days~     (total of 5 doses). This course of treatment will be repeated two times at 3-week intervals.~     Patients will be followed at 1 month and 3 months with a neurologic examination and blood and~     urine tests. They will be contacted by phone, fax, or email in between these two visits.~   "
267185|NCT00069056|"~     This study will compare the side effects of two laser treatments for diabetic macular edema,~     a common condition in patients with diabetes. In macular edema, blood vessels in the retina,~     a thin layer of tissue that lines the back of the eye, become leaky and the retina swells.~     The macula, the center part of the retina that is responsible for fine vision, may also swell~     and cause vision loss. Traditional laser treatment (argon blue or green, or yellow) for~     macular swelling, or edema, causes scarring that can expand and possibly lead to more loss of~     vision. A different laser technique, the mild macular grid, uses lighter laser burns through~     the macula and may be less damaging to the eye, but this is not known. This study will~     compare the two techniques and the information on side effects will be used to design a~     larger study of whether one laser is more effective than the other.~      Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be~     eligible for this study. Candidates will be screened with the following tests and procedures:~        -  Medical history and physical examination.~        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to~          examine pupils, lens, retina and eye movements. The pupils will be dilated with drops~          for this examination.~        -  Blood tests to measure cholesterol levels, hemoglobin A1C (a measure of diabetes~          control), and creatinine (measure of kidney function).~        -  Eye photography to help evaluate the status of the retina and changes that may occur in~          the future. Special photographs of the inside of the eye are taken using a camera that~          flashes a bright light into the eye.~        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected~          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina~          are taken using a camera that flashes a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating possible blood vessel~          abnormality.~        -  Optical coherence tomography to examine retinal thickness. The eye is examined with a~          machine that produces cross-sectional pictures of the retina. These measurements will be~          repeated during the study to determine whether retinal thickening is getting better,~          worse, or staying the same.~      Participants will be randomly assigned to one of the two laser therapies in the eye with~     macula edema. (Patients with macular edema in both eyes will receive both treatments-one in~     each eye.) For these procedures, eye drops are put in the eye to numb the surface, and a~     contact lens is placed on the eye during the laser beam application. Several visits may be~     required for additional laser treatments. The number of treatments depends on how well they~     are working. Patients will return for follow-up visits 4, 8, and 12 months after the first~     treatment, and then every year until year 3. During the follow-up visits, the response to~     treatment will be evaluated with repeat tests of several of the screening exams.~   "
267186|NCT00068900|"~     We will give intravenous fat molecules to help us understand how the fat that is released~     from peoples fat cells is used. This will be done when people are eating, not eating and~     walking.~   "
267187|NCT00068887|"~     There are several studies looking at how dietary fat is metabolized by humans. We give~     special meals and collect blood, breath, urine and fat samples to study how people burn and~     store dietary fat.~   "
267188|NCT00068926|"~     This protocol will screen healthy normal volunteers for participation in studies of vaccines~     under development at NIAID's Vaccine Research Center. Of interest are vaccines for:~        -  Newly identified infectious diseases such as SARS.~        -  Infectious diseases of concern as possible bioweapons, such as smallpox and Ebola virus~        -  Emerging infectious diseases that are more widespread geographically than in the past,~          such as West Nile virus~        -  For preventing diseases such as tuberculosis and malaria.~      Healthy normal volunteers between 18 and 70 years of age may be eligible for this protocol.~     Screening begins about 1 to 6 months before the start of the vaccine study. Participants will~     have a physical examination and health history, including questions about sexual activity and~     drug use. Over the course of the screening visits, participants will be asked to give urine~     and blood samples to test for various infections and other medical problems. Women capable of~     getting pregnant will be given a pregnancy test. Women who are pregnant or breastfeeding will~     not be enrolled in the study.~      At the end of the screening, participants will be informed about which vaccines are currently~     being tested in clinical trials for which they may be eligible. Once participants enroll in a~     vaccine study, their participation in the screening protocol ends.~   "
267189|NCT00068913|"~     Patients with the MELAS syndrome experience devastating mental impairment. This study will~     evaluate the effectiveness of the drug dichloroacetate (DCA) to reduce the symptoms of MELAS.~   "
267191|NCT00068861|"~     Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women.~     The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair,~     acne, and infertility. This study will test a combination of medications in women with PCOS~     to determine which works best to overcome infertility.~   "
267192|NCT00068848|"~     Women who choose to take birth control pills are currently instructed to begin taking the~     pills at the end of a menstrual cycle. This creates a window of time between when the woman~     is given the pills and when she begins taking them. Some women fail to begin taking the~     pills, placing them at increased risk of pregnancy. This study will evaluate a new approach~     to beginning birth control pills. Women will take the first pill in the doctor’s office~     rather than waiting until the next menstrual cycle.~   "
267193|NCT00068835|"~     Dyslexia is a common reading disorder. Specialized instructional programs can improve reading~     ability in children with dyslexia. This study will use functional magnetic resonance imaging~     (fMRI) to examine changes in the brains of children who have taken part in these programs.~   "
267194|NCT00068822|"~     Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the~     spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of~     fractures due to osteoporosis.~   "
267195|NCT00068809|"~     This study will determine if taking anti-HIV drugs 4 days a week will control HIV-1 viral~     replication in patients who have already had at least 6 months of documented viral~     suppression with full-time treatment. If this strategy is shown to be safe in this study, a~     larger study will be undertaken to determine if the strategy can decrease overall drug~     exposure and help young people adjust more easily to a chronic medication schedule.~   "
267196|NCT00068783|"~     This phase II trial is studying how well imatinib mesylate works in treating patients with~     metastatic or unresectable Merkel cell cancer. Imatinib mesylate may stop the growth of tumor~     cells by blocking the enzymes necessary for tumor cell growth~   "
267197|NCT00068770|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth. It is not yet known whether the effectiveness of celecoxib in treating~     glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and~     undergoing radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are~     receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed~     glioblastoma multiforme.~   "
267198|NCT00068757|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Lonafarnib may stop the growth of~     tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such~     as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing~     substances to them without harming normal cells. Combining lonafarnib and trastuzumab with~     paclitaxel may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when~     given together with trastuzumab and paclitaxel in treating patients with~     HER2/neu-overexpressing stage IIIB, stage IIIC, or stage IV breast cancer.~   "
267199|NCT00068744|"~     RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether~     radiation therapy and mitomycin are more effective when combined with fluorouracil or with~     cisplatin in treating anal cancer .~      PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and~     mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and~     cisplatin in treating patients with locally advanced anal cancer.~   "
267200|NCT00068731|"~     RATIONALE: Lycopene, a substance found in tomatoes, may lower prostate-specific antigen (PSA)~     levels and slow or prevent the development of prostate cancer.~      PURPOSE: Phase II trial to study the effectiveness of lycopene in treating patients who have~     asymptomatic metastatic prostate cancer and a rising PSA level.~   "
267201|NCT00068718|"~     This phase I/II trial studies the side effects of donor lymphocyte infusion and to see how~     well it works in treating patients with persistent, relapsed (disease that has returned), or~     progressing cancer after donor hematopoietic cell transplantation. White blood cells from~     donors may be able to kill cancer cells in patients with cancer that has come back~     (recurrent) after a donor hematopoietic cell transplant.~   "
267202|NCT00068692|"~     This randomized phase III trial is comparing the effectiveness of three adjuvant combination~     chemotherapy regimens in treating patients who are receiving radiation therapy and~     fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs~     used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. It is not yet known which adjuvant~     combination chemotherapy regimen is more effective in treating patients who are receiving~     radiation therapy and fluorouracil either before or after surgery for rectal cancer~   "
267203|NCT00068666|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, use different ways to stop tumor~     cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Combining temozolomide with radiation therapy may make the tumor cells~     more sensitive to radiation therapy and kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation~     therapy works in treating patients with stage IV malignant melanoma with measurable and~     unresectable cancer limited to the central nervous system.~   "
267204|NCT00068653|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the~     tumor. Combining gefitinib with celecoxib may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in~     treating patients who have non-small cell lung cancer that is refractory to platinum-based~     chemotherapy (such as cisplatin or carboplatin).~   "
267205|NCT00068614|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women~     who have breast cancer.~   "
267206|NCT00068601|"~     RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether~     ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women~     receiving chemotherapy for breast cancer.~      PURPOSE: This randomized phase III trial is studying how well giving goserelin together with~     chemotherapy works compared with chemotherapy alone in preventing early menopause in women~     with stage I, stage II, or stage IIIA breast cancer.~   "
267207|NCT00068588|"~     This phase II trial is studying how well giving GTI-2040 together with capecitabine works in~     treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as~     capecitabine, work in different ways to stop tumor cells from dividing so they stop growing~     or die. GTI-2040 may help capecitabine kill more tumor cells by making them more sensitive to~     the drug~   "
267208|NCT00068575|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways~     to stop tumor cells from dividing so they stop growing or die. Biological therapies such as~     interferon alfa may interfere with the growth of the tumor cells and slow the growth of~     cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining~     chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and~     interferon alfa together with radiation therapy works in treating patients who have undergone~     surgery for stage I, stage II, or stage III pancreatic cancer.~   "
267209|NCT00068549|"~     This phase I trial is studying the side effects and best dose of gemcitabine when given~     together with radiation therapy and cisplatin in treating patients with cervical cancer that~     has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor~     cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more~     sensitive to radiation therapy and may kill more tumor cells.~   "
267210|NCT00068523|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the~     body's normal cells. Ultraviolet-B light therapy given before and after allogeneic stem cell~     transplantation may help prevent this from happening.~      PURPOSE: Clinical trial to study the effectiveness of combining ultraviolet-B light therapy~     with allogeneic stem cell transplantation in treating patients who have hematologic~     malignancies.~   "
267211|NCT00068510|"~     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make~     the body build an immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with malignant glioma.~   "
267212|NCT00068497|"~     This phase I trial is studying the side effects of gefitinib in treating patients with~     metastatic or unresectable head and neck cancer or non-small cell lung cancer. Gefitinib may~     stop the growth of cancer cells by blocking the enzymes necessary for their growth~   "
267213|NCT00068484|"~     Drugs used in chemotherapy such as topotecan use different ways to stop tumor cells from~     dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by~     blocking the enzymes necessary for tumor cell growth. Combining topotecan with bortezomib may~     kill more tumor cells. This phase I trial is studying the side effects and best dose of~     topotecan and bortezomib when given together in treating patients with metastatic or~     unresectable cancer~   "
267214|NCT00068471|"~     RATIONALE: Anidulafungin may be effective in preventing fungal infections in~     immunocompromised children who have neutropenia.~      PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how~     well it works in preventing fungal infections in immunocompromised children with neutropenia~     caused by chemotherapy or aplastic anemia.~   "
267215|NCT00068458|"~     RATIONALE: A home-based exercise and/or diet program may improve the quality of life of~     breast cancer patients by preventing an increase in body fat and weight and a loss of lean~     body tissue.~      PURPOSE: This randomized phase II trial is studying the effectiveness of three home-based~     diet and/or exercise programs in preventing weight gain and loss of muscle tissue in women~     who are receiving chemotherapy for stage I, stage II, or stage IIIA breast cancer.~   "
267216|NCT00068445|"~     RATIONALE: Lamotrigine may be effective in reducing pain, numbness, tingling, and other~     symptoms of peripheral neuropathy. It is not yet known whether lamotrigine is effective in~     treating peripheral neuropathy caused by chemotherapy.~      PURPOSE: This randomized phase III trial is studying how well lamotrigine works in reducing~     pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy~     in patients with cancer.~   "
267217|NCT00068432|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor~     cells from dividing so they stop growing or die. Celecoxib may stop the growth of pancreatic~     cancer by stopping blood flow to the tumor and blocking the enzymes necessary for tumor cell~     growth. Combining gemcitabine with celecoxib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with celecoxib~     works in treating patients with metastatic pancreatic cancer.~   "
267218|NCT00068419|"~     This phase II trial is studying how well giving sulindac together with tamoxifen works in~     treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by~     blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may~     fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more~     cancer cells.~   "
267219|NCT00068406|"~     This phase II trial is studying how well giving radiation therapy together with cisplatin~     followed by surgery works in treating patients with locally advanced cancer of the vulva.~     Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor~     so it can be removed during surgery.~   "
267220|NCT00068393|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different~     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one~     drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving doxorubicin together with~     gemcitabine works in treating patients with locally recurrent or metastatic unresectable~     renal cell carcinoma (kidney cancer).~   "
267222|NCT00068367|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth.~      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with~     unresectable or metastatic malignant peripheral nerve sheath tumor.~   "
267223|NCT00068341|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways~     to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as~     trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances~     to them without harming normal cells. It is not yet known whether docetaxel and carboplatin~     are more effective with or without trastuzumab in treating breast cancer.~      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with~     carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone~     before surgery in treating women with locally advanced breast cancer.~   "
267224|NCT00068328|"~     RATIONALE: Studying how older women make treatment decisions and how these decisions affect~     the outcome of treatment may help doctors plan more effective treatments and improve patient~     quality of life.~      PURPOSE: This clinical trial is studying how a patient's treatment preferences and decisions~     about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast~     cancer.~   "
267225|NCT00068315|"~     This phase I trial is studying the side effects and best dose of bortezomib when given~     together with fludarabine with or without rituximab in treating patients with relapsed or~     refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Bortezomib may~     stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.~     Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells~     from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can~     block cancer growth in different ways. Some block the ability of cancer cells to grow and~     spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Giving bortezomib together with fludarabine with or without rituximab may kill more~     cancer cells.~   "
267226|NCT00068302|"~     RATIONALE: Drugs used in chemotherapy such as sirolimus use different ways to stop cancer~     cells from dividing so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of sirolimus in~     treating young patients with relapsed or refractory acute leukemia or non-Hodgkin's lymphoma.~   "
267227|NCT00068289|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth.~      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who~     have recurrent or refractory extensive-stage small cell lung cancer that was previously~     treated with platinum-based chemotherapy (such as cisplatin, carboplatin, or oxaliplatin).~   "
267228|NCT00068276|"~     RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood~     counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome.~      PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients~     with myelodysplastic syndrome.~   "
267229|NCT00068263|"~     RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation~     directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation~     therapy in treating women who have undergone lumpectomy and axillary node dissection for~     stage I or stage II breast cancer.~   "
267230|NCT00068250|"~     RATIONALE: Drugs used in chemotherapy such as methotrexate and temozolomide use different~     ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies~     such as rituximab can locate cancer cells and either kill them or deliver cancer-killing~     substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to~     damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation~     therapy may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide~     when given together with methotrexate and rituximab followed by radiation therapy and to see~     how well they work in treating patients with primary central nervous system lymphoma.~   "
267231|NCT00068237|"~     RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may~     protect the gland from side effects of radiation therapy and may prevent xerostomia (dry~     mouth).~      PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing~     xerostomia in patients who are undergoing radiation therapy for head and neck cancer.~   "
267232|NCT00068211|"~     This is a Phase II, non-randomized, open label study of ILX651 in patients with inoperable~     locally advanced or metastatic melanoma. Approximately 60 patients will be enrolled in this~     study that is expected to last 18 months. All patients will be treated with ILX651~     administered IV daily for 5 consecutive days once every 21 days. The primary objective of~     this study is to determine the overall response rate for all patients who are treated with~     ILX651. The secondary objectives are to determine the progression free survival at 18 weeks,~     duration of response, time to tumor progression, survival, safety/tolerability of ILX651 and~     to evaluate the pharmacokinetic profile.~   "
267233|NCT00068224|"~     This study will evaluate patients ciliopathies. People with ciliopathies develop fibrocystic~     disease of the kidneys and liver, retinal degeneration, obesity, structural and functional~     defects of the central nervous system and the eyes, abnormal bone growth, abnormal sidedness~     of internal organs and polydactyly. The goal of the study is to better understand the medical~     complications of these disorders and identify characteristics that can help in the design of~     new treatments.~   "
267234|NCT00068198|"~     The purpose of this study is to attempt to identify the immune response of healthy adults to~     an investigational dilution of the Dryvax smallpox vaccine. In addition, we will try to~     determine whether certain genetic characteristics influence the size of the sore around the~     vaccination site, and use blood samples from subjects in the study to make a new form of~     antibody that could be given to people with vaccine side effects.~   "
267235|NCT00068185|"~     Black cohosh is a natural supplement that has been used to treat and prevent menopausal~     symptoms. Remifemin is a standardized form of black cohosh. The purpose of this study is to~     determine the levels of components of black cohosh obtained in the blood of healthy women~     taking Remifemin.~   "
267236|NCT00068172|"~     The purpose of this study is to determine whether PI-88 is safe and effective in the~     treatment of advanced melanoma.~   "
267237|NCT00068133|"~     The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared~     with placebo, administered bilaterally to the lower extremities, in subjects with~     intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT)~     for subjects receiving VLTS-589 compared with subjects receiving placebo.~   "
267238|NCT00025207|"~     Phase II trial to study the effectiveness of gefitinib in treating patients who have~     malignant mesothelioma. Biological therapies such as gefitinib may interfere with the growth~     of the tumor cells and slow the growth of malignant mesothelioma~   "
267239|NCT00021268|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of tocladesine in treating patients who~     have recurrent or progressive metastatic colorectal cancer.~   "
267240|NCT00020904|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating women who have~     stage IV or recurrent metastatic breast cancer.~   "
267241|NCT00068159|"~     This study will examine the effect of iron buildup in the hearts of patients with hereditary~     hemochromatosis (HH), a genetic disease that causes the body to accumulate excess amounts of~     iron. The excess iron can damage the heart, liver, pancreas, skin, and joints. Generally,~     early treatment with phlebotomy (periodic removal of a unit of blood), and in some cases~     chelation (using a drug to remove iron from the body) slows down organ damage in HH patients.~     This study will try to elucidate the effect of iron buildup in the heart and determine if~     phlebotomy and chelation help keep the heart healthy.~      Patients with HH and healthy volunteers 21 years of age and older may be eligible for this~     study. (Normal volunteers will provide normal values of heart function that will be used to~     verify abnormalities detected in HH patients.) Patients must have a gene abnormality of Hfe~     gene Cys282Try homozygote. They may or may not be receiving treatment for HH and they must~     have no heart symptoms or serious organ damage due to HH. Candidates will be screened with a~     medical history and physical examination, blood tests, electrocardiogram (EKG), Holter EKG~     (24-hour EKG monitoring, see description below), and chest x-ray.~      Participants will undergo the following tests and procedures over 2 to 5 days:~        -  Exercise test: The participant exercises on a treadmill while wearing a mouthpiece,~          which is used to measure how much oxygen is used. Electrodes placed on the chest and~          arms monitor the heartbeat during the test.~        -  Echocardiography: This ultrasound test uses sound waves to take pictures. A small probe~          is held against the chest to allow a technician to take pictures of the heart and assess~          its function. A drug called Optison may be injected in an arm vein if needed to enhance~          the ultrasound images.~        -  Exercise stress echocardiography: The participant exercises on a stationary bike while~          heart function is measured with an echocardiogram, EKG, and blood pressure cuff.~        -  24-hour Holter EKG: The participant wears a small machine that records heart rhythm~          continuously for 24 hours. The recorder is connected by cables to electrodes placed on~          the chest.~        -  Magnetic resonance imaging: This test uses a magnetic field and radio waves to obtain~          detailed images of the heart and blood vessels. The participant lies flat on a table~          that slides inside the scanner, which is a large hollow tube.~      All tests are performed once in normal volunteers and in patients who have received standard~     treatment for HH. Untreated patients repeat the tests 6 months after beginning phlebotomy or~     chelation. Additional time points for these tests might be added if further evaluation is~     needed.~   "
267242|NCT00068146|"~     This study will evaluate the usefulness of FDG-PET scanning in distinguishing autoimmune~     lymphoproliferative syndrome (ALPS) from lymphoma. Lymphoma is cancer of the lymph system.~     ALPS is a condition involving persistent enlargement of the lymph glands, spleen, or liver,~     and a range of other problems relating to blood cell counts and abnormal immune activity, in~     which the immune system attacks healthy tissues. People with ALPS particularly those with an~     abnormal Fas gene also have an increased risk of developing lymphoma. The Fas gene codes for~     a protein that causes immune cells called lymphocytes to die when they are no longer needed.~      FDG-PET is a new nuclear imaging test that is very effective in detecting lymphoma. It is~     important to identify these cancers as quickly as possible, since some are very curable when~     caught early. Since ALPS and lymphoma share several common characteristics, a reliable,~     non-invasive method of distinguishing the two, such as FDG-PET might offer, is crucial.~     FDG-PET uses a radioactive sugar molecule to produce images that show the metabolic activity~     of tissues. Because cancer cells grow and divide more rapidly than normal cells, they~     metabolize more sugar for fuel. This increased activity identifies them as cancer in FDG-PET~     scanning. For this procedure, the subject is injected with the sugar molecule and lies in a~     doughnut-shaped machine (PET camera) for the imaging.~      Adults and children 10 years old or older with ALPS, with or without lymphoma, may be~     eligible for this study. Candidates will be screened with a physical examination, blood~     tests, and computed tomography (CT) scan.~      Participants will have an FDG-PET scan and a DEXA scan. The DEXA scan measures fat and~     non-fat tissue and is used help interpret the FDG-PET results. For this test, the subject~     lies on a table while a fast X-ray is taken from head to toe.~      Patients who develop signs or symptoms suggesting the development or recurrence of lymphoma~     (such as further enlargement of lymph glands, unexplained fever or weight loss, or abnormal~     scans) may undergo a tissue biopsy. For this procedure, a small piece of lymph or other~     tissue is surgically removed for examination under the microscope. In addition, patients who~     develop these symptoms may be asked to undergo additional FDG-PET scans up to two a year in~     patients without lymphoma, and as many as needed in patients with lymphoma to evaluate their~     response to treatment and guide future therapy.~   "
267243|NCT00068120|"~     This project is the clinical project of a Specialized Center of Research (SCOR) proposal~     which is designed to further our understanding of urinary tract infection (UTI) in women.~     Acute uncomplicated urinary tract infections (UTIs) occur in an estimated 7-11 million women~     each year, and the annual costs of caring for these women are thought to approach $1.6~     billion. Approximately 20-30% of women suffer from frequent recurrent infections. UTIs in~     young women result in substantial symptoms, time lost from work, and medical costs. An~     improved understanding of the mechanisms underlying UTIs could result in new approaches to~     their prevention and reduced numbers of women with infections and the amount of antibiotics~     use.~      In this project we seek a better understanding of the causes of UTI. Most experts believe~     that vaginal colonization with UTI-causing bacteria from the rectal flora precedes~     colonization of the urethra (the tube from the bladder for urination) and bladder and~     subsequent UTI, but the relationships between these events has not been established.~     Moreover, recent information from studies in mice strongly suggest that persistent bladder~     infection follows an initial bladder infection.~      In this project, we will prospectively follow a large group of women with recurrent UTI to~     determine: 1) the relationships in time between vaginal colonization with a UTI-causing~     bacteriuria, asymptomatic bacteriuria (bacteria in the bladder but without any UTI symptoms)~     and symptomatic UTI, and 2) the presence of persistent bacteria in the bladder following the~     symptomatic UTI at entry into the study and whether such bacteria are related to later UTIs~     that are caused by the same bacteria that caused the UTI at entry into the study. We will~     thus be able to determine the relative importance of vaginal colonization vs. persistent~     infection of the bladder as the origin of the bacteria causing recurrent UTI.~      UTI-causing bacteria cultured from women with symptomatic UTI and asymptomatic bacteriuria~     will undergo studies by Dr. Scott Hultgren's group at Washington University in Project 1 to~     identify unique genes that may help us understand why some bacteria cause symptoms and others~     do not. The effect of bacteria causing UTI in these women on host response will also be~     determined by studies by Dr. Jeff Gordon's laboratory at Washington University in Project 3.~      A better understanding of the molecular and epidemiologic basis of UTI is critical in~     developing the best possible prevention and management strategies.~   "
267244|NCT00068094|"~     The purpose of this study is to determine whether probiotics, bacteria that may improve liver~     health, can effectively treat a chronic condition in diabetics that increases fat in the~     liver.~   "
267245|NCT00068081|"~     The purpose of the study is to assess the efficacy, safety and tolerability of NGX 4010~     applied for 60 minutes for the treatment of PHN.~   "
267246|NCT00017043|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who~     have metastatic stomach cancer previously treated with chemotherapy.~   "
267247|NCT00016939|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who~     have unresectable or metastatic kidney cancer.~   "
267248|NCT00016874|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining 3-AP, cisplatin, and~     paclitaxel in treating patients who have advanced or metastatic cancer.~   "
267249|NCT00016341|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy~     using tamoxifen and megestrol may fight endometrial cancer by blocking the absorption of~     estrogen. It is not yet known whether chemotherapy is more effective than hormone therapy in~     treating endometrial cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with that of hormone therapy in treating patients who have recurrent, stage III, or stage IV~     endometrial cancer.~   "
267250|NCT00068107|"~     This study will determine the safety and effectiveness of increasing Replagal infusions in~     certain patients with Fabry disease. Replagal is a genetically engineered form of~     Alpha-galactosidase A, an enzyme that normally breaks down a fatty substance called~     globotriaosylceramide (Gb3). In patients with Fabry disease, Alpha-galactosidase A does not~     function properly and, therefore, Gb3 builds up, causing problems with the kidneys, heart,~     nerves, and blood vessels.~      Patients with Fabry disease who are participating in NIH protocol 00-N-0185 or 02-N-0220 may~     be eligible for this study. This includes patients who are currently taking Replagal but~     whose kidney function continues to worsen, or patients who have certain test results that are~     much improved after Replagal infusion.~      Participants will receive Replagal infusions (0.2 mg/kg body weight) through a vein once a~     week (as opposed to the previous dosage of once every 2 weeks) for up to 2 years. The first~     infusion, and some others, are given at the NIH Clinical Center, but most are administered by~     the patient's local doctor. Vital signs are measured before, immediately after, and 1 hour~     after each infusion.~      Baseline evaluations are done on an inpatient basis at the NIH Clinical Center over a 1-week~     period before and after the first Replagal infusion and at 6-month intervals during the~     study. Tests include a check of vital signs (temperature, respiratory rate, pulse rate, and~     blood pressure); weight measurement; physical and neurological examinations; routine blood~     and urine tests; 24-hour urine collection; electrocardiogram; and review of treatment side~     effects. In addition, the following tests are done:~        -  Quantitative sensory testing: This is a non-invasive test to measure the ability to~          sense warm, cold and vibration in the hand and foot.~        -  QSART: This test measures the amount of sweat in a particular area of skin that did not~          sweat enough. A small amount of a medicine called acetylcholine is put on the skin and~          made to enter the skin using a very small electric current.~        -  Doppler skin blood flow: This test measures blood flow to the blood vessels of the skin.~          A machine takes pictures of blood flow in the skin of the forearm using a laser beam.~          Pictures are taken before and during application of medicines that cause blood vessels~          to dilate. Acetylcholine is used on one forearm and nitroprusside is used on the other.~          The medication is made to enter the skin using a small el...~   "
267251|NCT00068068|"~     The purpose of this study is to determine whether the Litx platform is safe and effective in~     the treatment of liver metastasis arising from colorectal cancer. Litx is a next-generation~     photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by~     light from the light-emitting diode (LED)-based light infusion device, inserted directly into~     the tumor through the skin prior to treatment.~   "
267252|NCT00068055|"~     This study will look at the safety and effectiveness of an experimental medication containing~     antibodies (Omr-IgG-am™) in people with West Nile Virus (WNV) who already have brain and/or~     spinal cord inflammation or who are at high risk of developing these problems because they~     have weak immune systems. WNV can cause problems such as headaches, fever, muscle weakness,~     coma, and death. Study investigators believe people who are not able to fight infection well~     may be at risk for developing neurologic problems (having to do with the brain, spinal cord,~     nerves, and muscles) if they get WNV infection. Up to 110 subjects, 18 years or older, will~     participate for about 3 months and will receive either Omr-IgG-am™, Polygam® S/D, or placebo~     given through a small tube placed in a blood vessel in the arm. Hospitalization, up to 5~     additional study visits, blood sample collection, MRI pictures of the brain and spinal cord,~     and neurological, muscle, and heart activity tests are also required.~   "
267253|NCT00068042|"~     The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin~     LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.~   "
267254|NCT00067899|"~     The purpose of this study is to determine if oxidative stress derived from cigarette smoking~     increases vitamin E requirements. The study will also assess the role of vitamin C in~     modulating vitamin E requirements. Vitamin E requirements will be assessed by measuring~     vitamin E in plasma as well as by measuring the excreted vitamin E metabolite in the urine.~   "
267255|NCT00068029|"~     The purpose of this study is to compare the safety and tolerability of combination therapy~     with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.~   "
267256|NCT00067990|"~     Chronic allograft nephropathy continues to be a major cause of kidney transplant loss and~     return to dialysis. Treatment options are limited and the course of the disease tends to be~     progressive. This trial is designed to prevent a major mediator of this process, namely the~     expansion of the cortical interstitial compartment of the kidney where most of the scarring~     occurs. The drug being studied, Losartan, has proven efficacious in a number of kidney~     diseases.~   "
267257|NCT00067964|"~     The projects funded by this grant, primarily focus on environmental factors that promote~     weight-gain in the general human population, and how to modify these factors, to prevent~     further weight-gain in the future. In the coming years, the researchers at the University of~     Colorado-HSC hope to gain an understanding as to how small changes in diet and physical~     activity can be achieved and sustained to prevent weight-gain.~   "
267258|NCT00067951|"~     The purpose of this research study is to determine if a new investigational diabetes drug is~     safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c~     or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test~     or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood~     over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood~     after an 8 hour fast.~   "
267259|NCT00067938|"~     Bipolar study of tolerability, clinical response and patient satisfaction~   "
267288|NCT00067769|"~     Encopresis, also known as fecal incontinence, is the voluntary or involuntary passage of~     stools causing soiling of clothes by a child over 4 years of age. The purpose of this study~     is to evaluate an Internet intervention for the treatment of encopresis.~   "
267289|NCT00005804|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give~     higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating~     patients who have hematologic cancer.~   "
267260|NCT00068003|"~     Background:~      The NCI Surgery Branch has developed experimental therapies that involve taking white blood~     cells from patients' tumor or from their blood, growing them in the laboratory in large~     numbers, and then giving the cells back to the patient.~      Objective:~      This study will collect white blood cells from normal volunteers and white blood cells and/or~     tumor cells, from patients who have been screened for and are eligible for a NCI Surgery~     Branch treatment protocol. The cells collected from normal volunteers will be used as growth~     factors for the cells during the period of laboratory growth. The cells and/or tumor from~     patients will be used to make the cell treatment product.~      Eligibility:~      Patients must be eligible for a NCI Surgery Branch Treatment Protocol~      Normal Volunteers must meet the criteria for blood donation~      Design~      Both patients and normal Volunteers will undergo apheresis. Patients will then undergo~     further testing as required by the treatment protocol.~      There is no required follow up for normal volunteers.~   "
267261|NCT00067925|"~     The Incorporating More Physical Activity and Calcium in Teens (IMPACT) study was a~     behaviorally-based middle school nutrition and physical activity program for the prevention~     of osteoporosis. The goal of IMPACT was to increase calcium intake and physical activity to~     help build bone mass in girls.~   "
267262|NCT00016276|"~     Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery,~     and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have~     stage IIIA, stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs,~     such as dexrazoxane, may protect normal cells from the side effects of chemotherapy.~     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses~     high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy combined with~     surgery and radiation therapy is more effective with or without dexrazoxane and trastuzumab~     in treating breast cancer~   "
267263|NCT00010036|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining carboplatin with irinotecan~     in treating patients who have glioblastoma multiforme.~   "
267264|NCT00008359|"~     RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or~     controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or~     peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or~     amphotericin B liposomal is more effective for treating these side effects.~      PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with~     that of amphotericin B liposomal in treating patients who have persistent fever and~     neutropenia after receiving anticancer therapy.~   "
267265|NCT00008086|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Calcitriol may help solid tumor cells develop into normal cells.~     Combining calcitriol with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with carboplatin in~     treating patients who have advanced solid tumors.~   "
267266|NCT00006346|"~     RATIONALE: Transcendental meditation may be an effective way to decrease the amount of stress~     in older women with breast cancer. It is not yet known if transcendental meditation is more~     effective than basic breast cancer education in improving quality of life.~      PURPOSE: This randomized clinical trialstudies stress reduction in improvingquality of life~     in older women with stage II, stage III, or stage IV breast cancer.~   "
267267|NCT00067912|"~     How duloxetine compares to a medication currently available for the treatment of depression~     in the treatment of patients with major depressive disorder.~      The safety of duloxetine and any side effects that might be associated with it.~   "
267268|NCT00006265|"~     RATIONALE: Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from~     dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may~     kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with~     high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid~     leukemia.~   "
267269|NCT00006254|"~     RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune~     system and stop cancer cells from growing.~      PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have~     advanced solid tumors.~   "
267270|NCT00006223|"~     RATIONALE: Drugs such as flt3L may stimulate a person's immune system and help kill cancer~     cells. It is not yet known if flt3L is effective in treating acute myeloid leukemia.~      PURPOSE: Randomized phase III trial to determine the effectiveness of flt3L in treating~     patients who have acute myeloid leukemia that is in remission.~   "
267271|NCT00006103|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if the effectiveness of irinotecan combined~     with fluorouracil in treating colorectal cancer varies depending on the patient's racial~     background.~      PURPOSE: Phase III trial to study the effectiveness of irinotecan combined with fluorouracil~     in treating patients from different racial backgrounds who have colorectal cancer that is~     advanced, recurrent, metastatic or has not responded to treatment with fluorouracil.~   "
267272|NCT00006096|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known if radiation therapy combined with chemotherapy kills more tumor~     cells than radiation therapy alone in treating cancer of the vulva.~      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy with~     or without cisplatin in treating patients who have stage I, stage II, or stage III cancer of~     the vulva.~   "
267321|NCT00067431|"~     The purpose of this study is to compare the safety and efficacy of two concentration ranges~     of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of~     partial seizures, with or without secondary generalization, in children 3-10 years.~   "
267273|NCT00067886|"~     Matrix metalloproteinases (MMPs) are a family of protein-degrading enzymes that are involved~     in the breakdown and remodeling of many tissues and organs. Abnormal activity of these~     enzymes has been implicated in many disease processes including rheumatoid arthritis, dental~     disease and metastatic cancer. Recent studies also suggest that elevations in blood sugar may~     abnormally effect MMP enzyme activity. Decreased activity of some of these MMP enzymes may be~     a partial cause of the abnormal enlargement of the kidney (renal hypertrophy) seen at the~     start of diabetic kidney disease (nephropathy). Preliminary clinical data from our laboratory~     confirm that children with newly diagnosed type 1 diabetes mellitus (DM) have lower blood~     levels of some of these enzymes at the time of very high blood sugar readings. However, these~     enzyme levels become normal again as blood sugar levels improve with insulin treatment. In~     the present study, we propose to investigate the hypothesis that MMPs are involved in the~     cause of diabetic kidney disease by measuring concentrations of specific MMPs and some~     related proteins in the blood and urine of patients with type 1 DM who are between the ages~     of 14-40 years. We will enroll some patients who are recently diagnosed with diabetes, some~     who have had diabetes for several years, but without signs of kidney disease, and some with~     long-term diabetes and various degrees of kidney disease. Continuous Subcutaneous Glucose~     Monitoring, conducted for 3-4 days, will also be provided as a part of this study, to~     determine how different levels of blood sugar control might relate to different levels of MMP~     enzyme activity in the blood. We anticipate that this study will help to establish a link~     between abnormal MMP activity and the cause of nephropathy in type 1 DM, allowing scientists~     to design better therapies for the prevention and treatment of diabetes-related kidney~     problems.~   "
267274|NCT00067873|"~     Overweight premenopausal Black and White women are randomized to either diet-only,~     diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or~     without the aerobic or resistance exercise training, will be provided throughout the 18~     months of study. Major outcomes will include measures of perceived and physiologic difficulty~     of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise~     tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure~     (all derived from doubly labeled water). The results will provide insight into the~     effectiveness of, and the mechanisms by which, different types of exercise training can~     improve physical fitness, spontaneous engagement in physical activities of daily living and,~     in turn, weight-loss maintenance.~   "
267275|NCT00067860|"~     This is a double-blind randomized controlled study on the clinical and metabolic effects and~     underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth~     hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition.~     Clinical endpoints include ability to wean patients from parenteral feeding, metabolic~     endpoints include gut nutrient absorptive function and molecular endpoints include expression~     of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month~     study is performed, in part, in the General Clinical Research Center for inpatient stays and~     outpatient visits.~   "
267276|NCT00067847|"~     Four California school districts will be randomized to early implementation of California's~     SB 19 Pupil Nutrition Act or to business as usual. Over 5000 4th, 5th and 7th graders will be~     evaluated at baseline, 4-month, and 16-month follow-up in order to determine if the SB 19~     nutrition and physical activity policies have had an impact on students' risk of excess body~     weight. The impact of early implementation of SB 19 on academic achievement will also be~     assessed.~   "
267277|NCT00067834|"~     This study will determine the usefulness of pulsing electromagnetic field (PEMF) technology~     to reverse or reduce the bone loss (osteopenia) that occurs in the forearm after fracture or~     surgery.~   "
267278|NCT00006019|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer~     cells.~      PURPOSE: Phase II trial to study the effectiveness of phenylbutyrate plus azacitidine in~     treating patients who have acute myeloid leukemia, myelodysplasia, non-Hodgkin's lymphoma,~     multiple myeloma, non-small cell lung cancer, or prostate cancer.~   "
267279|NCT00006002|"~     RATIONALE: SU5416 may stop the growth of prostate cancer by stopping blood flow to the tumor.~     Dexamethasone may be effective in slowing the growth of prostate cancer cells. It is not yet~     known whether SU5416 or dexamethasone is more effective in treating progressive prostate~     cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of SU5416 with that of~     dexamethasone in treating patients who have progressive prostate cancer that has not~     responded to hormone therapy.~   "
267280|NCT00005887|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     RSR13 may make tumor cells more sensitive to radiation therapy.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the~     brain with or without RSR13 in treating patients who have brain metastases.~   "
267281|NCT00005886|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.~      PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers~     of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast~     cancer.~   "
267282|NCT00005857|"~     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to compare the effectiveness of trastuzumab alone and in combination~     with docetaxel in treating patients who have metastatic prostate cancer that is refractory to~     hormone therapy.~   "
267283|NCT00005845|"~     This phase I trial studies the side effects and best dose of tipifarnib in treating patients~     with myelodysplastic syndromes. Tipifarnib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~   "
267284|NCT00067821|"~     This study in children and young adults will compare two types of imaging, positron emission~     tomography ([(18)F]-DG PET) and proton magnetic resonance spectroscopy ((1)H-MRSI), to~     determine activity of a brain tumor or abnormal tissue in the brain following treatment for a~     brain tumor. Children with brain tumors are generally followed with magnetic resonance~     imaging (MRI) scans to evaluate response to treatment. However, because MRI only provides~     information on the structure of the brain, it may difficult to tell if an abnormal finding is~     due to tumor, swelling, scar tissue, or dead tissue. (1)H-MRSI and [(18)F]-DG PET, on the~     other hand, provide information on the metabolic activity of brain lesions. These two methods~     will be compared and evaluated for their ability to provide important additional information~     on childhood brain tumors.~      Patients between 1 and 21 years of age with a brain tumor or brain tissue abnormality~     following treatment for a brain tumor may be eligible for this study. Candidates will be~     screened with a medical history and physical examination, pregnancy test in women who are~     able to become pregnant, and a blood test for glucose.~      Participants will undergo the following procedures:~      (1)H-MRSI - This test is similar to MRI and is done in the same scanning machine. In MRI,~     scans of the brain are obtained by applying a strong magnetic field and then collecting the~     signals released from water after the magnetic field is changed. Pictures of the brain are~     then obtained by computer analysis of these signals. In (1)H-MRSI, the computer blocks the~     signal from water to get information on brain chemicals that can indicate whether an~     abnormality is tumor or dead tissue. Both MRI and MRI and (1)H-MRSI are done in this study.~      For these tests, the child lies on a stretcher that moves into the scanner - a narrow metal~     cylinder with a strong magnetic field. The child's head is placed in a headrest to prevent~     movement during the scan. He or she will hear loud thumping noises caused by the electrical~     switching of the magnetic field. A contrast agent is given through an intravenous (IV)~     catheter (plastic tube placed in an arm vein) or through a central line if one is in place.~     The contrast material brightens the images to provide a clearer picture of abnormalities.~     Children who have difficulty holding still or being in a scanning machine are given~     medications by an anesthesiologist to make them sleep through the procedure. Children who are~     awake during the procedure can communicate with the MRI technician at all times and ask to be~     removed from the scanner at any time. The MRI and (1)H-MRSI take 1-1/2 to 2 hours to~     complete.~      [(18)F]-DG PET - For this test, [(18)F]-DG (a radioactive form of glucose) is injected into~     the patient's arm vein through a catheter, followed by the PET scan, similar to a very open~     MRI scan without the noise. The PET scan tells how active the patient's tumor is by tracking~     the radioactive glucose. All cells use glucose, but cells with increased metabolism, such as~     cancer cells, use more glucose than normal cells. After the glucose injection, the patient~     lies quietly in a darkened room for 30 minutes, after which he or she is asked to urinate to~     help reduce the dose of radiation to the bladder. Then, the scan begins. When the scan is~     finished (after about 1 hour), the child is asked to urinate again and then every 3 to 4~     hours for the rest of the day.~      Patients remain in the study for 2 years unless they withdraw, become pregnant, or require~     sedation but can no longer use an anesthetic. MRI and 1H-MRSI scans may be repeated every few~     months during the study period, if necessary. Only one PET scan is done each year.~   "
267285|NCT00067808|"~     The goal of this clinical research study is to learn if decitabine (given at 3 different~     doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments~     will also be studied.~   "
267286|NCT00067795|"~     Some people's immune systems are able to control HIV infection without anti-HIV drugs. Other~     people with HIV must take drugs to prevent the virus from destroying their immune systems.~     There are many different laboratory tests that measure immune function in people with HIV.~     This study will compare some of these tests to see if they consistently measure differences~     between people who control the HIV without anti-HIV drugs and those who must take drugs.~   "
267287|NCT00067782|"~     The purpose of this clinical research study is to learn if atazanavir is associated with~     serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for~     their previously administered protease inhibitor.~   "
267290|NCT00005090|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It~     is not yet known if combination chemotherapy is more effective with or without peripheral~     stem cell transplantation in treating Hodgkin's Disease.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without peripheral stem cell transplantation in treating men who have stage III or~     stage IV Hodgkin's disease.~   "
267291|NCT00067756|"~     The purpose of this study is to find out whether 4-PBA will increase the level of AAT in~     persons with AAT deficiency whether or not they have liver disease.~   "
267292|NCT00067743|"~     This is a multicenter, open-label study in adult subjects with Type 1 Complex Regional Pain~     Syndrome. Subjects diagnosed with unilateral Type 1 CRPS will be enrolled sequentially to~     receive CC-5013 10 mg/day orally. For each subject the study consists of two phases:~     Pre-treatment phase(1 wk) and treatment phase (12 wks)~   "
267293|NCT00067730|"~     The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood~     cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for~     bone marrow transplant (BMT).~   "
267294|NCT00067717|"~     This trial examines the impact of patients' knowledge of an experienced distant healer's~     efforts to heal them on measures of wound healing, psychosocial functioning, and~     physiological symptoms after plastic surgery.~   "
267295|NCT00067704|"~     The specific objective of this study are to examine whether or not a treatment aimed at~     emotional disclosure may have beneficial psychological, health and immune effects for HIV~     infected individuals. The goal of the current study is to test the efficacy of emotional~     disclosure through writing in patients with HIV infection. We will compare emotional~     disclosure through writing about traumatic experiences (experimental intervention) to a~     control intervention (writing about emotionally neutral topics). [Note that HIV RNA viral~     load, CD4 T cells, urinary cortisol, health related dysfunction, psychological distress, and~     medication adherence are the 6 primary outcome variables.~   "
267296|NCT00067691|"~     The purpose of this study is to determine whether acupuncture is effective in relieving~     shortness of breath among breast and lung cancer patients.~   "
267297|NCT00067678|"~     Diabetic nephropathy is a frequent cause of end-stage renal disease. Reduction of dietary~     protein has been used to slow down renal disease progression, but patients are often~     unwilling to make these dietary changes. Other research suggests that changing the quality of~     dietary protein may be as effective as reducing the total amount of ingested protein. This~     study hopes to show that soy protein, a plant protein relatively high in essential amino~     acids and with high nutritional value, maye be beneficial to Type I diabetic patients with~     incipient renal disease.~   "
267298|NCT00067665|"~     How high blood pressure in hemodialysis patients should be diagnosed and treated using~     medications or without medications is the purpose of this study.~   "
267299|NCT00067652|"~     The focus of this study is the development of a school-based multimedia product for the~     prevention of body dissatisfaction and unhealthy weight control behaviors in adolescents. The~     program is being designed for early adolescents, age 12-14, and will include information on~     maturation, healthy eating and exercise, skill building modules and media literacy awareness.~   "
267300|NCT00067639|"~     In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for~     autologous transplantation. One of the cited advantages of this procedure is the avoidance of~     bone marrow harvest, which frequently requires general anesthesia. Other advantages include~     faster neutrophil and platelet engraftment times, faster immune recovery, decrease in the~     amount of tumor contamination and technical ability to obtain stem cells from patients~     previously considered unharvestable because of marrow fibrosis or because of prior~     radiotherapy to the pelvis. Filgrastim has emerged as the preferred cytokine for stem cell~     mobilization based on its safety profile and the positive experience in granulocyte donors~     however, the number of circulating CD34+ cells does not occur until the third day after~     starting filgrastim injections. Pegfilgrastim stimulates the production and maturation of~     neutrophil precursors and enhances the functions of mature neutrophils in the same manner as~     filgrastim. Data form normal volunteers and in studies of patients with cancer have shown~     prolonged serum levels of the cytokine, with self-regulation of pegfilgrastim levels as a~     function of the neutrophil count. This confers a therapeutic advantage in clinical settings~     by allowing a less frequent dosing.~   "
267301|NCT00067626|"~     The purpose of this study is to investigate the effects of Chromium on glucose tolerance and~     endothelial function in people at risk for type II diabetes.~   "
267302|NCT00067613|"~     This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking~     -- comparing care practices between different NICUs to see which practices prevent~     bronchopulmonary dysplasia (BPD) -- and quality improvement would change practices and~     improve rates of survival without BPD in inborn neonates with birth weights of <1250 grams.~     Benchmarking is a method involving detailed comparisons of processes between similar~     organizations. For this study, three NRN centers with the lowest rates of BPD have been~     identified as Benchmark centers. During a 6-month pre-intervention period, details of care~     practices and management style at these centers were carefully assessed. Based on practices~     at these Benchmarking sites, we developed a quality improvement program. For this study, 14~     other NRN sites were randomized to either implement the benchmarking intervention~     (intervention sites) or continue with their usual care practices (control sites). After the~     1-year intervention period, we compared changes in the rate of survival without BPD at 36~     weeks corrected age between the intervention and control sites.~   "
267303|NCT00067600|"~     Osteoporosis affects nearly half of all American women over age 50. During the teenage years,~     girls can increase bone growth to decrease their risk of osteoporosis later in life. This~     study will test whether girls can change their food intake and physical activity patterns in~     ways that will increase their bone growth during the mid-teen years.~   "
267322|NCT00067405|"~     The purpose of this study is to determine if intravenous micronutrient therapy (IVMT) is~     effective in the treatment of fibromyalgia, as assessed by validated functional and pain~     measures.~   "
267304|NCT00067587|"~     Though anti-HIV drugs can dramatically improve the health of people with HIV, some people~     taking these drugs develop serious long term effects in their metabolism. These effects~     include problems with bones, increased levels of blood sugar and lipids, and changes in body~     fat distribution. The purpose of this study is to see how many young women are experiencing~     these problems and how severe the problems are. This kind of study is the first step in~     determining how best to treat these problems.~   "
267305|NCT00067574|"~     This study will attempt to stimulate the immune system in HIV infected adolescents and young~     adults so that it can better control the HIV infection. When anti-HIV drugs are stopped for a~     period of time, the virus grows back. This may stimulate the immune system, which may then~     be more effective in controlling the virus.~   "
267306|NCT00067561|"~     The purpose of this study is to compare the safety and effectiveness of different doses of an~     investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome~     (IBS) who have failed conventional therapy.~   "
267307|NCT00067548|"~     This non-randomized, open-label, outpatient clinical trial is designed to assess the safety~     and efficacy of daily orally administered EKB-569 in subjects with advanced non-small cell~     lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based~     therapy either given concurrently or as separate regimens.~      The primary objective of the study is to assess the clinical activity of EKB-569 administered~     orally as a second-line or later stage treatment in subjects with advanced non-small cell~     lung cancer. Secondary objectives include:~        -  To further evaluate the safety of EKB-569~        -  To explore additional clinical activity parameters~        -  To explore subject survival~        -  To evaluate the pharmacokinetics of EKB-569~        -  To assess subject reported outcomes~      EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569~     daily as long as they do not have progressive disease and are tolerating treatment.~   "
267308|NCT00067535|"~     The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR~     102681~   "
267309|NCT00067522|"~     Prevention of unplanned pregnancies among HIV infected couples decreases the rate of~     maternal-child virus transmission and the number of children orphaned when parents die of~     AIDS. This study will evaluate two programs for reducing the number of unplanned pregnancies~     among HIV infected couples in Zambia.~   "
267310|NCT00067509|"~     Emergency contraception is a method of birth control that can be used up to three days after~     sexual intercourse. Emergency contraceptive pills (ECPs) can be given to a woman before she~     needs them (advance provision) or when she needs them (emergency provision). This study will~     compare these two methods of providing ECPs.~   "
267311|NCT00067470|"~     The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance~     endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in~     the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.~   "
267312|NCT00004256|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     sargramostim may protect normal cells from the side effects of radiation therapy.~      PURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in~     preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.~   "
267313|NCT00004233|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs such as triacetyluridine may protect normal~     cells from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and~     leucovorin in treating patients who have unresectable, locally advanced, or metastatic cancer~     of the esophagus or stomach.~   "
267314|NCT00004221|"~     Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem~     cell transplantation in treating patients who have undergone surgery for stage III ovarian~     cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~   "
267315|NCT00004125|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which regimen of chemotherapy is more effective~     for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of~     combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that~     has spread to the lymph nodes.~   "
267316|NCT00004032|"~     Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in~     patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer~     cells may make the body build an immune response to and kill their tumor cells. Combining~     vaccine therapy with interferon gamma may be a more effective treatment for epithelial~     ovarian cancer~   "
267317|NCT00067496|"~     This study, conducted at the Walter Reed Army Medical Center, the National Rehabilitation~     Hospital, and the National Institutes of Health, will examine whether the drug Modafinil can~     decrease fatigue in patients with post-polio syndrome. Many people who have had polio develop~     weakness and severe fatigue several years after their recovery from the acute disease.~     Modafinil is approved by the Food and Drug Administration to improve wakefulness in patients~     with narcolepsy (disease in which patients have excessive daytime sleepiness) and has been~     used to treat patients with fatigue related to other medical conditions, such as multiple~     sclerosis. This study will compare the effects of two doses of Modafinil and of a placebo (a~     pill with no active ingredient) on fatigue in patients with post-polio syndrome.~      Patients who develop fatigue, weakness, muscle pain or atrophy, and functional loss at least~     15 years after recovering from polio and whose symptoms cannot be attributed to another cause~     may be eligible for this study. Candidates will be screened with a medical history, physical~     and neurological examinations, fatigue rating scales, electrocardiogram, blood and urine~     tests, drowsiness and depression evaluations, and an electroymogram (EMG) to diagnose nerve~     or muscle problems. For the EMG, electrodes (small metal discs) are taped to the skin and a~     needle is inserted into a muscle to record the electrical activity.~      Candidates will also undergo a sleep study to exclude abnormal sleep patterns as the cause of~     the fatigue. For this study, patients stay overnight at the NIH hospital. Electrodes are~     placed on the throat, on a finger, and on the chest (for an electrocardiogram), and a~     respiratory belt is placed around the chest-abdomen area. During sleep (from 10:30 p.m. to 6~     a.m.), brain waves, eye and leg movements, muscle tone, respiration, and heart rate are~     recorded. Beginning at 8 a.m. the following morning, the patient takes 20-minute naps to~     measure the level of daytime sleepiness, using a recording technique similar to that of the~     all-night study. When five naps are completed, the sleep study ends. Candidates may also~     undergo a lumbar puncture (spinal tap) to check for certain chemicals in the spinal fluid~     that might be related to fatigue and to look for possible causes of post-polio syndrome. This~     procedure is optional. For the lumbar puncture, a local anesthetic is given and a needle is~     inserted in the space between the bones in the lower back where the cerebrospinal fluid~     circulates below the spinal cord. A small amount of fluid is collected through the needle.~      Patients enrolled in the study will complete a sleep diary during the entire study period.~     They will be randomly assigned to one of two treatment groups-Modafinil or placebo-for 6~     weeks, followed by a 2-week washout period with no medication, and then a crossover phase, in~     which patients who took Modafinil for the first 6 weeks now take placebo, and those who took~     placebo now take Modafinil.~      At the first study visit, patients will be given a supply of study medication and have blood~     drawn. They will take one pill twice a day during both study phases. In both study phases,~     evaluations will be done 3 and 6 weeks after starting the medication. The evaluations include~     filling out the same forms completed at the screening visit, a review of drug side effects,~     and a review of medical problems since the last study visit. At the 6-week visit, blood is~     also drawn.~   "
267318|NCT00067483|"~     This study will use a new dynamic light scattering device (DLS), developed jointly by NASA~     and the NEI, to study pre-senile cataracts (cataracts that develop in patients 55 years old~     or less). Cataract is a clouding of the lens that interferes with the passage of light to the~     retinal, impairing visual acuity. DLS uses a low intensity laser light (similar to that used~     in supermarket checkouts) to measures lens cloudiness. It detects changes in the human lens~     at the earliest molecular stages of cataract development, when anti-cataract treatment would~     be most effective in reversing, delaying or preventing cataract formation.~      Patients 55 years of age or younger with cataract may be eligible for this study. Candidates~     will be screened with the following tests and procedures:~        -  Medical history and physical examination.~        -  Eye examination, including measurement of visual acuity (vision chart) and eye pressure;~          examination of pupils and eye movements; dilation of the pupils for examination of the~          lens and the back of the eye (retina).~        -  Cataract photography using a camera with a bright flash to assess the status of the~          cataract and evaluate future changes.~        -  Blood drawing if necessary for clinical care.~      Participants will have a standard eye examination, as described above, plus DLS testing. For~     this procedure, the patient sits in front of the DLS device, with the chin placed on a chin~     rest. He or she fixes on a yellow-green target in the center of the camera lens. When the eye~     is properly aligned, the measurement is taken and the reddish light on the side of the camera~     lens turns on for 5 seconds. Measurements are taken on three layers of the lens. The~     procedure takes less than 30 minutes.~      Participants will be followed at the NIH clinic once a month for up to 1 year to follow~     progression of the cataract. The visits will include a repeat of some of the exams listed~     above.~   "
267319|NCT00067457|"~     The purpose of this study is to compare the safety and effectiveness of as needed versus~     fixed dosing of an investigational medication for women with severe diarrhea-predominant~     Irritable Bowel Syndrome (IBS) who have failed conventional therapy.~   "
267320|NCT00067444|"~     Major Depressive Disorder (MDD) Study in Elderly Outpatients~   "
267323|NCT00067392|"~     The purpose of this study is to determine the difference in success when placing implants~     immediately into an extraction site compared to delaying the implant placement until the~     extraction site has healed. In addition, the level of bone around the implants will be~     compared to determine if one method leads to better results over time.~   "
267324|NCT00067340|"~     The purpose of this study is to conduct a community based, randomized control trial to~     determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will~     reduce the vertical transmission of caries between Alaska Native mothers to their infants.~   "
267325|NCT00004004|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of procarbazine in treating patients who~     have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme~     following treatment with radiation therapy.~   "
267326|NCT00003931|"~     RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect~     acute myeloid leukemia and determine the extent of disease.~      PURPOSE: Diagnostic study to try to detect changes in the genes of patients who have acute~     myeloid leukemia.~   "
267327|NCT00003890|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have~     advanced solid tumors.~   "
267328|NCT00003736|"~     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective~     treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to~     detect breast cancer.~      PURPOSE: Screening and diagnostic trial to study the effectiveness of MRI scans in women who~     are at high risk for developing breast cancer.~   "
267329|NCT00003464|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating adults with~     newly diagnosed primary malignant glioblastoma multiforme.~   "
267330|NCT00067418|"~     This study will use light scattering spectroscopy (LSS) to analyze brain tissue removed from~     patients during brain surgery to determine if this new technology can be used to~     differentiate between normal and cancerous cells. LSS focuses light on cells or tissues, and~     the way that light is reflected back from the tissues provides information about the size of~     cells and the density of the cell nuclei (the part of the cell that contains the genes).~      Patients between 18 and 75 years of age with a known or suspected brain tumor and patients~     with temporal lobe epilepsy that does not respond to medication may be eligible for this~     study. (Examination of tissue from patients with epilepsy will allow comparison of tumor and~     non-tumor brain cells.) All patients must require surgery to treat their condition.~      Participants will be admitted to the Clinical Center for 3 to 10 days for physical and~     neurological examinations, blood and urine tests, and other tests needed to prepare for~     surgery. They will then undergo surgery. A small amount of tissue removed during surgery for~     pathological review will be collected for use in this study.~      Half of the tissue will be examined using LSS to help determine the size of the cell and its~     nucleus. Studies will be done to measure how many of the cells are actively dividing and~     which proteins are expressed more often in tumor cells compared with normal cells. This~     information may shed light on how tumor cells are different from normal cells.~      Participants may be contacted for up to 3 years to follow their health status.~   "
267331|NCT00067379|"~     The primary objective of this study is to examine the usefulness of early orthodontic~     intervention as a means of increasing access to orthodontic services for children of~     low-income families.~   "
267332|NCT00067366|"~     Temporomandibular Disorder (TMD) is a widespread chronic pain condition. Successful~     psychosocial treatments for TMD have been developed, but the mechanisms by which these~     treatments achieve their effects are not well known. The goal of this project is to evaluate~     the possible mechanisms responsible for treatment gains in TMD treatment.~   "
267333|NCT00067353|"~     The aim of this study is to determine whether an annual application of three (3) fluoride~     varnish doses over two weeks is at least as effective in reducing cavities as the current~     semi-annual application.~   "
267334|NCT00067327|"~     The purpose of this study is to determine whether raising low levels of the natural~     antioxidant uric acid by the administration of a precursor, inosine, has any therapeutic~     effect on the progression of Relapsing Remitting Multiple Sclerosis (RRMS) and secondary~     progressive Multiple Sclerosis (MS).~   "
267335|NCT00067314|"~     This international study will study how metastatic breast cancer responds to the~     investigational drug treatment, what are the side effects of the investigational drug when~     given to women with metastatic breast cancer and how often do these side effects occur. The~     study will also analyze how fast investigational drug and its breakdown products are cleared~     from the blood in these patients.~   "
267336|NCT00067301|"~     The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up~     response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major~     Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA.~   "
267337|NCT00067288|"~     We have developed an 8-week Meaning-Centered Group Psychotherapy designed to help patients~     with advanced cancer sustain or enhance a sense of meaning, peace and purpose despite the~     limitations of their cancer illness. This project's overall aim is to explore the feasibility~     and efficacy of this new and unique psychotherapy intervention for advanced cancer patients~     in enhancing psychological and spiritual well-being and quality of life by comparing it with~     a standard supportive group psychotherapy.~   "
267338|NCT00067262|"~     The purpose of this study is to determine the safety and effectiveness of Depakote ER~     (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar~     disorder, manic or mixed type in children and adolescents ages 10-17 years.~   "
267339|NCT00067249|"~     The purpose of this study is to examine socio-cultural factors of women’s use of~     complementary and alternative medicine (CAM). The effects of socioeconomic status, social~     networks and acculturation on CAM use will be assessed among white, African-, Mexican-, and~     Chinese-American women.~   "
267340|NCT00067275|"~     This study will examine how dopamine, a brain chemical, affects motor training. Taken by~     mouth, dopamine can enhance motor training, especially during rehabilitation after brain~     damage. The study will also examine whether Sinemet, a drug containing a precursor of~     dopamine, can improve motor training.~      Healthy normal volunteers and stroke patients between 18 and 80 years of age may be eligible~     for this study. Healthy volunteers must be right-handed. Stroke patients must have had a~     stroke that caused weakness in one hand, from which they have recovered enough to be able to~     move the thumb in different directions. Participants will have up to three study sessions, as~     follows:~      Prestudy 1 (MRI, TMS with motor training)~        -  Session 1: Magnetic resonance imaging (MRI) of the brain. This procedure uses a strong~          magnetic field and radio waves to show structural and chemical changes in tissues.~          During the scan, the patient lies on a table in a narrow cylinder containing a magnetic~          field. He or she can communicate with the staff administering the test at all times.~        -  Session 2: Transcranial magnetic stimulation (TMS) - The subject sits in a comfortable~          chair with the right forearm held still at the side and the head held still by an~          aluminum frame. A magnetic coil is placed over the head, and a small probe is attached~          to the thumb to measure thumb movement. Magnetic pulses are occasionally delivered over~          the scalp, likely inducing a mild thumb movement. After this test, the subject takes a~          tablet of either Sinemet or placebo (a look-alike pill with no active ingredient). Fifty~          minutes after taking the pill, the subject undergoes motor training that involves~          performing brisk thumb movements at a rate of 1 movement per second. At the end of the~          training, TMS is repeated.~        -  Session 3: Identical to session 2, except subjects who took Sinemet in session 2 now~          take placebo, and vice versa.~      Prestudy 2 (MRI, PET without motor training, no TMS)~        -  Session 1: MRI of the brain if the subject has not had one within the last 12 months.~        -  Session 2: Positron emission tomography (PET) scanning - This procedure provides~          information on brain chemistry and function. First, the subject is given either Sinemet~          or placebo. The subject lies on a bed in a doughnut-shaped machine with a custom-molded~          plastic mask placed over the face and head to support the head and hold it still during~          the scanning. A catheter (plastic tube) is placed in each arm-one to inject~          [11C]raclopride-a radioactive substance that competes with dopamine for binding in~          certain parts of the brain and can be detected by the PET scanner-and one to draw blood~          samples for measuring the level of Sinemet in the blood.~        -  Session 3: Identical to session 2, except subjects who took Sinemet in session 2 now~          take placebo, and vice versa.~      Main Study (MRI, TMS, PET with motor training)~        -  Session 1: MRI of the brain, if one has not been done within the last 12 months.~        -  Session 2: TMS, followed by administration of Sinemet or placebo and PET scanning with~          motor training. The subject lies quietly during the first half of the PET session and~          performs brisk thumb movements during the second half. After completing the PET scan,~          the subject undergoes TMS again.~        -  Session 3: Identical to session 2, except subjects who took Sinemet in session 2 now~          take placebo, and vice versa.~   "
267341|NCT00067236|"~     The main purpose of the study is to test whether a possible new drug (called PG-116800) can~     prevent some of the damage to heart muscle in patients who have had a heart attack. The study~     will also supply information regarding possible uses of this compound in cardiovascular~     disease.~   "
267342|NCT00067223|"~     Recent studies suggest that when patients learn a new motor movement, it may cause a change~     in the way the nerves act in the area of the brain that controls that movement. This change~     is called use-dependent plasticity.~      The purpose of this study is to determine the direction and extent of the changes that take~     place in the brain areas that control movement in the untrained finger after the training of~     the opposite finger. The study outcomes may help researchers to develop rehabilitation~     strategies for people who have suffered brain injuries.~      Eighteen healthy adults age 18 years or older will be enrolled in this study. Participants~     will undergo a clinical exam and then come back to the Clinical Center three times for~     sessions that will last approximately 2 hours each. For each session, participants' forearms~     will be immobilized and a small electronic device will be attached to each index finger so~     that researchers can measure their movements. Participants will be asked to move either index~     finger and to observe and concentrate on its movement. Investigators will perform~     transcranial magnetic stimulation (TMS) before and after these motor exercises. For TMS, a~     wire coil is held over the scalp and a brief electrical current passes through the coil,~     creating a magnetic pulse that electrically stimulates the brain.~   "
267343|NCT00067210|"~     Doctors use cooling of the brain to help stop seizures. This procedure is usually~     accomplished through surgery. Cooling of the face and scalp may also cool the brain, avoiding~     the need for surgery.~      The purpose of this study is to assess a head-neck cooling device that the patient can wear.~     Researchers will determine whether the device can change the frequency of seizures in people~     with epilepsy.~      Study participants must be 21 years of age or older and must experience seizures that occur~     once a week on a regular basis. Participants will be asked to keep a detailed seizure diary~     for a 12-week period before the date of the first cooling session. For each of the four~     cooling sessions, participants will be admitted to the hospital overnight. They will undergo~     a physical and neurological exam and an EEG (electroencephalogram). They will also swallow a~     temperature-sensor pill. Participants will have one 60-minute cooling session once a week for~     4 weeks. Investigators will paste temperature-sensing electrodes on the scalp, forearm,~     abdomen, and leg. Participants will then be fitted with the cooling unit and the session will~     begin.~   "
267344|NCT00067197|"~     No universally successful therapy exists that promotes recovery of motor function after a~     stroke, the main cause of long-term disability among adults.~      The purpose of this study is to develop strategies to improve recovery of lost motor~     function. It will combine motor skills training with a brain-stimulating technique called~     transcranial direct current stimulation (tDCS).~      Healthy adult volunteers and adult stroke patients will be enrolled in this study.~     Participants will come to NIH for a clinical and neurological exam, and, if necessary, an MRI~     [magnetic resonance imaging] examination. Participants will return for 4 sessions; each~     lasting approximately 3 hours. The first will be a practice session during which participants~     will become familiar with the motor skills required of them in this study, such as performing~     finger movements on a keyboard, pinching, tapping, making wrist movements, and lifting small~     items. In sessions 2 and 3, participants will perform the motor skills they practiced in~     session 1 while receiving tDCS. During session 4, they will receive tDCS only, with no~     performance of motor skills.~      During tDCS, investigators will place electrodes with a gel on participants' heads and pass~     the tDCS current between these two electrodes. tDCS is a painless procedure.~      Participants will receive up to $420 in compensation for their involvement in this study.~   "
267345|NCT00067184|"~     The purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours~     after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.~   "
267346|NCT00067171|"~     The purpose of this study is to test a feasibility study of a telephone enhancement procedure~     (TELE) to improve participation in continuing care activities.~   "
267347|NCT00067158|"~     The purpose of this study is to look at how feasible it is to incorporate a state-of-the-art~     smoking cessation treatment program into community substance abuse treatment programs and its~     impact on substance abuse and cigarette smoking.~   "
267348|NCT00067145|"~     Many overweight patients are able to lose weight successfully, but then regain their weight.~     The purpose of this study is to develop and test the efficacy of 2 interventions to prevent~     weight regain in individuals who have recently lost weight. The two interventions being~     tested are a face-to-face group maintenance program and an Internet intervention. These~     interventions will be compared to a no-contact control group that receives quarterly~     newsletters. The primary outcome measure is weight regain from baseline to 18-months.~   "
267349|NCT00067132|"~     Of the four million trauma cases each year that will require hospitalization, 200,000 will be~     classified as severe trauma. During the hospital stay, malnutrition is a major complication~     in about 50% of the patient population. The result is muscle wasting which is a major risk~     factor for increased morbidity and mortality. In this study we postulate that supplementation~     with beta-hydroxy-beta-methylbutyrate (HMB), arginine and glutamine (HMB/Arg/Gln)or HMB alone~     to these severely traumatized patients can stem the loss of muscle tissue and whole body~     nitrogen and in turn decrease morbidity and mortality. This hypothesis is based on two recent~     studies showing the same nutritional mixture of HMB/Arg/Gln can reverse the muscle wasting~     associated with AIDS and Cancer. The hypermetabolic state seen in AIDS and cancer have a~     similar multifactorial etiology as seen in trauma. There is an increase in the mobilization~     of fat and muscle, increased or normal metabolic rate, increased protein breakdown, and an~     increased or normal glucose turnover. In addition, HMB alone has been shown to reduce~     nitrogen loss, decrease muscle proteolysis and muscle damage within the first 48 hours to~     three weeks after initiating supplementation during a strenuous exercise program. Male and~     female patients (n=100) will be recruited at the time of admittance to the Trauma ICU with an~     ISS of greater than 18. Patients who meet the inclusion/exclusion criteria will be randomized~     to receive either 1) standard tube feed plus HMB/Arg/Gln, 2) standard tube feed plus HMB~     alone, or 3)standard tube feed (control) in a double-blinded fashion. Clinical outcomes~     measures will be assessed through out the hospital stay and on an outpatient basis at weeks 4~     and 12. Muscle proteolysis and nitrogen economy will be evaluated on daily basis while in the~     hospital and after 4 weeks on an out patient basis. If as expected, Phase I results confirm~     the effectiveness of the nutrient mixture in trauma patients, expanded multicenter studies~     will be proposed in Phase II.~   "
267350|NCT00067119|"~     The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs~     primary unassisted patency in newly created arteriovenous grafts. This record previously~     included information for both the GRAFT and FISTULA trials.~   "
267351|NCT00067106|"~     HIV is found in both the blood and the genital tract. This study will compare the levels and~     types of HIV found in the blood with the levels and types of HIV found in the female genital~     tract.~      Study hypotheses: 1) In the presence of antiretroviral therapy, viral replication within the~     female genital tract may lead to the development of drug resistance that is different from~     that of virus in the blood plasma. 2) Antiretroviral drug levels in the female genital tract~     may often be lower than in the blood plasma and differences in drug exposure may be~     associated with differences in virus replication and selection of resistant HIV variants~     during drug failure. 3) HIV can be recovered in vitro from cells in the female genital tract~     during successful therapy, and it may be genetically different from the HIV variants~     recovered from the blood cell latent reservoir on the same visit.~   "
267352|NCT00067093|"~     Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study.~     The purpose of the study is to compare the safety and effectiveness of a new injectable~     anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the~     standard way of treating deep vein thrombosis. The standard treatment includes injections or~     infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin)~     for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or~     acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with~     either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight~     heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to~     both patients and their doctors.~   "
267353|NCT00067080|"~     The purpose of this study is to determine if the new orally active iron chelator, ICL670, is~     as safe as deferoxamine in preventing accumulation of iron in the body while a patient is~     undergoing repeated blood transfusions.~   "
267354|NCT00067041|"~     Approximately 30 patients will be enrolled in this 12-week study designed to assess the~     effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass~     grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted~     in the hospital and on an out-patient basis. The study will be conducted at multiple centers.~   "
267355|NCT00067028|"~     The goal of this clinical research study is to find the best safe dose for 2 different drug~     combinations. For this purpose, participants will either receive the combination of~     clofarabine plus idarubicin or clofarabine plus idarubicin and ara-C. Once the best safe dose~     for these drug combinations are found, the next goal is to compare the drug combinations~     clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment~     of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic~     Myeloid Leukemia who have relapsed following their initial therapy. In the current extension~     part of the study, you will only receive the clofarabine/idarubicin/ara-C combination. The~     activity and the safety of this treatment will be studied.~   "
267356|NCT00003433|"~     RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build~     an immune response to kill their tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white~     blood cells in treating patients with resected liver metastases from colon cancer.~   "
267357|NCT00003323|"~     RATIONALE: Male hormones can stimulate the growth of prostate cancer cells. Hormone therapy~     using flutamide and finasteride may fight prostate cancer by reducing the production of male~     hormones.~      PURPOSE: Phase II trial to study the effectiveness of flutamide and finasteride in treating~     prostate cancer patients with high PSA levels who were previously treated with radiation~     therapy or radical prostatectomy.~   "
267358|NCT00003210|"~     Phase II trial to study the effectiveness of interleukin-12 in treating patients with~     previously treated non-Hodgkin's lymphoma or Hodgkin's disease. Interleukin-12 may kill tumor~     cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to~     kill lymphoma cells.~   "
267359|NCT00003114|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with~     lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients with stage IIB,~     stage III, or stage IV AIDS-related Hodgkin's disease.~   "
267360|NCT00003006|"~     RATIONALE: Detecting very early metastases in bone marrow and/or lymph nodes may help doctors~     plan better treatment for non-small cell lung cancer.~      PURPOSE: Clinical trial to detect the presence of metastatic cancer in patients with stage I~     non-small cell lung cancer that has not been previously treated.~   "
267361|NCT00067067|"~     Recent studies suggest that cells in the bone marrow-endothelial precursor cells (EPCs)-can~     provide a blood supply to cancerous tumors.~      The purpose of this study is to collect brain tumor and blood samples to look for these EPCs~     in the samples and analyze the growth signals that may help blood vessels to grow in tumors.~     Researchers will study the following in the samples: 1) the number of blood vessels in the~     tumor; 2) the levels of growth factors in the tumor and blood; 3) the levels of circulating~     EPCs in the blood; and 4) the changes in the genes and proteins in the blood and tumor that~     influence growth factor levels.~      Participants will be 18 years of age or older and have evidence of a brain tumor that~     requires surgery. From this surgery they will donate blood and tumor samples. Participants~     will have follow-up visits 4 to 8 weeks after surgery, then at 3-month intervals for~     two-and-one-half years, then at 6-month intervals thereafter. At these visits, participants~     will undergo a physical exam, a brain scan, and blood work.~   "
267377|NCT00066885|"~     This Phase 1/2 clinical trial is a multi-center, open-label study with three main objectives.~     The first (Phase 1A) is to determine the maximum-tolerated dose of DN-101 when administered~     in combination with Taxotere (docetaxel) every three weeks (closed). The second is to~     determine the maximum-tolerated dose of DN-101 when administered weekly in combination with~     Taxotere(docetaxel)devery three weeks (open). The third is to evaluate the safety and~     objective tumor response rate of the combination in NSCLC. DN-101 doses will be escalated at~     three dosing levels. Patients will receive oral DN-101 on day one, followed by intravenous~     docetaxel on day two of a 21-day cycle. Treatment cycles will be repeated at the same dose~     level each 21 days until disease progression or unacceptable toxicity.~   "
271168|NCT00036621|"~     This clinical trial will assess whether BMS-275291 can be administered safely in combination~     with standard adjuvant therapy for early breast cancer and whether plasma concentrations at~     trough exceed a target minimum.~   "
267362|NCT00067054|"~     This study collects specimens from volunteers for use in studies by NIAID's Vaccine Research~     Center. A number of different types of specimens or samples can be collected, including~     blood, urine, body fluids or secretions, skin swabs, or skin biopsies. The samples are used~     for medical research, including the study of HIV, hepatitis, and other diseases; immune~     system responses, such as responses to vaccinations or infections; and for research on~     vaccine development.~      Blood samples may be collected either by ordinary blood drawing (phlebotomy) or by apheresis,~     a procedure for collecting a larger quantity of blood cells or plasma than would be possible~     through simple blood drawing. For this procedure, the subject lies on a recliner or couch.~     Blood is removed through a needle in the vein of one arm and spun in a machine that separates~     out the desired component (plasma or white blood cells). The remainder of the blood is~     returned either through the same needle or through a needle in the other arm. The procedure~     takes about 1 to 3 hours.~      Volunteers who are 18 years of age and older, including participants in other NIH research~     protocols, may be eligible. Individuals who have a condition that the research staff~     considers a reason not to make a sample donation will be excluded from the study.~      Participants may have only one sample collected or may be asked to undergo repetitive sample~     collection procedures, depending upon the requirements of the particular research project for~     which the samples are being collected. Each individual's enrollment is for a 1-year period,~     which can be extended.~   "
267363|NCT00067015|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     therapy in different ways may cause less damage to normal tissue and may improve quality of~     life and help patients live more comfortably. Androgens can stimulate the growth of prostate~     cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the~     production of androgens. It is not yet known whether radiation therapy is more effective with~     or without goserelin and bicalutamide in treating prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation~     therapy with or without bicalutamide and goserelin in treating patients who have prostate~     cancer.~   "
267364|NCT00067002|"~     The goal of this clinical research study is to learn if combining cord blood units to make~     the cells take faster in recipients will help to improve the results of cord blood~     transplants.~   "
267365|NCT00066989|"~     The main objective will be to test the safety of two intravenous infusions of Altastaph, a~     human immunoglobulin product. The study will also test the ability of Altastaph to protect~     against S. aureus infection.~   "
267366|NCT00046878|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. O(6)-benzylguanine may increase the effectiveness of carmustine by~     making tumor cells more sensitive to the drug.~      PURPOSE: Phase II trial to study the effectiveness of combining carmustine with~     O(6)-benzylguanine in treating patients who have newly diagnosed supratentorial glioblastoma~     multiforme.~   "
267367|NCT00002970|"~     Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or~     refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die.~   "
267368|NCT00002621|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating children~     with an HIV-related cancer including leukemia, non-Hodgkin's lymphoma, CNS lymphoma, or other~     solid tumors.~   "
267369|NCT00002548|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy and radiation therapy and kill more~     cancer cells. It is not yet known which treatment regimen is more effective for multiple~     myeloma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan, total-body~     irradiation, and peripheral stem cell transplantation with that of combination chemotherapy~     in treating patients who have previously untreated multiple myeloma.~   "
267370|NCT00002520|"~     RATIONALE: Physician-initiated smoking cessation strategies may be effective in getting~     early-stage cancer patients to quit smoking.~      PURPOSE: Randomized clinical trial to compare the effectiveness of a physician-initiated~     stop-smoking program with the usual care for patients receiving treatment for early-stage~     cancer.~   "
267371|NCT00066976|"~     Some babies have difficulty breathing, sucking, and swallowing at birth. The purpose of this~     study is to determine (before birth) the variables that will predict whether a newborn will~     experience these problems.~      Study participants will be pregnant women with a single fetus who are 18 years or older and~     who are scheduled to receive a standard prenatal ultrasound. Researchers will use the~     ultrasound to observe fetal motions associated with breathing, sucking, and swallowing on~     digital videotape. They will then review these tapes and take measurements that will help~     them document how breathing and swallowing develop.~   "
267372|NCT00066963|"~     The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or~     twice a year with counseling to counseling alone in preventing early childhood caries (ECC)~     (tooth decay in children under the age of five).~   "
267373|NCT00066950|"~     The purpose of this study is to determine whether dental disease patterns and transmissable~     bacteria that are known to cause a severe form of dental decay in young children can be~     reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine~     and fluoride varnish applications, respectively as part of a comprehensive Prevention~     Management Model.~   "
267374|NCT00066937|"~     The purpose of this study is to determine whether the combination of cognitive-behavioral~     treatment and nortriptyline are more effective than each treatment alone in reducing the pain~     and disability associated with TMD.~   "
267375|NCT00066924|"~     The purpose of this study is to determine whether religiosity and spirituality are related to~     immune functioning, as measured by interleukin-6 blood plasma level, among terminally ill~     cancer patients.~   "
267376|NCT00066898|"~     To assess the safety and efficacy of AGI-1067, as compared to placebo, in the treatment of~     vascular inflammation and atherosclerosis by assessing the reduction in cardiovascular~     events.~   "
271169|NCT00036608|"~     The purpose of this clinical research study is to assess the safety and effectiveness of~     switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.~   "
267379|NCT00005027|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating~     patients who have advanced kidney cancer.~   "
267380|NCT00066911|"~     Some voice disorders are caused by uncontrolled muscle actions that affect the larynx or~     voice box.~      The purpose of this study is to understand 1) how the brain controls voice production; 2) how~     changes in sensation within the voice box affect brain control of the voice box; 3) how the~     central nervous system is affected when people have motor or sensory abnormalities that~     affect the voice box; and 4) whether patients with voice disorders differ from people without~     voice disorders in the way the brain controls the voice box. By better understanding these~     concepts, researchers hope to develop improved treatments for patients with voice disorders.~      Forty-five healthy adult volunteers and 90 patients with voice disorders will participate in~     this study. Participants must be between the ages of 20 and 70. The study will involve two~     visits to the Clinical Center. During the first visit, participants will undergo a medical~     history and physical exam. During the second visit, investigators will perform the following~     procedures on study participants: 1) look at the voice box with a nasolaryngoscope, a fine~     tube through the nose; 2) use MRI [magnetic resonance imaging] to record brain activity while~     participants use their voice to speak; 3) changing sensation in the voice box by dripping a~     topical anesthetic onto the vocal folds; and 4) using MRI to again record brain activity~     during speech immediately after applying the topical anesthetic.~      Participants will receive up to $700 in compensation for their involvement in this study.~   "
267381|NCT00066872|"~     RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune~     system and stop cancer cells from growing. It is not yet known if topical imiquimod is more~     effective than surgery in treating basal cell skin cancer.~      PURPOSE: This randomized phase III trial is studying how well topical imiquimod works~     compared to surgery in treating patients with basal cell skin cancer.~   "
267382|NCT00066859|"~     RATIONALE: Antidepressants such as sertraline and the herb hypericum perforatum (St. John's~     wort) may be effective in treating mild to moderate depression. It is not yet known which~     treatment is more effective in improving depression in patients who have cancer.~      PURPOSE: This randomized phase III trial is studying how well sertraline works compared to~     St. John's wort in treating mild to moderate depression in patients with solid tumors.~   "
267383|NCT00066846|"~     RATIONALE: Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary~     for cancer cell growth. Drugs used in chemotherapy such as fluorouracil and leucovorin use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     bevacizumab with fluorouracil and leucovorin may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil~     and leucovorin in treating patients who have locally advanced or metastatic stage IV~     colorectal cancer that has progressed after standard chemotherapy.~   "
267384|NCT00066807|"~     The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women~     with steroid hormone receptor positive early invasive breast cancer who receive ovarian~     function suppression plus either tamoxifen or exemestane for five years. The use of~     chemotherapy was determined by randomization. The method of ovarian function suppression~     (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice~     of tamoxifen or exemestane were determined by the investigator or by randomization in the~     IBCSG 25-02 TEXT trial [recommended option]. The trial was terminated early due to poor~     accrual.~   "
267385|NCT00066794|"~     RATIONALE: Drugs used in chemotherapy, such as cyclosporine, daunorubicin, and cytarabine,~     use different ways to stop cancer cells from dividing so they stop growing or die. Combining~     more than one drug may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving cyclosporine together with~     daunorubicin and cytarabine works in treating older patients with untreated acute myeloid~     leukemia.~   "
267386|NCT00066781|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining more than one drug~     may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan~     works in treating patients with cancer of unknown primary origin.~   "
267387|NCT00066768|"~     This randomized phase I trial is studying the side effects and best dose of suramin when~     given together with either docetaxel or gemcitabine in treating patients with stage IIIB or~     stage IV non-small cell lung cancer that is refractory to platinum chemotherapy (such as~     cisplatin, carboplatin, or oxaliplatin). Drugs used in chemotherapy such as docetaxel and~     gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die.~     Some tumors become resistant to chemotherapy drugs. Combining suramin with either docetaxel~     or gemcitabine may reduce resistance to the drugs and kill more tumor cells.~   "
267388|NCT00066742|"~     This phase II trial is studying how well giving tirapazamine together with cisplatin,~     etoposide, and radiation therapy works in treating patients with limited-stage small cell~     lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Tirapazamine may make the tumor cells more~     sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy~     with tirapazamine may kill more tumor cells.~   "
267389|NCT00066729|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: This phase I trial to studying the side effects of vaccine therapy in treating~     patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.~   "
267390|NCT00066716|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase~     the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.~     Celecoxib may also stop the growth of tumor cells by stopping blood flow to the tumor and/or~     may block the enzymes necessary for their growth. Combining celecoxib with paclitaxel and~     carboplatin before surgery may shrink the tumor so that it can be removed during surgery.~     Giving celecoxib alone after surgery may kill any remaining tumor cells.~      PURPOSE: This phase II trial is studying how well giving celecoxib together with paclitaxel~     and carboplatin works in treating patients who are undergoing surgery for esophageal cancer.~   "
267391|NCT00066703|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of~     estrogen. It is not yet known whether giving triptorelin together with exemestane is more~     effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.~      PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how~     well they work compared to triptorelin and tamoxifen in treating premenopausal women with~     hormone-responsive breast cancer.~   "
267392|NCT00066690|"~     RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function~     suppression combined with hormone therapy using tamoxifen or exemestane may fight breast~     cancer by reducing the production of estrogen. It is not yet known whether suppression of~     ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone~     in preventing the recurrence of hormone-responsive breast cancer.~      PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or~     exemestane to see how well they work compared to tamoxifen alone in treating premenopausal~     women who have undergone surgery for hormone-responsive breast cancer.~   "
267393|NCT00066677|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such~     as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing~     or die. Combining bevacizumab with docetaxel may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well~     they work compared to bevacizumab alone in treating patients with metastatic pancreatic~     cancer.~   "
267394|NCT00066664|"~     RATIONALE: The presence of specific serum proteins may allow a doctor to determine if a~     patient has mycosis fungoides/cutaneous T-cell lymphoma.~      PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis~     fungoides/cutaneous T-cell lymphoma.~   "
267395|NCT00066651|"~     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.~     Immunotoxin therapy may be effective in treating advanced solid tumors.~      PURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin therapy~     in treating patients with recurrent unresectable advanced solid tumors.~   "
267396|NCT00066638|"~     Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from~     dividing so they stop growing or die. Phase II trial to study the effectiveness of FR901228~     in treating patients who have relapsed or refractory multiple myeloma~   "
267397|NCT00066625|"~     Phase I trial to study the effect on the body of combining oxaliplatin with bortezomib in~     treating patients who have metastatic or unresectable cancer. Drugs used in chemotherapy such~     as oxaliplatin use different ways to stop cancer cells from dividing so they stop growing or~     die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for~     tumor cell growth. Combining oxaliplatin with bortezomib may kill more cancer cells~   "
267398|NCT00066612|"~     RATIONALE: Drugs used in chemotherapy such as irinotecan use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have recurrent or refractory advanced transitional cell cancer of the urothelium.~   "
267399|NCT00066599|"~     RATIONALE: Voriconazole may be effective in preventing systemic fungal infections following~     chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of voriconazole in preventing systemic~     fungal infections in children who have neutropenia after receiving chemotherapy for leukemia,~     lymphoma, or aplastic anemia or in preparation for bone marrow or stem cell transplantation.~   "
267400|NCT00066586|"~     RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased~     risk of developing breast cancer. Exemestane may be effective in preventing the development~     of breast cancer by decreasing estrogen levels and reducing breast density.~      PURPOSE: Randomized clinical trial to study the effectiveness of exemestane in preventing the~     development of breast cancer by decreasing estrogen levels and reducing breast density in~     postmenopausal women who are at increased risk for breast cancer.~   "
267401|NCT00066573|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy, using~     exemestane or anastrozole, may fight breast cancer by reducing the production of estrogen. It~     is not yet known whether exemestane is more effective than anastrozole in preventing the~     recurrence of breast cancer.~      PURPOSE: This randomized phase III trial is studying exemestane to see how well it works~     compared to anastrozole in preventing cancer recurrence in postmenopausal women who have~     undergone surgery for primary breast cancer.~   "
267402|NCT00066547|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effect of monoclonal antibody therapy on the body and~     its effectiveness in treating women who have locally advanced or metastatic breast cancer~     that was previously treated with combination chemotherapy.~   "
267403|NCT00066508|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary~     for cancer cell growth.~      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who~     have diffuse large B-cell lymphoma that is refractory to previous chemotherapy.~   "
267404|NCT00066482|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effect on the body of combining cyclophosphamide with~     cisplatin, etoposide, and bleomycin in treating children who have newly diagnosed malignant~     germ cell tumors that are not in the brain and gonads.~   "
267405|NCT00066469|"~     RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and~     methylprednisolone use different ways to stop cancer cells from dividing so they stop growing~     or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them~     or deliver cancer-killing substances to them without harming normal cells. Combining~     cyclophosphamide and either prednisone or methylprednisolone with rituximab may be effective~     in treating lymphoproliferative disease following organ transplantation.~      PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide and either~     prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr~     virus-positive lymphoproliferative disease following organ transplantation.~   "
267406|NCT00066456|"~     Phase I trial to study the effectiveness of low-dose radiation therapy to the abdomen~     combined with docetaxel in treating patients who have recurrent or persistent advanced~     ovarian, peritoneal, or fallopian tube cancer. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with~     radiation therapy may kill more tumor cells.~   "
267407|NCT00066443|"~     RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to~     stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such~     as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral~     blood and may help a person's immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel~     with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.~   "
267408|NCT00066430|"~     RATIONALE: Infrared coagulation may be effective in preventing the development of anal cancer~     in patients who have anal neoplasia.~      PURPOSE: Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal~     cancer in HIV-positive patients who have high-grade anal neoplasia.~   "
267409|NCT00066417|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell~     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When the stem cells from a related~     donor, that do not exactly match the patient's blood, are infused into the patient they may~     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets.~      PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in~     treating patients with high-risk leukemia.~   "
267410|NCT00066404|"~     RATIONALE: Using BG00001 to insert the gene for interferon-beta into a person's pleural~     cavity may improve the body's ability to fight cancer.~      PURPOSE: Phase I trial to study the effectiveness of intrapleural BG00001 in treating~     patients who have malignant pleural mesothelioma or malignant pleural effusions.~   "
267411|NCT00066391|"~     RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to~     stop tumor cells from dividing so they stop growing or die. Combining irinotecan with~     cisplatin may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in~     treating patients who have locally advanced or metastatic penile cancer.~   "
267412|NCT00066378|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may~     stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining~     anastrozole with gefitinib may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or~     without gefitinib in treating postmenopausal women who have metastatic or locally recurrent~     breast cancer.~   "
267413|NCT00066365|"~     RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the~     growth of tumor cells and shrink the tumor so that it can be removed during surgery.~     Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective~     treatment for osteosarcoma that has spread to the lung.~      PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating~     patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread~     to the lung.~   "
267414|NCT00066352|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary~     for their growth.~      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with~     advanced or metastatic transitional cell cancer of the bladder, renal pelvis, or ureter.~   "
267415|NCT00066339|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have~     metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase~     inhibitor therapy.~   "
267416|NCT00066326|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes~     necessary for cancer cell growth. Drugs used in chemotherapy such as~     17-N-allylamino-17-demethoxygeldanamycin use different ways to stop cancer cells from~     dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill~     more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     17-N-allylamino-17-demethoxygeldanamycin when given together with imatinib mesylate in~     treating patients with chronic myelogenous leukemia.~   "
267417|NCT00066313|"~     RATIONALE: ZD6474 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. ZD6474 may also stop the growth of small cell lung cancer by blocking blood~     flow to the tumor.~      PURPOSE: This randomized phase II trial is studying how well ZD6474 works compared to placebo~     in treating patients with small cell lung cancer that has responded to previous chemotherapy~     with or without radiation therapy.~   "
267418|NCT00066274|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving the drugs in different combinations may kill more tumor~     cells.~      PURPOSE: This randomized phase II trial is studying combination chemotherapy containing~     irinotecan and oxaliplatin to see how well it works compared to two standard combination~     chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.~   "
267419|NCT00066248|"~     RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in~     children with cancer.~      PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in~     improving appetite and preventing weight loss in children with cachexia caused by cancer or~     cancer treatment.~   "
267420|NCT00066222|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together~     with radiation therapy works in treating patients with limited-stage small cell lung cancer.~   "
267421|NCT00066196|"~     The primary objectives of this study are:~        -  To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic~          melanoma.~        -  To determine the safety of MEDI-522 ± DTIC in this patient population.~   "
267422|NCT00020462|"~     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune~     response to kill tumor cells. Combining vaccine therapy with interleukin-2 may be a more~     effective treatment for follicular lymphoma .~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus interleukin-2 in~     treating patients who have stage III, stage IV, or recurrent follicular lymphoma.~   "
267423|NCT00019721|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining~     vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.~      PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without~     interleukin-2 in treating patients who have metastatic melanoma that has not responded to~     previous therapy.~   "
267424|NCT00019383|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving~     the vaccine with interleukin-2 or sargramostim may help kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without~     adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory~     metastatic melanoma.~   "
267425|NCT00066209|"~     Severe Acute Respiratory Syndrome (SARS) is a newly recognized illness that can be fatal.~      The purpose of this study is to better understand SARS by collecting samples of blood and~     other body fluids of people who have been exposed to SARS or who are suspected to have the~     illness.~      Up to 300 volunteers aged 18 years or older will be enrolled in this study. Participants will~     donate blood samples and, if appropriate, samples of fluid from the lungs, nose, or throat.~     Researchers will test these samples for proteins that control or mediate inflammatory or~     immune responses. The patterns of these proteins will reveal how SARS affects the body and~     the efforts the body makes to fight off the infection.~   "
267426|NCT00066170|"~     This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled,~     parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be~     required to make 5 visits over up to 14 weeks to a participating expert physician~     practitioner for various sleep and narcolepsy evaluations and diaries will also be collected.~     Participants will take assigned medications during the course of the trial. Subjects will~     have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject~     volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness.~     Patients will not incur any personal medical expenses due to participation in this trial. The~     sponsor is covering all visit costs not covered by insurance and there are some funds for~     patient expenses such as travel.~   "
267427|NCT00033722|"~     RATIONALE: Lometrexol may stop or slow the growth of tumor cells by blocking the enzymes~     necessary for tumor cell growth. Folic acid may be effective in preventing or lessening the~     side effects of lometrexol. Combining lometrexol with folic acid may be an effective~     treatment for non-small cell lung cancer.~      PURPOSE: Phase II trial to study the effectiveness of combining lometrexol with folic acid in~     treating patients who have stage IIIB or stage IV non-small cell lung cancer that has been~     previously treated.~   "
267428|NCT00033306|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who~     have metastatic colorectal cancer.~   "
267429|NCT00031811|"~     RATIONALE: Raloxifene and exercise may improve bone health and quality of life in breast~     cancer survivors. Assessing bone health and quality of life may improve the ability to plan~     treatment.~      PURPOSE: Randomized clinical trial to study the effectiveness of raloxifene with or without~     exercise compared with exercise alone in women who have been previously treated for breast~     cancer.~   "
267430|NCT00031785|"~     RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in~     limiting weight loss in patients who are undergoing radiation therapy.~      PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting~     weight loss in patients who are undergoing radiation therapy for lung cancer.~   "
267431|NCT00066183|"~     Phosphorus and phosphate irons play critical roles in bone structure and essential cellular~     functions.~      The purpose of this study is to learn more about the factors and hormones that regulate~     phosphorus in the body by collecting blood and urine samples from patients with disorders of~     phosphate control.~      Both children and adults will be enrolled in this study. Researchers will collect blood and~     urine samples from participants on multiple occasions (2 to 6 times). Some blood specimens~     will be taken after an overnight fast and participants may be asked to collect all their~     urine during a 24-hour period. Researchers will analyze these blood and urine samples to~     better understanding how the body handles phosphorus.~   "
267432|NCT00066157|"~     This is a 15-month study to determine the effectiveness of hormone replacement therapy in~     improving memory and the ability to live independently in postmenopausal women with~     Alzheimer's disease.~   "
267433|NCT00066144|"~     This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the~     efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also~     assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies),~     breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline~     and 1 year.~   "
267434|NCT00066131|"~     The purpose of this study is to determine if non-surgical periodontal (gum) treatment can~     reduce the incidence of preterm birth and low birth weight babies in mothers with~     periodontitis (gum disease).~   "
267435|NCT00066118|"~     The purpose of this study is to determine whether there are detectable health effects of~     low-level mercury exposure (from normal exposure to mercury-containing dental fillings) in~     the known target organs/systems affected by elemental mercury exposure.~   "
267436|NCT00066092|"~     This is a randomized, double-blind, multi-center study to assess the safety and effectiveness~     of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily~     subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation~     in patients with Hodgkin's or non-Hodgkin's lymphoma.~   "
267516|NCT00065247|"~     The Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project is an after-school~     program that includes weight loading physical activity, nutrition and bone health education,~     and calcium-rich snacks. The program is designed to improve bone health in early elementary~     school children.~   "
267437|NCT00066079|"~     The purpose of this study is to compare the effects of in-home, family-administered massage~     and in-home relaxation training on measures of physical status and health care utilization in~     a sample of African American adolescents age 15 years and older and adults with chronic pain~     associated with sickle cell disease who have been randomly assigned to six sessions of either~     family-administered massage or progressive muscle relaxation training.~   "
267438|NCT00066066|"~     The purpose of this study is to determine in current and non-smokers the clinical and~     microbiological effects of 3 therapies: scaling and root planing (SRP) alone; SRP in~     combination with the orally administered antibiotic metronidazole; and SRP with the orally~     administered antibiotics metronidazole and amoxicillin along with the locally delivered~     antibiotic doxycycline at periodontal pockets >= 4 mm.~   "
267439|NCT00066053|"~     The purpose of this study is to determine if treating periodontal infections (gum problems)~     will lead to fewer heart problems in patients at high risk for cardiovascular disease.~   "
267440|NCT00066040|"~     The purpose of this study is to control the levels of bacteria that causes cavities in~     mothers by a combination of treatments that include fluoride and chlorhexidine varnishes and~     xylitol-chewing gum before the appearance of teeth in the mouth of their children. By doing~     that we expect to reduce the acquisition of the bacteria that causes cavities (the mutans~     streptococci) by the children which in turn will reduce the development of cavities.~   "
267441|NCT00066027|"~     The primary purpose of this clinical trial is to determine whether low-dose doxycycline can~     reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and~     not on hormone replacement therapy (i.e., estrogen deficient).~   "
267442|NCT00066014|"~     The purpose of this study is to compare the effectiveness of three variable dental implant~     attachment methodologies in conjunction with lower dental-implant retained/supported complete~     overdenture treatment. These three methods are all presently used by dental practitioners,~     but vary significantly in terms of added treatment cost and complexity. The study tests the~     hypothesis that the least complex and costly method provides an equivalent treatment outcome~     to other more complex and costly methods.~   "
267443|NCT00066001|"~     The purpose of this study is to determine the clinical and microbiological effects of~     systemically administered metronidazole alone or in combination with professional plaque~     removal on periodontally diseased patients.~   "
267444|NCT00065988|"~     The Children's Amalgam Trial is one of only two randomized trials of its kind, and the only~     such trial in the United States, to address the potential impact of mercury exposure from~     amalgam restorations on neuropsychological and renal function in children.~   "
267445|NCT00065975|"~     This is a pilot randomized trial intended to evaluate the effectiveness of acupuncture,~     chiropractic and massage for chronic back pain in older and younger adults.~   "
267446|NCT00065962|"~     Many drugs used to treat autism target specific symptoms, such as hyperactivity and~     aggressiveness. Few drugs target the core autistic symptoms of impaired social interaction~     and communication. This study will evaluate two forms of the drug secretin for the treatment~     of core autistic symptoms.~   "
267447|NCT00065949|"~     Premature infants are at risk for acute brain injuries and long-term developmental problems~     such as cerebral palsy (CP). Research suggests that high levels of magnesium at and around~     the time of birth may decrease the risk of brain injuries. This study will evaluate the~     effects of giving magnesium to premature infants.~   "
267448|NCT00065936|"~     Self-injurious behavior is behavior in which a person hurts or harms himself. This behavior~     sometimes occurs in people with mental retardation or autism. This study will evaluate~     self-injurious behavior in people with mental retardation or autism and will test the~     effectiveness of new treatments.~   "
267449|NCT00065923|"~     Prader-Willi syndrome (PWS) is a genetic disorder usually caused by the deletion of a~     specific gene. One of the symptoms of PWS is self-injurious behavior (SIB); a common form of~     SIB in PWS patients is skin picking. The injury may be severe enough to require frequent~     medical attention. This trial will evaluate SIB in individuals with PWS and will test the~     effectiveness of the drug topiramate to control SIB.~   "
267450|NCT00065910|"~     Toddlers with autism have poor joint attention skills. Joint attention skills include~     pointing to objects, following another person’s gaze, and responding to invitations to join~     in a social interaction. Improved joint attention skills may lead to better verbal ability as~     the child ages. This study teaches caregivers how to help their toddlers with autism develop~     joint attention skills.~   "
267451|NCT00065897|"~     Prenatal diagnosis can provide information to parents about specific fetal disorders.~     However, invasive prenatal diagnostic procedures are associated with risks to the fetus. This~     study will compare the safety and effectiveness of two methods of invasive prenatal~     diagnosis: amniocentesis and transabdominal chorionic villus sampling (TA CVS).~   "
267452|NCT00065884|"~     This study will examine the effect of valproate, a medication used to treat seizures and~     bipolar disorder, on aggressive behavior in children and adolescents with autism.~   "
267453|NCT00065871|"~     Hormonal birth control methods include birth control pills, patches, and vaginal rings; they~     are normally available only with a doctor’s prescription. This study will evaluate a program~     designed to increase the availability of birth control by allowing pharmacists to give women~     hormonal birth control without a doctor’s prescription. Under this program, pharmacists will~     evaluate women who want to use birth control according to specific guidelines created by~     doctors. If a woman meets the criteria in the guidelines, a pharmacist could then give her~     the appropriate form of hormonal birth control.~   "
267454|NCT00065858|"~     BufferGel is a new contraceptive gel designed to be used with a diaphragm. In addition to~     preventing pregnancy, BufferGel may also prevent some types of sexually transmitted diseases~     (STDs). This study will compare BufferGel to Gynol II, a currently available contraceptive~     gel.~   "
267455|NCT00065845|"~     Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or~     bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can~     be corrected with surgery. However, women who have this surgery may develop urinary~     incontinence. This study will determine how doctors can predict this problem and whether an~     additional surgical procedure at the time of prolapse surgery can prevent the development of~     urinary incontinence.~   "
267456|NCT00031707|"~     RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may~     improve cancer-related weight loss and lack of appetite. It is not yet known whether~     megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a~     combination of both is most effective in treating cancer-related weight loss and loss of~     appetite.~      PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without~     an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty~     acid-enriched nutritional supplement alone in treating patients who have cancer-related~     weight loss and lack of appetite.~   "
267457|NCT00026273|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving them after surgery may kill~     more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and~     leucovorin with or without irinotecan in treating patients who have undergone surgery for~     stage III colorectal cancer.~   "
267458|NCT00025688|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if paclitaxel is more effective with or without~     carboplatin in treating stage IV breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or~     without carboplatin in treating women who have stage IV breast cancer.~   "
267459|NCT00024024|"~     Phase I/II trial to study the effectiveness of BMS-275291 in treating patients who have~     HIV-related Kaposi's sarcoma. Drugs such as BMS-275291 may stop the growth of Kaposi's~     sarcoma by stopping blood flow to the tumor.~   "
267460|NCT00022477|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who~     have recurrent or metastatic colorectal cancer.~   "
267461|NCT00065832|"~     The first line of defense against reading disabilities is good classroom reading instruction.~     This study describes how characteristics of students, teachers, and instruction relate to~     academic achievement in inner-city kindergarten through Grade 4 classrooms.~   "
267462|NCT00065819|"~     African American mothers infected with HIV face unique challenges in management of their~     disease. The goal of this study was to determine the effectiveness of an HIV self-care and~     symptom management program designed to help low-income African American mothers with HIV.~   "
267463|NCT00065806|"~     The purpose of this study is:~        1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of~          atherosclerosis that predisposes children with SLE to cardiovascular events in~          adulthood.~        2. To assess the safety of intermediate-term (36 months) treatment of children and young~          adults with atorvastatin.~        3. To further characterize the course of SLE in children and young adults, by establishing~          a cohort of pediatric SLE patients to be followed prospectively.~        4. To establish a mechanism for conducting clinical trials in rare pediatric rheumatic~          diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).~   "
267464|NCT00065793|"~     To evaluate very low density lipoprotein (VLDL) and low density lipoprotein (LDL) particle~     types as predictors of initial coronary events.~   "
267465|NCT00065780|"~     To rescan 6,700 subjects in the MESA study to obtain computed tomography measures of~     calcification.~   "
267466|NCT00065767|"~     The aim of this study is to determine the effectiveness of treatment with raloxifene, an~     estrogen-like medication approved by the Food and Drug Administration for the treatment of~     osteoporosis, in improving memory and the ability to live independently in postmenopausal~     women with Alzheimer's disease.~   "
267467|NCT00065754|"~     This study examines the mechanisms, including brain imaging of placebo analgesia~   "
267468|NCT00065741|"~     A series of clinical studies will be conducted in normal, healthy adult volunteers to~     evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when~     botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and~     botanicals are known to rely upon or to modulate, respectively, metabolism via~     glucuronidation.~   "
267469|NCT00065728|"~     The purpose of this study is to investigate the long-term efficacy and safety of posterior~     juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.~   "
267470|NCT00065715|"~     The design and interpretation of randomized trials is intimately connected to the use of~     placebo. The nature and magnitude of placebo effects, however, is very poorly understood.~     This study will assess and compare placebo effects and physician interaction effects within a~     community-acquired common cold model. The goal of this study is to assess two kinds of~     placebo affects and how physician interaction effects;~        1. The effect of receiving blinded placebo, compared to no treatment; and~        2. The effect of receiving open-label active Echinacea treatment compared to blinded active~          treatment.~   "
267471|NCT00065702|"~     The purpose of this study is to evaluate the efficacy of individualized classical homeopathy~     in treatment of persons with fibromyalgia and to determine the usefulness of~     electroencephalographic and electrocardiographic measures to serve as markers of differences~     between active and placebo treatment.~   "
267472|NCT00065689|"~     The purpose of this study is to determine whether bright light improves the sleep, mood, and~     behavior of persons with Alzheimer's disease and related dementias (AD) who live in long-term~     care settings and, if so, to determine the best timing for the light therapy. The light~     levels being used in the study have been shown to improve depression in persons with seasonal~     affective disorder (SAD) and to relieve sleep problems in persons with jet lag and other body~     rhythm disturbances. Because persons with AD often will not remain still in front of a~     fluorescent panel, this project has involved renovations in the study units that provide for~     even, regulated, high-intensity light in all public areas of the study settings.~   "
267501|NCT00005604|"~     Phase I trial to study the effectiveness of interleukin-12 plus interleukin-2 in treating~     patients who have advanced solid tumors. Interleukin-12 may kill tumor cells by stopping~     blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.~     Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining the~     two drugs may kill more cancer cells~   "
267517|NCT00065234|"~     The purpose of this study is to determine if acupuncture is effective in preventing prolonged~     postoperative paralysis of the gastrointestinal tract among patients undergoing~     colostomy/ileostomy closure.~   "
267473|NCT00065676|"~     Quercetin is a compound naturally found in various foods. It may have some role in the~     treatment of obesity and diabetes.~      The purpose of this study is to investigate research volunteers with obesity or obesity with~     type 2 diabetes to determine whether quercetin affects the way glucose is absorbed by the~     body.~      Thirty two participants aged 19 to 65 who are considered to be medically obese or obese with~     type 2 diabetes will be enrolled in this study. Before the onset of treatment, they will~     undergo a medical history, physical exam, blood work, and urinalysis. During the study,~     participants will be given an oral glucose tolerance test three times; during these tests~     they will receive 1 or 2 grams of quercetin, or placebo. Researchers will collect blood~     samples and analyze the effect of the treatment on blood glucose.~   "
267474|NCT00065663|"~     Patients with diabetes may develop chronic wounds that respond poorly to treatment. Gene~     therapy with the platelet-derived growth factor-B gene has been shown to help with the~     healing of chronic wounds. This study will evaluate a new way to deliver the gene to the~     wound tissue.~   "
267475|NCT00065650|"~     The purpose of this study is to determine the feasibility and effectiveness of a~     multimodality Vedic Medicine treatment protocol for the management of newly diagnosed type 2~     diabetes.~   "
267476|NCT00065624|"~     The goal of this study is to determine whether a short treatment with lipoic acid, an~     antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity~     and decreases oxidant stress in persons with elevated blood cholesterol.~   "
267477|NCT00065585|"~     This is a trial to clarify the extent to which acupuncture needling can diminish the effect~     of chronic back pain on patient functioning and symptoms.~   "
267478|NCT00065572|"~     The purpose of this study is to assess the biological activity of ZD6126 in subjects with~     newly diagnosed metastatic renal cell carcinoma (stage IV).~   "
267479|NCT00065559|"~     COX-2 is an enzyme that is found in several different tissues in the body. COX-2 appears to~     produce a substance called prostaglandins, mainly at sites of inflammation. Several drugs~     have been approved by the FDA that inhibit COX-2 such as celecoxib, or brand name Celebrex®.~     These drugs are primarily used in patients with osteoarthritis and rheumatoid arthritis to~     decrease inflammation and pain. COX-2 inhibitors have been developed because they are more~     selective in treatment of inflammation and pain and tend to have fewer gastrointestinal side~     effects than NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen,~     naproxen, etc.~      The normal adult kidney expresses COX-2 in various regions. Prostaglandins, which are~     produced in the kidney by COX-2, may contribute to glomerular and tubulointerstitial~     inflammatory diseases (types of kidney diseases due to inflammation). In some animal studies,~     COX-2 inhibitors have been shown to be potentially beneficial in reducing the amount of~     protein spilled in the urine and preserving kidney function with these inflammatory kidney~     diseases. This study will compare the effects of COX-2 inhibitor to placebo (an inactive~     substance) in patients with diabetic nephropathy (kidney disease due to diabetes) and~     proteinuria (spilling protein in the urine) on 24-hour urinary protein excretion.~      This study is designed to see whether COX-2 inhibitors are useful in treating diabetic~     patients with kidney disease. The purpose of this study is a short-term pilot study that will~     allow the gathering of important data such as the ability to carry out the study and carry it~     out safely. Subjects with proteinuria and diabetic kidney disease already on ACE~     (Angiotensin-Converting Enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) therapy~     (types of blood pressure medicines) will be randomized to a type of study in which each~     subject will serve as their own control. The study is set up so that each subject will~     receive either the COX-2 inhibitor or placebo for a period followed by a period of no drug~     and then followed by a period of receiving either the COX-2 inhibitor or placebo (whichever~     they did not receive the first period).~   "
267480|NCT00065546|"~     The purpose of this study is to increase our understanding of how much choline humans need to~     get from their diet. Choline is an essential nutrient found in many foods, including eggs and~     milk. In addition to dietary sources, choline can be made in the liver. Choline is important~     in making membranes or wrappers for all the cells in the body and for making chemicals that~     allow nerve cells to work properly. In a previous study we found that the dietary requirement~     for choline varies greatly from person to person. This was caused, in part, by how much~     estrogen a person has and their genetic makeup. We are conducting this study to explore how~     estrogen levels and specific differences in genes influence choline requirements so that we~     can refine the dietary recommendations for this nutrient.~   "
267481|NCT00065637|"~     Daily parathyroid hormone (PTH) is approved by the FDA for the treatment of osteoporosis.~     This study will evaluate the safety and effectiveness of PTH when given once a week.~   "
267482|NCT00014560|"~     RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing~     substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients~     who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.~   "
267483|NCT00014261|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. PEG-interferon alfa-2B may interfere with the growth of cancer~     cells. Combining temozolomide with PEG-interferon alfa-2B may be an effective treatment for~     advanced solid tumors.~      PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and~     PEG-interferon alfa-2B in treating patients who have advanced solid tumors.~   "
267484|NCT00014248|"~     RATIONALE: Adenosine triphosphate may decrease weight loss and improve muscle strength in~     patients with advanced solid tumors.~      PURPOSE: Phase I trial to study the effectiveness of adenosine triphosphate in controlling~     loss of weight and loss of muscle mass in patients who have advanced solid tumors.~   "
267485|NCT00014209|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to~     previous treatment.~   "
267486|NCT00010127|"~     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune~     response to kill prostate tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have metastatic prostate cancer.~   "
267499|NCT00065442|"~     Provenge is an investigational product designed to activate a man's own antigen presenting~     cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an~     immune response against them.~      Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level.~     One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase~     3 study.~      If you decide to participate and are eligible, you will be enrolled in the study and randomly~     assigned to receive either active product or placebo. There are two chances in three that you~     will receive Provenge. After receiving treatment, you will be monitored at regular intervals~     until the study endpoints are met. At the end of the trial, men who received placebo will~     have the opportunity to be treated with active product in another study.~   "
267487|NCT00065611|"~     Focal segmental glomerulosclerosis (FSGS) and minimal change disease are kidney diseases that~     are associated with increased excretion of protein in the urine. Approximately half of FSGS~     patients will lose kidney function within 8 years of diagnosis and will require dialysis. The~     purpose of this study is to determine whether intermittent oral steroid therapy can cause~     sustained remission of FSGS and MCD.~      Approximately 70 participants, including adults and children older than age 2, will be~     enrolled in this study. They will receive 48 doses of oral dexamethasone over a period of 48~     weeks. One group will take two daily doses every 2 weeks; the other group will take four~     daily doses every 4 weeks. Doctors will monitor participants before, during, and after the~     steroid treatment with extensive exams and testing. At the completion of the study,~     researchers will evaluate the safety and efficacy of the drug treatment.~   "
267488|NCT00065533|"~     The purposes of this study are to determine the safety of pemetrexed and any side effects~     that might be associated with it, whether pemetrexed can help patients with breast cancer and~     how much pemetrexed should be given to patients.~   "
267489|NCT00065507|"~     This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg~     QD in patients who have chronic hepatitis B infection and hepatic decompensation. The~     patients are treated for 96 weeks after the last subject is randomized.~   "
267490|NCT00006799|"~     RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in~     limiting weight loss caused by cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting~     weight loss and improving quality of life in patients who have head and neck cancer and are~     undergoing radiation therapy.~   "
267491|NCT00006486|"~     Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating~     patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of~     kidney cancer by stopping blood flow to the tumor~   "
267492|NCT00006453|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or~     without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has~     not responded to previous chemotherapy.~   "
267493|NCT00006352|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. BCG may activate the immune~     system to kill tumor cells. Combining monoclonal antibody therapy with BCG may kill more~     tumor cells. It is not yet known if monoclonal antibody therapy plus BCG is an effective~     treatment for limited-stage small cell lung cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of monoclonal antibody~     therapy plus BCG in treating patients who have limited-stage small cell lung cancer.~   "
267494|NCT00006240|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combining phenylbutyrate,~     dexamethasone, and sargramostim in treating patients who have refractory or relapsed acute~     myeloid leukemia.~   "
267495|NCT00065468|"~     The primary objective of this study is efficacy. The primary efficacy endpoint of this study~     is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus],~     administered intravenously [IV] once weekly and the combination of CCI-779, administered IV~     once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW],~     compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in~     poor-prognosis subjects with advanced RCC.~   "
267496|NCT00006229|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether paclitaxel and carboplatin are more~     effective with or without BMS-275291 for non-small cell lung cancer.~      PURPOSE: Randomized phase II/III trial to compare the effectiveness of paclitaxel and~     carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic~     non-small cell lung cancer.~   "
267497|NCT00006081|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 and paclitaxel~     in treating patients who have unresectable locally advanced or metastatic stomach cancer.~   "
267498|NCT00065455|"~     Retinitis pigmentosa (RP) is a collective term for a group of inherited retinal dystrophies~     that are a major cause of irreversible blindness. RP of some type occurs in approximately 1~     out of 3500 persons in the United States(1). Gene mutations are responsible for the majority~     of RP. To date, mutations have been identified in 30 different genes linked to RP(2). The~     visual prognosis of RP is poor, since the gradual but relentless visual field loss leads~     eventually to some degree of blindness(3). Although no effective treatment for RP has been~     identified, participants supplemented with a daily oral dose of 15,000 IU vitamin A palmitate~     have shown, on average, a slower rate of deterioration of retinal function when the~     intervention is continued over several years(4). The purpose of this research is to determine~     whether administration of high oral doses of vitamin A can acutely improve cone photoreceptor~     function in RP participants as measured by electroretinography (ERG). In this interventional,~     non-randomized, prospective, pilot study, 5 participants will receive a daily oral dose of~     50,000 IU of vitamin A palmitate for 4 weeks, followed by a maintenance dose of 15,000 IU~     daily for the subsequent 2 weeks. The primary efficacy outcome is a relative percentage~     change in ERG response amplitude subsequent to vitamin A supplementation. A secondary~     efficacy outcome is a relative percentage change in implicit time from pre- to post- vitamin~     A supplementation, with improvement specified as a shorter response implicit time. Other~     secondary outcomes will be improvements in visual field (Humphery, 10-2; sum of thresholds).~     Safety outcomes include visual fields, ETDRS visual acuity, intraocular pressure, serum~     vitamin A level and liver function tests.~   "
267500|NCT00065429|"~     This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small~     cell lung cancer and other solid tumors.~   "
267502|NCT00004887|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether paclitaxel and carboplatin is more~     effective than standard chemotherapy for advanced non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and~     carboplatin chemotherapy with that of standard chemotherapy in treating patients who have~     stage III or stage IV non-small cell lung cancer that cannot be removed during surgery.~   "
267503|NCT00065416|"~     This study will provide the basis for a full-scale trial to evaluate the effectiveness and~     safety of therapeutic massage for chronic neck pain (CNP).~   "
267504|NCT00065403|"~     Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial~     uses a manualized acupuncture treatment format that closely follows clinical practice and~     allows flexibility in designing individualized treatments. In addition, a second parallel~     qualitative study will follow a subgroup of patients throughout the trial to explore the~     relationships between patients' interpretations and understandings (what anthropologists call~     meaning) of irritable bowel and their response to treatment. Cortisol levels (an important~     stress hormone) will also be assessed.~      This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.~   "
267505|NCT00065364|"~     Premature infants born between 28 and 33 weeks’ gestation often have significant brain~     damage. Brain damage can be caused by the much greater stimulation the infant receives in the~     neonatal intensive care unit (NICU) as compared to the mother’s womb. This study will test~     the effectiveness of specialized and individualized NICU developmental care in preventing~     brain damage.~   "
267506|NCT00065351|"~     For each subject the study will consist of two phases: a treatment phase and a follow-up~     phase. Screening procedures will take place within 28 days of baseline.~      Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent~     CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma~     paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every~     4 weeks thereafter.~      Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will~     continue to be followed for survival and post-treatment phase anti-myeloma treatment.~   "
267507|NCT00065338|"~     These studies will provide us with enormous insight regarding how obese patients adapt~     energetically during negative energy balance. We will gain fundamental information regarding~     the metabolic implications of combining food restriction with a walking program compatible to~     that advocated by statutory agencies. These studies will lead to improved understanding of~     the energetic adaptation that occurs during negative energy balance and how best to treat~     patients with obesity.~   "
267508|NCT00065325|"~     The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin~     (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer.~     Patients will be treated until disease progression or until the investigator has determined~     that treatment is not in the best interest of the patient, whichever occurs first.~   "
267509|NCT00004253|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Specialized radiation therapy delivers a high dose of radiation~     directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and~     specialized high-dose radiation therapy in treating patients who have stage II or stage III~     non-small cell lung cancer that cannot be removed by surgery.~   "
267510|NCT00065390|"~     This study will examine whether the drug pyrimethamine can shrink lymph nodes and spleen in~     patients with autoimmune lymphoproliferative syndrome (ALPS). In this disease, lymphocytes~     (white blood cells) do not die as they normally would. As a result, patients have enlarged~     lymph glands, spleen, or liver, and other problems that may involve blood cell counts and~     autoimmune disease (overactivity of the immune system). Pyrimethamine is an orally~     administered antibiotic that has been used to treat or prevent malaria and toxoplasma, and~     may be effective in shrinking lymph nodes and spleen.~      Patients with ALPS who are between 2 and 70 years of age and have had lymph gland enlargement~     for at least 1 year may be eligible for this study. Candidates will be screened with a~     medical history and physical examination, blood tests, and possibly a bone marrow test.~     Females of reproductive age will be screened with a urine pregnancy test. Women who are~     capable of becoming pregnant must use an effective method of birth control during the entire~     study period, because, taken during early months of pregnancy, pyrimethamine can cause birth~     defects in the fetus. Women who are pregnant or nursing are excluded from the study.~      Participants will undergo the following tests and procedures:~        -  CT scan: For this test, the patient lies still in the CT scanner while images are taken~          of the neck, chest, and stomach area. A contrast dye is injected into a vein to brighten~          the CT images. Very young children will be evaluated on a case by case basis to~          determine whether a CT scan will be performed.~        -  Bone marrow biopsy: Participants undergo this test to rule out underlying bone marrow~          disease if they have not had a bone marrow test done in the last six months prior to~          enrolling in pyrimethamine study, as pyrimethamine can affect bone marrow function.~          Under local anesthesia, a needle is inserted into the back part of the hipbone and a~          small amount of marrow is removed. (Children are sedated for this test.)~        -  Leukapheresis: This is a procedure for collecting a small proportion of circulating~          white blood cells while conserving the majority of blood cells. Specifically, blood is~          drawn from a needle placed in an arm vein and is directed into a cell separator machine,~          which separates the blood cells by spinning. A small proportion of circulating white~          cells are removed, and the red cells, platelets, plasma and majority of white cells are~          returned to the patient's blood circulation. Only patients who are 7 years of age or~          older and weigh at least 55 pounds undergo this procedure. Other participants who choose~          not to have apheresis will have about 3 tablespoons of blood drawn instead.~        -  Pyrimethamine administration: When the above tests are completed, participants begin~          taking pyrimethamine. The dose is determined according to the individual's weight and is~          gradually increased during the study period. Patients take the drug twice a week for a~          total of 12 weeks.~        -  Blood tests: Blood samples are collected during weeks 2, 4, 6, 8, and 10 after beginning~          treatment, and 2 weeks after the last dose of pyrimethamine. The purpose of these blood~          tests is to check for possible drug-related side effects. Patients who develop a skin~          rash, mouth sores or other side effects may have one or more doses of the treatment drug~          withheld. When indicated, the patient will be directed to stop taking the study drug. If~          needed, drug side effects will be treated with a vitamin supplement, folinic acid, taken~          by mouth, 3 times weekly.~        -  Evaluations at the NIH Clinical Center will comprise of a pretreatment visit, one end of~          treatment visit at the end of 12 weeks and an optional post-treatment visit 3months~          after stopping pyrimethamine therapy.~      Patients who respond well to treatment may be asked to return to NIH for additional visits at~     3, 6, and 12 months after the treatment has ended for repeat evaluations. If their lymph~     glands or spleen become much larger after stopping pyrimethamine, they will be offered~     treatment for another 12 weeks. If they respond to the second course of treatment, they will~     return to NIH again after 3, 6, and 12 months. If the symptoms return again, patients will be~     asked to resume treatment for an additional 6 months or more. They will have blood drawn~     periodically by their private physician and will return to NIH for evaluation every 12 weeks.~   "
267511|NCT00065377|"~     This study will examine whether glucosamine affects the way the body responds to insulin.~     Insulin is a hormone that causes the body to use glucose (sugar). Insulin does not work as~     well in overweight people, causing a condition called insulin resistance. Insulin also~     increases the flow of blood into muscle by opening inactive blood vessels. This study will~     test whether glucosamine, a nutritional supplement that many people take to treat arthritis,~     can cause or worsen insulin resistance or change how blood vessels react to insulin in normal~     weight and overweight people.~      Healthy normal weight and overweight volunteers between 21 and 65 years of age may be~     eligible for this study. Candidates will be screened with a brief physical examination,~     medical history, and blood and urine tests. After screening, participants will have three~     additional outpatient clinic visits for the following procedures:~      Visit 1~        -  Glucose clamp test to measure the body's response to insulin: For this procedure, a~          needle is placed in a vein of each arm, one for drawing blood samples, and one for~          infusing glucose and a potassium solution. The glucose is infused continuously during~          this 4-hour test and blood is drawn frequently to monitor glucose and insulin levels.~          After the test, blood glucose levels are monitored for another 2 hours to make sure they~          remain at an adequate level to prevent hypoglycemia (low blood sugar).~        -  Blood flow measurement: Blood flow in the brachial artery of the arm is measured to~          assess how many capillaries (very small blood vessels) are being used to supply~          nutrients and oxygen to the muscle in the forearm. This test is done at the same time as~          the glucose clamp test. Blood flow is measured using a technique called contrast~          ultrasound. A small amount of contrast agent consisting of gas-filled bubbles the size~          of red blood cells is infused over 10 minutes through one of the catheters placed in the~          vein for the glucose clamp test. The contrast agent is infused twice, once at the~          beginning of the glucose clamp test and once at the end of the test. The contrast~          material creates a signal in response to ultrasound that provides information about the~          distribution of capillaries in the forearm.~        -  Assignment to medication group: Participants are randomly assigned to take either~          glucosamine or placebo three times a day by mouth for 6 weeks. At the end of the 6~          weeks, no study drug is taken for 1 week, and then participants cross-over~          medications, those who took glucosamine for the first 6 weeks take placebo for the next~          6 weeks and vice versa.~      Visits 2 and 3~      For these visits, the glucose clamp test and blood flow measurements are repeated. Visit 2 is~     scheduled at the end of the first 6-week treatment period, and Visit 3 is scheduled at the~     end of the second 6-week treatment period.~   "
267512|NCT00065312|"~     The purpose of this study is to determine if an investigational drug is safe and efficacious~     for poorly controlled type 2 diabetes mellitus.~   "
267513|NCT00065299|"~     Phenylketonuria (PKU) is a rare genetic condition. If not treated, PKU can cause severe~     mental retardation. Women with PKU are advised to eat a special diet when pregnant to prevent~     mental retardation in their children. This study will evaluate the effects of that diet on~     the children of mothers with PKU.~   "
267514|NCT00065286|"~     Akathisia is a movement disorder that is often a side effect of certain psychiatric drugs.~     People with akathisia are unable to sit or keep still, complain of restlessness, fidget, rock~     from foot to foot, and pace. Akathisia is sometimes called “restless legs syndrome.” The~     drugs that can cause akathisia are most often used to treat patients with schizophrenia or~     mental retardation (MR). This study will evaluate akathisia in both schizophrenic and MR~     patients who either have long-term akathisia or who are starting treatment with psychiatric~     drugs.~   "
267515|NCT00065273|"~     Psychiatric drugs are often used to treat behavioral symptoms of mental~     retardation/developmental delay (MR/DD). These drugs can cause serious side effects. Newer~     drugs may have decreased side effects. This study will compare new and old drugs used to~     treat behavioral symptoms in people with MR/DD.~   "
267520|NCT00065260|"~     Severe aplastic anemia, characterized by pancytopenia and a hypocellular bone marrow, is~     effectively treated by immunosuppressive therapy, usually a combination of antithymocyte~     globulin (ATG) and cyclosporine (CsA). Survival rates following this regimen are equivalent~     to those achieved with allogeneic stem cells transplantation. However, approximately 1/3 of~     patients will not show blood count improvement after ATG/CsA. General experience and small~     pilot studies have suggested that such patients may benefit from further immunosuppression.~     Furthermore, analysis of our own clinical data suggest that patients with poor blood count~     responses to a single course of ATG, even when transfusion-independence is achieved, have a~     markedly worse prognosis than patients with robust hematologic improvement. The management of~     such cases is uncertain.~      This study will enroll patients who are either refractory to h-ATG (continued severe~     pancytopenia) or who have only modest improvement in blood counts (weak hematologic~     responders) to receive a further immunosuppressive therapy, delivered either as rabbit ATG~     (Thymoglobulin, r-ATG) or a humanized monoclonal antibody to T-cells, alemtuzumab (Campath-1H~     ). Primary endpoint will be response rate at 3 months defined as no longer meeting criteria~     for severe aplastic anemia. Relapse, robustness of hematopoietic recovery at 3 months,~     survival and clonal evolution to paroxysmal nocturnal hemoglobinuria (PNH), myelodysplasia~     and acute leukemia will be the secondary endpoints.~   "
267521|NCT00065195|"~     The purpose of this study is to determine whether massage therapy is effective in reducing~     pain and distress and improving quality of life among cancer patients at life's end.~   "
267522|NCT00065182|"~     The purpose of this study is to compare the efficacy and safety of a weekly regimen of two~     FDA approved drugs in combination versus one FDA approved drug in subjects with advanced~     non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or~     HYCAMTIN.~   "
267523|NCT00065169|"~     The purpose of this study is to determine whether the anti-inflammatory drug celecoxib can~     delay the onset of Alzheimer Disease (AD) in people with Age Associated Memory Impairment~     (AAMI). This study will also evaluate genetic risk and brain structure as potential~     predictors of mental decline.~   "
267524|NCT00065156|"~     This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy~     administered to red blood cell (RBC) transfusion-dependent subjects with low- or~     intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33)~     cytogenetic abnormality. Screening procedures will take place within 28 days of the first day~     of lenalidomide treatment. Subjects will receive lenalidomide in 28-day cycles for up to 6~     cycles, or until bone marrow disease progression or progression/relapse following erythroid~     hematologic improvement is documented. Study visits will occur every cycle (every 28 days)~     and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety~     and efficacy assessments to be performed during the study are outlined in the Schedule of~     Study Assessments.~   "
267525|NCT00065143|"~     The goal of this clinical research study is to learn if clofarabine, when given in~     combination with ara-C (cytarabine), can help to improve the disease's response to therapy~     and to increase the duration of response in patients who are 50 years or older with leukemia.~     The safety of this combination treatment will also be studied.~   "
267526|NCT00065130|"~     This trial is conducted in the United States of America (USA). The purpose of this study is~     to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to~     regular human insulin for the control of blood glucose after meals in women who develop~     diabetes during pregnancy.~   "
267527|NCT00065117|"~     The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in~     Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic~     Colorectal Cancer.~   "
267528|NCT00065104|"~     This study's purpose is to learn how dehydroepiandrosterone (DHEA) affects the HIV virus, the~     immune system, hormone levels, body composition and quality of life.~   "
267529|NCT00065078|"~     This study will evaluate a program that provides birth control to low income and minority~     women through home visits by a community health nurse. The goal of the program is to reduce~     unwanted pregnancies.~   "
267530|NCT00065065|"~     This is a multicenter, randomized, double-blind, placebo-controlled study evaluating~     rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks.~     The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the~     treatment of mild to moderately active ulcerative colitis. Disease activity will be measured~     using a standard disease activity index. Calculation of the index requires patients to~     undergo flexible sigmoidoscopy at the start of the study and at week 12.~   "
267531|NCT00065052|"~     The purpose of this study is to determine if limiting television (TV) and computer time will~     result in a stabilization or smaller increase in body mass index (BMI), lower energy intake,~     and increased physical activity in 4-7 year old obese (>85th BMI percentile) children over~     two years.~   "
267532|NCT00065039|"~     The study will be conducted in four Catholic schools with children enrolled in Grades 2~     through 6. Girls and boys and children of all racial types are eligible for participation in~     the study. We anticipate that approximately 1,000 to 1200 children will volunteer for the~     study. We request enrollment of 1200 children. To participate, parents must grant written~     consent and the child must assent by signing a consent form that is attached. Two of the four~     schools that volunteer for participation in the study and are approved by the research team,~     will be randomly assigned to a health promotion program called Wise Mind for Diet and~     Physical Activity. The other two schools will be randomly assigned to a program called Wise~     Mind for Avoidance of Alcohol, Drugs, and Tobacco. Students will receive the program in the~     school that they attend. They will not be allowed to select one of the programs and will~     receive only one program, i.e., the program in their school. Both health promotion programs~     will last for two academic years. Each year, every child that is a research participant will~     be tested on two occasions, once during the first two months of school (Sept and Oct), and~     once during the last two months of school (March and April). Testing will not be conducted~     during May in order to avoid interference with school activities at the end of the academic~     year. All children (in all four schools) will have the same testing. The testing will involve~     confidential measurement of eating habits, food intake, physical activity habits, attitudes~     about alcohol, drugs, and tobacco, body weight and height, body fatness, body image, mood,~     and self-esteem. The measurement techniques that will be used for this measurement will~     include: questionnaires, weighing, measurement of height, and photography of foods before and~     after eating. All measurements will be confidential and will not be released to anyone that~     is not involved in the management of the study, including school personnel. The total time~     requirement for each testing period is expected to be approximately three hours, spread over~     four testing periods during a two-week period. The testing periods will be conducted in~     conjunction with school administrators and will not be scheduled to conflict with important~     school activities, classes, or academic tests. A Data and Safety Monitoring Board (DSMB) will~     be organized to provide oversight for the conduct of the study.~   "
267651|NCT00033384|"~     RATIONALE: CI-1040 may stop the growth of tumors by blocking the enzymes necessary for cancer~     cell growth and by stopping blood flow to the tumor.~      PURPOSE: Phase II trial to study the effectiveness of CI-1040 in treating patients who have~     metastatic or unresectable breast, colon, pancreatic, or non-small cell lung cancer.~   "
267533|NCT00065026|"~     Regular physical activity is important for good health. Women, particularly women with low~     incomes, have many personal barriers to regular physical activity. The purpose of this study~     is to reduce environmental barriers to physical activity for women in two specific low-income~     neighborhoods (in Louisville, KY) by providing opportunities for safe physical activity and~     addressing barriers such as lack of child care. Two groups of women will have pretest~     information (cholesterol, blood sugar, blood pressure, percent body fat, height, weight,~     waist and hip measurements) collected and the same information 6 months later at post-test.~     One group will have access to multiple physical activity opportunities in their neighborhood~     and at the neighborhood community center. An advanced registered nurse practitioner will~     facilitate the activity opportunities. The groups will be compared on their pretest and~     post-test information to see if the group with the physical activity opportunities has~     increased physical activity as measured by pedometer and self-report questionnaire, and to~     see if there are changes in the measures tested at pre and post (measures that may be~     improved by regular physical activity).~   "
267534|NCT00065013|"~     We will assess whether undesirable loss of lean tissue following gastric bypass surgery for~     obesity can be minimized by protein supplementation and exercise training.~   "
267535|NCT00065000|"~     This is a 3-year pilot study funded by National Institute of Health will assess and evaluate~     obesity-related health outcomes of a real-life policy decision, recently voted on and adopted~     by the Seattle School Board.~   "
267536|NCT00004204|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have recurrent or progressive malignant glioma.~   "
267537|NCT00004006|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs~     and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy followed by bone marrow transplantation in treating patients who have retinoblastoma.~   "
267538|NCT00003895|"~     This randomized pilot phase II trial studies how well vaccine therapy works in treating human~     leukocyte antigen class 1 histocompatibility, A-2 (HLA-A2) positive patients with melanoma.~     Vaccines made from peptides may help the body build an effective immune response to kill~     tumor cells.~   "
267539|NCT00003795|"~     RATIONALE: Quality-of-life assessment in cancer survivors may help determine the long-term~     effects of having had gynecologic cancer and may help improve the quality of life for future~     cancer survivors.~      PURPOSE: This clinical trial is studying the quality of life in survivors of gynecologic~     cancer.~   "
267540|NCT00003759|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies such as BCG use different ways to stimulate~     the immune system and stop cancer cells from growing. It is not yet known whether AD 32 is~     more effective with or without BCG after surgery for superficial bladder cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of AD 32 with or without BCG~     after surgery in treating patients who have newly diagnosed or recurrent superficial bladder~     cancer.~   "
267541|NCT00064987|"~     Men with idiopathic hypogonadotropic hypogonadism (IHH, Kallmann Syndrome) may have small~     testicular size, low testosterone levels, no history of puberty, and infertility. These men~     lack a hormone called gonadotropin releasing hormone (GnRH) that stimulates the development~     and maturation of the testes. This study will investigate the impact of hormonal treatments~     on men with IHH. The goal of hormonal therapy is to maximize the potential fertility in these~     individuals.~   "
267542|NCT00064974|"~     This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy~     administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood~     cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not~     have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28~     days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in~     28-day cycles for up to 6 cycles, or until bone marrow disease progression or~     progression/relapse following erythroid hematologic improvement (Appendix I) is documented.~     Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess~     hematological parameters will occur every 14 days. Safety and efficacy assessments to be~     performed during the study are outlined in the Schedule of Study Assessments.~   "
267543|NCT00064961|"~     This study addresses the high risk of weight gain associated with smoking cessation in women.~     The obesity prevention pilot study is designed for the primary prevention of weight gain that~     can lead to overweight in normal-weight women, that can progress to obesity in women who are~     already overweight, and for the prevention of additional weight gain in obese women with BMI~     greater than or equal to 30.0. Fat and other macronutrient intake, specifically, sugar,~     complex carbohydrates, and protein, are analyzed as a target for individually tailored,~     weight control intervention following smoking cessation in Caucasian and African American~     women.~   "
267544|NCT00064935|"~     When a woman becomes pregnant, the fertilized egg attaches itself to the lining of the uterus~     (endometrium). The endometrium is constantly changing throughout a woman’s menstrual cycle in~     response to the female hormones estrogen and progesterone. The endometrium must have certain~     characteristics (be at a specific phase in its cycle) in order for the fertilized egg to~     successfully attach. Infertility may be caused by an out of phase endometrium (i.e., the~     endometrium doesn’t have the right characteristics when the fertilized egg reaches it). The~     purpose of this study is to evaluate whether the endometrial biopsy is useful in predicting~     the potential for becoming pregnant and bearing a child.~   "
267545|NCT00064922|"~     The purpose of this study is to examine the effects of incentive programs for the treatment~     of nicotine dependence in women who have problems with substance dependence.~   "
267546|NCT00064870|"~     The purpose of the Alzheimer's Disease Genetics Study is to identify the genes that are~     responsible for causing Alzheimer's Disease (AD). One of the ways in which the risk factor~     genes for late onset AD can be investigated is by identifying and collecting genetic material~     from families with multiple members diagnosed with AD or dementia.~   "
267548|NCT00064909|"~     This study will use magnetic resonance imaging (MRI) to examine and compare changes in blood~     flow and blood volume in the brains of normal volunteers and patients with multiple sclerosis~     (MS). Patients with MS-an inflammatory disease that attacks the brain and spine-may have new~     blood vessel formation (called angiogenesis) within the brain that may or may not contribute~     to the disease or help in repairing the brain. It is not known if these new vessels behave in~     the same way as the naturally occurring vessels. MRI uses a strong magnetic field and radio~     waves to generate brain images that provide information on brain chemistry, function, and~     blood flow. The results of this study may lead to a better understanding of MS.~      Healthy normal volunteers and patients with multiple sclerosis 18 years of age and older may~     be eligible for this study. Normal volunteers must have no history of signs or symptoms of~     central nervous system disease. Patients with MS will be recruited from the NIH~     Neuroimmunology MS clinic.~      All participants will undergo MRI. For this procedure, the subject lies still on a table that~     slides into a narrow metal cylinder (the MRI scanner). Scanning varies from 20 minutes to 3~     hours, with most scans lasting between 45 and 90 minutes. During the scan, the subject wears~     earplugs to muffle loud knocking noises caused by electrical switching of the radio frequency~     circuits. The subject can communicate with the MRI staff at all times during the procedure.~      During the scan, the subject wears a mask and breathes in room air or air containing 6%~     carbon dioxide (CO2). (Room air contains approximately 0.04% CO2, which is about 150 times~     less than the 6% CO2. Air that is normally breathed out contains about 5% CO2.) Breathing 6%~     CO2 increases the amount of blood flow in the brain that can be measured using MRI. The total~     duration of a single 6 percent CO2 inhalation will not exceed 10 minutes.~      A catheter (thin plastic tube) is placed in a vein in the subject's arm before he or she~     enters the scanner. At some point during the scan, a contrast agent called gadolinium DTPA is~     injected into the vein through the catheter. This agent enables clearer images of the brain.~   "
267549|NCT00064896|"~     The goal of this study is to develop advances in cardiovascular diagnostic and treatment~     methods using magnetic resonance imaging (MRI), a test that uses a strong magnetic field and~     radio waves to show anatomic detail. For the scan, the patient lies on a table in a cylinder~     containing a magnetic field. He or she can communicate with a staff member at all times~     during the procedure.~      Patients 18 years of age or older who require 1) catheterization of the leg arteries for~     diagnosis or treatment of blocked arteries, or 2) heart catheterization for diagnosis or~     treatment of coronary artery disease or other heart problems may be eligible for this study.~     Participants will undergo one of the following procedures:~      Blood Flow Measurement Using Standard Techniques and MRI~      For patients with blockage in a leg artery, blood flow will be measured before and after~     successful catheter-based treatment (angioplasty or stenting) using standard venous occlusion~     plethysmography and a newer MRI technique. (Patients whose treatment is not successful will~     not undergo follow-up blood flow measurements in this study.) For venous occlusion~     plethysmography, a large pressure cuff is placed around the upper or lower legs. Thin elastic~     bands called a strain gauge are placed around the calves to measure blood blow to the legs.~     The pressure cuffs are inflated for 5 minutes, preventing blood from flowing to the legs, and~     are then deflated, allowing the blood to rush to the legs. A smaller cuff is inflated to a~     low pressure, and the strain gauge measures this maximum blood flow to the legs for 1 or 2~     more minutes. For the new MRI technique, blood flow is measured while the patient is in the~     MRI scanner. Flow is first measured with the patient at rest. Then, the large pressure cuff~     is inflated for 5 minutes. The cuff is deflated and additional images are taken. Before the~     cuff is deflated, a dye called gadolinium contrast is injected into an arm vein to brighten~     the images. Patients may undergo six to eight cuff inflations on four to six different days.~      Fusion of X-Ray and MRI Images of Peripheral Arteries~      For patients with blockage in a leg artery Participants will undergo catheterization and MRI~     of the legs. Special plastic beads are taped to the leg(s) to help compare the MRI and x-ray~     pictures. For the catheterization procedure, x-rays of the blood vessels are taken to guide~     placement of the catheters. Contrast dye is injected to brighten the images of the blood~     vessels. These injections work well in normal and partly blocked arteries, but not in~     arteries that are completely blocked. For this study, patients first have an MRI scan of~     their legs. During the scan, gadolinium contrast dye is injected into an arm vein. Then,~     during the catheterization procedure, a computer aligns the MRI pictures with the x-ray~     pictures to see if the combined images allow the doctor to better see where to place the~     catheters.~      Fusion of X-ray and MRI Images of the Heart~      For patients undergoing heart catheterization will undergo MRI and heart catheterization.~     Special plastic beads are taped to the chest to help compare the MRI and x-ray pictures.~     Patients first have an MRI scan of their heart. During the scan, gadolinium contrast dye is~     injected into an arm vein. Then, during the catheterization procedure, a computer aligns the~     MRI pictures with the x-ray pictures to see if the combined images allow the doctor to learn~     more about the pattern of heart disease.~      Heart rhythm, blood pressure, heart function, and breathing will be monitored during all the~     MRIs.~   "
267550|NCT00064883|"~     This study will: 1) provide standard non-experimental radiation therapy to children who have~     a form of cancer or similar disease process that is of scientific interest, importance, or~     educational value; 2) determine the effects of radiation on childhood cancers; and 3) allow~     for the education of nurses, medical students, residents, clinical fellows, and physicians in~     the management and care of this specialized group of cancer patients. Patients in this study~     will not receive experimental therapy, but will be given standard medical care.~      Patients eligible for this study include: 1) children with cancer or a precancer syndrome,~     such as aplastic anemia or other myelodysplastic syndrome, who are between 6 months and 21~     years of age and whose disease will be treated or has been treated with radiation therapy in~     the NCI's Radiation Oncology Branch (ROB); 2) patients with cancer or a precancer syndrome~     who have disease manifestations of special interest to ROB investigators; and 3) patients~     with cancer or a precancer syndrome who offer an important educational benefit to radiation~     oncology trainees and staff.~      Participants will undergo a medical history, physical examination, and blood tests, and~     radiation therapy. Before beginning treatment, medical information such as pathology reports,~     laboratory results, diagnosis and treatment history, scan results, and so forth, will be~     obtained from the patient's medical records. Additional procedures that may need to be done~     include scans, such as magnetic resonance imaging (MRI), computed tomography (CT), positron~     emission tomography (PET), lung function tests, arteriogram, or tumor biopsies.~      Participants will then have a (simulation) treatment planning session for radiation therapy~     during which measurements are taken, CT images are taken, and markings are placed on the body~     to help determine the treatment area. The radiation will be delivered to the body by a~     machine called a linear accelerator, which produces x-rays. Radiation therapy is generally~     given once or twice a day 5 days a week. Each treatment takes about 10 minutes.~      When the course of treatment is completed, patients return to the Radiation Oncology clinic~     for follow-up visits that include blood tests, a physical examination, and review of~     symptoms, if any. Visits are kept to a minimum, but continue for a prolonged period to watch~     for any late effects of treatment that may occur over a period of decades.~   "
267551|NCT00064844|"~     The overall objective of the study is to develop recommendations for treatment programs to~     help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers~     will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco~     treatment program. The 175 patients will be divided into two groups. One group will receive~     an active nicotine patch and active nicotine gum. The other group will receive an active~     nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year~     from the beginning of treatment.~   "
267552|NCT00064831|"~     The purpose of the study is to determine if black cohosh extract (BCE) administration in~     symptomatic postmenopausal women results in estrogenic stimulation of the breast, as~     determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.~   "
267553|NCT00064818|"~     The purpose of this study is to investigate the effect of acupuncture needling on connective~     tissue using ultrasound techniques both in animals and in humans.~   "
267554|NCT00064805|"~     Adults who sustain brain damage due to stroke, head injury, or traumatic surgery may develop~     difficulty reading. This study examines the effectiveness of behavior-based programs to~     improve reading ability in these individuals.~   "
267555|NCT00064779|"~     The experimental anti-cancer drug IL13-PE38QQR, which is being developed for the treatment of~     malignant brain tumors, is composed of parts of two proteins: the immune system cytokine IL13~     and a toxin from the bacterium Pseudomonas aeruginosa. The IL13 part of the drug binds to~     another protein, the IL13 receptor, when this receptor is displayed on the outside surface of~     cells. Cells with drug bound to the IL13 receptor take up the drug, and the toxin part of the~     drug then kills those cells. Since brain tumor cells display the IL13 receptor, they are~     potential targets that may be killed by this drug. This is a pilot study to visualize the~     distribution of IL13-PE38QQR infused into and around brain tumor tissue before and after~     surgical removal of the tumor in adult patients with recurrent malignant glioma.~      Stored tumor tissue will be tested for presence of the receptor protein, which is required~     for study entry. Eligible patients will then undergo biopsy to confirm the diagnosis of~     recurrent malignant glioma. IL13-PE38QQR will be infused for 96 hours into and around tumor~     tissue through catheters that have been placed surgically. For the first 48 hours the drug~     will be mixed with a radioactive tracer, so that the distribution of the drug can be followed~     by a type of scanning called SPECT. Surgery to remove the tumor will be performed~     approximately 15 days after the end of the infusion. Catheters will again be placed~     surgically, and IL13-PE38QQR will be infused a second time for 96 hours. Radioactive tracer~     will be included in the infusion for the first 48 hours. For both infusions, SPECT scans will~     be taken at 6, 24, and 48 hours after the start of infusion. MRI scans will be taken within~     90 minutes of the 24 and 48 hour SPECT scans. Patients will be followed closely with further~     scans and laboratory tests until completion of the study approximately 58 days after~     completion of the second infusion.~   "
267556|NCT00064766|"~     Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients~     using progestin-only hormonal contraception such as levonorgestrel implants (Norplant).~     Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease,~     may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This~     study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using~     Norplant.~   "
267557|NCT00064753|"~     The purpose of this randomized clinical trial is to determine if lowering homocysteine levels~     in renal transplant recipients with a multivitamin will reduce the occurrence of~     cardiovascular disease outcomes.~   "
267558|NCT00003712|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have~     advanced solid tumors.~   "
267559|NCT00003707|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in~     treating patients with advanced cancer.~   "
267560|NCT00003645|"~     RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy~     using leuprolide and flutamide may fight prostate cancer by reducing the production of~     testosterone. It is not yet known whether receiving leuprolide and flutamide is more~     effective than receiving no further therapy.~      PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in~     treating patients who have stage I or stage II prostate cancer that is at high risk of~     recurrence and who have already undergone surgery.~   "
267561|NCT00003571|"~     RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors~     improve methods of treating patients with colon cancer.~      PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon~     cancer.~   "
267562|NCT00003382|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of~     gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or~     fallopian tube cancer.~   "
267563|NCT00064792|"~     This study will evaluate the safety and effectiveness of simvastatin in treating children~     with Smith-Lemli-Opitz syndrome (SLOS). Patients with this inherited disease are deficient in~     an enzyme that converts a substance called 7-dehydrocholesterol (7-DHC) to cholesterol.~     Cholesterol synthesis is impaired, causing birth defects and mental retardation. This study~     will examine whether simvastatin can increase the amount of the deficient enzyme, thereby~     lowering 7-DHC and increasing cholesterol. It will examine the safety of simvastatin in~     affected children and its effects on their behavioral problems.~      Children between 4 and 18 years of age with mild to typical SLOS may be eligible for this~     study. Participants will be evaluated at the NIH Clinical Center in Bethesda, MD, and at the~     Kennedy Krieger Institute in Baltimore, MD, upon admission to the study and again at 6, 12,~     20, and 26 months. The visits will last 3 to 4 days, and will include a medical history and~     physical examination, photographs to document medical findings, and other procedures detailed~     below. In addition, blood samples will be collected at 1, 3, 9, 14, 15, 17, and 23 months.~     Parents will complete several questionnaires during the study. Procedures include the~     following:~        -  Simvastatin and cholesterol supplementation therapy. Patients take cholesterol~          supplements (50 milligrams per kilogram per day) plus simvastatin (0.5 mg/kg/day for 6~          weeks and then 1 mg/kg/day) for 12 months, and cholesterol supplements plus a placebo~          for 12 months.~        -  Blood draws to check liver, muscle, and kidney function, hormone levels, vitamin D~          levels, blood counts, cholesterol and 7-DHC levels, and lipoprotein levels. Some extra~          blood is drawn for research purposes.~        -  Urine collection. Urine is collected using a toilet hat. For children who are not toilet~          trained, urine is collected in a bag taped to the skin with an adhesive.~        -  Electroretinogram (ERG) to measure the function of the retina, the light-sensitive~          tissue at the back of the eye. ERG is done under sedation. After adapting the child's~          eyes to the dark, an electrode is taped to the child's forehead, the surface of one eye~          is numbed with eye drops, and a contact lens is placed on the eye. The child looks~          inside a globe that emits a series of light flashes. The contact lens senses electrical~          signals generated by the retina when the light flashes. After the ERG, the patient has a~          full eye exam, including pupil dilation and photographs of the eye.~        -  Lumbar puncture (spinal tap) to collect a sample of cerebral spinal fluid (CSF). This~          procedure, done while the patient is sedated for the ERG, shows whether simvastatin~          affects brain cholesterol and chemical levels. Under local anesthetic, a needle is~          inserted in the space between the bones in the lower back where the CSF circulates below~          the spinal cord. A small amount of fluid is collected through the needle.~        -  CRH stimulation test to detect hormone-related problems in cholesterol synthesis. The~          patient is given CRH, a hormone involved in cholesterol synthesis, through a plastic~          tube placed in a vein. Blood samples are collected through the same catheter to measure~          levels of other hormones involved in cholesterol production.~        -  Electroencephalogram (EEG) to look at the electrical activity (brain waves) of the~          child's brain.~        -  Activity monitoring. An activity monitor, which looks like and is worn like a watch, is~          used to record the child's level of activity for a 48-hour period.~        -  Urine pregnancy test at every visit for female patients over age 10.~        -  Skin swab for sterol (solid alcohol, such as cholesterol) analysis. An alcohol pad is~          rubbed lightly against the child's arm or thigh to collect skin cells.~        -  Stool collection. A small stool sample is collected from the child's diaper or, for~          children who are toilet trained, from a toilet hat like that used to collect urine.~   "
267564|NCT00064740|"~     Advances in treatment has turned HIV/AIDS into a chronic illness. Relaxation response is a~     state in which individuals evoke a bodily calm, effecting physiological changes that are~     shown to be associated with improved immune functioning. Acupuncture and relaxation are~     thought to both induce calm and deep relaxation in mind and body. This trial will study the~     combined effects of acupuncture and relaxation response in HIV patients.~   "
267565|NCT00064701|"~     The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate~     mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney~     transplant recipients.~   "
267566|NCT00064688|"~     To search for the genetic cause of the metabolic syndrome, a lipid disorder that poses a~     major risk for coronary heart disease.~   "
267567|NCT00064675|"~     To evaluate individual differences in cardiovascular responses to acute stress in Black~     adolescents.~   "
267568|NCT00006073|"~     This study will evaluate healthy normal volunteers and patients with a variety of endocrine~     disorders to 1) learn more about conditions that affect the endocrine glands (glands that~     secrete hormones) and 2) train physicians in endocrinology.~      Patients with endocrine-related conditions and healthy volunteers of all ages may be eligible~     for this study.~      All participants will have a physical examination medical and history. They may be required~     to provide blood, saliva or urine samples and undergo ultrasound (using sound waves) or~     magnetic resonance (using a magnetic field) imaging to visualize internal body structures.~      Some healthy adult volunteers will have hormone-stimulating tests to assess endocrine~     function. These tests measure blood hormone levels before and after injection of a synthetic~     form of a hormone. A device called a heparin lock, through which the hormone is injected and~     the blood samples are collected, is placed in a vein in the arm or hand. Blood samples are~     drawn before the hormone is injected and at various intervals after the injection to measure~     levels of the hormone. These tests, which last from 1 to 3 hours, may include the following:~        1. CRH stimulation test corticotropin-releasing hormone is given to test pituitary and~          adrenal gland function~        2. ACTH stimulation test adrenocorticotrophic hormone is given to test adrenal gland~          function~        3. LHRH stimulation test luteinizing hormone-releasing hormone is given to test pituitary~          gland function~        4. TRH stimulation test thyroid-releasing hormone is given to test pituitary and thyroid~          gland function~        5. GHRH stimulation test growth hormone releasing hormone is given to measure growth~          hormone levels.~      An oral glucose tolerance test, which is similar to the stimulation tests, may also be done~     to measure blood glucose (sugar) and insulin levels after drinking a sugary liquid.~      Healthy volunteers and patients with a hereditary endocrine disorder and their family members~     may also be asked to provide a blood sample for genetic studies of inherited endocrine~     disorders. Patients with endocrine-related disorders may be offered medical or surgical~     treatment for their disorder.~      AcAccess http://turners.nichd.nih.gov/ for additional study publications.~   "
267569|NCT00064727|"~     This study will evaluate the safety and effectiveness of the drug rosiglitazone for improving~     heart function in patients with heart failure and glucose intolerance or type II~     (adult-onset) diabetes, or both. Because of a lowered sensitivity to the hormone insulin,~     patients with type II diabetes or glucose-intolerance do not regulate glucose (sugar)~     effectively. Rosiglitazone is used to treat type II diabetes, but it is not commonly given to~     patients with heart failure because it can cause leg swelling and, rarely, pulmonary edema.~     However, patients with heart failure who also have glucose intolerance or type II diabetes~     generally fare worse than those with heart failure alone, and therapies that decrease insulin~     resistance may be beneficial to these patients.~      Patients 21 years of age and older with heart failure and type II diabetes or glucose~     intolerance, or both, may be eligible for this study. Patients must be stable on current~     therapy for heart failure and must not have any planned surgeries for coronary artery~     disease. Candidates will be admitted to the NIH Clinical Center for from 2 to 7 days for~     screening procedures, which include a medical history and physical examination, blood and~     urine tests, electrocardiogram (ECG), chest x-ray, magnetic resonance imaging (MRI), exercise~     testing, and echocardiography (ultrasound test of the heart).~      Participants will be randomly assigned to receive either rosiglitazone or placebo (an~     identical-looking pill with no active ingredient). They will take one tablet a day for the~     first month, one tablet twice a day for the second month, and then two tablets twice a day~     from the third month to the end of the study at 6 months. During the treatment period,~     patients will have a history, physical examination, and blood tests every 4 weeks, exercise~     testing and echocardiography at 3 and 6 months, and urinalysis, electrocardiogram and MRI at~     6 months. To check for fluid accumulation in the legs or lungs, patients will report their~     weight and symptoms every 2 weeks throughout the study. After the 6-month treatment period,~     patients will be put back on the diabetes medicines they were taking before the study. Their~     physicians will be notified of possible modifications in treatment for maintaining optimum~     glucose tolerance.~      Six months after completing treatment (one year after beginning the study), patients will~     return to the Clinical Center for blood tests to measure the long-term effects of~     rosiglitazone and to evaluate progress. They will then be invited to return to the clinic for~     annual checkups, if possible, or for yearly follow-up by mail or telephone to review their~     health status.~   "
267605|NCT00064285|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes~     necessary for cancer cell growth. Drugs used in chemotherapy such as flavopiridol use~     different ways to stop cancer cells from dividing so they stop growing or die. Combining~     imatinib mesylate with flavopiridol may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol and~     imatinib mesylate in treating patients with hematologic cancer.~   "
267570|NCT00064714|"~     This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the~     ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on~     beta cell function.~      Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells~     of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve~     the pancreas's ability to produce insulin and help control blood sugar, but it may also~     activate the original immune response that caused the diabetes. Thus, this study will examine~     the effects of AC2993 alone as well as in combination with immunosuppressive drugs.~      Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for~     this 20-month study. They must have had diabetes for at least 5 years and require insulin~     treatment. Candidates will be screened with a questionnaire, followed by medical history and~     physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis,~     electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below).~     Participants will undergo the following tests and procedures:~      Advanced screening phase: Participants undergo a diabetes education program, including~     instruction on frequent blood glucose monitoring, dietary education on counting~     carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar~     (hypoglycemia), and potential treatment with glucagon shots.~      Patients must administer insulin via an insulin pump or take at least four injections per day~     including glargine (Lantus) insulin.~      4-month run-in phase~        -  Arginine-stimulated C-peptide test: This test measures the body's insulin production.~          The patient is injected with a liquid containing arginine, a normal constituent of food~          that increases insulin release from beta cells into the blood stream. After the~          injection, seven blood samples are collected over 10 minutes.~        -  Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response~          of the beta cells to an ordinary meal and the time it takes for food to pass through the~          stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood~          samples are then drawn through a catheter (plastic tube placed in a vein) every 30~          minutes for 4 hours to measure levels of various hormones and the concentration of~          acetaminophen.~        -  Euglycemic clamp: This test measures the body's level of insulin resistance by measuring~          the amount of glucose necessary to compensate for an increased insulin level while~          maintaining a prespecified blood glucose level.~   "
267571|NCT00064662|"~     The primary aim of this clinical trial is to compare the treatment success for two surgical~     procedures that are frequently used and have similar cure rates, yet have not been compared~     directly to each other in a large, rigorously conducted randomized trial. The secondary aims~     of the trial are to compare other outcomes for the two surgical procedures, including quality~     of life, sexual function, satisfaction with treatment outcomes, complications, and need for~     other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four~     years.~   "
267572|NCT00064649|"~     The primary objective of this randomized clinical trial is to determine the efficacy and~     safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle~     ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin~     and finasteride.~   "
267573|NCT00064636|"~     The purpose of this study is to evaluate how safe VELCADE (PS-341) is when given with~     Taxotere (Docetaxel) to patients with non-small cell lung cancer or other solid tumors, and~     also to see what effects (good and bad) it has on you and your cancer.~   "
267574|NCT00064623|"~     The purpose of the study is to determine if an investigational drug, NGX-4010~     (high-concentration capsaicin patch), is effective in treating painful HIV-associated~     neuropathy.~   "
267575|NCT00064610|"~     The purpose of this study is to evaluate how safe PS-341(VELCADE) is when given with~     Docetaxel (Taxotere) to patients with androgen-independent prostate cancer, and also to see~     what effects (good and bad) it has on you and on your cancer.~   "
267576|NCT00064597|"~     This purpose of this study is to develop noninvasive methods of prenatal diagnosis. Fetal~     cells can be found in maternal blood. This study is designed to isolate these fetal cells~     from a sample of the pregnant woman’s blood and use those cells to test for fetal chromosome~     abnormalities.~   "
267577|NCT00063726|"~     The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection~     who experienced progressive disease(PD) while receiving high-dose dexamethasone from the~     M34101-039 study.~   "
267578|NCT00003350|"~     Randomized phase III trial to compare the effectiveness of paclitaxel with that of~     doxorubicin in treating patients who have advanced AIDS-related Kaposi's sarcoma. Drugs used~     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether paclitaxel is more effective than doxorubicin in treating~     patients with advanced AIDS-related Kaposi's sarcoma~   "
267579|NCT00003184|"~     RATIONALE: Vaccines made from breast cancer cells may make the body build an immune response~     to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccines made from breast cancer cells~     in treating women with metastatic breast cancer.~   "
267580|NCT00003045|"~     Hyperthermia therapy may kill prostate cancer cells by heating them to several degrees above~     body temperature. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining~     hyperthermia with radiation therapy may kill more tumor cells.~      The purpose of this study is to determine the ability of hyperthermia when combined with~     radiation therapy and in some patients hormonal therapy to control prostate cancer.~   "
267581|NCT00003008|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with~     AIDS-related Kaposi's sarcoma.~   "
267582|NCT00002965|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating patients~     with recurrent unresectable meningiomas and malignant meningiomas.~   "
267583|NCT00064584|"~     This is the first study of the drug CT53518 when given to humans. The purpose of this study~     is to determine the highest dose of CT53518 that can safely be given to patients with Acute~     Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug.~     The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body.~     Additionally, the study will evaluate the effects of the drug on a specific type of cell in~     bone marrow and blood, known as a blast.~   "
267606|NCT00064272|"~     RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients~     receiving chemotherapy for cancer.~      PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or~     preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.~   "
267607|NCT00064259|"~     Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop~     tumor cells from dividing so they stop growing or die. Oblimersen may increase the~     effectiveness of chemotherapy by making tumor cells more sensitive to the drugs. This phase~     I/II trial is studying the side effects and best dose of oblimersen when given with cisplatin~     and fluorouracil and to see how well they work in treating patients with locally advanced,~     recurrent, or metastatic cancer of the esophagus, gastroesophageal junction, or stomach.~   "
267584|NCT00064571|"~     Unilateral vocal fold paralysis (UVFP) is caused by injury to the nerve to the affected vocal~     fold. The injury to the vocal fold makes the affected person's voice sound breathy. Voice~     therapy is usually tried first, and, if unsuccessful, surgical treatment is considered. The~     standard surgical treatment is called vocal fold medialization and aims to bring the injured~     cord to the midline. An alternative surgical treatment, vocal fold reinnervation, aims to~     bring a new nerve supply to the injured vocal fold. The reinnervation operation, which has~     some potential advantages over the medialization operation also requires several months for~     final results to be gained. The goal of this multicenter, randomized clinical trial is to see~     which of the two surgical treatments produces a better outcome.~      In order to participate in this study patients with UVFP must meet all entry criteria and~     must be released from voice therapy by a speech-language pathologist. Information collected~     for the study (pre-surgery, and at 6 and 12 months after surgery) includes voice recordings,~     movies made of vocal fold function, airflow and pressure measurements of the voicebox, and an~     outcomes questionnaire.~   "
267585|NCT00064558|"~     To evaluate whether genetic variation in selected candidate genes is associated with risk of~     sudden cardiac death in the general population.~   "
267586|NCT00064545|"~     To evaluate common genetic variations, that in combination with exposure to tobacco smoke,~     may modify the risk of atherosclerosis.~   "
267587|NCT00064532|"~     To assess the associations of serum sex hormones with the presence and progression of~     subclinical atherosclerosis.~   "
267588|NCT00064519|"~     To investigate the genetics of C reactive protein in families with myocardial infarction.~   "
267589|NCT00064506|"~     To assess genetic variation in 87 different cardiovascular disease candidate genes and to~     measure the associations of these variants with cardiovascular disease and its risk factors.~   "
267590|NCT00064493|"~     To identify genetic variation in reverse cholesterol transport (RCT) and its role in~     cardiovascular disease and atherosclerosis.~   "
267591|NCT00064480|"~     To conduct a person-level meta-analysis by pooling 9 United States studies with both black~     and white cohorts.~   "
267592|NCT00064467|"~     This is a study of Major Depressive Disorder (MDD) in patients with decreased energy,~     pleasure and interests.~   "
267593|NCT00064454|"~     The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535~     compared to a placebo in patients with active Ulcerative Colitis.~      Depending on their response, participants will be offered the investigational medication for~     up to one year after the study's completion at select sites.~   "
267594|NCT00064441|"~     The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535~     compared to a placebo in patients with active Ulcerative Colitis.~      Depending on their response, participants will be offered the investigational medication for~     up to one year after the study's completion at select sites.~   "
267595|NCT00064415|"~     The purpose of this study is to determine the long-term safety of arformoterol over a period~     of 12 months in subjects with COPD~   "
267596|NCT00064402|"~     The purpose of this study is to assess the bronchodilator effect and safety of multiple daily~     doses of arformoterol administered for 12 weeks as maintenance treatment in patients with~     COPD~   "
267597|NCT00064389|"~     The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic~     albuterol based on the frequencies of adverse events reporting during a 12-month period of~     chronic dosing of adolescent and adult subjects with asthma.~   "
267598|NCT00064376|"~     RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop~     into normal bone marrow cells.~      PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who~     have myelodysplastic syndrome.~   "
267599|NCT00064363|"~     RATIONALE: Drugs used in chemotherapy such as talampanel use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well talampanel works in treating patients with~     recurrent, progressive high-grade glioma.~   "
267600|NCT00064350|"~     RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in~     vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different~     human tumor types including colon, pancreatic, lung, and ovarian. This activity was~     cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is~     suspended while the drug is administered but returns to baseline rates when the agent is~     withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the~     activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized~     discontinuation design was adopted in the present trial, conducted in a population who were~     potentially sensitive to sorafenib.~      PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works~     compared to placebo in treating patients with refractory non-small cell lung cancer.~   "
267601|NCT00064337|"~     RATIONALE: Drugs used in chemotherapy such as melphalan work in different ways to stop cancer~     cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral~     stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and~     kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving melphalan together with autologous~     stem cell transplantation works in treating patients with multiple myeloma or primary~     systemic amyloidosis.~   "
267602|NCT00064324|"~     Phase II trial to study the effectiveness of perifosine in treating patients who have~     advanced soft tissue sarcoma. Drugs used in chemotherapy such as perifosine use different~     ways to stop tumor cells from dividing so they stop growing or die.~   "
267603|NCT00064311|"~     RATIONALE: Antifungals such as ravuconazole may be effective in preventing fungal infections~     in patients undergoing chemotherapy and stem cell transplantation.~      PURPOSE: Phase I/II trial to study the effectiveness of ravuconazole in preventing fungal~     infections in patients undergoing allogeneic stem cell transplantation.~   "
267604|NCT00064298|"~     RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the~     development or recurrence of cancer. Fruit and vegetable extracts may be effective in~     preventing the recurrence or further development of head and neck cancer.~      PURPOSE: This randomized phase II trial is studying how well fruit and vegetable extracts~     work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB~     head and neck cancer.~   "
267608|NCT00064246|"~     Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan~     with rituximab in treating patients who have localized or recurrent lymphoproliferative~     disorder after an organ transplant. Monoclonal antibodies such as yttrium Y 90 ibritumomab~     tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive~     cancer-killing substances to them without harming normal cells~   "
267609|NCT00064233|"~     RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary~     for cancer cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in~     treating patients with chronic phase chronic myelogenous leukemia that is resistant to~     imatinib mesylate.~   "
267610|NCT00064220|"~     RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who~     have advanced or metastatic soft tissue sarcoma.~   "
267611|NCT00064207|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after~     surgery may kill any tumor cells that remain after surgery. It is not yet known whether~     giving gemcitabine together with radiation therapy is more effective than gemcitabine alone~     following surgery in treating pancreatic cancer.~      PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together~     with radiation therapy works and compares it to gemcitabine alone in treating patients who~     have undergone surgery for pancreatic cancer.~   "
267612|NCT00064194|"~     RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the~     development or recurrence of cancer. Vitamin E, selenium, and soy protein may be effective in~     preventing the development of prostate cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of combining vitamin E,~     selenium, and soy protein in preventing prostate cancer in patients who have high-grade~     prostate neoplasia.~   "
267613|NCT00064181|"~     RATIONALE: Drugs used in chemotherapy such as irinotecan, capecitabine, leucovorin, and~     fluorouracil use different ways to stop tumor cells from dividing so they stop growing or~     die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor.~     It is not yet known which combination chemotherapy regimen with or without celecoxib is more~     effective in treating metastatic colorectal cancer.~      PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens~     and celecoxib to see how well they work compared to two combination chemotherapy regimens~     alone in treating patients with metastatic colorectal cancer.~   "
267614|NCT00064142|"~     This phase II trial studies how well halofuginone hydrobromide works in treating patients~     with human immunodeficiency virus (HIV)-related Kaposi's sarcoma. Halofuginone hydrobromide~     ointment may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.~   "
267615|NCT00064129|"~     This phase I trial is studying the side effects and best dose of ipilimumab when given with~     sargramostim in treating patients with metastatic prostate cancer. Monoclonal antibodies can~     locate tumor cells and either kill them or deliver tumor-killing substances to them without~     harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system kill more tumor cells.~   "
267616|NCT00064116|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells~     and either kill them or deliver cancer-killing substances to them without harming normal~     cells. It is not yet known whether combination chemotherapy is more effective with or without~     rituximab in treating patients with non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying four different combination chemotherapy~     regimens and rituximab to see how well they work compared to four different combination~     chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.~   "
267617|NCT00064103|"~     This phase I/II trial is studying the side effects and best dose of gene therapy and to see~     how well it works in preventing cancer in patients with premalignant carcinoma of the oral~     cavity or pharynx. Inserting the p53 gene into a person's tumor cells may improve the body's~     ability to kill the tumor cells~   "
267618|NCT00064090|"~     RATIONALE: Drugs used in chemotherapy such as cytarabine use different ways to stop cancer~     cells from dividing so they stop growing or die. 3-AP may stop the growth of cancer cells by~     blocking the enzymes necessary for cancer cell growth and may help cytarabine kill more~     cancer cells by making them more sensitive to the drug.~      PURPOSE: Phase I trial to study the effectiveness of combining cytarabine with 3-AP in~     treating patients who have relapsed or refractory hematologic cancer.~   "
267619|NCT00064077|"~     This randomized phase III trial is studying four combination chemotherapy regimens using~     cisplatin to compare how well they work in treating women with stage IVB, recurrent, or~     persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel,~     vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing~     so they stop growing or die. It is not yet known which combination chemotherapy regimen~     containing cisplatin is most effective in treating cervical cancer.~   "
267620|NCT00064064|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor~     cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by~     blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more~     cancer cells by making them more sensitive to the drug.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in~     treating patients who have metastatic non-small cell lung cancer.~   "
267621|NCT00064051|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor~     cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by~     blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more~     cancer cells by making them more sensitive to the drug.~      PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works~     in treating patients with unresectable or metastatic pancreatic cancer.~   "
267647|NCT00042900|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have~     advanced cancer.~   "
267622|NCT00064038|"~     RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer~     cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple~     myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is~     more effective with or without lenalidomide in treating multiple myeloma.~      PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see~     how well they work compared to dexamethasone alone in treating patients with previously~     untreated stage I, stage II, or stage III multiple myeloma.~   "
267623|NCT00064025|"~     This phase II trial is studying how well medroxyprogesterone works in treating patients with~     endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not~     including the cervix). Hormone therapy using medroxyprogesterone may be effective in treating~     endometrioid cancer.~   "
267624|NCT00064012|"~     RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor~     cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer~     cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether~     bortezomib is more effective with or without docetaxel in treating patients with advanced~     non-small cell lung cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without~     docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV~     non-small cell lung cancer.~   "
267625|NCT00063999|"~     This randomized phase III trial compares how well two different combination chemotherapy~     regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and~     paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has~     come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride,~     cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. It is not yet known which combination chemotherapy regimen is more effective in~     treating endometrial cancer.~   "
267626|NCT00063986|"~     RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive~     types of surgery for esophageal cancer that may have fewer side effects and improve recovery.~      PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and~     video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for~     high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.~   "
267627|NCT00063973|"~     This phase I trial is studying the side effects and best dose of cilengitide in treating~     children with recurrent, progressive, or refractory primary CNS tumors. Cilengitide may slow~     the growth of brain cancer cells by stopping blood flow to the tumor.~   "
267628|NCT00063960|"~     RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways~     to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses~     a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and~     giving them in different ways may kill any tumor cells remaining after surgery.~      PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic~     arterial infusion with floxuridine after surgery in treating patients who have hepatic~     (liver) metastases from colorectal cancer.~   "
267629|NCT00063947|"~     This phase I trial is studying the side effects and best dose of erlotinib when given~     together with gemcitabine and radiation therapy in treating patients with locally advanced~     unresectable pancreatic cancer. Erlotinib may stop the growth of tumor cells by blocking the~     enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with gemcitabine~     may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.~   "
267630|NCT00063934|"~     This phase I/II trial is studying the side effects and best dose of oblimersen when given~     together with doxorubicin and docetaxel and to see how well they work in treating women with~     metastatic or locally advanced breast cancer. Drugs used in chemotherapy, such as doxorubicin~     and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing~     or die. Oblimersen may increase the effectiveness of doxorubicin and docetaxel by making the~     tumor cells more sensitive to the drugs.~   "
267631|NCT00063895|"~     This phase I/II trial is studying the side effects of erlotinib and to see how well it works~     in treating patients with metastatic or unresectable non-small cell lung cancer, ovarian~     cancer, or squamous cell carcinoma (cancer) of the head and neck. Erlotinib may stop the~     growth of tumor cells by blocking the enzymes necessary for their growth~   "
267632|NCT00063882|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.~     Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to~     kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy~     may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more~     effective with or without external-beam radiation therapy in treating prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial~     brachytherapy with or without external-beam radiation therapy in treating patients who have~     prostate cancer.~   "
267633|NCT00063869|"~     The objective of the study is to evaluate the safety and efficacy of etanercept in comparison~     with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic~     pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1~     year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary~     objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).~   "
267634|NCT00023907|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who~     have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.~   "
267648|NCT00040820|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Clinical trial to study the effectiveness of oxaliplatin in treating patients who~     have locally advanced or metastatic colorectal cancer that has been previously treated.~   "
267660|NCT00063635|"~     The purpose of this study is to determine if therapeutic modification of insulin resistance~     or oxidative stress leads to improvement in serum or histologic indicators of liver injury or~     quality of life.~   "
267635|NCT00005940|"~     This phase II trial studies how well iodine I 131 monoclonal antibody BC8, busulfan, and~     cyclophosphamide followed by donor stem cell transplant works in treating patients with acute~     myeloid leukemia that has decreased or disappeared, but the cancer may still be in the body.~     Giving chemotherapy drugs, such as busulfan and cyclophosphamide before a donor peripheral~     blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop~     the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled~     monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells~     and carry cancer-killing substances to them without harming normal cells. When the stem cells~     from a related donor, that closely matches the patient's blood, are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets.~   "
267636|NCT00003211|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy and radiation therapy with peripheral stem~     cell transplantation may allow the doctor to give higher doses of chemotherapy or radiation~     therapy and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with topotecan,~     cyclophosphamide, cisplatin, and vincristine plus radiation therapy and peripheral stem cell~     transplantation in treating children with newly diagnosed medulloblastoma or supratentorial~     primitive neuroectodermal tumor.~   "
267637|NCT00002878|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining PSC~     833 with chemotherapy may reduce resistance to the drug, and allow more tumor cells to be~     killed. It is not yet known whether combination chemotherapy plus PSC 833 is more effective~     than combination chemotherapy alone in treating patients with relapsed or refractory multiple~     myeloma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without PSC 833 in treating patients with relapsed or refractory multiple myeloma.~   "
267638|NCT00063856|"~     The primary purpose of this study is to find out the risk of spreading the vaccine virus,~     vaccinia, from the smallpox vaccination site when different types of bandages are used to~     cover the site. The study will also look at how each bandage type affects the healing of the~     sore. Study participants will include healthy individuals, 18-50 years old, who have not~     previously received a smallpox vaccine and healthy individuals, 18-50 years old, who have~     received a previous smallpox vaccine. All participants will receive the smallpox vaccine and~     be randomly assigned to 1 of 3 different bandage groups to cover the vaccine site: standard~     gauze dressing attached with paper tape, Opsite gauze-impregnanted occlusive dressing~     (attached by paper tape and waterproof), and Allevyn hydropolymer dressing (which is~     self-adhesive and highly absorbent). Volunteers will be involved in study related procedures~     for up to 252 days.~   "
267639|NCT00063843|"~     The primary objective is to determine the tolerability and safety, from days 0 to 210, of~     escalating doses of rPA either with or without Alhydrogel (an adjuvant; used to increase the~     action of the principle drug) given in a two-dose, intramuscular regimen to health adults.~     The secondary objective is to evaluate antibody responses to rPA, from days 0 to 210,~     following one of four escalating doses of vaccine given with and without Alhydrogel given in~     a two-dose series to healthy adults, and to compare immune responses following rPA with those~     following BioThrax (tm) given by either the intramuscular or SQ route. The tertiary objective~     is to describe the antibody kinetics following vaccination. This information will be used to~     determine the most probable optimal dose of rPA and/or Alhydrogel that is safe, well~     tolerated, and maximally immunogenic for use in future phase II trials.~   "
267640|NCT00063830|"~     This is a multi-center trial in the US and Europe to test the safety, efficacy and~     tolerability of alicaforsen (ISIS 2302), a new type of drug called an antisense drug, in~     patients with mild to moderate active Ulcerative Colitis (UC). Alicaforsen is designed to~     reduce the production of a specific protein, called ICAM-1, a substance that plays a~     significant role in the increase of inflammation and is likely to be involved in inflammatory~     bowel diseases such as ulcerative colitis. The ISIS 2302-CS27 study will compare four dosing~     regimens and determine the minimum effective dose of alicaforsen enema in UC patients over~     six weeks as compared to a placebo enema. (The probability of receiving active formulation is~     4:1). The primary objective of this study is to evaluate the percentage reduction in DAI at~     Week 6.~   "
267641|NCT00063817|"~     This study will examine the safety and effectiveness of a combination kidney and bone marrow~     transplant from a relative with the same (or nearly the same) blood cell type as the~     transplant recipient. An investigational medication will be given prior to and after the~     transplant to help protect the transplanted kidney from attack by the body's immune system.~   "
267642|NCT00063804|"~     Most currently approved anti-HIV drugs work by stopping the replication of HIV after it has~     entered cells. AMD070 (also known as AMD11070) is designed to block HIV from entering cells~     and may be effective in treating patients who have developed resistance to or are unable to~     take other anti-HIV drugs. This study will evaluate the safety of different doses of AMD070~     along with AMD070 boosted with ritonavir (RTV) in HIV uninfected men.~   "
267643|NCT00063791|"~     The purpose of this study is to give patients who have had 4 or more prior lines of therapy~     for multiple myeloma access to VELCADE. The study is for patients who are not eligible for~     other clinical trials with VELCADE and for who VELCADE would otherwise not be available.~   "
267644|NCT00063778|"~     The purpose of this study is to see if different doses of an experimental HIV vaccine are~     safe and to study how the immune system responds to the vaccine. The vaccine will be tested~     in healthy, HIV uninfected volunteers. AVX101 contains only one of the many substances that~     HIV needs to make more copies of itself; therefore, the vaccine cannot cause HIV or AIDS.~   "
267645|NCT00063752|"~     The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus~     vulgaris is safe.~   "
267646|NCT00045357|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     tumor cells from growing. Treating a person's white blood cells in the laboratory and~     reinfusing them may cause a stronger immune response and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients~     who have metastatic melanoma.~   "
267652|NCT00002752|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody~     therapy in treating patients who have primary or metastatic brain cancer.~   "
267653|NCT00002582|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination~     chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or~     die. Combining hormone therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without~     chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA~     breast cancer.~   "
267654|NCT00063765|"~     This study will evaluate the safety of a ciliary neurotrophic factor (CNTF) implant placed in~     the eye to allow the release of CNTF directly on the retina. The results of this study may~     lead to a larger investigation of CNTF implants to treat retinitis pigmentosa (RP), a~     progressive degenerative eye disease that begins with loss of peripheral vision and night~     blindness and often leads to blindness in later life.~      Currently, there are no effective treatments for RP. Researchers have found, however, that~     certain proteins, called ciliary neurotrophic factor (CNTF), can partially protect cells in~     the eye if given directly inside the eye. A major challenge in treating RP is to deliver~     medicine directly into the eye. One way to ensure that CNTF gets into the eye is to~     surgically place an implant inside the eye to release the protein.~      Patients 18 years of age and older with retinitis pigmentosa whose visual acuity is 20/100 or~     worse may be eligible for this study. Candidates will be screened with a medical history,~     physical examination, eye examinations, and eye photographs. The eye examination includes~     measurement of visual acuity and eye pressure, examination of the pupils and eye movements,~     and examination of the lens and back of the eye. In addition, patients will have the~     following tests:~        -  Visual field test: Patients look at a central spot on a white screen and tell the~          examiner whenever they see a small light appear at other places on the screen.~        -  Electroretinogram (ERG): Electrodes are taped to the patient's forehead. Special contact~          lenses are placed on the eyes, similar to normal contact lenses, after the eye has been~          numbed with drops. The contact lenses sense small electrical signals generated by the~          retina. The ERG measures the electrical activity of the retina when it is stimulated by~          light. For the ERG recording, the patient looks inside a large, hollow, dark sphere, and~          sees flashes of light, first in the dark, and then with a light turned on in the sphere.~        -  Optical coherence tomography: This test, done with the machine used to examine the eye,~          measures retinal thickness by producing cross-sectional pictures of the retina.~      Participants undergo surgery at the NIH Clinical Center in a 30-minute operation to place the~     implant in one eye. The surgery is done under local anesthetic. Before the procedure,~     patients are given a steroid injection along side the eye to minimize inflammation after~     surgery. Following the procedure, patients return for follow-up visits once a month for 6~     months. At these visits, several of the exams described above are repeated to evaluate~     treatment effects and check for adverse side effects. After 6 months, the implant is~     surgically removed. Post-surgical care for both implant and explant surgeries include~     examinations the day and week after surgery to examine the wound, a high dose of steroid~     immediately after surgery, oral antibiotics for 7 days, and eye drops for 1 week to prevent~     infection and inflammation.~   "
267655|NCT00063713|"~     The purpose of this study is to find out whether treatment with VELCADE will increase the~     time it takes for lymphoma to get worse.~   "
267656|NCT00063700|"~     This pilot study on the impact of a non-commercialism policy in Seattle schools will assess~     and evaluate obesity-related health outcomes of a real-life policy decision, recently voted~     on and adopted by the Seattle School Board. The policy reduces the exposure to advertising~     and other marketing pressures, including those from commercial food vendors.~   "
267657|NCT00063687|"~     The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and~     safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial~     in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient~     Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and~     hospitalization) will be assessed as a composite endpoint in this trial.~   "
267658|NCT00063674|"~     Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls.~      The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled~     to tripled in the past two decades, with the highest rates among poor and ethnic minority~     girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in~     overweight children, and more children are manifesting precursors of heart disease and~     stroke.~      Our Two Approaches:~        1. A state-of-the-art nutrition education program with monthly newsletters mailed to girls~          and their parents and quarterly evening lectures/educational events at school sites,~          including cooking demonstrations and games to improve nutrition and increase physical~          activity.~        2. After-school dance classes held five days per week all year long at school sites from~          the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised~          homework study hall each day, and emphasize both traditional ethnic dances and popular~          dance.~      Participants: Second, third and fourth grade girls and their families will be eligible to~     participate. All activities are free of charge. To be able to perform a valid evaluation, to~     be able to accommodate all girls at their own school, and to be fair about which girls~     receive which program, families who wish to participate will be randomly selected to~     participate in either one program or the other (nutrition education or dance classes). Each~     family will participate for two years.~      Evaluation: Trained Stanford staff will perform all evaluation procedures with participating~     families in their own homes at the beginning and every six months. Families will be~     compensated for their participation.~   "
267659|NCT00063648|"~     Despite advances in medical and gene therapy, orthotopic liver transplantation remains the~     only definitive therapeutic option for children with end-stage liver disease. Recent advances~     in pre-, intra-, and early post-transplant care have resulted in a dramatic improvement in~     survival of the pediatric liver transplant patient. The broad long-range goal of our research~     program is directed at enhancing the patient's long-term survival. Our primary focus relates~     to obligate life-long immunosuppression, with its inherent complications including severe~     infection and development of cancer. These two complications come together in a single~     disease, Epstein-Barr Virus (EBV)- associated post-transplant lymphoproliferative disorder~     (PTLD). EBV, a latent human lymphotrophic herpes virus infects and immortalizes B cells.~     Primary infection usually occurs via salivary exchange and results in a mild, self-limited~     illness followed by life-long EBV-specific T cell controlled EBV latency. T cell-based~     immunosuppression prevents allograft rejection, however, it also suppresses cytotoxic T~     lymphocyte (CTL) function, generating an environment in which EBV-infected cells can~     proliferate. Patients receiving life-long T cell-based immunosuppression have an increased~     risk of developing PTLD due to their inability to produce normal immunoregulatory responses.~     This disease is particularly devastating to the pediatric patient as its incidence is at~     least 4-fold greater than in the adult liver transplant patient population. In fact, PTLD is~     the number one cause of death following pediatric liver transplantation. At this time, there~     is no definitive method of prospectively detecting, diagnosing, or treating PTLD, and current~     treatment protocols place the liver allograft and patient at risk. Therefore, a diagnostic~     tool that is both sensitive and specific, and a treatment strategy with low toxicity are~     greatly needed to decrease the morbidity and mortality suffered by the pediatric liver~     transplant patient with PTLD. Our proposed studies will support our hypothesis that the~     combination of a persistently elevated EBV load in the setting of a diminished immune~     response to EBV will be an early risk indicator associated with PTLD development, and that~     pre-emptive treatment utilizing autologous adoptive EBV-specific CTL immunotherapy will~     provide a low toxicity treatment option.~   "
267662|NCT00063609|"~     The purpose of this study is to compare the effect of an investigational drug used~     intravenously and placebo administered every three months for one year, on bone loss~     associated with initial androgen deprivation) in men with prostate cancer without metastasis.~     In order to participate in this trial male patients must be 18 years of age or older and have~     been diagnosed with prostate cancer without metastasis and within one year of starting their~     androgen deprivation therapy at the day of randomization onto this trial. In addition,~     patients who have undergone a recent orchiectomy (orke-ek'te-me) (removal of one or two~     testes) are eligible to participate.~      Patients who received any prior bisphosphonate therapy or prior treatment with systemic~     corticosteroids within in the past 12 months are not eligible to participate. Also patients~     who are receiving treatment for osteoporosis are not eligible to participate.~      Inclusion into this clinical trial with this investigational drug is based on the protocol~     entry criteria and evaluation from a participating trial investigator.~   "
267663|NCT00063661|"~     Parkinson's disease patients usually have difficulty making automatic movements. Automatic~     movements are movements people often make without conscious thought.~      The purpose of this study is to investigate regions of the brain that affect automatic~     movements and to understand the movements of Parkinson's patients. Investigators hope this~     knowledge will lead to better treatment for the disease.~      Thirty participants will be enrolled in this study. Each will give a medical history and~     undergo a brief physical exam. Participants will have two MRI scans, each lasting~     approximately 1.5 hours. During these scans, they may be asked to move their right or left~     hands or to remember some letters that they have been shown. Before undergoing the second~     scan, participants will be asked to practice the tasks until they can perform them correctly.~   "
267664|NCT00063596|"~     Extremely low birth weight infants have decreased blood levels of Vitamin A. This Vitamin A~     deficiency may increase the risk of infections and chronic lung disease in these infants.~     This study will examine the effects of Vitamin A supplementation in premature babies born~     weighing less than 1500 grams (3.3 lbs).~   "
267665|NCT00063583|"~     The purpose of this study is to determine whether a new investigational drug, pirfenidone,~     will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is~     that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced~     kidney disease will lead to preservation of kidney function.~   "
267666|NCT00063570|"~     The purpose of the study is to determine if the two drugs can help patients feel better while~     causing the tumor to become smaller or disappear; evaluate the safety of giving both~     pemetrexed and gemcitabine in patients with advanced breast cancer.~   "
267667|NCT00063557|"~     To investigate if neighborhood characteristics are related to disease risk in a multiethnic~     cohort.~   "
267668|NCT00063544|"~     To measure associations between physical activity and obesity in a large, population-based~     cohort of children.~   "
267669|NCT00063531|"~     The purpose of this study is to compare two methods of diagnosing coronary artery disease~     (CAD), thallium single photon emission computed tomography (SPECT) and ultrafast computed~     tomography (CT).~   "
267670|NCT00063518|"~     To describe time trends in the epidemiology of venous thromboembolism.~   "
267671|NCT00063505|"~     To identify genes contributing to hypertension in African Americans by focusing on the~     physiological pathways that determine arterial pressure.~   "
267672|NCT00063492|"~     To determine the role of the angiotensinogen gene in human hypertension.~   "
267673|NCT00063323|"~     The purpose of this study is to determine the efficacy and cost-effectiveness of long-term~     pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate~     associated with stopping smoking.~   "
267674|NCT00033319|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of aspirin and/or folic acid may be effective in~     preventing recurrent polyps in patients who have had polyps removed previously.~      PURPOSE: Randomized clinical trial to determine the effectiveness of aspirin and/or folic~     acid in preventing the recurrence of colorectal polyps.~   "
267675|NCT00031954|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian~     tube, or peritoneal cancer that has not been previously treated.~   "
267676|NCT00031889|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using~     exemestane plus bicalutamide may fight prostate cancer by reducing the production of~     androgens. It is not yet known if exemestane is more effective with or without bicalutamide~     in treating prostate cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of exemestane with or without~     bicalutamide in treating patients who have stage IV prostate cancer that has been previously~     treated with hormone therapy or surgery.~   "
267677|NCT00031668|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known if giving radiation therapy after stem cell transplantation is more effective than stem~     cell transplantation alone in treating relapsed or refractory non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in~     treating patients who have relapsed or refractory non-Hodgkin's lymphoma and have undergone~     autologous stem cell transplantation.~   "
267678|NCT00028938|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients~     who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy~     combined with radiation therapy is more effective with or without epoetin alfa in treating~     non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined~     with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA~     or stage IIIB non-small cell lung cancer.~   "
267679|NCT00063479|"~     The primary purpose of this trial is to evaluate whether the investigational medication is~     safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta~     (OI) patients.~   "
267680|NCT00063453|"~     To test whether supplementation with selenium and/or vitamin E affects pulmonary function.~   "
267681|NCT00063440|"~     To determine the factors associated with progression of sub-clinical atherosclerosis and to~     evaluate the associations between the progression of sub-clinical atherosclerosis and the~     development of clinically manifest atherosclerosis.~   "
267682|NCT00028925|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or~     without filgrastim in treating patients who have extensive-stage small cell lung cancer that~     has not been previously treated.~   "
267683|NCT00028613|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver~     tumor-killing substances such as radioactive iodine to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in~     treating patients who have large cell lymphoma that has been previously treated.~   "
267684|NCT00063427|"~     Assess the clinical activity of MAC-321 administered IV as a second-line or third-line~     antineoplastic agent to subjects with advanced colorectal cancer. Clinical activity will be~     assessed by determining the percentage of subjects exhibiting an objective response (complete~     plus partial responses). Tumor response will be assessed following modified Response~     Evaluation Criteria in Solid Tumors (RECIST) guidelines.~   "
267685|NCT00063414|"~     This is a multi-center trial to test the safety, efficacy and tolerability of alicaforsen~     (ISIS 2302), a new type of drug called an antisense drug, in patients with mild to moderate~     active Ulcerative Colitis (UC). Alicaforsen is designed to reduce the production of a~     specific protein, called ICAM-1, a substance that plays a significant role in the increase of~     inflammation and is likely to be involved in inflammatory bowel diseases such as ulcerative~     colitis. The ISIS 2302-CS22 study will examine the effects of one of two dosages of~     alicaforsen delivered by enema over a six-week period as compared to an active control,~     mesalamine enema (The probability of receiving the alicaforsen formulation is 2:1). The~     primary objective of this study is to evaluate the percentage reduction in DAI at Week 6.~   "
267686|NCT00063401|"~     The purpose of this study is to determine the progression-free survival obtained with~     cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage~     ovarian, primary peritoneal, or fallopian tube cancer.~   "
267687|NCT00063388|"~     Determine tumor response rate and time to disease progression, survival and safety in total~     populations.~   "
267688|NCT00063375|"~     This study will develop an interactive computer-based version of cognitive behavioral therapy~     (CBT) and compare its effectiveness to book-based CBT for the treatment of panic disorder.~   "
267689|NCT00063362|"~     This study will compare triple and double drug regimens in the treatment of patients with~     depression, hypomania, or mania.~   "
267690|NCT00063336|"~     This study will examine the ways in which schizophrenia-related symptoms affect response to a~     rehabilitation program for people with schizophrenia.~   "
267691|NCT00030446|"~     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor~     cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin~     may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in~     treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.~   "
267692|NCT00028483|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies can locate tumor cells and deliver~     tumor-killing substances to them without harming normal cells. Combining chemotherapy with~     monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and monoclonal~     antibody therapy in treating women who have metastatic or recurrent breast cancer.~   "
267693|NCT00006968|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with donor peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of pentostatin followed by peripheral~     stem cell transplantation in treating patients who have advanced kidney cancer.~   "
267694|NCT00003352|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     doxorubicin, cyclophosphamide, and docetaxel in treating women with stage IIIB or stage IV~     breast cancer.~   "
267695|NCT00063310|"~     ALADDIN is a research study to investigate the safety and effectiveness of leuprolide (a~     hormone drug) to improve the cognitive function and slow the progression of Alzheimer's~     disease (AD). In women leuprolide is commonly used to treat hormone related conditions such~     as endometriosis and uterine fibroids. The study will include treatment of women 65 years and~     older with mild to moderate Alzheimer's disease who reside in the community.~   "
267696|NCT00063297|"~     This study is to determine the efficacy (how well the drug works), safety, and side effects~     of the study medication compared to placebo in the treatment of the negative symptoms of~     schizophrenia in adults.~   "
267697|NCT00040729|"~     RATIONALE: Genetic testing for a specific enzyme may help doctors determine whether side~     effects from or response to chemotherapy are related to a person's genetic makeup.~      PURPOSE: Genetic trial to determine whether different forms of the UGT1A1 gene are related to~     the body's ability to break down drugs and to the gastrointestinal side effects seen in~     patients previously treated with flavopiridol.~   "
267724|NCT00063024|"~     Osteoporosis is a condition defined by decreased bone mass. Osteoporosis generally affects~     older women and can lead to bone fractures. One way to prevent osteoporosis is to build~     strong, healthy bones during childhood. This study will evaluate a program designed to~     improve girls' bones. The program encourages eating foods rich in calcium and participating~     in physical activity.~   "
271209|NCT00036062|"~     The purpose of this study is to determine whether sivelestat will reduce the amount of time a~     patient must spend on a ventilator and/or increase the chance of survival of patients with~     acute lung injury.~   "
267698|NCT00063284|"~     Super rapid transcranial magnetic stimulation (srTMS) is a method of brain stimulation that~     may be able to change the electrical activity of the nerve cells of the brain. It has been~     proposed and tested as a treatment for brain disorders, including Parkinson's disease.~      The purpose of this study is to use a device called the magnetic stimulator to investigate~     the safe limit of srTMS, such as intensity of stimulation and the number of magnetic pulses~     that may lead to excessive brain stimulation.~      Ten patients with Parkinson's disease-whose main problems are slowness of movement and~     difficulty walking-will participate in this study. They will be asked to come to the~     laboratory for one experiment. Before and after srTMS treatment, investigators will test~     participants' brain function with a series of psychological tests and an EEG~     (electroencephalogram). The srTMS treatment is performed by placing an insulated coil of wire~     on the scalp and passing a very brief electrical current through the wire coil. The~     experiment will last 2 to 4 hours.~   "
267699|NCT00063258|"~     The goal of this clinical research study is to learn about the safety and effectiveness of~     OSI-774 when combined with standard chemotherapy (carboplatin and paclitaxel) before surgery~     in the treatment of non-small cell lung cancer.~   "
267700|NCT00063219|"~     This non-randomized, open-label clinical trial is designed to determine safety and clinical~     activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with~     non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage~     of patients with an objective tumor response after treatment with MAC-321. Patients must have~     been previously treated with a platinum-containing chemotherapy regimen.~      A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321~     intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will~     receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside~     of this research trial.~   "
267701|NCT00063206|"~     Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR~     versus subjects receiving placebo.~      Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global~     evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric~     Rating Scale for Depression, 17-item [HAM-D<sub>17</sub>] < 7) versus those subjects~     receiving placebo.~   "
267702|NCT00063193|"~     The goal of this study is to assess the impact of minocycline and creatine on the progression~     of Parkinson's disease, in order to determine whether it is reasonable to proceed with~     further study of either of these agents.~   "
267703|NCT00063154|"~     The purpose of this study is to determine if the study drug pertuzumab is effective in~     treating patients with advanced lung cancer that has recurred following prior chemotherapy.~   "
267704|NCT00063141|"~     The purpose of this study is to determine whether overall survival is prolonged in subjects~     with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated~     with cetuximab in combination with irinotecan compared with irinotecan alone as second-line~     therapy following treatment with a fluoropyrimidine and oxaliplatin based,~     non-irinotecan-containing regimen.~   "
267705|NCT00063128|"~     This is a research study of a study drug known as LY041001 or human insulin inhalation powder~     (HIIP). HIIP is a powder form of insulin made to be inhaled through the mouth and into the~     lungs using a special handheld device.~   "
267706|NCT00030797|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy in~     treating patients who have advanced or metastatic colorectal cancer.~   "
267707|NCT00026520|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth~     of the tumor. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.~     Combining interferon alfa with thalidomide may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with~     thalidomide in treating patients who have stage IV melanoma.~   "
267708|NCT00026364|"~     Phase I trial to study the effectiveness of ZD 1839 combined with irinotecan, leucovorin, and~     fluorouracil in treating patients who have locally advanced, locally recurrent, or metastatic~     colorectal cancer. Biological therapies such as ZD 1839 may interfere with the growth of~     tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining ZD 1839 with~     combination chemotherapy may kill more tumor cells.~   "
267709|NCT00026351|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells~     and either kill them or deliver cancer-killing substances to them without harming normal~     cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and rituximab in~     treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.~   "
267710|NCT00025571|"~     RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to~     light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells~     and, when exposed to light, become active and kill the tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in~     treating patients who have non-small cell lung cancer.~   "
267711|NCT00006013|"~     RATIONALE: SU5416 may stop the growth of multiple myeloma by stopping blood flow to the~     cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have~     refractory or relapsed multiple myeloma.~   "
267712|NCT00004037|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with~     recurrent or refractory ovarian or primary peritoneal cancer.~   "
267713|NCT00003054|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with~     recurrent or persistent cancer of the uterus.~   "
268146|NCT00058851|"~     The purpose of this study is to examine the short-term and long-term efficacy of massage~     therapy alone compared to massage therapy plus compression bandaging in the treatment of~     breast cancer treatment-related swelling of the arms and legs.~   "
267714|NCT00063245|"~     The purpose of this study is to determine whether a special coil designed for magnetic~     stimulation of areas deep in the brain can affect mood and emotion in healthy volunteers.~     Researchers hope to better understand how the brain controls mood and motivation and what~     goes wrong with this process in disease.~      For transcranial magnetic stimulation (TMS), a wire coil is held over the scalp. A brief~     electrical current passes through the coil and creates a magnetic pulse that stimulates the~     brain.~      Eighteen participants, 9 men and 9 women, will be enrolled in this study. They will be~     assigned to one or both of the following two experiments.~      Experiment 1~      In this experiment, researchers will test the effectiveness of a new type of wire coil. They~     will deliver magnetic impulses of varying strength. Approximately 150 stimulations will be~     given over of about 20 minutes. To determine whether the coil causes any problem with~     hearing, participants will undergo a hearing test immediately before and after the~     experiment.~      Experiment 2~      This experiment, which has two parts, is designed to determine whether TMS can affect mood.~     In the first part, participants will be asked to report any changes in mood before, during~     and after the magnetic stimulation. In the second part, they will be asked to choose between~     sets of 2 identical pictures-choosing one will result in full magnetic stimulation, choosing~     the other will result in stimulation at 10 percent of full intensity.~      Participants will be compensated up to $100 for their involvement in this study.~   "
267715|NCT00063232|"~     Nonalcoholic Steatohepatitis (NASH) is associated with progressive liver disease, fibrosis,~     and cirrhosis. Although the cause of NASH is unknown, it is often associated with obesity,~     type 2 diabetes, and insulin resistance. At present, there are no approved treatments for~     NASH patients, but an experimental approach has focused on improving their insulin~     sensitivity. Metformin is one of the most commonly used medications for the treatment of~     diabetes.~      The purpose of this study is to determine whether the medical problems of NASH patients,~     specifically liver damage, improves when their insulin sensitivity is enhanced with~     metformin.~      The study will last 3 to 5 years and will enroll up to 30 patients. Participants will undergo~     a complete medical examination, a series of lab tests, and a liver biopsy. They will then~     start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage~     twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to~     1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will~     undergo a repeat medical examination and liver biopsy.~   "
267716|NCT00063180|"~     Patients with stroke sometimes have a condition called diaschisis, a loss of function in a~     part of the brain located some distance from the original stroke-injury site. Doctors do not~     know why this happens.~      The purpose of this study is to get a better understanding as to why diaschisis occurs by~     studying people who have experienced a stroke and people who have aged in good health.~      Forty-four participants who are older than 40 year of age will be enrolled in this study-18~     healthy people and 26 stroke patients. They will have 3 to 4 study visits. The first visit~     will involve a medical history and a physical and neurological exam. Participants will then~     have a magnetic resonance imaging (MRI) scan, either on the first visit or on a later day. On~     the next visit, they will undergo a position emission tomography (PET) scan. Finally, they~     will return for another MRI scan.~   "
267717|NCT00063102|"~     The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how~     long the tumor shrinkage can be maintained in patients with breast cancer after having had~     taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be~     off drug for 7 days before starting the next cycle of drug.~   "
267718|NCT00063115|"~     Ideomotor apraxia, a disorder that affects patients with stroke and a variety of other brain~     lesions, features disturbed timing, sequence, and spatial organization of skilled movements.~     This study will look at how different areas of the human brain control fine hand movements.~      Thirty-five participants 21 years and older will be enrolled in this study-25 healthy,~     right-handed people, and 10 stroke patients. They will undergo two outpatient sessions, each~     lasting up to 3 hours. The first visit for the stroke patients will occur between 2 weeks and~     3 months after the stroke; the second visit will be at least 6 months after the stroke.~      Participants will have a physical exam, give a medical history, and complete a questionnaire.~     Then they will undergo magnetic resonance imaging (MRI) scans. They will lie in the MRI~     scanner and will be asked to do a number of skilled hand movements using the right hand (such~     as pretending to use a hammer or waving goodbye) in response to directions that will appear~     on a screen mounted over their head. Their movements will be recorded on videotape during the~     procedures.~   "
267719|NCT00063089|"~     Altastaph has been developed to help the removal of S. aureus from the bloodstream. The main~     objective of this study will be to test the safety and behavior of Altastaph in patients with~     S.aureus bacteremia and continuing fever~   "
267720|NCT00063076|"~     The goal of this clinical research study is to find the most effective dose of Targretin®~     (bexarotene) Gel 1% that can be given to patients as a treatment for alopecia areata. The~     safety and tolerability of this drug will also be studied.~      Objectives:~        1. Determine the safety and tolerability of Targretin® Gel 1% in the treatment of patients~          with alopecia areata.~        2. Determine the efficacy of Targretin® Gel 1% in the treatment of patients with alopecia~          areata.~   "
267721|NCT00063063|"~     The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD~     Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both~     mothers and infants, and the therapies used and outcomes of the infants. The information~     collected is not specific to a disease or treatment (i.e., it is generic). Data are~     analyzed to find associations and trends between baseline information, treatments, and infant~     outcome, and to develop future NRN trials.~   "
267722|NCT00063050|"~     The purpose of this study is to determine whether educating parents about health and behavior~     management techniques will increase physical activity, calcium intake, fitness, and bone~     density in their children.~   "
267723|NCT00063037|"~     Calcium is important for healthy bone growth in children. Poor bone growth and development~     during childhood can lead to osteoporosis later in life. This study will evaluate a nutrition~     education program designed to increase the amount of calcium children receive. The study will~     determine whether the program will result in long-term dietary changes and healthier bones in~     children.~   "
267725|NCT00063011|"~     Osteoporosis is a major public health problem. Prevention of osteoporosis depends in part on~     good bone development in childhood and adolescence. This study will evaluate a weight-bearing~     exercise program and high-calcium diet on bone development in adolescent girls.~   "
267726|NCT00025545|"~     RATIONALE: Transplanted peripheral stem cells can sometimes be rejected by the body's~     tissues. Treating donor peripheral stem cells with filgrastim may increase the number of~     donor white blood cells. This may help to decrease the rejection of the transplanted cells in~     patients receiving them as treatment for acute leukemia.~      PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral~     stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell~     transplantation.~   "
267727|NCT00024323|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining 3-AP with cisplatin in~     treating patients who have advanced cancer.~   "
267728|NCT00024310|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Folic acid may protect normal cells from the side effects of~     chemotherapy and may increase the effectiveness of chemotherapy by making tumor cells more~     sensitive to the drug. Lometrexol may stop the growth of tumors by blocking one of the~     enzymes necessary for cancer cell growth. Combining chemotherapy with folic acid and~     lometrexol may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel, folic acid, and~     lometrexol in treating patients who have locally advanced or metastatic solid tumors.~   "
267729|NCT00024141|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in~     treating patients who have advanced solid tumors.~   "
267730|NCT00023933|"~     Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in~     treating patients who have recurrent or persistent metastatic colorectal cancer. Radiolabeled~     monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them~     without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective~     treatment for colorectal cancer~   "
267731|NCT00062998|"~     We have recently validated a new device for measurement of physical activity and found it to~     detect type, duration and intensity of many types of physical activity at better than 98%~     accuracy. After further validating this device to determine if it can also accurately assess~     energy expenditure, we will use it to collect cross-sectional data on free-living physical~     activity and energy expenditure in adolescent girls.~   "
267732|NCT00062985|"~     The aim of the present study is to evaluate the effectiveness of two different delivery~     formats for weight management in a managed care setting. Mail-based weight counseling and~     phone-based weight counseling will be compared to each other and a control condition. Primary~     outcomes are participation rates in programs, weight change, and cost.~   "
267733|NCT00062972|"~     People with multiple sclerosis (MS) suffer from cognitive and other brain problems. This~     study will examine the effectiveness of the drug donepezil and of sugar water for enhancing~     memory in individuals with MS. Donepezil (also known as Aricept) has been FDA approved for~     improving memory and learning in individuals with Alzheimer's disease.~   "
267734|NCT00062959|"~     Problem behaviors such as drug use, violence, and school misconduct increase during~     adolescence. This study evaluated a program designed to prevent problem behaviors in middle~     school students; the program includes classroom instruction for students and home instruction~     for parents.~   "
267735|NCT00062907|"~     The purpose of this trial is to examine the safety and immunogenicity of a therapeutic~     vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with~     early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses~     of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S).~     The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.~   "
267736|NCT00062894|"~     The purpose of this study is to assess the blood pharmacokinetics in patients with previously~     untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have~     received a dosimetric dose of fission-derived iodine I 131 tositumomab.~   "
267737|NCT00062946|"~     The purpose of this study is to measure molecules on or in cells that interact with a~     chemical in the nervous system, called dopamine. Investigators will obtain two kinds of~     images of the brain-a position emission tomography (PET) scan and a magnetic resonance~     imaging (MRI) scan.~      Thirty-eight participants aged 18 to 45 will be enrolled in this study. They must have no~     history of medical or psychiatric illness, including substance abuse. Participants will have~     four appointments at NIH. On the first visit, they will undergo a physical exam, a medical~     history, and lab tests. The second and third visits will involve PET scans and the fourth~     visit will involve an MRI scan.~      Participants will be compensated up to $430 for their involvement in this study.~   "
267738|NCT00062933|"~     Ocular melanoma, or cancer of the eye, is a rare form of cancer that can spread to the liver.~     A tumor in the liver, because of its size or location, sometimes cannot be removed with~     surgery.~      The purpose of this study is to determine whether chemotherapy delivered only to the liver,~     called isolated hepatic perfusion (IHP), followed by systemic (to the whole body)~     chemotherapy improves the ability to treat cancer.~      Study participants must be 18 years or older and have ocular melanoma that has spread to the~     liver. Before enrolling in the study, they will undergo the following evaluations: a physical~     exam; x-rays; blood tests; electrocardiogram; computed tomography (CT) scan of the chest,~     abdomen and pelvis; and a magnetic resonance imaging (MRI) scan of the liver.~      The study includes a 15-minute quality-of-life questionnaire. Participants will complete the~     questionnaire 7 times over a period of 2 years to help investigators gauge their health~     status and progress.~      A laparotomy is done, which allows a surgeon to view the tumor in the liver through a small~     incision in the abdomen while the patient is under general anesthesia. Sometimes the tumor~     can spread outside the liver in a way that cannot be seen by pre-operative scans. When this~     happens, the participant is ineligible to continue in the study, since an important part of~     the treatment is given only to the liver.~      If the laparotomy reveals that the participant is eligible for the remainder of the study,~     the participant will receive IHP treatment during the surgery. Plastic tubes called catheters~     are placed in the vein and artery that feed and drain the liver. This creates a separate~     blood supply for the liver alone. Heated chemotherapy is then given into the liver blood~     supply for one hour, while being carefully kept out of the rest of the body.~      After recovering from the surgery, eligible participants will receive a systemic chemotherapy~     called temozolomide for up to one year. This chemotherapy is taken by mouth in capsule form.~      Participants will be asked to return to NIH 10-11 times during the first year to evaluate~     their progress.~   "
267739|NCT00062881|"~     This research study is an investigational treatment with the experimental drug Mafosfamide.~     This treatment is only for children with cancer that has spread to the meninges (tissues that~     cover the spinal column and brain) and has continued to grow despite treatment with standard~     therapy.~      Mafosfamide is a drug reported to have antitumor effects in animals and that has been given~     safely into the cerebrospinal fluid (the fluid within and surrounding the brain) in a small~     number of children and adults. Since there is limited experience in adults and children in~     giving mafosfamide in this way, the main purpose of this study is to determine the~     appropriate safe dose of mafosfamide when given intrathecally, that is directly into the~     cerebrospinal fluid.~      The purposes for this study are to (a) determine what dose of mafosfamide can be safely given~     into the cerebrospinal fluid through an Ommaya reservoir (surgically implanted catheters used~     to sample cerebrospinal fluid and to instill medication into the cerebrospinal fluid) and~     lumbar puncture (spinal tap) or lumbar reservoir; (b) look for side effects of drug~     treatment; (c) to study the pharmacology (how the human body handles the drug) when given~     directly into the spinal fluid; and (d) see if this drug is beneficial to the patient.~   "
267740|NCT00062868|"~     Patients have a type of lymph gland disease (HD or NHL, Lymphoepithelioma, severe chronic~     active EBV (SCAEBV), or leiomyosarcoma) which has come back or may come back or has not gone~     away after treatment, including the best treatment known for these diseases. This research~     study uses special immune system cells called LMP- specific cytotoxic T lymphocytes, a new~     experimental therapy.~      Some patients with Lymphoma or SCAEBV or leiomyosarcoma show evidence of infection with the~     virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of~     their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's~     and NHL, suggesting that it may play a role in causing Lymphoma. The cancer cells (in~     lymphoma) and some B cells (in SCAEBV) infected by EBV are able to hide from the body's~     immune system and escape destruction. Investigators want to see if special white blood cells,~     called T cells, that have been trained to kill EBV infected cells can survive in the blood~     and affect the tumor.~      The Investigators have used this sort of therapy to treat a different type of cancer that~     occurs after bone marrow or solid organ transplant called post transplant lymphoma. In this~     type of cancer the tumor cells have 9 proteins made by EBV on their surface. The~     investigators grew T cells in the lab that recognized all 9 proteins and were able to~     successfully prevent and treat post transplant lymphoma. However, in HD and NHL and SCAEBV,~     the tumor cells and B cells only express 2 EBV proteins. In a previous study, T cells were~     made that recognized all 9 proteins and were given to patients with HD. Some patients had a~     partial response to this therapy but no patients had a complete response. The investigators~     think one reason may be that many of the T cells reacted with proteins that were not on the~     tumor cells. In this study, they are trying to find out if they can improve this treatment by~     growing T cells that recognize proteins expressed on EBV infected Lymphoma cells and B cells~     called LMP-1 and LMP2. These special T cells are called LMP-specific cytotoxic T-lymphocytes~     (CTLs). These LMP-specific cytotoxic T cells are an investigational product not approved by~     the FDA.~      The purpose of this study is to find the largest safe dose of LMP-specific cytotoxic T cells,~     to learn what the side effects are and to see whether this therapy might help patients with~     HD, NHL, Lymphoepithelioma, SCAEBV or leiomyosarcoma.~   "
267741|NCT00062855|"~     This research study is designed to determine the safety and dosage of special cells that may~     make a patients own immune system fight the cancer. To do this we will put two special genes~     into cancer cells taken from the patients body. The genes we put in make the cancer cells~     produce lymphotactin, a natural substance that attracts immune system cells to the cancer,~     and IL-2 a natural substance that may help the immune system kill cancer cells. Some of these~     cells will then be put back in the patient's body. Studies of cancers in animals and in~     cancer cells that are grown in laboratories suggest that substances like lymphotactin and~     IL-2 help the body kill cancer cells. A treatment similar to this has been used in ten~     children previously and similar treatments are being used in adults with other cancers.~      The purpose of this study is to learn the side effects and safe 'dosage' of these special~     cells.~   "
267742|NCT00062842|"~     The medicine being offered in this study is called Irinotecan. Irinotecan has been effective~     against many animal cancers. It has been given to both adults and children. We are now~     attempting to determine how much of the drug can be given to children when Irinotecan is~     given weekly for four weeks in a row every 6 weeks and the toxicities (bad side effects) that~     occur when irinotecan is administered on this schedule.~      The purposes of this study are to:~        1. To determine the highest dose of Irinotecan that can safely be given to children whose~          cancer no longer responds to standard treatment.~        2. To determine the toxicities of Irinotecan.~        3. To determine what studies (laboratory or x-rays) need to be done to evaluate the~          toxicities of this drug.~        4. To determine if irinotecan is beneficial to the patient.~        5. To understand how the drug Irinotecan works in the body.~   "
267743|NCT00062829|"~     The purpose of this study is to evaluate the effectiveness of a program designed to reduce~     teen crashes and risky driving by increasing parental monitoring and restriction of their~     adolescents' driving practices during the first year of licensed driving.~   "
267744|NCT00062816|"~     The purposes of this Phase 1/2 study are to examine the safety, tolerability, and antiviral~     activity of ISIS 14803, when given in combination with peginterferon alfa and ribavirin, to~     patients who either failed to have at least a 100-fold HCV reduction at Week 12 of standard~     therapy or still have detectable HCV at Week 24.~   "
267745|NCT00002643|"~     Phase II trial to study the effectiveness of combination chemotherapy in treating patients~     with newly diagnosed metastatic Ewing's sarcoma or primitive neuroectodermal tumor. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug may kill more tumor cells.~   "
267746|NCT00062803|"~     Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this~     study. The purpose of the study is to compare the safety and effectiveness of a new~     injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a~     pulmonary embolism. The standard treatment includes injections or infusions of an~     anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets~     (warfarin or acenocoumarol) which are taken by mouth.~      Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by~     chance and will be known by both patients and their doctors.~   "
267747|NCT00062790|"~     This study is being done to determine how much certain hormone levels in the prostate~     decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male~     patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill)~     once daily by mouth for 3 months prior to having a surgery to reduce the size of their~     prostate. During the surgery, very small pieces of the prostate that are removed will be~     tested to see how much dihydrotestosterone and testosterone (male hormones) are in the~     tissue.~   "
267761|NCT00062660|"~     To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir~     combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have~     failed or are intolerant to currently approved treatments for HIV infection, who are unable~     to participate in another tipranavir controlled clinical trial and have an urgent need for~     anti-HIV treatment.~   "
267748|NCT00027612|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Irinotecan may make the tumor cells more sensitive to radiation therapy.~      PURPOSE: This phase I/II trial is studying the side effects of irinotecan given together with~     radiation therapy followed by irinotecan and carmustine and to see how well it works in~     treating patients with newly-diagnosed glioblastoma multiforme.~   "
267749|NCT00025376|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which regimen of PS-341 is more effective in~     treating metastatic kidney cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients~     who have metastatic kidney cancer.~   "
267750|NCT00023868|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood~     flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known if~     chemoembolization is more effective than standard chemotherapy in treating metastatic cancer.~      PURPOSE: This phase I trial and randomized phase III trial is studying the effectiveness of~     chemoembolization in treating patients who have colorectal cancer metastatic to the liver.~   "
267751|NCT00022594|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal lurtotecan in treating~     patients who have metastatic or locally recurrent head and neck cancer.~   "
267752|NCT00022529|"~     Phase I trial to study the effectiveness of BMS-214662 plus trastuzumab in treating patients~     who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab~     can locate tumor cells and either kill them or deliver tumor-killing substances to them~     without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may~     kill more tumor cells~   "
267753|NCT00062777|"~     Since 1948, residents of Framingham, Massachusetts, have participated in a program that~     collects blood samples and clinical data to provide a rare and valuable database for~     scientific research.~      The purpose of this study is to support this national resource by aiding in its research~     capacity. Specifically, researchers in this study will (1) investigate heart, lung, and blood~     diseases; stroke; memory loss; joint disease; bone loss; deafness; cancer; blood vessel~     diseases and other health conditions, and (2) examine DNA and its relationship to risk of~     developing these disease and health conditions.~      Approximately 330 families have participated in the Framingham Study. Participants will be~     required to undergo a four-hour exam and to take that exam every two years thereafter. During~     the exam, the Framingham investigators will (1) interview participants about medical status,~     health issues, and lifestyles; (2) perform a regular physical exam; (3) obtain blood and~     urine samples and administer a glucose-tolerance test; (4) supervise a brisk six-minute~     treadmill walk; (5) administer an ultrasound procedure; and (6) review and obtain copies of~     medical and hospital records. Participants will also be asked to complete a questionnaire at~     home regarding dietary and health habits.~   "
267754|NCT00062764|"~     Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic~     hepatitis but occurs in persons who drink little or no alcohol. The etiology of NASH is~     unclear, but it is commonly associated with diabetes, obesity, and insulin resistance.~     Several pilot studies, including a study of pioglitazone at the NIH Clinical Center~     (01-DK-0130), have shown that the insulin-sensitizing thiazolidinediones lead to decreases in~     serum alanine aminotransferase (ALT) levels and improved liver histology. Once therapy is~     stopped, however, ALT levels rapidly return to pre-treatment values. Inaddition we are~     currently enrolling patients with NASH in a pilot study of metformin therapy for 48-weeks,~     however our results in 3 patients thus far have not been very encouraging.~      In the current study, patients who have completed the pilot study of pioglitazone and have~     been off therapy for 48 weeks will be offered re-treatment for 3 years. We also propose to~     treat patients who have not had a satisfactory response to metformin with pioglitazone for~     the same duration. After a repeat medical and metabolic evaluation and liver biopsy, patients~     with moderate-to-severe NASH (activity score greater than or equal to 4) will restart~     pioglitazone at a dose of 15 mg daily. If after 48 weeks, ALT levels are not normal or~     improved to the degree identified during the pilot study, the dose will be increased to 30 mg~     daily at the end of 3 years, all patients will undergo repeat medical and metabolic~     evaluation and liver biopsy. The primary end point will be improvement in liver histology.~     Secondary end points will be improvements in insulin sensitivity, reduction in visceral fat,~     liver volume, and liver biochemistry. The aim of this study is to evaluate whether long-term~     pioglitazone therapy can safely achieve and maintain biochemical and histological~     improvements in NASH.~   "
267755|NCT00062751|"~     To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules~     of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole,~     compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer~     in postmenopausal women. All patients must be appropriate to receive endocrine therapy as~     treatment for advanced disease.~   "
267756|NCT00062738|"~     The goal of this study is to evaluate the effectiveness and safety of two~     antidepressants--nortriptyline and paroxetine, compared to placebo in patients with~     Parkinson's disease and depression.~   "
267757|NCT00062699|"~     To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for~     the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney~     disease on hemodialysis as measured by time to death.~   "
267758|NCT00062712|"~     Patients with renal failure need chronic dialysis or a kidney transplant to survive. Most~     kidney transplant patients must take medicines indefinitely to prevent their immune systems~     from rejecting the kidney. Long-term exposure to these anti-rejection medicines can damage~     the transplanted kidney.~      The purpose of this study is to determine whether giving patients cells from the donor's bone~     marrow will reduce or eliminate the need for long-term use of these anti-rejection drugs. In~     addition to the donor's bone marrow cells, patients will receive the drugs thymoglobulin and~     sirolimus.~      A total of 20 patients will participate in this five-year study.~   "
267759|NCT00062686|"~     This study was designed to determine the efficacy of an oral dual kinase inhibitor for the~     treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a~     refractory patient population.~   "
267760|NCT00062673|"~     A study of the safety and efficacy of duloxetine in elderly patients (greater than 65 years~     old) with major depressive disorder~   "
267762|NCT00062647|"~     The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety~     administered to patients with bloodstream infections and whether telavancin is effective in~     treating these infections.~   "
267764|NCT00062621|"~     The purpose of this study is to determine whether a combined bone marrow and kidney~     transplant will be effective in treating stage II or greater multiple myeloma and associated~     kidney failure. This study will determine whether transplant rejection and the need for~     immunosuppressive drugs are decreased with this combined transplant approach.~   "
267765|NCT00062608|"~     The aims are to evaluate: (1) the effectiveness of written self-disclosure (WSD) on health~     status of youth ages 12-18 with functional recurrent abdominal pain (RAP); (2) whether~     effectiveness of WSD is similar for younger (12-14) and older (15-18) youth with functional~     RAP; and (3) the feasibility and acceptability of WSD when extended to the pediatric health~     care setting.We will implement a randomized, controlled trial (RCT) designed to compare~     health status in 140 youths (ages 12-18) with functional RAP assigned either to standard~     medical care (SMC) or WSD provided in the health care setting in addition to SMC. Health~     status will be measured at Baseline and 3- and 6-months thereafter. Primary measures of~     health status are symptom severity and episode frequency, consistent with the definition of~     RAP. Secondary measures of health are functional health, psychological distress,~     health-related quality of life, and health care utilization. Total use and diagnostic tests~     will index health care utilization, collected for the 6-mos prior to and following Baseline.~     Mixed model ANOVA or MANOVA will be used to test directional hypotheses corresponding to the~     specific aims.~   "
267766|NCT00062595|"~     This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study~     supplementation effects on bone turnover and bone density. Women at least 5 years~     postmenopause with normal bone density who do not use estrogen therapy or the following~     medications may be eligible:~      alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel),~     zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin~     (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will~     take calcium and vitamin D (Citracal) twice a day for the first two months and through-out~     the study. After the first two months, subjects are randomized to the K1, MK4 or placebo~     groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at~     each visit and bone density is performed at 3 study visits.~   "
267767|NCT00062569|"~     This study will evaluate the effectiveness of a 3-week reminiscence intervention applied~     during bathing persons with Alzheimer's disease (AD) in decreasing resistiveness to care~     (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden,~     capabilities and confidence while bathing the patient. Reminiscence provides opportunities~     for the patient to feel good and recall pleasant memories, easily done by caregivers in a~     home setting. Home visits and telephone calls from trained nurses provide coaching and~     practice for caregivers for the preliminary phase of this study. Each couple will be enrolled~     in the study for approximately 9 weeks. The study will recruit 100 patient/spouse caregiver~     couples randomly divided into one of two groups: reminiscence with coaching, or bathing~     support (control). Bathing support will be provided to participants in both conditions~     including: individualized assessment; education regarding bathing techniques for people with~     dementia; and individualized problem solving. In addition to the bathing support~     intervention, participants in the experimental group will receive a pleasant memories~     interview and reminiscence script with coaching for implementation. Caregivers will keep a~     journal of their experiences in bathing the care recipient.~   "
267768|NCT00062556|"~     The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses,~     compared to diet control (this group will receive a tablet containing 50 mg. of~     immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused~     by a narrowing of their leg arteries, a condition called intermittent claudication.~      At least 366 subjects with leg pain caused by a narrowing of their leg arteries will~     participate in this study.~      Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration)~     approved cholesterol modifying medications: Niaspan® (extended-release niacin) and~     lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved~     by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The~     use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic~     relief of intermittent claudication is considered investigational. An investigational use is~     one that is not approved by the FDA.~   "
267769|NCT00062543|"~     The primary objective is to determine whether donor stem cells administered via hepatic~     artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem~     cell transplantation (SCT) and the safety of this procedure. The secondary objective is to~     improve liver function and improve survival.~   "
267770|NCT00062530|"~     This study will test the safety of and immune response to an oral HIV vaccine in healthy~     volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to~     deliver an HIV gene into the body through the mouth. The body then produces an HIV protein~     from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only~     one of the many substances that HIV needs to make more copies of itself, so the vaccine~     itself cannot cause HIV or AIDS.~   "
267771|NCT00062504|"~     To analyze the effect of Talampanel on progression free survival in patients with recurrent~     high grade gliomas.~   "
267772|NCT00062491|"~     The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as~     a treatment for Malignant Melanoma.~   "
267773|NCT00062478|"~     The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a~     treatment of adults with brain tumors.~   "
267774|NCT00022009|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Treatment plus supportive care may improve quality of life in~     patients undergoing cancer treatment.~      PURPOSE: Randomized phase II/III trial to compare the effect of different gemcitabine~     regimens plus supportive care on quality of life in patients who have locally advanced or~     metastatic non-small cell lung cancer.~   "
267775|NCT00018954|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of two treatment regimens for patients in~     developing countries with diffuse non-Hodgkin's lymphoma and acute lymphoblastic leukemia.~   "
267776|NCT00017446|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have~     locally advanced or metastatic soft tissue sarcoma.~   "
267777|NCT00017394|"~     Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in~     treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab~     can locate tumor cells and either kill them or deliver tumor-killing substances to them~     without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Combining monoclonal antibody with~     chemotherapy may kill more cancer cells~   "
267778|NCT00017316|"~     Phase II trial to study the effectiveness of combining thalidomide and SU5416 in treating~     patients who have metastatic melanoma. Thalidomide combined with SU5416 may stop the growth~     of metastatic melanoma by stopping blood flow to the tumor.~   "
267779|NCT00062582|"~     The aim of the study is to compare the effect of roflumilast and placebo on the lung function~     in patients with COPD.~   "
267780|NCT00016107|"~     Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal~     antibody therapy in treating patients who have metastatic prostate cancer that has not~     responded to previous hormone therapy. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as~     bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor.~     Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.~   "
267781|NCT00014664|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal~     antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's~     lymphoma.~   "
267782|NCT00014534|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in~     treating patients who have advanced bladder cancer.~   "
267783|NCT00014170|"~     Biological therapies such as gefitinib may interfere with the growth of the tumor cells and~     slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of~     gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.~   "
267784|NCT00062517|"~     The purpose of this study is to increase researchers understanding of the biological basis of~     generalized anxiety disorder and social anxiety disorder. They will investigate how the brain~     activity associated with specific thoughts and feelings may play a role in these anxiety~     disorders. This knowledge will be used to design interventions to help those with these~     illnesses.~      To qualify for this study, participants must be evaluated via an initial telephone screening~     interview and material sent through the mail.~      Participants will then be required to make three visits to NIH. During the first visit, they~     will be asked questions about their general mood, degree of nervousness, thinking skills, and~     behavior. They will undergo a thorough physical exam, including an EKG, blood work,~     urinalysis, and a pregnancy test for women of childbearing potential. During the second~     visit, participants will spend about 2.5 hours doing various tasks while sitting and looking~     at a computer screen. These tasks will guide them to experience specific kinds of thoughts~     and emotions. Researchers will attach electrodes to the participants hands to monitor the~     amount of electricity conducted by the skin. The third visit will be similar to the second~     visit, but participants will perform the tasks while lying in a MRI scanner.~      Participants will be compensated up to $400 for their involvement in this study.~   "
267785|NCT00012155|"~     RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the safety of NV1020 in patients who have colon cancer that~     has spread to the liver and has not responded to previous chemotherapy.~   "
267786|NCT00062465|"~     Various forms of the plant extract Tripterygium wilfordi Hook F (TwHF) have been used in~     China as a remedy for inflammatory diseases, including rheumatoid arthritis. The purpose of~     this study is to investigate how tolerable, safe, and effective TwHF is for patients with~     rheumatoid arthritis. Investigators will compare the therapeutic effects of TwHF with~     Sulfasalazine, an FDA-approved drug for arthritis.~      Participants in this 24-week study must have had active rheumatoid arthritis for at least six~     months. Approximately 120 patients will participate. Participants will be assigned to one of~     two drug-treatment groups, TwHF or Sulfasalazine. They will be given the study drug at each~     of six clinic visits and will be asked to take two capsules three times each day with meals~     and water. During the clinic visits, investigators will obtain multiple blood samples; give~     physical exams; assess swollen, tender, and painful joints; and administer x-rays.~      Study participants will be compensated up to $260 for their involvement in this study.~   "
267787|NCT00062452|"~     Feeding difficulties and airway related consequences contribute significantly to the infant~     mortality and morbidity. Some of these problems may be dependent on neural control and~     muscular function. Prematurity, congenital anomalies and perinatal depression represent three~     important conditions in infants, that may have feeding and airway difficulties.Development of~     motility of the foregut and the adaptation during normal and disease in developing infants is~     unclear.~   "
267788|NCT00062439|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with~     radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel~     after surgery may kill any remaining tumor cells.~      PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with~     cisplatin and etoposide followed by surgery and docetaxel works in treating patients with~     newly diagnosed Pancoast tumors, a type of non-small cell lung cancer.~   "
267803|NCT00062205|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes~     necessary for tumor cell growth.~      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating~     patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.~   "
267789|NCT00062426|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and~     capecitabine, work in different ways to stop tumor cells from dividing so they stop growing~     or die. Combining more than one drug and giving them in different combinations may kill more~     tumor cells. Monoclonal antibodies, such as bevacizumab (Avastin™), can block cancer growth~     in different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet~     known which regimen works better in treating advanced colorectal cancer.~      PURPOSE: This randomized phase III trial is to see if oxaliplatin and bevacizumab work better~     when combined with either fluorouracil and leucovorin or capecitabine in treating patients~     who have metastatic or recurrent colorectal cancer.~   "
267790|NCT00062400|"~     RATIONALE: Adjuvant therapy given after surgery for early breast cancer may cause~     infertility. Assessing young women's attitudes and feelings about the risk of infertility may~     help improve the ability to plan effective treatment.~      PURPOSE: This clinical trial is studying young women's attitudes and feelings about the risk~     of infertility related to adjuvant therapy for stage I or stage II breast cancer.~   "
267791|NCT00062387|"~     Phase II trial to study the effectiveness of perifosine in treating patients who have~     recurrent or metastatic head and neck cancer. Drugs used in chemotherapy such as perifosine~     use different ways to stop tumor cells from dividing so they stop growing or die.~   "
267792|NCT00062374|"~     This phase II trial is studying how well giving irinotecan together with cisplatin works in~     treating patients who are undergoing surgical resection for locally advanced cancer of the~     stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and~     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one chemotherapy drug and giving them before surgery may shrink the~     tumor so that it can be removed during surgery.~   "
267793|NCT00062348|"~     RATIONALE: Diagnostic procedures using boronophenylalanine-fructose complex (BPA-F) and/or~     sodium borocaptate (BSH) to detect the presence of boron in tumor cells may help determine~     whether patients who have thyroid cancer, head and neck cancer, or liver metastases may~     benefit from boron neutron capture therapy.~      PURPOSE: This phase I trial is studying the side effects of giving BPA-F and/or BSH before~     surgery to detect boron uptake in tissues of patients with primary, metastatic, or recurrent~     thyroid cancer, head and neck cancer, or liver metastases from colorectal cancer.~   "
267794|NCT00062335|"~     RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan~     treatment may enable doctors to provide more effective radiation therapy that will cause less~     damage to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of high-dose~     3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage~     II, or stage IIIA non-small cell lung cancer.~   "
267795|NCT00062322|"~     RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to~     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Irinotecan and cisplatin may also make the tumor~     cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy~     before surgery may shrink the tumor so that it can be removed during surgery.~      PURPOSE: This phase I trial is studying the side effects of neoadjuvant radiation therapy~     given together with irinotecan and cisplatin followed by surgery in treating patients with~     limited-stage small cell lung cancer.~   "
267796|NCT00062309|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill~     tumor cells. It is not yet known which radiation therapy regimen is more effective in~     treating prostate cancer.~      PURPOSE: This randomized phase III trial is comparing two different regimens of radiation~     therapy to see how well they work in treating patients with stage II or stage III prostate~     cancer.~   "
267797|NCT00062296|"~     RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop cancer~     cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can~     locate cancer cells and either kill them or deliver cancer-killing substances to them without~     harming normal cells. Combining epirubicin with rituximab may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in~     treating patients who have relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic~     lymphocytic leukemia.~   "
267798|NCT00062283|"~     RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well alanosine works in treating patients with~     soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or~     pancreatic cancer.~   "
267799|NCT00062270|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Biological therapies such as gefitinib may interfere with the growth of the tumor cells and~     slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib~     before surgery may shrink the tumor so that it can be removed during surgery.~      PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with~     or without gefitinib in treating patients who are undergoing surgery for stage III non-small~     cell lung cancer.~   "
267800|NCT00062257|"~     RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well irofulven works in treating patients with~     recurrent or metastatic gastric cancer.~   "
267801|NCT00062244|"~     This phase I/II trial is studying the side effects and best dose of oblimersen and to see how~     well it works in treating patients with relapsed or refractory Waldenstrom's~     macroglobulinemia. Biological therapies such as oblimersen may interfere with the growth of~     the cancer cells and slow or stop the growth of Waldenstrom's macroglobulinemia.~   "
267802|NCT00062231|"~     RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective~     in preventing or controlling fever and neutropenia in patients with cancer. It is not yet~     known whether moxifloxacin alone is more effective than amoxicillin combined with~     ciprofloxacin in treating neutropenia and fever.~      PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares~     it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients~     with cancer.~   "
267804|NCT00062179|"~     RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways~     to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the~     effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may~     stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the~     enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib~     before surgery may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying how well giving paclitaxel together with~     carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin~     and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung~     cancer.~   "
267805|NCT00062166|"~     Von Hippel-Lindau disease (VHL) is an inherited cancer syndrome. Patients are at risk for~     developing pancreatic cysts and tumors. These tumors are more aggressive in some people than~     in others. To learn more about this disease, its genetic cause and how best to treat it, this~     study will 1) identify patients with VHL who have pancreatic lesions; 2) examine the~     characteristics of the lesions and how fast they grow; 3) study how well imaging tests can~     reveal lesion characteristics that will help in diagnosis; and 4) perform genetic studies~     using blood and, when possible, tissue samples.~      Patients 12 years of age and older with VHL involving the pancreas may be eligible for this~     study. Participants will undergo some or all of the following tests and procedures:~        -  Interviews with a cancer doctor, cancer nurses, and a surgeon (if surgery is~          recommended).~        -  Computed tomography (CT) scan of the abdomen, chest, or pelvis. This test uses x-rays to~          produce images of body tissues and organs in small sections.~        -  Magnetic resonance imaging (MRI) of the abdomen. This test uses radio waves and a strong~          magnetic field to produce images of body tissues and organs.~        -  Ultrasound of the abdomen. This test uses sound waves to create images body tissues and~          organs.~        -  Blood tests for routine laboratory chemistries, for tests specific to the pancreas, and~          for genetic studies~        -  24-hour urine studies~      After the tests are completed, the doctor will discuss the results with the patient. Patients~     with a pancreatic tumor that requires surgery will be offered the option of an operation to~     remove as much tumor as possible. Patients with lesions that are not appropriate for surgery~     will be asked to return to NIH for scans and x-rays every year to monitor growth of the~     lesions. If surgery should become advisable in the future, the option will be discussed at~     that time. Patients with pancreatic cysts will be asked to return to NIH every 2 years for~     scans and x-rays to monitor their condition.~   "
267806|NCT00062140|"~     RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may~     decrease side effects while stopping cancer cells from dividing so they stop growing or die.~     Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation~     may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy~     used to kill cancer cells.~      PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide~     combined with total-body irradiation and donor stem cell transplantation in treating patients~     who have hematologic cancer.~   "
267807|NCT00062127|"~     Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in~     chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they~     stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. This~     randomized phase I trial is studying the side effects and best way to give irinotecan and~     thalidomide in treating patients with metastatic or unresectable solid tumors~   "
267808|NCT00062114|"~     RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can~     locate cancer cells and either kill them or deliver radioactive cancer-killing substances to~     them without harming normal cells.~      PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan~     together with rituximab works in treating patients with progressive non-Hodgkin's lymphoma.~   "
267809|NCT00062101|"~     This phase II trial is studying how well giving erlotinib together with celecoxib works in~     treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib~     and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor~     cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor.~     Combining erlotinib with celecoxib may kill more tumor cells.~   "
267810|NCT00062075|"~     This phase II trial is studying how well romidepsin works in treating patients with relapsed~     or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as romidepsin, work in~     different ways to stop tumor cells from dividing so they stop growing or die.~   "
267811|NCT00062062|"~     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer~     cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and~     paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die.~     Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with~     carboplatin and paclitaxel works in treating older patients with unresectable or metastatic~     non-small cell lung cancer.~   "
267812|NCT00062049|"~     RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in~     treating patients with refractory solid tumors.~   "
267813|NCT00062036|"~     RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and fludarabine use different~     ways to stop tumor cells from dividing so they stop growing or die. Inserting the gene for~     interleukin-2 into a person's tumor infiltrating lymphocytes may make the body build an~     immune response to kill tumor cells. Combining cyclophosphamide and fludarabine with~     gene-modified tumor cells may kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of gene-modified~     tumor infiltrating lymphocytes when given together with cyclophosphamide and fludarabine and~     to see how well they work in patients with metastatic melanoma (phase I is closed to accrual~     3/29/06).~   "
267814|NCT00062023|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or~     ursodiol is more effective in preventing colorectal cancer.~      PURPOSE: This randomized phase II trial is studying how well sulindac works compared to~     aspirin or ursodiol in preventing colorectal cancer.~   "
267815|NCT00062010|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Some tumors become resistant to~     chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may~     reduce resistance to the drug and allow the tumor cells to be killed.~      PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin~     together with paclitaxel works in treating patients with recurrent small cell lung cancer.~   "
267830|NCT00033462|"~     Phase II trial to study the effectiveness of erlotinib in treating patients who have~     unresectable liver, bile duct, or gallbladder cancer. Biological therapies such as erlotinib~     may interfere with the growth of cancer cells and slow the growth of the tumor.~   "
267816|NCT00061997|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Inositol may be effective in preventing the development~     of lung cancer in patients with bronchial epithelial dysplasia.~      PURPOSE: This phase I trial is studying the side effects and best dose of inositol in~     preventing lung cancer in current or former smokers with bronchial epithelial dysplasia.~   "
267817|NCT00061984|"~     RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways~     to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors,~     such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether~     doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating~     soft tissue sarcoma.~      PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well~     it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in~     treating patients with locally advanced or metastatic soft tissue sarcoma.~   "
267818|NCT00061958|"~     This phase II trial is studying how well arsenic trioxide works in treating patients with~     metastatic or unresectable cancer of the esophagus or gastroesophageal junction. Drugs used~     in chemotherapy such as arsenic trioxide use different ways to stop tumor cells from dividing~     so they stop growing or die~   "
267819|NCT00061945|"~     This phase I/II trial studies the side effects and best dose of alemtuzumab when given~     together with combination chemotherapy and to see how well it works in treating patients with~     untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs~     used in chemotherapy also work in different ways to kill cancer cells or stop them from~     growing. Giving alemtuzumab together with combination chemotherapy may be a better way to~     block cancer growth.~   "
267820|NCT00061932|"~     This phase II trial is studying how well bortezomib with or without irinotecan works in~     treating patients with gastroesophageal junction or stomach cancer that can not be removed by~     surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan~     may kill more tumor cells.~   "
267821|NCT00061919|"~     RATIONALE: Drugs used in chemotherapy such as carboplatin and etoposide use different ways to~     stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth~     of cancer by stopping blood flow to the tumor. It is not yet known if combination~     chemotherapy is more effective with or without thalidomide in treating small cell lung~     cancer.~      PURPOSE: This randomized phase III trial is studying carboplatin, etoposide, and thalidomide~     to see how well they work compared to carboplatin and etoposide in treating patients with~     limited- or extensive-stage small cell lung cancer.~   "
267822|NCT00061906|"~     RATIONALE: Celecoxib may stop the growth of thyroid cancer by stopping blood flow to the~     tumor and by blocking the enzymes necessary for tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have~     progressive metastatic differentiated thyroid cancer.~   "
267823|NCT00061893|"~     RATIONALE: Drugs used in chemotherapy, such as vinblastine, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of~     Ewing's sarcoma by stopping blood flow to the tumor. Combining more than one chemotherapy~     drug with celecoxib may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining low-dose vinblastine and~     celecoxib with standard regimens of combination chemotherapy in treating patients who have~     newly-diagnosed metastatic Ewing's sarcoma family of tumors.~   "
267824|NCT00061880|"~     RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for~     cancer cell growth.~      PURPOSE: Phase I/II trial to study the effectiveness BCX-1777 in treating patients who have~     refractory cutaneous T-cell lymphoma.~   "
267825|NCT00061867|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to~     stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills~     tumor cells by heating them to several degrees above body temperature. Combining liposomal~     doxorubicin with microwave thermotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of liposomal~     doxorubicin when given together with microwave thermotherapy in treating patients with~     prostate cancer.~   "
267826|NCT00061854|"~     RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who~     have progressive locally advanced or metastatic non-small cell lung cancer.~   "
267827|NCT00061841|"~     This project will determine whether exposing youths to a fitogenic after-school environment~     that emphasizes vigorous exercise and healthy snacks will have a favorable effect on body~     composition (i.e., less fat tissue and more lean tissue), cardiovascular fitness and~     cardiovascular disease risk profile. The environmental intervention will be provided in nine~     schools in Augusta, Georgia, with another nine schools serving as non-intervention comparison~     schools. Children in the 3rd grade will be recruited to participate. They will be followed~     for 3 years, through the 5th grade. Measurements will be made at the beginning and end of~     each school year. The 2-hour after-school intervention will be offered every school day. It~     will consist of three components: (1) homework assistance; (2) a healthy snack; and (3)~     exercise designed to improve skills and fitness.~   "
267828|NCT00061828|"~     Biliary atresia and idiopathic neonatal hepatitis are the most common causes of jaundice and~     hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Biliary~     Atresia Research Consortium (BARC) is to establish a database of clinical information and~     serum and tissue samples from children with biliary atresia (BA) and idiopathic neonatal~     hepatitis (INH) to facilitate research and to perform clinical, epidemiological and~     therapeutic trials in these two important pediatric liver diseases.~   "
267829|NCT00061815|"~     The purpose of this study is to compare overall survival in patients with previously-treated~     metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with~     oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.~   "
267831|NCT00010231|"~     RATIONALE: Combining calcitriol with dexamethasone may increase the effectiveness of therapy~     by making cancer cells more sensitive to dexamethasone.~      PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with dexamethasone~     in treating patients who have prostate cancer that has not responded to previous hormone~     therapy.~   "
267832|NCT00010114|"~     RATIONALE: Genetic studies may help in understanding the genetic processes involved in the~     development of some types of cancer.~      PURPOSE: Genetic study to learn more about genes involved in the development of central~     nervous system tumors in young children.~   "
267833|NCT00009932|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining fenretinide, paclitaxel, and~     cisplatin in treating patients who have solid tumors that have not responded to previous~     therapy.~   "
267834|NCT00009802|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Calcitriol may increase the effectiveness of paclitaxel by making~     tumor cells more sensitive to the drug.~      PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with paclitaxel in~     treating patients who have advanced solid tumors.~   "
267835|NCT00061802|"~     A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in~     patients with an acute exacerbation of either schizophrenia or schizoaffective disorder~   "
267836|NCT00009789|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy~     in treating patients who have stage I non-small cell lung cancer and lung dysfunction.~   "
267837|NCT00008424|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children with~     refractory or advanced solid tumors who are receiving anticonvulsants.~   "
267838|NCT00008398|"~     RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation~     therapy for head and neck cancer. It is not yet known if sargramostim is more effective than~     no treatment in reducing mucositis caused by radiation therapy.~      PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in~     decreasing mucositis in patients who are receiving radiation therapy for head and neck~     cancer.~   "
267839|NCT00008203|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or~     bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs~     and kill more tumor cells. Biological therapy may interfere with the growth of the cancer~     cells. It is not yet known which post-transplant biological therapy regimen is more effective~     for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine and~     interferon gamma to that of interleukin-2 following combination chemotherapy and bone marrow~     or peripheral stem cell transplantation in women who have stage II or stage III breast~     cancer.~   "
267840|NCT00008112|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Hyperthermia therapy kills tumor cells by heating them to several degrees above body~     temperature. Combining hyperthermia with radiation therapy and chemotherapy may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cisplatin combined with radiation~     therapy and hyperthermia in treating patients who have stage II, stage III, or stage IV~     cervical cancer.~   "
267841|NCT00061789|"~     This study will use single photon emission computed tomography (SPECT) to study brain~     nicotine receptors (proteins on the surface of brain cells) in healthy subjects and in~     patients with schizophrenia. Autopsy findings in patients with schizophrenia show changes in~     their nicotine receptors. This study will use SPECT to look at these receptors in living~     schizophrenia patients and compare them with those in healthy subjects.~      The following individuals between 21 and 50 years of age (or between 21 and 80 years of age~     for Group 1 only) are eligible for this study: healthy non-smokers (Group 1); schizophrenia~     patients who smoke (Group 2); schizophrenia patients who do not smoke (Group 3); healthy~     smokers (Group 4); healthy non-smokers (Group 5). Patients with schizophrenia must be taking~     olanzapine (Zyprexa) or risperidone (Risperdal) for at least 6 months. All candidates will be~     screened at the first visit. Group 1 participants will have three more visits; Groups 2~     through 5 will have two more visits.~      Visit 1~      All participants will be screened with physical and neurological examinations; blood and~     urine tests; and neuropsychological tests to assess their ability to learn and remember words~     and numbers, to pay attention, and to quickly perform motor tasks, such as putting pegs into~     a piece of wood. In addition, they will have an eye movement test and event-related potential~     testing. For the eye test, the subject sits in a chair and leans forward with the chin on a~     chin rest. A band is tied around the head and very small amounts of invisible (infrared)~     light are shined into the eyes. The light is reflected back and measured. Wire electrodes are~     placed around the area of the eye and cheek to monitor eye blinks and eye movements. Subjects~     are asked to follow a light with their eyes and to look away from a light. For event- related~     potential testing, electrodes are placed on the scalp, forehead and cheeks, and brain~     activity is recorded while the subject identifies particular pictures and sounds.~      Visit 2 (and Visit 3 for Group 1)~      Participants will have a SPECT scan. On the night before the scan, the day of the scan, and~     for 4 days after the scan, subject take an oral dose of potassium iodide to protect the~     thyroid gland from the radioactive tracer used in the SPECT procedure. (Individuals allergic~     to potassium iodide will take potassium perchlorate instead.) For the SPECT scan, small~     radioactive markers containing 99mTc are glued to the subject's head. Two catheters (thin,~     flexible tubes) are placed in veins in the arms to inject the radioactive tracer~     [123I]5-I-A-85380 and to draw blood samples. During the scan, the subject lies on a bed with~     his or her head held still with a headholder. The scans are taken over a 9-hour period after~     injection of the tracer injection. An electrocardiogram, respiration, and blood pressure~     measures are taken before injection of [123I]5-I-A-85380, then 5 minutes after the injection,~     and again 30 to 60 minutes after the injection. Breath samples are collected every 60~     minutes. Blood and urine samples are collected 5 to 6 hours after starting the scan. Group 1~     subjects will have a second SPECT scan within 4 weeks of the first.~      Visit 3 (Visit 4 for Group 1)~      Participants will have a magnetic resonance imaging (MRI) scan. For this procedure, the~     subject lies on a table that slides into a narrow metal cylinder with a strong magnetic field~     for the scan. The scanner uses a magnetic field and radio waves to produce images that show~     structural and chemical changes in tissues. The test lasts up to 1 hour.~   "
267842|NCT00061776|"~     The purpose of the study is determine if an investigational drug, NGX-4010~     (high-concentration capsaicin dermal patches) is effective in treating pain associated with~     post-herpetic neuralgia (PHN).~   "
267843|NCT00061763|"~     The purpose of this study is to determine the effects of the oral iron chelator Deferasirox~     on liver iron content after one year of treatment in patients with iron overload from~     repeated blood transfusions. Beta-thalassemia patients unable to be treated with deferoxamine~     or patients with rare chronic anemias such as Myelodysplastic Syndrome, Fanconi's Syndrome,~     Blackfan-Diamond Syndrome, and Pure Red Blood Cell Anemia are eligible for this study. Liver~     iron content will be measured by liver biopsy at the beginning of the study and after one~     year of treatment. However, those patients living in the San Francisco/Oakland area may have~     a SQUID in place of the liver biopsy if the biopsy is not medically possible for them. The~     SQUID is a non-invasive magnetic means to measure liver iron content.~   "
267844|NCT00061750|"~     The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is~     as effective and as safe as deferoxamine in preventing accumulation of iron in the body while~     a patient is undergoing repeated blood transfusions.~   "
267845|NCT00061737|"~     Measurement of the quality of life (QoL) of children and adolescents with inflammatory bowel~     diseases (IBD) has had little attention, despite the importance of understanding key factors~     affecting QoL, especially for measuring the effects of clinical trials to improve IBD~     outcomes. The main purpose of this pilot study is to examine the impact of clinical severity~     and treatment social factors on the quality of life (QoL) of a diverse population of children~     and adolescents with inflammatory bowel disease (IBD). Secondary purposes include determining~     the effects of sociodemographic factors on QoL and exploring the concordance of views of~     parents and children of QoL. The study aims are to 1) determine the associations of of~     clinical characteristics (condition type, activity/severity, and treatment) with specific~     components of general health-related quality of life and IBD-specific QoL; 2) describe the~     effects of sociodemographic characteristics (SES, age, and gender) on these measures; and 3)~     compare the views of different observers (parent and child with IBD) of the child's QoL. The~     study will apply both general and condition-specific QoL measures among a random sample of~     250 children and adolescents with IBD, ages 5-18 years, in six clinical sites. We will obtain~     measures of QoL from both the child and a parent in each case. The study will obtain~     additional data regarding the subjects' clinical condition (condition type,~     severity/activity, treatment [including surgery], age of onset) and socioeconomic status~     (household structure and income). Main analyses will compare general and specific measures of~     QoL and examine the influence of clinical and sociodemographic variables on QoL, through~     multivariate regression techniques. We will also examine the differences in child and parent~     assessments of QoL. The information from this study will provide a stronger base for future~     studies of treatment and natural history of IBD. It will help to clarify the life domains~     that are affected by IBD and will inform interventions to improve QoL for children with IBD.~   "
267866|NCT00006457|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer.~      PURPOSE: Randomized phase I trial to study the effectiveness of oltipraz in preventing lung~     cancer in people who smoke.~   "
267846|NCT00061724|"~     The purpose of this project is to lay the groundwork for a proposed clinical trial to compare~     the effectiveness of two approaches to gastroesophageal reflux disease: treatment with~     medications and treatment with anti-reflux surgery. This project includes a~     non-interventional pilot study to test ways of measuring outcomes of treatment, and to gauge~     potential participants' willingness to enroll in the proposed clinical trial.~   "
267847|NCT00061711|"~     This randomized, controlled trial will evaluate the efficacy and safety of three alternative~     approaches utilizing phytoestrogens to treat hot flashes and night sweats in peri- and~     post-menopausal women. The treatments were chosen because of the scientific evidence~     supporting a possible benefit, the availability of products with adequate quality control,~     and their frequency of use in naturopathic medicine. RECRUITMENT FOR THIS STUDY SHOULD END BY~     AUGUST 1, 2003.~   "
267848|NCT00061698|"~     This study will compare the effectiveness of three therapies for the treatment of depression~     in preadolescent girls.~   "
267849|NCT00061672|"~     The primary objective of this study is to assess the safety and effectiveness of ABT-510 in~     subjects with refractory lymphoma.~   "
267850|NCT00061659|"~     The primary objective of this study is to assess the safety and effectiveness of ABT-510 in~     subjects with locally advanced or metastatic soft tissue sarcoma.~   "
267851|NCT00061646|"~     The primary objective of this Phase II study is to assess the safety, pharmacokinetics and~     effectiveness of ABT-510 in combination with standard carboplatin/paclitaxel chemotherapy in~     subjects with stage IIIb or IV NSCLC.~   "
267852|NCT00051714|"~     The purpose of this study is to examine the immediate and long-term effects of a prevention~     program in children at risk for developing conduct problems and antisocial behavior.~   "
267853|NCT00061633|"~     Serious infections caused by resistant bacteria are becoming more of a medical problem~     throughout the world. One of the ways to deal with this problem is to develop new drugs that~     can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control~     infections and whether this drug can be safely given to patients.~   "
267854|NCT00061620|"~     The goal of this clinical research study is to find the highest dose of Tezacitabine (FMdC)~     which can be safely given as a continuous infusion by vein to patients with hematologic~     malignancies. The general safety and effectiveness of this drug will also be studied.~   "
267855|NCT00059462|"~     The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in~     HIV positive patients receiving HAART and to test the drug's effect on the CD4+ T-cell count.~   "
267856|NCT00008021|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use~     different ways to stop cancer cells from dividing so they stop growing or die. Peripheral~     stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill~     more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy,~     cyclosporine, and paclitaxel followed by peripheral stem cell transplantation in treating~     patients who have refractory non-Hodgkin's lymphoma.~   "
267857|NCT00006864|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer~     cells.~      PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who~     have metastatic kidney cancer.~   "
267858|NCT00006484|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective for non-small cell lung~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus~     paclitaxel with or without tirapazamine in treating patients who have stage IIIB or stage IV~     non-small cell lung cancer.~   "
267859|NCT00061607|"~     Spinal muscular atrophy (SMA) is a disorder that affects the motor neurons. SMA is caused by~     a mutation in a part of the DNA called the survival motor neuron (SMN1) gene, which normally~     produces a protein called SMN. Because of their gene mutation, people with SMA make less SMN~     protein, which results in the loss of motor neurons. SMA symptoms may be improved by~     increasing the levels of SMN protein. The purpose of this study is to determine whether a~     drug called a histone deacetylase inhibitor can increase SMN levels.~      After undergoing a general medical and neurological evaluation, study participants will~     donate a blood sample. Researchers will use this sample to measure SMN levels. They will also~     isolate cells from the blood and treat the cells with various drugs that may increase SMN~     levels.~   "
267860|NCT00061594|"~     This is a phase III, multicenter, randomized, double-masked, active treatment-controlled~     study of intravitreally administered ranibizumab compared with verteporfin (Visudyne)~     photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.~   "
267861|NCT00061542|"~     The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol~     Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8~     pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure~     and pulse checks at each visit. Patients will have a dilated fundus exam and corneal~     measurements taken at first and last visit.~   "
267862|NCT00061529|"~     The primary objective of this study is to compare the safety and efficacy of Brimonidine~     Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular~     hypertension.~   "
267863|NCT00061516|"~     The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in~     pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve~     weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at~     each visit. Patients will have a dilated fundus exam and corneal measurements taken at first~     and last visit.~   "
267864|NCT00061503|"~     The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic~     Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle~     glaucoma (OAG) or ocular hypertension (OHT).~   "
267865|NCT00006464|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of UCN-01 and cisplatin in treating~     patients who have advanced or metastatic solid tumors.~   "
267867|NCT00006383|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal vincristine in treating~     patients who have refractory or relapsed non-Hodgkin's lymphoma.~   "
267868|NCT00006377|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin, paclitaxel, and~     carboplatin in treating patients who have primary stage III, stage IV, or recurrent~     endometrial cancer.~   "
267869|NCT00006361|"~     RATIONALE: SU5416 may stop the growth of cancer cells by stopping blood flow to the tumor.~      PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have~     advanced or recurrent cancer of the head and neck.~   "
267870|NCT00061581|"~     Bone marrow transplantation (BMT) is a risky procedure. If doctors could reduce the~     complications, BMT would be safer to use for a wider range of conditions. The purposes of~     this study are~        -  to prevent graft rejection by increasing the amount of immunosuppression and by giving~          some lymphocytes from the donor before transplant;~        -  to prevent graft-versus-host disease (GVHD) by transplanting T-cell depleted stem cells;~        -  to improve the immune effect against residual leukemia by the add-back of donor~          lymphocytes before transplant and six or more weeks after transplant.~      Beyond the standard transplant protocol, study participants will undergo additional~     procedures. First, along with total body irradiation, patients will receive two drugs (a high~     dose of cyclophosphamide and fludarabine) to suppress immunity and prevent rejection of the~     transplant. Second, four days before the transplant, patients will be given donor lymphocytes~     that have been irradiated to make them incapable of causing GVHD. On the day of the~     transplant, patients will receive an infusion of T-cell depleted bone marrow stem cells.~     Finally, patients will receive two doses of add-back donor T-cells (45 and 100 days post~     transplant) and the immunosuppressive drug cyclosporine starting on day 44 until about six~     months after transplant.~      Study participants must be between the ages of 10 and 56 and have a family member who is a~     suitable stem cell donor match.~   "
267871|NCT00061568|"~     People with severe congenital anemias, such as sickle cell anemia and beta-thalassemia, have~     been cured with bone marrow transplantation (BMT). The procedure, however, is limited to~     children younger than the age of 16 because the risks are lower for children than for adults.~      The purpose of this study is to explore the use of a BMT regimen that, instead of~     chemotherapy, uses a low dose of radiation, combined with two immunosuppressive drugs. This~     type BMT procedure is described as nonmyeloablative, meaning that it does not destroy the~     patient s bone marrow. It is hoped that this type of BMT will be safe for patients normally~     excluded from the procedure because of their age and other reasons.~      To participate in this study, patients must be between the ages of 18 and 65 and have a~     sibling who is a well-matched stem-cell donor. Beyond the standard BMT protocol, study~     participants will undergo additional procedures. The donor will receive G-CSF by injection~     for five days; then his or her stem cells will be collected and frozen one month prior to~     BMT. Approximately one month later, the patient will be given two immune-suppressing drugs,~     Campath 1-H and Sirolimus, as well as a single low dose of total body irradiation and then~     the cells from the donor will be infused.~      Prior to their participation in this study, patients will undergo the following evaluations:~     a physical exam, blood work, breathing tests, heart-function tests, chest and sinus x-rays,~     and bone-marrow sampling.~   "
267872|NCT00061490|"~     This study will evaluate whether a program of weight loss and exercise can help individuals~     with knee osteoarthritis (OA).~   "
267873|NCT00061477|"~     The purposes of this study are to determine:~        1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated~          with the combination of these two drugs.~        2. Whether Pemetrexed plus Gemcitabine can help patients with mesothelioma live longer.~        3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how~          long.~        4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.~   "
267874|NCT00061464|"~     The purposes of this study are to determine:~        1. The safety of pemetrexed plus Gemcitabine and any side effects that might be associated~          with the combination of these two drugs.~        2. Whether pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer~          live longer.~        3. Whether pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how~          long.~        4. To see if patients feel better while taking pemetrexed plus Gemcitabine.~   "
267875|NCT00061451|"~     The purposes of this study are to determine:~        1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated~          with the combination of these two drugs.~        2. Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer~          live longer.~        3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how~          long.~        4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.~   "
267876|NCT00006349|"~     RATIONALE: Donepezil and vitamin E may be able to decrease side effects caused by radiation~     therapy given to prevent brain metastases in patients with small cell lung cancer. It is not~     yet known if donepezil and vitamin E are effective in preventing side effects caused by~     radiation therapy to the head.~      PURPOSE: Randomized phase III trial to determine the effectiveness of donepezil and vitamin E~     in preventing side effects caused by radiation therapy given to prevent brain metastases in~     patients who have small cell lung cancer.~   "
267877|NCT00006341|"~     RATIONALE: The use of dentures and dental implants may help maintain chewing and speaking~     ability following surgery to remove tumors in the mouth.~      PURPOSE: Phase II trial to study the effectiveness of dentures and dental implants in~     maintaining the ability to chew and speak in patients undergoing surgery for mouth cancer.~   "
267901|NCT00061178|"~     The purpose of this study is to determine whether rhuMAb VEGF (Bevacizumab) is safe and~     effective for the treatment of renal cell cancer when other treatments have failed.~   "
267919|NCT00006095|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vincristine plus irinotecan in treating~     children who have solid tumors that have not responded to previous therapy.~   "
267878|NCT00061438|"~     This is a research study in patients having a condition known as necrotizing pancreatitis.~     This is inflammation of the pancreas (an intestinal organ which assists with digestion) that~     has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic~     tissue may develop a bacterial infection, which can cause further -sometimes very serious-~     health problems.~      It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that~     is - to provide protection before any infection starts). However, it is not certain that this~     antibiotic therapy will be successful.~      This study is being carried out to see whether the antibiotic 'Meropenem' (which is also~     known as MERREM I.V.) provides protection from developing a pancreatic infection. This will~     be done by comparing the progress of patients who receive meropenem with those who receive a~     non-active placebo solution (a solution that does not contain any active medication).~      Meropenem or placebo would be given in addition to the standard treatment received for~     pancreatitis.~      It is not known if meropenem will help prevent infections associated with necrotizing~     pancreatitis.~      Approximately 240 patients will take part in this study.~      Study participation will be carried out for up to 6 weeks, and patients will receive the~     study treatment up to a maximum of 21 days.~   "
267879|NCT00061425|"~     The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized~     (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma~     (NHL) at different dose levels.~   "
267880|NCT00061412|"~     This project is evaluating programs to improve reading and writing skills in children who~     have or are at risk for having reading disabilities. The project focuses on children who are~     at-risk for low achievement in school and on children with dyslexia.~   "
267881|NCT00061399|"~     Prospective memory (PM) is memory to complete future tasks, such as recalling to give a note~     to someone when you next see them, pick up milk on the way home, or remembering to keep an~     appointment. This study will evaluate PM in children with traumatic brain injury (TBI).~   "
267882|NCT00061386|"~     This study will evaluate a community-based program to improve diet and physical activity in~     women during the first 12 months following the birth of a child. The program is designed to~     complement existing federal programs for low-income families and is directed toward~     low-income, postpartum, multi-ethnic women.~   "
267883|NCT00061321|"~     Infants who are breast-fed by HIV infected mothers have an increased risk of becoming~     infected with HIV. Standard therapy for the prevention of HIV infections in infants included~     zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women~     during labor, and a single dose of NVP for newborns given 72 hours after birth. This study~     will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in~     addition to standard therapy, will be more effective than standard therapy alone at~     preventing HIV infections in these infants.~   "
267884|NCT00061308|"~     This research study was designed to determine the effectiveness of the drug, topotecan, given~     intravenously (into a vein) together with the drug gemcitabine in patients with recurrent~     platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of~     mixed mullerian origin. Additional purposes are to determine the long term outcome and side~     effects of this combination treatment.~      Since topotecan and gemcitabine have different mechanisms of action, the combination of these~     2 drugs may provide better results than either drug alone. Prior studies suggest that the~     combination of topotecan and gemcitabine improves the effects on the tumor and also appeared~     to be well tolerated.~   "
267885|NCT00061295|"~     Body weight support (BWS) treadmill training uses an overhead harness to give partial support~     to patients walking on a treadmill. This study will determine whether BWS training is more~     effective than conventional rehabilitation therapy in improving walking ability in patients~     with spinal cord injuries (SCI).~   "
267886|NCT00045149|"~     RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to~     stimulate the immune system and stop cancer cells from growing. Treating a person's white~     blood cells in the laboratory and then reinfusing them may cause a stronger immune response~     and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients~     who have metastatic melanoma.~   "
267887|NCT00019734|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with and~     without interleukin-2 in treating patients who have metastatic melanoma that has not~     responded to previous treatment.~   "
267888|NCT00061373|"~     Ischemic stroke is caused by a blood clot that blocks the flow of blood to the brain and~     damages brain cells. The clot, or thrombus, is made up of platelets and fibrin. The medicine~     alteplase, also known as tPA , is the standard drug used to treat patients with acute~     ischemic stroke. tPA attacks the fibrin portion of the blood clot. While intravenous (iv) tPA~     alone is effective in treating the fibrin part of the clot approximately 30% of the time,~     adding other commercially available drugs such eptifibatide to treat other clot components~     may improve the effectiveness of iv tPA therapy.~      This is a clinical trial to determine an acceptable dose of eptifibatide in combination with~     aspirin, the low molecular weight heparin tinzaparin, and standard iv tPA therapy for the~     treatment of acute ischemic stroke. Use of clinical and imaging based selection criteria are~     hypothesized to contribute to treatment safety by selecting patients at lower risk of~     intracerebral hemorrhage. Also,selection and evaluation of patients by magnetic resonance~     imaging (MRI) criteria will result in a different risk to benefit ratio than selecting~     patients without MRI criteria and will lead to a different acceptable dose.~   "
267889|NCT00061360|"~     Severe aplastic anemia (SAA) is a life-threatening bone marrow failure disorder characterized~     by pancytopenia and a hypocellular bone marrow. Allogeneic bone marrow transplantation and~     immunosuppressive treatment with anti-thymocyte globulin (ATG) and cyclosporine (CsA) have~     dramatically changed the natural course of this illness, with 5 year survival of 75% in~     patients undergoing either treatment. Since most patients are not suitable candidates for~     hematopoietic stem cell transplantation (HSCT) due to advanced age or lack of a~     histocompatible sibling, efforts at NHLBI have focused on improving immunosuppression~     treatment in order to improve response rates, survival, and to decrease relapse.~      In our experience of 122 patients treated at NHLBI with the combination of ATG and~     cyclosporine, one quarter to one third did not respond; about 50% of responders relapsed; and~     5 year survival was correlated with the robustness in blood cell count improvement at 3~     months (reticulocyte or platelet count greater than or equal to 50,000 /uL). Why some~     patients do not respond initially while others relapse is unclear. Autoreactive T cells may~     be resistant to the effect of ATG/CsA (nonresponders), while in others residual autoreactive~     T cells expand post-treatment leading to hematopoietic stem cell destruction and recurrent~     pancytopenia (relapse). Therefore, novel immunosuppressive regimens to increase response~     rates and hematologic recovery at 3 months and to decrease relapse rates are needed. An~     ongoing NHLBI trial, which is close to completing accrual, has added mycophenolate mofetil~     (MMF) for a total of 18 months to standard ATG + CsA in an attempt to reduce the relapse rate~     after cyclosporine is discontinued. Preliminary results have been disappointing, with no~     marked reduction in relapse among patients who received MMF.~      Sirolimus (rapamycin, Rapamune , RAPA) is a novel immunosuppressive agent, which acts~     synergistically with cyclosporine by blocking T cell activation through CsA-resistant~     pathways. The potentiation of the combination of CsA-RAPA has been established in vitro and~     in the clinical setting, mainly in islet cell and solid organ transplantation. The~     significant increase in response rate seen with the addition of CsA to ATG indicated that an~     inhibitory effect on T lymphocytes is important in blocking autoreactive T cells in aplastic~     anemia. The combination of CsA-RAPA may further block activated autoreactive T cells and~     therefore lead to improved response rates (and survival) and decreased relapse rates.~      This prospective randomized phase II study will investigate two different immunosuppressive~     regimens in patients with severe aplastic anemia who have not received prior~     immunosuppressive therapy. One arm will receive ATG + CsA in addition to sirolimus for 6~     months, and the second arm will receive standard ATG + CsA for 6 months followed by a slow~     taper of CsA with a 25% dose reduction every 3 months for the subsequent 18 months. This~     trial will determine the effectiveness of sirolimus in patients with aplastic anemia as well~     as the role of a cyclosporine taper in preventing relapses. Primary endpoint will be no~     longer meeting criteria for severe aplastic anemia while secondary endpoints are relapse,~     robustness of hematologic recovery at 3 months, survival, clonal evolution to PNH,~     myelodysplasia and acute leukemia.~      10/11/2005. The Sirolimus (Rapamune) arm of the trial was stopped for lack of efficacy. The~     study will continue as a single arm study to establish if slow taper of CsA prevents relapse~     rates after initial standard treatment with ATG followed by CsA for six months.~   "
267917|NCT00006243|"~     This randomized pilot clinical trial studies vaccine therapy and sargramostim in treating~     patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens~     may help the body build an effective immune response to kill tumor cells. Colony-stimulating~     factors, such as sargramostim, increase the number of white blood cells and platelets found~     in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be~     an effective treatment for malignant melanoma~   "
267918|NCT00006242|"~     Phase I trial to study the effectiveness of BMS-214662 in treating patients who have advanced~     solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die~   "
267890|NCT00061347|"~     To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the~     prostate gland during radiation therapy. To help improve this view, doctors may insert gold~     markers called fiducials into the prostate by placing hollow gold needles through the rectum~     and moving a fiducial through each needle. The purpose of the study is to determine whether~     an MRI scan can help doctors improve their placement of these needles.~      Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin~     for two days prior to the placement of the fiducials, then will have a small enema and~     another dose of the antibiotic on the morning of the procedure. After being anesthetized,~     patients will have an antenna-like tube placed into the rectum and have MRI images taken of~     the area. The doctor will then use these scans to place four fiducials into the prostate. The~     procedure will require approximately 45 minutes. Patients will be allowed to go home the same~     day of the procedure, which will be followed by a seven-week course of standard radiation~     therapy.~      Prior to their participation in this study, patients will undergo the following evaluations:~     a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.~   "
267891|NCT00061334|"~     The purpose of the protocol is to localize the neural regions and systems mediating the forms~     of knowledge representations hypothesized by the principal investigator to be stored in the~     human prefrontal cortex. Utilizing a variety of experimental neuropsychological tasks during~     functional MRI, we will investigate hypotheses regarding the role of the dorsolateral and~     ventromedial prefrontal cortex in social cognition and emotional processing. We will~     ascertain the relationship between so-called cold cognition such as event knowledge and hot~     social cognition such as attitude formation and specific brain regions within the prefrontal~     cortex. We will also attempt to determine the relationship between non-frontal neural~     structures involved in emotional expressions, such as amygdala, and those frontal neural~     structures involved in executive functions that may modulate emotion. The data that we~     collect in this protocol will be of value in (1) identifying a set of neural regions and~     distributed networks mediating the forms of knowledge representation stored in the prefrontal~     cortex and (2) developing functional MRI screening measures for subjects at-risk for~     developing a neurological disorder. We will also use the data obtained in these studies with~     healthy adult volunteers to constrain theories of frontal lobe function based on the study of~     patients with focal or diffuse frontal lobe lesions and to provide convergent evidence for~     the role of specific frontal cortex sectors in specific cognitive functions.~   "
267892|NCT00061282|"~     Colectomy with creation of an ileal pouch (IPAA) is now the treatment of choice for patients~     with ulcerative colitis that is resistant to existing medical therapies. The development of~     inflammation in these ileal reservoirs, a clinical entity referred to as pouchitis, is the~     most common long-term complication of this procedure and can affect 50-60% of adults and~     children. We have previously demonstrated that clotrimazole (delivered as a rectal~     suppository) is generally safe, effective, and displays poor systemic absorption when used in~     pediatric and adults with active pouchitis. We saw clinical benefit in patients with pouch~     disease that had previously failed to respond to standard antibiotic, steroid, or~     immunosuppressive therapies. The clinical trial outlined here will define the effectiveness~     and safety of topical clotrimazole therapy (delivered as a rectal enema) in pediatric (aged~     greater than two years) and adult patients with pouchitis.~      Subjects in this study will be randomly assigned to receive either placebo (no active drug, 4~     subjects) or one of two clotrimazole therapy groups: 2500 mg/day (8 subjects) or 4000mg/day~     (8 subjects). No washout period is required, and subjects will be allowed to continue their~     existing anti-inflammatory medications during their participation in the study. Clotrimazole~     will be delivered nightly in the form of an enema. Subjects will undergo flexible~     sigmoidoscopy (pouchoscopy) prior to and again after completing one month of study therapy,~     and pouch disease activity will be graded at after each procedure using the Pouchitis Disease~     Activity Index (PDAI). Clinical improvement will be defined as a drop in PDAI score. If the~     drop in PDAI scores between placebo and either active clotrimazole treatment group is not~     significant, and no subject experiences what are determined to be study-related adverse~     effects, a second cohort of subjects will be recruited and studied after receiving one month~     of either placebo (4 subjects), 6000 mg/day clotrimazole (8 subjects), or 7500mg/day~     clotrimazole (8 subjects).~      Subjects will be assessed for adverse effects at the midpoint of the study. Clotrimazole~     blood levels will be measured during the first and last day of study participation. In~     addition, adults will complete a health related quality of life assessment at baseline and~     after completing study drug therapy.~      All subjects will be eligible for one month of open-label study drug therapy after completing~     one month of study drug therapy.~   "
267893|NCT00041353|"~     RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for~     breast cancer may improve the ability to detect breast cancer cells early and plan effective~     treatment.~      PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration~     specimens from women at increased or normal risk of breast cancer.~   "
267894|NCT00019175|"~     RATIONALE: Vaccines made from an antigen combined with a modified virus may make the body~     build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white~     blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may kill~     more tumor cells.~      PURPOSE: Phase I trial to compare the effectiveness of vaccine therapy with or without~     interleukin-2 in treating patients who have recurrent metastatic melanoma that has not~     responded to previous therapy.~   "
267895|NCT00002786|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing.~      PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating~     patients who have metastatic melanoma.~   "
267896|NCT00061269|"~     The VARD (Videoendoscopic Assisted Retroperitoneal Drainage) approach as treatment for~     necrotizing pancreatitis proposes an alternative to standard complicated open abdomen~     treatment methods.~      This treatment involves making a small incision and looking inside the abdomen with a~     videoendoscope. A videoendoscope is an instrument with a small camera and light on the end.~     It also has an extension tool that the surgeon can use to clean out any dead and infected~     tissue in the abdomen.~      This approach may reveal a treatment opportunity with faster recovery potential and shorter~     hospitalizations for patients with necrotizing pancreatitis.~   "
267897|NCT00061256|"~     Alendronate is a drug that is used to treat osteoporosis. The purpose of this study is to~     examine whether alendronate in combination with calcium and vitamin D is safe and effective~     for treating bone loss in people with HIV.~   "
267898|NCT00061243|"~     This study will evaluate the safety of and immune response to a new HIV vaccine. The vaccine~     in this trial uses pieces of HIV DNA and HIV proteins. The vaccine itself cannot cause HIV~     infection or AIDS.~   "
267899|NCT00061230|"~     This study will examine the effectiveness of relaxation training for providing pain relief~     and improving physical and psychological functioning in youth with physical disabilities due~     to cerebral palsy.~   "
267900|NCT00061217|"~     People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This~     study will evaluate a new method of making prosthetic legs for people who have had an~     amputation below the knee.~   "
267902|NCT00061165|"~     Obesity is the second leading preventable cause of disease and death in the United States.~     Low socioeconomic status (SES) and minorities are disproportionately affected. Obesity~     prevention among children and adolescents is a public health priority. Schools have been~     identified as key settings for obesity prevention; however, most health education~     interventions have had only a moderate effect on body weight. We propose a randomized~     intervention trial (pilot study) to test the feasibility and effectiveness of a school-based,~     environmental obesity prevention program in urban low-SES African American students. Schools,~     students and their families, and local communities will be involved to promote healthy eating~     and physical activity (HEPA) for prevention of childhood obesity. Six Chicago public schools~     will be randomly assigned as intervention (4 schools) and controls (2 schools). Focus group~     studies will assess needs and barriers for promotion of HEPA and guide the intervention. The~     intervention group will receive a School Environment Enrichment (SEE) program to modify the~     school physical and social environment, targeting food service, recess, physical education~     (PE) and school climate, and a Community Support & Environment Modification (CSEM) program,~     involving local corner and chain grocery stores to promote healthy eating among students and~     their families. Family involvement will be included for 5th and 6th graders, who will be~     followed for two years, to test ways to modify family environment. To assess the intervention~     effectiveness, multilevel data will be collected from schools (eg, food service, recess and~     PE), students (eg, body weight, eating and physical activity), parents (eg, family food~     purchasing practices) and communities (eg, available choices of snack foods in local stores).~     In addition, process evaluation data will be collected to assess the feasibility and~     acceptance (participation and satisfaction) of various intervention components by the target~     audience. The primary outcome variable is change in students' body weight status; secondary~     outcomes include changes in students' eating behavior and physical activity and changes in~     target environmental factors. In addition, cost-effectiveness of the intervention will be~     determined. If the intervention proves effective, a full-scale study will be developed.~     Findings from this study will provide insights into the prevention of obesity among low-SES~     and minority students.~   "
267903|NCT00019084|"~     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make~     the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's~     white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an~     effective treatment for advanced cancer.~      PURPOSE: Phase II trial to study the effectiveness of a vaccine made with the patients' white~     blood cells mixed with tumor proteins in treating patients who have advanced cancer.~   "
267904|NCT00015821|"~     Phase II trial to study the effectiveness of thalidomide in treating patients who have~     myelofibrosis. Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the~     cancer cells.~   "
267905|NCT00004868|"~     RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the~     tumor.~      PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have~     recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.~   "
267906|NCT00003408|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Combining chemotherapy and peripheral stem cell transplantation~     with biological therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of biological therapy with sargramostim,~     interleukin-2, and interferon alfa following chemotherapy and peripheral stem cell~     transplantation in treating patients who have cancer.~   "
267907|NCT00061204|"~     This study will use magnetic resonance imaging (MRI) to identify brain regions involved in~     performing certain tasks, especially those involving emotions. MRI is a diagnostic tool that~     uses a strong magnetic field and radio waves to produce images of structural and chemical~     changes in the brain. The study will also examine which MRI techniques are best to use when~     scanning brain areas involved in different emotions.~      Healthy normal volunteers between 18 and 40 years of age who are right-handed and are native~     English speakers may be eligible for this study. Individuals with a history of neurological~     disease, post-traumatic stress disorder or other psychiatric disorder, or who have a history~     of physical or sexual abuse may not participate. Candidates will be screened with a written~     questionnaire and a medical history, including psychiatric and neurological information.~      Participants will perform tasks involving emotions while undergoing MRI scanning. For this~     procedure, the subject lies on a table in a narrow metal cylinder (the scanner) containing a~     magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting~     between 45 and 90 minutes. The subject is asked to lie still for up to 10 minutes at a time.~     During the scan, the subject performs simple tasks involving the viewing of pictures on a~     screen. Other tasks involve viewing pictures and responding to them by pressing buttons. Some~     pictures are violent or pornographic, while others are pleasant to view. Of a total of 162~     pictures, 30 percent are categorized as graphic and possibly disturbing.~   "
267908|NCT00061152|"~     The purpose of the study is to gain initial information on the tolerability and feasibility~     of high-concentration capsaicin patches for the treatment of painful HIV-associated~     neuropathy, whether resulting from HIV disease and/or antiretroviral drug exposure. The study~     will also provide preliminary safety and efficacy information.~   "
267909|NCT00061139|"~     Pediatric Constraint-Induced (CI) Movement therapy is a rehabilitation program designed to~     improve motor function in children with partial paralysis. Children with cerebral palsy may~     have one arm that has significantly greater function (good arm) than the other (bad arm).~     Restricting the use of the good arm may improve the use of the bad arm. In pediatric CI~     therapy, the good arm is put in a sling to force increased use of the bad arm. The bad arm is~     also trained each day for several weeks. This study will test the ability of pediatric CI~     therapy to improve motor function in children with cerebral palsy.~   "
267910|NCT00061126|"~     A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients~     with prostate cancer with or without tumor in other parts of the body.~      Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course)~     or until evidence of progressive disease.~   "
267911|NCT00061113|"~     The purpose of this study is to evaluate the impact of treating depression on substance~     dependent teens.~   "
267912|NCT00061100|"~     The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained~     Patients.~   "
267913|NCT00061087|"~     The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD)~     in methadone patients.~   "
267914|NCT00061074|"~     The purpose of this study is to evaluate the effects of ERT on appetitive behavior and~     withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine~     replacement~   "
267915|NCT00061061|"~     The purpose of this study is to evaluate the effects of ERT on appetitive behavior and~     withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal~     female smokers.~   "
267916|NCT00061035|"~     Dr. Frederick Millard, MD, Associate Clinical Professor at the UCSD Cancer Center, will be~     conducting a 12-week study in advanced prostate cancer patients. The study will be held at~     the UCSD Medical Center and will test an experimental investigational gene therapy vaccine~     designed to make the patient's immune system react against telomerase, an enzyme expressed in~     prostate cancer cells.~   "
267920|NCT00006086|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of BMS-188797 and carboplatin in treating~     patients who have advanced nonhematologic cancer.~   "
267921|NCT00006082|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have advanced small cell lung cancer.~   "
267922|NCT00061048|"~     This study will examine the safety and effectiveness of Alemtuzumab (Campath-1H) for treating~     patients with adult T-cell leukemia/lymphoma (ATL). ATL is caused by a virus called human~     T-cell lymphotrophic virus type-1 (HTLV-1) that infects lymphocytes (white blood cells)~     called T-cells. Cancerous cells can be found not only in the blood, but also in the skin,~     lungs, lymph nodes, liver, bone, bone marrow, spleen, and meninges (tissues covering the~     brain). There are four categories of ATL, based on the aggressiveness of disease-smoldering,~     chronic, lymphoma, and acute. Campath-1H is a monoclonal antibody that attaches to and kills~     normal and cancerous lymphocytes, including T cells. Although Campath-1H is an experimental~     drug for treating ATL, it is approved by the Food and Drug Administration for treating~     chronic lymphocytic leukemia.~      Patients 18 years of age and older with any type of ATL except smoldering may be eligible for~     this study. Candidates are screened with a medical history and physical examination, photos~     of skin lesions, measurement of lesions such as lymph nodes and skin nodules, blood and urine~     tests, electrocardiogram (EKG), chest x-ray, computed tomography (CT) scan or ultrasound of~     the abdomen, skin biopsy, bone marrow aspirate and biopsy, skin test, and lumbar puncture~     (spinal tap). Participants undergo treatment in two phases, as follows:~        -  Dose escalation phase: Patients receive an infusion of Campath-1H daily for three days.~          The initial dose is low and is increased daily as long as there are no side effects, or~          only mild reactions, until the patient is receiving the maximum dose of 30 milligrams~          per day.~        -  Stable dose phase: Patients receive infusions of Campath-1H 30 mg three times a week for~          up to 12 weeks.~      In addition to treatment, patients are evaluated with the following tests and procedures:~        -  History and physical examination every 4 weeks.~        -  Blood tests every 4 weeks.~        -  CT scans to measure the size of the tumors every 4 weeks.~        -  Skin biopsies (if skin disease is present) and lymph note aspirates: Up to five biopsies~          and five aspirates may be taken to help diagnose the disease and evaluate the effect of~          Campath-1H on the cancer.~        -  Bone marrow biopsy: This procedure may be done to document or monitor disease progress.~      Patients receive treatment for up to 12 weeks. Treatment may stop earlier if the patient~     achieves a complete response before the end of 12 weeks. Patients completing the study are~     followed periodically with a history and physical examination, blood and urine tests, tumor~     evaluation, skin biopsy and skin testing. They are seen monthly at first and then at 3-month~     intervals the first year; every 4 months the second year, every 6 months for the third~     through fifth years, and then yearly.~   "
267923|NCT00061022|"~     This study will determine if NXY-059 will improve recovery from an acute stroke. The study is~     designed to look at both overall recovery and recovery of motor function, for example muscle~     strengthen and coordination.~   "
267924|NCT00006046|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have advanced colorectal cancer.~   "
267925|NCT00005999|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have stage IVB or recurrent cervical cancer.~   "
267926|NCT00005977|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.~   "
267927|NCT00005971|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who~     have metastatic malignant melanoma.~   "
267928|NCT00005956|"~     RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an~     immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients~     who have advanced cancer that shows no signs of disease following treatment.~   "
267929|NCT00005868|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating~     patients who have untreated stage IIIA non-small cell lung cancer.~   "
267930|NCT00061009|"~     This study will investigate the relationship between susceptibility to hypnosis and~     regulation of the autonomic nervous system (nerves that control involuntary body functions,~     such as heart rate and sweating).~      Hypnosis is a state of mind in which the individual is highly focused, relatively unaware of~     his or her surroundings, and possibly more able to accept and use therapeutic suggestions.~     People vary in their responsiveness, or susceptibility, while in hypnosis. People with~     certain conditions, such as chronic fatigue syndrome (CFS), chronic pain, posttraumatic~     stress disorder (PTSD), and generalized anxiety disorder (GAD) have altered hypnotic~     susceptibility. Patients with chronic orthostatic intolerance (COI) often have symptoms~     similar to those of individuals with CFS, chronic pain, PTSD, and GAD, and this study will~     examine how patients with COI respond to hypnosis as compared with healthy normal volunteers.~     COI is a group of disorders characterized by intolerance to prolonged standing. Among them~     are neurocardiogenic syncope (NCS), in which patients have recurrent episodes of sudden loss~     of consciousness, and postural tachycardia syndrome (POTS), in which patients have a~     sustained increase in heart rate after standing.~      In addition to the comparison of COI and normal volunteer responses to hypnosis, the study~     will examine how hypnotic susceptibility is related to the ability to control autonomic~     functions such as blood pressure, heart rate, and sweating. The autonomic nervous system is~     activated when the body is stressed, not only from physical stimuli such as cold temperature,~     but also from mental stimuli, such as seeing a rattlesnake up close. Hypnosis may, therefore,~     be a useful tool to understand how the mind controls the autonomic nervous system.~      Healthy normal volunteers and patients with NCS or POTS who are 18 years of age or older may~     be eligible for this two-part study. In part 1, participants complete a questionnaire and are~     then tested for hypnotic susceptibility. For this test, a professionally trained physician~     guides the subject through a procedure to achieve a hypnotic state. The subject is asked to~     perform several simple tasks and is then guided back to a normal state of being. In part 2,~     the subject undergoes hypnosis again, during which the physician offers various suggestions~     while monitoring activity of the subject's autonomic nervous system. The subject is connected~     to various sensors that continuously monitor blood pressure, heart rate, blood flow, sweat~     response, skin electrical conduction, and brain wave activity. An intravenous catheter is~     inserted into an arm vein to collect blood samples. At the end, the subject is guided back to~     a normal state of being.~      The hypnosis session in part 1 is videotaped in order to: 1) permit review by a scientist who~     is unaware of the subject's condition and whose judgment will not, therefore, be biased; and~     2) have a record of the experimental data. Only qualified investigators will view the~     videotape.~   "
267931|NCT00060996|"~     The purpose of this study is to assess and compare the safety of continuous and daily~     subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned~     vascular interventional procedures; and to determine the effect of Remodulin on wound healing~     and treadmill walk distance.~   "
267932|NCT00005813|"~     RATIONALE: Bispecific antibodies plus white blood cells may be able to locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of combining bispecific antibodies with~     white blood cells in treating patients who have recurrent or refractory glioblastoma~     multiforme.~   "
267933|NCT00060983|"~     This study is part of a larger clinical trial that examines the potential of a 12-week~     treadmill-training program to improve walking in patients with spinal cord injuries (SCIs).~     Patients in the trial are at least 1 year past their injury. This substudy tests a~     combination of two strategies to enhance the treadmill training program: electrically~     stimulating a muscle withdrawal reflex and providing body weight support by partially~     suspending patients as they walk on the treadmill.~   "
267934|NCT00060970|"~     Patients who are forced to rest or reduce activity as a result of illness, injury, or surgery~     often experience resulting muscle weakness. This study will evaluate muscle features and~     muscle strength in patients who are recovering from surgery for broken ankles. The goal of~     this study is to improve the recovery of muscle function and overall ability after prolonged~     periods of ankle inactivity due to surgery.~   "
267935|NCT00060957|"~     This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and~     spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally~     occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.~   "
267936|NCT00060944|"~     The purpose of this study is to test the safety and effectiveness of an investigational~     chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or~     leiomyosarcoma.~   "
267937|NCT00005861|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating women~     who have recurrent, stage III, or stage IV endometrial cancer.~   "
267938|NCT00005588|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known which regimen of radiation therapy is more effective following surgery for breast~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of~     radiation therapy following surgery in treating women who have early stage breast cancer.~   "
267939|NCT00005587|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known which regimen of radiation therapy is more effective following surgery for breast~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of radiation~     therapy following surgery in treating women who have early stage breast cancer.~   "
267940|NCT00003203|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Combining carboplatin and vincristine with~     radiation therapy followed by adjuvant chemotherapy may kill more tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy~     plus radiation therapy followed adjuvant chemotherapy in treating young patients who have~     newly diagnosed high-risk CNS embryonal tumors.~   "
267941|NCT00060931|"~     Evaluation of the effect of two different antihypertensive treatments on control of glucose~     in Type II diabetic patients with high blood pressure~   "
267942|NCT00060918|"~     To evaluate the effects of two different antihypertensive medications in the drug class of~     beta-blockers on control of glucose in Type II diabetic patients with high blood pressure.~   "
267943|NCT00060905|"~     The purpose of this study is to determine the safety and effectiveness of Depakote ER~     compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.~   "
267944|NCT00060892|"~     The primary purpose of this study was to assess the overall safety of different dose regimens~     of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood~     perfusion in subjects with critical limb ischemia (CLI). This study also evaluated the~     improvement in wound healing without adverse effects on the quality of life, as well as the~     potential reduction of amputation, mortality and rest pain in the CLI population.~   "
267945|NCT00005086|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have stage IV locally advanced or metastatic bladder cancer.~   "
267946|NCT00005078|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining tirapazamine, carboplatin, and~     paclitaxel in treating patients who have advanced malignant solid tumors.~   "
267947|NCT00060866|"~     This study will examine the effectiveness of the drug propranolol in preventing fainting in~     patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system~     and chemical responses in which the blood vessels in skeletal muscles do not remain~     constricted appropriately during standing for a long time. This can lower blood pressure and~     cause fainting. Propranolol Inderal (registered trademark) is a Food and Drug~     Administration-approved drug that belongs to a class of drugs called beta-blockers. These~     drugs slow the heart rate and maintain blood pressure in certain situations.~      Patients 18 years of age and older with SAI may be eligible for this study. Screening~     includes a tilt table test, described below, to determine if the patient has a particular~     chemical pattern in the blood.~      Patients enrolled in the study take propranolol pills in increasing doses during the first~     week of the study to determine the proper dose for the individual. Then, the drug is stopped~     until the experimental phase of the study begins. In this phase, patients are randomly~     assigned to take either propranolol or placebo (look-alike pill with no active ingredient)~     for 4 days. On the fourth day, the patient undergoes a tilt table test to determine whether~     the treatment affects the patient's ability to tolerate tilt. For this test, the patient lies~     on a padded table with a motorized tilt mechanism that can move the patient from a flat~     position to an upright position in about 10 seconds. The patient remains upright for up to 45~     minutes while the following measurements are taken:~        -  Arterial blood pressure monitoring and arterial blood sampling. A catheter (thin,~          plastic tube) is inserted into an artery in the elbow crease area of the arm or the~          wrist. This catheter allows continuous blood pressure monitoring and sampling of~          arterial (oxygenated) blood during the tilt test.~        -  Venous blood sampling and measurement of epinephrine and norepinephrine release. A~          catheter is inserted into a vein in each arm, one to collect venous (deoxygenated) blood~          samples, and the other to inject radioactive epinephrine (adrenaline) and norepinephrine~          (noradrenaline). These radioactive drugs, or ,tracers, allow measurement of the rate of~          release of the body's own norepinephrine and epinephrine into the bloodstream.~        -  Physiologic measurements. Blood pressure, heart rate, and EKG are measured continuously~          during the tilt test session, and blood flows and skin electrical conduction are~          measured intermittently. Blood flow is measured using sensors applied to the skin and a~          blood pressure cuff around the limb. For skin blood flow measurements, a laser beam~          scans the skin surface. The skin electrical conduction test measures how well the skin~          conducts electricity. This is measured through sensors placed on the fingers or other~          sites.~      The effects of the test drug are allowed to wear off for 1 week, after which the entire tilt~     test procedure is repeated. Patients who were given propranolol for the first test session~     take placebo for the repeat session, and those who were given placebo take propranolol.~   "
267973|NCT00060567|"~     E7070 and irinotecan will be administered to patients with GI tract, pancreatic or lung~     tumors on Days 1 and 8 of a 21-day cycle, or Days 1 and 15 of a 28-day cycle according to one~     of two E7070 dose escalation schemes.~   "
267948|NCT00060840|"~     The purpose of this study is to assess the utility of nitric oxide for inhalation during left~     ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is~     to be assessed by the number of patients in each treatment group meeting failure criteria~     within 24 hours on study drug, as defined by two or more of the following:~        -  Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2~        -  Administration of ≥ 20 inotropic equivalents (IE)~             -  10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE~             -  0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE~             -  1 µg/kg/min milrinone is equivalent to 15 IE~             -  0.1 U/min vasopressin is equivalent to 10 IE~        -  Mean arterial pressure (MAP) ≤ 55 mmHg~        -  Central venous pressure (CVP) ≥ 16 mmHg~        -  Percent mixed venous oxygen saturation (SvO2) ≤ 55%~      Or at least one of the following criteria:~        -  Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure.~          Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues~          will not be considere 'failure to wean'~        -  Death~   "
267949|NCT00060827|"~     Head impacts in sports can lead to brain injury even when the participant is wearing a~     helmet. The forces that contribute to brain injury from sports-related head impacts are not~     well understood. This study will test a new device to measure the speed of head impacts among~     football players.~   "
267950|NCT00060814|"~     The purpose of this pilot study is to examine the effects of combined pharmacotherapy~     (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy~     patients.~   "
267951|NCT00060853|"~     This study will use magnetic resonance imaging (MRI) to identify brain regions involved in~     social and emotional reasoning. It will identify differences in brain activity during task~     performance between people who have a nervous system illness and those who do not. MRI is a~     diagnostic tool that uses a strong magnetic field and radio waves to produce images of~     structural and chemical changes in the brain.~      Healthy normal volunteers between 21 and 55 years of age who are right-handed and are native~     English speakers may be eligible for this study. Candidates will be screened with a medical~     history, including psychiatric and neurological information.~      Participants will be asked to perform social and emotional reasoning tasks, such as sorting~     and judging rules and rule violations, while undergoing MRI scanning. Some tasks may simply~     involve viewing items on a screen. Others may involve solving complex problems and responding~     by pressing buttons. During the scan, the subject lies on a table in a narrow cylinder (the~     scanner) containing a magnetic field. The scan will last about 2 hours, with subjects asked~     to lie still for up to 10 minutes at a time.~   "
267952|NCT00060801|"~     The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284~     BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in~     adult and pediatric cystic fibrosis patients.~   "
267953|NCT00060788|"~     Antisocial behavior often occurs in different generations within the same family. However, it~     is not known what factors contribute to this passing of antisocial behavior from parent to~     child to grandchild. This study is part of a project evaluating antisocial behavior in~     families; it focuses on the passage of such behavior from one generation to the next.~   "
267954|NCT00004931|"~     Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with~     or without oxaliplatin in treating patients who have stage II or stage III colon cancer.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug may kill more tumor cells. It is not yet known~     which combination chemotherapy regimen is more effective for colon cancer~   "
267955|NCT00004928|"~     RATIONALE: Calcitriol may help prostate cancer cells develop into normal cells. Zoledronate~     may delay or prevent the formation of bone metastases. Combining calcitriol and zoledronate~     may be an effective treatment for progressive prostate cancer.~      PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with zoledronate in~     treating patients who have progressive prostate cancer.~   "
267956|NCT00004925|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells.~      PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab~     in treating women who have locally advanced, inflammatory, or metastatic breast cancer.~   "
267957|NCT00004916|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of ifosfamide, teniposide, and~     paclitaxel in treating patients who have relapsed non-Hodgkin's lymphoma.~   "
267958|NCT00004911|"~     RATIONALE: The use of endoscopy to place a metal stent in the large intestine is less~     invasive than surgery for treating cancer-related bowel obstruction and may have fewer side~     effects and improve recovery.~      PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of a metal stent~     in treating patients who have cancer-related bowel obstruction.~   "
267959|NCT00060775|"~     The purpose of this study is to use brain imaging technology to examine brain changes that~     occur in children when they are exposed to various kinds of emotional tasks and to determine~     if these changes are related to the child's temperament.~      Studies suggest that the risk for developing mood and anxiety disorders in preschool children~     may be linked to differences in temperament. The relationship between temperament and risk or~     resilience may reflect the influences of brain activity on behavior at different stages of~     childhood development. Behavioral inhibition and mood or anxiety disorders have been linked~     to disturbances in the circuitry of several areas in the brain. However, the involvement of~     this circuitry in temperament remains unclear. This study will use functional magnetic~     resonance imaging (fMRI) to examine the function of different parts of the brain in children~     who have previously undergone temperament studies and have had their temperaments classified.~      Two sets of studies will be performed in the current protocol. A small set of pilot studies~     will be performed in infants, by staff at the University of Maryland. In terms of the studies~     among infants, these subjects will initially be contacted by staff at Maryland and then will~     be seen at the NIH for up to three visits lasting between 4- to 5- hours during the first~     year of life. These subjects also will undergo visits at the University of Maryland~     throughout the first year of life.~      This study will comprise up to four clinic visits. At Visit 1, children and their parents~     will meet with study staff individually and together for psychiatric interviews. Children~     will undergo a physical examination, medical history, a urine drug test, and practice in an~     fMRI simulator. Saliva samples will be collected from the children and tests will be given to~     assess stage of puberty, temperament, intelligence, feelings, experiences, and behavior.~     Other visits include fMRI scans of the brain and other tasks.~   "
267960|NCT00060762|"~     This study will evaluate the long-term effectiveness of interpersonal psychotherapy,~     behavioral weight loss interventions, and guided self help treatments in treating binge~     eating disorder (BED).~   "
267961|NCT00060723|"~     Sleep-disordered breathing (SDB) in children may be responsible for disruptive daytime~     behaviors such as inattention and hyperactivity. Many children undergo tonsillectomy for SDB~     and disruptive daytime behaviors. However, the link between SDB and disruptive behavior is~     not clearly understood. This study will evaluate the relationship between SDB and disruptive~     behavior.~   "
267962|NCT00060710|"~     The purpose of this study is to determine the efficacy of CP-461 given twice daily orally in~     patients with advanced or metastatic malignant melanoma and to evaluate the safety profile of~     CP-461 in this patient population.~   "
267963|NCT00060749|"~     This study will evaluate whether docosahexaenoic acid (DHA) dietary supplementation can~     improve macular function in patients with Stargardt macular dystrophy and Stargardt-like~     macular dystrophy. Stargardt macular dystrophy is a recessive inherited trait that causes a~     severe form of macular degeneration. (The macula is the center part of the retina in the back~     of the eye that is responsible for fine vision.) The disorder begins in late childhood and~     progresses to a significant decrease in central vision. One of the earliest signs of the~     disorder is accumulation in and under the macula of a fatty pigment called lipofuscin.~     Stargardt-like macular dystrophy is a dominant inherited trait involving loss of central~     vision, but it begins later than Stargardt macular dystrophy, and the accumulation of~     lipofuscin extends beyond the central region of the macula. DHA is a fatty acid that is~     essential for normal brain and eye development. It is normally found in the diet, but not in~     large amounts. Supplements may help prevent or slow the progression of some eye diseases.~      Patients with autosomal dominant Stargardt-like macular dystrophy or autosomal recessive~     Stargardt macular dystrophy are eligible for this study. Candidates will be screened with the~     following tests and procedures:~        -  Medical history and physical examination.~        -  Blood test to measure levels of DHA and vitamins.~        -  Eye examination: The patient's vision and eye pressure are tested, then the pupils are~          dilated to examine structures inside the eye. Photographs are also taken.~        -  Visual field test: The patient looks at a tiny spot of light projected onto a white~          screen and is asked to note when other lights appear at other places on the screen.~        -  Electroretinogram (ERG): An electrode (small silver disk) is taped to the patient's~          forehead. Drops are given to numb the eyes and special contact lenses are inserted in~          the eyes. For the first part of the test, the patient looks at the center of a black and~          white checkerboard screen that flickers for 30 seconds at a time. This is repeated 16 or~          more times. For the second part of the test, the patient looks inside a sphere, in which~          flashes of light flicker for 20 seconds at a time. This is repeated four or more times.~          The contact lenses sense small electrical signals generated by the retina during the~          tests.~      Participants will begin taking DHA capsules or a placebo (look-alike capsules with no active~     ingredient) from 1 week to 3 months after enrolling in the study and will repeat several of~     the screening tests at follow-up visits scheduled 3, 6, 9, 12, and 15 months after they start~     taking the capsules. They will also be interviewed about any treatment side effects.~   "
267964|NCT00060736|"~     This study evaluates the effects on mood when stopping estrogen replacement therapy.~      The purpose of this study is to investigate the effects of estrogen levels on perimenopausal~     depression. This study will examine short-term withdrawal of estrogen in women whose mood had~     improved with estrogen therapy.~      Perimenopause-related mood disorders cause significant distress in a large number of women.~     Evidence suggests that estradiol may have beneficial effects in women with perimenopausal~     depression. However, the effect of declining estradiol secretion during perimenopause has not~     been fully examined.~      Peri- and post-menopausal women who experience a remission of perimenopause-related~     depression symptoms while on estrogen therapy and a control group of healthy volunteers on~     hormone replacement therapy (HRT) will be switched from their current form of HRT to~     estradiol for a 3-week period; volunteers will also complete symptom ratings to confirm the~     absence of mood symptoms. Participants will then be randomly assigned to either continue~     estradiol or take a placebo (an inactive pill) for an additional 3 weeks. Mood ratings will~     be used to determine response to estradiol withdrawal.~   "
267965|NCT00060697|"~     The goal of this study is to enhance the mother's role in promoting avoidance of sexual risks~     and problem behaviors in 6- to 12-year-old children. Consenting mothers will attend a~     10-session program designed to enhance the quality of mother-child communication, identify~     sexual risks, and increase parental monitoring and self-efficacy.~   "
267966|NCT00060684|"~     The aim of this trial is to determine the appropriate dose of pixantrone to be used in this~     combination and obtain data on the combination's safety and activity profile.~   "
267967|NCT00060671|"~     The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name~     pending) with the monoclonal antibody rituximab, leads to an increase in the period of~     patients' remission, compared to rituximab alone.~   "
267968|NCT00060645|"~     Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of~     AP23573 in patients with refractory or recurrent malignancies, including myeloma and~     lymphoma.~   "
267969|NCT00060632|"~     Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of~     ridaforolimus in patients with refractory or recurrent malignancies, including myeloma and~     lymphoma.~   "
267970|NCT00060619|"~     This study will evaluate a new model for assessing and treating migraine and recurrent~     abdominal pain in children. The model combines behavioral techniques such as relaxation~     training with biologic components such as thermal biofeedback.~   "
267971|NCT00060658|"~     This study will use magnetic resonance imaging (MRI) to identify brain regions involved in~     solving algebraic math problems. It will examine brain activation according to the level of~     difficulty and the number of steps required to solve the problem. This information will help~     identify a possible correlation between problem-solving strategies and patterns of brain~     activation.~      Undergraduate or graduate students between 19 and 36 years of age who have completed at least~     2 years of college, have had at least one college course in integral calculus, and who have~     no history of neurological disease may be eligible for this study. Candidates will be~     screened with a medical history, including psychiatric and neurological information.~      Participants will be asked to mentally solve a variety of integral calculus problems while~     undergoing MRI scanning, a procedure that uses a strong magnetic field and radio waves to~     produce images of structural and chemical changes in the brain. During the scan, the subject~     lies on a table in a narrow cylinder (the scanner) containing a magnetic field. A problem and~     possible solution are presented to the subject, who presses a button to verify if the answer~     is correct. At the end of the test, the participant completes a follow-up questionnaire to~     determine the problem-solving strategies used.~   "
267972|NCT00060606|"~     Spina bifida (myelomeningocele) is a complex birth defect in which a portion of the spinal~     cord is not fully developed. The overlying bones and skin are incompletely formed and the~     underdeveloped area of the spinal cord is exposed on the surface of the back. Spina bifida~     defects are closed soon after birth to prevent further damage to the spinal cord and nerves.~     The Management of Myelomeningocele Study (MOMS) is a research study comparing two approaches~     to the treatment of babies with spina bifida: surgery before birth (prenatal surgery) and the~     standard closure, surgery after birth (postnatal surgery).~   "
267974|NCT00004910|"~     RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than~     surgery for treating cancer-related duodenal obstruction and may have fewer side effects and~     improve recovery.~      PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents~     in treating patients who have cancer-related obstruction of the duodenum.~   "
267975|NCT00004895|"~     RATIONALE: Palliative therapy with octreotide may help patients who have bowel obstruction~     that cannot be removed by surgery to live longer and more comfortably.~      PURPOSE: Phase II trial to study the effectiveness of octreotide as palliative therapy in~     treating patients who have cancer-related bowel obstruction that cannot be removed by~     surgery.~   "
267976|NCT00004255|"~     RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce~     the chance of developing graft-versus-host disease following bone marrow transplantation.~      PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow~     with that of untreated bone marrow in preventing graft-versus-host disease in patients with~     acute or chronic leukemia who are undergoing bone marrow transplantation.~   "
267977|NCT00004232|"~     RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune~     cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell~     transplantation in treating patients who have hematologic cancer.~   "
267978|NCT00004180|"~     RATIONALE: Rosiglitazone may help liposarcoma cells develop into normal fat cells.~      PURPOSE: Phase II trial to study the effectiveness of rosiglitazone in treating patients who~     have liposarcoma.~   "
267979|NCT00060593|"~     This study will use functional magnetic resonance imaging (MRI) to examine loss of balance in~     the elderly. Falls due to balance problems are a major health issue in older people, often~     resulting in bone fractures and other bodily injuries, and in functional decline. Risk~     factors for falling in the elderly include some standing positions in which older people~     usually experience balance problems, such as leaning forwards or backwards. Functional MRI~     records brain function while the subject performs a task, such as moving a limb or speaking,~     and detects changes in the brain regions involved in those tasks. This study will look at~     different brain areas to see which areas might control what people see around them while they~     are standing.~      Healthy normal volunteers between 20 and 90 years of age may be eligible for this study.~     Candidates must be in good health, have no difficulties in performing activities of daily~     living, and be able to walk for at least 400 meters (1/4 mile). They will be screened with a~     medical history and physical examination.~      Participants will undergo functional MRI while performing visual recognition tasks in two~     experiments, described below. For the MRI procedure, the subject lies in the MRI scanner, a~     narrow metal cylinder containing a strong magnet, for 20 minutes to 3 hours, with most scans~     lasting between 45 and 90 minutes. The experiments are as follows:~      Experiment 1~      During MRI scanning, the subject watches computer-generated movies of a person leaning~     forwards and backwards. When the subject recognizes an unstable body position in the~     movements, he or she presses a computer mouse.~      Experiment 2~      During MRI scanning, the subject watches still pictures of people leaning in stable and~     unstable postures and presses a button as soon as he or she recognizes that the posture is~     unstable.~   "
267980|NCT00060580|"~     This study will evaluate the ease and reliability of Raman scattering spectroscopy, a new~     technique to measure the amount of the pigment lutein in the retina, the light-sensitive~     tissue lining the back of the eye. The highest concentrations of lutein are in the center of~     the retina, called the macula, which is the area most important for fine, detailed vision.~     The functions of lutein are not fully known. Besides absorbing blue light, it may help~     protect against abnormal changes in the retina, such as age-related macular degeneration.~     Until recently, lutein was measured using long, cumbersome, and difficult tests. This study~     will evaluate a new instrument that provides faster measurements. It will be tested under~     different conditions, such as wearing or not wearing glasses or contact lenses, or dilating~     or not dilating the pupil of the eye.~      Healthy normal volunteers between 20 and 65 years of age may be eligible for this study,~     which involves two visits to the NIH Clinical Center, as follows:~      Visit 1 - Screening~        -  Medical history and physical examination, including measurement of vital signs (blood~          pressure, pulse, temperature, and breathing rate), and examination of the head and neck,~          heart and lungs, and arms and legs.~        -  Eye examination, including eye chart test, eye pressure measurement, examination of~          pupils and eye movements, and examination of the retina (back part of the eye) using a~          strong light and magnifying lens after dilation of the pupils.~        -  Raman scattering spectroscopy to measure lutein. For this test, the subject looks with~          one eye at a brief, bright flash of bluish light (similar to a flashbulb light) from a~          laser. This is repeated several times. Subjects who wear glasses or contact lenses for~          distance vision will be tested without them and then again with a lens in front of the~          eye. Subjects who do not wear glasses or contact lenses will be tested before and after~          dilation of the pupil.~        -  Contrast sensitivity to assess ability to identify an object from the background and to~          see everyday objects. The subject looks at and identifies a variety of objects of~          different shapes and sizes.~        -  Color vision to determine the ability to identify different shades of color. The subject~          arranges a line of colorful discs, similar to checkers, in order of similar shades.~      Visit 2 - Repeat Spectroscopy~      Subjects return 1 week after the screening visit for a repeat Raman scattering spectroscopy~     to evaluate the precision of the measurements.~   "
267981|NCT00060554|"~     The purpose of this research study is to obtain experience in the use of fondaparinux~     (Arixtra) as compared to heparin when administered to patients who undergo percutaneous~     coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a~     coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and~     heparin are drugs that inhibit blood clotting.~   "
267982|NCT00060515|"~     The objective of the study is to determine the safety and tolerability of RG2133 in patients~     with Mitochondrial Disease.~   "
267983|NCT00060502|"~     The purpose of this study is to evaluate the effectiveness and safety of infliximab, the~     active ingredient in Remicade, for the treatment of cachexia in pancreatic cancer patients~     who are receiving chemotherapy with gemcitabine.~   "
267984|NCT00060489|"~     The purpose of this study is to evaluate the efficacy and safety of quetiapine in the~     treatment of a major depressive episode in patients with bipolar disorder.~   "
267985|NCT00004094|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have previously untreated advanced cancer of the mouth,~     pharynx, or larynx.~   "
267986|NCT00004068|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation~     therapy and temozolomide in treating children who have newly diagnosed brain tumor.~   "
267987|NCT00004059|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. UCN-01 may increase the effectiveness of a chemotherapy drug by~     making tumor cells more sensitive to the drug.~      PURPOSE: Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating~     patients who have advanced or refractory solid tumors.~   "
267988|NCT00004052|"~     RATIONALE: Vaccines may make the body build an immune response to kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients~     who have chronic myelogenous leukemia.~   "
267989|NCT00004008|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who~     have ovarian epithelial cancer that has not responded to previous chemotherapy.~   "
267990|NCT00060541|"~     This study offers evaluation and treatment of patients with a variety of neurological~     disorders that may require surgery. The protocol is not designed to test new treatments;~     rather, patients will receive standard care. The study is designed to: 1) allow NINDS s~     Surgical Neurology Branch staff to learn more about changes that cause nervous system~     disorders, 2) train physicians in the evaluation and treatment of these disorders; and 3)~     establish a pool of patients who may be eligible for other NINDS protocols. (Participants in~     this protocol will not be required to join another study; the decision will be voluntary.)~      Patients of all ages with a disorder of the central nervous system (brain and spinal cord) or~     pituitary gland that may require surgery for diagnosis or treatment may be eligible for this~     study. In some cases surgery will not be needed. Candidates will be screened with a medical~     history and physical examination.~      Participants may undergo tests, medial treatment, or surgical treatment to help diagnose or~     treat their condition. In most cases, care provided at the NIH will be limited to evaluation~     and surgery. Procedures may include laboratory tests, imaging tests, such as magnetic~     resonance imaging (MRI), computed tomography (CT) scans, angiograms, and other procedures to~     confirm the patient s diagnosis or help guide treatment. Patients who require surgery will be~     offered standard surgical care at NIH. Those whose procedure includes removal of tissues or~     fluids for diagnostic studies will be asked to allow a portion of the tissue to be used for~     research purposes, including analysis for gene and protein abnormalities that may be involved~     in causing the disorder or in influencing the patient s response to treatment. Blood samples~     will also be drawn for research.~   "
267991|NCT00060528|"~     Background:~       Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and~     follows lung cancer as the leading cause of cancer death.~       Vaccine strategies represent a novel therapeutic approach in the treatment for prostate~     cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen~     (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial~     cells.~      Objectives:~       The primary objective is to determine the impact of granulocyte-macrophage colony~     stimulating factor (GM-CSF) and recombinant fowlpox granulocyte-macrophage colony stimulating~     factor (rF-GM-CSF) on the immunologic response in patients treated with these vaccines.~       Secondary - to determine the change in prostatic specific antigen (PSA)-specific T cells in~     patients treated with these vaccines using enzyme linked immunosorbent spot (ELISPOT) assay~     analysis.~       To document any objective anti-tumor responses that may occur.~      Eligibility:~       Patients must have androgen insensitive metastatic prostate cancer.~       All patients will have received and progressed on hormonal therapy.~       Must have objective evidence of metastasis or relapsing local disease. Therefore, must have~     a rising PSA and at least one of the following: positive bone scan, palpable disease, or~     positive imaging studies.~       Must have a life expectancy of more than 6 months and Eastern Cooperative Oncology Group~     (ECOG) status of 0 to 2.~      Patients must be human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+).~       Granulocyte count greater than or equal to 1,500/mm^3, Platelet greater than or equal to~     100,000/mm^3, hemoglobin (Hgb) greater than or equal to 10Gm/dL, Lymphocyte count greater~     than or equal to 500/mm^3 ;Bilirubin less than 1.5mg/dL, aspartate aminotransferase (AST) and~     alanine aminotransferase (ALT) less than 2.5x upper limit of normal (ULN),Creatinine~     Clearance greater than or equal to 60~       No significant cardiac disease, no significant pulmonary disease, no serious inter-current~     medical illness.~      Design:~       Cohorts three, four and five will provide safety data combining cohort two with rGM-CSF as~     well as two doses of rFGM-CSF respectively.~      This study will be conducted as a small, randomized pilot study to compare the immunologic~     effects of the above vaccine strategy alone, with recombinant granulocyte-macrophage colony~     stimulating factor (GM-CSF), or with either of 2 doses of fowlpox-GM-CSF.~      This study will consist of 4 randomized arms of 8 patients each, all of whom are HLA-A2+.~      The maximum accrual to the trial should be 62.~   "
267992|NCT00060476|"~     To determine the efficacy and safety of an investigational compound (MK0966) for the~     prevention of prostate cancer.~   "
267993|NCT00060463|"~     This study will evaluate the effect of easy access to emergency contraceptive pills (ECPs) on~     the rates of pregnancy and sexually transmitted infections (STIs).~   "
267994|NCT00060450|"~     The purpose of this study is to evaluate the effects of inhaled nitric oxide on both~     short-term physiology as well as on the development of ischemia-reperfusion lung injury~     (IRLI) in the immediate post transplant period. The specific hypothesis is that inhaled NO~     post lung transplantation will improve gas exchange/hemodynamic and thus reduce the~     development of post transplant IRLI.~   "
267995|NCT00060437|"~     RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who~     have prostate cancer that no longer responds to androgen ablation therapy.~   "
267996|NCT00060424|"~     This clinical trial studies how well giving fludarabine phosphate together with total-body~     irradiation (TBI) before donor peripheral blood stem cell transplant works in treating~     patients with chronic lymphocytic leukemia or small lymphocytic leukemia. Giving low doses of~     chemotherapy, such as fludarabine phosphate, and TBI before a donor peripheral blood stem~     cell transplant helps stop the growth of cancer cells. Giving chemotherapy before or after~     peripheral blood stem cell transplant also stops the patient's immune system from rejecting~     the donor's stem cells. The donated stem cells may replace the patient's immune cells and~     help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving cyclosporine and mycophenolate mofetil before and after the transplant may stop~     this from happening.~   "
267997|NCT00060411|"~     Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.~     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help~     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of~     colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy work in~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     erlotinib and bevacizumab with combination chemotherapy may kill more tumor cells. This phase~     I trial is studying the side effects and best dose of erlotinib when given together with~     bevacizumab, fluorouracil, leucovorin, and oxaliplatin in treating patients with metastatic~     or locally advanced colorectal cancer.~   "
267998|NCT00060398|"~     RATIONALE: Epoetin alfa may stimulate red blood cell production and may help improve~     cancer-related anemia and fatigue. Steroid therapy with dexamethasone may increase the~     effectiveness of epoetin alfa. It is not yet known if epoetin alfa is more effective with or~     without dexamethasone in treating anemia-related fatigue in patients with prostate cancer.~      PURPOSE: This randomized phase III trial is studying epoetin alfa and dexamethasone to see~     how well they work compared to epoetin alfa alone in treating anemia-related fatigue in~     patients with prostate cancer that is refractory to treatment with hormone therapy.~   "
267999|NCT00060385|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which combination chemotherapy regimen is more effective in treating~     non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase II/III trial to compare the effectiveness of combination~     chemotherapy with or without etoposide in treating older patients who have non-Hodgkin's~     lymphoma that has not been previously treated.~   "
268000|NCT00060372|"~     This phase I trial is studying how well ipilimumab works after allogeneic stem cell~     transplant in treating patients with persistent or progressive cancer. Monoclonal antibodies~     can locate cancer cells and either kill them or deliver cancer-killing substances to them~     without harming normal cells.~   "
268001|NCT00060359|"~     This phase I trial is studying the side effects and best dose of polyglutamate paclitaxel~     when given together with carboplatin in treating patients with ovarian epithelial,~     peritoneal, or fallopian tube cancer. Drugs used in chemotherapy such as polyglutamate~     paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop~     growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor~     cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with~     carboplatin may kill more tumor cells.~   "
268002|NCT00060346|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy work in different ways to stop cancer cells from dividing so they stop growing~     or die. Combining rituximab with combination chemotherapy may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with combination~     chemotherapy works in treating patients with newly diagnosed Waldenstrom's macroglobulinemia.~   "
268003|NCT00060333|"~     This phase II trial is studying how well adjuvant radiation therapy works in treating~     patients who have undergone surgery for desmoplastic melanoma. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery may kill any~     tumor cells remaining after surgery.~   "
268004|NCT00060320|"~     RATIONALE: The herbal supplement black cohosh may be effective in relieving hot flashes in~     women.~      PURPOSE: Randomized phase III trial to determine the effectiveness of black cohosh in~     relieving hot flashes in women who have breast cancer or who are at risk of developing breast~     cancer.~   "
268005|NCT00060307|"~     This phase II trial is studying how well erlotinib works in treating patients with locally~     advanced or metastatic papillary renal cell (kidney) cancer. Erlotinib may stop the growth of~     tumor cells by blocking the enzymes necessary for tumor cell growth~   "
268006|NCT00060294|"~     RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can~     locate cancer cells and either kill them or deliver radioactive cancer-killing substances to~     them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan in~     treating patients who have Waldenstrom's macroglobulinemia.~   "
268007|NCT00060268|"~     RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to~     light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells~     and, when exposed to light, become active and kill the tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in~     treating patients who have obstructive esophageal tumors.~   "
268008|NCT00060255|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining chemotherapy with autologous stem cell transplantation or autologous bone~     marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and~     kill more cancer cells.~      PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy~     regimens with or without total-body irradiation followed by autologous stem cell~     transplantation or autologous bone marrow transplantation works in treating patients with~     hematologic malignancies or solid tumors.~   "
268009|NCT00060242|"~     RATIONALE: Combretastatin A4 phosphate may stop the growth of anaplastic thyroid cancer by~     stopping blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well combretastatin A4 phosphate works in~     treating patients with advanced recurrent or metastatic anaplastic thyroid cancer.~   "
268010|NCT00060203|"~     RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer~     cells from dividing so they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who~     have recurrent or refractory multiple myeloma.~   "
268011|NCT00060151|"~     RATIONALE: GW786034 may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth and by stopping blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of GW786034 in~     treating patients with advanced solid tumors.~   "
268012|NCT00060138|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone~     loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal~     antibody is more effective than zoledronate in treating women who have breast cancer and bone~     metastases.~      PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody with~     that of zoledronate in treating women who have breast cancer and bone metastases.~   "
268013|NCT00060125|"~     This phase II trial is studying how well tipifarnib works in treating patients with~     metastatic malignant melanoma. Tipifarnib may stop the growth of tumor cells by blocking the~     enzymes necessary for tumor cell growth.~   "
268014|NCT00060112|"~     Drugs used in chemotherapy such as gemcitabine use different ways to stop cancer cells from~     dividing so they stop growing or die. Oblimersen may increase the effectiveness of~     gemcitabine by making cancer cells more sensitive to the drug. This phase I trial is studying~     the side effects and best dose of oblimersen and gemcitabine in treating patients with~     metastatic or unresectable solid tumors or lymphoma~   "
268045|NCT00004127|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil~     and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus~     or stomach.~   "
268015|NCT00060099|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of or treat early cancer. SGN-00101 may be effective in preventing the~     development of cervical cancer in patients with cervical intraepithelial neoplasia.~      PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing~     cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.~   "
268016|NCT00060086|"~     RATIONALE: Pomegranate juice may contain substances that decrease or slow the rise of~     prostate-specific antigen (PSA) levels and may be effective in delaying or preventing~     recurrent prostate cancer.~      PURPOSE: This phase II trial is studying how well pomegranate juice works in decreasing or~     slowing the rise of PSA levels in patients who have undergone radiation therapy or surgery~     for prostate cancer.~   "
268017|NCT00060021|"~     RATIONALE: Acupuncture may be effective in relieving mucositis-related pain caused by~     chemotherapy in patients undergoing stem cell transplantation.~      PURPOSE: Randomized clinical trial to study the effectiveness of acupuncture in treating~     mucositis-related pain caused by high-dose chemotherapy in patients who are undergoing stem~     cell transplantation.~   "
268018|NCT00060008|"~     RATIONALE: New imaging procedures such as fludeoxyglucose F 18 positron emission tomography~     (FDG-PET) and magnetic resonance (MR) perfusion imaging may improve the ability to detect~     disease progression, help doctors predict a patient's response to treatment, and help plan~     the most effective treatment.~      PURPOSE: This diagnostic trial is studying how well FDG-PET and MR perfusion imaging work in~     finding disease progression and determining response to treatment in patients with~     neurofibromatosis 1 and plexiform neurofibroma.~   "
268019|NCT00059995|"~     RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them~     or deliver cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in~     treating patients who have refractory or relapsed lymphoma.~   "
268020|NCT00059982|"~     RATIONALE: Perifosine may stop the growth of tumor cells by blocking the enzymes necessary~     for tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who~     have locally advanced, unresectable, or metastatic pancreatic cancer.~   "
268021|NCT00059943|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients~     with metastatic breast, lung, or prostate cancer.~   "
268022|NCT00059930|"~     The purpose of this study is to find the highest dose that can be given safely to people who~     have had liver disease resected. This is a Phase I study. The goal of a phase I study is to~     find a safe dose range based on side effects. The drugs that will be given by vein are~     OXALIPLATIN (Oxali) plus 5-FLUOROURACIL and LEUCOVORIN (5FU and LV). This is systemic~     chemotherapy, since it goes to the whole body. The drugs that will be placed in the pump are~     FLOXURIDINE (FUDR) and DEXAMETHASONE. (The dexamethasone is not an anti-tumor drug; it helps~     protect healthy liver tissue from possible side effects of the FUDR.) This is the regional~     chemotherapy, since it goes only to the liver. The researchers have studied these drugs and~     know the best doses of each when they are used in patients who have not had liver resections.~     We do not yet know how the drugs work with each other in patients with a liver resection.~     This study will tell us the best doses of each drug when they are given over the same period~     of time.~   "
268023|NCT00059917|"~     RATIONALE: Drugs used in chemotherapy such as polyglutamate camptothecin may be able to~     deliver the drug directly to tumor cells while leaving normal cells undamaged.~      PURPOSE: Phase I trial to study the effectiveness of polyglutamate camptothecin in treating~     patients who have advanced cancer.~   "
268024|NCT00059904|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2~     may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with~     interleukin-2 may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2~     in treating patients who have relapsed or refractory intermediate- or high-grade~     non-Hodgkin's lymphoma.~   "
268025|NCT00059891|"~     RATIONALE: An anal sphincter prosthesis may replace the need for a permanent colostomy and~     may improve the quality of life of patients who are undergoing surgery for anal or rectal~     cancer.~      PURPOSE: Clinical trial to study the effectiveness of an anal sphincter prosthesis in~     treating patients who have anal or rectal cancer and are undergoing surgery to remove the~     anus and rectum.~   "
268026|NCT00059878|"~     RATIONALE: Antifungals such as voriconazole may be effective in controlling fungal~     infections. Combining voriconazole with interferon gamma may be more effective than~     voriconazole alone in treating fungal infections.~      PURPOSE: Randomized phase II trial to compare the effectiveness of voriconazole with or~     without interferon gamma in treating patients who have aspergillosis or other fungal~     infections.~   "
268027|NCT00059865|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop~     tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the~     growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining~     gemcitabine with pemetrexed disodium may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when~     given together with pemetrexed disodium to see how well it works in treating patients with~     unresectable or metastatic biliary tract or gallbladder cancer.~   "
268028|NCT00059852|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop~     tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor~     cells by blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with~     erlotinib may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with erlotinib in~     treating patients who have metastatic breast cancer that has been previously treated with an~     anthracycline and/or a taxane.~   "
268046|NCT00004095|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining irinotecan and gemcitabine in~     treating patients who have unresectable or metastatic solid tumors.~   "
268029|NCT00059839|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known if combination chemotherapy with vinblastine is more effective than combination~     chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination~     chemotherapy regimens with either vinblastine or vincristine in treating patients who have~     newly diagnosed advanced anaplastic large cell lymphoma.~   "
268030|NCT00059826|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may~     interfere with the growth of tumor cells. Radiation therapy uses high-energy radiation from~     x-rays and other sources to kill tumor cells. Combining chemotherapy with interferon alfa and~     giving them with radiation therapy after surgery may kill any remaining tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and~     interferon alfa in treating patients who have resected stage I, stage II, or stage III~     pancreatic cancer.~   "
268031|NCT00059813|"~     Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in~     treating patients who have metastatic renal cell (kidney) cancer. Interferon alfa may~     interfere with the growth of tumor cells. Oblimersen may increase the effectiveness of~     interferon alfa by making tumor cells more sensitive to the drug.~   "
268032|NCT00059800|"~     RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming~     normal tissue.~      PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in~     treating patients who have melanoma.~   "
268033|NCT00059787|"~     This phase II trial is studying the side effects of giving erlotinib together with~     carboplatin and paclitaxel and to see how well it works in treating patients with stage III~     or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Biological therapies such~     as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.~     Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop~     tumor cells from dividing so they stop growing or die.~   "
268034|NCT00059761|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effect on the body when combining irinotecan and~     cisplatin with radiation therapy in treating patients who have limited-stage small cell lung~     cancer that could not be completely removed during surgery.~   "
268035|NCT00059735|"~     The purpose of this study is to determine if E7070 is a safe and effective treatment for~     cancer of the kidneys.~   "
268036|NCT00043108|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Giving combination chemotherapy with radiation therapy before and after surgery may shrink~     the tumor so it can be removed during surgery and may kill any remaining tumor cells~     following surgery.~      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin~     with radiation therapy and surgery in treating patients who have newly diagnosed locally~     advanced non-small cell lung cancer.~   "
268037|NCT00030667|"~     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have~     relapsed or refractory solid tumors of childhood. Imatinib mesylate may stop the growth of~     tumor cells by blocking the enzymes necessary for their growth.~   "
268038|NCT00030524|"~     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells~     and slow the growth of colorectal cancer.~      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have~     locally advanced or metastatic colorectal cancer that has not responded to chemotherapy.~   "
268039|NCT00027599|"~     Phase II trial to study the effectiveness of APC8015 combined with bevacizumab in treating~     patients who have undergone radiation therapy and/or surgery and who have progressive~     prostate cancer. Biological therapies such as APC8015 use different ways to stimulate the~     immune system and stop cancer cells from growing. Monoclonal antibodies such as bevacizumab~     can locate tumor cells and kill them without harming normal cells. Combining monoclonal~     antibody therapy with biological therapy may kill more cancer cells.~   "
268040|NCT00017134|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. It is not yet known whether fenretinide given before surgery is more~     effective in preventing ovarian cancer than surgery alone.~      PURPOSE: Randomized clinical trial to compare the effectiveness of fenretinide followed by~     surgery with that of surgery alone in preventing ovarian cancer in patients who are at~     increased risk.~   "
268041|NCT00016315|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work~     in different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with~     chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with~     radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung~     cancer.~   "
268042|NCT00006225|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy.~      PURPOSE: Randomized phase I/II trial to study the effectiveness of peripheral stem cell~     transplantation in treating patients who have breast cancer or hematologic cancer.~   "
268043|NCT00005793|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating~     patients who have previously untreated acute myeloid leukemia.~   "
268044|NCT00005065|"~     Phase I trial to study the effectiveness of combining carboplatin and paclitaxel, radiation~     therapy with gadolinium texaphyrin, and surgery in treating patients who have stage IIIA~     non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more~     sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and surgery may~     kill more tumor cells.~   "
268047|NCT00059748|"~     Purpose:~      The purpose of this protocol is 1. To comprehensively evaluate patients with autoinflammatory~     diseases clinically, genetically and immunologically at the autoinflammatory disease clinic~     at the NIH. 2. To follow patients with autoinflammatory Diseases that are genetically defined~     including Neonatal-Onset Multisystem Inflammatory Disease (NOMID), the most severe clinical~     phenotype of Cryopyrin-Associated Periodic Syndromes (CAPS), Deficiency of IL-1 Receptor~     Antagonist (DIRA), Chronic Atypical Neutrophilic Dermatosis with Lipodystrophy and Elevated~     temperatures (CANDLE), and STING-Associated Vasculopathy with onset in Infancy (SAVI), and~     those with genetically undefined autoinflammatory disorders to determine long-term disease~     outcomes. 3. To develop biomarkers that help us assess disease activity and response to~     treatment. 4. To assess the eligibility of affected patients for inclusion in ongoing and~     planned treatment protocols.~      Goal: The goals of our studies are to understand the underlying immune dysregulation, to~     identify the genetic cause and to translate our findings into novel treatments that improve~     patients disease outcome.~      Eligibility:~        -  Patients with known NOMID/CAPS, DIRA, CANDLE, SAVI, CRMO, Still's Disease, and with~          other yet undifferentiated autoinflammatory diseases.~        -  Healthy adult and pediatric relatives.~        -  Volunteers~      Design:~      Participants will be evaluated at the NIH for 2-5 days. All participants will have a detailed~     medical history, physical exam, blood tests and other evaluations depending on the extend of~     their autoinflammatory disease.~      Participants may also expect the following assessments:~        1. Clinical test that help assess organ damage and functional impact such as hearing~          vision, memory and learning tests.~        2. Imaging studies to characterize the organ involvement of the inflammatory disease~          including: X-rays, CT scans, special MRIs, bone scans.~        3. Laboratory evaluations including clinical markers of disease activity, research samples~          for genetic studies, and blood samples for cytokine/biomarker assessment, and gene~          expression profiling.<TAB>~        4. Completion of questionnaires to assess disease activity and quality of life.~        5. If indicated, other procedures may be administered that include: a lumbar puncture if~          CNS inflammation is suspected and a skin biopsy if skin inflammation is present. other~          gastrointestinal procedures as they are clinically indicated.~        6. Patients my have a research skin biopsy taken.~      Participants may return for a single follow-up visits or for long term-follow up depending on~     their disease and willingness to be followed long-term.~   "
268048|NCT00019435|"~     RATIONALE: The LMB-9 immunotoxin may be able to locate tumor cells and kill them without~     harming normal cells. This may be an effective treatment for advanced solid tumors.~      PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients~     who have advanced solid tumors that have not responded to standard therapy.~   "
268049|NCT00002765|"~     RATIONALE: Immunotoxins can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of LMB-2 immunotoxin in treating patients~     who have leukemia or lymphoma.~   "
268050|NCT00059722|"~     The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with~     NSCLC after Failure of Prior Platinum-based Chemotherapy.~   "
268051|NCT00059709|"~     This study will evaluate the effectiveness of conflict resolution training for families with~     preschool and elementary school-aged children.~   "
268052|NCT00059696|"~     After a stroke, many patients are left with an impaired arm. Restricting the use of the good~     arm may improve the use of the bad arm. In Constraint-Induced Movement therapy (CI~     therapy), the good arm is put in a sling to force increased use of the bad arm. The bad arm~     is also trained each day for several weeks. This study will evaluate the effectiveness of CI~     therapy in patients with chronic disability after stroke and whether the rate of recovery is~     decreased in elderly patients.~   "
268053|NCT00059683|"~     Pregnant women who have a shortened cervix and have previously had a premature baby are at~     increased risk for having another premature baby. This study will determine whether~     reinforcing the cervix with a surgical stitch can reduce the chance of a premature birth.~   "
268054|NCT00018941|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. It~     is not yet known which regimen of interleukin-2 is most effective for kidney cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     interleukin-2 in treating patients who have metastatic kidney cancer.~   "
268055|NCT00005837|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who~     have recurrent or refractory cervical cancer.~   "
268056|NCT00005818|"~     Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating~     patients who have advanced colorectal cancer. SU5416 may stop the growth of colorectal cancer~     by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die~   "
268057|NCT00005025|"~     RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating women who have~     refractory or relapsed ovarian epithelial cancer, fallopian tube cancer, or peritoneal~     cancer.~   "
268058|NCT00002971|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine given before surgery~     to patients who have malignant glioma.~   "
268059|NCT00059670|"~     The aim of this research study is to determine the effectiveness of: 1) a traditional therapy~     regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box)~     musculature and 2) a new therapeutic exercise, the Shaker exercise.~      The primary objective of this 5-year project is to identify which of two therapy programs,~     the Shaker exercise versus traditional therapy, results in the largest number of stable,~     non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6~     weeks of intervention. The study is powered adequately so that this aim can be tested~     separately for head and neck cancer and stroke patients. Our primary outcome measure is~     return to oral feeding, i.e., 100% of nutrition and hydration by mouth.~   "
268060|NCT00059657|"~     Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia~     (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is~     designed to assess the efficacy and safety of the drug in the treatment of CLI.~   "
268061|NCT00059644|"~     Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia~     (CLI), which is the most severe form of peripheral arterial disease (PAD). This trial is~     designed to assess the efficacy and safety of the drug in the treatment of CLI.~   "
268062|NCT00003933|"~     RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect~     acute lymphocytic leukemia and determine the extent of disease.~      PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been~     treated for relapsed acute lymphocytic leukemia.~   "
268147|NCT00058838|"~     The primary purpose of this study is to determine whether sumanirole, at three different dose~     levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's~     disease~   "
268063|NCT00003926|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~     Chemoprotective drugs such as amifostine may protect normal cells from the side effects of~     high-dose chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side~     effects of peripheral stem cell transplantation in treating patients who have high-risk or~     relapsed solid tumors.~   "
268064|NCT00003925|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine,~     fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not~     responded to previous therapy.~   "
268065|NCT00003802|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients~     who have metastatic skin or eye melanoma.~   "
268066|NCT00003797|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating~     patients who have metastatic cancer of the pancreas that overexpresses HER2/neu.~   "
268067|NCT00059631|"~     Primary Objective:~      -Establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of weekly~     mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa.~      Secondary objectives:~        -  Evaluate the effect of bortezomib and mitoxantrone in combination on PSA levels among~          patients with baseline PSA levels >/=5 ng/mL who are treated near the maximum tolerated~          dose.~        -  Monitor the effect of escalating doses of bortezomib combined with mitoxantrone on~          selected parameters of clinical benefit (i.e. performance status, tumor-related~          symptoms, measurable disease response).~   "
268068|NCT00059618|"~     The goal of this clinical research study is to find the highest safe dose of PS-341 that can~     be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal,~     or fallopian tube cancer. Researchers also hope to find out if giving these drugs together~     will help shrink or slow the growth of tumors in patients who are considered resistant to~     platinum drugs. The safety of these drugs will also be studied.~   "
268069|NCT00059605|"~     The goal of this clinical research study is to find out the highest safe dose of~     DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung~     cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene~     (fus1) into cancer cells, using the drug DOTAP:Cholesterol-fus1. Researchers will also study~     the side effects of this experimental gene transfer at different doses, and will conduct~     tests to see if there are any effects on tumor size at different doses. Experimental transfer~     of the fus1 gene into humans has never been tried before.~      Objectives:~        -  Assess the toxicity of DOTAP:Cholesterol-fus1 Liposome Complex (DOTAP:Chol-fus1)~          administered intravenously.~        -  To determine the maximal tolerated dose and recommended phase II dose of DOTAP:Chol-fus1~          administered intravenously.~        -  Assess the expression of fus1 following intravenous delivery of DOTAP:Chol-fus1 in tumor~          and normal bronchial epithelial cell biopsies.~        -  Assess any anti-cancer activity for DOTAP:Chol-fus1.~   "
268070|NCT00059592|"~     Shingles is an infection commonly seen in children with a weakened immune system~     (immunocompromised children). The immune system can be weakened as a result of medications~     that patients receive for cancer or other serious illness or as a result of a bone marrow~     transplantation. Shingles in children with a weakened immune system may spread throughout the~     body and in some instances may be life-threatening. Acyclovir is a medication that is~     routinely used to treat immunocompromised children with shingles in order to prevent further~     spread of their shingles and to help them heal faster. Acyclovir is also given to bone marrow~     transplant patients to prevent reactivation of HSV infection.~      Valacyclovir is a new drug that is metabolized (broken down in the body) to acyclovir.~     Valacyclovir is given by mouth and studies done in adults have shown it to be more effective~     than acyclovir given by mouth.~      The purpose of this study is to~        -  study the pharmacology of this drug (how the body handles this drug),~        -  determine if oral Valacyclovir can be safely given to children with shingles, and~        -  determine the type of side effects that occur when oral Valacyclovir is given to~          immunocompromised children.~   "
268071|NCT00003757|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy consisting~     of rituximab in treating patients with refractory or recurrent hairy cell leukemia following~     cladribine therapy.~   "
268072|NCT00003649|"~     RATIONALE: Exposing tumor cells to the p53 gene may improve the body's ability to fight~     non-small cell lung cancer.~      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who~     have non-small cell lung cancer that cannot be surgically removed.~   "
268073|NCT00003627|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining chemotherapy with radiation therapy may kill more tumor cells and allow~     doctors to preserve the part of the body where the cancer started. It is not yet known~     whether radiation therapy with combination chemotherapy is more effective than radiation~     therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically~     removed.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus~     cisplatin and fluorouracil with radiation therapy alone in treating patients who have~     advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.~   "
268074|NCT00003484|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances,~     such as radioactive iodine, to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after~     radiation therapy in treating patients with newly diagnosed primary brain tumors that can be~     surgically resected.~   "
268075|NCT00003436|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may~     allow doctors to give higher doses of chemotherapy and kill more cancer cells. It is not yet~     known whether chemotherapy is more effective with or without bone marrow transplantation for~     acute myeloid leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or~     without bone marrow transplantation in treating children who have acute myeloid leukemia.~   "
268076|NCT00059579|"~     This study will use magnetic resonance imaging (MRI) to examine how the brain regulates~     emotions in healthy people and in patients who have major depression and anhedonia (loss of~     feeling of pleasure in things that normally give pleasure).~      Healthy normal volunteers and patients between 18 and 50 years of age with major depression,~     with or without significant anhedonia, are eligible for this study. Candidates will be~     screened with a psychiatric interview, a physical examination that will include blood and~     urine samples, and an electrocardiogram, and a questionnaire about their emotions.~      Participants will perform a monetary reward task while lying in an MRI scanner. The task is~     similar to playing a computer video game with the possibility of winning cash. The amount of~     cash is largely dependent on the subject's performance. The accumulated amount of cash earned~     in a session will fluctuate depending on the subject's continuing performance level. That is,~     during a single session, a subject could lose money earned early in the session if his or her~     performance later in the session is not as good as earlier.~      MRI pictures will be taken during performance of the task. MRI uses a magnetic field and~     radio waves to produce images of body tissues and organs. The patient lies on a table that is~     moved into the scanner (a narrow cylinder) and wears earplugs to muffle loud knocking and~     thumping sounds that occur during the scanning process. The procedure will last about 1 to~     1-1/2 hours.~   "
268077|NCT00059553|"~     Incomplete spinal cord injury often results in difficulty walking. Training on a treadmill~     with body weight support may improve walking ability after spinal cord injury. The purpose of~     this study is to examine the effect of treadmill speed on spinal cord function and walking~     performance.~   "
268078|NCT00059540|"~     This is a longitudinal, multi-site observational study of the long-term effects of a mother's~     use of cocaine and/or opiates during pregnancy on her infant. This observational study~     evaluates the medical, developmental, social, environmental, and neurobehavioral outcomes for~     1,400 of the original cohort of children. A series of follow-up examinations of these~     children were conducted in 5 phases: 1-36 months, 3.5-7 years, and 8-11 years. Children are~     currently being examined at 13 years of age.~   "
268079|NCT00059527|"~     To reduce the risk for chronic disease, adolescents should eat at least five servings of~     fruit and vegetables and be physically active daily. This study will implement and evaluate a~     school-based program to encourage adolescents to achieve and maintain a healthy diet and~     exercise regimen.~   "
268080|NCT00059514|"~     Michigan has the 10th highest smoking rate in the nation. Smoking rates are also very high in~     the Middle East and in Arab American families. The purpose of this study is to learn about~     tobacco use in Michigan Arab American youth ages 14 to 18. The study will evaluate why some~     young people start smoking and others do not. The study will also test an educational program~     designed to encourage young people to either quit tobacco use or to avoid it.~   "
268081|NCT00059449|"~     Necrotizing enterocolitis (NEC) is a serious gastrointestinal disorder that primarily affects~     preterm infants. About 10% of babies less than 32 weeks gestation at birth will develop it.~     Overall, 30% of babies who develop NEC will die from it, with many others developing long~     term gastrointestinal problems. The most important factor in its development is a premature~     intestinal tract. Epidermal growth factor (EGF) is an important growth factor in the~     development and maintenance of the gastrointestinal tract. This study will look for a~     relationship between EGF levels in premature babies and the development of NEC.~   "
268082|NCT00005836|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who~     have recurrent or refractory ovarian epithelial cancer or primary peritoneal cancer that has~     not responded to platinum-based chemotherapy.~   "
268083|NCT00059501|"~     This study will examine loss of balance in the elderly. Falls due to balance problems are a~     major health issue in older people, often resulting in bone fractures and other bodily~     injuries, and functional decline. In addition, the fear of falling leads some elderly people~     to restrict their movements and social activities, causing depressed moods and decreased~     enjoyment of life. Risk factors for falling in the elderly include some standing positions in~     which older people usually experience balance problems, such as leaning forward or backward.~     This study will examine these unstable positions and the brain mechanisms associated with~     loss of balance in the elderly.~      Normal volunteers between 20 and 90 years of age may be eligible for this study. Candidates~     must be in good health, with no difficulties in performing activities of daily living, and~     must be able to walk for at least 400 meters (1/4 mile). They will be screened with a medical~     history, physical examination, and blood tests.~      Participants will undergo the following three experiments:~        -  Movement task: The subject stands on a platform with markers placed at different parts~          of the body to record body movements. A cap with electrodes (metal disks) is placed on~          the head for electrocardiographic (EEG) recording of the electrical activity of the~          brain (brain waves) during the experiment. The positions of the feet on the platform are~          measured. While standing on the platform, the subject leans forward and backward as far~          as possible without losing balance. (Subjects are secured in a safety harness to prevent~          actual falls.) The task is repeated 5 times. The experiment lasts up to 2 hours.~        -  Postural response task: This study is identical to the first, except that the subject~          does not voluntarily lean forward and backward, but is pushed with a device to cause~          forward and backward movements. The experiment lasts 1 to 2 hours.~        -  Perceptual task: The subject sits in front of a computer screen and watches the postural~          movements of a human body model in forward and backward directions. When the subject~          recognizes an unstable position in the movements, he or she presses a computer mouse. An~          EEG records brain activity during the task, which lasts up to 2 hours.~   "
268084|NCT00059475|"~     This study will examine the effectiveness and side effects of an experimental vaccine to~     prevent recurrence of melanoma. The likelihood of melanoma returning is higher in patients~     who have melanoma lesions deep in the skin, in patients who have had positive lymph nodes,~     and in patients who have had surgery for metastatic disease (cancer that has spread beyond~     the primary site). Melanoma tumors produce proteins called glycoprotein 100 (gp100) and~     melanoma-associated antigen recognized by T cells 1 (MART-1). Vaccination with specific~     pieces of these proteins (peptides) may boost the immune system's fight against the cancer.~     The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which~     is intended to increase the immune response to the peptide.~      Patients 16 years of age and older whose melanoma has been surgically removed and who are~     currently free of disease may be eligible for this study. Candidates will be screened with a~     physical examination and blood and urine tests. An electrocardiogram (EKG), x-rays and other~     imaging studies will be done if recent results are not available. Some candidates may require~     heart tests, such as a cardiac stress test or echocardiogram, or lung function tests. In~     addition, all candidates will be tested for human leukocyte antigen (HLA) tissue type;~     patients must be type human leukocyte antigens (HLA-A)*0201, the type on which this vaccine~     is based.~      Participants will be randomly assigned to receive one of four different vaccines to determine~     which peptides offer the best immunity. Each treatment course consists of two injections of~     the vaccines every 3 weeks for four times. The injections are given under the skin of the~     thigh. After every other treatment course (every 6 months), patients will undergo a series of~     x-rays and scans to look for tumor. The immunizations may continue for up to 12 months as~     long as the melanoma does not return. The injections are given at the National Institutes of~     Health (NIH) Clinical Center. Patients are monitored for 1 hour after each injection and have~     blood tests and a physical examination to look for treatment side effects.~      Patients will be followed with blood tests every 12 weeks to monitor body functions. They~     will also undergo leukapheresis-a procedure to collect white blood cells-before starting~     treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect~     the action of the immune system cells. For this procedure, blood is drawn through a needle in~     the arm, similar to donating blood. The blood goes through a machine that separates out the~     lymphocytes (white blood cells), and the rest of the blood is returned through a needle in~     the other arm. Some patients may undergo a biopsy-surgical removal of a small piece of tissue~     under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects~     of the vaccines on the tumor immune cells.~      Patients whose disease returns during the first course of vaccine therapy will have surgery~     to remove the tumor and will continue to receive the vaccine treatment. Patients whose tumor~     returns after completing one course of therapy may receive a substance called interleukin-2~     (IL-2), which can boost immune function against the tumor. interleukin-2 (IL-2) is given~     intravenously (through a small tube placed in a vein) every 8 hours for 4 days. This regimen~     is repeated after 10 to 14 days. Those who respond to interleukin-2 (IL-2) will have a third~     course of treatment after 2 months. Patients whose disease recurs after treatment will be~     taken off the study and will be referred back to their referring physician or to another~     study, if an appropriate one is available.~   "
268085|NCT00059436|"~     The purpose of this study is to determine the effect of mental effort on improving muscle~     strength.~   "
268086|NCT00059410|"~     The TIPS Study, or Treatment and Illness Perceptions Survey, is a study funded by the~     national Alzheimer's Association to learn more about differences between African Americans'~     and Whites' attitudes, beliefs, and experiences related to Alzheimer's disease (AD). The~     study involves a one-time 30-minute telephone survey in which participants are asked about a~     range of topics related to AD, including their personal experiences, their beliefs about the~     disease's symptoms and risk factors, and their attitude toward possible future treatment~     options. Information from the survey will be used to develop more culturally sensitive health~     education and healthcare services for persons with AD.~   "
268087|NCT00059423|"~     In recent decades, hematologists have noticed that persons of African descent sometimes have~     lower white blood cell counts of a certain type, called granulocytes. These cells help to~     fight infections. The lower number of granulocytes in this situation does not appear to lead~     to more infections, and these individuals do not have any symptoms. This condition is called~     benign ethnic neutropenia (BEN), and is observed in a small percentage of individuals of~     African descent. This study will investigate the condition by studying people with and~     without BEN.~      The goals of this study are to:~        1. identify individuals of African descent with BEN.~        2. determine the effects of two drugs, G-CSF and dexamethasone, on granulocyte production~          and movement.~        3. determine whether there are differences in those with and without BEN in the way genes~          are stimulated after the administration of G-CSF and dexamethasone.~      Study participants will be asked to interview with the research team, undergo physical exams,~     donate a blood sample, and receive G-CSF by injection, followed by dexamethasone (orally)~     about three weeks later. They also will be required to undergo apheresis three times, a~     procedure in which blood is drawn from a donor and separated into its components. Some~     components are retained for research analyses, such as granulocytes, and small amount of~     blood; the remainder is returned by transfusion to the donor. This procedure will be required~     of participants before they receive G-CSF, the day after they receive G-CSF, and the day~     after they receive dexamethasone. Gene messages (mRNA will be isolated from granulocytes, and~     analyzed to better understand granulocyte growth and movement.~   "
268088|NCT00059397|"~     To compare MR imaging findings with biopsy for grading and staging early hepatitis C.~   "
268089|NCT00003432|"~     RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build~     an immune response to and kill their tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white~     blood cells in treating patients with metastatic breast cancer who have achieved a partial or~     complete response after chemotherapy and peripheral stem cell transplantation.~   "
268090|NCT00003346|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting~     of acetaminophen plus carmustine in treating patients who have stage III or stage IV~     melanoma.~   "
268091|NCT00003341|"~     RATIONALE: Drugs such as epoetin alfa may relieve anemia caused by chemotherapy. The best~     time for giving epoetin alfa during chemotherapy is not yet known.~      PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating~     anemia in patients with lymphoma, chronic lymphocytic leukemia, or multiple myeloma who are~     receiving chemotherapy.~   "
268092|NCT00003324|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high~     dose. Combining radiation therapy with surgery may be a more effective treatment for brain~     metastases.~      PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without~     surgery in treating patients who have brain metastases.~   "
268093|NCT00003311|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of different regimens of combination~     chemotherapy in treating patients with newly diagnosed mantle cell lymphoma.~   "
268094|NCT00059384|"~     Anti-HIV drugs are usually given to patients at fixed, standardized doses. This study will~     investigate alternative ways of dosing anti-HIV drugs to improve viral control.~      Study hypothesis: The optimal dosage regimen required to obtain the maximum benefit from~     antiretroviral therapy is achieved with strategies that control for pharmacokinetic and~     pharmacodynamic variability among patients.~   "
268095|NCT00059371|"~     The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This~     study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of~     HIV infections in young men.~   "
268096|NCT00059358|"~     This study will test the amount of anti-HIV drugs in the blood cells of HIV-infected patients~     who are also being treated for hepatitis C virus (HCV) infection.~   "
268097|NCT00059345|"~     Interactions between patients and healthcare providers may have a significant impact on a~     patient's response to therapy. In this study, patients with osteoarthritis (OA) of the knee~     will receive either acupuncture or sham acupuncture. The acupuncturists will be trained to~     interact with the patients in specific ways. The study will evaluate those interactions.~   "
268098|NCT00059332|"~     The goal of this study is to evaluate the effectiveness and safety of field-initiated~     magnesium sulfate in improving the long-term functional outcome of patients with acute~     stroke.~   "
268099|NCT00059319|"~     The purpose of this trial is to determine whether aortic manipulation in patients undergoing~     coronary bypass graft surgery leads to increased incidence of microemboli and subsequent~     impairment of neurobehavioral function.~   "
268100|NCT00059306|"~     The goal of this study is to learn if combination antiplatelet therapy (aspirin and~     clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and~     cognitive decline, and if intensive blood pressure control is associated with fewer recurrent~     strokes and cognitive decline.~      On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to~     an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the~     investigational anti platelet combination of aspirin + clopidogrel and an interim statistical~     analysis that demonstrated futility in the investigational anti platelet arm. It was~     recommended that patients be continued on standard care of aspirin mono therapy until their~     study close-out visit. Also, recommended the continuation and completion of the plood~     pressure arm following the protocol.~   "
268101|NCT00059293|"~     To use transcranial Doppler (TCD) ultrasound to detect stroke risk in children with sickle~     cell disease.~   "
268112|NCT00003173|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose thiotepa plus peripheral stem~     cell transplantation in treating patients with refractory solid tumors.~   "
268102|NCT00058981|"~     Randomized, double-blind, parallel-group study to evaluate safety and efficacy of multiple~     subcutaneous doses of DiaPep277 in patients with Latent Autoimmune Diabetes in Adults (LADA).~     Study medication will be administered at time 0, 1 and 3 months, and then every 3 months for~     a total of 8 administrations. The total duration of the trial is 24 months (treatment for 18~     months and follow-up for an additional 6 months). Patients will be male or female between the~     ages of 30 and 65 years, inclusive, within 2 to 60 months of the diagnosis of diabetes~     mellitus. Subjects must be positive for glutamic acid decarboxylate (GAD) autoantibodies. At~     the Screen Visit (Visit 2), all subjects will be asked to discontinue their use of all oral~     antidiabetic medications with the exception of metformin. The subjects will be placed on a~     stable regimen of insulin and diet (plus metformin if needed). Prior to the Baseline Visit~     (Visit 3), diabetic control must be achieved by diet and insulin (plus metformin if needed).~   "
268103|NCT00059280|"~     Pompe disease (also known as glycogen storage disease type II, GSD-II) is caused by a~     deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally,~     GAA is used by the body's cells to break down glycogen (a stored form of sugar) within~     specialized structures called lysosomes. In patients with Pompe disease, an excessive amount~     of glycogen accumulates and is stored in various tissues, especially heart and skeletal~     muscle, which prevents their normal function. This study is being conducted to evaluate the~     safety and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential~     enzyme replacement therapy for Pompe disease. Patients diagnosed with infantile-onset Pompe~     disease who are less than or equal to 6 months old will be studied.~   "
268104|NCT00059267|"~     Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver~     transplantation offers the only hope for patients who develop end-stage liver disease. Early~     results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and~     1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B~     immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence~     rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as~     intravenous infusion in high doses is very expensive, while long-term use of lamivudine is~     associated with drug resistance. Some studies found that preventive therapy using both HBIG~     and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of~     HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral~     medication, is effective against lamivudine resistant hepatitis B but its role in liver~     transplantation is uncertain because of the risk of kidney damage. Many studies showed that~     the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it~     may be possible to tailor the preventive therapy according to the risk. The aim of this study~     is to establish the most cost-effective preventive therapy for recurrent hepatitis B after~     liver transplantation.~   "
268105|NCT00059254|"~     Differences in how diet fats are converted to energy could explain some of the reported~     differences in health effects among different classes of dietary fat (e.g. monounsaturated~     vs. saturated). Recently, this laboratory showed that monounsaturated fats are turned into~     energy more readily than saturated fats. These results may mean that if one feeds more~     monounsaturated fatty acids (MUFA) and less saturated fatty acids (SFA) in the diet, body fat~     might accumulate at a lower rate. This could affect the risk of obesity and Type 2 Diabetes.~     This project has two principal Specific Aims which will be assessed in healthy young adults~     who are fed liquid formulas containing either an approximately equal amount of MUFA and SFA~     (controls) or a much greater amount of MUFA and much less SFA:~        1. To determine if a higher intake of MUFA and a reciprocally lower intake of SFA is~          associated with a higher rate of fat oxidation. We hypothesize that the rate of fat~          oxidation after eating will be higher in those subjects randomized to the MUFA-enriched~          diet compared to controls.~        2. To measure energy intake required to maintain constant body weight during each diet and~          to measure fat-free mass and fat mass, before and after each dietary change. We~          hypothesize that those on the high MUFA diet will need a higher energy intake required~          to maintain constant body weight.~   "
268106|NCT00059241|"~     Working with multiple schools in Brooklyn, NY, this study will develop and evaluate school-~     and community-based strategies designed to reduce early sexual activity and risky sexual~     behavior in middle school-aged children. These strategies will focus on parent education,~     classroom health curriculum, and learning through participation in community service.~   "
268107|NCT00059215|"~     The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as~     prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also~     referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in~     the heart using a catheter (a long thin tube) that has a small balloon on the end. In many~     cases, patients who have this procedure receive a stent, a small wire spring that helps keep~     the vessel open.~   "
268108|NCT00003290|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known whether standard radiation therapy is more effective than high-dose radiation therapy~     in treating patients with prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation~     therapy with that of high-dose radiation therapy in treating patients with stage II or stage~     III prostate cancer.~   "
268109|NCT00003262|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens~     in treating patients with Hodgkin's disease and HIV infection.~   "
268110|NCT00003205|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with~     stage IV breast cancer.~   "
268111|NCT00003193|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of~     chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel and radiation therapy plus~     chemoprotection with amifostine in treating patients with stage III or stage IV head and neck~     cancer.~   "
268113|NCT00059228|"~     This study evaluates the efficacy of estrogen treatment in women with postpartum depression~     (PPD).~      PPD causes significant distress to a large number of women; the demand for effective~     therapies to treat PPD is considerable. Estradiol therapy has a prophylactic effect in women~     at high risk for developing PPD. The prevention of a decline in estradiol levels may prevent~     the onset of PPD. Studies also suggest that estradiol has antidepressant effects in women and~     may provide a safe and effective alternative to traditional antidepressants in women with~     PPD.~      Participants will be screened with a medical history, physical examination, blood and urine~     tests, psychological tests, genetic studies, and self-rating scales and questionnaires. Upon~     study entry, women will be randomly assigned to wear skin patches containing either estradiol~     or placebo (a patch with no active ingredient) for 6 weeks. Women who receive estradiol and~     do not menstruate during the last week of the study will receive progesterone for 7 days to~     initiate menstruation. Women who receive placebo and do not menstruate during the last week~     of the study will continue to receive placebo at the end of the study. Every week,~     participants will have blood taken and will be asked to complete symptom self-rating scales.~     A urine sample and blood samples will be collected at different time points through out of~     the study. Participants who receive placebo and those whose symptoms do not improve with~     estradiol therapy will be offered treatment with standard antidepressant medications for 8~     weeks at the end of the study.~   "
268114|NCT00059202|"~     This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for~     patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be~     approximately five years with important clinical endpoints such as death, eligibility for~     liver transplantation, changes in histology and cholangiogram as well as liver biochemistries~     and quality of life data collected.~   "
268115|NCT00059189|"~     This study will examine whether blind people develop changes in the brain that improve memory~     function. Previous studies have shown that blind people, on average, perform better in memory~     tasks than sighted people. A possible reason for this is that parts of the brain that process~     visual information in sighted individuals are engaged in processing mnemonic (remembering)~     information in blind people.~      Blind and sighted people 18 years of age and older are eligible for this study. Healthy,~     sighted individuals may participate in Part 1 of the study, which is designed to find~     appropriate words to use in tests for Part 2 of the study. Part 2 will include sighted people~     and blind people. It will examine whether the (visual) brain in blind people is processing~     mnemonic information in a way that helps with day-to-day memory functions. Blind participants~     in this study must have lost their sight by age 4. Candidates will be screened with a medical~     interview and examination and a brief test of short-term and long-term verbal memory. Sighted~     patients will also be tested for visual memory and for handedness.~      Part 1 - Word Recognition Testing (2 sessions)~        -  Session 1: Participants listen to a number of words over a loudspeaker and try to~          remember them for a memory test that will be given 30 minutes later. For the test,~          subjects listen to words again and press one of three buttons as quickly as possible~          after hearing the word. The buttons signal whether the subject does or does not~          recognize the word with a 1) high level of confidence or 2) low level of confidence.~        -  Session 2: Participants hear a noun over a loudspeaker and have to find an appropriate~          verb for it, such as the verb (read) for the noun (book).~      Part 2 - MRI Scanning and TMS Experiments (5 - 7 sessions)~        -  Magnetic resonance imaging (MRI): Participants perform the same procedures as described~          above for Part 1 while undergoing MRI of the brain. For this test, the subject lies on a~          table inside the MRI scanner - a narrow cylindrical tube with a strong magnetic field.~          Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and~          90 minutes. (Earphones are used to hear the words for this test instead of a~          loudspeaker.)~        -  Transcranial magnetic stimulation (TMS): Participants undergo TMS while performing the~          same procedures described for Part 1. For TMS, a wire coil is held over the scalp. A~          brief electrical current is passed through the coil, creating a magnetic pulse that~          stimulates the brain. Subjects may hear a click and feel a pulling sensation on the skin~          under the coil. There may be a twitch in muscles of the arm or leg. During the TMS,~          electrical muscle activity is recorded through the electrodes with a computer or other~          recording device. Each session lasts a maximum of 3 hours.~   "
268116|NCT00005839|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin combined with capecitabine~     in treating patients who have metastatic or recurrent solid tumors.~   "
268117|NCT00004220|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and gemcitabine in treating~     patients who have advanced cancer.~   "
268118|NCT00059137|"~     This study will evaluate the effectiveness of a flexible belt device in guiding patient~     breathing during computed tomography (CT)-guided needle biopsy. When patients undergo CT~     scanning to help guide the physician during a tissue biopsy, they are usually asked to hold~     their breath while the scan is taken of certain parts of the body. When the first scan is~     completed, the patients are allowed to breathe, and are then asked to hold their breath again~     while the needle is advanced towards the tissue to be biopsied. Since body organs and tissues~     move with breathing, this study will try to stop the patient's breathing at the same place in~     the breathing cycle to ensure that the biopsy target stays still and in the same place. This~     study will see if the flexible belt, used with a computer screen that charts the patient's~     breathing, will improve the patient's ability to stop breathing at the same place in the~     breathing cycle before and during the biopsy.~      Patients 18 years of age and older who have a lesion requiring a needle biopsy in the chest~     or abdominal area may be eligible for this study. The biopsy procedure must require CT scan~     guidance.~      Participants will undergo the following procedures:~        -  Breathing exercise: A flexible, loose-fitting belt is placed around the patient's~          abdomen and the patient is asked to stop breathing in the following ways: 1) take a deep~          breath in and hold; 2) breathe deeply out and hold; and 3) breathe regularly and hold.~        -  Needle biopsy: The patient is positioned in a CT scanner and is asked to hold his or her~          breath while an initial scan is taken. Then the patient is taken out of the scanner and~          the place the needle entry site for the biopsy is marked on the skin. A local anesthetic~          is applied to the site and the patient is asked to hold his or her breath the same way~          as before. During this breath hold, the patient may or may not be shown a computer~          screen displaying a graph of the patient's breathing and the point in the cycle of the~          previous breath hold. The biopsy is then performed with CT guidance. While the CT~          pictures are being taken, the patient is again asked to breathe and hold his or her~          breath as before. When the biopsy is completed, the belt device is removed.~   "
268119|NCT00059124|"~     To study the epidemiology of aortic calcium.~   "
268120|NCT00059111|"~     To identify the early effects of obstructive sleep apnea on the cardiovascular system of~     children.~   "
268121|NCT00059098|"~     To find genes important in the susceptibility to coronary heart disease.~   "
268122|NCT00004257|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug and combining chemotherapy with radiation therapy may kill more~     tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil~     plus radiation therapy in treating patients who have primary esophageal or stomach cancer.~   "
268123|NCT00004243|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of docetaxel and oxaliplatin in treating~     patients who have metastatic or recurrent solid tumor.~   "
268136|NCT00058955|"~     The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid~     (GHB) by comparing its physiological, behavioral and subjective effects with those of several~     other drugs.~   "
268124|NCT00003597|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may~     increase the number of immune cells found in bone marrow or peripheral blood and may help a~     person's immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating~     children who have recurrent or refractory solid tumors and who are receiving chemotherapy.~   "
268125|NCT00003163|"~     RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of~     chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation in~     treating patients who have multiple myeloma or other B-cell cancers.~   "
268126|NCT00003162|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known which radiation therapy regimen is more effective for bone metastases.~      PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in~     treating patients who have bone metastases from breast or prostate cancer.~   "
268127|NCT00003129|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with~     early-stage bladder cancer that has not responded to BCG therapy.~   "
268128|NCT00003124|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using~     leuprolide and flutamide may fight prostate cancer by reducing the production of androgens.~     Combining radiation therapy with hormone therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy~     in treating patients with prostate cancer.~   "
268129|NCT00003064|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and autologous~     peripheral stem cell transplantation in treating patients with recurrent or persistent~     epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.~   "
268130|NCT00002972|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who~     have unresectable stage IIIB, stage IV or recurrent lung cancer.~   "
268131|NCT00059046|"~     Serotonin is a chemical involved in the regulation of emotions, anxiety, sleep, stress, and~     other body functions. The purpose of this study is to use brain imaging technology to study~     how serotonin works in the brain.~      The serotonin transporter (SERT) regulates the release of sertonin throughout the body. Until~     recently, radioactive chemicals called tracers were not suitable for viewing SERT activity.~     However, a newly developed tracer called [11C]DASB can be used with positron emission~     tomography (PET) imaging to view the parts of the brain that use serotonin.~      Participants in this study will be screened with medical and psychiatric examinations, an~     electrocardiogram (EKG), and blood and urine tests. This study comprises two parts. During~     Part 1, participants will undergo a whole-body PET scan. During Part 2, participants will~     undergo a magnetic resonance imaging (MRI) scan of the brain. At the next study visit,~     participants will have one or two PET head scans. If not is not possible to perform both~     scans on the same day, an additional visit will be scheduled for the second PET scan.~   "
268132|NCT00059033|"~     This study will conduct tests in patients with primary chronic autonomic failure (CAF) to~     learn more about these disorders, which include pure autonomic failure, multiple system~     atrophy, Parkinson's disease with autonomic failure, and autoimmune autonomic neuropathy.~      Healthy volunteers and patients with primary CAF 18 years of age or older may be eligible for~     this study. Participants undergo some of the following tests:~        -  Blood studies, including arterial catheter insertion to measure blood pressure and~          collect arterial blood samples, blood flow studies using sensors applied to the skin and~          a pressure cuff around a limb, and blood draw for genetic studies.~        -  Bladder motility: Ultrasound test of bladder function.~        -  Electrocardiogram and heart ultrasound.~        -  Responses to changes in temperature: Warm water and then room temperature water are~          passed through watertight pads applied to the back and front of the body and body~          temperatures are measured.~        -  Gastrointestinal motility: Bowel sounds are recorded using a microphone placed on the~          abdomen.~        -  Lower body negative pressure: The lower body is placed into an airtight barrel-like~          chamber. Some air is sucked out of the barrel, causing blood to pool in the legs, as~          occurs during standing.~        -  Lumbar puncture: A needle is inserted in the space between the bones in the lower back~          to collect a small sample of cerebrospinal fluid.~        -  Microdialysis to measures levels of chemicals in the body fluid of certain tissues. A~          solution is passed through a thin tube inserted into the skin. Chemicals in the body~          tissues enter the solution. The solution is collected and the chemical levels are~          measured.~        -  PET scanning: A nuclear medicine test to produce images of body organs. For patients~          with urinary problems, a catheter is inserted into the bladder before starting the scan.~        -  Pupillometry: The pupil of the eye is measured using a special camera in a~          light-controlled room.~        -  QSART. A small amount of a brain chemical is applied to the skin with a tiny amount of~          electricity, and the sweat in a nearby patch of skin is measured.~        -  Measurement of saliva production, using a cotton-like material placed between the teeth~          and gums to absorb saliva.~        -  Skin electrical conduction test, using sensors on the skin to measure sweat production.~        -  Skin and core temperature measurements using sensors on the skin and in the ear canal.~        -  Speech and swallowing assessment for patients with speech and swallowing difficulties.~        -  Stress echocardiogram: A catheter is placed in the subject's arm for sampling blood or~          giving a drug while the subject exercises. During the test, blood pressure, pulse rate,~          and EKG are continuously monitored.~   "
268133|NCT00059020|"~     This study will examine tissue from gliomas (a type of brain tumor) removed during surgery~     for gene mutations, or changes, thought to be involved in tumor formation and growth. One~     common gene mutation causes the receptor for a protein called epidermal growth factor (EGF)~     to be in an active state all of the time, allowing uncontrolled cell growth that can lead to~     tumor formation. This study will analyze blood and tumor tissue samples from patients with~     gliomas for:~        -  Changes in the EGF gene in the tumor~        -  Changes in other genes, such as that for the EGF receptor (EGFR)~        -  Changes in levels of EGF and EGFR, and in other proteins and genes that respond to~          changes in the levels of these proteins in the tumor~        -  Changes in the EGF gene and protein in the blood~      The study will also determine if production of EGF and EGFR obtained from glioma and from~     blood cells derived from the tumor can be altered in the laboratory to grow indefinitely in~     culture.~      Patients between 18 and 75 years of age with a brain tumor that requires surgical treatment~     may be eligible for this study.~      Participants will be admitted to the NIH Clinical Center for about 3 to 10 days. They will~     have a physical and neurological examination, blood and urine tests, other tests, if~     medically necessary, and will be evaluated and prepared for surgery. During surgery, as much~     of the tumor as possible will be removed. A small amount of the tumor tissue will be~     collected for this study. No tissue will be removed for this study that would not otherwise~     have been removed. Some of the tissue will be used to culture glioma cells and the rest will~     be frozen and stored for examination, as described above. If any normal-appearing brain~     tissue is removed during surgery in order to enhance safety in removing the tumor, the normal~     tissue will be studied as well. Brain tissue that appears normal will not be removed strictly~     for research.~      During surgery and the day after surgery, a blood sample will be drawn from a catheter~     (plastic tube) that was placed in an artery or vein for surgery. If catheters are no longer~     in place, blood will be drawn through a needle in a vein.~   "
268134|NCT00058994|"~     The purpose of this study is to demonstrate that anecortave acetate is superior to placebo in~     maintenance of visual acuity at the 12- and 24-month visits.~   "
268135|NCT00058968|"~     The purpose of the study is to determine if duloxetine can help patients with painful~     diabetic neuropathy.~   "
268137|NCT00058942|"~     This study is being conducted in Sonoma County, California.~      Gastrointestinal illness and diarrhea are recognized as a significant cause of morbidity and~     mortality in the elderly. One study showed that 51% of deaths caused by diarrhea over a~     9-year period occurred in individuals over the age of 74 years. Although many infectious~     diseases are more problematic in the elderly because of a decline in immune function and a~     higher incidence of pre-existing malnutrition and dehydration, it is still not known what the~     principal modes of transmission are and which infectious agents are responsible.~      The principal objective of this study is to evaluate the ability of in-home treatment of~     tapwater to reduce gastrointestinal illness in non-institutionalized elderly individuals. The~     trial will test household-level treatment of drinking water by joint use of ultraviolet light~     and filtration devices. A secondary objective is an estimate of the incidence of specific~     bacterial, viral, and protozoan agents in stool specimens collected from elderly individuals~     with gastrointestinal symptoms that might be related to water consumption.~   "
268138|NCT00058929|"~     This trial is a study of Remodulin in patients with pulmonary arterial hypertension who have~     been transitioned from Flolan therapy. The study consists of Screening, Baseline and~     Treatment Phases.~      Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the~     Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and~     symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion~     criteria, patients will be assigned to study drug (Remodulin or placebo) and will enter the~     Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which~     patients will begin receiving subcutaneous study drug at a low dose determined by the~     patient's current dose of Flolan. The study drug dose will be increased gradually while the~     Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will~     continue until Flolan therapy has been discontinued and the patient is stable on study drug.~      Patients who are transitioned off Flolan, who are stable on study drug will be discharged~     from the clinic, and will continue to receive study drug on an outpatient basis. The patient~     will return to the clinic at Weeks 4 and 8 for assessments. Patients will remain on study~     drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be~     conducted and the patient will be dismissed from the study. Patients who successfully~     complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the~     investigator's discretion.~   "
268139|NCT00058903|"~     The goal of this study is to find an effective and well-tolerated medical therapy for itching~     due to liver disease. Persons with primary biliary cirrhosis or chronic hepatitis C are~     currently being enrolled in the study. Persons participating in the study are given~     sertraline, a medication which is also often used for depression,to treat their itching. The~     dose is gradually increased as the effect on itching and any other potential side effects are~     carefully monitored.~   "
268140|NCT00058890|"~     In this study, the effect of the medication gabapentin to treat itching secondary to liver~     disease is being studied.~      There are some funds to cover travel expenses for patients who are not from New York (NY).~      Gabapentin is approved to treat seizures in human beings. In this study, patients with liver~     disease who meet inclusion criteria are admitted to the research hospital of the New York~     Presbyterian Hospital to record scratching behavior by the use of a machine designed for that~     purpose. Blood work will be obtained. After completion of recording, patients are assigned by~     chance to receive active medication or placebo (a capsule that does not contain active~     medication). The patients will come to the outpatient office of the research hospital 2 weeks~     into the study for an interview and blood work. After 4 weeks, patients are readmitted to the~     hospital to record scratching behavior. After data are collected, the code is broken, if~     patient had been on inactive drug, active drug will be supplied as per protocol for 4 weeks.~     Blood work will be obtained. If patient had been randomized to active medication, the study~     will provide one week supply of drug. After that, the referring physician, with whom the~     study was previously discussed, could prescribe the medication as it is available.~   "
268141|NCT00002945|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.~      PURPOSE: Phase III trial to study the effectiveness of high-dose combination chemotherapy,~     peripheral stem cell transplantation, and interleukin-2 in treating patients who have acute~     myeloid leukemia.~   "
268142|NCT00002934|"~     RATIONALE: The evaluation of breast cancer recurrence rates may improve the ability to plan~     cancer treatment for patients with breast cancer.~      PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had~     surgery for ductal carcinoma in situ.~   "
268143|NCT00002835|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of~     combination chemotherapy in treating patients who have intermediate-grade or immunoblastic~     lymphoma.~   "
268144|NCT00002822|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug is a way to kill more tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy~     regimens followed by radiation therapy in treating patients with small cell lung cancer.~   "
268145|NCT00058864|"~     HIP PRO is a multicenter randomized, controlled trial of an energy absorbing and distributing~     padding system designed to reduce the incidence of hip fractures in 546 nursing home (NH)~     residents. The trial is being conducted in three geographic regions of the US: Boston, St.~     Louis, and Baltimore. Non bed- or chair-bound residents over the age of 65 are given~     protective underwear containing a single pocket and hip pad so that each resident becomes~     his/her own control. During the trial, hip fracture incidence will be compared in padded and~     unpadded hips using an intent to treat analysis. A secondary aim is to identify resident and~     facility factors contributing to non-adherence with the use of the hip protector.~   "
268148|NCT00058825|"~     Patients are being asked to participate in this study because they have a cancer in their~     blood, Fanconi's Anemia, or have been unsuccessfully treated for bone marrow failure such as~     Aplastic Anemia or Paroxysmal Nocturnal Hemoglobinuria. Any of these conditions could benefit~     from an allogeneic stem cell transplant using a donor that is related to the patient.~      Stem cells are created in the bone marrow. They grow into different types of blood cells that~     the patient needs, including red blood cells, white blood cells, and platelets. In a~     transplant, the patient's own stem cells are killed and then replaced by stem cells from the~     donor.~      Usually, patients are given very strong doses of chemotherapy prior to receiving a stem cell~     transplant. However, because of the patient's condition, they have a high risk of~     experiencing life-threatening treatment-related side-effects. Recently, some doctors have~     begun to use chemotherapy that does not cause as many side-effects before patients receive a~     transplant.~      This research study adds CAMPATH 1H to a low-dose chemotherapy regimen, followed by an~     allogeneic stem cell transplantation. We want to see whether adding CAMPATH 1H to the~     transplant medications helps in treating the disease. We also want to see whether there are~     fewer life-threatening side-effects from the treatment. CAMPATH 1H is a drug that is still~     being studied. CAMPATH 1H stays active in the body for a long time after patients receive it,~     which means it may work longer at preventing graft-versus-host-disease (GvHD) symptoms.~   "
268149|NCT00058812|"~     Patients have a type of blood cell cancer or other blood problem that is very hard to cure~     with standard treatments and s/he will receive a bone marrow transplant. If the patient does~     not have a brother or sister whose marrow is a perfect match, this bone marrow will come~     from a donor whose marrow is the best match available. This person may be a close relative or~     an unrelated person whose bone marrow best matches the patient's, and who agrees to donate~     marrow.~      In normal people, the Epstein-Barr (EB) virus infection causes a flu like illness and usually~     gets better when the immune system controls the infection. The virus, however, remains hidden~     in the body for life. After a transplant, while the new immune system is growing back, the EB~     virus can come out and infect cells and cause them to grow in an uncontrolled manner.~     Patients can develop fevers, swollen lymph nodes and damage to other organs such as kidneys~     and lungs. This infection acts like a cancer because the cells infected with EB virus grow~     very quickly and there is no known effective treatment. This sort of infection will occur in~     between 10-30% of patients receiving a transplant from a donor who is not a perfect match,~     and has been fatal in nearly all these cases.~      This infection occurs because the immune system cannot control the growth of the cells. We~     want to see if we can prevent it from happening or treat it by giving the patient a kind of~     white blood cell called T cells that we have grown from the marrow donor. These cells have~     been trained to attack EB virus infected cells. We will grow these T cells from blood taken~     from the donor at the time of bone marrow harvest. These T cells will be stimulated with the~     donor's EB virus-infected cells which have been treated with radiation so they cannot grow.~     After mixing these cells together we will be able to grow special T cells from the donor that~     can attack EB virus infected cells. We will then collect the T cells and make sure they can~     kill the virus infected cells. These EBV specific T cells are an investigational product not~     approved by the Food and Drug Administration.~   "
268150|NCT00058799|"~     This research study is to determine the safety and dosage of special cells that may make the~     patients own immune system fight the leukemia. To do this we will put special genes into~     cells called fibroblasts that we have grown in the laboratory from a skin sample. The genes~     we put in these fibroblasts make them produce substances called CD40 Ligand (CD40L) and~     interleukin-2 (IL-2). These are natural substances that may help the immune system kill~     leukemia cells. Some of these fibroblasts producing CD40L and IL-2 mixed with a small~     quantity of the leukemic cells will then be put back into the body.~      Studies of cancers in animals and in cell lines suggest that substances like CD40L and IL-2~     when mixed with cancer cells do help the body to recognize and kill these cancer cells. A~     treatment using IL-2 has been previously used in more than 40 children with neuroblastoma and~     similar treatments are being used in adults with other cancers. Some of the patients have~     shown significant tumor responses. However, we do not know if this treatment will work and we~     do not know the right amount of each of the special cells to use, so different patients will~     get different combination and numbers of cells.~      The purpose of this study is to learn the side effects and safe dosage of these special~     cells.~   "
268151|NCT00058786|"~     This is a research study to determine the safety and dosage of special cells that may make~     the patients own immune system fight the cancer. To do this, we will put a special gene into~     cancer cells that have been taken from the patient. This will be done in the laboratory. This~     gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may~     help the immune system kill cancer cells. Additionally, we will stimulate the cancer cells~     with another natural protein called CD40 ligand (CD40L), which preclinical human and animal~     studies suggest will help IL-2 perform better. Some of these cells will then be put back into~     the body. The cells are grown with normal embryonic fibroblasts. Studies of cancers in~     animals and in cancer cells that are grown in laboratories suggest that combining substances~     like IL-2 and CD40L helps the body kill cancer cells.~      The purpose of this study is to learn the side effects and the safest effective dose of these~     special cells on the disease~   "
268152|NCT00058773|"~     Subjects have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma, which has~     come back or not gone away after treatment, including the best treatment we know for relapsed~     Lymphoma. We are asking subjects to volunteer to be in a research study using Epstein Barr~     virus (EBV) specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has~     never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it~     has been used successfully in children with other types of blood cancer caused by EBV after~     bone marrow transplantation.~      Some patients with Hodgkin disease or non-Hodgkin Lymphoma show evidence of infection with~     the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time~     of their diagnosis of Lymphoma. EBV is often found in the cancer cells suggesting that it may~     play a role in causing Lymphoma. The cancer cells infected by EBV are very clever because~     they are able to hide from the body's immune system and escape destruction. We want to see if~     we can grow special white blood cells, called T cells, that have been trained to kill EBV~     infected cells and give them back to subjects.~   "
268153|NCT00058760|"~     This study will evaluate the effectiveness of a program designed to prevent early sexual~     behavior in middle school-aged African American girls.~   "
268154|NCT00058747|"~     This is a Phase II, exploratory, open-label study of the investigational product AG-858, in~     patients who are cytogenetically positive after treatment with Gleevec.~      The trial will consist of three independent Phase II evaluations of patient groups according~     to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a,~     4b, and 4c).~   "
268165|NCT00058656|"~     Patients will have immune cells collected and then expanded outside of the body. Patients~     will receive an infusion of a large number of expanded immune cells. There will be three dose~     levels studied. The goal of the study will be to determine the safety as well as potential~     efficacy of this treatment.~   "
268155|NCT00058734|"~     The aim of this trial is to find out if immune responses to HIV can be boosted in individuals~     who start medicines soon after being infected. If immune responses can be boosted to the~     virus, this may allow the body to control HIV without the need for medications. This study is~     designed to test a new strategy for boosting immune responses to HIV and to evaluate if these~     responses allow people to have control of HIV without medicines.~   "
268156|NCT00058721|"~     This study will use single photon emission computed tomography, or SPECT (see below), to~     examine brain nicotine receptors in evaluating the role of a chemical called acetylcholine in~     memory and other problems in Parkinson's disease (PD). Acetylcholine acts by binding to these~     nicotine receptors.~      Healthy normal volunteers and patients with Parkinson's disease 40 years of age and older,~     with or without dementia, may be eligible for this study. Candidates will be screened with~     physical and neurological examinations, a pen and paper test of memory and other mental~     functions, blood tests, and, for women of childbearing potential, a pregnancy test. Patients~     with cognition problems will have more intensive mental function tests.~      All participants will undergo the following procedures:~        -  Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves~          to show structural and chemical changes in the brain. During the scan, the subject lies~          on a table in a narrow cylinder (the scanner). The time required in the scanner is about~          1 hour, during which the subject is asked to lie very still for 10 to 15 minutes at a~          time. He or she can speak with a staff member via an intercom system at all times during~          the procedure.~        -  SPECT: This nuclear medicine test produces a picture of the receptors in the brain. On~          the night before the scan, the day of the scan, and for 4 days after the scan, subjects~          take an oral dose of potassium iodide to protect the thyroid gland from the radioactive~          tracer used in the SPECT procedure. (People allergic to potassium iodide will take~          potassium perchlorate instead.) Before the scan, small radioactive markers containing~          99Tc are glued to the subject's head. Two catheters (thin, flexible tubes) are placed in~          veins in the arms to inject the radioactive tracer [123I]5-I-A-85380 and to draw blood~          samples. Another catheter is placed in an artery in the wrist to draw arterial blood~          samples. During the scan, the subject lies on a bed with his or her head held still with~          a head holder. The scans are taken over a 6-hour period after injection of~          [123I]5-I-A-85380. An electrocardiogram, respiration, and blood pressure measures are~          taken before the tracer is injected, then 5 minutes after the injection, and again 30 to~          60 minutes after the injection. Blood and urine samples are collected 5 to 6 hours after~          starting the scan. Participants are asked to urinate at least every 2 hours for 12 hours~          after injection of [123I]5-I-A-85380 to decrease radiation exposure.~   "
268157|NCT00058695|"~     This study will examine whether certain polymorphisms (small gene variances) predispose~     people to develop age-related macular degeneration (AMD). This eye condition affects people~     over 50 years of age and can cause permanent loss of central vision. The study will examine~     and compare the frequency of polymorphisms in patients with AMD to that of individuals~     without AMD. This information will help identify genetic risk factors for the AMD and may~     lead to the development of more effective treatments.~      Patients 50 years of age and older with advanced AMD and healthy normal volunteers may be~     eligible for this study. All participants will provide an eye health history and will have 10~     milliliters (2 teaspoons) of blood drawn from an arm vein. The DNA in the blood will be~     isolated and tested for certain genes that other research indicates are important in aging~     and age-related diseases. The normal and polymorphic gene sequences will be identified and~     compared in patients with AMD and control subjects to determine if any of the polymorphisms~     are related to development of AMD.~      In addition, control subjects will have a routine eye examination, including dilation of the~     pupils for examination of the back of the eye.~   "
268158|NCT00058682|"~     Fluconazole is an FDA-approved drug that is widely used to treat fungal infections due to~     candida. The experimental drug anidulafungin has been found to be active in treating~     life-threatening fungal infections. The purpose of this study is to determine whether~     anidulafungin is as effective as fluconazole in treating candidemia, an invasive form of~     candidiasis.~      Three hundred patients 16 years of age or older will participate in this study. Participants~     will be randomly assigned to one of two groups: one-half will receive anidulafungin; the~     other half will receive fluconazole. They will receive the drug for as few as 10 days or for~     up to 42 days, depending on the seriousness of the infection. The drug will be given over a~     four-hour period on the first day, and over two hours on the remaining days. While taking the~     study medication, participants will be required to give blood samples every week until the~     end of treatment. At two weeks and six weeks following the end of therapy, participants will~     return for evaluation.~      Prior to their participation in this study, patients will undergo the following evaluations:~     a physical exam, an eye exam, an electrocardiogram, and possibly blood work.~   "
268159|NCT00058669|"~     To examine potential differences in the prevalence and pattern of risk factors for coronary~     heart disease in a sample of 500 self-identified lesbians and 500 heterosexual women, matched~     for age, socioeconomic status, and ethnicity.~   "
268160|NCT00002777|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.~      PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that~     of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast~     cancer.~   "
268161|NCT00002701|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Bone marrow transplantation may be able to replace immune cells~     that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of~     combination chemotherapy with or without bone marrow transplantation is more effective in~     treating promyelocytic leukemia~      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination~     chemotherapy regimens with or without bone marrow transplantation in treating patients who~     have promyelocytic leukemia.~   "
268162|NCT00002695|"~     RATIONALE: Diagnostic procedures, such as analysis of tumor tissue and lymph nodes that have~     been surgically removed, may improve the treatment of patients with cancers of the head and~     neck.~      PURPOSE: Diagnostic trial to determine if analyzing tumor tissue and lymph nodes surgically~     removed from patients with cancers of the head and neck can predict recurrence of the cancer.~   "
268163|NCT00002693|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with~     carboplatin and topotecan in treating patients with chronic myelogenous leukemia or recurrent~     acute leukemia.~   "
268164|NCT00002669|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells.~     Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not~     yet known which treatment regimen is more effective in treating melanoma.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of~     combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have~     metastatic melanoma.~   "
268166|NCT00002658|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Biological therapies use different ways to stimulate the immune~     system and stop cancer cells from growing. Combining chemotherapy with bone marrow~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different treatment~     regimens in treating patients who have acute myeloid leukemia.~   "
268167|NCT00002653|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is most effective in treating older patients~     with multiple myeloma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without cyclophosphamide and prednisone in treating older patients with multiple~     myeloma.~   "
268168|NCT00002575|"~     RATIONALE: Less invasive types of surgery may help reduce the number of side effects and~     improve recovery. It is not yet known which type of surgery is more effective for colon~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted~     colectomy with open colectomy in treating patients who have colon cancer.~   "
268169|NCT00002550|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor~     cells. It is not yet known if chemotherapy plus radiation therapy is more effective with or~     without surgery for lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combining cisplatin,~     etoposide, and radiation therapy with or without surgery in treating patients who have stage~     IIIA non-small cell lung cancer.~   "
268170|NCT00002539|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of~     immune cells found in bone marrow or peripheral blood and may help a person's immune system~     recover from the side effects of chemotherapy. It is not yet known whether chemotherapy and~     surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients~     with osteosarcoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness combination chemotherapy and~     surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma.~   "
268171|NCT00058617|"~     Patients have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma which has~     come back or not gone away after treatment, including the best treatment known for relapsed~     Lymphoma.~      Patients are being asked to volunteer to be in a research study using Epstein Barr virus~     specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been~     used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been~     used successfully in children with other types of blood cancer caused by EBV after bone~     marrow transplantation. Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of~     infection with the virus that causes infectious mononucleosis Epstein Barr virus before or at~     the time of their diagnosis of the Lymphoma. EBV is often found in the cancer cells~     suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are~     very clever because they are able to hide from the body's immune system and escape~     destruction. Investigators want to see if it's possible to grow special white blood cells,~     called T cells, that have been trained to kill EBV infected cells.~      Purpose The purpose of this study is to find the largest safe dose of EBV specific cytotoxic~     T cells, to learn what the side effects are and to see whether this therapy might help~     patients with Hodgkin disease and non-Hodgkin Lymphoma.~   "
268172|NCT00058604|"~     Patients who may have been infected with EBV (Epstein-Barr Virus) before or after the time of~     their transplant have a higher risk of developing Lymphoproliferative Disease (LPD) or may~     already have a form of this disease.~      This research study uses Epstein Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs).~     These cells have been trained to attack and kill (cytotoxic) EB virus infected cells.~      We make these cells from the patients blood by first growing an EBV infected B cell line by~     infecting the blood with an EBV virus called B-95. We then treat these EBV infected B cells~     with radiation so they cannot grow and use them to stimulate T cells. This stimulation will~     train the T cells to kill EBV infected cells. We will then test the T cells to make sure they~     kill the EBV infected cells.~      The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn~     what the side effects are, and to see whether this therapy might help prevent or cure EBV~     related cancers in solid organ transplant patients~   "
268173|NCT00058591|"~     Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or~     commonly known as mono or the kissing disease) associated disorder. This disorder may cause~     chronic tiredness and fevers and sometimes be complicated by life threatening problems such~     as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases~     (diseases involving the lymph nodes which could eventually show up as leukemia or a tumor).~     The reasons for the body's inability to control the EBV infection are still unknown and no~     effective treatment is currently available.~      This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We~     want to see if we can grow special white blood cells, called T cells, that have been trained~     to kill EBV infected cells in the laboratory and see if these cells may help control the EBV~     infection when given back to the patient.~      The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn~     what the side effects are, and to see whether this therapy might help the body fight off the~     SCAEBV infection.~   "
268186|NCT00058357|"~     RATIONALE: A lidocaine patch may be effective in relieving numbness, tingling, and other~     symptoms of neuropathy. It is not yet known whether a lidocaine patch is effective in~     treating neuropathy in patients who have undergone surgery for cancer.~      PURPOSE: This randomized phase III trial is studying lidocaine patch to see how well it works~     compared to a placebo patch in relieving numbness, tingling, and other symptoms of neuropathy~     in patients who have undergone surgery for cancer.~   "
268187|NCT00058331|"~     RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients~     with solid tumors. It is not yet known whether epoetin alfa given once a week is more~     effective than epoetin alfa given once every 3 weeks in treating anemia.~      PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating~     anemia in patients who have solid tumors.~   "
268174|NCT00058578|"~     Systemic Sclerosis is a disease that may be caused by the immune system reacting against skin~     and certain organs. It is possible, that by changing the immune system we can modify the~     progression of this disease.~      Stem cells are created in the bone marrow. They mature into different types of blood cells~     that are needed including red blood cells, white blood cells, and platelets. In this study,~     we will stimulate the bone marrow to make extra stem cells. Next we will collect the stem~     cells, select specific cells, and store them. We will then give high dose chemotherapy that~     will destroy the patients immune system. We will then give back the selected stem cells we~     collected. We believe that these selected stem cells may be able to re-create the immune~     system without the portion that causes Systemic Sclerosis.~      The purpose of this study is to try to discover if stem cell transplantation can help~     patients with Systemic Sclerosis. We will also try to learn what the side effects are of this~     treatment in patients with Systemic Sclerosis. We hope that this treatment will help to~     relieve the symptoms patients are experiencing, although we do not know if it will.~   "
268175|NCT00058552|"~     The purpose of this study is to determine if the study drug pertuzumab is effective in~     treating patients with advanced ovarian cancer that is refractory to, or has recurred~     following, prior chemotherapy.~   "
268176|NCT00058539|"~     The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on~     cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer.~   "
268177|NCT00058526|"~     Treatment phase:~      The purpose of this study is to evaluate the safety and the immune response elicited by a new~     anti-cancer therapy in patients with breast cancer in remission but who are at high risk of~     relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2~     protein combined with an immunostimulant called AS15. The study aims to determine the optimal~     of three different dose levels of dHER2 combined with the same fixed dose of AS15 by~     assessing the safety and the immune response elicited after a series of injections of the~     study product.~      Five-year follow-up phase:~      This part of the study aims to assess any late onset toxicity of the study treatment through~     yearly follow-up visits and to monitor the patients' survival and disease status up to five~     years after the last administration of the study treatment. The patients' immune response is~     also measured to assess the robustness of the immune response elicited by the study~     treatment.~   "
268178|NCT00058487|"~     RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop tumor~     cells from dividing so they stop growing or die. Thalidomide may stop the growth of~     hepatocellular (liver) cancer by stopping blood flow to the tumor. Combining epirubicin with~     thalidomide may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with thalidomide~     in treating patients who have unresectable or metastatic liver cancer.~   "
268179|NCT00058474|"~     RATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin~     work in different ways to stop tumor cells from dividing so they stop growing or die.~     Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: This randomized phase III trial is studying radiation therapy and either~     capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well~     they work when given before surgery in treating patients with resectable rectal cancer. It is~     not yet known whether radiation therapy and either capecitabine or fluorouracil is more~     effective with or without oxaliplatin in treating rectal cancer.~   "
268180|NCT00058461|"~     This phase II trial is studying how well rituximab together with ifosfamide, carboplatin, and~     etoposide works in treating young patients with recurrent or refractory non-Hodgkin's~     lymphoma or acute lymphoblastic leukemia. Chemotherapy drugs, such as ifosfamide,~     carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they~     stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     Combining ifosfamide, carboplatin, and etoposide with rituximab may kill more cancer cells.~   "
268181|NCT00058448|"~     RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have~     locally advanced or metastatic penile cancer.~   "
268182|NCT00058435|"~     RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the~     body build an immune response to kill tumor cells.~      PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating~     patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.~   "
268183|NCT00058422|"~     RATIONALE: Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can~     locate cancer cells and either kill them or deliver radioactive cancer-killing substances to~     them without harming normal cells. Drugs used in chemotherapy use different ways to stop~     cancer cells from dividing so they stop growing or die. Combining rituximab and combination~     chemotherapy with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining rituximab and combination~     chemotherapy with yttrium Y 90 ibritumomab tiuxetan in treating older patients who have~     B-cell lymphoma that has not been previously treated.~   "
268184|NCT00058396|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic~     lymphoma.~   "
268185|NCT00058370|"~     RATIONALE: Radioimmunotherapy uses radiolabeled monoclonal antibodies to locate tumor cells~     and deliver radioactive tumor-killing substances to them without harming normal cells.~     Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die. Combining~     intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy may kill~     any tumor cells remaining after surgery.~      PURPOSE: Phase II trial to study the effectiveness of combining intrathecal~     radioimmunotherapy and radiation therapy with combination chemotherapy in treating patients~     who have undergone surgery for medulloblastoma.~   "
268308|NCT00056667|"~     This study will evaluate the relative effectiveness of Relaxation Response (RR) training for~     the treatment of rheumatoid arthritis (RA). The study will compare RR training to RR training~     with cognitive behavioral therapy and to a standard RA education program.~   "
268188|NCT00058318|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine and capecitabine use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining more than one~     chemotherapy drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine~     in treating patients who have advanced renal cell cancer (kidney cancer).~   "
268189|NCT00058305|"~     Phase II trial to study the effectiveness of combining bryostatin 1 with vincristine in~     treating patients who have progressive or relapsed non-Hodgkin's lymphoma after autologous~     bone marrow transplantation or autologous stem cell transplantation. Drugs used in~     chemotherapy such as vincristine use different ways to stop cancer cells from dividing so~     they stop growing or die. Bryostatin 1 may help vincristine kill more cancer cells by making~     the cells more sensitive to the drug~   "
268190|NCT00058292|"~     RATIONALE: Radiolabeled monoclonal antibodies such as yttrium Y90 ibritumomab tiuxetan can~     locate cancer cells and deliver radioactive cancer-killing substances to them without harming~     normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from~     dividing so they stop growing or die. Combining yttrium Y90 ibritumomab tiuxetan and~     chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses~     of chemotherapy drugs and kill more cancer cells.~      PURPOSE: This phase I trial is studying how well giving yttrium Y90 ibritumomab tiuxetan with~     high-dose chemotherapy followed by autologous stem cell transplant work in treating patients~     with relapsed or refractory non-Hodgkin's lymphoma.~   "
268191|NCT00058279|"~     RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the~     immune system and stop tumor cells from growing. Interleukin-2 may stimulate a person's white~     blood cells to kill tumor cells. Combining monoclonal antibody therapy with interleukin-2 may~     kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining monoclonal antibody therapy~     with interleukin-2 in treating patients who have metastatic melanoma.~   "
268192|NCT00058266|"~     RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary~     for cancer cell growth.~      PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with~     localized prostate cancer who are planning to undergo radical prostatectomy.~   "
268193|NCT00058253|"~     This phase I trial is studying the side effects and best dose of combination chemotherapy in~     treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy,~     such as docetaxel and 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may~     kill more tumor cells.~   "
268194|NCT00058240|"~     This phase I/II trial studies the side effects and best dose of flavopiridol in treating~     patients with previously treated chronic lymphocytic leukemia or lymphocytic lymphoma. Drugs~     used in chemotherapy such as flavopiridol work in different ways to stop cancer cells from~     dividing so they stop growing or die.~   "
268195|NCT00058227|"~     This phase I trial studies the side effects, best way to give, and the best dose of alvocidib~     when given together with fludarabine phosphate and rituximab in treating patients with~     previously untreated or relapsed lymphoproliferative disorders or mantle cell lymphoma.~     Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or~     deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy such as alvocidib and fludarabine use different ways to stop cancer cells from~     dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy~     may kill more cancer cells.~   "
268196|NCT00058214|"~     Phase II trial to study the effectiveness of perifosine in treating patients who have~     recurrent prostate cancer. Drugs used in chemotherapy such as perifosine use different ways~     to stop tumor cells from dividing so they stop growing or die~   "
268197|NCT00058201|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which chemotherapy regimen is more effective,~     or whether chemotherapy is more effective than observation, in treating pancreatic cancer~     after surgery.~      PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no~     further therapy in treating patients who have completely resected pancreatic cancer.~   "
268198|NCT00058188|"~     RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation~     therapy. It is not yet known whether zoledronate combined with calcium is more effective than~     calcium alone in preventing bone loss.~      PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with~     calcium with that of calcium alone in preventing bone loss in patients with stage III or~     stage IV prostate cancer who have received long-term androgen deprivation therapy.~   "
268199|NCT00058149|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine and oxaliplatin use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining more than one drug~     and giving them in different ways may kill more tumor cells. It is not yet known whether~     gemcitabine is more effective with or without oxaliplatin in treating pancreatic cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or~     without oxaliplatin in treating patients who have locally advanced or metastatic pancreatic~     cancer.~   "
268200|NCT00058123|"~     RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune~     system and stop tumor cells from growing.~      PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with~     recurrent, progressive, or relapsed anaplastic glioma.~   "
268201|NCT00058097|"~     Phase II trial to study the effectiveness of combining tipifarnib with radiation therapy in~     treating patients who have newly diagnosed glioblastoma multiforme. Tipifarnib may stop the~     growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib with radiation~     therapy may make the tumor cells more sensitive to radiation therapy and may kill more tumor~     cells.~   "
268215|NCT00057915|"~     RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the~     body build an immune response to kill cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with refractory stage IV cancer.~   "
271210|NCT00036036|"~     The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in~     locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461~     in this patient population.~   "
268202|NCT00058084|"~     This randomized phase II trial is studying ixabepilone to see how well it works compared to~     mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not~     responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in~     different ways to stop tumor cells from dividing so they stop growing or die. Some tumors~     become resistant to chemotherapy drugs. Ixabepilone may reduce resistance to the drugs and~     allow the tumor cells to be killed. It is not yet known which chemotherapy regimen is more~     effective in treating metastatic prostate cancer~   "
268203|NCT00058071|"~     RATIONALE: Amifostine may be effective in relieving numbness, tingling, and other symptoms of~     peripheral neuropathy. It is not yet known whether amifostine is effective in treating~     peripheral neuropathy in patients who have received chemotherapy for cancer.~      PURPOSE: This randomized phase III trial is studying amifostine to see how well it works~     compared to observation in relieving numbness, tingling, and other symptoms of peripheral~     neuropathy in patients who have received platinum-based chemotherapy (such as cisplatin or~     carboplatin) for cancer.~   "
268204|NCT00058058|"~     RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the~     ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral~     breast cancer.~      PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected~     breast of women recently diagnosed with unilateral breast cancer.~   "
268205|NCT00058045|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.~     Stem cell factor may increase the number of immune cells found in bone marrow or peripheral~     blood and may help a person's immune system recover from the side effects of cancer therapy.~      PURPOSE: Phase I trial to study the effectiveness of combining interleukin-2 with stem cell~     factor in treating patients who have AIDS or AIDS-related cancer.~   "
268206|NCT00058032|"~     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective~     treatment for cancer. It is not yet known if ultrasound is more effective with or without~     measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.~      PURPOSE: Randomized clinical trial to study the effectiveness of ultrasound with or without~     measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.~   "
268207|NCT00058019|"~     This phase II trial is studying how well ixabepilone works in treating patients with relapsed~     or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as~     ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing~     or die.~   "
268208|NCT00058006|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of celecoxib may be an effective way to prevent~     the recurrence of stage I or stage II head and neck cancer or stage I non-small cell lung~     cancer.~      PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works~     compared to that of a placebo in preventing disease recurrence in patients with stage I or~     stage II head and neck cancer or stage I non-small cell lung cancer.~   "
268209|NCT00057993|"~     RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2~     on their surface and either kill them or deliver tumor-killing substances to them without~     harming normal cells. Estrogen can stimulate the growth of breast cancer cells. Hormone~     therapy using exemestane may fight breast cancer by reducing the production of estrogen.~     Combining trastuzumab with exemestane may be an effective treatment for breast cancer with~     high amounts of HER2.~      PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with exemestane~     in treating postmenopausal women who have metastatic or locally advanced HER2-positive breast~     cancer.~   "
268210|NCT00057980|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining celecoxib with epirubicin may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of epirubicin when~     given together with celecoxib and to see how well it works in treating patients with~     hepatocellular carcinoma (liver cancer).~   "
268211|NCT00057967|"~     RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with~     relapsed or refractory advanced mycosis fungoides or Sézary syndrome.~   "
268212|NCT00057954|"~     RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet (UV)~     light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune~     system and reduce the chance of developing graft-versus-host disease (GVHD) following bone~     marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation~     may be effective in killing cancer cells before bone marrow transplantation.~      PURPOSE: This phase II trial is studying how well giving photophoresis together with~     pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone~     marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's~     lymphoma.~   "
268213|NCT00057941|"~     This randomized phase II trial is studying how well giving gefitinib together with~     anastrozole works compared to giving gefitinib together with fulvestrant in treating~     postmenopausal women with recurrent or metastatic breast cancer. Estrogen can stimulate the~     growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight~     breast cancer by blocking the use of estrogen. Gefitinib (ZD1839) may stop the growth of~     cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether~     gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast~     cancer.~   "
268214|NCT00057928|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether cisplatin is more effective when combined with paclitaxel or gemcitabine in~     treating cervical cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with~     paclitaxel to that of cisplatin combined with gemcitabine in treating women who have~     recurrent, persistent, or metastatic cervical cancer.~   "
268248|NCT00057486|"~     There is no proven effective treatment for chronic diarrhea caused by the parasite~     Cryptosporidium in advanced AIDS. This trial will test the safety of interleukin-12 (IL-12)~     as part of a combination therapy for this parasite.~   "
268216|NCT00057889|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have metastatic renal cell cancer (kidney cancer) that is refractory to~     treatment with interleukin-2 or unable to be treated with interleukin-2.~   "
268217|NCT00057876|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. It is not yet known whether gemcitabine is more effective with or without~     radiation therapy in treating pancreatic cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without~     radiation therapy in treating patients who have locally advanced, unresectable pancreatic~     cancer.~   "
268218|NCT00057863|"~     Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in~     treating patients who have locally recurrent or metastatic cervical cancer. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug may kill more tumor cells.~   "
268219|NCT00057850|"~     Phase I/II trial to study the effectiveness of combining BMS-247550 with cisplatin in~     treating patients who have metastatic or recurrent head and neck cancer. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug may kill more tumor cells.~   "
268220|NCT00057837|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective in treating~     extensive-stage small cell lung cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.~   "
268221|NCT00057811|"~     Phase II trial to study the effectiveness of combining rituximab and rasburicase with~     combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell~     leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they~     stop growing or die. Combining more than one drug with rituximab may kill more cancer cells.~     Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of~     chemotherapy.~   "
268222|NCT00057798|"~     RATIONALE: Determination of genetic changes in patients with non-small cell lung cancer may~     help predict the outcome of treatment. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining more than one drug, and~     giving them before surgery, may shrink the tumor so that it can be removed during surgery.~      PURPOSE: Phase II trial to study genetic changes and the effectiveness of combining~     vinorelbine with gemcitabine before surgery in treating patients who have stage IB, stage II,~     or stage III non-small cell lung cancer.~   "
268223|NCT00057785|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth~     dryness, and may help patients live more comfortably. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy~     techniques with or without chemotherapy in reducing mouth dryness in patients who have~     nasopharyngeal cancer.~   "
268224|NCT00057759|"~     RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for~     prostate cancer to have an erection for sexual activity and may improve sexual satisfaction~     and quality of life.~      PURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating~     erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for~     prostate cancer in clinical trial RTOG-9910.~   "
268225|NCT00057746|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known which radiation therapy regimen is more effective in preventing brain metastases in~     patients with limited-stage small cell lung cancer while taking into account chronic~     neurotoxicity from radiation therapy.~      PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity~     between three different brain irradiation regimens. The corresponding phase III component~     addressing the prevention of brain metastases was run by EORTC and reported separately~     (NCT00005062).~   "
268226|NCT00057733|"~     RATIONALE: Stress management techniques such as muscle relaxation, guided imagery, and~     abdominal breathing may improve quality of life and decrease emotional distress in patients~     who are undergoing radiation therapy for cancer.~      PURPOSE: Randomized clinical trial to determine the effectiveness of stress management~     training in helping cancer patients cope with the emotional distress of radiation therapy.~   "
268227|NCT00030368|"~     Phase I trial to study the effectiveness of combining bortezomib with paclitaxel in treating~     patients who have advanced or metastatic solid tumors. Bortezomib may stop the growth of~     cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy~     work in different ways to stop tumor cells from dividing so they stop growing or die.~     Combining bortezomib with paclitaxel may kill more tumor cells.~   "
268228|NCT00023673|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells~     from dividing so they stop growing or die. Combining more than one drug and giving them with~     specialized radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined~     with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung~     cancer.~   "
268229|NCT00004079|"~     Phase I trial to study the effectiveness of sarcosinamide nitrosourea in treating patients~     who have metastatic or unresectable solid tumors. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die~   "
268230|NCT00057720|"~     The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as~     compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT)~     populations.~   "
268231|NCT00057707|"~     This study will evaluate whether modafinil improves cognition in patients with schizophrenia~     and healthy volunteers. Modafinil is a drug that has been FDA approved for day-time~     sleepiness and allegedly increase the amount of the neurotransmitter dopamine in the frontal~     cortex of the brain~   "
268232|NCT00057694|"~     This study will explore adult adoptees' perceptions of the potential value of genetic and~     family history information. Unlike most people, many adopted individuals do not have access~     to personal or family medical information because of laws and practices that prevent~     disclosure. Research suggests that adopted individuals are interested in obtaining this~     information about their biological families. This study will examine adoptees':~        -  Satisfaction with the amount of genetic information they have, their motivations for~          wanting more information, and when it becomes important for them to have this~          information.~        -  Perceptions of the degree to which they believe genetics and family history influence~          various traits and conditions.~      The study will also explore adoptees' interactions with health care providers so that~     recommendations can be developed for helping genetic counselors meet the needs of these~     individuals.~      English-speaking adoptees 18 years of age and older are eligible for this study. Those~     enrolled will participate in a one-time telephone interview that will take about 45 to 60~     minutes. The interview will obtain demographic information, such as the adoptee's age, sex,~     racial and ethnic background, marital status, and education level, and will include questions~     in the following areas:~        -  Personal adoption story;~        -  Perceptions of the role of the biological family history and medical information and its~          importance and usefulness;~        -  Perceptions of the influence of genetics and family history on health;~        -  Reproductive history and pregnancy concerns related to being adopted;~        -  Experiences and interactions with health care providers related to adoption;~        -  Suggestions for improving interactions with health care providers.~   "
268233|NCT00057681|"~     This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate~     (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar~     disorder or symptoms of mania.~   "
268234|NCT00057668|"~     This study will determine the effectiveness of a combination of treatments in preventing~     behaviors that are typically associated with Attention Deficit Hyperactivity Disorder (ADHD)~     in young children.~   "
268235|NCT00057655|"~     The purpose of this study is to determine whether access to behavioral health services has~     been affected by welfare reform.~   "
268236|NCT00057642|"~     This study will develop an intervention that will increase the retention of Hispanics with~     major depression in antidepressant therapy.~   "
268237|NCT00057629|"~     This study will evaluate the effectiveness of a brief cognitive behavioral therapy,~     administered by community agencies, for the treatment of patients with Post Traumatic Stress~     Disorder (PTSD).~   "
268238|NCT00057616|"~     Subjects are randomized to one of two treatment arms. All subjects are screened for~     eligibility within 28 days prior to randomization. The study consists of a treatment phase~     and a follow-up phase. Subjects are treated in repeating 4 week cycles.~   "
268239|NCT00057603|"~     This study will evaluate the use of Deep Brain Stimulation (DBS) to reduce symptom severity~     and enhance the quality of life for patients with treatment-resistant obsessive compulsive~     disorder (OCD).~   "
268240|NCT00057590|"~     This study will assess the effects of depression treatment on employee productivity. This~     study will also evaluate the impact of depression screening and outreach on employees'~     receptivity to treatment.~   "
268241|NCT00057577|"~     This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant~     medication (ADM) enhances treatment for depression. This study will also test whether the~     addition of CT to ADM will prevent recurrences of depression after therapy is over.~   "
268242|NCT00057564|"~     To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to~     that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects~     with active multiple myeloma~   "
268243|NCT00057551|"~     This 24-week study, with a 12-month follow up period, will compare the effectiveness of~     antidepressant medication alone to the combination of psychotherapy and antidepressant~     medication in patients with chronic depression.~   "
268244|NCT00057538|"~     The purpose of this study is to determine the effectiveness of a stress management group~     intervention for people with HIV. The study will evaluate several outcomes, including~     perceived stress, quality of life, psychosocial factors, and physiological measures of~     stress.~   "
268245|NCT00057525|"~     This study will provide preliminary safety and comparative immunogenicity data for the E.coli~     derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses~     will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with~     phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.~   "
268246|NCT00057512|"~     The purpose of this study will be to determine the safety and tolerability of intratumoral~     M4N. Patients suffering from cancer of the head and neck that is recurrent after primary~     treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is~     a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for~     three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor~     volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4~     weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated~     for 6 weeks, and finally, 8 weeks.~   "
268247|NCT00057499|"~     Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused~     by the destruction of insulin-producing cells in the pancreas. People with T1DM do not~     produce enough insulin, which is necessary for proper regulation of blood sugar levels.~      T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune~     system attacks the body itself. In addition to regulating blood sugar, insulin may have the~     ability to protect cells in the pancreas from attack by the immune system. This study will~     evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction.~      Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or~     slowing of the ongoing autoimmunity, and this will result in an appreciable difference in~     functioning B cell mass compared to the placebo treated group by the end of the study.~   "
268250|NCT00057447|"~     Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b~     (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with~     progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL)~      International study with sites in the Czech Republic and Poland~   "
268251|NCT00057434|"~     The study will determine whether a daily vitamin and mineral supplement (a multivitamin~     including Vitamin A) will improve health when added to standard chemotherapy for~     tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected~     and HIV uninfected patients.~   "
268252|NCT00057421|"~     This was a clinical trial in HIV infected patients with tuberculosis. The study assessed~     whether the addition of prednisolone, a type of steroid medication, to the standard treatment~     for tuberculosis improved immune and viral outcomes in the patients. The study demonstrated~     that prednisolone increased the CD4 cell count as was hoped, but the beneficial effect was~     short-lived and was gone within 4 months of stopping therapy. Therefore, the use of~     prednisolone for tuberculosis in HIV infected patients is not recommended at this time.~   "
268253|NCT00057460|"~     This study will use transcranial magnetic stimulation (TMS) and electroencephalography (EEG)~     to test the safety of an experimental anti-epileptic drug called Talampanel and learn how it~     affects brain activity. Talampanel blocks a type of brain receptor called AMPA; inhibiting~     this receptor may result in anti-seizure activity.~      TMS stimulates the outer part of the brain, called the cortex. For this procedure, an~     insulated wire coil is placed on the subject's scalp. A brief electrical current is passed~     through the coil, creating a magnetic pulse that stimulates the brain. This may cause a~     pulling sensation on the skin under the coil and muscle twitching in the face, arm, or leg.~      EEG records the electrical activity of the brain, in the form of brain waves. For this~     procedure, electrodes (metal discs with a conductive gel) attached to wires are affixed to~     the scalp with a paste and the brain activity is recorded.~      Healthy normal volunteers between 18 and 45 years of age may participate in this study.~     Candidates will be screened with a physical and neurological examination, electrocardiogram~     (EKG), blood tests, and blood pressure measurement. Women who are pregnant or nursing are~     excluded from the study.~      Participants will come to the NIH Clinical Center for three testing sessions, at least 1 week~     apart, and a final follow-up visit. The procedure for each test session is as follows:~      7 AM - Blood pressure is measured, EKG and EEC leads are placed, a heparin lock is inserted,~     and a blood sample is drawn. The heparin lock is a thin needle enclosed in a thin plastic~     tube. The needle guides the tube into a vein and is then removed, leaving the tube in place.~     The indwelling tube allows multiple blood samples to be drawn without repeated needle sticks.~      8 - 9 AM - TMS followed by EEG recording.~      9 AM - Administration of Talampanel or placebo (pill with no active ingredient) by mouth.~      10 AM - Blood sample #2.~      10 AM -11 AM - TMS, followed by EEG recording every 5 minutes.~      11 AM - Blood sample #3.~      12 PM - Blood sample #4.~      11 AM - 1 PM - EEG recording every 5 minutes/~      4 PM - Blood sample #5.~      5 PM - Discharge from Clinical Center.~      At the final follow-up visit, the participant will talk with the doctor and have one final~     blood draw.~   "
268254|NCT00057408|"~     This is a 12-week study which investigates the use of olanzapine to decrease disruptive~     behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six~     weeks of the study are double-blind and placebo controlled, meaning that patients receive~     either placebo or olanzapine, and that neither the researchers nor the patients know whether~     or not they are receiving placebo or olanzapine. In the second six weeks all of the patients~     receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know~     how effective the drug is or whether or not the drug causes side effects. Patients treated~     with placebo can have improvement and can have side effects. In the study patients receive a~     psychiatric evaluation, physical examination, laboratory tests, and study medication~     (olanzapine or placebo), free of charge.~   "
268255|NCT00057395|"~     To determine the rate of response and the duration of the response following therapy with~     Aroplatinin patients with advanced solid malignancies.~   "
268256|NCT00057382|"~     This is an international, multicenter, randomized study of intravenous T138067 versus~     intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have~     been treated before with chemotherapy and surgery is not recommended for their cancer. A~     total of 750 subjects will be enrolled in this study.~   "
268257|NCT00057369|"~     This is a study to evaluate a new medication dosed once a week in the treatment of bacterial~     infections in the blood from intravenous catheters (CR-BSI). The primary objective is to~     evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI~     relative to a standard of care treatment, vancomycin.~   "
268258|NCT00057356|"~     This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine~     the effects of conivaptan in patients with acute decompensated heart failure.~   "
268259|NCT00057343|"~     The purpose of this study is to provide treatment for patients who have relapsed NHL or~     refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan~     regimens or Rituxan therapy alone on your disease.~   "
268260|NCT00057330|"~     The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes~     disease in women who are not infected. The study will enroll approximately 7550 healthy~     women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine~     (experimental group) or hepatitis A vaccine (control group). Participants will receive their~     assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and~     additional unscheduled visits for an evaluation of herpes if it is suspected. Participants~     will be involved in study related procedures for up to 20 months.~   "
268261|NCT00057317|"~     The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to~     placebo, are efficacious, safe and tolerable in improving glycemic control in patients with~     type 2 diabetes. Doses of 5 to 20 mg/day will be studied.~   "
268262|NCT00057304|"~     The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to~     placebo, are efficacious, safe and tolerable in improving glycemic control in patients with~     type 2 diabetes. Doses of 2 to 5 mg/day will be studied.~   "
268263|NCT00057291|"~     This study evaluates the effect on children and caregivers of providing training in warm,~     sensitive, responsive caregiving to caregivers in three orphanages in St. Petersburg, Russia.~     The study also assesses the effectiveness of having more consistent care from fewer~     caregivers in a family-like environment.~   "
268264|NCT00057031|"~     The purpose of this study is to determine the safety and efficacy of DN-101 (calcitriol) in~     patients with myelodysplastic syndrome who are dependent on repeat blood transfusions.~   "
268265|NCT00057278|"~     This study will assess the safety and effectiveness of the drug gabapentin in reducing pain~     associated with primary fibromyalgia.~   "
268266|NCT00057265|"~     This study is being conducted to compare the safety and effectiveness of the investigational~     medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European~     and Asian Health Authorities for the treatment of hepatitis B infection. The results for~     patients taking LdT will be compared to results for patients taking Lamivudine.~   "
268267|NCT00057200|"~     Congestive heart failure (CHF) is one of the most common reasons for hospitalization in~     patients aged 65 years and older. Many hospitalizations for CHF are potentially preventable~     if the warning signs of decompensation are recognized and treated before the situation~     becomes emergent. Home-based intervention programs have reduced unplanned readmission rates~     for patients with CHF by up to 50 percent. Using advanced telecommunications technologies it~     is now possible to provide greatly improved access and availability of services in a more~     timely and cost effective manner directly to patients� homes. Although telehealth offers a~     number of theoretical advantages, few empirical studies have compared telehealth to~     traditional delivery modes, and virtually no studies have compared the effectiveness of~     alternative telehealth applications.~   "
268268|NCT00057187|"~     Although substance abuse treatment continuing care participation is strongly related to~     positive treatment outcomes, participation rates are low and few interventions have been~     developed that improve continuing care adherence and outcome.~   "
268269|NCT00057252|"~     This study will develop and evaluate new techniques for computer-aided detection and~     diagnosis (CAD) of medical problems using images from diagnostic tests such as computed~     tomography (CT), ultrasound, nuclear medicine and x-ray images. The Food and Drug~     Administration has approved CAD techniques for detecting masses and calcifications on~     mammography and lung nodules using chest x-rays. Many other applications of CAD would~     potentially benefit patients. This study will explore additional uses of CAD.~      The study will use imaging data, demographic information, and other medical information from~     the medical charts of Clinical Center patients to test and evaluate new CAD applications.~     Such applications include detection of subcutaneous (under the skin) lesions in melanoma~     patients, bone lesions in patients with advanced cancer, and pulmonary emboli (blood clot~     lodged in a lung artery) in patients who are known to have pulmonary emboli, and other uses.~   "
268270|NCT00057239|"~     A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine in~     Patients with Major Depressive Disorder (MDD)~   "
268271|NCT00057226|"~     A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in~     Patients with Major Depressive Disorder (MDD)~   "
268272|NCT00057213|"~     A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in~     Patients with Major Depressive Disorder (MDD)~   "
268273|NCT00057174|"~     This is a series of two prospective studies based on the Department of Veterans Affairs drug~     treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our~     hypothesis is that novel strategies for medical management of gastroesophageal reflux disease~     (GERD) can decrease resource utilization without adversely affecting patient quality of life.~     The strategies tested in this project included 1) step-down management, whereby patients~     rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive~     medication, and 2) intermittent therapy, defined as administration of medication only for~     recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI~     administration since in addition to the VA guideline requiring step-down therapy,~     over-the-counter PPIs administered by intermittent therapy became available for use by~     patients during the study period.~   "
268274|NCT00057161|"~     Money management is a neglected issue in maintaining persons with mental illness in the~     community. This randomized controlled trial (RCT) assessed whether a community-based~     representative payee program, i.e., money management of Social Security and/or VA benefits,~     coordinated with VA psychiatric care (CO-RP) could be more effective than customary treatment~     for veterans who had no representative payee.~   "
268275|NCT00057148|"~     Postoperative pain is often undertreated. Although studies have demonstrated that many~     patients experience a substantial degree of unrelieved pain following operative procedures~     and that this pain can increase the incidence of serious complications, the management of~     discomfort continues to be suboptimal. Narcotic analgesia is the mainstay of acute~     postoperative pain management but patient, clinician, and institutional barriers often limit~     the effectiveness of drug treatment. Furthermore, pharmacologic interventions alone may not~     address all the factors involved in the conscious experience of pain. Massage is a~     complementary or adjunctive medical technique that has been used for thousands of years. Yet~     there is scant research related to the use of massage therapy in postoperative pain~     management. Used in tandem with pharmacologic treatments, massage may have the potential to~     substantially improve acute pain relief.~   "
268276|NCT00057135|"~     This is a randomized controlled trial examining the effectiveness of a pharmacy-based~     intervention designed to improve adherence with antipsychotic medications among patients with~     serious mental illness.~   "
268277|NCT00057122|"~     This study compares three different tuberculosis (TB) prevention regimens against the~     standard regimen of 6 months of isoniazid. It is being conducted in Soweto, South Africa.~     People who are HIV positive and have a positive tuberculin skin test without signs of active~     tuberculosis may join.~   "
268278|NCT00057109|"~     We have previously shown that: 1) time tradeoff utilities for current health are high,~     indicating that patients have a strong will to live; 2) half of patients felt that their life~     was better now than before they were HIV-infected; and 3) certain non-health-related factors~     such as spirituality and concern and love for one�s children correlated with health values~     and a sense that life has improved.~   "
268279|NCT00057096|"~     Veterans presenting for treatment of substance use disorders (SUDs) often have multiple and~     serious comorbid medical conditions that affect functional health status and health care~     costs. Prior studies show higher rates of medical follow-up when onsite primary health care~     was provided to patients with SUDs within an addictions clinic (onsite care). However, no~     data are available on differences between onsite versus referral models of primary care~     delivery in terms of clinical outcomes and total health care costs.~   "
268280|NCT00057083|"~     The purpose of this study is to determine whether the physical separation between patient and~     physician required during telemedicine has an affect on physician-patient communication and~     related outcomes, including patient and physician satisfaction, patient compliance, and~     patient understanding of medical care.~   "
268309|NCT00056654|"~     The primary purpose of the study is to determine if a new sustained-release 45 mg (depot)~     formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them~     at medically castrate levels in subjects with prostatic adenocarcinoma.~   "
268281|NCT00057070|"~     The adverse impact of tobacco use on disease prevalence and health care costs is well~     documented. Hence, finding effective ways to reduce tobacco dependence is an essential~     component of improving the outcomes, quality and efficiency of VHA care. The U.S. Public~     Health Service (PHS) Smoking Cessation Clinical Practice Guideline provides specific~     recommendations for treating tobacco dependence. Despite their strong evidence base, however,~     these recommendations have not been fully integrated into clinical practice within the VHA.~     Recent data suggest that logistical difficulties associated with identifying and linking~     smokers with appropriate treatments may explain why the PHS Smoking Cessation Guideline has~     not been more broadly implemented.~   "
268282|NCT00057057|"~     In addition to medical treatment for heart failure (HF), a variety of non-pharmacological~     interventions have been demonstrated to benefit these patients. Some of these include systems~     for weight monitoring and medication reminders, exercise programs, and individually tailored~     evaluation and treatment plans with dietitians, social workers, psychologists, and nurse case~     managers. While many of these approaches have been shown to increase adherence to medication~     guidelines and result in decreased health care utilization, most rely heavily on a large team~     of specialized health care providers. It remains unknown whether or not an intervention with~     a lower intensity of specialized care using sophisticated automated computer tracking and~     Interactive Voice Response (IVR) techniques can impact the care of HF patients.~   "
268283|NCT00057044|"~     The overall purpose of this project is to improve the clinical outcomes of veterans with~     ischemic heart disease (IHD) through implementation of evidence-based lipid management, with~     a particular focus on veterans whose primary lipid abnormality is a low level of~     HDL-cholesterol (the �good� cholesterol).~   "
268284|NCT00057018|"~     An individual suffering a stroke or other brain injury may lose function on one side of the~     body (partial paralysis). As the individual shifts activities to favor the unaffected side,~     the problem worsens. Constraint induced (CI) therapy forces the individual to use the~     neglected arm by restraining the good arm in a sling. This study examines the effectiveness~     of CI therapy for improving arm motion after stroke.~   "
268285|NCT00057005|"~     Participants in this study have a hematologic malignancy which is a disorder in the bone~     marrow that affects the body's ability to create blood. Participants might benefit from~     receiving an allogeneic stem cell transplant (meaning the cells come from a donor). The~     participants donor is a family member. Stem cells are cells in the bone marrow and blood that~     can form a whole new blood system.~   "
268286|NCT00056992|"~     Amino acid deprivation therapy is an effective means for the treatment of some forms of~     cancer. Recently it has been found that human hepatocellular carcinomas (HCC) cell lines~     appear to require arginine for growth. Arginine is not an essential amino acid for human~     adults or infants as it can be synthesized from citrulline (for review see Rogers 1994).~     Therefore, selective elimination of arginine from the circulation may be a means of treating~     patients with metastatic melanoma or non resectable HCC.~      The enzyme arginine deiminase (ADI) metabolizes arginine into citrulline (Cunin 1986).~     However, ADI is only found in microbes and not in humans. ADI is therefore, highly~     immunogenic and has a short serum half-life following injection. These potential drawbacks~     (microbial source and thus viewed as foreign by the human immune system, and a short serum~     half-life) can be overcome by covalent attachment of polyethylene glycol (PEG) to~     argininedeiminase and termed this drug ADI-PEG 20.~      ADI-PEG 20 appears to be an effective anti-cancer treatment for human HCC. Pharmacokinetic~     and pharmacodynamic data indicates a once a week injection of 160 IU/m2 of ADI-PEG 20~     eliminates all detectable arginine from the circulation for at least 7 days. This treatment~     appears to be well tolerated. The purpose of this study is to determine the efficacy of this~     treatment in patients with HCC. Efficacy is a primary end point of this study. No patients~     will recieve placebo.~   "
268287|NCT00056979|"~     This study treats patients with an inherited disease that prevents the body from making a~     specific protein or enzyme needed for the body's metabolism. Lack of this enzyme causes~     accumulation of harmful or toxic substances in the body, which leads to deterioration and~     failure of organs such as the brain or the heart. This disease can be fatal.~      Some patients with inherited metabolic storage disease may benefit from an allogeneic stem~     cell transplant ('allogeneic' means that the stem cells come from another person). Stem cells~     are created in the bone marrow. They mature into different types of blood cells that are~     needed including red blood cells, white blood cells, and platelets. Stem cells, when~     transplanted, can make a new blood system. Donor stem cells can make the protein or enzyme~     patients with this disease cells cannot. The donor cells may prevent further accumulation of~     toxic substances. It is hoped that the donor cells can prevent or stop the disease from~     progressing.~      This research study uses a new pre-treatment combination of two drugs, Anti-CD45 and~     CAMPATH-1H. Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells.~     CAMPATH-1H is particularly important because it stays active in the body for a long time~     after infusion, which means it may work longer at preventing GVHD symptoms. In addition to~     antibodies, patients will receive Fludarabine, which is a chemotherapy drug. Fludarabine~     kills bone marrow cells and is given to reduce the bone marrow cells so that donor stem cells~     may 'take.'~   "
268303|NCT00056771|"~     This study will explore the clinical and hereditary (genetic) features of inherited~     cataracts. A cataract is a clouding of the eye lens, which focuses light on the back of the~     eye. When the lens becomes cloudy and does not let light through, vision is impaired.~     Cataracts may be associated with vision problems alone, or with other problems, such as~     changes in facial appearance or skin problems. A better understanding of these genetic~     conditions may help in the development of better diagnostic tests.~      Patients with inherited cataracts and their family members may be eligible for this study.~     Participants will be drawn from patients enrolled in other studies of inherited cataracts at~     the NEI and collaborating clinics.~      Participants will undergo the following tests and procedures:~        -  Medical and surgical history;~        -  Verification of diagnosis;~        -  Construction of a family tree regarding familial vision problems;~        -  Complete eye examination, including dilation of the pupils and photography of the lens,~          tests of color vision and field of vision, and of the ability to see in the dark;~        -  Blood sample collection (20 ml, or 4 teaspoons) for genetic studies of hereditary~          cataracts.~   "
271221|NCT00035880|"~     Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus~     ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does~     not respond to steroid therapy.~   "
268288|NCT00056966|"~     Participants in this study have a hematologic malignancy (a disorder in the bone marrow that~     affects the body's ability to create blood) that might benefit from receiving an allogeneic~     stem cell transplant (meaning the cells come from a donor) from a family member or nearly~     identical matched donor. The donor may either be a matched sibling, a mismatched family~     member, or an unrelated person.~      Usually these patients are given high doses of chemotherapy before receiving a stem cell~     transplant to keep their immune system from rejecting the donor stem cells and to kill any~     diseased cells that remain in the body. However, this group of patients have a high risk of~     developing possibly life-threatening treatment-related side effects such as infections,~     damage to vital organs such as lungs, liver, kidney and heart, as well as graft versus host~     disease (GVHD).~      Instead of the high dose chemotherapy and radiotherapy usually given before a transplant,~     this research study uses a new pre-transplant combination of three drugs, Fludarabine,~     Anti-CD45 and CAMPATH-1H with low dose radiotherapy. Fludarabine is a chemotherapy drug while~     Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells, including those~     which are causing this disease. CAMPATH-1H is particularly important because it stays active~     in the body for a long time after it is given, which means it may work longer to prevent GVHD~     symptoms. Anti-CD45 may help in eradicating residual malignant cells. All these agents also~     help in preventing rejection of donor stem cells. This study is designed to give a less~     intense chemotherapy and radiotherapy, so that the life-threatening toxicities of~     conventional high dose chemotherapy and radiotherapy regimen can be reduced, while~     maintaining the ability to cure cancer.~   "
268289|NCT00056953|"~     This study will evaluate the effectiveness of a peer mentoring program designed for youths~     ages 9 to 15 whose parents or guardians are HIV infected. The program will focus on the~     youths' mental health, school performance, alcohol and drug use, personal and social~     behaviors, and behaviors that might expose them to HIV. The study is expected to enroll~     predominantly minority youth.~   "
268290|NCT00056940|"~     Violence is one of the major causes of death and injury for children, adolescents, and young~     adults 10 to 25 years of age. This study will examine the effectiveness of a violence~     prevention program in pediatricians’ offices. The program is designed for families who bring~     their 2 to 11 year old children in for a well child exam. It focuses on helping parents~     change behaviors related to the development of violent behavior in children.~   "
268291|NCT00056927|"~     The purpose of this study is to determine whether an anti-smoking program for parents who~     smoke will lower the odds that their children will start smoking. The study will evaluate an~     activity-based program for parents and their children. The program is home-based and uses the~     mail for program delivery.~   "
268292|NCT00056875|"~     This is a single arm dose escalation study of recombinant human keratinocyte growth factor~     given to patients undergoing allogeneic bone marrow transplantation who are at high risk for~     graft versus host disease (GVHD).~   "
268293|NCT00056914|"~     This study will develop new techniques for optimizing resolution in magnetic resonance~     imaging (MRI) with a high magnetic field of 7 Tesla. MRI is a diagnostic tool that generates~     high-quality images of the body without the use of x-rays. It can also provide information~     about brain chemistry and physiology. The test is routinely done at magnetic field strengths~     of from 1.5 to 4 Tesla. This study will use an investigational device that operates at a high~     magnetic field of 7 Tesla. Except for the increase in magnetic field, all other aspects of~     imaging are the same as those at lower magnetic fields. This study will use techniques in~     conjunction with the higher magnetic field that may improve diagnostic imaging. The MRI will~     monitor the brain at high resolution to see structural features, to measure brain chemicals,~     and to determine how much and how fast blood flows into brain regions in response to simple~     tasks.~      Healthy normal volunteers 18 years of age and older may participate in this study. Candidates~     will be screened with a medical history, neurological examination, and questionnaire.~      Participants will have a standard 1.5 or 3 Tesla MRI before the 7 Tesla scan, adding about 5~     minutes to the procedure. The procedure for both scans is the same. The subject lies on a~     table that is moved into the scanner. Because the machine makes loud sounds during the~     imaging, earplugs are provided to help reduce the noise. An insulated wire coil may be placed~     around the subject's head to obtain better images. Scanning time varies from 20 minutes to 3~     hours, with most examinations lasting between 45 and 90 minutes. During the scan, the subject~     may be asked to perform simple tasks, such as listening to tones, tapping fingers, moving a~     hand, watching a movie on a screen, or smelling pleasant odors. More complex tasks may~     require thinking about tones or pictures and responding to them by pressing buttons.~     Following the test, subjects will complete a brief questionnaire about comfort level and any~     unusual sensations they may have experienced during the test.~      Participants who undergo repeated MRIs for the evaluation of new techniques will have a~     standard 1.5 or 3 Tesla MRI brain study once a year while participating in the research~     protocol. A radiologist at NIH will read the MRIs, and if any abnormalities are discovered,~     the individual will be referred to his or her private physician or to a consult service at~     NIH.~   "
268294|NCT00056901|"~     This study evaluates the relationship between mood changes and hormones in women with~     postpartum depression (PPD).~      This is an observational study; volunteers who participate will not receive any new or~     experimental therapies.~      PPD is similar to major depression, but develops around the time a woman gives birth. Women~     with PPD often suffer serious physical and emotional impairments. Controversy exists~     regarding the role of hormone changes in postpartum depression. This study will examine the~     role of hormone changes in three groups of women: those who recently gave birth and have mild~     to moderately severe PDD (Group 1), women who recently gave birth and do not have PDD (Group~     2), and those who are currently pregnant and experienced an episode of PDD with a previous~     birth (Group 3).~      Participants will be screened with a medical history, physical examination, and blood and~     urine tests. Upon study entry, they will be interviewed about their moods, behaviors, and~     medical status during and immediately following their last pregnancy. Some women will be~     asked to participate in interviews, psychological tests, and blood tests. They will also~     complete self-rating scales and may be asked to collect samples of their urine. Women in~     Group 3 will complete self-rating scales for 6 months postpartum. Participants will~     participate in genetic studies that involve completing a questionnaire and providing a blood~     sample. If the participant allows, sisters and parents may be asked to provide a blood sample~     and undergo a psychiatric interview.~      Participants who meet the criteria for minor depression or major depression that is no~     greater than moderate severity will be asked to participate in a companion study that will~     evaluate the effectiveness of estradiol in reducing depression symptoms.~   "
268304|NCT00056758|"~     This study will evaluate the safety of and immune responses to a dendritic cell vaccination~     for HIV-1 infection. The vaccine will be made from a patient's own cells combined with small~     fragments of HIV-1 (made synthetically in a laboratory). These cells will be administered~     back to the patient either into a vein (intravenously) or the skin (subcutaneously).~   "
271222|NCT00035867|"~     The purpose of this study is to determine the safety and efficacy of TLK199 in patients with~     myelodysplastic syndrome (MDS).~   "
268295|NCT00056888|"~     This study will use three neurophysiological tests (see below) to determine what areas of the~     brain are responsible for paroxysmal hyperkinetic movement disorders. Patients with these~     disorders have sudden, brief attacks of movement, similar to epileptic seizures, but without~     loss of consciousness.~      Normal volunteers and patients with two subtypes of paroxysmal hyperkinetic movement~     disorder, paroxysmal dyskinesia and psychogenic variant, that can be induced by a specific~     trigger, such as a sudden movement or prolonged exercise, will be included in this study.~     Candidates must be 12 years of age or older. Women of childbearing potential will be screened~     with a pregnancy test.~      Participants will undergo one or more of the procedures detailed below. Patients' test~     results will be compared with those of normal volunteers. Before each test, participants will~     provide a medical history and undergo a brief physical examination. During each procedure,~     the subject will have surface electromyography (EMG) to measure the electrical activity of~     muscles. For EMG, electrodes (metal discs) filled with a conductive gel are taped to the skin~     over the muscle to be evaluated.~      Functional Magnetic Resonance Imaging (fMRI)~      MRI uses a strong magnetic field, radio waves, and computer technology to provide detailed~     images of the brain. For this test, the subject lies in a narrow cylinder (the scanner),~     while pictures of the brain are taken. Earplugs are worn to muffle loud noises caused by~     electrical switching of radio frequency circuits used in the scanning process. For functional~     MRI (fMRI), the subject is asked to mimic a movement that occurs during an attack, such as~     stiffening the hand to make a fist or flexing and rotating the arm inward, to detect changes~     in the brain regions involved in the movement. During the procedure, involuntary movements~     and voluntary movements will be monitored by surface EMG and by video camera. The test will~     last about 1-1/2 hours.~      Electroencephalography (EEG)~      EEG measures the electrical activity of the brain (brain waves) with electrodes placed on the~     scalp. During the procedure, muscle activity will be recorded with EMG. The subject will~     first relax and then will be asked to mimic a movement attack. The test will last from 1-1/2~     to 2 hours.~      Startle Reflex~      The subject will put on a headphone and hear loud noises in a random fashion. During the~     test, muscle activity will be recorded with EMG and with a video c...~   "
268296|NCT00056836|"~     The purpose of this study is to determine whether injections of rhuFab V2 into the eye can~     prevent vision loss in patients with age-related macular degeneration, and also to evaluate~     the safety of this treatment.~   "
268297|NCT00056823|"~     The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in~     combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment~     for patients with age-related macular degeneration.~   "
268298|NCT00056862|"~     This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for~     certain patients with chronic hepatitis C-a liver disease that, in some patients, can~     progress to cirrhosis of the liver, liver cancer, and liver failure.~   "
268299|NCT00056849|"~     This study will explore how genes-units of heredity-may influence the severity of ankylosing~     spondylitis. It will examine whether some genes may cause people with ankylosing spondylitis~     to have more rapid fusion of the bones of the spine, more difficulty performing daily~     activities, or be more likely to need joint surgery.~      Patients who developed ankylosing spondylitis after age 16 and have had the disease for 20~     years or more may be eligible for this study. The onset of disease is dated to the first~     appearance of symptoms of inflammatory low back pain or restricted spinal motion. Patients~     with a spondyloarthropathy other than AS may not enroll.~      Participants will complete a brief medical history and physical exam. They will fill out a~     30-minute questionnaire that includes questions on demographics (such as age, ethnicity,~     marital status, etc.), medication history, work history, hip surgeries, and assessment of~     functional disability. Fifty milliliters (about 3-1/3 tablespoons) of blood will be drawn for~     gene testing, and X-rays will be taken of the pelvis, lower back, and neck, if recent X-rays~     (within 1 year) are not available. Women of childbearing age will have a urine pregnancy test~     before having X-rays.~   "
268300|NCT00056810|"~     In developed countries, Guillain-Barre Syndrome (GBS) is the most common cause of acute~     neuromuscular paralysis, afflicting about 5,000 persons annually in the United States. Over~     20% of GBS patients have permanent residual motor deficits that affect their activities of~     daily living.~      The goal of this study is to assess the potential usefulness and safety of 4-aminopyridine~     (4-AP) in those patients who suffer chronic functional deficits from GBS.This medication is a~     potassium channel blocker that has the potential to improve nerve conduction, particularly~     across partially demyelinated axons. It is felt that by increasing nerve conduction there~     will be improved motor performance for walking and activities of daily living, as well as~     decreased fatiguability. This medication has demonstrated potential usefulness in central~     demyelinating diseases such as multiple sclerosis.Because the peripheral nervous system is~     much more accessible to systemic medication delivery it is felt that this medication may~     improve the functional status of those patients who are suffering from the residual side~     effects of this medication.~   "
268301|NCT00056797|"~     This study will evaluate whether the HIV vaccine ALVAC vCP1452 given in combination with~     interleukin-2 (IL-2), also known as aldesleukin, can increase immune system function in~     people with HIV infection.~   "
268302|NCT00056784|"~     This study will examine whether measurements of connective tissue growth factor (CTGF) and~     other cell proteins can identify which kidney transplant recipients are likely to develop~     chronic allograft nephropathy (CAN), a disease of the transplanted kidney. CAN may occur~     months to years after the transplant. The kidney becomes progressively scarred and eventually~     loses all function, so that dialysis or another transplant is needed. A better understanding~     of how CTGF and other proteins are involved in the development of CAN may provide new targets~     for treating for the disease.~      Patients who are scheduled to receive a kidney or combined kidney-pancreas transplant or who~     have received a transplant recently (within 6 months) may be eligible for this study.~     Participants will be enrolled before the transplant, if possible, or after the transplant,~     and will undergo the following tests and procedures:~        -  Physical examinations at the screening visit, at 1, 6, 12, and 24 months, and then once~          yearly.~        -  Blood sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then~          once yearly.~        -  Urine sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then~          once yearly.~        -  Kidney biopsies at the beginning of the study, at 1, 6, 12, and 24 months, and then once~          a year for research purposes. Participants may refuse to have a research biopsy at any~          time during the study. Also, patients who are having a kidney biopsy for another reason~          at these time points will not have a second biopsy. The biopsy procedure takes about 15~          minutes and is done in the hospital. The patient lies on his or her back and the skin~          over the transplanted kidney is cleaned with alcohol and iodine. The area is numbed with~          an injection of an anesthetic, and then a biopsy needle is placed through the kin. The~          biopsy may be repeated up to three times to get enough tissue to test for CAN. Patients~          lie flat for 4 hours after the procedure to reduce the risk of bleeding, and are~          observed for another 2 hours for possible complications.~   "
268305|NCT00056745|"~     The purpose of this study is to determine the safety and immune system response to the TBC-3B~     HIV vaccine when it is injected either into the groin area or into the arm. The goal is to~     determine which injection site is better at producing a particular type of immune response.~     This study is not evaluating the effectiveness of the vaccine, so volunteers must maintain~     low risk behavior for HIV transmission throughout the study.~   "
268306|NCT00056693|"~     To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.~   "
268307|NCT00056680|"~     This study evaluated the efficacy of a comprehensive, three-part program for parents of~     premature infants. This program was designed to improve development in preterm children and~     includes an educational video, tests to evaluate the child's strengths and abilities, and~     instruction in infant massage.~   "
268310|NCT00056641|"~     This is an open-label, randomized, parallel group pharmacokinetics trial of~     tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV),~     amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple~     antiretroviral (ARV) experienced HIV-1 patients.~      The primary objective is to determine the safety and pharmacokinetics of:~      TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination~     with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).~   "
268311|NCT00056719|"~     This study will explore how genes may influence the severity of ankylosing spondylitis, a~     form of arthritis that affects the spine. Patients have inflammation of the joints of the~     spine, which may cause the bones of the spine to fuse, resulting in difficulty performing~     daily activities.~      Patients who developed ankylosing spondylitis after age 16 may be eligible for this study.~     The onset of disease is dated to the first appearance of symptoms of inflammatory low back~     pain or restricted spinal motion. Patients with a spondyloarthropathy other than AS may not~     participate. Candidates will be screened with a medical history and physical examination,~     blood test, and review of their medical records. They will also complete a questionnaire~     about their disease symptoms and medical history.~      Those enrolled in the study will return to the NIH Clinical Center at 6, 12, 18, 24, 30, 36,~     42, 48, 54, and 60 months after screening for examination of the joints, measurement of~     flexibility of the spine, and a blood test. They will also complete symptoms assessment and~     coping questionnaires. At the first study visit (screening visit), x-rays will be taken of~     the pelvis, lower back, and neck, if recent X-rays (within 1 year) are not available. These~     x-ray studies will be repeated on all patients every two years during the study (at 24 and 48~     months after screening).~   "
268312|NCT00056706|"~     This study will determine whether impaired hand function due to stroke can be improved by~     blocking nerve impulses to the unaffected arm. Following a stroke, the unaffected side of the~     brain might negatively influence the affected side. Studies in healthy volunteers show that~     function in one hand improves when ischemic nerve block (inflating a pressure cuff to block~     nerve impulses) is applied to the forearm of the other hand. This study will examine whether~     similar improvement also occurs in the affected hand of patients with chronic impairment~     after stroke.~      Stroke patients with sensory (numbness) or motor impairment (weakness) in the hand that has~     persisted at least 12 months after the stroke may be eligible for this study. Patients who~     have had more than one stroke, whose stroke affected both sides of the body, who have a~     history of deep vein thrombosis (blood clotting), or who are receiving anticoagulant~     (blood-thinning) treatment at the time of the study will not be enrolled.~      Participants will have physical and neurological examinations and will undergo the following~     procedures:~      Session 1~        -  Magnetic resonance imaging (if one has not been done within the previous 6 months): MRI~          uses a magnetic field and radio waves to produce images of body tissues and organs. For~          this procedure, the patient lies on a table that is moved into the scanner (a narrow~          cylinder) and wears earplugs to muffle loud knocking and thumping sounds that occur~          during the scanning process. The procedure lasts about 45 to 90 minutes, during which~          the patient lies still up to a few minutes at a time.~        -  Mini Mental State Examination - Patients will take a short test to assess cognitive~          function.~      Sessions 2 (and possibly 3 and 4)~        -  Motor task practice: Patients practice a motor task several times to achieve optimal~          performance. The task is a rhythmic, repetitive pinch grip at maximal strength at a~          frequency of one grip every 10 seconds. If technical difficulties arise during the~          session, the procedure will be repeated in sessions 3 and 4.~      Sessions 5 (and possibly 6)~        -  Pinch grip and ischemic nerve block (INB): Patients perform the pinch grip task several~          times and then INB is applied. For INB, a blood pressure cuff is inflated around the arm~          at the level of the elbow for 35 to 50 minutes. The procedure causes temporary numbness,~          tingling, loss of muscle strength, and discoloration or the forearm and hand. Patients~          repeat the pinch grip task during the INB and again 20 minutes after the INB is~          released. If technical difficulties arise during the session, the procedure will be~          repeated in session 6.~      Session 7~      This session is identical to session 5, except the INB is applied immediately above the ankle~     instead of on the forearm.~   "
268313|NCT00056628|"~     This is a study of the effect on the progression of Alzheimer's Disease of a surgically~     implanted shunt (tube) to increase the flow of cerebrospinal fluid and improve the clearance~     of potential neurotoxins from the fluid bathing the brain.~   "
268314|NCT00056589|"~     This trial was conducted in the United States of America (USA). The aim of this trial was to~     investigate safety and pharmacokinetics of escalating single doses of catridecacog~     (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.~   "
268315|NCT00056602|"~     This study will explore how patients with rheumatoid arthritis evaluate, or rate, symptom~     improvements. Physicians generally evaluate patients health and treatment benefits based on~     laboratory measures, such as the number of tender or swollen joints, duration of morning~     stiffness, grip strength, pain severity and others. Less attention is given to whether these~     treatment results are meaningful to patients. This study will examine how much of an~     improvement in pain, stiffness, function, and other symptoms is needed before patients~     consider the change an important improvement.~      Patients 18 years of age or older who were diagnosed with rheumatoid arthritis after age 16~     and who have active arthritis (6 or more tender joints) may be eligible for this study. Of~     particular interest are patients beginning treatment with prednisone, methotrexate,~     leflunomide, infliximab, or etanercept, although patients receiving any type of treatment may~     be included.~      Participants will be evaluated twice at the NIH Clinical Center, once at the start of the~     study and again at either 1 month or 4 months later, depending on the individual s treatment~     regimen. Permission will also be requested to review patients medical records for results of~     previous blood tests and x-rays. At each NIH visit, patients will undergo the following tests~     and procedures:~        -  Medical history and physical examination, including evaluation of joint swelling and~          tenderness;~        -  Questionnaires about rheumatoid arthritis symptoms;~        -  Computer-based exercise to assess preferences for various state-of-health choices;~        -  Grip strength test;~        -  Walking test on level ground, with or without the use of a cane or walker;~        -  Blood test to measure inflammation.~      At the second visit, in addition to the above procedures, participants will complete a~     questionnaire to rate the importance of changes, if any, in pain, morning stiffness, fatigue,~     joint swelling, functioning, worry, depression, and overall impressions, since the first~     visit.~   "
268316|NCT00056576|"~     The purpose of this study is to determine whether zonisamide alone is effective as a~     treatment for epilepsy in newly diagnosed cases.~   "
268317|NCT00056563|"~     The goals of this study are to determine if simultaneous bilateral subthalamic nucleus~     stimulation or simultaneous bilateral globus pallidus stimulation is more effective in~     reducing symptoms of Parkinson's disease, and if deep brain stimulation or best medical~     therapy is more effective in improving Parkinson's disease symptoms~   "
268318|NCT00056550|"~     Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous~     thrombosis and pulmonary embolism, particularly during certain high risk procedures. The~     trial is focusing on patients with confirmed hereditary antithrombin deficiency who are~     undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will~     test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior~     to, during and following the period of risk or surgical procedure.~   "
268319|NCT00056537|"~     The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one~     that triggers an attack on the tumor cells by activating some white blood cells belonging to~     the body's normal immune system. In animals, this results in an accumulation of white blood~     cells in the cancer that can fight the cancer. This study will test how much of the drug can~     be given to patients with non-small cell lung cancer, renal clear cell carcinoma, or~     pancreatic cancer without causing unacceptable side effects.~   "
268320|NCT00056524|"~     The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of~     Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes~     of uncontrolled crying and/or laughter).~   "
268321|NCT00056511|"~     The purpose of this study is to determine whether fresh garlic can positively affect~     cholesterol in adults with moderately high cholesterol levels. This study will also determine~     whether the same effects can be found for two main types of garlic supplements: a dried~     powdered garlic (designed to yield the same effect as fresh garlic) and an aged garlic~     extract preparation.~   "
268322|NCT00056498|"~     This study will determine whether adding the drug risperidone (Risperdal®) is more effective~     than placebo in treating schizophrenic patients who are taking the drug clozapine.~   "
268323|NCT00056485|"~     This study will implement a treatment for depression in a nursing home setting.~   "
268324|NCT00056472|"~     This study will determine the effectiveness of combining selective serotonin reuptake~     inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.~   "
268325|NCT00012454|"~     This study will test the safety and effectiveness of a protein called E-selectin, given as a~     nasal spray, in preventing the formation of blood clots that can cause stroke. In animal~     studies, animals that received E-selectin in the nose on a regular schedule had almost no~     strokes compared with those that did not receive it.~      Patients over age 45 who have had a stroke or transient ischemic attack (TIA) within 1 to 4~     months of this study may be eligible to participate. Candidates will be screened with a~     review of their past medical records and neurologic and medical evaluations that may include~     magnetic resonance imaging (MRI) of the brain, ultrasound or magnetic resonance angiography~     (a type of MRI) of the carotid arteries (arteries in the neck that supply blood to the~     brain), echocardiography (ultrasound test of the heart), electrocardiography (EKG) and blood~     tests.~      Participants will have a blood and urine test and will be assigned to one of four treatment~     groups. Patients in each group will spray a small amount of fluid into their nose according~     to the following schedule: 5 doses once every other day for 10-days, followed in 3 weeks by~     another 5 doses every other day for 10-days, followed in 3 weeks by a final series of 5 doses~     every other day for 10 days. The spray for patients in each group contains the following:~        -  Group 1 - fluid with low dose of E-selectin~        -  Group 2 - fluid with medium dose of E-selectin~        -  Group 3 - fluid with high dose of E-selectin~        -  Group 4 - fluid with no E-selectin~      Patients will be seen for follow-up visits at 1 month and 3 months after starting E-selectin~     therapy. The visits will include a neurologic examination and blood and urine tests. Patients~     will be contacted by phone, fax or e-mail in between the 1- and 3-month visits.~   "
268326|NCT00056459|"~     To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus~     oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread~     to other organs and are seeking first chemotherapy treatment~   "
268327|NCT00056446|"~     The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus~     vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer~     that has spread to other organs and whose disease has worsened after treatment with~     irinotecan.~   "
268328|NCT00056433|"~     Patients with sickle cell disease have abnormal hemoglobin (the protein in red blood cells~     that carries oxygen to the body). This abnormality causes red blood cells to take on a sickle~     shape, producing disease symptoms. Fetal hemoglobin, a type of hemoglobin present in fetuses~     and babies, can prevent red cells from sickling. The drug hydroxyurea increases fetal~     hemoglobin production in patients with sickle cell disease by making a molecule called nitric~     oxide. The drugs L-arginine and Sildenafil (Viagra) increase the amount or the effect of~     nitric oxide. This study will evaluate:~        -  The safety of giving L-arginine or Sildenafil together with hydroxyurea in patients with~          sickle cell disease;~        -  The effectiveness of L-arginine plus hydroxyurea or Sildenafil plus hydroxyurea in~          increasing fetal hemoglobin in patients with sickle cell disease; and~        -  The effectiveness of L-arginine plus hydroxyurea or Sildenafil and hydroxyurea in~          lowering blood pressure in the lungs of patients with sickle cell disease. (Pulmonary~          blood pressure is elevated in about one-third of patients with sickle cell disease, and~          this condition increases the risk of dying from the disease.)~      Patients with hemoglobin S-only, S-beta-thalassemia, or other sickle cell disease genotype~     may be eligible for this study.~      Before starting treatment, patients will have a complete medical history and physical~     examination. All patients will take hydroxyurea once a day every day by mouth for at least 2~     months. They will be admitted to the NIH Clinical Center to take their first dose of~     hydroxyurea, and will have blood drawn through a catheter (plastic tube placed in a vein)~     every hour for 6 hours for tests to determine nitric oxide levels. After discharge, they will~     return to the clinic once every 2 weeks to check for treatment side effects and for blood~     tests to monitor hemoglobin and fetal hemoglobin levels. After fetal hemoglobin levels have~     been stable for 2 months, patients will be admitted to the Clinical Center for their first~     dose of L-arginine (for men) or Sildenafil (for women). Again, blood samples will be~     collected through a catheter once an hour for 6 hours. If there are no complications,~     patients will be discharged and will continue taking hydroxyurea once a day and L-arginine or~     Sildenafil three times a day for at least 3 months until fetal hemoglobin levels have been~     stable for at least 2 months. Patients will return to the clinic for blood tests every week~     for 2 weeks and then every 2 weeks to monitor hemoglobin and fetal hemoglobin levels and to~     check for treatment side effects.~      Patients will have eye examinations before and during treatment. Some patients with sickle~     cell disease develop abnormalities in the blood vessels of the eye. Also, Sildenafil can~     cause temporary changes in color vision. Rarely, more serious eye problems can occur, such as~     bleeding from the eye blood vessels or damage to the retina a layer of tissue that lines the~     back of the eye. Patients will also have an echocardiogram (ultrasound of the heart) before~     beginning treatment, after hydroxyurea treatment, and after 1 and 3 months of combined~     treatment with hydroxyurea and L-arginine or Sildenafil to help measure blood pressure in the~     lungs.~      Patients who develop complications from L-arginine or Sildenafil may continue in the study on~     hydroxyurea alone. Patients whose fetal hemoglobin levels increase with the combination~     therapy of hydroxyurea and L-arginine or Sildenafil may continue to take them.~   "
268329|NCT00056420|"~     This study will use electroencephalography (EEG) and electromyography (EMG) to examine how~     the brain generates tics and controls voluntary movement in patients with Tourette's syndrome~     and chronic motor tic disorder. EEG records the electrical activity of the brain. For this~     test, a cap with built-in electrodes is placed on the subject's head, and the electrodes are~     connected to a monitor that records the brain activity. EMG records muscle activity using~     electrodes placed on the skin over muscles on the fingers or above the outer corner of the~     eyes.~      Healthy normal volunteers and patients with Tourette's syndrome and chronic motor tic~     disorder between 21 and 65 years of age may be eligible for this 2- to 3-hour study. Each~     candidate will be screened with a medical history, physical and neurological examinations,~     and a questionnaire that screens for psychiatric disorders.~      During EEG and EMG recordings, participants undergo the following tasks while seated~     comfortably in a sound-shielded room:~      Patients~        -  Finger task: Patients raise their index finger once every 10 seconds for about 25~          minutes.~        -  Tic evaluation and mimicking: Patients allow their tics to occur as they do naturally.~          After each tic, they report whether the tic was voluntary and whether it was preceded by~          a sensation of urge. They then mimic tics that they normally have, at a rate of about~          once every 10 seconds.~        -  Tic suppression task: Patients suppress tics they normally have for several minutes.~          They then allow the tics to occur naturally, without attempting to suppress them.~      Normal Volunteers~        -  Finger task: Volunteers raise their index finger once every 10 seconds for about 25~          minutes.~        -  Open eye task: Volunteers keep their eyes open for a minute or so, and then resume~          blinking as often as feels comfortable. The process is repeated several times.~   "
268330|NCT00056407|"~     This 4-year study will compare how safe and effective an oral investigational medicine is~     (compared to placebo) in preventing the development of prostate cancer in men that are~     defined by the study entrance criteria as being at an increased risk for prostate cancer.~     Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits),~     and a prostate biopsy will be performed at 2 and 4 years of treatment.~   "
268482|NCT00054249|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of T900607 in treating patients who have~     gastroesophageal junction cancer.~   "
268331|NCT00056394|"~     Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health~     problem. Medical treatments are now being used much earlier in the course of RA, but these~     treatments do not address the challenges of coping with the early stages of this disease.~     This study will determine whether a comprehensive coping skills training program can decrease~     pain, psychological disability, and physical disability in patients with early RA.~   "
268332|NCT00056381|"~     Anidulafungin is a medicine being developed for treatment of adults with certain kinds of~     fungal infections. This study is evaluating anidulafungin in children and adolescents who~     have fever and a low white blood cell count (neutropenia).~   "
268333|NCT00056368|"~     Anidulafungin is a medicine being developed for treatment of patients with certain kinds of~     fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus,~     in the blood or in other areas within the body.~   "
268334|NCT00056329|"~     The goal of this study is to determine the safety and efficacy of the administration of~     vitamin E, which has been shown to delay the progression of Alzheimer's disease, in slowing~     the rate of cognitive/functional decline in older persons with Down syndrome.~   "
268335|NCT00056355|"~     This study will examine the safety and effectiveness of extracorporeal photopheresis (ECP) in~     controlling Crohn's disease symptoms as patients taper their corticosteroid dose. Crohn's~     disease is a chronic inflammatory bowel disease. Patients commonly have chronic diarrhea with~     abdominal pain, loss of appetite and weight loss. Acute disease flares are treated with large~     doses of corticosteroids, but long-term use of these drugs can have harmful side effects. ECP~     (described below), is approved to treat skin symptoms associated with a type of cancer called~     cutaneous T-cell lymphoma and has been used experimentally in conditions involving abnormal~     inflammation.~      Patients 18 years of age and older who have had Crohn's disease for at least 6 months, who~     are corticosteroid-dependent, and whose symptoms are controlled well enough so that their~     Crohn's Disease Activity Index (CDAI) is less than 220, may be eligible for this study.~     Candidates will be screened with a medical history and review of medical records, physical~     examination, electrocardiogram, blood tests, urine pregnancy test for women of childbearing~     potential, and a questionnaire about how Crohn's disease affects their life and activities.~      Patients with a CDAI score of less than 150 will begin ECP treatments as soon as possible.~     Those with scores from 150 to 219 will have their corticosteroid dose increased enough to~     bring their CDAI score to below 150 before beginning ECP. Patients who do not achieve a CDAI~     of less than 150 after 4 to 6 weeks of increased corticosteroids will be excluded from the~     study.~      Participants will have ECP treatments for 2 consecutive days every 2 weeks for 24 weeks, for~     a total of 26 treatments. For ECP, patients undergo leukapheresis, a method of collecting~     large numbers of white blood cells, or leukocytes-cells that may be responsible for many of~     the medical problems in Crohn's disease. Whole blood is collected through a needle in an arm~     vein, similar to donating a unit of blood. The blood flows through a machine that separates~     it into its components by spinning. The white cells are removed and collected in a plastic~     bag, and the red blood cells and plasma are returned to the patient's bloodstream through the~     same needle. The collected white cells are mixed with a drug called UVADEX® (Registered~     Trademark), exposed to ultraviolet (UVA) light, and then returned to the patients'~     bloodstream. (The UVADEX allows the blood cells to absorb more UVA.) The UVA changes the~     cells in a way that, once they are back in the body, they cause changes in other cells like~     them. Each ECP treatment takes 3 to 4 hours. On the first day of each 2-day treatment,~     patients will undergo a review of symptoms, check of vital signs, and blood draw. They will~     complete a CDAI diary for 7 days before the first of the two ECP treatments and a~     questionnaire about their life and activities at 4-week intervals. During the ECP treatment~     period, corticosteroids will be slowly reduced as long as disease symptoms do not worsen.~      Patients whose disease remains under control with cessation of all steroids may begin~     maintenance ECP, 2 days in a row every 4 weeks for an additional 20 weeks (another 10~     treatments), with the same follow-up as described above, and a full physical examination 4~     weeks after the final treatment. Patients who were able to reduce, but not stop, steroid~     treatment may be considered for maintenance therapy if it is thought that continuing~     treatment may enable further reduction of steroids. Patients whose disease symptoms worsen~     with ECP or who have not been able to decrease their steroid dose will not be eligible for~     maintenance therapy and their participation in the study will end.~   "
268336|NCT00056316|"~     The purpose of this study was to develop and examine the initial impact of a distance-based~     intervention for female family dementia caregivers. As stated in the original proposal, the~     primary hypothesis of the study was that family caregivers who participated in the Video~     Intervention would show greater reduction in psychological distress (i.e., on measures of~     depression and emotional distress following problematic patient behaviors) compared to those~     in the Basic Education condition, and that this effect would be maintained over time (3 and 6~     months post-tx).~   "
268337|NCT00056303|"~     This study will determine the effectiveness of a relationship-based intervention in improving~     the interaction between caregivers and young children placed in their care.~   "
268338|NCT00056290|"~     This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF~     (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This~     condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic~     material that is injected into the muscles of the leg. Once in the leg, it has been shown to~     cause new blood vessels to grow under a variety of conditions.~   "
268339|NCT00056277|"~     A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with~     Bipolar Disorder~   "
268340|NCT00056264|"~     The purpose of this study is to evaluate the safety and effectiveness of infliximab~     (Remicade) in patients with Chronic Obstructive Pulmonary Disease (COPD). Infliximab~     (Remicade) targets specific proteins in the body's immune system to help control the~     development of inflammation to help reduce painful disease.~   "
268341|NCT00056251|"~     Patients with interstitial cystitis who meet eligibility requirements will be randomized to~     one of four treatment arms (3 RTX, Placebo). Study drug is administered as a single~     instillation within the urinary bladder. Study duration is 12 weeks.~   "
268342|NCT00056238|"~     The main objective of this study is to evaluate the safety, tolerability and pharmacokinetics~     of Cerebril™ in Cerebral Amyloid Angiopathy (CAA) patients who have had lobar cerebral~     hemorrhage.~   "
268343|NCT00056225|"~     The purpose of this study is to determine whether reduction of homocysteine levels with~     high-dose folate (folic acid), B6, and B12 supplementation will slow the rate of cognitive~     decline in persons with Alzheimer's disease.~   "
268344|NCT00056212|"~     This study will compare the effectiveness of yoga classes, exercise classes, and a self-care~     book in the management of pain and function for people with low back pain.~   "
268345|NCT00056173|"~     This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense~     oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in~     combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma.~     Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell~     carcinoma.~   "
268346|NCT00056199|"~     This study will test the ability of the experimental drug EYE001 to reduce retinal thickening~     and improve vision in patients with Von Hippel-Lindau syndrome (VHL). Angiomas (blood vessel~     tumors) commonly develop in the back of the eye on the retina and the optic nerve in patients~     with VHL. Although the tumors are not cancerous, they may cause significant vision loss.~     Current treatments, including laser therapy, cryotherapy, and vitrectomy, may not be~     successful or possible for all patients. EYE001 decreases production of VEGF, a growth factor~     that is important for the formation of new blood vessels and that is elevated in VHL.~     Preliminary findings from studies of other retinal diseases suggest that EYE001 can reduce~     retinal thickening and improve vision.~      Patients 18 years of age and older with retinal angiomas due to VHL in one or both eyes and~     central vision loss of 20/40 or worse may be eligible for this study. Participants will~     undergo the following tests and procedures:~        -  Medical history, physical examination, electrocardiogram (EKG) and blood tests.~        -  Eye examination, including eye pressure measurement and dilation of the pupils to~          examine the retina.~        -  Fluorescein angiography to evaluate the eye's blood vessels. For this test, a yellow dye~          is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of~          the retina are taken using a camera that flashes a blue light into the eye. The pictures~          will reveal if any dye has leaked from the vessels into the retina, indicating possible~          blood vessel abnormality.~        -  Optical coherence tomography to measure retinal thickness. The eyes are examined through~          a machine that produces cross-sectional pictures of the retina. These measures are~          repeated during the study to determine changes, if any, in retinal thickening.~        -  Electroretinogram (ERG) to measure electrical responses generated from within the~          retina. For this test, the patient sits in a dark room for 30 minutes with his or her~          eyes patched. Then, a small silver disk electrode is taped to the forehead, the eye~          patches are removed, the surface of the eye is numbed with eye drops, and contact lenses~          are placed on the eyes. The patient looks inside an open white globe that emits a series~          of light flashes for about 20 minutes. The contact lenses sense small electrical signals~          generated by the retina when the light flashes.~        -  Stereoscopic color fundus photography to examine the back of the eye. The pupils are~          dilated with eye drops to examine and photograph the back of the eye.~        -  EYE001 injections to treat ocular angiomas. Patients receive EYE001 injections through a~          needle into the eye's vitreous (gel-like substance that fills the inside of the eye).~          Six injections are given over a 30-week period. Before each injection, the surface of~          the eye is numbed with anesthetic eye drops. This is followed by injection of another~          anesthetic into the lower portion of they eye in the clear tissue surrounding the white~          of the eye. After a few minutes, the EYE001 is injected into the vitreous. Patients~          receive EYE001 injections at the first visit (during enrollment) and again at 6, 12, 18,~          24, and 30 weeks after the first injection.~      At each injection visit, participants repeat most of the tests described above to evaluate~     the response to treatment and return a week later for another eye examination. After the last~     injection, patients whose vision has improved may receive three more treatments at visits 36,~     42, and 48. All participants will return for examinations at week 54 and at 2 months after~     their final injection.~   "
268347|NCT00056186|"~     The purposes of this study are to learn about significant life changes for people with~     Friedreich's ataxia and about patients' experiences with health care providers. Friedreich's~     ataxia is a rare genetic disorder in which patients experience progressive muscle weakness~     and loss of coordination in the arms and legs. They may have other complications, such as~     vision and hearing impairment, dysarthria, scoliosis, diabetes, and heart disease. The study~     will explore the impact of this chronic progressive illness on transitional life events, such~     as career choice and marriage, and the role of family members and health care~     providers-particularly genetic counselors-in helping patients progress through these events.~      Patients with Friedreich's ataxia who are 18 years of age or older may be eligible for this~     study. Those enrolled will participate in a 45- to 60-minute interview by phone or in person,~     in which they will be asked questions about important changes in their lives and their past~     experiences with health care providers. The interview will be audiotaped.~   "
268348|NCT00056160|"~     Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing~     identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will~     participate in a treatment phase and a follow-up phase.~   "
268349|NCT00056147|"~     The purpose of this study is to assess the safety and effectiveness of multiple dosages of~     INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis~     (CF) lung disease. Study drug will be administered through a nebulizer (a device that~     delivers medication as a mist by breathing it in).~   "
268350|NCT00056134|"~     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make~     the body build an immune response to kill tumor cells. Biological therapies such as~     denileukin diftitox may be able to deliver cancer-killing substances directly to melanoma~     cells. Combining vaccine therapy with biological therapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining vaccine therapy with~     denileukin diftitox in treating patients who have stage III or stage IV melanoma.~   "
268498|NCT00054015|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have~     advanced prostate cancer that has been previously treated with hormone therapy.~   "
268351|NCT00056095|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in~     treating patients with metastatic kidney cancer.~   "
268352|NCT00056082|"~     RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or~     recurrence of cancer. Celecoxib may be effective in preventing breast cancer in at-risk~     women.~      PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing breast cancer~     in premenopausal women who are at risk of developing cancer.~   "
268353|NCT00056069|"~     RATIONALE: Studying the physical and emotional needs of parents who are caring for children~     receiving chemotherapy for cancer may help doctors plan effective treatments for the patient~     that allow for improved quality of life of the patient's family.~      PURPOSE: This clinical trial is studying the different physical and emotional needs of~     parents whose children are undergoing chemotherapy for acute lymphoblastic leukemia either in~     an outpatient clinic or in the hospital.~   "
268354|NCT00056056|"~     RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more~     sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy~     is more effective with or without bexarotene in treating mycosis fungoides.~      PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy~     using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.~   "
268355|NCT00056030|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells.~     Combining chemotherapy with cetuximab may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with cetuximab works in treating patients with unresectable liver metastases from colorectal~     cancer.~   "
268356|NCT00056004|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of zileuton may be an effective way to prevent~     lung cancer in patients who have bronchial dysplasia.~      PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung~     cancer in patients who have bronchial dysplasia.~   "
268357|NCT00055991|"~     RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or~     recurrence of cancer. It is not yet known whether bexarotene is effective in preventing~     breast cancer.~      PURPOSE: Randomized clinical trial to study the effectiveness of bexarotene in preventing~     breast cancer in women who are at genetic risk of developing breast cancer.~   "
268358|NCT00055978|"~     RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or~     recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence~     of lung cancer in former heavy smokers.~      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the~     development or recurrence of lung cancer in former heavy smokers who are at risk of~     developing cancer.~   "
268359|NCT00055965|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if one regimen will require patients to spend more time in the hospital than the~     other regimen for treatment of chemotherapy-related side effects.~      PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are~     receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine~     combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.~   "
268360|NCT00055952|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients~     who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor~     or desmoplastic small round cell tumor.~   "
268361|NCT00055939|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating children~     who have relapsed or refractory rhabdomyosarcoma.~   "
268362|NCT00055926|"~     RATIONALE: CP-724,714 may stop the growth of tumor cells by blocking the enzymes necessary~     for tumor cell growth.~      PURPOSE: Phase I trial to study the effectiveness of CP-724,714 in treating patients who have~     metastatic HER2-overexpressing breast cancer.~   "
268363|NCT00055913|"~     This randomized phase I/II trial is to see if combining erlotinib with bevacizumab works~     better in treating patients who have recurrent or metastatic head and neck cancer. Erlotinib~     may stop the growth of tumor cells by blocking the enzymes needed for tumor cell growth.~     Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or deliver cancer-killing substances to them. Combining erlotinib with bevacizumab may~     kill more tumor cells.~   "
268364|NCT00055887|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Drugs such as efaproxiral may make the tumor cells more sensitive to radiation therapy. It is~     not yet known if chemotherapy combined with radiation therapy is more effective with or~     without efaproxiral in treating non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined~     with radiation therapy with or without efaproxiral in treating patients who have stage III~     non-small cell lung cancer.~   "
268378|NCT00055679|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective in treating early breast~     cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of~     combination chemotherapy in treating women who have stage I breast cancer.~   "
271223|NCT00035854|"~     This study will treat pediatric patients who have infections that are due to a specific~     bacteria (Vancomycin-Resistant Enterococcus)~   "
268365|NCT00055874|"~     RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of~     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. Also, imatinib mesylate may stop the growth of cancer cells by blocking the enzymes~     needed for cancer cell growth. Interferon alfa may interfere with the growth of cancer cells~     and slow the growth of cancer. When the healthy stem cells from a donor are infused into the~     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood~     cells, and platelets. It is not yet known which treatment regimen is most effective in~     treating chronic phase chronic myelogenous leukemia.~      PURPOSE: This randomized phase III trial is studying imatinib mesylate with or without~     interferon alfa or cytarabine to see how well it works compared with interferon alfa followed~     by donor stem cell transplant in treating patients with newly diagnosed chronic phase chronic~     myelogenous leukemia.~   "
268366|NCT00055861|"~     This phase II trial is to see if combining bevacizumab with docetaxel works in treating women~     who have locally advanced or metastatic breast cancer. Drugs used in chemotherapy work in~     different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal~     antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody~     therapy may kill more tumor cells.~   "
268367|NCT00055848|"~     RATIONALE: Genetic studies may help in understanding the genetic processes involved in the~     development of some types of cancer.~      PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer~     or adenomatous polyps.~   "
268368|NCT00055835|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine, and~     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or~     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy~     before radiation therapy, and combining chemotherapy with radiation therapy, may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of neoadjuvant gemcitabine, paclitaxel,~     and carboplatin followed by cisplatin and radiation therapy in treating patients who have~     locally advanced or recurrent carcinoma (cancer) of the urothelium.~   "
268369|NCT00055822|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Oblimersen~     may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the~     drugs.~      PURPOSE: Phase I/II trial to study the effectiveness of combining oxaliplatin, fluorouracil,~     and leucovorin with oblimersen in treating patients who have unresectable, metastatic, or~     recurrent colorectal cancer.~   "
268370|NCT00055809|"~     This randomized phase II trial is to see if combining bevacizumab with PEG-interferon alfa-2b~     works in treating patients who have metastatic or unresectable carcinoid tumors. Monoclonal~     antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     deliver cancer-killing substances to them. PEG-interferon alfa-2b may stop the growth of~     cancer by stopping blood flow to the tumor. Combining bevacizumab with PEG-interferon alfa-2b~     may kill more cancer cells~   "
268371|NCT00055783|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have progressive or recurrent Hodgkin's lymphoma.~   "
268372|NCT00055770|"~     Phase I/II trial to study the effectiveness of combining erlotinib with docetaxel in treating~     patients who have locally advanced, recurrent, or metastatic head and neck cancer. Erlotinib~     may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs~     used in chemotherapy work in different ways to stop tumor cells from dividing so they stop~     growing or die. Combining erlotinib with docetaxel may kill more tumor cells.~   "
268373|NCT00055757|"~     Phase II trial to study the effectiveness of combining tipifarnib with gemcitabine and~     cisplatin in treating patients who have stage III or stage IV non-small cell lung cancer.~     Drugs used in chemotherapy such as gemcitabine and cisplatin use different ways to stop tumor~     cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor~     cells by blocking the enzymes necessary for tumor cell growth. Combining tipifarnib with~     combination chemotherapy may kill more tumor cells.~   "
268374|NCT00055731|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as~     nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from~     producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. It is not yet known whether hormone therapy is more~     effective with or without chemotherapy in treating prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or~     without docetaxel and estramustine in treating patients who have prostate cancer that is~     locally advanced or at high risk of relapse.~   "
268375|NCT00055718|"~     RATIONALE: Silymarin (milk thistle extract) is an herb that may be effective in treating~     liver disorders caused by cancer therapy.~      PURPOSE: Randomized phase II trial to study the effectiveness of silymarin in treating~     patients who have acute lymphoblastic leukemia with chemotherapy-related side effects to the~     liver.~   "
268376|NCT00055705|"~     RATIONALE: PV701 may be able to kill tumor cells while leaving normal cells undamaged.~      PURPOSE: Phase I trial to study the effectiveness of PV701 in treating patients who have~     advanced or recurrent ovarian epithelial, fallopian tube, primary peritoneal, colorectal, or~     other cancer found primarily within the peritoneal cavity.~   "
268377|NCT00055692|"~     This phase II trial is to see if bevacizumab works in treating patients who have unresectable~     nonmetastatic liver cancer that has not spread to the main portal vein. Monoclonal~     antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     deliver cancer-killing substances to them.~   "
268379|NCT00055666|"~     RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host~     disease of the gastrointestinal tract.~      PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host~     disease of the gastrointestinal tract that has not responded to previous therapy.~   "
268380|NCT00055653|"~     RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were~     destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of allogeneic umbilical cord blood~     transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic~     disorders.~   "
268381|NCT00055640|"~     RATIONALE: Analyzing genes that are present in cancer cells may be useful as a method for~     predicting the response of non-Hodgkin's lymphoma to cancer treatment. Imaging procedures~     such as positron emission tomography (PET) scans may improve the ability to measure how well~     cancer has responded to treatment.~      PURPOSE: This phase II trial is studying molecular risk assessment to see how well it works~     in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's~     lymphoma.~   "
268382|NCT00055614|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have~     advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.~   "
268383|NCT00055601|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy (RT) uses high-energy x-rays to~     damage tumor cells. It is not yet known which regimen of combination chemotherapy plus~     radiation therapy with or without surgery is more effective in treating bladder cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of two combination chemotherapy~     regimens and radiation therapy with or without radical cystectomy in treating patients who~     have stage II or stage III bladder cancer.~   "
268384|NCT00022139|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy, such as paclitaxel, carboplatin, and fluorouracil, work in different ways to~     stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with~     chemotherapy and giving them before surgery may shrink the tumor so that it can be removed~     during surgery.~      PURPOSE: This phase II trial is studying how well giving radiation therapy together with~     combination chemotherapy followed by esophagectomy works in treating patients with locally~     advanced cancer of the esophagus or gastroesophageal junction.~   "
268385|NCT00005028|"~     Phase II trial to study the effectiveness of combining paclitaxel and bryostatin 1 in~     treating patients who have metastatic prostate cancer that has not responded to hormone~     therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~   "
268386|NCT00055588|"~     This study will identify changes that occur in the nervous system of healthy normal~     volunteers while they are learning a cycling task.~      Healthy subjects 18 years of age and older who can cycle for 16 minutes may be eligible for~     this study. Candidates will be screened with a brief medical history and physical~     examination.~      Participants will be assigned to one of three groups:~        -  Complex training: Cycling for 16 minutes at a constant speed of 60 rpm with frequent~          changes in pedal resistance.~        -  Simple training: Cycling for 16 minutes at a constant speed of 60 rpm with no changes in~          pedal resistance.~        -  No training: Remaining seated on the bike for 16 minutes performing no exercise.~      Participants will cycle for 16 minutes for the training task, plus 4 minutes before and after~     the training. Reflexes will be measured with nerve conduction studies and somatosensory~     evoked potential (SSEP) recordings before and after training. Nerve conduction studies~     measure the speed with which nerves conduct electrical impulses and the strength of the~     connection between the nerve and the muscle. For these studies, a probe is placed on the skin~     over the calf muscles and the knee to deliver a small electrical stimulus, and wires are~     taped to the skin to record the impulses. SSEP recordings, which measure of the excitability~     of the brain to sensory stimuli, are collected from electrodes placed on the scalp.~      After the training period, multiple train stimulation (MTS) is applied for 10 minutes. For~     MTS, weak electrical currents are delivered for 10 seconds every 10 seconds. These stimuli~     produce a buzzing sensation without pain, discomfort, or muscle twitching. The MTS is~     followed by another 4 minutes of cycling.~      Participants also undergo transcranial magnetic stimulation (TMS). For this procedure, an~     insulated wire coil is held over the scalp. A brief electrical current is passed through the~     coil, creating a magnetic pulse that travels through the scalp and skull and causes small~     electrical currents in the brain cortex (outer part of the brain). The stimulation may cause~     twitching in the muscles of the face, arm, or leg. The electrical activity of the muscles is~     recorded with a computer or other recording device, using electrodes attached to the skin~     with tape.~   "
268387|NCT00055575|"~     This study looks at the role of a specific brain chemical system in the mood and attention~     symptoms seen in major depression and bipolar disorders using functional brain imaging....~   "
268388|NCT00055562|"~     Subjects are randomized to one of two treatment arms. All subjects are screened for~     eligibility within 28 days prior to randomization. The study consists of a treatment phase~     and a follow-up phase. Subjects will be treated in repeating 4 week cycles.~   "
268389|NCT00055536|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of~     natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission~     (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that~     natalizumab may stop the movement of certain cells, known as white blood cells, into bowel~     tissue. These cells are thought to cause damage in the bowel leading to the symptoms of~     Crohn's disease.~      Patients who complete this study may be eligible for long-term natalizumab therapy via~     extension protocol ELN100226-351.~   "
268390|NCT00055523|"~     Purpose of the study is to test whether adalimumab can induce clinical remission in subjects~     with active Crohn's disease when compared to placebo (an inactive substance)~   "
268391|NCT00055549|"~     This study will examine how dextromethorphan, a drug that alters reflexes of the larynx~     (voice box), might change voice symptoms in people with voice disorders due to uncontrolled~     laryngeal muscle spasms. These include abductor spasmodic dysphonia (breathy voice breaks),~     adductor spasmodic dysphonia (vowel breaks), muscular tension dysphonia (tight strained~     voice), and vocal tremor (tremulous voice). Dextromethorphan-one of a group of drugs called~     NMDA antagonists-has been used for years in over-the-counter cough suppressant medicines. In~     animal studies, the drug has blocked one of the reflexes in the larynx that may be associated~     with spasms in the laryngeal muscles. This study will compare the effects of~     dextromethorphan, lorazepam (a valium-type drug), and a placebo (inactive substance) in~     patients with the four types of voice disorders described above.~      Patients with spasmodic dysphonia, muscular tension dysphonia and vocal tremor may be~     eligible for this study. Individuals who smoke or use tobacco, who have vocal nodules or~     polyps, or who have a history of airway obstruction may not participate. Candidates will be~     screened with a medical history and physical examination, a questionnaire, voice recording~     (repeating sentences into a microphone), and nasolaryngoscopy (examination of the larynx with~     a tube advanced through the nose). For the nasolaryngoscopy, the inside of the nose is~     sprayed with a decongestant (to open the nasal passages) and possibly a local anesthetic. A~     small, flexible tube called a nasolaryngoscope is passed through the nose to look at the~     larynx during speech and other tasks, such as singing, whistling and prolonged vowels.~      Participants will be admitted to the NIH Clinical Center for each of three visits, which will~     last from the afternoon of one day to late afternoon of the following day. At each visit,~     patients will complete a questionnaire, baseline speech recording, and a test for sedation~     level. They will take three pills-either dextromethorphan, lorazepam, or placebo-one every 6~     hours. Vital signs will be checked every 6 hours and the level of sedation during waking~     hours will be monitored. One to three hours after taking the third pill, speech recording,~     questionnaire and test of sedation will be repeated to check for possible voice changes.~     Patients will be given a different pill at each visit.~   "
271224|NCT00035841|"~     The purpose of this study is to determine the effectiveness of TLK286 in treatment of~     metastatic breast cancer.~   "
268392|NCT00055510|"~     This research study is intended to evaluate the safety and effectiveness of 3 different doses~     of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice~     a day compared to placebo (an inactive substance) in preventing restenosis (closure of~     vessel) within six months after stent implantation. Patients must be enrolled into this study~     within 24 hours after the stenting procedure.~      Additionally, over a 1- to 9-month post-stent period, the study will compare the safety and~     effectiveness of BO-653 versus placebo for measures of coronary artery vessel size by~     quantitative coronary angiography, major adverse cardiac events, and effects on the oxidative~     status of plasma lipids and other plasma components.~   "
268393|NCT00055497|"~     The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of~     clinical remission up to 56 weeks in participants with Crohn's disease who participated in~     NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with~     Crohn's disease up to 56 weeks.~   "
268394|NCT00055484|"~     The purpose of this study is to determine if zonisamide is effective as a preventative~     medication for individuals with migraine headache.~   "
268395|NCT00055471|"~     The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in~     men with prostate cancer~   "
268396|NCT00055445|"~     This study will measure the safety and tolerability of three different doses of IdB 1016 in~     patients with hepatitis C disease who have not responded to or are poor candidates for~     interferon-based therapies.~      NOTE: THE STUDY WILL ONLY RECRUIT STUDY PARTICIPANTS AT UNIVERSITY OF WASHINGTON MEDICAL~     CENTER IN SEATTLE~   "
268397|NCT00055432|"~     This study hopes to evaluate whether the combination of Gemzar plus Alimta will have any~     beneficial effects for patients with recurrent platinum-sensitive or platinum-resistant~     ovarian or peritoneal cancer. Treatments are weekly for two weeks, with the 3rd week off and~     will be repeated every 21 days. Side effects and the overall safety of the treatment will~     also be monitored and evaluated. In addition, a Quality of Life questionnaire is part of this~     study to help measure patient perceived benefits or drawbacks to this treatment regimen.~   "
268398|NCT00055419|"~     The purpose of this clinical research study is to learn about the safety of cetuximab in~     patients with stage IV colorectal cancer, and who may benefit from cetuximab.~   "
268399|NCT00055393|"~     This study will determine whether the drug bupropion is an effective treatment for~     Pathological Gambling.~   "
268400|NCT00055380|"~     This study will examine the effects of certain investigational anti-cancer drugs on the~     genetic and protein makeup of cells. The findings will be entered into a database that may be~     used to: 1) determine the optimal dose of drug that will provide the most benefit with the~     least harmful side effects; and 2) predict which patients will have a greater chance of~     developing side effects or a greater chance of benefiting from the drug.~      Patients 18 years of age and older who are receiving the anti-cancer drugs flavopiridol or~     perifosine in an NIH clinical trial may be eligible for this study.~      Participants will undergo the following procedures both before starting treatment and during~     the first treatment cycle to look for genetic or chemical changes produced in response to the~     study drug:~        -  Blood draws.~        -  Buccal cell brushings: Collection of buccal cells (cells lining the inside of the~          cheeks) from the inside of the cheeks using a soft bristle brush for a few seconds~          several times. The patient then rinses the mouth with salt water for 1 minute and then~          spits into a cup.~        -  Buccal cell biopsies (on both sides of the mouth): For this procedure, a local~          anesthetic is given to numb the biopsy area. Then, a small piece of tissue from the~          inner lining of the mouth is removed with a small sharp cookie-cutter instrument. The~          biopsy findings will be compared with those of the cheek brushings to see if the~          information is similar.~        -  Tumor biopsies: In patients whose tumor is easily accessible, such as the skin abdominal~          fluid, tissue biopsies will be requested. Depending on the type and location of the~          tumor, the biopsy may be done with a forceps, a large needle (needle biopsy), a~          cookie-cutter instrument (punch biopsy), or a small knife (excisional biopsy). All of~          these procedures are done with a local anesthetic.~   "
268401|NCT00055367|"~     The purpose of this study is to determine the safety and tolerability of natalizumab in~     adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD).~     It is thought that natalizumab may stop the movement of certain cells, known as white blood~     cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the~     symptoms of Crohn's disease.~      Patients who complete this study may be eligible for long-term natalizumab therapy via~     extension protocol ELN100226-352.~   "
268402|NCT00055354|"~     The purpose of this study is to evaluate acupuncture as a treatment for Post-Traumatic Stress~     Disorder (PTSD) and to correlate the diagnosis of PTSD with Traditional Chinese Medicine~     (TCM) diagnostic patterns.~   "
268403|NCT00055341|"~     Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C~     virus (HCV) infection. However, HCV infection progresses differently in patients who are~     coinfected with HIV and in hemophiliacs. This study will evaluate the effectiveness of~     PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs.~   "
268404|NCT00055328|"~     This study will compare a brief form of counseling to usual care for the treatment of minor~     depression in the primary care setting.~   "
268405|NCT00055315|"~     This study will expose patients to either a Systems Training for Emotional Predictability and~     Problem Solving (STEPPS) or treatment as usual (TAU) to determine the more effective therapy~     for treating borderline personality disorder.~   "
268406|NCT00055302|"~     The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1~     mg given once daily in subjects with McCune-Albright Syndrome.~   "
268407|NCT00055263|"~     The purposes of this study are to:~        -  Test the safety of DN-101 in patients with advanced malignancies~        -  Understand how fast the body absorbs, processes, and eliminates DN-101~        -  Determine the highest dose of DN-101 that is well tolerated by cancer patients~        -  Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the~          approved product~   "
268420|NCT00055094|"~     While most people with HIV experience significant destruction of their immune systems, some~     people appear to have preserved immune function and can control the virus without drugs.~     Early treatment with anti-HIV drugs may help preserve the immune system, allowing it to~     control the virus once the drugs are stopped. This study will evaluate the immune system~     response of HIV infected people who are treated with anti-HIV drugs soon after being~     infected.~   "
268421|NCT00055081|"~     The purpose of this study is to examine how services and housing provided for homeless~     families affect the mental health and behavior of homeless children over time.~   "
268422|NCT00055068|"~     This study will evaluate a treatment program for young children with Obsessive Compulsive~     Disorder (OCD) and their families.~   "
271225|NCT00035828|"~     To determine if ABX-IL8 will improve shortness of breath.~   "
268408|NCT00055289|"~     This study will use transcranial magnetic stimulation (TMS) to investigate functions of brain~     regions that may use information from sensory organs, such as the eyes or ears, to generate~     movements.~      For TMS, a wire coil is held over the scalp. A brief electrical current is passed through the~     coil, creating a magnetic pulse that stimulates the brain. This may cause a pulling sensation~     on the skin under the coil and twitching in muscles of the face, arm, or leg. During the~     stimulation, the participant may be asked to tense certain muscles slightly or perform other~     simple actions.~      Healthy normal volunteers 18 years of age and older may be eligible for this study.~     Individuals with a history of neuropsychiatric disorders, brain lesions such as tumors,~     stroke, or trauma, or a history of significant medical disorders, such as cancer, may not~     participate. Candidates will be screened with a medical history, brief physical examination,~     and questionnaire.~      Participants will be presented a sequence of shapes (circles, rectangles, and triangle) and~     will count the number of a specified shape. Each number is assigned to a corresponding~     response button. The subject will push the appropriate button with the corresponding finger.~     During these experiments, the scalp will be stimulated by TMS. Each set of TMS measurements~     will take up to 3-1/2 hours.~   "
268409|NCT00055250|"~     The purpose of this study is to determine the effectiveness and side effects of LY293111~     given in combination with gemcitabine in patients with pancreatic cancer.~   "
268410|NCT00055237|"~     This study will examine the safety and effectiveness of the experimental drug bevacizumab for~     treating both non-acquired immune deficiency syndrome (AIDS) and AIDS-associated Kaposi's~     sarcoma (KS). KS tumors depend on the formation of new blood vessels for their growth.~     Bevacizumab is an antibody to a protein called vascular endothelial growth factor (VEGF) that~     is produced by the body and is involved in blood vessel growth. Bevacizumab may block the~     action of VEGF, and thus help shrink KS lesions.~      Patients 18 years of age and older with Kaposi's sarcoma that is restricted to the skin and~     is not life threatening may be eligible for this study. Candidates will be screened with a~     medical history and physical examination, blood and urine tests, electrocardiogram (EKG),~     chest x-ray, and, if needed, imaging studies to evaluate internal tumors.~      Participants will receive bevacizumab intravenously (by vein) once a week for 2 weeks and~     then every 3 weeks at the National Institutes of Health (NIH) Clinical Center. The first~     infusion takes about 90 minutes, the second takes about 60 minutes, and subsequent infusions~     take about 30 minutes. Infusions may take longer, however, if the drug is better tolerated at~     a slower infusion rate. Patients will be evaluated with the following tests and procedures:~        -  Physical examination, assessment of drug side effects, measurement of KS lesions, and~          photographs of lesions once a week for the first 6 weeks of therapy, and then every 3~          weeks.~        -  cluster of differentiation 4 (CD4) cell counts and human immunodeficiency virus (HIV)~          viral load in HIV-positive patients every 12 weeks.~        -  Biopsies of lesions: upon entering the study, at week 12, and at the time of a response~          of the tumor to therapy or at the end of treatment, if treatment ends at week 18 or~          later.~        -  Additional biopsies, if requested. (Additional biopsies are not required.)~        -  Other procedures, such as computed tomography (CT) or magnetic resonance imaging (MRI)~          scans, if medically indicated.~      Patients may continue bevacizumab therapy indefinitely if they are benefiting from it, as~     long as they have no substantial toxicity or other conditions that would cause them to stop~     receiving it and the protocol remains open.~   "
268411|NCT00055224|"~     Fear and anxiety are normal responses to a threat. However, anxiety is considered abnormal~     when the response to the threat is excessive or inappropriate. This study will examine~     changes in the body and brain that occur during unpleasant learning experiences in healthy~     volunteers with high, moderate, and low levels of anxiety.~      A high degree of generalized anxiety is a component of many anxiety disorders and is regarded~     as a marker of vulnerability for these disorders. People with anxiety disorders and~     individuals with high degrees of anxiety have inappropriate expectations of unpleasant~     events. This study will investigate the development of expecting unpleasant events in healthy~     volunteers with varying degrees of anxiety using aversive conditioning models. A later phase~     of the study will enroll participants with anxiety disorders and compare their responses to~     those of healthy volunteers.~      Patients who meet criteria for an anxiety disorder, and healthy volunteers who have no~     history of psychiatric or major medical illness will be enrolled in this study. Volunteers~     will come to the NIH Clinical Center three times for outpatient testing....~   "
268412|NCT00055198|"~     The purpose of this study is to provide daptomycin, an antibiotic, to patients who are~     failing conventional therapy, or who cannot take approved antibiotics for one reason or~     another.~   "
268413|NCT00055185|"~     The purpose of this study is to determine any adverse effects of PRO 542 after administration~     and to determine the anti-HIV effects of PRO 542 in the patient.~   "
268414|NCT00055146|"~     The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously~     treated patients with chronic lymphocytic leukemia (CLL)~   "
268415|NCT00055133|"~     Paxceed™ is being developed by Angiotech Pharmaceuticals, Inc. for the treatment of~     Rheumatoid Arthritis (RA). The main objective of this study is to determine the effectiveness~     of treatment with Paxceed™ in patients with RA. In RA, there is an increase in cell growth~     and changes in cell function. The active substance in Paxceed™, paclitaxel, has undergone~     clinical studies as a cancer chemotherapeutic agent and has demonstrated its usefulness as an~     agent that stops growth of cells and blocks certain types of cell function associated with~     RA. Because of these effects, it is thought that Paxceed™ might alter the destructive course~     of RA.~   "
268416|NCT00055172|"~     This study will examine the role of hereditary factors in different forms of severe combined~     immunodeficiency (SCID).~      Patients with immunodeficiencies may be eligible for this study. Candidates include:~        -  Patients with diminished numbers of T cells or NK cells or both, or~        -  Patients with normal T cell and NK cell numbers but diminished T cell, B cell, or NK~          cell function.~      Relatives of patients will also be studied.~      Participants will have blood samples collected for genetic analysis in studies related to~     SCID at the National Institutes of Health and other institutions.~   "
268417|NCT00055159|"~     This study will test the effectiveness of low-dose recombinant tissue plasminogen activator~     (rtPA, or alteplase) in dissolving blood clots in major arm or neck veins. rtPA is given to~     patients with heart attacks to dissolve blood clots in blocked coronary arteries. Blood clots~     that develop in major arm or neck veins usually develop after a venous access device (VAD) or~     catheter has been placed in the vein. The clot often causes arm, shoulder or neck swelling~     and pressure or discomfort. Current treatments include removing the VAD, using blood thinners~     such as heparin and warfarin, or using rtPA to dissolve the clot. All these options have~     disadvantages, however, including the risk of abnormal bleeding. This study will evaluate~     whether lower doses of rtPA can effectively dissolve clots without requiring an extended~     hospital stay, as is needed with the current higher-dose regimen.~      Patients 18 years of age and older who are enrolled in or are being evaluated for a Clinical~     Center study and who have a blocked jugular, axillary, subclavian, or brachiocephalic vein~     may be eligible for this study. The blockage may or may not be associated with use of a VAD.~      Participants will have one or two treatments with a low dose of rtPA, followed by a blood~     thinner taken by mouth or by injection for 5 to 7 weeks. On the first treatment day, the~     patient has a venogram, in which a catheter is placed in an arm vein and passed up to and~     through the blood clot that is blocking the blood flow in the vein. This is done under an~     x-ray machine so the radiologist can see exactly where the tube is going. Then, rtPA is~     injected into the clot about every 30 seconds for 15 to 30 minutes. The catheter is kept in~     place to maintain access to the vein for additional treatment the next day, if needed. The~     patient then begins treatment with heparin, either as an outpatient or an inpatient. A second~     venogram is done the next day. If the venogram shows that the vein is open, anti-clotting~     treatment with heparin or warfarin continues. If the venogram shows that the vein is still~     blocked, the rtPA treatment is repeated while the blood thinner treatment continues. The~     patient has a third venogram the following day. If the vein has opened, heparin and warfarin~     treatment continues. If the vein is still blocked, the patient's participation in the study~     ends. Although the patient is no longer formally in the study, he or she may choose to~     receive additional treatments with rtPA in higher doses at NIH or to continue using blood~     thinners under the direction of the primary physician.~      Blood tests are done during blood thinning therapy to monitor and adjust the dosage.~     Additional blood samples are taken before and at timed intervals after each rtPA treatment to~     measure the response to therapy. Patients who benefit from rtPA treatment remain on blood~     thinners for 5 to 7 weeks and then return to NIH for a follow-up venogram to see if the vein~     is still open. During warfarin therapy, blood tests are done every few days during the first~     week or two and every 2 weeks thereafter to ensure the optimal drug dose is being~     administered. If the repeat venogram at 5 to 7 weeks shows that the vein has closed, the~     blood thinners (warfarin or heparin) will be stopped and the patient's participation in this~     study will end. If the vein has remained open, the patient's doctor will decide whether or~     not to continue anti-clotting therapy.~   "
268418|NCT00055120|"~     The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV~     infected patients who are being treated for opportunistic infections (OIs). This study will~     follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with~     an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from~     the OI.~   "
268419|NCT00055107|"~     Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a~     significant problem for HIV infected children in developing countries. C. parvum infection~     can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV~     infected children. The purpose of this study is to test the safety of NTZ in HIV infected~     children who have chronic diarrhea caused by C. parvum.~      Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants,~     children, and adolescents with chronic diarrhea caused by C. parvum infection.~   "
268423|NCT00055055|"~     This study will examine families in which one sibling of a sibling pair, or twin pair, has~     developed a systemic rheumatic disease and one has not, to see if and how the two differ in~     the following:~        -  Blood cell metabolism;~        -  Types of cells in the blood;~        -  Environmental exposures or genetic factors that might explain why one developed disease~          and the other did not.~      Families in which one sibling has developed a systemic rheumatic disease, rheumatoid~     arthritis, systemic lupus erythematosus, scleroderma, dermatomyositis, or myositis, and the~     other has not, are eligible for this study. The siblings may or may not be twins, but must be~     of the same gender and be within a 5-year age difference. Biological parents, or, in some~     cases, children, will also be included in the study. Normal, healthy volunteers will serve as~     control subjects.~      Participants will undergo some or all of the following tests and procedures:~        -  Medical history and physical examination. Participants will also be asked permission to~          obtain medical records for review.~        -  Questionnaires about environmental exposures at work, at home, and elsewhere. Probands~          (participants with rheumatic disease) and their healthy siblings will also answer~          questions about infections, vaccinations, medications or dietary supplements, sun~          exposure, and stressful events during the year before disease diagnosis in the affected~          sibling.~        -  Blood and urine collection for the following tests:~        -  Routine blood chemistries and other studies to rule out certain diseases or medical~          problems;~        -  Evidence of past toxic exposures and certain infections;~        -  Presence of cells from the mother in the child s blood and vice versa. (Recent studies~          suggest that during pregnancy or delivery, cells from the mother and baby may be~          exchanged and circulate in the body for many years, possibly causing problems);~        -  In twin or sibling pairs, presence of certain genes that may be more common in patients~          with systematic rheumatic diseases as compared with their unaffected siblings and normal~          volunteers;~        -  In identical twins, comparison of their blood cell metabolism to see if and how the~          metabolism differs in people with rheumatic disease.~      Participants may be asked for permission to have some of their blood and urine samples stored~     and to obtain previously collected blood or tissue biopsy specimens that are no longer needed~     for clinical care, for research purposes. They may also be asked to give additional blood or~     urine samples.~      Participants will be followed every year for 5 years (either in person or by questionnaire)~     to evaluate any changes in their condition. The final 5-year evaluation will repeat some of~     the questionnaires and procedures described above.~   "
268424|NCT00055042|"~     This study will compare the side effects of two laser treatments for diabetic macular edema,~     a common condition in patients with diabetes. In macular edema, blood vessels in the retina-a~     thin layer of tissue that lines the back of the eye-become leaky and the retina swells. The~     macula-the center part of the retina that is responsible for fine vision-may also swell and~     cause vision loss. Traditional laser treatment (argon blue or green, or yellow) for macular~     swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision.~     A different type of laser (diode) may have less damaging effects to the eye and fewer~     long-term adverse effects, but this is not known. The results of this study on side effects~     of the treatments will be used to design a larger study of effectiveness. The study will also~     examine whether vitamin E can reduce the damage caused by laser treatment. Patients with~     elevated cholesterol levels will be invited to participate in a cholesterol reduction part of~     the study to compare normal-pace cholesterol reduction with accelerated reduction.~      Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be~     eligible for this study. Candidates will be screened with the following tests and procedures:~        -  Medical history and physical examination.~        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to~          examine pupils, lens, retina and eye movements. The pupils will be dilated with drops~          for this examination.~        -  Blood tests to measure cholesterol and vitamin E blood levels, blood clotting time,~          hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney~          function.~        -  Eye photography to help evaluate the status of the retina and changes that may occur in~          the future. Special photographs of the inside of the eye are taken using a camera that~          flashes a bright light into the eye.~        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected~          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina~          are taken using a camera that flashes a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating possible blood vessel~          abnormality.~        -  Multifocal electroretinogram to measure electrical responses generated within the~          retina. The test, which takes about 1-1/2 hours, is painless.~      Participants will be randomly assigned to take 1600 IU of vitamin E or placebo (an inactive,~     look-alike pill) daily. After taking the pills for 3 months or more, patients who require~     laser treatment will be randomly assigned to one of the two laser therapies. (Patients with~     macular edema in both eyes will receive both treatments, one in each eye.) For these~     procedures, eye drops are put in the eye to numb the surface and a contact lens is placed on~     the eye during the laser beam application. Several visits may be required for additional~     laser treatments. The maximum number of treatments depends on how well they are working.~     Patients will return for follow-up visits 1, 3, and 6 months after the first treatment, and~     then every 6 months until either the patient returns for a 3-year visit; the last enrolled~     patient returns for the 1-year visit; or the patient requests to leave the study. During the~     follow-up visits, patients' response to treatment will be evaluated with repeat tests of~     several of the screening exams.~   "
268425|NCT00055029|"~     This study will explore the causes and eye problems of X-linked juvenile retinoschisis~     (XLRS), an inherited disease that causes vision loss primarily in young males. The vision~     loss, which worsens over time, is a result of schisis, or splitting, of the layers of the~     retina (tissue that lines the back of the eye). A better understanding of why and how XLRS~     develops might lead to improved treatments.~      Patients 9 months of age and older with XLRS and females who are suspected carriers of the~     gene responsible for the disease (such as the mother of the patient) may be eligible for this~     study. Other family members of patients also may be enrolled.~      Patients will undergo the following tests and procedures:~        -  Personal and family medical history to review past and current medical conditions and~          treatments, particularly regarding eye disease, and to construct a family tree.~        -  Eye examination to assess visual acuity (eye chart test) and examine pupils, lens,~          retina, and eye movements. The pupils will be dilated with drops for this examination.~        -  Photography of the retina to help evaluate the status of the retina.~        -  Specialized eye tests to evaluate color vision, field of vision, and ability to see in~          the dark.~        -  Electroretinogram (ERG) to examine what happens to the eyes after a flash of bright~          light. For this test, the patient sits in a dark room for 30 minutes with his or her~          eyes patched. Then, a small silver disk electrode is taped to the forehead, the eye~          patches are removed, the surface of the eye is numbed with eye drops and contact lenses~          are placed on the eyes. The patient looks inside a large empty bowl and then a light~          flashes, first in the dark and then with a light turned on inside the bowl. The contact~          lenses sense small electrical signals generated by the retina when the light flashes.~        -  Blood test to examine DNA for genetic study of XLRS.~      Family members will provide a blood sample for genetic study.~   "
268426|NCT00055016|"~     The purpose of this study is to compile a registry of patients with Fabry disease, an~     inherited metabolic disorder. In this disease, an enzyme called a-galactosidase A, which~     normally breaks down a lipid (fatty substance) called globotriaosylceramide (Gb3), is missing~     or does not function properly. As a result, Gb3 accumulates, causing problems with the~     kidneys, heart, nerves, and blood vessels. It is not known exactly how lipid accumulation~     causes these problems, but in another lipid storage disease called Gaucher disease the~     illness can be reversed if the accumulated lipid is removed by repeated intravenous (into a~     vein) infusions of the deficient enzyme.~      The Fabry disease registry is a voluntary and anonymous list of patients that includes~     information about their health and allows doctors to follow changes in their symptoms and~     test results over time. It also allows doctors to compare symptoms between patients who are~     receiving certain therapies with those who are not receiving therapy. The goals of the~     registry are to:~        -  Better understand the natural history of Fabry disease, including disease variations~          within and between affected families;~        -  Provide a basis for developing guidelines for disease management;~        -  Evaluate how treatment affects the course of disease;~        -  Provide high-quality data and analyses that will help to continuously develop better~          treatments.~      Patients of all ages with biochemical or genetic evidence of Fabry disease (i.e., individuals~     who have a deficiency of the enzyme a-galactosidase A or a mutation in the gene that encodes~     this enzyme, or both) are eligible for this study. This worldwide study will include 100~     patients participating in Fabry disease studies at the NIH. These patients will come to the~     NIH Clinical Center only as required for participation their Fabry disease study. No~     additional procedures will be required for the current registry study.~      NIH patients will take part in the registry study for their lifetime, or as long as they are~     being followed at the NIH for their Fabry disease. At their regularly scheduled NIH clinic~     visits, participants will have routine medical procedures and examinations deemed necessary~     by the doctor. The results of blood and urine tests taken at these visits will be entered~     into the registry database. Blood tests will include information on genotype (determination~     of which gene mutation is responsible for the disease), a-galactosidase A levels, Gb3 levels,~     and creatinine. Urine tests results will include creatinine clearance (a measure of kidney~     function) and protein evaluation.~   "
268427|NCT00055003|"~     The purpose of this study is to use brain imaging technology to examine the effect of the~     hormone hydrocortisone on the brain's response to various facial expressions.~      Glucocorticoids can influence emotional behavior and cognition; when given long-term, the~     hormones may lead to mania or depression. One way glucocorticoids may influence emotional~     behavior is by affecting the activity of certain parts of the brain that participate in~     emotional processing. Brain imaging studies indicate that the amygdala, ventral medial~     prefrontal, and other prefrontal cortical areas of the brain are activated during tasks that~     require processing of emotional stimuli. These brain structures contain dense concentrations~     of glucocorticoid receptors. This study will use functional magnetic resonance imaging (fMRI)~     to study the brain activity of participants as they view faces that express different~     emotions. Participants will perform this task under a dose of either the glucocorticoid~     hydrocortisone or placebo (an inactive solution).~      Participants in this study will be screened with a medical history, physical examination,~     blood tests, and an interview about their mood, degree of nervousness, and behavior. On Visit~     1, participants will undergo screening and neuropsychological testing. For 3 days prior to~     Visit 2, participants will collect their saliva. During Visit 2, participants will undergo~     MRI scans of the brain after infusion with either a high or low dose of hydrocortisone or~     placebo. Participants will also undergo functional MRI (fMRI). Blood samples will be~     collected every 15 minutes during the scan. Following the MRI, participants will take~     attention and memory tests.~   "
268461|NCT00054561|"~     RATIONALE: Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor~     cells from dividing so they stop growing or die. Interferon alfa may interfere with the~     growth of tumor cells. Vitamin E may be able to decrease side effects caused by isotretinoin.~     It is not yet known whether combining isotretinoin and interferon alfa with vitamin E is more~     effective than observation in preventing recurrence of head and neck cancer after surgery~     and/or radiation therapy.~      PURPOSE: Randomized phase III trial to compare the effectiveness of isotretinoin and~     interferon alfa combined with vitamin E with that of observation in treating patients who~     have undergone surgery and/or radiation therapy for stage III or stage IV head and neck~     cancer.~   "
271303|NCT00034775|"~     The primary purpose of the study is to assess the safety and tolerability of a long-acting~     injectable formulation of risperidone when switching from an oral antipsychotic in patients~     with schizophrenia.~   "
268428|NCT00054990|"~     This study will evaluate the usefulness of transcranial magnetic stimulation (TMS) in~     measuring cortical excitability. The cortex is the outer part of the brain. Patients with~     seizures have increased cortical excitability and are often treated with antiepileptic drugs~     to reduce this excitability. The therapeutic effects of antiepileptic drugs are usually~     tracked with blood tests that measure their blood levels. However, these blood tests may not~     always correctly reflect the effects of the drugs on the brain.~      TMS has been used successfully to measure cortical excitability in many neurological~     diseases, including epilepsy, and may be helpful in measuring drug effects on the brain~     directly. For this procedure, a wire coil is held over the scalp. A brief electrical current~     is passed through the coil, creating a magnetic pulse that stimulates the brain. This may~     cause a pulling sensation on the skin under the coil and twitching in muscles of the face,~     arm, or leg. During the stimulation, the participant may be asked to tense certain muscles~     slightly or perform other simple actions.~      Healthy normal volunteers between 18 and 55 years of age may be eligible for this study.~     Candidates will be screened with a medical history, physical and neurological examination,~     electroencephalogram (EEG), and blood tests.~      On the first day of the study, participants will have a baseline TMS and will be randomly~     assigned to take one of two antiepileptic drugs: group A will take the carbamazepine; group B~     will take lamotrigine. If they wish, participants may be admitted to the NIH Clinical Center~     for the first 5 days of drug administration while the proper dosage is being determined. They~     will then be discharged and continue taking the drug for a total of 36 days. During this~     time, they will have daily blood tests and TMS from days 2 through 5, and again on days 12~     and 36. Group A will have additional blood sampling and TMS on days 37, 39, 44, and 53; Group~     B will have blood tests and TMS on days 38, 40, 45, and 53.~   "
268429|NCT00054977|"~     This is a Phase I, multi-center study of GM-CT-01, which has been shown to increase the~     anti-tumor activity of 5-fluorouracil in mice. The primary reason for doing the study is to~     determine the safety of GM-CT-01 given alone and in combination with therapeutical dosage of~     5-Fluorouracil, in patients who have advanced cancer that can be measured by CT scan.~   "
268430|NCT00054964|"~     This study was designed to examine the effectiveness of a breath-operated albuterol inhaler~     in asthma patients who have difficulty using their standard press-and-breathe inhaler.~   "
268431|NCT00054951|"~     MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to “stick,” to~     magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is~     added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and~     deposited in the area of a tumor, where it is thought that it then “leaks” through the blood~     vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes “free~     from” the magnetic beads and will then be able to act against the tumor cells. The iron~     component of the particle has magnetic properties making it possible to direct MTC-DOX to~     specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that~     MTC-DOX used with the magnet may target the chemotherapy directly to liver tumors and provide~     a treatment to patients with liver cancer.~      Patients enrolled in the study will be administered MTC-DOX through a hepatic artery catheter~     inserted under radiological guidance. During and following injection of the MTC-DOX, the drug~     will be localized to the hepatic tumor site by use of an external magnet. Dose may be divided~     in order to localize MTC-DOX to all lesions. The MTC-DOX intrahepatic infusions will be~     repeated every three weeks until tumor progression, complete remission, unacceptable~     toxicity, or a maximum of six treatment cycles.~      The purpose of this Phase 1/2 study is to evaluate time to disease progression following~     administration of MTC-DOX.~   "
268432|NCT00054938|"~     The purpose of this study is to find the best way to prevent heart disease and stroke in~     people with lupus (systemic lupus erythematosis, or SLE). The study will evaluate the~     effectiveness of medication and a phone-based education program in controlling four risk~     factors for heart disease: smoking, obesity, high blood pressure, and inactivity. The study~     will also test the safety of commonly used heart medications in people with lupus.~   "
268433|NCT00054925|"~     To determine the effectiveness of continuous patient contact on weight loss maintenance.~   "
268434|NCT00054912|"~     EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is~     designed to activate the immune system to develop a response against tumor cells in order to~     delay or prevent the recurrence of cancer. This study will test the safety and measure the~     level of immune stimulating capability of EP2101 in patients with Colon Cancer.~   "
268435|NCT00054899|"~     EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is~     designed to activate the immune system to develop a response against tumor cells in order to~     delay or prevent the recurrence of cancer. This study will test the safety and measure the~     level of immune stimulating capability of EP2101 in patients with Non-Small Cell Lung Cancer.~   "
268436|NCT00054886|"~     The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a~     treatment for metastatic kidney cancer.~   "
268437|NCT00054873|"~     The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given~     alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal~     or gastric adenocarcinoma.~   "
268438|NCT00054860|"~     The purpose of this study is to test the safety of an HIV DNA vaccine (EP HIV-1090) and to~     test whether or not the vaccine can stimulate immune system responses in HIV uninfected~     people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.~   "
268439|NCT00054847|"~     VA patients with coronary artery disease and who have agreed to undergo coronary artery~     bypass graft surgery would be randomized to receive either radial artery or saphenous vein to~     the study vessel. The primary outcome variable is graft patency at one year.~   "
268440|NCT00054834|"~     The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in~     the treatment of Non-Hodgkin's lymphoma.~   "
268462|NCT00054548|"~     Phase I trial to study the effectiveness of combining carboplatin and paclitaxel with~     oblimersen in treating patients who have advanced solid tumors. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen~     may increase the effectiveness of carboplatin and paclitaxel by making tumor cells more~     sensitive to the drugs.~   "
268463|NCT00054535|"~     RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells.~     Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.~      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with~     interleukin-2 in treating patients who have metastatic melanoma.~   "
268464|NCT00054522|"~     RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may~     increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.~      PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone~     in treating patients with prostate cancer who have undergone surgery or radiation therapy.~   "
268441|NCT00054821|"~     Joint injury and trauma dramatically increase the risk of developing osteoarthritis (OA). The~     purpose of this study is to determine what factors lead to decreased pain, improved joint~     function, and repair of the joint surface in post-traumatic OA.~      Study hypotheses: 1) Ankle motion during distraction will result in clinically significant~     improvements in Ankle Osteoarthritis Scale scores, SF-36 scores, and improved cartilage~     thickness distribution over the habitually most heavily loaded portion of the articular~     surface, as compared to the use of distraction without ankle motion. 2a) Ankles with low~     geometric surface irregularity and greater range of motion will have better preservation of~     neo-chondroid tissue (increased normalized cartilage thickness and reduced longitudinal~     compressive strain in the habitually heavily regions of the articular surface) than those~     with high surface irregularity. 2b) Low geometric surface irregularity and greater range of~     motion will have reduced habitual focal or regional contact stress elevation. 3) Joints that~     have better improvements in Ankle Osteoarthritis Scale scores and improved cartilage~     thickness distribution over habitually heavily loaded portion of the articular surface will~     have improved normalization of synovial fluid markers of biosynthetic/degradative activity~     and oxidative stress.~   "
268442|NCT00054808|"~     Eligible patients will have low- or intermediate-grade Non-Hodgkin's Lymphoma (NHL) that has~     progressed after standard chemotherapy. Patients will receive gallium nitrate 300 mg/m2/day~     by continuous IV infusion for 7 consecutive days using a portable infusion pump.~     Hospitalization is not required. Stable or responding patients will receive additional~     gallium nitrate infusions every 3 weeks until the time of disease progression, for a maximum~     total of 8 infusions, or 2 cycles after complete remission has been documented.~   "
268443|NCT00054795|"~     The primary purpose of the study is to determine if patients with brain metastases from~     non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation~     therapy retain their neurologic function and ability to think for a longer time compared to~     patients treated with whole brain radiation therapy alone.~   "
268444|NCT00054769|"~     Tuberculosis is a major cause of mortality among AIDS patients in the developing world. The~     diagnosis of tuberculosis in HIV infected children is complicated by inefficient and~     expensive tuberculosis tests and vague diagnostic criteria. This study will evaluate the~     accuracy and efficiency of several different tuberculosis tests that could be used in~     developing countries.~   "
268445|NCT00054730|"~     This study will investigate whether CX516 can improve attention, memory, language, or~     behavior in adults with Fragile X Syndrome and/or Autism.~      CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is~     evidence to suggest that the synapses in the brain of an individual with fragile X syndrome~     are immature and abnormal. It is possible CX516 may partially correct this synaptic~     transmission defect and lead to improvement in cognitive and behavioral functioning.~      There is also reason to believe that these changes caused by CX516 could be helpful in~     managing cognitive and behavioral symptoms in patients with autistic disorder.~      Involvement for each participant will last 28 days. Participants will be given study~     medication, a physical exam, and a variety of cognitive assessment tests to study potential~     drug effectiveness at improving disease symptoms.~   "
268446|NCT00054756|"~     This study will determine the safety and activity of a new formulation of~     thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with~     certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical~     signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is~     made), and the pituitary (another part of the brain). The TRH test helps assess this~     interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002.~     As a result, to have a continuous source of TRH available for NIH clinical and research~     purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade~     formulation of TRH for patient use. This study will test the CC formulation in healthy~     volunteers to show that its activity and side effects are similar to those of the previously~     available commercial test preparation. It will then be studied in CC patients for whom the~     diagnostic test is recommended.~      Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation~     of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients~     include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH~     secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will~     be screened with a medical history, physical examination, and blood tests. Women of~     child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may~     not participate.~      The TRH test procedure will be the same for healthy volunteers and patients. All participants~     fast from midnight before the morning of the test. In the morning, a catheter (flexible~     plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of~     blood samples. Blood pressure is monitored before and during the test. A blood sample is~     drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood~     samples are collected over a 3-hour period from the time of the TRH injection for measuring~     levels of various hormones. A total of less than 4 tablespoons of blood is taken for the~     test.~   "
268447|NCT00054743|"~     This study will determine whether blood levels of the anti-HIV medicine nevirapine are~     different in HIV-infected patients in the United States from patients in Uganda. People from~     all over the world take medications to treat HIV infection. These medicines work well in some~     people but not in others, and they cause harmful side effects in some people and not in~     others. These differences may be related to variations in how much of the drug reaches the~     blood. Differences in drug blood levels among people in various areas of the world may be~     attributed to differences in diet, state of health, ability to absorb the medicines from the~     stomach, ability to eliminate the drugs from the body, and the brand of medicine taken. This~     study will help scientists learn whether differences in blood levels of HIV medicines are~     important in determining how well the drugs work in different patient populations.~      HIV-infected patients 18 years of age and older in the United States and in Kampala, Uganda~     who have been on an antiretroviral treatment regimen that includes at least 28 consecutive~     days of nevirapine may be eligible for this study. Candidates will be screened with a medical~     history, physical examination, and blood tests.~      Participants will have a total of approximately about 5 ounces of blood drawn during this 6-~     to 8-hour study. They will come to the NIH clinic in the morning, and a catheter (plastic~     tube) will be inserted into an arm vein for collecting blood. (Alternatively, blood can be~     collected by a needle inserted into an arm vein.) Blood will be withdrawn according to the~     following schedule:~        -  About 5 tablespoons will be collected upon arrival at the clinic after an overnight~          fast. Within 30 minutes of this blood draw, the patient will have breakfast and take his~          or her morning dose of nevirapine, along with any other medications that need to be~          taken at that time.~        -  1 tablespoon of blood will be drawn 2 hours after the nevirapine dose.~        -  1 tablespoon of blood will be drawn 4 hours later (6 hours after the nevirapine dose).~      The blood will be analyzed for levels of nevirapine and possibly other HIV medicines. Some of~     the blood will be stored for later analysis of genes (cytochrome P450 and MDR1) that are~     involved in eliminating medicines from the body.~   "
268448|NCT00054717|"~     Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment~     regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected~     patients.~   "
268465|NCT00054496|"~     RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary~     for cancer cell growth.~      PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have~     recurrent or progressive glioblastoma multiforme.~   "
268466|NCT00054483|"~     Phase I trial to study the effectiveness of bortezomib in treating patients who have advanced~     cancer and kidney dysfunction. Bortezomib may stop the growth of cancer cells by blocking the~     enzymes necessary for cancer cell growth.~   "
268449|NCT00054704|"~     This study examines if Riluzole, FDA approved for ALS, will improve symptoms of depression in~     Bipolar Disorder.~      Purpose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark)~     for short-term treatment of depression symptoms, such as depressed mood, psychomotor~     retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by~     the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also~     known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute~     depression in patients with unipolar depression indicate that it may have antidepressant~     properties in some patients.~      Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may~     be eligible for this 8-week study. Candidates must be currently depressed, must have had at~     least one previous major depressive episode, and must have failed to improve with prior~     treatment with at least one antidepressant. They will be screened with a medical history,~     physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric~     evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing~     potential will have a pregnancy test.~      Participants will begin an 8-week course of treatment, starting with a placebo (a sugar pill~     formulated to look like the active drug) and, at some point, switching to riluzole. In~     addition to drug treatment, participants will undergo the following procedures:~      Physical examination and electrocardiogram (EKG) at the beginning and end of the study;~      Weekly check of vital signs (temperature, blood pressure and heart rate);~      Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess~     treatment response;~      Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects.~      At the end of the study, participants' psychiatric status will be reassessed and appropriate~     long-term psychiatric treatment arranged.~      Atendemos pacientes de habla hispana.~      We enroll eligible participants locally and from around the country. Travel arrangements are~     provided and costs covered by the National Institute of Mental Health (NIMH). (Arrangements~     vary by distance and by specific study.) After completing the study participants receive~     short-term follow-up care while transitioning back to a provider.~   "
268450|NCT00054691|"~     The goal of this clinical research study is to learn if the drug ZD1839 (Iressa) can shrink~     or slow the growth of cancer in participants with recurrent and/or metastatic squamous cell~     cancer (SCC) of the skin. The safety of this drug will also be studied.~   "
268451|NCT00054678|"~     The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential~     to add a new dimension to the management of post-infarct deterioration of cardiac function in~     subjects with congestive heart failure. Based on pre-clinical studies, implantation of~     autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with~     functioning muscle and improvement in myocardial performance. Preliminary data in human~     subjects suggest skeletal myoblast implantation at the time of CABG may lead to the same~     effects. In principal, myoblast implantation by catheter delivery may offer the same~     therapeutic benefit. The present clinical study is to be conducted primarily to evaluate the~     safety of MyoCell™ implantation using the MyoCath™ delivery system and secondarily to~     evaluate the effect on regional myocardial function post treatment.~   "
268452|NCT00050531|"~     The goal of this clinical research study is to learn if giving PEG-Alpha Interferon~     (PEG-Intron) and Sargramostim (GM-CSF) to patients receiving treatment with high dose Gleevec~     (imatinib mesylate) is more effective in treating CML in chronic phase than therapy with~     imatinib mesylate alone.~   "
268453|NCT00054665|"~     This study will examine the safety and effectiveness of an experimental drug called~     Bortezomib (PS-341), given alone and in combination with a chemotherapy regimen called~     Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin and Filgrastim (EPOCH), in~     treating non-Hodgkin's B-cell lymphoma. In the laboratory, PS-341 kills lymphoma cells and~     makes them more sensitive to chemotherapy. The EPOCH treatment regimen includes the drugs~     doxorubicin, etoposide, vincristine, cyclophosphamide, prednisone, and filgrastim.~      Patients 18 years of age and older with an aggressive non-Hodgkin's lymphoma that has~     relapsed after treatment or is not responding to chemotherapy may be eligible for this study.~     Candidates will be screened with a medical history and physical examination. Other tests that~     may be required include blood and urine tests; lung function studies; imaging tests such as~     magnetic resonance imaging, computed tomography and x-rays; and biopsy (surgical removal of a~     small tissue sample) of tumor, bone marrow, or other tissue.~      Upon entering the study, all participants will receive PS-341. The drug is given as a 3- to~     5-second intravenous (through a vein) injection twice a week for 2 weeks. This is followed by~     a 1-week rest. Each 3-week period comprises one treatment cycle. The number of cycles a~     patient receives depends on how well he or she responds to the drug. Patients who do not have~     a complete remission or whose tumor grows on this therapy will be offered PS-341 in~     combination with up to six cycles of EPOCH chemotherapy. The treatment for patients taking~     PS-341 plus EPOCH is as follows:~        -  PS-341, given by 3- to 5-second intravenous (IV) injection on days 1 and 4 of each~          cycle.~        -  Doxorubicin, etoposide, and vincristine, given by continuous IV infusion over 4 days,~          beginning on day 1 and ending on day 5 of each cycle. The drugs are delivered through a~          lightweight portable infusion pump to an indwelling IV catheter (plastic tube) in a~          vein.~        -  Cyclophosphamide, given by IV infusion over 15 minutes on day 5 of each cycle.~        -  Prednisone, given by mouth (pills) twice a day on days 1 through 5 of each cycle.~        -  Filgrastim, given by injection under the skin starting on day 6 of each cycle and~          continuing until the white blood cell count increases or until day 19 of the cycle.~      Patients also take a combination of antibiotics 3 days a week during EPOCH to prevent~     infection while resistance is lowered because of the chemotherapy. Etoposide, doxorubicin,~     and cyclophosphamide doses are adjusted as needed, based on white blood cell counts of the~     previous cycle. The first patients in the study will receive a low dose of PS-341. The dose~     will be increased in subsequent small groups of patients as long as the preceding dose is~     well tolerated.~      Drug therapy for patients who are candidates for bone marrow transplant will be tailored to~     permit transplantation. Patients who are not eligible for or who choose not to have a bone~     marrow transplant will be followed at the National Institutes of Health (NIH) every 3 months~     the first year, every 4 months the second year, every 6 months the third year, and then once~     a year until their disease progresses or the study ends. Patients may have tumor and bone~     marrow biopsies, blood draws, and computed tomography (CT) scans periodically to evaluate~     disease status and drug side effects.~   "
268454|NCT00054652|"~     This study will collect information on (tricks) patients with focal dystonia use to relieve~     their symptoms. Dystonia is a movement disorder caused by sustained muscle contractions often~     causing twisting and abnormal posturing. Dystonia may be generalized, affecting at least one~     leg and the trunk of the body, segmental, affecting adjacent body parts, or focal, affecting~     a single body part, such as the hand or eyelid. It may be task-specific, such as writer's,~     musician's or sportsman's cramps. Some patients with focal dystonia use (tricks), such as~     touching the face or hand, to stop or alleviate the abnormal movement. This study will survey~     the types of tricks people with focal dystonia use in order to learn more about the disorder.~      Patients 18 years of age and older with focal dystonia may be eligible for this study.~     Candidates will be screened for eligibility with a medical history, clinical evaluation, and~     review of their medical records.~      In one 30- to 45-minute clinic visit, participants will be interviewed about their dystonia~     symptoms and the tricks they use to relieve the symptoms. They may be asked to show the~     investigators how the tricks work~   "
268455|NCT00054639|"~     The goal of this clinical research study is to learn if the combination of oblimersen sodium~     and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell~     non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an~     investigational drug. The safety of this combination treatment will also be studied~   "
268456|NCT00054626|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known if combination chemotherapy is effective in~     preventing relapse in patients who have undergone radical cystectomy for bladder cancer.~      PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine~     with that of observation in treating patients with bladder cancer who have undergone surgery~     to remove the bladder.~   "
268457|NCT00054613|"~     The purpose of this study is to determine whether extracorporeal photoimmune therapy with~     UVADEX (ECP) added to standard therapy is effective in the treatment of chronic~     graft-versus-host disease (GvHD).~   "
268458|NCT00054600|"~     The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX~     (ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the~     prevention of Graft-versus-Host Disease (GvHD).~   "
268459|NCT00054587|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known~     which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more~     effective in treating breast cancer.~      PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus~     radiation therapy with or without trastuzumab in treating women who have breast cancer that~     has spread to lymph nodes in the axilla (under the arm).~   "
268460|NCT00054574|"~     RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them~     or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of ABX-EGF in treating patients who have~     prostate cancer that has not responded to hormone therapy.~   "
268481|NCT00054262|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of T900607 in treating patients who have~     unresectable liver cancer.~   "
268467|NCT00054470|"~     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary~     for tumor cell growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells.~     Combining tipifarnib with trastuzumab may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with trastuzumab~     in treating patients who have metastatic breast cancer.~   "
268468|NCT00054457|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study of the effectiveness of combining docetaxel with~     capecitabine in treating patients who have metastatic cancer of the stomach or~     gastroesophageal junction.~   "
268469|NCT00054444|"~     This phase I trial is studying the side effects and best way to give radiation therapy when~     given together with topotecan and cisplatin in treating patients with locally advanced~     cervical cancer. This trial is also studying the best dose of topotecan when given in this~     regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill~     more tumor cells.~   "
268470|NCT00054431|"~     This phase II trial is studying how well giving imatinib mesylate together with decitabine~     works in treating patients with accelerated or blast phase chronic myelogenous leukemia.~     Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for~     cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from~     dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may~     kill more cancer cells~   "
268471|NCT00054418|"~     RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer~     may decrease the risk of fractures and may help patients live more comfortably. It is not yet~     known whether calcium is more effective with or without risedronate in preventing bone loss.~      PURPOSE: This randomized phase III trial is studying two forms of calcium with or without~     risedronate to compare how well they work in preventing bone loss in premenopausal women who~     are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast~     cancer.~   "
268472|NCT00054405|"~     Phase I trial to compare the effectiveness of interleukin-12 with or without interleukin-2 in~     treating young patients who have refractory or recurrent neuroblastoma. Biological therapies~     use different ways to stimulate the immune system and stop cancer cells from growing.~     Combining interleukin-2 with interleukin-12 may kill more tumor cells.~   "
268473|NCT00054392|"~     RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining more~     than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is~     more effective in treating non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination~     chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent~     non-small cell lung cancer.~   "
268474|NCT00054353|"~     This phase I/II trial studies the side effects of giving reduced-intensity conditioning~     followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in~     treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as~     fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT~     helps stop the growth of cancer cells. It may also stop the patient's immune system from~     rejecting the donor's stem cells. The donated stem cells may replace the patient's immune~     cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from~     happening.~   "
268475|NCT00054340|"~     RATIONALE: Combining antithymocyte globulin with combination chemotherapy before donor~     peripheral stem cell transplantation may reduce the chance of developing graft-versus-host~     disease following transplantation.~      PURPOSE: Phase I/II trial to study the effectiveness of combining antithymocyte globulin with~     busulfan and cyclophosphamide in reducing graft-versus-host disease in patients who are~     undergoing donor stem cell transplantation for myelodysplastic syndrome or other~     myeloproliferative disorder.~   "
268476|NCT00054327|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell~     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When the stem cells from a related~     donor, that do not exactly match the patient's blood, are infused into the patient they may~     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets.~      PURPOSE: This phase II trial is studying how well giving chemotherapy with or without~     radiation therapy followed by donor stem cell transplant works in treating patients with~     hematologic cancer.~   "
268477|NCT00054314|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who~     have non-small cell lung cancer.~   "
268478|NCT00054301|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     during surgery followed by external-beam radiation to the entire breast may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy during surgery~     followed by whole-breast radiation therapy in treating women who have undergone lumpectomy~     for ductal carcinoma in situ or invasive breast cancer~   "
268479|NCT00054288|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in~     treating patients who have refractory advanced solid tumors.~   "
268480|NCT00054275|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in~     treating patients who have stage IV or recurrent breast cancer.~   "
268483|NCT00054236|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Umbilical cord blood transplantation may be able to replace~     cells destroyed by chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by~     umbilical cord blood transplantation in treating patients who have hematologic cancer or~     severe aplastic anemia.~   "
268484|NCT00054223|"~     RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to~     improve the way in which clinical trials are conducted.~      PURPOSE: This clinical trial is studying patients' personality traits, reasons for~     participating in the trial, and understanding of their medical situation, prognosis, and~     risks and benefits of participating in a phase I trial.~   "
268485|NCT00054210|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of chemotherapy is more effective in treating stage IIIB, stage IV,~     or recurrent non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel~     plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage~     IIIB, stage IV, or recurrent non-small cell lung cancer.~   "
268486|NCT00054197|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether polyglutamate paclitaxel is more effective than gemcitabine or vinorelbine~     in treating non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel~     with that of gemcitabine or vinorelbine in treating patients who have stage IIIB, stage IV,~     or recurrent non-small cell lung cancer.~   "
268487|NCT00054184|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether polyglutamate paclitaxel is more~     effective than docetaxel in treating non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel~     with that of docetaxel in treating patients who have progressive non-small cell lung cancer.~   "
268488|NCT00054171|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill cancer cells. Photosensitizing drugs such as aminolevulinic acid are absorbed~     by cancer cells and, when exposed to light, become active and kill the cancer cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of photodynamic therapy using~     aminolevulinic acid in treating patients who have cutaneous T-cell lymphoma, B-cell lymphoma,~     or early chronic lymphocytic leukemia involving the skin.~   "
268489|NCT00054158|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping~     blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and~     thalidomide in treating patients who have newly diagnosed stage I, stage II, or stage III~     multiple myeloma.~   "
268490|NCT00054145|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who~     have recurrent, refractory, locally advanced, or metastatic breast cancer.~   "
268491|NCT00054132|"~     This phase II trial studies how well erlotinib hydrochloride and bevacizumab work in treating~     patients with stage IV breast cancer. Erlotinib hydrochloride may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving~     erlotinib hydrochloride and bevacizumab may be an effective treatment for breast cancer.~   "
268492|NCT00054119|"~     Phase II trial to study the effectiveness of karenitecin in treating patients who have~     persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not~     responded to platinum-based treatment. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die.~   "
268493|NCT00054106|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as~     flutamide and buserelin may stop the adrenal glands from producing androgens. OGX-011 may~     help flutamide and buserelin kill more tumor cells by making tumor cells more sensitive to~     the drugs. Giving flutamide and buserelin with OGX-011 before surgery may shrink the tumor so~     it can be removed during surgery.~      PURPOSE: Phase I trial to study the effectiveness of combining hormone therapy with OGX-011~     before radical prostatectomy in treating patients who have prostate cancer.~   "
268494|NCT00054067|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known which regimen of radiation therapy combined with chemotherapy, with~     or without surgery, is more effective in treating early cancer of the cervix.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery followed by~     different regimens of radiation therapy and chemotherapy with that of chemotherapy and~     radiation therapy alone in treating patients who have stage I cancer of the cervix.~   "
268495|NCT00054054|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation~     therapy in treating patients with stage III or stage IV head and neck cancer.~   "
268496|NCT00054041|"~     Vaccines made from antigens may make the body build an immune response to kill abnormal~     cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial~     to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who~     have cervical intraepithelial neoplasia~   "
268497|NCT00054028|"~     This phase I/II trial studies the best dose of suramin when given together with paclitaxel in~     treating women with stage IIIB-IV breast cancer. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the~     effectiveness of paclitaxel by making tumor cells more sensitive to the drug.~   "
268499|NCT00054002|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill cancer cells. Combining photodynamic therapy with surgery may be an effective~     treatment for malignant mesothelioma.~      PURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with~     surgery in treating patients who have malignant mesothelioma.~   "
268500|NCT00053989|"~     RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell~     transplant helps stop the growth of cancer cells. It also stops the patient's immune system~     from rejecting the donor's stem cells. The donated stem cells may replace the patient's~     immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving~     an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help~     increase this effect. Sometimes the transplanted cells from a donor can also make an immune~     response against the body's normal cells. Giving immunosuppressive therapy before or after~     the transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral~     stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.~   "
268501|NCT00053976|"~     The purpose of this study is to compare the effects of IL2 receptor antibody (also known as~     Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with~     corticosteroids is standard care for GVHD. This research is being done because the~     investigators do not know whether addition of this new medication to standard corticosteroid~     therapy improves response rates. Since Zenapax binds to a type of cell which is thought to~     cause GVHD and possibly inactivates them, investigators have reason to believe that addition~     of Zenapax night result in better control of GVHD This study will determine whether the~     addition of another medication, Zenapax, will be more effective than steroids alone in~     suppressing GVHD and improving symptoms of GVHD.~      Daclizumab (Zenapax) is approved by the Food and Drug Administration (FDA) for use in patient~     with kidney transplant to help prevent graft rejection. This medication has been used in bone~     marrow transplant patients to treat GVHD.~   "
268502|NCT00053963|"~     This phase I trial is studying the side effects and best dose of FR901228 in treating~     children with refractory or recurrent solid tumors or leukemia. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die~   "
268503|NCT00053950|"~     This phase I trial is studying the side effects and best dose of pyrazoloacridine given~     together with peripheral stem cell or bone marrow transplantation in treating young patients~     with high-risk neuroblastoma. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem~     cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy~     drugs and kill more tumor cells.~   "
268504|NCT00053937|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Pirfenidone may slow the growth or prevent further~     development of plexiform neurofibromas.~      PURPOSE: Phase I trial to study the effectiveness of pirfenidone in treating young patients~     who have neurofibromatosis type 1 and plexiform neurofibroma.~   "
268505|NCT00053924|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who~     have locally advanced or metastatic pancreatic cancer.~   "
268506|NCT00053911|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug, and giving them after surgery, may~     kill any remaining tumor cells following surgery. It is not yet known whether combination~     chemotherapy is more effective than observation in treating relapsed nonmetastatic breast~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with that of observation in treating women who have undergone surgery for relapsed~     nonmetastatic breast cancer.~   "
268507|NCT00053898|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight~     breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by~     decreasing estrogen production. It is not yet known whether anastrozole is more effective~     than tamoxifen in preventing the recurrence of breast cancer.~      PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works~     compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women~     with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.~   "
268508|NCT00053885|"~     RATIONALE: PTK787/ZK 222584 may stop the growth of tumor cells by blocking the enzymes~     necessary for tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of PTK787/ZK 222584 in treating patients~     with unresectable malignant mesothelioma.~   "
268509|NCT00053872|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Giving radiation therapy in different ways with combination chemotherapy may kill any~     remaining tumor cells following surgery. It is not yet known which radiation therapy regimen~     combined with combination chemotherapy is more effective in treating medulloblastoma.~      PURPOSE: Randomized phase III trial to compare different radiation therapy regimens plus~     combination chemotherapy in treating children who have undergone surgery for medulloblastoma.~   "
268510|NCT00053846|"~     RATIONALE: Buspirone may be effective in reducing dyspnea (shortness of breath) in patients~     with cancer who are undergoing chemotherapy.~      PURPOSE: Randomized clinical trial to study the effectiveness of buspirone in reducing~     shortness of breath in patients who are undergoing chemotherapy for cancer.~   "
268511|NCT00053833|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.~   "
268526|NCT00053638|"~     This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation~     containing two FDA-approved drugs in HIV-infected patients who have not received prior~     therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily~     regimen. Study physicians will evaluate subjects to determine if they have certain medical~     conditions, laboratory test values, medication use, or drug allergies that would exclude them~     from the study.~   "
268512|NCT00053820|"~     RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may~     stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     interferon alfa with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet~     known whether interferon alfa is more effective with or without interleukin-2 and~     fluorouracil in treating metastatic kidney cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined~     with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who~     have advanced metastatic kidney cancer.~   "
268513|NCT00053807|"~     RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may~     stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     interferon alfa and interleukin-2 with fluorouracil may kill any remaining tumor cells~     following surgery. It is not yet known whether combining interferon alfa and interleukin-2~     with fluorouracil is more effective than observation after surgery for kidney cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2,~     interferon alfa, and fluorouracil to that of observation alone in treating patients who have~     undergone surgery for kidney cancer and are at high risk of relapse.~   "
268514|NCT00053794|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who~     have metastatic or locally advanced soft tissue sarcoma.~   "
268515|NCT00053781|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who~     have metastatic or recurrent malignant melanoma.~   "
268516|NCT00053768|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug and giving the drugs in different~     ways may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer~     cells. It is not yet known which combination chemotherapy regimen followed by radiation~     therapy is more effective in treating aggressive non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens~     followed by radiation therapy to compare how well they work in treating patients with~     aggressive non-Hodgkin's lymphoma.~   "
268517|NCT00053716|"~     This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a~     vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure~     to treat or open up a blocked artery within one lower limb or the most affected of two limbs~     in subjects with Peripheral Arterial Occlusive Disease.~   "
268518|NCT00045123|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. R-flurbiprofen may be effective in delaying the recurrence of~     localized prostate cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating~     patients who have localized prostate cancer at risk of recurrence following radiation therapy~     and/or prostatectomy.~   "
268519|NCT00028678|"~     RATIONALE: Dalteparin may stop the growth of cancer by stopping blood flow to the tumor and~     by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy~     x-rays to damage tumor cells. Combining dalteparin with radiation therapy may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combining dalteparin with radiation~     therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.~   "
268520|NCT00017342|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 with cytarabine~     in treating patients who have relapsed primary acute myelogenous leukemia.~   "
268521|NCT00053742|"~     This study will test the safety of an experimental vaccine called modified vaccinia virus~     ankara (MVA) and determine if it confers protection against the smallpox virus (variola).~     There is an existing vaccine, called Dryvax® (Registered Trademark), which is effective~     against smallpox; however, this vaccine can cause various side effects, including some that,~     on rare occasions, can be life-threatening. Dryvax® (Registered Trademark) has not been used~     in the United States since childhood vaccination was stopped in 1971, and though it is given~     to certain healthcare and laboratory workers, and some people in the armed forces, it is not~     recommended for the general population. Both the MVA and Dryvax® (Registered Trademark)~     vaccines are made using the vaccinia virus, which is closely related to variola.~      Healthy normal volunteers between 31 and 60 years of age who have been vaccinated with a~     smallpox vaccine more than 10 years before entering the study may be eligible for this~     protocol. Candidates will be screened with a medical history, physical examination, and blood~     and urine tests, including an HIV test and a pregnancy test for women of childbearing~     potential.~      Participants will receive MVA vaccine or placebo, followed by a dose of Dryvax® (Registered~     Trademark). The MVA vaccine and placebo are injected into an arm muscle with a needle and~     syringe. The Dryvax® (Registered Trademark) vaccine is administered with a special forked~     needle that is poked lightly into the skin of the upper arm, usually 15 times, in a process~     called scarification. When the vaccine works, a small pus-filled blister forms, followed by a~     scab and then scarring at the site of the vaccination. The formation of the blister and scab~     is called a take, indicating that the vaccine is effective and will protect against smallpox~     for at least a few years. If scarification does not take, it can either mean that the person~     already has immunity or that the vaccine did not work.~      Study participants will be randomly assigned to one of the following dosing groups: 1) one~     injection of MVA; 2) one injection of placebo; 3) two injections of MVA 4 weeks apart; or 4)~     two injections of placebo 4 weeks apart. All participants will receive a challenge dose of~     Dryvax® (Registered Trademark) 12 weeks after their last injection of MVA or placebo to~     determine if the MVA vaccine has conferred immunity. A take, that occurs in response to the~     Dryvax® (Registered Trademark) dose indicates lack of prior immunity, and thus tells whether~     one or two doses of MVA is needed to produce an immune response.~      Participants will be observed for at least 1 hour after each injection. They will come to the~     clinic at least once a week after MVA or placebo injections and at least twice a week after~     Dryvax® (Registered Trademark) to have the injection site evaluated and photographed. At each~     visit, participants will be asked how they are feeling and what medications, if any, they are~     taking. Blood and urine tests will be done according to the following schedule:~        -  Before each injection;~        -  1 week after each injection;~        -  4 weeks after the MVA or placebo injections are finished;~        -  At the time of the Dryvax® (Registered Trademark) dose;~        -  4 weeks after the Dryvax® (Registered Trademark) dose;~        -  12 weeks after the Dryvax® (Registered Trademark) dose.~      Additional laboratory tests may be done between visits if medically necessary.~   "
268522|NCT00053703|"~     This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine~     (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with~     schizophrenia or schizoaffective disorder.~   "
268523|NCT00053690|"~     The purpose of this study is to develop an effective treatment for people with Post Traumatic~     Stress Disorder (PTSD) along with other mental illnesses.~   "
268524|NCT00053677|"~     This study will establish the best dose of the drug naltrexone to treat patients with~     Pathological Gambling Disorder (PGD) and severe urge symptoms.~   "
268525|NCT00053651|"~     This study will determine whether a prevention program reduces the incidence of postpartum~     depression in pregnant women who receive public assistance and are at risk for postpartum~     depression.~   "
268527|NCT00053625|"~     The purpose of this trial is to evaluate the effect of deep brain stimulation in the the~     globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and~     psychiatric function, and quality of life in patients with Parkinson's disease.~   "
268528|NCT00053612|"~     HIV infected individuals with vitamin A deficiency may be more likely to transmit the virus~     to others than HIV infected individuals who have normal levels of vitamin A. The presence of~     HIV DNA in vaginal secretions may indicate a greater risk for transmission of HIV to others.~     The purpose of this study is to determine if taking vitamin A decreases the level of HIV DNA~     in vaginal secretions.~   "
268529|NCT00053599|"~     CLASP is a research study to investigate the safety and effectiveness of simvastatin (a~     cholesterol lowering drug or statin) to slow the progression of Alzheimer's disease (AD).~     Statins are commonly used to treat high cholesterol levels, which increase the risk of heart~     disease and stroke.~   "
268530|NCT00053573|"~     Glycogen Storage Disease Type II (GSD-II; also known as Pompe disease) is caused by a~     deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally,~     GAA is used by the body's cells to break down glycogen (a stored form of sugar) within~     specialized structures called lysosomes. In patients with GSD-II, an excessive amount of~     glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle,~     which prevents their normal function. This study is being conducted to evaluate the safety~     and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme~     replacement therapy for GSD-II. Patients diagnosed with infantile-onset GSD-II who are~     greater than 6 months old, but less than or equal to 36 months old will be studied.~   "
268531|NCT00053560|"~     The purpose of this clinical trial is to study the effects of GL701 on bone mineral density~     in women with active systemic lupus erythematosus (SLE) who are also receiving treatment with~     glucocorticoids (e.g., prednisone).~   "
268532|NCT00053547|"~     The purpose of this study is to see if Zemplar, a vitamin D medication, safely and~     effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.~   "
268533|NCT00053534|"~     To monitor trends in congestive heart failure in Olmsted County, Minnesota.~   "
268534|NCT00053521|"~     To determine the role of genetic factors influencing risk factors for cardiovascular disease,~     ultimately identifying specific genes influencing the age-related progression of~     cardiovascular disease risks.~   "
268535|NCT00053508|"~     The purpose of this study is to examine the safety and the effectiveness of a new vaccine for~     the prevention of the disease, smallpox.~   "
268536|NCT00053495|"~     The purpose of this study is to examine the safety and the effectiveness of a new vaccine for~     the prevention of the disease, smallpox.~   "
268537|NCT00053482|"~     The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a~     cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age~     and previously vaccinated against smallpox.~   "
268538|NCT00053469|"~     This study will explore how babies become able to use their experience with objects to plan~     to manipulate them appropriately. For example, an adult knows that picking up a grocery bag~     full of canned food requires different actions than are needed for lifting an empty bag. This~     study will examine when and how infants first begin to adapt their actions to manipulate~     specific objects that weigh different amounts.~      Participants will include normal healthy babies within 2 weeks of their first birthday. If~     the expected results are obtained from testing, 9-month-old children will then be studied to~     identify a lower age boundary in task performance. If the expected results are not obtained~     at the 12-month test age, older children will be recruited to participate.~      The study involves one 30-minute session with the baby and his or her mother or father. The~     parent will answer some questions about the family, such as its size and ethnic make-up. The~     infant will then have small magnetic sensors taped to the underside of each arm and to the~     back. While sitting on the parent s lap, the infant will be presented with plastic toys, and~     his or her actions will be measured by the sensors as he or she reaches for and picks up the~     toys. The sensors will be connected to a computer that will track and record the motion of~     the infant s arms.~   "
268539|NCT00053456|"~     This study will look at the effect of a cardiac rehabilitation exercise program on release of~     stem cells from the bone marrow and on heart function. Stem cells are primitive cells~     produced and released by the bone marrow, circulate in the bloodstream and develop into white~     blood cells, red blood cells and platelets. Some stem cells may also develop into other kinds~     of cells, including those that make up heart muscle, especially if the heart has been damaged~     or is not getting sufficient blood. Stem cells called endothelial progenitor cells (EPCs) are~     thought to form new blood vessels that can carry blood to areas of the heart muscle that are~     oxygen-deprived because of clogged arteries. Previous experiments have shown that some EPCs~     can be forced out of the bone marrow by exercise. This study will examine whether repeated~     exercise and lifestyle changes increase the number of EPCs released into the bloodstream and~     if these cells improve heart and blood vessel function.~      Patients 21 years of age and older with coronary artery disease may be eligible for this~     study. Candidates will be screened with a medical history and physical examination, including~     a cardiovascular evaluation, and blood tests. The participants will be enrolled in a 2- to~     3-month cardiac rehabilitation program that includes 24 to 36 60-minute sessions of exercise,~     plus instruction on lifestyle changes related to diet, stress management, and relaxation~     techniques. In addition, participants will undergo the following tests and procedures:~        -  Brachial reactivity study: This test measures how well the arteries widen. The patients~          rest for 30 minutes, and then an ultrasound device is placed over the artery just above~          the elbow. The device measures the size of the artery and blood flow through it before~          and after the patient is given a spray of nitroglycerin under the tongue.~        -  Blood tests for EPC levels and genetic testing: These measure EPCs and determine whether~          certain genes that may regulate EPC function are turned on or off. Genes are made up of~          DNA, the molecules that lead to the production of proteins by cells. Some of these~          proteins may be important in releasing EPCs from the bone marrow to travel in the~          bloodstream to the heart and repair blood vessels and muscle cells.~        -  Treadmill exercise testing: Patients exercise on a treadmill with continuous monitoring~          of the heartbeat and frequent measurements of oxygen saturation, using a finger clip~          device. The patient continues to exercise until moderate chest pain, shortness of~          breath, or fatigue develops.~        -  Questionnaire: Patients fill out a 15-minute questionnaire about their general physical~          and mental health status at the first and last visits to the clinic.~        -  Magnetic resonance imaging (MRI) of the heart: Patients who are eligible to undergo MRI~          have this test twice during the study, once before beginning the rehabilitation program~          and again after completing the program. The MRI shows heart function and blood flow in~          the heart. For this test, the patient lies on a stretcher inside a long narrow cylinder~          (the scanner). During the scan, the drug dipyridamole, which increases blood flow to the~          heart, is infused into a vein of the hand or arm. Another drug, gadolinium, is also~          infused to brighten the images produced.~   "
268540|NCT00053443|"~     While anti-HIV drugs can significantly reduce viral loads, the medication regimens can be~     complex, and patients must take them correctly for the best effect. Nonadherent patients risk~     developing drug resistant HIV strains. The purpose of this study is to evaluate the~     effectiveness of a handheld computerized system designed to help patients take their drugs~     correctly.~   "
268541|NCT00053430|"~     Despite treatment with anti-HIV drugs, people infected with HIV continue to have problems~     with their immune systems. This study will evaluate whether the drug thalidomide, which~     stimulates the immune system's T cells, can improve immune system function in people with~     HIV.~   "
268542|NCT00053417|"~     Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central~     Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal~     cord, providing communication between the brain and the arms and legs. In people with MS, the~     fatty sheath that surrounds and insulates the nerve fibers (called myelin) deteriorates,~     causing nerve impulses to be slowed or stopped. As a result patients with MS may experience~     periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of~     coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the~     ability to think and/or remember. These periods of illness may come (exacerbations) and go~     (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases~     the ability of the nerve to conduct electrical impulses. This study will evaluate the effects~     of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the~     effects on muscle strength and spasticity. The study will also examine the possible risks of~     taking Fampridine-SR.~   "
268543|NCT00053404|"~     Drug resistant HIV strains often develop in patients who have taken anti-HIV drugs for an~     extended time. However, these drug resistant HIV strains do not always cause an increase in~     the level of HIV in the blood. This study will explore why some patients with drug resistant~     virus continue to have low viral loads.~   "
268544|NCT00053391|"~     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make~     the body build an immune response to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     who have stage III or stage IV melanoma.~   "
268546|NCT00053365|"~     Phase II trial to study the effectiveness of irofulven in treating patients who have~     recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die.~   "
268547|NCT00053352|"~     This phase III trial is studying surgery followed by combination chemotherapy to see how well~     it works in treating children with germ cell tumors that are not located in the head. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug, and giving them after surgery, may kill any~     remaining tumor cells following surgery. It is not yet known whether combination chemotherapy~     is effective in decreasing the recurrence of childhood germ cell tumors.~   "
268548|NCT00053339|"~     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Estrogen can~     stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast~     cancer by blocking the uptake of estrogen. Combining trastuzumab with tamoxifen may kill more~     tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of trastuzumab with or~     without trastuzumab in treating women who have invasive stage IV breast cancer.~   "
268549|NCT00053326|"~     This phase II trial is studying how well fenretinide works in treating children with~     recurrent or resistant neuroblastoma. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die.~   "
268550|NCT00053300|"~     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.~      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who~     have extensive-stage small cell lung cancer that has responded to previous chemotherapy.~   "
268551|NCT00053287|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping~     blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining fludarabine, carboplatin, and~     topotecan with thalidomide in treating patients who have relapsed or refractory acute myeloid~     leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes.~   "
268552|NCT00053261|"~     RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing~     treatment for cervical cancer.~      PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that~     occur in patients receiving treatment for cervical cancer and the effect these changes have~     on sexual function.~   "
268553|NCT00053248|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by~     blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib~     mesylate may kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with~     imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.~   "
268554|NCT00053235|"~     This research trial studies tissue samples from patients with ovarian cancer in the~     laboratory. Analyzing tissue samples from patients in the laboratory may help doctors learn~     more about cancer.~   "
268555|NCT00053222|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have locally advanced or metastatic pancreatic cancer that has not responded to~     gemcitabine.~   "
268556|NCT00053209|"~     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes~     necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     pemetrexed disodium with gemcitabine may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with~     gemcitabine in treating patients who have advanced cancer of the urothelium.~   "
268557|NCT00053196|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor~     bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells.~     It also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune system and help destroy any remaining cancer~     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor~     lymphocyte infusion) after the transplant may help increase this effect. Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving immunosuppressive therapy after the transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell~     transplant works in treating patients with relapsed hematologic cancer after treatment with~     chemotherapy and autologous stem cell transplant.~   "
268558|NCT00053183|"~     RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor~     to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor~     cells. Combining internal radiation with external-beam radiation therapy may kill any~     remaining tumor cells following surgery.~      PURPOSE: Phase I trial to study the effectiveness of combining internal radiation therapy~     with external-beam radiation therapy in treating patients who have undergone surgery for~     glioblastoma multiforme.~   "
268559|NCT00053157|"~     RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune~     cells found in bone marrow or peripheral blood and may help a person's immune system recover~     from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem~     cell donor and the patient may reduce the chance of developing graft-versus-host disease~     following stem cell transplantation.~      PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing~     graft-versus-host disease in patients who are undergoing donor stem cell transplantation for~     hematologic cancer or aplastic anemia.~   "
268560|NCT00053144|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with cytarabine in~     treating patients who have refractory or recurrent acute myeloid leukemia or chronic~     myelogenous leukemia.~   "
268561|NCT00053131|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Colony-stimulating factors such as filgrastim and sargramostim~     may increase the number of immune cells found in bone marrow or peripheral blood and may help~     a person's immune system recover from the side effects of chemotherapy. It is not yet known~     whether combination chemotherapy is more effective followed by filgrastim or sargramostim in~     treating leukemia.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy~     followed by filgrastim with that of combination chemotherapy followed by sargramostim in~     treating patients who have relapsed or refractory acute myeloid leukemia or acute~     lymphoblastic leukemia.~   "
268562|NCT00053118|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with peripheral~     stem cell transplantation in treating children who have central nervous system cancer.~   "
268563|NCT00053105|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when~     treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.~   "
268564|NCT00053092|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells~     and either kill them or deliver cancer-killing substances to them without harming normal~     cells. It is not yet known if combination chemotherapy is more effective with or without~     rituximab in treating mantle cell lymphoma.~      PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and~     cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in~     treating patients who have mantle cell lymphoma.~   "
268565|NCT00053053|"~     RATIONALE: Nutritional supplements may help prevent loss of appetite, weight loss, and~     fatigue in patients with advanced cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two nutritional~     supplements in preventing loss of appetite, weight loss, and fatigue in patients who have~     stage III or stage IV solid tumors.~   "
268566|NCT00053040|"~     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of immunotoxin~     therapy and to see how well it works in treating children undergoing surgery for recurrent or~     progressive malignant glioma.~   "
268567|NCT00053027|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy such as cladribine work in different ways to stop cancer cells from dividing so~     they stop growing or die. Combining rituximab with cladribine may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving rituximab together with cladribine~     works in treating patients with newly-diagnosed mantle cell lymphoma.~   "
268568|NCT00053014|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an~     immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may~     prevent this from happening.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation~     followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate~     mofetil in treating older patients who have acute myeloid leukemia.~   "
268569|NCT00053001|"~     RATIONALE: Thalidomide may stop or slow the growth of cancer cells. Epoetin alfa may~     stimulate red blood cell production. Combining thalidomide with epoetin alfa may improve~     anemia, decrease the need for blood transfusions, and improve the quality of life in patients~     with myelodysplastic syndrome.~      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with epoetin alfa~     in treating anemia in patients who have myelodysplastic syndrome.~   "
268570|NCT00041275|"~     RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using megestrol~     may fight liver cancer by blocking the uptake of estrogen. It is not yet known if megestrol~     is an effective treatment for liver cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating~     patients who have liver cancer that cannot be removed by surgery.~   "
268571|NCT00004078|"~     This phase II trial is studying irinotecan to see how well it works in treating children with~     refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die.~   "
268572|NCT00003830|"~     RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help~     plan more effective surgery for breast cancer. It is not yet known if surgery to remove the~     sentinel lymph nodes is more effective with or without removal of the lymph nodes in the~     armpit in treating breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the~     sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women~     who have breast cancer.~   "
268573|NCT00052962|"~     This study will determine which of the two following treatment regimens provides greater~     benefit to patients with peritoneal carcinomatosis (gastrointestinal cancer that has spread~     throughout the abdomen):~        -  Surgical removal of tumors plus heated chemotherapy during surgery, followed by one dose~          of chemotherapy 7 to 12 days after surgery, followed 3 weeks later by 4 months of~          chemotherapy; or~        -  Surgical removal of tumors followed by 4 months of chemotherapy, starting 1 month after~          surgery.~      Patients 18 years of age and older with peritoneal carcinomatosis may be eligible for this~     study. Candidates are screened with a medical history, physical examination, and blood tests;~     chest X-ray and computed tomography (CT) scans; review of pathology slides; electrocardiogram~     (EKG), bone scan, and brain magnetic resonance imaging (MRI), as needed; and laparotomy.~     Laparatomy is a surgical procedure in which an incision is made in the abdomen to look at the~     amount and location of tumors in the abdominal cavity. Patients whose surgery reveals that~     the tumors cannot be removed are taken off study. Those eligible for the study have their~     tumors removed during this screening laparotomy as part of the study procedure, as follows:~      All participants undergo laparotomy and removal of as much tumor as possible, as described~     above. Patients are then randomly assigned to one of two treatment groups:~        -  Group 1 - During laparotomy, after tumor removal, patients receive continuous~          hyperthermic peritoneal perfusion (CHPP) with the anti-cancer drug cisplatin. For CHPP,~          the cisplatin solution is heated and delivered to the abdomen through a catheter~          (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the~          body through another catheter. At the close of surgery, a small catheter, called a~          Tenckhoff catheter, is left in the abdomen and brought out through the skin. Between~          days 7 and 12 after surgery, one dose of fluorouracil and paclitaxel chemotherapy is~          delivered through this catheter. The catheter is removed following complete recovery~          from surgery and the patient is discharged from the hospital. Four to 6 weeks after the~          surgery, patients have CT scans of the chest, pelvis, and abdomen, and then begin~          intravenous (IV, through a vein) chemotherapy with oxaliplatin, 5-fluorouracil (5-FU),~          and leucovorin. The chemotherapy is given in 4-week courses as follows: oxaliplatin on~          day 1, infused over 2 hours through a vein in the arm or neck; leucovorin on days 1 and~          2, infused over 2 hours, followed by 5-fluorouracil over 22 hours; leucovorin and 5-FU~          repeated two weeks later on days 15 and 16. This regimen is repeated two weeks later.~          Between each week of chemotherapy is a week break. A course of chemotherapy consists of~          28 days (two weeks of chemotherapy and two 1-week breaks). Patients may receive up to~          four courses (total of 16 weeks) unless their disease progresses or they cannot tolerate~          further doses. Doses of the chemotherapy can be reduced if the side effects are too~          severe.~        -  Group 2 - Patients follow the same procedure as those in Group 1 for laparotomy, CT~          imaging, and IV chemotherapy with oxaliplatin, 5-fluorouracil, and leucovorin. They do~          not receive CHPP or chemotherapy into the abdomen.~      All patients undergo repeat imaging tests six weeks after surgery and at the conclusion of~     the intravenous (IV) chemotherapy. They return for a physical examination and CT scans every~     three months for the first year, every four months for the next two years, and then every six~     months for up to five years after treatment. They are also asked to complete quality of life~     questionnaires before and after surgery, at the completion of chemotherapy, and at every~     follow-up visit.~   "
268574|NCT00052949|"~     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have~     recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by~     blocking the enzymes necessary for cancer cell growth.~   "
268575|NCT00052936|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. It is not yet known whether combination chemotherapy is more effective with or without~     rituximab in treating aggressive non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide,~     doxorubicin, vincristine, and prednisone together with or without rituximab works in treating~     older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer~     randomized as of 6/2005).~   "
271304|NCT00034762|"~     The purpose of this study is to evaluate the efficacy and safety of risperidone compared with~     placebo in the treatment of psychotic symptoms in patients with Alzheimer's disease~   "
268576|NCT00052923|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~     Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. It is not yet known~     whether stem cell transplantation is more effective with or without rituximab in treating~     relapsed or progressive B-cell diffuse large cell lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of stem cell transplantation~     with or without rituximab in treating patients who have relapsed or progressive B-cell~     diffuse large cell lymphoma.~   "
268577|NCT00052910|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor~     cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen~     is more effective in treating stomach or esophageal cancer.~      PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation~     therapy regimens in treating patients who have undergone surgery for stomach or esophageal~     cancer.~   "
268578|NCT00052897|"~     Phase I/II trial to study the effectiveness of SGN-00101 in preventing anal cancer in~     HIV-positive patients who have high-grade anal neoplasia. Chemoprevention therapy is the use~     of certain drugs to try to prevent the development of cancer. SGN-00101 may be effective in~     preventing anal cancer.~   "
268579|NCT00052884|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma~     cells, either by killing the cells or by stopping them from dividing. Having a peripheral~     stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows~     higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a~     chemoprotective drug such as amifostine may protect kidney cells from the side effects of~     chemotherapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given~     together with amifostine in treating patients who are undergoing peripheral stem cell~     transplant for primary systemic amyloidosis.~   "
268580|NCT00052845|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may~     fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth~     of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining these~     therapies may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind~     and docetaxel in treating patients who have metastatic prostate cancer that has not responded~     to hormone therapy.~   "
268581|NCT00052832|"~     RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood~     transfusions and may be an effective treatment for myelodysplastic syndrome or chronic~     myelomonocytic leukemia.~      PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients~     who have myelodysplastic syndrome or chronic myelomonocytic leukemia.~   "
268582|NCT00052780|"~     Phase I trial to study the safety of combining O6-benzylguanine with temozolomide in treating~     children who have recurrent or refractory brain tumors. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die.~     O6-benzylguanine may increase the effectiveness of temozolomide by making tumor cells more~     sensitive to the drug.~   "
268583|NCT00052754|"~     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor~     cells and slow the growth of synovial sarcoma.~      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have~     locally advanced or metastatic synovial sarcoma.~   "
268584|NCT00052728|"~     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary~     for tumor cell growth. Tamoxifen may fight breast cancer by blocking the use of estrogen.~     Combining tipifarnib with tamoxifen may be effective treatment for metastatic breast cancer.~      PURPOSE: This phase II trial is studying how well giving tipifarnib together with tamoxifen~     works in treating women with metastatic breast cancer.~   "
268585|NCT00052715|"~     RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune~     system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation~     therapy in treating patients who have newly diagnosed glioblastoma multiforme.~   "
268586|NCT00052689|"~     Randomized phase II trial to compare the effectiveness of bortezomib with or without~     gemcitabine in treating patients who have metastatic pancreatic cancer. Bortezomib may stop~     the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used~     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining bortezomib with gemcitabine may kill more tumor cells.~   "
268587|NCT00052676|"~     RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue~     dye near the tumor is more effective than injecting them near the nipple in identifying~     sentinel lymph nodes in patients with stage I or stage II breast cancer.~      PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc~     99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in~     detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.~   "
268588|NCT00052637|"~     RATIONALE: Diagnostic procedures such as cystoscopy may improve the ability to detect cancer~     and to determine the extent of disease.~      PURPOSE: Diagnostic trial to compare the effectiveness of cystoscopy using hexyl~     5-aminolevulinate and two light sources in detecting carcinoma in situ in patients who have~     bladder cancer.~   "
268589|NCT00052624|"~     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.~     Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic~     astrocytoma.~      PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating children~     who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma~   "
271305|NCT00034749|"~     A clinical study to compare the safety and effectiveness of two different dose ranges of~     risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.~   "
268590|NCT00052611|"~     Patient at increased risk for developing a new head and neck squamous cell carcinoma are~     invited to take part in this study.~      The investigators of this trial will attempt to study the effectiveness of Celecoxib in~     preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.~   "
268591|NCT00052598|"~     This phase I/II trial is studies the side effects of giving therapeutic allogeneic~     lymphocytes together with aldesleukin and to see how well it works in treating patients with~     high-risk or recurrent myeloid leukemia after undergoing donor stem cell transplant.~     Biological therapies, such as therapeutic autologous lymphocytes, may stimulate the immune~     system in different ways and stop cancer cells from growing. Aldesleukin may stimulate the~     white blood cells to kill cancer cells. Giving therapeutic autologous lymphocytes together~     with aldesleukin may kill more cancer cells~   "
268592|NCT00052585|"~     Phase II trial to study the effectiveness of combining gefitinib with fluorouracil,~     leucovorin, and irinotecan in treating patients who have advanced or recurrent colorectal~     cancer. Biological therapies such as gefitinib may stop the growth of tumor cells by blocking~     the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die. Combining gefitinib with~     fluorouracil, leucovorin, and irinotecan may kill more tumor cells~   "
268593|NCT00052572|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who~     have relapsed or refractory lymphoproliferative disorders.~   "
268594|NCT00052559|"~     This phase I trial is studying the side effects and best dose of bevacizumab when given~     together with fluorouracil and external-beam radiation therapy in treating patients with~     stage II or stage III rectal cancer. Monoclonal antibodies, such as bevacizumab, can block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or deliver cancer-killing substances to them.~     Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they~     stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining monoclonal antibody therapy with chemotherapy and radiation therapy may kill more~     tumor cells.~   "
268595|NCT00052520|"~     This phase I/II trial is studying the side effects of biological therapy and to see how well~     it works in treating patients with advanced myelodysplastic syndrome, chronic myeloid~     leukemia, acute myeloid leukemia, or acute lymphoblastic leukemia. Biological therapies,~     including immunotherapy, can potentially be used to stimulate the immune system and stop~     cancer cells from growing. Immunotherapy given to patients who have undergone donor stem cell~     transplantation may be a way to eradicate remaining cancer cells~   "
268596|NCT00052507|"~     RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes~     necessary for cancer cell growth.~      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who~     have metastatic or recurrent colorectal cancer.~   "
268597|NCT00052494|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by~     blocking the enzymes necessary for their growth. Combining more than one chemotherapy drug~     with imatinib mesylate may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining cisplatin, irinotecan, and~     imatinib mesylate in treating patients who have extensive-stage small cell lung cancer.~   "
268598|NCT00052481|"~     RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may~     help determine the intermediate-term and long-term effects of surgery and brachytherapy.~      PURPOSE: Randomized clinical trial to study quality of life in patients undergoing radical~     prostatectomy or brachytherapy for stage II prostate cancer.~   "
268599|NCT00052468|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than~     carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.~      PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with~     gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating~     patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.~   "
268600|NCT00052455|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of chemotherapy is more effective in treating recurrent malignant~     glioma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of temozolomide alone to~     that of procarbazine, lomustine, and vincristine in treating patients who have recurrent~     malignant glioma.~   "
268601|NCT00052442|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in~     treating patients who have recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's~     lymphoma.~   "
268602|NCT00052429|"~     RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may~     kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     high-dose radiation with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy~     with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage~     IV nasopharyngeal cancer.~   "
268603|NCT00052416|"~     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.~      PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who~     have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.~   "
268604|NCT00052403|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have advanced solid tumors.~   "
271306|NCT00034736|"~     The purpose of this study is to determine the safety and efficacy of levofloxacin in the~     treatment of children with community acquired pneumonia.~   "
268605|NCT00052390|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Bevacizumab may stop the growth of tumor cells by stopping blood~     flow to the tumor. Combining doxorubicin with bevacizumab may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin with bevacizumab~     in treating patients who have locally recurrent or metastatic soft tissue sarcoma.~   "
268606|NCT00052377|"~     Phase I/II trial to study the effectiveness of combining interleukin-12 with interleukin-2 in~     treating patients who have mycosis fungoides. Biological therapies, such as interleukin-12~     and interleukin-2, use different ways to stimulate the immune system and stop cancer cells~     from growing. Combining more than one biological therapy may kill more tumor cells~   "
268607|NCT00052364|"~     Phase II trial to study the effectiveness of oxaliplatin in treating patients who have~     unresectable, recurrent or metastatic liver cancer. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die.~   "
268608|NCT00052351|"~     RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune~     response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase~     the number of immune cells found in bone marrow or peripheral blood. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining vaccine therapy with sargramostim and chemotherapy may kill more tumor cells.~      PURPOSE: Randomized clinical trial to study the effectiveness of vaccine therapy plus~     sargramostim and combination chemotherapy in treating women who have undergone surgery for~     stage II or stage III breast cancer that has spread to the lymph nodes.~   "
268609|NCT00052338|"~     Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer~     cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die. Combining more than one chemotherapy drug and bortezomib may~     kill more tumor cells~   "
268610|NCT00052325|"~     RATIONALE: Mistletoe may help the body build an immune response and may improve quality of~     life to help patients live more comfortably.~      PURPOSE: This phase II trial is studying mistletoe to see how well it works in treating~     patients who are receiving palliative chemotherapy for stage IIIB or stage IV non-small cell~     lung cancer.~   "
268611|NCT00052312|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~     It is not yet known whether doxorubicin and cisplatin are more effective with or without~     paclitaxel in treating endometrial cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and~     cisplatin with or without paclitaxel in treating patients who have locally advanced,~     metastatic, and/or relapsed endometrial cancer.~   "
268612|NCT00052299|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. It is not yet~     known if combining combination chemotherapy with monoclonal antibody therapy will kill more~     cancer cells.~      PURPOSE: Randomized phase III trial to determine the effectiveness of combination~     chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute~     myeloid leukemia.~   "
268613|NCT00052286|"~     RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes~     such as memory loss in patients who have undergone treatment for primary brain cancer. The~     effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet~     known.~      PURPOSE: This randomized clinical trial is comparing how well two different doses of~     modafinil work in treating fatigue and behavioral changes in patients who have undergone~     treatment for primary brain cancer.~   "
268614|NCT00052273|"~     RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for~     cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     LY317615 with capecitabine may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in~     treating patients who have advanced solid tumors.~   "
268615|NCT00052221|"~     RATIONALE: Epoetin alfa may help improve energy levels and quality of life in patients who~     have advanced solid tumors.~      PURPOSE: Randomized clinical trial to study the effectiveness of epoetin alfa in treating~     fatigue in patients who are not receiving chemotherapy for advanced solid tumors.~   "
268616|NCT00052208|"~     This phase I/II trial studies the side effects and best dose of gefitinib when given together~     with radiation therapy and to see how well it works in treating patients with glioblastoma~     multiforme. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving~     gefitinib together with radiation therapy may be an effective treatment for glioblastoma~     multiforme.~   "
268617|NCT00052195|"~     A significant number of HIV infected patients in Africa also have disseminated tuberculosis~     (infection throughout multiple organs). This type of tuberculosis is a significant cause of~     mortality in these patients. The purpose of this study is to evaluate the safety and~     effectiveness of a vaccine designed to prevent disseminated tuberculosis.~   "
268618|NCT00052182|"~     HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have~     weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost~     the immune system's responses against many HIV-1 proteins. The main purposes of this study~     are to test the safety of this HIV vaccine (EP HIV-1090) and to test whether the vaccine can~     stimulate immune system responses in people who have HIV-1 infection.~   "
268619|NCT00052169|"~     The purpose of this study is to learn how breast cancer tumors respond to treatment combining~     the drugs docetaxel and ZD1839.~   "
268620|NCT00049712|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have refractory advanced solid tumors or lymphoma.~   "
268621|NCT00049699|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have~     advanced or metastatic cancer.~   "
268622|NCT00049686|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have~     relapsed or refractory leukemia or myelodysplastic syndrome.~   "
268623|NCT00049673|"~     RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the~     tumor. It is not yet known whether combining thalidomide with prednisone and giving them~     after autologous stem cell transplantation may be effective in treating multiple myeloma.~      PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how~     well they work compared to observation in treating patients who have undergone stem cell~     transplantation for multiple myeloma.~   "
268624|NCT00049660|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if capecitabine is more effective than~     vinorelbine in treating metastatic breast cancer.~      PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that~     of vinorelbine in treating women who have metastatic breast cancer that has been previously~     treated with chemotherapy.~   "
268625|NCT00049634|"~     RATIONALE: Giving chemotherapy drugs before a donor peripheral blood stem cell transplant~     helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system~     from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused~     into the patient they may help the patient's bone marrow make stem cells, red blood cells,~     white blood cells, and platelets. Giving colony-stimulating factors, such as G-CSF, to the~     donor helps the stem cells move from the bone marrow to the blood so they can be collected~     and stored.~      PURPOSE: This phase I/II trial is studying how well donor peripheral stem cell transplant~     works in treating patients with myelodysplastic syndrome, acute myeloid leukemia, or~     myeloproliferative disorder.~   "
268626|NCT00049608|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor~     cells from dividing so they stop growing or die. Mistletoe may slow the growth of tumor cells~     and may be an effective treatment for solid tumors.~      PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine with mistletoe in~     treating patients who have advanced solid tumors.~   "
268627|NCT00049595|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which combination chemotherapy regimen is more effective in treating stage III~     or stage IV Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.~   "
268628|NCT00049582|"~     This phase I trial is studying the side effects and best dose of decitabine in treating~     patients with myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die.~   "
268629|NCT00049569|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes~     necessary for cancer cell growth. Combining more than one chemotherapy drug with imatinib~     mesylate may kill more cancer cells. Randomized phase II trial to study the effectiveness of~     combination chemotherapy and imatinib mesylate in treating children who have relapsed acute~     lymphoblastic leukemia.~   "
268630|NCT00049556|"~     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor~     cells and slow the growth of cervical cancer. Comparing results of diagnostic procedures~     performed before, during, and after treatment with gefitinib may help doctors predict a~     patient's response to treatment and help plan the most effective treatment.~      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with~     cervical cancer.~   "
268631|NCT00049543|"~     This randomized phase III trial studies how well gefitinib works in treating patients with~     stage IB, II, or IIIA non-small cell lung cancer that was completely removed by surgery.~     Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It is not yet known if gefitinib may be an effective treatment in preventing tumors~     from returning after they have been removed by surgery.~   "
268632|NCT00049530|"~     RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping~     blood flow to the tumor.~      PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating~     patients who have stage IV melanoma.~   "
268633|NCT00049517|"~     RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the~     growth of cancer cells. It also helps stop the patient's immune system from rejecting the~     transplanted stem cells. When the healthy stem cells are infused into the patient they may~     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets. If the patient's stem cells are to be transplanted, the patient is also treated~     with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells~     or deliver cancer-killing substances to them without harming normal cells. It is not yet~     known whether combination chemotherapy is more effective with or without gemtuzumab~     ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab~     ozogamicin, and stem cell transplant to see how well they work compared to combination~     chemotherapy and peripheral stem cell transplant alone in treating patients with acute~     myeloid leukemia.~   "
268634|NCT00049504|"~     This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide,~     tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone~     marrow transplant works in treating patients with high-risk hematologic cancer. Giving low~     doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body~     irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by~     stopping them from dividing or killing them. Giving cyclophosphamide after transplant may~     also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The~     donated stem cells may replace the patient's immune system cells and help destroy any~     remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a~     donor can also make an immune response against the body's normal cells. Giving tacrolimus and~     mycophenolate mofetil after the transplant may stop this from happening~   "
268635|NCT00049465|"~     RATIONALE: Telephone counseling by trained counselors may enhance the well-being and quality~     of life of patients who have undergone stem cell transplantation for cancer.~      PURPOSE: Randomized clinical trial to compare the effectiveness of standard follow-up care~     with extended follow-up care in treating patients who have undergone stem cell~     transplantation for cancer.~   "
268636|NCT00049452|"~     RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in~     premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for~     early stage breast cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in~     preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for~     early stage breast cancer.~   "
268637|NCT00049439|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining lomustine, etoposide,~     cyclophosphamide, and procarbazine in treating patients who have AIDS-related non-Hodgkin's~     lymphoma.~   "
268638|NCT00049413|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Combining~     chemotherapy with monoclonal antibody therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and~     cyclophosphamide with rituximab in treating patients who have chronic lymphocytic leukemia or~     lymphocytic lymphoma.~   "
268639|NCT00049400|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in~     treating patients with advanced solid tumors or lymphomas and liver dysfunction.~   "
268640|NCT00049387|"~     This phase I trial is studying the side effects and best dose of tipifarnib when given~     together with temozolomide and radiation therapy in treating patients with newly diagnosed~     glioblastoma multiforme or gliosarcoma. Tipifarnib may stop the growth of tumor cells by~     blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Combining tipifarnib, temozolomide, and radiation therapy may kill more tumor~     cells.~   "
268641|NCT00049374|"~     RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the~     effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the~     drugs.~      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone~     with oblimersen in treating patients who have relapsed or refractory multiple myeloma.~   "
268642|NCT00049361|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining~     whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy~     with thalidomide and temozolomide in treating patients who have newly diagnosed brain~     metastases.~   "
268643|NCT00049348|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it~     can be removed during surgery.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens~     combining chemotherapy with radiation therapy in treating patients who are undergoing surgery~     for locally advanced pancreatic cancer.~   "
268644|NCT00049335|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating older patients~     who have metastatic or recurrent colorectal cancer that cannot be surgically removed.~   "
268645|NCT00049322|"~     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, cisplatin, and~     mitomycin, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking~     the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Monoclonal~     antibodies, such as bevacizumab, can kill any tumor cells that are left after~     chemoembolization by blocking their ability to grow and spread.~      PURPOSE: This randomized phase II trial is studying to see if chemoembolization followed by~     bevacizumab works better than chemoembolization alone in treating patients who have liver~     cancer that cannot be removed with surgery.~   "
268646|NCT00049309|"~     RATIONALE: A diet that is low in fat and/or high in flaxseed may slow or prevent disease~     progression of prostate cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of a diet that is low in fat~     and/or high in flaxseed in slowing or preventing disease progression in patients who have~     newly diagnosed prostate cancer.~   "
268647|NCT00049296|"~     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Combining thalidomide with docetaxel may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in~     treating patients who have advanced cancer.~   "
268648|NCT00049283|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes~     necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor~     cells. Combining erlotinib with docetaxel may make the tumor cells more sensitive to~     radiation therapy and may kill more tumor cells. Phase I trial to study the maximum tolerated~     dose (MTD) of combining erlotinib with docetaxel and radiation therapy in treating patients~     who have locally advanced head and neck cancer~   "
268664|NCT00049023|"~     RATIONALE: Radiolabeled octreotide can locate tumor cells and deliver radioactive~     tumor-killing substances to them without harming normal cells.~      PURPOSE: This phase I trial is to study the safety and effectiveness of radiolabeled~     octreotide in treating children who have advanced or refractory solid tumors.~   "
268649|NCT00049257|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin~     in treating patients who have metastatic prostate cancer that has not responded to hormone~     therapy.~   "
268650|NCT00049244|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine~     in treating patients who have metastatic breast cancer that has not responded to previous~     chemotherapy with a taxane and an anthracycline.~   "
268651|NCT00049231|"~     RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of~     anticancer therapy. EF5 may be effective in measuring oxygen in tumor tissue and helping to~     predict the effectiveness of anticancer therapy.~      PURPOSE: Diagnostic trial to study the effectiveness of EF5 in detecting tumor hypoxia in~     patients who have stage IIB, stage IIIB, or stage IVA cervical cancer.~   "
268652|NCT00049218|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Vaccines made from a gene-modified virus may make the body build an~     immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill~     more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by adenovirus~     p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer.~   "
268653|NCT00049192|"~     Phase II trial to study the effectiveness of combining oblimersen with imatinib mesylate in~     treating patients who have chronic myelogenous leukemia that has not responded to previous~     treatment with imatinib mesylate. Imatinib mesylate may stop the growth of cancer cells by~     blocking the enzymes necessary for cancer cell growth. Oblimersen may help imatinib mesylate~     kill more cancer cells by making cancer cells more sensitive to the drug.~   "
268654|NCT00049179|"~     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from~     dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may~     kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with~     cytarabine in treating patients who have relapsed acute myeloid leukemia.~   "
268655|NCT00049166|"~     Phase I trial to study the effectiveness of combining erlotinib with radiation therapy with~     or without cisplatin in treating patients who have advanced mouth or throat cancer. Erlotinib~     may stop the growth of tumor cells by blocking the enzymes necessary for their growth.~     Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die. Combining~     erlotinib with radiation therapy with or without cisplatin may kill more tumor cells.~   "
268656|NCT00049140|"~     RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor~     cells may help to plan effective treatment for solid tumors.~      PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods~     of detecting oxygen levels in tumor cells of patients who have head and neck cancer.~   "
268657|NCT00049127|"~     This phase I/II trial is studying the side effects and best dose of imatinib mesylate and to~     see how well it works in treating patients with a recurrent brain tumor that has not~     responded to previous surgery and radiation therapy. Imatinib mesylate may stop the growth of~     tumor cells by blocking the enzymes necessary for tumor cell growth.~   "
268658|NCT00049114|"~     Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways~     to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth~     of tumor cells by blocking the enzymes necessary for their growth. Combining tipifarnib with~     doxorubicin and cyclophosphamide may kill more tumor cells. Phase II trial to study the~     effectiveness of combining tipifarnib with doxorubicin and cyclophosphamide in treating women~     who have locally advanced breast cancer.~   "
268659|NCT00049101|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the~     enzymes necessary for tumor cell growth. Combining erlotinib with combination chemotherapy~     may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib with oxaliplatin,~     leucovorin, and fluorouracil in treating patients who have metastatic colorectal cancer.~   "
268660|NCT00049088|"~     Phase I trial to study the effectiveness of combining bortezomib with docetaxel in treating~     patients who have advanced solid tumors. Bortezomib may stop the growth of tumor cells by~     blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     bortezomib with docetaxel may kill more tumor cells~   "
268661|NCT00049075|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who~     have chronic lymphocytic leukemia that has not been previously treated.~   "
268662|NCT00049062|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight~     breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies~     such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of~     advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in~     treating postmenopausal women who have metastatic breast cancer that has not responded to~     hormone therapy.~   "
268663|NCT00049036|"~     This randomized phase II trial is studying how well giving combination chemotherapy together~     with rituximab works in treating patients with HIV-associated stage I, stage II, stage III,~     or stage IV non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop~     cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as~     rituximab can locate cancer cells and either kill them or deliver cancer-killing substances~     to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy~     may kill more cancer cells.~   "
268665|NCT00049010|"~     RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node~     samples may help doctors identify patients with melanoma who are at risk for developing~     metastatic cancer.~      PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well~     they work in predicting the development of metastatic cancer in patients with stage I or~     stage II melanoma.~   "
268666|NCT00048997|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known if giving radiation therapy to the head is effective in preventing CNS metastases in~     patients who have stage III non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head~     works in preventing CNS metastases in patients who have been previously treated for stage III~     non-small cell lung cancer.~   "
268667|NCT00048984|"~     Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma. Genetic~     testing may help predict how cancer will respond to treatment and allow doctors to plan more~     effective therapy.~   "
268668|NCT00048971|"~     RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs~     and may help doctors plan more effective treatment with fewer side effects.~      PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients~     with stage III colon cancer who are receiving chemotherapy.~   "
268669|NCT00048958|"~     Chromosomal analysis or the study of genetic differences in patients previously untreated~     with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It~     may also improve the ability to predict the course of disease and the selection of therapy.~     Institutions must have either an Alliance-approved cytogeneticist or an agreement from an~     Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The~     Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical~     Trials in Oncology website.~   "
268670|NCT00047385|"~     RATIONALE: Effective screening tests should help doctors detect lung cancer early and plan~     curative treatment. It is not yet known whether low-dose helical computed tomography (LDCT)~     screening is more effective than chest radiography (CXR) screening in reducing death from~     lung cancer.~      PURPOSE: Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR~     in screening individuals who are at high risk for developing lung cancer.~   "
268671|NCT00047346|"~     Phase I trial to study the effectiveness of erlotinib in treating patients who have~     unresectable liver cancer and liver dysfunction. Biological therapies such as erlotinib may~     interfere with the growth of tumor cells and slow the growth of the tumor~   "
268672|NCT00047333|"~     Phase II trial to study the effectiveness of erlotinib in treating patients who have liver~     cancer that cannot be surgically removed. Erlotinib may stop the growth of tumor cells by~     blocking the enzymes necessary for their growth~   "
268673|NCT00047320|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink~     the tumor so that it is no longer present by conventional imaging and tumor markers from~     serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor~     cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill~     more tumor cells.~      PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without~     surgery and with or without high dose chemotherapy and peripheral stem cell transplantation,~     can increase response rates prior to radiation therapy and increase progression free and~     overall surviving patients with newly diagnosed intracranial germ cell tumors.~   "
268674|NCT00047307|"~     Drugs used in chemotherapy work different ways to stop tumor cells from dividing so they stop~     growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Flavopiridol~     may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the~     effectiveness of combining flavopiridol with radiation therapy followed by gemcitabine~     hydrochloride in treating patients who have locally advanced, unresectable pancreatic cancer.~   "
268675|NCT00047294|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by~     stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making~     tumor cells more sensitive to the drug.~      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide, thalidomide,~     and celecoxib following radiation therapy in treating patients who have newly diagnosed~     glioblastoma multiforme.~   "
268676|NCT00047281|"~     RATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood~     flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and~     cyclophosphamide may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib~     with etoposide and cyclophosphamide in treating patients who have relapsed or refractory~     malignant glioma.~   "
268677|NCT00047268|"~     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. It is not yet known whether donor stem cell~     transplant is more effective with or without chemotherapy in treating primary myelodysplastic~     syndrome.~      PURPOSE: This phase III trial is studying how well donor stem cell transplant given with~     chemotherapy works and compares it with donor stem cell transplant without chemotherapy in~     treating children with primary myelodysplastic syndrome.~   "
268678|NCT00047255|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. It is not yet known if docetaxel and trastuzumab are more effective with or without~     carboplatin in treating women who have HER2-positive breast cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of combining docetaxel and~     trastuzumab with or without carboplatin in treating women who have HER2-positive stage IIIB~     or stage IV breast cancer.~   "
268679|NCT00047242|"~     RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in~     treating patients who have advanced solid tumors.~   "
268680|NCT00047229|"~     RATIONALE: Drugs used in chemotherapy such as doxorubicin use different ways to stop tumor~     cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of~     doxorubicin by making tumor cells more sensitive to the drug.~      PURPOSE: Phase II trial to study the effectiveness of combining oblimersen with doxorubicin~     in treating patients who have locally advanced, recurrent, or metastatic hepatocellular~     carcinoma (liver cancer).~   "
268681|NCT00047216|"~     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary~     for tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who~     have recurrent bladder cancer.~   "
268682|NCT00047203|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Phase II trial to study the effectiveness of flavopiridol in treating~     patients who have relapsed or refractory multiple myeloma~   "
268683|NCT00047190|"~     Phase II trial to study the effectiveness of tipifarnib in treating patients who have~     myelofibrosis with myeloid metaplasia. Tipifarnib may stop the growth of tumor cells by~     blocking the enzymes necessary for tumor cell growth.~   "
268684|NCT00047177|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating children who~     have recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal or~     atypical teratoid rhabdoid tumor.~   "
268685|NCT00047164|"~     RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can~     locate cancer cells and either kill them or deliver cancer-killing substances to them without~     harming normal cells.~      PURPOSE: This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4~     monoclonal antibody to see how well it works in treating patients with lymphoma or colon~     cancer that has not responded to vaccine therapy.~   "
268686|NCT00047138|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor~     so it can be removed during surgery. Giving more chemotherapy after surgery may kill any~     remaining tumor cells. It is not yet known which chemotherapy regimen after surgery is most~     effective in treating Wilm's tumor.~      PURPOSE: Phase III trial to study the effectiveness of chemotherapy before and after surgery~     in treating children who have Wilm's tumor.~   "
268687|NCT00047125|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     therapy in different ways may kill more tumor cells. It is not yet known which regimen of~     radiation therapy is more effective in treating patients who have metastases to the lymph~     nodes in the neck.~      PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in~     treating patients who have metastases to the lymph nodes in the neck from an unknown primary~     tumor.~   "
268688|NCT00047112|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving combination chemotherapy with radiation therapy before~     surgery may shrink the tumor so it can be removed during surgery. It is not yet known if~     surgery is more effective with or without radiation therapy and chemotherapy in treating~     esophageal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without~     radiation therapy and chemotherapy in treating patients who have esophageal cancer.~   "
268689|NCT00047099|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving them after surgery may kill~     any remaining tumor cells following surgery. It is not yet known which combination~     chemotherapy regimen is more effective in treating breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination~     chemotherapy regimens in treating women who have primary breast cancer.~   "
268690|NCT00047073|"~     RATIONALE: Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from~     dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink~     the tumor so that it can be removed during surgery.~      PURPOSE: Phase I/II trial to study the effectiveness of sirolimus in treating patients who~     have glioblastoma multiforme that did not respond to previous radiation therapy.~   "
268691|NCT00047060|"~     This study will investigate the safety and effectiveness of a modified donor stem cell~     transplantation procedure for treating advanced mycosis fungoides (MF), a lymphoma primarily~     affecting the skin, and Sezary syndrome (SS), a leukemic form of the disease. Donated stem~     cells (cells produced by the bone marrow that mature into the different blood components~     white cells, red cells and platelets) can cure patients with certain leukemias and lymphomas~     and multiple myeloma. These cells generate a completely new, functioning bone marrow. In~     addition, immune cells from the donor grow and generate a new immune system to help fight~     infections. The new immune cells also attack any residual tumor cells left in the body after~     intensive chemotherapy. However, stem cell transplantation carries a significant risk of~     death, because it requires completely suppressing the immune system with high-dose~     chemotherapy and radiation. In addition, lymphocytes from the donor may cause what is called~     graft vs. host disease (GvHD), in which these cells see the patient s cells as foreign and~     mount an immune response to destroy them. To try to reduce these risks, patients in this~     study will be given low-dose chemotherapy and no radiation, a regimen that is easier for the~     body to tolerate and involves a shorter period of complete immune suppression. In addition, a~     monoclonal antibody called Campath-1H will be given to target lymphocytes, including those~     that have become cancerous.~      Patients with advanced MF or SS who are between 18 and 70 years of age and have a matched~     family donor 18 years of age or older may be eligible for this study. Candidates will have a~     medical history, physical examination and blood tests, lung and heart function tests, X-rays~     of the chest, eye examination, and bone marrow sampling (withdrawal through a needle of about~     a tablespoon of marrow from the hip bone), and small skin biopsy (surgical removal of a piece~     of tissue for microscopic examination) or needle biopsy of the tumor.~      Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF~     will be injected under the skin for several days to push stem cells out of the bone marrow~     into the bloodstream. Then, the stem cells will be collected by apheresis. In this procedure~     the blood is drawn through a needle placed in one arm and pumped into a machine where the~     required cells are separated out and removed. The rest of the blood is returned through a~     needle in the other arm.~      Before the transplant, a central venous line (large plastic tube) is placed into a major~     vein. This tube can stay in the body and be used the entire treatment period to deliver the~     donated stem cells, give medications, transfuse blood, if needed, and withdraw blood samples.~     Several days before the transplant procedure, patients will start a conditioning regimen of~     low-dose chemotherapy with Campath 1H, fludarabine, and, if necessary, cyclophosphamide. When~     the conditioning therapy is completed, the stem cells will be infused over a period of up to~     4 hours. To help prevent rejection of donor cells and GvHD, cyclosporine and mycophenolate~     mofetil will be given by mouth or by vein for about 3 months starting 4 days before the~     transplantation.~      The anticipated hospital stay is 3 to 4 days, when the first 3 doses of Campath will be~     monitored for drug side effects. The rest of the procedures, including the transplant, can be~     done on an outpatient basis. Follow-up visits for the first 3 months after the transplant~     will be scheduled once or twice a week for a physical examination, blood tests and symptoms~     check. Then, visits will be scheduled at 6, 12, 18, 24, 30, 36, and 48 months~     post-transplant. Visits for the first 3 years will include blood tests, skin biopsies, and~     bone marrow biopsies.~   "
268692|NCT00047047|"~     This phase I trial studies the side effects, best way to give, and best doses of tanespimycin~     with or without gemcitabine hydrochloride and cisplatin in treating patients with advanced~     solid tumors. Drugs used in chemotherapy, such as tanespimycin, gemcitabine hydrochloride,~     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Using more than one drug (combination~     chemotherapy) may kill more tumor cells.~   "
268693|NCT00047034|"~     Phase I trial to study the effectiveness of E7389 in treating patients who have advanced~     solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die~   "
268694|NCT00047021|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone~     in treating patients who have recurrent or refractory leukemia or lymphoma.~   "
268695|NCT00047008|"~     RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving~     radiation therapy in different ways and combining it with chemotherapy before surgery may~     kill more tumor cells. It is not yet known which radiation therapy regimen combined with~     chemotherapy with or without surgery is more effective for head and neck cancer.~      PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens~     combined with cisplatin with or without surgery in treating patients who have stage III or~     stage IV head and neck cancer.~   "
268696|NCT00046995|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which schedule of chemotherapy is most~     effective in treating colon cancer.~      PURPOSE: Randomized phase III trial to compare different schedules of chemotherapy using~     carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage~     III colon cancer.~   "
268697|NCT00046969|"~     RATIONALE: Epoetin beta may stimulate red blood cell production to prevent or control anemia~     in patients treated with chemotherapy and radiation therapy.~      PURPOSE: Randomized phase IV trial to determine the effectiveness of epoetin beta in treating~     anemia in patients who are receiving cisplatin and radiation therapy for stage IIB, stage~     III, or stage IVA cervical cancer.~   "
268698|NCT00046943|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients~     who have prostate cancer that has not responded to hormone therapy.~   "
268699|NCT00046930|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance~     (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells~     more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more~     effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or~     anemia.~      PURPOSE: This randomized phase III trial is studying how well giving zosuquidar~     trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and~     cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or~     anemia that has not responded to previous treatment.~   "
268700|NCT00046917|"~     Phase I trial to study the effectiveness of combining alvocidib, irinotecan hydrochloride,~     and cisplatin in treating patients who have advanced solid tumors. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die. Combining~     more than one drug may kill more tumor cells.~   "
268701|NCT00046904|"~     RATIONALE: Etanercept is a substance that is being studied as a treatment for cachexia~     (weight loss) and anorexia (lack of appetite) in patients who have cancer. It is not yet~     known whether etanercept is effective in improving cancer-related cachexia and anorexia.~      PURPOSE: Randomized phase III trial to determine the effectiveness of etanercept in treating~     cancer-related cachexia and anorexia in patients who have advanced cancer.~   "
268702|NCT00046891|"~     RATIONALE: Chemotherapy may cause memory loss, attention loss, and other problems that make~     it difficult for patients to think clearly. EGb761 may help maintain mental clarity in~     patients undergoing chemotherapy.~      PURPOSE: Randomized clinical trial to study the effectiveness of EGb761 in preventing loss of~     mental clarity in women who are receiving chemotherapy for newly diagnosed breast cancer.~   "
268703|NCT00046865|"~     RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing~     chemotherapy. It is not yet known whether acupressure plus standard care for nausea is more~     effective than standard care alone for nausea in women who are receiving chemotherapy for~     breast cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of acupressure in treating~     nausea in women who are receiving combination chemotherapy for breast cancer.~   "
268704|NCT00046852|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell~     transplantation and immunotherapy may allow the doctor to give higher doses of chemotherapy~     drugs and kill more cancer cells. Biological therapies use different ways to stimulate the~     immune system and stop cancer cells from growing.~      PURPOSE: Randomized phase I/II trial to study the effectiveness of combining chemotherapy~     with peripheral stem cell transplantation followed by immunotherapy in treating patients who~     have multiple myeloma.~   "
268705|NCT00046839|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may~     stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor~     cells more sensitive to radiation therapy.~      PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation~     therapy in treating patients who have locally advanced non-small cell lung cancer.~   "
268706|NCT00046826|"~     RATIONALE: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the~     tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and estramustine~     with thalidomide in treating patients who have prostate cancer previously treated with~     hormone therapy.~   "
268707|NCT00045747|"~     RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in~     treating patients who have metastatic pancreatic cancer that has not responded to treatment~     with gemcitabine.~   "
268708|NCT00045734|"~     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have~     recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the~     enzymes necessary for tumor cell growth~   "
268709|NCT00045721|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemotherapy placed into the surrounding tissue after surgery to~     remove the tumor may kill any remaining tumor cells. O(6)-benzylguanine may increase the~     effectiveness of carmustine by making tumor cells more sensitive to the drug.~      PURPOSE: Phase I trial to study the safety of combining O(6)-benzylguanine with carmustine~     implants in treating children who have recurrent malignant glioma.~   "
268710|NCT00045708|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. This phase I/II trial is studying the side effects and best dose of~     ixabepilone and how well it works in treating patients with recurrent glioma.~   "
268711|NCT00045695|"~     RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for~     tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who~     have untreated or relapsed Waldenstrom's macroglobulinemia.~   "
268712|NCT00045682|"~     Phase II trial to study the effectiveness of CT-2103 in treating patients who have recurrent~     or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die.~   "
268713|NCT00045669|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes~     necessary for tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients~     who have unresectable and/or metastatic salivary gland cancer.~   "
268714|NCT00045630|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells and decrease~     the need for surgery.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     observation or surgery to remove the bladder (cystectomy) in treating patients who have stage~     II or stage III cancer of the urothelium.~   "
268715|NCT00045617|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells.~     Vaccines may make the body build an immune response to kill tumor cells. Combining~     chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation~     therapy with vaccine therapy in treating patients who have limited-stage small cell lung~     cancer.~   "
268716|NCT00045604|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes~     necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Combining imatinib mesylate with~     chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining imatinib mesylate with~     irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancer~   "
268717|NCT00045591|"~     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for~     their growth and by stopping blood flow to the tumor. It is not yet known which regimen of~     celecoxib is more effective in treating breast cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib~     in treating women who have metastatic or recurrent breast cancer~   "
268718|NCT00045565|"~     This phase I trial is studying the side effects and best dose of arsenic trioxide and~     radiation therapy in treating patients with newly diagnosed malignant glioma. Drugs such as~     arsenic trioxide may stop the growth of malignant glioma by stopping blood flow to the tumor.~     Radiation therapy uses high-energy x-rays to damage tumor cells. Combining arsenic trioxide~     with radiation therapy may kill more tumor cells.~   "
268719|NCT00045539|"~     RATIONALE: Drugs used in chemotherapy, such as methotrexate and thiotepa, work in different~     ways to stop cancer cells from dividing so they stop growing or die. Combining more than one~     drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining methotrexate with thiotepa in~     treating patients who have newly-diagnosed primary CNS lymphoma.~   "
268720|NCT00045526|"~     This phase II trial is studying erlotinib hydrochloride to see how well it works in treating~     patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop~     the growth of cancer by blocking the enzymes necessary for tumor cell growth.~   "
268721|NCT00045513|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining UCN-01 with fludarabine in~     treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic~     lymphoma.~   "
268722|NCT00045500|"~     RATIONALE: UCN-01 may stop the growth of cancer cells by blocking the enzymes necessary for~     cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from~     dividing so they stop growing or die. Combining UCN-01 with prednisone may kill more cancer~     cells.~      PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with prednisone in~     treating patients who have refractory solid tumors or lymphoma.~   "
268723|NCT00045487|"~     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have~     advanced kidney cancer.~   "
268724|NCT00045474|"~     RATIONALE: Brachytherapy uses radioactive material to kill cancer cells remaining after~     surgery.~      PURPOSE: Phase I trial to study the effectiveness of brachytherapy in treating patients who~     have recurrent malignant glioma.~   "
268725|NCT00045461|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several~     degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor~     cells. It is not yet known if chemotherapy is more effective with or without whole-body~     hyperthermia therapy in treating gynecologic cancer.~      PURPOSE: Randomized phase II/III trial to compare the effectiveness of chemotherapy with or~     without whole-body hyperthermia in treating patients who have recurrent ovarian epithelial,~     fallopian tube, or peritoneal cancer.~   "
268726|NCT00045448|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with docetaxel in~     treating patients who have advanced solid tumors.~   "
268727|NCT00045435|"~     This phase II trial studies how well reduced intensity donor peripheral blood stem cell~     (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia~     (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and~     total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer~     cells. It may also stop the patient's immune system from rejecting the donor's stem cells.~     The donated stem cells may replace the patient's immune cells and help destroy any remaining~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving cyclosporine and~     mycophenolate mofetil after the transplant may stop this from happening~   "
268728|NCT00045422|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Imatinib mesylate~     may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.~     Combining interferon alfa with imatinib mesylate may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with imatinib~     mesylate in treating patients who have chronic myelogenous leukemia.~   "
268729|NCT00045396|"~     Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their~     growth. Phase II trial to study the effectiveness of tipifarnib in treating patients who have~     acute myeloid leukemia or myelodysplastic syndrome in first complete remission~   "
268730|NCT00045370|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies such as interferon alfa use different ways to~     stimulate the immune system and stop cancer cells from growing. Combining biological therapy~     with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological~     therapy in treating patients who have locally advanced or metastatic kidney cancer.~   "
268731|NCT00045331|"~     RATIONALE: Proteins found in blood and urine samples may help predict outcome and allow~     doctors to plan more effective treatment.~      PURPOSE: Diagnostic trial to study blood and urine proteins in predicting treatment outcome~     in patients who are undergoing radiation therapy for prostate cancer.~   "
268732|NCT00045318|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of exatecan mesylate in treating patients~     who have advanced solid tumors and kidney dysfunction.~   "
268733|NCT00045305|"~     RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside~     the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation~     therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune~     system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving pentostatin before transplant and cyclosporine or~     mycophenolate mofetil after transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well giving pentostatin together with~     photopheresis and total-body irradiation work before donor bone marrow transplant in treating~     patients with myelodysplastic syndromes.~   "
268734|NCT00045292|"~     RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in~     preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing~     cytomegalovirus in patients undergoing stem cell transplantation.~      PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in~     preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.~   "
268735|NCT00045279|"~     RATIONALE: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow~     to the tumor.~      PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating~     patients who have metastatic kidney cancer.~   "
268736|NCT00045266|"~     RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by~     stopping blood flow to the cancer.~      PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in treating patients who have~     relapsed or refractory solid tumors or non-Hodgkin's lymphoma.~   "
268737|NCT00045227|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or~     without docetaxel in treating patients who have metastatic prostate cancer.~   "
268738|NCT00045201|"~     Phase I trial to study the effectiveness of combining erlotinib hydrochloride with irinotecan~     hydrochloride in treating patients who have advanced solid tumors. Erlotinib hydrochloride~     may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining erlotinib hydrochloride and chemotherapy may kill more tumor cells.~   "
268739|NCT00045188|"~     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have~     metastatic breast cancer. Imatinib mesylate may stop the growth of cancer by blocking the~     enzymes necessary for tumor cell growth~   "
268740|NCT00045175|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the~     enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more~     tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in~     treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or~     primary peritoneal cavity cancer.~   "
268741|NCT00045162|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether cisplatin combined with irinotecan is more effective than cisplatin~     combined with etoposide in treating extensive-stage small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with~     either irinotecan or etoposide in treating patients who have extensive-stage small cell lung~     cancer.~   "
268742|NCT00045136|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Holmium Ho 166 DOTMP may deliver radiation directly to cancer~     cells and cause less damage to normal tissue. Combining chemotherapy and holmium Ho 166 DOTMP~     with peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy and holmium Ho 166 DOTMP and kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining holmium Ho 166 DOTMP with~     melphalan and peripheral stem cell transplantation in treating patients who have multiple~     myeloma.~   "
268743|NCT00045110|"~     Phase I/II trial to study the effectiveness of erlotinib in treating patients who have~     recurrent malignant glioma or recurrent or progressive meningioma. Erlotinib may stop the~     growth of tumor cells by blocking the enzymes necessary for tumor cell growth.~   "
268744|NCT00045097|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with~     locally advanced or metastatic breast cancer.~   "
268745|NCT00045045|"~     RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to~     detect the extent of cancer and allow doctors to plan more effective treatment for patients~     who have testicle cancer.~      PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using~     fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of~     the testicle.~   "
268746|NCT00045032|"~     The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus~     observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have~     completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if~     applicable. Efficacy and safety will be assessed for 10 years from randomization for each~     participant. All participants will continue to be followed for survival until 10 years after~     enrollment of the last participant.~   "
268747|NCT00045019|"~     RATIONALE: Questionnaires may help determine cancer patients' satisfaction with the quality~     of care they received in the hospital.~      PURPOSE: Clinical trial to determine the effectiveness of questionnaires in assessing cancer~     patients' satisfaction with the quality of care they received in the hospital.~   "
268748|NCT00045006|"~     RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking~     the enzymes necessary for cancer cell growth.~      PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in~     treating patients who have advanced cancer.~   "
268749|NCT00044993|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Inserting the p53 gene into the tumor may increase the~     effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.~     Combining chemotherapy with gene therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gene~     therapy in treating patients who have stage III or stage IV breast cancer.~   "
268750|NCT00044980|"~     RATIONALE: An individualized, computer-designed health program may promote changes in diet~     and physical activity and may improve quality of life in patients who have early-stage~     prostate cancer.~      PURPOSE: Randomized clinical trial to compare the effectiveness of an individualized,~     computer-designed diet and exercise-based counseling program with that of a standard~     counseling program in promoting health in patients who have early-stage prostate cancer.~   "
268751|NCT00044967|"~     RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan~     effective treatment for patients who develop colorectal cancer at an early age.~      PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the~     outcome of treatment in patients who develop stage I, stage II, or stage III colorectal~     cancer at an early age.~   "
268752|NCT00044954|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the~     doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with~     fludarabine and donor peripheral stem cell transplantation in treating patients who have~     hematologic cancer.~   "
268753|NCT00043147|"~     RATIONALE: Beclomethasone combined with prednisone may be an effective treatment for~     graft-versus-host disease caused by stem cell transplantation. It is not yet known if~     prednisone is more effective with or without beclomethasone in treating gastrointestinal~     graft-versus-host disease.~      PURPOSE: Randomized phase III trial to determine the effectiveness of prednisone with or~     without beclomethasone in treating patients who have graft-versus-host disease afftecting the~     gastrointestinal system.~   "
268754|NCT00043134|"~     RATIONALE: Decitabine may help myelodysplasia cells develop into normal stem cells. It is not~     yet known if decitabine is more effective than standard supportive care in treating~     myelodysplastic syndrome.~      PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose decitabine with~     that of standard supportive care in treating older patients who have myelodysplastic~     syndrome.~   "
268755|NCT00043121|"~     This phase I trial studies the side effects and best dose of capecitabine when given together~     with oxaliplatin, leucovorin calcium, and fluorouracil in treating patients with advanced~     cancer that is metastatic or cannot be removed by surgery. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining more~     than one drug may kill more tumor cells.~   "
268756|NCT00043095|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with gemcitabine in~     treating patients who have advanced solid tumors.~   "
268757|NCT00043082|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if carboplatin is more effective with or without liposomal doxorubicin in treating~     recurrent ovarian epithelial or primary peritoneal cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of carboplatin with or~     without liposomal doxorubicin in treating patients who have recurrent ovarian epithelial or~     primary peritoneal cancer.~   "
268758|NCT00043069|"~     RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate~     cancer may decrease the risk of fractures and may help patients live more comfortably. It is~     not yet known whether calcium is more effective with or without estrogen and/or risedronate~     in preventing osteoporosis.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with~     or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate~     cancer who are receiving androgen ablation therapy.~   "
268759|NCT00043043|"~     RATIONALE: Celecoxib may be effective in preventing colorectal cancer in patients who have a~     history of rectal polyps or colorectal neoplasia.~      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing~     colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.~   "
268760|NCT00043030|"~     RATIONALE: Understanding why patients participate in a phase I clinical trial may help~     doctors plan better treatment for cancer.~      PURPOSE: This clinical trial is studying to determine the reasons for participation,~     perceptions, and expectations of patients receiving treatment for cancer in phase I clinical~     trials.~   "
268761|NCT00043017|"~     RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may help determine~     the effectiveness of chemotherapy in killing breast cancer and allow doctors to plan more~     effective treatment.~      PURPOSE: Diagnostic trial to study the effectiveness of MRI in monitoring tumor response in~     women who are receiving chemotherapy for stage III breast cancer.~   "
268762|NCT00043004|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread by blocking blood~     flow. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not~     yet known if chemotherapy is more effective with or without radiofrequency ablation in~     treating liver metastases.~      PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab,~     and radiofrequency ablation to see how well they work compared to combination chemotherapy~     and bevacizumab alone in treating unresectable liver metastases in patients with colorectal~     cancer.~   "
268763|NCT00042991|"~     Biological therapies such as gefitinib may interfere with the growth of the tumor cells and~     may make the tumor cells more sensitive to radiation therapy. This phase I/II trial is~     studying how well giving gefitinib together with radiation therapy works in treating children~     with newly diagnosed glioma.~   "
268764|NCT00042978|"~     This phase II trial studies how well carboplatin and etoposide with or without oblimersen~     sodium works in treating patients with extensive stage small cell lung cancer. Drugs used in~     chemotherapy, such as carboplatin and etoposide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Biological~     therapies, such as oblimersen sodium, may stimulate the immune system in different ways and~     stop cancer cells from growing. Giving carboplatin and etoposide together with oblimersen~     sodium may kill not tumor cells~   "
268765|NCT00042965|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining capecitabine with gemcitabine~     in treating patients who have metastatic kidney cancer.~   "
268766|NCT00042952|"~     Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth. Phase II trial to study the effectiveness of imatinib mesylate in treating~     patients who have progressive, refractory, or recurrent stage II or stage III testicular~     cancer or stage II or stage III ovarian cancer following cisplatin-based chemotherapy~   "
268767|NCT00042939|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells.~     Combining chemotherapy with cetuximab may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together~     with cetuximab to see how well it works compared to irinotecan and docetaxel alone in~     treating patients with metastatic pancreatic cancer .~   "
268768|NCT00042926|"~     RATIONALE: Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan~     effective cancer treatment.~      PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph~     node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of~     the mouth.~   "
268769|NCT00042913|"~     RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of epratuzumab in treating~     patients who have non-Hodgkin's lymphoma.~   "
268770|NCT00042887|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more~     cancer cells. It is not yet known if surgery followed by chemotherapy is more effective than~     chemotherapy alone in treating bladder cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy alone with~     that of transurethral resection followed by chemotherapy in treating patients who have~     bladder cancer.~   "
268771|NCT00042874|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug may kill more tumor cells. This phase I trial is~     studying the side effects and best dose of combination chemotherapy in treating patients with~     locally advanced or metastatic solid tumors.~   "
268772|NCT00042861|"~     RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for~     tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of combining UCN-01, fluorouracil, and~     leucovorin in treating patients who have metastatic or unresectable solid tumors.~   "
268773|NCT00042848|"~     RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are~     undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related~     fatigue is not yet known.~      PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in~     treating fatigue in patients who are receiving chemotherapy for cancer.~   "
268774|NCT00042835|"~     Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or~     die. Combining erlotinib and radiation therapy with combination chemotherapy may kill more~     tumor cells. Phase I trial to study the effectiveness of combining erlotinib and radiation~     therapy with combination chemotherapy in treating patients who have inoperable stage III~     non-small cell lung cancer~   "
268775|NCT00042822|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have~     myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.~   "
268776|NCT00042809|"~     Phase I trial to study the effectiveness of combining erlotinib and trastuzumab with~     paclitaxel in treating patients who have advanced solid tumors. Biological therapies such as~     erlotinib may interfere with the growth of the tumor cells and slow the growth of the tumor.~     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining erlotinib and trastuzumab with paclitaxel may kill more tumor cells~   "
268777|NCT00042796|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. This phase I trial is studying the side effects and best dose of decitabine~     in treating children with relapsed or refractory acute myeloid leukemia or acute~     lymphoblastic leukemia~   "
268778|NCT00042783|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine~     therapy may be effective in treating stage IV melanoma.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients~     who have stage IV melanoma.~   "
268779|NCT00042770|"~     RATIONALE: It is not yet known whether pleurodesis using a chest tube with infusions of talc~     is more effective in improving quality of life than pleurodesis using a small catheter in~     treating malignant pleural effusion.~      PURPOSE: Randomized phase III trial to compare the effectiveness of a chest tube and talc~     with that of a small catheter in treating malignant pleural effusion in patients who have~     cancer.~   "
268780|NCT00042731|"~     RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a~     substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or~     lycopene before surgery may be an effective treatment for prostate cancer.~      PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of~     lycopene before surgery in treating patients who have stage I or stage II prostate cancer.~   "
268781|NCT00041379|"~     RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the~     immune system and stop cancer cells from growing.~      PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients~     who have Waldenstrom's macroglobulinemia.~   "
268782|NCT00041340|"~     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have~     stage IV colorectal cancer. Imatinib mesylate may interfere with the growth of tumor cells by~     blocking certain enzymes necessary for cancer cell growth~   "
268783|NCT00041327|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Antiviral therapy may kill viruses such as HTLV-1 that can cause~     cancer. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy~     with antiviral drugs and interferon alfa may be effective in treating adult T-cell~     leukemia/lymphoma.~      PURPOSE: Phase II trial to determine the effectiveness of combination chemotherapy followed~     by antiviral therapy and interferon alfa in treating patients who have adult T-cell~     leukemia/lymphoma caused by HTLV-1.~   "
268784|NCT00041314|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind~     in treating patients who have advanced non-small cell lung cancer.~   "
268785|NCT00041301|"~     RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may~     help determine the intermediate and long-term effects of the treatment on these patients.~      PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality~     of life of patients who have prostate cancer.~   "
268786|NCT00041288|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Peripheral stem cell transplantation may be able to replace immune cells that were destroyed~     by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the~     body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may~     prevent this from happening.~      PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus~     total-body irradiation with that of combination chemotherapy followed by donor peripheral~     stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or~     chronic lymphocytic leukemia.~   "
268787|NCT00041262|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of combination chemotherapy is more effective in treating esophageal~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of~     combination chemotherapy in treating patients who are undergoing surgery for esophageal~     cancer.~   "
268788|NCT00041249|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who~     have locally advanced or metastatic soft tissue sarcoma that has not responded to one~     previous chemotherapy regimen.~   "
268789|NCT00041236|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients~     who have advanced soft tissue sarcoma.~   "
268790|NCT00041223|"~     RATIONALE: IH636 grape seed extract may lessen hardening of breast tissue caused by radiation~     therapy and may help patients live more comfortably.~      PURPOSE: Randomized phase II trial to study the effectiveness of IH636 grape seed extract in~     treating hardening of breast tissue in women who have undergone radiation therapy for early~     breast cancer.~   "
268818|NCT00040755|"~     BMS-275291 may stop the growth of prostate cancer by stopping blood flow to the tumor and by~     blocking the enzymes necessary for tumor cell growth. Randomized phase II trial to study the~     effectiveness of BMS-275291 in treating patients who have prostate cancer that has not~     responded to hormone therapy~   "
268791|NCT00041210|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which combination chemotherapy regimen is more effective in treating patients~     who have advanced Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination~     chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.~   "
268792|NCT00041197|"~     This randomized phase III trial is studying imatinib mesylate to see how well it works~     compared to placebo in treating patients with primary gastrointestinal stromal tumor that has~     been completely removed by surgery. Imatinib mesylate may interfere with the growth of tumor~     cells and may be an effective treatment for patients with primary gastrointestinal stromal~     tumor that has been completely removed by surgery.~   "
268793|NCT00041171|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. St. John's wort may interfere with the effectiveness of~     chemotherapy. It is not yet known if chemotherapy is more effective with or without St.~     John's Wort in treating solid tumors.~      PURPOSE: Randomized phase III trial to compare the effectiveness of docetaxel with or without~     St. John's wort in treating patients who have solid tumors that cannot be removed by surgery.~   "
268794|NCT00041132|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells~     and either kill them or deliver cancer-killing substances to them without harming normal~     cells. Combining rituximab with chemotherapy may kill more cancer cells.~      PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with~     rituximab in treating patients who have newly diagnosed mantle cell lymphoma.~   "
268795|NCT00041119|"~     This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride~     compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3~     positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to~     lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy,~     such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. It is not yet known whether the standard~     adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than~     paclitaxel in treating women with breast cancer~   "
268796|NCT00041106|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Biological therapies such as gefitinib may interfere with the growth of the~     tumor cells and slow the growth of the tumor. Combining chemotherapy with gefitinib may kill~     more tumor cells. Phase II trial to study the effectiveness of combining chemotherapy with~     gefitinib in treating patients who have metastatic transitional cell cancer of the urothelium~   "
268797|NCT00041093|"~     Phase II trial to study the effectiveness of docetaxel in treating patients who have~     persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die.~   "
268798|NCT00041080|"~     Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide~     in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or~     primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells.~     Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen.~     Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet~     known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial~     cancer, fallopian tube cancer, or primary peritoneal cancer.~   "
268799|NCT00041067|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate~     tumor cells and either kill them or deliver tumor-killing substances to them without harming~     normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune~     system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel,~     vinorelbine, and filgrastim in treating women who have stage IV breast cancer.~   "
268800|NCT00041054|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Exisulind may make tumor cells more sensitive to chemotherapy.~     Combining chemotherapy with exisulind may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind~     in treating patients who have extensive-stage small cell lung cancer.~   "
268801|NCT00041041|"~     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have~     persistent or recurrent ovarian epithelial or primary peritoneal cancer. Imatinib mesylate~     may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth~   "
268802|NCT00041028|"~     RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of~     anticancer therapy. EF5 is a drug used in the measurement of oxygen in tumor tissue.~      PURPOSE: Phase II trial to study the effectiveness of EF5 in assessing tumor response to~     anticancer therapy in patients who have stage I, stage II, or stage III non-small cell lung~     cancer.~   "
268803|NCT00041015|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective in treating~     extensive-stage small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating~     patients who have extensive-stage small cell lung cancer.~   "
268804|NCT00040989|"~     RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary~     for tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who~     have recurrent, unresectable, or metastatic kidney cancer.~   "
268819|NCT00040742|"~     RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs~     are more effective with or without ginger in treating nausea caused by chemotherapy.~      PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with~     ginger to see how well they work compared to antiemetic drugs alone in treating nausea in~     patients who are receiving chemotherapy for cancer.~   "
268805|NCT00040950|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Biological~     therapies such as CpG 7909 use different ways to stimulate the immune system and stop cancer~     cells from growing. Combining CpG 7909 with rituximab may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of CpG 7909 plus rituximab in treating~     patients who have relapsed or refractory non-Hodgkin's lymphoma.~   "
268806|NCT00040937|"~     RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the~     cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Giving thalidomide before and after peripheral stem cell transplant may be effective in~     treating newly diagnosed multiple myeloma.~      PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and~     peripheral stem cell transplant work in treating patients with newly diagnosed multiple~     myeloma.~   "
268807|NCT00040911|"~     RATIONALE: Electroacupuncture may help to reduce or prevent delayed nausea and vomiting in~     patients treated with chemotherapy.~      PURPOSE: This randomized clinical trial is studying the effectiveness of electroacupuncture~     in treating delayed nausea and vomiting in patients who are receiving chemotherapy for newly~     diagnosed childhood sarcoma, neuroblastoma, nasopharyngeal cancer, germ cell tumors, or~     Hodgkin lymphoma.~   "
268808|NCT00040898|"~     RATIONALE: The Chinese herbal medicine Sho-saiko-to contains ingredients that may slow the~     growth of tumor cells and stimulate a person's immune system to help kill tumor cells. This~     may be an effective treatment following hepatic artery embolization.~      PURPOSE: Phase II trial to study the effectiveness of Sho-saiko-to following hepatic artery~     embolization in treating patients who have liver cancer.~   "
268809|NCT00040885|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Infliximab may improve cancer-related~     weight loss, lack of appetite, and fatigue. It is not yet known whether docetaxel is more~     effective with or without infliximab in preventing weight loss and fatigue in patients with~     advanced cancer. (Infliximab treatment discontinued effective 10/05/05)~      PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel with or~     without infliximab in preventing weight loss, loss of appetite, and fatigue in patients who~     have unresectable non-small cell lung cancer. (Infliximab treatment discontinued effective~     10/05/05)~   "
268810|NCT00040872|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~     Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing~     substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Biological therapies use different ways to stimulate the immune system~     and stop cancer cell from growing. Combining different types of therapies may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, monoclonal~     antibody therapy, surgery, peripheral stem cell transplantation, radiation therapy, and~     biological therapy in treating patients who have advanced neuroblastoma.~   "
268811|NCT00040859|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine~     in treating patients who have advanced esophageal cancer or stomach cancer.~   "
268812|NCT00040846|"~     This phase II trial studies the side effects and the best dose of alemtuzumab when given~     together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it~     works before donor stem cell transplant in treating patients with hematological malignancies.~     Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant~     helps stop the growth of cancer cells. It may also stop the patient's immune system from~     rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find~     cancer cells and either kill them or deliver cancer-killing substances to them without~     harming normal cells. When the healthy stem cells from a donor are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets. Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF)~     after transplant may stop this from happening.~   "
268813|NCT00040833|"~     RATIONALE: Acupuncture and acupressure may help relieve moderate or severe pain associated~     with stage III or stage IV pancreatic cancer.~      PURPOSE: Phase II trial to study the effectiveness of acupuncture and accupressure in~     treating patients who have moderate or severe pain associated with stage III or stage IV~     pancreatic cancer.~   "
268814|NCT00040807|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan and docetaxel in treating~     patients who have metastatic or locally recurrent head and neck cancer.~   "
268815|NCT00040794|"~     This phase II clinical trial studies how well combining different regimens of chemotherapy~     and gefitinib with radiation therapy work in treating patients with stage III non-small cell~     lung cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Biological therapies~     such as gefitinib may interfere with the growth of tumor cells and slow the growth of~     non-small cell lung cancer. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Giving different regimens of combination therapy together with gefitinib and radiation~     therapy may be an effective treatment for non-small cell lung cancer.~   "
268816|NCT00040781|"~     Phase I trial to study the effectiveness of gefitinib in treating children who have~     refractory solid tumors. Gefitinib may stop the growth of cancer cells by blocking the~     enzymes necessary for tumor cell growth~   "
268817|NCT00040768|"~     Phase II trial to study the effectiveness of bortezomib in treating patients who have stage~     IIIB, stage IV, or recurrent non-small cell lung cancer. Bortezomib may interfere with the~     growth of tumor cells by blocking certain enzymes necessary for tumor cell growth~   "
268820|NCT00040690|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have Burkitt's lymphoma or Burkitt's leukemia.~   "
268821|NCT00039611|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced colorectal cancer.~   "
268822|NCT00039585|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes~     necessary for cancer cell growth.~      PURPOSE: Phase II trial to determine the effectiveness of imatinib mesylate in treating~     patients who have refractory or relapsed ovarian epithelial, fallopian tube, or primary~     peritoneal cancer, or ovarian low malignant potential tumor.~   "
268823|NCT00039572|"~     RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells~     without harming normal tissue.~      PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in~     treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.~   "
268824|NCT00039559|"~     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective~     treatment for ovarian cancer.~      PURPOSE: Screening trial to determine the significance of cancer antigen 125 (CA125) levels~     in detecting ovarian cancer in participants who have a high genetic risk of developing~     ovarian cancer.~   "
268825|NCT00039546|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which chemotherapy regimen is more effective in treating women after surgery for~     breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel, epirubicin,~     and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery~     for breast cancer.~   "
268826|NCT00039520|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining sulindac with docetaxel in~     treating women who have metastatic or recurrent breast cancer.~   "
268827|NCT00039507|"~     RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells.~     Combining radiofrequency ablation with surgery may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining radiofrequency ablation with~     surgery in treating patients who have stage I or stage II non-small cell lung cancer.~   "
268828|NCT00039494|"~     This pilot phase II trial is studying the side effects and best dose of erlotinib when given~     with temozolomide and radiation therapy and to see how well they work in treating patients~     with glioblastoma multiforme or other brain tumors. Radiation therapy uses high-energy x-rays~     to damage tumor cells. Erlotinib may interfere with the growth of tumor cells, slow the~     growth of the tumor, and make the tumor cells more sensitive to radiation therapy. Drugs used~     in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from~     dividing so they stop growing or die. Combining erlotinib and temozolomide with radiation~     therapy may kill more tumor cells.~   "
268829|NCT00039481|"~     Phase I trial to study the effectiveness of oblimersen plus combination chemotherapy and~     dexrazoxane in treating children and adolescents who have relapsed or refractory solid~     tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and~     cyclophosphamide by making the tumor cells more sensitive to the drug. Chemoprotective drugs~     such as dexrazoxane may protect normal cells from the side effects of chemotherapy~   "
268830|NCT00039468|"~     RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow~     to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells~     remaining after radiation therapy.~      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan~     in treating patients who have glioblastoma multiforme that has been treated with radiation~     therapy.~   "
268831|NCT00039455|"~     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining trastuzumab with flavopiridol may kill more tumor cells. Phase I trial to~     study the effectiveness of combining trastuzumab with flavopiridol in treating patients who~     have metastatic breast cancer~   "
268832|NCT00039442|"~     Phase II trial to study the effectiveness of capecitabine in treating patients who have~     persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die.~   "
268833|NCT00039429|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with~     locally recurrent or metastatic kidney cancer.~   "
268834|NCT00039416|"~     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have~     myelofibrosis. Imatinib mesylate may stop the growth of myelofibrosis by blocking certain~     enzymes necessary for cell growth.~   "
268835|NCT00039403|"~     Phase I trial to study the effectiveness of combining UCN-01 with gemcitabine in treating~     patients who have unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may~     help gemcitabine kill more cancer cells by making tumor cells more sensitive to the drug~   "
268836|NCT00039390|"~     This phase I trial is studying the side effects and best dose of gefitinib and capecitabine~     in treating patients with advanced solid tumors. Biological therapies such as gefitinib may~     interfere with the growth of tumor cells and slow the growth of solid tumors. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining gefitinib and capecitabine may kill more tumor cells~   "
268837|NCT00039377|"~     This phase II trial studies how well giving imatinib mesylate together with chemotherapy and~     peripheral stem cell transplantation works in treating patients with newly diagnosed acute~     lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells~     from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer~     cells by blocking the enzymes necessary for cancer cell growth. Giving imatinib mesylate~     together with chemotherapy and peripheral stem cell transplantation may be an effective~     treatment for acute lymphoblastic leukemia.~   "
268838|NCT00039364|"~     RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth~     of the tumor.~      PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients~     who have gliomas.~   "
268839|NCT00039351|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     older patients who have non-Hodgkin's lymphoma.~   "
268840|NCT00039338|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so~     that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is~     not yet known whether chemotherapy is more effective followed by surgery or combined with~     radiation therapy in treating cervical cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by~     radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients~     who have stage IB or stage II cervical cancer.~   "
268841|NCT00039325|"~     RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood~     cells may make the body build an immune response to kill tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy~     and to see how well it works in treating patients with stage IV or recurrent malignant~     melanoma.~   "
268842|NCT00039312|"~     RATIONALE: Screening tests may help doctors detect abnormal cells in the cervix early and~     plan effective treatment.~      PURPOSE: Screening trial to compare different types of screening tests used to detect~     cervical neoplasia.~   "
268843|NCT00039299|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing~     them may cause a stronger immune response and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who~     have prostate cancer that has not responded to hormone therapy.~   "
268844|NCT00039286|"~     RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the~     ability to detect the extent of breast cancer.~      PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast~     cancer in women who have primary or recurrent breast cancer.~   "
268845|NCT00039273|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have relapsed or refractory metastatic colorectal cancer.~   "
268846|NCT00039234|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.~     Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells~     more sensitive to the drug. It is not yet known if interleukin-2 is more effective with or~     without histamine dihydrochloride in treating stage IV melanoma that is metastatic to the~     liver.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with or~     without histamine dihydrochloride in treating patients who have stage IV melanoma that is~     metastatic to the liver.~   "
268847|NCT00039208|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs at the time of day that allows for the best drug~     response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor~     cells.~      PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined~     with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal~     cancer.~   "
268848|NCT00039195|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells~     and either kill them or deliver cancer-killing substances to them without harming normal~     cells. Combining chemotherapy with monoclonal antibody therapy, total-body irradiation, and~     peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy~     drugs and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed~     by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral~     stem cell transplant works in treating patients with lymphoma.~   "
268849|NCT00039182|"~     Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This~     phase II trial is studying how well erlotinib works in treating patients with malignant~     mesothelioma of the lung~   "
268850|NCT00039156|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who~     have refractory non-Hodgkin's lymphoma.~   "
268851|NCT00039130|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells~     found in bone marrow or peripheral blood and may help a person's immune system recover from~     the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may~     kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy~     and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.~   "
269019|NCT00028652|"~     RATIONALE: Inserting the gene for interleukin-12 into a person's skin tumor cells may make~     the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating~     patients who have skin metastases.~   "
268852|NCT00039117|"~     Phase I trial to study the effectiveness of combining oblimersen with cytarabine and~     daunorubicin in treating older patients who have previously untreated acute myeloid leukemia.~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Oblimersen may help cytarabine and daunorubicin kill more cancer cells by~     making them more sensitive to chemotherapy.~   "
268853|NCT00039104|"~     Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in~     treating patients who have prostate cancer that has not responded to previous hormone~     therapy. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone.~     BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer~     cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells.~   "
268854|NCT00039091|"~     This phase I trial is studying the side effects of monoclonal antibody therapy in treating~     patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic~     syndrome, or non-small cell lung cancer. Monoclonal antibodies can locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells~   "
268855|NCT00039078|"~     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near~     a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be~     effective treatment for liver cancer that cannot be removed by surgery.~      PURPOSE: This phase II trial is studying the side effects of hepatic arterial infusion using~     yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with~     liver cancer that cannot be removed by surgery.~   "
268856|NCT00039052|"~     RATIONALE: Interleukin-4 PE38KDEL cytotoxin may be able to deliver cancer-killing substances~     directly to solid tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of intravenous interleukin-4 PE38KDEL~     cytotoxin in treating patients who have recurrent or metastatic kidney cancer, non-small cell~     lung cancer, or breast cancer that has not responded to previous treatment.~   "
268857|NCT00039039|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not~     yet known if combination chemotherapy followed by radiation therapy is more effective with or~     without paclitaxel in treating unresectable stage III non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     followed by radiation therapy with or without paclitaxel in treating patients who have~     unresectable stage III non-small cell lung cancer.~   "
268858|NCT00037037|"~     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill~     tumor cells. Colony-stimulating factors such as sargramostim may increase the number of~     immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with~     sargramostim may kill more tumor cells.~      PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or~     without sargramostim in treating patients who have metastatic melanoma.~   "
268859|NCT00037024|"~     RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical~     function and quality of life in patients who have early-stage breast cancer or prostate~     cancer.~      PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and~     exercise-based counseling program with that of a standard home-based counseling program in~     promoting health in patients who have early-stage breast cancer or prostate cancer.~   "
268860|NCT00037011|"~     RATIONALE: Biological therapies such as beta-glucan use different ways to stimulate the~     immune system and stop cancer cells from growing. Monoclonal antibodies can locate tumor~     cells and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Combining beta-glucan and monoclonal antibody may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining beta-glucan and monoclonal~     antibody in treating patients who have metastatic neuroblastoma.~   "
268861|NCT00036998|"~     RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above~     body temperature.~      PURPOSE: Randomized phase II trial to compare the effectiveness of microwave thermotherapy~     before surgery to that of surgery alone in treating women who have stage I or stage II breast~     cancer.~   "
268862|NCT00036985|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to~     several degrees above body temperature. Combining chemotherapy with microwave thermotherapy~     before surgery may shrink the tumor so that it can be removed during surgery.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy~     with or without microwave thermotherapy before surgery in treating women who have locally~     advanced breast cancer.~   "
268863|NCT00036972|"~     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.~     Immunotoxin therapy may be effective in treating malignant glioma.~      PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy before and after~     surgery in treating patients who have recurrent malignant glioma.~   "
268864|NCT00036959|"~     RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects of ABT-751 in treating young~     patients with refractory solid tumors.~   "
268865|NCT00036946|"~     RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by~     stopping blood flow to the cancer.~      PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in patients who have relapsed~     or refractory solid tumors or non-Hodgkin's lymphoma.~   "
268866|NCT00036933|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Biological therapies such as QS21 use different ways to stimulate the immune system and stop~     cancer cells from growing. Combining vaccine therapy with QS21 may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with QS21 in~     treating patients who have prostate cancer.~   "
268867|NCT00036894|"~     RATIONALE: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have~     recurrent glioma.~   "
268868|NCT00036881|"~     RATIONALE: It is not yet known whether zinc sulfate is effective in preventing the loss of~     ability to taste food in cancer patients who are undergoing radiation therapy for head and~     neck cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of zinc sulfate in~     preventing loss of sense of taste in patients who are undergoing radiation therapy for head~     and neck cancer.~   "
268869|NCT00036868|"~     RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, methotrexate, and~     fluorouracil use different ways to stop tumor cells from dividing so they stop growing or~     die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them~     or deliver tumor-killing substances to them without harming normal cells. Combining~     chemotherapy with trastuzumab may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining combination chemotherapy with~     trastuzumab in treating women who have metastatic breast cancer.~   "
268870|NCT00036855|"~     Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy with or~     without peripheral stem cell transplantation in treating patients who have recurrent or~     refractory lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and deliver~     radioactive tumor-killing substances to them without harming normal cells. Peripheral stem~     cell transplantation may be able to replace immune cells that were destroyed by anticancer~     therapy~   "
268871|NCT00036842|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating men who~     have germ cell cancer that has not responded to previous treatment.~   "
268872|NCT00036829|"~     RATIONALE: A pain assessment and management system for people with cancer may help doctors~     accurately assess and plan more effective pain treatment for patients who have cancer.~      PURPOSE: Clinical trial to determine the effectiveness of a pain assessment and management~     system in improving pain management in patients who have nonhematologic cancer.~   "
268873|NCT00036816|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and~     decrease the recurrence of melanoma of the eye.~      PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in~     treating patients who are at high risk for recurrent melanoma of the eye.~   "
268874|NCT00036790|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Motexafin gadolinium may increase the effectiveness of doxorubicin~     by making tumor cells more sensitive to the drug.~      PURPOSE: Phase I trial to study the effectiveness of combining motexafin gadolinium with~     doxorubicin in treating patients who have recurrent or metastatic cancer.~   "
268875|NCT00036777|"~     Phase I trial to study the effectiveness of combining UCN-01 with carboplatin in treating~     patients who have advanced solid tumors. UCN-01 may stop the growth of tumor cells by~     blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     UCN-01 with carboplatin may kill more tumor cells.~   "
268876|NCT00036764|"~     Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage~     IV melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die~   "
268877|NCT00036751|"~     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have~     stage III or stage IV ovarian epithelial or primary peritoneal cancer that has not responded~     to previous treatment. Imatinib mesylate may stop the growth of tumor cells by blocking the~     enzymes necessary for cancer cell growth~   "
268878|NCT00036738|"~     This phase II trial is studying how well fludarabine phosphate and total-body irradiation~     followed by donor peripheral blood stem cell transplant work in treating patients with acute~     lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous~     treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy,~     such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral~     blood stem cell transplant helps stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune system and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte~     infusion) after the transplant may help increase this effect. Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.~   "
268879|NCT00036712|"~     RATIONALE: Light-emitting diode (LED) therapy may be able to prevent mucositis of the mouth.~      PURPOSE: Randomized phase II trial to determine the effectiveness of LED therapy in~     preventing mucositis of the mouth in children who are receiving chemotherapy with or without~     radiation therapy before donor bone marrow transplantation.~   "
268880|NCT00036686|"~     RATIONALE: Eating a diet rich in soy foods may slow the progression of some types of cancer.~     Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells~     and prevent further development of breast cancer.~      PURPOSE: Randomized pilot trial to study the effectiveness of isoflavones in preventing~     further development of breast cancer in women who are planning to undergo mastectomy or~     lumpectomy.~   "
268881|NCT00033748|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients~     who have colorectal cancer that has spread to the liver.~   "
268882|NCT00033709|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to~     the tumor. Combining temozolomide with thalidomide may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide~     in treating patients who have metastatic, locally advanced, or unresectable leiomyosarcoma.~   "
268883|NCT00033696|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy and radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation~     therapy in treating patients who have limited-stage small cell lung cancer.~   "
268884|NCT00033683|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving them after surgery may kill~     any tumor cells remaining after surgery. It is not yet known which combination chemotherapy~     regimen is more effective in treating resected stage I or stage II breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination~     chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.~   "
268885|NCT00033657|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy with chemotherapy before and after surgery may kill more~     tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation~     therapy with two different chemotherapy regimens before and after surgery in treating~     patients who have esophageal cancer.~   "
268886|NCT00033644|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as sargramostim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the~     uterus.~   "
268887|NCT00033631|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet~     known which dose of radiation therapy is more effective in treating stage II prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of~     specialized radiation therapy in treating patients who have stage II prostate cancer.~   "
268888|NCT00033618|"~     Randomized phase II trial to study the effectiveness of ixabepilone in treating patients who~     have metastatic or recurrent head and neck cancer. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die~   "
268889|NCT00033605|"~     RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who~     are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is~     effective for diarrhea.~      PURPOSE: Randomized phase III trial to determine the effectiveness of octreotide in~     preventing diarrhea in patients who are undergoing radiation therapy to the pelvis.~   "
268890|NCT00033566|"~     RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the~     tumor.~      PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have~     solid tumors.~   "
268891|NCT00033553|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan~     treatment may result in more effective radiation therapy. It is not yet known which~     chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell~     lung cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of different combination~     chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have~     unresectable stage III non-small cell lung cancer.~   "
268892|NCT00033540|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different~     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one~     drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine~     in treating patients who have locally advanced or metastatic gallbladder cancer or~     cholangiocarcinoma.~   "
268893|NCT00033514|"~     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Biological~     therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth~     of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as~     first-line therapy in treating women who have metastatic breast cancer associated with~     HER2/neu overexpression.~   "
268894|NCT00033488|"~     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective~     treatment for ovarian cancer.~      PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women~     who have a high genetic risk for developing ovarian cancer.~   "
268895|NCT00033475|"~     RATIONALE: Some types of lymphoproliferative disease are associated with Epstein-Barr virus.~     Combining reduced immunosuppressive therapy with donor white blood cells that have been~     treated in the laboratory to kill cells infected with Epstein-Barr virus may be an effective~     treatment for lymphoproliferative disease.~      PURPOSE: Randomized phase III trial to compare the effectiveness of reducing~     immunosuppressive therapy with or without donor white blood cells in treating patients who~     have Epstein-Barr virus-associated lymphoproliferative disease after organ transplantation.~   "
268896|NCT00033449|"~     This phase I trial is studying the side effects and best dose of gefitinib when given~     together with radiation therapy with or without cisplatin in treating patients with stage III~     or stage IV head and neck cancer. Biological therapies such as gefitinib may interfere with~     the growth of tumor cells and slow the growth of cancer. Radiation therapy uses high-energy~     x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Combining gefitinib and radiation therapy~     with cisplatin may kill more tumor cells~   "
268897|NCT00033436|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     carbogen and niacinamide may make tumor cells more sensitive to radiation therapy. It is not~     yet known whether radiation therapy is more effective with or without carbogen and~     niacinamide in treating patients who have bladder cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without carbogen and niacinamide in treating patients who have locally advanced bladder~     cancer.~   "
268898|NCT00033423|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in~     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.~   "
268899|NCT00033410|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Tirapazamine may make the tumor cells more sensitive to radiation therapy. Combining~     chemotherapy, radiation therapy, and tirapazamine may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with tirapazamine~     and radiation therapy in treating patients who have stage II or stage III non-small cell lung~     cancer.~   "
268900|NCT00033397|"~     RATIONALE: Comparing results of diagnostic procedures performed before, during, and after~     chemotherapy may help doctors predict a patient's response to treatment and help plan the~     most effective treatment.~      PURPOSE: Diagnostic trial to study magnetic resonance imaging (MRI) and biomarkers in women~     who are receiving chemotherapy before surgery for locally advanced breast cancer.~   "
268901|NCT00033371|"~     This randomized phase II trial studies how well giving celecoxib with or without eflornithine~     works in preventing colorectal cancer in patients with familial adenomatous polyposis.~     Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib~     and eflornithine may keep cancer from forming in patients with familial adenomatous~     polyposis.~   "
268902|NCT00033358|"~     Randomized phase II trial to compare two different hormone therapy regimens in preventing~     endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer.~     Hormone therapy may prevent the development of endometrial cancer in women with a genetic~     risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy~     regimen is more effective in preventing endometrial cancer.~   "
268903|NCT00033345|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Indole-3-carbinol may be effective in preventing breast~     cancer.~      PURPOSE: Phase I trial to study the effectiveness of indole-3-carbinol in preventing breast~     cancer in nonsmoking women who are at high risk for breast cancer.~   "
268904|NCT00033332|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow~     to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not~     yet known whether dexamethasone is more effective with or without thalidomide in treating~     multiple myeloma.~      PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or~     without thalidomide in treating patients who have multiple myeloma.~   "
268905|NCT00033293|"~     This randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin~     to see how well they work compared to cyclophosphamide and prednisone alone in treating~     patients with abnormal eye and trunk muscle movements (known as opsoclonus myoclonus ataxia)~     associated with neuroblastoma. Drugs used in chemotherapy work in different ways to stop~     tumor cells from dividing so they stop growing or die. Steroid therapy decreases~     inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective~     in treating abnormal muscle movement associated with neuroblastoma.~     Chemotherapy(cyclophosphamide), prednisone and intravenous gamma globulin all suppress the~     immune system which may be helpful in treating opsoclonus-myoclonus-ataxia (OMA).~   "
268906|NCT00033280|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy and radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation~     therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed~     anaplastic oligoastrocytomas.~   "
268907|NCT00033267|"~     Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle~     cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer~     cells from dividing so they stop growing or die.~   "
268908|NCT00033254|"~     Randomized phase III trial to compare the effectiveness of radiation therapy with or without~     thalidomide in treating patients who have brain metastases. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of~     brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation~     therapy is more effective with or without thalidomide in treating brain metastases.~   "
268909|NCT00033241|"~     RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the~     tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining erlotinib with gemcitabine may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with gemcitabine in~     treating patients who have newly diagnosed locally advanced or metastatic pancreatic cancer~     or other solid tumors.~   "
268910|NCT00033228|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing~     the vaccine directly into a lymph node may cause a stronger immune response and kill more~     tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     who have stage IV melanoma.~   "
268911|NCT00032188|"~     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining bryostatin 1 with interleukin-2 may cause a stronger immune response and kill~     more tumor cells. Randomized phase II trial to study the effectiveness of combining~     interleukin-2 and bryostatin 1 in treating patients who have advanced kidney cancer~   "
268912|NCT00032175|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if gemcitabine is more effective with or~     without capecitabine in treating pancreatic cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or~     without capecitabine in treating patients who have locally advanced or metastatic pancreatic~     cancer.~   "
268913|NCT00032162|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining liposomal doxorubicin with~     carboplatin in treating patients who have gynecologic cancer.~   "
268914|NCT00032149|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~     Colony-stimulating factors such as filgrastim may increase the number of immune cells found~     in bone marrow or peripheral blood and may help a person's immune system recover from the~     side effects of chemotherapy.~      PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination~     chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.~   "
268915|NCT00032136|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     exemestane may fight breast cancer by reducing the production of estrogen. It is not yet~     known if exemestane is more effective than tamoxifen in preventing the recurrence of breast~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of~     tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage~     breast cancer.~   "
268916|NCT00032123|"~     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor~     cells and slow the growth of the tumor.~      PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have~     locally advanced or metastatic stomach cancer or cancer of the gastroesophageal junction.~   "
268917|NCT00032110|"~     Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow~     the growth of the tumor. Phase II trial to study the effectiveness of erlotinib in treating~     patients who have recurrent or metastatic colorectal cancer.~   "
268918|NCT00032097|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     motexafin gadolinium may make the tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients~     with glioblastoma multiforme who are undergoing radiation therapy to the brain.~   "
268919|NCT00032084|"~     RATIONALE: A program that includes bupropion may be more effective in helping early-stage~     lung cancer patients to quit smoking. It is not yet known if a program to quit smoking is~     more effective with or without bupropion.~      PURPOSE: Randomized phase III trial to determine the effectiveness of a program to quit~     smoking with or without bupropion in treating patients who have undergone surgery for stage I~     or stage II non-small cell lung cancer.~   "
268920|NCT00032058|"~     RATIONALE: Imaging procedures such as magnetic resonance imaging (MRI) and magnetic resonance~     spectroscopic imaging (MRSI) may improve the ability to detect the extent of prostate cancer.~     It is not yet known if MRI combined with MRSI is more effective than MRI alone in detecting~     the extent of prostate cancer.~      PURPOSE: Diagnostic trial to compare the effectiveness of combining MRI with MRSI to that of~     MRI alone in determining the extent of prostate cancer in patients who are scheduled to~     undergo surgery to remove the prostate gland.~   "
268921|NCT00032045|"~     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill~     tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Combining vaccine therapy with~     a monoclonal antibody may cause a stronger immune response and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with~     monoclonal antibody therapy in treating patients who have stage IV melanoma.~   "
268922|NCT00032032|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy and radiation therapy may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation~     therapy when given with combination chemotherapy and to see how well they work in treating~     patients with non-small cell lung cancer that cannot be surgically removed.~   "
268923|NCT00032019|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Combining rituximab with combination chemotherapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination~     chemotherapy in treating patients who have previously untreated non-Hodgkin's lymphoma.~   "
268924|NCT00032006|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as~     goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing~     androgens. Internal radiation uses radioactive material placed directly into or near a tumor~     to kill tumor cells. Combining hormone therapy with internal radiation may be effective in~     treating locally recurrent prostate cancer.~      PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal~     radiation in treating patients who have locally recurrent prostate cancer following~     external-beam radiation therapy.~   "
268925|NCT00031993|"~     This phase II trial is studying erlotinib to see how well it works in treating patients with~     persistent or recurrent cancer of the cervix. Biological therapies such as erlotinib may~     interfere with the growth of tumor cells and slow the growth of the tumor~   "
268926|NCT00031980|"~     RATIONALE: Cyclosporine may improve low blood counts caused by hematologic cancer.~      PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who~     have low blood counts caused by hematologic cancer.~   "
268927|NCT00031967|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     melatonin may make tumor cells more sensitive to radiation therapy and may protect normal~     cells from the side effects of radiation therapy.~      PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with~     radiation therapy in treating patients who have brain metastases.~   "
268928|NCT00031941|"~     RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have~     solid tumors and/or lymphoma that did not respond to previous therapy.~   "
268929|NCT00031928|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who~     have progressive or refractory meningeal tumors.~   "
268930|NCT00031915|"~     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes~     necessary for cancer cell growth.~      PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients~     who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma.~   "
268931|NCT00031902|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining rituximab with chemotherapy may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy~     in treating patients who have HIV-related non-Hodgkin's lymphoma.~   "
268932|NCT00031876|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to determine the effectiveness of combining capecitabine and~     paclitaxel in treating patients who have metastatic breast cancer.~   "
268933|NCT00031863|"~     RATIONALE: Rofecoxib may stop the growth of cancer by stopping blood flow to the tumor and~     killing tumor cells that remain after surgery. It is not yet known if rofecoxib is effective~     in treating colorectal cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of giving rofecoxib after~     surgery in treating patients who have stage II or stage III colorectal cancer.~   "
268934|NCT00031850|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of raloxifene and goserelin may be effective in~     preventing breast cancer.~      PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and~     goserelin in preventing breast cancer in women who have a family history of breast cancer.~   "
268935|NCT00031837|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may~     help prevent blood clots in patients being treated with gemcitabine for unresectable or~     metastatic pancreatic cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or~     without dalteparin in treating patients who have unresectable or metastatic pancreatic~     cancer.~   "
268936|NCT00031824|"~     RATIONALE: Hydroxychloroquine may decrease the immune response and be effective in treating~     chronic graft-versus-host disease. It is not yet known if standard therapy for~     graft-versus-host disease is more effective with or without hydroxychloroquine.~      PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy alone~     with that of standard therapy plus hydroxychloroquine in treating patients who have newly~     diagnosed chronic graft-versus-host disease.~   "
268937|NCT00031798|"~     RATIONALE: Methylphenidate may decrease side effects of radiation therapy. It is not yet~     known if methylphenidate is effective in improving quality of life in patients with primary~     or metastatic brain tumors.~      PURPOSE: Randomized phase III trial to determine the effectiveness of methylphenidate in~     improving quality of life in patients who have brain tumors and are undergoing radiation~     therapy.~   "
268938|NCT00031772|"~     RATIONALE: Telephone counseling by breast cancer survivors may enhance the well-being and~     quality of life of women who have recurrent breast cancer.~      PURPOSE: Randomized clinical trial to study the effectiveness of telephone counseling by~     breast cancer survivors on the well-being of women who have recurrent breast cancer.~   "
268939|NCT00031759|"~     RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the~     development of cancer. Applying topical imiquimod before abnormal cervical cells are removed~     may be effective in preventing cervical cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of applying topical imiquimod~     before abnormal cervical cells are removed in preventing cervical cancer in patients who have~     recurrent or persistent cervical neoplasia.~   "
268940|NCT00031746|"~     RATIONALE: Soy protein supplement may prevent or delay the development of prostate cancer in~     patients who have elevated prostate-specific antigen (PSA) levels.~      PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement~     in preventing prostate cancer in patients who have elevated PSA levels.~   "
268941|NCT00031733|"~     RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining~     vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor~     cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy~     with interleukin-12 and either alum or sargramostim in treating patients who have undergone~     surgery for stage II, stage III, or stage IV melanoma.~   "
268942|NCT00031720|"~     RATIONALE: Soy protein supplement may be effective in reducing hot flushes in postmenopausal~     women who are receiving tamoxifen for breast disease.~      PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement~     in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast~     disease such as ductal hyperplasia or breast cancer.~   "
268943|NCT00031694|"~     Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in~     treating patients who have locally advanced unresectable or metastatic pancreatic cancer.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells~     more sensitive to the drug.~   "
268944|NCT00031681|"~     This phase I trial is studying the side effects and best dose of giving~     7-hydroxystaurosporine together with irinotecan hydrochloride in treating patients with~     metastatic or unresectable solid tumors, including triple-negative breast cancer (currently~     enrolling only patients with triple-negative breast cancer since 6/8/2007). Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Giving 7-hydroxystaurosporine together with irinotecan hydrochloride may help kill more~     cancer cells by making tumor cells more sensitive to the drug.~   "
268960|NCT00030784|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin with~     ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.~   "
268945|NCT00031655|"~     The reason for doing this study is to determine whether a new method of blood stem cell~     transplant (also known as bone marrow transplant) is able to treat acute lymphocytic~     leukemia. Blood stem cells are the seed cells necessary to make all blood cells. This new~     method of transplant uses a combination of low dose radiation and chemotherapy that may be~     less toxic and cause less harm than a conventional transplant. This lower dose transplant is~     called a nonmyeloablative transplant. Researchers want to see if using less radiation and~     less chemotherapy combined with new immune suppressing drugs after the transplant will help a~     stem cell transplant to work. Researchers hope that this treatment will cure acute~     lymphocytic leukemia with fewer side effects. Researchers are hoping to see a mixture of~     recipient and donor blood cells after transplant. This mixture of donor and recipient blood~     cells is called mixed chimerism. Researchers hope that donor cells will attack and~     eliminate the leukemia. This is called the graft-versus-leukemia effect. In addition, after~     the transplant, white blood cells from the donor may be given to enhance or boost the~     graft-versus-leukemia effect, and hopefully remove all remaining cancer cells. This study is~     being done because at the present time blood stem cell transplantation (or bone marrow~     transplantation) is the only known curative therapy for acute lymphocytic leukemia. Because~     of age or underlying health status acute lymphocytic leukemia patients have a higher~     likelihood of experiencing severe harm from a conventional blood stem cell transplant.~     Researchers are doing this study to see if this new nonmyeloablative method of low dose~     radiation and low dose chemotherapy given before transplant and immune suppressive drugs~     after transplant will help make the transplant safer and also cure acute lymphocytic leukemia~   "
268946|NCT00031642|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver~     cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal~     antibodies can locate and deliver radioactive cancer-killing substances.~      PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal~     antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not~     responded to high-dose chemotherapy and autologous stem cell transplantation.~   "
268947|NCT00031629|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating~     factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in~     bone marrow or peripheral blood and may help a person's immune system recover from the side~     effects of chemotherapy. This phase II trial is studying how well combination chemotherapy~     plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent~     cancer of the uterus.~   "
268948|NCT00031616|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of NB1011 in treating patients who have~     metastatic or recurrent colorectal cancer that has not responded to previous treatment.~   "
268949|NCT00031590|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or~     die. Combining low-dose radiation therapy with combination chemotherapy may be effective in~     treating primitive neuroectodermal tumor and medulloblastoma.~      PURPOSE: This phase II trial is studying giving low-dose radiation therapy together with~     combination chemotherapy after surgery to see how well it works in treating children with~     newly diagnosed primitive neuroectodermal tumor or medulloblastoma.~   "
268950|NCT00031577|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Paclitaxel may make the tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation~     therapy in treating children who have newly diagnosed brain stem glioma.~   "
268951|NCT00031564|"~     RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells~     may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a~     person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2~     may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with~     interleukin-2 in treating patients who have stage IV kidney cancer.~   "
268952|NCT00030914|"~     RATIONALE: Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes. It~     is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving~     hot flashes.~      PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with~     that of venlafaxine in treating women who are experiencing hot flashes.~   "
268953|NCT00030901|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. The use of selenium may be an effective way to prevent prostate cancer~     in patients who have neoplasia of the prostate.~      PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing~     prostate cancer in patients who have neoplasia of the prostate.~   "
268954|NCT00030888|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of UCN-01 in treating patients who have~     unresectable stage III or stage IV kidney cancer.~   "
268955|NCT00030875|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary~     for cancer cell growth.~      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who~     have previously untreated or relapsed mantle cell lymphoma.~   "
268956|NCT00030862|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and cisplatin in~     treating patients who have locally advanced unresectable or metastatic cancer of the~     esophagus that has not been previously treated.~   "
268957|NCT00030849|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.~     Combining chemotherapy with interferon alfa may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon~     alfa in treating patients who have cutaneous T-cell lymphoma.~   "
268958|NCT00030823|"~     RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of~     breast cancer.~      PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who~     are at high risk for breast cancer recurrence.~   "
268959|NCT00030810|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it~     can be removed during surgery.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung~     cancer.~   "
268961|NCT00030771|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to~     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. It is not yet known if chemotherapy plus radiation therapy is more effective than~     chemotherapy alone before surgery in treating non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying docetaxel and cisplatin with or without~     radiation therapy to see how well they work when given before surgery in treating patients~     with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest.~   "
268962|NCT00030758|"~     RATIONALE: Colony-stimulating factors, such as filgrastim or pegfilgrastim, may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy. It is not yet known whether~     filgrastim or pegfilgrastim is more effective than standard treatment in preventing~     neutropenia in women who are receiving adjuvant chemotherapy for breast cancer.~      PURPOSE: Randomized phase IV trial to compare the effectiveness of filgrastim or~     pegfilgrastim with that of standard treatment in preventing neutropenia in women who are~     receiving chemotherapy after undergoing surgery for breast cancer.~   "
268963|NCT00030745|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so~     that it can be removed during surgery.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have mesothelioma of the lung.~   "
268964|NCT00030732|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if gemcitabine is more effective with or~     without capecitabine in treating pancreatic cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or~     without capecitabine in treating patients who have advanced pancreatic cancer.~   "
268965|NCT00030719|"~     RATIONALE: Colony-stimulating factors such as filgrastim may increase the number of immune~     cells found in bone marrow or peripheral blood and may help a person's immune system recover~     from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell~     transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Combining isotretinoin and~     monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet~     known which treatment regimen is more effective in treating neuroblastoma.~      PURPOSE: This randomized phase III trial is studying how well combination chemotherapy with~     or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed~     by isotretinoin with or without monoclonal antibody work in treating patients with~     neuroblastoma.~   "
268966|NCT00030706|"~     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop~     tumor cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who~     have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary~     peritoneal cancer.~   "
268967|NCT00030693|"~     Randomized phase I trial to compare the effectiveness of two different vaccines given~     directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may~     make the body build an immune response to kill tumor cells. Infusing the vaccine directly~     into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet~     known which vaccine may be more effective in treating metastatic solid tumors~   "
268968|NCT00030680|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients~     who have aggressive fibromatoses.~   "
268969|NCT00030654|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as~     luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the~     adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to~     stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with~     chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the~     same time as hormone therapy is more effective than chemotherapy given after hormone therapy~     in treating prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the~     same time as hormone therapy with that of chemotherapy given after hormone therapy in~     treating patients who have prostate cancer.~   "
268970|NCT00030641|"~     RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor~     cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of~     docetaxel by making the tumor cells more sensitive to the drug. It is not yet known if~     docetaxel is more effective with or without oblimersen in treating non-small cell lung~     cancer.~      PURPOSE: Randomized phase II/III trial to compare the effectiveness of docetaxel with or~     without oblimersen in treating patients who have relapsed or refractory non-small cell lung~     cancer that has been previously treated.~   "
268971|NCT00030628|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may~     be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is~     not yet known if radiosurgery is more effective with or without whole-brain radiation therapy~     in treating brain metastases.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or~     without whole-brain radiation therapy in treating patients who have brain metastases.~   "
268972|NCT00030615|"~     This phase I trial is studying the side effects and best dose of decitabine in treating~     patients with advanced solid tumors that have not responded to previous treatment. Drugs used~     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die~   "
268991|NCT00030264|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining methotrexate with vinblastine may be effective treatment~     for neurofibromatosis type 1 associated with progressive plexiform neurofibromas.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have neurofibromatosis type 1 associated with progressive plexiform~     neurofibromas.~   "
268973|NCT00030589|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Photodynamic therapy uses light and drugs that make cancer cells~     more sensitive to light to kill cancer cells. Photosensitizing drugs, such as methoxsalen,~     are absorbed by cancer cells and, when exposed to light, become active and kill the cancer~     cells. Combining chemotherapy with photodynamic therapy may be an effective treatment for~     cutaneous T-cell lymphoma.~      PURPOSE: Randomized phase II trial to study the effectiveness of combining different doses of~     bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA~     cutaneous T-cell lymphoma.~   "
268974|NCT00030576|"~     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor~     cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may~     kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in~     treating patients who have recurrent or metastatic head and neck cancer.~   "
268975|NCT00030563|"~     RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells.~     Combining radiofrequency ablation with surgery may kill more tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any~     remaining tumor cells.~      PURPOSE: Phase II trial to determine the effectiveness of surgery with or without~     radiofrequency ablation followed by irinotecan in treating patients who have colorectal~     cancer that is metastatic to the liver.~   "
268976|NCT00030550|"~     RATIONALE: Thalidomide may be an effective treatment for anemia caused by myelodysplastic~     syndrome.~      PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating~     anemia in patients who have myelodysplastic syndrome.~   "
268977|NCT00030537|"~     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor~     cells and slow the growth of the tumor.~      PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have~     locally advanced or metastatic breast cancer.~   "
268978|NCT00030511|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so~     that it can be removed during surgery.~      PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with~     fluorouracil before surgery in treating patients who have primary or recurrent bile duct~     cancer.~   "
268979|NCT00030498|"~     Phase I trial to study the effectiveness of erlotinib in treating patients who have~     metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies~     such as erlotinib may interfere with the growth of tumor cells and slow the growth of the~     tumor~   "
268980|NCT00030485|"~     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor~     cells and slow the growth of the tumor.~      PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who~     have locally advanced and/or metastatic endometrial cancer.~   "
268981|NCT00030472|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients~     who have persistent or recurrent cancer of the cervix.~   "
268982|NCT00030459|"~     RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably.~     It is not yet known if palliative therapy is more effective with or without chemotherapy in~     treating patients who have malignant mesothelioma.~      PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or~     without different chemotherapy regimens in treating patients who have malignant mesothelioma.~   "
268983|NCT00030433|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have extensive-stage small cell lung cancer.~   "
268984|NCT00030407|"~     RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining chemotherapy and celecoxib may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of celecoxib and docetaxel in treating~     patients who have non-small cell lung cancer.~   "
268985|NCT00030394|"~     This phase II trial is studying imatinib mesylate to see how well it works in treating~     patients with chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer~     cells by blocking the enzymes necessary for cancer cell growth~   "
268986|NCT00030355|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of homoharringtonine in treating~     patients who have refractory acute promyelocytic leukemia.~   "
268987|NCT00030342|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. Combining biological therapy with chemotherapy may~     kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of biological therapy combined with~     chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer.~   "
268988|NCT00030303|"~     RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune~     response to kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have chronic myelogenous leukemia.~   "
268989|NCT00030290|"~     RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the~     tumor without affecting the surrounding tissue.~      PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating~     patients who have prostate cancer that has not spread beyond the prostate.~   "
268990|NCT00030277|"~     RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the~     tumor without affecting the surrounding tissue.~      PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in~     treating patients with locally recurrent prostate cancer.~   "
268992|NCT00030108|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in~     treating young patients with relapsed or refractory solid tumors or leukemia.~   "
268993|NCT00030095|"~     RATIONALE: 2-Methoxyestradiol may stop the growth of cancer by stopping blood flow to the~     tumor.~      PURPOSE: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients~     who have advanced solid tumors.~   "
268994|NCT00030082|"~     RATIONALE: Heating melphalan to several degrees above body temperature and infusing it to the~     affected area directly around the tumor may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan~     in treating patients who have unresectable liver cancer.~   "
268995|NCT00029029|"~     RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells~     and may help to relieve pain caused by bone metastases.~      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving~     pain in patients who have bone metastases.~   "
268996|NCT00029003|"~     Phase II trial to study the effectiveness of gefitinib in treating patients who have stage~     IIIB or stage IV non-small cell lung cancer. Biological therapies such as gefitinib may~     interfere with the growth of the tumor cells and slow the growth of non-small cell lung~     cancer~   "
268997|NCT00028990|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop~     tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as~     bevacizumab, can block cancer growth in different ways. Some block the ability of cancer~     cells to grow and spread. Others find cancer cells and help kill them or deliver~     cancer-killing substances to them. It is not yet known whether paclitaxel works better with~     or without bevacizumab in treating breast cancer.~      PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without~     bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.~   "
268998|NCT00028977|"~     RATIONALE: The Chinese herb Scutellaria barbata contains ingredients that may slow the growth~     of cancer cells and may be an effective treatment for metastatic breast cancer.~      PURPOSE: Phase I/II trial to study the effectiveness of Scutellaria barbata in treating women~     who have metastatic breast cancer.~   "
268999|NCT00028964|"~     RATIONALE: Herbs used in traditional Chinese medicine may decrease the side effects of~     chemotherapy.~      PURPOSE: Randomized phase I/II trial to study the effectiveness of herbs used in traditional~     Chinese medicine in decreasing the side effects of chemotherapy after surgery in women who~     have stage I, stage II, or early stage III breast cancer.~   "
269000|NCT00028951|"~     RATIONALE: Fibrin sealant may decrease lymphedema following surgery to remove lymph nodes in~     the groin by helping to seal the lymphatic vessels. It is not yet known if fibrin sealant is~     effective in decreasing lymphedema following surgery to remove lymph nodes.~      PURPOSE: Randomized phase III trial to determine the effectiveness of fibrin sealant in~     reducing lymphedema following surgical removal of lymph nodes in patients who have cancer of~     the vulva.~   "
269001|NCT00028912|"~     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary~     for tumor cell growth. Drugs used in chemotherapy such as carboplatin use different ways to~     stop tumor cells from dividing so they stop growing or die. Bortezomib may help carboplatin~     kill more tumor cells by making tumor cells more sensitive to the drug.~      PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with carboplatin in~     treating patients who have recurrent or progressive ovarian epithelial, primary peritoneal,~     or fallopian tube cancer.~   "
269002|NCT00028899|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can~     locate cancer cells and either kill them or deliver cancer-killing substances to them without~     harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may~     kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with~     combination chemotherapy in treating children who have relapsed or refractory acute myeloid~     leukemia or myelodysplastic syndrome.~   "
269003|NCT00028886|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping~     blood flow to the cancer. Peripheral blood stem cell transplant using stem cells from the~     patient or a donor may be able to replace immune cells that were destroyed by chemotherapy~     used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer~     cells (graft-versus-tumor effect). It is not yet known whether chemotherapy followed by~     peripheral blood stem cell transplant is more effective with or without thalidomide in~     treating multiple myeloma.~      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with~     thalidomide to see how well it works compared with giving combination chemotherapy without~     thalidomide in treating patients with multiple myeloma.~   "
269004|NCT00028873|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining~     R101933 with paclitaxel or docetaxel may reduce resistance to the drug and allow the tumor~     cells to be killed.~      PURPOSE: Phase II trial to study the effectiveness of combining R101933 with either~     paclitaxel or docetaxel in treating patients who have metastatic breast cancer that has not~     responded to previous chemotherapy.~   "
269005|NCT00028860|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following~     surgery in treating patients who have urinary tract cancer.~   "
269006|NCT00028847|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes~     necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop~     cancer cells from dividing so they stop growing or die. Combining imatinib mesylate and~     chemotherapy may kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate plus cytarabine in~     treating patients who have newly diagnosed chronic myeloid leukemia.~   "
269007|NCT00028834|"~     This phase II trial is to see if combining gemcitabine with bevacizumab works in treating~     patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different~     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies,~     such as bevacizumab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or deliver~     cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill~     more tumor cells~   "
269008|NCT00028821|"~     Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have~     advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by~     stopping blood flow to the tumor~   "
269009|NCT00028795|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Giving chemotherapy together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation~     therapy after surgery followed by chemotherapy alone works in children with newly diagnosed~     astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.~   "
269010|NCT00028782|"~     This phase II trial is studying how well EF5 works in detecting oxygen level and blood~     vessels in tumor cells of patients who are undergoing photodynamic therapy for~     intraperitoneal or pleural cancer. Diagnostic procedures using EF5 to detect oxygen level and~     blood vessels in tumor cells may help to improve the way photodynamic therapy is given~   "
269011|NCT00028769|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs~     such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from~     producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone~     therapy in treating patients who have metastatic prostate cancer.~   "
269012|NCT00028756|"~     Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy~     with that of adjuvant chemotherapy given when the cancer returns in treating patients who~     have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of~     the bladder urothelium. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. Combining more than one drug and giving them after~     surgery may kill any remaining tumor cells. It is not yet known if adjuvant chemotherapy is~     more effective when given immediately after radical cystectomy (surgery to remove the~     bladder) or when the cancer returns.~   "
269013|NCT00028743|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving the drugs in different~     combinations may kill more tumor cells. It is not yet known which combination chemotherapy~     regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian~     tube cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination~     chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian~     epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.~   "
269014|NCT00028730|"~     RATIONALE: Giving chemotherapy and total body irradiation before a donor bone marrow~     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor~     can make an immune response against the body's normal cells. Giving antithymocyte globulin~     and removing the T cells from the donor cells before transplant may stop this from happening.~      PURPOSE: This phase II trial is studying how well total-body irradiation and chemotherapy~     followed by T-cell depleted donor bone marrow transplant works in treating young patients~     with hematologic cancer.~   "
269015|NCT00028717|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. It~     is not yet known if combination chemotherapy plus filgrastim is more effective with or~     without rituximab in treating non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to determine the effectiveness of combination~     chemotherapy plus filgrastim with or without rituximab in treating older patients who have~     non-Hodgkin's lymphoma.~   "
269016|NCT00028704|"~     RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less~     invasive than mastectomy and may improve the quality of life. It is not yet known if~     breast-conserving treatments are as effective as mastectomy followed by radiation therapy in~     treating locally advanced breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy~     with mastectomy followed by radiation therapy in treating women who have locally advanced~     breast cancer that has been previously treated with chemotherapy.~   "
269017|NCT00028691|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. It is not yet known if chlorambucil is more effective than radiation therapy in~     treating follicular lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of~     radiation therapy in treating patients who have stage III or stage IV follicular lymphoma~     that has not been previously treated.~   "
269018|NCT00028665|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or~     die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known if~     combining rituximab with cyclophosphamide is more effective than cyclophosphamide alone in~     stimulating peripheral stem cells for transplantation.~      PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide with or~     without rituximab followed by chemotherapy and peripheral stem cell transplantation works in~     treating patients with recurrent non-Hodgkin's lymphoma.~   "
269020|NCT00028639|"~     RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for~     cancer cell growth.~      PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have~     metastatic breast cancer.~   "
269021|NCT00028626|"~     RATIONALE: Embolization blocks blood flow to part of an organ and/or tumor. Blocking the~     portal vein on one side of the liver may cause the opposite side of the liver to increase in~     size and decrease the risk of liver failure following surgery.~      PURPOSE: Phase II trial to study the effectiveness of portal vein embolization in treating~     patients who have liver metastases from primary colorectal cancer.~   "
269022|NCT00028600|"~     RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor~     may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor~     cells. The donated stem cells may also help destroy any remaining cancer cells~     (graft-versus-tumor effect).~      PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant~     followed by donor peripheral stem cell transplant works in treating patients with multiple~     myeloma.~   "
269023|NCT00028587|"~     Phase I trial to study the effectiveness of combining PS-341 and combination chemotherapy in~     treating patients who have advanced solid tumors. PS-341 may stop the growth of tumor cells~     by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     PS-341 and chemotherapy may kill more tumor cells~   "
269024|NCT00028574|"~     RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate~     cancer. It is not yet known which regimen of gabapentin is most effective in treating hot~     flashes.~      PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating~     men who have prostate cancer.~   "
269025|NCT00028561|"~     This phase I trial is studying the side effects and best dose of BMS-247550 when given~     together with carboplatin in treating patients with recurrent or refractory solid tumors.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug may kill more tumor cells~   "
269026|NCT00028548|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have~     advanced solid tumors.~   "
269027|NCT00028535|"~     Phase I trial to study the effectiveness of interleukin-12, paclitaxel, and trastuzumab in~     treating patients who have solid tumors. Interleukin-12 may kill tumor cells by stopping~     blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either~     kill them or deliver tumor-killing substances to them without harming normal cells. Combining~     interleukin-12, chemotherapy, and monoclonal antibody therapy may kill more tumor cells.~   "
269028|NCT00028522|"~     This phase I trial is studying the side effects and best dose of R(+)XK469 in treating~     patients with advanced neuroblastoma. Drugs used in chemotherapy work in different ways to~     stop cancer cells from dividing so they stop growing or die.~   "
269029|NCT00028509|"~     RATIONALE: Assessing the effects of methotrexate on brain function in children may improve~     the ability to plan treatment and decrease side effects.~      PURPOSE: Clinical trial to compare brain function of children who have been previously~     treated with methotrexate.~   "
269030|NCT00028496|"~     Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in~     treating patients who have advanced or metastatic cancer. Vaccines may make the body build an~     immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may~     increase the number of immune cells found in bone marrow or peripheral blood. Combining~     vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may~     kill more tumor cells~   "
269031|NCT00028028|"~     Randomized phase II trial to compare the effectiveness of different doses of CCI-779 in~     treating patients who have extensive-stage small cell lung cancer. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die~   "
269032|NCT00028015|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have~     recurrent or metastatic colorectal cancer.~   "
269033|NCT00028002|"~     Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in~     treating patients who are undergoing surgery for primary or recurrent malignant~     gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by~     blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after~     surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining~     after surgery.~   "
269034|NCT00027989|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with~     gemcitabine in treating women who have metastatic breast cancer.~   "
269035|NCT00027976|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of celecoxib may be an effective way to prevent~     actinic keratoses.~      PURPOSE: Randomized phase II/III trial to determine the effectiveness of celecoxib in~     preventing skin cancer in patients who have actinic keratoses.~   "
269036|NCT00027963|"~     RATIONALE: Gabapentin may be effective in relieving pain and other symptoms of peripheral~     neuropathy. It is not yet known if gabapentin is effective in treating peripheral neuropathy~     in cancer patients undergoing chemotherapy.~      PURPOSE: Randomized phase III trial to determine the effectiveness of gabapentin in treating~     pain and other symptoms of peripheral neuropathy in cancer patients undergoing chemotherapy.~   "
269052|NCT00027716|"~     RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for~     tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who~     have advanced or metastatic sarcoma.~   "
270121|NCT00051922|"~     The purpose of the study is to determine the safety of a new HIV vaccine and to evaluate the~     immune response to the vaccine. Only some HIV genes are used to make the vaccine and~     therefore the vaccine cannot itself cause HIV or AIDS.~   "
269037|NCT00027937|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~     Biological therapies such as interleukin-2 use different ways to stimulate the immune system~     and stop cancer cells from growing.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral~     stem cell transplantation, and interleukin-2 in treating patients who have solid tumors or~     lymphoma.~   "
269038|NCT00027911|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Colony-stimulating factors such as sargramostim increase the number of immune cells found in~     bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may be effective~     in treating soft tissue sarcoma.~      PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with~     sargramostim in treating patients who have stage II, stage III, or stage IV soft tissue~     sarcoma.~   "
269039|NCT00027898|"~     Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their~     growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Phase I trial to study the effectiveness of combining bortezomib~     with carboplatin and etoposide in treating patients who have advanced solid tumors that have~     not responded to previous treatment~   "
269040|NCT00027885|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or deliver cancer-killing substances to them.~     Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: This randomized phase II trial is to see if docetaxel with or without bevacizumab~     followed by surgery, radiation therapy, and combination chemotherapy works better in treating~     patients who have stage III or stage IV breast cancer.~   "
269041|NCT00027872|"~     Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their~     growth. Phase II trial to study the effectiveness of tipifarnib in treating older patients~     who have previously untreated acute myeloid leukemia~   "
269042|NCT00027859|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as~     ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die. It is not yet known~     whether hormone therapy is more effective than combination chemotherapy in treating prostate~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that~     of combination chemotherapy in treating patients who have prostate cancer that has been~     previously treated with androgen suppression.~   "
269043|NCT00027846|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during~     surgery.~      PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy~     either alone or after chemotherapy and second surgery in treating children who have undergone~     surgery for localized ependymoma.~   "
269044|NCT00027833|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and~     vaccine therapy.~      PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine~     therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients~     who have metastatic colorectal cancer.~   "
269045|NCT00027820|"~     This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant,~     that may be less toxic, is able to treat underlying blood cancer. Stem cells are seed cells~     necessary to make blood cells. Researchers want to see if using less radiation and less~     chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work.~     Researchers are hoping to see a mixture of recipient and donor stem cells after transplant.~     This mixture of donor and recipient stem cells is called mixed-chimerism. Researchers hope~     to see these donor cells eliminate tumor cells. This is called a graft-versus-leukemia~     response.~   "
269046|NCT00027807|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Combining different types of biological therapies may kill more~     tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining different biological~     therapies in treating women who have stage IV breast cancer.~   "
269047|NCT00027794|"~     RATIONALE: Radical prostatectomy may be an effective treatment for locally advanced prostate~     cancer.~      PURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating~     patients who have locally advanced prostate cancer.~   "
269048|NCT00027781|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have~     progressive prostate cancer that has not responded to hormone therapy.~   "
269049|NCT00027768|"~     RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver~     cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more~     effective than no further treatment after surgery.~      PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in~     treating patients who have undergone surgery for liver cancer.~   "
269050|NCT00027742|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.~     Combining chemotherapy with interferon alfa may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon~     alfa in treating patients who have stage III or stage IV melanoma.~   "
269051|NCT00027729|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in~     treating patients who have advanced colorectal cancer that has not responded to irinotecan.~   "
269053|NCT00027703|"~     This randomized phase II trial is to see if combination chemotherapy works better with or~     without bevacizumab in treating patients who have malignant mesothelioma. Drugs used in~     chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or~     die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help~     kill them or deliver cancer-killing substances to them. It is not yet known if combination~     chemotherapy works better with or without bevacizumab in treating malignant mesothelioma.~   "
269054|NCT00027690|"~     Phase II trial to study the effectiveness of gefitinib in treating patients who have~     persistent or recurrent endometrial cancer. Biological therapies such as gefitinib may~     interfere with the growth of tumor cells and slow the growth of endometrial cancer.~   "
269055|NCT00027677|"~     RATIONALE: Halofuginone hydrobromide may stop the growth of solid tumors by stopping blood~     flow to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of halofuginone hydrobromide in treating~     patients who have progressive advanced solid tumors.~   "
269056|NCT00027664|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Thalidomide may~     stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if~     interferon alfa is more effective with or without thalidomide in treating metastatic kidney~     cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of interferon alfa with or~     without thalidomide in treating patients who have metastatic kidney cancer.~   "
269057|NCT00027638|"~     RATIONALE: Thalidomide may stop the growth of neuroendocrine tumors by stopping blood flow to~     the tumor.~      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who~     have metastatic neuroendocrine tumors.~   "
269058|NCT00027625|"~     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer~     cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining gefitinib with chemotherapy~     may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining gefitinib with temozolomide in~     treating patients who have malignant primary glioma.~   "
269059|NCT00027586|"~     RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an~     effective treatment for metastatic melanoma.~      PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients~     who have metastatic melanoma.~   "
269060|NCT00027573|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune~     cells that were destroyed by chemotherapy used to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by donor~     peripheral stem cell transplantation in treating patients who have metastatic or unresectable~     kidney cancer.~   "
269061|NCT00027560|"~     RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a~     monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem~     cell transplant helps stop the growth of cancer cells. It also stops the patient's immune~     system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving cyclosporine after the transplant may stop this from~     happening.~      PURPOSE: This phase II trial is studying how well fludarabine, melphalan, alemtuzumab, and~     peripheral stem cell transplant work in treating patients with hematologic cancer.~   "
269062|NCT00027547|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may be able to replace~     immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the~     transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and donor~     white blood cells may prevent this from happening.~      PURPOSE: Phase I/II trial to determine the effectiveness of combination chemotherapy and~     total-body irradiation followed by peripheral stem cell transplantation in treating patients~     who have acute lymphoblastic leukemia.~   "
269063|NCT00027534|"~     RATIONALE: Vaccines made from a person's white blood cells that have been treated in the~     laboratory may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have advanced or metastatic cancer.~   "
269064|NCT00027495|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. Curcumin may be effective in preventing the development of colon~     cancer.~      PURPOSE: Phase I trial to determine the dose amount of curcumin that can be tolerated to help~     in preventing colon cancer in healthy men and women.~   "
269065|NCT00026533|"~     RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the~     tumor.~      PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have~     thyroid cancer.~   "
269066|NCT00026494|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in~     treating patients who have recurrent brain metastases.~   "
269067|NCT00026468|"~     RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in~     patients who have familial adenomatous polyposis.~      PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in~     preventing the development and growth of polyps in patients who have familial adenomatous~     polyposis.~   "
269068|NCT00026442|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of~     capecitabine in treating women who have advanced or metastatic breast cancer.~   "
269069|NCT00026416|"~     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.~     Interferon alfa may interfere with the growth of cancer cells. Combining interferon alfa and~     thalidomide may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa and~     thalidomide in treating patients who have undergone surgery for soft tissue sarcoma or bone~     sarcoma.~   "
270122|NCT00051961|"~     This study will examine the effects of the drug Ropinirole on spinal cord reflexes and on~     symptoms of restless legs syndrome (RLS). Patients with RLS have uncomfortable sensations in~     the legs, usually in the evening or early part of the night. Most patients also have periodic~     involuntary leg movements. The condition tends to worsen over time, resulting in severe~     discomfort and sleep disturbances. Ropinirole affects chemical messengers thought to be~     involved in spinal cord function and in modulating RLS symptoms.~      Healthy normal volunteers and patients with RLS between 18 and 80 years of age may be~     eligible for this study. Patients must have mild to moderate RLS and periodic limb movements.~     All candidates will be screened with a medical history, physical and neurological~     evaluations, electromyogram (see below), polysomnogram (see below), electrocardiogram (ECG),~     and blood and urine tests. They may also have magnetic resonance imaging (MRI) or~     computerized tomography (CT) scans and a chest x-ray. Participants must stop taking all~     medications prohibited by the study for at least 1 week before the study starts and~     throughout its duration.~      The study will last approximately 2 to 3 weeks for healthy volunteers and 7 to 8 weeks for~     patients. Participants will undergo the following baseline evaluations:~     electroencephalography (EEG), a measure of brain wave activity; polysomnography (PSG), an~     overnight sleep study; electromyography (EMG), a measure of muscle activity; and spinal~     flexor reflex studies (spinal cord responses to electrical stimulation). For these studies,~     several electrodes are attached to the scalp or to the legs and arms using a cream that helps~     conduct brain signals through the cables to be recorded. The nervous system activity can be~     assessed at rest or after stimulation with an electric current. For EMG, a small needle is~     inserted into a few muscles and the subject is asked to relax or to contract the muscles. The~     electrical activity of the muscle cells is recorded and analyzed by a computer. Spinal flexor~     reflex studies usually involve stimulating the nerves in the legs with very brief electric~     currents of mild to moderate intensity. Flexor reflex studies will be done early in the night~     while the subject is awake and also during sleep. Brain, muscle and breathing activities will~     be monitored continuously during sleep.~      A suggested immobilization test (SIT) will be done around 10 p.m. During the test, the~     subject sits still for about 1 hour, while the leg muscle activity is recorded using special~     electronic devices attached to the skin. At the end of the test, volunteers will be asked~     questions about symptoms they may have experienced during the test, and patients will be~     asked questions about their RLS symptoms during the test.~      After the baseline tests, participants will be randomly assigned to take either Ropinirole~     tablets or a placebo (a look-alike inactive substance) daily for 5 weeks. They will be~     admitted to the NIH Clinical Center for 3 to 4 nights at the end of the second week and for 2~     nights at the end of the study to repeat the baseline tests described above. Volunteers will~     take Ropinirole or placebo daily for 1 week. They will be admitted to the Clinical Center for~     3 to 4 days at the beginning and then at the end of the study for repeat testing.~      Medical examinations, ECGs and blood tests will be done at various times during the study for~     safety monitoring. Patients' blood pressure will be monitored weekly. Small amounts of blood~     will be drawn up to three times each day for routine studies, research and drug levels.~     Throughout the study volunteers will complete questionnaires for evaluation of possible RLS~     symptoms, and patients will have their symptoms assessed using a RLS Severity Rating Scale.~     Two weeks after the study ends, participants will be interviewed by telephone about any~     adverse experiences.~   "
269070|NCT00026403|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have locally advanced pancreatic cancer.~   "
269071|NCT00026338|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies such as erlotinib use different ways to~     stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and~     biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more~     effective with or without erlotinib in treating pancreatic cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and~     without erlotinib in treating patients who have unresectable locally advanced or metastatic~     pancreatic cancer.~   "
269072|NCT00026312|"~     This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin,~     and sargramostim to see how well it works compared to isotretinoin alone following stem cell~     transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as~     isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal~     antibodies, such as dinutuximab, may block tumor growth in different ways by targeting~     certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to~     kill cancer cells. It is not yet known if chemotherapy is more effective with or without~     dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating~     neuroblastoma.~   "
269073|NCT00026299|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies such as gefitinib may interfere with the~     growth of the tumor cells and slow the growth of colorectal cancer. Combining chemotherapy~     with gefitinib may kill more tumor cells.~      PURPOSE: Phase I/II trial to compare the effectiveness of chemotherapy with or without~     gefitinib in treating patients who have metastatic or locally recurrent colorectal cancer.~   "
269074|NCT00026247|"~     RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases.~      PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing~     pain in patients who have bone metastases.~   "
269075|NCT00026234|"~     Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in~     treating patients who have colorectal cancer metastatic to the liver. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Giving the drugs in different combinations and different ways may kill more tumor cells.~   "
269076|NCT00026221|"~     This randomized phase II trial is studying giving bevacizumab together with interferon alpha~     to see how well it works compared to giving bevacizumab alone in treating patients with~     metastatic malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block cancer~     growth in different ways. Some block the ability of cancer cells to grow and spread. Others~     find cancer cells and help kill them or deliver cancer-killing substances to them. Interferon~     alpha may interfere with the growth of the cancer cells and slow the growth of the tumor.~     Combining bevacizumab with interferon alpha may kill more tumor cells.~   "
269077|NCT00026208|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together~     with low-dose radiation therapy works in treating patients with stage I or stage IIA~     Hodgkin's lymphoma.~   "
269078|NCT00026195|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Aging may affect the way these drugs work.~      PURPOSE: Phase I trial to determine the relationship between aging and the effectiveness of~     irinotecan in treating patients who have solid tumors.~   "
269079|NCT00026182|"~     Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or~     deliver cancer-killing substances to them without harming normal cells. Interleukin-12 may~     kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white~     blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more~     cancer cells. This randomized phase II trial is comparing how well giving rituximab together~     with two different schedules of interleukin-12 works in treating patients with B-cell~     non-Hodgkin lymphoma.~   "
269080|NCT00026169|"~     Phase I trial to determine the dose of imatinib mesylate that is most effective with the~     least amount of toxic side effects in treating patients who have advanced cancer and kidney~     failure. Imatinib mesylate may stop the growth of cancer cells by stopping the enzyme~     necessary for cancer cell growth. Kidney failure may delay the elimination of imatinib~     mesylate from the body, which may lead to longer drug exposure and increase toxic side~     effects~   "
269081|NCT00026156|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of vinorelbine followed by docetaxel in~     treating patients who have advanced non-small cell lung cancer.~   "
269082|NCT00026143|"~     Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in~     treating patients who have metastatic malignant melanoma. Interleukin-12 may kill tumor cells~     by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill~     cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining~     interleukin-12 and interferon alfa may kill more tumor cells.~   "
269083|NCT00026130|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation~     therapy in treating patients who have locally advanced pancreatic cancer.~   "
269084|NCT00026117|"~     RATIONALE: Shark cartilage extract may help shrink or slow the growth of colorectal cancer or~     breast cancer cells.~      PURPOSE: Randomized phase III trial to determine the effectiveness of shark cartilage in~     treating patients who have advanced colorectal cancer or advanced breast cancer.~   "
269085|NCT00026104|"~     Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and~     radiation therapy with or without tipifarnib in treating patients who have locally advanced~     pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary~     for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an~     effective treatment for pancreatic cancer.~   "
269086|NCT00026091|"~     Phase II trial to study the effectiveness of fenretinide in treating patients who have~     recurrent or metastatic ovarian epithelial or primary peritoneal cancer. Drugs used in~     chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing~   "
269087|NCT00026078|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating~     women who have metastatic breast cancer.~   "
269088|NCT00025675|"~     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor~     cells and slow the growth of CNS tumors.~      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have~     recurrent or progressive CNS tumors.~   "
269089|NCT00025662|"~     This study will evaluate the safety and effectiveness of stem cell transplantation in which~     the donors T lymphocytes have undergone selective depletion. Certain patients with cancers~     of the blood undergo transplantation of donated stem cells to generate new and normally~     functioning bone marrow. In addition to producing the new bone marrow, the donor's~     T-lymphocytes also fight any tumor cells that might have remained in the body. This attack on~     tumor cells is called a graft-versus-leukemia (GVL) effect. However, another type of~     T-lymphocyte from the donor may cause what is called graft-versus-host-disease (GVHD), in~     which the donor cells recognize the patient's cells as foreign and mount an immune response~     to reject them. Selective depletion is a technique that was developed to remove the~     T-lymphocytes that cause harmful GVHD, while keeping those that produce the desirable GVL~     effect.~   "
269090|NCT00025649|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy given before~     surgery followed by peripheral stem cell or bone marrow transplantation in treating infants~     who have newly diagnosed neuroblastoma.~   "
269091|NCT00025636|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give~     higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which~     combination chemotherapy regimen given before peripheral stem cell transplant is more~     effective in treating relapsed Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is comparing different regimens of combination~     chemotherapy followed by peripheral stem cell transplant to see how well they work in~     treating patients with relapsed Hodgkin's lymphoma.~   "
269092|NCT00025623|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug, and giving them before surgery, may~     shrink the tumor so that it can be removed during surgery.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     surgery in treating infants who have newly diagnosed neuroblastoma.~   "
269093|NCT00025610|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of different combination chemotherapy~     regimens in treating infants who have newly diagnosed neuroblastoma.~   "
269094|NCT00025597|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so~     that it can be removed during surgery.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     surgery in treating infants who have newly diagnosed neuroblastoma.~   "
269095|NCT00025584|"~     PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell~     growth. Phase II trial to study the effectiveness of PS-341 in treating women who have~     metastatic breast cancer~   "
269096|NCT00025558|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining temozolomide, thiotepa, and~     carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation~     in treating patients who have brain cancer.~   "
269097|NCT00025519|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the~     transplanted cells can be rejected by the body's tissues. Mycophenolate mofetil, tacrolimus,~     and donor white blood cells may prevent this from happening.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral~     stem cell transplantation in treating patients who have metastatic or recurrent kidney~     cancer.~   "
269098|NCT00025506|"~     This phase II trial is studying how well thalidomide works in treating patients with~     carcinosarcoma of the uterus that has come back or that does not go to remission (decrease or~     disappear but may still be in the body) despite treatment. Thalidomide may stop the growth of~     cancer by stopping blood flow to the tumor.~   "
269099|NCT00025493|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating older women who~     have metastatic breast cancer.~   "
269312|NCT00017121|"~     RATIONALE: Inhaling sargramostim may interfere with the growth of tumor cells and may be an~     effective treatment for melanoma that has spread to the lung.~      PURPOSE: This phase I trial is studying the side effects and best dose of inhaled~     sargramostim in treating patients with melanoma that is metastatic to the lung.~   "
269100|NCT00025480|"~     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by making tumor cells more sensitive to radiation therapy.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells~     either by killing the cells or by stopping them from dividing and may also make tumor cells~     more sensitive to radiation therapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when~     given together with radiation therapy after combination chemotherapy in treating patients~     with stage III non-small cell lung cancer.~   "
269101|NCT00025454|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have~     advanced solid tumors.~   "
269102|NCT00025441|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors.~   "
269103|NCT00025428|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so~     that it can be removed during surgery.~      PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given~     before surgery in treating children who have localized neuroblastoma.~   "
269104|NCT00025415|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Phase I trial to study the effectiveness of imatinib mesylate in treating~     patients who have advanced cancer and liver dysfunction~   "
269105|NCT00025402|"~     RATIONALE: Giving chemotherapy, such as hydroxyurea, cytarabine, idarubicin, and etoposide~     before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer~     cells. It also helps stop the patient's immune system from rejecting the donor's stem cells.~     Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer.~     When the healthy stem cells from a donor are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It~     is not yet known whether chemotherapy is more effective with or without interferon alfa~     and/or bone marrow or stem cell transplant in treating patients with chronic myelogenous~     leukemia.~      PURPOSE: This randomized phase III trial is studying chemotherapy and biological therapy to~     see how well it works compared with chemotherapy, biological therapy, and donor bone marrow~     transplant or autologous stem cell transplant in treating patients with chronic phase chronic~     myelogenous leukemia.~   "
269106|NCT00025389|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work~     in different ways to stop tumor cells from dividing so they stop growing or die. Combining~     monoclonal antibody therapy with chemotherapy before surgery may may shrink the tumor so that~     it can be removed.~      PURPOSE: This phase II trial is to see if bevacizumab, paclitaxel, and carboplatin given~     before surgery work in treating patients who have stage IB, stage II, or stage IIIA non-small~     cell lung cancer.~   "
269107|NCT00025363|"~     Randomized phase II trial to compare the effectiveness of different combination chemotherapy~     regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in~     different ways to stop tumor cells from dividing so they stop growing or die. Combining more~     than one drug may kill more tumor cells~   "
269108|NCT00025337|"~     Randomized phase III trial to compare the effectiveness of combination chemotherapy with or~     without bevacizumab in treating patients who have advanced or metastatic colorectal cancer~     that has been previously treated. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab~     can locate tumor cells and either kill them or deliver tumor-killing substances to them~     without harming normal cells. Combining monoclonal antibody therapy with combination~     chemotherapy may kill more tumor cells. It is not yet known if bevacizumab is more effective~     with or without combination chemotherapy in treating colorectal cancer~   "
269109|NCT00025324|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~     Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, surgery, radiation~     therapy, and bone marrow or peripheral stem cell transplantation in treating patients who~     have primary CNS germ cell tumors.~   "
269110|NCT00025311|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular~     topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the~     lining around the brain.~   "
269111|NCT00025298|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells. Giving~     chemoprotective drugs such as amifostine may protect normal cells from the side effects of~     chemotherapy and radiation therapy.~      PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin~     followed by cisplatin plus radiation therapy with or without amifostine in treating patients~     who have locally advanced cancer of the nasopharynx.~   "
269112|NCT00025285|"~     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.~     Combining thalidomide with chemotherapy may kill more tumor cells and be an effective~     treatment for stage IIIB or stage IV non-small cell lung cancer.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     thalidomide in treating patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
270123|NCT00051909|"~     Study of an investigational medication for the treatment of Alzheimer's Disease in patients~     who are not taking Aricept, Reminyl, Exelon.~   "
269113|NCT00025272|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving them in different ways may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining topotecan, carboplatin, and~     etoposide in treating patients who have extensive-stage small cell lung cancer.~   "
269114|NCT00025259|"~     This randomized phase III trial is studying different chemotherapy regimens given with or~     without radiation therapy to compare how well they work in treating children with newly~     diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer~     cells from dividing so they stop growing or die. Giving the drugs in different combinations~     may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells.~     It is not yet known if chemotherapy is more effective with or without additional chemotherapy~     and/or radiation therapy in treating Hodgkin's disease.~   "
269115|NCT00025246|"~     This phase II trial is studying how well imatinib mesylate works in treating patients with~     gastrointestinal stromal tumor that was completely removed during surgery. Imatinib mesylate~     may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth~   "
269116|NCT00025233|"~     This phase II trial is to see if bevacizumab works in treating patients who have persistent~     or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or deliver cancer-killing substances to them.~   "
269117|NCT00025220|"~     Phase II trial to study the effectiveness of thalidomide in treating patients who have~     recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by~     stopping blood flow to the tumor.~   "
269118|NCT00025194|"~     RATIONALE: Drugs used in chemotherapy, such as ixabepilone and estramustine, use different~     ways to stop tumor cells from dividing so they stop growing or die. It is not yet known~     whether BMS-247550 is more effective with or without estramustine in treating prostate~     cancer.~      PURPOSE: This randomized phase I/II trial is studying the best dose of ixabepilone when given~     together with estramustine and to see how well giving ixabepilone together with estramustine~     works compared to ixabepilone alone in treating patients with progressive prostate cancer.~   "
269119|NCT00025181|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Vaccines made from a person's~     cancer cells may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody therapy~     and vaccine therapy in treating patients who have stage III or stage IV melanoma that has~     been removed during surgery.~   "
269120|NCT00025168|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Combining radiation~     therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation~     therapy in treating patients who have locally advanced, unresectable pancreatic cancer.~   "
269121|NCT00025155|"~     Phase II trial to study the effectiveness of ixabepilone in treating patients who have~     recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not~     responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop~     tumor cells from dividing so they stop growing or die.~   "
269122|NCT00025142|"~     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor~     cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining more than one drug with~     gefitinib may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gefitinib and oxaliplatin combined with~     leucovorin and fluorouracil in treating patients who have advanced solid tumors or colorectal~     cancer.~   "
269123|NCT00025129|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have~     advanced solid tumors or lymphomas.~   "
269124|NCT00025103|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may~     allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: This phase II trial is studying how well chemotherapy followed by surgery and~     radiation therapy with or without stem cell transplant work in treating patients with~     relapsed or refractory Wilms' tumor or clear cell sarcoma of the kidney.~   "
269125|NCT00025090|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet~     known if fluorouracil plus radiation therapy is more effective with or without additional~     chemotherapy in treating anal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus~     radiation therapy with or without additional chemotherapy in treating patients who have~     primary anal cancer.~   "
269126|NCT00025077|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving a chemotherapy drug before surgery or radiation therapy may~     shrink the tumor so that it can be removed during surgery or radiation therapy. Peripheral~     stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy~     or radiation therapy and allow doctors to give higher doses of chemotherapy.~      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by~     surgery or radiation therapy and peripheral stem cell transplant work in treating patients~     with recurrent medulloblastoma or primitive neuroectodermal and pineal tumors.~   "
269127|NCT00025064|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Peripheral stem cell transplant may be able to replace immune cells that were destroyed by~     chemotherapy.~      PURPOSE: This phase II trial is studying how well combination chemotherapy regimens with or~     without radiation therapy or peripheral stem cell transplant works in treating children with~     Hodgkin's lymphoma.~   "
269128|NCT00025051|"~     RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused~     by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not yet~     known whether celecoxib is more effective than a placebo in preventing skin cancer.~      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing skin~     cancer in participants exposed to ultraviolet light.~   "
269129|NCT00025038|"~     Giving chemotherapy drugs, such as R115777, isotretinoin, cytarabine, and fludarabine, before~     a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of~     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem~     cells. When the healthy stem cells from a donor are infused into the patient they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     This phase II trial is studying how well giving combination chemotherapy together with donor~     bone marrow or umbilical cord blood transplant works in treating children with newly~     diagnosed juvenile myelomonocytic leukemia~   "
269130|NCT00025025|"~     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective~     treatment for colorectal cancer.~      PURPOSE: Randomized screening trial to compare the effectiveness of fecal occult blood~     testing with that of DNA-based testing of stool and blood in identifying colorectal cancer.~   "
269131|NCT00024466|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Vaccines made from a person's cancer cells may make the body~     build an immune response to kill cancer cells. Peripheral stem cell transplantation may be~     able to replace immune cells that were destroyed by chemotherapy. Combining chemotherapy with~     vaccine therapy and peripheral stem cell transplantation may be effective in treating~     multiple myeloma.~      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by vaccine~     therapy and peripheral stem cell transplantation in treating patients who have newly~     diagnosed multiple myeloma.~   "
269132|NCT00024453|"~     RATIONALE: Giving the antibiotic teicoplanin by infusion and allowing bacteria to be exposed~     to the antibiotic for a longer period of time may be effective in preventing or controlling~     septicemia.~      PURPOSE: Randomized clinical trial to compare two different methods of giving teicoplanin in~     treating septicemia in patients who are receiving chemotherapy through a central venous~     catheter.~   "
269133|NCT00024440|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Oblimersen may help fludarabine and cyclophosphamide kill more~     cancer cells by making them more sensitive to the drugs. It is not yet known if fludarabine~     and cyclophosphamide are more effective with or without oblimersen.~      PURPOSE: Randomized phase III trial to compare the effectiveness of fludarabine and~     cyclophosphamide with or without oblimersen in treating patients who have relapsed or~     refractory chronic lymphocytic leukemia.~   "
269134|NCT00024427|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving the drugs in different combinations may kill more tumor~     cells. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side~     effects of chemotherapy. It is not yet known which chemotherapy regimen is more effective in~     treating pancreatic cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus~     triacetyluridine with that of gemcitabine in treating patients who have locally advanced or~     metastatic pancreatic cancer that cannot be treated with surgery.~   "
269135|NCT00024414|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who~     have metastatic prostate cancer that has not responded to hormone therapy.~   "
269136|NCT00024375|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who~     have metastatic pancreatic cancer.~   "
269137|NCT00024349|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy such as fluorouracil and mitomycin use different ways to stop tumor cells from~     dividing so they stop growing or die. Fluorouracil and mitomycin may make the tumor cells~     more sensitive to radiation therapy. It is not yet known if radiation therapy is more~     effective with or without chemotherapy in treating bladder cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to all~     or part of the bladder with or without chemotherapy in treating patients who have stage II or~     stage III bladder cancer.~   "
269138|NCT00024336|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Tamoxifen may~     kill tumor cells by blocking the enzymes necessary for cell growth. Combining radiation~     therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma.~      PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy and~     tamoxifen in treating children who have newly diagnosed brain stem glioma.~   "
269139|NCT00024297|"~     RATIONALE: Warfarin may be effective in preventing the formation of blood clots in patients~     with central venous catheters.~      PURPOSE: Randomized clinical trial to study the effectiveness of warfarin in preventing blood~     clots in cancer patients who have central venous catheters.~   "
269140|NCT00024284|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in~     treating children who have refractory solid tumors.~   "
269141|NCT00024271|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving the drugs directly into the tumor after surgery and~     combining them with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy, and~     radiation therapy in treating patients who have peritoneal cancer.~   "
269142|NCT00024258|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children~     who have advanced neuroblastoma or other solid tumors.~   "
270124|NCT00051896|"~     The purpose of this study is to assess the potential interactions between iv cocaine and GBR~     12909.~   "
269143|NCT00024245|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Probenecid may increase the effectiveness of~     10-propargyl-10-deazaaminopterin by making tumor cells more sensitive to the drug.~      PURPOSE: Phase I trial to study the effectiveness of combining~     10-propargyl-10-deazaaminopterin and probenecid in treating patients who have advanced solid~     tumors.~   "
269144|NCT00024232|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have prostate cancer that has not responded to hormone therapy.~   "
269145|NCT00024193|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give~     higher doses of chemotherapy drugs to kill more tumor cells. Chemotherapy, given before and~     after surgery, followed by peripheral stem cell transplantation may be an effective treatment~     for metastatic neuroblastoma.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, given before and after~     surgery, followed by peripheral stem cell transplantation in treating patients who have~     metastatic neuroblastoma.~   "
269146|NCT00024180|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have~     hematologic cancer.~   "
269147|NCT00024167|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radioactive substances such as strontium-89 may relieve bone pain~     associated with prostate cancer. It is not yet known whether chemotherapy is more effective~     with or without strontium-89 in treating bone metastases.~      PURPOSE: This randomized phase III trial is studying giving chemotherapy together with~     strontium-89 to see how well it works compared to chemotherapy alone in treating patients~     with prostate cancer that has spread to the bone.~   "
269148|NCT00024154|"~     This phase II trial is studying how well giving trastuzumab together with gefitinib works in~     treating patients with HER2-positive breast cancer. The monoclonal antibody trastuzumab can~     locate breast cancer cells that have HER2 on their surface and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Biological therapies such as~     gefitinib may also interfere with the growth of tumor cells and may enhance the effects of~     trastuzumab. Combining trastuzumab with gefitinib may be an effective treatment for~     metastatic breast cancers with high amounts of HER2~   "
269149|NCT00024115|"~     RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal~     cells.~      PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating~     patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.~   "
269150|NCT00024102|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving them in different ways~     after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is~     more effective in treating older women with breast cancer.~      PURPOSE: This randomized phase III trial is studying different combination chemotherapy~     regimens to see how well they work in treating older women who have undergone surgery for~     breast cancer.~   "
269151|NCT00024089|"~     Phase II trial to study the effectiveness of gefitinib in treating patients who have~     recurrent and/or metastatic head and neck cancer. Biological therapies such as gefitinib may~     interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth.~   "
269152|NCT00024076|"~     RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells.~     CT-guided radiofrequency ablation may be effective treatment for lung cancer.~      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating~     patients who have refractory or advanced lung cancer.~   "
269153|NCT00024050|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may be able to replace~     immune cells that were destroyed by chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral~     stem cell transplantation in treating patients who have myelodysplastic syndrome.~   "
269154|NCT00023998|"~     Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they~     stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and~     kill them without harming normal cells. Combining monoclonal antibody therapy with~     chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of~     chemotherapy with or without trastuzumab in treating patients who have metastatic~     osteosarcoma~   "
269155|NCT00023985|"~     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body~     build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have non-small cell lung cancer.~   "
269156|NCT00023972|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if gemcitabine is more effective with or~     without exatecan mesylate in treating pancreatic cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that~     of gemcitabine and exatecan mesylate in treating patients who have locally advanced or~     metastatic pancreatic cancer.~   "
269157|NCT00023959|"~     Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some~     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill~     them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in~     different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy~     with chemotherapy and radiation therapy may be an effective treatment for head and neck~     cancer. This phase I trial is to see if combining bevacizumab, fluorouracil, and hydroxyurea~     with radiation therapy works in treating patients who have advanced head and neck cancer~   "
269158|NCT00023946|"~     Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver~     or gallbladder cancer. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die.~   "
269159|NCT00023920|"~     This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works~     better in treating patients who have blast phase chronic myelogenous leukemia. Monoclonal~     antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     deliver cancer-killing substances to them. Drugs used in chemotherapy, such as idarubicin and~     cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment~     for blast phase chronic myelogenous leukemia~   "
269160|NCT00023894|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who~     have recurrent or persistent endometrial cancer.~   "
269161|NCT00023881|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who~     have chronic myelogenous leukemia in chronic or accelerated phase.~   "
269162|NCT00023855|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of combining PS-341 and doxorubicin in~     treating patients who have advanced solid tumors.~   "
269163|NCT00023842|"~     RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system~     and stop tumor cells from growing. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining chemotherapy with biological~     therapy may kill more tumor cells. It is not yet known if BCG is more effective with or~     without mitomycin.~      PURPOSE: Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with~     that of BCG alone in treating patients who have bladder cancer.~   "
269164|NCT00023829|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can~     stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may~     stop the adrenal glands from producing androgens. Giving radiation therapy with hormone~     therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery~     and be an effective treatment for stage II or stage III prostate cancer. It is not yet known~     if radiation therapy combined with hormone therapy is more effective than either radiation~     therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer.~     (Hormone therapy alone group closed as of 12/9/2002.)~      PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant radiation~     therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in~     treating patients who have stage II or stage III prostate cancer.~   "
269165|NCT00023790|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill tumor cells. This may be effective treatment for skin cancer and cancer that is~     metastatic to the skin.~      PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating~     patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors~     metastatic to the skin.~   "
269166|NCT00023777|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and daunorubicin~     in treating older patients who have acute myeloid leukemia that has not been previously~     treated.~   "
269167|NCT00023764|"~     Phase II trial to study the effectiveness of bortezomib in treating patients who have~     low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by~     blocking the enzymes necessary for cancer cell growth.~   "
269168|NCT00023751|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining surgery with chemotherapy and radiation therapy may kill more tumor cells and~     prevent recurrence of the cancer.~      PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy~     and radiation therapy in treating patients who have stage I rectal cancer.~   "
269169|NCT00023712|"~     Phase II trial to study the effectiveness of bortezomib in treating patients who have~     persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Bortezomib~     may stop the growth of cancer cells by blocking the enzymes necessary for their growth.~   "
269170|NCT00023686|"~     RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor~     to kill tumor cells. It is not yet known whether surgery is more effective than internal~     radiation in treating prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of~     internal radiation in treating patients who have stage II prostate cancer.~   "
269171|NCT00023660|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Giving radiation therapy in different ways and combining it with chemotherapy may kill~     more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to~     the tumor.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib,~     fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.~   "
269172|NCT00023634|"~     RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill~     cancer cells.~      PURPOSE: This phase I trial is studying two different vaccines to treat patients who have~     gastric, prostate, or ovarian cancer.~   "
269173|NCT00023621|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. The use of celecoxib may be an effective way to prevent the~     development of basal cell carcinoma.~      PURPOSE: Randomized phase II trial to determine the effectiveness of celecoxib in preventing~     basal cell carcinoma in patients who have basal cell nevus syndrome.~   "
269210|NCT00021320|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or~     without radiation therapy in treating patients who have esophageal cancer.~   "
269174|NCT00022737|"~     This phase II trial is studying how well combination chemotherapy with or without donor~     peripheral stem cell transplant works in treating children with acute lymphoblastic leukemia.~     Giving combination chemotherapy before a donor peripheral stem cell transplant helps stop the~     growth of cancer cells. It also helps stop the patient's immune system from rejecting the~     donor's stem cells. When the healthy stem cells from a donor are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets.~   "
269175|NCT00022724|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have~     malignant glioma.~   "
269176|NCT00022711|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have relapsed or progressive small cell lung cancer.~   "
269177|NCT00022698|"~     PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan~     in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.~   "
269178|NCT00022685|"~     RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase III trial to determine the effectiveness of epratuzumab in treating patients~     who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or~     rituximab.~   "
269179|NCT00022672|"~     This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab~     (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line~     treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2)~     overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to~     receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading~     dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg~     iv. The anticipated time on study treatment was until disease progression, and the target~     sample size was 100-500 individuals.~   "
269180|NCT00022659|"~     This phase II trial is to see if bevacizumab works in treating patients who have persistent~     or recurrent ovarian epithelial cancer or primary peritoneal cancer. Monoclonal antibodies,~     such as bevacizumab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or deliver~     cancer-killing substances to them.~   "
269181|NCT00022646|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving more than one drug and giving the drugs in different ways~     may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens~     of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or~     metastatic non-small cell lung cancer.~   "
269182|NCT00022633|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in~     treating patients who have advanced or recurrent cancer of the urinary tract.~   "
269183|NCT00022620|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who~     have refractory or recurrent endometrial cancer.~   "
269184|NCT00022607|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or deliver cancer-killing substances to them. Thalidomide may stop the growth~     of cancer cells by stopping blood flow to the tumor. It is not yet known whether bevacizumab~     works better with or without thalidomide for multiple myeloma.~      PURPOSE: This randomized phase II trial is to see if bevacizumab works better with or without~     thalidomide in treating patients who have relapsed or refractory multiple myeloma.~   "
269185|NCT00022581|"~     Phase II trial to study the effectiveness of thalidomide in treating patients who have~     relapsed or refractory low-grade non-Hodgkin's lymphoma. Thalidomide may stop the growth of~     non-Hodgkin's lymphoma by stopping blood flow to the tumor~   "
269186|NCT00022568|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have metastatic melanoma.~   "
269187|NCT00022555|"~     Phase I trial to study the effectiveness of bryostatin 1 plus vincristine in treating~     patients who have recurrent or refractory lymphoma. Drugs used in chemotherapy use different~     ways to stop cancer cells from dividing so they stop growing or die. Bryostatin 1 may help~     vincristine kill more cancer cells by making them more sensitive to the drug~   "
269188|NCT00022516|"~     This randomized, phase III trial was designed to test the efficacy of a low-dose~     chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered~     following standard chemotherapy in patients with early breast cancer whose tumors are hormone~     receptor negative.~   "
269189|NCT00022490|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by~     blocking the enzymes necessary for cancer cell growth.~      PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to~     see how well it works in treating patients with chronic phase chronic myelogenous leukemia.~   "
269190|NCT00022464|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have~     metastatic melanoma.~   "
269191|NCT00022451|"~     RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary~     for cancer cell growth.~      PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating young patients~     who have refractory leukemia.~   "
269538|NCT00006078|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. The use of lycopene may be an effective way to prevent prostate~     cancer.~      PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.~   "
269192|NCT00022438|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining~     vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.~      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus~     interleukin-2 to that of vaccine therapy alone in treating patients who have metastatic~     melanoma that has not responded to previous treatment.~   "
269193|NCT00022425|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     recurrence of cancer. The use of perillyl alcohol may be effective in preventing the~     recurrence of breast cancer.~      PURPOSE: Phase I trial to study the effectiveness of perillyl alcohol in preventing the~     recurrence of breast cancer in women who have been treated with surgery with or without~     adjuvant therapy.~   "
269194|NCT00022412|"~     RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before~     surgery.~      PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol~     before surgery in treating patients who have localized prostate cancer.~   "
269195|NCT00022399|"~     RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not~     yet known if celecoxib is more effective than no treatment before surgery for prostate~     cancer.~      PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before~     surgery to remove the prostate in treating patients who have localized prostate cancer.~   "
269196|NCT00022334|"~     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make~     the body build an immune response to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     who have liver cancer.~   "
269197|NCT00022295|"~     RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary~     for cancer cell growth.~      PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who~     have refractory solid tumors.~   "
269198|NCT00022230|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies use different ways to stimulate the immune~     system and stop tumor cells from growing. Combining chemotherapy with biological therapy may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects of giving chemotherapy together~     with biological therapy and to see how well they work in treating patients with stage II or~     stage III breast cancer.~   "
269199|NCT00022191|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which combination chemotherapy regimen is more~     effective for urinary tract cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus~     gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract~     cancer.~   "
269200|NCT00022152|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who~     have stage IV breast cancer.~   "
269201|NCT00022126|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Giving the drugs in different combinations may kill more cancer~     cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and~     kill more cancer cells.~      PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or~     without donor bone marrow transplantation in treating infants who have previously untreated~     acute lymphoblastic leukemia.~   "
269202|NCT00022113|"~     Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced~     solid tumors. EMD 121974 may slow the growth of solid tumors by stopping blood flow to the~     tumor~   "
269203|NCT00022087|"~     RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving~     adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective~     in preventing bone loss.~      PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus~     calcium and vitamin D to see how well they work in preventing bone loss in women who are~     receiving adjuvant chemotherapy for breast cancer.~   "
269204|NCT00022074|"~     RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if~     gabapentin is effective in treating hot flashes.~      PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling~     hot flashes in women who have breast cancer.~   "
269205|NCT00022048|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and~     help kill them or deliver cancer-killing substances to them.~      PURPOSE: This phase I/II trial is to see if bevacizumab works in treating patients who have~     myelodysplastic syndrome.~   "
269206|NCT00022035|"~     RATIONALE: Flu vaccine may help the body build an immune response and decrease the occurrence~     of flu in children who are receiving chemotherapy for acute lymphoblastic leukemia.~      PURPOSE: Clinical trial to study the effectiveness of vaccine therapy in preventing flu in~     children who have acute lymphoblastic leukemia.~   "
269207|NCT00022022|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which chemotherapy regimen is more effective in~     treating non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating~     patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
269208|NCT00021450|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and~     goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet~     known if radiation therapy is more effective with or without bicalutamide and goserelin in~     treating prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without bicalutamide and goserelin in treating patients who have localized prostate cancer.~   "
269209|NCT00021424|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have stage IV head and neck cancer.~   "
270125|NCT00051883|"~     The purpose of this study is to asses patient views on smoking cessation and tobacco harm~     reduction during drug treatment.~   "
269211|NCT00021255|"~     Primary objective:~        -  Compare disease-free survival in women with human epidermal growth factor receptor 2~          (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer~          treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without~          trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.~      Secondary objective:~        -  Compare overall survival of participants treated with these regimens.~        -  Compare the toxic effects (including cardiac) of these regimens in these participants.~        -  Compare quality of life of participants treated with these regimens.~        -  Compare pathologic and molecular markers for predicting efficacy of these regimens in~          these participants.~        -  For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with~          fluorescence in situ hybridization in predicting outcome in participants treated with~          these regimens.~   "
269212|NCT00021242|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     cancer cells from dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have~     relapsed or refractory acute lymphoblastic or acute myeloid leukemia.~   "
269213|NCT00021229|"~     Phase I/II trial to estimate the maximum tolerated dose of imatinib mesylate in newly~     diagnosed brain stem gliomas and recurrent high grade gliomas and to assess the effectiveness~     of imatinib mesylate in treating young patients who have newly diagnosed intrinsic brain stem~     glioma. Imatinib mesylate may interfere with the growth of tumor cells by blocking the~     enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor~     cells. Combining imatinib mesylate with radiation therapy may kill more tumor cells.~   "
269214|NCT00021216|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Phase I trial to study the effectiveness of bortezomib in treating children~     who have advanced solid tumors that have not responded to previous treatment.~   "
269215|NCT00021164|"~     RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill~     tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating~     patients who have metastatic cancer.~   "
269216|NCT00021125|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known which regimen of radiation therapy is more effective for head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     radiation therapy in treating patients who have head and neck cancer.~   "
269217|NCT00021112|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation~     therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.~   "
269218|NCT00021073|"~     Phase I trial to study the effectiveness of combining flavopiridol, fluorouracil, and~     leucovorin with or without irinotecan in treating patients who have advanced cancer. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug may kill more tumor cells.~   "
269219|NCT00021060|"~     Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they~     stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer~     cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy~     with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is~     to see if combination chemotherapy works better with or without bevacizumab in treating~     patients who have advanced, metastatic, or recurrent non-small cell lung cance~   "
269220|NCT00021047|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin, carboplatin,~     and capecitabine in treating patients who have unresectable locally advanced, metastatic, or~     recurrent solid tumor.~   "
269221|NCT00020995|"~     RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet~     with that of a standard diet in treating patients who have prostate cancer.~   "
269222|NCT00020969|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have myelodysplastic syndromes.~   "
269223|NCT00020943|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells.~     Peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab~     with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.~   "
269224|NCT00020891|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Multiple CT scans~     may improve the accuracy of radiation therapy for prostate cancer.~      PURPOSE: Phase I trial to study the effectiveness of multiple CT scans in guiding the~     treatment of patients who have prostate cancer and are undergoing radiation therapy.~   "
269225|NCT00020878|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco~     smokers.~      PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell~     lung cancer in tobacco smokers.~   "
269226|NCT00020852|"~     RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by~     lumpectomy or mastectomy may be an effective treatment for breast lesions.~      PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have~     breast lesions.~   "
270944|NCT00040547|"~     The purpose of this study is to determine the safety and tolerability of an oral Farnesyl~     Protein Transferase Inhibitor (SCH 66336) when given in combination with intravenous~     docetaxel in cancer patients with advanced solid tumors.~   "
269227|NCT00020839|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not yet known if chemotherapy is more effective with or without radiation therapy in~     treating brain metastases.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or~     without radiation therapy to the brain in treating patients who have stage IV melanoma with~     asymptomatic brain metastases.~   "
269228|NCT00020826|"~     RATIONALE: Assessing quality of life in patients who are undergoing cancer treatment may help~     determine the effect of treatment on these patients.~      PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in~     patients who are receiving treatment for stomach cancer.~   "
269229|NCT00020800|"~     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different way to stop cancer cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating~     patients who have Waldenstrom's macroglobulinemia.~   "
269230|NCT00020761|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and paclitaxel in~     treating patients who have metastatic or recurrent cancer of the esophagus or stomach.~   "
269231|NCT00020748|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of epirubicin plus irinotecan in treating~     patients who have advanced cancer.~   "
269232|NCT00020735|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using~     toremifene may fight prostate cancer by reducing the production of androgens.~      PURPOSE: Randomized phase II trial to study the effectiveness of toremifene followed by~     radical prostatectomy in treating patients who have stage I or stage II prostate cancer.~   "
269233|NCT00020722|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     plus biological therapy may allow the doctor to give higher doses of chemotherapy drugs and~     kill more tumor cells.~      PURPOSE: This phase II trial is studying how well chemotherapy followed by peripheral stem~     cell transplantation plus biological therapy works in treating women with stage IV breast~     cancer.~   "
269234|NCT00020709|"~     Randomized phase III trial to compare the effectiveness of combination chemotherapy plus~     radiation therapy with or without gefitinib in treating unresectable stage III non-small cell~     lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Biological therapies such as gefitinib may interfere with the growth of the tumor cells and~     slow the growth of tumors. It is not yet known whether combination chemotherapy plus~     radiation therapy is more effective with or without gefitinib in treating non-small cell lung~     cancer~   "
269235|NCT00020683|"~     COL-3 may stop the growth of cancer by stopping blood flow to the tumor. Randomized phase II~     trial to compare the effectiveness of two different regimens of COL-3 in treating patients~     who have HIV-related Kaposi's sarcoma.~   "
269236|NCT00020670|"~     The prognosis for children and adults with acute lymphoblastic leukemia (ALL) has improved~     significantly over the years. Nevertheless, patients who experience disease relapse or~     induction failure along with patients having unfavorable genetics [t(4;11) or t(9;22)] have~     dismal prognosis. For these patients, novel therapeutic approaches such as immunotherapy are~     needed. In this clinical trial, investigators evaluate whether it is feasible to make a~     vaccine from leukemia cells and whether this vaccine enables direct immunity against cancer~     cells in patients.~   "
269237|NCT00020657|"~     RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients~     being treated with chemotherapy.~      PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs~     work in preventing delayed nausea after chemotherapy in patients who have cancer.~   "
269238|NCT00020644|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of gemcitabine given as a continuous~     infusion in treating patients who have advanced metastatic cancer.~   "
269239|NCT00020631|"~     RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.~      PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening~     fibrosis in patients who have undergone radiation therapy for cancer.~   "
269240|NCT00020579|"~     RATIONALE: MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for~     their growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 in treating~     patients with advanced solid tumors or lymphoma.~   "
269241|NCT00020566|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is~     more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.~      PURPOSE: This randomized phase III trial is studying different combination chemotherapy~     regimens to see how well they work when given with or without peripheral stem cell~     transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.~   "
269242|NCT00020527|"~     RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and~     neutropenia caused by chemotherapy or bone marrow transplantation.~      PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating~     children who have fever and neutropenia caused by a weakened immune system.~   "
269375|NCT00014079|"~     RATIONALE: Determination of genetic markers for colorectal cancer may improve the~     identification of patients who are at highest risk for relapse.~      PURPOSE: This clinical trial is studying the importance of genetic markers for detecting~     relapse in patients with colorectal cancer.~   "
269243|NCT00020501|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving them in different ways may~     kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for~     colorectal cancer that has spread to the liver.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without isolated hepatic perfusion with melphalan in treating patients who have~     colorectal cancer that has spread to the liver.~   "
269244|NCT00020488|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced solid tumors.~   "
269245|NCT00020449|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood~     flow to the tumor and by stimulating a person's white blood cells to kill the tumor cells.~     Combining chemotherapy with interleukin-12 may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with~     interleukin-12 in treating patients who have AIDS-related Kaposi's sarcoma.~   "
269246|NCT00020410|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell~     transplantation may allow the doctor to give higher doses of monoclonal antibody therapy and~     kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody~     followed by peripheral stem cell transplantation in treating patients who have relapsed or~     metastatic breast cancer.~   "
269247|NCT00020397|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating~     patients who have refractory metastatic melanoma.~   "
269248|NCT00020358|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine~     therapy may be an effective treatment for melanoma.~      PURPOSE: Randomized phase II trial to study the effectiveness of three vaccine therapy~     regimens in treating patients who have melanoma.~   "
269249|NCT00020332|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating~     patients who have locally advanced or metastatic breast cancer.~   "
269250|NCT00020254|"~     RATIONALE: Vaccines made from prostate cancer cells may make the body build an immune~     response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase~     the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may~     stimulate a person's white blood cells to kill prostate cancer cells. Androgens can stimulate~     the growth of prostate cancer cells. Hormone therapy using nilutamide may fight prostate~     cancer by reducing the production of androgens. It is not yet known which treatment regimen~     is more effective for treating prostate cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus~     sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have~     prostate cancer that has not responded to hormone therapy.~   "
269251|NCT00020189|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who~     have recurrent or metastatic head and neck cancer.~   "
269252|NCT00020176|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy used to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell~     transplantation in treating patients who have stage IV breast cancer.~   "
269253|NCT00020150|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and~     O6-benzylguanine in treating children who have solid tumors that have not responded to~     previous therapy.~   "
269254|NCT00020124|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs in different ways may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients~     who have advanced solid tumors affecting the lungs.~   "
269255|NCT00020111|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in~     treating young patients with leukemia or lymphoma.~   "
269256|NCT00020072|"~     RATIONALE: Analyzing genes that are present in cancer cells may be useful in developing~     better methods to detect, predict, and treat cutaneous T-cell lymphoma.~      PURPOSE: Clinical trial to study genes that are present in cutaneous T-cell lymphoma cells.~   "
269257|NCT00020007|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Heating paclitaxel to several degrees above body temperature and~     infusing it to the affected area around the tumor may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel given by~     hyperthermic perfusion in treating patients with lung cancer or lung metastases that cannot~     be removed by surgery.~   "
269258|NCT00019994|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients~     who have metastatic melanoma that has not responded to previous therapy.~   "
269259|NCT00019955|"~     RATIONALE: Radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors~     to several degrees above body temperature.~      PURPOSE: This phase II trial is studying radiofrequency interstitial tissue ablation to see~     how well it works in treating patients with localized renal cell carcinoma (kidney cancer).~   "
269260|NCT00019929|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see~     how well it works in treating patients with stage III non-small cell lung cancer.~   "
269261|NCT00019916|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. It is not yet~     known whether combining vaccine therapy with interleukin-2 is effective in treating breast~     and ovarian cancer.~      PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and~     interleukin-2 and to see how well they work in treating women with stage IV, recurrent, or~     progressive breast or ovarian cancer.~   "
269262|NCT00019864|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it~     can be removed during surgery. Giving chemotherapy after surgery may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving chemotherapy before and after~     surgery works in treating patients with osteosarcoma.~   "
269263|NCT00019838|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when~     given with UCN-01 in treating patients with recurrent or refractory low-grade lymphoma or~     leukemia.~   "
269264|NCT00019825|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients who have~     unresectable lung or esophageal cancer or malignant mesothelioma of the pleura.~   "
269265|NCT00019812|"~     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver~     tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use~     different ways to make tumor cells stop dividing so they stop growing or die. Combining~     monoclonal antibody therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating~     patients who have metastatic breast cancer that overexpresses HER2.~   "
269266|NCT00019786|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs in different ways may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan~     works in treating patients with primary unresectable liver cancer or liver metastases.~   "
269267|NCT00019773|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with capecitabine~     in treating patients who have colorectal, appendix, or small bowel cancer.~   "
269268|NCT00019747|"~     RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the~     tumor. Giving thalidomide after surgery may kill any remaining tumor cells.~      PURPOSE: This randomized phase II trial is studying surgery and thalidomide to see how well~     they work compared to surgery alone in treating patients with recurrent or metastatic~     colorectal cancer.~   "
269269|NCT00019708|"~     Phase I trial to study the effectiveness of geldanamycin analogue in treating patients who~     have advanced solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy work in~     different ways to stop tumor cells from dividing so they stop growing or die.~   "
269270|NCT00019682|"~     This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it~     works compared to aldesleukin alone in treating patients with melanoma that has spread from~     where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin~     may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body~     build an immune response to kill tumor cells. It is not yet known whether combining~     aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating~     melanoma.~   "
269271|NCT00019669|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not~     yet known whether combining melanoma vaccine with interleukin-2 is more effective than~     vaccine therapy alone in treating metastatic melanoma.~      PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2~     with that of melanoma vaccine alone in treating patients who have metastatic melanoma that~     has not responded to previous treatment.~   "
269272|NCT00019656|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have~     refractory solid tumors or hematologic cancer.~   "
269273|NCT00019604|"~     RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above~     body temperature and may kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating~     patients who have unresectable primary or metastatic liver cancer.~   "
269274|NCT00019591|"~     RATIONALE: Vaccines may make the body build an immune response that will kill cancer cells.~     Combining vaccine therapy with interleukin-2 may kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without~     interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer.~   "
269275|NCT00019565|"~     RATIONALE: Diagnostic procedures, such as PET and MRI scans, may help to measure a patient's~     response to treatment.~      PURPOSE: This diagnostic trial is studying how well PET and/or MRI scans work in assessing~     changes in tumor blood supply in patients receiving antiangiogenesis therapy.~   "
269276|NCT00019513|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil, and~     leucovorin in treating patients with recurrent, refractory, or metastatic solid tumors or~     lymphomas.~   "
269277|NCT00019487|"~     RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune~     response and kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients~     who have metastatic melanoma that has not responded to previous therapy.~   "
269278|NCT00019461|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating~     patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary~     peritoneal cancer.~   "
269279|NCT00019422|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Lobradimil may increase the effectiveness of a chemotherapy drug by~     making tumor cells more sensitive to the drug.~      PURPOSE: Phase II trial to study the effectiveness of carboplatin and lobradimil in treating~     children with brain tumors that have not responded to previous treatment.~   "
269280|NCT00019331|"~     RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill~     tumor cells. Combining vaccine therapy with interleukin-2 and/or sargramostim may be a more~     effective treatment for solid tumors.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2~     and/or sargramostim in treating adults who have metastatic solid tumors.~   "
269281|NCT00019227|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus~     pentetic acid calcium in patients with leukemia.~   "
269282|NCT00019214|"~     RATIONALE: Vaccines made from white blood cells treated with antigens may make the body build~     an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood~     cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more~     melanoma cells.~      PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine~     therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with~     metastatic melanoma that has not responded to previous therapy.~   "
269283|NCT00019201|"~     RATIONALE: Fluorescent bronchoscopy, when used in combination with conventional white light~     bronchoscopy, may improve the ability to detect early lung cancer.~      PURPOSE: A pilot study to evaluate fluorescent light bronchoscopy plus conventional~     bronchoscopy as a tool for screening and detecting lung cancer in persons with completely~     resected head and neck cancer or successfully treated early-stage lung cancer.~   "
269284|NCT00019136|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill ovarian cancer~     cells. Interleukin-2 combined with white blood cells that are gene-modified to recognize and~     kill ovarian cancer cells may be an effective treatment for recurrent or residual ovarian~     cancer.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 plus gene-modified white~     blood cells in treating patients who have advanced ovarian epithelial cancer.~   "
269285|NCT00019110|"~     RATIONALE: Vaccines made from certain human papillomaviruses may be able to help the body to~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of human papillomavirus vaccine therapy in~     treating patients who have advanced or recurrent cancer of the cervix, vagina, penis, anus,~     esophagus, or head and neck.~   "
269286|NCT00019032|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have chronic lymphocytic leukemia.~   "
269287|NCT00019019|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or~     refractory lymphomas.~   "
269288|NCT00018967|"~     RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from~     the toxic effects of chemotherapy.~      PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous~     system toxic effects in patients given an accidental overdose of intrathecal methotrexate.~   "
269289|NCT00017602|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Oblimersen may increase the effectiveness of dexamethasone by~     making cancer cells more sensitive to the drug. It is not yet known if dexamethasone is more~     effective with or without oblimersen in treating multiple myeloma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with or~     without oblimersen in treating patients who have relapsed or refractory multiple myeloma.~   "
269290|NCT00017589|"~     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and~     either kill them or deliver tumor-killing substances to them without harming normal cells.~     Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more~     sensitive to the drug.~      PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab~     ozogamicin in treating older patients who have relapsed acute myeloid leukemia.~   "
269291|NCT00017563|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving chemotherapy before surgery~     may shrink the tumor so that it can be removed during surgery.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by~     surgery in treating patients who have localized prostate cancer.~   "
269292|NCT00017550|"~     RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be~     effective treatment for myelodysplastic syndrome. It is not yet known whether~     immunosuppressive therapy is more effective than supportive care in treating myelodysplastic~     syndrome.~      PURPOSE: Randomized phase II trial to compare the effectiveness of antithymocyte globulin~     with that of supportive care in treating patients who have myelodysplastic syndrome.~   "
269293|NCT00017524|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of AG2037 in treating patients who have~     advanced, metastatic, or recurrent solid tumors.~   "
269294|NCT00017511|"~     RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation~     therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no~     therapy in treating dry mouth caused by radiation therapy.~      PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating~     patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.~   "
269295|NCT00017498|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who~     have recurrent or metastatic adenoid cystic cancer of the head and neck.~   "
269296|NCT00017485|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer cells~     and, when exposed to light, become active and kill the cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in~     treating patients who have basal cell skin cancer.~   "
269297|NCT00017472|"~     Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing~     substances to them without harming normal cells. Phase I trial to study the effectiveness of~     monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia,~     lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.~   "
269298|NCT00017381|"~     This phase I trial is studying how well monoclonal antibody therapy with peripheral stem cell~     transplant works in treating patients with non-Hodgkin's lymphoma. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Peripheral stem cell transplant may allow the doctor to~     give higher doses of monoclonal antibodies and kill more cancer cells~   "
269299|NCT00017355|"~     RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may~     make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who~     have metastatic melanoma.~   "
269300|NCT00017329|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have~     metastatic kidney cancer.~   "
269301|NCT00017290|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Vaccines may make the body build an immune response to kill~     cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy~     is more effective for non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to determine the effectiveness of combination~     chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have~     stage III or stage IV non-Hodgkin's lymphoma.~   "
269302|NCT00017277|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may~     help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is~     more effective with or without epoetin alfa in treating head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without epoetin alfa in treating patients who have head and neck cancer.~   "
269303|NCT00017264|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of atrasentan in treating patients who have~     progressive or recurrent malignant glioma.~   "
269304|NCT00017251|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I~     trial to study the effectiveness of combination chemotherapy and oblimersen in treating~     patients who have extensive-stage small cell lung cancer~   "
269305|NCT00017238|"~     Phase I trial to study the effectiveness of KRN5500 in treating patients who have solid~     tumors. Drugs used in chemotherapy, such as KRN5500, work in different ways to stop cancer~     cells from dividing so they stop growing or die~   "
269306|NCT00017225|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Peripheral stem cell transplantation may be able to replace immune cells that were destroyed~     by chemotherapy or radiation therapy used to kill tumor cells. Combining these therapies may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation~     therapy with or without peripheral stem cell transplantation in treating patients who have~     neuroblastoma.~   "
269307|NCT00017212|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients~     who have metastatic stomach cancer.~   "
269308|NCT00017186|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in~     treating patients who have malignant mesothelioma.~   "
269309|NCT00017173|"~     RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability~     to fight cancer. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Combining chemotherapy and radiation therapy with the p53 gene may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gene therapy plus surgery followed by~     cisplatin and radiation therapy in treating patients who have newly diagnosed resectable~     stage III or stage IV cancer of the mouth or throat.~   "
269310|NCT00017160|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation~     therapy, and surgery in treating patients who have primary or recurrent sarcoma.~   "
269311|NCT00017147|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more~     sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more~     effective with or without O6-benzylguanine.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus~     carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed~     glioblastoma multiforme or gliosarcoma.~   "
270126|NCT00051844|"~     This is a 48 week study that is intended for HIV Infected persons whose first treatment~     regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now~     failing that regimen. They must be currently on their failing regimen to be eligible.~   "
269313|NCT00017108|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known which chlorambucil regimen is more effective~     in treating advanced chronic lymphocytic leukemia.~      PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of~     chlorambucil in treating patients who have advanced chronic lymphocytic leukemia.~   "
269314|NCT00017095|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Currently patients with breast cancer are treated with~     one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may~     help doctors predict how well patients with breast cancer will respond to treatment and help~     doctors choose the best drug regimen to treat each patient.~      PURPOSE: This randomized phase III trial is studying giving different regimens of~     chemotherapy and comparing how well they work in treating women with large operable or~     locally advanced or inflammatory breast cancer. This study is also looking at whether~     analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well~     patients will respond to treatment and help doctors choose the best drug to treat each~     patient.~   "
269315|NCT00017069|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and~     dexamethasone in treating patients who have recurrent or refractory stage II or stage III~     multiple myeloma.~   "
269316|NCT00017004|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa~     may stimulate red blood cell production to treat anemia in patients who have received~     chemotherapy and/or radiation therapy for cervical cancer. Randomized phase III trial to~     study the effectiveness of epoetin alfa in treating anemia in patients who have cervical~     cancer.~   "
269317|NCT00016991|"~     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells~     and slow the growth of glioblastoma multiforme.~      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have~     glioblastoma multiforme in first relapse.~   "
269318|NCT00016965|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who~     have advanced pancreatic cancer.~   "
269319|NCT00016952|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving the drugs in different combinations may kill more tumor~     cells.~      PURPOSE: Phase II trial to compare the effectiveness of either irinotecan or fluorouracil~     plus leucovorin in treating patients who have metastatic colorectal cancer that has been~     previously treated with oxaliplatin with or without irinotecan.~   "
269320|NCT00016926|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who~     have advanced, persistent, or recurrent cervical cancer.~   "
269321|NCT00016913|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs~     such as goserelin or leuprolide may stop the adrenal glands from producing androgens.~     Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy,~     hormone therapy, and radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy~     and radiation therapy in treating patients with locally advanced prostate cancer.~   "
269322|NCT00016887|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill cancer cells. Peripheral stem cell transplant may allow the doctor~     to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may~     interfere with the growth of cancer cells. It is not yet known whether giving more than one~     drug (combination chemotherapy) with radiation therapy and peripheral stem cell transplant is~     more effective than chemotherapy followed by interferon alfa in treating mantle cell~     lymphoma.~      PURPOSE: This randomized phase III trial compares how well chemotherapy followed by radiation~     therapy, chemotherapy, and peripheral stem cell transplant works compared to chemotherapy~     plus interferon alfa in treating patients who have stage III or stage IV mantle cell~     lymphoma.~   "
269323|NCT00016861|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children who have~     refractory or progressive solid tumors.~   "
269324|NCT00016432|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells.~     It is not yet known whether exemestane is effective in preventing the recurrence of breast~     cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing~     cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA~     breast cancer and have completed 5 years of tamoxifen.~   "
269325|NCT00016419|"~     RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an~     effective treatment for myelodysplastic syndrome.~      PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus~     cyclosporine in treating patients who have myelodysplastic syndrome.~   "
269326|NCT00016406|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether combination chemotherapy is more~     effective with or without filgrastim in treating breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combining doxorubicin,~     cyclophosphamide, and paclitaxel with or without filgrastim in treating women who have~     inflammatory or locally advanced breast cancer.~   "
269327|NCT00016393|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who~     have prostate cancer that has not responded to hormone therapy.~   "
269328|NCT00016380|"~     RATIONALE: Antiemetic drugs may help to reduce or prevent vomiting in patients treated with~     radiation therapy. It is not yet known if ondansetron is more effective with or without~     dexamethasone in preventing vomiting caused by radiation therapy.~      PURPOSE: This randomized phase III trial is comparing how well ondansetron works with or~     without dexamethasone in preventing vomiting in patients with cancer who are receiving~     radiation therapy to the upper abdomen.~   "
269329|NCT00016354|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of benzoylphenylurea in treating patients~     who have advanced solid tumors.~   "
269330|NCT00016328|"~     Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent~     glioblastoma multiforme. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die.~   "
269331|NCT00016302|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Combining more than one drug may kill more cancer cells. This phase II trial~     is studying several different combination chemotherapy regimens to see how well they work in~     treating patients with newly diagnosed acute lymphoblastic leukemia~   "
269332|NCT00016289|"~     Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating~     patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may~     kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white~     blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity~     may kill cancer cells~   "
269333|NCT00016263|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Oblimersen (G3139) may help dacarbazine kill more cancer cells by~     making tumor cells more sensitive to the drug. It is not yet known if dacarbazine is more~     effective with or without oblimersen (G3139).~      PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or~     without oblimersen (G3139) in treating patients who have advanced malignant melanoma.~   "
269334|NCT00016224|"~     RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood~     flow to the tumor.~      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have~     epithelial ovarian cancer that has not responded to previous therapy.~   "
269335|NCT00016211|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy~     to the brain may be effective in preventing brain metastases. It is not yet known if~     radiation therapy is effective following chemotherapy in preventing brain metastases.~      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in~     preventing brain metastases in patients who have received chemotherapy for extensive-stage~     small cell lung cancer.~   "
269336|NCT00016185|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol and docetaxel in~     treating patients who have advanced solid tumors.~   "
269337|NCT00016159|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Combining~     monoclonal antibody therapy with chemotherapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and monoclonal~     antibody in treating patients who have acute promyelocytic leukemia.~   "
269338|NCT00016146|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Biological therapies use different ways to stimulate the immune system and stop cancer cells~     from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness in combining vaccine therapy and biological~     therapy in treating patients who have relapsed prostate cancer.~   "
269339|NCT00016133|"~     RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body~     build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with~     chemotherapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with~     leucovorin and fluorouracil in treating patients who have undergone surgery to completely~     remove stage II or stage III colon cancer.~   "
269340|NCT00016094|"~     Phase II trial to study the effectiveness of bevacizumab in treating patients who have~     non-Hodgkin's lymphoma. Monoclonal antibodies such as bevacizumab may stop the growth of~     cancer by stopping blood flow to the tumor. Bevacizumab may be an effective treatment for~     non-Hodgkin's lymphoma~   "
269341|NCT00016081|"~     RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is~     not yet known if ribavirin is more effective than standard therapy in preventing pneumonia in~     patients who have respiratory syncytial virus (RSV) infection following stem cell~     transplantation.~      PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with that of~     standard therapy in preventing pneumonia in patients who have RSV infection following stem~     cell transplantation.~   "
269342|NCT00016068|"~     RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in~     preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing~     cytomegalovirus.~      PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works~     in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.~   "
269343|NCT00016055|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. Combining biological therapy with chemotherapy may~     kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of biological therapy combined with~     temozolomide in treating patients who have metastatic melanoma.~   "
269470|NCT00006456|"~     RATIONALE: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less~     damage to normal tissue.~      PURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating~     patients who have liver metastases, lung metastases, or other advanced solid tumors.~   "
269344|NCT00016029|"~     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective~     treatment for cancer. New diagnostic procedures such as computed tomographic colonography may~     provide a less invasive method of identifying patients who have colon cancer.~      PURPOSE: Diagnostic and screening trial to compare the effectiveness of barium enema,~     computed tomographic colonography, and colonoscopy in detecting of colon cancer.~   "
269345|NCT00016016|"~     Phase II trial to study the effectiveness of combining flavopiridol and cytarabine with~     mitoxantrone in treating patients who have acute leukemia. Drugs used in chemotherapy work in~     different ways to stop cancer cells from dividing so they stop growing or die. Combining more~     than one drug may kill more cancer cells.~   "
269346|NCT00015977|"~     RATIONALE: Vaccines made from a patient's white blood cells may make the body build an immune~     response to kill cancer cells. Interleukin-12 may kill cancer cells by stopping blood flow to~     the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining~     vaccine therapy with interleukin-12 may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy combined with~     interleukin-12 in treating patients who have metastatic prostate cancer that has not~     responded to hormone therapy.~   "
269347|NCT00015951|"~     RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill~     them or deliver cancer-killing substances to them without harming normal cells. Combining~     monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic~     cancer.~      PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine~     and mitoxantrone in treating patients who have hematologic cancer.~   "
269348|NCT00015938|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, vinorelbine, and~     filgrastim in treating women who have stage IV breast cancer.~   "
269349|NCT00015925|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of MS-275 in treating patients who have~     hematologic cancer.~   "
269350|NCT00015899|"~     RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for~     cancer cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in~     treating children with recurrent or progressive brain tumors.~   "
269351|NCT00015873|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which combination chemotherapy regimen is most effective for treating infants~     with acute lymphoblastic leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination~     chemotherapy regimens in treating infants who have newly diagnosed acute lymphoblastic~     leukemia.~   "
269352|NCT00015860|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining~     chemotherapy and STI571 may kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus STI571~     in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia.~   "
269353|NCT00015847|"~     RATIONALE: Imatinib mesylate and interferon alfa may interfere with the growth of the cancer~     cells. Combining imatinib mesylate with interferon alfa may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with~     interferon alfa in treating patients who have chronic myelogenous leukemia.~   "
269354|NCT00015834|"~     Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating~     patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways~     to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of~     leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells~   "
269355|NCT00014612|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less~     invasive treatment and cause fewer side effects than complete axillary lymph node dissection.~     It is not yet known which treatment is more effective for invasive breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph~     node dissection with that of axillary radiation therapy in treating women who have invasive~     breast cancer.~   "
269356|NCT00014599|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who~     have locally advanced, metastatic, or recurrent cancer of the vulva.~   "
269357|NCT00014586|"~     RATIONALE: Testosterone can stimulate the growth of cancer cells. Bicalutamide and goserelin~     may fight prostate cancer by reducing the production of testosterone. It is not yet known~     which hormone therapy regimen is most effective for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of bicalutamide with that of~     observation followed by bicalutamide plus either goserelin or orchiectomy for patients who~     have prostate cancer.~   "
269358|NCT00014521|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of karenitecin in treating patients who~     have recurrent malignant glioma.~   "
269359|NCT00014508|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may be able to replace~     immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are~     rejected by the body's tissues. Peripheral stem cell transplantation with the person's own~     stem cells followed by donor peripheral stem cell transplantation may prevent this from~     happening.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with autologous~     peripheral stem cell transplantation and donor peripheral stem cell transplantation in~     treating patients who have multiple myeloma.~   "
270157|NCT00051454|"~     This study will examine the safety and immune response to a two-part HIV vaccine. Healthy~     volunteers who are at low risk of HIV infection will receive either active vaccine or a~     placebo.~   "
269360|NCT00014495|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill~     more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy and monoclonal~     antibody therapy in treating patients who have advanced myeloid cancer.~   "
269361|NCT00014482|"~     RATIONALE: Music therapy may be effective in relieving pain and emotional distress in~     patients who are undergoing cancer therapy.~      PURPOSE: Randomized trial to determine the effectiveness of music therapy to ease pain and~     emotional distress in patients with hematologic cancer who are undergoing high-dose therapy~     and stem cell transplantation.~   "
269362|NCT00014469|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of busulfan and melphalan followed by~     donor bone marrow transplantation in treating patients who have advanced hematologic cancer.~   "
269363|NCT00014456|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus filgrastim~     in treating patients who have advanced solid tumors.~   "
269364|NCT00014443|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to~     the tumor.~      PURPOSE: Phase I trial to study the effectiveness of combining topotecan and thalidomide in~     treating patients who have recurrent or refractory malignant glioma.~   "
269365|NCT00014378|"~     RATIONALE: The Chinese herb Huang Lian contains ingredients that may slow the growth of~     cancer cells and may be an effective treatment for solid tumors.~      PURPOSE: Phase I trial to study the effectiveness of Huang Lian in treating patients who have~     advanced solid tumors.~   "
269366|NCT00014326|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     therapy in different ways may kill more tumor cells. It is not yet known which regimen of~     radiation therapy is more effective for non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the~     involved area with or without total-body irradiation in treating patients who have low-grade~     stage I or stage II non-Hodgkin's lymphoma that has not previously been treated.~   "
269367|NCT00014313|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have metastatic Ewing's sarcoma or primitive neuroectodermal tumor.~   "
269368|NCT00014274|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is most effective for transitional cell~     cancer of the urothelium.~      PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens~     in treating patients who have transitional cell cancer of the urothelium.~   "
269369|NCT00014235|"~     This clinical trial studies fludarabine phosphate and total-body radiation followed by donor~     peripheral blood stem cell transplant and immunosuppression in treating patients with~     hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor~     peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop~     the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted~     cells from a donor can make an immune response against the body's normal cells. Giving~     total-body irradiation together with fludarabine phosphate, cyclosporine, and mycophenolate~     mofetil before transplant may stop this from happening.~   "
269370|NCT00014222|"~     RATIONALE:~        1. . To compare the effects on breast cancer of three different combinations of drugs which~          are commonly used to treat this disease.~        2. . It is not yet known which treatment regimen is most effective for breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     given with or without epoetin alfa in treating women who have undergone surgery for stage I,~     stage II, or stage III breast cancer.~   "
269371|NCT00014196|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation~     therapy in treating patients who have stage IIIB non-small cell lung cancer.~   "
269372|NCT00014131|"~     RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body~     build an immune response to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     who have recurrent or stage III or stage IV kidney cancer.~   "
269373|NCT00014118|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer~     of the larynx or stage III or stage IV cancer of the oropharynx.~   "
269374|NCT00014092|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa~     stimulate a person's white blood cells to kill cancer cells or may interfere with the growth~     of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim,~     interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that~     cannot be treated with surgery.~   "
269376|NCT00012389|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if irinotecan is more effective with or without~     oxaliplatin in treating metastatic colorectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or~     without oxaliplatin in treating patients who have metastatic colorectal cancer.~   "
269377|NCT00012376|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Colony-stimulating factors such as sargramostim may increase the number of~     immune cells found in bone marrow or peripheral blood and may help a person's immune system~     recover from the side effects of chemotherapy. Phase I trial to study the effectiveness of~     bryostatin 1 combined with sargramostim in treating patients who have refractory myeloid~     cancer~   "
269378|NCT00012363|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have metastatic or recurrent cancer of the esophagus.~   "
269379|NCT00012324|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which chemotherapy regimen is more effective~     for liver cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different~     chemotherapy regimens in treating patients who have recurrent or unresectable liver cancer.~   "
269380|NCT00012298|"~     Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody~     therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who~     have relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies can~     locate cancer cells and deliver cancer-killing substances to them without harming normal~     cells. Biological therapies such as filgrastim and interleukin-11 use different ways to~     stimulate the immune system and stop cancer cells from growing.~   "
269381|NCT00012246|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two different vaccines in~     treating patients who have cancer of the gastrointestinal tract.~   "
269382|NCT00012220|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if gemcitabine is more effective when given~     alone or in combination with another chemotherapy drug in treating cancer of the pancreas.~      PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or~     in combination with other chemotherapy drugs in treating patients who have metastatic cancer~     of the pancreas.~   "
269383|NCT00012207|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Drugs used in chemotherapy use different ways to stop cancer cells~     from dividing so they stop growing or die. Combining biological therapy with chemotherapy may~     kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of biological therapy after chemotherapy in~     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.~   "
269384|NCT00012194|"~     Phase I trial to study the effectiveness of combining UCN-01 with cisplatin in treating~     patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of~     tumor cells by blocking the enzymes necessary for tumor cell growth and may help cisplatin~     kill more cancer cells by making tumor cells more sensitive to the drug.~   "
269385|NCT00012181|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children~     who have relapsed or refractory solid tumors or lymphoma.~   "
269386|NCT00012168|"~     RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to~     detect the spread of mouth and throat cancer to lymph nodes in the neck.~      PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and~     sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have~     mouth or throat cancer.~   "
269387|NCT00012103|"~     RATIONALE: Imaging procedures such as computed tomography may improve the ability to detect~     lung cancer earlier.~      PURPOSE: Screening and diagnostic study of computed tomography in women who are at risk for~     lung cancer.~   "
269388|NCT00012064|"~     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune~     response to kill tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     who have stage IV or recurrent melanoma.~   "
269389|NCT00012051|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Peripheral stem cell~     transplant may be able to replace immune cells that were destroyed by the chemotherapy.~     Monoclonal antibodies, such as rituximab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. It is not yet known if giving more than one~     drug (combination chemotherapy) plus peripheral stem cell transplant is more effective with~     or without monoclonal antibody therapy in treating non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying how well chemotherapy plus peripheral~     stem cell transplant with or without monoclonal antibody therapy works in treating patients~     with relapsed non-Hodgkin's lymphoma.~   "
269390|NCT00012038|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of irofulven in treating patients who~     have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme.~   "
269391|NCT00012025|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who~     have metastatic breast cancer that has not responded to previous hormone therapy.~   "
269486|NCT00006360|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating~     patients who have stage II or stage III oropharyngeal cancer.~   "
269392|NCT00012012|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor~     cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.~     Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.~      PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation~     therapy with or without amifostine in treating patients who have stage IIIB or stage IVA~     cancer of the cervix.~   "
269393|NCT00011999|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy following surgery may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in~     treating patients who have undergone surgery for stage III or stage IV head and neck cancer.~   "
269394|NCT00011986|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. It is not yet known which combination chemotherapy regimen is most effective~     in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to~     compare the effectiveness of various combination chemotherapy regimens in treating patients~     who have stage III or stage IV ovarian cancer or primary peritoneal cancer.~   "
269395|NCT00011960|"~     RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel use different ways to~     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Cisplatin and paclitaxel may make the tumor cells~     more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.~      PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and~     radiation therapy with or without fluorouracil in treating patients who have stage IB, stage~     IIB, or stage IIIB stomach cancer that has been removed during surgery.~   "
269396|NCT00011921|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving chemotherapy with peripheral stem cell transplant or bone~     marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill~     more tumor cells. It is not yet known whether high-dose chemotherapy plus peripheral stem~     cell or bone marrow transplant is more effective than chemotherapy alone in treating small~     cell lung cancer.~      PURPOSE: This randomized phase III trial is studying how well chemotherapy followed by~     peripheral stem cell or bone marrow transplant works compared to chemotherapy alone in~     treating patients with limited-stage or extensive-stage small cell lung cancer.~   "
269397|NCT00010270|"~     RATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal~     cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon~     or rectal cancer.~      PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients~     who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer.~   "
269398|NCT00010257|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in~     treating patients who have advanced thymoma.~   "
269399|NCT00010218|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who~     have relapsed or refractory non-small cell lung cancer~   "
269400|NCT00010205|"~     This phase I trial is studying the side effects and best dose of benzoylphenylurea in~     treating patients with advanced cancer. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die~   "
269401|NCT00010192|"~     Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or~     deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may~     stimulate a person's white blood cells to kill cancer cells. Combining rituximab with~     interleukin-2 may kill more cancer cells. Phase I trial to study the effectiveness of~     rituximab plus interleukin-2 in treating patients who have hematologic cancer.~   "
269402|NCT00010166|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may~     make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation~     therapy after surgery may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation~     therapy in treating patients who have undergone surgery to remove cancer of the pancreas.~   "
269403|NCT00010153|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent~     metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer~     metastases.~      PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before~     surgery in treating women who have stage I or stage II primary breast cancer.~   "
269404|NCT00010140|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Hormone therapy using tamoxifen may fight breast cancer by blocking~     the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may~     kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen~     with or without docetaxel in treating postmenopausal women who have breast cancer that has~     spread to the lymph nodes.~   "
269405|NCT00010101|"~     RATIONALE: Genetic studies may help in understanding the genetic processes involved in the~     development of some types of cancer.~      PURPOSE: Genetic study to understand how genes may be involved in the development of brain~     tumors in young children.~   "
269406|NCT00010075|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     older women who have metastatic breast cancer.~   "
269517|NCT00006227|"~     This phase II trial studies the effectiveness of paclitaxel in treating patients who have~     ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die.~   "
269407|NCT00010062|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.~      PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation~     therapy in treating patients who have undergone surgery for pancreatic cancer.~   "
269408|NCT00010049|"~     RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an~     effective treatment for recurrent glioma and meningioma.~      PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating~     patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.~   "
269409|NCT00010023|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of capecitabine combined with cisplatin in~     treating patients who have locally advanced or metastatic solid tumors .~   "
269410|NCT00009984|"~     This randomized phase II trial is studying thalidomide and fludarabine to see how well they~     work compared to thalidomide alone in treating patients with hematologic cancer that has not~     responded to previous treatment with fludarabine. Thalidomide may stop the growth of~     hematologic cancer by stopping blood flow to the cancer. Combining thalidomide with~     fludarabine may increase the effectiveness of chemotherapy by making cancer cells more~     sensitive to the drug. It is not yet known whether thalidomide is more effective with or~     without fludarabine for hematologic cancer.~   "
269411|NCT00009971|"~     Phase II trial to study the effectiveness of fenretinide in treating patients who have~     recurrent small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die.~   "
269412|NCT00009945|"~     RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and~     other parts of the body. It is not yet known whether clodronate is more effective alone or~     combined with chemotherapy and /or hormonal therapy in preventing metastatic breast cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of clodronate with or~     without chemotherapy and /or hormonal therapy in preventing metastases in women who have~     stage I or stage II breast cancer.~   "
269413|NCT00009880|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy and radiation therapy may kill more tumor cells.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy~     plus radiation therapy with and without fluorouracil in treating patients who have cancer of~     the esophagus or stomach.~   "
269414|NCT00009854|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I/II trial to study the effectiveness of carmustine followed by surgery in~     treating patients who have recurrent supratentorial malignant glioma or metastatic brain~     neoplasm.~   "
269415|NCT00009776|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Combining monoclonal antibody~     therapy with cyclosporine and paclitaxel may be an effective treatment for non-Hodgkin's~     lymphoma.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy~     combined with paclitaxel and cyclosporine in treating patients who have recurrent or~     refractory non-Hodgkin's lymphoma.~   "
269416|NCT00009763|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Combining monoclonal antibody~     therapy with cyclosporine and paclitaxel may be an effective treatment for metastatic breast~     cancer.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody~     therapy, cyclosporine, and paclitaxel in treating patients who have recurrent or refractory~     metastatic breast cancer.~   "
269417|NCT00009750|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy and chemotherapy with peripheral stem cell~     transplantation may be an effective treatment for metastatic prostate cancer.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus~     chemotherapy followed by peripheral stem cell transplantation in treating patients who have~     metastatic prostate cancer that has not responded to hormone therapy.~   "
269418|NCT00009711|"~     RATIONALE: Assessing the long-term effects of bone marrow transplant on lung function in~     patients may improve the ability to plan treatment.~      PURPOSE: This clinical trial studies lung function in pediatric patients who have undergone~     bone marrow transplant.~   "
269419|NCT00008697|"~     The purpose of this study is to evaluate both the efficacy and toxicity of infusional arsenic~     trioxide in the treatment of patients with relapsed or refractory acute promyelocytic~     leukemia (APML). In addition, correlation between pharmacokinetic data and both therapeutic~     response and therapy-related toxicities will be sought.~   "
269420|NCT00008437|"~     RATIONALE: Imaging procedures, such as MRI, may allow the doctor to better detect the tumor.~     Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor~     cells without affecting the surrounding tissue.~      PURPOSE: Phase II trial to study the effectiveness of MRI-guided ultrasound energy in~     treating women who have stage I, stage II, or stage IIIA breast cancer.~   "
269421|NCT00008411|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating~     patients who have metastatic breast cancer.~   "
269422|NCT00008385|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. It is not yet known if selenium is effective in~     preventing the growth of new tumors in patients with previously resected non-small cell lung~     cancer.~      PURPOSE: This randomized phase III trial is studying selenium to see how well it works~     compared to a placebo in preventing the development of second primary lung tumors in patients~     who have undergone surgery to remove stage I non-small cell lung cancer.~   "
269423|NCT00008346|"~     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective~     treatment for cancer. It is not yet known which type of mammography is more effective in~     detecting breast cancer.~      PURPOSE: Screening and diagnostic trial to compare the effectiveness of two types of~     mammography in detecting breast cancer in women.~   "
269424|NCT00008307|"~     RATIONALE: Giving chemotherapy drugs, such as fludarabine and melphalan, before a donor bone~     marrow transplant or peripheral blood stem cell transplant helps stop the patient's immune~     system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal~     cells. When the healthy stem cells from a donor are infused into the patient they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by~     donor bone marrow transplant or peripheral stem cell transplant works in treating patients~     with hematologic cancer or genetic disorders.~   "
269425|NCT00008294|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Cryosurgery kills cancer cells by freezing them. Combining more~     than one chemotherapy drug with cryosurgery and giving drugs in different ways may kill more~     tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of intrahepatic and intravenous combination~     chemotherapy with or without cryosurgery in treating unresectable liver metastases from~     colorectal cancer.~   "
269426|NCT00008268|"~     RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood.~      PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in~     stimulating peripheral stem cells in patients who have multiple myeloma.~   "
269427|NCT00008216|"~     RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor peripheral~     blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets.~      PURPOSE: This phase II trial is studying the effectiveness of donor peripheral blood stem~     cell transplant in treating patients with hematologic cancer.~   "
269428|NCT00008190|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation and interleukin-2 in treating patients who have acute~     leukemia.~   "
269429|NCT00008164|"~     RATIONALE: Umbilical cord blood or placental blood transplantation may be able to replace~     immune cells that were destroyed by the chemotherapy or radiation therapy that was used to~     kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood and placental~     blood transplantation in treating patients who have hematologic cancer or aplastic anemia.~   "
269430|NCT00008138|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug or combining chemotherapy with surgery~     may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in~     treating patients who have stage III or stage IV ovarian epithelial cancer, primary~     peritoneal cancer, or fallopian tube cancer.~   "
269431|NCT00008060|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of combination chemotherapy is more effective for advanced colorectal~     cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil combined~     with leucovorin and either irinotecan or oxaliplatin in treating patients who have~     unresectable metastatic colorectal cancer.~   "
269432|NCT00008047|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy~     with or without paclitaxel combined with radiation therapy in treating patients who have~     stage II or stage III cancer of the esophagus.~   "
269433|NCT00008008|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell or bone~     marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill~     more tumor cells.~      PURPOSE: This phase II trial is studying how well thiotepa followed by peripheral stem cell~     or bone marrow transplant works in treating patients with malignant glioma.~   "
269434|NCT00007995|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell~     transplant work in treating patients with multiple myeloma or primary systemic amyloidosis.~   "
269435|NCT00007982|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell~     transplant work in treating patients with central nervous system cancer.~   "
269436|NCT00007956|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have recurrent or refractory lymphoma.~   "
269437|NCT00007930|"~     RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is~     not yet known whether one type of surgery is more effective than another for rectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in~     treating patients who have rectal cancer.~   "
269438|NCT00007904|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy. Radiation therapy uses~     high-energy x-rays to damage tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA~     breast cancer.~   "
269439|NCT00007891|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell~     transplantation or bone marrow transplantation may be able to replace immune cells that were~     destroyed by monoclonal antibody therapy used to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy~     followed by bone marrow or peripheral stem cell transplantation in treating patients who have~     metastatic breast cancer.~   "
269440|NCT00007865|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells~     and either kill them or deliver cancer-killing substances to them without harming normal~     cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with~     rituximab in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.~   "
269441|NCT00007826|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Vaccines made from cancer~     cells may make the body build an immune response to kill colorectal tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy and/or~     vaccine therapy in treating patients who have locally advanced or metastatic colorectal~     cancer.~   "
269442|NCT00006994|"~     RATIONALE: Glutamine may be effective in decreasing side effects, such as inflammation of the~     mouth and throat, caused by radiation therapy. The effectiveness of glutamine for mucositis~     is not yet known.~      PURPOSE: Randomized phase III trial to determine the effectiveness of glutamine in treating~     patients who develop mucositis following radiation therapy for newly diagnosed cancer of the~     mouth or throat.~   "
269443|NCT00006981|"~     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.~     Immunotoxin therapy may be an effective treatment for advanced cancer.~      PURPOSE: Phase I trial to study the effectiveness of immunotoxins in treating patients who~     have advanced cancer.~   "
269444|NCT00006942|"~     Phase II trial to study the effectiveness of combining bryostatin 1 and cisplatin in treating~     patients who have advanced recurrent or residual ovarian epithelial, fallopian tube, or~     primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. Combining more than one drug may kill more tumor~     cells.~   "
269445|NCT00006929|"~     Phase II trial to study the effectiveness of combining suramin, paclitaxel, and carboplatin~     in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Drugs used~     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than one drug may kill more tumor cells.~   "
269446|NCT00006916|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin~     in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.~   "
269447|NCT00006903|"~     This phase II trial is studying fulvestrant to see how well it works in treating patients~     with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the~     growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the~     uptake of estrogen by the tumor cells.~   "
269448|NCT00006825|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing.~     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy~     with monoclonal antibody therapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab~     in treating women who have advanced breast cancer.~   "
269449|NCT00006773|"~     Phase I trial to study the effectiveness of bortezomib in treating patients who have~     recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes~     necessary for tumor cell growth~   "
269450|NCT00006760|"~     RATIONALE: Drugs used in chemotherapy, such as ifosfamide and vinorelbine, work in different~     ways to stop cancer cells from dividing so they stop growing or die. Combining more than one~     drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     children who have refractory or relapsed Hodgkin's lymphoma.~   "
269451|NCT00006747|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~     Peripheral stem cell transplantation may be able to replace immune cells that were destroyed~     by chemotherapy used to kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     donor peripheral stem cell transplantation in treating patients who have mantle cell~     lymphoma.~   "
269452|NCT00006734|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. It is not yet known which chemotherapy regimen combined with radiation therapy~     and/or surgery is more effective in treating Ewing's sarcoma or primitive neuroectodermal~     tumor.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy~     regimens combined with radiation therapy and/or surgery in treating patients who have Ewing's~     sarcoma or primitive neuroectodermal tumor.~   "
269518|NCT00006226|"~     Phase II trial to study the effectiveness of thalidomide in treating patients who have~     relapsed chronic lymphocytic leukemia. Thalidomide may stop the growth of chronic lymphocytic~     leukemia by stopping blood flow to the tumor.~   "
269453|NCT00006721|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either~     kill them or deliver radioactive tumor-killing substances to them without harming normal~     cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is~     more effective in treating non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given~     together with combination chemotherapy to see how well they work in treating patients with~     newly-diagnosed non-Hodgkin's lymphoma.~   "
269454|NCT00006695|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die. Combining~     chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses~     of chemotherapy drugs and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well monoclonal antibody therapy, chemotherapy,~     and peripheral stem cell transplant work in treating patients with relapsed or refractory~     non-Hodgkin's lymphoma.~   "
269455|NCT00006656|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who~     have progressive or recurrent glioblastoma multiforme.~   "
269456|NCT00006485|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with irinotecan~     in treating patients who have locally advanced or metastatic solid tumors.~   "
269457|NCT00006479|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and combining chemotherapy with~     surgery may kill more tumor cells. It is not yet known if surgery is more effective with or~     without chemotherapy for liver metastases.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without~     combination chemotherapy in treating patients who have liver metastases from colorectal~     cancer.~   "
269458|NCT00006478|"~     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune~     response to kill cancer cells. Vaccine therapy may be an effective treatment for~     non-Hodgkin's lymphoma.~      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy~     and peripheral stem cell transplantation in treating patients who have non-Hodgkin's~     lymphoma.~   "
269459|NCT00006477|"~     RATIONALE: Mistletoe lectin may slow the growth of cancer cells and be an effective treatment~     for solid tumors.~      PURPOSE: Phase I trial to study the effectiveness of mistletoe lectin in treating patients~     who have refractory advanced solid tumors.~   "
269460|NCT00006476|"~     RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor.~      PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have~     recurrent bladder cancer.~   "
269461|NCT00006474|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and~     O6-benzylguanine in treating patients who have newly diagnosed, recurrent, or progressive~     anaplastic glioma.~   "
269462|NCT00006473|"~     Phase II trial to study the effectiveness of oxaliplatin in treating patients who have~     relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways~     to stop tumor cells from dividing so they stop growing or die~   "
269463|NCT00006471|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who~     have recurrent or metastatic head and neck cancer.~   "
269464|NCT00006470|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining these two treatments may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with~     radiation therapy in treating patients who have stage II or stage IIIA non-small cell lung~     cancer that has been completely removed in surgery.~   "
269465|NCT00006469|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining these treatments before surgery may kill more tumor cells in patients with~     non-small cell lung cancer.~      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation~     therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or~     stage IIIA non-small cell lung cancer.~   "
269466|NCT00006468|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of combination chemotherapy is more effective for metastatic~     colorectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients who have metastatic colorectal cancer.~   "
269467|NCT00006465|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced solid tumors.~   "
269468|NCT00006462|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who~     have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.~   "
269469|NCT00006461|"~     This phase III trial is studying how well combination chemotherapy followed by second-look~     surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma~     or primitive neuroectodermal tumor. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy~     x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with~     surgery and radiation therapy may kill more tumor cells.~   "
269471|NCT00006455|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective for treating anaplastic~     large cell lymphoma.~      PURPOSE: This randomized phase III trial is studying several different regimens of~     combination chemotherapy to compare how well they work in treating children with anaplastic~     large cell lymphoma.~   "
269472|NCT00006392|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be~     more effective in preventing prostate cancer.~      PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E,~     either alone or together, in preventing prostate cancer.~   "
269473|NCT00006391|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with topotecan in~     treating patients who have previously treated ovarian epithelial, primary peritoneal, or~     fallopian tube cancer.~   "
269474|NCT00006390|"~     RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells. Peripheral~     stem cell transplantation may be able to replace immune cells that were destroyed by~     chemotherapy or radiation therapy. Combining monoclonal antibody therapy, chemotherapy,~     radiation therapy, and peripheral stem cell transplantation may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell~     transplantation in treating patients who have chronic lymphocytic leukemia.~   "
269475|NCT00006389|"~     Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients~     who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different~     ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase~     the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining~     cisplatin with bryostatin 1 may kill more tumor cells.~   "
269476|NCT00006386|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by~     carmustine in treating patients who have supratentorial glioblastoma multiforme.~   "
269477|NCT00006385|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~     Biological therapies such as sargramostim and interferon alfa use different ways to stimulate~     the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy~     if more effective with or without biological therapy for melanoma.~      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or~     without biological therapy in treating patients who have metastatic melanoma.~   "
269478|NCT00006381|"~     RATIONALE: Celecoxib may be effective in preventing the further development of cancer.~     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Combining trastuzumab~     with celecoxib may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and trastuzumab in~     treating women who have metastatic breast cancer that has not responded to previous~     trastuzumab.~   "
269479|NCT00006379|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may be able to replace~     immune cells that were destroyed by chemotherapy used to kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation in treating patients who have hematologic cancer or~     aplastic anemia.~   "
269480|NCT00006373|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     autologous bone marrow transplantation or peripheral stem cell transplantation in treating~     patients who have non-Hodgkin's lymphoma or Hodgkin's lymphoma.~   "
269481|NCT00006372|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced solid tumors.~   "
269482|NCT00006366|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known which regimen of radiation therapy plus chemotherapy is more~     effective for rectal cancer.~      PURPOSE: Randomized phase II trial to compare two regimens of radiation therapy plus~     chemotherapy followed by surgery in treating patients who have locally advanced cancer of the~     rectum.~   "
269483|NCT00006364|"~     Phase II trial to study the effectiveness of homoharringtonine in treating patients who have~     chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as~     homoharringtonine, work in different ways to stop cancer cells from dividing so they stop~     growing or die~   "
269484|NCT00006363|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells~     more sensitive to the drugs. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. This~     randomized phase III trial is studying giving combination chemotherapy together with PSC 833~     followed by a peripheral stem cell transplant with or without interleukin-2 to see how well~     it works compared to combination chemotherapy alone followed by a peripheral stem cell~     transplant with or without interleukin-2 in treating patients with acute myeloid leukemia.~   "
269485|NCT00006362|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have~     advanced cancer.~   "
269487|NCT00006359|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as~     leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making~     androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these~     drugs together with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide~     or goserelin and either flutamide or bicalutamide together with radiation therapy works in~     treating patients with prostate cancer.~   "
269488|NCT00006356|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so~     that it can be removed during surgery.~      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy with or~     without surgery in treating patients who have recurrent epithelial ovarian cancer.~   "
269489|NCT00006355|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy and radiation therapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of pyrazoloacridine followed by~     radiation therapy in treating adults who have newly diagnosed supratentorial glioblastoma~     multiforme.~   "
269490|NCT00006354|"~     RATIONALE: Mistletoe lectin may slow the growth of cancer cells and be an effective treatment~     for solid tumors.~      PURPOSE: Phase I trial to study the effectiveness of mistletoe lectin in treating patients~     who have advanced solid tumors that have not responded to previous therapy.~   "
269491|NCT00006351|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining SCH 66336 and gemcitabine may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating~     patients who have advanced cancer of the urinary tract.~   "
269492|NCT00006347|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have relapsed or refractory small cell lung cancer.~   "
269493|NCT00006340|"~     RATIONALE: The Epstein Barr virus can cause cancer and lymphoproliferative disorders.~     Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Arginine butyrate~     may make virus cells more sensitive to ganciclovir. Combining ganciclovir and arginine~     butyrate may kill more Epstein Barr virus cells and tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of arginine butyrate plus ganciclovir in~     treating patients who have cancer or lymphoproliferative disorders that are associated with~     the Epstein Barr virus.~   "
269494|NCT00006268|"~     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.~     This may be an effective treatment for malignant glioma.~      PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating~     patients who have malignant glioma.~   "
269495|NCT00006267|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer.~   "
269496|NCT00006264|"~     RATIONALE: Antiviral drugs such as zidovudine and ganciclovir act against viruses and may be~     an effective treatment for HIV. Interleukin-2 may stimulate a person's white blood cells to~     kill lymphoma cells. Combining these treatments may be effective in treating AIDS-related~     primary central nervous system lymphoma.~      PURPOSE: Phase II trial to study the effectiveness of combining zidovudine, ganciclovir, and~     interleukin-2 in treating patients who have AIDS-related primary central nervous system~     lymphoma.~   "
269497|NCT00006263|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide,~     and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.~   "
269498|NCT00006260|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Drugs such~     as mesna may be effective in preventing some of the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of~     etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have~     metastatic breast cancer.~   "
269499|NCT00006258|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug or combining chemotherapy with radiation therapy may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     radiation therapy in treating patients who have surgically resected, newly diagnosed~     medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected~     ependymoma.~   "
269500|NCT00006256|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining paclitaxel with radiation therapy may kill more tumor cells.~      PURPOSE: This trial is to study the effectiveness of concurrent administration of~     chemotherapy and radiation therapy in treating women who have stage II or stage III breast~     cancer by examining the complications and cosmetic effects.~   "
269501|NCT00006255|"~     RATIONALE: Radiofrequency ablation uses high-frequency electric current to heat and kill~     tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective~     treatment for primary kidney cancer, liver metastases, or other solid tumors.~      PURPOSE: Phase II trial to study the effectiveness of magnetic-resonance-guided~     radiofrequency ablation in treating patients who have primary kidney cancer, liver~     metastases, or other solid tumors.~   "
269519|NCT00006221|"~     Phase I trial to study the effectiveness of BMS-247550 in treating patients who have~     malignant solid tumors or lymphoma. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die.~   "
269502|NCT00006252|"~     RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a~     donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also~     helps stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets.~      PURPOSE: This phase II trial is studying how well fludarabine and cyclophosphamide followed~     by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.~   "
269503|NCT00006250|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known which combination chemotherapy regimen is~     more effective for non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination~     chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's~     lymphoma.~   "
269504|NCT00006249|"~     RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet~     known if this treatment is more effective than observation following surgery for stage III~     melanoma.~      PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in~     treating patients who have undergone surgery for stage III melanoma.~   "
269505|NCT00006248|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have metastatic or recurrent head and neck cancer.~   "
269506|NCT00006246|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the safety of delivering intrathecal busulfan in children and~     adolescents who have refractory CNS cancer and to estimate the maximum tolerated dose of this~     treatment regimen.~   "
269507|NCT00006245|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining flavopiridol and paclitaxel~     in treating patients who have locally advanced or metastatic esophageal cancer that has not~     responded to previous paclitaxel therapy.~   "
269508|NCT00006244|"~     This phase II trial studies the effectiveness of melphalan, peripheral stem cell~     transplantation, and interleukin-2 followed by interferon alfa in treating patients who have~     advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem~     cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill~     more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill~     multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells~   "
269509|NCT00006239|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal~     white blood cells.~      PURPOSE: Phase I trial to study the effectiveness of combining phenylbutyrate and tretinoin~     in treating patients who have hematologic cancer.~   "
269510|NCT00006237|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is~     not yet known whether interferon alfa is more effective with or without combination~     chemotherapy and interleukin-2 for melanoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or~     without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus~     interleukin-2, in treating patients who have melanoma.~   "
269511|NCT00006234|"~     RATIONALE: Radioactive drugs, such as holmium Ho 166 DOTMP, may carry radiation directly to~     cancer cells and not harm normal cells. Peripheral stem cell transplantation may be able to~     replace stem cells that were destroyed by the radioactive drug.~      PURPOSE: This Phase I/II trial is studying the effectiveness of holmium Ho 166 DOTMP followed~     by peripheral stem cell transplantation in treating patients who have metastatic Ewing's~     sarcoma or rhabdomyosarcoma that has spread to the bone.~   "
269512|NCT00006233|"~     RATIONALE: Drugs used in chemotherapy such as fludarabine use different ways to stop tumor~     cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells~     that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells~     can reject the body's normal tissues. Donor lymphocytes that have been treated in the~     laboratory may prevent this.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, total-body irradiation,~     peripheral stem cell transplantation, and lymphocyte infusion in treating patients who have~     stage IV melanoma.~   "
269513|NCT00006232|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which combination chemotherapy regimen is more~     effective for multiple myeloma.~      PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens~     to see how well they work in treating patients with stage II or stage III multiple myeloma.~   "
269514|NCT00006231|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known if radiation therapy is effective in preventing metastatic cancer following surgery.~      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in~     preventing metastatic cancer in patients who have undergone diagnostic procedures to identify~     malignant mesothelioma.~   "
269515|NCT00006230|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients~     who have advanced ovarian cancer.~   "
269516|NCT00006228|"~     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Interleukin-2 may~     stimulate a person's white blood cells to kill breast cancer cells. Phase II trial to study~     the effectiveness of trastuzumab plus interleukin-2 in treating patients who have metastatic~     breast cancer that has not responded to previous trastuzumab therapy.~   "
269520|NCT00006219|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be~     effective in preventing multiple myeloma.~      PURPOSE: Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone~     with that of clarithromycin in treating patients who may be at a high risk of developing~     multiple myeloma.~   "
269521|NCT00006125|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and topotecan in~     treating patients who have relapsed or refractory intermediate-grade or high-grade~     non-Hodgkin's lymphoma.~   "
269522|NCT00006124|"~     This randomized phase IIb/III trial is studying celecoxib to see how well it works in~     preventing disease recurrence in patients who have bladder cancer. Chemoprevention therapy is~     the use of certain drugs to try to prevent the development or recurrence of cancer. The use~     of celecoxib may be an effective way to prevent the recurrence of bladder cancer~   "
269523|NCT00006120|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of~     docetaxel or paclitaxel in treating women who have unresectable locally advanced or~     metastatic breast cancer.~   "
269524|NCT00006119|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who~     have recurrent and/or unresectable meningioma.~   "
269525|NCT00006118|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cisplatin, paclitaxel, and~     gemcitabine in treating patients who have progressive unresectable regional or metastatic~     bladder cancer.~   "
269526|NCT00006114|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have metastatic prostate cancer that has not responded to hormone therapy.~   "
269527|NCT00006113|"~     RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to~     kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use~     different ways to stimulate the immune system and stop cancer cells from growing. Combining~     vaccine therapy with biological therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon~     gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.~   "
269528|NCT00006110|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more~     effective treatment for breast cancer.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal~     antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV~     breast cancer.~   "
269529|NCT00006107|"~     Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating~     patients who have stage III or stage IV head and neck cancer.~   "
269530|NCT00006105|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells~     from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, cisplatin, and~     amifostine following surgery in treating patients who have locally advanced bladder cancer.~   "
269531|NCT00006102|"~     Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who~     have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to~     stop cancer cells from dividing so they stop growing or die.~   "
269532|NCT00006101|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development of cancer. The use of eflornithine (DMFO) may be an effective way to prevent the~     development of prostate cancer.~      PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in~     preventing prostate cancer in patients who are at high risk of developing the disease.~   "
269533|NCT00006100|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Donor white blood cells that are treated in the laboratory with~     Epstein-Barr virus may be effective treatment for Hodgkin's lymphoma.~      PURPOSE: Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific~     cytotoxic T cells in treating patients who have progressive, relapsed, or refractory~     Hodgkin's lymphoma.~   "
269534|NCT00006094|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining~     chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of~     the rectum. Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil,~     and external-beam radiation therapy followed by surgery in treating patients who have locally~     advanced cancer of the rectum~   "
269535|NCT00006093|"~     RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.~      PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who~     have progressive or recurrent malignant glioma.~   "
269536|NCT00006092|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous~     leukemia.~   "
269537|NCT00006089|"~     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or~     deliver tumor-killing substances to them without harming normal cells. Phase II trial to~     study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or~     recurrent endometrial cancer.~   "
269539|NCT00006044|"~     RATIONALE: High doses of testosterone may be effective in killing prostate cancer cells that~     no longer respond to hormone therapy.~      PURPOSE: Phase I trial to study the effectiveness of testosterone in treating patients who~     have progressive prostate cancer that no longer responds to hormone therapy.~   "
269540|NCT00006042|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Bone marrow transplantation may be able to replace immune cells~     that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow~     transplantation in treating patients who have hematologic cancer.~   "
269541|NCT00006040|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver radiation~     to them without harming normal cells. Drugs used in chemotherapy use different ways to stop~     cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation~     may allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more~     cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy~     plus etoposide followed by peripheral stem cell transplantation in treating patients who have~     advanced myelodysplastic syndrome or refractory leukemia.~   "
269542|NCT00006029|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating~     patients who have relapsed or refractory Hodgkin's lymphoma.~   "
269543|NCT00006028|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating~     patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is~     recurrent or has not responded to platinum-based chemotherapy.~   "
269544|NCT00006027|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known if radiation therapy is more effective with or without combination~     chemotherapy for endometrial cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without combination chemotherapy following surgery in treating patients who have stage I or~     stage II endometrial cancer.~   "
269545|NCT00006025|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in~     treating patients who have recurrent malignant glioma.~   "
269546|NCT00006024|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by~     radiation therapy in treating patients who have high-grade malignant glioma.~   "
269547|NCT00006022|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill~     tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.~      PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin~     1 in treating patients who have melanoma or kidney cancer that cannot be removed during~     surgery.~   "
269548|NCT00006021|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by~     making cancer cells more sensitive to the drug.~      PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C~     in treating patients who have recurrent or refractory multiple myeloma.~   "
269549|NCT00006020|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have~     recurrent or refractory acute lymphocytic leukemia.~   "
269550|NCT00006017|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which regimen of rebeccamycin analogue is more~     effective in treating non-small cell lung cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue~     regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung~     cancer.~   "
269551|NCT00006016|"~     This phase II trial is studying the effectiveness of combining thalidomide and~     chemoembolization in treating patients who have liver cancer that cannot be removed by~     surgery. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor.~     Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping~     chemotherapy drugs near the tumor. Combining thalidomide with chemoembolization may kill more~     tumor cells.~   "
269552|NCT00006015|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells.~      PURPOSE: This phase II trial is studying combination chemotherapy plus trastuzumab to see how~     well it works in treating patients with advanced, recurrent, or metastatic colorectal cancer.~   "
269553|NCT00006011|"~     Randomized phase III trial to compare the effectiveness of two combination chemotherapy~     regimens plus radiation therapy in treating patients who have stage III or stage IV~     endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs~     used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one chemotherapy drug with radiation therapy may kill~     more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation~     therapy is more effective for endometrial cancer.~   "
270945|NCT00040534|"~     The purpose of this study is to determine the safety and tolerability of an oral Farnesyl~     Protein Transferase~      Inhibitor (SCH 66336) when given in combination with Gemcitabine and Cisplatin in patients~     with advanced cancer.~   "
269554|NCT00006010|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells.~      PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating~     patients who have unresectable or metastatic liver cancer.~   "
269555|NCT00006007|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in~     treating women who have metastatic breast cancer.~   "
269556|NCT00006006|"~     Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating~     patients who have progressive liver cancer that cannot be surgically removed. Thalidomide may~     stop the growth of liver cancer by stopping blood flow to the tumor. Interferon alfa may~     interfere with the growth of the cancer cells. Combining thalidomide and interferon alfa may~     kill more tumor cells.~   "
269557|NCT00006005|"~     RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to~     the tumor.~      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who~     have recurrent or persistent gynecologic sarcomas.~   "
269558|NCT00006004|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective for treating non-small~     cell lung cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients who have non-small cell lung cancer.~   "
269559|NCT00006003|"~     SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor. Phase~     II trial to study the effectiveness of SU5416 in treating patients who have metastatic~     melanoma that has been previously treated~   "
269560|NCT00005997|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating~     patients who have advanced liver and/or biliary cancer.~   "
269561|NCT00005990|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of R115777 plus topotecan in treating~     patients who have advanced solid tumors.~   "
269562|NCT00005987|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating~     factors such as filgrastim and sargramostim may increase the number of immune cells found in~     bone marrow or peripheral blood and may help a person's immune system recover from the side~     effects of chemotherapy. Interferon alfa may interfere with the growth of cancer cells. It is~     not yet known which treatment regimen is more effective for multiple myeloma.~      PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim with that of~     sargramostim plus chemotherapy, peripheral stem cell transplantation, and interferon alfa in~     treating patients who have multiple myeloma.~   "
269563|NCT00005985|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~     Colony-stimulating factors such as filgrastim may increase the number of immune cells found~     in bone marrow or peripheral blood and may help a person's immune system recover from the~     side effects of chemotherapy.~      PURPOSE: This phase II trial is studying how well giving filgrastim together with~     chemotherapy and peripheral stem cell transplant works in treating patients with Hodgkin's~     lymphoma or non-Hodgkin's lymphoma.~   "
269564|NCT00005984|"~     RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem~     cells move from the patient's bone marrow to the blood so they can be collected and stored.~     Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell~     transplant. The stem cells are returned to the patient to replace the blood-forming cells~     that were destroyed by the chemotherapy and radiation therapy.~      PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed~     by stem cell transplant works in treating patients with chronic phase or accelerated phase~     chronic myelogenous leukemia.~   "
269565|NCT00005983|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or~     without radiation therapy in treating breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy,~     and/or hormone therapy with or without radiation therapy in treating women who have stage II~     breast cancer.~   "
269566|NCT00005982|"~     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop~     growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who~     have recurrent or refractory cutaneous T-cell lymphoma~   "
269567|NCT00005981|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have metastatic colorectal cancer.~   "
269568|NCT00005980|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more~     effective for metastatic breast cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal~     doxorubicin in treating women who have metastatic breast cancer.~   "
269569|NCT00005979|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if combination chemotherapy is more effective with or without irinotecan in~     treating colon cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without irinotecan in treating patients who have stage III colon cancer.~   "
269570|NCT00005976|"~     Phase I/II trial to study the effectiveness of pyrazoloacridine plus carboplatin in treating~     patients who have recurrent glioma. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining more than one drug may kill~     more tumor cells.~   "
269571|NCT00005973|"~     Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid~     tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die~   "
269572|NCT00005970|"~     This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide,~     paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy~     alone in treating women with breast cancer that is human epidermal growth factor receptor 2~     (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the~     lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. It is not yet known whether combination chemotherapy is more effective with or without~     trastuzumab in treating breast cancer.~   "
269573|NCT00005967|"~     Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who~     have advanced hematologic cancer. Drugs used in chemotherapy use different ways to stop~     cancer cells from dividing so they stop growing or die.~   "
269574|NCT00005966|"~     RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide~     may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if~     interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with~     or without thalidomide in treating patients who have previously untreated metastatic or~     unresectable kidney cancer.~   "
269575|NCT00005961|"~     Phase II trial to study the effectiveness of O6-benzylguanine and carmustine in treating~     patients who have unresectable locally recurrent or metastatic melanoma. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining more than once chemotherapy drug may kill more tumor cells.~   "
269576|NCT00005957|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the~     tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation~     therapy to the breast alone following surgery is more effective than radiation therapy to the~     breast plus surrounding tissue in treating invasive breast cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to~     see how well it works compared to radiation therapy to the breast plus surrounding tissue in~     treating women who have undergone surgery for early-stage invasive breast cancer.~   "
269577|NCT00005955|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Chemotherapy combined with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation~     therapy in treating children who have newly diagnosed malignant central nervous system~     tumors.~   "
269578|NCT00005954|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have brain metastases.~   "
269579|NCT00005952|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide~     when given with peripheral stem cell transplantation and to see how well they work in~     treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other~     solid tumors.~   "
269580|NCT00005951|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating~     patients who have recurrent primary malignant glioma.~   "
269581|NCT00005949|"~     Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating~     patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the~     body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's~     white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more~     cancer cells~   "
269582|NCT00005945|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not~     yet known which combination chemotherapy regimen is more effective in treating childhood~     acute lymphoblastic leukemia.~      PURPOSE: This randomized phase III trial is comparing different combination chemotherapy~     regimens to see how well they work in treating children with acute lymphoblastic leukemia.~   "
269583|NCT00005941|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy~     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.~     It also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune system and help destroy any remaining cancer~     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor~     lymphocyte infusion) after the transplant may help increase this effect. Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from~     happening.~      PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant plus~     chemotherapy and total-body irradiation followed by donor white blood cell infusion work in~     treating patients with recurrent metastatic or locally advanced cancer of the cervix or~     vagina that is associated with human papillomavirus.~   "
269584|NCT00005879|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of LY353381 may be an effective way to prevent~     the development of breast cancer in women who have hyperplasia.~      PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing~     breast cancer in women who have hyperplasia.~   "
269585|NCT00005878|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. Celecoxib may be effective in preventing cancer in~     patients with Barrett's esophagus.~      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing~     cancer in patients who have Barrett's esophagus.~   "
269586|NCT00005867|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known which regimen of combination chemotherapy is~     most effective for non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy~     and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.~   "
269587|NCT00005863|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy. It is not yet known whether~     combination chemotherapy with filgrastim and/or tretinoin is more effective than combination~     chemotherapy alone for acute myeloid leukemia.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy with filgrastim~     and/or tretinoin to see how well they work compared to combination chemotherapy alone in~     treating patients with acute myeloid leukemia.~   "
269588|NCT00005859|"~     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary~     for tumor cell growth.~      PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who~     have recurrent or progressive malignant glioma.~   "
269589|NCT00005858|"~     Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have~     advanced colon, breast, non-small cell lung, bladder, pancreatic, or ovarian cancer. The~     LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells.~   "
269590|NCT00005856|"~     This phase I/II trial is studying the side effects and best dose of oxaliplatin in treating~     patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing~   "
269591|NCT00005855|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of efaproxiral when~     given with carmustine and to see how well they work in treating patients with progressive or~     recurrent malignant glioma.~   "
269592|NCT00005853|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Combining different types of biological therapies may kill more~     cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients~     who have myelodysplastic syndrome.~   "
269593|NCT00005851|"~     The reason for doing this study is to see if cancer will respond to immune therapy after~     transplantation of blood stem cells (from the bone marrow) using a new kind of treatment~     regimen that is less toxic than that previously used for blood stem cell transplants. This~     type of transplant uses much less chemotherapy and radiation than standard bone marrow~     transplants. The treatment consists of medications that weaken the immune system so it~     doesn't reject the donor's marrow cells. Researchers hope that the immune cells from the~     donor will attack the tumor. This is called a graft versus tumor effect and has been seen~     in other types of cancer. In addition, 65 days or more after the transplant the patient may~     be eligible for an immune treatment that uses additional immune cells from the donor to~     increase the effect of the stem cells against the cancer.~   "
269594|NCT00005850|"~     This trial is designed to test the efficacy of fluoxetine to improve patient's quality of~     life during chemotherapy. An innovative application of a selective serotonin reuptake~     inhibitor may modulate the effects of fatigue, anxiety and depression which worsen quality of~     life.~   "
269595|NCT00005847|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Biological~     therapies use different ways to stimulate the immune system and stop cancer cells from~     growing. It is not yet known which treatment regimen is more effective in treating metastatic~     prostate cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy~     with that of chemotherapy plus biological therapy in treating patients who have progressive~     or metastatic prostate cancer that has not responded to hormone therapy.~   "
269596|NCT00005844|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who~     have advanced solid tumors.~   "
269597|NCT00005840|"~     This phase I trial is studying the side effects and best dose of combination chemotherapy~     when given with radiation therapy in treating patients with stage III or stage IV endometrial~     cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~   "
269598|NCT00005838|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy~     uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of~     non-small cell lung cancer cells. It is not yet known if combination chemotherapy plus~     radiation therapy is more effective with or without AE-941 for non-small cell lung cancer.~     This randomized phase III trial is studying combination chemotherapy and radiation therapy~     given with AE-941 to see how well they work compared to combination chemotherapy and~     radiation therapy alone in treating patients with stage III non-small cell lung cancer that~     cannot be removed by surgery~   "
269599|NCT00005835|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of melphalan and buthionine sulfoximine~     followed by bone marrow or peripheral stem cell transplantation in treating children who have~     resistant or recurrent neuroblastoma.~   "
269600|NCT00005831|"~     Phase II trial to study the effectiveness of combining trastuzumab with combination~     chemotherapy in treating patients who have locally recurrent or metastatic urinary tract~     cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them~     or deliver tumor-killing substances to them without harming normal cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor~     cells~   "
269601|NCT00005830|"~     Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy~     in treating women who have stage III or stage IV endometrial cancer. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy~     with radiation therapy may kill more tumor cells.~   "
269602|NCT00005825|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have stage IIIB or stage IV non-small cell lung cancer.~   "
269603|NCT00005824|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral~     stem cell transplantation in treating patients who have recurrent or refractory AIDS-related~     lymphoma.~   "
269604|NCT00005823|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known if stronger doses of chemotherapy given over~     a longer period of time are as well tolerated or as effective as less intensive chemotherapy.~      PURPOSE: This randomized phase III trial is studying intensive regimens of chemotherapy to~     see how well they work compared to nonintensive regimens of chemotherapy in treating older~     patients with acute myeloid leukemia or myelodysplastic syndrome.~   "
269605|NCT00005822|"~     RATIONALE: SU5416 may stop the growth of breast cancer by stopping blood flow to the tumor.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and doxorubicin in~     treating patients who have stage IIIB or stage IV inflammatory breast cancer.~   "
269606|NCT00005821|"~     RATIONALE: Diagnostic procedures such as sentinel lymph node biopsy may improve the ability~     to detect breast cancer and determine the extent of disease.~      PURPOSE: Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess~     axillary lymph nodes in women who have stage I or stage II breast cancer.~   "
269607|NCT00005819|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of combination~     chemotherapy in treating patients with advanced solid tumors.~   "
269608|NCT00005817|"~     Randomized phase II trial to compare the effectiveness of two regimens of rebeccamycin~     analogue in treating women who have stage IIIB or stage IV breast cancer. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. The best way to give rebeccamycin analog in breast cancer patients is not yet known~   "
269609|NCT00005815|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Thalidomide may stop the growth of melanoma by stopping blood flow~     to the tumor. Combining chemotherapy with thalidomide may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness temozolomide plus thalidomide in~     treating patients who have stage III or stage IV melanoma that cannot be removed during~     surgery.~   "
269610|NCT00005812|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have leptomeningeal metastases from a solid tumor or lymphoma.~   "
269611|NCT00005811|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. This phase II trial is studying how well topotecan hydrochloride works in~     treating children with meningeal cancer that has not responded to previous treatment~   "
269612|NCT00005808|"~     Phase I trial to study the effectiveness of photodynamic therapy with lutetium texaphyrin in~     treating patients who have cervical intraepithelial neoplasia. Photodynamic therapy uses~     light and drugs such as lutetium texaphyrin that make abnormal cells more sensitive to light~     and may kill abnormal cells in the cervix and prevent the development of cervical cancer~   "
269613|NCT00005807|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have~     metastatic, recurrent, or locally advanced, ovarian cancer, breast cancer, or metastatic or~     unresectable solid tumors.~   "
269614|NCT00005803|"~     This phase I/II trial studies how well autologous stem cell transplant followed by donor stem~     cell transplant works in treating patients with lymphoma that has returned or does not~     respond to treatment. Peripheral blood stem cell transplant using stem cells from the patient~     or a donor may be able to replace immune cells that were destroyed by chemotherapy used to~     kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells~     (graft-versus-tumor effect).~   "
269615|NCT00005802|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill~     leukemia cells. Treating donor white blood cells with interleukin-2 in the laboratory may~     help them kill more cancer cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-2~     when given after chemotherapy and donor white blood cells and to see how well they work in~     treating patients with acute myeloid leukemia or acute lymphoid leukemia.~   "
270946|NCT00040521|"~     The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in~     patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score from~     220-400).~   "
269616|NCT00005797|"~     RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow~     transplant helps stop the growth of cancer cells. It also helps stop the patient's immune~     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are~     infused into the patient they may help the patient's bone marrow make stem cells, red blood~     cells, white blood cells, and platelets.~      PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in~     treating patients with hematologic cancers.~   "
269617|NCT00005788|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells.~      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who~     have mycosis fungoides or Sezary syndrome.~   "
269618|NCT00005787|"~     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were~     destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in~     the laboratory may improve the effectiveness of the transplant.~      PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in~     patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with~     high-dose chemotherapy.~   "
269619|NCT00005786|"~     Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have~     relapsed or refractory lymphoma or leukemia. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die~   "
269620|NCT00005647|"~     RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the~     tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating~     patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.~   "
269621|NCT00005644|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced cancer of the urothelium with decreased kidney function.~   "
269622|NCT00005639|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine plus~     phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not~     responded to previous treatment.~   "
269623|NCT00005638|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus radiation therapy in~     treating patients who have advanced cancer of the esophagus.~   "
269624|NCT00005637|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor~     cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following~     radiation therapy in treating patients who have malignant glioma.~   "
269625|NCT00005627|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of estramustine, docetaxel, and carboplatin~     in treating patients who have prostate cancer that has not responded to hormonal therapy.~   "
269626|NCT00005623|"~     RATIONALE: Cyproterone acetate may be effective treatment for hot flashes following surgical~     or chemical castration for prostate cancer. It is not yet known which regimen of cyproterone~     acetate is more effective for hot flashes.~      PURPOSE: Randomized phase III trial to determine the effectiveness of cyproterone acetate in~     treating patients who have hot flashes following surgical or chemical castration for prostate~     cancer.~   "
269627|NCT00005622|"~     RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow~     transplant helps stop the growth of cancer cells. It also helps stop the patient's immune~     system from rejecting the donor's stem cells. When the stem cells from a related or unrelated~     donor, that closely matches the patient's blood, are infused into the patient they may help~     the patient's bone marrow to make stem cells, red blood cells, white blood cells, and~     platelets.~      PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in~     treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.~   "
269628|NCT00005617|"~     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill~     tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients~     who have stage IV, or relapsed malignant melanoma.~   "
269629|NCT00005606|"~     RATIONALE: Peripheral blood lymphocyte therapy may be effective in the treatment and~     prevention of Epstein-Barr virus infection following transplantation.~      PURPOSE: Phase II trial to study the effectiveness of peripheral blood lymphocyte therapy in~     treating and preventing lymphoproliferative disorders in patients who have Epstein-Barr virus~     infection following transplantation.~   "
269630|NCT00005605|"~     RATIONALE: Tamoxifen may be able to increase bone density and decrease cholesterol in women~     who are undergoing chemotherapy for breast cancer.~      PURPOSE: Clinical trial to study the effectiveness of tamoxifen in preventing bone loss and~     heart disease caused by chemotherapy treatment in premenopausal women who have stage I or~     stage II breast cancer.~   "
269631|NCT00005603|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more~     cancer cells. It is not yet known which combination chemotherapy regimen is more effective~     for acute lymphoblastic leukemia.~      PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy in~     treating children who have newly diagnosed acute lymphoblastic leukemia.~   "
269632|NCT00005602|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as~     carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.~      PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with~     carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.~   "
269633|NCT00005601|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer~     cells and either kill them or deliver cancer-killing substances to them without harming~     normal cells. Combining combination chemotherapy with monoclonal antibody therapy may kill~     more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab~     in treating patients who have relapsed non-Hodgkin's lymphoma.~   "
269634|NCT00005600|"~     RATIONALE: The use of axillary drains may help to prevent complications following axillary~     lymph node dissection.~      PURPOSE: This randomized clinical trial is comparing three methods of axillary drainage to~     see how well they work following lymph node dissection in women with stage I or stage II~     breast cancer.~   "
269635|NCT00005599|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 and paclitaxel in treating~     patients who have locally advanced or metastatic esophageal cancer or stomach cancer.~   "
269636|NCT00005597|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who~     have unresectable or metastatic gastrointestinal stromal tumors.~   "
269637|NCT00005596|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which regimen of chemotherapy is more effective for acute lymphoblastic~     leukemia.~      PURPOSE: This randomized phase III trial is comparing four regimens of combination~     chemotherapy to see how well they work in treating children with newly diagnosed acute~     lymphoblastic leukemia.~   "
269638|NCT00005590|"~     RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection~     in patients receiving chemotherapy for solid tumors or lymphoma. It is not yet known if~     levofloxacin if effective in preventing infection.~      PURPOSE: Randomized phase III trial to determine the effectiveness of levofloxacin in~     preventing infection in patients receiving chemotherapy for solid tumors or lymphoma.~   "
269639|NCT00005589|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies~     such as rituximab can locate cancer cells and either kill them or deliver cancer-killing~     substances to them without harming normal cells. It is not yet known if combination~     chemotherapy plus peripheral stem cell transplantation is more effective with or without~     rituximab for non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and~     peripheral stem cell transplantation together with rituximab to see how well it works~     compared to combination chemotherapy and peripheral stem cell transplantation alone in~     treating patients with relapsed non-Hodgkin's lymphoma.~   "
269640|NCT00005586|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether chemotherapy is more effective than observation in patients who have had~     surgery to remove colorectal cancer.~      PURPOSE: This randomized phase III trial is studying leucovorin and fluorouracil to see how~     well they work compared to observation in treating patients with colorectal cancer that has~     been surgically removed.~   "
269641|NCT00005585|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which regimen of combination chemotherapy is more effective for childhood acute~     lymphoblastic leukemia.~      PURPOSE: This randomized phase III trial is comparing different regimens of combination~     chemotherapy to see how well they work in treating children with acute lymphoblastic~     leukemia.~   "
269642|NCT00005584|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not~     yet known which combination chemotherapy regimen is most effective in treating Hodgkin's~     lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     combination chemotherapy with or without radiation therapy in treating patients who have~     Hodgkin's lymphoma.~   "
269643|NCT00005583|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether radiation therapy with chemotherapy is more effective than~     radiation therapy alone in treating high-risk endometrial cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to~     see how well they work compared to radiation therapy alone in treating patients with~     high-risk endometrial cancer.~   "
269644|NCT00005580|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in~     treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's~     lymphoma.~   "
269645|NCT00005579|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with~     indolent lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.~   "
269646|NCT00005095|"~     RATIONALE: To improve strategies for detection and prevention of early-stage disease.~      PURPOSE: This research study is collecting specimens and data to develop better methods for~     early detection and prevention of ovarian cancer among the high risk population and those who~     have the disease.~   "
269677|NCT00004879|"~     RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them~     or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating~     patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon,~     rectal, esophageal, or gastroesophageal junction cancer.~   "
269647|NCT00005087|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy. Radiation therapy uses~     high-energy x-rays to damage tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim~     combined with radiation therapy in treating patients who have locally recurrent head and neck~     cancer and have received previous treatment with radiation therapy.~   "
269648|NCT00005079|"~     RATIONALE: The timing of breast cancer surgery within the menstrual cycle may affect outcome.~     It is not yet known if treatment is more effective during the initial or final phase of the~     menstrual cycle.~      PURPOSE: Phase III trial to determine the effect of menstrual cycle phase at surgery in~     treating premenopausal women who have stage I, stage II, or stage III breast cancer.~   "
269649|NCT00005074|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who~     have previously untreated or relapsed mantle cell lymphoma.~   "
269650|NCT00005067|"~     This phase I trial is studying the side effects and best dose of photodynamic therapy with~     lutetium texaphyrin in treating patients with locally recurrent prostate cancer. Photodynamic~     therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor~     cells. This may be effective treatment for locally recurrent prostate cancer.~     Photosensitizing drugs, such as lutetium texaphyrin, are absorbed by cancer cells and, when~     exposed to light, become active and kill the cancer cells~   "
269651|NCT00005062|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the~     spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more~     effective than high-dose radiation therapy in preventing the spread of limited-stage small~     cell lung cancer cells to the brain.~      PURPOSE: This randomized phase III trial is comparing two different regimens of radiation~     therapy to see how well they work in treating patients with limited-stage small cell lung~     cancer in complete remission.~   "
269652|NCT00005060|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug with surgery may kill~     more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective~     than surgery followed by chemotherapy for stomach cancer.~      PURPOSE: This randomized phase III trial is studying surgery followed by combination~     chemotherapy to see how well it works compared to combination chemotherapy followed by~     surgery in treating patients with locally advanced stomach cancer.~   "
269653|NCT00005052|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not~     yet known whether vaccine therapy is more effective than observation alone for melanoma.~      PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works~     compared to observation alone in treating patients with primary stage II melanoma.~   "
269654|NCT00005051|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced ovarian epithelial cancer.~   "
269655|NCT00005049|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving them by intraperitoneal~     infusion may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of intraperitoneal combination~     chemotherapy in treating patients who have stage III ovarian epithelial cancer or~     gastrointestinal cancer.~   "
269656|NCT00005047|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether combination chemotherapy is more effective than observation alone in~     treating bladder cancer.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy to see how well~     it works compared to observation alone in treating patients with bladder cancer.~   "
269657|NCT00005044|"~     RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may~     fight prostate cancer by reducing the production of androgens. Radiation therapy uses~     high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone~     therapy and radiation therapy is more effective for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of~     hormone therapy and radiation therapy in treating patients who have prostate cancer.~   "
269658|NCT00005039|"~     Randomized phase II trial to determine the effectiveness of vaccine therapy in treating~     patients who have advanced adenocarcinoma of the prostate (prostate cancer). Vaccines made~     from a person's prostate cancer cells may make the body build an immune response to kill~     tumor cells~   "
269659|NCT00005038|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer~     cells. Histamine dihydrochloride may prolong survival and improve quality of life in patients~     with metastatic kidney cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-2 with or~     without histamine dihydrochloride in treating patients who have metastatic kidney cancer.~   "
269660|NCT00005036|"~     Randomized phase III trial to compare the effectiveness of irinotecan with that of~     combination chemotherapy in treating patients who have advanced colorectal cancer that has~     not responded to previous treatment. Drugs used in chemotherapy use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining more than one drug may kill~     more tumor cells. It is not yet known which chemotherapy regimen is more effective for~     colorectal cancer.~   "
269661|NCT00005033|"~     RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill~     them or deliver tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who~     have recurrent osteosarcoma.~   "
269662|NCT00004936|"~     RATIONALE: Imaging procedures such as MRI or CT scans may improve the ability to detect~     cervical cancer and determine the extent of disease.~      PURPOSE: Diagnostic trial to determine the effectiveness of MRI and CT scans in evaluating~     invasive cervical cancer before treatment of patients.~   "
269663|NCT00004935|"~     RATIONALE: To compare efficacy, toxicity and quality of life of the sequential administration~     of Her alone followed, at PD, by the combination with Chemotherapy (Arm A) vs. the upfront~     combination of Her and Chemotherapy (Arm B) in patients with advanced/metastatic breast~     cancer.~      PURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions~     regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic~     breast cancer.~   "
269664|NCT00004934|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether receiving paclitaxel and carboplatin~     with epirubicin is more effective than paclitaxel and carboplatin alone for ovarian~     epithelial, fallopian tube, or peritoneal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and~     carboplatin with or without epirubicin in treating patients who have stage IIB, stage III, or~     stage IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer.~   "
269665|NCT00004932|"~     RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an~     effective treatment for leukemia.~      PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients~     who have recurrent leukemia.~   "
269666|NCT00004930|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients~     who have primary lung cancer or lung metastases.~   "
269667|NCT00004924|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving paclitaxel together with irinotecan~     works in treating patients with advanced non-small cell lung cancer.~   "
269668|NCT00004921|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which chemotherapy regimen is most effective for ovarian epithelial cancer.~      PURPOSE: This randomized phase III trial is studying high-dose chemotherapy to see how well~     it works compared to standard chemotherapy in treating patients with stage III or stage IV~     ovarian epithelial cancer that has been removed during surgery.~   "
269669|NCT00004920|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether receiving cisplatin with raltitrexed is~     more effective than cisplatin alone for malignant mesothelioma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without~     raltitrexed in treating patients who have malignant mesothelioma of the pleura.~   "
269670|NCT00004918|"~     Vaccines made from peptides that are found on leukemia cells may make the body build an~     immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant~     Montanide ISA-51 may be a more effective treatment for chronic myeloid leukemia, acute~     myeloid leukemia, or myelodysplastic syndrome. This phase I/II trial is studying the side~     effects and best dose of vaccine therapy when given with Montanide ISA-51 and to see how well~     they work in treating patients with chronic myeloid leukemia, acute myeloid leukemia, or~     myelodysplastic syndrome~   "
269671|NCT00004917|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may~     stimulate red blood cell production and treat anemia in patients with head and neck cancer.~     It is not yet known whether receiving radiation therapy with epoetin alfa is more effective~     than radiation therapy alone in treating anemic patients with head and neck cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without epoetin alfa in treating anemic patients who have head and neck cancer.~   "
269672|NCT00004907|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Bone marrow or peripheral stem cell transplantation may allow the doctor to give~     higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and radiation therapy~     plus bone marrow or peripheral stem cell transplantation in treating patients who have~     refractory or relapsed T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.~   "
269673|NCT00004899|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing and die. Bone marrow transplantation may be able to replace cells that~     were destroyed by chemotherapy. Colony-stimulating factors such as filgrastim may increase~     the number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus bone marrow~     transplantation and filgrastim in treating patients who have acute myelogenous leukemia or~     myelodysplastic syndrome.~   "
269674|NCT00004896|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with donor bone marrow transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of busulfan and cyclophosphamide followed~     by bone marrow transplantation in treating patients who have acute myelogenous leukemia or~     myelodysplastic syndrome.~   "
269675|NCT00004891|"~     RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect~     the extent of locally advanced primary rectal cancer and may also help to measure a patient's~     response to treatment.~      PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or~     metastatic disease in patients with locally advanced primary rectal cancer that can be~     removed during surgery.~   "
269676|NCT00004888|"~     Phase II trial to study the effectiveness of combination chemotherapy with or without~     trastuzumab in treating women who have metastatic breast cancer. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal~     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~   "
269754|NCT00003969|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of a geldanamycin~     analogue in treating patients with advanced cancer.~   "
269678|NCT00004876|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood~     flow to the tumor.~      PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with~     thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial~     cancer.~   "
269679|NCT00004873|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is most effective in treating advanced~     stomach cancer.~      PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of~     combination chemotherapy in treating patients who have advanced stomach cancer.~   "
269680|NCT00004871|"~     RATIONALE: Azacitidine plus phenylbutyrate may help leukemia cells develop into normal white~     blood cells.~      PURPOSE: Phase I trial to study the effectiveness of combining azacitidine and phenylbutyrate~     in treating patients who have acute myeloid leukemia or myelodysplastic syndrome.~   "
269681|NCT00004867|"~     RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to~     determine the stage of esophageal cancer.~      PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 positron emission~     tomography determines tumor stage in patients with esophageal cancer.~   "
269682|NCT00004866|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have~     advanced or recurrent cancer of the cervix.~   "
269683|NCT00004859|"~     This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and~     thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation~     therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping~     blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation~     therapy is more effective with or without thalidomide.~   "
269684|NCT00004262|"~     Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in~     treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the~     tumor cells more sensitive to radiation therapy.~   "
269685|NCT00004259|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop~     tumor cells from dividing so they stop growing or die. Combining radiation therapy with~     chemotherapy may kill more tumor cells.~      PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to~     see how well they work compared to radiation therapy and carmustine or lomustine in treating~     patients with anaplastic astrocytoma or mixed gliomas.~   "
269686|NCT00004250|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Infusing chemotherapy to the tumor area only may kill more tumor~     cells and cause less damage to healthy tissues.~      PURPOSE: This phase II trial is studying isolated limb infusion of chemotherapy to see how~     well it works in treating patients with melanoma or soft tissue sarcoma of the arm or leg~     that cannot be removed by surgery.~   "
269687|NCT00004245|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of sodium salicylate in treating patients~     who have advanced myelodysplastic syndrome , acute myelogenous leukemia or chronic~     lymphocytic leukemia.~   "
269688|NCT00004244|"~     This phase I trial is studying the side effects and best dose of interleukin-12 and~     interferon alfa in treating patients with metastatic kidney cancer or malignant melanoma.~     Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a~     person's white blood cells to kill cancer cells. Interferon alfa may interfere with the~     growth of cancer cells. Combining interleukin-12 and interferon alfa may kill more cancer~     cells.~   "
269689|NCT00004241|"~     Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they~     stop growing or die. This phase I trial is studying the side effects and best dose of~     17-N-allylamino-17-demethoxygeldanamycin in treating patients with advanced epithelial~     cancer, malignant lymphoma, or sarcoma~   "
269690|NCT00004237|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying three regimens of combination~     chemotherapy to compare how well they work in treating women with stage I or stage II breast~     cancer.~   "
269691|NCT00004234|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation~     therapy at different times of the day may affect the chance of developing side effects such~     as mucositis.~      PURPOSE: Randomized phase III trial to compare the incidence of mucositis in patients who~     have cancer of the mouth, pharynx, or larynx, who are receiving radiation therapy in either~     the morning or afternoon.~   "
269692|NCT00004231|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     cancer cells. Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     bone marrow or peripheral stem cell transplantation and/or biological therapy in treating~     patients who have stage III, stage IV, or recurrent mantle cell lymphoma.~   "
269693|NCT00004228|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known which regimen of combination chemotherapy is~     most effective for lymphoblastic lymphoma.~      PURPOSE: This randomized phase III trial is studying different regimens of combination~     chemotherapy to compare how well they work in treating children or adolescents with newly~     diagnosed stage III or stage IV lymphoblastic lymphoma.~   "
269694|NCT00004227|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal~     antibodies such as cetuximab can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. It is not yet known if~     radiation therapy is more effective with or without cetuximab for cancer of the oropharynx,~     hypopharynx, or larynx.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without cetuximab in treating patients who have stage III or stage IV cancer of the~     oropharynx, hypopharynx, or larynx.~   "
269695|NCT00004226|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy following surgery~     in treating patients who have recurrent or second primary cancer of the head and neck~     following previous radiation therapy.~   "
269696|NCT00004225|"~     RATIONALE: Inserting the gene for p53 into a person's cancer cells may improve the body's~     ability to fight cancer. Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of gene therapy plus radiation therapy in~     treating patients who have non-small cell lung cancer.~   "
269697|NCT00004224|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug and combining chemotherapy with radiation therapy may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to~     see how well they work in treating children with localized ependymoma.~   "
269698|NCT00004218|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. It is not yet known which regimen of chemotherapy is more~     effective for chronic lymphocytic leukemia.~      PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works~     compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with~     newly diagnosed chronic lymphocytic leukemia.~   "
269699|NCT00004212|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating children who have~     advanced solid tumors or lymphomas that have not responded to previous therapy.~   "
269700|NCT00004210|"~     RATIONALE: Identifying family and individual characteristics may help plan education and~     counseling for patients who are considering genetic testing.~      PURPOSE: This clinical trial is studying education and counseling to see what effect they~     have in patients who are undergoing genetic testing for hereditary nonpolyposis colon cancer~     (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within~     families already participating continues).~   "
269701|NCT00004208|"~     The main objective of this trial is to evaluate the efficacy and toxicity of intensive~     immuno-suppression with ATG + CSA versus best supportive care in patients with transfusion~     dependent low and intermediate risk myelodysplastic syndrome (MDS).~   "
269702|NCT00004205|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy~     using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor~     cells. If is not yet known which treatment regimen is most effective for breast cancer.~      PURPOSE: Randomized double-blind phase III trial to compare the effectiveness of letrozole~     with that of tamoxifen in treating postmenopausal women who have breast cancer that has been~     surgically removed.~   "
269703|NCT00004196|"~     RATIONALE: Interferon alfa-2b may interfere with the growth of cancer cells.~      PURPOSE: Randomized phase III trial to study the effectiveness of interferon alfa-2b in~     treating patients who have melanoma with early lymph node metastasis.~   "
269704|NCT00004189|"~     Phase I trial to study the effectiveness of rebeccamycin analog and cisplatin with or without~     filgrastim in treating patients who have advanced cancer. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining more~     than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may~     increase the number of immune cells found in bone marrow or peripheral blood and may help a~     person's immune system recover from the side effects of chemotherapy.~   "
269705|NCT00004188|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation~     with treated peripheral stem cells following combination chemotherapy to see how well it~     works compared to peripheral stem cell transplantation with untreated peripheral stem cells~     following combination chemotherapy in treating patients with neuroblastoma.~   "
269706|NCT00004181|"~     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were~     destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation~     in treating patients who have multiple myeloma, chronic phase chronic myelogenous leukemia,~     or agnogenic myeloid metaplasia.~   "
269707|NCT00004179|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells~     and either kill them or deliver cancer-killing substances to them without harming normal~     cells. It is not yet known whether chemotherapy is more effective with or without rituximab~     for relapsed non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab~     to see how well they work compared to combination chemotherapy alone in treating patients~     with relapsed non-Hodgkin's lymphoma.~   "
269708|NCT00004173|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating~     patients who have metastatic or unresectable cancer.~   "
270400|NCT00001424|"~     Patients enrolled in this study will not receive investigational therapy. Any treatments~     rendered will be standard and based on appropriate medical care. Should a patient become~     eligible for an experimental therapy protocol, the normal process of enrollment and informed~     consent will be followed.~   "
269709|NCT00004165|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to~     give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Phase III trial to study the effectiveness of melphalan followed by peripheral stem~     cell transplantation in treating patients who have multiple myeloma.~   "
269710|NCT00004154|"~     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing. It~     is not yet known whether fenretinide is more effective than a placebo in preventing the~     recurrence of bladder cancer after surgery to remove the tumor.~      PURPOSE: This randomized phase III trial is studying fenretinide to see how well it works~     compared to a placebo in treating patients who are at risk for recurrent bladder cancer~     following surgery to remove the tumor.~   "
269711|NCT00004153|"~     RATIONALE: Diagnostic procedures may improve the ability to detect the presence or recurrence~     of disease.~      PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood~     of patients who have melanoma.~   "
269712|NCT00004150|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which chemotherapy regimen is more effective~     for colon cancer.~      PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without~     leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in~     treating patients who have undergone surgery for stage III colon cancer.~   "
269713|NCT00004149|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients~     who have stage IV prostate cancer that has not responded to hormone therapy.~   "
269714|NCT00004147|"~     RATIONALE: COL-3 may stop the growth of brain tumors by stopping blood flow to the tumor.~      PURPOSE: Phase I/II trial to study the effectiveness of COL-3 in treating patients who have~     progressive or recurrent brain tumors following radiation therapy or chemotherapy.~   "
269715|NCT00004144|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in~     treating patients who have advanced cancer that has not responded to previous treatment.~   "
269716|NCT00004143|"~     RATIONALE: Although used primarily to treat malignant disorders of the blood, allogeneic stem~     cell transplantation can also cure a variety of non-cancerous, inherited or acquired~     disorders of the blood. Unfortunately, the conventional approach to allogeneic stem cell~     transplantation is a risky procedure. For some non-cancerous conditions, the risks of this~     procedure outweigh the potential benefits. This protocol is designed to test a new approach~     to allogeneic stem cell transplantation. It is hoped that this approach will be better suited~     for patients with non-cancerous blood and bone marrow disorders.~   "
269717|NCT00004141|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Biological therapies use different ways to stimulate the immune~     system and stop cancer cell from growing. Combining more than one drug with different types~     of biological therapies may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus~     biological therapy in treating patients who have metastatic melanoma.~   "
269718|NCT00004138|"~     RATIONALE: Imaging procedures, such as positron emission tomography (PET), may improve the~     ability to detect the extent of non-small cell lung cancer.~      PURPOSE: Diagnostic trial to study the effectiveness of PET for detecting lesions in patients~     who have newly diagnosed stage I, stage II, or stage IIIA non-small cell lung cancer.~   "
269719|NCT00004135|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune~     cells that were destroyed by chemotherapy used to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell~     transplantation in treating patients who have metastatic kidney cancer or melanoma.~   "
269720|NCT00004129|"~     RATIONALE: Radioactive drugs such as phosphorus 32 may be able to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of phosphorus 32 in~     treating patients with glioblastoma multiforme.~   "
269721|NCT00004128|"~     RATIONALE: Giving combination chemotherapy before a peripheral blood stem cell transplant~     stops the growth of cancer cells by stopping them from dividing or killing them. After~     treatment, stem cells are collected from the patient's blood or bone marrow and stored. More~     chemotherapy or radiation therapy is given prepare the bone marrow for the stem cell~     transplant. The stem cells are then returned to the patient to replace the blood-forming~     cells that were destroyed by the chemotherapy and radiation therapy. Interleukin-2 may~     stimulate the patient's white blood cells to kill cancer cells.~      PURPOSE: This randomized phase III trial is studying two different regimens of combination~     chemotherapy, interleukin-2, and peripheral stem cell transplant and comparing them to see~     how well they work in treating patients with acute myeloid leukemia.~   "
269722|NCT00004124|"~     RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy~     may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy~     use different ways to stop tumor cells from dividing so they stop growing or die. It is not~     yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than~     hormone therapy alone for prostate cancer.~      PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and~     prednisone to see how well they work compared to hormone therapy alone in treating patients~     who have undergone radical prostatectomy for prostate cancer.~   "
269723|NCT00004115|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. It is not yet known whether~     monoclonal antibody therapy is more effective than observation for ovarian cancer or primary~     peritoneal cancer that is in remission.~      PURPOSE: Randomized phase III trial to compare the effectiveness of monoclonal antibody~     therapy with that of observation in treating patients who have ovarian cancer or primary~     peritoneal cancer in remission following surgery and chemotherapy.~   "
269724|NCT00004110|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor~     killing substances to them without harming normal cells. Drugs used in chemotherapy use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining~     monoclonal antibody therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus~     etoposide in treating patients who have neuroblastoma.~   "
269725|NCT00004106|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: This phase II trial is studying temozolomide to see how well it works in treating~     patients with mycosis fungoides or Sezary syndrome that has not responded to previous~     treatment.~   "
269726|NCT00004103|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and combining chemotherapy with~     surgery may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by~     surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.~   "
269727|NCT00004099|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if surgery alone or surgery combined with~     chemotherapy is more effective in treating stomach cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without~     combination chemotherapy in treating patients who have stage II, stage III, or stage IV~     stomach cancer.~   "
269728|NCT00004092|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This randomized phase II trial is studying two different regimens of combination~     chemotherapy and comparing them to see how well they work in treating patients with high-risk~     primary stage II or stage III breast cancer.~   "
269729|NCT00004088|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors~     to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies,~     such as interferon alfa, use different ways to stimulate the immune system and stop cancer~     cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to~     the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma.~      PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell~     transplantation, biological therapy, pamidronate, and thalidomide to see how well they work~     in treating patients with stage I, stage II, or stage III multiple myeloma.~   "
269730|NCT00004081|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have~     ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous~     treatment.~   "
269731|NCT00004077|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, ifosfamide, and~     cisplatin in treating patients who have metastatic testicular cancer that has recurred~     following treatment.~   "
269732|NCT00004075|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     17-N-allylamino-17-demethoxygeldanamycin in treating patients with solid tumors that cannot~     be removed by surgery.~   "
269733|NCT00004072|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine with~     carmustine in treating patients who have previously untreated, refractory, or relapsing~     multiple myeloma.~   "
269734|NCT00004067|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel,~     use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal~     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. It is not yet known whether~     combination chemotherapy plus trastuzumab is more effective than combination chemotherapy~     alone for treating breast cancer.~      PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy~     together with trastuzumab works compared to combination chemotherapy alone in treating women~     with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.~   "
269735|NCT00004066|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the~     number of immune cells found in bone marrow or peripheral blood and may help a person's~     immune system recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, docetaxel, and~     filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft~     tissue sarcoma that cannot be removed by surgery.~   "
269736|NCT00004065|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid~     tumors or hematologic cancers.~   "
269737|NCT00004063|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.~     Hyperthermia therapy kills tumor cells by heating them to several degrees above body~     temperature. Combining hyperthermia with chemotherapy and interferon alfa may kill more tumor~     cells.~      PURPOSE: This phase I/II trial is studying the side effects of cisplatin, gemcitabine,~     interferon alfa, and whole-body hyperthermia and how well they work in treating patients with~     metastatic, recurrent, or refractory cancer.~   "
269738|NCT00004058|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     12-O-tetradecanoylphorbol-13-acetate in treating patients with hematologic cancer or bone~     marrow disorder that has not responded to previous treatment.~   "
269739|NCT00004054|"~     RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy~     may fight prostate cancer by reducing the production of androgens. Radiation therapy uses~     high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die. It is not yet known whether~     hormone therapy plus radiation therapy is more effective with or without combination~     chemotherapy for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus~     radiation therapy with or without combination chemotherapy in treating patients who have~     prostate cancer.~   "
269740|NCT00004031|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of~     chemotherapy and radiation and kill more cancer cells. It is not yet known whether~     chemoradiotherapy plus peripheral stem cell transplantation is more effective than~     combination chemotherapy alone in treating non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is studying chemoradiotherapy and peripheral stem~     cell transplantation to see how well they work compared to combination chemotherapy in~     treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.~   "
269741|NCT00004028|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are~     undergoing surgery for recurrent malignant glioma.~   "
269742|NCT00004024|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Combining different types of biological therapies may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery~     and radiation therapy in treating patients who have primary or recurrent astrocytoma or~     oligodendroglioma.~   "
269743|NCT00004017|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver~     tumor-killing substances to them without harming normal cells. This may be an effective~     treatment for some types of brain tumors.~      PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in~     treating patients who have glioblastoma multiforme or anaplastic astrocytoma.~   "
269744|NCT00004015|"~     RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming~     normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron~     capture therapy following surgery in treating patients with glioblastoma multiforme removed~     during surgery.~   "
269745|NCT00004011|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known if surgery plus combination chemotherapy is more effective than surgery alone for~     non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without~     combination chemotherapy in treating patients who have non-small cell lung cancer.~   "
269746|NCT00004005|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work~     in different ways to stop tumor cells from dividing so they stop growing or die. Radiation~     therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy~     drug with radiation therapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with radiation therapy works in treating patients with stage III or stage IV colorectal~     carcinoma (cancer), other refractory carcinoma (cancer), or metastatic adenocarcinoma~     (cancer) of unknown primary origin.~   "
269747|NCT00004001|"~     RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Combining more than one drug and giving~     drugs in different ways may kill more tumor cells. It is not yet known whether estramustine~     plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of estramustine plus~     docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV~     prostate cancer that has not responded to hormone therapy.~   "
269748|NCT00003994|"~     Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they~     stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective~     drugs such as amifostine may protect normal cells from the side effects of chemotherapy. It~     is not yet known which chemotherapy regimen is most effective for children and young adults~     with liver cancer. This randomized phase III trial is studying giving combination~     chemotherapy together with amifostine to see how well it works compared to combination~     chemotherapy alone in treating patients with liver cancer.~   "
269749|NCT00003993|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill~     cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 when~     given together with bryostatin 1 in treating patients with refractory solid tumors or~     lymphoma.~   "
269750|NCT00003981|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have~     solid tumors.~   "
269751|NCT00003979|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have~     solid tumors.~   "
269752|NCT00003977|"~     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients~     with recurrent or persistent cervical cancer that cannot be treated with surgery or radiation~     therapy.~   "
269753|NCT00003970|"~     Phase I trial to study genetic testing and the effectiveness of irinotecan in treating~     patients who have solid tumors and lymphoma. Drugs used in chemotherapy use different ways to~     stop cancer cells from dividing so they stop growing or die. Genetic testing for a specific~     enzyme may help doctors determine whether side effects from or response to chemotherapy are~     related to a person's genetic makeup~   "
269755|NCT00003966|"~     RATIONALE: Giving defibrotide may be an effective treatment for liver damage that may result~     following peripheral stem cell transplantation.~      PURPOSE: This randomized phase II trial is studying defibrotide to see how well it works in~     treating patients with severe liver disease after undergoing peripheral stem cell~     transplantation.~   "
269756|NCT00003963|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die. Combining~     monoclonal antibody therapy with chemotherapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab plus~     chemotherapy with vinorelbine in treating patients with B-cell non-Hodgkin's lymphoma that~     has relapsed following autologous peripheral stem cell transplantation.~   "
269757|NCT00003961|"~     RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of~     immune cells found in bone marrow or peripheral blood.~      PURPOSE: Phase II trial to study the effectiveness of sargramostim after bone marrow~     transplantation in treating patients who have myelodysplastic syndrome.~   "
269758|NCT00003958|"~     This randomized phase III trial is comparing two different combination chemotherapy regimens~     to see how well each works in treating patients with previously untreated rhabdomyosarcoma or~     sarcoma. Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and~     topotecan, use different ways to stop tumor cells from dividing so they stop growing or die.~     It is not yet known which combination chemotherapy regimen is more effective in treating~     rhabdomyosarcoma.~   "
269759|NCT00003955|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with~     radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.~   "
269760|NCT00003945|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which chemotherapy regimen is more effective for cervical cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of three different~     chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical~     cancer.~   "
269761|NCT00003941|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~     Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy and~     kill more cancer cells. It is not yet known whether chemotherapy and peripheral stem cell~     transplant is more effective than chemotherapy alone.~      PURPOSE: This randomized phase III trial is studying how well combination chemotherapy works~     when given with peripheral stem cell transplant and how it compares with combination~     chemotherapy alone in treating men with previously untreated germ cell cancer.~   "
269762|NCT00003938|"~     RATIONALE: Liposomal amphotericin B may be effective in controlling fever and~     granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more~     effective in treating cancer patients who have these conditions.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal~     amphotericin B in treating granulocytopenia and fever in cancer patients.~   "
269763|NCT00003934|"~     This randomized phase III trial is studying tretinoin and combination chemotherapy to see how~     well they work compared to tretinoin, combination chemotherapy, and arsenic trioxide in~     treating patients with acute promyelocytic leukemia that has not been treated previously.~     Drugs used in chemotherapy, such as daunorubicin, cytarabine, mercaptopurine, methotrexate,~     and arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop~     growing or die. Tretinoin may help leukemia cells develop into normal white blood cells. It~     is not yet known which regimen is more effective for acute promyelocytic leukemia.~   "
269764|NCT00003928|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: This phase II trial is studying how well gemcitabine and cisplatin work in treating~     patients with metastatic kidney cancer.~   "
269765|NCT00003915|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Androgens can stimulate the growth of prostate cancer cells.~     Hormone therapy using bicalutamide and leuprolide may fight prostate cancer by reducing the~     production of androgens.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy consisting of docetaxel~     and estramustine plus hormone therapy in treating patients who have previously undergone~     radiation therapy or surgical removal of the prostate for stage I prostate cancer.~   "
269766|NCT00003913|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Umbilical cord blood transplantation may be able to replace~     immune cells that were destroyed by the chemotherapy or radiation therapy that was used to~     kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation~     plus combination chemotherapy in treating patients who have hematologic cancer or~     nonmalignant hematologic disease.~   "
269767|NCT00003912|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known which chemotherapy regimen is more effective in~     treating children with liver cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of cisplatin with or without~     doxorubicin and the effectiveness of combining cisplatin, carboplatin, and doxorubicin in~     treating children who have liver cancer.~   "
269768|NCT00003910|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of methotrexate with or without~     cyclophosphamide in treating patients who have lymphocytic leukemia with neutropenia or~     anemia.~   "
269769|NCT00003909|"~     Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin~     gadolinium may make the tumor cells more sensitive to radiation therapy. Phase I trial to~     study the effectiveness of motexafin gadolinium plus radiation therapy in treating children~     who have newly diagnosed brain stem glioma~   "
269770|NCT00003906|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the~     tumor cells.~      PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene~     with that of tamoxifen in preventing breast cancer in postmenopausal women.~   "
269771|NCT00003903|"~     RATIONALE: Assessing the effect of androgen suppression on bone loss in prostate cancer~     patients may improve the ability to plan treatment, may decrease the risk of fractures and~     bony pain, and may help patients live more comfortably.~      PURPOSE: Clinical trial to determine the effect of androgen suppression on bone loss in~     patients who have prostate cancer.~   "
269772|NCT00003902|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine and~     vinorelbine and to see how well they work in treating older women with metastatic breast~     cancer with or without bone involvement.~   "
269773|NCT00003901|"~     RATIONALE: Prognostic testing for early signs of metastases may help doctors detect~     metastases early and plan more effective treatment.~      PURPOSE: Phase III trial to study the relationship between early signs of metastases and~     survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that~     can be removed by surgery.~   "
269774|NCT00003896|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and~     liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian~     cancer, fallopian tube cancer, or primary peritoneal cancer.~   "
269775|NCT00003893|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumors cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is~     not yet known which regimen of chemotherapy plus radiation therapy is more effective for~     early-stage breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of~     adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast~     cancer.~   "
269776|NCT00003878|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving the drugs in different ways may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating~     patients who have brain metastases and who are undergoing surgery to remove the tumor.~   "
269777|NCT00003875|"~     This phase II trial studies the side effects and how well giving busulfan and etoposide~     followed by peripheral blood stem cell transplant (PBSCT) and low-dose aldesleukin works in~     treating patients with acute myeloid leukemia (AML). Drugs used in chemotherapy, such as~     busulfan and etoposide, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. A PBSCT may be able to replace~     blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to~     be given so that more cancer cells are killed. Aldesleukin may stimulate the white blood~     cells to kill cancer cells. Giving busulfan and etoposide together followed by PBSCT and~     aldesleukin may be an effective treatment for AML.~   "
269778|NCT00003869|"~     Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating~     patients who have stage III or stage IV non-small cell lung cancer. Chemotherapeutic agents~     are modestly effective for the treatment of advanced lung cancer, with rapid tumor relapse~     and growth even after initial response to therapy. It is not yet known whether~     carboxyamidotriazole is more effective than no further treatment after standard chemotherapy~     for non-small cell lung cancer.~   "
269779|NCT00003865|"~     RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using~     toremifene may fight ovarian cancer by reducing the production of estrogen.~      PURPOSE: Randomized phase II trial to study the effectiveness of toremifene in treating~     patients who have recurrent or refractory ovarian cancer.~   "
269780|NCT00003863|"~     RATIONALE: Determination of genetic markers for aggressive non-Hodgkin's lymphoma may help~     identify patients with this disease and help predict the outcome of treatment.~      PURPOSE: Diagnostic study to determine the genetic markers in patients who have aggressive~     non-Hodgkin's lymphoma.~   "
269781|NCT00003862|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in~     treating patients who have stomach cancer.~   "
269782|NCT00003861|"~     This research trial studies molecular genetic features in blood and tissue samples from~     patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia.~     Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute~     promyelocytic leukemia in the laboratory may help doctors identify and learn more about~     biomarkers related to cancer.~   "
269783|NCT00003857|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can~     stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast~     cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if~     radiation therapy is more effective than observation, with or without tamoxifen, in treating~     ductal carcinoma in situ.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with~     that of observation, with or without tamoxifen, in treating women who have ductal carcinoma~     in situ.~   "
269784|NCT00003855|"~     RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have~     spread from tumors in the breast.~      PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in~     the armpit in treating women who have stage I or stage IIA breast cancer.~   "
269785|NCT00003854|"~     RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect~     and determine the extent of cancer.~      PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow~     metastases in women who have stage I or stage IIA breast cancer.~   "
269786|NCT00003851|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Pancreatic enzymes may help kill cancer cells. It is not yet known~     if gemcitabine is more effective than pancreatic enzyme therapy plus specialized diet for~     pancreatic cancer.~      PURPOSE: This clinical trial is comparing the effectiveness of gemcitabine with that of~     pancreatic enzyme therapy plus specialized diet (Gonzalez regimen) in treating patients who~     have stage II, stage III, or stage IV pancreatic cancer.~   "
269787|NCT00003843|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who~     have colorectal cancer.~   "
269788|NCT00003838|"~     The are a variety of cancerous diseases of the blood and bone marrow that can be potentially~     cured by bone marrow transplantation (BMT). Diseases like leukemia, lymphoma, and multiple~     myeloma are among the conditions that can be treated with BMT.~      Some patients with these diseases can be treated with medical chemotherapy alone. However,~     patients who relapse following chemotherapy are usually not curable with additional~     chemotherapy treatments. The only option known to provide a potential cure if this occurs is~     BMT.~      Allogenic transplants are cells collected from relatives of the patient. The transplant~     requires additional high intensity chemotherapy and radiation in order to destroy cancerous~     cells. In the process, many normal bone marrow cells are also destroyed. This is the reason~     for transplanting stem cells. The stem cells help to build new functioning bone marrow, red~     cells, white cells, and platelets. In addition, the immune cells from the donor are implanted~     into the recipient s body and help to fight off infection and kill remaining cancerous cells.~      Unfortunately, the powerful doses of chemotherapy and radiation therapy associated with~     allogenic BMT have toxic side effects and often make BMTs too dangerous to attempt in many~     patients.~      In order to reduce the complications of BMT, and make it a safer available option for~     patients with cancers of the blood and bone marrow, researchers have developed a new approach~     to the BMT.~      In this study researchers plan to use stem cells collected from the blood stream of patient s~     relatives rather than from the bone marrow (blood progenitor/stem cell transplant). In~     addition, researchers plan to use low doses of chemotherapy and no radiation therapy to~     reduce side effects. The majority of the cancer killing effect will be the responsibility of~     the stem cell transplant rather than the chemotherapy.~   "
269789|NCT00003837|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die.~      PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have~     relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.~   "
269790|NCT00003833|"~     RATIONALE: Genetic studies may help in understanding the genetic processes that cause some~     types of cancer.~      PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III~     colon cancer.~   "
269791|NCT00003831|"~     RATIONALE: Surgical removal of all lymph nodes in the chest may kill cancer cells that have~     spread from tumors in the lung. It is not yet known whether complete removal of all lymph~     nodes in the chest is more effective than removal of selected lymph nodes in treating~     patients who have stage I or stage II non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of complete removal of all~     lymph nodes in the chest with that of selected removal of lymph nodes during lung cancer~     surgery in treating patients who have stage I or stage II non-small cell lung cancer.~   "
269792|NCT00003820|"~     Phase 2 trial to study the effectiveness of rituximab in treating patients who have~     lymphocyte-predominant Hodgkin's lymphoma.~   "
269793|NCT00003816|"~     RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor stem cell~     helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune~     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are~     infused into the patient they may help the patient's bone marrow make stem cells, red blood~     cells, white blood cells, and platelets. It is not yet known which combination chemotherapy~     regimen is most effective when given before a donor stem cell transplant in treating aplastic~     anemia or hematologic cancer.~      PURPOSE: This phase II/III trial is studying different combination chemotherapy regimens to~     compare how well they work when given before donor stem cell transplant in treating patients~     with aplastic anemia or hematologic cancer.~   "
269794|NCT00003815|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy~     drugs and kill more cancer cells.~      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and radiation~     therapy plus bone marrow transplantation in treating patients who have aggressive~     non-Hodgkin's lymphoma.~   "
269795|NCT00003803|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy used high-energy x-rays to damage tumor cells. It~     is not yet know whether chemotherapy followed by radiation therapy is more effective than~     chemotherapy given with radiation therapy for non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of~     chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage~     II, or stage III non-small cell lung cancer.~   "
269796|NCT00003800|"~     RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of~     testicular cancer.~      PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage~     I testicular cancer and who have undergone orchiectomy within the previous 12 weeks.~   "
269797|NCT00003799|"~     Phase I trial to study the effectiveness of radiation therapy plus chemotherapy followed by~     surgery and additional chemotherapy in treating patients who have advanced nonmetastatic~     primary cancer of the rectum. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to~     damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be an~     effective treatment for rectal cancer~   "
269798|NCT00003796|"~     Phase II trial to study the effectiveness of irofulven in treating patients who have~     metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die.~   "
269799|NCT00003793|"~     RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may~     help doctors identify patients who are at risk for therapy-related leukemia.~      PURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or~     rhabdomyosarcoma to identify children who are at risk of developing leukemia from the~     chemotherapy used to treat sarcoma.~   "
269814|NCT00003732|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin~     and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.~   "
269800|NCT00003789|"~     Randomized phase III trial to compare the effectiveness of hyperthermic isolated limb~     perfusion of melphalan with or without tumor necrosis factor in treating patients who have~     locally advanced melanoma of the arm or leg. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die. Heating melphalan to several~     degrees above body temperature and infusing it only to the area around the tumor may kill~     more tumor cells. It is not yet known whether combining melphalan with tumor necrosis factor~     is more effective than melphalan alone in treating melanoma.~   "
269801|NCT00003788|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to~     combined therapy with surgery, radiation therapy, and chemotherapy is more effective than~     combined therapy alone for supratentorial gliomas.~      PURPOSE: Randomized phase III trial to study the effectiveness of surgery, radiation therapy,~     and chemotherapy with or without photodynamic therapy in treating patients who have newly~     diagnosed or recurrent malignant supratentorial gliomas.~   "
269802|NCT00003782|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor~     cells remaining following surgery. It is not yet known which regimen of combination~     chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     combination chemotherapy in treating women who have undergone surgery for stage I, stage II,~     or stage IIIA breast cancer with positive axillary lymph nodes.~   "
269803|NCT00003771|"~     RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It~     is not yet known if hormone replacement therapy increases the risk of breast cancer~     recurrence in women previously treated for early stage breast cancer.~      PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in~     women with previous early stage breast cancer who are receiving hormone replacement therapy~     for menopause symptoms.~   "
269804|NCT00003764|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known whether combining cyclophosphamide with fludarabine is more effective than~     fludarabine alone in treating chronic lymphocytic leukemia.~      PURPOSE: Randomized phase III trial to study the effectiveness of fludarabine with or without~     cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been~     treated previously.~   "
269805|NCT00003753|"~     RATIONALE: Drugs used in chemotherapy, such as floxuridine, dexamethasone, and irinotecan,~     use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic~     arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining~     more than one drug and giving them in different ways may kill any tumor cells remaining after~     surgery.~      PURPOSE: Phase II trial to study the effectiveness of irinotecan combined with hepatic~     arterial infusion with floxuridine and dexamethasone after surgery in treating patients who~     have liver metastases from colorectal cancer.~   "
269806|NCT00003750|"~     RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein use different~     ways to stimulate the immune system and stop cancer cells from growing.~      PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in~     treating children who have refractory or recurrent neuroblastoma or other tumors.~   "
269807|NCT00003749|"~     RATIONALE: Lymphadenectomy may remove cancer cells that have spread to nearby lymph nodes.~     Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether~     conventional surgery is more effective with or without lymphadenectomy and/or radiation~     therapy in treating endometrial cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with~     or without lymphadenectomy and/or radiation therapy in treating patients who have endometrial~     cancer.~   "
269808|NCT00003746|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if giving cladribine once a day is more~     effective than giving cladribine once a week in patients with hairy cell leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of cladribine given once a~     day to cladribine given once a week in treating patients with hairy cell leukemia.~   "
269809|NCT00003745|"~     Phase II trial to study the effectiveness of topotecan in treating children who have~     recurrent, relapsed, or refractory sarcoma. Drugs used in chemotherapy use different ways to~     stop tumor cells from dividing so they stop growing or die.~   "
269810|NCT00003744|"~     The purpose of this study is to see how patients with incurable salivary gland cancer, who~     have not had chemotherapy before, respond to Gemcitabine. The investigators are trying to~     find out what effects (good and bad) Gemcitabine has on participants and salivary gland~     cancer.~      Gemcitabine has been shown to be an effective chemotherapy agent in other types of cancer,~     including; bladder cancer, breast cancer, certain types of lung cancer, ovarian cancer, and~     pancreas cancer. Gemcitabine has yet to be studied for efficacy in subjects with salivary~     gland cancer and in general other chemotherapy drugs have shown to be ineffective so far in~     this population.~   "
269811|NCT00003741|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.~   "
269812|NCT00003739|"~     RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by~     chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune~     cells found in bone marrow or peripheral blood and may help a person's immune system recover~     from the side effects of chemotherapy. It is not yet known whether antibiotic therapy plus~     G-CSF is more effective than antibiotic therapy alone for treating side effects caused by~     chemotherapy.~      PURPOSE: Randomized phase III trial to compare the effectiveness of antibiotic therapy with~     or without G-CSF in treating children who have neutropenia and fever that are caused by~     chemotherapy.~   "
269813|NCT00003737|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating~     children who have relapsed or refractory neuroblastoma.~   "
269815|NCT00003730|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized clinical trial to study the effectiveness of vinorelbine plus~     fluorouracil in treating women who have metastatic breast cancer that has been previously~     treated with at least one regimen of chemotherapy.~   "
269816|NCT00003728|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of combination chemotherapy plus steroid therapy is more effective~     for acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of~     combination chemotherapy plus steroid therapy in treating children who have acute~     lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.~   "
269817|NCT00003727|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with a peripheral stem cell transplant~     and immunotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill~     more cancer cells. Biological therapies use different ways to stimulate the immune system and~     stop cancer cells from growing.~      PURPOSE: This phase II trial is studying giving chemotherapy together with a peripheral stem~     cell transplant followed by immunotherapy to see how well it works in treating patients with~     chronic phase chronic myelogenous leukemia.~   "
269818|NCT00003702|"~     Randomized phase III trial to compare the effectiveness of methotrexate with that of~     dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether methotrexate is more effective than dactinomycin in treating~     patients with gestational trophoblastic neoplasia.~   "
269819|NCT00003696|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is most effective for extensive-stage small~     cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination~     chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.~   "
269820|NCT00003690|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of flavopiridol plus cisplatin or~     carboplatin in treating patients who have advanced solid tumors.~   "
269821|NCT00003688|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of dactinomycin in treating patients who~     have persistent or recurrent gestational trophoblastic neoplasia.~   "
269822|NCT00003687|"~     RATIONALE: Different drug formulations and combinations of drugs may help patients with~     chronic pain live more comfortably. It is not yet known which regimen is most effective for~     chronic pain.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different morphine~     formulations with or without dextromethorphan in treating chronic pain in patients who have~     advanced cancer.~   "
269823|NCT00003678|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of~     tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast~     cancer that has been surgically removed.~   "
269824|NCT00003659|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~     Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing~     substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose~     cyclophosphamide and rituximab in treating patients who have previously untreated chronic~     lymphocytic leukemia.~   "
269825|NCT00003658|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate tumor cells~     and either kill them or deliver tumor-killing substances to them without harming normal~     cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combining pentostatin,~     cyclophosphamide, and rituximab in treating patients who have chronic lymphocytic leukemia or~     other B-cell cancers that have been treated previously.~   "
269826|NCT00003656|"~     RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa~     may interfere with the growth of cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon~     alfa in treating patients who have metastatic kidney cancer.~   "
269827|NCT00003653|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy may~     fight prostate cancer by reducing the production of androgens. It is not yet known which~     androgen suppression regimen is more effective for prostate cancer.~      PURPOSE: This randomized phase III trial is studying two hormone therapy regimens and~     comparing them to see how well they work in treating patients with rising PSA levels~     following radiation therapy for prostate cancer.~   "
269828|NCT00003652|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: This randomized phase III trial is studying different regimens of giving combination~     chemotherapy together with radiation therapy and comparing how well they work in treating~     patients with stage II or stage III anal cancer.~   "
269829|NCT00003650|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating~     children who have non-Hodgkin's lymphoma.~   "
269830|NCT00003644|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose~     paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian~     cancer.~      PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see~     how well they work compared to carboplatin and paclitaxel together with continued low-dose~     paclitaxel in treating patients with early-stage ovarian cancer.~   "
269831|NCT00003643|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of combination chemotherapy may be more effective for germ cell~     cancer.~      PURPOSE: This randomized phase II/III trial is studying two different regimens of combination~     chemotherapy and comparing how well they work in treating men with germ cell cancer.~   "
269832|NCT00003641|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known~     whether treatment with interferon alfa is more effective than observation alone for stage II~     or stage III melanoma that has been completely removed surgically.~      PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how~     well it works compared to observation only in treating patients with stage II or stage III~     melanoma that has been completely removed by surgery.~   "
269833|NCT00003637|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether radiation therapy alone is more effective than radiation~     therapy plus chemotherapy in treating cancer of the nasopharynx.~      PURPOSE: This randomized phase III trial is studying how well radiation therapy and~     chemotherapy works compared to radiation therapy alone in treating patients with previously~     untreated cancer of the nasopharynx.~   "
269834|NCT00003636|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It~     is not yet known whether chemotherapy before surgery is more effective than chemotherapy~     after surgery in treating ovarian, peritoneal, or fallopian tube cancer.~      PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see~     how well it works compared to chemotherapy given after surgery with or without additional~     surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or~     fallopian tube cancer.~   "
269835|NCT00003633|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of combination~     chemotherapy in treating patients with advanced prostate cancer.~   "
269836|NCT00003631|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells. Peripheral stem cell~     transplantation may be able to replace immune cells that were destroyed by chemotherapy and~     radiation therapy used to kill tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in~     treating patients with refractory or relapsed Hodgkin's lymphoma.~   "
269837|NCT00003613|"~     This phase I trial is studying the side effects and best dose of carmustine given together~     with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell~     lymphoma that has not responded to previous treatment. Drugs used in chemotherapy use~     different ways to stop cancer cells from dividing so they stop growing or die. Combining more~     than one drug may kill more cancer cells~   "
269838|NCT00003612|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal~     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and~     trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.~   "
269839|NCT00003611|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of acitretin may be an effective way to prevent~     the recurrence or further development of skin cancer.~      PURPOSE: Randomized clinical trial to study the effectiveness of acitretin in preventing skin~     cancers in patients with at least two previously treated skin cancers who have undergone~     organ transplantation.~   "
269840|NCT00003607|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known whether radiation therapy to the prostate and pelvis is more effective than radiation~     therapy to the prostate alone in treating prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the~     prostate with or without radiation to the pelvis in treating patients with stage I, stage II,~     or stage III prostate cancer.~   "
269841|NCT00003603|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~     Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of~     chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more~     effective in treating patients with multiple myeloma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of~     chemotherapy plus steroid therapy in treating patients with multiple myeloma that has~     recurred for the first time.~   "
269842|NCT00003602|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which combination chemotherapy regimen is more effective in treating older~     patients with acute myeloid leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination~     chemotherapy regimens in treating older patients with acute myeloid leukemia in first~     remission.~   "
270947|NCT00040495|"~     The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole~     in the prevention of rebleeding in patients with bleeding peptic ulcer disease after~     successful endoscopic hemostatic therapy.~   "
269843|NCT00003596|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug or combining radiation therapy with~     chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and~     mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus~     radiation therapy for anal cancer.~      PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus~     radiation therapy to see how well it works compared to fluorouracil and cisplatin plus~     radiation therapy in treating patients with stage II or stage III anal cancer.~   "
269844|NCT00003593|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating~     children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia,~     or myelodysplastic syndrome.~   "
269845|NCT00003590|"~     RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with~     unresectable benign meningioma.~   "
269846|NCT00003577|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known whether combination chemotherapy plus epirubicin is more effective than combination~     chemotherapy alone for stage I or stage II breast cancer.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see~     how well it works compared to combination chemotherapy and epirubicin in treating women with~     stage I or stage II breast cancer who have undergone surgery to remove the tumor.~   "
269847|NCT00003576|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether surgery plus radiation therapy is more effective than~     chemotherapy plus radiation therapy for head and neck cancer.~      PURPOSE: This randomized phase III trial is studying surgery and radiation therapy to see how~     well they work compared to chemotherapy and radiation therapy in treating patients with stage~     III or stage IV head and neck cancer that can be removed during surgery.~   "
269848|NCT00003569|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Chemoprotective drugs such as dimesna may protect normal cells from~     the side effects of chemotherapy.~      PURPOSE: This phase I trial is studying the side effects and best dose of dimesna in treating~     patients with solid tumors who are receiving cisplatin and paclitaxel.~   "
269849|NCT00003568|"~     RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells.~     Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.~      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with~     interleukin-2 in treating patients with metastatic melanoma.~   "
269850|NCT00003567|"~     RATIONALE: Gene therapy may improve the body's ability to fight cancer or make the cancer~     more sensitive to chemotherapy. Drugs used in chemotherapy use different ways to stop tumor~     cells from dividing so they stop growing or die.~      PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy~     together with chemotherapy in treating patients with advanced solid tumors or non-Hodgkin's~     lymphoma.~   "
269851|NCT00003566|"~     RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's~     response to previous treatment.~      PURPOSE: Diagnostic trial to determine the accuracy of thoracoscopy in patients who have~     stage IIIA non-small cell lung cancer.~   "
269852|NCT00003565|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to compare the effectiveness of docetaxel in treating Caucasian and~     African American patients who have solid tumors.~   "
269853|NCT00003560|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in~     treating patients who have stage III or stage IV ovarian cancer, fallopian tube cancer, or~     primary peritoneal cancer.~   "
269854|NCT00003558|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is more effective for cancer of unknown~     primary origin.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of~     combination chemotherapy in treating patients with cancer of unknown primary origin.~   "
269855|NCT00003553|"~     RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before~     a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It may~     also stop the patient's immune system from rejecting the donor's stem cells. The donated stem~     cells may replace the patient's immune cells and help destroy any remaining tumor cells~     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte~     infusion) after the transplant may help increase this effect. Sometimes the transplanted~     cells from a donor can also make an immune response against the body's normal cells. Giving~     cyclosporine with or without mycophenolate mofetil or methotrexate after the transplant may~     stop this from happening.~      PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in~     treating patients with metastatic kidney cancer.~   "
269856|NCT00003538|"~     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were~     destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the~     transplanted cells can make an immune response against the body's normal tissues. Stem cells~     that have been treated in the laboratory to remove lymphocytes may prevent this from~     happening.~      PURPOSE: Clinical trial to prevent graft-versus-host disease in patients undergoing bone~     marrow transplantation.~   "
269857|NCT00003537|"~     RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit~     to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may~     prove beneficial in the treatment of adults with anaplastic astrocytoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults with anaplastic astrocytoma.~   "
269858|NCT00003536|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Antineoplastons are naturally occurring substances that may also be~     made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. It is not yet~     known whether giving antineoplastons with chemotherapy is more effective than chemotherapy~     alone in treating women with refractory breast cancer.~      PURPOSE: This randomized phase II trial is studying methotrexate alone to see how well it~     works campared to methotrexate and antineoplaston therapy in treating postmenopausal women~     with advanced refractory breast cancer.~   "
269859|NCT00003535|"~     RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas~     provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston~     therapy suggest that it may prove beneficial in the treatment of children with~     recurrent/progressive high grade gliomas.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on children (> 6 months of age) with recurrent/progressive high~     grade gliomas.~   "
269860|NCT00003534|"~     Current therapies for Refractory Stage IV Prostate Cancer provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Refractory Stage IV Prostate Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Refractory Stage IV Prostate Cancer.~   "
269861|NCT00003533|"~     Current therapies for Metastatic Pancreatic Cancer provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Metastatic Pancreatic Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Metastatic Pancreatic Cancer.~   "
269862|NCT00003532|"~     Current therapies for Stage III or IV Ovarian Cancer provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Stage III or IV Ovarian Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage III or IV Ovarian Cancer.~   "
269863|NCT00003531|"~     Current therapies for Stage IV Pancreatic Cancer provide very limited benefit to the patient.~     The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in~     the treatment of Stage IV Pancreatic Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV Pancreatic Cancer.~   "
269864|NCT00003530|"~     Current therapies for Primary Liver Cancer provide very limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of Primary Liver Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with advanced Head and Neck Cancer.~   "
269865|NCT00003526|"~     Current therapies for Cancer of Unknown Primary Origin provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Cancer of Unknown Primary Origin.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Cancer of Unknown Primary Origin.~   "
269866|NCT00003525|"~     Current therapies for Stage IV Cancer of the Cervix and/or Vulva provide very limited benefit~     to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may~     prove beneficial in the treatment of Stage IV Cancer of the Cervix and/or Vulva.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV Cancer of the Cervix and/or Vulva.~   "
269867|NCT00003524|"~     Current therapies for Stomach Cancer provide very limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of Stomach Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stomach Cancer.~   "
269868|NCT00003522|"~     Current therapies for Cancer of the Small Intestine provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Cancer of the Small Intestine.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Cancer of the Small Intestine.~   "
269869|NCT00003521|"~     Current therapies for Soft Tissue Sarcoma provide very limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of Soft Tissue Sarcoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Soft Tissue Sarcoma.~   "
269870|NCT00003520|"~     Current therapies for Stage IV Kidney Cancer provide very limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of Stage IV Kidney Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV Kidney Cancer.~   "
269871|NCT00003517|"~     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the~     laboratory. Antineoplastons may inhibit the growth of cancer cells.~      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating~     patients with stage III or stage IV prostate cancer.~   "
269872|NCT00003516|"~     Current therapies for Stage III or Stage IV Prostate Cancer provide very limited benefit to~     the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Stage III or Stage IV Prostate Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage III or Stage IV Prostate Cancer.~   "
269873|NCT00003515|"~     Current therapies for Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors~     provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston~     therapy suggest that it may prove beneficial in the treatment of Metastatic, Recurrent, or~     Refractory Primitive Neuroectodermal Tumors.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Metastatic, Recurrent, or Refractory Primitive~     Neuroectodermal Tumors.~   "
269874|NCT00003514|"~     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the~     laboratory. Antineoplastons may inhibit the growth of cancer cells.~      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating~     patients with neuroendocrine tumor that is metastatic or unlikely to respond to surgery or~     radiation therapy.~   "
269875|NCT00003513|"~     Current therapies for Metastatic, Recurrent, or Refractory Neuroblastoma provide very limited~     benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it~     may prove beneficial in the treatment of Metastatic, Recurrent, or Refractory Neuroblastoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Metastatic, Recurrent, or Refractory~     Neuroblastoma.~   "
269876|NCT00003512|"~     Current therapies for Recurrent or Refractory Waldenstrom's Macroglobulinemia provide very~     limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest~     that it may prove beneficial in the treatment of Recurrent or Refractory Waldenstrom's~     Macroglobulinemia.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Recurrent or Refractory Waldenstrom's~     Macroglobulinemia.~   "
269877|NCT00003511|"~     Current therapies for Multiple Myeloma provide limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of Multiple Myeloma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Multiple Myeloma.~   "
269878|NCT00003509|"~     Current therapies for Stage IV Melanoma provide very limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of Stage IV Melanoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV Melanoma.~   "
269879|NCT00003508|"~     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the~     laboratory. Antineoplastons may inhibit the growth of cancer cells.~      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating~     patients with advanced mesothelioma.~   "
269880|NCT00003505|"~     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the~     laboratory. Antineoplastons may inhibit the growth of cancer cells.~      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating~     patients with primary central nervous system lymphoma.~   "
269881|NCT00003502|"~     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the~     laboratory. Antineoplastons may inhibit the growth of cancer cells.~      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating~     patients with stage II, stage III, or stage IV mantle cell lymphoma.~   "
269882|NCT00003501|"~     Current therapies for Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma~     provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston~     therapy suggest that it may prove beneficial in the treatment of Refractory or Recurrent~     High-Grade Stage II - IV Non-Hodgkin's Lymphoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Refractory or Recurrent High-Grade Stage II - IV~     Non-Hodgkin's Lymphoma.~   "
269883|NCT00003500|"~     Current therapies for Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's~     Lymphoma provide very limited benefit to the patient. The anti-cancer properties of~     Antineoplaston therapy suggest that it may prove beneficial in the treatment of Refractory or~     Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Refractory or Recurrent Intermediate-Grade Stage~     II - IV Non-Hodgkin's Lymphoma.~   "
269884|NCT00003499|"~     Current therapies for Low-grade Non-Hodgkin's Lymphoma provide limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Low-grade Non-Hodgkin's Lymphoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Low-grade Non-Hodgkin's Lymphoma.~   "
269885|NCT00003498|"~     Current therapies for Non-Hodgkin's Lymphoma provide limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of Non-Hodgkin's Lymphoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Non-Hodgkin's Lymphoma.~   "
269886|NCT00003497|"~     Current therapies for Stage IV non-small cell lung cancer provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Stage IV lung cancer~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV lung cancer.~   "
269887|NCT00003496|"~     Current therapies for Recurrent or Extensive-Stage Small Cell Lung Cancer provide very~     limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest~     that it may prove beneficial in the treatment of Recurrent or Extensive-Stage Small Cell Lung~     Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Recurrent or Extensive-Stage Small Cell Lung~     Cancer.~   "
269888|NCT00003495|"~     Current therapies for Stage IV or Recurrent Lung Cancer provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Stage IV or Recurrent Lung Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV or Recurrent Lung Cancer.~   "
269889|NCT00003494|"~     Current therapies for Recurrent or Stage IV Lung Cancer provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Recurrent or Stage IV Lung Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Recurrent or Stage IV Lung Cancer.~   "
269890|NCT00003492|"~     Current therapies for Stage IV Lung Cancer provide very limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of Stage IV Pancreatic Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV Lung Cancer.~   "
269891|NCT00003491|"~     Current therapies for Stage IV lung cancer provide very limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of Stage IV lung cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV lung cancer.~   "
269892|NCT00003489|"~     Current therapies for advanced Head and Neck Cancer provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of advanced Head and Neck Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with advanced Head and Neck Cancer.~   "
269893|NCT00003487|"~     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the~     laboratory. Antineoplastons may inhibit the growth of cancer cells.~      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating~     patients with cancer of the esophagus.~   "
269894|NCT00003486|"~     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the~     laboratory. Antineoplastons may inhibit the growth of cancer cells.~      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating~     patients with colon cancer.~   "
269895|NCT00003485|"~     Current therapies for metastatic or unresectable Colon Cancer provide very limited benefit to~     the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of metastatic or unresectable Colon Cancer.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with metastatic or unresectable Colon Cancer~   "
269896|NCT00003483|"~     RATIONALE: Current therapies for adults with meningioma provide limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of adults with meningioma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults with meningioma.~   "
269897|NCT00003479|"~     RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of patients with ependymoma .~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with ependymoma.~   "
269898|NCT00003478|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing~     substances such as radioactive iodine to them without harming normal cells.~      PURPOSE: This randomized phase I/II trial is studying the side effects, best way to give, and~     best dose of radiolabeled monoclonal antibody and to see how well it works in treating~     patients with primary brain tumors.~   "
269899|NCT00003477|"~     RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable~     to or have not responded to standard therapy, provide limited benefit to the patient. The~     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the~     treatment of children with visual pathway gliomas, which are not amenable to or have not~     responded to standard therapy.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to~     or have not responded to standard therapy.~   "
269900|NCT00003476|"~     RATIONALE: Current therapies for children with primary malignant brain tumors provide limited~     benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it~     may prove beneficial in the treatment of children with primary malignant brain tumors.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on children with primary malignant brain tumors.~   "
269901|NCT00003475|"~     RATIONALE: Current therapies for adults with primary malignant brain tumors that have not~     responded to standard therapy provide very limited benefit to the patient. The anti-cancer~     properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of~     adults with primary malignant brain tumors that have not responded to standard therapy.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults with primary malignant brain tumors that have not~     responded to standard therapy.~   "
269902|NCT00003474|"~     RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of brain tumors.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive~     Glioblastoma Multiforme.~   "
269903|NCT00003473|"~     RATIONALE: Current therapies for adults with recurrent or refractory mixed gliomas provide~     very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy~     suggest that it may prove beneficial in the treatment of adults with recurrent or refractory~     mixed gliomas.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.~   "
269904|NCT00003472|"~     RATIONALE: Current therapies for adult recurrent/progressive oligodendrogliomas provide very~     limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest~     that it may prove beneficial in the treatment of childhood brain tumors.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adult recurrent/progressive oligodendrogliomas.~   "
269905|NCT00003471|"~     RATIONALE: Current therapies for adult recurrent/progressive low grade astrocytoma provide~     limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest~     that it may prove beneficial in the treatment of adult recurrent/progressive low grade~     astrocytoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults with a recurrent/progressive low grade astrocytoma.~   "
269906|NCT00003470|"~     RATIONALE: Current therapies for adults with anaplastic astrocytomas that have not responded~     to standard therapy provide very limited benefit to the patient. The anti-cancer properties~     of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults~     with anaplastic astrocytomas that have not responded to standard therapy.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults with anaplastic astrocytomas that have not responded to~     standard therapy.~   "
269907|NCT00003469|"~     RATIONALE: Current therapies for childhood Rhabdoid tumors provide limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of childhood Rhabdoid tumors.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on children (> 6 months of age) with Rhabdoid tumors.~   "
269908|NCT00003468|"~     RATIONALE: Current therapies for children with low grade astrocytomas that have not responded~     to standard therapy provide limited benefit to the patient. The anti-cancer properties of~     Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with~     low grade astrocytomas that have not responded to standard therapy~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on children (> 6 months of age) with low grade astrocytomas that~     has not responded to standard therapy.~   "
269909|NCT00003467|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with~     recurrent supratentorial low-grade glioma.~   "
269910|NCT00003466|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients~     with progressive low-grade glioma.~   "
269911|NCT00003462|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving drugs into the thin space between the lining of the spinal~     cord and brain may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of intrathecal busulfan in treating~     patients with recurrent, refractory, or metastatic leptomeningeal tumors.~   "
269912|NCT00003461|"~     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive~     tumor-killing substances to them without harming normal cells. This may be effective~     treatment for primary or metastatic brain tumors.~      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy~     in treating patients with primary or metastatic brain tumors.~   "
269913|NCT00003460|"~     RATIONALE: Current therapies for children with primitive neuroectodermal tumors that have not~     responded to standard therapy provide very limited benefit to the patient. The anti-cancer~     properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of~     children with primitive neuroectodermal tumors that have not responded to standard therapy.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on children (> 6 months of age) with primitive neuroectodermal~     tumors that has not responded to standard therapy.~   "
269914|NCT00003459|"~     RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of brain stem gliomas.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on children (> 6 months of age) and adults with newly-diagnosed or~     recurrent brain stem gliomas.~   "
269915|NCT00003458|"~     RATIONALE: Current therapies for childhood brain tumors provide limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of childhood brain tumors.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on children (> 6 months of age) with brain tumors.~   "
269916|NCT00003457|"~     RATIONALE: Current therapies for adults with persistent or recurrent brain tumors provide~     very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy~     suggest that it may prove beneficial in the treatment of adults with persistent or recurrent~     brain tumors.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults with persistent or recurrent brain tumors.~   "
269917|NCT00003456|"~     RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of brain tumors.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed Glioblastoma~     Multiforme.~   "
269918|NCT00003455|"~     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the~     laboratory. Antineoplastons may inhibit the growth of cancer cells.~      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating~     women with stage IV breast cancer that has not responded to standard therapy.~   "
269919|NCT00003454|"~     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the~     laboratory. Antineoplastons may inhibit the growth of cancer cells.~      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating~     women who have stage IV breast cancer that has not responded to previous therapy.~   "
269920|NCT00003453|"~     Current therapies for Stage IV adrenal gland cancer provide very limited benefit to the~     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove~     beneficial in the treatment of Stage IV adrenal gland cancer~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV adrenal gland cancer.~   "
269921|NCT00003452|"~     Current therapies for Stage IV bladder cancer provide very limited benefit to the patient.~     The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in~     the treatment of Stage IV bladder cancer~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on patients with Stage IV bladder cancer.~   "
269922|NCT00003440|"~     This randomized phase III studies how well two different regimens of paclitaxel with or~     without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that~     is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use~     different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal~     antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. It is not yet known what~     regimen of paclitaxel is more effective with or without trastuzumab in treating patients with~     breast cancer.~   "
269923|NCT00003437|"~     RATIONALE: Hormone therapy may stop the growth of cancer cells. Drugs used in chemotherapy~     use different ways to stop cancer cells from dividing so they stop growing or die. Combining~     hormone therapy with chemotherapy may kill more cancer cells. It is not yet known which~     hormone therapy and chemotherapy regimen is most effective for acute lymphoblastic leukemia.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different steroid therapy~     and chemotherapy regimens in treating children who have acute lymphoblastic leukemia.~   "
269924|NCT00003429|"~     RATIONALE: New imaging procedures such as fludeoxyglucose F 18 PET scan may improve the~     ability to detect cancer or recurrence of cancer.~      PURPOSE: Clinical trial to study the effectiveness of fludeoxyglucose F 18 PET scan in~     diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery.~   "
269925|NCT00003422|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether giving radiation therapy before surgery is more effective~     than giving chemotherapy plus radiation therapy after surgery in treating patients with~     rectal cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy given before surgery~     to see how well it works compared to chemotherapy and radiation therapy given after surgery~     in treating patients with rectal cancer that can be surgically removed.~   "
269926|NCT00003420|"~     RATIONALE: Imaging procedures such as CT scans help the doctor in detecting cancer or the~     recurrence of cancer. Increasing the number of times a CT scan is given may improve the~     ability to detect stage I testicular cancer.~      PURPOSE: Randomized clinical trial to determine if there is a different result from two~     different schedules of CT scans in treating patients with stage I testicular cancer after~     undergoing orchiectomy.~   "
269927|NCT00003419|"~     RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may~     have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may~     be an effective treatment for Kaposi's sarcoma.~      PURPOSE: This phase II trial is studying how well antiviral therapy works in treating~     patients with slowly progressing HIV-related Kaposi's sarcoma.~   "
269928|NCT00003417|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems~     that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment~     may result in more effective radiation therapy. Drugs used in chemotherapy use different ways~     to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy~     with chemotherapy may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy that has been~     planned with a computer plus chemotherapy in treating patients who have glioblastoma~     multiforme.~   "
269929|NCT00003404|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy~     following surgery may be effective in treating patients with phyllodes tumor of the breast.~      PURPOSE: This phase II trial is studying how well radiation therapy works after surgery in~     treating women with phyllodes tumor of the breast.~   "
269930|NCT00003389|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is~     not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's~     lymphoma.~      PURPOSE: This randomized phase III trial is studying two different combination chemotherapy~     regimens and comparing how well they work, with or without radiation therapy, in treating~     patients with Hodgkin's lymphoma.~   "
269931|NCT00003385|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of~     liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated~     ovarian, peritoneal, or fallopian tube cancer.~   "
269932|NCT00003384|"~     This diagnostic trial is studying the presence of a specific protein as a potential biomarker~     of cervical dysplasia and/or cancer. The presence of specific proteins may allow a doctor to~     determine whether a patient has cervical dysplasia and/or cancer.~   "
269933|NCT00003379|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and~     cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more~     sensitive to radiation. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may~     kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy to the pelvis plus~     paclitaxel and cisplatin in treating patients who have cervical cancer.~   "
269934|NCT00003377|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and~     cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more~     sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when~     given with radiation therapy and cisplatin and to see how well they work in treating patients~     with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.~   "
269964|NCT00003140|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by reducing the production of estrogen.~      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in~     treating women with breast cancer who have received tamoxifen for at least 5 years.~   "
269935|NCT00003375|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether radiation therapy combined with chemotherapy is more~     effective than radiation therapy alone in treating patients with low-grade glioma.~      PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of~     radiation therapy with or without combination chemotherapy in treating patients with~     low-grade glioma.~   "
269936|NCT00003354|"~     RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal~     cancer and may have fewer side effects and improve recovery. It is not yet known if~     undergoing conventional surgery is more effective than laparoscopic-assisted surgery for~     colorectal cancer.~      PURPOSE: This randomized phase III trial is studying conventional surgery to see how well it~     works compared to laparoscopic-assisted surgery in treating patients with colorectal cancer.~   "
269937|NCT00003342|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of giving gemcitabine, doxorubicin,~     and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney~     cancer and impaired kidney function.~   "
269938|NCT00003336|"~     RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of~     chemotherapy or radiation therapy and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well umbilical cord blood transplantation works~     in treating patients with severe aplastic anemia, malignant thymoma, or myelodysplasia.~   "
269939|NCT00003335|"~     RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of~     chemotherapy or radiation therapy and kill more cancer cells.~      PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to~     see how well it works when given with chemotherapy or radiation therapy in treating patients~     with high-risk hematologic cancer.~   "
269940|NCT00003332|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug with radiation therapy and/or surgery~     may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy, consisting~     of gemcitabine and cisplatin, followed by chemotherapy and radiation therapy and/or surgery~     in treating patients who have pancreatic cancer.~   "
269941|NCT00003329|"~     RATIONALE: Identification of genes that may be associated with developing certain types of~     cancer may someday provide important information about a person's risk of getting cancer.~      PURPOSE: This clinical trial is studying to see if certain genes may be associated with~     cancer in patients with cancer of the breast, prostate, lung, or colon and siblings of these~     patients.~   "
269942|NCT00003325|"~     RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva.~      PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating~     patients with stage I or stage II cancer of the vulva.~   "
269943|NCT00003309|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining more than one drug and combining chemotherapy with radiation therapy may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     radiation therapy in treating adult patients with brain cancer.~   "
269944|NCT00003308|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients~     with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.~   "
269945|NCT00003292|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase II trial to study the effectiveness of ifosfamide in treating patients with~     meningeal tumors that have recurred or that cannot be removed surgically.~   "
269946|NCT00003291|"~     RATIONALE: The identification of gene mutations may allow doctors to better determine the~     prognosis of children with acute lymphoblastic leukemia.~      PURPOSE: This clinical trial is studying gene mutations to see if they are related to~     prognosis of cancer in children with acute lymphoblastic leukemia.~   "
269947|NCT00003282|"~     Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may~     help to plan effective treatment for solid tumors. This phase I trial is studying how well~     EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors~     that can be biopsied or removed by surgery~   "
269948|NCT00003278|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Combining~     radiation therapy with a corticosteroid, such as dexamethasone, may be an effective treatment~     for non-Hodgkin's lymphoma.~      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and high-dose~     dexamethasone in treating older patients with primary CNS non-Hodgkin's lymphoma.~   "
269949|NCT00003273|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of different regimens of combination~     chemotherapy followed by peripheral stem cell transplantation in treating children who have~     newly diagnosed brain tumor.~   "
269950|NCT00003268|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~     Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of~     chemotherapy.~      PURPOSE: Phase I trial to study the effectiveness of amifostine in treating patients with~     newly diagnosed acute myeloid leukemia who are receiving idarubicin plus cytarabine.~   "
269951|NCT00003261|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together~     with radiation therapy works in treating patients with HIV-related primary central nervous~     system lymphoma.~   "
269952|NCT00003243|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. White~     blood cells from donors may be able to kill cancer cells in patients who have hematologic~     cancer that has recurred following bone marrow transplantation.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus infusion~     of donated white blood cells in treating patients who have hematologic cancer that has~     recurred after bone marrow transplantation.~   "
269953|NCT00003216|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known~     which treatment regimen is most effective for pancreatic cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and~     gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have~     undergone surgery.~   "
269954|NCT00003215|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining peripheral stem cell transplantation with more than one~     drug regimen may kill more tumor cells. It is not known whether receiving standard~     combination chemotherapy alone is more effective than receiving multiple combination~     chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma.~      PURPOSE: This randomized phase III trial is comparing giving different combination~     chemotherapy regimens together with peripheral stem cell transplantation to see how well they~     work in treating patients with newly diagnosed aggressive non-Hodgkin's lymphoma.~   "
269955|NCT00003204|"~     Randomized phase III trial to compare the effectiveness of two regimens of combination~     chemotherapy followed by rituximab or observation in treating patients who have stage III or~     stage IV low-grade non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to~     stop cancer cells from dividing so they stop growing or die. Combining more than one drug may~     kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and~     either kill them or deliver cancer-killing substances to them without harming normal cells.~     It is not yet known which regimen of combination chemotherapy, with or without rituximab, is~     more effective for non-Hodgkin's lymphoma~   "
269956|NCT00003199|"~     This phase II trial studies how well giving combination chemotherapy and peripheral blood~     stem cell transplant followed by aldesleukin and sargramostim works in treating patients with~     inflammatory stage IIIB or metastatic stage IV breast cancer. Drugs used in chemotherapy,~     such as busulfan, melphalan, and thiotepa, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell~     transplant may be able to replace blood-forming cells that were destroyed by chemotherapy.~     This may allow more chemotherapy to be given so that more tumor cells are killed. Aldesleukin~     may stimulate the white blood cells to kill breast cancer cells. Giving aldesleukin together~     with sargramostim may kill more tumor cells~   "
269957|NCT00003194|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and peripheral~     stem cell transplantation in treating patients who have recurrent or refractory solid tumors.~   "
269958|NCT00003179|"~     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the~     development or recurrence of cancer. The use of surgery with or without medroxyprogesterone~     may be an effective way to prevent the development of endometrial cancer in patients who have~     endometrial hyperplasia.~      PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of~     medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have~     endometrial hyperplasia.~   "
269959|NCT00003178|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of idarubicin and cladribine in treating~     children who have recurrent acute myeloid leukemia.~   "
269960|NCT00003174|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of cladribine when~     given with bryostatin 1 in treating patients with relapsed chronic lymphocytic leukemia.~   "
269961|NCT00003159|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if surgery is more effective with or without~     preoperative chemotherapy in treating non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to~     see how well they work compared to surgery alone in treating patients with resectable~     non-small cell lung cancer.~   "
269962|NCT00003153|"~     RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with~     multiple myeloma that has recurred following bone marrow transplantation.~      PURPOSE: This phase II trial is studying how well giving donor white blood cells works in~     treating patients with recurrent multiple myeloma who have undergone bone marrow~     transplantation.~   "
269963|NCT00003145|"~     This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and~     peripheral blood stem cell transplant followed by donor lymphocyte infusion in treating older~     patients with chronic myeloid leukemia. Giving chemotherapy and total-body irradiation before~     a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving cyclosporine~     and mycophenolate mofetil after the transplant may stop this from happening. Once the donated~     stem cells begin working, the patient's immune system may see the remaining cancer cells as~     not belonging in the patient's body and destroy them (called graft-versus-tumor effect).~     Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost~     this effect.~   "
269965|NCT00003138|"~     RATIONALE: Erythropoietin and colony-stimulating factors such as filgrastim stimulate the~     production of blood cells. It is not yet known whether erythropoietin with or without~     filgrastim is more effective than standard blood transfusions in reducing the need for~     transfusions in patients who have anemia associated with myelodysplastic syndrome.~      PURPOSE: Randomized phase III trial to compare the effectiveness of erythropoietin with or~     without filgrastim with that of standard blood transfusions in reducing the need for~     transfusions in patients who have anemia associated with myelodysplastic syndrome.~   "
269966|NCT00003135|"~     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above~     body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from~     dividing so they stop growing or die. Combining chemotherapy with hyperthermia may kill more~     tumor cells.~      PURPOSE: This phase II trial is studying how well giving fluorouracil and liposomal~     doxorubicin together with systemic hyperthermia works in treating patients with metastatic~     breast, ovarian, endometrial, or cervical cancer.~   "
269967|NCT00003128|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether ifosfamide alone is more effective than~     ifosfamide plus paclitaxel in treating patients with cancer of the uterus.~      PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with or~     without paclitaxel in treating patients with advanced, refractory, or recurrent cancer of the~     uterus.~   "
269968|NCT00003122|"~     RATIONALE: Surgery may be an effective treatment for neuroblastoma.~      PURPOSE: This phase II trial is studying how well surgery works in treating patients with~     neuroblastoma.~   "
269969|NCT00003119|"~     RATIONALE: Surgery alone may be effective in treating children with neuroblastoma.~      PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who~     have neuroblastoma.~   "
269970|NCT00003116|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving busulfan, cyclophosphamide, and~     filgrastim together with peripheral stem cell transplantation from a sibling donor works in~     treating patients with hematologic cancer.~   "
269971|NCT00003111|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with~     irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small~     cell lung cancer.~   "
269972|NCT00003105|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating~     patients with metastatic or locally advanced bladder cancer.~   "
269973|NCT00003104|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Computer systems~     that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment~     may result in more effective radiation therapy.~      PURPOSE: This phase II trial is studying how well radiation therapy that has been planned~     with a computer works in treating patients with prostate cancer.~   "
269974|NCT00003096|"~     RATIONALE: Analyzing the number and structure of genes found in a child's cancer cells may~     help doctors improve methods of diagnosing and treating children with brain tumors.~      PURPOSE: This clinical trial is studying the number and structure of genes in cancer cells of~     children with brain tumors.~   "
269975|NCT00003093|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. Combination~     chemotherapy plus surgery may be an effective treatment for neuroblastoma.~      PURPOSE: This phase III trial is studying how well combination chemotherapy followed by~     surgery works in treating young patients with neuroblastoma.~   "
269976|NCT00003092|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients~     who have solid tumors.~   "
269977|NCT00003067|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill~     cancer cells in patients with primary or advanced glioma.~      PURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2~     and lymphokine-activated killer cells in treating patients who have primary, recurrent, or~     refractory malignant glioma.~   "
269978|NCT00003065|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating~     patients who have recurrent or metastatic cancer of the cervix.~   "
269979|NCT00003063|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop~     cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor~     cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using~     levamisole with treatment using interferon alfa and combination chemotherapy consisting of~     fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.~   "
269980|NCT00003053|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy~     in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer~     that has been surgically removed.~   "
269996|NCT00002982|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give~     higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with peripheral stem cell transplantation works in treating older patients with refractory or~     relapsed intermediate-grade non-Hodgkin's lymphoma.~   "
269981|NCT00003052|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several~     degrees above body temperature. It is not known whether receiving chemotherapy plus~     hyperthermia is more effective than receiving chemotherapy alone in treating patients with~     soft tissue sarcoma.~      PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see~     how well it works compared to combination chemotherapy and hyperthermia therapy in treating~     patients with soft tissue sarcoma.~   "
269982|NCT00003049|"~     RATIONALE: Surgery to remove the pancreas, some of the small intestine, and lymph nodes may~     be more effective treatment for cancer of the pancreas than surgery to remove the pancreas~     and some of the small intestine alone. Radiation therapy uses high-energy x-rays to damage~     tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die. Combining surgery, radiation therapy, and chemotherapy may be an~     effective treatment for cancer of the pancreas.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the~     pancreas and a portion of the small intestine with or without removing lymph nodes, followed~     by radiation therapy and chemotherapy, in treating patients with cancer of the pancreas.~   "
269983|NCT00003042|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation~     work in treating patients with stage IIIB breast cancer.~   "
269984|NCT00003034|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin~     is more effective than doxorubicin alone in treating patients with malignant mesothelioma.~      PURPOSE: This randomized phase III trial is studying doxorubicin alone to see how well it~     works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.~   "
269985|NCT00003029|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving drugs in different ways may~     kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more~     effective than fluorouracil alone in treating patients with metastatic cancer of the~     pancreas.~      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or~     without cisplatin in treating patients who have advanced or metastatic cancer of the~     pancreas.~   "
269986|NCT00003027|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill~     melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet~     known whether combination chemotherapy plus interleukin-2 and interferon alfa is more~     effective than combination chemotherapy alone for metastatic melanoma.~      PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without~     interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that~     cannot be treated by surgery.~   "
269987|NCT00003026|"~     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using~     triptorelin may fight prostate cancer by reducing the production of androgens.~      PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy~     and triptorelin with no further treatment in treating patients who have advanced prostate~     cancer previously treated with radiation therapy and 6 months of androgen suppression.~   "
269988|NCT00003023|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Combining monoclonal antibody~     A1G4 with BCG may kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in~     treating patients with cancer.~   "
269989|NCT00003022|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells.~      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating~     patients who have leptomeningeal metastases.~   "
269990|NCT00003016|"~     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using~     tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known~     if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative~     treatment for breast cancer.~      PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period~     of time to see how well it works compared to giving tamoxifen over a shorter period of time~     in treating patients who have had a breast tumor removed.~   "
269991|NCT00003013|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It~     is not yet known which treatment regimen is more effective for breast cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy plus surgery~     in treating women who have breast cancer.~   "
269992|NCT00002996|"~     RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.~      PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with~     chronic neuropathic pain from cancer or AIDS.~   "
269993|NCT00002995|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage~     tumor cells. It is not yet known whether chemotherapy is more effective with or without~     radiation therapy in treating patients who have rhabdomyosarcoma.~      PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without~     radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.~   "
269994|NCT00002990|"~     RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system~     and stop cancer cells from growing.~      PURPOSE: This randomized phase III trial is studying four different regimens of BCG and~     comparing how well they work in treating patients who have undergone surgery for bladder~     cancer.~   "
269995|NCT00002986|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients~     with recurrent primary malignant glioma.~   "
269998|NCT00002976|"~     RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women~     with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect~     cancer recurrence.~      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen~     replacement therapy in treating women who have stage I or stage II endometrial cancer.~   "
269999|NCT00002975|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in~     treating patients with skin cancer.~      PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that~     includes aminolevulinic acid works in treating patients with skin cancer.~   "
270000|NCT00002968|"~     Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal~     antibody therapy in treating patients who have stage II colon cancer. Monoclonal antibodies~     such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing~     substances to them without harming normal cells. It is not yet known whether surgery to~     remove colon cancer is more effect with or without monoclonal antibody therapy.~   "
270001|NCT00002963|"~     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to~     light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be~     effective in treating patients with skin cancer.~      PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in~     treating patients with skin cancer.~   "
270002|NCT00002951|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining radiation therapy with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in~     treating patients with head and neck cancer.~   "
270003|NCT00002948|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of drugs and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of high-dose topotecan and peripheral stem~     cell transplantation in treating patients with refractory cancer.~   "
270004|NCT00002944|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: This randomized phase III trial is studying two different combination chemotherapy~     regimens and comparing how well they work in treating children with low-grade astrocytomas or~     other residual tumors of the brain.~   "
270005|NCT00002943|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation~     may help the body kill more tumor cells.~      PURPOSE: Phase II trial to study the effects of high doses of carboplatin, etoposide, and~     cyclophosphamide followed by autologous bone marrow transplantation in patients with relapsed~     or refractory germ cell cancer and other chemotherapy-sensitive solid tumors.~   "
270006|NCT00002941|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give~     higher doses of chemotherapy and kill more cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     peripheral stem cell transplantation in treating children who have recurrent or refractory~     Hodgkin's lymphoma or non-Hodgkin's lymphoma.~   "
270007|NCT00002938|"~     RATIONALE: Prostatectomy may be an effective treatment for prostate cancer that has not~     responded to radiation therapy.~      PURPOSE: This phase II trial is studying how well prostatectomy works in treating patients~     with recurrent or persistent prostate cancer that has not responded to radiation therapy.~   "
270008|NCT00002931|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together~     with bone marrow transplantation or peripheral stem cell transplantation works in treating~     patients with relapsed germ cell cancer.~   "
270009|NCT00002926|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation~     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell~     transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome~     or acute myelogenous leukemia.~   "
270010|NCT00002920|"~     RATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing~     endometrial disorder in patients with breast cancer who are taking tamoxifen.~      PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in~     preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ,~     lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II~     breast cancer and who are taking tamoxifen.~   "
270011|NCT00002916|"~     RATIONALE: Vaccines made from human papillomavirus may make the body build an immune response~     to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a more~     effective treatment for cervical cancer.~      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with~     surgery works in treating patients with early cervical cancer.~   "
270012|NCT00002913|"~     Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or~     without filgrastim in treating patients who have newly diagnosed stage III or stage IV~     epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells~     from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may~     increase the number of immune cells found in bone marrow or peripheral blood and may help a~     person's immune system recover from the side effects of chemotherapy~   "
270401|NCT00001422|"~     This is a placebo controlled study evaluating the role of fludarabine (a nucleoside analog~     targeting both resting and proliferating lymphocytes) in the treatment of moderate to severe~     psoriotic arthritis. Patients should have failed at least one disease modifying antirheumatic~     drug.~   "
270013|NCT00002900|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die.~      PURPOSE: This clinical trial is studying the effect of chemotherapy on heart function in~     treating women who have breast cancer with negative axillary lymph nodes and who are~     undergoing treatment on the SWOG-8897 clinical trial.~   "
270014|NCT00002899|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant~     radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for~     brain metastases.~      PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how~     well it works compared to surgery or radiosurgery and whole-brain radiation therapy in~     treating brain metastases in patients with solid tumors.~   "
270015|NCT00002898|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one chemotherapy drug with surgery and/or~     radiation therapy may kill more tumor cells.~      PURPOSE: This randomized phase III trial is studying surgery followed by different regimens~     of combination chemotherapy given together with radiation therapy and/or additional surgery~     to compare how well they work in treating patients with soft tissue sarcoma.~   "
270016|NCT00002895|"~     RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube,~     or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125~     become elevated rather than waiting for other indicators of disease recurrence.~      PURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels~     of CA 125 alone to see how well it works compared to chemotherapy based on conventional~     clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary~     peritoneal cancer.~   "
270017|NCT00002894|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of platinum-based~     chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial~     cancer.~   "
270018|NCT00002883|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not known whether combining chemotherapy with surgery is more~     effective than surgery alone.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without~     combination chemotherapy in treating patients with cancer of the esophagus.~   "
270019|NCT00002882|"~     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may~     stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether~     interferon alfa plus combination chemotherapy and interleukin-2 is more effective than~     interferon alfa alone in treating patients with melanoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or~     without combination chemotherapy plus interleukin-2 in treating patients with melanoma.~   "
270020|NCT00002874|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can~     stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight~     prostate cancer by reducing the production of androgens. It is not yet known if radiation~     therapy is more effective with or without bicalutamide for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without bicalutamide in treating patients who have stage II or stage III prostate cancer and~     elevated prostate-specific antigen (PSA) levels following radical prostatectomy.~   "
270021|NCT00002860|"~     RATIONALE: Surgery may be effective therapy in treating patients with metastatic melanoma.~      PURPOSE: This phase II trial is studying how well surgery works in treating patients with~     metastatic melanoma.~   "
270022|NCT00002855|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining hormone therapy with chemotherapy and androgen~     suppression may kill more tumor cells. It is not yet known which treatment regimen is more~     effective for prostate cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone~     therapy versus androgen suppression alone as initial therapy in patients with prostate cancer~     that is metastatic or that cannot be removed surgically.~   "
270023|NCT00002854|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give~     higher doses of chemotherapy drugs and kill more tumor cells.~      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral~     stem cell transplantation in treating patients who have advanced cancer.~   "
270024|NCT00002852|"~     Randomized phase III trial to compare the effectiveness of surgery with or without~     combination chemotherapy in treating patients who have stage I non-small cell lung cancer.~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining more than one drug may kill more tumor cells. It is not yet known~     whether surgery is more effective with or without chemotherapy for non-small cell lung~     cancer.~   "
270025|NCT00002851|"~     RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared to no further therapy in treating women with stage I, stage II, or stage III~     breast cancer that has been surgically removed.~   "
270026|NCT00002850|"~     RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection~     in patients with multiple myeloma and may improve their response to chemotherapy.~      PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work~     compared to no antibiotics in preventing early infection in patients with multiple myeloma.~   "
270027|NCT00002849|"~     RATIONALE: Chemotherapy plus interferon alfa may be effective for primary systemic~     amyloidosis.~      PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in~     treating patients who have primary systemic amyloidosis.~   "
270028|NCT00002848|"~     RATIONALE: Developing coping strategies may help improve the quality of life of patients with~     prostate cancer.~      PURPOSE: This randomized clinical trial is comparing the effect of group therapy with written~     educational materials on the quality of life of men with stage I or stage II prostate cancer.~   "
270029|NCT00002847|"~     RATIONALE: Biological therapies use different ways to stimulate the immune system to try to~     stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in~     treating patients with metastatic kidney cancer.~   "
270030|NCT00002846|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer~     cells.~      PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating~     patients with metastatic or recurrent kidney cancer.~   "
270031|NCT00002842|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug and giving drugs in different ways may~     kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus~     systemic fluorouracil and leucovorin in treating patients with liver metastases from~     colorectal cancer.~   "
270032|NCT00002839|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to~     preserve the part of the body where the cancer started. It is not yet known which regimen of~     cisplatin and fluorouracil combined with radiation therapy is more effective in treating~     resectable cancer of the hypopharynx or larynx.~      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin~     and fluorouracil combined with radiation therapy in preserving the larynx in patients who~     have resectable cancer of the hypopharynx or larynx.~   "
270033|NCT00002810|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma~     cells, either by killing the cells or by stopping them from dividing. Having a peripheral~     stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows~     higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing~     the number of plasma cells, the disease may progress more slowly.~      PURPOSE: This phase II trial is studying how well giving high-dose melphalan together with~     peripheral stem cell transplant works in treating patients with primary amyloidosis or~     amyloidosis associated with multiple myeloma.~   "
270034|NCT00002809|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer~     cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an~     unrelated donor together with cyclophosphamide and total-body irradiation works in treating~     patients with hematologic cancer.~   "
270035|NCT00002807|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet~     known whether radiation therapy is more effective than observation only after sugery in~     treating endometrial cancer.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared to observation only in treating patients with stage I or stage II endometrial~     cancer who have undergone hysterectomy and oophorectomy.~   "
270036|NCT00002798|"~     Randomized phase III trial to compare the effectiveness of different chemotherapy regimens~     with or without bone marrow transplantation in treating children who have acute myelogenous~     leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop~     cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone~     marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and~     kill more cancer cells. It is not yet known which treatment regimen is more effective for~     acute myelogenous leukemia or myelodysplastic syndrome~   "
270037|NCT00002796|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Interferon-gamma may interfere with the growth of tumor cells and slow the~     growth of the tumor. Combining more than one drug with interferon-gamma may kill more tumor~     cells. This phase I/II trial is studying the side effects and best dose of giving~     fluorouracil together with phenylbutyrate, indomethacin, and interferon-gamma and to see how~     well it works in treating patients with stage IV colorectal cancer~   "
270038|NCT00002792|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with~     chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either~     bone marrow or peripheral stem cell transplantation in treating patients with~     myeloproliferative disorders.~   "
270039|NCT00002778|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Combining chemotherapy with allogeneic bone marrow~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     cancer cells. Colony-stimulating factors such as sargramostim may increase the number of~     immune cells found in bone marrow or peripheral blood, and may help a person's immune system~     recover from the side effects of chemotherapy.~      PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation~     followed by sargramostim in treating patients who have chronic myelogenous leukemia.~   "
270040|NCT00002771|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may~     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of various combination~     chemotherapy regimens or bone marrow transplantation in treating patients with chronic~     myelogenous leukemia.~   "
270041|NCT00002766|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic~     leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.~      PURPOSE: This randomized phase III trial is studying two different chemotherapy regimens and~     comparing them to see how well they work in treating adults with acute lymphoblastic~     leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.~   "
270042|NCT00002762|"~     RATIONALE: Timing of breast cancer surgery may improve effectiveness of treatment and may~     help patients live longer.~      PURPOSE: Clinical trial to determine whether timing of primary surgery in relation to~     menstrual cycle is associated with disease-free survival 5 years after surgery in women who~     have stage I or stage II breast cancer.~   "
270043|NCT00002757|"~     RATIONALE: Less intensive therapy may attain in the same results as intensive therapy in~     children with non-Hodgkin's lymphoma.~      PURPOSE: Randomized phase III trial to study the effectiveness of less intensive therapy for~     children who have non-Hodgkin's lymphoma.~   "
270044|NCT00002756|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Combining more than one chemotherapy drug and giving~     them as induction intensification may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well induction intensification works in treating~     infants with newly diagnosed acute lymphocytic leukemia.~   "
270045|NCT00002746|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients with~     myelodysplastic syndrome.~   "
270046|NCT00002738|"~     RATIONALE: Drugs used in chemotherapy, such as trimetrexate glucuronate and leucovorin, use~     different ways to stop cancer cells from dividing so they stop growing or die. Combining more~     than one drug may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     children with recurrent acute lymphoblastic leukemia, recurrent osteosarcoma, or refractory~     non-Hodgkin's lymphoma.~   "
270047|NCT00002727|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet~     known which radiation therapy regimen is more effective in treating patients with stage II~     cancer of the vocal cord.~      PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating~     patients who have stage II cancer of the vocal cord.~   "
270048|NCT00002720|"~     RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women~     with breast cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without~     axillary lymph node dissection following quadrantectomy in treating older women with stage I~     breast cancer that is estrogen receptor positive.~   "
270049|NCT00002718|"~     RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune~     cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF~     stimulated peripheral stem cell transplantation in treating patients with leukemia,~     lymphoblastic lymphoma, myelodysplastic syndrome, or aplastic anemia.~   "
270050|NCT00002716|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more cancer cells. It is not~     yet known which chemotherapy regimen is more effective for metastatic colorectal cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine,~     leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin in treating~     patients who have unresectable liver metastases from colorectal cancer.~   "
270051|NCT00002715|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating~     patients who have advanced Hodgkin's lymphoma.~   "
270052|NCT00002706|"~     This randomized phase III trial is studying laparoscopic surgery to see how well it works~     compared to standard surgery in treating patients with endometrial cancer or cancer of the~     uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and~     may have fewer side effects and improve recovery. It is not known whether laparoscopic~     surgery is more effective than standard surgery in treating endometrial cancer.~   "
270053|NCT00002702|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells of~     the mouth or oropharynx. Radiation therapy uses high-energy x-rays to damage tumor cells. It~     is not known whether giving interleukin-2 with surgery and radiation therapy is more~     effective than surgery and radiation therapy alone.~      PURPOSE: This randomized phase III trial is studying surgery and radiation therapy alone to~     see how well they work compared to surgery, radiation therapy, and interleukin-2 in treating~     patients with cancer of the mouth or oropharynx.~   "
270054|NCT00002700|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor~     cells. Bone marrow transplantation can replace immune cells that were destroyed by~     chemotherapy.~      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with~     or without bone marrow transplantation in treating patients with acute lymphoblastic~     leukemia.~   "
270055|NCT00002697|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with radiation therapy and peripheral stem~     cell transplantation may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy plus~     radiation therapy followed by peripheral stem cell transplantation in patients with~     refractory or recurrent non-Hodgkin's lymphoma.~   "
270056|NCT00002696|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and~     fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with~     stage III breast cancer.~   "
270057|NCT00002689|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Radiation therapy combined with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam~     radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that~     cannot be removed surgically.~   "
270058|NCT00002687|"~     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.~      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who~     have mycosis fungoides.~   "
270059|NCT00002684|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, use~     different ways to stop tumor cells from dividing so they stop growing or die. Combining more~     than one drug and giving drugs in different ways may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating~     patients with metastatic urinary tract cancer that cannot be treated with surgery.~   "
270060|NCT00002681|"~     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver~     cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a~     person's white blood cells to kill leukemia or lymphoma cells. Combining these two therapies~     may be an effective treatment for leukemia and lymphoma.~      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy plus~     interleukin-2 in treating patients who have leukemia or lymphoma.~   "
270061|NCT00002678|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     yet known which combination chemotherapy regimen is most effective in treating patients with~     multiple myeloma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of various combination~     chemotherapy regimens in treating patients with multiple myeloma.~   "
270062|NCT00002668|"~     RATIONALE: An outpatient educational and behavioral skills training program may help patients~     with metastatic breast or prostate cancer live longer and more comfortably.~      PURPOSE: This randomized clinical trial studies whether an outpatient educational and~     behavioral skills training program will improve pain control in patients who have metastatic~     or recurrent breast or prostate cancer.~   "
270063|NCT00002663|"~     The purpose of this phase I/II trial is to study the side effects and best dose of biological~     therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or~     lymphoproliferative disease.~   "
270064|NCT00002662|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether paclitaxel is more effective than~     docetaxel for breast cancer.~      PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in~     treating women with stage IIIB or metastatic breast cancer.~   "
270065|NCT00002651|"~     RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy~     may be effective treatment for prostate cancer. It is not yet known which regimen of hormone~     therapy is most effective for stage IV prostate cancer.~      PURPOSE: This randomized phase III trial is studying two different regimens of hormone~     therapy and comparing how well they work in treating men with stage IV prostate cancer.~   "
270066|NCT00002649|"~     Randomized phase III trial to compare the effectiveness of interleukin-2 with that of~     observation following radiation therapy, combination chemotherapy, and peripheral stem cell~     transplantation in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.~     Interleukin-2 may stimulate a person's white blood cells to kill non-Hodgkin's lymphoma~     cells. Giving interleukin-2 after radiation therapy, chemotherapy, and peripheral stem cell~     transplantation may kill more cancer cells~   "
270067|NCT00002647|"~     RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and~     may be an effective treatment for refractory brain tumors.~      PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic~     therapy using porfimer sodium in treating patients with refractory brain tumors, including~     astrocytoma, ependymoma, and medulloblastoma.~   "
270068|NCT00002641|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known whether giving chemotherapy after surgery is~     more effective than surgery alone in treating soft tissue sarcoma.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without~     chemotherapy in treating patients who have soft tissue sarcoma.~   "
270069|NCT00002633|"~     RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may~     fight prostate cancer by reducing the production of androgens. Radiation therapy uses~     high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus~     surgery is more effective than hormone therapy plus radiation therapy for prostate cancer.~      PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how~     well it works compared to giving hormone therapy together with bilateral orchiectomy or~     radiation therapy in treating patients with stage III or stage IV prostate cancer.~   "
270070|NCT00002624|"~     RATIONALE: Video-assisted surgery followed by radiation therapy may be an effective treatment~     in patients whose poor heart and lung function make them high risk for standard surgery.~      PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery followed by~     radiation therapy in treating patients with stage I non-small cell lung cancer and poor heart~     and lung function.~   "
270071|NCT00002623|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so~     that it can be removed during surgery. Radiation therapy uses high-energy x-rays to damage~     tumor cells. It is not yet known whether chemotherapy followed by surgery with or without~     radiation therapy is more effective than chemotherapy followed by radiation therapy alone in~     treating non-small cell lung cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by~     surgery with or without radiation therapy to that of chemotherapy followed by radiation~     therapy alone in treating patients who have stage III non-small cell lung cancer.~   "
270072|NCT00002615|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not~     known whether receiving chemotherapy before surgery may be more effective than surgery alone~     in treating patients with stomach cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination~     chemotherapy with surgery alone in treating patients with stomach cancer.~   "
270073|NCT00002611|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It~     is not yet known whether combination chemotherapy alone or combination chemotherapy plus~     radiation therapy is more effective for childhood kidney cancer.~      PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or~     without radiation therapy in treating children who have kidney cancer.~   "
270074|NCT00002610|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give~     higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which~     therapy regimen is most effective for treating patients with kidney tumors.~      PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without~     radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in~     treating young patients with kidney tumors.~   "
270075|NCT00002608|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in different~     ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate~     the growth of tumor cells. Hormone therapy using tamoxifen may fight cancer by blocking the~     uptake of estrogen. Combining tamoxifen with chemotherapy may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving cisplatin and doxorubicin together~     with tamoxifen works in treating patients with solid tumors.~   "
270076|NCT00002598|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells.~     Interferon alfa may interfere with the growth of cancer cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and interferon~     alfa in treating patients with chronic myelogenous leukemia.~   "
270077|NCT00002596|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not known whether combining chemotherapy with bone marrow or~     peripheral stem cell transplantation is more effective than combination chemotherapy alone in~     treating men with germ cell tumors.~      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy~     with or without bone marrow or peripheral stem cell transplantation in treating men with~     previously untreated germ cell tumors.~   "
270078|NCT00002594|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     that they stop growing or die. bone marrow transplantation and peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     bone marrow transplantation and/or peripheral stem cell transplantation in treating patients~     who have recurrent medulloblastoma or CNS germ cell tumors.~   "
270079|NCT00002589|"~     RATIONALE: Treating a person's lymphocytes with interleukin-2 and monoclonal antibody may~     help them kill more cancer cells when they are put back in the body.~      PURPOSE: This phase II trial is studying how well lymphocyte therapy works in treating~     patients with stage III or stage IV kidney cancer.~   "
270080|NCT00002586|"~     RATIONALE: 13 Cis retinoic acid may prevent the development of cancer cells.~      PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis~     retinoic acid with or without vitamin E for chemoprevention or observation of cancer in~     persons at high risk of developing lung cancer.~   "
270081|NCT00002569|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~     Combining chemotherapy with radiation therapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or~     without chemotherapy in treating patients who have anaplastic oligodendroglioma.~   "
270082|NCT00002560|"~     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver~     tumor-killing substances to them without harming normal cells. Combining colony-stimulating~     factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for~     advanced neuroblastoma.~      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus~     sargramostim in treating patients who have advanced neuroblastoma.~   "
270083|NCT00002558|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, carboplatin, and~     etoposide work in different ways to stop the growth of tumor cells, either by killing them or~     by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant~     may allow more chemotherapy to be given so that more tumor cells are killed.~      The design of this trial is a phase I/II trial of sequential accelerated chemotherapy cycles~     with taxol/ifosfamide and carboplatin/etoposide administered with G-CSF and PBSC support.~      PURPOSE: The purpose of this study is to determine the effects of an intensive sequence of~     chemotherapy drugs in patients with metastatic germ cell cancer. All of these chemotherapy~     drugs are known to be active in this disease.~   "
270084|NCT00002556|"~     This randomized phase III clinical trial studies combination chemotherapy with high dose~     cyclophosphamide and recombinant interferon alfa-2b to see how well it works compared to~     combination chemotherapy alone in treating patients with previously untreated stage I-III~     multiple myeloma. Drugs used in chemotherapy, such as vincristine sulfate, carmustine,~     melphalan, cyclophosphamide, and prednisone, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Recombinant~     interferon alfa-2b may interfere with the growth of cancer cells. It is not yet know whether~     giving combination chemotherapy with or without alternating high-dose cyclophosphamide and~     recombinant interferon alfa-2b is more effective in treating multiple myeloma.~   "
270085|NCT00002546|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. It is not yet known whether radiation therapy is more effective than combination~     chemotherapy in treating patients with cancer of the uterus.~      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it~     works compared to combination chemotherapy in treating patients with cancer of the uterus.~   "
270086|NCT00002544|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. It is not yet known if mitoxantrone is more effective with or~     without docetaxel.~      PURPOSE: Randomized phase III trial to compare the effectiveness of mitoxantrone with or~     without docetaxel in treating women who have metastatic breast cancer with a poor prognosis.~   "
270984|NCT00039936|"~     This is a multicenter (2 sites) randomized trial evaluating three group treatment models for~     subjects with binge eating disorder. One model is a cognitive behavior treatment (CBT) group,~     one is partial self help, and one is self help only.~   "
270087|NCT00002528|"~     RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast~     cancer cells. It is not yet known if surgery to remove breast cancer is more effective with~     or without lymph node removal.~      PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or~     without removal of axillary lymph nodes in treating women who have stage I or stage IIA~     breast cancer.~   "
270088|NCT00002523|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug, giving the drugs in different ways,~     and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.~      PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with~     radiation therapy plus fluorouracil and leucovorin before surgery, with and without~     fluorouracil and leucovorin after surgery in patients with rectal cancer that can be~     surgically removed.~   "
270089|NCT00002522|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell~     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more~     tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by~     bone marrow or peripheral stem cell transplantation in treating patients with relapsed or~     refractory Hodgkin's lymphoma.~   "
270090|NCT00002521|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Bone marrow and peripheral stem cell transplantation may allow~     doctors to give high doses of chemotherapy and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with~     cyclophosphamide, etoposide and cisplatin followed by bone marrow and/or peripheral stem cell~     transplantation in patients with relapsed or refractory intermediate- or high-grade~     non-Hodgkin's lymphoma.~   "
270091|NCT00002517|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing~     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is~     not yet known which regimen of combination chemotherapy is more effective for acute myeloid~     leukemia or myelodysplastic syndrome.~      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination~     chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or~     myelodysplastic syndrome.~   "
270092|NCT00002515|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses~     of chemotherapy and kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa,~     carboplatin, and topotecan followed by bone marrow transplantation in treating patients who~     have metastatic or progressive rare cancer.~   "
270093|NCT00002514|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from~     dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous~     stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and~     kill more cancer cells. It is not yet known whether stem cell transplantation is more~     effective than standard chemotherapy in treating acute lymphoblastic leukemia.~      PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works~     compared to standard combination chemotherapy in treating patients with acute lymphoblastic~     leukemia in first remission.~   "
270094|NCT00002511|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an~     effective treatment for prostate cancer.~      PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in~     treating patients with stage III prostate cancer following radical prostatectomy.~   "
270095|NCT00002490|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in~     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or~     die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known~     whether receiving either radiation therapy, chemotherapy, or observation is more effective~     for cancer of the bladder.~      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy,~     chemotherapy, or observation following tumor surgery in treating patients who have bladder~     cancer.~   "
270096|NCT00002484|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems~     that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment~     may result in more effective radiation therapy.~      PURPOSE: Phase I trial to study the effectiveness of high-dose radiation therapy planned~     using a 3-dimensional picture of the tumor in treating patients who have stage I, stage II,~     or stage III non-small cell lung cancer.~   "
270097|NCT00002475|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from~     dividing so they stop growing or die. Vaccines made from a patient's tumor tissue may make~     the body build an immune response to kill tumor cells. Chemotherapy combined with vaccine~     therapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide with tumor~     cell vaccine in treating patients who have metastatic cancer or cancer at high risk of~     recurrence.~   "
270098|NCT00002474|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, carboplatin, and~     mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving chemotherapy with autologous bone marrow~     transplant may allow the doctor to give higher doses of chemotherapy and kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well chemotherapy and autologous bone marrow~     transplant work in treating patients with refractory or recurrent ovarian cancer.~   "
270099|NCT00002473|"~     RATIONALE: Kidney-sparing surgery is a less invasive type of surgery for kidney cancer, and~     may have fewer side effects and improve recovery. It is unknown whether kidney-sparing~     surgery is more effective than kidney removal in treating kidney cancer.~      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to completely~     remove the kidney with kidney-sparing surgery in treating patients with resectable kidney~     cancer.~   "
270100|NCT00002472|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Combining more than one drug may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of cisplatin and etoposide in treating~     patients with CNS tumors.~   "
270101|NCT00002470|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so~     they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells.~     Combining interferon alfa with chemotherapy may kill more tumor cells.~      PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus interferon alfa in~     treating patients who have advanced metastatic carcinoid tumors.~   "
270102|NCT00002455|"~     RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer~     cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in~     treating patients who have had surgery for breast cancer, colon cancer, or melanoma.~      PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as~     maintenance immunotherapy following surgery in treating patients with breast cancer, colon~     cancer, or melanoma.~   "
270103|NCT00052156|"~     This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or~     a distant organ, and who have had all of their cancer surgically removed. The purpose of this~     study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence~     of melanoma.~   "
270104|NCT00052143|"~     The purpose of this study is to define the natural history and experiences of people who are~     at risk for developing Huntington's disease but who do not know their genetic status.~   "
270105|NCT00052130|"~     This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage~     III), and who have had all of their cancer surgically removed. The purpose of this study is~     to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of~     melanoma.~   "
270106|NCT00051818|"~     The purpose of this study is to determine if stopping anti-HIV drugs for a period of time is~     safe and effective for enhancing the immune function of patients with HIV.~   "
270107|NCT00052117|"~     This is a 48 week study for HIV-infected patients who have failed several regimens including~     PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of~     the 4 groups will contain capravirine in different doses combined with Kaletra and~     nucleosides and one of the groups will be a combination of Kaletra and nucleosides without~     the capravirine.~   "
270108|NCT00052104|"~     The purpose of this study is to develop an effective, low-cost, telephone-based intervention~     to reduce anxiety, depression, and feelings of burden and stress in caregivers of patients~     with dementia. This study will also determine whether the intervention can alter the course~     of dementia.~   "
270109|NCT00052091|"~     This study will compare the effectiveness of Problem Solving Therapy and Brief Supportive~     Therapy in treating elderly patients with major depression and thought problems.~   "
270110|NCT00052078|"~     This randomized, controlled trial compared the efficacy of the medication sertraline~     (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for~     youth with anxiety disorders.~   "
270111|NCT00052065|"~     This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in~     patients with platinum refractory or resistant ovarian cancer.~   "
270112|NCT00052052|"~     Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250~     patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety~     and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up~     to 48 weeks.~   "
270113|NCT00052026|"~     The purpose of this study is to determine whether a new medicine, called carvedilol, improves~     symptoms and heart function in children who have congestive heart failure (diminished~     function of their heart muscle that pumps blood to the body). To accomplish this, we will~     give carvedilol to some patients who have diminished heart function and congestive heart~     failure and see whether symptoms and heart function are better at the end of an 8 month~     period in those who received carvedilol compared to the other patients who did not receive~     carvedilol. We will be testing 2 different doses of carvedilol compared to no additional~     medicine.~   "
270114|NCT00052039|"~     Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b~     in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210~     patients.~   "
270115|NCT00052013|"~     The purpose of this study is to determine whether PTK787/ZK 222584 is effective in treating~     hemangioblastoma of the brain and/or retina in patients with von Hippel-Lindau disease. The~     study will also assess safety and tolerability of PTK787/ZK 222584, and changes in markers of~     angiogenesis (new blood vessel growth).~   "
270116|NCT00052000|"~     This is the first study of MLN2704 administered to humans. The purpose of the study is to~     determine the highest dose of MLN2704 that can be given safely to patients with prostate~     cancer, and to identify any side effects associated with taking the drug. This study will~     also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated~     (excreted) by the body. This process is called pharmacokinetic analysis.~   "
270117|NCT00051987|"~     The purpose of this study is to evaluate how tumors in patients with colorectal carcinoma~     respond to treatment with VELCADE alone versus VELCADE given with irinotecan, and also to see~     what effects (good and bad) it has on you and your cancer.~   "
270118|NCT00051974|"~     The purpose of this study is to evaluate how tumors in patients with non-small cell lung~     cancer respond to treatment with VELCADE alone versus VELCADE given with docetaxel and also~     to see what effects (good and bad) it has on you and your cancer.~   "
270119|NCT00051948|"~     This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin~     (carboplatin) in patients with recurrent ovarian cancer.~   "
270120|NCT00051935|"~     GSD-II (also known as Pompe disease) is caused by a deficiency of a critical enzyme in the~     body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break~     down glycogen (a stored form of sugar) within specialized structures called lysosomes. In~     patients with GSD-II, an excessive amount of glycogen accumulates and is stored in various~     tissues, especially heart and skeletal muscle, which prevents their normal function. This~     study is being conducted to evaluate the safety, pharmacokinetics, pharmacodynamics and~     efficacy of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme~     replacement therapy for a pair of siblings with GSD-II. To be eligible for this study, a~     patient must have a confirmed diagnosis of GSD-II and have a sister or brother who also has a~     confirmed diagnosis of GSD-II.~   "
270985|NCT00040066|"~     The purpose of this study is to assess the development of human laboratory study model of~     cocaine relapse prevention.~   "
270127|NCT00051831|"~     HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy~     the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called~     a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced~     treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.~   "
270128|NCT00051870|"~     This two-part study will use transcranial magnetic stimulation, or TMS (see below), to~     explore how the brain forms memories. People remember only some of the events they experience~     every day, such as faces they perceive, words they read, speech they hear and interpret, and~     so forth. The events remembered are those that have been saved or formed in the brain. Part 1~     of this study involves testing materials for Part 2, the TMS experiment. Part 2 uses TMS to~     examine what parts of the brain are involved in forming memories. Information gained from~     this study may be used in developing methods of enhancing memory in both healthy people and~     in patients with memory impairments.~      Healthy right-handed volunteers between 18 and 35 years of age may be eligible for this~     study. Candidates may be screened with a medical interview and physical examination and a~     brief test of short- and long-term visual and verbal memory. Eligible volunteers may~     participate in Part 1 or Part 2 of the study, as follows:~      Part 1 - Preparation of Words and Picture Materials~      Participants look at several words or shapes that appear in random order on a computer screen~     and try to remember them as well as possible for a memory test that will be given 20 minutes~     later. Each image appears on the screen for 3/4 of a second, with 1-1/4-second intervals~     between them. For the test, words and shapes are again shown on the computer screen at the~     same timing and intervals. When the items appear, the subject presses one of three buttons as~     quickly as possible, determining if he or she has recognized the items with a high or low~     level of confidence. The entire procedure lasts up to 1 hour, with breaks in between. The~     purpose of this experiment is to find appropriate words and pictures to use as stimuli in the~     TMS study described below.~      Part 2 - TMS Experiment~      For TMS, the subject sits in a comfortable chair. An insulated wire coil is placed on the~     scalp, and brief electrical currents are passed through the coil, creating magnetic pulses~     that stimulate the brain. The pulses may cause a pulling sensation on the skin under the coil~     and twitching in muscles of the arm or leg. Electrodes are taped to the skin over some~     muscles of the hands to record the electrical activity of the muscles. Pulses are delivered~     in trains or short bursts of impulses, each lasting half a second. Participants receive 90~     trains for a total of 900 pulses. TMS is applied during the first part of the memory study,~     when the words and shapes are first presented on the computer screen, but not during the~     second presentation for memory testing. The entire procedure takes up to 2 hours, with breaks~     in between.~      Before the TMS session, participants undergo magnetic resonance imaging (MRI) to determine~     where to place the coil for TMS. For MRI, the subject lies still for up to 30 minutes at a~     time on a table that slides into the scanner, a narrow metal cylinder surrounded by a strong~     magnetic field. Earplugs are worn to muffle loud knocking sounds that occur while the scanner~     takes pictures. Subjects can communicate with the MRI staff at all times and can ask to stop~     the procedure at any time.~   "
270129|NCT00051857|"~     This study will use magnetic resonance imaging (MRI) and ultrasound images to study how~     muscles, tendons, and bones work together to cause motion. The procedure is one of several~     tools being developed to characterize normal and impaired musculoskeletal function, with the~     goal of developing improved methods of diagnosis and treatment of movement disorders.~      Healthy normal volunteers must be age 5 to unlimited, with or without joint impairment, may~     be eligible for this study. Volunteers with joint impairment may not have serious injury to~     the joint being studied, previous surgery on the joint being studied, or extreme pain at the~     joint being studied.~      MRI uses a strong magnet and radio waves to create images of the inside of the body. The~     subject lies on a long narrow couch inside a metal cylinder (the scanner) for up to 3 hours~     while the scanner gathers data. Earplugs are worn to muffle loud noises caused by electrical~     switching of radiofrequency circuits used in the scanning process. A special pad or tube may~     be placed over or around the region being scanned to improve the quality of the data. The~     subject will be asked to repeatedly move a specific joint, such as the knee, for brief~     periods, usually less than 5 minutes. The subject can communicate via intercom with the~     person performing the study at all times during the procedure, and may request to stop the~     study at any time.~   "
270130|NCT00051805|"~     One of the main causes of treatment failure in HIV infected individuals is lack of adherence~     to complicated drug regimens. The purpose of this study is to evaluate the effectiveness of a~     behavioral intervention program designed to improve adherence to anti-HIV drug regimens.~     Participants in this study will be recruited from the University of Alabama at Birmingham~     (UAB) Outpatient HIV Clinic.~   "
270131|NCT00051792|"~     The purpose of this study is to evaluate the safety and effectiveness of yoga in reducing~     shortness of breath in people with chronic obstructive pulmonary disease (COPD). Patients in~     this study must have moderate to severe COPD and be primarily limited by shortness of breath.~   "
270132|NCT00051779|"~     This study is intended to evaluate the safety, tolerability, and possible effectiveness of an~     investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related~     protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to~     bone.~      The study will also evaluate the possible effects of both study drugs on performance status,~     markers of bone metabolism, and skeletal events related to bone metastasis including elevated~     blood calcium levels, bone pain, metastatic lesions, complications and interventions. The~     levels of CAL in the blood will also be evaluated.~   "
270133|NCT00051766|"~     The purpose of this study is to evaluate the effectiveness of a computer-assisted,~     self-administered adherence program for patients on complicated anti-HIV drug regimens.~   "
270134|NCT00051753|"~     The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with~     amoxicillin/clavulanate on the clinical response at the end of therapy in infants and~     children who have recurrent and/or persistent acute otitis media.~   "
270135|NCT00051740|"~     This study will compare Cognitive Adaptation Training (CAT) to minimal schizophrenia~     treatment. This study will also determine whether the intensity of CAT can be reduced and~     still provide benefits to patients with schizophrenia.~   "
270136|NCT00051727|"~     The purpose of this study is to test the efficacy of a family-based psychosocial intervention~     to prevent school disengagement and reduce the incidence of depression, conduct disorders,~     and school dropout for Mexican American adolescents.~   "
270137|NCT00051701|"~     The purpose of this study is to determine the optimal dose of Campath for patients with~     relapsing or refractory (failed standard therapy) non-Hodgkin's lymphoma. The study will also~     evaluate the safety of the drug and whether it is effective in treating these patients.~   "
270138|NCT00051688|"~     The primary purpose of this study is to determine the best dose of tezacitabine when combined~     with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate~     tumor response to the combination of anti-cancer drugs.~   "
270139|NCT00051675|"~     The purpose of this study is to evaluate the safety, immunogenicity, and tolerability of a~     monoclonal antibody administered subcutaneously in the treatment of advanced cancers of the~     ovary, breast, lung, prostate, colon or rectum that are either refractory to standard~     therapies or for which therapies that may potentially be of major benefit do not exist.~   "
270140|NCT00051662|"~     The purpose of this study is to determine whether a humanized monoclonal antibody~     (efalizumab) is safe and effective in the treatment of psoriatic arthritis (PsA)~   "
270141|NCT00051636|"~     The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.)~     infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone.~     The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The~     extended observation period included participants of the core study who responded to~     treatment.~   "
270142|NCT00051623|"~     The purpose of this study is to determine if Infliximab is safe and effective in the~     treatment of psoriatic arthritis. Infliximab (Remicade) targets specific proteins in the~     body's immune system to help control the development of inflammation to help reduce painful~     disease.~   "
270143|NCT00051597|"~     The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric~     monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic~     malignancies.~      This is a single-arm, open-label phase I/II study designed to define the toxicity profile,~     pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in~     patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will~     be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics~     (TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a~     weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose~     (MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.~   "
270986|NCT00040053|"~     The purpose of this study is to assess ondansetron for the treatment of methamphetamine~     dependence.~   "
270144|NCT00051584|"~     This is an open-label, randomized phase II trial comparing treatment with a monoclonal~     antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly~     Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study~     are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to~     estimate the clinical response rate and to estimate the duration of response of this~     combination therapy administered to patients with advanced ovarian cancer, compared to~     treatment with Gemzar® alone.~   "
270145|NCT00051571|"~     This randomized phase II clinical trial evaluates the combination of a monoclonal~     antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given~     alone in patients with non-small cell lung cancer that has failed at least one prior systemic~     therapy. The objective of the study is to determine the safety and clinical benefit, as~     measured by tumor response and quality of life, to the combination regimen.~      Monoclonal antibody therapy has been used in other types of cancer to target therapy to the~     tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal,~     healthy tissue.~   "
270146|NCT00051428|"~     The purpose of this study is to investigate the effectiveness of Reiki in the treatment of~     fibromyalgia (FM), a condition characterized by widespread muscle pain and stiffness, often~     accompanied by sleep disturbance, headaches, irritable bowel syndrome, and psychological~     distress. Reiki is a form of energy medicine in which practitioners reportedly access~     universal life energy to heal patients, either by direct contact at specific hand positions~     or from a distance.~   "
270147|NCT00051415|"~     Flaxseed, a rich source of fiber, may be a significant component of a cholesterol-reducing~     diet. The purpose of this study is to evaluate the safety and effectiveness of flaxseed in~     reducing high cholesterol.~   "
270148|NCT00051402|"~     The purpose of this study is to investigate whether soy-derived phytoestrogens taken as~     dietary supplements improve memory function in postmenopausal women who have experienced~     early memory decline.~   "
270149|NCT00051558|"~     Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and~     there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed~     to treat a large number of conditions such as arthritis and asthma. When taken for several~     months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis~     called glucocorticoid-induced osteoporosis. This study compared the effects of~     teriparatide, the study drug, with alendronate, an approved drug for treating~     glucocorticoid-induced osteoporosis.~   "
270150|NCT00051545|"~     To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended~     curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol~     injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation~     therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).~   "
270151|NCT00051532|"~     The purpose of the study is to determine whether seocalcitol is effective in the treatment of~     advanced primary liver cancer (hepatocellular carcinoma [HCC]).~   "
270152|NCT00051506|"~     The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus~     Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer.~   "
270153|NCT00051493|"~     The purpose of this study is to evaluate the effects (good and bad) of LY231514 (ALIMTA) and~     Carboplatin on you and your non-small cell lung cancer.~   "
270154|NCT00051519|"~     This screening study will evaluate potential study volunteers with HIV infection to see if~     they are suitable candidates for trials of experimental vaccines against HIV (therapeutic),~     and against other infections (preventive).~        -  Preventive vaccines against other infections. Preventive vaccines prevent a person from~          getting a disease. Preventive vaccines have been developed for many diseases, including,~          for example, whooping cough, measles, mumps, influenza, and hepatitis B. Some preventive~          vaccines may also prevent a disease from taking hold if given immediately after~          infection, such as vaccines for rabies, smallpox and hepatitis.~        -  Therapeutic vaccines against HIV. Therapeutic vaccines are intended to treat someone who~          has already been infected, with the goal of controlling the disease or preventing it~          from causing severe illness. As yet, there are no therapeutic vaccines for any diseases.~        -  Vaccines against other infections. Vaccines to prevent other infections besides HIV may~          need to be tested separately in people with HIV infection because the immune system~          works differently when HIV infection is present.~      HIV-infected patients 18 years of age or older may be eligible for this screening study.~     Women who are pregnant or breast feeding may not participate.~      Participants will be screened with the following:~        -  A health history, including questions about sexual activity and drug use;~        -  Physical examination, including blood and urine tests;~        -  HIV testing to confirm HIV infection;~        -  Pregnancy test for premenopausal women;~        -  PPD test for tuberculosis for those who have not been tested in the previous 6 months.~      Candidates who meet the requirements for investigational vaccine studies will be invited to~     participate in a study. Those who do not begin a study within 1 month of the screening tests~     may need to repeat some tests for continued consideration. In addition, some studies require~     repeated measures of CD4 counts and viral load over a period of a few months.~   "
270155|NCT00051480|"~     The primary purpose of this study is to assess the safety and feasibility of giving TNFerade™~     with 5-FU, Cisplatin and radiation therapy to patients with locally advanced, esophageal~     cancer prior to surgical resection. TNFerade™ is a replication deficient (E1, E3 and E4~     deleted) adenovirus vector containing the gene for TNF-alpha controlled by a radiation~     inducible promoter. This allows the expression of TNF-alpha to be greatest in the area~     receiving radiation. TNF-alpha is a potent cytokine that has been shown to have potent~     anti-cancer activities but, due to systemic toxicity, could not be delivered at effective~     doses. TNFerade™ is a novel way of selective delivery of TNF-alpha to tumor cells.~      TNFerade™ will be delivered once a week for five weeks by direct intratumoral injection by~     using endoscopy or Endoscopic Ultrasound. 5-FU (1000 mg/m2/day) will be delivered via~     continuous infusion for 96 hours during weeks 1 and 4. Cisplatin (75 mg/m2) will be delivered~     on Day 1 and Day 29 intravenously. The dose of radiation delivered will be 45 Gy in 1.8 Gy~     fractions for 5 weeks.~   "
270156|NCT00051467|"~     The primary purpose of this study is to assess the safety and effectiveness of TNFerade™~     Biologic when administered concurrently with 5-FU and radiation therapy as first-line~     treatment of unresectable locally advanced pancreatic cancer.~      TNFerade™ is a replication deficient adenovirus vector containing the gene for TNF-alpha~     controlled by a chemoradiation inducible promoter. This allows the expression of TNF-alpha to~     be greatest in the area receiving radiation. TNF-alpha is a cytokine that has been shown to~     have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at~     effective doses. TNFerade™ Biologic is a novel way of selective delivery of TNF-alpha to~     tumor cells.~      TNFerade™ Biologic will be injected during five weekly injection sessions, concomitant with~     radiation and 5-FU. TNFerade™ Biologic will be administered by direct intratumoral injection~     using a percutaneous approach (PTA) or endoscopic ultrasound (EUS).~   "
270158|NCT00051441|"~     The purpose of this study is to compare the effectiveness and safety of benzydamine~     hydrochloride 0.15% oral rinse to a vehicle oral rinse in the treatment of radiation-induced~     oral mucositis, and to compare the care normally used for radiation-induced oral mucositis to~     vehicle oral rinse to ensure that the vehicle does not have detrimental effects on the oral~     mucosa~   "
270159|NCT00051389|"~     To determine the effects of an angiotensin converting enzyme inhibitor (ACE inhibitor),~     fosinopril, on multiple blood markers in 286 adults at high risk for cardiovascular disease.~   "
270160|NCT00051376|"~     The body produces a natural compound, nitric oxide (NO), which is known to improve the~     elasticity of blood vessels effect cardiac function and play a role in the remodeling process~     after a heart attack. The primary source of NO is one of the amino acids that the body uses~     to form new proteins, L-Arginine; although many individuals with heart disease also take~     medicines to increase the concentrations of NO such as nitroglycerine. The VINTAGE-MI trial~     is intended to investigate wether supplementation of the bodies supply of NO with oral~     administration of L-Arginine will improve the functional recovery of older patients who have~     recently suffered their first heart attack.~   "
270161|NCT00051363|"~     The purpose of this study is to determine the effectiveness of nasal continuous positive~     airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome (OSAS).~   "
270162|NCT00051350|"~     To compare the effects on blood pressure and plasma lipids of three different diets--a~     carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.~   "
270163|NCT00051337|"~     This study will use single photon emission computed tomography (SPECT) to determine what~     areas of the brain are responsible for paroxysmal hyperkinetic movement disorders. Patients~     with these disorders have sudden, brief attacks of movement, similar to epileptic seizures,~     but without loss of consciousness. SPECT is a nuclear medicine test that produces~     three-dimensional images of the brain, showing blood flow and function in different brain~     regions. This test, which can detect the focus of epileptic seizures, will be used in this~     study to scan patients while they are experiencing a hyperkinetic movement attack, while they~     are not having and attack, and while they are simulating an attack.~      Patients 18 years of age and older who have paroxysmal movement attacks that can be easily~     induced by a specific trigger, such as a sudden movement or prolonged exercise, may be~     eligible for this study. Candidates will be screened with a medical history and review of~     their medical records, physical examination, videotape of attacks, and, for women, a~     pregnancy test.~      Participants will have three SPECT scans, separated from each other by at least 48 hours.~     Before each scan, the subject will perform an activity that ordinarily precipitates a~     movement attack, such as standing up from a chair, assuming a certain posture, or doing~     something strenuous. Each scan will try to record one of the following conditions:~        -  The subject performs the trigger activity, but does not have an attack;~        -  The subject performs the trigger activity and has an involuntary attack as a result;~        -  The subject performs the trigger activity and does not have an attack, but then mimics~          an attack voluntarily.~      After the condition is recorded, the subject will be given an injection of a radioactive~     agent called 99m Technetium and will then relax quietly for 40 to 60 minutes before the SPECT~     scan. For the scan, the subject lies on an examination table and the SPECT camera is moved~     near and around the head to image the brain. The scan takes about 40 minutes.~      Participants will also undergo one magnetic resonance imaging (MRI) scan. For this test, the~     subject lies in a narrow cylinder (the scanner), while pictures of the brain are taken.~     Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency~     circuits used in the scanning process. The procedure takes about 30 minutes.~   "
270164|NCT00051324|"~     The purpose of this trial is to study early brain and behavioral changes in people who have~     the gene expansion for Huntington's disease, but are currently healthy and have no symptoms.~   "
270165|NCT00051298|"~     This study is to determine the efficacy (how well the drug works), safety, and any side~     effects of olanzapine compared to placebo in the treatment of schizophrenia in adolescents.~     Both the potential benefits and side effects of olanzapine will be evaluated throughout this~     trial.~   "
270166|NCT00051285|"~     To determine if low-dose enoximone therapy is an effective treatment for advanced chronic~     heart failure.~   "
270167|NCT00051311|"~     This study will investigate the safety and effectiveness of a modified stem cell transplant~     procedure for treating cancers of the blood and immune system. Patients with cancers and~     pre-cancerous conditions originating in blood or immune system cells can sometimes benefit~     greatly from, and even be cured by, transplants of stem cells (cells produced by the bone~     marrow that mature into blood cells). In addition to producing new bone marrow and restoring~     normal blood production and immunity, the donated cells fight any residual tumor cells that~     might have remained in the body, in what is called a graft-versus-tumor effect.~      However, severe problems, and sometimes death, may follow these transplants as a result of~     the high-dose chemotherapy and radiation that accompany the procedure. Also, donated immune~     system cells called T cells sometimes attack healthy tissues in a reaction called~     graft-versus-host-disease (GVHD), damaging organs such as the liver, intestines and skin.~     This study will use the following strategies to try to reduce these risks:~        -  induction chemotherapy to reduce patients immunity in an attempt to prevent rejection of~          the donated stem cells;~        -  reduced-intensity conditioning chemotherapy that is easier for the body to tolerate and~          involves a shorter period of complete immune suppression;~        -  donation of immune cells called Th2 cells instead of T cells to try to reduce the risk~          of serious GVHD;~        -  treatment with methotrexate and cyclosporine to try to reduce the risk of serious GVHD.~      Patients between 12 and 75 years of age with non-Hodgkin s lymphoma, Hodgkin s lymphoma,~     multiple myeloma, chronic lymphocytic leukemia, chronic myelogenous leukemia, acute~     myelogenous leukemia, acute lymphocytic leukemia, myelodysplasia, idiopathic myelofibrosis,~     polycythemia vera, or chronic myelomonocytic leukemia may be eligible for this study.~     Candidates will have a medical history, physical and dental examinations, blood and urine~     tests (including a blood test for genetic match with the donor), lung and heart function~     tests, and X-ray studies. A bone marrow biopsy may be done to evaluate disease status.~     Patients with lymphoma may have a nuclear medicine test called a positron emission tomography~     (PET) scan.~      Participants will have a central venous line (large plastic tube) placed into a major vein.~     This tube can stay in the body and be used during the entire treatment period to deliver the~     donated stem cells and give medications, including chemotherapy and other drugs, antibiotics~     and blood transfusions, and to withdraw blood samples. Treatment will start with induction~     chemotherapy, which will include the drugs fludarabine, cyclophosphamide, etoposide,~     doxorubicin, vincristine, and prednisone. Some patients may also receive an antibody called~     rituximab. Patients will receive one to three cycles of this treatment, depending on their~     response to the drugs. (One cycle consists of 5 days on drug therapy followed by a 16-day~     rest period.) Several days before the transplant procedure, patients will start conditioning~     chemotherapy with cyclophosphamide and fludarabine. Three days after the conditioning therapy~     is completed, the stem cells will be infused. To help prevent GVHD, patients will take four~     doses of methotrexate (by vein) shortly after the transplant, and cyclosporine (by mouth or~     by vein) for about 6 months after the transplant.~      The average hospital stay for stem cell transplantation is 3 to 4 weeks. After discharge,~     patients will return for frequent follow-up visits for 3 months. Monthly visits will be~     scheduled for the next 3 months, then every 3 months for the next 18 months, and less~     frequently for a total of at least 5 years post-transplant. These visits will include bone~     marrow aspirates and biopsies, blood draws, and other tests to monitor disease status.~   "
270168|NCT00051272|"~     This study will evaluate the effects of two antidepression medications on sexual functioning.~   "
270169|NCT00051259|"~     The purpose of this trial is to study the effects of two depression medications on sexual~     functioning.~   "
270170|NCT00051246|"~     This study will compare standard individual treatment to group therapy for the treatment of~     postpartum depression.~   "
270171|NCT00051233|"~     The purpose of this study is to assess the effectiveness of a Web-based psychoeducational~     program in helping people with schizophrenia and their families manage the disease.~   "
270172|NCT00051220|"~     This study will compare the effectiveness of three treatments in reducing symptoms of phobia~     in children and adolescents.~   "
270173|NCT00051207|"~     This 6-month study, with a 3-month follow up period, will compare the effectiveness of new~     and traditional psychotherapies for depression with panic or anxiety symptoms.~   "
270174|NCT00051194|"~     To compare the intraocular pressure(IOP)-lowering efficacy of morning or evening~     instillations of a combination IOP-lowering therapy in patients with open-angle glaucoma or~     ocular hypertension.~   "
270175|NCT00051181|"~     To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is~     equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure~     glaucoma.~   "
270176|NCT00051168|"~     Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular~     hypertension.~   "
270177|NCT00051155|"~     To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with~     open-angle glaucoma or ocular hypertension.~   "
270178|NCT00051142|"~     The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost~     (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or~     ocular hypertension.~   "
270179|NCT00051129|"~     The purpose of this study was to evaluate anecortave acetate compared to placebo for~     maintenance of visual acuity after 24 months of treatment in patients with subfovial~     choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).~   "
270180|NCT00051116|"~     To evaluate the response rate, response duration, and survival of patients treated with~     CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.~   "
270181|NCT00051103|"~     The purpose of this study is to determine the efficacy of an oral investigational drug for~     the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.~   "
270220|NCT00050583|"~     The purpose of this study is to compare cognitive behavior therapy (CBT) to medical~     care-as-usual for the treatment of patients with high levels of medically unexplained~     physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of~     CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.~   "
270182|NCT00051090|"~     This study will evaluate the drug telbivudine (LdT) for treatment of hepatitis B virus (HBV)~     in HIV infected patients. Patients will take telbivudine alone for 24 weeks, add anti-HIV~     drugs for 24 weeks, then stop taking telbivudine while continuing their anti-HIV drug~     regimen. To enroll in this study, patients must not be taking any anti-HIV drugs and cannot~     have taken more than 31 days of treatment with lamivudine (3TC), protease inhibitors (PIs),~     or nonnucleoside reverse transcriptase inhibitors (NNRTIs).~   "
270183|NCT00051077|"~     This study will investigate the safety and effectiveness of using adefovir dipivoxil (ADV),~     pegylated interferon (PEG-INF), and ribavirin (RBV) in patients triple-infected with~     hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV. Patients in this study must be~     taking lamivudine (3TC).~   "
270184|NCT00051051|"~     CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may~     be involved in tumor growth. The primary objective of this study is to assess the antitumor~     activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically~     confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior~     cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally.~     Patients are required to have blood tests periodically while receiving treatment and will be~     closely monitored throughout the study for possible side effects and response to treatment.~     Patients may not have received any prior treatment with other agents that target erbB~     receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).~   "
270185|NCT00051038|"~     The purpose of this clinical research study is to assess the safety and effectiveness of~     entecavir, when being added to lamivudine, in the treatment of adults with chronic hepatitis~     B infection who are co-infected with HIV.~   "
270186|NCT00051025|"~     The purpose of this study is to look at the safety and effectiveness of ONTAK in previously~     treated patients with NHL.~   "
270187|NCT00051012|"~     The purpose of this study is to provide an opportunity for patients who exhibit progressive~     disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also~     designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients~     whose tumors do not express CD25.~   "
270188|NCT00050999|"~     The purpose of this study is to compare the effectiveness of two dose levels of ONTAK~     (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell~     lymphoma.~   "
270189|NCT00050986|"~     The goal of this clinical research study is to find the highest safe dose of the new drug~     ZARNESTRA (R115777) and temozolomide that can be given to patients with brain tumors~     (glioblastoma multiforme, GBM). The second goal is to learn if these drugs given in~     combination can shrink or slow the growth of brain tumors. The safety of this treatment will~     also be studied.~   "
270190|NCT00050973|"~     This study evaluates the use of Targretin capsules (bexarotene) in combination with standard~     chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients~     who have not yet received chemotherapy for their lung cancer.~   "
270191|NCT00050960|"~     This study evaluates the use of Targretin capsules (bexarotene) in combination with standard~     chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients~     who have not yet received chemotherapy for their lung cancer.~   "
270192|NCT00050947|"~     This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as~     monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of~     age.~   "
270193|NCT00050934|"~     This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on~     therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.~   "
270194|NCT00050921|"~     This study is designed to evaluate the ability of growth hormone (GH, also known as~     somatropin) to increase CD4+ cell counts in patients taking anti-HIV drugs. The study is~     targeted toward patients with low levels of HIV who continue to have low CD4+ cell counts.~   "
270195|NCT00050908|"~     This is a substudy of ACTG A5142. The purpose of this substudy is to evaluate blood vessel~     function in HIV-infected patients taking anti-HIV drugs.~   "
270196|NCT00050895|"~     With new strategies and drugs available, many different regimens exist for the treatment of~     HIV. The purpose of this study is to compare three different anti-HIV drug regimens as~     first-time treatments for HIV infection.~   "
270197|NCT00050882|"~     This study is intended to evaluate the potential to relieve the symptoms associated with~     gastroparesis during 12 weeks of treatment with oral tablets given twice a day of GM-611 5mg,~     10mg or placebo to type I or II diabetics who require insulin.~      Additionally the study will evaluate the safety and tolerability of GM-611 compared to~     placebo, the levels of GM-611 in the blood, and the possible effect of GM-611 on diabetic~     control.~   "
270198|NCT00050869|"~     Motor training results in use dependent plasticity (UDP), thought to underlie recovery of~     motor function after brain injury. The purpose of this protocol is to determine (a) if~     movement observation results in encoding of a motor memory in the primary motor cortex and~     (b) if observation of motor training can enhance the effects of physical training in healthy~     volunteers. If so, this may become an important tool in rehabilitative treatment for patients~     who are unable or partially able to train. We will test our hypotheses by means of focal~     single pulse transcranial magnetic stimulation (TMS) in a group of healthy volunteers. Our~     outcome measure will be the change in TMS-evoked movement direction as a function of training~     strategy. So far we found that this is the case in healthy volunteers (see data in analysis~     of the study). The purpose of this amendment is to determine if action observation can elicit~     the same effects in adult chronic ischemic stroke patients who have had originally~     significant motor weakness but recovered to the point of being able to perform the motor~     tasks, possibly resulting in a useful rehabilitative strategy.~   "
270221|NCT00050570|"~     The purpose of this study is to determine whether a web-based program is effective in~     reducing the incidence of eating disorders in college women who are at high risk for~     developing an eating disorder.~   "
270222|NCT00050557|"~     The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation~     Group for the families of children with mood disorders.~   "
270987|NCT00040040|"~     The purpose of this study is to assess potential interactions between intravenous (IV)~     methamphetamine and oral bupropion.~   "
270199|NCT00050856|"~     This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together~     with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an~     antiretroviral drug. Unlike other antiretrovirals, however, which work against the virus once~     it is already in the cell, Fuzeon prevents the virus from getting into healthy cells.~      Patients 18 years of age and older with advanced HIV-1 infection, who do not respond to~     approved antiretroviral therapy, may be eligible for this study. Candidates must have a CD4~     lymphocyte count less than 100 cells/mm3 and a viral load greater than 10,000 copies/mL. They~     will be screened with a medical history, physical examination, and blood tests, and may also~     have an electrocardiogram (ECG), chest x-ray and urine test.~      Patients enrolled in the study will be re-examined and have additional blood tests before~     beginning treatment with Fuzeon. They will then be taught how to self-inject the medicine~     under the skin and will take two doses daily (less than 1/4 teaspoon each), 12 hours apart.~     After the first treatment, participants will have follow-up visits at weeks 1, 2, 4, 8, 12,~     24, 36, 48, and every 12 weeks after that, if necessary, until 12 weeks after the drug~     becomes commercially available. Visits may be scheduled more often if a problem arises.~     During the follow-up visits, patients will have blood drawn, and their blood pressure, pulse~     rate and temperature will be checked. They will also report any drug side effects they have~     experienced.~      Patients may continue to take Fuzeon as long as they benefit from therapy and do not~     experience severe side effects from the treatment. The drug will be provided to participants~     until 12 weeks after it is sold in the United States.~   "
270200|NCT00050843|"~     The primary objective of the study is to determine the efficacy of thalidomide for the~     treatment of anemia in patients with myelodysplastic syndromes (MDS).~   "
270201|NCT00050830|"~     The purpose of study to determine the activity of CI 1033 against tumors in patients with~     advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy.~     Another objective is to determine the safety of CI 1033.~   "
270202|NCT00050817|"~     RATIONALE:~        -  Atherothrombosis is a progressive and generalized vascular disease resulting in events~          leading to myocardial infarction (heart attack), stroke, and vascular death.~        -  In patients at risk for this disease, it is characterized by an unpredictable, sudden~          disruption of atherosclerotic plaques, which may lead to total occlusion of artery due~          to formation of a clot. The use of aspirin (blood thinner agent) for reducing those~          major ischemic events is either indicated, or recommended by international guidelines.~          However, aspirin fails to prevent a high percentage of such life-threatening events.~          Therefore, more effective blood thinning therapy may provide additional clinical benefit~          to such patients.~        -  The results of the CURE trial in patients with unstable angina demonstrate the~          additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood~          thinner agent), when administered in combination with standard therapy including~          aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of~          clopidogrel may apply to a broad population of high-risk patients receiving low-dose~          aspirin therapy. Such population includes patients with previous cardiovascular,~          neurovascular or peripheral arterial manifestations of atherothrombosis and patients~          with combinations of recognized risk factors for atherosclerosis.~      OBJECTIVES:~        -  To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in~          preventing cardiovascular morbidity/mortality. The study will compare the efficacy of~          the two regimens in preventing the occurrence of major cardiovascular complications~          (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise~          receiving low-dose aspirin therapy (75-162 mg daily).~        -  To evaluate the safety of clopidogrel in this population, and more specifically the~          incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate~          the global benefit of clopidogrel in this patient population.~   "
270203|NCT00050791|"~     This is a double blind placebo controlled clinical study designed to determine the effects of~     leptin on the changes that occur in the body during weight loss achieved by a very low~     calorie diet.~   "
270204|NCT00050778|"~     This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two~     different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon~     beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis~     (MS) who had not been previously treated with MS therapies other than steroids. The study was~     conducted for an initial period of 3 years and a follow-up to 5 years or more.~   "
270205|NCT00050804|"~     The purpose of this study is to examine the short-term consequences of trauma and to~     determine the effectiveness of the drug sertraline in preventing and treating post-traumatic~     stress disorder (PTSD) and acute stress disorder (ASD) symptoms.~      ASD and PTSD are common consequences of exposure to traumatic events. Despite growing~     evidence of neurobiological dysfunction in ASD and PTSD, the origin of these disorders is~     still unknown. This study will attempt to identify psychophysiological markers of ASD and~     find an effective treatment for its symptoms.~      Victims of serious motor vehicle collisions will be evaluated with clinical assessments and~     standardized questionnaires within 2 weeks after the accident. Symptoms of exaggerated~     startle, emotional reactivity to trauma-related and trauma-unrelated cues, and cerebellum~     functioning will be evaluated. Participants will be randomized to receive either sertraline~     or placebo (an inactive sugar pill) for 8 weeks. Psychometric testing and psychological~     evaluations will be conducted 4, 10, and 14 weeks after the accident and after a 2-week taper~     of the study medication.~   "
270206|NCT00050765|"~     MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a~     new dimension to the management of post-infarct deterioration of cardiac function. Based on~     existing non-clinical studies and clinical reports, implantation of autologous skeletal~     myoblasts appears to lead to the replacement of non-functioning myocardial scar with~     functioning muscle and appears to improve myocardial performance relative to case without~     myoblast implantation. In a few investigational patients, myoblast implantation can be, and~     has been, done in conjunction with CABG and appears to have the potential to provide for~     additive treatment during surgery. The present study is being conducted to evaluate more~     fully the safety of MyoCell™ implantation via epicardial injection during CABG surgery and~     its effect on regional myocardial function.~   "
270207|NCT00050687|"~     This study will test the safety, tolerance, and efficacy of different doses of oral gallium~     maltolate. Patients will receive oral gallium maltolate twice daily for 28-consecutive days~     followed by 14 days off treatment. This dosing cycle will be repeated. Adverse effects will~     be assessed and the levels of gallium in serum will be measured. Any effect of the drug on~     the cancer and any improvement in cancer-related symptoms will also be measured.~   "
270491|NCT00050102|"~     The objectives of this study are to determine the safety and activity profile of multiple~     doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy~     (decarbazine [DTIC]) can augment the effects of MDX-010 in patients with chemotherapy naïve~     metastatic melanoma with a tolerable toxicity profile.~   "
270208|NCT00050752|"~     This study will investigate what causes hereditary leiomyomatosis renal (kidney) cell cancer,~     or HLRCC, and how the disease is related to the development of kidney tumors. Leiomyomas are~     benign (non-cancerous) tumors arising from smooth muscle. HLRCC can cause various health~     problems. Some people develop red bumps on their skin that can be painful at times. Some~     women with HLRCC can develop leiomyomas of the uterus. In some families, people with HLRCC~     develop kidney tumors. This study will try to determine:~        -  What gene changes (mutations) cause HLRCC~        -  What kind of kidney tumors develop in HLRCC and how they grow~        -  What the chance is that a person with HLRCC will develop a kidney tumor~      People with known or suspected HLRCC (and their family members of any age) may be eligible~     for this study. This includes people in families in which one or more members has skin~     leiomyoma and kidney cancer; skin leiomyoma and uterine leiomyoma; multiple skin leiomyomas;~     kidney cancer and uterine leiomyomas, or kidney cancer consistent with HLRCC, including, but~     not limited to, collecting duct or papillary, type II. Candidates will be screened with a~     physical examination, family history, and, for affected family members, a review of medical~     records, including pathology slides and computed tomography (CT) or magnetic resonance~     imaging (MRI) scans.~      Participants will undergo tests and procedures that may include the following:~        -  Review of medical records, x-rays, and tissue slides~        -  Physical examination and family history~        -  Skin examination~        -  Gynecological examination for women~        -  Interviews with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor~        -  Blood tests for:~             1. Genetic research to identify the gene responsible for HLRCC~             2. Evaluation of liver, kidney, heart, pancreas, and thyroid function~             3. Complete blood count and clotting profile~             4. Pregnancy test for pre-menopausal women~             5. PSA test for prostate cancer in men over age 40~        -  CT or MRI scans (for participants 15 years of age and older only)~        -  Skin biopsy (surgical removal of a small sample of skin tissue)~        -  Cheek swab or mouth rinse to collect cells for genetic analysis~        -  Medical photographs of lesions~        -  Questionnaire~      When the tests are completed, participants will discuss the results with a doctor and~     possibly a genetic nurse or genetic counselor. The genetic findings will not be revealed to~     participants because their meaning and implications may not yet be understood. Participants~     may be asked to return to NIH from every 3 months to every 3 years, depending on their~     condition, for follow-up examinations and tests.~   "
270209|NCT00050726|"~     This investigation is a sub-study of the 6-year multinational ESPRIT (Evaluation of~     Subcutaneous Proleukin in a Randomized International Trial) protocol. It will compare the~     effectiveness of the influenza (FLUVAC) and tetanus-pneumococcal (TEPVAC) vaccines in~     HIV-infected patients receiving interleukin-2 (IL-2) plus anti-HIV drugs with those receiving~     only anti-HIV drugs. IL-2 is a protein naturally produced by immune cells called lymphocytes.~     Lymphocytes from patients with HIV do not produce IL-2 normally. The ESPRIT trial is~     evaluating whether HIV-infected patients treated with antiretroviral drugs plus IL-2 have~     fewer serious infections and improved survival than those receiving only anti-HIV drugs.~      Participants in this sub-study will be drawn from patients enrolled in ESPRIT. They must be~     18 years of age or older, have HIV infection with no symptoms of significant HIV illness.~     They will be vaccinated against either influenza or tetanus and pneumococcus, as follows:~      FLUVAC~      Potentially eligible patients will be screened for the FLUVAC study during an ESPRIT~     follow-up visit. Those who are eligible and agree to participate will have 10 ml (1~     tablespoon) of blood drawn to assess baseline antibody levels and then receive the~     vaccination. They will be vaccinated annually for 3 years. A blood sample (10 ml) will be~     drawn 1 month after each vaccination to measure the immune response. Some of the blood drawn~     for this study will be stored and used for research purposes.~      TEPVAC~      Participants will have 10 ml of blood drawn to assess their baseline antibody levels. They~     will receive two vaccinations (tetanus and pneumococcus) 12 months after enrolling in ESPRIT~     and another two vaccinations 24 months after enrollment. A blood sample (10 ml) will be drawn~     1 month after each vaccination to measure the immune response. Some of the blood drawn for~     this study will be stored and used for research purposes.~   "
270210|NCT00050713|"~     This study will evaluate the safety and effectiveness of a new immunosuppressive drug,~     sirolimus, in reducing the amount of protein in the urine in patients with membranous~     nephropathy. This condition involves damage to the walls of tiny blood vessel filters in the~     kidneys called glomeruli, which allows blood proteins to leak into the urine. Patients have~     low blood protein levels and high blood cholesterol. Some patients may have leg swelling,~     impaired kidney function, blood vessel and heart disease, and a risk of emboli (blood clots~     that travel to the lungs). Drugs currently used to treat membranous nephropathy vary in their~     effectiveness among patients and can cause severe side effects.~      The Food and Drug Administration has approved sirolimus for suppressing the immune system of~     patients who have had a kidney transplant to reduce the risk of organ rejection. The drug~     does not have certain side effects that have caused problems for patients treated with other~     immunosuppressants, such as: prednisone (weight gain, round face, diabetes, weak and~     fractured bones, and cataracts); cyclophosphamide (fertility problems, bladder injury and~     bladder cancer, and other cancers); chlorambucil (fertility problems, seizures, acute~     leukemia, and other cancers); and cyclosporine (kidney toxicity, increased facial hair, and~     seizures).~      Patients 13 years of age or older with idiopathic membranous nephropathy or lupus membranous~     nephropathy may be eligible for this study. Candidates must have completed at least one month~     of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or~     angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical~     examination, blood tests, skin test for exposure to tuberculosis, and an examination for~     infection, cancers, and other conditions that can cause membranous nephropathy.~      Participants will take sirolimus once a day for 1 year, except for the first day of~     treatment, when they will take three doses to quickly bring their blood levels of the drug up~     to a therapeutic level. They will undergo evaluations at the NIH in Bethesda, Maryland, at~     baseline (before starting treatment) and again at 1- to 4-month intervals during the study.~     In addition, they will have blood tests every week for the first month and every 2 weeks for~     the second month; then blood and urine tests once a month for the next 10 months of treatment~     and then every 4 months for a 12-month period after treatment stops. These tests will~     evaluate drug side effects and the response to therapy, and will determine if the therapeutic~     benefits persist long-term when treatment stops.~      Patients will also be asked to have optional kidney function tests during the baseline~     evaluation and at the end of the follow-up period to measure kidney filtration and blood flow~     rates. Those who participate will be given fluids and other substances by vein to accurately~     measure kidney function. They will then have blood and urine samples collected about four~     times over a 1-hour period after drinking fluids to increase urine output.~      Patients who experience a substantial increase in proteinuria or substantial decrease in~     kidney function during the course of treatment will stop taking sirolimus and be taken off~     the study.~   "
270211|NCT00050700|"~     The purpose of this study is to use brain imaging technology to examine the role of certain~     brain receptors and the nervous system chemical acetylcholine in major depression.~      The cholinergic system involves the regulation of neurotransmitters and the brain receptors~     to which they bind. Evidence suggests that the cholinergic system may play a role in the~     development of depression. Acetylcholine is a neurotransmitter that binds to certain brain~     receptors called muscarinic cholinergic receptors. Cholinomimetic drugs (drugs that stimulate~     the cholinergic system) often exacerbate depressive symptoms in people with mood disorders~     and in healthy individuals. This increase in depressive symptoms may be caused by stimulation~     of muscarinic acetylcholine receptors (mAChRs), but further study is needed to confirm this.~     This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI)~     to study the function of mAChRs in individuals with depression.~      Participants in this study will undergo a physical examination, psychiatric interviews,~     neuropsychological tests, PET and MRI scans, and rating scales of depression, anxiety, and~     negative thinking symptoms. Questions about behavior and functioning will be asked and blood~     samples will be collected for genetic analysis.~   "
270212|NCT00050674|"~     Determine whether patients have a decreased incidence of grade 3 and grade 4 neutropenia when~     Filgrastim-SD/01 is given with docetaxel and gemcitabine in patients with advanced non-small~     cell lung cancer.~   "
270213|NCT00050661|"~     This study is designed to study disease relapse after NBUVB and how the administration of~     Daclizumab/placebo alters disease relapse.~   "
270214|NCT00050648|"~     This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab)~     and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed~     study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and~     Cyclosporine.~   "
270215|NCT00050635|"~     Currently there is an ongoing clinical trial for patients with chemotherapy induced diarrhea.~     This trial is being conducted to evaluate the efficacy of two dose levels (30 mg and 40 mg)~     of an investigational drug in reducing the occurrence of severe (Grade 3 or 4) diarrhea~     during chemotherapy. Eligible patients must either have experienced NCI Common Toxicity Grade~     1 - 4 chemotherapy-induced diarrhea during previous chemotherapy treatment or be experiencing~     Grade 1-4 chemotherapy-induced diarrhea currently.~      In order to participate in this clinical trial, patients must be male or female 18 years of~     age or older. Inclusion into this investigational drug trial is based on the protocol entry~     criteria and a detailed evaluation from a participating trial investigator~   "
270216|NCT00050609|"~     The purposes of this study are to determine whether an experimental drug known as tadalafil~     can reduce symptoms of dyspepsia (fullness after eating, inability to finish a regular meal,~     bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting) in~     diabetic patients, and/or reduce the amount of time the stomach takes to empty the contents~     of a standard meal. The safety of tadalafil given once daily for 8 weeks in this population~     will also be studied.~   "
270217|NCT00050427|"~     The purpose of this study is to test the safety and effectiveness of an investigational~     chemotherapy agent in patients with advanced breast cancer.~   "
270218|NCT00050622|"~     The purpose of this study is to determine the effectiveness of behavioral treatment, drug~     treatment, and combined treatment for children with Attention Deficit Hyperactivity Disorder~     (ADHD). This study will also examine the interactions between different levels of behavioral~     and drug treatments.~   "
270219|NCT00050596|"~     The primary objectives of the study are to determine the safety and activity of multiple~     doses of MDX-010 in patients with hormone-refractory prostate cancer (HRPC), and to determine~     the safety and activity profile of a single dose of cytotoxic chemotherapy (docetaxel) in~     combination with MDX-010~   "
270509|NCT00049881|"~     To conduct genetic studies of the metabolic syndrome characterized by very low levels of high~     density lipoprotein cholesterol (HDL-C), hypertriglyceridemia, and obesity.~   "
270223|NCT00050518|"~     The study seeks to define, with precision, the safety and efficacy of APSV, two dose~     potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a~     classic �take� as defined by formation of a lesion at the injection site consistent with the~     �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed.~     The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of~     live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with~     takes for the Dryvax vaccine and is considered to be cross-protective for other~     orthopoxviruses, including variola. The study also seeks to characterize preliminarily the~     cell mediated immune (CMI) response to APSV (as compared to Dryvax).~   "
270224|NCT00050505|"~     The purpose of this study is to determine the safety and effect of diluting smallpox vaccine,~     making a larger number of doses in case smallpox is released into the environment. A total of~     up to 927 healthy adults between the ages of 32 and 70 years who were already vaccinated~     against smallpox (but not since 1989) will volunteer for this study for up to 34 weeks and~     receive different strengths of vaccine. Some subjects may participate for longer if they~     choose to be revaccinated because the first vaccination does not take. The vaccine will be~     given by making small cuts in the skin and putting the vaccine into these cuts. After the~     screening visit, volunteers will be followed through study visits and follow up phone calls.~     Blood will be collected during some study visits to look at the immune system (body system~     that fights infection) response.~   "
270225|NCT00050492|"~     This study will look for biological markers of primary retinal vasculitis that can be useful~     in understanding what causes the disease. It will evaluate its progression, and develop and~     monitor treatments. Biological markers are substances (e.g., chemicals called cytokines and~     chemokines or antibodies) that are associated with a disease or condition such as retinal~     vasculitis. Retinal vasculitis is an inflammation of blood vessels in the retina that can~     cause retinal damage and subsequent loss of vision. It can occur by itself (primary retinal~     vasculitis), or it can be part of a systemic vascular disease.~      The study will evaluate patients with primary retinal vasculitis and compare the findings~     with those of two other groups of patients with retinal vasculitis patients with Behcet's~     syndrome and HIV-infected patients undergoing HAART therapy.~      Patients over 10 years of age with sight-threatening retinal vasculitis may be eligible for~     this study. (page 6 of the protocol, under #4 Study Design and Methods, says the age range is~     2 years old and above; page 10, under #5 Participant Inclusion and Exclusion Criteria, says~     initial enrollment will include all patients over the age of 10 years).~      Upon entering the study, participants will have about 10 teaspoons of blood withdrawn from an~     arm vein through a needle and again 6 months and 12 months later. The blood samples will be~     analyzed for cytokines, chemokines or adhesion molecules, certain types of antibodies, and~     infectious agents.~   "
270226|NCT00050479|"~     This study will compare the side effects of two laser treatments for diabetic macular edema,~     a common condition in patients with diabetes. In macular edema, blood vessels in the retina,~     a thin layer of tissue that lines the back of the eye become leaky and the retina swells. The~     macula, the center part of the retina that is responsible for fine vision may also swell,~     causing vision loss. Traditional laser treatment (argon blue or green or yellow) for macular~     swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision.~     Studies with a different type of laser (diode) may be less damaging. The results of this~     study on side effects of the treatments will be used to design a larger study of~     effectiveness. This study will also examine whether celecoxib (Celebrex® (Registered~     Trademark)), an anti-arthritis drug that reduces inflammation and swelling, can reduce~     inflammation and swelling of the retina. Patients with elevated cholesterol levels will be~     invited to participate in a cholesterol reduction part of the study to compare normal-pace~     cholesterol reduction with accelerated reduction.~      Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema that~     requires laser treatment may be eligible for this study. Candidates will be screened with the~     following tests and procedures:~        -  Medical history: to review past medical conditions and treatments.~        -  Physical examination: to measure vital signs (pulse, blood pressure, temperature,~          breathing rate) and examine the head and neck, heart, lungs, abdomen, arms and legs.~        -  Eye examination: to assess visual acuity (eye chart test) and examine pupils, lens,~          retina, and eye movements. The pupils will be dilated with drops for this examination.~        -  Blood tests: to measure cholesterol, blood clotting time, hemoglobin A1C (a measure of~          diabetes control), and to evaluate liver and kidney function.~        -  Eye photography: to help evaluate the status of the retina and changes that may occur in~          the future. Special photographs of the inside of the eye are taken using a camera that~          flashes a bright light into the eye. From 2 to 20 pictures may be taken, depending on~          the eye condition.~        -  Fluorescein angiography: to evaluate the eye's blood vessels. A yellow dye is injected~          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina~          are taken using a camera that flashes a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating possible blood vessel~          abnormality.~      Participants will be randomly assigned to take celecoxib or placebo (an inactive, look-alike~     pill). Participants who have elevated cholesterol levels may return for a brief visit after 1~     month. All patients will return for follow-up visits at 3, 6, and 12 months. Patients who~     require laser treatment will be randomly assigned to one of the two laser treatments. For~     these procedures, eye drops are put in the eye to numb the surface and a contact lens is~     placed on the eye during the laser beam application. Several visits may be required for~     additional laser treatments. The maximum number of treatments depends on how well the~     treatment is working. Patients who respond well to the study medication may receive no laser~     treatments. After the first year, patients will be followed every 6 months until either the~     patient returns for a 3-year visit, the last enrolled patient returns for the 1-year visit,~     or the patient requests to leave the study. During the follow-up visits, patients' response~     to treatment will be evaluated with repeat tests of several of the screening exams.~   "
270227|NCT00050466|"~     This pilot study will examine the usefulness of a new instrument called the Dynamic Light~     Scattering (DLS) device for documenting and monitoring changes in the cornea, the front part~     of the eye where contact lenses are placed. The DLS device uses a low-intensity laser similar~     to that used in supermarket checkouts to measure the cloudiness of the cornea. The results of~     this study may lead to further investigations using DLS to discover the cause of corneal~     clouding and to develop treatments to prevent it.~      Healthy volunteers and patients with corneal clouding or opacification 18 years of age and~     older may be eligible for this study.~      Participants will have a standard eye examination, including a check of visual acuity and eye~     pressure. The retina will also be examined and photographs of the cornea may be taken. For~     the DLS test, the subject sits in front of the device and looks at a yellow-green target~     while the cloudiness of the cornea is measured. Subjects will be tested four times. The~     entire procedure takes less than 30 minutes.~   "
270228|NCT00050440|"~     The purpose of this is to test the safety and effectiveness of an investigational~     chemotherapy agent in patients with persistent or recurrent endometrial cancer.~   "
270229|NCT00050414|"~     The purpose of this study is to test the safety and effectiveness of an investigational~     chemotherapy agent in patients with advanced ovarian cancer.~   "
270230|NCT00050401|"~     The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.),~     along with another drug called an aminoglycoside (a different type of antibiotic) is~     effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa,~     Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult~     to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory~     support. The study hopes to show that by increasing the amount of meropenem administered and~     increasing the duration of infusion (release of the drug into the bloodstream), levels of the~     drug will stay at target levels in the bloodstream and decrease the ability of difficult to~     treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem)~     or other antibiotics.~   "
270231|NCT00011635|"~     Complementary and alternative medicines are widely used in the HIV-infected population.~     Recent data have shown serious drug interactions between certain complementary medicines and~     protease inhibitors. Silymarin (Milk thistle) is a commonly used dietary supplement in~     HIV-infected patients for treatment of hepatitis or as a hepato-protectant. Data are~     available suggesting that it may alter cytochrome P4503A4-mediated drug metabolism. To~     evaluate the effect of milk thistle on the protease inhibitor, indinavir (IDV), ten healthy~     subjects will receive IDV (Crixivan) alone and in combination with an over-the-counter~     silymarin preparation. IDV will initially be administered alone at a dose of 800 mg Q8H for~     four doses and serial samples will be collected for determination of IDV pharmacokinetics~     after the morning dose on day 2. Subjects will then initiate therapy will milk thistle using~     a standardized formulation and dose for three weeks after which subjects will then again take~     4 doses of IDV and have serial samples collected for IDV plasma concentrations. There will~     then be a 11-day washout period with no drugs, after which IDV will again be given for 4~     doses and samples will be collected evaluate the offset of the effects of milk thistle. To~     examine the effect of milk thistle on other CYP450 pathways, subjects will receive a single~     dose of caffeine and dextromethorphan and have urine collected before and after milk thistle,~     and after the washout period. Indinavir, caffeine, and dextromethorphan concentrations in~     plasma or urine will be determined using validated HPLC methods. Steady-state~     noncompartmental parameters of indinavir in the presence and absence of milk thistle will be~     determined. Pharmacokinetic parameters will be compared using ANOVA that will include factors~     for a period effect and a treatment effect. Statistical analyses will include calculation of~     the mean ratio of the AUC in the treatment phases compared to IDV alone and determination of~     95% confidence intervals. This study will help define the drug interaction potential of~     complementary and alternative therapies in HIV-infected patients.~   "
270510|NCT00049868|"~     To develop genetic maps for the genome-wide screening markers used by multiple investigators~     and to investigate map differences between sexes and different ethnic groups.~   "
270511|NCT00049855|"~     To develop new statistical methods to explore genetic mechanisms that contribute to the~     development of hypertension.~   "
270232|NCT00011063|"~     This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination~     of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and~     overall feeling of well being. Since this product is considered a food supplement and not a~     drug, it is not subject to the rigorous pre-market testing required for prescription and~     over-the-counter (OTC) drugs. As a result, information has not been collected on possible~     interactions between ginkgo biloba and other medications. This study will look at how ginkgo~     biloba affects the elimination of phenytoin-a medication used to treat patients with~     seizures.~      Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study.~     Candidates will provide a medical history and undergo a physical examination and routine~     blood tests. Women of childbearing age must use a reliable form of birth control other than~     oral contraceptives (the pill).~      For at least 2 weeks before the study and throughout its duration, study participants may not~     have any of the following: 1) medications that can affect platelet function (e.g., aspirin,~     Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit~     juice; and 4) all medications except those given by study personnel.~      On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty~     stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat~     breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at~     0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on~     this first study day is collected through a catheter (small plastic tube) placed in a vein to~     avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and~     then returns to the clinic for the remaining blood draws, which are taken by direct~     needlestick.~      When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center~     provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and~     8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of~     phenytoin as described above and repeat the blood sampling procedure. Subjects continue~     taking ginkgo during this second phenytoin study.~   "
270233|NCT00009542|"~     This study will examine how kava-a widely used herbal remedy-may affect the body's~     elimination of other medicines. Many people take kava to reduce anxiety or cause sedation.~     Since this product is considered a food supplement and not a drug, it is not subject to the~     rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a~     result, information has not been collected on possible interactions between kava and other~     medications. This study will look at how kava affects the elimination of caffeine-a compound~     commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough~     suppressant.~      Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study.~     Candidates will provide a medical history and undergo a physical examination and routine~     blood tests. Women of childbearing age will have a urine pregnancy test.~      Study participants will not drink alcoholic beverages or take any medications (except those~     given in the study) for 2 weeks prior to the study and throughout its duration. In addition,~     they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at~     least 72 hours before and throughout each study day that urine is collected.~      On day 1 of the study, study subjects will take one dose each of caffeine and~     dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then~     collect all their urine after the dosing for the rest of the day and including the next~     mornings first urine. They will bring the urine samples to the Clinical Center when the~     collection is complete. This procedure will be repeated 1 week later (study day 8). After the~     second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day~     for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the~     dextromethorphan and caffeine dosing and urine collection described above, while continuing~     to take kava.~      Subjects will have an electroencephalograph (EEG) done before starting kava and again at the~     end of kava (study day 30). For this procedure, several electrodes (metal cups attached to~     wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space~     between the electrode and the scalp to ensure good contact. The electrodes will remain in~     place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG~     recording.~      Participation in the study will end with another physical examination and blood tests~     following the second EEG and urine collection.~   "
270234|NCT00006395|"~     St. John's Wort is a popular dietary supplement that many patients-including those with~     epilepsy or seizures-take in addition to their regular medicines to elevate mood or relieve~     stress. Preliminary research indicates that this supplement can speed the metabolism of the~     anti-seizure drug Tegretol, causing reduced blood levels of the drug. Patients who take~     Tegretol to control their seizures may have more frequent seizures if the blood level of the~     drug drops too low. A recent study shows that this effect is not seen when Tegretol is taken~     for at least 3 weeks. The present study will examine whether there is a medically important~     drug interaction between St. John's wort and Tegretol when Tegretol is taken for 1 day.~      Normal healthy volunteers between 21 and 65 years old who are not taking medicines that can~     affect the metabolism of drugs in the liver and have not used St. John's wort for at least 30~     days may be eligible for this 25-day study.~      Participants will take a 400-mg dose of Tegretol after fasting overnight. Blood samples will~     be drawn the next day during a 12-hour clinic stay at the following intervals: just before~     the Tegretol dose and at 1, 2, 4, 6, 8, 10, 24, 34, 48 and 72 hours after the dose. A~     catheter will be placed in the vein to prevent the need for multiple needle sticks until~     after the 10-hour sample. After completing the blood sampling, participants will take 300 mg~     of St. John's wort 3 times a day with meals for 2 weeks. After 2 weeks, another fasting dose~     of Tegretol will be given and the 72-hour blood study will be repeated.~      This study may provide information important for the care of patients with epilepsy who take~     both Tegretol and St. John's Wort.~   "
270235|NCT00006191|"~     This study will examine the effect of the newly developed anti-epileptic drug, levetiracetam,~     on excitability of the cortex (surface layer) of the brain. Levetiracetam works differently~     from other anti-seizure drugs, but its mechanism is not well understood. This study may~     provide insight into a new protection mechanism against seizures as well as the effect of the~     drug on cortical excitability.~      Healthy normal volunteers 18 years of age and older may be eligible for this study.~     Candidates will have a medical history taken and undergo physical and neurological~     examinations.~      Participants will undergo two different procedures in four separate sessions. One procedure~     (cortical excitability) involves taking either levetiracetam or placebo (a look-alike~     inactive substance) and having transcranial magnetic stimulation (TMS). The other procedure~     (pinch-training related changes) involves taking levetiracetam or placebo, doing a motor~     exercise called pinch training, and having transcranial magnetic stimulation. For TMS, a very~     brief electrical current is passed through an insulated coil wire placed on the scalp. The~     magnetic pulse travels through the scalp and skull, causing small electrical currents in the~     cortex that may cause muscle, hand, or arm twitching or it may affect movements or reflexes.~     During the study, subjects may be asked to make movements, do simple tasks or tense muscles.~     Electrical activity of the muscles will be recorded using electrodes taped to the skin over~     the muscle. For the pinch training, the subject makes a brief, brisk pinch after each beat of~     a metronome every two seconds and then completely relaxes the hand until the next beat.~      Subjects will be tested on four different days at least 72 hours apart. Each session will~     last about 3 to 4 hours.~      Approximate schedule for cortical excitability testing:~      TMS (study 1)~      Take levetiracetam or placebo~      TMS (study 2) < 60 minutes after drug or placebo~      TMS (study 3) < 120 minutes after drug or placebo~      Approximate schedule for pinch-training related changes:~      Take levetiracetam or placebo~      TMS and pinch power measurement < 60 minutes after drug or placebo~      Pinch training for 30 minutes~      TMS and pinch power measurement~      Sample schedule:~      Session 1 < LTC and cortical excitability testing~      Session 2 < Placebo and cortical excitability testing~      Session 3 < LTC and pinch-training related changes~      Session 4 < Placebo and pinch-training related changes~   "
270347|NCT00001577|"~     Hyperthermic isolated limb perfusion with melphalan alone is administered as a double~     perfusion schedule.~      These two isolates limb perfusions with melphalan are treated 3-6 weeks apart. After~     perfusion is established, the leak rate has been determined to be acceptable, and tissue~     temperatures are 38 degrees Celsius, then the melphalan is administered by slow injection~     into an arterial line over approximately 5 minutes. The perfusion with melphalan will then~     continue for 60 minutes, after which the extremity is flushed out with a total of 3 liters of~     fluid consisting initially of a saline solution. The dose of melphalan for the second~     perfusion will be increased.~      An attempt to resect the residual lesion between 6-12 weeks after the second~      interval perfusion may be made.~   "
270995|NCT00039793|"~     The purpose of this study is to develop methods for studying the effect of bodywork therapy~     on symptoms of fatigue in patients undergoing cancer chemotherapy.~   "
270236|NCT00006155|"~     SU5416, a novel antiangiogenesis agent, has been shown to be a potent and selective inhibitor~     of the tyrosine kinase activity of FlK-1 (a downstream effector of VEGF) in vitro and to~     inhibit the growth of endothelial cells. Since VEGF mRNA levels and vessel counts in tumor~     tissues have been shown to be inversely related to prognosis in ovarian cancer, SU5416 may~     prove to be a useful agent in this disease. Platinum agents currently provide the most~     effective treatment for ovarian cancer. However, ovarian cancer often becomes refractory to~     platinum therapy, leaving the patient with a poor prognosis. This is a phase I study designed~     to: a) determine a dose level of carboplatin to use in combination with an established dose~     of SU5416 for treatment of patients with platinum-refractory ovarian cancer, b) assess the~     side effect profile of SU5416 and carboplatin combination therapy, c) characterize any~     alterations in SU5416 pharmacokinetic and pharmacodynamic parameters when given in~     combination with carboplatin, d) characterize carboplatin pharmacokinetic and pharmacodynamic~     parameters when given in combination with SU5416, e) do exploratory studies to assess the~     effect of SU5416 on platinum-DNA adduct levels, f) do exploratory studies to assess any~     alterations in ERCC1 mRNA levels when carboplatin is administered with SU5416, and g) obtain~     preliminary evidence of the ability of SU5416 to reverse platinum resistance in patients with~     platinum-refractory ovarian carcinoma.~   "
270237|NCT00006071|"~     Cells in the lining of blood vessels produce various substances that cause the vessels to~     dilate (relax) and constrict (tighten), thereby regulating blood flow. In patients with high~     blood pressure and high cholesterol, the blood vessels do not dilate properly. This study~     will investigate the effects of rosiglitazone-a drug used to improve the action of insulin in~     diabetic patients-on blood flow by examining its effects on endothelin (a substance that~     causes vessel constriction), and other substances produced by the vessel-lining cells.~      Adults with blood pressure recordings of 140/90 mmHg or higher on at least three separate~     days or with a blood cholesterol level of at least 240 mg/dl may be eligible for this study.~     Candidates will be screened with a medical history and physical examination, blood pressure~     recordings, blood and urine tests.~      This crossover study involves two separate treatment periods; that is, participants will~     take either rosiglitazone or placebo (an inactive look-alike pill) once a day for 8 weeks,~     then no drug for 4 weeks, and then the alternative treatment for the next 8 weeks. Patients~     will continue to take their high blood pressure medicines during the first 6 weeks of each~     treatment period. They will stop the medication 2 weeks before the following procedures,~     which are done at the end of each 8-week treatment period:~      Strain gauge plethysmography-A small catheter is placed through a needle into an artery at~     the bend of the arm for measuring blood pressure and drawing blood samples during the study.~     Pressure cuffs are placed on the wrist and upper arm, and a strain gauge (a rubber band~     device) is placed around the forearm to measure forearm blood flow. When the cuffs are~     inflated, blood flows into the arm, stretching the strain gauge at a rate proportional to the~     flow, and the measurement is recorded.~      Small doses of four drugs-acetylcholine, bradykinin, sodium nitroprusside and BQ-123-are~     given through the catheter. Acetylcholine slows the heart rate. Bradykinin stimulates the~     release of a substance that causes blood vessels to dilate and can lower blood pressure.~     Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure~     and heart failure. BQ-123 blocks the blood vessel-constricting activity of endothelin.~      Brachial ultrasound reactivity study-A baseline ultrasound image (picture produced using~     sound waves) of the brachial artery (artery located at the bend of the arm) is taken and~     blood flow measurements are recorded. Then, a pressure cuff is placed around the upper~     forearm, inflated for 5 minutes to stop blood flow to the forearm, and then released. Images~     of the artery and flow measurements are repeated. After a 15-minute rest, new baseline images~     are taken and flow measurements obtained. A small amount of nitroglycerin is then sprayed~     under the tongue and after 3 minutes, blood flow measurements and brachial artery images are~     recorded once more.~   "
270238|NCT00006062|"~     This is a phase I study of the experimental anticancer drug oxaliplatin. It is designed to~     establish the maximum dose of the drug that can be given safely to patients with cancer who~     have impaired liver function and to determine the drug's side effects. It will also examine~     how liver function affects the drug's elimination from the body. The liver plays an important~     role in the elimination of many anticancer drugs, and patients with impaired liver function~     should not take certain drugs or should take them in reduced doses.~      Patients 18 years of age and older with cancer that has metastasized (spread from the~     original tumor site) and for whom standard treatment is not available or is no longer~     effective may be eligible for this study. Candidates will be screened with various tests and~     procedures that may include physical examination, computerized tomography (CT) or magnetic~     resonance imaging (MRI) scans, chest X-rays, and blood and urine tests.~      Participants will be given oxaliplatin in doses determined according to their level of liver~     function. Patients may have normal liver function or mildly, moderately or severely impaired~     liver function, or may have had a liver transplant. Oxaliplatin will be infused intravenously~     (through a vein) over two hours on the first day of 21-day treatment cycles-that is, once~     every 3 weeks. Treatment will continue as long as the cancer is under control and side~     effects do not require stopping the drug. Urine will be collected over 48 hours after the~     infusion to determine how much of the drug is eliminated in urine. Blood tests will be done~     to monitor safety of the treatment, and imaging studies, such as X-rays, CT and MRI scans,~     will be done periodically to evaluate the tumor's response to treatment.~      Special blood tests will also be done to study how oxaliplatin is eliminated from the body.~     With the first dose of the drug, blood samples will be collected just before the infusion~     begins, just before it ends, 15 minutes, 30 minutes, 1, 2, 4, 6, 24, 48, and 72 hours after~     the infusion, and again 1 week and 3 weeks later. Additional blood samples may be collected~     at the third treatment cycle.~   "
270239|NCT00005926|"~     This study will examine the safety and effectiveness of the drugs Gemcitabine and Herceptin,~     given in conjunction with radiation therapy, for treating patients with cancer of the~     pancreas. Gemcitabine is standard therapy for advanced pancreatic cancer. It damages tumor~     cells and may enhance the effects of radiation therapy. Herceptin is a genetically engineered~     antibody that has prevented some tumors from growing in patients with breast cancer. Because~     breast and pancreatic cancer cells share an characteristic related to how Herceptin works~     (similar HER-2/neu receptor proteins), it is thought that this drug may also inhibit growth~     of tumors of the pancreas.~      Patients with pancreatic cancer may be eligible for this study. Candidates will be screened~     with a physical examination, chest X-ray, blood tests, electrocardiogram, and computerized~     tomography (CT) scan of the chest, abdomen and pelvis. They will also have a minor surgical~     procedure called a laparoscopy to evaluate the extent of their cancer. This procedure, done~     under general anesthesia, requires an overnight hospital stay. A small incision (about 1~     inch) is made in the abdomen and a thin, flexible tube with a light and special fibers at the~     end is inserted into the opening. This device, called a laparoscope, allows the surgeon to~     see inside the abdominal cavity to evaluate the tumor and also to remove a small piece of~     tumor tissue for examination.~      Patients accepted into the study will be assigned to one of two treatment groups, according~     to whether or not their tumor can be removed with surgery. Patients will be asked to complete~     a Quality of Life Evaluation before treatment begins and again at each follow-up visit. This~     15-minute questionnaire assesses patients' feelings, their ability to carry out usual~     activities, and the effects of therapy on their general health and well being.~      Patients in both treatment groups will be given the same chemotherapy, on an outpatient basis~     unless special circumstances require hospitalization. Gemcitabine is infused over 30 to 60~     minutes through an intravenous catheter (IV)-a thin plastic tube inserted into an arm vein.~     Herceptin is then given over 30 to 90 minutes through the same IV line. Radiation therapy to~     the abdomen will start the same day, after the drugs have been administered, and will~     continue for the next 4 days. This treatment cycle-chemotherapy plus 5 days of radiation~     therapy-will be repeated each week for 6 weeks.~      Within 6 weeks after the last treatment, the patient's tumor will be evaluated with a blood~     test and CT scan of the chest, abdomen and pelvis to determine if it can be removed with~     surgery. If so, the procedure will be done under general anesthesia and will require a 7- to~     10-day hospital stay. If the tumor cannot be removed with surgery, another biopsy will be~     taken to evaluate the tumor's response to the chemotherapy and radiation treatment.~      All patients will receive additional chemotherapy beginning 6 weeks after surgery (for~     patients whose tumors were removed) or 6 weeks after radiation therapy (for patients whose~     tumors could not be removed). Gemcitabine and Herceptin will be given IV once a week for 3~     weeks followed by a week of rest. This 4-week treatment cycle will be repeated up to six~     times.~      After treatment ends, patients will be evaluated with CT scans or X-rays and blood tests~     every 3 to 4 months for the first 2 years and every 6 months thereafter to evaluate disease~     status.~   "
270240|NCT00005912|"~     This study will examine how children's bodies metabolize and eliminate the anti-fungal drug~     voriconazole. The results will yield information needed to make recommendations for safe and~     effective dosing of the drug in children. Children with reduced immune function-such as those~     receiving drugs for cancer treatment-are at high risk for serious fungal infections.~      Children between 2 and 12 years old who need treatment to prevent fungal infections may be~     eligible for this study. Candidates will be screened with a physical examination, eye~     examination, and blood and urine tests.~      Children in the study will be hospitalized for 21 days. They will receive voriconazole twice~     a day (every 12 hours) for 8 days, infused through a vein over a period of 1 to 2 hours. The~     dose will be determined based on the individual child's weight. Blood samples will be~     collected at various intervals before and after the infusions on days 1, 2, 4 and 8 to~     determine the amount of drug in the blood. On day 8, the child will have another physical and~     eye examination, as well as additional blood and urine tests. If additional treatment is~     required, voriconazole may be continued for up to day 21. (Children who require the drug for~     more than 21 days may receive it under another research protocol.) On the last day of~     treatment, the child will have another physical examination, and blood and urine tests. These~     procedures will be repeated again at 30 to 35 days following the last dose of drug. A small~     sample of blood will also be analyzed for genetic information related to the rate of~     metabolism of voriconazole-that is, how fast or slow it is cleared (eliminated) by the liver.~      Voriconazole is effective against several different fungi. It may protect children against~     serious fungal infections with fewer side effects than standard available therapy.~   "
270348|NCT00001573|"~     A dose escalation scale consisting of 5 dosage levels is being used to determine the maximum~     tolerated dose (MTD) of SU101. A minimum of 3 and a maximum of 6 patients will be enrolled at~     each dose level. MTD is defined as the dose level immediately below that at which 2 or more~     patients exhibit dose limiting toxicity.~      Each treatment cycle is 21 days. Patients receive a 96 hour continuous IV infusion of SU101~     on days 1-4.~   "
270512|NCT00049842|"~     The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no~     treatment for the prevention of fibrosis progression in adult participants with moderate to~     severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol~     treatment in protocol P02370 (NCT00039871).~   "
270241|NCT00005783|"~     Sickle cell anemia is a genetic disorder that results from a single nucleotide substitution~     in codon 6 of the beta-globin gene which, in the homozygous state, produces an abnormal~     hemoglobin that is prone to polymer formation when deoxygenated. The polymerized hemoglobin~     leads to impaired deformability and sickling of red blood cells which subsequently lodge in~     end-arterioles producing the classic and most prominent feature of the disorder, repeated~     vasoocclusive crises. Despite knowledge of the precise genetic defect for decades, only~     recently has there been therapeutic impact based upon this knowledge when a clear benefit~     from treatment with hydroxyurea, a cell cycle-specific agent administered to induce~     production of fetal hemoglobin (HbF) by stimulating gamma-globin synthesis, was reported in~     patients with sickle cell disease (SCD). The reduction in the frequency and severity of~     vasoocclusive crises seen has been attributed to the increase in HbF levels in responsive~     patients. While the majority of patients demonstrate a rise in HbF, not all such patients~     benefit from treatment. Given these results, alternative agents that also stimulate the~     production of HbF warrant investigation in the treatment of SCD. Recombinant-methionyl human~     stem cell factor (SCF) is a hematopoietic growth factor with activity on immature~     hematopoietic progenitor cells. SCF stimulates the production of HbF in vitro and in vivo,~     and this effect is attainable without the myelosuppression associated with hydroxyurea. In~     this phase I/II trial, we will administer SCF in a dose escalating fashion to patients with~     sickling disorders. Parameters to be measured are HbF levels, F cell levels, peripheral blood~     CD34 levels, frequency, duration, and severity of vasoocclusive crises, and toxicity.~   "
270242|NCT00005781|"~     This study will evaluate whether digital photography is a reliable tool for diagnosing hand~     rashes, psoriasis and unusual moles. The findings will help determine if this method can be~     used in the National Health and Nutrition Examination survey (NHANES), which monitors disease~     in the United States.~      Employees of the National Institutes of Health 19 years and older may enroll in this study.~     Participants will complete a brief questionnaire that includes information on skin type,~     history of skin conditions (moles, cancer, rashes, psoriasis), and demographic information~     such as name, age and sex. They will be examined by a dermatologist, who will note in writing~     the appearance of any hand rashes, unusual moles, or psoriasis. If any areas suspicious for~     skin cancer are found, the participant will receive this information in writing, along with~     advice about where to go for treatment.~      A total of six photographs will then be taken of the participant's arms, legs, hands and~     back. The face will not be photographed, and the participants will not be identifiable.~   "
270243|NCT00005574|"~     This study will evaluate the antibiotic gentamicin for treating patients with muscular~     dystrophy caused by a specific genetic abnormality known as a nonsense mutation. In studies~     of mice with this type of muscular dystrophy, gentamicin treatment produced positive changes~     in muscle tissue.~      Patients with Duchenne or Becker muscular dystrophy caused by nonsense mutations by may be~     eligible for this 2-week study. Before starting treatment, patients will have evaluations of~     muscle strength and general well being. Two muscle tissue samples will be taken by needle~     biopsy, under local anesthetic and sedation. Because of potential risks of hearing loss and~     kidney toxicity associated with gentamicin, patients will also have a hearing test and blood~     and urine tests for kidney function before starting treatment. (Currently, gentamicin is~     commonly prescribed for serious infections of the lungs, heart, and digestive and urinary~     tracts; adverse effects of hearing loss and kidney toxicity can occur with excessively high~     drug doses.)~      Patients will be hospitalized during drug treatment. Gentamicin will be given intravenously~     (through a vein) once a day for 14 days. Blood samples will be collected daily to monitor~     drug levels and determine dosage adjustments, if necessary. Urine samples will be collected~     to assess kidney function. Hearing tests will be done on days 7 and 10.~      On the last day of the study, hearing, kidney function, and muscle strength will be tested~     and the results compared with pre-treatment levels. Blood and muscle samples will also be~     taken again for pre-treatment comparison. Hearing, blood, urine, and muscle strength tests~     will be repeated one month after treatment ends for comparison with previous results.~   "
270244|NCT00005570|"~     This study involves the collection of blood samples from patients with immune~     thrombocytopenic purpura (ITP) to evaluate the relationship between platelet counts, blood~     levels of a hormone called thrombopoietin that controls platelet production by the bone~     marrow, and blood levels of antibodies against thrombopoietin that could interfere with the~     action of this hormone. Blood samples will also be stored if separately agreed to by the~     patient for analysis of genes that might affect platelet production. At a single outpatient~     clinic visit, patients will have a medical history taken, and blood samples drawn for~     testing. Results from this study may help further understand the control of platelet~     production in patients with ITP, and suggest new therapeutic approaches.~   "
270245|NCT00005111|"~     This study will determine the rate of sugar metabolism in the brain of patients with Fabry~     disease, a genetic disease of abnormal lipid metabolism. Compared with healthy people,~     patients with Fabry disease have increased blood flow to the brain, which may result from~     abnormal brain metabolic activity. This study will use positron emission tomography (PET) and~     magnetic resonance imaging (MRI) to compare brain sugar metabolism in eight untreated~     patients, eight patients who are receiving enzyme replacement therapy, and eight healthy~     volunteers.~      Patients with treated and untreated Fabry disease and normal volunteers may be eligible for~     this study. Participants will undergo the following two procedures:~        1. PET scan < The patient lies in the PET scanning machine. First, the chest is scanned for~          a few minutes to determine how much radiation the tissues of the chest absorb. A~          radioactive sugar called fluorodeoxyglucose (FDG) is then injected through a catheter~          (thin plastic tube placed in a vein) and the heart is scanned for about 45 minutes to~          measure the amount of FDG in the blood inside the heart. The head is then scanned for~          about 20 minutes to measure FDG in the brain. This measurement tells how much sugar the~          brain uses for energy. The procedure requires insertion of two or three catheters. A~          special facemask may be molded to the patient's head to help hold the head still during~          the scanning.~        2. MRI scan < The patient lies on a table surrounded by the scanner (a metal cylinder) for~          about 60 minutes. A strong magnetic field and radio waves are used to show images of~          structural and chemical changes in tissues.~      This study may provide information that will help explain abnormalities in Fabry disease and~     the effect of treatment on the brain.~   "
270246|NCT00005016|"~     This study will examine the experiences of parents who decided to continue a pregnancy after~     receiving a prenatal diagnosis of holopresencephaly (HPE). HPE results from a genetic defect~     that can cause facial abnormalities such as cleft lip and cleft palate, learning~     disabilities, muscle weakness, problems with digestion, sleep and muscle control, and other~     disabilities. The severity of symptoms varies greatly among affected children.~      Parents whose child was diagnosed before birth with HPE may be eligible for this study. It~     involves a one-time interview that takes from about 45 to 60 minutes. The interview is~     conducted either in person or by telephone and consists of three parts, as follows:~        1. The experience of receiving the diagnosis of HPE during the pregnancy < includes general~          questions such as when and how HPE was diagnosed, what kind of information the parent~          received, the parent's reaction to the diagnosis, what genetic counseling, if any, the~          parents received, and so forth.~        2. Emotional and informational needs < includes questions about the parent's specific~          emotional and informational needs from the time of diagnosis until the baby's birth, and~          the parent's reactions to support that was given.~        3. Questionnaire < includes questions about the parent and his or her child, such as the~          parent's age, gender, marital status, and religious background, the child's age, gender,~          medical problems, and so forth. The questionnaire will be completed verbally for~          telephone interviews and in writing for in-person interviews. The interview will be~          tape-recorded and will be kept confidential.~      Information from this study will provide health professionals, including genetic counselors,~     more effective strategies for helping other parents who face similar prenatal diagnoses.~   "
270247|NCT00004851|"~     To generate a library of genes that reflect the entirety of antibody responses to hepatitis C~     virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose~     viral quasispecies has been extensively characterized. In addition to characterizing the~     sequential events in antibody formation and their relationship to the changing pattern of~     viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which~     they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress~     viral replication and to translate this to therapeutic and preventive modalities.~   "
270248|NCT00004848|"~     This protocol represents a continuation of a series of prospective studies to define the~     incidence and etiology of transfusion-associated hepatitis (TAH) and to examine the impact on~     TAH of various modifications in the selection of blood donors.~      The primary goal of the study will be to determine TAH incidence after the institution of a~     variety of interventive measures to exclude hepatitis and AIDS virus carriers: including~     surrogate assays (ALT, anti-HBc), a specific assay for the hepatitis C virus (HCV), a~     specific assay for the human immunodeficiency virus (HIV) and intensified donor questioning~     for high-risk behavior patterns. There is high probability that the exclusion of donors at~     high risk for AIDS transmission will also exclude donors at high risk for hepatitis~     transmission.~      Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a~     control population undergoing identical surgical procedures, but receiving no blood or only~     autologous blood. This control population, made possible by the recent dramatic increase in~     the amount of autologous blood utilized, will allow for a clear distinction between~     transfusion-associated hepatitis and that due to nosocomial transmission or other background~     causes of hepatocellular inflammation in cardiac surgery patients.~   "
270249|NCT00004576|"~     This study will test the effectiveness of an experimental drug called LY300164 on improving~     Parkinson's disease symptoms, such as movement impairments and tremor, as well as involuntary~     movements produced by long-term treatment with levodopa.~      Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 75~     years of age may be eligible for this 8-week study. Participants will have a complete medical~     history and physical examination, including blood tests and an electrocardiogram, and~     possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray.~      Patients will stop taking all anti-parkinsonism medications except levodopa (Sinemet) and the~     experimental drug during the study. For the first 1 to 3 days, patients will be in the~     hospital for a levodopa dose-finding procedure. For this study, levodopa is infused through~     a vein for up to 8 hours, with symptoms monitored frequently to determine the doses that will~     produce two results: 1) the dose that is less than what is needed to relieve symptoms, and 2)~     the dose that relieves symptoms, but may produce dyskinesias.~      When these dose rates are determined, patients will begin treatment in one of two groups. One~     will take LY300164 3 times a day, along with levodopa, for 3 weeks. The second group will~     take placebo tablets (a look-alike tablet with no active ingredient) and levodopa on the same~     schedule as the LY300164 group. A brief medical examination and routine blood and urine tests~     will be done weekly. The drug dose will be increased every 3 to 4 days until significant side~     effects occur or the maximal dose is reached. Patients will be closely monitored for 4 hours~     after every increase. At the end of the 3 weeks, or when the maximal dose is reached,~     patients will be readmitted to the hospital for 2 to 3 days for a second levodopa~     dose-finding study, while continuing on LY300164 or placebo. After this test, patients will~     resume taking levodopa and the experimental drug or placebo as before for another 2 weeks.~      At the end of the 2-weeks, the entire procedure will be repeated in both groups, but the~     treatments will be switched-that is, the patients who were taking LY300164 will now take~     placebo, and the patients who took placebo will now take the drug. At the end of the second 3~     weeks, the levodopa infusion procedure will be repeated once more.~      Throughout the study, parkinsonism symptoms and dyskinesias will be evaluated and blood~     samples will be drawn periodically to measure drug levels.~   "
270250|NCT00004574|"~     This study will determine whether short term intravenous infusion of vitamins A and E in~     patients with abetalipoproteinemia can reverse disease symptoms in these patients.~     Abetalipoproteinemia is an inherited metabolic defect that prevents fat-soluble vitamins,~     such as A and E, from being absorbed from the intestines into the bloodstream and from being~     secreted by the liver. The deficiencies of vitamins A and E can result in severe vision~     impairment and a gait disorder. Treatment with megadoses of these vitamins, taken by mouth,~     may delay or arrest symptoms, but many continue to progress.~      For this study, a single patient with moderately severe eye and neurological defects will be~     given essential fatty acids and fat soluble vitamins directly through a vein (intravenously)~     using FDA-approved replacements with a fat emulsion and multivitamins containing fat-soluble~     vitamins. This route of administration will bypass the digestive tract, where the absorption~     problem occurs. The infusions will be given twice a week for one month and then weekly for~     another month. Blood tests will be done weekly to measure blood lipids (fatty acids and other~     substances), cell counts, and vitamin levels. Eye and neurological examinations will be done~     once a month.~   "
270513|NCT00049829|"~     HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per~     year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures~     are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine~     the benefits of zoledronic acid in fracture reduction at both the hip and spine.~   "
270514|NCT00049816|"~     This trial will test if walking or bicycling exercise is effective as a non-surgical~     treatment option for patients with knee osteoarthritis.~   "
270996|NCT00039780|"~     The purpose of this study is to determine whether BNP7787 is effective in preventing or~     reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®).~   "
270251|NCT00004557|"~     Patients with Alzheimer's disease (AD) perform poorly on tasks dependent on access to, and~     utilization of, previously acquired knowledge and skills. It has been commonly assumed that~     impaired knowledge in AD, as well as in other patients with cortical lesions, is due to an~     actual loss or disorganization of a specific knowledge base or system. This hypothesis has,~     however, recently been called into question by data from tasks that purport to tap knowledge~     on a more automatic and implicit level. For example, although AD patients are impaired on~     object naming and verbal fluency tasks, they show a normal pattern of semantic facilitation~     on reaction time based priming tasks. In fact, the level of facilitation or activation on~     these tasks has often been reported to be greater in AD patients than in normal individuals.~     These and similar data have been used to support arguments that performance decrements in AD~     patients are due to deficits in attentional and/or retrieval processes rather than a~     degradation of knowledge stores. The central focus of this project will be to test a model of~     the semantic representations of object that predicts increased facilitation or hyperpriming~     in AD patients as a result of degraded representations. The relationship between performance~     on on-line priming tasks, visual attention and spatial processes, and explicit and implicit~     measures of memory also will be examined. In addition to normal controls, patients with~     cognitive and memory impairments, but without semantically-based naming difficulties (elderly~     depressed, Huntington's disease, Korsakoff's disease) will serve as controls for overall~     slowness of response and degree of explicit memory deficit.~   "
270252|NCT00001986|"~     This study will evaluate the safety and effectiveness of the food additive 1-octanol for~     treating essential tremor. This disorder, which is an involuntary shaking, usually of the~     hands, has no satisfactory treatment. It affects more than one of every 100 people in the~     general population, with the figure climbing to nearly 4 in every hundred among people over~     40 years old. In animal studies, 1-octanol reduced chemically induced tremors in rats. This~     study will test the effects of the accepted daily intake of 1-octanol (1 milligram per~     kilogram of body weight) on essential tremor in humans.~      Patients with essential tremor 21 years old and older who wish to enroll in this study will~     undergo eligibility screening with a medical history and physical examination that includes~     tests for thyroid, liver and kidney problems. Participants will be randomly assigned to~     receive either 1-octanol or a placebo (an inactive substance). Patients in both groups will~     have an intravenous catheter (a thin, plastic tube) placed in an arm vein for collecting~     blood samples during the study. Those in the 1-octanol group will be given a 1-octanol~     capsule; the placebo group will receive a look-alike capsule containing no active ingredient.~     Neither the patient nor the doctor will know which patients are taking 1-octanol or placebo~     until the end of the study.~      Tremors will be measured once before the catheter is placed, every 15 minutes during the~     first 2 hours after taking the capsule, twice during the third hour (30 minutes apart), and~     once again after 5 hours. The tremors are measured using procedures called accelerometry and~     surface electromyography. For these procedures, electrodes are taped to the skin; needles are~     not used. Blood samples will be collected once before taking the capsule, every 15 minutes~     for the first hour and a half after taking the capsule and again at 2 hours, 4 hours and 5~     hours after taking the capsule. Vital signs (blood pressure, pulse, and respiratory rate)~     will be measured every 15 minutes during the first 2 hours of taking the capsule, every 30~     minutes during the third hour, and again at 4 hours and 5 hours.~      Participants will stay in the hospital overnight for observation and return after 3 days for~     a follow-up physical examination, including a blood test.~   "
270253|NCT00001982|"~     Hepatitis C is a disease of the liver caused by the Hepatitis C Virus (HCV). Patients with~     hepatitis C may feel well and show no signs or symptoms of being ill. However, researchers~     would like to study the long-term effects of this disease.~      Volunteer blood donors diagnosed with chronic hepatitis C viral (HCV) and various levels of~     liver enzyme activity will be offered a complete medical evaluation and liver biopsy. The~     tests will enable researchers to provide the patients with an idea of how severe their liver~     disease is. The virus and patient will be studied in order to understand why patients with~     hepatitis C develop different levels of liver damage.~   "
270254|NCT00001977|"~     This study will examine whether enhancing the chemical acetylcholine in the brain can improve~     memory and attention. It will identify changes in brain function that occur during these~     cognitive tasks. Animal and human studies have shown that a decrease in acetylcholine may be~     responsible for some of the cognition deficits in Alzheimer's disease. Conversely, patients~     taking medications that slow the breakdown of this neurotransmitter have experienced~     improvements in memory.~      Normal volunteers and patients with Alzheimer's disease may be eligible for this study of~     functional brain imaging using positron emission tomography (PET) and magnetic resonance~     imaging (MRI). These techniques can measure brain activity and identify brain regions~     involved in memory and attention. Candidates for this study will be screened with a medical~     and psychiatric history and a physical examination including blood tests, urinalysis, chest~     X-ray, and electrocardiogram (ECG). Those enrolled will perform memory and attention tasks~     during PET and MRI studies. The cognition tasks will be repeated twice-once during infusion~     of saline (a fluid with no drug effect) through a catheter inserted into a blood vessel and~     again during infusion of physostigmine, a drug that delays the breakdown of acetylcholine.~     The PET procedure will be completed in one day; the MRI procedure will be done on two~     different days.~      During imaging, attention and memory tasks will be presented in short blocks of about~     4-minutes duration. They will be repeated in sequence up to 10 times with a few minutes~     separation. Subjects will be shown pictures of faces or other visual stimuli and asked to~     decide whether the pictures are the same or different.~      Information gained from this study may increase knowledge about how acetylcholine affects the~     brain's response to memory and attention tasks and perhaps lead to better treatments for the~     cognitive deficits in Alzheimer's disease.~   "
270255|NCT00001968|"~     This study will examine the safety of giving antiviral therapy for HIV infection in a~     once-daily dosing schedule, and assess how well patients tolerate this regimen. A once a day~     dosing schedule may be easier for some people to follow than one that requires taking~     medicine 2 or 3 times a day. The ease of treatment is important, because not following the~     prescribed dosing regimen may make therapy less effective or ineffective.~      HIV-infected patients 18 years and older who have never been treated for their infection may~     be eligible for this study. Candidates will be screened with a history and physical~     examination, including blood tests. Participants will take the following medications once a~     day: 1200 mg of amprenavir (8 capsules); 300 mg of ritonavir (3 capsules); 600 mg of abacavir~     (2 pills); and 300 mg of lamivudine (2 pills). Patients will have routine blood tests and be~     seen by a nurse or doctor, or both, at follow-up visits at weeks 2, 4, 8, 12, and 16; then~     every 8 weeks until week 48; and then every 3 months for up to 3 years. At week 2, a special~     blood test will be done over the course of a day to measure blood drug levels. For this test,~     blood samples will be drawn 8 times over a 24-hour period. A heparin lock (a device that~     allows the needle to remain in the vein) will be used to avoid multiple needle sticks.~   "
270452|NCT00001232|"~     The normal menstrual cycle is produced by a series of hormonal signals that starts with the~     release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. The hypothalamus is~     located in the brain and is often referred to as the master gland. GnRH then acts on the~     pituitary gland and causes it to release two hormones, follicle stimulating hormone (FSH) and~     lutenizng hormone (LH). LH and FSH act on the ovary and cause it to release the hormones~     directly involved in menstruation, estrogen and progesterone.~      The purpose of this research study is to evaluate the hypothalamic-pituitary-gonadal axis~     activity as measured by pituitary hormones, FSH and LH in response to intravenous doses of~     gonadotropin releasing hormone (GnRH) in menstrual cycle-related hormones.~   "
270256|NCT00001966|"~     This study will assess the effectiveness of mind-body therapy in relieving pain in patients~     with Ehlers-Danlos syndrome. This syndrome is a hereditary condition caused by a connective~     tissue defect and is often associated with chronic pain poorly controlled by medication or~     physical therapy. Mind-body therapy comprises various complementary or alternative medicine~     techniques such as meditation, guided imagery, stress management, and group psychotherapy.~      Adult patients with Ehlers-Danlos syndrome who have chronic pain may be eligible for this 4~     1/2 [Note: if the symbol is unreadable, it is four and one-half] to 5-month study. Patients~     not already enrolled in NHGRI's protocol 97-HG-0089 will undergo a history, physical~     examination, and brief interview before being accepted. Participants will attend 2-hour group~     sessions of mind-body therapy at NIH each week for at least 10 weeks. They will receive~     training in meditation, yoga breathing, guided imagery, and stress management in these~     sessions and will be asked to also practice the treatments at home each day. Patients may~     continue their regular medications and pain treatment with their private physicians during~     the course of the study.~      Participants will fill out a packet of questionnaires about their pain, health, and quality~     of life at three intervals: when they enroll in the study, at the end of treatment, and 12~     weeks after treatment ends. At these same time intervals, patients will come to NIH for a~     test of their physical ability to walk and climb stairs. Patients will keep a diary and pain~     symptoms and medications for 1 week before treatment begins and 1 week after it ends, and~     will fill out questionnaires about pain during the entire study period.~   "
270257|NCT00001965|"~     This study will examine the effectiveness of the drug cyclosporine in treating hypertrophic~     cardiomyopathy (HCM), a condition in which the heart muscle thickens. The thickened muscle~     can impair the heart's pumping action or decrease its blood supply, or both. Various~     symptoms, such as chest pain, shortness of breath, fatigue, and palpitations, may result. In~     animal studies, cyclosporine prevented heart muscle from thickening in mice that had been~     engineered to develop thick hearts.~      Patients with HCM 18 to 75 years old are screened for this study under protocol 98-H-0102 and~     this protocol. Screening tests include blood tests, echocardiogram to measure heart~     thickness, Holter monitor to record heartbeats, treadmill exercise test, and various imaging~     tests including a thallium scan, radionuclide angiography, magnetic resonance imaging (MRI),~     and cardiac catheterization to examine heart function and blood supply.~      Patients admitted to the study will be randomly assigned to take either cyclosporine tablets~     or a placebo (a look-alike tablet with no active ingredient) twice a day for 6 months. During~     a brief hospital stay at the start of the study, blood samples will be taken to measure~     cyclosporine levels. After discharge, heart rate and blood pressure will be checked and blood~     tests done during follow-up visits once a week for 2 weeks and then every two weeks until the~     end of the 6-month treatment period. At that time, patients will be hospitalized a second~     time for repeat tests to determine the effects of the drug on the heart condition. They~     include thallium scan, radionuclide angiogram, MRI, treadmill exercise test, cardiac~     catheterization, and echocardiogram. An echocardiogram and MRI will be repeated 1 year after~     the start of the study to evaluate long term effects of the drug, if any.~   "
270258|NCT00001963|"~     Nitric oxide (NO) is a soluble gas, continuously synthesized by the endothelium, that~     contributes importantly to vasodilator tone of the coronary and systemic circulations by~     activating guanylyl cyclase in vascular smooth muscle, causing relaxation. Although regional~     synthesis of NO by the endothelium contributes to local vasodilator tone, Stamler and~     co-workers have proposed that regional vascular tone may also be regulated by NO transported~     from the lungs by hemoglobin as a consequence of enhanced binding of NO to reactive thiols of~     oxygenated hemoglobin. This study is designed to determine the contribution of~     hemoglobin-transported NO to forearm microvascular dilator tone in healthy subjects at rest~     and during regional hypoxia associated with forearm exercise stress, with measurements made~     before and after regional blockade of endothelial NO synthesis. Findings in this study may be~     relevant to understanding the physiological contribution and therapeutic potential of~     hemoglobin-transported NO in the regulation of vasodilator tone in diseases and conditions~     associated with regional endothelial dysfunction and reduced endothelial NO bioactivity~     (e.g., hypertension, diabetes mellitus, hypercholesterolemia, cigarette smoking, and estrogen~     deficiency).~   "
270259|NCT00001944|"~     Tumor resistance to anti-cancer drugs is a major problem in cancer treatment. Studies have~     found that a protein (P-glycoprotein) on some cancer cells pumps chemotherapy drugs out of~     the cells, reducing treatment effectiveness. In laboratory tests, an experimental drug called~     XR9576, has blocked pumping by this protein. It is being used in this study to try to~     increase the amount of the anti-cancer drug vinorelbine, in cancer cells. Vinorelbine has~     been shown in several clinical trials to be effective against some advanced cancers,~     including breast, lung and ovarian, and is one of the drugs pumped out of tumor cells by~     P-glycoprotein.~      Patients with cancer 18 years and older may be eligible for this study. Candidates will be~     screened with tests that may include blood and urine tests, electrocardiogram,~     echocardiogram, CT scans, X-rays, and nuclear medicine studies. A tumor biopsy may be done~     for diagnostic or research purposes.~      Study participants will undergo tumor imaging with the radioactive drug Tc-99m Sestamibi.~     This drug accumulates in tumor cells and is eliminated from them in much the same way that~     some cancer drugs are eliminated from cells. The drug is injected into a vein and a series of~     pictures are taken with a gamma camera. After this baseline scan, patients will receive a~     dose of XR9576 and undergo a second scan 24 hours later. The scan will show whether XR9576~     affects the accumulation and elimination of Sestamibi in tumor cells. This procedure may~     provide a way to monitor cancers for evidence of chemotherapy resistance and show if XR9576~     can improve the effectiveness of therapy.~      At least 10 days after the baseline and XR9576 scans, patients will begin the first of 3 or~     more 21-day cycles of vinorelbine treatment. On days 1 and 8 of each cycle, patients will~     receive a 30-minute infusion of XR9576 intravenously (through a vein) followed by~     vinorelbine, infused over a 6- to 10-minute period. (In some patients, XR9576 will be~     administered before only one of the two vinorelbine dosages.)~      Physical examination, blood tests, and other procedures may be done periodically to monitor~     treatment.~   "
270273|NCT00001890|"~     Hardening of the arteries (atherosclerosis) and heart disease are much more common in men~     than in women. However, as women grow older, especially after menopause the incidence of~     atherosclerosis and heart disease increases. These findings suggest that estrogen may be~     protective and help in preventing heart disease.~      Studies of large groups of post-menopausal women suggest that hormone replacement therapy~     (therapy that includes estrogen) reduces the risk of heart disease. Estrogen causes favorable~     changes in particles that carry cholesterol in the blood stream and improves function of~     blood vessels. Estrogen may also stimulate the immune system's ability to fight off~     infections that may lead to or contribute to atherosclerosis.~      Researchers believe two specific infectious agents (Chlamydia pneumoniae and human~     cytomegalovirus) may cause damage to the lining of blood vessels resulting in inflammation~     and the development of atherosclerosis.~      The purpose of this study is to determine if estrogen treatment can change how the immune~     system responds to chronic infections, by Chlamydia pneumoniae and human cytomegalovirus, in~     postmenopausal women.~   "
270260|NCT00001940|"~     Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug~     had been studied in more than 1,900 healthy volunteers or patients with fungal infections.~     This study will test extended use of voriconazole in patients with serious fungal infections~     for which there are no approved therapies, and in patients who did not improve with or could~     not tolerate standard therapy. It will evaluate the drug's safety, effectiveness, and~     toleration in these patients.~      Patients previous enrolled in protocol 99-C-0094 who improved with voriconazole treatment are~     eligible for this study. Before beginning treatment, patients will have a physical~     examination, including blood and urine tests, and an eye examination. They may also have~     X-ray or CT imaging. Voriconazole will then be given twice a day either by infusion into a~     vein or by tablets taken by mouth for up to 12 weeks. Patients will be examined at weeks 4, 8~     and 12 of the study and one week after treatment stops. Blood and urine samples will be~     collected at each visit. An eye examination will be done at the end of the treatment period~     and at other visits if vision problems develop.~      Voriconazole is active against fungal infections and may produce fewer side effects than~     standard therapy.~   "
270261|NCT00001937|"~     Fever and infection are serious complications of cancer treatment such as bone marrow~     transplant, especially when white blood cell counts are low. When the number of white blood~     cells is below 500, the person has a condition called neutropenia and has a high risk of~     developing an infection. At the first sign of fever, antibiotics are started. However,~     antibiotics do not kill fungus germs, and fungal infections may be difficult to treat. Thus,~     the prevention of fungal infections in this population is important. The only medicine~     approved for prevention of fungal infections is fluconazole, which prevents some but not all~     types of such infections. A new antifungal medication called FK463 works against more types~     of fungal infections than fluconazole does. This study will compare the effectiveness,~     safety, and tolerance of FK463 as compared with fluconazole.~      Eight hundred patients will be enrolled in this study. They will be randomly assigned to~     receive either fluconazole or FK463. Before the medicine is begun, a physical exam as well as~     a blood sample, mouth swab, urine sample, and chest x-ray will be done. The fluconazole or~     FK463 will be administered once a day for one hour into the bloodstream through a catheter in~     the vein. Blood tests will be taken twice a week. Cultures from the blood, mouth, and urine~     will be taken throughout the study. X-rays and CT scans will only be taken if a fungal~     infection is suspected. If fever develops, blood will be drawn to check for fungi. If fever~     and neutropenia continue for more than 4 days, FK463 or fluconazole will be stopped and a~     standard medication called amphotericin B will be started.~      Both FK463 and fluconazole will be administered until white blood cell count returns to~     greater than 500 (signifying recovery from neutropenia), or up to 42 days after~     transplantation. Patients will be evaluated 4 weeks after the medicine is stopped.~   "
270262|NCT00001931|"~     Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This~     occurs as a result of destructive changes in an area of the brain responsible for making~     dopamine, the basal ganglia. Muscle tremors, rigidity of movement, shuffling footsteps,~     droopy posture, and a mask-like expression on the face characterize Parkinson's disease.~      This study is designed to determine the effects of a new drug, N-9023. The drug acts like~     dopamine and can be given through a skin patch (transdermal) for treatment of parkinsonian~     symptoms.~      The goals of this study are to find out whether N-9023 is useful in treating the signs and~     symptoms of Parkinson's disease and to determine the best dose of N-9023 that is safe and~     effective.~   "
270263|NCT00001930|"~     Huntington's disease is a chronic disorder passed on through genetic autosomal dominant~     inheritance. The condition usually begins between the ages of 30 and 50 years and it is~     characterized by involuntary movements in the face and extremities, (chorea), accompanied by~     changes in behavior and gradual loss of the mental function. The disease typically ends in a~     state of disorientation, impaired memory, judgement, and intellect (dementia).~      The objective of this study is to test the effectiveness of the drug amantadine for the~     treatment of chorea associated with Huntington's disease. Amantadine is an antiviral drug~     that has been used to treat a variety of illnesses including Parkinson's disease. Amantadine~     works by attaching to special sites called NMDA (N-methyl-D-aspartate) receptors and blocking~     the normal activity of glutamate there. Glutamate is an amino acid released by brain cells~     and has been associated with the symptoms of Parkinson's disease.~   "
270264|NCT00001929|"~     Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This~     occurs as a result of destructive changes in an area of the brain responsible for making~     dopamine, the basal ganglia. Patients with the disease experience, rigid muscles, stooped~     posture, and a shuffling-type walk (gait).~      In this study researchers plan to evaluate the effectiveness of the drug eliprodil for the~     treatment of Parkinson's Disease. Eliprodil works by blocking special receptors (NMDA) that~     are associated with the symptoms of Parkinson's Disease.~   "
270265|NCT00001928|"~     Patients with Parkinson's disease have low levels of the neurotransmitter dopamine. Dopamine~     is responsible for motor function and normal physical activity. Patients with Parkinson's~     disease typically suffer from tremors, rigid muscles, stooped postures, and walk with a~     shuffle. The drug levodopa acts as a replacement for dopamine and has been has been used~     effectively for over 30 years as treatment for Parkinsons disease. Because of its~     effectiveness, levodopa has been used to distinguish Parkinson's disease from other~     conditions that may resemble Parkinson's disease.~      Traditionally, levodopa has been given as a pill. In this study, researchers would like to~     inject levodopa directly into a vein (intravenous) in order to diagnose cases of Parkinson's~     disease. This method provides immediate results and allows doctors to adjust the dose of~     levodopa very carefully. Because the intravenous method of giving levodopa is less practical~     than oral medication, it is not an available alternative for the routine treatment of~     Parkinson's disease. However, it may be useful for faster diagnosis of the disease and for~     determining effective doses of oral medication.~   "
270266|NCT00001918|"~     In 1989 more than 1500 people who took the dietary supplement L-tryptophan for insomnia and~     depression developed eosinophilia myalgia syndrome (EMS)-a potentially fatal disease~     characterized by an excess of a type of white blood cell called eosinophils. Disease symptoms~     include fever, muscle aches and inflammation, and skin rashes. As many as 40 of the patients~     who became ill died. It is suspected that impurities in the supplements caused the disease.~     More recently, similar impurities have been detected in batches of a similar dietary~     supplement called L-5-hydroxytryptophan.~      This study is designed to learn more about EMS that develops in patients taking~     L-5-hydroxytryptophan. The study is open to patients newly diagnosed with eosinophilia~     myalgia who have taken L-5-HTP. Patients in the study will have a physical examination and~     urine and blood tests. They may also have X rays, an electrocardiogram, magnetic resonance~     imaging (MRI), and a skin test for tuberculosis. They will have a psychiatric interview, take~     a memory test, and fill out questionnaires relating to sadness and depression.~      Patients may also undergo special tests to study conduction of nerve impulses and muscle~     function.~      Samples of patients' supplements will be taken for chemical analysis.~   "
270267|NCT00001916|"~     In this study researchers would like to learn more about the low levels of bone mineral~     density seen in approximately half of women in their forties diagnosed as currently having or~     previously had depression.~      Bones are always undergoing a process of building (formation) and breakdown (resorption).~     This process is referred to as bone remodeling. When more bone is formed than resorbed, the~     density (level of calcium) in bone increases and the bones become stronger. However, if more~     bone is resorbed than formed the density of bone decreases and the bones become weak. This~     condition is called osteoporosis.~      It is unknown if women with depression have decreased bone mineral density as a result of too~     much breakdown of bone or not enough building. It is important to know the cause of low bone~     mineral density because it will influence the way a patient is treated. Medications like~     bisphosphonates are used when there is too much bone breakdown. Growth hormone replacement~     can be given in cases where there is not enough bone production. Presently, bone biopsy and a~     procedure known as histomorphometry can determine what processes are going on in bones.~      Researchers have decided to use a sample of bone (biopsy) from part of the hip bone (iliac~     crest). In addition, researchers will collect a sample of bone marrow (the soft tissue found~     in the center of bones) to tell them more about the biochemical, cellular, and molecular~     processes that may be contributing to the problem of decreased bone density in depressed~     premenopausal women.~   "
270268|NCT00001909|"~     Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow~     obstruction. Fourteen million persons (6.4%) in the United States report having asthma, and~     from 1980 to 1994 the prevalence of self-reported asthma in the United States increased by~     75%. A major factor in the pathogenesis of asthma is the development of an allergic~     inflammatory response to inhaled antigens. Interleukin-4 (IL-4) plays a key role in this~     response by promoting IgE production, upregulating IgE receptors, upregulating adhesion~     receptors such as VCAM-1, promoting Th2 cell development and increasing mucus secretion.~     Soluble recombinantly produced IL-4R (sIL-4R) has been shown to bind and inactivate IL-4,~     both in vitro and in animal models. As part of a multicenter trial, 20 subjects at the NIH~     site will receive 0.9 mg., 1.8 mg. sIL-4R or placebo once weekly for 12 weeks in a double~     blind placebo controlled study. Study drug will be delivered via the AERx aerosol drug~     delivery device. The primary objective of the study will be to evaluate efficacy as measured~     by FEV1. Secondary objectives will include changes in FVC, FEF 27-75, peak flow,~     bronchodilator usage, asthma symptoms, quality of life scores, immunologic and inflammatory~     markers, pharmacokinetics, safety and immunogenicity. The study population will consist of~     moderate to severe asthmatics on (Beta)-agonist monotherapy with an FEV1 of 50-80% of~     predicted. After 12 weeks of study drug, subjects will be followed for an additional 8 weeks.~   "
270269|NCT00001906|"~     While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection~     of the skin, has been possible for decades using live parasites, the production and storage~     of live cultures are difficult. Since inoculation occasionally leads to severe infection,~     most experts now advocate against their use. We have shown excellent protection using a~     heat-killed vaccine that combines autoclaved leishmania antigen with recombinant human~     interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants in a rhesus macaque model of~     disease. To assess the safety and immunogenicity of this vaccine in humans, we now propose a~     rhIL-12 dose escalation Phase I/II trial.~   "
270270|NCT00001904|"~     This minimal risk protocol is designed to assess the reproducibility of B-mode ultrasound~     measurements of carotid intima media thickness (IMT) when the scans are performed in CC~     Radiology and read using a computerized edge reader. Up to 20 volunteers will have two~     ultrasounds performed within a 6-month period. IMT thickness is used as a surrogate marker~     for atherosclerosis and may be of value in clinical trials.~   "
270271|NCT00001903|"~     Respiratory Syncytial Virus (RSV) infections are very common and widespread. By age 5,~     virtually everyone has been infected and developed antibodies against some strain of the~     virus. RSV infections happen during adulthood, leading to common cold syndromes. In Bone~     Marrow Transplant recipients the disease is much more severe, usually progressing to~     pneumonia. This phenomenon is associated with mortality rates around 60-80%.~      RSV Polyclonal Immunoglobulin (Respigam® (Registered Trademark)) has been approved by the~     Food and Drug Administration and recommended by the American Academy of Pediatrics for~     prophylaxis of RSV disease in premature babies and children born with bronchopulmonary~     dysplasia. Furthermore, it has been used to treat RSV pneumonia in children and Bone Marrow~     Transplant recipients with encouraging results and no complications.~      Currently, no preventive strategies are available when approaching this infection among bone~     marrow transplant patients. We intend to prevent our bone marrow transplant patients from~     developing RSV pneumonia by employing the strategy already used in premature babies, i.e., by~     passive immunization with Respigam® (Registered Trademark). Our goal to evaluate the efficacy~     and safety of this strategy in such immunocompromised population.~      We believe that this will be a more reasonable approach than waiting for the infection to~     settle in and only then treating it, because optimal therapy is not currently available.~   "
270272|NCT00001891|"~     Coronary artery disease (CAD) can cause poor blood flow and supply to the heart muscle. It~     can result in irreversible damage to the heart muscle and poor function. Before treating~     patients with heart disease it is important to know how well the heart is functioning.~     Echocardiography is a diagnostic test that can measure heart function. If part of the heart~     muscle is not working properly due to previous damage, echocardiography can provide~     information about how much improvement can be expected after treatment (surgery or~     angioplasty).~      The purpose of this study is to compare the accuracy of myocardial contrast echocardiography~     (MCE) to dobutamine echocardiography to detect the potential for damaged heart muscle to be~     treated and function in patients with heart disease.~      Myocardial contrast echocardiography (MCE) does not use radioactivity. It uses sound waves~     like standard echocardiography. However, with MCE patients receive an injection of a~     contrast agent directly into the blood stream through a vein. The contrast agent, called~     Optison, is made of tiny microbubbles smaller than red blood cells. The echocardiogram can~     detect these microbubbles in the small blood vessels of the heart muscle and allow~     researchers to find areas of the heart receiving less blood flow than others.~      Echocardiography with Dobutamine does not use radioactivity. It uses sound waves, like~     standard echocardiography. During this echocardiogram patients receive doses of a medication~     called dobutamine that stimulates the heart to beat stronger and faster. Heart muscle that~     does not beat stronger after dobutamine is probably dead, usually as a result of a previous~     heart attack.~   "
270274|NCT00001889|"~     This study is designed to compare two different echocardiographic techniques in the~     evaluation of heart disease (coronary artery disease). Both tests called Myocardial Contrast~     Echocardiography with Pharmacologic Stress and Stress Echocardiography with Dobutamine, are~     performed using a standard echocardiographic machine.~      Myocardial Contrast Echocardiography (MCE) does not use radioactivity. It uses sound waves~     like standard echocardiography. However, with MCE patients receive an injection of a~     contrast agent directly into the blood stream through a vein. The contrast agent, called~     Optison, is made of tiny microbubbles smaller than red blood cells. The echocardiogram can~     detect these microbubbles in the small blood vessels of the heart muscle and allow~     researchers to find areas of the heart receiving less blood flow than others. It is important~     to observe the heart during exercise because there are changes in blood flow. Since MCE~     cannot be performed when the patient is exercising, researchers give medication (adenosine)~     that stimulates the heart and creates a situation similar to exercise.~      Stress Echocardiography with Dobutamine does not use radioactivity. It uses sound waves like~     standard echocardiography. During this echocardiogram patients receive doses of a medication~     called dobutamine that stimulates the heart to beat stronger and faster.~      The purpose of this study is to evaluate the accuracy of MCE compared to stress~     echocardiography at detecting coronary artery disease (CAD).~   "
270275|NCT00001887|"~     Asthma is the third leading cause of preventable admissions to the hospital in the United~     States. Deaths and diseases associated with asthma increase every year. Asthma is a disorder~     of airway inflammation. There are several factors thought to play a role in the process of~     inflammation.~      In this study researchers are particularly interested in studying a factors known as TNF~     (tumor necrosis factor) and the sites where this factor attaches called receptors. Another~     factor associated with receptor processing is called aminopeptidase-like protein. It may be~     involved in the relationship between TNF, it's receptors, and inflammation.~      In order to understand the relationship between these factors, researchers plan to simulate~     an allergic reaction in the lungs and airways of patients participating in the study. By~     doing this they can collect and study the factors causing airway inflammation. Samples~     collected from patients with asthma will be compared to samples from volunteers without~     asthma.~      Patients and volunteers participating in this study will not directly benefit from this~     research. However, the study may help researchers understand the causes and processes~     involved in asthma. In addition, the study may lead to the development of new treatments for~     asthma and airway inflammation.~   "
270276|NCT00001886|"~     An echocardiogram is an ultrasound technique used to gather information about the heart.~     Standard echocardiograms create images of the heart in two dimensions, thereby named 2D~     (two-dimensional) echocardiography. A new technique has been developed allowing images to be~     taken of the heart in three dimensions (real time 3D echocardiography).~      The 3D echocardiogram uses high frequency sound waves to see and record the movement and~     function of the heart muscle. The echocardiogram is taken by placing an instrument called a~     transducer against the chest wall over the heart.~      In this study patients will undergo a dobutamine stress echocardiogram. Dobutamine is drug~     that causes the heart to beat stronger and faster, similar to how it acts when exercising.~     Dobutamine allows researchers to tell if the heart is suffering from a lack of oxygen during~     exercise or other forms of stress, or if it is permanently damaged.~      The purpose of this study is to determine whether stress 3D echocardiography is feasible and~     accurate in the detection of heart disease (coronary artery disease). Results of the 3D~     echocardiogram will be compared to results from standard 2D echocardiograms.~   "
270277|NCT00001881|"~     Genetically inherited heart diseases (familial cardiomyopathies) are conditions affecting the~     heart passed on to family members through abnormalities in genetic information. These~     conditions are responsible for many heart related deaths and illnesses.~      In this study researchers hope to determine the signs and symptoms (clinical correlation)~     associated with specific genetic abnormalities causing inherited heart diseases.~      In order to do this, researchers plan to evaluate patients and family members of patients~     diagnosed with inherited heart disease. Patients participating in the study will undergo~     several tests including blood tests, electrocardiograms (EKG), and echocardiograms. Patients~     may also be asked to undergo an MRI of the heart to provide a clearer picture of it.~      Patients participating in this study may not be directly benefited by it. However,~     information gathered from the study may contribute to the medical care, treatment, and~     prevention of problems for others in the future.~   "
270278|NCT00001879|"~     Hepatitis is an inflammation of the liver. Hepatitis can be caused by an infection with a~     virus, but poisonous (toxic) substances can also cause it. Researchers have identified~     several of the viruses responsible for hepatitis, however some patients with hepatitis show~     no evidence of being infected with known hepatitis viruses. Researchers call conditions like~     this, seronegative hepatitis. It means that a patient has hepatitis but he/she does not have~     evidence in their blood of a viral infection.~      Seronegative hepatitis is often complicated by autoimmune disorders and associated severe~     disorders especially, fulminant hepatitis of childhood and post-hepatitis aplastic anemia.~      Researchers have attempted to identify the cause of these conditions but have been~     unsuccessful. Therefore, this study was developed to collect blood and stool samples from~     patients with seronegative hepatitis in order to help identify the virus responsible.~   "
270284|NCT00001816|"~     This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children.~     SBW is a virtual environment designed to link seriously ill children into an interactive~     online community where they can play games, learn about their condition, or talk with other~     ill children who are connected to the network. Our outcome evaluation of SBW will include~     assessments of pain, mood (anxious, depressed and energetic), anger, loneliness, and~     willingness to return to the NIH for treatment of children who are being treated at NIH. They~     will be assessed while engaging in normal recreational activities (in one of two available~     playrooms) and while using Starbright World. In addition, we will conduct a process~     evaluation of the implementation of Starbright World.~   "
270515|NCT00049803|"~     The initial portion of the protocol involves discontinuing any medications for cataplexy that~     the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of~     study drug or placebo over a 10-11 week period. During the trial, narcolepsy symptoms will be~     evaluated. Participants are allowed to continue using stimulant medications at constant doses~     during the study. A total of 1 to 3 daytime visits in addition to 4 overnight visits to the~     sleep center will be required to complete the study.~   "
270279|NCT00001871|"~     Hypertrophic cardiomyopathy (HCM) is a genetically inherited disease affecting the heart. It~     causes thickening of heart muscle, especially the chamber responsible for pumping blood out~     of the heart, the left ventricle. This condition can cause patients to experience symptoms of~     chest pain, shortness of breath, fatigue, and heart beat palpitations. Researchers believe~     the disease may be caused by abnormalities in the genes responsible for producing proteins of~     the heart muscle.~      Oculopharyngeal muscular dystrophy (OPMD) is another genetically inherited disease. This~     condition affects the muscles of the eyes and throat causing symptoms of weak eye movements,~     difficulty swallowing and speaking, and weakness of the arms and legs.~      In previous studies researchers have found that several patients with hypertrophic~     cardiomyopathy (HCM) also had oculopharyngeal muscular dystrophy (OPMD). Researchers are~     interested in learning more about how these two diseases are associated with each other.~      In this study, researcher plan to collect samples of muscles (skeletal muscle biopsies) from~     patients belonging to families in which several members have inherited one or both of these~     diseases. The muscle samples will be used to link the muscle abnormalities with the specific~     genetic mutations.~      Patients participating in this study may not be directly benefited by it. However,~     information gathered because of this study may be used to develop better techniques for~     diagnosing and treating these conditions.~   "
270280|NCT00001867|"~     The purpose of this study is to gain information about the course of uveitis (a type of eye~     inflammation) during pregnancy and the postpartum period (six months after delivery). Some~     reports have indicated the condition may improve or disappear without treatment during~     pregnancy and recur postpartum, requiring treatment. No systematic studies have been done,~     however, to examine a link between pregnancy and disease suppression.~      All medicines for uveitis have side effects-particularly for pregnant women, their unborn~     babies, and breast-feeding mothers. The information gained may help guide treatment decisions~     for these patients in the future.~      Women who are between 2 and 20 weeks pregnant and have had uveitis within 2 years of becoming~     pregnant will be followed monthly with an eye examination and blood tests until six months~     after giving birth. The eye examination will include dilation of the pupils to look at the~     back of the eye. Photos of the eye will be taken to record changes that occur due to uveitis.~     The blood tests will assess immune function and try to determine whether levels of hormones~     and cytokines are related to uveitis disease activity. Patients who develop an inflammation~     and significant vision loss may require treatment, possibly with eye drops or injections near~     the eye. Treatment will be decided in consultation with the patient's obstetrician.~   "
270281|NCT00001857|"~     The most common problem following a kidney transplant is the development of acute or chronic~     rejection. Rejection is the immunologic reaction in which the body refuses to accept the~     transplanted organ. The body's immune system will make destructive antibodies that will~     attempt to attack the transplanted organ.~      In order to prevent organ rejection, all patients receiving an allograft (a graft~     transplanted between genetically non-identical individuals of the same species) must take~     anti-rejection therapy. These medications function by lowering the body's natural immune~     system. Often these medications are associated with significant side effects ranging from~     infections to cancer.~      This study is designed to test whether the drug presently known as BG9588 (Antova TM) can~     reduce the incidence of organ rejection following kidney transplants in humans. More~     specifically, the study will attempt to assess the safety of BG9588 when given alone or when~     given in combination with other anti-rejection therapies. Safety will be measured by the~     amount of acute or chronic rejections, and immunological graft losses.~      Subjects for the study will be made up of non-human primates (monkeys) and humans. Up to 5~     subjects in each of the groups receiving kidney transplants will be placed on a 12 month~     course of BG9588 with or without additional anti-rejection drugs. BG9588 will be given~     intravenously (injected through a vein) prior to the transplant and then in a decreased dose~     with a decreased frequency over the year. Following the 12 months of therapy subjects may be~     eligible for additional monthly therapy.~      The long-term follow up will occur through 30 months after the last dose of BG9588. Subjects~     will undergo periodic tests and evaluations throughout the course of the study. These tests~     will assess the body's immune system and detect the presence of rejection.~   "
270282|NCT00001840|"~     This project will investigate the evolution of treated and untreated stroke in patients~     recruited from the collaborative brain stroke program between NINDS, CC, and Suburban~     Hospital. The study will use anatomical and functional imaging techniques with emphasis on~     the acute and subacute stage (less than one month) of the disease.~      As the availability of new therapeutic options for the management of acute brain stroke~     increases, the need to define the evolution of the disease becomes paramount, particularly as~     therapeutic windows, defined by known and perhaps yet undiscovered parameters, may exist.~     Defining these parameters will be based on state-of-the-art imaging technology with the~     potential of clarifying the division between ischemia (reversible damage) and infarction~     (irreversible). Measures of lesion size and distribution along with vascular morphology,~     diffusion, perfusion, flow-related, and metabolic measures will be obtained over time. We~     foresee these measurements will significantly develop our understanding of cerebral ischemia~     and introduce diagnostic and quantitative tools to guide therapy and measure its efficacy.~   "
270283|NCT00001839|"~     Approximately 40% of the patients with myelodysplastic syndrome (MDS) die as a consequence of~     their cytopenia. As in aplastic anemia, the cytopenia of MDS may be partly due to cytotoxic T~     cell activity. Immunosuppressive therapy may therefore reverse the cytopenia. In a phase II~     pilot study of anti-thymocyte globin (ATG) to treat myelodysplastic syndrome (MDS); 41% of~     patients (61% of patients with refractory anemia) have responded in terms of transfusion~     independence. Recently, Jonasova et al [32] reported a 82% substantial hematological response~     rate in 18 patients with MDS of the refractory anemia (RA) subtype treated with cyclosporine~     alone. Just over 50% of the patients in this series had MDS of the hypocellular type.~     Cyclosporine alone if indeed efficacious would be a powerful therapeutic option that could be~     readily used by hematologists in the community to treat patients with MDS. This efficacy~     needs to be proven in a larger study which includes patients with the other subtypes of MDS~     and more patients with the non-hypocellular forms of MDS (which constitute approximately 70%~     of the cases in the community). As MDS is a heterogeneous group of disorders, a randomized~     comparison with the other immunomodulating intervention of proven benefit, ATG, is~     appropriate. In this randomized study patients with MDS will receive either ATG alone or~     cyclosporine alone.~   "
270516|NCT00049790|"~     The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein~     administered in combination with paclitaxel and carboplatin to patients with non-small-cell~     lung cancer.~   "
270517|NCT00049777|"~     The purpose of this study is to evaluate the relative efficacy and safety of prophylactic~     heparin co-administration during drotrecogin alfa (activated) infusion in the treatment of~     severe sepsis in the adult.~   "
270285|NCT00001814|"~     Investigation of the causes of genetic defects relating to hereditary urologic malignancies~     will be undertaken. These rare disorders result from inherited or newly arising mutations in~     genes involved in the development and function of different organ systems. As specific~     disease syndromes are recognized and the responsible genes identified, mutations in~     individual families can be identified. Correlation of mutation sites with clinical~     information will help determine how specific gene segments encode important functional~     protein domains.~      Families with urologic malignant disorders of known or suspected genetic basis will be~     enrolled. Genetic linkage studies will include all available family members, while gene~     sequence analysis will be performed on affected individuals. Unaffected family members or~     unrelated normal individuals will serve as controls. The family members will be identified by~     the proband or proband's parent when the initial pedigree is taken. Subjects considered by~     the investigators to be appropriate for linkage studies will be invited to participate by the~     local genetics provider or by the investigators, who will then connect these members to their~     own local providers for enrollment.~      In our studies of inherited urologic malignant disorders, there may be individuals from renal~     cancer families who do not undergo clinical evaluation for the presence of an inherited~     urologic malignant disorder at the National Institutes of Health because of their health~     problems, geographical location, or personal preference. Even though these individuals do not~     undergo a clinical evaluation of their suspected inherited urologic malignant disorder at the~     National Institutes of Health, they may have rare diseases that are extremely important to~     study. Therefore, we intend to collect blood samples for genetic studies from these~     individuals to facilitate linkage analysis and disease gene identification. Samples will be~     collected either by the individual's physician and sent to NIH, or will be collected by NIH~     physicians at either the individual's off-site location or at the NIH.~   "
270286|NCT00001812|"~     In patients who are receiving intravenous high dose Interleukin-2, patients will be~     randomized into two groups: group one will receive nystatin swish and swallow immediately~     before initiation of IL-2, and the second group will receive a placebo. The patients in each~     group will be monitored and evaluated for differences in the rate and severity of development~     of oral irritation during treatment. They will also be studied for differences between the~     two groups in the number of doses of IL-2 taken.~   "
270287|NCT00001810|"~     The objective of this study is to evaluate the efficacy, safety and toleration of~     voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal~     pathogens for which there is no licensed therapy; and in the secondary treatment of systemic~     or invasive fungal infections in patients failing or intolerant to treatment with approved~     systemic antifungal agents. This trial is a Phase II multicenter, open label study~     investigating the utilization of voriconazole for the treatment of systemic or invasive~     fungal infections. Enrollment is targeted for 150 patients to be recruited from multiple~     centers. The patient population will consist of patients with proven, deeply invasive fungal~     infection for which there is no licensed therapy or if the patient is failing or intolerant~     to treatment with approved systemic antifungal agents. Voriconazole will be administered~     initially by a loading dose of 6 mg/kg q12 hours for the first two doses followed by 4 mg/kg~     q12 hours. Efficacy will be evaluated by clinical, radiological and microbiological response.~   "
270288|NCT00001805|"~     This is a phase II clinical and pharmacokinetic study of suppression of human antimouse~     (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The~     primary objective of this study is to determine the effect of Rituximab on HAMA and HATA~     response to LMB-1 administered to patients with advanced carcinoma that express the B3~     antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.~   "
270289|NCT00001797|"~     Several studies have documented an essential role for interleukin-10 (IL-10) in preventing~     prolonged and exaggerated immune responses to antigens and irritants. Psoriasis, a relatively~     common disease, is characterized by T cell-mediated inflammation in affected skin. In this~     study, the safety, tolerance, immunologic effects, and clinical activity of subcutaneous (SC)~     recombinant human (rh) IL-10 will be evaluated in patients with moderate-to-severe psoriasis.~     There will be 2 groups of patients, randomized to receive either 20 ug/kg rhIL-10 SC 3 times~     weekly (20 patients) or SC placebo (10 patients). This double-blind phase will continue for a~     total of 12 weeks and the principal evaluation will be the comparison between baseline and 12~     week Psoriasis Area Severity Index (PASI) scores. Patients will come for an initial screening~     visit at day 0, and at weeks 1, 2, 4, 6, 8, and 12, with follow-up visits at weeks 16 and 20.~      All patients will be offered rhIL-10 at 12 weeks (following the blinded portion of the study~     protocol). Patients initially receiving active medication who wish to continue rhIL-10~     therapy will be kept on the drug. This open-label portion of the study will continue for an~     additional 12 weeks. Patients continuing with active drug will be evaluated at weeks 14, 16,~     20, and 24.~      Skin disease activity and toxicity will be assessed and recorded throughout the study. In~     addition, research studies will include functional assays to assess cytokine secretion and~     immunologic function of peripheral blood cells and immunohistochemical characterization of~     the inflammatory cells in skin.~   "
270290|NCT00001790|"~     The objective of this study is to evaluate the safety, tolerance, and pharmacokinetics of~     FK463, a novel echinocandin (cell wall-active antifungal lipopeptide), as early empirical~     therapy for prevention of fungal infections in immunocompromised children. The study is~     designed as a multicenter open label, sequential dose escalation study of intravenous FK463.~     Intravenous FK463 will be administered daily as an hour infusion to patients with new onset~     of fever and neutropenia (absolute neutrophil count less than or equal to 500/mm3) who will~     be initiated onto broad spectrum empirical antibacterial therapy. The patient population~     consists of children ages 2 to 17 years of age; two age cohorts will be studied (2-12,~     13-17). Dosage levels will be 0.5mg/kg/day (not to exceed 25 mg/day), 1.0 mg/kg/day (not to~     exceed 50 mg/day), 1.5 mg/kg/day (not to exceed 75 mg/day) and 2.0mg/kg/day (not to exceed~     100mg/day). The planned sample size is 64 patients (a maximum of two replacement patients may~     be added to a given dose level and age cohort, for a total of no more than 10 patients per~     dose level and age cohort. The study will enroll no more than 80 patients). At each dosage~     level, a total of 8 patients will be enrolled into each age cohort (2-12, 13-17); a total of~     16 patients will be enrolled into each dosage level. The first group of patients will receive~     FK463 at 0.5 mg/kg/day (not to exceed 25 mg/day). The second group of patients will receive~     1.0 mg/kg/day (not to exceed 50mg/day). The third group of patients will receive 1.5~     mg/kg/day (not to exceed 75 mg/day). The fourth group of patients will receive 2.0mg/kg/day~     (not to exceed 100mg/day). Study drug will continue until recovery from neutropenia (ANC post~     nadir greater than or equal 250/mm3) or until the initiation of conventional deoxycholate~     amphotericin B or a lipid formulation of amphotericin B for empirical antifungal therapy or~     for proven fungal infection. Patients may receive FK463 for a maximum duration of 14 days.~     For any patient who meets institutional criteria to start standard empirical antifungal~     therapy with conventional deoxycholate amphotericin B or a lipid formulation of amphotericin~     B (greater than 96 hours on study drug) or who has a proven breakthrough fungal infection,~     FK463 will be discontinued and conventional deoxycholate amphotericin B or a lipid~     formulation of amphotericin B will be initiated.~   "
270307|NCT00001740|"~     Quantitative measurements of left ventricular volume and ejection fraction are useful in the~     management of patients with heart disease. Several imaging methods exist, but are limited by~     cost, invasiveness, or exposure to radio-isotopes. Conventional echocardiography is a~     noninvasive method that allows estimation of left ventricular size and function; however,~     quantitative measurements of volume are not widely used due to lack of reproducibility and~     inaccurate measurements. Real-time three-dimensional echocardiography is a new technique that~     can be used to derive volume measurements from a single image acquisition. We hypothesize~     that real-time three-dimensional echocardiography is an accurate method for making left~     ventricular volume measurements. We therefore propose to measure left ventricular volumes~     using real-time three-dimensional echocardiography in human subjects and correlate these~     measurements with magnetic resonance imaging, a more accurate noninvasive method for~     obtaining these measurements.~   "
270291|NCT00001789|"~     The purpose of this study is to investigate whether the experimental drug BG9588 can be used~     to treat lupus nephritis more effectively and with less toxicity than standard treatments,~     including cyclophosphamide (Cytoxan), azothioprine (Imuran) and prednisone.~      The body's immune system naturally produces antibodies to fight foreign substances like~     bacteria and viruses. In autoimmune diseases like lupus, however, the body makes antibodies~     that attack its own tissues, causing inflammation and organ damage. Lupus antibodies attack~     and damage kidney cells. BG9588 can interfere with the production of these antibodies, and~     therefore, may lessen kidney damage in people with lupus nephritis.~      This study will look at: how BG9588 enters and leaves the blood and body tissue over time;~     adverse effects of the drug; and whether treatment with BG9588 can result in less kidney~     damage than other therapies.~      Study patients will be receive a 30-minute infusion of BG9588 into a vein every two weeks for~     three doses and then once every 28 days for four doses. Patients' steroid dosage may be~     tapered; individual adjustments will be made as required.~      Patients screened for the study will undergo a physical examination, medical history, various~     blood and urine tests, as well as complete a quality of life questionnaire. Results of a~     previous kidney biopsy and chest X ray are also required. Many of these tests will be~     repeated throughout the study.~      In a previous animal study, BG9588 treatment of mice with lupus nephritis improved their~     disease and survival.~   "
270292|NCT00001782|"~     The human brain is made up of two halves called hemispheres. Each half of the brain is~     responsible for processing different kinds of information. Previous neuroimaging studies have~     shown that both the right and left hemispheres are involved when processing information given~     in American Sign Language (ASL). However, the study also showed that when processing spoken~     language, the left hemisphere was mostly involved.~      Researchers would like to find out more about how the brain processes American Sign Language~     (ASL). This study is designed to determine if the right hemisphere is necessary for normal~     understanding of ASL.~   "
270293|NCT00001777|"~     Dementia refers to a condition where there is a loss of intellectual function (cognition). It~     is usually a progressive condition that interferes with normal social and occupational~     activities.~      Patients with frontal lobe dementia (FLD) suffer from a destruction of the brain cells found~     in the frontal lobe of the brain. Loss of frontal lobe neurons can cause changes in~     personality, such as aggressiveness, agitation, and depression. In addition, patients with~     FLD may have difficulty planning tasks and may have a loss of motivation.~      Researchers believe that the cells lost in the frontal lobe of the brain are responsible for~     producing a chemical called serotonin. Serotonin is a neurotransmitter, which means it is~     used by neurons to communicate with other neurons. Researchers are inclined to believe that~     by replacing the missing serotonin, symptoms of FLD may be relieved.~      Drugs known as serotonin uptake inhibitors, help to maintain high levels of serotonin in the~     body. They have been used successfully to treat patients with depression and patients with~     violent / impulsive behaviors. Sertraline is a serotonin reuptake blocker that is relatively~     easy to give (once daily), is safer than most other serotonin reuptake blockers (very little~     effect on vital enzyme systems [cytochrome P-450]), and has few interactions with other~     drugs.~      This study is designed to test the effectiveness of Sertraline for the treatment of symptoms~     associated with FLD. Patients participating in the study will receive Sertraline for 6 weeks~     and a placebo inactive sugar pill for 6 weeks. During the study, researchers will test~     psychological and neurological functions to measure the effects of the drug.~   "
270294|NCT00001774|"~     Fabry's disease a genetic disorder (X-linked recessive) due to the absence of the enzyme~     alpha-galactosidase A. The disease is characterized by abnormal collections of glycolipids in~     cells (histiocytes) within blood vessel walls, tumors on the thighs, buttocks, and genitalia,~     decreased sweating, tingling sensations in the extremities, and cataracts. Patients with~     Fabry 's disease die from complications of the kidney, heart, or brain.~      The objective of this study is to test the belief that patients with Fabry's disease have a~     problem with blood vessels becoming larger. The walls of blood vessels contain muscles that~     when they relax the vessel becomes larger. This process is referred to as vasodilation. It is~     controlled by a substance released by cells in blood vessels called EDRF (endothelium-derived~     relaxing factor).~      Several drugs can affect vasodilation. Researchers believe some drugs may work by blocking~     the affect of EDRF. Researchers would like to test the effects of these drugs on the blood~     vessels of normal volunteers and patients with Fabry's disease.~   "
270295|NCT00001772|"~     Bipolar disorder is a mood (affective) disorder characterized by the occurrence of~     alternating feelings of excitement (mania) and depression. It is a common, but serious~     condition, and potentially life-threatening. Patients are considered to have a rapid cycling~     form of bipolar disorder if they experience four or more episodes of hypomania (mild degree~     of mania), mania, and/or depression. Approximately 20% of the patients in bipolar clinics~     have the rapid cycling form of the disorder. Therefore it can be said that RCBD is not a rare~     condition and that it can severely impair a patient. These reasons alone justify studying~     RCBD. However, researchers also believe that information gathered by studying patients with~     RCBD can be used while studying other patients with different forms of bipolar disorder.~      The purpose of this study is to screen patients diagnosed as having rapid cycling bipolar~     disorder to see if they fit the criteria for the diagnosis and to see if they would be~     interested in participating in other research studies.~      Patients will undergo diagnostic interviews, physical examination, routine blood tests, EKG~     (electrocardiogram), and complete self-rating forms as part of the screening process.~   "
270356|NCT00001538|"~     This is a randomized, double blind study of the safety and immunogenicity of APL 400-003, a~     plasmid DNA vaccine encoding the env and rev genes of HIV-1, in HIV-negative volunteers.~     Three doses of vaccine are being tested: 100, 300, and 1000 micro g. 8 volunteers per dose~     will be randomized: 6 to plasmid vaccine, and 2 to a vehicle control. Immunizations will be~     administered at day 0 and weeks 4 and 8, with a booster immunization administered at week 24.~     An additional 5 volunteers may be included in an open manner at the dose likely to be used in~     subsequent studies. The primary aims of the study are to determine: 1. the safety of APL~     400-003, as evaluated by clinical and laboratory safety parameters and 2. the immunogenicity~     of APL 400-003, as determined by a broad range of laboratory assays. Up to 33 patients~     (allowing for drop-outs) will be enrolled in the study, and volunteers will be followed for~     one year after immunization.~   "
270296|NCT00001768|"~     Recent research studies of early onset-obsessive compulsive disorder (OCD) and Tourette's~     syndrome have questioned whether autoimmunity could play a role in the development of these~     conditions. As a result, there has been an increased interest in the field of research on the~     potential involvement of autoimmunity in other psychiatric conditions like schizophrenia.~      Autoimmune conditions occur when the normal immune system of the body begins working against~     itself. The immune system recognizes cells as foreign and begins to attack them.~      There are several similarities between autoimmune diseases and schizophrenia. Genetics play~     some role in the development of both diseases. Both conditions show a similar course, and~     both conditions tend to show worsening of symptoms when exposed to stress.~      Previous research studies have shown intravenous immunoglobulin to be safe and effective when~     used in neurologic diseases involving the immune system. Presently the NIMH is testing the~     effectiveness of IVIg in OCD and Tourette's syndrome.~      Intravenous Immunoglobulin IVIg is a medication that has been used to treat diseases like~     Kawasaki disease, systemic juvenile rheumatoid arthritis, lupus nephritis, and idiopathic~     thrombocytopenic purpura. The drug modifies the body's natural immune reactions.~      This research study is a 13-week trial of intravenous immunoglobulin (IVIg) on patients~     suffering from childhood-onset schizophrenia, who have failed to respond to other therapies.~   "
270297|NCT00001763|"~     Disseminated infection with Mycobacteria avium complex (MAC) is one of the most common~     systemic bacterial infections in advanced stages of the acquired immunodeficiency syndrome~     (AIDS). Current therapy for disseminated MAC infection in HIV patients consists of multidrug~     chemotherapy regimens are often accompanied by toxicities, and many patients become~     intolerant of one or more agents. Macrolides are the essential component of successful~     therapy, yet macrolide resistant strains are being recognized with increasing frequency.~     Thus, there is an interest in identifying additional therapeutic interventions for~     disseminated MAC in HIV-infected patients. Interleukin-12 (IL-12) is a central, regulatory~     cytokine in cell-mediated immunity. IL-12 enhances the cytolytic activity of cytotoxic T and~     NK cells, and induces interferon-gamma (IFN gamma) production from T and NK cells. This~     open-label Phase I study is designed to evaluate the safety and immunologic/microbiologic~     effects of interleukin-12 administration in HIV-infected patients with concomitant~     disseminated Mycobacterium avium (MAC) infection. Fifteen patients with documented~     disseminated MAC will be randomized to receive double-blinded placebo or escalating doses of~     IL-12 in addition to anti-MAC chemotherapy and standard anti-retroviral therapy for six~     weeks. IL-12 will be administered subcutaneously, with escalating doses every month over the~     dose range of 30 ng/kg, 100 ng/kg, and 300 ng/kg, or until an individual maximum tolerated~     dose (IMTD) is reached. Should a patient receive 2 consecutive blood cultures negative for~     MAC during the course of the study at a lower dose, then he/she will not be further dose~     escalated. Those patients receiving placebo after 6 weeks will be crossed over to receive the~     full treatment course of IL-12. Each new dose or dose escalation will take place on an~     inpatient basis. Once a patient is clinically stable at a dose, the patient will be~     maintained at that dose as an outpatient for the remainder of the month. Total IL-12~     administration will not exceed 12 weeks, or 24 total doses.~   "
270298|NCT00001761|"~     The purpose of this study is to assess the safety, tolerance, and immunologic effects of~     interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is~     to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of~     Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10~     will be given either alone or in combination with standard therapeutic agents, usually~     consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to~     receive IL-10 when there is evidence of active disease. IL-10 will be administered by~     subcutaneous injection at a dose of 4 µ (Micro)g/kg/day for 28 days.~   "
270299|NCT00001759|"~     Asthma is a chronic inflammatory disease. We propose to study inflammatory changes in the~     lungs of subjects with atopic asthma of different severity in vivo using positron emission~     tomography (PET) with 2-deoxy-2-[18F]fluoro-D-glucose (FDG). It has been shown that the~     uptake of FDG as detected by PET scanning correlates with inflammation in animal models as~     well as in human disease processes such as sarcoidosis, tuberculosis and abscess formation.~     In addition, it has been shown that the inflammation associated with allergen challenge in~     patients with atopic asthma can be visualized using PET scanning with FDG. We hypothesize~     that the degree of FDG-uptake as a measure of inflammation correlates with the severity of~     asthma as determined by pulmonary function tests and clinical signs and symptoms. In~     addition, information about the spatial distribution of the inflammatory changes will be~     obtained. To compare the characteristics of the inflammation in asthma with non-asthmatic~     inflammation of the lung, the images obtained in asthmatic subjects will be compared with~     images from subjects who have inflammatory changes of the lung caused by Wegener's~     granulomatosis. Subjects with atopic asthma and non-atopic control subjects will be selected~     from the community and, if eligible for the study, undergo skin testing against common~     allergens and pulmonary function testing. Subjects with Wegener's granulomatosis will be~     selected from a large group of subjects followed with this disease at NIAID. PET scanning~     with FDG will be used to measure inflammation in the PET scanning facility at the Clinical~     Center of the NIH and the results of the scanning will be correlated with the severity of the~     disease. We expect that for the first time this methodology will permit an objective measure~     of the basic pathogenic process, the allergic inflammation, in patients with atopic asthma.~     Using this methodology it will be possible to study the efficacy of currently available~     therapies for allergic inflammation. In addition, this methodology will provide an extremely~     useful tool for the development of new therapeutic approaches to the treatment of asthma.~   "
270300|NCT00001757|"~     Invasive fungal infections are often life-threatening in persons with immunocompromise.~     Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at high risk for~     these infections. Patients undergoing bone marrow transplantation, receiving prolonged~     corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS~     are also at risk. With the use of currently approved antifungal therapy, many of these~     infections may still be associated with a high mortality. Amphotericin B in its conventional~     form, is the current standard treatment for most life-threatening fungal infections. Because~     of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B~     have been sought. Alternated agents include three lipid formulations of amphotericin B,~     fluconazole, itraconazole. Although all of these agents are associated with a decrease in~     adverse effects, their efficacy in most life-threatening fungal infections has not been shown~     to be equivalent to conventional amphotericin B.~      Voriconazole is an investigational antifungal drug currently being brought to phase III~     trials in the US. This azole has been shown active against many fungal pathogens in vitro. In~     animal models and early human trials this new agent has been shown to be effective against~     aspergillosis. It has been shown to be well-tolerated and is available in an intravenous and~     oral formulation.~      This is a non-comparative, open label study to evaluate the efficacy, safety and toleration~     of voriconazole in the treatment of invasive fungal infections. This agent will be used as~     primary therapy in those fungal infections in which no antifungal agent is currently approved~     or in patients unable to tolerate the approved agent. Voriconazole will also be used as a~     secondary treatment in those patients who have failed therapy with the primary approved agent~     or are unable to tolerate that agent or have unacceptable toxicity.~   "
270308|NCT00001738|"~     This study will look for the presence in blood of a substance called vascular endothelial~     growth factor (VEGF) in patients with uveitis (eye inflammation). It will also look for this~     substance in eye fluid samples taken from patients with uveitis who are undergoing eye~     surgery.~      Some patients with uveitis experience some vision loss during an inflammatory attack because~     of swelling (edema) in a particular area of the retina called the macula, which is involved~     in visual acuity. It may be that VEGF is involved in the development of macular edema.~      Patients with uveitis who participate in this study will have about 10 cc (2 teaspoons) of~     blood drawn to be examined for VEGF. They will also undergo a procedure called fluorescein~     angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is~     injected into the blood stream through a vein. After the dye reaches the blood vessels of the~     eye, photographs are taken of the retina.~      In addition, patients with uveitis who are undergoing eye surgery will have a tissue specimen~     (either aqueous fluid or vitreous gel) collected for examination for the presence of VEGF.~   "
270301|NCT00001754|"~     This study will determine the genes responsible for skeletal dysplasias (disorders of the~     skeleton) and short stature and define the range and type of medical problems they cause over~     time. It will investigate whether specific gene changes cause specific medical problems in~     these disorders and identify the signs and symptoms upon which their diagnoses must be based.~      Individuals with short stature or with a skeletal dysplasia known or suspected to be caused~     by a gene mutation (change) may be eligible for this study. Family members may also~     participate. Skeletal dysplasias under study include: achondroplasia, hypochondroplasia,~     achondrogenesis type II, hypochondrogenesis, Kniest dysplasia, spondyloepiphyseal dysplasias,~     Stickler syndrome; Shmid and Jansen metaphyseal dysplasias; pyknodysotosis, proximal~     symphalangism, brachydactyly types B C and E, Ellis van Creveld and related disorders,~     metatrophic chondrodysplasias, cartilage-hair hypoplasia and disorders with a skeletal~     abnormality that have not yet been defined but might be the result of a genetic defect.~      Patients will talk with two genetics specialists who will explain the study and its possible~     implications for the patient and family and answer questions. The patient's medical records~     will be reviewed, a personal and family history will be taken, and a physical examination~     will be done. Various other procedures that may be done include drawing up to 6 tablespoons~     of blood, some of which will be used for DNA (genetic) studies, X-rays, echocardiography~     (ultrasound of the heart), magnetic resonance imaging (MRI), eye examination, hearing test,~     sleep study, sperm analysis and skin biopsy (surgical removal of a small piece of skin done~     under local anesthetic). There may be additional evaluations by specialists in rheumatology,~     rehabilitation medicine and orthopedics. When the tests and examinations are completed (after~     2 to 3 days), a doctor will discuss the results with the patient. Patients whose DNA studies~     show that a gene change is responsible for their disorder will meet with a genetics nurse or~     counselor to review the results, express their feelings and ask any questions they may have.~     Patients may be asked to return to NIH every 6 months to 2 years for continued follow-up.~     Medical management will be provided primarily by the patient's own physician.~      Participating family members will be interviewed by telephone about their personal and family~     health history and will have a blood sample drawn for DNA testing. If a gene change is found~     that is responsible for the bone disorder or growth problem in the family, arrangements will~     be made for the family member to discuss the implications of the findings with a genetics~     specialist.~   "
270302|NCT00001753|"~     This study will examine the role of temperature in changing energy metabolism in human~     muscle. In order to do this, researchers will use magnetic resonance imaging (MRI) to provide~     information about how parts of muscle operate during exercise.~      Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the~     human body without the use of X-ray (radiation). In this study, MRI will be used to measure~     the temperature and energy level of specific muscles during rest and exercise. In addition,~     the muscles being tested will be heated and cooled to see if temperature directly affects~     levels of energy in muscle.~   "
270303|NCT00001752|"~     Estrogen therapy has been associated with reduced risk of coronary heart disease events in~     observational studies of postmenopausal women. Although favorable effects of estrogen on~     lipoprotein cholesterol levels probably account for much of this benefit, direct vascular~     effects (vasomotor, hemostatic, anti-inflammatory) regulated by nitric oxide (NO) may also be~     of importance. We have recently shown that vasodilator effects of estrogen in the coronary~     circulation are due to enhanced bioactivity of NO released from the endothelium. Estrogen has~     been shown to stimulate synthesis and activity of the enzyme NO synthase with enhanced NO~     synthesis in endothelial cells in culture. Because L-arginine is the natural substrate for~     the enzyme NO synthase, we propose that the combination of L-arginine and estrogen might have~     additive vasomotor, hemostatic and anti-inflammatory effects in hypercholesterolemic~     postmenopausal women.~   "
270304|NCT00001748|"~     Many patients with hematological malignancies potentially curable by bone marrow~     transplantation are not considered for transplantation because an HLA identical family or~     unrelated donor is unavailable. For these patients the only curative option is a transplant~     from a partially matched family donor. Such transplants are feasible but are less successful~     than matched sibling donor transplants. The main problems with mismatched transplants are~     graft rejection, graft-vs-host disease, and regimen-related mortality. This restricts the use~     of mismatched transplants to patients less than 45 years at high risk of dying from the~     hematological malignancy.~      This protocol evaluates a new preparative regimen designed to ensure stem cell engraftment by~     increased immunosuppression, followed by a G-CSF mobilized T cell depleted, stem cell rich,~     peripheral blood progenitor cell (PBPC) transplant from a mismatched related donor in~     patients with high risk hematological malignancies.~      This phase I study evaluates engraftment and GVHD following T cell depleted, HLA-mismatched~     PBPC transplants. Stopping rules will be used to make modifications to the protocol in the~     event of graft failure.~      The end points of the study are graft take, acute and chronic GVHD, leukemic relapse,~     transplant-related mortality, death and leukemia-free survival. Patients will be followed up~     for 5 years. It is planned to treat up to 35 patients aged between 10 and 45 years.~   "
270305|NCT00001747|"~     Black Americans tend to die more often from and have more diseases associated with heart~     disease than White Americans. The exact cause of this is unknown, but it is likely a~     combination of genetics, behavior, risk factors, strategies for education and prevention, and~     socioeconomic factors.~      Recent studies have suggested that faster biological processes in blood vessels of Black~     Americans may be the cause of increased amounts of heart disease. In addition, small blood~     vessels in Black Americans seem to be less responsive to substances that relax blood vessels,~     which may explain increased blood pressure levels.~      In this study researchers plan to study artery relaxation (dilation) in response substances~     affecting the cells lining blood vessels (endothelin). Researchers will compare the results~     of this study in black and white people to find out whether racial differences may contribute~     to increases in heart disease and heart related deaths in blacks.~   "
270306|NCT00001742|"~     A layer of cells called the endothelium line the walls of blood vessels. These cells produce~     substances that control the tone of blood vessels and thus control blood flow through the~     vessel. This regulating activity of the endothelium is dysfunctional in several diseases of~     the heart and blood vessels, including high blood pressure and high levels of cholesterol.~      Previous research has pointed toward a decrease in the action of nitric oxide (NO) as the~     cause of this abnormality. Nitric oxide is a substance produced by the cells of the~     endothelium that plays a role in the relaxation of blood vessels.~      In this project researchers plan to study blood flow through the blood vessels in patients~     forearms after receiving four different drugs: sodium nitroprusside, acetylcholine, L-NMMA,~     and aspirin. These four drugs act on the blood vessels of the forearm through different~     mechanisms. Acetylcholine and sodium nitroprusside are drugs that open the blood vessels of~     the forearm and increase blood flow through the vessel. L-NMMA is a drug that blocks~     production of nitric oxide (NO). Aspirin's role in controlling blood flow is unknown.~      Patients participating in this research study will not directly benefit from it. However, the~     study will contribute to researchers understanding of diseases of the blood vessels and~     heart.~   "
270369|NCT00001499|"~     2-Drug Combination Chemotherapy Followed by Radiotherapy. Paclitaxel, TAX, NSC-125973;~     Cisplatin, CDDP, NSC-119875; followed by chest irradiation using 4-15 MV photons.~   "
270309|NCT00001736|"~     This study will evaluate the safety and effectiveness of a new formulation of eye drops used~     to treat cystine crystals that form in the corneas of patients with cystinosis. Cystinosis is~     an inherited disease caused by a defective enzyme, in which excessive amounts of the amino~     acid cystine accumulate in the body. Among others, symptoms include poor growth and~     development of kidney failure. In addition, after 10 to 20 years, the cornea-the outside~     covering of the eye over the iris and pupils-becomes so packed with cystine crystals that~     small, painful breaks may develop.~      This corneal condition is treated with cysteamine eye drops. This study is designed to~     provide additional information about this medication that the Food and Drug Administration~     requires before approving it for marketing. The study will examine, in two separate but~     simultaneous investigations, the safety and effectiveness of a new cysteamine formulation. In~     both studies, before treatment begins, patients will have a complete eye examination, and~     photographs of the eye will be taken using a bright flash.~      Safety Study~      Children and adults currently enrolled in a cystinosis study at the National Institutes of~     Health may participate in this trial. They will receive the current cysteamine formulation in~     one eye and the new preparation in the other eye. The drops will be given every hour during~     waking hours. Patients will be observed daily for the first week of treatment and will be~     called at 2 weeks and 4 weeks to check on side effects, if any. At 6 months, they will~     undergo a repeat eye examination. Patients (or their parents) will keep a daily diary~     recording the condition of each eye.~      Effectiveness Study~      Children and adults from Ann Arbor, Michigan, LaJolla, California, and the NEI clinic may be~     enrolled in this study. Participants will receive medication as described above for the~     safety trial. They will be observed daily for the first week and will have repeat eye~     examinations, including photographs, at months 3, 6, 9 and 12 to see if the crystals have~     decreased. Patients will keep a daily diary of the condition of both eyes.~   "
270310|NCT00001735|"~     This study will evaluate the safety and effectiveness of gene therapy for patients with~     gyrate atrophy, an inherited condition in which areas of the retina-the inner lining of the~     wall of the eye-become thin. Over several decades, this degeneration of the retina causes~     tunnel vision, night blindness, and other vision problems.~      Gyrate atrophy is caused by a defect in the gene responsible for producing an enzyme,~     ornithine aminotransferase (OAT), that breaks down an amino acid called ornithine. As a~     result, excessive ornithine buildup causes the retinal thinning. Currently, this condition~     can only be treated with amino acid tablets and a very low-protein diet with limited fruits~     and vegetables and more than 2,000 calories a day from carbohydrates and fats. Some patients~     cannot maintain this diet, and they need another treatment. One possible alternative is to~     replace the defective gene with one that functions normally.~      Patients who have been followed in NEI's Ocular Genetics service may be eligible to~     participate in this study. Study patients will undergo the following gene therapy procedure:~        1. Skin biopsy-A small piece of skin is surgically removed from the patient's thigh.~        2. Gene transfer-Skin cells called keratinocytes are taken from the biopsied tissue and~          grown in the laboratory. The normal gene that produces OAT is inserted into the cells,~          causing them to produce more of the enzyme.~        3. Skin graft-Under local anesthesia, a patch of skin about 2 1/4 inches x 2 1/4 inches is~          surgically removed from the upper thigh and some of the cells with increased OAT are~          grafted back onto this area.~      Patients will be followed at 1 week and 2 weeks after the procedure, then monthly for 6~     months, again at 9 months and 1 year. Follow-up will continue at 1-year intervals in patients~     in whom the treatment is successful. During each follow-up visit patients will have 2 to 3~     tablespoons of blood drawn for tests. A small biopsy (about 1/4 inch) of transplanted cells~     will also be done at 1 week, 1 month, 3 months, 6 months, 1 year, and each year or so~     thereafter. These tests will evaluate whether the treated skin cells are producing the~     deficient OAT enzyme and, if so, how much and for how long. They will also indicate whether~     the enzyme produced is sufficient to lower ornithine blood levels. Patients will also undergo~     various eye examinations before grafting and at scheduled follow-up visits. These tests may~     include electrophysiologic (ERG) testing, fundus photographs, scanning laser ophthalmoscope,~     visual field test, fluorescein angiogram, visual acuity, and manifest reaction.~   "
270311|NCT00001731|"~     This study will examine whether cyclosporin A eye drops alleviate dry eye syndrome, a~     disorder of tear deficiency or excessive tear evaporation. The condition damages the surface~     of the eye and causes discomfort.~      Age-related dry eye syndrome may result from a problem with the immune system in which cells~     called lymphocytes infiltrate the tear glands and cause a chronic, progressive inflammatory~     process. Previous studies suggest that cyclosporin A may increase tear production or decrease~     inflammation on the surface of the eye, or both, improving dry eye symptoms.~      Patients in the study will undergo a complete eye examination, and a small tear sample will~     be collected to study tear consistency and composition. A small amount of conjunctiva (the~     clear, thin covering of the eye lining the eyelids and eyeball) will be removed to study~     substances in it that might provide information on what causes dry eye. A blood sample also~     will be taken to look for antibodies found in patients with Sjogren's syndrome, a disorder~     characterized by dryness of the mouth, eyes and other mucous membranes. Patients will also~     fill out forms providing information on the extent to which their dry eyes bother them.~      Patients will be randomly divided into two treatment groups: one will take a cyclosporin 0.1%~     eye drop emulsion; the other will take the emulsion vehicle alone-that is, the same drops but~     without the active ingredient cyclosporin. Both groups will take one drop in each eye 4 times~     a day for 2 months. Neither the patients nor the doctors will know which patients are~     receiving which medication until the study ends. All patients will also be given artificial~     teardrops to use for comfort if needed.~   "
270312|NCT00001730|"~     Thyroid cancer is typically treated with surgery, radiation or a combination of both.~     Following surgical removal of thyroid tissue patients receive thyroid hormone replacement~     medication. In addition patients undergo tests to determine the status of the disease. One of~     the tests conducted is a whole body scan using radioactive iodine to detect and locate any~     remaining cancerous thyroid tissue.~      Thyroid tissue uses iodine to make thyroid hormones (T3 and T4). In order for a radioiodine~     scan to work, cancerous thyroid tissue must be hungry for iodine. Thyroid stimulating~     hormone (TSH) produced in the pituitary gland is responsible for making thyroid tissue~     hungry for iodine. Once thyroid tissue absorbs the radioactive iodine it will be clearly~     visible on the scan and can be located for removal. However, thyroid hormone replacement~     medication tends to lower the activity of the pituitary gland and the amount of naturally~     produced TSH. So it is necessary to stop thyroid hormone replacement to increase TSH. A~     problem arises when there is a lack of thyroid hormone replacement causing patients to~     experience hypothyroidism. This condition is associated with unpleasant physical and~     emotional symptoms.~      TSH has been created in a laboratory and called Thyrogen. It is basically the same as the TSH~     produced in the human pituitary gland. However, Thyrogen increases the level of TSH in the~     body without having to stop thyroid replacement medication. Therefore patients will not~     experience hypothyroidism while preparing for a radioactive iodine scan.~      The objective of this study is to compare the activity of radioiodine (131I) in patients~     taking Thyrogen with normal thyroid activity versus patients with hypothyroid activity after~     thyroid replacement medication is withdrawn. In addition the study will provide information~     on how radioactive iodine is eliminated from the body. The study will help researchers~     understand how to give Thyrogen and radioiodine for purposes of scanning and therapeutic~     ablation (the destruction of function) of cancerous thyroid tissue.~      The study will accept patients with non-medullary thyroid cancer who are preparing for~     ablation therapy. The patients will be placed in one of two groups. Group one will receive~     Thyrogen in 2 doses 24 hours apart. Group two will receive Thyrogen in 3 doses 72 hours~     apart. The patients will undergo two 131I whole body scans: one after Thyrogen while taking~     thyroid hormone suppressive and the second after withdrawal from thyroid hormone. 131I~     ablative therapy will be given under hypothyroid conditions at the completion of the study.~   "
270345|NCT00001584|"~     Virus present in semen likely contributes substantially to the sexual transmission of HIV.~     However, the source of HIV in semen is unknown. Some evidence suggests that the prostate may~     be the source of at least some of the virus in semen. This study is designed to determine~     whether the prostate may serve as the source of virus in semen by comparing the concentration~     of HIV-1 RNA in semen donated normally, in semen obtained following prostatic massage, and in~     expressed prostatic secretions. Finding a source for semen HIV would provide important~     insights into several aspects of HIV sexual transmission. Since some drugs do not enter the~     prostate well, the finding that virus is produced in the prostate might suggest the prostate~     could serve as a reservoir for HIV, leading to the development of resistance to antiviral~     agents.~   "
270584|NCT00048061|"~     This study will compare the efficacy and safety of different treatment regimens of oral~     Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily~     supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+~     years, and the target sample size is 500+ individuals.~   "
270313|NCT00001718|"~     Electropalatography (EPG), a noninvasive device that provides specific visual output on~     tongue-palate contact, has well-established usefulness as a biofeedback tool in speech~     therapy. While EPG has also been shown to be capable of revealing the details of~     linguopalatal interactions during swallowing, its applicability in swallowing therapy has not~     been evaluated to date. This study will determine if EPG can facilitate bolus propulsion in~     patients presenting with swallowing problems of the oral phase. Seven patients with oral~     dysphagia will be selected to serve as subjects based on specific inclusion and exclusion~     criteria, and each will be custom-fitted with a pseudo-palate. Each patient will undergo four~     45-minute sessions of biofeedback training with emphasis on developing systematic~     front-to-back anchoring of the tongue against the palate during propulsion of liquid and~     semisolid boluses. Ultrasound imaging will be used to determine swallow durations and~     identify oral deficits of swallowing before the EPG biofeedback training, and to identify any~     changes that may result from the training. Quantitative measurements will also be made of the~     swallow-related EPG contact timing and pattern before and after training and compared for~     each individual subject as a function of training and bolus volume. Appropriate statistical~     analyses will be conducted.~   "
270314|NCT00001717|"~     This protocol seeks to better understand the various factors which influence an HIV infected~     individual's decision to participate in clinical research, and especially how the offer of~     payment influences the decision to participate and understanding of the risks, benefits and~     purpose of the research. Subjects will be HIV infected individuals participating in or being~     screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and~     NCI. Willing subjects will be recruited from studies that offer payment and comparable~     studies that do not pay. The primary methodology is an interview via a survey schedule. Use~     of the interview schedule will be preceded by a focus group of about 7-10 individuals and~     pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect~     to motivations, understanding, willingness to withdraw, and sociodemographics.~   "
270315|NCT00001714|"~     This project will measure magnetization transfer (MT) parameters on normal subjects using two~     novel approaches. The first is the investigation of asymmetric MT effects with respect to the~     zero or on-resonance reference point. The technique measures the difference in MT effect~     between two symmetrically positioned off-resonance MT pulses in the positive and negative~     frequency ranges. Prior research with this technique in the kidney show a difference in the~     macromolecular lineshape that correlates to a specific metabolite. The second approach,~     utilizing a subset of the acquisitions from the first approach, will test newly developed~     formulation to calculate the macromolecular fraction, or fraction of proton density that~     accounts for MT. We foresee these measurements may significantly develop our understanding of~     MT and introduce diagnostic and quantitative tools to study human tissues.~   "
270316|NCT00001705|"~     Patients with metastatic melanoma who are HLA-A201+ will be immunized with a modified peptide~     from the gp100 molecule that contains a signal sequence designed to improve peptide~     presentation by antigen presenting cells. This peptide called gp100:ES209-217 (210M) will be~     administered either alone or in combination with high or low dose IL-2. Patients will be~     evaluated for clinical response, as well as undergo studies of the immunologic response to~     the peptide immunization.~   "
270317|NCT00001699|"~     The proposed study has two specific aims 1) to gather data about treatment adherence levels~     among adolescents (11-21 years) with HIV and 2) to obtain information about the adolescents~     and mothers' health beliefs and examine their relationship to the adolescents' adherence~     levels. This pilot study is designed to gather preliminary data about the feasibility of~     using several new measures with this population. To achieve these aims, a convenience sample~     of approximately 45 adolescents with HIV will re recruited. The adolescents and their mothers~     will complete a brief questionnaire about their health beliefs. A 24-hour recall interview~     format will be used to assess the adolescents' treatment adherence to prescribed oral~     medication. The adolescent will complete recall interviews on three random days over a two~     week period. Data analysis will be primarily descriptive, but will be used to generate more~     specific hypotheses for future research studies. The long-term goal of this research is to~     better identify adolescents with HIV at risk for non-adherence and design empirically derived~     interventions to improve their adherence levels. The health beliefs measure may also be~     useful in identifying irrational beliefs about the illness or treatment that can then be~     targeted for cognitive restructing in psychological interventions.~   "
270318|NCT00001696|"~     Genistein is a natural product found in soy beans; its consumption has been associated with a~     low incidence of metastatic prostate cancer. Genistein is a known protein-tyrosine kinase~     inhibitor, and in preclinical studies it has been shown to increase cell adhesion. Increases~     in cell adhesion in vivo would phenotypically reverse the first step in the metastatic~     cascade, potentially preventing metastasis formation, and is consistent with epidemiologic~     findings. This study seeks to determine the pharmacokinetics of genistein in humans by~     administering a single dose of genistein and performing a pharmacokinetic analysis. Patients~     will be treated with two formulations of genistein (a 43% genistein preparation or a 90%~     preparation). This is a phase I study, and patients will be treated on one of three dosing~     levels. Patients will be randomly assigned to receive one formulation first, followed by a~     washout period, and will then receive the second preparation (i.e. a randomized cross over~     design). Information from this study will be used to optimally design a multiple dose study~     wherein patients will be treated for longer periods of time.~   "
270319|NCT00001685|"~     This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201~     restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be~     administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with~     melanoma. The study is designed to evaluate the potential therapeutic role, immunologic~     effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.~      Immune reactivity to the peptide epitope will be monitored in all patients by analysis of~     melanoma-specific T cell precursors prior to and after immunization.~   "
270582|NCT00048087|"~     Patients will receive 250 mg Iressa by mouth daily each day while on this study. Patients~     will also receive docetaxel 30 mg/m2 by by vein (IV) on day 1 weekly for the first 3 weeks of~     each course of therapy. A course of therapy is 4 weeks. Patients will not receive docetaxel~     during week 4. A maximum of 8 full cycles of docetaxel plus Iressa are planned. Patients may~     continue on daily Iressa until progressive disease and/or unacceptable toxicity.~   "
270320|NCT00001681|"~     The factors that influence HIV disease progression are not well understood. While larger~     amounts of circulating virus (high 'viral loads') predict future adverse clinical events,~     many of the clinical factors responsible for high viral loads and disease progression remain~     unknown. Certain clinical events and defined interventions are associated with increases in~     plasma viral RNA concentrations. One of these clinical interventions is immunization;~     immunization with several vaccines have been shown to increase plasma HIV RNA concentrations.~     Even though vaccination can lead to transient increases in plasma HIV concentrations, certain~     vaccines, including influenza vaccine, are still recommended for HIV patients because the~     risks of the disease targeted by the immunization are held to be greater than the~     immunization itself. Therefore, immunization with influenza vaccine can be considered a~     model, clinically indicated intervention, given at a known time which stimulates HIV~     replication. For influenza immunization, and for other treatments leading to increases in~     viral RNA concentrations is not available. We hypothesize that immunization with influenza~     vaccine, and perhaps other immune stimulatory events, lead to an increase in HIV replication~     through a regulatory system involving cytokines, signal transduction systems, transcription~     factors, effects on the cell cycle, and increased expression of additional gene products~     needed for viral replication, such as genes of the nucleic acid biosynthetic pathways. While~     experiments aimed at investigating one or another particular part of this regulatory system~     can be performed with traditionally available technologies, such technologies cannot provide~     comprehensive information concerning a large number of the regulatory events that may be~     involved in mediating the increase in HIV RNA concentration. In this protocol, we aim to~     develop the methodologies needed to determine changes in expression of many of the genes~     which may be involved in mediating the regulation of HIV expression in HIV-infected patients~     using cDNA microarray technologies. Once the methodologies are developed, such work may~     provide new insights into the regulatory systems controlling HIV expression in HIV-infected~     patients may provide new insights into the pathogenesis of HIV disease.~   "
270321|NCT00001680|"~     The purpose of this double-masked, pilot trial is to determine whether 20 percent thalidomide~     ointment is safe and effective for the treatment of chronic discoid lupus erythematosus~     (CDLE) when used under an occlusive dressing. Seventeen patients with two similar lesions~     will have lesions randomized to receive either intervention or placebo therapy.~   "
270322|NCT00001679|"~     This study will evaluate the 2-5 year outcome of a cohort of 250 patients with early~     synovitis, who were recruited into protocol 94-AR-0194 (The Pathogenesis of Inflammatory~     Synovitis: A Study of Early Arthritis). Clinical, radiographic, and functional outcome~     parameters, particularly those relating to articular damage and functional loss, will be~     evaluated and related back to clinical, serologic, immunogenetic, and pathologic variables~     identified at the onset of the arthropathy. A model will be generated which incorporates and~     weighs the variables in order to determine diagnostic and prognostic markers in the early~     stages of arthritis. Synovial tissue samples have been obtained from the entire cohort at the~     initial visit of protocol 94-AR-0194. Studies of these biopsies have so far demonstrated~     evidence for the presence of infectious agents in a proportion of the samples, and have~     generated information regarding the cytokine profiles in the early stages of synovitis. In an~     attempt to further define the pathogenetic mechanisms of synovitis longitudinally, biopsies~     will be repeated on selected subsets of the cohort. Specific questions to be answered relate~     to the persistence of microbial agents in the synovium, and to the evolution of cellular and~     molecular mechanisms which mediate the invasive, destructive potential of the synovial~     lesion. It is anticipated that these studies should prove valuable to clinicians who are~     attempting to stratify patients for therapeutic strategies, early in their disease course.~     They should also prove valuable in enhancing the understanding of the pathogenetic mechanisms~     of synovitis.~   "
270323|NCT00001677|"~     The safety profile and efficacy of combination therapy will be evaluated using methotrexate~     (MTX) and the nucleoside analog fludarabine in 40 patients with severe refractory rheumatoid~     arthritis. The patients enrolled will be those who have experienced inadequate disease~     control with MTX alone or in combination with other immunosuppressive drugs such as~     sulfasalazine (SSZ), cyclosporin A (CsA), or hydroxychloroquine (HCQ). In this randomized,~     double-blind, placebo controlled trial, patients will be maintained on oral MTX at 17.5~     mg/week to which either placebo or subcutaneous fludarabine at 30 mg/m(2) daily for three~     consecutive days per month will be added for four months. The fludarabine (or placebo)~     treatment period will be followed by two months of follow-up, at which time patients will be~     evaluated for response. Patients will be monitored for adverse effects/tolerability, disease~     activity, and changes in synovial volume as measured by magnetic resonance imaging (MRI).~     Additionally synovial biopsies will be obtained before and after treatment for investigation~     of infiltrating cell numbers and phenotypes, cytokine profiles, Th1 versus Th2 responses, and~     angiogenesis.~   "
270324|NCT00001672|"~     Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately~     detailed localization of language functions in the brain. We propose to test the ability of~     rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in~     patients with temporal lobe epilepsy before and after surgical resections. The study is~     expected to yield information on the organization of language in the temporal lobes and how~     unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the~     lesioned and in the other hemisphere. It will also be a preliminary step in the development~     of a clinically useful procedure for locating critical language areas in potential surgical~     candidates.~   "
270325|NCT00001669|"~     The drug rhIGF-1 (CEP-151) has been shown to play a key role preclinically in oligodendrocyte~     differentiation and survival, as well as, myelin integrity and function. Moreover, in an~     animal model of MS, myelin expression, as well as that of its receptors is upregulated at the~     time the myelin sheaths regenerate. Finally, administration of exogenous rhIGF-1 to rats with~     EAE effectively, closes the disrupted BBB, reduces the number and severity of demyelinating~     lesions, and improves neurological function. Thus it seems reasonable to examine the efficacy~     and safety, tolerability, and effect of CEP-151 on brain MRI lesions in patients with MS.~   "
270326|NCT00001668|"~     The von Hippel Lindau (VHL) gene has recently been identified as the genetic defect resulting~     in a syndrome of multiple neoplasias. Patients with VHL disease develop retinal angiomata,~     renal cysts and/or carcinomas, CNS hemangioblastomas as well as pancreatic cysts and~     pheochromocytomas. Investigators have shown the gene to be a tumor suppressor type~     proto-oncogene located at chromosomal locus 3p26. The gene includes three exons whose gene~     product targets a cellular transcription factor Elongin SIII. Binding of the VHL proteins to~     two subunits of this elongation factor inhibits transcription and may play a crucial role in~     the clinical development of the von Hippel Lindau phenotype.~   "
270327|NCT00001667|"~     The purpose of this protocol is to identify families with inherited neurologic conditions,~     especially movement disorders, to evaluate affected and unaffected individuals clinically,~     and to obtain blood samples for genetic analysis.~   "
270585|NCT00048048|"~     This study will evaluate the efficacy and safety of different subcutaneous starting doses and~     dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on~     dialysis. The anticipated time on study treatment is 3-12 months and the target sample size~     is <100 individuals.~   "
270328|NCT00001665|"~     The problems in motor activity associated with Parkinson's disease are still poorly~     understood. Patients with Parkinson's disease often suffer from extremely slow movements~     (bradykinesia) which result in the inability to perform complex physical acts.~      Imaging studies of the brain have provided researchers with information about the specific~     areas in the brain associated with these motor difficulties. One particular area involved is~     the surface of the brain called the cerebral cortex.~      Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to~     stimulate brain activity and gather information about brain function. It is very useful when~     studying the areas of the brain related to motor activity (motor cortex, corticospinal tract,~     and corpus callosum). Repetitive transcranial magnetic stimulation (rTMS) involves the~     placement of a cooled electromagnet with a figure-eight coil on the patient's scalp and~     rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized~     stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation~     varies, depending upon the location, intensity and frequency of the magnetic pulses.~      Researchers plan to study the therapeutic effects of repetitive transcranial magnetic~     stimulation (rTMS) on complex motor behavior of patients with Parkinson's disease. In order~     to measure its effectiveness, patients will be asked to perform complex tasks, such as~     playing the piano while receiving transcranial magnetic stimulation.~   "
270329|NCT00001658|"~     Bacteria carry substances on their surface called antigens. When antigens come into contact~     with the right kinds of cells in the body an immune reaction is caused. This reaction is~     often the symptoms of sickness that a patient feels.~      In order for the body to fight off the attack of antigens, it creates substances called~     antibodies. Antibodies counter the action of antigens and make the bacteria harmless.~     However, the immune system must learn how to make the right antibodies for the right~     antigens. Sometimes the body creates antibodies that confuse normal tissues as foreign and~     attack them. This is called an autoimmune reaction and sometimes occurs when the body is~     exposed to certain bacteria.~      One bacteria known for causing autoimmune reactions is Group A beta-hemolytic Streptococcus~     (GABHS). This bacteria often causes throat infections commonly known as strep throat. Some~     researchers believe that the autoimmune reaction associated with strep throat infections may~     cause neuropsychiatric disorders, like obsessive-compulsive disorder and/or tic disorder in~     children. As a result, each time a child with one of these disorders experiences an infection~     with GABHS his/her symptoms can reoccur or worsen. Researchers believe that by giving~     patients a certain antibiotic, they can prevent GABHS infection and thus prevent the return~     of symptoms.~      This study is designed to test the effectiveness of the antibiotic Amoxicillin for the~     treatment of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal~     infections (PANDAS). Patients will receive Amoxicillin for six weeks and placebos inactive~     sugar pills for six weeks in order to see if the medication is truly working. Effectiveness~     of the treatment will be based on the presence or absence of symptoms. If at the end of the~     study Amoxicillin is proven to be effective treatment for PANDAS patients may be offered the~     opportunity to continue taking the medication for an additional six months.~   "
270330|NCT00001657|"~     Posttraumatic stress disorder occurs in patients who have experienced, witnessed or have been~     confronted with an event involving actual death or the threat of death, serious injury, or~     the threat to physical health and felt fear, helplessness, or horror. As a result, patients~     continue to re-experience, recollect, dream, or have flashbacks about the traumatic incident.~      Research on PTSD continues to show metabolic changes in specific areas of the brain in~     patients diagnosed with PTSD. For example, neuroimaging studies (functional MRI and PET~     scans) reveal that blood flow and glucose utilization increases in the right frontal, limbic,~     and paralimbic areas of the brain in patients with PTSD, particularly when they are recalling~     the traumatic event associated with their symptoms.~      One potential method for interfering with the neuronal circuitry associated with traumatic~     memories is through the use of repetitive transcranial magnetic stimulation (rTMS). This~     technique involves the placement of a cooled electromagnet with a figure-eight coil on the~     patient's scalp and rapidly turning on and off the magnetic flux. This permits non-invasive,~     relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of~     magnetic stimulation varies, depending upon the location, intensity and frequency of the~     magnetic pulses. Preliminary clinical data shows that low frequency rTMS stimulation leads to~     a decrease in regional cerebral blood flow.~      This study is designed to determine if rTMS stimulation in patients diagnosed with PTSD leads~     to symptomatic improvement, reductions in blood flow to specific areas of the brain, and~     improvements in the regulation of the autonomic nervous system.~   "
270331|NCT00001646|"~     Invasive aspergillosis is a fungal disease which is increasing in incidence with the increase~     in immunocompromised persons in our population. Persons with prolonged neutropenia secondary~     to cytotoxic chemotherapies are at the highest risk for acute aspergillosis. Patients~     undergoing bone marrow transplantation, receiving prolonged corticosteroid or other~     immunosuppressive therapies, and persons with HIV infection and AIDS are also at risk. Even~     with antifungal therapy, aspergillosis in its acute invasive forms has a high mortality. In~     bone marrow transplantation patients and in those whose infection involves the brain, this~     mortality is greater than 90%. Amphotericin B in its conventional form, is the current~     standard treatment for this disease. Response to therapy with amphotericin B usually ranges~     between 20-60% in most studies. The higher response rates are usually seen in those patients~     who can tolerate this agent for at least 14 days. Because of its nephrotoxicity and other~     adverse effects, alternatives to conventional amphotericin B have been sought. These~     currently include liposomal forms of amphotericin B and itraconazole. Although these forms~     show a decrease in adverse effects, the efficacy of these drugs has not been shown to be~     equivalent to conventional amphotericin B.~      Voriconazole is an investigational antifungal drug currently being brought to phase III~     trials in the US. This azole has been shown active against Aspergillus spp. in vitro, and in~     animal models and early human trials to be effective against aspergillosis. It has been shown~     to be well-tolerated and is available in an intravenous and oral formulation.~      This study will evaluate the efficacy, safety, and toleration of voriconazole compared to~     conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis~     in immunocompromised patients. Patients will be randomized to open-labelled therapy with~     voriconazole or amphotericin B in a one-to-one ratio.~   "
270332|NCT00001642|"~     The goal of the project is to identify and clone the gene(s) responsible for the Alagille~     Syndrome (AGS) by a positional cloning approach. The first step towards this goal is to~     define the smallest genomic candidate region for AGS at 20p12 and to begin to identify genes~     within this region which are, by definition, candidate genes for the disease. In a~     collaborative effort with clinician-investigators studying the Alagille syndrome, metaphase~     chromosomes and genomic DNA from affected individuals will be studied for subchromosomal~     deletions and for mutations in the candidate genes. Characterization of genes involved in~     Alagille syndrome could provide important insight into the pathophysiology of the disease,~     the development of normal liver and treatment of this disease. Recently, we and others found~     that mutations in Jagged1, a Notch1 receptor are responsible for Alagille Syndrome.~   "
270518|NCT00049764|"~     The purposes of this study are to determine:~        1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their~          condition more often or recover faster than children who do not receive drotrecogin alfa~          (activated).~        2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with~          severe sepsis.~        3. The side effects that might be associated with drotrecogin alfa (activated)~          administration to children with severe sepsis.~   "
270662|NCT00046566|"~     The purpose of this study is to examine the effect of dietary protein supplements on high~     blood pressure (BP).~   "
270333|NCT00001639|"~     The purpose of this research is to study a new way to test for chromosome abnormalities.~     Chromosomes are strands of DNA (the genetic material in the cell nucleus) that are made up of~     genes-the units of heredity. Chromosome abnormalities are usually investigated by staining~     the chromosomes with a dye (Giemsa stain) and examining them under a microscope. This method~     can detect many duplications and deletions of pieces of chromosomes and is very accurate in~     diagnosing certain abnormalities. It is not useful, however, for identifying very small~     abnormalities. This study will evaluate the accuracy of a test method using 24 different dyes~     for finding small chromosome abnormalities.~      Children and adults with various chromosome abnormalities may be eligible for this study,~     including, for example, people with developmental delay or mental retardation, abnormal~     growth features or growth retardation, and certain behavioral disorders. Participants will be~     evaluated in the clinic over a 1- to 3-day period, depending on their symptoms. All~     participants will be examined by a genetics specialist and will have a physical examination~     and possibly X-rays, computerized tomography (CT) scans, magnetic resonance imaging (MRI),~     ultrasound studies and medical photography. Blood will be drawn for chromosome testing-about~     3 tablespoons from adults and 1 to 3 teaspoons from children.~      When the test results are available, participants will return to the clinic for follow-up~     evaluation and review of the test findings. The genetic and medical evaluations, along with~     their implications, will be discussed.~   "
270334|NCT00001633|"~     Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the~     human body without the use of X-ray (radiation). MRI is especially useful when studying the~     arteries of the heart (CMRA, coronary magnetic resonance angiography).~      In this study researchers from several laboratories and hospitals will work together to~     determine the safety and effectiveness of CMRA with MS-325. MS-325 is a contrast agent. It is~     given to patients undergoing CRMA in order to improve the appearance of the arteries of the~     heart.~   "
270335|NCT00001629|"~     The renin angiotensin system (RAS) plays an important physiological and pathophysiological~     role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in~     the treatment of hypertension, cardiac failure and in some patients with myocardial~     infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors~     (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the~     mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce~     angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in~     the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and~     the vascular endothelium indicate that ACEI improve both endothelial dysfunction and~     metabolic coronary vasodilation, an effect that is partially mediated by bradykinin. The~     current protocol is designed to investigate whether the beneficial effects of ACEI on~     endothelial function are also partly due to inhibition of angiotensin II. The recent~     development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to~     specifically examine the effects of angiotensin II on vasomotor activity.~   "
270336|NCT00001628|"~     The renin angiotensin system (RAS) plays an important physiological and pathophysiological~     role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in~     the treatment of hypertension, cardiac failure and in some patients with myocardial~     infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors~     (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the~     mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce~     angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in~     the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and~     the vascular endothelium indicate that ACEI improve peripheral endothelial function, an~     effect that is partially mediated by bradykinin. The current protocol is designed to~     investigate whether the beneficial effects of ACEI on peripheral endothelial function are~     also due to inhibition of angiotensin II. The recent development of selective angiotensin II~     type 1 (AT1) receptor antagonists allows us to specifically examine the effects of~     angiotensin II on vasomotor activity.~   "
270337|NCT00001624|"~     Previous studies have shown that insulin may stimulate the release of endothelin (ET) from~     endothelial cells. This mechanism may contribute to the adverse vascular effects determined~     by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local~     hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess~     the forearm blood flow response to ET receptor antagonism in control conditions and during~     intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in~     response to the different pharmacological stimuli.~   "
270338|NCT00001622|"~     A layer of cells called the endothelium line the walls of blood vessels. These cells produce~     substances that control the tone of blood vessels and thus control blood flow through the~     vessel. One of the substances produced involved in the control of blood vessel function is~     nitric oxide. Nitric oxide (NO) plays a role in the relaxation of blood vessels.~      Researchers have been interested in the function of the endothelium in patients with high~     blood pressure (essential hypertension) and patients with high cholesterol~     (hypercholesterolemia).~      After conducting studies on the endothelium and nitric oxide, researchers have found that the~     endothelium is indeed functioning abnormally in patients with high blood pressure and high~     cholesterol. In addition, researchers have determined that the dysfunction is a result of~     abnormalities in the nitric oxide (NO) system.~      In this study researchers plan to investigate the relationship between blood vessel responses~     in real-life settings versus laboratory settings in normal volunteers, patients with high~     blood pressure, and patients with high cholesterol.~   "
270346|NCT00001579|"~     This is a dose escalation study.~      During the first period of this study, an initial pharmacological assessment of fluorouracil~     administered intravenously along with oral leucovorin calcium is made. Leucovorin calcium is~     given orally bid on days 1-3. Fluorouracil is given as a 24 hour infusion on day 2.~      After a 2 week rest period and resolution of any toxicities experienced during the first~     period of treatment, patients are given an escalating dose of fluorouracil with fixed doses~     of leucovorin calcium and ethynyluracil. Ethynyluracil and leucovorin calcium are given bid~     orally on days 1-3 of each week. Fluorouracil is given bid orally on day 2 of each week.~     Treatment is repeated for three weeks followed by a one week rest period.~      3 to 6 patients are enrolled at each dose level. Dose escalation proceeds until the maximum~     tolerated dose (MTD) is determined. MTD is defined as the dose preceding that at which 2 or~     more patients experience dose limiting toxicity.~   "
270339|NCT00001617|"~     This study will test the reliability of an instrument called the Quasi Elastic Laser~     Scattering Device (QLS) in detecting early changes in cataract formation.~      Surgery is currently the only treatment for cataracts. Many laboratories, however, are~     researching drugs to reverse, delay or prevent cataract formation. Anti-cataract drugs~     presumably would be most effective given early in the course of disease. When clinical trials~     of these drugs are begun, dependable and standardized methods for documenting and monitoring~     lens opacities will be needed to test their effectiveness. The QLS was designed to detect the~     earliest molecular changes in cataract development. This study will evaluate the usefulness~     and reliability of this instrument in measuring these changes.~      Normal volunteers and patients with cataracts in this study will have a standard eye~     examination, including a vision test and eye pressure measurement. The pupils will be dilated~     for QLS testing and for examination of the retina. Photographs of the retina may be taken.~     The QLS test uses a very dim laser light similar to that used to scan grocery items in the~     supermarket. The laser beam is projected into the lens of the eye, and the scattered light is~     collected and analyzed to determine normal and abnormal molecular interactions in the lens.~     Two measurements will be done for each eye. The test will be repeated in 6 months to~     determine reproducibility of the system.~   "
270340|NCT00001615|"~     Age-related macular degeneration (AMD) represents the most common cause of blindness in~     patients over the age of 60. The major cause of vision loss in this disease is due to the~     development of choroidal neovascular membrane formation (CNVM). Several clinical trials have~     proven that eyes with well-defined CNVM or lesions that can be readily demarcated with~     fluorescein angiography can be successfully treated with laser photocoagulation. However, up~     to 87% of eyes present with ill-defined CNVM or lesions that cannot be well demarcated on~     fluorescein angiography and are not amenable to laser photocoagulation. No beneficial~     treatment for this form of choroidal neovascularization has been established.~      Histopathologic study has demonstrated the presence of inflammatory and reparative responses~     in the retina of patients with ill-defined choroidal neovascularization. Since~     corticosteroids have been shown to downregulate many of the cellular factors involved in both~     inflammation and repair, the present study is designed to assess the ability of~     corticosteroid injection around the eye to prevent severe vision loss associated with~     ill-defined choroidal neovascularization in the setting of age-related macular~     degeneration. The study will be organized as a randomized open label control clinical trial~     involving 2 phases. Phase 1 involving 40 patients will establish the feasibility and safety~     of this treatment modality. Phase 2 will place emphasis on efficacy of the study.~   "
270341|NCT00001614|"~     Current treatment modalities for uveitis associated with juvenile rheumatoid arthritis have~     not been beneficial in the juvenile population. A new approach for treating patients with~     presumed autoimmune disorders is oral tolerance therapy. Chicken type II collagen (Colloral)~     is being developed as an oral tolerance therapy for the treatment of rheumatoid arthritis.~     This open label pilot study will describe the safety of chicken type II collagen added to~     current anti-inflammatory medications as treatment for patients with uveitis associated with~     juvenile rheumatoid arthritis. The primary ophthalmic outcomes of this study will be a change~     from baseline in the number of anterior chamber cells and the number and dosage of~     anti-inflammatory medications. Secondary outcomes for JRA will include change in physician's~     global assessment, parent/patient assessment of overall well-being, functional assessment,~     number of joints with active arthritis, number of joints with limited range of motion, and~     erythrocyte sedimentation rate (ESR). Secondary outcomes for uveitis will include change in~     visual acuity, vitreous haze, and anterior chamber flare.~   "
270342|NCT00001612|"~     Patients enrolled in the original Early Treatment Diabetic Retinopathy Study at the Clinical~     Center at Johns Hopkins Wilmer Eye Institute will be invited for a follow-up visit at the~     National Eye Institute. Visual function will be assessed with manifest refraction and~     standardized visual acuity measurement. The progression of retinopathy will be evaluated by~     ocular exam and fundus photography. A brief medical history will be obtained. The goal of~     this study is to evaluate the long-term results of patients whose diabetic retinopathy was~     treated with different strategies of scatter and/or focal laser photocoagulation.~   "
270343|NCT00001605|"~     Acute otitis media (OM) and OM with effusion are common childhood diseases. Otitis media is a~     condition marked by inflammation of the middle ear. Otitis media with effusion typically~     means a long-term (chronic) middle ear inflammation with secretion of fluid into the middle~     ear due to the blockage of the canal leading from the middle ear to the mouth (eustachian~     tube). The fluid involved can be sterile (no organisms) or infected with disease causing~     organisms, such as bacteria or viruses.~      Nontypeable Haemophilus influenzae (NTHi) is a bacteria that is one of the leading causes of~     OM and respiratory infections in older people. NTHi carry substances on their surface called~     antigens. When antigens come into contact with the right kinds of cells in the body, an~     immune reaction is caused. This reaction is often the symptoms of sickness that a patient~     feels. One of the major antigens on the surface of NTHi is called lipooligosaccharide (LOS).~      In order for the body to fight off the attack of antigens, it creates substances called~     antibodies. Antibodies counter the action of antigens and make the bacteria harmless.~     However, the immune system must learn how to make the right antibodies for the right~     antigens. This is done by giving vaccines.~      Vaccines can contain a small amount or an inactive form of an antigen. Once the immune system~     recognizes the antigen it can start making antibodies to prevent sickness if it is ever~     exposed to the antigen again. Presently there are no vaccines for NTHi.~      One of the reasons why there is no vaccine for NTHi is because the antigen, LOS, is very~     toxic when given to humans. Researchers have tried to make the antigen less dangerous by~     removing the toxic effects. It is referred to as dLOS. Unfortunately, dLOS is unable to start~     antibody production.~      However, researchers have found that by combining dLOS with another vaccine for tetanus~     (tetanous toxoid), they were able to stimulate the immune system to create antibodies in~     laboratory animals. These laboratory animals were protected against NTHi infections and~     otitis media (OM).~      Researchers would like to test the effectiveness and safety of dLOS-TT vaccine in adult~     humans. Their ultimate goal is to develop a vaccine for OM and respiratory infections caused~     by NTHi.~   "
270344|NCT00001587|"~     Patients with unresectable primary or metastatic cancer confined to the liver will undergo a~     1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery~     with escalating dose melphalan. Patients eligible for this protocol are those with~     non-colorectal histologies and those with colorectal cancer previously treated with~     intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of~     response, and survival will be followed.~   "
270519|NCT00049751|"~     The purpose of the study is to evaluate safety by collecting serious adverse events in~     subjects with moderately to severely active rheumatoid arthritis who are unable to obtain~     etanercept and who have failed one or more prior disease-modifying antirheumatic drugs~     (DMARDs).~   "
270520|NCT00048945|"~     The purpose of this study is to determine the safety and efficacy of Pegasys + placebo +~     lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in~     patients with hepatitis B antigen CHB.~   "
270349|NCT00001571|"~     Non-Hodgkin's lymphoma (NHL) is the third most rapidly increasing cancer in the United~     States. HIV-related NHL is responsible for some of the increase since the early 1980s.~     However, it cannot explain the steady increase in the incidence rates in earlier years, nor~     the entire increase shown recently. A possible role of environmental exposures is receiving~     attention. One possibility is that exposure to organochlorines (OCs) may be related to the~     occurrence of NHL. NCI is currently designing a large population-based case-control study to~     investigate this hypothesis further by analyzing OC levels in blood collected at the time of~     interview from cases of NHL and their matched controls. At the time of these interviews,~     cases in the main case-control study would most likely have already received chemotherapy. If~     chemotherapy changes the blood levels of OCs, this may lead to misclassification of exposure~     among cases and eventually to biased risk estimates. The purpose of this pilot study is to~     estimate the bias due to measuring the serum levels of OCs in cases during or after~     chemotherapy. Twenty newly diagnosed patients will be recruited for the study. From each~     patient, four consecutive blood samples, one prior to, two during, and one after~     chemotherapy, will be collected. Forty pairs of pre-existing cryopreserved serum samples~     (pre- and post-treatment) taken from the NHL patients who participated in an earlier NCI~     clinical study will also be included in this study. Samples will be assayed for OC levels.~     The results will be used to plan and to interpret another large case-control study (the main~     study).~   "
270350|NCT00001570|"~     Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous~     infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days. To~     ensure the safety of a 7 day infusion of PSC 833, one patient is treated for 5 days and a~     second for 6 days, before the first cohort is enrolled.~      Vinblastine is administered in escalating doses on days 2-5. At least 3 patients are entered~     at each dose level. The MTD will be defined as the dose immediately below that at which 2~     patients experience dose limiting toxicity.~      Treatment continues every 28 days.~   "
270351|NCT00001565|"~     This is a pharmacokinetic trial. Patients receive phenylbutyrate through a central venous~     catheter for each 28 day cycle. The first several days of drug administration should be~     inpatient. Cycles may be repeated if there is no tumor progression or dose limiting~     toxicities (DLT). There are no breaks between cycles.~      Once a minimum of 3 patients have completed at least 4 weeks of therapy without DLT, new~     patients will be entered at the next dose level.~   "
270352|NCT00001554|"~     It is extremely important to identify and distinguish healthy brain tissue from diseased~     brain tissue during neurosurgery. If normal tissue is damaged during neurosurgery it can~     result in long term neurological problems for the patient.~      The brain tissue as it appears prior to the operation on CT scan and MRI is occasionally very~     different from how it appears during the actual operation. Therefore, it is necessary to~     develop diagnostic procedures that can be used during the operation~      Presently, the techniques used for intraoperative mapping of the brain are not reliable in~     all cases in which they are used. Researchers in this study have developed a new approach~     that may allow diseased brain tissue to be located during an operation with little risk. This~     new approach uses nfrared technology to locate the diseased tissue and identify healthy brain~     tissue.~      The goal of this study is to investigate the clinical use of intraoperative infrared (IR)~     neuroimaging to locate diseased tissue and distinguish it from normal functioning tissue~     during the operation.~   "
270353|NCT00001553|"~     Researchers have been interested in the changes associated with motor function in humans~     after suffering a stroke. Presently, the mechanism by which a person recovers motor function~     following a stroke is poorly understood. There is little information available about the~     areas of the brain involved in the recovery of limb function.~      Recently, a new set of techniques have been developed that may be useful for reducing the~     physical impairment often associated with strokes.~      The best way to identify the areas of the brain associated with regaining function is to test~     patients before, during, and after function is regained.~      This study will compare two therapies and determine which is better at improving recovery of~     motor function. The first technique involves immobilizing the functional limb and actively~     training the affected dysfunctional limb. The second technique involves no immobilization,~     and passive movement of the affected limb.~      Results from this study will indicate which of the two therapies is better at improving motor~     function. Additional diagnostic tests will help to identify changes in brain function~     associated with recovered use of affected limbs.~   "
270354|NCT00001546|"~     Routine sleep duration varies greatly among individuals. The biological meaning of this~     variation is unknown.~      The term circadian rhythm refers to the biological clock that regulates the timing of falling~     asleep, waking up, and secretion of hormones, like melatonin. Melatonin is secreted at night.~     Previous studies have shown that melatonin may play a role in the regulation of sleep.~      The purpose of this study is to learn whether the duration of nighttime (nocturnal) melatonin~     secretion is longer in people with long regular sleep duration than people with short sleep~     duration.~      Researchers will compare levels of melatonin and cortisol, body temperature, sleepiness, and~     sleep in two extreme groups. Group one will be made up of people with short sleep duration~     lasting less than 6 hours. Group two will be made up of people with long sleep duration~     lasting more than 9 hours.~   "
270355|NCT00001540|"~     The objective of this study is to evaluate the safety and utility of bacteriophage phi X174~     immunization as a tool to assess the immune competence of HIV-infected patients at different~     stages of disease in vivo, and to assess the impact of viral load levels and therapy-induced~     changes in viral load levels on the response to immunization with the neo-antigen~     bacteriophage phi X174. Bacteriophage phi X174 immunization is a method that has been in use~     for more than 25 years to assess the immunity of patients with various types of primary and~     secondary immunodeficiencies, including 48 HIV-infected patients. This is a prospective~     open-label, controlled study which will enroll 39 HIV-infected patients and 13 healthy~     volunteers, male or female with 18 years of age and over. The HIV-infected patients will be~     divided into 3 groups according to their CD4 cell count: less than 200 cells/mm(3), between~     200 and 500 cells/mm(3) and greater than 500 cells/mm(3). After screening and a two week~     pre-study evaluation, all eligible participants will receive a primary, secondary and~     tertiary immunization with 2 x 10(9) PFU/kg of bacteriophage phi X174 six weeks apart.~     Patients who present with detectable levels of viral load at entry will be offered a more~     effective antiviral drug regimen. Patients will have to be on a stable antiviral regimen for~     at least one month prior to receiving the primary immunization. Patients will return for~     visits 1, 2 and 4 weeks after each immunization for clinical and laboratory evaluations. The~     study endpoints are: safety (as measured by incidence of adverse events, CD4 cell count and~     HIV plasma RNA), kinetics of bacteriophage clearance following primary immunization,~     quantitation of bacteriophage phi X174 specific antibody titers following primary, secondary~     and tertiary immunizations and determination of qualitative and quantitative antibody isotype~     switching following secondary and tertiary immunizations.~   "
270674|NCT00046280|"~     This is a comprehensive observational study of HIV infection in homosexual and bisexual men.~   "
270357|NCT00001536|"~     Since the gene responsible for achondroplasia was identified in 1994, it has become possible~     to test for achondroplasia prenatally. Moreover, prenatal genetic testing for achondroplasia~     is relatively simple and is highly likely to be informative for any couple seeking testing.~     Four diagnostic laboratories in the U.S. are currently performing prenatal genetic testing~     for achondroplasia. Before prenatal genetic testing for achondroplasia becomes more widely~     available, however, it is essential that we learn more about the lives of affected~     individuals and their families, the implications of offering testing for achondroplasia, and~     the education and the counseling needs of this community. Personal interviews and stories~     have been published and discussed at national meetings (Ablon 1984). We conducted a pilot~     telephone interview survey of 15 individuals with achondroplasia. What is needed now is a~     large scale quantitative study of the community of little people and their families. To meet~     this need, we have developed a survey tool to analyze family relationships, quality of life,~     tendencies toward optimism or pessimism, information-avoiding or information-seeking~     behaviors, social support, involvement in Little People of America Inc. (LPA), self-esteem,~     sociodemographics and views on achondroplasia, religiousness, reproductive and family plans,~     genetic testing, and abortion. The self-administered survey will be completed nationally by a~     sample of persons with achondroplasia and their family members.~   "
270358|NCT00001533|"~     T Cell Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders are a heterogeneous~     group of uncommon diseases which may involve a polyclonal or a monoclonal T cell population,~     which bear characteristic surface markers corresponding to activated cytotoxic (CD3+, CD8+)~     lymphocytes. They are often associated with quite severe neutropenia, anemia, and~     thrombocytopenia which may be life-threatening. There is some evidence that the abnormal~     cytotoxic lymphocyte population may cause the cytopenias by suppressing hematopoiesis,~     although the mechanism is unclear. Case reports suggest that immunosuppressive therapy~     directed toward T cells may reverse the cytopenia. This pilot study involving up to 25~     patients evaluates the clinical response to cyclosporine, an immunosuppressive drug, and~     seeks to elucidate the mechanism underlying the cytopenia.~   "
270359|NCT00001531|"~     The purpose of this study is to investigate whether the susceptibility of subjects to~     atherosclerosis is influenced by prior CMV exposure, whether the susceptability to~     endothelial dysfunction in patients with and in patients without atherosclerosis is~     influenced by prior CMV exposure.~   "
270360|NCT00001530|"~     DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most~     patients with hypertrophic cardiomyopathy (HCM). Notably, when pacing is temporarily~     discontinued, the beneficial effects of pacing are evident in sinus rhythm. The long term~     results of this novel therapy are, however, uncertain. We propose (1) to record the~     hemodynamic changes following >4 years of pacing; and (2) to determine whether DDD pacing~     continues to be necessary in patients who have had a substantial relief of their LVOT~     obstruction. Patients who have had >50% reduction in LVOT pressure gradients will be~     randomized to two pacing modalities: DDD at 70 beats per minute and AAI pacing at 70 beats~     per minute (DDD switched off), and reevaluated after a six-month period.~   "
270361|NCT00001528|"~     This study is designed to examine the blood flow, the nutrition, and the beating function of~     the heart under different conditions. Patients with narrowed coronary arteries my have~     restricted blood flow to the heart. The lowered blood supply to the heart muscle may not~     cause symptoms immediately. However, as the heart pumps faster and harder the blood supply~     demand is increased. If blood flow is unable supply enough oxygen and nutrition to heart~     muscle patients can experience symptoms of chest pain and shortness of breath. Even after the~     heart slows down and demand for oxygen and nutrition is reduced, patients can still~     experience pain and abnormal heart function.~      The purpose of this study is to determine the changes in blood flow and the beating function~     of the heart during periods of increased demands (such as exercise) and shortly after~     stopping exercise.~      Blood flow to the heart will be measured by positron emission tomography (PET scan). The PET~     scan is a test where a small amount of radioactive water is injected into the bloodstream and~     pictures of the heart are taken by the special camera. This procedure allows researchers to~     measure blood flow to heart muscle. In order to measure nutrition (metabolism) of the heart~     muscle, researchers will use a radioactive substance similar to sugar (Fluorodeoxyglucose).~      Results of this study may provide important information about the activity and function of~     heart muscle after exercise in patients suffering from coronary artery disease.~   "
270362|NCT00001527|"~     Endothelin-1 (ET-1) is a powerful vasoconstricting peptide produced predominantly by vascular~     endothelial cells, that exerts its effect through the interaction with specific receptors,~     ETA and ETB, on the underlying smooth muscle cells. Previous studies in normal subjects have~     demonstrated an increase in forearm blood flow after ET-1 antagonism, suggesting a~     physiologic role of ET-1 in the regulation of basal vascular tone. However, whether~     ET-1-mediated tone is increased in hypertensive patients is unknown.~      The main purpose of this study will be to compare the forearm vascular responses to local~     infusion of ET-1 receptor antagonists between normotensive and hypertensive subjects in order~     to assess whether ET-1-mediated basal tone is increased in patients with hypertension. In~     addition, we propose to study the vascular responses to local ET-1 infusion to determine~     whether vascular smooth muscle sensitivity to this peptide is increased in hypertensive~     vessels. We will use both an ETA receptor antagonist, BQ-123, and an ETB receptor antagonist,~     BQ-788, in order to evaluate the relative contribution of the two receptor subtypes to the~     regulation of vascular tone.~      All drugs will be infused into the brachial artery and the responses of the forearm~     vasculature will be measured by means of strain gauge plethysmography. Because of the~     relative long-lasting effect of most of the substances to be infused, the study will be~     performed on two separate occasions.~   "
270396|NCT00001435|"~     Children and adolescents with HIV/AIDS are living well beyond life expectancy that was~     projected for them in the recent past. Little is known about the psychosocial variables that~     coincide with long-term survival of HIV/AIDS. This longitudinal study examines the~     psychosocial factors and adaptive coping strategies associated with long-term survival of~     HIV/AIDS in children and how these factors change over a period of two years. In addition,~     data is being collected from the primary caretakers on their own psychological well-being as~     will as their perceptions of their child's adjustment and coping. Participants include~     children who have been infected (either perinatally or through transfusion) for at least~     eight years and who were aware of their diagnosis.~   "
270363|NCT00001523|"~     Therapeutic irradiation to the head and neck for cancer damages salivary glands present in~     the radiation field. Despite long recognition of radiation-induced salivary hypofunction, and~     the associated oral morbidities, the specific damage mechanism(s) is not known and the~     structure and functional integrity of the surviving parenchymal tissue has not been~     well-documented. Detailed knowledge of the latter is particularly necessary in order to~     design appropriate corrective therapies. It is the purpose of this study to provide such a~     detailed structural and functional assessment of human parotid glands following irradiation.~     The study will examine 20 patients beginning just prior to therapeutic irradiation and~     continuing at intervals for 3 years for a total of 5 study visits. Study visits (prior to~     irradiation and at 4 weeks, 12 weeks, 12 months and 36 months post-irradiation) will include~     the following procedures: i) detailed oral exam and structured interview; ii) salivary gland~     functional assessment; iii) sialography of each parotid gland; iv) 99mTcO4 scan of the~     salivary glands; and v) a magnetic resonance imaging (MRI) scan of the parotid glands. Based~     on previous single observation studies in humans, and more detailed animal studies, we~     hypothesize that ionizing radiation will lead to reduced parotid gland function and~     diminished salivary parenchymal tissue (with a preferential loss in acinar versus ductal~     cells). Further, we hypothesize that the parenchymal loss will increase with time (replaced~     by fat and connective tissue) and lead to progressive irreversible salivary dysfunction.~   "
270364|NCT00001520|"~     Neuromuscular blocking agents are commonly used to facilitate endotracheal intubation.~     Succinylcholine, an ultra short-acting, depolarizing neuromuscular blocking agent, is the~     most commonly used agent for paralysis in this setting because of its rapid onset and short~     duration of paralysis. In patients with contraindications to succinylcholine or in whom a~     difficult airway is anticipated, a neuromuscular blocking agent with a pharmacodynamic~     profile similar to succinylcholine would be an attractive alternative. Rocuronium, a new~     intermediate-acting nondepolarizing neuromuscular blocking agent produces paralysis within 60~     seconds, similar to succinylcholine, but has a duration of paralysis of approximately 20 to~     30 minutes. If rocuronium-induced paralysis could be chemically reversed within 10 to 15~     minutes after the administration of an intubating dose, it may be an appropriate alternative~     in patients with contraindications to succinylcholine or in patients whom a difficult airway~     is anticipated. Neostigmine is an anticholinesterase agent which inhibits the hydrolysis of~     acetylcholine by competing with acetylcholine for attachment to acetylcholinesterase.~     Inhibition of the breakdown of acetylcholine allows the neurotransmitter to be present in the~     neuromuscular junction for a longer period of time, so that each molecule can bind repeatedly~     with the acetylcholine receptor. The purpose of this study is to determine the dose of~     neostigmine necessary for the early reversal of rocuronium-induced paralysis.~   "
270365|NCT00001519|"~     Measurements of dynamic changes in oxygen uptake (VO2 kinetics) during recovery from exercise~     may describe regulatory control of oxygen transport and utilization and have greater~     reliability and less inherent risk than assessment of maximal oxygen uptake (VO2max) in~     patients for whom exercise is limited by pain, excessive fatigue, dyspnea and motivation. The~     purpose of this pilot study is to evaluate the effect of exercise intensity on the time~     constant describing changes in VO2 (tauVO2) during recovery from one minute of constant work~     rate exercise. Five normal healthy volunteers ages 18 and older will perform a progressive~     maximal aerobic exercise test, using a cycle ergometer, to determine VO2max and lactate~     threshold (LT) estimated by gas exchange. Each subject will also complete a series of maximal~     constant work rate tests and submaximal constant work rate tests at 80% LT and 50% of the~     difference between LT and VO2max (50% delta). Breath by breath variability and VO2 span will~     be used to determine the number of constant work rate test repetitions, for each subject for~     each exercise intensity, needed to establish confidence in tauVO2. A mean response profile of~     VO2 recovery kinetics for each exercise intensity will be analyzed using non-linear~     regression to determine tauVO2. To examine the effect of exercise intensity on tauVO2, one~     way analysis of variance will be used to determine whether differences exist among maximal~     and submaximal (80% LT and 50% delta) time constants. We hypothesize that there will be no~     significant differences among time constants for VO2 during recovery from maximal and~     submaximal constant work rate exercise lasting one minute. The results of this study are~     expected to provide increased understanding of the measurement of VO2 kinetics during~     recovery.~   "
270366|NCT00001518|"~     The Groshong and Groshong PICC catheters are popular venous access devices because they are~     maintained with only weekly saline flushes. In a recent study, however, we found an apparent~     decrease in the rate of withdrawal occlusion in Groshong catheters flushed weekly with~     heparinized saline. However, a randomized trial is necessary to confirm this impression. In~     the current study as many as 66 patients will be randomized to each of two treatment arms.~     The Groshong catheters of one group will be flushed with saline only and the other group with~     heparinized saline. A comparison will be made between the frequency with which urokinase is~     used in the two groups to treat withdrawal occlusion during the first three months of~     catheterization. Groshong catheters using saline flushes will be compared to Groshong~     catheters using heparinized saline flushes and Groshong PICC catheters using saline flushes~     will be compared to Groshong PICC catheters using heparinized saline flushes. Data will be~     analyzed using Fisher's exact test.~   "
270367|NCT00001509|"~     A body of preclinical data has provided a strong rationale for evaluating the combination of~     IFN-alpha with retinoic acid. The two drugs have different mechanisms of action and, when~     used in combination, show enhanced activity in both adult and pediatric tumor cell lines.~      The combination of the antiproliferative and differentiation inducing effect of retinoids~     together with the antiproliferative, immunostimulatory and differentiation-potentiating~     effects of IFN-alpha warrant clinical investigation of this combination for the treatment of~     refractory pediatric malignancies.~   "
270368|NCT00001502|"~     The presence of a highly selective blood-brain barrier (BBB) at the level of the brain~     capillary endothelium prevents chemotherapeutic agents from attaining therapeutic~     concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically~     binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially~     increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with~     preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric~     phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the~     maximum tolerated dose of RMP-7 in children with refractory brain tumors.~   "
270370|NCT00001498|"~     Stage III patients may begin therapy prior to or following surgery. Patients with undrainable~     significant third space fluid collection (e.g., pleural effusions, ascites) are entered~     directly on Consolidation.~      Patients receive induction chemotherapy with methotrexate and fluorouracil every 2 weeks for~     4 courses.~      Patients then receive two 3-week courses of consolidation therapy with cyclophosphamide,~     followed by daily granulocyte colony-stimulating factor until completion of leukapheresis.~     Patients next receive myeloablative doses of thiotepa followed by stem cell rescue and~     granulocyte colony-stimulating factor.~      After hematopoietic reconstitution, patients receive 24-hour infusions of paclitaxel every 3~     weeks for 4 doses, followed by doxorubicin or vinblastine every 3 weeks for 4 doses. Patients~     are then evaluated for additional therapy (surgery, radiotherapy, or hormonal therapy) as~     appropriate.~      Patients are followed every 3 months for 1 year, then every 6 months.~   "
270371|NCT00001497|"~     Children with symptomatic HIV-1 (Human Immunodeficiency Virus) infection are at increased~     risk for developing severely disabling neurological and neuropsychological deficits. HIV-1~     related CNS (Central Nervous System) disease is a clinical syndrome, manifested by varying~     and sometimes discordant degrees of cognitive, motor and behavioral impairment. A continuum~     of clinical presentations attributed to the effects of HIV-1 infection on the CNS, ranging~     from apparently normal development, decreases in the rate of new learning to the loss of~     acquired skills have been observed. Two domains of psychological functioning appear most~     susceptible to the effects of HIV infection on the central nervous system in children:~     expressive behavior and attentional processes (Brouwers, et al, 1994).~      Attention deficits have been documented as a relative weakness on the freedom from~     distractibility subclass of IQ tests (Brouwers et al, 1989) and on behavior assessment (Moss~     et al, 1994). Attention, however, has many subcomponents such as focused attention, divided~     attention, vigilance, etc. Direct assessment of attentional functioning using reaction time~     has not yet been conducted and questions whether attentional components are differentially~     affected by the virus have not been addressed.~      The proposed study would assess different components of attentional functioning in children~     with HIV-1 disease. A quantitative and systematic method is developed that could complement~     the existing standardized instruments used for measuring attention and neurocognitive~     function in this population. Simple alerted visual reaction time will be measured with~     varying preparatory intervals, a two-choice reaction time in a go/no-go paradigm will be~     administered, and a continuous performance, divided reaction time test and an object decision~     task will be given. Performance on these measures will also be related to measures of brain~     structure and stage of HIV-1 disease.~   "
270372|NCT00001495|"~     This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour~     drug-free intervals in patients with solid tumors in order to determine the maximum tolerated~     dose of this regimen.~   "
270373|NCT00001493|"~     This study examines the feasibility of using gene therapy to prevent some of the toxicities~     of an intensive chemotherapy regimen in patients with metastatic breast cancer. Patients who~     do not wish to participate in the gene therapy procedures will be offered identical~     chemotherapy on a different protocol. Patients will be treated initially with chemotherapy~     which is active against breast cancer, but which has a low potential to hurt blood-forming~     cells. Then, the patient will receive high dose chemotherapy, during which time blood cells~     which are capable of rebuilding patients' bone marrows will be removed from the patients'~     bloodstream. We will use these blood cell collections to isolate peripheral blood progenitor~     cells (PBPCs), those cells which are thought to be the forbears of all other blood cells.~      A portion of the PBPCs will be exposed to a disabled virus which either carries genetic~     material referred to as the multidrug resistance gene (MDR1). The virus will transfer the~     MDR1 gene into a portion of the patient's PBPCs. The purpose of putting the MDR1 gene into~     the patients' PBPCs is to try to make these blood cells and their offspring resistant to the~     toxic effects of certain types of breast cancer chemotherapy. The MDR1 protein (Pgp) that is~     made from the MDR1 gene makes cells resistant to chemotherapy in laboratory systems by~     pumping the drug out of cells before the drug is able to kill the cell. Another portion of~     the patients PBPCs will be exposed to a similar disabled virus carrying a different gene~     called the NeoR gene. The NeoR gene should not change the effects of chemotherapy on blood~     forming cells. The purpose of using the NeoR gene is that it will serve as a point of~     comparison, to see if the presence of the MDR1 drug resistance gene really helps blood~     forming cells withstand subsequent chemotherapy.~      Patients are then treated with a very high dose of another anti-breast cancer drug, one that~     is very toxic to bone marrow cells, and patients will then receive the frozen PBPCs, which~     contain the new genes, to help them recover from the chemotherapy. After recovery, patients~     will then be treated with high doses of paclitaxel (Taxol) and doxorubicin (Adriamycin)~     chemotherapy. Both of these drugs are very active against breast cancer, and the MDR1 gene~     may potentially protect bone marrow cells against these drugs. Samples of peripheral blood~     cells will be obtained before each of these doses of chemotherapy to determine whether the~     number of blood cells that contain the MDR1 gene in comparison to the number that contain the~     NeoR gene has increased in response to the chemotherapy.~   "
270374|NCT00001489|"~     This study is designed to test the effects of vigabatrin (gamma-vinyl-GABA) an experimental~     drug used for the treatment of epilepsy. The study will use positron emission tomography (PET~     scan) to detect areas of the brain receiving increased blood flow and using increased amounts~     of glucose. Increases in blood flow and glucose use are good indicators of brain activity.~      Researchers are interested in determining the effects of Vigabatrin on brain blood flow and~     glucose use.~   "
270375|NCT00001485|"~     As the seasons change during the course of the year, many animals show major changes in their~     behavior and physiology. Many of these changes are triggered by changes in the length of time~     each night that the pineal gland produces the hormone melatonin. Melatonin is produced for a~     longer time in winter when nights are long, than in summer when nights are short.~      Some researchers believe that melatonin may play a similar role in how season effects mood of~     patients with seasonal affective disorder. Seasonal affective disorder (SAD) or mood disorder~     with seasonal pattern is a condition where the normal biorhythm is disturbed during a season,~     especially autumn-winter. Patients may begin experiencing or experience worsening of~     depressive symptoms. Patients complain of being constantly tired, craving sugary foods,~     overeating, and over sleeping.~      Researchers have collected some preliminary data showing that the duration of nighttime~     melatonin secretion increases in winter and decreases in summer in healthy women, but not in~     healthy men. However, men diagnosed with SAD have shown longer duration of melatonin~     secretion in the winter, similar to the duration seen in healthy women. If these early~     findings are confirmed it may explain why SAD is more common in women than in men.~      The purpose of this study is to continue researching the differences in melatonin secretion~     over the seasons in healthy men and women, and to determine how these findings may apply to~     patients with SAD.~   "
270376|NCT00001482|"~     This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal)~     Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective~     disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that~     of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so~     that we examine possible clinical and biological factors predictors of response. The drugs~     will be given in a randomized order for six weeks each and you will not know when you are on~     a given one. There will be a 2-4 week washout period between treatments. If you respond~     well to one of these treatments, a longer open continuation period will be offered at the end~     of this study. This would involve one or both drugs in combination. A variety of rating~     scales and brain imaging procedures will also be offered before and during each drug~     evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious~     potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine,~     however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred~     vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually~     mild, and resolve with continued time on the drug or a decrease in dosage.~   "
270377|NCT00001479|"~     Major depression represents a major public health problem worldwide and in the U.S. Fifteen~     percent of the U.S. population has depression at some point in life (40 million individuals).~     The condition is more common in women, occurring at a female to male ratio of 5:2. Presently,~     6-8% of all outpatients in primary care meet the diagnostic criteria for major depression.~     Fifteen percent of untreated patients with depression will commit suicide. Most of the people~     committing suicide are depressed. Researchers believe that by the year 2020 suicide will be~     the 10th most common cause of death in the U.S.~      In addition to mortality due to suicide, depression is also associated with other severe~     health conditions. Areas of the brain (hippocampus) begin to deteriorate, heart disease, and~     decreased bone mineral density (osteoporosis) are all associated with major depression.~      Researchers have believed for years that hormones controlled by the hypothalmus, pituitary~     gland, and adrenal gland (commonly referred to as the HPA axis or system) are in some way~     associated with psychiatric illnesses like depression.~      According to previous studies, researchers have theorized that increased activity of the HPA~     axis is associated with depressed patients with typical melancholic features. Melancholia~     refers to the feelings of anhedonia (absence of pleasure from activites that would normally~     be thought of as pleasurable), insomnia (inability to sleep), guilt, and psychomotor changes.~     On the other hand a decrease in activity of the HPA axis may be associated with the atypical~     features of depression.~      This study has already developed and refined studies that have improved the understanding of~     the HPA axis in healthy humans and depressed patients. Researchers have already identified~     and plan to continue identifying distinct subtypes of depressive disorders based on the~     activity of the HPA axis.~   "
270378|NCT00001478|"~     Positron Emission Tomography (PET) is a technique used to investigate the functional activity~     of the brain. The PET technique allows doctors to study the normal biochemical and metabolic~     processes of the central nervous system of normal individuals and patients with neurologic~     illnesses without physical / structural damage to the brain.~      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar~     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and~     water. Blood carries fuel to the brain and waste products away from the brain. As brain~     activity increases blood flow to and from the area of activity increases also. Knowing these~     facts, researchers can use radioactive chemicals (H215O) and PET scans to observe what areas~     of the brain are receiving more blood flow.~      Patients diagnosed with mood disorders and healthy volunteers will receive positron emission~     tomographic (PET) scans with H215O while doing simple tasks. Patients will continue to~     receive scans while in different mood states and while taking different medications. Patients~     eligible for this study will be participating in other research studies measuring other~     clinical and biochemical parameters (mood and anxiety ratings, medication responses, and~     psychological test results). Information gathered from H215O PET scans measuring blood flow~     to specific brain areas will be compared to the data gathered from other studies.~      Objectives of this study are;~        1. To determine differences in blood flow to the brain of patients with mood disorders~          compared to healthy volunteers.~        2. To determine differences in blood flow to the brain of patients with subtype mood~          disorders (such as unipolar versus bipolar) compared to healthy volunteers.~      2. To determine changes in blood flow to the brain of patients with mood disorders who~     experience spontaneous changes in symptoms~      3. To determine changes in blood flow to the brain of patients with mood disorders who~     receive various kinds of therapy (medication, transcranial magnetic stimulation, etc.)~      4. To determine if blood flow to specific areas of the brain can be used to predict how~     patients will respond to certain types of therapy~      5. To compare blood flow changes with various other clinical and biochemical parameters.~   "
270379|NCT00001477|"~     Patients are exposed to infectious agents regularly, regardless of their immunologic status.~     Traditionally clinicians have decided to institute prophylaxis based on epidemiologic~     factors, skin test (i.e. PPD), or immunologic parameters. A quantitative and specific method~     that is non-invasive, such as quantitative PCR, would be desirable to more precisely define~     those who would benefit from prophylaxis. Similarly, when patients develop disease and are~     being treated, quantitative, non-invasive techniques are needed to assess response to~     therapy. This project is designed to develop and test quantitative tests using blood, urine,~     or sputum samples.~   "
270380|NCT00001468|"~     This study will identify how personal beliefs, values and family experiences affect a~     person's decision as to whether or not to be tested for changes in a gene called BRCA1 or~     BRCA2. Changes in these genes are associated with a significantly increased risk of breast~     and ovarian cancer in women, a slightly higher risk of prostate cancer in men, and a slightly~     higher risk of colon cancer in both men and women.~      Families enrolled in the National Cancer Institute's familial cancer research project who~     also participated in a telephone survey (protocol 78-C-0039) regarding their level of~     interest in BRCA1/2 testing results may be eligible for this study.~      All participants will complete a 20- to 30-minute questionnaire assessing knowledge, risk~     perception and personality traits, and will participate in an education session to review the~     following:~        -  Information about their individual cancer risk, based on family history~        -  Potential benefits and risks (medical, psychological and social) of BRCA1/2 testing,~          both for those who test positive and those who test negative~        -  Overview of DNA testing (what is done and how accurate it may or may not be)~        -  Medical management options for those at increased risk for breast and ovarian cancer~        -  Environmental cancer risk factors~        -  Instruction in breast self-examination~      Participants will then be asked whether or not they want to undergo BRCA1/2 testing~      Those who want to be tested will be divided into two groups to compare counseling methods~     (client-centered vs. counselor-driven counseling). A small blood sample (2 to 3 tablespoons)~     will be drawn for genetic analysis. Test results will be provided in person at a second~     visit-this may take 6 months or more. A follow-up telephone call 2 weeks after receipt of the~     test results will address participants' questions and provide support. During a third visit,~     scheduled 6 months after receipt of the test results, participants will complete~     questionnaires evaluating mood, attitude, self-esteem, family interactions, cancer screening~     practices, and other factors. Finally, 1 year after receipt of the test results, participants~     will be contacted by telephone and asked about their feelings about the test and its outcome.~      Individuals who choose not to have gene testing will not participate in any in-person~     sessions after the initial visit. They will be followed with no more than two telephone~     interviews to assess their feelings and attitudes related to their decision not to be tested.~      Individuals may reconsider and change their mind at any time regarding their decision-whether~     to be tested or not.~      The results of the study will help experts devise the most effective methods of educating and~     counseling people at high risk for having an altered BRCA1/2 gene.~   "
270381|NCT00001466|"~     This study will investigate the cause and natural history (medical problems that appear over~     time) of certain genetic disorders. It will also try to locate the abnormal genes responsible~     for these conditions and eventually develop tests to predict who is likely to be affected and~     to what degree.~      Patients with known or suspected genetic disorders in certain categories, such as those~     involving chromosomal or metabolic abnormalities, immune system or blood disorders, abnormal~     growth, benign tumors, and others may be eligible for this study. Participants will be~     interviewed by specialists in genetics about their condition and family history. They may~     also be asked to have a physical examination and certain tests needed for study of the~     specific individual's condition. These may include collection of blood samples (up to 3~     tablespoons); imaging studies, such as computerized tomography (CT), magnetic resonance~     imaging (MRI), ultrasound and echocardiography; skin biopsy (removal of a small sample of~     skin tissue under local anesthetic), and other procedures. DNA testing may reveal the genetic~     abnormality responsible for the disorder. Participants who so wish will have an opportunity~     to talk with experts about the health implications of the test results.~      This study may provide information that will lead to improved treatment or management of~     these inherited disorders, as well as more effective genetic counseling for families.~   "
270382|NCT00001462|"~     Alpha 1-antitrypsin-deficient individuals develop severe destructive lung disease much~     earlier and their lung function declines faster than the general population of individuals~     with chronic obstructive lung disease. This study is designed to better understand the~     pathogenesis of lung destruction in alpha 1-antitrypsin deficient individuals and to~     characterize the pathobiology of early lung destruction. To accomplish this we intend to use~     bronchoalveolar lavage to determine and quantify the factors that initiate and sustain lung~     inflammation in alpha 1-antitrypsin deficient individuals with lung function above a force~     expiratory volume in one second (FEV1) of greater than 50% of predicted.~   "
270397|NCT00001431|"~     Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation~     using 4-15 MV photons; plus Gemcitabine, NSC-613327.~   "
270383|NCT00001461|"~     The walls of blood vessels are lined by flat cells that are responsible for releasing~     substance(s) that control the activity of the blood vessel. These cells are referred to as~     the endothelium of the blood vessel. One of the substances released from the endothelium is~     called nitric oxide (NO). This substance functions to keep blood vessels relaxed and to~     prevent blood from clotting inside the vessels.~      Studies done by researchers in the Cardiology Branch of the National Heart, Lung and Blood~     Institute have shown that nitric oxide activity may be lower in patients with hardening of~     the arteries (atherosclerosis) and risk factors for atherosclerosis.~      Another substance released by the cells of the endothelium is called bradykinin. It functions~     to stimulate the production of nitric oxide. Therefore bradykinin is also responsible for the~     relaxation and widening of blood vessels.~      An enzyme found in the blood called angiotensin-converting enzyme (ACE) inactivates~     baradykinin and thereby decreases the production of nitric oxide. The activity of ACE is~     determined by genetics and is different in each person. Medications that block ACE~     (ACE-inhibitors) may be useful for patients with high levels of ACE activity.~      This study is designed to determine;~        1. The role of bradkinin in stimulating the production of nitric oxide~        2. Whether ACE-inhibitors improve blood vessel relaxation caused by bradykinin~        3. Whether ACE-inhibitors improve abnormal blood vessel relaxation~        4. Whether ACE-inhibitors and bradykinin affect blood clotting~        5. Whether blood vessel response to ACE-inhibitor and bradykinin depends on the patients~          genetic make-up~   "
270384|NCT00001459|"~     Myocardial ischemia is a heart condition in which not enough blood supply and oxygen reaches~     the heart muscle. Damage to the major blood vessels of the heart (coronary artery disease),~     minor blood vessels of the heart (microvascular heart disease), or damage to the heart muscle~     (hypertrophic cardiomyopathy) can cause myocardial ischemia. Any of theses three conditions~     can cause patients to experience chest pain and other symptoms as well as cause the heart to~     function improperly.~      In order to detect myocardial ischemia researchers can use tests to measure the movement of~     the walls of the heart. Walls receiving inadequate supplies of blood often move less and~     occasionally move in the opposite direction. Some of the tests may require patients to~     receive injections of radioactive tracers. The radioactive material acts to enhance 3~     dimensional pictures of the heart and helps to identify areas of ischemia.~      The purpose of this study is to determine whether 3-dimensional imaging (tomography) with~     radioactive tracers can provide more important information about heart wall function than~     routine diagnostic tests.~   "
270385|NCT00001455|"~     Iron overload (hemochromatosis) is a condition which causes the intestines to take too much~     iron into the body from food or pills. The extra iron can build up in the liver, heart,~     joints, pancreas, sex organs, and other organs. Patients with iron overload can feel well~     initially, but the iron will eventually damage organs and may lead to an early death. The~     condition is believed to be passed down from generation to generation. Many studies have been~     conducted on the condition as it affects Caucasian Americans, few have addressed the~     condition in African Americans.~      Researchers believe it is important to find out as much as possible about the iron overload~     in African Americans. The goal of this study is to determine the pattern of inheritance of~     primary iron overload in African American families and to identify the genetic defect causing~     the condition.~      The study will use various tests from simple blood testing (transferritin saturation and~     serum ferritin levels) to complex genetic tests (segregation analysis and polymerase chain~     reaction [PCR]). The tests will help researchers deterimine iron levels in the blood,~     presence of antigens that may help trace inheritance, and detect changes in genes that are~     known to cause iron overload in Caucasians.~      The study may not directly benefit the patients participating in it. However, this study may~     lead to improved methods to diagnose iron overload in the African American population as a~     whole.~   "
270386|NCT00001450|"~     This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous~     infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV~     or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to~     determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in~     patients with advanced NSCLC.~   "
270387|NCT00001449|"~     The purpose of this study is to determine the clinical toxicities associated with~     administering sequential dFdC as a one hour infusion followed by a continuous infusion of~     FUdR over 24 hours with low dose oral LV weekly for three weeks out of four.~   "
270388|NCT00001448|"~     The main objectives of this study are: 1) to determine whether various levels of severity of~     oral candidiasis (thrush) in the child are associated with different levels of speech~     production, feeding skills, and self-concept, and 2) to assess the effect of the reduction of~     oral thrush over time on the speech function, feeding skills, and self-concept in~     HIV-infected patients who already are receiving various antifungal medications for treatment~     of their thrush (Note: Decisions regarding antifungal therapy are made completely independent~     from this study).~      Children with HIV disease, ages 6-21 years, who have oral thrush are eligible to paricipate~     in the study. The child and his/her parent will be asked to complete a variety of measures at~     specific time intervals over approximately one month during visits to the National Institutes~     of Health for treatment on other protocols. First, a nurse will rate the location and~     severity of thrush in the child's mouth. Then the parent will complete questionnaires~     assessing the effect of oral thrush on the child's feeding and speech skills and everyday~     functioning. Finally, the child will be administered a brief speech and oral-motor evaluation~     and will complete some questionnaires about how the thrush affects his/her day-to-day~     activities and self-concept.~      The results of this study may help to better understand the cause of expressive language~     deficits observed in some children with HIV infection. More specifically, it will determine~     if any speech and feeding problems of HIV-infected children are associated with oral thrush.~     Learning more about the impact of oral thrush on the speech, feeding, and the self-concept of~     children with HIV disease may be used for parent and patient education and to develop~     rehabilitative recommendations to benefit HIV-infected patients with oral thrush.~   "
270389|NCT00001446|"~     This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide~     in patients with hormone-refractory prostate cancer.~      An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as~     well as make correlations between the degree of angiogenesis occurring in a patient and the~     activity of thalidomide.~   "
270390|NCT00001445|"~     This is a single dose, phase I study to evaluate the safety/tolerance and the immunogenicity~     of HIV-1 Immunogen, gp120-depleted inactivated HIV-1 preparation in Incomplete Freund's~     Adjuvant (IFA), in children with HIV-1 infection. A total of 32 children with HIV-1 infection~     will be enrolled in the study. Arm A of the study will enroll children who have no or~     moderate immune suppression at the time of study entry as defined by CDC classification and~     who have no history of and do not require antiretroviral therapy. Antiretroviral treatment~     given for less than 7 weeks (up to 6 weeks and 6 days) prior to entry will be considered as~     no history of treatment (treatment naive). Arm B will enroll children who have no or~     moderate immune suppression at the time of study entry as defined by CDC classification and~     who are on or have received antiretroviral treatment for more than 7 weeks. In order to~     assess the age-associated impact on the immune response rate, we plan to continue to attempt~     to enroll infants younger than 24 months of age. Children in each arm will receive 10 units~     of HIV-1 Immunogen intramuscularly at 0, 3, 6, 9, and 12 months.~      Antiretroviral treatment will commence once patients meet the criteria for an initiation of~     the treatment as defined in the protocol. All antiretroviral agents that are currently~     approved by FDA for clinical indications in HIV-1-infected children (pediatric labeling) are~     permitted in the protocol. If the child has been receiving a single agent other than ddI, or~     has been on investigational antiretroviral agents, his/her antiretroviral therapy will have~     to be changed to an optimal combination regimen of the approved agents at least 6 weeks prior~     to the enrollment.~   "
270391|NCT00001443|"~     This is a phase I/II study to determine the safety and tolerance of the protease inhibitor~     indinavir (MK-0639), alone and then in combination with HIV reverse transcriptase inhibitor~     therapy in children with HIV infection. Indinavir sulfate (the capsule formulation) has been~     shown to have potent antiviral activity and an acceptable safety profile in adults.~     HIV-infected children who have not received prior antiretroviral therapy, and children who~     have become refractory to prior therapy, or who have experienced toxicity to prior therapy,~     will be included. In addition, we will explore viral and CD4 cell kinetics before starting~     therapy and following exposure to antiretroviral agents.~      The study will be conducted in three parts.~        1. In order to help interpret the antiviral activity of indinavir, the virologic and~          immunologic profile of children will be studied within 2 weeks prior to starting the~          therapeutic part. For children who have never been treated, this will be before the~          initiation of any antiretroviral therapy and for children who have already received~          antiretroviral therapy, this will be done during the initial wash-out phase that is~          routinely interposed between two different treatment regimens.~        2. The initial 16 weeks of therapy will then evaluate the toxicities, pharmacokinetics, and~          preliminary efficacy of single drug therapy with indinavir.~        3. Subsequently, all children who are able to tolerate the combination of zidovudine and~          lamivudine (i.e., have no prior history of intolerance to one of these two agents) will~          be treated with these two reverse transcriptase inhibitors in addition to the protease~          inhibitor indinavir. Zidovudine and lamivudine will be added after 16 weeks at a fixed~          dosage. Toxicity, pharmacokinetics, and preliminary efficacy of indinavir will also be~          investigated after combination therapy. All patients who wish to remain in this study~          after 96 weeks of therapy and who do not meet off study criteria will be permitted to~          receive extended treatment with their current indinavir combination therapy for an~          additional 48 weeks.~      The study will determine the pharmacokinetic profile of indinavir, given as single drug or in~     combination with zidovudine and lamivudine. It will assess the preliminary antiviral and~     clinical activity by monitoring clinical status, viral burden in plasma, and markers of~     immunologic status. Based on safety and preliminary efficacy results from studies performed~     in adults, we will study three dose levels which are expected to result in drug levels above~     the IC95 of HIV-1 for all or most of the dosing interval.~   "
270392|NCT00001439|"~     This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid~     peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be~     administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is~     designed to evaluate the toxicity, immunologic effects and potential therapeutic role of~     repeated doses of gp100 peptide vaccines administered subcutaneously.~      Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis~     of melanoma-specific T cell precursor frequency prior to and after immunization.~   "
270393|NCT00001438|"~     Patients with congenital or acquired immunodeficiencies are at an increased risk to develop~     polyclonal or oligoclonal lymphoid malignancies. Some develop a lymphoproliferative disorder~     that can follow a clinically aggressive course and may represent a pre-malignant lesion.~     Although most of these lymphoproliferative disorders are of B-cell origin, T-cell or~     non-B-non-T-cell processes have also been observed. The pathogenesis is only partially~     understood.~      In the case of pre-malignant conditions it is often difficult to know when and whether a~     therapeutic intervention is necessary and a careful consideration of potential~     treatment-associated morbidity is indicated. Therapies have ranged from influencing the~     possible infectious etiology (by treating with acyclovir), decreasing the amount of~     immunosuppression (in transplant patients), to the use of immunomodulatory agents, including~     interferons and interleukins. Recent data have indicated that the use of differentiating~     agents, such as the retinoids, might offer yet another treatment option. In the current study~     we will try to get a better understanding of the pathogenesis and natural course of~     lymphoproliferative disorders in immunodeficient children.~      The study will have two parts: an initial observation period to obtain information on the~     natural course of these disorders, and then a six month treatment period with the combination~     of a differentiating agent (13-cis-retinoic acid was used until all-trans-retinoic acid~     became available on 7/96) with an immunomodulatory agent (interferon-alpha2a, IFN-alpha2a).~   "
270394|NCT00001437|"~     After initial assessment of their condition by specified clinical and laboratory parameters,~     each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg~     po TID). Objective and subjective response parameters will be re-assessed at the end of the~     treatment and 8 weeks later for possible decay of response.~   "
270395|NCT00001436|"~     The suppression of IGF-I and growth hormone may significantly alter the pathobiology of~     osteosarcoma. SMS 201-955 pa LAR is a long acting analog of Somatostatin which inhibits the~     pituitary release of growth hormone, reducing levels of circulating IGF-I . Additional data~     on tamoxifen usage has also demonstrated a reduction in circulating IGF-I levels. The degree~     of suppression of IGF-I and growth hormone will be determined at two dose levels of SMS~     291-955 pa LAR. Tamoxifen will be added to two of the cohorts to determine if the additive~     effects of tamoxifen and SMS 201-955 pa LAR will lead to additional reduction of circulating~     IGF-I and growth hormone levels.~      Arginine-stimulated GH tests to assess levels of growth hormone in the blood will be~     administered pre-treatment evaluation up to three times, one time on weeks 2, 8, 16, 28, 40,~     52, and one month post last dose of SMS 201-955 pa LAR.~      The four cohorts for this study will receive 60 or 90 mg SMS 201-955 pa LAR injectable every~     four weeks for up to 52 weeks. Two of the cohorts will receive 10 mg Tamoxifen on a daily~     basis.~   "
270398|NCT00001428|"~     This protocol will evaluate the activity of 5-Fluorouracil (FUra) given as a 1 hour infusion~     in combination with leucovorin (LV) and interferon IFN alpha-2a in patients with advanced,~     measurable colorectal cancer.~   "
270675|NCT00046267|"~     The purpose of this study is to evaluate the safety, efficacy, and tolerability of~     extended-release niacin (Niaspan) in improving the level of fats in the blood of HIV-infected~     patients.~   "
270402|NCT00001421|"~     This study will test the safety and effectiveness of the drug methimazole in treating~     polymyositis and dermatomyositis-inflammatory muscle diseases causing weakness and muscle~     wasting. Although it is not known what causes of these diseases, abnormal immune function is~     thought to be involved. Recent studies indicate that methimazole, which has been used for~     many years to treat thyroid disease, may alter immune activity by affecting the interaction~     between white blood cells called lymphocytes and certain molecules on cell surfaces. This~     study will examine the effects of methimazole on immune activity and muscle strength in~     patients with inflammatory muscle diseases and evaluate the drug side effects.~      Patients with polymyositis and dermatomyositis who have normal thyroid function may be~     eligible for this study [age requirement?]. Candidates will undergo a history and physical~     examination; blood and urine tests; chest X-ray; muscle strength testing, daily living skills~     questionnaire, and speech and swallowing evaluation; magnetic resonance imaging of muscles;~     and muscle biopsy (removal of a small piece of muscle tissue under local anesthetic). When~     indicated, some candidates may also have cancer screening tests (for example, mammogram, Pap~     smear), a lung function test to measure breathing capacity, or an electromyogram, in which~     small needles are inserted into a muscle to measure the electrical activity .~      Participants will take 30 mg of methimazole by mouth twice a day for 6 months. They will have~     blood tests weekly for the first 2 weeks and then every other week for the rest of the study~     to measure blood counts and liver and thyroid function. Blood will also be drawn for white~     blood cell studies during the screening evaluation, at the beginning of therapy, 6 to 12~     weeks after therapy starts, at the end of the 6-month treatment period, and 1 and 3 months~     after therapy ends. Muscle enzyme and urine tests will be done once a month.. During drug~     treatment, patients will have periodic physical examinations and blood and muscle function~     tests to evaluate the response to therapy.~   "
270403|NCT00001416|"~     The purpose of this study is to examine how the skeleton responds to repeated doses of enzyme~     replacement therapy in patients with type I Gaucher's disease who have had their spleens~     removed.~      Gaucher disease is a lysosomal storage disease resulting from glycocerebroside accumulation~     in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in~     adults but occurs most severely in infants, in whom cerebroside also accumulates in neurons.~     Patients with Gaucher's disease experience enlargement of the liver and spleen and bone~     destruction. The condition is passed from generation to generation through autosomal~     recessive inheritance.~      Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease~     does not affect nerve cells. The symptoms of type I can appear at any age.~      In this study patients will be divided into three groups. Each group will receive different~     doses of enzyme replacement (Ceredase). In addition, two of the three groups will also~     receive doses of a form of vitamin D (calcitriol). Researchers believe the groups receiving~     vitamin D will have an improved response as compared to those patients only receiving enzyme~     replacement.~      Patients in each group who respond to enzyme replacement with increases in bone density will~     be compared to the other treatment groups.~   "
270404|NCT00001415|"~     A variety of hormones and immune system processes are responsible for how the body responds~     to illness. This study concentrates on how the hormone cortisol effects the release of immune~     system factors called cytokines.~      Cortisol is a hormone produced in the adrenal glands as a response to stimulation from the~     pituitary gland. Abnormal levels of cortisol have been seen in several diseases such as~     depression and multiple sclerosis.~      Cytokines are factors produced by certain white blood cells. They act by changing the cells~     that produce them (autocrine effect), altering other cells close to them (paracrine), and~     effecting cells throughout the body (endocrine effect). Cytokines are important in~     controlling inflammation processes.~      In this study researchers would like to determine if changes in levels of hormones in the~     blood are associated with changes in cytokine levels. In addition, researchers would like to~     learn more about how cytokines respond to hormones in certain diseases.~   "
270405|NCT00001402|"~     The human heart is divided into four chambers. One of the four chambers, the left ventricle,~     is the chamber mainly responsible for pumping blood out of the heart into the circulation.~     Diseases of the heart like congestive heart failure (CHF), can cause the left ventricle to~     function improperly.~      Medications called beta-blockers appear to reverse the abnormalities in the left ventricle~     and frequently improve the function of the left ventricle in patients with different kinds of~     heart disease. How beta-blockers improve left ventricle function is unknown.~      One possible reason for improved function of the left ventricle with beta-blockers is~     improved blood flow to the heart muscle. When a region of the heart is active, it uses more~     fuel in the form of oxygen and sugar (glucose). As heart activity increases, blood flow to~     and from the area of activity increases also. Knowing these facts, researchers can use~     radioactive sugar (glucose) and positron emission tomography (PET) scans to observe what~     areas of the heart are receiving more blood flow.~      In this study researchers plan to measure glucose use in heart muscle and blood flow to the~     heart muscle in patients with CHF taking beta-blockers.~   "
270406|NCT00001395|"~     The efficacy of laser photocoagulation treatment for diabetic retinopathy has been~     demonstrated by several National Eye Institute (NEI) sponsored clinical trials. The Diabetic~     Retinopathy Study (DRS) demonstrated that scatter photocoagulation reduces the risk of~     blindness from diabetic retinopathy. The Early Treatment Diabetic Retinopathy Study (ETDRS)~     extended these findings by providing information on when to initiate scatter photocoagulation~     and by demonstrating that focal treatment was effective in treating macula edema. The Krypton~     Argon Regression Neovascularization Study (KARNS) showed that scatter photocoagulation with~     krypton red laser was just as safe and effective as the argon blue-green laser in the~     treatment of proliferative diabetic retinopathy.~      Unfortunately, there is little data on the long term effects of photocoagulation on visual~     function. The first objective of this study is to assess the long term effects of~     photocoagulation for diabetic retinopathy. A second objective is to provide additional~     information on the risk of progression of cataracts in persons with diabetes. All patients~     previously treated with laser photocoagulation (focal and/or scatter) are eligible to~     participate in this long term study. The first priority will be given to patients who~     participated in the ETDRS and KARNS because of the wealth of information available regarding~     the details of their treatment and course after treatment. Study evaluations will include a~     standard ophthalmic examination, fluorescein angiography, lens and fundus photography.~   "
270407|NCT00001387|"~     The objective of this trial is to determine the maximum tolerated dose and the toxicities of~     paclitaxel given as a short hour infusion in children with refractory malignancy.~   "
270538|NCT00048737|"~     The goal of this clinical research study is to see if low intensity chemotherapy given~     together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem~     cells from a donor can increase the length of remission in patients with leukemia and~     lymphoma. The safety of this treatment will also be studied.~   "
270698|NCT00045916|"~     This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered~     with medication for the treatment of a major depressive episode (unipolar or bipolar) and~     will compare two types of ECT.~   "
270408|NCT00001385|"~     This is a prospective study evaluating the role of Positron Emission Tomography (PET scan) in~     breast cancer. The radiopharmaceutical [18F] 2-deoxyglucose will be used as both an imaging~     modality and to evaluate tumor metabolism in patients with breast cancer. Patients with stage~     II, stage IIIA or IIIB, or stage IV breast cancer and evaluable disease in the breast and/or~     at metastatic sites will be studied. Patients will be injected intravenously with~     [18F]2-deoxyglucose and a PET scan conducted over 90 minutes. Examination of the role of PET~     scan in assessing the response of breast cancer to chemotherapy, especially in stage II and~     stage III patients, will be done. Up to three PET scans within one year may be performed.~     Findings by PET scan will be correlated both with those of concurrent imaging techniques~     (x-ray, CT scan, MRI, bone scan or mammogram), and with histologic, biochemical, and flow~     cytometric information on the tumor, and with findings in subsequent surgical specimens.~     Changes in tumor glucose metabolism with treatment will be assessed by PET imaging studies~     and by biochemical methods when possible.~   "
270409|NCT00001384|"~     This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with~     G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for~     patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in~     duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3~     fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to~     assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed~     by infusional paclitaxel in 14 day cycles.~   "
270410|NCT00001383|"~     This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance~     inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive~     continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel~     on the first course, then beginning 3 days prior to paclitaxel on subsequent courses.~      Stable and responding patients are re-treated every 21 days, with paclitaxel dose adjusted to~     maintain an absolute neutrophil count less than 500 for no more than 4 days.~   "
270411|NCT00001382|"~     This trial will evaluate, in patients with metastatic prostate cancer, the tolerability,~     toxicities, efficacy, and immunologic effects of repeated vaccinations with a recombinant~     vaccinia virus that contains the Prostate Specific Antigen gene (PROSTVAC).~   "
270412|NCT00001381|"~     Patients with superficial transitional cell carcinoma of the bladder will be treated with~     intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered~     in this fashion will be evaluated.~   "
270413|NCT00001378|"~     This is a pilot, chemoprevention study. Patients receive fenretinide daily for 25 of every 28~     days for 4 months and tamoxifen daily for 23 months, beginning the second month of~     fenretinide.~      Patients are removed from study for unacceptable toxicity, the development of invasive breast~     cancer, or for dysfunctional uterine bleeding.~   "
270414|NCT00001377|"~     The purpose of this study is to identify affected individuals in families with prostate~     cancer and to use this information to identify genetic markers closely-linked to the disease~     gene.~   "
270415|NCT00001376|"~     This study is designed to evaluate blood Th1 and Th2 immunoregulatory cytokine production and~     hormonal levels associated with the third trimester of pregnancy and the postpartum state.~     Cytokine and hormone levels will be assessed in blood specimens obtained from healthy~     pregnant and postpartum females and compared to levels from premenopausal non-pregnant and~     non-postpartum females. Blood samples obtained at 30-36 weeks of gestation and 2-6 weeks~     postpartum will be the primary study points. Samples will also be obtained from pregnant,~     postpartum, and non-pregnant, non-postpartum, premenopausal female patients with rheumatoid~     arthritis. Additional data will be generated from samples from normal males, which will be~     compared with data from females.~      We expect to find that pregnancy is associated with enhanced Th2 cytokine expression and that~     the postpartum state is associated with enhanced Th1 cytokine expression. We expect to see~     differences in cytokine expression between males and females as well. We seek to gather data~     supporting the view that distinct hormonal environments regulate these contrasting~     immunological states.~   "
270416|NCT00001375|"~     This study will evaluate patients with inflammatory forms of arthritis within the first year~     of onset. The study will attempt to clarify factors that may predict disease course such as~     evolution into rheumatoid arthritis (RA) or other chronic inflammatory arthropathies.~     Synovial biopsies and synovial fluid will be obtained to search for microbial agents and~     other initiating and modulating factors that may be most readily distinguished early in the~     disease and to determine the stage of disease at which certain immunologic and hormonal~     changes become evident. The study will also search for genetic and other features that may be~     associated with specific forms of inflammatory arthropathies that might predict the~     subsequent clinical disease course or response to different agents used in treatment of RA,~     Reiter's syndrome and other types of chronic inflammatory arthropathies.~   "
270417|NCT00001371|"~     This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2~     (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment~     base, or the vehicle alone will each be applied four times per day to a single plaque in a~     randomized, double-blinded fashion.~   "
270418|NCT00001365|"~     This study is designed to determine whether dextromethorphan, a drug commonly found in cough~     medicine, is beneficial and safe for the treatment of Parkinson's disease and other diseases~     that might share biochemical abnormalities with Parkinson's disease.~      Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This~     occurs as a result of destructive changes in an area of the brain responsible for making~     dopamine, the basal ganglia. Rhythmical muscular tremors, rigidity of movement, shuffling~     footsteps, droopy posture, and a mask-like expression on the face characterize Parkinson's~     disease.~      Researchers believe that dextromethorphan may be able to safely modify psychomotor function~     of patients with Parkinson's Disease.~   "
270539|NCT00048724|"~     The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no~     treatment for the prevention of disease progression in adult subjects with compensated~     cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a~     interferon plus ribavirin.~   "
270540|NCT00048711|"~     The purpose of the study is evaluate the efficacy, safety, and pharmacokinetics of weekly~     intravenous infusions of 1 mg/kg recombinant human N-acetylgalactosamine 4-sulfatase (rhASB)~     in patients diagnosed with Mucopolysaccharidosis VI (MPS VI)~   "
270419|NCT00001363|"~     Positron Emission Tomography (PET) is a technique used to investigate the functional activity~     of the brain. The PET technique allows doctors to study the normal processes of the brain~     (central nervous system) of normal individuals and patients with neurologic illnesses without~     physical / structural damage to the brain.~      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar~     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and~     water. Blood carries fuel to the brain and waste products away from the brain. As brain~     activity increases blood flow to and from the area of activity increases also. Knowing these~     facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of~     the brain are receiving more blood flow.~      This study will attempt to determine the areas of the brain activated by planning processes~     and decision making. Researchers will ask patients to participate in tests and games (chess)~     that will stimulate the areas of the brain involved with decision making and planning while~     undergoing the water PET blood flow technique.~   "
270420|NCT00001346|"~     The purpose of this study is to evaluate possible mechanisms of central visual loss in~     patients with diabetes mellitus. The visual loss of interest to be investigated is that~     associated with macular edema (prior to and following laser photocoagulation treatment) and~     that associated with panretinal photocoagulation. The evaluation will be performed with~     psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of~     particular interest, the mechanisms of visual loss associated with macular edema (prior to~     and following laser photocoagulation) will be further investigated. Photoreceptor-mediated~     visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss~     mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer~     spatial desensitization/sensitization effect.~   "
270421|NCT00001344|"~     In our current clinical trial, we are comparing the effects of two NMDA receptor antagonists~     to placebo in patients with painful distal symmetrical diabetic neuropathy or post-herpetic~     neuralgia. The treatments in this three-period crossover study are dextromethorphan, up to~     920 mg/day (about 8 times the antitussive dose), memantine, 30-50 mg/day, and placebo.~     Memantine is an NMDA antagonist used in Europe to treat Parkinson's disease and Alzheimer's~     disease. The underlying hypothesis, based on studies of painful neuropathies in animal~     models, is that neuropathic pain is caused largely by sensitization of central nervous system~     neurons caused by excitatory amino acid neurotransmitters, acting largely through NMDA~     receptors. A previous small trial of dextromethorphan suggested efficacy in diabetic~     neuropathy pain. The study requires one visit to the NIH outpatient Pain Research Clinic, and~     consists of three 9-week treatment periods. Patients who respond to one of the medications~     will be invited to participate in further controlled studies of the medication followed by up~     to several years of open-label treatment under continued observation.~   "
270422|NCT00001342|"~     Glycogen, is the storage form of glucose. It is usually formed from sugar and stored in the~     liver. When tissues, such as muscle, need glucose for fuel the stored glycogen is converted~     into glucose with the help of enzymes produced in the body. Glycogen storage disease (GSD)~     refers to a group of conditions characterized by abnormal storage of glycogen due to the~     absence of particular enzymes needed in the process of storing and using glycogen.~      This study addresses the related metabolic abnormalities of glycogen storage disease (GSD).~     As patients with disorders of glycogen metabolism are followed it becomes apparent that the~     condition is much more complex than initially thought.~      Researchers believe that patients suffering from glycogen storage disorders should be~     followed and monitored for other heritable metabolic disorders.~      This study will attempt to determine the frequency of associated disorders in patients with~     GSD. In addition, the study will look at the current management of these patients to see if~     the prognosis and course of the disease is changed.~   "
270423|NCT00001341|"~     Thymidylate synthase (TS), an enzyme which acts by utilizing 5,10-CH(2)FH(4) in the reductive~     methylation of deoxyuridylate (dUMP), is required for the de novo synthesis of thymidylate~     and is a potential chemotherapeutic target. ZD1694 is a new quinazolone folate analog that~     directly inhibits TS. This phase I trial and pharmacokinetic study will describe and define~     the toxicities, determine the MTD, and describe the plasma pharmacokinetics of ZD1694 in~     pediatric patients with refractory cancer. The starting dose for this trial will be 2.0~     mg/m(2) administered as a 15 minute IV infusion every 21 days.~   "
270424|NCT00001338|"~     This is a prospective, randomized Phase III trial of FLAC chemotherapy with GM-CSF versus~     PIXY321 in advanced breast cancer. The primary endpoints of this study will be the duration~     of thrombocytopenia and the time to recovery of platelets to 50,000/microliters. Other~     clinical endpoints will include the depth and duration of leukopenia, neutropenia, and~     anemia, the platelet and RBC transfusion requirements, and the number of documented instances~     of sepsis and hospitalizations for fever and neutropenia.~      Laboratory correlates will include the detailed evaluation of the effects on circulating~     hematopoietic progenitor cells by GM-CSF and PIXY321 and the potential effects these agents~     have on the bone marrow micro-environment.~      After 5 cycles of FLAC with GM-CSF versus PIXY321, patients will be treated with 5 cycles of~     96 hour infusional taxol. The goal of this part of the study will be to assess the toxicity~     and feasibility of administering infusional taxol following dose-intensive FLAC chemotherapy.~   "
270425|NCT00001333|"~     The purpose of this study is to determine the qualitative and quantitative toxicity of~     intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies~     refractory to conventional therapy (radiation therapy and chemotherapy).~   "
270426|NCT00001332|"~     Patients with gastric adenocarcinoma are most frequently diagnosed at an advanced stage. The~     disease has a marked propensity for loco-regional spread and will be the sole or major site~     of disease in up to 80% of patients. Various attempts at controlling loco-regional disease~     have not been successful. The selective lethal effect of supranormal temperatures on~     neoplastic cells and the additive or synergistic effect of combining chemotherapy has been~     well established in laboratory models and has provided the rationale for numerous clinical~     trials using hyperthermic isolated limb perfusion for advanced extremity melanoma or sarcoma.~     This Phase I study will evaluate the safety of escalating temperatures of continuous~     hyperthermic peritoneal perfusion (CHPP) with escalating doses of intraperitoneal Cisplatin~     (CDDP) in the treatment of patients with advanced peritoneal adenocarcinoma of~     gastrointestinal origin.~   "
270427|NCT00001330|"~     This study will examine the possible relationship between silicone implants or injections and~     the connective tissue diseases scleroderma and myositis. It will explore whether certain~     factors in the blood or the immune system or other factors are involved in the development of~     these diseases following silicone implantation or injection.~      Men and women 18 years of age and older who meet the following criteria may be eligible for~     this study:~      Group 1-Patients who have had silicone implants or injections and who later developed~     scleroderma or myositis~      Group 2-Patients with scleroderma or myositis who have not had silicone implants or~     injections~      Group 3-Healthy volunteers who have had silicone implants or injections and did not develop~     symptoms or other medical features of connective tissue disorders.~      Participants will have a thorough history and physical examination, blood and urine tests,~     chest X-ray and lung function tests. In addition, patients will complete a questionnaire~     about their procedure (including information such as the types of implanted devices and~     injections, reason for the procedure, post-operative complications, other illnesses or~     medical conditions present before and after the procedure, etc.).~   "
270428|NCT00001324|"~     Positron Emission Tomography (PET) is a technique used to investigate activity in areas of~     the brain. The PET technique allows researchers to study the normal processes in the brain~     (central nervous system) of normal individuals and patients with neurologic illnesses without~     physical / structural damage to the brain.~      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar~     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and~     water. Blood carries fuel to the brain and waste products away from the brain. As brain~     activity increases, blood flow to and from the area of activity also increases. This is known~     as regional cerebral blood flow (rCBF). Knowing these facts, researchers can use radioactive~     water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow.~      In this study researchers plan to investigate the changes in regional cerebral blood flow~     (rCBF) as patients participate in different activities. The activities are designed to~     stimulate the areas of the brain responsible for voluntary motor activity and sensation. By~     comparing the results of PET scans performed in different conditions, researchers can locate~     regions of the brain responsible for specific tasks.~      This study should provide new information about voluntary movements in humans and the~     preparation involved in controlling them.~   "
270429|NCT00001318|"~     This is an open label study to determine the effects of the administration of~     Interferon-gamma on the clinical condition and immune function of patients with severe,~     treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon~     gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year.~     We may also collect blood from the relatives of these patients and normal volunteers in order~     to characterize the genetic basis, if any, of our patients' disorders.~   "
270430|NCT00001317|"~     In a recent double-blinded, placebo-controlled multi-center international study, subcutaneous~     injections of interferon-gamma administered three times weekly reduced the frequency of~     serious infections in patients with chronic granulomatous disease. Patients receiving~     interferon-gamma had fewer hospital stays, shorter in length, than the placebo group.~     Children less than 10 years of age benefitted most from treatment and had fewer side effects.~      Based on these data, the FDA licensed interferon-gamma for prophylaxis in CGD patients. We~     wish to monitor our patients who participated in the original study for possible long-term~     side effects. Any new patients referred to us who are either on interferon-gamma or~     considered to be candidates for interferon-gamma will be considered for this protocol. In~     addition, our patients who were originally accepted under Genentech's compassionate plea~     protocol will also be monitored under this new protocol. The patients will be evaluated every~     six months, with blood work and interim medical histories taken.~   "
270431|NCT00001314|"~     In this study researchers plan to perform a diagnostic test called transesophageal~     echocardiography in order to see and record the movement and function of the heart.~      Transesophageal echocardiography is similar to an upper gastrointestinal endoscopy. Different~     views of the heart are taken by a small, flexible instrument positioned in the esophagus (the~     tube that connects the mouth to the stomach). This allows doctors to create a clear picture~     of the heart through the wall of the esophagus rather than from outside the body through the~     muscles, fat, and bones of the chest wall.~      During transesophageal echocardiography pictures of the heart will be taken while patients~     rest and as patients receive a medication called dobutamine. Dobutamine is a medication that~     makes the heart beat stronger and faster, similar to what exercise does to the heart.~      Researchers are particularly interested in studying patients with defects in the valves of~     the heart, especially aortic regurgitation and mitral regurgitation. Patients with these~     defects in the heart valves tend to develop abnormalities in the size and function of the~     left ventricle. The left ventricle is one of the four chambers of the heart responsible for~     ejecting blood out of the heart into the circulation. Researchers believe that by identifying~     changes in the function of heart muscle, they may be able to predict the occurrence of muscle~     damage due to the diseased valves.~      The purpose of this study is to determine whether the function of heart muscle measured~     during dobutamine stress transesophageal echocardiography can predict the later development~     of problems in the function and size of the left ventricle.~   "
270453|NCT00001229|"~     Pheochromocytoma is a tumor of the adrenal gland. This tumor is typically benign (not~     cancerous) and can be cured by surgical removal. However, pheochromocytomas produce~     neurohormones called cateholamines (epinephrine and norepinephrine). High levels of~     catecholamines can result in high blood pressure, headaches, sweating, heart palpitations,~     nausea, vomiting, and other symptoms. These tumors are considered dangerous because of their~     unpredictable behavior. Patients with pheochromocytoma may experience blood pressures high~     enough to cause a stroke or heart attack in patients.~      This study is designed to take patients suspected of having pheochromocytoma and confirm the~     diagnosis. This will be done using a variety of laboratory tests including a clonidine~     suppression test and glucagon stimulation test. These tests use drugs that can stimulate or~     reduce the activity of the tumor if it is present in the body.~      Once a diagnosis is confirmed, patients participating in this study will undergo standard~     procedures to find the exact location of the tumor and receive standard therapy for the~     condition.~   "
270699|NCT00045903|"~     This study will evaluate the effectiveness of two cognitive behavioral therapies (CBTs) in~     treating obsessive compulsive disorder (OCD) in patients who are taking medication but still~     have residual symptoms.~   "
270432|NCT00001311|"~     This study will test the effectiveness of an intraocular lens treated with heparin in~     reducing or preventing inflammation after cataract surgery in patients with uveitis.~      Patients with uveitis (inflammatory eye disease) often develop cataracts (clouding of the~     lens of the eye) that can impair eyesight. Cataracts can be removed surgically, and this is~     usually done when poor vision interferes with adequate daily functioning, or when the lens~     becomes too cloudy to evaluate the level of eye inflammation in uveitis-information needed to~     adjust medication dosages. After surgery, vision is corrected with special eyeglasses,~     contact lenses, or intraocular lenses (IOL). IOLs are small, plastic artificial lenses~     permanently placed inside the eye.~      Patients with uveitis who require cataract surgery and whose eye inflammation has been~     controlled by medicine for at least 3 months may be eligible for this study. Those enrolled~     in the study will be randomly assigned to one of two treatment groups: one group will have a~     standard IOL implanted during cataract surgery; the other will receive a heparin-treated IOL.~      Before surgery, patients will undergo standard preoperative tests, including chest X-ray,~     electrocardiogram, blood tests and urinalysis, as well as an eye examination that includes~     photography of the cornea, iris and retina. Additional tests and examinations to be done at~     the start of the study and at periodic follow-up visits for about 1 year may include:~     fluorescein angiography to evaluate the blood vessels of the retina; specular microscopy to~     examine the surface of the IOL; cell and flare measurements to evaluate inflammation, and~     ultrasound to examine the back of the eye.~   "
270433|NCT00001301|"~     Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during~     which time a number of different treatment protocols have been used. Approximately 110~     patients have apparently been cured of their lymphoma. The present protocol has no~     therapeutic component, but is designed to document the late effects that may have been~     encountered by our patients, either as a consequence of the disease or its treatment. In~     essence, patients who consent to participate will be asked a series of questions pertaining~     to the quality of their life and possible medical problems that they may be encountering. In~     addition, they will receive a complete physical examination and undergo non-invasive~     investigations designed to identify the presence of unsuspected late effects. Investigators~     in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will~     participate in the protocol. As a part of the study, blood samples will be obtained to~     investigate the possibility that predisposing genetic factors may be identifiable in the~     patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such~     abnormalities are detected, blood samples from family members will also be examined to~     determine whether the defect was inherited.~   "
270434|NCT00001300|"~     Randomized study. All patients must be randomized to treatment on Arms I and II within 3~     months of definitive surgery on Regimen A.~      Regimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing~     resection followed by involved-field irradiation using megavoltage equipment with or without~     electron boost.~      Arm I: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial~     Protection. Doxorubicin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Granulocyte~     Colony Stimulating Factor (Amgen), G-CSF,~      NSC-614629; and Mesna, NSC-113891.~      Arm II: Observation. No adjuvant chemotherapy.~   "
270435|NCT00001298|"~     High dose methotrexate with leucovorin rescue has demonstrated activity in numerous~     malignancies. Although high dose methotrexate is generally well tolerated, unpredictable~     life-threatening toxicity can occur. For patients who have markedly delayed clearance of~     methotrexate secondary to renal dysfunction, therapeutic options are few and are of limited~     efficacy. Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal~     glutamate residue. Carboxypeptidase-G2 could be used to rescue patients with renal~     dysfunction and delayed methotrexate excretion, as it provides an alternative to renal~     clearance as a route of elimination.~   "
270436|NCT00001296|"~     Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study~     and to standardize the technical aspects of the study. Subsequently, all patients are~     randomized to Arms I and II.~      Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic~     intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.~      Arm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response~     Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF,~     NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.~   "
270437|NCT00001292|"~     The purpose of this study is to identify the genes responsible for certain scaling disorders~     and other inherited skin diseases and to learn about the medical problems they cause. In some~     cases, these may include problems affecting organs other than the skin, such as the eyes,~     teeth and bones.~      Patients with inherited skin disorders, including Darier's disease (keratosis follicularis),~     lamellar ichthyosis, epidermolysis bullosa, cystic acne, and others, and their relatives may~     be eligible for this study. Patients will have a medical history, physical examination with~     particular emphasis on the skin, and routine blood tests. Additional procedures for patients~     and unaffected relatives may include:~        1. Blood sample collection~        2. Dental exam with X-ray of the jaw~        3. Eye examination~        4. X-rays of the skull, ribs, chest, hands, feet, spine, arms, or legs~        5. Bone density scan~        6. Photographs of the skin~        7. Skin biopsies (removal of a small tissue sample under local anesthetic)~        8. Buccal sample (gentle brushing inside the cheek to collect a cell sample) for gene~          studies~      Patients who request the results of their gene testing will be provided this information.~   "
270454|NCT00001218|"~     Our past ultrasound research has indicated a need for baseline normative tongue data against~     which to compare our disordered speech populations. Subjects with normal speech and hearing~     who represent different ages and sexes, will be studied with respect to tongue shape and~     movement patterns. Recently developed parameters such as curve fitting, curve averaging, and~     polar coordinates will be used to create baseline data categories. In addition, new~     parameters and improved instruments will be developed as previously to produce a data base~     which can be used across disciplines.~   "
270555|NCT00048464|"~     Patients will have immune cells collected and then expanded outside of the body. Patients~     will undergo standard treatment with high dose chemotherapy followed by peripheral blood stem~     cell transplantation. Three days following the transplant, patients will receive an infusion~     of a large number of expanded immune cells. The goal of the study will be to determine the~     safety as well as potential efficacy of this treatment.~   "
270438|NCT00001291|"~     This protocol will examine blood, synovial fluid and synovial tissue from patients with~     rheumatoid arthritis and other chronic inflammatory joint diseases to study genetic and~     immunologic factors involved in the cause, development and progression of these conditions.~     Synovial fluid is the lubricating fluid in joints. The synovial membrane is a delicate tissue~     lining the inner surface of joints, which, in arthritic conditions, thickens and becomes~     infiltrated with various types of cells.~      Patients with rheumatoid arthritis and certain patients with other forms of arthritis may be~     eligible for this study. Those enrolled will be followed periodically for follow-up and~     disease evaluation. They may undergo the following procedures:~        1. Synovial fluid aspiration, when medically indicated (for example, for joint swelling and~          inflammation). For this procedure, an area of skin around the joint is numbed with an~          anesthetic, and a needle is inserted into the joint to withdraw a small fluid sample.~        2. Periodic blood sampling, not to exceed 450 milliliters (15 ounces) during any 6-week~          period, for genetic studies of rheumatoid arthritis. The samples are usually taken at~          the same times that synovial fluid is withdrawn.~        3. Synovial tissues, collected by needle biopsy or during surgical procedures for~          arthroscopy (examination of the interior of the joint and repair of the joint) or total~          joint replacement. For the needle biopsy, the skin over the biopsy site is washed and~          anesthetized. A needle is inserted and fluid is aspirated. The biopsy needle is then~          inserted through the outer needle and a tissue sample is suctioned.~      Patients who qualify for other research studies may be invited to participate.~   "
270439|NCT00001287|"~     Chronic Inflammatory Demylinating Polyneuropathy (CIDP) is an autoimmune condition affecting~     the nervous system. Researchers believe the immune system begins attacking the cells covering~     nerves called myelin. The destruction of myelin causes muscle weakness, loss of sensation,~     abnormal levels of protein in the fluid surrounding the brain (CSF), and slowing of the~     nervous system. The disease progresses slowly and disables patients suffering from it.~      CIDP is treated with steroids, plasmapheresis, and immunosuppressive drugs. Many patients~     initially respond to these treatments, but develop resistance to the therapy or experience~     side effects causing the treatments to be stopped.~      Researchers believe that intravenous immunoglobulin (IVIg) may provide patients with CIDP a~     safer and more effective alternative to standard therapies for the disease. IVIg is a drug~     that has been used successfully to treat other immune-related diseases of the nervous system.~     However, because IVIg is so expensive, researchers believe it should first be proven~     effective on a small group of patients.~      The study will take 60 patients with CIDP and divide them into two groups. Group one will~     receive 2 injections of IVIg once a month for three months. Group two will receive 2~     injections of placebo inactive injection of sterile water once a month for three months.~     Following the three months of treatment, group one will begin taking the placebo and group~     two will begin taking IVIg for an additional 3 months. The drug will be considered effective~     if patients receiving it experience a significant improvement (>25%) in muscle strength.~   "
270440|NCT00001285|"~     For many years researchers have been trying to better understand the regulation of sleep and~     activity by studying circadian (daily) rhythms of human beings. It appears that the hormones~     estrogen, progesterone, and testosterone play a role in the regulation of circadian rhythm in~     animals. Researchers believe these hormones may also play a similar role in the regulation of~     human circadian rhythms. Little research has been conducted on how these hormones affect~     human circadian rhythms.~      This study is designed to learn more about how specific hormones influence men and women's~     daily rhythms. This study will use women from another research study being conducted at the~     NIMH called, The central nervous system effects of pharmacologically induced~     hypogonadotropic hypogonadism with and without estrogen and progesterone. Male subjects will~     be recruited from another NIMH study called, The central nervous system effects of~     pharmacologically induced hypogonadotropic hypogonadism with and without testosterone~     replacement.~      In order to test the possibility that gonadal steroids (estrogen, progesterone, and~     testosterone) change circadian rhythms and the sleep-wake cycle in humans, participants will~     undergo chronobiologic evaluations. The chronobiologic evaluations will look at sleep and~     rest periods, activity as measured by a wrist monitor, and 24 hour inpatient~     electroencephalograph (EEG), rectal temperature, and melatonin monitoring.~   "
270441|NCT00001280|"~     This protocol describes a prospective, randomized study examining the safety and efficacy of~     Itraconazole for preventing fungal infections in patients with Chronic Granulomatous Disease~     (CGD). CGD is a genetic disorder in which phagocytes are unable to produce oxygen radicals.~     As a result, affected patients are prone to recurrent, severe infections with bacterial and~     fungal organisms. Patients with CGD of 5 or more years of age without evidence of infection~     at the time of study entry will be eligible for enrollment. Patients will be randomized to~     receive itraconazole or placebo tablets daily, in a double blinded fashion. In addition to~     itraconazole, all patients will receive antimicrobial prophylaxis against bacterial~     infection, and may in addition receive gamma-interferon as prophylaxis against infection.~     Randomization of patients will be stratified among patients receiving or not receiving gamma~     interferon. The primary endpoint of the study will be the development of culture or~     histologically proved invasive fungal disease. Patients will be monitored every three months~     for evidence of drug toxicity. The anticipated accrual period will be approximately 36-48~     months.~   "
270455|NCT00001217|"~     The study is designed to determine if the administration of multi-drug adjuvant chemotherapy~     for patients with primary non-metastatic osteogenic sarcoma, both prior to and after the~     definitive surgical procedure for their primary tumor is superior as a treatment strategy to~     the current approach of giving drugs only after the definitive surgical procedure has been~     performed. An effort will be made as well to determine if the administration of~     pre-definitive surgery, chemotherapy leads to an increase in the proportion of the patients~     suitable for a limb salvage primary surgical procedure.~   "
270456|NCT00001216|"~     This study is designed to allow researchers to use transelectrical stimulation to explore the~     function of the human nervous system and improve diagnosis of neurological disorders.~      Transcranial electrical stimulation is a non-invasive technique that can be used to stimulate~     brain activity and gather information about brain function. Electrical stimulation involves~     placing electrodes on the scalp or skin and passing an electrical current between them. When~     this is done, an electrical field is created that activates areas of the brain that control~     muscles. Muscle activity as a result of the stimulation can be recorded and analyzed.~   "
270442|NCT00001278|"~     The purpose of this study is to develop a relatively simple, accurate method of diagnosing~     sarcoidosis. Sarcoidosis is a disease in which granulomas (nodules of inflamed tissue)~     develop in various organs, such as the lungs, liver, skin and eyes. Disease symptoms vary~     depending on the tissues involved. Many patients develop uveitis (eye inflammation). Tissue~     biopsy-often a costly and difficult invasive procedure-is currently the only definitive~     diagnostic test for sarcoidosis. Other tests, such as blood and urine tests, do not provide~     definitive results.~      Patients with uveitis that is 1) known to be due to sarcoidosis; 2) suspected to be due to~     sarcoidosis based on specific diagnostic criteria; and 3) known not to be due to sarcoidosis~     may be enrolled in this study. Participants will undergo an eye examination, blood tests,~     chest X-ray, and skin test for tuberculosis and other infections. Small tissue samples from~     the conjunctiva (the thin lining covering the outside of the eye and the inside of the~     eyelid) and the lacrimal (tear) gland will be taken after the eye is numbed with anesthetic~     drops and injection.~      Investigators will examine and compare levels of certain proteins in the biopsied tissues~     from the three patient groups to see if elevated levels of these substances may indicate~     granuloma formation. Development of a new, relatively simple diagnostic test for sarcoidosis~     based on these findings may permit doctors to start appropriate therapy earlier in the course~     of disease without invasive biopsy.~   "
270443|NCT00001272|"~     This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the~     two drug combination which now comprises the standard of care in newly diagnosed advanced~     stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose~     intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with~     ovarian cancer will be treated with this regimen to determine the optimal dose of this~     combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.~   "
270444|NCT00001271|"~     Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr~     infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of~     response.~   "
270445|NCT00001270|"~     This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with~     autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid~     cancers. The initial goal of this study was to define the toxicity of interleukin-1~     administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated~     with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second~     cohort of 18 patients also received G-CSF and engraftment was further shortened in some~     subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF.~     Accrual will continue to further define the toxicity and efficacy of this regimen.~   "
270446|NCT00001269|"~     This is a phase I study to determine the maximal tolerated dose of IL-3 given alone or~     sequentially with GM-CSF following FLAC chemotherapy in metastatic breast cancer patients.~   "
270447|NCT00001267|"~     Several dideoxynucleosides have now been shown to have activity against HIV but to have~     different toxicities. This study will involve therapy of patients with AIDS or ARC with two~     of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles,~     over a 2-year period of time. The rationale for using the two drugs will be to reduce~     toxicity and also possibly to delay or prevent the development of resistance. Patients will~     be randomized to receive either an alternating regimen or a continuous simultaneous regimen~     with these two drugs. The study will be structured as a randomized pilot study.~   "
270448|NCT00001249|"~     The study purpose is to evaluate the clinical response to multidose administration of~     anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult~     T-cell leukemia (ATL).~   "
270449|NCT00001239|"~     To evaluate a dose intensive chemotherapy regimen for the treatment of locally advanced and~     metastatic breast cancer using granulocyte-macrophage colony-stimulating factor (GM-CSF) to~     ameliorate chemotherapy-induced toxicity. Combination chemotherapy consists of Flurouricil,~     Leucovorin, Adriamycin, and Cytoxan (FLAC) which will be given every 21 days for 10 cycles.~     This protocol will replace the phase I study of this regimen (MB-232/88-C-0207) which found~     the MTD of this regimen to be at the first dose level. This is a phase II study to determine~     response rates of this regimen in advanced breast cancer.~   "
270450|NCT00001237|"~     Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place~     in the last ten years. Though the survival rate in low risk patients (i.e., those with stage~     I & II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous~     Pediatric Branch protocol, only 32% of patients in the high risk group achieved long term~     remission. The present protocol is designed to improve survival in the high risk group by~     using alternating non-cross resistant drug regimens. We plan to determine whether using~     granulocyte-macrophage colony stimulating factor (GM-CSF) in this group would increase~     dose-intensity and ameliorate myelotoxicity. We also plan to study the effect on survival of~     decreasing the duration of treatment to three months from the present year-long therapy in~     low-risk patients.~   "
270451|NCT00001233|"~     A conduct disorder is characterized by repetitive and persistent patterns of behavior where~     the basic rights of others and rules are violated.~      This study investigates characteristics of children and their surroundings (environments)~     that place them at risk for the development of disruptive behavior disorders and associated~     disorders of anxiety and mood. Children ages 4 - 5 with moderate (subclinical) and severe~     (clinical) rates of misconduct during the preschool period are compared to low risk children.~     Children and their families were recruited from 1989-1991 and are being studied at five~     specific times:~        1. Preschool (4 - 5 years)~        2. Early childhood (6 - 7 years)~        3. Middle childhood (9 - 10 years)~        4. Early adolescence (13 - 14 years)~        5. Mid-adolescence (15 - 16 years)~      Researchers will look closely at biological, intellectual, emotional, and behavioral factors~     that are thought to protect against and/or increase the risk of developing a conduct problem.~     These factors have been studied in older children and are shown to be associated with~     disruptive behavior disorders.~      The goals of this research study are;~        1. Create a database showing the characteristics of the development of disruptive behavior~          problems.~        2. Identify the key risk and protective factors that contribute to the stability or change~          in behavior problems over time.~        3. Identify the ways that children interact socially and relate them to the possibility of~          developing a problem of behavior.~        4. Identify how experiences and the emotions associated with experiences may play a role in~          the development of related psychiatric conditions, like depression and anxiety.~        5. Establish measures of the different components of negative emotions associated with~          disruptive/antisocial, anxiety, and mood disorders.~   "
270468|NCT00001153|"~     To study the relationship between visual function and ocular (iris, retina/choroidal)~     pigmentation in patients with albinism and other hypomelanotic disorders. To identify the~     carrier state in relatives of patients with ocular albinism.~   "
270469|NCT00001152|"~     To compare patients having PDS without and with OH or GL by documenting and following the~     clinical features and course of their disease and evaluating the patient's performance on a~     variety of diagnostic tests.~   "
270457|NCT00001211|"~     The amendment to Clinical Protocol 86-D-0015, clinical study of Oral Endosseous Titanium~     Implants in Edentulous subjects, and patients with Ectodermal Dysplasia is to allow the~     Investigators to determine: (1) If placement of Endosseous Titanium Implants in~     pre-adolescent patients (age 7 to 10) will influence the growth and development of the~     craniomandibular complex. (2) The final position of the implant, the ability to fabricate~     prosthesis. (3) Body image, diet and perceived ease of chewing selected foods.~      Selection of patients for participation in the study will be based on the number of~     congenitally missing teeth associated with Ectodermal Dysplasia. At least 16 permanent teeth~     must be congenitally missing. A total of 30 patients will be included.~      A consent to participate in this study will be obtained from each patient:~      18 & older - consent signed by patient~      13-17 years - consent signed by parent, assent signed by patient~      7-10 years - consent by parent, assent signed by child if capable of understanding or note on~     chart describing procedure used to obtain the child's assent to the study~   "
270458|NCT00001210|"~     Subjects are healthy adult volunteers either at high risk for HIV infection or already known~     to be seropositive, who will donate blood for in vitro tests of T-cell function and in vitro~     responses to synthetic peptides corresponding to sequences from HIV proteins.~   "
270459|NCT00001209|"~     This protocol is designed to test the feasibility of the administration of vincristine,~     adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well~     as the efficacy of this therapy in addition to radiotherapy in producing complete responses~     and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone,~     peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but~     will be comparable to the large data base of similar patients treated on successive Pediatric~     Branch studies.~   "
270460|NCT00001194|"~     This protocol is designed to investigate the use of novel techniques in MRI that may not yet~     be commercially available. Specifically, the protocol enables patients to take advantage of~     new pulse sequence software, coil design or post processing capabilities not otherwise~     available. The informed consent explains MRI in lay terms, describes the use of contrast~     agents and lists contraindications to MRI.~   "
270461|NCT00001193|"~     This study is designed to evaluate the efficacy of high dose melphalan and autologous bone~     marrow transplantation given as consolidation therapy to patients with inflammatory or~     metastatic carcinoma of the breast in complete remission. All patients entered will receive~     induction therapy with cyclophosphamide, adriamycin, methotrexate and 5-fluorouracil with~     hormonal synchronization utilizing tamoxifen and premarin as in a previous Medicine Branch~     protocol (MB-160C). Among patients with inflammatory carcinoma of the breast, pathologic~     complete responders will receive irradiation to the breast and regional lymph nodes;~     convertible partial responders and clinical complete responders with residual disease on~     biopsy will undergo surgical resection of bulk disease followed by irradiation of the chest~     wall and regional lymph nodes excluding the axilla. Both groups of responders will be~     randomized to receive either systemic consolidation therapy with high dose melphalan (180~     mg/M2 total dose over 3 days) and autologous bone marrow transplantation followed by~     maintenance therapy or maintenance therapy alone. Complete responders in this noninflammatory~     group will not receive further therapy since, historically, they have done well following~     induction and local therapy, with maintenance therapy alone.~      Patients with metastatic breast cancer will be assessed for response throughout induction~     therapy. Complete and convertable partial responders will receive consolidative therapy and~     be randomized to ABMT followed by 6 months of maintenance therapy vs. maintenance alone.~   "
270462|NCT00001189|"~     Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue~     tumors will receive wide local excision and be prospectively randomized as to either receive~     or not receive radiation therapy.~   "
270463|NCT00001188|"~     Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to~     either receive or not receive radiation therapy following surgery for the removal of the~     local tumor. All patients in this protocol will receive adjuvant chemotherapy.~   "
270464|NCT00001173|"~     One of the major interests of this laboratory is the characterization of the cellular~     subpopulations involved in the triggering and immunoregulation of B lymphocytes to produce~     antibodies. We are assessing the responses of individuals to produce antibodies against newly~     encountered antigens such as keyhole limpet hemocyanin (KLH) (approved project number~     77-I-0130) and propose to assess the amnestic responses to the previously encountered~     antigen, tetanus toxoid. The purpose of this protocol is to add this recall antigen to our~     repertoire of antigens used to evaluate the immune response in man.~      Booster immunization with tetanus/diphtheria toxoid has now been used for several years by a~     number of clinical immunology laboratories throughout the country to assess B cell related~     immunologic profiles in patients and control normal subjects. We have recently developed a~     sensitive ELISA assay for IgM and IgG in vitro specific antibody responses against tetanus~     toxoid. This will allow us to carefully and precisely monitor the evolution and~     immunoregulation of the human B cell responses to this recall antigen. This is of particular~     importance and relevance to us in our ongoing studies of a number of diseases characterized~     by abnormalities of immunologic reactivity, including those treated with various regimens of~     immunosuppressive agents.~   "
270465|NCT00001169|"~     Mechanisms of host immune response to intracellular protozoa will be investigated in patients~     with naturally acquired infection employing a variety of in-vitro techniques. Both~     non-specific and antigen-specific humoral and cellular immune responses will be assessed.~     Parasites will be isolated from patients, cultivated in-vitro, and characterized. Responses~     to chemotherapy will be assessed parasitologically, immunologically and clinically.~   "
270466|NCT00001164|"~     It is proposed that patients with skin disease due to presumed immunologic, genetic or~     viral-induced abnormalities, patients with neurological degenerations, and normal controls be~     evaluated with various in vitro studies of immunologic, genetic, and virologic function. This~     is to include studies of peripheral blood (cells and serum) as well as studies of skin~     obtained with a biopsy instrument. In addition, studies of gastrointestinal function will be~     performed where appropriate.~   "
270467|NCT00001158|"~     The goal of the protocol is to define the normal humoral and cellular immune responses to~     antigens in volunteers and to define abnormalities of these immune responses in patients with~     immunodeficiency diseases or cancer. In vitro assays and in vivo skin tests and immunization~     with antigens will be utilized.~   "
270470|NCT00001142|"~     Some HIV-infected adults develop lipodystrophy that includes significant changes in body~     shape, with fat losses in the face, arms and legs, and fat gain in the trunk. This~     lipodystrophy is often accompanied by other disorders of metabolism, such as increased levels~     of fat and insulin in the blood.~      The majority of these cases have been seen when patients are taking medications called~     protease inhibitors. These are anti-retroviral medications designed to treat patients with~     HIV. It is unclear if lipodystrophy is a result of having HIV or the medication used to treat~     HIV. It has been suggested, but not proven, that lipodystrophy is a direct side effect of~     protease inhibitors. In addition, it is unknown if HIV-infected children develop significant~     lipodystrophy after taking protease inhibitors.~      This study will investigate the prevalence of metabolic disorders and changes in body fat~     distribution in children taking protease inhibitor anti-retroviral medications. The results~     will be compared to three other groups; (1) children suffering from other non-HIV chronic~     infections, (2) HIV-infected children not taking protease inhibitors, and (3) healthy~     children.~      The study will look at HIV-infected children who have already started taking protease~     inhibitors. It will evaluate these children for disorders in metabolism as well as body fat~     changes. In addition, the study will follow HIV-infected children who will begin taking~     protease inhibitors. The study will follow these children for 18 months to detect the~     development of disorders in metabolism and / or body fat changes.~   "
270471|NCT00050388|"~     The purpose of this clinical trial is to determine if Allovectin-7®, an experimental~     gene-based immunotherapy, can shrink head and neck tumors. The trial will also examine if~     treatment can boost the immune system and if this treatment can improve the time to disease~     progression.~   "
270472|NCT00050375|"~     This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated~     patients and placebo-treated patients. This study will also compare assessments of survival,~     quality of life, immune response and safety between active and placebo groups.~   "
270473|NCT00050362|"~     This study will evaluate the ability of the drugs rofecoxib and bupivacaine to prevent pain~     following third molar (wisdom tooth) extraction. Rofecoxib is approved to treat pain of~     arthritis and menstrual cramps. Bupivacaine is a local anesthetic similar to lidocaine, but~     longer acting.~      Healthy normal volunteers between 16 and 35 years of age who are in general good health and~     require extraction of their two lower wisdom teeth may be eligible for this study.~      Participants will have their two lower wisdom teeth extracted, and a biopsy (removal of a~     small piece of tissue) will be taken from the inside of the cheek around the area behind one~     of the extraction sites. Ninety minutes before surgery, patients will take a dose of either~     rofecoxib, or a placebo (a pill with no active ingredient) by mouth. Just before surgery,~     they will receive an injection of either lidocaine or bupivacaine to numb the mouth and a~     sedative called midazolam (Versed® (Registered Trademark)) through an arm vein to cause~     drowsiness. After surgery, a small piece of tubing will be placed into one of the two~     extraction sites. Samples will be collected from the tubing to measure chemicals involved in~     pain and inflammation.~      Patients will remain in the clinic for up to 4 hours after surgery to monitor pain and drug~     side effects while the anesthetic wears off. During this time, they will complete pain~     questionnaires every 20 minutes. (Patients whose pain is unrelieved an hour after surgery may~     request and receive acetaminophen (Tylenol) and codeine.) The tubing then will be removed and~     they will be discharged with pain medicines (Tylenol, codeine and the study drug) and forms~     to record pain ratings. They will be given detailed instructions on how and when to take the~     medicines and how to record information in the pain diary.~      Patients will return to the clinic 48 hours after surgery with the pain diary and pain~     relievers. At this visit, another biopsy will be taken under local anesthetic (lidocaine).~   "
270474|NCT00050349|"~     This study will examine whether the new investigational drug EPO906, given by intravenous~     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the~     growth of cells that cause metastatic carcinoid and other neuroendocrine tumors.~   "
270475|NCT00050336|"~     The purpose of this study is to determine the overall survival of patients diagnosed with~     Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein~     Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin~     with that of patients treated with placebo in combination with paclitaxel and carboplatin.~   "
270476|NCT00050323|"~     The primary purpose of this study is to determine the safety of injections prepared from~     donor blood cells fused to a patient's own tumor cells which are then used to treat advanced~     (Stage IV) kidney cancer (renal cell carcinoma or RCC). The study will also explore the~     effect the injections have on the size of the tumor and the response in the patient's immune~     system following administration.~   "
270477|NCT00050310|"~     This study will examine pathophysiology and immune response of anthrax in infected or exposed~     individuals to learn more about the disease symptoms, prevention and response to treatment.~     In addition, it will evaluate immune response to the anthrax vaccine AVA (Anthrax Vaccine~     Adsorbed) in healthy, non-infected individuals.~      The following individuals may be eligible for this study:~        1. People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal,~          either acute or recovering);~        2. People exposed to anthrax who have no clinical symptoms.~        3. Healthy people who have not been exposed to anthrax and have been vaccinated with AVA.~      Those enrolled in the study will undergo the following tests and procedures.~      Infected and exposed individuals:~        -  Symptomatic participants will have the following clinical procedures if medically~          necessary:~        -  a) blood tests for cell counts, chemistries and evidence of anthrax bacteria;~        -  b) nasal swab to test for evidence of anthrax~        -  c) chest X-ray;~        -  d) computed tomography (CT) scan (special X-rays to examine the lungs or abdomen);~        -  e) echocardiogram to examine the heart~        -  f) magnetic resonance imaging (MRI), a special imaging test using a magnetic field and~          radio waves to examine the infected area of skin and soft tissue for patients with~          cutaneous anthrax.~        -  All subjects (with or without symptoms) will have the following research procedures:~        -  a) blood tests to examine immune response to anthrax;~        -  b) throat swab to test for evidence of anthrax~        -  c) nasopharyngeal wash to test for anthrax. Water is sprayed into the nostrils and then~          allowed to drain for collection in a cup;~        -  d) induced sputum to test for presence of and immune response to anthrax. A mask with a~          saline mist is placed over the subject s mouth and nose, causing the subject to cough~          and produce sputum from the lungs. The sputum is collected in a cup this is for~          individuals 18 and older who do not undergo bronchoscopy, described below.~        -  Participants 18 years of age and older may have the following optional research~          procedures:~        -  a) leukapheresis or plasmapheresis (see description under non-infected, vaccinated~          individuals above);~        -  b) lymph node biopsy. A sample of lymph node tissue is surgically removed under local~          anesthetic;~        -  c) bronchoalveolar lavage. This 15- to 30-minute procedure is done in the intensive care~          unit. The mouth, nasal passages, throat and airways are numbed with lidocaine and a thin~          flexible tube is passed through the nose into the lung airways. Samples of cells and~          secretions are obtained by rinsing (lavage) the airways with salt water. The fluid is~          analyzed for infection, inflammatory cells and inflammatory chemicals.~      All infected and exposed individuals will have periodic medical history and physical exam~     evaluations and be offered treatment or prophylaxis (treatment to prevent infection) with~     antibiotics, according to the guidelines of the Centers for Disease Control and Prevention~     (CDC). Patients will be monitored for at least 24 months after antibiotic treatment, or~     longer if circumstances warrant.~      Non-infected, vaccinated individuals~        1. medical history and physical examination~        2. blood tests-- between 10 and 50 ml (2-10 teaspoons) of blood will be drawn at a time,~          and not more than 450 ml will be taken in a 6-week period. Based on the blood test~          results, other optional research procedures may be requested~        3. leukapheresis to collect white blood cells and plasmapheresis to collect plasma (the~          liquid part of the blood). For both of these procedures, blood is collected through a~          needle placed in an arm vein. The blood flows into a special machine that separates it~          into its components by spinning. The desired components (white cells or plasma) are~          removed and the rest of the blood is returned to the body through the same needle or a~          second needle in the other arm.~   "
270478|NCT00050297|"~     The purpose of this study is to determine the optimal dosage of YM598 for slowing down~     disease progression in patients with rising PSA after initial therapy for localized prostate~     cancer.~   "
270479|NCT00050284|"~     The purpose of this study is to determine whether patients who have asymptomatic HIV~     infection can discontinue antiretroviral therapy (ART) without adverse clinical, virologic,~     or immunologic consequences. This study will also assess the virologic, immunologic, and~     clinical outcomes in any patients who restart ART.~   "
270480|NCT00050271|"~     The purpose of this study is to determine if acetyl-L-carnitine (ALC) reduces pain, numbness,~     and tingling in the feet and legs of patients with nucleoside reverse transcriptase inhibitor~     (NRTI)-associated peripheral neuropathy. Another purpose is to determine if ALC is safe and~     tolerable in HIV patients who have taken certain anti-HIV drugs.~   "
270490|NCT00050128|"~     This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation~     (TMS), together with exercise, for rehabilitation of chronic stroke patients. It will~     identify the optimum stimulation settings (within the limits of current safety guidelines) to~     be used in a later rehabilitation study and confirm the safety of the procedure at these~     settings. Some previous studies using TMS to treat movement disorders such as Parkinson's~     disease have shown improvement in motor function; others have not. The results of this study~     may provide information to help researchers design better rehabilitation treatments after~     stroke.~      Stroke patients with residual arm function and no history of seizures may be eligible for~     this study. The stroke must have occurred at least 6 months before entry into the study and~     must have affected only one side of the brain.~      For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on~     a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical~     current is passed through the coil, creating a magnetic pulse that stimulates the outer part~     of the brain, called the cortex. This may cause muscle, hand or arm twitching if the coil is~     near the part of the brain that controls movement, or it may affect movements or reflexes.~     Subjects are asked to make movements, do simple tasks, or tense muscles. Metal electrodes are~     taped to the skin over the muscle for computer recording of the electrical activity of the~     hand and arm muscles activated by the stimulation. The testing lasts 2-3 hours.~   "
270481|NCT00050245|"~     This study will test the safety and effectiveness of the drug Rituximab in treating a nerve~     disease called MGUS (also known as neuropathy with anti-MAG antibodies). Patients with MGUS~     have an abnormal protein called monoclonal IgM immunoglobulin that attacks the myelin sheath~     (protective coating) of nerves, causing them to not function properly. The disease affects~     the nerves in the legs or arms, and patients have numbness, tingling, muscle weakness, and~     unsteady gait. There are no adequate treatments. Immunosuppressive drugs or human~     immunoglobulin infusions can produce mild and transient improvement, but the benefits of~     these therapies are not significant.~      The abnormal immunoglobulin protein in MGUS is produced by white cells called B lymphocytes.~     Rituximab is approved to treat B cell lymphomas. Also, the drug showed promise in a recent~     study of patients with demyelinating neuropathy associated with production of antibodies from~     B lymphocytes directed against certain nerve proteins. Although the number of patients~     treated with Rituximab was small, the drug was well tolerated and caused significant~     improvement in several of the patients.~      Patients 25 years of age and older with MGUS may be eligible for this 2-year study.~     Candidates will be screened with a medical history, physical and neurological examinations,~     and blood tests.~      Participants will be randomly assigned to receive intravenous (through a vein) infusions of~     either Rituximab or placebo (a solution that looks like Rituximab but has no active~     ingredient) once a week for 4 consecutive weeks. In addition, they will undergo the following~     tests and procedures:~        -  Monthly follow-up visits following Rituximab treatment for repeat physical and~          neurological examinations, blood tests, muscle strength measurements, and review of~          signs and symptoms.~        -  Two sessions of lymphapheresis, one at the beginning of the study and one a year~          later-to collect lymphocytes. For this procedure, whole blood is drawn through a needle~          in an arm vein, much like donating a unit of blood. The blood then flows through a~          catheter (plastic tube) into a cell separating machine, where the white blood cells are~          extracted and removed. The red cells and plasma are then returned to the body through a~          needle in the other arm. The procedure takes about 60 to 90 minutes.~        -  Electrophysiologic studies (electromyography and nerve conduction testing) are done once~          at the beginning of the study and again one year later. For electromyography, a small~          needle is inserted into a few muscles and the patient is asked to relax or to contract~          the muscles. The electrical activity of the muscle cells is recorded and analyzed by a~          computer. For nerve conduction testing, nerves are stimulated through small wire~          electrodes attached to the skin and the response is recorded and analyzed.~      If this study indicates that Rituximab is beneficial against MGUS, patients who were assigned~     to receive placebo during the trial will be offered treatment with Rituximab (four weekly~     infusions) at the end of the study.~   "
270482|NCT00050232|"~     Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying~     out of proportion. Other terms used to describe this condition include emotional lability,~     emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and~     pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the~     reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923~     in the treatment of MS patients suffering from pseudobulbar affect.~   "
270483|NCT00050219|"~     This study will examine the role of the brain chemical dopamine in people's response to~     alcohol consumption. Dopamine is thought to influence whether people have a strong or weak~     response to alcohol and how pleasurable that response is. The findings of this study may shed~     light on why some people are at higher risk of developing problem drinking behaviors.~      Healthy normal volunteers between 21 and 25 years of age who have never had a serious problem~     with alcohol abuse or drug abuse may be eligible for this study. Candidates will be screened~     with a medical history and physical examination, and will be interviewed about their smoking~     and drinking behaviors. Participants will undergo test procedures on two separate days, as~     follows:~      Test Day 1~      Upon arrival at the Clinical Center, participants will take a breathalyzer test for alcohol~     and provide a urine sample for a drug screen. Women will also have a urine pregnancy test.~     They will then lie on a hospital bed and two intravenous catheters (IV lines) will be placed,~     one into each arm. One line will be used to collect blood samples during the test session;~     the other will be used to infuse alcohol into the bloodstream. The alcohol will rapidly~     increase the blood alcohol level to between 0.06 and 0.08 grams per deciliter. (0.08 g/dL is~     the level at which a person is charge with driving under the influence of alcohol in all~     States.) Before, during, and after the infusion, subjects will be asked about their feelings~     in response to the alcohol, such as confusion, elation, level of discomfort or dizziness,~     ability to concentrate, and so forth. At 35 and 60 minutes after the infusion begins,~     subjects will take a body sway test. This involves standing on a machine to determine how the~     alcohol has affected the sense of balance. Subjects will then relax in the clinic for a few~     hours. During this time, a blood sample will be collected and a questionnaire will be given~     hourly until the blood alcohol level has gone down to 0.02 g/dL. When the alcohol level has~     declined to 0.02 g/dL (usually 3 to 4 hours after the infusion), the subject will be sent~     home in a taxi.~      Test Day 2~      Participants will again take a breathalyzer test for alcohol and provide a urine sample for~     drug screen and, for women, a pregnancy test. Subjects will lie on a hospital bed and three~     IV lines will be inserted, one to draw blood samples, one to infuse alcohol, and one to give~     raclopride, a radioactive substance used for positron emission tomography (PET) scanning. For~     PET, the subject lies on a table in the scanner with a mask placed over his or her head to~     help hold the head still during the scan. After a brief scan to adjust the machine, a small~     amount of radioactive water (O-15 water) is injected through the IV line and a series of~     pictures is taken over a period of about 1 minute. These images show how the radioactive~     water distributes in the brain, indicating blood flow. After the water scan, raclopride is~     given through the IV line and more pictures of the brain are taken over the next 2 hours.~     Blood samples are collected during and after the raclopride scan. During this procedure,~     subjects are asked the same questions about their feelings in response to the alcohol as they~     did during the earlier session. After he scans, they will be monitored in the clinic with~     hourly blood tests and questionnaires until the blood alcohol concentration decreases to 0.02~     g/dL and will then be sent home in a taxi.~   "
270484|NCT00050141|"~     The purpose of this study is to determine if the addition of tipifarnib to standard letrozole~     therapy leads to a better response to treatment for your cancer in comparison to letrozole~     plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors~     (FTI). It blocks proteins that make cancer cells grow.~   "
270485|NCT00050206|"~     The purpose of this study is to determine the efficacy (how well the drug works), safety, and~     any side effects of olanzapine compared to placebo in the treatment of mania in bipolar~     disorder in adolescents. Both the potential benefits and side effects of olanzapine will be~     evaluated throughout this trial.~   "
270486|NCT00050167|"~     Primary Objectives:~        -  Determine the impact of each regimen on the disease free and overall survival of~          patients with operable breast cancer.~        -  Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when~          administered in the neoadjuvant setting when compared with weekly paclitaxel.~        -  Determine the ability of each regimen to enhance breast conservation therapy when~          administered in the neoadjuvant setting. (See protocol text for additional objectives~          and details).~   "
270487|NCT00050193|"~     This study will evaluate children with mastocytosis, a disease of excessive mast cells in~     tissues such as skin and bone marrow, to identify the cause of the disease and describe its~     course. Mast cells can release chemicals that cause itching, blisters, flushing, bone pain,~     and abdominal pain. Usually, mastocytosis in children involves the skin only and is of~     limited duration. This study, however, will focus on children with more severe disease that~     more closely resembles adult-onset mastocytosis.~      Patients up to 21 years of age with childhood-onset mastocytosis may be eligible for this~     study. Candidates must have one or more of the following abnormalities, which indicate severe~     disease: enlarged liver or spleen; diffuse skin involvement; history of gastrointestinal~     bleeding or peptic ulcer; bone marrow biopsy with abnormal mast cells either in number or~     shape; elevated blood levels of the enzyme tryptase; or abnormal hemoglobin, white blood~     cells, platelets, or clotting factors.~      Participants will have a medical history and physical examination; various blood tests,~     including studies to identify genetic changes that are important in the growth, development,~     and functioning of human mast cells; and bone marrow aspiration and biopsy. For the bone~     marrow procedure, the skin over the hipbone and the outer surface of the bone itself are~     numbed with an injection of local anesthesia. Then, a special needle is inserted into the~     hipbone and about 2 tablespoons of bone marrow are drawn into a syringe. Another needle is~     then inserted through the first needle to collect a small piece of the bone marrow. Pain will~     be managed according to the individual patient s needs. Additional procedures, such as a~     gastroenterology consultation, colonoscopy to examine the colon, or computerized axial~     tomography (CT) or ultrasound of the abdomen to assess the liver and spleen, may be done if~     medically indicated. Standard medical treatment, including antihistamines for itching or~     steroids for abdominal cramping or diarrhea, will be recommended as appropriate.~      Patients biologic parents may also be enrolled to provide a blood sample for genetic analysis~     and a bone marrow aspirate and biopsy for clinical and research purposes.~      Patients will return to NIH once a year for follow-up evaluations until their disease is~     stable or until the 5-year study ends.~   "
270488|NCT00050180|"~     This study will examine whether a particular type of gene (MDR1) in the body can affect blood~     levels of two protease inhibitors, indinavir and saquinavir, which are used to treat people~     with HIV. If blood levels of these drugs are too low or too high, they may not work well or~     may cause side effects in patients. This study will determine how MDR1 genes might affect~     absorption of these medicines.~      Healthy normal volunteers between 18 and 50 years of age may be eligible for this study.~     Candidates will be screened with a medical history and blood and urine tests. The blood will~     be tested for:~        -  Routine laboratory values for assessing general health~        -  HIV~        -  MDR1 gene type~        -  Amount of P-glycoprotein (a protein made by the MDR1 gene) on T cells.~      Participants will have blood drawn three more times, as follows:~        -  After one dose of the sedative midazolam (Versed(Registered Trademark)): Participants~          will take an 8-milligram dose of midazolam syrup by mouth. Four hours later, a single~          blood sample will be drawn through a needle in an arm vein. This part of the study will~          assess the efficiency of a certain enzyme involved in metabolizing (breaking down)~          indinavir and saquinavir.~        -  After four doses of indinavir: About a week after taking the midazolam, participants~          will take 800 mg of indinavir (two capsules) 3 times a day (every 8 hours) for 1 day.~          The following morning they will come to the clinic, where a catheter (flexible plastic~          tube) will be placed in an arm vein for repeated blood draws. A blood sample will be~          drawn, and a fourth and final dose of indinavir will be given. Seven blood samples of~          about a teaspoon each will then be collected through the catheter over an 8-hour period~          to measure blood levels of the drug.~        -  After 10 doses of saquinavir: About a week after the last dose of indinavir,~          participants will start taking 1,200 mg (6 capsules) of saquinavir soft-gelatin capsules~          3 times a day for 3 days. On the fourth day, participants will come to the clinic. A~          catheter will be inserted into an arm vein and about 4 teaspoons of blood will be~          collected for routine laboratory tests and to measure saquinavir levels. A urine sample~          will also be collected for routine tests. Participants will then receive the tenth and~          final dose of saquinavir, and eight blood samples of about a teaspoon each will be~          collected through the catheter over an 8-hour period.~   "
270489|NCT00050154|"~     The purpose of this study is to characterize the hematological response rate, as well as~     other parameters of efficacy and safety induced by tipifarnib in patients with high-risk~     myelodysplastic syndrome (MDS). Tipifarnib belongs to a class of drugs called Farnesyl~     Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.~   "
270556|NCT00048451|"~     The objective of this study is to determine whether paricalcitol is safe and effective~     compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney~     disease.~   "
270492|NCT00050089|"~     This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who~     have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including~     all three classes of anti-HIV drugs. The first randomization will allocate patients to an~     intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second~     randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4~     drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum)~     of follow-up; median duration of patient follow-up is about 4 years. The target sample size~     is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for~     the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24~     VA, 19 UK and 21 Canada.~   "
270493|NCT00050076|"~     The purpose of this study is to determine the effect of two different doses of MCC-135, once~     daily (QD) or twice daily (BID), on the disease state and the quality of life in subjects~     with congestive heart failure.~   "
270494|NCT00050063|"~     The purpose of this study is to determine whether therapeutic HIV vaccines can help the~     immune system control HIV viral load after anti-HIV drugs are discontinued.~   "
270495|NCT00050050|"~     This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating~     the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not~     responded to drug treatment.~      Study hypothesis: CBT is an effective treatment for adult ADHD.~   "
270496|NCT00050037|"~     The purpose of this study is to compare the efficacy of a CD-ROM-based cognitive-behavioral~     therapy (CBT) to traditional manual-based group therapy for obese individuals with~     binge-eating disorder (BED) and other unhealthy eating behaviors. A second goal is to~     encourage a healthy lifestyle in patients with BED.~   "
270497|NCT00050115|"~     This study will collect samples of blood, stool, bone marrow, or other tissues from patients~     with hepatitis-associated aplastic anemia to investigate a possible association between~     exposure to viruses and the development of aplastic anemia in these patients. Cells from the~     samples obtained may be grown in the laboratory for future studies. Patients samples may be~     used to:~        -  Study abnormalities that occur in hepatitis-associated aplastic anemia;~        -  Test for various viruses;~        -  Test immune function;~        -  Measure factors related to the patients disease or diseases they may be at risk for;~        -  Evaluate the effectiveness of current therapies, refine treatment approaches, and~          identify potential new therapies;~        -  Identify possible measures for disease prevention;~        -  Identify possible genetic factors associated with hepatitis-associated aplastic anemia.~      Patients 2 years of age and older with severe aplastic anemia that developed within 6 months~     of an episode of hepatitis may be eligible for this study.~      Participants will complete questionnaires and provide tissue samples as described below.~      Questionnaires~      All patients (or another respondent for the patient) will fill out a questionnaire including~     demographic information (age, gender, race, ethnic group, education level, state of~     residence), current symptoms, medications, medical history, and history of possible exposures~     to toxins or viruses. A second questionnaire, which includes questions related to mental~     health, sexual behavior, alcohol and drug use, is optional for participants age 21 and older.~     These questionnaires are designed to uncover features of hepatitis-associated aplastic anemia~     and possibly reveal a common cause of the disease.~      Sample Collections~        -  Blood- will be collected at the time of the patient s initial evaluation or upon~          enrollment into the study and possibly periodically during the study. Blood will be~          drawn through a needle in an arm vein.~        -  Bone marrow- may be collected as part of the patient s standard medical care or~          specifically for research purposes of this study. For this procedure, the skin over the~          hipbone and the outer surface of the bone itself are numbed with an injection of a local~          anesthesia. Then, a larger needle is inserted into the hipbone and marrow is drawn into~          a syringe. Marrow cells are suctioned two to six times during the 15-minute procedure.~        -  Stool- will be provided by the patient.~      Liver- tissue may be biopsied as part of the patient s general medical care or for NIH~     patients, as part of their enrollment in a treatment protocol.~   "
270498|NCT00050024|"~     This study will use transcranial magnetic stimulation (TMS) and electrical stimulation of~     nerves to examine how the brain controls muscle movement in focal hand dystonia (writer's~     cramp). Normally, when a person moves a finger, the brain's motor cortex prevents the other~     fingers from moving involuntarily. Patients with focal hand dystonia have difficulty with~     individualized finger movements, possibly due to increased excitability of the motor cortex.~     Musicians, writers, typists, athletes and others whose work involves frequent repetitive~     movements may develop focal dystonia of the hand.~      Healthy normal volunteers and patients with focal dystonia 18 years of age and older may be~     eligible for this study.~      For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on~     a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical~     current is passed through the coil, creating a magnetic pulse that stimulates the brain. This~     may cause muscle, hand or arm twitching if the coil is near the part of the brain that~     controls movement, or it may induce twitches or transient tingling in the forearm, head or~     face muscles. Subjects will be asked to move a finger. Just before this movement, a brief~     electrical stimulation will be applied to the end of either the second or fifth finger. Metal~     electrodes will be taped to the skin over the muscle for computer recording of the electrical~     activity of the hand and arm muscles activated by the stimulation. The testing will last 2-3~     hours.~   "
270499|NCT00050011|"~     This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6~     months when given upfront versus delayed start (based on a post-baseline BMD T- Score below~     -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to~     trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage~     I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive~     Letrozole 2.5 mg daily as an adjuvant therapy.~   "
270500|NCT00049998|"~     The purpose of this study is to collect information on how effective and how well tolerated~     an oral investigational drug is compared to a standard intravenous drug in patients with~     pretreated, advanced non-small lung cancer (NSCLC).~   "
270501|NCT00049985|"~     The purpose of this study is to determine whether increasing hemoglobin concentration in~     patients with heart failure and anemia will improve the patients' functional status,~     including exercise tolerance and New York Heart Association (NYHA) classification.~   "
270502|NCT00049972|"~     A study to obtain safety and tolerability data~   "
270503|NCT00049959|"~     The purpose of the two studies is to determine whether an experimental therapy using a~     photoactive drug, verteporfin, in combination with direct light exposure of basal cell~     carcinoma of the skin can safely eliminate these skin tumors.~   "
270504|NCT00049946|"~     A Placebo Controlled Study For Patients With Schizophrenia~   "
270505|NCT00049933|"~     To examine in postmenopausal women the potential interactions of hormone replacement therapy~     with other blood clotting factors on the risk of cardiovascular diseases such as heart attack~     or stroke.~   "
270506|NCT00049920|"~     To perform a follow-up study of cerebrovascular disease in the Atherosclerosis Risk in~     Communities (ARIC) magnetic resonance imaging subcohort.~   "
270507|NCT00049907|"~     To examine the epidemiology of renal disease and its relationship to cardiovascular disease.~   "
270508|NCT00049894|"~     To investigate mechanisms of recurrent stroke.~   "
270521|NCT00049738|"~     The purpose of this study is to screen and evaluate children with psychotic disorders to~     establish or confirm their diagnosis and to collect data about their condition. This study~     will also recruit individuals for various treatment studies.~      Childhood psychotic disorders are debilitating conditions in which children have auditory or~     visual hallucinations and disorganized thoughts. This study will examine psychotic disorders~     in children in an inpatient setting.~      Participants in this study will be admitted to the NIH Clinical Center for up to 9 weeks~     under one or more of the following conditions: current medication, no medication, or tapered~     medication. Participants will undergo blood, urine, metabolic, and intellectual functioning~     tests. An electrocardiogram (EKG) and electroencephalogram (EEG) will be performed. A~     magnetic resonance imaging (MRI) scan of the brain will be taken and infrared oculography~     will be used to measure eye movements. Participants and their family members may also be~     asked to participate in a study of genetics in children with psychotic illnesses. Children~     meeting criteria for childhood onset schizophrenia may be offered participation in a~     medication comparison protocol.~   "
270522|NCT00049725|"~     This study will evaluate the effectiveness of the drug daclizumab for treating patients with~     chronic immune thrombocytopenia (ITP), a disease in which the immune system destroys~     platelets (blood cells involved in the clotting process). Patients with ITP have abnormal~     bruising and bleeding; severe disease can be life-threatening. For many patients, standard~     drug treatments are not effective, and many of the drugs used may have significant side~     effects with long-term use. Daclizumab is a genetically engineered antibody that suppresses~     the immune system and has been used primarily to prevent rejection in patients who have had~     organ transplants. Daclizumab has fewer side effects than other immune suppressant drugs.~      Patients with ITP 18 years of age or older who have platelet counts less than~     30,000/microliter and have not responded to prednisone treatment may be eligible for this~     study. Candidates will be screened with a medical history, physical examination, and blood~     tests.~      Participants will have a 15-minute infusion of daclizumab every 2 weeks for five doses. They~     will be seen by a physician at least once every 2 weeks while receiving the drug and then at~     weeks 12, 20, and 32 of the study. Blood will be drawn at the 4- and 8-week visits during~     treatment for diagnostic tests, and at each follow-up visit after treatment to assess the~     response to therapy.~      Patients who respond well to treatment will have their pre-study immunosuppressive medicines~     tapered gradually one at a time starting with the 1-month follow-up visit. If their platelet~     count falls to pre-treatment levels at any time during the tapering, the dose reduction will~     stop and pre-study medications will be re-started, if necessary.~   "
270523|NCT00048932|"~     The purpose of this clinical research study is to learn if abatacept is safe when~     co-administered with other approved rheumatoid arthritis medications.~   "
270524|NCT00048854|"~     This study will determine whether characteristics of women with Premenstrual Syndrome~     influence response to treatment with serotonin reuptake inhibitors and whether SRIs can~     alleviate premenstrual symptoms.~   "
270525|NCT00048841|"~     The purpose of this two year study is to examine the safety and effectiveness of alendronate~     (Fosamax) for the prevention of bone loss in men with prostate cancer who are on therapy to~     lower their testosterone levels. All men will receive appropriate calcium and vitamin D~     supplements and one to two years of alendronate therapy. Bone density tests will be done~     every six months.~   "
270526|NCT00048828|"~     This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and~     adolescents who have failed standard antipsychotic treatment for schizophrenia.~   "
270527|NCT00048815|"~     This 6-month study will compare the effectiveness of citalopram (Celexa®), hypericum (St.~     John's Wort), and placebo for the treatment of minor depression.~   "
270528|NCT00048802|"~     This study will compare the effectiveness in the maintenance of continuing adjunctive~     atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the~     maintenance treatment of adolescents with bipolar disorder.~   "
270529|NCT00048581|"~     The purpose of this clinical research study is to determine whether abatacept treatment on a~     background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of~     rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis~     factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF~     therapy in the last 3 months and did not respond. The safety of treatment with abatacept will~     also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months~     after the start of the study.~   "
270530|NCT00048568|"~     Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667)~     in combination with methotrexate is better than methotrexate alone in participants that have~     active rheumatoid arthritis and are not responding to methotrexate. The safety of this~     treatment will also be studied.~      Long Term Extension: The purpose of this amendment is to provide participants who have~     completed the initial 12-month double-blind treatment period the opportunity to receive open~     label treatment with active drug treatment until abatacept is approved in the local country~     or until clinical development has been discontinued.~   "
270531|NCT00048906|"~     This study will determine the safety of the drug Replagal or treating patients with Fabry~     disease, an inherited metabolic disorder. In this disease, an enzyme called~     Alpha-galactosidase A, which normally breaks down a fatty substance called~     globotriaosylceramide (Gb3), is missing or does not function properly. The resulting~     accumulation of Gb3 causes problems with the kidneys, heart, nerves, and blood vessels.~     Replagal is a genetically engineered form of Alpha-galactosidase A. Previous studies have~     shown that patients with Fabry disease who had not progressed to end-stage kidney failure~     tolerated Replagal replacement therapy well. This study will examine the effects of the drug~     in patients with kidney problems associated with Fabry disease.~      Patients with Fabry disease who are on kidney dialysis, or have had a kidney transplant, may~     be eligible for this study.~      During this 6 to 12-month study, participants will receive a 40-minute intravenous (IV)~     infusion of Replagal every other week, with close monitoring during and after the infusions.~     Before the first infusion, patients will be evaluated with a medical history, physical and~     neurological examinations, electrocardiogram (ECG), routine blood and urine tests, kidney~     test, and measurements of height, weight, and vital signs (blood pressure, pulse, breathing~     rate, temperature). In addition, they will have pharmacokinetic studies immediately before~     and following the first infusion of Replagal. For these studies, blood samples of less than a~     teaspoon each will be drawn to measure the level of Replagal enzyme activity. The samples~     will be collected at the following time points: immediately before the infusion; 20 minutes~     into the infusion; at the end of the infusion; after the infusion at 50, 60, and 90 minutes,~     and 2, 3, 4, and 8 hours.~      Safety evaluations will be done once a week for the first month and then once a month for the~     rest of the study period. These evaluations include a physical examination, measurement of~     vital signs, electrocardiogram, routine blood and urine tests, and kidney testing.~   "
270557|NCT00048438|"~     The objective of this study is to determine whether paricalcitol is safe and effective~     compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney~     disease.~   "
270532|NCT00048893|"~     This study will evaluate the effectiveness of chemotherapy and a combination of vaccines to~     treat metastatic breast cancer (breast cancer that has spread beyond the breast) in patients~     whose cancer cells have a protein called carcinoembryonic antigen (CEA) on their surface.~     Patients who require surgery or radiation therapy, or both, will receive these treatments as~     well.~      Patients 18 years of age and older with previously untreated metastatic breast cancer may be~     eligible for this study. Newly diagnosed patients may not have received prior chemotherapy.~     Patients previously diagnosed with local disease may have received chemotherapy or radiation~     therapy at least 18 months before entering the current study. Patients may have received~     hormonal therapy for stage IV disease. Candidates are screened with a medical history and~     physical examination, blood and urine tests, x-rays, heart and lung tests, and a test to~     determine the presence of CEA on their tumor cells.~      Participants undergo the following procedures:~        1. Central venous line: Under local or general anesthesia, an intravenous catheter (plastic~          tube) is inserted into a major vein in the chest. It is used to give chemotherapy and~          other medications and to withdraw blood samples.~        2. Apheresis: Before beginning treatment and at various times before and after~          chemotherapy, patients undergo apheresis to collect white blood cells for later~          re-infusion at the time of immunizations and to evaluate the body's response to the~          vaccines. For this procedure, blood is collected through the central venous catheter and~          circulated through a machine that separates the white cells from the rest of the blood.~          The white cells are removed and frozen for later use. The rest of the blood is returned~          to the patient through the catheter.~        3. First vaccine: Before starting chemotherapy, patients receive one subcutaneous (under~          the skin) injection of a vaccine called rV-CEA-Tricom, along with subcutaneous~          injections of granulocyte macrophage colony stimulating factor (GM-CSF) (Sargramostim),~          a drug that stimulates the bone marrow to release white blood cells and white cell~          precursors into the bloodstream.~        4. Chemotherapy:~             -  Taxol (paclitaxel)/Cytoxan (cyclophosphamide): Patients receive three to five~               cycles of Taxol and Cytoxan. Taxol is given as a continuous 72-hour intravenous~               (intravenous (IV), through a vein) infusion and Cytoxan is given daily for 3 days,~               intravenously, over 1 hour. Cycles are 21 to 42 (usually 28) days. After each~               cycle, patients also receive growth colony stimulating factor (G-CSF) (a drug that~               helps boost white cells.~   "
270533|NCT00048880|"~     Background:~        -  Some cancers, such as Hodgkin's disease, anaplastic large cell lymphoma and others, have~          a protein on the surface of the cancer cell called CD30.~        -  HeFi-1 is an antibody that binds to the CD30 protein and sends signals to the cancer~          cells that can cause them to die.~      Objectives:~        -  To determine the highest dose of HeFi-1 that can safely be given to patients with tumors~          that have the CD30 protein.~        -  To determine the response of the tumor to treatment with HeFi-1.~      Eligibility:~        -  Patients 18 years of age and older with Hodgkin's disease, anaplastic large cell~          lymphoma, cutaneous T cell lymphoma and adult T cell leukemia or lymphoma who have signs~          of tumor growth or recurrence following standard treatment~        -  Patients' tumor cells must have the CD30 protein.~      Design:~        -  Groups of three patients are treated with increasingly higher doses of HeFi-1 (ranging~          from 0.5 to 5 mg/kg) to determine the highest safe dose.~        -  HeFi-1 is infused through a vein on 4 days, followed by 2 days of rest over a 10-day~          period. Patients may receive up to 2 treatment courses if they show some response and do~          not have severe side effects.~        -  Blood samples are collected several times during the study to determine safety. A lymph~          node biopsy is done at the beginning of the study to test the effect of HeFi-1 on cancer~          cells in the test tube, and a bone marrow biopsy may be done at the end of treatment if~          the bone marrow was positive for tumor cells at the beginning of treatment.~   "
270534|NCT00048776|"~     Juvenile secondary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the~     fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud’s~     Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed~     connective tissue disease. When children with secondary Raynaud’s are exposed to chilly or~     cold conditions from weather, cold temperatures, or even holding cold items from the~     refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. The~     investigational drug, Pletal(cilostazol), which has been approved for other conditions,~     inhibits the ability of one type of blood cell, platelets, to form blood clots, and also~     widens narrowed blood vessels. It has been used in a variety of other conditions in which~     blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol)~     to lessen the severity of the symptoms and decrease the number of secondary Raynaud’s~     episodes in juvenile patients.~   "
270535|NCT00048763|"~     Juvenile primary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the~     fingers and sometimes can affect the toes, nose, or ears. When children with primary~     Raynaud’s Phenomenon are exposed to chilly or cold conditions from weather, cold~     temperatures, or even holding cold items from the refrigerator, their fingers may become~     cold, numb, hurt, and/or turn purple or white. Children with primary Raynaud’s Phenomenon~     have no underlying systemic disease. The cause for their symptoms is unknown. The~     investigational drug, Pletal(cilostazol), which has been approved for other conditions,~     inhibits the ability of one type of blood cell, platelets, to form blood clots, and also~     widens narrowed blood vessels. It has been used in a variety of other conditions in which~     blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol)~     to lessen the severity of the symptoms and decrease the number of primary Raynaud’s episodes~     in juvenile patients.~   "
270536|NCT00048789|"~     This study will examine the safety and effectiveness of extracorporeal photopheresis (ECP)~     for treating chronic graft-versus-host disease (GvHD). GvHD is a common complication of stem~     cell transplantation using donated stem cells. It occurs when the donor's T-lymphocytes (a~     type of immune cell) see the patient's cells as foreign and mount an immune response to~     reject them. The attack can cause skin rash, mouth sores, liver or lung inflammation, lack of~     appetite, and muscle stiffness. Chronic GvHD can cause serious illness, and even death, from~     the long-term effects of immune dysfunction and from toxic effects of medications (such as~     cyclosporine and prednisone) used to treat it.~      ECP is an experimental treatment designed to stop the lymphocytes from attacking the body. It~     involves collecting some of the cells that cause GvHD, treating them with a combination of~     drug and light therapy and returning them to the body. Sixty to 80 percent of patients with~     chronic GvHD improve with ECP treatment, and some patients can stop treatment with prednisone~     or cyclosporine, or reduce the drug dosages.~      Patients with chronic GvHD whose condition has not improved after a minimum 14-day course of~     cyclosporine and prednisone may be eligible for this study. Patients must be able to travel~     to the NIH Clinical Center in Bethesda, Maryland, twice a week during the 3-month study~     period.~      Upon entering the study, participants will have a baseline evaluation to measure the extent~     of GvHD. This assessment includes blood tests, eye and dental examinations, skin biopsy for~     patients with skin involvement, and CT scans and lung function tests to look for possible~     lung involvement. Biopsies of the lung, liver, mouth, or eye may be requested if needed to~     confirm GvHD in these tissues. The skin will be photographed before starting ECP treatment~     and once a month during the treatment period. Following baseline tests, participants will~     undergo treatment and evaluations as follows:~      ECP Treatment~      Patients will have blood drawn to collect lymphocytes causing GvHD. This may be done with a~     special needle or catheter (tube inserted into a vein) or for patients who need or prefer it~     with a temporary central venous catheter similar to that used for the stem cell~     transplantation. Patients will have three 2- to 3-hour treatments a week for the first week~     and two treatments a week after that for a total of 25 treatments over 3 months. Patients who~     do not tolerate the treatment...~   "
270537|NCT00048750|"~     The purpose of this study is to determine the efficacy and safety of intravenous micafungin~     versus placebo as prophylactic therapy for invasive fungal infections in patients in the~     intensive care unit considered to be at high risk.~   "
270541|NCT00048698|"~     This study will examine the effects of direct current (DC) electrical polarization of the~     brain on thinking speed, reaction time, mood, and brain waves in healthy individuals. The~     results will provide information for designing further studies to examine the safety and~     effectiveness of this technique in treating certain brain diseases involving impaired~     cognition (thought processing). The study consists of three experiments; participants will~     take part in either one or two of the experiments.~      Healthy right-handed volunteers between 18 and 80 years of age with 12 or more years of~     education may be eligible for this study. Candidates will be screened with a medical and~     educational history and a brief neurological examination. Participants in experiments 2 and 3~     will also be screened with a verbal fluency test in which they will be asked to say as many~     words beginning with certain letters as they can in 1 minute.~      Participants will undergo the following procedures for the experiment(s) in which they~     participate:~      Experiment 1~      While resting quietly, subjects receive 20 minutes of weak electrical current stimulation or~     sham stimulation with no current. For the stimulation, two gauze pads soaked with a~     conducting salt solution are placed on the head-one on the left side and one above the right~     eye. The current is passed between the pads and may cause an itching or tingling sensation~     under the electrodes. Before and after the stimulation, the participant's reaction~     time-tested by moving a finger as fast as possible at the sound of a tone-and mood are~     evaluated. Some participants also have an electroencephalogram, or EEG (brain wave recording)~     during the experiment. After the stimulation, participants take two brief tests of thinking~     speed, and the mood and reaction time tests are repeated.~      Experiment 2~      The participant sits in a chair with electrodes attached to the muscles that control movement~     in a finger on the right hand. Reaction time is tested as described in experiment 1. Then,~     transcranial magnetic stimulation (TMS) is used to test the activity of the brain's motor~     cortex (the part of the brain that controls movement). For TMS, an insulated wire coil is~     placed on the subject's scalp. A brief electrical current is passed through the coil,~     creating a magnetic pulse that travels through the scalp and skull and causes small~     electrical currents in the brain cortex. The stimulation may cause twitching of the right~     hand or arm or produce a mild snapping sensation on the scalp. During the stimulation, the~     electrical activity of muscles in the right hand is recorded on a computer. Following the~     TMS, DC stimulation is applied, as described in experiment 1. The stimulation begins at a low~     level and is followed by repeat TMS and DC stimulation at increasingly higher levels. This~     continues until there is a clear effect on the muscle response to the magnetic pulses, or~     until the stimulation becomes uncomfortable. At the end of the electrical stimulation,~     reaction time is tested again.~      Experiment 3~      This experiment uses the average DC level that produced a change in the size of the responses~     to magnetic stimulation in experiment 2. Thinking speed and reaction time are tested during~     the DC stimulation, and the mood test is given before and during the stimulation. This test~     does not use TMS or EEG recording.~   "
270542|NCT00048685|"~     This study will examine the types of bacteria present in the dental plaque of patients with~     persistent dry mouth. Saliva is essential for digestion and swallowing and for maintaining~     the normal mineralization of teeth. People who suffer from dry mouth usually have a~     significant increase in tooth decay (caries). This study will determine if this increase is~     due solely to reduced salivary flow or also to an increase in certain types of bacteria in~     the mouth.~      Patients participating in the following NIDCR protocols may be eligible for this study:~     Evaluation and Treatment of Salivary Dysfunction (84-D-0056), Natural History of Salivary~     Gland Dysfunction and Sjogren's Syndrome Research Project (99-D-0070), and Salivary~     Evaluation in Normal Volunteers (94-D-0018).~      Participants will have three appointments at the NIH dental clinic as follows:~      Visit 1~      Dental examination and instruction on keeping a detailed diary of food intake.~      Visit 2 (1 week after visit 1)~      Attachment of a bacteria collection device (described below) to the side of a tooth.~      Visit 3 (48 hours after visit 2)~      Removal of the collection device, tooth cleaning and polishing, and submission of food diary.~      The bacteria collection device is a 4mm x 2mm x 2mm square of sterilized tooth obtained from~     slicing an extracted healthy tooth donated by another patient. The donated teeth are either~     extracted impacted third molars (wisdom teeth) or teeth extracted for teeth straightening~     (orthodontics). The device is heat-sterilized before being bonded to the participant's tooth.~     The dental cement used for bonding can be removed after 48 hours with no damage to the~     surface of the participant's tooth.~   "
270543|NCT00048672|"~     The goal of this clinical research study is to see if imatinib mesylate (Gleevec, STI571) can~     improve CML in chronic phase.~      Objectives:~      Primary Objective:~      To increase the proportion of patients achieving a complete cytogenetic response in patients~     with Ph-positive early chronic phase CML using initial Gleevec therapy.~      Secondary Objective:~      To evaluate the duration of cytogenetic response, duration of hematologic response and~     survival.~   "
270544|NCT00048659|"~     The purpose of this study is to determine if patients who take YM598 in addition to~     mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated~     with prostate cancer metastases in the bone.~   "
270545|NCT00048646|"~     The purpose of this study is to determine if progesterone treatment safely reduces brain~     swelling and damage after injury.~   "
270546|NCT00048633|"~     The primary objective of this phase II study is to assess if XR9576, a selective MDR-1~     inhibitor, is able to reverse primary doxorubicin or taxane resistance in advanced breast~     cancer. Clinical activity will be measured by objective tumor response rates observed after~     treatment with XR9576 in combination with taxane or anthracycline containing chemotherapy in~     patients previously resistant to the same agent(s).~      The secondary objectives of the study are to assess the biological activity of XR9576 and~     evaluate MDR-1 expression in these tumors. The MDR-1 inhibitory activity of XR9576 will be~     evaluated by serial sestamibi scans of the tumor. MDR-1 expression will be detected by~     immunohistochemistry.~   "
270547|NCT00048620|"~     The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of two dose~     levels of weekly intravenous infusions of recombinant human N-acetylgalactosamine 4-sulfatase~     (rhASB) for a minimum of 24 weeks in patients diagnosed with MPS VI.~   "
270548|NCT00048607|"~     A clinical study to determine the efficacy and safety of MK0869 in the treatment of~     depression~   "
270549|NCT00048594|"~     A clinical study to determine the efficacy and safety of an investigational medication~     (MK0869) in the treatment of depression.~   "
270550|NCT00048555|"~     To determine what side effects and what clinical effect, if any, the administration of this~     investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is~     approved by the United States Food and Drug Administration (FDA) to treat patients with~     relapsed or refractory follicular NHL], has in this patient population.~   "
270551|NCT00048542|"~     This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate~     adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis~     (JIA) who are either methotrexate (MTX) treated or non-MTX treated.~   "
270552|NCT00048529|"~     This is a clinical research study of T900607-sodium to determine if it is effective and safe~     in treating gastric cancer and adenocarcinoma of the esophagus. Patients will be treated on a~     weekly basis with an intravenous injection of the study drug.~   "
270553|NCT00048516|"~     The objective of this study is to determine whether paricalcitol is safe and effective~     compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney~     disease.~   "
270554|NCT00048503|"~     The purpose of this study is to determine if giving tipifarnib after standard treatment will~     prevent leukemia from coming back (relapsing). Tipifarnib belongs to a class of drugs called~     Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.~   "
270559|NCT00048490|"~     This study will use transcranial magnetic stimulation, or TMS (described below), to treat~     epilepsy in certain patients whose seizures persist despite optimum medical treatment. TMS~     used in this study is intended to lessen the number of seizures a patient has by decreasing~     excitability of the brain in the region where the seizures originate.~      Patients between 5 and 65 years of age who have had epilepsy for two or more years and have~     had at least one seizure a week for at least 6 months may be eligible for this 18-week study.~     Their seizures must come from a neocortical focus-that is, near the surface of the brain.~     Candidates will be selected from the NIH Epilepsy clinic and will be screened with an~     electroencephalogram (EEG), magnetic resonance imaging (MRI) scans, and blood tests.~      Participants will keep a diary of the seizures they experience over an 8-week period. After~     the 8 weeks, they will come to the NIH outpatient clinic for 6 consecutive days for the~     following procedures:~        -  Day 1: A regular clinic visit, plus 6 hours of video-EEG recording (described below)~        -  Days 2 through 5: Video-EEG monitoring and TMS as follows:~      8:00 - 11: 00 a.m. 3 hours video-EEG monitoring~      11:00 - 12:30 p.m. TMS (includes set-up time; actual stimulation time lasts 30 minutes)~      12:30 - 3:00 p.m. Lunch + rest~      3:00 - 4:30 p.m. TMS~      4:30 - 7:30 p.m. 3 hours video-EEG monitoring~      (On the fifth day, subjects will have 6 hours of video-EEG monitoring in the afternoon~     instead of 3 hours.)~      Participants will be randomly assigned to one of two TMS groups. One group will have TMS~     delivered in a way that is thought to have a chance of reducing seizures; the other will have~     sham, or placebo, stimulation.~      When the TMS sessions are completed, participants will keep a diary of their seizures for~     another 8 weeks.~      Transcranial Magnetic Stimulation~      For TMS, an insulated wire coil is placed on the subject's scalp. A brief electrical current~     passes through the coil, creating a magnetic pulse that travels through the scalp and skull~     and causes small electrical currents in the cortex, or outer part of the brain. The~     stimulation may cause muscle, hand or arm twitching, or may cause twitches or temporary~     tingling in the forearm, head, or face muscles. During the stimulation, electrical activity~     of muscles is recorded with a computer or other recording device, using electrodes attached~     to the skin with tape. Some TMS sessions may be videotaped.~      Video-EEG Recordings~      The EEG recording device is housed in a small pouchlike container that is worn below the~     shoulder, attached to a belt worn around the waist.~   "
270560|NCT00048477|"~     Nitric oxide gas is important in regulating blood vessel dilation, and consequently, blood~     flow. This gas is continuously produced by endothelial cells, which line the blood vessels.~     This study will examine whether nitrite, a molecule that normally circulates in the blood~     stream, can also dilate blood vessels. The results of this study may be valuable in~     developing treatments for people with conditions associated with impaired endothelial~     production of nitric oxide, including high blood pressure, high blood cholesterol, diabetes,~     estrogen deficiency, and others.~      Healthy, non-smoking normal volunteers 21 years of age or older may be eligible for this~     study. People who lack the enzyme G6PD or cytochrome B5 in their red blood cells may not~     participate. Absence of these enzymes can lead to episodes of sudden shortness of breath and~     cyanosis (blueness of the skin due to lack of sufficient oxygen). Participants will undergo~     the procedures described in study Parts A and B, as follows:~        -  Part A - After numbing the skin, small tubes are placed in the artery and vein at the~          inside of the elbow of the dominant arm (right- or left-handed) and a small tube is~          placed in a vein of the other arm. The tubes are used for infusing saline (salt water)~          and for drawing blood samples. A pressure cuff is placed around the upper part of the~          dominant arm, and a rubber band device called a strain gauge is also placed around the~          arm to measure blood flow. When the cuff is inflated, blood flows into the arm,~          stretching the strain gauge at a rate proportional to the flow. Grip-strength of the~          dominant arm is measured with a dynamometer to determine maximum grip-strength. Then,~          several measurements of blood flow, nitrite, hemoglobin, and handgrip are made before~          and after administration of L-NMMA, a drug that blocks endothelial production of nitric~          oxide.~        -  Part B - Part A testing is repeated, except that sodium nitrite dissolved in a saline~          solution is infused into the artery of the forearm for a few minutes before and during~          the hand-grip exercises. In addition, blood samples are drawn before and after each~          handgrip exercise to measure methemoglobin, a substance that, at excessive levels, can~          cause adverse side effects.~   "
270561|NCT00048412|"~     1. To assess the treatment related mortality of allogeneic stem cell transplantation with~          non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients~          with hematological diseases and renal cell carcinoma not eligible for conventional~          (myeloablative) therapy.~        2. To assess the time to engraftment and incidence of graft failure in patients receiving~          this transplant regimen.~        3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used~          as part of a subablative conditioning regimen.~   "
270562|NCT00048399|"~     To assess the safety, feasibility, and rate of donor engraftment for patients with primary or~     secondary engraftment failure after treatment with fludarabine and CAMPATH 1H used as a~     preparative regimen for HLA-identical sibling blood stem cell transplantation (SCT).~      To assess the safety, feasibility, and rate of donor engraftment for patients with primary or~     secondary engraftment failure after treatment with fludarabine and CAMPATH 1H as a~     preparative regimen for matched unrelated or single antigen mismatched family donor marrow~     transplantation.~   "
270563|NCT00048386|"~     PRIMARY OBJECTIVE To determine the percentage of patients with high risk neuroblastoma in~     first or subsequent partial response or better, or with microscopic residual bone marrow~     disease, who demonstrate an immunological anti-tumor response at any time during, and for up~     to 12 months from initiation of, treatment with subcutaneous injections of autologous~     neuroblastoma cells, genetically modified by adenoviral vectors to secrete interleukin-2~     (IL-2) (autologous neuroblastoma vaccine)~      SECONDARY OBJECTIVES 1. To determine the toxicity of the autologous neuroblastoma vaccine~     given according to this schedule 2. To obtain preliminary data on the effect of vaccine~     administration on progression-free survival from high-risk neuroblastoma~   "
270564|NCT00048373|"~     The purpose of this study is to learn about the response of Langerhans cell histiocytosis~     (LCH) to Enbrel in patients who have failed to respond to standard therapies. We are also~     looking specifically at what side effects Enbrel has on patients. We expect to enroll 20~     patients on this study and anticipate the subjects active participation to last up to one~     year.~   "
270565|NCT00048360|"~     This is a placebo controlled study evaluating the efficacy and safety of medication in adults~     with Attention-Deficit Hyperactivity Disorder (ADHD).~   "
270566|NCT00048321|"~     ISIS 104838 is an antisense oligonucleotide drug that reduces the production of a specific~     protein called tumor necrosis factor (TNF-alpha), a substance that contributes to joint pain~     and swelling in rheumatoid arthritis. ISIS 104838 works by blocking TNF-alpha messenger RNA,~     the instruction molecule that is required for the production of TNF-alpha protein. This~     trial will assess the safety and efficacy of ISIS 1048383 by subcutaneous injection,~     administered by 3 different dosing regimens for 3 months, versus placebo. Approximately 160~     TNF-alpha inhibitor-naïve rheumatoid arthritis patients will be evaluated at 32 sites in the~     U.S. and Canada.~   "
270567|NCT00048308|"~     During a heart bypass procedure, a substance called complement is released by the body.~     This complement causes inflammation, which can lead to side effects such as chest pain, heart~     attacks, heart failure, or impairment of memory, language and motor skills. The purpose of~     this study is to find out if the study drug (pexelizumab), which blocks complement release,~     can reduce such side effects and be taken safely.~   "
270583|NCT00048074|"~     This study will assess the efficacy and safety of intravenous administration of Bonviva~     regimens in women with post-menopausal osteoporosis, compared to oral daily administration.~     Patients will also receive daily supplementation with vitamin D and calcium. The anticipated~     time of study treatment is 2+ years, and the target sample size is 500+ individuals.~   "
270568|NCT00048347|"~     This study will evaluate the safety and effectiveness of the drug interferon-beta1a (AVONEX)~     in treating ulcerative colitis and examine the drug's effect on the immune system. People~     with ulcerative colitis have increased amounts of inflammatory chemicals (cytokines) made by~     immune cells in the lining of the colon. Studies have shown that interferon-beta may block~     the activity of these cytokines. Interferon-beta1a (AVONEX) is currently FDA-approved to~     treat multiple sclerosis, a disease involving inflammation of the brain and spinal cord.~      Patients 18 years of age and older who have had ulcerative colitis for at least 4 months may~     be eligible for this study. Candidates will be screened with a review of their medical~     records, a medical history and physical examination, electrocardiogram (EKG), blood, urine,~     and stool tests, and a pregnancy test for women of childbearing potential. A colonoscopy will~     also be done to determine disease activity and extent. This test uses a lighted tube to~     examine the amount of inflammation in the colon and take tissue samples (biopsies) for~     testing. Before the test, the patient is given a medicine to allay anxiety and the discomfort~     of inserting the endoscope into the rectum. This flexible tube allows the doctor to see the~     intestinal mucosa and project an image of the inner lining of the intestine onto a TV~     monitor. At various places in the intestine, small pieces of tissue are plucked out by a~     special device at the tip of the endoscope. The procedure generally lasts 30 minutes to 1~     hour.~      Participants will come to the NIH Clinical Center once a week for 4 weeks to receive an~     injection of interferon-beta, fill out questionnaires, and have a symptoms check, physical~     examination, and blood tests. Patients whose colitis has not worsened at the end of the 4~     weeks and who have not had significant drug side effects will continue to receive weekly~     injections for an additional 8 weeks. Some patients may receive some of the last eight~     injections outside of NIH, but all patients will visit the Clinical Center visits every 3 to~     4 weeks for a physical exam, symptoms check and blood tests.~      After the 12 injections are completed, patients will have another colonoscopy to evaluate the~     response to treatment and will return to the Clinical Center every 6 weeks for a total of~     four visits, for a physical examination, symptoms check and blood tests.~   "
270569|NCT00048334|"~     This phase I study will evaluate the experimental drug Romidepsinin patients with advanced~     cancer. The study will: 1) determine how well patients tolerate Romidepsin; 2) measure blood~     levels of Romidepsin during treatment; 3) analyze the cellular and molecular effects of the~     drug; and 4) determine if Romidepsin can shrink tumors. Romidepsin has been shown to kill~     cancer cells growing in the laboratory and to shrink tumors in animals with various tumor~     types. In preliminary studies, several patients with a type of lymphoma and one patient with~     kidney cancer responded to treatment.~      Patients 18 years of age and older with advanced cancer (excluding acute leukemia) may be~     eligible for this study. Candidates are screened with a medical history and physical~     examination, x-rays and CT scans, and blood and urine tests. Patients with thyroid cancer may~     also have magnetic resonance imaging (MRI). This test uses a magnetic field instead of x-rays~     to obtain images or body organs and tissues.~      Participants receive three infusions of Romidepsin administered through an intravenous line~     over 4 hours on days 1, 3 and 5 of a 21-day treatment cycle. The intravenous line is a~     catheter (plastic tube) placed in a vein and may be a peripheral line, inserted in a vein in~     the arm, or a central line, in which the tube is placed under the skin of the chest or neck~     into a major vein. Patients are hospitalized for the first 6 days of the first cycle to~     monitor heart rate. Those who tolerate the treatment well may continue as an outpatient.~      In addition to drug therapy, participants undergo the following procedures:~        -  Blood tests: Small amounts of blood are drawn frequently during the first five days of~          treatment to measure Romidepsin levels and to see how the body uses and excretes the~          drug. A heparin lock (an indwelling device to keep the vein open) may be put in the vein~          to prevent the need for repeated needle sticks.~        -  Biopsies (removal of a small sample of tumor tissue): Tumors that are accessible may be~          biopsied at the start of the study and at different times during treatment. Biopsies are~          done no more than three times per cycle, and no more than nine biopsies are done within~          a year. The samples are examined for the effects of Romidepsin on proteins that control~          the way cells divide and stay alive.~        -  Apheresis: This procedure is done to collect white blood cells and cancer cells for~          research. Blood is collected through a needle in an arm vein and directed into a machine~          that separates it into its components by centrifugation (spinning). The white cells are~          removed and the red cells are returned to the patient through the same needle or through~          another needle in the other arm.~        -  Scans and x-rays: Imaging studies are usually done before starting treatment. Some of~          them are repeated at every 2 cycles (6 weeks), and some at the end of the patient's~          participation in the study. The tests may include chest x-rays, plain x-rays of affected~          bones, CT scans of the chest, abdomen, and pelvis, bone scans, and a MUGA scan (special~          X-ray of the heart) or echocardiogram (ultrasound of the heart) to test heart function~          before and during the study. MRI or positron emission tomography (PET) scans may also be~          done to detect tumors. PET scans use a small amount of a radioactive substance injected~          into a vein. The radioactivity is detected by a special camera during scanning to detect~          cancer cells.~        -  Other tests include an electrocardiogram (recording of the electrical activity of the~          heart) before and after each dose of depsipeptide. Eye exams are done if there are~          vision changes or if the doctor recommends an eye test.~   "
270570|NCT00048295|"~     ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific~     protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant~     role in the increase of inflammation. People with Crohn’s disease have been shown to~     over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA,~     the “instruction” molecule that is required for the production of ICAM-1 protein. This trial~     will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week~     period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or~     immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.~   "
270571|NCT00048282|"~     The purpose of this study is to provide researchers with information that will help them~     prepare for a future study to test the efficacy of two anti-HIV vaginal gels. This study will~     also estimate how likely people living in certain areas are to become infected with HIV and~     other infections passed during sex.~   "
270572|NCT00048230|"~     This study will compare the efficacy of PS-341 versus high dose dexamethasone.~   "
270573|NCT00048217|"~     Patients who complete study T1249-102 (must be currently failing a T-20 containing regimen to~     participate in this study) will receive T-1249 at a dose of 200mg daily in combination with a~     background antiretroviral regimen for 96 weeks. Only patients that participated in study~     T1249-102 can participate in study T1249-105.~   "
270574|NCT00048204|"~     A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With~     Major Depressive Disorder (MDD)~   "
270575|NCT00048256|"~     This study will look at how people cope with an upcoming bone marrow transplant and how~     personality characteristics influence coping styles in stressful medical situations.~     Personality traits, such as extraversion, optimism and self-esteem have been related to~     active, problem-focused coping styles, whereas neuroticism has been related to increased~     psychological distress and denial as a way of coping. Coping styles, in turn, have been~     related to disease outcome. For example, a fighting spirit and avoidance have been correlated~     with longer survival, whereas fatalism, anxious preoccupation and feelings of helplessness~     and hopelessness were related to a poor disease outcome. A better understanding of the~     relationship between coping styles and personality may help improve supportive care for~     people undergoing bone marrow transplants. This study will:~        -  Explore the relationship between personality traits, coping styles and psychological~          stress in patients awaiting bone marrow transplantation~        -  Identify what coping styles people use to prepare for bone marrow transplantation~        -  Identify what personality traits are related to particular coping styles in patients~          awaiting bone marrow transplantation~        -  Identify the relationship between personality factors and level of psychological~          distress in patients awaiting bone marrow transplantation~      Cancer patients 18 years of age and older who are scheduled for bone marrow transplant are~     eligible for this study.~      Participants will fill out pencil-and-paper questionnaires providing demographic information~     (such as age, gender, marital status, ethnicity, and so forth) and answering questions about~     their opinions and preferences. The information will be used to assess the participants'~     personality characteristics, coping styles, and psychological distress. The questionnaires~     take about 45 to 50 minutes to complete.~   "
270576|NCT00048165|"~     The purpose of the study is to compare the number of randomized participants in each~     treatment group who experience an acute rejection episode in the first 6 months after~     undergoing cardiac transplantation.~   "
270577|NCT00048152|"~     This study will compare kidney function in kidney transplant patients following treatment~     with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine).~     The anticipated time on study treatment is 6-12 months, and the target sample size is 500+~     individuals.~   "
270578|NCT00048139|"~     This study will assess the efficacy and safety of intermittent oral Xeloda administration in~     combination with irinotecan as a first-line treatment in patients with advanced and/or~     metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the~     target sample size is <100 individuals.~   "
270579|NCT00048126|"~     This study will assess the efficacy and safety of continuous oral Xeloda administration in~     combination with intravenous irinotecan as a first-line treatment in patients with advanced~     and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months~     and the target sample size is <100 individuals.~   "
270580|NCT00048113|"~     ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific~     protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant~     role in the increase of inflammation. People with Crohn's disease have been shown to~     over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA,~     the instruction molecule that is required for the production of ICAM-1 protein. This trial~     will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week~     period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or~     immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.~   "
270581|NCT00048100|"~     Objectives:~        1. Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute~          leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell~          transplants.~        2. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in~          patients after infusion.~        3. Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in~          Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting~          and sustaining remission in patients with relapse after allo-BMT or stem cell~          transplant.~   "
270700|NCT00044824|"~     The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID~     compared to placebo in the treatment of subjects with mild to moderate persistent asthma~   "
270586|NCT00048035|"~     This study will determine the appropriate dose and frequency of administration of iv Mircera~     maintenance therapy in hemodialysis patients with chronic renal anemia who were previously~     receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target~     sample size is <100 individuals.~   "
270587|NCT00048022|"~     The primary objective of the study is to evaluate the anti-inflammatory action and safety of~     Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The~     research is being conducted at up to 40 clinical research sites in the US. Study participants~     will have a number of visits to a research site over a 4-month period.~   "
270588|NCT00048009|"~     The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to~     be used in future studies, assess the efficacy and safety, and the anti-inflammatory action~     of the test drug in the treatment of asthmatic patients who are not currently receiving~     chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical~     research sites in the US, Mexico, and Canada. Study participants will have a number of visits~     to a research site over approximately a 4-month period.~   "
270589|NCT00047983|"~     The purpose of this study is to evaluate the effectiveness of nutritional supplements in~     increasing the amount of omega-3 fatty acids (and arginine) in the red blood cell membranes~     and plasma of kidney transplant patients, and, secondarily, to compare patient compliance.~     The long-term goal of this study is to develop low risk therapies that will allow improved~     and lasting survival of donor tissue with minimal suppression of the immune system.~   "
270590|NCT00047970|"~     The Sister Study is prospectively examining environmental and familial risk factors for~     breast cancer and other diseases in a cohort of 50,884 sisters of women who have had breast~     cancer. Such sisters have about twice the risk of developing breast cancer as other women.~   "
270591|NCT00047840|"~     The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with~     NSCLC after Failure of Prior Platinum-based Chemotherapy.~   "
270592|NCT00047827|"~     The purpose of this study is to evaluate the safety and effectiveness of micafungin in~     combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.~   "
270593|NCT00047814|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4~     weeks therapy with FK788 in subjects with chronic hepatitis C virus (HCV) infection. Also, to~     assess the effect of FK788 on serum ALT concentration and hepatitis C viral level during~     therapy and for four weeks following therapy.~   "
270594|NCT00047957|"~     This study will use transcranial magnetic stimulation, or TMS (described below), to examine~     how the brain controls muscle movement to prevent unwanted movements in surrounding muscles.~     For example, when a person moves a finger, a part of the brain called the cortex prevents~     unwanted movements in other fingers by a process called cortical inhibition. In people with~     the muscle disorder dystonia, cortical inhibition does not work properly and patients suffer~     from uncontrolled and sometimes painful movements. A better understanding of how this process~     works in normal people may shed light on what goes wrong in dystonia and how the condition~     can be treated.~      Healthy normal volunteers 19 years of age and older may be eligible for this study.~     Candidates will be screened with a medical history and physical and neurological~     examinations. People with a current medical or surgical condition or neurological or~     psychiatric illness may not participate, nor may individuals who are taking medication that~     may influence nervous system function.~      Participants will undergo TMS to record the electrical activity of muscles in the hand and~     arm that are activated by magnetic stimulation. For the procedure, subjects are seated in a~     chair with their hands placed on a pillow in their laps. A wire coil in placed on their~     scalps. A brief electrical current is passed through the coil, creating a magnetic pulse that~     stimulates the brain. Subjects will be asked to move their second finger in response to a~     loud beep or visual cue. In some trials, a brief, mild electrical shock will also be applied~     to the end of either the second or fifth finger. The shock is not painful.~      TMS may cause muscle, hand or arm twitching if the coil is near the part of the brain that~     controls movement, or it may induce twitches or temporary tingling in the forearm, head, or~     face muscles. The twitching may cause mild discomfort, but the procedure is rarely considered~     painful.~   "
270595|NCT00047944|"~     Anxiety in children of parents with major depressive disorder (MDD) poses a particularly high~     risk for later-life MDD. In adults, MDD involves dysfunction in prefrontal brain regions that~     regulate attention to emotional stimuli. These abnormalities: i) have been found primarily in~     adults with specific familial forms of MDD; ii) persist after recovery from MDD, and iii)~     relate to anxiety. These findings raise the possibility that risk for MDD is tied to~     dysfunction in prefrontal regions involved in regulation of emotion, which possibly manifests~     as early-life anxiety. If this possibility were confirmed in never-depressed adolescents at~     high risk for MDD, the findings would provide key insights into the developmental~     neurobiology of MDD. The goal of this protocol is to study the neural substrate of risk for~     MDD in young people. This protocol tests the hypothesis that adolescents at high risk for MDD~     by virtue of childhood anxiety and parental history of MDD exhibit dysfunction in prefrontal~     cortex and amygdala, regions involved in emotion regulation. This goal will be accomplished~     through fMRI studies of emotion regulation in high and low-risk adolescents.~      For this research, at-risk adolescents will be recruited from participants in an NIMH-funded~     extramural study at New York University (NYU) examining the biology of risk for anxiety and~     depressive disorders. Over a three-year period, 45 high-risk probands and 60 low-risk~     comparisons will be studied, including 20 comparisons from the NYU sample and 40 from the~     Washington DC metropolitan area. In the present protocol, to be conducted at NIH, subjects~     will undergo volumetric MRI scans to assess structural abnormalities in the prefrontal cortex~     and medial temporal lobe. They will complete a series of four out-of-scanner cognitive tasks~     and two fMRI-based cognitive tasks that measure modulation of attention to emotional stimuli.~     The fMRI tasks are hypothesized to differentially engage the prefrontal cortex and amygdala~     in low vs. high risk subjects. These tasks will be used to test the hypothesis that at-risk~     individuals exhibit enhanced amygdala and reduced prefrontal activation on the fMRI~     emotion/attention tasks.~   "
270596|NCT00047931|"~     This study will test the safety of an experimental vaccine against HIV and examine whether it~     induces an immune response to HIV. A vaccine is a substance given to try to create resistance~     or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic~     material) of four HIV proteins called 'gag', 'pol', 'Nef', and 'Env'. Injected into a human,~     the viral DNA instructs the body to make small amounts of some HIV proteins. This study will~     see if the body then creates an immune response to these proteins. Study participants cannot~     catch HIV or AIDS from the DNA vaccine or any proteins made from it.~      Healthy normal volunteers between 18 and 40 years of age may be eligible for this study.~     Candidates will be screened with a medical history, physical examination and blood and urine~     tests. Women will also have a pregnancy test. Women enrolled in the study must either be~     infertile (e.g., due to menopause or hysterectomy) or must agree either to abstain from~     heterosexual sex or to practice birth control for at least 21 days before beginning the study~     and throughout its duration.~      Participants will be randomly assigned to receive either the experimental vaccine or a~     placebo (a salt solution that does not contain any active substance) and will be divided into~     three groups, based on their entry into the study. Of the first seven people enrolled (Group~     1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is~     safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two~     will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an~     8-mg dose of vaccine and six will receive placebo.~      All participants will receive three injections in an upper arm muscle-one injection a month~     for three months-with a needle-less device called a Biojector 2000® (Registered Trademark).~     At the time of each injection, participants will be observed for at least 1 hour after~     immunization. At home, they will record their temperature and any symptoms they may~     experience, including any effects at the injection site, for at least 7 days, or as long as~     the symptoms remain. If symptoms occur, participants will report them immediately to the~     clinic staff and, if necessary, come to the clinic for an examination.~      Participants will have about 10 clinic visits during the study. Most visits will last about 2~     hours; those on vaccination days will last about 4 hours. ...~   "
270701|NCT00044811|"~     The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID~     compared to placebo in the treatment of subjects with mild to moderate persistent asthma~   "
270597|NCT00047918|"~     This study will 1) identify characteristics of bone marrow mast cells in patients with~     unexplained anaphylaxis and flushing or with mastocytosis and 2) determine whether~     mastocytosis might be the underlying cause of unexplained anaphylaxis in some patients with~     this condition. Anaphylaxis is a hypersensitivity reaction in which patients may have~     flushing, hives, stuffy nose, red itchy eyes, difficulty breathing, swelling of the tongue,~     throat, palms and soles, abdominal cramping, lightheadedness, decreased blood pressure, and~     loss of consciousness. Although allergens are a common cause of anaphylactic episodes, no~     cause can be identified in up to 50 percent of patients who have recurrent events.~     Mastocytosis is a disease of excessive mast cells in tissues such as skin and bone marrow.~     These cells can release chemicals that result in itching, blisters, flushing, bone pain, and~     abdominal pain.~      Patients 18 years of age and older who have episodes of anaphylaxis or flushing with no~     apparent cause or who have mastocytosis may be eligible for this study. Participants will~     have a medical history and physical examination; blood tests to identify genetic changes that~     are important in the growth, development, and functioning of human mast cells; and bone~     marrow aspiration and biopsy. For the bone marrow procedure, the skin over the hipbone and~     the outer surface of the bone itself are numbed with local anesthesia. Then, a special needle~     is inserted into the hipbone and about 1 tablespoon of bone marrow is drawn into a syringe.~     Another needle is inserted into the same area to collect a small piece of the bone marrow.~     Additional procedures may include allergen testing, urinalysis, and 24-hour urine collection.~      Participants will return to NIH for reassessment of disease status in 12 to 18 months. The~     follow-up evaluation will include a history and physical examination, blood tests, possible~     repeat bone marrow and aspiration in patients whose clinical signs or symptoms change~     significantly, and other tests as clinically indicated.~      First-degree relatives (parents, children, siblings) may be enrolled in limited instances to~     provide a blood sample for genetic analysis related to mast cell development and function for~     comparison with that of patients when they have similar symptoms.~   "
270598|NCT00047905|"~     This study will examine the process of prenatal genetic counseling to determine how various~     client and counselor factors affect the communication process in a counseling session. The~     specific aims of the study are to:~        -  Provide information on prenatal genetic counselors' interactions with clients for the~          basis of a future larger study of the genetic counseling process.~        -  Determine the average length and the range of length of prenatal genetic counselors'~          interactions with clients when family history information has already been provided.~        -  Document on videotape the communication content and interaction dynamics of prenatal~          genetic counselors interacting with clients in order to:~        -  Characterize different models of prenatal genetic counseling~        -  Determine the nature of discussions concerning cystic fibrosis carrier testing within~          the context of prenatal genetic counseling.~        -  Examine the impact of prenatal genetic counselors' characteristics (years of experience,~          training and background, age, clinical setting, anxiety) on the communication content~          and interaction dynamics of sessions with clients.~        -  Examine the impact of the presence of a spouse on the communication content and~          interaction dynamics of prenatal genetic counseling sessions with clients.~        -  Examine the impact of client verbal emotional cues on the communication content and~          interaction dynamics of prenatal genetic counseling sessions.~      Counselors will be recruited for this study from among practicing prenatal genetic counselors~     at regional meetings and a national meeting of the National Society of Genetic Counselors.~     They will perform prenatal genetic counseling sessions with actors in the roles of client and~     client's spouse. The sessions will be videotaped, and the counselor and actors will fill out~     questionnaires regarding the characteristics of the counselor and the session.~      Counselors may be contacted later to request permission to use segments of their videotaped~     sessions for creating a video teaching tool for counseling professionals that illustrates~     different ways to practice the genetic counseling.~   "
270599|NCT00047879|"~     This study will examine the safety and effectiveness of peginterferon alpha-2b (PEG-Intron)~     alone and together with thalidomide in patients with gliomas (a type of brain tumor). Gliomas~     are nourished by blood delivered through blood vessels whose formation is stimulated by~     substances produced by the tumor itself. Stopping the growth of new vessels can slow or~     prevent tumor growth. The Food and Drug Administration has approved various interferons for~     treating several diseases, including melanoma and some leukemias. These drugs block new~     vessel growth in patients with recurrent tumors, but in high doses they produce serious side~     effects. Therefore, this study will use a low dose of PEG-Intron given weekly instead of high~     doses given several times a week. Thalidomide, currently approved to treat leprosy, also~     blocks development of new blood vessel formation. In a recent study of thalidomide given to~     36 patients with gliomas, 4 patients had tumor shrinkage, 12 had stable disease for at least~     2 months, and at least 3 had responses to treatment lasting 6 to 14 months.~      Patients 18 years of age and older with a primary glioma whose tumor has recurred or is~     growing following standard treatment and does not respond to radiation therapy may be~     eligible for this study. Candidates will be screened with a physical examination, blood and~     urine tests (including a pregnancy test for women of childbearing potential), and magnetic~     resonance imaging (MRI) or computed tomography (CT) of the head.~      Patients will continue treatment cycles as long as the drug is tolerated without serious side~     effects and the tumor is not growing. While on the study, patients will undergo various tests~     and procedures as follows:~      Physical and neurologic examinations every 6 weeks MRI or CT brain scan every 6 weeks to~     assess tumor status. MRI is a diagnostic test that uses a strong magnetic field and radio~     waves to show structural and chemical changes in tissues. During the scan, the patient lies~     on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff~     member through an intercom system at all times during the procedure.~   "
270600|NCT00047866|"~     This study seeks more information about the biology of substance dependency by exploring the~     brain areas involved in feeling positive and negative emotions. Specifically, it will~     determine whether a brain chemical called dopamine affects activity in certain brain regions~     during performance of a game that involves winning and losing money. Brain activity will be~     examined using magnetic resonance imaging (MRI), a test that uses a magnetic field and radio~     waves to produce images of brain structure and function.~      Young to middle-aged healthy adults may participate in this study. Candidates will be~     screened with a medical history, physical examination, electrocardiogram (EKG), psychiatric~     interview, and blood and urine tests. Participants will be assigned to one of the two study~     procedures, as follows:~      Tyrosine/Phenylalanine~      This study requires two overnight stays at the NIH Clinical Center. For each stay, subjects~     are admitted to the hospital the afternoon before the MRI scan. From the time of admission~     until after the scan, their diets are restricted to food relatively low in amino acids,~     prepared by NIH dietitians. The next day, participants undergo MRI scanning. For this~     procedure, the subject lies on a table that is moved into the scanner, a metal cylindrical~     machine. Earplugs are worn to muffle loud noises that occur with electrical switching of the~     radio frequency circuits. Imaging of brain structure takes about 10 to 15 minutes. Additional~     scans are then taken to measure brain activity while the subject plays simple computer games~     for money. These scans take about another 20 to 45 minutes. Five hours before the MRI, the~     subject drinks one of two beverages containing amino acids. A different beverage is given for~     each of the two visits: one drink lacks the essential amino acids tyrosine and phenylalanine,~     from which the body makes dopamine; the other contains balanced amounts of these two amino~     acids. Finally, subjects fill out mood-rating questionnaires before and after drinking each~     of the beverages.~      Dextroamphetamine~      This study requires two outpatient visits to the NIH Clinical Center. For one visit,~     participants are given an injection of 0.2 mg/kg body weight of the drug dextroamphetamine;~     for the other, they are given an injection of saline (salt water). After each injection, they~     undergo MRI scanning while playing computer games for money, as described above. They will~     fill out mood-rating questionnaires before and after each brain scan.~   "
270601|NCT00047853|"~     The purpose of this study is to use brain imaging technology to investigate brain changes in~     people exposed to predictable versus unpredictable unpleasant stimuli. Unpleasant events that~     can be predicted evoke a response of fear, whereas unpredictable, unpleasant stimuli cause~     chronic anxiety not associated with a specific event. Information gained from this study may~     help in the development of more effective treatments for anxiety disorders.~      When confronted with fearful events, people eventually develop fear of specific cues that~     were associated with these events as well as to the environmental context in which the~     fearful event occurred. Evidence suggests that cued fear and contextual fear model different~     aspects of anxiety. However, studies that examine the way the brain affects expression of~     contextual fear have not been conducted. This study will use magnetic resonance imaging (MRI)~     or Magneto-encephalography (MEG) to compare the brain activity underlying fear brought on by~     predictable and unpredictable aversive stimuli.~   "
270602|NCT00047801|"~     The purpose of this study is to determine the effectiveness and safety of TLK286 given~     intravenously once every three weeks in combination with docetaxel (Taxotere) in the~     treatment of patients with non-small cell lung cancer that is resistant to platinum-based~     chemotherapy.~   "
270603|NCT00047788|"~     The primary objective is to assess the efficacy of ZD6474 when given orally to patients with~     relapsed multiple myeloma. A minimum of 15 and a maximum of 30 evaluable patients will be~     entered on study~   "
270604|NCT00047775|"~     A placebo-controlled trial of BiDil added to standard therapy in African-American patients~     with heart failure.~   "
270605|NCT00047762|"~     The purpose of this study is test the safety of Tarceva, find the best dose, and see what~     effects (good and bad) it has on you and your colorectal cancer. The effects of Tarceva will~     be evaluated in combination with 5-fluorouracil, leucovorin, and irinotecan, with or without~     Bevacizumab.~   "
270606|NCT00047554|"~     The purpose of this study was to monitor iris pigmentation changes over a 5-year period in~     patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these~     individuals must have experienced an iris pigmentation change while previously dosing with~     TRAVATAN.~   "
270607|NCT00047541|"~     To compare intraocular pressure lowering effectiveness of a combination drug vs. two~     individual drugs dosed alone.~   "
270608|NCT00047528|"~     To compare intraocular pressure lowering effectiveness of a combination drug vs. two~     individual drugs dosed alone.~   "
270609|NCT00047515|"~     To compare intraocular pressure lowering effectiveness of a combination drug vs. two~     individual drugs dosed alone.~   "
270610|NCT00047749|"~     The purpose of this study is to understand the effects of intrathecal ziconotide (an~     experimental pain medication) when the dose is slowly increased over a 3-week period in~     patients with severe chronic pain. During the weaning phase, the study will also gather~     information about switching from other intrathecal or IT medication (slowly pumped directly~     into the space around the spine) to other systemic pain medication (by mouth or through the~     skin using a patch). After being weaned off current IT medication, patients will be placed on~     IT ziconotide or placebo (non-active substance) as well as being allowed a stable dose of~     systemic pain medications.~      Patients who complete this study may be eligible for long-term ziconotide therapy via~     extension protocol ELN92045-352.~   "
270611|NCT00047736|"~     The purpose of this study is to determine if Tarceva plus standard chemotherapy is more~     effective than standard chemotherapy alone in the treatment of lung cancer.~   "
270612|NCT00047723|"~     The purpose of this trial is to test the safety, tolerability, and effectiveness of~     minocycline compared to placebo in patients with amyotrophic lateral sclerosis (ALS).~   "
270613|NCT00047710|"~     The goal of this clinical research study is to find the highest safe dose of the drug~     Bevacizumab that can be given in combination with chemoradiation for the treatment of~     pancreatic cancer. The effect that this combination treatment has on the tumor will also be~     studied.~   "
270614|NCT00047697|"~     This 11-week study will examine the safety and effectiveness of the medication donepezil~     (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents~     with Autism Spectrum Disorder.~   "
270615|NCT00047684|"~     The purpose of this study is to refine Brief Integrative Therapy (BIT) and to evaluate its~     effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following~     childhood sexual abuse. This study will also promote the development of skills that are~     necessary for increasing quality of life and improving self-esteem.~   "
270616|NCT00047671|"~     This 11-week study aims to determine how genetic factors affect the way African Americans and~     Caucasians with major depression respond to antidepressant medication [citalopram (Celexa®)].~   "
270617|NCT00047658|"~     Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects~     of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects~     of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will~     be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with~     corticosteroids.~   "
270618|NCT00047645|"~     Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b~     administered by subcutaneous injection; compared to placebo in patients with IPF who are~     unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g~     1b group or a placebo group.~   "
270619|NCT00047632|"~     The purposes of this study are to determine: 1) if treatment with interferon gamma-1b plus~     standard chemotherapy (carboplatin and paclitaxel) can increase the overall survival of~     patients with advanced ovarian or primary peritoneal carcinoma compared with chemotherapy~     alone; 2) how effective interferon gamma-1b plus standard chemotherapy is in preventing the~     progression or return of cancer; 3) the effects on quality of life; and 4) the safety of~     interferon gamma-1b combined with standard chemotherapy compared to chemotherapy alone.~   "
270620|NCT00047606|"~     The purpose of this study is to evaluate safety and efficacy of two different IOP lowering~     medications after six weeks of treatment in Caucasian and Japanese subjects.~   "
270621|NCT00047593|"~     The purpose of this study is to evaluate safety and efficacy of two different IOP lowering~     medications after twelve months of treatment in Japanese subjects.~   "
270622|NCT00047619|"~     The purpose of this study is to investigate the use of pulsatile lavage to enhance the~     healing of pressure ulcers in individuals with spinal cord injury (SCI).~      The goals will be achieved using a repeated-measures double-blinded randomized controlled~     study of individuals with SCI who have pelvic region pressure ulcers. A total of 60 subjects~     will be recruited to this study. Participants will be randomly assigned to a treatment or~     control group. Pulsatile lavage treatment will be administered to the treatment group daily~     for a 3 week period. The control group subjects will receive daily sham pulsatile lavage~     treatment for 3 weeks. All subjects will be monitored for a 3 week period and will continue~     to receive routine pressure ulcer care, i.e. dressings and bedrest with a regular turning~     regime during their participation in the study.~      All study participants will be monitored following the study period until complete closure of~     the pressure ulcer is achieved in order to determine total interval to final closure,~     including any surgical procedures required. In addition, the economic effects of pulsatile~     lavage treatment will be evaluated through monitoring of data collected in the Computerized~     Patient Record System (CPRS), including duration of admission, duration of total bedrest~     order and duration of treatment for pressure ulcer. This data will give an initial measure of~     the cost benefits that may be achieved with the use of pulsatile lavage for the treatment of~     pressure ulcers.~      Subjects will be recruited from the Louis Stokes Cleveland Veterans Affairs Medical Center~     (CVAMC). All individuals with spinal cord injury who are admitted to the SCI Unit with pelvic~     region pressure ulcers will be considered eligible for this study. Further selection criteria~     will be employed to screen potential participants as described below. On recruitment subjects~     will be randomly assigned to 2 groups of 20 subjects. The assessment methods employed will be~     the same for each volunteer. One group will participate in the pulsatile lavage intervention,~     the second group will act as controls.~   "
270623|NCT00047580|"~     This study is being conducted to compare the impact of somnolence (sleepiness) on cognition~     (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules~     versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after~     a meal) and in the fasted state (before a meal) in patients with moderate to severe~     spasticity.~   "
270624|NCT00047567|"~     To study the safety and efficacy of zonisamide as adjunctive therapy for children and~     adolescents with bipolar I or II disorder.~   "
270625|NCT00046371|"~     The purpose of this study is to examine the immunological response rate to administration of~     the THERATOPE® vaccine in women with stable metastatic breast cancer who are being treated~     with aromatase inhibitors or Faslodex® and who do not require chemotherapy.~      Post-menopausal women on aromatase inhibitors or Faslodex® alone and pre-menopausal women on~     aromatase inhibitors plus luteinising hormone-releasing hormone (LH/RH)-agonist may be~     eligible to be enrolled.~      Patients must not have had radiotherapy or major surgery within four (4) weeks prior to~     entering the study.~      Information about the safety and tolerability of administration of the THERATOPE® vaccine~     will also be gathered during the course of the study.~   "
270626|NCT00047502|"~     The purpose of this study if to investigate the effect of lonafarnib (SCH66336) in~     combination with Gleevec in the treatment of CML.~   "
270627|NCT00047489|"~     ABT-751 is a new antitumor drug that that interferes with cell division. The goal of this~     clinical research study is to find the highest safe dose of ABT-751 that can be given as a~     treatment for refractory hematologic malignancies. The safety and side effects of ABT-751~     will also be studied.~   "
270628|NCT00047476|"~     To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of~     chemotherapy-related fatigue in adult cancer subjects.~   "
270629|NCT00047463|"~     The purpose of this trial is to work out design issues prior to conducting a definitive phase~     3 trial to determine whether treating sleep-related breathing disorders in people with~     epilepsy results in improvement in seizure control or an improvement in alertness during the~     day.~   "
270630|NCT00047450|"~     The purpose of this study is to evaluate the safety and effectiveness of citalopram (Celexa)~     for the treatment of depressive symptoms in middle-aged and elderly patients with~     schizophrenia.~   "
270631|NCT00047437|"~     The purpose of this study is to determine the long-term safety and effectiveness of exercise~     training for individuals with congestive heart failure (CHF).~   "
270632|NCT00047424|"~     To compare aggressive lowering of low density lipoprotein (LDL) cholesterol and blood~     pressure to the usual care standard in Native American diabetics.~   "
270633|NCT00047411|"~     To compare home use of an automatic external defibrillator (AED) to the use of local~     emergency medical system in treating survivors of sudden cardiac arrest.~   "
270634|NCT00046800|"~     The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in~     patients with relapsed epithelial ovarian cancer.~   "
270635|NCT00046787|"~     The purpose of this study is to determine whether OSI-211 (Liposomal Lurtotecan) is an~     effective and safe treatment for patients with recurrent small cell lung cancer.~   "
270636|NCT00046761|"~     The primary objective of this study is to compare the efficacy of ONO-2506 versus placebo in~     neurological stroke outcome in patients with acute ischemic stroke.~   "
270637|NCT00046748|"~     The purpose of this study is to determine the effect of omalizumab, compared to placebo, on~     clinically significant asthma exacerbation rates in adolescents and adults with asthma.~   "
270638|NCT00046813|"~     The purpose of this study is to test the use of High-Dose versus Regular-Dose Nicotine Patch~     for Nicotine Dependence in Individuals with Schizophrenia or Schizoaffective Disorder~   "
270639|NCT00046774|"~     This study will examine the safety and effects of the monoclonal antibody MRA in patients~     with systemic lupus erythematosus (SLE). Antibodies normally fight invading organisms. In~     autoimmune diseases, such as lupus, however, antibodies attack the body s own tissues. MRA is~     an antibody manufactured in the laboratory that blocks the action of interleukin-6 (IL-6), a~     substance that increases antibody production and is involved in inflammation that may cause~     organ damage in SLE.~      Patients 18 years of age and older with moderately active systemic lupus erythematosus may be~     eligible for this 6-month study. Candidates will be screened with blood and urine tests,~     chest X-ray, electrocardiogram (EKG), and screening tests for certain cancers.~      Participants will receive a total of up to seven infusions of MRA given every 2 weeks in the~     clinic. The MRA is infused over a period of about 1 hour through a catheter (thin plastic~     tube) inserted into an arm vein. Patients will be observed for 1 to 2 hours after each~     infusion for drug side effects. For the first and last infusions, patients will return to the~     clinic for blood tests 24 to 48 hours after the infusion. Additional tests may be done if~     medically indicated.~      Three different doses of MRA will be used in three groups of patients. The first group (4~     patients) will receive the lowest dose. If this dose is well tolerated, a second group (6~     patients) will receive a higher dose. If this dose is also well tolerated, a third group (6~     patients) will receive the highest study dose.~      Patients will be evaluated at various intervals for up to 3 months after the last dose of~     MRA. The follow-up visits will include a review of the patient s medical history, a physical~     examination, blood and urine tests, and an EKG.~   "
270640|NCT00046735|"~     To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week~     cycle in patients with solid tumors that are refractory after standard treatment.~   "
270641|NCT00046722|"~     To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral~     neuropathy.~   "
270642|NCT00046527|"~     Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against~     metastatic breast cancer, as well as other cancers. Because the Taxol formulation of~     paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol,~     prolonged intravenous administration times are required; and because the solvent has caused~     hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer~     medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a~     protein-stabilized material that is suspended in salt water and administered intravenously.~     The time of administration is reduced, the dose of paclitaxel can be higher than is safe for~     Taxol, and there is no premedication required.~      This study will determine the efficacy of this new formulation of paclitaxel, as compared to~     Taxol, for patients with metastatic breast cancer.~      This is an open label comparative study, so patients will be randomly assigned to receive~     either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are~     receiving. Treatment will be repeated every three weeks unless adverse events or treatment~     failure require discontinuing study medication.~   "
270702|NCT00045877|"~     The purpose of this study is to determine the safety and effectiveness of combination therapy~     with Proleukin and Rituxan on patients with low-grade Non-Hodgkin's Lymphoma who have~     previously failed Rituxan treatments.~   "
270643|NCT00046514|"~     The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against~     metastatic breast cancer. However, the Taxol formulation requires prolonged administration~     times, and there are safety problems that have been attributed to the solvent rather than the~     active ingredient, paclitaxel. This is a new formulation of paclitaxel that has been found to~     have fewer safety problems than Taxol, and may be administered safely at higher doses. This~     study will investigate the safety and efficacy of this new formulation of paclitaxel given~     intravenously once a week for three weeks, followed by a rest week. This cycle will be~     repeated until safety problems or treatment failure require that the patient stop therapy.~   "
270644|NCT00046423|"~     This trial will treat patients with advanced (metastatic) cancer with a new chemotherapeutic~     agent that may be more readily tolerated than some standard therapies. Patients will be given~     the new chemotherapeutic medicine once a week, by intravenous route, for three weeks,~     followed by a rest week. Treatment will be repeated in four week cycles if the patient~     improves on the therapy, and if there are no adverse events that require withdrawal of~     medication.~   "
270645|NCT00046709|"~     To find out if it is safe and effective to use smoked marijuana in combination with opioids~     to treat cancer pain. The study will evaluate whether smoked marijuana, when used with~     opioids, will have an effect on pain relief, and to see if marijuana reduces the side effects~     of opioids, which include nausea and/or vomiting.~   "
270646|NCT00046696|"~     A study for patients who have failed standard therapy. If there is no dose limiting~     toxicities the patients will receive further cycles of therapy if there is no evidence of~     disease progression.~   "
270647|NCT00046683|"~     This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus~     chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia~     (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be~     experiencing progression of their B-CLL requiring treatment. Patients who meet all~     eligibility criteria may be randomized on a 1:1 basis to receive either Campath or~     chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more~     investigational sites will be randomized to one of the two treatment arms.~   "
270648|NCT00046540|"~     Liposome Encapsulated SN38 (LE-SN38) is an oncology drug product consisting of the active~     metabolite of irinotecan (CPT-11), a known anticancer drug, encapsulated in a liposome.~     Formulation of a relatively insoluble compound (SN38) and improvement in drug delivery~     (pharmacodynamic profile) may be obtained with liposomal formulations. An improved safety and~     efficacy profile, compared with the pro-drug CPT-11, may be possible. This rationale is~     supported by the results from animal toxicity studies in both the mouse and dog.~      LE-SN38 will be infused intravenously every 3 weeks to assess safety and tolerability of~     study drug until there is disease progression or toxicity requiring early treatment~     discontinuation. Disease status will be assessed after every second cycle of treatment. In~     the event of disease progression, study treatment will be discontinued, all end-of-treatment~     study evaluations will be performed and further treatment options will be reviewed.~   "
270649|NCT00046501|"~     The purpose of the study is to compare the effect in blood sugar control between Lantus and~     twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a~     multiple daily injection setting with fast acting insulin (Lispro)~   "
270650|NCT00046488|"~     To determine what side effects and what clinical effects if any the administration of this~     investigational product, IDEC-152 (an antibody against CD23 which is an important protein on~     leukemia cells and certain cells in the body's immune system), has on the CLL patient~     population.~   "
270651|NCT00046475|"~     We are seeking male and female patients to voluntarily take part in a clinical research~     study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic~     hypotension (low blood pressure while in the upright position) due to Parkinson's disease,~     multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic~     orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness,~     changes in vision and generalized weakness upon standing. The main effect of the drug being~     studied is to increase blood pressure in the upright position so symptoms will decrease.~      The purpose of this clinical study is to further assess the clinical benefit of midodrine~     hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the~     course of the study, participants will receive either ProAmatine® or a placebo. Assessments~     will be made using questionnaires that measure symptom and activity levels. Blood pressure in~     the lying down and standing positions will be measured at each visit.~   "
270652|NCT00046462|"~     The purposes of the study is to determine whether blood sugar control is different between~     Lantus and a third oral anti-diabetic agent when added to patients who fail a~     thiazolidinedione and sulfonylurea or metformin combination.~   "
270653|NCT00046449|"~     A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal~     Affective Disorder~   "
270654|NCT00046670|"~     To examine the relationship between obstructive sleep apnea and lipid metabolism.~   "
270655|NCT00046657|"~     To examine how neighborhood-level factors interact with individual characteristics to predict~     incidence of cardiovascular disease and all-cause mortality.~   "
270656|NCT00046644|"~     To elucidate the mechanisms underlying inter-patient variation in response to montelukast, a~     drug for asthma.~   "
270657|NCT00046631|"~     To investigate the role of community characteristics in physical activity levels of~     adolescent girls.~   "
270658|NCT00046618|"~     To identify new dilated cardiomyopathy genes by genetic linkage and mutational analyses.~   "
270659|NCT00046605|"~     To examine the associations of common variation in inflammation/thrombosis genes with~     intermediate quantitative phenotypes and subclinical coronary atherosclerosis in the Coronary~     Artery Risk Factor Development in Young Adults (CARDIA) Study, a large, bi-racial cohort~     study.~   "
270660|NCT00046592|"~     To determine the mechanisms by which atherosclerotic peripheral artery disease (PAD) causes~     functional impairment and to define the degree to which peripheral artery disease associated~     pathophysiologic findings change over time.~   "
270661|NCT00046579|"~     To better understand the determinants of nutrient intake in black and white adolescent girls~     and to examine the effects of nutrient intake and eating behaviors on obesity, a significant~     risk factor for CVD.~   "
270663|NCT00046553|"~     The purpose of this study is to examine the function of cortisol receptors in post-traumatic~     stress disorder (PTSD).~      Patients with PTSD have neurobiological dysregulation of the hypothalamic-pituitary-adrenal~     (HPA) axis function. High corticotrophin releasing hormone (CRH) levels and decreased~     hippocampal volume are major features of the disorder. The mechanisms responsible for these~     alterations are not known. This study will evaluate the function of cortisol receptors to~     determine their roles in maintaining PTSD HPA axis dysregulation. Three groups of subjects~     will take part in the study: Patients with PTSD, healthy control subjects who were exposed to~     trauma in the past and remained healthy and healthy control subjects who were never~     traumatized~      At study entry, the cerebral spinal fluid (CSF) of all participants will be sampled and~     evaluated. Participants will also undergo a magnetic resonance imaging (MRI) scan of the~     brain as well as eye blink trace conditioning and neuropsychological tests.~      Participants will be admitted to the Clinical Center for two nights on three different~     occasions. At each overnight visits, blood levels of stress hormones will be measured every~     hour for 26 hours after medication or placebo are given. This will be the end of the study~     for both groups of healthy control subjects, with the exception that they may be asked to~     repeat neuropsychologic and eye blink tests after 12 weeks.~      Participants with PTSD will receive paroxetine for 10 weeks. After 10 weeks these~     participants will be reevaluated in exactly the same way as before treatment (except they~     will not repeat the MRI scan).~   "
270664|NCT00046436|"~     This study will look at how well the OraQuick HIV 1/2 Antibody rapid test works and how women~     accept being tested for HIV late in pregnancy and during labor. For women with positive test~     results, the study will look at whether or not these women accept anti-HIV drugs and which~     drugs they receive.~   "
270665|NCT00046384|"~     The purpose of this study is to learn if aripiprazole is effective in the treatment of~     patients with acute symptoms of Bipolar Disorder.~   "
270666|NCT00046410|"~     This study will compare the safety of coronary artery bypass grafting (CABG) with and without~     the use of heart-lung bypass during surgery (on- versus off-pump surgery). CABG carries a~     risk of stroke and of cognition problems (problems with thought processes) that may be caused~     by small strokes. This study will use magnetic resonance imaging (MRI) to determine whether~     the newer technique of off-pump CABG carries a lower risk of stroke than on-pump CABG. The~     study will also evaluate the relative risk (the risk of stroke in CABG patients exposed to~     the following factors compared to CABG patients who are not exposed to the following factors)~     of other factors for stroke and cognitive problems, such as atherosclerosis (hardening of the~     arteries), age, sex, pre-surgery intellectual function and performance, previous stroke,~     chronic kidney failure, diabetes, high blood pressure, carotid artery disease (narrowing of~     the neck arteries to the brain), peripheral blood vessel disease, and micro embolism (tiny~     blood clots that travel to the brain).~      Patients 18 years of age and older with chest pain or narrowing of the coronary arteries who~     are scheduled to undergo CABG surgery may be eligible for this study.~      Participants will be randomly assigned to have CABG either on-pump or off-pump. They will~     undergo the following tests and procedures:~        -  Tests of cognitive and neurological function before surgery and 6 months after surgery~        -  Blood tests to look for cytokines (substances that indicate inflammation) before~          surgery, immediately after surgery and 1 day after surgery~        -  MRI scans to detect stroke before surgery, 1 day after surgery and 1 month after~          surgery.~      MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural~     and chemical changes in tissue. For the procedure, the patient lies on a table that slides~     into the scanner-a metal cylinder surrounded by a magnetic field. Earplugs are worn to muffle~     the loud knocking sounds that occur when the pictures are being taken. The scan, taken before~     surgery, will last about 20 minutes; the two after surgery take about 10 minutes to perform.~   "
270667|NCT00046397|"~     This study will test the safety of an experimental vaccine called Modified Vaccinia Virus~     Ankara (MVA) for use against the smallpox virus. It will also investigate how many injections~     of MVA are needed to produce immunity against vaccinia virus, which is closely related to the~     smallpox virus. An effective smallpox vaccine exists, but it can cause side effects that, on~     rare occasions, can be life-threatening. The FDA gave new license approval for Dryvax on~     10/25/02, but has not been used in the general population since smallpox was eradicated~     worldwide. Both the MVA and Dryvax® (Registered Trademark) vaccines are made using the~     vaccinia virus, however the MVA vaccine contains a more attenuated, or weakened, form of the~     virus. [http://www.fda.gov/cber/products/smalwye102502.htm]~      Healthy normal volunteers between 18 and 30 years of age, who have never been vaccinated with~     a smallpox vaccine, may be eligible for this study. Candidates will be screened with a~     medical history, physical examination, and blood and urine tests, including an HIV test and a~     pregnancy test for women of childbearing potential.~      MVA, placebo and Dryvax® (Registered Trademark) will be administered by different methods.~     The MVA vaccine and placebo are injected into an arm muscle with a needle and syringe. The~     Dryvax® (Registered Trademark) vaccine is administered, as it was for many years, with a~     special forked needle that is poked lightly into the skin of the upper arm, usually 15 times,~     in a process called scarification. When the vaccine works, a small pus-filled blister forms,~     followed by a scab and then scarring at the site of the vaccination. The formation of the~     blister and scab is called a take, indicating that the vaccine is effective and is evidence~     of the development of immunity. The development of a take suggests that an individual will be~     protected against smallpox for at least a few years. If scarification does not take, it can~     either mean that the person already has immunity or that the vaccine did not work.~      Participants will be assigned to groups, as well as, product randomly. For instance, the~     first study participant could be enrolled into group 3. The Dryvax® (Registered Trademark)~     dose is given as a challenge to see if the person has a take. A reduced take response or no~     take, could suggest that MVA is able to produce an immune response. The dosing schedules vary~     from 12 to 24 weeks and volunteers are in the study a total of 24 to 36 weeks, depending on~     the number of injections.~      Participants will be observed for at least 1 hour after each injection. They will come to the~     clinic a week after MVA or placebo injections and at least twice a week after Dryvax®~     (Registered Trademark) for about 21 days to have the injection site evaluated and~     photographed. At each visit, participants will be asked about how they are feeling and if~     they are taking any medications. Blood and urine tests will be done on injection days and at~     follow up visits scheduled 1 and 4 weeks after each immunization as well as 12 weeks after~     the Dryvax® (Registered Trademark) challenge dose. Additional tests may be done between~     visits if medically necessary.~   "
270668|NCT00046345|"~     The purpose of this clinical research study is to provide atazanavir to patients infected~     with human immunodeficiency virus (HIV) whose antiviral medications are no longer working to~     control HIV activity within the body and who are unable to create a new treatment regimen~     using other available anti-HIV drugs, because of either side effects or treatment failure~     previously taken. The safety of this treatment will also be studied.~   "
270669|NCT00046332|"~     This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus~     placebo in HIV-infected patients who have not previously taken anti-HIV medications.~   "
270670|NCT00046319|"~     The purpose of this study is to determine if treating patients suffering from moderate to~     severe pulmonary arterial hypertension with BSF 208075 will improve the patients' ability to~     exercise.~   "
270671|NCT00046306|"~     Workplace exposure to secondhand cigarette smoke or environmental tobacco smoke (ETS)is~     widespread, effecting between 19 and 49% of the U.S. workforce. The first part of this study~     is designed to test whether exposure to ETS in the workplace effects a person's risk of~     developing chronic diseases such as cardiovascular disease and cancer. The second part of~     this study is designed to test whether antioxidant supplementation in this group of ETS~     exposed individuals can reduce their risk of developing chronic disease.~      The study will look at 375 non-smokers who either work on a casino floor or as bartenders or~     cocktail servers. Initial baseline data will be collected (questionnaires and blood samples~     taken) and the subjects will be randomized into one of three groups, placebo, low antioxidant~     supplementation and high antioxidant supplementation. They will be followed over a two-year~     period, coming in for follow-up testing every six months. Statistical analysis will be~     conducted to see whether this group of ETS exposed individuals has a greater risk of~     developing chronic disease and whether the use of antioxidant supplements can moderate any~     risks.~   "
270672|NCT00046358|"~     The purpose of this study is to determine whether short-term use of the drugs ibuprofen and~     lovastatin affects levels of a protein called beta-amyloid in people who are at risk for~     developing Alzheimer's Disease (AD).~   "
270673|NCT00046293|"~     This study will determine the dose of Retavase that can safely be combined with ReoPro in~     treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and~     Retavase are currently approved by the Food and Drug Administration to treat heart problems~     caused by blockage of heart arteries. The only therapy approved by the Food and Drug~     Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment is~     effective only if begun within 3 hours of onset of the stroke, however, and most patients do~     not get to the hospital early enough to benefit from it.~      Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between~     3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be~     screened with a medical history and physical examination, blood tests, rating of neurological~     deficits such as cognition deficits or problems walking that resulted from the stroke, and a~     computed tomography (CT) scan of the head. CT involves the use of specialized X-rays to~     obtain images of the brain. The patient lies on a table that is moved into a cylindrical~     machine (the scanner) for the imaging study, which usually takes about 5 to 10 minutes.~      All participants will receive 0.25 mg/kg of ReoPro (maximum dose of 30 mg). The drug is~     infused into the vein over 12 hours. Some patients will also receive one of four doses of~     Retavase, which may boost the effectiveness of ReoPro in opening the blocked blood vessel.~     Retavase is given through a needle in the vein over 2 minutes. Patients will be monitored~     daily until discharge from the hospital, or until day 5, whichever is earlier. Assessments~     will include physical examinations, blood tests to examine factors involved in blood~     clotting, and CT scans to evaluate both the response to treatment and drug side effects. They~     will return for a follow-up examination and CT scan 30 days after treatment.~   "
270676|NCT00046254|"~     The purpose of this study is to evaluate whether zoledronic acid given once yearly for two~     years to men and women after surgical repair of a recent hip fracture will significantly~     reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive~     vitamin D and calcium.~   "
270677|NCT00046241|"~     This is a placebo controlled study evaluating the effectiveness of medication in preventing~     depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).~   "
270678|NCT00046228|"~     The purpose of this study is to determine whether abciximab given in combination with~     reteplase, before patients have a coronary intervention (a standard treatment where a~     catheter is inserted into the heart artery to get blood flowing past the clot), is safe and~     effective in the treatment of heart attacks compared to only abciximab given during coronary~     intervention.~   "
270679|NCT00046215|"~     This study will use transcranial magnetic stimulation (TMS) to examine the relationship~     between cognitive processing and motor control by determining whether a part of the brain~     called the premotor cortex is essential to imagining movement. TMS, described below, is a~     method of brain stimulation that can temporarily inhibit brain functions of the area~     underlying the stimulator.~      Healthy right-handed normal volunteers may be eligible for this study. Candidates will be~     screened with a medical history, neurological examination, and test of finger dexterity.~      Participants will perform a sequential finger tapping movement in response to a series of~     numbers (stimuli) displayed on a computer monitor. After 10 stimuli, they will be asked which~     finger they tapped last. They will then imagine the same finger tapping movement and will be~     asked which finger they tapped last in their imagination. During these exercises,~     participants will undergo transcranial magnetic stimulation. For this procedure, the subject~     is seated comfortably in a chair. A wire coil is placed on the scalp and a brief electrical~     current is passed through the coil, creating a magnetic pulse that passes into the brain.~     This generates a very small electrical current in the brain, which briefly disrupts the~     function of the brain cells in the stimulated area. The stimulation may cause twitching in~     arm or leg muscles. During the stimulation, the electrical activity of muscles is recorded~     with a computer or other recording device, using electrodes attached to the skin with tape.~      Subjects will complete eight experimental blocks of testing. One block consists of 20~     experimental trials, with each trial lasting about 10 seconds. Five pairs of TMS stimuli are~     given per trial, with pulses delivered in short bursts of one second each. After each block,~     subjects draw a mark on a line on paper, showing how much attention they are paying, how much~     fatigue they are experiencing, and how well they think they are executing the tasks. Each TMS~     session takes up to 3.5 hours.~      Before the TMS session, participants will undergo magnetic resonance imaging (MRI) for use in~     determining proper placement of the TMS coil. MRI uses a strong magnetic field and radio~     waves to obtain images of body organs and tissues. For this procedure, the subject lies still~     in a narrow metal cylinder (the scanner) for about 30 minutes during the scan.~   "
270680|NCT00046202|"~     This study will investigate the cause and medical problems associated with a group of genetic~     disorders known as inborn errors of cholesterol synthesis, in which the body does not produce~     cholesterol. People with this disorder may have birth defects and learning and behavioral~     problems.~      People with an inborn error of cholesterol synthesis and related disorders, including~     Smith-Lemli-Opitz syndrome, lathosterolosis, desmosterolosis, X-linked dominant~     chondrodysplasia, CHILD syndrome, Greenberg dysplasia, and some cases of Antley-Bixler~     syndrome, may be eligible for this study. People who are carriers of the disorders also may~     enroll.~      Participants and family members will provide blood and urine samples, as well as other tissue~     samples collected during medically indicated procedures such as biopsy or surgery. These~     tissues may include, for example, gallstones, cataracts, cerebrospinal fluid, amniotic fluid,~     lymph tissue, and DNA samples. In rare instances, a skin biopsy may be requested to aid in~     establishing a diagnosis.~      Medical information will also be gathered from medical records, photographs, and X-rays.~   "
270681|NCT00046189|"~     This study will determine if family members of patients with xeroderma pigmentosum (XP) have~     various abnormalities, including: skin abnormalities; nervous system abnormalities, such as~     hearing problems; skin, eye, or internal cancers, or other changes. XP is a rare inherited~     disease that involves an inability to repair damage to cell DNA (genetic material). It can~     affect several organ systems, including the skin, eye, nervous system, and bones. Patients~     have a more than thousand-fold increase in frequency in all major skin cancers.~      Parents of patients with XP are carriers of the abnormal XP gene. Other family members may~     also be carriers of the abnormal XP gene. Carriers do not develop the disease themselves;~     symptoms develop only in children who have inherited the faulty gene from both parents. This~     study will try to clarify the genetic basis for XP and to understand the increased frequency~     of cancer in the disease.~      XP patients who have been evaluated at the NIH Clinical Center and their relatives are~     eligible for this study. Newly diagnosed XP patients are also eligible. Spouses of relatives~     will also be included as control subjects.~      Patients and their family members will undergo some or all of the following procedures:~        -  Parental permission to review the child s relevant medical records and pathology~          material from treatments or surgery for cancer or other related illnesses~        -  Medical history and physical examination, with particular attention to the skin and~          possible eye, hearing or neurological examinations~        -  Photographs to document skin and other physical findings~        -  Nuclear medicine scans to evaluate the brain and nervous system~        -  X-rays of the skull or other parts of the body~        -  Nervous system testing with an electroencephalogram (EEG), electroretinogram (ERG),~          electromyogram (EMG) or nerve conduction velocity measurement~        -  Collection of blood and skin samples for gene studies~        -  Establishment of cell lines from collected blood or tissues to study DNA repair, skin~          cancer, cancers related to XP, immune defects, and related studies.~        -  Biopsy (surgical removal of a small piece of tissue) of suspicious skin lesions for~          examination under a microscope~        -  Collection of a cheek cell sample, obtained by twirling a soft brush against the inside~          of the cheek~        -  Collection of a hair sample for microscopic examination and composition analysis~        -  Surgery to treat skin cancers or other lesions~   "
270682|NCT00046176|"~     This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose~     combination tablet administered once-a-day versus the individual tablets administered~     twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1~     infected patients.~   "
270683|NCT00046163|"~     We are seeking male and female patients to voluntarily take part in a clinical research~     study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic~     hypotension (low blood pressure while in the upright position) due to Parkinson's disease,~     multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic~     orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness,~     changes in vision and generalized weakness upon standing. The main effect of the drug being~     studied is to increase blood pressure in the upright position so symptoms will decrease.~      The purpose of this clinical study is to further assess the clinical effect of high dose~     midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension.~     During the course of the study, participants will receive either ProAmatine® or a placebo.~     Assessments will be made using questionnaires that measure symptom and activity levels. Blood~     pressure in the lying down, sitting and standing positions will be measured. Patients will~     also complete standing time assessments. They will be asked to remain standing without moving~     until they feel sufficiently lightheaded, or dizzy, or feel faint so that they would feel~     more comfortable sitting down.~   "
270684|NCT00046150|"~     The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used~     in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood~     glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events,~     laboratory data, and vital signs.~   "
270685|NCT00046137|"~     The purpose of this study is to compare treatment with both teriparatide and raloxifene with~     teriparatide alone. The study will evaluate any side effects that may be associated with the~     two drugs and may help to determine whether teriparatide and raloxifene together can help~     patients with osteoporosis more than teriparatide alone.~   "
270686|NCT00046124|"~     This prospective cohort study assesses the effects of exposure to organophosphate (OP)~     pesticides on adverse reproductive outcomes in both male and female agricultural workers in~     China. We will enroll women and their spouses, who are attempting to become pregnant, and~     observe reproductive endpoints including (1) semen parameters (concentration, total count,~     motility, progression and morphology), (2) menstrual disorders (oligomenorrhea, amenorrhea,~     polymenorrhea, intermenstrual bleeding, prolonged menstrual bleeding, dysmenorrhea, and~     irregular menstruation); (3) alterations in hormone patterns including reduced estrogen~     excretion (REE), anovulation, abnormal luteal phase (ALP), and abnormal follicular phase~     (AFP) in women and abnormalities of LH, FSH, TSH, SHBG, inhibin-B and testosterone in men;~     (4) fecundability; and (5) pregnancy outcomes including spontaneous abortion, preterm~     delivery, low birth weight, and intrauterine growth retardation.~   "
270687|NCT00046111|"~     The purpose of this study is to compare two capsules of topotecan made by slightly different~     methods. This will be done by giving the drug made by the two different methods to patients~     orally and testing blood levels.~   "
270688|NCT00046085|"~     This study evaluated the benefits of providing relatives of patients diagnosed with~     schizophrenia the opportunity to interact with each other using the Internet. It was~     hypothesized that patients whose relatives had access to the internet intervention would have~     reduced symptoms and greater community tenure, compared to their counterparts who did not~     have relative access to the internet education and support program. We also collected~     information on how frequently the relatives used the website and how well they liked its~     features.~   "
270689|NCT00046072|"~     Sepsis is a serious condition where there is inflammation and damage to body tissue, usually~     caused by an infection. This infection can lead to decreased function of vital body organs~     and in some cases may lead to permanent health problems or death.~      Much of the injury is due to endotoxin, a harmful substance produced by certain types of~     bacteria. An endotoxin antagonist is designed to block the effects of endotoxin.~      This study is designed to study the safety and efficacy when treating patients with severe~     sepsis.~   "
270690|NCT00046059|"~     Attention Deficit Hyperactivity Disorder (ADHD) is the most common behavioral disorder in~     childhood, affecting 3-5% of children between the ages of 7 and 17. Family studies suggest~     that there is a genetic component to ADHD. Scientists believe that it is a complex disorder~     in which two or more genes may be involved.~      Potentially eligible families will be asked to give written consent to participate and will~     be asked to complete questionnaires for each member in the family. In addition, an interview~     will be administered to the parent of minors enrolled in the study to determine their~     eligibility for being in the study. This screening tool is computerized and will take~     approximately 45 minutes to administer per child.~      Once screenings are completed, a blood collection kit will be sent to the family to take to~     their local medical care provider, have blood samples drawn and sent to NIH. There is no cost~     to the family to participate. We would like to enroll entire families, with both parents and~     all children.~   "
270691|NCT00046033|"~     The purpose of this study is to see if adjusting the dose of lopinavir/ritonavir (LPV/r) has~     a better effect on lowering HIV viral load (the amount of HIV in the blood) compared to~     taking the standard FDA-approved LPV/r dose. This study will also compare the safety and~     tolerability of these two types of dosing.~   "
270692|NCT00046020|"~     The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER~     in achieving and sustaining remission (wellness) in patients with recurrent major depression~   "
270693|NCT00045994|"~     The purpose of this study is to evaluate the safety and efficacy of ALT-711 in the treatment~     of isolated systolic hypertension in a formal study in patients with left ventricular~     hypertrophy. Eligible patients will be randomized to double-blind treatment once daily for 6~     months with oral ALT-711 (210 mg) or placebo.~   "
270694|NCT00045981|"~     The purpose of this study is to evaluate the safety and efficacy of ALT-711 in the treatment~     of isolated systolic hypertension in a formal dose-ranging study in patients without left~     ventricular hypertrophy. Eligible patients will be randomized to double-blind treatment once~     daily for 6 months with oral ALT-711 (35, 70, 140, or 210 mg) or placebo.~   "
270695|NCT00045968|"~     The primary purpose of the study is to determine the efficacy of an investigational therapy~     called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated.~     Patients must enter screening at a participating site prior to surgical resection of the~     tumor. Patients will receive the standard of care, including radiation and Temodar therapy~     and two out of three will additionally receive DCVax-L, with the remaining one third~     receiving a placebo. Patients randomized to the placebo arm will have the option to receive~     DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for~     patients with brain cancer is sometimes also referred to as DCVax-Brain)~   "
270696|NCT00045955|"~     The purpose of this study is to assess the long-term safety performance of fexofenadine~     compared to montelukast in subjects with asthma~   "
270697|NCT00045942|"~     CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at~     least one participant showed a clinical response, four more participants were recruited to~     stage 2. The trial was to be stopped if no participants showed a response in stage 1. POC was~     achieved if at least 2 participants out of 12 responded. In PKC412A2104E1, participants with~     AML or high risk MDS with wild-type or mutant FTL3 who had not previously received a FLT3~     inhibitor were randomized to receive continuous twice daily oral doses of either 50 or 100 mg~     midostaurin in 1 28-day cycle regimen. Participants were to be treated until disease~     progression or the occurrence of unacceptable treatment-related toxicity. PKC412A2104 E2~     contained 2 dosing regimens: 1) intra-participant midostaurin dose escalation and 2)~     midostaurin with itraconazole in participants with AML and high risk MDS irrespective of FLT3~     status. Eligible participants were alternately assigned to the regimens. At the~     Investigator's discretion, intra-participant dose escalation was allowed for any previously~     enrolled CPKC412A2104E1 participant receiving midostaurin at the time of the approval of~     amendment 4. Participants were treated until the time of disease progression.~   "
270705|NCT00045812|"~     This study will test the safety and effectiveness of SCH-58235 (Ezetimibe) in lowering~     sitosterol, plant sterol and cholesterol blood levels in patients with homozygous~     sitosterolemia when added to the patients' current treatment regimen. Homozygous~     sitosterolemia is an inherited disorder of sterol metabolism in which an excess of many plant~     sterols, including sitosterol, is absorbed and not enough excreted. (Sterols are substances~     used to form hormones, vitamins and membranes found in animal and plant lipids.). Patients~     can develop atherosclerosis with coronary heart disease as early as childhood, as well as~     other problems including arthritis, arthralgia, and tendon xanthomas (lipid deposits).~     Current sitosterolemia treatments may include a low sterol diet, medications, intestinal~     surgery, or a combination of these. Ezetimibe is a member of a new class of drugs called~     specific cholesterol absorption inhibitors that may lower cholesterol, sitosterol and other~     plant sterol blood levels.~      Patients with homozygous sitosterolemia 10 years of age and older may be eligible for this~     study. Participants will have a medical history and physical examination and will be randomly~     assigned to one of two treatment groups. One group, which will include about 80 percent of~     all study participants, will take 10 mg of Ezetimibe a day, and the second group (20 percent~     of participants) will take a placebo (an inactive look-a-like pill).~      Patients will have 7 clinic visits during the 12-week study, when some or all of the~     following procedures and tests will be done:~        -  Measurement of vital signs (heart rate, blood pressure, breathing rate and temperature)~        -  Dietary maintenance - interview about how well that patient is adhering to the diet~        -  Medication review - interview about other medications the patient is taking~        -  Blood draw for tests~        -  Urine sample for tests~        -  Pregnancy test for women of childbearing potential~        -  Electrocardiogram (ECG) to measure the electrical activity of the heart~        -  Blood draw to determine sitosterol, other plant sterol levels, and lipid levels~          (cholesterol and other blood lipid concentrations)~        -  Xanthoma measurement (with a ruler and X-ray of the foot)~   "
270706|NCT00045799|"~     Critically ill patients are at an increased risk of having upper gastrointestinal (GI)~     bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through~     intravenous infusion, is the only drug that the FDA has approved for the prevention of upper~     GI bleeding in critically ill patients. The present trial is intended to assess the safety~     and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this~     indication.~   "
270707|NCT00045786|"~     The primary objective of the study is to assess the safety of CC-1088 to patients with~     myelodysplastic syndromes (MDS).~   "
270708|NCT00045773|"~     This 12-week study will evaluate the effectiveness of sertraline (Zoloft®) for treatment of~     depression associated with small vascular lesions in the brain (vascular depression).~   "
270709|NCT00045760|"~     Severe sepsis is defined as a systemic inflammatory response syndrome that results from~     infection and is associated with acute organ dysfunction. It usually results from bacterial~     infections, but it may occur in response to other pathogens, such as fungi, viruses, and~     parasites.~   "
270710|NCT00044928|"~     A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal~     infection.~   "
270711|NCT00044915|"~     The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic~     stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1~     ratio. The total treatment period wil be 72 hours.~   "
270712|NCT00044902|"~     Epratuzumab is currently being studied in combination with rituximab, for the treatment of~     patients with low-grade NHL who failed previous chemotherapy and have never received~     rituximab or who received rituximab as a single agent or in combination with chemotherapy as~     their last treatment and who demonstrated a partial response or complete response for at~     least 12 months.~   "
270713|NCT00044889|"~     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the~     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia~     (ALL) who have had at least 2 prior treatment regimens.~      This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with~     refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be~     refractory to one or two induction regimens, or have relapsed < one year from the date of~     confirmation of the initial complete remission (CR). There will be two phases in this study -~     an Induction phase and a Consolidation phase.~   "
270714|NCT00044863|"~     This is a phase II, multicenter, target enrollment of 250 evaluable patients, open-label~     study of cetuximab in patients with refractory, metastatic colorectal carcinoma. Based on~     prior studies, we predict that 70 to 75% of patients will be EGFR-positive. Patients must~     have documented failure after receiving either at least two chemotherapy regimens for~     metastatic disease or adjuvant therapy plus one chemotherapy regimen for metastatic disease~     provided that the patient progressed within 6 months of completing adjuvant therapy. Prior~     chemotherapy must have included irinotecan, oxaliplatin, and a fluoropyrimidine.~      Patients will receive an initial dose of cetuximab, 400 mg/m2, intravenously (i.v.) over 120~     minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes.~     Patients who experience unacceptable toxicity or who have progressive disease will not~     receive further cetuximab therapy.~      Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on~     cetuximab therapy. Patients with stable disease or a partial or complete response may~     continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued~     because of toxicity. Patients who have a partial or complete response must have a~     confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating~     a response.~      In addition, there is a pharmacokinetic companion protocol which will determine the trough~     and peak levels of cetuximab in 25 patients enrolled in the study at four to eight centers. A~     pharmacologic serum sample for the determination of levels of cetuximab will be obtained~     prior to the initial, fourth and sixth cetuximab infusions and 1 hour following the~     completion of the initial, fourth and sixth cetuximab infusions in the first course; and~     prior to and 1 hour post the completion of the first cetuximab infusion of each subsequent~     course of therapy. A course of therapy is defined as six weekly infusions of cetuximab~     monotherapy. ImClone will perform the pharmacokinetic analyses.~   "
270715|NCT00044837|"~     The purpose of this study is to find out if the anti-HIV drugs nelfinavir (NFV),~     lopinavir/ritonavir (LPV/r), and efavirenz (EFV) change the amount of estrogen in the blood~     when taken along with hormone replacement therapy (HRT) for menopause.~      HRT can be helpful for treating bothersome symptoms of menopause. However, it is not~     routinely used in HIV-infected postmenopausal women because it is not known how HRT interacts~     with anti-HIV drugs. The information obtained from this study will help doctors make~     recommendations for HRT in postmenopausal HIV-infected women.~   "
270735|NCT00044564|"~     In patients with renal cell cancer, most frequent methods of treatment include surgery,~     chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered~     to be radioresistant and chemoresistant. In patients with metastatic disease, the options are~     limited. The taxanes are among the most commonly used class of chemotherapy agents in~     clinical oncology today but they are not effective in renal cancers; the development of Bay~     59-8862 targets taxane-resistant tumors and the current protocol is designed to test the~     safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.~   "
270736|NCT00044551|"~     Almost two-thirds of lymphoma cases are Non-Hodgkin's Lymphomas (NHL). NHL is a malignant~     process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence~     and mortality rates from NHL are highest in developed countries. While many patients with~     aggressive NHL are curable with initial anthracycline-containing regimens, the majority of~     patients will relapse or prove refractory to initial therapy. The prognosis of patients with~     disease recurrence following a multidrug regimen is also limited. The current protocol is~     designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive~     Refractory Non-Hodgkin's Lymphoma.~   "
270716|NCT00044876|"~     Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in~     premenopausal women. These tumors may cause bleeding, pelvic pain and pressure. Because~     fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels~     (like GnRH analog) cause fibroids to shrink and so may relieve symptoms. However, such~     medication can only be given short-term and has inconvenient side effects such as~     hot-flushes. Thus, many women with symptomatic fibroids choose to have them removed~     surgically, either individually or by removing the uterus via hysterectomy.~      The study evaluates a new medical treatment for fibroids using the progesterone receptor~     modulator CDB-2914. A similar compound, mifepristone (Registered Trademark), reduced fibroid~     size when given for twelve weeks. This study will compare fibroid size, hormone levels and~     symptoms before and during daily administration of CDB-2914 (10 or 25 mg) or placebo for 10 -~     14 weeks. To do this, women will undergo MRI and a saline hysterosonogram (ultrasound with~     fluid) of the uterus before and at the end of the treatment; they will have blood drawn every~     7 - 14 days, and will fill out a symptom calendar at home. Hysterectomy will be performed at~     the end of the treatment to evaluate the effects of the medication on the uterine and fibroid~     tissues, and to provide treatment for the study participant. Women will be randomly assigned~     to the treatment groups; during the treatment period neither the participants nor the~     investigators will know the type of treatment that a woman receives.~   "
270717|NCT00044798|"~     This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic~     stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of~     depression associated with small vascular lesions in the brain (vascular depression).~   "
270718|NCT00044785|"~     CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for~     colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could~     increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU,~     leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well~     tolerated and therefore potentially increase effectiveness.~   "
270719|NCT00044772|"~     The primary objective is to determine the efficacy, safety, and tolerability of venlafaxine~     extended release (ER) capsules in the treatment of outpatients with panic disorder (PD) in~     comparison to those of placebo.~   "
270720|NCT00044759|"~     To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered~     intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for~     the empiric treatment of neutropenic fever in patients with a hematologic malignancy or~     lymphoma.~   "
270721|NCT00044746|"~     Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy~     and Safety data in Diabetic Inpatients.~   "
270722|NCT00044733|"~     The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in~     relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9~     mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms~     of the number of patients attaining a complete (CR) or morphological (CRp) remission.~   "
270723|NCT00044720|"~     The incidence of efficacy failure at 12 months between two regimens.~   "
270724|NCT00044707|"~     This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect~     of pramlintide on the pharmacokinetics of an orally administered medication~   "
270725|NCT00044694|"~     This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response~     study to examine the effects on glucose control of AC2993 as compared to placebo in patients~     with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with~     metformin for at least 3 months prior to screening. Patients whose diabetes management~     consists of diet and exercise will also be eligible for this study.~   "
270726|NCT00044681|"~     The purpose of this study is to evaluate the effectiveness and safety of risperidone to~     augment SSRI therapy in patients with treatment-resistant depression and to demonstrate the~     long-term maintenance effect of risperidone as augmentation therapy compared with placebo~     augmentation in these patients.~   "
270727|NCT00044668|"~     This multi-center, open-label study is designed to examine the effects on long-term glucose~     control and safety of AC2993 in patients with type 2 diabetes treated with metformin,~     sulfonylurea, or metformin and sulfonylurea combination.~   "
270728|NCT00044655|"~     This study will evaluate the effectiveness of switching medications in decreasing~     schizophrenia symptoms in individuals who are currently taking an antipsychotic medication~     for the treatment of schizophrenia.~   "
270729|NCT00044642|"~     This study will compare the effects of an acute dose of lorazepam to a placebo in elderly~     patients with generalized anxiety disorder (GAD).~   "
270730|NCT00044629|"~     This study will determine how sleeping pills can be combined with nondrug treatments to~     maximize the benefits of therapy for insomnia.~   "
270731|NCT00044616|"~     This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®),~     lithium, the combination of these two medications, and placebo in treating and preventing~     recurrent depressive episodes in people with bipolar type II disorder.~   "
270732|NCT00044603|"~     The goal of this study is to examine the effects of in utero and postnatal exposure to~     environmental pollutants in a cohort of pregnant women and their newborns in Krakow, Poland~   "
270733|NCT00044590|"~     Parkinson's disease (PD) occurrence is higher in rural than in urban populations of~     industrialized countries. Epidemiologic and human tissue studies suggest that pesticides may~     be responsible for causing dopaminergic cell death at increased rates. While many~     pathophysiologic pathways may be involved in the neurodegeneration responsible for PD,~     genetic factors are likely to determine a general susceptibility to neurodegeneration.~   "
270734|NCT00044577|"~     A 48-week study to investigate the safety and effectiveness of a new compact formulation of~     two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment~     for their HIV infection.~   "
270783|NCT00043927|"~     This study will gather and compare data about the effectiveness and safety of two different~     treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received~     previous chemotherapy. One treatment will use an investigational drug in combination with an~     FDA approved chemotherapy. The other treatment will use a combination of two FDA approved~     chemotherapy drugs.~   "
270737|NCT00044538|"~     Lung cancer is among the most common cancers in the world and its incidence continues to~     increase. Chemotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) has been under~     investigation for several decades and several new drugs with activity in NSCLC have been~     identified. These include the taxanes, which are among the most commonly used class of~     chemotherapy agents in clinical oncology today. The usefulness of the taxanes is limited by~     the development of tumor resistance to these agents. This phase II trial with BAY 59-8862~     will be conducted to determine the anti-tumor efficacy of BAY 59-8862 in taxane-resistant~     NSCLC.~   "
270738|NCT00044525|"~     Breast cancer is the most common form of cancer among women in developing countries,~     accounting for approximately one-fifth of all female cancers in the United States. Although~     mortality rates are declining in some countries, it remains the leading cause of death in~     women aged 40-55 years. The median survival for women with metastatic breast cancer is 2-3~     years but there is significant variability in this population. The primary goals of treatment~     in patients with metastatic breast cancer are improvement or maintenance of quality of life~     and prolongation of survival. The taxanes, paclitaxel and docetaxel, were incorporated into~     the treatment of metastatic breast cancer in the 1990's. The usefulness of the taxanes is~     limited by the development of tumor resistance to these agents. This phase II trial with~     BAY59-8862 will be conducted to determine the anti-tumor efficacy of BAY59-8862 in~     taxane-resistant metastatic breast cancer.~   "
270739|NCT00044512|"~     Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response~     or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular~     carcinoma.~   "
270740|NCT00044486|"~     This trial is in high risk patients to determine the safety and efficacy of posaconazole vs.~     fluconazole in the prophylaxis against development of invasive fungal infections.~      Profound, prolonged neutropenia (Absolute neutrophil count<500 cells/cubic mm for at least 7~     days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic~     syndrome.~      Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or~     probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100~     days of randomization as determined by external expert review.~   "
270741|NCT00044473|"~     The purpose of the study is to assess the rate of elimination of bacteria by levofloxacin in~     middle ear fluid of children with a rapid and severe onset of infection and inflammation of~     the middle ear who are at high risk for infections that are difficult to treat.~   "
270742|NCT00044460|"~     The purpose of this study is to gain safety and efficacy information in patients with type 2~     diabetes, who have not previously taken any oral antidiabetic medications, and who have an~     HbA1c value of greater than or equal to 10%, despite diet and exercise.~   "
270743|NCT00044447|"~     The purpose of this study is to assess the efficacy and safety of Amaryl when added to~     Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM)~     patients.~   "
270744|NCT00044434|"~     The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in~     patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients~     will receive either a time-released bupropion or placebo. Both groups will receive nicotine~     replacement therapy during the 9 week study. A final followup assessment will be conducted 6~     months from the start of treatment.~   "
270745|NCT00044421|"~     The purpose of this protocol is to determine if an investigational drug is effective in~     treating nerve malfunction in diabetes.~   "
270746|NCT00044408|"~     The purpose of this protocol is to determine if an investigational drug known as LY333531 is~     effective in treating nerve malfunction in diabetes.~   "
270747|NCT00044395|"~     The purpose of this protocol is to determine if an investigational drug is effective in~     treating nerve malfunction in diabetes.~   "
270748|NCT00044382|"~     To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience~     erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .~   "
270749|NCT00044369|"~     Varicose veins in the scrotum (varicocele) are responsible for >20% of male infertility in~     the US. Varicocele are associated with decreased sperm number and markedly reduced sperm~     fertilizing ability. Surgical repair or removal of varicocele restores fertility in only 1/3~     of cases. The goal of this study is to identify markers that predict the outcome of variocele~     correction. This would offer considerable health cost savings.~      Based on preliminary findings, we will obtain testis biopsies and semen specimens from~     infertile men with varicocele and prospectively examining the levels of cadmium, a toxic~     metal, and expression of genes required for normal sperm function. The semen and biopsies~     will be obtained during clinically dictated procedures. Cadmium and gene expression will be~     compared with response to varicocele repair (i.e., increased sperm production; pregnancy).~   "
270750|NCT00044356|"~     The purpose of this clinical trial is to determine if Allovectin-7®, an experimental~     gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this~     treatment can improve the time to disease progression.~   "
270751|NCT00044343|"~     The purpose of this study is to determine the efficacy of an oral investigational drug in~     patients with refractory metastatic colorectal cancer after receiving prior therapy with~     5-fluorouracil in combination with irinotecan and/or oxaliplatin.~   "
270752|NCT00044317|"~     This study was designed to follow a group of adolescents who were previously examined by~     questionnaire and pulmonary function tests when they were aged 8-10 years old. Approximately~     50% of the population in 10 towns were seen again at age 17-18. Questionnaires and pulmonary~     function were repeated. The hypotheses being tested related to whether the previously seen~     levels of pulmonary function that were related to pollution levels in the towns persisted as~     the lungs of these children grew and whether dietary antioxidants influences level of~     attained pulmonary function.~   "
270753|NCT00044291|"~     The purpose of this study is to determine whether the first line combination hormonal therapy~     of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is~     more effective than another approved drug, letrozole (Femara®), in delaying the growth of~     breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer,~     and whether the side effects of the combination are different from the side effects of~     letrozole.~   "
270754|NCT00044304|"~     The purpose of this study is to evaluate the safety and efficacy of the tyrosine kinase~     inhibitor, imatinib mesylate (Gleevec ) in reducing peripheral blood eosinophilia in patients~     with the myeloid form of hypereosinophilic syndrome (HES). Patients with the~     hypereosinophilic syndrome who meet a set of criteria designed to select patients with the~     myeloid form of the disease, as well as patients without myeloid disease who are refractory~     to standard therapy for HES, will be admitted on this protocol. A thorough clinical~     evaluation will be performed with emphasis on potential sequelae of eosinophil-mediated~     tissue damage. A baseline bone marrow will be obtained to exclude leukemia or lymphoma and to~     assess the degree and nature of eosinophilopoiesis. Bone marrow, blood cells and/or serum~     will also be collected to test for the presence of a recently described mutation that is~     associated with imatinib-responsiveness in HES, and to provide reagents (such as DNA, RNA,~     and specific antibodies) and for use in the laboratory to address issues related to the~     mechanism of action of imatinib mesylate in HES. Imatinib mesylate will be initiated at a~     dose of 400 mg daily, the FDA-approved dose for the treatment of chronic myelogenous~     leukemia. In patients who demonstrate a complete clinical and hematologic response to~     imatinib therapy and who do not have life-threatening disease, the dose will be decreased~     gradually to 100mg daily and then discontinued. In order to minimize bone marrow suppression,~     other myelosuppressive agents will be tapered and discontinued during the first week of~     therapy with imatinib mesylate. Complete blood counts will be performed weekly for the first~     month and biweekly thereafter. Clinical assessments will be performed every three months to~     assess progression of end organ damage.~      In patients who demonstrate a complete clinical and hematologic response to imatinib therapy~     and who do not have life-threatening disease, the dose will be decreased gradually to 100 mg~     daily and then discontinued. In the event of clinical, hematologic or molecular relapse~     during the taper, the imatinib dose will be increased to a maximum of 600 mg daily to achieve~     a second remission. Laboratory monitoring will be performed as above except for molecular~     monitoring which will be monitored monthly if drug is discontinued or molecular relapse~     occurs. Once a stable dosing regimen is achieved for greater than or equal to 6 months in~     subjects who have undergone dose descalation or greater than or equal to 2 years in subjects~     receiving 300-400 mg of imatinib daily who did not qualify for dose de-escalation, the~     frequency of NIH visits and end organ assessments will be decreased to 6 months, with~     molecular monitoring every 3 months and monthly routine laboratory assessments.~   "
270755|NCT00044278|"~     This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with~     partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age~     who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will~     be added to the subject's current epilepsy medications.~   "
270756|NCT00044265|"~     Ramipril is an ACE inhibitor that has been marketed in the US for the treatment of~     hypertension since 1991. It has been shown to be effective in reducing both systolic and~     diastolic blood pressure in adults when used once daily. ACE inhibitors are frequently used~     to treat hypertension in children, however ramipril has not been extensively tested in~     children, and information regarding the efficacy and safety would therefore be of benefit to~     children. This study is designed to demonstrate the efficacy and safety of ramipril in the~     treatment of hypertension in children ages 6 through 16 years.~   "
270757|NCT00044252|"~     This study will measure and compare hormone levels in women with catamenial epilepsy~     (epilepsy in which seizures are more frequent during menstrual periods), women with seizures~     not related to their menstrual cycle, and normal control subjects. It will determine whether~     there are differences among the three groups in their hormone levels or in how fast the~     levels change. It will also examine what relationship, if any, exists between hormone changes~     and seizures in women with catamenial epilepsy. The hormones under study include the gonadal~     hormones estrone, estradiol and progesterone, and the neuroactive steroids allopregnanolone,~     pregnenolone, and dehydroepiandrosterone.~      Women who meet the following criteria may be eligible for this 3-month study:~        -  Between 18 and 45 years of age, with catamenial epilepsy~        -  Between 18 and 45 years of age, with seizures, but not catamenial epilepsy~        -  Between 18 and 45 years of age, without seizures~      All participants will have a physical examination at the beginning of the study, at each~     clinic visit, and at completion or withdrawal from the study. In addition, they will undergo~     the following procedures:~      Baseline Monitoring~      For the first 2 months, all participants will keep a diary of their temperature and onset of~     menses. Women with epilepsy will also record their seizures.~      Electroencephalography (EEG)~      Healthy volunteers will have a 45-minute EEG (recording of the electrical activity of the~     brain) at the beginning of each menstrual cycle and each day during the menses. Women with~     epilepsy will have continuous EEG monitoring for 8 days, beginning 5 days before their~     menstrual period is expected. The continuous monitoring can be done on an outpatient basis,~     using a portable EEG recording device, or as an inpatient, with admission to the hospital for~     the 8 days of recording.~      Blood Sampling~      All participants will have a small blood sample (2 teaspoons) drawn once a day on days 10,~     14, 17, 19 and 21 of their menstrual cycle and three times a day on day 6 and for a period of~     8 days, starting 5 days before the expected menses and continuing for 3 days of the next~     cycle. For the days with three blood draws, a small needle that can stay in place for up to~     72 hours will be placed in the arm to avoid the discomfort of multiple needle sticks.~   "
270758|NCT00044239|"~     The purpose of this study is to learn more about Obsessive-compulsive Disorder (OCD) in~     children. OCD usually has a slow onset, and symptoms that may remain at a stable level over~     time. A subset of children with OCD has a sudden onset and symptoms that fluctuate in~     severity over time. This study will also compare healthy children to those with OCD. This is~     an observational study; children who participate will not receive any new or experimental~     therapies.~      OCD affects nearly 1% of the pediatric population. The symptoms of this illness can interrupt~     development, causing significant psychological distress and producing life-long impairments~     in social, academic, and occupational functioning. A subgroup of pediatric OCD has been~     designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated~     with Streptococcal Infections). This type of OCD is characterized by sudden symptom onset and~     a relapsing-remitting course of illness; exacerbation of symptoms occurs with scarlet fever~     or strep. throat infections. This study will identify factors that distinguish children with~     PANDAS OCD from children with non-PANDAS OCD, and will compare both groups to healthy~     children.~      Children with OCD and their parents are screened with interviews and a review of the child's~     medical records. Participants have an initial evaluation that includes a psychiatric,~     physical and neuromotor exam, neuropsychological testing, psychological interviews, and a~     blood test. Structural magnetic resonance imaging (MRS) scans of the brain are also obtained.~     The MRS scan does not use radiation.~      After the initial evaluation, children with OCD have follow-up visits every 6 weeks for 12 to~     24 months. They are seen yearly for 8 years after the study. If they have a significant~     improvement or worsening of their symptoms, they are asked to make a maximum of two extra~     visits. Parents of OCD patients are called four times a year to discuss any changes in the~     child's condition between yearly visits. All participants have a 1-year follow-up visit upon~     study completion.~   "
270759|NCT00044226|"~     Patients who are currently symptomatic and have been diagnosed with BPH by a physician may~     qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer~     and must not have had any surgery to repair your prostate or treat your BPH. Patients will~     first undergo a phone screening to confirm their eligibility and interest and to rule out any~     exclusionary history or medications. Eligible patients will be scheduled to come in to the~     clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a~     complete physical examination and history and answer several questionnaires to determine~     their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the~     clinic during this study.Qualified patients receive free study medication, free medical care~     (physical examinations, EKG, laboratory tests) for the duration of the study.~   "
270760|NCT00044213|"~     The purpose of this study is to determine the safety and effectiveness of ethylene diamine~     tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.~   "
270761|NCT00044187|"~     Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes~     with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of~     obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight~     gain that may be associated with taking olanzapine.~      The purposes of this study are to determine the safety of olanzapine when given in~     combination with the Anti-obesity Agent and any side effects that might be associated with it~     and whether weight-gain agent can help treat weight gain that may be associated with taking~     olanzapine.~   "
270762|NCT00044200|"~     This study uses positron emission tomography (PET) to examine brain function and signaling~     involving phospholipids, and to see how signaling is related to blood flow. Much of the brain~     is composed of fatty molecules called phospholipids. These molecules are involved in the way~     brain cells signal each other to direct brain function. Brain disease may change~     phospholipids and disturb brain structure and signaling. Studies of brain phospholipid~     composition and metabolism may help clarify how the brain works in healthy people or stops~     working effectively in disease states.~      Healthy volunteers between 18 and 45 years of age may be eligible for this study. Candidates~     are screened with a medical history, physical examination, and blood and urine tests.~     Participants undergo magnetic resonance imaging (MRI) and PET scanning as follows:~      MRI~      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For~     this procedure, the subject lies on a table that is moved into a metal cylinder (the scanner)~     and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning~     process. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45~     and 90 minutes. Subjects may be asked to lie still for up to 30 minutes at a time.~      PET~      For the PET scan, a catheter (thin plastic tube) is inserted into an artery in the subject's~     wrist or elbow crease to collect blood samples during the procedure, and a second catheter is~     placed in a vein in the opposite arm to inject radioactive tracers. The subject lies on the~     scanner bed, wearing a special facemask and goggles. The mask helps hold the head still~     during the scans, and the goggles either block all light or administer bright flashing~     lights. Radioactive water is injected into the vein, followed by a 1-minute PET scan to~     measure brain blood flow. This is repeated three more times. Then, a radioactive fatty acid~     is injected into the vein, followed by a 1-hour PET scan to measure brain phospholipid~     metabolism. This is repeated once. The images of blood flow and phospholipid metabolism in~     the different regions of the brain under the conditions of darkness and during visual~     stimulation provide information on how and where the brain responds to visual stimulation.~     The entire procedure takes about 3 hours.~   "
270763|NCT00044174|"~     This study will examine 1) differences among mothers behaviors and how these behaviors~     influence their infants reactions, and 2) how mother-child interactions relate to children s~     temperament, and cognitive (thought processing) abilities, and other areas of development.~      Depressed and non-depressed English-speaking mothers between 20 and 45 years of age, with an~     infant 4 months or younger, may be eligible for this study. Candidates will be screened with~     a mailed survey regarding their moods and feelings. Participants will undergo the following~     procedures:~        -  Psychiatric Interview: Subjects will participate in a 30-90 minute interview consisting~          of a series of standardized questions about the their behaviors and feelings.~          Participants whose interviews suggest a condition that may impact their mental health~          will be referred to the study clinician for follow-up to confirm or clarify the~          preliminary findings. Continued participation in the study will be determined following~          this.~        -  Home Visit: A study investigator will visit the home for 1 hour to film the mother and~          baby during the mother s typical daily activities. This visit will take place when the~          baby is about 5 months old. At the end of the visit, the mother will be given a variety~          of surveys to fill out at home and return at the next visit (see Lab Visit below). The~          survey questions deal with the mother s relationship with her partner, support from~          people in her life, typical behaviors of her infant, and how often she feels certain~          emotions. A packet of surveys will also be left for the participant s partner to~          complete and mail back to the investigator. The partner may or may not be the child s~          biological father and may or may not choose to participate in the study.~        -  Lab Visit: Within 1 week of the home visit, the mother and child will come to the NICHD~          clinic for about 2 hours. During this time, the mother will return the previous surveys~          and fill out another one regarding her current mood. She will then interact with her~          child, who will be seated in front of her. The 20-minute session will be videotaped.~          (There will be breaks during the session.) The mother will be instructed about how she~          should act (happy or sad). She and her baby will then participate in a variety of filmed~          situations that will induce certain emotions in the baby, such as happiness, fear,~          activity, frustration, and interest, in order to learn how different children react to~          different situations.~      Participants will be contacted to continue the study when their babies are 12 months old and~     again when the children are 24 months old. The above procedures will be repeated and some new~     measures will be added for toddlers that involve activities investigating aspects of early~     language and social reasoning..~   "
270764|NCT00044148|"~     The purpose of this study are to determine 1) Whether Ly333531 can reduce urinary~     albumin/creatinine excretion in patients with Type II diabetes and persistent albuminuria 2)~     Whether LY333531 reduces urinary TGF-B, 3) the safety of LY333531 and any side effects that~     may be associated with it.~   "
270765|NCT00044135|"~     The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment~     with clevudine, at one of three doses, in patients chronically infected with hepatitis B~     virus.~   "
270766|NCT00044070|"~     This study will investigate the effects of a potential neuroprotectant compound, YM872, in~     the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of~     YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured~     by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be~     determined by neurological function and disability scores at follow up visits through Day 90~     of the study.~   "
270767|NCT00044057|"~     The purpose of this study is to determine if YM872 in combination with t-PA can reduce~     disability and brain damage from stroke. YM872 or placebo will be given as a continuous~     intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or~     placebo, is administered prior to the completion of the t-PA administration. The clinical~     effects of YM872 in addition to t-PA will be determined by assessing neurological function~     and disability scores at follow up visits through Day 90 of the study.~   "
270768|NCT00044044|"~     The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a~     placebo and to haloperidol in patients with schizophrenia.~   "
270769|NCT00044031|"~     This study will test whether the G17DT Immunogen, when administered in combination with~     chemotherapy, is an effective and safe treatment for pancreatic cancer.~   "
270770|NCT00044018|"~     The purpose of the study is to select the dose regimen of CDC-501 that provides the most~     promising evidence of efficacy.~   "
270771|NCT00044005|"~     The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with~     schizophrenia.~   "
270772|NCT00043329|"~     The purpose of this study is to establish a registry of all children with severe, malignant~     osteopetrosis who are treated with Actimmune (IFN-g 1b or Interferon gamma-1b) to monitor the~     effects of IFN-g 1b on preventing progression of this disease and to follow the safety of~     patients receiving it on a long-term basis. In addition, evaluation of the possible effect of~     Actimmune therapy on the humoral response to normal childhood vaccinations in this same~     patient population will be examined.Interferon gamma is a substance that the body makes~     naturally.~   "
270784|NCT00043914|"~     This study includes patients 16 years of age or older with a confident diagnosis of epilepsy~     who are currently treated with an antiepileptic drug (AED) monotherapy but require a change~     in therapy due to inadequate seizure control and/or unacceptable side effects.~   "
270785|NCT00043901|"~     The purpose of this study is to evaluate the effectiveness and safety of an investigational~     new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC)~     seizures.~   "
270786|NCT00043875|"~     This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to~     the current therapy of pediatric patients age 1-24 months old with partial seizures. The~     medication used in this study has been approved by FDA for the adjunctive treatment of~     partial seizures in patients 2 years and older.~   "
271041|NCT00038584|"~     SCH66336 is a drug that has been designed to block the growth of tumor cells and encourage~     tumor cell death.~      This is a randomized study where patients will receive study drug or no drug. Participants in~     this study are scheduled to have surgery to remove head and neck cancer.~   "
270773|NCT00044122|"~     This study will examine growth factors that promote and inhibit mast cell proliferation~     resulting in mastocytosis, a disease of excessive mast cells in the body. These cells can~     release chemicals that cause itching, blisters, flushing, bone pain and abdominal pain.~      Patients up to 80 years of age with mastocytosis may be eligible for this 1-day study.~     Participants will have one visit at NIH lasting up to 8 hours, during which they will undergo~     the following tests and procedures:~        -  Medical history and physical examination.~        -  Laboratory studies, if medically indicated.~        -  Blood tests to identify genetic changes important in the growth, development, and~          functioning of mast cells.~        -  Bone marrow aspiration and biopsy.~      For the bone marrow procedure, the skin over the hipbone and the outer surface of the bone~     itself are numbed with local anesthesia. Then, a special needle is inserted into the hipbone~     and about 1 tablespoon of bone marrow is drawn into a syringe. Another needle is inserted~     into the same area to collect a small piece of the bone marrow. Additional procedures may~     include allergen testing, urinalysis, and 24-hour urine collection.~      Participants will receive an evaluation of their mastocytosis.~   "
270774|NCT00044109|"~     Despite much popularity among the public, magnetic devices used for the treatment of various~     musculoskeletal and neuropathic pain syndromes have been the subject of few randomized~     controlled trials.~      We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This~     study will include 52 men and women of all ethnic backgrounds between the ages of 28 and 75~     who have had signs and symptoms of sciatica for 3 months or more.~      This is a double-blind, randomized, placebo-control, two phase study. In the first phase,~     after one week baseline, subjects will be randomized to 4 different treatments in a~     cross-over design. These 4 treatments which will last two weeks each are: 1 magnetic device~     positioned in 2 different ways along the spinal axis (up-down along the lumbo-sacral spine~     and left-right across the lumbo-sacral spine), a sham device of similar configuration and a~     no treatment control. The length of phase I will be 8 weeks. At the end of this phase, codes~     will be broken to select the magnetic device associated with the greatest amount of pain~     score reduction. During the second phase which will also be double-blinded, subjects will be~     randomized to wear the selected magnetic device and sham in a cross-over design. Each of the~     2 periods will be 5 weeks in duration. The primary outcome measures will be the daily pain~     score in the leg. Daily pain level in the low back and the back and leg combined in addition~     to the patients' quality of life and activities of daily living will be secondary outcome~     measures as assessed by the SF 36, Oswestry, and Beck depression inventory.~   "
270775|NCT00044096|"~     The purpose of this study is to understand the effects of the drug alprazolam (Xanax ) on~     anxiety.~      To understand the effect of anxiety-relieving drugs on fear and anxiety, researchers often~     have participants anticipate unpleasant stimuli. Anticipating unpleasant stimuli increases or~     potentiates a simple reflex called the startle reflex. The so-called fear-potentiated startle~     reflex (FPS) effect may be blocked or reduced by anxiety-relieving drugs. Evidence suggests~     that the FPS can be mediated by two mechanisms that regulate the phasic- and sustained~     enhancement of startle. This study will elicit phasic and sustained FPS in participants by~     having them anticipate moderately painful stimuli that are administered predictably and~     unpredictably. The main goal of this study is to assess the affect of alprazolam on the~     phasic and sustained enhancement of startle.~      This study comprises two pilot experiments and a main study. Participants in the study will~     be screened with a psychiatric history, physical examination, electrocardiogram (EKG), and~     blood and urine tests. Participants will four testing sessions separated by 5 to 10 days. At~     each session, participants will be given one of two doses of alprazolam, diphenhydramine, or~     placebo (an inactive pill). Questionnaires and other tests will be performed.~   "
270776|NCT00044083|"~     This study will evaluate whether Tolcapone improves cognition in healthy volunteers as well~     as patients with schizophrenia. Talcapone is a drug that has been FDA approved for Attention~     Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the~     frontal cortex of the brain.~   "
270777|NCT00043992|"~     To examine the role of outdoor pollen grains and fungal spores in the exacerbation of asthma~     and to produce forecasting models to predict days of high concentration.~   "
270778|NCT00043966|"~     The purpose of this study is to compare the safety, tolerability and antiviral activity~     between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further~     characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.~   "
270779|NCT00043953|"~     The objectives of this study are to explore the metabolic toxicities associated with~     lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in~     antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of~     LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the~     pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in~     combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine~     BID.~   "
270780|NCT00043888|"~     Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study~     to test the safety and tolerability of fosamprenavir with or without ritonavir in combination~     TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.~   "
270781|NCT00043979|"~     This study will examine the safety and effectiveness of stem cell transplantation for~     treating patients with sarcomas (tumors of the bone, nerves, or soft tissue). Stem cells are~     immature cells in the bone marrow and blood stream that develop into blood cells. Stem cells~     transplanted from a healthy donor travel to the patient's bone marrow and begin producing~     normal cells. In patients with certain cancers, such as leukemia and lymphoma, the donor's~     immune cells attack the patient's cancer cells in what is called a graft-versus-tumor~     effect, contributing to cure of the disease. This study will determine whether this treatment~     can be used successfully to treat patients with sarcomas.~      Patients between 4 and 35 years of age with a sarcoma that has spread from the primary site~     or cannot be removed surgically, and for whom effective treatment is not available, may be~     eligible for this study. Candidates must have been diagnosed by the age of 30 at the time of~     enrollment. They must have a matched donor (usually a sibling). Participants undergo the~     following procedures:~      Donors: Stem cells are collected from the donor. To do this, the hormone granulocyte colony~     stimulating factor (G-CSF) is injected under the skin for several days to move stem cells out~     of the bone marrow into the bloodstream. Then, the cells are collected by apheresis. In this~     procedure the blood is drawn through a needle placed in one arm and pumped into a machine~     where the stem cells are separated out and removed. The rest of the blood is returned to the~     donor through a needle in the other arm.~      Patients: For patients who do not already have a central venous catheter (plastic tube), one~     is placed into a major vein. This tube can stay in the body the entire treatment period for~     giving medications, transfusing blood, , withdrawing blood samples, and delivering the~     donated stem cells. Before the transplant procedure, patients receive from one to three~     cycles of induction chemotherapy, with each cycle consisting of 5 days of fludarabine,~     cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone followed by at least a~     17-day rest period. All the drugs are infused through the catheter except prednisone, which~     is taken by mouth. After the induction therapy, the patient is admitted to the hospital for 5~     days of chemotherapy with high doses of cyclophosphamide, melphalan, and fludarabine. Two~     days later, the stem cells are infused. The anticipated hospital stay is about 3 weeks, but~     may be longer if complications arise. Patients are discharged when their white cell count is~     near normal, they have no fever or infection, they can take sufficient food and fluids by~     mouth, and they have no signs of serious graft-versus-host disease (GVHD)-a condition in~     which the donor's cells see the patient's cells as foreign and mount an immune response~     against them.~      After hospital discharge, patients are followed in the clinic at least once or twice weekly~     for a medical history, physical exam, and blood tests for 100 days. They receive medications~     to prevent infection and GVHD and, if needed, blood transfusions. If GVHD has not developed~     by about 120 days post transplant, patients receive additional white cells to boost the~     immune response. After 100 days, follow-up visits may be less frequent. Follow-up continues~     for at least 5 years. During the course of the study, patients undergo repeated medical~     evaluations, including blood tests and radiology studies, to check on the cancer and on any~     treatment side effects. On four occasions, white blood cells may be collected through~     apheresis to see if immune responses can be generated against the sarcomas treated in this~     study. Positron emission tomography (PET) scans may be done on five occasions. This test uses~     a radioactive material to produce images useful in detecting primary tumors and cancer that~     has spread.~   "
270782|NCT00043940|"~     Primary Objective:~      To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with~     new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and~     thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will be~     measured by the composite incidence of major bleeding events during administration or within~     48 hours after stopping bivalirudin (or at hospital discharge, whichever occurs first). The~     components of the composite endpoint are: a) intracranial bleeding; b) retroperitoneal~     bleeding; c) bleeding that results in hemodynamic compromise; d) bleeding that requires~     transfusion of three or more units of whole blood or packed red cells; and e) a decrease in~     hemoglobin of greater than or equal to g/dL or in hematocrit of greater than or equal to 9%.~      Secondary Objectives:~      Each component of the primary composite endpoint.~      To evaluate the level of anticoagulation achieved with bivalirudin. The goal is to achieve an~     activated clotting time (ACT) between 300 and 350 sec during PCI and 4-hour bivalirudin~     infusion.~      To evaluate bivalirudin's effects on platelet counts.~   "
270787|NCT00043862|"~     This study will gather information on the effectiveness and safety of a treatment program for~     small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation~     therapy, and an oral investigational drug that may enhance the effects of radiation therapy.~     Study patients will receive two additional courses of the standard chemotherapy combination~     after completing radiation therapy.~   "
270788|NCT00043849|"~     The primary aim of this study is to determine the safety and efficacy of quetiapine~     (Seroquel) for the treatment of psychosis and/or agitation in patients with primary dementia~     complicated by coexistent parkinsonism, or patients with Parkinson's disease with dementia~     [PDD] who have episodes of agitation or psychosis. The secondary aim is to determine the~     safety and tolerability, particularly the influence on parkinsonism, of quetiapine when used~     to treat psychosis and/or agitation in patients with dementia complicated by coexistent~     parkinsonism.~   "
270789|NCT00043836|"~     The purpose of this study is to test the hypothesis that treatment with oral ALT-711 twice~     daily for 16 weeks will improve aortic distensibility, exercise tolerance, and quality of~     life in elderly patients with isolated diastolic heart failure (DHF), and that the~     improvements in exercise tolerance will correlate with the improvements in aortic~     distensibility.~   "
270790|NCT00043823|"~     Primary Objectives:~        1. (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the~          combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced~          Non-small-cell lung carcinoma (NSCLC).~        2. (Phase II) To assess response rate and tolerability of the regimen at the dose level~          established in the phase I portion of this study.~      Secondary Objectives:~        1. (Phase I and II) To evaluate the pharmacokinetic interaction between the combination.~        2. (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for~          further study alone or in combination with cytotoxic chemotherapy.~   "
270791|NCT00043810|"~     Patients with Acute Myelogenous Leukemia or Myelodysplastic are able to achieve a complete~     remission but fail to achieve a prolonged disease-free survival. High dose chemotherapy and~     autologous bone marrow transplantation has been shown to be effective in this group of~     patients but hematopoietic recovery is slow, and infectious or bleeding complications are~     common. The delay in hematopoietic recover is accentuated by the use of purging techniques.~     This is a novel purging approach for autologous stem cell transplantation in patients with~     Acute Myelogenous Leukemia or Myelodysplastic syndrome to allow for rapid engraftment with a~     lower relapse rate therefore improving the therapeutic outcomes~   "
270792|NCT00043797|"~     This clinical trial is to determine an effective dosage and to study the safety of an~     investigational drug -lidorestat (IDD-676)- which is intended to stop or slow the progression~     of diabetic peripheral neuropathy.~   "
270793|NCT00043784|"~     Patients experiencing a mild heart attack will receive one of two medications which thin the~     blood to discern which is superior.~   "
270794|NCT00043693|"~     This study will evaluate a family intervention program for individuals with bipolar disorder,~     schizophrenia, or schizoaffective disorder and co-occurring substance use disorders.~   "
270795|NCT00043771|"~     Patients with congestive heart failure will be assessed for safety and clinical effects of~     Tolvaptan 30 mg every day versus 15 mg twice a day over a period of 7 days.~   "
270796|NCT00043758|"~     The purpose of this study is to study the effects of tolvaptan on the size and function of~     the left heart chamber (ventricle) in patients with congestive heart failure (CHF)~   "
270797|NCT00043745|"~     This study will provide valuable data on whether soy isoflavones impact bone loss in~     postmenopausal women. The study will help clarify potential mechanisms and contribute to our~     understanding of isoflavones as an alternative to traditional hormone therapy.~   "
270798|NCT00043732|"~     The main objective of the study is to evaluate the safety and tolerability of six escalating~     doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit~     p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis~     factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which~     are known to contribute to both symptoms and disease progression in patients with Rheumatoid~     Arthritis.~   "
270799|NCT00043719|"~     Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time.~     The purpose of this study is to determine the safety and effectiveness of nitroglycerin~     ointment for the treatment of osteopenia in postmenopausal women.~      Study hypothesis: On average, participants in the base therapy cohort who receive placebo~     ointment control and calcium/vitamin D will lose more bone density than participants in the~     nitroglycerin cohort over the 36-month period.~   "
270800|NCT00043706|"~     Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the~     connective tissue generally classified as one of the rheumatic diseases. Systemic Sclerosis~     causes fibrosis (scar tissue) to be formed in the skin and internal organs. The fibrosis~     eventually causes the involved skin to harden, limiting mobility, and can also damage other~     organs. Excess Transforming Growth Factor Beta-1 (TGF-beta1) activity may result in the~     abnormal fibrosis characteristic of Systemic Sclerosis. An antibody against TGF-beta1 may~     modify pathologic processes characterized by inappropriate fibrosis. Genzyme Corporation is~     currently investigating a human monoclonal antibody (CAT-192) that neutralizes active~     TGF-beta1. This study is being conducted in the U.S. and Europe to evaluate the safety,~     tolerability, and pharmacokinetics of repeated treatments with CAT-192 in patients with early~     stage diffuse Systemic Sclerosis.~   "
270801|NCT00043602|"~     This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal~     Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard~     IPT.~   "
270802|NCT00043589|"~     This study will evaluate the effectiveness of donepezil (Aricept®) and cognitive training in~     improving memory performance in elderly adults.~   "
270803|NCT00043576|"~     The purposes of this study are to determine if DN-101 plus Taxotere lowers PSA levels, delays~     or limits disease progression and is safe with minimal side effects.~   "
270804|NCT00043680|"~     This study will determine whether the drug celecoxib (Celebrex® (Registered Trademark)) can~     help stabilize or improve vision in patients with age-related macular degeneration (AMD) who~     are receiving photodynamic therapy, or PDT (also called cold laser treatment). The macula is~     the part of the retina in the back of the eye that determines central or best vision. AMD can~     severely impair central vision, affecting a person's ability to read, drive, and carry out~     daily activities. This vision loss is caused by the formation of abnormal new blood vessels~     in the choroid-a thin, pigmented vascular layer of the eye behind the retina-that leak blood~     under the macula. PTD stops the growth of these blood vessels and slows the rate of vision~     loss. However, the treatment usually does not cause vision to improve, and it has only a~     temporary effect, requiring several treatments over 2 years. Furthermore, PDT does not work~     in all patients and may actually cause some swelling and re-growth of blood vessels.~     Celecoxib is an anti-inflammatory drug that, in animal studies, has prevented the growth of~     abnormal blood vessels associated with tumors and with injury to the cornea. Thus, the drug~     might reduce swelling and prevent vessel re-growth in AMD, enhancing the effectiveness of~     PDT.~      Patients 55 years of age and older with AMD and visual acuity of 20/20 to 20/200 may be~     eligible for this study. Participants will be randomly assigned to take either celecoxib or a~     placebo (a look-alike pill with no active drug) twice a day and undergo the various tests and~     procedures detailed below. Not every examination will be done at every visit, but all may be~     required at one visit.~        -  Medical history and physical examination~        -  Blood drawing: A blood sample is drawn from an arm vein to evaluate liver and kidney~          function~        -  Eye examination: Visual acuity and eye pressure are measured, and the lens, retina,~          pupils and eye movements are examined~        -  Photography: Photographs of the eye are taken using a special camera with a bright flash~        -  Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood~          vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in~          the eyes. The retina is photographed using a camera that flashes a blue light into the~          eye. The pictures show if any dye has leaked from the vessels into the retina,~          indicating possible blood vessel abnormality.~        -  Indocyanine green angiography: This procedure, similar to fluorescein angiography, uses~          a green dye to photograph the retina and identify portions of abnormal vessels in the~          deepest part of the retina.~        -  Optical coherence tomography: This new technique uses light to produce a 2-dimensional~          cross-sectional picture of the retina. The patient looks into a machine called an~          optical coherence tomograph at a pattern of flashing and rotating red and green lights,~          first with one eye and then the other.~      One week after starting the study medications, laser treatment will begin. For this~     procedure, a needle is placed in an arm vein and a chemical called verteporfin (Visudyne®~     (Registered Trademark)) is infused into the vein over 10 minutes. After 15 minutes, the eye~     is anesthetized with numbing drops. A special contact lens is then placed on the eye and the~     laser beam is directed to the eye for 83 seconds.~      Patients will be followed in the clinic every 6 weeks for 36 weeks for various examinations~     and possible re-treatment, if needed. Some patients will be asked to return 1 to 2 weeks~     after the first PDT for an eye examination and fluorescein angiography.~   "
270805|NCT00043667|"~     This study will examine the safety and effectiveness of a monoclonal antibody called~     daclizumab in treating uveitis, an eye inflammation. Monoclonal antibodies are genetically~     engineered proteins made in large quantities and directed against a specific target in the~     body. Daclizumab is designed to prevent a specific chemical interaction needed for immune~     cells called lymphocytes to produce inflammation. In an ongoing NIH study of 10 adults with~     uveitis, 8 patients were able to decrease corticosteroids and other immunosuppressive~     medicines they were taking while receiving daclizumab for months or even years. The study~     will be conducted at three different sites, including the NIH Clinical Center.~      Patients 6 years of age and older with non-infectious uveitis of at least 3 months' duration~     who require treatment with immune suppressing medicines, such as prednisone,~     cyclophosphamide, cyclosporine, azathioprine, methotrexate, or others, may be eligible for~     this study. Candidates will be screened with a medical history and physical examination,~     blood tests, complete eye examination, and a questionnaire about the patient's vision and~     daily activities.~      Participants will come to the study center every 2 weeks for treatment and evaluation.~     Daclizumab treatments are given by injection under the skin, usually in the arm. Patients~     will receive a maximum of 28 treatments over a 1-year period. Treatment may be extended for a~     few months while other participants reach their 1-year mark. The first two induction~     treatments are at a higher dose (2 mg/kg of body weight) than the maintenance dose of 1~     mg/kg. After the first daclizumab treatment, other uveitis medications will be tapered, one~     at a time. If the disease remains quiet, these drugs may eventually be stopped completely.~      For the first 6 months, all patients will receive daclizumab injections and evaluations every~     2 weeks. After that, if other medications have been reduced and vision has remained stable,~     treatments and evaluations may be spread out to every 3 or 4 weeks. Over time, fewer tests~     may be required during the biweekly examinations if the patient is doing well, but nearly all~     the examinations done at screening will be repeated at 3-month intervals. If inflammation or~     vision loss occurs during drug tapering, appropriate treatment will be administered. If the~     vision loss is too great, the patient will be treated with steroids or other medicines and~     taken off the study.~      Additional, special tests done at selected study centers include the following:~        -  Fluorescein angiography: This test is done to check for abnormalities of eye blood~          vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in~          the eyes. Pictures of the retina are taken with a special camera that flashes a blue~          light into the eye. The pictures show if any dye has leaked from the vessels into the~          retina, indicating possible abnormalities.~        -  Pelvic ultrasound and urine test: These tests are done at enrollment and after 1 year to~          check the kidneys, lymph nodes, and pelvic area.~        -  Blood tests: Additional blood tests are done at enrollment and every 3 to 6 months for~          laboratory and immunology study.~   "
271042|NCT00038571|"~     Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of~     bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.~   "
270806|NCT00043654|"~     Bipolar Depression is a severe illness with high rates of psychiatric comorbidity and~     increased mortality related to suicide and medical illness. Hypothalamic pituitary axis (HPA)~     hyperactivity are found in bipolar disorder related to depression and mixed states. Patients~     with bipolar disorder also have cognitive difficulties and endocrine disturbances may~     contribute to such dysfunction. Antiglucorticoid therapies are novel treatments of mood~     disorder. Preliminary data in psychotic depression suggesting that mifepristone (RU-486), a~     glucocorticoid receptor antagonist, has antidepressant and salutary cognitive effects in a~     matter of days. In this study we examine the effects of mifepristone in severe bipolar~     depression in a parallel, double blind placebo controlled experiment. Bipolar subjects~     maintained on either lithium or valproate, after washout or prior antidepressants have a~     detailed neuroendocrine assessment. Patients approximately or almost 75 will receive eight~     days of mifepristone versus placebo after which patients are blindly crossed over to the~     opposite arm. Patients and a group of matched controls approximately or almost 35 will be~     compared with neuroendocrine, cognitive, and neurophysiologic testing to fully characterize~     their phenotype and explore biomarkers of response. It is hypothesized that stigmata of HPA~     axis hyperactivity and cognitive impairment will be predictive of response to~     antiglucocorticoid therapy with mifepristone.~   "
270807|NCT00043641|"~     This study will investigate low-level viral loads in HIV-infected patients taking highly~     active antiretroviral therapy (HAART). Although HAART reduces viral levels and restores~     immune function to some degree, it does not cure HIV infection. The virus persists even at~     levels below that which it can be detected. This study will examine where this residual virus~     comes from in order to better understand the infection and the effectiveness of therapies. In~     addition, the study will 1) evaluate the ability of a new test to detect the virus at low~     levels; and 2) determine whether adding the protease inhibitor Kaletra to the HAART treatment~     regimen for patients with a low viral load will further decrease their viral load.~      HIV-infected patients 18 years of age and older may be eligible for this study. Patients~     involved in the viral load test will be recruited from an NIAID HIV study in which they are~     already participating. Three groups of patients will be enrolled: those with a viral load of~     less than 50 copies/ml plasma, those with 51-500 copies/ml, and those with 501-5000~     copies/ml. Patients involved in the Kaletra trial must have been taking HAART for 6 months or~     more and have less than 50 viral copies/ml plasma. They will be screened for this study with~     a history, physical examination, and routine laboratory tests.~      Participants in the viral load test evaluation will donate 70 ml of blood up to four times.~     No more than one sample will be collected per day.~      Participants in the Kaletra trial will have blood samples drawn on two successive days and~     will then be randomly assigned to one of two treatment groups. One group will begin Kaletra~     therapy (four capsules two times a day) immediately; the other will undergo observation for 4~     weeks before starting Kaletra. Depending on what group they are in, patients will provide~     blood samples for viral load measurements and clinical samples according to the following~     schedule:~      Immediate Kaletra~      One sample each during weeks 1, 2, and 3, of therapy and two samples during week 4.~      Delayed Kaletra~      One sample each during weeks 1, 2, and 3 of observation and two samples during week 4. After~     starting therapy, one sample will be collected each week during weeks 1, 2, and 3 of therapy~     and two samples during week 4.~      In both groups, after the last dose of medicine on day 28, Kaletra therapy will be complete.~     At the end of therapy, additional blood will be collected for viral sampling as follows: one~     sample each during weeks 1, 2, and 3, and two samples during week 4 after Kaletra therapy.~   "
270808|NCT00043628|"~     This two-part study will determine whether stem cells (primitive cells produced by the bone~     marrow that can develop into blood cells or other types of cells) can be pushed out into the~     bloodstream, relocate in the heart, and grow new heart muscle and blood vessels in patients~     with chest pain caused by narrowing of their coronary (heart) arteries. The new blood vessels~     may enable patients to do more activities before experiencing chest pain. Part 1 of the study~     will evaluate in a small number of patients whether an increase in white blood cells~     following administration of G-CSF (a drug used to move stem cells from the bone marrow to the~     bloodstream) is safe in people with coronary heart disease. Part 2 will evaluate the effects~     of the circulating stem cells on heart function.~      Patients 21 years of age and older with coronary artery blockage that limits blood flow to~     the heart (as shown by coronary angiography within 6 months of entering the study) and causes~     chest pain that interferes with the ability to carry out daily living activities may be~     eligible for this study. Candidates will be screened with blood tests, an exercise test,~     magnetic resonance imaging (MRI), and 24-hour Holter monitoring of heart rate and rhythm.~     Participants will undergo the following tests and procedures:~      Part 1: Patients will be hospitalized at the NIH Clinical Center for 5 days. On the first day~     after admission, an indwelling catheter (short plastic tube) will be placed in an arm vein to~     avoid multiple needle sticks for blood sampling. Patients will then exercise on a treadmill.~     Blood samples will be drawn before the exercise test and 2 hours after the test. The next 2~     days, patients will receive a daily injection of G-CSF under the skin. Blood samples will be~     drawn every day for 5 days to monitor the effect of G-CSF on moving cells into the~     bloodstream. Additional samples will be drawn to determine the effects of G-CSF on the number~     of stem cells that become heart cells, as well as any effects on blood clotting ability.~     After discharge for the hospital, patients will return to the clinic 2 weeks after the~     initiation of G-CSF treatment for a physical examination, blood tests, and a treadmill~     exercise test. One month after the initiation of treatment, patients will return to the~     clinic for a physical examination, blood tests, treadmill exercise test, an MRI study, and~     fitting with a Holter monitor for 24-hour heart monitoring.~      Part 2: Patients will be hospitalized at the NIH Clinical Center for 5 days, undergoing the~     same procedures as in Part 1, except they will receive G-CSF for 5 days instead of 2. They~     will also undergo the same procedures detailed for the 2-week and 1-month follow-up visits.~     Then, at 3 months they will again return to the clinic for a physical examination, routine~     blood tests, and a treadmill exercise test. This concludes formal participation in the study.~     However, patients are requested to return to the outpatient clinic once a year for follow-up.~   "
270809|NCT00043615|"~     This study will collect biological samples-blood, bone marrow, tumor or other tissue~     samples-for use in cancer-related research. The specimens will be used for various tests of~     drug resistance, blood vessel formation, cancer-causing proteins and immune functions. The~     purpose is to identify steps in the cancer development process that may serve as targets for~     treatment and to test various therapies for current and future cancer treatment clinical~     trials.~      Individuals 18 years of age and older with cancer or a pre-cancerous condition, such as colon~     polyps or cervical dysplasia, are eligible for this study, as are patients at high risk for~     cancer. In addition, patients who do not have cancer but require surgery, biopsy or other~     procedure for another medical reason may be included as normal specimen donors.~      Participants will have about 40 milliliters (3 tablespoons) of blood drawn upon entering the~     study and additional 40-ml samples drawn periodically during the course of treatment. No more~     than 120 ml of blood will be drawn over a 12-month period. Some patients may require a~     surgical procedure or biopsy (removal of tumor tissue) for medical reasons or as part of~     their enrollment in a research treatment study. In such cases, a portion of the specimens~     collected during those procedures will be used for the research studies in this protocol.~   "
270810|NCT00043563|"~     This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal~     attention control (AC) condition for treatment of pediatric trichotillomania (TTM).~   "
270811|NCT00043550|"~     This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®),~     venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which~     is more effective in treating major depression.~   "
270812|NCT00043537|"~     This 4-year study will compare the long-term effectiveness of behavioral treatment,~     fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.~   "
270862|NCT00042341|"~     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the~     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia~     (ALL) who have had at least 2 prior treatment regimens.~      The purpose of this study is to determine whether Clofarabine is safe and effective in the~     treatment of Acute Lymphoblastic Leukemia (ALL.)~   "
270863|NCT00042328|"~     The purpose of this research is to study the pharmacology (how the body handles this drug) of~     valacyclovir in children receiving treatment for cancer. This study will last approximately 7~     days.~   "
270813|NCT00043511|"~     The purpose of this study is to see if the experimental HIV vaccine pGA2/JS2 is safe and is~     well tolerated at two different doses. Another important purpose of this study is to observe~     how the immune system responds to the vaccine at different dose levels.~      Vaccines are given to people to help their bodies fight infection. The vaccine being tested~     in this study is a DNA vaccine. The pGA2/JS2 plasmid DNA vaccine instructs the body to make~     some HIV proteins. These HIV proteins may trigger an immune response. Because only a few of~     the many proteins HIV needs are made through DNA vaccination, there is no risk of getting HIV~     from the vaccination. This and other similar DNA vaccines have been tested for safety in~     mice, rabbits, and monkeys. The vaccine has been well tolerated at doses to be used in this~     study.~   "
270814|NCT00043498|"~     A molecular epidemiologic study of African American and Hispanic mothers and newborns to~     investigate the role of common urban pollutants on procarcinogenic and developmental damage.~   "
270815|NCT00043459|"~     The purpose of the study is to determine whether T900607-sodium is effective and safe in~     treating non-Hodgkin's lymphoma.~   "
270816|NCT00043446|"~     The purpose of this study is to determine whether T900607-sodium is effective and safe in~     treating ovarian cancer.~   "
270817|NCT00043433|"~     The purpose of the study is to determine whether T900607-sodium is effective and safe in~     treating hepatocellular carcinoma, a type of liver cancer.~   "
270818|NCT00043420|"~     To assess the effect of CPG 7909 Injection on Cutaneous T-cell lymphoma and the safety of CPG~     7909 Injection in patients with this cancer.~   "
270819|NCT00043407|"~     CPG 7909 given alone to patients with renal cell cancer after their nephrectomy. CPG 7909 is~     as a subcutaneous injection once per week for up to 24 weeks. Up to 40 patients will be~     included in the study.~   "
270820|NCT00043394|"~     To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients~     with metastatic breast cancer.~   "
270821|NCT00043381|"~     To compare the safety and efficacy profiles of decitabine to those of supportive care in~     adults with advanced-stage myelodysplastic syndrome (MDS)~   "
270822|NCT00043368|"~     This protocol allows patients who completed Coley oncology studies using PF-3512676 (CPG~     7909) Injection to continue receiving the treatment until disease progression.~   "
270823|NCT00043355|"~     The purpose of this research study is to test the safety and effectiveness of inhaled~     Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral~     antibiotics which may be administered for up to 72 weeks for the treatment of a lung~     infection caused by a bacterium called Mycobacterium avium complex .~      FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs,~     which is the purpose of this study.Interferon gamma-1b and similar proteins play important~     roles in establishing and maintaining protective immune responses against a variety of~     microorganisms.~   "
270824|NCT00043342|"~     The purpose of this research study is to evaluate the safety, tolerability, and efficacy of~     Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period~     of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary~     assessments on the effects of IFN-gamma 1b on lung function and other indicators of health~     will be made.~   "
270825|NCT00043472|"~     This study will evaluate women who are at increased genetic risk of developing ovarian cancer~     because they or a close relative have a mutation in the BRCA1 or BRCA2 gene (the genes that~     cause most of the genetic forms of ovarian cancer) or because they have a very strong family~     history of breast and/or ovarian cancer. The study has two aspects. There will be two groups~     of subjects in this study. One group of women who will have their ovaries and fallopian tubes~     surgically removed as a prophylactic (preventive) measure against developing~     ovarian/fallopian tube cancer. These women will be studied to determine whether the surgery~     does, in fact, decrease the risk of ovarian or tubal cancer and whether it decreases the risk~     of breast and other cancers. The tissue removed at surgery will also be investigated to see~     whether a new way of examining the ovaries after they are removed provides better information~     about cancer-related tissue changes. A second group of subjects will be women who choose not~     to have preventive surgery. These women will be followed closely to see if screening with~     multiple CA-125 blood testing over time (see below) can detect ovarian or tubal cancers in~     their early stages. Both groups of women will undergo examination of the process by which~     women decide upon various options for lowering their ovarian cancer risk and a detailed~     assessment of how their choice impacts their quality of life. It will look at how those who~     opt for ovariectomy feel after their surgery and how those who choose screening feel during~     the time of screening.~      All participants will undergo the following procedures:~        -  Medical history, physical examination, and blood drawing upon entering the study,~          including blood samples for future ovarian cancer research.~        -  Screening mammogram, CA-125 blood test, and transvaginal ultrasound upon entering the~          study, with yearly repeat mammograms for all participants and yearly transvaginal~          ultrasound exams for women in the screening arm of the study. CA-125 is a protein found~          in the blood whose levels are elevated in most women with ovarian cancer. Transvaginal~          ultrasound is a way of taking pictures of the ovaries using sound waves. If the results~          of these tests are not normal, additional tests may be required to learn the reason for~          the abnormality.~        -  Questionnaires about personal, medical and family history, ovarian cancer risk factors,~          medication use, medical choices, and quality of life on entering the study, with repeat~          quality of life and medication use questionnaires every 6 months during the study~          period.~        -  Blood samples for follow-up visits and for CA-125 testing every 3 months as a screen for~          ovarian/fallopian tube cancers. Some blood from these samples will be saved for future~          ovarian cancer research.~        -  Semi-annual report during the duration of the study regarding health and quality of life~          changes that occur over the prior 6-month period.~      Researchers will use the pattern and rate of change of CA-125 levels over time in women in~     the screening group to decide if more tests are needed to test for ovarian cancer. Women in~     the surgery portion will undergo surgical removal of their ovaries and fallopian tubes. The~     removed tissues will be studied using new methods to examine the cells more closely than~     usual, and a portion of the tissues will be stored for future research on ovarian cancer.~     This study is being conducted in collaboration with the Gynecologic Oncology Group (GOG), and~     is designated GOG Protocol 0199. Subjects may join the study at any participating GOG~     institution (http://www.gog.org).~   "
270826|NCT00043316|"~     The purpose of this research study is to evaluate the safety and effectiveness of Interferon~     gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by~     inhalation (breathed into the lungs) three times a week for 12 weeks.~      The FDA has not approved Interferon gamma-1b for use with cystic fibrosis patients, which is~     the condition being examined in this study.~   "
270827|NCT00043303|"~     The purpose of this research study is to test the safety and effectiveness of Interferon~     gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced~     liver fibrosis and cirrhosis in patients with chronic hepatitis C infections.~      IFN-g 1b is not currently approved for the treatment of liver fibrosis.~   "
270828|NCT00043277|"~     The goals of this study are:~        1. To assess the safety of bivalirudin in infants under six months with arterial or venous~          thrombosis;~        2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as~          measured by the activated clotting time (ACT) or activated partial thromboplastin time~          (aPTT) in Infants Under Six Months with arterial or venous thrombosis;~        3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution~          and bleeding complications compared to patients on unfractionated heparin (UH) or low~          molecular weight heparin (LMWH).~   "
270829|NCT00043264|"~     Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central~     nervous system (CNS). The etiology of MS is unknown, although the immune system appears to~     play a role. Many different infectious agents have been proposed as potential causes for MS,~     including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at~     Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS~     of MS patients. These findings have been replicated in part by other laboratories.~      The purpose of the current study is to test whether antibiotic treatment aimed at eradicating~     Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will~     be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into~     the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal~     fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these~     criteria will be randomized to either placebo or antibiotic therapy, and followed for 6~     months on treatment.~   "
270830|NCT00043238|"~     This study will determine the pathways between Mohawk cultural identification and specific~     behaviors related to pollutant exposure, and determine the effects of these factors and the~     pollutant exposure on physiologically and socially significant outcomes.~   "
270831|NCT00043212|"~     The purpose of this clinical research study is to assess the safety and efficacy of an~     investigational therapy called DCVax(TM)-Prostate.~   "
270832|NCT00043199|"~     To determine the rate of response and duration of reponse following therapy with Aroplatin in~     subjects with advanced colorectal cancer resistant to standard therapies. Secondary~     objectives are to determine safety and tolerability of the Aroplatin therapy.~   "
270878|NCT00042159|"~     This study will evaluate the long-term effects of repetitive transcranial magnetic~     stimulation (rTMS) in patients with auditory hallucinations.~   "
270833|NCT00043225|"~     This study will examine 1) the role of hereditary factors in cystic fibrosis; i.e., the~     relationship of the disease to specific gene variations, and 2) the role of bacterial~     products involved in lung infections substances produced by bacteria may worsen the disease.~      Patients with cystic fibrosis who are being followed by the Medical College of Wisconsin or~     the University of Wisconsin-Madison are eligible for this study. Participants will have blood~     tests, pulmonary function tests, a sputum culture, and buccal swabbing (cotton swabbing of~     the inside of the cheek to collect cells for DNA study). In addition, their medical records~     will be reviewed for a history of lung infections and the results of various tests, including~     pulmonary function studies, chest X-rays and bacterial cultures. Blood samples collected~     previously at the Medical College of Wisconsin or the University of Wisconsin-Madison will~     also be analyzed for antibodies to bacteria.~      Although this is a one-time study, participants may be asked to return for repeated tests.~   "
270834|NCT00043186|"~     To determine the effect of denosumab treatment compared with placebo over 12 months on bone~     mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical~     hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12~     months will significantly increase lumbar spine bone mineral density and will be well~     tolerated.~   "
270835|NCT00042718|"~     The purpose of this study is to evaluate the safety and effectiveness of four oral antibiotic~     treatment regimens for bacterial infections in patients with chronic bronchitis. The study~     goals are to demonstrate that 1) levofloxacin 750 mg once daily for three days is no worse~     than azithromycin 250 mg twice a day for one day and then 250 mg once a day for four more~     days, and 2) levofloxacin 750 mg once daily for five days is no worse than amoxicillin/~     clavulanate (875/125 mg) twice daily for 10 days.~   "
270836|NCT00042705|"~     This study measures residential exposures (indoor allergens, mold, nitrogen dioxide,~     nicotine) and relates exposure levels to daily symptoms (wheeze, persistent cough, chest~     tightness, shortness of breath) and medication use, in a population of children with~     physician diagnosed asthma, followed for 12 months.~   "
270837|NCT00042692|"~     The goal of the clinical trial aim in this project is to test whether catechol thioethers can~     be used as biomarkers of dopaminergic neurodegeneration.~   "
270838|NCT00042679|"~     The purposes of this study are to determine the following:~      Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear,~     and for how long.~      If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer.~      The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be~     associated with the combination of these three drugs.~      How LY900003 is distributed and broken down by your body when it is given with carboplatin~     and gemcitabine.~      Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down~     by your body.~   "
270839|NCT00042666|"~     This study will measure the effectiveness and any side effects of LY317615 in patients with~     Diffuse large B-cell lymphoma (a sub-type of Non-Hodgkins Lymphoma).~   "
270840|NCT00042653|"~     This 6 month study will assess an investigational medication for patients on dialysis with~     secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone,~     calcium and phosphorus levels.~   "
270841|NCT00042601|"~     This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over~     study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and~     obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.~   "
270842|NCT00042588|"~     The objective of this study is to demonstrate the safety and efficacy of IC14 in the~     treatment of hospitalized patients with community-acquired pneumonia and sepsis.~   "
270843|NCT00042575|"~     The Purposes of this Study are to determine:~      The safety of duloxetine and any side effects that might be associated with it.~      Whether duloxetine can help patients with major depression.~      It is possible that information collected during this study will be analyzed by the sponsor~     in the future to evaluate duloxetine for other possible uses or for other medical or~     scientific purposes other than those currently proposed.~      Duloxetine might not have any good effects for you.~   "
270844|NCT00042562|"~     The purposes of this study are to determine:~      The safety of duloxetine and any side effects that might be associated with it.~      Whether duloxetine can help patients with major depression.~      The safety associated with switching from a medication you may be taking for depression to~     taking duloxetine.~      It is possible that information collected during this study will be analyzed by the sponsor~     in the future to evaluate duloxetine for other possible uses or for other medical or~     scientific purposes other than those currently proposed.~   "
270845|NCT00042549|"~     The purpose of this study is to determine the effectiveness and safety of using the Medstone~     lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.~   "
270846|NCT00042627|"~     This study will investigate whether people who donate granulocytes (a type of white blood~     cell) by leukapheresis are at increased risk of developing cataracts (changes in the lens of~     the eye that can impair vision). Apheresis is a method of collecting large numbers of white~     blood cells. The procedure is similar to donating whole blood, but the collected blood is~     circulated through a cell separator machine, the white cells are extracted, and the rest of~     the blood is returned to the donor. Before the procedure, donors are given a steroid called~     dexamethasone. This drug temporarily increases the number of granulocytes circulating in the~     blood, thus allowing twice as many of these cells to be collected.~      Recently, one blood collection center reported greater numbers of cataracts in a small number~     of granulocyte donors who had received repeated doses of steroids for granulocyte~     mobilization. The donors were unaware that they had the cataracts, which were small and did~     not affect their vision. Although people who take high doses of steroids over a long period~     time are known to have an increased risk of cataracts, steroids given infrequently (and in~     the doses used for granulocyte donation) have not been associated with cataracts. This study~     will examine the eyes of granulocyte donors and of platelet donors. Platelets-blood~     components necessary for clotting-are also collected by pheresis, but donors are not given~     steroids before the procedure. The examination findings will be compared to see if there is a~     difference in the risk of cataract formation in the two groups.~      People 18 years of age and older who have donated granulocytes or platelets at the NIH~     Department of Transfusion Medicine four times or more since 1984 may be eligible for this~     study. Participants will undergo the following procedures:~        -  Detailed medical history, including allergies, corticosteroid use, diabetes mellitus,~          and asthma~        -  Detailed eye history, including cataracts, glaucoma, other eye diseases and infections,~          eye trauma, and corrective lenses~        -  Detailed history of sun exposure~        -  Eye examination, including measurement of visual acuity (eye chart test) and eye~          pressure, examination of the lens and retina.~        -  Photographs of the eye using a special camera~   "
270879|NCT00042146|"~     This study will evaluate the long- and short-term effects of cognitive-behavior therapy~     (CBT), alone and in combination with zolpidem (Ambien®), for chronic insomnia.~   "
271043|NCT00038558|"~     Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD~     chemotherapy.~   "
270847|NCT00042614|"~     This study will investigate the causes of acute and chronic rejection of transplanted hearts.~     To find better ways to detect, treat and possibly prevent heart transplant rejection, more~     information about the cause is needed. Acute and chronic heart transplant rejection may be~     caused by certain substances the body produces in response to the new heart. This study will~     try to find a blood or urine test that detects genes and proteins that can serve as markers~     of rejection. Such a test may lead to earlier detection and improved treatment.~      Patients 18 years and above who are on a wait list for heart transplant at a UNOS-approved~     heart transplant center, whose institutional review board has approved this protocol, may be~     eligible for this study. Healthy volunteers will also be included in the study to establish a~     database of normal values for comparison with patients undergoing heart transplant. In~     addition, patients who have had a heart transplant within the past 1 to 5 years will be~     enrolled in a pilot study. Normal volunteers will be screened for participation with an~     electrocardiogram (EKG) and echocardiogram, non-invasive tests to evaluate heart function.~      Participants will undergo the following procedures:~        -  Review of medical records Patients who have had a heart transplant and those on a wait~          list to receive a heart will have their medical records reviewed to collect information~          on their condition.~        -  Blood samples 60 cc (about 3 tablespoons) of blood will be collected from all~          participants by needle stick in a vein. The sample will be analyzed for genes and~          proteins that might predict heart rejection. In addition, many genes in blood cells and~          cells lining blood vessels that are unrelated to heart transplant rejection and whose~          functions or significance are unknown will also be examined for ideas for future~          research. Patients enrolled while on a wait list will, after transplantation, have an~          additional 44 cc (about 2 tablespoons) of blood collected at each heart biopsy and~          rejection episode during the first year of transplant, and 60 cc collected with each~          yearly biopsy for the next 9 years.~        -  Urine samples Between 100 and 300 cc (3 to 10 ounces) of urine may be collected from all~          participants to confirm blood test results~   "
270848|NCT00042536|"~     The purpose of this study is to evaluate the safety and effectiveness of the drugs yohimbine~     and naltrexone in treating men with erectile dysfunction (ED) (the inability to achieve or~     maintain penile erection for satisfactory sexual performance).~      ED is a medical and psychological problem that is usually associated with increased age.~     Evidence suggests that specific neurotransmitter systems are involved in the regulation of~     sexual function. Yohimbine and naltrexone are drugs that may influence these neurotransmitter~     systems. This study will use different doses of yohimbine and fixed doses of naltrexone to~     determine their effectiveness in treating ED.~      Participants in this study will be screened with a medical history, physical examination,~     blood and urine tests, and an electrocardiogram (ECG). The study will consist of three~     outpatient visists.~   "
270849|NCT00042523|"~     This study will examine the possible relationship between certain antibodies found in~     patients with systemic lupus erythematosus (SLE) and cognitive (thought processing)~     impairment in these patients. Antibodies are proteins produced by cells of the immune system~     to fight foreign invaders such as bacteria and viruses. In autoimmune diseases like SLE,~     however, the immune system produces antibodies against the body's own healthy tissues.~     Antibodies targeting the brain may cause cognitive dysfunction. Many patients with SLE have~     mild to severe cognitive impairment involving, for example, short- or long-term memory,~     thought processing and relating objects in time and space.~      Patients 18 years of age and older with SLE may be eligible for this study. Participants will~     undergo the following tests and procedures:~        -  Medical history and physical examination, including blood and urine tests~        -  Psychiatric interview and questionnaire to assess depression~        -  Neuropsychological tests - answering questions given by an examiner or filling out a~          test form or questionnaire~        -  Tests of cognitive function - answering questions given by an automated computer program~          or performing tasks using a computer mouse~        -  Magnetic resonance imaging (MRI) of the brain - a test that uses strong magnetic fields~          and radio waves to generate images of the brain. The patient lies still on a stretcher~          inside a cylinder containing a magnetic field. The patient's head is stabilized with a~          plastic strap and foam pads. During the imaging, a substance called gadolinium-DTPA is~          injected into an arm vein through a catheter (thin plastic tube). This substance is used~          to enhance the images.~      Patients may also be asked to undergo an optional procedure called a lumbar puncture (spinal~     tap) to examine the relationship between cognitive impairment and the amount of antibodies in~     the cerebrospinal fluid (CSF)- fluid that circulates around the brain and spinal cord. For~     this procedure a small area of skin on the lower back is numbed with a local anesthetic. A~     needle is then inserted in the space between the bones in the lower back, and about 2~     tablespoons of CSF is withdrawn through the needle.~   "
270850|NCT00042510|"~     This study will test whether the G17DT Immunogen, when administered in combination with~     chemotherapy, is an effective and safe treatment for gastric cancer.~   "
270851|NCT00042497|"~     The objective is to determine the safety and efficacy of dexosome immunotherapy in patients~     with Stage IV malignant melanoma~   "
270852|NCT00042484|"~     The Community Organizing Network for Environmental Health is a part of Community Action~     Against Asthma (CAAA), which, in turn is a part of the Michigan Center for the Environment~     and Children's Health. It is a community-based intervention research partnership between the~     University of Michigan, community-based organizations, and health care institutions in~     Detroit.~   "
270853|NCT00042471|"~     This is a randomized, open-label, crossover study to examine the bioavailability of~     pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus~     using insulin.~   "
270854|NCT00042458|"~     This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the~     safety of pramlintide treatment using pramlintide dose-titration coupled with insulin~     adjustments in subjects with type 1 diabetes who are actively trying to improve their~     glycemic control.~   "
270855|NCT00042445|"~     The aim of this study is to examine the association of exposure to air contaminants (PAH &~     VOC) emitted from the petrochemical industries, specific genetic polymorphisms (P4501A1 (MspI~     & exon 7) and GSTM1 & T1) of study subjects and their parents, and the risks of brain tumors~     and leukemia among children and youths in metropolitan Kaohsiung, southern Taiwan.~   "
270856|NCT00042432|"~     This study will assess an investigational medication for patients with chronic renal~     insufficiency (pre-dialysis) who have secondary hyperparathyroidism.~   "
270857|NCT00042419|"~     This is a study of the effects of fast paced assembly line work on women. We are studying~     problems women in poultry processing have with their muscles, tendons, and nerves as well as~     acute injuries they have in the workplace. We are also studying how their work affects the~     quality of their lives.~   "
270858|NCT00042406|"~     The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of~     active rheumatoid arthritis in patients who have failed treatment with Methotrexate and at~     least one TNF-alpha blocking agent.~   "
270859|NCT00042393|"~     The purpose of this early access protocol is to provide access to adefovir dipivoxil prior to~     its commercial availability to people with lamivudine-resistant chronic hepatitis B who have~     limited treatment options.~   "
270860|NCT00042367|"~     The purposes of this study are to find the highest dose of mafosfamide that can be given~     without causing severe side effects, to see how well the combination of these chemotherapy~     drugs and lower doses of radiation work to delay or stop the growth of the tumor, and to~     evaluate the pharmacokinetics (how the body handles) of Mafosfamide.~   "
270861|NCT00042354|"~     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the~     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia~     (ALL) who have had at least 2 prior treatment regimens.~      The purpose of this study is to determine whether Clofarabine is safe and effective in the~     treatment of Acute Myelogenous Leukemia (AML.)~   "
270864|NCT00042315|"~     To determine whether tariquidar + first-line single agent vinorelbine chemotherapy in~     patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly~     improve overall survival compared with placebo + vinorelbine. To compare the effects of~     tariquidar/vinorelbine with placebo/vinorelbine on tumor response, time to disease~     progression, performance status, symptom progression, and quality of life in patients with~     Stage IIIb/IV NSCLC.~   "
270865|NCT00042302|"~     To determine whether tariquidar + combined first-line chemotherapy of paclitaxel/carboplatin~     in patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly~     improve overall survival compared with placebo + paclitaxel/carboplatin. To compare the~     effects of tariquidar/paclitaxel/carboplatin with placebo/paclitaxel/carboplatin on tumor~     response, time to disease progression, performance status, symptom progression, and quality~     of life in patients with Stage IIIb/IV NSCLC.~   "
270866|NCT00042289|"~     The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV)~     and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are~     the various interactions between a drug and the body.) This study will also evaluate the PKs~     of certain ARVs in postpartum women before and after starting hormonal contraceptives. The~     PKs of these drugs will be evaluated by measuring the amount of medicine present in blood~     and/or vaginal secretions.~   "
270867|NCT00041483|"~     The purpose of this study is to demonstrate that Anecortave Acetate is as effective after~     twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible~     for initial PDT treatment for wet age-related macular degeneration.~   "
270868|NCT00042380|"~     The purpose of this study is to find out if the soy-based dietary supplement Novasoy~     (Registered Trademark) is effective for the short-term treatment of clinical depression. This~     study will also evaluate whether Novasoy (Registered Trademark) is effective in treating the~     anxiety that often accompanies depression and will assess the best dose level.~      Novasoy (Registered Trademark) is a marketed botanical dietary supplement containing soy~     isoflavones. The active form of the soy isoflavone genistin may be a novel treatment for~     neuropsychiatric illnesses. The soy isoflavone's specific hormonal properties may also have~     beneficial effects on brain function in depressed patients.~      This study will be conducted in two phases. During Phase I, participants will stop all~     medications for at least 1 week. A psychiatric and medical examination will be conducted.~     During Phase II, participants will be randomly assigned to receive either Novasoy (Registered~     Trademark) or a placebo (an inactive pill) for 8 weeks. Participants who do not respond to~     treatment after 5 weeks will be given a higher dose of their assigned medication. After the~     8-week period, participants will be monitored for up to 3 months before being referred back~     to their clinician for further treatment.~   "
270869|NCT00042276|"~     This study will use microdialysis to investigate myofascial pain. This pain is characterized~     by trigger points (exquisitely tender spots) in a group of tense muscle fibers that extend~     from the trigger point to the muscle attachments. Trigger points in the trapezius, a large~     muscle lying between the neck and shoulder, are typically caused by emotional stress,~     postures such as hunching shoulders, certain activities like using a telephone receiver~     without elbow support, or by wearing certain articles such as a heavy coat or heavy purse.~     Microdialysis uses a very thin needle probe (about the size and shape of an acupuncture~     needle) to collect and measure chemicals directly from soft tissue. Analysis of these~     chemicals will show whether changes in the tissue around a muscle with trigger points are~     confined to that muscle, or if these changes also occur in more distant muscles.~      The study will examine two types of trigger points. An active trigger point causes pain or~     other abnormal symptoms and often causes problems with movement. A latent trigger point~     often causes movement problems without causing pain. Many healthy adults have latent trigger~     points.~      People between 21 and 65 years of age with the following characteristics may be eligible for~     this study: 1) no neck pain or trigger points in either upper trapezius muscle; 2) no neck~     pain but a latent trigger point in at least one upper trapezius muscle; or 3) neck pain of~     less than 3 months' duration and an active trigger point in at least one upper trapezius~     muscle. Participants undergo the following procedures:~        -  Physical examination of the muscles of the neck and shoulder area, testing strength and~          range of motion, and response to palpation to find trigger points.~        -  Pain inventory. Subjects complete a questionnaire for measuring pain and its intensity,~          location, quality, causes, relievers, and associated symptoms. The questionnaire is~          filled in before and after each microdialysis procedure.~        -  Microdialysis in upper trapezius muscle. An electrode patch is placed on either side of~          the site for insertion of the microdialysis probe and another electrode is placed on the~          outer edge of the shoulder. The electrodes are used to measure any electrical activity~          that occurs with insertion or movement of the probe. The subject lies face down and the~          probe is inserted in the upper trapezius muscle. It remains in place for 5 minutes while~          chemical substances are collected from the muscle. It is then advanced about 1.5 cm~          deeper into the muscle until a twitch response is obtained and remains in place for 10~          more minutes while substances are collected.~        -  Microdialysis in the gastrocnemius muscle (large muscle of the calf). The same procedure~          for the upper trapezius muscle is done in the calf muscle.~   "
270870|NCT00042263|"~     The Healthy Environments Partnership was established in October 2000, as a part of the~     National Institute of Environmental Health Sciences “Health Disparities Initiative.” The~     Healthy Environments Partnership seeks to expand the knowledge base of how social and~     economic inequalities are linked to disparities in cardiovascular health among residents of~     Detroit. The Healthy Environments Partnership is a project of the Detroit Community-Academic~     Urban Research Center. The partners are: Brightmoor Community Center, Butzel Family Center,~     the Detroit Health Department, Friends of Parkside, Henry Ford Health System, Southwest~     Counseling and Development Services, Southwest Detroit Environmental Vision and University of~     Detroit Mercy and the University of Michigan School of Public Health, School of Nursing, and~     the Institute for Social Research.~   "
270871|NCT00042250|"~     To determine cell cycle parameters and changes after treatment, the labelling agent is given~     and a bone marrow aspiration is accomplished before treatment and after treatment for~     comparison. Participants must be undergoing concurrent therapy for hematologic malignancy.~   "
270872|NCT00042237|"~     The purpose of this study is to compare Schema-Focused Therapy plus antidepressant medication~     and antidepressant medication alone for the treatment of major depression in women with a~     history of childhood sexual abuse.~   "
270873|NCT00042224|"~     This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded~     adequately to clozapine.~   "
270874|NCT00042211|"~     This study will evaluate the effectiveness of a Problem Solving Treatment in preventing~     depression in elderly patients with age-related macular degeneration (AMD).~   "
270875|NCT00042198|"~     This randomized controlled trial will test the efficacy of (1) cognitive behavior therapy and~     (2) supportive stress management as treatments for depression in people who have recently~     undergone coronary artery bypass graft surgery.~   "
270876|NCT00042185|"~     This study evaluated 2 eating disorder prevention programs designed to increase body~     satisfaction among adolescent females with body image concerns.~   "
270877|NCT00042172|"~     The purpose of this study is to evaluate the effectiveness of donepezil (Aricept) for the~     treatment of mild cognitive impairment (MCI) in elderly adults. This study will also~     determine whether adding ginkgo biloba extract (GBE) enhances the effects of donepezil.~   "
270881|NCT00042120|"~     The long term goal of this research is to elucidate the cause(s) of Parkinson's disease, with~     a focus on environmental determinants. We propose to investigate the relationship between~     Parkinson's disease and exposure to pesticides and other factors by conducting a nested~     case-control study in the Agricultural Health Study.~   "
270882|NCT00042107|"~     The aim of this research is to discover genes which modify risk for Parkinson's disease. The~     study includes 800 patients with Parkinson's disease, and their estimated 1,222 available~     siblings. Common variations of at least 9 genes will be studied, including genes associated~     with personality, substance use, and anxiety and depression.~   "
270883|NCT00042094|"~     This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured~     vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will~     be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a~     blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of~     volunteers will be followed up to 3 years in order to evaluate the duration of immunity~     following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and~     randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a~     sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive~     volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25,~     and 1:50).~   "
270884|NCT00042081|"~     The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F~     Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft~     failure after coronary artery bypass surgery.~   "
270885|NCT00042068|"~     A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective~     and safe three different doses of meloxicam are compared with placebo in Rheumatoid~     Arthritis. Patient will take one dose of study medication daily.~   "
270886|NCT00042055|"~     Patients with moderately to severely active Crohn's disease will be treated with oral CP-461~     200 mg (2 x 100 mg capsules) twice-daily for 8 weeks.~      The purpose of this study is to see if CP-461 improves the symptoms of Crohn's disease and/or~     the patient's quality of life. Patient's safety will be monitored throughout the study.~   "
270887|NCT00042042|"~     The purpose of this study is to evaluate the prevalence of Type 2 diabetes or impaired~     glucose tolerance in a subset of children 10-19 years of age in an inner city community~     clinic. The demographics of the clinic are 75% African American, 20% Hispanic, 5% other.~     African American and Hispanic patients have a higher prevalence of diabetes with significant~     morbidity, predominantly from microvascular and macrovascular disease. Obesity is commonly~     seen in patients with Type 2 diabetes and contributes to the underlying insulin resistance~     seen in the disease. Obesity is an increasing health problem among adolescents. Since Type 2~     diabetes can be present for several years before diagnosis, it is worrisome that younger~     children will have undiagnosed Type 2 diabetes for years. This will increase the risk of~     earlier complications in these patients as young adults.~      We hypothesize that the occurrence of abnormal glucose metabolism in 400 children with either~     a history of obesity, family history of diabetes mellitus, or symptoms suggestive of diabetes~     mellitus will be higher than the general pediatric population. We believe that a family based~     educational program can reduce fasting plasma glucose.~   "
270888|NCT00042029|"~     A clinical study to determine the efficacy and safety of MK0869 in the treatment of~     depression.~   "
270889|NCT00042016|"~     To determine the safety and efficacy of decitabine in patients with Philadelphia~     chromosome-positive chronic myelogenous leukemia chronic phase that were previously treated~     with imatinib mesylate (STI 571) and became resistant/refractory or were found to be~     intolerant to the drug.~   "
270890|NCT00042003|"~     To determine the safety and efficacy of decitabine in patients with Philadelphia~     chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated~     with imatinib mesylate (STI 571) and became resistant/refractory or were found to be~     intolerant to the drug.~   "
270891|NCT00041990|"~     To determine the safety and efficacy of decitabine in patients with Philadelphia~     chromosome-positive chronic myelogenous leukemia accelerated phase that were previously~     treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be~     intolerant to the drug.~   "
270892|NCT00041977|"~     The purpose of this study is to determine whether Periostat(R), Doxycycline Hyclate 20 mg~     Tablets, taken twice daily is effective in reducing the red and white heads and overall~     redness associated with rosacea.~   "
270893|NCT00041964|"~     The purpose of this study is to find out if HIV-infected pregnant women taking anti-HIV drugs~     have an increased amount of HIV in their blood (viral load) after having the baby.~      The purpose of A5153s, a substudy of A5150, is to characterize two anti-HIV drugs (nelfinavir~     [NFV] and lopinavir/ritonavir [LPV/r]) in HIV-infected women during pregnancy and after~     childbirth.~      Sometimes pregnant women have an increase in their HIV viral load after their baby is born.~     This study will try to find out how often this happens. It will also examine possible reasons~     why the increase in viral load occurs.~   "
270894|NCT00041951|"~     The purpose of our study is to identify gene(s) involved in the cause of childhood absence~     epilepsy (CAE).~   "
270895|NCT00041938|"~     The purpose of this study is to determine which of two treatments, Warfarin or aspirin, is~     better for preventing death and stroke in patients with poor heart function.~      We are now transitioning into the sub-analysis part of the WARCEF patient data.~      The study has recently completed data analysis for its Primary Aim. All randomized patients~     have completed their follow up. All study related procedure as per the protocol has been~     completed. We are now in the extension phase of the study to obtain more patient data to~     address further aims of the study. No new procedures are performed and data already in place~     at the sites will be collected (EKG and echocardiograms).~      The aims for this study extension are:~        -  To assess progression of cardiac dysfunction over time among heart failure patients~        -  To correlate prognosis with cardiac dysfunction~   "
270896|NCT00041925|"~     The purpose of this study is to determine the efficacy of graft pretreatment with the E2F~     decoy, CGT003, as compared to placebo, on the occurrence of graft failure among patients who~     receive autogenous vein grafts to treat chronic critical limb ischemia; on the occurrence of~     clinically significant graft stenosis (more than or equal to 70%); and on the incidence of~     critical limb ischemia (e.g., gangrene, non-healing ischemic ulcers or ischemic rest pain).~   "
270897|NCT00041860|"~     The research is to evaluate benzene metabolism after exposure at levels that can be found in~     the environment, such as the higher end concentrations in the air inside cars and buses while~     being driven in heavy traffic and inside private and public parking garages. To do so breath,~     urine, and blood samples prior to, during and after being exposed to benzene as well as~     benzene levels and benzene metabolites present are measured.~   "
270898|NCT00041847|"~     The purpose of this study is to determine whether certain environmental factors, namely~     occupational exposures and diet, have a greater effect on prostate cancer risk in the~     presence of selected inherited genetic factors.~   "
270899|NCT00041834|"~     This study surveys the parents/guardians about symptoms and diagnosis of asthma in~     kindergarten and first-grade students in 13 schools around the city of Anchorage, Alaska.~     Traffic information is also measured and entered in geographical information mapping system~     with student's home and school locations. The study will assess whether students living in~     high traffic areas have greater risk of diagnosis of asthma.~   "
270900|NCT00041821|"~     This study seeks to document differences in nasal irritant sensitivity within the population.~     The investigators are interested in knowing whether age, gender, and allergy status (nasal~     allergies) predict nasal irritant sensitivity. This is important in understanding symptom~     reporting patterns in air pollution situations (particularly in so-called problem~     buildings), as well as in understanding the reflex mechanism of a response of the nose to~     irritants (e.g., nasal congestion).~   "
270901|NCT00041899|"~     This study will compare blood levels of the drug CDB-2914 in healthy women receiving the~     compound in crystalline powder form with the blood levels of women receiving an identical~     dose of the drug in micronized form. Generally, absorption of compounds made into a~     crystalline powder is less than that of micronized compounds, in which the substance is~     processed into many similar-sized particles.~      CDB-2914 is a manmade hormone similar to the hormones cortisol and progesterone. The National~     Institute of Child Health and Human Development is evaluating the ability of this drug to~     treat reproductive conditions. Institute studies have shown that CDB-2914 can increase the~     time to produce a mature egg in the ovary, and cause an early menstrual period, CDB-2914~     might be used to treat fibroids and endometriosis pain. As part of its evaluation for these~     purposes, this study will determine if absorption of crystalline and micronized powder forms~     of CDB-2914 result in the same blood levels of the drug.~      Women between 18 and 50 years of age who are in good health may be eligible for this study.~     Premenopausal women must not be pregnant (as determined by a urine pregnancy test) or~     breastfeeding and must practice birth control during the study. Candidates will be screened~     with a medical history, physical examination, and blood and urine tests. Women who use an IUD~     for contraception are advised to also use a barrier contraceptive (diaphragm or condom) the~     week after taking CDB-2914.~      Participants will be admitted to the NIH Clinical Center inpatient service or the outpatient~     day hospital twice for pharmacokinetic studies (blood drawing to measure blood levels of~     CDB-2914 after a single dose of the drug). They will come to the Clinical Center at 7:00 a.m.~     and have a catheter (thin plastic tube) inserted into an arm vein for drawing blood for the~     first 24 hours of the study. Eight milliliters (about 2 teaspoons) of blood will be drawn 5~     minutes and 1 minute before taking CDB-2914 (in either crystalline or micronized powder form)~     and then at the following times after taking the drug: 15, 30, 45, 60, 75, 90, 105, 120, 150~     and 180 minutes (3 hours), and 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hours (5 days).~      Participants will take all their meals in the day hospital or ward during the first 26 hours~     of sampling. Inpatients will leave the hospital after the 24-hour blood draw and return as an~     outpatient on days 2 through 5. At the 48-hour time point, additional blood will be drawn to~     check blood counts and chemistries, and for liver and kidney function tests.~   "
270902|NCT00041886|"~     Radiofrequency ablation is used to treat patients with many different conditions. It is used~     to treat heart arrhythmia and benign bone tumors, and to control bleeding during surgery. It~     has been approved by the Food and Drug Administration for soft tissue ablation (removal). The~     technique involves inserting a probe, guided by computed tomography or ultrasound, and~     sending radio waves through the probe. The radio waves generate heat, which both destroys~     adjacent tissue and cauterizes blood vessels.~      This study will enroll 15 adults (age 18 or older) with soft tissue metastases who suffer~     pain that is not well controlled by other means, such as drugs. The goal is to reduce their~     pain or their use of analgesics by partially destroying some of their tumors.~      Patients will be ineligible for the study if they change the class of pain medication they~     use within 2 weeks before or 2 weeks after the study treatment. Patients will fill out short~     questionnaires about pain and daily activities (Brief Pain Inventory) before treatment and 1~     day, 1 week, 1 month, 3 months, and 12 months after treatment to ascertain whether their pain~     is better controlled with less pain medication.~      For the treatment, most patients will receive local anesthetic in the area where the probe is~     inserted. Some patients may require general anesthesia. The probe will remain in place~     typically for 10 to 30 minutes. For larger tumors, it may be inserted at different positions.~   "
270903|NCT00041808|"~     MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to “stick”, to~     magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is~     added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and~     deposited in the area of a tumor, where it is thought that it then leaks through the blood~     vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes free~     from the magnetic beads and will then be able to act against the tumor cells. The iron~     component of the particle has magnetic properties, making it possible to direct MTC-DOX to~     specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that~     MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and~     provide a treatment to patients with cancers that have spread to the liver.~   "
270904|NCT00041795|"~     This study will assess the safety and efficacy of Neotrofin in treating the peripheral~     neuropathy that results from chemotherapy for cancer.~   "
270905|NCT00041782|"~     Study Plan: Adult cancer patients who have a low risk profile and present with DVT will~     receive dalteparin 200 IU/kg subcutaneously daily (based on actual body weight with a maximum~     dose of 18,000 IU). Eligible patients who have signed the informed consent will be instructed~     on injection technique, will give themselves their first subcutaneous injection under~     supervision of the physician or the nurse and will be observed for a minimum of 1-2 hours~     prior to discharge. Patients may be admitted to an observation unit for up to 24 hours prior~     to discharge if medically necessary. Those patients without complications during the~     observation period will be given discharge instructions and an outpatient schedule to see one~     of the physician investigators daily for their subcutaneous injection of dalteparin, routine~     lab work and initiation of oral anticoagulation therapy.~      Patients that are proficient in administering their own injection with dalteparin will be~     evaluated every other day by the physician investigator. On days of home injection, the study~     nurse will call the patient to check on the patient's status and to remind the patient of~     his/her daily injection. Patients will undergo a physical examination every other day by the~     physician investigator directed towards the clinically affected areas until a therapeutic~     response (INR 2-3) on oral warfarin has been achieved or the patient's clinical condition~     warrants modification of therapy with or without hospitalization. Patients will remain on~     study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation.~      The quality of life of the patients enrolled will be assessed by using the Modified Medical~     Outcome Study Short Form-20. An adapted version of the Rotterdam Symptom Checklist will be~     used to specifically assess patients with thrombosis. Patients will complete these two~     instruments at study entry, day 3, day 5 and at the end of study if different from day 5.~   "
271044|NCT00038545|"~     For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma~   "
270906|NCT00041769|"~     Drug resistance testing can be used to see which anti-HIV drugs are likely to suppress the~     growth of HIV and to select an anti-HIV regimen for HIV infected patients who have failed~     previous drug regimens. Therapeutic drug monitoring (TDM) is a process that involves~     measuring blood levels of a drug and may further increase the benefits that resistance~     testing offers by optimizing protease inhibitor (PI) drug concentrations. The purpose of this~     study is to determine whether changing the dose of PIs, as indicated by TDM, reduces the~     viral load in PI-experienced patients.~      Hypothesis: Treatment-naive study participants who undergo TDM and whose clinicians'~     interpret their TDM results and adjust their PI doses will have better virologic response~     rates and decreased toxicities (and thus better treatment outcomes) than participants who do~     not undergo TDM.~   "
270907|NCT00041756|"~     Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742~     inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This~     study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate~     knee osteoarthritis.~   "
270908|NCT00041743|"~     This is a study examining the use of different degrees of therapist involvement in the~     treatment of Binge Eating Disorder. The study will examine both which approaches work best~     for decreasing symptoms and which are most cost-effective.~   "
270909|NCT00041730|"~     The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus~     FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their~     idiotype.~   "
270910|NCT00041717|"~     Normally, nerve fibers carry electrical impulses through the spinal cord, providing~     communication between the brain and the arms and legs. In people with spinal cord injury,~     some fibers may be destroyed at the site of injury, while others remain connected but do not~     work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal~     cord injury may have spasticity which is muscle spasms or muscle stiffness that makes~     movement difficult. Fampridine-SR is an experimental drug that increases the ability of the~     nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on~     moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as~     bladder control, bowel function and sexual function. The study will also examine the possible~     risks of taking Fampridine-SR.~   "
270911|NCT00041704|"~     Anidulafungin is an antifungal agent of the echinocandin class which is highly active in~     vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has~     demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as,~     in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC~     an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety~     are inadequate in the treatment of this disease.~   "
270912|NCT00041691|"~     The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in~     the treatment of residual colorectal cancer following recent surgery.~   "
270913|NCT00041678|"~     The purpose of this study is to learn if aripiprazole is safe and effective in the treatment~     of psychosis associated with dementia of the Alzheimer's type.~   "
270914|NCT00041665|"~     Radiotherapy and high dose chemotherapy with bone marrow transplantation or peripheral blood~     stem cell transplantation is frequently used as treatment for patients with cancers of the~     bone marrow or lymph nodes such as Hodgkin's disease, non-Hodgkin's lymphoma, leukemia or~     multiple myeloma. A common side effect of the radiotherapy and high dose chemotherapy is~     mucositis (inflammation of the inside of the mouth and throat resulting in pain and~     difficulty swallowing). Mucositis is often very severe such that patients receive intravenous~     nutrition and pain medication in the hospital.~      In this study, an investigational recombinant human growth factor called Keratinocyte Growth~     Factor (rHuKGF) is being evaluated to determine its protective effect on the mucosal tissue~     and its ability to reduce the mouth and throat soreness.~   "
270915|NCT00041652|"~     The purpose of this trial is to determine the safety of hMN14 at different dose levels in the~     treatment of either colorectal or breast cancer.~   "
270916|NCT00041639|"~     The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in~     the treatment of pancreatic cancer.~   "
270917|NCT00041626|"~     There is a need for more treatment options for patients with recurrent squamous cell cancer~     of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that~     include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the~     development of tumors. In this study the transfer of the p53 gene to tumor cells using a~     modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil)~     will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed~     surgery and radiotherapy.~   "
270918|NCT00041613|"~     There is a need for more treatment options for patients with recurrent squamous cell cancer~     of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that~     include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the~     development of tumors. In this study the transfer of the p53 gene to tumor cells using a~     modified adenovirus (INGN 201) will be compared to methotrexate in patients who have failed~     surgery, radiotherapy and chemotherapy with platinum or taxanes.~   "
270919|NCT00041600|"~     The purpose of this study is to identify genes responsible for epilepsy and disorders of~     human cognition.~   "
270939|NCT00040027|"~     Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the~     United States. Approximately one-third of patients with hepatitis C infection develop~     cirrhosis of the liver, which can lead to liver failure or liver cancer. The current~     treatment for hepatitis C infection in previously untreated patients is successful in only~     about half of patients. There is no established therapy for non-responders.~      This is a randomized, double-blinded, multicenter trial to determine the effectiveness of~     thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk~     compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C without~     cirrhosis who are non-responders to previous treatment with interferon or interferon plus~     ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a~     course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and~     will be followed-up for a further 6 months after the end of therapy.~   "
270940|NCT00040599|"~     The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in~     the treatment of colorectal cancer.~   "
270920|NCT00041587|"~     IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a~     bacteria toxin). IL13-PE38QQR is a protein that exhibits cell killing activity against a~     variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic~     benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the~     IL13 receptors was shown to be highly specific for human glioma cells.~      Prior to treatment, patients will have physical and neurologic exams, MRI to measure the~     extent of tumor, tumor biopsy, and screening laboratory tests. On Day 1, one or two catheters~     will be inserted directly into the tumor, after which a CT scan will be used to confirm~     placement. Each patient will receive one IL13-PE38QQR infusion, and the tumor will be~     surgically removed on approximately Day 15. In the first group of patients, IL13-PE38QQR will~     be infused directly into the tumor for 4 days. Depending on effectiveness or side effects of~     the study drug, the duration will be increased stepwise to a maximum of 7 days in subsequent~     groups of patients. Once duration of infusion has been determined, the dose of IL13-PE38QQR~     will be increased stepwise (in separate groups of patients), depending on effectiveness or~     side effects of the study drug. The activity of the drug against the tumor cells will be~     judged by examining the removed tumor tissue. Patients will have neurologic exams and MRI~     scans immediately after the resection and every eight weeks until disease progression is~     observed.~   "
270921|NCT00041509|"~     The purpose of this study is to gain additional safety information as well as to determine~     after the study drug has been given to patients who have undergone total hip replacement~     surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood~     clots in legs) or pulmonary embolism (blood clots in lungs).~   "
270922|NCT00041496|"~     The purpose of this study is to determine whether the study drug is effective in preventing~     the recurrence of atrial fibrillation (an abnormal heart rhythm).~   "
270923|NCT00041574|"~     The purpose of this program is to evaluate the logistic issues and patient requirements for~     chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient~     needs, patients with a variety of underlying diseases will be included. Safety of chronic~     therapy will be monitored by serial measurements of methemoglobin, platelet function assay~     and reported adverse events.~   "
270924|NCT00041561|"~     The purpose of this study is to determine the effect of nitric oxide for inhalation on the~     duration of mechanical ventilation in pediatric patients with AHRF.~   "
270925|NCT00041548|"~     The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas~     by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen),~     within one hour of initiation and with no significant adverse effects.~   "
270926|NCT00041535|"~     Gaucher disease is an inherited functional deficiency of glucocerebrosidase. This enzyme~     breaks down a fatty substance (lipid) called glucocerebroside, which is present in all cells~     of the body. When cells renew themselves, the lipids must be broken down and discarded.~     Because the enzyme does not function well, the lipid builds up in certain tissues, such as~     the liver and spleen. The nervous system is involved as well; memory is impaired and it is~     difficult to move the eyes from side to side. It has been shown that repeated infusions of~     glucocerebrosidase help break down the stored lipid. However, this treatment does not improve~     any neurological symptoms.~      A medicine called OGT 918 has been shown to slow the production of the lipid that builds up~     in Gaucher disease. It also has been shown to enter the brain. It is hoped that taking OGT~     918 will reduce the storage of glycolipids in cells and improve the neurological symptoms of~     the disease. This clinical trial seeks to evaluate OGT 918 as a treatment for neuronopathic~     Gaucher disease by assessing changes in eye movement velocity. A secondary goal is to assess~     the clinical safety and tolerability of OGT 918 therapy.~      Up to 30 patients from the National Institutes of Health and the Institute of Child Health~     (London) will be randomly assigned to OGT 918 or no treatment for 12 months. Study~     participants must be clinically diagnosed with neuronopathic Gaucher disease, 12 years of age~     or older, and able to swallow capsules. They must have been stable on ERT for at least 6~     months before the study.~      Patients receiving OGT 918 will receive a dose of 200 mg OGT 918 three times daily. Data~     analysis will be done after 12 months. The study will be extended up to 12 months to collect~     safety and efficacy data. All patients who complete the main study and enter the extension~     study will receive OGT 918.~      During a 4-week screening period, eye movement velocity will be measured. These assessments~     will be repeated at months 12 and 24. Also at screening and months 12 and 24, the following~     tests will be done: MRI/CT, to measure spleen and liver volume; pulmonary imaging (by X-ray)~     and function tests; nerve conduction velocity studies and neuropsychological assessments;~     evoked response studies (to measure how the brain conducts electrical messages); and tremor~     measurements. Additional assessments for tremor will be conducted at months 6 and 18.~      Plasma samples will be obtained every 3 months to measure disease markers and safety~     profiles. Proteasome samples will be taken at screening and month 6 to identify proteins that~     may be associated with Gaucher disease. Blood will be obtained at month 1 from the first 6~     consenting patients who have been randomly assigned to take OGT 918. These patients will also~     have a cerebrospinal fluid sample taken by lumbar puncture at month 1. These samples will be~     measured for how much OGT 918 is present.~      All patients receiving OGT 918 will have an initial assessment 1 week after beginning~     treatment to evaluate tolerance of the therapy. Clinic visits will be every 3 months. All~     patients will be asked to keep a simple diary of adverse events and dietary information. Dose~     levels may be reduced if a patient experiences severe gastrointestinal problems.~   "
270927|NCT00041470|"~     The purposes of this are:~        -  To determine the highest doses of Taxol and Navelbine that we can safely give to~          patients;~        -  To determine what kind of side effects are caused by the combination of Taxol, Navelbine~          and G-CSF;~        -  To determine whether the combination of Taxol, Navelbine and G-CSF is more effective~          than standard therapy in treating metastatic breast cancer and prolonging life;~   "
270928|NCT00040677|"~     ICA-17043 is being developed for the chronic treatment of patients with sickle cell disease~     (SCD) in both adults and children. ICA-17043 is a potent and specific inhibitor of a channel~     in human red blood cells (RBCs) that blocks RBC dehydration. ICA-17043 is expected to inhibit~     RBC dehydration and thus should prevent or delay the sickling process. By reducing sickled~     cells, an improvement in anemia, a reduction in painful crises, and ultimately, less~     end-organ disease is anticipated.~   "
270929|NCT00040664|"~     This is a 48-week study to collect additional information on the safety, tolerability,~     pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy)~     including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.~   "
270930|NCT00040651|"~     Scleroderma, or systemic sclerosis (SSc), is a diffuse connective tissue disease~     characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs.~     The purpose of this study is to determine the safety and value of self bone marrow~     transplants after chemotherapy in patients with severe SSc.~   "
270931|NCT00041457|"~     To evaluate potentially modifiable lifestyle predictors of venous thromboembolism and their~     joint associations with biochemical and genetic determinants.~   "
270932|NCT00041444|"~     To evaluate the relation of retinal microvascular characteristics to subclinical~     cardiovascular disease, clinical disease, and their risk factors in the Multi-Ethnic Study of~     Atherosclerosis (MESA) cohort.~   "
270933|NCT00041431|"~     To determine the effects of estrogen therapy on postmenopausal women with congestive heart~     failure.~   "
270934|NCT00041418|"~     To use magnetic resonance imaging to identify subclinical atherosclerosis and left~     ventricular hypertrophy in the Framingham Heart Study cohort.~   "
270935|NCT00041405|"~     To determine the effect of the method of hyperglycemic management on pro- thrombotic~     potential in diabetic subjects.~   "
270936|NCT00041392|"~     The purpose of this study is to examine the effects of supplemental magnesium on the~     neurocognitive function of individuals undergoing coronary artery bypass graft (CABG)~     surgery.~   "
270937|NCT00040638|"~     The purpose of this study is to determine the effectiveness of TLK286 in the treatment of~     advanced non-small cell lung cancer.~   "
270938|NCT00040625|"~     This study is to evaluate the effects (good and bad) of ALIMTA and Cisplatin or ALIMTA alone~     on you and your malignant pleural mesothelioma as well as make ALIMTA available to patients~     who qualify for treatment.~   "
270941|NCT00040586|"~     The monoclonal antibody J591 is being investigated as therapy for patients with prostate~     cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is~     an open-label, non-randomized phase II study for patients with documented hormone refractory~     prostate cancer.~   "
270942|NCT00040573|"~     This drug is being developed to treat a type of brain cancer, glioma. This study was designed~     to determine a safe and well tolerated dose. Patients must have had prior treatment for their~     glioma and be eligible for removal of their recurring tumor.~   "
270943|NCT00040560|"~     The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when~     used with planar and SPECT imaging for the detection of lung cancer and brain cancer~     consistent with metastatic lung cancer.~   "
270948|NCT00040482|"~     Multiple Sclerosis is a disease that may be caused by the immune system reacting against the~     nervous system. It is possible, that by changing the immune system we can modify the~     progression of this disease. In this study, we will try to learn whether treatment with a~     bone marrow transplant (BMT) can help patients with multiple sclerosis. We will also try to~     learn what the side effects are of this treatment in patients with multiple sclerosis.~   "
270949|NCT00040469|"~     The major goal of this study is to determine the risks and benefits of bone marrow~     transplants in patients with severe thalassemia or sickle cell disease. Participation in this~     project will be for two years.~   "
270950|NCT00040456|"~     Subjects have a form of sickle cell disease, called hemoglobin SC disease. This results in~     abnormally shaped red blood cells that get 'stuck' in blood vessels and then results in~     episodes of severe pain (pain crises). Patients with the more common form of sickle cell~     disease, called hemoglobin SS disease, also suffer from pain crises. Treatment with the drug~     hydroxyurea is available to help prevent the pain crises in hemoglobin SS disease, but there~     is no good treatment to help prevent the pain crises in hemoglobin SC disease.~      It has been shown that one of the reasons for the formation of the abnormally shaped red~     blood cells in patients with SC disease is the fact that these cells do not contain enough~     water; they are dehydrated. Drinking more water will not increase the amount of water in the~     cells. Certain salts and minerals can however have an effect on the amount of water in the~     red blood cells. One of the most important minerals influencing this is called magnesium.~     Magnesium is present in food and also in certain medications used to treat heartburn.~     Magnesium has been used successfully both in animals and people to increase the amount of~     water in the red blood cells and is very well tolerated by most people.~      Investigators are using a new form of magnesium known as magnesium pidolate because this form~     of magnesium may help with the symptoms of disease without causing diarrhea (a common side~     effect of magnesium products).~      Purpose The purpose of this study is to find out whether treatment with magnesium pidolate~     will increase the amount of water in the red blood cell and result in fewer painful crises in~     patients with hemoglobin SC disease while not causing diarrhea.~      The study will last for about 64 weeks (about 16 months).~   "
270951|NCT00040443|"~     Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild~     cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is~     evidence CX516 enhances brain activity by specifically targeting remaining glutamate~     receptors in the affected portions of the brain. This study will test the safety and efficacy~     of CX516 in the symptomatic treatment of participants with mild cognitive impairment.~   "
270952|NCT00040430|"~     The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when~     used with planar and SPECT imaging for the detection of breast cancer.~   "
270953|NCT00040508|"~     This study will determine the safety and effectiveness of sirolimus (Rapamune® (Registered~     Trademark)) in treating focal segmental glomerulosclerosis (FSGS), a disease involving kidney~     scarring and increased protein in the urine. About one-half of patients with FSGS go on to~     develop end-stage kidney disease within 6 years, requiring dialysis or kidney transplant.~     Therapies to reduce urine protein are likely to stop the progression of renal scarring and~     reduce the chance of developing kidney failure. However, current treatments for FSGS, such as~     prednisone, cyclophosphamide, and cyclosporine, are not effective in many patients and can~     cause serious side effects. This study will see if sirolimus, a drug with both anti-scarring~     and immune suppressing properties, can lower the amount of protein in the urine and slow or~     stop the kidney disease.~      Patients 13 years of age and older with FSGS who have had at least one standard treatment for~     FSGS may be eligible for this 24-month study. Pregnant and nursing women may not participate.~     Candidates will be screened with a medical history and physical examination, review of~     medical records and kidney biopsy, 24-hour urine collection, and blood tests.~      Participants will take sirolimus tablets once a day for 1 year. Three 24-hour urine~     collections will be done before starting treatment. Blood will be drawn to measure drug~     levels every week for the first month after starting treatment, then every other week for 1~     month, and then every 2 months until treatment stops. Patients who do not have a complete~     response to the drug at low levels will have their dose increased. Patients will be seen at~     the NIH clinic in Bethesda, Md., for the screening visit and then at 1, 4, 8, 12, and 15~     months for blood and urine tests. Additional urine collections and blood tests will be done~     periodically throughout the 24-month study period by the patient's local physician.~      Patients whose urine protein decreases on therapy will be asked to wait 3 months before~     starting another treatment and will monitored during that time to determine if the response~     is sustained. Patients whose urine protein levels do not decrease with sirolimus will not be~     asked to wait 3 months before starting another therapy. Follow-up with the local physician~     will continue at 18 and 24 months after starting the study.~      Patients whose urine protein levels increase with sirolimus treatment will be taken off the~     study and may seek other treatment at any time.~   "
270954|NCT00040417|"~     The major goal of this study is to determine the risks and benefits of stem cell transplants~     in combination with a newer, less toxic conditioning chemotherapy treatment in patients with~     severe sickle cell disease (SCD) or sickle hemoglobin variants (hemoglobin SC or hemoglobin~     SB0/+), or homozygous b0/+ thalassemia or severe B0/+ thalassemia variants. Participation in~     this project will be for one year, with follow up evaluations done every 6 months thereafter~     for 10 years or until participants are 18 years old.~   "
270955|NCT00040404|"~     The purpose of this study is to establish safety for CEP-1347 and to determine an efficacious~     dose in the treatment of Parkinson's disease.~   "
270956|NCT00040391|"~     The study will combine a new investigational drug with standard anti-cancer drugs for the~     treatment of advanced colorectal cancer. The standard and approved treatment for colorectal~     cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11,~     Camptosar), 5-fluorouracil (also known as 5-FU), and leucovorin (also known as LV). This is~     known as the triple therapy. One of the major side effects of CPT-11/5-FU/LV chemotherapy~     treatment is diarrhea. The purpose of this research study is to see whether adding this~     investigational drug to the standard treatment for advanced colorectal cancer can reduce the~     amount of diarrhea a patient experiences. This study will also determine if adding the~     investigational drug to triple therapy has a positive effect on tumors.~   "
270957|NCT00040378|"~     The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) prevention trial~     is an important addition to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). As a~     prevention trial, PREADVISE is trying to find out if taking selenium and/or Vitamin E~     supplements can help to prevent memory loss and dementia such as Alzheimer's disease.~   "
271021|NCT00038857|"~     Donor:~      This clinical study will evaluate the feasibility of a purified CD34 peripheral blood~     progenitor cell (PBPC) transplants in patients with hematological malignancies.~      The primary objectives of the study are to evaluate the recipient obtaining donor derived~     neutrophil engraftment and the incidence of acute graft versus host disease [GvHD] (grade~     III-IV).~      Secondary objectives include assessments of recipient having donor derived platelet~     engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival,~     clinical safety and device performance of the CliniMACS CD34 selection device.~   "
270958|NCT00040365|"~     This study will evaluate the safety and effectiveness of a drug called amifostine in reducing~     the bowel side effects of radiation treatment for prostate cancer. Amifostine is a~     'radioprotector' medicine that to protects normal tissue from radiation damage. This study~     will determine whether placing amifostine in the rectum during radiation treatment for~     prostate cancer can decrease common side effects of treatment, including diarrhea, painful~     bowel movements, bleeding, and gas.~      Patients 18 years of age or older with prostate cancer may be eligible for this study.~     Candidates will be screened with a medical history and physical examination, blood tests,~     bone scan if a recent one is not available, and possibly computed tomography (CT) and~     magnetic resonance imaging (MRI) scans of the pelvis. They will also have a liquid retention~     test, in which they are given an enema of 4 tablespoons of salt water that they must retain~     for 20 minutes.~      Participants will receive standard radiation therapy for prostate cancer-5 consecutive days~     for 8 weeks-in the National Institutes of Health (NIH) Radiation Oncology Clinic. Amifostine~     will be placed in the rectum by a mini-enema before each radiation treatment so that it~     covers the lining of the rectum. To determine the side effects of the treatment, patients~     will undergo a proctoscopic examination before beginning radiation therapy, two times during~     therapy, and at each follow-up visit for 5 years after treatment ends. This examination~     involves inserting a proctoscope (a thin flexible tube with a light at the end) into the~     rectum and taking pictures.~      Patients will be followed in the clinic at visits scheduled 1, 3, 6, 12, 18, 24, 36, 48, and~     60 months after treatment for a physical examination and routine blood tests, proctoscopic~     examination, and review of bowel symptoms.~   "
270959|NCT00040352|"~     This study will investigate how genetic and environmental factors contribute to the~     development of melanoma, a type of skin cancer, and related conditions.~      Individuals of any age with a personal or family history of melanoma may be eligible for this~     study. Participants will:~        -  Fill out one or two questionnaires about their personal and family medical history.~        -  Provide written consent for researchers to review their medical records and pathology~          materials related to their care and those of deceased relatives with melanomas, tumors,~          cancer, or other related illnesses for whom they are the next-of-kin or legally~          authorized representative.~        -  Donate a blood or cheek cell sample to be used for genetic studies. (The blood sample is~          collected through a needle in an arm vein. The cheek cell sample is obtained either by~          gently brushing the inside of the mouth with a soft brush or by swishing a tablespoon of~          mouthwash and then spitting it into a container.)~        -  Undergo a skin biopsy (removal of a small piece of skin tissue) for genetic study. For~          this procedure, the area of skin to be removed is numbed with a local anesthetic and a~          1/4-inch piece of skin is excised with a cookie cutter-like instrument. The wound is~          then covered with a band-aid.~      Participants may be asked to travel to the NIH Clinical Center for evaluation, including a~     medical history, physical examination, and some of the following procedures:~        -  Full body skin examination to evaluate the type and number of moles and document any~          evidence of sun damage to the skin. The examination involves all the skin from the scalp~          to the bottoms of the feet. After the examination, a medical photographer will~          photograph the skin, with close-ups of skin lesions marked by the examiner. If there are~          parts of the skin the participant does not want examined or photographed, he or she can~          tell the examiner.~        -  Blood draw of about 120 milliliters (4 ounces) or less~        -  Skin biopsy~        -  Cheek cell sample~        -  X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or~          changes in tumors or other types of changes in specific tissues. MRI is a diagnostic~          test that uses strong magnetic fields and radiowaves to examine body tissues. The~          subject lies on a table that is moved into a large tunnel-like machine (the scanner) for~          about 45 minutes to 1 hour.~      When the tests are finished, a doctor will discuss the results with the participant and the~     need, if any, for clinical follow-up.~   "
270960|NCT00040339|"~     The purpose of this trial is to determine if hypothermia (body cooling), administered very~     soon after a severe brain injury improves functional outcome. This pilot trial ended in July~     2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of~     the trial (see link below).~   "
270961|NCT00040326|"~     The purpose of this trial is to compare the effectiveness of early surgical intervention for~     mesial temporal lobe epilepsy to continued treatment with antiepileptic drugs.~   "
270962|NCT00040313|"~     The purpose of the study is to determine whether pegaptanib sodium (Macugen) is safe and~     effective in slowing the leakage of fluid within the retina and thereby stabilizing or~     improving vision when compared to placebo injections. A total of 176 patients will be~     enrolled~   "
270963|NCT00040300|"~     The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how~     the body reacts to Racivir will be studied.~   "
270964|NCT00040287|"~     The purpose of this study is to examine a new theory for understanding the processes that~     govern behavior change by observing how people’s beliefs and feelings about smoking cessation~     or weight loss change as they participate in smoking cessation or weight control programs.~     This study also seeks to improve the ability of treatment programs to help people maintain~     changes in their behavior.~   "
270965|NCT00040274|"~     The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body~     responds to the drug will be studied.~   "
270966|NCT00040183|"~     The purpose of this study is to determine if OSI-774 will improve overall survival when~     combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with~     pancreatic cancer.~   "
270967|NCT00040170|"~     This study involves the use of an experimental product, TG4010. The purpose of the study is~     to determine if TG4010 can stimulate the body's immune system to help it fight the cancer.~   "
270968|NCT00040157|"~     To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection~     who have modestly detectable viral load while on stable triple combination antiretroviral~     therapy including 3TC.~   "
270969|NCT00040144|"~     The purpose of this study is to determine the safety and antiviral HBV activity of ACH126,~     433 (b-L-Fd4C) in the treatment of adults with lamivudine-resistant chronic Hepatitis B.~   "
270983|NCT00039962|"~     Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the~     United States. Approximately one-third of patients with hepatitis C infection develop~     cirrhosis of the liver, which can lead to liver failure or liver cancer. The current~     treatment for hepatitis C infection in previously untreated patients is successful in only~     about half of patients. There is no established therapy for non-responders.~      This is a randomized, double-blinded, multicenter trial to determine the effectiveness of~     thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk~     compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C with early~     cirrhosis or progression to cirrhosis who are non-responders to previous treatment with~     interferon or interferon plus ribavirin. The definition of non-response requires a positive~     HCV RNA test at the end of a course of at least 12 weeks of therapy. Patients will receive~     treatment for 12 months, and will be followed-up for a further 6 months after the end of~     therapy~   "
270970|NCT00040261|"~     The purpose of this study is to determine the safety and effectiveness of the drug memantine~     for treating major depression.~      Major depression is a serious public health concern that contributes to significant morbidity~     and mortality. Despite the availability of a wide range of antidepressant drugs, a proportion~     of patients with major depression fail to respond to first-line antidepressant treatment,~     despite adequate dosage, duration, and compliance. Recent studies suggest that the~     glutamatergic system may play a role in the pathophysiology and treatment of depression.~     Memantine and other agents which reduce glutamatergic neurotransmission may represent a novel~     class of antidepressants.~      The study consists of three phases. In Phase 1, participants will be tapered off all~     psychiatric medications over a 2-week washout period. In Phase 2, participants will be~     randomly assigned to receive either memantine or placebo (an inactive pill) three times a day~     for 8 weeks. Participants who do not respond to the treatment after 8 weeks will be taken off~     the study and offered standard treatment. Weekly psychiatric evaluations will evaluate~     treatment response. During Phase 2, participants who respond well to treatment will enter~     Phase 3, a 16-week continuation phase of either memantine or placebo. Interviews will be~     conducted every other week in the first month , then monthly thereafter.~      Participants will have a physical examination, neuropsychological tests, and eye blink tests~     at baseline and at the end of the study. Pulse, blood pressure, and blood samples will be~     taken throughout the study. Participants will undergo an electrocardiogram as well as~     positron emission tomography (PET) and magnetic resonance imaging (MRI) scans of the brain.~   "
270971|NCT00040248|"~     This study will examine the safety and effectiveness of daclizumab (also called Zenapax or~     anti-CD25) in patients with Wegener's granulomatosis, a type of vasculitis (blood vessel~     inflammation). Wegener's granulomatosis can affect many parts of the body, including the~     brain, nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart, and~     other sites. Standard treatment is a combination of prednisone and a cytotoxic agent (a drug~     that interferes with cell growth), usually cyclophosphamide or methotrexate. However, many~     patients treated with this regimen have a disease relapse, and others cannot take these drugs~     because of severe side effects. This study will focus on the effectiveness of daclizumab in~     preventing disease relapse.~      The Food and Drug Administration approved daclizumab in 1997 for preventing kidney transplant~     rejection, and the drug has also been studied in people with an eye infection called uveitis.~     The drug works by binding to a protein on T lymphocytes (white blood cells of the immune~     system) called CD25. This prevents another protein, called interleukin-2, from binding to~     this site, thereby preventing a series of events that normally results in inflammation.~      Patients between 10 and 75 years of age with Wegener's granulomatosis may be eligible for~     this study.~      Participants will have a medical history review and physical examination, including~     laboratory studies. If medically indicated, x-rays, consultations and biopsies (surgical~     removal of a small tissue sample) of affected organs will also be conducted. All patients~     will begin treatment with prednisone and cyclophosphamide daily. Those who improve on this~     regimen will reduce the prednisone gradually and continue with cyclophosphamide until their~     disease is in remission. While taking cyclophosphamide, patients must have blood and urine~     tests done every 1 to 2 weeks. Those who achieve disease remission will stop cyclophosphamide~     and start taking methotrexate once a week, usually by mouth but possibly by injection into~     the muscle or skin. Blood and urine tests will be conducted once a week for 4 weeks while the~     dosage is being adjusted and then once a month for the duration of treatment. Patients on~     methotrexate whose prednisone dose is reduced to 10 to 30 mg every other day will be randomly~     assigned either to receive or not receive daclizumab in addition to the methotrexate.~     Daclizumab is given intravenously (through a plastic tube inserted into a vein) the day after~     the randomization, then again in 2 weeks, 4 weeks, and once a month for 18 months.~      All patients will continue to taper their prednisone dose until it is stopped. Methotrexate~     will continue for 2 years. Patients whose disease remains in remission at this time will~     decrease the methotrexate dose. If there is no active disease when both prednisone and~     methotrexate have been stopped, no further treatment will be given. If disease recurs at a~     later time, treatment will be reinstituted. The treatment will be determined by the severity~     of disease, other medical conditions, and history of side effects. Patients not randomized to~     daclizumab who relapse while still taking methotrexate may be offered re-treatment with~     daclizumab.~      Patients will be evaluated in the outpatient clinic every 4 to 8 weeks until randomization.~     Patients not taking daclizumab will be followed every 4 to 12 weeks; those taking the drug~     will be seen every 2 weeks for the first month, every month after that during the 18-month~     treatment period, and every 4 to 12 weeks until all medications stop. Follow-up evaluations~     include a physical examination, blood draws and, if medically indicated, X-rays. The total~     study duration is 60 to 70 months.~   "
270972|NCT00040235|"~     This study will determine whether magnesium replacement during apheresis can decrease side~     effects that donors commonly experience. Apheresis is a method of collecting large numbers of~     certain blood cells, such as white cells, stem cells, or platelets. In this procedure, whole~     blood is collected through a needle in an arm vein, similar to donating blood. The blood is~     separated into its components by centrifugation (spinning), the required cells are extracted,~     and the rest of the blood is returned to the body, either through the same needle or through~     another needle in the other arm.~      When healthy people donate cells by apheresis, a blood thinner called citrate is added to~     prevent the blood from clotting in the apheresis machine. Citrate works by reducing calcium~     in the blood. When the blood is returned to the donor, citrate from the machine is also~     returned, lowering the donor's calcium levels. As a result, donors often feel tingling around~     the mouth, hands, and feet. Some of these symptoms can be prevented by giving calcium~     intravenously (through a vein) during the procedure. Even with the added calcium, however,~     some donors still have symptoms. Magnesium levels are also lowered by citrate, but it is not~     known if this causes symptoms. This study will examine whether the decrease in magnesium~     levels also contributes to the side effects of apheresis and whether magnesium replacement~     can reduce these symptoms.~      Healthy apheresis donors 18 years of age or older who are enrolled in NIH protocols may~     participate in this study.~      Donors will undergo the apheresis procedures required by the NIH protocol they are enrolled~     in. Throughout the procedure, they will receive an intravenous infusion of a salt solution~     that may or may not contain magnesium. Blood samples of 5 milliliters (1 teaspoon) each will~     be taken from the apheresis machine at the beginning and end of the procedure and at 30- to~     60-minute intervals during the procedure. No more than 50 ml (3 tablespoons) will be taken~     during any single apheresis. The last sample will be drawn 60 minutes after completion of the~     apheresis. In addition, donors will:~        -  Provide a urine sample at the beginning and end of each apheresis procedure.~        -  Donate an additional urine sample and an additional 5 ml blood sample the morning after~          apheresis~        -  Describe any symptoms experienced during apheresis to the apheresis nurse~   "
270973|NCT00040222|"~     Individuals and families with known or suspected syndromes that include breast, ovarian or~     genetically-related cancers are enrolled in this family study, which is a syndrome-specific~     sub-set of the long-standing DCEG Human Genetics Program umbrella family studies protocol~     (78-C-0039). Cancer outcomes are documented through review of medical, vital, and pathology~     records. Selected individuals and family members are asked to complete questionnaires to~     assess etiologic risk factors and to undergo clinical evaluations specifically tailored to~     the relevant familial syndrome. Study participants are monitored prospectively for the~     development of outcomes of interest, typically by means of periodic mail or telephone~     contact. In selected instances, subjects may return to the Clinical Center periodically for~     study-specific follow-up examinations. Study participants are asked to donate biologic~     specimens to be used in the laboratory search for cancer etiology and mechanisms of~     carcinogenesis. DNA and serial serum samples will be collected. Tumor tissue will be obtained~     whenever feasible.~      Clinical genetic testing for tumor susceptibility gene(s) mutations and risk notification~     will be offered consistent with ASCO guidelines when reasonable individual cancer risk~     estimates can be delivered, and only to those participants who choose to know their~     individual genetic status after appropriate education and counseling. The testing will be~     conducted exclusively in Clinical Laboratory Improvement Amendments (CLIA)-licensed~     laboratories. Clinical genetic testing and risk notification are entirely optional and do not~     affect subject eligibility for other aspects of the protocol. A separate consent procedure~     and consent form will be used for genetic testing and risk notification.~      This protocol, developed in response to recommendations developed by the Clinical Center IRB,~     is intended to:~        1. Provide a mechanism under which the Clinical Genetics Branch can honor the commitment~          made to the members of over 60 hereditary breast/ovarian cancer families which have been~          participated in various Human Genetics Program research studies conducted over the past~          3 decades to provide genetic counseling,~           clinical germline mutation testing, and consultative services now that several of the~          major breast/ovarian cancer susceptibility genes have been identified;~        2. Provide a mechanism through which new families with various familial syndromes~          associated with an increased risk of breast and ovarian cancer can be studied, as~          research interests in these syndromes evolve over time; and~        3. Create a resource of well-characterized, carefully documented high-risk families to~          facilitate the development of new etiologic and translational research studies in the~          future.~      While we do not offer specific anti-cancer therapy as part of this protocol, we provide~     assistance to ensure that study participants who require treatment for problems that develop~     during the course of the study are referred to appropriate health providers. We~      remain available to provide advice and consultation related to the management of the familial~     cancer syndrome to study participants and their health care providers.~   "
270974|NCT00040209|"~     This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's~     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of~     long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect~     Parkinson's disease symptoms.~      Patients between 30 and 80 years of age with relatively advanced Parkinson's disease may be~     eligible for this 3-phase study.~        -  Phase 1 - Baseline evaluation~      Participants will be evaluated with a medical history, physical examination, detailed~     neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. They will~     also have a 24-hour holter monitor (heart monitoring) and cardiology consultation. A chest~     X-ray and MRI or CT scan of the brain will be done if needed. Patients will, if possible,~     stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before~     the study begins and throughout its duration. (If necessary, patients may use short-acting~     dopamine agonists, such as Mirapex and Requip.)~        -  Phase 2 - Dose Finding Phase~      For 2 to 3 days, patients will be admitted to the NIH Clinical Center for a levodopa (a~     dopamine agonist) dose-finding procedure. For this procedure, patients stop taking Sinemet~     and instead have levodopa, and subsequently apomorphine, infused through a vein. During the~     infusions, the drug dose is increased slowly until either 1) parkinsonian symptoms improve,~     2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms are~     monitored frequently to find the optimal dose. (Patients who have had dosing infusions in the~     last 3 months will not have to undergo this phase of the study.)~        -  Phase 3 - Active Study Phase~      Within 3 months of the dose-finding phase, treatment will begin. Patients will receive seven~     doses of JD-1730 or placebo (an inactive substance) via puffs from an oral spray together~     with levodopa infusions over a 3-week period. The doses are given on days 1, 2, and 3 of the~     first week and then approximately twice a week for the next 2 weeks. For these doses,~     patients are hospitalized 4 days the first week and 2 days each for the next 2 weeks. All~     participants will receive placebo at some time during the study, and a few patients, selected~     at random, will receive only placebo the entire 3 weeks. The procedure for the infusions is~     the same as that for the dose-finding phase, with frequent evaluation of symptoms. Also,~     small blood samples are drawn up to three times each study day. At the end of the third week,~     patients will be discharged from the hospital. Their anti-parkinsonian medications may be~     readjusted, as needed. Patients will be contacted 2 weeks after the end of the study for a~     check on side effects and, if necessary, will be scheduled for a follow-up evaluation at the~     clinic.~      In addition to the above procedures, patients will be asked to have an optional lumbar a~     puncture (spinal tap) on the first and last days of the study to measure various brain~     chemicals and drug levels that cannot be measured in blood and urine. For this procedure, a~     local anesthetic is given and a needle is inserted in the space between the bones (vertebrae)~     in the lower back. About 2 tablespoons of fluid is collected through the needle.~   "
270975|NCT00040196|"~     This study has two purposes: 1) to understand the effect of a decline of dopamine in the~     brain during normal aging and in patients with Parkinson's disease, and 2) to investigate how~     medicines used to treat Parkinson's disease improve movement performance in patients.~      Patients with Parkinson's disease have difficulty performing precise finger movements, mainly~     because of a dramatic decrease of a substance called dopamine in parts of the brain.~     Medicines such as levodopa, which help restore dopamine levels, can greatly improve function;~     however, little is known about how these drugs work. In normal aging, dopamine decreases~     slightly in certain parts of the brain, but the importance of this decline is poorly~     understood. This study may provide new information about Parkinson's disease and normal aging~     that might lead to better treatment strategies.~      Patients with mild to moderate Parkinson's disease and healthy volunteers 21 years of age and~     older may be eligible for this study. All participants must be right-handed. All candidates~     will be screened with a medical history and physical and neurological examinations, including~     memory tests and mood examination.~      Brain function will be studied using functional magnetic resonance imaging (fMRI) study and~     positron emission tomography (PET). Participants may be asked to stop using medications that~     can affect the central nervous system, such as sleeping pills or drugs for depression or~     anxiety, for 1 week before each study visit. Patients with Parkinson's disease may also be~     asked to stop using antiparkinsonian medications at least 12 hours before each visit. In~     addition, all participants will be asked to abstain from alcoholic beverages at least 24~     hours before the fMRI and PET scans, and from nicotine and caffeine for at least 12 hours~     before the scans.~      Participants will have fMRI, which uses a strong magnetic field and radio waves to create~     images of the brain. The subject lies on a table in a tunnel-like cylinder (the scanner) for~     1 to 2 hours, lying still for 5 to 15 minutes at a time. He or she can communicate with the~     technician or researcher at all times during the test through an intercom system. Scans will~     be done while the subject is at rest and while he or she is performing finger movements. The~     movements involve pushing five buttons on a box-each button every 3 seconds on average in a~     specific order. Patients with Parkinson's disease will be studied off- and then on-~     medications that restore the levels of levodopa in the brain.~      Some participants may be asked to undergo a PET scan on a separate visit. A PET scanner is a~     doughnut-shaped machine similar in appearance to a CT (computed tomography) scanner. PET~     scans detect radioactivity used to provide information on brain activity. Before the test~     begins, subjects are given a dose of carbidopa-a medicine that increases the amount of~     levodopa in the brain. A catheter (thin, plastic tube) is then inserted into an arm or wrist~     vein, and a radioactive form of levodopa called 18Fluorodopa is injected through the~     catheter. A moldable plastic mask with large openings for eyes, nose, and mouth is placed on~     the face to help keep the head still during scanning. The total scan time is 2 hours or less.~   "
270976|NCT00040131|"~     The purpose of this study is to determine if a single dose of IL-10 compared to placebo is~     safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects~     with increased risk.~   "
270977|NCT00040105|"~     The goal of this clinical research study is to find the highest safe dose of the drugs~     ZarnestraTM (R115777) and Gleevec (imatinib mesylate) that can be given in combination for~     the treatment of chronic myelogenous leukemia (CML) in chronic phase. The effect of this~     combination on the leukemia will also be studied.~   "
270978|NCT00040092|"~     Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's~     immune system, which in turn may slow the growth of tumors. It is presented in vials as a~     sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin~     in combination with gemcitabine provides better efficacy than gemcitabine alone (with~     placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if~     chemotherapy is changed to 5-Fluorouracil.~   "
270979|NCT00040014|"~     The purpose of this study is to find out if the two different formulations of exemestane~     (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and~     pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in~     postmenopausal women with metastatic breast cancer who have failed previous antiestrogens~     therapy and are equally safe.~   "
270980|NCT00040001|"~     This study is designed to evaluate the safety of DTI-0009 in patients with atrial~     fibrillation and to find the dose of DTI-0009 that lowers heart rates in patients with atrial~     fibrillation with rapid ventricular response.~   "
270981|NCT00039988|"~     The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone~     compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS).~      MS is thought to be an autoimmune disease of the central nervous system. Certain white blood~     cells of the immune system become abnormally active and mistakenly attack the myelin of nerve~     fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like~     insulation around an electrical wire. Without proper myelin insulation, messages sent between~     the brain and other parts of the body may be confused or fail completely. Damage to myelin~     causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR),~     where partial or total recovery occurs after attacks. Four therapies are currently approved~     for the treatment of MS. These therapies, however, are only moderately effective and can~     cause undesirable side effects. For this reason, there is a need to find new therapies that~     have minimal side effects and may stop the disease from getting worse.~   "
270982|NCT00039975|"~     Diltiazem CD and amlodipine are drugs used to treat heart disease and high blood pressure.~     The purpose of this study is to find out if these drugs interact with the anti-HIV drugs~     indinavir and ritonavir. The study will also look at the safety of taking the study drugs~     together.~      Heart disease and high blood pressure are major health concerns for people with HIV. Standard~     treatment for these illnesses often includes calcium channel blockers (CCBs). There is a~     potential for significant drug interactions between CCBs and HIV protease inhibitors (PIs)~     that may influence the dosing, monitoring, and choosing of CCBs and PIs when used in people~     infected with HIV. This study will examine the drug interactions between 2 commonly used CCBs~     and the PI combination indinavir and ritonavir (IDV/RTV). This information should help~     doctors choose the appropriate treatment for high blood pressure or heart disease in people~     taking PIs.~   "
270988|NCT00039923|"~     This study will examine blood cells of patients with paroxysmal nocturnal hemoglobinuria~     (PNH) after they receive a blood transfusion to determine if certain proteins (GPI-linked~     proteins) in the transfused blood transfer to the patient's blood cells. GPI-linked proteins,~     which are normally present on red cells and regulate red cell survival, are absent in~     patients with PNH. Their lack is believed to account for the premature destruction of red~     blood cells in these patients, resulting in a low hemoglobin and hematocrit. Patients may~     experience fatigue, flank pain and other symptoms, requiring treatment with blood~     transfusion.~      Patients with PNH 18 years of age or older with group A1 blood who require at least three~     units of red cells and who have not been transfused with group O blood within the last 3~     months may be eligible for this study.~      Participants will come to the NIH Clinical Center for the following procedures:~        -  Interview about the severity of their anemia-related symptoms~        -  Blood test~        -  Blood transfusion, if required. Patients will be transfused with compatible group O~          blood. The donor blood will be washed (rinsed with a salt solution) until it is 99% free~          of donor plasma. Group O blood is given instead of group A1 in order to be able to~          distinguish the patient's cells from the transfused cells.~      Blood samples of 3 teaspoons each will be drawn 1 day, 1 week, and 3 weeks after the~     transfusion. These samples may be collected by the patient's doctor locally and sent to NIH~     by mail.~      If it is found that GPI-linked proteins transfer to the patient's cells, the study will also~     examine how long the proteins remain attached and will assess whether the proteins are~     functional and prevent cell destruction.~   "
270989|NCT00039910|"~     Intensive chemotherapy is associated with significant thrombocytopenia, often requiring~     platelet transfusion to maintain platelet counts. This investigational drug has been~     demonstrated to increase platelet counts. This study will test the safety and efficacy of the~     investigational drug in the prevention of thrombocytopenia in patients with recurrent or~     refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL), or~     Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine, and Cisplatin)~     chemotherapy.~   "
270990|NCT00039884|"~     This is a clinical trial (a type of research study) designed to describe the efficacy~     (effectiveness) and toxicity (safety) of a new medical treatment, NESP (Novel Erythropoiesis~     Stimulating Protein). This study will be offered to patients with cervical cancer undergoing~     a combination of chemotherapy and radiation. This treatment may lower your red blood cells.~     The use of NESP may stimulate the body to produce more red blood cells. Our hypothesis is~     that higher red blood cells will be beneficial to the patient during treatment for cervical~     cancer.~   "
270991|NCT00039871|"~     The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus~     REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to~     severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha~     interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus~     REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the~     effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease~     progression (Protocols P02569 and P02570).~   "
270992|NCT00039858|"~     The purpose of this study is to evaluate the safe and effective dose of Argatroban for~     prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous~     diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who~     in the opinion of the investigator require alternative anticoagulation due to an underlying~     condition.~   "
270993|NCT00039845|"~     This study will use magnetic resonance imaging (MRI) to investigate language function in~     children-that is, how language skills such as naming objects, understanding spoken language~     and reading are organized in the brain. The study focuses on children between 4 and 7 years~     old. Children 8 to 12 years old and adults will be studied before the younger children to~     test study paradigms appropriate for pre-literate children. The results of this study will~     help evaluate the usefulness of MRI in identifying language function and location and may~     improve the treatment of children with seizures.~      Right-handed, native English-speaking adults and children between 4 and 12 years of age may~     be eligible for this study. Candidates will be screened with a routine neurological~     examination. Children will also undergo neuropsychological testing (standard tests of~     language, memory, perception and attention) either at the screening visit or at a later time.~     Parents will fill out a form to identify children with attention deficit and hyperactivity~     disorders. These children will be excluded form the study.~      All participants will undergo MRI scanning of the brain while performing a task designed to~     test a language skill, such as identifying a picture or listening to or reading a word. The~     MRI detects changes in blood properties in the areas of the brain that perform each task.~     Before the MRI, children will be rehearsed for the tests and will have a session in the~     scanner to know what to expect and feel more at ease during the actual test. The time in the~     MRI machine is usually between 15 and 20 minutes, but will be no more than 40 minutes for~     children 8 to 12 years old, and not more than 20 minutes for younger children. Children may~     be requested to have up to five MRI sessions to test different brain functions or confirm~     findings.~   "
270994|NCT00039832|"~     This study will evaluate the safety and effectiveness of two types of blood thinners,~     abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after~     ischemic stroke (stroke resulting from a blood clot in the brain).~      The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the~     clot buster drug rt-PA. This treatment, however, is effective only if begun within 3 hours of~     onset of the stroke and most patients do not get to the hospital early enough to benefit from~     it. There is thus a pressing need to develop effective stroke treatments that can be~     initiated more than 3 hours after onset.~      Patients between 18 and 80 years of age who have experienced a mild or moderate acute stroke~     between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates~     will be screened with a physical examination, blood tests and a magnetic resonance imaging~     (MRI) scan (if an MRI was not done during the stroke evaluation).~      All participants will receive ReoPro. Some will also receive Retavase, which may boost the~     effectiveness of ReoPro. Retavase is administered in a single dose through a needle in the~     vein over 2 minutes. ReoPro is infused into the vein over 12 hours. Patients will be~     monitored with physical examinations, blood tests, computed tomography (CT) scans, and three~     or four MRI scans of the brain to evaluate both the response to treatment and side effects of~     the drugs. An MRI scan will be done 24 hours, 5 days and 30 days after starting the study~     medication, and possibly during screening for this study.~      CT involves the use of specialized x-rays to obtain images of the brain. The patient lies~     still in the scanner for a short time while the X-ray images are formed. MRI uses a strong~     magnetic field and radio waves to demonstrate structural and chemical changes in tissue. MRI~     is more sensitive than x-ray in evaluating acute stroke. The patient lies on a table in a~     metal cylinder (the scanner) while the pictures are being taken. During part of the MRI, a~     medicine called gadolinium contrast is injected in a vein. This medicine brightens the~     images, creating better pictures of the blood flow.~   "
270997|NCT00039819|"~     This study will determine whether stimulating the nerves or the brain can modify the spinal~     reflex that controls the muscles that flex and extend the ankle. Training spinal nerve~     networks with sensory input may provide a way of re-establishing movements, such as walking,~     in patients with spinal injury.~      Healthy normal volunteers with no history of peripheral neuropathy or radiculopathy, ankle~     contractures or tendon surgery may be eligible for this study. Participants will undergo~     three stimulation procedures, each in a different session, to measure leg muscle reflexes.~     The procedures are:~        -  Reflex testing - Metal electrodes are taped to the skin over the leg muscles. A small~          electrical pulse is delivered through the electrodes to stimulate two nerves to the~          muscles. This evokes a reflex between the ankle flexor and extensor muscles. The~          responses to several dozen stimuli are averaged.~        -  Nerve stimulation - The nerve to the muscle that flexes the leg is electrically~          stimulated near the knee through electrodes taped to the skin. The strength of the~          stimulus is adjusted to produce little or no muscle movement. The stimulation is~          repeated every few seconds for 45 minutes.~        -  Transcranial magnetic stimulation - An insulated wire coil is placed on the subject's~          scalp. A brief electrical current passes through the coil, creating a magnetic pulse~          that travels through the scalp and skull and causes small electrical currents in the~          outer part of the brain. There may be twitching in the muscles of the arm or leg. During~          the stimulation, the subject may be asked to tense certain muscles slightly or perform~          other simple actions to help determine the best position for the coil over the part of~          the brain that controls the leg. The leg is then stimulated once every 10 seconds,~          combined with nerve stimulation every 1 to 2 seconds.~   "
270998|NCT00039754|"~     Multiple myeloma is a disease that resides primarily in the bone and has shown to be~     sensitive to radiation. Administration of a radiotherapy agent that targets the bone, such as~     Holmium-166-DOTMP, in conjunction with melphalan and an autologous stem cell transplant, may~     improve the patient's chance of responding to treatment. The purpose of this study is to~     determine the amount of Holmium-166-DOTMP that localizes in the bone and in normal organs,~     and to evaluate the safety and efficacy of Holmium-166-DOTMP in the treatment of patients~     with multiple myeloma.~   "
270999|NCT00039741|"~     Little is known about what treatment combinations are best for HIV infected children. This~     study examined the long-term effectiveness of different anti-HIV drug combinations in~     children and strategies for switching treatment if the first treatment does not work. The~     study enrolled children who had not previously taken anti-HIV medication. Participants in~     this study were recruited in the United States, South America and Europe.~      Some European children may also enroll in a substudy that will observe changes in body fat in~     children taking anti-HIV medications.~   "
271000|NCT00039767|"~     This study will compare the effectiveness of two blood thinners, heparin and lepirudin, in~     preventing withdrawal occlusion (blockage) in a venous access device (VAD). A VAD is a~     catheter (plastic tube) placed in a vein beneath the collarbone to deliver medication and~     withdraw blood samples during treatment. The device may become clogged, possibly by formation~     of a clot around the tip, blocking its opening and making it difficult or impossible to use.~     The clot can be dissolved by a medication called tPA. The blood thinner heparin has been used~     for many years to try to prevent the blockage from occurring, but it is still a problem in as~     many as 25 percent of VADs. This study will test whether a new blood thinner called lepirudin~     is more effective than heparin in preventing withdrawal occlusion caused by a small clot.~      Patients 21 years of age and older who are enrolled in NIH protocols at the Clinical Center~     and who require tunneled, open-ended VADs for their medical care may be eligible for this~     study. Candidates must expect to receive all of their primary medical care at the Clinical~     Center during the first 4 weeks after their VAD is inserted and most of their care at the~     Clinical Center for the next 3 months.~      Participants will be randomly assigned to receive either heparin or lepirudin flushes for the~     first 3 or 4 weeks after placement of their VAD-the period during which withdrawal occlusion~     is most likely to occur. After this period, all patients will use routine heparin flushes~     until the VAD is removed.~      The patient's VAD will be closely monitored for withdrawal occlusion during the 3- to 4-week~     test period and will continue to be observed for up to 3 months to check for lasting effects~     of the blood thinner.~   "
271001|NCT00039026|"~     This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on~     glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients~     will be randomized into one of two AC2993 treatment arms or to placebo treatment and will~     continue with their required existing diabetes medication (sulfonylurea) throughout the~     study.~   "
271002|NCT00039013|"~     This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on~     glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients~     will be randomized into one of two AC2993 treatment arms or to placebo treatment and will~     continue with their required existing diabetes medication (metformin) throughout the study.~   "
271003|NCT00039000|"~     The primary goal of this study is to determine if people with metastatic melanoma who receive~     Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live longer~     than people who may or may not have surgery but who receive conventional chemotherapy~     including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects~     in subjects who receive therapy with HSPPC-96.~   "
271004|NCT00038987|"~     To define the safety of vaccination with APSV as determined by the reactogenicity of the~     vaccine and the development of expected and un-expected adverse events associated with~     vaccination.~      To assess the proportion of individuals who respond to vaccination with a take (those who~     form a visible lesion at the injection site) 6 to 8 days after the vaccination.~   "
271005|NCT00038974|"~     This study is designed to test the hypothesis that African-Americans respond less well to~     combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have~     chronic hepatitis C genotype 1 and who were not previously treated with either interferon or~     ribavirin. Reasons for differences in response, regardless of race, will be studied.~   "
271006|NCT00038961|"~     This is a multicentre, randomized, double-blind, placebo controlled study. During this study~     all the patients will receive background venous thromboembolism (VTE) mechanical prophylaxis~     with intermittent pneumatic compression (IPC).~   "
271022|NCT00038844|"~     Objective of the low-dose transplant regimen must produce the following effects:~        1. Suppression of the patient's immune system to prevent rejection of the donor cells;~        2. Control of the lymphoma. The pretransplant regimen must suppress the lymphoma~          sufficiently to prevent marked progression of the tumor and allow time for the GVT~          effect to occur.~   "
271045|NCT00038532|"~     The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz~     in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first~     protease inhibitor based HAART.~   "
271007|NCT00039715|"~     The purpose of this study is to determine whether people who develop Post-Traumatic Stress~     Disorder (PTSD) after a trauma have increased sensitivity to the effects of a stress hormone.~      Patients with PTSD have small hippocampal volume and deficits in hippocampal-mediated memory~     as compared to healthy people. However, it is unclear whether the smaller hippocampi are a~     consequence of PTSD or a risk factor for the development of PTSD. Some researchers believe~     that people who develop PTSD have an increase in cortisol levels during traumatic experiences~     and that this could be neurotoxic to the hippocampus. Others hypothesize that increased~     sensitivity of glucocorticoid receptors to cortisol, regardless of the cortisol levels, could~     lead to neurotoxic damage to the hippocampus. This study will compare responses to a stress~     hormone in patients with PTSD, participants who have experienced trauma but do not have PTSD,~     and healthy volunteers.~      Participants will be screened with a medical and psychiatric interview, physical examination,~     blood tests, electrocardiogram, and an emotional intelligence evaluation. Those eligible for~     the study will be asked to collect urine and saliva samples for 3 days. Participation will~     also include blood draws, a PET scan (brain imaging), an eye-blink test, neuropsychological~     testing, and other procedures.~      At another study visit, participants will undergo a magnetic resonance imaging (MRI) scan~     (brain imaging), questionnaires, and other procedures.~   "
271008|NCT00039702|"~     The purpose of this study is to use brain imaging technology to examine the role of certain~     brain chemicals in individuals with Alzheimer's disease (AD) and in healthy volunteers.~      Cognitive dysfunction in people with AD is thought to arise from decreased chemical activity~     in specific parts of the brain. Decreases in alpha4beta2 nicotinic acetycholine receptors~     (nAChRs) have been found in the brains of people who died with AD; however, the status of~     this receptor system in living brains remains unclear. This study will use single photon~     emission computed tomography (SPECT) to study this receptor system in people with AD who have~     mild to moderate dementia and in healthy volunteers. In addition, this study will examine the~     relationship between cognitive dysfunction and nAChR deficits in the brains of individuals~     with AD.~      Participants with AD will have four clinic visits; healthy volunteers will have three visits.~     At Visit 1, participants will undergo a medical history, physical examination, and laboratory~     tests. Healthy volunteers will have a Mini-Mental State Examination (MMSE) cognitive function~     test. Participants with AD will have a MMSE and measurement of the severity of their~     dementia.~      During Visit 2, participants will undergo a magnetic resonance imaging (MRI) scan of the~     brain.~      At Visit 3, participants will undergo SPECT imaging.~      Only participants with AD will participate in Visit 4. During this visit, cognitive testing~     will be performed.~   "
271009|NCT00039689|"~     There is evidence that early and aggressive treatment with antiretroviral drugs can prevent~     the loss of immune cell function that accompanies HIV infection. This study will use~     leukapheresis (drawing blood, separating out the white cells and returning the blood to the~     patient) to obtain blood cells from HIV-infected patients in either the acute or chronic~     stage of infection who are being treated with early highly active antiretroviral therapy~     (HAART). Leukapheresis is necessary to obtain enough cells to delineate the response of B~     cells to CD4+ T cell help, the CD8 factors associated with suppression of viral replication~     and normalization of immune function, and natural killer function relative to HIV disease.~      Study participants will be adult (older than 18 years) HIV primary or acutely affected~     patients (those with a history of exposure to HIV but not yet showing chronic symptoms of HIV~     disease) and HIV chronically infected patients (those infected with HIV for longer than 12~     months or showing other symptoms of HIV disease) who are not receiving HAART at the beginning~     of the study. The study seeks to enroll 30 primary and 30 chronic patients. Pregnant women~     will not be enrolled in the study; women who become pregnant will be dropped from the study.~      Leukapheresis will be performed on each patient before HAART therapy begins and then three~     times a year. Each session will take between 1 and 3 hours.~      This longitudinal study will enable researchers to examine the function of certain B cells,~     natural killer cells, and CD8+ T cells in people who do not have chronic HIV disease and in~     those who do have the disease and are treated with HAART.~   "
271010|NCT00039676|"~     Background:~        -  Individuals may be prone to develop blood or lymph node cancers (leukemia or lymphoma)~          for a variety of reasons, including genetic predisposition to these cancers,~          environmental exposures or other medical conditions.~        -  Studies of people and families at high risk of cancer often lead to clues about their~          cause that may also be important regarding the sporadic occurrence of these cancers in~          the general population.~        -  Identifying genetic or environmental factors that play a role in the development of~          these diseases may be important in developing prevention trials, screening programs and~          treatments.~      Objectives:~        -  Describe the cancers and other conditions in families with blood or lymph node cancer.~        -  Find and describe genes that may cause blood and lymph node cancer, and understand how~          they work in families.~        -  Use laboratory methods to try to determine if it is possible to identify who is at~          highest risk of blood or lymph node cancer.~        -  Test how genes act with other factors to alter the risk of disease, its severity or its~          manifestations in families.~      Eligibility:~        -  Individuals of any age with a personal or family history of a blood or lymph node~          cancer.~        -  Individuals with a personal or family history of medical conditions or environmental~          exposures that may predispose to blood or lymph node cancer.~      Design:~        -  Participants complete questionnaires about their personal and family medical history and~          provide consent for researchers to review their medical records and pathology materials~          related to their care and those of deceased relatives with blood or lymph node cancer,~          tumors, or other related illnesses for whom they are the legally authorized~          representative.~        -  Participants donate a sample of blood or cheek cells, or a lock of hair for genetic~          studies.~        -  Patients may also be evaluated at the NIH Clinical Center by one or more of the~          following specialists: cancer doctor or blood specialist, medical geneticist, research~          nurses or clinical social worker. They may have blood and urine tests and a cheek swab~          or mouth wash to collect cheek cells. Some patients may also be asked to have x-rays and~          routine imaging, such as CT scans or ultrasound tests, cell surface markers, skin~          biopsy, and, with special consents, bone marrow biopsy, MRI or PET scans, apheresis or~          fluorescein angiography and photography.~   "
271023|NCT00038831|"~     The goal of this clinical research study is to find the highest safe dose of Mylotarg that~     can be combined with chemotherapy in patients receiving allogeneic bone marrow~     transplantation. Researchers will study the effects of this treatment combination on patients~     with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome.~      Primary Objective:~      1. To determine the safety and maximum tolerated dose of Mylotarg as part of a~     reduced-intensity preparative regimen patients undergoing related, mismatched-related or~     matched unrelated donor transplantation.~      Secondary Objectives:~        1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with~          this strategy.~        2. To evaluate the incidence and severity of GVHD in this population~        3. To evaluate disease-free and overall survival and relapse rates.~   "
271046|NCT00038519|"~     The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or~     saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second~     protease inhibitor based HAART.~   "
271011|NCT00039663|"~     Highly active antiretroviral therapy (HAART) has proven effective in altering the natural~     history of HIV infection in many patients. However, this therapy may not be sustainable~     because of the toxicities of the medications. Evidence suggests that HIV-infected patients on~     HAART may be at risk for premature coronary artery disease. The exact cause is unknown. It is~     possible that the medications directly affect the endothelium (the lining of the arteries~     that supply blood to the heart) and lead to premature heart disease. Or because the~     medications cause lipid abnormalities (high cholesterol) and a condition of relative insulin~     resistance, in which the body has a difficult time processing sugars; known risk factors for~     endothelial dysfunction and heart disease. Therapeutic intervention that reverses these lipid~     abnormalities and/or insulin resistance may lower these risk factors, normalize endothelial~     function, and decrease the risk of heart disease.~      This protocol aims to assess endothelial function among a group of HIV-infected patients with~     varying degrees of viral activity and levels of immune function on a variety of HAART~     regimens. It also aims to evaluate the effect of three different medications on lipids,~     insulin resistance, and thus endothelial function. Understanding the factors involved in~     causing endothelial dysfunction will help better characterize the relative risks and benefits~     of early versus late and continuous versus intermittent HAART therapy. The research may offer~     some insights into the causes of premature heart disease among HIV-infected patients on HAART~     that could be more thoroughly investigated in subsequent clinical trials.~      A total of 75 patients will be recruited: 25 for each arm of the study. Each arm evaluates~     the potential benefit of a particular medication and will enroll sequentially. An endothelial~     function test will be performed on an outpatient basis. The first 25 patients will be~     assigned at random to receive pravastatin sodium or placebo; the next 25 will receive~     gemfibrozil or placebo; the final 25 will receive rosiglitazone or placebo. Patients will~     take the pills for 6 weeks, no pills for the next 4 weeks, and then the opposite treatment~     for 6 more weeks. Two weeks after the start of the study drug, blood will be taken to check~     for potential toxic side effects. After each 6-week treatment, blood will be drawn and~     endothelial function tests will be performed.~   "
271012|NCT00039650|"~     This study will evaluate changes in T cells-infection-fighting white blood cells of the~     immune system-in people given a drug called G-CSF before donating stem cells (immature bone~     marrow cells) for transplantation. Originally, bone marrow cells were obtained using a needle~     inserted into the hipbone of the donor. However, when it was discovered that immature bone~     marrow cells also circulate in the blood, scientists began to develop techniques to collect~     quantities of these cells from the blood instead of the bone. G-CSF is a blood cell growth~     factor that pushes stem cells from the bone marrow into the bloodstream. Stem cell donors are~     given this drug 5 to 6 days before donation to make more cells available in the circulating~     blood for collection.~      Stem cell transplantation requires careful regulation of immune cell function to allow the~     donated stem cells to grow in the transplant recipient, to prevent the transplanted cells~     from damaging the recipient, and to allow the recipient's new immune system to develop~     normally so it can fight infections. Studies comparing the outcome of patients transplanted~     with bone marrow cells with those transplanted with stem cells suggest that the G-CSF given~     to stem cell donors affects the function of T cells in transplant recipients. This study will~     collect white cells containing T cells before and after G-CSF administration to determine the~     effects of the drug on both T cells and stem cells.~      Healthy normal volunteers 18 years of age and older who meet the health criteria for donating~     blood may participate in this study. Pregnant and breastfeeding women are not eligible.~      Participants will undergo the following procedures:~        -  Blood sample collection (15 milliliters, or 3 teaspoons) to measure blood cell counts~        -  Electrocardiogram to assess heart function~        -  Apheresis to donate white blood cells. Participants will undergo two apheresis~          procedures-once before receiving G-CSF and a second time immediately after finishing the~          5-day course of the drug. For this procedure, whole blood is removed using a needle~          placed in an arm vein. The blood is circulated through a cell separator machine, where~          the white cells are removed and collected in a plastic bag. The rest of the blood,~          including the red cells, platelets, and plasma, are returned to the donor through a~          needle in the other arm. The procedure takes 2 to 3 hours, during which time the donor~          lies quietly.~   "
271013|NCT00039624|"~     This study will evaluate the use of magnetic resonance imaging (MRI) for guiding placement of~     hollow needles into the prostate gland for delivering internal radiation therapy to patients~     with prostate cancer. Prostate cancer is often treated with a combination of external beam~     radiation therapy and brachytherapy (internal radiation delivered close to the tumor). This~     study will determine whether MRI is more accurate in guiding needle placement than~     ultrasound, which is currently used for this purpose. Patients will have one brachytherapy~     treatment followed by 5 weeks of external beam treatments and a second brachytherapy.~      Patients 18 years of age and older with prostate cancer that has not spread to the bone may~     be eligible for this study. Candidates will be screened with a physical examination, blood~     and urine tests, and a bone scan.~      To plan for radiation therapy, patients will have standard computed tomography (CT) and MRI~     scans of the pelvis and prostate. In addition, CT and MRI scans will be done to determine if~     the prostate is in a good position for brachytherapy. For these scans, patients will have an~     enema and a tube will be placed in the rectum. They will then lie still on their side for~     about 45 minutes during the scan. Patients who have blood in their urine will also undergo~     cystoscopy. This is an examination of the bladder using a small camera that is advanced~     through the penis into the bladder.~      Patients are given an antibiotic for 2 days before the brachytherapy and on the morning of~     the procedure. Before the test, they have a small enema and are given medicines through the~     vein and into the spine for relaxation and to decrease any discomfort. (The test is done~     under general anesthesia for patients who require it.) The patient is moved on a stretcher~     into the MRI scanner and a catheter is inserted into the bladder through the penis. The~     bladder is filled with water and a tube is placed in the rectum. With the help of a plastic~     guide placed against the skin, about 14 to 18 needles are then placed in the prostate. Some~     stitches are sewn to hold the needles and the guide in place, and the tube in the rectum is~     removed. The patient is the transferred from the MR scanner into the CT scanner, where the~     rectal tube is reinserted and the needles are adjusted. A cystoscopy is done to make sure the~     needles do not enter the bladder. When the needles are adjusted, the tube is removed from the~     rectum and the patient is moved to the radiation oncology clinic.~      After a few hours, when the radiation dose has been calculated, a radioactive substance~     called iridium is administered. The needles placed in the prostate are connected to a~     radiation machine, and thin wires with radioactive material on the tips are inserted into~     each needle and withdrawn a little at a time. The process takes about 20 to 30 minutes. The~     patient is then disconnected from the machine and undergoes another MRI scan to confirm the~     position of the needles. The needles and catheter are then removed and the patient is~     monitored for a while before going home. Patients then have 5 weeks of external beam therapy,~     followed by a second brachytherapy treatment.~      Patients return to the clinic at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment~     for blood tests, physical examination, and review of symptoms.~   "
271014|NCT00038948|"~     The purpose of this study is to determine the effect of conversion from calcineurin inhibitor~     to sirolimus based therapy on renal function.~   "
271015|NCT00038935|"~     The purpose of this study is to determine the relative bioavailability of ReFacto AF as~     compared to ReFacto, when each is administered as 2-minute bolus infusions.~   "
271016|NCT00038922|"~     To explore the safety of orally delivered rhIL-11 in patients with mild to moderate~     left-sided ulcerative colitis.~      To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples~     and in colonic biopsy tissue samples.~   "
271017|NCT00038909|"~     To identify the causative mutations in previously untreated patients with hemophilia A~     enrolled in the ReFacto® clinical safety and efficacy study CTN 93-R833-0XX/C9741-28, using~     two established hemophilia mutation testing laboratories (one in Europe and one in North~     America).~   "
271018|NCT00038896|"~     The primary objective of this study is to determine the efficacy, safety, and tolerability of~     a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in~     the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III~     study.~   "
271019|NCT00038883|"~     High dose chemotherapy followed by transplantation of allogeneic hematopoietic stem cell with~     the use of Campath-1h, a monoclonal antibody that have a synergistic effect to chemotherapy~     with minimal toxicity. In addition Campath-1H can improve engraftment of donor cells through~     its immunosuppressive properties.~   "
271020|NCT00038870|"~     1. Determine the feasibility of generation of autologous Acute Myelogenous Leukemia (AML)~          or Chronic Myelogenous Leukemia in myeloid blast crisis (CML/BC) derived dendritic cell~          activated lymphocytes (DC/AL) in poor prognosis patients.~        2. Determine the toxicity of autologous leukemia derived dendritic cell activated~          lymphocytes (DC/AL) in patients with AML or CML/BC.~        3. Quantitate circulating immune effector cells in patients after infusion of DC/AL.~        4. Record the efficacy of AML or CML/BC derived dendritic cells and activated lymphocytes~          in promoting and sustaining remission in patients with AML or CML/BC.~   "
271047|NCT00038506|"~     This study is a 48-week study to evaluate the efficacy and safety of an investigational~     regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on~     their first highly active antiretroviral therapy regimen.~   "
271024|NCT00038818|"~     Primary Objectives:~      To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8~     depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic~     leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple~     Myeloma (MM) and Hodgkin's Lymphoma (HD).~      Secondary Objectives:~        -  To evaluate safety and treatment related mortality after CD8 depleted DLI.~        -  To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.~        -  To evaluate the incidence and timing of pancytopenia following DLI.~        -  To evaluate disease-free survival, overall survival and relapse rates in three cohorts~          of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD,~          CLL, NHL and MM).~        -  To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte~          infusions.~        -  To evaluate the number of apheresis procedures needed to collect appropriate doses of~          CD4+ cells.~   "
271025|NCT00038805|"~     Primary Objective:~      To determine the safety and maximum tolerated dose of CMA-676 as part of an intensive but~     nonmyeloablative preparative regimen in older or medically infirm patients undergoing~     mini-allogeneic peripheral blood stem cell transplantation~      Secondary Objectives:~        1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with~          this strategy.~        2. To evaluate disease-free and overall survival and relapse rates.~        3. To evaluate the need and ability to give multiple cycles of Mylotarg plus FA and~          mobilized DLI in patients not achieving complete remission.~   "
271026|NCT00038792|"~     Phase II efficacy evaluation, phase I/II efficacy and toxicity trial of recombinant human~     keratinocyte growth factor for the treatment of steroid refractory gastrointestinal graft~     versus host disease.~   "
271027|NCT00038779|"~     The purpose of this study is to assess early treatment failure within 100 days and to assess~     the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and~     survival.~   "
271028|NCT00038766|"~     The purpose of this study is to determine whether CNI-1493 is safe and effective in the~     treatment of moderate to severe Crohn's Disease.~   "
271029|NCT00038753|"~     To identify vision-screening tests that can accurately predict those three- and four-year old~     preschoolers who would benefit from a comprehensive vision examination because of signs of~     amblyopia, strabismus, and/or significant refractive error.~   "
271030|NCT00038727|"~     The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an~     intensive lifestyle or metformin to prevent or delay the development of diabetes in a high~     risk population due to the presence of impaired glucose tolerance (IGT). The DPP has ended~     early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced~     diabetes onset by 31%.~      DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable~     DPP participants. This group of participants is nearly 50% minority and represents the~     largest IFG/IGT population ever studied. Clinically important research questions remain that~     focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course~     of precisely known new onset diabetes, in particular regarding microvascular disease, CVD~     risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in~     minority populations.~      The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of~     the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and~     high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend~     annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on~     cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and~     import.~   "
271031|NCT00038714|"~     Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and~     can obstruct the airway or become malignant. The cause has been related to specific types of~     Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness~     of a trial drug, SGN-00101, in children with RRP and also assess its safety.~   "
271032|NCT00038701|"~     The goal is to assess survival and patterns of failure in patients treated with Gemzar-based~     chemoradiation and TNP-470 for locally advanced adenocarcinoma of the pancreas.~   "
271033|NCT00038688|"~     Injection drug use is the major mode of HIV transmission in many countries. Injection drug~     users (IDUs) transmit HIV not only through shared drug injection equipment but also through~     heterosexual and homosexual transmission and mother-to-child transmission. Studies have shown~     that peer education programs can reduce HIV risk behavior in IDUs. However, it is not known~     if reduced HIV risk behavior leads to fewer HIV infections. The purpose of this study is to~     find out if a peer education program can reduce the number of new HIV infections by changing~     the behavior of IDUs and their HIV risk contacts.~   "
271034|NCT00038675|"~     The goal of this clinical research study is to see if Gleevec, known as imatinib mesylate~     (STI571), can improve the disease condition in patients with hypereosinophilic syndrome,~     polycythemia vera, atypical CML or CMML with PDGF-R fusion genes, or mastocytosis.~   "
271035|NCT00038662|"~     The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study~     is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as~     measured by rate of rise in the PSA (primary objective).~   "
271036|NCT00038649|"~     The goal of this clinical research study is to see if higher doses of imatinib mesylate~     (Gleevec, STI571) can improve chronic myelogenous leukemia (CML) in chronic phase.~   "
271037|NCT00038636|"~     The purpose of this study is to determine the safety and effectiveness of a high dose of~     ABT-378/ritonavir~   "
271038|NCT00038623|"~     Study of Yttrium-ibritumomab (Zevalin) For the treatment of Patients with Relapsed &~     Refractory Mantle Cell Lymphoma~   "
271039|NCT00038610|"~     The goal of this clinical research study is to learn if intensive chemotherapy, combined with~     imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by~     maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate~     indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of~     this treatment will also be studied.~   "
271040|NCT00038597|"~     The goal of this research is to see if giving the drug SCH66336 by mouth can improve the~     disease in patients with chronic or accelerated phase CML. The safety of this treatment will~     also be studied.~   "
271048|NCT00038493|"~     This study will combine the chemotherapy agent temozolomide with the investigational drug~     SCH66336 (an agent which interferes with new cell growth). Patients will be treated with oral~     temozolomide on days 1-5 and oral SCH66336 on days 8-28 every 28 days.~   "
271049|NCT00038480|"~     The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe~     and well tolerated in HIV infected infants. This study will also determine the most effective~     dose of LPV/RTV for infants.~   "
271050|NCT00038467|"~     To compare the sequential administration of exemestane with administration of further~     tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already~     received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall~     survival (OS), incidence of contralateral breast cancer and long-term tolerability.~   "
271051|NCT00038454|"~     To evaluate the efficacy of Hemolink™ in combination with Intraoperative Autologous Donation~     (IAD) versus control (IAD alone) in facilitating avoidance of allogeneic RBC transfusion~     during and following primary CABG surgery~   "
271052|NCT00038441|"~     This is a clinical research study of a new investigational treatment for cancer called~     DTI-015 to be given by intratumoral injection. Intratumoral injection is when drug is~     injected directly into the tumor. This study will help doctors find out what is the best dose~     level for DTI-015 and if this treatment can shrink tumors without causing severe side~     effects. The effects of the drug on the patient's quality of life (how the patient feels and~     what the patient can do) and their mental functions (reasoning and thinking abilities) will~     also be studied.~   "
271053|NCT00038428|"~     The purpose of this study is to determine the effectiveness and safety of TLK286 given~     intravenously once every week in the treatment of patients with advanced ovarian cancer that~     is resistant to platinum-based chemotherapy.~   "
271054|NCT00038415|"~     The goal of this clinical research study is learn if a vaccine that contains the patient's~     own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia~     (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine~     will be studied. This is a dose escalation study in which each patient will receive vaccine~     at one dose level. Patients will be injected with a fragment of Deoxyribonucleic acid (DNA)~     containing the sequence of their own immunoglobulin gene. Patients will be required to have~     their diagnosis of CLL and stage confirmed prior to initiating vaccination. After vaccination~     patients will receive clinical and immunologic evaluation, including both humoral and~     cellular responses. The investigator will be assessing the patient's immune response or~     whether the patient's body recognizes the DNA vaccine. In addition, side effects and~     reactions to the vaccine will be evaluated.~   "
271055|NCT00038402|"~     The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy~     treatment of patients newly diagnosed with operable breast cancer.~      Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the~     tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of~     this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side~     effect profile with the addition of Herceptin, and 4) evaluate significance of HER2~     expression by two different methods.~   "
271056|NCT00038389|"~     It is of interest to determine whether COX-2 inhibitors given with radiation therapy can~     prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas~     are more common in children, but are also seen in adults. However, the use of commercially~     available COX-2 inhibitors has not been evaluated in the pediatric population and the proper~     dosing in pediatrics is unknown. Therefore a Phase I study will need to be conducted as a~     first step. Rofecoxib is an FDA approved COX-2 inhibitor for use in adults. This phase I~     study is designed to determine the maximum tolerated dose of Rofecoxib given concurrently~     with standard radiation therapy for diffuse pontine brainstem glioma.~   "
271057|NCT00038376|"~     The purpose of this study is to determine the response rate of patients with T-cell~     malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin~     (Accutane).~   "
271058|NCT00038363|"~     The proposed study objective is to compare hospital-based rehabilitative care with~     transitional subacute rehabilitation for adults recently diagnosed with a disabling disorder.~     Clinical outcomes, cost and utilization of services will be compared in order to test the~     hypotheses that medically-stable patients receiving rehabilitation from subacute care~     facilities will: 1) function as well physically, 2) report less family dysfunction, 3) have~     better psychological adjustment and well-being than controls who receive only hospital-based~     inpatient care, and 4) receive services at lower cost. We intend to assess the impact of~     hospital-based versus subacute care on clinical and cost outcomes at admission, discharge [3~     months post-admission] and at 12 months. The first set of analyses will determine predictors~     of physical function, family function, psychological adjustment and well-being over a 1 year~     period.~   "
271059|NCT00038350|"~     The long-term goal of this research program is to advance the treatment of swallowing~     disorders in elderly adults. This study will identify the impact of an 8-week progressive~     resistance exercise program for oral muscles on swallowing physiology, anatomy, dietary~     intake, and Quality of Life (QOL) in frail dysphagic adults. Findings from the exercise~     program may indicate new directions for treatments and techniques designed to influence the~     biological underpinnings of dysphagia in elderly persons. Translation of these findings into~     clinical practice will have far-reaching significance in the fields of gerontology, speech~     language pathology, and long-term care.~   "
271060|NCT00038337|"~     The objective of this two parallel component study is to develop interventions for the visual~     and cognitive related health literacy disabilities of older veterans. The first component~     will test two interventions for improving functional health literacy performance (enhancing~     the design of health literacy materials and training reading skills) by using a 2 x 2 between~     subjects factorial design. The second component consists of patient, family, and provider~     focus groups who will help determine where to apply and disseminate the interventions by~     identifying problematic sources of text-based health materials. Finally, as a result of both~     components improved health information design guidelines and training protocols will be~     developed as rehabilitative interventions for health literacy disability.~   "
271146|NCT00037297|"~     To locate and identify genes contributing to the genetic component of subclinical~     cardiovascular disease (CVD) in Type 2 diabetes and to evaluate the impact of lifestyle and~     environment on the expression of these genetic components of subclinical CVD.~   "
271061|NCT00038311|"~     Intensive chemotherapy is associated with significant thrombocytopenia, often requiring~     platelet transfusion to maintain platelet counts. This investigational drug has demonstrated~     the ability to increase platelet counts. This study will test the safety and efficacy of an~     investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma~     receiving AI (Adriamycin/Ifosfamide) chemotherapy.~   "
271062|NCT00038298|"~     This clinical study is investigating AMG 719, an investigational drug, for the treatment of~     patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug~     which is self-injected beneath the skin (similarly to the way insulin is self-injected by~     diabetics). Patients on this study are on study for 28-weeks. They visit the study facility~     at least 11 times while participating in the study.~   "
271063|NCT00038285|"~     In the VA, we are achieving progress in decreasing amputation rates through early~     identification and multidisciplinary treatment of patients at risk for limb loss. Despite~     these accomplishments, however, clinical outcomes post-amputation, especially for PVD~     patients, have changed little because of patients' poor cardiovascular condition complicated~     by the injurious consequences of imposed inactivity begun in the preoperative period and~     continuing through convalescence. If not aggressively managed throughout all phases of~     recovery, these problems quickly render patients, already at risk, incapable of the rigors of~     rehabilitation as well as lead to reamputation, rehabilitation failure, and secondary~     complications. In our research, we are trying to transform this clinical scenario by applying~     what has succeeded in cardiac rehabilitation to services provided to amputees. In a series of~     studies, we are studying how to incorporate secondary CV risk factor modification and~     aggressive exercise interventions into conventional amputation rehabilitation through a~     program that we have named Healthy Heart Amputation Rehabilitation Therapy (Healthy~     H.A.R.T.). Our goal is to better: 1) increase aerobic capacity and promote rehabilitation~     achievements and quality of life, and 2) prevent postoperative complications and curtail~     further peripheral vascular deterioration through interventions found successful in cardiac~     rehabilitation. The basic assumption of this study will be that cardiovascular status and,~     thus, aerobic capacity is a most critical factor for rehabilitation success.~   "
271064|NCT00038272|"~     The purpose of this study is to evaluate the safety, efficacy, and side effects of~     beta-D-2,6-diaminopurine dioxolane (DAPD) compared to DAPD plus mycophenolate mofetil (MMF)~     when these drugs are added to the anti-HIV treatment regimens of people infected with HIV.~      Some studies have shown that DAPD and MMF can help fight HIV. However, neither DAPD nor MMF~     has been approved by the Food and Drug Administration for treating HIV infection. This study~     will help doctors decide if DAPD and MMF are good drugs for treating HIV.~   "
271065|NCT00038259|"~     When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral~     load rises and the body's immune system is exposed to more HIV. This may lead to the body~     mounting a better immune response against the virus. The purpose of this study is to find out~     if taking interleukin-2 (also called IL-2 or aldesleukin) while stopping anti-HIV drugs for~     short periods of time can help patients control their HIV viral load.~      Study hypothesis: Patients in this study will have lower virologic rebound and will maintain~     their CD4 cell counts for a longer time than other patients in comparative studies.~   "
271066|NCT00038246|"~     The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all~     chemotherapy drugs used in shrinking the cancer.~   "
271067|NCT00038233|"~     The objective of this protocol is to assess therapeutic activity of thalidomide in previously~     untreated patients with asymptomatic multiple myeloma.~   "
271068|NCT00038220|"~     The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the~     growth of HIV in patients infected with the virus.~   "
271069|NCT00038207|"~     The goal of this clinical research study is to learn if treatment with the drug liposomal~     vincristine can shrink or slow the growth of the patient's cancer. The safety of this drug~     will also be studied.~   "
271070|NCT00038194|"~     The goal of this clinical research study is to find the highest safe dose of docetaxel in~     combination with Gleevec (imatinib mesylate) that can be given to men with advanced~     androgen-independent metastatic prostate cancer that involves bone. Docetaxel is a commercial~     chemotherapy which interferes with the cancer cell ability to divide and grow.~   "
271071|NCT00038181|"~     The goal of this clinical research study is to find out whether it is safe to treat patients~     diagnosed with locally advanced prostate cancer with the drug Thalidomide before removing the~     tumor (radical retropubic prostatectomy).~      Researchers also want to learn if Thalidomide can shrink or slow the growth of the prostate~     cancer before the surgery~   "
271072|NCT00038168|"~     Phase I: The goal of this clinical research study is to find the highest dose of estramustine~     phosphate administered intravenously in combination with a fixed dose of Taxol (paclitaxel)~     that can be given safely to participants with prostate cancer who have failed to further~     benefit from hormone treatment.~      Phase II: The goal of this clinical research study is to find out if the combination of the~     drugs estramustine phosphate and paclitaxel will shrink or control prostate cancer that has~     not responded to hormone treatment. A second goal is to find out if the side effects of these~     drugs can be reversed. The safety of these drugs will also be studied.~   "
271073|NCT00038155|"~     Hospitalization for an acute medical condition often results in functional decline in older~     adults. This loss of function often is not reversed after hospital discharge. Our general~     hypothesis is that patients will benefit from rehabilitation that occurs simultaneously with~     the medical management of acute conditions and when linked with a home exercise program that~     can be implemented after discharge from the hospital. This approach differs from the~     traditional approach of addressing rehabilitation needs after acute conditions have resolved~     and providing rehabilitation services for selected patients in institutional settings, such~     as subacute units or nursing homes. The feasibility of the program will be assessed by~     documenting the participation of subjects during the inpatient phase and adherence of~     subjects with the home-based program. Fifty subjects will be recruited from individuals who~     are 60 years of age or older who have been admitted to the Birmingham Veterans Affairs~     Medical Center (VAMC) for treatment of an acute medical condition. Subjects will be either~     unable to ambulate, require assistance for ambulation, or be unable to ambulate a functional~     distance (150 feet) at a functional velocity (30m/min). Subjects will be randomly assigned to~     a physical rehabilitation group (PR) or to a control group (CON). During hospitalization,~     subjects in the PR group daily will have one 45-minute morning rehabilitation session and one~     30-minute evening rehabilitation session. Both sessions will include ambulation and transfer~     training. The longer morning session will also include resistance exercise. Subjects in the~     CON group will have medial care as it is currently provided. During the six months after~     discharge, subjects in the PR group will perform a home-based exercise program consisting of~     ambulation and resistance exercises. The program will be monitored and progressed by an~     exercise physiologist who will visit subjects weekly for the first month after discharge,~     every other week for the second and third months after discharge, and monthly in the fourth,~     fifth, and six months after discharge. This study is designed to test the feasibility and~     effectiveness of a practical and potentially cost-effective rehabilitation program.~   "
271074|NCT00038142|"~     Objectives:~        1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and~          Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free~          survival seen with standard VAC therapy.~        2. To evaluate the feasibility and describe the toxicity associated with VACdxr.~        3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a~          weekly basis for 50- 52 weeks.~        4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.~   "
271075|NCT00038129|"~     The purpose of this study is to determine if there is a difference in the rate of healing of~     a tibia fracture treated with an intramedullary nail based on whether or not the bone was~     reamed prior to nail insertion.~   "
271076|NCT00038116|"~     The purpose of this trial is to determine if patients who received embryonic dopamine cell~     implant surgery showed significantly greater improvement in their Parkinson's disease than a~     control group undergoing the placebo treatment, and to determine if the cell implant surgery~     was more effective in younger or older patients.~   "
271077|NCT00038103|"~     This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either~     exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on~     tamoxifen.~   "
271078|NCT00038090|"~     Objective is to assess the activity of the combination of thalidomide and dexamethasone in~     patients with previously untreated multiple myeloma.~   "
271079|NCT00038077|"~     The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in~     asymptomatic heart failure subjects will improve their heart structure and thus prevent the~     progression to symptomatic disease.~   "
271080|NCT00038064|"~     Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red~     blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and~     shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone~     marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in~     the laboratory and has the same effect as the hormone produced by the body. Use of~     recombinant human erythropoietin allows the body to produce more red blood cells, possibly~     eliminating or decreasing your symptoms and the need for a red blood cell transfusion.~     Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving~     chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for~     the treatment of anemia in patients with non-myeloid malignancies who are receiving~     multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that~     stimulates the production of red blood cells. This medication has not been approved to treat~     cancer patients with anemia, however it has been approved by the FDA to treat chronic renal~     failure patients with anemia.~   "
271081|NCT00038051|"~     The goal of this clinical research study is to find the highest safe dose of the anti-CD33~     immunotoxin HuM-195/rGel that can be given to patients with advanced myeloid malignancies.~     This treatment will be given to patients whose leukemia has not responded to prior~     chemotherapy.~   "
271082|NCT00038038|"~     The purpose of this clinical research study is to answer the following questions using~     18F-fluoromisonidazole as an imaging agent:~        1. Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)?~        2. If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to~          control human tumors?~        3. Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?~   "
271083|NCT00038025|"~     The purpose of this study is to determine the side effects and antitumor response of patients~     with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.~   "
271084|NCT00038012|"~     A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with~     ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin~   "
271085|NCT00037999|"~     The objective of this project is to determine the safety and efficacy of testosterone~     supplementation as an adjunct to traditional rehabilitation therapy in the care of~     deconditioned older men. Our long range goal is to determine whether other hormones (e.g.,~     combined testosterone and growth hormone) are helpful as an adjunct to traditional~     rehabilitation therapy.~      This project is important to the VA health care system because 38% of American veterans are~     aged (age > 65 years), bioavailable testosterone is diminished in older age men, low~     testosterone is associated with impaired muscle strength, and lack of muscle strength hinders~     rehabilitation. Older men who are not successfully rehabilitated often get admitted to~     nursing homes for long term care, at a cost of approximately $40,000/year. Payment for long~     term care is currently one of our most difficult health care problems. If testosterone~     supplementation improves rehabilitation outcomes, as our pilot data suggest it will, patients~     will be more satisfied and long-term care financial resources will be saved.~      We will conduct a randomized, placebo-controlled trial to test the hypothesis that~     supplementation with testosterone improves rehabilitation outcomes in deconditioned older~     men. Specifically, we will screen all hospitalized older men with delayed discharge from the~     hospital (> 7 day hospital stay). Men who have at least one new impairment in their ability~     to perform activities of daily living (e.g., inability to walk), low serum testosterone~     concentration, and no contraindications (e.g., prostate or breast cancer) will be offered the~     opportunity to participate. Study participants will be randomized to receive either~     testosterone (5 mg transdermally each night) or placebo (matching transdermal patch) daily in~     a double-blind fashion for the duration of their hospital course (expected average duration~     of study is 29 days). Subjects will then receive their rehabilitation as usual, with all~     members of the health care team blinded as to whether the subject is receiving testosterone~     or placebo. At baseline, weekly, at discharge, and at 6 and 12 months after discharge,~     subjects will be assessed using validated measures (i.e., Functional Independence Measure -~     FIM). Our hypothesis is that testosterone supplementation, as an adjunct to traditional~     rehabilitation therapy, will improve rehabilitation outcomes.~   "
271102|NCT00001908|"~     Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow~     obstruction. Fourteen million people (6.4%) in the United States report having asthma, and~     from 1980 to 1994 the prevalence of self-reported asthma in the United States increased 75%.~     Interleukin-4 (IL-4) plays a key role in this response by promoting IgE production,~     upregulating IgE receptors, upregulating adhesion receptors such as VCAM-1, promoting Th2~     cell development and promoting mucus secretion. A soluble form of the receptor for IL-4~     (IL-4R) that has antagonist activity has been developed for clinical use. Soluble IL-4R acts~     by competing with endogenous cell bound IL-4R for free IL-4, thus inhibiting IL-4 function.~     IL-4 is required for the development of allergen specific Th2 memory cells. Less well~     understood are the factors required for maintenance of Th2 responses. The maintenance of~     polarized Th2 responses to allergens have been postulated to require IL-4 itself, by acting~     as an anti-apoptotic/survival factor or by differentiating naive allergen specific T cells to~     the Th2 phenotype. Subjects on sIL-4 therapy represent a unique patient group that possess~     allergen specific Th2 cells, but in which the capacity for IL-4 to promote further Th2 cell~     survival or differentiation has been blocked. This is a single site adjunct study proposed to~     study subjects ages 14 years and older who are enrolled at the NIH Clinical Center on a~     multicenter trial of IL-4R in moderate to severe asthma (Phase II Efficacy Study of~     Aerosolized Recombinant Human IL-4 Receptor in Asthma). A maximum of 40 subjects will be~     enrolled. We hypothesize that effective blocking of such Th2 priming would result in a~     decreased frequency of both allergen specific Th2 cells as well as mitogen activated Th2~     cells. Determination of the fate of Th2 cell responses during long term IL-4R therapy may~     have important implications both for future development of anti-cytokine therapies as well as~     for understanding the T cell biology of allergic diseases and asthma.~   "
271086|NCT00037986|"~     The short-term research objectives of the proposed study are as follows:~        1. To measure the effects of audiological intervention on selected domain specific (i.e.,~          Communicative, Interpersonal, and Social roles) and overall functioning using the~          WHO-DASII, a generic health measure conceptually grounded in the ICIDH-2 model of~          disablement and functioning.~        2. To measure the effects of audiological intervention on selected domain specific (i.e.,~          Role Functioning-Emotional; and, Social Functioning) and overall functioning using the~          MOS-SF36V, a generic health measure currently utilized in the Veteran's Health~          Administration.~        3. To determine the accuracy with which measures of audibility (SII), hearing handicap~          (HHIE), and, hearing disability (APHAB) predict domain specific and overall functioning,~          and life-satisfaction as measured by the WHO-DASII and the MOS-SF36V will be evaluated.~        4. To compare hearing aid treatment effects as measured by changes in WHO-DASII domain~          specific and overall functioning scores to those measured by changes in disease specific~          instruments examining similar constructs.~        5. To compare hearing aid treatment effects as measured by changes in MOS-SF36V domain~          specific and overall functioning scores to those measured by changes in disease specific~          instruments examining similar constructs.~        6. To determine and compare cost-effectiveness of hearing aid intervention as calculated~          using WHO-DASII and MOS SF-36V outcome data.~      The long-term research objective is to compare the cost-effectiveness and cost-utility of~     audiologic intervention with those of other health care interventions commonly associated~     with the veteran population (e.g. mental health, cardiology, pulmonary, orthopedic, etc.).~   "
271087|NCT00037973|"~     The primary objective of the study is to determine whether individuals with Chronic~     Obstructive Pulmonary Disease (COPD) who complete ventilation-feedback training combined with~     a moderately-high intensity exercise and upper body strength program will demonstrate~     significantly longer exercise duration on a constant work rate treadmill test when compared~     to subjects who are randomly assigned to a moderately-high intensity exercise and upper body~     strength training program without ventilation-feedback or ventilation-feedback only.~     Secondary study objectives are to determine whether individuals with COPD who complete~     ventilation-feedback training combined with a moderately-high intensity exercise and upper~     body strength training program will demonstrate significantly: (a) greater exercise tolerance~     and aerobic power; (b) lower perception of breathlessness during progressive and constant~     work rate leg-cycle and treadmill exercise testing; (c) higher tidal volume and lower~     breathing frequency during constant work rate and at any given workload during progressive~     testing; (d) lower score on the Chronic Respiratory Disease Questionnaire indicating improved~     quality of life; (e) higher transition focal score (less dyspnea) on the Transition Dyspnea~     Index; (f) maintain a sustained breathing-pattern adjustment to exercise when compared to~     subjects who are randomly assigned to a moderately-high intensity exercise and upper body~     strength program without ventilation-feedback or ventilation-feedback only.~   "
271088|NCT00037960|"~     We propose to develop and evaluate a workstation that significantly enhances the application~     of Constraint-Induced (CI) Therapy by automating and instrumenting several of the tasks~     currently used in the shaping training. The motivation for development of such a device is as~     follows: 1) Patients could receive CI therapy at home without the need for constant~     supervision from a therapist. Many veterans do not have the resources to travel to their~     local VAMC for the two or three week period required for the treatment. A home-based device~     would expand the pool of veterans who could receive CI therapy. 2) For subjects who were able~     to receive CI therapy in the clinic, this device would facilitate an effective post-treatment~     home-practice program. 3) Currently, patients are treated on a one-on-one basis in the~     clinic. This device could allow one therapist to treat 3 or 4 patients at one time, thereby~     substantially reducing the cost of the therapy. 4) This workstation would provide clear and~     comprehensive quantification of the progress of the treatment. This could indicate on which~     tasks the patient was progressing most and least rapidly, and would therefore enable~     effective modifications of the treatment plan while treatment was in progress.~      The hypothesis is that the positive outcomes of CI therapy can be achieved, and possibly~     enhanced, if the shaping training component is performed in a workstation that guides,~     motivates and records exercise of the more-affected limb. In the first 18 months, the~     workstation will be designed and fabricated. To expedite the design, we will rely on simple~     modifications to off the shelf components. In the last 18 months, a controlled, randomized,~     clinical trial will compare the effectiveness of automated CI therapy programs with standard~     CI therapy. The standard CI therapy group would receive shaping training in a clinical~     setting, one-on-one with a therapist. The clinic-based automated CI therapy group would~     perform the shaping training in the workstation, in a clinical setting and with minimal~     supervision. The home-based automated CI therapy group would perform the shaping training at~     home in the workstation, and with no direct supervision. All other aspects of the three~     treatment programs will be identical. At the end of this 3-year project, a device will have~     been designed, built and evaluated that could significantly enhance the application of CI~     therapy for chronic stroke patients.~   "
271089|NCT00037947|"~     We propose to evaluate auditory function and neuropsychologic function in 150 Multiple~     Sclerosis (MS) patients and in 150 patients who do not have MS. Experimental subjects will be~     recruited by selecting patients with a verified diagnosis of MS from the registry of patients~     established by the Oregon Health Sciences University, Multiple Sclerosis Research Center.~     Control subjects will be matched with respect to age, to gender and to audiometric~     configuration.~   "
271090|NCT00037934|"~     We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke~     patients using a robot for neurological rehabilitation designed and built by MIT. Results of~     a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated~     by patients and produces a significant, measurable benefit. We propose to test that the~     robotic upper extremity trainer is an acceptable cost effective adjunct to standard~     occupational therapy for patients with dysfunction of the shoulder and elbow due to~     hemiparetic stroke in a VA rehabilitation program.~   "
271111|NCT00037752|"~     The purpose of this study is to determine if sibutramine will decrease post-cessation weight~     gain and cigarette smoking in overweight and obese smokers who quit smoking.~   "
271112|NCT00037739|"~     To localize within the genome a chronic obstructive pulmonary disease susceptibility gene.~   "
271113|NCT00037726|"~     To examine possible relationships between antibiotic use, as determined by prescriptions~     filled, and asthma in children ages 6 to 7.~   "
271114|NCT00037713|"~     This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on~     survival in patients with LD Small Cell Lung Cancer (SCLC). Patients will be stratified by~     institution, KPS (60 - 70% vs 80 - 100%), and response to first line combined modality~     therapy (CR vs PR) that consisted of at least a 2 drug regimen (4 - 6 cycles) and a chest~     radiotherapy regimen. Patients will be randomized to one of two treatment arms: standard arm~     (Observational cohort) or best supportive care, or the treatment arm (5 intradermal~     vaccinations of BEC2 (2.5 mg) + BCG given on day 1 of weeks 0, 2, 4, 6, and 10.~   "
271138|NCT00037401|"~     To compare the effects of statin therapy alone with statin plus fibrate therapy on several~     emerging risk factors for atherosclerotic cardiovascular disease in a representative subgroup~     of the ACCORD cohort that is being followed for cardiovascular endpoints.~   "
271091|NCT00037921|"~     Urinary tract infection (UTI) is the most common infection in patients with SCI and is a~     major cause of morbidity and mortality in this population. The bladder of patients with SCI,~     especially those who have indwelling catheters, is often colonized by bacteria that may or~     may not cause symptoms of UTI. Bacteria that do not cause symptoms are usually considered~     benign colonizers and are often left untreated because they may afford some protection~     against symptomatic infection with more harmful bacteria.~      We applied the concept of using benign bacteria to prevent symptomatic infection, so-called~     bacterial interference, by deliberately colonizing the bladder of patients with SCI with a~     non-pathogenic prototype of Escherichia coli (strain 83972). The preliminary results of our~     VA-funded study that compared the rates of symptomatic UTI in patients with SCI while~     colonized with E. coli 83972 vs. historical rates of symptomatic UTI prior to study~     enrollment indicated that deliberate colonization of the bladder of patients with SCI with E.~     coli 83972 is safe and very promising as to its ability to prevent symptomatic UTI. However,~     before this innovative approach of bacterial interference can be successfully applied in the~     population of patients with SCI, it is essential to: (A) confirm the ultimate efficacy of~     bacterial interference by conducting a prospective, randomized, placebo-controlled clinical~     trial (objective #1); and (B) enhance the practicality of applying this innovative approach~     in SCI patients by delineating the bacterial and host factors that can promote successful~     colonization with E. coli 83972 (objectives #2-3).~   "
271092|NCT00037908|"~     Our overall goal is to develop therapeutic interventions to improve upper-limb motor function~     in hemiparetic persons based on an improved understanding of the mechanisms responsible for~     its loss and recovery. We intend to rigorously evaluate the efficacy of these interventions~     with clinical trials, and to study the mechanisms by which these interventions affect motor~     recovery. In this proposal, we will use a controlled, randomized, double blind clinical trial~     to study the effects of shoulder and elbow strength training in subjects in the subacute~     phase of recovery following stroke.~   "
271093|NCT00037895|"~     This project seeks to overcome the reduced walking capability, poor health status, decreased~     functional capacity, and sedentary lifestyle of stroke patients. The specific objectives are~     to compare the effects of regular inpatient stroke rehabilitation to regular rehabilitation~     combined with STAT after an acute stroke on: a) gait performance; b) functional outcomes; c)~     oxygen consumption during a seated task; and finally: d) using Brain Motor Control Assessment~     to obtain neurophysiological characteristics, as possible predictors of rehabilitation~     outcomes.~   "
271094|NCT00037882|"~     The purpose of this study is to determine if PEG-Intron is better tolerated and more~     efficacious than standard interferons (Roferon, Intron) in patients with~     Philadelphia-positive Chronic Myelogenous Leukemia. These patients should have previously~     received standard interferon therapy and have been intolerant, resistant, or have relapsed~     disease.~   "
271095|NCT00037869|"~     The goal of this clinical research study is to learn if I-131 Metaiodobenzylguanidine (MIBG)~     can shrink or slow the growth of the tumor(s) in patients with metastatic neuroendocrine~     tumors. The safety of this treatment will also be studied.~   "
271096|NCT00037843|"~     This is a clinical research study using I-131 Iodocholesterol which is an experimental~     radioactive chemical that when injected into the vein, is picked up in the adrenal glands and~     permits visualization with gamma imaging devices. These images are used in diagnosing a~     variety of adrenal abnormalities.Prior to the injection of I-131 Iodocholesterol, the patient~     will receive perchlorate capsules to block any uptake of I-131 by the thyroid gland if this~     is deemed important. The patient will continue to take these capsules throughout the period~     of imaging, which may last up to 1 week. The injection of I-131 Iodocholesterol will be given~     into a vein and the patient will return for images on at least 1 and possibly 2 occasions~     between 3-7 days after injection. If the case requires it, the patient may also be given a~     steroid in tablet form, dexamethasone, to take orally prior to and after the injection to~     suppress normal adrenal function so that the abnormal tissues can be more easily detected.~   "
271097|NCT00037830|"~     The purpose of this trial is to examine the short term effects (24 Weeks) of GM1 on~     Parkinson's disease (PD) symptoms, as well as the effects of long-term treatment (120 Weeks)~     with GM1 on disease progression, and to examine the extent to which GM1 treatment influences~     the underlying disease process in PD.~   "
271098|NCT00037817|"~     Background:~      Previously we have demonstrated induction of tumor antigen and tumor suppressor gene~     expression in lung cancer cells following exposure to the DNA demethylating agent, Decitabine~     (DAC). We have also demonstrated that DAC mediated target gene expression and apoptosis can~     be significantly enhanced in cancer cells by subsequent exposure to the histone deacetylase~     (HDAC) inhibitor Depsipeptide FK228 (DP). Furthermore, we have demonstrated that following~     DAC, or DAC/DP exposure, cancer cells can be recognized by cytolytic T cells specific for the~     cancer testis antigen, NY-FSO-1.~      This Phase I study will evaluate gene induction in thoracic oncology patients mediated by~     sequential DAC/DP treatment with or without the selective COX-2 inhibitor, celecoxib.~      Objectives:~      Evaluation of the pharmacokinetics and toxicity of continuous 72-hour intravenous Decitabine~     (DAC) infusion followed by 4-hour intravenous infusion of Depsipeptide FK228 (DP) with or~     without oral celecoxib in patients with unresectable cancers involving the lungs or pleura.~      Analysis of NY-ESO-1, p16 and p21 expression in cancer specimens before and after sequential~     Decitabine/Depsipeptide treatment.~      Analysis of serologic response to NY-ESO-1 before and after sequential drug treatment.~      Analysis of apoptosis in tumor biopsies before and after sequential Decitabine/Depsipeptide~     treatment.~      Refinement of laser capture microdissection and micro-array techniques for analysis of gene~     expression profiles in tumor tissues.~      Eligibility:~      Patients with histologically or cytologically proven primary small cell or non-small cell~     lung cancers, advanced esophageal cancers, pleural mesotheliomas, or non-thoracic cancers~     with metastases to the lungs or pleura.~      Patients must be 18 years or older with an ECOG performance status of 0-2 and have adequate~     pulmonary reserve evidenced by FEV1 and DLCO greater than the 30% predicted, and less than 50~     mm Hg and p02 greater than 60 mm Hg on room air ABG.~      Patients must have a platelet count greater than 100.000. an ANC equal to or greater than~     1500 without transfusion or cytokine support, a normal PT, and adequate hepatic function as~     evidenced by a total bilirubin of less than 1.5 x upper limits of normal. Serum creatinine~     less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70~     ml/min/1.73m(2).~      Design:~      Patients with inoperable malignancies involving lungs or pleura will receive two cycles of~     72-hour intravenous infusion of Decitabine followed by 4-hour Depsipeptide infusion using a~     Phase I study design.~      Decitabine will be administered by continuous infusion on days 1-4, and patient cohorts will~     receive escalating doses of Depsipeptide administered on day 4 and day 10 of a 34 day cycle.~      Once the MTD and toxicities for sequential DAC/DP have been identified, additional cohorts of~     6 lung cancer patients and 6 mesothelioma patients will receive sequential DAC/DP~     administered at the MTD as outlined above with celecoxib (400mg bid) administered on days~     4-34 of each treatment cycle, as a means to enhance target cell apoptosis and facilitate~     anti-tumor immune recognition/response.~      Pharmacokinetics, systemic toxicity, and response to therapy will be recorded. Tumor biopsies~     will be obtained prior to, and after therapy to evaluate expression of NY-ESO-1 tumor~     antigen, as well as p16 and p21 tumor suppressor genes, which are known to be modulated by~     chromatin structure. Additional analysis will be undertaken to evaluate the extent of~     apoptosis in tumor tissues, and to determine if immune recognition of NY-ESO-1 can be~     demonstrated following sequential DAC?DP +/- celecoxib treatment.~      As the exact set of comparisons and analyses to be performed will be determined following~     completion of the trial and will be based on limited numbers of patients, the analyses will~     be considered exploratory and hypothesis generating rather than definitive.~      A total of 40 patients will be enrolled.~   "
271099|NCT00037804|"~     Drugs used in chemotherapy us different ways to stop tumor cells from dividing so they stop~     growing or die. Irinotecan may be effective in treating patients with refractory solid tumors~     and liver dysfunction.~   "
271100|NCT00037791|"~     Intensive chemotherapy is associated with significant thrombocytopenia, often requiring~     platelet transfusion to maintain platelet counts. This investigational drug has demonstrated~     the ability to increase platelet counts. This study will test the safety and efficacy of this~     investigational drug in the prevention of thrombocytopenia in patients with solid tumors,~     lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring~     platelet transfusion support.~   "
271101|NCT00004575|"~     This study will investigate the effect of the drug miconazole on blood vessel dilation.~     Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is~     produced by the cells that line blood vessels.~      Normal volunteers between the ages of 21 to 60 may participate in this study. Candidates will~     be screened for eligibility with a medical history, physical examination, electrocardiogram~     and routine laboratory tests. Those enrolled will be injected with miconazole to study its~     effects on blood vessels.~      Study participants will take three aspirin tablets. After administration of a local~     anesthetic, small tubes will be inserted through a needle into the artery and vein of the~     forearm. These will be used to measure blood pressure and to draw blood samples during the~     study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper~     arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are~     inflated, blood will flow into the arm, stretching the strain gauge, and the flow measurement~     will be recorded.~      Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be~     given through the arterial catheter. Bradykinin stimulates the release of EDHF and can lower~     blood pressure. Sodium nitroprusside causes blood vessels to dilate and is used to treat high~     blood pressure and heart failure. Miconazole is commonly prescribed to treat various~     infections, including vaginal yeast infections, jock itch and athlete's foot. In much higher~     doses, it is used to treat fungal infections that have spread to the lungs, brain, kidneys,~     or bladder. LNMMA inhibits production of nitric oxide, another substance produced by the~     lining cells of blood vessels.~      Blood flow will be measured throughout the study, which will last approximately 3 hours.~   "
271135|NCT00037440|"~     To extend knowledge of the genetic factors affecting the course of cardiovascular disease~     risk factor development over a substantial portion of an individual's lifetime.~   "
271136|NCT00037427|"~     To determine lung airway responses following chlorine gas exposure.~   "
271103|NCT00001866|"~     This study will examine the safety and effectiveness of a new surgical procedure to correct~     congenital nystagmus-a disorder of eye muscle-vision-brain coordination characterized by~     rapid to and fro eye movements (oscillation). Nystagmus usually begins in infancy or early~     childhood; its effect on vision varies greatly among patients. Current treatments, such as~     prism glasses, acupuncture, electronic nerve stimulation, contact lenses, various drug~     treatments, and others have had limited success.~      Patients with congenital nystagmus sometimes have other eye problems as well, such as~     cataracts, glaucoma, astigmatism or strabismus (cross-eyes). When these patients have eye~     muscle surgery to correct a problem, such as strabismus, their nystagmus also improves.~     Researchers think that simply cutting the muscles might produce this beneficial effect. This~     study will test this hypothesis-the horizontal muscles of the eye will be cut and then~     reattached in the same position. This procedure has been tried in one sheepdog with good~     results.~      This small preliminary trial will include five adult patients with congenital nystagmus who~     have no other treatment options. It will evaluate the safety of the surgery and its effect on~     eye oscillation and vision. If the procedure is found to be safe, additional patients will be~     studied.~      Patients will have a medical history, basic physical examination, complete eye examination,~     and electro-oculography (eye movement recordings) to determine if eligibility for the study.~     Those accepted into the study will undergo eye muscle surgery and followup eye examinations~     and electro-oculography at 1 week, 6 weeks, 6 months, 1 year, 2 years and 3 years after~     surgery.~   "
271104|NCT00001864|"~     The purpose of this study is to compare the results of two standard treatments for amblyopia~     in order to find out if one is more effective than the other. Amblyopia, which develops in~     childhood, is also called lazy eye, because one eye is not being used properly. The brain~     favors the other eye for some reason, such as crossing or turning out of the eyes, and vision~     in the weak eye is reduced.~      Amblyopia is treated by forcing the child to use the weak eye. There are two ways to do this:~     1) a patch placed over the good eye forces the child to use the weak eye; or 2) an eye drop~     placed in the good eye once a day to blur vision in that eye makes the child rely on the~     weak eye. The success rates with both of these methods have been reported to be about the~     same; this study will try to identify if one is more effective than the other.~      Children will be randomly assigned by computer to one of the following two treatment methods:~      Patch~      The child initially will wear a patch over the good eye for 8 to 12 hours every day. If~     vision in the weak eye improves, the patching time will be decreased. If vision remains good~     after 3 months, the patching will be stopped, unless the child's doctor believes treatment~     should continue. If vision in the weak eye does not improve, the patching time will be~     increased.~      Eye Drops~      The child will be given one drop per day of atropine in the good eye. If vision in the weak~     eye improves, the drops will be given less often. If the vision remains good after 3 months,~     the drops will be stopped, unless the child's doctor believes treatment should continue. If~     the initial daily drop does not improve the vision in the weak eye, the child's eyeglasses~     may be changed to try to further blur the vision in the good eye.~      After 6 months, treatment may be stopped if it has not been successful. If treatment has been~     successful after 6 months, it may be continued at a reduced amount or stopped.~      Follow-up visits will be scheduled every 4 weeks for the first 6 months and every 2 to 4~     months after that until the end of the 2-year study. During each visit the eyes will be~     examined for eye movements and vision, and the pupils will be dilated to examine the inside~     of the eye.~   "
271105|NCT00001818|"~     This study will test the safety and effectiveness of hydroxyurea, an anti-cancer drug, given~     together with the anti-HIV drugs didanosine, stavudine and efavirenz for treating children~     infected with human immunodeficiency virus (HIV). Some studies have found that hydroxyurea~     may help certain anti-HIV drugs to work better and that the virus does not become resistant~     to it, as it does other drugs. This study will also examine how hydroxyurea affects the~     body's immune system and virus levels.~      Patients 3 through 21 years old with HIV infection may be eligible for this 52-week study.~     They will be screened for eligibility with a thorough physical examination, including chest~     X-ray, electrocardiogram and echocardiogram, head CT scan, eye examination and blood tests.~      All patients in the study will take didanosine twice a day, stavudine twice a day and~     efavirenz once a day. All patients will also take hydroxyurea twice a day, but some will take~     a low dose of the drug, while others will take a high dose. Within each of these two groups~     (high and low dose) some patients will start taking hydroxyurea the same day they begin the~     anti-HIV drugs; others will not start hydroxyurea until after they have taken the anti-HIV~     drugs for 5 weeks. Patients will have a physical examination every 3 weeks until week 12,~     then every 4 weeks until week 24, and then every 8 weeks until the end of the study. Blood~     tests to measure virus levels will be done every other day for the first 7 days and~     periodically after that. For the first 8 weeks after starting hydroxyurea, blood tests will~     be done weekly. An eye examination, chest X-ray, electrocardiogram, and CT scans of the head~     will be done about every 6 months.~   "
271106|NCT00001688|"~     This is a pilot study to evaluate the ability of highly active antiretroviral therapy~     administered to children with HIV-1 infection to effect immunoreconstitution in children with~     HIV-1 infection. In addition, this study will determine the safety of combination therapy~     with ritonavir, nevirapine and stavudine (d4T) as well as the anti-HIV activity of~     combination therapy with ritonavir, nevirapine and stavudine. A total of 25 HIV-1 infected~     children will be studied, including both moderately and severely immunocompromised~     individuals. The children will be treated with ritonavir, nevirapine and stavudine or with~     predefined drug substitutions in the case of intolerance. Immunoreconstitution, defined as~     the repopulation of naive T cells, will be studied by determining the presence and extent of~     production of new naive (thymic derived) CD4+ T cells and their T cell receptor repertoire.~     Drug pharmacokinetic profiles in this regimen will be examined.~   "
271107|NCT00001542|"~     This is a placebo-controlled trial of intermittent fluconazole prophylaxis (200 mg orally~     three times a week) in the prevention of thrush.~   "
271108|NCT00001190|"~     Children with extreme short stature (height) and their families often experience significant~     psychological stress related to concerns about adult height. In addition, short stature often~     results in life-long emotional, social, and physical obstacles to the affected person.~      Normal growth occurs in two phases. The first phase, known as childhood growth, occurs below~     the age of 10. The second phase of growth, teen-age or adolescent growth, begins between the~     ages of 10 and 15. In addition, puberty marks the time when the bone's growth plates~     (epiphysis) begin to close, initiating the completion of linear growth (height).~      Some children suffer from a condition called precocious puberty, meaning that puberty begins~     at a younger age than normal. The development of medications known as synthetic LHRH analogs~     have provided a method to delay puberty and treat these patients.~      LHRHa (deslorelin) is a hormone created to act like naturally occurring LHRH. It been used in~     patient's diagnosed with precocious (early onset) puberty. The drugs were able to regress~     patient's clinical signs of puberty, decrease the levels of adult sex hormones produced, and~     slow the rate of bone aging.~   "
271109|NCT00037778|"~     The purpose of this study is to identify modifier genes in cystic fibrosis (CF).~   "
271110|NCT00037765|"~     The purpose of this study is to examine genetic modifiers of the severity of cystic fibrosis~     lung disease.~   "
271115|NCT00037700|"~     The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept~     (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid~     arthritis. The study will also evaluate the safety of the combination treatment and its~     effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results~     will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is~     used.~   "
271116|NCT00037687|"~     The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all~     cause mortality in patients with severe sepsis.~   "
271117|NCT00037674|"~     This primary purpose of this study is to evaluate the safety and efficacy of topiramate~     compared with lithium or placebo in the treatment of acute manic or mixed episodes in~     patients with Bipolar I Disorder.~   "
271118|NCT00037661|"~     Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry~     eye.~   "
271119|NCT00037648|"~     The purpose of this study is to determine the safety of anakinra in patients with~     Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting~     children.~   "
271120|NCT00037635|"~     This 6 month long study will assess an investigational medication for patients on dialysis~     with secondary hyperparathyroidism. The study will look at the effects on parathyroid~     hormone, calcium and phosphorus levels.~   "
271121|NCT00037622|"~     The purpose of this study is to determine the safety and antiviral HBV activity of~     ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase~     1 and 2 Studies in Chronic Hepatitis B Infection.~   "
271122|NCT00037609|"~     The primary objective of the phase I study is to determine a safe dose for combination~     therapy with capecitabine and exisulind. A secondary objective is to assess pharmacokinetic~     interactions between the two drugs and assess the biological activity of exisulind.~      The primary objective of the Phase II part of this study is to assess the anti-tumor activity~     of this combination therapy measured by objective tumor response. Secondary end points also~     assessed will be toxicity of therapy, duration of response and time to progression.~   "
271123|NCT00037596|"~     The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab~     ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab~     ozogamicin when given concurrently with cytarabine.~   "
271124|NCT00037583|"~     The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab~     ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of~     gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.~   "
271125|NCT00037570|"~     This is a multicenter, randomized, double-blind, parallel-group, dose-ranging,~     comparator-controlled study of the effect of pantoprazole on intragastric pH after successful~     endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous~     pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of~     successful hemostasis and administration will continue for 72 hours after hemostasis.~   "
271126|NCT00037557|"~     To characterize the safety and efficacy of rFIX in children less than 6 years of age with~     severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery.~      This study will provide an opportunity for systematic observation of treatment with rFIX in~     children less than 6 years of age regardless of prior FIX treatment. Younger patients exhibit~     a different pharmacokinetic profile and therefore may respond differently to rFIX infusions~     when compared with older children and adults. This evaluation will provide data from which~     recommendations can be made regarding rFIX dosing and treatment of these patients.~     Surveillance for certain observations that have been made in patients treated with rFIX in~     the clinical and postmarketing setting will be performed, including inhibitor development,~     thrombogenicity, FIX recovery/lack of effect, allergic-type manifestations, and RBC~     agglutination. Comparisons will be derived from published reports and communications~     describing experience with other FIX products and protein therapeutics in general.~   "
271127|NCT00037544|"~     To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes~     during prophylaxis treatment, including neoantigenicity.~   "
271128|NCT00037531|"~     To evaluate the safety of long-term administration of sirolimus oral solution for up to 5~     additional years, or until the tablet formulation is commercially available (whichever occurs~     first) in solid organ transplant recipients who are currently receiving sirolimus and who~     have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To~     evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets~     administered for up to 5 years, or until the tablet formulation is commercially available in~     solid organ transplant recipients who are currently receiving sirolimus and who have~     completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled~     in protocol 0468E1-306-US.~   "
271129|NCT00037518|"~     This study will assess an investigational medication for patients with severe primary~     hyperparathyroidism or parathyroid cancer.~   "
271130|NCT00037505|"~     The overall purpose of this research is to examine whether depression influences immune~     system function. Studies indicate that individuals who are depressed experience coronary~     heart disease at a higher rate than expected. This study's goal is to begin identifying~     mechanisms that might be responsible for this process. This research also examines whether~     behavioral processes (e.g. smoking) or hormonal processes (e.g. adrenaline release) are~     responsible for immune system differences between depressed and nondepressed people~   "
271131|NCT00037492|"~     The purpose of this trial is to assess the effects of a psychosocial intervention on~     functional recovery after stroke.~   "
271132|NCT00037479|"~     The purpose of this study is to determine whether patients with persistent memory problems~     after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use~     modern brain imaging technology to determine whether the problem in the central nervous~     system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to~     try to identify biological markers prior to treatment that will identify patients who are~     more or less likely to respond to the study treatment.~   "
271133|NCT00037466|"~     To examine the relation between diet and plasma total homocysteine levels in an ethnically~     and geographically diverse cohort of adolescents.~   "
271134|NCT00037453|"~     To analyze the relationship of sex hormones to lipoproteins in young males.~   "
271150|NCT00037245|"~     To examine whether serum androgens, measured earlier in life, and variation in genes related~     to androgen synthesis, metabolism, and signaling are associated with early-onset subclinical~     coronary atherosclerosis in young adult women from the community.~   "
271151|NCT00037232|"~     To develop statistical methodologies to study genetic and environmental factors in~     cardiovascular disease, using age at onset data from population-based family studies of~     disease incidence.~   "
271152|NCT00037219|"~     Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose~     of the study is to find the balance between dose tolerance and effectiveness of several doses~     for the treatment of United States patients with invasive candidiasis.~   "
271153|NCT00037206|"~     The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients~     treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety~     and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated~     patients located in the United States, Europe, and South Africa.~   "
271154|NCT00037193|"~     Patients with end stage renal disease often have secondary hyperparathyroidism due to high~     phosphorus and low calcium levels in the blood. Preliminary animal studies and our initial~     human study indicate that the parathyroid hormone levels may change quickly based on the~     ingestion of phosphorus, prior to any change in the blood levels of calcium or phosphorus.~     This follow-up study will attempt to determine if the effect is independent of an increase in~     the blood glucose level. If so, this would suggest an as yet unidentified gastrointestinal~     receptor that mediates parathyroid hormone levels. This may affect the timing of~     administration and the type of phosphate binder used in treating patients with secondary~     hyperparathyroidism. The knowledge that parathyroid hormone levels can change acutely may~     also affect the recommended timing of blood samples~   "
271155|NCT00037180|"~     The Diarrhea Prevention with an investigational drug trial, will evaluate whether adding an~     investigational drug to the standard treatment for advanced colorectal cancer can reduce the~     amount of diarrhea a patient experiences. The standard and approved treatment for patients~     with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a~     combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as~     5FU), and leucovorin (also known as LV). Preclinical data from animal models suggest that the~     investigational drug may offer an effective means for preventing CPT-11/5FU/LV-induced~     diarrhea. It is also hypothesized that the investigational drug-mediated anti-angiogenesis~     could induce a favorable tumor response.~   "
271156|NCT00037167|"~     This study uses a patented type of exercise poles, developed to assist runners rehabilitating~     from lower body injuries. These poles may offer older adults improved stability, reduced fear~     of falling, and lessened lower body pain when exercise walking.~   "
271157|NCT00037154|"~     The purpose of this study is to test whether an extract of the saw palmetto plant is~     effective for relieving symptoms of Benign Prostatic Hyperplasia (BPH).~   "
271158|NCT00037141|"~     Multi-center, prospective randomized dosing and safety research study. A maximum of 150 men~     will be enrolled in the study. Qualifying patients will receive one of three possible doses~     of the study drug. Symptoms will be evaluated before treatment, and then 1-week, 1-month,~     3-months, and 6-months following treatment.~   "
271159|NCT00037128|"~     Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be~     caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug~     meant to enhance DHEA levels. This study is designed to evaluate both the safety and efficacy~     of GL701 in male lupus patients.~   "
271160|NCT00037115|"~     The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta~     1-a) and a one-time high dose intravenous methotrexate with Leucovorin rescue, along with the~     standard solumedrol treatment before beginning AVONEX® treatment.~   "
271161|NCT00037102|"~     The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta~     1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue.~   "
271162|NCT00037089|"~     This study is for patients with esophageal cancer that has spread to other areas. The purpose~     of this study is to:~        1. Determine how well a combination of taxol, UFT, and leucovorin work in these patients,~        2. Determine the survival of patients with metastatic esophageal carcinoma treated with~          this combination of drugs.~        3. Identify the side effects of this drug combination.~   "
271163|NCT00037076|"~     The purpose of this study is to find out how many children who are infected with HIV are also~     infected with hepatitis C virus (HCV).~      HCV infection is a major health concern. HIV-infected adults who are co-infected with HCV~     appear to have more rapid HIV disease progression. There is little data on how widespread HCV~     is among children who are HIV-infected. Information from this study will help determine the~     need for future HCV studies. This study also will obtain blood samples for future testing for~     other hepatitis viruses such as hepatitis G virus (HGV or GB virus C).~   "
271164|NCT00037063|"~     The purpose of this study is to see if certain vitamins (C, E, B1, and B2) can keep lactate~     levels from becoming too high in patients who are taking nucleoside reverse transcriptase~     inhibitor (NRTI) anti-HIV drugs.~      Some patients taking anti-HIV drugs develop hyperlactatemia. Hyperlactatemia is a condition~     in which lactate (a natural substance normally present in the body) levels are too high. Too~     much lactate in the body can lead to serious health problems. When patients suffer from~     hyperlactatemia while taking anti-HIV drugs, most doctors temporarily stop the drugs.~     Patients then restart the anti-HIV drugs when their lactate levels return to normal. If~     patients restart the same drugs they were taking when they developed hyperlactatemia, there~     is a risk that they may develop high lactate levels again. This study wants to find out if~     taking antioxidants (substances that reduce tissue damage due to oxygen radicals) and certain~     B vitamins may help prevent patients from developing hyperlactatemia when they restart the~     same anti-HIV drugs.~   "
271165|NCT00037050|"~     This study will treat patients who have a short term central catheter that is thought to be~     infected with a specific bacteria (gram positive bacteria)~   "
271166|NCT00036647|"~     The purpose of this study is to determine if OSI-774 will improve overall survival of~     patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of~     care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor~     receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the~     U.S. Food and Drug Administration (FDA).~   "
271170|NCT00036595|"~     This study examines the relationship between a cerebral hemisphere and control of muscles on~     the same side of the body (ipsilateral control). One good way to study this relationship is~     to record electroencephalogram (EEG) activity directly from the cortical surface. Because~     patients with epilepsy who are surgical candidates are already undergoing monitoring with~     subdural and/or depth electrodes, they present an opportunity to study ipsilateral control.~     Studying the electrocorticographic (ECoG) activity associated with simple voluntary movement~     in such patients would not disturb ongoing monitoring of nearby areas of the brain, nor would~     it endanger the patients.~      Ten patients, who may be children or adults, will be recruited for this study. Brain activity~     will be measured while they move the corner of their mouth and their fingers, wrists, arms,~     and feet. The baseline measurements will be done with scalp electrodes. Once subdural~     electrodes have been placed, a second set of measurements will be done. Surface EMG~     electrodes will be placed on the muscles whose movements are being tested. The tests will be~     done on no more than 3 separate days, in sessions no longer than 2 hours, for each patient.~   "
271171|NCT00036582|"~     The purpose of this study is to determine the safety and effectiveness of clozapine in~     children and adolescents with treatment resistant bipolar disorder. This study will also~     explore how the brain functions in early-onset bipolar disorder.~   "
271172|NCT00036569|"~     Diffuse pontine gliomas are tumors on the pons portion of the brainstem. Their peak incidence~     is in children between 5 and 10 years old. Their location makes surgical resection~     impossible. Most patients are treated with radiation, which typically delays progression of~     the tumor for a median time of only about 6 months; median survival time is less than 1 year.~     The addition of chemotherapy has not improved the outcome.~      Alpha, beta, and gamma interferons have been used to treat malignant brain tumors, with mixed~     results. Different doses and different methods of administration have been studied. Alpha~     interferon is usually given in high doses 2 or 3 times a week, but it has serious side~     effects at these doses. Recent studies have shown that administering chemotherapy more~     frequently at smaller doses (metronomic) may have a better effect against the tumor.~      PEG-Intron(Trademark) is a form of interferon alpha combined with monomethoxy polyethylene~     glycol (PEG). It has a longer half-life than interferon alone, is administered once a week,~     and the long half-life reduces the peaks and troughs in blood levels.~      This study will enroll 32 patients under age 21. The primary goals of the study are to~     determine if there is a difference in the 2-year survival rate of patients treated with~     radiation alone and those treated with radiation followed by PEG-Intron(Trademark) and to~     define the toxicities of PEG-Intron(Trademark) in the study doses. Secondary goals are to~     evaluate various magnetic resonance imaging (MRI) techniques for noninvasive monitoring of~     changes in the brainstem and to evaluate neuropsychological function.~      In this study, PEG-Intron(Trademark) will be administered subcutaneously once a week at low~     doses (0.3 microgram per kilogram of body weight) for a 4-week cycle. The cycles will be~     repeated indefinitely until progression of disease or serious side effects develop. For less~     severe effects, the dose will be lowered and the patient may remain in the study. For more~     severe effects, the dose will be discontinued. Patients in the study may receive supportive~     medication but may not receive other forms of chemotherapy.~      Patients or their caregivers will be instructed in how to inject the drug. Patients and/or~     caregivers will be asked to maintain a diary documenting the dose, site of administration,~     and any side effects. The diary will be reviewed at each National Cancer Institute (NCI)~     visit. Patients will return to NCI before cycles 2 and 3. If there are no significant side~     effects, patients may then return to NCI before every other cycle, indefinitely (i.e., before~     cycles 5, 7, 9, etc.).~      Patients will undergo the following tests and procedures:~        -  Physical examination, including neurologic exam, monthly~        -  Complete blood count, differential, and platelet count weekly during cycle 1 and every 2~          weeks thereafter if no severe side effects occur~        -  Blood chemistries weekly during cycle 1 and every 2 weeks thereafter if no severe side~          effects occur~        -  Endocrine function tests before each cycle~        -  Urinalysis before each cycle~        -  MRI of the brain before cycles 1, 2, 3, 5, 7, and every other month; patients may also~          have proton magnetic spectroscopic imaging performed at the time of the MRI~   "
271173|NCT00036556|"~     This study is being done to evaluate the safety and efficacy of atrasentan in men with~     non-metastatic hormone-refractory prostate cancer.~   "
271174|NCT00036543|"~     This study is being done to evaluate the safety and efficacy of atrasentan in men with~     metastatic hormone-refractory prostate cancer.~   "
271175|NCT00036517|"~     The triple combination chemotherapy of irinotecan, 5-fluorouracil and leucovorin~     (CPT-11/5-FU/LV or Saltz regimen) is the treatment of choice for patients with advanced~     colorectal cancer. Severe diarrhea, unfortunately, is a side effect of such treatment.~     Preclinical studies have indicated that the botanical drug PHY906 can reduce such diarrhea~     without compromising the effectiveness of the chemotherapy. The primary purpose of this~     clinical study is to evaluate the safety, tolerability and minimum effective dose of PHY906~     when administered in conjunction with the Saltz regimen.~   "
271176|NCT00036504|"~     The purposes of this study are to determine: 1. If patients taking insulin lispro LM with~     metformin will have better overall control of their blood sugar than patients taking a long~     acting insulin comparator with metformin. 2. If there is a difference in the way the two~     treatments affect blood sugar control before and after meals and at night. 3. If there is a~     difference in the insulin dose required with the two treatments. 4. If there is a difference~     in the numbers of times patients experience low blood sugar with the two treatments. 5. If~     there is a difference in the effect on patients's body weight.~   "
271177|NCT00036491|"~     The purpose of this study is to determine the safety and effectiveness of rituximab~     (anti-CD20) in treating systemic lupus erythematosus (SLE).~      White blood cells in the body called B cells give off substances that are active in promoting~     SLE disease. Researchers have found that anti-CD20 can block production of these substances~     in another disease. This study explores whether anti-CD20 will also be safe in people with~     SLE and whether it may be effective in treating SLE.~   "
271178|NCT00036478|"~     The purpose of this study is to see if magnetic resonance spectroscopy (MRS) can be used to~     detect damage to the mitochondria in HIV-infected patients taking nucleoside reverse~     transcriptase inhibitor (NRTI) drugs.~      HIV-infected patients taking NRTI drugs may have an increase in a chemical in their blood~     called lactate. High lactate levels may damage the energy source of the cell (mitochondria).~     Damage to mitochondria may cause lactic acidosis, liver failure, and other problems. It is~     important to find effective ways to see if the mitochondria of HIV-infected patients have~     been damaged. This study will see if MRS can be used to determine mitochondrial damage.~   "
271179|NCT00036465|"~     This study will look at people who have been taking anti-HIV drugs but still have detectable~     levels of HIV. The purpose of the study is to find out what happens in those people who~     change anti-HIV drugs when their viral load reaches 200 copies compared to those who change~     anti-HIV drugs when their viral load reaches 10,000 copies. This study will also look at drug~     resistance (how well HIV responds to drugs), viral fitness (how well drug-resistant HIV~     copies itself), and immunologic reconstitution (how well the immune system recognizes various~     infections, including HIV).~      Many patients experience virologic relapse (increase in viral load after sustained viral load~     suppression) within 1 to 2 years of taking anti-HIV drugs. The approach to treatment for~     patients who experience virologic relapse while on a highly active antiretroviral therapy~     (HAART) has not been defined. Current guidelines recommend switching to a new treatment~     regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV~     drugs. However, there is evidence that patients can benefit from staying on the same HAART~     drugs, even after virologic relapse. This study wants to find what happens when drugs are~     changed immediately after virologic relapse (when the viral load is lower) compared to what~     happens if drugs are changed only after a delay (when the viral load is higher).~   "
271180|NCT00036452|"~     Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor.~     Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking~     them all correctly. The easier it is to take anti-HIV drugs, the more likely people will take~     them as prescribed and get the best results. This study will see if people are more~     successful in taking anti-HIV drugs once a day or twice a day. It also will determine if~     having a health care professional oversee each weekday dose helps people control their HIV~     infection. The study will compare taking a three-drug combination twice a day versus taking a~     three-drug combination just once a day. The study will also compare patients taking the drugs~     on their own to patients taking the drugs in the presence of a clinical worker. Viral load~     (amount of HIV in the blood) and drug side effects will be measured.~   "
271181|NCT00036439|"~     The purpose of this study is to evaluate the effectiveness and safety of infliximab~     (Remicade) in patients with Ulcerative Colitis.~   "
271182|NCT00036426|"~     The purpose of this study was to determine if an idiotype vaccine, made from a patient's~     lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their~     tumor.~   "
271183|NCT00036413|"~     This study is the first to be performed in Amyotrophic Lateral Sclerosis (ALS) patients with~     the novel compound TCH346. Its purpose is to evaluate the safety and clinical effects of 3~     dose levels of TCH 346 compared to placebo in patients with a clinical diagnosis of~     laboratory-supported probable, probable or definite ALS. The study will require patients to~     visit the study center a total of at least 7 times over the course of up to 14 weeks. The~     study consists of 2 phases: A screening phase (up to 2 weeks) when patients will be evaluated~     for eligibility to participate in the study, and a double-blind treatment phase (12 weeks)~     when patients will receive daily doses of either TCH346 or placebo and will be evaluated for~     clinical effects. In addition, patients eligible to participate in this study will be~     required to have 3 magnetic resonance spectroscopic (MRS) scans. The MRS is a non-invasive,~     painless, brain scan. The MRS will require traveling to a designated center in Montreal,~     Canada, which is very experienced in performing such MRS scans in ALS patients.~   "
271184|NCT00036400|"~     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa on the~     reduction in red blood cell transfusions needed in gastric cancer patients and rectal cancer~     patients undergoing a treatment plan of preoperative chemotherapy and radiation therapy,~     followed by surgery.~   "
271185|NCT00036387|"~     The purpose of this study is to evaluate the safety and effectiveness of Infliximab~     (Remicade) in patients with Rheumatoid Arthritis. Infliximab (Remicade) targets specific~     proteins in the body's immune system to help control the development of inflammation to help~     reduce the pain of rheumatoid arthritis.~   "
271186|NCT00036374|"~     The purpose of this study is to evaluate the effectiveness and safety of infliximab~     (Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).~   "
271187|NCT00036361|"~     The purpose of this study is to learn if aripiprazole is effective in the treatment of a~     large number of persons diagnosed with schizophrenia or schizoaffective disorders~   "
271188|NCT00036348|"~     The purpose of this study is to learn if aripiprazole is effective in the treatment of~     patients with a history of bipolar disorder.~   "
271189|NCT00036335|"~     The purposes of this study are to determine whether an investigational drug can help patients~     suffering from major depression with pain symptoms, and gather data on the safety of the~     investigational drug including any side effects that might be associated with it.~   "
271190|NCT00036309|"~     The purpose of this study is to determine if duloxetine is effective when compared to placebo~     in preventing recurrence of major depressive disorder in patients who have responded to~     open-label duloxetine treatment.~   "
271191|NCT00036296|"~     The purpose of this research study is to test the safety and effectiveness of the study drug,~     Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a~     result of treatment to Parkinson's disease.~      It is not clear why people with Parkinson's disease develop involuntary movements~     (dyskinesias) but studies show that blocking receptors in the brain for a chemical called~     glutamate decreases these movements. Talampanel is a drug which blocks these receptors.~   "
271192|NCT00036283|"~     Reduction in size and number of oral premalignant lesions~   "
271193|NCT00036270|"~     To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given~     sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast~     cancer.~      This Pfizer sponsored trial is part of an international collaboration of investigators~     conducting 7 similar yet independent studies in 9 countries. This study is designed to be~     part of the larger TEAM trial where the data from these 7 studies will be combined. A~     pre-specified analysis of the pooled data will be conducted.~   "
271194|NCT00036257|"~     The purposes of this study are to determine a maximum tolerated dose and to evaluate the~     safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.~   "
271195|NCT00036244|"~     The purpose of the study is to determine whether multiple doses of secretin are safe and~     effective in the treatment of children with autism.~   "
271196|NCT00036231|"~     The purpose of the study is to determine the effect of multiple doses of secretin on autism.~   "
271197|NCT00036218|"~     The primary purpose of this study is to determine whether sumanirole is effective and safe in~     the treatment of the signs and symptoms of early Parkinson's disease.~   "
271198|NCT00036205|"~     The primary objective is to assess the long term safety and tolerability of sumanirole as~     measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects~     with Parkinson's Disease who participated in previous sumanirole studies.~   "
271199|NCT00036192|"~     The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic~     subjects receiving sulfonylurea (SU) monotherapy.~   "
271200|NCT00036179|"~     The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of~     patients with confirmed candidemia or invasive candidiasis.~   "
271201|NCT00036166|"~     The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with~     proven or probable invasive infections due to Aspergillus species.~   "
271202|NCT00036153|"~     The purpose of this study is to evaluate the efficacy of the combination of tacrolimus +~     methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of~     rheumatoid arthritis over 6 months in patients with partial response to methotrexate.~   "
271203|NCT00036140|"~     The primary goal of the study is to determine the best dose of an investigational drug to~     give to patients with multiple myeloma and to evaluate the investigational drug's~     effectiveness as a treatment for multiple myeloma.~   "
271204|NCT00036127|"~     Study to learn if the alternate formulation is effective in agitated schizophrenic patients~   "
271205|NCT00036114|"~     The purpose of this study is to learn if aripiprazole is safe and effective in the treatment~     of psychosis associated with dementia of the Alzheimer's type.~   "
271206|NCT00036101|"~     The purpose of this study is to learn if aripiprazole is effective for the treatment of~     patients with acute symptoms of Bipolar disorder.~   "
271207|NCT00036088|"~     The purpose of this study is to determine how Olanzapine compares to an active comparator in~     the treatment of schizophrenia~   "
271208|NCT00036075|"~     The purpose of this study is to investigate whether an investigational drug, CP-461, is safe~     and effective for the treatment of patients with prostate cancer and who have measurable~     disease.~   "
271211|NCT00036023|"~     Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red~     blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and~     shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone~     marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in~     the laboratory and has the same effect as the hormone produced by the body. Use of~     recombinant human erythropoietin allows the body to produce more red blood cells, possibly~     eliminating or decreasing your symptoms and the need for a red blood cell transfusion.~     Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving~     chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for~     the treatment of anemia in patients with non-myeloid malignancies who are receiving~     chemotherapy every three weeks. Darbepoetin alfa is a recombinant erythropoietic protein that~     stimulates the production of red blood cells. This medication has not been approved to treat~     cancer patients with anemia, however it has been approved by the FDA to treat chronic renal~     failure patients with anemia.~   "
271212|NCT00035997|"~     The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic~     acid for injection in 100mg solution ) has in preventing associated bone loss in prostate~     cancer patients with bone metastasis when administered in conjunction with hormonal cancer~     therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing~     bone mineral density in these patients.~      This prospective, open-label, single arm, multicenter study will enroll approximately 200~     prostate cancer patients with a history of at least one documented bone lesion documented by~     bone scan or radiograph. Patients must already be receiving hormone therapy and meet the~     following additional criteria:~        -  18 years of age or older~        -  Histologically confirmed diagnoses of prostate cancer~        -  Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or~          radiograph~        -  Received or will receive hormonal treatment also know as androgen deprivation therapy~          with an LHRH agonist or other hormonal treatments~      Throughout the course of this 12-month trial, patients will be identified based on the~     duration of established hormonal treatment at the time of enrollment. Each patients duration~     of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a~     4 week follow up.~   "
271213|NCT00035984|"~     This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on~     glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients~     will be randomized into one of two AC2993 treatment arms or to placebo treatment and will~     continue with their required existing diabetes medications (metformin and a sulfonylurea)~     throughout the study.~   "
271214|NCT00035971|"~     The purpose of this study is to determine how treatment with raloxifene compares to treatment~     with alendronate in postmenopausal women with osteoporosis on the chance of experiencing~     fractures~   "
271215|NCT00035958|"~     Juvenile dermatomyositis (JDMS) is one of the most serious of the childhood rheumatic~     diseases. The theory behind this trial is that early introduction of etanercept or~     methotrexate will prove to be effective in the treatment of JDMS. Pretreatment muscle~     biopsies, we believe there will be abnormalities in the blood vessels that will be correlated~     with worse physical strength and daily functional ability. The long-term goal is to improve~     the treatment of this serious childhood onset rheumatic disease and to better understand the~     pathogenic mechanism for the development of the vasculopathy (disorder of blood vessels) of~     JDMS. Identification of the specific mechanism of the vasculopathy may allow for the rational~     introduction of biologic treatments focused on vascular growth.~   "
271216|NCT00035945|"~     Purpose of this study is to evaluate the safety, tolerability, antiviral activity, and~     pharmacokinetic behavior of ISIS 14803 administered for up to 12 weeks by intravenous~     infusions in patients with chronic hepatitis C.~   "
271217|NCT00035932|"~     The purpose of this study is to learn how well atazanavir (ATV) works in combination with~     ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral~     load of treatment experienced subjects with human immunodeficiency virus (HIV). There is a~     comparison arm with lopinavir (LPV)/RTV and TDF and a nucleoside.~   "
271218|NCT00035919|"~     This is a Phase I safety study of a gene transfer drug for colorectal cancer that has spread~     to the liver. The main purpose of this study is to determine if it is safe to give this new~     intervention to persons with cancer, but we will also look for indications that the drug is~     effective. Although the findings in animals that have cancer are encouraging, this is the~     first time humans will receive this experimental gene transfer drug. A gene called cyclin G1~     has been shown to play a very important part in cancer growth. In animal experiments, a~     genetically modified virus (or vector)carrying a modified cyclin G1 gene caused the cancerous~     tumors to grow much slower or even die. In this safety study, the drug will be injected~     through the liver artery to get it near the cancer that has spread to the liver. The way the~     gene gets into the cancer cells is by using a targeted vector that concentrates in the area~     of the cancer to improve the delivery of the killing gene into cancer cells. The vector we~     are using is a virus that has been changed so that the infectious genes have been removed and~     instead carries the modified cyclin G1 gene.~   "
271219|NCT00035906|"~     The purpose of this clinical research study is to evaluate the safety and effectiveness of an~     investigational medication to treat macular edema that persists despite current treatment~     methods. Participants will be evaluated for improvement in vision and side effects.~      Macular edema is a condition that affects the back of the eye (retina). It frequently occurs~     in people who have a history of diabetes, and is also associated with high blood pressure,~     uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision,~     generally a blurring of central vision.~      There are no direct costs to participants for assessments and treatment as defined in the~     study protocol. All candidates must be available for required scheduled visits during the~     trial's 6-month follow-up period. Although the disease called age-related macular~     degeneration (AMD) affects the same region of the eye as macular edema, they are not the same~     condition and AMD is not studied in this research trial.~   "
271220|NCT00035893|"~     This is an open-label, prospective, randomized, controlled study of the safety and efficacy~     including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic~     Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR)~     and CD4 levels > 400.~   "
271226|NCT00035815|"~     The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I)~     slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study~     participants will be followed for 2 years once enrolled. They will receive either placebo or~     the active IGF-I. Examinations will take place at approximately 6-month intervals.~   "
271227|NCT00035802|"~     The purpose of this study is to determine the safety and efficacy of topiramate in~     adolescents with manic or mixed episodes of Bipolar I Disorder.~   "
271228|NCT00035789|"~     The purpose of this clinical research study is to assess the safety and effectiveness of~     entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B~     infection who are hepatitis B e antigen negative.~   "
271229|NCT00035776|"~     To investigate associations between hemostatic and inflammatory blood factors and progression~     of lower extremity arterial ischemia and cardiovascular events in men and women with and~     without lower extremity peripheral arterial disease.~   "
271230|NCT00035763|"~     To measure the variability in pain and response to pain in sickle cell disease, and to build~     multivariate models to explain both patients' pain and their response to pain, especially,~     utilization of health care.~   "
271231|NCT00035750|"~     To determine risk factors for atherogenesis in Type 1 diabetes.~   "
271232|NCT00035737|"~     To investigate the role of endothelial dysfunction and increased vascular stiffness as~     contributors to the pathogenesis of cardiovascular disease.~   "
271233|NCT00035724|"~     To examine temporal trends from 1995 and 2000 in the incidence rates of heart failure, its~     therapeutic management, and changes over time in the hospital and long-term survival of~     patients with heart failure.~   "
271234|NCT00035711|"~     To evaluate additional cardiovascular risk factors using data from the VA HDL Intervention~     Trial (VA-HIT).~   "
271235|NCT00035698|"~     To identify genes involved in obesity.~   "
271236|NCT00035685|"~     To examine whether or not primary school-aged children with asthma from low-income households~     have lower household environmental tobacco smoke (ETS) exposure than matched control~     children.~   "
271237|NCT00035672|"~     To evaluate how current genetic information about cardiovascular disease susceptibility genes~     contributes to the prediction of future cardiovascular disease outcomes.~   "
271238|NCT00035659|"~     To study the natural history of the accumulation of intra-abdominal fat as women progress~     through the menopause.~   "
271239|NCT00035633|"~     The purpose of this clinical research study is to assess the safety effectiveness of~     entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B~     infection who are hepatitis B e antigen positive.~   "
271240|NCT00035620|"~     Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a~     type of bone cancer that can be treated with chemotherapy which can affect the bone marrow,~     where blood cells are produced. Neutrophils are a type of white blood cells that fight~     infection and are produced in the bone marrow. If the neutrophil count becomes too low due to~     chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is~     serious because it can affect the body's ability to protect against many types of infections.~     Pegfilgrastim is an investigational drug being evaluated for its potential ability to~     increase the number of neutrophils. The purpose of this study is to determine the safety and~     effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric~     patients up through the age of 21 with sarcoma.~   "
271241|NCT00035607|"~     This study is investigating darbepoetin alfa for the treatment of anemia in patients with~     non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein~     that stimulates the production of red blood cells. In this study, darbepoetin alfa will be~     administered as either an injection under the skin (subcutaneously) or directly into a vein~     (intravenously).~   "
271242|NCT00035594|"~     Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast~     cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells~     are produced. Neutrophils are a type of white blood cells that fight infection and are~     produced in the bone marrow. If the neutrophil count becomes low due to chemotherapy, a~     potentially serious condition called neutropenia occurs. Neutropenia is serious because it~     can affect the body's ability to protect against many types of infections. Pegfilgrastim is~     an investigational drug being evaluated for its potential ability to increase the number of~     neutrophils. The purpose of this study is to determine the safety and effectiveness of~     pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced~     breast cancer.~   "
271243|NCT00035581|"~     This is an open-label, prospective, randomized, controlled study of the safety and efficacy~     including clinical, immunologic, and virologic assessments of adding Ampligen to HAART in~     HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml~     (PCR).~   "
271244|NCT00035568|"~     The purpose of this clinical research study is to support earlier observations that~     Glucovance controls glucose levels after a mean, and improves overall glucose control better~     than metformin or glyburide therapy alone in adults with type 2 diabetes.~   "
271245|NCT00035555|"~     The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is~     as efficacious as treatment with cyclosporine at preventing acute rejection and with a~     superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid~     problems, less diabetes mellitus).~   "
271246|NCT00035542|"~     The purpose of this clinical research study is to see if Glucovance, a medication currently~     approved for use in adults with type 2 diabetes, can control type 2 diabetes safely and~     effectively in children 9 to 16 years of age.~   "
271247|NCT00035529|"~     The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis~     disease activity on MRI examinations, as well as decrease the rate of clinical MS~     exacerbations, compared to placebo~   "
271248|NCT00035516|"~     The purpose of this clinical research study is to learn if BMS-247550 can shrink or slow the~     growth of the cancer in patients with non-small cell lung cancer who have failed first-line~     platinum based chemotherapy. The safety of this treatment will also be studied.~   "
271249|NCT00035503|"~     The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the~     treatment of acute Crohn's disease.~   "
271250|NCT00035490|"~     Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular~     tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the~     heart. ICD therapy is established as highly effective for stopping life-threatening~     arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to~     decrease the frequency of ICD shocks.~      The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of~     ICD shocks has been investigated previously in a placebo-controlled study in patients with~     ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled~     study with approximately 600 patients.~   "
271251|NCT00035477|"~     Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common~     supraventricular arrhythmia (abnormal heart rhythm) for which antiarrhythmic therapy is often~     prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm)~     and to reduce the occurrence of episodes of atrial fibrillation. Azimilide may have an effect~     on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial~     flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal~     heart rhythms).~      This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety~     of azimilide compared with placebo in maintaining sinus rhythm in patients who require~     cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. Once~     this phase of the study is completed, a second phase with a different study design will be~     conducted. The second phase is an open-label follow-up phase to the study. This follow-up~     phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of~     azimilide in patients who complete the double-blind, placebo-controlled phase of this study.~   "
271252|NCT00035464|"~     Atrial fibrillation (an abnormal rhythm in the upper chamber of the heart) is a common~     supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic~     therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm~     (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.~     Azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial~     fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other~     types of abnormal heart rhythms).~      This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety~     of azimilide compared with placebo in prolonging the time to the first symptomatic arrhythmia~     recurrence in patients with a history of atrial fibrillation and congestive heart failure~     and/or ischemic heart disease) and those without these conditions. Once this phase of the~     study is completed, a second phase with a different study design will be conducted. The~     second phase is an open-label, follow-up phase. The follow-up phase of the study is designed~     to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients~     who complete the double-blind, placebo-controlled phase of this study.~   "
271253|NCT00035451|"~     Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common~     supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic~     therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm~     (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.~      The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy~     and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug,~     in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct~     heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a~     second phase with a different study design will be conducted. The second phase is an~     open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate~     the long-term safety of a daily oral dose of azimilide in patients who complete the~     double-blind, placebo-controlled phase of this study.~   "
271254|NCT00035438|"~     The purpose of this study is to determine the effectiveness of St. John’s Wort as compared to~     placebo (an inactive substance) in the treatment of outpatients with obsessive compulsive~     disorder.~   "
271255|NCT00035425|"~     This study will treat patients who have fever and neutropenia (after cancer chemotherapy)~     that is possibly due to a specific bacteria (gram positive bacteria).~   "
271256|NCT00035412|"~     The purpose of this study is to determine the effectiveness of St. John’s Wort as compared to~     placebo (an inactive substance) in the treatment of outpatients with social phobia.~   "
271257|NCT00035399|"~     This study will examine the efficacy of acupuncture in combination with exercise physical~     therapy for moderate osteoarthritis (OA) of the knee.~   "
271258|NCT00035360|"~     This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron,~     1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients~     compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added~     to stable optimized background antiretroviral therapy in this patient population.~   "
271259|NCT00035347|"~     A trial in which patients over 18 years of age who are hospitalized with community acquired~     pneumonia and are otherwise eligible for entry into the study are randomly selected to~     receive one of two treatment regimens. After written informed consent is obtained, patients~     will receive one of the following two treatment regimens: 1) intravenous administration of~     azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous~     administration of levofloxacin followed by levofloxacin tablets. At least four study visits~     are normally conducted up to approximately one month after starting therapy. The objective of~     this study is to compare the safety and efficacy of the two treatment regimens.~   "
271276|NCT00035152|"~     Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small~     cell lung carcinoma.~      This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where~     it is given weekly.~      The purpose of the study is to determine the most effective and safe schedule for giving~     these drugs in non small cell lung carcinoma.~   "
271299|NCT00034827|"~     CI-1040 is an experimental drug that is being tested in patients who have advanced colorectal~     and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who~     have failed no more than 2 prior regimens and in patients with pancreatic cancer who have~     received no prior chemotherapy. CI-1040 is taken orally twice daily with meals. Patients are~     required to have blood tests periodically while receiving treatment and will be monitored~     closely throughout the trial for possible side effects and for response.~   "
271260|NCT00035386|"~     This study will test the feasibility of a modified procedure for treating obstructive~     hypertrophic cardiomyopathy (OHC). Patients with OHC have a thickening of the heart muscle~     that obstructs blood flow out of the heart, causing breathlessness, chest pain, palpitations,~     tiredness, lightheadedness, and fainting.~      The current treatment for OHC is a procedure called alcohol septal ablation (also~     percutaneous transluminal septal ablation, or PTSA), which involves injecting a small amount~     of alcohol into a tiny artery that supplies the part of muscle causing blood flow~     obstruction. The success of PTSA is limited, however, by problems of heart anatomy and the~     ability to find the appropriate artery to inject. Modifying the procedure by injecting the~     alcohol through the wall of the lower right chamber of the heart may improve its safety and~     effectiveness. The new technique requires positioning a catheter (a flexible tube) into the~     appropriate area of the heart. This study will test the ability to accurately guide the~     catheter to that area.~      Patients with OHC 18 years of age and older who are scheduled to have a cardiac~     catheterization may be eligible for this study. At the end of the catheterization procedure,~     participants will undergo intra-cardiac echocardiographic imaging. For this test, one of the~     catheters placed in the femoral artery (at the top of the leg) for cardiac catheterization~     will be substituted for a larger one. Through this catheter, a special catheter will be~     introduced and advanced to the heart to provide images. This pilot feasibility study does not~     involve injection of alcohol.~   "
271261|NCT00035373|"~     The objective of this study is to evaluate patients with tumors of the central nervous system~     (CNS) for eligibility in the National Cancer Institute s research studies. These patients~     will undergo a series of procedures, usually including a complete medical history and~     physical examination; laboratory testing of blood, CSF, urine, bone marrow, or other samples;~     an evaluation of tumor location and size by x-rays, CT (computed tomography) or MRI (magnetic~     resonance imaging) scans, or nuclear medicine scans; lumbar puncture; electrocardiogram and~     echocardiogram; and procedures to evaluate the function of specific organs. A bone marrow~     biopsy is occasionally performed. Research samples may also be collected and stored to avoid~     having to do a painful test more than once. Tissue specimens collected during this process~     may be stored and used in future studies.~      Patients of both genders, any age, and all racial and ethnic groups with tumors of the CNS or~     a history of a CNS tumor are eligible. Up to 100 people are expected to participate.~      The physician will discuss the results of these procedures with the patient and his or her~     family. On the basis of the eligibility screening and the patient s wishes, the patient may~     then be enrolled in a primary research protocol.~   "
271262|NCT00035334|"~     The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to~     placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical~     improvement/worsening of both renal and gastrointestinal functions.~   "
271263|NCT00035321|"~     The purposes of this study are to determine:~        -  Whether olanzapine plus fluoxetine in combination will help patients with~          treatment-resistant major depression.~        -  The safety of olanzapine plus fluoxetine in combination, plus and any side effects that~          might be associated with the combination.~        -  The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine~          alone.~   "
271264|NCT00035308|"~     The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and~     effective in delaying and reducing renal flares in patients with lupus nephritis.~   "
271265|NCT00035295|"~     A clinical study to determine the efficacy and safety of an Treatment of MK0869~      in the treatment of depression.~   "
271266|NCT00035282|"~     A clinical study to determine the efficacy and safety of an investigational medication~     (MK0869) in the treatment of depression.~   "
271267|NCT00035269|"~     This study will treat patients who have a community-acquired pneumonia that is due to a~     specific bacteria (S. pneumoniae)~   "
271268|NCT00035256|"~     The purpose of this study is to determine whether the increase in spine bone mineral density~     that has been generally observed in previous clinical studies involving the study drug can be~     maintained or even increased if followed with raloxifene HCl. All qualifying study~     participants will receive the study drug followed by treatment with raloxifene HCl or~     placebo. All study participants will receive raloxifene HCl in the third phase of the study.~   "
271269|NCT00035243|"~     This study will examine whether the investigational drug EPO906, given by intravenous~     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the~     growth of cells that cause kidney cancer.~   "
271270|NCT00035230|"~     The primary purpose of this study is to evaluate the safety and efficacy of topiramate~     compared with placebo in the treatment of acute manic or mixed episodes in patients with~     Bipolar I Disorder.~   "
271271|NCT00035217|"~     There is controversy concerning the preferred treatment for men with localized prostate~     cancer with regard to the relative effectiveness of different treatments in controlling the~     cancer and how different treatments affect the patient's quality of life. The purpose of this~     research is to describe the disease course of prostate cancer and to determine the~     effectiveness, potential complications, and quality of life after different treatments in men~     with prostate cancer detected via screening with prostate-specific antigen (PSA) and/or~     digital rectal examination~   "
271272|NCT00035204|"~     The purpose of this study is to evaluate the relative effects of galantamine compared to~     donepezil (both cholinesteraste inhibitors), on sleep, attention, and gastrointestinal~     tolerance in patients with Alzheimer's disease.~   "
271273|NCT00035191|"~     This is a trial to evaluate the safety and effectiveness of galantamine in patients with~     dementia secondary to blood vessel disease in the brain.~   "
271274|NCT00035178|"~     The primary goals of this investigation are to provide guidance on how to dose Argatroban in~     patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in~     hemodialysis patients. The secondary goal of the study will be to assess the adequacy of~     anticoagulation during hemodialysis.~   "
271275|NCT00035165|"~     This study will examine whether the new investigational drug EPO906, given by intravenous~     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the~     growth of cells that cause melanoma.~   "
271302|NCT00034788|"~     The purpose of this study is to evaluate the efficacy and safety of REGRANEXÂ® Gel compared~     with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers~     of the ankle or foot related to diabetes.~   "
271277|NCT00035139|"~     Traumatic Brain Injury (TBI) is the leading cause of acquired long term disability among~     children and young adults. Deficits in attention and memory are common and persist for years~     after moderate or severe TBI. The similarity between these symptoms and those of children~     with AD/HD, the efficacy of methylphenidate in the treatment of AD/HD, and the efficacy of~     methylphenidate in improving recovery of animals with brain injuries, support the need to~     study methylphenidate effects in children with TBI. This investigation of methylphenidate in~     children with moderate to severe TBI aims to: (1) Assess the acute effects of 2 different~     dosages of methylphenidate on attention and reaction time when the medication is administered~     to children early in recovery; (2) Assess the ability of 8 weeks of methylphenidate to~     improve the rate of recovery of cognitive, memory, and attentional skills in children with~     TBI; (3) Identify the frequency of common methylphenidate side effects in children with TBI.~   "
271278|NCT00035126|"~     This study will examine whether the investigational drug EPO906, given by intravenous~     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the~     growth of cells that cause breast cancer.~   "
271279|NCT00035113|"~     This study will examine whether the new investigational drug EPO906, given by intravenous~     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the~     growth of cells that cause prostate cancer.~   "
271280|NCT00035100|"~     This study will examine whether the new investigational drug EPO906, given by intravenous~     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the~     growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the~     United States is complete but the study is still enrolling in other countries.~   "
271281|NCT00035087|"~     This study will examine whether the new investigational drug EPO906, given by intravenous~     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the~     growth of cells that cause colorectal cancer.~   "
271282|NCT00035074|"~     Patients with inflammatory bowel disease (IBD) who require methotrexate (MTX)for treatment~     currently receive this drug by injection. MTX is also available as a pill that can be given~     by mouth but it is not known how well the drug enters the body in patients with Crohn's~     disease or ulcerative colitis. This study is being done to compare how much MTX enters the~     body when the drug is taken by mouth compared to when it is given by injection. If the drug~     is well absorbed, it may allow patients to receive the drug by mouth.~   "
271283|NCT00035061|"~     Patients with bladder cancer will be participating in this study for the treatment of~     abnormal cells in the bladder that have returned after initial treatment OR have moved to a~     new site in the body.~   "
271284|NCT00035048|"~     A clinical study to determine the efficacy and safety of an investigational medication~     (MK0869) in the treatment of depression.~   "
271285|NCT00035035|"~     Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA~     for the treatment of cancer of the pancreas. Patients may be able to participate in this~     study if they have cancer in their pancreas that cannot be removed by surgery OR that has~     spread to a new site in their body.~   "
271286|NCT00035022|"~     The purpose of this study is to determine if intravenous BCX-1777 can be given safely to~     improve relapsed or refractory aggressive T-cell leukemias and lymphomas.~   "
271287|NCT00035009|"~     A clinical study to determine the efficacy and safety of MK0869 in the treatment of~     depression~   "
271288|NCT00034983|"~     A clinical study to determine the efficacy and safety of an investigational medication~     (MK0869) in the treatment of depression~   "
271289|NCT00034970|"~     The purpose of this study is to determine whether cancer patients who receive the~     mindfulness-based art therapy (MBAT) program demonstrate improvement in health-related~     quality of life, a reduction in stress-related symptoms, and enhanced coping responses.~   "
271290|NCT00034957|"~     The primary goal of the study is to evaluate an investigational drug's effectiveness as a~     treatment for Non small-cell lung cancer (NSCLC)~   "
271291|NCT00034944|"~     A clinical study to determine the efficacy and safety of MK0869 in the treatment of~     depression.~   "
271292|NCT00034918|"~     The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic~     breast cancer at 2 dose levels.~   "
271293|NCT00034905|"~     The purpose of this study is to show equal efficacy of both quetiapine and risperidone in~     subjects treated with study medication for up to 8 weeks.~   "
271294|NCT00034892|"~     The purpose of this study is to compare the effectiveness, tolerability, and efficacy of the~     currently available atypical antipsychotic drugs olanzapine (2.5-20 mg/day), quetiapine~     (100-800 mg/day) and risperidone (0.5-4 mg/day) in patients with schizophrenia,~     schizophreniform disorder, or schizoaffective disorder who are experiencing their first~     psychotic episode.~   "
271295|NCT00034879|"~     A program for patients with non small cell lung cancer who may benefit from Iressa, but~     cannot enter another clinical trial due to them not being eligible, or for whom no trials are~     available.~   "
271296|NCT00034866|"~     The purpose of this research study is to determine which of three different dose combinations~     of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is~     most effective and safe. Tipranavir is an investigational protease inhibitor which has been~     demonstrated to have in vitro activity against HIV-1.~   "
271297|NCT00034853|"~     To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral~     suspension in children with Juvenile Rheumatoid Arthritis (JRA)~   "
271298|NCT00034840|"~     The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically~     superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed~     dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to~     demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the~     last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active~     study medication at the end of a 6 to 8-week treatment period.~   "
271300|NCT00034814|"~     To compare seizure frequency in patients with refactory partial seizures (with or without~     generalization) who are taking Talampanel versus placebo as an add-on therapy to other~     licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in~     this group of patients.~   "
271301|NCT00034801|"~     This is a research study comparing the safety and efficacy of two active study medications~   "
271307|NCT00034723|"~     This study will use three different magnetic resonance imaging (MRI) techniques to study~     HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/STP)-a disease of slowly~     progressive weakness in the legs. It is not known how the HTLV-1 virus causes this disease,~     but it is thought that as the body's immune system tries to destroy the virus, parts of the~     nervous system-primarily the spinal cord-are damaged.~      Patients 18 years of age and older with HAM/TSP and healthy normal volunteers may be eligible~     for this study.~      Participants will undergo diffusion tensor MRI, MR-spectroscopy, and magnetization transfer~     imaging to look at different compositional, architectural, and microscopic properties of the~     brain. All of these techniques are similar to conventional MRI, and like the conventional~     method they use a strong magnetic field and radio waves to measure structural and chemical~     changes in brain tissue. Each of the three scans will be done on separate days, each lasting~     about 1 hour. For the procedures, the patient or volunteer lies on a stretcher in a narrow~     metal cylinder (the scanner) and is asked to remain still for 15 to 30 minutes at a time. A~     special lightweight coil may be placed on the head to enhance the brain images. The subject~     can communicate with the person doing the scan at all times.~   "
271308|NCT00034710|"~     The purpose of this study is to gain initial information on the tolerability of high-dose~     capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also~     collect preliminary information on safety and efficacy.~   "
271309|NCT00034697|"~     Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually.~     Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain~     radiation and steroids will improve neurologic symptoms in about 50% of patients although~     survival is short. This study will test the safety and efficacy of temozolomide in~     combination with radiation therapy in the treatment of patients with brain mets form nonsmall~     cell lung cancer.~   "
271310|NCT00034684|"~     The purpose of this study is to determine the safety and tolerability of an oral Farnesyl~     Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced~     Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast~     Crisis, or Acute Lymphoblastic Leukemia.~   "
271311|NCT00034671|"~     This phase II study will be conducted to:~        1. evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing~          schedules of Posaconazole in immunocompromised hosts with a variety of refractory~          invasive fungal infections or in subjects who require empiric antifungal therapy and~        2. identify the dosing schedule that provides the most consistent therapeutic drug exposure~          in this patient population.~   "
271312|NCT00034658|"~     This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH~     56592) under an open label, treatment protocol for subjects with invasive fungal infections:~      A: which are refractory or resistant to standard antifungal therapies; B: for which there are~     currently no effective therapies; C: with a prior history of serious, severe or~     life-threatening toxicities while receiving antifungal therapy; D: with pre-existing organ~     dysfunction which precludes the administration of standard antifungal therapies.~   "
271313|NCT00034645|"~     This trial is in high risk patients to determine the safety, tolerance and efficacy of~     posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal~     infections (IFI).~   "
271314|NCT00034632|"~     This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH~     56592) under an open label, treatment protocol for subjects with invasive fungal infections:~      A. which are refractory or resistant to standard antifungal therapies; B. for which there are~     currently no effective therapies; C. with a prior history of serious, severe or~     life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ~     dysfunction which precludes the administration of standard antifungal therapies.~   "
271315|NCT00034619|"~     The purpose of this study is to assess the antitumor activity of ALIMTA plus Oxaliplatin~     combination therapy in patients with previously untreated advanced colorectal cancer~   "
271316|NCT00034606|"~     The purpose of the study is to measure tumor response rates for three schedules of~     Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or~     metastatic non small cell lung cancer who have received no prior chemotherapy regimen.~   "
271317|NCT00034593|"~     Definition: Patients with bladder cancer will be participating in this study for the~     treatment of abnormal cells in the bladder that have returned after initial treatment OR have~     moved to a new site in the body.~   "
271318|NCT00034580|"~     This is a research study comparing the safety and efficacy of two active study medications~     for the treatment of bipolar I disorder.~   "
271319|NCT00034567|"~     This project will focus on the development and testing of efficient, cost effective measures~     that are specifically designed for use in Alzheimer's Disease (AD) primary prevention trials.~   "
271320|NCT00034554|"~     Up to 24 patients with stage III or stage IV melanoma will be enrolled. Patients who are~     currently disease-free but at high risk for relapse are also eligible. Patients will receive~     vaccinations of gp75 at assigned dose levels. Patients who exhibit serologic and~     stable/clinical response are eligible to receive booster vaccinations. Patients will be~     evaluated for safety and efficacy throughout the duration of the study. In this study, the~     optimal biologically effective dose is defined as the lowest dose of gp75 that results in the~     production of anti-gp75 antibodies.~   "
271321|NCT00034541|"~     The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small~     cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin~     and paclitaxel for two cycles or until disease progression or until the patient exhibits~     intolerable toxicities. Patients will be evaluated for efficacy and safety throughout the~     duration of the study.~   "
271322|NCT00034528|"~     The purpose of this study is to find out if using a lower dose of chemotherapy before stem~     cell transplantation can cure patients of sickle cell anemia or thalassemia while causing~     fewer severe side effects than conventional high dose chemotherapy with transplantation.~   "
271323|NCT00034515|"~     The purpose of this ascending dose group study is to assess the safety, tolerability, and~     effects of multiple dose levels of INS37217 and placebo followed by five days twice daily~     treatment with maximum tolerated dose administered by inhalation via the Pari LC Star~     nebulizer in adult and pediatric patients with cystic fibrosis~   "
271324|NCT00034502|"~     This is a non-randomized study in patients who have received prior 5-FU therapy for~     colorectal cancer. The objective of this trial is to establish a maximum tolerated dose of~     ALIMTA and irinotecan given in combination as well as to assess the safety and efficacy of~     this combination for patients with locally advanced or metastatic colorectal cancer. ALIMTA~     and irinotecan will be given every 21 days.~   "
271325|NCT00034489|"~     This is a study to explore how well the combination of LY231514 and Gemcitabine work together~     in patients with breast cancer that has spread beyond the location of the original tumor.~     Patients must have previously received treatment with anthracycline and taxane chemotherapy~     drugs.~   "
271326|NCT00034476|"~     The purpose of this study is to determine whether the administration of the study drug is~     effective in increasing the chance of survival in patients with severe sepsis. Patients~     entered into this study will be randomly assigned to one of two treatment groups. Patients in~     each treatment group will be given either the study drug or placebo as a continuous infusion~     directly into the bloodstream through a catheter placed in one of the patient's veins.~      The study drug is an investigational drug that is still in development. It has been studied~     in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or~     arthritis, and approximately 600 patients with severe sepsis. Patient participation in this~     study will last for about one month.~   "
271327|NCT00034463|"~     This is a non-randomized, phase 1, study with the primary objective of determining the~     toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10~     minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in~     lightly or heavily pre-treated patients with locally advanced or metastatic cancer.~   "
271328|NCT00034450|"~     L-carnitine is a supplement (type of vitamin) that has been suggested to be decreased in~     patients with cancer. We will identify patients that have terminal cancer and fatigue. The~     purpose of this study is to determine if L-carnitine replacement improves fatigue in cancer~     patients with L-carnitine deficiency.~   "
271329|NCT00034437|"~     This study will evaluate immune responses against cytomegalovirus (CMV). About 80 percent of~     adults have been exposed to this virus. CMV typically remains dormant (inactive) in the body,~     causing no problems. In people with immune suppression, however, the virus can become~     reactivated and cause life-threatening pneumonia. The knowledge gained from this study may be~     useful in developing ways to improve immune responses to CMV in stem cell transplant~     recipients.~      Healthy normal volunteers between 18 and 65 years of age who have been exposed to~     cytomegalovirus are eligible for this study. Candidates will be screened with a medical~     history and blood tests. Those enrolled will provide a 30-milliliter (6-tablespoon) blood~     sample once a week for 4 weeks and a final sample 2 months later. The blood will be used to~     design a test to detect immune responses against CMV and determine the differences in these~     responses among healthy individuals.~   "
271330|NCT00034424|"~     Background:~      People with a family history of testicular cancer may be at increased risk for the disease.~      Genetic and clinical studies of patients with testicular cancer and their family members may~     help clarify the cause of the disease and identify clinical features.~      Objectives:~      To characterize the clinical features of testicular cancer.~      To identify genes that may lead to increased risk of the disease.~      To examine emotional and behavioral issues of members of families at increased risk of the~     disease.~      Eligibility:~      Males and females from a family with at least two cases of testicular cancer in blood~     relatives.~      Males with testicular cancer in both testicles.~      Males with testicular cancer who have an identical twin.~      Participants must be at least 12 years of age.~      Design:~      Participants may take part in Part 1 or Parts 1 and 2 of this 2-part study.~      Part 1 participants:~        -  Provide a blood or cheek cell sample to obtain DNA for gene studies.~        -  Provide permission for researchers to obtain their medical records for review.~        -  Complete questionnaires about their personal and family medical history, exposure to~          factors that might influence the risk of testicular cancer, and their feelings about~          being a member of a family in which several members have testicular cancer.~        -  These data are collected from participants in their home communities.~      Part 2 participants:~        -  All participants provide a medical history, have a complete physical examination,~          including routine lab tests, and have an ultrasound test of the abdomen to look at the~          kidneys.~        -  Males have an ultrasound test of the testicles and scrotum.~        -  Females have an ultrasound test of the pelvis to look at the ovaries, uterus and~          fallopian tubes.~        -  Males 18 years of age and older provide a semen sample.~        -  Some participants have computed tomography (CT) scanning of the chest, abdomen and~          pelvis instead of kidney ultrasound. Children under 18 years of age may have magnetic~          resonance imaging (MRI) instead of CT.~        -  These data are collected from participants during a 2-day visit to the NIH Clinical~          Center in Bethesda, MD. Travel costs are covered by the protocol.~   "
271331|NCT00034398|"~     This study will investigate how the brain generates tics in patients with Tourette's syndrome~     and which areas of the brain are primarily affected. Tourette's syndrome is a~     neuropsychiatric disorder characterized by motor and vocal tics, and is associated with~     behavioral and emotional disturbances, including symptoms of attention deficit hyperactivity~     disorder and obsessive-compulsive disorder. This study will examine whether tic generation is~     related to changes in brain cell receptors for a chemical messenger called gamma-aminobutyric~     acid (GABA).~      Healthy normal volunteers and patients with Tourette's syndrome between 21 and 65 years of~     age may be eligible for this study. Candidates will be screened with a medical history and~     physical and neurological examinations.~      Participants will undergo positron emission tomography (PET) scanning to measure brain blood~     flow. For this procedure, the subject receives an injection of H215O, a radioactive substance~     similar to water. A special camera detects the radiation emitted by the H215O, allowing~     measurement of the blood flow. Subjects will receive up to five injections of H215O during~     the scanning. They will also be injected with another radioactive chemical, (11C) flumazenil,~     which binds to GABA receptors, to measure the density and distribution of these receptors.~     This will reveal which areas of the brain in patients with Tourette's syndrome have abnormal~     binding of flumazenil compared with the brains of healthy control subjects.~      During the PET procedure, the subject lies on a table in the PET scanner. A small catheter~     (plastic tube) is placed in an arm vein for injecting the radioactive tracers, and a mask is~     placed on the face to help keep the head still during scanning. The mask has large openings~     for eyes, nose and mouth, so that it does not interfere with talking or breathing. The entire~     test takes about 3 hours.~      On a separate day, participants will also undergo magnetic resonance imaging (MRI), a~     diagnostic test that uses a magnetic field and radio waves to produce images of the brain.~     For this procedure, the subject lies still on a stretcher that is moved into the scanner (a~     narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by~     electrical switching of radio frequency circuits used in the scanning process. The scan lasts~     about 45 to 60 minutes.~   "
271341|NCT00034268|"~     The purposes of this study are to determine:~        1. If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer,~          compared with gemcitabine and cisplatin alone.~        2. The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be~          associated with the combination of these three drugs.~        3. Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or~          disappear, and for how long, compared with gemcitabine and cisplatin alone.~      It is possible that information collected during this study will be analyzed by the sponsor~     in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or~     for other medical or scientific purposes other than those currently proposed.~      LY900003 may not add any benefit to gemcitabine plus cisplatin.~   "
271342|NCT00034255|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     doses of intramuscular INGAP Peptide given for the first time in humans as a potential~     treatment for diabetes.~   "
271332|NCT00034385|"~     This study will compare different ways of giving the drugs ganciclovir and valganciclovir to~     kidney or kidney and pancreas transplant recipients to determine the most effective dose of~     valganciclovir for protecting against cytomegalovirus (CMV) infection in these patients. One~     of the most common viral infections following organ transplant, CMV can cause serious illness~     and even death.~      Ganciclovir reduces the incidence of CMV disease after kidney transplantation. The drug is~     given either intravenously (through a vein) twice a day or by mouth 3 times a day.~     Valganciclovir is converted to ganciclovir in the body and is absorbed into the bloodstream~     better than oral ganciclovir. In most transplant patients, a single daily dose of~     valganciclovir prevents CMV. Because of these advantages, some transplant patients are being~     given valganciclovir instead of ganciclovir to prevent CMV infection. However, the drug has~     not been studied in kidney and kidney transplant patients. This study will provide dosing~     information for this patient population.~      Patients 18 years of age and older who have had a kidney or kidney and pancreas transplant at~     the NIH Clinical Center may be eligible for this study. Participants will undergo the~     following treatments and procedures:~      - Phase 1 - Treatment with intravenous ganciclovir for at least 7 days after transplantation.~      Sometime before starting phase 2, patients will provide a 24-hour urine collection to test~     for kidney function. The day before starting phase 2, they will have a cannula (small needle)~     inserted into an arm vein for about 12 hours to draw blood samples-one before starting the~     ganciclovir infusion, then at 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 12 hours after~     the dose.~        -  Phase 2 - Treatment with oral valganciclovir once a day for 7 to 21 days at a dose~          approximately equivalent to intravenous ganciclovir. Sometime between 4 and 21 days on~          this dose, patients will have blood sampling in the morning before taking the drug and~          then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours after the dose.~        -  Phase 3 - Treatment with valganciclovir at a dose reduced by half to approximate oral~          ganciclovir dosing.~      After at least 4 days on this dose, patients will be admitted to the hospital for 1 day for~     blood sampling before the drug dose and then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours~     after the dose. Kidney function will be assessed by blood tests within 2 days of the blood~     sampling. If kidney function is not within the normal range, further dosing and blood~     sampling will be delayed until kidney function returns to the normal range.~      - Phase 4 - Treatment with oral ganciclovir every 8 hours. After at least 4 days on this~     regimen, patients will be admitted to the hospital for 1 day for blood sampling before the~     drug dose and then at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after the dose. Kidney function will~     be estimated by blood tests within 2 days of the blood sampling. If kidney function is not~     within the normal range, further dosing and blood sampling will be delayed until kidney~     function returns to normal range.~      After completing phase 4, patients will continue valganciclovir daily or oral ganciclovir~     treatment and blood sampling for a length of time prescribed by the transplant surgeon.~   "
271333|NCT00034372|"~     In this study, patients will be randomized to one of three dose regimen groups. Each dose of~     OvaRex MAb-B43.13 is 2 mg by slow intravenous administration.~      Group 1 will receive two doses, one month apart.~      Group 2 will receive three consecutive monthly doses, then at 12-week intervals through 2~     years or until disease relapse up to a total of 9 doses.~      Group 3 will receive six consecutive monthly doses, then at 12-week intervals through 2 years~     or until disease relapse up to a total of 11 doses.~      The study will compare the time to disease relapse of patients who demonstrate an immune~     response to OvaRex MAb-B43.13 with time to disease relapse of those who do not demonstrate an~     immune response to OvaRex MAb-B43.13. Differences in the percentage of patients demonstrating~     an immune response in each dose regimen group will also be assessed.~   "
271334|NCT00034359|"~     The purpose of this study is to determine the safety and anti-HBV activity of ACH-126, 443~     (beta-L-Fd4C) in comparison to lamivudine or placebo in treatment naive adults with chronic~     Hepatitis B infection.~   "
271335|NCT00017862|"~     This study will examine the safety and effectiveness of a single dose of anti-interleukin-5~     antibody (SCH 55700) in reducing the number of eosinophils (a type of white blood cell) in~     patients with hypereosinophilic syndrome. Patients with this disease have too many~     eosinophils in the blood and in body tissues, which cause damage to the affected organs-most~     commonly the heart, nerves and skin. SCH 55700 is an antibody to interleukin 5-a hormone-like~     substance produced by white blood cells that plays a significant role in eosinophilia. SCH~     55700 has lowered eosinophilia blood counts in patients with asthma and reduced the number of~     these cells in tissues of animals with asthma.~      Patients with hypereosinophilic syndrome 18 years of age and older who have not responded to~     standard therapy with steroids, interferon and hydroxyurea or cannot take these drugs may be~     eligible for this study. Candidates will be screened with a medical history, physical~     examination, eye examination, and blood tests. Depending on the patient's symptoms, other~     diagnostic tests may be done, including studies of the eyes, lungs, skin, nerves or heart.~     Skin biopsy and bronchoalveolar lavage may be included in the diagnostic evaluation. For the~     skin biopsy, a small area about 1/3 inch in diameter is numbed and a small core of skin is~     surgically removed for study under the microscope. Bronchoalveolar lavage involves inserting~     a catheter (flexible tube) into the lungs to instill saline (salt water) and obtain a tissue~     sample. This test will be done only if clinically necessary.~      Those enrolled in the study will be admitted to the NIH Clinical Center for a single dose of~     SCH 55700, injected into an arm vein. They will be monitored in the hospital for at least 72~     hours for changes in eosinophil count and side effects of the injection. After discharge,~     laboratory tests will be done weekly for the first month, either at the Clinical Center or by~     the patient's local physician. Follow-up visits will then be scheduled monthly for 1 year or~     until the patient's eosinophil count returns to pre-treatment levels for 2 consecutive~     months. Follow-up visits will include a history, physical examination and blood tests,~     including studies on how immune cells and other substances in the blood activate or stimulate~     eosinophilia. A chest X-ray, electrocardiogram and pulmonary function tests will be done at~     1, 3, 6 and 12 months to evaluate organ damage. Other tests may be done if medically~     indicated.~      Bone marrow biopsy and aspiration will be done before receiving SCH 55700 and one month after~     the injection to evaluate the effects of SCH 55700 on eosinophil production in the bone~     marrow. For this test, an area of skin and bone is numbed and a very sharp needle is used to~     withdraw a sample of the bone marrow. Leukapheresis will also be done before and 1 month~     after SCH 55700 treatment to obtain cells for studying the effect of SCH 55700 on eosinophil~     activation, function and survival. For this procedure, whole blood is collected through a~     needle in an arm vein. The blood circulates through a machine that separates it into its~     components. The white cells are then removed, and the rest of the blood is returned to the~     body, either through the same needle used to draw the blood or through a second needle placed~     in the other arm.~   "
271336|NCT00034346|"~     Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in~     kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor~     prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor~     types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth.~     Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal~     antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a~     Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in combination with~     paclitaxel and carboplatin in the treatment of advanced NSCLC.~   "
271337|NCT00034333|"~     MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to stick, to~     magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is~     added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and~     deposited in the area of a tumor, where it is thought that it then leaks through the blood~     vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes free~     from the magnetic beads and will then be able to act against the tumor cells. The iron~     component of the particle has magnetic properties, making it possible to direct MTC-DOX to~     specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that~     MTC-DOX used with the magnet may target the chemotherapy directly to liver tumors and provide~     a treatment to patients with liver cancer.~      To be sure of the effect of MTC-DOX on liver cancer, it will be compared to the effect of~     Doxorubicin given through the vein.~      The study treatments will be administered every three weeks, (which is considered a study~     treatment cycle), until you complete six treatment cycles, the tumor grows, disappears, or~     you experience a side effect, which may cause you to leave the study. Follow-up visits will~     occur on Days 3, 10, and 21 following treatment in the first cycle and Days 7 and 21 for the~     remaining cycles, and also 60 days after you receive your last treatment cycle.~      Therefore, the purpose of this Phase 2/3 study is to evaluate safety, tolerance, and efficacy~     (survival time) of an MTC-DOX dosing strategy where the DOX dose is determined by tumor size~   "
271338|NCT00034307|"~     This is a clinical research study designed to evaluate an investigational new medication~     called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA~     functional class II, III or IV). The purpose of this study is to evaluate the safety and~     effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment)~     for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be~     eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive~     placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.~   "
271339|NCT00034294|"~     Approximately 300 patients will be entered into this study taking place throughout the United~     States, Canada and the United Kingdom. This study aims to determine if an investigational~     drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and~     lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated~     in comparison to current standard antibiotic treatment, so all patients will receive active~     medication.~      All study-related care is provided including doctor visits, physical exams, laboratory tests~     and study medication. Total length of participation is approximately 10 weeks.~   "
271340|NCT00034281|"~     The purpose of this study is to investigate a safe dose of TAK-165, once daily (QD), in~     patients with HER2-tumor expression.~   "
271343|NCT00034203|"~     The purpose of this study is to determine whether a humanized monoclonal antibody~     (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.~   "
271344|NCT00034190|"~     Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly~     S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or~     IV colorectal adenocarcinoma.~   "
273146|NCT00013156|"~     Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve~     quality of life in patients with COPD, but to date no controlled studies have evaluated the~     impact of LVRS.~   "
271345|NCT00034177|"~     Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly~     S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced,~     metastatic, or recurrent transitional cell carcinoma of the urothelium.~   "
271346|NCT00034242|"~     This study will examine whether high-dose intravenous immunoglobulin (IVIG) is safe and~     effective for treating cerebellar ataxia-degeneration of the cerebellum, the part of the~     brain responsible for coordinating muscle movements and balance. The disease causes a slowly~     progressive impairment of speech and balance, with patients often developing slurred speech,~     tremor, clumsiness of the hands, and walking difficulties (ataxia). IVIG is derived from~     donated blood that has been purified, cleaned and processed into a form that can be infused.~     IVIG is an immune suppressant that is routinely used to treat other neurological conditions.~      Patients 18 years of age and older with hereditary (genetic) or sporadic (unknown cause)~     cerebellar degeneration may be eligible for this 5-month study. They must have evidence of an~     immune component to their condition, such as gluten sensitivity or antiganglioside~     antibodies. Candidates will be screened with a neurological examination, a review of medical~     records and possibly blood tests.~      Participants will be randomly assigned to receive infusions of either IVIG or placebo (an~     inactive substance) through an arm vein once a month for two months. The infusions will be~     given in the hospital in doses divided over 2 days, each lasting 6 to 10 hours. Before the~     infusions, patients will undergo ataxia assessments through tests of coordination and balance~     that may involve finger tapping, walking in a straight line, talking, and eye movements. When~     the treatment is finished, patients will be followed in the clinic once a month for 3 months~     for blood tests repeat ataxia assessments to evaluate the effects of treatment.~   "
271347|NCT00034229|"~     The purpose of this study is to evaluate the safety and effectiveness of the drug felbamate~     for treating depression in patients with bipolar disorder that has not responded to standard~     treatments.~      Bipolar disorder is a severe, chronic, and often life-threatening illness. Despite the~     availability of a wide range of antidepressant drugs, a proportion of patients fail to~     respond to first-line antidepressant treatment despite adequate dosage, duration, and~     compliance. Studies suggest that the glutamatergic system may play a role in the~     pathophysiology and treatment of depression. Felbamate and other agents which reduce~     glutamatergic neurotransmission may represent a novel class of antidepressants.~      Participants in this study will be admitted to the Clinical Center for up to 10 weeks. At~     study entry, participants will have a 7-day washout period in which they will be tapered off~     all psychiatric medications, with the possible exception of lithium, and will be given a~     placebo (an inactive pill). After the washout period, participants will be randomly assigned~     to receive either felbamate or placebo for 8 weeks. Participants whose depression symptoms~     worsen by more than 30% or those for whom study continuation is considered potentially~     harmful will be taken off the study and offered open-label treatment. Participants who~     received felbamate and responded well to treatment will have the option of continuing~     treatment.~   "
271348|NCT00034216|"~     This study will collect blood from patients with cancer to study the level of cells which~     decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18~     years of age and older with cancer may participate. This study does not involve treatment.~      Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their~     condition, patients may be invited to enroll in a clinical research study involving~     chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during~     the course of treatment.~   "
271349|NCT00034164|"~     Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly~     S-8184 paclitaxel injectable emulsion in second line treatment of patients with relapsed~     stage IIIB or IV non small cell lung cancer.~   "
271350|NCT00034151|"~     Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly~     S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or~     IV platinum resistant ovarian cancer or primary peritoneal carcinoma.~   "
271351|NCT00034138|"~     The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product~     and OvaRex MAb-B43.13 cell culture product. Safety and immune responses following treatment~     with the cell culture product will be evaluated.~   "
271352|NCT00034125|"~     To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with~     advanced or metastatic breast cancer.~   "
271353|NCT00034112|"~     The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is~     effective for persons with emphysema as a component of their chronic obstructive pulmonary~     disease.~   "
271354|NCT00034086|"~     The purpose of this study is to see how the body's immune system changes after replacing and~     adding new anti-HIV drugs to a patient's current anti-HIV therapy. This study will also see~     whether adding drugs is safe. Patients who take part in A5136 are also eligible to take part~     in 2 substudies. The purpose of substudy A5140s is to see how many latently infected cells~     (cells in which the HIV virus survives) are in the lymph node (small, rounded structures that~     make disease-fighting cells). Substudy A5155s will be performed to see how many latently~     infected cells are in the blood before and after replacing and adding anti-HIV drugs.~      ACTG A5136 is a follow-up study to ACTG 315 and ACTG 375, which were designed to examine the~     effects of highly active antiretroviral therapy (HAART) in certain HIV-infected patients.~     Many HIV-infected patients have undergone long-term anti-HIV therapy and have had the virus~     suppressed. However, most of these patients still have problems with their immune systems.~     The reason for these problems is unknown. This study may help researchers understand what~     causes immune system problems in people who have low levels of HIV in their blood.~   "
271378|NCT00033202|"~     Gimatecan® is sigma-tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this~     class play a crucial role in destroying DNA replication in tumors. We are conducting this~     study to determine the Maximum Tolerated Dose of our compound, when given as a capsule,~     rather than by intravenous injection.~   "
271395|NCT00032981|"~     The purpose of this study is to evaluate the therapeutic usefulness of incorporating~     Motivational Enhancement Treatment into the standard drug abuse treatment entry process of~     Community Treatment Programs on improving treatment engagement, retention, and outcome.~   "
271396|NCT00032968|"~     The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient~     opiate detoxification.~   "
271355|NCT00034073|"~     This study will use magnetic resonance imaging (MRI) to examine how blood flow to the brain~     differs at different ages with the brain is at rest, and during performance of tasks that~     involve language, memory, motor control, and sight. The study will evaluate the usefulness of~     MRI in identifying language function and location, and may provide information on how the~     brain develops over time to process brain functions, such as language and memory.~      Healthy normal volunteers in three age groups-children 8-10, adolescents 13-16, and young~     adults 21-30-may be eligible for this study. Participants must be right-handed and be native~     English speakers. Candidates will be screened via a telephone interview and examination by a~     neurologist.~      Participants will undergo MRI scanning of the brain during rest or while performing a task~     designed to test a skill. The tasks may involve remembering numbers, reading a word, tapping~     fingers, or looking at a flashing picture. MRI uses a magnetic field and radio waves to~     produce pictures of the brain. For the procedure, the subject lies still on a table that is~     moved into the scanner (a cylinder containing the magnet). Earplugs are worn to muffle loud~     noises caused by electrical switching of radio frequency circuits used in the scanning~     process. Adults may spend as long as 90 minutes in the scanner, usually less than 45 minutes.~     For children, the time is less than 75 minutes-usually 30 to 40 minutes. Participants may be~     asked to repeat the scans up to 5 times in different sessions to test different brain~     functions or confirm findings.~   "
271356|NCT00034060|"~     This study has two phases. Phase 1 will examine the role of inflammatory mediators called~     cytokines on growth hormone levels in women with rheumatoid arthritis (RA). Phase 2 will~     evaluate the effect of etanercept on these growth hormone levels. Etanercept is approved for~     the treatment of RA. It lowers the levels of a key inflammatory mediator called tumor~     necrosis factor-alpha and is very effective in reducing arthritis symptoms.~      Growth hormone promotes bone and muscle growth. With aging, people lose muscle mass and bone~     strength, possibly because of decreased levels of growth hormone. People with RA have bone~     and muscle changes similar to those in older people, perhaps also due to decreased levels of~     growth hormone. The first part of this study will see if the inflammatory mediators~     responsible for joint inflammation (warmth, redness, pain, and swelling) in RA are related to~     the lowered growth hormone levels in this disease. The second part will evaluate the effect~     of etanercept treatment on muscle mass and bone density, in addition to growth hormone~     levels.~      Premenopausal women between 18 and 55 years of age with a recent diagnosis of rheumatoid~     arthritis (less than 3 years) are eligible for this study. Healthy volunteers will also be~     enrolled in the first phase of the study as control subjects. This study is conducted at two~     sites, the NIH and the Johns Hopkins Medical Center in Baltimore.~      Healthy volunteers enrolled in this study will be interviewed about their health status and~     will fill out questionnaires on diet and general physical function, including fatigue, energy~     and well being. In addition, they will be hospitalized once at the NIH Clinical Center for~     24-hour blood sampling and will visit to Johns Hopkins Medical Center in Baltimore for a~     brachial artery reactivity study, as follows:~        -  24-hour blood sampling for growth hormone levels. Blood samples (1/2 teaspoon each) will~          be collected every 20 minutes from 8 AM one day until 8 AM the following day through a~          plastic tube in an arm vein.~        -  Dual energy X-ray absorptiometry (DEXA) scan on a small area of the spine, hip and wrist~          to assess bone density and a total body DEXA scan to assess the amount and distribution~          of muscle and body fat.~        -  Blood vessel (brachial artery reactivity) study to measure the ability of the brachial~          artery to dilate and increase its blood flow. For this procedure, the subject lies on a~          table with electrocardiogram leads attached to the chest. A blood pressure cuff is~          inflated for several minutes and a drop of nasal spray of nitroglycerin is given that~          may cause a headache. Blood pressure and headache are monitored and treated as needed.~      Patients with rheumatoid arthritis will be seen at the NIH clinic on six separate visits~     (weeks 0, 1, 6, 12, 18, and 26) over 26 weeks. Week 0 is a screening visit. At weeks 1 and~     26, patients will be admitted to the hospital for 24-hour blood sampling, DEXA scans, and~     brachial artery reactivity tests, as described above, plus X-rays of the hand and feet. After~     the first visit, they will start taking etanercept, given by self-injection under the skin~     (like insulin shots) twice a week. Follow-up visits at weeks 6, 12, and 18 will involve~     evaluations of disease activity and drug side effects through joint examination, blood tests,~     and questionnaires.~   "
271357|NCT00034047|"~     This 36-week study will determine whether traditional Chinese medicine (acupuncture and~     Chinese herbs) is as effective as hormone therapy for alleviating endometriosis-related~     pelvic pain.~   "
271358|NCT00034034|"~     This study investigates the effect of acupuncture in reducing symptom distress in adults with~     advanced colon cancer.~   "
271359|NCT00034021|"~     The purpose of this study is to provide the first empirical examination of the effects of~     Ginkgo biloba (GBE), sex therapy, and a combination of the two on subjective and~     physiological measures of sexual function in women who are experiencing sexual disorders~     secondary to antidepressants.~   "
271360|NCT00034008|"~     The purpose of this project is to evaluate whether or not Healing Touch therapy (HT) helps to~     treat the stress of babies in the Neonatal Intensive Care Unit (NICU). Healing Touch is a~     gentle use of human touch – a light, soft placement without moving of the HT therapist’s hand~     on a baby’s body - and energy to create balance and relaxation. The goal of HT treatment is~     to help babies rest better, have less pain and discomfort and to heal more quickly. Healing~     Touch works along with all the treatments and medicines babies receive as part of ordinary~     care in the NICU.~   "
271361|NCT00033995|"~     This study will investigate which areas of the brain are primarily involved in and~     responsible for tics in patients with Tourette's syndrome and chronic motor disorder.~     Tourette's syndrome is a neuropsychiatric disorder characterized by motor and vocal tics and~     is associated with behavioral and emotional disturbances, including symptoms of attention~     deficit hyperactivity disorder and obsessive-compulsive disorder. Chronic motor disorder has~     the same characteristics as Tourette's syndrome, except that patients do not have vocal tics.~      Healthy normal volunteers and patients with Tourette's syndrome or chronic motor tic disorder~     between 18 and 65 years of age may be eligible for this study. Candidates will be screened~     with a medical history and physical and neurological examinations.~      Participants will undergo positron emission tomography (PET) scanning to study tics under~     three conditions- spontaneous tics, suppression of tics, and sleep-to determine which areas~     of the brain are responsible for generation of tics. For this procedure, the subject is~     injected with H215O, a radioactive substance similar to water. A special camera detects the~     radiation emitted by the H215O, allowing measurement of brain blood flow. Subjects will~     receive up to 20 injections of H215O during the scanning.~      Participants will be asked not to sleep the entire night before the test. Before the scan,~     both patients and volunteers will have EEG electrodes placed on their heads to record the~     electrical activity of their brains. Patients will also have EMG electrodes placed in areas~     of the body where tics occur. A small catheter (plastic tube) will be placed in an arm vein~     for injecting the radioactive tracers, and a mask will be placed on the face to help keep the~     head still during scanning. The mask has large openings for eyes, nose and mouth, so that it~     does not interfere with talking or breathing. The entire test takes about 4 hours. During~     this time, the subject will sleep for 1.5 hours either at the beginning or end of the scan.~     For the other 2.5 hours, scans will be done every 10 minutes for 1 minute under the different~     conditions of tic suppression or release of tics.~      On a separate day, participants will also undergo magnetic resonance imaging (MRI), a~     diagnostic test that uses a magnetic field and radio waves to produce images of the brain.~     For this procedure, the subject lies still on a stretcher that is moved into the scanner (a~     narrow cylinder containing the magnet). ...~   "
271362|NCT00033982|"~     This study will evaluate the safety and effectiveness of posaconazole for treating invasive~     fungal infections. New therapies for these infections are needed for patients who do not~     respond, to or cannot tolerate, standard treatment. These patients include those with immune~     defects who have significant side effects from treatment with amphotericin or other~     antifungals.~      Patients 13 years of age or older who are on other primary NIH protocols with an invasive~     fungal infection 1) that does not respond to standard antifungal therapies; 2) for which~     there is no effective therapy; 3) who develop serious side effects from their current~     treatment; or 4) who have organ dysfunction that does not permit use of standard antifungal~     treatments may be eligible for this study. Candidates will be screened with a medical~     history, including a review of current and previous antifungal treatments, pregnancy test for~     women of childbearing potential, electrocardiogram (EKG), and detailed neurologic~     examination.~      Participants will take either 200 mg (1 teaspoonful) of liquid posaconazole by mouth four~     times a day or 400 mg (two teaspoonfuls) twice a day for a period of 28 days to 24 months.~     (The physician will determine the duration of treatment.) Patients will have monthly~     follow-up visits during the treatment period and 1 month after treatment is completed for the~     following procedures:~        -  Detailed neurologic exam every 3 months~        -  Blood tests every month~        -  EKG every month~        -  Imaging studies, including chest x-ray, computed tomography (CT), magnetic resonance~          imaging (MRI) radionuclide scanning or ultrasound, every month until the infection has~          been stable for three determinations. Thereafter, imaging studies will be done every 3~          months as long as the infection remains stable or improves.~      On the last day of the study treatment period, participants will have a detailed neurologic~     exam and review of medications and medical complaints since their last visit.~   "
271376|NCT00033774|"~     This study will examine the development of stem cells (very immature cells produced by the~     bone marrow) and their potential to change into cells of other organ types. These cells will~     be studied for their potential use in creating replacement tissue for diseases ranging from~     diabetes to Parkinson s.~      Healthy volunteers 18 years of age or older may be eligible for this study. Candidates will~     be screened with a medical history, physical examination, and blood tests.~      Participants will undergo a process called 'stem cell mobilization and apheresis' to collect~     bone marrow stem cells. For five days before the collection they will receive injections of a~     hormone called G-CSF, which stimulates release of stem cells from the bone marrow into the~     bloodstream. On the fifth day of the injections, stem cells will be collected through~     apheresis. For this procedure, blood is collected through a catheter (plastic tube) placed in~     an arm vein and directed into a cell separator machine. There, the white cells and stem cells~     are separated from the other blood components through a spinning process and collected in a~     bag inside the machine. The rest of the blood is returned to the donor through a catheter in~     the other arm.~   "
271377|NCT00033215|"~     To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy~     accessible cancer who have failed previous therapy or to whom no standard therapies are~     available. To determine the pharmacokinetic profile of S-3304 in this patient population~   "
271363|NCT00033969|"~     This study will try to learn more about complex regional pain syndrome, or CRPS (previously~     known as reflex sympathetic dystrophy, spreading neuralgia, and sympathalgia), by examining~     the release of small proteins in the blood of patients with this condition. Patients with~     CRPS usually have three types of symptoms:~        -  Sensory abnormalities increased sensitivity to pain or a painful reaction to a harmless~          stimulus~        -  Perfusion abnormalities alterations in blood flow, temperature abnormality, swelling,~          decrease or increased nail growth, and hair and skin changes~        -  Motor abnormalities weakness, guarding (Holding the limb in such a fashion that it~          minimizes accidental or intentional contact from possible sources of pain), and atrophy~          (wasting)~      The cause of CRPS is unknown, and there are no definitive diagnostic tests for the condition.~     Because early treatment improves the prognosis of CRPS, a test that enables early diagnosis~     would be important for optimal medical management. The findings of this study may contribute~     to the development of such a test and possibly new drug treatments.~      Normal healthy volunteers and patients of any age with complex regional pain syndrome who are~     in otherwise good general health may be eligible for this study.~      Participants will have a medical history, physical examination and collection of a blood~     sample. They will fill out several questionnaires, providing information on their health,~     personality, mood, pain levels, and symptoms. Participation in the study requires one~     outpatient clinic visit.~   "
271364|NCT00033956|"~     The clinical use of IL-2 is currently limited by development of dose-dependent hypotension~     (systolic blood pressure (SBP) < 90 mm Hg). The overall outcome is constant across sites with~     20-50% of the patients requiring ICU management because of unresponsive hypotension and~     hyporeactivity (loss of response to vasoconstrictors). Because of the dose-limiting side~     effects, the duration of IL-2 dosing is frequently curtailed. Thus, hemodynamic toxicities~     have limited the usefulness of IL-2 therapy. M40403 has prevented both the hypotension and~     hyporeactivity associated with IL-2 treatment in preclinical studies. This trial will study~     the safety and efficacy of M40403 in the prevention or reduction of hypotension in patients~     receiving IL-2 therapy.~   "
271365|NCT00033943|"~     This study will evaluate the effectiveness and safety of the experimental compound OP2000~     (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study~     will have received (and will continue to receive) stable doses of aminosalicylates (oral,~     enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with~     anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the~     treatment of ulcerative colitis.~   "
271366|NCT00033917|"~     The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in~     the brain of very low birth weight preterm infants.~   "
271367|NCT00033904|"~     Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected,~     locally advanced renal cell carcinoma have improved recurrence-free survival as compared to~     subjects with no adjuvant treatment.~   "
271368|NCT00033891|"~     This study will examine whether infliximab (Remicade ) is safe and effective for the~     treatment of dermatomyositis and polymyositis. Infliximab blocks the effect of a protein~     called tumor necrosis factor (TNF), which is associated with harmful inflammation in many~     diseases.~      Patients 18 years of age and older with active dermatomyositis or polymyositis that does not~     respond adequately to treatment with methotrexate and corticosteroids may be eligible for~     this study. Candidates will be screened with a medical history, physical examination, blood~     and urine tests, chest x-ray, pulmonary function test, skin test for tuberculosis, HIV test,~     electromyography (described below), manual muscle testing, and functional assessments.~     Magnetic resonance imaging (described below) will be done to assess the degree and location~     of inflammation in the involved limbs. An electrocardiogram and echocardiogram will be done~     if recent ones are not available. Patients who qualify for the study will be asked to undergo~     two muscle biopsies (surgical removal and analysis of small pieces of muscle tissue), one~     before initiation of treatment and another on the 16th week .~      Participants will be randomly assigned to receive either 3 mg/kg body weight of infliximab or~     a placebo (inactive substance) by infusion through a vein over 2 hours. The infusions will be~     given at the beginning of the treatment period (week 0) and at weeks 2, 6 and 14. At week 16,~     strength will be assessed by manual muscle testing. Patients who improved with treatment will~     continue with the same infusion dose on weeks 18, 22, 30, and 38. Those who do not improve~     will be assigned by random allocation to receive either 5 mg/kg body weight or 10/mg/kg body~     weight of infliximab on weeks 18, 22, 30 and 38. Those who did not improve who were~     previously on the placebo infusion will receive an extra dose of either 5 mg/kg or 10 mg/kg~     body weight of infliximab on week 16, while those patients who were previously on 3 mg/kg~     body weight of infliximab who failed to meet the improvement criteria will receive an~     infusion containing no medication on week 16. Patients will be admitted to the hospital for~     infusions at weeks 0, 14 and 38; the rest will be given on an outpatient basis. After the~     38th week, all infusions will be stopped and patients will be assessed on the 40th week.~      Participants will undergo some or all of the following tests and evaluations during~     treatment:~        -  Blood tests every week to look for antibodies seen with muscle inflammation. Some of the~          blood samples will be stored for later testing, including genetic studies to find~          genetic differences related to inflammation.~        -  Skin test for tuberculosis~        -  Chest x-rays at the beginning of the study (if a recent one is not available) and again~          at weeks 16 and 40 to look for active infection, detect signs of past exposure or~          infection with diseases such as tuberculosis, and assess the presence of lung disease~          that might be related to the myositis.~        -  MRI (usually of the legs) at the beginning of the study and again at weeks 16 and 40 to~          measure disease activity and extent of muscle involvement. This will also give an idea~          of the response to treatment. This test uses a magnetic field and radio waves to produce~          images of body tissues. During the procedure the patient lies on a bed surrounded by a~          metal cylinder (the scanner).~        -  Muscle biopsy at the beginning of the study to diagnose muscle inflammation and again at~          week 16 to evaluate the response to treatment.~        -  Electromyography if the patient has not had an EMG previously. For this test, small~          needles are inserted into the muscle to assess the electrical activity of the muscle~        -  HIV test~      Patients whose disease worsen with treatment or who develop serious drug-related side effects~     will be taken off the study and referred back to their primary care physician for further~     therapy. Patients who improve will be referred back to their primary physician at the end of~     the study for possible continued treatment. Participants will be asked to return for~     follow-up visits every 6 weeks for a total of 30 weeks to monitor long-term effects of the~     drug~   "
271369|NCT00033878|"~     The purpose of this Phase 1 study is to: 1. determine the maximum tolerated dose of capsules~     containing 500mg of freeze dried noni fruit extract, 2. define toxicities associated with the~     ingestion of noni, 3. collect preliminary information on the efficacy of noni in respect to~     anti-tumor and symptom control properties to help select specific patients for subsequent~     Phase 2 studies, 4. identify chemical constituents of the extract that can be used to~     characterize the bioavailability and pharmacokinetics of noni food supplement.~   "
271370|NCT00033865|"~     The purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for~     insomnia using yoga, relaxation exercises or sleep hygiene.~   "
271371|NCT00033852|"~     The purpose of this study is to determine the effect of massage therapy on depression,~     quality of life and plasma cortisol levels in subjects with advanced HIV disease.~   "
271372|NCT00033839|"~     This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in~     the treatment of an episodic cluster headache period compared to placebo (medically inactive~     substance which does not contain any active ingredients).~   "
271373|NCT00033826|"~     Vitamin D is a fat soluble vitamin that has important effects on calcium (including~     absorption of calcium from the diet) and bone metabolism. Vitamin D is known to be stored in~     fat tissue, and it is also present in the circulation. The purpose of this study is to~     investigate the relationship between levels of vitamin D in fat tissue and in blood.~   "
271374|NCT00033813|"~     This study will help to determine the safety and efficacy of the mast cell stabilizer~     Oxatomide as a treatment for Duchenne muscular dystrophy (DMD). Boys with DMD who are~     enrolled in this study will should not have taken steroids to treat DMD for at least twelve~     months, and should not have taken any nutritional supplements for at least three months.~     Subjects will complete a two screening visits within a one-week period, and if enrolled will~     then have their strength tested monthly for three months before beginning therapy with~     Oxatomide. Once Oxatomide therapy is started, participants will have their strength tested~     monthly for six months. Following the six month treatment period, participants will be given~     the option to remain on Oxatomide until the study is completed.~   "
271375|NCT00033787|"~     Serotonin is a chemical involved in regulation of emotions, anxiety, sleep, stress hormones,~     and other body functions. The purpose of this study is to use a procedure called tryptophan~     depletion to study the function of serotonin in people with depression and in healthy~     volunteers.~      Major depressive disorder (MDD) has been associated with reduced functioning of central~     serotonergic systems. Tryptophan depletion (TD) is a procedure used to investigate the~     relationship between serotonergic function and depression. Evidence suggests that the mood~     lowering effects of TD depend upon family history and differences in genes for a specific~     protein called 5-HTTLPR. Healthy females with a particular gene for 5-HTTLPR and a family~     history of mood disorders appear to be at a greater risk for the development of depressive~     symptoms during TD. This study will use positron emission tomography (PET) scans of the brain~     to investigate the effect of variant 5-HTTLPR genotypes on response to TD. The relationship~     between 5-HTTLPR genotypes and the effect of TD on brain activity in individuals with~     different 5-HTTLPR genes will be determined. This study will also examine how the reduced~     serotonin function that occurs in MDD affects the brain's response to sensory stimulation.~      Participants in this study will be screened by telephone about their psychiatric and medical~     history, current emotional state, anxiety and sleep patterns, and family history of~     psychiatric disorders. At study entry, participants will have an interview, physical~     examination, electrocardiogram (EKG), and blood and laboratory tests. Menstruating women will~     have a pregnancy test and tests to determine menstrual phase and time of ovulation. At the~     second clinic visit, participants will undergo tests of intelligence and cognitive abilities~     and a magnetic resonance imaging (MRI) scan of the brain. Prior to Visits 3 and 4,~     participants will collect their saliva and urine. Menstruating women will have a pregnancy~     test. At Visits 3 and 4, participants will undergo TD studies and PET scanning. During one of~     these visits, participants will take capsules of an amino acid. On the other day, they will~     take lactose capsules. Throughout the study, participants will be asked about their emotional~     state, anxiety, ability to concentrate, and well being.~   "
271379|NCT00033189|"~     This study will help to determine the safety and efficacy of the nutritional supplement~     Coenzyme Q10 when added to steroids as a treatment for Duchenne muscular dystrophy (DMD).~     Boys with DMD who are enrolled in this study will should be on a stable dose of steroids for~     at least six months, and will remain on their usual dose throughout the study. They will~     complete two screening visits within a one-week period, and if enrolled will then have their~     strength tested monthly for three months before beginning therapy with Coenzyme Q10. Once~     Coenzyme Q10 therapy is started, participants will have their strength tested monthly for six~     months. Following the six month treatment period, participants will be given the option to~     remain on Coenzyme Q10 until the study is completed.~   "
271380|NCT00033176|"~     The purpose of this study is to determine the immunomodulatory and antiviral effects of the~     glutathione-restoring dithiol, alpha lipoic acid (ALA) in HIV-infected persons unresponsive~     to highly active antiretroviral treatment (HAART).~   "
271381|NCT00033163|"~     Control of hepatitis B virus (HBV) infection can be difficult in HIV infected people who have~     taken the antiviral lamivudine (3TC). These people may have HBV that has become resistant to~     3TC. Adefovir dipivoxil (ADV) has shown promising anti-HBV activity in clinical trials;~     tenofovir disoproxil fumarate (TDF) is used to treat HIV and may also be effective against~     HBV. The purpose of this study is to find out if adding ADV or TDF to a highly active~     antiretroviral therapy (HAART) regimen that includes 3TC has an effect on HBV infection in~     patients coinfected with HIV and HBV. The tolerability and safety of these drugs will be~     examined.~   "
271382|NCT00033150|"~     Brief Summary:~      Nearly 7% of elementary school children present with difficulties learning and using~     language. Unfortunately, language impairments are often long lasting and may have serious~     social, academic, and vocational ramifications. More than 1 million children receive language~     intervention in the public schools each year, and many more are seen in hospitals and other~     clinical settings.~      This randomized clinical trial compares the language outcomes of Fast ForWord to two other~     interventions (computer assisted language intervention without acoustically modified speech~     and individual language intervention) and to the outcomes of an academic enrichment (control)~     condition. Each year for 3 years, children will be randomly assigned to each of the four~     conditions at three regional sites (Austin, Texas, Dallas, Texas, and Lawrence, Kansas). The~     treatments will be administered in special summer programs. The primary research question is~     which intervention results in the most improvement in the composite language score from the~     Oral and Written Language Scales. Secondary questions include which intervention results in~     the greatest gains in conversational language,which intervention results in the greatest~     gains 3 and 6 months after training, which intervention results in the greatest improvement~     in auditory perception, and which intervention is the most cost effective.~      The results of the study will have theoretical and practical value. Theoretically, the study~     tests the temporal processing hypothesis of language impairment. Practically, the study will~     describe and compare the language, communication, auditory processing and academic outcomes~     of different language interventions. The study will help clinicians and administrators choose~     the most effective and least expensive treatment for the children they serve.~   "
271383|NCT00033137|"~     This study will investigate the genetic cause of Birt Hogg-Dube (BHD) syndrome and the~     relationship of this disorder to kidney cancer. BHD is a rare inherited condition~     characterized by papules, or bumps benign tumors involving hair follicles on the head and~     neck. People with BHD are at increased risk of developing kidney cancer. Scientists have~     identified the chromosome (strand of genetic material in the cell nucleus) that contains the~     BHD gene and the region of the gene on the chromosome. This study will try to learn more~     about:~        -  The characteristics and type of kidney tumors associated with BHD~        -  The risk of kidney cancer in people with BHD~        -  Whether more than one gene causes BHD~        -  The genetic mutations (changes) responsible for BHD~      Patients with known or suspected Birt Hogg-Dube syndrome, and their family members, may be~     eligible for this study. Candidates will be screened with a family history and review of~     medical records, including pathology reports for tumors, and films of computed tomography~     (CT) and magnetic resonance imaging (MRI) scans.~      Participants may undergo various tests and procedures, including the following:~        -  Physical examination~        -  Review of personal and family history with a cancer doctor, cancer nurses, kidney~          surgeon, and genetic counselor~        -  Chest and other x-rays~        -  Ultrasound (imaging study using sound waves)~        -  MRI (imaging study using radiowaves and a magnetic field)~        -  CT scans of the chest and abdomen (imaging studies using radiation)~        -  Blood tests for blood chemistries and genetic testing~        -  Skin evaluation, including a skin biopsy (surgical removal of a small skin tissue sample~          for microscopic evaluation)~        -  Cheek swab or mouthwash to collect cells for genetic analysis~        -  Lung function studies~        -  Medical photography of skin lesions~      These tests will be done on an outpatient basis in either one day or over 3 to 4 days. When~     the studies are complete, participants will receive counseling about the findings and~     recommendations. Patients with kidney lesions may be asked to return periodically, such as~     every 3 to 36 months, based on their individual condition, to document the rate of~     progression of the lesions.~   "
271384|NCT00033124|"~     The purpose of this study is to examine behavioral treatment for methamphetamine dependence.~   "
271385|NCT00033111|"~     The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence~   "
271386|NCT00033098|"~     The purpose of this study is to examine the safety of two consecutive days of metyrapone~     (MRP) in subjects who may use cocaine concurrently.~   "
271387|NCT00033085|"~     The purpose of this study is to assess the efficacy and safety of ondansetron to reduce~     cocaine use in subjects with cocaine dependence.~   "
271388|NCT00033072|"~     The purpose of this study is to assess the potential interactions between intravenous~     methamphetamine and oral selegiline.~   "
271389|NCT00033059|"~     The purpose of this study is to assess the potential interactions between intravenous (IV)~     cocaine and tolcapone.~   "
271390|NCT00033046|"~     The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its~     interactions with intravenous (IV) cocaine.~   "
271391|NCT00033033|"~     The purpose of this study is to assess the efficacy and safety of reserpine for the treatment~     of cocaine dependence.~   "
271392|NCT00033020|"~     The purpose of this study is to test the utilization of incentive values (considerably lower~     than those typically used in research clinics) to motivate clients to attend treatment and~     initiate and sustain abstinence.~   "
271393|NCT00033007|"~     The purpose of this study is to test the utilization of incentive values (considerably lower~     than those typically used in research clinics) to motivate clients to attend treatment and~     initiate and sustain abstinence.~   "
271394|NCT00032994|"~     The purpose of this study is to assess Motivational Interviewing (MI) to improve treatment~     engagement and outcome in subjects seeking treatment for substance abuse.~   "
271397|NCT00032955|"~     The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient~     opiate detoxification.~   "
271401|NCT00032903|"~     Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this~     class play a crucial role in destroying DNA replication in tumors. We are conducting this~     study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess~     the drug's ability to affect the evolution of malignant gliomas, when given as a capsule,~     rather than by intravenous injection.~   "
271402|NCT00032890|"~     This study will determine whether glucosamine, chondroitin sulfate and/or the combination of~     glucosamine and chondroitin sulfate are more effective than placebo and whether the~     combination is more effective than glucosamine or chondroitin sulfate alone in the treatment~     of knee pain associated with osteoarthritis (OA) of the knee after six months of follow-up.~     These substances, marketed in the United States as dietary supplements, have been widely~     touted by the lay press and by anecdotal personal experience as effective in treating OA. To~     date, however, only a few small studies have been published in the worldwide literature. The~     study proposed herein has been carefully constructed to definitively determine the efficacy~     of these agents.~   "
271403|NCT00032877|"~     This study will examine blood or other tissue samples from patients with Fraser syndrome and~     patients with Fryns syndrome to try to identify the gene responsible for these diseases.~     Fraser syndrome is characterized by congenital abnormalities including cryptophthalmos (lack~     of eyelid formation), syndactyly (webbed fingers or toes) and abnormal genitalia. Patients~     may also have abnormalities of the nose, ears and larynx (voice box), cleft lip or palate,~     and kidney agenesis. Fryns syndrome is characterized by hernia through the diaphragm, cloudy~     cornea, coarse facial features, cleft lip or palate, abnormal fingers and toes, heart, kidney~     and brain malformations and hydrocephalus (accumulation of fluid around the brain). This~     protocol consists of laboratory study only; it does not involve patient care or patient~     counseling.~      Patients with Fraser syndrome or Fryns syndrome are eligible for this study. Parents and~     healthy siblings of patients will also be included for genetic study, and parents of children~     with undiagnosed multiple congenital anomalies syndromes will be included for comparison~     study.~      Participants will provide a blood sample (about 8 to 10 teaspoons from adults; 1 to 3~     teaspoons from children) or sample of skin cells collected by swabbing the inner surface of~     the cheek. Some patients may undergo a skin biopsy, in which a small skin sample (about~     1/8-inch in diameter) is surgically removed. The tissue samples will be used to obtain DNA~     (genetic material) for laboratory testing. A permanent cell line-a collection of cells grown~     in the laboratory from the original tissue specimen-will also be established to enable~     additional testing in the future.~   "
271404|NCT00032864|"~     A Seattle VA study indicated lower extremity ulcers preceded 84% of diabetic amputations.~     Nearly half of the events that ban the causal chain leading to ulcers and amputation were~     initiated by ill-fitting footwear. Other investigators report similar findings for injurious~     footwear in their diabetic patient populations. Yet, the efficacy of footwear in preventing~     ulcers and amputations in the high-risk diabetic population has received limited experimental~     investigation. A British descriptive study followed diabetic patients with healed foot ulcers~     for two years and found reulceration occurred in 72% of patients who resume wearing their own~     footwear compared to 26% of patients who continued wearing prescribed footwear. A Swedish~     cohort study identified individuals with a foot ulcer and reported their 1, 3, and 5 year~     reulceration rates at 34%, 61%, and 70%, respectively, without further specifying footwear~     components. In a German diabetic population the reulceration rate was 87% in-patients who~     abandoned their custom shoes and resumed wearing their own shoes compared to 42% of those who~     continued to wear their custom shoes. Unfortunately, none of these studies compared the~     single or combined contribution of therapeutic shoes or insoles on foot ulcer prevention. Nor~     did these studies address patient adherence to prescribed footwear; thus the actual efficacy~     of various footwear interventions in foot ulcer prevention in this high-risk population is~     still to be tested.~   "
271405|NCT00032838|"~     The purpose of this study is to examine how hormonal changes that occur during stressful~     situations affect thought and emotions. Results from this study may lead to treatments that~     can alleviate the psychological effects of trauma.~      Levels of cortisol and norepinephrine increase in response to stress; these hormones also~     influence thought processes. This study will give hydrocortisone and/or yohimbine (a~     stimulator of central norepinephrine) to healthy adults in order to model the stress response~     and to better understand the way people process information during traumatic events.~      This study comprises two experiments in which the stress response is pharmacologically~     modeled. Participants in the study will have two study visits. During Visit 1, participants~     will undergo a psychiatric assessment, complete neuropsychological tasks, and have their IQ~     measured. During Visit 2, participants will be given hydrocortisone and/or yohimbine. Blood~     will be collected before and during this. Participants will then perform two experiments. In~     one experiment, participants will hear a story with emotional and non-emotional segments; in~     a second experiment, participants will view both emotional and non-emotional stimuli.~   "
271406|NCT00032825|"~     This study will determine the maximum dose of docetaxel that can be given safely in~     combination with ketoconazole for treating advanced prostate cancer. Docetaxel is approved~     for the treatment of several other types of cancers; ketoconazole is an approved antifungal~     medication that is also commonly used in high doses to treat prostate cancer.~      Patients 18 years of age and older with advanced prostate cancer that does not respond to~     hormone therapy may be eligible for this study. Candidates will be screened with blood tests~     to evaluate liver, kidney and other organ function and with x-rays, scans, or other imaging~     tests to determine the extent of disease.~      Participants will take the following medications:~        -  Docetaxel daily, infused through a vein over 30 minutes, in 4-week cycles-3 consecutive~          weeks of drug followed by one week of rest~        -  Dexamethasone, 12 hours and 1 hour before and 12 hours after docetaxel infusions to help~          prevent fluid retention caused by the docetaxel~        -  Ketoconazole, 3 times a day~        -  Hydrocortisone, twice a day to replace a loss of natural steroids caused by the~          ketoconazole~      Patients will be hospitalized 1 to 2 days each for the first and second doses of docetaxel to~     allow for frequent blood draws to measure blood levels of the drug. Ketoconazole will be~     started about 2 weeks after the first dose of docetaxel and the second dose of docetaxel will~     be given 2 days after that. In order to determine the maximum tolerated dose of docetaxel,~     the first few patients in the study will be given a low dose of the drug, and subsequent~     patients will get increasingly higher doses until unacceptable side effects occur. Because~     prostate cancer cells may grow if exposed to testosterone, patients may have to have their~     testosterone production suppressed either surgically (removal of the testicles) or medically~     with an injection of leuprolide or goserelin, which are luteinizing hormone-release hormone~     agonists that reduce the amount of testosterone.~      Imaging studies, such as x-rays, bone scans or computed tomography (CT) scans, will be done~     about every 3 months to examine how the tumor is responding to therapy. After six treatment~     cycles, patients will have monthly chest x-rays to check for fluid around the lining of the~     lungs, which may occur as a result of docetaxel therapy.~      Treatment is expected to continue for at least 3 to 6 months, although this time could be~     shortened or extended depending on the tumor response to therapy or side effects of the~     drugs. Patients who do not experience bad side effects and whose tumor does not grow during~     the first 3 treatment cycles will continue treatment; those who experience unacceptable side~     effects will be taken off the study.~   "
271407|NCT00032799|"~     The purpose of this study is to determine the safety and efficacy of natalizumab in~     individuals diagnosed with moderately to severely active Crohn's disease. It is thought that~     natalizumab may stop the movement of certain cells, known as white blood cells, into bowel~     tissue. These cells are thought to cause damage in the bowel leading to the symptoms of~     Crohn's disease.~   "
271408|NCT00032786|"~     The purpose of this study is to determine the safety and efficacy of natalizumab in~     individuals diagnosed with moderate to severely active Crohn's disease. It is thought that~     natalizumab may stop the movement of certain cells, known as white blood cells, into bowel~     tissue. These cells are thought to cause damage in the bowel leading to the symptoms of~     Crohn's disease.~   "
271409|NCT00032773|"~     To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to~     identify the minimal effective dose of pentostatin defined as the lowest dose that produces a~     response in 20% or more of patients while producing treatment failure (defines as death,~     grade 3/4 toxicity, or progressive disease) in 40% or less of patients.~   "
271410|NCT00032812|"~     This study will examine and compare what happens in the brains of patients with Parkinson's~     disease with that of healthy normal subjects while they train to react as fast as possible to~     the appearance of a visual signal. Particularly, we will measure the amount of the chemical~     dopamine released in the brain as well as the electrical activity during training. Indeed,~     patients with Parkinson's disease frequently complain of slowness and early fatigue during~     movements. These symptoms are believed to be related to a decrease of dopamine in the brain~     which may be associated with abnormalities in cerebral electrical activity.~      Adult patients with Parkinson's disease who are right-handed, do not have dementia, and are~     not depressed may be eligible for this study. Healthy volunteers who match patients in age,~     gender, handedness, and level of education will also be studied. Candidates will be screened~     with a medical history, physical and neurological examinations, memory test, mood evaluation,~     and urine toxicology.~      All participants will be required to stop taking any medications that can influence the~     central nervous system and to abstain from alcohol consumption for 1 week before the~     screening examination and during the study training period. Patients with Parkinson's disease~     will also be required to stop using antiparkinsonian medications for at least 12 hours before~     the first visit and each training session.~      Participants will have several 1-hour training sessions. During these sessions, they will sit~     facing a computer screen at a distance of about 32 inches (80 centimeters) from their eyes.~     Six permanent position markers will be displayed. A keyboard with six spatially compatible~     response keys will be within reach of their right hand. Participants will respond as quickly~     and as accurately as possible to the appearance of a stimulus (e.g., white circle) below one~     of the markers by pressing the spatially corresponding key. About a second later, the next~     stimulus will be displayed below one of the other markers, and so on. Reaction times and~     accuracy will be recorded. After 3 to 10 minutes of practice (one block), there will be a~     rest period during which the computer will display information about the subject's accuracy~     of movements and reaction time. Then, a new block will start. There will be about 6 to 20~     practice blocks per training session. The number of training session will vary between 3 and~     6 depending on accuracy and reaction time during the task.~      During each training session, subjects will have encephalographic (EEG) recordings to measure~     the electrical activity of the brain. In addition, they will have one or two positron~     emission tomography (PET) scans during the first training session, and some will also have~     one or two PET scans during the last session. For the PET scan, the subject will be injected~     with a substance called raclopride, which is taken up by the brain. The raclopride is tagged~     with a radioactive substance so that it can be detected by the PET camera. The amount of~     raclopride detected in the brain will provide an indirect measure of the amount of dopamine~     released during training.~      Before or after one of the training sessions, participants will undergo magnetic resonance~     imaging (MRI) to study brain anatomy. MRI uses a strong magnetic field and radio waves to~     produce images of the brain. The subject lies on a table in a space enclosed by a metal~     cylinder (the scanner). The test takes about 45 to 60 minutes, during which the participant~     must lie very still for 10 to 15 minutes at a time.~   "
271411|NCT00032760|"~     The purpose of this study is to assess the relative effectiveness of a mindfulness~     meditation-based intervention for binge eating disorder in comparison to a psycho-educational~     intervention and a waiting-list control group.~   "
271412|NCT00032747|"~     This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration~     study. Randomization will be stratified according to the patient's baseline serum sodium~     concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next~     level on Day 15, and the total duration of the double-blind treatment period is 120 days.~   "
271413|NCT00032734|"~     The study is designed to assess the efficacy of an investigational drug called SR121463B~     (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood~     associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).~      This double blind period study is followed by 2 open label extension studies with flexible~     doses of satavaptan.~   "
271414|NCT00032721|"~     This study will investigate the use of Reiki, an energy-based complementary and alternative~     medicine (CAM) intervention, as an approach to improve well-being for patients with advanced~     AIDS, and evaluate its effects on dimensions of well-being and quality of life.~   "
271415|NCT00032708|"~     A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously~     vaccinated adults in order to assess the clinical success rates, humoral responses, and~     virus-specific actifity of cytotoxi T cells and interferon-y producing T cells~   "
271416|NCT00032695|"~     The purpose of this study is to determine whether methionine, an amino acid present in low~     doses in the normal diet, can improve myelopathy or stop its progression.~   "
271417|NCT00032682|"~     This study will evaluate a questionnaire for measuring constipation in children with cancer.~     The questionnaire used in this study (Constipation Assessment Scale) reliably predicts the~     presence and severity of constipation in adult patients, but has not been tested in children.~     The answers to the questionnaire will be used to determine the child's level of constipation~     and to plan and provide appropriate care.~      Patients up to 21 years of age who are enrolled in National Cancer Institute trials and are~     taking weekly vinca alkaloids or narcotics twice a day or more may be eligible for this~     study.~      On admission to the study, participants will undergo the following procedures:~        -  The child (or the child's parent) will be interviewed about the child's bowel habits.~        -  The results of the child's most recent physical examination related to bowel function~          will be obtained from the medical record for review.~        -  A registered dietitian will interview the child or parent about the child's eating~          habits.~      During the study, participants will undergo the following procedures:~        -  A registered nurse will interview the child or parent about the child's bowel movements.~          This will be done every other day for hospitalized children and three times a week (by~          phone) for outpatients.~        -  The child or parent will complete a daily diary of bowel movements.~        -  A registered dietitian will evaluate the child's nutritional status periodically (by~          phone).~      Children who are not constipated when they enter the study will receive a stool softener~     every day to prevent constipation. Children who become constipated during the study will be~     treated as needed. Patients will be followed for 7 days after the last dose of vinca alkaloid~     or narcotic for a maximum of 6 weeks.~   "
271418|NCT00032669|"~     This study will evaluate a new treatment strategy called therapeutic drug monitoring (TDM) in~     HIV-infected children and adolescents. TDM involves analyzing the virus, giving drugs the~     virus is most sensitive to, monitoring drug blood levels to make sure there is enough drug to~     work against the virus, and changing the drug dose if it is too low.~      HIV-infected children between 0 and 21 years of age who may benefit from treatment with a~     protease inhibitor and who are not benefiting from their current antiretroviral drug~     treatment regimen may be enrolled in this 48-week study. Patients who are not currently~     receiving antiretroviral treatment, including patients who have never received antiretroviral~     treatment, may be enrolled in the study.~      Participants will have blood drawn to learn what anti-HIV drugs the patient's virus is~     resistant to-that is, what drugs are no longer effective against the virus. This is~     determined by analyzing the virus's genotype (detailed genetic structure) and phenotype~     (response to exposure to anti-viral drugs). Based on these test results and the patient's~     prior medication history, a drug regimen tailored to the individual patient will be~     prescribed. It may include one or two nucleoside reverse transcriptase inhibitors, such as~     zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse~     transcriptase inhibitor such as nevirapine or efavirenz, and a protease inhibitor such as~     amprenavir, nelfinavir, saquinavir, ritonavir, or Kaletra (a combination of lopinavir and~     ritonavir).~      After the patients begin treatment, the amount of the protease inhibitor in the blood will be~     measured. If not enough of the drug is found in the blood, the dose of the drug will be~     increased and the amount of the drug in the blood will be checked again. In this study, the~     dose may be increased up to three times.~      Patients will be seen in clinic for 6 days when treatment begins to measure blood levels of~     the medicines and evaluate the response of the virus. Treatment will then continue on an~     outpatient basis. Drug levels will be measured periodically throughout the study. The viral~     load will also be measured and additional tests to determine whether the resistance pattern~     of the patients' virus has changed. In addition, patients will undergo the following tests~     and procedures at various times throughout the study, more frequently for the first few~     months and then less often:~        -  Blood tests to measure cell counts and viral load~        -  Routine laboratory tests to measure kidney, liver, bone marrow, and other organ~          functioning~        -  Eye and neuropsychologic examinations~        -  Echocardiogram (heart ultrasound)~        -  Electrocardiogram (EKG - heart rhythm test)~        -  Chest X-ray~        -  Computed tomography (CT) scan of the head~        -  Skin tests~      To make sure the medicines work, they must be taken as directed. In addition, since higher~     than usual doses of some of the anti-HIV drugs may be given, it will be important to know~     whether the patients are taking all of the medicine that has been prescribed. This study will~     therefore also measure patients' adherence to their medication regimen in two ways: 1) some~     medicines will be packaged in a bottle with an electronic medicine bottle cap that will~     record when the bottle is opened, and 2) patients and their parents will be interviewed by~     phone or in person at various times during the study about adherence and may be asked to fill~     out forms that record the number of doses taken. This will allow the doctor and patient to~     work together to make sure the medicines are being taken properly. Patients and parents will~     also be interviewed periodically about their understanding of HIV disease, about social~     supports that are available, and about the child's emotional adjustment.~   "
271419|NCT00032656|"~     The purpose of this study is to help improve our understanding of when and why adolescents~     decide to use alternative and complimentary medicines, and to understand factors that lead to~     better communication between youth and their clinicians.~   "
271420|NCT00032643|"~     Congestive heart failure (CHF) affects 4-5 million Americans, and its prevalence is predicted~     to increase over the next few decades. Thyroid hormone has unique actions which make it a~     novel and potentially useful agent for treatment of CHF. Due to possible adverse affects of~     thyroid hormone, there is interest in developing analogs with fewer undesirable side effects.~     3,5- diiodothyropropionic acid (DITPA) has been shown to improve diastolic function in both~     animal models and a recently completed double-blind placebo controlled trial in 19 humans.~      The goal of the proposed Phase II study is to show safety and demonstrate a medication of~     efficacy of DITPA needed in patients with CHF. This study is a prerequisite for a larger~     Phase III trial which would determine whether mortality is improved with DITPA. To better~     define the appropriate doses, prior to the Phase II study we will conduct an initial~     pharmacokinetic study.~   "
271421|NCT00032630|"~     Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover,~     5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in Fiscal~     Year (FY) 1999. Throughout VA and non-VA cardiac surgery programs nationwide, myocardial~     revascularization is now being performed using two surgical techniques. One technique is~     performed with cardiopulmonary bypass (CPB) usually with cardioplegic arrest (on-pump) and~     the other without CPB on a beating heart (off-pump). The overall purpose of this proposed~     randomized, controlled, clinical trial is to rigorously evaluate the impact of using an~     on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG-only)~     procedures (performed with a traditional median sternotomy incision) upon patient clinical~     outcomes and resource utilization.~   "
271422|NCT00032617|"~     The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure~     therapy for treating PTSD and associated problems in female veterans and active duty military~     personnel. We propose to compare exposure therapy, Prolonged Exposure, with a comparison~     therapy that focuses on current problems, Present Centered Therapy.~      The study is a randomized clinical trial involving 384 female veterans and active duty~     personnel in 11 VA medical centers and 1 DoD medical center. All subjects, even~     self-referrals, will enter the study through referrals by mental health clinicians at the~     participating sites. Following informed consent, subjects will be screened for inclusion and~     exclusion diagnoses. If they meet these criteria and agree to participate, they will be~     randomly assigned to one of the two treatments, which will occur weekly for 10 weeks.~     Subjects will be assessed before treatment, immediately following treatment, and 3 and 6~     months after the end of treatment. The primary outcome is PTSD severity. Secondary outcomes~     are anxiety and depression. Exploratory outcomes include associated features of PTSD, such as~     dissociation and substance abuse; psychosocial functioning, quality of life, physical health,~     satisfaction with treatment, and service utilization. Both treatments will be described in~     detail in a treatment manual and monitored intensively to ensure that they are administered~     correctly.~   "
271423|NCT00032591|"~     Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and~     convenience of chronic anticoagulation management, it is likely that there will be demands~     from providers, patients, and manufacturers to make home monitors available to VA patients.~     The rationale for patient self-testing (PST) is that, compared to conventional high quality~     anticoagulation management (HQACM), it would permit more intense monitoring and increased~     patient participation in his/her own care, resulting in increased precision in~     anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The~     secondary hypothesis is that PST and HQACM will be comparable in terms of health care~     utilization and cost.~   "
271424|NCT00032578|"~     This project is a program-wide genetic tissue databank for the Department of Veterans Affairs~     Cooperative Studies Program (CSP). The genetic tissue bank has four components: a central~     repository for DNA and other genetic tissue specimens; a Scientific Advisory Committee of~     individuals with expertise in the genetics and epidemiology of diseases with special~     importance to the VA (including cardiovascular, neurologic, respiratory, psychological and~     other disorders); an Ethics Oversight Committee of individuals with expertise in bioethics~     and the law, as they apply to the collection and use of genetic tissue, and a Coordinating~     Center that administers the tissue bank, coordinates the scientific and ethics oversight~     committees, maintains central access to clinical study data linked to the tissue bank, and~     provides statistical analysis.~   "
271425|NCT00032565|"~     Patients in 'parent' cooperative studies projects are interviewed about their experiences in~     the informed consent process.~   "
271426|NCT00032552|"~     Patients in 'parent' cooperative studies projects are interviewed about their experiences in~     the informed consent process.~   "
271427|NCT00032539|"~     Patients in 'parent' cooperative study projects are interviewed about their experiences in~     the informed consent process.~   "
271428|NCT00032526|"~     Most clinicians who care for patients with inflammatory airway diseases such as allergic~     rhinitis and asthma are aware of the negative effects of certain sights, sounds and smells~     that can precipitate clinical exacerbations in certain susceptible patients. This is thought~     to be due to subconscious associations between these observable stimuli paired and actual~     exposure to allergens that induce clinical symptoms. The severity and duration of these~     symptoms are typically related to levels of anxiety and/or depression in affected patients.~     Classical conditioning of the immune response has been described in many animal and some~     human studies in association with administration of immunosuppressive drugs. In successfully~     conditioned individuals, subsequent exposure to the conditioning stimulus alone produces~     immunosuppressive changes similar to those caused by the drugs themselves. Since disease~     exacerbating conditioning appears to be prevalent in allergic patients, these conditions make~     an excellent human model for understanding the relationships between classical conditioning,~     psychological stress (particularly anxiety and depression) and immune regulation. Thus this~     proposal will seek to examine the hypothesis that antiinflammatory effects of~     pharmacotherapeutic agents can be classically conditioned and are clinically effective due to~     changes in immunoregulatory imbalances known to occur in patients with allergic airway~     diseases. The effectiveness of this therapeutic approach will be significantly affected by~     levels of psychological stress and individual suggestibility. This will be investigated with~     the following Specific Aims: (1). Determine the relative effectiveness of classical~     conditioning by a novel gustatory stimulus paired with immunosuppressive doses of~     corticosteroid on in vivo and in vitro immune responses (allergen - specific vs. general) of~     patients before, during and after classical conditioning correlated with level of clinical~     response; (2) Determine the role of neuroendocrine mechanisms (particularly catecholamines)~     on the inducibility and duration of the conditioned immune responses; and (3) Investigate the~     influence of psychological stress levels (including anxiety and depression) and/or~     suggestibility on baseline immune changes, success and duration of the classical~     conditioning.~      These data will help define parameters for classical conditioning in humans, establish a~     model to investigate mechanisms and serve as the basis for development of future~     interventional protocols for severe inflammatory diseases involving classical conditioning.~   "
271429|NCT00032513|"~     Epstein-Barr virus (EBV) is a member of the human herpes virus family that infects more than~     95 percent of the U.S. population. Most infections occur in childhood and cause no symptoms;~     in adolescents and adults, EBV often causes infectious mononucleosis. It has also been~     associated with certain forms of cancer. Chronic Epstein-Barr virus (CAEBV) is a rare~     disease, primarily of children and young adults, that leads to life-threatening infections.~      This study seeks to identify genetic mutations responsible for CAEBV. A secondary goal is to~     learn more about the natural history of CAEBV.~      The study will examine blood and tissue samples from up to 50 patients (age 2 and above) with~     CAEBV and up to 150 of their relatives (age 2 and above). Autopsy samples may be included in~     the study. Up to 300 anonymous blood samples from the NIH Clinical Center Blood Transfusion~     Medicine will also be examined for comparison.~      No more than 450 milligrams (30 tablespoons) of blood per 8 weeks will be drawn from adult~     patients, and no more than 7 milliliters per kilogram of blood per 8 weeks will be drawn from~     patients under age 18. Local health care providers will refer patients to the study and will~     obtain the samples. Some patients may also be seen at the NIH Clinical Center. Those patients~     will have a full medical history and physical examination, along with chest X-ray, blood~     counts, blood chemistry, EBV serologies, and viral load. Other tests, such as CT scan or MRI,~     may be performed if medically indicated. Patients will be asked to undergo leukapheresis.~      In vitro tests on the blood or tissue samples will include analysis for proteins or genes~     that are involved in the immune response; cloning of portions of patient DNA; transformation~     of B cells with EBV; measurement of the ability of patient blood cells to kill EBV-infected~     cells; determination of lymphocyte subsets; and determination of antibodies to EBV or other~     herpes viruses.~      If a genetic cause for CAEBV is found, the investigators will be available to discuss the~     results with patients in person or by telephone. Genetic indications of risk for other~     diseases will also be discussed with patients.~   "
271430|NCT00032500|"~     The purpose of this study is to determine whether three Echinacea preparations with different~     chemical compositions are effective for prevention or treatment of the common cold.~   "
271482|NCT00031096|"~     Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female~     patients with mild to moderate acne.~      Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks.~     Subjects will be required to return to the doctor's office for up to 5 visits.~   "
273652|NCT00005735|"~     To implement and evaluate a coordinated set of activities for asthma identification,~     education, management, and prevention in the predominantly minority inner city schools in the~     Detroit metropolitan area.~   "
271431|NCT00032487|"~     This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic~     control, achieved through intensification of treatment, is effective in preventing clinical~     macrovascular complications in patients with type 2 DM who are no longer responsive to oral~     agents alone. The study consists of a two-year accrual period and five years of follow-up (7~     years total) of 1700 patients across 20 centers. We have powered the study to detect a 21%~     reduction in the primary event rate. Additional study goals are to determine whether the~     expenditures, discomfort, and adverse effects associated with intensive intervention are~     justified in terms of their clinical benefits, considering both macrovascular and~     microvascular complications.~   "
271432|NCT00032474|"~     The purpose of this study is to examine whether the ingestion of the herbal dietary~     supplement Ginkgo biloba extract has any effect on the efficacy of three classes of diabetic~     medications - (Glucotrol, Glucophage and Actose). Additionally, the study will examine the~     effect of Ginkgo biloba extract on pancreatic insulin production in non-diabetic subjects~     between the ages of 20 and 75 years old.~   "
271433|NCT00032461|"~     Primary Hypothesis: Gulf War veterans will have an equal prevalence or mean level of the~     following medical and psychological conditions frequently reported in the literature compared~     to a control group of nondeployed veterans: (1) chronic fatigue syndrome, (2) fibromyalgia,~     (3) post-traumatic stress disorder, (4) neurologic abnormalities, including peripheral~     neuropathy and cognitive dysfunction, and (5) general health status.~   "
271434|NCT00032448|"~     Inguinal hernia is one of the most common worldwide afflictions of men. The presence of an~     inguinal hernia is indication for its repair. Approximately 700,000 hernia repairs are~     performed in the U.S. each year, and this procedure accounts for 10% of all general surgery~     procedures in the Veterans Health Administration (VHA) (10,000 inguinal herniorrhaphies~     performed per year). There are many different techniques currently in use for repairing~     inguinal hernias and with the advent of laparoscopy, yet another technique is being~     advocated. Laparoscopic repair has been reported in some studies to be superior to open~     repair because of less pain and earlier return to work. However, laparoscopic repair requires~     a general or regional anesthetic and expensive equipment and supplies to perform. There is~     also evidence that open tension-free mesh repair may have results similar to laparoscopic~     repair for these patient centered outcome measures. The general acceptance of this procedure,~     especially in the VHA, has not been uniform. Furthermore, no randomized trial of sufficient~     size and power to be conclusive has been done to set forth the operative gold standard for~     hernia repair.~   "
271435|NCT00032435|"~     The primary objective of this study is to test the hypothesis that administration of folate,~     pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with~     advanced chronic renal failure or end stage renal disease and abnormally high plasma~     homocysteine levels will lower the homocysteine levels and the death rate compared to~     patients who receive placebo. The secondary objective is to test the hypothesis that intake~     of the vitamins compared to placebo decreases the incidence of myocardial infarction,~     disabling stroke, and amputation of a lower extremity and, in hemodialysis patients,~     thrombosis of the vascular access.~   "
271436|NCT00032422|"~     The purpose of this study is to determine if acupuncture decreases adrenaline levels in heart~     failure, thereby potentially improving survival and quality of life.~   "
271437|NCT00032409|"~     The purpose of this study is to determine the effects of music therapy-based relaxation~     stress/reduction strategies on the frequency/severity of toxic side-effects of marrow~     ablative chemotherapy and the timing of immune reconstitution in patients undergoing bone~     marrow/stem cell transplantation.~   "
271438|NCT00032396|"~     A study evaluating Retisert in patients with age-related macular degeneration~   "
271439|NCT00032383|"~     The purpose of this study is to determine the relative merits of vestibular rehabilitation~     and Tai Chi for patients with inner ear (vestibular) disorders.~   "
271440|NCT00032370|"~     Although a number of sophisticated diagnostic tests have been shown to be helpful in~     identifying patients at high risk for perioperative cardiac complications, no study has~     addressed the most important question: Should prophylactic coronary revascularization be~     performed prior to elective vascular surgery? This study is designed to answer this question.~   "
271441|NCT00032357|"~     Veterans Affairs Cooperative Study #410, The Iron and Atherosclerosis Trial, FeAST, a~     24-hospital prospective randomized single-blinded clinical trial of graded iron reduction was~     conducted between May 1, 1999 and April 30, 2005, and has now been completed. A total of~     1,277 primarily male participants with peripheral arterial disease were entered. The primary~     outcome was all cause mortality and the secondary outcome combined death plus non-fatal~     myocardial infarction (MI) and stroke.~   "
271442|NCT00032344|"~     Colorectal cancer is a leading cause of cancer death in the United States. Mortality remains~     high because most colorectal cancers are detected after there has been regional or distant~     spread, precluding curative surgical resection. With this in mind, screening strategies have~     been recommended for asymptomatic individuals which hope to reduce mortality from colon~     cancer by detecting and removing premalignant adenomatous polyps or early malignant lesions.~     Screening of asymptomatic individuals over age 50 with sigmoidoscopy and fecal occult blood~     tests has been advocated by the American Cancer Society. However, current screening will~     identify only 50% of patients who have adenomatous polyps. More sensitive tests for polyp~     detection, like colonoscopy, are costly, require extensive resources and are unlikely to be~     used for screening large populations. Ideal screening would identify patients with the~     highest risk of cancer and target more sensitive screening tests at this population. The~     identification of low cost, easily collectible risk factors which can be used to target~     patients for the more sensitive screening tests is the primary purpose of this study. Since a~     major segment of the veteran population is over the age of 50, there will be a substantial~     impact in reduction of both mortality and morbidity due to colon cancer and attendant cost~     savings to the VA for treatment if such risk factors can be identified.~      Phase I is a cross-sectional study designed to identify risk factors for large (>1 cm)~     adenomatous polyps. Approximately 3200 asymptomatic subjects (age 50-75) have completed risk~     factor assessment, medical and dietary histories, and have undergone complete colonoscopy~     examination. This will identify for comparison purposes a polyp-free control group and is the~     first large prospective study to include such a group. Data at colonoscopy will characterize~     the prevalence, size and distribution of adenomatous polyps. This will permit an assessment~     of sensitivity of sigmoidoscopy in this population. In addition, tissue from normal rectal~     mucosa will be analyzed for evidence of cell proliferation activity. The primary focus of~     Phase I is a risk factor analysis. A multivariate analysis will be performed to determine the~     relationship of historical and environmental factors as well as cell proliferation activity~     with the presence of adenomatous polyps. A cohort consisting of a subgroup of polyp patients~     (large and small) and matched polyp-free controls will be tracked longitudinally to determine~     polyp occurrence/recurrence rates.~      Phase II of the study is a long-term follow-up study designed to evaluate the relative risk~     of two repeat colonoscopies.~      Phase III is an extension in follow-up of an additional five years, a total of ten years in~     all, to include all study patients. The primary focus will be on documenting long-term~     mortality and medical outcomes as well as occurrence/reoccurrence of neoplasia with special~     emphasis on ten-year cancer rates.~   "
273653|NCT00005734|"~     To implement and evaluate a comprehensive asthma education and prevention program in all 54~     public elementary schools in the predominantly minority Birmingham, Alabama school system.~   "
271443|NCT00032331|"~     All patients with a new, untreated solitary pulmonary nodule (SPN) between 7 mm and 3 cm in~     diameter identified by chest x-ray, will be approached to undergo positron emission~     tomography (PET) and computerized tomography (CT). The PET and CT scans will be interpreted~     independently.~      The Primary Care Physician will be provided the results of the baseline chest x-ray and the~     CT scan, and will be asked for a management and treatment decision. Then the results of the~     PET will be provided to the Primary Care Physician who will be asked for a management and~     treatment decision based on all findings (chest x-ray, CT, and PET).~   "
271444|NCT00032305|"~     The purpose of the study is to evaluate an intravenous (by injection) investigational~     medication to treat severe ulcerative colitis refractory to steroid therapy. The research is~     being conducted at up to 8 clinical research sites in the US and is open to both men and~     women ages 18 to 70 years old. Participants in the study will have a number of visits to a~     research site. All study-related care and medication is provided to qualified participants at~     no cost: this includes all visits, examinations and laboratory work.~   "
271445|NCT00032292|"~     The purpose of this Phase I/II, open-label, dose-escalation study is to evaluate an~     investigational monoclonal antibody administered as a first-line therapy to patients with~     acute, Grade II, III, or IV graft-versus-host disease (GVHD). Patients will be eligible for~     enrollment within 24 hours of beginning standard steroid treatment. The research is being~     conducted at up to 10 clinical research sites in the US.~   "
271446|NCT00032279|"~     The purpose of this phase II study is to evaluate an investigational monoclonal antibody for~     the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients~     diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment~     with standard agents will be considered for entry. Patients will be allowed to continue on~     their other immunosuppressive drugs at stable doses during the trial. The research is being~     conducted at up to 20 clinical research sites in the US.~   "
271447|NCT00032240|"~     This trial will test shoe inserts for the treatment of knee osteoarthritis, the most common~     form of knee arthritis. Those with disease on the inner (medial) aspect of the knee will be~     studied.~   "
271448|NCT00032227|"~     The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the~     Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a~     randomized trial comparing surgical and nonsurgical treatments for patients with early, mild~     to moderate carpal tunnel syndrome. In addition the study will evaluate the ability of a new~     magnetic resonance (MR) technique at predicting who will likely benefit from carpal tunnel~     syndrome (CTS) surgery.~   "
271449|NCT00032201|"~     Background:~        -  Many risk factors for breast cancer have been identified, including family history,~          endocrine background, changes in breast tissue, cancer in one breast, radiation~          exposure, obesity and others. There is a spectrum of tissue changes seen in cancerous~          and pre-cancerous breast tissue.~        -  A cell line is a collection of cells that are grown in the laboratory from an original~          tissue specimen. Cell lines developed from high-risk breast tissue allow researchers to~          perform metabolic and molecular studies of breast cells over time.~      Objective: To establish a repository (facility in which tissue samples can be preserved and~     stored for many years) of cell lines from high-risk breast tissue to allow researchers to~     learn more about changes in breast cells that may cause them to develop into breast cancer.~      Eligibility: Women between 20 and 80 years of age who:~        -  Have an increased risk of breast cancer because they are members of a high-risk breast~          or ovarian cancer family.~        -  Have had breast cancer in one or both breasts.~        -  Have had radiation for lymphoma before the age of 30.~        -  Have a mutation in a breast cancer susceptibility gene, but whose family history is not~          known.~        -  Are not at increased risk of breast cancer.~      Design:~        -  A small piece of breast tissue will be obtained from about 10 women without an~          identified risk of breast cancer and up to 100 women at high risk of developing breast~          cancer.~        -  Cell lines will be developed from each high-risk category.~        -  The cell lines and tissues will be used to establish a repository of high-risk breast~          cell lines and breast tissues that can be used to study how the cells develop into~          breast cancer.~   "
271450|NCT00031551|"~     This study consisted of two parts: the pilot study and the main study. The purpose of the~     pilot study is to demonstrate the effectiveness of planned laboratory techniques to assess~     for TNF-alpha gene expression from unstimulated saliva, plasma, and mucosal epithelial cells~     in patients who have chemotherapy-related stomatitis.~      Main Study Description: Stomatitis is defined as inflammation of the mucous membranes of the~     oral cavity and oropharynx characterized by tissue erythema, edema, and atrophy, often~     progressing to ulceration. Stomatitis is a biologically complex, multifactorial, cancer~     treatment-related oral condition experienced by many oncology patients, which often leads to~     a cascade of negative sequelae including oropharyngeal pain, critical treatment alterations~     or cessation, and decreased quality of life. The optimal treatment strategies for stomatitis~     have not been established. There is a critical need to examine the pathogenesis of and to~     evaluate interventions for stomatitis and related acute oropharyngeal pain in the randomized~     controlled clinical trial setting using valid and reliable stomatitis assessment tools to~     both advance the science of cancer treatment-related oral toxicities and improve patient~     care. Therefore, the purpose of this randomized controlled clinical trial is to elucidate the~     role of inflammation in stomatitis by testing the effects of a novel tumor necrosis factor~     (TNF) fusion protein etanercept, (Enbrel, Immunex Corporation, Seattle, WA) on the incidence~     and severity of stomatitis. The actions of this fusion protein, which binds specifically to~     TNF preventing its interaction with cellular receptors and altering the inflammatory cascade,~     may provide insight into the role of inflammation in stomatitis. An etanercept effect is~     defined as a prevention or amelioration of stomatitis and acute oropharyngeal pain and/or~     changes in levels of tissue mediators. If stomatitis is primarily a consequence of a mucosal~     inflammatory response, then we hypothesize that this oral condition will be responsive to~     binding of TNF(alpha). Elaboration of the role of inflammatory cell signaling associated with~     stomatitis and the effect of TNF(alpha) may elucidate the mechanisms related to the~     pathogenesis of stomatitis and to other mucosal conditions.~      Patients who are scheduled to receive autologous or allogenic peripheral blood stem cell or~     bone marrow transplant will be invited to participate in this study during a regularly~     scheduled pre-treatment visit. Written informed consent will be obtained from all~     participants. Patients will be randomized to receive either etanercept mouthwash or placebo,~     which will both be administered by protocol schedule. Stomatitis and oropharyngeal pain will~     be measured at baseline and at specified post-chemotherapy time points corresponding with the~     predicted stomatitis onset, peak, and healing time course. TNF(alpha) levels in buccal~     mucosa, analyzed by reverse transcriptase polymerase chain reaction techniques, and blood~     levels of pro-inflammatory cytokines, growth factors, and inflammatory mediators will also be~     measured at baseline and at specified post-chemotherapy time points corresponding with the~     predicted stomatitis onset, peak, and healing time course.~   "
271483|NCT00031083|"~     In this study an investigational replication-defective, recombinant adenovirus expressing the~     interferon-beta gene (BG00001) will be directly injected into tumors, in patients with~     recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. The purpose~     of the study is to evaluate the safety and any harmful effects of injection of BG00001 into~     brain tumors. Also, this study will help determine whether the virus carrying the beta~     interferon gene will enter brain tumor cells and cause the cancer cells to die. This study~     will require one hospital admission for the actual procedure of drug administration. All~     other visits will be conducted on an out-patient basis~   "
271451|NCT00031538|"~     This study will analyze tissue and blood samples from patients with gliomas (a type of brain~     tumor) to develop a new classification system for these tumors. Tumor classification can help~     guide treatment, in part by predicting how aggressive a tumor may be. Gliomas are currently~     classified according to their grade (how quickly they may grow) and the type of cells they~     are composed of. This system, however, is not always accurate, and sometimes two tumors that~     appear to be identical under the microscope will have very different growth patterns and~     responses to treatment. The new classification system is based on tumor genes and proteins,~     and may be used in the future to better predict a given tumor s behavior and response to~     therapy.~      Patients with evidence of a primary brain tumor and patients with a known glioma who will be~     undergoing surgery to remove the tumor may participate in this study.~      A sample of tumor tissue removed in the course of a participant s normal clinical care will~     be used in this study for laboratory analysis of genes and chromosome abnormalities. A small~     blood sample will also be collected for genetic analysis. In addition, clinical information~     on patients condition and response to treatment will be collected every 6 months over several~     years. This information will include findings from physical and neurologic examinations,~     radiographic findings, and response to therapy, including surgery, radiation and~     chemotherapy.~   "
271452|NCT00031512|"~     A common group of viruses that infect humans are enteroviruses. Enteroviruses produce~     illnesses in children which may range from very mild (summer colds) to severe (infections of~     the brain, liver, and heart). The purpose of this study is to determine if a new drug called~     pleconaril helps treat babies with enteroviral sepsis. In addition, researchers are~     attempting to determine a safe and effective dose of pleconaril to help babies with this~     disease. Infants who are 15 days or younger when diagnosed with enteroviral disease are~     eligible for this study. Two out of 3 babies will be randomly assigned to receive Pleconaril~     and the other one out of three will receive a placebo (inactive substitute). Participants~     will be hospitalized while receiving study medication. Babies will receive standard treatment~     care for their symptoms and will be observed for their medical progress. Participants may be~     in the study for up to 2 years.~   "
271453|NCT00031499|"~     The purpose of this study is to determine if azithromycin, a drug approved for treatment of~     other infections, is as effective for syphilis (a sexually transmitted disease) as the~     standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55~     years of age, with primary, secondary or early latent syphilis, will participate in this~     research study. Volunteers will be enrolled in 5 U.S. cities and in Madagascar. Participants~     will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin~     given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history~     of a penicillin allergy will be given either 2.0 g of oral azithromycin or 100 mg doxycycline~     taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures~     will include blood samples, physical exams, and swabs of sores.~   "
271454|NCT00031486|"~     This study involves patients 12 years and older who have been diagnosed with herpes simplex~     encephalitis (HSE) by a specific laboratory test and have completed treatment or are being~     treated with intravenous (given through a needle inserted into a vein) acyclovir. The purpose~     of the study is to determine if treatment with 4 tablets, 500 milligrams each, of~     valacyclovir given 3 times daily by mouth for 90 days is both effective and safe after~     completing intravenous acyclovir treatment and if it can increase survival with or without~     mild impairment of the brain and mental functions. Participants will be assigned to either~     drug or placebo (inactive substance) randomly (by chance). Study procedures will include~     blood samples and lumbar punctures (procedure in which a needle is inserted into the lower~     back to collect cerebral spinal fluid). Subjects will participate for up to 24 months.~   "
271455|NCT00031473|"~     The purpose of this study is to test the safety and effectiveness of ribavirin, administered~     as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV~     pneumonia in bone marrow and peripheral blood transplant recipients.~   "
271456|NCT00031460|"~     The purpose of this study is to test whether long term treatment with acyclovir given orally~     (by mouth) improves the outcome for infants with herpes simplex virus infection of the brain~     or spinal cord (known as the central nervous system [CNS]). Infants with herpes viral~     infection of the CNS that has or has not spread to other parts of the body will be enrolled~     in this study. All participants will receive treatment in a hospital for 21 days with~     acyclovir, given intravenously (by a needle inserted into a vein). Participants will then be~     divided into two groups: those with CNS disease that has or has not spread to the skin, and~     those whose viral infection has spread and involves the CNS. Both groups will be randomly~     assigned to receive either oral acyclovir or placebo (inactive substance) for 6 months.~     Infants in the US and Canada will participate for 5 years. A physical exam, hearing exam, eye~     exam, and an evaluation of the nervous system will be performed throughout the study.~   "
271457|NCT00031447|"~     The purpose of this study is to test whether long-term treatment with oral acyclovir improves~     the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes, and mouth~     (SEM). Study participants will include infants in the United States and Canada who have HSV~     disease of the skin, eyes, and mouth, with no central nervous system disease present.~     Initially, all subjects will be treated with acyclovir administered through IV access~     (through the vein) for 14 days while hospitalized. Participants will then be placed in one of~     two groups, acyclovir given by mouth or a placebo (substance with no medication present). The~     participant and the study site will not know to which group the subject is assigned. All~     children will be followed at 6, 12, 24, 36, 48, and 60 months of age. During the follow up~     visits, physicals, hearing assessments, eye assessments, and neurological assessments will be~     completed.~   "
271458|NCT00031434|"~     The purpose of this study is to evaluate how ganciclovir is metabolized when administered~     intravenously (by a needle inserted into a vein) following valganciclovir syrup, given by~     mouth to newborns and young infants with symptoms of congenital (present at birth)~     cytomegalovirus (CMV) disease. The study also seeks to identify a dose of valganciclovir that~     provides a comparable blood concentration to ganciclovir present in the blood of newborns~     with symptomatic congenital CMV disease. All study participants will receive 6 weeks of~     antiviral therapy (defined as ganciclovir and/or valganciclovir). Infants from 0 to 30 days~     old will participate in the study for 2 years.~   "
273654|NCT00005733|"~     To develop and implement asthma controlling strategies for inner city and high risk~     populations.~   "
271459|NCT00031421|"~     The purpose of this study is to document the developments associated with puberty and~     determine if any of the children who previously participated in another research study have~     been diagnosed with cancer. The previous study was a Collaborative Antiviral Study Group~     (CASG) protocol entitled Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic~     Congenital Cytomegalovirus Infections. One of the medications used in this study to treat~     cytomegalovirus (CMV), ganciclovir, has been known to cause cancer and affect the development~     of gonads (ovaries in females and testes in males) when administered to animals. Children,~     9-14 years old, who participated in the previous research study, will participate in this~     study for 1 day. Subjects will be evaluated by an endocrinologist and will have the following~     procedures performed: a complete physical examination, a single blood sample collected, an~     x-ray of the left wrist.~   "
271460|NCT00031408|"~     The purpose of this study is to obtain informed consent to use stored human biological~     materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic~     testing.~   "
271461|NCT00031395|"~     The purpose of this study is to determine the safety and efficacy of clonidine alone or in~     combination with methylphenidate for children 7-12 years of age with attention-deficit,~     hyperactivity disorder.~   "
271462|NCT00031382|"~     This study uses magnetic resonance imaging (MRI) to explore the brain activities involved in~     performing learned automatic movements. Automatic movements are performed without~     concentrating on the details of the movement.~      Healthy adult volunteers are eligible for this study. Candidates will have a medical history~     and brief physical examination and will fill out a questionnaire. Women of childbearing~     potential will have a urine pregnancy test. Pregnant women will not be enrolled.~      Participants will perform certain tasks involving movement of the right or left hand while~     undergoing MRI scanning. They will undergo scanning twice-before and after practicing the~     movement tasks. Before the second scan, participants will practice the following tasks for 1~     week:~        -  Tapping task - subjects use their left index finger to tap a button at a certain~          frequency.~        -  Sequential movement task - subjects perform sequential finger-tapping movements with~          their right hand, in which they tap buttons with their fingers at a certain frequency in~          a 25-second period. There are two sequences of different lengths, referred to as~          sequence-4 and sequence-12, based on the number of movements in each unit of the~          sequence.~        -  Visual distraction task - 14-letter sequences consisting of the letters A, G, L, and O~          will be presented and subjects will be asked to identify the number of times they see a~          target letter.~        -  Dual tasks - after completing all the above tasks, subjects perform the following dual~          tasks:~      Tapping and visual task~      Sequence-4 finger tap and visual task~      Sequence-12 finger tap and visual task~      Tapping and sequence-4 finger tap~      Tapping and sequence-12 finger tap~      When the participants can perform the dual tasks correctly 90 percent of the time, the~     movements will be considered automatic, and the subjects will undergo MRI scanning. MRI uses~     a magnetic field and radio waves to produce images of the brain. For the procedure, the~     subject lies still on a stretcher that is moved into the scanner (a narrow cylinder~     containing the magnet). Earplugs are worn to muffle loud noises caused by electrical~     switching of radio frequency circuits used in the scanning process. The scan will last about~     1.5 hours.~   "
271463|NCT00031369|"~     This study will use high-resolution magnetic resonance imaging (MRI) to look for subtle~     differences in brain anatomy between patients with focal hand dystonia (also called writer s~     cramp) and healthy normal volunteers. Patients with hand dystonia have prolonged muscle~     contractions that cause sustained twisting movements and abnormal postures. These abnormal~     movements often occur with activities such as writing, typing, playing certain musical~     instruments such as guitar or piano, or playing golf or darts.~      Patients with focal hand dystonia and healthy volunteers will be enrolled in this study.~     Patients will be recruited from NINDS s database of patients with focal hand dystonia.~     Volunteers will be selected to match the patients in age, sex and handedness.~      This study involves two visits to the NIH Clinical Center. The first visit is a screening~     visit, in which patients and volunteers will have a medical history, physical examination,~     neurological examination, and assessment of handedness. Women of childbearing age will be~     screened with a pregnancy test. Pregnant women are exclude from this study.~      Those who join the study will return for a second visit for magnetic resonance imaging. MRI~     uses a magnetic field and radio waves to produce images of the brain. For the procedure, the~     participant lies still on a stretcher that is moved into the scanner (a narrow cylinder~     containing the magnet). Earplugs are worn to muffle loud noises caused by electrical~     switching of radio frequency circuits used in the scanning process. The scan will last about~     45 to 60 minutes, at most. Some volunteers may be asked to return for a third visit to obtain~     a second MRI on a different scanner.~   "
271464|NCT00031343|"~     This study will evaluate how controlling HIV infection with HAART (highly active~     antiretroviral therapy) affects the response to hepatitis C treatment with peginterferon~     alpha-2b and ribavirin in HIV-infected patients with chronic hepatitis C. HIV worsens liver~     disease caused by hepatitis C. Since treatment of HIV infection with HAART improves immune~     function, it may be beneficial to start HAART before treating HCV.~      HIV-infected patients 18 years of age and older with chronic hepatitis C infection may be~     eligible for this study. Patients must have an HCV viral load greater than 2000 copies/mL and~     a CD4 count that is either more than 500 cells/mm3, or more than 350 cells/mm3 with an HIV~     viral load no greater than 40,000 particles/mL. Candidates will be screened for current or~     previous diseases, conditions or treatments that may exclude them from this study. Screening~     includes a medical history and physical examination, eye examination, blood and urine tests,~     chest X-ray, electrocardiogram (EKG), liver ultrasound, and, possibly, a liver biopsy, if a~     recent one is not available. The liver biopsy is optional and is done to determine the~     severity of liver disease. Patients will be sedated for this test. The skin in the area over~     the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and~     out of the liver to obtain a small tissue sample. Patients remain in the hospital overnight~     for monitoring. Women of childbearing age will have a pregnancy test.~      Patients enrolled in the study will be randomly assigned to one of the following treatment~     groups: 1) pegylated interferon and ribavirin for 48 weeks (control group); or 2) HAART for 6~     months, followed by 48 weeks of pegylated interferon and ribavirin.~      HAART group - Patients taking HAART will be followed in the clinic every 2 weeks for the~     first month and then monthly for the next 5 months. After 6 months of HAART they will begin~     taking pegylated interferon and ribavirin and will follow the dosing and follow-up schedule~     outlined below for patients in the control group.~      Control group - Patients will have weekly injections under the skin of peginterferon alpha-2b~     and ribavirin pills daily by mouth. Clinic visits will be scheduled as follows:~        -  Days 1, 3, 7, and 21 - Blood will be drawn for safety tests and to measure blood levels~          of HIV and HCV. HCV medications will be injected on days 7 and 21.~        -  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56, and 64 - Blood and urine~          tests will be done to determine the side effects of pegylated interferon and ribavirin~          treatment and its effect on the HCV infection. Eye examinations will be done every 3~          months.~        -  Week 48 or end of treatment - Treatment with pegylated interferon and ribavirin will~          stop after 48 weeks. At this time (or earlier for those who do not complete the 48 weeks~          of treatment), patients will return to the clinic for a routine visit, blood tests~          (including a test for hepatitis B) and abdominal ultrasound. Patients may also be~          hospitalized for 2 days for a repeat optional liver biopsy.~        -  Week 72 and extended follow-up visits - At week 72, patients will return for blood tests~          and a routine clinic visit. HCV viral load will be measured. Follow-up visits every 3~          months for an additional year will include a blood test to measure HCV viral load and a~          complete physical examination.~   "
271465|NCT00031317|"~     The purpose of this study is to examine the safety and effectiveness of the drug combination~     paroxetine and clonazepam in treating people with panic disorder (PD) and major depression.~      The main goal in treating people with PD is to rapidly reduce symptom severity and improve~     functioning. While numerous drug therapies have been used to treat PD, these treatments are~     limited by variable response rates and suboptimal side effect profiles. Evidence suggests~     that clonazepam given with a selective serotonin reuptake inhibitor (SSRI) can facilitate a~     rapid reduction in PD symptoms. However, it is unclear whether comorbid depression influences~     treatment response to the clonazepam and SSRI regimen. This study will examine whether~     combined treatment with clonazepam and the SSRI paroxetine will accelerate clinical response~     in participants with PD and comorbid depression. This study will also examine whether the~     benefits of treatment will be sustained until the end of the study despite tapering of~     clonazepam at the midpoint of the study.~      Participants in this study will be screened with medical and psychiatric interviews, a~     physical examination, electrocardiogram (ECG), and blood tests. Participants will then be~     randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus placebo (an~     inactive pill) for 12 weeks. Participants will have weekly clinic visits during which~     symptoms and drug side effects will be checked and an interview to evaluate panic disorder~     and depression symptoms will be conducted.~   "
271466|NCT00031304|"~     Healthy volunteers will be screened under this protocol for possible participation in a study~     testing a vaccine against HIV, the virus that causes AIDS.~      Healthy adults 18 to 60 years of age may be eligible for this study. Participants must be in~     good general health with no history of significant medical problems or abnormal laboratory~     test results. Pregnant or breast-feeding women and people infected with HIV will not be~     enrolled.~      Participants enrolled in this protocol will undergo the following tests and procedures within~     8 weeks before the start of the experimental vaccine study:~        -  Medical history, including history of sexual activity and drug use~        -  Physical examination~        -  Pregnancy test for women of childbearing age~        -  Blood and urine tests to evaluate possible medical problems such as liver and kidney~          function; to evaluate immune function; and to test for HIV, hepatitis and syphilis~      Individuals who are identified through this screening protocol as possible candidates for an~     HIV vaccine trial will be provided additional information about study options.~   "
273655|NCT00005732|"~     To develop and implement asthma controlling strategies for inner city and high risk~     populations.~   "
271467|NCT00031291|"~     This protocol is a joint project of the National Institutes of Health, the Centers for~     Disease Control and the United States Army Medical Research Institute for Infectious~     Diseases. It is designed to collect plasma from healthy employees of the Department of~     Defense who have been vaccinated against anthrax. The collected plasma will be pooled to make~     an anthrax-fighting antibody solution called anthrax immune globulin intravenous (AIGIV).~     This solution will be used for:~        -  Animal experiments to test its effectiveness in preventing the development of anthrax~          after inhalation exposure;~        -  Treating people severely ill with anthrax who are not improving with standard antibiotic~          therapy; and~        -  Treating people exposed to spores of the bacteria that cause anthrax to try to prevent~          development of the disease.~      Healthy volunteers between 18 and 65 years of age who have received at least four doses of~     the anthrax vaccine and who meet the criteria for blood donors may be eligible to participate~     in this study. Volunteers will be recruited from Department of Defense civilian and military~     employees. Candidates will be screened with an interview and blood tests.~      Participants will undergo the following procedures:~        -  Have a health history screen for donating plasma~        -  Measurement of heart rate, blood pressure and temperature~        -  Fingerstick to check hemoglobin level~        -  Blood tests for HIV, hepatitis B and C, syphilis and other infectious diseases~        -  Blood test for anthrax antibody levels~        -  Plasmapheresis to collect blood plasma (the liquid part of the blood)~      In plasmapheresis, whole blood is drawn through a needle placed in an arm vein. The blood~     flows into a cell separator machine, where it is spun to separate the plasma from the blood~     cells. The plasma is collected in a plastic bag in the machine, while the rest of the blood~     is returned to the donor through the needle in the arm. During the procedure, the donor is~     given a blood thinner called citrate to prevent the blood from clotting while it is in the~     cell separator machine. The procedure lasts from 60 to 90 minutes. Only a small fraction of~     the body's total plasma is removed, and it is quickly replaced by the body with no long-term~     health effects. Participants may be requested to donate plasma as often as every 3 to 4 days~     or as infrequently as once a month for a maximum of six donations.~   "
271468|NCT00031278|"~     The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is~     safe and effective in the treatment of metastatic breast cancer.~      RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may~     potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety~     and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with~     metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.~      SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.~   "
271469|NCT00031265|"~     The purpose of this trial is to determine if a family intervention administered by telephone~     to stroke patients and their caregivers increases adaptation and functioning after stroke.~   "
271470|NCT00031252|"~     To test the independent and interrelated effects of the neighborhood social environment, the~     neighborhood physical environment, and individual risk factors in predicting all-cause and~     cardiovascular disease mortality.~   "
271471|NCT00031239|"~     To assess the effects of weight loss on sleep disordered breathing in obese, Type 2 diabetics~     with obstructive sleep apnea.~   "
271472|NCT00031226|"~     To determine how weight loss achieved by intensive lifestyle intervention including diet and~     exercise alters lipoprotein oxidation/oxidative stress and antioxidant status in overweight~     diabetic individuals.~   "
271473|NCT00031213|"~     To evaluate the relationship of baseline toenail chromium concentrations to weight loss, as~     well as the interaction between heavy metals and the beneficial effects of weight loss.~   "
271474|NCT00031200|"~     To investigate the composition and nature of weight loss and weight maintenance during the~     Look AHEAD trial. Also, to model changes in resting energy expenditure and changes in cardiac~     structure and function associated with weight loss.~   "
271475|NCT00031187|"~     SGN-15 is being investigated for therapy of patients with prostate cancer in combination with~     the cytotoxic agent, Taxotere. The study is an open label, randomized phase II study for~     patients with documented hormone refractory prostate cancer who have not had any prior~     therapy with Taxotere or Novantrone. Both SGN-15 and Taxotere will be administered weekly~     over two 6 week courses separated by a 2 week rest period.~   "
271476|NCT00031174|"~     This study will collect white blood cells or plasma (the liquid part of the blood), or both,~     from healthy volunteers and from patients with rheumatic or kidney disorders for research~     purposes. Rheumatic disorders involve abnormalities of the immune system, the body s defense~     against disease. The immune system consists of white blood cells such as lymphocytes and~     monocytes, which produce substances such as antibodies and cytokines. White cells and plasma~     will be collected through a procedure called apheresis (described below).~      Healthy volunteers and patients with confirmed or suspected rheumatic or kidney disease who~     are 18 years of age or older may be eligible for this study. Patients must be participating~     in a current protocol of the National Institute of Arthritis and Musculoskeletal and Skin~     Diseases or the National Institute of Digestive, Diabetes and Kidney Diseases. All candidates~     will be screened with a history, physical examination, and blood tests for hepatitis B and C~     and HIV infection. Women of childbearing age will be tested for pregnancy. Routine blood~     tests will be done in all volunteers, and in patients where needed. Pregnant women and people~     who test positive for hepatitis or HIV may not participate.~      Participants will undergo apheresis to collect lymphocytes, monocytes, or plasma from the~     blood. For this procedure, a needle is placed in a vein in the arm. Blood flows from the vein~     through a tube (catheter) into a machine that spins the blood, separating it into its~     components. The required cells or plasma are extracted, and the rest of the blood, including~     the red cells and platelets, is returned to the body through the same needle or through a~     second needle placed in the other arm.~      Cells collected from volunteers will be used in studies comparing the number and function of~     similar cells from patients with rheumatic diseases, focusing on the differences in number~     and function of the cells in health and disease. Components collected from patients will be~     used only for studies described in the protocol in which they are currently enrolled.~   "
271477|NCT00031161|"~     This is a study to determine the safety of dichloroacetate (DCA) with a low-tyrosine diet~     given with or without nitisinone (NTBC) in children with chronic lactic acidosis (CLA).~   "
271478|NCT00031148|"~     This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to~     prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow~     (BM) or peripheral blood progenitor cell (PBPC) transplantation.~   "
271479|NCT00031135|"~     This is a study to determine whether choline, when added to total parenteral nutrition (TPN),~     can help prevent the development of hepatic steatosis, a liver disease, in patients on TPN.~   "
271480|NCT00031122|"~     The purpose of this study is to describe the genetic contribution to the neural tube defects~     spina bifida (SB) and anencephaly (A), which includes identifying patients, defining the~     roles of certain genes, and studying gene-environment interactions.~   "
271481|NCT00031109|"~     The purpose of this study is to see if an investigational vaccine can make antibodies~     (proteins found in blood) in humans that will influence the course of an AIDS-like disease in~     monkeys. Hopefully, the results of this study can be applied to humans.~      AIDS, which is caused by infection with HIV, is associated with many deaths and occurrences~     of disease. Although recent advances have been made in anti-HIV therapy for AIDS, there is no~     cure for HIV infection or AIDS, and drug therapy is too expensive for most infected~     populations. Some organizations are trying to make safe and effective vaccines that may~     prevent HIV infection and AIDS worldwide. Certain vaccines can generate specific antibodies~     in humans, but they do not inhibit HIV infection in laboratory tests. It is possible,~     however, that these antibodies may make HIV disease less severe following infection. For this~     reason, monkeys will be used to evaluate the role of specific human antibodies.~   "
271484|NCT00031070|"~     The purpose of this study is to see if cyclosporine, taken when a patient begins highly~     active antiretroviral therapy (HAART), increases the number of CD4 T-cells (blood cells that~     fight infection) in a patient's blood. This study also will explore the safety of briefly~     giving cyclosporine to patients starting HAART.~   "
271485|NCT00031057|"~     The purpose of this study is to see if vitamin B can treat mild hyperlactatemia (a higher~     than normal level of lactate in the blood) in patients who take nucleoside reverse~     transcriptase inhibitors (NRTIs).~      Hyperlactatemia is a potentially life-threatening condition that can be associated with NRTI~     therapy. A lack of vitamin B may be related to the development of hyperlactatemia. However,~     no studies have been done to evaluate this. This study proposes that high doses of vitamin B~     may bring elevated lactate levels back to normal among patients taking NRTIs.~   "
271486|NCT00031044|"~     Even though powerful anti-HIV drug combinations have been successful in patients with little~     or no prior anti-HIV therapy, studies have shown that these treatments are less effective in~     patients who have been treated with nucleoside analogues. This study will test the safety and~     effectiveness of adding one or two new drugs to a personalized anti-HIV regimen for patients~     whose previous HIV treatments have failed.~   "
271487|NCT00031031|"~     The Kanglaite Injection (KLT)is a novel broad spectrum anti-cancer injection produced from~     traditional Chinese medicinal herbs (the Coix Seed). It was approved in China in 1995 and has~     become the most popular anti-cancer drug in China. In June of 2001, the Phase I study of KLT~     commenced at the Huntsman Cancer Institute in Salt Lake City, Utah, with the objectives of 1)~     To determine the maximum tolerated dose (MTD) and the safety profile of KLT in patients with~     refractory solid tumors; 2) To determine the pharmacokinetics of KLT in patients with~     refractory solid tumors; and 3) To gather preliminary efficacy data. The method of testing is~     open-label, sequential cohort, dose-escalation study.~   "
271488|NCT00031018|"~     In this phase I-II parallel design, randomized, double-blind clinical trial we will determine~     if 3,000 or 30,000 units ingested hrIFN-a prevents deterioration of cognitive functioning in~     patients with dementia of Alzheimer's type (AD) and whether ingested hrIFN-a treatment~     decreases acute phase reactants and pro-inflammatory cytokine IL-6 in mild to moderate AD. We~     predict that the novel anti-inflammatory agent ingested human recombinant interferon alpha~     (hrIFN-a) will modulate inflammation and inhibit the natural history of AD progression. If~     you are eligible, you will receive Aricept for 5 weeks (donezepil) and thereafter in addition~     to Aricept either placebo (inactive substance) or interferon alpha at 3,000 or 30,000 units~     every day for 12 months.~   "
271489|NCT00031005|"~     This study will investigate the safety and effectiveness of a modified stem cell transplant~     procedure for treating leukocyte adhesion deficiency (LAD). LAD is an inherited blood~     disorder of leukocytes (infection-fighting white blood cells) that leaves patients vulnerable~     to life-threatening infections. Transplantation of donated stem cells (cells produced by the~     bone marrow that mature into blood cells) can improve the immune system of patients with LAD.~     However, this procedure carries a significant risk of death, particularly in patients with~     active infection because it requires completely suppressing the immune system with high-dose~     chemotherapy and radiation. In addition, T-cells (a type of white blood cell) from the donor~     may cause what is called graft vs. host disease (GvHD), in which the donor cells recognize~     the patient's cells as foreign and mount an immune response to destroy them. To try to reduce~     these risks, the donor's T-cells will be removed from the rest of the stem cells to be~     transplanted.~      Patients with LAD who weigh at least 12 kg (26.4 LB), who do not have an active infection,~     and who have a family member that is a well-matched donor may be eligible for this study.~     Pregnant or breast feeding women may not participate. Candidates will have a medical history,~     physical examination and blood tests, lung and heart function tests, X-rays or computed~     tomography (CT) scans of the body, and dental and eye examinations. They will fill out~     questionnaires that measure emotional well being, quality of life and intelligence (the~     ability to learn and understand).~      Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF~     will be injected under the skin for several days to move stem cells from the bone marrow to~     the bloodstream. The stem cells will be collected by apheresis, where blood is drawn through~     a needle placed in one arm and pumped into a machine separating and removing the required~     cells. The rest of the blood is then returned through a needle in the other arm.~      Before the transplant, a central venous line (large plastic tube) is placed into a major~     vein. This tube can stay in the body and be used during the entire treatment period to~     deliver the donated stem cells, give medications, transfuse blood, if needed, and withdraw~     blood samples. Several days before the transplant procedure, patients will begin a~     conditioning regimen of low-dose chemotherapy with cyclophosphamide, fludarabine, and Campath~     1H. When the conditioning therapy is completed, the stem cells will be infused. To help~     prevent rejection of donor cells, cyclosporine will be given by mouth or by vein starting 1~     month after the transplant procedure.~      The average hospital stay for stem cell transplantation is 21 days. After discharge, patients~     will return for follow-up clinic visits weekly or twice weekly for 2 to 3 months. These~     visits will include a symptom check, physical examination, and blood tests. Subsequent visits~     will be scheduled at 4, 6, 9, and 12 months after the transplant, or more often if required,~     and then yearly~   "
271490|NCT00030992|"~     This study will examine whether the experimental drug BMS 247550 (Ixabepilone) is an~     effective treatment for kidney cancer. BMS 247550 belongs to a class of drugs called~     epothilones that interfere with the ability of cancer cells to divide. In the way they kill~     cells, they are very similar to a class of compounds known as the taxanes, which include the~     drug Taxol. Other characteristics of the epothilones, however, enable them to work in cells~     that are resistant to Taxol.~      Patients 18 years of age or older with kidney cancer that has not spread to the central~     nervous system (unless the brain tumor has remained stable for at least six months after~     surgical or radiation treatment) may be eligible for this study. Pregnant or nursing women~     may not participate. Candidates are screened with various tests that may include blood and~     urine tests, electrocardiogram (EKG), and chest x-ray. Computerized tomography (CT) scans or~     X-rays, and possibly nuclear medicine studies may be done to determine the extent of disease.~      Participants receive BMS 247550 by a 1-hour infusion into a vein for 5 consecutive days (days~     1, 2, 3, 4 and 5) of each 21-day treatment cycle. Patients must stay in the National~     Institutes of Health (NIH) area near Bethesda, Maryland, for 7 to 8 days during the first~     treatment cycle and for the 5 days of treatment in subsequent cycles. The total number of~     cycles will vary among patients, depending on their individual clinical situation. The drug~     dose may be increased gradually in subsequent cycles in patients who can tolerate such~     increases. In addition, participants undergo the following tests and procedures:~        -  Periodic physical examinations and frequent blood tests~        -  X-ray and other imaging studies to determine if the tumor is responding to the~          treatment.~        -  Tumor biopsies to confirm the diagnosis or spread of tumor and to examine the reaction~          of certain proteins in cancer cells to BMS 247550. Two biopsies will be done. For this~          procedure, a small piece of tumor tissue is withdrawn through a needle under local~          anesthetic.~      Treatment will be stopped in patients whose tumor grows while receiving BMS 247550. Patients~     whose tumor disappears completely will be followed at NIH periodically for examinations and~     tests. Patients whose disease does not completely resolve or whose disease recurs may be~     advised of other appropriate research protocols at NIH or, if none are available, will be~     returned to the care of their local doctor.~   "
271491|NCT00030979|"~     This study will evaluate the safety and effectiveness of donepezil (Aricept) for treating~     mild dementia in patients with Parkinson's disease. Donepezil is approved for treating~     patients with Alzheimer's disease, whose memory and cognition problems are similar to those~     of patients with Parkinson's disease who are affected by dementia. Donepezil prevents the~     breakdown of a chemical messenger called acetylcholine, which is involved in memory and other~     cognitive functions, and may improve cognition in patients.~      Patients 40 years of age and older with Parkinson's disease who have mild to moderate~     dementia may be eligible for this 6-month study. It involves 6 clinic visits of approximately~     2 hours each, described below. Candidates will be screened for participation during Visit 1.~        -  Visit 1 (screening visit): Study candidates will have a medical history, physical and~          neurological examinations, electrocardiogram (EKG), and possibly blood tests. They will~          also undergo neuropsychological testing (tests of memory, language, mood and, other~          brain functions) and fill out a quality of life questionnaire. Those enrolled will be~          randomly assigned to receive either donepezil (5 mg per day) or placebo-a look-alike~          pill with no active ingredients. After 4 weeks, the dose of donepezil will be increased~          to 10 mg per day. Patients who do not tolerate the higher dose will have it reduced to 5~          mg. Those who do not tolerate the 5-mg dose will be taken off medication but will~          continue to be followed and tested.~        -  Visit 2 (week 7): Patients will have a neurological examination and neuropsychological~          testing and will fill out a quality of life questionnaire.~        -  Visit 3 (week 10): Patients will repeat the evaluations done during visit 2 and will~          stop taking the study medication.~        -  Visit 4 (week 16): Patients will repeat the evaluations done during visit 2 and will~          have their study medication switched. That is, patients previously on placebo will be~          switched to donepezil, and patients who were taking donepezil will be switched to~          placebo. After 4 weeks, the dose of donepezil will be increased to 10 mg per day.~          Patients who do not tolerate the higher dose will have it reduced to 5 mg. Those who do~          not tolerate the 5-mg dose will be taken off medication but will continue to be followed~          and tested.~        -  Visits 5 and 6 (weeks 23 and 26): Patients will repeat the evaluations done during visit~          2.~      This study is being conducted at the National Institutes of Health, the University of~     Pennsylvania, and Northwestern University~   "
271492|NCT00030966|"~     The purpose of this study is to determine if natalizumab in combination with AVONEX is safe~     and effective in delaying progression of individuals diagnosed with relapsing remitting~     Multiple Sclerosis (MS).~   "
271535|NCT00029640|"~     This study seeks to learn about brain function in adolescents with depression and to~     determine whether adding lithium carbonate to antidepressant medication can reduce depression~     in children and adolescents. Functional magnetic resonance imaging (fMRI) and magnetic~     resonance spectroscopy (MRS) will examine brain chemistry and function.~   "
271751|NCT00021762|"~     The purpose of this study is to see whether or not an HIV vaccination will help the body~     control the amount of HIV virus in blood (viral load) in patients who are not taking anti-HIV~     medicines.~      Doctors are not sure why the body fails to control HIV viral load in most people infected~     with HIV. The vaccine Remune has been shown to boost part of the body's immune response to~     HIV in patients whose viral load has been lowered with anti-HIV drugs. This study will test~     the ability of Remune to improve the body's immune response and to lower HIV viral load in~     patients who stop taking anti-HIV drugs for short periods of time.~   "
271493|NCT00030953|"~     This study will use magnetic resonance imaging (MRI) and magnetic resonance spectroscopy~     (MRS) of the brain to try to gain a better understanding of the disease process in Tourette s~     syndrome, a neuropsychiatric disorder characterized by motor and vocal tics. Tourette s~     syndrome is also associated with behavioral and emotional disturbances, including symptoms of~     attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD). MRI~     and MRS show chemical substances in the brain. Findings in normal volunteers will be compared~     with those of patients.~      Healthy volunteers and patients with Tourette s syndrome 14 years of age and older may be~     eligible for this study. Volunteers will be screened with a medical history and physical and~     neurological examinations. Patients will be screened through NINDS protocol 93-N-0202.~      Participants will undergo MRI and MRS. MRI uses a strong magnetic field and radio waves to~     visualize brain anatomy and chemistry. For this study, the subject lies on a stretcher, which~     is moved into a strong magnetic field (the MRI scanner). Earplugs are worn to muffle loud~     thumping noises caused by the electrical switching of the radio frequency circuits. During~     the study, the subject lies still during each scan, for 1 to 8 minutes at a time. Total~     scanning time varies from 20 minutes to 2 hours, with most examinations lasting between 45~     and 90 minutes. The subject can speak through an intercom with the staff member performing~     the study at all times during the procedure. Up to 5 studies may be performed.~   "
271494|NCT00030940|"~     This study will explore the role of various immune factors involved in producing the disease~     symptoms in stiff-person syndrome (SPS) and follow disease progression in patients. SPS is a~     progressive disease in which unexpected noises, touches or stressful events set off muscle~     spasms and stiffness. It is thought to be an autoimmune disease in which the body produces~     antibodies that attack certain healthy tissues. A better understanding of the disease may~     help researchers design new therapies.~      Patients of any age with SPS may be eligible for this study, except those who:~        -  Lack of serum anti-GAD antibodies~        -  Have very advanced disease that precludes traveling~        -  Have severe cardiovascular, renal, or other end-organ-disease states~      Candidates will be screened with a medical history and physical and neurological examinations~     to confirm the diagnosis of SPS.~      After screening, those enrolled in the study will be followed at the NIH Clinical Center~     every 6 months for 2 years (months 6, 12, 18, and 24) to have the following tests and~     procedures:~        -  Physical and neurological examinations and review of symptoms (every visit)~        -  Blood draw for routine tests and for research studies (every visit)~        -  Stiffness assessment (every visit) - Patients are asked a series of questions about~          their stiffness, which physicians rate according to the number of stiff areas (e.g.,~          0-no stiff areas; 1-stiffness of the lower trunk; 2-stiffness of the upper trunk, etc.).~        -  Lymphapheresis (at the beginning of the study and at 12 months) - This is a procedure~          for collecting large quantities of white blood cells. A needle is placed in a vein in~          the arm. Blood flows from the vein through a plastic tube (catheter) into a machine that~          spins the blood, separating it into its components. The white blood cells (lymphocytes)~          are removed, and the rest of the blood-plasma, red cells and platelets-is returned to~          the body through a second needle placed in the other arm.~        -  Electrophysiologic studies - These studies include electromyography and nerve conduction~          testing. For electromyography, a small needle is inserted into a few muscles and the~          patient is asked to relax or to contract the muscles. The electrical activity of the~          muscle cells is recorded and analyzed by a computer. For nerve conduction testing,~          nerves are stimulated through small wire electrodes attached to the skin, and the~          response is recorded and analyzed.~        -  Lumbar puncture (at the beginning of the study and at 12 months) - This procedure is~          done to examine the cerebrospinal fluid (CSF), which bathes the brain and spinal cord.~          After a local anesthetic is administered, a needle is inserted in the space between the~          bones in the lower back where the CSF circulates below the spinal cord. About 2~          tablespoons of fluid is collected through the needle.~   "
271495|NCT00030238|"~     This study will examine the health effects of calcium supplements in overweight adults.~     Overweight adults often eat a diet low in calcium. Some studies have found low calcium intake~     in people who have some of the medical problems often seen in overweight adults. This study~     will see if extra calcium improves the health of overweight adults.~      Volunteers in general good health 18 years of age or older who are overweight (body mass~     index equal to or greater than 25 kilograms per square meter of body surface) may be eligible~     for this study. Women who are pregnant or breastfeeding may not participate. The study~     includes four visits, described below.~      Visit 1~      Volunteers will be screened for participation in the study with a medical history, physical~     examination, and blood and urine tests. At home, they will collect a 24-hour urine sample;~     fill out questionnaires to assess their average calcium intake; and record their food intake~     for 7 days. Those enrolled in the study will continue with the next 3 visits.~      Visit 2~      Participants will complete a physical activity questionnaire, have their food diary reviewed,~     and meet with a dietitian for nutritional counseling. Triceps fold thickness and waist and~     hip circumferences will be measured three times. Body composition will be analyzed by a DEXA~     study. For this procedure, the subject lies on a flat table while a small dose of X-rays is~     passed through the body.~      Participants will be randomly assigned to take either calcium carbonate (1500 mg/day) or~     placebo capsules twice a day by mouth for 2 years. (The placebo looks like the calcium~     capsules but contains no calcium.) They will receive a 6-month supply of study capsules~     during visit 2 and return to NIH every 6 months for the next supply. They will also be sent~     questionnaires by mail every 3 months to complete information about health problems and how~     often the study capsules are being taken.~      Visits 3 and 4~      Visit 3 is scheduled after participants have taken the study capsules for 1 year; visit 4 is~     scheduled after 2 years (the end of the study). At each of these visits, participants will~     have a DEXA scan, blood and urine tests, blood pressure measurements, and measurements of~     height, weight, waist and hip circumference. They will complete questionnaires about their~     medical history, side effects of the study medications, dietary calcium intake, and physical~     activity, and they will meet with one of the study investigators to talk about any concerns~     regarding the study. At the fourth visit, participants will answer some additional questions~     about their study participation and return the Diet History Questionnaire that was mailed to~     them before the visit.~   "
271496|NCT00030225|"~     The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver~     Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver~     transplant or bridge to native liver recovery.~   "
271497|NCT00030212|"~     This study will examine the abnormal immune response in patients with sporadic inclusion body~     myositis (s-IBM)-the most common inflammatory muscle disease in people over the age of 50.~     s-IBM progresses steadily and may lead to severe weakness and wasting of arm and leg muscles.~     Patients may become unable to perform daily living activities and be confined to wheelchairs.~     s-IBM is thought to be an autoimmune disease, in which the body's own immune system attacks~     healthy muscles. This study will explore the causes of the muscle tissue inflammation that is~     responsible for destruction of muscle fibers and weakness in this disease. Information from~     the study may help in the development of an effective treatment for this disease.~      Patients with s-IBM may be eligible for this study. Those who are unable to travel or who~     have severe cardiovascular, renal or other end-stage organ disease will be excluded.~     Candidates will be screened for eligibility with a medical history and physical and~     neurological examinations.~      Participants will be seen at the NIH Clinical Center every six months over a 12-month period~     (visits at enrollment, 6 months and 12 months) either on an inpatient or outpatient basis,~     depending on their disease severity. Each 2- to 3-day visit will involve the following tests~     and evaluations:~        -  Blood samples for routine laboratory tests are collected at every visit. Additional~          blood for research studies is collected at 12 months.~        -  Quantitative muscle strength testing is done at every visit. The patient pulls against~          straps connected to dynamometers (devices that measure muscle power) to evaluate~          strength of the main muscle groups in the arms and legs.~        -  Lymphapheresis is done at enrollment and at 12 months. This is a procedure for~          collecting quantities of lymphocytes (white blood cells that are an important part of~          the immune system). Blood is collected through a needle placed in an arm vein and~          circulated through a machine that spins it, separating it into its components. The~          lymphocytes are removed and the rest of the blood (red cells, platelets and plasma) is~          returned to the body through the same needle or another needle placed in the other arm.~        -  Electrophysiologic studies (electromyography and nerve conduction testing) are done at~          enrollment and 12 months. Electromyography evaluates the electrical activity of muscles.~          A small needle is inserted into the muscle and the patient is asked to relax or to~          contract the muscle. For nerve conduction testing, nerves are stimulated by electrodes~          (small wires taped to the skin over the muscle).~        -  Muscle biopsy is done at enrollment and 12 months. A sample of muscle tissue (about the~          size of a lima bean) from an arm or leg is surgically removed to confirm the diagnosis~          of s-IBM and for analysis of proteins involved in the muscle inflammation process. A~          local anesthetic is used to numb the area before the surgery and the wound is closed~          with stitches.~   "
271934|NCT00002414|"~     The purpose of this study is to see if it is safe and effective to give CPI-1189 to patients~     with AIDS dementia.~      Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of~     memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.~   "
271498|NCT00030199|"~     This study will use transcranial magnetic stimulation (TMS) to study how the brain controls~     movement of muscles in the face-in particular, those involved in eye blinking. TMS is a~     procedure that activates areas of the brain with magnetic pulses that travel through the~     scalp and the skull.~      Healthy normal volunteers 21 years of age and older may be eligible for this study. They must~     be free of any serious medical illness, have no neurological or psychiatric disorders or~     history of seizures, and must not be taking any medications that can affect nervous system~     function.~      Participants will undergo TMS and the electrical activity in muscles activated by the~     stimulation will be recorded. For TMS, an insulated wire coil is placed on the patient's~     scalp, and a brief electrical current is passed through the coil. This creates a magnetic~     pulse that travels through the scalp and skull and causes small electrical currents in the~     outer part of the brain. If the coil is placed over a nerve that controls muscles, there may~     be a twitch in the muscles, sometimes large enough to move the face. In other cases, there~     may be a feeling of movement or tingling sensation in the face. Stimulation over the muscles~     on the side of the head may cause some discomfort there or twitching of the jaw. During the~     stimulation, subjects may be asked to tense certain muscles slightly or perform other simple~     actions.~      Electrical activity of the muscles activated by the stimulation is recorded. This is done~     with both metal electrodes taped to the skin over the muscle and with fine needle electrodes~     inserted into the muscles around the eyes.~      The study usually takes less than 3 hours, with frequent breaks. If more time is required,~     the study will be broken into more than one session.~   "
271499|NCT00030186|"~     The purpose of this study is to determine the response rate of patients with refractory,~     relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at~     a dosage of 60 mg 2 times a day.~   "
271500|NCT00030173|"~     Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic~     arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis,~     motility, secretion and proliferation, the observed antitumor effects of epothilones have~     been attributed to their ability to initiate cell death by inhibiting such processes.~     Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines,~     equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor~     activity in a range of xenograft models, including paclitaxel-resistant xenografts.~     Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug~     resistant activity overexpressing p-glycoprotein.~   "
271501|NCT00030160|"~     Recent obesity prevalence increases have made obesity prevention a clear and pressing public~     health issue. The average US. woman gains about 0.5 kg per year. Overweight women aged 25 to~     44 have a higher prevalence of significant weight gains (BMI increases of > 5 kg/m2) than men~     or older or thinner women. The difficulty in successfully losing weight and maintaining~     weight loss has resulted in recommendations from several expert panels to advise overweight~     and mildly obese individuals free of co-morbidities to avoid weight gains rather than to lose~     weight. Physical activity is observed to decline with age while caloric intake remains stable~     or declines slightly. There is strong observational evidence that physical activity could~     prevent or attenuate age associated fat gains. This randomized, controlled behavioral~     intervention trial will test the hypothesis that regular participation in a twice weekly~     strength training program over 2 years, can prevent age associated body fat increases (total~     and abdominal fat) in 80 overweight to mildly obese premenopausal women between the ages of~     25 and 44 years, compared to a 'standard care' group (n=80). The overall aim of the study is~     to prevent body fat gains and to reduce health risks associated with obesity. Treatment~     effects will be assessed for insulin sensitivity, blood pressure, blood lipids, muscle~     strength, and psychosocial predictors of strength training adherence. The innovation of this~     approach rests in its simplicity and the minimal time requirement for full participation (2~     exercise sessions weekly). A preliminary study of this innovative approach resulted in 88%~     exercise session attendance over 12 months and maintenance of treatment effects on total body~     fat percentage to the end of pilot study measurements (9 months). This supports the~     feasibility and potential for long term efficacy of the proposed intervention approach. The~     long-term implication of success in this efficacy trial would be that this modest behavior~     change could prevent the fat gains and associated co-morbidities commonly observed in midlife~     women.~   "
271502|NCT00030147|"~     The purpose of this study is to evaluate the effectiveness of the drugs raloxifene and~     rimostil in treating perimenopause-related depression.~      Perimenopause-related mood disorders cause significant distress to a large number of women;~     the demand for effective therapies to treat these mood disorders is considerable. Estradiol~     replacement therapy (ERT) has demonstrated efficacy in treating perimenopause-related~     depression. Unfortunately, there are long-term risks associated with ERT. Selective estrogen~     receptor modulators (SERMS), such as raloxifene, and phytoestrogens, such as rimostil, have~     estrogen-like properties and may offer a safer alternative to ERT. The effect of SERMS and~     phytoestrogens on mood and cognitive functioning need to be examined in women with~     perimenopause-related depression.~      Participants in this study will undergo a medical history, physical examination,~     electrocardiogram (EKG), and blood and urine tests. They will then be randomly assigned to~     receive one of four treatments for 8 weeks: raloxifene pills plus a placebo (an inactive~     substance) skin patch, rimostil pills plus placebo skin patch, estradiol skin patch plus~     placebo pills, or placebo patch plus placebo pills. Participants will have clinic visits~     every 2 weeks. During the visits, blood will be drawn and participants will meet with staff~     members and complete symptom self-rating scales. A urine and blood sample will be collected~     at the beginning and end of the study. At the end of the study, participants who received~     placebo or whose study medication was ineffective will be offered treatment with standard~     antidepressant medications for 8 weeks. Non-menstruating women will receive progesterone for~     10 days to induce menstrual bleeding and shedding of the inner layer of the uterus, which may~     have been stimulated by the study medications.~   "
271536|NCT00029627|"~     The purpose of this study is to investigate the role of brain receptors called~     alpha2-adrenoreceptors in regulating the sympathetic nervous system, which maintains the~     supply of blood and fuel to the body's organs in times of stress, fear, anger, or exercise.~      Alpha(2)-adrenergic receptors (alpha(2)-AR) play a role in a variety of physiological~     functions. There are three subtypes of alpha(2)-ARs, and their differences are unknown. This~     study will examine the functional roles of these three subtypes by comparing the behavioral,~     biochemical, psychophysiological, and autonomic function effects of the alpha(2)-AR drugs~     clonidine and yohimbine.~      Participants in this study will undergo a physical examination, electrocardiogram (ECG), and~     blood, urine, and saliva tests. Women will have hormone tests to determine the time of their~     last period and the time of their next ovulation. Participants will undergo~     neuropsychological testing and other procedures.~   "
271537|NCT00029614|"~     The purpose of this study is to compare the effectiveness and safety of atomoxetine in the~     treatment of adolescents with coexisting alcohol or substance use disorders and Attention~     Deficit Hyperactivity Disorder (ADHD).~   "
271503|NCT00030134|"~     This protocol will collect information needed to design a clinical study for the symptoms and~     problems of women with Fabry disease, an inherited metabolic disorder. In this disease, an~     enzyme called a-galactosidase A, which normally breaks down fatty substances called~     glycolipids, does not function properly. The resulting accumulation of glycolipids in various~     tissues causes arm and leg pain, skin lesions, and problems with the kidneys, heart, nerves,~     and blood vessels. This protocol does not involve any experimental drug treatments, but~     participants may be offered enrollment in future studies and registries.~      Women 18 years of age and older with Fabry disease who have not had enzyme replacement~     therapy may participate in this study. Pregnant women are eligible, but may be excluded from~     certain procedures, such as magnetic resonance imaging (MRI).~      Participants will have the following tests and procedures over a 3-day period:~        -  Personal and family medical history~        -  Physical, neurological, and eye examinations~        -  Blood and urine tests~        -  Electrocardiogram (ECG) to measure electrical activity of the heart~        -  Echocardiogram (ultrasound) to examine the heart muscles and pumping action~        -  Magnetic resonance imaging (MRI) to examine the brain. This test uses a magnetic field~          and radio waves to produce images of the brain. The patient lies in a narrow cylinder~          (the MRI scanner) during the imaging and may talk with staff at any time during the~          procedure.~        -  Magnetic resonance angiogram (MRA) to examine the blood vessels in the head and neck.~          This procedure is similar to MRI.~        -  Genotyping to confirm the diagnosis of Fabry disease. DNA from a blood sample will be~          examined for the gene associated with Fabry disease.~        -  Skin punch biopsy for microscopic examination of tissue. A piece of skin tissue about~          1/8-inch thick is removed with a cookie cutter-like instrument.~      Participants will also complete two questionnaires regarding pain and quality of life. They~     will be asked to stop taking pain medications for 7 days before completing the pain~     questionnaire, but may resume medications before 7 days if the pain is too intense. The~     questionnaire will be completed by telephone interview.~      Patients will also be asked to keep a diary of pain medications taken for 7 days while on the~     study.~   "
271504|NCT00030121|"~     The purpose of this study is to determine whether Carperitide is safe and effective in the~     management of Acute Respiratory Distress Syndrome (ARDS).~   "
271505|NCT00030069|"~     This is a study to determine the response rate in patients with myelodysplastic syndromes~     treated with calcitriol and dexamethasone.~   "
271506|NCT00030056|"~     This is a study to determine the efficacy and safety of granulocyte-macrophage~     colony-stimulating factor (GM-CSF, sargramostim) administered subcutaneously to patients with~     pulmonary alveolar proteinosis (PAP).~   "
271507|NCT00030043|"~     This is a study to gather some information on the safety and efficacy of the penetrating~     auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.~   "
271508|NCT00030030|"~     To investigate the effect of silymarin, derived from the milk thistle plant, Silybum~     marianum, in preventing and reversing the complications of chronic infection with hepatitis C~     virus and/or clearing hepatitis C infections.~   "
271509|NCT00030004|"~     This study is designed to determine whether a medicine that can produce temporary amnesia~     (midazolam) can be used to block the memory of treatment with spinal manipulation. This is~     important since any study that is designed to determine whether spinal manipulation is~     effective would be better if patients were not aware of whether or not they were treated.~     This would allow a true assessment of treatment effects without the complication of a strong~     placebo effect that manipulative treatment may produce.~   "
271510|NCT00029991|"~     This study will determine if a highly standardized herbal extract of the leaves of the Ginkgo~     Biloba tree will benefit patients who have pain on walking due to narrowing of the arteries~     of the legs.~   "
271511|NCT00029978|"~     The purpose of this study is to determine whether visual evoked potentials generated in one~     human brain by photostimulation can generate a correlated EEG signal in the brain of another~     human subject who is located at a distance and who is not visually stimulated.~   "
271512|NCT00029965|"~     This study will evaluate children with glycosphingolipid (GSL) storage disorders to~     investigate brain changes that cause nervous system degeneration. No experimental treatments~     are offered in this study; participants will receive standard medical care for their disease.~     The information from this study may help researchers develop new therapies for these~     disorders and monitor the effects of treatment.~      Patients of any age with Tay-Sachs disease, Sandhoff disease, GM1 gangliosidosis, or type 2~     Gaucher disease may be eligible for this study.~      Participants will be admitted to the NIH Clinical Center for 4 to 5 days every 6 months for a~     clinical evaluation involving the following tests and procedures:~        -  Medical history~        -  Physical, neurologic, and eye examinations~        -  Developmental evaluations by a physical therapist, nutritionist and psychologist~        -  Blood tests to check nutritional status, liver and kidney function, and, in patients~          treated for seizures, level of anti-seizure drugs. Some blood will also be used for~          research purposes.~        -  Urinalysis to check urine sugar levels and kidney function~        -  Skin biopsy to obtain cells to grow in culture. The biopsy area is numbed with an~          anesthetic cream and a 1/8-inch piece of skin is removed with a circular punch and~          scissors.~        -  Genetic analysis of DNA to screen for mutations responsible for the patient s GSL~          storage disorder~        -  Magnetic resonance imaging (MRI) brain scans. Children with type 2 Gaucher disease,~          Sandhoff disease and GM1 gangliosidosis will also have liver and spleen scans. Brain~          scans will be done every 6 months the first year. After that, they may be done less~          often, depending on the results. For the MRI, the child lies still in a narrow cylinder~          (the scanner). A magnetic field and radio waves are used to produce pictures of the~          organs under study. (Children will be sedated for MRI. Children who cannot be sedated~          will not have this test.)~        -  Electroencephalogram (EEG) to measure electrical activity of the brain and detect~          possible seizures. For this test, electrodes (small metal discs attached to wires) are~          attached to the child s head with a paste and the brain waves (electrical activity) are~          recorded while the child rests quietly.~        -  Brainstem auditory evoked response (BAER) to measure hearing. Electrodes are attached to~          the child s head (similar to the EEG procedure) and the brain waves are recorded when a~          sound stimulation is given.~        -  Lumbar puncture (spinal tap) to study proteins in the cerebrospinal fluid, which bathes~          the brain and spinal cord. A needle is inserted in the space between the bones~          (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the~          needle. This test is done under anesthetic at the same time the MRI is done. If the~          child cannot be sedated, a local anesthetic will be used.~   "
271513|NCT00029952|"~     Although most patients with hypercortisolism can be diagnosed and treated the long-term~     effects of hypercortisolism and its treatment are unknown. This study will attempt to answer~     the following questions:~        1. What is the rate of perioperative complications? Patients with Cushing syndrome often~          undergo transsphenoidal surgery of the pituitary gland as treatment for the disease.~          During this surgical procedure the pituitary gland is reached by passing through the~          sphenoid bone. The risk for patients to develop hypopituitarism in the immediate~          postoperative period is unknown. Patients with Cushing syndrome have abnormal levels of~          hormones circulating in the blood and affects of the surgery are often not apparent~          until long after the procedure.~        2. What is the recurrence rate? The recurrence rate of the disease has been estimated~          between 5 - 10%. However, these figures have not been confirmed. If the actual rate of~          recurrence is higher than estimated many patients may elect to undergo radiation therapy~          which has a lower rate of recurrence.~        3. Do any factors in the immediate postoperative period predict who will experience a~          recurrence of Cushing syndrome?~        4. What are the long-term complications of hypercortisolism? Studies have shown that~          patients with hypercortisolism have a four times greater risk of death than people of~          the same age without hypercortisolism. Researchers tend to believe this figure is too~          high. However, it is well established that hypercortisolism weakens bones (decreased~          bone density), causes secondary hypogonadism, increases levels of fat in the blood~          (hyperlipidemia), and decreases thyroid function (hypothyroidism). The potential for~          these conditions to be reversed is not known.~      These questions will be addressed by blood and urine sampling in the postoperative period,~     and by outpatient follow-up and periodic questionnaires in the first 10 years after curative~     surgery for Cushing syndrome performed at the NIH.~   "
271763|NCT00017693|"~     The purpose is to measure the effectiveness of recombinant human interleukin-4 receptor~     (IL-4R) in treating asthma.~      Asthma can be caused by the allergic response from breathing in certain irritants.~     Interleukin 4 (IL-4), which is naturally produced by the body, plays a major role in this~     allergic response. Doctors feel that IL-4 activity may be stopped by giving IL-4R, a product~     that binds to IL-4, and thereby decrease the problems of asthma.~   "
271514|NCT00029939|"~     This study will use electroencephalography (EEG) to examine how the brain prepares for~     movement. It will look at 1) what changes occur in a person's brain just before voluntary~     movement, 2) when the changes occur, 3) how consistent the changes are, and 4) how the~     changes vary from person to person. The information from this study will be applied to other~     studies, such as exploring how brain changes that signal movement can be used to control~     prostheses in patients with spinal cord injuries or stroke.~      Healthy normal volunteers 18 years of age and older may be eligible for this study. People~     with neurologic or psychiatric disorders and people taking medicines that may affect brain~     signals (e.g., Valium) may not participate.~      Participants will come to the NIH Clinical Center on two separate days for testing sessions~     of 2 to 3 hours each. At each session, an EEG cap will be placed on the head to record brain~     signals, and electrodes will be placed on the arms to record movement. Subjects will perform~     simple movements during the EEG recording, such as flexing their arm of clenching their fist.~     Researchers will use the first recording to determine the pattern of how the brain prepares~     for movement. During the second recording, they will try to predict the subjects' movements,~     based on the patterns discerned in the first recording.~   "
271515|NCT00029926|"~     This study will examine whether PET imaging can reveal what is happening in lymph nodes of~     patients with systemic lupus erythematosus, or lupus, during periods of active disease.~     Patients may have periods of active disease when they may feel sick with fever, fatigue, and~     aching or swollen joints. Their blood tests are abnormal and their kidney, lungs or heart may~     be affected. At other times, the disease is inactive, and patients feel well, their blood is~     normal, and there is no evidence of organ disease.~      In lupus, like other autoimmune diseases, the body's immune system attacks it own healthy~     tissues. Activated lymphocytes (a type of immune cell) lead to the production of antibodies~     and chemical signals that contribute to the disease process. In animals with lupus, these~     cells are activated in the lymphoid organs, such as the lymph nodes or spleen. It is not~     known exactly where these cells are activated in humans. Because some lymph nodes are located~     deep inside the chest and abdomen; surgery is currently the only way to examining them. PET~     imaging may provide an alternative, non-invasive, means of obtaining information on lymph~     node activity in humans. This test uses a radioactive sugar molecule called F18-FDG to find~     areas of increased cellular activity in the body. (Cells use sugar for fuel, so active cells,~     such as active lymphocytes, uses more FDG than other body tissues.) This study will determine~     whether PET can detect these areas of increased activity in lupus during active disease.~      Patients with active or inactive lupus may be eligible for this study. Candidates are~     screened with a history, physical examination, and routine blood and urine tests. Women who~     are pregnant or breastfeeding may not participate.~      Participants will undergo PET scanning. On the day of the scan they have a brief medical~     history and physical examination and a blood sample is drawn to check blood count and look~     for markers of lymphocyte activation. Then, a small plastic tube (catheter) is placed into a~     vein in the patient's arm, the FDG is injected through the catheter, and the patient rests~     for an hour. For the scan, the patient lies flat in a cradle that is moved into the central~     hole of the doughnut-shaped PET camera, and pictures are taken over the next 2 hours, with~     the patient lies quietly, without moving the head or arms. After the scan is finished, the~     patient empties the bladder approximately every hour for 6 hours to excrete the radioactive~     sugar.~   "
271516|NCT00029913|"~     Despite risk reduction counseling, some individuals in HIV vaccine trials or vaccine~     preparedness studies may engage in risk behavior that results in HIV infection. The purpose~     of the HVTN 403 study is to find out more about how persons respond to HIV infection if they~     have received an experimental HIV-1 vaccine before they became HIV infected.~      Some people in HVTN 403 received an experimental HIV vaccine as a participant in a clinical~     trial before getting infected with HIV. Other people in this study were in a vaccine~     preparedness study when they got infected with HIV. None of these individuals became infected~     with HIV as result of their participation in an HIV vaccine or vaccine preparedness study.~     HVTN 403 will compare immune responses between those who previously received an experimental~     HIV vaccine and those who did not. Information learned from this study may be important in~     guiding future developments of new HIV vaccines and other treatments for HIV and AIDS.~   "
271517|NCT00029900|"~     This is a study to determine the safety and toxicity of increasing doses of arginine~     deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic~     melanoma.~   "
271518|NCT00029874|"~     This is a study to determine whether treatment with minocycline is safe and tolerable in~     patients with Huntington's disease (HD) and whether minocycline reduces symptoms of HD in~     these patients.~   "
271519|NCT00029861|"~     To assess the effects of weight loss and weight maintenance over a period of two years when~     prescribed with a hypocaloric diet in obese patients with or without comorbidities~   "
271520|NCT00029848|"~     To assess the effect on weight loss and weight maintenance over a period of one year when~     prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes~   "
271521|NCT00029835|"~     To assess the effect on weight loss and weight maintenance over a period of one year when~     prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia~   "
271522|NCT00029822|"~     A study to determine the effect on prevention of Acute Urinary Retention (inability to~     urinate) in males with an enlarged prostate, also known as BPH.~        -  Free study-related medical care provided.~   "
271523|NCT00029809|"~     This study will compare the effects of two Chinese and one Western exercise modalities on the~     signs and symptoms of Parkinson's disease.~   "
271524|NCT00029796|"~     This is a randomized, double-blinded dietary intervention in hemodialysis patients to~     determine the clinical and metabolic effects of soy isoflavones on disease activity,~     including improvement of blood markers of acute-phase response, and decreased blood levels of~     markers of metabolic bone disease.~   "
271525|NCT00029783|"~     This study will assess whether distant healing effects survival time and loss of function for~     glioblastoma patients.~   "
271526|NCT00029770|"~     This study will compare the effectiveness of chiropractic care, medications, and self-care on~     neck pain, a very common condition. The broad, long-term objective of this study is to~     identify effective therapies for neck pain sufferers and to increase understanding of neck~     pain conditions.~   "
271559|NCT00029237|"~     The overall purpose of the proposed study is to determine whether three short-term stress~     management interventions along with booster strategies will improve and sustain improvements~     in psychosocial functioning, quality of life, and somatic health among persons with varying~     stages of HIV disease. The 10-week group interventions are designed to reduce perceived~     stress and increase coping effectiveness and include cognitive-behavioral stress management~     focused on positively living (+LIVE), focused Tai Chi (TCHI) training, and spiritual growth~     groups (SPRT). Effects of the interventions will be evaluated immediately upon completion of~     the group training and at 6 months and 12 months following stress management training.~   "
271560|NCT00029224|"~     Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or~     prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be~     evaluated, as well as time in chair, quality of life and safety of Zometa.~   "
271527|NCT00029757|"~     Background: The use of estrogen in postmenopausal (or surgically menopausal) women is a~     common practice. Compliance is problematic in that estimates show only 1/3 of women use~     hormone replacement therapy (HRT) and only 30% are compliant. Estrogen has many documented~     benefits including symptomatic relief of hot flashes, improvement of the dry vagina and~     dyspareunia. Estrogen has been found to improve bone mineral density and increase the high-~     density lipoprotein portion of a cholesterol panel. To improve compliance and to provide an~     alternate method of delivery, we propose the use of estrogen which is admixed in toothpaste~     and propose to study the absorption, rate of build-up and rate of decline.~      Hypothesis: Estrogen can potentially be absorbed systemically when toothpaste is admixed with~     estradiol and is applied in a timed, consistent fashion to postmenopausal or surgically~     postmenopausal women, not on HRT. Absorption takes place across the buccal mucosa.~      Specific Aims:1) To estimate the systemic absorption of estrogen from daily use of estrogen~     containing toothpaste.~      2) To estimate the rate of build-up of serum estrogen levels based upon daily use of~     toothpaste containing estrogen for eight days.~      3) To estimate the rate of decline in serum estrogen levels when the use of estrogen~     containing toothpaste is discontinued for a week.~   "
271528|NCT00029744|"~     The purpose of this study is to determine the ability of HVTN sites to recruit and retain~     people at risk for HIV infection for possible future HIV vaccine research studies. This study~     also aims to learn more about the risk behaviors of people at high risk for HIV infection.~      In order for studies to be successful, study sites must be able to recruit, enroll, retain,~     and inform groups at high risk for HIV infection. The plan for Phase III HIV vaccine trials~     will depend on the number of participants enrolled, the rate at which participants become~     HIV-infected, the length of follow-up, and the number of participants who continue and follow~     through with the entire study. At existing sites, it is necessary to evaluate the potential~     to recruit new groups. At possible expansion sites, work is necessary to establish effective~     procedures to recruit and retain participants and to identify HIV incidence rates. This study~     will accomplish those goals.~   "
271529|NCT00029731|"~     This is a study to determine if oral arginine will increase nitric oxide in sickle cell~     disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of~     arginine in the body and how the body uses nitric oxide in ACS.~   "
271530|NCT00029718|"~     This study will use transcranial magnetic stimulation (TMS) to identify interactions between~     the unaffected and affected side of the brain in stroke patients. Results from previous~     studies suggest that after a stroke, the motor cortex (part of the brain that controls~     movement) of the unaffected side of the brain might negatively influence the motor cortex of~     the affected side. TMS is a procedure that delivers brief electrical currents that stimulate~     the brain. Studies of a small number of patients have shown that TMS can cause a temporary~     decrease in activity of the motor cortex.~      Healthy normal volunteers and chronic stroke patients may be eligible for this study.~     Subjects may participate in up to four sessions of reaction time (speed of motor response)~     testing. They will perform a series of movements with the index and middle fingers of either~     the left or right hand in response to a signal from a computer monitor. The time it takes to~     do the tasks will be measured and scored. There will be rest periods during each session.~      TMS will be done each session to examine how the motor cortex affects recovery of function~     after stroke. For this procedure, an insulated wire coil is placed on the scalp. A brief~     electrical current is passed through the coil, creating a magnetic pulse that stimulates the~     brain. Depending on where the coil is placed, the stimulation may cause a muscle twitch~     (sometimes strong enough to move the limb), a feeling of movement or tingling in a limb, or~     twitching of the jaw. During stimulation, the subject may be asked to tense certain muscles~     slightly or to perform other simple actions. The electrical activity in the muscles activated~     by the stimulation will be recorded using metal electrodes taped to the skin over the~     muscles.~      Subjects will also be asked to draw a mark on a line on paper to rate their attention and~     level of fatigue, and how well they think they are executing the tasks.~      Participants will also have magnetic resonance imaging (MRI). This procedure uses a strong~     magnetic field and radio waves to provide detailed images of the brain. During the scanning,~     the subject wears earplugs to muffle loud thumping sounds that occur with electrical~     switching of the radio frequency circuits. The subject can communicate with the staff member~     performing the study at all times through an intercom system.~   "
271531|NCT00029692|"~     This study will assess the effects of ginseng and ginkgo on 1) cognitive function, 2) enzymes~     that process drugs, and 3) enzymes that may help prevent cancer.~   "
271532|NCT00029679|"~     This study will assess clinical efficacy and/or adverse effects of dietary borage oil (which~     contains gamma-linolenic acid [GLA]) and Ginkgo biloba in patients with mild persistent to~     moderate asthma.~   "
271533|NCT00029666|"~     This study will examine the effects of repetitive transcranial magnetic stimulation (rTMS) on~     Parkinson's disease symptoms. rTMS is a way of stimulating the brain that may be able to~     change the electrical activity of the nerve cells in the brain. It has been proposed as a~     treatment for brain disorders, including Parkinson's disease. In preliminary studies, some~     patients' symptoms improved; in some they worsened temporarily, and some showed no change.~      Patients between 40 and 80 years of age with moderately severe Parkinson's disease, whose~     main problem is slowness of movement and stiffness, may be eligible for this study.~      Participants will be randomly assigned to one of two treatment groups: one will receive rTMS~     to parts of the brain involved in controlling movement; the other will receive sham, or~     placebo, stimulation. Nine treatments will be given over a 4-1/2 week period. Patients will~     take their Parkinson's disease medications during the study, but will stop taking the~     medicines for 4 to 5 hours before one of the sessions.~      For rTMS, an insulated wire coil is placed on the scalp. A brief electrical current is passed~     through the coil, creating a magnetic pulse that stimulates the brain. The pulses are~     delivered in trains, or short bursts, lasting 1 second each. There will be 48 trains for a~     total of 1200 pulses per 24-minute session. The stimulation may cause muscle twitching in the~     scalp or face and may also cause small movements of the limbs.~      Just before and after each rTMS session, patients will have a neurologic examination,~     including an evaluation of walking. Their motor function tests will be recorded on videotape~     to document possible improvement and to allow physicians to rate the improvement. The~     physicians will not know which patients are receiving actual rTMS and which are receiving~     sham treatment. Ratings before the first and after the last rTMS sessions will be more~     detailed.~   "
271534|NCT00029653|"~     This study will use transcranial magnetic stimulation (TMS) to investigate how the brain~     controls movement by sending messages to the spinal cord and muscles.~      Healthy normal volunteers 21 years of age or older may participate in this study.~      They must have no medical, neurological or psychiatric illnesses nor have been taking~     medications that affect nervous system function.~      Participants will undergo transcranial magnetic stimulation. For this procedure, an insulated~     wire coil is placed on the scalp or skin. A brief electrical current is passed through the~     coil, creating a magnetic pulse that stimulates the brain. If the coil is placed over a nerve~     or area of the brain that controls muscles, it may cause a muscle twitch, possibly strong~     enough to move the limb. In other cases, the subject may have a feeling of movement or feel a~     tingling sensation in a limb. Stimulation over the muscles on the side of the head may cause~     some discomfort in that area or twitching of the jaw.~      During the stimulation, the subject may be asked to tense certain muscles slightly or perform~     other simple actions. The electrical activity of the muscles activated by the stimulation~     will be recorded using metal electrodes taped to the skin over the muscle. In most cases, the~     study takes less than 3 hours.~   "
273656|NCT00005731|"~     To develop and implement asthma-controlling educational strategies for inner city and high~     risk populations.~   "
271538|NCT00029601|"~     This study will use transcranial magnetic stimulation (TMS) to examine how the brain controls~     muscle movement in dystonia. Dystonia is a movement disorder in which involuntary muscle~     contractions cause uncontrolled twisting and repetitive movement or abnormal postures.~     Dystonia may be focal, involving just one region of the body, such as the hand, neck or face.~     Focal dystonia usually begins in adulthood. Generalized dystonia, on the other hand,~     generally begins in childhood or adolescence. Symptoms begin in one area and then become more~     widespread.~      Healthy normal volunteers and patients with focal [or generalized] dystonia [between 21 and~     65 years of age] may be eligible for this study.~      Participants will have transcranial magnetic stimulation. For this test, subjects are seated~     in a comfortable chair, with their hands placed on a pillow on their lap. An insulated wire~     coil is placed on the scalp. A brief electrical current is passed through the coil, creating~     a magnetic pulse that stimulates the brain. (This may cause muscle, hand or arm twitching if~     the coil is near the part of the brain that controls movement, or it may induce twitches or~     transient tingling in the forearm, head or face muscles.) During the stimulation, subjects~     will be asked to either keep their hand relaxed or move a certain part of the hand in~     response to a loud beep or visual cue. Metal electrodes will be taped to the skin over the~     muscle for computer recording of the electrical activity of the hand and arm muscles~     activated by the stimulation.~      There are three parts to the study, each lasting 2-3 hours and each performed on a separate~     day.~   "
271539|NCT00029588|"~     This study will examine and compare brain changes during decision-making in healthy~     adolescents and adolescents who are anxious or depressed. The findings may provide a better~     understanding of mechanisms that lead to depression or anxiety.~      Adolescents between 9 and 17 years of age and adults between 20 and 40 years of age in the~     following categories will be enrolled in this study:~        -  Healthy adults~        -  Healthy adolescents~        -  Adolescents with major depression~        -  Adolescents with anxiety disorder (generalized anxiety disorder, social phobia, or/and~          separation anxiety disorder)~      The study involves three visits, as follows:~      Visit 1~      Visit 1 consists of three parts for both child and adult participants:~        -  Part 1: Staff will meet with participants for a standard psychiatric interview, which~          will include questions about the participants feelings, experiences and behavior both~          past and present. For adolescent participants, staff will meet with the child alone, the~          parent alone, and the child and parent together.~        -  Part 2: Participants will perform a series of simple tasks involving shapes, letters,~          and numbers. They will have a medical history, physical examination and blood draw. In~          addition, adolescents will have a urine drug test.~        -  Part 3: Adults and those adolescents who will undergo magnetic resonance imaging (MRI)~          in Visit 3 will receive training to familiarize them with the procedure.~      Visit 2~        -  Adolescents will again be asked standardized questions regarding their feelings,~          experiences and behavior, and will then perform a series of simple decision-making tasks~          on a computer.~        -  Adults will undergo MRI scanning, as described below in Visit 3 for adolescents. This~          concludes the participation of adults in the study.~      Visit 3~      Adolescents will have one of the following two procedures:~      - Decision-making task using a computer. Small electrodes will be placed on the child s~     wrists, face and fingers to monitor muscle tone and skin humidity during the task.~      Or~        -  MRI, a test that uses a strong magnetic field and radio waves to show changes in brain~          function. During the scan, the participant lies on a table in a space enclosed by a~          metal cylinder (the MRI scanner). The procedure takes 60-90 minutes; subjects must lie~          still for 10-15 minutes at a time. During imaging, the subject will be asked to perform~          a decision-making task on a computer.~   "
271540|NCT00029575|"~     This study will compare four methods of imaging arteries:~        -  angiography (x-ray picture)~        -  intravascular ultrasound (ultrasound from inside the artery)~        -  magnetic resonance imaging (MRI) from outside the body~        -  MRI using an antenna to take pictures inside the arteries of the pelvis~      Standard angiography shows blockages inside the artery, but does not provide any information~     about the arterial wall itself. New ways of looking at the artery walls with MRI and~     ultrasound may provide insight into how arteries cause disease.~      Patients 21 years of age and older who require catheterization and angiography of the heart,~     kidney, or leg arteries because of atherosclerosis (narrowing of the arteries), may be~     eligible for this study. Participants will undergo MRI and intravascular ultrasound of the~     arteries immediately after their catheterization and angiography. The additional imaging will~     add from 1 to 2 hours to the angiogram procedure.~        -  Angiography: Using the sheaths already in place in the groin artery, catheters (flexible~          plastic tubes) are placed inside the arteries in order to inject a contrast dye to take~          x-ray pictures. (Patients who had an angiogram of the leg artery as part of their~          medical care will not repeat this test.)~        -  Intravascular ultrasound: An anti-clotting drug called heparin is given through a vein~          to prevent clot formation. Blood samples are taken during the test to see if more~          heparin is needed. Special wires are used to guide the catheters to the proper location~          inside the arteries. A special ultrasound catheter is advanced over one of these wires~          to the large artery that supplies blood to the legs. X-rays are used to help the~          physician place the ultrasound in the correct location to take ultrasound pictures of~          the artery wall.~        -  Magnetic resonance imaging: A special MRI catheter is advanced through the catheter in~          the groin. With the catheter in place, the patient is carried to a stretcher and moved~          into a long metal cylinder (the MRI scanner) for imaging. During the scanning, a~          contrast drug called gadolinium is injected into an arm vein to brighten the images. The~          patient is able to speak through a microphone at all times to the person taking the~          pictures.~   "
271541|NCT00029536|"~     The purpose of this investigation was to determine if cyclic adjunctive progesterone~     supplement is superior to placebo in the treatment of intractable seizures in women with and~     without catamenial epilepsy.~   "
271542|NCT00029523|"~     The purpose of this study is to find out how well an experimental drug called DepoCyt works~     for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal~     cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine).~     Cytarabine has been used for many years to treat cancer.~   "
271543|NCT00029510|"~     Asthma currently affects an estimated 15 million Americans. A number of studies have found an~     association between low dietary magnesium (Mg) intake and increased asthma incidence and~     severity of symptoms. However, clinical intervention trials are necessary to directly assess~     whether there is a true protective or preventative causal relationship between low Mg and~     asthma. In our study, we will assess the effects of 6 1/2 months of oral Mg supplements or~     placebo on clinical markers of asthma control, indirect biomarkers of inflammation, bronchial~     hyperresponsiveness, and indices of oxidative defense and damage in subjects with mild to~     moderate persistent asthma.~   "
271544|NCT00029497|"~     This study investigates the role of two active interventions and their placebo effects in~     randomized control trials. The study conducts two parallel trials of treatments for upper~     extremity pain secondary to repetitive stress disorder, including carpal tunnel syndrome. The~     active interventions are amitriptyline and acupuncture. The placebo are sham acupuncture~     device and placebo pill.~   "
271545|NCT00029484|"~     A randomized control trial testing whether a relaxation response based intervention, Tai Chi~     Chih, will affect Varicella Zoster Virus (VZV) specific immunity measures of psychological~     adaptation and health function in the older adult.~   "
271561|NCT00029211|"~     This is a randomized trial to determine if echinacea is effective in shortening the length~     and/or lessening the severity of colds in children 2 through 11 years old.~   "
271764|NCT00016783|"~     Some patients taking anti-HIV drugs as part of highly active antiretroviral therapy (HAART)~     do not show any HIV in the blood; however, some HIV will remain hidden in the body and, if~     the drugs are stopped, will return to the blood. The purpose of this study is to determine if~     short periods of stopping HAART increase the activity of CD8 and CD4 cells (cells of the~     immune system that fight infection), if repeated stopping of these drugs for longer periods~     of time and restarting them will increase effectiveness of HAART, and if the increased immune~     system activity as a result of stopping treatment leads to lower levels of HIV over time.~   "
271546|NCT00029458|"~     The purpose of this study is to evaluate the safety and effectiveness of clozapine as a~     treatment for the manic phase of bipolar disorder.~      A significant proportion of manic patients either do not respond adequately to conventional~     treatment or cannot tolerate the adverse effects associated with therapeutic doses of these~     agents. Clozapine may be a safe and effective treatment for mania. However, the efficacy of~     clozapine as an alternative therapy in treatment-resistant bipolar disorder mania has not~     been extensively researched.~      The study will be conducted in three phases. Phase 1 is a screening phase that will take~     place for 2 to 7 days. Participants will undergo a baseline positron emission tomography~     (PET) scan of the brain at the end of this period. In Phase 2, participants will be randomly~     assigned to receive either clozapine or placebo (an inactive pill) for 3 weeks. They may also~     receive lorazepam for the first 10 days of Phase 2. After 3 weeks, patients treated with~     clozapine will undergo a second PET scan. During Phase 3, participants who received placebo~     and did not improve will be offered clozapine for 3 weeks. Those who received clozapine and~     did not improve will receive other treatment for 3 weeks. At the end of Phase 3, participants~     who were treated with clozapine will have another PET scan.~   "
271547|NCT00029445|"~     This study will collect white blood cells and plasma for research on how the immune system~     controls HIV infection. The immune system of a very small group of HIV-infected patients,~     called non-progressors, has been able to control HIV for long periods without antiretroviral~     therapy. Some immune system-related genes important for this control have been identified in~     these patients. This study will examine the contribution of HLA genes B*57+, B*27+ and A*01+~     to HIV disease in progressors and long-term non-progressors. (HLA type is a genetic marker of~     the immune system.)~      HIV-infected patients 18 years of age and older with HLA types B*57+, B*27+ and/or A*01+ may~     be eligible for this study.~      Participants will undergo apheresis-a method for collecting larger quantities of certain~     blood components than can safely be collected through a simple blood draw-by one of the~     following two methods:~        -  Automated pheresis - Blood is drawn through a needle placed in an arm vein and spun in a~          machine, separating the blood components. The white cells are extracted and the red~          cells, with or without plasma (liquid part of the blood), are re-infused into the donor~          through the same needle or a needle in the other arm. An anticoagulant (medication to~          prevent blood from clotting) is usually added to the blood while in the machine to~          prevent it from clotting during processing.~        -  Manual pheresis - One unit (1 pint) of blood is drawn through a needle placed in an arm~          vein, similar to donating a pint of whole blood. The red blood cells, with or without~          plasma, are separated from the rest of the blood and re-infused to the donor through the~          same needle. Manual pheresis will be done only when a person s estimated total blood~          volume or red cell count is too low to safely permit removal of blood through a pheresis~          machine. An adult small in size or markedly anemic, for example, may fall into this~          category.~      Some of the blood collected through apheresis may be stored for future studies of HIV disease~     and immune function and for HLA testing, a genetic test of markers of the immune system. Some~     of the blood may be used to screen for different types of viral liver infections, such as~     hepatitis A, B, C, D, E, F, or G.~   "
271548|NCT00029406|"~     To conduct a prospective study of pediatric transfusion recipients to determine the risk of~     transmitting various infectious agents by blood transfusion.~   "
271549|NCT00029393|"~     To investigate a modified hematopoeitic cell transplantation (HCT) procedure for sickle cell~     disease that significantly reduces the toxicity of HCT, yet retains its therapeutic benefit.~   "
271550|NCT00029380|"~     This study will develop a national cord blood bank for siblings of patients with~     hemoglobinopathies and thalassemia.~   "
271551|NCT00029341|"~     The purpose of this study is to find out if anti-HIV drugs can be stopped without the virus~     becoming resistant to the drugs. The study will also examine how fast anti-HIV drugs leave~     the body.~      Not all HIV-infected patients may require continuous and indefinite anti-HIV therapy. There~     is evidence that stopping anti-HIV therapy will not make the virus resistant to efavirenz~     (EFV), an anti-HIV drug that remains in the body longer than most treatment drugs. In another~     study, patients were treated with EFV, zidovudine (ZDV), and lamivudine (3TC). The patients'~     virus was controlled despite the fact that some patients missed medication dosages. Many~     patients stop anti-HIV therapy because of negative effects. This study will examine the~     body's ability to fight and control virus in patients who stop therapy.~   "
271552|NCT00029328|"~     The purpose of this study is to determine the effects of etanercept, and define the toxicity,~     when administered to patients with acute non-infectious lung injury (idiopathic pneumonia~     syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell~     transplantation.~   "
271553|NCT00029315|"~     This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized~     in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to~     dissolve blood, and may allow intraventricular catheters to be more effective for a longer~     period of time.~   "
271554|NCT00029302|"~     This study will use magnetic resonance imaging (MRI) to investigate how the brain controls~     bimanual movements (movements of both hands).~      Healthy normal volunteers between 21 and 65 years of age may be eligible for this study.~      Participants will have a medical history, physical and neurological examinations, and will~     complete a questionnaire before and after testing. The study consists of two parts: 1) finger~     movement training and 2) magnetic resonance imaging, as follows:~      Part 1 - Finger movement training~      Participants will train to do three different finger movements using the index finger of both~     hands. The fingers will be taped to a device that measures their movement. The movements are:~        -  Lifting and dropping the index fingers of each hand repetitively and in synchrony~          (starting and stopping at the same time). The amplitude of finger movements is the same~          for both hands.~        -  Lifting and dropping the index fingers of each hand repetitively and in synchrony, but~          with a different amplitude for each hand.~        -  Lifting and dropping of the index finger of each hand repetitively, but each with a~          different amplitude and not in synchrony.~      Part 2 - Magnetic resonance imaging~      Participants will perform the trained movements during MRI scanning. This diagnostic~     procedure uses a magnetic field and radio waves to produce images of brain structure and~     activity. For MRI, the subject lies on a stretcher that is moved into the scanner-a cylinder~     containing a strong magnet. Earplugs are worn to protect the ears from loud thumping noises~     that occur with electrical switching of radio frequency circuits. Scanning time varies from~     20 minutes to 2 hours, with most examinations lasting 1 to 1 1/2 hours. The subject can~     communicate with the staff person conducting the test at all times during the scan.~   "
271555|NCT00029289|"~     Phase I/II double-masked, randomized, placebo-controlled, cross-over trial to determine~     effects of lutein on vision in retinitis pigmentosa, including safety and effective dosage~     assessment~   "
271556|NCT00029276|"~     During transcranial magnetic stimulation (TMS), a magnetic coil is placed on the front part~     of the head. Electric current passes through the coil in brief pulses. Magnetism from the~     current produces a separate, small electric current inside the brain, which activates brain~     cells below the coil. This treatment may result in decreased depression and improved~     Parkinson's disease symptoms.~   "
271557|NCT00029263|"~     The purpose of this study is to detect potential herb-drug interactions in volunteers.~   "
271558|NCT00029250|"~     The purpose of this study is to test the effectiveness and tolerability of garlic pills in~     lowering cholesterol and triglycerides in hyperlipidemic HIV-infected individuals who are~     being treated with highly active antiretroviral therapy (HAART).~   "
271605|NCT00027404|"~     This is a study to determine the effect of fluoxetine in the treatment of adult autism and on~     functional ability and behavior associated with autism. Evidence suggests abnormal serotonin~     function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter.~   "
271562|NCT00029198|"~     The specific aims of this study are: 1) to replicate the data that following ten days of~     massage therapy, preterm infants show greater daily weight gain and are discharged from the~     hospital earlier than the controls, thus demonstrating the cost-effectiveness of the~     intervention; 2) to test a model on two potential underlying mechanisms for weight gain~     including a) enhanced vagal activity leading to greater gastric motility, higher levels of~     insulin, IGF-1, and oxytocin and lower cortisol levels in the massage versus the control~     infants at the end of the study; and/or b) increased physical activity and its associated~     increase in heart rate oxygen consumption and temperature leading to greater weight gain.~     These pathways (vagal activity and physical activity) will be tested by path analyses.~     Determining underlying mechanisms for the massage therapy/weight gain relationship is a~     critical process required by the neonatology community for massage therapy to be adopted as a~     standard neonatal intensive care unit.~   "
271563|NCT00029185|"~     This is a compassionate-use treatment study to provide Dehydrex to patients with corneal~     erosion syndrome who have previously used Dehydrex.~   "
271564|NCT00029172|"~     The purpose of this study is to evaluate a program of education, medicine, and monitoring for~     the treatment of depression after a stroke.~   "
271565|NCT00029159|"~     The purposes of this study are to learn whether treatment with an androgen type hormone will~     improve the visual-spatial problems associated with Turner syndrome, and to evaluate the~     effect growth hormone, with and without androgen, has on growth.~   "
271566|NCT00029146|"~     The purpose of this study is to determine if extracranial-intracranial bypass surgery when~     added to best medical therapy can reduce the subsequent risk of ipsilateral stroke in~     high-risk patients with recently symptomatic carotid occlusion and increased cerebral oxygen~     extraction fraction measured by positron emission tomography (PET).~   "
271567|NCT00029133|"~     This is a large multi-center, prospective, randomized trial designed to determine whether~     mild intraoperative hypothermia results in improved neurological outcome in patients with an~     acute subarachnoid hemorrhage (SAH) who are undergoing an open craniotomy to clip their~     aneurysms.~   "
271568|NCT00028431|"~     This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail~     composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's~     adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV~     melanoma.~   "
271569|NCT00028418|"~     This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of~     clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias.~     Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the~     better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against~     lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less~     toxic than similar drugs.~   "
271570|NCT00028405|"~     This multi-center photodynamic therapy study plans to treat patients with large tumors in any~     superficial location, sarcoma, tumors of oral/oro-pharyngeal cavity, tumors with extensive~     pelvic involvement, or liver metastasis. The treatment is limited to patients that have~     failed to respond to currently approved methods of treatment. The study involves a single,~     intravenous administration of an investigational drug, LS11 (previously studied in~     approximately 80 cancer patients) and the placement of a novel, flexible light delivery~     catheter inside the tumor by a minor surgical procedure. The activation of LS11 by the light~     delivery catheter over a period of 1-24 hrs may result in destruction of tumor tissue.~   "
271571|NCT00029120|"~     The purpose of this study is to examine how a part of the brain called the hippocampus~     contributes to memory changes that occur with aging and Alzheimer's disease (AD).~      Memory problems are the most important early symptoms of AD. The hippocampal region of the~     brain may be responsible for many age- and AD-related memory disorders. This study will use~     magnetic resonance imaging (MRI) scans to examine the structure, chemical composition, and~     function of the hippocampus in participants with AD, participants with mild memory problems,~     participants who are healthy but are at risk for AD, and healthy volunteers.~      Participants in this study will undergo MRI scans of the brain. During the MRI, participants~     will perform memory tests to demonstrate hippocampal functioning.~   "
271572|NCT00029107|"~     The purpose of this study is to assess the efficacy of Rituximab (anti-CD20) in the treatment~     of patients with hepatitis C associated cryoglobulinemic vasculitis (HCV-CV) who have failed~     or are intolerant to interferon-alpha/ribavirin therapy. Up to 75 patients may be screened to~     enroll 34 adult patients with active HCV-CV in this randomized, non-blinded phase I/II trial.~     Patients will be randomized to receive either Rituximab 375 mg/M(2) on days 1, 8, 15 and 22~     beginning at the time of enrollment or standard therapy. Patients in both groups will be~     maintained on stable doses of any immunosuppressive therapies that they were receiving at the~     time of enrollment. Response to Rituximab will be assessed by clinical and laboratory~     parameters.~      Although the cause of cryoglobulinemic vasculitis is not known, a critical component is the~     presence of cryoglobulins-abnormal proteins that white blood cells called B lymphocytes~     produce in response to the chronic hepatitis C infection. Rituximab decreases the number of B~     cells. The Food and Drug Administration approved Rituximab in 1997 for the treatment of~     B-cell non-Hodgkin's lymphoma.~      Patients between 18 and 75 years of age with hepatitis C and signs and symptoms of~     cryoglobulinemic vasculitis may be eligible for this study. They must have failed, or been~     unable to tolerate, treatment with IFN-a and ribavirin. Candidates will be screened with a~     history and physical examination, electrocardiogram (ECG), blood and urine tests, 24-hour~     urine collection and chest X-ray, if clinically indicated.~      Participants will be randomly assigned to receive Rituximab upon entering the study or 6~     months after entering the study. Those whose treatment is delayed 6 months will be followed~     once a month at NIH for disease evaluation and blood tests during that time.~      Patients will be given Rituximab intravenously (through a vein) once a week for 4 weeks. For~     the first dose, patients will be admitted to the hospital for at least 24 hours after the~     infusion for monitoring. Subsequent infusions will be given on an inpatient or outpatient~     basis, depending on how the infusion is tolerated. The day before each infusion they will~     have a history and physical examination, blood work, and other tests, such as X-rays, as~     clinically indicated.~      After the four infusions, patients will be followed for drug side effects and response to~     treatment. They will have blood tests every week for 4 weeks and will then return to NIH for~     1 day every month for 12 months for a physical examination, blood tests, and X-rays, if~     medically indicated. Visits may be more frequent, if necessary, and patients may be asked to~     stay longer than a day if test findings requ...~   "
271606|NCT00027391|"~     This is a study to determine whether albuterol or oxandrolone, alone or in combination, are~     able to increase strength and muscle mass in patients with FSHD. It also will determine if~     albuterol given in pulsed fashion will have more effect than when given continuously.~   "
271607|NCT00027378|"~     This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment~     of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals~     will receive treatment for 12 weeks with a followup phase lasting 9 months.~   "
272193|NCT00002154|"~     The purpose of this study is to see if it is safe and effective to give thioctic acid and~     deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who~     have mild to moderate dementia (a decline in their mental abilities).~   "
271573|NCT00029068|"~     This study will use transcranial magnetic stimulation (TMS) to study the function of the~     cerebral cortex (outer layer of the brain) in people with obsessive compulsive disorder (OCD)~     and related disorders. A non-invasive procedure, TMS activates areas of the brain with~     magnetic pulses that travel through the scalp and head and cause small electrical currents in~     the brain.~      People 18 years of age and older with OCD and disorders that may be related-tic disorders,~     such as Tourette's syndrome, focal dystonia (localized muscle cramps), body dysmorphic~     disorder (hypersensitivity to changes in appearance), eating disorders, such as anorexia~     nervosa, trichotillomania (compulsive hair-pulling)-may be eligible for this study. Healthy~     normal volunteers will also be enrolled. Candidates will be screened by telephone interview.~      Participants will undergo TMS. For this procedure, an insulated wire coil is placed on the~     subject's head. A brief electrical current passes through the coil, creating a magnetic pulse~     that travels through the scalp and skull and causes small electrical currents in the outer~     part of the brain. The stimulation may cause muscle, hand or arm twitching, or may affect~     movement or reflexes. During the stimulation, the subject may be asked to tense certain~     muscles slightly or perform other simple actions. The electrical activity of muscles during~     stimulation is recorded with a computer or other recording device, using electrodes attached~     to the skin with tape.~      Subjects will receive fewer than 500 magnetic pulses, and the study will take less than 3~     hours. Participants may repeat the procedure on several occasions, if they agree.~   "
271574|NCT00029042|"~     This study will determine whether a stepwise increase of the drug infliximab (Remicade®~     (Registered Trademark)) controls juvenile rheumatoid arthritis more effectively than a fixed~     dose. It will look at the safety and effectiveness of increasing the dose to a maximum of~     15mg/kg body weight per dose, examining the drug's effect on bone and cartilage, and whether~     it can improve abnormal growth, metabolism and hormones. Infliximab is approved for treating~     adults with rheumatoid arthritis and Crohn's disease.~      Children between 4 and 17 years of age with active juvenile rheumatoid arthritis who do not~     respond adequately to standard therapy may be eligible for this study.~      Participants will receive nine infusions of infliximab during this 62-week study. The drug is~     given intravenously (IV, into a vein) over 2 hours. The first three infusions will be at a~     dose of 5 mg/kg of body weight. Children who improve on this regimen will receive another 6~     infusions at the same dose. Children who do not significantly improve on 5 mg/kg at the end~     of 6 weeks (the third infusion) may continue with phase 2 of the study, in which they will be~     randomly assigned to receive either: 1) 6 additional doses of the drug at 5 mg/kg per dose,~     or 2) a gradually increased dose to a maximum of 15 mg/kg. In addition, all children will~     continue to take methotrexate at the same dose as when they entered the study.~      Participants will visit the NIH Clinical Center 12 times (about every 8 weeks) during the~     study for the following tests and procedures:~        -  History and physical examination, including a complete joint exam~        -  Puberty assessment - breast development in girls, testicle size in boys, and pubic hair~        -  Height and weight measurements~      Children will have imaging studies (x-rays, MRI and Dexa scan) at the beginning and end of~     the study and will collect a 24-hour urine sample before each infliximab infusion.~      Patients may elect to have an endocrine evaluation. This involves Clinical Center~     hospitalizations for 1-1/2 days on visits 1, 4 and 12. Small amounts of blood will be drawn~     every 20 minutes (through an indwelling catheter to avoid multiple needle sticks) for 8 hours~     while the child sleeps. The blood will be examined for the normal rhythm of growth hormone~     and other substances in the body and how they are affected by arthritis.~      Participants will complete a questionnaire once a year for 2 years to provide information on~     their health status and any problems that might be related to the study drug.~   "
271575|NCT00028379|"~     Recent studies have demonstrated that electrical stimulation delivered over the skin~     increases the muscle strength as measured by a dynamometer in chronic stroke patients. We~     recently also found out that such stimulation enhances the ability of healthy brains to learn~     faster, enhancing the beneficial effects of the motor training.~      The purpose of this study is to find out if this stimulation can enhance the ability of~     stroke patients to experience plastic changes in the brain. It may aid in the development of~     new strategies for rehabilitation after brain injury in the future.~      A clinical and neurological exam will be administered. Each patient will participate in three~     different sessions separated by at least 48 hours: a 2-hour peripheral nerve stimulation to~     the weak hand, a 2-hour peripheral nerve stimulation to the leg, and no stimulation. The~     sessions will be randomly ordered. A magnetic resonance imaging scan of the brain will be~     done as well.~      Nerve stimulation will be done by transcranial magnetic stimulation (TMS). In TMS, the head~     is immobilized within a frame. An insulated coil wire is placed on the scalp and brief~     electrical current passed through it. Participants may be asked to perform movements, do~     simple tasks, or simply tense muscles. Electrical activity of the muscles will be recorded~     with a computer. Some experiments may be recorded on videotape.~      Participants must be stroke patients who have recovered to the point of being able to make~     thumb movements, and the stroke must have occurred more than 6 months ago.~   "
271576|NCT00028366|"~     Ritonavir (RTV) is a protease inhibitor (PI) commonly used to increase drug levels of other~     PIs in HIV drug treatment. The purpose of this study is to compare a combination of drugs~     which includes RTV and 2 protease inhibitors (PIs) with 2 combinations that include RTV and~     another PI. This study also will compare the effectiveness, safety, tolerability, and drug~     levels in the blood of these anti-HIV drug combinations.~   "
271577|NCT00028353|"~     If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or~     III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate~     biopsy, you may be eligible for this study. This is a study of an investigational medication~     that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is~     currently enrolling up to 500 men at approximately 60 locations in the United States.~   "
271578|NCT00028340|"~     Background:~      Breast cancer is the most common malignancy in women, occurring in over 230,000 women~     annually in the United States.~      The vast majority of breast cancers originate in the single layer of epithelial cells that~     line the ductal/lobular system of the breast milk ducts. The premalignant changes which occur~     in the transformed epithelium are not well understood, however several cytologic or~     histologic changes have been identified which are associated with an increased risk for~     breast cancer, including ductal or lobular hyperplasia, hyperplasia with atypia, and lobular~     or ductal carcinoma in situ.~      The identification of cytological or histological abnormalities in breast epithelial cells is~     an important component of risk assessment.~      Objectives:~      The primary objectives are:~      To determine the incidence and nature of cytologic changes in ductal epithelial cells from~     the high risk breast, in specimens collected by breast duct lavage, and to determine if these~     cytologic findings are different from those of normal women not at increased risk for breast~      cancer.~      To characterize by breast duct endoscopy, high risk breast ductal epithelium and~     architecture, and correlate these findings with the cytologic findings from above.~      To determine what is the global gene expression pattern of high risk breast epithelial cells~     from the high risk breast, and does this differ from that of breast epithelial cells from~     normal women not at increased risk for breast cancer. The gene expression profile will be~      determined by cDNA microarray and validated by RT-PCR.~      Eligibility:~      Eligibility for high risk individuals will include:~        -  Women of any age with a unilateral invasive or noninvasive (DCIS) breast cancer of~          epithelial origin.~        -  Women without breast cancer, but with a Gail Index greater than 1.67%, or a cumulative~          lifetime risk greater than or equal to double the age- and race-matched general~          population risk.~        -  Women known to be BRCA1/2 or other hereditary genes mutation carriers.~        -  Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal~          hyperplasia, or lobular carcinoma in situ.~        -  Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the~          absence of menstrual periods for at least 12 months.~        -  Postmenopausal women who have previously undergone a hysterectomy without oophorectomy~          must have a serum FSH level of >40 IU/ml, and a serum estradiol level of less than40~          pg/ml to document postmenopausal status.~      Eligibility for normal volunteers will include:~        -  Women who are premenopausal or postmenopausal with a Gail model risk index less than~          1.67%, and without a cumulative lifetime risk greater than or equal to double the age-~          and racematched general population risk.~        -  Women who have previously undergone a hysterectomy without oophorectomy must have a~          serum FSH level of >40 IU/ml, and a serum estradiol level of less than 40 pg/ml to~          document postmenopausal status.~        -  Both breasts must be free of any suspicious areas by physical examination and, for women~          over 30 years of age by mammogram. There must be no past history of atypical~          hyperplasia, invasive or in situ carcinoma.~      Both groups must have acceptable WBC and platelet counts.~      Design:~      Breast ductal epithelial cells will be collected by breast duct lavage from a.) the breast in~     women at increased risk for breast cancer, and b.) the breast of female normal volunteers who~     are not at increased risk for breast cancer.~      Ductal epithelial cell specimens will be analyzed cytologically for the presence of~     hyperplasia, atypia, or in situ changes.~      Breast duct endoscopy will be performed in breast cancer patients and in normal volunteers~     with cytologic atypia on ductal lavage to determine ductal architectural changes associated~     with increased risk for breast cancer, and to provide correlation with cytologic atypia.~      The gene expression profile of normal and high risk ductal epithelial cells will be studied~     by cDNA-microarray to determine changes in gene expression associated with increased risk for~     breast cancer.~      Additional molecular profiling experiments which will be performed as lavage cells are~     available include DNA whole exome sequencing, Comparative Genomic Hybridization (CGH),~     proteomic tissue lysate arrays, and identification of mammary stem cells.~      A total of 104 high risk subjects and 80 normal volunteers will be studied, divided~     approximately evenly between premenopausal and postmenopausal women.~   "
271579|NCT00028327|"~     Many HIV infected patients admitted to the intensive care area (ICA) have never taken~     anti-HIV drugs. The purpose of this study is to learn whether starting anti-HIV drugs while~     patients are in an ICA will help them to survive and get better faster. This study will also~     evaluate patients who, though not in an ICA, have been admitted to the hospital for serious~     illnesses or infections.~   "
271580|NCT00028314|"~     The goals of this study are to find out if fat wasting and weight loss in the arms and legs~     of HIV patients taking highly active antiretroviral therapy (HAART) are caused by~     nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and if wasting can be reversed~     if the NRTI is stopped and replaced with other anti-HIV drugs.~   "
271581|NCT00028301|"~     This study will compare 2 treatments in the way they affect cholesterol levels and the amount~     of HIV in the blood.~   "
271582|NCT00028288|"~     The purpose of the study is to evaluate an investigational medication to treat chronic~     persistent asthma. The research is being conducted at up to 22 clinical research sites in the~     US and is open to both men and women ages 18 to 70 years old. Participants in the study will~     have a number of visits to a research site over a 10-month period. All study-related care and~     medication is provided to qualified participants at no cost: this includes all visits,~     examinations and laboratory work.~   "
271583|NCT00028275|"~     This study will test whether gamma interferon is effective in treating chronic hepatitis C~     infection-a long-lasting viral infection affecting the liver. One-third of patients with~     hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or~     liver cancer. The current treatment for hepatitis C infection is pegylated alpha interferon~     (peginterferon) plus ribavirin; however, this treatment is successful in only about half of~     patients. Gamma interferon works similarly to alpha interferon, but through different~     pathways, and therefore might be helpful in patients who do not respond to alpha interferon.~      Patients 18 years of age and older with chronic hepatitis C infection, genotype 1, who did~     not respond to alpha interferon and ribavirin therapy may be eligible for this study.~     (Genotype 1 is a strain of hepatitis C virus that has a lower treatment success rate.)~      Potential participants will be admitted to the NIH Clinical Center for 2 to 3 days for a~     medical evaluation to determine eligibility for the study and, if enrolled, to begin gamma~     interferon therapy. Screening will include a medical history and physical examination, blood~     and urine tests, and possibly chest X-ray, abdominal ultrasound, and psychiatric evaluation.~      Participants will receive injections of gamma interferon under the skin 3 times a week for 4~     weeks (a total of 12 injections). They will be randomly assigned to receive either 100 or 200~     micrograms of drug per injection. Blood will be drawn just before the first injection and~     then 6, 12, 24 and 48 hours later to monitor changes in the levels of hepatitis C virus and~     immune responses to treatment. The amount and rapidity of decrease in virus will be compared~     with what occurs with alpha interferon treatment to define the relative effectiveness of~     gamma interferon. (Patients may leave the hospital at any time after the first day, but must~     return in time for the final blood test.)~      Patients will be seen in the clinic each week during treatment to report symptoms and drug~     side effects and to have blood drawn for routine tests and viral levels. After the 4-week~     treatment is completed, patients will return for follow-up visits at weeks 6 and 8 for~     routine blood tests.~   "
271584|NCT00028262|"~     This study will examine the effectiveness of a drug called Cystagon in treating infantile~     neuronal ceroid lipofuscinosis (INCL), a progressive neurological disease affecting children.~     At around 11 to 13 months of age, patients develop slowed head growth, mild brain atrophy~     (wasting), electroencephalographic (EEG) changes and retinal deterioration, with symptoms~     worsening over time. The disease results from an enzyme deficiency that causes fatty~     compounds called ceroid to accumulate in cells. In laboratory experiments, Cystagon has~     helped remove ceroid from cells of patients with INCL.~      Children with INCL between 6 months and 3 years of age may be eligible for this study.~     Participants take Cystagon daily by mouth every 6 hours. They are admitted to the NIH~     Clinical Center for a 4- to 5-day period every 6 months for the following tests and~     evaluations:~        -  Review of medical history, including a detailed record of seizures, physical~          examination, blood tests and clinical photographs. For the initial baseline studies,~          examinations may also be scheduled with pediatric neurology, ophthalmology and~          anesthesia services.~        -  Magnetic resonance imaging (MRI) of the brain MRI uses a powerful magnet, radio waves,~          and computers to provide detailed images of the brain without the use of X-rays. The~          patient lies on a table that slides inside a donut-shaped machine containing a magnetic~          field. The child requires general anesthesia for the procedure.~        -  Electroretinogram (ERG) measures the function of the retina, the light-sensitive tissue~          in the back of the eye. To record the flash ERG, a special contact lens is placed on the~          eye s surface and the eye is stimulated with flashes of light. Infants and very young~          children require general anesthesia for the procedure.~        -  Visual evoked potential (VEP) measures the function of the visual pathway from the eye~          to the brain. To record the VEP, five electrodes are placed on the scalp and the eye is~          stimulated with flashes of light. Infants and very young children must be anesthetized~          for the procedure.~        -  Electroencephalogram (EEG) measures brain electrical activity, using electrodes placed~          on the scalp. The test is useful in defining seizures. The child may need to be sedated~          to keep still during the test.~        -  Skin biopsy A small piece of skin is removed (usually from the upper arm or shoulder)~          under local anesthetic to grow cells in the laboratory. This procedure is done at the~          start of the study and is repeated after 1 year if therapy results are promising.~      Children s condition may improve, stabilize or worsen during this study. Life may be~     prolonged without significant improvement in quality. The information gained from the study~     may help scientists develop more potent drugs to treat INCL.~   "
271585|NCT00028249|"~     This study will investigate the most effective approach for managing pain and providing~     palliative care (lessening of pain or symptoms).~      Patients with advanced cancer who are enrolled in a National Cancer Institute (NCI) protocol~     and will undergo major surgery as part of their treatment may be eligible for this study.~      Participants will be randomly assigned to pain management provided by either 1) their~     attending physician or 2) the Clinical Center's Pain and Palliative Care Service. Patients in~     the first group may be reassigned to the Pain and Palliative Care Service at any time during~     the study.~      Participants will be interviewed every 3 months for as long as 1 year about their pain, its~     effect on several areas of their lives, changes in their needs, and how well they think their~     pain is being managed.. As the patients progress through the NCI study, they will meet~     regularly and as often as needed with either their attending physician or the Pain and~     Palliative Care team. Each interview will last about 20 to 30 minutes. With the patient's~     permission, the interviews will be tape recorded.~   "
271586|NCT00028236|"~     This is a clinical trial of gene therapy for X-linked severe combined immunodeficiency~     (XSCID), a genetic disease caused by defects in a protein called the common gamma chain,~     which is normally on the surface of immune cells called lymphocytes. XSCID patients cannot~     make T lymphocytes, and their B lymphocytes fail to make essential antibodies for fighting~     infections. Without T and B lymphocytes patients develop fatal infections in infancy unless~     they are rescued by a bone marrow transplant from a healthy donor. However, even transplanted~     patients may achieve only partial immune recovery and still suffer from many infections,~     auto-immunity and/or and poor growth. A recent, successful trial in France used gene therapy~     instead of bone marrow transplantation for infants with XSCID. This experience indicates that~     gene therapy can provide clinical benefit to XSCID patients. We will enroll eight older XSCID~     patients (1.5-20 years-old), who have previously received at least one bone marrow~     transplant, but still have poor T and B lymphocyte function that compromises their quality of~     life. Before enrollment, these subjects will have had some of their own blood-forming stem~     cells harvested and frozen in a blood bank. These cells have a defective gene, but a correct~     copy of the gene will be inserted while the cells are grown in sterile conditions outside the~     patient's body. To do this, the cells will be unfrozen and exposed for four days in a row to~     growth factors and particles of a retrovirus we have constructed and tested called GALV~     MFGS-gc. Retrovirus particles will attach to the patient cells and introduce a correct copy~     of the common gamma chain gene into cells capable of growing into all types of blood cells,~     including T and B lymphocytes. XSCID patients who are enrolled in the study will receive a~     single dose of their own cells that have been modified by the GALV MFGS-gc treatment and also~     will be given another drug called palifermin to help prevent side effects from the~     chemotherapy and possibly try to improve the development of the T cells. After this, the~     patients will be monitored to find out if the treatment is safe and to see if their immune~     function improves. Study endpoints are (1) efficient and safe clinical-scale transduction of~     HSC from post-BMT XSCID subjects; (2) administration of a nonmyeloablative conditioning~     regimen in older patients to improve engraftment; (3) administration of a transduced HSC to~     eight subjects; (4) administration of KGF to improve thymic function post transplant to~     improve T cell development; and (5) appropriate follow-up of the treated subjects to monitor~     vector sequence distribution, gc expression in hematopoietic lineages, and lymphoctye numbers~     and function as well as general health and immune status.~   "
271587|NCT00028210|"~     This study will examine whether tactile (touch) abilities at the lip are more acute in people~     with upper limb amputation compared with healthy normal volunteers. People with an amputated~     upper limb have an expanded brain representation of the lip that may correlate with~     heightened tactile spatial acuity.~      Normal volunteers will be recruited for this study. Candidates will be screened with physical~     and neurological examinations. (Amputee volunteers will be studied at the amputee clinic at~     the University of Tubingen, Germany.)~      Participants will sit comfortably in a chair, wearing a blindfold, during the following~     experiments:~        -  Plastic domes with grooves are placed on parts of the lower lip on either side for a few~          seconds. The volunteer is then asked to identify the direction of the grooves relative~          to the long axis of the lip.~        -  The participant's arm is placed in a cast and the index finger is immobilized. The same~          test done on the lip is repeated on the distal part of the index finger.~      Each part of the test lasts about 20 minutes, and the entire experiment takes about 2 hours.~   "
272194|NCT00002153|"~     To evaluate topical A-007 in patients with advanced malignancies including Kaposi's sarcoma~     and lymphoproliferative disorders.~   "
271588|NCT00028197|"~     This study will use magnetic resonance imaging (MRI) to investigate how the brain controls~     voluntary movements triggered by an external stimulus or self-initiated.~      Registered HCMS healthy normal volunteers may participate. They will complete a questionnaire~     and will have a medical history and brief physical examination.~      The study consists of two parts: 1) body movement training and 2) magnetic resonance imaging,~     as follows:~      Part 1 - Body movement training~      Participants will train to do three different body movements involving the hands and feet.~     The movements will either be self-initiated or in response to a stimulus, such as a visual or~     auditory trigger.~      Part 2 - Magnetic resonance imaging~      Participants will do one or more of the trained movements, with or without a triggering~     stimulus, during MRI scanning. MRI is a diagnostic procedure that uses a magnetic field and~     radio waves to produce images of brain structure and activity. For the procedure, the subject~     lies on a stretcher that is moved into the scanner-a cylinder containing a strong magnet.~     Earplugs are worn to protect the ears from loud thumping noises that occur with electrical~     switching of radio frequency circuits. Scanning time varies from 20 minutes to 2 hours, with~     most examinations lasting 1 to 1-1/2 hours. The subject can communicate with the staff person~     conducting the test at all times during the scan. A device compatible with magnetic resonance~     will be used to record the participant's body movements. The participant may be asked to push~     buttons of the device during the tasks.~   "
271589|NCT00028184|"~     The purpose of this study is to better understand the role of the motor part of the brain in~     the recovery of motor function after stroke. The motor deficits that follow a stroke are~     compensated for over several months. It has been proposed that the ipsilateral motor cortex~     mediates these recovery processes. The results of this study will provide fundamental~     information on the role of ipsilateral M1 in recovery of motor function after chronic stroke.~      A general patient evaluation will determine the location of the lesion site and assess the~     degree of impairment in motor and global cognitive functioning. An assessment of motor~     function will also be performed. Patients will be divided into two groups: well and poorly~     recovered. An MRI (magnetic resonance imaging) scan may also be done if one has not been~     performed in the past 6 months.~      Two main procedures will be performed: transcranial magnetic stimulation (TMS) and test of~     motor performance. In the first procedure, a metal coil surrounded by a plastic mold will be~     placed on the head and electrical current will be pulsed through it. The electrical muscle~     activity will be recorded through these electrodes with a computer. The second procedure~     involves a reaction time test. The task will consist of reacting to a visual stimulus by~     performing a voluntary movement. TMS pulses will be given before each movement. This is done~     to determine whether this type of stimulation interferes with reaction time, which would~     indicated that it interferes with the brain centers executing the reaction to the visual~     Go-signal.~      Patients with single ischemic hemispheric lesions at least 12 months after the stroke who~     initially had a severe paralysis of the arm will be recruited for the study. Healthy normal~     volunteers will also be included in the study. A special effort will be made to increase the~     participation of women and diverse racial groups.~   "
271590|NCT00028171|"~     Tacrolimus is a medication given to transplant patients to help prevent rejection. The~     purpose of this study is to see if tacrolimus can be taken once a day instead of twice a day~     in kidney transplant patients.~      Transplant patients are required to take several medications to prevent rejection and to~     treat complications after their transplantation. Because of the complicated dosing schedule,~     it can be difficult for patients to follow their medication schedule. Taking fewer~     medications less frequently may help transplant patients to better manage their drug therapy.~      Tacrolimus is better absorbed in the body if it is taken in the morning than if it is taken~     in the evening. This suggests that tacrolimus can be taken once every morning instead of~     twice daily in order to produce appropriate drug exposure to prevent organ rejection without~     increased side effects.~   "
271591|NCT00028158|"~     This clinical trial will study the safety and effectiveness of an engineered herpes virus,~     G207, administered directly into the brain of patients with recurrent brain cancer. G207 has~     been modified from the herpes virus that causes cold sores (called herpes simplex virus type~     1 or HSV-1). G207 has been designed so that it should kill tumor cells, but not harm normal~     brain cells. G207 has been shown to be safe in animal testing completed to date and in~     previous studies in patients with brain tumors.~      This is a phase Ib/II study. In the phase Ib portion of the study, patients will receive G207~     at a dose that is higher than tested in previous human studies. Patients will initially~     receive 15% of the assigned dose injected directly into the brain tumor. Approximately two~     days later, as much of the tumor as possible will be surgically removed, and more G207 will~     be injected into the brain tumor bed. Patients will be monitored, and medical tests will be~     done at specific study timepoints.~      The phase II portion will begin only if there are no safety concerns in the phase Ib portion.~     The goals of the phase II portion of the study are to determine the safety of G207 and to~     study patient survival at six months after G207 dosing. In the phase II portion of the study,~     patients will receive a single dose of G207 at the highest dose determined to be safe in the~     phase Ib portion of the study. The tumor will be removed, and G207 will be injected into any~     remaining tumor tissue in the brain tumor bed. Patients will be closely monitored, medical~     tests will be performed at specific study visits, and survival will be evaluated.~   "
271592|NCT00028145|"~     The purpose of this study is to collect and study clinical and laboratory information about a~     pregnant or new mother and her medical care that will increase our knowledge of the best care~     for HIV-infected pregnant women and their children.~      The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S.~     Public Health Service guidelines recommend that HIV-infected pregnant women be treated with~     anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her~     infant have not been fully examined. This study will monitor the health of women and their~     infants while they receive anti-HIV therapy. Also, this study will provide information that~     may be used for future studies.~   "
271593|NCT00028132|"~     The purpose of this study is to evaluate the PMPA gel, which kills microbes, in HIV-infected~     and HIV-uninfected women.~      The majority of new HIV infections occur through heterosexual contact. A product that stops~     or slows the replication of HIV during sexual contact is needed. At present, there are no~     products that are completely effective. PMPA gel, also known as tenofovir, is an anti-microbe~     agent that may fight against sexual transmission of HIV and other sexually transmitted~     diseases (STDs). It is applied to the vagina and gives women the ability to control their~     disease-prevention activity.~   "
271608|NCT00027365|"~     The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are~     safe and tolerable in humans and to see how the immune system responds to the vaccines.~      There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS~     is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to~     prevent HIV disease is the best way to try to deal with this situation. Several vaccine~     products have been tested, but only 2 are still in trial. There is a need for a new product.~   "
271594|NCT00028119|"~     The purpose of this study is to ensure that the HIV Prevention Trials Unit (HPTU) in Pune~     will be able to enroll and retain participants for 2 upcoming HPTN clinical trials.~     Specifically, this study seeks to find the rate of HIV infection and follow-up among a group~     of high-risk, HIV-negative non-sexworker women in Pune, as well as among HIV-discordant~     couples (couples where 1 partner is HIV-infected and the other is not).~      Phase III studies of HIV prevention require the participation of a large number of people at~     high risk for HIV infection. It is also important that these participants continue and follow~     through with the study through the extended period of follow-up. A measurement of HIV~     incidence and retention rate among high-risk women and HIV-discordant couples is necessary~     for upcoming HPTN trials. Taken together with the need for estimates of HIV incidence and the~     need for data to ensure high retention rates, this protocol is important for the HPTN~     generally and for HPTU in Pune in particular.~   "
271595|NCT00028106|"~     This study will evaluate the effectiveness of 131MIBG in treating malignant pheochromocytoma~     and whether sensitization medications improve the response to treatment. Pheochromocytoma is~     a rare type of tumor that usually occurs in the adrenal glands. The tumor cells release~     chemicals like adrenaline that can cause large increases in blood pressure and pulse rate,~     with serious health consequences. Tumor in the adrenal glands usually can be removed~     surgically, but if the pheochromocytoma is malignant-i.e., has spread to many sites in the~     body-or is located in places where surgery is difficult or impossible, no satisfactory~     treatment is available. 131MIBG is a combination of an adrenaline-like chemical and a~     radioactive form of iodine. The 131MIBG attaches to the tumor cells and the high~     concentration of radioactive iodine kills them. Previous studies using 131MIBG to treat~     pheochromocytoma had a 36% response rate in terms of complete or partial improvement. This~     study will examine whether adding other sensitization medications to the 131MIBG treatment~     regimen will enhance its effectiveness in reducing the size and number of tumors.~      Patients 18 years of age and older with malignant or inoperable pheochromocytoma may be~     eligible for this 18-month study. Candidates will be screened with various tests and~     procedures, which may include a medical history, physical examination, blood and urine tests,~     lung function studies, electrocardiogram, echocardiogram, computed tomography (CT), magnetic~     resonance imaging (MRI), positron emission tomography (PET), and bone scans and other scans~     using radioactive MIBG and octreotide.~      Participants will be randomly assigned to one of two treatment groups: 1) 131MIBG plus~     sensitization medications, or 2) 131MIBG alone. All patients will be hospitalized 3 to 5 days~     for each 131MIBG treatment. The drug will be infused through a vein (intravenously, or I.V.)~     over 10 to 30 minutes. Patients will receive up to 3 treatments, separated by at least 3~     months. All patients will also take potassium to protect the thyroid gland from radioactive~     iodine generated by the 131MIBG. The potassium is taken twice a day for 30 days, beginning~     the day before the 131MIBG treatment. Patients in the sensitization group will receive the~     following additional drugs for sensitization: methylprednisolone, intravenously a few minutes~     before 131MIBG treatment; Roaccutan, by mouth (capsules) twice a day for 6 weeks before~     treatment; Demser, by mouth 3 times a week for 1 week before treatment, and Carbidopa, by~     mouth every 6 hours for 4 days before treatment.~      After each treatment, patients will have a clinical evaluation and periodic blood tests to~     check for adverse side effects of radiotherapy. Follow-up visits at NIH will be scheduled at~     12 and 18 months after the first 131MIBG treatment for clinical, laboratory and imaging~     tests. Patients who had tumors in the lungs before treatment will have lung function tests 1,~     3, and 6 months after each treatment. CT, MRI 131MIBG, and PET scanning will be done 1 week~     before each treatment.~      Patients who have tumors that have grown by more than 25% and none that have shrunk by more~     than 50% or who have developed one or more new tumors while on 131MIBG treatment will be~     taken off the study.~   "
271596|NCT00028093|"~     This study will examine the effectiveness of pegylated interferon, or peginterferon (a~     long-acting form of alpha interferon) plus ribavirin in treating hepatitis C (genotype 1)~     infection with and without kidney disease.~   "
271597|NCT00028080|"~     This study is designed to establish a population of patients with Lyme disease for~     evaluation, treatment and follow-up to learn more about the infection.~      Patients with active Lyme disease may be eligible for this study.~      Participants will have a medical history and physical examination and diagnostic evaluations~     as appropriate to their individual condition. Laboratory tests may include routing blood and~     urine tests, X-rays, or other imaging studies, body fluid or tissue cultures, skin biopsy and~     tests for allergic or immune responses. Treatment will include only medications approved by~     the Food and Drug Administration, given according to accepted dose schedules and ways of~     taking the medicines. All diagnostic tests and treatments will be according to standard~     medical practice for the disease. No experimental procedures will be offered under this~     protocol.~      Patients will be followed as needed for evaluation and treatment of their condition. In~     general, they will be asked to return at the end of therapy, then 3, 6 and 12 months later,~     and then every 6 to 12 months. More frequent visits may be required or less frequent visits~     may be allowed, depending on the individual s condition.~      Participants may be asked to undergo the following additional procedures for research~     purposes:~        -  Extra blood draws to study Lyme disease and other inflammatory conditions. Blood will be~          drawn from arm veins. The total amount drawn during any 6-week period will not exceed~          450 cc (30 tablespoons) for adults and 7 cc (1/2 tablespoon) per kilogram (2.2 pounds)~          of body weight for children under 18 years of age.~        -  Leukapheresis to collect large numbers of white blood cells. Whole blood is collected~          through a needle in an arm vein, similar to donating blood. The blood circulates through~          a machine that separates it into its components, and the white cells are removed. The~          rest of the blood is returned to the body through the same needle. Only adults 18 years~          of age and older will be asked to undergo leukapheresis.~   "
271598|NCT00028067|"~     The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in~     their ability to reduce viral load.~   "
271599|NCT00027482|"~     This study will explore the responses of the immune system to infection with HIV and other~     pathogens and the changes in these responses over time.~      Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible~     for this study.~      Prior to enrollment and yearly thereafter, vital signs, height and weight will be recorded. A~     medical history will be obtained if relevant to the laboratory research for which the sample~     will be used. A more extensive history and physical exam is not required but may be performed~     if deemed necessary by the VRC clinician. A complete blood count will be performed on the day~     of enrollment and yearly thereafter. Samples will be collected in the following manner:~      Blood will be drawn from a needle in an arm vein one or more times during the course of the~     study. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be collected at a time. No more~     than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period.~      Urine and saliva samples will be collected by the volunteer in private.~      Swab samples will be collected by a nurse or doctor, using a cotton swab to brush inside the~     mouth.~      Samples may be used for the following tests:~        -  Hepatitis and other viral screening-This may include screening for different types of~          viral liver infections, such as hepatitis A, B, C, D, E, or G; for cytomegalovirus~          (related to the herpes virus); and for varicella zoster virus (responsible for chicken~          pox in children and shingles in adults).~        -  Genetic testing-DNA in blood cells may be examined for genetic mutations (physical or~          chemical changes) or deletions (missing pieces) that affect substances involved in the~          body's ability to mount an inflammatory immune response. Alterations in the genes for~          some of these substances have been shown to influence HIV infection.~        -  HLA testing-HLA type is a genetic marker of the immune system. Determining HLA type is~          necessary in order to do certain research studies. Some HLA types have been associated~          with an increased risk of diseases like arthritis and other rheumatologic problems. HLA~          testing may be used to try to identify factors associated with the rate of progression~          of HIV disease or related conditions.~        -  Other laboratory tests as clinically indicated or required for research needs.~      Some samples collected in this study may be stored for future research.They will be labeled~     without identifying information.~      Those with interesting or strongly positive immune responses may be asked to return to the~     VRC Clinic to provide samples of urine or oral secretions.~   "
271600|NCT00027469|"~     This study will use magnetic resonance imaging (MRI) to picture the kidney and renal arteries~     (arteries that supply blood to the kidney) in patients scheduled for kidney artery angiogram~     and angioplasty/stenting procedures. An angiogram is a way of taking pictures of arteries~     that shows areas of narrowing caused by atherosclerosis-a buildup of plaque on the vessel~     wall. Angioplasty/stent is a treatment procedure in which a balloon-tipped catheter is~     inserted in the artery and advanced to the area of blockage to open the vessel, increasing~     blood flow to the kidney. A permanent metal tube (stent) may or may not be put in place to~     maintain the opening. During either of these invasive procedures, small pieces of plaque can~     break off and travel in the blood to lodge elsewhere in the body. This is called~     embolization. Lodged in the kidney, the embolus can impair kidney function. Currently, these~     emboli cannot be detected. A new way of visualizing the kidneys that allows detection of~     emboli may reveal whether material has moved to the kidneys and predict if there will be any~     kidney damage.~      Patients 21 years of age and older with suspected kidney artery disease scheduled for~     invasive angiographic evaluation in NIH protocol 95-H-0047 may be eligible for this study.~      Participants will be assigned to one of two study groups, based on the angiogram findings and~     the decision to have the angioplasty/stent procedure. Participants in both groups will have~     baseline MRI scans up to 2 weeks before the invasive procedure (angiogram with or without~     angioplasty/stent) and again within a day after the procedure. Patients who undergo~     angioplasty/stent will have another MRI study within about a month following the procedure.~      MRI uses a magnetic field and radio waves to produce images of body tissues. The patient lies~     on a table that slides into a large hollow tube (the scanner). During part of the scan, a~     material called gadolinium contrast may be injected into a vein. This substance brightens the~     images to better show the kidneys, their blood vessels and blood flow. The procedure lasts~     from about 1 to 2 hours. During the MRI, the heart is monitored with an electrocardiogram~     (EKG) and breathing is monitored with a flexible belt. Blood pressure is measured~     intermittently. The patient can communicate with a staff member at all times.~      Blood samples will be drawn from an arm vein at the initial clinic visit, within a day after~     the procedure and about 1 week after the procedure. For patients who had the~     angioplasty/stent procedure, a third blood sample will be taken within another 6 six weeks.~     The blood samples will be used to check for changes in kidney function.~   "
271601|NCT00027456|"~     This pilot study will evaluate the safety and effectiveness of leptin therapy in two children~     with severe insulin resistance syndrome. Patients with this condition often have high blood~     sugar levels and may have hormone imbalances, a constant feeling of warmth, fertility~     problems, large appetite, and enlarged liver due to fat accumulation. Leptin is a hormone~     produced by fat cells. It influences appetite, affects levels of reproductive hormones, and~     possibly manages how the body reacts to insufficient food. Certain people with severe insulin~     resistance syndromes have decreased amounts of fat tissue and make little or no leptin.~      A 13-year-old male and an 11-year-old female with severe insulin resistance will participate~     in this study. They will have the following tests and procedures before beginning 4 months of~     leptin therapy:~        -  Insulin tolerance test - measures blood sugar levels after intravenous (IV)~          administration of insulin. Blood samples are collected through the IV tube at various~          intervals during the 1-hour test.~        -  Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies.~        -  Fasting blood tests - to measure blood count, blood lipids, and various hormones and~          assess liver function.~        -  Resting metabolic rate - to measure the amount of oxygen breathed at rest in order to~          calculate how many calories are required to maintain resting body functions.~        -  Magnetic resonance imaging of the liver and other organs, and of muscle and fat.~        -  Pelvic ultrasound in female patient - to detect ovarian cysts.~        -  Estimation of body fat - measurements of height, weight, waist, hip size, and skin folds~          over the arms and abdomen to estimate body fat content.~        -  Oral glucose tolerance test - measures blood sugar and insulin levels. The patient~          drinks a very sweet drink containing glucose (sugar), after which blood samples are~          collected through an IV tube in an arm vein at various intervals during the 3-hour test.~        -  Intravenous glucose tolerance test - measures tissue response to insulin and glucose~          after glucose injection and insulin infusion. Blood is collected over 3 hours to measure~          insulin and glucose levels.~        -  Appetite level and food intake - to measure hunger level and caloric intake. Patients~          are questioned about their hunger level, given a variety of foods they may choose to eat~          and questioned again at various intervals about hunger level. On another day, patients~          are given breakfast (usually a milkshake) and when they want to eat again, the appetite~          level and caloric intake study is repeated.~        -  Hormone function tests - the function of three hormones influenced by leptin~          (corticotropin-releasing hormone, thyrotropin-releasing hormone and luteinizing~          hormone-releasing hormone) are assessed. The hormones are injected intravenously and~          then blood samples are drawn.~        -  Questionnaire - patients complete a questionnaire about their activities and how they~          feel.~        -  24-hour urine collections - to measure specific hormones, proteins and sugars excreted~          in the urine.~      When the above tests are completed, leptin therapy will start. The drug is injected under the~     skin twice a day for 4 months. Patients will record their symptoms weekly throughout the~     study. Those with diabetes will measure their blood glucose levels daily before each meal and~     at bedtime. Follow-up visits at 1, 2 and 4 months after therapy will include a physical~     examination, blood tests and a meeting with a dietitian. At the 4-month visit, the tests done~     at the beginning of the study will be repeated.~   "
271602|NCT00027443|"~     This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in~     patients with giant cell myocarditis (GCM). T lymphocytes appear to be involved in GCM.~     Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits~     lymphocyte activation. This treatment may prolong patient survival until transplantation or~     ventricular assist device placement is possible.~   "
271603|NCT00027430|"~     This is a study to determine whether testosterone replacement with TheraDerm can improve bone~     density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women~     with hypopituitarism.~   "
271604|NCT00027417|"~     This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine~     (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease~     during cardiopulmonary bypass surgery.~   "
272214|NCT00002133|"~     To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients~     with oropharyngeal candidiasis that is refractory to fluconazole.~   "
271609|NCT00027352|"~     The purpose of this study is to compare two ways of using anti-HIV drugs to help health care~     providers and patients decide how to best use anti-HIV treatments over many years. Many~     health care providers now treat patients with daily drugs to keep the viral load as low as~     possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live~     longer without serious diseases. But it is not known if this is the best way to treat~     patients with higher CD4 counts. There is information suggesting that these patients may be~     able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this~     study will be carried out over several years, it will provide information on the long-term~     advantages and disadvantages of these two treatment strategies.~   "
271610|NCT00027339|"~     Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer~     effective treatment options, selecting an effective anti-HIV drug combination is difficult. A~     combination of protease inhibitors (PIs), when added to a patient's current anti-HIV therapy,~     may decrease viral load and increase drug activity. Tests that measure drug levels in the~     blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the~     best anti-HIV drug combination for a patient. This study will determine whether using these~     tests to choose a drug combination and adding PIs to that combination will improve the~     patient's response to anti-HIV therapy.~   "
271611|NCT00027326|"~     Background:~      -Research in NCI's Radiation Oncology Branch depends on the availability of blood and urine~     samples from patients receiving radiation therapy.~      Objectives:~      -To explore the effects of radiation therapy on gene expression in white blood cells, to~     measure radiation damage in red blood cells and to examine changes in hormone levels in the~     blood and urine after radiation therapy.~      Eligibility:~      -Patients 18 years of age and older who are receiving radiation therapy.~      Design:~        -  Blood and urine samples are collected when participants enter the study.~        -  Additional samples may be collected at different times during and after treatment.~          Ideally, samples are obtained before, at the completion of, and 1 month following~          radiation therapy. Blood samples usually will be collected during routine patient~          monitoring procedures and will not require an additional needle stick.~        -  A total of 300 patients will be studied at the NCI in Bethesda, MD, Johns Hopkins~          University in Baltimore and the University of Pennsylvania in Philadelphia.~   "
271612|NCT00027300|"~     The purpose of this study is to determine the safety and efficacy of natalizumab in the~     treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis~     (MS). It is hoped that natalizumab will prevent certain types of white blood cells from~     moving out of the bloodstream into organs, including the brain, that are being damaged by~     autoimmune disease (a disease in which the body's own immune system attacks certain organs).~     These white blood cells are thought to cause inflammation that can result in lesions (small~     areas of damage) in the brain. These lesions are thought to be the cause of relapses and~     disability in MS.~   "
271613|NCT00027287|"~     This study will compare the side effects of two laser treatments for diabetic macular edema,~     a common condition in patients with diabetes. In macular edema, blood vessels in the retina-a~     thin layer of tissue that lines the back of the eye-become leaky and the retina swells. The~     macula-the center part of the retina that is responsible for fine vision-may also swell and~     cause vision loss. Traditional laser treatment (argon blue or green or yellow) for macular~     swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision.~     Studies with a different type of laser (diode) have shown no adverse effects to the retina,~     but long-term effects of this treatment are not known. The results of this study on side~     effects of the treatments will be used to design a larger study of effectiveness. This study~     will also examine whether vitamin E can reduce the damage caused by laser treatment. Patients~     with diabetic eye disease who take vitamin E have increased blood flow through the vessels of~     the retina, as well as improved kidney function. Patients with elevated cholesterol levels~     will be invited to participate in a cholesterol reduction part of the study to compare~     normal-pace cholesterol reduction with accelerated reduction.~      Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be~     eligible for this study. Candidates will be screened with the following tests and procedures:~        -  Medical history - to review past medical conditions and treatments.~        -  Physical examination - to measure vital signs (pulse, blood pressure, temperature,~          breathing rate) and examine the head and neck, heart, lungs, abdomen, arms and legs.~        -  Eye examination - to assess visual acuity (eye chart test) and examine pupils, lens,~          retina, and eye movements. The pupils will be dilated with drops for this examination.~        -  Blood tests - to measure cholesterol and vitamin E blood levels, blood clotting time,~          hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney~          function.~        -  Photography - to help evaluate the status of the retina and changes that may occur in~          the future. Special photographs of the inside of the eye are taken using a camera that~          flashes a bright light into the eye. From 2 to 20 pictures may be taken, depending on~          the eye condition.~        -  Fluorescein angiography - to evaluate the eye's blood vessels. A yellow dye is injected~          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina~          are taken using a camera that flashes a blue light into the eye. The pictures show if~          any dye has leaked from the vessels into the retina, indicating possible blood vessel~          abnormality.~      Participants will be randomly assigned to receive one of the two laser treatments. They will~     also be randomly assigned to take 1600 IU of vitamin E or placebo (an inactive, look-alike~     pill) daily. For the laser treatment, eye drops are put in the eye to numb the surface and a~     contact lens is placed on the eye during the laser beam application. Several visits may be~     required for additional laser treatments. The maximum number of treatments depends on how~     well the treatment is working.~      On their first visit, patients will be given vitamin C. After taking the vitamin for 1 month,~     they will return to the clinic for the first laser treatment. They will followed 1, 3, 6, 9,~     and 12 months after the first treatment, and then every 6 months until either 1) the patient~     returns for a 3-year visit; 2) the last enrolled patient returns for the 1-year visit, or the~     patient requests to leave the study. During these visits, several of the exams described~     above will be repeated to evaluate the response to treatment and check for side effects of~     the vitamin E.~   "
271614|NCT00027274|"~     Background:~      A prospective cohort of Inherited Bone Marrow Failure Syndrome (IBMFS) will provide new~     information regarding cancer rates and types in these disorders.~      Mutations in IBMFS genes are relevant to carcinogenesis in sporadic cancers.~      Patients with IBMFS who develop cancer differ in their genetic and/or environmental features~     from patients with IBMFS who do not develop cancer.~      These cancer-prone families are well suited for cancer screening and prevention trials~     targeting those at increased genetic risk of cancer.~      Carriers of IBMFS gene mutations are at increased risk of cancer.~      The prototype disorder is Fanconi's Anemia (FA); other IBMFS will also be studied.~      Objectives:~      To determine the types and incidence of specific cancers in patients with an IBMFS.~      To investigate the relevance of IBMFS gene mutations in the carcinogenesis pathway of the~     sporadic counterparts of IBMFS-associated cancers.~      To identify risk factors for IBMFS-related cancers in addition to the primary germline~     mutations.~      To determine the risk of cancer in IBMFS carriers.~      Eligibility:~      North American families with a proband with an IBMFS.~      IBMFS suspected by phenotype, confirmed by mutation in an IBMFS gene, or by clinical~     diagnostic test.~      Fanconi's anemia: birth defects, marrow failure, early onset malignancy; positive chromosome~     breakage result.~      Diamond-Blackfan anemia: pure red cell aplasia; elevated red cell adenosine deaminase.~      Dyskeratosis congenita: dysplastic nails, lacey pigmentation, leukoplakia; marrow failure.~      Shwachman-Diamond Syndrome: malabsorption; neutropenia.~      Amegakaryocytic thrombocytopenia: early onset thrombocytopenia.~      Thrombocytopenia absent radii: absent radii; early onset thrombocytopenia.~      Severe Congenital Neutropenia: neutropenia, pyogenic infections, bone marrow maturation~     arrest.~      Pearson's Syndrome: malabsorption, neutropenia, marrow failure, metabolic acidosis; ringed~     sideroblasts.~      Other bone marrow failure syndromes: e.g. Revesz Syndrome, WT, IVIC, radio-ulnar synostosis,~     ataxia-pancytopenia.~      First degree relatives of IBMFS-affected subjects as defined here, i.e. siblings (half or~     full), biologic parents, and children.~      Grandparents of IBMFS-affected subjects.~      Patients in the general population with sporadic tumors of the types seen in the IBMFS (head~     and neck, gastrointestinal, and anogenital cancer), with none of the usual risk factors (e.g.~     smoking, drinking, HPV).~      Design:~      Natural history study, with questionnaires, clinical evaluations, clinical and research~     laboratory test, review of medical records, cancer surveillance.~      Primary endpoints are all cancers, solid tumors, and cancers specific to each type of IBMFS.~      Secondary endpoints are markers of pre-malignant conditions, such as leukoplakia, serum or~     tissue evidence of carcinogenic viruses, and bone marrow morphologic myelodyplastic syndrome~     or cytogenetic clones..~   "
271615|NCT00027261|"~     The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe~     and to study how the immune system responds to the vaccine. This trial is designed to~     determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune~     response.~      As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose.~     The higher dose of the vaccine to be used in this study has not been given to humans~     previously. High doses of a similar vaccine have been given to a few people without serious~     side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger~     immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the~     amount needed for the maximum immune response. Because the exact relationship between an~     increased immune response and its effectiveness in preventing HIV infection is uncertain, the~     HVTN will use the highest dose that can be manufactured.~   "
271616|NCT00027248|"~     Central venous catheters (CVCs) are used in patient care for such purposes as the~     administration of medication, fluids, blood products and for functions such as hemodialysis~     and plasmapheresis. However, the use of CVCs can cause complications such as life-threatening~     bloodstream infections (BSI).~      BSIs are caused by organisms from the skin's surface tracking down the catheter's outer~     surface. The organisms grow on the catheter surface (catheter colonization) which is followed~     by seeding into the bloodstream. BSIs can be difficult to treat and the mortality rate is as~     high as 35% in Intensive Care patients with a catheter-related BSI. It is estimated that up~     to 70,000 patients in the US die each year from catheter-related BSI.~      MBI 226 is a new drug that, when applied to the skin surrounding the catheter insertion site,~     may prevent organisms on the skin from migrating down the catheter and entering the~     bloodstream and therefore decrease the incidence of catheter-related BSI in patients with~     CVCs.~   "
273657|NCT00005730|"~     To serve as a focal point for bone-marrow research.~   "
271617|NCT00027235|"~     Recently, an epidemic of pulmonary disease has been recognized among workers in a popcorn~     factory in Jasper, Missouri. The exposure agent has not yet been identified, but suspects~     include butter flavoring and the powdered salt used in the mixing room. This disease~     resembles Bronchiolitis Obliterans Syndrome, an illness that makes it difficult to breathe.~     Of the 117 workers studied, one year later, 25 subjects whom were working in the mixing room~     or in the microwave packaging area have had decreases in lung function seven times the norm~     for their age. Industrial hygiene experts revealed that dust concentrations of salt and other~     flavorings were much higher in the mixing room compared to the office and outdoor work areas.~     Recently, rats were exposed to vapors created by heating the butter flavor compound obtained~     from this plant. Six-hour exposure to vapors at very high concentration resulted in~     significant damage to the breathing apparatus. Thus, there is clinical, epidemiological, and~     animal toxicity data that appears to implicate some constituent present during the mixing of~     the butter flavoring, salt, and oil causing a form of obstructive airway disease that has~     been rapidly progressive in a number of workers. It is not clear what the pathophysiologic~     nature of this entity is, though it resembles Bronchiolitis Obliterans Syndrome. It is not~     known what the long term consequence of this will be on the active workers, nor is it clear~     whether preventive measures taken to reduce exposures in the mixing room and elsewhere in the~     plant are going to be effective.~   "
271618|NCT00027209|"~     The goal of this study is to evaluate the effect of synthetic hormone replacement therapy on~     anti-seizure medication levels, menopausal symptom relief, and seizure frequency and safety~     in menopausal women with epilepsy.~   "
271619|NCT00027196|"~     Genetically inherited heart diseases (familial cardiopathies) are conditions affecting the~     heart passed on to family members by abnormalities in genetic information. These conditions~     are responsible for many heart related deaths and illnesses.~      Researchers are interested in learning more about the specific genetic abnormalities causing~     heart diseases. In addition, they would like to find out how these abnormal genes can~     contribute to the development of other medical problems.~      In order to do this, researchers plan to study patients and family members of patients~     diagnosed with genetically inherited heart disease. Those people participating in the study~     will undergo a variety of tests including blood tests, echocardiograms, and magnetic~     resonance imaging studies (MRI). These tests will be used to help researchers find the~     genetic problem causing the familial cardiopathy.~      Researchers hope that the information gathered from this study can be used to develop better~     medical care through early diagnosis, management, and treatment plans.~   "
271620|NCT00027183|"~     Some bacteria that cause disease can produce toxic substances that may worsen the disease.~     Pseudomonas aeruginosa is a bacteria that can produce a variety of toxins and is of special~     interest for patients with cystic fibrosis and repeated long term lung infections.~      The goal of this study is to determine whether specific toxins produced by Pseudomonas~     aeruginosa may be important in the disease process of chronic lung infections of patients~     with cystic fibrosis.~      This study will attempt to measure bacterial production of toxins in blood and sputum and~     immune system response to toxins in the blood....~   "
271621|NCT00027170|"~     This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate the~     heart and blood vessels of patients with cardiovascular disease, including better detection~     of myocardial infarction (heart attack) and blockage of heart and leg arteries.~      Patients 18 years of age and older with cardiovascular disease may be eligible for this~     study.~      All participants will have magnetic resonance imaging of the heart. MRI uses a magnetic field~     and radio waves to show structural and chemical changes in tissues. For the procedure, the~     patient lies on a table surrounded by a metal cylinder (the scanner). A 'gadolinium contrast'~     material may be injected into the patient s vein during part of the study to brighten the~     images. Patients wear earplugs during the scan to muffle loud knocking sounds caused by the~     electrical switching of the magnetic fields. They will be asked to hold their breath~     intermittently for 5 to 20 seconds during the scan. They will be monitored with an~     electrocardiogram (EKG) during the procedure and will be in contact by intercom at all times~     with the person performing the scan. Patients can request to stop the study and come out of~     the scanner at any time. The procedure may last from 30 to 90 minutes. An echocardiogram a~     test that uses sound waves to produce pictures of the heart and blood vessels-may be done to~     confirm the MRI findings. In addition, patients may undergo one or more of the following~     optional studies:~        -  Dobutamine stress MRI - This test uses dobutamine-a medicine that simulates exercise by~          increasing heart rate and heart function-to detect blockages in the coronary arteries~          (vessels that supply oxygen and nutrients to the heart) and locate areas of the heart~          that are permanently damaged, perhaps by a previous heart attack. For this test, MRI~          pictures of the heart are taken before, during and after administration of dobutamine.~          Gadolinium may be injected during part of the study to brighten the images. An EKG will~          be used to monitor the heart during the procedure.~        -  Vasodilator MRI - The procedure and objectives of this test are the same as those~          described for dobutamine stress MRI, except that this study uses dipyridamole or~          adenosine. These drugs dilate blood vessels, causing increased blood flow to the heart.~        -  Plethysmography MRI - This test determines the presence and severity of narrowing in~          arteries that supply blood to the leg. Blockage of these vessels often causes pain while~          walking. This study will compare plethysmography MRI with venous occlusion~          plethysmography, an older method of measuring blood flow in the legs. For venous~          occlusion plethysmography, a large blood pressure cuff is placed around the upper leg~          and a strain gauge (thin elastic band) is placed around the calf. The pressure cuff is~          inflated very tightly for 5 minutes to block blood flow to the leg, and another pressure~          cuff over the ankle is also inflated. When the large cuff is deflated, blood rushes to~          the leg, a smaller cuff is inflated to a low pressure, and the strain gauge measures the~          maximum blood flow to the leg for 1 or 2 more minutes. This procedure is done once or~          twice outside the MRI scanner and once or twice inside the scanner. The scans are~          performed as described above for the dobutamine and vasodilator studies. The strain~          gauge is not used for plethysmography MRI the MRI pictures are used to measure flow.~   "
271622|NCT00027157|"~     This study will determine whether and how nitrites and nitrates in the diet affect the level~     of nitric oxide gas that is breathed out in air. Nitric oxide is involved in many bodily~     processes, such as immune function, nerve signal transmission, inflammation, and dilation of~     blood vessels and bronchial tubes (tubes that branch out from the trachea into the lungs).~      Healthy male volunteers age 18 years or older who have not smoked for at least 5 years may be~     eligible for this study. Candidates will undergo blood and urine tests, breathing tests, and~     an electrocardiogram.~      Participants will follow two special diets for 3 days each. One is a low-nitrate and nitrite~     diet, and the other is a high-nitrate and nitrite diet. Both diets must be completed within a~     month's time. Participants will be admitted to the NIH Clinical Center for two 3-night~     hospital stays during the two diet periods, but may go out on passes at any time. While on~     the diets, they may consume only food prepared by the NIH Nutrition Department; eating other~     foods will seriously affect the study results. Meals may be eaten at the NIH Clinical Center,~     or packaged meals prepared by the Nutrition Department can be taken out. Participants may not~     engage in any heavy exercise during the diet periods, as exercise affects nitric oxide~     levels.~      Blood samples of about 4 milliliters, or 1 teaspoon, each will be collected before starting~     each diet and at the end of each diet to measure blood levels of nitrate and nitrite.~     Additional blood samples, totaling about 2 tablespoons, will be collected for research. Each~     day, participants will have a test to measure exhaled nitric oxide levels. This involves~     blowing air into a mouthpiece attached to a machine that measures levels of the gas in each~     breath.~   "
271623|NCT00027144|"~     Description: The trial is designed to determine the response of the immune system of patients~     with CML to a vaccine made from their own tumor. Researchers believe that this particular~     vaccine, which is made from purified heat shock proteins taken from each patient's tumor,~     alerts the body's immune system to recognize and attack invading cancer. To be considered~     potentially eligible for this study you must have CML in the chronic phase.~      Length/Duration: Vaccinations will be administered weekly for eight weeks. One clinic follow~     up visit will be scheduled two weeks after the final vaccination.~   "
271624|NCT00027131|"~     Description: The trial is designed to determine the response of the immune system of patients~     with breast cancer to a vaccine made from their own tumor. Researchers believe that this~     particular vaccine, which is made from purified heat shock proteins taken from each patient's~     tumor, might alert the body's immune system to recognize and attack invading cancer. To be~     considered potentially eligible for this study you must be a high risk breast cancer patient~     and have a tumor that can be removed surgically.~      Length/Duration: Vaccinations are administered weekly for six weeks. Follow up visits to the~     clinic are every three months for two years, then every six months thereafter.~   "
271643|NCT00026884|"~     Selected patients suspected of having or with prior biopsy proof of malignant disease will be~     seen in the Urologic Oncology Branch, NCI. Blood samples may be collected at the time of the~     initial visit and at periodic intervals during the course of the disease. These samples will~     be stored in the tissue bank of the Urologic Oncology Branch. Aliquots of malignant and~     normal tissue will be collected at the time of surgery and stored in the tissue bank,~     Urologic Oncology Branch, NCI. These materials will be used in the research efforts of the~     Urologic Oncology Branch, NCI....~   "
271625|NCT00027118|"~     This study will examine the frequency and severity of problems in women with breast cancer~     for 2 years following initial medical treatment, including:~        -  Physical impairments, such as loss of strength or flexibility, increased weight and~          swelling.~        -  Symptom distress, such as pain, fatigue and weakness.~        -  Functional limitations and disabilities, such as loss of independence in activities of~          daily living (e.g., grooming, bathing, dressing, driving a car), work and social and~          recreational activities.~      It will identify factors associated with these problems and try to determine their~     relationship to them.~      Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible~     for this study. Women who have a breast biopsy negative for cancer will also be enrolled as~     control subjects. Participants will be drawn from patients referred to the National Naval~     Medical Center for diagnosis and treatment during 2001-2003.~      Participants will be evaluated over a 2-year period during an initial baseline visit (before~     medical treatment or biopsy) and follow-up visits at 1, 3, 6, 12, 18 and 24 months following~     procedures:~        -  Interview about past medical history and present illness, social and recreational~          activities, functional independence at work and during activities of daily living.~        -  Completion of questionnaires including health survey, upper limb disability~          questionnaire, and physical activity questionnaire. (Questionnaires are completed only~          at baseline and 12 and 24 months after medical treatment begins.) The questionnaires~          take about 30 to 40 minutes to complete.~        -  Upper body examination, including pain measurement using a 10-point scale, active and~          passive range of motion measures, manual muscle testing measures using a 10-point scale,~          timed upper limb lift test, and measures of upper limb volume and girth.~   "
271626|NCT00027105|"~     This study will examine the frequency and severity of problems in women with breast cancer~     during the first year after initial medical treatment, including:~        -  Physical impairments, such as loss of strength or flexibility, increased weight and~          swelling~        -  Symptom distress, such as pain, fatigue and weakness.~        -  Functional limitations and disabilities, such as loss of independence in activities of~          daily living (e.g., grooming, bathing, dressing, driving a car), work and social and~          recreational activities.~      It will identify factors associated with these problems and try to determine their~     relationship to them.~      Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible~     for this study. Participants will be drawn from patients referred to the National Naval~     Medical Center for diagnosis and treatment during 2000-20001.~      Participants will be interviewed and their medical records reviewed for past medical history,~     history of the present illness and social and recreational history. They will be seen five~     times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute~     visits, which will include the following:~        -  Interview about past medical history and present illness, social and recreational~          activities, functional independence at work and during activities of daily living.~        -  Complete health survey and upper limb disability questionnaire; physical activity~          questionnaire to be completed at 6 and 12 months after medical treatment begins. The~          questionnaires take about 30 to 40 minutes to complete.~        -  Upper body examination, including pain measurement using a 10-point scale, an upper limb~          lift test, and measures of upper limb volume and girth.~   "
271627|NCT00027092|"~     The purpose of this study is to find out if testosterone gel affects how the body handles~     insulin and glucose.~      Specific anti-HIV treatments may increase a patient's risk of certain diseases by causing~     metabolic problems such as reduced sensitivity to insulin. This substudy will examine how~     testosterone affects insulin sensitivity. If testosterone increases insulin sensitivity in~     the patients, then giving testosterone to HIV-infected patients may allow the continuation of~     anti-HIV treatments without increasing the patients' risk of disease. The test used to~     determine insulin sensitivity will be a modified frequently sampled intravenous glucose~     tolerance test (FSIVGTT), which can accurately measure insulin sensitivity.~   "
271628|NCT00027079|"~     This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both~     alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All~     subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will~     be completed at 1, 3, 6, and 9 months after treatment.~   "
271629|NCT00027066|"~     The goal of this study is to compare aspirin to warfarin for the prevention of recurrent~     stroke.~   "
271630|NCT00027053|"~     This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and~     placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an~     inpatient detoxification program. Subjects will undergo a baseline assessment and random~     assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol~     detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of~     Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)~   "
271631|NCT00027040|"~     The purpose of this study is to compare pictures of the brain of HIV-infected people with~     memory problems before and after treatment with selegiline. Selegiline is the study drug~     received through A5090.~      HIV patients generally develop memory problems late in the disease. This will be examined~     using noninvasive proton magnetic resonance spectroscopy (1H-MRS). The effect of the drug~     selegiline on memory problems also will be examined.~   "
271632|NCT00027027|"~     The purpose of this Phase I study is to test the safety of rhuMAb 2C4 to see what effects~     (good and bad) it has on patients with certain types of cancer, and also to find the highest~     dose of rhuMAb that can be given without causing severe side effects. All study participants~     will be assigned to specific group to evaluate different dosages of rhuMAb 2C4. The study is~     scheduled to run for up to one year depending on how patients respond to the study treatment.~   "
271633|NCT00027014|"~     This is a series of studies in healthy volunteers to assess the potential for adverse~     interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain~     medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether~     SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of~     standard doses of oxycodone in treating pain problems. For the fentanyl study, we will~     investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain~     and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW~     treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in~     the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other~     dietary and environmental toxins.~   "
271765|NCT00016718|"~     Treatment of HIV-infected patients involves combining drugs from different classes of~     anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase~     inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too~     complicated or the drugs may be too difficult to take by mouth. The purpose of this study was~     to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz~     (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.~   "
271634|NCT00027001|"~     The goal of this study is to improve the overall physical health and quality of life of~     patients attached to mechanical heart devices while awaiting heart transplantation. Qigong,~     an ancient Chinese exercise that involves active participation of the individual in the form~     of meditation, breathing exercises and simple physical movements, is used in combination with~     a structured exercise program. We are testing the hypotheses that Qigong, in combination with~     a structured exercise program that combines aerobic and resistance training will improve the~     cardiovascular health and improve the quality of life of patients on mechanical heart~     devices. To test these hypotheses, we are measuring cardiovascular function and quality of~     life parameters in patients attached to mechanical heart devices who have participated in the~     exercise program and have practiced Qigong, and comparing these measures to patients who~     participated in the exercise program, but did not practice Qigong. Information gained from~     this research will serve as a basis from which the application of exercise training and~     Qigong can be applied to the treatment of other chronic diseases in which the physical~     conditioning and/or quality of life of individuals is compromised.~   "
271635|NCT00026988|"~     This study, CREST-HD, will examine the safety and tolerability of 8 grams of creatine in~     subjects affected by Huntington's disease (HD). Biochemistry and neuroimaging will be used to~     examine the potential effects of creatine on HD.~   "
271636|NCT00026975|"~     This study is designed to develop a predictive model for the development of wound~     complications in patients undergoing laryngectomy surgery for laryngeal/adjoining structure~     cancers, and to evaluate the clinical efficacy of hyperbaric oxygen for the~     prevention/management of wound complications in this previously irradiated population. The~     eligibility profile welcomes the involvement of patients in need of laryngectomies for newly~     diagnosed cancers and for failed chemoradiation. Patients are afforded the opportunity to be~     cared for by some of the most distinguished head & neck surgeons and hyperbaric medicine~     physicians at the University of Pennsylvania in Philadelphia, the oldest teaching medical~     facility in the country, as well as the Philadelphia Veterans Affairs Medical Center. In~     addition, participants will be contributing to a body of research uncovering new methods for~     the assessment of tissue/tumor oxygenation, modeling to promote early wound complication~     identification, and confirming the role of hyperbaric oxygen therapy in the care and~     prevention of these problem wounds.~   "
271637|NCT00026962|"~     Blood levels of the hormones estradiol and progesterone are of interest in evaluating ovarian~     function. However, because these hormone levels vary from day to day, blood samples must be~     taken very often or elaborately timed to specific phases of the menstrual cycle. A method has~     now been developed for measuring estradiol and progesterone levels in saliva. This study will~     test the accuracy of this method and examine whether salivary levels of these hormones change~     after treatment with raloxifene.~      Hormone levels will be measured during 3 menstrual cycles in women currently enrolled in the~     clinical study, A Phase II Trial of Two Doses of Raloxifene in Women at Risk of Developing~     Invasive Breast Cancer. Participants will provide a saliva sample every morning for about a~     month during three collection periods-1 month before beginning raloxifene treatment, and 3~     and 12 months after treatment starts. Patients will be given kits for collecting the samples~     and mailing them to the laboratory at the end of each collection period.~   "
271638|NCT00026949|"~     This study will examine how the body handles etoposide, a drug used to treat breast cancer.~     The knowledge gained may lead to more effective use of the drug with fewer side effects in~     the future.~      Breast cancer patients who are receiving etoposide as part of their treatment may participate~     in this study. Patients will have 18 blood samples (about a teaspoon or less each) drawn over~     a 72-hour period during and after their infusion of etoposide. The initial blood samples~     cannot be taken from the same intravenous line (small tube placed in a vein) used to deliver~     the etoposide, so a second line may have to be placed temporarily to obtain these samples.~   "
271639|NCT00026936|"~     The utility of PEREGRINE Monte Carlo calculations for radiation treatment planning in a~     clinical setting will be assessed by comparing results with other fully three-dimensional~     programs. ROB will investigate PEREGRINE for clinical use at NCI in collaboration with~     Lawrence Livermore National Laboratory (LLNL).~   "
271640|NCT00026923|"~     This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic~     surgery is performed through small holes in the abdomen called ports. A camera is passed~     through one port for visualization. Laparoscopic surgery requires an assistant to hold the~     camera and help the operating surgeon view the surgical field. The assistant camera holder~     may be a surgeon or a robotic arm. The robotic arm is usually controlled by the operating~     surgeon. In this study, a robotic arm holding the camera will be used, and will be controlled~     by a surgeon outside the operating room.~   "
271641|NCT00026910|"~     Although the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are~     unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of~     apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and~     tumor proliferation all have significant effects on clinical drug resistance. To further~     investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate~     the expression of multiple molecular targets [including but not restricted to bcl-2, BAX,~     bcl-6, MIB-1, p53, p21, p27, p16, cyclin D(1), cyclin A, cyclin E, mdm-2, cpp 32, mcl-1,~     EBER-1, ALK, and a panel of B, T and other cell lineage markers], involving these pathways,~     with clinical outcome following treatment with combination chemotherapy. All clinical data~     and tissue samples for this study will come from patients who have been previously enrolled~     on two protocols for the initial treatment of aggressive lymphomas. No new patients will be~     enrolled for this study.~   "
271642|NCT00026897|"~     Patients undergoing immunotherapy for advanced cancer under IRB-approved protocols, who are~     to receive immune cells in adoptive transfer, will have less than or equal to 50% of those~     cells labeled with In-111-oxine and administered along with the remainder of their unlabeled~     cells. They will then undergo gamma-camera imaging over the next 0-7 days and blood samples~     and tumor sites which are accessible with minimal surgery (low-risk biopsy) may be sampled in~     some patients for enumeration of radiolabeled cells. End-points will be tumor and normal~     organ imaging and the amount of In-111 per gram of tissue in biopsies or per ml. of blood.~   "
272215|NCT00002132|"~     To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets~     for the treatment of esophageal candidiasis in immunocompromised patients.~   "
271644|NCT00026871|"~     We propose to determine the response of a newly developed laser heated, vycor glass~     fiberoptic radiation dosimetry system to ionizing radiation in a clinical radiotherapy~     environment. Present systems measure only total dose or have limitations, such as~     instability, non-linearity, excessive size or a decoupled measurement system, making them~     unsuitable in a variety of clinical applications. This fiberoptic coupled dosimetry system is~     a new and innovative technology application which allows on-line measurement of instantaneous~     dose rate and total dose never before achievable. It offers a clear advantage in patient~     treatment delivery, allowing on-line corrections essential to a new generation of~     radiotherapy treatment machines with development of beam intensity modulation as an adjunct~     to 3D conformal therapy. It also has the advantage of submillimeter size and is minimally~     invasive, making it ideal for brachytherapy.~      This system has the potential for stable, accurate, reproducible, clinically feasible~     measurements of total dose and dose rate. The output of this system will be measured under~     various clinical conditions encountered in a clinical setting and compared against existing~     thermolumeniscent and diode dosimetry standards. Initial measurements will use a tissue~     equivalent phantom for depth dose and accuracy measurements. Additional studies will include~     dosimetric measurements of routine clinical treatment setups on patients receiving~     therapeutic irradiation.~   "
271645|NCT00026858|"~     Most bone marrow transplantations for malignant and non-malignant disease include whole body~     irradiation. Techniques for administering that treatment, including patient positioning, lung~     and soft tissue compensation, dose rate, total dose and fractionation differ between~     institutions. These differences are optimized at each institution to limit toxicity and~     maximize therapeutic outcome.~      Technically complex procedures such as total body radiation are subject to equipment~     failures. Such failures mid-treatment could be catastrophic to the patient, since therapy~     must be timely and compatible therapy may not be available elsewhere in the community. The~     purpose of this protocol is to provide backup between George Washington University Medical~     Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and~     compatible therapies in the event of equipment failure; or replacement of a linear~     accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent~     situation.~   "
271646|NCT00026832|"~     The purpose of this study is to evaluate the function of certain brain chemicals and~     receptors in patients with mood disorders. This study will also examine how the stress~     hormone cortisol affects brain function.~      Data suggest that serotonin 1A (5-HT1A) receptor function is abnormal in patients with mood~     disorders, such as major depressive disorder (MDD) and bipolar disorder (BP). However, these~     data are limited because they are based on small sample sizes. In this study, PET scans will~     be used to compare 5-HT1A receptor binding potential between mood disorder patients and~     healthy volunteers.~      All participants will have an initial medical and psychiatric evaluation. Depression~     severity, anxiety, negative thinking, level of functioning, intelligence, and cognitive~     functions will be measured. Urine, saliva, and blood will be collected. Women will have a~     pregnancy test and tests to determine menstrual phase and time of ovulation. Participants~     will undergo magnetic resonance imaging (MRI) and PET scans of the brain. Some participants~     will have other procedures such as a lumbar puncture. Participants with Cushing's disease~     will undergo imaging as a comparison group.~   "
271647|NCT00026819|"~     This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID)~     called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food~     and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis,~     menstrual cramps, and pain.~      Healthy normal volunteers between 16 and 35 years of age in general good health who require~     third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be~     screened with a medical history and oral examination, including dental x-rays as needed to~     confirm the need for third molar removal.~      Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small~     piece of tissue) will be taken from the inside of the cheek around the area behind the lower~     wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard~     anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill~     with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine)~     in the mouth and a sedative (midazolam) through an arm vein.~      After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and~     the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is~     unrelieved an hour after surgery may request and receive morphine intravenously (through a~     vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol~     with codeine and the study drug) and instructions for their use. They will also be given a~     pain diary to record pain ratings and medications taken at home. A clinic staff member will~     telephone patients at home the morning after surgery to ensure they are rating their pain~     intensity at the proper time and are taking their medications as instructed.~      Patients will return to the clinic 48 hours after surgery with the pain diary and pain~     relievers. At this visit, another biopsy will be taken under local anesthetic.~   "
271648|NCT00026806|"~     This study will examine the emotional and behavioral aspects of long-term survival of~     HIV/AIDS among adolescents and young adults with HIV infection.~      HIV-infected individuals between 13 and 23 years of age may be eligible for this study. They~     must be aware of their HIV diagnosis, have been infected for at least 13 years and have been~     on an active NIH protocol during the past 5 years.~      In addition to the usual stresses of growing up, children with HIV infection may have spent~     much of their time in hospitals and may have lost parents, friends and other loved ones. This~     study will explore psychological aspects of growing up with HIV, including self esteem,~     possible risk behaviors, how disclosure to others changes over time, the commonness of~     anxiety and depression, and the impact that losses have had on the adolescents' emotional~     health. To gather this information, participants will be interviewed and asked to fill out a~     set of forms. Caregivers will also fill out forms.~      Patients who are not currently on an active NIH protocol will have the option of having a~     physical examination and routine blood work. The results will be sent to their home care~     provider.~   "
271720|NCT00024492|"~     Liposome entrapped mitoxantrone (LEM) is a mixture of commercially available mitoxantrone HCL~     (Novantrone) and a combination of lyophilized lipids. Mitoxantrone, the active agent in the~     investigational formulation, is a currently marketed chemotherapeutic agent. The rationale~     for development of liposomal formulations is primarily that of improving the safety profile~     of the drug, which may permit dose intensification and/or an increase in the cumulative dose~     that may be administered, resulting in enhanced efficacy.~      LEM will be given to patients with advanced solid tumors to determine the dose of drug these~     patients can tolerate. Patients will receive intravenous LEM every 21 days until the disease~     progresses or toxicity occurs requiring treatment discontinuation. Anti-tumor effects of LEM~     will be assessed and patients will be evaluated for safety and tolerability.~   "
272216|NCT00002131|"~     To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related~     Kaposi's sarcoma.~   "
271649|NCT00026793|"~     The purpose of this study is to develop imaging techniques to determine the density of blood~     vessels and the amount of blood flow in Kaposi s sarcoma (KS) tumors. KS tumors depend on the~     formation of new blood vessels for their growth. Some experimental therapies for KS are~     directed at reducing the amount of blood vessels and blood flow in these lesions. Measurement~     of blood vessel density and blood flow in these lesions could be useful in evaluating the~     effectiveness of both standard and experimental treatments for this disease.~      Patients 18 years of age or older with Kaposi s sarcoma involving the skin may be eligible~     for this study. Participants will have photographs taken of their lesions and will undergo~     three imaging procedures (described below) at the beginning of the study (baseline) and then~     about once every 3 months or so while on the study (up to 2 years) to compare the test~     results over time. (Imaging may be done at more or less frequent intervals depending on the~     findings.) A small amount of blood (less than a tablespoon) will be drawn the day of each~     imaging procedure.~      Laser Doppler imaging This technique measures the amount of blood flow in KS lesions by~     scanning the lesions with a low-power laser beam. Each lesion takes about 3 minutes to scan.~     The imaging may be done before and after a blood pressure cuff around the arm is inflated for~     a short time (usually less than 30 seconds).~      Multi-spectral imaging This technique uses light to measure the total blood volume in each~     lesion and how much oxygen is in the blood. Oxygen is carried to the body s cells by a~     protein in red blood cells called hemoglobin. The light on the multi-spectral imaging~     instrument is absorbed differently depending on whether the hemoglobin has oxygen attached to~     it or not. It takes about 2 minutes to scan each lesion.~      Infrared thermal imaging This test uses a special camera to take digital infrared pictures of~     the skin. Images formed of the temperature of the KS lesions are used to assess blood flow in~     the lesions. This imaging takes about 1 minute per lesion.~   "
271650|NCT00026780|"~     Patients who are being considered for participation in a NCI Pediatric Oncology Branch~     research study will be screened for eligibility under this protocol. For every NCI research~     study, patients must meet defined medical criteria in order to ensure the integrity of the~     research study and to maximize patient safety.~      Tests and procedures required for determining eligibility depend on the specific study for~     which the patient is being considered. Some of the more common tests and procedures are:~        -  History and physical examination~        -  Blood and urine samples for routine laboratory tests and possibly research studies~        -  Quality of life assessment questionnaire~        -  Magnetic resonance imaging (MRI) scan uses a magnetic field and radio waves to produce~          pictures of body structures, including tumors~        -  Computerized tomography (CT) scan uses radiation to produce multiple detailed pictures~          of body structures~        -  X-rays uses radiation to provide a single picture of a body part~        -  Nuclear medicine scans uses a chemical tagged with a radioactive substance to detect~          tumors, measure kidney or heart function, or monitor the flow of cerebrospinal fluid~          (fluid that bathes the brain and spinal cord)~        -  Electrocardiogram (EKG) uses electrodes placed on the skin to evaluates heart rate and~          rhythm by measuring electrical impulses from the heart~        -  Echocardiogram uses high-frequency sound waves to evaluate heart structure and function~        -  Lumbar puncture tests for cancer cells and other substances in cerebrospinal fluid.~          Involves placing a needle into the lower back between the bones of the spine and~          withdrawing a fluid sample from the fluid-containing space below the spinal cord~        -  Ommaya reservoir surgically implanted catheter inserted into the fluid-filled ventricles~          of the brain, used to withdraw spinal fluid samples and to give medication~        -  Eye examination vision test and eye examination~        -  Biopsies removal of a small piece of tissue, by needle or by surgery, for examination~          under the microscope. An area of skin over the biopsy site is numbed with an anesthetic.~          For a needle biopsy, a needle is inserted into the tumor, tissue or bone marrow to pull~          out a small sample. A surgical biopsy may be done in the operating room, clinic, or~          hospital room, depending on the biopsy location. The tissue or tumor is removed by~          cutting a small piece of it with a sharp knife or scalpel and the area will be closed~          with sutures or staples.~   "
271651|NCT00026767|"~     This study will collect data on the incidence (rate of occurrence) of fungal infections in~     recipients of bone marrow, stem cell or organ transplants. The data will provide information~     needed to develop strategies for prevention and early treatment of fungal infections in these~     patients.~      Any patient receiving bone marrow transplantation, peripheral stem cell transplantation or~     solid organ transplantation is eligible for this study.~      The survey will be conducted over a 3-year period at about 20 collaborating transplant~     centers. Through the annual accrual of more than 9,000 patients, it is estimated that at~     least 5 to 8 percent per year will have documented or suspected invasive fungal infections.~      The study will be conducted in three phases as follows:~        -  Phase 1 A 6-month start-up phase during which sites will initiate screening and begin~          collecting data on incident cases of invasive fungal infections.~        -  Phase 2 A 2-year phase in which all sites will conduct surveillance and collect data and~          specimens in a standardized fashion.~        -  Phase 3 A 6-month wrap-up phase during which active surveillance for invasive fungal~          infections will be conducted only among patients who were transplanted before the~          beginning of this phase.~      Patient care will be provided through the patient s primary protocol and standard of care.~   "
271652|NCT00026754|"~     The purpose of this protocol is to provide patients with adequate informed consent to~     understand that screening tests with minimal health risk will be performed to evaluate their~     eligibility for a research study. The protocol makes it clear that patients initial visit to~     the intramural clinical program may include screening studies that are not medically~     necessary for disease management, but are done purely for research purposes.~      Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or~     immunodeficiency who are being considered for enrollment in a National Cancer Institute~     intramural clinical research protocol will participate in this consent protocol. It informs~     patients of screening tests and procedures involving minimal risk that are done for research~     purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray),~     bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine~     studies. It explains that other eligibility screens that are more invasive and involve~     greater risk, such as a biopsy, will require separate consent.~   "
271653|NCT00026741|"~     This study will examine the production of proteins called chemokines in inflammatory skin~     reactions. It is thought that chemokines attract or recruit white blood cells from the blood~     stream into the skin when there is a skin injury or infection, causing inflammation. This~     study will examine chemokine production in induced inflammatory reactions to try to gain a~     better understanding of how white blood cells are attracted to inflamed areas of the body.~      Healthy normal volunteers between 33 and 60 years old may be eligible for this study if they~     1) have no history of chronic skin disease; 2) are not allergic to eggs; and 3) do not tend~     to form large irregular scars after trauma to the skin from, for example, cuts, scratches and~     surgical incisions. Candidates will be asked a short series of questions and have a limited~     skin examination.~      Participants will have 10 ml (2 tablespoons) of blood drawn from an arm vein at the start and~     end of the 5-day study and undergo the following procedures:~        1. Day 1 - Participants receive an injection in the right upper arm of mumps antigen (a~          protein commonly used to tests for immunization against mumps) and an injection of~          vehicle (saline plus the preservatives thimerosal, glycine and formaldehyde) in the~          left upper arm.~        2. Day 3 - Participants who develop a swelling from the mumps antigen larger than 5 mm wide~          will receive another injection of antigen in the right arm and another injection of~          vehicle in the left arm. Those whose swelling is not greater than 5 mm will be excluded~          from the study at this point.~        3. Day 5 - All four injection sites, plus another site on the left upper arm will be~          biopsied. For this procedure the five injection areas are numbed with a local~          anesthetic. A punch biopsy instrument that resembles a small cookie cutter (about~          one-third the diameter of a dime) is inserted about one-fifth of an inch deep into the~          skin and the tissue is removed. Two stitches are used to close the wound. Antibiotic and~          bandages are applied for 5 days. Nine days after the biopsy the participant returns to~          NIH for removal of the stitches.~      New molecular biology techniques will be used to measure changes in chemokine production in~     the biopsied tissue.~   "
271766|NCT00016692|"~     The purpose of the study is to see if Z-100 (an investigational drug) treatment is safe in~     HIV patients who have never received treatment for their HIV, who have not been taking highly~     active antiretroviral therapy (HAART) for at least 8 weeks, or who have been stable on their~     current first or second HAART regimen for at least 12 weeks.~   "
271654|NCT00026728|"~     This study will investigate patterns of Kaposi's sarcoma herpes virus (KSHV) in the United~     States and its potential impact on the U.S. population. KSHV is a newly discovered virus that~     is strongly associated with Kaposi's sarcoma and primary effusion lymphoma. The high~     prevalence of KS and KSHV among HIV-infected homosexual men suggests sexual contact as a~     primary mode of transmission. Reports of non-sexual transmission in parts of Africa and the~     Mediterranean where Kaposi's sarcoma is endemic, and the identification of viral DNA in~     saliva and other bodily fluids, however, indicate the virus is also transmitted non-sexually.~     This study will:~        -  Compare the prevalence of KSHV among different demographic groups in the United States~        -  Examine the association between KSHV and high risk behaviors such as drug use (marijuana~          and cocaine), sexual behavior (age at first sexual intercourse and number of sexual~          partners), and medical risk factors (herpes simplex virus II, hepatitis B and hepatitis~          C)~        -  Estimate the prevalence of KSHV in the United States.~      Data and blood samples for the study will be taken from the NHANES III survey. NHANES is a~     program of periodic surveys conducted by the Centers for Disease Control and Prevention's~     National Center for Health Statistics. The survey is designed to provide national estimates~     of health status for the United States non-institutionalized civilian population by means of~     household interviews, standardized physical examinations, and blood sample collection and~     testing. NHANES III-the seventh in a series of national examination studies-was conducted~     from 1988 to 1994.~      This study will use the HANES data to identify risks associated with a KSHV-positive blood~     test in the survey population. The study plans to include all 19,754 participants (67% of the~     29,314 participants originally examined) for whom blood samples were collected and remain~     available.~   "
271655|NCT00026715|"~     This study will test the accuracy of a new Fast GFR (glomerular filtration rate) test to~     evaluate kidney function. Accurate assessment of kidney function is important in many~     clinical situations, including detecting kidney disease early, determining appropriate drug~     dosages, deciding when to begin dialysis, and evaluating heart and kidney organ donors and~     recipients. The current GFR test is used mostly for research purposes, as it is too costly~     and complicated for general medical use. Another significant drawback to its use in~     diagnosing acute kidney failure is the time it takes (3 to 24 hours) to complete, since~     effective therapy for this condition requires its detection as soon as possible. The Fast~     GFR, by comparison, takes only 45 minutes.~      Patients 6 years old and older with kidney disease or with impaired kidney function caused by~     abnormal heart function or swelling-from congestive heart failure, severe infections,~     swelling from fluid accumulation, fluid in the abdomen, or burns-may be eligible for this~     study. Patients will undergo both the standard and the Fast GFR tests, described below, to~     evaluate the accuracy of the new test.~      Fast GFR: Two catheters (thin flexible tubes) are placed into two arm veins, one for~     injecting iothalamate-an agent commonly used in CT scanning and blood vessel imaging-and the~     other for collecting blood samples. Baseline blood and urine samples are collected and then~     0.5 milliliter (ml) iothalamate is injected into a vein. Blood samples are collected at 5,~     10, 15, 20, 30, and 45 minutes in adults and at 5, 15, and 45 minutes in children. Urine is~     collected at 45 minutes. The size of the bladder is measured using ultrasound to determine if~     the bladder has completely emptied.~      Standard GFR: Iothalamate (1 ml) is injected under the skin. Blood samples are collected at~     60, 90, 120, 180 and 240 minutes. (A heparin lock is used to avoid multiple needle sticks.)~     Urine is collected at 60, 90, 120, 180 and 240 minutes. The size of the bladder is measured~     using ultrasound to determine if the bladder has completely emptied.~   "
271656|NCT00026702|"~     The purpose of this study is to find substances in the blood and urine that indicate that a~     person has kidney damage. It will identify proteins found only in patients with acute kidney~     failure but not in normal healthy people or in patients with volume depletion.~      Adults and children who are at least 3 years old who fall into one of the following four~     categories may be eligible for this study:~        1. Are healthy and have normal kidney function~        2. Have volume depletion (this condition differs from acute kidney failure in that it is~          easily treated with fluids)~        3. Are at high risk of kidney failure~        4. Have acute kidney failure (kidney shutdown)~      All study participants will have a history and physical examination. Up to four blood samples~     of 3 tablespoons each will be taken for laboratory analysis. Urine will be collected for~     analysis and to measure urine output. The participants length of stay in the study varies.~     People with normal kidney function will be in the study for 1 day and patients with volume~     depletion will be studied 3 days. The length of hospitalization of patients at high risk of~     kidney failure or in acute kidney failure will depend on the patient s condition and~     medication requirements.~      The results of this study may lead to the development of earlier and more accurate methods~     for diagnosing acute kidney failure. With earlier detection, treatment could be started~     earlier, possibly preventing further damage and helping recovery of injury that has already~     occurred.~   "
271657|NCT00026689|"~     Background:~      -This protocol will provide a means for screening potential candidates for NCI Radiation~     Oncology Branch (ROB) protocols.~      Objectives:~      -To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to~     identify individuals who will be suitable candidates for Radiation Oncology Branch clinical~     research protocols.~      Eligibility:~      -Patients suspected of having, or with biopsy proven malignant disease or patients with a~     benign condition for whom radiotherapy is a potential treatment.~      Design:~      -This is a screening protocol. No investigational treatments will be administered on this~     protocol.~   "
271658|NCT00026676|"~     Recent studies have shown that patients receiving state-of-the-art treatment for HIV~     infection (highly active antiretroviral therapy, or HAART) show discordant responses to~     therapy-that is, they improve both clinically and immunologically (increased CD4 immune cell~     counts), but their levels of HIV in the blood do not drop. This study will examine blood~     samples taken from HIV-infected children treated with 2',3'-dideoxyinosine (didanosine, or~     ddI) in an earlier NCI study to determine if these patients had similar discordant responses~     to therapy. If so, the study will also examine how these factors may be predictive of disease~     progression and survival.~      Investigators will measure HIV levels in blood specimens from children previously enrolled in~     NCI protocol 88-C-0129. The measurements will be done in specimens drawn before initiation of~     treatment with ddI and at various times during the course of treatment. The viral responses~     to therapy will then be correlated with short- and long-term clinical and immunologic~     outcomes.~      In addition, researchers will examine these patients' blood samples for additional factors~     recently discovered to potentially influence disease progression. They include selenium~     levels and certain genetic factors.~      A better understanding of discordant responses to therapy will help physicians determine the~     best treatment option in situations where therapy results do not show uniform benefit.~      This protocol involves the scientific examination of laboratory specimens only and is not a~     clinical study open to patient enrollment.~   "
271730|NCT00023413|"~     The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will~     enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based~     regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg~     daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in~     this study.~      Primary Objective:~      To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with~     efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without~     efavirenz.~   "
271956|NCT00002392|"~     To ascertain the effect of thalidomide on immune responses to vaccination with polyvalent~     pneumococcal polysaccharide vaccine and tetanus toxoid in HIV-infected patients;~     particularly, on markers of immune activation and parameters of specific, anti-HIV cellular~     immunity.~   "
271659|NCT00026663|"~     This study will examine blood, bone marrow, tumor and tissue samples from patients with~     cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer~     improve initially with chemotherapy, but then have a disease relapse, after which their tumor~     no longer responds to treatment. Other patients tumors are drug-resistant from the start. The~     study will look for resistance factors substances in blood and tissues that render tumors~     resistant to chemotherapy. The findings may provide information needed to develop methods of~     combating drug resistance.~      Patients with cancer who are 18 years or older may be eligible for this study. Participants~     will have 40 milliliters (3 tablespoons) of blood drawn at the beginning of the study;~     additional samples will be obtained periodically during the course of treatment. A small~     sample of tumor or normal tissue will be taken from patients who undergo surgery or tumor~     biopsy (removal of a small piece of tumor) for medical reasons or as part of a research~     treatment protocol. Patients who do not require surgery or biopsy may be asked permission to~     obtain a tumor sample. Depending on the location of the tumor, this may be done by: 1)~     withdrawing bone marrow through a small needle; 2) removing fluid from the chest or abdomen;~     3) removing a small tumor sample through a needle; or 4) removing the sample with a small~     incision into or around the tumor. These procedures will be done only if they are of low risk~     to the patient.~   "
271660|NCT00026650|"~     Background:~      -This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our~     patients, to continue to follow those who have been treated with radiotherapy at ROB and are~     not otherwise eligible for current active research protocols. it also provides a mechanism~     for the correlation and interpretation of disparatc data for research into the long term side~     effects and outcomes for a variety of disease entities and treatments, such as combined~     modality treatment, MoAb, PDT, radiation modifiers, intraoperative radiotherapy, etc.~      Objectives:~      -The objective of this protocol is to provide follow-up care for patients previously treated~     with radiotherapy in the Radiation Oncology Branch (ROB) in order to assess the late effects~     of treatment and the natural history of disease.~      Eligibility:~      -Patients who received radiation therapy at the NCI IRB who are long-term survivors and are~     not currently entered on an active research protocol.~      Design:~      -This is a natural history protocol that will provide follow-up care for Radiation Oncology~     Branch patients and will allow for appropriate long-term follow up care and evaluation,~     including NIH consultation services as required. It will be made clear to patients in the~     consent form, that data collected in their follow-up may be used anonymously for publications~     concerning the natural history of disease processes and long term effects of treatment.~   "
271661|NCT00026637|"~     To define the benefits of antidepressant treatment or cognitive behavior therapy on mood,~     function, and quality of life in persons with depression and refractory epilepsy.~   "
271662|NCT00026624|"~     The purpose of this study is to determine how safe it is to give patients a shot that has a~     mixture of a vaccine and dendritic cells (DCs), a special kind of immune cell, and how safe~     it is to give a shot of the vaccine alone.~      Current HIV vaccines have not been strong enough to give good immune responses. Research has~     shown that the immune response to a vaccine delivered by DCs is greater than the response~     without DC delivery. A5130 is a study that seeks to give good delivery of the vaccine to~     important immune cells of the body.~   "
271663|NCT00026611|"~     The purpose of this study is to see how many people respond to a smallpox vaccine when a sore~     forms where the shot was given.~      The world was declared free of smallpox in 1980. General routine vaccinations for smallpox~     were stopped in the U.S. in 1971. In 1976, the recommendation for routine vaccination of~     healthcare workers was also discontinued. The only people who presently receive this vaccine~     are people who work with vaccinia virus or monkeypox virus. Because the world was considered~     free of smallpox infections, this vaccine was no longer produced; there is a limited supply~     available in the United States.~      Because of the limited amount of Dryvax vaccine (vaccinia virus) against smallpox, this study~     will look at the ability to dilute the vaccine making more doses available in the event of a~     smallpox outbreak. The study seeks to characterize a strategy of vaccination against smallpox~     with various doses of Dryvax, followed by revaccination with the same dose, if required, in~     volunteers 18-32 years of age with a negative history of smallpox vaccination.~   "
271664|NCT00026598|"~     The purpose of this study is to investigate how changes in the brain associated with~     Parkinson's disease influence the control of motor and thinking speed. There is disagreement~     over whether patients with Parkinson's disease are slow in thinking as well as movement. This~     study may provide a new framework to explain the relationship between motor and cognitive~     aspects of human behavior and help to clarify the pathophysiology of Parkinson's disease.~      There are two parts to the study: behavioral tests and functional magnetic resonance imaging~     (fMRI). All participants will be asked about their medical history, have a physical~     examination, and complete a questionnaire. They must not take regular medications, including~     levodopa and dopamine agonists, for 8 hours prior to the study.~      The behavioral study involves computer-generated neuropsychological tasks, including hand~     movements, imagination of movements, and mental calculations. Response will be recorded and~     evaluated. Electrodes may be placed on the participant's skin to measure surface~     electromyogram (EMG).~      The fMRI study involves MRI scanning in which motor and thinking tasks are performed.~     Electrodes may be placed on the skin to monitor muscle activity.~      Thirty patients, ages 40 and up, with early-stage Parkinson's disease will be recruited.~     Sixty normal volunteers ages 21-75 will be included as well for comparison.~   "
271694|NCT00025714|"~     This study will collect brain tissue samples for research purposes from patients undergoing~     surgery to treat epilepsy. The standard surgical procedure for medically intractable epilepsy~     i.e., epilepsy that cannot be controlled with medicine requires removal of more brain tissue~     than is needed for diagnostic study. This extra tissue, which would otherwise be discarded,~     will be used for research purposes. In addition, a blood vessel in the scalp, called the~     superficial temporal artery, is also normally cut during surgery, and a piece of this vessel~     will be taken for research use.~      Patients 4 years of age or older who undergo surgery for medically intractable epilepsy may~     be eligible for this study.~      Brain tissue collected under this protocol will be used for studies of brain cells in other~     diseases and of serotonin receptors. Any remaining brain tissue will be frozen for use in~     future research. The superficial temporal artery will be used for comparison with carotid~     arteries (a neck artery that supplies the brain) from patients with blockage of this blood~     vessel.~   "
271665|NCT00026585|"~     The purpose of this study is to examine how the drug tamoxifen affects the brain in patients~     with bipolar I disorder.~      Bipolar Disorder (BD) is a severe, chronic, and often life-threatening illness for which safe~     and effective treatments are necessary. The mood stabilizing effects of lithium and valproate~     have revolutionized the treatment of patients with BD. However, a significant percentage of~     patients do not respond fully to these drugs, and the biochemical basis for the antimanic and~     mood-stabilizing actions of lithium and valproate is unclear. Both drugs inhibit protein~     kinase C (PKC). There is a need to investigate the efficacy of a direct PKC inhibitor in the~     treatment of acute mania. Tamoxifen is currently the only relatively selective PKC inhibitor~     available for human use.~      Participants in this study will be screened with a physical, psychiatric, and eye examination~     and blood and urine tests. Eligible participants will be hospitalized at the Clinical Center~     for at least 4 weeks. They will be tapered off all psychiatric medication and kept drug free~     for 2 to 7 days. They will also be put on a low-monoamine, low-caffeine diet. Participants~     will be randomly assigned to receive either tamoxifen or placebo (an inactive pill) for 3~     weeks. During this time, participants will have daily pulse and blood pressure measurements,~     several electrocardiograms (EKGs), and blood draws. Weight measurements will be taken at~     least twice during the study, and caffeine or dextromethorphan will be given at the beginning~     and end of the study to test how tamoxifen affects the way the body eliminates other~     medications. Participants will have a physical examination at the end of the study.~      At the end of this 4-week study, some participants may continue the study and will receive~     tamoxifen for an additional 3 weeks. At the conclusion of the study, participants'~     psychiatric status will be reassessed and long-term psychiatric treatment for their mood~     disorders will be arranged.~   "
271666|NCT00026559|"~     This study has several parts. One part will examine the influence of factors such as~     personality and past experience on reactions to unpleasant stimuli. Others will examine the~     effect of personality and emotional and attentional states on learning and memory.~      When confronted with fearful or unpleasant events, people can develop fear of specific cues~     that were associated with these events as well as to the environmental context in which the~     events occurred via a process called classical conditioning. Classical conditioning has been~     used to model anxiety disorders, but the relationship between stress and anxiety and~     conditioned responses remains unclear. This study will examine the relationship between cued~     conditioning and context conditioning . This study will also explore the acquisition and~     retention of different types of motor, emotional, and cognitive associative processes during~     various tasks that range from mildly arousing to stressful.~   "
271667|NCT00026546|"~     The purpose of this study is to determine how the brain controls motor activity in children~     with attention deficit hyperactivity disorder (ADHD).~      The inability to control one s behavior is an important symptom of many psychiatric~     illnesses. The stop signal paradigm which involves withholding a motor response to a go~     signal, has proved useful in assessing uncontrolled behavior in children with ADHD and other~     disorders. This study will use a stop signal paradigm in order to evaluate the ability of~     children with and without ADHD to control their motor behavior. A magnetic resonance imaging~     (MRI) scan will be used to study how the brain works during specific activities.~      This study will evaluate the stop signal paradigm in three groups of people: healthy~     children, children with ADHD, and healthy adults. This study comprises two sub-studies: a~     behavioral study in which participants perform simple activities and an MRI study.~      Participants will be asked to stop any over-the-counter medication 5 days before entering the~     behavioral or MRI study. Children with ADHD will be asked to stop taking medication for ADHD~     72 hours before the study. All participants will have a medical history and a psychiatric~     evaluation (for children, both parents and children provide information for the assessment).~     Participants in the MRI study will also have physical examinations and blood and urine tests.~     All children will undergo intelligence tests; and those with ADHD will have tests to confirm~     the diagnosis. The parents of child participants will complete an autism screening~     questionnaire.~   "
271668|NCT00026065|"~     Hypertension, present in more than 50 million Americans, increases the risk of cardiovascular~     disease and its associated complications. More persons are turning to alternative medicine to~     deal with their health problems. Biofeedback may reduce blood pressure and/or allow the~     reduction of antihypertensive medications in some patients, while having no adverse effects.~     Yet biofeedback therapy is time-intensive and technician-intensive. Therefore, it is critical~     to be able to predict which patients with essential hypertension are most likely to lower~     his/her blood pressure using these techniques. This research proposes to test three different~     means of predicting whether a hypertensive subject will or will not be successful in lowering~     his/her blood pressure using biofeedback. Sixty hypertensive subjects will be studied over a~     three-year period. The results of this study will enable those caring for hypertensive~     persons to recommend biofeedback in an individualized way, thereby promoting adherence.~   "
271669|NCT00026052|"~     This study will examine the safety and effectiveness of the drug riluzole (Rilutek®~     (Registered Trademark)) for short-term treatment of depression symptoms, such as depressed~     mood, psychomotor retardation, and excessive sleeping. Despite the availability of a wide~     range of antidepressant drugs, studies indicate that 30 to 40 percent of patients with major~     depression do not respond to first-line antidepressant treatment with drugs such as~     fluoxetine, upropion, venlafaxine and others. Riluzole, which is approved by the Food and~     Drug Administration (FDA) for amyotrophic lateral sclerosis (ALS), causes chemical changes in~     the brain that may also have antidepressant properties.~      Patients between 18 and 70 years of age with major depressive disorder without psychotic~     features may be eligible for this 2-stage 7-week study. Candidates will be screened with a~     medical history and physical examination, including an electrocardiogram (EKG), blood and~     urine tests, and a psychiatric evaluation. A~      blood or urine sample will be tested for illegal drugs.Women of childbearing potential will~     have a pregnancy test.~      Participants will complete stage 1 of the study, which lasts 1 week, and may then continue~     with stage 2 for an additional 6 weeks. At the start of the study, patients will be tapered~     off all psychiatric medicines and will begin treatment with a placebo (a sugar pill~     formulated to look like the active drug). At some point, they will be switched from placebo~     to riluzole. In addition, participants will undergo the following procedures:~        -  Physical examination and electrocardiograms (EKG) at the beginning and end of the study,~          with vital signs (temperature, blood pressure and heart rate) checked daily~        -  Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to~          assess treatment response~        -  Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects~      At the end of the study, participants' psychiatric status will be reassessed and appropriate~     long-term psychiatric treatment arranged.~      Patients, ages 18 to 70 with a diagnosis of major depression without psychotic features, will~     in this pilot study (single arm, single blind) receive riluzole (50-200 mg/day) for a period~     of 6 weeks. Acute efficacy will be determined by demonstrating a greater response rate using~     specified criteria.~      Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks~     of acute riluzole treatment. Therefore, if 7/22 patients or greater have greater than 50%~     improvement on the primary efficacy measure, then based on statistically guidelines from the~     Optimal Two Stage Design for Clinical Trials, a controlled trial would be indicated to~     scientifically confirm the signal observed in the single arm trial.~   "
271670|NCT00026039|"~     To determine if estrogen hormone replacement therapy reduces the risk of stroke or death in~     postmenopausal women who have already had stroke or a transient ischemic attack (TIA).~   "
271750|NCT00021775|"~     The purpose of this study is to set up a system for doing research on HIV prevention in~     various parts of the world.~      In order to plan large, long-term studies on the prevention of HIV in different areas of the~     world, it is necessary to get certain information first. It is important to know about the~     rate of HIV infection and how to get people to enroll for any future studies. This study will~     be done at 4 study locations.~   "
271671|NCT00026026|"~     The congenital absence of teeth, commonly referred to as hypodontia or tooth agenesis, is a~     common developmental anomaly of human dentition that affects approximately 20% of the~     population. Although new genetic and molecular approaches in humans and mice have increased~     our understanding of the molecules that control tooth patterning (number, position, shape and~     size), the precise nature of the genes involved in hypodontia in humans is poorly understood.~     Hence, understanding the molecular basis for missing teeth is an issue of paramount~     importance that is both timely and significant to the practice of dentistry. So far, only two~     genes have been associated with non-syndromic familial tooth agenesis: MSX1 and PAX9.~     Substitution mutations in the homeodomain region of MSX1 were linked to premolar agenesis~     while an insertion mutation in the paired box domain of PAX9 was shown to be responsible for~     molar oligodontia.~      The long-term goals of this research are to elucidate the molecular pathology of human tooth~     agenesis, in particular, to evaluate whether genes other than MSX1 and PAX9 (locus~     heterogeneity) are involved. Alternatively, as in the case of MSX1, it will be interesting to~     know whether allelic variations, different mutations in these genes, are associated with~     tooth agenesis. We propose to study a potentially large kindred that report the developmental~     absence of several posterior teeth. The fundamental hypothesis to be tested states that the~     gene responsible for the congenital absence of molar teeth in this kindred is a critical~     element in the genesis of molars. The specific goals are to perform linkage analysis followed~     by direct sequencing of PCR products to identify the gene and to characterize the nature of~     the underlying defect. Identifying the underlying gene defect in this family affected by~     tooth agenesis will add new knowledge to our understanding of the pathogenesis of this defect~     and will provide the basis for future studies.~   "
271672|NCT00026013|"~     The purpose of this study is to evaluate the effects of a common herbal remedy, St. John's~     Wort, on the effectiveness of birth control pills. St. John's Wort has recently been shown to~     increase metabolism of some drugs. If it could increase metabolism of oral contraceptives as~     well, it may increase the risk of contraceptive failure and unintended pregnancy. Study~     participants will be evaluated for risk of ovulation on oral contraceptives before and during~     simultaneous therapy with St. John's Wort.~   "
271673|NCT00026000|"~     This study will investigate the brain areas that are activated by vocal and motor tics in~     patients with Tourette's syndrome and other tic disorders. Tics are involuntary repetitive~     movements similar to voluntary movements. They may be simple, involving only a few muscles or~     simple sounds, or complex, involving several groups of muscles in orchestrated bouts. This~     study will involve only simple motor tics, such as eye blinking, nose wrinkling, facial~     grimacing and abdominal tensing, and simple vocal tics, such as throat clearing, sniffing and~     snorting.~      Healthy normal volunteers and patients between 14 and 65 years of age with simple motor or~     vocal tics may be eligible for this study.~      Participants will have a brief medical history and physical examination and magnetic~     resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to produce~     images. For the procedure, the subject lies on a table that is moved into a cylindrical~     chamber containing a strong magnet. Earplugs are worn to muffle the loud thumping sounds made~     by electrical switching of the radio frequency circuits and protect against temporary hearing~     impairment.~      During the scan, normal volunteers will be asked to make simple movements or sounds designed~     to imitate tics, such as raising eyebrows, blinking or coughing. Patients with tic disorders~     will have two parts to the scanning session. First they will relax and allow tics to occur~     spontaneously, then they will be asked to imitate a specific tic when there is no urge to~     tic.~      Patients and healthy subjects will have electromyography (EMG) to record the timing of the~     voluntary movements and tics. For this procedure, several pairs of small, saucer-like~     electrodes are attached to the skin with a gel or paste. Electric signals from the electrodes~     are amplified and recorded on a computer. A microphone may be placed near patients to record~     any vocal tics. A video camera may also be used to record the tics.~   "
271674|NCT00025987|"~     This study will evaluate the effectiveness of a specially designed head-neck cooling system~     for way lowering the body's central, or core, temperature and cooling the brain. Brain~     cooling has an effect on stopping seizure discharges in the brain as well as the seizures~     themselves. If this system works to cool the brain, a similar study may be tried in patients~     with epilepsy.~      Normal volunteers 21 years of age and older who have no medical or neurological condition and~     do not use any medications may be eligible for this study. Candidates will be screened with~     an interview. Women will have a pregnancy test. Those enrolled will be hospitalized twice for~     overnight stays, with the admissions 2 to 3 days apart.~      Participants will have a medical history, physical and neurological examinations,~     electroencephalogram (EEG) and electrocardiogram (EKG). Then, electrodes will be attached to~     their scalp, forearm and calf to measure temperatures in those locations. Intestinal (core)~     temperature will be measured with a temperature-sensing pill, which will be swallowed~     earlier), and a hand-held infrared thermometer will be used to measure temperatures from the~     ear canal, face, head, arms legs, and abdomen. Electrodes on the scalp will also measure~     changes in blood volume in the brain for a study of brain blood flow. Subjects will be seated~     in a comfortable chair and fitted with the cooling system, a portable unit with a circulating~     coolant. Cooling will last 30 minutes for the first session and 60 minutes for the second.~     Participants will be monitored for at least 30 minutes after each session to track~     temperature changes and have a post-cooling EEG recording.~   "
271675|NCT00025974|"~     The purpose of this study is to examine how certain brain chemicals work in patients with~     Panic Disorder (PD) and Post-Traumatic Stress Disorder (PTSD) with and without major~     depressive disorder (MDD).~      Brain chemicals that regulate emotion, anxiety, sleep, stress hormones, and other body~     functions bind to serotonin (5-HT1A) and benzodiazepine (BZD) receptors. Evidence suggests~     that 5-HT1A and BZD receptor function is abnormal in patients with PD, PTSD, and depression.~     This study will use positron emission tomography (PET) scans to examine BZD and 5-HT1A~     receptor binding potential in patients with PD and patients with PTSD with and without~     co-morbid MDD, as well as in healthy volunteers. This study will also determine the effects~     of the stress hormone cortisol on 5-HT1A and BZD receptors.~      The current emotional state and psychiatric, medical, and family history of potential~     participants will be evaluated during an initial telephone interview. After entering the~     study, participants will be asked questions about general mood, degree of nervousness, and~     behavior. A physical examination, an electrocardiogram (EKG), and tests of intelligence and~     cognition will be given. Urine, blood, and saliva samples will be taken. Women will be given~     pregnancy tests and tests to determine menstrual phase and time of ovulation. All volunteers~     will undergo magnetic resonance imaging (MRI) and PET scans of the brain.~   "
271676|NCT00025935|"~     This study seeks to learn more about the symptoms of severe mood dysregulation in children~     and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD)~     display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia,~     distractibility, hyperactivity) and extreme responses to frustration (such as frequent,~     severe temper tantrums). Researchers will describe the moods and behaviors of children with~     these symptoms and use specialized testing and brain imaging to learn about the brain changes~     associated with this disorder.~   "
271807|NCT00007319|"~     The intima-media thickness (IMT) test is a low cost, non-invasive way to measure the~     thickness of the carotid artery (the large artery in the neck). The purpose of this study is~     to compare the thickness of the carotid artery among HIV infected adults taking protease~     inhibitors (PIs), HIV infected adults not taking PIs, and HIV uninfected adults, and to~     examine how the thickness may change over time.~   "
271677|NCT00025922|"~     This 2-part study will examine 1) the immune response to influenza (flu) vaccine in~     HIV-infected patients, and 2) the effect of flu vaccine on HIV viral loads. Earlier studies~     have shown that people with HIV infection do not respond as well to flu vaccine as healthy~     subjects; that is, they don't make as many antibodies in response to the vaccine. Also,~     studies done before the use of HAART (highly active antiretroviral treatment) have shown that~     HIV levels increase for a period of time after flu vaccination. One small study showed a~     small brief increase in HIV even in patients taking HAART. The current trial will examine~     whether the flu vaccine does, in fact, cause an elevation in viral load and whether this~     increase is harmful or indicates a better response to the vaccine.~      HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be~     eligible for part1of this study. (Healthy volunteers will serve as control subjects to make~     sure the flu vaccine stimulates production of enough antibody to protect against the flu).~     Part 2 will include only HIV-infected patients with fewer than 50 copies per milliliter of~     HIV. Patients in both parts of the study must have been receiving HAART (consisting of at~     least two nucleoside reverse transcriptase inhibitors plus a non-nucleoside reverse~     transcriptase inhibitor or a protease inhibitor) for at least 3 months before enrollment in~     the study. Candidates will be screened with a medical history and blood tests, including HLA~     testing (a genetic test of immune system markers). Women who are able to have children will~     have a pregnancy test. Pregnant women are excluded from the study.~      Participants will undergo the following procedures:~        -  Part 1 - Immune Response to Flu Vaccine~      In the first of two visits, participants will have blood drawn for flu antibody levels before~     vaccination and, in HIV-infected patients, measures of T cell count and viral load. They will~     then receive the flu vaccine. Blood will be drawn at a second visit 28 days later for the~     same tests.~        -  Part 2 - Effect of Flu Vaccine on Viral Levels~      Participants will be randomly assigned to receive the flu vaccine either at the beginning of~     their enrollment in the study (immediate) or 3 weeks after enrollment (deferred). Those in~     the immediate group receive the flu vaccine on the first day (day 0) and have blood drawn on~     days 0, 3, 7, 10, 14, 17, 21, 24, 28, 31, 35, 38 and 42. Those in the deferred group are~     vaccinated on day 21 and have blood drawn on days 0, 3, 7, 10, 14, 17, 21, 24, 28, 31, 35,~     38, 42 and 49. The blood is tested for viral load, CD4 cell counts and antibody levels.~   "
271678|NCT00025909|"~     This study will evaluate the effects of intermittent short cycles of HAART (highly active~     antiretroviral therapy) for treating HIV infection. HAART is a multi-drug regimen that is~     very effective in suppressing HIV and perhaps slowing or halting progression to AIDS.~     However, the treatment has significant drawbacks: it cannot completely rid the body of virus;~     long-term therapy carries a risk of toxicity (harmful side effects); and the regimen is~     difficult to comply with because many pills and capsules must be taken daily. When patients~     stop taking HAART, their HIV levels climb again. This study will see if giving HAART in short~     cycles of 7 days on, 7 days off, can keep viral levels low while maintaining CD4+ T cell~     counts.~      HIV-infected people age 18 or older who are receiving HAART and have a viral load of less~     than 50 copies/ml and a CD4+ T cell count of at least 175 cells/mm3 may be eligible for this~     study. Candidates will be screened with a medical history and physical examination, blood and~     urine tests, and possibly a chest X-ray and electrocardiogram. Women of childbearing~     potential will have a pregnancy test.~      Participants will be randomly assigned to either continue their current medication regimen or~     to take HAART in intermittent cycles of 7 days off, 7 days on. Patients will continue~     treatment for 72 weeks or until viral levels increase or CD4+ T cell counts decline to a~     level of concern.~      Upon entering the study, patients will have blood tests to monitor the amount of virus in the~     blood, CD4+ T cell count, viral resistance to HAART medications, side effects of the drug,~     and immune response to HIV in the test tube. They will have clinic visits for a history,~     physical examination and blood draws every month for 12 months. At that time, depending on T~     cell counts and viral load, the number of visits may be reduced, but never less frequently~     than every other month.~      Patients will also undergo leukapheresis-a procedure for collecting quantities of white blood~     cells-every 3 to 4 months while on the study. For this procedure, whole blood is collected~     through a needle in an arm vein (similar to donating blood). The blood is circulated through~     a cell separator where the white cells are removed, and the rest of the blood (plasma, red~     cells and platelets) is returned through the same needle or through a second one in the other~     arm. The collected white cells are used for special studies on the level and function of T~     cells and to detect hidden virus.~   "
271679|NCT00025896|"~     Pompe disease is caused by a deficiency of a critical enzyme in the body called acid alpha~     glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored~     form of sugar) within specialized structures called lysosomes. In infants with severe cases~     of Pompe disease (called Classical Infantile Pompe disease), an excessive amount of glycogen~     accumulates and is stored in various tissues, especially heart, skeletal muscle, and liver,~     which prevents their normal function. This study being conducted to evaluate the safety and~     effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme~     replacement therapy for Pompe disease. Patients diagnosed with Classical Infantile Pompe~     disease who have a small, but inactive, amount of natural GAA enzyme present in their bodies~     (called Cross-Reacting Immunologic Material-Positive or CRIM (+) patients), will be~     studied.~   "
271680|NCT00027222|"~     The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to test the~     hypothesis that earlier treatment in carefully selected cases will result in an overall~     better visual outcome than treatment at the conventional CRYO-ROP threshold point in the~     disease.~   "
271681|NCT00025883|"~     This study will evaluate the safety and effectiveness of leptin replacement therapy in~     patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss~     of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin~     deficiency usually causes high blood lipid (fat) levels and insulin resistance that may lead~     to diabetes. Patients may have hormone imbalances, fertility problems, large appetite, and~     liver disease due to fat accumulation.~      Patients age greater than or equal to 6 months with significant lipodystrophy may be eligible~     for this study. Participants will be admitted to the NIH Clinical Center for 10 days for the~     following studies before beginning 12 months of leptin therapy:~        -  Insulin tolerance test~        -  Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies.~        -  Fasting blood tests~        -  Resting metabolic rate~        -  Magnetic resonance imaging of the liver and other organs, and of muscle and fat.~        -  Pelvic ultrasound in women to detect ovarian cysts.~        -  Estimation of body fat~        -  Oral glucose tolerance test~        -  Intravenous glucose tolerance test~        -  Appetite level and food intake~        -  Hormone function tests~        -  Questionnaires to assess activity and mood~        -  24-hour urine collections~      Additional studies may include blood tests for genetic studies of lipodystrophy, a muscle~     biopsy to study muscle proteins involved in regulating energy expenditure before and after~     leptin replacement, and examination of a surgical specimen (if available) to study molecules~     that may be involved in energy storage and use.~      When the above tests are completed, leptin therapy begins. The drug is injected under the~     skin twice a day for 4 months and then once a day, if feasible. The dose is increased at the~     1- and 2-month visits. Follow-up visits at 1, 2, 4, 6, 8 and 12 months after therapy starts~     include a physical examination, blood tests and a meeting with a dietitian. At the end of 12~     months, all baseline studies described above are repeated. Patients record their symptoms~     weekly throughout the study. Those with diabetes measure their blood glucose levels daily~     before each meal and at bedtime.~   "
271695|NCT00025701|"~     This study will examine how the brain operates during execution and control of voluntary~     movement and what goes wrong with these processes in disease. It will use~     electroencephalography (EEG) and electromyography (EMG) to compare brain function in normal~     subjects and in patients with focal hand dystonia. In dystonia, involuntary muscle movements,~     or spasms, cause uncontrolled twisting and repetitive movement or abnormal postures. Focal~     dystonia involves just one region of the body, such as the hand, neck or face.~      EEG measures the electrical activity of the brain. The activity is recorded using wire~     electrodes attached to the scalp or mounted on a Lycra cap placed on the head. EMG measures~     electrical activity from muscles. It uses wire electrodes placed on the skin over the~     muscles.~      Adult healthy normal volunteers and patients with focal hand dystonia may be eligible for~     this study. Patients will be selected from NINDS's dystonia patient database.~      Participants will sit in a semi-reclining chair in a darkened room and be asked to move~     either their right index finger, right foot, or the angle of their mouth on the right side at~     a rate of one movement every 10 seconds. Brain and muscle activity will be measured during~     this task with EEG and EMG recordings.~   "
271682|NCT00025870|"~     This study will provide medical evaluations for patients with known or suspected metabolic~     and genetic disorders. It will allow NICHD investigators and trainees experience in~     diagnosing, managing, and treating patients with metabolic and genetic disorders who may not~     be eligible for an active NIH research trial. Participants in this protocol will only have~     tests and procedures used in the standard practice of medicine; there will be no experimental~     tests or treatments. Patients who are found eligible for an active research protocol will be~     offered participation in that study. The medical evaluations in this trial may uncover new~     disease processes that prompt new research initiatives.~      People of all ages with a suspected or diagnosed genetic or metabolic condition may be~     eligible for this study. In addition, children with unexplained developmental delay,~     deafness, dysmorphism, congenital malformations, acidosis, failure to thrive, feeding~     problems, short stature, birth defects, and other syndromes of unknown cause may qualify.~      Participants will have a medical history, including a family history, with possible review of~     previous medical records, and a physical examination. Other procedures may include:~        -  Consultation with medical specialists.~        -  Hearing and/or vision tests.~        -  Imaging studies, such as X-rays, ultrasound and magnetic resonance imaging (MRI).~        -  Blood drawing Blood samples (2 to 4 tablespoons from adults and 1 to 2 tablespoons from~          children) may be used for routine lab tests, genetic study, and other research purposes.~        -  Cheek swab DNA may be obtained by a cheek swab. A small brush is rubbed against the~          inside of the cheek to collect some cells.~        -  Skin biopsy Under local anesthetic, a small circle of skin (about 1/8-inch) is removed~          with a sharp cutting instrument similar to a cookie cutter.~        -  Muscle biopsy Under local anesthetic, a small piece of muscle tissue is removed to aid~          in diagnosis.~      Participants will undergo only diagnostic procedures that are clinically indicated; that is,~     only tests needed to confirm or rule out a diagnosis will be done. Tissue samples collected~     for diagnostic purposes may also be used to obtain DNA for genetic studies and to establish~     cell lines (cells grown in the laboratory to be maintained indefinitely) for future research.~      The results of the medical evaluation may indicate whether or not the participant has the~     disease that runs in the family (if a genetic disorder is indeed confirmed). Unless he or she~     requests otherwise, the subject (and parent in the case of a minor) will receive counseling~     regarding the test results. The implications of a positive test result will be explained,~     specifically, the participant s risk of having the disease, and the risk of passing the~     condition on to offspring.~   "
271683|NCT00025857|"~     The purpose of this study is to use brain imaging technology to examine the brain activity of~     adolescents with post-traumatic stress disorder (PTSD) and/or major depressive disorder (MDD)~     before and after treatment.~      Adults with PTSD or MDD exhibit abnormalities in the structure and function of certain parts~     of the brain. Although PTSD and MDD are psychiatric disorders that often emerge in childhood,~     the relationship between these disorders and brain structures has not been thoroughly studied~     in adolescents with the disorders. This study will use functional magnetic resonance imaging~     (fMRI) to study the parts of the brain that are involved in PTSD and MDD in adolescents.~      Adolescents with PTSD and/or MDD will be enrolled along with healthy adolescents with or~     without a history of abuse. Healthy adults will also be enrolled. Participants will be~     screened with a physical examination; blood tests; and interviews about mood, general degree~     of nervousness, and behavior. Adolescents and their parents will be interviewed separately~     and together. Following the interviews, participants will undergo psychological tests.~     Participants with PTSD and/or MDD will have two weekly sessions of talk therapy. Participants~     who continue to experience PTSD or MDD symptoms after the talk therapy may continue the talk~     therapy alone, begin treatment with fluoxetine (Prozac ) alone, or begin fluoxetine in~     addition to the talk therapy. Participants who take fluoxetine will have blood collected~     before treatment and 8 weeks after treatment has begun. If participants do not respond to the~     treatment, the treatment will be stopped and the participants will be offered another~     treatment. Participants who respond to treatment will continue treatment at NIH until a~     referral to an outside physician is made. Depending on the experiment in which they are~     enrolled, participants will undergo one or four MRI scans. Participants who will have four~     MRI scans will undergo the scans on separate days. During the MRI, participants will complete~     tasks on a computer. Saliva samples will be collected before and after the scans.~     Participants with PTSD and/or MDD will collect their saliva one or two days before the MRI~     scan.~   "
271684|NCT00025844|"~     The purpose of this study is to use a computer-generated virtual reality environment to study~     fear conditioning. Fear conditioning is used to explore the causes and persistence of anxiety~     and anxiety disorders.~      When confronted with fearful or unpleasant events, people can develop fear of specific cues~     that were associated with these events as well as to the environmental context in which the~     events occurred via a process called classical or aversive conditioning. Advances in~     computer-generated visual stimulations could facilitate the design of new aversive~     conditioning studies. This study will develop a virtual reality environment to examine human~     contextual fear conditioning in the laboratory. During the procedure, moderately painful~     stimuli will be administered. Participants in this study will be screened with a medical~     history, physical examination, psychiatric evaluation, and hearing test. Participants will~     wear headphones and special goggles that will enable them to view a virtual reality~     environment. Measures will be taken during the study to see how the brain adapts to~     environmental stimuli.~   "
271685|NCT00025831|"~     This study will collect biological samples-buccal cells, blood sample, skin sample-to be used~     in developing and testing laboratory methods for measuring and analyzing genes. Such methods~     can be used for research on identifying genetic factors that may affect a person's cancer~     risk.~      All individuals age 21 and older may participate in this study. Participants will provide one~     or more of the following samples:~        -  Buccal (mouth) cells - obtained by swishing a small amount of mouthwash in the mouth or~          by swabbing or bushing the inside of the cheek with a swab or brush.~        -  Blood - obtained by pricking the finger and collecting the drops or by blood drawing~          through a needle placed in an arm vein.~        -  Skin - obtained by a punch biopsy on the inner upper arm. For this procedure, the skin~          is anesthetized and a small piece of skin is removed with a sharp instrument similar to~          a cookie cutter. The wound is then covered and held together with a sterile bandage. A~          small scar, approximately 1/8-inch long, will be left.~      Most participants will be asked to provide only a buccal sample; blood and/or skin samples~     will be requested from a few participants. The blood and skin samples may be used to grow~     cell lines; that is, to make them grow indefinitely for research uses.~   "
271686|NCT00025818|"~     A six-month clinical research trial to evaluate the effectiveness of an investigational~     medication for the treatment of dry eye syndrome in patients that have been diagnosed with~     moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or~     older.~   "
271696|NCT00024999|"~     This study will examine how the brain operates during execution and control of voluntary~     movement and what goes wrong with these processes in disease. It will use~     electroencephalography (EEG) and electromyography (EMG) to compare brain function in normal~     subjects and in patients with-a disorder affecting patients with stroke and other brain~     lesions. These patients have problems with timing, sequence and spatial organization of~     certain types of movements.~      EEG measures the electrical activity of the brain. The activity is recorded using wire~     electrodes attached to the scalp or mounted on a Lycra cap placed on the head. EMG measures~     electrical activity from muscles. It uses wire electrodes placed on the skin over the~     muscles.~      Adult healthy normal volunteers and patients with ideomotor apraxia with a single left brain~     lesion may be eligible for this study.~      Study participants will be asked to make certain movements with their arms or hands, such as~     waving and using scissors. Brain and muscle activity will be measured during these tasks with~     EEG and EMG recordings. Patients may be asked to repeat these tests over time as their~     condition changes (such as during recovery from a stroke) to gain information about the~     recovery process.~   "
271996|NCT00002352|"~     The purpose of this study is to see if lobucavir is a safe and effective treatment for~     cytomegalovirus in patients with AIDS.~   "
271687|NCT00025805|"~     This study will examine the effectiveness of G-CSF in treating patients with Crohn's~     disease-a long-term recurring inflammation of the small and large intestine. Patients may~     have swelling and bleeding of the intestinal lining, which can lead to infection and~     abdominal pain, weight loss, fever, diarrhea, bloody stools, fistula (connections between the~     skin and intestine), intestinal blockages, and abscesses. Although there are various~     treatments for Crohn's disease, many patients continue to have inflammation that is difficult~     to control or severe side effects from the medications. G-CSF is an approved drug that is~     used to increase white blood cell counts. Other cells, immune cells, exposed to G-CSF can~     develop a specific immune action-a Th-2 response-that decreases the inflammatory response in~     Crohn's disease-a Th-1 response.~      Patients 18 years of age or older who have had mild to moderately severe Crohn's disease for~     at least 4 months may be eligible for this study. Candidates will be screened with a medical~     history and possible review of medical records, physical examination, blood tests,~     electrocardiogram (EKG), urine and stool analyses and, for women, a pregnancy test. They will~     fill out a Crohn's Disease Activity Index questionnaire daily for 7 days and an Inflammatory~     Bowel Disease questionnaire.~      Participants will have G-CSF therapy. Before starting therapy, they will have a series of~     pre-treatment tests, including a colonoscopy and leukapheresis. Colonoscopy is an examination~     of the colon. For the procedure, patients are given a medication to lessen anxiety and any~     discomfort. An endoscope-a lighted flexible tube-is inserted into the rectum, allowing~     examination of the extent of inflammation. The endoscope can also be used to take pictures of~     the colon and extract tissue samples for testing (biopsy). Leukapheresis is a procedure for~     collecting quantities of white blood cells. Whole blood is collected through a needle placed~     in an arm vein and circulated through a machine that separates it into its components. The~     white cells are removed, and the rest of the blood is returned to the body, either through~     the same needle used to draw the blood or through another needle placed in the other arm.~      After the colonoscopy and leukapheresis, patients receive G-CSF injections every day for 29~     days. The patient or a caregiver, such as a family member, will be taught to give the~     injections. Blood samples will be collected on treatment days 4, 8, 11 and 15, and a physical~     examination and interview, blood tests and a stool exam will be done once a week. Patients~     will have a repeat colonoscopy and leukapheresis 24 hours after the last treatment dose (day~     29).~      After the 29-day treatment, patients will be followed in the clinic as follows:~        -  Week 4 after treatment - physical exam and interview, routine blood work and stool exam~        -  Week 8 - interview and blood work~        -  Week 16 - interview, blood work and stool exam~        -  Week 24 - physical exam and interview, blood work, stool exam and colonoscopy~   "
271688|NCT00025792|"~     The purpose of this study is to examine the safety and effectiveness of the drug pramipexole~     given in combination with lithium or divalproex for the short-term treatment of acute~     depression in patients with bipolar disorder.~      Bipolar disorder is a severe, chronic, and often life-threatening illness. Treatments for~     acute unipolar depression have been extensively researched. However, despite the availability~     of a wide range of antidepressant drugs, a significant proportion of depressed patients fail~     to respond to first-line antidepressant treatment. Novel and improved therapeutics for~     bipolar depression are needed. This study will evaluate the antidepressant properties of~     pramipexole.~      This study will be conducted in three phases. Phase 1 is a 14-day washout period in which~     participants will be tapered off all their psychiatric medicines except divalproex or~     lithium. Participants will also be asked to adhere to a low caffeine and low monoamine diet.~     During Phase 2, participants will be randomly assigned to receive either pramipexole or~     placebo (an inactive pill) for 6 weeks. Participants who respond to treatment will be given~     either open-label pramipexole or another clinical treatment.~      Participants will be screened with a medical history, physical examination, electrocardiogram~     (EKG), blood and urine tests, and a psychiatric evaluation. Women of childbearing potential~     will have a pregnancy test. Participants will have a physical exam and EKG at study entry and~     study completion. Blood will be drawn at various times throughout the study. Pulse and blood~     pressure measurements will be taken daily. Weekly interviews will be conducted. Participants~     and a control group of healthy volunteers will undergo positron emission tomography (PET) and~     magnetic resonance imaging (MRI) scans of the brain.~   "
271689|NCT00025779|"~     This study will evaluate the efficacy and safety of methylphenidate for treating~     hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with~     Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and~     Drug Administration for the treatment of children and adolescents with Attention Deficit~     Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD~     symptoms in PDD are limited. Children and adolescents who do not show a positive response to~     methylphenidate will be invited to participate in a pilot study of the non-stimulant~     medication guanfacine (Tenex).~   "
271690|NCT00025766|"~     The purpose of this study is to evaluate arterial patency and left ventricular ejection~     fraction by examining angiographic data one year following a heart attack and treatment with~     late revascularization.~   "
271691|NCT00025753|"~     Several complications have become prevalent in people living with HIV/AIDS, including~     increased blood sugar, increased blood fats and cholesterol, and fat tissue redistribution.~     The causes of these complications are not well understood and effective treatments have not~     been identified. We propose to test the efficacy and safety of 2 treatments for these~     complications in people living with HIV/AIDS: aerobic, weight lifting exercise training, and~     a new insulin-sensitizing agent called rosiglitazone (Avandia). Exercise and rosiglitazone~     have been effective and moderately safe when used in HIV-seronegative people with diabetes,~     but a specific trial is needed to test efficacy and safety in people living with HIV/AIDS.~   "
271692|NCT00025740|"~     Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that follows exposure to an~     extremely traumatic stressors. PTSD is associated with serious symptoms. While numerous~     approaches have been used to treat PTSD, these treatments have several limiting factors. This~     study will evaluate a combination of the drugs clonazepam and paroxetine for the treatment of~     PTSD symptoms.~      The main goal of treatment in patients with PTSD is to significantly reduce symptom severity~     and improve functioning. While numerous approaches have been used to treat PTSD, these~     treatments are limited by variable response rates, up to a 6-week lag period before clinical~     response, and sub-optimal side effect profile, including possible worsening of anxiety and~     insomnia prior to clinical response. The proposed study will examine whether combined~     treatment with a benzodiazepine (clonazepam) and a selective serotonin reuptake inhibitor~     (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second~     goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until~     the end of the study, despite tapering off the benzodiazepine at the midpoint of the study.~     The safety and tolerability of a combination of paroxetine and clonazepam will be compared to~     paroxetine and placebo (an inactive pill) in the treatment of PTSD.~      Participants in this study will be randomly assigned to receive either paroxetine plus~     clonazepam or paroxetine plus a placebo for 12 weeks. Participants will have weekly clinic~     visits for the first 4 weeks of the study and every other week for the last 8 weeks. Symptoms~     of PTSD, anxiety, and depression will be evaluated and drug side effects will be noted during~     the follow-up visits.~   "
271693|NCT00025727|"~     The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV)~     versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors~     (RTIs), in patients who have taken anti-HIV drugs without success.~   "
271697|NCT00024986|"~     This study will test the safety, side effects and antiviral activity of different doses of~     tenofovir DF in children and adolescents with human immunodeficiency virus (HIV) infection.~     Tenofovir DF belongs to a group of drugs called nucleotide analog reverse transcriptase~     inhibitors. These drugs prevent the virus from replicating (making more copies of itself).~      HIV becomes resistant to many drugs used to fight the virus and these drugs become~     ineffective. In laboratory tests, tenofovir DF has remained effective against HIV longer than~     other anti-HIV medicines, and when resistance does develop, the virus may still be sensitive~     to other drugs.~      HIV-infected children between the ages of 4 and 18 years who weigh at least 10 kg (22 pounds)~     may be eligible for this study. They must be able to receive antiretroviral therapy and have~     completed at least two previous antiretroviral courses of treatment without benefit.~      Upon entering the study, participants will have physical, eye and neuropsychiatric~     examinations, blood tests, including tests to determine what anti-HIV drugs the patient is~     resistant to, an echocardiogram (echo), electrocardiogram (EKG), chest X-ray, head CT scan,~     skin tests, and special tests to examine the bones. These physical exams and tests will be~     repeated throughout the study to determine changes in health.~      Participants will continue their current anti-HIV therapy for 2 weeks and then stop all~     medicines for a 1-week 'washout' period. After the washout period, patients will begin taking~     tenofovir DF. For the first 2 days on the drug, a small blood sample (1/2 teaspoon) will be~     collected 11 times over a 48-hour period through. A heparin lock (a tube kept in place in a~     vein) may be put in place to avoid multiple needle sticks. Blood samples will be collected~     for another 4 days to measure how well tenofovir DF alone works against HIV before other~     drugs are added to the treatment regimen. After these first 6 days, at least two other~     anti-HIV drugs will be added. They will be selected based on the results of the earlier blood~     tests for resistance and on the child's medication history.~      After 3 days of combination therapy, patients will continue therapy on an outpatient basis.~     They will be seen in the clinic every 4 weeks at the start of the study and then every 12~     weeks for physical exams, lab tests and other procedures as needed. The study will last~     approximately 48 weeks. Patients who benefit from therapy may be able to continue to receive~     tenofovir DF from the drug company sponsor or as part of another study, or the protocol for~     this study may be amended to lengthen the treatment period.~   "
271698|NCT00024960|"~     This study will use positron emission tomography (PET) to examine the role of the chemical~     messenger dopamine in stuttering. It will measure and compare the number of dopamine~     receptors and the amount of dopamine released in the brains of stutterers with that of normal~     volunteers. The results may provide information about how drugs that block dopamine's effect~     might work to enable fluent speech.~      Healthy normal volunteers and people with developmental stuttering between the ages of 18 and~     55 may be eligible for this study. Candidates will be screened with a medical history and~     possibly a physical examination and laboratory tests.~      Participants will have a hearing test and cognitive function tests to measure speech,~     language, memory and visual skills. In addition, they will undergo the following procedures:~        -  PET scanning to measure brain blood flow and dopamine distribution in the brain. PET~          uses radioactive materials to show cellular activity in specific tissues of the body.~          Before starting the procedure, a thin plastic tube (intravenous, or IV line) is placed~          in a vein in each arm of the subject and a special plastic mask is molded to the face.~          (The mask is used to insure that the position of the head does not change during the~          scan.) For the scan, the subject lies on a bed that is positioned into the scanner. A~          preliminary transmission scan is done to make necessary measurements and adjustments.~          Following this scan, 10 injections of radioactive water are given through an IV line.~          During these injections, the subject performs a series of speech tasks-such as singing,~          telling a story, or reciting nursery rhymes-that will elicit either fluent speech or~          stuttering. A special camera detects the radiation emitted and produces images of brain~          blood flow during stuttering and normal speech. Next, raclopride (a radioactive material~          that attaches to dopamine receptors on the cell surface) is given through an IV line and~          more pictures of the brain are taken. Fifty minutes after the raclopride injection,~          amphetamine-a drug that increases brain dopamine levels-is injected through the other IV~          line and more pictures are taken to show dopamine distribution in the brain. Fifty~          minutes after the amphetamine infusion, the IV lines are removed.~        -  Magnetic resonance imaging (MRI) of the brain to complement and interpret information~          from the PET scans. MRI uses a strong magnetic field and radio waves to show structural~          changes in tissues. The subject lies on a table surrounded by a metal cylinder (the~          scanner). During the procedure, which may take from 20 minutes to 2 hours, subjects may~          be asked to perform simple tasks, such as speaking or moving their arms. They can speak~          with a staff member via an intercom at all times during the procedure and can be moved~          out of the machine any time they request.~      Participants may be asked to return for up to two scanning sessions within a year. For these~     scans, only 1 injection of radioactive water will be given.~   "
271699|NCT00024934|"~     This study will examine the safety of BlyS, an experimental drug being developed to treat~     immune deficiency. As of July 17, 2001, 7 persons with common variable immune deficiency~     (CVID) have received BlyS, with no problems reported. This study will test the safety of the~     drug in people with IgA deficiency.~      Patients 18 years of age and older with IgA deficiency who have recurrent or chronic sinus or~     lung infections or chronic diarrhea or malabsorption may be eligible for this study.~     Candidates will be screened with a physical examination, blood and urine tests,~     electrocardiogram (EKG), chest X-ray and a breathing test (spirometry).~      Participants will be divided into five groups of three persons each to receive different~     doses (0.1, 1, 5, 15 or 45 micrograms/kilogram of body weight) of BlyS. The first group will~     receive a single dose at the lowest dose level (0.l mg). Each succeeding group will receive a~     single higher dose following a 2-week observation period of the preceding group. The drug~     will be injected under the skin, with vital signs (temperature, pulse, blood pressure and~     breathing rate) monitored for one hour after dosing. Blood samples will be collected several~     times on the day of dosing (before the dose and at 1.5, 3, 5, 8 and 12 hours after the dose)~     and again at 1,2, 4, 8 and 12 weeks after the dose to measure BlyS levels and evaluate~     safety. Participants receiving one of the three higher doses will have additional blood~     samples collected 36, 48 and 60 hours after the dose. Blood will also be collected from all~     participants 6 and 12 months after dosing to look for any unexpected long-term effects. A~     total of 289 ml (1.2 cups) of blood will be collected.~      Blood will be checked for changes in blood count, kidney and liver function, antibody levels~     and autoimmune problems. Saliva will be collected four times by placing a cotton ball in the~     mouth-once before the dose and three times after the dose-to measure antibody levels.~      Urine samples will also be collected during the study.~   "
271700|NCT00024921|"~     Kidney disease in diabetes (diabetic nephropathy) tends to run in families. It is likely,~     therefore, that there are genes that predict or are associated with either getting or not~     getting diabetic nephropathy. The GoKinD Study will provide clinical information and DNA for~     investigators to look for these genes. Evaluation will be performed and DNA obtained from~     approximately 1100 diabetic persons with kidney disease and 1000 diabetic persons without~     kidney disease. In some cases, samples for DNA will also be obtained from the parents of~     these subjects. Clinical information and DNA will be coded so that individuals cannot be~     identified, but the DNA can be linked to the clinical data from the individual. Multiple~     investigators will be able to use this genetic material to test hypotheses about the genetics~     of kidney disease in diabetes.~   "
271701|NCT00024908|"~     This study will examine the underlying mental processes that determine how people understand~     social behavior, remember information, and think. Language, planning, problem solving,~     reasoning, social behavior, and memory are the critical parts of cognition that make up daily~     life. This study will explore the association between performance on various experimental~     tasks and day-to-day functioning.~      Healthy normal volunteers and patients with certain kinds of brain damage (primarily focal or~     degenerative lesions of the human prefrontal cortex) or psychiatric disorders may be eligible~     for this study. Candidates with central nervous system trauma, disease or dysfunction will be~     screened with a routine neurological examination and history.~      Participants may be asked to complete written tests, sit in front of a computer monitor and~     press a key to indicate a decision about what appears on the screen (for example, whether a~     statement is accurate) and answer questions from a test examiner. A skin conductance response~     (SCR) test may be done along with some of the cognitive tests. SCR uses electrodes (pieces of~     metal attached to wires) placed on the fingers to measure the subject's emotional reaction to~     a test. Participants may also do an evoked response test, in which the subject watches words~     or scenes on a TV screen while his or her responses are recorded from electrodes placed on~     the scalp (similar to an electroencephalogram). The tests will be scheduled for an average of~     one session a week, with each session lasting from 30 minutes to 3 hours. Generally, 15~     sessions will be scheduled over a 1-year period. Special arrangements will be made to~     accommodate participants from out-of-town.~      Participants may have a magnetic resonance imaging (MRI) scan of the brain. This test uses~     radio waves and a strong magnetic field to picture structural and chemical changes in tissue.~     For the procedure, the subject lies on a table in a space enclosed by a metal cylinder (the~     scanner) for about 1 hour.~      In addition, some study subjects will be invited to participate in a training study designed~     to improve their planning or social behavior. Participation requires coming to NIH daily over~     a 1- to 2-month period for 1 to 2 hours each visit.~   "
271702|NCT00024804|"~     This study has four objectives: 1) to provide investigators the opportunity to study bone~     specimens from patients with various skeletal diseases; 2) to treat patients with skeletal~     diseases at the NIH; 3) to expose NIH trainees to certain skeletal diseases; and 4) to gain~     more knowledge about skeletal diseases and stimulate further study of bone biology.~      Anyone with a disease that affects the skeleton may be eligible for this study.~      All evaluations, tests, procedures and treatments given study participants are used in the~     standard care of skeletal diseases. No experimental evaluations or treatments are offered.~     Patient evaluations include a medical history, review of medical records and routine physical~     examination. Based on the findings, other procedures may be recommended, including blood~     tests, urine tests, and imaging tests, such as X-rays, bone densitometry, bone scan, computed~     tomography (CT) and magnetic resonance imaging (MRI).~      Bone specimens from participants will be collected for research use. Specimens will be~     obtained from bone removed during a patient s planned surgical procedure performed for~     medical care, or patients may be requested to have a bone biopsy removal of a small piece of~     bone tissue as part of the patient evaluation procedure.~   "
271703|NCT00024843|"~     To assess the efficacy of a 2-year family-based weight prevention program in a cohort of~     overweight preschool children and overweight parent pairs.~   "
271704|NCT00024830|"~     To evaluate the efficacy of peer-based skills training to enhance weight control and improve~     psychosocial functioning in overweight adolescents.~   "
271705|NCT00024817|"~     To characterize the pattern of change over a two year period in energy expenditure and energy~     intake in two cohorts of American Indian (AI) children.~   "
271706|NCT00024791|"~     This study will examine how the brain controls eye-hand coordination (visuomotor skills) in~     children with spastic diplegia and will determine whether impairment of this skill is related~     to the learning difficulties in school that some of these children experience. Spastic~     diplegia is a form of cerebral palsy that affects the legs more than the hands. The brain~     injury causing the leg problem in this disease may also cause difficulty with eye-hand~     coordination.~      Healthy normal volunteers and children with spastic diplegia between 6 and 12 years of age~     may be eligible for this study. Candidates will be screened with a review of medical and~     school records, psychological testing, neurological and physical examinations, and assessment~     of muscle function in the arms and legs.~      Participants may undergo one or more of the following procedures:~      Neuropsychological testing (1 to 2 hours) - involves sitting at a computer and answering~     questions, such as whether the letters on the screen make up a real word.~      Magnetic resonance imaging (MRI) (45 minutes) - uses a strong magnetic field and radio waves~     to provide images of the brain. The child lies on a table in a narrow cylindrical machine~     while the scans are obtained. Both the child and parent wear earplugs to muffle the loud~     noise the radio waves make while the images are formed.~      Electroencephalography (EEG) and electromyography (EMG) (1 to 2 hours) - EEG uses electrodes~     to record the electrical activity of the brain. The electrodes are in a special cap that is~     worn on the head during the procedure. EMG records electrical activity from muscles.~     Electrodes are placed on the skin over certain muscles. During the test, the child makes~     simple repetitive movements, such as finger tapping. The cap and the electrodes on the skin~     are removed at the end of the test.~   "
271707|NCT00024687|"~     Although Neopharm has terminated its sponsorship of this study, it is continuing under the~     sponsorship of the NCI. Please contact Raffit Hassan, MD at 301-451-8742 for more~     information. Also see the related NCI study Experimental Drug SS1(dsFv)-PE38 to Treat~     Cancer (Study ID number 010011).~      SS1(dsFv)-PE38 is an oncology drug product containing a bacteria toxin, fused to a high~     affinity, disulfide stabilized antibody. The fused protein retains cell killing activity, but~     binds only to cells expressing mesothelin. Tumors characterized by very high surface~     mesothelin expression include mesothelioma; epithelial carcinomas of ovary and peritoneum;~     and squamous cancers of cervix and upper aerodigestive tract, including esophagus, head, and~     neck cancers.~      This is a dose-escalating study to determine the maximum tolerated dose (MTD) of intravenous~     SS1(dsFv)-PE38 administered once every other day for six doses. Dose escalation will proceed~     in cohorts of 3 until dose-limiting toxicity (DLT) is observed.~   "
271708|NCT00024674|"~     Although Neopharm has terminated its sponsorship of this study, it is continuing under the~     sponsorship of the NCI. Please see Experimental Drug SS1(dsFv)-PE38 to Treat Cancer (Study~     ID number 010011).~      SS1(dsFv)-PE38 is an oncology drug product containing a bacteria toxin, fused to a high~     affinity, disulfide stabilized antibody. The fused protein retains cell killing activity, but~     binds only to cells expressing mesothelin. Tumors characterized by very high surface~     mesothelin expression include mesothelioma; epithelial carcinomas of ovary and peritoneum;~     and squamous cancers of cervix and upper aerodigestive tract, including esophagus, head, and~     neck cancers.~      This is a dose-escalating study to determine the maximum tolerated dose (MTD) of intravenous~     SS1(dsFv)-PE38 administered continuously for 10 days every four weeks for a maximum of four~     courses of treatment. Dose escalation will proceed in cohorts of 3 until dose-limiting~     toxicity (DLT) is observed.~   "
271709|NCT00024661|"~     LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein~     produced by human cells, both normal and cancerous, which may help protect tumor cells from~     radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount~     of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to~     raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules~     of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of~     liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that~     decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy.~      Patients with advanced solid tumors will receive IV infusions of LErafAON over at least 60~     minutes, once per week, for 8 weeks. In the absence of progression, patients may continue on~     weekly treatment. Pre-medications will be administered prior to each dose of study~     medication.~      Cohorts of at least three patients will be entered at escalating dose-levels. Each cohort~     will be observed for at least ten days after receiving the first dose of treatment before~     additional patients are treated at a higher dose level. Patients will be followed for one~     month after receiving the last dose of study medication. The study will stop when a maximum~     tolerated dose (MTD) is identified. Dose escalation within a patient will not be allowed.~   "
271710|NCT00024648|"~     LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein~     produced by human cells, both normal and cancerous, which may help protect tumor cells from~     radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount~     of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to~     raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules~     of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of~     liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that~     decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy.~      Patients with advanced malignancies will receive daily IV infusions of LErafAON for 2 weeks~     (total of 10 doses) during clinically indicated palliative radiotherapy. Cohorts of at least~     three patients will be entered at escalating dose-levels. Each cohort will be observed for~     toxicity for at least two weeks after completion of treatment with study medication before~     the next cohort is enrolled. The study will be stopped when a maximum tolerated dose (MTD) is~     identified. Dose escalation within a patient will not be allowed. Safety and supportive care~     requirements will be assessed.~   "
271711|NCT00024622|"~     This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and~     blood flow in normal volunteers, persons with Parkinson s disease (both familial and~     sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for~     NIH approved protocol 89-M-0160, Inpatient Evaluation of Neuropsychiatric Patients, PI:~     Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a~     single scan session, both presynaptic dopaminergic function and regional cerebral blood flow~     (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in~     striatum and other regions is calculated. We compare Ki across subject groups and relate the~     findings to rCBF. Findings are also related to allelic variation in genes of interest, for~     determination of which participants sign separate consent for NIH approved protocol 95-M-0150~     Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their~     Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited~     vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both~     groups, and we compare system-level, circuit-based pathophysiology across PD and~     schizophrenia groups. Each subject is further screened with an MRI to rule out structural~     abnormalities and also to further delineate areas of interest in the PET scans....~   "
271712|NCT00024596|"~     To determine familial and non-familial causes for susceptibility to atherosclerosis and the~     inflammatory response.~   "
271713|NCT00024583|"~     To determine whether maternal undernutrition in pregnancy is associated with differences~     between siblings for cardiovascular risk factors in adulthood.~   "
271714|NCT00024570|"~     IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a~     bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a~     variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic~     benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the~     IL13 receptors was shown to be highly specific for human glioma cells.~      IL13-PE38QQR will be infused in two courses of 96 hours each, eight weeks apart, directly~     into the malignant brain tumors of patients to determine the dose of drug these patients can~     tolerate. After that, the selected dose will be studied to give an estimate of the response~     rate, response duration, time to response, and survival after infusing that dose of~     IL13-PE38QQR into the recurrent malignant glioma.~   "
271715|NCT00024557|"~     IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a~     bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a~     variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic~     benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the~     IL13 receptors was shown to be highly specific for human glioma cells.~      Patients will receive IL13-PE38QQR via a catheter placed directly into the brain tumor. Tumor~     recurrence will be confirmed by biopsy. The next day, patients will start a continuous~     48-hour infusion of IL13-PE38QQR into the tumor. The dose (concentration) will be increased~     in the pre-resection infusion until the endpoint is reached (histologic evidence of tumor~     cytotoxicity or a maximum tolerated dose). Tumor resection will be planned for one week after~     biopsy, plus or minus 1 day. A histologically-effective concentration (HEC) will be~     determined using pathologic observations. At the end of resection, three catheters will be~     placed in brain tissue next to the resection site and assessed within 24 hours using MRI. On~     the second day after surgery, IL13-PE38QQR infusion will begin and will continue for 4 days.~     The lowest pre-resection IL13-PE38QQR concentration will be used as the starting dose for~     post-resection infusions. After an HEC or maximum tolerated dose (MTD) is determined, the~     pre-resection infusion will no longer be administered. Subsequent patients will have tumor~     resection and placement of three peri-tumoral catheters at study entry. IL13-PE38QQR will be~     infused starting on the second day after surgery and continuing for 4 days. Escalation of the~     post-resection IL13-PE38QQR concentration will be continued until the previously-defined HEC~     or MTD is reached, after which duration of the post-resection infusion will be increased in~     one day increments for up to 6 days. If a post-resection MTD is obtained, there will be no~     increase in duration of infusion. In the final stage of the study, catheters will be placed 2~     days after tumor resection, and a 4-day IL13-PE38QQR infusion will begin the day after~     catheter placement. Patients will be observed clinically and radiographically for toxicity~     and duration of tumor control.~   "
271716|NCT00024544|"~     The purpose of the study is to evaluate an investigational medication to treat chronic~     asthma. The research is being conducted at 20 clinical research sites in the US and is open~     to both men and women ages 18 to 70 years. Participants in the study will have a number of~     visits to a research site over an 8-month period. All study-related care and medication is~     provided to qualified participants at no cost. This includes all visits, examinations and~     laboratory work.~   "
271717|NCT00024531|"~     The purpose of this study is to assess the clinical benefit of Lipitor, a~     cholesterol-lowering drug, in the treatment of Alzheimer's disease.~   "
271718|NCT00024518|"~     This study will see if interferon-alpha given early in the disease can stop or slow the~     immune attack on insulin-producing cells. In addition, the study will examine the safety and~     efficacy of interferon-alpha (given by mouth) to protect beta cell function. Patients between~     3 and 25 years of age with Type 1 Diabetes Mellitus less then six weeks may be eligible for~     this study. All study-related tests and medications at the NIH Clinical Center are provided~     at no cost.~   "
271719|NCT00024505|"~     The purpose of this study is to investigate the cardiac, clinical, and genetic aspects of~     arrhythmogenic right ventricular dysplasia (ARVD), a progressive disorder that predominantly~     affects the right side of the heart and causes ventricular arrhythmias.~   "
271911|NCT00002438|"~     To assess the safety and efficacy of itraconazole versus placebo for prevention of~     histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where~     histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing~     other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant~     oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.~   "
271721|NCT00024479|"~     This study will explore the causes of rheumatic diseases and why many of them affect certain~     minority communities more severely. Rheumatic diseases may cause joint pain, stiffness or~     swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of~     the immune system the body s defense against disease. Some rheumatic diseases are painful or~     deforming and some can be life threatening. Information obtained from this study will be used~     to learn about the disparities in rheumatic disease in the minority community and to design~     further, more targeted, research studies to address this issue.~      Patients with known or suspected rheumatic disease 18 years of age or older may be eligible~     for this study. Candidates will undergo a medical history and physical examination to confirm~     the diagnosis of rheumatic disease and determine what is needed for evaluation and treatment.~      Participants will receive standard medical care for rheumatic disease and arthritis. No~     experimental treatments, medications or procedures will be included in this study. Procedures~     may include routine blood tests for blood chemistries, cell counts, and antibodies commonly~     found in patients with rheumatic disease; a urine test for proteins and cells; and X-rays and~     other imaging tests to check for abnormalities in the lungs or other organs. All medical~     information will be kept confidential.~      Patients who are found to be eligible for other current NIH research studies will be offered~     an opportunity to participate in these studies.~   "
271722|NCT00023595|"~     This study will compare medical therapy with coronary bypass surgery and/or surgical~     ventricular reconstruction for patients with congestive heart failure and coronary artery~     disease (CAD).~   "
271723|NCT00023582|"~     The purpose of this study is to provide biomedical and behavioral information that is~     necessary for planning and starting HIV prevention trials in Lima, Peru.~      The occurrence of HIV is high among men who have sex with men (MSM) in Lima, Peru, and~     bacterial sexually transmitted diseases (STDs) and HSV-2 (genital herpes) are very prevalent~     in HIV-positive and -negative MSM there. Methods to reduce both HIV and STDs are urgently~     needed among MSM in Peru. The information gained from this study is very important for future~     HIV prevention and vaccine trials that will take place in Peru.~   "
271724|NCT00023569|"~     This study will determine whether an electric shock to the forearm can improve hand function~     in patients with chronic stroke and, if so, whether the improvement is related to brain~     reorganization. Some studies indicate that electromyography-triggered neuromuscular~     electrical stimulation (EMG-triggered NMES) on the forearm improves wrist motor function in~     patients with chronic stroke. The shock is delivered to the wrist extensor muscle of the~     forearm, causing greater hand movement than the patient can make on his or her own. The study~     will determine if the electric shock is more effective given after the patient initiates the~     hand movement (EMG-triggered NMES) than at times unrelated to patient effort (NMES alone).~      Stroke patients with muscle weakness on one side of the body may be eligible for this study.~     The stroke must have occurred at least 12 months before the patient enters the study.~     Candidates will have a medical history and physical and neurological examinations.~      Participants will be divided randomly into two groups: EMG-triggered NMES, and NMES alone.~     For EMG-triggered NMES, two electrodes from the NMES machine and two EMG electrodes are~     placed on the wrist extensor muscle of the forearm. The patient relaxes the hand, then~     contracts the wrist extensor muscle to produce movement. This movement triggers the NMES to~     deliver enough electrical stimulation to produce maximum wrist extension. For NMES alone,~     only the two NMES electrodes are placed on the forearm. The patient relaxes the hand and~     stimulation is applied at an intensity to produce full wrist extension without any patient~     effort.~      At the first clinic visit, baseline hand function is measured with the following tests:~        -  Wrist extension - wrist extension is measured with a digital instrument called an~          accelerometer~        -  Pinch power - grip strength between thumb and index finger is measured with a digital~          pinch analyzer~        -  Jebsen-Taylor hand function - function is evaluated through activities such as moving a~          can and lifting a pin~        -  H reflex - (Note: I could not find a description of this test or its purpose in the~          consent or the protocol)~      In addition, transcranial magnetic stimulation (TMS) is done to examine brain activity. For~     this test, an insulated wire coil is placed on the patient's scalp. A brief electrical~     current passes through the coil, creating a magnetic pulse that travels through the scalp and~     skull and causes small electrical currents in the outer part of the brain. The stimulation~     may cause muscle, hand or arm twitching, or may affect movement or reflexes. During the~     stimulation, electrical activity of muscles are recorded with a computer or other recording~     device, using electrodes attached to the skin with tape.~      Participants will be instructed in how to use the NMES machine at the first visit. They will~     be required to practice with the machine at home 30 minutes twice a day every day for 4~     weeks, for a total of about 56 sessions. Follow-up evaluations of hand function will be done~     one day after the first NMES or EGM-triggered NMES task, then after 2 weeks and after 4 weeks~     of performing the exercise. These evaluations include the tests described above for baseline~     measurements, plus TMS.~   "
271725|NCT00023504|"~     This study will evaluate immune function in people with a known or suspected immune disorder.~     It will determine participants immune response to vaccines by measuring blood antibody levels~     after vaccination.~      Patients enrolled in a NIH protocol involving immune reconstitution (bone marrow~     transplantation or gene therapy) for a known or suspected primary immune disorder may be~     eligible for this study.~      Participants may be asked to have more than one vaccine, based on their age, use of IVIG,~     past immunization history and underlying immune problem. The possible vaccinations include:~      Rabies vaccine~      Diphtheria and tetanus booster~      23 valent pneumococcal polysaccharide vaccine~      Pneumococcal 7-valent conjugate vaccine~      The diphtheria, tetanus, pneumococcus and rabies vaccines are approved by the Food and Drug~     Administration (FDA) and used routinely to protect against disease.~      Study participants will have a blood sample drawn before vaccination. The number of~     additional samples collected will vary according to the vaccines administered; 1 for rabies;~     1 for tetanus; and 1 to 2 for the pneumococcal vaccines. Each sample will be up to 5~     teaspoonfuls. Participation in the study may last up to a year, depending on the blood~     sampling scheduling~   "
271726|NCT00023465|"~     It has been shown that neutrophils (a specific type of cell) are involved in inflammation in~     the lungs of CF patients. Neutrophil levels in CF patients have been measured by~     bronchoalveolar lavage (BAL), which samples cells in the fluid lining of the lungs. Other~     studies have measured neutrophil levels and inflammation in other parts of the body using PET~     scanning. This study aims to show that PET scanning can be used as a non-invasive marker of~     inflammation in the lungs of patients with CF, which would be a useful tool in treatment.~      The primary goal of this study is to draw a connection between the level of inflammation~     shown in the PET scan and the number of neutrophils obtained from the BAL. This study will~     also look at how the PET images relate to inflammatory molecules in the lungs and to the~     FEV-1 obtained through spirometry.~   "
271727|NCT00023452|"~     Open-label, multi-center, Phase III clinical trial to compare the effectiveness and~     tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid~     (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH)~     to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including~     children and HIV-infected persons, who require treatment of latent TB infection (LTBI).~   "
271728|NCT00023439|"~     This is a pilot study to evaluate the performance of several nucleic acid amplification~     methodologies in the diagnosis and management of active tuberculosis~   "
271729|NCT00023426|"~     Randomized, double-blind study of the tolerability of three different doses of rifapentine~   "
271731|NCT00023400|"~     Primary Objective:~      To define the impact of nelfinavir (given at 1250mg bid as part of a combination~     antiretroviral regimen) on peak levels and area under the curve for rifabutin and the~     rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as~     part of tuberculosis chemotherapy.~      Secondary Objectives:~      To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with~     twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg~     twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.~      To evaluate the correlation between pharmacokinetic parameters of rifabutin and~     25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients~     with HIV-related tuberculosis.~      To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with~     HIV-related tuberculosis.~      To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic~     studies.~   "
271732|NCT00023387|"~     Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl~     rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg.~      Secondary objective: To describe any correlation between pharmacokinetic parameters of three~     different doses of rifapentine plus a standard dose of isoniazid and the occurrence of~     toxicity attributed to anti-tuberculosis treatment.~   "
271733|NCT00023374|"~     This study is a prospective, open-label, nonrandomized trial using a largely-intermittent,~     six-month tuberculosis treatment regimen among patients who will not receive isoniazid due to~     the presence of initial isoniazid resistance or intolerance. Subjects are enrolled after~     resistance or intolerance to isoniazid has been documented, and are treated for a total of~     six months (nine months if baseline chest x-ray shows cavitation and 2-month sputum culture~     is positive) with twice weekly or thrice weekly rifampin, ethambutol, and pyrazinamide.~   "
271734|NCT00023361|"~     Primary objective:~      To determine the rate of confirmed treatment failure and relapse with an intermittent~     rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related~     tuberculosis (TB).~   "
271735|NCT00023348|"~     Primary Objectives:~      1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal~     pharmacokinetic parameters for isoniazid and rifabutin.~      Secondary Objectives:~        1. To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and~          rifabutin.~        2. To evaluate the correlation between pharmacokinetic parameters of isoniazid and~          rifabutin and the occurrence of toxicity attributed to antituberculous therapy.~        3. To evaluate the correlation between pharmacokinetic parameters of isoniazid and~          rifabutin and the efficacy of TB therapy.~        4. To define and correlate phenotypic INH acetylator status with the results of genotypic~          acetylator data obtained in the parent trial.~   "
271736|NCT00023335|"~     Primary Objective: To compare, at the completion of the follow-up phase, the clinical and~     bacteriologic relapse rates associated with the two study regimens.~      Secondary Objectives:~      To compare the clinical and bacteriologic failure rates of the two study regimens at the~     completion of the study phase therapy.~      To compare the clinical and bacteriologic response rates for the two study regimens among~     patients who began study phase therapy with signs and symptoms of tuberculosis or cultures~     positive for M. tuberculosis.~      To compare the toxicity associated with the two study regimens by comparing discontinuation~     rates due to adverse events and occurrence rates of signs and symptoms associated with~     adverse events during study phase therapy.~      To compare mortality rates of the two study regimens. To compare the rates of completion of~     therapy within 22 weeks for the two study regimens.~      To compare the rate of development of drug-resistant tuberculosis in the two study regimens~     among study patients classified as treatment failures or relapses.~      To compare all of the above performance characteristics for the two study regimens in a small~     subset of HIV seropositive patients.~      To compare attitudes and beliefs about participation in this study between patients who~     complete study therapy and those who fail to complete study therapy.~   "
271737|NCT00023556|"~     To examine the genetics of human susceptibility to Chagas' disease, a leading cause of heart~     disease throughout Latin America.~   "
271738|NCT00023543|"~     The purpose of this study is to test the effect of lifestyle intervention on subclinical~     cardiovascular disease measures in women taking hormone replacement therapy (HRT).~   "
271739|NCT00023530|"~     The purpose of this network is to accelerate research in hematopoietic stem cell~     transplantation by comparing novel therapies to existing ones.~   "
271740|NCT00023491|"~     This study will examine whether transplanted stem cells can turn into salivary gland cells in~     stem cell recipients. If so, stem cells might be used to restore salivary gland function in~     patients with Sjogren's syndrome and other causes of dry mouth. People with severe dry mouth~     may develop difficulty swallowing, severe tooth decay, infections of the mouth and pharynx,~     and mouth sores.~      Female patients 18 years of age and older who are enrolled in the National Heart, Lung and~     Blood Institute's protocol 97-H-009 or 97-H-0202 and who have received a stem cell transplant~     from a male donor may be eligible for this study. Five patients with graft-versus host~     disease (GVHD) and five without GVHD will be included. GVHD is a transplantation reaction in~     which the donor's cells mount an immune response against the recipient's tissues. Patients~     with chronic GVHD have mouth ulcerations and dry mouth similar to that of patients with~     Sjogren's syndrome. Five healthy female volunteers will also be enrolled.~      Participants will have a medical and dental history. Then, cells will be collected from the~     inside of the cheek (buccal cell scraping) and from the salivary glands (labial gland biopsy)~     as described below:~      Buccal cell scraping - Cells are collected from the inside of the cheek by wiping for 5~     seconds with a plastic brush.~      Labial glands biopsy - The lower lip will be numbed and a small incision will be made on the~     inside of the lower lip. Six small salivary glands in the lower lip will be removed and the~     incision will be closed with four stitches.~      Cells collected from these procedures will be examined to see if donated stem cells turned~     into salivary gland or cheek cells.~      Patients will return to the clinic 5 to 10 days after the biopsy to have the stitches removed~     and assess healing.~   "
271932|NCT00002416|"~     The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when~     given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.~   "
271933|NCT00002415|"~     The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new~     anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV~     drugs in the past. Genetic response will be studied.~   "
271741|NCT00023322|"~     This study will evaluate the safety and effectiveness of a long-acting form of alpha~     interferon called pegylated interferon in treating hepatitis D virus (HDV) infection. HDV~     only infects people who already have hepatitis B infection. HDV is often severe and~     progressive. Alpha interferon is the standard treatment for HDV, given by injection once a~     day or three times a week for up to 12 months. However, this treatment does not work for~     everyone, and those who respond usually relapse when the drug is stopped. The~     sustained-release form of the drug, pegylated interferon, is given just once a week.~     Pegylated interferon is more effective than standard interferon in hepatitis C patients, with~     patients experiencing longer-term improvement. This study will evaluate the effects of~     pegylated interferon on hepatitis D and hepatitis B. It will determine whether long-term~     therapy with this drug improves inflammation and scarring of the liver, thereby delaying or~     reversing cirrhosis, and whether the improvement can be maintained.~      Patients with chronic hepatitis D over 6 years old may be eligible for this study.~     Participants will have a medical evaluation, including a history and physical examination,~     blood tests, routine urinalysis and 24-hour urine collection. Chest X-ray, electrocardiogram,~     abdominal ultrasound and liver biopsy will be done if these tests have not been done within~     the last year. In addition, depending on their age and individual health status, some~     patients may have exercise stress testing, an eye examination, hearing test, and psychiatric~     consultation. All patients will fill out a health-related quality of life questionnaire.~      Patients will receive pegylated interferon by injection once a week and have blood tests to~     measure the effects of treatment on the liver and on HBV and HDV levels. The medical~     examination and liver biopsy will be repeated at the end of 12 months. Patients who improved~     with treatment may continue therapy long-term. Medical evaluations and liver biopsies will be~     repeated at 3 years and at 5 years.~   "
271742|NCT00023309|"~     This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus~     adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has~     approved lamivudine for the treatment of hepatitis B. However, the drug is not effective in~     all patients, and many of those in whom it initially works develop resistance after 1 to 3~     years. Adefovir is an experimental drug that inhibits replication of the hepatitis B virus~     (HBV). Adefovir used alone may be adequate to provide sustained suppression of the virus and~     improvement in liver disease. However combining two anti-viral agents may be superior to~     using one alone, similar to the strategy employed for the treatment of AIDS. This study will~     test whether the combination of lamivudine and adefovir is better than adefovir alone for the~     treatment of chronic hepatitis B.~      Patients 18 years of age and older, who have been infected with HBV for at least 6 months,~     may be eligible for this study. Candidates may not have received lamivudine treatment in the~     past 6 months or prior treatment with adefovir and must not be taking other anti-viral~     treatments for their hepatitis. They will have a blood test to confirm HBV infection.~      Participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical~     evaluation. One to 2 weeks after the evaluation, patients will be randomized to begin taking~     lamivudine and adefovir, or adefovir alone. Therapy will continue for at least 12 months.~     Follow-up clinic visits will be scheduled weekly for the first month, then every 4 to 8 weeks~     for the rest of the treatment period. Patients will be evaluated at the end of 1 year.~     Patients who have not improved with treatment will stop taking the treatment and will be~     evaluated in the clinic once every 4 weeks for another 6 months. Patients who show an~     improvement in their liver injury may continue taking lamivudine and adefovir or adefovir~     alone for 4 more years, as long as they continue to improve with the medication. Progress~     will be evaluated. If the test results show no continued improvement or are negative for~     hepatitis B antigens, therapy will be stopped.~      Patients who continue treatment for 5 years will be readmitted at year 4 for another medical~     evaluation to assess the effects of treatment at that time. After the 5 years all patients~     will stop therapy at and be followed with regular clinic visits for at least 6 months.~   "
271743|NCT00023296|"~     This study will test whether inhaling nitric oxide (NO) gas mixed with room air can improve~     pulmonary hypertension (high blood pressure in the lungs) in patients with sickle cell~     anemia.~      Patients with sickle cell disease 18 years of age or older may be eligible to participate in~     one or more parts of this three-stage study, as follows:~      Stage 1~      Patients undergo the following tests to determine the cause of their pulmonary hypertension:~     blood tests; echocardiogram (heart ultrasound); asthma test; oxygen breathing study with~     measurement of arterial blood oxygen levels; chest X-ray; lung scans; MRI of the heart;~     6-minute walk test; night-time oxygen measurement while sleeping; and exercise studies.~      Stage 2~      Patients have a detailed MRI evaluation of the heart and are admitted to the NIH Clinical~     Center intensive care unit (ICU) for the following test: A plastic tube is placed in a vein~     in the patient's arm and another tube is placed in a deeper neck or leg vein. A third tube is~     inserted through the vein into the heart and the lung artery to measure blood pressures in~     the heart and lungs directly. Following baseline measurements, three medications (inhaled~     oxygen, infused prostaglandin, and inhaled NO) are delivered for 2 hours each, separated by a~     30-minute washout period. A small blood sample is drawn during the NO administration.~      Patients who cannot be treated with nitric oxide or for whom the treatment does not work may~     receive monthly exchange transfusions for 3 months. For this procedure, 3 to 5 five units of~     the patient's blood is removed and replaced with 3 to 5 units that do not have sickle~     hemoglobin. Some patients who do not respond to NO or exchange transfusions may receive an~     alternative therapy, such as oxygen, prostacyclin, L-arginine, bosentan or sidenafil.~      Stage 3~      Patients remain in the ICU with catheters in place for another 24 hours. During this time~     they breathe NO. Lung pressures are measured every 4 hours and blood is drawn every 8 hours.~     They then stay in the hospital 1 more day for observation. Patients then breathe nitric oxide~     continuously for 2 months using a tank of gas that delivers the NO through tubes placed in~     the nose. They may do this at home on an outpatient basis or may remain in the hospital for~     the 2 months.~      Patients have an echocardiogram and blood tests every week and do a 6-minute walk test every~     2 weeks.~   "
271744|NCT00023283|"~     The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM~     enhanced with additional education about addiction and recovery (Enhanced Medical Management,~     EMM)~   "
271745|NCT00023244|"~     The purpose of this study is to examine the effects of withdrawing steroids on graft~     rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20~     years (prior to their 21st birthday).~      Graft survival has improved in recent years in children with kidney transplants. One bad side~     effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids~     might be safely withdrawn in patients that are receiving other maintenance therapies. If~     steroids are removed, children might catch up in their growth and also might have fewer side~     effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a~     way that does not increase graft rejection.~   "
271746|NCT00023231|"~     The purpose of this study is to see the effect of using drugs other than calcineurin~     inhibitors to improve the rate of kidney transplant failure.~      Kidney transplantation can help children with end-stage kidney disease. However, it has been~     difficult to find treatment for donor graft rejection that does not have a lot of side~     effects. Researchers hope to find treatments (immunosuppressants) with fewer side effects.~     One approach is to avoid using calcineurin inhibitors and to try a new drug known as~     sirolimus instead. Another is to use steroids less often. This study will test whether using~     sirolimus, fewer steroid treatments, MMF, and certain antibodies will improve long-term graft~     survival in children receiving kidney transplants from living donors.~   "
271747|NCT00023218|"~     The purpose of this study is to look at how 2 different anti-HIV drug treatments affect the~     liver.~      The use of anti-HIV drugs like the nucleoside reverse transcriptase inhibitors (NRTIs) may be~     linked to liver problems like fatty changes, scarring, abnormal liver function tests (LFTs),~     and lactic acidemia (an increase in lactic acid in the blood). Increased liver enzymes may~     mean liver damage. The way that the liver changes in people with abnormal LFTs and lactic~     acidemia is not completely understood.~   "
271748|NCT00023205|"~     People with poor literacy may have worse health and less knowledge about how to manage their~     disease than patients at high reading levels. Patients with arthritis usually receive~     information on how to manage their disease that is written at an 11th grade reading level.~     The purpose of this study is to compare the health outcomes of patients with arthritis given~     either standard 11th grade level materials or interactive, in-person arthritis education~     along with materials written at a lower reading level.~   "
271749|NCT00022763|"~     This study will evaluate T-20 in children.~   "
272146|NCT00002201|"~     The purpose of this study is to see if it is safe and effective to give ritonavir plus~     nelfinavir to HIV-infected patients. This study will also see how ritonavir and nelfinavir~     are absorbed by the body and how they affect the level of HIV in the blood.~   "
271752|NCT00021671|"~     The purpose of this study is to see if antibiotic drugs given to treat an infection of the~     uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive~     mother to her baby.~      A link between bacterial disease of the vagina, premature birth, infection of the uterus~     during pregnancy, and the passing of HIV from a mother to her baby has been found. Early~     treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to~     her baby.~      [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed~     that the study antibiotics were not effective in preventing mother-to-child HIV~     transmission.]~   "
271753|NCT00021632|"~     The purpose of this study is to see how treatment of hepatitis C (HCV) patients with~     ribavirin (RBV) affects the anti-HIV drugs stavudine (d4T) or zidovudine (ZDV).~      Studies have shown that RBV may interfere with the action of ZDV and d4T. There is little~     information about the way these drugs interact in the body. This study will examine how the~     drug RBV affects levels of ZDV or d4T in patients who are currently on stable anti-HIV~     therapy.~   "
271754|NCT00021554|"~     The purpose of this study is to show if a dose of T-20 added to an anti-HIV combination~     (chosen specifically for each patient) lowers viral load by at least a certain level after 24~     weeks as compared to an anti-HIV combination (chosen specifically for each patient) alone.~     Another purpose is to show if the patient response to T-20 will be maintained for 48 weeks.~   "
271755|NCT00021489|"~     The purpose of this study is to learn how safe and well-tolerated mycophenolate mofetil (MMF)~     is when given with abacavir (ABC). Another purpose is to see if adding MMF to ABC decreases~     viral load (amount of HIV in the blood) more than ABC alone.~      Many HIV-infected patients who have had heavy exposure to anti-HIV drugs and have experienced~     treatment failure need new treatment combinations. One promising combination is ABC and MMF~     as part of a drug combination. Laboratory studies show that MMF helps ABC destroy HIV in the~     cells and further clinical testing is needed. MMF is not FDA-approved as a treatment for HIV~     infection but has been approved by FDA to prevent rejection of organ transplants. Doses of~     MMF tested in this study will be lower than those used to treat people with organ~     transplants.~   "
271756|NCT00021463|"~     The purpose of this study is to learn whether changing from a type of anti-HIV drug called a~     protease inhibitor (PI) to another type of anti-HIV drug will help to lower the amount of~     fats or sugars in the blood.~      PIs have been effective at keeping HIV viral load (amount of HIV in the blood) down. However,~     some people who take PIs have higher than normal levels of fats and/or sugars in the blood.~     Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the~     abnormal side effects. This study will test 3 different combinations of non-PI drugs to see~     which may improve side effects while keeping viral loads low.~   "
271757|NCT00017992|"~     The purpose of this study is to see if emtricitabine is safe in children infected with HIV~     and to determine the best dose.~   "
271758|NCT00017797|"~     The purpose of this study is to find out if HIV-infected pregnant women who take protease~     inhibitors (PIs) are more likely to have blood sugar problems than those who do not take PIs.~      HIV-infected people generally are treated with a combination of different types of anti-HIV~     drugs, 1 of which is usually a PI. The same holds true for pregnant women, but not much is~     known about the use of these drugs in pregnancy. Blood sugar and liver problems caused by~     anti-HIV drugs in nonpregnant patients are well known but their effects in pregnancy are not.~     Also, certain physical changes brought about by pregnancy may affect the way drugs are~     handled in the body. There remains a need for further study into the use of anti-HIV drugs~     during pregnancy and their effect on the safety of the mother and baby.~   "
271759|NCT00017784|"~     The purpose of this study is to make valganciclovir available, before it is approved for~     marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection)~     and cannot take drugs by injection. This study also will look at the safety of using~     valganciclovir as starting and/or ongoing therapy.~      CMV can cause serious AIDS-related infections in patients with HIV. Drugs that are effective~     against CMV eye infections can be given only by injection; this calls for a thin tube to be~     placed into a vein in the chest so that the patient is not put through getting too many~     needle sticks. An experimental drug, valganciclovir, is similar to 1 of these approved drugs,~     ganciclovir, but is more convenient and easier to use since it can be taken by mouth. Once in~     the body, valganciclovir changes to ganciclovir. Studies have shown that valganciclovir~     tablets can result in the same level of ganciclovir in the blood as ganciclovir injection.~   "
271760|NCT00017771|"~     The purpose of this study is to find out what might increase nerve damage in people with HIV~     who have taken drugs for treatment of HIV disease. Another purpose is to see if nerve exams~     are done correctly before clinical research sites enroll HIV-infected patients.~      Nerve damage is common in patients with HIV infection and can cause serious problems. The~     factors that place patients at risk are not well understood. This study will examine these~     factors in patients with advanced HIV infection and who have been taking anti-HIV drugs.~   "
271761|NCT00017758|"~     The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz [EFV] and~     nelfinavir [NFV]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin,~     and simvastatin) in the blood.~      Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increased lipids~     (fats) in the blood of HIV-infected patients. EFV also is known to increase blood fats.~     HIV-infected patients who take PIs and/or EFV may need to take fat-lowering drugs to correct~     this problem. So it is important to look at possible drug interactions when these drugs are~     taken together. This study will see if taking EFV or NFV, a protease inhibitor, affects the~     blood level of simvastatin, atorvastatin, or pravastatin (all fat-lowering drugs). To obtain~     results more quickly, the study population will be healthy HIV-negative volunteers.~   "
271762|NCT00017719|"~     The best anti-HIV treatment regimen for pregnant women is not known. Protease inhibitors~     (PIs) are often used, but they have side effects that may be harmful for pregnant women. It~     is not known if treatment regimens that do not include PIs are as effective in pregnant women~     as those that include PIs. This trial will compare two anti-HIV treatment plans, one with and~     one without PIs, in women who start HIV treatment during pregnancy. The study will evaluate~     the effects of the anti-HIV drugs on the developing infant and prevention of mother-to-child~     HIV transmission during pregnancy.~   "
271767|NCT00016601|"~     The purpose of this study is to look at the level of depo-medroxyprogesterone acetate (DMPA~     or Depo-Provera) in the blood to see if is affected by certain anti-HIV drugs (nelfinavir~     [NFV], efavirenz [EFV], indinavir [IDV] in combination with ritonavir [RTV], and nevirapine~     [NVP]). This study will also look at the levels of these anti-HIV drugs to see if they are~     affected by DMPA.~      DMPA is a hormonal birth control method that is given as an injection. It is not known if~     taking DMPA together with anti-HIV drugs changes the amount of DMPA and/or the amount of~     anti-HIV drugs in the blood. If higher levels of DMPA occur, side effects may increase. If~     lower levels of anti-HIV drugs occur, the drugs may become less effective against HIV. This~     study will look at the levels of anti-HIV drugs and DMPA in the blood when these medications~     are used together.~   "
271768|NCT00016588|"~     The purpose of this study is to look at the effectiveness of tenofovir disoproxil fumarate~     (TDF) in HIV-infected patients who have never taken anti-HIV drugs.~   "
271769|NCT00016536|"~     The purpose of this study is to find out if there are any bad effects when BufferGel or PRO~     2000/5 Gel are applied to the penis of HIV-infected men.~      Microbicides are products to be used by women for placing into the vagina to prevent passing~     HIV from 1 person to another during sex. Studies have shown 2 investigational microbicides,~     BufferGel and PRO 2000/5 Gel, to be safe and acceptable for women and HIV-negative men. It is~     important to see if the side effects of these products are the same in men as those in women~     and to see if there is any difference in the side effects between circumcised and~     uncircumcised men.~   "
271770|NCT00015704|"~     Interleukin-2 (IL-2) helps the body make infection-fighting white blood cells, including CD4~     and CD8 T cells. One HIV treatment strategy is planned treatment interruption (stopping~     anti-HIV drugs when CD4 count and level of virus in the blood are at certain levels). The~     purpose of this study is to see if IL-2 used with potent anti-HIV drugs allows for longer HIV~     treatment interruptions.~   "
271771|NCT00015691|"~     The purpose of this study is to see whether metformin alone, rosiglitazone alone, or~     metformin and rosiglitazone together will lower insulin levels in the blood and decrease fat~     in the abdomen or other parts of the body.~      Studies have shown that certain anti-HIV medications can cause a number of side effects,~     including high blood sugar (resulting from the body's failure to use insulin), high insulin,~     and excess fat build-up in the abdominal area. These side effects are known to increase the~     risk of heart disease. Metformin and rosiglitazone are 2 drugs that have been shown to lower~     insulin resistance and lessen abdominal fat in patients who are not HIV-infected. This study~     will investigate the use of these drugs in HIV-infected patients.~   "
271772|NCT00015652|"~     This study will test the safety and effectiveness of a new treatment for hepatitis C (HCV) in~     patients who also have HIV.~      The usual treatment for HCV in people who are not HIV-infected is interferon-alfa (IFN) with~     ribavirin (RBV), an approved treatment by the Food and Drug Administration (FDA). This study~     will use a new, longer acting form of IFN called PEG-IFN alfa-2b. PEG-IFN alfa-2b is approved~     by the FDA for use in treating HCV but has not yet been approved for use with RBV. This study~     also will use IL-2, which is a substance that the body naturally produces. People with HIV~     infection usually do not make enough IL-2. IL-2 is being tested in this study to see if it~     will boost the immune system's response to HCV. The FDA has approved IL-2 for the treatment~     of some cancers.~   "
271773|NCT00014937|"~     ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and~     demonstrated the effectiveness of a three-drug regimen. This study will compare the ability~     of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood. The~     study will also evaluate whether patients discontinue the regimens because of drug side~     effects.~   "
271774|NCT00014911|"~     The purpose of this study is to test whether the islet cell transplantation procedures and~     results from a previous study in Edmonton, Canada, can be repeated. The study also is~     designed to learn more about diabetes control using islet cell transplantation.~      This is a Phase I/II study (a study that examines effectiveness and looks for side effects).~     The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood~     sugar levels will not stay normal, despite intensive insulin therapy. A recent study~     conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to~     insulin independence in a majority of the patients treated. This study extends the results~     obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic~     patients with steroid-free immunosuppression.~   "
271775|NCT00014053|"~     The purpose of this study is to compare immune system activity in young people and older~     people who do not have HIV. This information will be compared to that of HIV patients in~     another study.~      Aging affects immune system activity. This study will look at some of the factors involved.~     HIV also affects immune system activity. The results from this study, using healthy~     volunteers, will be compared to those in another study of HIV-infected patients. This may~     provide information on immune system activity in aging and HIV.~   "
271776|NCT00014014|"~     The purpose of this study is to see if the full daily dose of Combivir (zidovudine~     [ZDV]/lamivudine [3TC]) taken once a day is as effective as the usual recommended twice-a-day~     dose.~      Studies have shown that the antiviral activity of ZDV can continue in the body even after~     there does not appear to be any ZDV left in the blood. This occurs because the body breaks~     down the drug into substances that remain active against HIV. The body also breaks down 3TC,~     a drug that is combined with ZDV in the Combivir product, in a similar way. Since antiviral~     activity may continue after Combivir is removed from the body, it may not be necessary to~     take the drug as often as once thought. This study carefully measures levels of the active~     substances in order to find out whether the same amount of antiviral activity occurs with~     less-frequent dosing.~   "
271777|NCT00013897|"~     The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to~     that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).~   "
271805|NCT00007423|"~     The purpose of this study is to see if it is safe to give ALVAC-HIV vCP205, a possible HIV~     vaccine, and to study the immune responses in adult HIV-1 uninfected volunteers.~      Uganda has been severely affected by HIV infection and AIDS and has been selected to~     participate in HIV-vaccine development. The HIV viruses commonly isolated from Uganda are 2~     kinds that are not used in making current vaccines. Current vaccines generate several kinds~     of immune responses. Researchers would like to see if a response to the kind of virus in a~     current vaccine will also protect people from the viruses commonly found in Uganda.~   "
271778|NCT00013871|"~     The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV)~     followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on~     anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of~     children. This study will also look at the protection provided by childhood vaccination~     against measles, pertussis, and hepatitis B virus.~      Pneumococcal infections are the most common AIDS-related infection in HIV-infected children.~     PCV may help reduce the chances of HIV-infected children getting pneumococcal infections.~     This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected~     children receiving HAART. It will look at whether HIV-infected children are protected by~     childhood vaccines received previously and if more doses are safe and improve protection.~   "
271779|NCT00013663|"~     The purpose of this study is to determine if HIV-specific canarypox vaccine and/or~     interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment~     is withdrawn for a certain time period.~   "
271780|NCT00013585|"~     A decrease in mental function often occurs in patients with HIV. Antiretroviral (ARV) drugs~     are used to treat this but are not entirely effective. Some other therapy could play a role.~     The drug selegiline in its pill form is used to treat Parkinson's disease, a serious brain~     disorder. It is believed this drug might protect the brain and repair some damage. This study~     will use this drug in a patch form, which has not been approved by the Food and Drug~     Administration (FDA), to see if it helps with decreased mental function in patients with HIV.~     The purpose of this study is to evaluate the use of selegiline transdermal system (STS) in~     the treatment of decreased mental function in patients with HIV.~   "
271781|NCT00013572|"~     The purpose of this study is to determine the best way to administer the candidate HIV~     vaccine, ALVAC HIV-1 (vCP205).~   "
271782|NCT00013520|"~     The purpose of this study is to compare the effectiveness, safety, and tolerability of 3~     anti-HIV combination treatments that do not use protease inhibitors (PIs).~      The current rule for starting treatment of HIV infection is to combine members from different~     classes of anti-HIV drugs, such as 2 nucleoside reverse transcriptase inhibitors (NRTIs) and~     either a PI or a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, these~     combinations can be complicated and difficult to take, can cause a number of side effects,~     and may become ineffective. Combinations that are simpler, better tolerated, and more~     effective are needed. Because PIs can cause long-term side effects and because HIV can become~     resistant to many of them at the same time, anti-HIV combination treatments that do not use~     PIs are being tested.~   "
271783|NCT00012519|"~     Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has~     not been approved for use in children and the doses for the combination of the two drugs has~     not been studied in children. The purpose of this study is to find a combination of RTV and~     IDV that is safe, well tolerated, and produces drug levels in the blood of children that are~     comparable to effective drug levels in the blood of adults. The effectiveness of the drug~     combination in decreasing the amount of virus in the body will also be studied. The children~     enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.~   "
271784|NCT00012467|"~     The purpose of this study is to examine the antifungal activity of recombinant~     interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.~   "
271785|NCT00011895|"~     The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus~     efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).~   "
271786|NCT00011479|"~     The purpose of this study is to measure blood levels of abacavir in children and adolescents~     over a period of time following a single dose so that a dosage for adolescents can be~     determined.~      Little is known about how abacavir is cleared by the body in adolescents. It has been shown~     that young children require a higher abacavir dose based on weight than adults. Older~     children, or adolescents, may not require as high a dose. This study may provide information~     as to whether the children's dose or the adult dose is better for HIV-infected adolescents.~   "
271787|NCT00011128|"~     The purpose of this study is to test another way to control the amount of HIV in the blood~     (viral load).~      Studies show that stopping all anti-HIV drugs for a time before switching to new anti-HIV~     drugs may improve the response in some individuals who are failing treatment. Other studies~     suggest a benefit if drug-resistance tests are used in selecting a new anti-HIV drug~     treatment. This study tests the effect of stopping anti-HIV drugs for a time before switching~     to anti-HIV drugs selected using drug-resistance test results.~   "
271788|NCT00011089|"~     The purpose of this study is to make tenofovir disoproxil fumarate (DF) available to~     HIV-infected patients who have failed other anti-HIV drug combinations, who have few~     treatment choices available, and whose disease may get worse. This study will allow patients~     to obtain tenofovir DF before it is approved for marketing.~   "
271789|NCT00011050|"~     The purpose of this study is to determine whether laboratory storage of samples affects the~     amount of lactate over 3 years.~      Lactate is a natural substance normally present in the body. Lactate levels can go up for~     many different reasons, including treatment with nucleotide reverse transcriptase inhibitor~     drugs. This study will help researchers know if stored blood samples can be used to test~     lactate levels.~   "
271790|NCT00011037|"~     The purpose of this study is to test how the body's immune system responds to the vaccine~     ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN~     rgp120.~      HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. Many~     worldwide populations cannot afford the antiviral treatments for infected people. HIV~     vaccines offer hope for disease prevention. In this trial, 2 experimental HIV vaccines called~     ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti, Brazil, Peru, and Trinidad~     and Tobago. The study will determine how volunteers' immune systems respond to the vaccines.~     (This protocol has been changed by adding new international sites.)~   "
271806|NCT00007332|"~     The purpose of this study is to see if the vaccines tested are safe when given alone and when~     given together, and how the immune system responds to the vaccines.~      Vaccines are given to people to try to prevent an infection or disease. Early testing in a~     few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to~     use.~   "
272147|NCT00002200|"~     The purpose of this study is to see if it is safe and effective to give 1592U89 to~     HIV-positive adults. This study also examines the influence previous anti-HIV treatment has~     on the effectiveness of 1592U89.~   "
271791|NCT00011011|"~     Long-term control of HIV depends on improvement in an individual's immune system. The purpose~     of this study is to see if either stopping anti-HIV drugs for short periods of time and/or~     adding a vaccine to the anti-HIV drugs being taken will help to better control HIV infection.~     The study will test whether these treatment approaches are safe. The HIV vaccine in this~     study has been tested in people who did not have HIV infection and improved the way their~     immune system worked. This study will evaluate whether these same immune system changes~     happen in people with HIV, and, if such changes do occur, assess whether these changes help~     to improve control of HIV in these patients.~   "
271792|NCT00009555|"~     The purpose of this study is to see if treatment with testosterone will reduce abdominal fat~     in HIV-positive men.~      Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have~     shown that treatment with testosterone may decrease abdominal fat. This study will determine~     if testosterone will reduce abdominal fat in HIV patients.~   "
271793|NCT00009061|"~     The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral~     response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that~     have not taken antiretroviral (ART) drugs.~   "
271794|NCT00008866|"~     The purpose of this study is to find out whether or not the addition of hydroxyurea to~     didanosine (ddI) and other anti-HIV medications will result in better control of HIV~     infection.~      The Food and Drug Administration (FDA) has approved ddI for treating HIV infections.~     Hydroxyurea is approved for treating some cancers and blood disorders. It works against HIV-1~     when combined with ddI. Researchers need to look at how well patients may respond to~     hydroxyurea in combination with ddI and other anti-HIV drugs, and at any side effects.~   "
271795|NCT00008853|"~     The purpose of this study is to test the safety and favorable immune response to an~     anti-streptococcal vaccine (a vaccine that treats a common bacterial infection) in healthy~     non-pregnant women.~      Group B Streptococcus (GBS) continues to be the single most frequent cause of~     life-threatening bacterial infection during the first 2 months of life. Further, GBS~     pregnancy-related morbidity afflicts more than 50,000 women annually in the US. Therefore,~     active immunization of women is an appealing strategy for the prevention of GBS disease in~     pregnant women and their infants during the first 3 months of infant life.~   "
271796|NCT00008840|"~     The purpose of this study is to evaluate the safety and effectiveness of 2 drugs (AmBisome~     versus voriconazole) in treating fungal infections. Immunocompromised patients, especially~     those with persistent fever and neutropenia, are at a high risk of developing deeply~     invasive, life-threatening fungal infections with Candida, Aspergillus, and other~     opportunistic fungal pathogens. The risk of fungal infection increases in direct proportion~     with severity of neutropenia and duration of fever. Antifungal therapy, therefore, is an~     important step in the amelioration of fungal disease.~   "
271797|NCT00008554|"~     The purpose of this study is to compare GW433908 and nelfinavir when each is given with~     abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.~   "
271798|NCT00008528|"~     The purpose of this study is to compare the change in viral load (amount of HIV in the blood)~     of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive~     only selected anti-HIV drugs.~   "
271799|NCT00008489|"~     The purpose of this study is to compare gastrointestinal (stomach and intestines) side~     effects of 2 forms of Videx in HIV-infected patients.~      Videx can be an effective anti-HIV treatment but many patients will not take the medication~     due to its side effects. Videx EC is a capsule form of the drug and may have fewer side~     effects. Also, patients would not have to take as many pills since patients taking Videx EC~     would have to take only 1 capsule per day instead of 2 tablets per day. This study will see~     if patients taking Videx EC have fewer side effects.~   "
271800|NCT00008463|"~     The purpose of this study is to see if treatment with PEG-interferon-alfa-2a (PEG-IFN) plus~     ribavirin is a more effective treatment for hepatitis C virus (HCV) than interferon-alfa-2a~     (IFN) plus ribavirin for patients infected with both HCV and HIV. The study will also compare~     the 2 regimens to see which has fewer side effects.~      HCV infection is common in patients infected with HIV. Patients infected with both HIV and~     HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been~     shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the~     blood longer, which means that patients would not have to take the treatment as often. This~     study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with~     ribavirin.~   "
271801|NCT00007787|"~     The purpose of this study is to see if kidney function can be improved during transplants by~     giving the drug Thymoglobulin with delayed cyclosporine treatment instead of initial~     cyclosporine treatment.~      There have been improvements for patients receiving kidney transplants, yet acute rejection~     is still a problem. This can lead to kidney failure over time. Patients whose graft fails to~     function properly in the first week after transplant do not do as well after 5 years as~     compared to patients without early problems. This study will see if Thymoglobulin, a drug~     that suppresses the immune system, will improve early graft function.~   "
271802|NCT00007488|"~     The purpose of this study is to gain information on how the type and amount of HIV present in~     certain places in the body and in the blood are affected when potent (powerful) anti-HIV~     drugs are given.~      Researchers know that the type and amount of HIV may differ in certain places in the body~     (called compartments) but are not sure how anti-HIV treatment affects these differences. This~     study gathers information to help understand how the virus grows and changes between blood~     and nonblood compartments in patients receiving anti-HIV treatment.~   "
271803|NCT00007449|"~     The purpose of this study is to determine the safety and tolerability of the study drug DPC~     083 combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected~     patients who are failing their nonnucleoside reverse transcriptase inhibitor (NNRTI)~     treatment.~      In some studies DPC 083 (an NNRTI) has been found to lower the amount of HIV in the blood~     (viral load), where drug-resistant types of HIV were not lowered by other NNRTIs. This study~     will attempt to determine how safe DPC 083 is when it is taken in combination with 2 NRTIs.~   "
271804|NCT00007436|"~     The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate~     (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in~     other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at~     different doses, and may benefit from having tenofovir DF treatment.~   "
271808|NCT00007202|"~     The purpose of this study is to determine the safety and effectiveness of stavudine (d4T),~     didanosine (ddI), and BMS-232632 when given early in the course of HIV infection.~      Acute HIV infection may develop in patients that are exposed to the HIV virus. Following~     infection, the viral load (level of HIV in the blood) rises rapidly over the next few days to~     weeks. It is not known which is the best treatment in patients with very early HIV infection.~     Researchers believe these patients may respond well to strong early treatment. A combination~     consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease~     inhibitor, BMS-232632, will be tested.~   "
271809|NCT00006643|"~     The purpose of this study is to find if the Single Photon Emission Computed Tomography~     (SPECT) scan is as effective as a liver biopsy (using a special needle to remove tissue from~     the liver) in examining liver damage in patients with HIV and hepatitis C virus (HCV).~      A standard way to examine the liver for disease has been to perform a liver biopsy. The SPECT~     scan, which takes a picture of the liver, has been found to be effective in determining liver~     damage but studies need to be done in patients with hepatitis. This study will compare the~     effectiveness of the liver biopsy and SPECT scan in determining liver disease in patients~     with HIV and HCV. The SPECT scan might be a good replacement for the liver biopsy if it is~     found to be as good as or better than liver biopsies.~   "
271810|NCT00006630|"~     The purpose of this study is to follow responses to treatment with vaccinia immune globulin~     (VIG) for safety and clinical benefit [during HIV vaccine research].~      VIG is purified from human blood and used to treat serious infections of the vaccinia~     (smallpox vaccine) virus or similar viruses. It is the only treatment available for those~     viruses. The only available supply of VIG has developed a discoloration over time and~     therefore is considered an investigational new drug by the FDA. This study will allow it to~     be used for intramuscular injection in a controlled setting for people who may need it~     [during HIV vaccine research].~   "
271811|NCT00006617|"~     The purpose of this study is to see if the multidrug combination of zidovudine (ZDV),~     lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and~     effective treatment for HIV-infected patients and if there is a reduction of active HIV in~     blood and other tissues.~      HIV infection is a life-changing illness and new HIV treatments must be tested. This study~     will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues~     and if it is safe and well tolerated. Doctors also want to know if the multidrug combination~     is able to decrease viral activity over a long time period.~   "
271812|NCT00006604|"~     The purpose of this study was to find a safe and tolerable dose of the protease inhibitor~     (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken~     with other anti-HIV drugs in HIV infected infants, children, and adolescents.~      Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to~     make, in part because these patients often do not take the drugs as prescribed. ATV may be a~     better option because it is available in the form of powder which children and adolescents~     may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV~     may also increase the chances of virologic response of highly active antiretroviral treatment~     (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with~     or without low-dose RTV boost in infants, children, and adolescents. For this study,~     participants were enrolled in the United States and South Africa.~   "
271813|NCT00006591|"~     The purpose of this study is to determine if treatment with an anti-HIV drug containing~     ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who~     have failed an anti-HIV drug treatment containing nelfinavir.~   "
271814|NCT00006578|"~     The purpose of this study is to see if the amount of stem cells (cells that can develop into~     many kinds of cells) in the blood before anti-HIV drugs are taken can predict if the immune~     system will become stronger after anti-HIV drugs are given and if anti-HIV drugs can restore~     stem cells.~      HIV infection has been shown to cause stem cells not to function well. Granulocyte~     colony-stimulating factor (G-CSF), which causes stem cells to go from the bone marrow~     (tissues in the bones where blood cells are formed) into the bloodstream, could possibly help~     boost immunity after anti-HIV treatment. This study examines the effects of G-CSF in helping~     the immune system become stronger after beginning anti-HIV treatment.~   "
271815|NCT00006509|"~     The purpose of this study is to see if 2 study vaccines, ALVAC-HIV (vCP1452) and gp160~     MN/LAI-2, are safe and effective in boosting the body's attacks on HIV in HIV-positive~     patients.~      HIV-infected patients who have been treated with anti-HIV drugs for a long time may have~     weakened immune responses. One way to strengthen these responses may be to have a safe and~     effective vaccine, which will boost immune responses that are specific to HIV.~   "
271816|NCT00006495|"~     The purpose of this study is to see how the vaccines Remune (HIV-1 immunogen) and vCP1452~     affect immune responses in patients who also are taking anti-HIV medications. This study also~     will see if these vaccines are safe to use either alone or in combination.~      Treatment with anti-HIV drugs does not always keep HIV viral load low and under control. This~     study will look at the effect of the HIV vaccine, vCP1452, on the immune response and how it~     works in combination with Remune. Information about immune responses and the safety of these~     vaccines in HIV-positive patients will be gathered.~   "
271817|NCT00006490|"~     The purpose of this study is to compare 2 different types of tests of the HIV virus to see~     which specific anti-HIV drugs would work the best.~      Drug resistance is a major reason for therapy failure in HIV patients. Two types of tests can~     detect resistance to drugs: 1) genotyping (sequencing), which looks at the DNA sequence of a~     virus to see whether it has developed any genetic resistance; 2) phenotyping, which looks at~     the ability of different drugs to suppress virus growth in the laboratory. Genotyping and~     phenotyping can help doctors give patients the most effective drug therapy.~   "
271842|NCT00006154|"~     The purpose of this study is to look at the effectiveness of combination anti-HIV drug~     therapy (with protease inhibitors [PIs] or without) in patients with early HIV infections.~     This study also looks at whether a drug called interleukin-2 (IL-2) can boost the immune~     system of these patients.~      Doctors are not sure which anti-HIV drug combination is best to use in patients who have~     early HIV infection and have never received anti-HIV treatment. PIs are anti-HIV drugs that~     decrease viral load (level of HIV in the blood). However, PIs can cause serious side effects~     in some patients. Doctors would like to know if a drug combination that does not contain a PI~     is just as good as one that contains PIs.~   "
271818|NCT00006444|"~     The purpose of this study is to see how often human papillomavirus (HPV) occurs in~     HIV-infected women who have not taken anti-HIV drugs and to learn whether taking anti-HIV~     drugs will affect HPV in women.~      HIV infection increases the risk of getting HPV infection. Findings suggest that HIV~     infection as well as a weakened immune system may increase the chances of getting HPV.~     Aggressive anti-HIV medication has been shown to strengthen the immune system. Researchers~     want to learn whether anti-HIV drugs affect the HPV virus or decrease the chances of getting~     HPV. This study is important because it may provide important information to help manage a~     woman's health and to determine a woman's risk for developing problems with the cervix (outer~     end of the uterus).~   "
271819|NCT00006443|"~     The purpose of this study is to compare changes in HIV levels and certain immune cells among~     patients at different stages of HIV infection. This study will also see how a combination of~     stavudine (d4T), lamivudine (3TC), indinavir (IDV), and nelfinavir (NFV) affects these~     levels.~      Current findings in anti-HIV drug treatment have led to a greater understanding of the~     background of HIV. To find the best anti-HIV treatment to eliminate all HIV viruses, cells~     and tissues infected with the HIV virus are examined after combination anti-HIV treatment,~     when the level of HIV infection is low. The ERADICATE study will examine the idea that HIV~     viruses can be eliminated at any stage of infection over time.~   "
271820|NCT00006442|"~     The purpose of this study is to examine the HIV virus in the blood and lymphoid tissues of~     patients taking anti-HIV medications.~      HIV infection is closely linked to the growth of the HIV virus in the body. Much of this~     information was obtained from studying how the HIV virus grows in circulating blood. Recent~     studies have shown that the lymphoid tissue (part of the immune system) is a major site where~     HIV is found in the body and is also where much of the HIV virus growth occurs. This study~     will examine not only blood but also lymphoid tissue to gain a better understanding of the~     disease and how to treat it.~   "
271821|NCT00006441|"~     The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV~     drugs affects the course of HIV disease in patients with primary HIV infection (the time~     period that immediately follows infection with HIV).~      After primary HIV infection, the actual infection is spread through an increasing amount of~     HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it~     is possible to reduce the amount of HIV in the body to almost undetectable levels. This study~     will find out if starting anti-HIV drugs during primary infection will interrupt or reduce~     the spread of HIV in patients' bodies.~   "
271822|NCT00006440|"~     The purpose of this study is to find out if it is possible to conduct a group counseling~     program for women at risk for HIV infection.~      Women have been the fastest-growing group with new AIDS diagnoses. The need for ways to~     reduce HIV infection in women is urgent. It is important to reduce the risk of HIV infection~     through sexual contact, but it is also important to address drug use. Group counseling may be~     an effective method.~   "
271823|NCT00006415|"~     The purpose of this study is to find out if anti-HIV drugs, taken by patients who are newly~     infected with HIV, can make the level of HIV in the body too low to detect.~      Studying patients who recently have been infected with HIV may help researchers understand~     how HIV infection works and how anti-HIV drugs may help these patients. Approved anti-HIV~     drugs can reduce the amount of HIV, but more research needs to be done in newly infected~     patients. This study will look at recently HIV-infected patients to study the progression of~     HIV disease and to see whether anti-HIV drugs can reduce the level of HIV.~   "
271824|NCT00006412|"~     The purpose of this study is to compare the safety and effectiveness of fenofibrate and~     pravastatin in treating HIV-positive patients who have abnormal levels of fat (lipids) in the~     blood.~      Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing~     problem. The drugs used in this study are known to reduce certain lipids, but little is known~     about their safety and effectiveness. This study will see if one of the drugs is safer and~     more effective than the other, or if combining the drugs is the safest and most effective way~     to lower lipids. This study has been changed. On June 26, 2001, this study was reviewed by~     the Data and Safety Monitoring Board (DSMB). The DSMB is an independent board monitoring the~     progress of the study. The review showed that neither pravastatin nor fenofibrate alone were~     effective in reaching all the cholesterol and triglyceride goals. There were no safety~     concerns. It is not known if the combination of fenofibrate and pravastatin is effective and~     safe. Therefore, it is important to continue this study.~   "
271825|NCT00006397|"~     The purpose of this study is to see how safe and effective it is to give multi-drug treatment~     with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine~     (d4T) and if there are differences in responses between men and women.~   "
271826|NCT00006396|"~     The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers~     during labor and delivery and to their babies during the first week of life, can reduce the~     rate of mothers passing HIV to their babies.~      About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and~     delivery. There is an urgent need to find a simpler way to prevent mother-to-infant~     transmission during labor and delivery. The proposed NVP schedule is simpler and possibly~     could be used in Uganda.~   "
271827|NCT00006339|"~     The purpose of this study is to compare the safety and effectiveness of an anti-HIV drug~     combination with and without hydroxyurea in patients with early HIV infection.~      Certain combinations of anti-HIV drugs have been effective in lowering levels of HIV in the~     blood and keeping them down. However, these treatments are not effective in some patients.~     This study will see if using a combination containing more drugs will help in patients with~     early HIV infection.~   "
271828|NCT00006327|"~     The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect~     intravenous drug users from becoming infected with HIV.~   "
271829|NCT00006326|"~     The purpose of this study is to see if 3 anti-HIV drug combinations are safe and effective in~     patients who have failed previous anti-HIV treatments using nelfinavir (NFV).~   "
271908|NCT00002441|"~     The purpose of this study is to see if an HIV vaccine, AIDSVAX B/B, can protect adults who~     are at risk from becoming infected with HIV. Patients who become infected despite~     immunization will be studied to see if receiving the vaccine before becoming infected will~     help keep HIV levels (viral load) low.~   "
271830|NCT00006325|"~     The purpose of this study is to see if PEG-Intron is safe and tolerated when given to~     children, to see how much gets into the blood and how long it stays in the blood, and to see~     how well it works to reduce viral load (level of HIV in the blood).~      PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It~     decreases the ability of HIV to infect the T cells (a special type of cell that helps fight~     infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat~     hepatitis C in adults, but in this study, it is being used as an investigational agent for~     the treatment of HIV/AIDS. It has not been tested in children before and experience with~     PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of~     PEG-Intron for treating hepatitic C in adults.)~   "
271831|NCT00006324|"~     The purpose of this study is to find out whether hormonal birth control increases, decreases,~     or does not change the risk of women becoming infected with HIV.~      Sexual intercourse between men and women is the main way HIV is transmitted. About 90 percent~     of HIV infections in women are caused by sexual intercourse. Also, hormonal birth controls~     are widely used. This study hopes to find out whether hormonal birth control changes the risk~     of women becoming infected with HIV.~   "
271832|NCT00006316|"~     The purpose of this study is to determine whether stopping preventive histoplasmosis~     medications in patients who are currently receiving effective anti-HIV drugs will place them~     at risk for getting histoplasmosis again.~      Histoplasmosis is a serious opportunistic (AIDS-related) infection that responds well to~     antifungal medications. Before anti-HIV drugs, patients with histoplasmosis required lifelong~     antifungal therapy. Patients who take anti-HIV drugs for a long time may see an improvement~     in their immune system functions. Improved immune function may eliminate the need for~     long-term preventive treatment with antifungal agents. Doctors want to see if the improved~     immune functions allow preventive treatment for histoplasmosis to be stopped. (This study has~     been changed to include histoplasmosis treatment with drugs other than itraconazole.)~   "
271833|NCT00006304|"~     As new drugs and vaccines are developed to prevent HIV disease progression and prolong~     survival of HIV infected patients, the short-term safety and effectiveness of these~     treatments are evaluated in research studies. However, the long-term effects, whether they~     are benefits or side effects, need to be studied as well. These long-term effects may have a~     greater impact on infants and children who are still growing and developing. The purpose of~     this study is to follow HIV-exposed and HIV infected infants, children, and adolescents who~     are seen at Pediatric AIDS Clinical Trials Group (PACTG) study sites. These patients will be~     observed for long-term benefits or any late harmful effects of medications or vaccines.~   "
271834|NCT00006298|"~     The main goal of this study is to find out how the immune system responds to a specific type~     of HIV infection, known as C HIV-1, in order to develop a vaccine against this type of~     infection. The study involves Southern African populations.~      The HIV-1 virus changes rapidly and many different subtypes have been found. In South Africa,~     limited data have suggested Subtype C HIV-1 is the most common. This study strives to verify~     the most common subtype and also look at genetic differences and immune responses among newly~     infected individuals. Results will aid in the development of vaccines specific for certain~     geographical areas.~   "
271835|NCT00006291|"~     The purpose of this study is to see if adding an HIV vaccine (ALVAC-HIV vCP1452), IL-2~     (interleukin-2, a protein found in the blood that helps boost the immune system), or both to~     anti-HIV-drug therapy is safe, tolerable, and effective in controlling viral load (level of~     HIV in the body). (This study has been changed to clarify drug name.) Anti-HIV drugs can help~     reduce a patient's viral load. However, HIV can still remain in CD4 cells (cells of the~     immune system that help fight infection). Combining an HIV vaccine, IL-2, or both with~     anti-HIV drugs may help reduce the number of HIV-infected cells.~   "
271836|NCT00006290|"~     The purpose of this study is to learn how changes in body build affect the lives of people~     taking anti-HIV medications. By learning this, a set of questions can be created to help~     understand how changes in body build and image affect people living with HIV infection.~      A set of questions used to measure body image might be useful in future HIV studies. It may~     help doctors understand patient concerns about their body image and why some patients stop~     taking their anti-HIV medications.~   "
271837|NCT00006279|"~     The purpose of this study is to see if it is safe to give nevirapine (NVP) to breast-feeding~     babies from birth to the age of 6 months and to determine what dose of NVP should be given.~      Breast-feeding has been shown to be very important for the physical and mental health of~     infants. This is especially true during the first 6 months of life. However, an HIV-positive~     mother can pass the virus on to her baby by breast-feeding. Because of this risk,~     HIV-positive mothers are encouraged to formula-feed, not breast-feed, their babies. In~     developing countries, however, some women cannot afford to formula-feed. If they do~     formula-feed, these women risk exposing their HIV status. These women have great need for~     methods that can lower the chance that they will pass HIV on to their babies. This study will~     test NVP as a way of doing this.~   "
271838|NCT00006211|"~     The purpose of this study is to see if the addition of capravirine to VIRACEPT (nelfinavir~     mesylate) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is an effective~     combination drug therapy for HIV patients who have failed a nonnucleoside reverse~     transcriptase inhibitor (NNRTI) therapy.~   "
271839|NCT00006209|"~     The purpose of this study is to see if it is safe to give tucaresol to HIV-infected patients~     who are taking combination anti-HIV therapy (HAART). This study also examines the effect~     tucaresol has on viral load (level of HIV in the body) when tucaresol is used with HAART.~   "
271840|NCT00006208|"~     The purpose of this study is to compare the safety and effectiveness of emtricitabine and~     stavudine when given with didanosine plus efavirenz to HIV-infected patients.~   "
271841|NCT00006207|"~     The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes~     irritation when used daily.~      Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women~     who are not sexually active. However, it was not determined what side effects to skin in the~     vaginal area there might be in sexually active women.~   "
271909|NCT00002440|"~     The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain~     protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV~     drugs. This study also examines how the body processes these drugs when they are given~     together.~   "
271843|NCT00006153|"~     The purpose of this study is to see if giving a vaccine (Remune) is effective in HIV-positive~     patients who are also taking anti-HIV therapy.~      Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of~     the HIV virus in the body. A vaccine called Remune works to stop the virus infection by~     boosting the body's immune cell defense against the HIV virus before the virus enters~     cells. It also blocks the virus from entering the cells. This study will see whether Remune~     will improve the immune cell natural defense in patients who are also taking anti-HIV drugs.~   "
271844|NCT00006152|"~     The purpose of this study is to see if adding 1 or 2 drugs to the anti-HIV therapy of~     patients whose HIV levels increased while taking their anti-HIV drugs can lower viral load~     (amount of HIV in the blood) and keep it low up to Week 24. (This study has been changed.~     Previously, only patients whose levels increased on their first round of anti-HIV drugs were~     being studied.) Anti-HIV drug treatments that contain a combination of 3 or more drugs can~     lower HIV levels, raise CD4 cell counts, and improve survival. Unfortunately, many patients~     fail their anti-HIV drug treatment when their HIV levels go above 500 copies/ml. Usually~     the next step is to switch the patient to different anti-HIV drugs. Doctors would like to see~     whether adding 1 or 2 different drugs to the failed treatment also can lower HIV levels.~     Adding 1 or 2 drugs might be better than switching all of the drugs since patients who take~     many different drugs can develop drug-resistant HIV. (This study has been changed.~     Previously, only patients taking protease inhibitors (PI) whose levels increased on their~     first round of anti-HIV drugs were being studied.)~   "
271845|NCT00006146|"~     It appears likely that there will be a delay and possibly a reduction in the amount of~     influenza vaccine available for the 2000-2001 influenza season. One possible way of~     increasing the availability of influenza vaccine for this year is to use a half-dose in~     healthy adults. The objective of this study is to determine if the immune system responds to~     a half-dose the same way it responds to a whole dose. This study will use the currently~     approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old.~      If the immune response to the half-dose is not significantly different than the immune~     response generated to the whole dose, this could be a strategy to extend the amount of~     vaccine that could be available in this age group.~   "
271846|NCT00006145|"~     Cytomegalovirus (CMV) infection is a common opportunistic infection (OI) in HIV patients. The~     purpose of this study is to find out whether valganciclovir, an antiviral approved by the FDA~     for the treatment of CMV in the eye, is safe and effective in preventing CMV organ damage in~     people with HIV.~   "
271847|NCT00006144|"~     The purpose of this study is to better understand the relationship between age and HIV~     disease progression.~      This study will explore the possible relationship between age and HIV disease progression.~     Older age is an important risk factor for faster disease development, but older people may~     respond better to combination drug therapy. This relationship needs to be understood better.~   "
271848|NCT00006143|"~     The purpose of this study is to determine the effectiveness of recombinant human growth~     hormone (r-hGH) on growth in HIV-infected children.~      Studies have shown that HIV-infected children do not grow at a normal rate and are shorter~     than HIV-uninfected children who are the same age. Growth hormone has been used for many~     years to treat children with growth hormone deficiency and has been safe and effective in~     helping them to grow normally. The growth hormone to be used in this study, r-hGH, is an~     investigational hormone (not yet approved by the Food and Drug Administration [FDA]) made in~     the laboratory. It has helped HIV-positive adults gain weight and improve their physical~     performance. This study has been changed to include a needle-free device for drug delivery~     which will improve patient comfort and acceptability. Patients will no longer receive growth~     hormone through traditional needles but through a needle-free device.~   "
271849|NCT00006075|"~     The purpose of this study is to find the best strength of chlorhexidine (a solution that~     kills germs), for washing the mother's vagina during labor and the newborn baby, that may~     reduce the chance of HIV being passed from an HIV-positive mother to the baby.~      When used as a wash on the vagina during labor, and on a newborn shortly after birth, a~     higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from~     mother to baby. Laboratory tests suggest that a higher dose of chlorhexidine will be more~     effective in killing HIV.~   "
271850|NCT00006066|"~     The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2)~     given with anti-HIV therapy in children with HIV infection. This study will also determine~     the best dose of IL-2 to give children.~      IL-2 is an important substance produced by the body's white blood cells that helps the body~     fight infection. People with HIV infection do not produce enough IL-2. It is hoped that IL-2~     treatment will help boost the immune system in people with HIV infection. It has not been~     studied very much in children and doctors need to know what doses are safe to give.~   "
271851|NCT00006064|"~     The purpose of this study is to see how beginning or changing anti-HIV medications affects~     the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle~     distribution) of HIV-infected children. This study also looks at how changes in body~     composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts,~     height, and weight in HIV-infected children. This study also compares changes in body~     composition to levels of cytokines (proteins in the body that affect some immune cells) in~     HIV-infected children who are beginning or changing anti-HIV therapy.~      Though studies have been done on adults, little is known about the effects of HIV infection~     and anti-HIV drugs on body composition in children. One theory is that changes in body~     composition can predict the failure of anti-HIV treatment. If this is true, body composition~     measurements can be as useful as CD4+ cell counts in determining drug effectiveness.~   "
271852|NCT00005931|"~     The purpose of this study is to test the effectiveness of SU5416 in patients with~     AIDS-related Kaposi's sarcoma (KS).~   "
271853|NCT00005921|"~     The purpose of this study is to see if it is safe to give L-743,872 to men with candidal~     esophagitis, an AIDS-related yeast infection in the esophagus.~   "
271854|NCT00005920|"~     The purpose of this study is to see if it is safe and effective to give L-743,872 to patients~     with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with~     fluconazole treatment.~   "
271855|NCT00005918|"~     The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine~     (d4T). One form is taken once a day (extended release) and the other form is taken twice a~     day (immediate release).~   "
271856|NCT00005915|"~     The purpose of this study is to compare 2 treatment plans to try to increase the effects of~     anti-HIV drugs in patients who are resistant to the drug effects.~      Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be~     slowed or stopped by taking anti-HIV drugs. This does not always happen. Sometimes anti-HIV~     drugs work at first but then stop working. When most of the usual anti-HIV drugs no longer~     seem to work, the virus is called multidrug-resistant (MDR). This study will compare 2~     treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus.~   "
271857|NCT00005779|"~     The purpose of this study is to see if it is safe to give C4-V3, a possible HIV vaccine,~     alone or in conjunction with 4 different doses of interleukin-12 (IL-12), to HIV-infected~     patients who are taking anti-HIV drugs that have lowered the amount of HIV in patients'~     blood. (This study has been changed so that vaccine is administered alone or with 4 different~     doses of IL-12.) Immune cells known as cytotoxic T lymphocytes (CTLs) help destroy~     HIV-infected cells. However, in most patients, CTLs decrease over time. This allows HIV~     levels to rise and AIDS symptoms to develop. The C4-V3 vaccine contains small pieces of HIV~     protein that can boost CTL levels, allowing the body's immune system to fight HIV. Giving~     IL-12, a normal part of the immune system, with C4-V3 may make the vaccine more effective.~   "
271858|NCT00005764|"~     The purpose of this study is to see if the findings of increased lactic acid and abnormal fat~     distribution get better when d4T is replaced with abacavir, abacavir plus lamivudine, or~     Combivir (a pill containing lamivudine plus zidovudine) in HIV-positive patients taking~     anti-HIV therapy including stavudine (d4T).~   "
271859|NCT00005762|"~     The purpose of this study is to measure the blood levels of amprenavir (APV) alone, APV~     combined with efavirenz (EFV), and APV/EFV combined with a third drug (nelfinavir [NFV],~     indinavir [IDV], ritonavir soft gel capsules [RTV sgc], or saquinavir soft gel capsules [SQV~     sgc]).~      Anti-HIV therapy with 3 or 4 drugs is currently the recommended approach for treating HIV~     infections. Doctors need to know the best dosages of certain drugs when they are given in~     combination. This study will measure the blood levels of APV alone, APV combined with EFV,~     and APV/EFV plus a second PI in healthy volunteers. It will study the safety and tolerance of~     these drugs.~   "
271860|NCT00005758|"~     The purpose of this study is to look at the effects of the HIV vaccine Remune on viral load~     (level of HIV in the blood) and on the way the immune system responds to HIV. This study will~     also try to see if the effects of the vaccine are different in patients entering the study~     with a viral load below 50 copies/ml compared to those who have a viral load from 50 to 500~     copies/ml. (This study is currently being redesigned and the purpose may be revised.)~     Treatment with anti-HIV drugs does not always keep HIV viral load undetectable (so low that~     it cannot be measured). This study originally added an HIV vaccine called Remune to treat~     patients. Remune was thought to reduce viral load and improve immune responses. However, new~     information suggests that Remune may not be as effective as was first believed. The study has~     been changed to follow people already in the study and to let people enroll only if they~     participate in the substudy. The substudy will look at the effect of another HIV vaccine,~     vCP1452, on the immune response and how it works in combination with Remune. Information~     about the safety of these vaccines in HIV-positive patients will be gathered.~   "
271861|NCT00005668|"~     To compare the safety and effectiveness of itraconazole oral solution to placebo in the~     treatment of a pulmonary aspergilloma.~      Aspergilloma is a fungal ball in the lungs caused by Aspergillus. The infection can spread~     from the lungs through the blood to other organs. Aspergilloma can be life-threatening;~     therefore, an effective treatment is needed.~   "
271862|NCT00005663|"~     The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective~     treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and~     external genitals) in HIV-infected patients.~   "
271863|NCT00005572|"~     The purpose of this study is to understand how changes in the immune system of HIV-infected~     patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP),~     cytomegalovirus (CMV) retinitis, or CMV organ disease. The purpose also is to understand how~     anti-HIV medicines may improve the immune system in these patients. (This purpose reflects a~     change in the AIDS-related [opportunistic] infections studied.) Presently, HIV-infected~     patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of~     the disease. This study is trying to see if a special lab test can help identify which~     patients can stop this preventive therapy without having another episode of PCP or CMV organ~     disease. (This rationale reflects a change in the AIDS-related infections studied.)~   "
271864|NCT00005120|"~     The purpose of this study is to see if it is safe and effective to give calanolide A to~     HIV-infected adults who have not used anti-HIV drugs in the past.~   "
271865|NCT00005118|"~     The purpose of this study is to see if it is safe and effective to give indinavir plus~     ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.~   "
271866|NCT00005113|"~     The purpose of this study is to compare treatment with the new drug sirolimus (SRL) versus~     the standard treatment with cyclosporine (CsA) or tacrolimus in children who have received~     kidney transplants. SRL is a new medication that may prevent the body's immune system from~     rejecting organ transplants.~      After receiving a kidney transplant, the body recognizes the donated kidney as a foreign~     invader and triggers the immune system to attack the kidney. This can lead to rejection of~     the new kidney and a failed transplant. To help reduce the risk of kidney rejection,~     transplant patients are given immunosuppressant drugs, which reduce the body's normal immune~     response and allow the transplanted organ to function. CsA or tacrolimus are two drugs that~     are often given to transplant patients. However, these are powerful drugs, and it can cause~     serious side effects and put a patient at increased risk for infections. SRL is a new drug~     that has been shown to reduce a transplant patient's chance of rejecting a new kidney,~     without serious side effects. This study is necessary to test the safety and effectiveness of~     SRL in children.~   "
271867|NCT00005106|"~     The purpose of this study is to look at the effects of different anti-HIV drug combinations~     on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.~   "
271910|NCT00002439|"~     The purpose of this study is to see if ALRT1057 gel is safe and effective in treating~     Kaposi's sarcoma (KS) when applied to skin .~   "
272188|NCT00002159|"~     To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive~     or negative persons with blastomycosis or histoplasmosis.~   "
271868|NCT00005020|"~     The purpose of this study is to monitor patients who have recently been infected with HIV in~     order to learn how their immune systems respond to HIV infection and to study how the virus~     multiplies in their bodies.~      Patients who have been infected with HIV recently are considered to have acute, or early, HIV~     infection. During this period, viral load (level of HIV in the body) rises sharply to a high~     level at first but then decreases significantly on its own. Doctors are not sure why this~     decrease in viral load happens and how the body is able to accomplish this. In this study,~     patients with acute HIV infection will be monitored so that doctors can study their immune~     systems to try to learn more about this rise and fall in viral load.~   "
271869|NCT00005018|"~     The purpose of this study is to see if it is safe and effective to give HIV-positive patients~     a combination of anti-HIV drugs (abacavir [ABC] plus efavirenz [EFV] plus didanosine [ddI])~     with and without hydroxyurea (HU).~   "
271870|NCT00005017|"~     The purpose of this study is to see how effective and safe it is to give 1 of the 3 following~     treatments to patients who may not have received anti-HIV treatment: 1) lamivudine~     (3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir~     (APV)/ritonavir (RTV).~   "
271871|NCT00005012|"~     The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to~     HIV-infected patients who are not doing well with their current anti-HIV drug combination~     (HAART).~   "
271872|NCT00005010|"~     The purpose of this study is to see how effective 2 drugs, irbesartan and pravastatin, are at~     slowing kidney transplant failure.~      Many kidney transplant patients have some type of chronic rejection. Chronic rejection is a~     disease that causes scarring and damage to the kidney. Over time, chronic rejection can lead~     to kidney failure, making it necessary for patients to start dialysis and possibly receive~     another kidney transplant. Doctors would like to see whether irbesartan and pravastatin can~     slow this damage and prevent kidney failure in patients with signs of chronic rejection.~   "
271873|NCT00005009|"~     The purpose of this study is to find out whether Varivax is safe for use in children with~     kidney transplants and whether it protects children from serious infection. Varivax is a~     vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella)~     and shingles (zoster).~      Healthy children are already receiving Varivax shots to protect them from chickenpox. Few~     children with kidney transplants have received Varivax because doctors have been concerned~     that Varivax might cause serious reactions in them. On the other hand, VZV infection can be a~     life-threatening disease in these children. For this reason, doctors ultimately want to learn~     whether Varivax might safely prevent VZV infections in children who have had kidney~     transplants.~   "
271874|NCT00005002|"~     The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the~     anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.~   "
271875|NCT00005001|"~     The purpose of this study is to see if giving HIV-positive patients an HIV vaccine plus~     anti-HIV drugs can help lower HIV levels in the blood (viral load).~   "
271876|NCT00005000|"~     The purpose of this study is to compare two drugs (nelfinavir [NFV] and efavirenz [EFV]) used~     in start-up anti-HIV treatment. Doctors want to see if one is better than the other in~     extending the time that viral load (level of HIV in the blood) is kept low. The study will~     also look at the response of the immune system to each drug.~   "
271877|NCT00004999|"~     The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug~     (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus~     lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.~   "
271878|NCT00004998|"~     The purpose of this study is to see if two different doses of AG1549 plus other anti-HIV~     drugs are safe and effective in HIV-infected patients who are not taking anti-HIV drugs.~   "
271879|NCT00004987|"~     The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in~     AIDS patients who have failed conventional anti-HIV treatment.~   "
271880|NCT00004986|"~     The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in~     AIDS patients with nitazoxanide.~   "
271881|NCT00004985|"~     The purpose of this study is to look at the effectiveness of an anti-HIV drug combination~     that adds capravirine in patients who have failed their first drug combination treatment.~   "
271882|NCT00004981|"~     The purpose of this study is to look at the safety and effectiveness of a pill called~     Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and~     abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this~     study, Trizivir will be compared to Combivir plus abacavir.~   "
271883|NCT00004978|"~     The purpose of this study is to see if it is effective to give HIV positive patients~     recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed~     over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease~     progression.~      Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping~     viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the~     body of the virus, and the immune system is never completely restored in HIV positive~     patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to~     their anti-HIV therapy will help improve their immune systems and keep them healthier over a~     longer period of time. rIL-2 is a hormone naturally produced by the body during an immune~     response to a microbial infection.~   "
271884|NCT00004855|"~     This study will compare an anti-HIV drug combination of protease inhibitor plus a~     nonnucleoside reverse transcriptase inhibitor (NNRTI) to one that includes three nucleoside~     reverse transcriptase inhibitors (NRTIs) plus an NNRTI. NNRTIs, NRTIs, and protease~     inhibitors are all types of anti-HIV drugs that block the virus in some way.~      This study will try to find out if a treatment regimen containing a protease inhibitor plus~     an NNRTI has a different effect on the rise of CD4 cells compared to a treatment made up of~     three NRTIs plus an NNRTI. CD4 cells are cells of the immune system that fight infection.~     This study will also try to see if the combination of drugs used in this study is safe to use~     in HIV-positive patients.~   "
271885|NCT00004852|"~     The purpose of this study is to look at the safety and effectiveness of receiving lamivudine~     (3TC) once a day versus twice a day as part of an anti-HIV drug combination.~   "
271886|NCT00004736|"~     The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective~     in lowering levels of HIV and boosting the immune system in HIV-infected patients with~     tuberculosis (TB).~      HIV-infected patients with TB have higher levels of HIV and lower CD4 cell counts (cells in~     the body that fight infection) than HIV-infected patients without TB. HAART has been~     effective in reducing HIV levels and increasing CD4 cells in patients without TB. However,~     its effects in HIV-infected patients with TB are unknown.~   "
271887|NCT00004735|"~     The purpose of this study is to determine the number of newly formed CD4 cells in children~     who have taken anti-HIV drugs. The study will also evaluate the effectiveness of the new CD4~     cells in producing an immune response to hepatitis A and tetanus toxoid vaccination.~      Study hypothesis: 1) Immunologic reconstitution of individuals who have less than 15% CD4~     cells may or may not be associated with functional activity. 2) The functional immunologic~     responses to recall and newly experienced antigens may be different. 3) The functional~     responses to antigens delivered in vaccine format may be a function of CD4 level, viral load,~     or both.~   "
271888|NCT00004585|"~     The purpose of this study is to see if a certain combination of anti-HIV drugs is safe and~     effective in HIV-infected patients. The drug combination includes a tablet containing~     lamivudine and zidovudine (called Combivir) plus abacavir plus efavirenz.~   "
271889|NCT00004584|"~     The purpose of this study is to look at the safety and effectiveness of an experimental~     protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an~     anti-HIV drug combination that includes BMS-232632 to a drug combination that includes~     ritonavir.~   "
271890|NCT00004583|"~     The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it~     fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more~     virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with~     another PI, nelfinavir (NFV).~      Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at~     fighting HIV infection.~   "
271891|NCT00004582|"~     The purpose of this study is to see if ABT-378/ritonavir plus efavirenz is safe and effective~     in lowering the amount of HIV in the blood of patients who have been treated with more than 1~     protease inhibitor (PI).~   "
271892|NCT00004581|"~     The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug~     combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2~     nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI).~     One combination will include a new protease inhibitor, ABT-378, combined in a capsule with~     ritonavir (RTV).~   "
271893|NCT00004580|"~     The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir~     combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected~     patients who previously have taken protease inhibitors. This study also examines how the body~     handles this combination of anti-HIV drugs.~   "
271894|NCT00004579|"~     The purpose of this study is to see whether an HIV vaccine, ALVAC vCP205, is safe and can~     prevent HIV infection. The vCP205 vaccine will be tested with another vaccine, gp160MN/LAI-2.~   "
271895|NCT00004578|"~     To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when~     administered orally in antiretroviral-HIV-1 infected subjects.~   "
271896|NCT00002453|"~     This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil~     fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the~     drug causes.~   "
271897|NCT00002452|"~     The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with~     indinavir and if it works well at lowering the level of HIV in the blood (viral load).~   "
271898|NCT00002451|"~     The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV)~     in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have~     never received anti-HIV therapy. This study will look at the effectiveness of this drug~     combination and side effects.~   "
271899|NCT00002450|"~     The purpose of this study is to see if giving tenofovir DF plus a combination of other~     anti-HIV drugs is safe and effective.~   "
271900|NCT00002449|"~     The purpose of this study is to see if it is safe and effective to give HIV-positive patients~     L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance~     naturally produced by the body's white blood cells that plays an important role in helping~     the body fight infection. IL-2 may be able to boost the immune systems of people with HIV~     infection.~   "
271901|NCT00002448|"~     The purpose of this study is to examine how the immune systems of HIV-infected patients react~     to 2 anti-HIV drug combinations.~   "
271902|NCT00002447|"~     The purpose of this study is to compare 2 anti-HIV drug combinations.~   "
271903|NCT00002446|"~     The purpose of this study is to compare the safety and effectiveness of 2 treatments for~     thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is~     a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared~     to fluconazole.~   "
271904|NCT00002445|"~     The purpose of this study is to see if it is safe and effective to use IM862 to treat~     Kaposi's sarcoma (KS) in AIDS patients.~   "
271905|NCT00002444|"~     To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients~     with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ~     following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these~     patients.~      Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing~     substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits~     antimicrobial activity that may extend to Cryptosporidial infection.~   "
271906|NCT00002443|"~     To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT~     administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.~   "
271907|NCT00002442|"~     The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules~     (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either~     indinavir (IDV) or nelfinavir (NFV) for 24 weeks.~   "
272189|NCT00002158|"~     The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients~     suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium).~   "
271912|NCT00002437|"~     To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can~     extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS~     patients. To evaluate the safety and tolerance of HPMPC therapy when administered by~     intravenous infusion in AIDS patients with CMV retinitis that is not immediately~     sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV~     shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual~     acuity.~   "
271913|NCT00002436|"~     To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in~     combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination~     with AZT.~      PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label~     combination therapy.~   "
271914|NCT00002435|"~     To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load~     based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its~     persistence when administered in combination with an antiretroviral nucleoside derivative~     (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and~     progression of disease.~   "
271915|NCT00002434|"~     To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in~     patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated~     severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral~     pentamidine).~   "
271916|NCT00002433|"~     To determine safety and tolerance of administering aerosolized recombinant interferon gamma~     (IFN-gamma) for 4 weeks in patients with AIDS. To examine activation of alveolar macrophages~     by aerosolized IFN-gamma administration. To determine if subcutaneous (SC) injection of~     IFN-gamma can activate alveolar macrophages in AIDS patients.~   "
271917|NCT00002432|"~     To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS~     patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the~     safety and efficacy of foscarnet maintenance therapy for treatment of AIDS patients~     experiencing CMV retinitis.~   "
271918|NCT00002431|"~     To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine~     gluconate) for preventing the occurrence of clinically-evident microbiologically-documented~     oral candidiasis in HIV-positive patients, who are at risk of the disease based on previous~     history of candidiasis.~   "
271919|NCT00002430|"~     The purpose of this study is to compare two different anti-HIV drug combinations, one that~     contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV)~     also will be studied.~   "
271920|NCT00002429|"~     This study tests a new form of didanosine, ddI EC, a coated pill that passes through the~     stomach before dissolving. The purpose of this study is to compare the effectiveness of an~     anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.~   "
271921|NCT00002428|"~     To evaluate the safety and immunogenicity of a combination of microparticulate monovalent~     HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent~     HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in~     intermediate or higher risk HIV-negative volunteers.~   "
271922|NCT00002427|"~     The purpose of this study is to compare the safety and effectiveness of 9 doses of HU in~     order to find the best dose of HU to use with ddI and d4T in fighting HIV infection.~      HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control~     of HIV. This combination can sharply decrease viral load (level of HIV in the body) with few~     side effects, making it easy to take.~   "
271923|NCT00002426|"~     The purpose of this study is to see if it is safe and effective to give an experimental~     anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to~     patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.~   "
271924|NCT00002425|"~     To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule~     formulation (SQV-SGC) in combination with other antiretroviral drugs.~   "
271925|NCT00002424|"~     This study will see how safe and effective against HIV the drugs L-756423 plus indinavir~     (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The~     study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and~     effective as taking 2 smaller doses twice a day.~   "
271926|NCT00002423|"~     This study will compare the safety and effectiveness of two anti-HIV drug combinations in~     fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with~     other anti-HIV drug treatments.~   "
271927|NCT00002422|"~     The purpose of this study is to see if it is safe and effective to give HE2000, an~     experimental anti-HIV drug, to HIV-infected patients on salvage therapy (emergency treatment~     used when a patient has not responded to standard therapy).~      HE2000 is a hormone that is suspected to make it more difficult for HIV to live in cells.~   "
271928|NCT00002420|"~     The purpose of this study is to see if it is safe and effective to give MKC-442, didanosine~     (ddI), stavudine (d4T), and delavirdine (DLV) to HIV-positive patients.~   "
271929|NCT00002419|"~     The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil~     plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who~     have failed to respond to previous treatment with protease inhibitors (PIs).~   "
271930|NCT00002418|"~     The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug~     combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase~     inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug~     combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus~     MKC-442. Hydroxyurea (HU) may be added.~   "
271931|NCT00002417|"~     The purpose of this study is to see if it is safe and effective to give the protease~     inhibitor (PI) amprenavir (APV) to patients with fat production and distribution problems~     associated with other PIs.~      Protease inhibitors are very effective in treating HIV-1 disease. However, patients who take~     these drugs often have problems, such as hyperlipidemia (an increased level of fat in the~     blood) and lipodystrophy (problems with the way fat is produced and distributed in the body).~     Doctors do not know exactly how PIs are related to these problems. APV has been shown to be~     safe and effective in lowering plasma viral loads (level of HIV in the blood). APV may be~     useful for patients who develop complications associated with other PIs.~   "
271935|NCT00002413|"~     The purpose of this study is to see if it is safe and effective to give MKC-442 plus at least~     two other anti-HIV drugs to patients who have never been treated with nonnucleoside reverse~     transcriptase inhibitors but who have been treated with nucleoside reverse transcriptase~     inhibitors and protease inhibitors. This study also determines how long a drug combination~     including MKC-442 is effective.~   "
271936|NCT00002412|"~     The purpose of this study is to see if it is safe and effective to give MKC-442 plus~     stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.~   "
271937|NCT00002411|"~     The purpose of this study is to compare the safety of didanosine plus stavudine plus~     nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines~     how long these drug combinations are effective in lowering viral load (level of HIV in the~     blood).~   "
271938|NCT00002410|"~     The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug~     combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266~     plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study~     also examines the resistance HIV may have to these drugs and if these drugs are effective~     over a long period of time.~   "
271939|NCT00002409|"~     The purpose of this study is to see if an HIV-education course can help under-represented,~     HIV-infected patients. This study examines the areas of faithfulness to drug regimen, level~     of HIV in the blood, and health status.~   "
271940|NCT00002408|"~     To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool~     weight in AIDS patients with diarrhea over 6 days of treatment.~   "
271941|NCT00002407|"~     The purpose of this study is to see if it is safe and effective to give one of three~     different triple-drug combinations to HIV-infected patients who have never been treated with~     anti-HIV drugs.~   "
271942|NCT00002406|"~     The purpose of this study is to determine if two dose levels of indinavir combined with two~     nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma~     viral load (level of HIV in the blood).~   "
271943|NCT00002405|"~     The purpose of this study is to see if it is safe to give amprenavir (APV) to HIV-infected~     patients. This study also examines the effect APV has on the level of HIV in the blood.~      Earlier studies have shown that APV is effective in slowing the growth of HIV in the body.~     Patients who have failed previous anti-HIV treatment or who are unable to take other protease~     inhibitors (PIs) may benefit from the availability of a new PI such as APV.~   "
271944|NCT00002404|"~     The purpose of this study is to see if valacyclovir affects the detection of HIV in genital~     herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital~     herpes.~   "
271945|NCT00002403|"~     The purpose of this study is to see if it is safe and effective to give zintevir (AR177) to~     asymptomatic (no symptoms) HIV-infected patients.~      Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. HIV uses the~     protein integrase to infect a cell. Integrase inhibitors block integrase and may stop~     replication of HIV.~   "
271946|NCT00002402|"~     The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or~     AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.~   "
271947|NCT00002401|"~     The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in~     combination with two or three other drugs to HIV-infected patients. The drugs to be used in~     combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).~   "
271948|NCT00002400|"~     The purpose of this study is to compare the safety and effectiveness of giving HIV-infected~     patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus~     IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is~     given in combination with other drugs.~   "
271949|NCT00002399|"~     The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that~     of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive~     patients.~   "
271950|NCT00002398|"~     The purpose of this study is to see if it is safe and effective to give adefovir plus other~     anti-HIV drugs to HIV-infected patients who have failed other anti-HIV drug combinations.~     This study will try to make adefovir available to all AIDS patients who need it.~      Some patients do not respond to anti-HIV drug combinations, even when different combinations~     are tried. Adefovir may be able to help these patients fight HIV.~   "
271951|NCT00002397|"~     The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus~     stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in~     patients with HIV-associated kidney disease. This study examines whether these drug~     combinations are effective in preventing kidney disease from progressing to a stage where it~     is immediately life threatening. This study also examines the effect these drug combinations~     have on the level of HIV detected in these patients. Finally, this study evaluates the drug~     level (the amount of drug found in the body) of these two combinations in patients with~     kidney disease.~   "
271952|NCT00002396|"~     To evaluate the safety of single and multiple doses (28 daily doses) of~     9-[2-(R)-[[bis[[(isopropoxycarbonyl)- oxy]methoxy]phosphinoyl]methoxy]propyl]adenine fumarate~     (PMPA) prodrug administered orally to HIV-infected patients. To determine the~     pharmacokinetics of single and multiple doses of PMPA prodrug when administered orally to~     HIV-infected patients. To evaluate the anti-HIV activity of PMPA prodrug, as demonstrated by~     increases in CD4 cell counts and decreases in HIV RNA, when administered orally as a single~     dose and daily for 4 weeks to HIV-infected patients with CD4 cell counts of 200 or more~     cells/mm3.~   "
271953|NCT00002395|"~     The purpose of this study is to see if it is safe and effective to give topotecan through a~     vein to treat HIV-infected patients with PML, an opportunistic (AIDS-related) infection~     caused by a virus that infects brain tissue and causes damage to the brain and the spinal~     cord.~      Topotecan fights HIV and the JC virus (the virus that causes PML) in laboratory experiments.~   "
271954|NCT00002394|"~     The purpose of this study is to see if it is safe and effective to give Lamisil to~     HIV-positive patients with thrush (a fungal infection) that has not responded to fluconazole.~   "
271955|NCT00002393|"~     The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV~     treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).~   "
271957|NCT00002391|"~     To compare the safety, tolerance, durability of the viral load response and the antiviral~     activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To~     determine the clinical efficacy of the two regimens as measured survival, disease~     progression, weight growth velocity, and neuropsychological or neurological changes. To~     assess the development of viral resistance and relative pharmacokinetics associated with each~     regimen.~   "
271958|NCT00002390|"~     The purpose of this study is to see if giving 1592U89 to HIV-infected patients is safe and~     effective in lowering viral load (level of HIV in the blood) and raising the level of CD4~     cells (cells of the body that help fight infection).~   "
271959|NCT00002389|"~     To compare the durability of the viral load response following 48 weeks of treatment with~     1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early~     antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as~     demonstrated by the proportion of subjects with viral load < 400 copies/ml, plasma HIV-1 RNA~     profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of~     treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone.~   "
271960|NCT00002388|"~     The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients.~     This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the~     blood).~   "
271961|NCT00002387|"~     To estimate the differences in parameters of antiviral activity and safety between a control~     regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose~     indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease~     inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive~     patients.~      It is hypothesized that after 16 weeks of randomized treatment with either the control or~     experimental regimen that:~        1. The observed proportion of patients with serum viral RNA < 400 copies/ml in the~          experimental and control regimen will be similar and will continue to be so after 48~          weeks.~        2. The safety profiles of the two groups will be similar, judged by the incidence of~          serious, drug-related adverse experiences and the incidence of events of specific~          interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and~          CNS-related symptoms) and will continue to be so after 48 weeks.~        3. The two groups will be similar with respect to changes from baseline in serum viral RNA~          and CD4 counts and will continue to be so after 48 weeks.~   "
271962|NCT00002386|"~     The purpose of this study is to see if indinavir plus two other anti-HIV drugs affect blood~     clotting in HIV-positive patients with hemophilia.~   "
271963|NCT00002385|"~     To identify doses of fozivudine tidoxil that are well tolerated and produce measurable~     antiviral activity.~      To identify the adverse event profile that defines the maximum tolerated dose. To~     characterize the single- and multiple-dose pharmacokinetics of fozivudine and its~     metabolites.~      To correlate the adverse event profile and antiviral activity of fozivudine with~     pharmacokinetic parameters.~   "
271964|NCT00002384|"~     Incomplete Closed Protocol~   "
271965|NCT00002383|"~     To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel~     capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation~     administered orally every 8 hours for 4 weeks.~   "
271966|NCT00002382|"~     To offer an investigational agent (saquinavir) to people with HIV/AIDS who are in need of~     additional treatment options and are not eligible to enroll in ongoing clinical trials.~      Patients who no longer benefit from existing antiretroviral therapy and who are not currently~     enrolled in ongoing saquinavir trials are eligible for this compassionate treatment program.~   "
271967|NCT00002381|"~     To determine the potential effects of 28 days of nevirapine treatment on the steady-state~     pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the~     pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the~     historical controls treated with nevirapine but without nelfinavir or d4T. To determine the~     efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in~     patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease~     inhibitor naive, and have <= 6 months prior d4T exposure at the time of screening.~   "
271968|NCT00002380|"~     To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of~     saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in~     combination with nelfinavir and nucleoside antiretroviral drugs (part 2), in HIV-infected~     infants and children.~   "
271969|NCT00002379|"~     To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally~     in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4~     cell counts >= 100 cells/mm3 and an HIV-1 RNA baseline copy number >= 5000 copies/ml. To~     determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of~     detection (500 copies/ml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA~     from baseline through study week 20. To evaluate the durability of the antiviral response~     through 48 weeks of study in patients who continue on study therapy after week 24.~   "
271970|NCT00002378|"~     To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of~     detection (< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in~     plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the~     treatment regimens.~      AS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir)~     Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus~     FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus~     FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose~     plasma HIV-1 RNA level falls below the Amplicor assay level of detection (< 400 copies/ml) at~     week 24 and week 48.~   "
271971|NCT00002377|"~     To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients~     with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance~     level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the~     pharmacokinetics of ganciclovir following administration of RS-79070 in the target~     population.~   "
271997|NCT00002351|"~     To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate~     ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the~     plasma concentration profile after the initial dose with data from a historical group of~     adults. To obtain preliminary data on antiviral activity of MK-639.~   "
271972|NCT00002376|"~     To evaluate, in HIV-infected patients whose baseline CD4 count is 300 to 750 cells/mm3,~     whether an antiretroviral treatment regimen based upon clinical evaluation and CD4 counts~     plus HIV RNA viral load is more effective than a treatment regimen based upon clinical~     evaluation and CD4 counts without the use of HIV RNA viral load information. To assess~     relative utility of viral load testing in determining therapeutic choice by the surrogate~     marker of CD4 cell counts after 48 weeks of therapy.~      It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range~     of 300 to 750 cells/mm3, those patients who incorporate initial and periodic viral RNA~     measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than~     patients whose therapeutic decisions do not incorporate initial and periodic viral RNA~     measurements.~   "
271973|NCT00002375|"~     The purpose of this study is to see if it is safe and effective to treat HIV-infected~     patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications.~      It is thought that IDV plus NFV will be a safe drug combination for treating HIV.~   "
271974|NCT00002374|"~     To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other~     antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel~     capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study~     treatment.~   "
271975|NCT00002373|"~     To evaluate the safety and tolerability of multiple escalating doses of 1263W94 administered~     orally for 28 days in HIV infected patients with asymptomatic CMV shedding. To obtain~     preliminary evidence of the in vivo anti CMV activity of different doses of 1263W94 in humans~     based on quantitative reduction of CMV load in semen and if possible in other biological~     fluids and to explore the dose response relationship in the anti-CMV activity of 1263W94.~   "
271976|NCT00002372|"~     To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir,~     indinavir and nelfinavir after multiple oral dosing. To determine the steady-state~     pharmacokinetics of saquinavir, indinavir, and nelfinavir in combination with 141W94 after~     multiple oral dosing. To assess the safety and tolerability of multiple doses of 141W94 when~     combined with saquinavir, indinavir and nelfinavir.~   "
271977|NCT00002371|"~     To compare the magnitude and durability of the reduction in plasma HIV RNA in the two~     treatment groups over the first 12 weeks of treatment. To determine the safety of each of the~     two treatment groups.~   "
271978|NCT00002370|"~     To demonstrate a dosage regimen for intravenous itraconazole that produces a plasma~     concentration range comparable to that obtained after currently used oral dosages of~     itraconazole oral solution; and to obtain preliminary safety data in patients with advanced~     HIV disease.~   "
271979|NCT00002369|"~     To evaluate the tolerance, and comparative virologic and immunologic effects of the two~     combination regimens.~   "
271980|NCT00002368|"~     To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS~     progression events or death when used in combination with Lamivudine and background~     nucleoside therapy.~   "
271981|NCT00002367|"~     To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the~     treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.~   "
271982|NCT00002366|"~     To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.~   "
271983|NCT00002365|"~     To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected~     patients.~   "
271984|NCT00002364|"~     To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in~     combination with other specific NRTI agents in NRTI experienced patients and to assess the~     safety and tolerance of multiple oral doses of 1592U89 when administered in combination with~     specific marketed NRTIs.~   "
271985|NCT00002363|"~     To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1~     plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with~     initial viral load above 10,000 copies/ml. To study the safety of SPC3 and the kinetics of~     HIV-1 plasma level changes.~   "
271986|NCT00002362|"~     This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when~     taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV~     drugs.~   "
271987|NCT00002361|"~     The purpose of this study is to see if it is safe and effective to give an anti-HIV drug~     combination containing indinavir and ritonavir to HIV-positive patients who have failed~     previous treatment with protease inhibitors.~   "
271988|NCT00002360|"~     The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe~     and absorbed by the body as well as the chewable-tablet form of ddI.~      Didanosine (ddI) is an anti-HIV drug. The effectiveness of ddI can be lowered by acid in the~     stomach. To prevent this, patients take antacids with ddI. The coated-capsule form of ddI may~     replace the need for antacids.~   "
271989|NCT00002359|"~     To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the~     time prior to development of an AIDS-defining condition or death.~   "
271990|NCT00002358|"~     To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with~     varicella-zoster viral disease who have failed or are intolerant of alternative therapy.~   "
271991|NCT00002357|"~     To obtain preliminary information on the safety, tolerability, and antiretroviral activity of~     HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone.~      PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.~   "
271992|NCT00002356|"~     To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus ( CMV~     ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are~     otherwise ineligible for ISIS Pharmaceuticals' controlled trials OR who have failed ISIS 2922~     therapy on another controlled clinical trial.~      PER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.~   "
271993|NCT00002355|"~     To determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to~     compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with~     previously untreated, peripheral cytomegalovirus ( CMV ) retinitis.~   "
271994|NCT00002354|"~     The purpose of this study is to see if it is safe and effective to give indinavir sulfate~     plus stavudine to HIV-infected patients who have already been treated with zidovudine.~   "
271995|NCT00002353|"~     To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered~     subcutaneously in HIV-seropositive patients.~   "
271998|NCT00002350|"~     To evaluate safety and immune response in HIV-infected patients treated with multiple~     injections of APL 400-003 vaccine.~      PER 2/27/96 AMENDMENT: To evaluate the safety of the vaccine when administered via the~     Biojector 2000 Needle-Free Injection Management System.~      Facilitated DNA inoculation, a new type of DNA vaccine, involves direct injection of~     non-infectious HIV genes into a patient's muscle, along with agents that promote uptake of~     the genes into host cells. Host cells that have taken up these genes then produce viral~     proteins in a form that elicits immune responses in the form of antibodies, killer T-cells,~     and helper T-cells. The safety of this new vaccine approach needs to be assessed.~      PER 2/27/96 AMENDMENT: The Biojector 2000 provides an option for delivering the vaccine~     without a needle and employs a single-use syringe to avoid cross-contamination.~   "
271999|NCT00002349|"~     To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence~     of recent HIV infection.~      Also, to compare the immunologic effects and effects on quality of life of d4T in these~     patients.~   "
272000|NCT00002348|"~     To estimate the response rate, response duration, clinical benefit, and toxicity of~     mitoguazone dihydrochloride (MGBG) in patients with AIDS-related refractory or relapsing~     non-Hodgkin's lymphoma (NHL).~   "
272001|NCT00002347|"~     To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of~     antiretrovirals in patients with HIV infection. Specifically, to evaluate~     zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or~     saquinavir ( Ro 31-8959 ).~      Administration of three-drug combinations for treatment of HIV infection is preferred over~     monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug~     combinations of antiretrovirals and allow the addition of new agents as they become~     available.~   "
272002|NCT00002346|"~     To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV~     activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a~     daily basis for 2 weeks to HIV-infected patients.~   "
272003|NCT00002345|"~     To further evaluate the safety of megestrol acetate (Megace) oral suspension in the treatment~     of anorexia and cachexia in HIV-positive women. To compare the effectiveness of 2 doses of~     Megace by measurement of weight gain, appetite grade, and other parameters at 12 and 24~     weeks.~   "
272004|NCT00002344|"~     To assess the dose proportionality of azithromycin concentrations and toleration when~     delivered in tablet formulation to HIV-infected patients.~      The need exists to further assess the antibacterial agent azithromycin at differing doses in~     an HIV-infected population.~   "
272005|NCT00002343|"~     To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum~     rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to~     examine the effect of combination therapy in preventing or delaying the incidence of MAC~     bacteremia in this patient population.~   "
272006|NCT00002342|"~     To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152)~     and to establish the MTD at each of the different dosing schedules.~   "
272007|NCT00002341|"~     To provide maintenance treatment with itraconazole solution for patients who were clinical~     responders in the ITR-USA-94 protocol, even if they subsequently relapsed.~   "
272008|NCT00002340|"~     To assess whether high dose or low dose atovaquone suspension is more effective than~     aerosolized pentamidine as prophylaxis against Pneumocystis carinii pneumonia (PCP) in~     high-risk HIV-infected patients. To compare the safety of chronic administration of the three~     regimens in patients with advanced HIV disease. To determine the relationship between steady~     state atovaquone plasma concentrations and prophylactic efficacy against PCP.~   "
272009|NCT00002339|"~     To determine the safety, toleration, and efficacy of fluconazole oral suspension in the~     treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.~   "
272010|NCT00002338|"~     To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of~     935U83 administered to patients with HIV infection. To obtain preliminary evidence of~     antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug~     resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.~   "
272011|NCT00002337|"~     To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with~     advanced HIV disease.~   "
272012|NCT00002336|"~     To determine whether clarithromycin is safe and effective in preventing disseminated~     Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.~   "
272013|NCT00002335|"~     To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in~     HIV-infected patients. To determine the effects of food on bioavailability of 524W91.~   "
272014|NCT00002334|"~     To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of~     saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro~     31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different~     regimens.~   "
272015|NCT00002333|"~     To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone,~     zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing~     or unable to take zidovudine (AZT).~   "
272016|NCT00002332|"~     To evaluate the mechanism whereby thymopentin appears to retard the progressive immune~     suppression attributable to HIV infection.~   "
272017|NCT00002331|"~     PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus~     ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium~     Complex (dMAC).~      SECONDARY: To determine the proportion of patients achieving a sterile blood culture along~     with the time required to achieve it. To determine the duration of bacteriological response,~     defined as length of time that blood cultures remain sterile.~   "
272018|NCT00002330|"~     To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three~     doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for~     26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study~     doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.~   "
272125|NCT00002222|"~     The purpose of this study is to see if valganciclovir is a safe treatment for CMV retinitis~     in patients who have been treated for this condition in the past. This study also examines~     the effectiveness of valganciclovir in preventing the recurrence of CMV retinitis.~   "
272019|NCT00002329|"~     To characterize the safety profile of MDL 28574A following both acute and subchronic dosing~     in HIV-positive patients. To determine the MTD of both acute and subchronic doses of this~     drug when administered as oral solution. To determine the pharmacokinetic profile of MDL~     28574A and castanospermine (from which MDL 28574A is derived) following both acute and~     subchronic dosing.~   "
272020|NCT00002328|"~     To provide azithromycin for the treatment of individual patients with proven~     cryptosporidiosis whose disease has persisted or progressed despite prior therapies.~   "
272021|NCT00002327|"~     To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for condyloma~     acuminatum in patients with HIV infection. To investigate whether topical HPMPC therapy can~     induce regression of condyloma acuminatum in patients with HIV infection.~   "
272022|NCT00002326|"~     To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of combination~     zidovudine (AZT) and PMEA (adefovir) therapy.~   "
272023|NCT00002325|"~     To compare the efficacy of fluconazole versus placebo in preventing the development of active~     coccidioidomycosis and other systemic fungal infections among HIV-infected patients with CD4~     lymphocyte counts < 250 cells/mm3 who are living in the coccidioidal endemic area.~   "
272024|NCT00002324|"~     PRIMARY: To compare the effect of nevirapine versus placebo alone or in combination with~     zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To~     evaluate the safety and tolerance of nevirapine alone or in combination with AZT.~      SECONDARY: To compare the effects of the various treatment combinations on virologic and~     immunologic markers.~   "
272025|NCT00002323|"~     PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the~     combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of~     treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.~      SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in~     patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two~     regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two~     regimens.~   "
272026|NCT00002322|"~     To determine the tolerance and antiviral response of two different doses of atevirdine~     mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3,~     who also take zidovudine (AZT).~   "
272027|NCT00002321|"~     To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir,~     antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune~     adjuvant in HIV-seropositive patients. To investigate the effect of increasing doses of~     Proleukin on the time to progression of CMV retinitis in patients being treated with~     therapeutic ganciclovir and antiretroviral therapy. To evaluate the incidence and level of~     anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient~     population.~   "
272028|NCT00002320|"~     To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine~     (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected~     patients.~      PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label~     combination therapy.~   "
272029|NCT00002319|"~     To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride~     (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who~     previously had good responses to DOX-SL in controlled studies of limited duration, or those~     with KS who discontinued treatment with another Kaposi's sarcoma therapy because of~     inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's~     sarcoma patients for whom DOX-SL therapy is indicated.~   "
272030|NCT00002318|"~     To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the~     treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established~     therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and~     tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.~   "
272031|NCT00002317|"~     To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in~     pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have~     demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or~     parenteral pentamidine).~   "
272032|NCT00002316|"~     To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV~     infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the~     pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when~     administered with RMP-7.~   "
272033|NCT00002315|"~     To determine the efficacy of oral 882C87 compared with oral acyclovir in the treatment of~     localized herpes zoster in immunocompromised patients. To assess the safety and tolerance of~     oral 882C87 in immunocompromised patients.~   "
272034|NCT00002314|"~     To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's~     sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic~     effects of Ro 24-7429 in this patient population. To explore relationships between exposure~     to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug~     toxicity.~   "
272035|NCT00002313|"~     To evaluate the clinical toxicity, safety, and potential anti-HIV activity of intravenous~     nystatin in patients with HIV infection who have completed protocol FDA 103C. To evaluate the~     safety and potential antiviral activity of intravenous nystatin and oral didanosine (ddI)~     administered in an alternating regimen in this patient population.~   "
272036|NCT00002312|"~     To evaluate the pharmacokinetics, safety, and tolerance of delavirdine mesylate ( U-90152 )~     after multiple doses given orally to asymptomatic HIV-1 positive patients who are maintained~     on a stable dose of zidovudine ( AZT ). To investigate the optimum dose regimen of U-90152~     that gives average trough concentrations > 1 micromolar in combination with standard AZT~     therapy, and to examine drug interactions between the two drugs. To establish the MTD of~     U-90152 in HIV-1 positive patients on stable AZT therapy. To investigate comparative~     pharmacokinetics between HIV-1 positive men and women.~   "
272037|NCT00002311|"~     To study the safety and efficacy of four different doses of Wobenzym (an enzyme combination~     consisting of pancreatin, papain, bromelain, trypsin, lipase, amylase, chymotrypsin, and~     rutin) in patients with HIV infection whose CD4 count is between 250 and 400 cells/mm3. To~     evaluate the effect of Wobenzym on certain surrogate markers associated with progression of~     HIV disease.~   "
272038|NCT00002310|"~     To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To~     observe the effect of this drug on herpes simplex virus lesions in patients who have failed~     to heal in response to oral or intravenous acyclovir therapy.~      The lack of alternative treatments for herpes simplex virus infection in patients with AIDS~     and the development of resistance to acyclovir for patients requiring repeated treatment~     presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against~     resistant strains and offers a convenient and inexpensive means of drug administration in~     comparison to the use of intravenous medication.~   "
272039|NCT00002309|"~     To evaluate the efficacy and safety of azithromycin administered once a week in the~     prevention of disseminated Mycobacterium avium complex (MAC) in severely immunocompromised~     HIV-infected patients with a CD4 count < 100 cells/mm3.~   "
272040|NCT00002308|"~     To make stavudine (d4T) available to patients with advanced HIV disease for whom no~     alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose~     levels in a twice-daily regimen.~   "
272041|NCT00002307|"~     To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To~     compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen~     and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes~     over time in laboratory parameters associated with HIV infection. To compare the safety of~     oral doses of d4T to AZT in patients with HIV infection.~   "
272042|NCT00002306|"~     To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal~     meningitis in patients who have had an unsatisfactory response to or have experienced~     unacceptable toxicity with amphotericin B.~   "
272043|NCT00002305|"~     To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in~     combination with flucytosine, as treatment for acute cryptococcal meningitis.~   "
272044|NCT00002304|"~     To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the~     treatment of candidal esophagitis in immunocompromised patients.~   "
272045|NCT00002303|"~     To determine the safety and efficacy of erythropoietin administered to patients with AIDS or~     advanced AIDS related complex ARC and anemia.~   "
272046|NCT00002302|"~     To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS~     patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.~     Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.~   "
272047|NCT00002301|"~     To evaluate the safety and efficacy of foscarnet induction treatment of cytomegalovirus (CMV)~     retinitis in AIDS patients who have previously suffered severe dose-limiting~     ganciclovir-related myelosuppression, who are ineligible for ganciclovir treatment due to~     myelosuppression or who have clearly failed to have a therapeutic response to ganciclovir~     therapy. To assess the duration of clinical response. To evaluate the effect on quantitative~     CMV cultures of blood and urine. To determine the effect on recovery of HIV p24 antigen~     capture direct from plasma.~   "
272048|NCT00002300|"~     To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia,~     calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS. To~     characterize dose response in relation to weight gain. To determine whether megestrol acetate~     relative to placebo improves the perception of well-being among AIDS patients with cachexia.~     To evaluate megestrol acetate's effect on immune function via skin test reactivity, T4/T8~     ratio, and total lymphocytes.~   "
272049|NCT00002299|"~     The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of~     cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that~     30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a~     common dose-limiting problem in about 50 percent of patients. Since in vitro data have~     suggested that there is synergism between DHPG and interferon beta against cytomegalovirus, a~     reduced dose of DHPG in combination with a low dose of interferon beta may prevent relapse~     without causing neutropenia. If remission can be maintained with low-dose DHPG and interferon~     beta, maintenance therapy with a moderate dose of interferon beta alone will be evaluated in~     a subsequent protocol.~   "
272050|NCT00002298|"~     The objective of this clinical trial is to determine whether long-term oral dosage of~     ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who~     are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy~     syndrome (CDC classification group III), or who have clinical symptoms but not severe HIV~     disease as defined by CDC classification, and whether the dosage regimen is safe and~     tolerable in these subjects.~   "
272051|NCT00002297|"~     The objectives of this study are to determine the effects of isoprinosine in patients~     diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will~     include:~      Signs and symptoms:~        -  Lymphadenopathy.~        -  Fever.~        -  Weight loss.~        -  Occurrence of opportunistic infections.~      Cell-mediated immune system parameters:~        -  T-helper cell (OKT4) numbers and proportions.~        -  T-suppressor cell (OKT8) numbers and proportions.~        -  Natural killer (NK) cell activity.~        -  Lymphocyte blastogenic response to phytohemagglutinin (PHA).~        -  Lymphocyte blastogenic response to pokeweed mitogen (PWM).~        -  Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.~        -  Circulating immune complexes. Infections characteristically associated with AIDS, such~          as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex,~          Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium-~          intracellulare, Legionella, and Isospora.~      Safety parameters:~        -  Blood chemistry including serum uric acid (PurposeA-12).~        -  Complete blood count (CBC).~        -  Platelet count.~   "
272052|NCT00002296|"~     The objective of this Phase III, randomized, double-blind, placebo-controlled study in~     patients with immunologic deficiency is to determine the effect of Isoprinosine in producing~     an immuno-restorative response within the study observation period (including the 2-month~     period following cessation of the 28 days of treatment), measured by one or more of the~     following immunological parameters:~        -  Increase in natural killer (NK) cell activity.~        -  Increase in total T-cells (OKT-11).~        -  Increases in absolute number and percentage of T-helper cells (OKT-4).~   "
272217|NCT00002130|"~     To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected~     patients who have completed a short-term study (less than 12 months on continuous treatment)~     of the drug.~   "
272053|NCT00002295|"~     To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to:~      Laboratory (immunologic defects):~        -  Comparison of total helper and suppressor T-cell numbers among the groups.~        -  Comparison of changes in natural killer cell activity.~        -  Comparison of other laboratory findings among the groups.~      Clinical changes:~        -  Comparison of the frequency of opportunistic infections among the groups.~        -  Comparison of the frequency of the development of AIDS-related malignancies.~        -  Comparison of other clinical manifestations relative to severity and time of onset.~   "
272054|NCT00002294|"~     To compare the safety and effectiveness of fluconazole with that of placebo as maintenance~     treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.~   "
272055|NCT00002293|"~     To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the~     prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (group III or~     IV, CDC classification)~   "
272056|NCT00002292|"~     To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis~     carinii pneumonia (PCP) with AIDS.~   "
272057|NCT00002291|"~     To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of~     1 of 3 doses of aerosol pentamidine when used as a prophylactic agent in patients who have~     recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).~   "
272058|NCT00002290|"~     This double-blind, placebo-controlled study is designed to determine the long-term safety and~     efficacy of concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy~     alone, in the treatment of early symptomatic HIV infection. Efficacy will be evaluated by~     monitoring the incidence, severity, and time of development of opportunistic infections and~     other manifestations of advanced symptomatic HIV infection. The effects of the combination~     and single AZT therapy on immune function and viral replication will also be evaluated. Study~     participants will be monitored for evidence of toxicity or intolerance to concurrent AZT /~     ACV administration and AZT therapy alone.~   "
272059|NCT00002289|"~     Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus~     isolation. Examine the ability of thymopentin to stimulate the immune system and alter the~     clinical findings in patients infected with HIV who do not yet have AIDS.~   "
272060|NCT00002288|"~     To assess the efficacy of Retrovir (AZT) therapy in the treatment of HIV Ab positive persons~     with impairments in neuropsychological functioning. To assess the safety, virologic, and~     immunologic effects of AZT therapy in HIV Ab positive persons with neuropsychological~     impairment but minimal other symptomatology.~   "
272061|NCT00002287|"~     To evaluate the safety and effectiveness of Retrovir (AZT) when used as prophylaxis for~     health care workers at risk for HIV infection from exposure to HIV-contaminated blood or~     blood components.~   "
272062|NCT00002286|"~     To evaluate the feasibility of Retrovir (AZT) in the treatment of psoriasis in HIV antibody~     positive patients. Retrovir has been shown to be effective in the treatment of AIDS. In~     addition, the administration of AZT appears to have induced a remission of psoriasis in one~     case study. In light of AZT's antiviral activity and potential effectiveness as an agent for~     the treatment of psoriasis, this would be the most likely treatment for HIV positive,~     psoriatic patients whose disease progresses quickly.~   "
272063|NCT00002285|"~     To determine the safety and efficacy of zidovudine (AZT) treatment combined with syngeneic or~     HLA identical allogeneic lymphocyte transfer in the presence of interleukin 2 (IL-2) as a~     treatment for AIDS. Patients with documented HIV viremia will be evaluated. Effects on virus~     replication, immune function, and clinical condition will be monitored with periodic virus~     cultures, estimates of lymphocyte type and numbers, cell surface markers, in vitro lymphocyte~     responses and frequent clinical evaluations.~   "
272064|NCT00002284|"~     To determine whether zidovudine (AZT) in conjunction with bone marrow transplantation~     prevents the reinfection of donor hematopoietic/lymphoid cells in patients with positive HTLV~     III antibody and large cell/diffuse histiocytic lymphoma. Patients who are candidates will be~     evaluated for HTLV III activity and drug levels.~   "
272065|NCT00002283|"~     Evaluate the effectiveness rate of dapsone plus trimethoprim as a therapy for the first~     episode of Pneumocystis carinii pneumonia (PCP) in AIDS patients. Compare the rates and~     severity of adverse effects using dapsone versus trimethoprim - sulfamethoxazole (TMP /~     PurposeX). Establish relative toxicities with regard to suitability for outpatient treatment.~   "
272066|NCT00002282|"~     To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14~     days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal~     candidiasis in patients with AIDS.~   "
272067|NCT00002281|"~     To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte~     colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and~     concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe~     AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of EPO~     given 3 times weekly by SC injection concomitantly with G-CSF and prior to and concomitantly~     with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of 3 dose~     levels of AZT given to patients with AIDS or severe ARC concomitantly treated with G-CSF and~     EPO. To study the effect of G-CSF alone and in combination with EPO on HIV replication in~     vivo as measured by circulating HIV p24 antigen, plasma HIV viremia and semiquantitative HIV~     cocultures.~   "
272068|NCT00002280|"~     The purpose of this study is to make didanosine (ddI) available to children with AIDS who are~     clinically deteriorating on zidovudine (AZT) or intolerant to AZT and cannot enter the Phase~     II ddI programs due to protocol exclusion or geographic location.~   "
272069|NCT00002279|"~     AMENDED: To provide ddC for patients with AIDS or advanced ARC who have failed treatment~     with, are intolerant to or are ineligible to receive zidovudine (AZT) and to demonstrate that~     ddC monotherapy is safe, and tolerable in this patient population.~      Original design: To provide zalcitabine (dideoxycytidine; ddC) for patients with AIDS or~     advanced AIDS-related complex (ARC) who have failed treatment with or are intolerant to~     zidovudine (AZT) and who are also intolerant to dideoxyinosine (ddI); to demonstrate that ddC~     monotherapy is safe and tolerable in the treatment of patients who previously experienced~     either treatment failure, hematologic intolerance or myositis with AZT treatment and~     pancreatitis or other toxicities (except peripheral neuropathy with ddI).~   "
272070|NCT00002278|"~     To evaluate the safety and efficacy of diclazuril capsules as a treatment for cryptosporidial~     related diarrhea in AIDS patients who have been treated in the double-blind study # JRD~     64,433/1101 and have relapsed, or de-novo patients who have been diagnosed with~     cryptosporidial related diarrhea and who meet the inclusion and exclusion criteria of this~     protocol.~   "
272071|NCT00002277|"~     To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment~     for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal~     infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS~     related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they~     also have a malignancy.~   "
272072|NCT00002276|"~     To determine if platelet dysfunction and/or pharmacologic drug interaction occurs in patients~     taking both AZT and ibuprofen, which might account for enhanced bleeding tendency.~   "
272073|NCT00002275|"~     The objectives of this study are:~      To establish whether there is a difference in clinical effectiveness of Liposyn II 20 percent~     as compared with Liposyn III 2 percent in AIDS patients with Pneumocystis carinii pneumonia~     (PCP). To compare the effects of the two lipid emulsions on immunologic function in AIDS~     patients. To compare the effect of the two lipid emulsions on HIV load in AIDS patients as~     measured by reverse transcriptase (RT) in culture. To determine whether a decrease in HIV~     infectivity is greater in patients given a parenteral feeding regimen containing Liposyn II~     20 percent or Liposyn III 2 percent.~   "
272074|NCT00002274|"~     The objective of this open-label study regimen is to make didanosine (ddI) available to~     patients with AIDS who are clinically deteriorating on zidovudine (AZT) and cannot enter the~     Phase II ddI programs due to protocol exclusion or geographic location.~   "
272075|NCT00002273|"~     To attempt to demonstrate the efficacy of ganciclovir (DHPG) treatment of cytomegalovirus~     (CMV) colitis in AIDS patients by evaluating both clinical and virologic parameters. To~     determine acceptability and the safety profile of a 2-week course of intravenous (IV) DHPG~     therapy.~   "
272076|NCT00002272|"~     To evaluate the safety and efficacy of intermittent intravenous (IV) foscarnet in the~     treatment of acyclovir-resistant herpes simplex virus (HSV) infections in AIDS patients and~     other immunocompromised patients. To evaluate the necessity, efficacy, and safety of IV~     maintenance foscarnet therapy in preventing recurrent disease. To confirm the~     pharmacokinetics of intermittent induction and maintenance IV regimens.~   "
272077|NCT00002271|"~     To characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine~     (FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and~     to assess the safety and tolerance of the single oral doses of FLT.~   "
272078|NCT00002270|"~     To study the effectiveness of alpha interferon (IFN-A2b) and zidovudine (AZT) in treating~     progressive multifocal leukoencephalopathy (PML) as a complication of HIV-1 infection.~   "
272079|NCT00002269|"~     To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine~     (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count~     between 100 and 300 cells/mm3.~   "
272080|NCT00002268|"~     To determine the safety, tolerance, and potential in vivo antiviral effects of five dosage~     levels and a dose to be determined of human anti-cytomegalovirus (CMV) monoclonal antibody~     (SDZ MSL-109; formerly SDZ 89-109) when administered once every 2 weeks for a total of 12~     doses to patients with either AIDS or eligible AIDS-related complex (ARC) and with culture~     proven evidence of CMV viremia and/or viruria. Sandoglobulin will be employed as a~     comparative control.~   "
272081|NCT00002267|"~     The primary objective of this trial is to assess the safety and the relative benefit of~     rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex~     (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to~     placebo, and to assess if survival is prolonged in patients who receive rifabutin~     prophylaxis.~   "
272082|NCT00002266|"~     To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times~     per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or~     AIDS related complex (ARC) patients.~   "
272083|NCT00002265|"~     To demonstrate that zalcitabine (dideoxycytidine; ddC) monotherapy is safe and tolerable in~     the treatment of patients with AIDS or advanced AIDS related complex (ARC) who previously~     demonstrated intolerance to zidovudine (AZT) treatment while in Protocol N3300 (NIAID ACTG~     114) or N3492 (NIAID ACTG 119).~      NOTE OF CAUTION FOR CONCOMITANT MEDICATIONS ON STUDY:~      Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim/sulfamethoxazole,~     ganciclovir, intravenous pentamidine, intravenous acyclovir or oral acyclovir or other bone~     marrow or renal toxic drugs may not tolerate concomitant ddC. If these drugs are given~     concomitantly with ddC, patients should have frequent clinical and laboratory assessments, as~     appropriate. Drugs that are nephrotoxic or have the potential to cause peripheral neuropathy~     might be expected to cause increased toxicity when co-administered with ddC. Drugs that could~     cause serious additive toxicity when co-administered with study medication will be allowed~     for treatment of an acute intercurrent illness or opportunistic infection at the discretion~     of the investigator. Their use may be allowed with interruption of study drug for up to 35~     days per episode, for a total of 90 days for the study. If the patient's condition requires~     chronic administration of these medications, the patient will be discontinued from study~     medication and followed.~   "
272084|NCT00002264|"~     To examine the efficacy of cow's milk immune globulin in the treatment of diarrhea due to~     chronic intestinal cryptosporidiosis in patients with AIDS. The secondary end points of the~     study involve functional improvement which will be determined from nutritional and absorption~     studies.~   "
272085|NCT00002263|"~     To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage~     colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in~     HIV-infected children who have developed granulocytopenia as a result of continuous~     intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of~     concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic~     benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated~     infectious complications.~   "
272190|NCT00002157|"~     To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2~     doses. To gain safety and efficacy data from a broader base of patients with HIV-associated~     wasting in order to support Celgene's pivotal placebo-controlled study.~   "
272086|NCT00002262|"~     To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of~     intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated~     dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF~     injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance~     spectroscopy.~   "
272087|NCT00002261|"~     To determine the physiological and immunological responses in healthy HIV seronegative adult~     volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope~     glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will~     include:~        1. The course of physiological responses to vaccination, including (a) lesion development,~          progression, and resolution; (b) physiological changes such as temperature, malaise,~          itching at the site, etc. and (c) any observable AE.~        2. The appearance, identity, quantity, and duration of humoral antibodies against HIV and~          vaccinia virus.~        3. The appearance, identity, quantity, and duration of cell-mediated immunity against HIV~          and vaccinia virus.~        4. The adequacy of a procedure using a special dressing to contain viral shedding from the~          vaccination site.~        5. The safety, humoral and cellular immune responses of a booster injection of the~          recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.~   "
272088|NCT00002260|"~     To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation)~     after single doses in both the fed and fasting states; to assess the effect of food on the~     oral bioavailability of FLT~   "
272089|NCT00002259|"~     To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in~     AIDS-related Kaposi's sarcoma.~   "
272090|NCT00002258|"~     To determine the safety, tolerability and maximum tolerated dose of SDZ ILE 964 administered~     by daily subcutaneous injections in patients infected with human immunodeficiency virus (HIV)~     who have cytopenias (low blood cell counts). To obtain information about the biologic effects~     of SDZ ILE 964 administration in improving blood counts in HIV-infected patients. To obtain~     information about the effects of SDZ ILE-964 administration on both parameters of HIV~     replication and on residual immunologic function.~   "
272091|NCT00002257|"~     To compare the time to progression of CMV retinitis between oral ganciclovir and IV~     ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of~     oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To~     describe the safety and tolerance of oral ganciclovir treatment when given concurrently with~     anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with~     AIDS and CMV retinitis.~   "
272092|NCT00002256|"~     To provide zalcitabine ( ddC ) for patients with AIDS or Advanced ARC in whom zidovudine (~     AZT ) is contraindicated, or who have failed treatment with or are intolerant to AZT and to~     demonstrate that ddC monotherapy is safe, and tolerable in this patient population.~   "
272093|NCT00002255|"~     To evaluate the safety, tolerance, and biological activity of filgrastim (recombinant~     granulocyte colony stimulating factor; G-CSF) given by daily subcutaneous injection prior to~     and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or~     severe ARC. To evaluate the safety, tolerance, and biological activity of recombinant EPO~     given three times weekly by subcutaneous injection concomitantly with G-CSF and prior to and~     concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance~     of three dose levels of AZT given concomitantly with G-CSF and EPO in patients with AIDS or~     severe ARC. To study the effects of G-CSF on neutrophil function and number in patients with~     AIDS or severe ARC. To study the effect of G-CSF alone and in combination with EPO on HIV~     replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia, and~     semiquantitative HIV cocultures.~   "
272094|NCT00002254|"~     To assess the tolerance and toxicity profile of deoxy-3'-fluorothymidine (FLT) after multiple~     oral dosing for 16 weeks. To characterize the steady-state pharmacokinetics of FLT after~     multiple oral doses. To assess the effect of FLT on immunologic and virologic markers of HIV~     infection (CD4+ lymphocyte count, p24 antigen, viremia) in patients with AIDS or AIDS related~     complex (ARC) after multiple oral dosing for 16 weeks.~   "
272095|NCT00002253|"~     The primary objective of this study is to determine the relapse rate in patients with~     AIDS-related diarrhea who were found to be Responders in a previous placebo-controlled,~     double-blind study of Sandostatin (Study #D203 - FDA 102A).~      The secondary objectives include: 1) To evaluate clinical efficacy and safety of open-label~     Sandostatin in patients who were Non-Responders in Study #D203 - FDA 102A; 2) To evaluate~     the efficacy and safety of Sandostatin during prolonged open-label treatment in Responders~     from Study #D03 - FDA 102A.~   "
272096|NCT00002252|"~     To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in~     controlling diarrhea which is a manifestation or complication of documented HIV infection and~     which is refractory (does not respond) to all known treatment classes.~   "
272097|NCT00002251|"~     This study is designed to determine the influence of food on the absorption and relative~     bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed~     and fasting state at steady state plasma levels.~   "
272098|NCT00002250|"~     To test the effectiveness of recombinant human CD4 Immunoglobulin G (CD4-IgG) in the~     treatment of HIV-associated immune thrombocytopenic purpura in patients with all levels of~     HIV infection.~   "
272099|NCT00002249|"~     To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV~     infection.~   "
272100|NCT00002248|"~     PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the~     volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted~     Cryptosporidium enteritis.~      SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in~     this patient population.~   "
272144|NCT00002203|"~     The purpose of this study is to compare the safety and effectiveness of taking lamivudine~     (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV~     combination tablet (Combivir) plus a PI. This study also examines how well patients follow~     the dosing schedules for these drugs.~      Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV~     plus a PI.~   "
272145|NCT00002202|"~     The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used~     with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also~     examines what effect other drugs have on how the body handles 141W94.~   "
272101|NCT00002247|"~     To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a~     single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To~     compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of~     oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To~     describe the efficacy and safety of double dose versus single dose oral ganciclovir in~     patients who have a progression of retinitis while on the originally assigned maintenance~     treatment. To describe the safety, tolerance, and time to progression of retinitis during the~     52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety~     and tolerance of oral ganciclovir maintenance therapy when given concurrently with~     antiretroviral treatment (e.g., zidovudine, ddI, or ddC). To describe survival of people with~     AIDS and CMV retinitis.~   "
272102|NCT00002246|"~     The purpose of this study is to see if adding stavudine (d4T) to anti-HIV drug regimens (with~     or without zidovudine, ZDV) can improve symptoms of AIDS Dementia Complex (ADC, problems~     involving the brain or spinal cord) in HIV-positive patients.~   "
272103|NCT00002245|"~     The purpose of this study is to evaluate the effects of a 3-drug anti-HIV regimen, amprenavir~     (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats~     are metabolized (processed by the body) in HIV-infected patients who have received little or~     no previous anti-HIV drug therapy.~   "
272104|NCT00002244|"~     The purpose of this study is to see if it is safe and effective to give WF10 to adults with~     late-stage HIV disease. WF10 is suspected to help the immune system fight infection and slow~     HIV disease progression.~   "
272105|NCT00002243|"~     The purpose of this study is to test the safety and effectiveness of a new non-nucleoside~     reverse transcriptase inhibitor (NNRTI), (+)-calanolide A, in HIV-positive patients who have~     never received anti-HIV treatment.~   "
272106|NCT00002241|"~     The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus~     stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV~     in the blood.~   "
272107|NCT00002240|"~     The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This~     drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The~     effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a~     protease inhibitor that is already commonly prescribed.~   "
272108|NCT00002239|"~     The purpose of this study is to see if it is safe and effective to give T-20, a new type of~     anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are~     abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses~     of T-20 are tested.~   "
272109|NCT00002238|"~     To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS~     related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.~   "
272110|NCT00002237|"~     The purpose of this study is to determine the highest amount of peldesine that is safe. This~     study will also see if this amount of peldesine is effective in lowering HIV levels in the~     blood.~   "
272111|NCT00002236|"~     The purpose of this study is to see whether it is better to take delavirdine (DLV) plus~     indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.~   "
272112|NCT00002235|"~     Indinavir is usually taken three times a day. The purpose of this study is to see if it is~     safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a~     day) and efavirenz (taken once a day).~   "
272113|NCT00002234|"~     The purpose of this study is to see if it is safe and effective to give HIV-infected patients~     a new combination of anti-HIV drugs taken once daily.~   "
272114|NCT00002233|"~     The purpose of this study is to see if it is safe to give a combination of four anti-HIV~     drugs to patients recently infected with HIV who have never received anti-HIV treatment. The~     effects of this combination of drugs on the immune system and the level of HIV in the body~     are studied also. The four-drug combination includes lamivudine, abacavir, amprenavir, and~     indinavir.~   "
272115|NCT00002232|"~     The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV~     vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV~     injected into the muscle to the effects of the drug when injected into the skin.~   "
272116|NCT00002231|"~     The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to~     HIV-negative volunteers. This study will also look at how this vaccine affects the immune~     system of these volunteers.~   "
272117|NCT00002230|"~     To determine the virologic benefits associated with the addition of hydroxyurea (HU) to~     combination drug therapy with didanosine (ddI), stavudine (d4T), and efavirenz (DMP) in~     HIV-infected patients. To assess the safety and tolerance of this regimen, with or without~     HU.~   "
272118|NCT00002229|"~     The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft~     gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.~   "
272119|NCT00002228|"~     The purpose of this study is to see if it is safe and effective to give T-20 to HIV-positive~     adults. T-20 is an anti-HIV drug.~   "
272120|NCT00002227|"~     The purpose of this study is to see if it is safe and effective to give efavirenz plus~     stavudine plus lamivudine to patients who have never taken anti-HIV drugs.~   "
272121|NCT00002226|"~     The purpose of this study is to see if it is safe and effective to give SU5416 to~     HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth~     of KS tumors.~   "
272122|NCT00002225|"~     The purpose of this study is to see if it is safe and effective to give efavirenz plus~     stavudine plus didanosine to HIV-infected patients who have never received anti-HIV~     treatment.~   "
272123|NCT00002224|"~     Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a~     new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and~     hopefully will prevent stomach upset. The purpose of this study is to compare the~     effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with~     stavudine (d4T) plus nelfinavir (NLF).~   "
272124|NCT00002223|"~     The purpose of this study is to determine how many HIV-infected patients continue taking~     ritonavir/indinavir combination after having taken indinavir three times a day as part of~     their anti-HIV drug therapy. This study also examines the safety and effectiveness of the~     ritonavir/indinavir combination.~   "
272126|NCT00002221|"~     The purpose of this study is to see if it is safe and effective to use gene therapy to treat~     non-Hodgkin's lymphoma (NHL) in HIV-positive patients.~      Stem cell transplantation is a procedure used to treat NHL. Stem cells are very immature~     cells that develop to create all of the different types of blood cells. In this study, some~     of your stem cells will be treated with gene therapy, meaning the cells are treated with a~     virus that does not cause disease. Some cells will receive a virus that contains ribozymes,~     enzymes that may help fight HIV. Other cells will be treated with a virus that does not~     contain ribozymes to see how the virus works alone. Some cells will not be treated at all.~     Doctors would like to see whether giving patients stem cells with ribozymes can treat NHL and~     stop HIV from growing at the same time.~   "
272127|NCT00002220|"~     The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz~     plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients~     who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of~     patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks~     of treatment.~   "
272128|NCT00002219|"~     The purpose of this study is to see if it is safe and effective to give adefovir (a new~     anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other~     anti-HIV medications.~   "
272129|NCT00002218|"~     To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To~     determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess~     the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination~     therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral~     agents.~   "
272130|NCT00002217|"~     The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94~     in patients who previously have used anti-HIV drugs.~   "
272131|NCT00002216|"~     The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients~     who have never received anti-HIV treatment.~   "
272132|NCT00002215|"~     To compare the proportion of patients whose plasma HIV-1 RNA level falls and remains below~     the limit of quantification by the Roche Amplicor Monitor (400 copies/ml)[AS PER AMENDMENT~     8/4/98: 50 copies/ml] between weeks 0 and 24. To determine the short-term safety and~     tolerability of MKC-442 plus nelfinavir (Viracept) plus dual nucleoside analogs. To determine~     the time to viral failure and time to tolerability failure through Week 48 of therapy.~   "
272133|NCT00002214|"~     To assess the toxicity profile and determine the maximum tolerated dose (MTD), if possible,~     of S-1153 administered orally 3 times daily for 14 days. To investigate the clinical~     pharmacokinetic parameters for S-1153. To assess anti-HIV activity associated with S-1153~     administration through evaluation of CD4 and viral load measurements.~   "
272134|NCT00002213|"~     The purpose of this study is to see if it is safe and effective to give 1592U89 plus 141W94~     plus DMP 266 to patients with HIV who have developed resistance to indinavir, ritonavir,~     saquinavir, or nelfinavir after at least 20 weeks of protease inhibitor treatment. This study~     also examines how long this combination therapy is effective before patients develop~     resistance to it.~   "
272135|NCT00002212|"~     The purpose of this study is to see if it is safe and effective to give Targretin capsules to~     patients with AIDS-related Kaposi's sarcoma (KS).~   "
272136|NCT00002211|"~     The purpose of this study is to see if it is safe and effective to give combinations of three~     or four anti-HIV drugs to HIV-infected patients. The drugs used in this study are delavirdine~     (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).~   "
272137|NCT00002210|"~     The purpose of this study is to see if it is safe and effective to give delavirdine mesylate~     (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to HIV-infected~     children and babies. This study also examines how the body processes Rescriptor when taken~     with 2 NRTIs.~   "
272138|NCT00002209|"~     The purpose of this study is to see if it is safe to give multiple doses of CPI-1189 to~     HIV-infected, otherwise healthy, males. The study will also look at how CPI-1189 affects the~     levels of HIV, T cells (cells in the body that help fight infection), and three anti-HIV~     drugs (zidovudine, lamivudine, and indinavir) in the blood.~      Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses of~     memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.~   "
272139|NCT00002208|"~     To demonstrate that the antiviral activity and safety/tolerability of a test regimen of~     indinavir is equivalent to that of a control regimen of indinavir when each is coadministered~     with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease~     inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state~     pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other,~     for both the control and test regimen groups.~   "
272140|NCT00002207|"~     The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a~     day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This~     study also examines the safety of giving ddI with d4T in the short-term.~   "
272141|NCT00002206|"~     The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil~     once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV~     medicine. This study also examines how the body processes adefovir dipivoxil.~   "
272142|NCT00002205|"~     To assess the safety, tolerance, and efficacy of amprenavir (APV) plus abacavir (ABC) in~     patients who have previously failed antiretroviral treatment containing a protease inhibitor~     (PI). To provide open-label, pre-approval access to APV for adults and adolescents with HIV-1~     infection and limited treatment options.~      This study is being conducted to provide open-label APV to patients in danger of HIV disease~     progression, as well as those who may benefit beyond the expected outcomes of current~     anti-retroviral therapies. Despite unapproved status, APV may prove highly efficacious in~     combatting HIV progression and may help those in need, prior to regulatory approval.~   "
272143|NCT00002204|"~     To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus~     (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the~     immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.~   "
272191|NCT00002156|"~     To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an~     additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV)~     retinitis.~   "
272148|NCT00002199|"~     To compare the safety, tolerance, early antiviral activity, and durability of antiviral~     response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir~     (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the~     occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and~     the development of plasma viral genotypic and phenotypic resistance.~   "
272149|NCT00002198|"~     The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain~     alcohol) when they are given together.~   "
272150|NCT00002197|"~     The purpose of this study is to see if it is safe to give 1592U89 to children (aged 6 months~     until 14th birthday) with advanced HIV infection who have few treatment options available.~     The study also examines the effect 1592U89 has on the levels of HIV in the blood.~   "
272151|NCT00002196|"~     The purpose of this study is to see if it is safe and effective to give CI-1012 to~     HIV-infected patients who do not have any symptoms of the disease. This study also examines~     how the body handles CI-1012.~   "
272152|NCT00002195|"~     The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV~     regimen that includes retrovir plus epivir.~   "
272153|NCT00002194|"~     To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin,~     and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.~   "
272154|NCT00002193|"~     The purpose of this study is to see if it is safe and effective to add a new protease~     inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse~     transcriptase inhibitors (NRTIs).~   "
272155|NCT00002192|"~     To determine the antimicrobial activity and tolerability of rifapentine alone and in~     combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC)~     bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite,~     25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of~     azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.~   "
272156|NCT00002191|"~     To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole,~     administered for 28 days, compared to placebo and for 62 days in open-label fashion, in~     treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of~     albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and~     on the relationship between microsporidial counts in stool and stool frequency and volume. To~     correlate microsporidial counts with the clinical course of microsporidiosis.~   "
272157|NCT00002190|"~     To explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus~     lamivudine.~   "
272158|NCT00002189|"~     To determine response rate, median time to tumor progression, qualitative and quantitative~     toxicity and reversibility of toxicity in patients with advanced refractory AIDS-associated~     Kaposi's sarcoma (KS) administered a 3-hour infusion of paclitaxel every 14 days. To evaluate~     the clinical benefit of paclitaxel in this patient population by evaluating self-reported~     responses to the Symptom Distress Scale and by documenting and evaluating any changes in~     their lymphedema, pain and disfiguring facial lesions.~   "
272159|NCT00002188|"~     The purpose of this study is to see if ALRT1057 is safe and effective in treating patients~     with AIDS-related Kaposi's sarcoma (KS).~   "
272160|NCT00002187|"~     The purpose of this study is to compare the safety and effectiveness of two dosage schedules~     for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis~   "
272161|NCT00002186|"~     To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303~     gel in combination with acyclovir, relative to acyclovir alone, for the treatment of~     recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and~     neighboring areas, in patients with AIDS.~   "
272162|NCT00002185|"~     To determine the effect of Viracept in combination with modified antiretroviral therapy on~     the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).~   "
272163|NCT00002184|"~     To evaluate the safety and tolerance of the combination of adefovir dipivoxil at two~     comparative doses and nelfinavir plus saquinavir SGC administered orally (Group 1) vs. the~     combination of adefovir dipivoxil and nelfinavir plus either zidovudine, lamivudine, or~     stavudine (Group 2) vs. the combination of adefovir dipivoxil and saquinavir SGC plus either~     zidovudine, lamivudine, or stavudine (Group 3) in HIV-infected patients with prior nucleoside~     reverse transcriptase inhibitor therapy but no prior exposure to protease inhibitors who have~     CD4 cell counts >= 100 cells/mm3 and an HIV-1 RNA baseline copy number >= 5000 copies/ml. To~     determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of~     detection (<500 copies/ml) at 20 weeks of study therapy and the average reduction in HIV-1~     RNA from baseline through study week 20. To evaluate the durability of the antiviral response~     through 48 weeks of study in patients who continue on study therapy after week 24.~   "
272164|NCT00002183|"~     To assess the safety and tolerance of multiple oral doses of 141W94 alone, in combination~     with 1592U89, and in combination with Retrovir and Epivir, administered to patients with HIV~     infection as measured by the development of clinical adverse experiences and laboratory test~     abnormalities. To determine the steady-state pharmacokinetics of 141W94 alone and in~     combination with 1592U89 after multiple oral dosing. To obtain preliminary evidence of~     antiretroviral activity of 141W94 alone and in combination with 1592U89, the antiretroviral~     effect of combined Retrovir/Epivir and the antiretroviral effect of 141W94 when added to~     Retrovir/Epivir or to 1592U89/Retrovir/Epivir.~   "
272165|NCT00002182|"~     The purpose of this study is to see if megestrol acetate is safe and effective in treating~     HIV-infected children with failure to thrive (FTT).~   "
272166|NCT00002181|"~     The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in~     treating herpes simplex in patients with AIDS who do not respond to acyclovir.~   "
272167|NCT00002180|"~     The purpose of this study is to see if it is safe and effective to give PMPA to HIV-infected~     patients. This study also examines how the body handles PMPA.~   "
272192|NCT00002155|"~     To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine~     (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan )~     plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.~   "
272218|NCT00002129|"~     To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected~     patients with CD4 count > 300 cells/mm3.~   "
272168|NCT00002179|"~     To evaluate the ability of the combination of indinavir, zidovudine, and lamivudine to~     suppress HIV-1 infection as measured by: (1) the maintenance of HIV-1 serum viral RNA below~     the limit of detection of the most sensitive validated assay (ultradirect assay) and (2)~     absence of evidence of infectious virus in lymph node, cerebrospinal fluid (CSF), peripheral~     mononuclear cells (PBMCs), and semen.~      It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will~     result in:~        1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in~          50% of patients who have undetectable viral RNA by the most sensitive validated assay~          available (ultradirect assay) for at least 48 weeks.~        2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to~          below the limit of detection of the ultradirect assay for at least 48 weeks in at least~          25% of patients.~        3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the~          limit of detection of the standard Amplicor assay (i.e., negative) in at least 90% of~          patients by Week 16.~        4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by~          maintenance of serum viral RNA to below the limit of detection of the ultradirect assay~          for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in~          patients who have maintained this level of suppression for at least 120 weeks on~          therapy.~   "
272169|NCT00002178|"~     To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of~     detection (< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute~     change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study~     treatment. To collect safety data on the treatment regimens. To determine the percentage of~     patients without SQV soft gel capsules resistance-associated mutations at week 24.~   "
272170|NCT00002177|"~     To assess the magnitude and duration of the antiviral activity in plasma and the incidence~     and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety~     and tolerability of this combination therapy and the magnitude and duration of the effect of~     these drugs over CD4 cell counts.~   "
272171|NCT00002176|"~     To assess the magnitude and duration of the antiviral activity in plasma and the incidence~     and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety~     and tolerability of this combination therapy and the magnitude and duration of the effect of~     this therapy over CD4 cell counts.~   "
272172|NCT00002175|"~     To evaluate the efficacy of dinitrochlorobenzene (DNCB) in patients with early HIV infection~     by monitoring immunologic parameters and serum HIV RNA. To facilitate the understanding of~     possible alterations in the immunological status of the HIV+ patient cohort.~   "
272173|NCT00002174|"~     To determine if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha,~     MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients and~     alters viral load.~   "
272174|NCT00002173|"~     To provide an alternative therapy to HIV-infected patients for whom there is no comparable or~     satisfactory alternative drug or therapy available.~   "
272175|NCT00002172|"~     To provide product through an expanded access program to HIV-infected patients with CD4~     counts less than 300 cells/ml.~   "
272176|NCT00002171|"~     The purpose of this study is to see if it is safe and effective to give Viracept plus~     stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count <= 400~     cells/mm3. This study also examines how the body handles Viracept when given with d4T and~     3TC.~   "
272177|NCT00002170|"~     The purpose of this study is to see if it is safe and effective to give Viracept to AIDS~     patients who are being treated for MAC.~   "
272178|NCT00002169|"~     The purpose of this study is to see if it is safe and effective to give Viracept to AIDS~     patients who are already being treated for cytomegalovirus (CMV) retinitis.~   "
272179|NCT00002168|"~     The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug~     combinations when given to HIV-infected patients who have never been treated with anti-HIV~     drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other~     combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.~   "
272180|NCT00002167|"~     To determine the objective tumor response and remission rate of AIDS-related Kaposi's~     sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by~     photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity~     safety profile of SnET2-PDT.~   "
272181|NCT00002166|"~     To provide access to Viramune and to evaluate the tolerance and safety of Viramune in~     patients with progressive, symptomatic HIV disease who failed or are intolerant to currently~     approved treatment for HIV-1 infection and who are unable to participate in another Viramune~     controlled clinical trial and have a compelling need for anti-HIV treatment.~   "
272182|NCT00002165|"~     To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients who~     are unable to take the three commercially available protease inhibitors (because of failure,~     intolerance, or contraindication) and who have a CD4 cell count of <= 50. To obtain~     additional information on the safety profile of nelfinavir mesylate (Viracept).~      (PER AMENDMENT 1/8/97: People now qualify for the Viracept Program if they are unable to take~     indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)~   "
272183|NCT00002164|"~     To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation~     administered to HIV infected or exposed children and infants (0 to 13 years of age). An~     evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard~     tablet formulation in older children (7 to 13 years of age) will also be conducted.~   "
272184|NCT00002163|"~     To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS~     dementia complex and to assess the safety and tolerance of the treatment regimens.~   "
272185|NCT00002162|"~     To evaluate the antiviral activity and safety of two formulations of saquinavir in~     combination with licensed nucleoside antiretroviral drugs.~   "
272186|NCT00002161|"~     To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA~     ) in combination with standard antiretroviral therapy for 48 weeks.~   "
272187|NCT00002160|"~     To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer~     and AIDS patients.~   "
272195|NCT00002152|"~     The purpose of this study is to see if it is safe and effective to give WF 10 (TCDO) to~     patients with advanced HIV disease who cannot or will not take zidovudine, didanosine,~     zalcitabine, or stavudine. This study also examines how TCDO affects the levels of HIV in the~     body. TCDO is a solution delivered through a vein.~   "
272196|NCT00002151|"~     To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and~     in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic~     HIV infection. To examine the demographic effects on population pharmacokinetics and~     pharmacodynamics of MDL 28,574A alone and in combination with AZT.~   "
272197|NCT00002150|"~     To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and~     in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic~     HIV infection. To examine the demographic effects on population pharmacokinetics and~     pharmacodynamics of MDL 28,574A alone and in combination with AZT.~   "
272198|NCT00002149|"~     To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of~     pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin~     ) in reducing symptoms and recurrence of acute HIV-related sinusitis.~      Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with~     potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of~     life-threatening sepsis, and progress to central nervous system involvement. Symptoms of~     sinusitis in HIV patients are often refractory to aggressive Western medical management, and~     antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and~     herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic~     therapy.~   "
272199|NCT00002148|"~     To assess the tolerability and safety of OPC-14117. To evaluate effects of OPC-14117 on~     cognitive function, quality of life, and activities of daily living.~   "
272200|NCT00002147|"~     To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's~     sarcoma patients who have no remaining treatment options other than DOX-SL or patients who~     have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is~     medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with~     Kaposi's sarcoma who have previously received systemic chemotherapy with or without an~     anthracycline.~   "
272201|NCT00002146|"~     To determine whether acute ionized hypomagnesemia and hypocalcemia immediately following~     foscarnet infusions can be lessened or eliminated by prior infusion of magnesium sulfate. To~     determine whether reductions in ionized magnesium, ionized calcium, and parathyroid hormone~     levels following foscarnet infusions are lessened by preinfusion of magnesium sulfate. To~     evaluate the safety of intravenous magnesium sulfate prior to foscarnet infusion by~     monitoring blood pressure, heart rate, and heart rhythm. To characterize the effect of~     magnesium sulfate on foscarnet blood levels and urinary excretion of calcium, magnesium,~     phosphate, and foscarnet.~   "
272202|NCT00002145|"~     PRIMARY: To compare the frequency of and time to relapse of Cytomegalovirus (CMV)~     gastrointestinal disease following foscarnet induction therapy only versus induction plus~     maintenance therapy.~      SECONDARY: To determine frequency of and time to recurrence of gastrointestinal symptoms,~     response rate of pathological lesions, and incidence of nongastrointestinal CMV disease in~     this patient population.~   "
272203|NCT00002144|"~     PRIMARY: To evaluate the clinical activity of foscarnet cream on the index lesion of~     mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients previously~     unresponsive to acyclovir treatment.~      SECONDARY: To evaluate the clinical activity and virologic activity of foscarnet cream on all~     treated lesions in this patient population. To evaluate the local tolerance and side effects~     of treatment with foscarnet cream in this patient population.~   "
272204|NCT00002143|"~     To determine the efficacy of acitretin in the treatment of psoriasis in HIV/AIDS patients.~      Etretinate, a retinoid, has proven successful in the treatment of HIV-infected patients with~     psoriasis, but it has an elimination half-life of 100 days. Acitretin, a metabolite of~     etretinate, has a much shorter half-life of 2 to 3 days. Acitretin has proven effective in~     treating psoriasis in patients without HIV infection by reducing skin involvement and~     clearing of the condition, but it has not been thoroughly evaluated in HIV-infected patients.~   "
272205|NCT00002142|"~     To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with~     relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in~     this patient population. To evaluate the impact of cidofovir therapy on visual acuity.~   "
272206|NCT00002141|"~     To assess the safety of single oral doses of 1592U89 (abacavir succinate, ABC) administered~     to HIV-positive individuals. To determine the pharmacokinetics of 1592U89 after single oral~     doses. To determine the effects of food on the bioavailability of 1592U89.~   "
272207|NCT00002140|"~     To evaluate the efficacy and safety of two different doses of azithromycin in combination~     with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC)~     infection, and to determine whether an azithromycin-containing regimen is at least as safe~     and effective as the same regimen containing clarithromycin..~   "
272208|NCT00002139|"~     To compare the uptake of azithromycin in white cells relative to plasma concentrations in~     HIV-infected patients.~   "
272209|NCT00002138|"~     To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152)~     and to establish the MTD at each of the different dosing schedules.~   "
272210|NCT00002137|"~     To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152)~     and to establish the MTD at each of the different dosing schedules.~   "
272211|NCT00002136|"~     To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152)~     and to establish the MTD at each of the different dosing schedules.~   "
272212|NCT00002135|"~     To provide oral ganciclovir to patients who require maintenance for control of~     cytomegalovirus (CMV) retinitis, but who lack patent permanent central venous access for~     long-term administration of intravenous drugs.~   "
272213|NCT00002134|"~     To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV)~     disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal~     ganciclovir implant. To compare safety and tolerance, time to progression, quality of life,~     and survival among patients treated with an intravitreal ganciclovir implant, with and~     without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.~   "
272221|NCT00002126|"~     To determine, in HIV-infected patients, the efficacy of filgrastim ( recombinant-methionyl~     human granulocyte-colony stimulating factor; G-CSF ) in preventing grade 4 neutropenia, i.e.,~     absolute neutrophil count (ANC) < 500 cells/mm3.~   "
272222|NCT00002125|"~     To assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium~     (Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate~     the timing and volume of oral fluid hydration required to establish a diuresis before and~     during intravenous Foscavir therapy. To assess the general tolerance of two hydration~     regimens by the adverse event profile associated with each.~   "
272223|NCT00002124|"~     PART I: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of three fixed~     doses of delavirdine mesylate (DLV) in combination with zidovudine (AZT) versus AZT alone in~     HIV-positive patients.~      PART II: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of ZDV plus 3TC~     with or without DLV versus ZDV plus DLV in HIV-positive patients.~   "
272224|NCT00002123|"~     To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate~     (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.~   "
272225|NCT00002122|"~     PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for~     the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected~     patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of~     deep fungal infections in this patient population.~      SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections,~     cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing~     regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients~     treated with daily versus weekly fluconazole. To compare survival and outcomes of primary~     endpoints in the treatment arms.~   "
272226|NCT00002121|"~     To perform preliminary clinical testing of diethylhomospermine (DEHSPM), a polyamine~     analogue, for refractory AIDS-related diarrhea.~      Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory~     AIDS-related diarrhea.~   "
272227|NCT00002120|"~     To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with~     leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS~     and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic~     parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS~     and moderately severe PCP.~   "
272228|NCT00002119|"~     To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution~     administered to patients with HIV infection. To evaluate the potential anti-HIV activity of~     TCDO.~   "
272229|NCT00002118|"~     To allow, on a compassionate use basis, zalcitabine (ddC) for pediatric patients with~     symptomatic HIV disease who have failed treatment or who are intolerant to zidovudine (AZT),~     or who have completed other ddC protocols, or who are ineligible for ongoing clinical trials.~   "
272230|NCT00002117|"~     To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT~     ) schedule for use in combination therapy in patients with HIV infection.~   "
272231|NCT00002116|"~     To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory~     mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical~     HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes~     simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC~     therapy on herpes simplex virus shedding from refractory lesions.~   "
272232|NCT00002115|"~     To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir )~     when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients~     with advanced HIV disease.~   "
272233|NCT00002114|"~     To compare the efficacy and safety of orally administered Procysteine with placebo in~     HIV-infected patients who are receiving 1 of the following: (1) zidovudine (AZT) alone; (2)~     didanosine (ddI) alone; (3) AZT plus ddI; or (4) AZT plus zalcitabine (ddC).~   "
272234|NCT00002113|"~     To evaluate and estimate the safety and efficacy of the combination of fluconazole and~     flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS.~      Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not~     been associated with hematologic suppression and does not produce renal impairment that can~     result in higher serum flucytosine levels, this combination may be better tolerated than is~     amphotericin B plus flucytosine.~   "
272235|NCT00002112|"~     To compare the efficacy, safety, and toleration of fluconazole as a single daily oral~     suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the~     treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.~   "
272236|NCT00002111|"~     To investigate the toxicity, antiviral activity, and pharmacokinetics in HIV-infected~     patients receiving 16 weeks of oral saquinavir mesylate ( Ro 31-8959 ) at one of two doses.~   "
272237|NCT00002110|"~     To determine the safety and tolerance of low-dose versus high-dose cysteamine administered~     concurrently with zidovudine (AZT). To determine the pharmacokinetics and effects on immune~     function and viral load in patients receiving these drug regimens.~   "
272238|NCT00002109|"~     To confirm results from a previous study in which the combination of thymopentin plus~     zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected~     asymptomatic patients. To evaluate the efficacy and safety of thymopentin in HIV-infected~     asymptomatic patients receiving either monotherapy with AZT, didanosine ( ddI ), or stavudine~     ( d4T ), or combination antiretroviral therapy with AZT / ddI or AZT / zalcitabine ( ddC ).~   "
272239|NCT00002108|"~     To make lamivudine (3TC) available to patients with progressive, symptomatic HIV disease who~     cannot participate in a controlled clinical trial and who are refractory or unable to~     tolerate other therapies. To collect data pertaining to the safety of 3TC at two dose levels.~     To evaluate the effect of 3TC on markers of hepatitis B in co-infected patients at five to~     ten selected sites.~   "
272260|NCT00002087|"~     To investigate the safety and tolerance of an increasing number of infusions per week of~     alvircept sudotox ( sCD4-PE40; soluble CD4-Pseudomonas exotoxin ) at a fixed dose when~     administered to HIV-1-infected individuals. To investigate the effect of sCD4-PE40 on the~     following parameters: T lymphocyte subsets, plasma HIV RNA and cellular HIV proviral DNA in~     PBMC and CD4 cells, p24 levels, serum beta-2 microglobulin, and neopterin levels.~   "
272240|NCT00002107|"~     To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin;~     Proleukin) administered subcutaneously in HIV-seropositive patients. To identify a tolerable~     subcutaneous regimen that will replicate the immunologic improvement demonstrated in the~     outpatient polyethylene glycolated IL-2 and high-dose continuous infusion IL-2 studies. To~     evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously~     administered Proleukin in this patient population.~   "
272241|NCT00002106|"~     To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected~     patients with CD4 counts of 400-700 cells/mm3.~   "
272242|NCT00002105|"~     To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the~     treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the~     established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of~     DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.~   "
272243|NCT00002104|"~     To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or~     without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam,~     and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To~     demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis~     lesions, and immune responses.~   "
272244|NCT00002103|"~     To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in~     European patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have~     demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or~     parenteral pentamidine).~   "
272245|NCT00002102|"~     To provide trimetrexate glucuronate to immunosuppressed patients with Pneumocystis carinii~     pneumonia (PCP) for whom this investigational compound could provide significant medical~     benefit.~   "
272246|NCT00002101|"~     To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two~     different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients~     with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks~     post-randomization. To assess survival and comparative tolerability among the three treatment~     regimens.~   "
272247|NCT00002100|"~     To assess the safety and tolerance of curdlan sulfate, as well as its anti-HIV activity, in~     HIV-infected patients with CD4 T-lymphocytes less than 500 cells/mm3, using first single~     doses and then, after FDA review, daily doses for 7 days.~   "
272248|NCT00002099|"~     To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI)~     in comparison with ddI alone. To determine whether the combination of lentinan and ddI~     produces a significant immunorestorative effect within the study observation period (6-12~     months) as measured by an increase in one or more of the following: neutrophil count and~     activity, T-cell subsets, and a decrease in p24 antigen.~   "
272249|NCT00002098|"~     To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI)~     compared with ddI alone. To determine whether the combination of lentinan and ddI produces a~     significant immunorestorative effect within the study observation period (6-12 months) as~     measured by an increase in one or more of the following: neutrophil count and activity,~     T-cell subsets, and a decrease in p24 antigen.~   "
272250|NCT00002097|"~     To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous~     nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and~     clinical pharmacology of intravenous nystatin.~   "
272251|NCT00002096|"~     To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and~     oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine~     whether concurrent administration of probenecid affects the pharmacokinetics of oral~     ganciclovir. To obtain data on the short-term safety of oral ganciclovir administered~     concurrently with AZT, ddI, or probenecid in HIV-positive patients.~   "
272252|NCT00002095|"~     To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus~     (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with~     HIV infection and CD4 lymphocyte counts <= 100 cells/mm3. To evaluate the efficacy of this~     drug in reducing morbidity associated with coinfection by both CMV and HIV.~   "
272253|NCT00002094|"~     To determine the time course of development of resistance to atevirdine mesylate ( U-87201E )~     in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine~     the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to~     U-87201E. To determine the genotype and phenotype effects of treatment with a~     nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in~     vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in~     the presence of U-87201E will generate the resistant mutants that may subsequently emerge in~     the patients.~   "
272254|NCT00002093|"~     To compare the toxicity profiles (severity and time to onset from initiation of therapy)~     between daunorubicin (liposomal) and combination chemotherapy with~     doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with~     antiretroviral therapy. To compare the duration of responses, response rates, and times to~     response.~   "
272255|NCT00002092|"~     To determine the change in CD4 count after 4 and 8 weeks in HIV-infected patients treated~     with cimetidine compared to placebo. To observe time-associated trends at weeks 4, 8, 12, and~     16 in the change of CD4 counts for patients taking cimetidine for the full 16 weeks. To~     establish a safety record for cimetidine use in HIV-positive patients.~   "
272256|NCT00002091|"~     PRIMARY: To determine whether pentoxifylline changes the self-reported measures of quality of~     life status, using measures of scores from double-blinded drug withdrawal and drug restart~     periods.~      SECONDARY: To measure the changes in monthly CD4 counts, fasting serum triglyceride levels,~     and weight; to assess the safety of pentoxifylline in HIV-infected persons.~   "
272257|NCT00002090|"~     To evaluate the efficacy and safety of two doses of azithromycin given chronically for the~     treatment of Mycobacterium avium bacteremia in AIDS patients.~   "
272258|NCT00002089|"~     To evaluate the efficacy and safety of azithromycin given chronically for the treatment of~     Mycobacterium avium (MAC) bacteremia in patients failing or intolerant of current available~     MAC therapy.~   "
272259|NCT00002088|"~     To assess the efficacy of Saccharomyces boulardii (a nonpathogenic yeast) in producing a~     significant reduction in diarrheal symptoms in HIV-infected patients with chronic diarrhea.~   "
272261|NCT00002086|"~     Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1~     (Retrovir/HIVID/Wellferon) can produce complete responses (i.e., CD4 counts return to >= 800~     cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To~     determine the antiviral effect of the combination therapies as evidenced by measures of~     quantitative viral load performed at select study centers only.~      Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in~     maintaining or increasing CD4 counts and preventing disease progression as evidenced by the~     development of an AIDS-defining indicator disease. To determine the effect of these regimens~     on secondary measures of clinical status (e.g., performance score, weight change, and~     secondary infections) and on measures of virologic activity such as serum p24 antigen. To~     assess the safety and tolerance of these regimens.~   "
272262|NCT00002085|"~     To evaluate the efficacy and safety of azithromycin given chronically for the treatment of~     serious nontuberculous mycobacterial infection in patients failing or intolerant of other~     available therapy.~   "
272263|NCT00002084|"~     To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared~     to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with~     CD4 counts = or > 100 cells/mm3.~   "
272264|NCT00002083|"~     To compare the effects of intranasal peptide T and placebo in the treatment of painful~     peripheral neuropathy associated with human immunodeficiency virus (HIV) infection.~   "
272265|NCT00002082|"~     To evaluate the safety and efficacy of azithromycin in the treatment of intestinal~     cryptosporidial infection in AIDS patients.~   "
272266|NCT00002081|"~     To provide zalcitabine ( dideoxycytidine; ddC ) for use with zidovudine ( AZT ) in patients~     with advanced HIV infection. To observe serious toxicities in this population.~   "
272267|NCT00002080|"~     Primary: To provide rifabutin to HIV positive patients in an attempt to prevent or delay~     Mycobacterium avium Complex (MAC) infection by a daily dose of rifabutin.~      Secondary: To further characterize the safety of rifabutin monotherapy in preventing or~     delaying MAC bacteremia in HIV positive patients with CD4 counts = or < 200.~   "
272268|NCT00002079|"~     To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in~     combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells/mm3. To~     determine the safety of escalating doses of SC-48334 when administered in combination with~     any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4+~     cells/mm3, and to assess the pharmacokinetics of the two drugs, given separately and in~     combination.~   "
272269|NCT00002078|"~     To determine the safety and tolerance of subcutaneous injections of natural interferon alpha~     (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these~     individuals.~   "
272270|NCT00002077|"~     To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial~     treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS~     patients. Lack of satisfactory response will allow increase of dose. Both newly diagnosed and~     relapsed patients are eligible.~   "
272271|NCT00002076|"~     To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal~     meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.~   "
272272|NCT00002075|"~     To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in~     combination with flucytosine, as treatment for acute cryptococcal meningitis.~   "
272273|NCT00002074|"~     To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance~     treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.~   "
272274|NCT00002073|"~     To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS~     patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.~     Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.~   "
272275|NCT00002072|"~     To determine the safety and efficacy of erythropoietin (r-HUEPO) administered to AIDS~     patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.~   "
272276|NCT00002071|"~     To determine the safety and efficacy of erythropoietin administered to AIDS patients with~     anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.~   "
272277|NCT00002070|"~     To determine whether co-administration of sargramostim (granulocyte-macrophage~     colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously~     intolerant because of neutropenia defined as an absolute neutrophil count less than 500~     cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable~     outcome as defined by a delayed time to progression of retinitis; to confirm the safety and~     co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV~     p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving~     ganciclovir with or without GM-CSF.~   "
272278|NCT00002069|"~     To determine if ditiocarb sodium (sodium diethyldithiocarbamate; DTC) restores immune and~     host defense function; if DTC ameliorates the AIDS related complex (ARC) symptoms in patients~     with AIDS and ARC; if DTC prevents progression from ARC to AIDS or progression of AIDS; and~     if DTC prolongs survival in AIDS.~   "
272279|NCT00002068|"~     To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in~     combination with flucytosine, as treatment for acute cryptococcal meningitis.~   "
272280|NCT00002067|"~     To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia,~     calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS. To~     determine whether megestrol acetate relative to placebo improves the perception of well-being~     among AIDS patients with cachexia. To evaluate megestrol acetate's effect on immune function~     via skin test reactivity, T4/T8 ratio, and total lymphocytes.~   "
272281|NCT00002066|"~     Examine the ability of thymopentin (Timunox) to:~      Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter~     the clinical findings in patients infected with HIV who do not yet have AIDS.~   "
272282|NCT00002065|"~     To assess the safety and efficacy of depot disulfiram as a new treatment for AIDS and AIDS~     related complex.~   "
272283|NCT00002064|"~     To compare pyrimethamine and intravenous (IV) clindamycin vs. pyrimethamine and sulfonamides~     in the treatment of AIDS patients with central nervous system (CNS) Toxoplasma gondii.~   "
272284|NCT00002063|"~     Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of~     time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia,~     and malignancies) or death. Initial drug assignment will be changed to open-label AZT for~     patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200~     cells/mm3, but analysis will be based on initial treatment assignment. To determine the~     immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte~     concentration of at least 25 percent from baseline assessment. To determine the antiviral~     effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine~     the effect of AZT compared to placebo on the immune status of HIV-infected patients by~     comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT~     compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin,~     gastrointestinal system, and central nervous system. To describe the natural history of AIDS~     related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration~     and the Walter Reed staging system.~   "
272285|NCT00002062|"~     This protocol provides for the availability of spiramycin under compassionate-use conditions~     for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised~     immune system, thus deriving additional information regarding its safety and efficacy~     profile.~   "
272286|NCT00002061|"~     The objective of this Phase III, randomized, double-blind, placebo-controlled study in~     patients with immunologic deficiency is to determine the effect of isoprinosine in producing~     an immuno-restorative response within the study observation period (including the 2-month~     period following cessation of the 28 days of treatment), measured by one or more of the~     following immunologic parameters:~        -  Increase in natural killer (NK) cell activity.~        -  Increase in total T-cells (OKT-11).~        -  Increases in absolute number and percentages of T-helper cells (OKT-4).~   "
272287|NCT00002060|"~     The objective is to determine the effect of Isoprinosine (inosine pranobex) in homosexual~     male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to~     determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser~     opportunistic infections and/or other conditions associated with ARC.~   "
272288|NCT00002059|"~     The objective of this double-blind placebo-controlled study is to evaluate the effect of~     Isoprinosine in a group of homogenous male volunteers who present with immunologic defects~     relative to:~        -  Comparison of total helper and suppressor T-cell number between the groups.~        -  Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative~          response and natural killer (NK) cell activity between the groups.~        -  Determination of the clinical course of the volunteers after discontinuance of~          Isoprinosine.~   "
272289|NCT00002058|"~     This study will examine the effectiveness of clofazimine in the prophylaxis of Mycobacterium~     avium complex infection in HIV infected individuals who are at risk to develop this~     untreatable opportunistic disease. In the absence of truly effective antiretroviral therapy,~     a potential mode of treatment of patients with HIV infection is to prevent the development of~     the life-threatening opportunistic infections. Current studies demonstrate a possible~     efficacy of clofazimine in the prophylaxis against Pneumocystis carinii pneumonia (PCP), the~     most common AIDS-defining opportunistic infection. Future studies will examine the potential~     for prophylaxis against the other opportunistic infections. This proposal hopes to define the~     role of prophylactic clofazimine in preventing the currently untreatable Mycobacterium avium~     complex infection. AMENDED: To include prophylaxis for Asymptomatic and ARC.~   "
272290|NCT00002057|"~     To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the~     prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III~     or IV, CDC classification).~   "
272291|NCT00002056|"~     This is a randomized double-blinded controlled study comparing aerosolized pentamidine with~     trimethoprim plus sulfamethoxazole (TMP / PurposeX). The latter drug will be administered~     intravenously for at least 5 days, then changed to oral administration if warranted by the~     patient's clinical condition.~   "
272292|NCT00002055|"~     To evaluate and compare the safety, tolerability, and effectiveness of long-term biweekly~     administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in~     patients who have had multiple episodes of AIDS associated Pneumocystis carinii pneumonia~     (PCP).~   "
272293|NCT00002054|"~     To evaluate the safety, tolerability, and description of time to Pneumocystis carinii~     pneumonia (PCP) for long-term biweekly administration of 1 of 2 doses of aerosol pentamidine~     when used as a prophylactic agent in patients who have had one episode of AIDS-associated~     PCP.~   "
272294|NCT00002053|"~     To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of~     aerosol pentamidine versus placebo when used as a prophylactic agent in patients who have~     recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).~   "
272295|NCT00002052|"~     To compare the effectiveness of standard treatment with parenteral ampicillin and oral~     amoxicillin compared to initial daily therapy with ceftriaxone followed by 3 times weekly~     suppressive treatment for salmonella infections in AIDS patients.~   "
272296|NCT00002051|"~     Examine the ability of thymopentin (Timunox) to:~      Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter~     the clinical findings in patients infected with HIV who do not yet have AIDS.~   "
272297|NCT00002050|"~     Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus~     isolation. Examine the ability of thymopentin to stimulate the immune system and alter the~     clinical findings in patients infected with HIV who do not yet have AIDS.~   "
272298|NCT00002049|"~     Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus~     isolation. Examine the ability of thymopentin to stimulate the immune system and alter the~     clinical findings of patients infected with HIV who do not yet have AIDS.~   "
272299|NCT00002048|"~     To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in~     HIV-infected adult patients without clinical manifestations of disease. To assess the~     efficacy of AZT therapy in the treatment of HIV disease in these patients.~   "
272300|NCT00002047|"~     To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in~     HIV-infected patients in renal failure receiving maintenance hemodialysis.~   "
272301|NCT00002046|"~     To evaluate the pharmacokinetics of Retrovir (AZT) administered orally as 1 of 3 doses in the~     treatment of patients with severe clinical and laboratory manifestations of HIV infection. To~     compare the safety and tolerance of AZT administered 2, 3, and 6 x daily to these patients.~   "
272302|NCT00002045|"~     To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult~     patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in~     the treatment of HIV disease in these patients.~      (12/01/89) Information supplied by drug company update. Study discontinued due to positive~     data from ACTG 016.~   "
272303|NCT00002044|"~     The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the~     treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a~     lymphotropic and neurotropic virus which can affect both the central and peripheral nervous~     systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent~     state, with the potential for continuous reinfection of other body systems. Therefore,~     effective therapeutic efforts against HIV infection should provide effective antiviral~     activity within the nervous system.~   "
272304|NCT00002043|"~     To determine which of 2 doses of dapsone is effective prophylaxis for Pneumocystis carinii~     pneumonia (PCP) in patients with oral thrush or hairy leukoplakia and less than 400 CD4~     lymphocytes per mm3. To determine whether the long-term toxicities associated with daily~     dapsone in this population are tolerable.~   "
272305|NCT00002042|"~     To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or~     advanced AIDS related complex (ARC) and anemia secondary to their disease.~   "
272306|NCT00002041|"~     To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To~     compare the effectiveness of two different amphotericin B doses in the treatment of~     biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than~     standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and~     pharmacodynamic parameters of the two different dosing regimens.~   "
272307|NCT00002040|"~     To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial~     treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS~     patients. Both newly diagnosed and relapsed patients are eligible. The effectiveness of~     maintenance fluconazole therapy in sustaining a clinical cure in AIDS patients will also be~     evaluated.~   "
272308|NCT00002039|"~     To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS~     patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the~     safety and efficacy of three different foscarnet maintenance therapy regimens. To determine~     the pharmacokinetics of intermittent administration of foscarnet with or without concomitant~     administration of zidovudine (AZT).~   "
272309|NCT00002038|"~     The primary purpose of this protocol is to provide fluconazole for the treatment of~     individual patients who require therapy for serious or life-threatening systemic fungal~     infection, who have failed on conventional antifungal therapy or have had unacceptable~     reactions to conventional antifungal therapy, and who are ineligible for other established~     fluconazole clinical trial protocols.~   "
272310|NCT00002037|"~     To examine the effectiveness of subcutaneous gamma interferon in reducing severity of~     Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an~     open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety~     of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence~     and absence of AZT therapy.~   "
272311|NCT00002036|"~     To investigate the potential benefit of providing passive immunity with hyperimmune anti-HIV~     human serum.~   "
272312|NCT00002035|"~     To compare the efficacy and safety of orally administered didanosine (ddI) with orally~     administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical~     deterioration despite treatment with AZT.~   "
272313|NCT00002034|"~     To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly~     diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate~     the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety~     and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients~     utilizing treatment with other anti-retroviral drugs will be considered for study entry on a~     case by case basis.) To determine survival in this group of patients with AIDS and CMV~     retinitis.~   "
272314|NCT00002033|"~     To compare the effect of AS-101 to that of placebo on clinical efficacy and immunologic~     function in HIV positive patients with advanced disease. To compare the effect of AS-101 to~     that of placebo on occurrence of disease progression in HIV positive patients with advanced~     disease as defined by: (1) development of new diagnostically confirmed major opportunistic~     infection(s); or (2) development of AIDS-related dementia. To compare the effect of~     zidovudine (AZT) plus AS-101 versus AZT alone (placebo arm) on clinical efficacy and~     immunologic function in patients who require anti-viral therapy due to disease progression.~     Garlic capsules will be given to all study participants to mask the obvious garlic odor of~     AS-101.~   "
272315|NCT00002032|"~     The primary objectives of this trial are: To compare the safety of oral rifabutin versus~     placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients~     with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in~     these patients. A secondary objective is to compare clinical response, quality of life~     (Karnofsky), and survival between these two groups.~   "
272316|NCT00002031|"~     To evaluate the effect of application of Dinitrochlorobenzene (DNCB) on the number,~     morphology, and antigen expression of epidermal Langerhans cells in AIDS and AIDS related~     complex (ARC) patients.~   "
272317|NCT00002030|"~     To evaluate the safety, tolerability, and efficacy of long term, bi-weekly administration of~     aerosol pentamidine when used as a prophylactic agent in patients who have had at least two~     or more episodes of AIDS-associated Pneumocystis carinii pneumonia (PCP).~   "
272318|NCT00002029|"~     To compare two lipid emulsions in the long-term parenteral alimentation of patients with AIDS~     in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as~     measured by p24 antigen levels. Effect on relative HIV infectivity.~   "
272355|NCT00001992|"~     To test the safety and immunogenicity of rgp 120/HIV-1IIIB vaccine in HIV-1 seropositive~     adult patients.~   "
272319|NCT00002028|"~     The objective of this treatment IND protocol is to make didanosine (ddI) available to~     patients with HIV infection (suffering from AIDS related complex (ARC) or AIDS) who have~     developed documented intolerance to zidovudine (AZT) and cannot enter a Phase II ddI program~     due to protocol exclusion or geographic location.~   "
272320|NCT00002027|"~     To evaluate the safety and efficacy of diclazuril capsules compared with placebo capsules as~     treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be~     based on the drug's clinical results and on its anti-protozoan effects. Safety will be~     assessed by the occurrence of side effects as reported by patients at their visits and by~     frequent monitoring of hematology, biochemistries, and urinalysis.~   "
272321|NCT00002026|"~     To evaluate the efficacy of oral acyclovir for the treatment and suppression of Epstein-Barr~     virus (EBV) related hairy leukoplakia (HL). To determine the long-term safety of acyclovir in~     the AIDS-related complex (ARC) patient with HL. To monitor the progression of HIV disease in~     the HL patient and compare to existing historical control data.~   "
272322|NCT00002025|"~     To make intravenous (IV) ganciclovir available to immunocompromised patients with~     life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of~     the disease are too severe to allow admission to a controlled clinical study of ganciclovir~     therapy. To determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir~     IV followed by a maintenance course of ganciclovir IV for an indefinite duration. To tabulate~     the patient's clinical response.~   "
272323|NCT00002024|"~     To provide ganciclovir on a compassionate use basis to immunocompromised patients with~     serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient~     population.~   "
272324|NCT00002023|"~     To establish the relationship between the oral dose of zidovudine (AZT) and its hematologic~     toxicity. AZT has preliminarily been shown to decrease significant events and death in a~     group of AIDS / Pneumocystis carinii pneumonia (PCP) and AIDS related complex (ARC) patients~     followed at this time for a limited period. If these data withstand further follow-up, it~     appears that AZT is a potential antiretroviral agent that may have application in the use of~     all stages of HIV disease. At this time the optimal dose that will not cause significant~     toxicity is not known. If this drug has widespread application, it becomes imperative to~     further study both the dose and the toxicity. Patients with documented HIV viremia and who~     are well will be evaluated in a dose-escalating protocol for toxicity, persistent viremia,~     evidence of improvement of immune dysfunction, and the development of further manifestation~     of HIV disease. Drug levels will be monitored and correlated with the toxicity and viremia.~   "
272325|NCT00002022|"~     The objective of the Eprex (erythropoietin) Treatment Program is to provide erythropoietin~     for the treatment of anemia in AIDS patients.~   "
272326|NCT00002021|"~     To evaluate the safety and efficacy of intermittent intravenous (IV) foscarnet in the~     treatment of acyclovir-resistant herpes simplex virus (HSV) infections in AIDS patients and~     other immunocompromised patients. To evaluate the necessity, efficacy, and safety of IV~     maintenance foscarnet therapy in preventing recurrent disease. To confirm the~     pharmacokinetics of intermittent induction and maintenance IV regimens.~   "
272327|NCT00002020|"~     To evaluate the safety and tolerance, in patients with severe clinical manifestations of HIV~     infection, of zidovudine (AZT) administered daily for 48 weeks as a low dose every 4 hours or~     a higher dose every 12 hours.~   "
272328|NCT00002019|"~     To evaluate the safety, tolerance and efficacy of three different dosage regimens of~     Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B) in patients with~     AIDS and cryptococcal meningitis.~   "
272329|NCT00002018|"~     To conduct a double-blind, randomized, dose ranging study of an orally administered low dose~     interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.~   "
272330|NCT00002017|"~     To evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2~     (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking~     zidovudine (AZT). To enhance measures of immune function with well-tolerated doses of~     PEG-IL-2, an immunomodulator, in a regimen designed to allow its use in outpatients with~     normal daily activity (i.e., full-time employment, etc.). Recombinant IL-2 (without PEG~     modification) was administered to HIV-infected patients by daily intradermal injection. At~     the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as~     measured by natural killer cell and lymphokine-activated killer cell activity, but required~     daily administration. In the current study, the PEG modification of IL-2 is used since it has~     a much longer prolonged half-life compared with the non-PEG compound, without loss of~     functional activity.~   "
272331|NCT00002016|"~     To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV)~     monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses~     during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and~     documented evidence of CMV retinitis. In addition for those patients with positive CMV~     cultures upon entry into this trial a preliminary attempt will be made to assess the~     potential in vivo antiviral effects of the concomitant administration of DHPG and SDZ~     MSL-109.~   "
272332|NCT00002015|"~     To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12~     years). To determine the safety and tolerance of a 2 to 3 week induction course of~     ganciclovir IV in immunocompromised children receiving treatment for life- or~     sight-threatening cytomegalovirus infections.~   "
272333|NCT00002014|"~     To determine the safety and tolerance of various combinations of zidovudine (AZT) and~     didanosine (ddI) administered concurrently. To determine the pharmacokinetics of concurrent~     AZT and ddI administered orally. To evaluate the antiviral, immunologic and virologic effects~     of AZT and ddI administered concurrently.~   "
272334|NCT00002013|"~     To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for~     three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS~     related complex (ARC).~   "
272335|NCT00002012|"~     To conduct a parallel-group, double-blind, randomized, placebo-controlled study to evaluate~     the safety and efficacy of an orally administered low dose interferon alfa-n3 as an~     immunomodulator in the treatment of mild to moderate symptomatic HIV+, AIDS-related complex~     (ARC) patients.~   "
272336|NCT00002011|"~     To determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal~     photopheresis) in the Treatment of AIDS-Related Complex (ARC).~   "
272337|NCT00002010|"~     The study is intended to examine the efficacy of fluconazole for the treatment of~     coccidioidal meningitis in patients with new onset of infection, relapse of previous~     infection, or failed previous therapy. Drug efficacy, safety and tolerance will be examined.~   "
272338|NCT00002009|"~     To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant~     granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous~     infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In~     addition, single dose and steady state pharmacokinetics will also be determined.~   "
272339|NCT00002008|"~     To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of~     sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human~     granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC )~     injection to patients with leukopenia in association with HIV infection.~   "
272340|NCT00002007|"~     To evaluate the safety of repeated courses of sargramostim ( recombinant~     granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to~     patients with HIV infection and leukopenia. To determine if administration of GM-CSF will~     prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment~     in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits~     from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV~     infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP~     ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.~   "
272341|NCT00002006|"~     To assess the safety and efficacy of subcutaneously administered sargramostim (~     granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the~     neutrophil count in HIV-infected adults who have developed neutropenia as a result of~     receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of~     subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in~     HIV-infected adults with pre-existing neutropenia who are at high risk of developing~     hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To~     assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history~     of HIV infection and associated infectious complications.~   "
272342|NCT00002005|"~     To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human~     CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To obtain a~     preliminary indication of the antiviral effects of rCD4 in patients with AIDS and ARC. To~     measure steady state serum levels of rCD4 following continuous infusion therapy.~   "
272343|NCT00002004|"~     To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human~     CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To assess~     pharmacokinetic properties of rCD4 in humans. To obtain a preliminary indication of the~     antiviral effects of rCD4 in patients with AIDS and AIDS related complex (ARC).~   "
272344|NCT00002003|"~     To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride (~     Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.~   "
272345|NCT00002002|"~     The primary objective of the study is to evaluate the effectiveness of l-leucovorin in~     preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a~     therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.~   "
272346|NCT00002001|"~     To evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To~     evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined~     administration of zidovudine and ddI or ddC for clinical efficacy. To evaluate the safety and~     the tolerance of the coadministration of zidovudine and ddI or ddC.~   "
272347|NCT00002000|"~     To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir~     in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or~     equal to 100).~   "
272348|NCT00001999|"~     To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response~     as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration~     of remission than DHPG alone (i.e. 16 weeks). To evaluate the toxicities of the combination~     of DHPG and immune globulin as compared to those of DHPG alone. To evaluate if there is a~     difference between the two groups in regard to survival, immune functions, and CMV viremia~     and viruria.~   "
272349|NCT00001998|"~     To define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human~     subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of~     4 dose levels.~   "
272350|NCT00001997|"~     To investigate the safety of polyethylene glycolated interleukin-2 (PEG IL-2) given~     subcutaneously in conjunction with antiviral treatment and to explore the effects of~     treatment on surrogate markers of efficacy and incidence of opportunistic infection and other~     clinical markers of HIV disease.~   "
272351|NCT00001996|"~     To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the~     treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are~     intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the~     incidence of premature discontinuation of therapy due to toxicity. To compare the efficacy of~     566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the~     same population.~   "
272352|NCT00001995|"~     To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of~     Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with~     MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug~     regimen.~   "
272353|NCT00001994|"~     To evaluate the safety and tolerance of atovaquone (566C80) in AIDS patients with central~     nervous system (CNS) toxoplasmosis. To evaluate the efficacy of 566C80 in the acute treatment~     and suppression of CNS toxoplasmosis in AIDS patients who fail or who cannot tolerate~     conventional therapy.~   "
272354|NCT00001993|"~     The primary objective of this study is to determine the preliminary efficacy and tolerability~     of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic~     HIV+ patients with 200 to 500 CD4+ cells/mm3.~      The secondary objective is to determine the pharmacokinetics and bioavailability of both~     SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500~     CD4+ cells/mm3.~   "
272356|NCT00001991|"~     To facilitate provision of atovaquone (566C80) to patients who have mild to moderate~     Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim /~     sulfamethoxazole (TMP / SMX ); to monitor serious adverse events attributable to 566C80.~   "
272357|NCT00001990|"~     To facilitate provision of atovaquone (566C80) to patients who have severe Pneumocystis~     carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim /~     sulfamethoxazole ( TMX / SMX ); to monitor serious adverse events attributable to 566C80.~   "
272358|NCT00001989|"~     This study involves GLQ223 administration to patients who have not previously been exposed to~     it, but who have received at least 9 months of zidovudine therapy. Efficacy evaluations will~     include survival, opportunistic infections, T4 cell count, and assessments of viral load.~   "
272359|NCT00001137|"~     The purpose of this study is to determine what combinations of anti-HIV drugs work best in~     patients treated over several years. The study will also assess the occurrence of side~     effects and opportunistic infections in patients with low viral loads compared to those with~     higher viral loads.~   "
272360|NCT00001136|"~     The purpose of this study is to see if it is safe to give an HIV vaccine (vCP205) to~     volunteers who received an HIV vaccine at least 2 years ago, and to study how the immune~     system responds to this vaccine.~      Vaccines are given to people to try to resist infection or prevent disease. There are a~     number of different HIV vaccines that are currently being tested. The vaccines that seem to~     be the most promising are canarypox vaccines, known as ALVAC vaccines; the vaccine tested in~     this study is ALVAC-HIV vCP205. This study will look at the safety of the vaccine and how the~     immune system responds to it.~   "
272361|NCT00001135|"~     The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to~     HIV-positive pregnant women and their infants can help reduce the chance that a mother will~     give HIV to her baby during delivery.~      NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to~     their infants. NVP is inexpensive and is easily absorbed by the mother and transferred to the~     infant. It is thought that even a single dose to the mother and infant may provide enough~     protection to the baby during the time of exposure to HIV at birth.~   "
272362|NCT00001133|"~     In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in~     patients who have high levels of virus while taking other protease inhibitors. The purpose of~     this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This~     study will also look at any side effects that IDV or RTV causes.~      IDV is an effective anti-HIV drug, but it can be difficult for patients to take. For IDV to~     work against HIV, it must be taken 3 times a day at a high dose and with a certain diet.~     Doctors believe IDV may be easier to take if it is given with RTV. Patients who take IDV and~     RTV together may be able to take IDV only twice a day and at a lower dose. This study will~     gather information about the safety and side effects of using IDV and RTV together.~   "
272363|NCT00001132|"~     The purpose of this study is to see if adding 1 drug to an anti-HIV drug combination early in~     treatment against HIV can lower the viral load (amount of HIV in the blood) to a level so low~     that it cannot be measured (undetectable). The drug that will be added to a treatment is~     abacavir (ABC).~      Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads,~     for example, viral loads below 50 copies/ml. However, some patients taking only 3 drugs are~     not able to achieve a viral load this low. Doctors hope that, by adding the drug ABC to a~     current treatment, a viral load below 50 copies/ml can be achieved. Doctors would like to~     find out if it is effective to start patients on 3 drugs and then add another drug (treatment~     intensification) if the treatment is not working as well as hoped.~   "
272364|NCT00001131|"~     The purpose of this study is to find out if the immune systems of HIV-positive patients can~     be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early~     stages of HIV infection.~      IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV~     spreads throughout the body by invading CD4 cells, which are cells of the immune system that~     fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can~     help restore the CD4 cell count and the immune functions. This study will look at how the HIV~     virus acts during the early stages of HIV infection, how the immune system responds to HIV,~     and what impact early treatment with anti-HIV medications has on the course of HIV infection.~   "
272365|NCT00001130|"~     The purpose of this study is to identify patients who have early HIV infection. Patients who~     have been infected with HIV recently may develop flu-like symptoms within 3 to 8 weeks. Those~     who go to the hospital emergency room for these symptoms and who may have been exposed to HIV~     recently will be given a questionnaire and the opportunity to be tested for HIV.~      Most people develop flu-like symptoms shortly after becoming infected with HIV, and many of~     these people go to a hospital emergency room for treatment. However, most doctors do not~     think of testing people with flu-like symptoms for HIV. This study will look at a plan to~     change this because it is very important to identify patients who have early HIV infection.~     Viral load (level of HIV in the blood) is very high during early HIV infection, and it is~     easy to spread HIV to others during this period. Patients who learn they are HIV-positive can~     stop risky behavior that might spread HIV to other people. Also, patients who find out early~     that they are HIV positive are able to begin anti-HIV treatment sooner, slowing the disease.~   "
272366|NCT00001129|"~     The purpose of this study is to look at different ways to help patients follow their anti-HIV~     medication schedules.~      It is very important that HIV-positive patients take their anti-HIV medications correctly so~     they get the best possible benefit from them. Taking the drugs correctly, called adherence,~     may keep HIV virus levels in the blood (viral load) low for a longer time. However, anti-HIV~     medication schedules are often complicated, and many patients have difficulty remembering to~     take their drugs at the correct time. This study will look at 2 different ways to teach~     patients about the importance of taking their medications correctly and to remind them when~     to take their medications.~   "
272399|NCT00001093|"~     The purpose of this study is to find out if it is effective to give aggressive anti-HIV~     therapy to patients who have been infected recently with HIV.~      Many doctors recommend that patients who have recently been infected with HIV begin anti-HIV~     treatment as soon as possible. However, early HIV infection is not yet completely understood,~     so it is not known if this is the best approach. This study will look at the effects of~     beginning anti-HIV treatment during early HIV infection.~   "
272367|NCT00001128|"~     The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12)~     to the standard drug combination (paromomycin plus azithromycin) used to treat~     cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of~     IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin~     alone.~      Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive~     patients as their immune systems weaken. It is caused by a parasite that invades the~     intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a~     fever. Antibiotics (paromomycin and azithromycin) are usually used to treat~     cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12.~     IL-12 is a type of protein naturally produced by certain types of cells of the immune system~     and is believed to be important for immune function. Doctors hope that IL-12 can help boost~     the immune system in fighting cryptosporidiosis.~   "
272368|NCT00001127|"~     This study tests the safety and effectiveness of a flu vaccine in school children.~      School children are usually the first members of a community to come down with the flu, and~     they often give the flu to their younger siblings, parents, and grandparents. It is hoped~     that giving school children a flu vaccine can help prevent the spread of the flu to other~     members of the community.~   "
272369|NCT00001126|"~     The purpose of this study is to see what dose of the drug cidofovir is safe to treat~     laryngeal papillomatosis (warts in the throat which occur over and over) in children.~      Laryngeal papillomatosis is caused by infection with a virus called human papillomavirus~     (HPV). At present, there is no approved drug to treat this infection. However, cidofovir is a~     drug effective against several viruses. Cidofovir may be able to attack the HPV virus. This~     study tests the safety of giving this drug to children.~   "
272370|NCT00001125|"~     The purpose of this study is to see if the varicella-zoster virus (VZV) vaccine will be safe~     and if it can help prevent shingles in HIV-infected children who have already had chickenpox.~      VZV is the virus that causes chickenpox. If this virus is reactivated in the body, it can~     also cause shingles. Shingles is common in children with HIV who have had chickenpox,~     although it is usually not life-threatening. The VZV vaccine used in this study may be able~     to prevent HIV-positive children who have had chickenpox from developing shingles.~   "
272371|NCT00001123|"~     The purpose is to test the safety and effectiveness of intravenous ribavirin therapy in~     persons with suspected and subsequently proven hantavirus infection. The hantavirus is spread~     through the air into the lungs when dry rodent feces are moved or disturbed. It is~     characterized by fever and bleeding.~   "
272372|NCT00001122|"~     The purpose of this study is to see if observed therapy can help HIV-positive patients stick~     to their anti-HIV medication schedule. Observed therapy means that a nurse will watch~     patients take their medications to make sure that they take them correctly.~      It is very important that HIV-positive patients take their anti-HIV medications correctly so~     they get the best possible benefit from them. Taking the drugs correctly, called adherence,~     may keep HIV virus levels in the blood (viral load) low for a longer time. Adherence can also~     slow the development of drug resistance, and this is especially important in patients with~     early HIV infection who are just beginning treatment. However, anti-HIV medication schedules~     are often complicated, and many patients have difficulty remembering to take their drugs at~     the correct time. This study will look at the effectiveness of a plan to help patients with~     this problem.~   "
272373|NCT00001121|"~     The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that~     occurred in association with known, but discouraged, high-risk behaviors in persons who have~     received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these~     patients respond to HIV infection in order to develop new HIV vaccines and other treatments~     for HIV and AIDS.~      Patients who receive HIV vaccines are sometimes protected from HIV infection. More often,~     these patients become HIV-positive but experience a boost in their immune system that helps~     their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection~     in order to develop new HIV vaccines and other treatments for HIV and AIDS.~   "
272374|NCT00001120|"~     The purpose of this study is to find out why cancers develop in HIV-positive patients.~      Cancer is a leading cause of death in AIDS patients. Common cancers in HIV-infected patients~     include Kaposi's sarcoma (KS) and non-Hodgkin's lymphoma (NHL), a cancer of the immune~     system. Risk factors include certain chemicals, viruses, and perhaps even anti-HIV drugs.~     Doctors would like to find out which risk factors are most important and how they relate to~     cancer in AIDS patients.~   "
272375|NCT00001119|"~     The purpose of this study is to find out whether these powerful combinations of anti-HIV~     drugs are safe and effective for use in patients in the early stages of HIV infection and to~     find out how patients' immune systems react to HIV and anti-HIV drugs.~      Doctors generally treat patients in the early stages of HIV infection with the same anti-HIV~     drugs taken by patients who have had HIV for a long time. These drugs lower the level of HIV~     in the blood. However, doctors do not know whether patients who take anti-HIV drugs in the~     early stages of HIV infection actually live longer or have fewer AIDS-related diseases. This~     study will help doctors answer these questions. In the main study, doctors will look at how 2~     different anti-HIV drug combinations affect the immune system. In the 2 substudies, doctors~     will look at how the body reacts to the hepatitis B vaccine and the tetanus vaccine. These~     substudies may help doctors learn how HIV-infected patients respond to new infections.~   "
272376|NCT00001118|"~     The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to~     treat HIV-infected children.~      T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells~     (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug~     combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a~     nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).~   "
272377|NCT00001117|"~     This study evaluates patients infected with both HIV and Hepatitis C virus (HCV) who are~     receiving anti-HIV drugs. The purpose of this study is to learn more about HCV infection in~     patients whose HIV blood level decreases to less than 500 copies/ml.~   "
272478|NCT00001013|"~     To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus~     leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the~     treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have~     AIDS, are HIV positive, or are at high risk for HIV infection.~   "
272378|NCT00001116|"~     The purpose of this study is to determine if TNFR:Fc (a molecule that attaches to TNF) can~     lower the amount of IL-6 in HIV-positive patients. This study will also examine the effect of~     TNFR:Fc on TNF-alpha. IL-6 and TNF-alpha are 2 substances produced by the immune system that~     may increase the rate of HIV replication.~      IL-6 and TNF-alpha are produced naturally by the body. High levels of TNF-alpha lead to~     increased IL-6 production and increased HIV replication, therefore helping the virus infect~     the body. HIV-positive patients who receive IL-2 (interleukin-2, a protein that helps the~     immune system fight infection) tend to have higher levels of IL-6 and TNF-alpha than patients~     not receiving IL-2. These increased levels may contribute to some of the flu-like symptoms~     related to IL-2 administration. TNFR:Fc can neutralize TNF-alpha to decrease the action of~     TNF-alpha and, in turn, decrease the amount of IL-6 in the body. TNFR:Fc may, therefore, have~     a role in the treatment of HIV disease or in relieving some of the symptoms related to IL-2~     administration.~   "
272379|NCT00001115|"~     Part A: To evaluate the impact of HSV suppression with acyclovir ( ACV ) on HIV burden in~     patients with asymptomatic HSV infection and at high risk for HSV reactivation.~      Part B: To characterize the change in plasma HIV RNA levels and other measures of HIV burden~     during and after a 10 day course of ACV treatment for acute HSV infection.~      Approximately 70% of patients infected with HIV are concurrently infected with HSV. There is~     new evidence to suggest that HSV may act as a co-factor in HIV disease progression. This~     study will attempt to determine if the upregulation of HIV RNA that occurs during symptomatic~     HSV reactivation also occurs during asymptomatic HSV reactivation and if suppression of HSV~     will result in decreased levels of HIV RNA. There is a need to determine the patterns of~     association between HSV and HIV.~   "
272380|NCT00001114|"~     Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon~     alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's~     sarcoma associated with HIV infection.~      Secondary: To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression~     and markers of immune function.~      Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and~     suppression of HIV in some patients. Although various trials using IFN-alpha in combination~     with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity~     and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these~     two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may~     be better tolerated than zidovudine when combined with IFN-alpha.~   "
272381|NCT00001113|"~     To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's~     sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon~     alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics~     of AZT and IFN-A or AZT and IFN-A2A when given in combination. To define the maximum~     tolerated dose (MTD) of each drug in combination and to define doses to be used in Phase II~     trial. AZT has been found to be effective against the effects of HIV in vitro (test tube) and~     both interferons have shown antiviral and antitumor effect on Kaposi's sarcoma. It is~     reasonable to assume that a synergism and an enhanced antitumor response may be seen with~     combination therapy. A study to evaluate the safety and effectiveness of AZT in the~     combination with IFN-A2A is warranted.~   "
272382|NCT00001112|"~     To find out which of four doses of (recombinant) human interferon gamma (IFN-G) is most~     effective in stimulating the white blood cells (monocytes) to fight infection and to see if~     treatment with IFN-G can strengthen the ability of AIDS patients to control infections. This~     study will also determine how long after a single injection of IFN-G white blood cells remain~     stimulated.~      AIDS is a disease that progressively destroys that aspect of the body's defense called the~     immune system. It is particularly harmful to a class of cells called helper T-lymphocytes.~     The specific opportunistic infections and malignancies associated with AIDS have been treated~     with therapies that are often poorly tolerated by the patients and are associated with~     dose-limiting toxicities. The principal focus of AIDS therapy research at present is to~     control the underlying retroviral infection and to restore immune function with recombinant~     lymphokines, adoptive immunotherapy, and/or lymphocyte transplants. These treatments include~     zidovudine (AZT), which has been shown to control the HIV infection, and IFN-G, a lymphokine~     which activates tumor-destroying and germ-killing functions. Studies are needed to find the~     dose by which IFN-G works best.~   "
272383|NCT00001111|"~     Monotherapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and~     preliminary activity of nevirapine administered alone in mildly to moderately symptomatic~     HIV-infected children ages 2 months to less than 18 years; to evaluate and compare the~     safety, tolerance, and pharmacokinetics of nevirapine in HIV-infected children ages 1 day to~     less than 2 months. Combination therapy phase: To evaluate and compare the safety, tolerance,~     pharmacokinetics, and preliminary activity of nevirapine administered in combination with~     zidovudine (AZT) in mildly to moderately symptomatic HIV-infected children ages 2 months to~     less than 18 years.~      Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic~     than the nucleoside analogues are needed. Nevirapine (BI-RG-587) has shown in vitro~     inhibitory activity against HIV-1reverse transcriptase and has shown a synergistic inhibition~     of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction assay.~   "
272384|NCT00001110|"~     The purpose of this study is to see: (1) how the amount of HIV in the lungs compares to that~     in the blood; (2) if HAART reduces the amount of HIV in the lungs; and (3) if HAART reduces~     lung inflammation in HIV-infected patients.~      Lung-cell inflammation in HIV-infected patients is probably caused by HIV infection of these~     cells. The amount of inflammation may correspond to the amount of HIV (viral load) in the~     lungs (i.e., mild inflammation indicates a low amount of HIV; severe inflammation indicates a~     high amount of HIV). HAART is used to decrease the amount of HIV in the body. If HAART is~     able to decrease viral load in the lungs, it should also be able to decrease lung-cell~     inflammation in these patients.~   "
272385|NCT00001109|"~     The purpose of this study is to learn more about some of the immune cells in the blood (CD4~     cells, for example) of healthy children in order to better understand the differences in the~     blood cells of children infected with HIV.~      Because children's bodies are still developing, their cells are different from those of~     adults, and their bodies respond differently to infections such as HIV. In order to~     understand how immune cells grow and mature so that they can fight HIV, it is important to~     see how these cells behave in normal children.~   "
272386|NCT00001108|"~     The purpose of this study is to see if 7 drugs, some of them given at higher doses than~     normal, are safe and tolerated by young patients with AIDS who have failed to respond to~     other treatments. The study will also see what effect taking several anti-HIV drugs together~     at high doses has on the body's ability to fight HIV infection. The 7 drugs that will be~     given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir~     (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP).~      (This study has been changed from an 8-drug regimen to a 7-drug regimen. Patients no longer~     receive the drug hydroxyurea [HU].) Doctors are seeing many HIV-positive children who did not~     get good long-term results from the current anti-HIV drugs. Some doctors believe anti-HIV~     drugs fail because drug levels in the body are too low. In this study, doctors will give~     patients 7 drugs, some at higher doses than normal. Since it is very important that patients~     on the study take all of these drugs, doctors will make it as easy as possible. Doctors want~     to try this because children with advanced AIDS have few treatment choices.~   "
272387|NCT00001107|"~     The purpose of this study is to compare the safety and effectiveness of 2 treatments to~     prevent invasive fungal infections (IFI), which are infections caused by yeasts and molds~     that are common in patients with weak immune systems or transplant patients. AmBisome, a new~     treatment, will be compared to fluconazole, the traditional treatment for fungal infections~     caused by the yeast Candida. Treatment will only be given to liver transplant patients who~     are found to be at high risk for IFI. Liver transplant patients who are at low risk for IFI~     will be monitored but will receive no study medication.~      IFIs are found mainly in a high risk group of liver transplant patients, and are not common~     in those with low risk. If IFI preventive therapy is focused on the high risk group, there~     may be a lesser chance of Candida becoming resistant (able to grow despite the presence of~     drugs used to kill it). Treating only the high risk group will also save money.~   "
272388|NCT00001106|"~     AMENDED: To evaluate the pharmacokinetics of intravenously administered AZT to HIV-1 infected~     pregnant women in labor; to evaluate the pharmacokinetics and urinary excretion of AZT and~     its metabolites in newborns of HIV-1 infected mothers who receive IV AZT only during labor;~     to evaluate the safety of IV AZT administered by continuous infusion to HIV-1 infected~     laboring women and their infants. Original design: To determine the distribution and~     elimination of zidovudine (AZT) in the body as well as its safety in the treatment of~     pregnant women and their unborn children. The information derived from this study is required~     in order to design a future study that will assess the efficacy of AZT in reducing the~     transmission rate of HIV-1 from seropositive women to their fetus by treating them during the~     third trimester of pregnancy.~      An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to~     their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously~     demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult~     patients; benefits of treatment include decreased mortality rate, decreased incidence of~     opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children,~     however, have resulted in uncontrolled information regarding clinical efficacy. The present~     study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and~     oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the~     safety and efficacy of such treatment in their newborns.~      It is hoped that the results will be instrumental in designing future studies to assess the~     efficacy of AZT in reducing the transmission risk of HIV-1.~   "
272389|NCT00001105|"~     To determine the safety and pharmacokinetics of F105 human monoclonal antibody both following~     a single dose and during intermittent administration in HIV-infected patients. To determine~     specific dose concentrations sufficient to achieve efficacy and avoid toxicity. To determine~     the effect of F105 on virologic, immunologic, and serologic parameters.~      Early in the course of HIV infection, the primary humoral immune response appears to be~     highly strain specific and to be directed at a hypervariable portion of the viral gp120. The~     F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown~     to neutralize the IIIB, SF2, and MN strains of HIV at concentrations readily achievable in~     humans.~   "
272390|NCT00001104|"~     Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the~     disease process in hemophilic patients who have HIV infection with no symptoms. The major~     clinical question is whether patients who receive chronic ZDV therapy will have a delay in~     the development of AIDS or AIDS-related complex (ARC). The pharmacokinetics (blood levels) of~     ZDV in hemophilic patients will also be studied.~      Study B: To determine if ZDV therapy changes the risk of a hemophiliac transmitting HIV to~     his wife or other female sexual partner. To determine the effectiveness of counseling and~     education on the behaviors of the wives that place them at risk for HIV infection. To~     determine if antibodies to HIV either appear or disappear from the blood of any of the wives~     during the study.~      Study A: Individuals who are infected with HIV can benefit from therapy with an effective~     anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in~     humans at the dose planned. It may be effective in preventing the development of AIDS or ARC~     in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are~     especially important because the high prevalence of hepatic disease in this population may~     affect the metabolism and blood levels of ZDV.~      Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have~     become infected during long-term sexual relationships. Transmission of the virus does not~     occur during casual family contact. This study will aid in determining if therapy influences~     the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV~     infection other than sexual contact with their spouse.~   "
272391|NCT00001103|"~     The purpose of this study is to see whether anti-HIV drugs that reduce HIV in the blood also~     reduce HIV in the cerebrospinal fluid (CSF). CSF is the fluid found around the brain and~     spinal cord. This study also looks at whether reducing HIV in the CSF can help protect brain~     function.~      HIV can be detected in the brain and CSF early in HIV disease. Anti-HIV drugs probably reduce~     HIV in the CSF. This may be important because other studies have suggested high CSF HIV~     levels may lead to some loss of brain function.~   "
272541|NCT00000950|"~     The purpose of this study is to determine if a relationship exists between the level of~     antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and~     the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these~     drugs are absorbed and metabolized in the body.~   "
272392|NCT00001102|"~     The purpose of this study is to see how taking certain anti-HIV drugs affects the way the~     body metabolizes fat. This study will evaluate patients who are enrolled in CPCRA 058 (the~     FIRST [Flexible Initial Retrovirus Suppressive Therapies] study) by looking for changes in~     cholesterol levels, levels of fat in the blood, and body fat distribution. Patients in the~     FIRST study receive an anti-HIV drug regimen which contains a protease inhibitor (PI), a~     nonnucleoside reverse transcriptase inhibitor (NNRTI), or both.~      Anti-HIV drug therapy using PIs has become very common treatment for HIV-positive patients.~     Recently, however, serious side effects involving how the body uses fat are being reported in~     patients taking PIs. Examples of these side effects are a redistribution of body fat, high~     cholesterol level, and development of diabetes. However, some of these side effects have also~     been seen in patients who are not taking PIs. It is important to determine whether or not~     these side effects are directly related to PI use. In this study, patients on different drug~     combinations, either with or without a PI, will be compared.~   "
272393|NCT00001101|"~     Lyme disease is the most common tick-borne disease in the United States. It is caused by the~     spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1)~     active infection by B. burgdorferi; 2) damage caused by the original infectious process; or~     3) the presence of co-infection with another organism transmitted by Ixodes ticks. The~     purpose of this study is to determine the safety and effectiveness, for seropositive~     patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease~     (CLD).~   "
272394|NCT00001100|"~     The purpose of this study is to evaluate the benefits and safety of the antiviral drug~     ganciclovir (DHPG) given intravenously to treat newborn infants who are born infected with~     cytomegalovirus (CMV). CMV is a herpes virus that can infect most organs of the body,~     resulting in death in 10-30% of babies with symptoms of CMV. It can cause severe brain damage~     in a large percentage of surviving babies. Children in this study have a CMV infection of the~     central nervous system (CNS).~   "
272395|NCT00001097|"~     The purpose of this study is to see if children and young adults with better immune systems~     before starting highly active antiretroviral therapy (HAART) do better than those who have~     weaker immune systems before starting HAART.~      HIV infection weakens the immune system's ability to fight other infections and diseases.~     HAART is a type of anti-HIV therapy shown to improve the immune system of adults. However,~     not all patients show the same amount of improvement with HAART. Doctors believe that results~     may depend on how strong a patient's immune system is before starting HAART. Long-term~     effects of HAART in children and young adults have not yet been studied.~   "
272396|NCT00001096|"~     To assess the safety and immune response to two experimental vaccines when formulated with~     QS-21 or QS-21 plus alum. To determine whether the new preparation of QS-21 in polysorbate 80~     is less reactogenic than the QS-21 formulation used in AVEG Protocols 016, 016A, and 016B. To~     examine whether QS-21 is immunologically equivalent to that used in 16B. To determine if~     QS-21, when given with low doses of antigen, induces measurable HIV-1-specific CTL activity.~     To evaluate if the QS-21 dose-sparing effect extends to an antigen dose of 0.5 micrograms. To~     determine if the bivalent vaccine gives responses equivalent to the monovalent product or if~     a broadening of the HIV-1-specific binding and neutralizing antibody responses occurs.~      An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted~     immunologic responses. Required parts of the immune response may include: humoral antibodies,~     which broadly neutralize non-syncytium-inducing strains of HIV-1; T cell help provided by~     both CD4 and CD8 positive subsets; and a class I-restricted cytotoxic lymphocyte response.~     Other effector responses, such as the generation of antibody-dependent cellular cytotoxicity,~     cytokines, chemokines, or other antiviral factors may also be critical in mounting protective~     immunity. Given the lack of a surrogate immunologic marker, the most practical approach for~     possible efficacy trials would be to evaluate a candidate vaccine that elicits as many of~     these responses as possible.~   "
272397|NCT00001095|"~     To determine the proportion of patients treated with amprenavir, zidovudine (ZDV), stavudine~     (D4T) and lamivudine (3TC) whose HIV-1 RNA level remains below the level of detection during~     96 weeks of therapy. To determine the proportion of patients treated with indinavir (IDV),~     nevirapine (NVP), 3TC, and d4T whose HIV-1 RNA level decreases and then remains below the~     level of detection, during the 96-week therapy period. To determine the viral effects,~     safety, tolerability, and pharmacokinetics of amprenavir in combination with zidovudine,~     stavudine, and lamivudine. [AS PER AMENDMENT 2/27/98: To determine the proportion of patients~     with undetectable plasma HIV RNA, by treatment and baseline RNA cohort (either detectable or~     undetectable). To determine the durability of these regimens by estimating the distribution~     of time to loss of virologic suppression (or equivalently, time to virologic failure), by~     treatment and baseline RNA cohort.] This study allows patients who have successfully~     participated in ACTG 347 or other trials involving amprenavir to continue treatment with~     amprenavir, ZDV, d4T, and 3TC. Additionally, this study provides patients whose HIV-1 RNA was~     not reduced to undetectable levels or who had a significant increase in plasma levels~     (treatment failures) the opportunity to change to a potentially more active regimen that~     includes indinavir, nevirapine, lamivudine, and stavudine.~   "
272398|NCT00001094|"~     To compare the long-term virologic response to combination therapy with two protease~     inhibitors, i.e., nelfinavir (NFV) + saquinavir soft gel capsule (SQVsgc) and delavirdine~     (DLV) or combination lamivudine/zidovudine (3TC/ZDV, Combivir) versus NFV and 3TC/ZDV, in the~     proportion of patients demonstrating virologic success (< 500 copies/ml HIV RNA) at week 48,~     without prior virologic or clinical failure. To evaluate the safety and tolerance of~     combination protease inhibitors.~      To evaluate the durability of virologic response as assessed by the Roche Ultra Sensitive~     assay (< 200 copies/ml) and culturable virus. To compare time to a confirmed virologic~     response (two consecutive plasma HIV RNA levels < 500 copies/ml) or to a confirmed treatment~     relapse following a confirmed virologic response across the treatment arms. To evaluate~     biologic phenotype (non-syncytium inducing versus syncytium inducing capacity) and the~     evolution and patterns of viral resistance among patients with confirmed treatment failures~     at or after weeks 16 to 24. To compare immunologic benefits, as measured by longitudinal~     CD4/CD8 cell count profiles. To evaluate the influence of baseline virologic and immunologic~     parameters on the magnitude and duration of plasma HIV RNA response. To compare virologic~     response between the two dose schedules of NFV and SQVsgc (bid vs tid) and between NFV and~     SQVsgc with either DLV or combination 3TC/ZDV. To evaluate compliance and exploratory~     population pharmacometrics.~      Past studies have shown that combination therapies not only will result in better clinical~     outcomes but may prolong the effects of therapy. The enhanced effects seen with combination~     therapies are likely related to a greater suppression of HIV replication and alterations in~     resistance patterns. Both in vitro and in vivo studies suggest that triple-drug therapy may~     have an advantage over one- and two-drug regimens. Therefore, triple-drug therapy appears to~     be an important strategy in the treatment of HIV infection.~   "
272400|NCT00001092|"~     The purpose of this study is to look at the amount of HIV in the blood, genital fluid, and~     saliva of the partners of patients with early HIV infection. This study will also look at the~     strength of the immune systems of patients with early HIV infection.~      Because HIV multiplies very quickly in the early stages of infection, patients with early HIV~     infection may be more likely to transmit HIV to their partners. The amount of HIV in blood,~     genital fluid, and saliva may determine the risk for transmission.~   "
272401|NCT00001091|"~     The purpose of this study is to see if it is safe and effective to give HIV-infected children~     and teens 1 of 4 anti-HIV drug combinations.~      Decreasing HIV levels in infected patients can slow down disease progression. Further study~     is needed to find out which drug combinations are most effective in doing this.~   "
272402|NCT00001090|"~     To evaluate the safety and immunogenicity of live recombinant canarypox ALVAC-HIV vCP205 in~     combination with recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF)~     at 80 microg and 250 microg. [AS PER AMENDMENT 4/30/99: To study the safety of following 4~     ALVAC immunizations with a nucleic acid gag/pol HIV-1 immunogen (APL-400-047, Wyeth-Lederle).~     To assess the ability of this sequence of immunization to boost the LTL, T-helper cell, and~     antibody response.] ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in~     more than half of recipients in some protocols. Depending on the HIV-1 gene products~     expressed by the particular ALVAC-HIV candidate vaccine, volunteers have generated~     anti-Envelope (vCP125, vCP205, and vCP300), anti-Gag (vCP205 and vCP300), and anti-Nef~     (vCP300) CTL activity. Although 3 to 4 immunizations with the different ALVAC-HIV~     experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion, often the~     majority, of volunteers, the geometric mean titers of these antibodies are modest, usually~     less than 50. This study will determine whether there is an increase in the anti-HIV antibody~     titers when GM-CSF is used as an adjuvant with ALVAC-HIV vCP205 and will also examine the~     kinetics and magnitude of the HIV-specific CTL response.~   "
272403|NCT00001089|"~     To define relationships between 1) HIV load and risk of CMV disease, 2) CMV load and the risk~     of developing CMV disease, and 3) CMV load and HIV load. To establish threshold CMV and HIV~     load values in peripheral blood fractions that are associated with development of CMV~     end-organ disease. To define the natural history of CMV diseases in the context of highly~     active antiretroviral therapy (HAART).~      Establishment of threshold CMV and HIV load values associated with CMV disease would~     facilitate identification of HIV-infected individuals truly at risk for CMV disease in whom~     targeted prophylactic interventions to prevent CMV disease would be indicated. These studies~     would also further the understanding of the natural history of CMV disease within the context~     of AIDS. Natural history studies conducted prior to the advent of highly active~     antiretroviral therapy (HAART; i.e., 3-drug regimens that include HIV reverse transcriptase~     and protease inhibitors) have demonstrated that the risk for developing CMV disease increases~     with progression of HIV disease and with declining CD4 counts. Presently the need exists to~     define the natural history of CMV disease in patients with AIDS within the context of HAART.~   "
272404|NCT00001088|"~     To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine~     when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at~     the intermediate dose. [AS PER AMENDMENT 07/98: To evaluate the tolerability, safety, and~     immunogenicity of an increased dose in an additional group of volunteers.] DNA-based~     immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and~     cellular arms of the immune system; thus, potentially providing the advantages of a live~     virus vaccination but without the potential risks. It is essential that novel vaccine~     strategies (including DNA-based immunizations) continue to be developed and enter Phase I~     human testing because to date, no candidate vaccine from any of the approximately 30 AVEG~     Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun~     for vaccine delivery may also have potential psychological, comfort, safety and immunologic~     advantages over the traditional needle and syringe method of delivery.~   "
272405|NCT00001087|"~     Steps I and II: The purpose of this study is the following: To look at how many patients~     achieve undetectable HIV blood levels at Week 16. To look at the absolute change in HIV blood~     levels from the beginning of the study to Week 16. To look at the safety and tolerability of~     nelfinavir (NFV) and efavirenz (EFV) when used in combination or separately in regimens~     containing reverse transcriptase inhibitors (RTIs). For the 2 extension studies (Weeks 49 to~     144): To look at the proportion of patients whose long-term viral load remains undetectable~     at Week 96. To look at the time from the beginning of the study to treatment failure, with~     patients evaluated through Week 144. Step III: To look at the proportion of patients whose~     HIV blood levels are undetectable 16 weeks after starting the salvage study treatment. To~     assess safety, toxicity, and tolerance of salvage study drug treatment. (This study has been~     changed by adding new objectives.) Achieving viral suppression has been widely endorsed as~     the primary goal of HIV therapy. However, there are few established guidelines for devising~     combinations of different classes of drugs which will enhance the potential for achieving~     viral suppression, reducing the risk of toxicity, and preserving therapeutic options for~     future use. This study includes 2 anti-HIV drugs, NFV (a protease inhibitor [PI]) and EFV (a~     nonnucleoside reverse transcriptase inhibitor [NNRTI]), for use either alone or in~     combination with RTI therapy for the purpose of limiting HIV replication. Patients with~     treatment failure at Week 16 choose 1 of the following 3 alternative salvage therapies:~     2-drug PI regimen (saquinavir and ritonavir) plus adefovir dipivoxil and L-carnitine; EFV or~     NFV (if not already given) plus 2 new approved anti-HIV drugs outside the study; or the best~     available treatment outside the study. The new RTI, adefovir dipivoxil, is added to the~     2-drug PI regimen to achieve suppression of viral replication and thereby delay disease~     progression. (This rationale reflects a change in the treatment given to patients with~     treatment failure at Week 16.)~   "
272406|NCT00001086|"~     To compare the virologic response between abacavir (ABC, 1592U89) regimens (drug vs. placebo)~     and between the 2 dosing regimens (BID vs. TID) with respect to the proportion of patients~     with plasma HIV RNA levels below the limit of detection [AS PER AMENDMENT 8/27/97: < 500~     copies/ml at week 16]. To evaluate the safety and tolerance of the study arms. [AS PER~     AMENDMENT 3/10/99: During the extension period, compare the time to detectable viremia (2~     consecutive plasma HIV RNA levels greater than or equal to 500 copies/ml) between ABC and~     placebo.] Therapeutically, there is a need to explore potent alternative therapy for patients~     who have received, or are currently receiving, a double nucleoside analog combination~     including lamivudine (3TC), a regimen that was proven to be clinically inferior to indinavir~     (IDV) when combined with zidovudine/3TC in study ACTG 320. In order to produce and maintain a~     maximal antiviral response, all patients in this study will receive 2 or 3 potent, new~     agents; ABC, a nucleoside analog, EFV, a non-nucleoside reverse transcriptase inhibitor~     (NNRTI), and IDV, a protease inhibitor. Virologically, the major question this protocol seeks~     to answer is how prior 3TC exposure in a dual nucleoside regimen influences the response to~     subsequent treatment. It is unclear whether it is best to add a protease inhibitor either 1)~     an NNRTI at 1 of 2 doses, or 2) an NNRTI at 1 of 2 doses plus a new nucleoside analog to~     achieve plasma HIV RNA levels that are below the limits of detection.~   "
272407|NCT00001085|"~     To determine the proportion of patients whose plasma HIV-1 RNA level remains below a~     detectable level (less than 500/ml) after 24 weeks of study therapy with either 141W94~     monotherapy or 141W94 plus zidovudine (ZDV) and lamivudine (3TC). To determine the safety and~     tolerability of 141W94 monotherapy and the combination of 141W94 plus 3TC in patients with~     HIV infection.~      Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir~     monotherapy, in both cases maximum suppression required combination treatment together with~     nucleoside analog RT inhibitors. This study tests the hypothesis that monotherapy with 141W94~     doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein~     binding for HIV-1 can achieve the same virologic and immunologic effects in terms of~     magnitude and durability, as has been observed with combinations of other protease inhibitors~     plus nucleoside analogs.~   "
272408|NCT00001084|"~     To compare the proportion of patients who sustain suppression of plasma HIV RNA to~     undetectable levels [AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive~     assay] among the 3 regimens during the maintenance phase.~      The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic~     function and delay the development of HIV-related complications. In patients administered~     potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and~     below the level of detection of commercially available assays. This protocol attempts to~     learn if a less intensive regimen can successfully sustain viral suppression after induction~     with a triple-drug regimen. The study also addresses whether HIV can be eradicated in~     patients following prolonged treatment with induction and maintenance regimens.~   "
272409|NCT00001083|"~     For PRAM-1: To evaluate zidovudine (ZDV) + lamivudine (3TC) vs. stavudine (d4T) + ritonavir~     vs. ZDV + 3TC + ritonavir with respect to the change in plasma HIV-1 RNA copy number from~     baseline to 48 weeks [AS PER AMENDMENT 1/5/98: 72 weeks; AS PER AMENDMENT 7/17/98: 48 weeks]~     in stable HIV-infected children with >= 16 weeks of prior continuous antiretroviral therapy.~     To evaluate the safety and tolerance of ZDV + 3TC vs. d4T + ritonavir vs. ZDV + 3TC +~     ritonavir based upon laboratory and clinical toxicities.~      AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: To evaluate d4T + nevirapine + ritonavir with~     respect to change in plasma HIV-1 RNA copy number from baseline to 48 weeks in children who~     have received at least 12 weeks of therapy on the PRAM-1 ZDV/3TC arm and have over 10,000~     viral copies at weeks 12, 24, or 36. To evaluate the safety and tolerance of d4T + nevirapine~     + ritonavir based upon laboratory and clinical toxicities. [AS PER AMENDMENT 10/23/98: To~     evaluate safety and tolerance of a switch from d4T + ritonavir vs. ZDV + 3TC + ritonavir to~     d4T + indinavir vs. ZDV + 3TC + indinavir in stable, HIV-infected children with RNA values <=~     10,000 copies/ml.] For PRAM-1: Evidence supports combination therapy with 2 or more antiviral~     agents as beneficial in the long-term management of HIV. The possibility exists that~     combination therapy may result in a synergistic or additive activity over a prolonged period~     of time. Also hypothesized is that the development of resistance to individual agents will be~     developed if viral replication is significantly decreased.~      AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: Interim analysis at 12 weeks on PRAM-1~     indicates that the proportion of children reaching undetectable RNA levels on the ZDV + 3TC~     arm is significantly less than the other two arms. The protocol, therefore, has been modified~     (Step 2) to permit children in the ZDV + 3TC arm with RNA copy number >= 10,000 the~     opportunity to change to a novel therapeutic regimen (d4T + nevirapine + ritonavir).~   "
272410|NCT00001082|"~     To evaluate the safety and efficacy of adefovir dipivoxil in prolonging survival of patients~     with advanced HIV disease. In CMV prophylaxis substudy: To evaluate the efficacy of adefovir~     dipivoxil in preventing the development of CMV end-organ disease in patients with advanced~     HIV coinfected with CMV.~      The optimal treatment for HIV infection and the prevention of CMV disease has not been~     identified. Currently available antiretroviral therapies are hampered by both significant~     toxicities and the development of resistance. In addition, agents for preventing CMV disease,~     such as oral ganciclovir, are complicated by poor bioavailability and decreased compliance~     secondary to toxicities. Moreover, discordant results have been reported regarding the~     effectiveness of oral ganciclovir for preventing CMV disease. There is a need for newer~     agents with anti-HIV and anti-herpesvirus activity that have good pharmacokinetic and safety~     profiles and that will be well tolerated by patients. Adefovir dipivoxil is an oral pro-drug~     of PMEA, a nucleoside analog with activity against a broad spectrum of retroviruses and~     herpesviruses, including important human pathogens, such as HIV-1, HIV-2 and CMV. Due to its~     anti-HIV and anti-herpesvirus activity, adefovir dipivoxil may be able to decrease the~     incidence of opportunistic herpesvirus infections and prolong survival in patients with~     advanced HIV infection.~   "
272411|NCT00001081|"~     To determine the frequency of complete, marked, and partial clinical responses in patients~     with cryptosporidiosis treated with 6 weeks of NTZ versus 21 days of placebo. To determine~     the safety of NTZ in subjects with cryptosporidiosis.~      There is no proven therapy for cryptosporidiosis in persons with AIDS. Nitazoxanide appears~     to be a good candidate drug for further evaluation because of its effectiveness in~     preclinical models, the data from early clinical trials and its safety profile. Cooperation~     between clinical researchers and basic scientists in clinical trials of agents for HIV~     infection and its complications is a high priority for the ACTG, the NIAID, and the NIH.~     Thus, it is important to design a clinical trial of NTZ that includes cooperation with basic~     scientists.~   "
272412|NCT00001080|"~     To ascertain whether the origin of plasma HIV-1-RNA following T cell activation represents~     the activation of latently infected cells or an increase in cells permissive for replacing~     viral mutants.~      The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known.~     In particular, it is uncertain whether the transient increase in plasma HIV-1 RNA is due to~     enhanced replication of an actively replicating pool of HIV-1, or is due instead to~     activation of proviral sequences in previously resting CD4+ cells. One approach to~     discriminate these alternatives is a molecular pulse-chase experiment. In this approach,~     drug resistant mutants would be selected by administration of Lamivudine (3TC).~   "
272413|NCT00001079|"~     To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM)~     that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved~     by treatment with megestrol acetate and testosterone enanthate in combination.~      Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with~     HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV~     associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight~     gain in subjects with cancer and in those with HIV associated weight loss. However, the~     weight gained during treatment with megestrol acetate was predominantly or exclusively fat.~     An important factor is the preferential increase in body fat seen in both of these studies~     may have been due to hypogonadism that occurs as a result of treatment with megestrol~     acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and~     a decrease in LBM. Concomitant testosterone replacement should substantially increase the~     amount of LBM accrued during megestrol acetate therapy. This study will determine whether~     anabolic potential can be realized when caloric intake is increased in the absence of~     concomitant hypogonadism.~   "
272414|NCT00001078|"~     The purpose of this study is to find out if it is safe for HIV-positive children who are~     responding well to their anti-HIV treatment to stop taking medications that prevent~     AIDS-related infections (opportunistic infections) such as pneumonia and other bacterial~     infections. This is an observational study, meaning children will only be monitored to see if~     they develop any infections.~      Children have been receiving medications to prevent complications of HIV infection, such as~     Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC) disease, or other~     bacterial infections. It is common for HIV-positive patients with low CD4 counts to receive~     these preventive medications. However, these drugs can have serious side effects, they are~     expensive, and it is possible for bacteria resistant to the drugs to grow. For these reasons,~     it may be beneficial to the child to stop taking these preventive medications if he/she has~     been on anti-HIV (antiretroviral) therapy and has improved CD4 counts. This study will look~     at how many children who stop taking their medications develop opportunistic infections.~   "
272415|NCT00001077|"~     To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric~     supplement containing whole protein and long-chain triglycerides, and no caloric supplement~     for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and~     mineral supplement.~   "
272416|NCT00001076|"~     To evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox~     vaccine ALVAC-HIV MN120TMG (vCP205) versus control followed by boost with rgp120/HIV-1 SF2~     vaccine in HIV-negative volunteers.~      Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic~     T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can~     produce immunological responses comparable to those obtained in other trials of ALVAC-HIV~     vCP205.~   "
272417|NCT00001075|"~     To determine whether administration of a highly active antiretroviral treatment regimen~     consisting of ritonavir (ABT-538), zidovudine (AZT), and lamivudine (3TC) is associated with~     the restoration of delayed type hypersensitivity and lymphocyte proliferative responses in~     patients with moderately advanced HIV-1 infection. To better characterize in these patients~     the phenotype of the expanded lymphocyte subpopulations, as well as the genotype, phenotype,~     and cellular origin of viruses that persist after initiation of therapy, and the genotype and~     phenotype of drug-resistant isolates that emerge during therapy.~      Although plasma viral load drops dramatically after initiation of powerful antiretrovirals,~     it does not drop to zero. It appears that a new steady state is reached, suggesting that a~     reservoir may exist of virus-producing cells, possibly cells of monocyte/macrophage lineage,~     that continue to produce a low level of virus despite antiretroviral treatment.~   "
272418|NCT00001074|"~     To determine the safety and tolerability of hydroxyurea at two doses alone and in combination~     with didanosine (ddI). To compare the short term antiviral effect of ddI monotherapy versus~     hydroxyurea plus ddI, as measured by plasma RNA levels at 8 weeks of therapy. [AS PER~     AMENDMENT 10/1/97: Accrual to arms involving hydroxyurea alone has been closed.] Current~     antiviral therapies for HIV-1 are limited by a few choices, and the lack of sustained~     clinical benefit from the drugs. The mechanisms that account for the lack of prolonged~     inhibition of viral replication by these agents are not fully understood. The activity of RT~     inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient~     HIV reverse transcription. Based on this information, comparisons of the antiviral effects of~     ddI monotherapy and hydroxyurea plus ddI, with the cellular enzyme ribonucleotide reductase~     as a potential target, should be done.~   "
272419|NCT00001073|"~     The purpose of this study is to see if it is safe and effective to give isotretinoin to~     HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous.~      Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected~     women are at a greater risk, and often their tumors become cancerous more quickly than those~     in HIV-negative women. Isotretinoin may be able to prevent this from happening. However,~     since these tumors tend to disappear over time, many doctors are hesitant to give their~     patients isotretinoin since this drug causes birth defects. This study looks at whether it is~     better to treat cervical tumors in HIV-infected women or to wait and see if they will~     disappear by themselves.~   "
272420|NCT00001072|"~     To evaluate, in HIV-negative volunteers, the safety and immunogenicity of ALVAC-HIV~     MN120TMGNP (vCP300) followed by or combined with boosting using rgp120/HIV-1SF2. To compare~     ALVAC-HIV vCP300 with ALVAC-RG rabies glycoprotein (vCP65) as a control. To evaluate an~     accelerated immunization schedule at 0, 1, 3, and 6 months versus 0, 1, 6, and 9 months.~      The combination of a live recombinant primer followed by a subunit boost has the potential to~     induce not only cytotoxic T lymphocytes but also neutralizing antibody.~   "
272421|NCT00001071|"~     To determine the safety of stem cell harvesting after administration of filgrastim ( G-CSF )~     to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of~     HIV-1 infection as well as in HIV-negative volunteers. To determine the surface phenotypic~     and functional characteristics as well as the viral load in the stem cells obtained following~     this procedure.~   "
272422|NCT00001070|"~     This is a study to evaluate the tolerance and antiviral effect of oral vitamin C in~     HIV-infected.~   "
272423|NCT00001069|"~     PRIMARY: To compare the clinical efficacy of two decision making strategies for initiating or~     changing antiretroviral therapy: decision making based on current clinical practice alone~     (i.e., initiating or changing therapy based on CD4 count decline and/or clinical progression)~     versus decision making based on plasma HIV RNA quantitation in addition to current clinical~     practice.~      SECONDARY: To evaluate toxicity, biological markers, and patient management in the two arms.~      Although changing therapies is a common strategy in the treatment of HIV disease, guidelines~     are needed to help clinicians and patients decide when a change in antiretroviral therapy is~     indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for~     monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive~     antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible~     will confer clinical benefit in comparison with management based on monitoring CD4 counts and~     HIV-related symptoms.~   "
272424|NCT00001068|"~     To determine the influence of virus load, CD4 count, biologic phenotype, and presence of~     symptomatic disease on the response of HIV-infected patients to a new therapeutic regimen.~     PER AMENDMENT 8/27/96: To extend the availability of currently assigned ACTG 303 treatment~     for 6 months.~   "
272425|NCT00001067|"~     To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT~     ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes~     in magnitude of HIV RNA over time.~      Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of~     the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV~     activity in previous studies, provides an additional therapeutic option.~   "
272426|NCT00001066|"~     To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the~     better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected~     children who received less than 56 days of prior antiretroviral therapy. To evaluate the~     safety and tolerance of 3TC/AZT in this patient population. To determine other measures of~     diseases in response to the study regimens.~      Currently, none of the potential treatments for HIV-1 infection has proven to be both~     nontoxic and effective in long-term use. However, previous studies in both adults and~     children have shown that 3TC combined with AZT reduced HIV load in blood and increased white~     blood cells. Additionally, 3TC has demonstrated a favorable safety profile.~   "
272427|NCT00001065|"~     To assess response and toxicity in patients with fluconazole-resistant oral candidiasis (~     thrush ) when given initial induction with amphotericin B oral suspension.~      Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected~     patients is limited but encouraging.~   "
272428|NCT00001064|"~     To define the safety and efficacy of sibling-supplied, HIV antigen-pulsed dendritic cells in~     increasing the immune response in HIV-infected patients.~      Dendritic cells are a type of white blood cell used by the body to fight infection. They are~     instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since~     dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic~     cells from an HIV-negative sibling may enable the affected sibling's immune system to~     recognize foreign particles more readily and increase immune response against the virus.~   "
272429|NCT00001063|"~     To compare the effect of stavudine (d4T) alone or with zidovudine (AZT) versus didanosine~     (ddI) alone or with AZT on CD4 counts, HIV RNA levels, and viral load in HIV-infected~     patients [AS PER AMENDMENT 3/21/97: To compare the effects of d4T alone versus ddI alone~     versus AZT plus ddI]. To compare the safety of d4T/AZT. AS PER AMENDMENT 3/21/97: To evaluate~     the pharmacokinetic interactions of AZT and d4T both at an extracellular and intracellular~     level.~      Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these~     drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity~     profile and demonstrated activity against HIV, offers an additional therapeutic option. It is~     reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical~     disease progression is directly related to its ability to achieve and sustain viral~     suppression; thus, this study measures effects on viral load and CD4 count.~   "
272430|NCT00001062|"~     To determine whether alternating oral ganciclovir with intravenous ( IV ) ganciclovir can~     prevent relapse of Cytomegalovirus ( CMV ) retinitis and improve quality of life in AIDS~     patients.~      A systemic treatment strategy for CMV retinitis is needed that will be effective yet~     convenient to administer, without the need for a permanent indwelling IV catheter. Although~     oral ganciclovir has been used as maintenance following induction with IV ganciclovir,~     patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which~     oral and IV ganciclovir are alternated may prevent reactivation and progression of disease,~     as opposed to the current therapeutic strategy in which changes in therapy are event-driven.~     Also, the duration of intermittent IV therapy required to control disease may be short enough~     to eliminate the need for an indwelling catheter.~   "
272431|NCT00001061|"~     To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on~     time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of~     MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and~     efficacy and virologic markers.~      Therapeutic agents currently available for CMV retinitis are limited by their inherent~     toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL~     109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations~     easily maintained in AIDS patients.~   "
272432|NCT00001060|"~     To determine the safety of immunization with HIV-1 C4-V3 polyvalent peptide vaccine in~     HIV-infected persons. To determine the proportion of study participants immunized who develop~     new specificities or increased levels of neutralizing and other antibody responses, T-cell~     proliferative responses, and Class I restricted cytotoxic T-lymphocyte ( CTL ) responses.~      HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes~     from four of the most common HIV isolates in the United States and Europe, predicted to~     represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes~     that generate potentially salutary immune responses and deletes epitopes that generate immune~     responses which might contribute to further immunopathogenesis.~   "
272433|NCT00001059|"~     To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone~     or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related~     Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free~     survival and quality of life.~      Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which~     permits disease palliation at relatively low doses and thus decreases some of the~     dose-limiting toxicity. Multi-agent therapy is considered to be more effective than~     single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.~   "
272434|NCT00001058|"~     To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or~     both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons~     with AIDS, including individuals who have or have not received prior MAC prophylaxis.~      It is believed that effective therapy for MAC disease in patients with AIDS requires~     combinations of two or more antimycobacterial agents in order to overcome drug resistance and~     the unfavorable influence of the profound immunosuppression associated with AIDS. Data~     suggest that clarithromycin may have substantial activity in two- or three-drug combination~     regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.~   "
272950|NCT00018603|"~     This is a double-blind, placebo-controlled, randomized study lasting 8 weeks. Purpose of the~     study is two-fold: first, to use a pharmacological agent to treat symptoms of PTSD, and~     second, to explore neurobiological mechanisms of action of guanfacine.~   "
272435|NCT00001057|"~     To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI)~     on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients~     with CD4 counts greater than or equal to 550 cells/mm3.~      Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV~     infection, there is an extraordinarily large number of infected CD4+ lymphocytes and~     macrophages throughout the lymphoid system, both in latent and productive states. These~     findings support the belief that early intervention therapy with reverse transcriptase~     inhibitors could prolong the clinical latency period.~   "
272436|NCT00001056|"~     To determine the safety of and immune response to vaccinia-derived HIV-1 recombinant envelope~     glycoprotein (gp160) at a dose of 200 mcg in human volunteers; to evaluate duration of~     antibody response and its relationship to the dose and frequency of inoculation.~      Although recent advances have been made in antiviral therapy against AIDS, there is currently~     no cure for AIDS. It is likely that the ultimate control of the disease depends on the~     development of safe and effective vaccines against HIV.~   "
272437|NCT00001055|"~     To evaluate the safety and immunogenicity of ALVAC-HIV MN120TMG (vCP205) in comparison to~     ALVAC-RG rabies glycoprotein (vCP65) as a control when administered in HIV-1 negative~     volunteers.~      ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a~     humoral and cellular response against several antigens. This recombinant construct is based~     on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the~     transmembrane portion of the LAI strain as well as gag and protease.~   "
272438|NCT00001054|"~     To obtain tolerance, safety, and pharmacokinetic data for oral valacyclovir hydrochloride (~     256U87 ) in HIV-1 infected children with herpes simplex virus infections ( cold sores )~     and/or varicella / zoster virus infections ( chicken pox / shingles ).~      Varicella and zoster are common problems in HIV-infected children. It is believed that~     chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir,~     resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir~     in the body, increases acyclovir bioavailability by 3-5 fold.~   "
272439|NCT00001053|"~     To evaluate the safety and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles)~     vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated~     with and without alum induces CD8+ cytotoxic T lymphocytes ( CTLs ) that may be~     cross-reactive against multiple HIV-1 stains. Also, to determine whether boosting with the~     vaccine orally or rectally will help induce mucosal antibody responses.~      Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine.~     Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal~     surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV~     p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against~     HIV-1.~   "
272440|NCT00001052|"~     To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1~     (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different~     vaccination schedules.~      Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21~     on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody~     response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in~     vaccine delivery. This study compares these two delivery schedules using the unadjuvanted~     vaccine formulation rsgp120/HIV-1 with or without addition of alum.~   "
272441|NCT00001050|"~     To study the effect of pregnancy, age, drug use, and coinfections on HIV progression rate. To~     document the prevalence, incidence, characteristics, and course of HIV infection and~     anogenital intraepithelial neoplasia among HIV-positive and HIV-negative women. To study the~     effect of HIV disease on gynecologic health including infections and reproductive function.~   "
272442|NCT00001049|"~     To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in~     combination with zidovudine (AZT) in HIV-infected infants.~      PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the~     safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in~     log10 RNA, of the two study arms.~      Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and~     rapid decline of CD4 count and immunologic function. Combination therapy may be preferred~     over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is~     little information on ddI monotherapy in young infants less than 90 days and no information~     on the use of combination therapy in this population.~   "
272443|NCT00001048|"~     To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either~     didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine~     (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or~     improvement of neurological function over 6 months in HIV-infected individuals who have~     developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these~     three treatment regimens on Karnofsky score and MRI studies.~      The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus~     (designated JC virus) infection, has not been determined, although the most encouraging~     results have occurred with intrathecal administration of the drug.~   "
272444|NCT00001047|"~     To compare the safety and efficacy of two doses of clarithromycin in combination with~     ethambutol and either rifabutin or clofazimine for the treatment of disseminated~     Mycobacterium avium Complex (MAC) disease in AIDS patients.~      Recommendations have been issued for AIDS patients with disseminated MAC to be treated with~     at least two antimycobacterial agents and for every regimen to include a macrolide~     (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains~     unknown.~   "
272445|NCT00001046|"~     PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo~     administered to HIV-infected pregnant women.~      SECONDARY: To evaluate the immunogenicity and long-term safety of rgp120/HIV-1SF2 in~     HIV-infected pregnant women who received the vaccine during pregnancy only or during~     pregnancy and postpartum. To evaluate immunogenicity and safety in the infant through 18~     months of age following maternal immunization with the vaccine during pregnancy.~      Active immunization of HIV-infected women during pregnancy may slow the progression of~     maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of~     epitope-specific antibody. Also, active immunization has the potential to induce primary~     immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the~     mothers.~   "
272446|NCT00001045|"~     To validate that the alteration of codon 215 of reverse transcriptase in plasma virus~     precedes the increase in viral burden as measured in the peripheral blood and the decline in~     CD4 count that have been observed in association with clinical failure on zidovudine (AZT).~     To determine whether alternative regimens of antiretroviral agents alter the course of viral~     burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To~     obtain further data on the safety and immunologic and virologic response to~     AZT/didanosine/nevirapine.~      Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at~     codon 215 of the reverse transcriptase gene is the most commonly occurring and has the~     greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent~     further immunologic and virologic deterioration.~   "
272447|NCT00001044|"~     PRIMARY: To examine the safety and potential improvement in immune responses elicited by~     combining rsgp120/HIV-1MN with the adjuvant QS-21. SECONDARY: To examine the role of alum in~     the vaccine/adjuvant formulation; to determine the optimal dose ratio of vaccine to adjuvant;~     and to obtain initial information on the optimal schedule of administration. AS PER AMENDMENT~     07/02/97: To determine the ability of immunization with rsgp120/HV-1MN in combination with~     QS21 with or without alum to induce an HIV-1 envelope-specific delayed-type hypersensitivity~     (DTH) response in volunteers who undergo rsgp120/MN skin testing.~      Immune responses in HIV-uninfected individuals receiving subunit envelope vaccines formulated~     with alum adjuvant suggest that functional antibodies capable of neutralizing HIV-1 in vitro~     may be induced, but the titers are relatively low in comparison to those measured in~     individuals with natural HIV-1 infection. These limitations might be overcome by the addition~     or substitution of a more suitable adjuvant such as QS-21.~   "
272448|NCT00001043|"~     AMENDED 8/94: To expand the safety and immunogenicity profile of MN rgp160 vaccine~     (Immuno-AG) by administering a higher dose (800 mcg) at 0, 1, 6, and 12 months and 0, 2, 8~     and 14 months (these two schedules were compared in VEU 013A using a dose of 200 mcg). To~     obtain plasma following the fourth immunization. To evaluate skin test reactivity.~      ORIGINAL (replaced): To determine in healthy volunteers the safety and immunogenicity of two~     immunizations of MN rgp160 vaccine (Immuno-AG) in combination with a live recombinant~     vaccinia virus LAV HIV-1 gp160 vaccine (HIVAC-1e) versus DryVax (the standard smallpox~     vaccine that was used for many years) control in combination with placebo.~      ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of~     HIV-1 in the United States, has been developed. A previous study showed that a combination~     vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160~     subunit vaccine, resulted in humoral and cellular immune responses of greater and longer~     duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN~     rgp160 vaccine merits investigation.~   "
272449|NCT00001042|"~     To determine in healthy HIV-negative volunteers the safety and immunogenicity of~     rgp120/HIV-1SF2 (BIOCINE) formulated with each of seven adjuvants.~      PER AMENDMENT 3/6/96: Purpose of the extension study - To determine the ability of~     immunization with rgp 120/SF-2 to induce an HIV-1 envelope-specific delayed-type~     hypersensitivity (DTH) response in volunteers who receive rsgp 120/MN skin testing.~      One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine~     the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several~     mechanisms, and as a result induce a more favorable antibody response with high titers, which~     appear earlier in the course of immunization and persist over time.~   "
272450|NCT00001041|"~     To evaluate the safety of rgp120/HIV-1MN vaccine in HIV-1 infected pregnant women with CD4~     counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and~     the passive acquisition of vaccine-specific antibody in their infants. To evaluate the~     induction or augmentation by rgp120/HIV-1MN vaccine of mucosal immune response in the~     gastrointestinal and reproductive tracts during pregnancy. To isolate and genetically~     characterize the HIV-1 present in cervicovaginal fluid specimens of pregnant women and~     compare it to that present in their peripheral blood mononuclear cells and to that of their~     infected infants.~      Evidence suggests that an advanced stage of disease with high plasma viremia is associated~     with increased transmission of HIV-1 to the fetus. Slowing the progression of disease,~     reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody~     are potentially attainable goals through active immunization of the mother during pregnancy.~   "
272451|NCT00001040|"~     PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir~     mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC)~     vs. Ro 31-8959 plus AZT plus ddC.~      SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of~     the three regimens.~   "
272452|NCT00001039|"~     To assess the feasibility of using culture and staining techniques to quantify tissue~     Mycobacterium avium Complex (MAC) burden in bone marrow. To correlate and compare changes in~     MAC bone marrow burden with quantitative MAC blood culture results at baseline and after 4~     and 8 weeks of treatment.~      MAC is easiest to detect in the blood, although doctors generally believe that MAC in blood~     is just spill-over from infection of other parts of the body. Traditionally, studies of~     potential treatments for MAC focus only on MAC changes in the blood. This study compares MAC~     changes in blood to those in bone marrow, which is another tissue where MAC is often found.~   "
272453|NCT00001038|"~     PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention~     of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+~     lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and~     low-dose oral acyclovir on survival.~      SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug~     administered concurrently with standard antiretroviral agents and other essential therapies~     for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in~     suppressing activation of other herpesviruses. To evaluate serologic and virologic risk~     factors for the development of CMV disease, including assessment of HIV activation, and the~     risk of developing drug-resistant CMV, HSV, and VZV.~      Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in~     patients with advanced HIV disease, although there is evidence that high doses of the drug~     may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after~     oral administration, has a higher absorption rate and may therefore provide inhibitory~     activity against CMV.~   "
272454|NCT00001037|"~     To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus~     placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94~     amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth~     immunization at 9 or 11 months after the third injection (i.e., at month 17).~      A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and~     immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger~     proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a~     gp160 vaccine derived from the MN strain is important.~   "
272455|NCT00001036|"~     To determine the safety of thymosin alpha 1 given twice weekly in a regimen of daily oral~     zidovudine (AZT) and biweekly polyethylene glycolated interleukin-2 (PEG IL-2). To determine~     the effect of thymosin alpha 1 and PEG IL-2 in combination with AZT on immunologic and~     pharmacokinetic markers.~      AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1~     appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte~     maturation in vivo; thus, the drug may further enhance the CD4 T cell levels in patients~     receiving AZT and PEG IL-2.~   "
272456|NCT00001035|"~     To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with~     nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the~     efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV~     infections treated with nucleoside analog therapy.~      IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic~     hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive~     patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients~     with advanced HIV infection has not been determined.~   "
272457|NCT00001034|"~     To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against~     cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients~     with severe immunosuppression.~      The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until~     recently, both drugs required intravenous administration. An oral form of ganciclovir, if~     shown to be effective therapy against CMV, would be a more suitable method of administration~     for prophylaxis.~   "
272458|NCT00001033|"~     PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse~     after therapy between two durations of intermittent therapy (6 versus 9 months) for the~     treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity,~     survival, and development of resistance in these two regimens.~      ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the~     treatment of pulmonary TB in HIV-infected patients who are either from areas with known high~     rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be~     susceptible to commonly used anti-TB drugs.~      PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown~     to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected~     patients has not been established.~      ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used~     to treat TB has emerged. Thus, the need to test regimens containing a new drug exists.~     Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs~     to be determined.~   "
272459|NCT00001032|"~     PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and~     zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated~     children.~      SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and~     laboratory markers of disease progression, as determined by virologic and immunologic~     determinations. To evaluate the influence of combination therapy on disease progression as~     determined by evaluation of clinical criteria.~      In children currently being treated with AZT, it is unknown whether the addition of another~     antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will~     examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT~     alone.~   "
272460|NCT00001031|"~     To evaluate the safety and immunogenicity of SF-2 rgp120 vaccine in MF59 versus MN rgp120~     vaccine in alum in volunteers who are seronegative for HIV-1. AS PER AMENDMENT 07/02/97: To~     determine the ability of immunization with MN rgp120/HIV-1 in combination with alum or SF-2~     rgp120 in combination with MF59 to induce an HIV-1 envelope-specific delayed-type~     hypersensitivity (DTH) response in volunteers who receive rsgp120/MN skin testing.~      The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to~     isolate. Thus, the identification of an immunogen that can elicit broadly neutralizing~     antibodies to HIV-1 is a major challenge in AIDS vaccine development. Two candidate vaccines,~     recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1, have shown~     immunogenicity and good tolerance in healthy immunocompetent adults. This study will expand~     testing into a larger population base, particularly targeting individuals at high risk for~     HIV infection.~   "
272461|NCT00001030|"~     To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the~     two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC)~     bacteremia or disseminated MAC disease. To compare other parameters such as survival,~     toxicity, and quality of life among the three treatment arms. To obtain information on the~     incidence and clinical grade of targeted gynecologic conditions.~      Persons with advanced stages of HIV are considered to be at particular risk for developing~     disseminated MAC disease. The development of an effective regimen for the prevention of~     disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly~     the mortality associated with this disease and its treatment.~   "
272462|NCT00001029|"~     To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of~     zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT~     alternating monthly with ddI as measured by differences in survival among HIV-infected~     persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count~     greater than or equal to 50 cells/mm3.~      Combining two nucleoside drugs has the theoretical advantage of optimal protection against~     the evolution of resistant strains of HIV. However, one major problem with combination~     nucleoside therapy in patients with advanced disease is the increased toxicity resulting from~     such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits~     of combination therapy is to alternate the two drugs.~   "
272463|NCT00001028|"~     To compare the safety and efficacy of aerosolized pentamidine and dapsone in the prevention~     of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients who are intolerant~     to trimethoprim and/or sulfonamides.~      Both aerosolized pentamidine and dapsone have been shown to prevent PCP, but both drugs cause~     side effects. This study attempts to determine which drug is more efficacious as prophylaxis~     against PCP in patients who cannot tolerate trimethoprim/sulfamethoxazole.~   "
272464|NCT00001027|"~     Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous~     pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are~     intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of~     these regimens in this patient population.~      Secondary: To obtain information on the rate of PCP breakthrough in infants and children~     receiving parenteral pentamidine prophylaxis.~      Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected~     children considered to be at high risk. In children younger than 5 years of age with~     intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful~     alternative.~   "
272465|NCT00001026|"~     Primary: To determine whether combination vaccination, i.e., priming with a vaccinia~     recombinant-containing HIV envelope (HIVAC-1e) followed by boosting with a recombinant~     subunit envelope protein (gp160 or gp120), provides enhanced immunogenicity compared to~     subunit vaccination with the individual recombinant envelope proteins only. To compare the~     relative immunogenicity of a panel of HIV envelope subunit vaccines when administered as~     boosters following recombinant HIV-vaccinia priming. To evaluate the relative immunogenicity~     of one versus two doses of recombinant HIV-vaccinia prior to the subunit protein boost.~      Secondary: To examine the safety of administering the individual subunit vaccines in~     combination with the HIV envelope vaccinia recombinant, and to extend the population to whom~     these proteins have been administered.~      Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting~     with subunit envelope proteins offers the most promising strategy to date for a safe and~     immunogenic vaccine in humans. This study will further examine the combination vaccine~     approach and define an optimal prime-boost strategy.~   "
272466|NCT00001025|"~     To determine the relationship of viral susceptibility to zidovudine (AZT) and baseline viral~     load (as determined by plasma viremia and quantitative endpoint dilution). To determine the~     relationship between viral load and susceptibility during different antiretroviral therapy~     strategies. To correlate measures of viral load and short term clinical and laboratory~     markers (such as weight, CD4 count, p24 antigenemia, and beta2 microglobulin) on the~     different therapy arms.~      High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent~     of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical~     significance of in vitro AZT resistance, it is necessary to distinguish between clinical~     failure caused by AZT resistance and clinical decompensation caused by other factors.~   "
272467|NCT00001024|"~     Immunopathogenesis objectives: To compare and quantitatively determine HIV burden and HIV~     replication in peripheral blood (PB) and lymphoid tissue (LT). To determine the degree to~     which antiretroviral therapy alters HIV replication in LT.~      Clinical objectives: To gain insight into the degree of correlation between immunologic~     surrogate markers for HIV disease (e.g., CD4, beta-2 microglobulin) as compared to measures~     of HIV replication in PB and LT. To assess changes in PB and LT viral burden after~     antiretroviral therapy and to determine its ability to predict an antiviral response.~      One of the major problems in defining the immunopathogenic changes in HIV infections has been~     the inability to correlate the extent of loss of immunologic function with the number of~     HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden~     in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount~     of HIV virus or markers for the virus in the body's lymph tissue is a better measure of~     disease progression than the amount of virus or markers for the virus in the blood.~   "
272468|NCT00001023|"~     PER 03/10/94 AMENDMENT: PART B. To determine whether there is an effect on plasma drug levels~     of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve~     (AUC) when these drugs are taken concomitantly.~      ORIGINAL PRIMARY: To gain preliminary information about the safety and tolerance of~     clarithromycin and azithromycin in combination with rifabutin (three potential agents against~     Mycobacterium avium-intracellulare) in HIV-infected patients with CD4 counts < 200 cells/mm3.~      ORIGINAL SECONDARY: To determine whether there is an effect on the pharmacokinetics of the~     macrolide antibiotics or rifabutin when these drugs are taken concomitantly. To monitor the~     effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP~     prophylaxis. To monitor the effect of macrolide/rifabutin combination therapies on AZT or ddI~     serum levels.~      Two new macrolide antibiotics, clarithromycin and azithromycin, and rifabutin (a rifamycin~     derivative) have all demonstrated in vitro and in vivo activity against Mycobacterium~     avium-intracellulare, a common systemic bacterial infection complicating AIDS. Further~     information is needed, however, regarding the clinical and pharmacokinetic interaction of~     these drugs used in combination.~   "
272469|NCT00001022|"~     Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine~     ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the occurrence of~     AIDS-related conditions in HIV-infected patients.~      Secondary: To compare the frequency and severity of adverse experiences in the three~     regimens. To compare the mortality rates in the three regimens. To compare the effects of~     antiretroviral regimens on CD4+ cell levels.~      Studies have indicated that maintenance therapy with AZT over extended periods may be limited~     by dose-dependent toxicity, primarily myelosuppression, and by the emergence of~     drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or~     ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of~     development of drug-resistant strains, than AZT alone.~   "
272497|NCT00000994|"~     To determine whether taking zidovudine (AZT) will change the natural course of HIV infection~     in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a~     similar dose but at different intervals will reduce toxicity in a more manageable treatment~     plan.~      Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent.~     AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will~     show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether~     AZT therapy will delay the development of opportunistic infections and/or KS lesions.~   "
272470|NCT00001021|"~     AMENDED 10/1/93: To evaluate the influence of prior immunization with an rgp120 vaccine on~     immune response to a subsequent immunization with a different strain of rgp120 (VEU 009X~     extension - in patients previously enrolled on VEU 009).~      ORIGINAL DESIGN: To evaluate the clinical and immunologic safety of MN rgp120/HIV-1 vaccine~     (MN rgp120 vaccine) given alone or concurrently with the IIIB rgp120/HIV-1 vaccine (IIIB~     rgp120 vaccine) in healthy HIV-1 seronegative adult subjects. To compare the immune response~     to MN rgp120 vaccine given at 100, 300, or 600 mcg. To determine the immune response to 300~     mcg MN rgp120 vaccine and 300 mcg IIIB rgp120 vaccine given concurrently.~      Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary~     infection. MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA~     technology. Because the two vaccines are derived from distinct HIV-1 strains, they may elicit~     some immunologic responses that differ. Unlike IIIB rgp120 vaccine, the MN rgp120 vaccine has~     not yet been evaluated in humans, although it is expected that the MN type will result in~     similar safety and immunogenicity as the IIIB type.~   "
272471|NCT00001020|"~     AMENDED 11/17/93: To determine whether the pattern of response to MN rgp120 vaccine is~     altered by pre-exposure to IIIB rgp120.~      ORIGINAL DESIGN: To evaluate the safety (clinical and immunologic) of rgp120/HIV-1IIIB~     vaccine (gp120 vaccine) immunization in healthy HIV-1 seronegative adult subjects. To compare~     the immune response to 100 mcg gp120 vaccine versus 300 mcg gp120 vaccine. To determine~     whether gp120 vaccine immunization causes a significant immune response as defined by~     specific parameters (e.g., induction of neutralizing antibodies to the IIIB isolate of HIV-1,~     gp120 antigen-specific lymphocytic proliferation).~      Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a~     vaccine against HIV-1 infection. The gp120 envelope protein may be produced by recombinant~     DNA technology, and studies have shown that the vaccine is capable of eliciting neutralizing~     antibody activity in both rodents and nonhuman primate species.~   "
272472|NCT00001019|"~     Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59~     emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months.~      Part B: To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five~     monthly injections.~      One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is~     manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed~     against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of~     cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines,~     may evoke relatively weak immune responses, the use of adjuvants, or substances that augment~     immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator~     MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected~     for studies with the gp120 vaccine.~   "
272473|NCT00001018|"~     To determine the pharmacokinetic profile of single doses of letrazuril in patients with~     AIDS-related cryptosporidial diarrhea; to determine the dose proportionality of single~     escalating doses of letrazuril; to determine steady-state concentrations of letrazuril; to~     evaluate the safety and efficacy of escalating doses of letrazuril, compared with placebo,~     for patients with AIDS-related cryptosporidial diarrhea.~      Letrazuril, the p-fluor analog of diclazuril, has been shown in an animal model to prevent~     infections by organisms closely related to the intracellular parasite Cryptosporidium.~     Reliable data are needed to show the effectiveness of letrazuril in treating AIDS-related~     cryptosporidial diarrhea.~   "
272474|NCT00001017|"~     To compare the safety and effectiveness of a new drug, fluconazole, with that of the usual~     therapy, amphotericin B, in the prevention of a relapse of cryptococcal meningitis (CM) in~     patients with AIDS who have been successfully treated for acute CM in the last 6 months.~      Cryptococcal meningitis is a life-threatening infectious complication of AIDS. Because~     relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with~     intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always~     effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an~     antifungal agent that can be given orally and has been shown to be effective against~     cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the~     side effects experienced by over 2000 patients or volunteers given fluconazole have seldom~     been severe enough to require withdrawal of the drug.~   "
272475|NCT00001016|"~     To determine the safety and effectiveness of an investigational drug trimetrexate (TMTX) with~     leucovorin rescue (LCV) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients~     who have AIDS, are HIV positive, or are at high risk for HIV infection, and who have~     demonstrated serious adverse effects from the conventional therapies for PCP.~      The drugs usually used to treat PCP in AIDS patients (trimethoprim / sulfamethoxazole and~     pentamidine) have had to be discontinued in many patients because of severe adverse effects.~     Currently there are no proven alternatives to these drugs. TMTX was chosen for this trial~     because it has been found to be very active against the PCP organism in laboratory tests. In~     a preliminary trial, TMTX in combination with LCV has been effective against PCP with fewer~     and less severe adverse effects.~   "
272476|NCT00001015|"~     To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious~     side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect~     different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS~     virus (HIV) or number of T cells in the patient's blood.~      RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with~     little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was~     well tolerated and safe, and this favorable result suggested that RBV should be more~     extensively studied in patients with AIDS and advanced AIDS related complex (ARC).~   "
272477|NCT00001014|"~     To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus~     leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the~     treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have~     AIDS, are HIV positive, or are at high risk for HIV infection. New treatments are needed to~     reduce the mortality rate from PCP in AIDS patients and to reduce the high relapse rate found~     after conventional therapy. Trimetrexate (TMTX) was chosen for this trial because it was~     found to be much more potent than sulfamethoxazole/trimethoprim (SMX/TMP) against the PCP~     organism in laboratory tests. Also TMTX, in combination with leucovorin (LCV), did not cause~     severe toxicity in a preliminary trial. It is believed that TMTX will be more effective in~     treating PCP and in preventing a recurrence of PCP.~   "
272479|NCT00001012|"~     To study the tolerance and safety of increasing doses of AL-721 in patients with persistent~     generalized lymphadenopathy (PGL) and symptomatic HIV infection, and to obtain preliminary~     information on the effectiveness of AL-721 against the human immunodeficiency virus (HIV) in~     HIV-infected persons with PGL and symptomatic HIV infection. Although zidovudine (AZT)~     prolongs life in certain AIDS patients, it is not a cure for AIDS and it also has toxic~     effects in many patients. Therefore, it is necessary to test other drugs in HIV-infected~     patients. AL-721 is a mixture of lipids (fats) extracted from egg yolks. Laboratory tests~     suggest that it might inhibit the infectivity of the HIV. AL-721 has been tried so far in a~     few patients for short periods of time and has been found to be well tolerated.~   "
272480|NCT00001011|"~     To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with~     early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to~     suppress HIV, to improve body defenses, and to prevent the occurrence or development of AIDS~     or advanced ARC is being evaluated.~      In one human study, patients with AIDS or advanced ARC who received AZT had fewer~     life-threatening infections, improved in weight and performance, and lived longer than~     patients who received a placebo (inactive medication). Further studies are needed because~     toxic effects associated with the use of AZT were noted and the long-term effectiveness and~     toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less~     severe HIV infections such as early ARC or PGL.~   "
272481|NCT00001010|"~     To compare the effect of zidovudine (AZT) given alone with the combination of AZT and~     acyclovir (ACV) on the human immunodeficiency virus (HIV) in persons infected with HIV, and~     to study the pharmacokinetics (how fast AZT reaches certain levels in blood and how long it~     remains), safety, and effectiveness of AZT given alone and in combination with ACV in~     treating HIV-infected patients. Other studies have shown that AZT offers potential benefits~     to specific AIDS patients when given over long time periods, and experiments in vitro (in the~     test tube) suggest that ACV may stimulate the action of AZT against HIV. It is necessary to~     obtain information on how these drugs perform in HIV-infected humans.~   "
272482|NCT00001009|"~     To determine the effectiveness and safety of dextran sulfate (DS) as a treatment for patients~     with AIDS, AIDS related complex (ARC), or asymptomatic HIV infection with or without~     persistent generalized lymphadenopathy (PGL), and to determine antiviral activity at~     different doses of DS. Although zidovudine (AZT) has shown promise in prolonging life in~     patients with AIDS and severe ARC, it has significant blood toxicities. It would be~     beneficial to combine AZT with another antiviral agent that does not have the same toxicity.~     DS might be a suitable drug since it has shown antiviral activity against HIV in the~     laboratory, and in preliminary studies it has shown little toxicity. Also, the combination of~     DS with AZT has been shown to be more effective than either alone.~   "
272483|NCT00001008|"~     To determine if methadone treatment will affect the blood levels of zidovudine (AZT) in~     patients with AIDS or AIDS-related complex (ARC) who are receiving oral AZT and methadone~     therapy. In addition, the blood levels of methadone both before and during AZT treatment will~     be studied, and patients receiving daily oral methadone treatment will be evaluated for signs~     of narcotic withdrawal during treatment with AZT.~      The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide~     approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very~     likely that an increasingly larger number of AIDS patients receiving AZT therapy will have~     had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily~     methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large~     number of patients who will undergo long-term treatment with both methadone and AZT.~     Therefore, the study of potential drug interactions is essential.~   "
272484|NCT00001007|"~     To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children~     aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the~     correct dose of AZT for young children. Of a total of 908 pediatric AIDS cases, 78 percent~     have acquired HIV infection from a mother with HIV infection or at high risk for acquisition~     of HIV, and the number of cases in children is expected to increase over the next several~     years. AZT therapy may be effective in altering the course of the disease and decreasing the~     high mortality in these children. It is also possible that early intervention with AZT may~     prevent the establishment of HIV contracted before, during, or just after birth.~   "
272485|NCT00001006|"~     To determine the toxic effects of AS-101 at various doses in patients with AIDS or AIDS~     related complex. Also to determine the effect of various doses of AS-101 on immune functions~     and the occurrence of infections in these patients. AIDS is a viral disease that is~     characterized by a loss of some immune function and the development of frequent, eventually~     fatal, infectious diseases. Although zidovudine (AZT) has prolonged survival in some patients~     with AIDS, AZT is quite toxic and there is a need for more effective and less toxic drugs.~     AS-101 is a synthetic organic compound containing the metal tellurium that is being tested~     because in laboratory studies it improved immune functions.~   "
272486|NCT00001005|"~     AMENDED: To investigate whether subcutaneous (SC) injection of IL-2 produces biological~     responses which parallel those observed with IV dosing. Original design: To evaluate the~     short-term effects of combined administration of zidovudine (AZT) and increasing doses of~     recombinant interleukin-2 (aldesleukin; IL-2) in patients infected with HIV, who have~     lymphadenopathy, but who are otherwise asymptomatic (no other symptoms). The first phase of~     this clinical trial will establish maximum tolerated dose ( MTD ). How quickly the drugs get~     into the blood and how long they remain there (pharmacokinetics) will also be studied at each~     dose as well as the effect on HIV.~      Since AZT has no effect on cells that contain inactive virus (latently infected cells) and~     these cells may act as viral reservoirs, that a second agent that can destroy these infected~     cells would be useful in combination with AZT. The different activities of AZT and IL-2, as~     well as the non-overlapping nature of their mechanisms of action and toxicity, increase the~     theoretical benefits of combining AZT, a drug which has clinically significant activity in~     HIV-related disease but cannot eliminate infected cells, with IL-2, a drug which may enhance~     anti-HIV immunity, destroy chronically infected cells, and allow immune recognition of~     latently infected cells.~   "
273062|NCT00015132|"~     The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the use of~     tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified~     placebo-controlled experimental design.~   "
272487|NCT00001004|"~     To study the tolerance and toxicity of the combination of tumor necrosis factor (TNF) and~     interferon gamma (IFN-G) or as single agent TNF or IFN-G in HIV infected patients. To~     selectively monitor the immune system of AIDS related complex (ARC) patients who receive~     either combination therapy or TNF or IFN-G alone. To obtain information on the effectiveness~     of combination therapy or TNF or IFN-G alone against HIV in ARC patients.~      Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which~     causes AIDS and ARC in some laboratory studies, but may increase virus replication in other~     laboratory studies. Previous studies in humans showed no increase in virus cultures and some~     decrease in measurements of virus. Extensive preclinical data show that TNF and IFN-G are~     more effective together than separately in laboratory and animal studies. As single agents,~     both TNF and IFN-G have modest effect against HIV. Studies have demonstrated that TNF and~     IFN-G, in combination, can not only inhibit HIV infection of previously uninfected cells, but~     also can selectively induce the destruction of acutely infected target cells.~   "
272488|NCT00001003|"~     To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with~     advanced HIV disease and T4 cell count < 200 cells/mm3. To establish the range of pentamidine~     (PEN) deposition in AIDS patients participating in ACTG 021 and ACTG 081. To identify factors~     (breathing pattern, pulmonary function) that may be important in affecting the actual dose~     delivered to a given patient.~      The specific system that is used to deliver PEN to the lungs may determine whether a~     therapeutically effective dose is attained in the lungs. Therefore, this study will establish~     the amount of PEN that is deposited in the lungs of patients enrolled in protocols ACTG 021~     and ACTG 081, who are being treated with PEN administered from the Marquest Respirgard II~     nebulizer.~   "
272489|NCT00001002|"~     To study the toxicity, pharmacokinetics, and antiretroviral effectiveness of combined oral~     zidovudine (AZT) and intermittent intravenous foscarnet therapy in stable AIDS or AIDS~     related complex (ARC) patients who have already received AZT for 8 - 52 weeks.~      It is hypothesized that the maximum AZT antiretroviral effect, which occurs at 8 weeks of~     therapy, will be enhanced by 2 weeks of foscarnet treatment, given at the same time by~     intermittent intravenous infusion. In addition, the further lowering of serum p24 antigen~     concentration that should occur during combined therapy might continue when oral AZT therapy~     is continued without foscarnet.~   "
272490|NCT00001001|"~     To examine the pharmacokinetics (blood levels) and bioavailability of zidovudine (AZT) given~     to patients with HIV infection and chronic liver disease. The specific aim of the study is to~     provide data permitting the development of guidelines for use of AZT in patients with mild,~     moderate, or severe liver disease.~      AZT is the only antiviral agent that has been shown to be effective in patients with severe~     HIV infection. However, AZT is largely eliminated from the body through a biochemical~     reaction that takes place in the liver, and it is possible that patients with underlying~     liver disease may have altered AZT pharmacokinetics and may metabolize AZT differently, with~     the result that they are susceptible to an increased risk of serious drug toxicity. This~     study will examine the pharmacokinetics, elimination, and metabolism of AZT in patients with~     liver disease. Guidelines developed from the data will be helpful in managing AZT treatment~     of these HIV-infected persons and will indicate whether the dose of AZT administered should~     be adjusted to compensate for any changes in its bioavailability and/or pharmacokinetics.~   "
272491|NCT00001000|"~     To evaluate the degree and sequence of immunologic enhancement and the cellular resistance to~     certain infections after a single dose of atvogen (ampligen). In addition, the relationship~     between activation of immune cells and biochemical markers of that activation will be~     studied.~      Treatment of patients with HIV infection must address both the primary viral infection and~     the subsequent immune deficiency, which is the primary cause of mortality in AIDS. In vitro~     studies of ampligen have shown it will inhibit HIV infection. Ampligen may also minimize the~     toxicity of many drugs used in the treatment of AIDS and induce an antiviral state in the~     brain that may be useful in treating neurologic symptoms of HIV infection. The time course~     and degree of immunologic response to ampligen remain unknown although they are essential for~     proper use of the drug in the treatment of HIV infection and perhaps other clinical problems.~   "
272492|NCT00000999|"~     To obtain information about the long-term safety and toxicity of zidovudine (AZT). To~     ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT~     toxicity.~      Because of the high incidence of toxicity and the relatively short-term follow-up of the~     patients due to the early ending of the Phase II placebo-controlled experiment, it is~     valuable to continue to get information on the long-term toxicity of AZT.~   "
272493|NCT00000998|"~     To evaluate the safety and effectiveness of trimetrexate (TMTX) given at increasing doses~     along with the leucovorin calcium (LCV) for treating Pneumocystis carinii pneumonia (PCP) in~     AIDS patients TMTX is an experimental new drug which is effective for treatment of PCP, but~     has been given to only a few patients. Therefore it is not certain if TMTX is better, the~     same as, or not as effective as conventional drugs against PCP.~   "
272494|NCT00000997|"~     To determine how much of a dose is absorbed by the body when zalcitabine ( dideoxycytidine;~     ddC ) is given orally and how long the drug stays in the body after absorption or intravenous~     (IV) administration.~      Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test~     tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug~     and how long the drug remains in the body at each of six doses. This should be useful~     background information and should allow a simple and efficient comparative study of any new~     oral formulation, such as a tablet or capsule, since dose-related problems will already be~     known.~   "
272495|NCT00000996|"~     To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness~     and safety of weekly administration of small doses of doxorubicin.~      Doxorubicin is one of the most active of all antitumor agents but at currently used doses~     toxicity is common. When small doses are administered on a weekly schedule, the toxicity of~     the drug appears to be reduced.~   "
272496|NCT00000995|"~     To evaluate the clinical and laboratory toxicity of ganciclovir (GCV) and zidovudine (AZT)~     when given in combination.~      Because recent information has shown AZT to be useful in treating AIDS, it is assumed that~     most patients with AIDS, and probably with AIDS related complex (ARC), will be receiving AZT.~     Because AZT is reported not to be active against cytomegalovirus (CMV), it is important to~     see if it is useful to give GCV along with AZT.~   "
272498|NCT00000993|"~     To prevent individuals who have had a massive accidental exposure to HIV from becoming~     infected with HIV and possibly developing AIDS, by treating them with zidovudine (AZT).~     Although the number of persons who have been (or will be) exposed to a high concentration of~     HIV is quite small, these persons have a high risk of becoming infected and treatments are~     needed to prevent infection after such an exposure. In animal studies, AZT has prevented the~     development of infections after exposure of the animals to a retrovirus (the HIV is a~     retrovirus). In patients with AIDS, AZT has been effective in delaying the progression of the~     disease. For these reasons a trial of AZT is indicated.~   "
272499|NCT00000992|"~     To test the effectiveness of itraconazole in preventing the recurrence of disseminated~     histoplasmosis in AIDS patients.~      Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has~     been used to treat the infection. Although the response to this treatment is generally good,~     up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis~     infection will have a relapse (that is, they will get the disease again) within 12 months~     following treatment. Ketoconazole has been used to prevent relapse, but available information~     suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A~     more effective therapy to prevent recurrence is needed. Itraconazole has been used~     successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that~     it may be more effective in preventing histoplasmosis relapse.~   "
272500|NCT00000991|"~     To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with~     HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8~     weeks of therapy on 081 will be offered the opportunity to participate in the nested study~     (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole)~     for the prevention of serious fungal disease.~      Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial~     pneumonia, and other serious infections. It is therefore important to find drugs that can be~     given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been~     shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both~     sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective~     preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and~     extrapulmonary pneumocystosis.~   "
272501|NCT00000990|"~     To determine the safety and usefulness of zidovudine (AZT) for the treatment of children 3~     months to 12 years of age. This study is designed to determine if children who are infected~     with HIV and who have a special type of lung disease called lymphocytic interstitial~     pneumonitis (LIP) or other early symptoms of HIV infection may derive benefit from treatment~     with AZT. It is hoped that this drug will prevent children from developing additional~     symptoms and infections and will help resolve already existing symptoms.~      AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been~     shown to decrease the mortality and the frequency of opportunistic infections in certain~     adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic~     HIV-infected children may also benefit from specific antiviral therapy.~   "
272502|NCT00000989|"~     AMENDED: To evaluate the effect of sargramostim ( GM-CSF ) on modulating the granulocytopenia~     associated with concomitant DHPG and AZT therapy ( Phase B ), in terms of time to development~     of granulocytopenia as defined by an absolute neutrophil count ( ANC ) less than or equal to~     750 cells/mm3.~      Original design: To determine if granulocyte-macrophage colony-stimulating factor ( GM-CSF )~     is helpful in preventing the decreased numbers of white blood cells (infection-fighting~     cells) associated with ganciclovir ( DHPG ) therapy and to determine if GM-CSF can be safely~     used in AIDS patients with cytomegalovirus ( CMV ) retinitis.~      AMENDED: In ACTG 004, among 11 AIDS patients with CMV infection receiving DHPG maintenance~     therapy (5 mg/kg, 5x/week) with stable white blood cells (WBC)/absolute neutrophil counts~     (ANC) 7 (64 percent) required dose reduction or discontinuation of both antiviral medications~     due to granulocytopenia when AZT (600 mg/day) was added. A mean nadir ANC of 717 cells/ml was~     reached at a mean of 5 weeks of concomitant DHPG/AZT therapy in these patients. While~     recovery of depressed ANC occurred following discontinuation of study medications,~     progressive CMV infection (most commonly retinitis) occurred in 19 of 40 patients and seemed~     to be associated with DHPG therapy interruption. Only 3 of 40 patients were able to tolerate~     the complete 16 week study duration of DHPG/AZT. Pharmacokinetic studies of co-administration~     of DHPG and AZT revealed no significant drug-drug interactions. The study investigators~     concluded that the main, treatment limiting toxicity of combination DHPG/AZT therapy is~     granulocytopenia and that many patients treated on this study developed intercurrent OIs or~     staphylococcal septicemia. In order to determine whether patients receiving maintenance DHPG~     therapy with or without GM-CSF can tolerate concomitant AZT therapy, extended maintenance~     therapy with the assigned study regimen in combination with AZT will be incorporated into~     this protocol. Original design: CMV infection causes inflammation of the retina and can lead~     to permanent blindness. Treatment for CMV retinitis with DHPG has been shown to be effective~     in halting the progression of retinal disease. During DHPG treatment, however, about 30 to 55~     percent of patients develop decreased white blood cell counts. GM-CSF, a naturally occurring~     human hormone, stimulates the body's bone marrow to produce more white blood cells. Studies~     with GM-CSF in AIDS patients have shown that it can significantly increase depressed white~     blood cell counts in these patients.~   "
272503|NCT00000988|"~     To evaluate the safety, minimum effective dose (MED), pharmacokinetics and efficacy of orally~     administered 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) in patients with AIDS or AIDS~     related complex (ARC). To establish an appropriate dosage regimen of d4T to be employed in~     Phase II and III trials. To evaluate the effects of de-escalating doses of d4T on markers~     associated with HIV infection.~      Currently, the only FDA-approved therapy for patients with AIDS or ARC is zidovudine (AZT), a~     drug with significant value but limited use because of toxic effects on the bone marrow. d4T~     has not been tested in humans, but it has inhibited the reproduction of HIV (the virus that~     causes AIDS) in laboratory experiments. In some studies with laboratory animals, d4T was less~     toxic against blood cells than AZT.~   "
272504|NCT00000987|"~     To study the safety and maximum tolerated dose (MTD) of combined chemotherapy when it is~     administered to patients with advanced Kaposi's sarcoma together with one of two different~     doses of zidovudine (AZT).~      The combination of AZT and chemotherapy may be effective in treating the tumor as well as~     preventing the life-threatening infections when used for patients with AIDS and Kaposi's~     sarcoma. The MTD of combined chemotherapy is being determined so that the information will be~     available for future studies, when the relative effectiveness of the two doses of AZT has~     been learned.~   "
272530|NCT00000961|"~     To determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin~     (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary~     evidence for the effectiveness of this type of treatment in preventing the advance of disease~     in HIV infected infants. HIVIG may be an effective agent that either alone or in combination~     with AZT will prevent progression of clinical disease.~   "
273063|NCT00015106|"~     The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the treatment~     of cocaine dependence using reserpine, gabapentin, or lamotrigine vs. an unmatched placebo~     control.~   "
272505|NCT00000986|"~     To test the safety and tolerance of three different doses of recombinant human interleukin 2~     (aldesleukin; IL-2), when it is given for five consecutive days to patients with AIDS or AIDS~     related complex (ARC), who have also received zidovudine (AZT) for at least 6 weeks just~     before beginning the IL-2 treatment.~      AZT is an antiviral drug, which has been shown to be beneficial in some patients with AIDS.~     IL-2 is a substance found naturally in the body that boosts the body's immune response to~     invading organisms and tumor cells. These two drugs, when administered together, may have a~     mutually helpful effect in treating AIDS patients, but before this effect can be studied, it~     is important to understand the proper dose and any side effects that may occur when these~     drugs are used together. The study will show how much AZT and IL-2 patients can safely take~     at the same time and how the two drugs will interact with each other.~   "
272506|NCT00000985|"~     To compare the safety and effectiveness of foscarnet and vidarabine treatments for AIDS~     patients who have herpes simplex virus infections that are resistant to standard treatment~     with acyclovir.~      Foscarnet is a drug that inhibits viruses and has been shown to be effective against~     infection with Cytomegalovirus and also against infection with the Herpes simplex virus in~     several patients with AIDS. Vidarabine has been shown to have activity against the Herpes~     simplex virus in patients who do not have AIDS, but it has not been studied in patients who~     do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who~     have herpes simplex infection that has not responded to therapy with acyclovir in the hope~     that one of these two drugs will help to stop further progression of the herpes simplex~     infection and may have fewer side effects.~   "
272507|NCT00000984|"~     AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled. Original design: To~     determine whether the experimental drug recombinant CD4 (rCD4), which is produced through~     genetic engineering technology, is safe and well-tolerated in children infected with or at~     risk for HIV infection.~      rCD4 may be an effective treatment for HIV infection, based on its ability to block infection~     of human cells by HIV in laboratory tests. However, the activity of rCD4 still needs to be~     confirmed in clinical trials. It is hoped that these tests will show that rCD4 is both safe~     and effective in treating children who are infected with or who are at risk for infection~     with HIV.~   "
272508|NCT00000983|"~     To evaluate and compare differences in tolerance and side effects associated with two~     different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other~     goals are to evaluate and compare the degree of change in neurodevelopmental disease and~     determine whether there are differences in the rate and degree of toxicities associated with~     one versus the other dosage.~      AZT has been shown to decrease the death rate and frequency of opportunistic infections in~     certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic~     HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics~     (blood levels) in children have indicated that AZT can be given to children in doses that can~     be tolerated and that can be assumed to be therapeutic. Those currently taking care of~     infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance)~     trial. In addition, given the information learned from studies of adult patients that shows~     effectiveness of AZT at lower doses, experience with an equivalent lower dose in children~     needs to be studied.~   "
272509|NCT00000982|"~     AMENDED 07/07/93: To evaluate whether continuous infusion AZT will impact neurodevelopmental~     deficits associated with HIV infection or alter rate of encephalopathy progression in~     children who have failed to improve or shown progression of these deficits despite optimal~     AZT therapy.~      AMENDED: To assess whether didanosine (ddI) will be better tolerated than AZT administered by~     either continuous intravenous delivery or oral administration (ddI arm removed per amended~     version).To determine whether ddI will achieve comparable clinical efficacy as the continuous~     intravenous route of delivery of AZT, and to assess whether either or both of these regimens~     are superior to that achieved with an intermittent AZT dosage schedule. To determine whether~     there are differences in patient or parent (guardian) compliance between the three treatment~     regimens. Original design: To determine whether the pharmacokinetic profile (bloodstream~     levels) of zidovudine (AZT) influences its effectiveness on HIV infection in children. That~     is, the study seeks to find out whether there is a difference in the effect of AZT when given~     as a continuous intravenous infusion (and, if available, an oral sustained release dose)~     compared to an intermittent (not continuous) dose given orally every 6 hours. The study also~     plans to determine (1) whether there are differences in the tolerance and side effects~     associated with AZT when given on an intermittent schedule as opposed to a steady-state~     schedule; (2) the extent of variation from patient to patient in AZT levels and whether the~     plasma and cerebrospinal fluid levels of AZT are related to the degree of therapeutic~     effectiveness; and (3) whether there are differences in the response of children who acquired~     HIV infection perinatally (just before, during, or just after the time of birth) versus those~     who acquired HIV infection by transfusion.~      One of the most serious effects of HIV disease in children is neuropsychological~     deterioration (relating to mental and nervous system functioning). This complication affects~     the vast majority of HIV infected children. A previous study of continuous intravenous~     administration of AZT in pediatric patients with HIV infection showed consistent and dramatic~     improvements of symptoms in all patients that had shown neurodevelopmental deficits or~     abnormalities. These improvements were seen within 3 to 4 weeks after AZT treatment was~     started. Neurodevelopmental improvements have been sustained on AZT, usually showing steady~     improvement which, in some patients, was associated with restoration of pre-HIV intellectual~     and neurological function. This study also showed an increase in the IQ scores of children~     receiving continuous infusion of AZT who did not have overt clinical evidence of~     encephalopathy (disease of the brain). Thus changes in cognitive function may be among the~     earliest signs of AIDS encephalopathy and underscores the need to start therapies that will~     treat the central nervous system in patients who appear to be clinically intact. A study~     comparing continuous infusion to intermittent dosing of AZT showed a significant increase in~     IQ scores for those children receiving the continuous dose compared to those treated with the~     intermittent schedule. Although a portable infusion pump allows patients to receive~     continuous infusion of AZT, a sustained release oral formulation that could provide a~     continuous release of AZT into the bloodstream would be highly desirable.~   "
272510|NCT00000981|"~     To find oral doses of FIAC (a pyrimidine nucleoside analog) that are effective in treating~     cytomegalovirus (CMV) viremia in HIV-infected immunocompromised patients; to determine~     tolerance and safety of FIAC in this patient population; and to determine pharmacokinetics~     following multiple doses of FIAC. (An example of another nucleoside analog effective against~     retroviruses such as HIV is zidovudine (AZT).) CMV infection is a medically significant~     opportunistic disease in patients with HIV-related infection. The purine nucleoside~     ganciclovir has been used to treat AIDS patients with CMV disease. Although ganciclovir is~     useful in treating CMV disease, such treatment is frequently complicated by hematologic~     (blood) toxicity. Also, treatment is difficult because it requires daily intravenous dosing.~     Test tube studies show that FIAC and its primary breakdown product FIAU are highly and~     specifically active against several viruses including CMV. A single-dose, pharmacokinetic~     (blood level) study showed that FIAC, when taken orally, is readily absorbed into the~     bloodstream, and most of it is converted to FIAU.~   "
272511|NCT00000980|"~     To determine the safety and effectiveness of intravenous spiramycin in patients with~     AIDS-related cryptosporidial diarrhea.~      Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment~     of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the~     symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed~     no significant difference between spiramycin and placebo (inactive medication). A later study~     indicated that the absorption of spiramycin is significantly decreased when food is present.~     Thus, the results of the trial may have been due to poor absorption of spiramycin.~   "
272512|NCT00000979|"~     To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in~     patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4~     counts < 200 cells/mm3.~      AZT is effective in reducing mortality in patients with AIDS who receive the drug after the~     first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.~     However, AZT therapy has been associated with significant toxicities. In addition, the~     effectiveness of AZT appears to decrease during the second and third years of therapy. For~     these reasons, the development of alternative therapy that would be at least as effective but~     less toxic is of great importance. The drug ddI is an antiviral agent that inhibits~     replication (reproduction) of HIV with less apparent toxicity than AZT.~   "
272519|NCT00000972|"~     To evaluate the safety of a fixed antigen dose with an increasing dose of adjuvant~     (MTP-PE/MF59, a substance to enhance the immune response to vaccine) in volunteers. To~     evaluate local and systemic reactions (Part A). To determine the safety and immunogenicity of~     Env 2-3 in combination with MTP-PE/MF59 in volunteers (Part B). The vaccine Env 2-3 is~     created from one of the viral proteins that make up HIV called envelope glycoprotein gp120. A~     problem with many immunogens, including candidate HIV vaccines, is that they may evoke~     relatively weak immune responses, particularly in humans and in nonhuman primates. Thus,~     there is considerable interest in the development of adjuvants (substances that augment~     immune responses to vaccines). MTP-PE/MF59 is an adjuvant that appears to be particularly~     promising, and is selected for the studies with this HIV vaccine candidate.~   "
272513|NCT00000978|"~     To determine the safety, tolerability, and activity of zidovudine (AZT) and zalcitabine~     (dideoxycytidine; ddC) and the bloodstream levels of these drugs in patients with AIDS or~     advanced AIDS-related complex (ARC).~      Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal~     of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and~     ddC may work together in a way that both drugs can be taken at lower doses or less frequent~     intervals when given together. If the doses can be reduced, then toxicity associated with~     long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the~     likelihood of the emergence of resistant mutants. Recent studies indicate a reduced~     sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical~     significance of this finding is not clear, it would indicate that these combination studies~     are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive~     to ddC.~   "
272514|NCT00000977|"~     To determine the minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1~     seropositive individuals with > 400 cells/mm3 (CD4). To determine the dose-response to a 4~     fold escalation of the immunizing dose. To describe both cellular and humoral immune~     responses to HIV-1 in the immunized individuals. To describe the effects of this immunization~     on general immunological, virological and clinical parameters. To evaluate the safety of~     injecting recombinant gp160 in this population. To evaluate the extent of variability between~     different lots of gp160 (arms C1 and C2). It might be possible to increase immune responses~     or to induce new types of immune responses to HIV in some infected individuals by means of a~     vaccine, which could result in an immunological, virological or clinical benefit.~   "
272515|NCT00000976|"~     To determine the safety profile of recombinant human CD4-immunoglobulin G (CD4-IgG) and~     zidovudine (AZT) combination therapy in patients with AIDS or AIDS-related complex (ARC); to~     assess pharmacokinetic (blood level) properties of CD4-IgG in combination with AZT; and to~     obtain preliminary indication of the antiviral and immunologic effects of CD4-IgG in~     combination with AZT in patients with AIDS and ARC.~      Treatment of AIDS has been directed toward the underlying retroviral infection as well as~     toward specific opportunistic infections and malignancies that are associated with the~     syndrome. The most extensively studied drugs are reverse transcriptase inhibitors such as AZT~     and other nucleoside analogs, including didanosine (ddI) and dideoxycytidine (ddC). The most~     extensive clinical experience has been achieved with AZT. These clinical trials indicated a~     decreased incidence of opportunistic infection and increased survival in patients with AIDS.~     However, AZT treatment is associated with dose-limiting toxicities. Additionally,~     identification of resistance to AZT has increased the need to test the effectiveness of AZT~     in combination with other drugs. CD4-IgG is capable of binding to HIV envelope protein~     (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in~     patients with HIV infection may be derived from CD4-IgG.~   "
272516|NCT00000975|"~     To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2)~     maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of~     CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy.~      Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the~     clinical response to amphotericin B treatment in the AIDS patients is generally good,~     administration difficulties and toxicity detract from its usefulness. Oral treatment with~     ketoconazole overcomes these limitations of amphotericin B, but does not appear to be~     effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in~     which preclinical studies have demonstrated activity against Histoplasmosis capsulatum.~     Preclinical studies have also shown that itraconazole appears effective in the treatment of~     histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several~     studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with~     histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole~     has been used successfully in a small number of patients with cryptococcal meningitis,~     supporting a study of its use in CNS histoplasmosis.~   "
272517|NCT00000974|"~     To evaluate the delivery of a single dose of aerosolized pentamidine to children; to evaluate~     the tolerance of pentamidine administration by mask; to compare intravenous pentamidine first~     dose pharmacokinetics (blood levels) in children with information previously collected on~     adults; and to compare plasma pentamidine levels in children after an aerosolized treatment~     with levels previously collected on adults.~      Pneumocystis carinii pneumonia (PCP) is the most common serious infection in children with~     AIDS and is associated with a high death rate. Current approved treatment includes~     intravenous trimethoprim - sulfamethoxazole (TMP / SMX) and intravenous pentamidine, which~     are both effective in treatment of the first episode of PCP pneumonia. However, both~     therapies have a 50 percent or greater incidence of adverse reactions. Because of serious~     toxicities, drug treatment has had to be discontinued. Animal studies show that aerosolized~     pentamidine (pentamidine given through inhalation) is as effective as intravenous~     pentamidine. It is hoped that the aerosolized route will be less toxic than intravenous~     pentamidine. The study is the first step in evaluating the delivery of aerosolized~     pentamidine to children.~   "
272518|NCT00000973|"~     To determine the manner in which pyrimethamine is metabolized and excreted in patients~     currently receiving zidovudine (AZT). An important goal of this measurement is to establish~     the optimal dose of pyrimethamine necessary to prevent the development of toxoplasmosis in~     AIDS patients or delay the subsequent return of toxoplasmic encephalitis.~      Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal~     central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal.~     The best treatment for this disease has not been determined. Presently it is standard~     practice to administer a combination of pyrimethamine and sulfadiazine. Little is known about~     the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT. Furthermore, there~     are reports that patients already exposed to toxoplasmosis may not have uniform absorption of~     pyrimethamine.~   "
272520|NCT00000971|"~     To evaluate three doses of clarithromycin in children with AIDS and Mycobacterium avium~     complex (MAC) infection who are receiving concurrent antiretroviral therapy.~      Before more extensive evaluation of this promising drug for treatment of MAC infection in~     children can be done, it is important to study the pharmacokinetics of this drug in this~     population, to get information regarding its use in pediatric patients receiving currently~     available antiretroviral drugs, and to get information on the antimycobacterial activity of~     this drug.~   "
272521|NCT00000970|"~     To examine the safety and tolerance of the administration of ganciclovir and foscarnet given~     together or alternately; to determine the interactive pharmacokinetics (blood level) profile~     of long-term combined and alternating therapy with these two drugs. Additional objectives are~     to examine the effect of these treatments in controlling time to cytomegalovirus (CMV)~     retinitis progression and to examine the antiviral activity of combined and alternating~     ganciclovir/foscarnet treatment and development of antiviral resistance. Sight-threatening~     CMV retinitis occurs in at least 6 percent of AIDS patients. By 1991 (US), there may be 6000~     to 10000 patients with CMV retinitis. Many clinical reports suggest that both ganciclovir~     (DHPG) and foscarnet have an antiviral effect against CMV that is often associated with~     clinical stabilization. Effectiveness of ganciclovir and foscarnet is correlated with weekly~     maintenance and since toxicity is dose-limiting in up to 20 percent of patients receiving~     either drug for long periods, it may be beneficial in long-term maintenance treatment to~     combine or alternate these two drugs at a lower total weekly dose of each drug.~      This strategy may result in a greater net antiviral effect with less toxicity than is seen~     with either drug alone, because the toxicities of each drug are quite different.~   "
272522|NCT00000969|"~     To evaluate and compare the effectiveness and toxicity associated with didanosine ( ddI ) and~     zalcitabine ( dideoxycytidine; ddC ) in patients with HIV infection who are intolerant of or~     have failed zidovudine ( AZT ) therapy.~      Alternative and less toxic treatments need to be investigated for the treatment of HIV~     infection. Studies have shown that the dideoxynucleosides ddI and ddC may be effective~     antiretroviral agents in the treatment of HIV-infected individuals. However, ddI and ddC have~     yet to be compared on the basis of patient survival, drug tolerance, immunologic and~     virologic effectiveness, and the incidence of opportunistic infection or opportunistic~     malignancy. Results of this study will yield information regarding the relative therapeutic~     benefits and toxicities of each drug while providing alternative treatment to patients who~     are unable to tolerate or have had progression of disease while on AZT.~   "
272523|NCT00000968|"~     To determine the safety of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160)~     in human volunteers; to evaluate the immunogenicity of this preparation in human volunteers.~     Although recent advances have been made in antiviral therapy against AIDS, there is currently~     no cure for AIDS. It is likely that ultimate control of the disease depends on the~     development of safe and effective vaccines against HIV.~   "
272524|NCT00000967|"~     PRIMARY: To determine the maximum tolerated dose of interferon-alfa (IFN-A) alone and in~     combination with zidovudine (AZT); to assess the safety and tolerance of IFN-A alone and in~     combination with AZT.~      SECONDARY: To evaluate the effect of combination IFN-A and AZT on immunologic and virologic~     parameters; to determine whether the pharmacokinetic parameters of AZT are modified by the~     subcutaneous administration of IFN-A.~      AZT is effective in suppressing the progression of HIV infection in patients without symptoms~     or with AIDS or AIDS-related complex (ARC). However, use of AZT is limited by its frequent~     toxicity, which sometimes relates to the amount of drug given. Thus, a combination treatment~     of two drugs that work together may provide more effective and safer treatment. IFN-A is a~     drug that has antiviral effects and may work well with AZT.~   "
272525|NCT00000966|"~     To evaluate the effectiveness and toxicity of oral azithromycin and pyrimethamine as acute~     therapy for toxoplasmic encephalitis in AIDS patients. To assess the toxicity and~     effectiveness of azithromycin alone as maintenance therapy.~      Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous~     system infection in patients with AIDS. Untreated, the encephalitis is fatal. Standard~     treatment for toxoplasmic encephalitis is associated with serious adverse effects. Thus,~     alternative treatments are needed.~   "
272526|NCT00000965|"~     To define the pharmacokinetic parameters (blood levels) of total phosphorylated zidovudine~     (AZT) in peripheral blood mononuclear cells (PBMC) from HIV-infected patients.~      Despite an understanding of the serum (or plasma) pharmacokinetics (blood levels) of AZT, a~     therapeutic concentration range and optimal dosing interval have not yet been determined.~   "
272527|NCT00000964|"~     To see if ranitidine, by reducing stomach acidity, can enhance the effectiveness of~     foscarnet, by making foscarnet more available to the body.~      Foscarnet is an antiviral compound. Laboratory studies have shown it to be active against~     HIV. However, only 12 - 22 percent of an oral foscarnet dose is absorbed by the body.~     Ranitidine suppresses gastric acid output, increasing gastric pH. Thus by increasing gastric~     pH (decreasing stomach acidity), less foscarnet is expected to be decomposed or broken down~     in the stomach. Thus, more foscarnet should be absorbed into the body.~   "
272528|NCT00000963|"~     To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the~     treatment of children with symptomatic HIV disease who have had to discontinue zidovudine~     (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.~      The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The~     benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for~     approximately 12 to 18 months, at which time most patients have progressive deterioration.~     Recently published literature has described a reduced sensitivity of HIV isolated from~     patients after prolonged AZT treatment. Although the clinical significance of this is~     unclear, it makes the development of new antiretroviral drugs important.~   "
272529|NCT00000962|"~     To assess the safety and tolerance of multiple oral doses of Nevirapine (BI-RG-587). To~     generate data on the pharmacokinetics and dose proportionality of Nevirapine with multiple~     dosing. To characterize the pattern of virological activity in vivo. Improvement in~     virological end points will be examined for association with dose and absorption. To~     determine whether development of resistance is reflected in return of virological activity~     and, if so, when markers reflect this resistance. To determine if improvements of~     immunological endpoints are detectable in the number of patients studied. A compound free of~     the toxic effects of nucleoside chain terminators such as zidovudine (AZT) may have an~     advantage over currently available treatments for HIV infection. Such a compound has further~     advantages if it is active against AZT-resistant isolates. Nevirapine (BI-RG-587) has shown~     in vitro inhibitory activity against HIV-1 reverse transcriptase (RT). The molecular~     mechanism of the RT inhibitory effect is hypothesized to be non-competitive inhibition due to~     its binding to an RT site distinct from those for the RNA template primer, the~     deoxynucleotide triphosphate or the RNase H catalytic site.~   "
272531|NCT00000960|"~     To determine whether the rate of HIV transmission from mother to infant can be reduced by~     continuous oral zidovudine (AZT) treatment to HIV infected pregnant women, intravenous AZT~     during childbirth, and oral AZT treatment of the newborn infant from birth to six weeks of~     age. The study is also designed to evaluate the safety of AZT for both the pregnant woman and~     the newborn infant.~      No method exists to prevent transmission of HIV from an infected mother to her newborn~     infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in~     theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to~     maternal virus, or by preventive treatment of the fetus before exposure.~   "
272532|NCT00000959|"~     To evaluate the safety and effectiveness of a 6-month course of isoniazid ( INH ) in the~     prevention of clinical tuberculosis in anergic (having diminished or absent reactions to~     specific antigens) HIV-infected persons who are at high risk for tuberculous infection.~      A substantial number of HIV-infected persons are anergic, and thus do not respond to the only~     currently available diagnostic tool for tuberculosis infection (that is, the PPD (purified~     protein derivative) skin test). Many of these anergic persons are, however, infected with~     Mycobacterium tuberculosis and eventually develop reactivation tuberculosis, causing both~     individual illness and spread of infection to others in the community. This study examines~     the possibility of using INH prophylaxis (that is, for prevention) in anergic HIV-infected~     patients at high risk for tuberculosis as a means of decreasing the sharp rise in the~     incidence of tuberculosis due to HIV infection. INH is inexpensive and relatively safe, and~     thus may demonstrate an acceptable risk/benefit ratio as a medication that can be given over~     a limited period of time to a population suspected of having, but not proved to have, M.~     tuberculosis infection. If this study shows INH to be safe and effective in this setting, it~     could have a major effect on public health in this country.~   "
272533|NCT00000958|"~     To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59~     adjuvant in adult volunteers with HIV infection.~      By vaccinating those who have HIV infection, perhaps the replication (reproduction) of~     existing viral strains can be suppressed and the asymptomatic period early in the infectious~     process can be prolonged. One potential way to do this is to boost HIV antigen-specific CD4~     responses, which may in turn increase the effectiveness of CD8 killing of HIV infected cells.~   "
272534|NCT00000957|"~     To evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope~     glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody~     response and its relationship to the dose and frequency of inoculation.~      Although recent advances have been made in antiviral therapy against AIDS, there is currently~     no cure for AIDS. It is likely that ultimate control of the disease depends on the~     development of safe and effective vaccines against HIV.~   "
272535|NCT00000956|"~     To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope~     glycoprotein gp160. To evaluate the duration of antibody response and its relationship to~     dose and frequency of inoculation.~      Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates~     that, although serum anti-gp160 antibody responses were detected, the level and duration of~     those responses were limited. A preliminary observation suggests that weak functional~     antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a~     dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.~   "
272536|NCT00000955|"~     To quantitate in an HIV-infected population the percentage of patients demonstrating the~     booster phenomenon (attainment of a positive response to a second tuberculin purified~     protein derivative skin test when the first skin test was negative); to determine the~     relationship between the booster phenomenon and CD4-positive lymphocyte cell counts; to~     detect any relationship between the booster phenomenon and HIV exposure category.~      The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is~     dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction;~     however, the DTH response may be impaired or absent in patients with impaired cell-mediated~     immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished,~     but not absent, may test negative the first time a purified protein derivative skin test for~     MTb is administered, but if the same skin test is repeated, a positive DTH response may then~     be elicited. This occurrence is known as the booster phenomenon.~   "
272537|NCT00000954|"~     To determine the toxicity and response to treatment with cytotoxic chemotherapy using~     doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's~     sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC).~      AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic~     agents to reduce the tumor burden, and they also require treatment with other possibly~     effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of~     opportunistic infections.~   "
272538|NCT00000953|"~     To compare the efficacy of oral sorivudine (brovavir) and oral acyclovir for the treatment of~     localized herpes zoster in HIV-infected patients.~      HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster~     virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used~     to treat VZV infections in the HIV population. Since no data from controlled studies are~     available to define the role of antiviral therapy for VZV infections in HIV-infected~     patients, a study is needed to test the relative efficacy of brovavir, an experimental~     antiviral drug, versus that of acyclovir.~   "
272539|NCT00000952|"~     The study examines the safety and effectiveness of ritonavir (an anti-HIV drug), alone and in~     combination with other anti-HIV drugs, in HIV-positive children under 2 years of age. This~     study will also determine the most effective doses of ritonavir for future pediatric HIV~     studies.~      Infants infected with HIV by their mothers experience faster disease progression than adults~     or older children. Treatment with anti-HIV drugs administered at an early age may slow~     disease progression in infant populations.~   "
272540|NCT00000951|"~     The purpose of this study is to determine whether it is better to treat patients with~     fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from~     coming back or to wait and treat each episode of thrush.~      Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast~     infections. However, the number of patients with fluconazole-resistant thrush is increasing,~     and it is not known whether continuous or intermittent use of fluconazole leads to greater~     resistance. Therefore, it is important to determine the most effective treatment strategy.~   "
272542|NCT00000949|"~     The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4~     counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to~     increase CD4 cell counts, which help the body fight off HIV.~      There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system~     that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4~     cell count and the amount of HIV in the blood (viral burden).~   "
272543|NCT00000948|"~     The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus~     anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the~     immune system that fight infection) of at least 350 cells/mm3. This study will also examine~     the ability of antiretroviral therapy combined with IL-2 to boost the immune system.~      IL-2, given through injection under the skin, in combination with anti-HIV therapy can~     increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the~     safest and most effective dose to use.~   "
272544|NCT00000947|"~     This study is designed to find out whether HIV-positive patients whose immune systems have~     improved after receiving anti-HIV treatment should take azithromycin to prevent Mycobacterium~     avium complex (MAC) disease. This study also examines the possibility of putting off MAC~     prevention treatment in patients who respond well to anti-HIV drug therapy.~      Azithromycin is approved for the prevention of MAC disease in people with HIV and low CD4~     cell counts. However, some people who have taken azithromycin have been found to carry~     antibiotic-resistant bacteria (germs that can grow despite the presence of drugs used to kill~     them). It is not known whether the risks associated with taking azithromycin outweigh the~     risk of getting MAC disease.~   "
272545|NCT00000946|"~     The purpose of this study is to test three experimental HIV vaccines. This study will look at~     whether it is safe to give these vaccines together and how the immune system responds to the~     vaccines.~      There are a number of studies being performed to test HIV vaccines. The vaccines that seem to~     be the most promising are canarypox vaccines, known as ALVAC vaccines. The three experimental~     HIV vaccines used in this study are called ALVAC-HIV vCP205, HIV-1 SF-2 p24, and HIV-1 SF-2~     rgp120. The HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120 vaccines are mixed with an adjuvant, which~     is a substance that increases immune response.~   "
272546|NCT00000945|"~     The purpose of this study is to evaluate the safety, tolerance, and overall effectiveness of~     cidovir to treat PML in AIDS patients.~      PML is an opportunistic infection (HIV-associated, due to weak immune system) caused by a~     virus that attacks the brain. Cidovir has been used effectively to treat cytomegalovirus~     (CMV) of the eye. Cidovir could be an effective treatment for PML as well.~   "
272547|NCT00000944|"~     The purpose of this study is to determine if a combination anti-HIV drug treatment regimen of~     indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in~     reducing the chances of passing HIV from mother to child. This study will also examine if~     this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC~     plus ZDV is safe for newborns.~      Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can~     reduce the amount of HIV in the blood. Most HIV-positive pregnant women usually take ZDV to~     treat HIV and to reduce the chances of giving HIV to their babies. The combination of drugs~     in this study may be more effective than ZDV alone.~   "
272548|NCT00000943|"~     The purpose of this study is to determine the effects of an HIV vaccine (Remune) on the~     immune system. This study involves patients who have received at least 60 weeks of anti-HIV~     therapy, either alone or in combination with IL-2, while enrolled in ACTG 328.~      Remune is an experimental HIV vaccine. To see how the body's immune system reacts, this~     vaccine will be given with 1 to 3 other vaccines, and skin tests will monitor the body's~     reaction.~   "
272549|NCT00000942|"~     The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to~     HIV-positive pregnant women and their babies can help reduce the chance that a mother will~     give HIV to her baby during delivery.~      Previous studies suggest that NVP is a promising medication for blocking HIV transmission~     from HIV-positive mothers to their babies.~   "
272550|NCT00000941|"~     The purpose of this study is to find out whether taking protease inhibitors (anti-HIV drugs)~     together with lipid-lowering drugs (drugs which lower the amount of fat in the blood) has an~     effect on the level of drugs found in the blood compared to when these drugs are taken~     separately. The three protease inhibitors given in this study are ritonavir, saquinavir, and~     nelfinavir. The lipid-lowering drugs given are pravastatin, simvastatin, and atorvastatin.~      Anti-HIV drug therapy using protease inhibitors has become very common treatment for~     HIV-positive patients. Recently, however, serious side effects involving how the body uses~     fat have been reported in people taking protease inhibitors. Examples of these side effects~     are redistribution of body fat and development of diabetes. People taking protease inhibitors~     have been found to have higher levels of fat in their blood than is normal, which can cause~     heart problems. It is hoped that giving lipid-lowering drugs can help prevent serious heart~     problems. First, however, it is important to see what happens when protease inhibitors and~     lipid-lowering drugs are given together.~   "
272551|NCT00000940|"~     This study will determine what effect taking a combination of five anti-HIV drugs during the~     early stage of HIV infection, then temporarily stopping them once or twice, may have on the~     amount of HIV virus in the blood (viral load). The study will also evaluate the safety and~     effectiveness of this anti-HIV drug combination.~   "
272552|NCT00000939|"~     This study will look at different anti-HIV drug regimens to see which works best to keep the~     level of HIV (viral load) in the blood as low as possible during maintenance therapy. You~     will be assigned randomly (like tossing a coin) to 1 of 3 groups:~      Group 1: Didanosine plus stavudine plus hydroxyurea (ddI/d4T/HU). Group 2: Didanosine plus~     stavudine plus efavirenz (ddI/d4T/EFV). Group 3: This group of patients will remain on their~     current drug regimens. This study will last approximately 3 years; you will receive study~     medications for the duration of the study.~      Anti-HIV drug regimens that include protease inhibitors (PIs) are very good at lowering viral~     load. However, some patients have a rise in HIV levels while on PI maintenance. It may be~     possible to keep HIV levels low using another class of drugs for maintenance that are easier~     to take and less expensive than PIs. If viral load increases while a patient is taking this~     second group of drugs, it may be possible to restart the PI drug regimen and again decrease~     HIV levels.~   "
272553|NCT00000938|"~     Lyme disease is the most common tick-borne disease in the United States. It is caused by the~     spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1)~     persistent infection by B. burgdorferi; 2) damage caused by the original infectious process;~     or 3) the presence of coinfection with another organism transmitted by Ixodes ticks. The~     purpose of this study is to determine the safety and effectiveness, in seronegative patients,~     of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).~   "
272554|NCT00000937|"~     The purpose of this study is to see how well antibiotics work in reducing chronic fatigue~     symptoms, such as tiredness, in patients that were treated for Lyme Disease. Fatigue is a~     common symptom of Lyme Disease. When fatigue does not improve after treatment, patients are~     considered to have Post Lyme Syndrome (PLS). The chronic fatigue seen in these patients~     appears to be related to the initial infection which causes Lyme Disease. It is believed, but~     not proven, that treatment with antibiotics may be effective in relieving chronic fatigue in~     PLS patients.~   "
272555|NCT00000936|"~     Kidney transplantation is often successful. However, despite aggressive anti-rejection drug~     therapy, some patients will reject their new kidney. This study is designed to test two~     anti-rejection approaches. Two medications in this study are currently used in children, but~     there is no information regarding which drug is safer or more effective.~      Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for~     an improved post-transplant treatment, such as the induction therapy used in this study.~   "
272556|NCT00000935|"~     This study is designed to test the clinical and laboratory observations that suggest IVIG~     given before and after kidney transplant to patients who are sensitized (highly sensitive) to~     certain transplant antigens could result in reduced sensitization and reduced rates of kidney~     rejection.~      Some ESRD patients are highly sensitive to certain transplant antigens (foreign substances~     that activate the immune system) and must wait for a long time before a well-matched kidney~     becomes available. Transplant rejection is more likely among highly sensitized patients than~     in patients who are not highly sensitized. There is no proven method to improve a~     highly-sensitized patient's chances of receiving and keeping a transplanted kidney.~   "
272557|NCT00000933|"~     Some people who have taken azithromycin to prevent MAC (Mycobacterium avium Complex, a~     bacterial infection common in HIV-infected persons) have been found to carry~     antibiotic-resistant bacteria (germs that grow despite the presence of drugs used to kill~     them). The purpose of this study is to see if people who take azithromycin carry more~     antibiotic-resistant bacteria than people who have chosen to delay MAC preventive therapy.~      When bacteria like Streptococcus (a type of bacteria that causes pneumonia and meningitis)~     are frequently exposed to antibiotics, the bacteria can become resistant to the drugs. MAC~     preventive therapy uses antibiotics, but this can make it difficult to treat other infections~     caused by bacteria that have become resistant in HIV-infected persons. If MAC preventive~     therapy is delayed, Streptococcus in the body may be less likely to develop resistance.~     Therefore, if the patient does get a Streptococcus infection, it will be easier to treat~     because it is not resistant to the antibiotics.~   "
272558|NCT00000932|"~     The purpose of this study is to collect information about life spans and HIV-related~     illnesses in multiple groups of HIV-positive patients with varying anti-HIV treatment~     experience, including no treatment at all.~      Anti-HIV treatment has been successful in slowing disease progression in many patients.~     However, there are still questions regarding the best way to use anti-HIV drugs. This study~     is designed to provide long-term monitoring of patients who have already received anti-HIV~     treatment as well as patients who are just beginning treatment or have decided not to receive~     treatment.~   "
272559|NCT00000931|"~     The purpose of this study is to see if a behavioral intervention, a special kind of~     counseling, can reduce the risk of HIV infection in men who have sex with men. The behavioral~     intervention will be compared to the standard risk reduction counseling that is given before~     and after getting an HIV test.~      In standard pre- and post-test counseling, everyone is told the same things about how to~     prevent HIV. The behavioral intervention used in this study is designed to help each~     individual prevent HIV according to his specific problems and needs.~   "
272560|NCT00000930|"~     The purpose of this study is to see how HIV reacts in the immune systems of patients who have~     recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs~     in newly infected patients.~      Certain populations are good candidates for participation in HIV vaccine trials. These groups~     include men who have sex with men, IV drug users, and women at risk of getting HIV through~     heterosexual contact. Learning how HIV behaves in these populations once they become infected~     can help with the planning of future HIV vaccine studies.~   "
272561|NCT00000929|"~     The purpose of this study is to see if it is safe and acceptable for homosexual male couples,~     where both partners have the same HIV status, to use Advantage 24 during anal intercourse.~     Advantage 24 is a spermicide (a chemical that kills sperm).~      Much research and development is being done with chemicals that can be controlled by the~     receptive partner to prevent the spread of HIV and other sexually transmitted diseases~     (STDs). Advantage 24 currently is used in the vagina as a form of birth control. The safety~     of Advantage 24 is particularly important for HIV-positive men because they have a greater~     chance of serious reaction to Advantage 24 due to other HIV-related conditions.~   "
272562|NCT00000928|"~     To assess the acceptability of and participation in a group counseling intervention,~     including an assessment of willingness to disclose serostatus to a regular sexual partner and~     the willingness of that partner to participate. To evaluate the profile of adverse~     experiences (social, psychological, and physical harms) of individuals resulting from~     participation in counseling and testing and attempts to initiate condom use within a stable~     HIV serodiscordant partnership. To assess the potential for the intervention to result in~     increased condom use among stable sexual partners.~      There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant~     couples. While condom use has been a major component of most AIDS prevention programs since~     the mid-1980s, there has been little emphasis on promoting condom use within stable~     partnerships. The most effective way to promote condom use among discordant couples remains~     largely unknown.~   "
272906|NCT00021866|"~     The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their~     neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ~     in their behavioral and cognitive development depending on which AED their mother takes~     during pregnancy?~   "
272563|NCT00000927|"~     The purpose of this study is to see if it is safe to use BufferGel in the vaginas of women~     who do not have HIV and who have a low risk of getting HIV.~      Many new cases of HIV are the result of heterosexual activity. Condom use is currently the~     only effective way of preventing the spread of HIV and other sexually transmitted diseases~     (STDs). However, women, who have a greater risk of getting HIV, are often unable to convince~     their partner to use a condom. Therefore, it is important to develop methods that prevent the~     spread of HIV and that are controlled by the woman, such as medicines used in the vagina.~     BufferGel is known to kill the organisms that cause STDs, including HIV. BufferGel may do~     this without causing genital irritation and sores as other medicines do. More studies are~     needed to see if this is true.~   "
272564|NCT00000926|"~     The purpose of this study is to see if nonoxynol-9 (N-9) gel used in the vagina can prevent~     the spread of HIV.~      Most of the people with HIV in the world today live in southern Africa. Because this~     population is not likely to use condoms, an HIV-prevention method that women can control is~     needed. N-9 used in the vagina may help prevent the spread of HIV and other sexually~     transmitted diseases.~   "
272565|NCT00000925|"~     The purpose of this study is to determine whether a high-quality protein food supplement will~     help HIV-positive patients maintain, and possibly gain, muscle mass.~      Many HIV-positive patients lose weight that they are then unable to regain. This may be~     because patients are not eating enough protein or are not eating the right kinds of protein.~     The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the~     amount of protein lost due to HIV infection. This study gives patients high-quality protein~     food supplements to help them maintain and/or gain weight.~   "
272566|NCT00000924|"~     This study compares 2 different anti-HIV drug regimens to determine which is the most~     effective in lowering the amount of HIV in the blood. The anti-HIV drugs used in this study~     are 2 protease inhibitors (nelfinavir and ritonavir), 2 nucleoside reverse transcriptase~     inhibitors (stavudine and didanosine), and 1 nonnucleoside reverse transcriptase inhibitor~     (nevirapine).~      These drug combinations have been previously studied in adults, but there is limited~     information on how well they work in HIV-infected children. It is important to develop drug~     combinations which are effective at suppressing the HIV virus in children.~   "
272567|NCT00000923|"~     This study examines the long-term effects of interleukin-2 (IL-2) in combination with~     anti-HIV drugs, or highly active antiretroviral therapy (HAART). The purpose of this study is~     to see if IL-2 can increase the number of CD4 cells (cells of the immune system which fight~     infection) in HIV-infected patients who have completed ACTG 328.~      HAART is often successful in decreasing viral load (level of HIV in the blood), but these~     drugs have not been able to restore the immune systems of HIV-infected patients. IL-2 is a~     substance naturally produced by the body's immune cells. In ACTG 328, IL-2 is tested to see~     if it can increase the number of CD4 cells and boost a patient's immune system. This study~     is a follow-up to ACTG 328 so that patients who are benefiting from IL-2 can continue to take~     it and patients in the control group who do not receive IL-2 can start taking it.~   "
272568|NCT00000922|"~     The purpose of this study is to determine whether it is better to start an anti-HIV regimen~     containing a protease inhibitor (PI), a non-nucleoside reverse transcriptase inhibitor~     (NNRTI), or a PI in combination with an NNRTI. This study will also examine which treatment~     regimen is best as a first treatment for HIV infection.~   "
272569|NCT00000921|"~     The purpose of this study is to see if it is safe and effective to give prednisone to~     HIV-infected patients.~      Prednisone is a corticosteroid, a hormone produced by the body that inhibits immune cell~     responses. Prednisone may be able to lower the level of HIV in the body (viral load) by~     reducing the number of cells that HIV can infect. At the same time, prednisone may be able to~     increase CD4 cell counts (cells of the immune system that fight infection).~   "
272570|NCT00000920|"~     The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with~     low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant~     women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to~     see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of~     ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes~     from mother to newborn and if it passes at a level that is safe for the newborn.~      Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it~     may be possible to reduce it further by using a combination of anti-HIV drugs. This study~     adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase~     inhibitor) to the mother's ZDV regimen.~   "
272571|NCT00000919|"~     The purpose of this study is to compare the effectiveness of various combinations of anti-HIV~     drugs in HIV-positive men and women. Patients receive specific combinations of 3 or 4 of the~     following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV),~     lamivudine (3TC), or zidovudine (ZDV).~      Anti-HIV therapy is effective in preventing the spread of HIV in the body. However, patients~     often experience unpleasant side effects and have difficulties following the dosing schedule.~     This study looks for combinations of anti-HIV drugs (cocktails) which will be the most~     effective with the fewest problems.~   "
272572|NCT00000918|"~     The purpose of this study is to determine the safety and effectiveness of combining several~     anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in~     HIV-positive patients who have failed nelfinavir (NFV) treatment.~      In order to determine the ability of a drug regimen to decrease viral load after drug~     treatment has failed, it is best to test a variety different of drug cocktails (drug~     regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase~     inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and~     either 1 or 2 protease inhibitors. It is important to include multiple drugs from different~     groups in a drug cocktail since combinations containing fewer drugs are likely to fail.~   "
272573|NCT00000917|"~     The purpose of this study is to set up a blood bank for infants who have HIV-positive~     mothers. This blood may be used in the future to treat the child if he/she turns out to be~     HIV-positive.~      Blood from the umbilical cord contains a certain kind of cell called a stem cell. Stem cells~     eventually turn into one of the many types of blood cells. If HIV infection can be prevented~     in these stem cells, then, when these stem cells are injected back into the infant, the new~     cells that develop will also be protected from HIV. This study will provide the blood needed~     to test whether this type of gene therapy is safe and effective.~   "
272574|NCT00000916|"~     This study compares the safety and effectiveness of continuing your current anti-HIV~     medications to that of adding or switching some of your anti-HIV medications. It will follow~     the effect of these medication changes, including the addition of hydroxyurea (HU), on~     long-term viral suppression. Other medications which may be added include didanosine (ddI)~     and/or stavudine (d4T).~      Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine~     (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more.~     Discontinuation of one or two of these drugs results in prompt loss of the viral suppression.~     Other studies show that addition of HU to some reverse transcriptase inhibitor treatments~     results in increased antiviral effects. This study will provide further information on the~     effect of adding HU to a treatment regimen with respect to long-term viral suppression.~   "
272575|NCT00000915|"~     The purpose of this study is to estimate the rate at which a certain population becomes~     infected with HIV. The individuals examined in this study are people who are expected to take~     part in future studies of HIV vaccines and nonvaccine HIV prevention studies. This study also~     examines the chances of becoming HIV-positive based on certain risk factors under conditions~     that are similar to the conditions that would exist in HIV vaccine and non-HIV prevention~     studies.~      Before studying the effectiveness of a potential HIV vaccine, it is important to learn about~     the range of HIV risk behaviors in the potential participants of these studies. The~     probability of HIV infection associated with these risk behaviors should also be examined.~     This study is designed to increase the ability of HIVNET to put into place HIV prevention~     trials, to increase the diversity of trial participants, and to target populations at highest~     risk for HIV infection.~   "
272576|NCT00000914|"~     The purpose of this study is to compare different treatments for HIV infection to see which~     works best to lower HIV levels and to raise the number of CD4 cells (cells of the immune~     system that fight infection), in HIV-positive individuals who have been on a protease~     inhibitor-containing drug regimen for at least 16 weeks.~      Researchers have found that combination anti-HIV therapy (multiple drugs given together) can~     help prevent AIDS-related illnesses and help people with AIDS live longer. In this study, the~     anti-HIV drug efavirenz (EFV) will be tested with 1 or 2 other protease inhibitors (PIs) to~     see which combination works best to treat HIV infection. EFV has been shown to limit the~     amount of HIV virus produced by infected cells.~   "
272577|NCT00000913|"~     The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule~     formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with~     other anti-HIV drugs.~      SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is~     still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule~     form may be safer and more effective than other protease inhibitors.~   "
272578|NCT00000912|"~     The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to~     determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while~     on the treatment. This study evaluates the safety of these drug combinations, which include~     an experimental protease inhibitor (PI), amprenavir.~      Despite the success that many patients have had with PI treatment regimens, there is still a~     possibility that patients receiving PIs may continue to have high HIV blood levels. Because~     of this possibility, alternative drug combinations containing PIs are being studied. It~     appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in~     patients with prior PI treatment experience.~   "
272579|NCT00000911|"~     The purpose of this study is to monitor patients who recently have been infected with HIV in~     order to learn how their immune systems respond to HIV infection and to study how the virus~     acts in their bodies.~      Primary HIV infection occurs within 20 days to 8 weeks following exposure to HIV. The~     symptoms of primary HIV infection are usually fever, tiredness, headache, or muscle aches.~     However, symptoms vary greatly from person to person, and some people might not experience~     any symptoms at all. Because these symptoms also resemble the cold or the flu, it is~     difficult to identify patients with primary HIV infection. Information gathered from this~     study will help doctors decide what kind of treatment is best to give patients who recently~     have been infected.~   "
272580|NCT00000910|"~     The purpose of this study is to collect medical information about HIV-positive pregnant women~     and their babies who have been (or are being) seen at study sites. This information will be~     used to help design future research studies for these patients.~      The population of HIV-positive pregnant women and their babies who are seen at study sites~     has not been officially examined. In order to design future studies to research the best care~     for these patients, this study will examine important characteristics and the general number~     of women in these trials.~   "
272581|NCT00000909|"~     The purpose of this study is to evaluate the safety and tolerability of giving interleukin-2~     (IL-2) alone to HIV-positive patients with CD4 cell counts greater than 350 cells/mm3 who do~     not wish to receive anti-HIV (antiretroviral) therapy. This study will also determine if IL-2~     given alone can increase CD4 cell counts or decrease the level of HIV in the blood.~      IL-2 (a protein found in the blood that helps boost the immune system) can result in~     increases in CD4 cell count (immune system cells that fight infection). IL-2 is normally~     given in combination with antiretroviral therapy to treat HIV infection; however, some HIV~     patients do not wish to take antiretrovirals. This study asks if it is safe and effective to~     take IL-2 alone to treat HIV infection.~   "
272582|NCT00000908|"~     The purpose of this study is to see how often Pneumocystis carinii pneumonia (PCP) occurs in~     HIV-positive patients who have stopped taking medications that help prevent PCP.~      The risk of developing PCP may be decreased when an HIV-positive patient's CD4 cell counts~     (cells of the immune system which fight infection) are more than 200 cells/mm3. This study~     looks at whether it is acceptable to stop PCP prevention treatment in these patients.~   "
272591|NCT00000899|"~     The purpose of this study is to determine the safety of anti-HIV drugs combined with low-dose~     chemotherapy (consisting of cyclophosphamide [CTX]) in HIV-positive patients. This study~     examines whether this combination therapy can reduce the number of HIV-infected cells hidden~     in the lymph nodes and blood.~      Current anti-HIV drug treatments can greatly reduce the levels of HIV in the human body.~     However, HIV can hide in certain immune cells and escape the drugs' effects. Chemotherapy~     using CTX destroys these immune cells. When used with standard anti-HIV drug treatments, CTX~     may be able to speed up the elimination of HIV-infected cells.~   "
272583|NCT00000907|"~     The purpose of this study is to evaluate the effects of stopping preventive therapy for DMAC~     in HIV-positive patients who (1) have been treated for DMAC for at least 12 months and are~     now free of any signs of DMAC for at least 16 weeks, and (2) have improved immune systems~     (CD4 cell counts greater than or equal to 100 cells/mm3) due to anti-HIV drug therapy.~      DMAC is a serious and sometimes life-threatening infection that usually affects only~     HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection)~     less than 50 cells/mm3. It is recommended that people who are likely to get DMAC be placed on~     preventive medications which help reduce the risk of infection. New anti-HIV combination drug~     therapies can increase CD4 cell counts and can reduce the level of HIV in the blood. When CD4~     counts are increased, risk of DMAC infection is less. This study examines whether it is~     possible to stop preventive therapy for DMAC when CD4 counts are high without placing~     individuals at risk for getting DMAC again.~   "
272584|NCT00000906|"~     The purpose of this study is to see if it is safe to combine methadone with two HIV protease~     inhibitors (PIs), ritonavir (RTV) and saquinavir (SQV), in HIV-infected patients not~     currently taking PIs. This study will measure the interactions between methadone and the PIs.~      Methadone is used treat addicts and to treat severe pain. In order to find the safest way to~     use methadone with PIs, it is important to evaluate how they interact.~   "
272585|NCT00000905|"~     The purpose of this study is to see if it is safe to stop maintenance therapy in HIV-positive~     patients with treated and healed CMV retinitis (eye disease) who have responded well to~     anti-HIV (antiretroviral) therapy.~      The current therapies available to treat CMV retinitis are long-term therapies. However, it~     may be safe to stop long-term anti-CMV therapy in patients with healed CMV retinitis and~     stable CD4 counts resulting from taking a combination of at least 2 antiretroviral drugs.~   "
272586|NCT00000904|"~     The purpose of this study is to find out whether three different anti-HIV vaccines are safe~     and whether they help prevent HIV infection. These vaccines are called vCP205, vCP1433, and~     vCP1452. Some patients also receive another anti-HIV vaccine, gp160. The vaccines are made up~     of small pieces of HIV, which help the body learn to recognize and destroy HIV. You cannot~     get HIV from these vaccines.~      There are two different ways a vaccine can protect the body from infection. First, a vaccine~     may help the immune system make antibodies, which are proteins that recognize invading~     viruses or bacteria. Second, a vaccine may help the body make immune cells that destroy~     infected cells. The second type of vaccine is more powerful against HIV. In this study,~     doctors will see whether vCP205, vCP1433, vCP1452, and gp160 are good vaccines by seeing~     whether they help the body make immune cells.~   "
272587|NCT00000903|"~     To compare time to a virologic failure (first of 2 consecutive plasma HIV RNA levels greater~     than or equal to 200 copies/ml at or after Week 24) of each 4-drug regimen vs the 3-drug~     regimen. To determine the safety, tolerance, and virologic benefits of either nelfinavir~     (NFV) or efavirenz (EFV) with indinavir/lamivudine/zidovudine (IDV/3TC/ZDV) vs IDV/3TC/ZDV~     alone, in the treatment of patients with advanced HIV disease who have received limited or no~     prior antiretroviral therapy.~      Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in~     improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced~     effects seen with combination therapies are likely related to a greater suppression of RNA~     replication and alterations in resistance patterns. Due to the progressive success of~     combination regimens, it is possible that more potent regimens will further enhance viral~     suppression and provide more durable treatment responses. In light of the additive~     suppression of HIV replication determined by pharmacological, immunological, and virological~     results, nelfinavir (NFV) as an addition to IDV/ZDV/3TC will be evaluated. Based on the~     potency of nonnucleoside reverse transcriptase inhibitors (NNRTIs) to suppress viral~     replication and the effectiveness of 3-drug regimens containing NNRTIs, efavirenz (EFV) will~     also be evaluated as an addition to IDV/ZDV/3TC.~   "
272588|NCT00000902|"~     The purpose of this study is to determine the value of changing anti-HIV medications in~     children with progressive HIV disease who have received previous treatment.~      Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by~     giving patients anti-HIV drugs which affect the virus at various stages of development.~     Changing the medications may enhance the results of treatment.~   "
272589|NCT00000901|"~     The purpose of this study is to see if it is safe and effective to give an anti-HIV drug~     combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected~     children. IDV will be given either as a powder mixed into applesauce or as capsules given on~     an empty stomach.~   "
272590|NCT00000900|"~     To describe the magnitude and duration of changes in HIV-1 RNA levels during and after an~     acute febrile illness. To identify factors associated with increases, i.e., type of illness~     ultimately diagnosed (bacterial, viral, fungal), CD4 cell count, and antiretroviral treatment~     regimen. To describe changes in phenotypic markers of immune activation/dysregulation of CD4~     and CD8 lymphocyte subsets and their relationship to intercurrent illness. To describe~     changes in plasma cytokines and soluble activation markers and their relationship to plasma~     HIV-1 viremia during and after the onset of intercurrent illness. To characterize the viral~     biologic phenotype and the viral drug susceptibility genotype before, during, and after the~     onset of an acute febrile illness. To characterize the expression of HIV-1 co-receptors~     before, during, and after the onset of an acute febrile illness Repeated episodes of~     intercurrent infections have been postulated to be an important stimulus for progression of~     HIV infection. The study of intercurrent illness in patients with initially undetectable~     viral load removes viral load as a possible cause for virologic and immunologic changes and~     allows for a more direct association of the intercurrent illness with changes in viral load,~     viral HIV-1 phenotypes, viral HIV-1 genotypes, and T cell phenotypes. Studying intercurrent~     illness and viral load provides an opportunity to characterize the potentially dynamic~     changes not only in viral load but also in phenotypic markers of T cell activation, plasma~     cytokine levels, phenotypic and genotypic changes in circulating virus, and HIV-1 tropisms.~   "
272592|NCT00000898|"~     The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and~     saquinavir has any effect on the interactions between these drugs.~   "
273064|NCT00015080|"~     The purpose of this study is to determine the efficacy of naltrexone in the treatment of~     cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2)~     decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in~     treatment.~   "
272593|NCT00000897|"~     The purpose of this study is to look at the effects of different methods of birth control~     (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV).~     This study will also evaluate the differences in men and women in how the body absorbs, makes~     available, and removes ZDV.~      Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased~     in individuals who use certain methods of birth control. ZDV may also have different effects~     in men compared to women.~   "
272594|NCT00000896|"~     The purpose of this study is to examine how the level of HIV is reduced in the blood when~     anti-HIV therapy is initiated. This study will also evaluate whether adding GM-CSF or IL-12~     to the anti-HIV drug regimen will increase the rate that HIV is reduced.~      The anti-HIV drugs used in this study will include lamivudine (3TC), zidovudine (ZDV),~     indinavir (IDV), nevirapine (NVP), and stavudine (d4T). All have been used successfully to~     treat HIV. GM-CSF has been used to treat certain blood disorders; it will be used as an~     experimental drug in this study. IL-12 (interleukin-12) is a protein found naturally in the~     body that is thought to boost the immune system. Although GM-CSF and IL-12 have no direct~     effect against HIV, these drugs may improve the ability of the immune system to fight the~     virus.~   "
272595|NCT00000895|"~     The purpose of this study is to determine if infection with Mycobacterium avium complex (MAC)~     occurs in other parts of the body before it is found in the blood. This study also evaluates~     the relationships between the amount of HIV in the blood, immune system functions, and the~     presence of MAC infection.~      HIV-positive patients are at risk for MAC infection because their immune systems have been~     weakened by HIV. It is hoped that aggressive treatment with anti-HIV drugs may improve their~     immune systems enough to prevent against MAC.~   "
272596|NCT00000894|"~     To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth~     (oral) and through an eye device (intraocular) , in order to determine the safety and~     effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by~     CMV (cytomegalovirus) retinitis.~      Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV~     retinitis.~   "
272597|NCT00000893|"~     Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV~     medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find~     an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this~     study is to see how safe it is to give EFZ syrup combined with NFV and to measure the levels~     of EFZ and NFV in the blood. (This purpose reflects a change from the original since there~     are now 2 different cohorts of patients.) EFZ is an effective anti-HIV medication that easily~     can be combined with other drugs to treat HIV. This is an early study to determine a safe and~     effective dose for HIV-positive children. This study also will examine the correct dose of~     NFV to use in combination with EFZ.~   "
272598|NCT00000892|"~     To compare the proportion of patients whose plasma HIV-1 RNA is below 500 copies/ml after 16~     weeks of treatment. To assess the safety, toxicity, and tolerance of each treatment arm.~      While indinavir is currently the most commonly prescribed protease inhibitor, the optimal~     therapy for a person on an indinavir-containing regimen who experiences a rebound in viral~     load or never experiences a decrease in viral load below 500 copies per milliliter is~     unknown. Current clinical practice for such patients typically involves empiric use of a~     combination of other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir) and~     at least 1 other antiretroviral agent to which the patient has had little or no prior~     exposure. This may involve the use of 1 or more reverse transcriptase inhibitors (RTIs) or~     nonnucleoside reverse transcriptase inhibitors (NNRTIs). This study attempts to formally~     evaluate some of these options in indinavir-experienced patients.~   "
272599|NCT00000891|"~     To evaluate the relationship between viral suppression and changes in immune function, as~     measured by the restoration of delayed-type hypersensitivity (DTH) and lymphoproliferative~     (LP) responses, observed after 48 weeks of treatment with highly active antiretroviral~     therapy (HAART) in ACTG 315. To evaluate the durability of the antiviral and immunologic~     effects of long-term treatment with HAART.~      Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies~     of this advanced-disease population are indicated to primarily ascertain the impact of~     long-term suppression of viral replication on immunologic reconstitution or re-education and~     the durability of the antiviral effects of HAART.~   "
272600|NCT00000890|"~     The purpose of this study is to determine whether HIV-positive patients with extremely low~     viral loads (level of HIV in the blood) have a greater gain in lean tissue during anti-HIV~     (antiretroviral) therapy than patients with higher viral loads.~      Many HIV-positive patients experience changes in body composition (muscle, fat, etc.) while~     on antiretroviral therapy. However, any weight gained while taking antiretrovirals is mostly~     fat. A patient's viral load may affect whether weight gained is a result of increased fat or~     increased muscle. A large-scale study is needed to closely evaluate the effects of~     antiretroviral therapy on body composition.~   "
272601|NCT00000889|"~     To demonstrate the safety and tolerability of subcutaneously administered interleukin-2~     (IL-2) plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cells/mm3 or~     more. To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus~     antiretroviral therapy relative to antiretroviral therapy alone.~      IL-2, given through injection under the skin, in combination with anti-HIV therapy can~     increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the~     safest and most effective dose to use.~   "
272602|NCT00000888|"~     The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus~     lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to~     their babies after birth.~      Pregnant women who are HIV-positive are at risk of giving HIV to their babies during~     pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women~     from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against~     HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV~     infection from mother to infant but studies are needed to determine whether they are safe and~     effective during pregnancy.~   "
272943|NCT00018694|"~     The treatment of cerebrotendinous xanthomatosis an in born error of bile acid synthesis with~     chenodeoxycholic acid. Patients with this disease over produce cholestanol and bile acid~     precursors because of the block in synthesis. Replacement with chenodeoxycholic acid shut~     down abnormal pathway and reduces elevated level of cholestanol and improves the clinical~     syndrome.~   "
272603|NCT00000887|"~     The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus~     lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will~     also look at how long these drugs stay in the blood.~      ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their~     babies. However, better treatments are needed to further reduce these chances and to better~     suit the treatment needs of mothers and their children. Taking a combination of anti-HIV~     drugs during pregnancy may be an answer.~   "
272604|NCT00000886|"~     To evaluate the safety of HIV-1 gp120 C4-V3 hybrid polyvalent peptide immunogen (C4-V3~     peptides) formulated in mineral oil containing mannose mono-oleate (IFA) in HIV-1 uninfected~     volunteers. To evaluate the humoral and cellular immune responses to the C4-V3 peptides as~     measured by the induction of 1 or more of the following: neutralizing antibodies to HIV-1 MN~     and RF, cross-neutralizing antibodies to primary isolates of HIV-1, HIV-1 antigen-specific~     lymphoproliferation, CD8+ and CD4+ cytotoxic T lymphocyte (CTL) activity specific for HIV-1~     gp120 or V3 peptides corresponding to the vaccine strains of HIV-1, induction of HLA-B7 and~     HLA-A2 restricted CD8+CTLs, and induction of HIV-specific DTH responses.~      The test immunogen (C4-V3 peptides) is constructed from 4 sequences of the HIV-1 V3 gp120~     loop shared by approximately 80% of North American HIV-1 strains. Because of the critical~     role that this region plays in generating anti-HIV sequences, it is hypothesized that the~     test immunogen (C4-V3 peptides) will be capable of inducing a broad range of cross-reactive~     neutralizing antibodies in the majority of recipients.~   "
272605|NCT00000885|"~     Group A:~      To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA~     concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or~     placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To~     evaluate the safety and tolerability of these treatment arms. [AS PER AMENDMENT 06/16/99: To~     compare the time to confirmed treatment failure, permanent discontinuation of treatment, or~     death between the treatment arms.] [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed~     follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.]~      Group B:~      To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500~     copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the~     absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC~     or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz~     (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms.~      Group C:~      To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma~     HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients~     treated with ZDV or stavudine (d4T) plus 3TC and IDV.~      Group D:~      To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and~     tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV.~      This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited~     number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and~     are currently exhibiting a range of virologic responses. By dividing the study into the~     corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating~     virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e.,~     plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or~     more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER~     AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only~     information pertinent to Group A is applicable. This study will examine the question of~     whether intensification of therapy can prolong the virologic benefit in individuals whose~     plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T)~     plus 3TC plus IDV.]~   "
272606|NCT00000884|"~     To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein,~     delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular~     immune responses resulting from ALVAC-HIV vCP205. [AS PER AMENDMENT 8/3/98: To obtain safety~     data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the~     context of previous immunization via alternate mucosal routes or intramuscularly with a~     canarypox vector expressing HIV-1 antigens (vCP205). To obtain immunogenicity data on AIDSVAX~     B/B boosting.] One of the earliest observations in the HIV epidemic was the demonstration of~     HIV infection at mucosal surfaces of cells in the genital tract. These data suggest that~     priming of immune defenses of viral infected cells may be an important component in the~     strategy of developing an effective HIV vaccine. Direct immunization of relevant mucosal~     surfaces with a vectored vaccine may stimulate mucosal immunity. The ALVAC-HIV vCP205~     immunogen is constructed from a live recombinant canarypox vector that has a good safety~     profile in volunteers and should allow mucosal induction of immunity.~   "
272607|NCT00000883|"~     The purpose of this study is to see if there are any changes in sugar and fat levels in the~     blood when patients take anti-HIV therapy for many years. Another goal is to test memory and~     mental concentrations to determine if anti-HIV drugs protect the brain from damage caused by~     HIV.~      (The purpose of this study has been changed from the original version.) HIV-infected patients~     with low CD4 cell counts are at risk for getting opportunistic (AIDS-related) infections. CD4~     cells are cells of the immune system that help fight infection. Anti-HIV therapy may increase~     CD4 counts, which may lead to a decrease in AIDS-related infections. Problems that anti-HIV~     therapy is associated with include metabolic problems, neurologic problems, abnormal~     opportunistic infections, and cancer. Patients in ACTG 362 have been exposed to anti-HIV~     therapy longer than any other large group in the ACTG. These patients appear to benefit from~     their therapy, but also suffer problems from it. Observation of these patients should provide~     more information about long-term anti-HIV treatment and may detect unexpected problems.~      (This study as been changed. More information about the reasons for conducting this study has~     been added.)~   "
272608|NCT00000882|"~     To compare the proportion of patients in the 2 zidovudine (ZDV)-containing arms who have a~     plasma HIV RNA concentration below the limit of detection (defined as 500 copies/ml or less)~     at Weeks 20 and 24 [AS PER AMENDMENT 8/24/98: HIV RNA concentration below the limit of~     detection is now defined as 200 copies/ml or less]. To compare the safety and tolerability of~     the different treatment regimens. To compare the decrease in plasma HIV-1 RNA and the change~     in CD4 count from baseline to the average of Weeks 20 and 24 [AS PER AMENDMENT 12/19/97: and~     to the average of Weeks 44 and 48; AS PER AMENDMENT 8/24/98: and the average of Weeks 88 and~     96] in the 2 ZDV-containing arms. To study the emergence of resistance to ZDV, lamivudine~     (3TC), stavudine (d4T), delavirdine (DLV), and indinavir (IDV) in treated patients. To~     correlate the antiviral and immunologic activity and emergence of drug resistance with~     pharmacologic parameters of study drugs. To delineate the pharmacokinetic interactions of IDV~     and DLV. [AS PER AMENDMENT 12/19/97: To delineate the possible development of cellular~     resistance to nucleoside analogs and the consequences of switching nucleoside study drugs on~     intracellular phosphorylation.] To document rates and patterns of adherence over the course~     of the study, from day of randomization through 48 weeks. [AS PER AMENDMENT 8/24/98: To~     define long-term durability of the virologic activity of the different treatment regimens, as~     defined by the proportion of patients with plasma HIV-1 RNA levels that remains below the~     limit of detection. To define long-term tolerability of the different treatment regimens.]~     Although a change in reverse transcriptase (RT) inhibitors is recommended when adding or~     changing protease inhibitors in a treatment regimen, the choice of available RT inhibitors is~     often limited by prior exposure, toxicity, or pharmacologic interaction with the protease~     inhibitors. This study addresses the question of whether to continue 3TC or substitute the~     nonnucleoside reverse transcriptase inhibitor (NNRTI) DLV when adding IDV to therapy for~     patients previously treated with ddI or d4T plus 3TC who have greater than 500 copies/ml of~     plasma HIV-1 RNA. Although the activity of DLV as monotherapy or in combination with~     nucleoside reverse transcriptase inhibitors is of limited duration due to rapid emergence of~     resistance, it is possible that DLV will contribute significantly to the activity of 3-drug~     regimens that include a new RT inhibitor plus a protease inhibitor.~   "
272718|NCT00000771|"~     To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in~     the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of~     oral paromomycin at two different doses. To explore whether paromomycin administered over a~     longer period provides additional benefit.~      In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with~     paromomycin therapy.~   "
272609|NCT00000881|"~     Part A: To determine the safety and pharmacokinetics of sequential single doses of cidofovir~     in HIV-infected children with end-organ cytomegalovirus (CMV) disease. Part B: To determine~     the safety (including time to progression of CMV retinitis by retinal exam),~     pharmacokinetics, and long-term (6 months) tolerance of multiple-dose cidofovir in~     HIV-infected children with CMV retinitis. Part B: To determine the effect of multiple-dose~     cidofovir on the virologic parameters of CMV retinitis (viral load, shedding, and resistance~     to antiviral agents).~      [AS PER AMENDMENT 1/7/98: To determine the safety, tolerance and pharmacokinetics of~     sequential single doses of cidofovir in HIV-infected children with CMV retinitis. To~     determine the safety (including time to progression of CMV retinitis by retinal exam),~     pharmacokinetics, and long-term (6-month) tolerance of multiple doses of cidofovir in~     HIV-infected children with CMV retinitis.] While the intravenous formulation of cidofovir has~     been approved for the treatment of CMV retinitis in HIV-infected individuals, information is~     limited regarding its safety and tolerance in HIV-infected children. Intravenous cidofovir~     requires less frequent administration for both induction and maintenance therapy of CMV~     retinitis than other currently available therapies. If found to be safe and well tolerated in~     HIV-infected children with CMV retinitis, intravenous cidofovir would add significantly to~     agents available to treat this debilitating opportunistic infection.~   "
272610|NCT00000880|"~     The purpose of this study is to determine the safety and effectiveness of low doses of~     cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the~     immune system.~      Activation of T cells (cells of the immune system) leads to HIV replication. Inhibition of~     immune activation is therefore a potentially important area of therapy for patients with~     early HIV infection. CsA is capable of decreasing T cell activation, which in turn may~     decrease HIV replication.~   "
272611|NCT00000879|"~     The purpose of this study is to see if giving the ALVAC vCP1452 anti-HIV vaccine alone or~     with another vaccine called AIDSVAX B/B to babies of HIV-positive mothers is safe. The study~     will also look at how these vaccines affect a baby's immune system. Most HIV-positive~     children get HIV from their mothers during pregnancy or birth. Treatment with anti-HIV drugs~     can reduce the baby's risk of getting HIV. Vaccines also may help prevent HIV infection. This~     study will look at whether the ALVAC vCP1452 vaccine and the AIDSVAX B/B vaccine can help the~     body fight off HIV infection. There is no chance of getting HIV infection from the vaccines.~     (This study has been changed. In earlier versions, ALVAC vCP205 and AIDSVAX B/E were going to~     be used.)~   "
272612|NCT00000878|"~     The purpose of this study is to evaluate the safety and tolerance of 2 anti-HIV drugs, d4T~     and 3TC, given in combination to HIV-positive pregnant women and their infants.~      Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV~     and reduce the chances of giving HIV to their babies. It recently has been shown that a~     combination of drugs may be more effective than ZDV alone. This study tests the effectiveness~     of combinations of ZDV, d4T, and 3TC.~   "
272613|NCT00000877|"~     The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the~     same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative~     adults.~      It is important to determine which medications for HIV-associated diseases, such as~     Mycobacterium avium complex (MAC) disease, can be given safely and effectively with anti-HIV~     drugs. Indinavir and rifabutin have been given simultaneously in the past with good results.~     This study seeks to examine if staggering the doses will make the 2 drugs more effective.~     HIV-negative volunteers are used in this study to examine the effect of rifabutin on~     indinavir and the effect of staggered rifabutin doses. The effect of rifabutin on the drug~     activity of indinavir is evaluated in HIV-positive patients.~   "
272614|NCT00000876|"~     CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4~     cells (cells of the immune system that fight infection). The purpose of this study is to see~     if giving CD4-IgG2 to HIV-infected children is safe and effective.~      HIV attaches to CD4 cells and enters them. Inside, HIV makes copies of itself that will help~     the virus invade the body. CD4 cells are killed or disabled during this process of HIV~     replication. Decreases in CD4 cells lead to a weakened immune system. When CD4 cell counts~     become very low, the body is unable to defend itself, and HIV infection develops into AIDS.~     The protein used in this study, CD4-IgG2, may be able to attach to HIV and inactivate it so~     that it cannot enter CD4 cells. This is an early study to examine CD4-IgG2 as a possible~     treatment for HIV in children.~   "
272615|NCT00000875|"~     To evaluate the safety of anti-HIV CTL therapy in early stage patients and to verify the~     safety when combined with antiviral therapy with zidovudine/lamivudine/indinavir and low-dose~     interleukin-2 (IL-2). To compare the effects on plasma and cell-associated viral load~     following combination drug therapy with and without antiviral CTL in early-stage patients. To~     study in detail the immune effects of lowering viral burden with antiviral combination drugs~     with and without T cell infusion on antiviral CTL activity, viral suppression and~     proliferation, circulating T cell phenotype, T cell apoptosis, CD4 cell numbers, DTH~     reaction, and inflammatory cytokine levels.~      In an HIV-infected person, there is an ongoing struggle between HIV replication and host~     immune control. In the past decade most therapeutic strategies have targeted the virus. This~     approach has been frustrated by viral mutation to evade drug sensitivity. Promising drugs~     have recently been approved and there are encouraging sustained results from combination~     antiviral chemotherapy. However, even the most potent drug regimens do not seem to be~     curative, may eventually lead to drug resistance and may not completely restore lost immune~     function. The addition of immune-based therapy to antiviral drugs may lead to better viral~     control.~   "
272639|NCT00000851|"~     To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone~     and in combination with didanosine (ddI), and whether concurrent administration alters the~     disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long~     term changes from baseline in plasma HIV RNA concentrations. To determine the relationship,~     if any, between drug exposure and viral burden.~      In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the~     three children with baseline counts greater than 50 cells/micro liter experienced a 20%~     increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the~     same regimen for children with less advanced HIV disease should be undertaken.~   "
272944|NCT00018681|"~     This study investigates distribution and regulation of bile acid transport in the human~     intestine.~   "
272616|NCT00000874|"~     To determine the short-term virologic and immunologic effects of using plasma genotypic~     antiretroviral resistance testing (GART) results (interpreted by study virologists AS PER~     AMENDMENT 9/17/97) in the management of therapy for antiretroviral-experienced patients~     failing on one of the following regimens:~        1. zidovudine (ZDV) + (lamivudine) 3TC + (indinavir) IDV~        2. ZDV + 3TC + saquinavir (SQV)~        3. ZDV + 3TC + ritonavir (RTV)~        4. stavudine (d4T) + 3TC + IDV. [AS PER AMENDMENT 11/26/97: To determine the short-term~          effects of using plasma GART in the management of antiretroviral-experienced patients~          failing on a triple drug regimen that includes a single protease inhibitor (indinavir~          [IDV], saquinavir [SQV], ritonavir [RTV], or nelfinavir [NFV]) and two licensed~          nucleoside reverse transcriptase inhibitors (NRTIs).] A growing body of evidence~          suggests that antiretroviral resistance is associated with an increased risk of disease~          progression and death. All commercially available antiretrovirals and many of those in~          development have been associated with resistance. Fortunately, techniques are available~          to define HIV genotypic resistance in real time as compared to techniques that measure~          phenotypic resistance that is not practical in a clinical setting. Using genotypic~          antiretroviral resistance testing (GART) results, along with other currently available~          markers, may lead to improved treatment decisions compared with using currently~          available markers alone.~   "
272617|NCT00000873|"~     This study examines the effects of an infant formula containing increased calories, as~     compared to commercial formulas, when given during the first 6 months of life. It will~     examine effects on growth, disease progress, immune system, and quality of life of infected~     infants.~      HIV disease in infants often leads to nutritional deficiencies. Providing increased nutrition~     early in their lives may help the quality of life of children who contract HIV from their~     mothers.~   "
272618|NCT00000872|"~     This trial tests the safety and effectiveness of the early use of combinations of anti-HIV~     drugs in HIV-infected infants and young children in an effort to block virus growth and~     preserve normal immune functions.~      Various anti-HIV drug combinations need to be tested in order to find the best way to treat~     infants and children who have been infected with HIV during birth.~   "
272619|NCT00000871|"~     To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine~     strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. [AS PER AMENDMENT 7/2/98: To~     obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing~     antibody response to primary isolates of HIV-1 in the context of previous immunization with a~     canarypox vector expressing HIV antigens (vCP205). To evaluate cytotoxic T lymphocyte~     responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205~     alone.] In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies~     that neutralize homologous laboratory strains; over 50% of patients have developed CD8+~     cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This~     Phase II study seeks to confirm these results among persons at lower or higher risk for HIV~     infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential~     large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts~     starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced~     neutralizing antibody response as deemed from prior studies and thus is planned as~     follow-up therapy.]~   "
272620|NCT00000870|"~     To compare two different routes of intermittently administered rhIL-2 with a highly active~     antiretroviral regimen (HAART) to HAART alone. The comparison is based on the following:~     proportion of patients achieving at least 50-percent increase in CD4 counts above~     prerandomization baseline values after 1 year of rhIL-2 and the rate of change in CD4 counts.~     To compare the safety and tolerance of these regimens and their effect on quality of life. To~     assess the effects of rhIL-2 when combined with HAART on changes in immune cell phenotypes~     and function and on HIV viral load and the rate of antiviral drug resistance development.~      The poor responsiveness of late stage HIV-infected patients to rhIL-2 is thought to occur~     because of low T cell regenerative capacity and high viral burden. If means were available to~     effectively suppress virus replication, the indigenous immune restorative responses of the~     host may be further stimulated and enhanced by rhIL-2. The use of protease inhibitors with~     nucleoside-analogue combination regimens appears to be most effective in controlling virus~     replication. High-dose intermittent rhIL-2 administered either intravenously or~     subcutaneously has been shown to be effective in inducing CD4 responses in a number of~     studies.~   "
272621|NCT00000869|"~     The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to~     HIV-positive pregnant women and their babies can help reduce the chance that a mother will~     give HIV to her baby during delivery. This study will also test the safety of the drug and~     see how well it is tolerated by the mother and her baby.~      Previous studies suggest that NVP is a promising medication for blocking HIV transmission~     from HIV-positive mothers to their babies.~   "
272622|NCT00000868|"~     The purpose of this study is to evaluate the safety and effectiveness of giving healthy~     volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This~     oral vaccine (HIV-1 LAI gp120) will be given with or without a different injected HIV vaccine~     (HIV-1 MN rgp120).~      Vaccines are preparations that are introduced into the body to try to prevent infection or~     create resistance to infection. This study examines a new oral vaccine to see if it can~     improve the immune system's ability to fight the HIV virus when given alone or with another~     injected vaccine.~   "
272623|NCT00000867|"~     The purpose of this study is to determine the safety and effectiveness of memantine, an~     experimental drug, in improving AIDS dementia complex (ADC).~      The symptoms of ADC can be improved with zidovudine (ZDV). However, ZDV therapy has been~     associated with significant toxicities, and the effectiveness of ZDV seems to decrease during~     the second and third years of therapy. The effectiveness of other antiretroviral drugs as~     treatment for ADC is not known, so it is important to explore alternative therapies.~   "
272653|NCT00000837|"~     The purpose of this study is to see if it is safe to give Varivax to HIV-positive children~     and whether it protects children from infection. Varivax is a vaccine against varicella~     zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).~      VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine~     that has been approved for use in healthy children. More research is needed to find out how~     this vaccine will affect HIV-infected children.~   "
272624|NCT00000866|"~     To evaluate the safety of administering Therion Recombinant Vaccinia-HIV-1 IIIB env/gag/pol~     Vaccine (TBC-3B) vaccinations to vaccinia-naive individuals. To evaluate the immunogenicity~     of priming with TBC-3B by the scarification, intradermal, and subcutaneous routes, followed~     by booster immunization of MN rgp120 HIV-1. To compare the immunogenicity of priming with~     TBC-3B in vaccinia-naive individuals to vaccinia-immune individuals.~      In prior trials evaluating alternative methods of vaccine administration, scarification has~     been found to be an imprecise method of administration and allows only 1.0 - 2.5 microliters~     of immunogen to be given. Since it is not feasible to produce vaccine at concentrations~     higher than 10 to the 10th pfu/ml, this method limits the maximum deliverable dose.~     Intradermal and subcutaneous injection routes allow larger volumes of vaccinia to be given,~     i.e.: up to 200 microliters intradermally and up to 100 ml subcutaneously. In the present~     study, the initial priming dose will be the same administered by all 3 methods; however, the~     second priming dose administered at 2 months intradermally and subcutaneously will be 2 logs~     higher in order to achieve boosting of immune responses, particularly to gag and pol~     components of TBC-3B.~   "
272625|NCT00000865|"~     To assess the steady state pharmacokinetic features, tolerance, and safety of orally~     administered 1592U89, given alone or in combination with other antiretroviral medications, in~     HIV infected infants and children. To establish doses of 1592U89 appropriate for future~     pediatric Phase II/III clinical trials.~      On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent~     for treatment of HIV infection in children, either as an alternative to currently employed~     agents, or in combination therapy regimens. A liquid formulation of the drug is available;~     thus concurrent development of 1592U89 for children and adults is possible.~   "
272626|NCT00000864|"~     The purpose of this study is to determine the safety, tolerance, and metabolism of~     single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard~     postnatal treatment with zidovudine (ZDV). This study also evaluates the correct dosages of~     ABC to be used in future studies.~      Early aggressive therapy may be the best chance to slow disease progression in infants who~     may have been infected with HIV by their mothers. Early HIV suppression may significantly~     reduce viral levels and allow for restoration of the immune system, providing improved~     control over HIV infection. Therefore, it is important that the safety and tolerance of ABC~     in combination with ZDV be examined as potential early therapy in newborn and young infants.~   "
272627|NCT00000863|"~     To evaluate the efficacy of WR 6026 once daily in the treatment of mild PCP. To evaluate the~     safety and tolerance of WR 6026. To assess the correlation between plasma WR 6026~     concentrations and outcome/toxicity.~   "
272628|NCT00000862|"~     To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral~     administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile~     to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of oral ZDV in~     this population, defined as the ability to take oral doses and lack of vomiting within 30~     minutes of receiving oral study doses.~      The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not~     practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV~     ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more~     practical method of delivering ZDV during labor and delivery that, at minimum, will~     approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would~     enable women to start an intensive ZDV regimen during early labor, even prior to reaching the~     hospital.~   "
272629|NCT00000861|"~     The purpose of this study is to evaluate the effect of immediate versus deferred indinavir~     (IDV) in addition to background therapy on disease progression or death in patients with CD4+~     cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels >= 10,000 copies/ml.~      This study aims to examine two management strategies, immediate versus deferred IDV therapy,~     for their clinical effects in the context of background antiretroviral (AR) therapy, given~     according to current clinical practice. There is an urgent need to identify the optimal use~     of IDV in patient management, since clinical endpoint studies have not been completed in the~     United States. Since there is little information about the long term durability of clinical~     effects, and even less information about the timing of the initiation of protease inhibitor~     therapy, exploring the disease progression and survival impact of immediate versus delayed~     use of IDV will yield important information to guide clinical decision making for this group~     of patients.~   "
272630|NCT00000860|"~     To determine if treatment of MAC infection in HIV-1 infected persons is associated with the~     decreases in plasma levels of TNF-alpha.~      Infection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests~     that this poor outcome is not simply a reflection of greater immune impairment in AIDS~     patients with MAC infection, but rather may be a direct or indirect consequence of infection~     with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC.~     Studies show that treatment for MAC improves the survival of MAC infected patients to nearly~     the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing~     regimens is associated with decreased symptoms and prolonged survival. There is evidence,~     however, that mycobacterial infection may enhance propagation of the human immunodeficiency~     virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines.~     It is unclear to what extent cytokine abnormalities contribute to this symptom complex and to~     what extent treatment of MAC infection will reverse these cytokine abnormalities.~   "
272640|NCT00000850|"~     The purpose of this study is to see how HIV-positive patients who are taking anti-HIV drugs~     and have a viral load (level of HIV in the blood) of 1,500 copies/ml or more respond to~     GM-CSF (granulocyte-macrophage colony-stimulating factor).~      GM-CSF is a medication that is being tested in HIV-positive patients to see if it can improve~     their immune systems or if it can lower the level of HIV in their blood. GM-CSF is often~     given to patients with leukemia or patients who have received bone marrow transplants to~     increase their white blood cells and to improve their immune systems. Doctors believe that~     GM-CSF can increase CD4 counts in HIV-positive patients, but this study will also look at how~     GM-CSF affects viral load.~   "
272686|NCT00000804|"~     The purpose of this trial is to study L-735,524, which is an inhibitor of the HIV protease~     enzyme. It will be used with interleukin-2 in patients infected with HIV.~   "
272631|NCT00000859|"~     To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in~     HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 [AS PER AMENDMENT~     3/11/98: less than or equal to 200 cells/mm3]. To compare NFV with RTV for the development of~     adverse events and for rates of permanent discontinuation of study medication.~      [AS PER AMENDMENT 10/02/97: To compare by intention-to-treat analysis for disease~     progression, including death, the following two regimens: NFV plus background combination~     antiretroviral (AR) therapy followed by indinavir (IDV) or RTV in the event of significant~     intolerance; and RTV plus AR therapy followed by IDV, then NFV, in the event of significant~     intolerance.] [AS PER AMENDMENT 3/11/98: SUBSTUDY CPCRA 045: To determine the relative rates~     of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+~     cell counts in a sample of patients with CD4+ cell counts <= 200/mm3 who are enrolled in~     protocol CPCRA 042.] AR therapy is rapidly becoming the standard of care for the treatment of~     HIV infection. AR therapy provides the best opportunity for maximizing viral suppression,~     reducing toxicity and delaying the emergence of resistant strains. The newest class of AR~     agents, the HIV protease inhibitors, exhibits the most potent anti-HIV effects described to~     date. This study will compare 2 protease inhibitors, NFV and RTV for efficacy and safety in a~     population with advanced HIV disease, who are taking various background nucleoside therapies.~   "
272632|NCT00000858|"~     To correlate HIV-1 viral load in vaginocervical secretions (VCS), as measured by culture and~     nucleic acid detection, with that found in peripheral blood and HIV clinical status. To~     determine whether systemic and local HIV specific antibody influences the quality and type of~     virus isolated from VCS. To ascertain whether the presence of specific infectious agents~     (e.g., HPV, HSV, CMV, etc.) influences the amount and type of virus isolated from VCS.~      Predictors for the development of the acquired immunodeficiency syndrome (AIDS) in HIV~     infected individuals have been studied primarily among adult males and in selected small~     populations. Although many of these predictors may be relevant to women, HIV infection does~     manifest itself differently between the sexes. Therefore, it is important to study the~     spectrum of HIV disease in women and to identify unique and common markers, cofactors, and~     predictors of disease progression.~   "
272633|NCT00000857|"~     The purpose of this study is to determine the tolerance and effectiveness of rhIL-12 in~     HIV-positive patients with CD4 cell counts less than 50 cells/mm3 versus 300-500 cells/mm3.~     This study will look at the ability of rhIL-12 to boost the immune system against HIV and~     HIV-associated bacterial infections in these patients.~      IL-12 is found naturally in the body and rhIL-12 is the commercially produced version. IL-12~     may enhance anti-HIV immune system activity by increasing the number of cells that fight~     infection. IL-12 may also increase the body's ability to fight bacterial infections such as~     Mycobacterium avium complex (MAC).~   "
272634|NCT00000856|"~     To determine the safety and CSF penetration of combined ganciclovir and foscarnet treatment~     for presumed cytomegalovirus encephalitis or radiculomyelopathy.~      This study proposes to investigate the use of combined ganciclovir and foscarnet to maximize~     the antiviral regimen. Current evidence suggests that a combination of ganciclovir and~     foscarnet may be the most efficacious therapy and appears to be well tolerated. This study~     will provide key information regarding safety and CSF penetration of the drugs available for~     treatment of these lethal diseases. It will also provide preliminary information regarding~     virologic factors relevant to CMV CNS disease. The study will also provide further data about~     the natural history of CMV brain infection detected by a combination of symptom complex and~     PCR identification of CMV in CSF and the potential of semi-quantitative PCR evaluation of the~     CSF for the disease.~   "
272635|NCT00000855|"~     The purpose of this study is to examine the safety and tolerability of ZDV when given to~     premature infants born to HIV-positive women to prevent HIV infection.~      ZDV has been used successfully to prevent the transmission of HIV from mother to child during~     pregnancy and birth. However, ZDV has been given to very few premature babies, and the best~     dose to use has not yet been determined.~   "
272636|NCT00000854|"~     The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will~     cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting).~      Wasting has become an AIDS-defining condition. In the past, most studies that examined~     wasting treatments were limited to men. However, it appears that wasting in HIV-positive men~     is linked to levels of testosterone (a hormone which affects men's bodies more than women's).~     This study has been designed for women only, in order to best treat wasting in HIV-positive~     women.~   "
272637|NCT00000853|"~     To expand the safety information regarding MN rsgp 120/HIV-1 formulated with QS21 or alum. To~     evaluate the immunogenicity of low doses of MN rsgp 120/HIV-1 formulated with QS21 or alum.~      Studies to date indicate that there may be a dose-sparing effect with the use of QS21. In~     animal studies, when QS21 has been employed as an adjuvant, it shifted both the dose response~     curve and allowed less antigen to elicit equivalent binding antibody titers to the rgp120~     protein. There may also be an acceleration in the course of antibody response after both the~     first and the second immunizations. Although the final titers in response to vaccine given in~     both alum and QS21 appear similar after 3 doses in humans, this plateau may be reached more~     readily, and with a lower antigen dose, when using QS21 as an adjuvant. In addition, it has~     been established that using a lower dose of antigen may elicit an immune response which is~     characterized by lymphoproliferation and production of TH1-like cytokines such as INF-gamma,~     interleukin-2, interleukin-4, interleukin-5 and interleukin-10.~   "
272638|NCT00000852|"~     To examine, in HIV-infected patients, the safety of allogeneic lymphocyte transfer (i.e.,~     infusion of white blood cells taken from an HIV-negative parent, sibling, or adult offspring~     who has a compatible blood type). To measure the distribution and survival of allogeneic~     lymphocytes in the circulation of HIV-infected patients, and to determine whether their~     infusion results in enhanced immunity. To determine whether enhanced immunity is passively~     transferred or actively induced.~      There is evidence that periodic infusion of allogeneic lymphocytes obtained from the~     peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in~     some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled~     studies are needed to better quantitate the immunologic reconstitution seen with this type of~     therapy.~   "
273658|NCT00005729|"~     To promote cardiovascular health through nutritional education in a low literacy population~     enrolled in English as a Second Language (ESL) courses in the San Diego Community College~     District.~   "
272641|NCT00000849|"~     The purpose of this study is to determine the safety and maximum tolerated dose (the highest~     dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children.~     This study also evaluates the effect of rIL-2 on the immune system of these patients.~      IL-2 is a substance naturally produced by the body's white blood cells that plays an~     important role in helping the body fight infection. HIV-infected patients do not produce~     enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in~     these patients. First, it is necessary to determine the safety and effectiveness of this drug~     in HIV-infected children.~   "
272642|NCT00000848|"~     To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule~     formulation of saquinavir or to indinavir following prolonged use of the original hard~     capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA.~      Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have~     shown that cross-resistance occurs among protease inhibitors, although no clinical trials~     have been conducted to examine antiretroviral activity with sequential use of protease~     inhibitors or to determine whether saquinavir resistance can be overcome with higher~     concentrations of the drug.~   "
272643|NCT00000847|"~     To evaluate the safety and immunogenicity of high-titered ALVAC-HIV MN120TMG (vCP205) given~     sequentially or simultaneously with rgp120/HIV-1SF2 in MF59 adjuvant emulsion in HIV-negative~     volunteers.~      ALVAC-HIV vCP205 is a second-generation candidate vaccine that can be used to induce a~     humoral and cellular response against several antigens. vCP205 expresses proteins from two~     strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of~     HIV. This study will help to show how the immune system responds to proteins from more than~     one strain of virus.~   "
272644|NCT00000846|"~     To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the~     UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched~     peptide when administered sequentially by 2 different routes of immunization, parental~     priming followed by oral boosting.~   "
272645|NCT00000845|"~     To evaluate an HIV synthetic lipopeptide candidate vaccine component, P3C541b, at two dose~     levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled~     study.~   "
272646|NCT00000844|"~     To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e.,~     Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate~     differences in response to oral interferon alpha according to gender, race/ethnicity, and use~     of antiretrovirals.~      Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha~     have produced different results, and it is not clear whether the differences were due to the~     interferon alpha products used or to problems in the study design. Therefore, three~     preparations will be compared to evaluate their potential efficacies.~   "
272647|NCT00000843|"~     To evaluate the single-dose pharmacokinetic profile and acute toxicity of bis-POM PMEA (~     adefovir dipivoxil ) in HIV-1 infected children, and to determine whether age-related~     differences exist. To ascertain dosages that may be suitable for a multiple-dose evaluation~     in this patient population.~      Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has~     resulted in increased bioavailability in adult patients in clinical trials. However, the~     safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and~     the direction of the variation is not predictable. This study will assess these parameters of~     bis-POM PMEA in children.~   "
272648|NCT00000842|"~     To assess the efficacy, safety, and tolerability of recombinant human nerve growth factor (~     rhNGF ) in the treatment of HIV-associated sensory neuropathy. AS PER AMENDMENT 5/6/97: To~     compare the change in viral load between the double-blind phase baseline and week 4 in~     placebo and active rhNGF recipients. To ensure that rhNGF does not induce an increase in~     viral load compared with viral load changes seen with placebo.~      Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on~     pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important~     in the development and maintenance of sympathetic and sensory neurons and their outgrowths,~     it is proposed that recombinant human nerve growth factor may provide a specific restorative~     treatment for HIV-associated painful sensory neuropathy.~   "
272649|NCT00000841|"~     To determine the clinical efficacy of indinavir sulfate or placebo in combination with~     zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients.~      Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV~     disease who have received prior AZT therapy. Since studies suggest that triple drug therapy~     may have an advantage over both monotherapy and two drug therapy, the combination of~     indinavir sulfate with AZT and 3TC should be evaluated.~   "
272650|NCT00000840|"~     To evaluate viral load in the blood stream of HIV-infected patients during a 28-day washout~     following cessation of long-term zidovudine ( AZT ) therapy.~      Because viral load (amount of HIV RNA in the plasma) is often used as a measure of the~     effectiveness of new antiretroviral drugs in clinical trials, a washout period, or cessation~     of current antiretroviral regimens, is commonly required for study entry to allow for a~     drug-free steady state of viral load prior to initiation of the new drug. However, the~     kinetics of the viral rebound following drug withdrawal has not been sufficiently studied,~     and the proper duration of washout is an estimate.~   "
272651|NCT00000839|"~     To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI)~     administration in third trimester pregnant women who are HIV positive but are either~     intolerant or resistant to zidovudine (AZT). To collect data on infant toxicity following~     maternal treatment with ddI during the third trimester of pregnancy.~      AZT may not be the optimal antiretroviral agent for all pregnant women requiring therapy for~     HIV infection. Although ddI has been approved for use in HIV-infected adults and older~     children, the safety and pharmacokinetics of ddI in pregnant women has not yet been~     determined.~   "
272652|NCT00000838|"~     To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with~     zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI~     monotherapy in HIV-infected patients with no prior nucleoside therapy.~      3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC~     resistance mutations. One explanation is that the M184V mutation, which confers resistance to~     3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy~     with other nucleoside analogs.~   "
272654|NCT00000836|"~     To compare the safety and efficacy of sevirumab (MSL 109; Protovir), human~     anti-cytomegalovirus (CMV) monoclonal antibody, plus active primary treatment versus placebo~     plus active primary treatment in AIDS patients with newly diagnosed and relapsed CMV~     retinitis.~      Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic~     toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these~     drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL~     109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may~     increase initial response and prolong time to progression in patients with CMV retinitis.~   "
272655|NCT00000835|"~     The purpose of this trial is to determine the safety and immunogenicity of an HIV-1~     pseudovirion vaccine given at one antigen dose alone and in combination with each of two~     different adjuvants using two immunization schedules.~      The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral~     proteins which are capable of assembly into particles. The presence of gag gene products in~     addition to envelope glycoprotein should assist in humoral and cellular immunologic responses~     to internal HIV-1 viral proteins. The pseudovirion vaccine has been tested in preclinical~     trials in mice, guinea pigs, rabbits, and nonhuman primates with good safety and~     immunogenicity profile.~   "
272656|NCT00000834|"~     To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine~     the dose effective in modulating key markers of immune activation. To determine a dose~     suitable for Phase II or III evaluation in HIV-infected patients.~      In HIV infection, complete immunological clearance of the foreign antigen does not occur,~     resulting in chronic immune activation. Because chronic immune activation may contribute to~     disease progression in HIV infection, immunomodulators may have therapeutic value in early~     HIV disease prior to development of opportunistic infections. The clinical benefits of~     methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state~     of chronic immune activation.~   "
272657|NCT00000833|"~     To compare the safety, toxicity, and tolerance of two doses of ribavirin in combination with~     didanosine (ddI) to HIV-infected children. To determine the toxicity of ddI/ribavirin and~     compare it to the expected toxicity of ddI monotherapy. To determine the effect of concurrent~     ribavirin on the pharmacokinetics of ddI. To determine a dosage of ribavirin that would be~     suitable for a Phase II/III evaluation of ddI/ribavirin.~      Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of~     didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the~     intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of~     ddI.~   "
272658|NCT00000832|"~     To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant~     emulsion versus MF59 alone in HIV-negative volunteers.~      One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine~     the immunogen with an adjuvant.~   "
272659|NCT00000831|"~     To elucidate the relationship between virologic risk factors and immunologic and clinical~     progression in patients receiving monotherapy in protocol ACTG 175, and to compare new~     treatment regimens with combinations of reverse transcriptase inhibitors in long-term~     recipients of monotherapy. Specifically, to determine, in patients who have been taking~     zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to~     AZT or to switch to d4T alone, and also to determine, in patients who have been taking~     didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to~     ddI.~      Characteristics of virus replication, pathogenicity, and resistance are thought to determine~     the durability of virologic and clinical response to nucleoside reverse transcriptase~     inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of~     ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response~     compared to continuation of AZT alone.~   "
272660|NCT00000830|"~     To determine the levels of zidovudine triphosphate ( AZT-TP ) in maternal and fetal cord~     blood mononuclear cells. To determine the ratio of AZT-TP to endogenous nucleoside~     triphosphate levels in maternal and fetal cells. To determine the extent of drug transfer~     through the feto/placental unit.~   "
272661|NCT00000829|"~     To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate~     vaccine have more local reactions at the site of injection and systemic reactions than~     placebo subjects. To assess whether this vaccine is more immunogenic than placebo following~     the third vaccination.~      Children with HIV infection are at increased risk for invasive pneumococcal infection,~     particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited~     number of serotypes. The maximum number of pneumococcal serotypes that can be included in a~     new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent~     pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular~     saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin~     mutant carrier protein.~   "
272662|NCT00000828|"~     To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with~     perinatal HIV transmission.~      Most HIV-infected infants acquire their disease via perinatal transmission. Since~     transmission of HIV-resistant strains to infants could alter the course of disease and~     response to currently recommended treatment, a study to assess the patterns of AZT~     susceptibility among mother/infant pairs with perinatal transmission is essential to~     delineate future therapeutic strategies.~   "
272663|NCT00000827|"~     To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV~     immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.~      Passive antibody therapy has been used with limited success in treating advanced HIV disease~     in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic~     donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced~     HIV-positive children.~   "
272664|NCT00000826|"~     To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in~     combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone~     in HIV-infected patients.~      Although prophylaxis for more than one opportunistic infection is emerging as a common~     clinical practice in patients with advanced HIV disease, little is known about possible~     adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic~     adverse interactions of the many combination prophylactic regimens that may be prescribed.~   "
273659|NCT00005728|"~     To utilize a community-based approach to nutrition education in an urban African American~     community.~   "
272665|NCT00000825|"~     The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus~     anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the~     immune system that fight infection) of at least 350 cells/mm3. This study will also examine~     the ability of antiretroviral therapy combined with IL-2 to boost the immune system.~      IL-2, given through injection under the skin, in combination with anti-HIV therapy can~     increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the~     safest and most effective dose to use.~   "
272666|NCT00000824|"~     To define the safety of cytotoxic T lymphocytes (CTLs) generated from sibling-supplied~     dendritic cells and lymphocytes and infused into an HIV-infected patient. To determine the~     efficacy of these CTLs in helping the immune system to fight HIV.~      With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and~     lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs~     generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the~     body to recognize HIV more readily and increase immune response against the virus.~   "
272667|NCT00000823|"~     To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine~     ( ddI ) alone and in combination, as well as in various sequences of administration.~      The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear;~     thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit~     pathogenicity.~   "
272668|NCT00000822|"~     To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected~     patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte~     proliferation, specific antibody responses, and DTH reaction. To describe the durability of~     the immunogen in patients who respond to the first 7 injections when they are boosted every 8~     weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To~     describe the ability of the immunogen to induce a response after an additional 6-12 months of~     injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT~     11/12/96: stratum 1 patients only].~      HIV-specific cellular immune responses appear to play an important role in HIV disease~     progression since both T helper and cytotoxic function against HIV decrease with disease~     progression.~   "
272669|NCT00000821|"~     To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin (~     interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To~     compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers.~      Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study,~     patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those~     with more advanced infections, and those with higher baseline CD4+ counts tended to derive~     the greatest benefit.~   "
272670|NCT00000820|"~     PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To~     determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus~     antiretroviral therapy alone.~      SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and~     antibody responses to protein and polysaccharide vaccines.~      The profound immune impairment that results from HIV-1 infection is due, at least in part, to~     the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and~     interferon-gamma. Antiretroviral agents do not directly address the problem of immune~     impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical~     immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1~     infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may~     provide an adjuvant effect on vaccine responses.~   "
272671|NCT00000819|"~     To determine the efficacy and safety of prednisone in patients with HIV-associated~     nephropathy. To determine the effects of prednisone on serum creatinine, urinary protein, and~     creatinine clearance.~      HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal~     insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in~     patients with advanced HIV disease. Little is known about the effects of corticosteroids on~     the progression of HIV disease. In light of the possible beneficial effects of~     corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is~     warranted.~   "
272672|NCT00000818|"~     PRIMARY: To determine the effect of 8 weeks of zidovudine (AZT) treatment on the HIV-1 burden~     in peripheral blood and lymphoid tissue in HIV-1-infected, AZT-naive patients with CD4+ T~     lymphocyte counts between 100 and 500 cells/mm3.~      SECONDARY: To determine the extent to which apoptosis (programmed cell death) occurs in these~     patients.~      In previous trials of AZT treatment in HIV-infected patients, an antiviral effect has been~     clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood~     mononuclear cells. However, the lymphoid tissues appear to be a major reservoir for HIV-1 and~     a major site of virus replication in HIV-infected persons. Further data is needed to assess~     the effect of treatment on viral burden and HIV-1 replication in lymphoid tissue.~   "
272673|NCT00000817|"~     To evaluate the separate and combined efficacy of a standardized acupuncture regimen and~     amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life~     of HIV-infected patients.~      Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses~     needles to relieve pain, have been used successfully to reduce pain in some people. It is not~     known how effectively these approaches relieve or reduce pain in patients with peripheral~     neuropathy secondary to HIV infection.~   "
272674|NCT00000816|"~     To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces~     the incidence of treatment-limiting adverse reactions compared to the routine initiation of~     the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients.~      Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP~     prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study~     in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose~     over 2 weeks, no significant adverse reactions have occurred.~   "
272698|NCT00000792|"~     To determine the safety and tolerance of daily oral hypericin when given to achieve target~     trough levels within defined cohorts. To determine the responses of surrogate markers of HIV~     infection to daily oral hypericin.~      It is not known whether daily oral dosing will produce a tolerable prolonged exposure to~     therapeutic levels of hypericin. Pharmacokinetic modeling studies have demonstrated that~     daily oral dosing should produce a trough level in a desired range without excessive peak~     levels.~   "
272675|NCT00000815|"~     To compare measles seroconversion rates (development of antibodies) at 13 months of age in~     HIV-infected and uninfected children on one of two immunization schedules: attenuated~     measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine~     (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months.~      Recommendations for the age at vaccination should balance the need to minimize the risk of~     morbidity and mortality with the benefit of achieving the highest seroconversion rates.~     Immunizing a more intact immune system at an earlier stage of HIV infection may in turn~     achieve better and long-lasting measles protection. This study will help define a more~     effective measles vaccine regimen for children diagnosed with HIV infection and will provide~     greater insight into the functional status of the HIV-infected children's humoral immune~     system.~   "
272676|NCT00000814|"~     To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of~     zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection.~      The duration of clinical benefit from zidovudine (AZT) may be limited because of development~     of viral resistance to the drug. Use of combination antiretroviral therapy can potentially~     reduce viral load and prevent emergence of multidrug resistance.~   "
272677|NCT00000813|"~     Part A: To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live~     canarypox recombinant vaccine (ALVAC gp160 MN) versus a recombinant canarypox expressing the~     rabies glycoprotein (ALVAC rabies glycoprotein) as a control in healthy, HIV-1 uninfected~     adult volunteers.~      Part B: To evaluate the schedule of two immunizations with ALVAC gp160 MN for optimal~     immunogenicity.~      Amendment: 12/22/93: To determine whether ALVAC gp160 MN in combination with SF-2 rgp120~     subunit protein is capable of generating humoral and cellular immune responses of greater~     intensity and longer duration than either vaccine administered alone.~      A canarypox-vectored vaccine (ALVAC) that expresses the gp160 antigen of the HIV-1 MN strain~     might satisfy many criteria for an affordable HIV vaccine. Per 12/22/93 amendment: Cellular~     responses have been augmented by the combination of two recombinant vaccines, especially in~     vaccinia naive individuals.~   "
272678|NCT00000812|"~     PRIMARY: To evaluate the safety, tolerability, and pharmacokinetics of daily oral~     thalidomide.~      SECONDARY: To examine the effect of thalidomide on antiviral activity and tumor necrosis~     factor-alpha (TNF-alpha) production, and the correlation between TNF-alpha inhibition and~     viral burden.~      A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in~     patients with HIV infection and may cause the body to produce more virus. In vitro studies~     have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV.~     However, more information on the pharmacological and immunological aspects of thalidomide is~     needed.~   "
272679|NCT00000811|"~     This study compares 2 different treatments administered to try to prevent serious bacterial~     infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin~     plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This~     study also evaluates the long-term safety and tolerance of these different drugs.~      SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However,~     the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP.~     This study compares the 2 treatments.~   "
272680|NCT00000810|"~     PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy.~     To compare the anti-HIV activity of three blood concentration levels of this agent with~     nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the~     reduction of HIV viral burden.~      SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug~     exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To~     assess anti-HIV activity using other disease markers.~      Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent~     and safe anti-HIV agents and may have different biological behavior than other currently~     available non-nucleoside RT inhibitors.~   "
272681|NCT00000809|"~     The purpose of this study is to test the safety and effectiveness of two different~     formulations of an HIV vaccine in infants born to HIV-infected women.~   "
272682|NCT00000808|"~     To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of~     nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to~     the mother during active labor, and when their neonates are dosed during the first week of~     life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who~     received nevirapine during active labor, and their neonates who received no dose, a single~     dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of~     life.~      Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic~     levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition,~     decreasing the neonate's risk of infection.~   "
272683|NCT00000807|"~     To assess the toxicity, tumor response rate, and effect on quality of life of daily low-dose~     etoposide administered for 7 consecutive days every other week in patients with AIDS-related~     Kaposi's sarcoma that has relapsed or progressed after systemic chemotherapy.~      Etoposide may be at least as, or even more, effective and less myelotoxic when given in low~     doses over prolonged periods of time.~   "
272684|NCT00000806|"~     PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two~     dose regimens and formulations of SC-52151.~      SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the~     relationship between day 14 plasma concentrations of SC-52151 and immunological and~     virological markers and toxicity.~      Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur~     in vitro after multiple passages, and since prolonged post infectious effects occur in vitro,~     comparison of two formulations, an elixir and a self-emulsifying drug delivery system~     (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.~   "
272685|NCT00000805|"~     PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral~     ganciclovir in HIV-infected infants, children, and adolescents.~      SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV.~      Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS~     patients is now standard therapy, but daily IV therapy can be complicated by catheter~     infections and thrombosis. An oral regimen of ganciclovir has been administered safely in~     adult AIDS patients and may be of significant benefit to children and infants as well.~   "
272687|NCT00000803|"~     To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in~     combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination.~      U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either~     AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy~     appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use~     of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in~     persons with HIV disease.~   "
272688|NCT00000802|"~     To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the~     onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected~     patients with CD4 counts <= 200 cells/mm3 or <= 15 percent of the total lymphocyte count who~     are intolerant to trimethoprim and/or sulfonamides.~      Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is~     associated with allergic manifestations and side effects that limit its use. Patients who are~     intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both~     shown promise as PCP prophylactic agents.~   "
272689|NCT00000801|"~     To estimate the response rate, overall and disease-free survival, toxicities, factors~     associated with outcome, and effect on quality of life in patients with AIDS-related primary~     CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and~     dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external~     beam irradiation. To determine other clinical markers present in this patient population.~      Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS~     lymphoma.~   "
272690|NCT00000800|"~     To determine whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT).~     To determine whether any such effect of methadone on disposition of AZT is time dependent and~     whether a metabolic interaction between AZT and methadone exists.~      Injection drug users represent an increasing proportion of HIV-infected persons. Since daily~     methadone maintenance is the major chemical treatment for injection drug abuse, it is~     important to determine the impact of methadone on AZT absorption, distribution, and~     elimination.~   "
272691|NCT00000799|"~     To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for~     treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the~     relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.~   "
272692|NCT00000798|"~     To evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1~     MN PND peptide for oral administration in healthy, HIV-1 seronegative adult volunteers at low~     risk for infection.~      Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite~     characteristics of an effective HIV vaccine, such as induction of mucosal immunity,~     production of cytotoxic T cells, and ease of administration. An oral microparticulate vaccine~     containing a prototype synthetic peptide has been developed. The microparticles can be~     degraded over time, inducing both secretory and systemic immune responses.~   "
272693|NCT00000797|"~     The Women's Interagency HIV Study (WIHS), a multicenter, prospective study, was established~     in August 1993 to carry out comprehensive investigations of the impact of HIV infection and~     its clinical, laboratory, and psychosocial effects in women. The purpose of this study is to~     collect and evaluate these data from HIV infected and at-risk women to better understand and~     provide support for women whom are currently HIV infected or who are at risk for HIV~     infection.~   "
272694|NCT00000796|"~     To determine the demographic, behavioral, clinical, and geographic risk factors associated~     with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the~     clinical and microbiological responses and overall survival of MDRTB patients who are treated~     with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per~     9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of~     patients who show failure or relapse are due to the same strain or reinfection with a new~     strain.~      Among TB patients, there has been an increase in progressive disease due to the emergence of~     antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify~     patients at high risk for MDRTB increases the hazard for both treatment failure and~     development of resistance to additional therapeutic agents. Efforts to improve survival in~     patients with MDRTB will depend on improved methods of assessing the risk of acquisition of~     MDRTB and identifying drug susceptibility patterns in a timely fashion.~   "
272695|NCT00000795|"~     To evaluate, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1~     peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched~     synthetic peptides from 15 viral strains representative of diverse worldwide isolates.~      Because there is considerable variation among HIV-1 virus strains from differing geographical~     locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent~     and divergent isolates, potentially providing for wide coverage of geographically isolated~     epidemics.~   "
272696|NCT00000794|"~     To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or~     sulfadiazine in AIDS patients with toxoplasmic encephalitis.~      AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of~     sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an~     antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in~     preclinical testing has been well tolerated, is now available as a suspension, which is more~     readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in~     combination with sulfadiazine or pyrimethamine will be studied.~   "
272697|NCT00000793|"~     To assess the efficacy, safety, and tolerability of amitriptyline hydrochloride versus~     mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful~     peripheral neuropathy.~      No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related~     neuropathy have been attempted. Both amitriptyline and mexiletine have been useful in the~     management of painful neuropathies; however, both are associated with certain toxicities. In~     this comparative study of amitriptyline and mexiletine, benztropine mesylate also will be~     included as an active placebo to mimic the side effects of the study drugs.~   "
273069|NCT00015002|"~     A course of steroids given to a mother who is in labor with a premature fetus will reduce the~     risk of the premature infant dying or having serious complications. This trial will test~     whether more than one course of antenatal steroids is more beneficial or risky to the infant~     than a single course.~   "
272699|NCT00000791|"~     To determine the safety and anti-HIV activity of two doses of SC-49483 in combination with~     zidovudine (AZT) versus AZT alone. To determine the influences of viral phenotype on the~     anti-HIV activity of these treatment regimens.~      SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to~     SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less~     gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the~     benefits of both drugs in patients with HIV infection.~   "
272700|NCT00000790|"~     PRIMARY: To evaluate the effectiveness and safety of thalidomide for treatment of oral and~     esophageal aphthous ulcers (those unrelated to a known infection or malignancy) in patients~     with advanced HIV disease. To evaluate the effect of thalidomide on HIV load in this patient~     population. Per 06/28/94 amendment, to evaluate the effectiveness of thalidomide in~     preventing recurrences in patients whose aphthae completely heal at the end of acute~     treatment.~      SECONDARY: To evaluate the effect of thalidomide on blood tumor necrosis factor (TNF) levels~     and to obtain pharmacokinetic data on the drug. Per 06/28/94 amendment, to evaluate the~     safety of thalidomide. Per 05/10/95 amendment, to explore in a substudy the effects of~     thalidomide on idiopathic genital aphthous ulcers in HIV-infected women.~      Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in~     malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe~     forms of aphthous ulceration in AIDS patients.~   "
272701|NCT00000789|"~     PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral~     stavudine (d4T) in symptomatic HIV-infected children.~      SECONDARY: To compare the clinical, virologic, and immunologic responses between the two~     treatment groups, and to obtain pharmacokinetic data for both drugs.~      At present, AZT is considered the drug of choice for initial treatment of most children with~     HIV infection, although disease progression or drug intolerance is associated with its~     long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well~     tolerated, although an optimum dose has not been determined.~   "
272702|NCT00000788|"~     To evaluate the pharmacokinetics and safety of concomitant administration of methadone and~     fluconazole.~      Injection drug users constitute the second largest subset of the U.S. population at risk for~     HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of~     methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal~     candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could~     result in symptoms of methadone withdrawal or overdose in patients taking the drugs in~     combination.~   "
272703|NCT00000787|"~     PRIMARY: To identify factors associated with risk of HIV infection through heterosexual~     activity among urban, inner-city women.~      SECONDARY: To identify correlates of high-risk behaviors in order to provide a basis for~     future intervention studies.~   "
272704|NCT00000785|"~     PRIMARY: To estimate the proportion of tuberculosis patients in the CPCRA who have~     drug-resistant tuberculosis (TB) and to describe the patterns of drug resistance.~      SECONDARY: To compare drug resistance data on the Mycobacterium tuberculosis isolates of~     HIV-infected patients to those of HIV-uninfected patients who are being followed in the~     CPCRA. To assess the relationship of resistance data with geographic, demographic, and HIV~     and TB risk factor information.~      Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent~     and associated with the concurrent HIV epidemic. The total number of CPCRA patients who will~     develop, or who have experienced, confirmed TB is unknown. It is critical to determine the~     depth and breadth of the current problem of drug-resistant TB.~   "
272705|NCT00000784|"~     To examine, in patients enrolled in protocols CPCRA 006 and/or 007, the relationship between~     patient compliance and demographic, psychosocial, and lifestyle characteristics and Health~     Belief Model premises (i.e., patient's perception of susceptibility to and severity of~     disease and perception of benefits and barriers to a particular treatment) in order to design~     more effective intervention protocols.~      Patient noncompliance can influence the statistical findings of a clinical study, possibly~     resulting in an incorrect assessment of the effects of the investigational therapeutic agent.~     Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical~     research do not typify those traditionally included in clinical trials or compliance~     research, it is necessary to elucidate and examine the special needs of these populations and~     to determine the extent to which these needs manifest themselves as potential barriers to~     protocol compliance.~   "
272706|NCT00000783|"~     PRIMARY: To identify sexual behaviors and biological factors associated with an increased~     risk of heterosexual HIV transmission.~      SECONDARY: To assess the effect of safer sex counseling on behavior of sexually active~     heterosexuals in which one member of the couple is infected with HIV. To create a repository~     of serum, peripheral blood mononuclear cells, semen, and cervico-vaginal washings from~     heterosexual couples who are concordant (both partners HIV infected) and discordant (one~     partner HIV infected) with respect to HIV infection.~      In the United States, the number of AIDS cases attributed to heterosexual transmission,~     although still a small percentage of the total number of reported cases, is the most rapidly~     growing category. The rate at which HIV is transmitted between heterosexual couples and the~     factors that may impede or enhance heterosexual transmission are important to understanding~     and slowing the worldwide HIV epidemic.~   "
272707|NCT00000782|"~     To determine the frequency of delayed-type hypersensitivity (DTH) reactions in HIV-positive~     patients to two doses of two envelope glycoprotein antigens prepared differently. To~     determine whether patients who have previously demonstrated a DTH response to intradermal~     MGStage HIV-1 gp160 IIIB baculovirus (MicroGeneSys) have a reproducible response to a repeat~     injection of gp160 and whether there is cross-reactivity to intradermal HIV-1 rgp160 IIIB~     vero cell expressed (Immuno-AG).~      PER 4/5/95 AMENDMENT: To also determine whether patients who respond to HIV-1 rgp160 IIIB~     baculovirus (MicroGeneSys) have cross-reactivity to intradermal skin tests of HIV-1 rgp160 MN~     (Immuno-AG).~      Previous studies in individuals immunized with gp160 suggest that a skin test response in~     immunized patients can be used as a surrogate marker for new proliferative and cytotoxic~     responses induced by vaccination.~   "
272985|NCT00018148|"~     Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco~     withdrawal symptoms and increases long term cessation rates when combined with transdermal~     nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized,~     parallel group trial in which smokers aged 18-70 will be subject to the combination of oral~     and patch treatments.~   "
272708|NCT00000781|"~     To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT~     plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in~     HIV-infected patients with advanced disease.~      The rapid emergence of resistant HIV strains has been observed in patients receiving~     monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use~     of combination therapy with two nucleoside drugs or convergent combination therapy with two~     nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant~     HIV strains. Since toxicity is a major problem in patients with advanced disease who are~     receiving combination nucleoside therapy, alternating the two drugs may provide a way of~     retaining several benefits of combination therapy while minimizing the increased toxicity.~   "
272709|NCT00000780|"~     PRIMARY: To identify, characterize, and co-enroll HIV-infected adolescents into existing and~     future ACTG (or other NIH-sponsored) HIV treatment protocols through the systematic and~     recurrent assessment of eligibility. To assess the ability of adolescents enrolled in ACTG~     220 to adhere to ACTG (or other NIH-sponsored) HIV treatment protocols; and to define factors~     that influence the adolescent's ability to enter or adhere to study protocols.~      SECONDARY: To describe the nature, stage, and progression of HIV infection in adolescents.~      Little is known about HIV-infected adolescents as a group and, as a result, small numbers of~     them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage~     enrollment of HIV-infected adolescents whose socio-demographic profile has made access to~     NIH-sponsored research unlikely.~   "
272710|NCT00000779|"~     PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens~     versus control in HIV-infected individuals with CD4 counts greater than or equal to 500~     cells/mm3.~      SECONDARY: To determine whether significant advantages to any one vaccine exist.~      Before large clinical trials of anti-HIV vaccines are undertaken, it is important to~     determine whether there are significant advantages to any one of the vaccines currently~     offered for such studies.~   "
272711|NCT00000778|"~     To evaluate the methodology for rapidly determining the early bactericidal activity (EBA),~     tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary~     tuberculosis (TB).~      Traditionally, in trials for treatment of TB, a new drug is administered in combination with~     two or more other antituberculous agents of known effectiveness over a long period of time.~     In this setting, it is difficult to determine the effect of any single drug or dose level.~     Development of new agents for the treatment of TB may be accelerated by a methodology in~     which a new agent could be evaluated for activity by administering it as a single agent over~     a short time period. This study utilizes a method to measure the amount of bacteria present~     each day in the lungs.~   "
272712|NCT00000777|"~     To evaluate the safety of gp160 vaccine (VaxSyn) in HIV-1 infected pregnant women with CD4~     counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and~     the passive acquisition of vaccine-specific antibody in their infants.~      Evidence suggests that an advanced stage of disease with high plasma viremia is associated~     with increased transmission of HIV-1 to the fetus. Slowing the progression of disease,~     reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody~     are potentially attainable goals through active immunization of the mother during pregnancy.~   "
272713|NCT00000776|"~     To evaluate the effect of corticosteroids on reducing elevated intracranial pressure in~     cryptococcal meningitis. To evaluate the safety of corticosteroids in patients with~     cryptococcal meningitis and intracranial hypertension.~      In AIDS patients with cryptococcal meningitis, a correlation has been found between early~     death and elevated intracranial pressure. Since dexamethasone has been found to reduce~     intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS~     patients with cryptococcal meningitis.~   "
272714|NCT00000775|"~     To determine the safety, immunogenicity, and optimal dose of rgp120/HIV-1MN octameric V3~     peptide vaccine (SynVac) in healthy volunteers.~      It is likely that the ultimate control of AIDS will depend on the development of safe and~     effective vaccines against HIV-1. SynVac is a synthetic candidate vaccine based on eight~     V3-derived peptides attached to a heptalysyl core to form radial octamers. In animal studies,~     the vaccine appears safe and demonstrates the capability for producing immune responses.~   "
272715|NCT00000774|"~     PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech)~     and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to~     HIV-infected women. To evaluate changes in viral load in infants proven to be infected and~     absolute CD4 counts in all immunized infants.~      SECONDARY: To evaluate the immunogenicity of these envelope recombinant proteins in infants~     of indeterminate HIV status born to HIV-infected women.~      Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early~     sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may~     enhance HIV-specific immune function to alter HIV replication and disease progression.~   "
272716|NCT00000773|"~     To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate~     suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94~     amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally~     exposed (per 8/9/95 amendment) infants and children who are at risk of developing~     Pneumocystis carinii pneumonia (PCP).~      Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly~     absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has~     been prepared as a microparticulate suspension. Since studies in adults have demonstrated~     substantial safety of this drug, evaluation in children is being pursued.~   "
272717|NCT00000772|"~     To evaluate the safety and tolerance of concurrent administration of standard-dose didanosine~     (ddI) with low-dose ribavirin in HIV-positive patients. To determine the pharmacokinetic~     interactions of concurrent administration of ddI and ribavirin and correlate pharmacokinetic~     parameters with toxicity. To investigate antiviral activity of the combined regimen.~      Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination~     antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT).~   "
273000|NCT00017953|"~     The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term~     effects of a lifestyle intervention designed to achieve and maintain weight loss. The study~     will investigate the effects of the intervention on heart attacks, stroke and~     cardiovascular-related death in individuals with type 2 diabetes who are also overweight or~     obese.~   "
272719|NCT00000770|"~     To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI~     combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV~     activity data using immunologic and virologic markers.~      Previous in vitro studies suggest that HIV that has already developed resistance to AZT and~     ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase~     inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected~     patients may prove more effective.~   "
272720|NCT00000769|"~     To determine the safety and tolerance of interleukin-4 (IL-4) in patients with AIDS-related~     Kaposi's sarcoma. To determine the effects of IL-4 on tumor growth in patients with~     AIDS-related Kaposi's sarcoma.~      IL-4 exhibits a variety of beneficial effects on the immune system and is a potent inhibitor~     of Kaposi's sarcoma cells in vitro.~   "
272721|NCT00000768|"~     To determine the oral bioavailability of three dose levels of oral ganciclovir given with and~     without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to~     compare the bioavailability of these regimens to that of standard intravenous (IV)~     ganciclovir.~      Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis~     following induction treatment. Oral ganciclovir is a likely candidate for maintenance because~     of its possible therapeutic value and ease of administration, but an optimum dose has not~     been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an~     acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal~     absorption of this drug.~   "
272722|NCT00000767|"~     To evaluate, in healthy HIV-1 seronegative vaccinia-immune and vaccinia-naive volunteers, the~     safety and immunogenicity of an HIV-1 candidate vaccine (TBC-3B) consisting of a live~     recombinant vaccinia virus expressing the env, gag, and pol genes of HIV-1 IIIB strain. To~     evaluate the potential of boosting with one of a variety of HIV-1 recombinant subunit,~     peptide, or pseudovirion vaccines, if available, to augment the immune responses of the~     vaccinees.~      Antigenic drift, defined as the genetic variation of the HIV-1 envelope gene that results in~     antigenic variation during natural infection, may confound attempts to achieve protective~     immunity using a vaccine based solely on HIV-1 envelope proteins. Inclusion of conserved core~     and polymerase proteins along with envelope protein in a candidate vaccine may address some~     of the problems with antigenic variability. A prime-boost immunization approach using a novel~     priming immunogen expressing env, gag, and pol genes of the HIV-1 IIIB strain will be~     attempted in this study.~   "
272723|NCT00000766|"~     To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or~     the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis.~      Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of~     patients treated, relapses are common and may accelerate due to development of drug~     resistance, deteriorating immune function, or other factors. Treatment strategies currently~     being investigated include switching patients from one drug to the other or combining the two~     drugs.~   "
272724|NCT00000765|"~     To evaluate the safety and efficacy of early treatment with zidovudine for preventing a~     decline in CD4+ lymphocyte counts in patients with primary HIV infection. To determine the~     natural history of virologic and immunologic changes in primary HIV infection.~      Previous studies indicate that intervention with zidovudine during primary HIV infection~     could reduce the initial viral burden and subsequent decline in immune functions, and could~     prolong not only the time to development of AIDS but also the time to initiation of chronic~     antiretroviral therapy.~   "
272725|NCT00000764|"~     PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in~     combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in~     efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention~     (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous~     intraepithelial lesions ( SIL ) in patients with HIV infection.~      SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a~     on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels.~      Patients with HIV infection have a significant risk of recurrence following local ablation of~     intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important~     cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of~     non-HIV-infected subjects have established that synthetic retinoids inhibit the progression~     of epithelial preneoplastic conditions and some neoplastic states.~   "
272726|NCT00000763|"~     To assess toxicity and determine the MTD of intravenous TNP-470 administered weekly in~     patients with AIDS-related Kaposi's sarcoma. To assess pharmacokinetics and tumor response of~     the drug.~      Since evidence shows that neovascularization is important in the development of Kaposi's~     sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with~     the disease.~   "
272727|NCT00000762|"~     To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN~     (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1~     month to 18 years of age.~      The initiation of this immunotherapy trial will provide multiple benefits by assessing in~     asymptomatic HIV-infected children a therapy currently being tested in their adult~     counterparts, in the hope of forestalling the progression of HIV immunosuppression and~     clinical disease.~   "
272728|NCT00000761|"~     PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma~     ) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine ( ddI )~     therapy. To document HIV-associated defects in neutrophil and/or monocyte function that are~     improved with rIFN-gamma.~      SECONDARY: To determine whether a change in CD4 cell count occurs and to assess virologic~     status and effects on AZT and ddI pharmacokinetics.~      It is likely that infants and children severely immunocompromised by HIV infection would~     respond to immunomodulators that augment different portions of the host defense system.~     Interferon-gamma has been shown to benefit children with severely compromised nonspecific~     immunity and may thus be of benefit to those with HIV infection.~   "
272951|NCT00018590|"~     This is a working registry of a longitudinal cohort of Hispanics, Native Americans, and~     non-Hispanic whites (as controls) for tracking of vascular disease endpoints. Blood samples~     collected for ongoing pilot projects as well as specimen banking. Pilot studies are~     observational and involve risk measures for stroke, atherosclerosis, and vascular~     inflammatory responses. Questionnaires on demographics, risk factors, and vascular disease~     history are performed. No interventions proposed as yet.~   "
272729|NCT00000760|"~     To study the anti-HIV activity of the various doses of Ro 24-7429 monotherapy based on~     virologic and immunologic endpoints. To study the safety and tolerance of Ro 24-7429. To~     explore relationships between exposure to Ro 24-7429 and its metabolites and antiviral~     activity and drug toxicity. To determine a safe, tolerable, and active dose regimen of Ro~     24-7429, and to make preliminary observations of Ro 24-7429 in combination with another~     antiretroviral nucleoside.~      The HIV genome contains a number of genes that regulate viral replication. Control of the~     activity of these genes and their encoded proteins represents a potential target for~     development of new antiretroviral drugs. The tat (transactivator of transcription of HIV)~     antagonist Ro 24-7429 is the first compound for clinical testing that utilizes this approach~     for therapy of HIV infection.~   "
272730|NCT00000759|"~     AS PER AMENDMENT 10/24/96: To develop a domain/construct-driven neuropsychological and~     neurological battery. Scaling of instruments to allow measurement of functions from infancy~     to early adulthood; establish reliability and validity of the new instruments developed for~     the NIMH Neurodevelopmental Battery. Downward extension of cognitive domains into infancy and~     early childhood. To describe and compare outcomes when assessing level of development versus~     rate of change. Describe and compare the outcomes from a global assessment of~     neurodevelopment (e.g., a standardized I.Q. score) versus discrete assessments (e.g.,~     functional domains such as motor or language skills). Develop guidelines for multicultural~     neuropsychological and neurological assessment within a clinical trials design. Describe the~     nature of impaired developmental abilities and course of the disease in infants and children.~      The assessment of children who sustain central nervous system (CNS) insult requires~     approaches that differ in several ways from adult-based assessment. The rapid changes that~     occur in the developing CNS as well as in behavior reflect underlying processes of growth and~     development.~   "
272731|NCT00000758|"~     To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis~     in HIV-infected women who have received standard ablative therapy (surgery) for high-grade~     cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To~     correlate time to recurrence of cervical dysplasia with T-cell function.~      Women with HIV infection are at greater risk for cervical dysplasia. Because of the~     likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer,~     there is an urgent need to develop appropriate therapies.~   "
272732|NCT00000757|"~     To evaluate the safety and immune response to 160 mcg HIV-1 recombinant envelope glycoprotein~     gp160. To evaluate the duration of antibody response and its relationship to dose and~     frequency of inoculation.~      Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate~     that, although serum anti-gp160 antibody responses were detected, the level and duration of~     those responses were limited. A preliminary observation suggests that weak functional~     antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a~     dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.~   "
272733|NCT00000756|"~     To determine the safety, tolerance, and feasibility of adoptive immunotherapy with autologous~     cytotoxic T-lymphocytes (CTLs) in HIV-infected patients with CD4 counts between 100 and 400;~     to evaluate the immunologic, virologic, and clinical changes for up to 24 weeks following~     infusion of study therapy.~      Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently~     lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors~     encoding HIV-1-specific proteins. Administration of these cytotoxic T lymphocytes (CTLs) may~     help prevent HIV disease progression.~   "
272734|NCT00000755|"~     To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen.~     To determine the effect of antiretroviral therapy on vaccine responsiveness.~      Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been~     hypothesized that HIV-specific immune responses are responsible for the period of relative~     quiescence of viral replication. Recent studies suggest that these immune functions can be~     augmented by vaccination with HIV-derived antigens.~   "
272735|NCT00000754|"~     To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in~     combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with~     HIV infection and CD4 count < 400 cells/mm3.~      AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN~     alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites~     of viral replication may improve HIV inhibition and produce more effective and sustained~     anti-HIV effects.~   "
272736|NCT00000753|"~     To determine the safety, toxicity, pharmacokinetic profile, and antiretroviral activity of~     atevirdine mesylate ( U-87201E ) in HIV-infected patients. Per 06/04/93 amendment, to also~     evaluate the interactive effects of didanosine ( ddI ) or zalcitabine ( dideoxycytidine; ddC~     ) with zidovudine ( AZT ) on the pharmacokinetics of U-87201E and to assess the effects of~     the triple combination therapies on immunologic and virologic parameters.~      Since the use of non-nucleoside reverse transcriptase inhibitors such as U-87201E has been~     associated with the rapid development of resistant HIV isolates, an initial evaluation of~     this drug in patients was made in combination with AZT. Because of the inability to detect~     resistance after 6 weeks of combined AZT/U-87201E therapy, this protocol will initially~     investigate U-87201E administered alone and then investigate the effect of this drug with AZT~     and ddI or ddC.~   "
272737|NCT00000752|"~     To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone~     dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant (~     Deconsal II ) alone, when these agents are given individually or in combination for the~     prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare~     the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the~     evaluation and management of HIV-infected patients with recurrent paranasal sinus infection.~     To determine relevant prognostic factors and the microbiologic etiology of maxillary~     sinusitis in this patient population.~      Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory~     to traditional therapy, particularly in patients with advanced immunosuppression. An~     intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears~     to be warranted.~   "
272952|NCT00018577|"~     This program aims to investigate factors associated with development of parkinsonism or~     idiopathic Parkinson's Disease in an ongoing cohort of patients established in 1965 who are~     currently undergoing their sixth examination.~   "
272738|NCT00000751|"~     To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin~     (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT)~     administered intrapartum and to the newborn, on incidence of HIV infection in infants born to~     HIV-infected women who received AZT during pregnancy for medical indications.~      Vertical transmission of HIV from mother to child may occur before, during, or after~     parturition (via breast-feeding). It is believed that therapy administered both during~     pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive~     short-term antiretroviral therapy for the newborn, following the intensive viral exposure~     presumed to occur at birth, may be necessary.~   "
272739|NCT00000750|"~     Primary: To determine the efficacy of early treatment with zidovudine (AZT) in HIV-infected~     asymptomatic infants. To determine the safety and tolerance of AZT in this patient~     population.~      Secondary: To compare the virologic and immunologic parameters between the treatment groups.~     To determine the efficacy of AZT as an early treatment to prevent development of CD4+ cell~     depletion in HIV-infected asymptomatic infants.~      AZT is currently indicated for primary treatment in children with HIV-associated signs and~     symptoms and for those with significant immunodeficiency. This study will attempt to~     determine whether early treatment with AZT prevents the development of symptoms in~     HIV-infected infants who are asymptomatic.~   "
272740|NCT00000749|"~     To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate~     vaccine in MF59 emulsion without MTP-PE at 0, 1 and 6 months.~      Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol~     VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.~   "
272741|NCT00000748|"~     To compare the safety and efficacy of two dosage regimens (daily and thrice-weekly) of~     sulfamethoxazole/trimethoprim (SMX/TMP; TMS) in the prevention of Pneumocystis carinii~     pneumonia (PCP) in high-risk HIV-infected patients.~      Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of~     PCP and may be effective in preventing PCP in patients who have never developed it. Because~     SMX/TMP can cause side effects, this study will attempt to determine the safest and most~     effective dose of this combination.~   "
272742|NCT00000747|"~     Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected~     individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts~     greater than or equal to 500 cells/mm3.~      Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent~     nevirapine is associated with rapid emergence of resistance when administered alone or in~     combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In~     persons with less advanced HIV disease and less viral burden, the emergence of resistance may~     be delayed, thus permitting evaluation for beneficial effect in a population where there is~     currently no established therapy.~   "
272743|NCT00000746|"~     Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160~     envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit~     recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity~     compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts~     with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two~     priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity~     of the three subunit vaccines when administered as boosters.~      Secondary: To examine the safety of administering the individual subunit vaccines in~     combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone.~      In a previous study of candidate HIV vaccines, the evidence suggested that administration of~     a booster vaccination with a different vaccine preparation may produce a better immune~     response than administration of HIVAC-1e vaccine alone.~   "
272744|NCT00000745|"~     To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To~     determine the immunogenicity of gp160.~      Although recent advances have been made in antiviral therapy against AIDS, there is currently~     no cure. It is likely that ultimate control of the disease will depend on the development of~     safe and effective vaccines against HIV.~   "
272745|NCT00000744|"~     To compare the efficacy of fluconazole versus placebo for the prevention of Candida~     esophagitis and vaginal/oropharyngeal candidiasis, including a comparison of the development~     of clinical resistance.~      Fluconazole has been shown to be effective in preventing or suppressing candidiasis in~     HIV-negative women. An increasing likelihood of oral and esophageal candidiasis in~     conjunction with progressive immunosuppression raises the question of the potential role of~     prophylactic antifungal therapy in high-risk persons.~   "
272746|NCT00000743|"~     To determine the safety and tolerance of alvircept sudotox (sCD4-PE40) given at various~     dosing intervals and concentrations. To determine whether frequent dosing alters~     immunogenicity or toxicity. To obtain preliminary data to ascertain whether sCD4-PE40 has~     activity against HIV in human subjects. To determine whether there is any additive toxicity~     with combined use of sCD4-PE40 and zidovudine (AZT).~      There is some evidence that AZT and sCD4-PE40, an experimental drug with anti-HIV activity~     previously demonstrated in vitro, may produce increased benefit when used in combination in~     HIV-infected patients.~   "
272747|NCT00000742|"~     Part I: To determine the pharmacokinetic dose for atevirdine mesylate ( U-87201E ) when used~     in combination with zidovudine ( AZT ). To determine the pharmacokinetic profiles of U-87201E~     and AZT over a 12-week period.~      Part II: To determine whether or not decreased viral susceptibility to U-87201E develops when~     the drug is administered concomitantly with AZT for 12 weeks.~      Part III: To evaluate the pharmacokinetic effects of ddI/AZT/U-87201E therapy and to assess~     changes in viral susceptibility to U-87201E.~      Interest exists in the development of antiretroviral agents that possess different mechanisms~     of action from nucleoside analogs such as AZT. U-87201E is a non-nucleoside reverse~     transcriptase (RT) inhibitor that has demonstrated activity against HIV-1; however, an~     emerging characteristic of non-nucleoside RT inhibitors is the development of rapid~     resistance to HIV isolates. Whether this resistance can be prevented in the presence of~     nucleoside analogs such as AZT and ddI has yet to be determined.~   "
272748|NCT00000741|"~     To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients~     with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or~     absence of respiratory failure at the time of randomization to the study.~   "
272749|NCT00000740|"~     To determine the maximum tolerated dose (MTD) of WR 6026 in HIV-infected patients. To~     determine whether any unexpected toxicities are caused by WR 6026 in HIV-infected patients.~     To determine whether there is additional toxicity when WR 6026 is given for 21 days rather~     than 14 days. To further investigate the pharmacokinetics and pharmacodynamics of WR 6026,~     and in particular to examine potential correlations between the area under the~     concentration-time curve and methemoglobinemia or other toxicities.~      In recent animal studies, WR 6026 demonstrated inhibitory activity against Pneumocystis~     carinii pneumonia (PCP). This study will assess the safety and tolerance of this drug in~     HIV-infected patients who do not have PCP.~   "
272750|NCT00000739|"~     Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and~     children; to study the pharmacokinetics of orally administered dapsone in HIV-infected~     infants and children.~      Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP )~     breakthrough in children receiving two different dose regimens of dapsone.~      Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected~     children considered to be at high risk. Approximately 15 percent of children are intolerant~     to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many~     children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second~     choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been~     established.~   "
272751|NCT00000738|"~     PRIMARY: To assess the safety of nimodipine in the treatment of HIV-Associated Motor /~     Cognitive Complex (formerly AIDS dementia complex). To assess the systemic or central nervous~     system toxicities (e.g., rash, headache, gastrointestinal symptoms, nausea, dyspnea, muscle~     pain or cramp, acne) of nimodipine.~      SECONDARY: To assess the efficacy of nimodipine in stabilizing the progression of~     HIV-Associated Motor / Cognitive Complex by improvement in neuropsychological test~     performance, peripheral neuropathy, or other neurologic manifestations.~      HIV-infected patients may develop a condition known as HIV-Associated Motor / Cognitive~     Complex (also known as AIDS dementia complex) that causes damage to the nervous system,~     particularly the brain and spinal cord. Evidence exists that nimodipine protects nerve cells~     in culture from injury by HIV. Although nimodipine has been used in patients with other~     neurological problems, its safety and effectiveness in halting the progression of~     HIV-Associated Motor / Cognitive Complex is not yet known.~   "
272752|NCT00000737|"~     To obtain data on the safety of administering megestrol acetate and dronabinol as single~     agents or in combination to patients with human immunodeficiency virus (HIV)-wasting~     syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy~     with megestrol acetate and dronabinol with regard to weight gain, appetite increase and~     quality of life in this patient population. To obtain steady-state pharmacokinetics data when~     megestrol acetate and dronabinol are administered as single agents and in combination.~      HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight~     loss, is of particular concern because it can exacerbate the primary illness and is~     associated with a poor prognosis. Attempts at maintaining body mass through the use of~     megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.~   "
272753|NCT00000736|"~     To determine if treatment with zidovudine (AZT) will delay or prevent the onset of AIDS or~     AIDS related complex (ARC) in individuals infected with HIV but who do not have symptoms of~     AIDS or ARC. Also, to compare the dose of AZT found to be useful in AIDS and severe ARC with~     a lower dose to see if side effects can be reduced.~      Results from several studies show that a high percentage of people infected with HIV will~     eventually develop AIDS or ARC unless an effective treatment is found. Because AZT is known~     to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in~     advanced disease, it is reasonable to try it in less advanced cases.~   "
272754|NCT00000735|"~     To determine the safety of intravenous infusion of ampligen in symptomatic HIV-infected~     patients at several dose levels, to determine the maximum dose that can be tolerated, and to~     measure the effects of ampligen on the HIV virus infection, immune function, and clinical~     condition. Ampligen is a suitable drug for clinical trials against HIV because it has been~     shown to stimulate the immune system and to inhibit replication of HIV in vitro at doses that~     can be achieved without noticeable harmful side effects.~   "
272755|NCT00000734|"~     To determine if the pharmacokinetics of high doses of zidovudine (AZT) (that is, how fast AZT~     reaches the blood, what concentration of AZT is attained in the blood, and how long AZT~     remains in the blood) changes from day to day in the same patient. Also to determine whether~     the pharmacokinetics of AZT is changed when trimethoprim/sulfamethoxazole (SMX/TMP) is given~     at the same time, or whether the pharmacokinetics of SMX/TMP is altered by AZT given at the~     same time.~      AZT has been effective in treating HIV infection in some patients with AIDS, and SMX/TMP is~     an antibiotic combination which is useful in preventing or treating Pneumocystis carinii~     pneumonia (PCP). It is important to know how drugs interact in patients because addition of a~     second drug may change the speed at which a drug is eliminated from the body, and cause~     increased toxic effects or decreased therapeutic effects.~   "
272756|NCT00000733|"~     To determine how fast ribavirin reaches the bloodstream, what concentration of ribavirin is~     reached in blood and how long it remains in the blood (pharmacokinetics) when given by~     different routes of administration. To find the maximum tolerated dose (MTD) of ribavirin.~     The effects of ribavirin on the immune system, and on the virus will be measured by T4 cell~     count and p24 antigen levels.~      Early studies with ribavirin in patients with AIDS and AIDS related complex (ARC) have shown~     that ribavirin appears to inhibit the spread of the virus. Determination of how much and how~     often to give the drug will require further knowledge of the pharmacokinetics and toxicity of~     the drug in patients with AIDS or ARC and in chronic virus carriers who do not have symptoms.~   "
272771|NCT00000718|"~     To determine if alternating zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) (first~     one and then the other) or intermittent therapy (1 week of drug then 1 week off) will lessen~     the toxic effects of either drug alone, while still inhibiting HIV (the AIDS virus) in~     patients with AIDS or AIDS related complex.~      AZT extends the survival of some patients with AIDS, and both AZT and ddC are known to~     inhibit the growth of HIV. When AZT or ddC is given continuously over a prolonged period of~     time, toxic effects occur that are not found when the drugs are given for 4 - 6 weeks. It is~     hoped that by alternating the drugs or by giving one drug intermittently, the toxic effects~     can be decreased without lowering the therapeutic effectiveness of the drugs.~   "
272757|NCT00000732|"~     To determine if the pharmacokinetics of low doses of zidovudine (AZT) (that is, how fast AZT~     reaches the blood, what concentration of AZT is attained in the blood, and how long AZT~     remains in the blood) changes from day-to-day in the same patient. Also to determine whether~     the pharmacokinetics of AZT is changed by sulfamethoxazole/trimethoprim (SMX/TMP) given at~     the same time or whether the pharmacokinetics of SMX/TMP is altered by AZT therapy. AZT has~     been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination~     which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an~     important cause of disease and death in patients with AIDS. It is important to know how drugs~     interact in patients because addition of a second drug may change the speed at which a drug~     is eliminated from the body, and cause increased toxic effects or decreased therapeutic~     effects.~   "
272758|NCT00000731|"~     To determine if zidovudine (AZT) and acetaminophen (APAP) interact when given to the same~     patient, and if so, the manner of interaction. Patients with AIDS often require therapy with~     painkillers for the management of mild pain and discomfort associated with their disease, and~     APAP is often prescribed. AZT is being used to treat AIDS patients. It is important for~     doctors to understand how AZT and APAP may interact when given to the same patient, because~     other studies have suggested that the dosage of AZT may have to be adjusted when given with~     APAP in order to avoid or minimize adverse effects.~   "
272759|NCT00000730|"~     This study compares three different therapies for treatment of refractory Pneumocystis~     carinii pneumonia (PCP) in patients with AIDS. Refractory means that the patient has failed~     to respond to at least 4 days of treatment with either of two standard therapies: (1)~     sulfamethoxazole/trimethoprim (SMX/TMP) or (2) pentamidine (PEN). This study compares therapy~     with trimetrexate (TMTX) and leucovorin (LCV) to standard therapy and standard therapy plus~     high-dose steroids (methylprednisolone). The purpose is to find better and safer forms of~     treatment for PCP in AIDS patients. There is at present no scientific information about the~     best treatment for an AIDS patient with PCP who is not improving while receiving the standard~     therapies (SMX/TMP or PEN). New drug treatments are available, including steroid therapy and~     TMTX, but there is no information proving that these new treatments work better than the~     standard therapies.~   "
272760|NCT00000729|"~     To determine the toxicity of low dose foscarnet administered for 4 weeks to HIV infected~     patients who are asymptomatic, have AIDS, or other HIV associated conditions and a CD4+~     lymphocyte count < 500 cells/mm3. To obtain preliminary efficacy data. Although zidovudine~     (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many~     patients and other means of treating HIV-infected persons need to be evaluated. In vitro~     (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and~     that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment~     of HIV-infected individuals with foscarnet during an early phase of HIV infections will~     reduce the risk of developing AIDS.~   "
272761|NCT00000728|"~     To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with~     increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent~     generalized lymphadenopathy syndrome ( PGL ). The effects to be studied include safety or~     toxicity, how quickly the drugs are used in the body, effects on the immune system, effects~     on HIV, concentrations in body fluids, and how quickly the drugs are cleared by the kidneys.~     The trial will establish the maximum tolerated dose ( MTD ) and will be a pilot study to~     determine the dose that has the greatest effect in the immune system.~      AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase~     immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also~     been effective in treating Kaposi's sarcoma in a number of patients. Because of the clinical~     activities of these two drugs and because their toxicities and mechanisms of action do not~     overlap, it may be beneficial to combine the two drugs with their antiviral and immune~     stimulatory effects.~   "
272762|NCT00000727|"~     To determine if the drug combination sulfamethoxazole-trimethoprim (SMX-TMP), given by mouth,~     and the drug pentamidine (PEN), given by inhaled aerosol, are effective in preventing a~     relapse of Pneumocystis carinii pneumonia (PCP) when they are given to patients who have~     recovered from a first episode of PCP and are being given zidovudine (AZT) to treat primary~     HIV infection.~      AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic~     infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT,~     indicating a need for other treatments to reduce the relapse rate.~      The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been~     partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT~     with these medications will be more effective than AZT or one of the medications alone.~   "
272763|NCT00000726|"~     To explore the safety and usefulness of foscarnet, an antiviral agent, in the treatment of~     cytomegalovirus (CMV) retinitis. Untreated CMV retinitis is a rapidly progressive, blinding~     disease in AIDS patients. The manner in which foscarnet breaks down in the body and the~     effect of increasing periodic intravenous doses are also studied. Foscarnet is active in~     vitro (test tube) against herpes viruses, including CMV, by inhibiting the virus DNA~     polymerases, enzymes necessary for virus replication, without affecting cellular DNA~     polymerases. Opportunistic CMV disease in AIDS is usually seen as retinitis, colitis,~     esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia. Ganciclovir has been used~     to treat AIDS patients with CMV disease but can cause severe neutropenia (very low neutrophil~     cell counts). Foscarnet does not suppress the production of neutrophils or other leukocytes~     (myelosuppression) and has shown in vitro activity against HIV.~   "
272764|NCT00000725|"~     To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's~     sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon~     alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics~     of both AZT and IFN-A or IFN-A2A when given in combination; to define the maximum tolerated~     dose of each drug in combination and to define doses to be used in Phase II trials. AZT has~     been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and~     both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's~     sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response~     may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in~     combination with IFN-A or IFN-A2A is warranted.~   "
272765|NCT00000724|"~     To study the safety and effectiveness of trimetrexate (TMTX) plus leucovorin calcium rescue~     (LCV) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS,~     patients who are HIV positive, or those for whom laboratory confirmation of HIV infection has~     not yet been established if they are at high risk for HIV infection, and who have not~     responded to standard treatments or who have demonstrated severe or life-threatening~     intolerance to both conventional therapies for PCP.~      The drugs trimethoprim / sulfamethoxazole (TMP / SMX) and pentamidine, usually used to treat~     PCP in AIDS patients, have proven ineffective in many patients and have had to be~     discontinued in many other patients because of severe side effects. TMTX was chosen for this~     trial because it was found to be very active against the PCP organism in laboratory tests~     and, in a preliminary trial in combination with LCV, there was a high response rate without~     severe toxicity.~   "
272766|NCT00000723|"~     To determine the safety and toxicity of high-dose systemic methotrexate (MTX) and~     dexamethasone (DEX) combined with zidovudine (AZT) and brain irradiation in patients with~     AIDS-related primary central nervous system (CNS) lymphoma and to determine response rates~     and survival of treated patients. Also to determine if the treatment inhibits HIV replication~     in patients who are HIV culture and/or antigen positive and to assess the incidence of~     opportunistic infection in these patients Results of radiation given to patients with~     AIDS-related high-grade CNS lymphoma have been disappointing, with short survival times due~     to infection complications. However, complete response has been documented after radiation in~     some patients. High-dose MTX will be used to improve the possibility of a greater~     antineoplastic response than that obtained by radiation alone. Since the underlying~     immunodeficiency state is not affected by therapy directed against the lymphoma, patients are~     still prone to life-threatening opportunistic infections or relapse of lymphomatous disease~     within the CNS. Accordingly, AZT will also be used in an attempt to alter the overall natural~     history of the disease.~   "
272767|NCT00000722|"~     To compare the use of pentamidine aerosol (inhaled mist) with the standard intravenous method~     of administration in patients with AIDS related Pneumocystis carinii pneumonia (PCP), to~     measure the amount of pentamidine aerosol that actually reaches the lung, and to see if close~     clinical observation is safer and as effective as drug therapy in the prevention of PCP~     recurrences. To compare the efficiency of 2 nebulizers - the Respirgard II nebulizer and the~     Cadema Aerotech II nebulizer. Aerosolized pentamidine was as effective as intravenous~     pentamidine in treating PCP in animals. More of the pentamidine reached the lungs and less~     was found in the liver and kidney after pentamidine was given by aerosol than after an~     intravenous injection. This suggests that the toxicity of pentamidine may be less if given by~     aerosol than if given by the intravenous route.~   "
272768|NCT00000721|"~     To determine the maximal safe daily dose of BG8962 (rCD4) which can be administered by~     continuous subcutaneous infusion (CSCI) over 24 hours; to determine the pharmacokinetics of~     BG8962 when it is administered by intramuscular and subcutaneous routes; and to look for dose~     related antiviral activity determined by quantitation of infectious HIV peripheral blood~     leukocytes (PBLs) and plasma, and by monitoring the blood levels of viral p24 antigen (when~     present), CD4+ T-cells, and Beta-2- microglobulin. Recombinant soluble CD4 protein (rCD4) is~     a drug that has been produced by genetic engineering techniques. In laboratory studies, rCD4~     binds to HIV and reduces its ability to enter the cell, thus inhibiting its reproduction.~     Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients, it is~     necessary to determine the maximum dose that can be tolerated by humans. AMENDED: To date,~     Biogen's original sequence recombinant soluble CD4 and Biogen's natural sequence recombinant~     soluble CD4 have both been referred to as recombinant soluble CD4 (rsCD4). In order to~     distinguish between these two products, a change in nomenclature has been made. In this~     protocol, whenever the original sequence CD4 molecule is referred to, it is called~     recombinant soluble T4 (rsT4). Whenever the natural sequence molecule (currently under study~     in this protocol) is referred to, it is called BG8962 or rCD4. Whenever the drug is discussed~     generically, it is referred to as rsCD4.~   "
272769|NCT00000720|"~     To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus~     intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by~     1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection~     in children is most often associated with symptomatic disease and poor prognosis. Treatment~     with antiviral therapy may be effective in changing the course of disease and decreasing~     mortality in this vulnerable population. AZT treatment has been shown to decrease mortality~     and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it~     is likely that children may also benefit from this antiviral therapy. In addition, bacterial~     infections are frequently found in HIV-infected children. Because pooled human serum~     immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in~     patients with defects of immunity, it may reduce the rate of bacterial infection in~     HIV-infected children as well. In this study, AZT will be administered together with IVIG to~     determine safety, tolerance, and efficacy of the combined treatment.~   "
272770|NCT00000719|"~     To determine the long-term safety and tolerance of four alternating and two intermittent~     regimens of zidovudine ( AZT ) and 2',3'-dideoxycytidine ( zalcitabine; ddC ) in the~     treatment of patients with advanced HIV disease who have had to discontinue AZT because of~     true hematologic intolerance to standard reduced doses of AZT.~      AIDS is a serious infectious disease caused by a new family of retrovirus which is spread~     primarily through sexual contact and administration of blood or blood products. Individuals~     who are infected with HIV could therefore benefit from therapy with an effective anti-AIDS~     virus agent. AZT and ddC have both been tested as antiviral agents and their potentially~     beneficial effects may be limited by time- and dose-dependent toxicity. A combination regimen~     using shorter courses of AZT and ddC might therefore be able to sustain treatment without~     producing toxicity. In addition, since the two drugs exhibit their major toxicity on~     different organ systems, cumulative or additive toxicity would not be expected.~   "
272953|NCT00018564|"~     This clinical research program is designed to evaluate medications as new treatments for~     essential tremor. Essential tremor is a common condition with few available therapies.~   "
273147|NCT00013143|"~     Adverse drug events (ADE) present a unique focus for error reduction. Computerized provider~     order entry, with embedded clinical decision support, has great promise in reducing~     medication errors but preventable adverse drug events may still occur despite such systems.~   "
272772|NCT00000717|"~     To determine the safety and effectiveness of clindamycin and primaquine in the treatment of~     mild Pneumocystis carinii pneumonia (PCP) in AIDS patients.~      As many as 80 percent of AIDS patients experience at least one episode of PCP and about~     one-third of these patients have a recurrence of the disease. Drugs currently used for~     treatment of acute PCP are toxic to the majority of AIDS patients. The combination of~     clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in~     animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been~     used safely in humans for treatment of other diseases. It is possible that the combination~     may prove to be as good or better than standard therapy for PCP and side effects may be less.~   "
272773|NCT00000716|"~     To evaluate the safety and tolerance of oral zidovudine (AZT) when given over a period of 24~     weeks to children between 3 months and 12 years of age. The effectiveness of AZT in treating~     HIV infection in infants and children will also be evaluated.~      HIV infection in children is most often associated with symptomatic disease and poor~     prognosis. Treatment with antiviral therapy may be effective in altering the course of the~     disease and decreasing mortality in these children. AZT has been shown to be effective in~     certain adult patients with symptomatic HIV infection. It is therefore likely that infected~     children may also benefit from this treatment.~   "
272774|NCT00000715|"~     To compare the safety and effectiveness of drug therapy with aerosolized pentamidine (PEN)~     with that of conventional therapy, sulfamethoxazole plus trimethoprim (SMX/TMP) in the~     treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV~     positive, or are at high risk for HIV infection.~      New treatments are needed for PCP, a common lung infection in patients with AIDS, because~     many patients treated with the two standard treatments, PEN given by injections and SMX/TMP,~     have had adverse effects that required a change in treatment. There is also a high relapse~     rate after the standard treatments. Preliminary experiments in humans suggest that~     aerosolized PEN is as effective as the standard treatments for PCP, and causes few adverse~     effects.~   "
272775|NCT00000714|"~     To determine the safety and effectiveness of an investigational drug therapy (trimetrexate~     plus leucovorin calcium (TMTX / LCV)) in the treatment of Pneumocystis carinii pneumonia~     (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection, and~     who have suffered severe or life-threatening ill effects from both conventional therapies for~     PCP. AMENDED: 08/01/90 As of August 31, 1989, 437 patients were enrolled into uncontrolled~     studies of trimetrexate for PCP:214 in TX 301/ACTG 0=039 (trimetrexate for patients~     intolerant of approved therapies) and 223 in NS 401 (trimetrexate for patients refractory to~     approved therapies). The analysis of overall response rate, stringently defined as having~     received at least 14 days of trimetrexate and being alive at follow-up 1 month after the~     completion of therapy, reveals 84/159 intolerant patients and 48/160 refractory patients had~     responded, for rates of 53 percent and 30 percent, respectively. These response rates include~     all individuals who received at least one dose of trimetrexate. Of the 111 patients who were~     ventilator-dependent at study entry, 18 completed a course of therapy and were alive a month~     later, for a response rate of 16 percent. All other ventilated patients died. The most common~     severe (grades 3 and 4) toxicities were: transaminase elevation (> 5 x normal) in 94~     patients, anemia (< 7.9 g/dl) in 109, neutropenia (< 750 cells/mm3) in 58, fever (> 40 C) in~     37, and thrombocytopenia (< 50000 platelets/mm3) in 27. Toxicity required discontinuation of~     therapy in approximately 5 percent of all patients.~      Original design: The drugs usually used to treat PCP in AIDS patients, trimethoprim /~     sulfamethoxazole and pentamidine, have had to be discontinued in many patients because of~     severe side effects. Currently there are no proven alternatives to these drugs. TMTX was~     chosen for this trial because it was found to be very active against the PCP organism in~     laboratory tests. Also TMTX, in combination with LCV, had a high response rate and did not~     cause severe toxicity in a preliminary trial.~   "
272776|NCT00000713|"~     To determine the safety of ampligen at several doses in HIV-infected patients who have not~     yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and~     immunologic effects will be studied.~      Evidence indicates that a long period with no symptoms follows infection with HIV.~     Individuals who are infected with the virus could benefit from therapy with a drug that acts~     to kill the virus or to stimulate the immune system of the individual or both. The immune~     system is the means the human body has for fighting infections. Ampligen is a suitable drug~     for clinical trials against HIV because it has been shown to stimulate the immune system and~     to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable~     clinical side effects.~   "
272777|NCT00000712|"~     Original design: The study's purpose is to compare the effects of zidovudine (AZT) alone to~     the combination of AZT and acyclovir (ACV) to determine if AZT/ACV is associated with a lower~     death rate and fewer AIDS related opportunistic infections compared to AZT alone, and to~     investigate the effect of these treatment plans on cytomegalovirus (CMV) and Epstein-Barr~     virus (EBV) infections. The study evaluates two doses of AZT used alone versus two doses of~     AZT combined with ACV. Per 12/11/92 amendment: Another antiretroviral agent may be~     substituted for AZT.~      AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related~     complex and patients being treated for Pneumocystis carinii pneumonia. Drugs that increase~     the effectiveness of AZT against HIV may also decrease the need for high doses of AZT. This~     might reduce some of the negative effects of AZT while not reducing the positive effects.~   "
272778|NCT00000711|"~     To administer colony-stimulating factor (GM-CSF) for 4 weeks to AIDS and advanced AIDS~     related complex (ARC) patients who have been receiving zidovudine (AZT) therapy, in order to~     obtain data on short-term effectiveness, safety, toxicity, pharmacokinetics, and tolerance of~     combined treatment with the two drugs.~      Persons infected with HIV virus may undergo a long latency or persistent virus blood levels~     which may be present before any symptomatic illness. These individuals could, therefore,~     benefit from therapy with an effective antiretroviral agent. AZT, which is a powerful~     inhibitor of human retrovirus, has been approved for management of patients with symptomatic~     HIV infection. GM-CSF not only stimulates the bone marrow, it enhances the function of mature~     blood cells and has been found to enhance the ability of AZT to suppress HIV replication in~     vitro (test tube). Combination therapy with GM-CSF and AZT may lower complications as well as~     the morbidity and mortality associated with HIV infection.~   "
272779|NCT00000710|"~     To determine the safety, pharmacokinetics (blood levels), and effectiveness of didanosine~     (ddI) when administered both intravenously and orally. After the maximum tolerated dose (MTD)~     is determined, an appropriate dosage regimen will then be established for Phase II and Phase~     III trials.~      Zidovudine (AZT) has produced the best clinical results in the drug therapy of AIDS to date,~     but it produces toxicity in approximately 50 percent of patients. Early data show that ddI~     possesses high antiviral activity and less toxicity than AZT. The most effective route and~     dose of ddI has yet to be determined.~   "
272966|NCT00018395|"~     The purpose of this cohort study is to estimate the risk of cardiovascular mortality~     associated with abnormal calcium metabolism~   "
272780|NCT00000709|"~     To provide accurate and complete neurologic assessment of the course of the AIDS dementia~     complex in patients treated with zidovudine (AZT). The study will determine how frequently~     patients improve, how long improvement is sustained, and the magnitude and functional~     significance of improvement.~      Individuals with AIDS frequently suffer central nervous system (CNS) problems that are~     characterized by cognitive, motor, and behavioral deficits, in a disorder known as AIDS~     dementia complex. Clinical experience suggests that its course is often progressive, going~     from initial symptoms to moderate or severe dementia within several months. Accumulating~     evidence now suggests that direct brain infection by the HIV virus is the likely cause of the~     AIDS dementia complex. Case reports suggest that therapy with AZT, which has been shown to be~     a strong inhibitor of HIV replication in vitro, may alleviate the AIDS dementia complex. This~     study will help define the natural history of the AIDS dementia complex in treated patients.~   "
272781|NCT00000708|"~     To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone~     or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis in~     patients who have not been treated previously or who have relapsed after a previous~     successful treatment.~      Cryptococcal meningitis is an important cause of disease and death among patients with AIDS.~     Usually AMB is given either alone or with FLC to patients with this infection, but these~     treatments are not always effective and both have toxic effects. Animal studies and~     preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest~     that it may be less toxic than either AMB or FLC.~   "
272782|NCT00000707|"~     To confirm the ability of pulmonary (lung) function testing (PFT) to detect Pneumocystis~     carinii pneumonia (PCP) before the development of clinical symptoms and to determine if~     pentamidine (PEN), a drug used in treating PCP, can be given effectively as an aerosol~     (inhaled mist). Other goals include the measurement of the actual amount of PEN that reaches~     the lung, and to determine if close clinical observation is safer and as effective as drug~     therapy for the prevention of subsequent episodes of PCP.~      Many AIDS patients develop PCP, but the effectiveness of early diagnosis and treatment of PCP~     is not known. The effectiveness of PEN may be improved if treatment is begun when the~     parasite burden (the number of organisms in the lung) is still small, and before respiratory~     symptoms appear. If PFT of HIV-infected patients is able to identify patients in the early~     stages of infection, outpatient treatment of these patients offers a possible alternative to~     the expense and toxicity of continuous preventive therapy of all high-risk patients.~   "
272783|NCT00000706|"~     Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and~     eliminated through the kidneys in HIV infected patients. Part II studies the effect of~     probenecid and quinine on the same aspects.~      Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep~     adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT~     leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT~     needed for treatment.~   "
272784|NCT00000705|"~     The purpose of this study is to see if giving azidothymidine (AZT) to HIV-positive patients~     with hemophilia is safe and if it is effective in lowering HIV levels and boosting the immune~     system.~      HIV infects and inactivates certain blood cells that are part of the body's immune system.~     The damage to the body's immune system can result in unusual infections and/or unusual forms~     of cancer. A large percentage of hemophiliacs are HIV-positive and there is a clear risk for~     the development of AIDS in these patients. AZT may be effective in lowering HIV levels and~     boosting the immune system but its side effects are not understood in these patients.~   "
272785|NCT00000704|"~     To evaluate the long-term safety and effectiveness of the drug 2',3'-dideoxycytidine (~     zalcitabine; ddC ) in treating patients with AIDS or advanced AIDS related complex ( ARC ).~      Recent studies show that a certain group of drugs (dideoxynucleosides) are effective in~     treating patients with HIV infection. ddC is a dideoxynucleoside and test tube studies show~     that it may be valuable in treating AIDS patients. ddC has been shown to be well tolerated in~     certain patients with AIDS.~   "
272786|NCT00000703|"~     To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine~     (AZT) treatment for patients with peripheral lymphoma.~      Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results~     have not been satisfactory. This study will show whether the combination of chemotherapy,~     radiation, and AZT is more effective and less toxic than previously used treatments.~   "
272787|NCT00000702|"~     To test whether zidovudine (AZT) is useful as a treatment for the neurologic syndrome called~     AIDS dementia complex. To determine how long AZT takes to reach cerebral spinal fluid (CSF),~     how long, and at what concentration it is found there.~      HIV infection can result in impairment in the function of the brain and spinal cord, leading~     to disturbances in the ability to think clearly and in strength and coordination. This~     disorder, which has been called the AIDS dementia complex, may be due to a direct effect of~     HIV on the nervous system. It is known that AZT does get into the brain to some extent, where~     it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of~     the AIDS dementia complex.~   "
272788|NCT00000701|"~     The study is designed to test the drug zidovudine (AZT) in children, including study of drug~     levels in various parts of the body fluids, safety of the drug, and its effect on different~     parts of the body.~      The effects of any drug, the way a drug enters the bloodstream, the way it is used by the~     body, and the way the body eliminates the drug may be very different in children compared~     with adults. The largest group of children who have AIDS are those who are less than 2 years~     of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT~     show that it might be useful in the treatment of AIDS. Thus it is important to study the~     effects of the drug in children.~   "
272789|NCT00000700|"~     To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study~     of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower~     dose results in less harmful side effects while still being effective. Previous studies have~     shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies~     at varying doses. There is a need to see if lower doses result in effective therapy with less~     harmful side effects.~   "
272967|NCT00018382|"~     This study examines the use of insulin-sensitizing compounds, as therapeutic agents for~     cognitive impairment in Alzheimer's disease.~   "
272790|NCT00000699|"~     To determine the safety and effectiveness of treatment with ribavirin (RBV) plus isoprinosine~     (INPX) in preventing the development of AIDS in patients infected with the AIDS virus (HIV).~     Also to determine the maximal dose of RBV that can be tolerated by HIV-infected patients when~     RBV is given with INPX. The patients may or may not have generalized lymphadenopathy syndrome~     (LAS). RBV has prevented the development of AIDS in some HIV-infected patients with LAS and~     INPX has stimulated the immune system of patients infected with HIV. The immune system fights~     infections in the human body, and the HIV attacks T cells that are an important part of the~     immune system. Reports from individual cases treated with both RBV and INPX suggest that~     clinical improvements occurred in HIV-infected patients, but there is no reliable information~     on the safety and effectiveness of this drug combination in such patients.~   "
272791|NCT00000698|"~     To determine the safety and effectiveness of intravenous ganciclovir (also known as DHPG) in~     the treatment of sight-threatening cytomegalovirus (CMV) retinitis in patients with AIDS. CMV~     retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs~     in patients whose immune function has been impaired and is the most common cause of blindness~     in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in~     approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients~     treated with GCV had a relapse after treatment was stopped. Thus, it is important to~     determine if GCV can be safely given over a long period of time (maintenance therapy) and if~     it is effective in preventing a relapse of CMV retinitis.~   "
272792|NCT00000697|"~     To study the safety and effectiveness of foscarnet in the treatment of AIDS patients who have~     active infection with cytomegalovirus (CMV) that is causing inflammation of the retina~     (retinitis). In addition, these patients cannot be treated with ganciclovir (DHPG) because of~     its toxic effect on the body's blood-forming cells or because white blood cell or platelet~     counts were too low.~      CMV is a common virus, which can cause blindness and death in AIDS patients. Previous studies~     demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV~     infection. Although treatment with ganciclovir (DHPG) is also effective, a significant~     toxicity leading to dose-limiting neutropenia (low white blood cell count) in one third of~     treated patients has been associated with the drug. Based on the serious nature of CMV~     retinitis and the lack of alternative drug therapies for DHPG-sensitive patients, the present~     study will evaluate the safety and efficacy of intravenous (IV) foscarnet in AIDS patients~     with CMV retinitis.~   "
272793|NCT00000696|"~     To evaluate the anti-HIV effect of single agent versus combination therapy with zidovudine~     (AZT) and interferon alfa-2a (IFN-A2a), as measured by p24 protein expression, viral growth~     and infectivity in patients with symptomatic HIV disease. To assess the safety of low dose~     schedules of AZT and IFN-A2a, alone and in combination, as measured by neutrophil counts and~     hepatic transaminase levels. To evaluate the comparative effects of single agent versus~     combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity.~      AZT is known to be an effective treatment for HIV infection. However, patients may develop~     reactions to AZT when it is administered for long periods of time. Combining AZT with another~     drug at lower doses might reduce toxicity in patients and prevent the development of drug~     resistant strains. IFN-A2a can reduce the growth of HIV in test tube experiments and recent~     studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV~     more effectively than when either drug is used alone. This study will examine the~     effectiveness and safety of these drugs when they are given together and compare these~     results with the effectiveness and safety of the drugs when they are used alone.~   "
272794|NCT00000695|"~     To determine the highest tolerated dose of the safety and tolerance of interferon beta~     (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS~     related Kaposi's sarcoma. In addition, the studies will determine preliminary data on~     response, immune function, and subcutaneous absorption.~      IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the~     test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV~     reverse transcriptase; Phase I and II study benefits of AZT treatment include increased~     objective clinical improvement, decreased mortality rate, and decreased incidence of~     opportunistic infections. Long-term AZT use, however, presents possible limitations secondary~     to intolerance. This study, therefore, will investigate the potential antiviral activities of~     a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in~     patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy~     consisting of low doses of each drug will reduce the potential of toxicity, treatment~     failures, and disease recurrences resulting from drug-resistant virus mutants.~   "
272795|NCT00000694|"~     To define the best doses of sargramostim ( granulocyte-macrophage colony-stimulating factor;~     GM-CSF ), interferon alfa-2b ( IFN-A2b ), and zidovudine ( AZT ) to give together in patients~     with AIDS-associated Kaposi's sarcoma ( KS ), to learn about the side effects of these drugs~     when they are given together for 8 weeks, and to find out whether the combination of GM-CSF,~     IFN-A2b, and AZT has any effect on KS, HIV, or the immune system.~      Studies show that IFN-A2b can cause KS tumors to shrink or disappear in about 30 percent of~     patients. IFN-A2b can greatly reduce the growth of the HIV virus in test tube experiments and~     perhaps in patients. AZT has also been shown to reduce the growth of HIV and show~     improvements in the immune system with fewer infections. Test tube experiments show that when~     IFN-A2b and AZT are used together, they reduce the growth of the HIV virus much more~     effectively than when either drug is used alone. In recent studies of the combination of~     interferon alpha and AZT in patients with KS, more than 40 percent of the patients showed~     shrinkage of their tumors, and some showed evidence for suppression of HIV growth in the~     body. However, the combination of IFN-A2b with AZT often caused a marked lowering of the~     white blood cell (WBC) count, especially a type of WBC called the granulocyte (or neutrophil)~     which is important in the body's defense against infection. Recombinant human GM-CSF is a~     human protein which is produced in bacteria. It has been shown to cause an increase in the~     WBC count.~   "
272968|NCT00018369|"~     Studies investigating physiological processes involved in aging-related deficits in~     regulation of stress hormone systems.~   "
272969|NCT00018356|"~     This study's primary objective is to determine the independent and combined effects of~     progressive resistance muscle strength training and testosterone on the development of~     sustainable improvements in physical function.~   "
272796|NCT00000693|"~     To study the use of acyclovir (ACV) and zidovudine (AZT) in the treatment of cytomegalovirus~     (CMV) retinitis in patients with AIDS who would otherwise be treated with ganciclovir (DHPG)~     alone.~      CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG~     is at present the only drug available for widespread compassionate use in the United States.~     Although most patients respond to treatment with DHPG, the medication does not cure the~     infection. Most patients will have a relapse and will require retreatment with DHPG. Because~     of the large relapse rate, most people treated for CMV retinitis are placed on continuous~     treatment with DHPG. There are two major problems associated with ongoing use of DHPG: 1) The~     development of a low white blood cell (WBC) count (leukopenia) which is a known side effect~     of the drug; and 2) the increased risk for leukopenia when DHPG is given together with AZT,~     the only antiviral drug currently available for the treatment of HIV infection. Therefore,~     patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is~     made much more severe when the drugs are given together. This has resulted in the difficult~     decision as to whether to forgo potential life-extending therapy with AZT in order to~     preserve sight. An effective treatment for CMV retinitis is needed that will allow the~     patient to also take AZT. ACV is presently the drug of choice for severe herpes virus~     infections. It has been shown to be effective in suppressing severe CMV disease in patients~     who have received bone marrow transplants.~   "
272797|NCT00000692|"~     To determine the following about the use of SC-48334 in patients with AIDS and advanced AIDS~     related complex (ARC):~      1. The largest maximum tolerated dose (MTD); 2. Effectiveness against HIV; 3.~     Pharmacokinetics - how fast SC-48334 reaches the bloodstream, what concentration is reached,~     and how long it remains in the patient's blood.~      SC-48334 is a chemical that prevents the biochemical actions of certain enzymes in the body,~     and recent studies have shown that it may also prevent the activity of HIV. The study will~     attempt to show whether SC-48334 can safely and effectively break the cycle of HIV infection~     in AIDS and advanced ARC by progressively eliminating HIV.~   "
272798|NCT00000691|"~     To examine the usefulness and safety of the antiviral drug foscarnet in treating AIDS~     patients with cytomegalovirus (CMV) infection that is causing sight-threatening inflammation~     of the retina in one or both eyes (CMV retinitis). Because of the seriousness of~     sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for~     those patients who cannot be treated with ganciclovir (DHPG) (because of its toxic effect on~     the body's blood-forming cells, because it did not control the disease, or because patient's~     blood cell or platelet counts are too low to begin with), it is worthwhile to try an~     immediate trial with foscarnet. AMENDED: ACTG 093 was originally designed as a randomized~     dose-ranging study of foscarnet maintenance therapy. Patients enrolled between March 17,~     1989, and January 1, 1990, received either 60 mg/kg/day or 90/mg/kg day as maintenance~     therapy following the 2 week induction period. Based on the preliminary results of ACTG~     015/915, which studied maintenance doses of foscarnet of 60 mg/kg/day, 90 mg/kg/day and 120~     mg/kg/day, the 60-mg/kg/day and 90/mg/kg/day arms of this study have been closed. All~     patients entering the study beginning January 2, 1990 will receive foscarnet maintenance~     therapy on a 120/mg/kg/day algorithm following induction.~   "
272799|NCT00000690|"~     To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when~     taken by mouth. To evaluate its effect on blood coagulation.~      DS has been reported to have anti-HIV activity. However, it is not known how much of the drug~     is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.~   "
272800|NCT00000689|"~     To determine the toxicity and effectiveness of adding sargramostim (recombinant~     granulocyte-macrophage colony stimulating factor; GM-CSF) to a standard chemotherapy drug~     combination (methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and~     dexamethasone) known as mBACOD in the treatment of non-Hodgkin's lymphoma in patients who are~     infected with HIV.~      Treatment of patients with AIDS-associated lymphoma is achieving inferior results when~     compared with outcomes for non-AIDS patients. Treatment with mBACOD has been promising, but~     the toxicity is very high. Patients treated with mBACOD have very low white blood cell~     counts. GM-CSF has increased the number of white blood cells in animal studies and~     preliminary human studies. It is hoped that including GM-CSF among the drugs given to~     lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD.~   "
272801|NCT00000688|"~     To provide information about the usefulness and safety of giving injections of ganciclovir~     (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis.~      CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2~     out of every 10 patients with AIDS. Results from an earlier study suggest that about 80~     percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.~   "
272802|NCT00000687|"~     To determine the safety and effectiveness of combining zidovudine (AZT) and interferon~     alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is~     hoped with the present study to define the rate at which the treatment affects the tumors and~     also to assess any toxic effects of the combination treatment over a period of time.~      In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with~     AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In~     addition, it appeared that there was a substantial reduction in KS lesions with this therapy.~     Potential benefits of this combined therapy include resolution of KS lesions, prolonged~     survival, a decrease in the frequency and severity of opportunistic infections, improvement~     in CD4 cells, and a decrease in serum p24 antigens.~   "
272820|NCT00000669|"~     To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxyinosine (ddI), given~     orally and intravenously, in infants and children with AIDS. The study also measures~     bloodstream and cerebrospinal fluid (CSF) levels of the administered drug, and provides a~     preliminary assessment of the effectiveness of ddI on HIV replication.~      AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term~     dosing data in adults, the dosing period will be extended to 104 weeks. Original design:~     Information presently available indicates that ddI has high antiviral activity with less~     apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).~   "
272970|NCT00018343|"~     This study is designed to evaluate the potential beneficial effects of estrogen on cognitive~     function of women with Alzheimer's Disease.~   "
272803|NCT00000686|"~     To determine the safety and maximum tolerated dose (MTD) of~     2',3'-dideoxy-2',3'-didehydrothymidine (d4T) administered to patients with AIDS or AIDS~     related complex (ARC) who are intolerant of zidovudine (AZT). The study also begins an~     assessment of the effectiveness of d4T therapy on HIV replication, on plasma levels of p24~     antigen, and clinical or immunologic parameters associated with AIDS.~      Of the methods that are being evaluated to treat HIV-infected individuals, AZT has produced~     the best results to date. Toxic effects in approximately 50 percent of patients receiving AZT~     may limit its usefulness for prolonged treatment. Long-term treatment may be necessary to~     prevent progression of early stage HIV infection to AIDS and to prevent secondary~     transmission. Other drugs that may be equally or more effective than AZT and useful in the~     long- term treatment of HIV infection must be developed and evaluated. Test-tube and animal~     studies of d4T show that the drug can inhibit replication (reproduction) of HIV at~     concentrations similar to concentrations of AZT that have anti-HIV activity. These studies~     also indicate that the drug may stay in the bloodstream longer than AZT. Thus, it may be~     possible for the drug to be as effective as AZT when taken less frequently than AZT. It also~     may have a less disturbing effect on other body functions (such as thymidine metabolism).~   "
272804|NCT00000685|"~     To determine how zidovudine (AZT) for the treatment of HIV infection is metabolized and~     excreted or eliminated in patients with infected or diseased kidneys. To determine the~     influence of hemodialysis and establish dose guidelines.~      AZT is the only antiviral agent with demonstrated effectiveness in patients with severe HIV~     infection. Persons with HIV infection may have additional health problems, one of which is a~     diseased kidney due to infection of the kidney, or side effects of therapy. The benefits and~     risks of AZT in patients with diseased kidneys are unknown. It is hoped that this study will~     allow further understanding of the metabolism and excretion of AZT in patients with kidney~     disease. AZT pharmacokinetics will be studied in patients with mild, moderate, and severe~     renal disorders~   "
272805|NCT00000684|"~     To determine the safety and effectiveness of dextran sulfate when it is administered~     intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS~     patients. The effect of dextran sulfate on platelet survival will also be assessed in 3~     patients to help determine the mechanism of thrombocytopenia (low platelets) noted in all~     patients receiving intravenous dextran sulfate in this study.~      Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted~     in humans to determine its effect on HIV when dextran sulfate is given orally have not been~     conclusive. It is hoped that this study will show that dextran sulfate administered~     intravenously~   "
272806|NCT00000683|"~     Evaluation of the safety and immunogenicity (immunological reactivity) of HIVAC-1e vaccine.~     An additional goal is to determine which dose level of vaccine might be most effective.~     Specific questions to be addressed in this part of the study include: Are there adverse~     reactions to gp160 vaccine when given to vaccinees previously immunized with a~     vaccinia-recombinant? Does gp160 vaccination of prior HIVAC-1e vaccine result in stimulation~     of neutralizing antibody and other humoral immune responses? Does vaccination with gp160~     enhance the development of cell-mediated immune responses in HIVAC-1e vaccinees? Is the~     magnitude of immune response to gp160 booster immunization greater following priming with~     GP160 recombinant vaccinia (HIVAC-1e) vaccination than priming with three doses of purified~     recombinant gp160? AMENDED: An 80 mcg dose of gp160 has been chosen for the booster because~     this dose has been shown to be safe and immunogenic in previous trials and allows comparison~     of the late boost in this protocol with the late boost in the protocol in which patients were~     primed with three doses of gp160. Original design: HIVAC-1e vaccine is a preparation of the~     envelope protein of HIV (the virus that causes AIDS). The protein is produced by genetic~     modification in vaccinia virus. The purpose of a vaccine is to produce an artificially~     increased immunity to a particular disease, in this case, AIDS. Since there is no known cure~     for AIDS, the control of this disease necessitates the development of effective prevention~     such as vaccines.~   "
272807|NCT00000682|"~     To evaluate the efficacy of AZT versus ddC in terms of survival, antiviral effects,~     neurological status, and health status in patients post Pneumocystis carinii pneumonia (PCP)~     who received long-term AZT therapy in ACTG protocol 002 While treatment with AZT has been~     found to be effective in prolonging survival and reducing the numbers of opportunistic~     infections in patients with AIDS, during the second year of administration of AZT an~     acceleration in mortality has been observed. The reasons for this are not known at this time.~     The study of what may be an AZT-resistant strain of HIV may benefit patients who have been~     and are still receiving AZT or another drug used in treating HIV ddC. It is hoped that the~     comparison of the effectiveness of AZT and ddC will benefit in the treatment of these~     patients.~   "
272808|NCT00000681|"~     To determine the safety as well as the most effective dose of sargramostim (GM-CSF;~     granulocyte-macrophage colony stimulating factor) that will prevent the side effects caused~     by the combined use of zidovudine (AZT) and various doses of cancer-fighting drugs~     (doxorubicin, bleomycin, and vincristine) in AIDS patients with Kaposi's sarcoma (KS).~      Patients included in this study have KS, which is a type of cancer that occurs in nearly 20~     percent of patients with AIDS. AIDS patients with extensive KS require treatment with~     effective cytotoxic (anti-cancer) agents to reduce the tumor size and with antiretroviral~     agents such as AZT to prevent or ameliorate the development of opportunistic infections. Due~     to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow~     where new blood cells are generated, the combination of these agents is expected to result in~     complications such as granulocytopenia (very low granulocyte counts). Hematopoietic growth~     factors such as GM-CSF may reduce the severity and duration of marrow suppression. This may~     improve survival. Clinical trials of GM-CSF in HIV infected individuals with or without~     granulocytopenia have shown that the progenitor cells (early blood cells) are responsive to~     GM-CSF.~   "
272855|NCT00000634|"~     To generate initial information on the pharmacokinetics (blood levels) and dose~     proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess~     the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children;~     and to confirm that the single doses that achieve certain plasma levels in adults achieve~     similar levels in HIV-infected children.~      Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction)~     of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus~     that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious~     adverse effects.~   "
272809|NCT00000680|"~     1) To determine whether it is possible to remove and culture (increase in number and~     activate) in the laboratory, CD8(+) lymphocytes (white blood cells) from HIV-infected~     patients receiving zidovudine (AZT); 2) To determine the toxicity of returning to the~     patients intravenously the expanded and activated autologous cells (given to the patient from~     whom they were taken), with and without giving the patients recombinant interleukin-2 (~     aldesleukin; IL-2 ) at the same time; 3) To radiolabel (mark) the CD8(+) lymphocytes with~     Indium 111, and then scan the patients to determine the distribution of the CD8(+)~     lymphocytes in those who are and are not given IL-2 infusions; 4) To determine the toxicity~     of IL-2 given at the same time with autologous CD8(+) lymphocytes; 5) To measure changes in~     the immunology of the subjects following these treatments.~      CD8(+) cells are suppressor/killer lymphocyte cells that act to limit replication of viruses.~     It is hoped that the reinfusion of activated autologous CD8(+) cells into patients with AIDS~     will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis (two~     of the leading causes of sickness and death in AIDS patients). This treatment may also stop~     the HIV virus from replicating (reproducing itself) in the AIDS patient. Further activation~     of these cells, once infused, may be necessary. It is hoped that IL-2 will stimulate the~     patient's immune system against the AIDS virus along with the activated CD8(+) cells. Thus,~     IL-2 will be given, and its effects studied.~   "
272810|NCT00000679|"~     To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT)~     in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a~     different safety profile than AZT.~      In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and~     because of the low incidence of mild, reversible neurotoxicity and absence of blood-related~     toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in~     patients with AIDS or advanced ARC is now warranted.~   "
272811|NCT00000678|"~     To compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine (~     AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients who have~     already received at least 1 year of AZT therapy and to define the safety profile.~      ddC has been shown to have an antiviral effect, and AZT is known to significantly decrease~     mortality and to reduce the frequency of opportunistic infections in patients with AIDS or~     advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients~     progress with more opportunistic infections and higher mortality rates. This may be due to~     the emergence of AZT resistant virus isolated from some patients who have been on long-term~     AZT therapy. These isolates were still sensitive to ddC. A study of long-term effectiveness~     of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is~     warranted because (1) ddC has antiviral activity, (2) there is no blood toxicity associated~     with taking ddC, and (3) the effectiveness of ddC in test tube studies does not seem to be~     diminished by decreased effectiveness of AZT.~   "
272812|NCT00000677|"~     To assess the safety and effectiveness of SCH 39304 as primary treatment of acute~     cryptococcal meningitis in HIV-infected patients. Safety and effectiveness of maintenance~     therapy following successful treatment of acute disease are also evaluated.~      Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients.~     Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority~     of patients. Maintenance therapy is recommended but must be balanced against the multiple~     toxicities of the drugs used and the problems associated with the weekly administration of~     intravenous therapy. Treatments that are equally or more effective and less toxic than~     traditional methods are needed, especially oral therapy. SCH 39304 is an orally active~     antifungal drug that in animal studies is active against a wide range of systemic fungal~     infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it~     might be of value in the treatment of cryptococcal meningitis.~   "
272813|NCT00000676|"~     To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches~     (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients~     enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and~     serious bacterial infection). Primarily, to compare the rates of invasive infections by C.~     neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal~     infections between two antifungal prophylactic treatments. Secondarily, to assess the effect~     of prophylaxis on the incidence of severe fungal infections, defined as invasive infections~     and esophageal candidiasis and less severe mucocutaneous infection.~      Serious fungal infections are significant complicating and life-threatening occurrences in~     patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such~     patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly,~     esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and~     coccidioidomycosis also cause significant illness and death in AIDS patients. Once~     established, fungal infections in AIDS patients generally require continuous suppressive~     therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has~     a number of characteristics that would make it a logical candidate to examine as a~     prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to~     be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and~     coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis~     appears favorable, and studies of oropharyngeal candidiasis show it to be effective.~   "
272821|NCT00000668|"~     To determine the pharmacokinetics (blood levels) of three dose treatment plans of oral~     ganciclovir during a 28-day dosing period. Other purposes of the study are to determine in a~     population of HIV seropositive persons with cytomegalovirus (CMV) viremia, the safety,~     tolerance, and patient acceptability of oral ganciclovir given for 28 days, to collect~     preliminary laboratory evidence for antiviral activity and effectiveness of three dose~     regimens of oral ganciclovir based on blood and urine cultures of CMV, and to relate~     antiviral activity to dosage and to serum ganciclovir levels.~      CMV retinitis is an important sight-threatening opportunistic infection which affects about~     10 to 15 percent of people with AIDS. A previous study has shown that treatment with~     ganciclovir resulted in a significant delay in time to first retinitis progression compared~     to untreated controls. More studies are warranted to evaluate effects at different doses.~   "
272887|NCT00022893|"~     The purpose of this study is to enable retreatment with Iodine-131 Anti-B1 Antibody therapy~     for patients with non-Hodgkin's lymphoma (NHL) who previously responded (PR, CCR, or CR) for~     at least 3 months to Iodine-131 Anti-B1 Antibody therapy.~   "
272814|NCT00000675|"~     To study the safety and pharmacokinetics (blood levels) of recombinant human CD4~     immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed~     or declined therapy with zidovudine (AZT). An additional goal of the study is to obtain a~     preliminary indication of the antiviral effects of Cd4-IgG in patients with AIDS or ARC.~      Other approaches in addition to existing treatment of HIV infection need to be evaluated. One~     approach may be to block HIV infection by interrupting the assembly of the virus within the~     cell or the budding of virus from the membrane of the infected cell. In addition, blocking~     the attachment of HIV to its cellular receptor may offer another point of attack. HIV binds~     to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus~     (gp120) is capable of high affinity binding to CD4. Any agent that prevents the attachment of~     gp120 to the CD4 receptor should be able to block virus transmission and spread. Recently,~     scientists have succeeded in producing highly purified recombinant soluble human CD4.~     Recombinant CD4 is capable of binding to HIV envelope protein (gp120) and inhibiting HIV~     infectivity in test tube studies. Potential therapeutic benefit in patients with HIV~     infection could be derived from either or both of these biologic effects. In order to extend~     the length of time that rCD4 stays in the body, the compound has been modified by combining~     it with a human immunoglobulin of the IgG1 class (IgG).~   "
272815|NCT00000674|"~     To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine~     and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients~     with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most~     frequent cause of focal central nervous system infection in patients with AIDS. If untreated,~     the encephalitis is fatal. At present, it is standard practice to give a combination of~     pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of~     sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of~     therapy difficult. There is some information that high doses of parenteral (such as by~     injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus~     sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients~     with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however,~     is costly, requires hospitalization, and is inconvenient for the patient. There is some~     indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral~     clindamycin may be effective. Leucovorin calcium is useful in preventing~     pyrimethamine-associated bone marrow toxicity.~   "
272816|NCT00000673|"~     AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic~     therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of~     systemic therapy with CMV retinitis.~      AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3.~     Nonrandomized eyes will not be used for the primary efficacy evaluation.~      ORIGINAL DESIGN: To determine the effectiveness and safety of ganciclovir (DHPG) therapy in~     AIDS patients suffering from active cytomegalovirus (CMV) infection of the retina of the eye~     (retinitis) when the drug is administered directly into the fluid-filled vitreous cavity of~     the eye by injection.~      CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS~     patients, and left untreated can lead to severe visual loss and blindness. While systemic~     administration of DHPG has been shown to be an effective treatment for CMV retinitis, the~     chronic administration required may be complicated by decreased blood cell counts~     (granulocytopenia) which may require discontinuation of treatment. While withholding~     treatment may allow recovery from the granulocytopenia, interruption of therapy may result in~     reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be~     of benefit to severely neutropenic patients with CMV retinitis.~   "
272817|NCT00000672|"~     AMENDED: 8/29/90 Inclusion of asymptomatic patients with CD4 counts less than 200 cells/mm3.~     Standardization of baseline evaluation schedule to allow 14 days prior to study dosing.~     Reduction in frequency and intensity of follow-up evaluations. Standardization of study~     endpoints. Inclusion of toxicity scoring and management for amylase and triglyceride~     elevations. Clarification of concomitant medication use. Original design: To determine the~     effectiveness of didanosine (ddI) in patients with AIDS or advanced AIDS related complex~     (ARC) who have documented hematologic intolerance to zidovudine (AZT) therapy. To determine~     if the efficacy of ddI increases with increasing doses.~      AZT is effective in reducing mortality in patients with AIDS who receive the drug after the~     first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.~     However, AZT therapy has been associated with significant toxicities. In addition, the~     effectiveness of AZT appears to decrease during the second and third years of therapy. For~     these reasons, the development of alternative therapy that would be at least as effective but~     less toxic is of great importance. The drug ddI is an antiviral agent that inhibits~     replication (reproduction) of HIV with less apparent toxicity than AZT. The major~     dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs of~     2 patients initially receiving 12 mg/kg/day and 12 patients receiving daily doses of 25.8 to~     51.2 mg/kg; symptoms began 8 to 27 weeks after initiating ddI treatment. These~     neuropathy-like symptoms have generally not been associated with significant abnormalities in~     nerve conduction studies and patients have reported marked improvement in symptoms within 1~     to 2 weeks of discontinuing ddI. Some patients have resumed ddI treatment at a reduced dose~     after resolution of their symptoms. Studies indicate that ddI remains active in the body for~     at least 12 hours. This indicates that benefits of ddI might be achieved with a low frequency~     of drug administration.~   "
272818|NCT00000671|"~     To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in~     patients with AIDS or advanced AIDS-related complex (ARC) who have tolerated AZT therapy for~     12 months or longer. Per amendment, asymptomatic patients with CD4 counts less than 200~     cells/mm3 are eligible.~      AZT is effective in reducing mortality in patients with AIDS who receive the drug after the~     first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.~     However, AZT therapy has been associated with significant toxicities. In addition, the~     effectiveness of AZT appears to decrease during the second and third years of therapy. For~     these reasons, the development of alternative therapy that would be at least as effective but~     less toxic is of great importance. The drug ddI is an antiviral agent that inhibits~     replication of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains~     active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low~     frequency of drug administration.~   "
272819|NCT00000670|"~     To evaluate the interaction of probenecid with zidovudine (AZT). Because AZT is eliminated~     quickly from the body, it must be taken frequently. A previous study showed that probenecid~     slowed the elimination of AZT without side effects, but that study lasted only 5 days. This~     study is to see whether this effect continues for 1 month and whether the continuation of~     probenecid and AZT is free of side effects over 1 month.~   "
272888|NCT00022880|"~     The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody, to see what~     effects it has on patients with CLL and to determine the highest dose of Iodine-131 Anti-B1~     Antibody that can be given without causing severe side effects.~   "
272822|NCT00000667|"~     To determine the safety of intradermal gp160 in HIV seropositive individuals who are~     asymptomatic and have a relatively intact immune system. To determine whether there is~     evidence of a delayed-type hypersensitivity (DTH) response (a positive skin test) in these~     patients, and also the dose of gp160 that elicits a delayed-type hypersensitivity (DTH)~     response. Early immunity to HIV may play an important role in the long interval between virus~     infection and the onset of clinical disease. Immune responses have been demonstrated in~     HIV-infected individuals within weeks to months of infection. Although none of these~     responses has been shown to be protective, it is possible that boosting anti-HIV immune~     responses through immunization may slow the progression of HIV infection. DTH responses to~     HIV-derived recombinant envelope glycoprotein could provide a means of measuring an important~     immune function in infected patients, and serve as an easily measured surrogate marker of~     cellular immunity. In addition to eliciting local, cutaneous DTH responses, intradermal~     inoculation of skin test antigens may be immunogenic, resulting in new antibody production~     and cellular immune responses. This study allows direct comparison of gp160 administered~     intradermally with alum-adjuvanted intramuscular preparation with respect to immunogenicity~     in HIV seropositive patients.~   "
272823|NCT00000666|"~     To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in~     individuals who are coinfected with HIV and latent Toxoplasma gondii.~      Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard~     treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine.~     Continuous treatment is necessary to prevent recurrence of the disease, but constant use of~     pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be~     effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates~     pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91~     amendment, clindamycin arm was discontinued).~   "
272824|NCT00000665|"~     To evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the~     treatment of cytomegalovirus (CMV) retinitis in people with AIDS; to evaluate the relative~     effect on survival of the use of these two anti-CMV agents in the treatment of CMV retinitis;~     to compare the relative benefits of immediate treatment with foscarnet or ganciclovir versus~     deferral of treatment for CMV retinitis limited to less than 25 percent of zones 2 and 3.~      CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is~     currently the only drug approved for treatment of CMV retinitis in immunocompromised~     patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS~     patients when ganciclovir is discontinued. Because of their similar hematologic (blood)~     toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More~     recently the drug foscarnet has become available for investigational use. Studies so far~     indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that~     relapse occurs in virtually all patients when the drug is discontinued. The relative~     effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV~     infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV~     retinitis, survival, and morbidity are unknown. There is also no definitive information on~     the relative effectiveness and safety of deferred versus immediate treatment for CMV~     retinitis confined to zones 2 and 3.~   "
272825|NCT00000664|"~     To determine the safety of polyethylene glycolated IL-2 (PEG IL2) administered weekly or~     biweekly (per amendment) in a setting of oral zidovudine (AZT). To determine the effect of~     PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV~     virus and antibody titers. To evaluate a chronic dosing study phase offered to patients who~     complete the initial 25-week regimen.~      Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating~     viral replication (reproduction and growth). A main thrust of current treatment is the~     combination of antiviral drugs that may be more effective when combined than when each is~     used alone.~   "
272826|NCT00000663|"~     To determine the safety profile, assess pharmacokinetic properties (blood levels), and obtain~     preliminary indication of the antiviral and immunologic effects of recombinant CD4~     immunoglobulin G (CD4-IgG).~      CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has~     antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC)~     have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or~     subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been~     observed to date.~   "
272827|NCT00000662|"~     To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who~     are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to~     monitor adverse effects of AZT.~      Previous studies with pediatric patients have shown improvements in clinical, immunologic,~     and virologic parameters with administration of AZT.~   "
272828|NCT00000661|"~     To determine if a pharmacokinetic (blood level) interaction exists between zidovudine (AZT)~     and oxazepam in the HIV-infected patient. Benzodiazepines (such as oxazepam) are among the~     most frequently prescribed class of drugs and are commonly used therapeutically for patients~     with chronic disease. This study is important because of the potential for toxicity resulting~     from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the~     combination of these drugs in patients with HIV infection.~   "
272829|NCT00000660|"~     To define the toxicity and maximum-tolerated dose of weekly oral etoposide (VP-16) in~     patients with AIDS-related Kaposi's sarcoma; to determine the clinical pharmacology of orally~     administered VP-16 in AIDS patients. A secondary objective is to obtain preliminary data for~     determining the effect of oral VP-16 on Kaposi's sarcoma.~      VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration~     and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day~     cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy.~     Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid~     the pain, inconvenience, and potential complications associated with medications administered~     intravenously. The relative ease of outpatient administration and the potentially significant~     antitumor activity of oral VP-16 motivates this study. The possibility of weekly drug~     administration is the other focus of this study.~   "
272971|NCT00018330|"~     This study is designed to determine whether sequence variation in the lipoprotein lipase~     (LPQ) gene affects the amount of weight loss and metabolic responses during a hypocaloric~     diet treatment for overweight and obese (BMI=25-35 kg/m2), older (50-65 yrs), sedentary~     veterans.~   "
272830|NCT00000659|"~     Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in~     HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to~     determine the pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT.~     Parts 1B and 2: To test for additive or synergistic activity between rsCD4 and AZT as judged~     by falls in HIV-1 p24 antigen levels; and to evaluate the safety of rsCD4 and AZT in patients~     with AIDS and advanced ARC.~      AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without~     toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow~     function. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT~     have now been found which appear to have reduced sensitivity to AZT. The incidence of~     toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability~     to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4~     (rCD4) has shown antiretroviral effects and has been shown to be safe when given to AIDS and~     ARC patients either as a single agent or in combination with AZT.~   "
272831|NCT00000658|"~     To determine the impact of dose intensity on tumor response and survival in patients with~     HIV-associated non-Hodgkin's lymphoma (NHL).~      HIV-infected patients are at increased risk for developing intermediate and high-grade NHL.~     While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency~     is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been~     disappointing. Treatment is frequently complicated by the occurrence of multiple~     opportunistic infections, as well as the presence of poor bone marrow reserve, making the~     administration of standard doses of chemotherapy difficult. A recent study was completed~     using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin,~     vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate~     was observed in patients treated with this combination of chemotherapeutic agents, with a~     number of durable remissions and reduced toxicity when compared to previous experience with~     more standard treatments. A subsequent study showed similar effectiveness using a lower dose~     of methotrexate administered on day 15. It is hoped that the use of sargramostim~     (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function~     and allow for administration of a higher dose of chemotherapy.~   "
272832|NCT00000657|"~     To compare the safety and effectiveness of orally administered didanosine (ddI) with high~     dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of~     the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses~     of up to 1000 mg/day.~      HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC~     may be caused by some action of the AIDS virus on the nervous system, although similar~     problems can be caused by other infections because the AIDS virus lowers the body's ability~     to fight other infections. It is important to determine whether symptoms are due to ADC or to~     some other infection since treatment varies for different conditions. AZT has been shown to~     be beneficial to people with ADC although its effectiveness has only been studied in a small~     number of patients. Studies suggest that higher doses of AZT are more likely to be effective~     than standard doses in improving symptoms of ADC.~   "
272833|NCT00000656|"~     To assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose~     schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic~     HIV-infected patients. Because of the failure with long-term (more than 1 year) use of,~     frequency of toxicity from, and drug resistance to AZT, drug combinations need to be~     developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the~     development of resistance, while providing at least the same effectiveness.~   "
272834|NCT00000655|"~     To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis~     agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP)~     in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and~     SMX/TMP in AIDS patients with an acute episode of PCP.~      Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine~     isetionate. Although both treatments are equally effective, side effects prevent completion~     of therapy in 11-55 percent of patients.~   "
272835|NCT00000654|"~     To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4~     different dose levels. To determine the peak and trough blood levels of FIAU and its~     metabolites during two weeks of oral dosing with FIAU.~      The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are~     highly and specifically active compounds in vitro against several herpes group viruses,~     particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and~     cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary~     metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is~     anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as~     FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally,~     is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral~     doses are expected to provide concentrations of FIAU exceeding the in vitro minimum~     inhibitory concentration for nearly all the herpes group viruses.~   "
272836|NCT00000653|"~     To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two~     doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with~     symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT )~     (development of toxicity during prolonged AZT therapy), demonstrated disease progression~     after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months~     of AZT therapy.~      As useful as AZT appears to be in the treatment of patients infected with HIV, it is~     associated with significant toxicity in some patients, and it does not prevent ultimate~     progression to AIDS and eventual mortality. Thus, there is a clear need for new~     antiretroviral drugs, and ddC is one such promising agent.~   "
272837|NCT00000652|"~     To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine~     (ddI) in children with HIV infection.~      New approaches to using available agents may provide increased or improved treatment options~     for AIDS. Combination therapy is expected to play a major role in improving survival and~     quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most~     extensively evaluated and for which the evidence for antiretroviral effectiveness is~     strongest.~   "
272838|NCT00000651|"~     To evaluate the safety of zalcitabine (dideoxycytidine; ddC) alone and in combination with~     zidovudine (AZT) versus AZT alone when administered to asymptomatic patients with a CD4 count~     = or < 200 cells/mm3 and symptomatic patients with a CD4 count = or < 300 cells/mm3. To~     compare the effectiveness of ddC alone and in combination with AZT versus AZT alone.~      ddC has been shown to demonstrate an antiviral effect. AZT has been shown to significantly~     decrease mortality and reduce the frequency of opportunistic infections in patients with AIDS~     or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and~     patients progress with more opportunistic infections and higher mortality rates. Because of~     the demonstrated antiviral activity, absence of hematologic toxicity, and lack of cross~     tolerance in laboratory studies of ddC, a study to investigate the long-term effectiveness of~     ddC in patients with HIV infection who have received AZT therapy is warranted.~   "
272839|NCT00000650|"~     To determine, in HIV-infected patients, the magnitude and duration of the biological effects~     of ditiocarb sodium (sodium diethyldithiocarbamate; DTC) that may be relevant to treatment of~     HIV infection.~      DTC has been studied in previous clinical trials in HIV-infected patients with the suggestion~     of delay in disease progression to AIDS and improvement in CD4 counts while on the drug.~   "
272840|NCT00000649|"~     To assess the safety and tolerance of multiple oral doses of nevirapine in combination with~     zidovudine (AZT); to get information on the pharmacokinetics (blood levels) and dose~     proportionality of nevirapine/AZT with multiple dosing; to characterize the pattern of~     virological activity in vivo (in humans) of nevirapine in combination with AZT; to determine~     whether development of resistance to either drug is slowed by the use of the combination.~      Drugs now used in treatment for patients with AIDS show some toxicity which limits their~     usefulness. In addition, with long-term treatment with AZT, there is evidence of virus~     resistance to the drug. Compounds that are more effective and less toxic than those in~     present use would be beneficial, especially if they are active against AZT-resistant viruses.~     Nevirapine has shown in vitro (test tube studies) activity in inhibiting HIV replication~     (reproduction). In vitro studies have shown that nevirapine and AZT work together to inhibit~     HIV replication.~   "
272841|NCT00000648|"~     To provide information on the response of HIV infected, neurosyphilis patients to the~     currently recommended treatment for neurosyphilis; to determine whether possible co-infection~     with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the~     usefulness of an alternative treatment which, if effective, would permit outpatient treatment~     for neurosyphilis that until now required prolonged hospitalization.~      Studies suggest that syphilis treatment failures may be more common in HIV infected patients~     than in patients without HIV infection and that treatment failures occur due to and/or are~     displayed as central nervous system (CNS) involvement. Very little is known about the best~     treatment course for neurosyphilis in patients who are also infected with HIV.~   "
272842|NCT00000647|"~     To restore immunologic function and virus-free state in HIV-infected patients. Based on~     previous studies showing temporary improvement in immune function in HIV-infected patients~     using peripheral lymphocyte transfers and bone marrow transplantation, and based on studies~     documenting the antiretroviral effects of zidovudine (AZT) and interferon-alfa (IFN-A) as~     well as the preliminary test tube and patient studies suggesting anti-HIV effects of~     recombinant CD4-IgG, we propose to treat HIV-infected patients using combination~     antiretroviral therapy with transplantation of bone marrow and peripheral lymphocytes from~     previously immunized donors in an attempt to restore immunologic function and a virus-free~     state.~   "
272843|NCT00000646|"~     To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS~     patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease~     such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of~     zidovudine (AZT) activity.~   "
272844|NCT00000645|"~     To determine the maximum tolerated dose (MTD) of hypericin, to define the types of toxicities~     that may be observed, and to determine what doses of the drug are associated with~     improvements in virological and immunological surrogate markers of HIV infection. To~     determine the bioavailability of synthetic hypericin given in 2 percent benzyl alcohol~     solution.~      Hypericin is unlike other drugs presently being used to treat AIDS patients. Hypericin shows~     anti-HIV activity in test tube experiments.~   "
272845|NCT00000644|"~     This study is designed to evaluate the efficacy and safety of clarithromycin given orally at~     1 of 3 doses to treat disseminated Mycobacterium avium complex infections (MAC) in patients~     with AIDS.~      Mycobacterium avium complex (MAC) is thought to be the most common disseminated bacterial~     opportunistic infection in AIDS, with clinical prevalence estimates ranging from 15 to 50~     percent of all AIDS patients. Clarithromycin, a new macrolide antimicrobial agent, has~     demonstrated activity against MAC both in the laboratory and in animals. Clinical experience~     treating AIDS patients with clarithromycin for disseminated MAC is limited. However, early~     studies have indicated few adverse effects and some improvement in clinical symptoms scores~     and Karnofsky performance scores over placebo treated patients.~   "
272846|NCT00000643|"~     To evaluate the effectiveness of pyrimethamine (given with leucovorin calcium versus placebo~     (an inactive substance) for the primary prophylaxis (prevention) of cerebral toxoplasmosis in~     HIV-infected patients.~      Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in~     the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent.~     Pyrimethamine is a drug that appears promising for the primary prevention of cerebral~     toxoplasmosis in HIV-infected patients.~   "
272854|NCT00000635|"~     To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in~     treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus~     ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV~     infection in patients with AIDS is often associated with skin sores and frequent recurrences.~     Treatment with the drug acyclovir results in healing for most patients, but repeated~     treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens,~     other treatments need to be used. Trifluridine is an antiviral drug that is used for the~     treatment of Herpes infections that occur in the eye. This study attempts to determine if~     trifluridine is useful for treating HSV sores that have not healed after treatment with~     acyclovir.~   "
273660|NCT00005727|"~     To conduct a randomized, controlled trial of cardiovascular disease nutrition education using~     a cluster design with two conditions, special intervention (SI) and usual care (UC).~   "
272847|NCT00000642|"~     Part 1: To determine both the safety, tolerance, and pharmacokinetic profile (blood levels)~     of recombinant CD4 immunoglobulin G (rCD4-IgG) by intravenous bolus administration (given~     through the vein) in women with HIV infection who are in their third trimester (last three~     months of pregnancy). To determine the safety of maternal/fetal transfer of rCD4-IgG in~     infants born to mothers entered into the study. To obtain a preliminary indication of the~     antiviral and immunologic effects of rCD4-IgG in HIV seropositive pregnant women and their~     newborns.~      AMENDED: Part 2: To determine the safety profile of rCD4-IgG in HIV-1-infected women at the~     onset of labor and in their newborns. To determine the extent of placental transfer of~     rCD4-IgG when administered to the mother at onset of labor. To determine the pharmacokinetics~     of rCD4-IgG in newborns. To obtain preliminary evidence of the ability of rCD4-IgG to prevent~     intrapartum transmission of HIV-1 from mother to fetus.~      An agent that can prevent HIV infection is desirable for those at risk of infection as well~     as in the pregnant female and newborn populations. Such an agent may help prevent the~     progression of the disease in infants and children in early stages of infections. In theory,~     rCD4-IgG has antiviral effects.~   "
272848|NCT00000641|"~     To compare the effectiveness and toxicity of two combination drug treatment programs for the~     treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per~     03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with~     either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is~     the most common systemic bacterial infection complicating AIDS in the United States. The~     prognosis of patients with disseminated M. avium is extremely poor, particularly when it~     follows other opportunistic infections or is associated with anemia. Test tube studies and~     clinical data indicate that the best treatment program may include clofazimine, ethambutol, a~     rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin~     is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin.~     Its role in treatment programs is a key issue because of toxicity and because it must be~     administered parenterally (by injection or intravenously).~   "
272849|NCT00000640|"~     To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis~     carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a~     standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance~     of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per~     09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments~     in patients who are intolerant to SMX/TMP.~      The type of treatment being studied has the advantages of wide applicability throughout the~     world (including developing countries) and low cost. An oral treatment is more accessible to~     patients than drugs given by injection or by inhalation.~   "
272850|NCT00000639|"~     To evaluate the effectiveness and safety of amphotericin B plus flucytosine~     (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal~     meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole~     versus itraconazole.~      At least 10 percent of patients with a low CD4 count and HIV infection will develop~     meningitis due to Cryptococcus neoformans. More effective treatments than the standard~     therapy need to be explored.~   "
272851|NCT00000638|"~     To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH)~     versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation~     tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium~     tuberculosis.~      Current guidelines from the American Thoracic Society and the Centers for Disease Control~     recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals.~     Although the effectiveness of this treatment is not known for HIV-infected individuals,~     several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to~     80 percent effectiveness. Problems with this treatment include compliance, adverse reaction,~     and the possibility of not preventing disease due to tuberculosis organisms being resistant~     to INH. A two-month preventive treatment plan should help in increasing compliance. In~     addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug~     resistance. If this study shows equal or greater effectiveness of the two-month rifampin /~     pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both~     HIV-positive and HIV-negative individuals.~   "
272852|NCT00000637|"~     To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI)~     and compared to the combination of AZT and ddI as determined by survival and disease~     progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus~     ddI in symptomatic HIV infected children; to compare the virological and immunological~     parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS~     in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect.~     Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment,~     but later have progression of the disease. Thus, new drug treatments are needed. Studies of~     ddI in adults and children indicate some effectiveness of the drug. A direct comparison of~     AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT~     plus ddI) may give added therapeutic benefit to children.~   "
272853|NCT00000636|"~     To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide~     versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in~     patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb).~      Current guidelines recommend 6 to 12 months of treatment with INH for purified protein~     derivative (PPD)-positive individuals. Problems with this treatment include compliance,~     adverse reaction, and the possibility of not preventing disease due to INH-resistant~     organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more~     effective than longer courses of INH. A two-month prevention course should help to increase~     compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome~     problems with drug resistance.~   "
272889|NCT00022867|"~     Increasing bone mass during puberty can ultimately decrease the risk of developing~     osteoporosis, which causes bones to weaken and break more easily later in life. The purpose~     of this study is to compare calcium absorption and bone growth in boys and girls on diets~     including either a nondigestible oligosaccharide (NDO) or simple sugar.~   "
273661|NCT00005726|"~     To develop and evaluate a nutrition education program to reduce cardiovascular disease risk~     in persons with low literacy skills.~   "
272856|NCT00000633|"~     To determine the safety and immunogenicity of vaccinia-derived HIV-1 recombinant envelope~     glycoprotein (gp160) in asymptomatic HIV-infected adult volunteers. To compare safety and~     immunogenicity of two different schedules of gp160 administration. To examine the effects of~     gp160 and hepatitis B vaccine (Engerix-B) on various markers of viral load and on selected~     immune parameters.~      Potentiation of a patient's immune response to HIV might possibly prolong the period of~     clinical latency and protect the patient indefinitely. Preliminary results from a study of~     Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that~     the vaccine is safe and produces antibodies against the virus. Because another previous study~     failed to demonstrate a specific anti-HIV response in patients injected with a recombinant~     vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role~     of other immunizations (such as hepatitis B vaccination) that would be expected to induce a~     nonspecific immune response in HIV-infected persons.~   "
272857|NCT00000632|"~     To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0,~     30, 180, and 365.~      Preliminary immunologic data from protocol VEU 005B show evidence of the development of~     functional antibodies in the form of increased peptide binding and development of~     neutralizing antibodies. Evaluation of an antigen dose having potentially greater~     immunogenicity is therefore of particular interest.~   "
272858|NCT00000631|"~     Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine~     (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a~     significant advantage in the degree and duration of immunogenicity. Secondary: To learn more~     about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn~     and HIVAC-1e).~      Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have~     persisted in most recipients for 6 months after boosting, and responses seem significantly~     higher and more persistent than responses achieved by just two doses of soluble protein~     vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited~     cohort of volunteers whether additional boosting with soluble recombinant gp160 results in~     increased immunogenicity of longer duration.~   "
272859|NCT00000630|"~     To determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e)~     provides a significant advantage in immunogenicity (production of antibodies) compared to~     priming with a soluble recombinant protein (gp160); to learn more about the safety of the~     combination use of the two HIV envelope vaccines utilized in the study.~      Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines,~     HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include:~     Does combination vaccination result in a synergistic (added) response not predicted by just~     the addition of a second vaccination, and does this synergism depend on the unique priming~     effect of a vaccinia recombinant, or will any combination do?~   "
272860|NCT00000629|"~     Primary objective: To study the pharmacokinetic interaction between zidovudine (AZT) and~     valproic acid in asymptomatic HIV-infected patients, characterizing AZT's oral~     bioavailability, plasma elimination half-time, plasma levels, and urinary excretion of AZT,~     5'-O-glucuronide (GAZT), and 3'-amino-3'-deoxythymidine (AMT). Secondary objective: To~     establish the safety of short-term administration of AZT and valproic acid in combination~     with regard to hematologic parameters and liver function in asymptomatic HIV-infected~     patients.~      Preliminary studies using human liver tissue have shown that valproic acid inhibits the~     metabolic inactivation of zidovudine (AZT), which may prolong the plasma half-life of AZT and~     thus prolong the duration of the drug's effects in the body.~   "
272861|NCT00000628|"~     Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine~     (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with~     L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a~     study of the antiviral activity of L-697,661.~      L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and~     growth) in cell culture. It works together with AZT against HIV.~   "
272862|NCT00000627|"~     To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2)~     maintenance therapy to prevent relapse of histoplasmosis.~      Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a~     triazole antifungal agent that has been used successfully in the treatment of experimental~     histoplasmosis in animals, but has not been completely evaluated in patients for this use. It~     has been approved by the Food and Drug Administration for certain other fungal infections.~     Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a~     pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.~   "
272863|NCT00000626|"~     Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin /~     vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating~     factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe~     the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with~     Hodgkin's disease.~      Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year~     study period; to observe the incidence of bacterial and opportunistic infections in~     HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of~     life of patients receiving this regimen.~      Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by~     chemotherapy, allowing more timely administration of chemotherapy and improved response.~   "
272864|NCT00000625|"~     To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT~     plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected~     patients with CD4 counts of 200-500 cells/mm3.~   "
272865|NCT00023192|"~     This study will compare the health and well being of children treated with a modified stem~     cell transplantation procedure for chronic granulomatous disease (CGD) with that of children~     receiving standard of care treatment. CGD is an inherited disorder of neutrophils-a type of~     infection-fighting white blood cell-that leaves patients vulnerable to life-threatening~     infections. Standard treatment with antibiotics, and sometimes surgery, is not always~     successful, and patients with persisting infections have a poor long-term prognosis.~      Transplantation of donated stem cells (cells produced by the bone marrow that mature into~     white and red blood cells and platelets) can improve immune function in patients with CGD and~     possibly cure the disease. However, this procedure carries a significant risk of death,~     because it requires complete suppression of the immune system with high-dose chemotherapy. In~     addition, lymphocytes-another type of infection-fighting white blood cell-from the donor may~     cause what is called graft versus host disease (GvHD), in which the donor cells 'see'~     patient's cells as foreign and mount an immune response to reject them. To try to reduce~     these risks, patients in this study will be given low-dose chemotherapy that is easier for~     the body to tolerate and involves a shorter period of complete immune suppression. Also, the~     donor's lymphocytes will be removed from the rest of the stem cells to be transplanted,~     reducing the risk of GvHD.~      Patients with CGD between 2 and 17 years of age who 1) are currently free of active~     infection, and 2) have a history of at least one life-threatening infection or a family~     member with CGD and a history of at least one life-threatening infection, and 3) a family~     member that is a suitable donor may be eligible for this study. Candidates will have a~     medical history, physical examination and blood tests, lung and heart function tests, x-rays~     or CT scans of the body, and dental and eye examinations. They will fill out questionnaires~     that measure emotional well being, quality of life, and intelligence (ability to learn and~     understand).~      Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF~     will be injected under the skin for several days to move stem cells from the bone marrow to~     the bloodstream. Then, the stem cells will be collected by apheresis. In this procedure the~     blood is drawn through a needle placed in one arm and pumped into a machine where the~     required cells are separated out and removed. Then, the rest of the blood is returned through~     a needle in the other arm.~      Several days before the transplant procedure, patients will start a 'conditioning regimen' of~     chemotherapy with cyclophosphamide, fludarabine and Campath 1H. When the conditioning therapy~     is completed, the donor's stem cells will be infused. To help prevent rejection of donor~     cells, cyclosporine will be given by mouth or by vein starting 1 month after the transplant~     procedure.~      The average hospital stay for stem cell transplantation is 21 days. After discharge, patients~     will return to the NIH clinic for follow-up clinic visits weekly or twice weekly for 2 to 3~     months. These visits will include a symptom check, physical examination and blood tests.~     Subsequent clinic visits will be scheduled 1 to 3 times a year for at least 5 years.~   "
272866|NCT00023166|"~     Studies of PEG-paclitaxel have been terminated~   "
272890|NCT00022854|"~     Anterior cruciate ligament (ACL) reconstruction is surgery that is done to repair a damaged~     ligament in the knee. In this study we will look at whether the femoral nerve block, a~     commonly used method for pain relief after ACL reconstruction, affects the way patients feel~     after surgery. We will study recovery during the first week after surgery and also 3-12 weeks~     after surgery. We will give all patients spinal anesthesia. Some patients will also receive a~     continuous femoral nerve block for 2 days, or by a single injection. We predict that patients~     who received the nerve block will have significantly improved pain results, compared to~     patients who did not receive the nerve block.~   "
272867|NCT00023153|"~     This study will evaluate the safety and effectiveness of adefovir plus lamivudine for chronic~     hepatitis B infection in people with and without HIV infection. Lamuvidine, an FDA-approved~     treatment for hepatitis B infection, also works against HIV. In some patients, the hepatitis~     B virus (HBV) continues to reproduce despite lamivudine treatment. Adefovir is an~     experimental drug that inhibits HBV replication and may work against some strains of the~     virus that have become resistant to lamivudine.~      Patients 21 years of age or older with active hepatitis B infection despite treatment with~     lamivudine for at least 1 year may be eligible for this 48-week study. Patients both with or~     without HIV infection may participate. Candidates will be screened with a medical history,~     blood and urine tests, liver ultrasound exam, electrocardiogram (EKG) and chest X-ray.~      Participants will have a physical examination, review of their medical history, blood tests,~     and a 24-hour urine collection. They will be admitted to the hospital for a liver biopsy to~     determine if they can receive the study drug. For this procedure, the patient is given a~     sedative for relaxation. The skin over the biopsy is numbed with an anesthetic and the biopsy~     needle is passed rapidly into and out of the liver to collect a tissue specimen. Patients are~     monitored in the hospital overnight for possible complications. After discharge, they return~     home and begin taking the study medications.~      Patients will be randomized to two treatment groups. One group will take 10 milligrams/day of~     adefovir by mouth, and the other will take a placebo-a lookalike pill with no active~     ingredient. Both groups will also take 150 mg lamivudine by mouth and L-carnitine pills or~     liquid. Patients with HIV infection will continue to take antiretroviral therapy as well.~      Patients will be followed in the clinic at study weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36,~     40 and 44 for blood and urine tests to determine the safety of the drug and to evaluate the~     response to treatment. On week 48, a repeat 24-hour urine test and repeat liver biopsy will~     be done. At the end of the 48 weeks, patients may continue to receive adefovir for another 48~     weeks and possibly longer. All those who participate in this extension phase will receive~     active adefovir, regardless of whether they had previously taken adefovir or placebo.~      All patients will have the option to enroll in a separate study to examine the levels of HBV~     (and levels of HIV in HIV-infected patients) in the blood immediately after starting~     treatment and to determine if these initial levels can predict later outcome. This involves~     seven additional visits, for which participants will be compensated. At these visits, blood~     will be drawn on study days 0 (before starting drug treatment), 1, 3, 5, 7, 10 and 21 for HIV~     and HBV viral loads and specialized immunology tests.~   "
272868|NCT00023140|"~     Butadiene is a suspect human carcinogen to which most people are exposed daily. Exposures are~     difficult to measure by air sampling. This study examines the relationship between air levels~     and several biomarkers of exposure. Biomarkers are substances analyzed in human tissues or~     waste products. Adducts are materials formed when a chemical reacts with a biological~     material. In this study we are looking at biomarkers in the blood: hemoglobin and DNA~     adducts, and urinary metabolites. If a strong relationship is found then the amounts of~     biomarkers in a person's blood or urine can tell us how much they have been exposed. The~     tests are being conducted on petrochemical workers who have a wide range of exposures to~     butadiene. An international group of investigators is conducting the study.~   "
272869|NCT00023127|"~     Controlled trial of an intervention to reduce indoor exposures to cockroach allergens among~     asthmatic children in NYC.~   "
272870|NCT00023114|"~     The purpose of this project is to do cross species comparisons of the metabolism and toxicity~     of a number of toxicants which require metabolism for toxicity. All of the toxicants in~     question are encountered by humans in the workplace, through lifestyle choices (cigarette~     smoking) and as a result of environmental contamination. The high incidence of pulmonary~     diseases in the human population means that it will be difficult if not impossible to~     determine whether humans are at risk from exposure to these chemicals without solid~     mechanistic data. Recent rodent bioassays suggest that these compounds have oncogenic~     potential further supporting the need to test the potential for injury in primates. As part~     of this testing, we intend to establish in vitro methods for assessing critical steps in the~     metabolism of these agents and their interaction with cellular macromolecules. Once this is~     done, similar studies can be conducted in Rhesus or in human lung tissue that is available~     because it cannot be used for transplant purposes.~   "
272871|NCT00023101|"~     This prospective cohort study of 400 lead exposed and 400 non-lead exposed women and their~     husbands assesses endocrine dysfunction and adverse reproductive outcomes. Residing in two~     study areas in Shenyang, China, the women are married, 20 and 34 years of age, never smokers,~     have obtained permission to have a child, and have attempted to become pregnant over the~     course of the study. Lead exposure is defined by lead levels in blood samples collected at~     the baseline survey (both women and their husbands), first and second trimesters, and at~     delivery (both maternal and cord blood). Endocrine dysfunction is monitored by urinary~     hormone metabolites including follicle-stimulating hormone (FSH), luteinizing hormone (LH),~     estrone conjugates (E1C), and pregnanediol-3-glucuronide (PdG). Reproductive endpoints~     include menstrual disturbance, time to conception, spontaneous abortion, preterm delivery,~     and low birth weight.~   "
272872|NCT00023088|"~     The primary function of the Department of Rehabilitation Medicine (RMD) is to diagnose and~     treat patients at the NIH who have problems in locomotion, activities of daily living,~     occupational roles, communication, swallowing, or problems with chronic pain. The major goal~     of this department s to help patients achieve maximal function so that they can resume their~     daily living activities as normal as possible.~      In order for the department to accomplish it's goal it requires the involvement of medical~     staff and the use of a variety of tests and instruments. Before a new test, evaluation~     technique, or piece of physical equipment can be considered for use in the treatment of~     patients it must be carefully studied.~      Researchers must make sure the test, technique, or instrument is safe, sensitive, accurate,~     specific, and reproducible. Therefore all of these tests, techniques, and instruments must~     first undergo a trial period. Normal volunteers and patients from the RMD and outside of the~     RMD may be selected to participate in the trial period.~      This study provides a framework for researchers in the Department of Rehabilitation Medicine~     (RMD) to develop new tests, techniques, technology, and equipment.~   "
272873|NCT00023075|"~     This study will use a magnetic resonance imaging technique called nuclear magnetic~     spectroscopy (H-MRS) to define the pathology and progression of primary lateral sclerosis,~     hereditary spastic paraplegia and amyotrophic lateral sclerosis and assess the usefulness of~     this technique in evaluating patients' response to therapy. H-MRS will be used to examine~     metabolic changes in the parts of the brain and spinal cord (motor cortex and corticospinal~     tract) involved in movement.~      Normal volunteers and patients with primary lateral sclerosis, hereditary spastic paraplegia~     or amyotrophic lateral sclerosis between 21 and 65 years of age may be eligible for this~     study. Participants will have up to five H-MRS studies, including baseline and follow-up~     tests. For this procedure, the subject lies on a stretcher that is moved into a strong~     magnetic field. Earplugs are worn to muffle the loud knocking noise that occurs during~     switching of radio frequencies. The subject will be asked to lie still during each scan, for~     1 to 8 minutes at a time. Total scanning time varies from 20 minutes to 2 hours, with most~     examinations lasting between 45 and 90 minutes. Communication with the medical staff is~     possible at all times during the scan.~   "
272874|NCT00023062|"~     This study will use transcranial magnetic stimulation (TMS) to explore how the brain controls~     movement by sending messages to the spinal cord and muscles and what goes wrong with this~     process in disease. Activity in the motor cortex-the outer part of the brain-will be examined~     use TMS in patients with Parkinson's disease and in healthy volunteers.~      Normal volunteers and patients with Parkinson's disease (stage I to III) 21 years of age and~     older may be eligible for this study.~      All participants will have transcranial magnetic stimulation. For this procedure, an~     insulated wire coil is placed on the subject's scalp and a brief electrical current is passed~     through the coil. This creates a magnetic pulse that passes into the brain and generates very~     small electrical currents in the cortex, briefly disrupting the function of the brain cells~     in the stimulated area. This may cause muscle twitching or tingling in the face, jaw or limb.~     During the stimulation, participants will be asked to tense certain muscles slightly or~     perform other simple actions. The electrical activity of the muscle will be recorded on a~     computer through electrodes taped to the skin over the muscle. In most cases, the study will~     last less than 3 hours. Participants will also fill out questionnaires about aspects of~     personality and will be tested for their ability to perform certain cognitive (thinking) and~     movement tasks. Patients with Parkinson's disease will, in addition, be administered the~     Uniform Parkinson's Disease Rating Scale to measure disease severity.~      Patients will be requested to stop all Parkinson's disease medications 12 hours before the~     study. They may resume medications immediately after the study. Patients who so wish may be~     admitted to the hospital the day or evening before the study while they are off medications~     and stay there until they feel ready to leave.~   "
272875|NCT00023049|"~     This study will try to identify the genetic causes of hereditary hearing loss or balance~     disorders.~      People with a hearing or balance disorder that affects more than one family member may be~     eligible for this study. They and their immediate family members may undergo some or all of~     the following procedures:~        -  Medical and family history, including questions about hearing, balance and other~          ear-related issues, and review of medical records.~        -  Routine physical examination.~        -  Blood draw or buccal swab (brushing inside the cheek to collect cells) Tissue is~          collected for DNA analysis to look for changes in genes that may be related to hearing~          loss.~        -  Hearing tests The subject listens for tones emitted through a small earphone.~        -  Balance tests to see if balance functions of the inner ear are associated with the~          hearing loss In one test the subject wears goggles and watches moving lights while cold~          or warm air is blown into the ears. A second test involves sitting in a spinning chair~          in a quiet, dark room.~        -  Photograph A photograph may be taken as a record of eye shape and color, distance~          between the eyes, and hair color.~        -  Computed tomography (CT) and magnetic resonance imaging (MRI) scans These tests show the~          structure of the inner ear. For CT, the subject lies still for a short time while X-ray~          images are obtained. For MRI, the patient lies on a stretcher that is moved into a~          cylindrical machine with a strong magnetic field. The magnetic field and radio waves~          produce images of the inner ear. The radio waves cause loud thumping noises that can be~          muffled by the use of earplugs.~   "
272876|NCT00023036|"~     This study will try to identify and understand the genetic factors that lead to an inner ear~     malformation called enlarged vestibular aqueducts, that can be associated with hearing~     loss.~      Patients with sensorineural hearing loss with or without inner ear malformations and their~     parents and siblings may be eligible for this study. Participants and their immediate family~     members, may undergo some or all of the following tests and procedures:~        -  Medical and family history, including questions about hearing, balance and other~          ear-related issues, and review of medical records.~        -  Routine physical examination.~        -  Blood draw or buccal swab (brushing inside the cheek to collect cells) - Tissue is~          collected for DNA analysis to look for changes in genes that may be related to hearing~          loss.~        -  Hearing tests - The subject listens for tones emitted through a small earphone.~        -  Balance test (VEMP) to see if balance functions of the inner ear are associated with the~          hearing loss Electrodes will be placed behind your ear and at the base of your neck.~          From a reclining position, you will be asked to raise your head while clicking sounds~          are played into your ears. - Ultrasound tests - An inner ear malformation called EVA~          (enlargement of the vestibular aqueduct) indicates that a genetic disorder called~          Pendred syndrome may be the cause. Because thyroid abnormalities are also associated~          with Pendred syndrome, an ultrasound examination of the thyroid gland may be done.~        -  Computed tomography (CT) and magnetic resonance imaging (MRI) scans - These tests show~          the structure of the inner ear. For CT, the subject lies still for a short time while~          X-ray images are obtained. For MRI, the patient lies on a stretcher that is moved into a~          cylindrical machine with a strong magnetic field. The magnetic field and radio waves~          produce images of the inner ear. The radio waves cause loud thumping noises that can be~          muffled by the use of earplugs.~   "
272877|NCT00023023|"~     This study will follow blood transfusion recipients for 6 to 9 months following transfusion~     to monitor the quality and safety of blood transfusion. Improved viral testing and careful~     donor screening in the last several years has dramatically reduced the rates of~     transfusion-related HIV and hepatitis. Nevertheless, ongoing surveillance of~     transfusion-related infections is essential to maintain a high safety standard and to~     determine the transfusion risk of other infectious agents, such as cytomegalovirus,~     Epstein-Barr virus, parvovirus B-19, HHV-8 (Kaposi s sarcoma virus) and other possible~     hepatitis viruses that might be blood-transmitted. Transfused patients blood will be tested~     for various infectious agents. Their blood samples and blood samples from their donors will~     be frozen and stored in a repository so that any new infectious agent can be rapidly~     evaluated for its danger to the safety of the blood supply.~      Adult patients at the National Institutes of Health and children at the Children s National~     Medical Center who are scheduled to receive a blood transfusion or to undergo surgery for~     which a blood transfusion may be needed are eligible for this study.~      All participants will have a 20- to 25-milliliter (about 2 tablespoonfuls) blood sample drawn~     before their transfusion and again at 1, 2, 3 and 6 months after the transfusion. Patients~     who are transfused on more than one occasion over the course of the study will provide three~     additional monthly samples. Patients who develop a transfusion-transmitted infection during~     the study will provide up to four more samples to study the infection and its effects.~     Participants will complete a brief questionnaire at the end of the study regarding prior~     blood transfusions and the development of any illnesses, such as hepatitis, that might have~     been caused by the transfusion.~   "
272891|NCT00022841|"~     The purpose of this study is to determine whether the drug pamidronate can safely and~     effectively improve bone mineral density in growing children who have bone disease caused by~     taking steroid medications. People who take steroid medications called glucocorticoids, like~     prednisone or dexamethasone, for long periods almost always have decreased bone density and~     are at increased risk of breaking a bone. Research has shown that pamidronate improves bone~     density in adults who take glucocorticoids. However, use of pamidronate is not approved in~     children because it has not been extensively tested in children. It is possible that children~     will have a different response or unique problems with the medication because their bones are~     still growing. We will assign all study participants to one of two groups. One group will~     receive pamidronate intravenously (through a vein) every 3 months in addition of daily oral~     calcium and vitamin D and the other group will receive calcium and vitamin D. The study is~     scheduled to run for 36 months, with visits to the study center once every 3 months.~   "
272878|NCT00023010|"~     This study will provide long-term monitoring of two patients who received gene therapy for~     leukocyte adherence deficiency (LAD) under the Food and Drug Administration investigational~     new drug study BB-IND-7949. The IND protocol has been closed. No other patients are eligible~     for this study.~      Patients previously enrolled in BB-IND-7949 (Retrovirus-Mediated Transfer of the cDNA for~     Human CD18 into Peripheral Blood Repopulating cells of Patients with Leukocyte Adherence~     Deficiency) will be followed at least yearly for an indefinite period of time to evaluate~     their medical status and look for treatment side effects. The follow-up visits at the NIH~     Clinical Center will involve the following:~        -  Interview regarding health status during the past year~        -  Blood draw of approximately 15 milliliters for 3 years, then 5 ml annually thereafter~          for studies related to LAD and to make sure no unexpected effects of gene therapy have~          occurred~      The blood samples collected at the follow-up visits will be frozen and stored. If a serious~     medical problem arises, the sample may be checked for replication competent virus. If the~     gene therapy is suspected to be related to a medical problem, investigation may include a~     review of the patient's medical records or collection of additional blood or tissues for~     testing. If the patient should die, the family will be asked permission to perform an~     autopsy, regardless of the cause of death. Tissues taken at autopsy will be tested for any~     long-term effects from the gene therapy.~   "
272879|NCT00022997|"~     This study will explore the genetics of taste and taste deficits. The sense of taste plays a~     crucial role in food choices, allowing people to identify beneficial foods (those with high~     caloric value, which are typically sweet) and foods likely to be toxic (usually bitter~     substances). The loss of sense of taste in older people plays a role in decreased appetite~     and poor nutrition. Taste deficits may adversely affect people in ways that are not well~     understood. This study will examine why some people (about one-fourth of all people in the~     United States) cannot taste a substance called phenylthiocarbamide (PTC). The inability to~     taste PTC is due to inherited factors that are not yet clear.~      Individuals age 18 and older who can taste PTC and individuals who cannot taste PTC may be~     eligible for this study. Participants will taste a number of liquid solutions until they find~     one with a clear taste. Then they will taste another group of solutions and decide which ones~     have that taste and which have no taste. Finally, they will taste a third group of solutions~     until they find one with a different taste. About 2 tablespoons of blood will be drawn from~     participants for genetic tests related to the sense of taste.~   "
272880|NCT00022984|"~     This study will explore how people with an implanted cardioverter defibrillator (ICD) feel~     that dependence on this life-saving technology affects their health-related quality of life.~     ICD therapy is an important treatment option for patients with serious recurrent abnormal~     heart rhythms. Overall survival is significantly improved in high risk patients who receive~     this therapy. This study will explore patients' perceptions of the impact of this device on~     their health status and well being, and their physical, psychological and social functioning.~      Patients 18 years of age or older who have an implanted cardioverter defibrillator may be~     eligible for this study.~      Participants will fill out a questionnaire booklet containing 170 questions about how they~     feel about their health, including their concerns and stresses, feelings about dependency on~     life-saving technology, and illness perception. There are also questions on demography, such~     as age, marital status, employment, etc. The booklet may take up to 30 minutes to complete.~      Information obtained from this study may lead to a better understanding of how people feel~     about their health after receiving an ICD and help patients and families adapt to living with~     the device.~   "
272881|NCT00022971|"~     This study will evaluate the safety and effectiveness of a combination of two antibodies,~     apolizumab and rituximab (Rituxan ), in treating B-cell lymphomas and chronic lymphocytic~     leukemia. Rituximab attaches to a molecule called CD20 on B-cell lymphomas and can cause~     significant shrinkage of these tumors in up to half of patients. However, it does not cure~     the lymphoma, which usually returns. Also, it is not as effective against leukemia.~     Apolizumab attaches to a protein called 1D10 on B-cell cancers and has also been able to~     shrink tumors in some patients. There is little experience apolizumab in patients with~     leukemia. This study will test whether the two antibodies together are more effective against~     these tumors than either one alone.~      Patients 18 years and older with B-cell lymphoma or chronic lymphocytic leukemia may be~     eligible for this study. Patients' leukemia or lymphoma cells must have both the CD20 and~     1D10 antigen receptors and must have had at least one systemic treatment for their disease.~     Candidates are screened with a medical history and physical examination, blood and urine~     tests, electrocardiogram, x-rays and other imaging studies, and possibly a bone marrow~     aspirate (withdrawal of a small marrow sample through a needle inserted into the hip bone)~     and lumbar puncture (withdrawal of a small sample of cerebrospinal fluid-fluid that bathes~     the brain and spinal cord-through a needle placed between the bones in the lower back).~      Participants receive infusions of rituximab and apolizumab once a week for 4 weeks. The first~     patients in the study receive lower doses of apolizumab with standard doses of rituximab. If~     the apolizumab is well tolerated, subsequent patients are given higher doses. Patients are~     also given dexamethasone or another similar steroid, diphenhydramine (Benadryl ), and~     acetominophen (Tylenol ) to reduce reactions to the antibodies. After 4 weeks of treatment,~     patients are followed frequently to examine the response to treatment and evaluate drug side~     effects. Patients whose tumors do not grow during the 4 weeks of therapy may be offered~     another course of treatment at a later time. Participants are followed periodically after~     treatment ends until their disease worsens or the study ends.~   "
272882|NCT00022958|"~     The primary objective of this study is to make Iodine-131 Anti-B1 Antibody more broadly~     available to patients. Secondary endpoints of the study will be to obtain additional~     information on the efficacy and safety of Iodine-131 Anti-B1 Antibody.~   "
272883|NCT00022945|"~     The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody followed by~     CHOP and to see what effects it has on patients with previously untreated mantel cell~     lymphoma.~   "
272884|NCT00022932|"~     The purpose of this study is to determine the safety and effectiveness of using Iodine-131~     Anti-B1 Antibody for the treatment of patients with large B-cell non-Hodgkin's lymphoma (NHL)~     who have achieved a response following 6-8 cycles of CHOP therapy.~   "
272885|NCT00022919|"~     This study will examine prostate tumor tissue cultures to try to identify genetic~     abnormalities that contribute to the cause or progression of the disease.~      Patients with prostate cancer enrolled in the National Cancer Institute protocol 97-C-0147~     (Collection of Serum and Tissue Samples from Patients with Biopsy-Proved or Suspected~     Malignant Disease) may be eligible for this study.~      Specimens for tissue culture for this study will be obtained from tumors surgically removed~     from patients participating in NCI protocol 97-C-0146.~      The findings of this study may lead to better methods of predicting the course of disease in~     individual patients.~   "
272886|NCT00022906|"~     The purpose of this study is to determine the proper dose, effectiveness, and safety of using~     Iodine-131 Anti-B1 Antibody for the treatment of patients with previously treated~     non-Hodgkin's lymphoma (NHL) who have greater than 25% bone marrow involvement with lymphoma.~   "
272892|NCT00022828|"~     The goal of this research project is to develop a new system that uses lasers to provide~     3-dimensional (3-D) images of the cervical spine (the seven spinal bones in the neck) in a~     moving person. Doctors and researchers could use this system to examine people with spinal~     disorders and to learn more about how the spine works. The laser technique would be better~     than existing imaging methods because it would provide 3-D views of the cervical spine and~     would not expose patients to radiation. These two features would make a laser system a safer~     and more effective tool than other imaging systems. This technique should be suitable for a~     wide variety of uses because the sensitivity of the measurement can be adjusted depending on~     what is being studied. The benefits of this research will include helping doctors and other~     health practitioners to detect and diagnose painful spinal disorders more effectively. This~     should lead to improved treatment and management of spinal disorders.~   "
272893|NCT00022815|"~     This study will test the safety of a new treatment method called tissue ultrafiltration. We~     will test this method in the treatment of compartment syndrome, a condition that occurs when~     pressure within the muscles builds to dangerous levels. In the legs and other parts of the~     body, a tough, stiff membrane covers groups of muscles and the nerves and blood vessels that~     run next to and through them. The entire unit is called a compartment. The causes of~     compartment syndrome include traumatic leg injuries and loss of blood supply. In tissue~     ultrafiltration, a doctor places hollow probes, or catheters, directly into the muscle~     compartment in the injured area of the lower leg. The probes remove fluid from the~     compartment (extra fluid can cause increased pressure).~      We will do an initial safety study in a group of patients who have had surgery for a broken~     tibia (the inner, larger bone of the lower leg) and are at high risk for developing~     compartment syndrome. The goals of this initial study are to show that inserting tissue~     ultrafiltration catheters in the muscle compartment is safe and can be done repeatedly~     without problems; to show that tissue ultrafiltration can be used to monitor the biochemical~     environment inside tissues; and to show that the catheter apparatus provides an accurate~     measurement of pressure in the compartment.~   "
272894|NCT00022802|"~     This project focuses on the further development and clinical testing of an image-guided~     surgical system. The system will help surgeons perform procedures that involve inserting a~     screw, guide pin, drill bit, or other straight object into bone-for example, inserting screws~     in a broken hip bone. These surgeries are currently done with the help of a mobile x-ray~     device called a C-arm, which provides the surgeon with x-ray images during the procedure.~      C-arms have some disadvantages, including image distortion, radiation exposure, and the need~     for time-consuming adjustments of the C-arm during the surgery. The new method would deal~     with these shortcomings with a computer-based system that adds to the existing C-arm system.~     It would provide the surgeon with a real-time view of the insertion process, and could~     improve the accuracy and speed of certain surgical procedures.~      Disadvantages associated with C-arms include image distortion, radiation exposure, and time~     consuming reconfiguration of the C-arm during the insertion process. The proposed system~     would address these shortcomings with a computer-based system that augments the existing~     C-arm system.~   "
272895|NCT00022776|"~     Lumbar spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the~     spinal cord and/or nerve roots) is a condition that occurs frequently, particularly in the~     elderly. This condition can lead to significant pain and limit a person's ability to~     function. Moreover, doctors disagree about the best way to treat people with lumbar spinal~     stenosis.~      In this study we will compare surgical treatment of lumbar spinal stenosis with nonsurgical~     treatment using physical therapy. The results of this study should help clarify which~     treatment strategies are the most effective for patients with lumbar spinal stenosis.~   "
272896|NCT00022789|"~     To investigate the prevalence and clinical significance of sleep-disordered breathing (SDB)~     in children.~   "
272897|NCT00022750|"~     Diabetes mellitus imposes a major burden on the public health of the United States, leading~     annually to over 300,000 deaths and over $130 billion in costs. This burden falls~     disproportionately upon ethnic minority groups, particularly African Americans, who are at~     excess risk for the development of type 2 diabetes and for a variety of its most serious~     complications. Suboptimal health care - in terms of access, quality, and adherence -appears~     to be an important contributing factor. Prior work suggests two possible approaches aimed at~     prevention to enhance risk factor control in outpatients with type 2 diabetes. One approach~     uses Nurse Case Managers (NCMs) to coordinate care plans with the provider team following~     protocols/clinical guidelines and algorithms designed to guide treatment including initiating~     and adjusting drug therapy, enhancing continuity of care, promoting interventions and~     self-management which include educational and behavioral strategies incorporating feedback~     and self-regulation. Another approach uses Community Health Workers (CHWs) to enhance~     culturally sensitive outreach, linkage, and monitoring service; to provide important patient~     and family education; and to improve access to and continuity of care. Results indicate that~     this intensive team approach, compared to usual care alone, produces substantial improvements~     in metabolic control. However, the cost-effectiveness of such interventions is unknown in the~     ''real-world''.~      This has led to our current study, a randomized controlled trial within a managed care~     organization to determine the effects of a NCM/CHW team on metabolic control, on the~     occurrence of diabetes-related health events, health care utilization, and on direct health~     care costs. The participants will be African American adults with type 2 diabetes who receive~     primary care within a managed care organization in inner-city Baltimore.~   "
272898|NCT00021970|"~     To determine the effects of four treatments (placebo, a vitamin E and C regimen, a hormone~     replacement regimen, and a combined vitamin/hormone replacement regimen) on specific markers~     of oxidative damage in coronary arteries of postmenopausal women.~   "
272899|NCT00021957|"~     To determine the value of serum markers as surrogate endpoints and hemodynamic biomarkers of~     congestive heart failure.~   "
272900|NCT00021944|"~     To test whether novel cardiovascular risk factors are related to the presence and development~     of atherosclerosis and macrovascular events in Type 2 diabetes mellitus and to determine~     whether intensive glucose lowering therapy will reduce the levels of these cardiovascular~     risk factors.~   "
272901|NCT00021931|"~     To examine the cellular and molecular mechanisms of corticosteroid and leukotriene receptor~     antagonists, focusing on their effects on T lymphocytes during both chronic (18 months) and~     acute therapy.~   "
272902|NCT00021918|"~     To examine the independent association of serum total homocysteine and C-reactive protein~     with arteriosclerotic cardiovascular disease morbidity and mortality.~   "
272903|NCT00021905|"~     To assess the risk of incident atrial fibrillation after stopping anti-hypertensive~     medication including beta-blockers and ACE inhibitors. Also, to assess the role of genetics~     in subsequent risk of stroke among patients with atrial fibrillation.~   "
272907|NCT00021853|"~     This study will evaluate the effect of motor training on focal hand dystonia in people with~     writer's cramp and will examine whether this training affects excitability of the motor~     cortex of the brain. In dystonia, muscle spasms cause uncontrolled twisting and repetitive~     movement or abnormal postures. Focal dystonia involves just one part of the body, such as the~     hand, neck or face. Patients with focal hand dystonia have difficulty with individualized~     finger movements, which may be due to increased excitability of the motor cortex.~      Patients with hand dystonia 21 years of age or older may be eligible for this 2-month study.~     Those taking botulinum toxin injections must stop medication 3 months before entering the~     study.~      Participants will undergo a complete neurologic examination. They will undergo motor training~     with constraint-induced movement therapy. This therapy involves constraining some fingers~     while allowing others to move. Participants will have the following tests and procedures at~     baseline (before motor training), after 4 weeks of motor training, and again after 8 weeks:~        -  Handwriting analysis - A computerized program evaluates the degree of automatic~          movements the patient uses in writing, as well as writing pressure and speed.~        -  Symptoms evaluation - Patients fill out a written questionnaire about symptoms and rate~          their improvement, if any, after training.~        -  Transcranial magnetic stimulation - The patient is seated in a comfortable chair, and an~          insulated wire coil is placed on the scalp. Brief electrical currents pass through the~          coil, creating magnetic pulses that travel to the brain. These pulses generate very~          small electrical currents in the brain cortex, briefly disrupting the function of the~          brain cells in the stimulated area. The stimulation may cause muscle twitching or~          tingling in the scalp, face, arm or hand. During the stimulation, the patient is asked~          to slightly tense certain muscles in the hand or arm or perform simple actions.~          Electrodes are taped to the skin over the muscles activated by the stimulation, and the~          electrical activity in the muscles will be recorded with a computer.~        -  Electroencephalogram (EEG) - Wire electrodes are taped to the scalp or placed on a Lycra~          cap the patient wears to record the brain's electrical activity.~      Participants will have 50-minute motor training sessions 3 times during the first week of the~     study, twice the second week and once each in weeks 3 and 4. In addition, they will be~     required to practice the training at home for 25 minutes each day during week 1 and 50~     minutes each day for the remaining 3 weeks. Fingers not being trained will be splinted.~   "
272908|NCT00021840|"~     To identify genetic factors that influence the development of asthma in Hispanics.~   "
272909|NCT00021827|"~     PTH-related protein, or ''PTHrP'', is a hormone which was discovered in 1987. As its name~     implies, it is closely related to another hormone discovered in the 1920's named parathyroid~     hormone or ''PTH''. PTH has been shown to be effective in treating osteoporosis in both~     animals and humans. PTHrP has been shown to be effective in treating osteoporosis in~     laboratory animals, and there are strong scientific reasons to think that it may be effective~     in humans as well. However, no human trials with PTHrP in the treatment of osteoporosis have~     been performed. The studies in this trial are focussed on determining whether PTHrP can~     indeed increase bone mass in postmenopausal women with osteoporosis, when administered daily~     by subcutaneous injection for three months.~   "
272910|NCT00021814|"~     The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by~     the National Institutes of Health (NIH). The study will test whether the oral drugs~     finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent~     further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH).~      MTOPS is the largest and longest study to simultaneously test whether these drugs can delay~     or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical~     centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March~     1998. Study doctors will continue to follow these men through November 2001 on a quarterly~     basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of~     prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality~     of life.~   "
272911|NCT00021801|"~     The goal of islet cell transplantation in Type 1 diabetics is to provide those affected with~     constant normal blood glucose levels, thereby reducing or eliminating altogether the need for~     injected insulin. This normalization may prevent or slow progression of diabetic~     complications, result in a healthier lifestyle, and lead to a better quality of life.~      Participants who meet the inclusion criteria will undergo an extensive screening process~     which typically includes a series of blood tests, EKG, chest x-rays, and a psychological~     evaluation, among others. Those who are eligible for and chose to participate in the trial~     will receive an islet cell transplant and bone marrow infusion from the same donor, together~     with following immunosuppressive medications: tacrolimus, sirolimus, daclizumab and~     infliximab. Because the bone marrow infusion may successfully prevent the transplanted islet~     cells from rejecting, some participants may be able to stop taking the immunosuppressive~     medications after a year.~      The islet cell transplant is done under local anesthesia in a special procedure radiology~     room. Several days after the islet cell transplant, the participant is admitted to the~     hospital as an outpatient in order to receive bone marrow via a simple intra-venous infusion~     procedure.~      All participants will need to be seen at the Diabetes Research Institute after the transplant~     for follow-up testing and post-islet cell transplant care.~   "
272912|NCT00021788|"~     The goal of islet cell transplantation in patients with Type 1 Diabetes Mellitus is to~     provide constant normal blood glucose levels. This may eliminate the need for insulin~     altogether or provide a significant reduction in the amount of insulin necessary to maintain~     constant normal blood glucose levels. This normalization may prevent or slow progression of~     diabetic complications. Furthermore, the participant may enjoy a healthier lifestyle and a~     better quality of life.~      If you meet the initial inclusion criteria for the trial, you must be able to give informed~     consent personally. Then you will need to participate in an extensive screening process that~     involves many standard tests and collection of laboratory samples to make sure that the~     transplant is suitable and safe for you.~   "
272913|NCT00021749|"~     This non-randomized study will test the safety and effectiveness of Genasense in patients~     with CLL.~   "
272914|NCT00021736|"~     The purpose of the study is to determine whether the anti-VEGF drug is effective at~     stabilizing and/or improving vision in patients with the wet form of AMD~   "
272915|NCT00021723|"~     A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot~     efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's~     disease.~   "
272945|NCT00018668|"~     Motor slowing is a hallmark, clinical sign in mental illness. Slowness can be related to a~     specific disease process, as in negative schizophrenia or depression or it can be the result~     of medications used to treat forms of mental illness. Prior research has lead to a novel~     instrumental approach for distinguishing subtypes of motor slowing - one type related to~     cognitive processes and another related to parkinsonism. The purpose of this study is to test~     whether new medications used to treat schizophrenia improve the cognitive or parkinsonian~     components of motor slowing. Patients will be studied in the laboratory before and 8-weeks~     after starting a new antipsychotic. The n of this study = 60 patients. The results of this~     study will improve our understanding of the complex interactions between cognitive processing~     and motor behavior in patients with psychotic illnesses and how drugs work to treat these~     problems.~   "
272916|NCT00021710|"~     This study will try to elucidate learning processes associated with motor training in the~     weak arm of stroke patients compared with healthy controls. Results from previous clinical~     trials indicate that training may enhance motor function in healthy volunteers, and perhaps~     also in stroke patients, even more than 1 year after the stroke. Normal, healthy volunteers~     and stroke patients 18 years of age and older may be eligible for this study.~      Study subjects will have a physical examination and participate in 6 additional clinic~     visits-training and testing sessions on study days 1, 2, 3, 4 and 5, and a final testing~     session on day 12. During these sessions, they will perform a series of motor tasks,~     including writing, picking up objects, turning cards, stacking checkers and moving cans,~     which will be timed and videotaped. Each session will be divided into blocks of 10 trials for~     each task, separated by 2-minute rest periods.~      Before and after training on days 1, 2, 5 and 12, subjects will have transcranial magnetic~     stimulation (TMS) to determine brain changes associated with learning a motor task. For this~     procedure, the patient is seated in a comfortable chair, and an insulated wire coil is placed~     on the scalp or skin. A brief electrical current is passed through the coil, creating a~     magnetic pulse that stimulates the brain. These pulses generate very small electrical~     currents in the brain cortex, briefly disrupting the function of the brain cells in the~     stimulated area. The stimulation may cause muscle twitching or tingling in the scalp, face,~     or limb. During the stimulation, the subject may be asked to slightly tense certain muscles~     or perform other simple actions.~      Electrical nerve stimulation and electromyography will be done to record muscle responses to~     stimulation. A nerve is stimulated by placing wires on the skin over the nerve and passing a~     brief electrical current between the wires. Electromyography involves taping metal electrodes~     to the skin over the muscle.~      Before and after each session, subjects' muscle strength will be tested with a pinch gauge.~     They will also be asked to make a mark on a line drawn on paper, to rate their test~     performance and levels of attentiveness and fatigue.~   "
272917|NCT00021697|"~     The purpose of this study is to compare and evaluate the safety of AVP-923~     (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.~   "
272918|NCT00021658|"~     Exposure and health study of pesticide and allergen exposures to pregnant women and children.~     Intervention study is planned after assessment is completed.~   "
272919|NCT00021645|"~     This study will evaluate whether vitamin E can help treat swelling of the macular area of the~     retina (the back part of the eye) associated with uveitis (inflammatory eye disease). The~     macula is responsible for sharp vision; swelling in this area is one cause of vision loss in~     uveitis patients. Macular swelling is also associated with eye problems related to diabetes.~     In these patients, the swelling is thought to be caused by a substance called vascular~     endothelial growth factor, or VEGF. High doses of vitamin E have been used to treat these eye~     problems in diabetics. This study is a first step to find out if vitamin E will help reduce~     the retinal swelling in uveitis, which may also be caused by VEGF.~      Patients 9 years of age and older with macular edema associated with uveitis may be eligible~     for this study. Candidates will be screened with the following tests and procedures:~        -  Medical history and physical examination. This includes measurement of vital signs~          (blood pressure, pulse, temperature and breathing rate) and examination of the head and~          neck, heart, lungs, abdomen, arms and legs.~        -  Eye examination. This includes measurement of visual acuity using a vision chart,~          measurement of eye pressure and examination of the pupils and eye movements. The pupils~          will be dilated with drops to permit examination of the back of the eye.~        -  Fluorescein angiography. This test uses a yellow dye (fluorescein) to take photos of the~          retina. The fluorescein is injected into an arm vein and travels to the blood vessels in~          the eye. The camera flashes a blue light into the eye and takes pictures of the retina.~          The pictures show if the dye has leaked from the blood vessels into the retina.~        -  Stereoscopic color fundus photography. These are photographs of the back of the eye,~          taken after the pupils have been dilated with drops.~        -  Optical coherence tomography. This test measures the macular swelling. It is used to~          determine if the swelling is getting worse, better or staying the same.~        -  Blood tests. About a tablespoon of blood is drawn to measure inflammation and cell~          counts and side effects of treatment.~        -  Pregnancy test. All women of child-bearing potential are tested for pregnancy.~      Participants will be randomly assigned to daily treatment with oral high-dose vitamin E (1600~     units) or placebo (a pill with no active ingredient) for 4 months. They will be examined at 2~     months and 4 months with the same tests performed for screening and will return for a final~     clinic visit 1 month after treatment has ended.~   "
272920|NCT00021580|"~     The experience of the Edmonton Group with islet transplantation and use of the Edmonton~     Protocol provides much promise for T1DM patients. However, the need to use 2 or more donor~     pancreases to achieve freedom from insulin shots limits the widespread use of this protocol.~     Two classes of oral antidiabetic drugs improve insulin action and reduce the amount of~     insulin needed to have normal blood sugars. The first part of the proposed project (Group 1)~     will use these drugs in conjunction with the Edmonton Protocol to allow for successful islet~     transplantation from islets isolated from a single pancreas.~      The Edmonton Protocol is a treatment, not a cure. It requires the long-term use of powerful~     immunosuppressive drugs that are expensive and increase the risk of infection and cancer.~     T1DM patients who have a functioning kidney transplant already have to use immunosuppressive~     drugs, and they are still at risk of recurrent diabetic kidney disease and other~     complications of diabetes. Islet transplantation in these patients has only rarely been~     successful in the past in part because the usual immunosuppressive drugs used in kidney~     transplantation cause diabetes and actually harm the transplant kidney in other ways. The~     immunosuppressive drugs used in the Edmonton Protocol are less likely to cause diabetes and~     are also less harmful to the kidney. In the second part of this project (Group 2), we will~     transplant islets into kidney transplant patients after they have switched to the~     immunosuppressive medications used in the Edmonton Protocol. Even if some of the patients do~     not get islet transplants or still need insulin shots after islet transplantation, we expect~     to see improvement in kidney function and blood glucose control.~   "
272921|NCT00021567|"~     This study will test the safety and effectiveness of inhaled interferon gamma-1b and oral~     antibiotics for treating mycobacterium avium complex (MAC) infection of the lungs.~      Patients 18 years of age or older with MAC infection of the lungs who 1) have been previously~     treated for MAC, or 2) have moderate or severe lung disease due to MAC that has not been~     previously treated may be eligible for this study.~      Participants will be randomly assigned to one of two treatment groups. Group 1 will receive~     500 micrograms of interferon gamma-1b 3 times a week for 48 weeks by inhalation. Group 2 will~     inhale a placebo (inactive substance) according to the same regimen. In addition, all~     patients will receive standard MAC treatment with three antibiotics-clarithromycin or~     azithromycin, ethambutol and rifampin or rifabutin-taken by mouth times a week.~      Patients will come to the clinic for a screening visit, baseline visit, 1 month after~     beginning treatment, and at 3-month intervals thereafter until the end of the study. During~     these various visits, they will undergo the following tests and procedures:~        -  Medical history and physical examination, including height and weight measurements,~          heart rate, breathing rate, blood pressure and temperature~        -  Possibly computed tomography (CT) and X-ray of the lungs~        -  Sputum sample~        -  Pulmonary function studies~        -  Blood and urine tests~      Patients' eyes will be examined monthly to check for side effects of ethambutol, and hearing~     and balance will be tested to check for side effects of clarithromycin or azithromycin.~      At the baseline visit, the patient or caretaker will be trained to use a nebulizer (a special~     breathing device) to take the study medication.~   "
272946|NCT00018655|"~     This study is a randomized clinical trial comparing outcomes of Integrated Cognitive~     Behavioral Treatment plus standard medications for veterans with both substance use~     disorders, depressive disorders versus the most commonly administered form of therapy for~     substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group~     treatment plus medications.~   "
272922|NCT00021541|"~     This study will examine whether the experimental drug R115777 (Tipifarnib) can shrink or slow~     the growth of plexiform neurofibromas in children and young adults with neurofibromatosis~     type 1 (NF1) and determine what side effects are related to treatment. Plexiform tumors arise~     from nerves; the only effective treatment is surgical removal. Often, however, not all the~     tumors can be removed, because of their number or location.~      Patients with NF1 have a reduced amount of the protein neurofibromin. Neurofibromin is~     thought to help control the activity of another protein, called ras, which regulates cell~     growth. Too little neurofibromin, therefore, may allow for uncontrolled cell growth and tumor~     formation. R115777 interferes with the function of the ras and other proteins. In test tube~     and animal studies, R115777 has blocked the growth of cancer cells. This study will examine~     whether the drug is effective against plexiform tumors.~      Patients with NF1 and progressive plexiform neurofibromas between 3 and 25 years of age may~     be eligible for this study. Patients whose tumors can be successfully removed surgically may~     not participate in this study. Candidates are screened with a medical history and physical~     and eye examinations, blood and urine tests, and magnetic resonance imaging (MRI).~     Photographs are taken of tumors visible on the body surface.~      Study participants are randomly assigned to receive either R115777 or placebo (an inactive~     substance). They take R115777 or placebo tablets every 12 hours for 21 days, followed by a~     7-day rest period. This constitutes one 28-day treatment cycle. Treatment continues for as~     long as the tumors remain stable or shrink and side effects are tolerable. The treatment is~     switched (for example, from placebo to R115777) or stopped if the tumors grow or if side~     effects become unacceptable. Patients (or their parents) keep a record of side effects.~      For the first 3 treatment cycles, patients have a physical examination and blood tests every~     other week. Blood tests are also done before starting treatment, and at one time point after~     at least 14 days of treatment to measure the effect of R115777 on proteins in blood cells. A~     blood sample is obtained before starting treatment and before cycles 4, 7 and 10 and then~     after every 6 cycles to measure the level of a substance called nerve growth factor. The~     analysis of nerve growth factor is used to determine if it can predict which patients might~     be at risk of developing side effects from R115777.~   "
272923|NCT00021528|"~     STAR*D focuses on non-psychotic major depressive disorder in adults who are seen in~     outpatient settings. The primary purpose of this research study is to determine which~     treatments work best if the first treatment with medication does not produce an acceptable~     response. Participants will first receive citalopram, an SSRI medication; if symptoms remain~     after 8-12 weeks of treatment, up to four other levels of treatment will be offered,~     including cognitive therapy and other medications. There are no placebo treatments. Some~     patients may require a combination of two or more treatments to obtain full benefit.~     Participation could last from 15 to 27 months and involve up to 30 clinic visits.~     Participants will be interviewed by telephone throughout the study about their symptoms,~     daily functioning, treatment side effects, use of the health care system, and satisfaction~     with treatment. There will be a one-year follow up for participants once their depression has~     been successfully treated~   "
272924|NCT00021502|"~     To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene~     conjugate (PHP) administered by continuous intravenous (IV) infusion in systemic inflammatory~     response syndrome (SIRS) patients with shock. PHP is a human-derived chemically modified~     hemoglobin preparation. PHP selectively scavenges excess nitric oxide (NO) and does so in a~     catalytic, concentration-dependent reaction that results in the formation of the non-toxic NO~     metabolite, nitrate. PHP is postulated to reduce excess, toxic levels of NO while allowing~     critical beneficial levels of the molecule to persist.~   "
272925|NCT00021476|"~     This study is aimed at developing ways to prevent acute pain from becoming chronic~     pain--specifically, pain associated with whiplash-associated disorders (WADs) from motor~     vehicle accidents. Research on the development of chronic pain due to musculoskeletal injury~     suggests that a person's initial emotional reactions, particularly fear of reinjury and~     subsequent avoidance of activity, contribute significantly to chronic pain and persistent~     disability. This study will treat people with WADs during the first three months after a~     motor vehicle accident with a behavioral and physical exercise program designed to encourage~     activity and discourage continued fear of movement, pain, and disability. The study will~     compare the effectiveness of two anxiety-reduction treatments to standard care in reducing~     pain and activity limitations in people with WADs in the 2 to 3 months after motor vehicle~     accidents.~   "
272926|NCT00021437|"~     Since 1960, persons with the very rare disorder Bloom's syndrome (BS) have been followed~     clinically, documenting clinical matters as obtained from their doctors. This has been a~     worldwide search for cases, though a few in the New York City area are seen (personally, by~     us) perhaps once every 2-3 years. BS is a rare genetically-determined disorder described in~     NYC in 1954. The clinical courses of the 169 persons diagnosed BS by 1991 are followed in a~     program referred to as the Bloom's Syndrome Registry. BS is the prototype of the~     chromosome-breakage syndromes. BS cells mutate at a greater rate than any other, and the~     consequence is the greatest known predisposition to cancers of the types that affect the~     general human population. We are defining the clinical syndrome and at the same time are~     studying cells from affected families in the experimental laboratory. BS is a model for~     learning about cancer. Our contact with families lets us know of cancers arising, but blood,~     and sometimes tiny biopsies of skin, is taken if available so that (a) the chromosomes can be~     studied and (b) the gene mutations can be defined in molecular terms.~   "
272927|NCT00018902|"~     The purpose of the study is to determine how best to treat adolescents with depression that~     is resistant to the first SSRI antidepressant they have tried. Participants receive one of~     three other antidepressant medications, either alone or in combination with cognitive~     behavioral therapy.~   "
272928|NCT00018889|"~     The goal of this protocol is to identify families with inherited movement disorders and~     evaluate disease manifestations to establish an accurate clinical diagnosis by using newest~     technological advances and investigate the underlying molecular mechanisms. Studies of~     inherited movement disorders in large families with good genealogical records are especially~     valuable. Patients with diseases of known molecular basis will be genotyped in order to~     investigate phenotype/genotype correlation. Patients with disease of unknown or incomplete~     genetic characterization will be studied with a hope of contributing to the identification of~     specific disease-causing genes and genetic mechanisms responsible for a specific disorder.~   "
272947|NCT00018642|"~     The purpose of this research study is to determine whether a new drug for schizophrenia is~     better for the maintenance treatment than a standard drugs currently prescribed. The new~     medication is called quetiapine and it will be compared with a standard medication called~     haloperidol decanoate. The study will determine if quetiapine causes fewer problems than~     haloperidol with side effects such as stiffness and restlessness and whether it costs the VA~     more or less to treat patients with quetiapine. In addition, blood samples will be collected~     every three months to determine if certain chemicals in the blood can influence the outcome~     of the subjects' illness.~   "
272948|NCT00018629|"~     The purpose of this study is to determine if Cognitive - Behavioral Social Skills Training~     (CBSST) improves functioning in older patients with schizophrenia.~   "
272929|NCT00018876|"~     More than 10,000 people each year in the United States have failed back surgery syndrome~     caused by scars that form around the outer surface of the spinal cord. Such scarring, known~     as peridural fibrosis, is common after back surgery known as either lumbar discectomy or~     laminectomy. Peridural fibrosis may cause recurring low back pain or leg pain after surgery.~     Operating again to remove the scar tissue often leads to more scarring.~      Researchers have not previously studied radiation as a way to prevent peridural fibrosis. We~     will test whether low-dose radiation given 24 hours before surgery will decrease the amount~     of peridural fibrosis and if this reduction will lead to improved results of surgery. Half of~     the participants will receive radiation before surgery and the other half will not. We will~     evaluate patients at followup visits 1, 3, 6, and 12 months after surgery with a physical~     exam and questionnaire. At 12 months, we will obtain magnetic resonance imaging (MRI) of the~     lower spine.~   "
272930|NCT00018863|"~     This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in~     very young children. The medication being used is methylphenidate (Ritalin); it is being~     studied to determine its safety and how well it works to treat ADHD in preschool-age children~     (3-5.5 year olds).~   "
272931|NCT00018850|"~     The target groups in this study are brain waves and neurotransmitters (chemical messengers)~     in the brain. Subjects with diagnosed with schizophrenia will be studied. The study will help~     understand more about normal brain functioning and how that functioning differs in people~     with schizophrenia. Another purpose of this study is to determine how the altered brain~     functioning in schizophrenia contributes the symptoms found in the illness.~   "
272932|NCT00018837|"~     The goal of this research program is to implement a series of psychoeducational training~     classes designed to teach individuals with schizophrenia the importance of medication~     treatment, how to identify and manage medication side effects, and how to make appointments~     and emergency plans. The skills taught to the research subjects will lead to demonstrable~     increases (compared to the control group) in adherence to both the prescribed medication~     regimen and scheduled outpatient appointments and thereby cause a decrease (again compared to~     the control group) in rehospitalization rates and bed-days during subsequent twelve months~     following the intervention. A secondary objective of this work is that if the CREP program is~     successful and/or illness education is effective, the data will be able to disseminated~     throughout the VISN 22 via the recently awarded Mental Illness Research Education and~     Clinical Center (MIRECC) program.~   "
272933|NCT00018824|"~     The purpose of this study is to test the efficacy combining a treatment for depression with a~     treatment for alcohol dependence.~   "
272934|NCT00018811|"~     Subjects with chronic migraine or tension headaches will receive 12 sessions of biofeedback~     or relaxation training after fulfilling screening, intake interviews, & psychological testing~     requirements. They will chart headache pain, anger level, & medication usage throughout~     baseline, treatment, and 3 month follow-up periods.~      Migraine sufferers will receive a combination of progressive muscle relaxation training and~     thermal biofeedback (learning to warm hands). Subjects are randomly assigned to receive~     treatment either in the office with the therapist or from another room (where communication~     will be over a computer). The research is designed to compare the effectiveness of treatment~     based on location.~      Tension headache sufferers will receive training in how to reduce their muscle tension~     levels. They will be randomly assigned to have equipment monitor muscle tension levels either~     in the forehead or shoulder regions. The research is designed to compare the effectiveness of~     feedback to the forehead versus the shoulder muscles.~   "
272935|NCT00018798|"~     The primary goals for this investigation are to quantify: (1) fluctuations in PTSD symptom~     reports when assessed at bi-weekly intervals; (2) change in PTSD symptoms associated with~     stressful life events; and (3) change in PTSD symptoms associated with perceived social~     support.~   "
272936|NCT00018785|"~     Diabetes and end-stage kidney, liver and heart disease are prominent health issues among~     veteran patients. Successful solid organ transplantation in the absence of chronic~     immunosuppressive therapy (specific acquired immunological tolerance) is a desirable~     therapeutic option. This project extends recent observations supporting the use of~     concommitant donor bone marrow cell infusion as a means of modulating the immune response in~     kidney transplantation, thereby allowing a substantial decrease or withdrawal of potentially~     toxic immunosuppressive drugs.~   "
272937|NCT00018772|"~     Deep venous thrombosis is the presence of blood clots, usually in the legs that lead to~     either local problems or breathing problems if the clot moves to the lungs. This study is~     designed to assess both clinical conditions as well as common genetic factors that lead to~     more risk of deep venous thrombosis. Clinical conditions of venous thrombosis include:~     stroke, malignancy, and situations such as surgery, pregnancy, trauma, or travel.~   "
272938|NCT00018759|"~     This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine,~     is associated with cellular calcium response to serotonin, platelet serotonin receptors, and~     improvement in mood in depressed patients with or without hypertension. It is hypothesized~     that platelets of hypertensive patients with depressive symptomatology with be~     hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is~     expected to produce a down-regulation of the serotonin receptor with an associated reduction~     in platelet cytosolic calcium response as well as improved mood.~   "
272939|NCT00018746|"~     The study examines efficacy of repetitive transcranial magnetic stimulation in treating~     severely depressed patients who are medicated.~   "
272940|NCT00018733|"~     This study will be measuring changes in depressive symptoms over a 7 week time period.~     Double-blind placebo controlled trial using the pharmacologic agents Paroxetine or~     Desipramine.~   "
272941|NCT00018720|"~     The purpose of this study is to determine how people with high triglycerides metabolize and~     absorb bile acids, compounds made in the body from cholesterol.~      This project has two objectives: A) To define the mechanism of impaired bile acid absorption~     in hypertriglyceridemia (specifically we will determine if the active or passive component of~     absorption is abnormal) and B) to determine the contribution of an alternative pathway of~     bile acid synthesis which begins with 27-hydroxylation of cholesterol. Because 27-hydroxylase~     is present in endothelial cells as well as liver, this pathway may play a role in removal of~     cholesterol from incipient atherosclerotic plaque.~   "
272942|NCT00018707|"~     This is the follow-up to an observational epidemiological study of psychological and~     neuropsychological outcomes of deployed and non-deployed Gulf War-era veterans.~   "
272954|NCT00018551|"~     Colorectal neoplasia is the second most common cancer in the United States and other Western~     countries with about 140,000 newly diagnosed cases per year in the United States with a~     mortality rate of about 40%. The identification of a specific natural or synthetic compound~     with the ability to reverse or suppress the process of colon carcinogenesis would have~     profound implication in the development of colorectal adenomas and their subsequent~     transformation to colon cancer. Furthermore, the establishment of a correlative relationship~     between biomarkers of cell proliferation, differentiation, apoptosis and adenoma recurrence~     would provide pivotal data required to elucidate cell signaling mechanisms in future colon~     cancer chemoprevention trials.~   "
272955|NCT00018538|"~     Prostate cancer is a common occurrence in the aging population, with one in ten men destined~     to develop the disease. 40% of patients with prostate cancer experience a recurrence after~     definitive treatment. This study addresses the as-yet unresolved problem of the optimal~     management of early recurrence as manifested by increase in the accepted marker for this~     disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to~     inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and~     to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This~     study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses~     of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for~     developing an approach to this problem that will delay or prevent progression.~   "
272956|NCT00018525|"~     The main objectives of this study are to see if a type of lung surgery, known as lung~     reduction surgery, in addition to standard medical treatment improves the quality of life,~     lung function, and reduces the high mortality associated with severe emphysema when compared~     to standard medical treatment alone. Another goal of this study is to better identify the~     patients most likely to benefit from this surgical treatment. The information obtained in~     this study is important because lung reduction surgery is being done in several centers~     around the country but its long term benefits, if any, over standard medical treatment, are~     not known.~   "
272957|NCT00018512|"~     The primary term goal of these research efforts has been to enhance the functional status,~     comfort and quality of life of edentulous patients by evaluating clinical procedures, denture~     designs and adjunctive therapies based upon a clear understanding of: (1) oral functional~     impairments caused by the loss of teeth and subsequent tissue changes; (2) neurophysiological~     mechanisms associated with oral functions; (3) metabolism of oral tissues; and (4)~     interactions between biological and psychological processes and denture characteristics. The~     primary purpose of the proposed clinical outcome study is to compare the relative efficacies~     of three different combinations of implant-supported maxillary and mandibular prostheses with~     traditional complete dentures for edentulous patients. Completion of this study will~     determine the relative cost-effectiveness of the implant-supported denture treatments for use~     in the general population of edentulous patients.~   "
272958|NCT00018499|"~     Genetic differences in response to brain injury may reasonably be expected to play a role in~     the initial consequences of traumatic brain injury and in the rate of recovery from such~     injury.~   "
272959|NCT00018486|"~     The purpose of this study is to determine if individuals with diabetes are at increased risk~     of hearing impairment or tinnitus (the perception of ringing or noises in the ears or head).~     An important goal of this research is also to obtain a better understanding of possible~     interactions between hearing disorders and other chronic conditions, such as diabetes.~     Participation in this research will be for a few hours only, to be scheduled at the~     participant's convenience and according to the testing schedules of the different clinics~     involved.~   "
272960|NCT00018473|"~     This study will create Alzheimer 's disease risk profiles for defined combinations of~     genotypes and environmental exposures. This study will carry out a molecular epidemiologic~     study to identify genetic and environmental risks factors using state of the art techniques.~     The following will be done during the course of this study 1) Recruit both Alzheimer's~     patients and cognitively normal aged veterans. 2) Evaluate gene interaction in Alzheimer's~     disease. 3) Evaluate gene-environment interactions on the risk of Alzheimer's disease. These~     procedures should initially address the question as to whether certain genes either~     independently or synergistically modify the risk of Alzheimer's disease. This study will also~     determine whether certain environmental factors (smoking, alcohol consumption etc.) can~     modify the risk of AD and whether this effect is dependent on certain genetic backgrounds.~     This study will provide information that will be useful in designing therapies, develop risk~     factor profiles to be further tested in future studies, designating patients for specific~     therapies based on genetic factors and providing data and genetic material for future~     studies. This study will also provide a cohort of older and well characterized cognitively~     normal veterans for prospective genetic epidemiological studies on aging.~   "
272961|NCT00018460|"~     Determine whether low or high dose B vitamin therapy will lower homocysteine and~     thrombomodulin in patients anticoagulated with warfarin.~   "
272962|NCT00018447|"~     This study is designed to determine if combining parathyroid (PTH 1-34) with fluoride (MFPSR)~     therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of~     the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e.,~     decreased bone formation and no further increase in bone density) that is observed within~     18-24 months of PTH therapy; (3) eliminate the calcium deficiency and osteomalacia that can~     occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an~     increase in bone density which is maintained after treatment is discontinued.~   "
272963|NCT00018434|"~     Current projects study veteran patients with chronic ulcers and MRSA colonization and~     infection, patients with imipenem-resistant P. aeruginosa colonization and infection, the~     relationships between staffing pattern, severity of illness and nosocomial infections in~     intensive care units and infection control practices for veteran patients with suspected~     tuberculosis.~   "
272964|NCT00018421|"~     This randomized trial investigates the hypothesis that regular aerobic exercise training~     using a task specific gait training modality will improve cardiovascular fitness, functional~     mobility, and reduce risk factors for recurrent cardiovascular events in chronic hemiparetic~     stroke patients, when compared to matched controls performing just stretching.~   "
272965|NCT00018408|"~     The purpose of this study is to determine whether genetic factors contribute to an~     individuals risk of developing obstructive lung disease from smoking cigarettes.~   "
272972|NCT00018317|"~     This study will examine the effects of long-term adherence to a low protein diet (LPD) of 0.6~     g/kg-1/d-1 with and without progressive resistance exercise training in patients with~     impaired renal function on body composition, renal function (glomerular filtration rate),~     nitrogen balance, muscle strength and size, and functional capacity. The hypothesis is that~     adherence to a LPD will result in a reduction in skeletal muscle mass and reduced strength~     and functional capacity while those patients who adhere to the LPD and exercise will~     demonstrate a similar preservation of renal function but will have greater fat free mass,~     muscle mass and strength. The intervention trial will last 18 months in which patients with~     moderate renal failure will be randomly assigned to one of 4 interventions: standard care,~     standard care + exercise, LPD, and LPD with exercise. In this way the independent and~     combined effects of diet and exercise on the progression of renal disease and body~     composition will be monitored. This study will have important implications for the treatment~     of patients with chronic renal failure. New strategies of combining exercise with~     recommendations of a low protein diet may slow the progression of renal disease and improve~     strength and functional capacity in these at-risk patients.~   "
272973|NCT00018304|"~     The overall objective of this proposal is to examine the contribution of changes in total~     body fat, enhancement in insulin-mediated vasodilatation and enhancement in~     endothelium-derived nitric oxide production to the improvements in metabolic insulin action.~     In addition, the study will track whether these improvements are related to changes in blood~     pressure.~   "
272974|NCT00018291|"~     This study is aimed at investigating specific pharmacological interventions in the treatment~     of the disruptive, agitated behavior associated with Alzheimer's patients. In addition, it is~     hoped that specific clinical profiles will be found to predict which treatment is most~     effective for these particular patients.~   "
272975|NCT00018278|"~     The main purpose of this study is to determine the electrophysiological effects of~     cholinergic therapy (cholinesterase inhibitors and transdermal nicotine) in Alzheimer~     disease. The attempt will be to locate electrophysiological markers and predictors of~     cognitive and clinical treatment response.~   "
272976|NCT00018265|"~     The purpose of this study is to examine the impact of aerobic fitness on the ability of able~     and disabled older adults to perform daily functional activities. Subjects are tested in~     their oxygen use patterns as they perform a series of functional tasks (such as walking on~     stairs) and following a 24-week training program focused on improving the ability to perform~     daily tasks likely requiring aerobic fitness (such as walking on stairs).~   "
272977|NCT00018252|"~     Coronary artery disease (CAD) remains the leading cause of death in the elderly. Silent~     myocardial ischemia (SI) is a manifestation of CAD in which there is a transient alteration~     in myocardial perfusion, function, and/or electrical activity not accompanied by chest pain.~     Mental and emotional stress, in particular hostility and anger are potent inducers of SI,~     Individuals with SI are at a 3-5 fold higher risk for the development of angina, myocardial~     infarction and death than subjects without SI.~   "
272978|NCT00018239|"~     This study will determine whether the metabolic and cellular mechanisms contributing to~     improved insulin action after aerobic or resistive exercise are different in older, obese,~     insulin resistant veterans. The hypothesis is that regular exercise, whether aerobic or~     resistive, will improve whole body insulin action, but the nature and magnitude of changes in~     skeletal muscle will differ between the two types of exercise.~   "
272979|NCT00018226|"~     The purpose of this project is to assess whether enhanced outreach counseling (EOC) is an~     effective outreach strategy for discharged methadone maintenance patients compared to a~     standard referral procedure. EOC is a brief (30 minute) face-to-face intervention, followed~     by six weeks of ongoing telephone counseling/case management designed to help eligible~     out-of-treatment methadone patients re-enter treatment. Several studies have shown those~     patients who voluntarily re-enter treatment improve significantly following re-enrollment.~   "
272980|NCT00018213|"~     The aim of this study is to investigate the effects of naltrexone, alone and combined with~     nicotine patch, on responses of smokers to smoking cues after 10 hours of tobacco~     deprivation. Smokers who are not seeking treatment will be assigned to one of six conditions:~     They will receive either 50 mg of naltrexone or a placebo pill, and also will wear a nicotine~     patch that has 0, 21, or 42 mg of nicotine during the tobacco deprivation period. Both the~     day before the medication and deprivation and at the end of 10 hours of deprivation all will~     be exposed to lit cigarette cues in the laboratory. Effects of the medications will be~     assessed on withdrawal measures, urge to smoke, psychophysiological measures, and the~     topography of smoking three test cigarettes. Studies such as these can help to identify~     potential interventions for tobacco cessation or withdrawal, and thereby could result in less~     suffering and mortality.~   "
272981|NCT00018200|"~     The purpose of this study is to determine whether different types of antidepressant medicines~     relieve back pain that has lasted at least six months on a daily basis. Study participants~     will be assigned to treatment with either a antidepressant acting on the serotonin system in~     the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control~     medication not expected to relieve pain (benztropine). Each participant will be seen at least~     nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.~   "
272982|NCT00018187|"~     The purpose of this study is to test the effectiveness of a combination of the drugs~     bupropion and mecamylamine along with a nicotine patch as a therapy for smoking cessation.~   "
272983|NCT00018174|"~     This project is a treatment-matching study to test whether adding antidepressant~     pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's~     ability to quit, while not undermining cessation goals for the smoker who lacks a history of~     depression. The study target is to randomize 120 smokers with a prior history of depression~     and 120 smokers who lack such a history to a double-blind treatment with either 60 mg~     fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.~   "
272984|NCT00018161|"~     This protocol evaluates the efficacy of combining pharmacologic treatments for smoking~     cessation, entailing the use of the nicotine skin patch with the nicotinic antagonist~     mecamylamine, with a specific behavioral therapy designed to inhibit the smoking urge.~   "
273943|NCT00005329|"~     To test the hypothesis that low levels of free protein S, a natural anticoagulant protein in~     plasma, were associated with an increased incidence of myocardial infarction in middle aged~     men and women.~   "
272986|NCT00018135|"~     Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the~     blood and a secondary increase in the iPTH level. This chronic elevation in iPTH can have~     adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease~     the absorption of phosphorus present in the normal diet. Some preliminary studies have~     indicated that the iPTH level may change based on the amount of phosphorus present in a meal~     prior to any significant absorption of phosphorus. If this is true in hemodialysis patients,~     then the timing of the administration of phosphate binders in relation to the ingestion of~     meals needs to be considered~   "
272987|NCT00018122|"~     This grant is to study patients that have received a kidney transplant AND an Islet Cell~     transplant and to discover how the transplant is functioning. We will seek to have several~     patients who have had a kidney transplant but do NOT have either type of diabetes. These~     patients will serve as the control group since they will also be on immunosuppressive~     medications but are not affected by abnormal blood sugars. This will allow investigators to~     develop an understanding of how these immunosuppressive medications affect glucose metabolism~     (blood sugar levels) and insulin utilization (how the body uses insulin).~   "
272988|NCT00018109|"~     To establish a collaborative group of clinical trial centers, with standardized equipment and~     protocols, able to conduct both drug and gene therapy trials in DMD. To evaluate the~     therapeutic effect of glutamine and creatine monohydrate on muscle strength in children with~     DMD. To validate the use of QMT (quantitative muscle strength testing) and gait analysis in~     children with DMD as reliable tools to quantify muscle strength, monitor disease progression~     and assess therapeutic response.~   "
272989|NCT00018096|"~     In this project, we hypothesize that polymorphisms of genes expressed by the airway epithelia~     in asthmatics following specific airway challenges predispose individuals to the development~     of asthma. To test this hypothesis, we identify the genes that are differentially expressed~     by airway epithelial cells following challenge with stimuli that induce acquired (house dust~     mite) or innate (LPS) immune responses, and then determine whether polymorphisms in these~     genes are associated with the development of asthma in a separate, well characterized,~     familial cohort of asthmatics. This is a powerful approach that is designed to identify novel~     genes that are associated with both asthma pathogenesis (differentially expressed in the~     exposure-response study) and asthma susceptibility (genetically associated with asthma in a~     linkage/association study).~   "
272990|NCT00018083|"~     The primary objective of this multi-center sub-study of USPHS Study 23: Intensive~     Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid with Daily Efavirenz in~     Combination with Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-infections,~     is to compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with~     efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without~     efavirenz. Secondary objectives are: (1) To describe pharmacokinetics of both rifabutin and~     efavirenz in combination regimen, (2) To evaluate the safety of concomitant efavirenz and~     rifabutin, (3) To assess the effect on absolute neutrophil count by changing rifabutin dose~     and adding efavirenz to the regimen, (4) To develop models of optimal sampling times for~     rifabutin dosed twice a week, (5) To describe the pharmacokinetics of isoniazid in~     combination with efavirenz daily with two NRTIs, (6) To compare the pharmacokinetics of~     isoniazid with and without efavirenz.~   "
272991|NCT00018070|"~     This study will try to identify and treat feeder vessels in age-related macular degeneration.~     The macula is the part of the retina in the back of the eye that determines central or best~     vision. In macular degeneration, leaking blood vessels under the macula lead to loss of~     central vision. These vessels branch out tree-like from one or more feeder vessels. Instead~     of treating all the abnormal branching vessels, this study will try to find and close only~     the feeder vessels, thereby depriving the abnormal vessels of nutrition. The vessels will be~     closed with laser beam treatment.~      People 50 years of age and older with macular degeneration and visual acuity worse than 20/50~     in the study eye and the same or better vision in the other eye may be eligible for this~     study. Candidates will undergo fluorescein angiography to try to locate feeder vessels. For~     this procedure, a yellow dye is injected into an arm vein. The dye travels to the blood~     vessels in the eyes, and pictures of the retina are taken using a camera that flashes a blue~     light into the eye. The pictures show if any dye has leaked from the vessels into the retina,~     indicating possible blood vessel abnormality.~      Before laser treatment, participants will have a complete eye examination, including~     measurement of visual acuity, evaluation of the front part of the eye with a slit lamp~     microscope, examination of the retina with an ophthalmoscope, and measurement of eye pressure~     using a tonometer.~      During the laser treatment phase of the study, participants will have indocyanine green~     angiography-a procedure similar to fluorescein angiography, but using a green dye-to~     photograph the retina and identify feeder vessels. If feeder vessels are located, laser beam~     treatment will begin. For this procedure, the eye is anesthetized with numbing drops. A~     special contact lens is then placed on the eye for the laser treatment. The number of~     treatments depends on how well the individual patient responds, but usually between two and~     eight treatments are required.~      The indocyanine green angiogram will be repeated after the laser beam treatment to determine~     if the feeder vessels have been successfully closed. If the vessels remain partially open, a~     repeat application will be done, followed by another indocyanine green angiogram to check the~     results.~      Patients will be checked in the clinic after 1 week to see if additional treatment is needed.~     If so, re-treatment will be done in a week. If no re-treatment is required, follow-up visits~     will be scheduled 2, 3, and 6 weeks after treatment, 3 and 6 months after treatment, and~     every 6 months after that for 2 years to evaluate treatment results. The evaluations will~     include fluorescein angiograms and other examinations that were done before starting~     treatment. If abnormal vessels are still present or growing, repeat treatments will be~     applied following the same procedure.~   "
272992|NCT00018057|"~     This study uses functional magnetic resonance imaging (fMRI) to learn how the brain functions~     in adolescents receiving fluoxetine (Prozac) cognitive behavioral therapy (CBT) or~     interpersonal therapy (IPT) for anxiety or depression in children/adolescents.~      All participants will receive interviews to assess how they are doing in general, including~     general mood, degree of nervousness and behavior. Each participant and one of his or her~     parents will be interviewed separately and together. Those electing the medication study will~     also receive a physical examination. Participants are asked to complete tasks involving~     problem-solving and memory that involve looking at pictures, remembering things, testing~     reaction times, and making simple choices.~      Participants with anxiety or depression will first meet with a psychiatrist or psychologist~     for two weekly sessions of talk therapy.~      Those who remain anxious or depressed after these 2 weeks will have the 3 options based on~     their choice: 1) treatment with fluoxetine daily for 8 weeks 2) cognitive-behavioral therapy~     or interpersonal therapy (two kinds of talk therapy) once a week for 8 weeks 3) a random~     assignment (50% chance) to either placebo or fluoxetine for 8 weeks. In addition, subjects~     also will be randomly and blindly assigned to receive either an active computer-based~     training task or an inactive computer-based training task, administered as part of the~     other,along with their medication or talk -therapy treatment. The active training is thought~     to help anxiety whereas the inactive training is thought to have no effect. The purpose of~     this part of the study is to understand the best way to help children and adolescents who are~     having problems with anxiety. However, more research is needed to find the best way to help~     such children and adolescents. During and after the 8 weeks of treatment, each participant~     will complete verbal and written symptom ratings. Blood samples will be drawn for laboratory~     tests before drug treatment and after it ends.~      Those who have not improved by the end of the study will be offered other treatment for 1 to~     3 months, and the clinicians will help with finding subsequent aftercare. Those who improve~     with treatment will continue therapy at NIH until an outside physician is able to assume~     responsibility for monitoring medication.~      FOR MORE INFORMATION REGARDING THIS STUDY CALL THE CORE PHONE NUMBER: 301-496-5645~   "
273065|NCT00015067|"~     The purpose of this study is to attempt to identify possible dangerous interactions between~     cocaine and methylphenidate (MPD). Additional objectives are to determine: a) if MPD reduces~     the craving and high for cocaine; b) if there are pharmacokinetic and pharmacodynamic~     interactions between cocaine and MPD; and c) the relationship between cocaine and~     benzoylecgonine (BE) levels in plasma and BE levels in urine.~   "
272993|NCT00018044|"~     This study will examine the symptoms, course of disease and treatment of non-tuberculous~     mycobacterial (NTM) infections, as well as the genetics involved in these infections.~     Patients with NTM have recurrent lung infections and sometimes infections of the skin and~     other organs as well. They may also have curvature of the spine, barrel chest, and heart~     valve weakness. The study will compare the features of NTM with those of Job syndrome and~     cystic fibrosis, other diseases involving recurrent infections of the lungs and possibly~     other organs.~      Patients with diagnosed or suspected non-tuberculous mycobacterial infection, cystic fibrosis~     or Job syndrome may be eligible for this study. All participants will have a medical and~     family history, blood and urine tests, imaging studies that may include X-rays, computed~     tomography (CT) or magnetic resonance imaging (MRI) scans, and DNA and other genetic studies.~     In addition, all patients with Job syndrome and cystic fibrosis, and patients with NTM who~     have lung disease undergo the following procedures:~        -  Scoliosis survey X-rays of the spine to look for curvature or other abnormalities of the~          spinal column~        -  Echocardiography imaging test that uses sound waves to examine the heart chambers and~          valves~        -  Electrocardiogram measurement of the electrical activity of the heart~        -  Pulmonary function tests breathing tests to measure how much air the patient can move~          into and out of the lungs~        -  Body measurements measurements of height, weight, arm span, finger length, etc.~        -  Joint function assessment of joint mobility using different maneuvers to test~          flexibility of joints and ligaments~        -  Examination of physical features that might be associated with NTM, such as high arched~          palate of the mouth, flat feet, or certain skin features~        -  Dermatology (skin) examination for reactive skin conditions or other skin problems and~          possibly a skin biopsy (surgical removal of a small skin tissue sample for microscopic~          examination)~        -  Interview with genetics specialist~      These tests may require several days to complete. Patients with NTM will also be examined by~     a cystic fibrosis specialist and may have a sweat test. In addition, NTM patients will be~     asked to return to NIH every year for 5 years for follow-up tests, if medically indicated,~     including CT of the chest, scoliosis survey and examination by other specialists.~   "
272994|NCT00018031|"~     This study will evaluate the safety and effectiveness of combination therapy with~     peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in~     HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus~     ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is~     a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b.~     This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher~     blood concentration and thus maintaining activity against the hepatitis C virus.~      HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a~     viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates~     will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is~     not available. The liver biopsy is done to determine the severity of liver disease. For this~     test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is~     injected into an arm vein, the skin in the area over the biopsy site is numbed with a local~     anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small~     tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray,~     electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening~     tests, candidates who appear eligible for the study will have a physical examination, medical~     history and repeat blood tests. Women who can become pregnant will have serial pregnancy~     tests throughout the study.~      Patients who meet the study criteria and decide to participate will begin treatment with~     weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a~     day by mouth. In addition, patients will continue to take all other medications prescribed by~     their doctor. Clinic visits will be scheduled as follows:~        -  Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood~          levels of HIV and HCV.~        -  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests~          will be done to determine the side effects of treatment and its effect on the HCV~          infection.~        -  Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or~          earlier for those who do not complete the 48 weeks, patients will return to the clinic~          for a routine test.~   "
272995|NCT00018018|"~     This study will evaluate a new method for delivering gene transfer therapy to patients with~     severe combined immunodeficiency disease (SCID) due to a defective adenosine deaminase (ADA)~     gene. This gene codes for the adenosine deaminase enzyme, which is essential for the proper~     growth and function of infection-fighting white blood cells called T and B lymphocytes.~     Patients who lack this enzyme are vulnerable to frequent and severe infections.~      Some patients with this disease receive enzyme replacement therapy with weekly injections of~     the drug PEG-ADA (ADAGEN). This drug may increase the number of immune cells and reduce~     infections, but it is not a cure. Gene transfer therapy, in which a normal ADA gene is~     inserted into the patient s cells, attempts to correct the underlying cause of disease. This~     therapy has been tried in a small number of patients with varying degrees of success. In this~     study, the gene will be inserted into the patient s stem cells (cells produced by the bone~     marrow that mature into the different blood components white cells, red cells and platelets).~      Patients with ADA deficiency and SCID who are taking PEG-ADA and are not candidates for~     HLA-identical sibling donor bone marrow transplantation may be eligible for this study.~      Participants will be admitted to the NIH Clinical Center for 2 to 3 days. Stem cells will be~     collected either from cord blood (in newborn patients) or from the bone marrow. The bone~     marrow procedure is done under light sedation or general anesthesia. It involves drawing a~     small amount of marrow through a needle inserted into the hip bone. The stem cells in the~     marrow will be grown in the laboratory and a normal human ADA gene will be transferred into~     them through a special type of disabled mouse virus. A few days later, the patient will~     receive the ADA-corrected cells through an infusion in the vein that will last from 10~     minutes to 2 hours.~      Patients will be evaluated periodically for immune function with blood tests, skin tests, and~     reactions to tetanus, diphtheria, H. influenza B and S. pneumoniae vaccinations. The survival~     of ADA-corrected cells will be monitored through blood tests. The number and amount of blood~     tests will depend on the patient s age, weight and health, but is expected that blood will~     not be drawn more than twice a month. Patients will also undergo bone marrow biopsy aspirate~     (as described above) twice a year. Patients will be followed once a year indefinitely to~     evaluate the long-term effects of therapy.~   "
272996|NCT00018005|"~     This study will test whether a self-management (SM) intervention, compared to usual care,~     will reduce the risk for adverse clinical outcome in patients with mild to moderate heart~     failure.~   "
272997|NCT00017979|"~     This study will use transcranial magnetic stimulation to examine how the brain controls~     movement by sending messages to the spinal cord and muscles and what goes wrong with this~     process in disease. Normal healthy volunteers between the ages of 18 and 65 years may be~     eligible to participate.~      In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp~     or skin. Brief electrical currents are passed through the coil, creating magnetic pulses that~     stimulate the brain. During the stimulation, participants will be asked to tense certain~     muscles slightly or perform other simple actions. The electrical activity of the muscle will~     be recorded on a computer through electrodes applied to the skin over the muscle. In most~     cases, the study will last less than 3 hours.~   "
272998|NCT00017966|"~     This study will use transcranial magnetic stimulation to examine how the brain controls~     movement by sending messages to the spinal cord and muscles and what goes wrong with this~     process in disease. Normal healthy volunteers 18 years of age and older may be eligible to~     participate.~      In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp~     or skin. Brief electrical currents are passed through the coil, creating magnetic pulses that~     stimulate the brain. During the stimulation, participants will be asked to tense certain~     muscles slightly or perform other simple actions. The electrical activity of the muscle will~     be recorded on a computer through electrodes applied to the skin over the muscle. In most~     cases, the study will last less than 3 hours.~   "
272999|NCT00017940|"~     This Phase I clinical trial is the first step in testing gene therapy. This study is called a~     Safety/Toxicity study by the Food and Drug Administration, and primarily aims to determine~     whether the experimental protocol is safe for humans. It will determine whether the study~     procedure causes side effects in humans, and may also give us a preliminary sense of whether~     this will be effective in combating Alzheimer's disease in humans.~   "
273148|NCT00013130|"~     Health care organizations, including the VA, are investing substantial effort to improve~     quality of care. As part of this process, greater emphasis is being placed on measurement of~     outcomes, and in particular, functional outcomes and satisfaction as reported by patients.~   "
273001|NCT00017927|"~     This study will examine the effect of pegvisomant on growth hormone excess in patients with~     McCune-Albright syndrome (MAS). Patients with this disease have polyostotic fibrous~     dysplasia-a condition in which areas of normal bone are replaced with fibrous growth similar~     to scar tissue, abnormal skin pigmentation (birth marks) and precocious (early) puberty.~     About 10 percent of patients have excess growth hormone (GH). GH stimulates the production of~     another hormone called insulin-like growth factor 1 (IGF-1). Together, GH and IGF-1 affect~     bone growth. The excess of these hormones in MAS can cause overgrowth of the bones of the~     face, hands and feet, excess sweating, or increased height.~      Pegvisomant is a synthetic drug that binds to cell receptors where GH would normally bind,~     thus preventing the naturally occurring hormone from stimulating IGF-1 and bone growth as it~     normally would. This study will see if pegvisomant will reduce blood levels of IGF-1 and~     mitigate the effects of growth hormone excess, including bone pain, bone turnover, hand and~     foot swelling and sweating, and abnormal levels of related hormones.~      Patients who were screened for polyostotic fibrous dysplasia and MAS under NIH protocol~     98-D-0145 and were found to have MAS with excess growth hormone are eligible for this 36-week~     study. The screening protocol includes a history and physical examination, blood and urine~     tests, hearing, eye and dental examinations, pain and physical function evaluations,~     endocrine and bone screening tests, various bone imaging studies, including magnetic~     resonance imaging (MRI) and computed tomography (CT) scans and bone biopsy in patients over 6~     years old.~      Participants in the current study will receive daily injections of either pegvisomant or~     placebo (an inactive substance) for 12 weeks, followed by a 6-week washout period with no~     drug. Then, patients who received placebo will be switched, or crossed over, to receive~     pegvisomant for another 12 weeks, and those who received pegvisomant will receive placebo.~     This will be followed by another 6-week washout period. The drug and placebo will be injected~     under the skin, similar to insulin injections. Blood and urine tests will be done at the~     beginning of the study and repeated every 6 weeks until the study ends.~   "
273002|NCT00017914|"~     This study will evaluate subjects with adult- and childhood-onset myositis to learn more~     about their cause and the immune system changes and medical problems associated with them.~     Myositis is an inflammatory muscle disease that can damage muscles and other organs,~     resulting in significant disability.~      Children or adults with polymyositis or dermatomyositis or a related condition may be~     evaluated under this study. Healthy children or adults will also be enrolled as controls,~     for comparison of test results.~      All patients will undergo a complete history (including completing some questionnaires) and~     physical examination, review of medical records, and blood and urine tests. Patients may then~     choose to participate in an additional 1- to 5-day evaluation, which will include some or all~     of the following diagnostic, treatment or research procedures:~        1. Standardized muscle strength testing, range of motion of joints and walking (gait)~          analysis by a physiotherapist; completion of a questionnaire regarding ability to~          perform daily tasks~        2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of~          a small skin sample under local anesthetic)~        3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg~          muscles~        4. Swallowing studies, including a physical examination and questionnaire on swallowing~          ability, studies of tongue strength, and ultrasound imaging during swallowing, and~          possibly, a modified barium swallow~        5. Voice and speech assessment, possibly including computerized voice analysis and~          laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera~          placed in the mouth to view and record vocal cord function~        6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a~          breathing machine) to evaluate lung function and, possibly, chest X-ray~        7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly,~          echocardiogram (ultrasound imaging of the heart)~        8. Endocrine evaluation~        9. Eye examination, in patients with vision loss or other eye symptoms~       10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape~          measurements or bioelectric impedance testing, a painless procedure in which wires are~          attached to the extremities with a sticky paste.~       11. Muscle ultrasound.~       12. Electromyography (record of the electrical activity of muscles)~       13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic~          examination)~      All patients may have only a one-time evaluation or may return for one follow-up evaluations~     (either the 1-day or 3- to 5-day evaluation) over a 1-year period.~      Healthy children will undergo a medical history and brief physical examination; blood and~     urine tests; speech and swallowing studies including questionnaires and physical examination,~     tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18~     years old may also have exercise testing.~   "
273003|NCT00017875|"~     This study will use transcranial magnetic stimulation to examine how the brain controls~     muscle movement in focal and generalized types of dystonia. Dystonia is a movement disorder~     in which involuntary muscle contractions cause uncontrolled twisting or abnormal postures.~     Dystonia may be focal, involving just one region of the body, such as the hand, neck or face.~     Focal dystonia usually begins in adulthood. Generalized dystonia, on the other hand,~     generally begins in childhood or adolescence. Symptoms begin in one area and then become more~     widespread.~      Healthy normal volunteers and patients with focal or generalized dystonia 8 years of age and~     older may be eligible for this study. First-degree relatives of patients will also be~     enrolled.~      In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp~     and brief electrical currents are passed through the coil, creating magnetic pulses that pass~     into the brain. These pulses generate very small electrical currents in the cortex-the outer~     part of the brain-briefly disrupting the function of the brain cells in the stimulated area.~     The stimulation may cause muscle twitching or tingling in the scalp, face and limbs. During~     the stimulation, the subject will be asked to either keep the hand relaxed or to slightly~     tense certain muscles in the hand or arm. The test will last about 1.5 hours.~      The cause of dystonia is unknown. It is hoped that a comparison of brain activity in normal~     volunteers, patients and their relatives not affected by dystonia will help scientists learn~     why some people develop dystonic movements.~   "
273004|NCT00017836|"~     To examine the role of depression on risk for cardiovascular disease in twins.~   "
273005|NCT00017823|"~     The purpose of this study is to see whether acupressure (acupuncture using pressure applied~     by the hands instead of needles) can help nausea and vomiting in persons with HIV/AIDS.~   "
273006|NCT00017810|"~     The purpose of this study is to see whether changes in diet and behavior lessen the number of~     times HIV-positive people get diarrhea (soft or loose stools).~   "
273007|NCT00017745|"~     The Neuromuscular Diseases Section (NDS) is conducting research on certain inherited~     myopathies and neuropathies, disorders that lead to disability and sometimes death. NDS,~     along with other groups, has identified some disease-causing genes. The National Institutes~     of Health Clinical Center proposes new research to identify additional hereditary~     neuromuscular diseases and conduct genetic studies in order to localize, clone, and~     characterize the diseases.~      An expected 50 patients with known or suspected inherited myopathy or neuropathy and their~     families will be recruited for this study. If travel to the Clinical Center is impossible,~     investigators may come to them to do the tests. Ten to twenty cubic centimeters of blood will~     be drawn for DNA extraction and genotyping. Some abnormal movements of muscle atrophy will be~     documented by videotaping. If necessary, diagnostic laboratory and radiographic studies will~     be done to confirm diagnosis. Because the diseases are hereditary, blood may also be drawn~     from family members. The family will be counseled and the participants invited back annually~     to investigate the progression of the disease.~      Each participant will be evaluated by a history and initial neurological exam. Up to another~     20 mL of blood will be drawn for routine blood studies. Other medical care procedures may~     include a chest x-ray, EKG and echocardiogram, CT (computed tomography) or MRI (magnetic~     resonance imaging) scan, pulmonary function tests, and physical therapy assessment. Possible~     research procedures may include MR spectroscopy, nerve conduction study, electromyography,~     muscle or nerve biopsy, and lumbar puncture.~      The researchers have decided not to inform the family if nonpaternity or adoption is~     discovered by the DNA genotyping. Also, because a carrier of the disease gene may not~     necessarily develop the disease, family members will not be informed if they are carriers.~   "
273066|NCT00015054|"~     The purpose of this study is to demonstrate the feasibility of methylphenidate (MPD) as~     effective and safe in the outpatient treatment of cocaine-dependent patients with a comorbid~     DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), to demonstrate the~     ability of each site to participate in a subsequent anticipated controlled trial of MPD~     (recruitment and execution), and to gather preliminary data on the ability of sweat patches~     to detect episodes of cocaine use.~   "
273008|NCT00017732|"~     RSH/Smith-Lemli-Opitz syndrome (SLOS) is one that causes mental retardation. It is common in~     the Caucasian population but rare in African American and African black populations. It has~     been shown that SLOS is caused by a specific defect in DHCR7, an enzyme used in cholesterol~     metabolism. Studies have already been done to determine the frequency of the SLOS-causing~     mutations in various geographic Caucasian populations. This study will investigate the~     frequency of the DHCR7 mutations in the African American population. If the frequency~     observed suggests that SLOS cases are not being identified in this ethnic group, the study~     will provide the rationale for future studies to identify these patients.~      The sample size will be 1,600. The study population will consist of archived biological~     specimens in the form of newborn screening blood spots from two newborn screening centers,~     one in Maryland and one in Pennsylvania. Subjects will be of African American ethnicity,~     including blacks of African, Caribbean, and Central American descent.~      Genomic DNA will be extracted from blood spots and screened for the six common SLOS~     mutations. If SLOS syndrome is found, followup will be attempted for the Maryland samples~     (the Pennsylvania samples will be totally anonymous).~   "
273009|NCT00017706|"~     This randomized clinical trial will determine the efficacy of physicians providing weight~     control advice to their overweight and obese patients in primary care practice.~   "
273010|NCT00016848|"~     This study will try to determine if intake of dietary fats or carbohydrates influences the~     tendency to gain weight or accumulate body fat. It will examine how the hormones that~     regulate weight may change with a shift from a balanced diet to one that is low in fat or~     carbohydrate, irrespective of caloric intake.~      Men and women between the ages of 18 and 40 years with a body mass index of 30 to 49 kg/m2~     may be eligible for this study. Candidates will be screened with a history, physical~     examination, blood tests and questionnaires regarding activity, prior diets, and eating~     patterns.~      Participants will follow two separate diet regimens for 5 days each. The first will be a~     balanced diet, and the second will be either a low-fat/high-carbohydrate diet or a~     low-carbohydrate/high-fat diet. The diets are not designed to produce weight loss.~     Participants will receive all their meals and snacks for the two diets from the National~     Institutes of Health and, for the first 3 days of each diet, will be seen as outpatients. For~     days 4 and 5 of each diet, they will be admitted to the Clinical Center and will undergo the~     following procedures:~        -  Blood tests - Blood samples will be collected every 30 minutes over a 24-hour period~          through an indwelling catheter in the arm. A total of about 15 tablespoons will be drawn~          for each of the two diets.~        -  24-hour urine collection - One 24 hour urine collection will be done at home the day~          before admission to the Clinical Center, and the other will be done during the hospital~          stay.~        -  Urinalysis and pregnancy test - A small urine sample will be taken and women will~          provide an additional sample for a pregnancy test.~        -  Body measurements - Height and weight will be measured using scales. Body fat will be~          measured by two methods: skin fold thickness, measured with calipers in 5 separate~          places; and body circumference measurements, in which body parts are measured with a~          tape measure.~        -  Bod pod measurement - Proportions of fat and non-fat tissue in body weight are measured~          while the participant sits in a capsule-like device for 5 minutes.~        -  Bioelectric impedance analysis - Proportions of body fat are measured based on~          conduction of a small electric current.~        -  Total body water estimate -The proportion of body weight that is water is determined,~          using a method that involves drinking a cup of a special kind of heavy water~          (deuterium) and then measuring the amount of heavy water in a urine sample taken after 4~          hours.~        -  Exercise - Participants will maintain their usual exercise routine, as it was before~          beginning the study.~   "
273011|NCT00016835|"~     The purpose of this project is to obtain important preliminary data necessary to support~     design of a full scale, multicenter randomized clinical trial (RCT) to evaluate the effect of~     treating periodontal infection on glycemic control in type 2 diabetes mellitus.~   "
273012|NCT00017680|"~     OBJECTIVES: I. Determine the response, disease-free survival, and overall survival of~     patients with primary light chain amyloidosis treated with high-dose melphalan and autologous~     stem cell transplantation.~      II. Determine the toxicity of this regimen in these patients.~   "
273013|NCT00017654|"~     OBJECTIVES:~      I. Determine the effect of supplementation with donor T-cell depleted, CD34+ peripheral blood~     stem cells on durable engraftment and incidence of graft-versus-host disease in patients with~     aplastic anemia undergoing allogeneic bone marrow transplantation.~   "
273014|NCT00017641|"~     OBJECTIVES:~      I. Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte~     globulin followed by peripheral blood stem cell support in patients with systemic lupus~     erythematosus.~   "
273015|NCT00017628|"~     OBJECTIVES:~      I. Determine the efficacy, in terms of disease progression, of high-dose cyclophosphamide and~     total body irradiation with T lymphocyte-depleted autologous peripheral blood stem cell or~     bone marrow rescue in patients with multiple sclerosis.~   "
273016|NCT00016796|"~     This study will determine baseline language skills in children 4 to 8 years old. The data~     will be used to design studies using functional magnetic resonance imaging (fMRI) to identify~     what areas of the brain in children are involved in understanding language. This information~     is important for children who require brain surgery to control seizures.~      Healthy normal volunteers between the ages of 4 and 8 years who have an IQ of 70 or more; who~     have no history of neurologic, psychiatric or language disorder; who are performing at or~     above grade level, and who are native English speakers may be eligible for this study.~      Participants will be asked to do the following:~        -  name pictures or read words that appear on a computer screen~        -  listen to stories and answer questions about them~        -  match pictures to a spoken word~      The children's responses will be recorded.~   "
273017|NCT00016744|"~     We are testing a new combination of medicines, to determine if they could be used to treat~     cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation~     (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement~     in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this~     study to determine the safety of using a combination of two medicines, Phenylbutyrate and~     Genistein, to improve the ability of the cells lining the nose to regulate movement of salt~     (chloride) and water in people with CF.~      Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases~     (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose~     of this study. Genistein is a naturally occurring substance that is found in food products~     such as soy and tofu, but is also an investigational drug for this study. Both drugs may be~     able to restore normal chloride movements in body organs and glands. We will be studying salt~     and water in the nose movement by a technique called nasal transepithelial potential~     difference (NPD).~   "
273067|NCT00015041|"~     The purpose of this study is to evaluate the effect, pharmacokinetics and dose~     proportionality of buprenorphine when administered to non-dependent opiate users. 1) To~     evaluate whether plasma concentrations of buprenorphine increase proportionally to~     buprenorphine dose. 2) To evaluate the dose-response of subjective and physiological effects~     of buprenorphine; and 3) To determine the safety of buprenorphine.~   "
273018|NCT00016731|"~     The purpose of this study is to use brain imaging technology to compare how the brains of~     adolescents and adults are activated during tasks that involve emotional responses.~      Evidence suggests that adolescents and adults experience activation in similar brain regions~     when they engage in tasks that involve the processing of emotional stimuli. However, the~     degree of task-associated activation may differ between adolescents and adults. This study~     will use functional magnetic resonance imaging (fMRI) to compare brain activation patterns in~     adolescents and adults. This study will also be used to develop emotion-evoking fMRI tasks to~     determine whether there are puberty and age-linked components of brain development....~   "
273019|NCT00016679|"~     This study will determine the optimal dose of 1-octanol that will safely reduce tremors in~     patients with essential tremor-a disorder in which the hands, and sometimes the head, shake~     involuntarily. Current treatments may be ineffective or produce unwanted side effects.~     Ethanol (the chemical in beer and wine that causes intoxication) reduces tremor in many~     patients, but patients generally don't use it regularly because it interferes with daily~     activities. Laboratory studies show that 1-octanol, a drug that is similar to ethanol, may~     have the same beneficial effect on tremors with less likelihood of intoxication.~      Patients 21 years of age and older with essential tremor may be eligible for this 10-day~     study. Candidates will be evaluated with a neurological examination, blood tests, urinalysis~     and electrocardiogram (EKG). Those enrolled will be admitted to the hospital for 4 days for~     1-octanol administration and monitoring. On day 1, patients will have a medical history and~     physical examination. A catheter (a thin plastic tube) will be placed in a vein of the~     forearm for sampling blood. Patients will take one 1-octanol capsule (at one of seven doses)~     by mouth and will be monitored for tremors and drug side effects. Blood will be sampled~     periodically in the first 3 hours to determine 1-octanol blood levels. On days 2 and 3,~     patients will be monitored for additional side effects. On days 3 and 4, laboratory tests~     (blood and urine) will be done to evaluate liver and kidney function. On day 4, the catheter~     will be removed and the patient will be discharged from the hospital. A follow-up visit will~     be scheduled 1 week after discharge for a physical examination and blood, urine and EKG~     tests.~   "
273020|NCT00016666|"~     The purpose of this study is to determine what dose of a new timed-release tablet of the drug~     propranolol will reduce secretion of the hormone melatonin in healthy volunteers. This study~     will also determine whether suppressing melatonin will improve depressive symptoms in people~     with seasonal affective disorder (SAD).~      SAD (sometimes referred to as winter depression) is a condition in which people experience~     depression as a result of seasonal variations in light. Human brains have a circadian~     pacemaker that regulates many body functions. As the seasons change and light duration~     varies, the circadian pacemaker regulates seasonal behavior by transmitting a signal of day~     length to the pineal gland, which secretes the hormone melatonin. Melatonin secretion~     increases in the winter as the duration of light decreases. Evidence suggests that the~     melatonin signal of seasonal change is present in people with SAD but not in healthy~     volunteers; thus there is a possibility that seasonal changes which influence the duration of~     melatonin secretion control the course of illness in individuals with SAD. This study will~     determine whether propranolol can shorten the duration of melatonin secretion and mimic the~     effect of summer days to improve symptoms of depression in people with SAD.~      Healthy volunteers will be admitted to the hospital for about 2 days. The volunteers will~     receive either propranolol or placebo (an inactive pill) before going to bed and upon~     awakening. Blood samples will be collected at various times throughout the study.~      Participants with SAD will be interviewed periodically on an outpatient basis to determine~     the onset of depression in the fall or winter. Two weeks after depressive symptoms arise,~     participants will begin treatment with either propranolol or placebo. At the beginning of the~     treatment, participants will be hospitalized for about 2 days and will have blood collected~     at various times. During the hospital stay, participants will continue treatment with either~     propranolol or placebo in the morning and at night; all participants will receive propranolol~     at some point during the study. Participants will be interviewed weekly for 4 weeks.~      Premenopausal women with or without SAD will keep a record of their menstrual cycles and will~     use a urine test kit to identify the time of ovulation during the month before and after~     admission to the hospital.~   "
273021|NCT00016653|"~     This study will help to determine the effectiveness of glutamine and creatine as a possible~     therapy for DMD. Boys with DMD who are enrolled in this trial will be randomly chosen to~     receive creatine monohydrate or glutamine or an inactive placebo orally for six months. Once~     a month during the six-month treatment period, the study participants will have their muscle~     strength evaluated using manual and computerized testing methods. This study will be~     conducted at several CINRG Centers throughout the U.S., Belgium, Israel and Puerto Rico. This~     study is supported by the Muscular Dystrophy Association.~   "
273022|NCT00016627|"~     To map the gene (or genes) for familial pulmonary fibrosis.~   "
273023|NCT00016562|"~     This study will examine the origin and development of certain neurological diseases involving~     abnormal metabolism. A significant number of patients with progressive neurological disorders~     have not been diagnosed despite extensive workups. Lack of a specific diagnosis may amplify~     the distress of both the patient and family and decrease the chance of obtaining effective~     therapy. This study will try to advance the diagnosis and management of such patients.~      Patients with a metabolic neurological disease of unknown cause or one which presents an~     unusual or difficult management problem may be eligible for this study. This study does not~     include patients with known or suspected leukodystrophy.~      Participants will undergo various procedures, including physical and neurologic examinations,~     blood and urine tests, and magnetic resonance imaging (MRI) to determine the extent and~     severity of disease. MRI scanning uses a strong magnetic field and radio waves to show~     structural and chemical changes in the brain. During the procedure, the patient lies on a~     table in a narrow cylinder containing a magnetic field. He or she can speak with a staff~     member via an intercom system at all times during the procedure. Patients will also have a~     lumbar puncture (spinal tap) to examine the cerebrospinal fluid (CSF), which bathes the brain~     and spinal cord. To obtain the fluid, a local anesthetic is administered and a needle is~     inserted in the space between the bones in the lower back where the CSF circulates below the~     spinal cord. A small amount of fluid is collected through the needle. Although spinal fluid~     will not be examined regularly, this test may be requested during some clinic visits.~      X-rays, nuclear medicine scans and consultations may be obtained as needed. Other tests may~     include electroencephalograms (brain wave recordings), psychological tests, and speech and~     language and rehabilitation evaluations. A skin biopsy may be done to grow cells in culture~     for metabolic and genetic testing and to analyze the skin under a microscope. For the biopsy,~     an area of skin is numbed with an anesthetic and a small circular area is removed, using a~     sharp cookie cutter-type instrument.~      First degree relatives (parents, children or siblings) of patients with a metabolic disorder~     of unknown cause will be asked to provide a blood sample for DNA studies to try to identify~     genetic basis of the disorder.~      The study is expected to continue for 3 years, with yearly monitoring of patients for changes~     in neurological, ophthalmological and general medical status.~   "
273024|NCT00016549|"~     This study will evaluate the effectiveness of the drug bevacizumab, in combination with~     doxorubicin and docetaxel, in improving survival of patients with inflammatory breast cancer~     or locally advanced breast cancer. Inflammatory breast cancer is an aggressive form of~     locally advanced breast cancer that often causes a red, swollen, tender breast and is~     associated with a poor prognosis. Bevacizumab blocks the growth of new blood vessels that~     supply oxygen and nutrients to tumors, and therefore, may kill cancer cells or stop their~     growth. Doxorubicin and docetaxel are approved drugs for treating breast cancer.~      Patients 18 years of age or older with stage inflammatory breast cancer who have not been~     treated with chemotherapy or radiation therapy may be eligible for this study. Candidates are~     screened with a medical history and physical examination, blood and urine tests, chest x-ray,~     electrocardiogram, and MUGA scan or echocardiography (see below). A mammogram of both~     breasts, dynamic MRI imaging of the affected breast, computed tomography (CT) of the head,~     chest, abdomen and pelvis, and a bone scan are done to determine the extent of disease.~      Participants undergo the following procedures at various intervals before, during and/or~     after completing chemotherapy:~      Tumor and skin biopsies to study the effects of bevacizumab on tumor blood vessels, tumor~     growth, and the biology of inflammatory breast cancer. A small piece of tumor tissue and a~     small piece of skin from the affected breast are removed under local anesthesia for~     microscopic study.~      Dynamic MRI to examine changes in the blood vessels and breast cancer following bevacizumab~     treatment. This test involves injecting a contrast liquid into a vein before scanning. A~     standard MRI scan is done before the dynamic MRI.~      Blood tests are done to 1) study clot formation and breakdown, 2) measure levels of VEGF (a~     substance produced by breast cancer cells) and VCAM-1 (a substance produced by cells lining~     blood vessel walls), and 3) check blood counts and liver and kidney function.~      MUGA (a nuclear medicine scan that checks the heart's pumping ability) or echocardiogram~     (ultrasound scan of the heart to evaluate heart function.~      Blood pressure monitoring~      Urine tests~      CT scans and x-rays to evaluate disease before and after treatment.~      Patients will have a central venous line (plastic tube) placed into a major vein in the chest~     before beginning treatment. The line stays in the body during the entire treatment period and~     is used to give chemotherapy and other medications, if needed, and to draw blood samples. All~     treatment is given on a single day every 3 weeks. This constitutes one treatment cycle. Cycle~     1 consists of bevacizumab alone; cycles 2 through 7 consist of bevacizumab with doxorubicin~     and docetaxel. During each cycle, patients also receive injections under the skin of G-CSF, a~     drug that raises the number of infection-fighting white blood cells, which are often~     decreased as a side effect of chemotherapy. After cycle 7, patients may require surgery and~     radiation or radiation alone. After radiation treatment, bevacizumab is re-started, given~     alone every 3 weeks for an additional eight cycles. Patients whose tumors are positive for~     estrogen or progesterone receptors will be advised to take the drug tamoxifen or anastrozole~     for 5 years to decrease the chances of disease recurrence. This would begin with cycle 8.~   "
273025|NCT00016523|"~     This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for~     oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.~   "
273042|NCT00015600|"~     This community-based project, called the Together for Agricultural Safety project, was~     developed to help farmworkers reduce their exposure to dangerous agricultural chemicals (such~     as pesticides) through education and social marketing. The project is a partnership of~     university researchers and the Farmworkers Association of Florida. After collecting extensive~     data from farmworkers, health providers and farm owners about primary means of pesticide~     exposure we are collaboratively developing an intervention that will reduce pesticide~     exposure by educating workers and owners about: the need to have adequate washing facilities;~     to wash hands frequently; to obey reentry intervals; to change work clothes after work to~     prevent child exposure and more.~   "
273026|NCT00016510|"~     This study will examine differences in how the brain processes English and Korean in native~     Korean speakers who are fluent and non-fluent in English as a second language. It is thought~     that people who are non-fluent in a second language process the second language differently~     from their native language-using different areas of the brain and requiring additional~     working memory. The study will increase understanding of language acquisition, brain~     plasticity and bilingualism.~      Native Korean speakers between 18 and 50 years of age with English as a second language may~     be eligible for this study. Three groups of individuals will be enrolled: 1) less fluent~     bilinguals - those who have lived in the United States for at least 1, but less than 2 years~     and studied English after age 12 and who have a TOEFL (Test of English as a Foreign Language)~     score above 550; 2) fluent bilinguals with early acquisition - those who were exposed to~     English before age 7 and lived in the United States after that; and 3) fluent bilinguals with~     late acquisition - those who were exposed to English after age 12 and lived in the United~     States after age 10. People with a history of head injury or neurological or thought~     disorder, left-handed people, and people who cannot read the material used in the study will~     be excluded from the study.~      Participants will undergo magnetic resonance imaging (MRI) scanning while reading words in~     English or Korean; while translating from one language to the other; and while answering~     questions about the meaning of words in each language. MRI uses a strong magnetic field to~     image brain tissue. The patient lies on a table that slides into a narrow metal cylinder,~     which is the scanner. The head is restrained gently with foam padding to limit movement. The~     patient can see out of the scanner through a mirror and is in contact with the technician via~     an intercom at all times during the procedure. The scans measures blood flow to different~     parts of the brain, providing information about what brain regions are being used during the~     tasks performed. Another scan will be done to obtain a detailed picture of the brain's~     structure.~      This study will evaluate the usefulness of MRI in identifying brain areas involved in~     processing different languages and increase knowledge about how illness affects brain~     function. It may help plan treatment for bilingual patients who must undergo brain surgery~     for uncontrolled epilepsy or who have a neurological disorder affecting different languages~     with varying degrees.~   "
273027|NCT00016497|"~     The purpose of this study is to evaluate the efficacy of three different surgical treatments~     (1. Bilateral myringotomy and tube insertion (M&T); 2. Adenoidectomy and bilateral~     myringotomy (A&T); 3. Adenoidectomy with myringotomy and tympanostomy tube insertion (A-M&T))~     in reducing subsequent episodes of middle ear disease and hearing loss caused by the fluid in~     the middle ear in children aged 24-47 months. The fluid in the middle ear is of at least~     three months' duration and unresponsive to standardized, recent antimicrobial treatment. The~     children are assigned to one of the three surgical treatments. After surgery, they are~     followed with examinations monthly and at the time of intercurrent infections for three~     years.~   "
273028|NCT00016471|"~     Hearing loss and loss of vision can be very harmful to the well-being and life of people who~     suffer from them. Usher syndrome is the name of a disease where people have both hearing loss~     and visual loss. In fact more than half of people who are deaf and blind have Usher syndrome.~     In this study we are trying to find the causes of all types of Usher syndrome and to learn~     more about how the eyes and ears work. Usher syndrome is caused by changes in our genes that~     lead to mistakes in the functioning of our eyes and ears.~      We may conduct hearing tests called audiograms to test hearing and a vision test called an~     electroretinogram (ERG) to test how well the retina (the part of your eye that senses light)~     is working on participants in the study. From these tests we can tell what kind of Usher~     syndrome a participant may have.~      We will then get DNA from participants by drawing blood. The DNA will be studied, along with~     DNA from members of the participant's family and other families, to try to find the gene that~     is causing Usher syndrome in the participant.~      Once the gene is found we will be able to study it to learn more about how the eyes and ears~     work.~      If a subject has already been diagnosed we may just need copies of their medical records and~     blood can be drawn locally.~      In order to increase the power of the study and the likelihood of detecting relevant genes~     participants will be taken from the Ashkenazi Jewish population group only. This will make it~     much easier to find the genes.~   "
273029|NCT00016458|"~     OBJECTIVES: I. Determine the toxicity of cyclophosphamide and rabbit anti-thymocyte globulin~     in patients with diffuse systemic sclerosis.~      II. Determine the efficacy of this regimen in terms of controlling disease in these patients.~   "
273030|NCT00016445|"~     OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body~     weight, and lean body mass in patients with cystic fibrosis.~      II. Determine the effect of growth hormone on pulmonary function in these patients.~      III. Determine the impact of this drug on the quality of life in these patients.~      IV. Determine if the clinical response from this drug is sustained in these patients.~   "
273031|NCT00015808|"~     This study will determine the highest dose of idebonone that can safely be given to patients~     with Friedrich's ataxia, an inherited degenerative disease that causes loss of muscle~     coordination, speech problems, weakness and sensory loss. Enlargement of the left ventricle~     (the large pumping chamber of the heart) is also common in this disease. In studies in France~     and Canada, patients with Friedrich's ataxia who were given idebonone, an antioxidant similar~     to the dietary supplement coenzyme Q, had a decrease in the size of their left ventricle.~      Patients 5 years and older with Friedrich's ataxia may be eligible for this study. Pregnant~     and lactating women may not participate. Candidates will be screened with a medical history~     and physical examination and a review of genetic studies. Patients who have not had genetic~     studies will be offered genetic counseling and testing to confirm or rule out Friedrich's~     ataxia.~      Participants will be admitted to the NIH Clinical Center for 3 days. They will have blood and~     urine tests and a heart evaluation, including an echocardiogram-a procedure that uses sound~     waves to produce images of the heart, and an electrocardiogram-a study of the electrical~     activity of the heart. When these tests have been completed, patients will take an idebonone~     capsule. They will be monitored for side effects for 72 hours. Blood samples will be~     collected through an intravenous catheter (flexible plastic tube placed in a vein) 0.5, 1, 2,~     3, 4, 6, 12, 24, 48 and 72 hours after the drug is taken to determine how long it takes for~     the drug to be eliminated from the body.~      Patients will return for a follow-up visit within 1 to 8 weeks. Those who experienced no~     serious side effects may receive another, higher dose of the drug, with at least 6 days~     between doses.~   "
273043|NCT00015587|"~     This study is a case-control study investigating the causes of childhood leukemia in Northern~     California. The overall purpose of this epidemiologic study is to find specific genetic or~     environmental factors that may increase the risk of leukemia in children. The study is being~     conducted by Patricia Buffler, PhD at the School of Public Health - University of California~     Berkeley in collaboration with the California Department of Health Services and 16 hospitals~     located throughout the state of California. The study began in 1995 and will continue to~     2014.~   "
273068|NCT00015028|"~     The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone~     sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The~     developmental objective for this combination product is an expansion of therapeutic options~     for the treatment of opiate dependence.~   "
273032|NCT00015795|"~     This study will investigate and compare the air stream during voice production in patients~     with abductor spasmodic dysphonia and in normal volunteers. People with abductor spasmodic~     dysphonia have uncontrolled muscle spasms during speech, resulting in a weak voice. A better~     understanding of the abnormalities of this disorder may help in the development of more~     effective treatments.~      Healthy volunteers and patients with abductor spasmodic dysphonia may be eligible for this~     study. Candidates will have a physical examination and medical history. (Patients will be~     videotaped and voice-recorded during the medical interview for review by specialists who will~     identify the type and severity of their speech disorder.) All candidates will also undergo a~     procedure called flexible fiberoptic laryngoscopy to record the movement of the vocal folds~     during speech, breathing and other tasks such as singing, whistling and prolonging vowels.~     For this test, the inside of the nose is sprayed with an anesthetic (lidocaine) to numb the~     nasal cavity and a decongestant (oxymetazoline) to widen the nasal passage. Then, a thin~     flexible tube called a nasolaryngoscope is passed through the nose to the larynx (voice box).~     A camera attached to the eyepiece of the nasolaryngoscope records the movements of the vocal~     folds.~      Participants will then have an airway interruption test to detect pressure changes in the~     voice box during production of continuous sounds. A nose clip is placed over the subject's~     nose and two sensor devices are placed on the neck to pick up changes in movement and~     position of the vocal cords during voicing. A mouthpiece is placed in the mouth, and subjects~     are asked to say ah continuously at a specified sound level. This voicing is repeated 33~     times with periodic breaks.~      Patients only will also be given an injection of botulinum toxin. These injections are~     effective, in varying degrees, in about 60 percent of patients with abductor spasmodic~     dysphonia. This study will use a different approach to botulinum toxin injections to test~     their effect in patients with pressures higher than normal. Rather than inject the posterior~     cricoarytenoid muscle or the cricothyroid muscle, as is typically done, the thyroarytenoid~     muscle, which closes the voice box, will be injected on one side. A second one-sided~     injection may be given after 2 or 3 weeks if no effect is seen after the first injection.~     Speech will be recorded at each visit to measure any change in symptoms after the injection.~   "
273033|NCT00015782|"~     Mucolipidosis Type IV (ML-IV) is a metabolic disorder that causes mental and motor~     retardation as well as visual impairment. There is storage of material in practically all the~     cells of the body, causing problems in the brain and the eyes. The disease is caused by a~     defect in a gene that makes a protein called mucolipin. Patients with ML-IV do not make~     enough normal mucolipin.~      More than 80 patients have been diagnosed, most of whom are Ashkenazi Jews. The disease often~     appears in the first year of life as either delayed motor development or corneal clouding.~     There are conflicting reports concerning the progressive nature of the disease. Some patients~     have clear deterioration, while others seem to stay at the same level of the disease for a~     long time. This study may lead to a better understanding of the disease, the medical~     difficulties of patients, and better ways of diagnosing ML-IV.~      Patients with a definite diagnosis of this disease, as well as those patients who need~     confirmation of the disease, are candidates for this study. Patients will be admitted~     annually to the Clinical Center for a maximum of five days. A history will be taken and a~     physical exam done. Blood and urine tests will be done along with brain wave recording,~     complete eye examination, psychological tests, and speech and language and rehabilitation~     evaluations. A maximum of 3 mL/kg of blood will be drawn from children and a total of 60 mL~     from adults. Various eye tests will also be done, some under sedation. DNA will be extracted~     for possible use in other studies. A skin biopsy will be taken on the first visit.~      There is a possibility of improved medical management and rehabilitative treatment as a~     result of participating in this study.~   "
273034|NCT00015769|"~     This study will explore the possible effectiveness of levetiracetam in patients with bipolar~     illness who have not responded adequately to standard treatments. Levetiracetam was recently~     approved to treat seizures. Other drugs in the same class as levetiracetam, including~     carbamazepine and valproate, are widely recognized as substitute medications for lithium or~     are used as an adjunct to it, and other anticonvulsants have also shown promise in improving~     bipolar symptoms.~      Patients with bipolar illness whose manic, depressed or unstable moods are not adequately~     controlled by their current treatment and who have not responded previously to two standard~     treatments (i.e., lithium, valproate, carbamazepine or neuroleptics) may be eligible for this~     study.~      Participants will take levetiracetam starting at 500 mg daily. If this dose is well~     tolerated, it will be increased to 500 mg twice a day. Every 3 days, doses may be increased~     until the target dose of 3000 mg/day is reached. Higher doses, not to exceed 4000 mg/day, may~     be tried in patients who do not respond fully to the lower doses. Patients and observers will~     use standard ratings to evaluate the patients' response to therapy during the 8-week study.~     If, after 8 weeks, the results appear promising, patients may continue treatment for an~     additional 6 months to evaluate longer-term effects.~   "
273035|NCT00015756|"~     This study will examine the relationship between bacterial products in lung infections in~     cystic fibrosis and disease severity. It will examine plasma and lung tissue from cystic~     fibrosis patients.~      Patients with cystic fibrosis and having certain genetic characteristics, who are between 9~     and 65 years of age and any cystic fibrosis patient undergoing lung transplantation at INOVA~     Fairfax Hospital in Fairfax, Virginia, may be eligible for this study.~      Patients who cannot undergo apheresis may be asked to provide up to an additional 100 cc (7~     tablespoons) of blood for research to look at bacterial products.~      Lung specimens of participating transplant patients will be collected at INOVA Fairfax~     Hospital. Patients who participate in the apheresis portion of the study will be admitted to~     the NIH Clinical Center for 2 to 3 days. Apheresis is a procedure for collecting large~     quantities of specific blood components. For this study, plasma-the liquid part of the~     blood-will be collected. For the procedure, whole blood is collected through a needle in an~     arm vein, similar to donating blood. The blood is separated into its components by~     centrifugation (spinning), the plasma and white cells are extracted and collected in a bag,~     and the red cells are returned to the body, either through the same needle or through another~     needle in the other arm.~      During the hospital stay, patients may also be asked to participate in other cystic fibrosis~     studies involving blood tests, an echocardiogram (ultrasound test of the heart), urine~     pregnancy test, and pulmonary function (breathing) tests.~   "
273044|NCT00015574|"~     Community based studies have shown increased cardiovascular mortality associated with acute~     exposures to particulate air pollution. Electrocardiographic changes have also been reported~     in animals exposed to particles in controlled conditions. We have hypothesized that~     cardiovascular patients may experience life-threatening arrhythmias associated with~     particulate air pollution episodes. Implanted cardioverter defibrillator (ICD) devices~     continuously monitor the heart rhythm, and on detecting arrhythmias can initiate~     interventions. These devices provide a passive, continuous monitor of cardiac arrhythmias. We~     are assessing the association between community exposures to air pollution measured by~     ambient monitors and these cardiac arrhythmias detected by implanted cardioverter~     defibrillator devices.~   "
273948|NCT00005324|"~     To identify genetic mechanisms controlling apolipoprotein levels and other 'non-traditional'~     risk factors in families ascertained through probands with premature coronary artery disease~     (CAD).~   "
273036|NCT00015717|"~     This study will use magnetic resonance imaging (MRI) to determine if silent strokes occur~     during angioplasty of the blood vessels in the neck or skull. Neck and skull angioplasties~     are relatively new procedures whose possible complications are still under investigation.~      Patients 18 years of age or older who are admitted to Suburban Hospital in Bethesda,~     Maryland, for angioplasty of one or more of the blood vessels in the neck or skull may~     participate in this study. Participants must be able to undergo a brain MRI. Within 24 hours~     before their angioplasty, patients will provide a medical history and have a physical~     examination and brain MRI. The physical examination and MRI will be repeated within 24 hours~     after the angioplasty.~      MRI is a diagnostic test that uses a magnetic field and radio waves to show structural and~     chemical changes in tissues. This technique is more sensitive than X-rays in detecting some~     changes that occur in diseases of the brain. For the procedure, the patient lies on a table~     that slides into a metal cylinder (the scanner). The confined space may produce anxiety in~     some patients, and patients can talk to the technician at all times during the procedure.~     Earplugs are provided to muffle loud knocking and pulsing noises that occur while the scanner~     is taking pictures. During the study, the contrast material gadolinium may be injected into~     an arm vein. Gadolinium brightens the pictures, producing better images of brain blood~     flow.~      Patients will be contacted by telephone 30 days after the procedure to follow how they are~     doing and learn whether any complications resulted from the angioplasty.~   "
273037|NCT00015678|"~     This study will investigate the effects of the drug flumazenil on brain excitability and the~     drug's relationship to a natural brain chemical called GABA. Flumazenil is commonly used in~     hospitals to reverse the effects of a group of drugs called benzodiazepines, one of which is~     Valium. Benzodiazepines act by enhancing the effects of GABA.~      Healthy volunteers 21 years of age and older may be eligible for this study. Candidates will~     be screened with a medical history and physical and neurological examinations.~      Participants will have transcranial magnetic stimulation (TMS) four times on two different~     days, before and after receiving an intravenous (through a vein) infusion of either~     flumazenil or placebo (an inactive sugar solution), as follows:~      TMS study 1~      Drug or placebo infusion~      TMS study 2 - 15 minutes after infusion~      TMS study 3 - 60 minutes after infusion~      TMS study 4 - 120 minutes after infusion~      In transcranial magnetic stimulation, a very brief electrical current is passed through an~     insulated coil wire placed on the scalp. These currents stimulate the cortex (outer part of~     the brain). They may cause muscle, hand, or arm twitching if the coil is near the part of the~     brain that controls movement, or they may affect other reflexes or movements. During the~     study, subjects may be asked to make movements, do simple tasks or tense muscles. To record~     the electrical activity of muscles, electrodes will be taped to the skin over the muscles~     tested. In some cases, the studies will be videotaped.~      Flumazenil will be infused through a catheter (thin plastic tube) attached to a needle placed~     in an arm vein. On one day, subjects will receive a 1-mg injection of flumazenil followed by~     a continuous infusion of 0.5 mg of the drug for about 30 minutes. On the other day, they will~     receive placebo, administered in the same manner.~   "
273038|NCT00015665|"~     This protocol provides for emergency treatment with the experimental anti-fungal drug~     voriconazole for patients with life-threatening invasive fungal infections. The increase in~     the number of patients whose immune function is suppressed because of chemotherapy, tissue or~     organ transplantation, or HIV infection has led to an increase in fungal infections. New~     drugs are needed to combat these infections in patients who do not respond to or cannot~     tolerate standard treatments.~      Patients on other primary NIH protocols who have an invasive life-threatening fungal~     infection that does not respond to currently available treatments or who cannot tolerate~     these treatments may be eligible for this study.~      Participants will have a blood test and a physical examination before receiving voriconazole.~     They will receive voriconazole twice a day either as an infusion into a vein or as tablets~     taken by mouth. Adult patients will be asked to provide a blood sample any time after the~     first dose of voriconazole to be used for developing a test to measure voriconazole~     concentration in the blood. Patients will be evaluated about 10 days after starting treatment~     and then at least once every 4 weeks with a symptom check and blood test.~   "
273039|NCT00015639|"~     Plasma histidine-rich glycoprotein (HRG) binds to platelets in the presence of zinc (1). This~     binding is totally blocked by a monoclonal antibody directed against platelet membrane CD36.~     Therefore, CD36 is assumed to carry the platelet binding site for HRG (2). Because CD36 also~     has a variety of other ligands, including polyanionic lipids, it is also possible that it~     contains the binding site for heparin (also polyanionic) and might be involve in the~     pathogenesis of heparin-induced thrombocytopenia. Demonstrating absent HRG or heparin binding~     to platelets lacking CD36 would confirm that the binding sites for either or both of these~     ligands are located on this membrane protein. Because 3% to 11% of healthy Japanese are~     reported to lack CD36 on their platelets, this population is a practical source of cells for~     examining the physiologic role(s) for CD36. Therefore, we will recruit blood donors from the~     Japanese community on the NIH campus. Their platelets will tested for the presence of CD36.~     Recruitment will be closed after two individuals have been identified whose platelets lack~     CD36 and who are willing to donate 30 cc of blood on 4 or 5 subsequent occasions for binding~     studies with radiolabeled HRG and heparin.~   "
273040|NCT00015626|"~     The goal of this study is to aggressively treat insulin resistance and its clinical~     manifestations when they first appear in childhood, and to prevent the subsequent progression~     towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical~     trial, we will learn more about the early manifestations of insulin resistance, its~     treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and~     in-vitro studies.~   "
273041|NCT00015613|"~     The most persistent and intractable cause of infant and child mortality and morbidity in the~     US remains preterm and low birthweight deliveries. Pregnant women in the United States~     experience the highest incidence of these complications among developed countries. Even more~     disturbing is the observation that immigrant Hispanic women experience worsening birth~     outcomes the longer they live here, despite increasing access to prenatal care, improved~     socio-economic status and better education. The purpose of this study is to identify the~     potential acculturation-related risk factors for preterm and low birthweight (PTLBW) delivery~     among Hispanic women of varying lengths of US residency. It is hypothesized that changes in~     factors associated with acculturation, such as poor nutritional intake, job stress and~     occupational exposures to pesticides or other hazards, and certain types of genital~     infections, can best explain the worsening of pregnancy outcomes among Hispanic immigrant~     women.~   "
273045|NCT00015561|"~     This project is designed to establish whether pesticides or other environmental agents have a~     role in the excess birth defects identified in the Red River Valley of Minnesota. In this~     human study, laboratory based health parameters will be used to key in health survey data. In~     vitro data will be developed to mechanistic information. Concordant results among these study~     features will provide a weight of evidence approach.~   "
273046|NCT00015548|"~     The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of~     Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease~     who are having trouble with their thinking or behavior. In particular, this study is trying~     to find out the best treatment for people who have hallucinations (seeing or hearing things~     that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to~     increase the chance that participants in the study receive a medication that helps them. The~     study uses three medications known as atypical antipsychotics (olanzapine, quetiapine,~     risperidone), which are the newest medications that are currently available for treating~     these problems. Participants may also receive an antidepressant (citalopram). The trial lasts~     for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this~     study is appropriate. In addition, the caregiver, family member, or friend who comes with the~     participant will be offered an educational program about Alzheimer's disease.~   "
273047|NCT00015483|"~     Hematotoxicity is caused by a number of agents such as a benzene by-product called~     hydroquinone and the antitumor agent doxorubicin. This is a basic research study, conducted~     using normal human donors, of mechanisms involved in hematotoxicity and of the protective~     response of human hematopoietic progenitor cells to hematotoxic agents. Tumor necrosis factor~     exposure protects these cells from a subsequent exposure to hematotoxic agents. The~     alteration of gene expression in these cells caused by tumor necrosis factor is being~     studied. Additionally, the tumor necrosis factor-induced biochemical pathways involved in~     protection of human hematopoietic progenitor cells will be studied.~   "
273048|NCT00015470|"~     The objectives of this protocol are to: 1) screen patients with various neuromuscular~     disorders and facilitate their entry into appropriate research protocols; 2) help resolve~     puzzling diagnostic neuromuscular problems and train fellows in the evaluation and treatment~     of Neuromuscular Diseases; and 3) provide follow up to patients who finished their~     participation in a previous study but they are not currently entered in another research~     protocol. No investigational treatments will be performed on this protocol but the tissues~     collected can be used for future research studies.~   "
273049|NCT00015457|"~     Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of~     botulinum toxin injections in the treatment of focal dystonia.~      Study Population: 20 patients with cervical dystonia~      Design: Double-bind, placebo-controlled clinical trail.~      Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale,~     NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers:~     Amplitude of EDB MEP.~   "
273050|NCT00015444|"~     Objective:~      The objectives of this protocol are:~      to develop and maintain a repository of clinically characterized patients with primary~     lateral sclerosis for future research protocols,~      to characterize the natural history of neurodegenerative disorders with corticospinal neuron~     degeneration,~      to investigate proposed etiologies, risk factors, and biomarkers for the development of these~     disorders and for disease progression~      Study Population:~      240 patients with adult-onset progressive spasticity with a diagnosis of primary lateral~     sclerosis or related upper motor neuron disorder~      Design:~      Patients who have been referred by physicians for primary lateral sclerosis will undergo a~     screening evaluation at the first visit. The screening visit will include review of outside~     medical records, neurological examination, and diagnostic testing to determine possible~     causes of spasticity. Patients fulfilling the clinical criteria for primary lateral sclerosis~     by history or examination will be followed to determine the natural history of this disorder.~     Measures of motor and cognitive function will be made at baseline and follow-up visits to~     follow clinical progression. Magnetic resonance imaging will be carried out to determine if~     imaging changes occur over time. Patients identified in this protocol who are eligible for~     other research protocols will be invited to participate in additional protocols.~      Outcome Measures:~      Clinical progression will be documented by measures of finger-tapping, timed gait, speech.~     The association between clinical progression and MRI measures will be assessed as a secondary~     outcome.~   "
273051|NCT00015431|"~     This study will determine whether people with common variable immunodeficiency (CVID) with~     and without gastrointestinal (GI) symptoms have gut abnormalities (inflammation or loss of~     function) and changes in immune system cells and chemicals in the blood and gut. People with~     CVID have decreased levels of serum immunoglobulin IgG and IgA. Patients have sinus, lung and~     other infections, and many also have stomach and intestinal problems, such as chronic~     diarrhea, inability to absorb nutrition from food, and intestinal infections caused by~     bacteria.~      CVID patients with gastrointestinal symptoms 10 years of age and older may be eligible for~     this study; CVID patients without gastrointestinal symptoms 18 years of age and older will be~     enrolled as control subjects. Candidates will be screened with a review of their medical~     records, a medical history and physical examination, HIV blood test, stool sample, and~     hydrogen breath test. The breath test measures the amount of hydrogen in the breath after~     drinking sugar water, showing the digestive effects of bacteria in the upper intestine.~      Participants will be admitted to the NIH Clinical Center for several days to undergo the~     following procedures:~        -  Medical history and physical examination~        -  Blood tests~        -  Urine and stool samples~        -  48-hour stool fat collection measures the amount of undigested fat in the stool to~          determine the ability of the gut to digest and absorb fat in the diet~        -  D-Xylose absorption test measures the ability of a sugar compound to travel across the~          lining of the intestine to determine the ability of the gut to absorb nutrients~        -  Upper endoscopy a thin flexible lighted tube is advanced through the mouth to evaluate~          the esophagus, stomach and beginning of the small intestine~        -  Lower endoscopy a thin lighted tube is advanced through the rectum to evaluate the colon~      Identification of GI abnormalities associated with changes in immune response in CVID~     patients will help in developing and testing new treatments for this disease.~   "
273052|NCT00015015|"~     Dichloroacetate (DCA) is a product of water chlorination and a metabolite of certain~     industrial solvents, thus making it a chemical of environmental concern. However, DCA is also~     used as an investigational drug for treating various diseases of adults and children, at~     doses far greater than those to which humans are normally exposed in the environment. Our~     research involves how DCA is metabolized by healthy adults and by children with a fatal~     genetic disease, congenital lactic acidosis (CLA) who are treated with DCA.~   "
273053|NCT00015340|"~     The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the~     treatment of opioid dependence. A compassionate use study.~   "
273054|NCT00015301|"~     The purpose of this study is to evaluate PET methodology to study in vivo synaptic dopamine~     release.~   "
273055|NCT00015288|"~     The purpose of this study is to examine pharmacokinetics and dose proportionality of~     sublingual tablets containing varying doses of buprenorphine and naloxone.~   "
273056|NCT00015275|"~     The purpose of this study is to define pathophysiological subtypes of abnormalities in~     subjects with cocaine dependence.~   "
273057|NCT00015249|"~     The purpose of this study is to assess the effects of chronic cocaine use on the acoustic~     startle response and on gating of this response in humans.~   "
273070|NCT00014989|"~     As many more premature infants survive, the numbers of these infants with health problems~     increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately~     20%. Magnesium sulfate, the most commonly used drug in the US to stop premature labor, may~     prevent CP. This trial tests whether magnesium sulfate given to a woman in labor with a~     premature fetus (24 to 31 weeks out of 40) will reduce the rate of death or moderate to~     severe CP in the children at 2 years. The children receive ultrasounds of their brains as~     infants and attend three follow-up visits over two years to assess their health and~     development.~   "
273071|NCT00014976|"~     This study will provide information about changes that occur in the motor neurons of the~     spinal cord (the nerve cells that control the muscles) when the motor cortex (the region of~     the brain that controls movement) is unable to send messages to the spinal cord and muscles~     in the normal way. This information will help elucidate how the nervous system adapts after~     injury or disease of the motor cortex.~      Healthy adult volunteers and adults with a spasticity disorder and moderate weakness may be~     eligible for this study. Patients will be screened with a medical history, physical~     examination and diagnostic studies as needed. Healthy volunteers will have a neurological~     examination. Muscle weakness and spasticity will be evaluated in both groups of subjects.~      All participants will have electromyography (measurement of electrical activity in muscles)~     during nerve stimulation and transcranial magnetic stimulation, described below. (Some~     patients, such as those with a pacemaker or implanted medication pumps, metal objects in the~     eye, history of epilepsy and others, will not have magnetic stimulation.)~      Electromyography - The electrical activity of muscles will be measured either by 1) using~     metal electrodes taped to the skin overlying a muscle, or 2) using thin wires inserted into~     the muscle through a needle.~      Nerve stimulation - The nerves will be stimulated by applying a small electrical pulse~     through metal disks on the skin of the arm or leg.~      Transcranial magnetic stimulation - A brief electrical current is passed through a wire coil~     placed on the scalp. This creates a magnetic pulse, which stimulates the brain. During the~     test, the participant may be asked to tense certain muscles slightly or perform other simple~     actions.~      Nerve block - Some patients will have a nerve block of one of the nerves in the arm. For this~     procedure, a local anesthetic is injected under the skin to produce numbness and weakness in~     some arm muscles.~   "
273072|NCT00014963|"~     This study compares air pollution exposures of residents in a South Baltimore community next~     to major industry with those in a comparison community with much less industry nearby.~     Parents and children as well as adults alone will be included. Air levels of 3 chemicals that~     have been found in increased amounts in the community as well as two urinary breakdown~     products of benzene will be measured. Participants will limit the amount of sorbate preserved~     foods they eat as this preservative interferes with one of the benzene breakdown products.~     Benzene air and urine exposure measurements will be compared in each community as well as~     between communities. By including children and parents we will gather exposure information on~     children who may be more sensitive that adults to these types of pollution. Lastly, by~     restricting the amount of food preserved with sorbates, we can decide if this improves the~     use of ttMA for people exposed to benzene from air pollution.~   "
273073|NCT00014950|"~     Although cystic fibrosis (CF) is the most common, life-threatening autosomal recessive~     genetic disorder of the white population, there are often delays in diagnosis and hence start~     of treatment. Advances of the past two decades have made CF screening feasible using~     routinely collected neonatal blood specimens and measuring an enzyme level followed by CF~     mutation DNA analysis. Our overall goal of the study is to see if early diagnosis of CF~     through neonatal screening will be medically beneficial without major risks. ''Medically~     beneficial'' refers to better nutrition and/or pulmonary status, whereas '' risks'' include~     laboratory errors, miscommunication or misunderstanding, and adverse psychosocial~     consequences. Specific aims include assessment of the benefits, risks, costs, quality of~     life, and cognitive function associated with CF neonatal screening and a better understanding~     of the epidemiology of CF.~      A comprehensive, randomized clinical trial emphasizing early diagnosis as the key variable~     has been underway since 1985. Nutritional status has been assessed using height and weight~     measurements and biochemical methods. The results have demonstrated significant benefits in~     the screened (early diagnosis) group. We are now focusing on the effect of early diagnosis of~     CF on pulmonary outcome. Pulmonary status is measured using chest radiographs, chest scans~     using high resolution computerized tomography, and pulmonary function tests. Other factors~     that we are looking at include risk factors for the acquisition of respiratory pathogens such~     as Pseudomonas aeruginosa, quality of life and cognitive function of children with CF who~     underwent early versus delayed diagnosis, as well as the cost effectiveness of screening and~     the costs of diagnosis and treatment of CF throughout childhood.~      If the questions underlying this study are answered favorably, it is likely that neonatal~     screening using a combination of enzyme level (immunoreactive trypsinogen) and DNA test will~     become the routine method for identifying new cases of CF not only in the State of Wisconsin,~     but throughout the country.~   "
273074|NCT00014898|"~     We are examining the past exposure to lead in 250 well characterized children with ADHD, and~     a suitable group of controls. Our measure of past exposure is bone lead levels obtained by~     XRay fluorescence spectroscopy, a relatively new way of estimating bone lead concentrations,~     and by inference, body lead burdens. By comparing the lead concentrations in these two~     groups, controlling for other factors which could confound, we will estimate odds ratios for~     ADHD given elevated bone lead, and estimate the contribution of lead to this disease of~     childhood.~   "
273075|NCT00014885|"~     This project studies the relationship between lead exposure and academic achievement in~     college students. Most studies of the neurobehavioral effects of lead have focused on~     performances at the low end of the distribution. There is evidence that lead affects outcome~     across the entire distribution. This is a retrospective cohort study of subjects whose~     cognitive function is adequate to gain admission to college. We will use x-ray fluorescence~     to measure bone lead concentrations in undergraduate college students and test the hypothesis~     that achievement scores are related to early lead exposure. Early lead exposure has been~     shown to have measurable effects on academic performance and neurobehavioral outcomes at 18~     years of age. Should an effect be found in this study, the spectrum of lead toxicity would be~     expanded to include subjects with above average function.~   "
273076|NCT00014872|"~     To investigate the role of genes and energy metabolism in the pathogenesis of obesity in~     adolescent Black girls.~   "
273077|NCT00014859|"~     The purpose of this study is to test the hypothesis that excess, rare, functionally~     disruptive single nucleotide polymorphisms (SNPs) characterize genes (e.g., the surfactant~     protein-B gene)(SFTPB) and gene networks (e.g., the pulmonary surfactant metabolic network)~     associated with increased risk of neonatal respiratory distress syndrome (RDS).~   "
273078|NCT00014833|"~     To investigate the inverse association between socioeconomic status (SES) and cardiovascular~     disease (CVD) in the Atherosclerosis Risk in Communities (ARIC) Study cohort.~   "
273079|NCT00014820|"~     To study work-related asthma in a low-income, urban population.~   "
273080|NCT00014807|"~     This is a community-based participatory research program focusing on pesticide contamination~     in migrant farmworker families.~   "
273161|NCT00012961|"~     Schizophrenia exacts a high toll on the lives of patients and their families and constitutes~     a major health care cost. VISN 5 has placed special emphasis on improving care for veterans~     with severe mental disorders, an effort recently recognized by the VA as a Program of~     Excellence in the Care of Seriously Mentally Ill Veterans.~   "
273949|NCT00005323|"~     To conduct an epidemiologic study of persistent pulmonary hypertension of the newborn ( PPHN)~     infant.~   "
273081|NCT00014794|"~     This study will test whether positron emission tomography (PET) imaging can be used to~     measure blood flow to joints in patients with rheumatoid arthritis (RA). It will also compare~     blood flow measurements using PET with measurements obtained with magnetic resonance imaging~     (MRI) to determine how useful MRI is in measuring blood flow to joints.~      Much of the joint damage in RA is caused by the synovium-the lining of the joint. In RA, the~     synovium increases in size and destroys bone and cartilage. The synovium maintains its growth~     by forming many new small blood vessels to nourish it. New drug treatments are being~     developed to stop the growth of these new blood vessels. The effect of these treatments on~     the synovium is usually measured by performing a biopsy-removing a small piece of synovium~     for examination under a microscope. The biopsy requires inserting a needle into the joint to~     withdraw the synovial tissue. This study will see if changes in blood flow can be assessed~     accurately using noninvasive imaging procedures, such as PET scanning, instead of a biopsy.~      Patients 18 years of age and older with rheumatoid arthritis who have at least one tender and~     swollen knee due to synovitis may be eligible for this study. Candidates will be screened~     with a medical history and physical examination.~      Participants will have a mold made of the knee to be studied and will have routine blood~     tests. Women who are able to become pregnant will have a pregnancy test. All participants~     will then undergo PET and MRI scanning as described below:~      PET - A needle is used to insert a catheter (small plastic tube) into an arm vein for~     injection of the radioactive substance H215O. The patient lies in a doughnut-shaped machine~     (the PET scanner) and a quick scan is done to measure body thickness. Then, a separate scan~     is taken following each of six or fewer injections of H215O. Each scan lasts about 13~     minutes.~      MRI - The patient lies on a stretcher that is moved into a cylinder containing a magnetic~     field (the MRI scanner). A special coil is placed over the knee to improve the quality of the~     images. Earplugs are worn to muffle the loud thumping sound produced by electrical switching~     of the magnetic fields during the imaging. A contrast agent called gadolinium is injected~     through a catheter into a vein to improve the quality of the images. An intercom system~     permits the patient to communicate with the technician at all times during the procedure.~   "
273082|NCT00014781|"~     OBJECTIVES:~      I. Determine the amount of hepatic glucose production derived from gluconeogenesis and~     glycogenolysis in the post-absorptive state in patients with cystic fibrosis.~      II. Determine de novo lipogenesis in relationship to resting energy expenditure in this~     patient population.~   "
273083|NCT00014768|"~     OBJECTIVES: I. Compare the clinical status of pregnant vs non-pregnant women with cystic~     fibrosis.~      II. Determine glucose tolerance during each trimester of pregnancy in these women.~      III. Evaluate peripheral insulin sensitivity in these women. IV. Evaluate whole body protein~     turnover and hepatic glucose production in these women.~      V. Determine resting energy expenditure in these women.~   "
273084|NCT00014755|"~     OBJECTIVES: I. Determine the toxicity of total-body irradiation, anti-thymocyte globulin, and~     cyclophosphamide followed by syngeneic or autologous peripheral blood stem cell (PBSC)~     transplantation in patients with multiple sclerosis.~      II. Determine the disease response of patients treated with this regimen. III. Determine the~     safety and efficacy of filgrastim (G-CSF) for PBSC mobilization in this patient population.~   "
273085|NCT00014742|"~     OBJECTIVES: I. Compare the safety and efficacy of clostridial collagenase vs placebo in terms~     of improving the degree of flexion deformity, range of finger motion, and grip strength in~     patients with residual stage Dupuytren's disease.~      II. Compare the overall clinical success rate, time to return to normal finger contracture to~     within 0-5 degrees of normal (zero degrees), and frequency of cord rupture in the joint of~     patients treated with these regimens.~      III. Compare the baseline change in degree of finger flexion deformity, range of motion of~     the treated finger, and strength of hand grip (in pounds) in patients treated with these~     regimens.~      IV. Compare the frequency distribution of the number of patients with reduction in finger~     contracture to within 0-5 degrees of normal (zero degrees) and the number who require~     re-treatment with open-label collagenase after treatment with these regimens.~   "
273086|NCT00014729|"~     OBJECTIVES:~      I. Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis~     bullosa.~   "
273087|NCT00014040|"~     This study will test whether inhaling nitric oxide gas can improve blood flow to the heart,~     ventricular function, exercise tolerance in patients with coronary artery disease and chest~     pain that has not improved with medical or surgical therapy.~      Patients with coronary artery disease who have chest pain despite treatment with medicines~     and angioplasty or surgery may be eligible for this study. Those enrolled will receive~     monetary compensation for their participation in this study.~      The duration of the study is 5 days, with 2 testing periods lasting 2 days each. During one~     of the periods, the study participants will breathe nitric oxide mixed with room air through~     a face mask during the tests. During the other period, the participants will breathe room air~     alone through a face mask during the tests. At least 1 day will separate the treatment~     periods. During each of the 2 treatment periods (nitric oxide and room air), participants~     will undergo 4 tests to determine whether the treatment improves the heart's response to~     stress with increased heart rate and contraction. Approximately one hour before each of the~     tests, participants will breathe either nitric oxide mixed with room air or room air alone~     through the face mask, and continue the inhalation treatment while each test is being~     performed. The face mask will be removed at the end of each test.~      On the morning of the first day of each treatment period, participants will have a special~     echocardiogram with imaging of the heart. The echocardiogram will be performed during an~     infusion of dobutamine, a medicine that increases heart rate and contraction, and serves to~     stress the heart. This manner of stress testing is commonly used in hospitals around the~     country to determine if walls of the heart are receiving sufficient blood supply. That~     afternoon, participants will undergo a magnetic resonance imaging (MRI) study of the heart.~     The MRI will determine the heart's blood flow and contraction while receiving the same dosage~     of dobutamine as was used earlier in the day. On the morning of the second day of each~     treatment period, participants will exercise on a treadmill until moderately uncomfortable~     chest pain is reported. Later that morning, participants will undergo cardiac~     catheterization. For the cardiac catheterization, a long tube (catheter) will be placed into~     a vein of the neck once the skin is numbed with xylocaine. This tube will be positioned~     within the right atrium of the heart and into a tube-like structure called the coronary~     sinus, where venous blood exits the heart muscle. A small catheter will also be placed in an~     artery of the upper forearm after the skin has been numbed with xylocaine. Blood samples will~     be taken to allow us to measure the amount of nitric oxide transported in the blood. The~     blood samples will be drawn (through the tube in the heart and through the small tube in the~     artery) at the beginning of the study and during infusion of dobutamine to stress the heart.~     The dose of the dobutamine infusion will be the same dose used in the previous day's stress~     studies.~      After the completion of the first treatment period, we will stop testing for at least one~     day. Participants will begin the second treatment period with the inhalation treatment not~     received during the first treatment period.~   "
273088|NCT00014027|"~     This research study is designed to find out if increasing the dietary intake of~     polyunsaturated fats improves concentration, motor skills and cardiovascular responses under~     stress. These polyunsaturated fats may also change the chemicals in the brain that control~     these responses. Specifically, these polyunsaturated fats may raise brain levels of~     neurotransmitters called dopamine and serotonin. Polyunsaturated fats are important for~     improving the function of both the brain and the heart. People cannot make these~     polyunsaturated fats and they can only be obtained from the oils that we eat. For three~     months subjects will take 8 capsules a day that contain either corn oils flavored with fish~     oils or fish oil that taste a little like corn oils. Subjects will not be told which oils we~     expect to work better. An initial evaluation will determine if subjects fit the criteria~     necessary to enter the study. A battery of tests will be conducted twice, once before~     starting the capsules and again after three months of taking the capsules. These batteries of~     tests will include an MRI of the head, paper and pencil tests to evaluate changes in mood,~     and tests of concentration and motor skills and cardiovascular responses under stress. Two~     lumbar punctures will be performed to collect cerebrospinal fluid so that changes in~     neurotransmitters can be evaluated. Subjects will be on a no seafood diet to equalize their~     dietary intake of polyunsaturated fatty acids. Subjects will be expected to complete all~     parts of this study.~   "
273204|NCT00011791|"~     This study will examine and compare the effects of intense exercise on the release of~     catecholamines in patients with congenital adrenal hyperplasia (CAH) and in healthy persons.~     Catecholamines are hormones (adrenaline and noradrenaline) that are produced by the adrenal~     glands and released into the blood stream during stress, such as trauma, illness, intense~     exercise, or low blood sugar. The study will also assess exercise tolerance in patients with~     CAH, compared with healthy persons.~      Patients with CAH between the ages of 10 and 40 years who are managing well on standard~     treatment (glucocorticoids, mineralocorticoids) may be eligible for this study. Healthy~     volunteers that match the enrolled patients in age, sex, race and body fat will be recruited~     as control subjects. All candidates will be screened with a medical history, physical~     examination and electrocardiogram (EKG). Body fat will be measured using an instrument called~     a Bod Pod. The body fat measurement has two parts: first, the subject sits quietly in a large~     egg-shaped capsule for about 2 to 3 minutes; then the subject breathes into a plastic tube~     for one minute, followed by three quick panting breaths. Women will have a urine pregnancy~     test; pregnant women cannot participate in the study.~      Participants will undergo three exercise sessions on separate consecutive mornings after~     fasting overnight. Before each test, patients (not healthy volunteers) will take either an~     additional morning dose of hydrocortisone or a placebo (a lookalike pill with no active~     ingredient). Before each test a thin catheter (plastic tube) will be placed into an arm vein~     through a needle. A numbing cream can be applied to make the needle stick hurt less. Blood~     will be drawn through this intravenous (IV) line before, during and after the exercise tests.~     The first test is a maximal exercise test to determine the individual's maximum exercise~     fitness capacity. The second two and third tests are a standardized exercise tests. Before~     the two standardized tests, patients (not healthy volunteers) will take either an additional~     morning dose of hydrocortisone or a placebo (a lookalike pill with no active ingredient). All~     tests are done on a stationary bicycle.~      Maximal Exercise Test - The subject pedals on a stationary bicycle for about 10 minutes.~     After a 3-minute warm-up, the workload is increased continuously until either the subject can~     no longer continue or the physician stops the test for medical reasons. During the exercise,~     heart rate and heart activity are monitored with an EKG, and the subject wears a nose clip~     and mouthpiece connected to a breathing tube to measure oxygen use. Blood is drawn before and~     during the test, totaling no more than 2 tablespoons.~      Standardized Exercise Test - The subject pedals on a stationary bicycle for 20 minutes, while~     wearing the nose clip and mouthpiece to measure oxygen use. For the first 5 minutes, the~     subject pedals at a speed that elicits 50 percent of maximal effort (determined by the~     maximal exercise test); the next 10 minutes are at 70 percent of maximal effort; and the last~     5 minutes are at 90 percent. Blood samples drawn before, during (at 15 and 20 minutes) and~     after exercise (at 30, 40 and 60 minutes) total less than 1/2 cup. Heart rate and heart~     activity are monitored during the test with an EKG, and temperature is measured before and at~     the end of the test.~   "
273205|NCT00011778|"~     This study will test the safety and effects of the experimental drug PS-341 plus radiation~     therapy in patients with head and neck cancer. PS-341 can slow or halt the growth of cancer~     cells grown in culture or in mice. In addition, the drug appears to enhance the effectiveness~     of radiation treatment.~      Patients 18 years of age and older with head and neck cancer that cannot be treated~     adequately with surgery and cannot be cured with standard radiation and chemotherapy may be~     eligible for this study. Patients whose cancer has spread to the brain may not participate.~      Before treatment begins participants are evaluated with CT or MRI scans of the head, neck and~     chest area to determine the extent of the cancer; an electrocardiogram and blood tests; and a~     neurocardiovascular evaluation that includes measuring blood pressure in different body~     positions and involves injections of phenylephrine and nitroglycerine. Some patients may~     undergo a procedure in which a tube is inserted into the larynx (voice box), bronchi~     (breathing tubes) and esophagus (food tube) and tissue samples removed. This procedure is~     done under general anesthesia in the operating room.~      Patients receive radiation treatments Monday through Friday and injections of PS-341 twice a~     week during the radiation therapy. After 3 weeks of treatment, PS-341 injections are stopped~     for 2 weeks. Some patients continue to receive radiation treatments during the 2-week break,~     and others do not, depending upon when they enter the trial. The total duration of radiation~     treatment varies from 6 to 8 weeks, depending on whether the patient received radiation in~     the region of the head and neck cancer before entering the study.~      Patients have a blood sample drawn before and after each new PS-341 injection to measure the~     drug action in the blood and to see how strong and how long the effects on the blood last.~     They are seen in the clinic at least once a week for a history and physical examination. A~     blood sample is collected at each visit to look for toxic effects of PS-341. Near the end of~     treatment, the neurocardiovascular evaluation is repeated, and if the results are abnormal,~     it is repeated again 3 months after treatment is completed. X-rays or MRI scans are done 12~     weeks after radiation therapy has ended and then every few months after that to determine the~     extent of disease. Patients whose tumor is accessible are asked to undergo a biopsy (removal~     of a small piece of tumor tissue) on the first and second day after receiving the first~     PS-341 dose to examine the effect of the drug on the tumor.~      The PS-341 dose is increased in successive groups of at least 3 patients until the highest~     dose that can be given safely with radiation is reached. Patients who develop severe side~     effects from the drug temporarily stop taking it to allow the side effects to improve. If~     needed, the dose may be decreased. Radiation therapy may also be stopped temporarily in~     patients who develop severe effects on the mouth, throat or skin. Side effects may be treated~     with increased fluid (by mouth, stomach tube, or vein), anti-nausea or anti-diarrhea~     medications, pain medications and medications to boost red or white cell counts or platelets.~     The drug Florinef may be given to help regulate body fluids and blood pressure.~   "
273206|NCT00011765|"~     This study will evaluate whether fluoxetine (Prozac), used together with traditional~     psychotherapy, can reduce aggression in people who are physically violent towards their~     spouses or significant others. Treatment for domestic violence has centered on behavioral~     therapies, such as anger management and self-control exercises. Recent studies have shown~     that fluoxetine-a drug commonly used to treat depression and panic disorder-can decrease acts~     of aggression.~      Men and women between the ages of 18 and 65 who have a history of inflicting physical~     aggression on a spouses or significant others in the past year (with at least one episode~     occurring not under the influence of alcohol) may be eligible for this study. Participants~     spouses or significant others will also be asked to participate. All potential participants~     will be screened with a medical and psychiatric evaluation and history, breath alcohol~     analysis, blood tests, urine drug screen and electrocardiogram.~      Those enrolled will undergo the following procedures:~      Perpetrator~        -  Interview and questionnaires - Participants will be interviewed by a social worker about~          past and current mental health and use of alcohol and illicit drugs and will complete~          questionnaires assessing emotional state and personality, depression, anxiety,~          aggression and alcohol consumption. Some of the questionnaires will be repeated at~          monthly intervals.~        -  Physical performance testing - Performance and speed will be measured in three separate~          training sessions that involve repeatedly pressing a button on a button box console,~          earning points worth money.~        -  Dyadic interaction paradigm - Participants will interact with their spouse/significant~          other in a small room, first discussing a neutral topic, such as the day's events, and~          then a subject that has been a source of conflict.~        -  Fluoxetine administration - Participants will be randomly assigned to receive either 10~          mg. of fluoxetine or placebo (identical capsules with no active ingredients) once a day~          for 3 days, then twice a day, increasing up to four capsules a day if there are no~          serious side effects. Blood will be drawn once a month to measure drug levels. At the~          end of 3 months, participants taking placebo may remain in the study and receive~          fluoxetine.~        -  Clinic visits - Participants are followed in the clinic weekly for the first month, then~          twice a month for the next 2 months for adjustment of number of pills, evaluation of~          aggressive behavior and alcohol consumption, and therapy for issues of self-esteem,~          anger management and communication skills. Couples therapy aimed at conflict resolution~          and improving communication skills will be offered.~        -  Genetic tests (optional) - Blood will be drawn to determine if there is a relationship~          between genes involved in a chemical process (serotonin reuptake) that is influenced by~          fluoxetine and the participant's response to the drug.~      Spouse/Significant other:~      Spouses/significant others will complete several questionnaires once a month (total 4 times)~     to rate their partners' behavior while in the study. They will also participate in the dyadic~     interaction paradigm described above at the beginning and end of the study.~   "
273089|NCT00014001|"~     The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention~     Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the~     long-term effects and usefulness of antipsychotic medications in persons with schizophrenia.~     It is designed for people with schizophrenia who may benefit from a medication change. The~     study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone,~     clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine~     decanoate). All participants will receive an initial comprehensive medical and psychiatric~     evaluation and will be closely followed throughout the study. For most participants the study~     will last up to 18 months. Everyone in the study will be offered an educational program about~     schizophrenia and family members will be encouraged to participate.~   "
273090|NCT00013975|"~     This study will measure and compare the levels of endothelial progenitor cells (EPCs) in the~     blood of people with and without risk factors for atherosclerosis (hardening of the arteries)~     to see if there is a relationship between these cells and cardiovascular risk factors such as~     smoking, high cholesterol level and high blood pressure.~      Healthy male volunteers between the ages of 21 and 55 years with and without heart disease~     risk factors may be eligible for this study. Candidates must have no evidence of coronary or~     peripheral vascular disease, proliferative retinopathy, or other chronic disease and no~     history of cancer, migraine-type headache, cluster headache, raised intraocular pressure,~     raised intracranial pressure, hyperthyroidism.~      Participants will undergo the following procedures at the NIH Clinical Center:~        -  Medical history and physical examination~        -  Blood tests to measure EPC level and various risk and growth factors~        -  Brachial reactivity study - This ultrasound study tests how well the subject's arteries~          widen. The subject rests on a bed for 30 minutes. An ultrasound measuring device is~          placed over the artery just above the elbow. The size of the artery and blood flow~          through it are measured before and after inflating a pressure cuff around the forearm.~          The pressure cuff stops the flow of blood to the arm for a few minutes. After a~          15-minute rest, the drug nitroglycerin is sprayed under the subject's tongue. Before the~          nitroglycerin spray and 3 minutes after it, the size of the artery and blood flow~          through it are measured again.~   "
273091|NCT00013962|"~     The Williams syndrome is a disease in which supravalvular aortic stenosis, an elfin facies,~     mental retardation and other congenital defects are sometimes associated with abnormal~     vitamin D and calcium metabolism. Whereas some patients have been reported to show increased~     sensitivity to vitamin D or an exaggerated response of serum 25-hydroxyvitamin D {25(OH)D} to~     administration of vitamin D and to have hypercalcemia caused by increased circulating~     1,25-dihydroxyvitamin D{1,25(OH)2D} in infancy and early childhood, most patients have normal~     calcium metabolism and normal values for circulating 25(OH)D and 1,25(OH)2D. We propose to~     carry out further studies of vitamin D metabolism to elucidate the mechanism(s) for abnormal~     vitamin D metabolism. We will determine the response of serum 1,25(OH)2D to administration of~     1,25(OH)2D3. Measurement of the 1,25(OH)2D in the patients compared to normal subjects will~     be the primary outcome.~   "
273092|NCT00013949|"~     This project is part of a program project directed toward assessing cardiac effects of~     particulate and other ambient air pollutants. In this project active elderly adults living in~     the communities of Boston and Steubenville have attended 12 weekly sessions including~     approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation~     before, during, and after outdoor exercise. To investigate the relation of air pollution to~     cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of~     blood pressure and symptom data and downloading of available repeated measures telemetry data~     in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated~     weekly exercise training sessions in a major hospital cardiac rehabilitation unit.~   "
273093|NCT00013936|"~     The purpose of this protocol is to develop a valid, reliable, better standardized, and more~     efficient test of visual acuity (ability to see fine details) for use in clinical trials.~     Recent improvements in computer video hardware permit calibration, characterization, and~     accurate rendering of eye-chart-quality letters. The computer can then be used to measure~     acuity. The modified binary search (MOBS) testing strategy is one method of computer-based~     testing. This study will compare the accuracy, precision, stability and utility of the MOBS~     technique with the eye chart method used in the National Eye Institute's Early Treatment for~     Diabetic Retinopathy Study (ETDRS). The ETDRS method is currently the gold standard for~     acuity testing in clinical trials.~      Study subjects will include NEI clinic patients between 7 and 90 years of age with or without~     eye disease. Eye diseases include poor visual acuity, age-related macular degeneration,~     cataract, optic nerve abnormality, corneal abnormality, uveitis, glaucoma, other retinal or~     choroid abnormality, amblyopia or other eye disease.~      Participants will have their vision tested in each eye using both the ETDRS eye chart method~     and the MOBS method. The ETDRS method will require subjects to read all the letters on the~     chart until they can no longer see the details. For the MOBS method, they will read a single~     letter at a time that will appear on the computer screen. After reading each letter, a new~     letter will be presented that is either bigger or smaller in size. After completing the last~     acuity test, participants will fill out a questionnaire regarding their preference for one~     test type over the other.~   "
273094|NCT00013923|"~     The purpose of this study is to evaluate the effectiveness of a nutritional supplement that~     has been developed to improve the brain function of a patient with Alzheimer's disease.~   "
273100|NCT00013819|"~     This is a study of the effects that lead has on the health of the central nervous system (for~     example, memory), peripheral nervous system (for example, sensation and strength in the hands~     and fingers), kidneys, blood pressure, and the blood forming system. A total of 803 lead~     workers and 135 persons without occupational lead exposure are being studied in South Korea.~     Lead in the body is being assessed by measurement of blood lead, chelatable lead (an estimate~     of lead in the tissues), and lead in bone. Subjects are tested three times each over three~     years. Several genetic factors are also being assessed for the role they play in the health~     effects of lead. These genes are known to differ among individuals. We are interested to know~     whether different forms of the same genes can modify the effect lead has on health.~   "
273604|NCT00005891|"~     OBJECTIVES:~      I. Determine the effectiveness of moderate dose cyclophosphamide and total lymphoid~     radiotherapy in terms of improving the survival and reducing the morbidity following~     allogeneic bone marrow transplantation in patients with Fanconi's aplastic anemia.~   "
273095|NCT00013910|"~     The purpose of this research study is to investigate the mechanism of action of a new~     investigational medication (drug), NNC 90-1170, which is being developed for the treatment of~     type 2 diabetes (adult onset type of diabetes.~      NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is~     important for controlling insulin levels. Insulin, another hormone, is also important for~     controlling blood glucose levels, which are higher than normal in people who have type 2~     diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to~     cause insulin to be released from the pancreas in response to increasing blood glucose~     concentrations. These results will be compared to that of a group of healthy volunteers of~     similar age and body weight who do not have diabetes. Also, various other hormones and~     substances that are known to control blood sugar will be measured in blood samples that will~     be drawn.~      One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study,~     and the effects of this dose will be compared to a placebo (inactive substance that looks~     like the active drug). This is a crossover study, which means that subjects will be treated~     both with NNC 90-1170 and with placebo. The order in which subjects will receive the~     treatments will be determined by chance (randomly).~      The study will be conducted as a so-called double-blind study, meaning that neither~     subjects nor study doctors will know the order in which subjects will be given each treatment~     until the study is over.~      The study will include approximately 15 healthy volunteers and 15 volunteers with type 2~     diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in~     the United States.~   "
273096|NCT00013858|"~     This study is designed to examine the effects of prenatal exposure to environmental~     contaminants on cognitive and behavioral development and physical growth in two groups of~     Inuit infants-one in Northern Quebec; the other in Greenland.~   "
273097|NCT00013884|"~     This study will evaluate whether a drug called T-20 can slow or prevent a rapid return of HIV~     in the blood when HAART (highly active antiretroviral therapy) is stopped temporarily. HAART~     is a multi-dose regimen that is very effective in suppressing HIV and perhaps slowing or~     halting progression of the viral infection towards AIDS. However, this treatment is not~     problem-oriented. It cannot completely rid the body of virus, and long-term therapy carries a~     risk of toxicity (harmful side effects). Moreover, the treatment is difficult to adhere to~     because of the many pills and capsules that must be taken daily. When patients stop taking~     HAART, their viral levels climb again. This study will see if T-20 can prolong the time it~     takes for HIV blood levels to rise in patients who stop HAART temporarily. The results may~     provide insight into possible new HAART-sparing treatments.~      HIV-infected patients 18 years of age and older who have received HAART for at least 1 month~     may be eligible for this study. Candidates will be screened with a medical history, physical~     examination, blood and urine tests and possibly a chest X-ray and electrocardiogram (EKG).~      Participants will receive either 100 Mg. of T-20 twice a day or 200 Mg. once a day, injected~     under the skin, and their normal HAART regimen for 3 days. (Patients or a caregiver will be~     taught how to give the T-20 injections.) On the fourth day, HAART will be stopped and all~     patients will receive 100 Mg. of T-20 twice a day for 6 weeks. Blood will be drawn weekly~     from the second to the sixth week after stopping HAART to check viral levels and CD4+ T cell~     counts. At the end of the 6 weeks, T-20 will be stopped and HAART will be restarted. Patients~     will then be evaluated once a month until their viral level is less than 50. The final clinic~     visit will be one month after this time.~      In addition to blood draws, patients will undergo leukapheresis before beginning T-20 and~     possibly again when they restart HAART and at the end of the study. For this procedure, whole~     blood is collected through a needle placed in an arm vein, similar to donating blood. The~     blood circulates through a machine that separates it into its components. The white cells are~     then removed, and the red cells, platelets and plasma are returned to the body, either~     through the same needle used to draw the blood or through a second needle placed in the other~     arm. The white cells are used to study T cell function and levels and to detect hidden virus.~   "
273098|NCT00013845|"~     This protocol has three purposes: 1) to screen patients with seizures for participation in~     research studies of NINDS s Clinical Epilepsy Section (CES), 2) to follow the natural course~     of seizure disorders, and 3) to train CES fellows in evaluating and treating epilepsy. Only~     standard diagnostic tests and treatments will be used in this study.~      Patients of any age with seizures who are referred to CES may participate in this study. At~     the end of the study, patients may be discharged to the care of their referring physician,~     offered participation in another NINDS research protocol, or followed for teaching purposes.~      Participants will undergo standard diagnostic procedures used to determine the type of their~     seizures, what part of the brain they are coming from, what is causing them, and whether~     standard drug treatments can help them. These may include some or all of the following:~        -  Physical and neurological examination~        -  Neuropsychological tests tests of learning and memory~        -  Electroencephalography (EEG) brain wave recording~        -  Evoked potentials tests of nerve reactions to lights and sounds~        -  Polysomnography simultaneous recordings of brain waves, breathing and eye movements~        -  Video-EEG monitoring simultaneous recording of seizures using a video camera and brain~          waves~        -  Video-EEG monitoring with extra electrodes to record muscle activity, breathing and eye~          movements for analyzing sleep patterns~        -  Imaging studies, such as magnetic resonance imaging (MRI) and positron emission~          tomography (PET) scans to examine the structure and function of the brain~        -  Frequent blood tests to measure blood levels of anti-seizure drugs~   "
273099|NCT00013832|"~     This study will examine tongue strength and endurance, how the tongue applies pressure during~     swallowing, and how the chin muscles react during swallowing in healthy volunteers and in~     patients with dysphagia (difficulty swallowing). The information from this study may be~     helpful in developing better treatments for people with swallowing problems.~      Healthy volunteers who have no history of speech, swallowing or breathing problems and~     patients who have difficulty swallowing because of a neurologic disorder, musculoskeletal~     disease or head and neck cancer that caused tongue weakness and dysphagia may be eligible for~     this study. Such medical conditions may include stroke, Parkinson's disease, multiple~     sclerosis corticobasal degeneration, progressive supranuclear palsy, Gaucher's disease,~     leukodystrophy, cerebral palsy, myositis, or mouth, throat or neck cancer. Volunteers who~     have not participated in a NIH protocol for 1 year will be screened with a brief medical~     history and physical examination. Dysphagic patients not currently enrolled in a NIH protocol~     will also have a brief medical history and physical examination. In addition, they will have~     a modified barium swallow to determine the nature and degree of their swallowing difficulty.~      Participants will have a 15-minute examination of movements of their tongue, lips and jaw and~     will fill out a questionnaire about their swallowing ability. They will then begin the tongue~     pressure test. To monitor and record tongue pressure, a thin rubber strip with air-filled~     pressure bulbs will be attached to the roof of the mouth with dental adhesive. The pressure~     bulbs are connected to an external pressure-reading device. In addition, a small plastic pad~     with adhesive backing will be placed under the chin. Electrodes (wires) attached to the pad~     record chin muscle activities.~      With the pressure bulbs and chin electrodes in place, the patient will perform tongue~     pressure tasks to test tongue strength, how long the patient can maintain a certain tongue~     pressure, and how fast tongue pressure drops. The tasks include saliva swallows, water~     swallows and cup-drinking.~   "
273101|NCT00013806|"~     131I-metaiodobenzylguanidine (131I-MIBG) is a norepinephrine analog that concentrates in~     adrenergic tissue and therefore holds promise for cell-specific treatment of neuroblastoma.~     This is a dual institution, Phase II study of 131I-MIBG administered at the previously~     defined maximum practical dose of 18 mCi/kg to children with relapsed or refractory~     neuroblastoma.~   "
273950|NCT00005322|"~     To identify genes involved in the pathogenesis of congenital heart disease, including atrial~     septal defects (ASDs), paramembranous ventricular septal defects (VSDs), and atrioventricular~     canal defects (AVCDs).~   "
273102|NCT00013793|"~     The primary purpose of this randomized clinical trial is to test the efficacy of motivational~     enhancement (ME) therapy combined with biologic feedback (fetal ultrasound) for increasing~     smoking quit rates among low-income pregnant women considered resistant smokers. We~     hypothesize that ME along with biofeedback will increase the rate of validated smoking~     cessation at 8 months gestation by at least 10 percentage points above that produced by Best~     Practice (BP) counseling alone. This study will also examine reduction of smoking among~     non-quitters and maintenance of smoking cessation through 6 weeks postpartum among women who~     quit.~      Prenatal smoking is the leading preventable cause of low birth weight in the US. Reduction in~     smoking during pregnancy could result in significant improvements in pregnancy outcomes and~     reducing the cost of health care. There is evidence that low-intensity pregnancy smoking~     cessation programs may be inadequate for women who are more addicted, and at educational and~     economic disadvantage. Motivational enhancement strategies have shown considerable promise in~     the treatment of addictive behaviors. Physiological feedback highlighting prenatal effects of~     smoking and benefits of cessation has been found to enhance prenatal smoking cessation~     counseling. An intervention that combines motivational enhancement counseling and~     physiological feedback may have powerful effects beyond low-intensity interventions or usual~     counseling.~   "
273103|NCT00013780|"~     Ozone is an air pollutant formed in at ground level by the chemical reaction between oxygen~     and automobile emissions in the presence of sunlight. The objective of this research is to~     determine how lung size, chemical composition, and normal functioning of the respiratory~     system affect the amount of inhaled ozone that reaches internal sites of tissue irritation~     and damage. To infer the distribution of inhaled ozone within the respiratory system,~     measurements of ozone concentration and air flow are made just outside the nose and mouth of~     healthy subjects who breathe laboratory-generated, ozonated air for about one hour.~     Biochemical composition of respiratory mucus is then inferred from nasal washings made with~     salt water. The amount of ozone that a subject retains in one of these experiments is less~     than the daily exposure in a large city such as New York or Los Angeles.~   "
273104|NCT00013767|"~     This project is aimed at better understanding how children living in agricultural~     environments are exposed to pesticides, and how such exposures can be prevented or reduced.~     The project will develop and implement a community-wide intervention to reduce the transfer~     of pesticides from the workplace to the home (take home pathway).~   "
273105|NCT00013754|"~     This project is aimed at better understanding how children living in agricultural~     environments are exposed to pesticides, and how such exposures can be prevented or reduced.~     The current project will characterize pesticide exposure pathways for children of~     farmworkers.~   "
273106|NCT00013741|"~     The purpose of the study is to examine ways in which a clinical information system can help~     patients better recognize the signs and symptoms of an acute myocardial infarction (heart~     attack) and to take actions to decrease morbidity and mortality that may be related to delay~     in seeking treatment. The software-based intervention will use the best scientific evidence~     to create tailored strategies using a patient's specific health data. This approach is based~     on well-established cognitive and behavioral educational models.~   "
273107|NCT00013728|"~     We are testing the following two hypotheses: 1) Peaks in hourly exposures to airborne~     particulate matter (PM) of outdoor origin will be more closely associated with acute~     asthmatic responses to particles than 24-hour average exposures in susceptible individuals;~     2) Personal exposure to PM, and estimated particle dose to the lungs, will be more closely~     associated with daily asthma severity than standard outdoor particle concentrations measured~     as 24-hour averages at governmental monitoring sites.~   "
273108|NCT00013715|"~     In the U.S., morbidity associated with human rhinovirus (RV) infection represents a major~     health problem. In asthmatics, up to 80% of asthma exacerbations are associated with upper~     respiratory infections. Despite evidence that environmental oxidant pollutants, such as~     ozone, may increase the severity of viral disease, the mechanisms underlying such an effect~     have not been identified. This study will test the hypothesis that exposure of allergic~     asthmatic subjects to ambient levels of ozone directly enhances viral disease by increasing~     infectivity and intensifying virus-induced inflammation.~   "
273109|NCT00013702|"~     This study will evaluate the safety and effectiveness of adding the experimental drug~     adefovir dipivoxil to lamivudine for treating hepatitis B virus (HBV) infection in~     HIV-infected patients with liver cirrhosis. Adefovir inhibits HBV by interfering with~     replication of the virus's genetic material. In some people, the drug has been active against~     strains of HBV that are resistant to lamivudine; it may also have some activity against HIV.~      HIV-infected patients 21 years of age and older with chronic hepatitis B infection and liver~     cirrhosis who have received lamivudine treatment for at least 1 year may be eligible for this~     48-week study. Candidates will be screened with a complete medical history, blood tests and a~     24-hour urine collection. Blood tests include HLA typing (a test of genetic markers on white~     blood cells that permit specialized immunology studies). Within 4 weeks, candidates who~     appear eligible for the study will have a physical examination and medical history, an~     abdominal ultrasound (imaging test using sound waves) to check for cancer of the liver, chest~     X-ray and electrocardiogram (EKG). Blood and urine tests will also be done, and women who can~     become pregnant will have a pregnancy test.~      Patients who meet the study criteria and decide to participate will then start treatment with~     one 10-mg adefovir pill per day by mouth. In addition, patients will continue to take all~     other medications prescribed by their doctor. Follow-up clinic visits will be scheduled as~     follows:~        -  Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for specialized immunology tests and to~          measure blood levels of HIV and HBV.~        -  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine (single sample)~          tests will be done to determine the side effects of adefovir and its effect on the HBV~          infection.~        -  Week 48 or early termination (end of study) - Blood tests (including tests for hepatitis~          C and D), abdominal ultrasound and a 24-hour urine collection to evaluate kidney~          function will be done.~        -  Monthly visits beyond week 48 - Based on the HBV response to treatment and the~          availability of the drug from the sponsor, patients may be offered to extend their~          treatment with adefovir. Those who continue will have monthly follow-up visits for blood~          and urine (single sample) tests.~   "
273119|NCT00013507|"~     This research on Functional Incidental Training ( FIT) primarily involves women residing in~     community nursing homes. It is an individualized rehabilitative protocol intended to improve~     mobility, endurance, strength and continence in frail, older, functionally impaired and~     disabled veterans.~      Objectives of the project are as follows:~      1) Test the effects of FIT on transfer ability, continence, ambulation/mobility, balance and~     fall risk, strength, and endurance; 2) Determine the characteristics of NHCU residents who~     respond to FIT; 3)Identify the most sensitive outcome measures related to FIT; and 4)~     Determine the labor costs of FIT relative to usual care.~   "
273605|NCT00005890|"~     OBJECTIVES:~      I. Examine adrenal cortical function and the incidence of adrenal dysfunction in children~     with septic shock.~      II. Examine the mortality, length of stay in the PICU, and incidence of multiorgan failure in~     children with adrenal dysfunction and septic shock.~   "
273110|NCT00013689|"~     This study will evaluate the safety and effectiveness of an antibiotic called Fansidar on~     autoimmune lymphoproliferative syndrome (ALPS). Patients with ALPS have enlarged lymph~     glands, spleen and/or liver, abnormal blood cell counts and overactive immune function.~     Current treatments are aimed at suppressing the immune system and improving symptoms, such as~     anemia (low red blood cell count) and low white blood cell and platelet counts. These~     treatments, however, are only partially effective and may have complications. Fansidar is a~     combination of two drugs, sulfadoxine and pyrimethamine, that is used to treat or prevent~     parasitic infections such as malaria. Recently a child with ALPS who was treated with~     Fansidar for a different illness had a marked shrinkage of the lymph organs. This study will~     examine whether Fansidar can shrink the lymph glands or spleen in patients with ALPS.~      Patients with ALPS between the ages of 4 and 70 years who have had lymph gland enlargement~     for at least 1 year and are not allergic to sulfa drugs may be eligible for this study.~     Candidates will be screened with a medical history and physical examination and blood tests.~     Females of reproductive age will have a urine pregnancy test.~      Participants will be evaluated at the NIH Clinical Center in Bethesda, MD, with blood tests~     and a computed tomography (CT) scan of the lymph nodes. For the CT scan, the patient lies on~     a table during an X-ray scan of the neck, part of the chest, and, if the spleen has not been~     removed, the stomach area.~      When these baseline tests are completed, patients will be given Fansidar pills to take once a~     week for 12 weeks. The dosage will be increased after 2 weeks and again after 4 weeks. At 2,~     4, 6, 8 and 10 weeks after starting the treatment and 2 weeks after the last dose, patients~     will have blood drawn to check for possible side effects of therapy. Women will have a repeat~     urine pregnancy test at week 6 of treatment.~      Within a week before completing treatment or after completing treatment, patients will return~     to NIH for a history, physical examination, blood tests and CT scan. Patients who responded~     well to treatment will be offered to return to NIH again 3, 6 and 12 months later to repeat~     the evaluations. If ALPS symptoms recur during this time, patients will be offered another~     12-week course of Fansidar and the procedure, including the 3, 6 and 12-month evaluations~     will be repeated again. If symptoms recur again, patients will be asked to resume Fansidar~     for 6 months or longer, with doses adjusted as needed. During this time, patients will be~     seen at NIH every 12 weeks for evaluation and blood will be drawn by the patient's private~     physician every 6 weeks or 2 and 4 weeks after the dose is increased to check for side~     effects.~   "
273111|NCT00013650|"~     The purpose of this study is to evaluate the effects of the drug cyclophosphamide (CY) on~     inflammation and immune responses in individuals with Alzheimer's Disease (AD).~      Inflammation and immunologic response appear to contribute to neurodegeneration in people~     with AD. In a process called gliosis, the brain immune cells microglia and astroglia undergo~     activation and possible proliferation, which promotes neuronal injury and death. Activated~     microglia and astroglia produce compounds that are cytotoxic to neurons, and they express~     molecules that greatly amplify immune and inflammatory processes in the brain. Excessive~     glial activation and proliferation are thought to be pivotal events that hasten the demise of~     synapses and neurons in AD. Fortunately, increased understanding of immune and inflammatory~     pathology in AD has provided new opportunities for designing disease-altering treatments for~     AD. Studies suggest that medications such as nonsteroidal anti-inflammatory drugs (NSAIDs)~     and immunomodulatory agents may have an important role in altering the course of AD. CY is a~     potent anti-inflammatory and immunomodulatory drug that inhibits proliferation of immune~     cells. This study will evaluate the effects of CY on individuals with mild to moderate AD.~      Participants in this study will be randomly assigned to receive either two different doses of~     CY or placebo (an inactive pill) for 6 months. Participants who receive placebo during the 6~     months will have the option of receiving CY for an additional 6 months. Participants will~     undergo magnetic resonance imaging (MRI) scans of the brain. Measures of cerebral spinal~     fluid biomarkers or neurodegeneration, neuroinflammation, and neuroimmune activation will be~     taken. In addition, peripheral lymphocyte subsets and peripheral markers of inflammation will~     be assessed.~   "
273112|NCT00013637|"~     This study's primary objective is to assess the effects of environmental lead exposures and~     genetic risk factors on the development of osteoporosis in middle-aged women.~   "
273113|NCT00013624|"~     This study will evaluate the effects of the drug riluzole on Parkinson's disease symptoms and~     on dyskinesias (involuntary movements) that develop as a result of long-term treatment with~     levodopa. Riluzole blocks the action of the chemical messenger glutamate, thought to be~     involved in producing Parkinson's symptoms. The drug is currently approved to treat~     amyotrophic lateral sclerosis, another neurologic condition.~      Patients with relatively advanced Parkinson's disease between 20 and 80 years of age may be~     eligible for this 4-week study. Participants will have a complete medical history and~     physical examination, and a detailed neurological evaluation. The evaluations will include~     blood tests and an electrocardiogram, and possibly brain magnetic resonance imaging (MRI), CT~     scan, and chest X-ray.~      Participants will, if possible, stop taking all antiparkinsonian medications except levodopa~     (Sinemet) for one month before the study begins and throughout its duration. For the first 1~     to 3 days, patients will be admitted to the NIH Clinical Center to undergo a levodopa~     dose-finding procedure. For this study, patients will stop taking their oral Sinemet and~     instead will have levodopa infused through a vein for up to 8 hours/day. During the~     infusions, the levodopa dose will be increased slowly until either 1) parkinsonian symptoms~     improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached.~     Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than~     what is needed to relieve symptoms (suboptimal rate), and 2) one that relieves symptoms but~     may produce dyskinesias (optimal rate).~      When the dose-finding phase is completed, treatment will begin. Patients will take riluzole~     or placebo (a look-a-like pill with no active ingredient) twice a day, along with their~     regular Sinemet, for 3 weeks. (All participants will receive placebo at some time during the~     study, and some patients will receive only placebo throughout the entire 4 weeks.) At the end~     of each week, patients will be readmitted to the hospital and receive the previous week's~     dose of riluzole or placebo in combination with a levodopa infusion at the rate determined in~     the dose-finding phase of the study. The procedure for the infusion will be the same as that~     for the dose-finding phase. The dose of riluzole will be increased until the optimum dose has~     been achieved or until side effects occur (at which time the dose will be lowered or the drug~     stopped).~      Throughout the study, parkinsonian symptoms and dyskinesias will be evaluated using~     standardized rating scales and blood samples will be drawn periodically to measure drug~     levels.~   "
273114|NCT00013611|"~     This study will examine whether interleukin-2 (IL-2) plus antiretroviral therapy (ART) slows~     HIV disease progression in patients with low CD4+ T cell counts compared with patients taking~     ART alone. CD4+ T cells are a subset of lymphocytes-white blood cells that are part of the~     body's immune system. IL-2 is a protein that is naturally produced by lymphocytes. Given in~     intermittent cycles, IL-2 can raise CD4+ T cell counts in some HIV-infected patients taking~     antiretroviral drugs. This study will examine whether the increase in CD4+ T cells lowers the~     risk of AIDS-related illnesses and death.~      HIV-infected patients 18 years of age and older with a viral load under 10,000 copies per~     milliliter and a CD4+ T cell count between 50 and 299 cells per cubic millimeter who are~     taking antiretroviral therapy and who have not previously received IL-2 therapy may be~     eligible for this study. Candidates will be screened with a medical history, physical~     examination, and blood and urine tests. Participation in the study will be from 4.5 to 6~     years, depending on what point in the duration of the study the individual patient is~     enrolled.~      Patients will be randomly assigned to receive IL-2 plus ART or ART alone. All participants~     will be advised individually about the best ART regimen for them. Patients in the IL-2~     treatment group will be taught how to self-inject IL-2 under the skin (similar to insulin~     injections). They will inject IL-2 twice a day for 5 days every 8 weeks for the first year~     (until week 49 of the study). From week 49 on they may receive 5-day cycles of IL-2 every 4~     months when needed to maintain CD4+ T cell count elevations. An extra cycle may be given 2~     months after the week 49 follow-up visit (see follow-up schedule below), depending on their~     CD4+ T cell count. Patients whose cell counts have not increased after 12 to 16 months of~     IL-2 treatment will discuss with the doctor the possibility of stopping IL-2. Those who do~     stop IL-2 treatment will be asked to remain in the study for follow-up evaluations.~      All patients will be followed in the clinic every 2 months for the first year of the study~     (weeks 1, 9, 17, 25, 33, 41 and 49) and every 4 months during years 2-6 for a brief history~     and physical exam, urine and blood tests, return of diary cards (record of drug side effects)~     and medication review. During the visits from the second year on, patients will also be asked~     about their ability to do certain ordinary tasks, such as taking care of themselves; ...~   "
273115|NCT00013598|"~     This study will evaluate the effectiveness of pioglitazone, a new diabetes medicine, on~     decreasing insulin resistance and improving liver disease in patients with nonalcoholic~     steatohepatitis (NASH). NASH is a chronic liver disease with unknown cause that involves fat~     accumulation and inflammation in the liver, leading to liver cirrhosis in 10 to 15 percent of~     patients and significant liver scarring in another 30 percent. Although similar to a~     condition that affects people who drink excessive amounts of alcohol, NASH occurs in people~     who drink only minimal or no alcohol. It is most often seen in patients with insulin~     resistance. Pioglitazone decreases insulin resistance and improves blood lipid (fat) levels,~     so that it may improve liver disease in NASH.~      Patients with NASH 18 years of age or older may be eligible for this study. Candidates will~     be screened with a medical history and physical examination and routine blood tests. They~     will see a dietitian for counseling on diet and weight reduction, if needed. They will stop~     taking any medications for liver disease and take a daily multivitamin pill. After 2 months,~     those eligible for participation will be enrolled in the study.~      Participants will be admitted to the Clinical Center for 2 to 3 days for a complete medical~     history, physical examination, blood tests, urinalysis, chest X-ray, electrocardiogram,~     abdominal ultrasound and a liver biopsy. After the diagnosis of NASH is confirmed, the~     following procedures will be performed:~        -  Echocardiography - imaging test using sound waves shows the heart structure and function~        -  Resting metabolic rate - measures amount of oxygen (and calories) used to maintain body~          functions at rest. While lying down, the patient wears a clear plastic hood over the~          head for 20 minutes while the amount of oxygen used is measured.~        -  Magnetic resonance imaging (MRI) scans - shows the size of the liver and other organs.~          The patient lies on a table in a metal cylinder that contains a magnetic field (the~          scanner) for no more than 30 minutes while the organs are imaged.~        -  Dual energy X-ray absorptiometry (DEXA) scan measures whole body composition, including~          amount of fat. The patient lies under an X-ray scanning machine for about 2 minutes.~        -  Oral glucose tolerance test (OGTT) - measures blood sugar and insulin levels. The~          patient drinks a very sweet drink containing glucose (sugar), after which blood samples~          are collected at various intervals during the 3-hour test. The blood is drawn through a~          catheter (thin plastic tube) placed in the arm before the test begins.~        -  Intravenous glucose tolerance test (IVGTT) - determines how the tissues respond to~          insulin and glucose. Glucose is injected into a vein, followed by a short infusion of~          insulin. Blood samples are collected through a catheter at various intervals during the~          3-hour test.~      When the above procedures are completed, patients start taking pioglitazone by mouth once a~     day for 48 weeks, keeping track of the medication and any side effects. They will be seen at~     the clinic every 2 weeks for the first month and then every 4 weeks for the rest of the~     treatment period. The visits will include an interview and examination by a physician and~     blood draw for laboratory tests. Female patients will have a pregnancy test at each clinic~     visit. At the end of the treatment period patients will be admitted to the Clinical Center~     for a repeat medical evaluation that will include the procedures described above.~   "
273116|NCT00013559|"~     This study will examine how a rare disease called Smith-Magenis syndrome (SMS) affects people~     and how they change over time. SMS is caused by a small chromosome 17p11.2 deletion (missing~     piece). The syndrome is associated with distinct physical, developmental and behavioral~     characteristics, but it is not fully understood. To learn more about this disease, a~     multidisciplinary research team will study:~        -  The range and type of medical, behavioral, and learning problems of people with SMS~        -  The deletion of chromosome 17p11.2 to find the gene or genes that cause SMS~        -  Whether certain specific genetic changes cause certain specific medical problems~        -  What signs and symptoms must be present to make a diagnosis of SMS~        -  The impact that a child with SMS has on his or her family members.~      Patients of all ages with SMS may be eligible for this study. They will be evaluated by a~     team of medical specialists at the NIH Clinical Center over the course of several days.~     Parents of patients will be asked to provide copies of past medical records and tests results~     for review. They will provide a family medical history and information on the child s~     prenatal, developmental, behavioral and medical histories.~      The study may involve the following evaluations: physical, neurological and psychological~     exams; ear, nose and throat evaluation; speech, language and swallowing evaluation; hearing~     test; eye examination; imaging studies (e.g., X-rays, ultrasound, MRI); developmental and~     behavioral assessment; rehabilitation evaluation with gait (walking) analysis; urinalysis,~     blood, and/or skin cell studies; sleep study; other consultations as required. A tissue~     sample (blood or cheek swab or skin biopsy) may be taken for genetic studies. To obtain a~     cheek swab, a small brush is rubbed against the inside of the cheek to wipe off some cells.~     For a skin biopsy, a small area of skin is numbed with a local anesthetic and a small circle~     of skin, usually about 1/8 inch, is removed with a biopsy tool. Parents may be asked to~     complete questionnaires about their child s growth and development, therapies, medications,~     sleep, development and behavioral concerns. They also may be asked to bring their child to~     NIH for follow-up visits every 6 months to 3 years, depending on the child s age. The purpose~     of these visits is to see how the child changes over time and to conduct additional tests.~      Parents may also be asked to enroll their child in a SMS Research Registry and provide tissue~     samples for a SMS Research Core Tissue Bank. The research registry is a confidential database~     of individuals diagnosed with SMS. Its purpose is to facilitate SMS research initiatives and~     promote the development of improved treatments for SMS. Enrollment requires completing a~     30-minute questionnaire. The tissue bank stores tissue cultures and cell lines created for~     future SMS research. About 2 teaspoons of blood are drawn from adult patients and 1 to 3~     teaspoons from children, depending on their size. Tissue samples can be obtained by skin~     biopsy or during a scheduled surgical procedure.~   "
273117|NCT00013546|"~     This study will evaluate the effects of hormone replacement therapy on patients with Turner~     syndrome (TS)-a genetic disorder in females in which part or all of one X chromosome is~     missing. Most girls and women with TS have underdeveloped ovaries-the female reproductive~     organs that produce the female sex hormones estrogen and progesterone, and smaller amounts of~     the male sex hormone, testosterone. These hormones affect muscle and bone strength, sex~     drive, energy, and an overall sense of well being. Estrogen may also play a role in memory~     and mood and have a protective effect against heart disease. Women with TS have a much higher~     risk of developing osteoporosis (loss of bone density), high blood pressure, high cholesterol~     and diabetes than women without this disorder.~      Girls and women with Turner syndrome between the ages of 14 and 50 years may be eligible for~     this 2-year study. Three months before beginning treatment, all patients will wear an~     estrogen patch and take a progesterone tablet daily for 10 days each month. They will then be~     randomly assigned to one of two treatment groups to compare the effects of estrogen alone~     with estrogen plus testosterone on bone strength, muscle and fat mass and psychosocial well~     being. Both groups will wear an estrogen patch and take oral progesterone. One group will~     also wear a testosterone patch while the other group will wear a placebo patch (a patch that~     does not contain any testosterone). Neither study participants nor the doctors will know who~     is getting the testosterone until the study is complete. Patients will undergo the following~     procedures before beginning treatment and at 6, 12 and 24 months after starting treatment:~        -  Physical examination.~        -  DEXA scans (dual energy X-ray absorptiometry) to measure body composition and bone~          thickness. Low radiation X-rays scan the whole body to measure fat, muscle and bone~          mineral content..~        -  Magnetic resonance imaging (MRI) scan of the abdomen to measure the amount of fat around~          the internal organs. The patient lies on a stretcher in a large tube surrounded by a~          magnetic field during the scanning. The procedure uses a strong magnet and radio waves~          to produce the images.~        -  Heel ultrasound to measure bone thickness. The heel is placed in a chamber and sound~          waves pass through it to produce images.~        -  Oral glucose tolerance test (OGTT) for diabetes and problems with carbohydrate~          metabolism. The patient drinks a sugary substance. A small amount of blood is drawn~          before taking the drink and four times afterwards.~        -  Blood and urine tests to measure blood counts, liver and kidney function, ovarian~          hormones, growth factors, thyroid function, blood lipids, bone strength markers, and to~          test for pregnancy.~        -  Blood pressure measurements.~        -  Psychological testing for the effect of treatment on mood, self-esteem, quality of life,~          social shyness, anxiety and sexual function.~        -  Neurocognitive tests (at first inpatient visit and 1 and 2 years after starting~          treatment) to measure nonverbal memory and visual-perceptual abilities.~      During the hospital admissions, patients will be given a metabolic diet that contains~     specific amounts of salt and carbohydrates to ensure accurate blood pressure and sugar~     metabolism measurements. Patients will keep a record of their menstrual periods and physical~     activity throughout the treatment period.~   "
273118|NCT00013533|"~     Background:~        -  Allogeneic blood and marrow stem cell transplantation (BMT) plays an important role in~          the curative treatment of a number of pediatric malignancies. Unfortunately, the success~          of conventional allogeneic BMT is limited in part by the multiple toxicities associated~          with myeloablative preparative regimens.~        -  Non-myeloablative pre-transplant regimens are associated with less toxic side effects~          than standard BMT. Recently, a novel immunosuppressive, non-myeloablative pre-transplant~          chemotherapy regimen has been shown to facilitate complete donor engraftment in an adult~          trial at the NCI.~      Objectives:~      The primary objective of this protocol is to evaluate the efficacy and safety of this~     treatment approach in pediatric patients with hematopoietic malignancies~      Eligibility:~      Inclusion Criteria~      Age: Patient must be greater than or equal to 5 years and less than 22 years of age.~      Diagnosis:~        -  Hodgkin s and Non-Hodgkin s Lymphoma: Refractory disease or relapse after salvage~          regimen.~        -  Acute Myelogenous Leukemia: History of bone marrow relapse in remission (CR) #2 or~          greater.~        -  Acute Lymphocytic Leukemia: History of bone marrow relapse in CR #2 or greater (CR#1~          with Philadelphia chromosome positive or prior induction failure).~        -  Acute Hybrid Leukemia including mixed lineage, biphenotypic and undifferentiated:~          History of bone marrow relapse in CR #2 or greater (CR#1 with Philadelphia chromosome~          positive or prior induction failure).~        -  Myelodysplastic Syndrome: RAEB or RAEB-t with less than 10% blasts in marrow and blood.~        -  Chronic Myelogenous Leukemia: Chronic phase or accelerated phase with less than 10%~          blasts in marrow and blood.~        -  Juvenile Myelomonocytic Leukemia: less than 10% blasts in marrow and blood.~      Prior Therapy: Chemotherapy to achieve above criteria allowed. Prior BMT allowed as long as~     at least day 100+ post-prior BMT, no evidence of GVHD, and no detectable residual donor~     chimerism.~      Donor: First degree related donors, who are HLA matched (single HLA-A or B locus mismatch~     allowed), weight greater than or equal to 15 kilograms, and who meet standard donation~     criteria will be considered. The same donor from a prior BMT is allowed.~      ECOG Performance Status: 0, 1, or 2. and life expectancy: greater than 3 months.~      Liver Function: Serum direct bilirubin less than 2.0 mg/dL and serum ALT and AST values less~     than or equal to 2.5x upper limit of normal. (Values above these levels may be accepted if~     due to malignancy.)~      Renal Function: Age adjusted normal serum creatinine or Cr clearance greater than or equal to~     60 mL/min/1.73 m(2).~      Pulmonary Function: DLCO greater than or equal to 50%.~      Cardiac Function: LVEF greater than or equal to 45% by MUGA or LVSF greater than or equal to~     28% by ECHO~      Exclusion Criteria~        -  Active CNS malignancy: Tumor mass on CT or leptomeningeal disease. (Patients with a~          history of CNS involvement and no current evidence of CNS disease are allowed.)~        -  HIV infection, active hepatitis B or C infection: HbSAg or HCV seropositive and elevated~          liver transaminases.~        -  Fanconi Anemia.~        -  Lactating or pregnant females.~      Design:~      Pilot Study~        -  Initial evaluation: Patient and donor will be screened for eligibility. G-CSF primed~          bone marrow derived stem cells will be collected from the donor.~        -  Induction/Consolidation chemotherapy: 1 to 3 cycles will be given every 22 days~          depending on disease response, CD4 count, and toxicities.~        -  Lymphoma: fludarabine, etoposide, doxorubicin, vincristine, cyclophohamide, prednisone,~          and filgrastim (EPOCH-fludarabine).~        -  Leukemia and MDS: Fludarabine, cytarabine, and filgrastim (FLAG).~        -  Transplantation: Fludarabine and cyclophosphamide will be administered over 4 days~          followed by bone marrow transplant. Patients will remain hospitalized until bone marrow~          recovery. Patients will be monitored closely at the NIH for at least 100 days post-BMT.~        -  Post-transplant CNS prophylaxis for ALL: Standard post-transplant CNS prophylaxis will~          be employed with intrathecal methotrexate to decrease the risk of CNS relapse for all~          patients with ALL.~        -  Total number of recipient and donors to be accrued is 56.~   "
273951|NCT00005321|"~     To address the public health importance of sleep disordered breathing and ultimately reduce~     morbidity through information gained from longitudinal, population-based, epidemiologic~     studies.~   "
273120|NCT00013494|"~     For hemiplegic, stroke patients wheelchair transfers is a critical, safety-related area of~     physical function.~      This project will develop a personalized training and clinical assessment instrument based on~     the Video-Based F-PAT (Functional Performance Assessment and Training.) The objectives of the~     study are: (1) Enhance the pilot F-PAT web site to allow clinicians password-protected access~     to the digitized video and assessment information; and (2) train an Occupational Therapist~     collaborator to create the personalized videotapes for patients to take home with them. This~     study has the dual goal of evaluating the effectiveness of the personalized training~     videotapes and the effectiveness of the video-based assessment methodology.~   "
273121|NCT00013481|"~     This study will determine whether a therapeutic exercise program for improving motor~     coordination in locomotor tasks in post-stroke, hemiparesis patients will result in CNS~     recovery. The study will develop relationships between the improved motor performance and~     motor coordination during the locomotor task and the functional effects of the exercise~     program(e.g., gait variables.)~   "
273122|NCT00013468|"~     Tinnitus is a prevalent issue for veterans who are proportionally more hearing-impaired than~     the civilian population.~      This study will be conducted as three concurrent projects designed to develop an efficient~     clinical technique to quantify tinnitus perception:~      (1)Laboratory development of the automated technique for comprehensive tinnitus~     quantification;(2)Development of a technique to test for tinnitus malingering; and~     (3)Evaluation of the automated technique in the clinical environment.~   "
273123|NCT00013455|"~     The purpose of this study is to examine and relate physiological, behavioral, and~     self-perceived changes after a period of hearing aid use and as a function of auditory~     training. The project will focus on the following questions: 1)Is experience-related~     behavioral change in hearing aid performance reflected as a neurophysiologic change? 2)Does a~     neurophysiologic change occur prior to or in conjunction with an experience-related~     behavioral change? 3) Does behavioral training modify the neurophysiologic representation of~     speech following the provision of hearing aids? 4)What is the relationship between~     physiologic, behavioral,and self-perceived change impacted by behavioral training? 5)Are~     neurophysiologic changes limited to trained stimuli or does auditory training alter~     neurophysiological responses?~   "
273124|NCT00013442|"~     Over one million persons in the United States are aphasic subsequent to a stroke. Most of the~     individuals improve through spontaneous recovery and treatment. However, there are no precise~     methods for predicting which patients will improve and, for those who do, how much~     improvement will occur. There is a need to improve prognostic precision in aphasia. The~     purpose of this investigation is to test the precision of auditory evoked responses (AERs) to~     provide a prognosis for improvement in aphasia subsequent to a left hemisphere thromboembolic~     infarct. We hypothesize that the presence, absence, and pattern of the AER responses will~     predict severity of aphasia and prognosis for improvement. Phonemic, phonologic, semantic,~     and syntactic language tasks will be used to elicit AERs, including the auditory late~     response, the mismatch negativity response (MMN), the N400, and the P600.~   "
273125|NCT00013429|"~     The project objective is to validate the types of eye trackers that may most effectively be~     employed in the rehabilitation evaluation and training of people with central scotomas. The~     eye trackers will include the three basic types of eye trackers, namely, 1)electrophysical,~     2) front surface trackers, and 3) retinal trackers.~   "
273126|NCT00013416|"~     The long-term goal of this research program is to develop methods to predict both the benefit~     and the satisfaction that hearing-impaired patients will derive from auditory amplification~     in daily life. This proposal has three primary objectives: (1) To determine the influence of~     extra-audiological variables, such as personality attributes and expectations, on the~     subjective outcomes of hearing aid fittings, (2) To establish a scientific basis for~     selection, administration, and interpretation of self-report measures of hearing aid fitting~     outcome, (3) To resolve the long-standing debate about the efficacy of using clinically~     measured loudness perception data in hearing aid prescriptions.~   "
273127|NCT00013403|"~     The project has four primary objectives: 1) Determine if blind rehabilitation improves the~     quality of life of legally blind veterans; 2) Determine the relationship between quality of~     life and visual function; 3) Determine if factors, such as cognitive status, level of~     depression, age and the presence of additional medical conditions besides vision loss,~     intervention of blind rehabilitation extends beyond the visually impaired individual and~     improve the quality of life of their primary caregiver (e.g. spouse, partner, family member~     or friend.)~   "
273128|NCT00013390|"~     The investigators propose to evaluate two different approaches to the alleviation of tinnitus~     symptoms by comparing changes from baseline performance on the Tinnitus Severity Index. They~     propose to provide an unbiased evaluation of competing methodologies. The design is one in~     which pairs of prospective subjects are randomly assigned to one of two treatment groups.~     Changes in group performance will be compared for selected measures.~   "
273129|NCT00013377|"~     There are two diseases in particular that may have serious consequences for driving and~     mobility due to their potentially severe impact on visual function: glaucoma and diabetic~     neuropathy. In this project we will develop predictive models of driving for these patients~     and will train them to use low-vision aids to improve driving mobility. We will determine how~     best to train patients with hemianopic field loss due to cerebral vascular accidents and~     identify predictors of long-term success in the use of low-vision aids.~   "
273130|NCT00013364|"~     The effects of talker variability will be investigated with four groups of listeners (young~     normal-hearing; old normal-hearing; young hearing-impaired; old hearing-impaired).~     Experimental conditions will include between-talker differences, speaking rate, lexical~     difficult and semantic/linguistic context. A preliminary experiment will evaluate the~     relative merit of adaptive vs fixed-level methods of stimulus presentation.~   "
273144|NCT00013182|"~     Sleep-activity rhythm disturbance is a prevalent, disabling symptom in cognitively-impaired~     (CI) elders. Their nocturnal sleep is light and inefficient with frequent awakenings.~     Multiple short daytime napping episodes interfere with daytime activity and functioning.~     Daytime disruptive behaviors, such as pacing, hitting, and cursing are related significantly~     to sleep-activity rhythm disturbance. Medical treatment for sleep and behavior disturbances~     with benzodiazepines or antipsychotic medications has proven minimally effective and has~     serious side effects such as impairments in cognition, memory, coordination, and balance,~     tolerance and severe rebound insomnia, and tardive dyskinesia.~   "
273131|NCT00013351|"~     The relationship between Useful Field of Vision (UFOV) and falls taken by the elderly will be~     investigated. UFOV is a test which measures visual attention. The test has been used in~     correlating the visual attention in the elderly with their driving safety record. The test is~     administered using a computer and consists of three parts: a) subject views figures which~     appear in the center of the computer screen and identified them as quickly as possible; b)the~     subject has to identify figures in the center of the screen while at the same time point to~     another symbol which will appear in one of eight places on the outer portion of the screen;~     c) the third section is similar to the second except while the subject is identifying and~     pointing there is a background noise.~   "
273132|NCT00013338|"~     This is a randomized, controlled trial to compare supported treadmill ambulation training~     (STAT) to conventional gait training for improving gait speed, gait endurance, gait~     efficiency and muscle function in SCI subjects injured more than six months prior to start of~     training. Each subject will receive twelve weeks of either CGT or STAT, given as 20 minutes~     of training within a one-hour period per day, five days per week. These subjects will be~     studied baseline, 4,8 and 12 weeks of training, and three months after the end of training~     with a battery of tests designed to evaluate the subjects' gait and muscle function.~   "
273133|NCT00013325|"~     The purpose of this three-year study is to determine the prevalence and incidence of the~     different types of cardiac disease and ECG abnormalities in SCI patients. Study goals are:~     (i) delineation of the specific types of heart disease that occur in the SCI population as~     manifested both pre-clinically and clinically and (ii) demonstration of their association~     with ECG findings. This will enable validation of scores and algorithms using the inexpensive~     and widely available ECG for the prevention of heart disease as well as it's early treatment~     and rehabilitation in SCI patients.~      The findings will be helpful in demonstrating what cardiological tests are appropriate for~     the mandated annual evaluation of SCI patients.~   "
273134|NCT00013312|"~     This study will compare individuals with acute SCI to control patients in order to: 1.~     Determine if there are changes in colonic tone and sensation after SCI by comparing the~     fasting responses to the postprandial responses; 2. Determine if there are changes in colonic~     phasic motility after SCI by comparing the fasting responses to the postprandial responses;~     3. Determine if colonic motor and sensory function after SCI change over time by repeating~     these studies six month later in SCI and control patients.~   "
273135|NCT00013299|"~     This is a randomized clinical trial to: (1) Determine the extent to which custom made study~     shoes will reduce the incidence of reulceration in diabetic individuals with prior history of~     foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.~   "
273136|NCT00013286|"~     This project will identify risk factors for diabetic foot ulcer by studying the relationship~     between endothelial dysfunction and foot ulcer risk. A fundamental defect in type 1 and 2~     diabetic subjects is impaired vasodilatory reserve which is reflected in the dysfunction of~     endothelium-dependent vasodilation. Findings thus far point to an important role of the~     microvasculature in the development of diabetic foot ulcer and amputation.~      In this study a a well-characterized cohort of 750 diabetic veterans without foot ulcer will~     be followed over 3-years.~   "
273137|NCT00013273|"~     The purpose of this research is to evaluate the efficacy of a structured program of physical~     therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). The~     study will also investigate the interrelationship among measure of chronic venous diseases:~     lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of~     life. Sixty patients will be randomized to a 6 months physical therapy program or to a~     control group.~   "
273138|NCT00013260|"~     Managed care systems rely on primary care providers as gatekeepers to make sensible decisions~     regarding the use of expensive health care resources. While this model has some intuitive~     appeal in terms of its potential for decreasing health care costs, it may not be applicable~     in VA medical centers, where patients are often medically complex and socioeconomically~     vulnerable. Thus, other strategies to integrate generalist and specialist care are required.~   "
273139|NCT00013247|"~     Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most~     authorities recommend that providers inform and involve patients in CaP screening decisions.~   "
273140|NCT00013234|"~     We have previously shown (IIR 95-045) that teledermatology, using store and forward~     technology, can result in reliable and accurate diagnostic outcomes when compared to~     clinic-based dermatology consultations. This investigation builds on that fundamental~     diagnostic information by assessing the health services implications of a teledermatology~     consult system.~   "
273141|NCT00013221|"~     Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in~     clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead~     to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning~     and deterioration of muscle function. Until recently, the prescription for individuals with~     HF was rest and minimization of physical exertion.~   "
273142|NCT00013208|"~     Despite a growing array of therapeutic options and efficacious treatment strategies to~     prevent or delay some of the most severe complications of type 2 diabetes, there continue to~     be many individuals with outcomes that are far from optimal. Interventions to improve~     diabetes care by educating providers and patients have been disappointing. In the past~     several years, case management has been widely advocated as a cost-effective approach to~     coordinate diabetes care and improve outcomes, although there is little rigorous evidence~     demonstrating the benefits of this type of intervention.~   "
273143|NCT00013195|"~     Many elderly primary care patients are at high risk for health complications and functional~     impairment due to low levels of physical activity. Previous trials of counseling of elderly~     patients in primary care clinics have not demonstrated lasting physical activity change and~     have not evaluated fitness changes associated with any increased activity.~   "
273145|NCT00013169|"~     A variety of models of psychiatric hospital alternative care have been developed over the~     past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one~     of the best established of these alternatives, comprising a network of 6 facilities with a~     total of 77 beds. Although veterans have been among those served at START programs for many~     years, no previous study of START or any other model has focused specifically on veterans.~   "
273149|NCT00013117|"~     The goal of this research was to determine if providing specialist input to primary care~     providers (PCPs) by means of informal consultation could improve the process and outcomes of~     care for diabetes. Several studies support the role for specialists and their specific~     knowledge and expertise in a variety of disorders including diabetes. A variety of methods~     have been designed to optimize the use of specialty expertise including practice guidelines~     and disease management approaches as well as the consultation/referral process. The~     referral-consultation process is an important mechanism for obtaining clinically useful~     information. At one end of the spectrum of this process, informal consultation involves~     discussion about a patient with a colleague without the consultant seeing the patient; at the~     other end of the spectrum, care of the patient is transferred to another physician and the~     process is formalized. Because much specialist expertise resides in the specialists~     themselves, the expansion of primary care sites to include community-based outpatient clinics~     has implications for access to the specialists located elsewhere. This study was designed to~     evaluate a computer-assisted voice mail system which is relatively inexpensive and more~     convenient than video-telemedicine systems, making it more practical and more easily~     exportable. Diabetes care delivery was chosen as the model in which to assess informal~     consultation based on its frequency among veterans, management challenges, and the emphasis~     on improvement in diabetes care in VA. A secondary goal of the project was to better~     characterize the consultation process.~   "
273150|NCT00013104|"~     The purpose of this study is to design and evaluate targeted implementation strategies to~     fully integrate the VHA clinical practice guidelines for ischemic heart disease into VHA~     clinical practice. Effectively implementing the guideline will enhance the quality,~     appropriateness, timeliness, and cost effectiveness of care delivered to veterans with~     ischemic heart disease.~   "
273151|NCT00013091|"~     Post-traumatic stress disorder is a mental health problem of enormous proportion within the~     VA system for both male and female veterans. The 40 percent of veterans with PTSD and~     concurrent clinically significant depression are particularly difficult to treat. Effective~     and efficient treatment of veterans with this combination of disorders would be of benefit to~     a significant number of veterans.~   "
273152|NCT00013078|"~     Falls are the leading cause of nonfatal injuries in the United States and the second leading~     cause of all unintentional injury deaths. Each year fractures of the hip account for about~     200,000 hospitalizations among the elderly and falls are contributing factors in 40 percent~     of admissions to nursing homes. About 30 percent of community-dwelling elderly fall each~     year, with about 10 percent seeking emergency medical help for a fall injury. Data from~     CDC-funded study to assess falls among the elderly (SAFE) suggest that as many as 41 percent~     of elderly patients fall at home in the year following discharge from hospitalization due in~     part to deconditioning associated with inactivity.~   "
273153|NCT00013065|"~     It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To~     benefit from recent improvements in anti-HIV therapy, patients need to take their medications~     consistently.~   "
273154|NCT00013052|"~     Control of the blood sugar prevents complications and results in extra years of life in~     patients with diabetes. Practice Guidelines delineating specific ways physicians manage~     diabetes have been outlined. Missing are guidelines for health care providers to encourage~     patients to take responsibility for their diabetes. Traditional patient education models have~     been ineffective in managing diabetic persons because they have relied upon information given~     alone and are disease centered rather than patient centered. This study will explore the role~     of self-efficacy in helping veterans move toward healthy behaviors.~   "
273155|NCT00013039|"~     Physician compliance with practice guidelines is imperfect. Computer-generated reminders from~     electronic medical record systems have been shown to increase compliance with guidelines, but~     they often require symptom and history data, which limits computer facilitation. Heart~     failure is a serious condition for which compliance with established guidelines is~     suboptimal. Physicians� compliance with heart failure guidelines may improve if such~     reminders use symptom and history data.~   "
273156|NCT00013026|"~     Congestive heart failure is a serious health problem in the United States and is associated~     with excessive morbidity and mortality. Several classes of medications have been shown to~     improve mortality in patients with CHF. Despite this these medications are widely under~     prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on~     the management of CHF have been published. Implementation of guidelines is challenging and~     most strategies have focused on changing physician behavior. Patient-based interventions have~     been shown to be effective in implementing guidelines on CHF but they have been very labor~     intensive. A computer based intervention to implement CHF guidelines, if effective, would be~     beneficial.~   "
273157|NCT00013013|"~     Among veterans, smoking is the single most important risk factor for preventable mortality~     and morbidity, and studies suggest a higher prevalence of smoking among veterans than the~     general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking~     Cessation, yet most hospitals have poorly developed smoking cessation programs.~   "
273158|NCT00013000|"~     Schizophrenia, a chronic psychiatric disorder, is the second most frequent VA discharge~     diagnosis. Medication management practices for schizophrenia often are not~     guideline-concordant and place patients at risk for adverse outcomes. This project tests a~     new strategy to standard implementation for VHA Schizophrenia Guidelines.~   "
273159|NCT00012987|"~     Smoking is a serious and common health risk among veterans. Given the press of national~     initiatives and local incentives to improve smoking cessation care in response to VA~     performance measures, this study tests a widely applicable approach to clinical practice~     guidelines implementation, namely evidence-based quality improvement, which is directly~     relevant to the translation of efficacious treatments into enhancements in VA health care~     policy and practice. Evidence-Based Quality Improvement (EBQI) focuses on improved provider~     adherence to smoking cessation guidelines and a decrease in patient smoking rates in a manner~     designed to produce short- and long-term health improvements and cost benefits at the~     organizational level.~   "
273160|NCT00012974|"~     The purpose of this study is to examine the efficacy of telephone-administered~     cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by~     community-based outpatient clinics (CBOCs) in the Veteran�s Integrated Service Network (VISN)~     21, which serves rural areas in Northern California~   "
273162|NCT00012948|"~     Smoking cessation interventions including behavioral and pharmacological components have been~     demonstrated to be both effective and cost-effective. Although there is a high prevalence of~     smoking and smoking-related disorders among veterans who use VA medical centers for health~     care, rates of identification of tobacco use and provision of brief and/or intensive smoking~     cessation services are suboptimal. Telephone outreach (TO) may serve to increase access to~     counseling and medications to assist smoking cessation. From the standpoint of health~     systems, TO provides the opportunity for centralized oversight and quality assurance, economy~     of scale, and dissemination strategies that are practical to implement. At the provider~     level, TO addresses barriers to delivery of services such as limited time and skills. From~     the standpoint of the smoker, attractions of TO include accessibility, convenience, and~     privacy.~   "
273163|NCT00012935|"~     Newly diagnosed localized prostate cancer patients face difficult decisions about treatment~     and management; including radiation therapy, radical prostatectomy, brachytherapy, and~     observation. Previous studies have cited patient preference and physician recommendation for~     treatment as major roles in treatment decisions.~   "
273164|NCT00012922|"~     Of 17 performance measures of hospital quality regularly reported for the Veterans~     Administration (VA) health care system, rates of colorectal cancer screening are the lowest.~   "
273165|NCT00012909|"~     The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT)~     is complex because patients must balance the short and long-term risks and benefits.~     Information from new and important clinical trials must also be considered. The purpose of~     this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in~     improving the decision making process for women considering the use of estrogen HT.~   "
273166|NCT00012896|"~     Cancer pain is a pervasive problem for the person with cancer. Despite advances in knowledge,~     effective cancer management is infrequently achieved. While this problem is multi-factorial,~     the patient may have attitudinal barriers to effective pain management that can be~     ameliorated with novel interventions.~   "
273167|NCT00012883|"~     Heart failure is a major public health burden in the United States characterized by increased~     morbidity and mortality, and reduce exercise capacity with distressing symptoms of dyspnea~     and fatigue. Evaluating the effects of complementary intervention (such as exercise training)~     on functional status and QOL are clinically important and relevant to HF patients.~      In the last decade, hospital-based and a home bicycle exercise programs for HF have been~     shown to improve peak oxygen consumption (VO2) and symptom scores, and restore autonomic~     balance. These programs may be costly for patients to perform. Improved peak VO2 may not~     necessarily translate into improved functional status and quality of life. To date, the~     effects of a home walking exercise program alone on functional status, QOL and autonomic tone~     has not been evaluated.~   "
273168|NCT00012870|"~     Nurses play an important role in helping patients to manage symptoms, adhere to treatment,~     and change behavior. There has been a lack of research regarding nonpharmacologic~     interventions with patients with heart failure and other chronic conditions.~   "
273169|NCT00012857|"~     Dementia illness often co-exists with painful medical conditions associated with aging (e.g.,~     degenerative joint disease, osteoarthritis, skin ulcers, back pain, headaches, cancer, or~     angina). While the standard practice is pain assessment for all patients, the elderly with~     dementia have special needs for assessment, management, and evaluation. When they are unable~     to verbalize pain, objective measurement of their discomfort are possible manifestations of~     pain. No research relates systemic pain treatment with reduction of negative problematic~     behaviors in patient dementia.~   "
273170|NCT00012844|"~     This study is one of several initiated by the investigators to reduce musculoskeletal~     injuries in patient care providers. Nurses have one of the highest incidences of work related~     back injuries of any profession. Over the past 20 years, efforts to reduce work-related~     injuries in nursing have been largely unsuccessful.~   "
273171|NCT00012831|"~     This study evaluates the effectiveness of a nurse-managed interdisciplinary (nursing and~     occupational therapy) clinic serving community dwelling dementia patients and their spouse~     caregivers. It is grounded in a nursing self-care model that guides nurses to identify~     interventions that fit with the capabilities of individual patients and compensate for their~     specific deficits. The occupational therapy assessment uses the Allen Cognitive Levels that~     identify the abilities and deficits of a particular functional level so that the strategies~     and approaches taught to caregivers can be tailored to the specific needs of the patient.~   "
273172|NCT00012818|"~     Despite the development of significant pharmaceutical treatments, morbidity and mortality of~     chronic heart failure (CHF) patients remain high, patients� quality of life is poor, and~     their health care utilization is heavy. It is therefore important to find a cost effective~     non-pharmaceutical treatment to help CHF patients manage the disease. The relaxation response~     has been found to be effective in managing CHF-related conditions. With its favorable~     physiological changes, the relaxation response is likely to benefit CHF patients.~   "
273173|NCT00012805|"~     Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses~     among veterans in the adult population, and accounts for substantial morbidity and mortality~     in this population. Interventions that enhance symptom self-monitoring and increase~     understanding of COPD therapy may lead to earlier detection of clinical deterioration~     permitting more timely intervention by health care providers. However, such interventions are~     labor-intensive and expensive, and typically require patients to go to a medical facility on~     a regular basis. A novel means of providing such interventions is a Telephone-Linked Computer~     (TLC) system, a computer-based telecommunications system that can monitor, educate, and~     counsel patients through regular automated conversations in patients� homes. In previous~     studies, we have demonstrated the applicability of TLC technology in the clinical monitoring~     of adults with chronic disease conditions such as hypertension and hypercholesterolemia.~   "
273217|NCT00011609|"~     The primary purpose of this project, is to evaluate the effect of a wheelchair mounted~     robotic arm (WMRA) to improve the functional independence of veterans with SCI.~      The study will determine if the ability to perform marker tasks within the following four~     categories is improved after the 4 week training period using the robotic arm:~      1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific~     tasks.~   "
273174|NCT00012792|"~     Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses in~     the adult population and accounts for approximately 25,000 discharges from VA hospitals in a~     calendar year. In addition to the burden put on the health care system, COPD is a disabling~     condition that adversely affects functional status and quality of life (QOL). Several reports~     have suggested that exercise training programs can reduce the frequency of hospitalization~     for COPD; however, these reports have important methodological limitations and such programs~     have not been widely implemented in the VA health care system. Although the underlying lung~     pathology of COPD may be unalterable, physical reconditioning has been clearly demonstrated~     to improve cardiorespiratory status in COPD patients. These physiologic changes have the~     potential to substantially improve QOL and reduce functional disability. Moreover, improved~     cardiorespiratory reserve may decrease the utilization of health care resources during mild~     to moderate exacerbation of COPD.~   "
273175|NCT00012779|"~     This study was designed to assess the effectiveness of a Health Education Program (HEP) for~     improving the well-being and reducing the health care use and cost of care of frail older~     outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a~     multi-component group program delivered in 8 weekly, 2-hour sessions, and 10 monthly 2-hour~     follow-up sessions, it includes emotion-focused and problem focused coping strategies,~     education and support.~   "
273176|NCT00012766|"~     Most depression treatment takes place in primary care, where the condition continues to be~     under-detected and under-treated. A collaborative care model derived from chronic illness~     management theory has been successful in improving care in other managed care settings.~   "
273177|NCT00012753|"~     Regular outpatient follow-up is important for all diabetes patients, with some needing~     frequent attention because their health is unstable, their treatment regimen is complex, or~     their social supports are inadequate. However, many patients live with access barriers that~     limit their use of outpatient services, fail to attend outpatient appointments, and~     experience worse outcomes than trials of aggressive management suggest is possible. Although~     labor-intensive, telephone care programs are one potential strategy for bringing diabetes~     management services into patients� homes and improving their glycemic control. Automated~     telephone disease management (ATDM) systems can augment telephone care by providing frequent~     monitoring and health education to large patient panels while focusing clinicians� attention~     on individuals who need it most. Although this technology has shown some promise, it has not~     been rigorously evaluated, particularly in VA.~   "
273178|NCT00012740|"~     Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many~     innovative geriatric care programs exist within VHA, we still lack a systematic process for~     identifying at-risk elders from the larger VA population who are likely to benefit from~     specialized geriatric services.~   "
273179|NCT00012727|"~     This project�s goal is to improve the quality of care and reduce treatment costs for veterans~     with substance abuse and psychiatric problems.~   "
273180|NCT00012714|"~     Prior rehabilitation outcome studies had many weaknesses. They had: a) evaluated~     rehabilitation effects only in isolated subgroups, b) focused on functional ability rather~     than on quality of life, c) not used randomized control groups, and d) had inadequate sample~     sizes. Differences in methodological approaches have resulted in inconsistent findings. The~     lack of long-term benefits suggests that services may need to be continued at home or in~     subacute care settings to optimize their effectiveness. Unfortunately, prior research did not~     include behavioral outcomes. The potential benefits of rehabilitative care could thus not be~     evaluated by these studies in more meaningful detail, and they did not accurately reflect the~     psychosocial objectives of rehabilitation.~   "
273181|NCT00012701|"~     The VA is the largest single provider of HIV care in the United States. The late 1990's have~     seen a revolution in the quality standards for this disease with the onset of Highly Active~     Antiretroviral Therapy (HAART) and other developments.~   "
273182|NCT00012688|"~     Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care~     include the prevention and/or delay of complications via adequate glycemic control.~     Improvements in periodontal status may also improve diabetes control.~   "
273183|NCT00012675|"~     Many patients with diabetes are under sub-optimal glycemic control. Central to the~     clinician's task in improving glycemic control is the management of hypoglycemic medication~     therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have~     demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic~     control. Yet quality measures for this critical process of care have not been developed and~     we know little about how physicians actually manage hypoglycemic medications.~   "
273184|NCT00012662|"~     Social, medical and economic burdens of diabetes care result from microvascular,~     macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce~     the incidence of these complications by as much as 50 percent. Studies have demonstrated~     improved glycemic control with nurse case-management or educational care models. However,~     none have controlled for their independent contributions, intervened with advanced practice~     nurses (APN), or targeted highest risk individuals.~   "
273185|NCT00012649|"~     The purpose of this study is to improve the quality of VA diabetes care using an automated~     telephone disease management (ATDM) system that administers patient assessments and targeted~     self-care education between clinic visits.~   "
273186|NCT00012636|"~     Hypertension is a major risk factor for heart disease and stroke. Evidence-based guidelines~     support the use of specific drugs for patients with specific comorbidities to maximize the~     decrease in cardiovascular risk; yet, many physicians do not follow these guidelines in~     choosing drug therapy.~   "
273187|NCT00012623|"~     CBOCs represent one of VA's main managed care strategies for shifting the focus of care from~     the inpatient to the outpatient setting and for improving the health of our nation's~     veterans. Hypothesis-driven research is critically needed to test the basic assumptions~     motivating the expansion of CBOCs throughout the VA health care system.~   "
273188|NCT00012610|"~     Telepsychiatry is a novel means of providing expert psychiatric treatment to patients who~     live far from a source of care. If it can be demonstrated that treatment via telepsychiatry~     is as effective as in-person treatment, then many individuals with psychiatric illness will~     have easy access to psychiatric care, even if they live in geographically remote areas.~   "
273189|NCT00012597|"~     A Web-based telemedicine system for monitoring the status of patients with pressure ulcers~     has been developed. It consists of three major data collection components: (1) digital~     photograph of ulcer; (2) quantitative measurements of wound status (i.e., ulcer area and~     volume, skin elasticity); and (3) other wound and patient data collected by a nurse. Data are~     collected via laptop computer and transmitted to a central database, where a computer program~     transforms the data into the necessary reporting format. The output is posted onto a World~     Wide Web page for access by the consulting physician. The system incorporates all data~     requirements for assessment recommended by AHCPR's Clinical Practice Guideline, Treatment of~     Pressure Ulcers.~   "
273190|NCT00012584|"~     The purpose of this NIMH-sponsored pilot study is to collect information on the efficacy and~     safety of drug treatments for children and adolescents who suffer from both ADHD and anxiety~     disorders. Specifically, the study will examine the benefits of the stimulant medication both~     alone and in combination with fluvoxamine, a selective serotonin reuptake inhibitor (SSRI)~     that has antianxiety effects. Young people aged 6 to 17 diagnosed with these co-occurring~     disorders may be eligible to participate.~   "
273191|NCT00012558|"~     A long-term study of current treatments for bipolar disorder, including medications and~     psychosocial therapies.~   "
273192|NCT00012545|"~     This study will determine the best ways to collect, process and store umbilical cord blood~     from babies with sickle cell disease, sickle cell trait and unaffected babies. Sickle cell~     disease is an abnormality of the hemoglobin in red blood cells that causes the cells to~     change shape and clump together, preventing their normal flow in the bloodstream. This~     impairs blood flow to various organs, and the resulting oxygen deprivation causes organ~     damage.~      Cord blood is rich in stem cells (cells produced in the bone marrow that mature to different~     types of blood cells), which may prove useful in new sickle cell therapies. However, cord~     blood from babies with sickle cell trait, sickle cell disease and normal babies may act~     differently under laboratory conditions, so it is important to learn how best to work with~     blood from all three groups of babies for future use in possible treatments.~      Pregnant women between 18 and 45 years of age who are at risk of having an infant with sickle~     cell disease and normal volunteers who are pregnant and not at risk for this disease may be~     eligible for this study. Potential participants will be counseled about donating her infant s~     blood in order to make an informed choice.~      All women who participate in the study will provide a medical history and have blood~     collected from the umbilical cord and placenta (afterbirth) after the baby s delivery. The~     blood will be tested for various infectious diseases, processed, frozen and stored for~     research purposes. In addition, blood from women with babies at risk for sickle cell disease~     will be tested for the presence of the sickle cell gene, tissue typed, and used for research~     as follows:~        -  Sickle cell disease If cord blood tests show the baby has sickle cell disease, the blood~          will be frozen for an indefinite period of time for possible use in future treatment of~          the child. This treatment could include stem cell transplantation or gene therapy,~          treatments are not currently considered routine for sickle cell disease.~        -  Sickle cell trait or normal hemoglobin If cord blood tests show the baby has sickle cell~          trait or is unaffected, the blood will be processed and stored for up to 3 years, during~          which time it may possibly be used to treat a currently living or future sibling with~          sickle cell disease. After 3 years, the participant may agree to either have the blood~          discarded, given to research or moved to another facility for continued storage at the~          participant s expense, if there is a storage fee. Alternatively, if there is no~          anticipated future need for the collected blood, or if it does not meet standards needed~          for future treatment, it will be used in NIH-approved research studies.~      Participants and their family doctor or the baby s pediatrician will be contacted twice a~     year for information about changes in the baby s health. Participants may also be asked~     permission to perform new tests developed by researchers.~   "
273193|NCT00012506|"~     This study will investigate the safety and effectiveness of the drug Enbrel (TNFR:Fc) to~     treat uveitis (eye inflammation) in patients with juvenile rheumatoid arthritis.~   "
273194|NCT00012493|"~     This project is part of a program project directed toward assessing cardiac effects of~     particulate and other ambient air pollutants. In this project patient who have recently~     suffered a cardiac event are being monitored with cardiac monitors for 24 hours up to 4 times~     during the year following their cardiac event. Similarly a second group of patients with~     moderate to severe heart failure will undergo similar cardiac monitoring for 24 hours, twice~     a week separated by 3 months. In both sets of patients home indoor pollution measures will be~     continuously made and used to correlate with measures of heart rate variability.~   "
273195|NCT00012480|"~     Our data indicate that environmental exposure to the heavy metal lead are more widespread~     than currently appreciated and that such exposures are associated with the production of~     human male subfertility. Lead's effects are observed in male partners of infertile couples~     attending an IVF clinical, in men acting as semen donors in an artificial insemination~     program and in men representative of the general public. Our goal is to identify the~     mechanism(s) underlying lead's anti-fertility action.~   "
273196|NCT00012441|"~     Hemodialysis remains associated with a high mortality (approximately 22% per year) and many~     complications despite improvements over the last twenty years. Several nephrologists have~     suggested that increasing the frequency and amount of dialysis will result in improved~     outcomes. In fact, various forms of daily dialysis have been performed in over 300 patients~     in the last 30 years with improvements in blood pressure, quality-of-life, bone disease, and~     other complications of renal failure. Whether this form of treatment can be expanded to the~     220,000 Americans on hemodialysis is unknown. The primary outcome of this study is to~     determine the effectiveness of nocturnal dialysis in hemodialysis patients in St. Louis. If~     the pilot study is effective, then participation in a larger, multicenter trial is expected.~     The endpoints measured are use of antihypertensive medications, improvement in secondary~     hyperparathyroidism and use of phosphorus binders, quality-of-life measured by SF-36 surveys,~     and improvement in physical function as measured by maximal oxygen uptake.~   "
273197|NCT00012428|"~     This project is designed to investigate the association between prenatal exposure to~     environmental contaminants on cognitive development of school-age children~   "
273216|NCT00011622|"~     This proposal is a pilot study to describe the variations of blood sugar in pregnant women~     with various degrees of glucose intolerance, and how they relate to standardized meals. Blood~     sugar control during pregnancy is important to prevent complications for the newborn. The~     variation and timing of the blood sugar measurements in gestational diabetics and how this~     relates to the baby's outcome is controversial. We will use an FDA approved device called~     Minimed Glucose Continuous Monitor, which is used in clinical practice for certain diabetics.~     It is very small, similar to a beeper, and is connected to the patient through a small~     plastic catheter subcutaneously. This measures blood sugar every five minutes for a total of~     288 readings a day with minimum discomfort. The hypothesis of this study is that use of the~     Minimed glucose monitor will provide information about variations of blood sugar in~     gestational diabetics that is missed by capillary glucose monitors.~      Our conclusions will allow us to compare blood glucose trends among the groups. After the~     data is analyzed in this pilot study, we plan to design a bigger study involving more~     subjects to study the impact of the blood sugar variations in the outcome of the newborn, and~     to obtain generalizable results for the population in general.~   "
273273|NCT00010699|"~     The primary aim of the present study is to test the effect of alpha-tocopherol~     supplementation on the progression of carotid atherosclerosis in patients with coronary~     artery disease~   "
273198|NCT00011908|"~     This study will examine the safety of a new genetically engineered antibody called hLL2~     (epratuzumab) in patients with systemic lupus erythematosus (SLE). It will also evaluate~     whether hLL2 can lessen overall disease activity in SLE or kidney damage in patients with~     lupus nephritis.~      Patients 18 years of age and older with mild to moderately active SLE may be eligible for~     this study. Candidates will be screened with blood and urine tests, a chest X-ray,~     electrocardiogram (EKG), tuberculin skin test, and screening tests for certain cancers.~      All participants will receive weekly infusions of hLL2 for 4 weeks. The drug is given through~     a catheter (small plastic tube) placed through a needle in an arm vein. Each infusion takes~     about 2 hours, after which the patient is observed in the clinic for 1 to 2 hours before~     being discharged from the clinic.~      The first 3 patients in the study will receive the lowest of three different doses used in~     the study. If this dose is well tolerated, the next 5 patients will receive a higher dose. If~     the second dose is tolerated, the last 5 patients will be given the highest dose. If any~     serious problems are encountered at a dose, patients in the next group will receive either~     the same or lower dose before being advanced to the next level. Patients in the first group~     will continue taking prednisone at their regular dose. All other patients will have their~     prednisone tapered gradually, if their condition permits. Patients who have a disease flare~     may have their prednisone increased for up to 2 weeks, followed by a gradual taper. If the~     flare is severe or does not respond to the increased prednisone, the patient will be taken~     off the study and treated to control the disease.~      Patients will be evaluated at various intervals for up to 8 weeks after the last dose.~     Several of the screening tests will be repeated throughout the study. No more than 500 ml of~     blood-the equivalent of a single blood donation-will be collected during a 2-month period.~     Participants may also be asked to undergo the following optional procedures before starting~     treatment, 1 week after the last dose and 8 weeks after the last treatment dose:~        -  Bone marrow aspiration - to collect cells from the bone marrow. The hip area is~          anesthetized and a special needle is used to draw bone marrow from the hipbone.~        -  Tonsil biopsy - The area to be biopsied is numbed with a local anesthetic and small~          pieces of tissue will be removed with a special type of forceps. (The procedure may be~          done under general anesthetic.)~        -  Magnetic resonance imaging (MRI) of the abdomen - The patient lies on a table within a~          metal cylinder (the MRI scanner) for about 30 to 40 minutes while images are obtained~          with the use of a strong magnetic field and radio waves.~   "
273199|NCT00011856|"~     This study will investigate cerebral (brain) aneurysms and their possible inheritance~     patterns in families. It will try to determine how often brain aneurysms occur in families in~     which more than one member has had an aneurysm and to find the gene or genes that contribute~     to their development.~      People in families in which more than one family member had a cerebral aneurysm are eligible~     for this 1-day study. They will undergo the following procedures:~        -  Blood will be drawn (no more than 3 to 4 tablespoons) for research to identify genes~          that contribute to the development of brain aneurysms.~        -  A magnetic resonance angiograph (MRA) scan will be done to examine a specific brain area~          where aneurysms typically occur. Magnetic resonance imaging uses a strong magnetic field~          and radio waves to produce images of the brain and detect abnormalities.~      If a more detailed picture of the brain is needed than can be obtained with MRA, a more~     specific MRA scan will be done using a contrast dye to enhance the images.~      Patients may be invited to participate in related NIH research studies.~   "
273200|NCT00011843|"~     This study will try to learn more about the genetic cause and symptoms of microphthalmia~     (small eyes) or anophthalmia (absence of one or both eyes).~      Patients with microphthalmia or anophthalmia with mental retardation may be eligible for this~     study. Patients' parents and siblings will also be included for genetic studies. Patients may~     participate in both the clinical and laboratory parts of the study or just the laboratory~     part, as described below:~      Laboratory~      The laboratory study consists of DNA analysis to determine the genetic cause of~     microphthalmia/anophthalmia. The DNA sample is obtained using one of the following methods:~        -  Blood draw - for young children, a numbing cream is applied to the skin before the~          needlestick to decrease the pain~        -  Skin biopsy - a small piece of skin (about 1/8-inch in diameter) is removed surgically~          after the area has been numbed with an anesthetic~        -  Cotton swab - a specimen is collected from inside the cheek using a cotton swab. This is~          done only for patients who cannot provide a blood or skin sample.~        -  Prenatal sample - If, in the case of newborns, specimens are left from prenatal testing,~          these can be used instead of a blood sample.~      Some patients may have a permanent cell line grown from the blood or skin sample for use in~     future research tests.~      Clinical~      For the clinical study, participants undergo some or all of the following procedures at the~     NIH Clinical Center:~        -  Physical examination~        -  Clinical photographs, X-rays, blood tests~        -  Magnetic resonance imaging (MRI) scan of the brain - a diagnostic procedure that uses a~          magnetic field and radio waves instead of X-rays to produce images of the brain~   "
273201|NCT00011830|"~     This study will examine 1) whether it is possible to collect enough stem cells (cells~     produced by the bone marrow that mature into white and red blood cells and platelets) from~     patients with aplastic anemia to use for future treatment, and 2) whether patients who have~     been treated successfully and relapse will benefit from autologous stem cell transfusion~     (transfusion of their own stem cells).~      Patients 12 years of age or older with aplastic anemia who have been successfully treated~     with immunosuppressive drugs and are now in remission may be eligible for this study.~     Participants will undergo a complete history and physical examination, bone marrow biopsy~     (removal of a small sample of bone marrow from the hip bone) and blood tests, plus procedures~     to collect stem cells, as follows:~        -  G-CSF (Filgrastim) administration - G-CSF will be given by injection under the skin~          daily for up to 10 days. This drug causes stem cells to move from the marrow into the~          blood where they can be collected more easily.~        -  Apheresis - Stem cells will be collected through apheresis, usually starting the 5th to~          6th day of Filgrastim injections. For this procedure, whole blood is collected through a~          needle in an arm vein. The blood circulates through a cell separator machine where the~          white cells and stem cells are removed. The red cells, platelets and plasma are returned~          to the body through a second needle in the other arm. The procedure takes about 5 hours.~          Up to five procedures, done on consecutive days, may be required to collect enough cells~          for transplantation. If enough cells are collected, they will be purified (treated to~          remove the white blood cells) using an experimental device. Removing the lymphocytes may~          reduce the chance of relapse of aplastic anemia following the stem cell transplant. The~          stem cells will be frozen for later use, if needed.~        -  Follow-up - Participants are followed at NIH at 6-month intervals.~   "
273202|NCT00011817|"~     This study offers evaluation and treatment for patients with inherited (genetic) eye~     diseases. The protocol is not designed to test new treatments; rather, patients will receive~     current standard of care treatments. The purpose of the study is twofold: 1) to allow~     National Eye (NEI) Institute physicians to increase their knowledge of various genetic eye~     diseases, identify possible new avenues of research in this area, and maintain their clinical~     skills; and 2) to establish a pool of patients who may be eligible for new studies as they~     are developed. (Participants in this protocol will not be required to join a new study; the~     decision will be voluntary.)~      Children and adults with genetic eye diseases may be eligible for this study. Candidates will~     be screened with a medical and family history, thorough eye examination and blood test. The~     eye examination includes measurements of eye pressure and visual acuity (ability to see the~     vision chart) and dilation of the pupils with eye drops to examine the lens and retina (back~     part of the eye). Patients may also undergo additional diagnostic tests needed to determine~     eligibility for other NEI studies, including routine laboratory testing, imaging,~     questionnaires, a physical examination, and other standard and specialized tests and~     procedures as needed. In addition, patients will have special photographs taken of the eye to~     document the clarity or opacity of the eye lens. They will also undergo a procedure called~     electroretinography to assess the eye's response to bright lights. For this procedure, the~     eye is numbed with anesthetic drops and a contact lens is placed in the eye. The patient~     looks inside a large, hollow sphere and sees flashes of light, first in darkness and then in~     light. The contact lenses sense small electrical signals generated by the retina.~      Patients who need medical care will be given appropriate standard medical treatment. Those~     who are found eligible for a research study will be recommended for participation in that~     study and taken off this one.~      Participants will be followed at least 3 years. Follow-up visits are scheduled according to~     the standard of care for the individual patient's eye problem. Patients in this protocol will~     probably have 1 to 3 follow-up visits per year.~   "
273203|NCT00011804|"~     This study will test the effectiveness of topiramate to treat pain caused by lumbar~     radiculopathy, or sciatica. Sciatica results from damage to the lumbar nerve roots, typically~     causing back pain and sharp, shooting pain down one or both legs. Although sciatica is~     common, there are no good treatments for it. Topiramate belongs to a group of medications~     commonly used to treat pain caused by nerve damage.~      Patients between 18 and 75 years of age who have had sciatica pain daily for at least 3~     months may be eligible for this study. (This is taken from the first paragraph of the~     Qualification Criteria in the consent form. The inclusion criteria on page 6 of the protocol~     say low back pain of 3 months duration or longer present at least 5 out of 7 days a week~     and signs and symptoms of lumbar radiculopathy. Which is correct?)~      Participants will provide a medical history, as well as occupational and social information.~     They will undergo a standard neurological examination, including a test of cognitive~     (thinking) abilities, muscular function, reflexes and a sensory examination. The latter~     involves testing with a pin placed on the surface of the skin. Participants will also have~     routine blood tests and will fill out questionnaires on their daily functioning and~     psychological well being. Additional procedures may include magnetic resonance imaging (MRI)~     scans and possible referral to a psychiatrist for evaluation of depression or emotional~     difficulties.~      This cross-over study consists of two parts. In one part, patients will receive topiramate~     and in the other, an active placebo. An active placebo is a drug that does not work for the~     problem being studied but whose side effects are like those of the test drug. Diphenhydramine~     (Benadryl) is the active placebo used in this study. Diphenhydramine is an allergy medication~     with very mild side effects, such as drowsiness. During both parts of the study-topiramate~     and placebo-patients will keep a daily log in which they rate their pain, record other~     procedures they undergo, such as injections and manipulations, and record medication side~     effects.~      In the first week of the study, patients will remain on their current medications and record~     pain levels once a day. After the first week, they will begin taking the study drugs-either~     topiramate in increasing doses ranging from 50 to 400 mg. or diphenhydramine in doses ranging~     from 6.25 to 50 mg. The drug doses will be increased gradually over 4 weeks to minimize~     possible side effects. Increases will continue until the maximum tolerated dose is reached.~     Patients will continue on the highest tolerated dose for two weeks and then be tapered off~     gradually over 12 days. They will remain off drugs completely for a 2-day washout period and~     then begin the next treatment. Those who took topiramate for the first part will take~     diphenhydramine for the second part and vice versa.~      A study nurse will call patients twice a week throughout the study to check for problems and~     answer questions. A physician will see patients 6 weeks after the start of each treatment.~     During the last visit, at the end of the study, patients will repeat the questionnaires they~     filled out at the beginning of the study. Patients and their doctors will be informed of the~     medications that were effective in each individual's care.~   "
273207|NCT00011752|"~     This study uses positron emission tomography (PET) scanning to study how serotonin works in~     alcoholics. Serotonin is a chemical that allows brain cells to communicate. There is evidence~     that people with alcoholism have altered serotonin; their brains begin to make and break down~     serotonin more slowly than people who do not drink. PET scans use radioactive substances~     injected into the body. A special camera detects the radiation emitted by the radioactive~     fluid and a computer processes the radioactivity into images of the brain, which show the~     activity of brain chemicals like serotonin.~      People with alcohol dependency may participate in this study. Candidates are screened with a~     medical history, including questions about alcohol and drug use, physical examination, blood~     tests, breath alcohol tests, electrocardiogram (ECG), urine test for illicit drugs and, for~     women, a pregnancy test, and a stool test for hidden blood. They also undergo magnetic~     resonance imaging (MRI) scan of the brain and complete questionnaires on their alcohol and~     drug history.~      Participants undergo the following tests and procedures:~        -  Diet low in tryptophan. Tryptophan is an amino acid from which serotonin is made.~        -  Brain MRI before starting the study to make sure brain structure is normal.~        -  Lumbar puncture (spinal tap) to collect a small sample of cerebrospinal fluid (CSF). A~          local anesthetic is given and a needle is inserted in the space between the bones~          (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the~          needle.~        -  Arterial catheter (plastic tube) placed in an artery in the wrist area for drawing blood~          samples. The skin is numbed with a local anesthetic for placement of the catheter.~        -  Intravenous (IV) catheter placed in a vein for injecting the radioactive isotope used in~          the PET scan.~        -  Two PET scans - baseline and active.~        -  Amino acid drink (orange flavored) before the active PET scan. The drink lowers~          tryptophan levels.~        -  Amino acid capsules - 23 amino acid capsules are taken with the orange drink.~        -  Genetic analysis to help understand serotonin and alcoholism. A blood sample is~          collected for DNA testing and possibly establishment of a cell line (collection of cells~          that are grown in the laboratory from an original tissue specimen) for other genetic~          studies.~      Patients are admitted to the intensive care unit for the lumbar puncture and arterial line~     procedures. After these procedures are complete, the patient is transferred by stretcher to~     the PET suite for scanning. During the two scans, blood samples are drawn from the artery and~     a small amount of CSF is collected each hour of the study. Each PET scanning session lasts~     about 3 hours. The study lasts 36 hours, during which time the subject remains in bed.~   "
273208|NCT00011739|"~     Low back pain is a frequent cause of disability and a common reason for outpatient care in~     veterans. Magnetic resonance imaging (MRI) of the lower back often reveals~     abnormalities,which may be used to justify expensive and invasive therapy, such as surgery.~     Yet the link between MRI abnormalities and the risk of developing clinically significant back~     pain is far from clear. This longitudinal study will determine the prevalence and incidence~     of MRI abnormalities among veterans and determine the extent to which specific MRI~     abnormalities predict future development of back pain. The result should help clinicians use~     MR imaging more efficiently, and they may ultimately help reduce the frequency of unnecessary~     back surgery.~   "
273209|NCT00011726|"~     We are examining the role of maternal bone lead turnover during pregnancy and lactation as a~     potential source of lead exposure for the fetus and the infant (via breast milk). A cohort,~     ascertained at entry to care, consists of >1000 women to be followed through pregnancy. In~     the postpartum subjects are recruited for a nested case control study to assess the influence~     of lactation on maternal bone density, maternal blood lead and breast milk lead.~   "
273210|NCT00011713|"~     The purpose of the study is to investigate the relationship between environmental agents and~     reproductive health. Environmental agents of interest include exposure to chemicals such as~     polychlorinated biphenyls (PCBs), flame retardants, dioxins, bisphenol A, phthalates,~     pesticides, and metals like lead and cadmium. We are also interested in the relationship~     between reproductive health and lifestyle risk factors, such as exposure to environmental~     tobacco smoke. Enrollees are asked to participate in this study because they and their~     partner are patients of the MGH Fertility Center, trying to get pregnant, either naturally or~     by undergoing Intrauterine Insemination (IUI) and/or In Vitro Fertilization (IVF).~   "
273211|NCT00011700|"~     The majority of the workscope of this project is focussed on an infant animal model of~     toxigenic mold induced pulmonary hemorrhage. Clinically related studies are directed only to~     the description of human infants diagnosed with idiopathic pulmonary hemorrhage regarding~     their clinical parameters, and collecting samples of secretion, blood, and urine for analysis~     for fungal spores and mycotoxins. These latter analyses are being developed using the infant~     rat model.~   "
273212|NCT00011687|"~     The Study for Future Families is a multi-center study that is recruiting pregnant women and~     their partners in four US cities to look for differences between cities in several measures~     of reproductive health. These measures include how long it took couples to conceive as well~     as hormone levels and semen quality in the male partners. This study is modeled after a study~     in four European cities so that,when complete, data on the 300 couples in each of the eight~     cities can be compared.~   "
273213|NCT00011674|"~     This prospective cohort study examines the role of prenatal and early postnatal lead exposure~     on the neuropsychological status and social adjustment of adolescents enrolled in the~     Cincinnati Lead Study. We are examining the relationship between moderate exposure to lead~     and neuropsychological deficits, difficulties in peer relationships, personality disturbances~     and juvenile delinquency. This birth cohort of approximately 300 subjects has been followed~     since 1980 with regularly scheduled assessments of blood lead concentrations, health history,~     social and hereditary factors, and neurobehavioral development.~   "
273214|NCT00011661|"~     The purpose of this study is to examine whether adding an inter-generational component to an~     existing social network-based lay health advisor intervention increases its effectiveness in~     mobilizing a Native American community to respond to heavy metal contamination from lead and~     zinc mining.~   "
273215|NCT00011648|"~     The purpose of this study is to determine how often people with sickle cell anemia develop~     pulmonary hypertension a serious disease in which blood pressure in the artery to the lungs~     is elevated.~      Men and women 18 years of age and older with sickle cell anemia may be eligible for this~     study. Participants will undergo an evaluation at Howard University s Comprehensive Sickle~     Cell Center in Washington, D.C. or at the National Institutes of Health in Bethesda,~     Maryland. It will include the following:~        -  medical history~        -  physical examination~        -  blood collection (no more than 50 ml., or about 1/3 cup) to confirm the diagnosis of~          sickle cell anemia, sickle cell trait or beta-thalassemia (Some blood will be stored for~          future research testing on sickle cell anemia.)~        -  echocardiogram (ultrasound test of the heart) to check the pumping action of the heart~          and the rate at which blood travels through the tricuspid valve.~      Following this evaluation, a study nurse will contact participants twice a month for 2 months~     and then once every 3 months for the next 3 years for a telephone interview. The interview~     will include questions about general health and recent health-related events, such as~     hospitalizations or emergency room visits.~   "
273274|NCT00010686|"~     The purpose of this study is to determine whether dietary phytoestrogens are an effective~     alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss.~   "
273275|NCT00010634|"~     This study aims to assess selected naturopathic medicines for adult periodontitis and to~     identify variables that influence successful outcomes when traditional and alternative~     approaches to preventing and treating periodontal diseases are combined. Collaboration~     between Kaiser Permanente, Oregon Health Science University and the National College of~     Naturopathic Medicine provides an unsurpassed environment for such investigations.~     Periodontitis is a major cause of tooth loss and negatively impacts systemic health. The~     limitations of traditional periodontal treatment have compelled scientists and clinicians to~     investigate new remedies, and naturopathic medicine holds several promising interventions.~      Because they are used to improve elements of host resistance that are known to be important~     in periodontal health and disease, three naturopathic medicines are potential adjuncts in~     preventing and treating periodontitis. Connective tissue components are enzymatically~     degraded in periodontitis. In naturopathy, Connective Tissue Nutrient Formula (CTNF)~     (vitamins A, C and D, glucosamine sulfate, oligoproanthocyanindins, copper, zinc, manganese,~     boron, silicon, magnesium, and calcium) is prescribed specifically to enhance the integrity~     of key connective tissue elements and improve their resistance to degradation. Periodontitis~     begins when permeability of the oral sulcular epithelium permits pathogenic bacterial~     components to invade deeper periodontal connective tissues. In naturopathy, glutamine is~     prescribed to reduce oral-intestinal epithelial membrane permeability. Chronic activation of~     the hypothalamic-pituitary-adrenal (HPA) axis during the stress response, is a risk factor~     for periodontitis. Adaptogenic herbs (AH) (Panax ginseng, Withania somnifera and~     Eleutherococcus senticosus) are prescribed by naturopathic physicians to reverse the impact~     of bacterial and psychosocial stressors. Because glutamine, CTNF and AH target~     pathophysiologic mechanisms known to underline periodontitis, they are compelling candidates~     in clinical and mechanistic investigations of complementary medicine approaches to the~     management of periodontitis.~      Kaiser Permanente adult periodontitis patients will serve as subjects and receive standard~     periodontal treatment. Three of the four randomly assigned groups will also receive~     supplements of glutamine, CTNF, or AH. We will determine the effects of these supplements on~     clinical outcomes (attachment loss, pocket depths, indicators of inflammation, plaque~     composition, need for periodontal surgery, acute periodontal problems, tooth loss). In~     addition to completing the battery of self-report measures (stress, coping, quality of life),~     study subjects will provide samples of blood, saliva, gingival cervicular fluid and bacterial~     dental plaque. These samples will be examined as part of the Laboratory Core to identify~     biologic and genetic characteristics that correlate with successful outcomes. Storage of~     portions of the samples will allow future examination of additional variables as part of the~     Developmental Projects carried out as the Craniofacial Complementary & Alternative Center is~     established and Phase III trials are undertaken.~   "
273218|NCT00011596|"~     To date, conventional rehabilitation is not able to restore normal, safe, gait for many~     individuals with stroke. We have identified nine gait component deficits which respond to the~     FNS-IM intervention. This study will test a refined treatment protocol of 3 months duration~     to restore volitional gait by restoring those nine gait components simultaneously. In~     addition, we will incorporate into the treatment protocol a promising non-invasive technique~     of partial body weight-supported (BWS) gait training on a treadmill. BWS and FNS-IM have the~     potential to provide additive effects for the patient and restore volitional gait more~     quickly and more completely than would otherwise be possible with one technique alone.~   "
273219|NCT00011583|"~     Our long term objectives are to understand the mechanisms of motor impairment following~     neurologic injury and to develop interventions to improve motor recovery. A series of~     complementary, overlapping clinical trials and development activities will validate and~     optimize the use of robot-assisted upper limb therapy for neuro rehabilitation.~      We have developed a robotic system that assists or resists elbow and shoulder movements in~     three dimensional space. In addition to unilateral exercise modes, a novel bimanual mode~     enables hemiparetic subjects to practice mirror image upper limb exercises.~   "
273220|NCT00011570|"~     The investigators will continue their work with implanted stimulators to improve bladder and~     bowel function. Electrical stimulation produces simultaneous contraction of sphincters with~     the target organs, making emptying difficult. By optimizing electrode placement, employing a~     new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to~     defecate with existing approaches. This is part of a multi-center study with multiple support~     sources, including Rehab R&D, PVA and a commercial stimulator company.~   "
273221|NCT00011557|"~     This project will determine the ultimate usefulness of functional magnetic stimulation (FMS)~     as an assistive device for voiding in patients with SCI.~   "
273222|NCT00011544|"~     The project is intended to modify the Functional Independence Measure (FIM) for manual~     wheelchair users. It will determine if the new measure is a better measure of community~     independence for manual wheelchair users than the FIM. During the Phase 1 of the study it~     will then use this new measure to determine whether a home exercise program increases~     functional independence in wheelchair users. In Phases II and III of the study 120 manual~     wheelchair users will participate to test and validate the new measure and to test the~     effectiveness of therapeutic exercise. Subjects will range in age from 20 to 79 yrs. and have~     a variety of disabilities.~   "
273223|NCT00011531|"~     Many spinal cord injury (SCI) and otherwise debilitated patients develop pressure ulcers over~     the course of their injury or disease. Despite enhanced wound care management, many pressure~     ulcers do not heal completely and require surgical myocutaneous rotational flap coverage.~     Even then they often recur.~      The objectives of this study are: (1) to conduct a controlled comparative study of the~     effectiveness of subatmospheric pressure dressing (SPD) in healing pressure ulcers versus~     conventional saline wet-to-moist dressing techniques; (2) to establish indications and~     contra-indications for use of SPD In treating pressure ulcers; and (3) to develop a~     noninvasive, clinically usable optical digitizer and associated software for measurement of~     wound geometry for standardized quantitative assessment and longitudinal monitoring of wound~     healing.~   "
273224|NCT00011518|"~     This study is examining the relationship between ingested arsenic and bladder cancer in two~     areas of California where a large percentage of the population was exposed to drinking water~     containing arsenic at low to moderate levels.~   "
273225|NCT00011505|"~     This study will provide information needed to develop more effective treatments for patients~     with Diamond-Blackfan anemia (DBA). Current treatments include steroids, such as prednisone,~     and blood transfusions. These treatments have potential long-term risk and side effects,~     including osteoporosis and impaired growth from steroids or iron overload from transfusions.~     In addition, as patients reach adulthood, they can develop acute leukemia or bone marrow~     failure. The only cure for DBA is bone marrow transplant, a procedure that itself carries~     serious risks and is an option for only about 25 percent of patients.~      DBA is caused by a mutation (error) in a gene that codes for producing red blood cells from~     stem cells (blood-forming cells produced by the bone marrow). In 5 to 10 years, gene transfer~     therapy may prove to be an effective treatment for DBA. Before this treatment can be~     considered, however, more information is needed about DBA patients and how their stem cells~     function. This study will examine: 1) whether stem cells of patients with DBA respond to~     G-CSF the same way those of healthy people do. (G-CSF is a drug that causes stem cells to~     move from the bone marrow to the blood stream, where they can be collected more easily and in~     larger numbers by a procedure called leukapheresis, described below. If G-CSF does not work~     well in DBA patients, other collection strategies will have to be explored); and 2) whether~     the genetic error in DBA can be corrected by gene transfer into patients' stem cells.~      Patients with Diamond-Blackfan anemia 4 years of age and older who weigh at least 27 pounds~     and who are dependent on red blood cell transfusions may be eligible for this study.~     Candidates will have a medical history taken and a physical examination and will be seen by~     the Clinical Center's Department of Medicine Transfusion for leukapheresis evaluation. They~     will have a bone marrow aspiration and biopsy to confirm the diagnosis of DBA. For these~     tests, the hip area is anesthetized and a needle is used to draw bone marrow from the~     hipbone. If needed, the procedure will be done under sedation.~      Patients will be given G-CSF by injection under the skin for up to 6 days. Blood and stem~     cell counts will be measured from a teaspoon of blood drawn each morning. On the morning of~     the fifth dose, the patient will undergo leukapheresis for collection of stem cells. For this~     procedure, a large catheter (with a diameter no larger than that of a straw) is placed in an~     arm vein to allow blood to flow into a cell separator machine. Most children and some adults~     do not have veins large and strong enough for this tubing, so a large intravenous line called~     a central line is placed into a large vein in the neck or groin. This is done under~     sedation and with a local anesthetic. While the patient lies on a bed or recliner, whole~     blood is collected through a catheter in one arm or the central line, the stem cells are~     separated out by spinning, then the red cells, platelets and plasma are returned through a~     second catheter in the other arm or a second opening in the central line. The procedure takes~     about 3 to 5 hours, during which the patient can watch television or videos and have family~     members at the bedside for company. When the procedure is completed, the patient's~     participation in the protocol ends.~      Some of the stem cells collected by leukapheresis will be used for research and some will be~     frozen and stored for possible future transplantation into the patient, if required.~   "
273226|NCT00011492|"~     This purpose of this protocol is to evaluate and identify patients who may be eligible for~     actively enrolling NIH clinical research protocols for head and neck cancer; or provide~     standard evaluations and treatment necessary for patients with head and neck cancers enrolled~     in other NIH clinical protocols that do not include such treatment. Participants screened~     under this protocol will not be required to join a research study; the decision will be~     voluntary.~      Patients with head and neck cancer may enroll in this study. Participants may undergo various~     tests, described below, to determine their eligibility for participation in a specific~     clinical trial. Other tests may also be required, depending on the protocol or treatment for~     which the patient is being considered:~        -  Blood tests About 3 to 5 tablespoons of blood will be drawn for routine tests, HLA~          typing and hepatitis and HIV screening.~        -  Magnetic resonance imaging (MRI) This imaging procedure uses a powerful magnetic field~          to produce pictures of parts of the body in small section views. The test does not use~          radiation and may be done with or without a contrast dye material.~        -  Computerized tomography (CT) This procedure uses x-rays to produces three-dimensional~          images of body organs in small section views. A contrast dye may or may not be used.~        -  Positron emission tomography (PET) PET scans allow the doctor to see the activity of~          cells in specific body tissues. It requires injection of a radioactive material that~          attaches to a sugar fluid. The fluid goes to very active cells, such as cancer cells,~          revealing tumors.~        -  Pulmonary function tests These tests use a machine the patient breathes into to measure~          the volume of air the patient can move in and out of the lungs.~        -  Arteriogram, or angiogram The anatomy of the blood vessels can be seen using this~          procedure, which involves placing a small catheter (plastic tube) into an artery and~          injecting a contrast solution. Special X-rays are then taken to show the blood vessels.~        -  Endoscopy This procedure is done to evaluate the mouth and throat. A tube with a light~          on the end and special fibers is inserted down the throat to allow the surgeon to~          examine the throat and, if needed, biopsy a piece of tissue for microscopic study. The~          test is usually done under general anesthesia in the operating room.~        -  Biopsy A piece of tissue or tumor is removed for examination under the microscope. When~          a biopsy is done in the neck area, a small amount of anesthetic is injected into the~          area of the biopsy. The biopsy may be done with 1) a small needle to pull out some~          tissue, 2) a cookie-cutter-like instrument to punch out a small piece of tissue, or 3) a~          small knife to cut out a piece of tissue. A knife biopsy may be done in the operating~          room or the clinic depending on the location of the biopsy and precautions required.~      When the tests are done, the physician will discuss the results with the patient. Patients~     eligible for a research study will be offered participation. For those not eligible for a~     study, other therapies will be discussed and the patient will return to the care of his or~     her primary physician. In special circumstances, patients may be offered standard~     non-experimental treatment at NIH.~   "
273227|NCT00011466|"~     Specific nutrient deficiencies have been described in children with ADHD including zinc,~     magnesium, calcium, and essential fatty acids. In addition, children with ADHD have been~     noted to behave and concentrate better in some studies when the ratio of protein compared~     with carbohydrate in their diets was increased, however, this was anecdotal information noted~     from studies designed to study other factors, so its not clear if the increased protein is~     actually the cause of the improved behavior. In our clinical practice, we have noted a high~     incidence of what appears to be carbohydrate craving among children with ADHD, which can~     put children at risk for obesity, diabetes type II, and additional dysregulation of mood and~     concentration. Carbohydrate craving is a well-documented phenomenon in adults, particularly~     those with certain patterns of obesity, mood disorders, or those undergoing smoking cessation~     programs. It has not been studied in children, however. Thus, this initial study was designed~     to determine 1) whether or not children with ADHD have different patterns of nutrient intake~     compared with children in the same family and children in families without a child with ADHD,~     2) if the described nutrient deficiencies are due to decreased intake, and 3) whether there~     is an increased occurrence of carbohydrate craving, based on parents' perceptions, eating~     patterns, and actual intake, among children (or certain subgroups of children) with ADHD. The~     information gained from this study will be used to design additional studies to test~     causative hypotheses and intervention strategies.~   "
273228|NCT00011453|"~     We are investigating the role of an enzyme (NQO1) in protection against the bone marrow~     toxicity of the occupational and environmental toxicant benzene. All of the proposed studies~     involve use of human bone marrow cells in-vitro to define mechanisms of NQO1-mediated~     protection. Cells are obtained from healthy volunteers and protocols have undergone IRB~     review and approval.~   "
273229|NCT00011440|"~     This study is designed to investigate whether exposure to particulate air pollution increases~     the allergic response to allergens. Research studies suggest that symptoms in individuals~     with allergies may be aggravated by exposure to particulate air pollution. We sought to~     experimental determine this by exposing human volunteers to combustion particles, a component~     of air pollution, and then challenge them with an allergen such as ragweed or oak tree~     pollen. Using biological tests we can measure whether the allergen response is magnified by~     prior particulate exposure.~   "
273276|NCT00010621|"~     This study will determine whether selected complementary approaches to temporomandibular~     joint (TMJ) pain management-acupuncture are as effective as usual care.~   "
273277|NCT00010608|"~     The purpose of this study is to evaluate the effectiveness of meditation in preventing of~     atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.~   "
273278|NCT00010530|"~     The purpose of this study is to evaluate the effects of meditation on older African Americans~     with documented cardiovascular disease (CVD).~   "
273230|NCT00011414|"~     This study will evaluate the tolerance and effects of tariquidar, given in combination with~     one of three anticancer drugs, for treating solid tumors. Tariquidar works by blocking a pump~     on a cancer cell. The pump on a cell that prevents anticancer drugs from accumulating is~     called Pgp (P-glycoprotein). Researchers hope to see whether cancer-fighting drugs can stay~     in the cells longer.~      Patients ages 2 to 18 who have solid tumors may be eligible for this study. Tariquidar is~     infused intravenously (IV) over 30 minutes, given every 21 to 28 days, with one drug that~     kills cancer cells. Patients are examined by a doctor at least once weekly during treatment~     and will have routine blood tests twice weekly. They will receive one of the following drugs~     with tariquidar: doxorubicin (Adriamycin ), vinorelbine (Navelbine ), or docetaxel (Taxotere~     ). At the first treatment cycle only, there is a baseline Sestamibi scan before treatment and~     a second one immediately after drug administration. If patients receive tariquidar with~     doxorubicin, tariquidar is given alone. Then 48 to 72 hours later, the second dose is given,~     followed by doxorubicin by IV over 15 minutes. Dexrazoxane, which decreases damaging effects~     of doxorubicin on the heart, is also given by IV over 15 minutes. Granulocyte colony~     stimulating factor (G-CSF) is injected daily 48 hours after doxorubicin, to alleviate~     doxorubicin s effect on white blood cells. If patients receive tariquidar with vinorelbine,~     tariquidar is given alone. Then 48 to 72 hours later, the second dose is given, immediately~     followed by vinorelbine by IV over 10 minutes; then 1 week later, tariquidar is again given,~     immediately followed by vinorelbine by IV for 10 minutes. G-CSF is given daily. If patients~     receive tariquidar with docetaxel, tariquidar is given alone. Then 48 to 72 hours later, the~     second dose is given, followed by docetaxel by IV over 60 minutes. Drugs to prevent allergic~     reactions are given before and after each docetaxel dose. G-CSF is given daily.~      Tariquidar may affect blood pressure during infusion, and there can be reduction of normal~     blood cells, gastrointestinal problems, and allergic reactions. The radioactive Sestamibi can~     cause headache, chest pain, and nausea. Radiation used in this study has been approved as~     involving a slightly greater than minimal risk for adults and an acceptable risk for~     children. This radiation is considered necessary to obtain information desired. One possible~     effect is a slight increase in the risk of cancer.~      This study may or may not have a direct benefit for participants. However, knowledge gained~     may benefit people with cancer in the future.~   "
273231|NCT00011388|"~     This project is examining the reproductive effects of exposure to certain compounds that are~     suspected to act on the endocrine system, e.g. they may act like or interfere with hormones~     such as estrogen. The study is being conducted among Laotian women, as it is suspected that~     they may have higher exposures to the compounds of interest (pesticides and PCBs) from their~     homeland and from consumption of fish caught in the San Francisco Bay. Fifty Laotian~     immigrants were recruited by community workers to collect urine daily during 3 menstrual~     cycles for measurement of steroid hormones (estrogen and progesterone). Additionally, they~     provided a blood sample to measure exposure levels, and completed 2 interviews in their~     native language. These measured levels, as well as the self-reported data on a number of~     factors including fish consumption, will be examined for possible effects on hormone levels~     and menstrual function.~   "
273232|NCT00011375|"~     This study will evaluate the safety, tolerability, and effect of the drug Rolipram on~     multiple sclerosis (MS). It will examine whether Rolipram can dampen the part of the immune~     response believed to lead to MS and reduce disease activity.~      Patient with multiple sclerosis who are between the ages of 18 and 65 may be eligible for~     this study. Candidates will be screened with a complete neurological and medical evaluation.~     Participants will complete three study phases-baseline, treatment and follow-up, as follows:~      Baseline (3 months) - Approximately four magnetic resonance imaging (MRI) scans will be~     obtained to assess MS activity. Participants with MS activity above a certain level will~     continue with the treatment phase.~      Treatment (8 months) - Patients will take Rolipram tablets in increasing doses every 2 to 3~     days for the first month of this phase until their individual maximum tolerated dose is~     established. Dosing will continue at that level for the rest of the treatment phase. Dosing~     is in the morning, midday and evening. Patients will be seen monthly in the clinic for~     examination and MRI scans.~      Follow-up - Participants will have monthly exams and MRIs for 3 months following the~     treatment phase, after which their participation in the study ends.~      Patients' monthly visits during treatment and follow-up include a neurological examination to~     assess disease status; MRI to assess brain changes; and blood and urine collection to monitor~     liver, kidney and other functions. In addition, a lumbar puncture (spinal tap) is done during~     the last month of the baseline phase and one month after treatment ends to study changes in~     the spinal fluid surrounding the brain and spinal cord, and leukapheresis is done once during~     the last month of the baseline phase and once during the last month of treatment to collect~     white blood cells for study. These procedures involve the following:~      MRI uses a strong magnetic field and radio waves instead of X-rays to produce images showing~     structural and chemical changes in tissues. The patient lies on a table in a narrow cylinder~     (the scanner) containing a magnetic field and images are taken. A contrast agent called~     gadolinium is injected into a vein during the last set of images to help identify new~     lesions. Magnetic resonance spectroscopy, which is similar to MRI, is also done once during~     the baseline phase, at 4 months and at 8 months to measure brain chemicals. For the spinal~     tap, a local anesthetic is given and a needle is inserted in the space between the bones~     (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.~     For leukapheresis, whole blood is collected through a needle placed in an arm vein. The blood~     circulates through a machine that separates it into its components. The white cells are~     removed and the red cells, platelets and plasma are returned to the body through a second~     needle placed in the other arm.~      Patients may also have studies to measure levels of Rolipram in the blood. These are done on~     study days 1 and 29 and at months 2, 4, and 6. For days 1 and 29, a catheter is placed in an~     arm vein and 4 ml. of blood is drawn immediately before the morning dose and at several~     intervals from 20 minutes to 6 hours after the dose. For the other tests, a single 4-ml~     sample is collected before the noon dose.~   "
273233|NCT00011362|"~     Infants who are on breathing support are often treated with steroids (dexamethasone);~     however, the best timing of therapy is not known. This trial looked at the benefits and~     hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in~     premature infants.~   "
273234|NCT00011349|"~     Environmental factors such as diet and cigarette smoking may play a role in predicting the~     progression of early stage prostate cancer to advance disease. The goal of this project is to~     establish an observational cohort of patients with early stage prostate cancer who elect not~     to undergo radical prostatectomy or radiation therapy to evaluate risk factors which predict~     the transformation of early stage to clinically aggressive disease.~   "
273235|NCT00011336|"~     This study is using a standardized method to assess respiratory function in SCI in order to~     determine the association between level of SCI with chronic respiratory symptoms, measures of~     pulmonary function, and respiratory illness, both cross-sectionally and longitudinally.~   "
273236|NCT00011323|"~     The goals of this project are to establish a new cohort of male veterans and describe~     associations between potential risk factors and baseline bone mineral density (BMD) as well~     as rates of BMD loss.~   "
273237|NCT00011310|"~     The aim of this study is to assess cardiac rate and respiratory responses and rhythm after~     workplace exposure to combustion particulates. A repeated measurement study is being~     performed on acute boilermakers (apprentices and journeymen). A stratified analysis is then~     done on those with and without chronic bronchitis, after adjustment for relevant covariates.~   "
273238|NCT00011297|"~     This study will evaluate a safe and useful medication for outpatient detoxification that is~     as effective as benzodiazepines in the short-term, and more effective in the protracted~     withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine,~     lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.~   "
273239|NCT00011284|"~     White blood cells can cause liver damage if they inappropriately accumulate in the liver in~     large numbers. Such an event can occur if an individual's blood is exposed to endotoxin, a~     substance released from the cell walls of many species of bacteria. The purpose of this study~     is to isolate neutrophils, an important white blood cell, from the blood of normal~     volunteers, and put them in tissue culture with isolated liver cells. The experiments will~     determine how endotoxin can increase the ability of neutrophils to damage liver cells. All~     studies supported by this grant will be done with isolated cells in tissue culture. This~     experimental model will reveal possible mechanisms that can in the future be evaluated in~     human diseases such as bacterial sepsis.~   "
273240|NCT00011258|"~     Atherosclerosis of the carotid arteries is a common cause of stroke. The prevalence and~     progression of carotid atherosclerosis are believed to be influenced by genetically inherited~     variations in lipoprotein metabolism. This study investigates the specific role of~     paraoxonase, an enzyme thought to detoxify atherogenic oxidized low-density lipoprotein. This~     study compares veterans who have significant carotid atherosclerosis on ultrasound~     examination with controls without carotid atherosclerosis. Both paraoxonase activity and~     genotype will be determined and compared between groups. The results may eventually make it~     possible to screen for a paraoxonase allele that confers high risk of atherosclerosis, and to~     diminish the risk by early treatment.~   "
273279|NCT00010517|"~     The current large randomized placebo-controlled trial is testing the ability of acupuncture~     to treat major depression. The study is unique in that treatment effects will be from the~     perspective of both Western psychiatry and Chinese medicine.~   "
273321|NCT00008827|"~     This project is assessing the effectiveness of using the Internet as a tool to facilitate the~     maintenance of weight lost in a behavioral weight control program. Participants attend a~     standard behavioral weight control intervention via Interactive Television and after 6 months~     are randomly assigned to one of three groups; a control group, an in-person weight~     maintenance group and a maintenance group that meets over the Internet. This research project~     is being conducted in Vermont.~   "
274058|NCT00005213|"~     To conduct ancillary studies of sodium-stimulated lithium counter-transport in the Chicago~     components of the Coronary Heart Disease Risk Development in Young Adults (CARDIA) cohort and~     in the Treatment of Mild Hypertension Study (TOMHS) cohort.~   "
273241|NCT00011245|"~     The goal of this study is to establish the mechanism(s) of progression of primarily spinal~     syringomyelia (PSS). Our preliminary study of syringomyelia emphasized syringomyelia~     associated with craniocervical junction abnormalities (CCJAS), such as the Chiari I~     malformation. This new protocol will expand the scope of our investigation to include~     primarily spinal syringomyelia (PSS), which is defined as syringomyelia not associated with~     craniocervical junction abnormalities (CCJAS). Etiologies of primarily spinal syringomyelia~     include 1) intradural scarring which is post-traumatic, post-inflammatory, or post-operative,~     2) intradural-extramedullary masses such as arachnoid cysts or meningiomas, and 3)~     extramedullary-extradural spinal lesions such as cervical spondylosis or spinal deformity.~      Our hypothesis is the following: Primarily spinal syringomyelia (PSS), results from~     obstruction of cerebrospinal fluid (CSF) flow within the spinal subarachnoid space; this~     obstruction affects spinal CSF dynamics because the spinal subarachnoid space accepts the~     fluid that is displaced from the intracranial subarachnoid space as the brain expands during~     cardiac systole; in the case of primarily spinal syringomyelia (PSS), a subarachnoid block~     effectively shortens the spinal subarachnoid space, reducing CSF compliance and the capacity~     of the spinal theca to dampen the subarachnoid CSF pressure waves produced by the brain~     expansion during cardiac systole; the exaggerated spinal subarachnoid pressure waves occur~     with every heartbeat and act on the spinal cord above the block to drive CSF into the spinal~     cord and create a syrinx. Presyringomyelia, a recently described state of spinal cord edema~     associated with progressive myelopathy and obstruction in CSF flow, is a precursor stage to~     syringomyelia that is consistent with this hypothesis. Because of the importance of this~     condition to the pathophysiology of syringomyelia, we will also study patients with~     presyringomyelia in this protocol. After a syrinx is formed, the enlarged subarachnoid~     pressure waves compress the external surface of the spinal cord, propel the syrinx fluid, and~     promote syrinx progression.~      Many neurosurgeons at prominent academic centers routinely use syrinx shunts to treat~     primarily spinal syringomyelia. This study should provide data that a surgical procedure that~     opens the spinal subarachnoid space corrects the underlying pathophysiology and resolves the~     syrinx and that invasion of the spinal cord is unnecessary.~   "
273242|NCT00011154|"~     Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a fatal~     neurodegenerative disease that poses a significant burden for affected individuals and their~     family members. The principal objective of this epidemiologic study is to identify~     environmental and genetic risk factors for ALS. Of primary interest is whether environmental~     chemicals such as heavy metals, pesticides and organic solvents contribute to the cause of~     ALS. We also aim to identify genetic factors that contribute to the risk of ALS because~     individuals with certain genetic traits may be unable to protect against the toxic effects of~     chemical exposure. Other factors that may protect against the development of ALS, such as~     dietary antioxidants, are also under investigation. If modifiable factors affecting the risk~     for ALS could be identified, interventions to delay or even prevent the development of ALS~     could be developed.~   "
273243|NCT00011141|"~     The etiology of immune-mediated diabetes mellitus (IMD) remains unclear. However, previous~     studies indicate that autoimmunity may be a result of dysfunction of natural killer T cells~     (NK-T cells). Newly diagnoses patients with IMD have been shown in our laboratory to have~     significantly lower NK-T cells than normal controls. Other studies have shown that oral~     administration of lactobacillus can boost NK-T cell activity in children with HIV without~     side effects. Our objective is to evaluate the effect of lactobacillus administration on NK-T~     cell activity in patients with IMD~   "
273244|NCT00011206|"~     To extend mortality followup through 25 years for two cohorts of men in the Multiple Risk~     Factor intervention Trial (MRFIT): the 361,662 men screened and the 12,866 men randomized,~     and to pursue the general aim of elucidating unresolved research issues on the epidemiology,~     natural history, etiology, prevention, and control of major chronic diseases, particularly~     cardiovascular and neoplastic diseases and diabetes.~   "
273245|NCT00011193|"~     To investigate the effects of different amounts of exercise on both cardiorespiratory fitness~     and risk factors for cardiovascular disease in sedentary, overweight, mildly hypertensive,~     but healthy, postmenopausal women aged 45 to 75 years.~   "
273246|NCT00011180|"~     To evaluate the trends in the incidence of venous thromboembolism, to determine the risk~     factors for venous thromboembolism in patients with medical and surgical illness, and to~     evaluate the efficacy of the anticoagulant therapy in reducing venous thromboembolism.~   "
273247|NCT00011167|"~     To determine whether retinal arteriolar changes (generalized narrowing, focal narrowing and~     arterio-venous nicking) and retinopathy were associated with 10-year stroke-and ischemic~     heart disease-related mortality.~   "
273248|NCT00011076|"~     This study will examine the effectiveness of the drug pirfenidone (Deskar) in improving heart~     function in patients with hypertrophic cardiomyopathy (HCM). Stiffening of the heart muscle~     in patients with HCM impairs the heart's ability to relax and thus fill and empty properly.~     This can lead to heart failure, breathlessness and excessive fatigue. The heart's inability~     to relax may be due to scarring, or fibrosis, in the muscle wall. This study will test~     whether pirfenidone can reduce fibrosis, improve heart relaxation and reduce abnormal heart~     rhythms.~      Men and women 20 to 75 years old with HCM may be eligible for this study. Participants will~     undergo a physical examination, blood tests, and other tests and procedures, described below,~     to assess heart function. When the tests are completed, patients will be randomly assigned to~     one of two treatment groups. One group will take a pirfenidone capsule and the other will~     take a placebo (a look-alike pill with no active ingredient) twice a day with meals for 6~     months. For the pirfenidone group, the dose of drug will be increased gradually from 400 to~     800 milligrams. At the end of 6 months, all patients will repeat the physical examination and~     heart tests that were done before starting medication. These include:~        -  Electrocardiogram (ECG) - electrodes are attached to the heart to record the heart's~          electrical activity, providing information on the heartbeat.~        -  Echocardiogram - a probe held against the chest wall uses sound waves to produce images~          of the heart, providing information on the function of the heart chambers.~        -  24-hour Holter monitor - a 24-hour recording of the electrical activity of the heart~          monitors for abnormal heartbeats or conduction abnormalities.~        -  Magnetic resonance imaging (MRI) - Radiowaves and a strong magnetic field are used to~          produce images of the heart, providing information on the thickness and movement of the~          heart muscle.~        -  Radionuclide angiogram - a radioactive tracer is injected into a vein and a special~          camera is used to scan the heart, providing information on the beating motion of the~          heart. Scans are obtained at rest and after exercise.~        -  Cardiac (heart) catheterization - a catheter (thin plastic tube) is inserted into a~          blood vessel in the groin and advanced to the heart to record pressures and take~          pictures inside the heart.~        -  Electrophysiology study - a catheter is inserted into a blood vessel in the groin and~          advanced to the heart to record electrical activity, providing information on abnormal~          heart rhythms. This procedure is done at the time of the heart catheterization.~        -  Cardiac biopsy - a catheter is inserted into a blood vessel in the groin and advanced to~          the heart to remove a small sample of heart muscle for microscopic examination. This~          procedure is done at the end of the heart catheterization.~   "
273249|NCT00011115|"~     This study tests the effects of emphasizing different motivations for wanting to lose weight~     on weight loss maintenance in women. At the start of the study, participants will be weighed~     and will complete questionnaires about their health, weight history, eating and exercise~     habits, body satisfaction and mood. Participants will then be randomly assigned to 1 of 4~     treatments. Participants in all 4 groups will receive information on topics related to eating~     and exercise, and will receive calorie and fat intake goals, and exercise goals. The 4~     treatments will differ in the emphasis given to various reasons for wanting to lose weight.~     At 6, 12 and 18 months after enrollment, participants will again have weights measured and~     fill out questionnaires.~   "
273250|NCT00011102|"~     The purpose of this study is to test methods for preventing weight gain in normal-weight and~     overweight women aged 25 through 44. Participants will complete brief questionnaires about~     their health, eating and exercise habits, and use of weight control strategies. They will~     then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive~     information on the importance of maintaining a healthy body weight, the components of a~     healthy diet, and ways to increase activity levels. The 3 treatment differ in how this~     information is delivered. At 12, 24 and 36 months after enrolling in the study, participants~     will attend assessment sessions. They will complete questionnaires and have body weight~     measured.~   "
273251|NCT00011024|"~     We propose to identify patients and families for inclusion in pilot studies of the three~     modalities. Patients and their families will be asked to participate in these studies.~      Our research group has done some preliminary work with the modality of hypnotherapy, but has~     no experience to date with the other two modalities. The idea to try relaxation techniques~     was generated by the observation that there is great variation in the degree to spasticity at~     different times in the same patient with CP. When queried, mothers responded that they were~     able to get their child to relax and decrease the tension in their muscles by stroking,~     talking softly, and/or by playing certain types of music. The availability of hypnosis and~     training in self-hypnosis was presented to several families of our patients. Their~     understanding and acceptance of this alternate therapy was gratifying. The results of this~     therapy have been promising and have encouraged us to proceed with this modality and to~     consider making other nonconventional modalities available to our patients.~      We hypothesize that at least one of the two modalities will be accepted readily by patients~     with CP and their families, and with their acceptance compliance with the method chosen will~     be at levels of 80 percent or more.~   "
273252|NCT00010998|"~     Changes in visual attention are common among elders and people with multiple sclerosis. The~     visual attention changes contribute to difficulty with day to day functioning including~     falls, driving and even finding one's keys on the kitchen counter as well as contributing to~     deficits in other cognitive domains. Yoga emphasizes the ability to focus attention and there~     is some evidence that the practice of yoga may improve one's cognitive abilities.~     Additionally, yoga practice may improve cognitive function through other non-specific means~     such as improved mood, decreased stress or declines in oxidative injury. We propose a~     randomized, controlled 6 month phase II trial of yoga in two separate cohorts: healthy elders~     and subjects with mild multiple sclerosis. We will determine if yoga intervention produces~     improvements on a broad attentional battery that especially emphasizes attentional control.~     To further understand the reported beneficial effect of yoga on its practitioners, we will~     also determine if there is a positive impact on measures directly related to yoga practice~     (flexibility and balance) as well as mood, quality of life and oxidative injury markers. The~     yoga intervention consists of a Hatha yoga class meeting twice per week. The class is taught~     by experienced yoga teachers who are supervised by a nationally known yoga instructor. There~     are two control groups. An exercise group will have a structured walking program prescribed~     by a certified Health and Fitness Instructor and Personal Trainer. The program will attempt~     to match the Hatha yoga class for metabolic demand. The second control group will be assigned~     to a 6 month waiting list. The outcome measures are assessed at baseline and after the 6~     month period. The primary outcome measures are alertness (quantitative EEG and self-rated~     scale), ability to focus attention (Stroop) and ability to shift attention (extradimensional~     set shifting task). Secondary attention outcome measures include the ability to sustain~     attention (decrement in reaction time) and ability to divide attention (Useful Field of~     View). Other secondary outcome measures include flexibility, balance, mood, quality of life,~     fatigue (in MS cohort) and decreased markers of lipid, protein, and DNA oxidative injury.~   "
273253|NCT00010985|"~     This study compares two approaches to the management of acute low back pain: usual care~     (standard benefit) vs. the choice of: usual care, chiropractic, acupuncture or massage~     therapy (expanded benefit). 480 subjects with uncomplicated, acute low back pain will be~     recruited from a health maintenance organization, and randomized to either usual care (n=160)~     or choice of expanded benefits (n=320). Patients' preferences for individual therapies and~     expectations of improvement will be measured at baseline and throughout the study. Subjects~     randomized to the expanded benefits arm who choose chiropractic, acupuncture or massage will~     receive up to 10 treatments over a five-week period. Additional treatments will be available~     after the fifth week but will require a copayment. Treatments will be provided by licensed~     providers who have met strict credentialing criteria. Chiropractic, acupuncture or massage~     treatments will begin within 48 hours. Chiropractic, acupuncture and massage therapy scope of~     practice guidelines for the treatment of acute low back pain have been developed as have~     detailed data tracking procedures to be used at each patient visit. Symptom relief,~     functional status, restricted activity days, use of health care, and patient and provider~     satisfaction will be assessed at 2, 5,12, 26 and 52 weeks after initiation of treatment.~     Primary outcomes will include: 1) change in symptoms; 2) change in functional status; 3)~     patient satisfaction; and 4) total utilization of services associated with care for low back~     pain. Medical records and the HMO's cost management information system will identify use of~     services. It is hypothesized that patients offered their choice of expanded benefits will~     experience a more rapid improvement in symptoms, a faster return to baseline functional~     status, a decrease in utilization of conventional medical services, and will be more~     satisfied with their care. The study is a direct examination of the effectiveness of an~     insurance eligibility intervention, not a test of the efficacy of specific, non-allopathic~     treatment regimens. The results of this study will provide valuable information to~     clinicians, patients and third party payers on the relative benefits and costs of an~     expanded benefits treatment option which incorporates chiropractic, acupuncture and massage~     services for low back pain.~   "
273254|NCT00010972|"~     This study is testing the safety and effectiveness of acupuncture in controlling pain related~     to the removal of partially impacted mandibular third molars. Acupuncture is the Chinese art~     of healing by inserting needles into the skin.~      Participants ages 18 - 40 are given an initial x-ray to determine if one lower molar is~     partially bony impacted. Eligible participants will then undergo standard oral surgery to~     remove the impacted molar. A local anesthetic will be used prior to surgery. Directly after~     surgery the participant will be assigned to one of three groups. Participants will not be~     able to select which group they are assigned. Participants will receive either real or sham~     (fake) acupuncture as a treatment for post-extraction pain. After the initial acupuncture~     treatment, participants are required to remain for six hours at the dental site to be~     monitored. If a participants discomfort is measured as moderate or higher then a second~     acupuncture treatment will be administered. All participants will be administered~     questionnaires during the day of surgery. Participants will also be required to complete two~     diaries during the seven days following surgery. On the seventh day, participants return to~     have stitches removed and hand in completed diaries.~   "
273255|NCT00010959|"~     This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense~     (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose~     of one botanical preparation. The observation period will be one week. Drug toxicity,~     absorption, distribution, metabolism and elimination data will be collected, and dosages to~     be utilized in a Phase II clinical trial will be determined.~   "
273256|NCT00010946|"~     The goal of this research is to determine the efficacy and safety of Traditional Chinese~     Acupuncture (TCA) in patients with osteoarthritis of the knee. A three arm randomized~     controlled trial (RCT) using sham TCA, true TCA, and an education/attention comparison group~     with a total sample of 525 is proposed. Primary hypothesis to be tested is that patients~     randomized to true TCA will have significantly more improvement in pain and function as~     measured by the Womac Pain & Function Scales and patient global assessments than patients~     randomized to the sham acupuncture and education/attention control groups.~      Secondary aims of the study are to 1) determine if improvement with TCA differs between~     patients below age 65 vs. those aged 65 and above, 2) to determine if improvement with TCA~     differs by racial/ethnic group (ie., Caucasian, Black, Hispanic), and 3) to determine if~     improvement with TCA differs by stage of radiographic severity of knee OA at baseline (KL~     grade 2, 3 or 4)~   "
273314|NCT00008814|"~     The study proposes to evaluate cognitive development in infants four months or younger by~     functional MRI and event related potential recording. fMRI imaging will be obtained following~     an auditory stimulus inside the 4 tesla magnet at the Center for Magnetic Resonance Research~     and will be correlated with ERP response to the same stimulus.~   "
273257|NCT00010933|"~     The purpose of this study is to investigate novel methods from CAM aimed at alleviating~     chronic pain related to functional bowel disorders in children. To that end, two CAM~     modalities will be investigated independently of each other, namely Guided Imagery and the~     use of Chamomile teas as a form of botanical therapy.~      Functional abdominal pain is defined as pain unrelated to an identifiable organic~     gastrointestinal disorder. The two subcategories of functional bowel disorders examined by~     this study will be RAP and IBS. The definition of RAP in children will follow Apley's classic~     definition of paroxysmal abdominal pain occurring in children between the ages of 4 and 16~     years that persists for more than three months, with a frequency of three or more episodes of~     abdominal pain over a three month interval. A similar pattern of abdominal pain relieved by~     defecation and/or associated with altered bowel habits and/or stool consistency will be~     defined as IBS. Despite the above definitions, note that the typical frequency of pain~     episodes associated with functional bowel disorders is at least three times per month.~   "
273258|NCT00010920|"~     Preventing dementia is an important goal for our aging population. This proposal is an~     initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on~     preventing or delaying cognitive decline in people age 85 years or older (the oldest old).~     The study focuses on the oldest old who present a distinct advantage for primary prevention~     studies because of their particularly high risk for developing mild cognitive impairment~     (MCI), a precursor to dementia. Because this is a population that has previously been out of~     the mainstream for use of alternative medicine, the safety of GBE in this age group will also~     be tested in this study. The study is randomized, placebo controlled and double blind.~     Approximately 200 elderly cognitively healthy subjects will be enrolled and followed for~     detection of conversion to MCI. This pilot study is viewed as a necessary first step in order~     to demonstrate that GBE, an alternative or complementary therapy, has a disease modifying~     effect on the brain, distinct from a symptomatic effect. The study will test the feasibility~     of the randomized start design, a trial design proposed as a method for discerning brain- or~     disease- modifying from symptomatic effects. The magnitude of biological effect of the~     treatments will also be assessed with volumetric quantitative MRI, a complementary means of~     confirming whether there is a brain modifying effect (measured as a decrease in brain volume~     loss with treatment). Peripheral markers of oxidation status will measure possible~     anti-oxidant effects of GBE.~   "
273259|NCT00010907|"~     This research will determine whether the Chinese herbal medicine (NPI-028) can make a~     significant contribution to the management of withdrawal and to follow-up treatment aimed at~     preventing or managing relapse in both women and men alcoholics. The herbal preparation has~     been used historically in the treatment of alcohol intoxication and is still prescribed in~     China and Southeast Asia. Efficacy has been documented but awaits the application of current~     research methods to establish efficacy, safety, and probable mechanisms of action.~     Preclinical studies have been carried out in alcohol-preferring rats and vervet monkeys to~     test efficacy in reducing voluntary alcohol intake, measure tolerance effects, and~     toxicological affects. The proposed human trial will develop a placebo, establish quality~     control, test methods of administration, and examine compliance issues. Following these~     preliminary steps, a placebo controlled trial will be conducted using 160 subjects (80~     subjects per treatment condition with 40 of each gender). Alcohol use, craving, health~     status, psychological status, and at rates will be assessed using established measures that~     are current in addiction research.~   "
273260|NCT00010881|"~     The mission of the Oregon Center for Complementary and Alternative Medicine in Neurological~     Disorders (ORCCAMIND) is to facilitate research and education on the effectiveness and~     mechanisms of action of complementary and alternative medicine (CAM) therapies in the~     treatment of neurological disorders. The integration of conventional medicine and CAM~     communities is critical for the success of ORCCAMIND. Thus, ORCCAMIND is composed of six~     institutions: Oregon Health Sciences University; National College of Naturopathic Medicine;~     Western States Chiropractic College; Oregon College of Oriental Medicine; the Linus Pauling~     Institute at Oregon State University; and the Portland Veterans Affairs Medical Center.~      ORCCAMIND will initially focus on the use of CAM antioxidants and stress reduction as~     treatments for neurodegenerative and demyelinating diseases because many of these diseases~     have oxidative injury as a causative or contributory factor and several CAM approaches have~     direct or indirect anti-oxidant effects. Through the Career Development Program the~     Developmental Research Program and the activities of the Education and Information Core, we~     will also foster and promote research into other CAM approaches for neurologic diseases that~     extend beyond anti-oxidant therapies. ORCCAMIND will achieve its goals by carrying out 4~     Research Projects and maintaining 4 Core facilities that integrate the research strengths of~     conventional medicine and CAM practitioners and researchers. ORCCAMIND draws its strength~     from the multi-institutional support and the quality of all its investigators. The~     investigators join ORCCCAMIND with extensive experience with clinical trials, patient care,~     externally funded basic and clinical neuroscience research, and training programs, including~     federally-funded training grants. ORCCAMIND is a bold initiative that integrates basic and~     clinical research scientists, conventional neurologists and CAM practitioners. It will~     promote the exploration of new areas of CAM research and lead research on CAM therapies for~     neurological disorders.~   "
273261|NCT00010868|"~     This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a~     12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3~     fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary~     prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4~     weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication~     will be permitted) will also be stable and at accepted therapeutic levels for at least 4~     weeks. An 8-week lead-in phase will be available to subjects who do not meet the current~     symptom and concomitant medication inclusion criteria (however, subjects must meet all of the~     other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects~     who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic~     medications.~   "
273315|NCT00008801|"~     The broad, long-term goal of this proposal is to improve the results and applicability of~     islet allotransplantation early in the course of type 1 diabetes through the administration~     of selective and short-term immunotherapy. More specifically, the objectives of these studies~     is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical~     and type 1 diabetes to determine the safety, tolerability, immune activity, and~     pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune~     destruction and rejection of allogeneic islet transplants.~   "
273316|NCT00008788|"~     This pilot project aims to 1) estimate the prevalence of osteoporosis in adults having~     undergone liver transplantation in childhood, and 2) identify risk factors for osteoporosis~     in this group. We aim to study 40 individuals.~   "
273349|NCT00007410|"~     To determine the effects of six genes on thrombotic risk factors known to be associated with~     the development of heart disease.~   "
273350|NCT00007397|"~     To relate cardiovascular disease (CHD) risk factors to cognitive performance among~     middle-aged and elderly men and women over a 10 year longitudinal study period.~   "
273262|NCT00010855|"~     Analgesics and sedatives administered to control distress from minimally invasive surgical~     procedures have limited effectiveness and serious side effects. Unabated distress not only~     interferes with smooth progression of the ongoing procedure, but can elicit adverse responses~     when patients need additional intervention. The long-term objective of this research is to~     provide a safe and practical behavioral method for reducing cognitive and physiologic~     distress associated with invasive procedures. Currently, this method should benefit at least~     8 million patients annually in the US. Extrapolating the risk of intravenous conscious~     sedation to the number of invasive procedures performed annually, we predict that 47,000~     patients will suffer serious cardiorespiratory complications and 2,600 will die. These~     numbers do not include effects of the psychological damage inflicted by poorly managed~     procedure-related stress on patients' subsequent health behavior. This application sets out~     to pursue three aims: 1) Prospectively determine the impact of self-hypnotic relaxation on~     cognitive and physiologic distress during tumor embolizations; 2) Prospectively determine the~     impact of self-hypnotic relaxation on distress in the postoperative period; 3) Determine the~     impact of intraprocedural self-hypnotic relaxation on distress during subsequent tumor~     embolization. We hypothesize that: 1) Self-hypnotic relaxation decreases cognitive and~     physiologic distress during tumor embolizations. 2) Self-hypnotic relaxation decreases~     cognitive and physiologic distress after tumor embolization when post-embolization ischemia~     is expected to induce painful stimuli and systemic distress. 3) The beneficial effect of~     self-hypnotic coping skills acquired during an invasive procedure carries over to the next~     invasive procedure. Upon completion, the efficacy and durability of procedural administration~     of nonpharmacologic analgesia will be known by a rigorous and practical assessment. The~     relative performance of self-hypnotic relaxation will be quantified compared to standard care~     and empathic controls in a well-characterized population of patients within the controlled~     and monitored environment of a busy interventional radiology practice. Results from this~     competing renewal will provide the next level of data needed for future study design to~     determine broad clinical utility in a multicenter randomized controlled trial.~   "
273263|NCT00010842|"~     The purpose of this study is to compare the effectiveness of three antioxidant regimens in~     treating the symptoms of multiple sclerosis (MS).~   "
273264|NCT00010829|"~     This study will assess whether alternative, high phytoestrogen dietary interventions result~     in favorable effects on biological parameters that have been associated with~     hormone-dependent cancers, cardiovascular disease, and osteoporosis.~   "
273265|NCT00010816|"~     Hepatitis C (HCV) is a chronic viral illness leading to progressive liver damage that has~     emerged as a major public health issue in the United States. While HCV affects all population~     groups, individuals with a history of intravenous drug use form the largest known risk group.~     Between 90 and 100 percent of long term intravenous drug use will eventually test positive~     for HCV, and there is substantial risk that even short term experimentation will result in~     infection. Studies suggest that HCV will be the major cause of cirrhosis and liver cancer in~     the next century. Currently, approved therapy includes recombinant interferons, which lead to~     sustained remission in a minority of patients. However, patients abusing other substances,~     including alcohol, are not eligible for interferon therapy. The need for investigation into~     other potential therapies is clear. Current practice patterns in the Far East include the use~     of traditional herbal remedies for symptomatic chronic viral hepatitis. This study is~     intended to examine the effect of commonly used herbal remedies for the treatment of~     symptomatic HCV.~   "
273266|NCT00010803|"~     This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence~     of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and~     functional disability, reducing incidence of cardiovascular disease, and decreasing total~     mortality.~   "
273267|NCT00010777|"~     The goal of this proposal is to evaluate the efficacy of a multiple component mind-body~     (MCMB) therapy for fibromyalgia, both in short and long term outcomes. Preliminary work~     suggests that FM patients do benefit from MCMB therapy (Singh et al 1998; Creamer et al~     1998). This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB~     intervention or a 12 week education/attention intervention. The primary aims of this study~     are 1) to determine if a 12 week MCMB intervention improves short term (i.e. at 12 weeks)~     outcomes in FM patients compared to an education/attention control group; and 2) to determine~     if a 12 week MCMB intervention improves long term (i.e. at 24 weeks) outcomes in FM patients~     compared to an education/attention control group.~      A secondary aim of this project involves determining if there are patient characteristics~     (i.e. disease severity and duration, demographics, psychological factors) associated with~     improvements in short or long term outcomes as well as responses to the MCMB intervention.~      The primary outcome measure will include physical functioning and pain as measured by the~     Fibromyalgia Impact Questionnaire.~   "
273268|NCT00010764|"~     Fibromyalgia (FM), one of the most common rheumatic conditions, is a condition of unknown~     etiology characterized by widespread muscle pain and stiffness. Treatment is generally~     unsatisfactory and most randomized, controlled treatment trials have been unable to~     demonstrate a sustained effective intervention. A single, brief trial of electroacupuncture~     demonstrated remarkable improvement among patients with FM, although lasting effects were not~     evaluated. Nonetheless, the recently published National Institutes of Health Consensus~     Development Statement on Acupuncture says musculoskeletal conditions such as fibromyalgia,~     myofascial pain ....are conditions for which acupuncture may be beneficial. Thus, 96~     patients will be recruited from a referral clinic for fatigue for a 12 week (24 treatments)~     trial. These patients will be randomized into 3 control groups and 1 true acupuncture~     group. The control groups will consist of a group receiving acupuncture treatment for an~     unrelated condition (morning sickness), a group receiving needle insertion at non-channel,~     non-point locations, and a true placebo group. This latter group will have acupuncture~     needle guides tapped on the skin, then needles tapped. Thus, the specific aims of this study~     are to 1) evaluate the short and long term efficacy and side effects of a 12 week randomized,~     controlled trial of bi-weekly acupuncture in the treatment of FM; 2) establish the most~     useful and scientifically sound control group for studies of acupuncture using FM as a model~     for conditions characterized by chronic pain; 3) use both subjective and objective measures~     of overall health and pain to determine the optimal time length of treatment; and 4) examine~     the concordance of allopathic and acupuncture-based measures of outcome. For the purposes of~     this study, subjects will be asked to complete a unique set of study measures at enrollment,~     at 4, 8, and 12 weeks, and then again at 1 and 6 months post-treatment. Our primary outcomes~     will be patient global assessment, subjective pain, and mean number of tender points.~     Secondary outcomes will be pain threshold, analgesic use, physician global assessment,~     functional status, sleep, psychological distress, and fatigue. Thus, this trial will have~     both immediate and longer term implications for the scientific study of acupuncture as well~     as the clinical care of the estimated 5 million patients with FM in the US. From a~     methodological point of view, the proposed trial will establish the most appropriate methods~     for choosing a control group should larger trials be conducted, suggest the optimum duration~     of treatment, and evaluate the utility of diverse allopathic and alternative outcome~     measures. Of equal importance, however, this research will test and potentially establish the~     effectiveness of acupuncture.~   "
273269|NCT00010751|"~     The object of this study is to determine if Reiki will improve glycemic control and cardiac~     autonomic function diabetic patients with painful neuropathy.~   "
273270|NCT00010738|"~     To study the effects of Transcendental Meditation on Coronary Heart Disease~   "
273271|NCT00010725|"~     The purpose of this study is to compare an herbal supplement, nonfood-derived vitamins, and~     placebo for the care of cardiovascular disease in high risk older African Americans.~   "
273272|NCT00010712|"~     This study will assess whether treatment with black cohosh is effective in reducing the~     frequency and intensity of menopausal hot flashes. In addition, this study will determine~     whether or not black cohosh reduces the frequency of other menopausal symptoms and improves~     quality of life.~   "
274059|NCT00005212|"~     To determine the combined effects of job strain and social isolation on cardiovascular~     morbidity and mortality.~   "
273280|NCT00010504|"~     Fibromyalgia is the second most common rheumatic disorder, affecting approximately 8-10~     million persons in the U.S., and is characterized by widespread musculoskeletal pain and soft~     tissue tenderness upon examination. This study focuses on the use of acupuncture as a mode of~     therapy for fibromyalgia. The issues under examination are: 1) the optimal duration of~     treatment, 2) the independent and synergistic effects of needle placement and needle~     stimulation, and 3) appropriate control strategies. The proposal utilizes a randomized,~     blinded, sham-controlled design to achieve these aims. Subjects are randomly assigned to one~     of four groups: 1)active site with stimulation, 2) active site, without stimulation, 3) sham~     site with stimulation, and 4) sham site, without stimulation. All subjects will receive~     acupuncture at escalating frequency, beginning at once per week and ending at 3 times per~     week. This forced titration design allows for the detection of inter-subject differences in~     responsiveness to acupuncture, as well as the factors which may predict responsiveness (or~     lack thereof). Secondary goals of the study are to collect data on the mechanism, safety, and~     cost-effectiveness of acupuncture in fibromyalgia, and to determine the optimal outcome~     measures, for a full scale research clinical trial.~   "
273281|NCT00010491|"~     The objective of this study is to test alternative treatment strategies to reduce the~     frequency of chronic diarrhea among HIV positive individuals. 60 percent of patients with HIV~     disease in the U.S. will have diarrhea at some point in their illness. Although in general~     many of the opportunistic infections (OI's) associated with HIV have decreased due to new~     drug cocktails, many of these drugs, however, have diarrhea as a side effect. In Asian~     countries, acupuncture (including moxibustion) has been widely used for the treatment of~     various gastrointestinal (GI) disorders. However, there are no published studies that test~     treatment protocols using acupuncture or moxibustion on patients with HIV experiencing~     chronic diarrhea.~   "
273282|NCT00010478|"~     Although traditional Chinese medicine advocates the use of acupuncture not only to induce~     analgesia but also to treat essential hypertension, acupuncture's postulated antihypertensive~     efficacy in humans has not been subjected to rigorous Western scientific testing. Before~     advocating acupuncture as an effective complementary/alternative medicine strategy for~     essential hypertension, it is necessary to demonstrate that the beneficial effects of~     acupuncture are scientifically robust, long-lasting, and explicable in terms of modern~     scientific mechanisms. In spontaneously hypertensive rats, acupuncture-like electrical~     stimulation of thinly myelinated (Group III) somatic afferents activates central endorphin~     (naloxone-sensitive) pathways that elicit long-lasting decreases in sympathetic nerve~     activity (SNA) and blood pressure. The ability to record SNA with microelectrodes in~     conscious humans provides a new opportunity to test this novel mechanistic hypothesis in~     patients undergoing electroacupuncture, a modification of the ancient technique that provides~     a quantifiable and reproducible stimulus to human skeletal muscle afferents. Using a~     randomized, double-blind placebo-controlled design, we will test the following major~     hypotheses: Electroacupuncture produces a long-lasting reduction in SNA, thereby providing a~     safe and effective complementary treatment of human hypertension. Given the enormous interest~     in acupuncture by our lay public, but the paucity of Western scientific data about its~     efficacy in cardiovascular disorders, our studies in normotensive and hypertensive humans~     should provide a conceptual framework for deciding whether to accept or reject the large body~     of Chinese (and Russian) literature advocating acupuncture as a safe and effective treatment~     of essential hypertension and other cardiovascular disorders (such as heart failure, and~     myocardial ischemia).~   "
273283|NCT00010465|"~     The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic~     manipulation for the prevention of further ear infections in children with recurrent ear~     infections (otitis media).~   "
273284|NCT00009685|"~     This study will test the safety of an experimental vaccine against HIV and will examine~     whether it causes an immune response to HIV virus proteins. A vaccine is given to try to~     create resistance or immunity to a disease or infection. The vaccine in this study is made~     from DNA (genetic material) of two HIV proteins called gag and pol. Injected into a~     human, the viral DNA instructs the body to make small amounts of some HIV proteins. This~     study will see if the body then creates an immune response to these proteins. Study~     participants cannot catch HIV or AIDS from the DNA vaccine or proteins that may be made from~     it.~      Healthy normal volunteers between 18 and 60 years of age may be eligible for this study.~     Candidates will provide a medical history, including information on sexual activity and drug~     use. They will have a physical examination, blood tests, urine test and chest X-ray. All~     candidates enrolled in the study must use a barrier method of contraception for sexual~     intercourse from the start of the study until 3 months after the last vaccination.~      Participants will be assigned to one of two treatment groups: one will receive the~     experimental vaccine; the other will receive a control substance (inactive salt solution).~     The first five people assigned to the vaccine group will receive the lowest study dose of the~     vaccine. If this dose is safe, it will be increased three times for the next group of five~     and then eight times for the last group of five. Each group will have a total of seven people~     - five will receive the vaccine and two will get the salt solution.~      Before the first injection, and possibly the second and third, a catheter (thin plastic tube)~     will be placed into a vein so that treatment can be given quickly if there is a reaction to~     the vaccine. Participants will receive three injections in an upper arm muscle-one injection~     a month for three months-with a needle-less device called a Biojector. For each injection,~     the volunteer will~        -  be observed for at least 1 hour after immunization~        -  record temperature and symptoms, including any effects at the injection site, for 2 days~          and report them to the clinic staff~        -  immediately report any side effects to a study physician or nurse.~      Volunteers will have physical examinations and laboratory tests at certain times while they~     receive the vaccine and for a period afterwards. These procedures will require about 14~     clinic visits of about 1 to 2 hours each, and up to 6 hours on vaccination days. Blood will~     be drawn at all visits. Some of the blood will be used for genetic tests, and some will be~     stored for future tests of the immune system and the body's response to the study vaccine.~     The study will last about 12 months from the date of the first injection. After it is~     completed, clinic staff may contact volunteers once or twice a year for at least 3 years to~     follow up.~   "
273285|NCT00009672|"~     This study will test the effectiveness of two drugs-nortriptyline and MS Contin (a type of~     morphine)-to treat pain caused by lumbar radiculopathy, or sciatica. Sciatica results from~     damage to the lumbar nerve roots, typically causing back pain and sharp, shooting pain down~     one or both legs. Although sciatica is common, there are no good treatments for it. Tricyclic~     antidepressants, such as nortriptyline, and opioids, such as morphine, have been effective in~     treating other kinds of pain from nerve damage.~      Patients between 18 and 65 years of age who have had sciatica pain daily for at least 3~     months may be eligible for this study.~      Participants will provide a medical history and occupational and other social information.~     They will undergo a neurological examination, routine blood tests and an electrocardiogram~     and will fill out three questionnaires providing information on daily functioning and~     psychological well-being.~      This cross-over study consists of several parts, including a baseline study and four~     different treatment regimens. During each part, patients keep a daily log in which they rate~     their pain, record other procedures they undergo, such as injections and manipulations, and~     record medication side effects.~      In the first week of the study, patients remain on their current medications. Any~     antidepressants or opioids are stopped gradually before starting the drug trials. After the~     first week, patients go through the following four drug trials in random order:~        1. Nortriptyline and inert placebo-Patients take nortriptyline in doses ranging from 25 mg.~          to 100 mg. and an inert placebo for morphine. (An inert placebo is a dummy pill; it~          looks like the test drug but has no active ingredient.)~        2. MS Contin (morphine) and inert placebo-Patients take MS Contin in doses ranging from 30~          mg. to 90 mg. and an inert placebo for nortriptyline.~        3. Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose~          ranges as for each drug alone.~        4. Active placebo and inactive placebo-Patients take an active placebo-in this case~          benztropine-and an inert placebo. An active placebo is a drug that does not work for the~          problem being studied but whose side effects are like those of the test drug-in this~          case, slight sleepiness or dry mouth. Benztropine is given at one-third the recommended~          dosage.~      For each drug regimen, the medication dose is increased gradually over 5 weeks until the~     maximum tolerated dose is reached. At the end of each regimen, patients are taken off the~     study drugs over a 12-day tapering period and are off drugs completely for another 2 days.~      Patients are seen by a doctor or nurse at the 7-week point in each study period. After all~     the drug trials are finished, patients repeat the questionnaires they filled out at the~     beginning of the study. Patients and their doctors will be informed of the medications that~     were effective in each individual's care.~   "
273351|NCT00007384|"~     To longitudinally investigate multigenerational familial clustering of plasma low density~     lipoprotein cholesterol (LDL-C), with particular emphasis on the influences of apoE genotypes~     and various 'behaviors'.~   "
273286|NCT00009659|"~     This study will examine the safety and effectiveness of a synthetic hormone, CDB-2914, for~     treating symptoms of menopause. It will compare the effects of estrogen and CDB-2914 with~     those of estrogen and progesterone in postmenopausal women. The study will also evaluate~     whether CDB-2914 affects adrenal gland function. CDB-2914 is chemically similar to cortisol,~     a hormone that is produced by the adrenal glands and regulates the body's response to~     stresses, such as infection or injury.~      Healthy women volunteers between the ages of 45 and 70 who have not had a menstrual period~     for over a year, are not currently taking hormone replacement therapy, do not smoke and have~     not had a hysterectomy may be eligible for this study. Candidates will provide a medical~     history and have a physical examination, including a breast and pelvic exam. They will also~     provide a blood sample, have a mammogram and pap smear, and be instructed in dietary sources~     and/or supplements required to be sure they consume at least 1,000 mg. of calcium each day.~      Participants will be randomly assigned to take: a) estrogen plus CDB-2914, b) estrogen plus~     progesterone, or c) estrogen plus a placebo (look-alike tablet with no active ingredient)~     daily by mouth for 6 weeks. During the study period, they will keep a record of any symptoms,~     vaginal bleeding, and other medicines they take. They will return to the NIH Clinical Center~     weekly for blood tests and to fill out a questionnaire on mood, appetite, sleep patterns,~     menopausal symptoms, and other quality of life issues. At the 6-week visit, participants~     will:~        -  Bring a 24-hour urine collection~        -  Have a vaginal ultrasound to evaluate the effects of the medication on the thickness of~          the endometrium (lining of the uterus)~        -  Bring all bottles of study medication for a pill count~        -  Discuss any unusual or troubling symptoms with the study nurse or physician~      A final visit will be scheduled 1 to 3 weeks after the 6-week visit, when participants will~     turn in their calendar of daily symptoms and return unused progesterone pills.~   "
273287|NCT00009646|"~     This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999~     grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy~     or developmental problems at 18 to 22 months of age.~   "
273288|NCT00009633|"~     The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which~     surviving extremely low birth-weight infants born in participating network centers receive~     neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age~     (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding~     pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential~     maternal and neonatal risk factors that may affect infant neurodevelopment.~   "
273289|NCT00009620|"~     This large randomized trial tested whether phenobarbital given to a pregnant woman about to~     deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to~     32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were~     randomized to phenobarbital or usual care. They were treated until they deliver or the fetus~     reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos~     corrected age for neurodevelopmental outcome.~   "
273290|NCT00010452|"~     OBJECTIVES:~      I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic~     lymphangioma.~   "
273291|NCT00010439|"~     OBJECTIVES:~      I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral~     density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.~   "
273292|NCT00010426|"~     OBJECTIVES: I. Determine the proportion of patients with cystinosis who experience a serious~     adverse effect when treated with a new formulation of cysteamine hydrochloride for corneal~     cystine accumulation.~      II. Determine the proportion of patients with a reduction in corneal crystal density of 1.00~     unit when treated with this regimen.~   "
273293|NCT00010413|"~     OBJECTIVES:~      I. Determine the response rate and 1-year event-free survival of patients with refractory~     pemphigus treated with high-dose cyclophosphamide.~   "
273294|NCT00010400|"~     OBJECTIVES:~      I. Determine the induction of durable remission in patients with life-threatening systemic~     lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide.~      II. Determine the toxicity of this drug in these patients.~   "
273295|NCT00010387|"~     OBJECTIVES:~      I. Determine the response rate and 1-year event-free survival in patients with severe~     autoimmune hematologic disease treated with high-dose cyclophosphamide.~   "
273296|NCT00010374|"~     OBJECTIVES:~      The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for~     treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The~     hypothesis being tested in the clinical trial is that laparoscopic stimulation of the~     diaphragm at the motor point with intramuscular electrodes is safe and effective in providing~     significant ventilatory support to individuals who are otherwise dependant on a mechanical~     ventilator. Patients in our initial study group have all suffered from high-level spinal cord~     injury and were full-time dependant on positive pressure mechanical ventilation prior to~     inclusion.~   "
273297|NCT00010361|"~     OBJECTIVES: I. Determine the safety of total body irradiation and fludarabine followed by~     allogeneic peripheral blood stem cell or bone marrow transplantation in combination with~     cyclosporine and mycophenolate mofetil for establishing mixed chimerism in patients with~     inherited disorders.~      II. Determine whether this regimen can establish mixed chimerism in these patients.~      III. Determine whether mixed chimerism is sufficient to reverse disease symptoms in these~     patients.~      IV. Determine the safety of donor lymphocyte infusions to eliminate persistent disease in~     these patients with mixed chimerism.~   "
273298|NCT00010335|"~     OBJECTIVES: I. Determine the safety and long term complications of total body irradiation in~     combination with cyclophosphamide, anti-thymocyte globulin, and autologous CD34-selected~     peripheral blood stem cell (PBSC) transplantation in children with refractory autoimmune~     disorders.~      II. Determine the efficacy of this treatment regimen in these patients. III. Determine the~     reconstitution of immunity after autologous CD34-selected PBSC transplantation in these~     patients.~      IV. Determine engraftment of autologous CD34-selected PBSC in these patients.~   "
273317|NCT00008775|"~     Chest physiotherapy is recognized as a mainstay of cystic fibrosis therapy, and is~     particularly important during treatment of pulmonary exacerbations. For some patients,~     especially those with moderate to severe compromise of lung function, this therapy may impose~     a high demand in the work of breathing and energy expenditure. The goal of this study is to~     evaluate the effectiveness of adding pressure support ventilation (PSV) during chest~     physiotherapy sessions in patients with cystic fibrosis with moderate to severe lung function~     compromise being treated for a pulmonary exacerbation.~   "
273662|NCT00005725|"~     To develop and demonstrate the efficacy of a set of original, cardiovascular (CVD) nutrition~     education materials designed to reduce intake of sodium (Na) fat, and cholesterol and which~     would be appropriate for urban Black adults with 5th to 8th grade reading levels.~   "
273663|NCT00005724|"~     To develop cardiovascular disease nutrition modules tailored to subjects with low literacy~     skills.~   "
273299|NCT00009594|"~     Temporomandibular disorders (TMD) are characterized by pain and tenderness in the muscles of~     mastication and/or the temporomandibular joint (TMJ), limitations of jaw opening often~     accompanied by deviations in mandibular path, and clicking, popping or grating TMJ sounds.~      TMD is often found in association with other problems: depression, anxiety, sleep~     disturbances, gastrointestinal symptoms, frequent infections, etc. This project proposes to~     holistically address patient symptoms through three different approaches, Naturopathic~     Medicine (NM), Traditional Chinese Medicine (TCM), and usual care at KPNW. We will conduct a~     pilot test and Phase II trial to evaluate the two alternative healing approaches, TCM (n=50)~     and NM (n=50) delivered by TCM and NM practitioners, are as effective as usual TMD care~     (n=50) provided by dental clinicians in the KPNW TMD Clinic. Subjects will be females 25-55~     years of age with multiple health problems (defined as patients who have had at least 4 organ~     system-grouped diagnoses in the past year, not including TMD). Subjects will be evaluated at~     baseline, 6 and 12 months after start of treatment. The primary endpoint is change from~     baseline in the Axis II Pain Related Disability and Psychological Status Scale. Clinical~     examinations, saliva samples to assess salivary cortisol levels, and responses to a series of~     questionnaires to assess pain, chronic pain, psychosocial functioning, and other physical~     symptoms will be used to assess outcomes. We will passively monitor health care utilization~     within KPNW using clinical, research, and administrative databases to determine whether the~     interventions have an impact on overall health care utilization. If either of these~     alternative interventions is shown to merit Phase III trial, our goal is to design and~     implement such a clinical trial to further evaluate the health consequences and costs of~     these alternative healing paradigms.~   "
273300|NCT00009581|"~     Nitric oxide is important in regulating blood vessel dilation, and consequently, blood flow.~     This gas is continuously produced by cells that line the blood vessels. It is also~     transported from the lungs by hemoglobin in red blood cells. This study will examine how this~     gas regulates blood vessels and blood flow in people with sickle cell anemia. It will also~     look at a possible benefit of using certain genetic information to compare the white blood~     cells of people with sickle cell anemia to those without the disease.~      Patients with sickle cell anemia and healthy normal volunteers 18 to 65 years of age may be~     eligible for this study. Candidates will be screened with a medical history, cardiovascular~     physical examination, electrocardiogram and routine blood tests. Participation of volunteers~     without sickle cell anemia will be limited to a single blood draw for genetic study. Sickle~     cell disease patients will undergo the following procedures:~      Patients will lie in a reclining chair during the study. After administration of a local~     anesthetic, small tubes will be inserted through a needle into the artery and vein of the~     patient's forearm. These are used to measure blood pressure and draw blood samples during the~     study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper~     arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are~     inflated, blood flows into the arm, stretching the strain gauge, and the flow measurement is~     recorded. A small lamp will be positioned over the hand. Light reflected back from the hand~     provides information about nitric oxide and hemoglobin in the blood of the skin. A squeezing~     device called a dynamometer will be used to measure handgrip strength.~      Baseline blood flow, nitric oxide, hemoglobin, and handgrip will be measured after an~     infusion of glucose (sugar) and water. These measurements will be repeated at various times~     before, during and after administration of small doses of the following drugs:~        -  Sodium nitroprusside - causes blood vessels to dilate and increases blood flow to the~          heart~        -  Acetylcholine - causes blood vessels to dilate and slows heart rate~        -  LNMMA - decreases blood flow by blocking the production of nitric oxide~      There will be a 20- to 30-minute rest period between injections of the different drugs.~      When the above tests are completed, the patient will breathe a mixture of room air and nitric~     oxide for 1 hour through a facemask placed over the face, after which forearm blood flow and~     light reflected from the hand will be measured. Then the patient will do the handgrip~     exercise for 5 minutes, after which blood flow and hand lamp measurements will be taken.~     After a 20-minute rest period (with continued breathing of room air/nitric oxide), L-NMMA~     will be infused again. The handgrip exercise, blood flow and hand lamp measurements will be~     repeated. The face mask will then be removed, and the tubes will be removed 20 minutes later.~      Blood samples will be collected at various times during the 5- to 6-hour study through the~     tubes in the arm. Some of the blood will be used to look at genes that make proteins involved~     in cell-to-cell communication, inflammation, and in making red and white blood cells stick to~     the lining of blood vessels.~   "
273301|NCT00009568|"~     This study will examine the effect of a class of antidepressant medications called selective~     serotonin reuptake inhibitors (SSRIs) on platelet function. Platelets are small blood cells~     that help stop bleeding after injury to a blood vessel by forming a clot, or plug, in the~     vessel. Some medications impair platelet function, leading to increased bruising and~     bleeding. SSRIs decrease an important platelet component called serotonin, which may cause~     bleeding in some patients. SSRIs include fluoxetine (Prozac), sertraline (Zoloft), paroxetine~     (Paxil), fluvoxamine (Luvox) and citalopram (Celexa).~      Patients 18 years of age and older being treated for depression with a SSRI or the non-SSRI~     bupropion (Wellbutrin) may be eligible for this study. Subjects will be recruited from a~     private clinic in Washington, D.C.~      Participants will provide a history of their current medications and past history of~     bleeding. They will have about 4 tablespoons of blood drawn for tests to measure blood cell~     counts and platelet function. The study takes about 1 hour. The results of the SSRI-treated~     group and the bupropion-treated group will be analyzed and compared.~      This study may provide information that will help health care providers make treatment~     decisions to minimize possible adverse effects of medications in patients with depression.~   "
273302|NCT00009529|"~     To examine the effects of rigid gas permeable contact lenses on the progression of myopia~     (nearsightedness) in children~      To determine what changes in the eyes cause certain eyes to progress in nearsightedness more~     slowly~   "
273303|NCT00009256|"~     The purpose of this study is to gain knowledge about why drug therapy sometimes stops working~     in people infected with the human immunodeficiency virus (HIV). This occurs in 30 to 40% of~     patients treated with powerful antiretroviral drugs. The study will examine how the virus~     becomes resistant to drug treatment through mutations (changes) and how different mutations~     produce new variants that are resistant to more than one drug.~      HIV-infected patients 18 years and older who have not been treated with antiretroviral~     medications and who have a relatively stable amount of virus in their blood (viral load) may~     be eligible for this study. Pregnant or breastfeeding women may not participate. Candidates~     will be screened with blood tests to determine viral load and to study the genetics of the~     virus.~      Participants will be hospitalized at the NIH Clinical Center for 10 days for daily blood~     sampling. (In exceptional circumstances, the sampling may be done on an outpatient basis.)~     After discharge, patients will be followed by weekly visits for blood tests for a total of~     120 days. When antiretroviral treatment begins, the patient may do one of the following:~        1. Continue on this study with antiretroviral treatment. Therapy will consist of D4T, 3TC,~          and efavirenz. Other drugs may be substituted for any of these that cannot be tolerated.~          HIV protease inhibitors will not be included in the regimen.~        2. Complete participation in this study and, if eligible, enroll in another NIH protocol~          (AVBIO).~        3. Begin standard antiretroviral therapy with a private physician.~      Patients for whom treatment is not yet recommended or who choose not to be treated may~     continue to be monitored with blood tests for a total of 18 months. (Patients who leave the~     study after this time may re-join when they decide to start treatment.)~      Participants may also undergo the following optional procedures to study the genetic~     variation of HIV: lymph node biopsy, spinal tap, and semen donation or female genital washing~     to collect secretion samples.~      Sexual partners or needle-sharing partners of study patients are invited to enroll in this~     study to provide blood samples at the time the patient enrolls and at two intervals after any~     needle sharing or unsafe sex event they may report to NIH. Partners may also donate genital~     secretions or semen, and a lymph node or spinal fluid sample.~      Information from this study may help in the development of new drug treatments that will be~     effective in controlling HIV infection when other treatments no longer work.~   "
273318|NCT00008762|"~     People with cystic fibrosis (CF) now frequently live into adulthood and with this extended~     life expectancy has come new clinical problems. Poor bone health, including osteoporosis and~     bone fractures, is one of these increasingly important conditions. Preventing the negative~     outcomes of poor bone health in later life is primarily related to ensuring optimal growth~     (weight and height) and obtaining maximal amount of bone mass during growth and development.~     This study will identify factors that influence bone health in a sample of children,~     adolescents and young adults as measured by dual energy x-ray absorptiometry and new bone~     densitometry methods (peripheral quantitative computerized tomography [p-QCT] and bone~     sonometer). We will also identify factors which influence changes in bone status over a~     12-month follow-up period in a subsample of people with CF.~   "
273304|NCT00009243|"~     The purpose of this study is to learn more about stroke and obtain information that may serve~     as the basis for future investigations. It will 1) establish a registry of patients with~     cerebrovascular disease (stroke); 2) characterize the natural history of acute stroke and~     transient ischemic attacks (TIA) an interruption of blood flow to the brain that causes~     stroke symptoms for a short period of time); and 3) evaluate the data to generate ideas for~     future studies.~      Patients 18 years of age or older with suspected acute stroke or TIA may be eligible for this~     study. Subjects will be recruited from patients who present with stroke at the emergency~     department of Suburban Hospital in Bethesda, Maryland.~      The study will gather data collected from diagnostic and laboratory tests the patient~     undergoes as part of standard medical care, including findings of medical and neurological~     examinations and other tests. In addition, studies will be done for research purposes only to~     gather data about stroke and TIA. These may include the following:~        -  Blood and urine tests not more than 2 tablespoons of blood will be drawn for various~          tests.~        -  Electrocardiogram (EKG) (heart tracing) electrodes placed on the chest wall detect the~          heartbeat and heart rhythm.~        -  Computed tomography (CT) scan of the head specialized X-rays are used to obtain images~          of the brain.~        -  Magnetic resonance imaging (MRI) of the brain a strong magnetic field and radio waves~          are used to produce images that provide information about the brain tissue and blood~          vessels.~        -  Transcranial Doppler (TCD) sound waves are used to image the arteries of the brain and~          neck.~        -  Echocardiogram sound waves are used to image the heart and evaluate heart function.~      Patients may be asked to return to Suburban Hospital for follow-up testing in 1, 3, and/or 12~     months, when some of these tests may be repeated to assess changes over time~   "
273305|NCT00009230|"~     This project is designed to study whether anti-inflammatory drugs, such as celecoxib, may~     delay age-related mental decline. We are also looking at genetic risk and brain structure as~     potential predictors of mental decline. We believe people with age-associated memory~     impairment who take celecoxib will show less evidence of mental decline than those receiving~     placebo (an inactive pill) after 18 months. We expect that brain structure at the start of~     the study, memory performance as indicated by tests, and age will be additional predictors of~     mental decline. We also predict that cognitive decline (i.e., decline in thinking and memory)~     and treatment response will vary according to genetic factors that may correlate with the age~     at which dementia begins. We believe other variables such as prior educational achievement,~     memory capability at the outset of the study, and gender may influence mental decline and~     treatment response. We will study people with age-associated memory impairment (mild memory~     complaints, decreased performance in selected memory tests), between 40 and 90 years of age.~     The subjects will be randomly (i.e., by a process similar to flipping a coin) assigned to~     treatment groups. The subjects will receive either an inactive substance (placebo) or~     celecoxib (400 mg/day). The subjects will receive a magnetic resonance imaging (MRI) scan,~     FDG PET scan, routine laboratory blood tests, electrocardiogram and cognitive tests. They~     will be followed for approximately 18 months and asked to return at specific intervals for~     follow-up testing. Measures of brain structure will be derived from baseline MRI scans and~     metabolic activity from PET scans, and blood will be drawn and tested to determine which~     forms (genotypes) of certain genetically determined cellular components the patient has.~   "
273306|NCT00009217|"~     The optimal strategy for the treatment of behavioral complications in patients with probable~     Alzheimer's disease (AD) remains unclear.~      The objective of this study is to evaluate the risk of relapse following discontinuation of~     haloperidol in patients with Alzheimer's disease (AD) with psychosis or agitation who respond~     to it.~      In Phase A of this study, AD outpatients with behavioral complications receive 20 weeks of~     open haloperidol treatment with an oral dose of 1-5 mg daily, titrated individually to~     achieve the optimal trade-off between efficacy and side effects. Responders to Phase A~     participate in Phase B, a 24-week continuation trial in which patients are randomized to~     continuation haloperidol or placebo.~      The primary outcome is the time to relapse of psychosis or behavioral disturbance.~   "
273307|NCT00009204|"~     This study is a randomized, double-blind, placebo-controlled, fixed dose study currently~     being conducted on two geropsychiatric units at Western Psychiatric Institute and Clinic. It~     seeks to evaluate the short-term safety and efficacy of citalopram and perphenazine in the~     treatment of 112 patients suffering from behavioral disturbances associated with dementia.~     Findings from this research may directly lead to improved acute pharmacotherapy for psychosis~     and behavioral problems in patients diagnosed with dementia. Improved treatment of behavioral~     complications with reduced side effects would reduce excess disability in patients diagnosed~     with dementia, allowing them to be maintained in the community for greater periods of time.~   "
273308|NCT00009191|"~     Major depression afflicts approximately 25 percent of patients with AD. Depression in AD~     patients leads to mental suffering, behavioral disturbance (such as aggression), poor~     cognition, poor self-care, caregiver depression, caregiver burden, and early entry into the~     nursing home. Since major depression is treatable, this additional disability may be~     avoidable. The use of antidepressants to treat major depression in AD is supported by two~     studies, although a third does not show a benefit for antidepressants over placebo. Also, the~     safety of antidepressant treatment in depressed AD patients is poorly studied. A conclusive~     study showing that depression reduction in AD can be accomplished safely with antidepressant~     medications, and that depression reduction is associated with improvements in activities of~     daily living, non-mood behavioral disturbances, caregiver burden, and caregiver depression~     would have major clinical and cost implications for the care of the AD patient. This study is~     a 13-week, double blind, flexible dose, placebo controlled trial of sertraline in the~     treatment of outpatients with AD and co-morbid major depression. The hypothesis is that~     antidepressant treatment is superior to placebo in improving mood, in improving cognition, in~     reducing physical dependency, in reducing caregiver depression, and in reducing caregiver~     burden. It is also hypothesized that the degree of depression reduction is correlated with~     these improvements. It is further hypothesized that the safety profile of sertraline when~     compared to placebo is acceptable, especially with regard to risk of falls, sleep~     disturbance, and delirium. One hundred community residing outpatients with probable AD who~     also meet DSM-IV criteria for major depressive episode will be recruited into the study. They~     will be randomized to sertraline or placebo and followed through weekly telephone contact by~     an experienced clinical trials team. Outcomes will be assessed every 3 weeks, for a total of~     four followup data points. Scales assessing the following domains will be used: depression,~     cognition, behavioral disturbance, physical dependency, delirium, falls, sleep, other side~     effects, caregiver depression, caregiver burden, caregiver functioning, and caregiver health.~   "
273319|NCT00008749|"~     Systemic lupus erythematosus is an often devastating autoimmune disease which affects 1 in~     2,000 women in the United States. Recently, several research laboratories have reported that~     a protein, named CD40-ligand (CD154), is overexpressed by a subset of white blood cells,~     called lymphocytes, in patients with lupus. Expression of CD154 appears critical to the~     generation of antibodies that cause disease in lupus. Blocking CD154 interactions in the~     immune system has been shown to decrease disease activity in animal models of lupus. We~     propose to study the regulation of CD154 in patients with lupus in hopes of inhibiting its~     abnormal and deleterious expression.~   "
273320|NCT00008736|"~     Serial EGC measurements in premature infants attempting to correlate EGC measurements with~     signs of feeding intolerance and response to metoclopramide therapy.~   "
273664|NCT00005723|"~     To evaluate the impact of organizational-level health promotion activities and worksite~     characteristics on employee dietary and smoking behaviors.~   "
274060|NCT00005211|"~     To assess the risk of cardiovascular mortality in workers with increased occupational~     exposure to carbon monoxide.~   "
273309|NCT00009048|"~     This study will evaluate the effects of an experimental drug called EMD 128130 on Parkinson's~     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of~     long-term treatment with levodopa. EMD 128130 inhibits the function of serotonin, a chemical~     messenger thought to regulate dopamine release, and thus affect Parkinson's disease symptoms.~      Patients with relatively advanced Parkinson's disease between 30 and 80 years of age may be~     eligible for this 3-phase study.~        -  Phase 1 - Baseline Evaluation~      Participants will have a medical history, physical examination, detailed neurologic~     evaluation, routine blood tests, urinalysis and an electrocardiogram. A chest X-ray and MRI~     or CT scan of the brain will be done if needed. In addition, an ACTH stimulation test will be~     done before and at the end of the study. For this test, a hormone called ACTH is injected~     into a vein. A small amount of blood is drawn before the injection and 30 and 60 minutes~     afterwards to measure levels of another hormone called cortisol. After these tests are~     completed, patients will, if possible, stop taking all antiparkinsonian medications except~     levodopa (Sinemet) for one month before the study begins and throughout its duration.~        -  Phase 2 - Levodopa and Apomorphine Dose Finding~      For 1 to 3 days, patients will be admitted to the NIH Clinical center to undergo a levodopa~     and apomorphine (a dopamine agonist) dose-finding procedure. For this procedure, patients~     will stop taking Sinemet and instead will have levodopa, and subsequently apomorphine,~     infused through a vein. During the infusions, the drug dose will be increased slowly until~     either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the~     maximum study dose is reached. Symptoms will be monitored frequently to find two infusion~     rates: 1) one that is less than what is needed to relieve symptoms, and 2) one that relieves~     symptoms but may produce dyskinesias.~        -  Phase 3 - Active Study~      Patients will begin the treatment phase within 3 months of the dose-finding phase. After a~     brief physical examination, routine blood tests, and evaluation of parkinsonism symptoms,~     patients will begin taking either EMD 128130 tablets or capsules or a placebo (a look-alike~     pill with no active ingredient) twice a day, along with Sinemet, for 3 weeks. All~     participants will receive placebo at least 1 week during the study, and about four patients,~     selected at random, will receive only placebo the entire 3 weeks. Levodopa and apomorphine~     infusions will be repeated at the end of weeks 1, 2 and 3 of Phase 3. The procedure for the~     infusions will be the same as in the dose-finding phase.~      Throughout the study, parkinsonian symptoms and dyskinesias will be assessed and blood~     samples will be drawn periodically to measure drug levels. Patients will return for a~     follow-up evaluation 2 weeks after the end of the study.~   "
273310|NCT00009035|"~     This study offers evaluation of patients with brain and spinal cord tumors. Its purpose is~     threefold: 1) to allow physicians in NIH s Neuro-Oncology Branch to increase their knowledge~     of the course of central nervous system tumors and identify areas that need further research;~     2) to inform participants of new studies at the National Cancer Institute and other centers~     as they are developed; and 3) to provide patients consultation on possible treatment options.~      Children (at least 1 year old) and adults with primary malignant brain and spinal cord tumors~     may be eligible for this study. Participants will have a medical history, physical and~     neurological examinations and routine blood tests. They may also undergo one or more of the~     following procedures:~        -  Magnetic resonance imaging (MRI) MRI is a diagnostic tool that uses a strong magnetic~          field and radio waves instead of X-rays to show detailed changes in brain structure and~          chemistry. For the procedure, the patient lies on a table in a narrow cylinder~          containing a magnetic field. A contrast material called gadolinium may be used (injected~          into a vein) to enhance the images. The procedure takes about an hour, and the patient~          can speak with a staff member via an intercom system at all times.~        -  Computed axial tomography (CAT or CT) CT is a specialized form of X-ray imaging that~          produces 3-dimensional images of the brain in sections. The scanner is a ring device~          that surrounds the patient and contains a moveable X-ray source. The scan takes about 30~          minutes and may be done with or without the use of a contrast dye.~        -  Positron emission tomography (PET) PET is a diagnostic test that is based on differences~          in how cells take up and use glucose (sugar), one of the body s main fuels. The patient~          is given an injection of radioactive glucose. A special camera surrounding the patient~          detects the radiation emitted by the radioactive material and produces images that show~          how much glucose is being used by various tissues. Fast-growing cells, such as tumors,~          take up and use more glucose than normal cells do, and therefore, the scan might~          indicate the overall activity or aggressiveness of the tumor. The procedure takes about~          an hour.~      When all the tests are completed, the physician will discuss the results and potential~     treatment options with the patient. Follow-up will vary according to the individual. Some~     patients may end the study with just one visit to NIH, while others may be followed at NIH~     regularly, in conjunction with their local physicians. Patients with aggressive tumors may be~     seen every 3 or 4 months, while those with less active tumors may be seen every 6 to 12~     months. Permission may be requested for telephone follow-up (with the patient or physician)~     of patients not seen regularly at NIH.~   "
273311|NCT00009178|"~     Bulimia Nervosa is a frequent problem for young women. It is widely assumed that this~     disorder cannot be treated effectively in a primary care setting. This assumption has never~     been tested empirically, and is probably incorrect.~      In the last 15 years, effective treatment interventions for Bulimia Nervosa have been~     developed and validated in specialized treatment centers. The broad aim of this proposal is~     to examine whether these treatments, suitably adapted, can be usefully transferred to general~     health care settings. Specifically, the proposed study will determine the relative and~     combined effectiveness of the two leading treatments for Bulimia Nervosa in a primary care~     setting. The two major interventions are treatment with an antidepressant medication,~     fluoxetine, and with a form of cognitive behavioral therapy, guided self-help, designed for~     use in primary care.~   "
273312|NCT00009009|"~     This study will examine the safety and effectiveness of renal (kidney) transplantation for~     HIV-infected patients with end-stage renal disease (kidney failure). Although kidney~     transplant is the best treatment for most causes of kidney failure, people infected with HIV~     are not offered this procedure because the immunosuppressive drugs (drugs that suppress~     immune function) required to prevent organ rejection could further impair the patient's~     already weakened immune system. This study will use a regimen of immunosuppressants designed~     to complement treatment for patients taking highly active antiretroviral therapy (HAART).~      HIV-infected patients between 18 and 60 years of age with renal failure who have not had any~     opportunistic infections for 5 years may be eligible for this study. Candidates will be~     screened with a medical history, physical examination, and blood and urine tests.~      Before the transplant procedure, participants will undergo additional tests and procedures,~     including blood studies, 24-hour urine collection, infectious disease consultation,~     tuberculin skin test, PAP smear for women, chest X-ray, brain and hip MRI studies and~     DEXA-scan to evaluate bone density. In addition, patients may undergo leukapheresis to obtain~     white blood cells for study. For this procedure, whole blood is drawn through a needle in an~     arm vein and passed through a cell separator machine. The white cells are collected for~     removal, and the rest of the blood is returned to the body through the same needle or another~     needle in the other arm.~      When a donor organ becomes available for transplant, the patient will receive three~     anti-rejection drugs-cyclosporine, mycophenolate mofetil and prednisone-to prevent organ~     rejection. Immediately after the surgery, HAART drugs will be stopped for 7 days until stable~     levels of the immune suppressants can be achieved. Then, HAART will be re-started and all~     medications will be adjusted to achieve adequate blood levels. Patients must stay in the~     local area 60 days after discharge from the hospital for monitoring. Frequent blood samples~     will be taken to monitor kidney function, viral load and CD4+ T cell counts. Follow-up visits~     will then be scheduled monthly for the first 6 months after transplant, then every other~     month for 1 year. Kidney biopsies will be done at the end of the first month, after 6 months,~     and yearly for 5 years. For the biopsy, a special needle is used to remove a small piece of~     kidney tissue for microscopic examination. The biopsies and blood tests are done to evaluate~     the immune response to the transplanted organ and to study how HAART interacts with the~     immune suppressing drugs.~   "
273313|NCT00008892|"~     The purpose of this study is to use brain imaging technology to study the connections between~     brain regions in children with attention deficit hyperactivity disorder (AD/HD), and~     comparing them to children without AD/HD.~      This study will build upon previous brain imaging studies of healthy volunteers and children~     who have AD/HD. This study will use diffusion tensor magnetic resonance imaging (DT-MRI) to~     visualize and measure certain parts of the brains of identical twin pairs in which one twin~     has AD/HD, combined type.~      Participants in this study will be screened with questionnaires and interviews, psychometric~     testing, and a physical examination. Participants' medical and educational records may be~     reviewed. Participants will undergo an MRI scan of the brain. Prior to the MRI, participants~     will have a training session in a simulated MRI scanner to learn how to lie still during MRI~     scanning. Participants may be asked to return for a follow-up scan in about 2 years.~   "
273322|NCT00008541|"~     This study offers evaluation and treatment for patients with certain corneal and external~     diseases of the eye (diseases of the surface of the eye and its surrounding structures). The~     protocol is not designed to test new treatments; rather, patients will receive current~     standard of care treatments. The purpose of the study is twofold: 1) to allow National Eye~     Institute physicians to increase their knowledge of various corneal and external conditions~     and identify possible new avenues of research in this area; and 2) to establish a pool of~     patients who may be eligible for new studies as they are developed. (Participants in this~     protocol will not be required to join a new study; the decision will be voluntary.)~      Children and adults with corneal or external eye diseases may be eligible for this study.~     Candidates will be screened with a medical history, brief physical examination, thorough eye~     examination and blood test. The eye examination includes measurements of eye pressure and~     visual acuity (ability to see the vision chart) and dilation of the pupils to examine the~     lens and retina (back part of the eye). Patients will also undergo the following procedures:~        1. Eye photography - Special photographs of the inside of the eye to help evaluate the~          status of the cornea and conjunctiva (the most superficial layer of the eye) evaluate~          changes that may occur in the future. From two to 20 pictures may be taken, depending on~          the eye condition. The camera flashes a bright light into the eye for each picture.~        2. Conjunctival or lacrimal gland biopsy - A small piece of the conjunctiva or the lacrimal~          (tear) gland, is removed for examination under the microscope. Anesthetic drops and~          possibly an injection of anesthetic are given to numb the eye. An antibiotic ointment~          and patch may be placed over the eye for several hours after the procedure.~      Participants will be followed at least 3 years. Follow-up visits are scheduled according to~     the standard of care for the individual patient's eye problem. Vision will be checked at each~     visit, and some of the tests described above may be repeated to follow the progress of~     disease and evaluate the response to any treatment that is given.~   "
273323|NCT00008515|"~     This study will test the safety and effectiveness of a fluocinolone implant to treat~     age-related macular degeneration. This eye disease can severely impair central vision,~     affecting a person's ability to read, drive, and carry out daily activities. It is the~     leading cause of vision loss in people over age 60. The fluocinolone implant is a tiny~     plastic rod with a pellet of the steroid fluocinolone on the end. The pellet slowly dissolves~     and releases the medication into the fluid in the eye.~      Vision loss in macular degeneration is caused by the formation of new blood vessels in the~     choroid-a thin, pigmented vascular layer of the eye behind the retina. These abnormal vessels~     leak blood under the macula, the part of the retina that determines central vision. Tissue~     studies show evidence of inflammation in the retinas of patients. This study will test~     whether the slow release of the steroid fluocinolone directly into the affected part of the~     eye can prevent or slow further vision loss. Preliminary animal and human studies with~     fluocinolone implants have shown some benefit in reducing blood vessel growth and improving~     or stabilizing vision.~      Patients 50 years of age and older with age-related macular degeneration may be eligible for~     this study. Study patients will be randomly assigned to one of two treatment groups. One will~     receive a 0.5-mg dose implant; the other will receive a 2-mg dose implant. Theoretically, the~     implants can release the medicine for 2 to 3 years.~      Participants will have a medical history, physical examination and complete eye examination.~     The latter will include a vision test, eye pressure measurement, examination of the pupils,~     lens, retina, and eye movements. Photographs of the eye will be taken with a special camera.~     Patients will also undergo fluorescein angiography, a test that takes pictures of the retina~     using a yellow dye called sodium fluorescein. The dye is injected into the blood stream~     through a vein. After it reaches the blood vessels of the eye, photographs are taken of the~     retina.~      When the above tests are completed, patients will be scheduled for surgery to place the~     implant. The procedure will be done under either local or general anesthesia. Follow-up~     visits will be scheduled 1, 2, 4, and 6 weeks after surgery, then at 3 and 6 months after~     surgery, and then every 6 months until the implant is depleted of medicine or is removed.~     Several of the exams described above will be repeated during the follow-up period to evaluate~     the treatment and side effects, if any.~   "
273324|NCT00008502|"~     The purpose of this study is to identify the gene or genes responsible for keloid formation.~     Keloids are raised scars on the skin that form after a minor injury. A tendency to develop~     keloids often runs in families, suggesting a possible genetic basis.~      People who have had a classic (butterfly-shaped or wound-overflowing) keloid for at least one~     year may be eligible for this study. In addition to these probands (original participants),~     family members over 12 years of age who have either classic or non-classic keloids and those~     18 years of age or older without keloids may participate.~      Probands and family members with keloids will have a medical history focusing on skin~     problems particularly keloids and a skin examination. In some cases, with the subject s~     permission, photos of the keloids will be taken. All participants will have 35 milliliters~     (about 2 tablespoons) of blood drawn for DNA (genetic) testing and for measurement of blood~     proteins, including cytokines, which can affect other tissues and cause scarring. Part of the~     blood sample will be used for additional genetic studies unrelated to keloids. The samples~     will be coded for confidentiality.~   "
273325|NCT00008476|"~     This study will test the effectiveness of the drug capsaicin in controlling pain after third~     molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them~     hot, belongs to a class of drugs called vanilloids, which have been found to temporarily~     inactivate pain-sensing nerves.~      Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom~     tooth) extraction may be eligible for this study. Participants will undergo the following~     procedures in three visits:~      Visit 1:~      Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor~     applied to the gums and the patient will rate when they first feel heat and when the heat~     feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums,~     and the patient will say whether it feels painful; 3) a light touch will be applied to the~     gums with a small needle, and the patient will rate the pain intensity following the touch.~      After testing, patients will be numbed with a local anesthetic (bupivacaine) and then~     capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth~     then will be extracted one day later.~      Visit 2:~      Patients will return to the clinic after 24 hours to repeat the same type of sensory testing.~     After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and~     given an intravenous injection of either saline or ketorolac (30 mg). After the extraction,~     pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients~     will be monitored for numbness, pain, side effects and vital signs (heart rate, blood~     pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and~     codeine. Patients will be required to stay for up to 3 more hours after this and then they~     will then be discharged with pain medicine.~      Visit 3:~      Patients will return to the clinic after another 48 hours to repeat the same sensory testing.~     Remaining wisdom teeth will be removed off-study at least three weeks following the first~     visit.~   "
273326|NCT00008450|"~     This pilot clinical trial studies total-body irradiation followed by cyclosporine and~     mycophenolate mofetil in treating patients with severe combined immunodeficiency (SCID)~     undergoing donor bone marrow transplant. Giving total-body irradiation (TBI) before a donor~     bone marrow transplant using stem cells that closely match the patient's stem cells, helps~     stop the growth of abnormal cells. It may also stop the patient's immune system from~     rejecting the donor's stem cells. The donated stem cells may mix with the patient's immune~     cells and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a~     donor can also make an immune response against the body's normal cells. Giving cyclosporine~     and mycophenolate mofetil after the transplant may stop this from happening.~   "
273327|NCT00007800|"~     This clinical trial examines whether the addition of individual sessions of a motivational~     intervention to a state-of-the art behavioral group weight loss intervention for overweight~     women with Type 2 diabetes improves the weight losses and glycemic control outcomes.~   "
273352|NCT00007358|"~     Some newborns are born with congenital heart block (CHB), a condition occurring in babies~     with neonatal lupus. The first part of the study will test the effectiveness of fluorinated~     steroids, including dexamethasone, in improving the heart function and general health of~     newborns who have auto-antibody-associated CHB. The second part of this study will use~     ultrasound and heart monitoring to observe high-risk pregnant women and their fetuses during~     the third trimester of pregnancy.~   "
273328|NCT00007696|"~     Population-based screening for diabetes mellitus in non-pregnant adults remains~     controversial. For a screening strategy to be successful, patients identified by surveillance~     will have to have better outcomes than if they had been diagnosed at a later, more~     symptomatic phase of disease. However, little is known about the fate of patients diagnosed~     with diabetes by screening. Additionally, while about half of the cases of diabetes among the~     general population at any given time are undiagnosed, the prevalence of undiagnosed diabetes~     among veterans is unknown. The annual incidence of diabetes among veterans is also unknown.~      Assessing risk factors prior to blood testing will improve the specificity, with little cost~     in sensitivity, of screening for diabetes in a medical center setting. The target population~     which optimizes the potential value of diabetes screening is patients with at least 1 of the~     above 3 risk factors for diabetes (obesity, hypertension, family history). Hypertension is~     strongly associated with unrecognized diabetes in veterans. VA and other health care~     providers considering whether to perform systematic screening for diabetes should use known~     risk factors to identify an appropriate target population for screening.~   "
273329|NCT00007670|"~     New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These~     patients are especially vulnerable to side effects from medications because of changes caused~     by the aging process and the fact that these patients often have many common diseases for~     which they are already receiving medications for so that the likelihood of drug interactions~     is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the~     FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of~     partial onset seizures, the most common seizures in the elderly. These new compounds also~     have favorable side effect profiles and infrequent drug-drug interactions and, therefore,~     would be expected to be well-tolerated in the elderly.~   "
273330|NCT00007657|"~     PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is~     superior to intensive medical therapy alone using the combined endpoint of all-cause~     mortality or nonfatal MI.~   "
273331|NCT00007774|"~     Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia,~     efficacy and safety profiles need to be improved. Forty to eighty percent of patients either~     fail to respond or only partially respond to conventional antipsychotic agents. Secondary~     symptoms may be unimproved even in patients who respond to treatment. A variety of adverse~     events occur in patients receiving currently available agents. The severity of these events~     contributes to the poor compliance that is observed in this patient population. Olanzapine is~     a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms. Other side~     effects are minimal.~   "
273332|NCT00007761|"~     Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized~     controlled trial of a high-intensity ambulatory treatment program for bipolar disorder~     against standard office-based, physician-centered care. The major characteristics of this~     program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2)~     continuity of care with identified primary mental health nurse clinicians supported by~     psychiatrist back-up, and (3) patient education to improve treatment alliance and illness~     management skills.~   "
273333|NCT00007748|"~     This trial is a study of Gulf War era veterans who have unexplained chronic medical symptoms~     such as pain, fatigue, and/or cognitive difficulties. The treatments to be studied, cognitive~     behavior therapy (CBT) and aerobic exercise, have been shown to be effective in alleviating~     symptoms in individuals with other similar types of illnesses, such as chronic fatigue~     syndrome and fibromyalgia. This is a Phase 3, 2X2 factorial designed study. All study~     participants are assigned to one of four treatment groups - CBT and aerobic exercise, aerobic~     exercise alone, CBT alone or usual and customary care. This study durations is 28 months;~     1092 participants were enrolled and will be followed in clinic at 3, 6 and 12 months after~     enrollment.~   "
273334|NCT00007735|"~     In 1990 and 1991, the U.S. deployed approximately 700,000 troops to the Persian Gulf to~     liberate Kuwait from Iraqi occupation. While there were few casualties associated with the~     Gulf War, many individuals returned from this conflict with unexplained symptoms and~     illnesses. This constellation of symptoms has been termed Gulf War Veterans' Illnesses (GWI).~     Although several explanations have been offered as to the cause of GWI, none of the putative~     etiologic agents or conditions is currently supported by sufficient evidence. One explanation~     that has received fairly widespread attention is systemic Mycoplasma fermentans infection. It~     is the purpose of this study to determine if antibiotic treatment directed against Mycoplasma~     species (i.e. doxycycline) will improve functioning and symptoms in deployed Gulf War~     veterans with GWI.~   "
273335|NCT00007722|"~     Recently, concern has arisen regarding a possible elevated occurrence of ALS among veterans~     who served in the Persian Gulf during Operations Desert Shield (August 2, 1990 - January 15,~     1991), Desert Storm (January 16, 1991 - February 28, 1991) and Clean-up (March 1, 1991 - July~     31, 1991). This study involves an epidemiologic investigation into the occurrence of ALS~     among veterans of the Gulf War. This study will further define the epidemiology of this~     neurological disease among younger individuals while determining whether there is a higher~     than expected occurrence. It will also ascertain the etiologic importance of deployment to~     the Persian Gulf and exposure to specific environmental factors in that geographic area. VA~     is leading this joint federal government epidemiologic study that also involves DoD, HHS,~     CDC, and academic centers of excellence in neurology, with advice from the ALS Association.~   "
273378|NCT00006526|"~     To investigate use of Fast Gated Helical Computed Tomography (FGHCT) measures of coronary~     artery calcium (CAC), FGHCT-CAC, for discrimination of coronary artery disease (CAD) and to~     quantify progression of coronary artery calcium over time.~   "
273552|NCT00006135|"~     OBJECTIVES:~      I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants~     with herpes simplex virus infection limited to skin, eyes, and mouth.~      II. Determine the neurologic outcome in these patients when treated with this regimen.~      III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain~     reaction (PCR) result when all other CSF parameters remain normal in these patients.~      IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with~     clinical neurological assessment in these patients when treated with this regimen.~      V. Determine whether the continuous administration of this drug suppresses recurrent skin~     lesions in these patients.~      VI. Determine the safety of this regimen in these patients.~   "
273336|NCT00007709|"~     It is suspected, but not well documented, that persons with severe mental illness (SMI)~     represent a significant transmission source of serious infectious diseases. SMI diagnoses are~     defined as schizophrenia, schizoaffective disorder, bipolar disorder, or posttraumatic stress~     disorder (PTSD). Severely mentally ill persons are at high risk for Human Immunodeficiency~     Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS). To assess the risk of HIV and related~     infections among these individuals, the National Institute of Mental Health (NIMH) Office on~     AIDS funded the HIV/SMI five site collaborative study Assessing HIV/AIDS and Associated~     Health Risks in People with Severe Mental Illness. This Durham ERIC study supplements the~     NIMH HIV/SMI study with a four-year longitudinal cohort study of 300-plus SMI veterans in~     order to estimate the prevalence of HIV risk behaviors and HIV infection, as well as to~     measure utilization of health services over time. The Durham VA is the only VA site~     represented in the study and is collaborating with four non-VA sites including Dartmouth,~     University of New Hampshire, University of Connecticut and Duke University. As such, we have~     the additional goals of investigating health and health-care-service issues relevant to~     veterans with SMI and of establishing a database for the longitudinal study of veterans with~     SMI.~   "
273337|NCT00007683|"~     Whether patients with chronic heart failure (CHF) should be anticoagulated is one of the~     oldest unresolved questions in cardiovascular therapeutics. Some authorities do not recommend~     anticoagulation for CHF patients in sinus rhythm, others recommend anticoagulation in~     patients with primary cardiomyopathy, and still others consider it more appropriate in~     patients with coronary artery disease (CAD). This absence of consensus reflects the lack of~     evidence in this area and different outlooks on the objectives of such therapy (e.g.,~     prevention of arterial emboli or reduction in vascular events).~   "
273338|NCT00007644|"~     Radical prostatectomy provides potentially curative removal of the cancer. However, it~     subjects patients to the morbidity and mortality of the surgery and may be neither necessary~     nor effective. Expectant management does not offer potential cure. However, it provides~     palliative therapy for symptomatic or metastatic disease progression, avoids potentially~     excessive and morbid interventions in asymptomatic patients, and emphasizes management~     approaches for focus on relieving symptoms while minimizing therapeutic complications.~      The primary objective of this study is to determine which of two strategies is superior for~     the management of clinically localized CAP: 1) radical prostatectomy with early aggressive~     intervention for disease persistence or recurrence, 2) expectant management with reservation~     of therapy for palliative treatment of symptomatic or metastatic disease progression.~     Outcomes include total mortality, CAP mortality, disease free and progression free survival,~     morbidity, quality of life, and cost effectiveness.~   "
273339|NCT00007631|"~     One-third of all malignancies in the United States (approximately one million cases diagnosed~     annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic~     burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies~     with a topical agent free of serious side effects would confer substantial public health~     benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is~     one of the most common conditions requiring dermatologic care in the VA system. Topical~     tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in~     high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have~     unacceptable toxicity. In this study, 1131 patients with a recent history of squamous cell~     and/or basal cell carcinoma were enrolled at six participating centers over a four-year~     period and were randomly assigned to either 0.1% tretinoin cream or placebo. They were~     followed for a minimum of two years to determine if topical tretinoin is effective in~     reducing the risk of new occurrences.~   "
273340|NCT00007618|"~     Colorectal cancer is the second leading cause of cancer death in the United States each year.~     Approximately one million veterans aged 50 and older will develop colorectal cancer over the~     remainder of their lives and nearly 433,000 will die from it. Because most cancers are~     diagnosed after local or regional spread, nearly half of all patients diagnosed with~     colorectal cancer will die. On a national basis, the relative five year survival with~     colorectal cancer was estimated at approximately 40% among veterans, substantially lower than~     SEER estimates in the general population of 61.7% (colon) and 59.3% (rectum). Colorectal~     cancer is preventable through screening, however and, if diagnosed in an early stage (Dukes'~     A and B), is curable.~      This is the first study to examine factors that might explain the worsened prognosis for~     veterans with colorectal cancer. If modifiable factors such as physician and patient delay in~     diagnosis, or poverty, explain the increased mortality among veterans, educational programs~     and interventions that improve the process of care associated with screening and diagnosis~     can be instituted.~   "
273341|NCT00007605|"~     Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million~     cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of~     the latter occurring annually in patients with atrial fibrillation. The safety of the most~     widely used antiarrhythmic agent for this group of patients, quinidine, has been called into~     question. This study seeks to determine whether two other agents, amiodarone and sotalol, are~     safe and effective treatments for patients with atrial fibrillation.~   "
273342|NCT00007592|"~     Hypertension is one of the most common medical problems in the United States and in the VA~     health care system. It has been well-documented that hypertension can be effectively treated.~     However, there remain important unresolved clinical questions in the area of antihypertensive~     treatment. For example, how much is mortality affected by visit compliance, blood pressure~     control and type of antihypertensive agent? Or, are some regimens associated with more~     morbidity than others? Or, are there inexpensive regimens that are as effective as more~     expensive regimens? The amount of data that is available from this demonstration project~     (currently 6,100 patients) will help address these questions. The answers to these questions~     should result in better care for veterans with hypertension.~   "
273397|NCT00006498|"~     To prospectively examine the association between a specific chronic life stressor (i.e.,~     intimate violence exposure) and adult asthma in women.~   "
273398|NCT00006497|"~     To assess changes in coronary calcium measured by electron beam computed tomography (EBCT) as~     a predictor of coronary heart disease (CHD) events.~   "
273399|NCT00006496|"~     To examine the possible relationship between genetic factors and the acute respiratory~     distress syndrome (ARDS).~   "
273343|NCT00007579|"~     Primary Objectives: To explore racial differences in potential risk factors for developing~     prostate cancer in the VA population and to compare and contrast the results of this study~     with that of an ongoing NCI-funded study in North Carolina.~      Secondary Objectives: To investigate familial aggregation of prostate cancer in blacks and~     whites. To determine whether screening behavior differs in men diagnosed with early stage~     prostate cancer versus those with later stage disease as well as to determine if screening~     behavior differences exist between blacks and whites.~      Primary Outcomes: The primary outcomes are pesticide, occupational and chemical exposure, and~     dietary history. Other major endpoints include: 1) familial aggregation of prostate cancer;~     2) weight, weight history, and weight cycling; 3) subject's knowledge, attitudes, and~     behaviors about prostate cancer; and 4) treatment choices.~      Intervention: N/A~      Study Abstract: Prostate cancer is the most commonly diagnosed cancer in American men. Among~     African Americans the incidence and mortality from prostate cancer is even greater. Although~     incidence rates in the Southern United States tend to be only slightly higher than that of~     the nation, a clear discrepancy exists between national mortality rates and those in the~     Southeastern United States. Notably high rates, particularly among African Americans are~     observed and in North Carolina the prostate cancer mortality rate among African Americans is~     the highest of any state in the nation. In spite of these statistics, very little is known~     about racially based differences in the etiology of this disease.~      This study hypothesizes that racial differences in the incidence and mortality of prostate~     cancer may be a result of multiple factors including those that are socioeconomic,~     environmental, dietary and genetic. This research will provide insight into~     gene-environmental interactions that initiate and promote prostatic neoplasia as well as~     address whether there are differences in patterns of care which impact morbidity and~     survival. The results of this study will also be compared to findings in non-veterans that~     are being generated through an NCI-funded sister study of these issues under the direction of~     co-investigator, Dr. JoEllen Schildkraut of Duke University.~      Subjects were identified from pathology reports extracted from VISTA. Additionally, subjects~     were identified by reviewing radiation/oncology clinic records for those subjects referred~     for radiation treatment. Subject enrollment concluded with 100 cases and 98 controls enrolled~     in the study~   "
273344|NCT00007540|"~     Prostate cancer is diagnosed in approximately 334,500 men each year and accounts for nearly~     41,800 deaths in the United States. Prostate cancer is the leading cancer affecting veterans~     and the second leading cancer among all Americans. The causes of prostate cancer and,~     particularly, the reasons for the unusually high incidence rates in African-Americans remain~     obscure. Dietary factors likely play a role in fatal cases, while hormones are also important~     in regulating prostate cancer growth. Dr. Charles Huggins recognized this effect in the~     1940?s, with androgen deprivation remaining as the cornerstone of therapy for advanced~     disease. Despite the strong circumstantial evidence, neither epidemiologic studies nor basic~     sciences have produced clear insight into the etiologic role of hormones. However, recent~     observations regarding androgen receptor gene polymorphisms and their relation to endocrine~     expression and prostate cancer risk may be providing important clues as to how an etiologic~     role might be mediated at the molecular level. Thus, it is important to attempt to identify~     genetic markers of high-risk cancer patients for necessary screening and counseling efforts.~   "
273345|NCT00007527|"~     The CS 1018 study will recruit a total of 600 patients seeking treatment for opiate~     dependence. They will be recruited from six states (Florida, New York, Texas, California,~     Washington, and Illinois), with up to ten private physician sites or clinics participating in~     each state. Coordination of the participating sites and clinics in each of the six states~     will be performed from an associated Department of Veterans Affairs Medical Center (Tampa~     VAMC, New York City VAMC, San Antonio VAMC, Long Beach VAMC, Seattle VAMC, and Hines VAMC).~     The Principal Investigator (PI) at each of the six VAMC?s will be a physician experienced in~     the treatment of opiate dependent patients.~      Patients will be recruited by any of numerous strategies including word of mouth,~     self-referral, local fliers, newspapers, and radio advertisements. This study will be~     conducted open label with no random assignment or stratification. Patients may be accepted~     for detoxification or longer-term treatment (6 to 12 months of buprenorphine/naloxone~     therapy). Patients under the age of 21 will initially be admitted for detoxification; longer~     treatment of these patients will be based on physician judgement of the necessary of~     continued treatment. Patients will be inducted directly into buprenorphine/naloxone 4:1~     combination tablets. Patients treated in private practice will be asked to sign a treatment~     contract which will delineate the terms and conditions of treatment.~   "
273346|NCT00007514|"~     Significant subsets of military veterans have reported such health problems as headache,~     joint pain, fatigue, and memory/concentration difficulties subsequent to their participation~     in the Gulf War. However, the etiology remains controversial. A number of toxins have been~     implicated as etiologic factors for GW-related health problems; however, exposure levels have~     been difficult, if not impossible, to document retrospectively. These difficulties with~     exposure verification have led GW researchers to de-emphasize methods typical of~     neurotoxicological research examining exposure-symptom relationships and instead focus on~     epidemiological approaches emphasizing identification of coherent symptom patterns.~   "
273347|NCT00007501|"~     The incidence and severity of HZ (or shingles), as well as the frequency and severity of its~     complications, increases markedly with increasing age. More than half of all cases occur in~     persons over the age of 60. Even without complications, HZ can interfere with an elderly~     patient's ability to perform essential activities of daily living, resulting in a loss of~     independence that is emotionally devastating and frequently irreversible. The most common~     complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently~     results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral~     therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent~     the development of PHN.~      This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to~     determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the~     incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of~     age and older.~   "
273348|NCT00007475|"~     Focal segmental glomerulosclerosis (FSGS) is a renal syndrome characterized by proteinuria~     (usually nephrotic range), limited response to conventional therapy, and a poor renal~     prognosis, with progression to end stage renal failure in at least 50% of patients. As a~     syndrome, FSGS likely has many specific etiologies, only a few of which are well-defined.~     Recently, it has been suggested that some idiopathic FSGS patients have elevated circulating~     levels of a protein that induces glomerular permeability in vitro and in vivo. While there~     has been no consistent term for this factor, it will be termed here FSGS permeability factor~     (FPF).~      The purposes of the present study are five fold:~        1. To identify a population of FSGS patients with elevated FPF levels~        2. To examine RNA expression profiles of peripheral blood mononuclear cells (PBMC) in FSGS~          patients with elevated FPF levels~        3. To define the kinetics of FPF disappearance and reappearance in FSGS patients receiving~          immunomodulatory therapy and in the case of patients with recurrent FSGS following renal~          transplant, those receiving plasma exchange~        4. To identify immunosuppressive agents which are successful in inducing sustained~          reduction in FPF levels~        5. To determine in patients with FSGS who are awaiting renal transplant, whether sustained~          reduction in FPF levels is associated with reduced risk of recurrent FSGS.~      Patient participation is divided into an evaluation phase, in which FPF levels, RNA~     expression profiles, and patient eligibility for participation in treatment protocols are~     determined, and a treatment phase in which specific immunomodulatory therapy is introduced in~     an open label fashion. We propose to define carefully the relationship between elevated FPF~     and remission of proteinuria in patients with FSGS in native kidneys, following treatment~     with standard therapies (daily prednisone, cyclophosphamide) and experimental therapies~     (pulse dexamethasone, pirfenidone). In patients with recurrent FSGS in renal allografts, we~     will determine the kinetics of FPF following plasma exchange and following plasma exchange~     plus cyclophosphamide. In patients with elevated FPF levels who are awaiting renal~     transplantation, we will determine the kinetics of FPF following plasma exchange and~     following plasma exchange plus cyclophosphamide, and examine the rate of recurrent FSGS in~     these patients.~   "
273353|NCT00007345|"~     Background:~      NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent~     cytotoxic activity against human tumor cell lines and in vivo efficacy against both human~     tumor xenografts and murine tumors (1-3).~      NSC 630176, herein referred to as depsipeptide, shows a lack of cross resistance with several~     commonly used cytotoxic agents such as vincristine, 5-fluorouracil, mitomycin C and~     cyclophosphamide (2). However, it has been defined as a P-glycoprotein (Pgp) substrate by~     COMPARE analysis of the National Cancer Institute (NCI) drug screen cytotoxicity profile (4).~      Depsipeptide is a member of a novel class of antineoplastic agents, the histone deacetylase~     inhibitors.~      In the phase I trial conducted at the National Cancer Institute (NCI), responses were~     observed at the maximum tolerated dose (MTD) in patients with cutaneous and peripheral T-cell~     lymphoma.~      Objectives:~      In patients with cutaneous T-cell lymphoma, the primary end points to be examined are overall~     response rate, complete response rate and duration of response.~      In patients with relapsed peripheral T-cell lymphoma, the endpoints to be examined are~     overall response rate and complete response rate.~      To evaluate the tolerability of depsipeptide with extended cycles of therapy.~      Eligibility:~      Patients with cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) or other~     peripheral T-cell lymphomas are eligible.~      Design:~      Depsipeptide will be administered at 14 mg/m^2, over 4 hours on days 1, 8 and 15.~      This trial will accrue in six cohorts; Arm 1, patients with cutaneous T-cell lymphoma who~     have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 2, patients~     with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic~     chemotherapy regimens; Arm 3, patients with cutaneous and peripheral T-cell lymphoma who have~     had more than two prior cytotoxic chemotherapy regimens; Arm 4, patients with other mature~     T-cell lymphomas; Arm 5, a replicate arm of arm 1; Arm 6, patients with peripheral T-cell~     lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 7, patients~     with cutaneous T cell lymphoma who have received vorinostat.~      Dose may be adjusted based on toxicities.~   "
273354|NCT00007306|"~     This is a clinical study in two phases. The first phase compares the effect of an ointment~     containing parathyroid hormone (PTH) with the effect of a placebo ointment (inactive ointment~     without PTH) on psoriasis lesions. Neither the study participants nor the researchers will~     know who is receiving PTH ointment and who is receiving placebo until the end of this first~     study phase. The second phase is a study of the PTH ointment on large areas of psoriasis to~     find out how long the effects last.~   "
273355|NCT00007293|"~     This study will test the safety and effectiveness of a novel fiber optic device for treating~     scalp psoriasis with ultraviolet (UV-B) light. A effective treatment is not currently~     available for people with scalp psoriasis. Present methods for treating psoriasis with UV-B~     light cannot be used for the scalp because hair is usually blocking the light from reaching~     the affected skin. Our method overcomes this problem with the use of a comb that has optical~     fibers to deliver light directly to the skin. We will evaluate this device in a clinical~     setting and will use the results to tailor the design of the comb before producing it in~     large quantities.~   "
273356|NCT00007280|"~     This study will look at whether a graft of bioengineered skin (BSC), known commercially as~     Apligraf, stimulates the healing process in a person's own skin at the edge of a wound (known~     as the edge effect). The information from this study will provide a better understanding of~     the ways that grafts of bioengineered skin help the healing of chronic wounds.~      We will assign study participants to either the bioengineered skin group or the control~     group. People in the control group will receive compression therapy with a multilayered~     compression bandage. We will examine each participant before starting treatment and then once~     a week for 24 weeks or until the wound heals. On the first day of treatment (day 0) and at~     week 3, week 6, and week 24 (end of treatment) we will take a small tissue sample from the~     wound for a biopsy. After the wound is completely healed, we will ask the patient to return~     once a month for 6 months to make sure the wound stays healed.~   "
273357|NCT00007267|"~     This study will examine the effectiveness of two psychological treatment approaches designed~     to help people who have scleroderma with three important areas of daily living: pain,~     depression, and distress about changes in appearance. The study will also evaluate the impact~     of depression on the two psychological treatments. Because psychological approaches requiring~     a trained professional can be expensive and are often not available to most patients, this~     study will also look at the effectiveness of a self-help treatment approach.~   "
273358|NCT00007254|"~     This study tests the effectiveness of a morphine-containing gel for reducing pain caused by~     pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing~     morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.~   "
273359|NCT00007241|"~     Studies have shown that isometric strengthening helps people with osteoarthritis of the knee.~     Isometric strengthening is muscle-strengthening exercise without movement, in which a person~     applies a force against a resistant object--for example, pushing against a brick wall. This~     study will test the effectiveness of a portable isometric exercise device for home use that~     guides a person through an exercise program using various forms of feedback. We will look at~     whether people exercising with the device achieve better outcomes (results) in pain,~     stiffness, strength, and functional measures compared to people who do not use the device or~     people exercising according to printed material from arthritis organizations.~   "
273360|NCT00007228|"~     The purpose of this study is to learn about heart and skeletal muscle problems related to~     neuroacanthocytosis (also called Mcleod's syndrome and Levine-Critchley disease). This~     inherited condition causes problems of blood, brain, heart and muscle function. About 60~     percent of patients have an unusual heart muscle abnormality that increases the risk of~     sudden death. Although the molecular (genetic) changes responsible for neuroacanthocytosis~     have recently been identified, the heart and skeletal muscle problems are not well~     understood. This study will try to correlate the specific genetic abnormalities with the~     clinical features of the disease and identify possible causes of sudden death.~      Patients and first degree relatives of patients with neuroacanthocytosis 18 years of age or~     older may be eligible for this study. Participants will be admitted to the National~     Institutes of Health Clinical Center for 2 to 5 days for the following tests:~        -  Electrocardiogram - to measure the electrical function of the heart~        -  Echocardiogram - uses ultrasound to measure heart thickness and detect heart vessel~          obstructions~        -  Cardiac magnetic resonance imaging (MRI) - uses a magnetic field and radio waves to~          provide pictures of the heart for measurements of muscle thickness and muscle function~        -  Exercise testing on a stationary bicycle - to measure and record symptoms during~          exercise, exercise duration, heart rate and blood pressure, oxygen consumption and~          aerobic threshold~        -  Holter monitoring - uses a device attached to the chest for continuous recording of~          heart rhythms~        -  Blood tests - to look for muscle damage, to exclude other causes of muscle disease, and~          to perform DNA (genetic) testing~        -  Neurological consultation - to test muscle function, coordination and tests of certain~          brain functions such as memory and concentration~      Patients with evidence of muscle disease may also undergo a muscle biopsy. This is done under~     a local anesthetic and possibly small amounts of sedation. A small area of skin over a large~     arm muscle (biceps) is numbed, a short incision is made and a small sample of muscle tissue~     is removed for microscopic examination.~      Patients with evidence of heart disease may also undergo the following additional tests:~        -  Cardiac catheterization and electrophysiological study - to determine the extent of~          heart disease and study abnormal heart rhythms. Cardiac catheterization is done under~          mild sedation. The groin is numbed with an anesthetic and catheters (thin plastic tubes)~          are inserted and passed through the blood vessels into the chambers of the heart.~          Pressures inside the heart are measured and pictures may be taken of the heart arteries.~          During this procedure an electrophysiology test may be done to study abnormal heart~          rhythms.~        -  Cardiac biopsy - to examine heart muscle tissue. This may be done at the end of the~          cardiac catheterization. Small samples of heart muscle are obtained using a fine~          instrument passed through the catheter in the groin.~      Family members who do not have signs of heart or muscle disease will only undergo~     non-invasive tests. All participants will be given the results of all tests and treatment~     options will be discussed.~   "
273361|NCT00007215|"~     This study will use a newly developed instrument called dynamic light scattering device (DLS)~     to examine age-related changes in the human lens and to study the causes and development of~     cataracts. DLS uses a low intensity laser light (similar to that used in supermarket~     checkouts) to measures lens cloudiness. It detects changes in the human lens at the earliest~     stages, when anti-cataract treatment would be most effective in reversing, delaying or~     preventing cataract formation.~      Patients 18 years of age and older with cataracts and normal volunteers between the ages of~     18 and 70 years may be eligible for this study. Participants will have a standard eye~     examination, including a vision check, pressure measurement, lens examination using DLS and~     examination of the retina. Photographs of the lens or retina, or both, may be taken.~      This study does not involve treatment. No anti-cataract medications will be given.~   "
273362|NCT00007189|"~     The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory~     medications naproxen and celecoxib to delay or prevent the onset of AD and age-related~     cognitive decline.~   "
273456|NCT00006331|"~     Research participants will be asked to undergo complete medical history, physical examination~     and blood tests. The purpose of these tests is to determine whether persons are predisposed~     to develop diabetes mellitus after kidney transplantation and also to make an early diagnosis~     if a patient develops diabetes mellitus. Medical information collected as part of the~     standard transplant evaluation and posttransplant medical care may be incorporated into this~     study. It is important to realize that research subjects will not be given an experimental~     drug as part of this study.~      After kidney transplantation, research subjects will be followed in the posttransplant clinic~     visits. The study will last up to 6 months. During this time the subjects may be asked to~     participate in clinical assessment visits (medical history and physical examination), and~     also during the third or fourth month after transplant will be asked to do a repeat glucose~     tolerance test.~   "
273363|NCT00007163|"~     This study will examine the safety and effectiveness of an experimental drug called J695 for~     treating patients with Crohn's disease-a long-term recurring inflammation of the small and~     large intestine. This disease is currently treated with steroids, sulfasalazine (Azulfidine),~     5-ASA drugs (Pentasa, Asacol), immune suppressants, antibiotics, and an antibody against~     TNF-alpha. Despite the number and variety of available therapies for Crohn's disease, many~     patients do not respond adequately to treatment or they develop severe side effects from the~     medicines. Therefore, new treatments must be developed. J695 is an antibody that is identical~     to a human antibody but chemically changed so that it can attach to and eliminate an~     inflammatory chemical made by the body called interleukin-12 (IL-12). Animal studies have~     shown that eliminating IL-12 with an antibody can prevent inflammation in the gut and can~     also heal inflammation that has already developed.~      Patients 18 years of age and older who have had Crohn's disease for at least 4 months may be~     eligible for this study. Candidates will be screened with a medical history and physical~     examination, electrocardiogram, chest X-ray, blood and urine tests, stool analysis and~     possibly a review of medical records. They will complete a Crohn's Disease Activity Index~     Questionnaire for 7 days. Participants will be randomly assigned to one of two treatment~     groups, as follows:~      Group 1~      Patients in this group will receive an injection of either J695 or placebo (a solution that~     does not contain any active medicine) under the skin on day 1 of the study, on day 29, and~     then weekly for a total of seven injections. After the last injection, patients will be~     followed for an additional 18 weeks. They will be monitored periodically throughout the study~     with physical examinations, disease activity index scores, and blood and urine tests.~      Group 2~      Patients in group 2 will receive an injection of J695 or placebo on day 1 of the study and~     then weekly for a total of six injections. They will be followed for an additional 18 weeks.~     Patients will be monitored as described above for group 1.~      Participants may be asked to undergo additional tests as part of a sub-study in this~     protocol. These include colonoscopies to examine changes in inflammation in the gut and blood~     tests to analyze changes in the cells and body chemicals that affect the inflammation.~   "
273364|NCT00007150|"~     This study will evaluate the effectiveness of a test called MCV in guiding phlebotomy (blood~     drawing) therapy in patients with hemochromatosis an inherited disorder that causes too much~     iron to be absorbed by the intestine. The excess damages body tissues, most severely in the~     liver, heart, pancreas and joints. Because iron is carried in the hemoglobin of red blood~     cells, removing blood can effectively lower the body s iron stores.~      Patients with hemochromatosis undergo weekly phlebotomy treatments (1 pint per session) to~     deplete iron stores. This usually requires 10 to 50 treatments, after which blood is drawn~     every 8 to 12 weeks to prevent a re-build up of iron. A test that measures ferritin a protein~     involved in storing iron is commonly used to guide phlebotomy therapy in hemochromatosis~     patients. This study will compare the usefulness of the ferritin test with that of MCV, which~     measures red blood cell size, in guiding phlebotomy therapy. In addition, the study will 1)~     examine whether keeping iron levels low during maintenance therapy can help heal severe liver~     disease and improve arthritis in affected patients, and 2) design a system for making blood~     collected from hemochromatosis donors available for transfusion into other patients.~      Patients 15 years and older with diagnosed hemochromatosis or very high iron levels~     suggesting possible hemochromatosis may be eligible for this study. Candidates will have a~     history, physical evaluation, review of medical records and blood tests, and complete a~     symptoms questionnaire. Participants will have the following procedures:~        -  Phlebotomy therapy every 1 to 2 weeks, depending on iron levels~        -  Blood sample collection for blood cell counts and iron studies at every phlebotomy~          session~        -  Blood sample collection (about 2 tablespoons) every 1 to 2 weeks after iron stores have~          been depleted~        -  Phlebotomy every 8 to 12 weeks after iron stores are used up to prevent re-build up of~          excess iron~      With each blood donation that will be made available for transfusion to other patients,~     participants will answer the same health history screening questions and undergo the same~     blood tests given to all regular volunteer blood donors. These include screening for the HIV~     and hepatitis viruses and for syphilis.~      Patients who meet height and weight requirements may be asked to consider double red cell~     donations using apheresis. In this procedure, whole blood is collected through a needle~     placed in an arm vein, similar to routine phlebotomy. The blood then circulates through a~     machine that separates it into its components. The red cells are removed and the rest of the~     blood is returned to the body, either through the same needle or through a second needle in~     the other arm. Patients who have very high iron levels or an enlarged liver will be offered~     evaluation by the NIH Liver Service. Those judged to be at increased risk for cirrhosis may~     be advised to undergo a liver biopsy. If cirrhosis is found, the patient will be asked to~     consider a repeat biopsy after 3 to 5 years of continuous iron depletion to see if scarring~     has improved. Patients with arthritis will be offered evaluation by the NIH Arthritis Service~     and, depending on symptoms, may be advised to have X-ray studies or a joint biopsy.~   "
273365|NCT00007137|"~     This study will use magnetic resonance imaging (MRI) and ultrasound to examine changes in~     tongue volume and blood circulation during tongue exercises that require the use of different~     tongue muscle movements and contractions. More information on the structure and function of~     the human tongue is needed to develop better treatments for people with certain diseases~     affecting speech and swallowing.~      Normal volunteers between 21 and 80 years old who live in the metropolitan Washington, D.C.,~     area may be eligible for this study. Candidates will be screened with a brief medical history~     and physical examination, including suitability for MRI testing, and a brief examination of~     tongue, lip and jaw movements.~      Participants will undergo ultrasound and MRI studies. During both tests, they will perform~     tongue exercises, such as holding a soft round object on the tongue or exerting tongue~     pressure against the back of the throat or roof of the mouth.~      During the ultrasound, the subject lies on a flattened dental chair. A small transducer is~     placed under the chin to take images of the tongue during the exercises. A thin rubber strip~     with air-filled pressure bulbs is attached to the roof of the mouth (with dental adhesive) to~     measure tongue pressure.~      For the MRI, the subject lies on a table that slides inside a donut's machine containing a~     magnetic field. MRI coils-special padded sensors that improve image quality-are placed around~     the head and neck. A pressure cuff placed around the arm measures blood pressure. The subject~     wears earplugs to muffle loud thumping noises that occur during electrical switching of the~     magnetic fields. The subject is in constant visual contact with the researchers and MR~     technologist and may request to stop the study at any time.~      Participants may undergo another procedure, called magnetic resonance diffusion tensor~     imaging, to examine how the fluid (water) in the tongue tissue shifts during tongue~     maneuvers. This procedure is essentially the same as the first MRI study, but two small round~     coils are placed in the mouth (one on each side) between the cheeks and the teeth.~   "
273366|NCT00007124|"~     This study will examine the effect of a restricted-carbohydrate diet (ketogenic diet) on~     Lafora disease-a severe neurological disease in which brain cells die because of abnormal~     accumulation of glucose (a type of sugar). Patients with Lafora disease have rapid~     neurological deterioration with myoclonus (brief muscle jerks), seizures and mental decline.~     At present there is no treatment to halt disease progression.~      Patients 10 years of age and older with relatively advanced Lafora disease may be eligible~     for this study. Participants will be admitted to the Clinical Center for the first 4 weeks of~     this 6-month study for baseline testing and to start the ketogenic diet. They will have a~     complete medical history and physical examination, plus a detailed neurological examination~     and blood and urine tests. Procedures include:~        -  Magnetic resonance imaging (MRI) brain scans to provide information about brain~          chemistry~        -  Lumbar puncture (spinal tap) to analyze chemicals in cerebrospinal fluid~        -  Metabolic and endocrinological tests, including a glucose tolerance test, to evaluate~          the body's response to a large intake of oral glucose~        -  Standard neuropsychological tests~        -  Magnetic resonance spectroscopy of the brain and muscle~        -  Electroencephalography (EEG) to measure brain wave activity~        -  Electromyography (EMG) to measure muscle activity~        -  Evoked potentials (SEP and VEP) to study brain responses to mild electric or visual~          stimulation.~      Transcranial magnetic stimulation (magnetic stimulation of the brain) may also be done to~     study the function of the brain cortex (outer nervous tissue of the brain) and the effects of~     treatment on brain excitability.~      The ketogenic diet will begin after the tests are completed. The diet provides mainly fats to~     fuel the body, plus the recommended amount of protein and minimum carbohydrate. Vitamin and~     mineral supplements are provided to meet daily requirements. After 2 weeks on the diet, the~     patient will be discharged from the hospital and seen daily as an outpatient for another 1 to~     2 weeks. During this time the patient or caregiver is trained in preparing the ketogenic~     diet, and then the patient is discharged to home. Throughout the study, disease symptoms will~     be assessed using standardized rating scales. Blood and urine tests will be done as needed,~     as will follow-up brain imaging, neuropsychological and neurophysiological evaluations.~      A skin and/or muscle biopsy may be done at the first clinic visit to grow skin cells in~     culture and to analyze the skin and muscle under a microscope. The biopsy area is numbed with~     an anesthetic and a small piece of tissue is removed either with a needle, an instrument~     similar to a cookie-cutter or a knife. The skin cells may be used for metabolic studies and~     to obtain DNA for genetic testing.~      At the end of the study, patients who responded well to the treatment with no significant~     adverse side effects may continue the diet for another 12 months. They will be followed at~     3-month intervals to monitor side effects and treatment response.~   "
273367|NCT00007111|"~     To track blood pressure from childhood through adolescence.~   "
273368|NCT00007098|"~     To define the relation of insulin resistance during childhood and adolescence to the~     development of the insulin resistance syndrome in young adulthood.~   "
273369|NCT00007085|"~     To determine the value of contrast enhanced spiral computed tomography (spiral CT) for the~     diagnosis of acute pulmonary embolism (PE).~   "
273370|NCT00007059|"~     OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization~     on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic~     liver transplantation.~      II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate~     dehydrogenase activity in these patients.~   "
273371|NCT00007046|"~     OBJECTIVES: I. Identify and characterize the gene causing diaphyseal medullary stenosis with~     malignant fibrous histiocytoma of the bone.~      II. Determine the clinical manifestations of this disease in these patients.~   "
273372|NCT00007033|"~     OBJECTIVES:~      I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin~     D and reduced bone density in children with chronic cholestatic liver disease.~   "
273373|NCT00007020|"~     OBJECTIVES:~      I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate~     treatment to patients with identified inborn errors of bile acid synthesis and metabolism~      II. To assess the safety and tolerability of cholic acid~   "
273374|NCT00006565|"~     The purpose of this study is to test the effects of reducing indoor environmental tobacco~     smoke (ETS) on unscheduled asthma visits, asthma symptoms, airway inflammation, and exposure~     to tobacco smoke measured using air nicotine dosimeters, serum and hair cotinine.~   "
273375|NCT00007371|"~     To define the natural history, immunologic, and genetic factors that influence the clinical~     outcome of hepatitis C in a cohort of hemophilic siblings.~   "
273376|NCT00006552|"~     To assess factors that may influence adherence to antihypertensive drug therapy.~   "
273377|NCT00006539|"~     To evaluate a series of thrombotic, inflammatory, and genetic markers for myocardial~     infarction among participants in the Women's Health Initiative Observational Study (WHI-OS).~   "
273379|NCT00006519|"~     This study will test the safety, side effects and anti-HIV activity of different doses of~     capravirine in children and adolescents with HIV infection. Capravirine belongs to a class of~     drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which prevent the~     virus from replicating (making more copies of itself). Other NNRTIs are nevirapine,~     delavirdine and efavirenz.~      HIV-infected children between the ages of 4 months and 21 years may be eligible for this~     study if they: 1) have received less than 6 weeks of treatment with antiretroviral drugs; 2)~     have not benefited from antiretroviral therapy after 12 weeks of treatment; 3) cannot~     continue antiretroviral treatment because of harmful side effects.~      For the first week of the study, participants will have a 1-week washout period in which~     they will receive no anti-HIV therapy. During this time, they will have physical, eye and~     neuropsychologic examinations, blood and urine tests, echocardiogram, electrocardiogram~     (EKG), chest X-ray, head CT scan and skin tests. These physical exams and tests will be~     repeated throughout the study to determine changes in health.~      After the washout period, patients will take capravirine once a day in the morning for 6~     days. After each dose, a small amount of blood will be drawn at 8 different times over 12~     hours to measure the activity of the drug and HIV blood levels. A heparin lock will be placed~     in the vein to avoid multiple needlesticks. After the 6 days of capravirine there will be~     another washout period, this time for 21 days. During this time, doctors will determine the~     optimum combination therapy for the individual patient.~      After the second washout, patients will begin combination therapy with capravirine plus at~     least two other anti-HIV medicines. (These may include a reverse transcriptase inhibitor such~     as zidovudine, didanosine, lamuvidine, zalcitabine, or stavudine, and maybe one or more~     protease inhibitors such as ritonavir, nelfinavir, saquinavir, indinavir or amprenavir.) For~     the first week, patients will have a daily blood test to determine HIV blood levels.~     Afterwards, treatment will continue on an outpatient basis with clinic visits every 4 to 8~     weeks for physical exams, lab tests and other procedures as required. The study will last~     approximately 48 weeks. Patients who benefit from capravirine therapy may be able to continue~     to receive the drug from the drug company sponsor or as part of another study, or the~     protocol for this study may be amended to lengthen the treatment period.~   "
273380|NCT00006518|"~     BACKGROUND: A number of important scientific advances can be made through the study of blood,~     bone marrow, tumor, or other tissue samples from patients with HIV infection, infection with~     Kaposi s sarcoma associated herpesvirus (KSHV), infection with other oncogenic viruses, or~     cancer. This protocol provides a mechanism to effect a variety of such studies.~      OBJECTIVES: Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue~     samples from patients with HIV infection, KSHV infection, or with cancer.~      ELIGIBILITY: Eligibility criteria include age 18 years or older and at lest one of the~     following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV~     seropositive; HTLV-1 seropositive; malignancy, Castleman s disease, or skin lesions with~     appearance of Kaposi s sarcoma; or cervical or anal intraepithelial lesion.~      DESIGN: Blood samples may be collected at the initial visit, and at follow-up visits. Tumor~     samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid,~     by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal~     risk to the patients. Specific risks will be described in a separate consent to be obtained~     at the time of the biopsy. Samples will be studied in the HIV and AIDS Malignancy Branch,~     CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators.~   "
273381|NCT00006517|"~     We are offering non-pharmacologic therapy for alleviation of symptoms associated with~     depressed mood that recurs annually in fall or winter. The treatments are self-administered~     at home by the patient, with close clinical supervision. Our trials use specially designed~     devices that replenish two different environmental elements, naturally occurring light and~     negative ions in the air. Both factors may be reduced in winter, bringing on depression.~   "
273382|NCT00006516|"~     This study examines the potential benefits of a home stimulation program to treat infants who~     have suffered from brain asphyxiation (lack of oxygen). The program involves one year of~     stimulatory activities. Progress will be evaluated through neurological and behavioral exams.~   "
273383|NCT00006515|"~     This study will examine late effects of treatment for sarcoma (bone and soft tissue cancers)~     in children. Survival of patients with these diseases has improved over the years, but~     long-term adverse effects of treatment have also been noted.~      Patients previously treated for sarcoma in the NCI's Pediatric Oncology Branch who are in~     their first remission from sarcoma after completion of therapy and who have had no further~     cancer treatment (chemotherapy, radiation therapy, cancer related surgery or immunotherapy)~     for at least 24 months may be eligible for this 3- to 4-day study. It will review the~     incidence and extent of the following late effects of therapy.~        -  Heart problems-The chemotherapy drug doxorubicin can cause acute and late injuries to~          the heart muscle. Patients will undergo magnetic resonance imaging (MRI) of the heart to~          look for changes and compare the findings with information obtained by standard~          echocardiogram (ultrasound test of the heart) and by MUGA (nuclear medicine scan of the~          heart).~        -  Gonadal dysfunction-The chemotherapy drug cyclophosphamide may affect sex hormone~          production, leading to infertility, early menopause or brittle bones. Low sex hormone~          levels may also increase the risk for heart attack, obesity or fracture. Patients will~          have blood tests to measure hormone levels as well as mineral levels, lipid levels and~          blood cell counts. They will also have a DEXA scan to measure bone mineral density and a~          CT scan of the abdomen to evaluate the distribution of fatty tissue in the abdomen.~          Males will be offered a semen analysis as part of the fertility evaluation.~        -  Psychosocial problems- Cancer diagnosis and treatment pose a major life stress that can~          lead to problems with personal relationships, jobs, insurance, education, health care,~          and personal and professional goal setting. Some patients may become depressed or~          develop a psychiatric illness. Patients will fill out a questionnaire about their~          treatment, recovery, and aspects of their current life and will meet with a psychologist~          and psychiatrist.~        -  Changes in bodily function and capabilities-Patients who undergo surgery and radiation~          to treat sarcoma treatment may experience muscle, bone and joint changes. Patients will~          be interviewed about their performance of daily activities, physical limitations, and~          changes in skill levels. They will do a series of exercises and will have measurements~          of strength, mobility and physical skills, focusing on the parts of the body that were~          affected by the sarcoma and subsequent local therapy.~        -  Exposure to viruses-A number of patients received blood transfusions as part of their~          cancer treatment. Some transfusions were given before HIV screening became available.~          Patients will be tested for this virus as well as the hepatitis virus and HTLV-1 (human~          T-cell leukemia virus-1), for which there are also small transfusion-associated risks.~        -  Kidney function-The chemotherapy drug ifosfamide may affect kidney function. Patients~          will provide a urine specimen for kidney function tests.~        -  Immune function-Chemotherapy affects the function of infection-fighting immune cells~          called T-lymphocytes. A blood sample will be drawn for studies of the time involved in~          recovering full immune function.~   "
273384|NCT00006514|"~     To statistically examine cardiovascular disease (CVD) risk in different populations based on~     data from studies representing national samples, cohort studies, and clinical trials.~   "
273385|NCT00006513|"~     To assess the population burden of occupational exposures in the prevalence and progression~     of chronic obstructive pulmonary disease (COPD).~   "
273386|NCT00006512|"~     To identify the predisposing genes responsible for asthma and bronchial hyperresponsiveness~     (BHR) at region 5p13.3 in an inbred Hutterite community.~   "
273387|NCT00006511|"~     To identify gene variants in human chromosome 5Q31-33 that may be involved in the~     pathogenesis of asthma.~   "
273388|NCT00006510|"~     To identify susceptibility genes associated with asthma and asthma related phenotypes.~   "
273389|NCT00006508|"~     We wish to identify people with hypoglycemia (low blood sugar) and ultimately determine why~     the blood sugar levels are so low. To do so, we will contrast the responses of patients~     suspected to have hypoglycemia with those of healthy subjects during standardized tests.~     Those tests may include: 1) a controlled hypoglycemia produced by administration of insulin,~     a blood sugar-lowering hormone, and sugar, 2) a formula meal, and 3) a period of up to 72~     hours without food.~   "
273390|NCT00006505|"~     This study will test whether a new islet transplant procedure will enable patients with type~     1 diabetes mellitus to stop insulin therapy. Islets are cell clusters in the pancreas that~     contain insulin-producing cells. The new procedure features three important advances, first~     developed by a group in Edmonton, Canada, over the way islet transplants have traditionally~     been performed: 1) the islets are transplanted immediately after they are removed from the~     donor; 2) islets are transplanted from two different donors in order to obtain the number of~     islets in a normal pancreas; and 3) the anti-rejection drug regimen is designed to reduce the~     harmful side effects of conditioning chemotherapy. (In the standard transplant procedure,~     patients receive intensive chemotherapy following the transplant. This study will use no~     radiation and lower-dose chemotherapy.)~      Patients between the ages of 18 and 65 with the diagnosis of type 1 diabetes mellitus for at~     least 5 years may be eligible for this study. Candidates will be screened with a medical~     history and physical examination, blood tests, chest X-ray and tuberculin skin test,~     electrocardiogram and exercise test for heart function, abdominal ultrasound, psychological~     evaluation, and an arginine stimulated c-peptide test. The latter test determines if the~     patient is producing any insulin. Eligibility is restricted to patients who make no insulin~     at all.~      The study has an active phase lasting 15 months and follow-up that continues indefinitely.~     Patients will receive 10,000 islet equivalents per kilogram (2.2 pounds) of body weight.~     This will likely require two separate transplant procedures from two donors. Before the first~     surgery, patients will be given anti-rejection (immune suppressing) drugs, including FK506~     and rapamycin (orally) and daclizumab (intravenously). The islets will be infused through a~     tube placed in the portal vein (the large vein that feeds the liver). After surgery, patients~     will receive insulin intravenously for 24 hours. They will then have an abdominal ultrasound~     and blood tests to determine liver function. If fewer than 10,000 islets were transplanted,~     patients will continue insulin treatment, with the dosages adjusted to account for the~     transplanted islets. They will take Daclizumab every 2 weeks, and FK506 and rapamycin daily.~     Blood tests to follow how much of these drugs are in the blood stream will be performed daily~     at first and then weekly after blood levels of these drugs stabilize. They will be given~     antibiotics to prevent infections. The arginine test will be repeated 2 weeks after the~     transplant and periodically thereafter. Blood will be drawn weekly to check drug levels, and~     monthly for other tests. The investigators will track daily insulin requirements, and these~     will be recorded monthly.~      Patients who require a second transplant to achieve the required amount of islets will return~     for the procedure when a compatible organ is donated. The second procedure will be done as~     described above. As before, insulin will be infused for 24 hours following surgery. It will~     then be stopped, however, and will not be resumed unless blood glucose levels reach above 180~     milligrams/deciliter. Patients will continue taking FK506 and rapamycin indefinitely.~     Daclizumab will be given every 2 weeks for 4 doses following the second transplant, and then~     stopped. Patients will take an antiviral called ganciclovir for 14 weeks and another~     antibiotic for 1 year following surgery. For the first year after surgery, patients will have~     frequent blood tests to monitor drug levels and immune function. They will return to NIH for~     a complete history and physical examination 2 and 3 years after the final islet transplant~     and will be contacted yearly by phone to ascertain their general health status and whether~     they remain insulin independent.~   "
273391|NCT00006504|"~     To determine the association between flavonoids intake and the prevention of incident~     cardiovascular disease (CVD).~   "
273392|NCT00006503|"~     To evaluate subclinical atherosclerotic disease in menopausal women.~   "
273393|NCT00006502|"~     To determine whether an impairment of myocardial perfusion reserve is an early indicator of~     coronary artery disease.~   "
273394|NCT00006501|"~     To evaluate whether T Wave Alternans can predict ventricular arrhythmias and sudden cardiac~     death (SCD) in a prospective epidemiologic natural history study.~      The prospective epidemiologic pilot study included 550 patients that had left ventricular~     dysfunction and no history of sustained ventricular arrhythmias. The primary hypothesis~     tested was whether there was an increased risk of having an arrhythmic event when T Wave~     Alternans was present in the patient. The secondary aims included comparing risk due to T~     Wave Alternans between the ischemic patients and non-ischemic patients and assessing whether~     T Wave Alternans remained an independent predictor of risk upon adjustment for other known~     risk factors for arrhythmic events such as ejection fraction, ventricular ectopy, NSVT,~     average NN interval, and RR interval variability.~      The study approach was a standard epidemiologic surveillance technique. The subject~     population consisted of individuals with Class I to III heart failure who will underwent a~     TWA and Holter monitor test and then were followed for up to two years or until arrhythmic~     events occured.~   "
273395|NCT00006500|"~     To examine trends in trans-fatty acid intake by using newly available nutrient data to~     recalculate 24 dietary recalls from the Minnesota Heart Survey.~   "
273396|NCT00006499|"~     To define the underlying genetics of hypertension in an Asian population by studying~     intermediate phenotypes.~   "
273400|NCT00006494|"~     The purpose of this study is to determine how laboratory tests called genotyping and~     phenotyping assess the effectiveness of antiretroviral drugs used to treat HIV infection.~     Some HIV-infected patients have measurable levels of virus in their blood even though they~     are taking combination drug therapy-including didanosine, stavudine, or efavirenz-against~     HIV. Genotyping and phenotyping can be used to test for resistance to a specific drug,~     thereby providing information that can help doctors decide on optimal drug treatment for a~     given patient. Genotyping identifies mutations, or changes, the virus undergoes that allow it~     to continue to grow despite drug treatment. Phenotyping involves growing the virus in test~     tubes with different amounts of drug and then calculating how much drug is required to stop~     its growth.~      Patients 18 years of age and older with HIV infection and viral levels between 5000 and~     100,000 copies per milliliter of blood who have been taking antiretroviral therapy for at~     least 6 months may be eligible for this study. Candidates will be screened with a urine test~     and various blood tests, including genotyping and phenotyping.~      Participants will have a series of tests to determine whether or not a drug is active against~     HIV. This involves temporarily stopping the drug under study (i.e., either efavirenz or~     didanosine or stavudine). The study procedure is as follows:~        1. Patients will have six blood tests over 10 days to measure viral load while on all~          current anti-HIV medications. On one of those days two blood tests will be done to~          measure levels of didanosine or stavudine. Efavirenz will also be measured if this drug~          is to be stopped.~        2. The patient will temporarily stop the drug under while continuing to take the other~          drugs. (Efavirenz will be stopped for 3 weeks; stavudine and didanosine will be stopped~          for 2 weeks.) Seven blood tests will be done at the following intervals to measure viral~          load: For patients who stop efavirenz, blood will be drawn on days 13, 18, 20, 22, 24,28~          and 30. (Day 0 is the first day of the study.) Patients who stop stavudine or didanosine~          will have blood drawn on days 11, 13, 15, 17, 19, 22 and 24. Repeat genotype and~          phenotype testing will also be done during this time, and a CD4 count (measurement of a~          certain type of white blood cell) will be done at the end of this 2- or 3-week period.~        3. The drug that was stopped will be restarted and viral load tests will be repeated. For~          pati...~   "
273401|NCT00006493|"~     The purpose of this research is to study the effects of rosiglitazone, a drug usually taken~     for Type II diabetes, on HIV-associated hyperlipidemia. HIV-associated lipodystrophy is a~     medical condition characterized by gradual changes in the distribution of body fat. The body~     fat located in the extremities and face disappears while body fat around the abdomen and~     upper back increases. Certain biochemical changes occur in association with these changes in~     fat distribution. Lipid levels particularly serum triglycerides are increased. HDL, the good~     cholesterol is decreased. Higher than normal level of insulin or insulin resistance is also~     found in this condition. This latter condition is one of the hallmarks of Type II diabetes.~     The protease inhibitors, a class of HIV medications, are associated with the occurrence of~     HIV-associated lipodystrophy. It has been suggested that a biochemical pathway known as the~     peripheral peroxisomal activating receptor (PPAR) gamma system is blocked leading to the~     onset of this condition.~      Rosiglitazone is a new drug approved by the FDA in 1999 for the treatment of type II~     diabetes. It lowers blood sugar by improving insulin resistance, which as mentioned before,~     is the hallmark of Type II diabetes. It has also been noted to improve blood lipid levels.~     Rosiglitazone works by stimulating the PPAR gamma system. It is hoped that this drug can turn~     on the PPAR system and reverse the HIV-associated lipodystrophy syndrome.~   "
273402|NCT00006492|"~     This study will screen patients with cerebellar ataxia to check for antibodies that indicate~     allergy to gluten (wheat protein) and will study the effect of a gluten-free diet in patients~     with these antibodies. Patients with cerebellar ataxia have problems with coordination,~     resulting in clumsiness and unsteadiness of posture and walking.~      There are many known causes of cerebellar ataxia, but in many patients the cause is unknown~     and there are no available treatments. Cerebellar ataxia has been recognized as a~     complication of celiac disease, a syndrome characterized by sensitivity to gluten.~     Recognizing gluten sensitivity in patients with cerebellar ataxia would be important for two~     reasons: it would be one of the rare causes of the disease that are potentially treatable,~     and it would identify patients at risk for developing gastrointestinal cancers, particularly~     intestinal lymphoma.~      Patients with cerebellar ataxia of known or unknown cause and normal healthy volunteers of~     any age are eligible for this study.~      All participants will have a medical history, physical examination, blood drawn (30~     milliliters, or 2 tablespoons) to check for celiac disease antibodies, and possibly other lab~     tests. This completes the participation of normal volunteers.~      All patients will have magnetic resonance imaging (MRI) of the brain. This diagnostic tool~     uses a strong magnetic field and radio waves instead of X-rays to show structural and~     chemical changes in tissues. During the scanning, the patient lies on a table in a narrow~     cylinder containing a magnetic field. He or she can speak with a staff member via an intercom~     system at all times during the procedure. Scanning times vary from 20 minutes to 2 hours.~      Patients who have celiac disease antibodies will have an upper gastrointestinal (GI)~     endoscopy intestinal biopsy. For this procedure, a flexible tube is inserted into the mouth~     and down the throat into the stomach and duodenum (the upper part of the small intestine),~     where a small tissue sample is taken for microscopic examination. Patients with these~     antibodies will be put on a gluten-free diet and will be followed at NIH every 3 months for~     12 months. On the first visit, patients will have their ataxia evaluated using NINDS's ataxia~     scale and will meet with a dietitian for instructions for a gluten-free diet. On the second~     through fifth visits (after 3, 6, 9 and 12 months, respectively, on the gluten-free diet),~     patients will have their ataxia evaluated, speak with a dietitian to assess their nutritional~     status, weight, and compliance with the diet, and provide a blood sample for celiac disease~     antibody testing.~      At the completion of the study, patients may choose to continue or stop the gluten-free diet.~     If the ataxia assessments show improvement, patients will be advised to continue the~     gluten-free diet permanently.~   "
273403|NCT00006489|"~     This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol~     dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a~     6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial~     therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced~     medication management intervention will accompany all treatment conditions. Follow-up~     assessments will be completed at 9 and 12 months after treatment.~   "
273404|NCT00006488|"~     Parkinson's disease is characterized by loss of neurons that produce dopamine in a region of~     the brain called the substantia nigra. In the early stages of the disease, the disease~     responds to agents that replace dopamine such as levodopa. Patients with more advanced~     disease have wide fluctuations in their response to levodopa, exhibiting on and off periods.~     This is due to continued degeneration of neurons. Recombinant-methionyl human glial cell~     line-derived neurotrophic factor (r-metHuGDNF or GDNF) is a neurotrophic factor that promotes~     survival of dopaminergic neurons. This is a protein produced by recombinant technology that~     is almost identical to the naturally produced factor. Results of animal studies indicate that~     GDNF has the potential to benefit patients with advanced Parkinson's disease.~      The purpose of this clinical trial is to determine whether GDNF works to relieve symptoms of~     advanced Parkinson's disease. The study will also test the delivery of GDNF using a catheter~     implanted into the putamen, the area of the brain associated with Parkinson's disease, and an~     infusion pump that is implanted under the skin in the abdomen or chest. GDNF will be placed~     into the pump and delivered through the catheter to the brain. The purposes of this study are~     to determine the potential benefits and side effects of GDNF. The performance and safety of~     the catheter/infusion pump system will also be assessed. The study will last for 6 months.~     Subjects will undergo neurological testing, computerized gait assessment and neurological~     imaging.~   "
273572|NCT00006059|"~     OBJECTIVES:~      I. Determine the chromosomal regions that contain genes that raise the risk of epilepsy in~     families by performing genetic linkage analysis of idiopathic/cryptogenic epilepsy.~   "
273665|NCT00005722|"~     For State Health Departments located in Stroke Belt states, to assess high risk target~     audiences' needs and identify opportunities for more effective delivery of medical and/or~     educational services to reduce the high rate of stroke mortality experienced in the~     southeastern United States.~   "
273405|NCT00006450|"~     This study will examine the safety and effectiveness of treating brain tumors in children~     with a continuous infusion of phenylbutyrate. A breakdown product of this drug,~     phenylacetate, is normally found in low concentrations in the blood. At much higher~     concentrations, phenylbutyrate and phenylacetate are active against cancer in animals.~      Patients between 2 and 21 years old with a brain tumor that has progressed or recurred after~     radiation or chemotherapy, including bone marrow transplant, may be eligible for this study.~     Candidates will be screened with a medical history and physical examination, blood tests,~     magnetic resonance imaging (MRI) or computerized tomography (CT) of the head and, if needed,~     a spinal fluid test and bone marrow test.~      Study participants will have a continuous infusion of phenylbutyrate for two 28-day~     cycles-every day, 24 hours a day, 7 days a week. The medicine will be infused through a thin~     tube (catheter) placed in a large vein in the upper chest, delivered through a portable~     infusion pump. Patients will be hospitalized for at least 3 days when the treatment begins.~     If there are no side effects at that time, the infusions can continue on an outpatient basis.~     The patient or care giver will receive the medicine in 4-day supplies and will be taught how~     to change the bag and tubing daily for drug administration, as well as how to use the~     infusion pump. Patients will be monitored with weekly blood tests to look for side effects~     and measure blood levels of phenylbutyrate. They will have a physical examination at least~     once a week. At the end of the second 28-day cycle, patients will have a CT or MRI scan to~     evaluate the tumor's response to treatment. Patients whose tumor has grown will stop~     treatment and come off the study. Those whose tumor has remained stable or shrunk may~     continue phenylbutyrate as long as the treatment is beneficial and there are no serious side~     effects. CT or MRI scans will be done after every 2 cycles (or sooner if needed) to evaluate~     the treatment.~      Patients with certain tumor types (medulloblastoma, PNET, ependymoma, malignant germ cell~     tumor and pineoblastoma) or who have symptoms that indicate there might be tumor along the~     spinal cord may have a spinal tap. For this procedure, the patient lies on the side and a~     needle is inserted between two vertebrae (bones of the spine) in the lower back, into the~     cerebrospinal fluid space. A sample of fluid is drawn for testing for cancer cells. If the~     tumor has spread through the spinal fluid, a spinal tap will be done every other cycle (every~     2 months) to monitor the effects of therapy.~   "
273406|NCT00006449|"~     The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with~     two psychotherapies that differ in scope and intensity. The effect of these treatments will~     be assessed with patients who differ in their psychosocial need and resources at their~     disposal, and in their level of cravings for alcohol.~   "
273407|NCT00006507|"~     Children with Sensory Modulation Dysfunction (SMD) either over- or under-react to stimuli in~     their environment. This can cause significant problems with daily activities and may lead to~     anxiety, poor attention, low self-esteem, and further complications in motor, cognitive,~     social and emotional development. Diagnosis of SMD is based on physiological responses to~     specific stimuli, measures of behavioral/social/emotional symptoms, and studies of the~     resulting functional limitation and disability. Treatments involve direct biomedical and~     behavioral intervention to improve sensory processing, as well as adjustments to the home,~     school and community environment. This study will compare the effect of occupational therapy~     vs. alternative therapy on the reactivity and function of children who have SMD.~   "
273408|NCT00006448|"~     Pain is a major problem for people after spinal cord injuries and amputations. This is a~     study to test how pain is affected by adding methadone to a six-week program of weekly~     physical therapy, relaxation training and counseling. Individuals who qualify for this study~     will receive a comprehensive medical and physical therapy evaluation.~   "
273409|NCT00006447|"~     This randomized trial tested a 6 month intervention of computer network vs a control group~     (standard care) to improve quality of life and health status for traumatic brain injury (TBI)~     patients and their caregivers. The network, termed the Trauma Recovery Support System (TRSS),~     consisted of a central computer system connected via modem to a personal computer in the~     caregiver's home. Users could access via the Internet special modules and communication~     services to help them cope with their new roles as caregivers and with accompanying social~     isolation. These modules were an on-line discussion group, an ask an expert questions~     function, a database of previously asked questions with answers, a database of community~     resources, and a reference library.~   "
273410|NCT00006446|"~     Children who are at risk for problems in school may do better if they and their parents are~     taught how to communicate with each other between age 3 and 6 when the children enter~     kindergarten. Three groups of 3 year olds who are in Head Start in the Nashville area will be~     randomized with their parents to either a 3 year program of skill building or to a control~     (Head Start only). The children will be tested at the end of the 3 year study and 6 months, 1~     year and 2 years later.~   "
273411|NCT00006445|"~     Too much or too little genetic information (chromosome material) can cause abnormal~     development of the fetus or death. Each year approximately 2.5 million pregnant women are~     screened for Down Syndrome using invasive screening methods (amniocentesis or chorionic~     villus sampling). This 11 center study of 38,000 women will compare the accuracy of the~     several non-invasive tests in the first and second trimesters of pregnancy versus~     amniocentesis or diagnosis at birth to diagnose aneuploidy or Down Syndrome.~   "
273412|NCT00006439|"~     Adherence to complex medication regimens is critical to successful treatment of HIV~     infection. Unfortunately, adherence to medical regimens with conventional interventions~     averages 50% in chronic disease. We have observed that adherence barriers that were~     unrecognized by providers in the clinic setting have been detected during home visits. It is~     possible that recognition and interventions to resolve adherence barriers observed during~     home visits may improve adherence. This proposal will test the hypothesis that home-visits~     which identify previously unrecognized adherence barriers and provide support and education~     will increase medication adherence among children and youth with HIV infection and improve~     the patient/health care provider relationship. Specific aims of the study are: 1. Determine~     the impact of a series of home-visits on adherence to medication regimens for HIV infected~     youth and children. 1a. Adherence to medical regimens will be assessed before and after the~     series of home-visits using a self-report questionnaire and Microelectronic Monitoring System~     (MEMS) or in-home pill count. 1b. For each of these measures a percentage of adherence will~     be calculated and compared from a baseline to after the final home visit and after the six~     month follow up period. 2. Assess the changes in patient satisfaction from baseline to after~     the home-visits using a questionnaire completed by the patient/family. 3. Incorporate a pilot~     study to assess the changes in the provider's knowledge of the patient's family~     characteristics and home circumstances relevant to adherence following the home visits.~   "
273413|NCT00006438|"~     The purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles~     help people with foot deformities to walk better. This study will use modern gait lab~     techniques to measure the forces on the bottom of the feet and to examine whether there is~     any effect higher on the leg from the rocker soles.~   "
273666|NCT00005721|"~     To retain individuals as blood donors once they have entered the voluntary blood donation~     system and to increase the frequency of their donations.~   "
273414|NCT00006437|"~     This study will compare blood from healthy volunteers and with wound fluid and tissue samples~     from patients with acute and chronic wounds enrolled in other NIH studies. Chronic wounds,~     such as venous leg ulcers, pressure sores, ischemic ulcers and diabetic foot ulcers, affect~     more than 4 million Americans each year and cost about $9 billion to treat. The nature of~     these wounds is not well understood and treatments are not always successful, for unknown~     reasons. Blood collected from healthy volunteers will be used to prepare a model for studying~     various processes involved in wound healing.~      Normal healthy volunteers 21 years of age and older who do not smoke and have no medical~     problems of the heart, bones, muscles, stomach, lungs, blood, or nervous system, do not have~     problems going to the bathroom, and have no infections may be eligible for this study.~      Participants will be interviewed briefly for information on their date of birth, gender,~     ethnic identity and medical history and will have a brief physical examination, including a~     check of height and weight, vital signs and heart and lung sounds. About 14 milliliters (2~     tablespoons) of blood will be drawn from the arm.~   "
273415|NCT00006436|"~     Background:~        -  HIV-infected patients have a weakened immune system, and chemotherapy, which is used to~          treat lymphoma, probably causes further damage to the immune system.~        -  Limiting the amount of immune damage due to chemotherapy might decrease the number of~          infections and the risk of developing cancer in the future in HIV-infected patients with~          non-Hodgkin's lymphoma.~      Objectives:~        -  To determine whether reducing the total amount of chemotherapy using a specific~          combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine,~          cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing~          the risk of infections and future cancers.~        -  To determine whether the lymphoma will remain undetectable for at least one year if~          treatment is stopped one cycle after the patient enters remission.~      Eligibility:~      -Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not~     been treated previously with rituximab or cytotoxic chemotherapy.~      Design:~        -  Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than~          six cycles.~        -  The lymphoma is evaluated using CT and PET scans at the end of treatment cycles 2 and 3.~          A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on~          screening for participation in the study.~        -  Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R~          treatment ends.~        -  Patients are monitored for treatment response with blood tests and imaging scans at~          baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6~          months for a total of 24 months following chemotherapy.~   "
273416|NCT00006435|"~     Background:~      -Plexiform neurofibromas in patients with NF1 are a significant cause of morbidity but little~     is known about the natural history of these lesions.~      Objectives:~        -  The purpose of this study is to monitor the natural history of plexiform neurofibromas~          and to evaluate the usefulness of volumetric MRI tumor measurements in this disease.~        -  Other goals of the study are to provide a body of normative data on the growth rate of~          plexiform neurofibromas and to establish a tissue repository and pathology review center~          to allow future studies of the pathogenesis of neurofibromas and clinical trials of~          potential therapeutic agents.~      Design~      - This study is coordinated by Dr. Bruce Korf, and was initiated when he was at the Partners~     Center for Human Genetics, Boston, MA.~   "
273417|NCT00006434|"~     When patients relapse after primary chemotherapy for Non-Hodgkin's lymphoma, they may be~     eligible to receive high-dose chemotherapy with autologous stem cell support. Unfortunately~     high-dose chemotherapy is curative in less than half the patients who receive it. This study~     is being conducted to determine the safety, side effects, and the ability to respond to an~     investigational vaccine that consists of tumor-pulsed dendritic cells given with an immune~     stimulating drug called interleukin-2. The patient must have a lymphomatous node accessible~     for excision to prepare the vaccine. Dendritic cells are immune cells that are obtained from~     the blood, and are important in the body's immune response to foreign substances. This study~     will examine the response of the immune system after three vaccinations (composed of~     dendritic cells, which have been exposed to dead fragments of lymphoma cells) given beginning~     three months after transplant. Vaccination may result in sensitizing the patient's dendritic~     cells to his lymphoma cells, potentially resulting in an immune response against the~     lymphoma. Twelve patients will be treated on study.~   "
273418|NCT00006433|"~     Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy~     and heat treatment for recurrent breast cancer located on the chestwall following mastectomy.~     This protocol also includes patients with metastatic breast cancer who have not had~     mastectomy but have advanced tumor remaining within the breast. Doxil is the drug adriamycin~     (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount~     of lipid (fat). This chemotherapy is in a newer form which can be better delivered to the~     tumor tissue without causing as much systemic toxicity. We are combining heat treatment with~     this drug in an effort to further increase the delivery of drug to the tumor, which may give~     an increased tumor response.~      Methods: The patients will be treated with chemotherapy followed by heat treatment. This will~     be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to~     be hospitalized 3 days for measurement of blood levels of drug as well as some additional~     radiology studies which will help us to determine whether the drug is preferentially~     distributed within tumor.~   "
273486|NCT00006285|"~     The purpose of this study is to learn more about how the brain allows people to focus on~     important objects and filter out unimportant ones when looking at visual images.~      Our senses provide us with a vast amount of information at any given moment in time. For~     example, visual scenes contain many different objects that cannot be processed simultaneously~     because of the limited processing capacity of the brain's visual system. Evidence suggests~     that a a network of brain regions selects relevant information and filters out irrelevant~     information when people view cluttered visual scenes. This study will use transcranial~     magnetic stimulation (TMS) and functional magnetic resonance imaging (fMRI) to determine how~     the different brain regions involved in attentional control and filtering interact.~      Participants in this study will undergo computer tests, an MRI scan, and TMS. During the MRI,~     participants will look at pictures and count objects appearing on a screen. During the TMS,~     participants will perform a computer test. Participants' ability to pay attention will be~     tested with and without TMS. Participants may be asked to return for additional tests in the~     future....~   "
273419|NCT00006432|"~     There is some consensus that high fat diets can contribute to the development of obesity and~     type 2 diabetes in humans and animals. An increase in dietary fat has been shown to produce~     obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat~     in the diet. In humans, there is some evidence that low-fat diets can produce acute~     improvements in blood sugar control in type 2 diabetes-even in the absence of weight loss. In~     most human studies, however, dietary fat reduction has been accompanied by a reduction in~     total calorie intake. It is thus not possible to separate the effects of these 2 metabolic~     changes. The purpose of this study is to gather preliminary information on the effect of a~     very-low-fat diet on blood metabolism in persons with type 2 diabetes. The design~     incorporates controlled feeding procedures, and 30 men and women with type 2 diabetes will be~     given all foods for 4 weeks--a 2-week diet standardization period (diet composition: 35% fat,~     15% protein, 50% carbohydrate), followed by a 2-week experimental diet period. The~     experimental diet conditions are A) continuation of the moderately-high-fat standardization~     diet, or B) a very-low-fat diet composed of 10% fat, 15% protein, 75% carbohydrate. Outcomes~     will be measured after the standardization and the experimental periods. The primary outcome~     variable is fasting plasma glucose; secondary outcomes are fasting insulin, carbohydrate~     (meal) tolerance, insulin secretion and blood lipids. In addition, we will gather descriptive~     data on the potential acceptability and utility of a very-low-fat diet constructed using the~     fat substitute, olestra (sucrose polyester). There are no results yet.~   "
273420|NCT00006431|"~     The feasibility and dose-limiting toxicity of administering escalating doses of dendritic~     cells transfected with autologous renal cell carcinoma RNA DC(DCRCC-RNA) will be defined. As~     a secondary endpoint, the ability of DCRCC-RNA to induce tumor-specific immune responses will~     be evaluated. Finally, the anti-tumor effects measured by clinical response criteria, their~     duration and overall survival (calculated at 2-year follow-up) will be determined in each~     patient receiving dendritic cell therapy.~      Background: Prognosis in metastatic renal cell carcinoma is poor with a median survival of~     less than one year. Although renal cell carcinoma has shown some response to immunotherapy,~     the results of systemic administration of biologic response modifiers in disseminated renal~     cell carcinoma have been poor. Growing evidence suggests that active immunotherapy,~     particularly dendritic cells (DC) based vaccines, may prove to be a viable and clinically~     effective therapeutic option for patients with advanced or metastatic renal cell carcinoma.~   "
273421|NCT00006430|"~     Purpose: This protocol proposes a safety and feasibility trial in patients with metastatic~     prostate cancer (stages D1-D3) investigating the induction of antitumor immunity by~     administration of cultured autologous peripheral blood precursor derived dendritic cells~     (DC), transfected with mRNA amplified from autologous prostate tumor tissue. The feasibility~     and dose-limiting toxicity of administering escalating doses of tumor RNA transfected~     dendritic cells will be defined. As a secondary endpoint, the ability of tumor RNA~     transfected dendritic cells to induce tumor-specific immune responses will be evaluated.~     Finally, the anti-tumor effect based on PSA (biochemical) response criteria will be defined.~      Background: Because prostate cancer is incurable when metastatic and conventional therapies~     do not offer a clear survival benefit, new therapeutic strategies are warranted. This study~     is based on the premise that clinically effective cell mediated immune responses against~     prostate tumors can be elicited by activation of tumor associated antigen specific T cells.~     Work performed by others and our group suggests that PSA, a protein expressed in virtually~     all prostate cancers, can serve as a widely expressed candidate antigen for prostate cancer~     immunotherapy. In particular, we have shown that cultured dendritic cells transfected with~     mRNA encoding PSA are remarkably effective in stimulating antigen specific immunity in vitro.~     Therefore, we hypothesize that administration of PSA RNA transfected DC will lead to~     detectable levels of PSA specific CTL in the peripheral blood of patients with PSA expressing~     metastatic prostate cancer. It is hoped that these T cell responses also have clinical~     antitumor activity.~   "
273422|NCT00006429|"~     This is a trial to test whether treadmill training can be used to improve the walking of~     patients with partial spinal cord injury. While on the treadmill, patients will be partially~     supported through the use of a specially designed harness attached to an overhead lift (also~     called Body Weight Supported Treadmill Training, BWSTT). Patients who enroll in this study~     will be randomly assigned to either the experimental group, which receives 12 weeks of this~     specialized treadmill training with regular physical therapy, or to the control group, which~     receives 12 weeks regular physical therapy. The ability of the patients to walk will be~     measured before and after treatment as well as 6 and 12 months later, using standard tests~     that examine mobility independence and speed of ambulation. The trial takes place across five~     sites in the US and Canada. Patients eligible for this trial will have had a traumatic spinal~     cord injury within 8 weeks of trial entry.~   "
273423|NCT00006428|"~     This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic~     pain in adults that have had a spinal cord injury.~   "
273424|NCT00006427|"~     This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults~     that have had an amputation~   "
273425|NCT00006426|"~     People with diabetes often develop severe skin problems (ulcers) on their feet. Sometimes~     these are treated with surgery and other times by temporarily immobilizing the foot in a~     cast. This study compares the effect of surgery to lengthen the Achilles tendon and put the~     foot in a cast, to using a cast alone. The study will also examine how foot strength, joint~     movement, and overall ability to walk, balance and climb stairs is affected.~   "
273499|NCT00006204|"~     This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus~     fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will~     actively participate in the 6-month study, which includes weekly individual Dual Disorders~     Recovery Counseling during the first month and every two weeks during the second through~     sixth months, plus the naltrexone and fluoxetine or fluoxetine and placebo. Subjects will~     complete follow-up assessments at 9 and 12 months.~   "
273625|NCT00005765|"~     The objective of this protocol is to examine the utility of behavioral economics for~     understanding reinforcer interactions as they pertain to drug self-administration. In a~     series of 6 experiments, the researchers will attempt to quantify the effects of~     qualitatively different reinforcers (money, cigarettes, alcohol, nicotine gum) and their~     interactions. This work represents a continuation of research by this investigator in the~     area of addiction and pharmacology.~   "
273426|NCT00006425|"~     Women who carrying a BRCA1 or BRCA2 gene mutation or who are the first- or second-degree~     relative of an individual with a BRCA-associated cancer in a family documented to have a~     BRCA1 or BRCA2 mutation will be eligible for enrollment into this pilot study of breast~     cancer screening modalities. We will recruit up to fifty women (twenty-five women who carry~     an altered BRCA1 or BRCA2 gene and 25 non-carriers matched by age and family mutation type)~     with regular menstrual cycling (documented by menstrual history and premenopausal FSH level).~     A physical exam including exam of the breast and pelvis, a standard four view mammogram,~     breast MRI and PET scan will be scheduled initially during either the follicular or~     mid-luteal phase of the menstrual cycle. A unilateral cranio-caudal mammogram, and bilateral~     MRI and PET scan will be repeated three months after entry during the phase not initially~     studied. A CA125 and transvaginal color doppler ultrasonography will be done in the~     follicular phase. Carriers and non-carriers will be compared with respect to menstrual cycle~     differences in: (1) two measures of mammographic density (qualitative and semiquantitative);~     (2) a semiquantitative measure of fibroglandular volume (MRI); (3) a semiquantitative measure~     of contrast enhancement (MRI); and (4) FDG uptake measured over time (PET scan). On the~     initial and three-month visit, all participants will undergo breast duct lavage to~     investigate if there are consistent menstrual cycle differences in breast ductal cytologies.~     Participants will be seen annually thereafter for an additional three years of follow-up. A~     physical exam, standard four-view mammography, breast MRI, CA 125, transvaginal color doppler~     ultrasonography and breast duct lavage will be done annually. Consent for a PET study will be~     requested if an abnormality is detected on mammography or breast MRI requiring additional~     clinical or radiographic follow-up.~      Participants in the Menstrual Cycle Pilot Study, will complete a self-administered~     questionnaire and telephone interview and will complete periodic follow-up questionnaires to~     assess various behavioral and psychosocial endpoints.~      As part of the Menstrual Cycle Pilot Study, we will recruit 25 volunteers to assist in~     training study investigators in performing breast duct lavage. Cytologies obtained from~     volunteers will be used to develop oncogene probe panels to be used in the study.~   "
273427|NCT00006424|"~     This study will use magnetic resonance imaging (MRI) scans to explore how the brain changes~     (reorganizes itself) in response to learning and to brain lesions in healthy people and~     people with various physical disabilities.~      Normal volunteers and patients with disabilities including blindness, limb amputation,~     hemispherectomy (removal of a cerebral hemisphere), and stroke may be eligible for this~     study. Candidates will be screened with medical and neurological examinations.~      Participants will have MRI scans while they lie still or perform certain movements, as~     instructed. MRI uses a strong magnetic field and radio waves instead of X-rays to show~     structural and chemical changes in tissues. During the scan, the subject lies on a table in a~     narrow cylinder containing a magnetic field. He or she can speak with a staff member through~     an intercom system at all times during the procedure. All participants will first have a scan~     to show brain structure, which will take about 30 minutes. A second scan will measure blood~     flow or biochemical concentration and will take from 1 to 2 1/2 hours.~      Depending on their disability, patients will participate in one of the following tests:~        -  Blindness-This will study the ability of blind people to process tactile information.~        -  Stroke- This will study mechanisms underlying recovery of motor function after stroke.~          The patient will perform voluntary movements or remain still during the scan.~        -  Amputation- This will study mechanisms underlying the ability of the brain to reorganize~          after amputation. The patient will move different parts of the body or remain still~          during the scan.~        -  Hemispherectomy- This will study mechanisms underlying the ability of one side of the~          brain to control movements of both arms. The patient will make different kinds of~          movements during the scan.~      Normal volunteers will participate in one of the following tests:~        -  Use-dependent plasticity- This will evaluate the effectiveness of amphetamine and~          placebo in demonstrating brain flexibility. The volunteer will take an amphetamine or~          placebo (inactive pill) before the scan and then perform a specific exercise using the~          thumb.~        -  Motor fatigue- This will study the mechanisms that underlie fatigue, which affect many~          patients with neurological conditions. The volunteer will contract muscles in the~          forearm and hand for several minutes until he or she feels fatigue.~        -  Light deprivation- This will evaluate changes in the brain that occur after light~          deprivation. The volunteer will remain at rest in the scanner for up to 150 minutes.~        -  Somatosensory stimulation-This will examine whether stimulation of the wrist can cause~          changes in hand representation in the part of the brain that controls movement. The~          volunteer will make hand movements at different times during the test. In addition, mild~          electric shocks will be delivered to the wrist for up to 2 hours. Although the shock~          intensity is regulated to avoid pain, there may be some discomfort.~   "
273428|NCT00006422|"~     This study offers evaluation and treatment for patients with pediatric eye diseases,~     particularly amblyopia and strabismus. The protocol is not designed to test new treatments;~     rather, patients will receive current standard of care treatments. The purpose of the study~     is twofold: 1) to allow National Eye Institute physicians to increase their knowledge of~     inflammatory eye conditions and identify possible new avenues of research in this area; and~     2) to establish a pool of patients who may be eligible for new studies as they are developed.~     (Participants in this protocol will not be required to join a new study; the decision will be~     voluntary.)~      Patients age 6 months and older with pediatric eye diseases, including amblyopia, strabismus,~     cataracts, glaucoma, and developmental abnormalities may be eligible for this study.~     Candidates will be screened with a medical history, eye examination, and diagnostic~     procedures that may include routine laboratory testing, X-rays, questionnaires, physical~     examination, and other standard or specialized tests or procedures as needed. The eye~     examination includes measurements of eye pressure and visual acuity (ability to see the~     vision chart), examination of the pupils and eye movements, and dilation of the pupils to~     examine the lens and retina. In addition, patients will undergo a procedure to record eye~     movements called oculography, in which special detectors measure infrared light reflected off~     the patient's eyes while he or she watches lights on a computer screen.~      Participants will be followed for at least 3 years. Visits will be scheduled from 1 to 6~     times a year, according to the standard of care for the individual patient's eye problem.~     Vision will be checked at each visit, and some of the screening tests described above may be~     repeated to follow the progress of disease and evaluate the response to treatment.~   "
273429|NCT00006421|"~     This study will explore new screening methods for early detection of breast and ovarian~     cancer in women at high risk for these diseases, because they have an altered breast cancer 1~     (BRCA1) or breast cancer 2 (BRCA2) gene. It will also try to determine if breast tissue~     characteristics in women with a BRCA1 or BRCA2 mutation differ from those in women with a~     normal gene.~      Premenopausal women between 25 and 45 years of age who have participated in National Cancer~     Institute studies for families or individuals at high genetic risk of cancer (78-C-0039 or~     99-C-0081) and who have at least a 50 percent probability of carrying an altered BRCA1 or~     BRCA2 gene may be eligible for this study.~      At the first visit, participants will have from 4 to 24 tablespoons of blood drawn and will~     be interviewed about breast and ovarian cancer risk factors, family and personal history of~     cancer, history of pregnancies, use of oral contraceptives and other hormones and drugs, and~     previous surgery on the breasts and ovaries. In addition, they will undergo the following~     procedures:~      Routine breast and ovarian cancer screening for high-risk women, including a mammogram,~     breast and pelvic exam, instruction in breast self-examination, CA 125 blood test and~     transvaginal ultrasound of the ovaries.~      Magnetic Resonance Imaging (MRI) of the breast MRI uses a strong magnetic field to show~     structural and chemical changes in tissues.~      Breast Duct Lavage In this procedure samples of fluid and cells from the lining of the breast~     milk ducts are collected to look for cancerous or pre-cancerous cell changes.~      Positron Emission Tomography (PET) scan PET scanning will be done only in participants whose~     mammogram or MRI findings require additional evaluation. This diagnostic test is based on~     differences in how cells take up and use glucose (sugar), one of the body s main fuels.~      Annual follow-up visits will be scheduled for 3 years and will include routine high-risk~     screening as described above, blood draw, update of family history and risk factors, breast~     MRI, breast duct lavage and, if there are changes on the MRI or mammogram that need further~     evaluation, the PET will be repeated.~   "
273430|NCT00006420|"~     To continue surveillance of coronary heart disease (CHD) mortality and morbidity in the seven~     county metropolitan Minneapolis/St. Paul (Twin Cities) areas.~   "
273431|NCT00006419|"~     To examine the relationship of specific dietary factors to risk of chronic obstructive~     pulmonary disease.~   "
273432|NCT00006418|"~     This study will create a DNA collection with blood samples from families with at least two~     siblings who have schizophrenia symptoms. This collection will help scientists identify genes~     that predispose people to schizophrenia.~   "
273433|NCT00006417|"~     This study will investigate the safety and effectiveness of a new stem cell transplant~     procedure for treating chronic granulomatous disease (CGD) in patients with active infection.~     CGD is an inherited disorder of neutrophils-a type of infection-fighting white blood~     cell-that leaves patients vulnerable to life-threatening infections. Standard treatment with~     antibiotics, and sometimes surgery, is not always successful, and patients with persisting~     infections have a poor long-term prognosis.~      Transplantation of donated stem cells (cells produced by the bone marrow that mature into the~     different blood components-white cells, red cells and platelets) can cure CGD. However, this~     procedure carries a significant risk of death, particularly in patients with active~     infection, because it requires completely suppressing the immune system with high-dose~     chemotherapy and radiation. In addition, lymphocytes-another type of infection-fighting white~     blood cell-from the donor may cause what is called graft vs. host disease (GvHD), in which~     the donor cells see patient's cells as foreign and mount an immune response to reject~     them. To try to reduce these risks, patients in this study will be given low-dose~     chemotherapy and no radiation, a regimen that is easier for the body to tolerate and involves~     a shorter period of complete immune suppression. Also, the donor's lymphocytes will be~     removed from the rest of the stem cells to be transplanted, reducing the risk of GvHD.~      Patients with CGD between the ages of age 1 and 55 years old who have an active non-viral~     infection may be eligible for this study. They will have a medical history, physical~     examination and blood tests (including testing for adequacy of the genetic match with the~     donor). A bone marrow sample will be taken to evaluate disease status. This test, done under~     a local anesthetic, uses a special needle to draw out bone marrow from the hipbone. A central~     venous catheter (flexible plastic tube placed in a vein) will be put in place before~     treatment begins. It will be used to draw and transfuse blood, give medications, and infuse~     the donated stem cells.~      Several days before the transplant procedure, patients will start low-dose chemotherapy with~     cyclophosphamide and fludarabine, two commonly used anti-cancer drugs. They will also be~     given anti-thymocyte globulin to prevent rejection of the donated cells. When this~     conditioning therapy is completed, the stem cells will be infused through the central line.~     Patients will be given cyclosporine 4 days before and 3 months after the stem cell transplant~     to help prevent rejection.~      About 3 weeks after the transplant, patients will be discharged from the hospital. They will~     return for follow-up clinic visits weekly and then twice weekly for 3 months. These visits~     will include a symptom check, physical examination, and blood tests. Blood transfusions will~     be given if needed. Subsequent visits will be scheduled at 4, 6, 12, 18, 24, 30 and 36 months~     after the transplant, or more often if required, and then yearly.~   "
273500|NCT00006203|"~     This 5-week study will examine the effects of naltrexone on alcohol craving, drinking rates,~     and reaction to drinking-related triggers, or cues, in participants' everyday environment and~     in laboratory sessions. Participants will monitor and record their daily desires to drink,~     environmental circumstances in which urges occur, and drinking behavior using a palm top~     computer. Participants will receive naltrexone or a placebo. One week after receiving~     medication, all participants will be asked to respond to alcohol-related cues that may or may~     not arouse the desire to drink.~   "
273434|NCT00006414|"~     This study will examine the effectiveness of an experimental treatment to improve hand~     function in patients who have had a stroke affecting one side of the body. One of the main~     problems of stroke patients is difficulty using the affected hand. Most treatments focus on~     acute (early) intervention, although special exercises may help some chronic patients.~     Previous studies have indicated that combining hand exercises with anesthesia (blocking motor~     and sensory function) of the upper arm may improve hand movement in stroke patients, even in~     the chronic state. This study will examine whether the exercise plus anesthesia treatment is~     more beneficial for these patients over the long-term than exercise alone.~      Patients 18 years or older who are at least 12 months post stroke, which has affected only~     one side of the body, may be eligible for this study. Candidates will have a medical history~     and physical and neurological examinations.~      Participants will be randomly divided into two groups: one will practice hand exercises~     without upper arm anesthesia and the other will exercise with anesthesia. All patients will~     perform two consecutive sessions of 30-minute pinch practice-forceful pinching of the thumb~     and index finger. Patients in the anesthesia group will have the anesthetic injected in the~     lower neck. Enough anesthetic will be administered to block motor and sensory function in the~     shoulder and upper arm, while maintaining as much function as possible in the forearm and~     hand.~      All patients will also have transcranial magnetic stimulation (TMS) testing. For this~     procedure, a very brief electrical current is passed through an insulated wire coil placed on~     the head, producing a magnetic pulse. The pulse travels through the scalp and skull and~     causes small electrical currents in the outer part of the brain. During the study, the~     patient will be asked to make movements, do simple tasks, or tense muscles, while the~     electrical activity of the muscles is recorded.~      Patients will have four sessions at 3-week intervals and three follow-up sessions at 3 weeks,~     9 weeks and 24 weeks after the testing. Follow-up evaluations will include pinch power~     testing, TMS, sensory function test and hand function measurement.~   "
273435|NCT00006413|"~     This study will investigate the safety and effectiveness of an experimental stem cell~     transplant procedure for treating mastocytosis-a disease of abnormal mast cell growth.~     Patients often feel faint, have skin problems, joint and bone pain, low blood counts and~     enlarged liver, spleen or lymph nodes. As yet, there is no cure for mastocytosis, and~     treatment is aimed at controlling symptoms.~      Stem cells are cells produced by the bone marrow that mature into the different blood~     components-white cells, red cells and platelets. Transplantation of allogeneic (donated) stem~     cells is a mainstay of therapy for some forms of leukemia. Patients first receive intensive~     chemotherapy and radiation to rid the body of cancer cells. This conditioning is followed~     by transplantation of donated stem cells to generate new, healthy bone marrow. In addition to~     producing the new bone marrow, the donated cells also fight any residual tumor cells that~     might have remained in the body. This is called a graft-versus-tumor effect. This study~     will examine whether a stem cell transplant from a healthy donor can similarly target and~     destroy mast cells in a graft-versus-mast cell effect. Also, to try to reduce the harmful~     side effects of chemotherapy and radiation, this study will use lower dose chemotherapy and~     no radiation.~      Patients with advanced mastocytosis between 10 and 80 years old may be eligible for this~     study. They will be~      tested for HLA type matching with a sibling and will undergo a medical history, physical~     examination and several tests to determine eligibility for the study.~      Participants will undergo apheresis to collect lymphocytes (a type of white blood cell) for~     immune function tests. In this procedure, blood is drawn through a needle in the arm, similar~     to donating a unit of blood. The lymphocytes are then separated and collected by a cell~     separator machine, and the rest of the blood is returned through a needle in the other arm.~     Patients will also have a central venous line (flexible plastic tube) placed in their upper~     chest leading to a vein. This line will remain in place throughout the transplant and~     recovery period and will be used to transfuse blood components, administer medicines, infuse~     the donated stem cells, and draw blood for tests. Patients will begin conditioning with~     cyclophosphamide, starting 7 days before the transplant, and fludarabine, starting 5 days~     before the transplant, to prevent rejection of the donated cells. From 1 to 3 days after the~     chemotherapy is completed, the stem cells will be transfused through the central venous line.~     Also, from 4 days before the transplantation until about 3 months after the procedure,~     patients will receive cyclosporine and mycophenolate mofetil-drugs that help prevent both~     rejection of the donated cells and attack by the donor cells on the patient's cells (called~     graft-versus-host disease).~      Patients will stay in the hospital about 20 to 30 days after the transplant. After discharge,~     they will continue to take antibiotics, cyclosporine and mycophenolate mofetil at home. If~     the mastocytosis progresses, cyclosporine and mycophenolate mofetil will be tapered over 4~     weeks. If the mastocytosis persists, patients may receive additional transfusions of donor~     lymphocytes to help kill the mast cells.~      Patients' progress will be followed weekly or twice weekly for 3 months, then at 6, 12, 18,~     24, 30, 36, 48 and 60 months after transplant, and then twice a year for various tests,~     treatments and examinations.~   "
273436|NCT00006411|"~     The Cornea Donor Study (CDS) was designed as a prospective cohort study with the following~     objectives:~      To determine whether the graft-failure rate over a 5-year follow-up period following corneal~     transplantation is the same when using corneal tissue from donors older than 65 years of age~     compared with tissue from younger donors.~      To assess the relationship between donor/recipient ABO blood type compatibility and graft~     failure due to rejection.~      To assess corneal endothelial cell density as an indicator of the health of the cornea and as~     a alternate outcome measure (in an optional Specular Microscopy Ancillary Study).~   "
273437|NCT00006409|"~     To test the effectiveness of a multicomponent school-based and community-linked intervention~     in preventing the decline in physical activity levels and cardiovascular fitness in girls in~     grades 6-8.~   "
273438|NCT00006408|"~     To investigate the relationship between life-stress factors associated with socioeconomic~     conditions and hypertension.~   "
273439|NCT00006407|"~     To investigate the relationship between endogenous estrogen and androgen levels and risk of~     coronary heart disease among postmenopausal women in the Women's Health~     Initiative-Observational Study (WHI-OS).~   "
273440|NCT00006406|"~     To analyze the relationship of dietary variables to urinary excretion of amino acids and the~     relationships of specific urinary amino acids to blood pressure.~   "
273441|NCT00006405|"~     To determine whether a one year afternoon exercise program will reduce adiposity in African~     American girls, ages 8 to 10.~   "
273442|NCT00006404|"~     To evaluate the role of maternal diet and birth weight in the etiology of childhood asthma~     and other allergic disorders.~   "
273443|NCT00006403|"~     To determine the relation between cardiovascular disease risk factors and systemic markers of~     vascular inflammation in the Framingham Study cohort.~   "
273444|NCT00006402|"~     To determine the influences of diet and physical activity (PA) on total body fatness and~     regional fat distribution and the relationship of these to risk factors of cardiovascular~     disease during adolescence.~   "
273445|NCT00006401|"~     To determine whether or not inhaled nitric oxide (iNO) safely decreases the incidence of~     chronic lung disease (CLD) in premature infants.~   "
273446|NCT00006400|"~     The purpose of this study is to determine if hydroxyurea therapy is effective in the~     prevention of chronic end organ damage in pediatric patients with sickle cell anemia.~   "
273447|NCT00006398|"~     The purpose of this study is to learn whether timolol is useful in preventing or delaying the~     appearance of gastroesophageal varices, a complication that may develop in the future as a~     consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing~     through the liver. This leads to an increased pressure in the portal vein (the vein that~     takes blood to your liver). High portal pressure is responsible for the appearance of~     complications of chronic liver disease such as varices and variceal bleeding (bleeding from~     veins in your esophagus). Timolol belongs to a group of medications called beta-blockers.~     Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker~     pills are useful in preventing bleeding from varices in patients who already have varices. A~     more desirable effect would be if these pills could prevent not only bleeding from varices~     but the appearance of varices (and therefore of bleeding).~   "
273448|NCT00006394|"~     OBJECTIVES: I. Compare whether the bone tissue in the spine and hip improves in patients with~     adult onset growth hormone deficiency treated with growth hormone (GH) vs placebo.~      II. Determine whether the blood samples of these patients show evidence of beneficial bone~     effects after treatment with GH.~      III. Compare the quality of life of these patients treated with these 2 regimens.~      IV. Determine the side effects of GH in these patients.~   "
273449|NCT00006393|"~     OBJECTIVES: I. Determine whether defects in fibrillin-1 cellular processing are present in~     the tsk1 mouse model that carries a known FBN1 gene rearrangement and in a population of~     Choctaw Native American patients with systemic sclerosis who have a strong genetic~     predisposition to the disease.~      II. Determine the ultrastructural features of fibrillin-1 in these patients. III. Screen the~     FBN1 gene for mutations beginning at the regions homologous to the tsk1 duplication and~     latent transforming growth factor binding proteins in these patients and in an unaffected~     Choctaw control group.~      IV. Determine the correlation between fibrillin-1 abnormalities and clinical presentation,~     autoantibodies, and ethnicity.~   "
273543|NCT00006157|"~     The primary purpose for this study is to compare clinical treatments for patients with~     functional bowel disorders (irritable bowel syndrome, abdominal pain, painful constipation)~     in women. We also plan to: 1) determine what clinical features (medical or psychological)~     determine which patients will improve to these treatments, and 2) understand if there are any~     physiological features that relate to improvement in symptoms and response to the treatments.~      We will compare a psychological treatment (cognitive-behavioral therapy - CBT) with~     education/attention placebo, and an antidepressant drug (desipramine) with a pill placebo.~     This is the first large-scale study designed to determine the therapeutic effects of these~     methods, and to also determine interactions among physiologic measures, psychologic and~     sociodemographic factors, severity of symptoms, and therapeutic improvement including quality~     of life.~   "
273450|NCT00006337|"~     This study will evaluate the effects of an experimental drug called KW-6002 on Parkinson's~     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of~     long-term treatment with levodopa. This drug blocks the action of the neurotransmitter~     adenosine, thought to be involved in producing Parkinson's symptoms.~      Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 80~     years of age may be eligible for this 7-week study. Participants will have a complete medical~     history and physical examination, including blood tests and an electrocardiogram, and~     possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray.~      Patients enrolled in the study will, if possible, stop taking all antiparkinsonian~     medications except levodopa (Sinemet) for one month before the study begins and throughout~     its duration. For the first 1 to 3 days, patients will be admitted to the NIH Clinical center~     to undergo a levodopa dose-finding procedure. For this study, patients will stop taking~     Sinemet and instead will have levodopa infused through a vein for up to 8 hours/day. During~     the infusions, the drug dose will be increased slowly until either 1) parkinsonian symptoms~     improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached.~     Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than~     what is needed to relieve symptoms, and 2) one that relieves symptoms but may produce~     dyskinesias. This procedure will be repeated at the end of weeks 2, 4 and 6 of the study.~      When the patient's optimal dose is determined treatment will begin. Patients will take~     tablets or capsules containing KW-6002 or placebo (a look-alike pill with no active~     ingredient) once a day for 2 weeks, in addition to their regular Sinemet. All participants~     will receive placebo at least 2 weeks during the study; some patients will receive only~     placebo throughout the entire 7 weeks. At the end of weeks 1, 3 and 5, patients will be~     evaluated with a brief physical examination, routine blood and urine tests, and assessment of~     any adverse effects.~      Throughout the study, parkinsonian symptoms and dyskinesias will be evaluated and blood~     samples will be drawn periodically to measure drug levels.~   "
273451|NCT00006336|"~     This study will examine the effectiveness of Braille reading as a sensory training program~     for improving symptoms of focal (localized) dystonia, a movement disorder caused by sustained~     muscle contractions. Musicians, writers, typists, athletes and others whose work involves~     frequent repetitive movements may develop focal dystonia of the hand. Dystonia patients have~     an impaired sense of touch, and it is thought that symptoms may improve with sensory tactile~     (touch) training.~      Patients with task-specific dystonia and healthy normal volunteers may be eligible for this~     8-week study. Patients will undergo evaluation of their dystonia and a complete neurologic~     examination. Healthy volunteers will have a complete physical examination.~      On the first day of the study, after 4 weeks and after 8 weeks, all participants will have a~     gap detection test for sensory perception testing. The test uses eight plastic devices called~     JVP-Domes with ridges of different widths on the surface. The subject's arm and hand are held~     in palm-up position and the right index finger is tested for about 1 second 20 times with~     each dome. The subject is asked to report whether the direction of the dome is vertical or~     horizontal. The test takes about 30 minutes. Patients with dystonia will also have a their~     symptoms evaluated at these visits. The evaluation involves completing a written~     questionnaire and writing a paragraph.~      All participants will be trained in Braille reading at NIH. Sessions will be given every day~     the first week, twice a week the second and third weeks, and once a week the following weeks.~   "
273452|NCT00006335|"~     The purpose of this study is to learn what factors influence adolescent girls' decisions~     regarding testing for carrier status of X-Linked Severe Combined Immunodeficiency (XSCID). It~     will provide information about how healthy relatives feel about whether they could be XSCID~     carriers, whether carrier testing should be pursued, and, if so, at what age. Commonly known~     as Bubble Boy Disease, XSCID is a rare, life-threatening immune system disorder that~     affects only males, but females who carry the gene mutation can pass the disease to their~     male children.~      Adolescent girls 13 to 17 years old who have a relative with XSCID and are known to be at~     risk for being carriers are eligible for this study.~      Participants will receive genetic counseling to help them decide if they want to be tested~     for the XSCID gene. Those who elect to be tested will provide a DNA sample from either a~     blood draw or brushing taken from inside the mouth. They will receive the test results from~     the same genetic counselor they spoke with before the testing.~      All participants will also talk with a psychologist over the phone once a year for 3 years to~     answer questions about how they are feeling and what they know about XSCID. They will be~     asked to discuss their decision and feelings about carrier testing.~   "
273453|NCT00006334|"~     This study examines the clinical and genetic factors related to Turner syndrome, a disorder~     of the sex chromosomes. Humans usually have 23 pairs of chromosomes-thin strands of DNA-in~     the nucleus of every cell, which contain genes that determine our hereditary makeup. One pair~     of chromosomes is the sex chromosomes, designated X and Y. Females usually have two X~     chromosomes; however, patients with Turner syndrome have only a single X chromosome or one~     normal and one defective X or Y chromosome. This abnormality can cause medical problems such~     as short stature, premature ovarian failure and heart or kidney defects. Individuals with~     Turner syndrome have an increased risk of thyroid disorders, high blood pressure, diabetes~     mellitus, abnormal liver function, hearing loss and osteoporosis. This study will try to~     identify the genes responsible for the specific medical problems associated with the~     disorder.~      Females 10 years of age and older with X chromosome defects may be eligible for this 3- to 5-~     day inpatient study at the National Institutes of Health Clinical Center in Bethesda,~     Maryland. Participants will have a physical examination, body measurements (height, weight,~     hip and waist) and blood drawn for clinical and research purposes.~      Participants will have a comprehensive cardiovascular evaluation, including an~     electrocardiogram (ECG), 24 hour blood pressure monitoring, magnetic resonance imaging (MRI)~     of the heart and aorta, ultrasound imaging of the heart (cardiac echo) and expert~     consultation with the NIH Cardiology Service. Women 35 years of age and older may have a~     computerized tomography (CT) scan of the coronary arteries to investigate possible blockage~     of the heart blood supply.~      Risk for diabetes is investigated by studies of the body fat content and an oral glucose~     tolerance test. The risk for coronary artery disease is assessed by measurement of~     cholesterol and other known risk factors in the blood. Thyroid function and presence of~     antibodies to the thyroid gland are also evaluated by blood tests.~      Liver function is tested by measurement of products of liver metabolism in the blood and by a~     liver ultrasound. Ovary function is investigated by blood tests of estrogen and FSH levels~     and pelvic untrasound which visualizes the uterus.~      Bone structure and strength are evaluated by routine X-rays of the wrists and spine, and DEXA~     scan (a type of X-ray study that measures body fat, muscle and bone thickness). Adults will~     also have bone density of the spine and abdominal fat content measured by CT, which is more~     accurate than DEXA. Vitamin D levels are measured in blood tests.These are state of the art~     diagnostic tests which may uncover unsuspected anatomic problems such as abnormalities of the~     aorta or aortic valve which have serious clinical implications and would indicate the need~     for close medical follow-up, as well as uncover potential risk for development of diabetes or~     osteoporosis in the future, which would also indicate the need for changes in lifestyle or~     medical management. Study participants are invited to return for re-evaluation at 1-3 year~     intervals. A major goal of follow-up visits is to determine whether there is any enlargement~     of aortic diameter or impairment of cardiac function over time.~      Some patients may be asked to undergo a skin biopsy (removal of a small sample of skin~     tissue) to obtain more information about genetic make-up of cells. Parents of patients may be~     contacted (with the patient's permission) to provide a blood or saliva sample for genetic~     study to help understand how and why certain traits of Turner syndrome are expressed.~   "
273454|NCT00006333|"~     This research protocol will recruit patients with arthritis and related conditions for the~     purpose of screening patients for treatment protocols, and evaluating the natural history of~     arthritis and related conditions. Patients will be evaluated clinically, radiographically and~     serologically, and standardized data will be uniformly collected on all patients. Additional~     imaging using sensitive MRI methods will be obtained in some patients. The collected blood~     and tissue will be utilized for laboratory studies to continue research on the pathogenic~     mechanisms of rheumatoid arthritis and related autoimmune joint diseases. Data from the~     history and physical examination as well as several disability questionnaires in the adult~     and pediatric population will be used to phenotypically characterize these patients and~     assess outcome and functional status. Any medical care recommended or provided to the~     patients will be consistent with routine standards of practice and provided in consultation~     with the patient's referring physician.~   "
273455|NCT00006332|"~     Hepatocellular carcinoma (HCC) is a deadly tumor for which the incidence is increasing in the~     United States, primarily due to prevalence of hepatitis C infection. An important aspect of~     the development of HCC is that it occurs in patients who have underlying cirrhosis of the~     liver, thereby limiting the therapeutic options. There is potential curative treatment for~     these patients, such as resection of the tumor lesion and liver transplantation, but these~     treatments are feasible in a small percent of patients only. Furthermore, the majority of the~     patients with HCC are also not candidates for palliative treatments such as percutaneous~     ablation of the tumor, chemotherapy or radiation. Additionally, it has been shown that these~     palliative treatment modalities do not alter survival, and are associated with significant~     risks. Therefore, there are no treatment options for most patients with HCC. A new theory has~     emerged in the fight against cancer through inhibition of angiogenesis (development of new~     blood vessels). The hypothesis being that if there is no blood supply feeding the tumor~     cells cannot divide or survive. One such approach, pioneered in this institution by Drs.~     George Brewer and Sofia Merajver, is the anticopper approach using the medication~     tetrathiomolybdate (TM). By creating a mild copper deficiency state, several pathways~     required for angiogenesis are inhibited. They performed a Phase I trial in which patients~     with metastatic cancer were treated with TM resulting in decrease tumor vascularity. TM had~     excellent safety profile in this patient population. HCC is well known to be a hypervascular~     tumor. An antiangiogenesis approach might provide a novel treatment for this HCC. This is a~     pilot study of 10 patients with HCC who are not candidates for curative surgical therapy with~     resection or liver transplantation, nor for ablative techniques. Patients seen in the General~     Liver clinic and Liver Transplant clinic who have an overall good performance status, with an~     expected survival of more than 6 months will be enrolled. After an initial evaluation, they~     will be given 120 mg/day of TM in divided doses for one year. The size and vascularity of the~     tumor will be evaluated by magnetic resonance imaging (MRI). The primary outcome of this~     study is to prevent tumor progression.~   "
273544|NCT00006151|"~     The purpose of this study is to combine a smoke ending aid with behavioral treatment.~   "
273457|NCT00006330|"~     Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American~     herbal medicine practice. Some of its cardiac uses include the treatment of high and low~     blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used~     as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To~     date, little information is known about the effect of hawthorn when taken with other drugs~     and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is~     to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects~     will be recruited by advertisement. The design of the study will include a 10-day and a~     three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special~     extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover.~     There will be a three-week washout period in between treatment phases. On day 10 (phase I)~     and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic~     analysis. The plasma samples will be measured for digoxin concentration. Additionally, the~     subjects will be assessed for any clinical toxicities or adverse events. The significance of~     this study is to provide the clinician with information regarding the safe use of digoxin in~     combination with the herbal supplement, hawthorn.~   "
273458|NCT00006329|"~     Parathyroid glands are small endocrine glands that secrete a hormone which controls blood~     calcium levels. Primary hyperparathyroidism (PH) is a common disorder whereby one or more of~     these glands may enlarge and overproduce their hormone. Subsequently, the elevated blood~     calcium can cause many other symptoms and problems. The standard treatment is surgical~     removal of the gland(s) causing the disorder. The standard safe and effective operation has~     been the bilateral open parathyroid exploration (BOPE). A newer procedure using a radioactive~     compound that concentrates in the parathyroid glands allows a more limited operation to find~     and remove the causative gland [Minimally-Invasive Radioguided Parathyroidectomy (MIRP)]. The~     radiation exposure is minimal and safe. Although the operation may prove to be less~     expensive, it is not certain whether it is as effective or as safe as BOPE. This study serves~     to directly compare the costs, the effectiveness, and the safety associated with each type of~     operation. All patients (adolescents and older) with PH are candidates to participate. The~     participants will be randomly assigned to the MIRP group or the BOPE group independently of~     patient or physician preferences. MIRP patients will undergo a sestamibi nuclear medicine~     scan to attempt to localize the specific parathyroid gland causing the hyperparathyroidism~     and subsequently a limited operation under local anesthesia to remove the single gland.~     Parathyroid hormone levels will be measured during the operation to ensure that the patient~     has been cured. If not, the standard BOPE procedure will be completed. The total cost of the~     care will be tracked for each group. Careful testing for complications such as vocal cord~     dysfunction will be done. General Health status and pain levels will be measured before and~     after each operation. Patient satisfaction with the operation and care will also be assessed.~   "
273459|NCT00006328|"~     This study is intended to help doctors learn about the relationships between specific genetic~     makeup (gene markers) and the development of chronic rejection. This study is being done to~     see if there is a relationship between genetic patterns and the development of Chronic~     Allograft Nephropathy (CAN). Medical scientists also hope to learn more about how genetic~     differences between people determine their response to a drug or a disease by storing a small~     blood sample in a special bank. This sample may be tested at some point in the future in an~     attempt to better understand the factors that may influence rejection, transplantation~     outcomes and transplant success rates.~   "
273460|NCT00006323|"~     To identify physiological and clinical measures of obstructive sleep-disordered breathing~     that are associated with increased morbidity in children.~   "
273461|NCT00006322|"~     To investigate the relationship of birth weight and childhood blood pressure.~   "
273462|NCT00006321|"~     To assess associations between behavioral/neuropsychological measures and various measures of~     sleep disordered breathing (SDB) and to determine the prevalence of SDB in children with~     Attention Deficit Hyperactivity Disorder (ADHD).~   "
273463|NCT00006320|"~     This study will determine if blood levels of anti-HIV drugs in pregnant women change at~     different stages of pregnancy and if these changes require dosage adjustments in order to~     maintain adequate drug levels during pregnancy. Anti-HIV medications are recommended for~     HIV-infected women during pregnancy not only to treat their infection, but also to reduce the~     chance of passing the virus to the baby during pregnancy. Changes in the body that occur~     during pregnancy may affect how the body uses and eliminates these drugs, reducing their~     levels during pregnancy.~      Pregnant women 18 years of age or older who are infected with HIV may be eligible for this~     study. Candidates will have a medical history and physical examination, pregnancy test and~     blood tests.~      Participants will come to the NIH Clinical Center once every 6 to 12 weeks until around their~     34th week (8 months) of pregnancy and then again at least 1 month after the birth of the baby~     to have blood drawn. A catheter (thin plastic tube) will be placed in a vein to avoid~     multiple needle sticks for blood sampling during the day. The first sample will be collected~     before the patient takes the morning doses of anti-HIV medicines and additional samples will~     be drawn at 1, 2, 4, 8 and 12 hours after taking the medication. A urine sample will also be~     collected at each visit.~   "
273464|NCT00006319|"~     This study will try to identify mutations in the genes responsible for primary~     immunodeficiency disorders (inherited diseases of the immune system) and evaluate the course~     of these diseases in patients over time to learn more about the medical problems they cause.~     The immune system is composed of various cells (e.g., T and B cells and phagocytes) and other~     substances (complement system) that protect the body from infections and cancer.~     Abnormalities in the gene(s) responsible for the function of these components can lead to~     serious infections and other immune problems.~      Patients with Wiskott-Aldrich syndrome, adenosine deaminase (ADA) deficiency. Participants~     will undergo a medical and family history, physical examination, and additional procedures~     and tests that may include the following:~        1. Blood tests for: routine laboratory studies (i.e. cell counts, enzyme levels,~          electrolytes, etc.); HIV testing; immune response to various substances; genetic~          testing; and establishment of cell lines to maintain a supply of cells for continued~          study~        2. Urine and saliva tests for biochemical studies~        3. Skin tests to assess response to antigens such as the viruses and bacteria responsible~          for tetanus, candida, tuberculosis, diphtheria, chicken pox, and other diseases.~        4. Skin and lymph node biopsies for tissue and DNA studies~        5. Chest X-ray, CT scans, or both to look for cancer or various infections.~        6. Pulmonary function test to assess lung capacity and a breath test to test for H. pylori~          infection.~        7. Dental, skin and eye examinations.~        8. Treatment with intravenous immunoglobulins or antibodies to prevent infections.~        9. Apheresis for collecting white blood cells to study cell function. In this procedure,~          whole blood is collected through a needle placed in an arm vein. The blood circulates~          through a machine that separates it into its components. The white cells are then~          removed, and the red cells, platelets and plasma are returned to the body, either~          through the same needle or through a second needle placed in the other arm.~       10. Bone marrow sampling to study the disease. A small amount of marrow from the hipbone is~          drawn (aspirated) through a needle. The procedure can be done under local anesthesia or~          light sedation.~       11. Placental and umbilical cord blood studies, if cord blood is available, to study stem~          cells (cells that form blood cells).~      Information gained from this study may provide a better understanding of primary~     immunodeficiencies, leading to better diagnosis and treatment. In addition, study~     participants may receive medical and genetic counseling and may be found eligible for other~     NIH studies on these diseases.~   "
273667|NCT00005720|"~     To develop a scientifically valid and ethnically approved, lay-led smoking cessation~     intervention for Southeast Asian men and women, i-e., those from Cambodia, Laos, and Vietnam.~   "
273465|NCT00006318|"~     This study will use magnetic resonance imaging (MRI) to examine the role of prostaglandins-a~     type of fatty acid with hormone-like actions-in the regulation of brain blood flow. The~     results will provide information on how to better use this technique to study brain function,~     which, in turn, may lead to a better understanding of certain illnesses and more effective~     treatments.~      Healthy normal volunteers 18 years of age and older may be eligible for this study.~     Participants will fill out a health questionnaire and undergo a history, physical examination~     and MRI studies. MRI is a diagnostic tool that uses a strong magnetic field and radio waves~     instead of X-rays to show structural and chemical changes in tissues. During the scanning,~     the subject lies on a table in a narrow cylinder containing a magnetic field. An intercom~     system allows the subject to speak with the staff member performing the study at all times~     during the procedure. Four separate studies will be done-two carbon dioxide inhalation~     studies and two functional activation studies-as follows:~      Carbon dioxide inhalation (indomethacin): This study is done in two parts. In both parts, an~     MRI brain scan is done. During the scan, the subject inhales an air mixture containing 6%~     carbon dioxide through a facemask or mouthpiece. Blood pressure and heart rate are monitored~     during inhalation of the mixture. For the second part of the study, indomethacin-a~     non-steroidal anti-inflammatory drug-is injected through a catheter (thin flexible tube) in~     an arm vein. Indomethacin inhibits prostaglandin production. Total scan time averages between~     45 and 90 minutes, with a maximum of 2 hours.~      Carbon dioxide inhalation (rofecoxib and celecoxib): This study is identical to the one~     above, except either rofecoxib or celecoxib is given instead of indomethacin. Both of these~     drugs are also non-steroidal anti-inflammatory drugs that inhibit prostaglandin production.~     Unlike indomethacin, rofecoxib and celecoxib are given orally instead of through a vein, so,~     to allow time for the drug to be absorbed, the second scan is delayed for 2 hours.~      Functional activation (indomethacin): This study is done in two parts. In both parts, a MRI~     brain scan is done. During the study, the subject performs a simple motor task, such as~     finger tapping. For the second part of the study, indomethacin is injected through a catheter~     in an arm vein.~      Functional activation (rofecoxib and celecoxib): This study is identical to the indomethacin~     functional activation study, except either rofecoxib or celecoxib is given instead of~     indomethacin. Because they are given orally instead of through a vein, the second scan is~     delayed 2 hours to allow time for the drug to be absorbed.~   "
273466|NCT00006315|"~     To examine the dose-response of exercise on long-term weight loss in overweight adult women.~   "
273467|NCT00006314|"~     To investigate the relationship between HCMV and bone marrow progenitor cells to understand~     whether HCMV is latent in CD34 + bone marrow progenitors and the mechanism by which the virus~     remains in a latent state.~   "
273468|NCT00006313|"~     To conduct extended analysis of the Postmenopausal Estrogen/Progestins Intervention PEPI~     trial database to address questions related to cardiovascular disease risk factor response~     and the possible determinants of this response.~   "
273469|NCT00006312|"~     To examine the cost effectiveness of hereditary hemochromatosis (HH) screening in primary~     care.~   "
273470|NCT00006311|"~     To examine the role of reduced vagal control of heart rate in the increased risk of cardiac~     mortality associated with anxiety in a population with established coronary artery disease~     (CAD). A second objective is to determine whether the effects of anxiety are independent of~     the effects of depression.~   "
273471|NCT00006310|"~     To determine the seroprevalence of Kaposi's sarcoma-associated herpesvirus (KSHV/HHV8) in~     blood donors from Texas. Also to examine the donors' demographic characteristics and to~     characterize the KSHV using polymerase chain reaction.~   "
273472|NCT00006309|"~     To quantify the role of dietary factors in the etiology of coronary heart disease by pooling~     data from 10 major prospective studies on diet and coronary heart disease.~   "
273473|NCT00006308|"~     To investigate cardiovascular events among individuals with low sodium intake or large weight~     changes in a prospective observational follow-up of subjects from the Trials of Hypertension~     Prevention (TOHP) study.~   "
273474|NCT00006307|"~     To investigate the relationship between obesity, body mass index (BMI) rebound, body~     composition changes, associated factors (e.g., diet, physical activity), and cardiovascular~     risk factor status in a longitudinal study of young children, age three at the beginning of~     the study.~   "
273475|NCT00006306|"~     To determine the effects of chronic ozone exposure on lung function in young men and women.~   "
273476|NCT00006305|"~     The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients~     being assigned at random to initial elective revascularization with aggressive medical~     therapy or aggressive medical therapy alone with equal probability, and simultaneously being~     assigned at random to an insulin providing or insulin sensitizing strategy of glycemic~     control (with a target value for HbA1c of less than 7.0% for all patients).~      SPECIFIC AIMS~      A. Primary Aim~      The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment~     efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the~     setting of uniform glycemic control and intensive management of all other risk factors~     including dyslipidemia, hypertension, smoking, and obesity:~        1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization~          of choice (surgical or catheter-based) combined with aggressive medical therapy results~          in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;~        2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a~          strategy of hyperglycemia management directed at insulin sensitization results in lower~          5-year mortality compared to a strategy of insulin provision.~      B. Secondary Aims~      The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial~     infarction or stroke combined endpoint event rate between the revascularization versus~     medical therapy groups and between the insulin sensitization versus insulin provision groups;~     b) comparing rates of myocardial infarction, other ischemic events, angina and quality of~     life associated with each revascularization and hyperglycemia management strategy; c)~     evaluating the relative economic costs associated with the trial treatment strategies, d)~     exploring the effect of glycemic control strategy on the progression and mechanism of~     vasculopathy including changes in PAI-1 gene expression.~   "
273477|NCT00006301|"~     This study will identify and characterize immune factors involved in hepatitis C infection~     and elimination of the virus. Individual responses to hepatitis C infection vary; some people~     are able to eliminate the virus, whereas others remain chronically infected. This study may~     identify factors important in preventing infection that may be of help in developing a~     vaccine or more effective treatments.~      People over 18 years old who have been exposed to hepatitis C virus may participate in this~     study. Subjects will be recruited from the National Institutes of Health, Inova Fairfax~     Hospital, Occupational Medical Services-IDP P.C., Washington Hospital Center and Holy Cross~     Hospital, all in the Washington, D.C. metropolitan area. Individual patients from other~     centers will also be recruited on a case by case basis.~      Participants will have 40 to 60 cc (1 to 2 ounces) of blood drawn at seven intervals. The~     first collection will be as soon as possible after exposure to hepatitis C virus and then~     again at 2, 4, 6, 12, 24, and 48 weeks after exposure. The white blood cells will be studied~     for their response to the virus, and markers for infection will be followed. If infection~     develops, additional samples of blood may be requested, and patients will be offered~     evaluation for treatment. Test results will be kept confidential and will not be entered into~     any medical records.~   "
273478|NCT00006300|"~     The purposes of this study are threefold: 1) to evaluate the prevalence and risks of oral~     complications in patients with aplastic anemia; 2) to evaluate if oral problems in these~     patients can predict their response to treatment; and 3) to review complications of dental~     treatment in these patients in order to establish treatment guidelines.~      This study will be performed through a review of medical charts of 79 patients with aplastic~     anemia and 67 patients with schizophrenia who were treated at the National Institutes of~     Health Dental Clinic between 1993 and 1999. The schizophrenia patients will serve as a~     control population.~      Demographic, clinical and radiographic information will be collected for all patients.~     Additional data collected only for aplastic anemia patients will include medical therapy,~     disease duration, blood cell counts, oral problems that developed during treatment and~     treatment response.~   "
273479|NCT00006299|"~     This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on~     relieving pain after oral surgery. It is also designed to assess the drug's selective~     inhibition of a chemical called cyclooxygenase-2 and not its closely related form,~     cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side~     effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs.~      Healthy volunteers who require removal of their third molars are eligible for this study.~     Participants will have oral surgery for tooth extraction after receiving a local anesthetic~     (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening~     before and 1 hour before surgery, patients will be given a dose of either the standard~     anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill~     with no active ingredient). After surgery, a small piece of tubing will be placed in each~     extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected~     from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in~     the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete~     pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol~     3), if needed, for pain. The tubing then will be removed and the patient discharged with~     standard pain medication.~   "
273480|NCT00006297|"~     To investigate whether traditional risk factors and novel risk factors predict higher risk of~     atherosclerotic cardiovascular disease (ASCVD) in a prospective study of incident dialysis~     patients.~   "
273481|NCT00006296|"~     To assess in four large Chicago population cohorts whether young adult and middle-aged risk~     factor status has an impact not only on average annual Medicare costs, but also on cumulative~     and lifetime Medicare costs, to ages 70, 75, 80, >80, including to death, and during the last~     one to two years of life.~   "
273482|NCT00006295|"~     To study the genetic cause of low HDL-C, a risk factor for premature atherosclerotic vascular~     disease in patients with normal total cholesterol. The focus is primarily on the~     identification of a single mutation, as has been demonstrated in one family.~   "
273483|NCT00006294|"~     To examine whether the association between selected hypertensive genes and combined fatal~     coronary heart disease and nonfatal myocardial infarction in high-risk hypertensives is~     modified by the type of antihypertensive treatment, leading to differential risks of coronary~     heart disease.~   "
273484|NCT00006292|"~     This study will test whether the drug combination of methotrexate and infliximab~     (anti-TNF-alpha antibody) is more effective than methotrexate alone for treating rheumatoid~     arthritis early in the disease. (The Food and Drug Administration has approved both treatment~     regimens for patients with long-standing rheumatoid arthritis.) The study will also evaluate~     how effectively magnetic resonance imaging (MRI) can detect differences in the development of~     bone damage in the two treatment groups by as early as 6 months.~      Patients 18 years of age and older who have had rheumatoid arthritis for less than 2 years~     and who have four or more affected joints may be eligible for this 1-year study. Patients~     must have received methotrexate treatment in the past without complete success, and must not~     have been treated previously with Anti-Thymocyte therapy.~      All participants will receive 20 Mg./week of methotrexate. In addition, patients will be~     randomly assigned to receive a monthly infusion of infliximab or placebo (a fluid that~     contains no active drug). After 6 months, all patients will receive active infliximab for the~     remaining half year of the study. Patients will also receive folic acid (1mg/day), Vitamin D~     (400 IU/day), and calcium supplements. They may continue to take prednisone (no more than 10~     Mg./day) and non-steroidal anti-inflammatory drugs (NSAIDS). Medication dosages will be~     adjusted as needed if pain and joint swelling worsen. Over the course of the study, patients~     will come to NIH for 15 visits and undergo the following tests and procedures:~        1. Joint examination-at every visit.~        2. Drug side effects evaluation-at every visit during the study and after the study at 24~          and 36 months by questionnaires to be filled out and returned.~        3. Hand and feet X-rays at the first visit, at 6 months and at 12 months.~        4. MRIs of the wrist to examine damage in the bone and synovial tissue (tissue lining the~          joint)-before treatment begins and at weeks 15, 27 and 54. For this study, the patient~          lies still in a narrow cylinder (the scanner) with a strong magnetic field. A contrast~          material (gadolinium) is injected into the blood to enhance the images of the synovium.~          The MRI takes about 45 minutes.~        5. DEXA scans (dual emission X-ray absorptiometry) of the lower spine, one hip and one~          wrist to measure bone density and assess bone loss-before treatment begins and at weeks~          27 and 54. This X-ray test takes about 5 to 10 minutes.~        6. CTs (computed tomography) of one hand to assess joint damage in the wrist-before~          treatment begins and at weeks 27 and 54. Only half the patients in the study will have~          this X-ray study, which produces 3-dimensional images of the hand. It will be done to~          compare the location, size and change of damage in the wrist seen on CT with the~          information obtained on MRI. The procedure takes about 5 to 10 minutes to complete.~        7. Blood tests-at every visit to evaluate treatment response and side effects.~   "
273485|NCT00006289|"~     This study will examine the effectiveness of the drug neurotropin in treating chronic pain~     after injury to a limb or a large nerve.~      Two groups of patients will participate in this study: patients with complex regional pain~     syndrome type 1, or CRPS-I (also called reflex sympathetic dystrophy) and patients with~     complex regional pain syndrome type 2, or CRPS-II. CRPS-I is pain that develops after~     relatively minor injury to an arm or leg, but lasts much longer and is much more severe than~     would normally be expected. CRPS-II is pain resulting from injury to a large nerve.~     Candidates will have a history and physical examination, blood tests, and electrocardiogram.~     Participants will undergo the following tests and procedures:~      Patients with CRPS I and II will receive an individualized regimen of physical therapy and~     standard treatment to control their pain. In addition, they will receive neurotropin or~     placebo tablets for 5 weeks, then no trial medicine for at least 1 week, and then the other~     trial drug for the next 5 weeks. That is, patients who took placebo the first 5 weeks will~     take neurotropin the second 5 weeks and vice versa. Neither the patients nor the doctors will~     know who received which drug during the two intervals until the study is over. Patients will~     complete questionnaires about their pain, quality of life, and ability to perform daily~     living activities. They will have various tests to measure pain (such as sensitivity to heat~     and cold, to an electric current, to a mild pin prick, etc.); to provide information about~     changes in their condition (such as tests of range of motion of joints and limb size); to~     measure blood circulation and sweating in the arm or leg (such as measurements of blood flow~     to the limb, skin temperature, and sweat production), and other procedures.~   "
273541|NCT00006159|"~     The purpose of this project is to determine whether a diabetes lifestyle program will improve~     the lives of Native American people living with diabetes. We recruited Native American people~     living in 8 Pueblo communities served by 3 Indian Health Service clinics. Forty percent of~     people living with diabetes in those communities participated in an interview and had height,~     weight, blood pressure and hemoglobin A1c measured at the beginning. Then they received a~     lifestyle program in either groups or one-on-one, or another group which got the intervention~     after one year (comparison group). The program was developed using input from community~     members, tribal leaders, and clinic staff, and was taught by community members in or near the~     participating communities. After each session, participants were asked for feedback about the~     curriculum. After the program ended, the interview and clinical measures were repeated.~     Feedback to tribal leaders and clinical staff is ongoing.~   "
273487|NCT00006286|"~     TADS is designed to compare the effectiveness of established treatments for teenagers~     suffering from major depressive disorder (MDD). The treatments are: psychotherapy (talking~     therapy); medication; and the combination of psychotherapy and medication. Altogether, 432~     teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in~     the United States.~      The TADS design will provide answers to the following questions: What is the long-term~     effectiveness of medication treatment of teenagers who have major depression? What is the~     long-term effectiveness of a specific psychotherapy (talking therapy) in the treatment of~     teenagers who have major depression? How does medication treatment compare with psychotherapy~     in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the~     cost-effectiveness of medication, psychotherapy and combined treatments?~      The medication being used in this study is called fluoxetine. Fluoxetine is also known as~     Prozac. Research has shown that medications like Prozac help depression in young persons.~     Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent~     (ages 7 to 17 years) depression.~      The psychotherapy or talking therapy being used in this study is called Cognitive~     Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his~     or her family member (e.g., parent) new skills to cope better with depression. Specific~     topics include education about depression and the causes of depression, setting goals,~     monitoring mood, increasing pleasant activities, social problem-solving, correcting negative~     thinking, negotiation, compromise and assertiveness. CBT sessions may also help with~     resolving disagreements as they affect families.~   "
273488|NCT00006278|"~     This study is designed to provide information about the cause of two unusual types of~     Cushing's syndrome and to evaluate quality of life before and after cure of the disease. In~     Cushing's syndrome, the adrenal glands produce too much of the hormone cortisol. This often~     causes weight gain, skin changes (bruising and stretch marks), and mood changes such as~     irritability, easy crying and depression. Adrenocorticotrophic hormone (ACTH) normally~     regulates cortisol production; when cortisol is low, ACTH rises, stimulating the adrenals to~     produce more cortisol, and when cortisol is high, ACTH levels fall. In two forms of Cushing's~     syndrome, however, the adrenal glands produce cortisol even when ACTH is low.~      Patients 18 years of age and older with Cushing's syndrome not related to ACTH production may~     participate in this study. Candidates will be have a history and physical examination,~     electrocardiogram, urine, blood and saliva tests, and a computerized tomography (CT) scan of~     one or both adrenal glands. They will fill out questionnaires on their disease symptoms,~     quality of life, and on basic information about themselves, such as marital status, education~     level, place of residence, etc. Finally, they will have a corticotropin-releasing hormone~     (CRH) test to confirm that they have the form of Cushing's syndrome under study in this~     protocol. This test involves collecting blood samples at intervals before and after~     administration of sheep CRH to measure cortisol and ACTH levels.~      Participants will undergo 3 to 7 days of testing to determine if their cortisol level rises~     after taking certain medicines or eating certain foods. These foods and medicines, chosen to~     mimic or stimulate substances already in the body, are: glucagon, ACTH,~     gonadotropin-releasing hormone, vasopressin, thyrotropin-releasing hormone, and a mixed meal~     consisting of a protein, carbohydrate and fat (usually chicken breast and a milkshake-like~     drink). Blood will be collected at intervals before and after taking the food or medicine to~     measure cortisol blood levels. Blood will also be collected while the patient is in a~     standing position and while lying in bed, because changes in posture can cause substances in~     the body to increase or decrease. Depending on the individual's response to these tests,~     additional tests may be done with insulin, glucose, luteinizing hormone and~     follicle-stimulating hormone.~      Patients who do not respond to these substances will undergo adrenalectomy (surgery to remove~     one or both adrenal glands). This is standard treatment for this type of Cushing's syndrome.~     It is usually done by laparoscopy, in which air is injected into the abdomen through tubes~     inserted through a small incision, enabling the surgeon to see the organs and remove the~     gland. Part of the removed tissue will be examined to learn about what causes this type of~     Cushing's syndrome; it may also be used for genetic studies related to the disease. Patients~     will stay in the hospital for a week to 10 days for observation and treatment and then will~     be discharged to the care of their own doctor. They will continue to complete the quality of~     life questionnaire every 3 months for 2 years.~      Patients with normal adrenal glands who are participating in National Cancer Institute~     studies and are scheduled for adrenalectomy as part of their standard treatment will also be~     recruited for this study to serve as controls. The patients will have a 24-hour urine~     collection, and part of the adrenal gland tissue removed for their treatment will be used for~     research purposes of this study, possibly including genetic study.~   "
273489|NCT00006276|"~     This study will evaluate the safety and effectiveness of micellar paclitaxel for treating~     severe psoriasis. Paclitaxel in another formulation (Taxol) is approved by the Food and Drug~     Administration for use in patients with cancer. This drug can decrease growth of cancer cells~     and of new blood vessels. Because patients with psoriasis have an increase in skin cell and~     blood vessel growth, paclitaxel may also improve their condition. The dose of drug used in~     this study is much lower than those used to treat cancer patients and is expected to cause~     relatively few side effects.~      Patients 18 to 70 years of age with psoriasis lesions affecting at least 20% of their skin~     may be eligible for this study. Candidates will be screened with a history and physical~     examination, blood and urine tests, electrocardiogram, and possibly an exercise stress test.~      Participants will receive six intravenous (through a vein) infusions of paclitaxel over a~     6-month period. Each infusion will take about 2 hours. Patients will stay in the clinic for~     observation for at least 1 hour before going home and will return to the clinic for follow-up~     examination and tests one week after each infusion. However, on weeks 0 and 8 visit will last~     for approximately 8 hours and will require a return to the clinic the following morning.~     Blood collection will be performed during the week 0 and 8 visits to determine how fast~     Micellar Paclitaxel is eliminated from your body. Approximately 2 teaspoons of blood will be~     taken prior to the infusion, twice during the infusion, and eight times during the 22 hours~     following the infusion for a total of eleven samples. These return visits will last~     approximately 1-2 hours. Patients will have the following procedures:~        1. A skin biopsy (removal of a small tissue sample for microscopic examination) will be~          done at the first visit (week 0) and again at weeks 6, 14 and 22. The area of the biopsy~          will be numbed with an anesthetic, and a small circle of skin about the width of a~          pencil eraser and half as deep will be cut and lifted away. Stitches will be placed and~          removed 1 to 2 weeks later.~        2. A history and physical examination will be done at every visit. Patients will be~          interviewed about changes in their skin condition and about treatment side effects and~          will be examined by a nurse or physician.~        3. Blood and urine samples will be collected at frequent intervals (nearly every visit) to~          test for side effects.~        4. Photographs of the skin will be taken at the first visit and at several later visits to~          document changes in psoriasis.~        5. A blood sample will be drawn for genetic testing to look for gene changes in people with~          psoriasis.~        6. An electrocardiogram will be taken at the last visit. This will be done at week 24 and~          compared to the screening EKG.~        7. Gonadal toxicity monitoring will be started with all patients entered into the protocol~          as of May 2001. Blood will be drawn to measure Inhibit A for females and Inhibit B for~          males at weeks 0, 6, 14, and 22.~   "
273490|NCT00006280|"~     This study's primary goals are to test the safety and effectiveness of Tobramycin for~     Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of~     age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already~     been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung~     fluid will be examined for bacteria before and after the 28-day treatment. The amount of~     bacteria before and after treatment will be compared. This will indicate whether the~     antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients~     will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the~     patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr~     but contains no medication).~   "
273491|NCT00006275|"~     OBJECTIVES:~      I. Determine the therapeutic efficacy and safety of topical calcitriol in children with~     psoriasis.~   "
273492|NCT00006274|"~     OBJECTIVES:~      I. Determine the total energy expenditure in term and preterm infants in both well and ill~     states using the doubly labeled water method.~   "
273493|NCT00006273|"~     OBJECTIVES: I. Compare the resting energy expenditure using respiratory calorimetry in~     infants and children with moderate to severe cystic fibrosis versus age matched healthy~     controls.~      II. Determine the total energy expenditure and energy spent on physical activity using the~     doubly labeled water method in these patient populations.~   "
273494|NCT00006272|"~     OBJECTIVES:~      I. Compare the total daily energy expenditure in infants with ventricular septal defects vs~     healthy control infants.~   "
273495|NCT00006271|"~     OBJECTIVES:~      I. Determine the incidence of neuroendocrine dysfunction in patients with closed head~     injuries admitted to the Transitional Learning Community in Galveston, Texas, for~     rehabilitation.~   "
273496|NCT00006270|"~     OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol~     secretion using approximate entropy in patients who have sustained a head injury.~      II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of~     sleep in these patients.~   "
273497|NCT00006206|"~     Combine is a multicenter, randomized clinical trial that will evaluate combinations of three~     interventions for treating alcohol dependence. The goal is to determine whether improvement~     in treatment outcomes can be achieved by various combinations of drug and behavioral~     interventions. Two of the interventions will consist of pharmacological treatment with~     naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent~     behavioral therapy including such components as motivational enhancement therapy, cognitive~     behavioral therapy, and referral to self-help groups, including AA. All three interventions~     will include a component supporting compliance to medications and reduction in drinking.~   "
273498|NCT00006205|"~     The purpose of this study is to learn whether ondansetron and topiramate either alone or in~     combination is safe and effective in the treatment of alcohol dependence. This 13 week~     out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are~     post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will~     receive ondansetron and topiramate either alone or in combination or a placebo coupled with~     psychotherapy.~   "
273501|NCT00006202|"~     This study will examine whether taking the vitamin lutein changes lutein blood levels.~     Lutein, vitamin C, vitamin E and beta-carotene may be useful in treating the eye disease~     age-related macular degeneration, but more information is needed to support this. Age-related~     macular degeneration can significantly impair the ability to read, drive, and carry out daily~     activities. It is the most common cause of vision loss in people over age 60. Lutein a~     carotenoid that occurs naturally in the retina (the back part of the eye), especially the~     macula-the part of the retina that is important for fine, detailed vision.~      Men and women 60 years of age and older, with or without age-related macular degeneration,~     may be eligible for this study. Candidates will undergo the following tests:~        1. Medical history and physical examination.~        2. Eye examination-Includes evaluation of visual acuity, measurement of eye pressure,~          examination of the lens, retina, pupils and eye movements, and photographs of the eye.~        3. Visual field study-Examines the ability to see objects in the periphery. The subject~          looks at a target on a screen and indicates when lights that appear in other places on~          the screen are visible.~        4. Flicker photometry-The subject looks at a flashing light and turns a knob until the~          light stops flashing.~        5. Blood tests-To measure blood levels of lutein and other carotenoids, liver function,~          cholesterol and triglycerides.~      Participants will be randomly assigned to take one of three dosages of lutein (2.5~     milligrams, 5 milligrams or 10 milligrams) for 6 months and will be examined at follow-up~     visits scheduled 1, 3, 6, 9 and 12 months after starting lutein. During these visits, many of~     the exams described above will be repeated to evaluate the effects of lutein treatment on the~     eye.~   "
273502|NCT00006200|"~     The purpose of this clinical trial is to assess the activity of thalidomide in combination~     with dacarbazine (DTIC) in patients with metastatic melanoma. Safety and toxicity of the two~     drugs will also be assessed. Dacarbazine is the standard medical treatment for metastatic~     melanoma. It has been shown to produce tumor shrinkage in approximately 20% of patients with~     advanced melanoma. This shrinkage is usually incomplete and lasts a short time. Thalidomide~     is a drug that inhibits tumor blood vessel growth. It can be given orally. It is hoped that~     this combination can be given to patients with metastatic melanoma without causing too much~     toxicity while increasing the response rate.~   "
273503|NCT00006199|"~     The purpose of this clinical trial is to establish the safest doses for the combination of a~     farnesyl transferase inhibitor, R115777 plus topotecan in patients with advanced solid~     tumors, previously treated or beyond standard therapy of clinical benefit. Maximum tolerated~     dose, dose limiting toxicity and the activity of this combination will be assessed.~      This chemotherapy regimen is a two-pronged attack at the way cancer cells replicate. R115777~     is a compound that may inhibit cancer cell growth by interfering with the p21 ras oncogene,~     while topotecan, a topoisomerase-1 inhibitor, works on cancer cells not subject to control by~     the ras oncogene. Animal studies suggest that the combination may be synergistic. Another~     advantage is that R115777 can be taken by mouth.~   "
273504|NCT00006198|"~     This is a clinical trial to test the safety and efficacy of the drug thalidomide in~     combination with a procedure called chemoembolization in patients with inoperable liver~     cancer. Chemoembolization is the process by which chemotherapy is instilled directly into the~     blood vessels feeding the tumor, so that the blood vessels feeding the tumor may be blocked.~     Chemoembolization consists of two separate procedures. It will be done by infusing~     chemotherapy with the drug doxorubicin through the hepatic artery into the liver and then by~     infusing collagen to cut off the blood supply to the tumor. A catheter will be inserted at~     various times to allow for these infusions.~      The objectives are to investigate the feasibility and potential activity of chronic~     administration of thalidomide in patients with unresectable hepatocellular cancer who receive~     chemoembolization to predominant tumor masses. The toxicity of thalidomide in these patients~     will be evaluated. Overall safety will also be assessed. Serum levels of angiogenic cytokines~     such as VEGF, bFGF, and TNF-a, that are believed to have a role in hepatocellular carcinoma,~     will be collected.~   "
273505|NCT00006196|"~     Vitamin D deficiency is common in the elderly and contributes to the increased incidence of~     falls, hip fracture and depression in this population. An unknown number of elderly have~     vitamin D resistance resulting in a functional vitamin D deficiency state. Because there are~     no simple procedures or blood tests that identify vitamin D resistance, its prevalence and~     contribution to disability in the elderly is unknown. Our inability to screen for this~     condition precludes our ability to initiate and monitor treatment.~      Previous studies indicate that fingernail thickness correlates with vitamin D status and may~     therefore provide a simple cost effective procedure to not only identify patients with~     vitamin D deficiency but also, those with vitamin D resistance. This procedure may also~     provide a way to monitor an individual's response to treatment.~      This study is designed to demonstrate the association between fingernail thickness and~     vitamin D status.~   "
273506|NCT00006195|"~     The overall purpose of this research is to look at how two of the most commonly prescribed~     newer antipsychotic medications, risperidone and olanzapine, affect substances in the body~     such as glucose and insulin. Undesirable changes in blood sugar control, or glucose~     regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia~     compared to healthy subjects and subjects with other psychiatric conditions. While~     abnormalities in glucose regulation were first reported in schizophrenia before the~     introduction of antipsychotic medications, antipsychotic treatment may contribute~     significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic~     medications may affect glucose regulation has increased as doctors have become more concerned~     in general about disease- and drug-related medical complications, including weight gain~     during antipsychotic treatment.~   "
273507|NCT00006194|"~     Decreased skeletal muscle mass is a prevalent condition among the elderly, and an important~     cause of disability and functional decline. The declines in muscle mass associated with aging~     may be related to alterations in specific kinds of growth factors in the muscle. Elderly hip~     fracture patients often have significant decreases in muscle mass. The purpose of this study~     is to investigate whether an exercise program can induce changes in muscle growth factors~     that are associated with increases in muscle mass and strength in elderly hip fracture~     patients.~   "
273668|NCT00005719|"~     To conduct a five-year demonstration and education project to sustain smoking cessation~     postpartum by women who had stopped smoking in pregnancy.~   "
273508|NCT00006193|"~     Dr. Atkins' New Diet Revolution has sold over 10 million copies and has been on the New York~     Times best seller list for 158 weeks. This and other low-carbohydrate diets, such as the~     ZONE, Sugar Busters, and the Carbohydrate Addicts Diet, have attracted much popular attention~     but little scientific evaluation. Given the widespread use of these diets, it seems prudent~     to evaluate them both for safety and efficacy. Therefore, the purpose of the study is to~     compare the effectiveness of two different weight control programs over the course of 52~     weeks. These two programs are 1) the Atkins' New Diet Revolution, a low-carbohydrate,~     high-protein diet, and 2) Brownell's LEARN Program, a high carbohydrate, low fat diet based~     on behavior modification. Specifically, this study will compare short-term changes in weight,~     food intake, blood chemistries and mood in adult males (n=10) and females (n=10) who are~     randomized to either the Atkins' Diet or the LEARN Program for a period of one year. During~     this year, they will be under medical supervision. We will examine the effect of the two~     weight loss plans on changes in lipids, blood pressure, insulin sensitivity and ketones, and~     eating behavior. This is a feasibility study and thus the data will ultimately be used to~     design a large randomized trial with adequate statistical power.~   "
273509|NCT00006192|"~     To document cardiovascular disease and cardiovascular disease risk factors among 1,200 Native~     Alaskans who are members of approximately 40 families.~   "
273510|NCT00006190|"~     HIV infection is a major global health problem. Survival and quality of life for HIV subjects~     has tremendously improved with the advent of a class of antivirals called protease inhibitors~     and the utilization of highly active combination therapy. However, such therapy has been~     associated with a syndrome called lipodystrophy. This lipodystrophy syndrome causes body~     shape changes; typically thinning and loss of fat from the arms, legs and face, with~     increased fat appearing in the abdomen and neck. There are also metabolic changes which~     occur, and subjects can develop increased triglycerides, increased cholesterol and an~     increased risk for diabetes as indicated by increasing insulin resistance. This study will~     take HIV positive subjects who have not yet started antiviral medications (treatment~     naive)and randomly assign them to one of two treatment arms. These treatment arms will be:~     Sustiva/Zerit/Epivir vs. Viracept/Zerit/Epivir The subjects will be treated and followed for~     two years and have extensive metabolic testing, skinfold thickness measurements, MRI scans~     and other measures to determine if and how they are experiencing changes in metabolism or~     body shape and to discover the mechanism of why this occurs. Understanding the mechanism~     should allow researchers to design interventions for subjects who have lipodystrophy and~     strategies to prevent lipodystrophy from occurring to subjects treated with antivirals in the~     future.~   "
273511|NCT00006188|"~     This study offers evaluation and treatment for patients with inflammatory eye diseases, such~     as uveitis. The protocol is not designed to test new treatments; rather, patients will~     receive current standard of care treatments. The purpose of the study is twofold: 1) to allow~     National Eye Institute physicians to increase their knowledge of inflammatory eye conditions~     and identify new avenues of possible research in this area; and 2) to establish a pool of~     patients who may be eligible for new studies as they are developed. (Participants in this~     protocol will not be required to join a new study; the decision will be voluntary.)~      Children and adults with uveitis and other inflammatory eye diseases may be eligible for this~     study. Candidates will be screened with a medical history, brief physical examination,~     thorough eye examination and blood tests. The eye examination includes measurements of visual~     acuity (ability to see the vision chart), eye pressure and dilation of the pupils to examine~     the lens and retina (back part of the eye). Patients may also undergo the following~     procedures:~        1. Fundus photography - Special photographs of the inside of the eye to help evaluate the~          status of the retina and evaluate changes that may occur in the future. From 2 to 20~          pictures may be taken, depending on the eye condition. The camera flashes a bright light~          into the eye for each picture.~        2. Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye~          injected into an arm vein travels to the blood vessels in the eyes. Pictures of the~          retina are taken using a camera that flashes a blue light into the eye. The pictures~          show if any dye has leaked from the vessels into the retina, indicating possible blood~          vessel abnormality.~      Participants will be followed at least 3 years. Follow-up visits are scheduled according to~     the standard of care for the individual patient's eye problem. Vision will be checked at each~     visit, and some of the screening tests described above may be repeated to follow the progress~     of disease and evaluate the response to treatment.~   "
273512|NCT00006187|"~     This is a 15-month study with two phases. During the first 12-month phase of this study,~     patients will be randomly assigned to receive either active study drug or placebo~     (approximately half of all patients will be on active study drug, the other half on placebo).~     The second phase is a 3-month randomized withdrawal period. For this phase approximately 10%~     of the patients will remain on the active drug.~   "
273513|NCT00006186|"~     Dilution of blood caused by cardiopulmonary bypass (the heart-lung machine) during open heart~     surgery is associated with decreased concentrations in the blood of coagulation factors. This~     can be extreme in infants because of their small blood volumes and can lead to impairment of~     the normal blood clotting mechanism and excessive bleeding after the operation. Transfusion~     of fresh whole blood has been shown to be an effective treatment because fresh blood is rich~     in coagulation factors. However, it is difficult to obtain truly fresh blood from a blood~     bank. We hypothesized that fresh blood drawn from the patient and given back after~     cardiopulmonary bypass would improve the clotting mechanism. In our study, the infants in the~     treatment group have some of their own fresh blood removed after they are anesthetized for~     the operation and before they are placed on cardiopulmonary bypass. This blood is then given~     back to them after completion of cardiopulmonary bypass. Infants in the control group will~     not have their own blood removed but will undergo cardiopulmonary bypass. We will compare the~     two groups by drawing blood samples that measure coagulation tests.~   "
273528|NCT00006171|"~     Background:~      Kaposi s sarcoma (KS) is caused by a gammaherpesvirus called Kaposi s sarcoma-associated~     herpesvirus (KSHV), or human herpesvirus-8 (HHV-8). However, infection with KSHV is not~     sufficient to cause KS, and HIV infection is an important cofactor. Treatment of HIV with~     potent antiretroviral therapy can reduce the risk of KS, and can also induce regression in~     patients with established HIV-KS. One mechanism by which HIV is believed to contribute to KS~     is through HIV-induced immunodeficiency which leads to a loss of immunologic control of KSHV~     and/or KS itself. However, other mechanisms may also contribute.~      Objectives:~      One primary objective is to assess the effects of the initiation of potent anti-HIV therapy~     on specific factors possibly linked to the control or pathogenesis of KS, namely serum viral~     IL-6 and plasma VEGF levels, in patients with KS or at risk for KS by virtue of being~     infected with KSHV/HHV-8. Another is to assess the effects of anti-HIV therapy on KSHV~     infection. Secondary objectives are to assess the effects of potent antiretroviral therapy on~     established KS and other factors related to KS or KSHV infection.~      Eligibility:~      The principal eligibility factors are age 13 or above, HIV infection, and either KS or~     infection with KSHV. Exclusion factors include KS that requires specific therapy, recent~     corticosteroid therapy, recent cytokine therapy, or opportunistic infections requiring~     therapy.~      Design:~      Patients will be treated with potent antiretroviral therapy. For patients with established~     KS, the effects of the therapy on the KS will be monitored. In addition, a variety of factors~     related to KS, HIV infection, therapy, or KSHV infection will be monitored. These include the~     HIV viral load, KSHV secretion in saliva, the CD4 count, serum VEGF levels, and serum IL-6~     levels.~   "
273529|NCT00006170|"~     The purpose of this study is to determine whether the addition of bupropion (Zyban) to~     cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.~   "
273514|NCT00006184|"~     Background:~      The mainstay of therapy for newly diagnosed multiple myeloma patients remains systemic~     chemotherapy. Although partial remissions of up to 60% are obtained with conventional~     regimens, multiple myeloma is essentially an incurable disease with a median survival of~     approximately 30 months.~      Allogeneic stem cell transplantation (SCT) results in a high percentage of complete~     remissions, but it can be associated with significant treatment-related mortality, which has~     been primarily attributed to conventional myeloablative transplant regimens.~      Recent clinical studies have shown that highly immunosuppressive yet non-myeloablative doses~     of fludarabine-based chemotherapy can result in alloengraftment. Even with a reduction in~     treatment related mortality, success with allogeneic SCT is limited by a significant risk of~     relapse.~      Donor immunization with myeloma Id in the setting of a non-myeloablative allogeneic SCT may~     represent a novel strategy for the treatment of multiple myeloma.~      Objectives:~      Primary Objectives:~      To induce cellular and humoral immunity in allogeneic stem cell donors and recipients against~     the unique idiotype expressed by the recipient's myeloma.~      To determine whether antigen-specific immunity, induced in the stem cell donor, can be~     passively transferred to the allogeneic SCT recipient in the setting of a non-myeloablative~     conditioning regimen.~      Secondary Objectives:~      To evaluate the effect of the Fludarabine-(etoposide, doxorubicin, vincristine, prednisone,~     cyclophosphamide) EPOCH regimen on host T cell depletion and myeloid depletion prior to~     allogeneic SCT.~      To determine the efficacy of a novel conventional chemotherapy regimen (Fludarabine-EPOCH) in~     the setting multiple myeloma.~      To determine the treatment-related morbidity and mortality of allogeneic stem cell~     transplantation using a non-myeloablative conditioning regimen in multiple myeloma.~      To determine if the re-vaccination of allogeneic stem cell donors with the unique idiotype~     expressed by the recipient's myeloma will enhance cellular and humoral immunity to patient~     specific-idiotype prior to lymphocyte donation for the treatment of patients with recurrent~     or progressive disease after transplantation.~      Eligibility:~      Patients 18-75 years of age with Immunoglobulin G (IgG) or Immunoglobulin A (IgA) multiple~     myeloma.~      Patients must have achieved at least a partial remission following initial conventional~     chemotherapy regimen or after autologous stem cell transplantation.~      Consenting first degree relative matched at 6/6 or 5/6 human leukocyte antigen (HLA)~     antigens.~      Design:~      Phase 2 trial using a non-myeloablative conditioning regimen to reduce treatment-related~     toxicity.~      Recipient will undergo a plasmapheresis to obtain starting material for the isolation of~     idiotype~      protein. Donors would be immunized with an Id vaccine prepared from the patient.~      Prior to transplantation patients would receive a conventional chemotherapy regimen which~     contains agents active in myeloma and is T cell depleting. The allogeneic SCT would be~     performed with a conditioning regimen consisting of cyclophosphamide and fludarabine. The~     stem cell source would be blood mobilized with filgrastim. Recipients will be immunized with~     the Id vaccine following transplantation.~   "
273515|NCT00006185|"~     With the advent of highly active anti-retroviral therapy(HAART), patients with HIV disease~     are developing a series of metabolic abnormalities including peripheral fat wasting, increase~     in truncal fat, high serum triglyceride levels, insulin(a hormone that controls blood sugar)~     resistance with an increased incidence of Type 2 Diabetes Mellitus and elevated blood~     pressure. The premise of this study is that abnormalities in the ability of fat and muscle~     tissue to respond to the hormone insulin may be the cause of the diabetes mellitus, high~     serum triglyceride levels and abnormal fat distribution. The purpose of the study is to~     assess how insulin resistant patients with HIV disease are and if their fat and muscle tissue~     are responding abnormally to insulin. This is done by administering insulin and taking small~     tissue samples of fat and muscle from the upper thigh and assessing how good insulin acts in~     these tissues.~      Patients with HIV disease will be admitted into the study after undergoing a screening~     medical history and examination. Once patients qualify, they will have their insulin~     resistance measured as well as the response of their fat and muscle to insulin; blood levels~     of glucose (sugar), cholesterol and triglycerides will be measured; body fat will be assessed~     using radiological tests; a detailed medical history will be obtained to assess risk factors~     for developing this syndrome.~      Patients who are found to be insulin resistant will be offered a trial of an insulin~     sensitizing agent, called Avandia, for 6-12 weeks. It is hoped that the Avandia will restore~     the body's ability to respond normally to insulin (as it does in patients with Diabetes) and~     perhaps improve the fat abnormalities as well. All the same measures will be performed at the~     end of the course of Avandia as were done at baseline.~      Patients who are not insulin resistant will be asked to come back yearly to assess whether~     they develop insulin resistance over time. This study will continue to recruit patients over~     the next 3 years.~   "
273516|NCT00006183|"~     The purpose of this study is to compare the effects of diluted hematocrit (HCT) levels of 35%~     versus 25% during hypothermic cardiopulmonary bypass (CPB) in infants with d-transposition of~     the great arteries, a malformation of the heart vessels.~   "
273517|NCT00006182|"~     To determine how long blood transfusions are needed for primary stroke prevention. Also, to~     determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD)~     and to determine the specificity of the stroke risk model developed in STOP 1 in patients~     with abnormal TCD measurements.~   "
273518|NCT00006399|"~     The goal of this study is to examine whether the administration of estrogen to~     post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their~     memory and their capacity for learning.~   "
273519|NCT00006181|"~     Promoting Healthy Lifestyles: Alternative Models' Effects (PHLAME) is a research study to~     evaluate and compare two ways to promote healthy behaviors, (regular physical activity, less~     than 30% calories from fat, 5 or more servings of fruits plus vegetables each day and~     maintain a healthy weight). Unhealthy nutrition practices and sedentary (inactive) lifestyles~     are the two most common harmful behaviors in the United States. Our two health promotion~     methods are 1) a team-based approach and 2) a one-on-one approach involving meetings with a~     health counselor. A third group only receives the same evaluation and their results and is~     the control group. Study participants are firefighters from 36 fire stations in Oregon and~     Washington.~      The goals of the study are increased physical activity and fitness, improved nutrition, and~     improved energy balance (reduced body fat). Changes in these factors can help lower risks for~     heart disease, some types of cancer, diabetes, hypertension and musculoskeletal injuries.~     Results from PHLAME will provide information on how best to help adults achieve and maintain~     healthy lifestyles.~   "
273520|NCT00006180|"~     The purpose of this study is to determine whether women with major depression lose bone mass~     at a faster rate than women without depression. This study will also determine if the drug~     alendronate can maintain or increase bone mass in premenopausal women with major depression~     and osteoporosis.~      Depression may be a major risk factor for osteoporosis; it is associated with abnormally~     elevated stress hormone levels that may contribute to bone loss. This study will evaluate~     bone mass in women with depression and healthy volunteers.~      Participants will undergo psychiatric, medical, dietary, and stress hormone evaluations and~     bone mineral density (BMD) measurements.~      Participants with depression will be divided into two groups: those with normal BMD and those~     with low BMD. Depressed participants with normal BMD will be compared to a control group of~     healthy premenopausal women with normal BMD and followed for 36 months. Dual energy X-ray~     absorptiometry (DEXA) determinations will be made at months 6, 12, 24 and 36; bone turnover~     and endocrine parameters of depression will be~      measured every 3 to 6 months.~      Participants with depression and low BMD will be randomly assigned to receive either~     alendronate or placebo (an inactive pill) once a week for 24 months. Participants will~     receive calcium and vitamin D supplements daily. DEXA determinations will be performed at~     screening, and at Months 6, 12, 18 and 24; bone turnover and endocrine parameters of~     depression will be measured every 3 to 6 months.~      For both groups, up to four of the visits may optimally be done as inpatient stays of two~     nights. All remaining visits are as outpatients.~   "
273539|NCT00006161|"~     The Decompression Intervention of Variceal Rebleeding Trial (DIVERT) is a multi-center~     prospective randomized clinical trial comparing the radiologic procedure of transjugular~     intrahepatic portal-systemic shunt (TIPS) with the surgical procedure of distal splenorenal~     shunt (DSRS) for variceal bleeding in patients with Child's Class A and B cirrhosis.~      This is recognized nationally and internationally as the study that will answer the question~     as to which of these is the best treatment for decompression of varices in patients who have~     failed endoscopic and pharmacologic therapy.~   "
273521|NCT00006178|"~     This study will test the safety and effectiveness of two drugs, Sirolimus and Thymoglobulin,~     for preventing rejection of transplanted kidneys. Standard anti-rejection therapy uses a~     combination of drugs, such as cyclosporine, tacrolimus, azathioprine, steroids, and others,~     that are taken daily for life. However, even with this daily therapy, more than half of~     kidney recipients slowly reject their transplant within 10 years. Both Thymoglobulin, an~     antibody, and Sirolimus, an anti-rejection drug, prevent rejection by lowering the response~     of the immune system to the transplanted organ. Thymoglobulin is given in the pre- and~     postoperative period, and Sirolimus is taken long term.~      Patients who receive a kidney transplant at the National Institutes of Health Clinical Center~     are eligible for this study. Candidates will be screened with a medical history, physical~     examination, and blood and urine tests.~      Participants will undergo a kidney transplant. Before the surgery, a central line~     (intravenous catheter), through which blood and medicine can be given, is placed in the neck~     or chest. Patients may also undergo leukapheresis, a procedure for collecting white blood~     cells. The cells can be stored for transfusion later if white cell counts drop following~     Thymoglobulin treatment. For this procedure, blood is drawn from a needle placed in the arm~     and flows into a machine that separates the blood components by spinning. The white cells are~     collected in a bag and the red cells and plasma are returned through a second needle in the~     other arm.~      Thymoglobulin will be given intravenously the day before the transplant and days 1 through 9~     after the operation. Sirolimus will be taken by mouth, mixed with water or orange juice.~     Sirolimus therapy starts the day of the transplant and continues for life.~      Follow-up study visits will be scheduled weekly for the first month after the transplant,~     then every 6 months for 1 year and then once a year for 4 years. Procedures during these~     visits may include blood and urine tests, physical examination, and check of vital signs~     (i.e., blood pressure, heart rate, breathing rate, temperature). Kidney biopsies (removal of~     a small piece of tissue for examination under the microscope) will be done at 2 weeks, 1~     month and 6 months after surgery and then yearly for 4 years to check for any damage to the~     kidney. In addition, a local doctor will do routine laboratory tests 2 to 3 times a week for~     the first 2 to 3 months aft...~   "
273522|NCT00006177|"~     This research protocol seeks to learn more about bipolar disorder in children and adolescents~     ages 6-17. Researchers will describe the moods and behaviors of children with bipolar~     disorder and use specialized testing and brain imaging to learn about specific brain changes~     associated with the disorder. This protocol studies children who have been diagnosed with~     bipolar disorder, and those who have a sibling or parent with bipolar disorder and are thus~     considered at risk for developing the disorder.~   "
273523|NCT00006176|"~     The purpose of this study is to learn more about the medical problems and the genetic factors~     involved in a recently defined form of inherited dementia called familial dementia with~     neuroserpin inclusion bodies (FDNIB). Abnormal substances in nerve cells of patients with~     this disease affect brain and nervous system function, causing confusion, memory decline and~     impaired cognition (thinking ability). Patients also develop movement disorders and,~     possibly, seizures. Symptoms begin in midlife, between 45 and 55 years of age.~      Patients with FDNIB and family members 18 years of age or older at risk for the disease may~     be eligible for this 3-year study.~      Participants will have a medical and family history and review of medical records; interview~     with a medical geneticist (specialist in genetics); physical, neurological and psychiatric~     examinations; and the following tests and procedures:~        1. Blood tests to assess general health~        2. Chest and skull X-rays~        3. Electrocardiogram (EKG)-record of the electrical activity of the heart using electrodes~          placed on the chest~        4. Electroencephalogram (EEG)-record of the electrical activity of the brain using~          electrodes placed on the head~        5. Ultrasound of the abdomen-imaging of abdominal organs using sound waves~        6. Brain magnetic resonance imaging (MRI)-imaging of the brain using a strong magnetic~          field and radio waves~        7. Hearing evaluation~        8. Assessment of performance of daily living activities~        9. Single photon emission computed tomography (SPECT)-imaging of brain metabolism and blood~          flow using a radioactive substance injected into a vein~      The evaluation will be done over a 3- to 4-day period. At their completion, participants will~     meet with a physician and a genetics counselor to discuss the clinically significant~     findings. Participants may be asked to return for follow-up evaluations every 6 months to a~     year (depending on the individual's condition) for 3 years.~   "
273524|NCT00006175|"~     This study will measure levels of an enzyme called cyclooxygenase in gum tissue following~     third molar (wisdom tooth) extraction. Cyclooxygenase is thought to contribute to pain that~     normally follows tissue injury or surgery.~      Healthy volunteers between 16 and 35 years of age who require removal of their third molars~     may be eligible for this study. Participants will receive an injection of a local anesthetic~     (lidocaine) in the mouth and a sedative (midazolam) through an arm vein before surgery.~     Before the tooth is removed, a small tissue sample (biopsy) will be collected from the gum~     tissue covering one of the lower third molars to be extracted. After surgery, a second biopsy~     will be taken at some point between just after surgery to the time when pain from the~     extraction starts to develop. These tissue samples will be analyzed for cyclooxygenase~     levels.~      Patients will stay in the clinic for up to 4 hours after surgery while the anesthetic wears~     off. During this time, they will complete pain questionnaires. If needed, patients may~     receive additional medicine for pain relief at any time during the surgery or the 4-hour~     observation period. They will also be given standard pain medication to take home at the end~     of the study.~   "
273525|NCT00006174|"~     This study will test the safety and effectiveness of letrozole in treating precocious (early)~     puberty in girls with McCune-Albright syndrome (MAS). The physical changes of puberty, such~     as breast enlargement, menstruation and growth spurt, as well as the emotional changes of~     this developmental stage, usually begin in girls between the ages of 8 and 14. Girls with~     MAS, however, often begin puberty before age 7. In MAS, large ovarian cysts produce high~     levels of estrogens (female hormones) that cause the changes of puberty. Children with MAS~     also have polyostotic fibrous dysplasia (PFD), a disease of bones that, depending on what~     parts of the skeleton are affected, can lead to broken bones or disfigurement of the head,~     face, arms and legs, or can cause pressure on nerves and blood vessels. Many children with~     MAS have cafe-au-lait spots (increased pigmentation) on areas of their skin as well.~      Letrozole is an estrogen-lowering drug that has been approved for treating women with breast~     and other cancers. Although the drug has not been tested or approved for use in children,~     some pediatric specialists have given it to girls with precocious puberty and MAS and found~     that it improves their condition without harmful side effects. This study will examine~     whether letrozole can lower estrogen in girls with MAS and arrest puberty. It will also study~     the drug's effects on substances involved in bone growth, including calcium, phosphate and~     amino acids.~      Girls 1 to 8 years old with MAS may be eligible for this study. Patients who were enrolled in~     NIH protocol 98-D-0145 (Screening and Natural History of Patients with Polyostotic Fibrous~     Dysplasia and the McCune-Albright syndrome) are also eligible. Participants will be admitted~     to the hospital for 2 to 3 days every 3 months for 15 months, for a total of 6 visits. They~     will undergo a complete history and physical examination and routine blood and urine tests~     every visit, as well as evaluations of their general health, growth and bone development,~     endocrine system (hormone-secreting glands) status and PFD status. A hand X-ray will be taken~     at the first visit and every 6 months to measure bone age advance. The children will begin~     taking letrozole at the second visit and continue the drug for 6 months. They will be~     evaluated after 3 months and 6 months on the drug (visits 3 and 4), and again after 3 months~     and 6 months after stopping treatment (visits 5 and 6).~      Parents of children who weigh more than 18 kilograms (about 40 pounds) may be asked if extra~     blood may be drawn after 3 months (visit 3) and 6 months (visit 4) of treatment to measure~     letrozole levels. The blood will be drawn before the morning dose and at 0.5, 1, 1.5, 2, 3,~     4, 6, 8, and 24 hours after the dose through an indwelling needle placed in the vein for 8 to~     24 hours.~      Parents will keep a record of all episodes of menstrual bleeding and any other symptoms or~     complaints. Children who respond well to therapy (decreased menses, slowed breast~     development, slowed growth and bone age advance) will be offered another 12 months of~     letrozole treatment.~   "
273526|NCT00006173|"~     Renovascular hypertension (RVH) is a potentially curable disease affecting 0.5-5 percent of~     patients with hypertension. The current diagnostic work-up of RVH involves a complex~     algorithm which includes doppler ultrasound, captopril renography and conventional~     angiography. Because of the expense, risk and inconvenience of this workup, patients may not~     be correctly diagnosed.~      Advances in MR technology present the opportunity to develop a single comprehensive test.~     This would combine an MR angiogram that provides anatomic information about the renal~     arteries, and an MR renogram that provides information about the functional impact of a~     stenosis as a cause of hypertension. Our main purpose is to test MR renography with and~     without an oral angiotensin converting enzyme inhibitor (ACEI) combined with MR angiography~     against the reference standard of captopril radionuclide renography. Secondary goals of this~     study are to test whether hypoxia within ischemic kidneys affected by RVH is detectable by T2~     weighted (Blood oxygen level dependent or BOLD) MRI. This is considered of value since such a~     test of oxygenation would further shorten and simplify the diagnostic MR test. Information~     gained from this study could lead to important changes in the diagnostic and pathophysiologic~     understanding of RVH.~   "
273527|NCT00006172|"~     This study investigates the potential efficacy of two nonpharmacologic treatments for~     nonseasonal depression, bright light exposure or high-density negative air ion exposure.~     Treatments are self-administered at home by the patient under close clinical supervision.~   "
273540|NCT00006160|"~     A controlled trial to assess the potential benefit of a home based worker in improving~     control in African-American children with insulin dependent diabetes.~   "
273542|NCT00006158|"~     The study is a 6 month, placebo-controlled study of transdermal testosterone for women with~     HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone~     levels. This study is designed to test the efficacy of physiologic testosterone dosing to~     improve weight, muscle mass and quality of life indices, including energy level, appetite and~     libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open~     label transdermal testosterone for an additional 6 months.~   "
273530|NCT00006156|"~     This purpose of this study is to gain information about normal ovarian function that will be~     useful in developing a test for early detection of ovarian failure. The ovaries produce~     female hormones, such as estrogen, that are important in maintaining a woman's health. When~     the ovaries do not work properly, problems can develop. Unfortunately, there is no test that~     can detect ovarian failure early in its course. By the time premature ovarian failure is~     diagnosed in young women, two-thirds have already developed osteopenia (loss of some bone~     mass) and nearly one in ten have osteoporosis, a greater loss of bone mineral density that~     weakens bones and increases the risk of fractures.~      Women with normal ovarian function ages 18 to 55 and postmenopausal women 60 years of age or~     older may be eligible for this study. Candidates will be screened with a medical history,~     physical examination, blood tests and vaginal ultrasound examination. For the ultrasound~     study, a probe that emits sound waves is inserted into the vagina, and the sound waves are~     converted to form images of the ovaries. The procedure is done with an empty bladder and~     takes about 10 minutes. After this screening visit (Visit 1), those enrolled in the study~     will return to the NIH Clinical Center for the following additional procedures:~      Visit 2-Will be scheduled between days 3 and 5 of the menstrual cycle (for women who are~     still menstruating). Participants will have blood tests to measure hormone levels and to~     check for pregnancy, and will have another transvaginal ultrasound examination. They will~     then receive an injection of a synthetic form of follicle stimulating hormone (FSH), a~     hormone the body makes normally.~      Visits 3 and 4-Will be scheduled 24 and 36 hours after the FSH injection given during Visit 2~     for collection of blood samples.~      Visit 5-Will be scheduled 48 hours after the FSH injection for additional blood sampling and~     a final transvaginal ultrasound examination.~   "
273531|NCT00006169|"~     The current study examines the efficacy of two treatments to help children with cystic~     fibrosis (CF) meet their dietary calorie requirements of 120% to 150% of the recommended~     daily allowance of energy and the effect of these treatments on weight gain and maintenance.~     One treatment provides children with CF and their parents nutrition education about the best~     foods for meeting their dietary needs. The second treatment gives children with CF and their~     families similar nutritional information plus behavioral parenting methods for motivating~     children to eat the recommended foods. Children with CF and their families are seen weekly~     for 7 treatment sessions across 9 weeks for the active phase of treatment. Families are then~     followed for 2 years after treatment in order to better understand how long the treatments~     are effective and to determine the health benefits of better nutrition status and weight~     gain.~   "
273532|NCT00006168|"~     The major thrust is to determine whether treatment of patients with Primary Biliary Cirrhosis~     (PBC) with Ursodiol (Ursodeoxycholic Acid-UDCA) plus methotrexate (MTX) is more effective~     than treatment with UDCA alone.~   "
273533|NCT00006167|"~     There are no guidelines for appropriate nutritional management of weight loss or wasting in~     HIV infection. Some treatments may increase weight, but without improving muscle mass or~     quality of life. In this clinical trial AIDS patients with wasting are randomized to one of~     three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition~     with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral~     nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition~     with progressive resistance training (PRT). In all participants, dietary intervention is~     maximized by weekly personalized counseling to address individual issues and concerns. Two~     primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be~     used to develop guidelines for standards of nutritional care among AIDS patient with the~     wasting syndrome.~   "
273534|NCT00006166|"~     The NASTRA Clinical Trial is a multi-center, randomized, controlled clinical trial designed~     to determine if treatment with transjugular intrahepatic portasystemic shunts (TIPS) is~     superior to high volume paracentesis (total paracentesis, TP) for the treatment of refractory~     ascites due to cirrhosis. Only patients with clinically tense symptomatic ascites (shortness~     of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity)~     who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.~   "
273535|NCT00006165|"~     The Native Hawaiian Diabetes Intervention Program is a project focused on determining whether~     a cultural-based, healthy lifestyles program with family support will have a positive effect~     on lifestyle behaviors and psychosocial and clinical outcomes. A culturally sensitive,~     lifestyle intervention program was administered via community peer educators to a population~     of Native Hawaiians with or at risk for diabetes. The effect of this intervention program on~     selected outcomes is being compared to a ''standard'' program given to a similar population~     in a second Native Hawaiian community.~   "
273536|NCT00006164|"~     The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases~     sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated~     interferon) in patients who failed to respond to prior interferon treatment. All patients who~     enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin.~     Patients who respond to this 6 month treatment will continue to be treated for an additional~     6 months.~      Patients who do not respond to this treatment will be eligible for the long-term maintenance~     phase of this study where patients will be randomly selected to be treated with Peginterferon~     alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will~     be followed closely with quarterly study visits.~      The combination of peginterferon plus ribavirin has recently been approved by the FDA for~     treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated~     for at least 6 months with peginterferon and ribavirin outside of this study may be eligible~     to directly enter the randomized portion of the HALT-C Trial.~      The HALT-C study is designed to determine if continuing interferon long-term over several~     years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer~     and reduce the need for liver transplantation.~   "
273537|NCT00006163|"~     This project evaluates the effectiveness of different aspects of a program to assist type 2~     diabetes patients with dietary changes. It evaluates the effectiveness of Personalized~     Self-Management Training and Community Resources support, using a randomized design. This~     study will also evaluate what percent of patients are willing to participate in such a~     program, and what percent of primary care physicians are willing to recommend it to their~     patients.~   "
273538|NCT00006162|"~     Type 2 diabetes is more frequent in Japanese Americans than in Japan or the U.S. non-Hispanic~     white population. This appears to be due to the effects of ''westernization'' to bring out~     metabolic changes that lead to diabetes. This study will look at whether increased physical~     activity and dietary changes will reduce or prevent the metabolic changes that lead to type 2~     diabetes in Japanese Americans who have impaired glucose tolerance, a condition intermediate~     between normal glucose tolerance and diabetes.~   "
273669|NCT00005718|"~     To evaluate two educational programs that promoted the role of pediatric practices in~     lowering LDL cholesterol levels in 4-10 year old hypercholesterolemic children through~     dietary modification.~   "
273545|NCT00006150|"~     The Hyper IgE Syndromes (HIES) are primary immunodeficiencies resulting in eczema and~     recurrent skin and lung infections. Autosomal dominant Hyper IgE syndrome (AD-HIES; Job's~     syndrome) is caused by STAT3 mutations, and is a multisystem disorder with skeletal,~     vascular, and connective tissue manifestations. Understanding how STAT3 mutations cause these~     diverse clinical manifestations is critical to our complete understanding of bone metabolism,~     bronchiectasis, dental maturation, and atherosclerosis. Mutations in DOCK8 cause many cases~     of autosomalrecessive Hyper IgE syndrome. These individuals suffer from extensive viral~     infections as well as have a high incidence of malignancy and mortality. The pathogenesis of~     this disease is being investigated. Therefore, we seek to enroll patients and families with a~     confirmed or suspected diagnosis of HIES syndrome for extensive phenotypic and genotypic~     study as well as disease management. Patients will be carefully examined by a~     multidisciplinary team and followed longitudinally. Through these studies we hope to better~     characterize the clinical presentation of HIES and to be able to identify further genetic~     etiologies, as well as understand the pathogenesis of HIES. We seek to enroll 200 patients~     and 300 relatives.~   "
273546|NCT00006148|"~     This study will determine whether the spleen in people who donate stem cells (bone marrow~     cells collected from the blood) enlarges as a result of taking granulocyte colony-stimulating~     factor (G-CSF). Donors take this growth factor to maximize the amount of stem cells that can~     be collected for transplantation to patients with leukemia or other diseases. The study will~     also examine whether changes in the donor's white blood cell count, blood stem cell count,~     and blood chemistries can predict a change in spleen size.~      Stem cells donors take G-CSF for 5 to 6 days before donating. Besides increasing the number~     of stem cells and white blood cells in the bloodstream, the drug also causes some other~     temporary changes in blood chemistry. Many people who take G-CSF for a few days get a~     headache, feel an ache in their bones, or feel tired for a few days. About one-third of~     patients chronically treated with G-CSF to raise blood cell counts develop an enlarged~     spleen. It is not known if a brief 5- to 6-day course of G-CSF also affects the size of the~     spleen, but about 1 in 10,000 blood stem cell donors have had a spontaneous rupture of the~     spleen.~      Adults and children 18 years of age and older who are donating stem cells for relatives~     enrolled in clinical trials at the National Institutes of Health may participate in this~     study. They will donate stem cells according to the standard procedure, but will give an~     extra 15 milliliters (3 teaspoons) of blood both before receiving G-CSF and after donating~     stem cells. Donors' spleen size will be measured by ultrasound scanning of the abdomen three~     times: the day before receiving G-CSF, the day after donating the stem cells and 4 days after~     donating.~   "
273547|NCT00006077|"~     This study will evaluate the effects of an experimental drug called NS2330 on Parkinson's~     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of~     long-term treatment with levodopa. This drug prevents the neurotransmitter dopamine from~     entering nerve cells.~      Patients between 18 and 75 years old who have moderately advanced Parkinson's disease and~     motor problems resulting from levodopa therapy may be eligible for this 5-week study.~     Candidates will have a complete medical history and physical examination with a detailed~     neurological evaluation. If needed, some patients will undergo a magnetic resonance imaging~     (MRI) or computerized tomography (CT) scan of the brain and a chest X-ray. All patients will~     have blood and urine tests and an electrocardiogram (EKG) and will take a written test for~     evaluation of depression.~      Patients enrolled in the study will, if possible, stop taking all antiparkinson medications~     except levodopa (Sinemet) for one month before the study begins and through its duration. For~     the first 1 to 3 days, patients will undergo a levodopa dose-finding procedure. For this~     study, patients will stop taking their usual oral levodopa medicine and instead will have~     levodopa infused through a vein for up to 12 hours. During the infusions, the drug dose will~     be increased slowly until either 1) parkinsonism symptoms improve, 2) dyskinesias appear, 3)~     unacceptable side effects occur, or 4) the maximum study dose is reached.~      When the patient's optimal dose is determined, treatment will begin. Patients will take three~     pills containing NS2330 or placebo (a look-alike pill with no active ingredient) 3 days a~     week for up to 5 weeks, in addition to their regular levodopa medication. All participants~     will receive placebo at some point in the study; some patients will receive only placebo~     throughout the entire 5 weeks.~      On treatment days, patients will have a brief medical examination before receiving the drug~     and will then be monitored for side effects for about 6 to 8 hours after taking the drug. At~     the beginning of weeks 2 and 5, the levodopa infusions will be repeated at the previously~     determined optimum rate. Throughout the study, parkinsonism symptoms, dyskinesias and~     depression will be evaluated. Blood and urine samples will be collected each week for~     standard safety tests, and blood will also be drawn periodically to measure NS2330 levels.~   "
273548|NCT00006142|"~     OBJECTIVES:~      I. Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in~     offspring of patients with phenylketonuria.~   "
273549|NCT00006138|"~     OBJECTIVES:~      I. Determine the frequency and severity of osteopenia and osteoporosis in patients with~     thalassemia major who undergo dual energy x-ray absorptiometry, and correlate these findings~     with other relevant endocrinologic measurements.~   "
273550|NCT00006137|"~     OBJECTIVES: I. Determine the most sensitive outcome measures (functional or morphological) of~     a progressive renal injury in patients with IgA nephropathy.~      II. Determine which of these patients are destined to progress to further injury in order to~     target them for therapy.~      III. Elucidate the determinants of progression in those patients who exhibit evidence of~     either increasing impairment of ultrafiltration capacity or ongoing destruction of nephrons.~   "
273551|NCT00006136|"~     OBJECTIVES: I. Determine whether arginine butyrate with or without epoetin alfa can stimulate~     gamma-globin chain production to a degree that decreases anemia and results in hematologic~     improvement in patients with thalassemia intermedia.~      II. Determine whether a proportional increase in gamma-globin synthesis and mRNA and an~     improvement in nonalfa and alfaglobin chain imbalance by at least 10% over baseline correlate~     with improved hematologic response in these patients when treated with this regimen.~      III. Determine whether a decrease in hemolysis, as assayed by a decrease in LDH, compared to~     baseline levels correlates with improved hematologic response in these patients when treated~     with this regimen.~      IV. Determine whether any particular genotypes are more responsive than others to this~     therapy in these patients.~      V. Determine whether baseline epoetin alfa levels, gender, and/or baseline reticulocyte~     counts (or percent circulating nucleated erythroblasts) correlate with improved hematologic~     response in these patients when treated with this regimen.~   "
273599|NCT00005900|"~     OBJECTIVES: I. Evaluate bronchoalveolar lavage fluid and serum obtained from pediatric~     patients with storage disorders prior to allogeneic hematopoietic stem cell transplantation~     (HSCT) for the presence of proinflammatory cytokines and for the production of nitric oxide~     by alveolar macrophages to identify possible risk factors for pulmonary complications.~      II. Investigate the underlying mechanism for the development of significant pulmonary~     complications in these patients during HSCT.~      III. Evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the~     time a pulmonary complication develops post-HSCT, or at 60 days post-HSCT if there has been~     no pulmonary complications.~   "
273553|NCT00006134|"~     OBJECTIVES: I. Continue yearly ascertainment visits of all patients of the established Lupus~     in Minority Populations: Nature vs Nurture (LUMINA) study cohort.~      II. Recruit into the LUMINA cohort newly diagnosed patients with systemic lupus erythematosus~     (SLE).~      III. Determine the impact of additional major histocompatibility complex (MHC) and non-MHC~     genetic factors not previously examined, specifically tumor necrosis factor, mannose binding~     protein, interleukin-1 receptor antagonist, and bcl-2, on the course and outcome of SLE.~      IV. Refine the assessment of those clinical and behavioral-cultural factors found to be~     important predictors of disease activity, damage, and functioning, thus far in these~     patients.~      V. Determine the relationships among disease activity, disease damage, and physical and~     mental functioning in these patients as the SLE progresses and the factors that predict them.~   "
273554|NCT00006133|"~     OBJECTIVES: I. Determine the effect of oral contraceptives containing low-dose synthetic~     estrogens and progestins on disease activity in premenopausal women with inactive, stable, or~     moderate systemic lupus erythematosus (SLE).~      II. Determine the effect of hormone replacement therapy with conjugated estrogens and~     progestins on disease activity in postmenopausal women with inactive, stable, or moderate~     SLE.~   "
273555|NCT00006132|"~     OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in~     infants with herpes simplex virus infection involving the central nervous system.~      II. Determine whether neurologic outcome is improved in these patients when treated with this~     regimen.~      III. Determine whether continuous administration of this drug suppresses recurrent skin~     lesions in these patients.~      IV. Determine the safety of this regimen in these patients.~   "
273556|NCT00006131|"~     OBJECTIVES:~      I. Compare the efficacy and safety of two doses of oral valacyclovir in immunocompromised~     patients with uncomplicated herpes zoster.~      II. Compare quality of life, pain, and medical resource utilization in patients treated with~     these 2 regimens.~   "
273557|NCT00006130|"~     OBJECTIVES: I. Phase II trial to determine surgical morbidity of decompression coring,~     including any adverse events in the perioperative period and the rate of secondary medical or~     surgical interventions.~      II. Collect preliminary data to determine if decompression coring results in a substantial~     improvement in pain and mobility compared to conservative therapy in patients with avascular~     necrosis of the hip related to sickle cell disease.~   "
273558|NCT00006129|"~     OBJECTIVES: I. Determine whether testosterone normalization ameliorates muscle protein~     hypercatabolism by increasing net protein synthesis in men with burn injury.~      II. Determine whether the effectiveness of testosterone is enhanced by stimulation of inward~     amino acid transport as a consequence of hyperaminoacidemia in these men.~      III. Determine whether testosterone normalization during hospitalization minimizes the need~     for rehabilitation by increasing net protein synthesis and preserving skeletal muscle in~     these men.~      IV. Determine whether testosterone normalization after hospital discharge and throughout~     convalescence increases muscle strength and lean body mass after burn injury by increasing~     net protein synthesis.~      V. Determine whether testosterone combined with progressive resistance exercise during~     convalescence confers added benefits on muscle protein synthesis, and in turn, lean body mass~     and muscle strength in these patients.~   "
273559|NCT00006128|"~     OBJECTIVES: I. Determine the relationship of closed head injury (CHI) severity, focal brain~     lesions, and the age at injury to the development of working memory, inhibition, and~     metacognitive skills in children or adolescents with CHI of varying severity.~      II. Assess the development of working memory, inhibition, and metacognitive skills in~     relation to discourse functions, scholastic achievement, and adaptive behavior in these~     patients.~      III. Determine the relationship between impaired inhibition, metacognitive skills, and the~     emergence of psychiatric disorder in these patients.~   "
273560|NCT00006127|"~     OBJECTIVES:~      I. Evaluate the toxicity of amifostine in patients with bone marrow failure related to~     Fanconi's anemia.~      II. Determine the efficacy of this treatment regimen in this patient population.~      III. Evaluate the effect of this treatment regimen on bone marrow progenitor cell~     proliferation and peripheral blood mononuclear cell apoptosis in these patients.~   "
273561|NCT00006076|"~     This study will examine the hereditary basis of tone deafness by identifying regions of the~     human genome linked to this condition. Both exceptionally good pitch recognition (perfect~     pitch) and exceptionally poor pitch recognition (tone deafness) run in families. A better~     understanding of what causes tone deafness may provide new insights into auditory (hearing)~     function.~      Individuals with two or more family members 15 years of age or older who are tone deaf or~     have trouble recognizing different melodies may be eligible for this study. Candidates will~     be screened with a short listening test for pitch and a short written test. Those identified~     with poor pitch recognition will fill out a brief questionnaire about their family tree and~     family members (without identifying names) who have trouble recognizing melodies or tones.~     Individuals with poor pitch recognition will be asked to help contact family members who may~     be interested in participating.~      Members of families with two or more first-degree relatives (parents, grandparents, siblings)~     who are tone deaf may enroll in the study. They will provide a blood sample (about 2~     tablespoons) for genetic studies and may take a 20-minute hearing test using headphones.~   "
273562|NCT00006072|"~     Peripheral neuropathies cause weakness and sensory loss that can produce severe disability.~     Some neuropathies are immune-mediated and associated with antibodies. It has been postulated~     that Rituxan treatment may reduce the level of antibody production limiting the loss of~     muscle strength and hence improve activities of daily living. The purpose of this open-label~     study (all participants get Rituxan and not placebo) is to determine the safety and~     effectiveness of Rituxan in the treatment of polyneuropathies associated with serum IgM~     autoantibodies in those who have already been treated with one course of Rituxan. Subjects~     will be treated on the in-patient Clinical Research Center with Rituxan for two treatments~     one week a part and then individual treatments every 10 weeks for one year. The effectiveness~     of Rituxan will be followed by looking for increases in muscle strength and decreases in the~     serum IgM autoantibodies.~   "
273670|NCT00005717|"~     To test the effectiveness of a self-management program for chronic obstructive disease (COPD)~     patients. The program to improve adherence could be conducted by nurses or other clinic staff~     in settings where comprehensive rehabilitation services were not available.~   "
273671|NCT00005716|"~     To evaluate the efficacy of a community-based intervention to improve asthma management for~     parents, children and health care providers.~   "
273563|NCT00006070|"~     This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on~     relieving pain and swelling after oral surgery. The Food and Drug Administration has approved~     Enbrel for treating symptoms of rheumatoid arthritis, including pain.~      Healthy volunteers 16 to 35 years of age who require third molar (wisdom teeth) extractions~     may be eligible for this study. Participants must not be allergic to aspirin or to~     non-steroidal anti-inflammatory drugs (NSAIDs). Candidates will be screened for eligibility~     with a medical history and oral examination, including X-rays if needed.~      Participation in the study requires four clinic visits: two for surgery and two for~     follow-up:~      Visit 1:~      Patients will have ultrasound pictures taken to measure cheek size. One hour before surgery,~     they will receive a dose of either 25 milligrams (mg) of Enbrel; 15 mg of the standard pain~     medicine Toradol; or a placebo (salt-water) through an arm vein. A local injection of an~     anesthetic (lidocaine) will be given before surgery to numb the mouth, and a sedative~     (Versed) will be infused through a vein to induce sleepiness. When the anesthetic takes~     effect, a small piece of tissue will be removed from the inside of the cheek, and then the~     upper and lower molars on one side of the mouth will be extracted. After surgery, a small~     piece of tubing will be placed in the lower extraction site, from which samples will be~     collected to measure chemicals involved in pain and inflammation. Patients will stay in the~     clinic for 4 hours after surgery while the anesthetic wears off and will complete pain~     questionnaires during that time. If, an hour after surgery, patients have pain that is not~     relieved by the treatment given before surgery, they may receive acetaminophen (Tylenol) and~     codeine for pain. Another biopsy will be taken (under local anesthetic) from the inside of~     the cheek when pain occurs or at the end of the 4-hour observation period. The tubing then~     will be removed and the patient discharged with Tylenol and codeine for pain.~      Visit 2:~      Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to~     2-hour visit. They will fill out questionnaires, undergo ultrasound imaging of both cheeks~     and have another biopsy taken from the inside of the cheek on the operated side.~      Visits 3 and 4:~      Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth~     on the other side of the mouth, and the procedures for visits 1 and 2 will be repeated.~   "
273564|NCT00006068|"~     Low blood sugar (hypoglycemia) is a recurrent problem for many people with diabetes.~     Successful transplantation of clusters (islets) of normal cells, that include those which~     produce the sugar-lowering hormone insulin, from the pancreas of a person who did not have~     diabetes into a person with diabetes should eliminate high blood sugar levels. We wish to~     determine if it will also eliminate low blood sugar. To do so we will give insulin to lower~     the blood sugar, measure the levels of the hormones that normally raise blood sugar levels~     (e.g., glucagon and epinephrine) and then stop the insulin and see if blood sugar levels~     return to normal. Because we anticipate that the transplanted islets will produce insulin,~     but not glucagon, this study may also tell us if regulated insulin production alone can~     prevent hypoglycemia in humans.~   "
273565|NCT00005937|"~     This study will determine the safety and effectiveness of a combination of the~     immune-suppressing drugs antithymocyte globulin (ATG) and cyclosporine for treating~     myelodysplasia, a disorder of low blood cell counts. It will: evaluate whether this drug~     combination can increase blood counts in patients and reduce their need for transfusions;~     compare survival of patients who respond to ATG and cyclosporine treatment with those who do~     not respond; and determine the side effects of the treatment.~      Myelodysplasia is thought to result from an immune system abnormality in which cells called~     lymphocytes attack the marrow's blood-forming cells. The resulting deficiencies of platelets~     and red and white blood cells cause anemia, susceptibility to infections, and easy bruising~     and bleeding. Various therapies, such as blood transfusions for anemia and bleeding,~     antibiotics for infection, chemotherapy and bone marrow transplantation are used to treat~     myelodysplasia, but all have disadvantages and some carry serious risks.~      Patients 18 years of age and older with myelodysplasia may be eligible for this study.~     Candidates will be screened with a physical examination and medical history, blood tests,~     chest X-ray, electrocardiogram and bone marrow biopsy (removal of a marrow sample from the~     hipbone for microscopic examination).~   "
273566|NCT00005936|"~     This study will examine liver tissue to investigate the role of viral infections in fulminant~     hepatitis, liver failure, and profound bone marrow failure.~      All patients who are undergoing liver biopsy or liver transplantation may participate in this~     study. For patients undergoing liver biopsy, a small piece of liver tissue will be taken from~     the sample collected during the scheduled biopsy. For patients undergoing liver~     transplantation, a small piece of tissue will be collected from the diseased liver that is to~     be removed.~   "
273567|NCT00005935|"~     This study will examine the safety and effectiveness of a new drug combination for treating~     patients with severe aplastic anemia. Patients with aplastic anemia produce too few blood~     cells, causing fatigue, easy bruising and bleeding, and susceptibility to infections. In many~     cases, the very low blood counts result from an autoimmune process-that is, the patient's own~     immune system suppresses production of blood cells by the bone marrow. Although~     immune-suppressing drugs, such as cyclosporine, can restore normal cell counts, many patients~     have disease relapses. These patients require long-term therapy with cyclosporine, which can~     cause harmful side effects. This study will examine whether a lower dose of cyclosporine~     given together with mycophenolate mofetil (MMF) can maintain blood counts as effectively as~     full-dose cyclosporine treatment, and whether MMF alone can reduce the chances of future~     relapses.~      Patients 4 years of age and older with severe aplastic anemia who have relapsed after immune~     suppressing therapy may be eligible for this study. Participants will be randomly assigned to~     receive either standard cyclosporine therapy or experimental therapy with cyclosporine and~     MMF.~      Patients receiving standard cyclosporine therapy will receive a full dose of the drug for at~     least 3 months. Those taking both cyclosporine and MMF will take MMF plus half-dose~     cyclosporine for 3 months and continue MMF for an additional 6 months. Both drugs are taken~     twice a day by mouth. All patients will have about 120 milliliters (4 ounces) of blood drawn~     at the beginning of the study to evaluate immune system activity and bone marrow function,~     and to look for genetic material of certain viruses. Bone marrow aspirations and biopsies~     will be done at the beginning of the study, and at 6 and 12 months. For these tests, the area~     of the hip is anesthetized and a special needle is used to draw bone marrow from the hipbone.~      The patient's local doctor will be asked to do blood tests for chemistries, liver function~     and cyclosporine levels weekly for the first month and then every other week. Patients will~     return to NIH for evaluations 3, 6 and 12 months after treatment and then once a year. About~     100 ml (7 tablespoons) of blood will be drawn at each visit.~   "
273568|NCT00005934|"~     This study will evaluate the safety and effectiveness of 5-azacytidine and phenylbutyrate for~     treating thalassemia major. Patients with this disease have abnormal production of hemoglobin~     (the oxygen-carrying protein in red blood cells), which leads to red blood cell destruction.~     As a result, patients require frequent red cell transfusions over many years. Because of~     these transfusions, however, excess iron is deposited in various body organs-such as the~     heart, liver, thyroid gland and, in men, the testes-impairing their function.~      Fetal hemoglobin-a type of hemoglobin that is produced during fetal and infant life-can~     substitute for adult hemoglobin and increase the levels of red cells in the body. After~     infancy, however, this type of hemoglobin is no longer produced in large quantities.~     5-azacytidine can increase fetal hemoglobin levels, but this drug can damage DNA, which in~     turn can increase the risk of cancer. This study will try to lessen the harmful effects of~     5-azacytidine by using only one or two doses of it, followed by long-term therapy with~     phenylbutyrate, a drug that may be as effective as 5-azacytidine with less harmful side~     effects.~      Patients 18 years of age and older with severe thalassemia major may be eligible for this~     study. Before beginning treatment, candidates will have a medical history and physical~     examination, blood tests, chest X-ray, electrocardiogram (EKG), bone marrow biopsy (removal~     of a small sample of bone marrow from the hip for microscopic examination) and whole-body~     magnetic resonance imaging (MRI). For the biopsy, the area of the hip is anesthetized and a~     special needle is inserted to draw bone marrow from the hipbone. For the MRI scan, a strong~     magnetic field is used to produce images that will identify sites where the body is making~     red blood cells. During this procedure, the patient lies on a table in a narrow cylinder~     containing a magnetic field. Earplugs are placed in the ears to muffle the loud thumping~     sounds the machine makes when the magnetic fields are being switched.~      An intravenous (IV) catheter (flexible tube inserted into a vein) is placed in a large vein~     of the patient's neck, chest or arm for infusion of 5-azacytidine at a constant rate over 4~     days. Patients who do not respond to this first dose of 5-azacytidine will be given the drug~     again after about 50 days. If they do not respond to the second dose, alternate treatments~     will have to be considered. Patients who respond to 5-azacytidine will begin taking~     phenylbutyrate on the 14th day after 5-azacytidine was started. They will take about 10 large~     pills 3 times a day, continuing for as long as the treatment is beneficial. All patients will~     be hospitalized for at least 6 days starting with the beginning of 5-azacytidine therapy.~     Those who are well enough may then be discharged and continue treatment as an outpatient.~      Patients will be monitored with blood tests daily for 2 weeks and then will be seen weekly~     for about another 5 weeks. Bone marrow biopsies will be repeated 6 days after treatment~     begins and again at 2 weeks and 7 weeks. MRI will be repeated 7 weeks after treatment begins.~     After 7 weeks, patients will be seen at 3-month intervals. Bone marrow biopsies will be done~     every 6 months for the first 3 years after treatment. Patients will have red cell~     transfusions as needed and chelation therapy to remove excess iron.~   "
273569|NCT00006063|"~     OBJECTIVES:~      I. Compare the efficacy of enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules~     versus the patient's usual enteric coated pancreatic enzyme without bicarbonate in decreasing~     fecal fat and nitrogen losses in patients with cystic fibrosis.~   "
273570|NCT00006061|"~     OBJECTIVES: I. Determine whether plasma choline and breast milk choline levels are low at~     fasting in a patient with methionine adenosyltransferase deficiency, and if the choline~     levels are low, determine whether choline levels respond to dietary supplementation with~     phosphatidylcholine.~      II. Determine whether this patient has a fatty liver by magnetic resonance spectroscopy.~   "
273571|NCT00006060|"~     OBJECTIVES: I. Determine by quantitative magnetic resonance imaging measurements the change~     in the total volume of brain parenchyma as well as its gray and white matter, T2 and enhanced~     T1 lesion volume, and the magnetization transfer ratio histogram parameters, and correlate~     these measurements with clinical measures of disability in patients with multiple sclerosis.~      II. Measure the quantity of whole brain N-acetylaspartate in patients with multiple sclerosis~     and compare these values to those from age matched controls.~      III. Determine the correlation between specific neuropsychological tests which assess global~     cognitive functioning and the quantitative measurements taken in these patients in this~     study.~   "
273573|NCT00006058|"~     OBJECTIVES:~      I. Create a clinical sample bank of neonates with lung disease to test hypotheses regarding~     the pathogenesis of bronchopulmonary dysplasia (BPD).~      II. Determine whether a developmental deficiency of surfactant protein B (SP-B) contributes~     to the occurrence of respiratory distress and BPD in these patients.~      III. Study metabolic abnormalities associated with inherited deficiency of SP-B in these~     patients.~      IV. Determine whether plasma nitrotyrosine levels, a marker of peroxynitrite mediated oxidant~     stress, are elevated in premature infants who develop BPD.~      V. Measure the temporal changes in critical components of the inflammatory process (cell~     composition, inducible nitric oxide synthase, hyaluronan (HA), receptor for HA mediated~     mobility, and selected cytokines) in bronchoalveolar lavage, blood, and urine samples~     obtained from these patients, and to correlate these changes with their clinical course.~      VI. Examine changes in the insulin-like growth factor axis that occur in the lungs of infants~     with respiratory distress syndrome (RDS) and BPD.~      VII. Determine the relationship between degradation of elastin and the clinical course of~     BPD.~      VIII. Determine whether the normal fall in plasma endothelin-1 concentrations after birth are~     delayed in infants with RDS and BPD.~   "
273574|NCT00006057|"~     OBJECTIVES: I. Determine the phenotypic heterogeneity of patients with genetic disorders~     including their clinical spectrum and natural history.~      II. Develop and evaluate novel methods for the treatment of genetic disorders including~     metabolic manipulation, enzyme manipulation, enzyme replacement, enzyme transplantation, and~     gene transfer techniques in these patients.~      III. Develop and evaluate methods for the prenatal diagnosis of genetic disorders using~     improved cytogenetic, biochemical, and nucleic acid techniques and amniotic fluid cells or~     chorionic villi in these patients.~   "
273575|NCT00006056|"~     OBJECTIVES: I. Determine the efficacy of unrelated donor hematopoietic stem cell~     transplantation in the treatment of patients with life threatening hemophagocytic disorders.~      II. Determine the rate of disease free survival, incidence of graft failure, and incidence of~     graft versus host disease in these patients after undergoing this treatment regimen.~   "
273576|NCT00006055|"~     OBJECTIVES: I. Determine whether there is prompt engraftment after autologous peripheral~     blood stem cell transplantation using filgrastim (G-CSF) mobilization in patients with life~     threatening autoimmune diseases.~      II. Determine the kinetics of T- and B-cell immune reconstitution after a combination of~     timed plasmapheresis, high dose cyclophosphamide and total lymphoid irradiation, and~     posttransplant immunosuppression with cyclosporine in these patients.~      III. Determine whether this treatment regimen beneficially influences the clinical course of~     these patients.~   "
273577|NCT00006054|"~     OBJECTIVES: I. Provide curative immunoreconstituting allogeneic bone marrow transplantation~     for patients with primary immunodeficiencies.~      II. Determine relevant outcomes of this treatment in these patients including quality of~     survival, extent of morbidity and mortality from complications of the treatment (e.g., graft~     versus host disease, regimen related toxicities, B- cell lymphoproliferative disease), and~     completeness of functional immunoreconstitution.~   "
273578|NCT00005933|"~     This study will try to determine what causes learning, behavioral and emotional problems in~     children with chronic granulomatous disease (GCD) and other phagocyte disorders. (Phagocytes~     are a type of white blood cell.) Children with these disorders have frequent severe~     infections that require hospitalization, sometimes for long periods of time. Many of them~     also have problems with school, learning, behavior, anxiety and depression. This study will~     explore whether these latter problems are a direct result of the illness itself or are a~     consequence of frequent, long hospitalizations, or are due to other factors. Test findings in~     these children will be compared with those of children with cystic fibrosis-another disease~     that causes frequent infections requiring prolonged hospitalization.~      Patients age 2 or older with GCD or other phagocytic disorders or cystic fibrosis may be~     eligible for this study. Participants (or a parent or guardian) will complete questionnaires~     including personal information such as age, gender and marital status, a family medical~     history, and information on their illness. Patients will be given various psychological and~     intelligence tests, and they and their parents or guardians will be interviewed by a child~     psychiatrist. The tests and interviews take a total of about 5 hours and are given in two or~     three separate sessions.~      The tests may reveal problems such as learning disorders, attention-deficit hyperactivity~     disorder, anxiety, or depression. If any of these problems are identified, appropriate~     referrals will be made for specialized services, such as special school placement, tutoring,~     or counseling.~   "
273579|NCT00005928|"~     This study will determine the effects of angiotensin-converting enzyme (ACE) inhibitor (trade~     name Ramipril) therapy on inflammation and stiffness of artery walls. These are two risk~     factors for developing atherosclerosis-deposits of fatty substances called plaques that can~     block the blood vessel, causing a heart attack or stroke. Studies of patients with coronary~     artery disease suggest that ACE inhibitor therapy reduces the risk of heart attack and heart~     failure. This study will examine the effects of this treatment on the artery walls and on~     levels of substances in the blood that indicate blood vessel inflammation.~      Patients between 40 and 75 years old with coronary artery disease caused by atherosclerosis~     may be eligible for this study. Candidates will be screened with a medical history,~     cardiovascular (heart and blood vessel) examination, electrocardiogram and blood tests. Those~     enrolled will be randomly assigned to take either an ACE inhibitor pill or a placebo~     (look-alike pill with no medicine) once a day for 3 months. No pills will be taken for the~     next month, and then participants will take the alternate pill for the next 3 months. That~     is, those who took ACE inhibitor for the first 3-month period will take placebo for the~     second 3-month period and vice versa. Blood pressures will be taken at the NIH Clinical~     Center or by the patient's physician at the end of the first and second weeks of the study.~     At the end of 3 weeks, patients will return to the Clinical Center for a blood draw of 6 cc~     (1/2 teaspoon) to assess kidney function. In addition, at the end of each 3-month study~     period, patients will undergo the following procedures at the Clinical Center:~        1. Fasting blood draw of 60 cc (2 ounces) to measure electrolytes (e.g., sodium and~          potassium) and blood markers for inflammation~        2. Ultrasound (use of sound waves to create pictures) study of the carotid arteries~          (arteries in the neck leading to the brain)-An ultrasound probe is applied gently on the~          neck, and ultrasound pictures of the right and left carotid arteries are recorded on~          tape. Heart activity and blood pressure are monitored during the procedure with an~          electrocardiogram and blood pressure cuff.~        3. Magnetic resonance imaging (MRI) of the carotid arteries-The patient lies on a table in~          a narrow cylinder (the MRI machine) containing a magnetic field. A flexible padded~          sensor called a MRI coil is placed over the neck area. Earplugs are placed in the ear to~          muffle the loud thumping sounds the machine makes when the magnetic fields are switched.~          During the second half of the exam, a contrast agent (gadolinium) is injected through an~          intravenous catheter (flexible tube placed in a vein) to brighten the images. The heart~          is monitored during the procedure with an electrocardiogram.~   "
273672|NCT00005715|"~     To test the effectiveness of school-based asthma education interventions, community-based~     asthma health workers' programs and the combination of these on asthmatic children. Also, to~     examine the separate and combined impact of asthma interventions designed to address problems~     associated with effective asthma self-management amd difficulties in establishing and~     maintaining continuity of medical care.~   "
273580|NCT00005927|"~     The adrenal glands, located atop the kidneys, normally produce several types of hormones.~     Tumors of these glands may or may not secrete hormones. It is not known what causes these~     tumors or why some secrete hormones and others do not. Some of the tumors are benign and~     confined to the adrenal gland, and others are malignant (cancerous), and can spread to other~     parts of the body. This study will investigate how adrenal gland tumors develop, why some~     secrete steroid hormones and others do not, and why some are benign and others malignant.~      Patients between 3 and 70 years old with a known or suspected adrenal gland tumor may be~     eligible for this study. Participants will be hospitalized for 7 to 10 days for various tests~     and procedures that may include the following:~        1. Medical history and physical examination, including body measurements, as appropriate.~          Children and adolescents will have Tanner staging, including examination of the~          genitals, to determine the extent of sexual maturity.~        2. 24-hour urine collection to measure hormones in the urine.~        3. Imaging studies, including magnetic resonance imaging (MRI) of the brain, computed~          tomography (CT) and other X-ray studies.~        4. Blood tests to see if the tumor secretes hormones in response to specific stimuli,~          including exercise, food, and various hormones. The hormones are given through an~          intravenous catheter, or IV a thin plastic tube inserted into an arm vein. After the~          stimulus, blood is drawn through the same IV every 30 minutes for up to 3 hours to~          measure hormone levels. Based on the results of these tests, some patients may have~          additional blood tests to check hormone response to special foods, an IV salt solution,~          or other hormones or drugs given either IV or by mouth (in pill form).~        5. Photographs to document the effects on the body of abnormal hormone secretion from the~          adrenal tumor.~        6. Small samples of blood and tumor tissue for research and DNA (genetic) analysis.~      A discussion of treatment options will be based on the results of tests. If surgery to remove~     the tumor is recommended, the procedure can be done at NIH under this study protocol. If a~     malignant tumor is found that cannot be treated surgically, chemotherapy or radiation therapy~     may be recommended. These options are not offered under this protocol, but may be available~     under a different NIH study (for example, at the National Cancer Institute). Referrals will~     be made at the patient s request.~      Patients who had surgery may be followed at the NIH outpatient clinic for 1 year after~     surgery. Patients with certain types of tumors may continue to be followed at NIH once a year~     for up to 5 years.~      A registry of study participants will be created to keep records and correlate medical~     histories with tissues kept at NIH. The registry will also be used to inform participants of~     research studies they may be interested in. No individuals or organizations outside of NIH~     will have access to the registry.~   "
273581|NCT00005925|"~     This study will examine the safety and effectiveness of infusing a chemical called muscimol~     into the brain to control seizures in patients with intractable epilepsy (frequent seizures~     that persist despite therapy). Muscimol, which is similar to a naturally occurring brain~     chemical called GABA, has been shown to reduce seizures in rats. After the infusion study,~     patients will undergo a standard surgical procedure for controlling seizures.~      Patients 18 years of age or older with intractable epilepsy may be eligible for this study.~     Before entering protocol 00-N-0158, candidates will be screened under protocol 01-N-0139,~     Evaluation and Treatment of Patients with Epilepsy, with a medical history, physical and~     neurologic examination, chest X-ray, electrocardiogram, blood and urine tests,~     electroencephalographic (EEG) monitoring and magnetic resonance imaging (MRI) of the head.~      Patients enrolled in this study will have the following procedures:~        1. Computerized tomography (CT) and magnetic resonance imaging (MRI) of the head to guide~          catheter/electrode placement (see #2).~        2. Depth catheter/electrode placement into the presumed location of the seizure focus (the~          part of the brain where the seizures originate) - A small hole is drilled through the~          skull. A depth electrode with a hole in the center of the tubing is passed through the~          brain into the structures usually involved in intractable epilepsy. MRI will be done to~          check electrode placement. Video-EEG monitoring will continue for 5 days for this part~          of the study. Patients will be tested for their ability to understand and produce~          speech, see normally, move their arms and legs, distinguish sharp and dull objects, and~          put pegs in a pegboard. They will be questioned about headache, weakness, numbness or~          sleepiness. The electrode will be left in place for muscimol infusion (see #3).~        3. Muscimol infusion - Into the seizure focus, patients will be given two infusions-one of~          saline (salt water) alone and one of muscimol diluted in saline. Each infusion will be~          given over a period of one-half to 5 1/2 days, infused at the rate of 0.1 ml (1/50th of~          a teaspoon) per hour. During the infusions video-EEG recordings will continue and~          patients will be interviewed and examined as described in #2 above).~        4. Blood testing - About 2 tablespoons of blood will be drawn daily during the testing~          period and for the first 2 days after surgery (see #5).~        5. Surgery - Temporal lobectomy or topectomy (removal of a small, specific area of brain~          tissue) is the standard surgical treatment for medically intractable epilepsy whose~          seizure focus is not in a critical brain region, such as an area that controls language,~          movement, or sensation. If the patient's seizures arise from one of these areas, an~          alternative procedure called multiple subpial transection will be offered. In this~          procedure, vertical cuts are made in the seizure focus to prevent neurons (nerve cells~          that transmit electrical impulses) in the focus from spreading the seizure to the rest~          of the brain.~        6. Surgery follow-up - Patients will be monitored in the surgical intensive care unit for~          24 to 48 hours and then in the NINDS nursing unit for 4 to 8 days before being~          discharged to home. Another visit in the NINDS outpatient clinic will be scheduled for~          6-12 weeks after surgery.~   "
273582|NCT00005924|"~     This study will examine the effects of long-term antiviral therapy with valaciclovir~     (Valtrex) on Epstein-Barr virus infection. This virus infects more than 95 percent of people~     in the United States. Most are infected in childhood, have no symptoms, and are unaware of~     their infection. People infected as adolescents or adults may develop infectious~     mononucleosis, which usually resolves completely. Once infected, most people shed the virus~     from their throat occasionally, and all carry the virus in their white blood cells for life.~     This study will determine whether the amount of virus in the blood declines or disappears~     with long-term valaciclovir treatment.~      Normal volunteers who are not taking any antiviral medicines and patients enrolled in NIH's~     protocol no. 97-I-0168 (Evaluation of Valaciclovir for Prevention of Herpes Simplex Virus~     Transmission) or Glaxo-Wellcome protocol HS2AB 3009 at collaborating centers may be eligible~     for this study. Patients in the multi-center study must be about to start valaciclovir~     therapy for at least 1 year. All candidates must be 18 years of age or older.~      Study participants will be seen in clinic for about 1 hour every 3 months for a year. During~     these visits, they will provide information about the medicines they are taking, gargle twice~     with salt water and spit the fluid into a tube, and have blood drawn (no more than 8~     teaspoons each visit). The blood and gargled fluid will be tested for the amount of~     Epstein-Barr virus and antibodies to the virus. (Blood samples will also be tested for HLA~     type in order to do immunologic studies in the laboratory. HLA is a marker of the immune~     system that is similar to blood-typing testing.)~      The results in people taking valaciclovir will be compared with those in people not taking~     the drug. People whose results show the virus has disappeared from the body will continue to~     be followed twice a year for 5 years with the blood and gargling tests to continue to look~     for evidence of virus. Also, people who develop symptoms resembling mononucleosis (e.g.,~     enlarged lymph nodes with fever and sore throat) will be asked to have their blood tested for~     the virus.~   "
273583|NCT00005923|"~     The proposed research is an observational study designed to compare estrogen and progesterone~     serum levels with knee and ankle joint laxity, and muscle reaction time as a measure of~     neuromuscular function. Three groups of women athletes with differing estrogen and~     progesterone profiles (normal menstrual cycles, amenorrheic, and exogenous estrogen~     supplementation) and one control group (male collegiate athletes) will be used to compare~     differences in joint laxity and neuromuscular function. Blood levels of estrogen and~     progesterone will be measured at four time points across the menstrual cycle. Joint laxity~     and muscle reaction time will also be measured at each of these points. The investigator~     hypothesizes that knee and ankle joint laxity and muscle reaction time will significantly~     increase with increasing estrogen and progesterone levels.~   "
273584|NCT00005922|"~     This study uses the psychological principle known as classical conditioning to try to improve~     the standard treatment of psoriasis. Classical conditioning is a process of behavioral~     modification in which a person learns to connect a certain response-in this case, improvement~     of psoriasis-with a new action, or stimulus-in this case, application of an inactive cream.~     The goal of this study is to show that people with psoriasis who are maintained on~     corticosteroid cream part of the time and an inactive (placebo) cream at other times show a~     lower incidence of relapse and a reduced severity of psoriasis that patients treated with~     that same (reduced) amount of medication administered all the time.~   "
273585|NCT00005919|"~     The purpose of this study is to learn how pigment is released from the iris (the colored part~     of the eye) in patients with pigment dispersion syndrome. It will do this by examining the~     response of the pupil (the central opening of the iris) to a flash of light to determine what~     is happening in the iris to cause release of the pigment.~      In pigment dispersion syndrome, pigment released from the iris is deposited in other parts of~     the eye, including the trabecular meshwork-a filter-like tissue in the front of the eye.~     Aqueous fluid (fluid continuously produced by the eye) normally flows out of the eye through~     the trabecular meshwork. In some patients, the pigment deposits may block tiny holes in the~     meshwork, preventing the fluid from flowing out. This can cause an increase in eye pressure~     that may lead to glaucoma and some loss of vision. Understanding how pigment is released from~     the iris may help predict the course of pigment dispersion syndrome and identify which~     patients will likely develop increased eye pressure.~      Patients with pigment dispersion syndrome and normal volunteers may be eligible for this~     study. All participants will have the following procedures, which will be completed in two~     clinic visits:~      First visit~        1. Examination of the front of the eyes, including the cornea, iris and lens.~        2. Vision testing and measurements of visual field and eye pressure.~        3. Examination of the trabecular meshwork. For this test, a contact lens is placed on the~          eye after the eye has been numbed with anesthetic drops.~      Second visit~        1. Refraction (dilation of the pupils with drops) and examination of the back of the eyes,~          including the optic nerve.~        2. Reaction of the pupils to low-level infrared light (pupillography). During this~          15-minute test, the patient or volunteer wears a lightweight headband with two small~          cameras mounted on it. The cameras-one which views the eye and the other the subject's~          field of view-record pupil dilation and position.~      The test results in patients with pigment dispersion syndrome will be compared with those in~     normal volunteers. Patients will be followed every 6 months (or more often, if medically~     indicated) during the 3-year study to determine changes in eye pressure or visual field.~     Volunteers will be asked to return about once a year for 3 years for repeat pupillography.~   "
273600|NCT00005898|"~     OBJECTIVES: I. Determine the probability of engraftment with total body irradiation,~     cyclophosphamide, fludarabine, and anti-thymocyte globulin followed by HLA nongenotypically~     identical donor, T-cell depleted hematopoietic cell transplantation in patients with~     Fanconi's anemia.~      II. Determine the incidence of acute and chronic graft-versus-host disease in these patients~     after undergoing this treatment regimen.~      III. Determine the one-year survival rate in these patients after undergoing this treatment~     regimen.~      IV. Determine the toxicity of this treatment regimen in these patients. V. Determine the~     incidence of relapse in patients with myelodysplastic syndrome or acute myeloid leukemia~     after undergoing this treatment regimen.~   "
273673|NCT00005714|"~     To evaluate a community organization approach to promoting asthma management in four~     neighborhoods in St. Louis with predominantly low income, Black populations.~   "
273586|NCT00005917|"~     Chediak-Higashi syndrome (CHS) is a rare autosomal recessive disorder characterized in its~     classical form by oculocutaneous albinism, a bleeding diathesis, recurrent infection due to~     abnormal neutrophil and natural killer cell function, and eventual progression to a~     lymphohistiocytic infiltration known as the accelerated phase . Death often occurs within the~     first decade as a result of infection or the development of the accelerated phase; bone~     marrow transplantation is curative except for the late occurrence of neurological~     deterioration. The basic defect is unknown, although it probably involves abnormal fusion or~     trafficking of intracellular vesicles. Patients with classical CHS have their disease due to~     mutations in the LYST gene, but mildly affected individuals have been reported whose genetic~     defect has not been defined. It is likely that these variants of CHS have abnormalities in~     proteins involved in the pathways responsible for vesicle fusion. Since the full clinical~     spectrum of CHS and its variants has not been characterized, and the underlying defects~     remain enigmatic, we plan to evaluate this group of patients clinically, biochemically, and~     molecularly, and perform cell biological studies on their fibroblasts, melanocytes, and~     transformed lymphoblasts. Routine admissions will be 5 days and may occur every two years, or~     required by changes in clinical symptomatology.~   "
273587|NCT00005916|"~     This study will test the ability of an experimental vaccine to increase the number of~     tumor-fighting immune cells (lymphocytes) in patients with localized prostate cancer and~     prevent the disease from recurring following radiation therapy. The vaccine is intended to~     stimulate lymphocytes to target and attack cells containing a protein called prostate~     specific antigen, or PSA. It is composed of the following parts:~        -  rV-PSA: Vaccinia virus plus human DNA that produces PSA (prostate specific antigen)~        -  rV-B7.1: Vaccinia virus plus human DNA that produces B7.1 (a protein that helps guide~          immune cells to their targets)~        -  rF-PSA: Fowlpox virus plus human DNA that produces PSA~        -  GM-CSF: Drug that boosts the immune system.~        -  IL-2: Drug that boosts the immune system.~      Patients 18 years of age and older with prostate cancer confined to the prostate who have~     received a smallpox vaccine sometime in the past and who do not have a history of allergy to~     eggs may be eligible for this study. Candidates are screened with a complete medical history~     and physical examination, blood tests, and skin tests (similar to those for allergies or~     tuberculosis) to assess immune function.~      Participants are randomly assigned to receive one of the following three treatments: Group 1~     - standard radiation therapy plus the experimental vaccine; Group 2 - standard radiation~     therapy without the vaccine; Group 3 - standard radiation therapy with the vaccine, but with~     a different dose of IL-2 from Group 1.~      Patients in the vaccine groups receive injections in the arm or thigh in 28-day treatment~     cycles, as follows:~        -  GM-CSF: Days 1 through 4 of the first week~        -  IL-2 5: for Group 1, 5 days in the second week of each cycle; for Group 3, 14 days~          beginning in the second week of each cycle~        -  rV-PSA and rV-B7.1: Day 2 of the first cycle only~        -  rF-PSA (booster shots): Every 28 days, beginning day 2 of the second cycle (i.e., days~          30, 58, 86, etc.)~      Treatment continues for eight cycles unless serious side effects develop, PSA levels rise~     significantly, or the doctors feel there is no reason to continue therapy.~      All patients undergo radiation therapy and possibly hormone therapy, if indicated. Blood~     samples are drawn once a week for the first month and then once every 4 weeks to monitor~     safety. After treatment ends, patients are followed with examinations and blood tests every 3~     months for the first 2 years and then every 6 months until the doctors determine follow-up is~     no longer needed or the cancer returns.~      All patients have HLA tissue typing at the beginning of the study. Those who are type HLA-A2~     are asked to have additional procedures for studying the immune response that can be done~     only with this tissue type. This involves collecting blood samples before treatment begins,~     every 4 weeks during treatment, once after cycle 2, and once 4 months after the eighth~     vaccine. They also undergo four leukapheresis procedures for collecting white blood cells.~     For leukapheresis, blood is collected through a needle in an arm vein, similar to donating a~     unit of blood. The blood flows through a machine that separates it into its components. The~     white cells are removed, and the red cells, platelets and plasma are returned to the body,~     either through the same needle or through a needle in the other arm.~   "
273588|NCT00005914|"~     This nationwide study will create a DNA collection to permit qualified scientists to search~     for depression-related genes.~      More than 750 families with at least two siblings who have experienced major depression are~     needed for the study. Participants will be interviewed about psychiatric and family history,~     and will be asked to provide a small blood specimen. The identification of predisposing genes~     can lead to greater understanding of the brain mechanisms involved in severe depression which~     can in turn lead to the discovery of new treatments.~      A Certificate of Confidentiality from the federal government ensures that all information~     will be strictly confidential. Blood specimens are identified only by code number (not by~     name).~      Reimbursement is provided.~   "
273589|NCT00005911|"~     This study will assess the value of improved magnetic resonance imaging (MRI) techniques to~     study the lens of the human eye. Knowledge of how cataracts develop and progress has been~     hampered by the lack of human tissue available for study; MRI may provide an effective means~     for learning more about this eye disease.~      Normal volunteers between 18 and 70 years of age may be eligible for this study. Participants~     will undergo a medical history and complete eye examination, including vision assessment, eye~     pressure measurement, lens and retina examinations, and photography of the eye.~      MRI scans will be scheduled for a second visit. For this procedure, the volunteer's pupils~     are dilated and he or she then lies on a stretcher that is moved into a cylinder containing a~     magnetic field. A device similar to a welder's helmet is placed on the head. Attached to the~     device are an imaging probe and a small blinking light. The probe receives radio signals from~     the eye that a computer converts into images. During imaging, the participant gazes at the~     blinking light; this helps keep the eyes from blinking and wandering. Scan times vary from 2~     to 10 minutes; the total time for the study is less than an hour.~   "
273590|NCT00005910|"~     This study will determine if laparoscopy can be used successfully to find and remove~     insulinomas (insulin-secreting tumors of the pancreas). These tumors are very small and often~     difficult to locate with magnetic resonance imaging (MRI), computed tomography (CT) or~     ultrasound. Invasive procedures, such as arteriograms (X-ray imaging using a contrast agent~     injected into the bloodstream through a catheter) and venous sampling are more successful but~     involve more patient discomfort and greater risk. This study will test whether laparoscopy~     can be used to replace some or all of these tests, as well as more extensive surgery.~      Patients 11 years of age and older with low blood sugar (hypoglycemia) probably caused by an~     insulinoma may be eligible for this study. Candidates will have their hypoglycemia confirmed~     (with tests done under NIH protocol 91-DK-0066: Diagnosis and Treatment of Hypoglycemia) and~     will have CT imaging of the abdomen and MRI and ultrasound tests of the liver and pancreas.~     Patients whose tumors are not found by these studies will undergo arteriography of the~     pancreas and hepatic (liver) venous sampling.~      Patients will then have laparoscopy. This surgical procedure uses a laparoscope-a tube-like~     device with special cameras and an ultrasound probe attached through which the surgeon can~     see and operate inside the abdomen. Laparoscopy is commonly done to remove the gallbladder~     and is also used to remove portions of the pancreas. For the current procedure, the surgeon~     makes small incisions in the abdomen, inserts tubes, fills the abdomen with gas, and proceeds~     to explore and operate on the pancreas. The surgeon will try to locate the tumor with the~     laparoscope. If the tumor is found, the location will be verified by the imaging study~     results. If it cannot be located by laparoscopy, the results of the imaging studies will be~     disclosed to enable removal. If the tumor cannot be successfully removed using the~     laparoscope, standard surgery will then be performed. If the tumor cannot be found though~     laparoscopy, imaging studies, or traditional surgery, the operation will be concluded without~     removing any of the pancreas. Medical treatment will be initiated and re-evaluation will be~     recommended after 6 months.~   "
273591|NCT00005909|"~     The purpose of this study is to gain a better understanding of alkaptonuria and collect~     medical data on patients who may later participate in new drug trials for this rare genetic~     disease. In alkaptonuria, a pigment called homogentisic acid collects in bone and connective~     tissue, causing arthritis and eventually bone fractures, and also causes discoloration in the~     ears and whites of the eyes. Some patients also develop kidney stones and heart valve~     problems. Alkaptonuria has not been studied for decades; and scientists expect to gain~     comprehensive clinical information using current medical techniques.~      Patients with alkaptonuria who are at least one month old may be eligible for this study.~     Participants will be evaluated at NIH s Clinical Center for 5 days every 2 to 3 years. They~     will have a medical history, physical examination, routine blood and urine tests. Blood may~     also be collected to measure a type of collagen that indicates new bone formation and to~     analyze DNA for genetic studies. 24-hour urine collections will be done to measure organic~     acids and homogentisic acid excretion, assess overall kidney function, and evaluate bone~     metabolism. A total of 89.5 ml (about 6 tablespoons) of blood will be drawn for these studies~     in adults and 51 ml (about 3 tablespoons) in children.~      Patients will also have bone X-rays, kidney ultrasound, brain and chest computerized~     tomography (CT) scans, magnetic resonance imaging (MRI) scans of affected joints,~     electrocardiograms, echocardiogram, lung function tests, and a hearing test. Photographs of~     the face and full body (with underwear on) will be taken.~      Patients will also have consultations with dentistry and ophthalmology, with physical therapy~     and rehabilitation medicine for arthritis management, and with cardiology for heart valve~     evaluation. When appropriate, patients may also have dermatology, pulmonology and neurology~     consultations.~      The information from this study will enable doctors to better advise patients with~     alkaptonuria about their disease and treatment options. It will also prepare the way for~     clinical studies of a new drug that blocks production of homogentisic acid.~   "
273601|NCT00005896|"~     OBJECTIVES: I. Determine the safety of transferring the Fanconi anemia complementation group~     C (FACC) gene to hematopoietic progenitors by retroviral mediated gene transfer in patients~     with Fanconi's anemia, complementation group C.~      II. Determine the extent of engraftment following this treatment regimen without prior~     ablation of recipient marrow in these patients.~      III. Determine the ability of this treatment regimen to correct the cell phenotype and~     improve hematopoietic function in these patients.~   "
273602|NCT00005893|"~     OBJECTIVES: I. Determine the efficacy of bone marrow transplantation using matched related~     donors in patients with nonmalignant hematologic disorders.~      II. Determine the quality of life, absence of adverse effects (e.g., graft versus host~     disease and B cell lymphoproliferative disease), and completeness of recovery of their~     underlying condition in these patients with this treatment regimen.~   "
273592|NCT00005908|"~     This study will assess the usefulness of a technique called complementary deoxyribonucleic~     acid (cDNA) microarray-an examination of a wide array of genes to identify disease-associated~     patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study~     will look for markers that can help select the most effective type of chemotherapy. It will~     also evaluate the safety and effectiveness of a new drug combination of capecitabine and~     docetaxel.~      Patients age 18 years and older with stage II or III breast cancer whose tumor is 2~     centimeters or larger may be eligible for this study. Those enrolled will be treated with~     surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan),~     and the capecitabine and docetaxel combination.~      Patients will have a physical examination, mammogram and magnetic resonance imaging to~     evaluate their tumor before beginning treatment. They will then have four 21-day treatment~     cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on~     day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be~     given from days 16 through 21. This regimen will be repeated four times, after which the~     tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance~     imaging.~      Patients will then have surgery to remove the cancer-either lumpectomy with removal of the~     underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical~     mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a~     doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four~     21-day cycles.~      Some patients who had a mastectomy (depending on their tumor characteristics and whether~     tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also~     have radiation therapy. Patients with hormone receptor-positive tumors will also receive~     tamoxifen treatment for 5 years.~      In addition to the above procedures, all patients will have tumor biopsies (removal of a~     small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2,~     and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized~     tomography (CT) scans, electrocardiograms, multi-gated acquisition scan-MUGA (nuclear~     medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood~     tests at various times during the study. Patients will be followed at National Institutes of~     Health (NIH) for 3 years after diagnosis with physical examinations, blood tests, X-rays, and~     computed tomography (CT) scans.~      Although it is not known whether this treatment will help an individual patient's cancer,~     possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition,~     the information gained about genetic changes after chemotherapy will help determine if~     additional studies on the use of cDNA microarray to measure tumor response are warranted.~   "
273593|NCT00005907|"~     This study will compare the immune system response to booster vaccines for tetanus/diphtheria~     and hepatitis B in healthy volunteers with that of patients who have had a blood transplant.~     (A blood transplant is an infusion of donated stem cells-i.e., cells that mature into white~     blood cells, red blood cells and platelets). The study will also look at how age of the blood~     cell donor and recipient, the type of blood transplant, the amount of certain types of white~     cells in donor blood, and other variables may influence the vaccine response among the~     transplant patients.~      This study includes normal volunteers and patients who have had a blood transplant. Healthy~     volunteers between the ages of 18 and 60 who have previously been vaccinated with the~     hepatitis B or tetanus/diphtheria vaccine and have not had hepatitis B may be eligible for~     this study. Patients enrolled in a blood cell transplant study at NIH who are between 5 and~     60 years old, have been vaccinated against tetanus/diphtheria, and have not had hepatitis B~     may be eligible. Candidates will be screened with a medical history and blood tests.~      Those enrolled in the study will have about 2 tablespoons of blood drawn before vaccination~     with a standard tetanus/diphtheria booster shot. Volunteers who have previously been~     vaccinated with the hepatitis B vaccine and all blood transplant patients will also receive a~     hepatitis B vaccination. Participants will have blood drawn (from 1 to 5 tablespoons) up to~     once a week after vaccination for no more than 8 weeks to evaluate the immune response to~     vaccination.~   "
273594|NCT00005906|"~     Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is~     characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the~     LAM patient population is a subset of patients who develop chylous effusions and~     lymphangioleiomyomas. Treatment of many of these symptoms has been ineffective. Previous~     studies with somatostatin and octreotide in other clinical settings have shown reduction in~     chylous effusions. This study assesses the effectiveness of octreotide in symptomatic~     patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral~     lymphedema and chyluria.~   "
273595|NCT00005905|"~     This study will evaluate the safety and effectiveness of the leptin replacement therapy in~     treating lipoatrophy or lipodystrophy-a condition in which there is a total or partial loss~     of fat cells. Patients with lipodystrophy lack sufficient leptin, because this hormone is~     produced by fat cells. The leptin deficiency usually causes high blood lipid (fat) levels and~     insulin resistance that may lead to diabetes. Patients may have hormone imbalances, fertility~     problems, uncontrolled appetite, and liver disease due to fat accumulation.~      Patients 15 years and older with lipodystrophy are eligible for this study. Candidates are~     screened with a medical history and physical examination, and fasting blood tests. Those~     enrolled undergo the following additional procedures:~        -  Ultrasound of the liver and, if abnormalities are found, possibly a liver biopsy~        -  Resting metabolic rate measurement - measures the amount of oxygen breathed at rest in~          order to calculate how many calories are required to maintain resting body functions~        -  Magnetic resonance imaging of the liver and other organs, and of muscle and fat~        -  Estimation of body fat - measurements of height, weight, hip size, and skin folds over~          the arms and abdomen to estimate body fat content~        -  Insulin tolerance test - measures blood glucose levels after administration of insulin.~          Insulin is given through an intravenous (IV) catheter (a thin tube placed in a vein) and~          blood is drawn 5 minutes before the test begins, when the test begins, and 5, 10, 15, 20~          and 30 minutes into the test~        -  Oral glucose tolerance test - measures blood glucose and insulin levels after drinking a~          glucose (sugar) solution. Blood samples are drawn through an IV catheter 15 minutes~          before the test begins, at the time the test begins, and 30, 60, 90 and 180 minutes into~          the test~        -  Intravenous glucose tolerance test - measures tissue response to insulin and glucose~          after glucose is injected into a vein. The glucose injection is followed by a short~          infusion of insulin and then blood samples are taken over 3 hours to measure insulin and~          glucose levels~        -  Appetite level and food intake - measures hunger level and caloric intake. Patients are~          questioned about their hunger level, given a variety of foods they may choose to eat and~          questioned again at various intervals about hunger level. On another day, patients are~          given breakfast (usually a milkshake) and when they want to eat again, the appetite~          level and caloric intake study is repeated.~        -  Hormone function tests - the function of three hormones influenced by leptin~          (corticotropin-releasing hormone, thyrotropin-releasing hormone and luteinizing~          hormone-releasing hormone) are assessed. The hormones are injected intravenously and~          then blood samples are drawn.~      When all the tests are completed, leptin therapy begins. The drug is injected under the skin~     twice a day for 4 months by the patient or a caregiver (similar to self-administered insulin~     injections for diabetes). Blood is drawn once a month to monitor the effects of treatment and~     drug side effects. At clinic visits scheduled 1, 2 and 4 months after therapy starts,~     patients have a physical examination and meet with a dietitian. Medication dosage is also~     increased at these visits. At the end of 4 months, all baseline studies described above are~     repeated. Throughout the study, all patients complete a form once a week, in which they~     record their symptoms. Patients with diabetes also measure their blood glucose levels at home~     before each meal and at bedtime.~   "
273596|NCT00005903|"~     This study will examine the safety and effectiveness of an experimental drug called GDNF~     delivered through an investigational device to treat progressive supranuclear palsy (PSP).~     The drug will be administered directly into the brain through catheters attached to an~     infusion pump implanted in the abdomen. The study will evaluate 1) if the drug is safe and~     well tolerated when given by this method; 2) the performance of the catheters and pump~     system, and 3) the effects of GDNF on PSP symptoms.~      PSP is a rare neurological disease that causes eye movement dysfunction, muscle rigidity,~     slowness of movement, swallowing, speech, emotional, cognitive and personality problems.~     Patients 35 to 75 years old with PSP may be eligible for this study. Candidates will be~     screened at the National Institutes of Health outpatient clinic in Bethesda, MD, with a~     medical history, physical examination, neurological and neuropsychiatric evaluations, blood~     tests, electrocardiogram, CT scan of the brain, and baseline studies including a special eye~     examination, evaluation of symptoms, lumbar puncture (spinal tap) and psychiatric interview.~      Patients enrolled in the study will undergo surgery to place two catheters into the brain and~     two infusion pumps under the skin in the upper abdomen. The surgery will be performed at~     Vanderbilt University Medical Center in Nashville, TN. It will be done under general~     anesthesia and will require a 3 day hospitalization. Within 24 hours after the surgery, a CT~     scan of the brain will be done to ensure the catheters are properly placed. Patients return~     to NIH two weeks after surgery for post-surgery examination and treatment initiation.~      All patients will receive continuous infusions of GNDF through one catheter and placebo (an~     inactive salt solution) through the other for 6 months. Half of the patients will receive~     placebo in the right side of the brain and GNDF in the left, and half will receive GNDF in~     the right side of the brain and placebo in the left. All patients will also undergo the~     following procedures:~      Brief physical examination, and evaluation of symptoms and adverse side effects - every 2~     weeks~      Blood and urine tests - every 2 weeks for the first 2 months and then every 8 weeks until the~     end of the study~      CT scan to check catheter placement - weeks 9 and 27~      Thorough evaluation of symptoms - before beginning treatment and weeks 1, 5, 9, 17 and 27~      Neuropsychiatric evaluation - week 27~      Special eye examination - weeks 1 and 27~      Lumbar puncture - week 27~      Additional blood tests to measure drug concentration and antibodies - 6 times during the~     study~      In addition, some patients may be asked to have positron emission tomography (PET) scans or a~     single photon emission tomography (SPECT) scan, or both.~      The potential benefit of GDNF is unknown. In studies with rats and monkeys, GNDF increased~     the number and size of brain cells containing the chemical messenger dopamine and some~     movement and balance problems were lessened. Earlier studies of GDNF infused into the~     ventricles of patients with Parkinson's disease showed no benefit and no serious harm.~   "
273597|NCT00005902|"~     The purpose of this study is to learn more about the growth of brain and spinal cord tumors~     and cysts that develop in association with them in patients with von Hippel-Lindau disease.~     It will examine how fast the tumors grow and try to determine what factors (for example,~     puberty , pregnancy, menopause, blood proteins, etc.) affect their growth.~      Patients between the ages of 8 and 75 years who are enrolled in NIH s study of von~     Hippel-Lindau disease may be eligible for this 5-year study. Participants will have magnetic~     resonance imaging (MRI) of the brain and spinal cord and a thorough neurological history and~     examination at the start of the study. A blood sample will be taken for analysis of factors~     (hormones or other proteins) that may predict tumor growth. Follow-up clinic visits every 6~     months will include a physical and neurological examination, blood tests, and MRI scans of~     the brain and spine. If symptoms or tumor growth requires more frequent follow-up, scans will~     be done at 3-month intervals.~      Surgical removal of brain and spinal cord tumors is currently the treatment of choice when~     these lesions cause neurological problems. A better understanding of which tumors are likely~     to grow and which will remain stable may help guide physicians in treatment decisions and~     avoid unnecessary procedures.~   "
273598|NCT00005901|"~     This study will evaluate the effect of pamidronate a drug that decreases bone resorption~     (breakdown) on osteogenesis imperfecta. This is a genetic disorder of collagen, the major~     protein in bone. The abnormal collagen causes weak bones, and children with severe~     osteogenesis imperfecta sustain many fractures throughout their lives. They also have growth~     deficiency, curvature of the spine, crumbling teeth, hearing loss, easy bruising and heart~     and lung problems. The study will compare bone density, quality and strength, final adult~     height, trunk height, and functional ability in children who receive 1) pamidronate every 3~     months, 2) pamidronate every 3 months + growth hormone injections, 3) pamidronate every 6~     months, or 4) pamidronate every 6 months + growth hormone injections.~      Children 2 years of age and older with severe osteogenesis imperfecta (types III and IV) may~     be eligible for this study. Those enrolled will be randomly assigned to groups according to~     age; children two to four years of age will be randomly assigned to receive pamidronate every~     3 or every 6 months. Children four years of age and older may participate in the growth~     hormone treatment groups. These children will continue on growth hormone until they reach~     their adult height or fail to grow as much as would be expected for someone on growth~     hormone.~      Patients will be followed in the clinic every 3 months for a history, physical examination,~     X-rays, blood tests, and measurements (weight, head circumference, and bone lengths).~     Children will receive a 3 to 4 hour infusion of pamidronate through an intravenous catheter~     (thin flexible tube placed in a vein) once a day for 3 days each visit. (Once inserted, the~     catheter is left in place to avoid multiple needle sticks for administering the drug and~     collecting blood samples.) Children who are taking growth hormone will be given the drug at~     the first treatment visit. At that time, the accompanying parent will be instructed on how to~     mix the drug and give injections. The child receives an injection 6 days a week (Sunday off).~   "
273603|NCT00005892|"~     OBJECTIVES:~      I. Determine the effectiveness of moderate dose cyclophosphamide and radiotherapy in terms of~     improving survival and reducing the morbidity following allogeneic bone marrow~     transplantation in patients with myelodysplastic syndrome and acute leukemia related to~     Fanconi's anemia.~   "
273606|NCT00005889|"~     RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels.~     Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of~     amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar~     levels is not yet known.~      PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids,~     fat, and sugar given by intravenous infusion, and the effect of different combinations of~     nutrients on the infants' ability to maintain normal blood sugar levels.~   "
273607|NCT00005888|"~     OBJECTIVES: I. Compare the incidence of late onset sepsis and/or necrotizing enterocolitis~     and duration of hospitalization in low birth weight infants fed with fortified mother's milk~     supplemented with either fortified pasteurized donor human milk or preterm formula, and with~     fortified mother's milk versus preterm formula.~      II. Determine the relationship between functional antibody titers in serial milk samples and~     the incidence of pathogen specific late onset sepsis (e.g., Staphylococcus epidermidis,~     Staphylococcus aureus) in these patients.~      III. Determine the long term sequelae (growth, body composition, health, and~     neurodevelopment) of human milk versus formula feeding in these patients.~      IV. Determine the relationship between stress and milk production in the mothers of these~     patients.~   "
273608|NCT00005785|"~     This study will investigate the safety and effectiveness of a new stem cell transplant~     procedure to treat acute or chronic leukemia, multiple myeloma, myelodysplastic syndrome,~     Hodgkin's and non-Hodgkin's lymphoma in HIV-infected patients.~      HIV-infected patients usually are not offered bone marrow transplant treatments because they~     are at increased risk of dying from the intense chemotherapy and radiation therapy used for~     the procedure. This study uses a modified procedure, transplanting stem cells instead of bone~     marrow, designed to be less dangerous for such patients. Patients will also undergo a~     procedure called gene transfer to try to halt progression of their HIV infection. The~     procedure in this study differs from standard bone marrow transplantation in three ways:~      Stem cells will be transplanted instead of bone marrow. (Stem cells, which are produced by~     the bone marrow, mature into the different blood components-white and red cells and~     platelets.) The stem cell donor will be given a drug that releases these cells from their~     bone marrow into the blood stream. The cells will then be collected from the donor by~     apheresis, a procedure in which whole blood is drawn, the stem cells separated and removed,~     and the rest of the blood returned to the donor.);~      The procedure will use lower doses of chemotherapy than the conventional method, and will not~     use radiation therapy; or~      A laboratory-manufactured gene designed to obstruct HIV reproduction will be inserted into~     the stem cells, rendering future cells that develop from resistance to the virus.~      Prospective patients will be tested for matching with an HIV-negative donor (family member)~     and will undergo a medical history, physical examination and several tests (e.g., breathing~     tests, X-rays, etc.) to determine eligibility for the study. Study participants will then~     undergo apheresis to collect white blood cells called lymphocytes. Stem cells will be~     collected from the donor. Half the donated cells will have the HIV-resistant gene inserted;~     the other half will have a control gene inserted. Additional stem cells collected a second~     day will not be manipulated. All the donor cells will be frozen until transplantation.~      Patients will be given drugs (cyclophosphamide, fludarabine and cyclosporin) to prevent the~     donated cells from being rejected and to prevent them from damaging the patient's organs. The~     thawed stem cells will then be infused through a vein. After 30, 60 and 100 days, bone marrow~     cells and circulating lymphocytes will be checked to see how many are of donor cell origin.~     If less than 100 percent are of donor origin, more lymphocytes will be transfused. Patients~     will have physical examinations and blood tests once or twice a week for 2 to 3 months with~     and then will be followed periodically for at least 5 years.~   "
273609|NCT00005784|"~     This study offers evaluation and treatment for patients with certain diseases of the retina~     (the layer of light-sensitive tissue that lines the inside of the eyeball). The protocol is~     not designed to test new treatments; rather, patients will receive the current standard of~     care for his or her specific condition. The purpose of the study is twofold: 1) to allow~     National Eye Institute physicians to increase their knowledge of retinal eye diseases and~     identify possible new avenues of research in this area; and 2) to establish a pool of~     patients who may be eligible for new studies as they are developed. (Participants in this~     protocol will not be required to join a new study; the decision will be voluntary.)~      Patients with diabetic retinopathy, age-related macular degeneration, vascular occlusive~     disease, central serous retinopathy or another retinal disease may be eligible for this~     study. Candidates will be screened with a medical history, brief physical examination,~     thorough eye examination and blood test. The eye examination includes measurements of eye~     pressure and visual acuity (ability to see the vision chart), examination of the pupils and~     eye movements, and dilation of the pupils to examine the lens and retina. Patients will also~     undergo fundus photography and fluorescein angiography, as follows:~        -  Fundus photography - Special photographs of the inside of the eye to help evaluate the~          status of the retina and evaluate changes that may occur in the future. From 2 to 20~          pictures may be taken, depending on the eye condition. The camera flashes a bright light~          into the eye for each picture.~        -  Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye~          injected into an arm vein travels to the blood vessels in the eyes. Pictures of the~          retina are taken using a camera that flashes a blue light into the eye. The pictures~          show if any dye has leaked from the vessels into the retina, indicating possible blood~          vessel abnormality.~      Participants will be followed at least 3 years. Follow-up visits are scheduled according to~     the standard of care for the individual patient's eye problem. It is estimated that most~     patients will have from one to four follow-up visits each year. Vision will be checked at~     each visit, and some of the screening tests described above may be repeated to follow the~     progress of disease and evaluate the response to treatment.~   "
273610|NCT00005782|"~     This study will examine the effects of granulocyte colony-stimulating factor (G-CSF) on bone~     marrow stem cells in healthy volunteers with sickle cell trait and determine if cells~     collected for transplantation from donors with sickle cell trait require special handling.~      Stem cells, which the bone marrow produces, are responsible for making all the different~     kinds of blood cells. They are the cells used in bone marrow, or stem cell, transplantation.~     The drug G-CSF, which is a naturally occurring hormone, causes stem cells to mobilize-that~     is, to be released from the bone marrow and enter the blood stream. This drug is given to~     stem cell donors to increase the amount of cells that can be collected. Stem cell donors for~     patients with sickle cell disease are often healthy siblings of the patient who have a~     matching bone marrow type. Some siblings carry the sickle cell trait, however, and, even~     though they do not have sickle cell disease and their blood and bone marrow are normal, it is~     not known how their cells will react to G-CSF stimulation. Nor is it known if their stem~     cells require special methods of removal, processing or storing.~      Healthy volunteers 18 years or older with sickle cell trait who have no history of sickle~     cell disease and no known medical problems may be eligible for this study. Participants will~     have a medical history and physical examination, including blood tests and urinalysis. They~     will receive injections of G-CSF under the skin once a day for 5 days. On the fifth day, stem~     cells will be collected through leukapheresis. In this procedure, whole blood is drawn from~     an arm vein, similar to donating whole blood. The blood then circulates through a cell~     separator machine, the stem cells are removed, and the rest of the blood is transfused back~     to the donor through a vein in the other arm.~      The information gained from this study will be used to ensure the safety of stem cell donors~     with sickle cell trait and to better prepare stem cells for transplantation in sickle cell~     patients.~   "
273626|NCT00005761|"~     This study will determine whether certain factors in the blood are associated with the~     severity of diabetic retinopathy.~      Patients age 10 years and older with diabetes mellitus and diabetic retinopathy may be~     eligible for this study. Those enrolled will represent a range of diabetic retinopathy from~     minimal to severe. Participants will undergo the following procedures:~        -  medical history~        -  thorough eye examination~        -  photographs of the eye~        -  blood tests to measure blood lipids (cholesterol and triglycerides) and serum creatinine~          (for kidney function)~        -  blood tests to measure levels of blood factors (cell adhesion molecules, chemokines and~          vascular endothelial growth factor) that may be related to the progression of diabetic~          retinopathy~        -  blood pressure measurement~        -  urinalysis~      This study may lead to a better understanding of how diabetic retinopathy develops and~     progresses.~   "
273627|NCT00005760|"~     This study is for women who have already decided to undergo liposuction at Georgetown~     University Medical Center in Washington, D.C. To take part in this study, a woman must first~     meet with the plastic surgeons there, and be accepted by them to have liposuction. This study~     will investigate whether large volume liposuction improves risk factors for heart disease in~     overweight women with type 2 (adult onset) diabetes, impaired glucose tolerance, or elevated~     blood insulin levels. Large volume liposuction is the surgical removal of at least 10 pounds~     (4.5 kg) of body fat, usually from the abdomen, hips or chest. Risk factors for heart disease~     include high blood pressure and elevated levels of blood lipids (cholesterol and~     triglycerides), blood glucose (sugar), and blood insulin. Subjects who participate in all~     parts of this study will receive a total of $930.00.~      Overweight women 18 years or older with high blood insulin levels, impaired glucose~     tolerance, or type 2 diabetes, who are planning to have large volume liposuction performed at~     Georgetown University Medical Center in Washington, D.C., may be eligible for this study. For~     a subject to be accepted into this study, she must first meet with the plastic surgeons at~     Georgetown University Medical Center, and they have to agree to perform large volume~     liposuction. The decision that someone is suitable for liposuction is not under the control~     of the NIH or of any NIH investigator.~      Those enrolled will undergo the following procedures at four separate times - before~     undergoing liposuction, 4 weeks after surgery, 4 months after surgery and 1 year after~     surgery:~        -  Body measurements - taken with calipers to measure several skinfold thicknesses (the~          width of a fat fold) and with a tape measure to measure the circumference of parts of~          the body.~        -  Urine sample and 6-hour urine collection - to test for pregnancy and to evaluate kidney~          function.~        -  Glucose tolerance test - measures insulin sensitivity and how the body uses sugar, how~          well insulin works, and insulin sensitivity. The procedure involves placement of two~          catheters (thin, flexible tubes) through a needle into a vein in each arm. Sugar water~          is infused into one catheter and 20 minutes into the test a small amount of insulin is~          injected. Blood samples are drawn from the other catheter at frequent intervals for a~          total of 5 hours.~        -  Electrocardiogram (ECG) and echocardiography - measure the heart's electrical activity~          and function.~        -  Abdominal computerized tomography (CT) scan - produces images for measuring body fat in~          the abdomen. (not done at the 4-week visit). Takes about half an hour to complete.~        -  DXA X-ray - measures body fat, muscle and bone mineral content. Takes about half an hour~          to complete.~        -  Bod Pod - capsule-like device used to determine the proportion of body weight composed~          of fat and non-fat tissue. Takes less than 10 minutes~        -  Bioelectric impedance analysis device - measures the proportions of body fat based on~          electrical conduction of a small electric current. Takes 2-3 minutes.~        -  24-hour blood pressure monitoring - a device attached to a blood pressure cuff strapped~          to the arm measures blood pressure every 15 to 30 minutes continuously for 24 hours.~        -  Vascular reactivity tests - a blood pressure cuff is inflated for about 4 minutes before~          deflating, providing information on the function of the small blood vessels in the skin,~          as well as an idea of the function level of small blood vessels elsewhere in the body.~          Takes half an hour.~        -  Blood samples - collected to evaluate kidney and liver function and to measure body~          lipids, such as cholesterol, minerals, and other substances.~   "
273628|NCT00005675|"~     Diffuse systemic sclerosis (SSc), or scleroderma, is a connective tissue disease causing~     damage to skin and other organs. The purpose of this study is to determine if taking oral~     bovine type I collagen (CI) will improve the condition of SSc patients.~   "
273611|NCT00005780|"~     This study will evaluate the safety and effectiveness of an experimental cancer vaccine for~     mantle cell lymphoma a form of cancer of the white blood cells called lymphocytes. Although~     standard treatments for lymphoma may achieve disease remission, none provides a cure.~      Patients with mantle cell lymphoma 18 years and older who have not been treated previously~     with chemotherapy may participate in this study. Candidates will be screened for eligibility~     with a medical history and physical examination. Other tests that may be required include~     blood and urine tests; lung function studies; imaging tests such as magnetic resonance~     imaging, computed tomography and X-rays; and biopsy (surgical removal of a small tissue~     sample) of tumor, bone marrow, or other tissue.~      Patients enrolled in the study will begin treatment with chemotherapy designed to reduce~     disease to a minimum that is, to achieve remission or shrink the tumor as much as possible.~     Chemotherapy will be administered on an outpatient basis over a period of around 12 to 18~     weeks in 3-week cycles as follows: prednisone by mouth on days 1 through 5; etoposide,~     doxorubicin and vincristine intravenously through (a vein) on days 1 through 5; and~     cyclophosphamide intravenously on day 5. Starting day 6, patients receive no chemotherapy for~     16 days. In addition, an antibody called rituximab, which attaches to lymphoma cells and may~     increase the effectiveness of the chemotherapy, will be given on day 1 of the cycle. Patients~     will also receive a protein called G-CSF starting day 6 of the cycle and continuing until the~     white blood cell count recovers or until day 19. G-CSF is naturally produced by bone marrow~     and may boost the immune system. The chemotherapy drugs and rituximab are infused through a~     vein by means of a lightweight portable pump, which patients are taught how to use. Patients~     are also how taught how to give themselves G-CSF injections under the skin, similar to~     insulin injections.~      The first vaccination will be given at least 3 months after chemotherapy ends and will be~     repeated every 4 weeks for a maximum of 5 vaccinations. The vaccinations will be given in the~     clinic. Patients will also receive daily injections of GM-CSF, a growth factor naturally~     produced by bone marrow that can boost the immune system. These injections will be given the~     day of the vaccination and for the next 3 days.~      When vaccine therapy is completed, patients who were treated successfully will be followed~     with periodic clinic visits for follow-up examinations and tests. Patients in whom the~     lymphoma did not disappear entirely or who have a recurrence of disease will be advised of~     further treatment possibilities.~   "
273612|NCT00005778|"~     This study compares the effectiveness of high-dose cyclophosphamide treatment with the gold~     standard treatment, monthly intravenous (IV) cyclophosphamide, in people with moderate to~     severe lupus that does not respond to high-dose corticosteroid therapy. We will give patients~     either IV cyclophosphamide (750 milligrams per square meter of body surface area) monthly for~     6 months, followed by quarterly maintenance therapy, or high-dose IV cyclophosphamide (50~     milligrams per kilogram body weight per day) for the first four days of the study. Patients~     will be followed for 24 months after therapy.~   "
273613|NCT00005777|"~     This multicenter clinical trial tested whether minimal ventilation decreases death or BPD.~     Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were~     randomly assigned to minimal ventilation (partial pressure of carbon dioxide [PCO(2)] target~     >52 mm Hg) or routine ventilation (PCO(2) target <48 mm Hg) and a tapered dexamethasone~     course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was~     death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were~     recorded for 10 days; complications and outcomes were monitored to discharge. The infants'~     neurodevelopment was evaluated at 18-22 months corrected age.~   "
273614|NCT00005776|"~     Respiratory failure in term newborns is associated with increased rates of death and~     long-term neurodevelopmental problems. This large international multicenter trial randomized~     newborns who had failed to respond to intensive care, including high levels of ventilator~     support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether~     iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were~     followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of~     age.~   "
273615|NCT00005775|"~     This large multicenter double-masked clinical trial tested whether supplementation of~     standard neonatal parenteral nutrition with glutamine would reduce the risk of death or~     late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm)~     infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or~     TrophAmine supplemented with glutamine before 72 hours and continued until the infants are~     tolerating full enteral feedings.~   "
273616|NCT00005774|"~     Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is~     associated with lung injury and nosocomial infection. Moderately premature infants with mild~     respiratory distress do not routinely receive artificial surfactant early in their course of~     treatment. This multi-center, randomized trial tested whether early surfactant therapy and~     nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced~     mechanical ventilation usage without added complications. Infants with mild to moderate~     respiratory distress syndrome were enrolled in the trial and given either early~     administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or~     standard practice (surfactant according to current center practice, only after initiation of~     mechanical ventilation), to see whether the experimental method would reduce the need for~     subsequent mechanical ventilation.~   "
273617|NCT00005773|"~     This prospective, randomized controlled trial tested whether initiating iNO therapy earlier~     would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) --~     temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants~     who were born at >34 weeks' gestation were enrolled when they required assisted ventilation~     and had an oxygenation index (OI) >15 and <25 on any 2 measurements in a 12-hour interval.~     Infants were randomized to receive either early iNO or to simulated initiation of iNO~     (control). Infants who had an increase in OI to 25 or more were given iNO as standard~     therapy. The neurodevelopment of the subjects were evaluated at 18-22 months corrected age.~   "
273618|NCT00005772|"~     This large multicenter trial tested whether cerebral cooling initiated within 6 hours of~     birth and continued for 72 hours would reduce the risk of death and moderate to severe~     neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation~     with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event~     and a 10-min Apgar score <5, or continued need for ventilation were screened. Following a~     neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour~     period of total body cooling (cooling blanket, followed by slow re-warming). The study was~     conducted in two phases: Phase I (20 infants) were examined for the safety of an esophageal~     temperature of 34-35 C; Phase II (main trial, 200 infants) were evaluated for the safety and~     efficacy of an esophageal temperature of 33-34 C. Cardio-respiratory, electroencephalograms~     (EEGs), renal, metabolic, and hematologic status, and esophageal and abdominal skin~     temperature were monitored during the 72 hours of intervention. Surviving children were given~     neurodevelopmental examinations at 18-22 months corrected age and again at school age (6-7~     years of age).~   "
273651|NCT00005736|"~     To design, develop, implement, and test the effectiveness of a three component health~     services and health education intervention for primarily Hispanic inner-city elementary~     school students at high risk for asthma morbidity and mortality.~   "
273619|NCT00005771|"~     Recently, physical therapists have begun treating people who have mechanical low back pain,~     hypothesized to be caused by segmental instability in the lumbar spine, with a very specific~     exercise program consisting of trunk stabilization exercises. The theory behind the use of~     trunk stabilization exercises to treat lower back pain is that active contraction of the~     trunk local segmental muscles helps to control inter-segmental movement in the spine. The~     initial trunk stabilization exercise that physical therapists teach patients is an abdominal~     drawing in maneuver often called an abdominal hollowing exercise (AHE). A challenge for~     physical therapists is to establish the most effective means of teaching people to contract~     the relevant muscles needed to perform the AHE. The purpose of this study is to examine if~     supplementing the typical clinical instruction for teaching the AHE with visual ultrasound~     feedback to the patient is effective at reducing the length of time it takes an individual to~     learn to perform an AHE.~      Three groups of research volunteers will be taught how to do the AHE while receiving~     different kinds of feedback about their performance in order to determine which type of~     feedback is most effective in assisting people to learn the AHE. Group 1 will not receive any~     feedback about performance; Group 2 will receive feedback from palpation and verbal~     descriptive alone; and Group 3 will receive feedback from palpation, verbal descriptive~     feedback, and real time ultrasound. For the initial test when subjects are learning the AHE,~     the number of trials until the subject demonstrates his/her third correct AHE will be the~     outcome variable. For the retention test, the outcome variable will be the percentage of~     trials (out of ten) of correctly performed AHEs in the absence of visual, verbal or palpation~     feedback.~   "
273620|NCT00005770|"~     During acupuncture treatment, acupuncture needles are inserted and manipulated until a~     characteristic local tissue reaction termed de qi is observed. De qi can be perceived by~     the acupuncturist in the form of needle grasp, a mechanical gripping of the needle by the~     tissue. De qi is considered essential to the therapeutic effect of acupuncture. Therefore,~     the investigator proposes that understanding this local tissue reaction will lead to an~     understanding of how the therapeutic effect of acupuncture therapy arises. Specifically, it~     is hypothesized that needle manipulation causes winding of collagen and elastic fibers around~     the needle. This action induces tension in the collagen network surrounding the needling site~     and results in a mechanical signal that is transduced into local cells. The objective of the~     current work is to use ultrasound elastography, a recently developed ultrasound imaging~     technique, to visualize and quantify changes in the elastic properties of skin and~     subcutaneous tissue in 12 healthy human volunteers as a result of acupuncture needle~     manipulation.~   "
273621|NCT00005769|"~     Considerable controversy exists regarding the effect of estrogen and progesterone on insulin~     sensitivity in postmenopausal women. Thus, the goal is to examine the effect of estradiol and~     progestin on in vivo insulin sensitivity and pathways of intracellular glucose metabolism in~     postmenopausal women. This will be accomplished by examining the effects of unopposed~     estrogen (CEE) or combination estrogen and progestin (CEE/MPA) versus placebo therapy in 30~     early menopausal women (defined from 6 months to 3 years post-cessation of menses). Women~     will be treated for 16 weeks and the outcome measures will be: 1) insulin sensitivity and~     glucose oxidation as determined by euglycemic clamp, 2) assessments of insulin sensitivity on~     muscle biopsy cultures with the primary endpoints being glucose uptake and glycogen~     accumulation/synthesis, 3) protein levels of insulin action cascade steps based on muscle~     biopsy Western blots.~   "
273622|NCT00005768|"~     This study will examine whether estrogen administration in postmenopausal women can alter the~     response to changes in brain chemistry brought about by dietary manipulation. Women who are~     recently menopausal (50-60 yrs. of age) and over 20 years postmenopausal (>70 yrs. of age)~     will take estrogen or placebo for three months. At the end of that time they will participate~     in three challenges using dietary techniques to briefly change the relative amounts of~     neurotransmitters in the brain that are believed to be related to mood regulation (serotonin,~     dopamine, and norepinephrine). Previous research has shown that these dietary manipulations~     can briefly produce negative changes in mood. The investigator hypothesizes that estrogen~     administration will blunt or buffer these negative effects in a quantifiable way. The~     investigator believes that this will provide a direct test of the ability of estrogen to~     meaningfully change the brain chemistry of mood in a clinically measurable and positive way.~     The proposed procedure will also allow assessment of the effects of estrogen on brain~     neurotransmitter systems after many years of very low estrogen levels.~   "
273623|NCT00005767|"~     This protocol seeks to define aspects of intestinal and hepatic uptake and metabolism of~     several amino acids. The major hypothesis to be tested is that the splanchic bed (intestine~     and liver) conserves essential amino acids and metabolites while synthesizing and~     metabolizing nonessential amino acids. The aims of the study include defining the relative~     roles of enteral and hepatic extraction/metabolism in the disposition of glutamate, alanine,~     methionine and other amino acids. Emphasis will also be placed on studies of the~     transamination of alpha-ketoisocaproic acid (KIC) to leucine since this reaction is of~     potential importance in the design of nutritional regimens for patients with renal disease.~   "
273624|NCT00005766|"~     The objective of this study is to determine whether creatine slows disease progression in~     subjects with amyotrophic lateral sclerosis (ALS). ALS is a progressive uniformly lethal~     neurodegenerative disorder for which there is no known cure. Recent genetic and biochemical~     studies implicate free radical toxicity, glutamate excitotoxicity and mitochondrial~     dysfunction as possible causes of familial ALS (FALS) and sporadic ALS (SALS). It has been~     hypothesized that in ALS there may be involvement of oxidative free radical damage and~     impaired mitochondrial energy metabolism that could in turn lead to excitotoxic cell death.~     Creatine, an agent that improves mitochondrial function, has been shown to be neuroprotective~     in animal models of ALS and Huntington's disease.~      This study is a double-blind, randomized, placebo-controlled trial of the safety and efficacy~     of creatine in patients with ALS enrolled at sites distributed throughout the United States,~     including Northeast ALS (NEALS) sites. The study will provide preliminary data on the safety~     and efficacy of creatine in ALS. If creatine slows disease progression in ALS and is well~     tolerated, a phase 3 study with survival as the primary outcome measure will be initiated.~      114 eligible subjects will be randomized to receive treatment for 6 months of (1) active~     creatine or (2) placebo. After randomization, subjects will be followed prospectively for 6~     months. The primary outcome measure for the study is the change in upper extremity motor~     function after 6 months of experimental therapy as tested with the Tufts Quantitative~     Neuromuscular Exam. Strength in eight arm muscles will be measured (bilateral shoulder and~     elbow flexion and extension). Secondary outcome measures include grip strength, motor unit~     number estimates (MUNE), the ALS functional rating score-revised (ALSFRS-R), and rate of~     change of a well established biochemical marker of oxidative damage to DNA (8OH2'dG levels in~     urine), and the safety and tolerability of creatine.~   "
273629|NCT00005674|"~     The purpose of this study is to evaluate the safety and effectiveness of creatine treatment~     in amyotrophic lateral sclerosis (ALS). There is currently no known effective treatment for~     ALS. It is known that nerve cells die in the brains and spinal cords of patients with ALS but~     the cause of the cell death is unknown. It has been shown that there is overactive nerve~     activity due to increased levels of a chemical called glutamate and that there is abnormal~     cellular metabolism along with increased production of substance called free radicals.~     Improving cellular metabolism and readjusting the activity of glutamate in the brain may be~     beneficial to ALS patients.~      Creatine is a naturally occurring compound, which improves energy metabolism in cells.~     Creatine has been given to patients with energy metabolism defects in their muscles, and to~     athletes. Creatine improves survival in a mouse model of ALS. Three human subjects with ALS~     have received creatine for up to six months without any side effects. Overall, creatine has~     been well tolerated and safe.~   "
273630|NCT00005763|"~     To coordinate an international study on the relationships between population mean sodium and~     potassium intake and blood pressure.~   "
273631|NCT00005757|"~     To determine whether differences in the activity of the renin-angiotensin and bradykinin~     systems are involved in the pathogenesis of blood pressure variation in African Americans.~   "
273632|NCT00005756|"~     To investigate the prevalence and prognostic value of subclinical atherosclerosis in the~     Pittsburgh SHEP cohort and a cohort of normal controls.~   "
273633|NCT00005755|"~     To examine the occupations, industries and exposures in the work-place which were associated~     with a high risk for asthma and other adverse respiratory health effects, with particular~     emphasis on specific exposures of predominantly female occupations (irritants, detergents and~     other asthmagens), and of other high risk major occupations which had not been adequately~     examined.~   "
273634|NCT00005754|"~     To investigate the occurrence and associated risk factors for subclinical heart disease in~     persons with insulin-dependent diabetes mellitus (IDDM).~   "
273635|NCT00005753|"~     to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to~     reduce its impact on psychological functioning, health, and economic sequelae.~   "
273636|NCT00005752|"~     To examine the effects of ethnicity, socioeconomic status (SES) and behavior in overweight~     adults.~   "
273637|NCT00005751|"~     To determine whether the presence of endothelial dysfunction is an independent risk factor~     for cardiovascular disease events.~   "
273638|NCT00005750|"~     To conduct an integrated, multiple-component, school- and community-based intervention~     targeting both primary and secondary prevention of obesity among third-fourth-and~     fifth-graders (School- and Family-Based Obesity Prevention for Children).~   "
273639|NCT00005749|"~     To determine the differential effectiveness of a culturally tailored program to shape and~     maintain moderate intensity physical activity and to improve cardiorespiratory fitness among~     low SES sedentary Latino women.~   "
273640|NCT00005748|"~     To examine the role of Transcendental Meditation in stress reduction and prevention of~     hypertension in Blacks.~   "
273641|NCT00005746|"~     To test the effectiveness of a community site neighborhood health worker/nurse (NHW/N) case~     management strategy for coronary heart disease risk reduction compared with usual care in~     apparently healthy African American siblings of persons with documented premature coronary~     heart disease.~   "
273642|NCT00005745|"~     To quantify the association between multiple intentional weight losses (i.e., weight~     fluctuations) and the development of hypertension and diabetes mellitus among 50,790 female~     nurses participating in the ongoing Nurses' Health Study II. In addition to assessing the~     consequences of weight fluctuations, their correlates and course were identified.~   "
273643|NCT00005744|"~     To conduct a randomized demonstration and education trial of churches in East Baltimore~     testing a self-help, minimal intervention compared with an intensive physical activity~     intervention.~   "
273644|NCT00005743|"~     To develop intervention strategies that improve long-term exercise adherence in obese adults~     in in order to improve long-term weight loss.~   "
273645|NCT00005742|"~     To develop and test various educational strategies targeting primarily minority TB-infected~     adolescents at two health centers in Los Angeles in an experimental design to assess the~     relative effectiveness on medication adherence, appointment keeping, and completion of~     therapy.~   "
273646|NCT00005741|"~     The Community Outreach Intervention Project (COIP) implemented and evaluated a TB~     intervention with injection drug users (IDUs) in two Chicago Neighborhoods, guided by the~     indigenous outreach leadership model that had been used for AIDS prevention among drug users.~   "
273647|NCT00005740|"~     To develop a behavioral intervention aimed at public health workers who perform tuberculosis~     contact investigation and designed to enhance the contact investigation process.~   "
273648|NCT00005739|"~     To compare alternative methods to ensure completion of treatment and preventive therapy for~     tuberculosis (TB) in inner cities, and to identify the most cost-effective methods to~     accomplish that. The basis for comparison included adherence rates and cost savings as~     primary outcomes, and other parameters such as patient satisfaction, development of social~     networks, and participation in support programs as secondary outcomes.~      Two clinical trials were conducted with patients from Harlem. Among those with active~     disease, a clinic-based surrogate family model was compared to traditional community-based~     directly observed therapy (DOT). Among those eligible for preventive therapy, a~     community-based intervention conducted by trained graduates of a TB DOT program (peer~     workers) was compared to traditional self-administered preventive treatment.~   "
273649|NCT00005738|"~     To test a public health model of screening, preventive isoniazid treatment, and adherence~     counseling plus medical education of primary care clinicians to enhance their skills and~     attention to TB control. Also, to test a behavioral adherence intervention for Latino~     adolescents with latent disease and a medical education program designed to enhance primary~     care (community clinic) practitioners' treatment of active and latent TB infection.~   "
273650|NCT00005737|"~     To conduct a three-arm, randomized controlled trial of methods to improve adherence to~     biweekly directly observed prophylaxis (DOPT) for tuberculosis in homeless adults in San~     Francisco.~   "
273698|NCT00005689|"~     To provide a comprehensive description of smoking beliefs and behavior among rural Blacks,~     and to test the effectiveness of smoking cessation strategies delivered through Black~     churches.~   "
273674|NCT00005713|"~     To demonstrate that the New York City Department of Health Child Health Clinics could improve~     the health status of Black and Hispanic children with asthma by providing them with a~     comprehensive system of continuity of care that included pharmacologic treatment, family~     health education and community outreach.~      Recent studies have shown that lack of continuing primary care for asthma is associated with~     increased levels of morbidity in low-income minority children. Although effective preventive~     therapy is available, many African-American and Latino children receive episodic treatment~     for asthma that does not follow current guidelines for care. To see if access, continuity,~     and quality of care could be improved in pediatric clinics serving low-income children in New~     York City, we trained staff in New York City Bureau of Child Health clinics to provide~     continuing, preventive care for asthma.~   "
273675|NCT00005712|"~     To evaluate the effects of a new statewide program to enhance identification, referral and~     provision of care to rural families of Hispanic children with moderately severe to severe~     asthma. Specifically, to determine if comprehensive medical care (CMC) plus an educational~     self-management program for rural Hispanic children and their families had an impact on~     asthma morbidity, as well as on cost and family adaptation.~   "
273676|NCT00005711|"~     To design, implement, and evaluate an intervention program for Hispanic children with asthma~     which included both a physician education and a patient/family education component.~   "
273677|NCT00005710|"~     To develop and to test a brief telephone intervention following clinic treatment for smoking~     cessation.~   "
273678|NCT00005709|"~     To study relationships among lipoprotein metabolism, hypertension, and~     hyperinsulinemia-insulin resistance in African American males and females. The study was part~     of a Collaborative Project on Minority Health which investigated the mechanisms by which~     insulin contributes to cardiovascular disease.~   "
273679|NCT00005708|"~     To develop effective strategies for enhancing adherence to therapeutic interventions designed~     to improve care for hypertensive minority populations.~   "
273680|NCT00005707|"~     To improve long-term blood pressure BP) control in a predominantly African-American, low SES~     community of a large city.~   "
273681|NCT00005706|"~     To investigate whether a health education program, developed in partnership with the~     community and delivered by nurse supervised community health workers (CHWs), lowered high~     blood pressure (HBP) in inner city African American adults.~   "
273682|NCT00005705|"~     To evaluate three adherence promoting interventions within the Childhood Asthma Management~     Program (CAMP), an eight center clinical trial that compared pediatric asthma therapies in~     children five to twelve years old.~   "
273683|NCT00005704|"~     To test pharmacologic intervention for smoking postcessation weight gain using nicotine gum~     and phenylpropanolamine (PPA).~   "
273684|NCT00005703|"~     To assess in older children and adults with sickle cell disease (SCD) whether intrinsic~     activation (relevant to the origin of pain and acute inflammation) occurs only during~     vasocclusive crisis (VOC).~   "
273685|NCT00005702|"~     To experimentally test methods to promote long-term smoking cessation in hospitalized~     patients.~   "
273686|NCT00005701|"~     To conduct a series of five inter-related studies on acute cardiac ischemia (ACI) in women.~   "
273687|NCT00005700|"~     To conduct a randomized controlled trial to evaluate the effectiveness of an intervention to~     reduce dietary fat.~   "
273688|NCT00005699|"~     To conduct a community based education program using existing resources to improve~     hypertension control in the inner city through multiple interventions.~   "
273689|NCT00005698|"~     To implement and evaluate with a randomized, controlled trial interventions to improve~     control of hypertension among inner city low- income and minority residents of Seattle.~   "
273690|NCT00005697|"~     This 31-month supplement to Sustaining Women's Smoking Cessation Postpartum (Project PANDA)~     designed, implemented, and evaluated an intensified intervention for pregnant women who were~     unable to stop smoking with minimal assistance.~   "
273691|NCT00005696|"~     To complete end point analysis for the Monitored Atherosclerosis Regression Study (MARS) and~     to compare coronary versus carotid treatment effect relationships in MARS to coronary versus~     carotid treatment effect relationships in the Cholesterol Lowering Atherosclerosis Study~     (CLAS). Both MARS and CLAS were serial arterial imaging trials that explored the~     reversibility of atherosclerosis with lipid-lowering therapy in native coronary, carotid, and~     femoral arterial beds, as well as in coronary artery bypass grafts.~   "
273692|NCT00005695|"~     To determine the effects of physical activity on blood pressure and body fat in children~     varying in ethnicity, gender, and health status.~   "
273693|NCT00005694|"~     To study the relative effectiveness of teaching occupational nurses to conduct cholesterol~     screening, counseling and referral events (SCOREs) in their own worksites versus using an~     external organization to implement these programs. Also. to study the relative effectiveness~     of face-to-face behavior change counseling following the cholesterol measurement versus~     automated feedback of essentially the same individualized educational material.~   "
273694|NCT00005693|"~     To develop and evaluate a computer assisted instruction (CAI) weight management program in an~     adult population with low literacy at Sheehan Memorial Hospital's Family Care Center (FCC),~     an outpatient clinic serving the inner city of Buffalo, New York.~   "
273695|NCT00005692|"~     To determine inflammation markers over time in cardiovascular disease. To test the hypothesis~     that measures of coagulation and fibrinolysis correlate with the incidence of coronary heart~     disease (CHD) and other thrombosis related disorders, and to help identify those individuals~     at greatest risk, using the Cardiovascular Health Study (CHS) and Honolulu Heart Program~     (HHP) populations. These two genetically distinct populations had different event rates for~     CHD, and offered a unique opportunity to test associations that were uncovered by comparing~     results across populations.~   "
273696|NCT00005691|"~     To study psychosocial risk factors for coronary heart disease in Swedish women.~   "
273697|NCT00005690|"~     Among patients undergoing elective primary coronary artery bypass graft (CABG), the principal~     objective of this randomized trial was to compare the efficacy of two strategies of~     intra-operative hemodynamic management during cardiopulmonary bypass in preventing~     peri-operative cardiac, cognitive and neurologic morbidity and mortality, and post-operative~     deterioration in patients' quality of life as measured by the SF-36.~   "
273699|NCT00005688|"~     To investigate the differential diagnosis and longitudinal course of medical outpatients~     complaining of palpitations. Also, to further examine the process of cardiac perception, the~     psychological factors which influence it, and the accurate awareness of cardiac arrhythmias.~   "
273700|NCT00005687|"~     To study the process of recycling failed smoking cessation attempts and relapses.~   "
273701|NCT00005686|"~     To develop a dietary intervention method that was capable of producing large sustained weight~     losses and was thus suitable for use in clinical trials related to obesity.~   "
273702|NCT00005685|"~     To examine racial and psychosocial influences on blood pressure control.~   "
273703|NCT00005684|"~     To perform a randomized clinical trial comparing continuing one month of treatment with~     heparin in patients with deep venous thrombosis to standard care using heparin for five days~     and oral warfarin for three months.~   "
273704|NCT00005683|"~     To conduct clinical interventions directed at neonatal lung disease and injury, with a focus~     on infants having surfactant-deficiency or inactivation as a component of pathophysiology. A~     major emphasis was on the surfactant-deficient Respiratory Distress Syndrome (RDS) of~     premature infants, and on acute neonatal respiratory failure in term infants with pulmonary~     edema and potential surfactant inactivation (ARDS-related).~   "
273705|NCT00005682|"~     To conduct incidence and case-control studies of aplastic anemia in metropolitan Bangkok,~     Thailand~   "
273706|NCT00005681|"~     To test the hypothesis that the aggressive treatment of plasma LDL and oxidized LDL will~     result in improvements in the activity of ischemia in patients with coronary artery disease~     and will reverse characteristic cell/vessel wall dysfunctions in the arteries of these~     patients.~   "
273707|NCT00005680|"~     To examine the effect on health and disease of the work environment, psychological workload,~     control over work pacing and content, opportunity for use of skills, social support at work;~     the moderating effect on these relationships of social supports; and, the interaction between~     these psychosocial factors and other established risk factors in the etiology of chronic~     disease.~   "
273708|NCT00005679|"~     To conduct a multicenter prevalence survey for characterizing pathologically the extent of~     atherosclerosis in the aortas and coronary arteries of young persons dying from accidental~     causes, suicide, or homicide.~   "
273709|NCT00005678|"~     To foster collaboration between the World Health Organization MONICA Project and the NHLBI~     Study of Atherosclerosis Risk in Communities (ARIC). To ensure that valid comparisons could~     made between findings in MONICA and ARIC by supporting activities to standardize coding,~     classification, and analysis of coronary and stroke events, risk factors, and medical care~     according to MONICA protocol.~   "
273710|NCT00005677|"~     To evaluate the long-term efficacy of percutaneous transluminal coronary angioplasty (PTCA)~     and alternative angioplasty devices in patients with coronary heart disease. There are four~     registries. The first registry followed 3,079 patients who received PTCA between 1977 and~     1982. The second registry followed 1,500 patients from the first registry for a minimum of~     five years and followed 2,000 newly entered patients who received PTCA in 1985 and 1986 so~     that the second cohort would also be followed for five years. The third registry, the New~     Approaches to Coronary Intervention (NACI), followed approximately 4,424 patients between~     November 1990 and February 1997. The dynamic evaluation study will follow a total of 6,000~     procedures.~   "
273711|NCT00005676|"~     To investigate the relative contributions of high density lipoprotein-C (HDL-C) subspecies to~     risk for coronary heart disease (CHD) in two distinct existing populations (samples from the~     VA-HIT study and the Framingham Offspring Study [FOS]) as well as the response of these~     subfractions to gemfibrozil treatment.~   "
273712|NCT00005565|"~     To determine mechanisms of low levels of apolipoprotein B.~   "
273713|NCT00005564|"~     To assess the separate and interactive effects of asthma severity, subspecialty practice~     variation, asthma-related psychosocial variables, and other factors on asthma outcomes,~     including asthma-specific quality of life and activity limitations, health care utilization~     for asthma, and direct and indirect costs of asthma.~   "
273714|NCT00005563|"~     To study the epidemiology of emergency asthma by focusing on three Multicenter Asthma~     Research Collaboration (MARC) databases collected over a two-year period in adult and~     pediatric emergency departments.~   "
273715|NCT00005562|"~     To investigate coronary artery calcium (CAC), detected by electron beam computed tomography~     (EBCT), as a predictor of coronary heart disease (CHD) mortality and morbidity, stroke, and~     all-cause mortality in a historical cohort epidemiological study.~   "
273716|NCT00005560|"~     To determine if there are anatomic and physical characteristics that distinguish~     pre-adolescent children with sleep disordered breathing and if the sleep disordered breathing~     is associated with adverse effects on school and neurocognitive performance.~   "
273717|NCT00005559|"~     To determine optimal values for transferrin saturation for use in population screening for~     hereditary hemochromatosis.~   "
273718|NCT00005557|"~     To characterize the natural history and biologic spectrum of sleep disordered breathing (SDB)~     and other sleep problems and disorders, and test hypotheses regarding the causes and~     consequences of SDB and other sleep problems and disorders.~   "
273719|NCT00005556|"~     To identify factors that affected the National Marrow Donor Program's (NMDP) success in~     retention of bone marrow volunteers.~   "
273720|NCT00005555|"~     To determine the minimal dose of physical activity necessary to improve cardiovascular (CV)~     health by evaluating and aerobically training 500 healthy men and women, 30-65 years of age.~   "
273721|NCT00005554|"~     To examine some of the psychosocial predictors of poor outcome among revascularized coronary~     artery disease patients.~   "
273722|NCT00005553|"~     To evaluate children undergoing catheter ablation at pediatric centers in North America in~     order to provide information on the incidence rate of serious cardiac damage as a result of~     ablation, the incidence rate and time course of recurrence after initially successful~     ablation, and the incidence rate of proarrhythmia following ablation.~   "
273723|NCT00005552|"~     To characterize the skin route of exposure to the allergen hexamethylene diisocyanate (HDI)~     in the auto body industry.~   "
273724|NCT00005551|"~     To investigate the causes, consequences and quantitation of sleep disordered breathing (SDB).~   "
273727|NCT00005548|"~     To examine the prospective association of green tea consumption to the incidence and~     mortality of coronary heart disease (CHD) using multivariate analysis while controlling for~     the potential confounding effects of cholesterol, triglycerides, glucose and dietary~     nutrients.~   "
273728|NCT00005547|"~     To investigate the role of chronic infection as a risk factor for vascular disease in a study~     of Native Americans. The primary focus is on the two most common agents Chlamydia pneumoniae~     and cytomegalovirus with a secondary emphasis on Helicobacter pylori.~   "
273729|NCT00005546|"~     To identify genes involved in the pathogenesis of three types of congenital heart disease,~     atrial septal defects, paramembranous ventricular septal defects, and atrioventricular canal~     defects.~   "
273730|NCT00005545|"~     To determine if risk factors measured in childhood can predict the development of~     atherosclerotic coronary and carotid artery disease in adulthood.~   "
273731|NCT00005544|"~     To identify the role of irritant exposure in adult-onset asthma by simultaneously using both~     clinical and case control methods in a community-based perspective study of asthma incidence.~   "
273732|NCT00005543|"~     To determine the genetic epidemiology, including genetic and environmental interactions of~     the multifactorial disease, venous thromboembolism (VTE).~   "
273733|NCT00005542|"~     To identify sarcoidosis susceptibility genes and to determine how these genes and~     environmental risk factors interact to cause sarcoidosis.~   "
273734|NCT00005541|"~     To determine the prevalence, genetic and environmental determinants, and potential clinical,~     personal, and societal impact of iron overload and hereditary hemochromatosis, in a~     multi-center, multiethnic, primary care-based sample of 100,000 adults. The study is~     conducted by the Division of Epidemiology and Clinical Applications of the NHLBI, the~     Division of Blood Diseases and Resources of the NHLBI, and the Ethical, Legal, and Social~     Implications (ELSI) Research Program of the NHGRI.~   "
273735|NCT00005540|"~     To study prospectively the interrelationships among physical fitness, activity, other~     measured risk factors, coronary heart disease (CHD) and all-cause mortality in a cohort of~     3,403 firefighters.~   "
273736|NCT00005539|"~     To investigate the prevalence and incidence rates of cardiovascular disease morbidity and~     mortality in people with Type 1 diabetes of long duration.~   "
273737|NCT00005538|"~     To determine the effects of behavioral stress and reproductive hormones on coronary heart~     disease (CHD) risk.~   "
273738|NCT00005537|"~     To perform a genome-wide search for genes affecting two phenotypes related to asthma and~     chronic obstructive pulmonary disease (COPD) in a Chinese population.~   "
273739|NCT00005536|"~     To identify genes causing hypertensive end-stage renal disease (H-ESRD) in high risk~     African-American populations~   "
273740|NCT00005535|"~     To conduct gene mapping studies for quantitative traits.~   "
273741|NCT00005534|"~     To conduct a population-based study of the prevalence of asymptomatic ventricular~     dysfunction.~   "
273742|NCT00005533|"~     To examine the separate and interactive effects of hostility, depressive symptomatology and~     socioeconomic status (SES) in predicting coronary heart disease risk.~   "
273743|NCT00005532|"~     To assess the extent to which consumption of different sources of hydrogenated fat relative~     to unhydrogenated oil or butter alters plasma lipoprotein concentrations and measures of~     lipid metabolism.~   "
273744|NCT00005531|"~     To determine if hereditary susceptibility predisposes African Americans to sarcoidosis and to~     identify sarcoidosis susceptibility genes in African Americans.~   "
273745|NCT00005530|"~     To elucidate dietary factors that elevate risk for cardiovascular disease (CVD) in~     conjunction with insulin resistance.~   "
273746|NCT00005529|"~     To develop and test a self-scored cardiovascular disease health risk appraisal.~   "
273747|NCT00005528|"~     To evaluate the role of known genes involved in lipid metabolism on serum lipid and~     apolipoprotein levels in Samoans residing in American and Western Samoa, who were exposed to~     the biobehavioral changes of modernization.~   "
273748|NCT00005526|"~     To identify the genetic (major genes) and environmental factors responsible for the~     significant aggregation of abdominal aortic aneurysm (AAA) among relatives of affected~     individuals.~   "
273749|NCT00005525|"~     To conduct a genetic analysis of anatomic risk factors for sleep apnea in a~     well-characterized United States population-based registry of elderly male twins who have~     been successfully followed for the past 30 years.~   "
273750|NCT00005524|"~     To examine the vagal, vascular sympathetic, and mechno-structural components of baroreflex~     regulation in coronary artery disease (CAD) patients and healthy age-matched controls during~     rest and acute laboratory stress.~   "
273751|NCT00005523|"~     To conduct a randomized trial in asthmatic children to compare the effectiveness of a~     home-based allergen control program with a customary educational program delivered in offices~   "
273752|NCT00005522|"~     To examine biopsychosocial processes that might contribute to the associations among social~     dominance, gender, and cardiovascular reactivity,.~   "
273753|NCT00005521|"~     To use the meta-analytic approach to examine the effects of aerobic exercise on resting~     systolic and diastolic blood pressure in children.~   "
273754|NCT00005520|"~     To determine whether measured variation in genes coding for components of vasoconstriction~     and volume regulating systems predict interindividual differences in blood pressure response~     to therapy with a thiazide diuretic, hydrochlorothiazide, or an angiotensin II receptor~     blocker, candesartan, in hypertensive African-Americans (N=300 treated with each drug) and in~     hypertensive European Americans (N=300 treated with each drug).~   "
273755|NCT00005519|"~     To examine associations between various dietary elements and the risk of coronary heart~     disease and stroke.~   "
273756|NCT00005518|"~     To determine the risk factors associated with inhibitor formation in hemophilia A and to~     study the mechanism of tolerance in the murine hemophilia A model.~   "
273757|NCT00005517|"~     To conduct a surveillance study of congestive heart failure (CHF).~   "
273758|NCT00005516|"~     To collect fundamental data regarding the distribution of measures of sleep disordered~     breathing (SDB) in a pediatric population, prevalence of clinically significant SDB in~     children, risk factors, and associated co-morbidity.~   "
273759|NCT00005515|"~     To assess the interaction between hormone replacement therapy and the prothrombotic~     mutations, Factor V Leiden and the recently described prothrombin mutation (20210A) on the~     incidence of venous thromboembolism (VTE) in a population-based case-control study conducted~     at Group Health Cooperative of Puget Sound (GHC).~   "
273760|NCT00005514|"~     To study, prospectively, the association between dietary patterns and risk of coronary heart~     disease (CHD), ischemic stroke, and hemorrhagic stroke in cohort studies of 121,700 women age~     30 to 55 years at baseline in 1976 (the Nurses; Health Study; NHS) and 51,529 men aged 40-75~     years at baseline in 1986 (the Health Professionals Follow-up Study; HPFS).~   "
273761|NCT00005513|"~     To examine hypotheses concerning the relationships between nutrient intake (in particular,~     specific fatty acids, antioxidant nutrients, and B vitamins), dietary patterns, plasma~     lipoproteins, and heart disease endpoints in the population-based Framingham Offspring~     Studies.~   "
273762|NCT00005512|"~     To determine how genetic and environmental factors influence the co-occurrence of obesity and~     hypertension during development and to identify cardiovascular risk factors in adolescence~     that will predict cardiovascular disease in adults.~   "
273763|NCT00005511|"~     To determine intermediate traits for sleep apnea in a case-control study.~   "
273764|NCT00005510|"~     To examine the relationship of obesity and body fat distribution to lipoprotein~     concentrations in members of the Strong Heart Study.~   "
273765|NCT00005509|"~     To conduct a cross-sectional study of cardiovascular risk factors in a cohort of Latina~     women.~   "
273766|NCT00005508|"~     To define factors contributing to coronary heart disease (CHD) in high risk families.~   "
273767|NCT00005507|"~     To study the causes of persistent differences in Black-white access to tertiary care~     cardiovascular surgical services (TCCS).~   "
273768|NCT00005506|"~     To investigate the relationship of non-invasively measured flow-mediated brachial artery~     dilation with coronary artery disease (CAD).~   "
273769|NCT00005505|"~     To investigate the contributions of neighborhood environments to the distribution of~     cardiovascular disease (CVD) risk across different age ranges and racial/ethnic groups, using~     data from three ongoing cohort studies of cardiovascular disease: the Coronary Artery Disease~     Risk Development in Young Adults (CARDIA) Study, the Atherosclerosis Risk in Communities~     (ARIC) Study, and the Cardiovascular Health Study (CHS).~   "
273770|NCT00005504|"~     To investigate venous thromboembolism in two carefully conducted prospective epidemiologic~     studies of African American and white adults -- the Atherosclerosis Risk in Communities~     (ARIC) Study and the Cardiovascular Health Study (CHS).~   "
273771|NCT00005503|"~     To document normal developmental changes in cardiac structure and function during late~     childhood and adolescence.~   "
273772|NCT00005502|"~     To study the entire population of Olmsted County, Minnesota, including all age categories, to~     examine the secular trends in coronary heart disease (CHD) mortality, myocardial infarction~     (MI) incidence, and natural history, including MI severity, case fatality and post-MI~     morbidity. Also, to examine the time trends in the prevalence of CHD at post-mortem because~     of the uniquely high autopsy rate in Olmsted County.~   "
273773|NCT00005501|"~     To determine the impact of the treatment of hypertension on the epidemiological analyses of~     blood pressure from observational studies.~   "
273774|NCT00005500|"~     To conduct molecular genetic studies in human pedigrees in order to identify the major genes~     responsible for asthma.~   "
273775|NCT00005499|"~     To investigate trends in the incidence and survival rates of congestive heart failure (CHF)~     in two successive cohorts of elderly people (1970-74, 1990-94) in a health maintenance~     organization (HMO).~   "
273776|NCT00005498|"~     To test the hypothesis that high levels of hostility, depressive symptoms, and stressful life~     events would be associated with all cause and cardiovascular disease (CVD) mortality after 16~     years of follow-up in the Multiple Risk Factor Intervention Trial (MRFIT).~   "
273777|NCT00005497|"~     To conduct a multicenter case-control study of persistent pulmonary hypertension of the~     newborn (PPHN) in relation to maternal exposure to smoking and non-steroidal~     anti-inflammatory drugs (NSAIDs). Also, to assess other potential antenatal risk factors and~     collect and store buccal cell specimens for future analyses.~   "
273778|NCT00005496|"~     To examine markers of underlying chronic inflammation and infection as potential risk factors~     for future myocardial infarction (MI), stroke (CVA), and venous thromboembolism (VTE) in~     plasma samples collected at baseline from healthy participants in the Physicians' Health~     Study (PHS).~   "
273779|NCT00005495|"~     To evaluate the effectiveness of primary prevention of coronary heart disease risk factors by~     examining data from the National Health Examination Survey (NHES) and the National Health and~     Nutrition Examination Surveys (NHANES) to determine whether more recent birth cohorts were~     attaining lower blood pressure and cholesterol levels than earlier birth cohorts.~   "
273780|NCT00005494|"~     To compare rates of coronary heart disease (CHD), cancer, total mortality and exercise~     injuries in 68,000 runners and 68,000 walkers during four years of surveillance~   "
273781|NCT00005493|"~     To analyze existing data from the Physicians Health Study (PHS), a randomized primary~     prevention trial of low-dose aspirin and beta carotene conducted among 22,071 U.S. male~     physicians, to address questions concerning aspirin and cardiovascular (CV) disease that~     could not adequately be addressed during the randomized aspirin period.~   "
273782|NCT00005492|"~     To conduct a pooled analysis of NHANES I/II data on race, gender, and coronary heart disease.~   "
273783|NCT00005490|"~     To identify and measure DNA sequence variation in 13 genes that play a central role in key~     physiological functions involved in the development of cardiovascular disease, that is, genes~     involved in lipid metabolism, carbohydrate metabolism, and blood pressure regulation.~   "
273784|NCT00005489|"~     To identify the role of salt-sensitivity of blood pressure in the pathogenesis of~     hypertension.~   "
273785|NCT00005488|"~     To examine the impact of an interaction between common genetic susceptibility markers and~     environmental exposures on risk for early onset myocardial infarction in cases with~     myocardial infarction and matching controls.~   "
274090|NCT00005181|"~     To correlate dietary factors and changes in pressor substances, including aldosterone and~     norepinephrine, with blood pressure during growth and sexual development from childhood~     through adolescence.~   "
273786|NCT00005487|"~     To conduct a prospective observational study of the characteristics of subclinical~     cardiovascular disease (disease detected non-invasively before it has produced signs and~     symptoms) that predict progression to clinically overt cardiovascular disease in a diverse~     and representative population-based sample of men and women aged 35-84. Specifically the~     study shall: determine characteristics related to progression of subclinical to clinical~     cardiovascular disease; identify factors related to newer measures of subclinical disease and~     examine relationship of new to established measures; and develop population-based methods,~     suitable for application in future screening and intervention studies, for identifying~     asymptomatic persons at highest risk of clinical events.~   "
273787|NCT00005486|"~     To establish a registry of individuals with LAM by forming a consortium of six clinical~     centers and referring physicians who treat LAM patients.~   "
273788|NCT00005485|"~     This is a prospective study of the environmental and genetic factors that influence the~     development of cardiovascular disease (CVD) in African American men and women. The cohort is~     an expansion of the Jackson, Mississippi site of the Atherosclerosis Risk in Communities~     (ARIC) study and is a partnership among two minority institutions (Jackson State University~     and Tougaloo College), one majority institution in Jackson, Mississippi (the University of~     Mississippi Medical Center), the National Institutes of Health (NIH) National Center on~     Minority Health and Health Disparities (NCMHD), and the National Heart, Lung, and Blood~     Institute (NHLBI).~   "
273789|NCT00005484|"~     To identify clinical predictors of episodes of hospital-based care in people with asthma.~   "
273790|NCT00005483|"~     To describe the distribution of homocysteine and prevalence of hyperhomocysteinemia with~     emphasis on race, sex and age. To determine the extent to which hyperhomocysteinemia is~     associated with status of folate and vitamin B12. Finally, to describe the relationships~     between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and~     assess the importance of this risk factor as a cause of vascular disease among US adults. The~     study was renewed for one year to investigate normal homocysteine concentrations among~     children and to identify nutritional and non-nutritional determinants of total homocysteine~     concentrations in children.~   "
273791|NCT00005482|"~     To test the hypotheses that the risk of myocardial infarction and/or stroke is associated~     with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12~     and B6.~   "
273792|NCT00005481|"~     To determine the nature, extent and molecular mechanisms responsible for impaired~     fibrinolysis in White, Black, Hispanic and American Indian populations with respect to the~     presence or absence of diabetes. The overall objective is to determine whether impairments of~     fibrinolysis underlie subclinical and clinical vascular disease in diabetes in specific~     populations with and without accelerated microvascular disease.~   "
273793|NCT00005480|"~     To elucidate the interrelationship of level of cardiovascular disease knowledge and~     subsequent clinical health status by merging population-based cardiovascular disease risk~     factor survey data with patient-level hospital data. The overall goal was to assess outcomes~     in the positive/negative association between level of cardiovascular disease knowledge and~     incidence and relative degree of morbidity among a cohort with and without major~     cardiovascular disease risk factors.~   "
273794|NCT00005479|"~     To better understand the excess cardiovascular disease associated with diabetes mellitus.~   "
273795|NCT00005478|"~     To elucidate the changes in body size, composition, and configuration occurring in~     adolescence, because these are important precursors of change in blood pressure and blood~     lipids.~   "
273796|NCT00005477|"~     To elucidate the influence of ethnicity and socioeconomic status (SES) on women's~     cardiovascular health, using recently completed risk factor and mortality data from the~     Stanford Five-City Project.~   "
273797|NCT00005476|"~     To establish the aspects of ethnicity that are associated with the differential expression of~     cardiovascular disease processes in African Americans and Caucasian Americans twin children.~   "
273798|NCT00005475|"~     To extend follow-up of a birth cohort of asthmatic children through adolescence and on to~     adulthood. .~   "
273799|NCT00005474|"~     To elucidate the biochemical, metabolic, and genetic markers and mechanisms of macrovascular~     disease in insulin dependent diabetes mellitus (IDDM).~   "
273800|NCT00005473|"~     To test hypotheses related to gender differences in cardiovascular mortality trends between~     1980 and 1991 in two southeastern New England communities which were part of the Pawtucket~     Heart Health Program.~   "
273801|NCT00005472|"~     To analyze the association between an objective measure of job strain and risk of stroke,~     and change in ambulatory blood pressure.~   "
273802|NCT00005471|"~     To evaluate the hypothesis that chronic anxiety and/or anxiety disorders resulted in~     hyperkinetic cardiovascular autonomic regulation, often associated with increased coronary~     risk.~   "
273803|NCT00005470|"~     To continue examinations of 670 girls enrolled in the National Growth and Health Study (NGHS)~     for four more years, adding measurements of total peripheral resistance, cardiac output, DEXA~     scans for fat-free mass and fat mass, left ventricular mass and geometry, circulating blood~     volume, whole blood viscosity, and left ventricular contractility.~   "
273804|NCT00005469|"~     To examine a school-based population of children for maturational changes in blood pressure~     and cardiac structures.~   "
273805|NCT00005468|"~     To investigate the variability of lipids and specifically the effects of stress on serum~     triglyceride levels, total cholesterol, HDL, and LDL in a 2.5 year epidemiological study.~   "
273806|NCT00005467|"~     To develop a clinical severity index that could prospectively identify sickle cell disease~     patients who were at high risk for a turbulent clinical course and a poor prognosis.~   "
273807|NCT00005466|"~     To estimate the relative risks of acute myocardial infarction (MI) and of stroke in~     postmenopausal users of estrogen/progestogen (E/P) combinations and to estimate the relative~     risks of MI and of stroke in users of estrogen alone.~   "
273808|NCT00005465|"~     To map the major gene influencing low-density lipoprotein subclass phenotypes, denoted~     atherogenic lipoprotein (ALP) phenotypes, with a long term goal of cloning the ALP gene and~     understanding its role in genetic susceptibility to atherosclerosis.~   "
273809|NCT00005464|"~     To perform extensive analyses of data from the Dietary Intervention Study of Hypertension~     (DISH)..~   "
273810|NCT00005463|"~     To evaluate the cost-effectiveness of cholesterol-lowering strategies in the United States~     population. The study used the Coronary Heart Disease (CHD) Policy Model, a state-transition~     computer simulation model used to obtain forecasts of the public health impact and economic~     cost of CHD in the United States population.~   "
273811|NCT00005462|"~     To identify individual genes that contribute to variation in susceptibility to coronary heart~     disease (CHD) in Mexican Americans. The program project grant supports the San Antonio Family~     Heart Study, the first comprehensive genetic epidemiological study of atherosclerosis and its~     correlates in Mexican Americans.~   "
273812|NCT00005461|"~     To investigate the determinants of valid symptom perception in childhood asthma and the~     relation of symptom perception to asthma morbidity.~   "
273813|NCT00005460|"~     To evaluate factors associated with cardiovascular morbidity and mortality in a cohort of 795~     men and women aged 75 years or older at the time of a comprehensive examination conducted~     between 1984 and 1987.~   "
273814|NCT00005459|"~     To investigate whether women with Polycystic Ovary syndrome (PCOS) have evidence of an~     increased prevalence rate of subclinical atherosclerosis as measured by the presence of~     plaque, increased intima-medial carotid artery wall thickness and lower brachial artery flow~     mediated vasodilation.~   "
273815|NCT00005458|"~     To re-examine the relationship between suppressed anger, elevated blood pressure and~     all-cause as well as coronary heart disease (CHD) mortality using data from the Life Change~     Event Study (LCES) conducted on a representative sample of the Tecumseh Community Health~     Study (TCHS), n=696, men and women, aged 30-69 in 1971-1972.~   "
273816|NCT00005457|"~     To enhance statistical methods for epidemiological studies by extending the Disturbed Highest~     Derivative Polynomial (DHDP) to models for binary-logistic and Poisson data and by including~     random subject effects in the Gaussian model.~   "
273817|NCT00005456|"~     To study calcium metabolism and the renin-angiotensin system in hypertensive and normal~     pregnancy.~   "
273818|NCT00005455|"~     A detailed review was made of data pertinent to the occurrence of chronic Chagas disease in~     the United States.~   "
273819|NCT00005453|"~     To examine the effects of two strategies of inducing enhanced adherence to medication in the~     context of a clinical trial: habit training versus habit training plus problem solving.~   "
273820|NCT00005452|"~     To develop TI (pronounced 'T-sub-I'), a personal computer program to analyze time-varying~     data generated by periodic patient reports, repeatedly-observed disease signs, or serial~     biomarkers to study chronic disease.~   "
273821|NCT00005451|"~     To design Computer Aided Telephone Interviewing (CATI) software tools for survey research.~   "
273822|NCT00005450|"~     To develop an epidemiologic model to estimate the benefits, costs and risks of disease~     prevention in the elderly.~   "
273823|NCT00005449|"~     To examine the role of social support in attenuating ischemic responses to psychological~     stress, both in the laboratory and during daily life.~   "
273824|NCT00005448|"~     To investigate in pregnant women the adverse pulmonary effects of magnesium sulfate (MgSO4),~     a commonly used drug for tocolysis or arrest of labor.~   "
273825|NCT00005447|"~     To provide new scientific information regarding the role of physical activity in primary and~     secondary disease prevention, particularly coronary heart disease (CHD).~   "
273826|NCT00005446|"~     To investigate the relation between endogenous levels of estrogen in postmenopausal women and~     the subsequent development of coronary heart disease.~   "
273827|NCT00005445|"~     To study three possible, but yet unproven, influences on pediatric asthma hospitalization~     rates - diagnostic substitution, different systems of medical care, and asthma medication~     use.~   "
273828|NCT00005444|"~     To investigate familial patterns of hypertension and related cardiovascular (CV) risk factors~     in the United States and Nigeria.~   "
273829|NCT00005443|"~     To improve understanding of three important and intertwined social determinants of health:~     social class, race/ethnicity, and gender.~   "
273830|NCT00005442|"~     To conduct a comprehensive epidemiologic investigation into the relationship between serum~     triglyceride (TG) levels and coronary heart disease (CHD).~   "
273831|NCT00005441|"~     To develop and evaluate a comprehensive lifestyle self-management (CLSM) program (low-fat~     vegetarian diet, smoking cessation and stress management training) for postmenopausal women~     with coronary heart disease and Type II (non-insulin dependent) diabetes.~   "
273832|NCT00005440|"~     To identify risk factors for work disability among adults with asthma treated by pulmonary~     and allergy specialists.~   "
273833|NCT00005439|"~     To help clarify the validity, reliability, and utility of blood pressure (BP) and lipid~     screening in childhood.~   "
273834|NCT00005438|"~     To identify those factors that contributed to cognitive deficiencies in children with sickle~     cell disease (SCD) who had not demonstrated any overt or clinically apparent neurological~     abnormalities.~   "
273835|NCT00005437|"~     To conduct a longitudinal study investigating the physical activity patterns, the~     psychosocial predictors of physical activity, and the effects of physical activity changes on~     blood pressure and body fatness in a cohort of African-American girls, ages 11-17.~   "
273836|NCT00005436|"~     To study longitudinally the incidence, pathogenesis, and risk factors for thrombotic events~     and coronary artery disease in a cohort of patients with systemic lupus erythematosus (SLE).~   "
273837|NCT00005435|"~     To determine the combined effects of hostility, harassment, lipids, and oral contraceptive~     (0C) use on physiological responses in young and middle-aged premenopausal women.~   "
273838|NCT00005434|"~     To confirm the preliminary findings of age, race, and hypertension chronicity effects on~     opioid and cardiovascular responses to stress and to determine the opioid mechanisms~     mediating these effects using an opioid receptor blockade strategy.~   "
273839|NCT00005433|"~     To examine the appropriateness of angiographic and ultrasound endpoints as predictors of~     subsequent clinical coronary events. Follow-up data from the Cholesterol Lowering in~     Atherosclerosis Study (CLAS) were used.~   "
273840|NCT00005432|"~     To identify what happened to specific groups of newborns after surfactant was introduced to~     the market. Were the same benefits with regard to morbidity, mortality, and resource use in~     evidence post treatment investigational new drug (IND)?~   "
273841|NCT00005431|"~     To use data from the Epidemiologic Follow-up Study of the National Health and Nutrition~     Examination Survey (NHANES) to develop models to predict morbidity and mortality as a~     function of risk factors for coronary artery disease. Bivariate dependent survival~     distributions were examined.~   "
273842|NCT00005430|"~     To determine and compare the long term (thirty year) relationship of total cholesterol and~     mortality in Blacks and whites in a predominantly urban Charleston, South Carolina cohort and~     a predominantly rural Evans County, Georgia cohort with special emphasis on the investigation~     of the association of low cholesterol to all cause, cardiovascular disease (CVD), and non-CVD~     mortality.~   "
273843|NCT00005429|"~     To examine clinical cardiovascular outcomes of African Americans.~   "
273844|NCT00005428|"~     To perform data analyses on the familial aggregation of the stress response as it relates to~     hypertension.~   "
273845|NCT00005427|"~     To analyze previously collected data on respiratory illness in early childhood.~   "
273846|NCT00005426|"~     To assess the influence of HDL-subclasses with coronary disease progression, and to identify~     factors influencing HDL subclasses at baseline and over time.~   "
273847|NCT00005425|"~     To determine the effects in early adulthood of asthma, increased bronchial responsiveness,~     markers of allergy and smoking on pulmonary function level and the effects of these same risk~     factors on subsequent decline in pulmonary function, because these early adult factors~     presumably profoundly influence the risk for chronic obstructive pulmonary disease.~   "
273848|NCT00005424|"~     To determine the effect of widowhood on cardiovascular disease.~   "
273849|NCT00005423|"~     To examine dietary quality and subsequent cardiovascular disease (CVD).~   "
273850|NCT00005422|"~     To conduct a longitudinal investigation of early childhood lower respiratory illness (LRI)~     and patterns of lung growth using an existing electronic dataset generated by an 18-year~     study (1972-1990) of a population of 102 Black children followed from birth at the Frank~     Porter Graham Child Development Center.~   "
273851|NCT00005421|"~     To extend analyses of blood pressure (BP) tracking to a period that spanned childhood and~     young adulthood. Data were used from the same cohort of 339 children who had been followed~     for nine to twelve years in a previous study.~   "
273852|NCT00005420|"~     To develop an integrative predictive model of long-term quality of life in cardiovascular~     disease that emphasized adaptive processes and outcomes.~   "
273853|NCT00005419|"~     To study the influences of physical activity on the incidence of hypertension,~     non-insulin-dependent diabetes (NIDDM), and coronary heart disease (CHD), taking into account~     the influences of other life-style elements such as body size, cigarette habit, alcohol~     consumption habits, and parental history of disease on these same chronic diseases.~   "
273854|NCT00005418|"~     To provide a comprehensive analysis of risk factors for the development of clinical~     cardiotoxicities in over 6,000 children with cancer who had been treated on standardized~     protocols involving the use of anthracyclines alone or in combination with other potentially~     cardiotoxic therapies or with no use of anthracycline therapy.~   "
273855|NCT00005417|"~     To seek predictors of mortality, hospitalization, and dialysis using data from a hypertensive~     population which began treatment in 1974.~   "
273856|NCT00005416|"~     To analyze data collected over a four year period on an initial cohort of 3 or 4 year old~     children and their parents in Galveston, Texas, and in Augusta, GA, in regard to~     cardiovascular disease (CVD) physical risk factors and risk related behaviors.~   "
273857|NCT00005415|"~     To determine the magnitude of the relationship between physical activity level and subsequent~     health care utilization over a seven to ten week period in a general population.~   "
273858|NCT00005414|"~     To compare long-term recall of physical activity up to 15 years in the past with physical~     activity reports and physical fitness levels assessed at the baseline examination.~   "
273859|NCT00005413|"~     To investigate stroke risk using the National Academy of Sciences Twin Registry.~   "
273860|NCT00005412|"~     To examine the role of dietary antioxidants in the etiology of atherosclerosis in both sexes~     and in whites and Blacks.~   "
273861|NCT00005411|"~     To continue analysis of data from a longitudinal study of 246 urban Black preschool children~     and their families in order to identify the long-term effects of social and environmental~     influences on nutrition and activity and the consequences of these influences for the~     children's cardiovascular disease (CVD) risk status.~   "
273862|NCT00005410|"~     To conduct an analysis of the epidemiology of coronary heart disease (CHD) in Blacks using~     data collected from the 'Survival and Ventricular Enlargement (SAVE) Following Myocardial~     Infarction' study.~   "
273863|NCT00005409|"~     To study further the association between blood pressure mortality among those who~     participated in both the Hypertension Detection and Follow-up Program (HDFP) screen and the~     East Boston Established Populations for Epidemiologic Studies in the Elderly (EPESE) study.~   "
273864|NCT00005408|"~     To reanalyze data on risk factors for cardiovascular disease (CVD) including total~     cholesterol and high density lipoprotein (HDL) cholesterol for the subjects in the first,~     second, and third exams of the NHLBI Twin Study.~   "
273865|NCT00005407|"~     To define pediatric sex-specific blood pressure percentiles that were a function of both age~     and height. Also, to define the precise age at which blood pressure distributions for~     different racial groups diverged.~   "
273866|NCT00005406|"~     To prospectively examine changes in lipids, lipoproteins, and blood pressure among 295 young~     adults who had been followed for sixteen years in the Beaver County Lipid Study. The Beaver~     County Lipid Study tracked the cholesterol values of 295 children, ages 11 to 14 at baseline.~   "
273867|NCT00005405|"~     To analyze the relationships between parity (childbirth) or gravidity (pregnancy) and~     measures of lipids in groups of women from the Hispanic Health and Nutrition Examination~     Survey (Hispanic HANES) and the Framingham Heart Study.~   "
273868|NCT00005404|"~     To evaluate the relationships of compliance in taking aspirin or aspirin placebo with the~     risk of major cardiovascular endpoints, using data collected in the Physicians' Health Study.~   "
273982|NCT00005289|"~     To investigate risk factors in bronchopulmonary dysplasia (BPD) and to elucidate the~     relationship between BPD, acute lung disease severity, respiration-related variables, water~     balance, nutrition, familial predisposition, and environmental, pregnancy, and delivery~     parameters.~   "
273869|NCT00005403|"~     To utilize national population data sets prepared by the National Center for Health~     Statistics, to (1) examine the current Black disadvantage in cardiovascular (CV) health, (2)~     explore potential clinical and epidemiologic causes, (3) incorporate emerging knowledge of~     new risk factors and (4) compare trends in medical treatment and risk factors for the four~     sex-race groups.~   "
273870|NCT00005402|"~     To identify a large cohort of children transfused in the decade prior to second-generation~     anti-hepatitis C virus (HCV) donor screening (1982-1992). This will not only identify cases~     for the study of persistent infection and chronic hepatitis in children, but will allow for~     the determination of the annualized risk of transfusion-associated hepatitis (TAH) infection~     in children, data that are not currently available.~   "
273871|NCT00005401|"~     To determine whether objectively recorded sleep durations were mortality risk factors,~     whether sleep duration could be distinguished from depression as a risk factor in Women's~     Health Initiative (WHI) data, and whether sleep-associated risks were attributable to~     specific pathophysiologic processes such as sleep apnea, circadian rhythm phase advances, or~     deficiencies of melatonin, or deficiencies of reproductive steroids. The study was ancillary~     to the WHI.~   "
273872|NCT00005400|"~     To examine angiotensinogen genetic variants and adverse pregnancy outcomes.~   "
273873|NCT00005399|"~     To examine factors affecting heart rate variability (HRV) and the role of HRV in heart~     disease. Specifically, to examine the role of HRV: as a predictor of fatal and nonfatal~     ischemic heart disease over a six year follow-up of the Atherosclerosis Risk in Communities~     (ARIC) population based, bi-ethnic cohort; on the six year progression of carotid~     atherosclerosis measured by B-mode ultrasound; and on the incidence of hypertension. Also, to~     study the effect of elevated fasting insulin, glucose, diabetes mellitus, and other metabolic~     abnormalities on changes in HRV over nine years of follow-up.~   "
273874|NCT00005398|"~     To continue surveillance of the participants in the University of North Carolina Alumni Heart~     Study, which tests the hypothesis that hostility and related psychosocial factors are~     involved in the pathogenesis of coronary heart disease.~   "
273875|NCT00005397|"~     To examine the relationship of risk factors measured in childhood to intimal medial thickness~     (IMT) in early adulthood and to examine familial factors which may be related to increased~     IMT, a measure of atherosclerosis.~   "
273876|NCT00005396|"~     To evaluate the efficacy of a motivational intervention designed to reduce children's~     exposure to environmental tobacco smoke in the household and to increase parental motivation~     towards smoking cessation.~   "
273877|NCT00005395|"~     To clarify the relationship of the arterial lesions to aging, define the influence of the~     arterial changes on the development of stroke, brain infarction, and dementia, and provide a~     better understanding of vascular dementia.~   "
273878|NCT00005394|"~     To identify and study a large cohort of glucocorticoid remediable aldosteronism (GRA)~     patients.~   "
273879|NCT00005393|"~     To measure serum concentrations of alpha tocopherol, selenium and all major carotenoids~     (alpha- and beta- carotene, lutein, (beta-cryptoxanthin and lycopene) in Black and white,~     male and female, high and low education individuals aged 18-30 in 1985-86. In subsequent~     renewals additional markers of oxidative stress and endothelial dysfunction have been~     measured in blood collected 7 to 30 years after baseline.~   "
273880|NCT00005392|"~     To conduct several studies on the epidemiology of venous disease.~   "
273881|NCT00005391|"~     To establish and maintain a national registry of children with different forms of~     cardiomyopathy.~   "
273882|NCT00005390|"~     To examine the role of family processes in asthma regulation in three groups of children with~     mild to moderate asthma.~   "
273883|NCT00005389|"~     To evaluate the safety of calcium-channel blockers in the secondary prevention of myocardial~     infarction in women.~   "
273884|NCT00005388|"~     To measure visceral (intraabdominal) fat by computerized tomography (CT) scan and to measure~     resting metabolic rate by indirect calorimetry in 400 CARDIA subjects, ages 28-40 years (100~     of each race/gender group) from the Oakland, California and Birmingham, Alabama centers.~   "
273885|NCT00005387|"~     To investigate the genetic determinants of hypertension in three populations of the African~     diaspora, with a major focus on clarifying the role of genes that code for the~     renin-angiotensin system (RAS).~   "
273886|NCT00005386|"~     To examine the biobehavioral determinants of obesity in Black as compared with white women.~   "
273887|NCT00005385|"~     To describe and delineate in a prospective study the nature and causes of seasonal variation~     of blood lipid levels in the general population.~   "
273888|NCT00005384|"~     To perform a follow-up study of physical activity and dietary behaviors and their~     determinants in 10- to 11-year-old Anglo and Mexican-American children from low- and~     middle-socioeconomic status (SES) families who were studied initially when they were 4 to 7~     years old.~   "
273889|NCT00005383|"~     To examine anger and cardiovascular disease risk in urban youth. The project studied patterns~     of hemodynamic responses to social and nonsocial stressors, ambulatory blood pressure (BP),~     fasting insulin, fasting glucose, lipid profiles, and central obesity in adolescents from a~     wide range of socioeconomic status (SES) backgrounds.~   "
273890|NCT00005382|"~     To provide information necessary for the development of standards for peak expiratory flow~     (PEF) test performance in populations studies.~   "
273891|NCT00005381|"~     To identify the prevalence of sleep apnea (SA) in women and its relationship to age; to~     predict those women at risk for sleep apnea; and to define the natural history of those with~     sleep apnea.~   "
273892|NCT00005380|"~     To distinguish whether the observed gender differences in plasma insulin and insulin~     resistance reflect biologic differences, or whether the gender differences in insulinemia are~     determined by greater adiposity in women. Also, to determine if the hyperinsulinemia per se~     contributes to excess risk for cardiovascular disease in African American women. Finally,~     since higher androgenicity is linked with cardiovascular risk in women, to determine if the~     risk factors associated with hyperinsulinemia are modulated by sex hormones.~   "
273944|NCT00005328|"~     To identify the early emergence and stability of children's hostile behaviors and their~     associated psychophysiological responses to behavioral challenges, which are possible risk~     factors for cardiovascular diseases in adulthood; and to specify their determinants and~     consequences.~   "
273893|NCT00005379|"~     To determine the incidence of tuberculosis in an inner city population, identify risk factors~     for TB, describe the natural history in adults and children, evaluate the effect of~     Mycobacterium tuberculosis (Mtb) co-infection on the progression of human immunodeficiency~     virus disease, and determine factors that contribute to compliance and non-compliance with~     prophylaxis and treatment.~   "
273894|NCT00005378|"~     To test the hypothesis that clinically inapparent sleep-disordered breathing was associated~     with blood pressure elevation, impairment of health-related quality of life, and depression.~   "
273895|NCT00005377|"~     To localize individual genes, called blood pressure quantitative trait genes [BPQTGs], which~     influence blood pressure levels in the population-at- large, and to determine if these genes~     are able to predict the occurrence of essential hypertension or coronary artery disease.~   "
273896|NCT00005376|"~     To establish in children born prematurely a set of links between lung function in late~     infancy and lung function at school age, between lung function at school age and that in~     adolescence, and between lung function in adolescence and that in adulthood in order to~     evaluate pulmonary outcomes of neonatal therapeutic strategies and to relate these strategies~     to lung health in adult life.~   "
273897|NCT00005375|"~     To conduct a prospective study of the determinants of smoking onset in adolescents attending~     Memphis City Schools and to determine the unique predictors of smoking onset in Black versus~     white adolescent females.~   "
273898|NCT00005374|"~     To investigate the genetic influence of candidate gene polymorphisms on risk factors for the~     metabolic insulin resistance syndrome in Japanese American sibships and kindreds. The~     original grant in 1994 had as its objective to understand the genetic epidemiology of~     coronary heart disease (CHD) risk factors in Japanese- American families with probands living~     in Seattle, Washington.~   "
273899|NCT00005373|"~     To study mechanisms of excess coronary ischemia secondary to alterations in autoregulation~     and arteriolar vasoreactivity in Black Americans with hypertension, varying degree of left~     ventricular hypertrophy, and angiographically normal or mildly diseased coronary arteries.~   "
273900|NCT00005372|"~     To investigate the role of serum and dietary antioxidants, serum pro-oxidants, and smoking on~     the progression/regression of carotid intima-media thickness (IMT).~   "
273901|NCT00005371|"~     To use the Multiple Risk Factor Intervention Trial (MRFIT) stored serum bank to do nested~     case-control studies of various serum risk factors in coronary heart disease incidence and~     mortality.~   "
273902|NCT00005370|"~     To conduct a longitudinal study of the relationship between the rate of decline of pulmonary~     function and measurements of cortisol concentration and excretion in a sample of middle-aged~     and older men and their wives. The study tested the hypothesis that persons whose plasma~     cortisol concentrations were relatively low, albeit within the normal range, were predisposed~     to excessively rapid deterioration of pulmonary function during aging.~   "
273903|NCT00005369|"~     To examine whether differences existed between asymptomatic white and African Americans known~     to be at high risk for premature coronary artery disease (CAD) in risk factor distributions,~     prevalence of occult coronary disease, and mechanisms of coronary disease expression.~   "
273904|NCT00005368|"~     To determine prospectively the role of elevated plasma triglyceride (TG) as a risk factor for~     20-year coronary heart disease (CHD) mortality in familial combined hyperlipidemia (FCHL) and~     familial hypertriglyceridemia (FHTG), the familial forms of hypertriglyceridemia. Also, to~     perform genetic epidemiologic studies of recently identified lipoprotein risk factors for~     CHD, including Atherogenic Lipoprotein Phenotypes (ALP) based on subclasses of low-density~     lipoproteins (LDL), Lipoprotein(a) (Lp(a)) and apolipoprotein (apo) B plasma levels, and apo~     E isoforms.~   "
273905|NCT00005367|"~     To conduct a cross-sectional epidemiologic study of the determinants of prolonged heart rate~     corrected QT interval (QTc) among 300 men and 300 woman in the population with the highest~     known risk of SUDS: Southeast Asian refugees in Thailand. .~   "
273906|NCT00005366|"~     To investigate the role of biobehavioral factors in the pathogenesis of concentric left~     ventricular hypertrophy.~   "
273907|NCT00005365|"~     To conduct a longitudinal study of central obesity and related risk factors found to be~     associated with hypertension and atherosclerotic cardiovascular disease (ASCVD) in a~     previously-examined cross-sectional cohort of second-generation Japanese Americans and in a~     newly-recruited cohort of third generation Japanese Americans.~   "
273908|NCT00005364|"~     To determine the genetic epidemiology of coronary heart disease (CHD) risk factors in Blacks.~   "
273909|NCT00005363|"~     To continue a prospective study of the ability of ambulatory blood pressure to predict~     cardiovascular morbidity in patients with mild hypertension.~   "
273910|NCT00005362|"~     To modify and expand an existing pharmacokinetic model for nasal dose as well as to develop a~     new model to estimate tracheobronchial dose of an active agent for each subject in a study of~     acute respiratory health effects.~   "
273911|NCT00005361|"~     To measure lung function and respiratory symptom status in a large cohort of healthy,~     non-smoking 18-22 year old subjects, and relate these measurements to past histories of~     passive smoke and air pollution exposures.~   "
273912|NCT00005360|"~     To assess, in donor-recipient clusters, current models of HIV-1 genetic evolution and~     pathogenesis, based on the sequence diversity displayed by this lentivirus.~   "
273913|NCT00005359|"~     To investigate the genetics of asthma by reexamining a carefully characterized population of~     patients with asthma, and by studying their families.~   "
273914|NCT00005358|"~     To determine if selected circulating blood factors that reflect enhanced thrombogenesis are~     associated with an increased incidence of recurrent coronary events, including cardiac death~     or non-fatal myocardial infarction.~   "
273915|NCT00005357|"~     To establish a registry of primary pulmonary hypertension (PPH), a lethal disease which~     causes progressive obstruction of small pulmonary arteries and to investigate basic~     mechanisms of the disease.~   "
273916|NCT00005356|"~     To investigate hemostatic variables in relation to cardiovascular risk in the Framingham~     Offspring Study cohort.~   "
273917|NCT00005355|"~     To develop, test, and apply comprehensive mathematical models for the interaction of genetic~     and environmental effect on cardiovascular risk with gender differences.~   "
273918|NCT00005354|"~     To investigate the relationship between coronary heart disease risk factors and coronary~     artery calcification in middle age adults from the Muscatine Study. From 1992 through 1995,~     ultrafast computed tomography was used to measure coronary artery calcification. The study~     has been extended through January, 2001 in order to examine the role of electron beam~     computed tomography in detecting the presence and quantity of coronary artery calcification,~     a marker of the atherosclerotic process.~   "
273919|NCT00005353|"~     To establish the incidence, clinical spectrum, and natural history of cardiac dysautonomia as~     defined by heart rate spectral analysis in both HIV infected and noninfected children and to~     evaluate the value of heart rate spectral analysis for predicting dysrhythmias and sudden~     death in infants and children born to HIV infected mothers.~   "
273920|NCT00005352|"~     To conduct a prospective, longitudinal, analysis of the psychophysiological effects of~     chronic exposure to environmental stress. The study took advantage of a unique, naturally~     occurring experiment caused by the relocation of a major international airport.~   "
273921|NCT00005351|"~     To identify the incidence cohort of Olmsted County Minnesota residents with deep venous~     thrombosis (DVT)/pulmonary embolism (PE) from 1966 through 1990. Episodes of DVT or PE~     acquired during hospitalization or in the community were identified for future studies.~   "
273922|NCT00005350|"~     To determine the cost-effectiveness of alternative strategies for cholesterol reduction.~   "
273923|NCT00005349|"~     Using subjects from the Rochester Family Heart Study (RFHS), to characterize predictors of~     coronary artery calcification (CAC), a potent marker of atherosclerosis, among individuals~     from the general population.~   "
273924|NCT00005348|"~     To relate distribution of adipose tissue measured by a then new imaging technique, Magnetic~     Resonance Imaging (MRI) to extracranial carotid atherosclerosis, cardiovascular disease risk~     factors, and to more conventional measures of fat distribution such as body mass index (BMI)~     and waist/hip ratio. The primary hypothesis was that patients with extracranial carotid~     atherosclerosis (cases) had more intra-abdominal fat and a higher ratio of intra-abdominal~     fat to total or subcutaneous fat than age-sex-race matched controls.~   "
273925|NCT00005347|"~     To examine the associations between diet, nutrition and coronary heart disease (CHD)~     incidence over seven years using the Cycle V Framingham Offspring/Spouse examination ; to~     examine the cross-sectional associations between dietary variables and major cardiovascular~     disease risk factors, to examine changes in dietary behaviors and their determinants over~     seven years; and to characterize the influences of dietary behavior changes on risk factor~     status between 1984-88 and 1991-94.~   "
273926|NCT00005346|"~     To understand the mechanism(s) underlying sodium-dependent blood pressure control, and to~     determine the consequences thereof.~   "
273927|NCT00005345|"~     To conduct a genetic epidemiologic study of the coronary heart disease (CHD) risk factors of~     blood lipids and obesity in Black and white girls who participated in the NHLBI-supported~     National Growth and Health Study (NGHS). The study was ancillary to NGHS.~   "
273928|NCT00005344|"~     To determine prospectively the extent to which structural and functional aspects of social~     support influences 'hard' cardiac events such as death and non-fatal myocardial infarction in~     patients with coronary artery disease (CAD) and to identify the behavioral and biological~     mediators of these influences.~   "
273929|NCT00005343|"~     To examine the mechanism through which social support affects morbidity and mortality from~     coronary heart disease.~   "
273930|NCT00005342|"~     To investigate the differences in diet, fat cell morphology and lipoprotein metabolism in~     previously- overweight and naturally lean men and women who ran and who lived sedentary~     lifestyles in order to better understand the relationship between lipoprotein metabolism and~     weight set-point.~   "
273931|NCT00005341|"~     To determine if there were immune sequelae related to the long-term donation of blood or~     blood products.~   "
273932|NCT00005340|"~     To continue an international collaborative study on hypertension in populations of West~     African origin.~   "
273933|NCT00005339|"~     To determine the risk of transfusion-transmitted hepatitis C virus (HCV) in cardiac surgery~     patients before and after donor screening for anti-HCV and surrogate markers of non-A, non-B~     hepatitis (NANBH). Also, to characterize donors who were HCV seronegative and who lacked~     surrogate markers at the time of donation, but whose recipient seroconverted to HCV.~   "
273934|NCT00005338|"~     In the first phase, to establish the relationship of progression of peripheral vascular~     disease (PVD) to plasma homocysteine. In the second phase, to conduct a randomized,~     controlled trial of folic acid treatment of plasma homocysteine in peripheral vascular~     disease.~   "
273935|NCT00005337|"~     To determine whether deficient vagal antagonism of sympathetic nervous system (SNS) actions~     on the heart contributed to increased coronary heart disease risk in hostile persons.~   "
273936|NCT00005336|"~     To conduct a dietary intervention trial to test the lipid lowering response to the National~     Cholesterol Education Program (NCEP) Step Two Diet by free-living hyperlipidemic women and~     men and to compare the response between them.~   "
273937|NCT00005335|"~     To determine the contribution of polymorphic variation in candidate genes involved in lipid~     metabolism in determining quantitative lipoprotein-lipid levels and cardiovascular risk~     factors in Anglo and Hispanic populations of the San Luis Valley in southern Colorado. The~     candidate genes included those for A-IV, B, D, E, H, APO(a), LDL receptor, hepatic lipase,~     lipoprotein lipase, lethicin cholesterol acyletransferase (LCAT), and cholesteryl ester~     transfer protein.~   "
273938|NCT00005334|"~     To study the personality and environmental factors that may determine the short-term and~     long-term sequelae of coronary artery bypass surgery (CABS).~   "
273939|NCT00005333|"~     Originally from 1991 to 1991, to test the hypothesis that differences in hypertension~     prevalence in Nigerian workers were primarily related to differences in socioeconomic status~     (SES). At renewal in 1996, to determine the importance of weight gain and weight-related~     factors in blood pressure.~   "
273940|NCT00005332|"~     To investigate drug-gene interactions on the incidence of non-fatal myocardial infarction and~     stroke for hypertensive patients.~   "
273941|NCT00005331|"~     To conduct a randomized controlled smoking prevention trial to evaluate quality of~     implementation and effectiveness, as a function of provider type (school teacher vs. nurse)~     and training (mediated vs. interactive).~   "
273952|NCT00005320|"~     To determine the degree to which neuro-psychological performance and general health status~     and function may be impaired in subjects with mild and moderate degrees of sleep-related~     respiratory disturbances (SRRD), as compared to subjects with minimal apneic activity. Also,~     to assess the degree to which improvement may occur following specific treatment.~   "
273953|NCT00005319|"~     To develop and apply quantitative methods by which to measure and characterize blood~     transfusion practice in specific diagnoses and procedures; to open scientific communication~     about transfusion practice within and across institutions; and to develop simpler methods for~     estimating annual national blood collections and transfusions.~   "
273954|NCT00005318|"~     To investigate the epidemiology of adult respiratory distress syndrome (ARDS) and the~     evolution of the inflammatory process in patients with acute lung injury.~   "
273955|NCT00005317|"~     To conduct cross-sectional and longitudinal studies of patients with idiopathic pulmonary~     fibrosis (IPF) and patients with progressive systemic sclerosis (PSS), with and without~     associated lung disease.~   "
273956|NCT00005316|"~     To investigate the mechanisms of white coat hypertension and study it further as a risk~     factor for heart damage.~   "
273957|NCT00005315|"~     To evaluate the role of psychosocial factors in the development of hypertension and~     cardiovascular disease.~   "
273958|NCT00005314|"~     To elucidate the role of biobehavioral factors in the etiology, pathogenesis and course of~     coronary heart disease (CHD) and to use this knowledge to devise more effective prevention,~     treatment and rehabilitation approaches.~   "
273959|NCT00005313|"~     To conduct focused studies of lipoprotein physiology and pathophysiology in genetically~     characterized patients with the objectives of understanding disease mechanisms, developing~     better treatments, and identifying and preventing early vascular disease.~   "
273960|NCT00005312|"~     To continue the work of the Collaborative Studies Coordinating Center (CSCC) on international~     studies in cardiopulmonary disease epidemiology. The work was being performed under bilateral~     agreements that the NHLBI had entered into with Russia, The People's Republic of China and~     Pakistan. The contract provided nutritional, epidemiologic and biostatistical services in~     support of these studies.~   "
273961|NCT00005311|"~     To develop a comprehensive database publication (databook) utilizing available published and~     unpublished data on the prevalence of hypertension and its treatment and control in selected~     minority populations in the United States -- Hispanic, Asian and American Indian.~   "
273962|NCT00005309|"~     To examine mechanisms of individual differences in the progression of HIV infection in~     hemophiliacs.~   "
273963|NCT00005308|"~     To estimate the risk of death for patients with different pre- and post-operative hemoglobin~     levels who do not receive blood transfusions and to derive a multivariate model using~     clinical information available pre-operatively that would predict the risk of death~     post-operatively.~   "
273964|NCT00005307|"~     To quantify the role of drugs and other factors in the etiology of agranulocytosis and~     aplastic anemia.~   "
273965|NCT00005306|"~     To compare the clinical, biochemical, and histological status of Non-A, Non-B~     post-transfusion hepatitis patients with that of patients who did not develop~     post-transfusion hepatitis.~   "
273966|NCT00005305|"~     To elucidate the role of hepatitis delta virus (HDV) in the development of chronic liver~     disease in patients with hemophilia.~   "
273967|NCT00005304|"~     To determine the prevalence of hepatitis delta virus (HDV) in a large cohort of hemophiliacs~     and to elucidate the role of HDV in the development and progression of liver disease in this~     population.~   "
273968|NCT00005303|"~     To determine the effectiveness of efforts to eliminate the human immunodeficiency virus (HIV)~     from whole blood and blood components in the blood supply.~   "
273969|NCT00005302|"~     To determine the role of drugs in the etiology of aplastic anemia, agranulocytosis, and~     thrombocytopenic purpura. Drugs used in chemotherapy and immunotherapy were excluded.~   "
273970|NCT00005301|"~     To evaluate factors influencing the risk of transfusion-transmitted human immunodeficiency~     virus (HIV) infection and its progression to clinically significant manifestations.~   "
273971|NCT00005300|"~     To continue to follow the newborn cohort and the over-35 years of age cohort from the~     Cooperative Study of Sickle Cell Disease (CSSCD), a study of the natural history of sickle~     cell disease.~   "
273972|NCT00005299|"~     To quantify the influence of genetic and environmental factors on the development of sleep~     apnea.~   "
273973|NCT00005298|"~     To determine whether airway inflammation secondary to inhalation of specific allergens and~     other environmental agents and functional imbalance of the autonomic nervous system played~     important roles in asthma and chronic bronchitis.~   "
273974|NCT00005297|"~     To determine the prevalence and longitudinal course of sleep apnea among men and women and to~     examine the associations of apnea, oxygen desaturation, snoring, high blood pressure, and~     other biomedical correlates.~   "
273975|NCT00005296|"~     To identify the prevalence of sleep apnea in men and its relationship to age, assess the~     natural history of the disorder, and predict those men at risk.~   "
273976|NCT00005295|"~     To determine risk factors for idiopathic pulmonary fibrosis.~   "
273977|NCT00005294|"~     To determine the impact of bronchopulmonary dysplasia (BPD) on childhood development, family~     functioning, and parental stress.~   "
273978|NCT00005293|"~     To identify risk factors for bronchopulmonary dysplasia/chronic pulmonary disease of~     prematurity and to estimate proportions of this group of disorders attributable to antenatal~     risk factors, perinatal events, and neonatal care procedures.~   "
273979|NCT00005292|"~     To collect data from the 37 participating clinical centers on patients with~     alpha1-antitrypsin deficiency, including those who received replacement therapy with an~     intravenous preparation of alpha1-proteinase inhibitor (A1Pi) concentrate.~   "
273980|NCT00005291|"~     To provide information on morbidity and health care utilization for asthma for a large,~     well-defined population over a 20 year period.~   "
273981|NCT00005290|"~     To establish a population-based registry of interstitial lung disease in Bernalillo County,~     New Mexico.~   "
273983|NCT00005288|"~     To characterize the nature of pulmonary responses to organic dust exposures in order to gain~     insight into patterns of respiratory disease in agricultural workers.~   "
273984|NCT00005287|"~     To measure the cardiopulmonary function in individuals who developed bronchopulmonary~     dysplasia (BPD) at Stanford University Medical Center from 1964-1973 and to determine the~     factors associated with the presence of cardiopulmonary function abnormalities in these~     adolescents and young adults.~   "
273985|NCT00005286|"~     To define the prevalence of Sleep Apnea Syndrome (SAS) in a community-based sample of~     Hispanic adults.~   "
273986|NCT00005285|"~     To determine factors, including maternal cigarette smoking and acute respiratory illness,~     influencing infant lung function at birth and up to five years of age.~   "
273987|NCT00005284|"~     To prospectively identify factors that influence the rate of decline in pulmonary function~     and to identify predictors of chronic obstructive lung disease (COLD) and asthma in a~     population sample of older adults.~   "
273988|NCT00005283|"~     To identify risk factors which predispose individuals to develop asthma and other~     manifestations of allergic disease on exposure to laboratory animals in the workplace.~   "
273989|NCT00005282|"~     From 1981 to 1991, to characterize the role of allergy and airways responsiveness in~     modifying growth of lung function in children and young adults in a community-based random~     population, the Childhood Respiratory Study in East Boston. From 1992 to 1997, to examine the~     relationship of respiratory symptoms and illnesses, cigarette smoking, airways~     responsiveness, and markers of inflammation to growth and decline in lung function in two~     well-characterized and investigated community-based populations of children and adults, the~     Childhood Respiratory Study in East Boston and the Normative Aging Study.~   "
273990|NCT00005281|"~     To continue to evaluate risk factors heretofore determined to be important predictors of~     chronic respiratory symptoms, diagnosis of asthma, and alterations in expected levels of lung~     function in children and adolescents in a new population of young adult women.~   "
273991|NCT00005280|"~     The overall objective of the Center was to develop a scientific data base for the control and~     prevention of acute and chronic lung injury caused by the inhalation of a variety of agents~     in the workplace and in the environment. There were two epidemiologic studies.~      Respiratory Effects of Exposures to Irritant Gases: To collect longitudinal lung function and~     symptom data in chemical manufacturing workers who were exposed to chemical irritants such as~     ammonia, chlorine, phosgene, isocyanates, sulphur dioxide, nitrous oxide, formaldehyde,~     organic acids, hydrochloric acid fluorides, other aldehydes, and acid anhydrides.~      Workers in the Cotton Textile Industry: To detect and quantitate the risk for the development~     of chronic obstructive airways disease which occurred in workers exposed to cotton dust in~     textile manufacturing.~   "
273992|NCT00005279|"~     To determine the natural history, etiology, and interrelationships of emphysema, chronic~     bronchitis, asthma, and related airways obstructive diseases. Also, to determine the~     relationship of acute lower respiratory tract illnesses in infants and children to the~     development of subsequent chronic lung disorders.~   "
273993|NCT00005278|"~     To conduct a multicenter epidemiologic study of the human retroviruses HIV-1, HIV-2, HTLV-I,~     and HTLV-II in volunteer blood donors from areas of the United States that were reportedly at~     high and medium or low risk for HIV. Also, to determine the prevalence of retrovirus~     seropositivity in first time blood donors; and the rate of retrovirus seroconversion in~     repeat blood donors as a measure of incidence of infection; to ascertain risk factors for~     antibody-positive donors; to characterize the blood donor population by geographic location,~     age, sex, race/ethnicity, and donation history to permit analysis on prevalence, incidence,~     and risk factors; to identify recipients of retrovirus-positive blood units and conduct~     clinical and laboratory follow-up of these recipients; and to establish a blood specimen~     repository for long-term storage of specimens from study donors and recipients for future~     testing.~   "
273994|NCT00005277|"~     To determine the natural history of sickle cell disease from birth to death in order to~     identify those factors contributing to the morbidity and mortality of the disease.~   "
273995|NCT00005276|"~     To test specific hypotheses concerning environmental, occupational, lifestyle, and other risk~     factors for sarcoidosis. Also, to examine the familial aggregation of sarcoidosis and to test~     genetic hypotheses concerning its etiology. Finally, to describe the natural history of~     sarcoidosis, particularly in African-Americans who appear to be disproportionately affected,~     and to implement a system for storing biological specimens including blood cells, plasma, and~     serum.~   "
273996|NCT00005275|"~     To test whether sleep-disordered breathing is associated with an increased risk of coronary~     heart disease, stroke, all-cause mortality, and hypertension. The multicenter, longitudinal~     study draws on existing, well-characterized, and established epidemiologic cohorts.~   "
273997|NCT00005274|"~     To determine the prevalence and natural history of pulmonary and cardiac complications~     associated with HIV infection in utero, in infancy, and during early childhood.~   "
273998|NCT00005273|"~     To evaluate the types, incidence, course, and outcome of pulmonary disorders in newly~     diagnosed cases of Acquired Immune Deficiency Syndrome (AIDS), newly diagnosed cases of~     AIDS-related complex (ARC) and newly diagnosed asymptomatic human immunodeficiency virus~     (HIV) infection.~   "
273999|NCT00005272|"~     To evaluate the relationships between smoking rate, gender, and body weight in the Hispanic~     Health and Nutrition Examination I Survey (HHANES) I. Also, to evaluate the independent and~     additive contribution of smoking rate and fasting glucose on body weight in HHANES I and~     NHANES II.~   "
274000|NCT00005271|"~     To investigate the relationship between dietary factors, especially macronutrients, and blood~     pressure in an international, multicenter observational study. A particular focus is to help~     elucidate the role of these dietary factors in accounting for the even more adverse blood~     pressure patterns of less educated population strata, especially in the United States, in~     both less educated Blacks and whites.~   "
274001|NCT00005270|"~     To map the major genetic loci underlying hypertension in approximately 1700 sibling pairs of~     Asian-Pacific Chinese and Japanese origin. The study consists of a two grant network, which~     in turn is part of an NHLBI initiative, the Family Blood Pressure Program (FBPP) consisting~     of four networks.~   "
274030|NCT00005241|"~     To assess whether current oral contraceptive (OC) use (within the previous month) increased~     the risk of myocardial infarction. Also, to assess the combined effects of cigarette smoking~     and oral contraceptive use.~   "
274002|NCT00005269|"~     To localize, identify, and evaluate common polymorphic variation in genes involved in~     determining interindividual differences in blood pressure (BP) levels and essential~     hypertension status in three racial groups: African-Americans, Mexican-Americans, and~     Non-Hispanic Whites. The study consists of a six grant network, which in turn is part of an~     NHLBI initiative, the Family Blood Pressure Program (FBPP) consisting of four networks.~   "
274003|NCT00005268|"~     To identify new genetic loci regulating blood pressure in hypertensive rats and in~     case-controls from relevant human populations. The study consists of a four grant network,~     which in turn is part of an NHLBI initiative, the Family Blood Pressure Program (FBPP)~     consisting of four networks.~   "
274004|NCT00005267|"~     To map and identify the major genetic determinants of hypertension and to study possible~     interactions between genetic and non-genetic factors in defined populations. HyperGEN~     initially consisted of a nine grant network, which in turn is part of an NHLBI initiative,~     the Family Blood Pressure Program (FBPP) consisting of four networks.~   "
274005|NCT00005266|"~     To analyze cardiovascular disease mortality and total mortality in the NAS-NRC Twin Registry~     using a new methodology that allowed for censored observations of outcomes, environmental~     covariates, and unmeasured genotype-environment interactions.~   "
274006|NCT00005265|"~     To examine the natural history of mortality due to coronary heart disease in post-myocardial~     infarction patients from the Beta-Blocker Heart Attack Trial (BHAT) and the Aspirin~     Myocardial Infarction Study (AMIS).~   "
274007|NCT00005264|"~     To conduct a longitudinal, natural history study of cardiovascular disease risk factors in~     children. Growth curves were compared for levels of blood pressure, lipids, cardiac~     structures and function, and related to physical growth and maturation, nutrient intake,~     physical activity, body composition, puberty, and smoking.~   "
274008|NCT00005263|"~     To determine whether postprandial lipoproteins were associated with atherosclerosis, and if~     so, whether the association was statistically independent of that between fasting~     lipoproteins and atherosclerosis.~   "
274009|NCT00005262|"~     To identify risk factors for idiopathic dilated cardiomyopathy and to examine prognostic~     factors over a follow-up period of two to three years.~   "
274010|NCT00005261|"~     To determine whether low total urinary kallikrein activity was prospectively associated with~     new hypertension onset or elevated blood pressures.~   "
274011|NCT00005260|"~     To examine the relationships among psychosocial factors and carotid atherosclerosis,~     myocardial ischemia, arrhythmias, and thrombosis.~   "
274012|NCT00005259|"~     To determine whether the dietary intake of trans-fatty acids derived from partially~     hydrogenated unsaturated fatty acids measured through a biomarker are directly associated~     with the risk of primary cardiac arrest.~   "
274013|NCT00005258|"~     To determine genetic mechanisms responsible for congenital cardiovascular malformations.~   "
274014|NCT00005257|"~     To define the role of dietary variables on changes in plasma cholesterol levels over time in~     the Framingham cohort and the Framingham Offspring cohort.~   "
274015|NCT00005256|"~     To test the hypothesis that the incidence of coronary heart disease and cardiovascular~     mortality could be accurately predicted by the presence of coronary calcific deposits~     detected by cardiac fluoroscopy.~   "
274016|NCT00005255|"~     To determine the association between ischemic heart disease incidence and anthropometric~     indices of body-fat distribution.~   "
274017|NCT00005254|"~     The Veterans Administration Patient Study examined the progression of peripheral arterial~     disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community~     Follow-up Study following subjects with and without PAD from a previous cohort to determine~     subsequent coronary heart disease and cardiovascular disease morbidity and mortality.~   "
274018|NCT00005253|"~     To determine whether treatment with antidepressant, anticonvulsant, and antiarrhythmic drug~     therapies having the potential for proarrhythmia increased the risk of primary cardiac~     arrest. The aim of the original grant, starting in 1990 and ending in 1994, was to determine~     whether use of diuretics for hypertension increased the risk of primary cardiac arrest~     compared to the use of other antihypertensive agents.~   "
274019|NCT00005252|"~     To explain the extremely low cardiovascular mortality among Physicians' Health Study (PHS)~     participants by ascertaining all cardiovascular and total deaths among the 90,457 physicians~     who returned enrollment forms but were not randomized into the study. Also, to compare the~     mortality experience of randomized physicians with various subgroups of non-participants.~   "
274020|NCT00005251|"~     To map the genetic defect responsible for familial hypertrophic cardiomyopathy.~   "
274021|NCT00005250|"~     To screen by electrocardiography the entire population of 1,400 individuals in seven Amish~     Mennonite communities in order to perform genetic linkage studies of long QT syndrome (LQTS).~   "
274022|NCT00005249|"~     To determine the roles of insulin, lipids, body weight and ion transport in blood pressure~     regulation.~   "
274023|NCT00005248|"~     To examine the relationships of obesity and fat patterning with morbidity and mortality in~     Black Americans.~   "
274024|NCT00005247|"~     To define the role of nutritional and dietary variables in determining atherogenic traits and~     morbidity and mortality due to coronary heart disease as observed in the Framingham Heart~     Study cohort and the Framingham Offspring Study cohort.~   "
274025|NCT00005246|"~     To determine whether serum insulin is a risk factor for coronary heart disease morbidity and~     mortality and whether dehydroepiandrosterone sulfate (DHEAS) is a risk factor for coronary~     heart disease mortality. Also, to ascertain the determinants of serum insulin levels among~     middle-aged men.~   "
274026|NCT00005245|"~     To assess the relationship of community socioeconomic (SE) structure to cardiovascular~     disease and all-cause mortality trends in the United States.~   "
274027|NCT00005244|"~     To identify behavioral factors underlying the development of cardiovascular risk in young~     adults.~   "
274028|NCT00005243|"~     To investigate factors which trigger the discharge of implantable cardioverter-defibrillators~     (ICDs).~   "
274029|NCT00005242|"~     To determine the effects of long-term exposure to passive smoking on the cardiovascular and~     oxygen transport systems in pre-adolescent twins.~   "
274031|NCT00005240|"~     To test the hypotheses that hypertensive emergency was associated with non-compliance with~     antihypertensive medication, low level of contact with the medical care system, and alcohol~     abuse and cigarette smoking. Also, to describe the clinical characteristics of patients~     hospitalized with hypertensive emergency including morbidity, mortality, and cost, and the~     extent to which hypertensive emergency occured among previously diagnosed and treated~     hypertensives.~   "
274032|NCT00005239|"~     To examine genetic and environmental influences on several recently identified coronary heart~     disease risk factors in identical and fraternal adult women twins. The risk factors included~     low density lipoprotein (LDL) subclass patterns, plasma apolipoprotein levels, body fat~     distribution, and serum insulin levels.~   "
274033|NCT00005238|"~     To determine the role of environmental stressors in the development of hypertension in Black~     and white school-age children from hypertensive families.~   "
274034|NCT00005237|"~     To acquire a better understanding of the spontaneous clinical behavior of paroxysmal~     tachycardia by studying epidemiologic features of symptomatic tachycardia patients.~   "
274035|NCT00005236|"~     To determine whether there were differences in the prevalence and extent of atherosclerotic~     lesions in the coronaries and aortas between Alaskan natives and non-natives, and whether the~     extent of the lesions was related to omega-3 fatty acids in blood and tissues.~   "
274036|NCT00005235|"~     To evaluate the ability of heart rate variability to identify myocardial infarction patients~     at high risk of dying, particularly from sudden cardiac death.~   "
274037|NCT00005234|"~     To examine the natural histories of coronary artery disease and hypertension in cohorts of~     Black and white men of identical education and occupations.~   "
274038|NCT00005233|"~     To study the absolute concentrations and percent of fatty acids in 480 plasma samples from an~     age and sex stratified random sample of subjects in the Framingham Offspring Study in order~     to calculate the distribution of fatty acids in this general population and to determine the~     inter-relationships among levels of fatty acids, in particular w3 and w6 fatty acids, with~     lipoproteins and apolipoproteins.~   "
274039|NCT00005232|"~     To conduct a five-year follow-up of the population of Gubbio, a town in north central Italy,~     in order to determine the relationship of baseline sodium-stimulated lithium countertransport~     to subsequent change in blood pressure and incidence of hypertension.~   "
274040|NCT00005231|"~     To develop a comprehensive protocol for assessing cardiovascular reactivity to stressors, for~     use in epidemiological and clinical investigations of cardiovascular diseases in healthy~     populations.~   "
274041|NCT00005230|"~     To determine whether a population with isolated systolic hypertension (ISH) had a higher~     prevalence of carotid disease than a normotensive population matched for age and sex, and to~     determine specific risk factors for carotid disease.~   "
274042|NCT00005229|"~     To develop natural history data regarding the incidence, clinical course, prognosis, and~     effects of treatment with anti-viral and immunosuppressive agents on HIV-associated heart~     disease. A second part of the study evaluated a number of possible mechanisms underlying the~     development of HIV heart disease.~   "
274043|NCT00005228|"~     To detect by Doppler echocardiography the incidence of cardiac abnormalities in HIV-positive~     patients in a prospective, longitudinal study.~   "
274044|NCT00005227|"~     To define the incidence and prevalence of AIDS-associated cardiomyopathy. Also, to conduct~     immunopathology and serologic studies in endomyocardial biopsies and autopsy tissues.~   "
274045|NCT00005226|"~     To measure by gas-liquid chromatography the relative concentrations of all saturated and~     unsaturated fatty acids found in the cholesterol ester and phospholipid fractions of plasma~     from 4,000 subjects participating in the Atherosclerosis Risk in Communities (ARIC) study.~     The data were used to clarify the role of various fatty acids in atherosclerosis.~   "
274046|NCT00005225|"~     To determine the relative risk in a defined population of angiographically demonstrated~     coronary artery disease due to genetic polymorphisms at the four apolipoprotein genomic~     regions.~   "
274047|NCT00005224|"~     To examine sex differences in behavioral and psychosocial variables such as occupation, Type~     A behavior, and hostility as they related to primary coronary risk factors.~   "
274048|NCT00005223|"~     To examine the complex interactions among the traditional cardiovascular risk factors,~     particularly lipoprotein and apoprotein levels, genetic and other characteristics, and~     lifestyle habits in elderly women.~   "
274049|NCT00005222|"~     To investigate possible mechanisms responsible for the decline in cardiovascular disease~     mortality among the Framingham Heart Study population and to evaluate the health status of~     survivors in terms of subsequent illness and functional limitations.~   "
274050|NCT00005221|"~     To define new national norms for pediatric blood pressure by adjusting the available data set~     of over 60,000 pediatric blood pressure readings for age, height and gender among children of~     normal body weight.~   "
274051|NCT00005220|"~     To evaluate the cardiovascular effects of postmenopausal hormone replacement therapy and the~     suspected beneficial effects on myocardial infarction and stroke.~   "
274052|NCT00005219|"~     To conduct a two-year follow up of participants in a cross-sectional study of physical~     activity determinants. Predictors of change in vigorous exercise habits and recreational~     walking habits were identified as were determinants of change in the proportion of the sample~     who initiated, maintained, or discontinued exercise.~   "
274053|NCT00005218|"~     To develop a prototype questionnaire for the detection of angina pectoris in Blacks.~   "
274054|NCT00005217|"~     To determine if intermittent ST depression (STD) had an independent impact on survival among~     myocardial infarction patients who participated in the Beta-Blocker Heart Attack Trial~     (BHAT).~   "
274055|NCT00005216|"~     To determine if silent myocardial ischemia was associated with an increased risk of cardiac~     mortality and morbidity during a one to three year follow-up in patients with coronary heart~     disease.~   "
274056|NCT00005215|"~     To determine the relationship of fatal and nonfatal coronary heart disease to lipoprotein~     fractions and other risk factors in a prospective epidemiologic study conducted between 1954~     and 1957.~   "
274057|NCT00005214|"~     To investigate the genetics and epidemiology of fasting and postprandial lipid, lipoprotein,~     and apolipoprotein levels.~   "
274061|NCT00005210|"~     To prospectively explore the relationships of endogenous sex steroid hormones and obesity and~     their interactions with lipoprotein cholesterol and apolipoprotein levels in nine and ten~     year old Black and white adolescent girls for five years during puberty.~   "
274062|NCT00005209|"~     To relate observations at the DNA level to the distribution of coronary heart disease in the~     population at large.~   "
274063|NCT00005208|"~     To elucidate the role of an imbalance in vasodilator prostacyclin (PGI2) and vasoconstrictor~     thromboxane (TxA2) in pregnancy-induced hypertension~   "
274064|NCT00005207|"~     To determine the role of the prorenin-renin-angiotensin-aldosterone system (RAAS) in normal~     and hypertensive pregnancy.~   "
274065|NCT00005206|"~     To determine if low dietary calcium intake and disturbances in maternal calcium metabolism~     were associated with increases in blood pressure in late pregnancy.~   "
274066|NCT00005205|"~     To determine the incidence of type II diabetes and cardiovascular disease among~     Mexican-American and non-Hispanic whites in a 15 to 24 year follow-up of the San Antonio~     Heart Study 1 participants. Also, to perform a 15 to 24 year mortality follow-up of the~     cohort and to examine the Hispanic paradox.~   "
274067|NCT00005204|"~     To determine if hypertensives and normotensives of similar ages had, on average, different~     ratios of 24-hour to overnight excretion of sodium, potassium, and water. Also, to determine~     the number of 24-hour collections needed to characterize individuals with respect to the~     ratios of 24-hour to overnight excretion and to determine if the ratios of 24-hour to~     overnight excretion vary by age and other factors related to blood pressure.~   "
274068|NCT00005203|"~     To perform genetic studies of low density lipoprotein (LDL) subclasses in 160 families in~     whom the probands had metabolically defined hypercholesterolemia.~   "
274069|NCT00005202|"~     To validate two models which categorized patients with syncope into high and low risk for~     either sudden death or diagnostic arrhythmias based on data available from the initial~     history, physical examination, and electrocardiogram.~   "
274070|NCT00005201|"~     To determine the familial occurrence and pathogenesis of idiopathic dilated cardiomyopathy.~   "
274071|NCT00005200|"~     To evaluate possible early neurogenic influence in essential hypertension by monitoring heart~     growth in adolescents over a two year interval.~   "
274072|NCT00005199|"~     To establish a registry in order to collect and analyze baseline and outcome data on patients~     with severe valvular stenosis treated with balloon valvuloplasty.~   "
274073|NCT00005198|"~     To determine the natural history of coronary heart disease in the biethnic community of~     Corpus Christi, Texas.~   "
274074|NCT00005197|"~     To determine the predictors of perioperative cardiac morbidity and mortality in patients at~     high risk who underwent major noncardiac surgery with general anesthesia.~   "
274075|NCT00005196|"~     To examine time trends in the incidence rates of acute myocardial infarction and~     out-of-hospital coronary heart disease deaths as well as changes in the in-hospital and~     long-term case-fatality rates of acute myocardial infarction in the Worcester, Massachusetts~     Standard Metropolitan Statistical Area (SMSA).~   "
274076|NCT00005195|"~     To assess factors associated with safety and efficacy of catheter ablation using direct~     current or radiofrequency energy for the management of patients with drug and/or pacemaker~     resistant cardiac arrhythmias.~   "
274077|NCT00005194|"~     To determine the role played by insulin and biogenic amines in obesity-related hypertension~     and cardiovascular disease.~   "
274078|NCT00005193|"~     To study the relationship between diabetes and various macro- and microvascular complications~     in Oklahoma Indians.~   "
274079|NCT00005192|"~     To determine why Black Americans have a higher prevalence of hypertension than whites by~     examining the interactions of psychosocial stressors and suppressed hostility with genetic or~     constitutional factors.~   "
274080|NCT00005191|"~     To determine the clinical course of coronary artery disease among Blacks receiving medical~     care for symptomatic heart diseases.~   "
274081|NCT00005190|"~     To create a registry of all Oregon children undergoing surgical repair of congenital heart~     disease since 1958 in order to determine mortality, morbidity, and disability after surgery~     and to assess the safety of pregnancy in women with corrected congenital heart disease and~     the risk of prematurity and occurrence of congenital heart defects in offspring.~   "
274082|NCT00005189|"~     To determine whether the degree of carotid artery atherosclerosis, as measured by B-mode~     ultrasound, predicts the development of myocardial infarction, stroke, and all-cause~     mortality in patients with angiographically defined coronary status. Also, to quantify the~     rate of progression of carotid artery disease and to evaluate the risk factors associated~     with progression of carotid atherosclerosis.~   "
274083|NCT00005188|"~     To assess the mode of inheritance of familial combined hyperlipidemia and familial primary~     hypoalphalipoproteinemia and to resolve genetic and familial environmental effects on several~     phenotypes of importance to coronary heart disease.~   "
274084|NCT00005187|"~     To characterize the epidemiology and genetics of apolipoproteins A-I, A-II, B, C-II, C-III,~     and E in a population of Mexican-Americans in Starr County, Texas.~   "
274085|NCT00005186|"~     To identify and describe the distribution of risk factors for cardiovascular disease in a~     cohort of free-living elderly persons.~   "
274086|NCT00005185|"~     To evaluate whether the use of noncontraceptive estrogen influenced the incidence of first~     myocardial infarction in women.~   "
274087|NCT00005184|"~     To assess the association of immunogenetic factors with onset of coronary heart disease and~     the interrelationship of these factors with standard coronary heart disease risk factors.~   "
274088|NCT00005183|"~     To further define the linkage of the Apo A-I gene polymorphism to genetic high density~     lipoprotein (HDL) deficiency and premature coronary artery disease. Also, to utilize this~     gene marker to define the prevalence of genetic HDL deficiency in patients with premature~     coronary disease and to determine the relative risk of premature coronary disease associated~     with the Apo A-I gene polymorphism.~   "
274089|NCT00005182|"~     To test the hypothesis that increased risk of coronary heart disease, stroke, peripheral~     vascular disease, and cancer is related to diets high in saturated fat, animal protein, and~     hydrogenated vegetable oil, and low in polyunsaturated fat, fiber, vitamins A, C, and E,~     calcium, selenium, and chromium.~   "
274091|NCT00005180|"~     To determine the distribution of left ventricular hypertrophy and retinal vascular~     abnormalities in children and adolescents with essential hypertension; to evaluate potential~     risk factors and the time sequence for the development of these end-organ complications in~     this population.~   "
274092|NCT00005179|"~     To document the patterns of influence or socialization from parents to children in regard to~     the transmission of cardiovascular disease risk related behaviors such as diet and physical~     activity.~   "
274093|NCT00005178|"~     In the first study, to identify children at high and low risk for cardiovascular disease and~     study their nutritional and physical activity behaviors as they relate to cardiovascular~     disease. In the second study, to make yearly assessments over a four year period of diet and~     physical activity among children and their parents. The initial effort redefined and retested~     methods to collect data on dietary intake and activity levels of young children.~   "
274094|NCT00005177|"~     To study weight maintenance behaviors, weight trends, and behavioral differences between~     healthy, normal weight and mildly obese adults.~   "
274095|NCT00005176|"~     To investigate the clinical, genetic and cardiologic aspects of the Long QT Syndrome, a~     predominantly hereditary disease with episodic malignant arrhythmias and sudden death, and a~     demonstrated gene linkage in a large pedigree.~   "
274096|NCT00005175|"~     To evaluate the relation between blood pressure and socioeconomic status, electrolyte intake,~     obesity and psychosocial factors in Black and white students. Also, to compare blood~     pressure, cardiovascular risk factors, sodium and potassium excretion in United States Blacks~     with West African Blacks.~   "
274097|NCT00005174|"~     To conduct a 25-year follow-up of the surviving participants in the Western Collaborative~     Group Study, the first large prospective study of coronary heart disease risk factors to~     incorporate direct assessment of Type A behavior.~   "
274098|NCT00005173|"~     To evaluate whether the long-term use of oral contraceptives, after discontinuation, was~     associated with an increased incidence of first nonfatal myocardial infarction among women~     above the age of 50.~   "
274099|NCT00005172|"~     To investigate psychosocial and dietary influences on blood pressure in Blacks.~   "
274100|NCT00005171|"~     To describe secular trends in cardiovascular risk factors in the adolescent and adult United~     States population and to identify and quantify the changes in variables related to these risk~     factors. Also, to modify and implement the statistical methodology available for the analysis~     of complex sample survey data in order to model and test these secular trends across separate~     nationally representative databases. The differences in risk factors in these samples were~     contrasted with those from a special population group, Hispanic Americans.~   "
274101|NCT00005170|"~     To determine ways in which behavioral factors influenced the diagnosis and development of~     hypertension in adult working populations.~   "
274102|NCT00005169|"~     To monitor the relationship of lifestyle variables, particularly exercise, to cardiovascular~     mortality, all-cause mortality, projected longevity and aging, and cardiovascular morbidity~     in a large cohort of college graduates. To assess changing patterns of exercise, cigarette~     smoking, body weight, and blood pressure between the 1960s and 1990s for relationship to~     cardiovascular morbidity and mortality.~   "
274103|NCT00005168|"~     To determine the role of apolipoprotein B and apolipoprotein A1 in the etiology of coronary~     artery disease.~   "
274104|NCT00005167|"~     To determine the effects of diet modification on blood pressure, blood cholesterol, and bone~     density in healthy young people.~   "
274105|NCT00005166|"~     Originally, to determine whether genetic alterations in pathways of sodium ion transport in~     the red blood cells of children could predict their risk of developing primary hypertension~     in adulthood. In 1992, the objective was to determine the genetic basis of interindividual~     variation in the risk of essential hypertension in the population at large using the~     Rochester Family Heart Study.~   "
274106|NCT00005165|"~     To examine the role of isolated systolic hypertension and other predictors of all-cause and~     coronary heart disease mortality in elderly Blacks and whites of the Charleston Heart Study~     cohort of 1960 and to compare and pool those findings with the Evans County Heart Study~     findings in order to develop a logistic risk function for Blacks. Also, to identify~     predictors of physical functioning in older Blacks and whites and to prepare rosters of the~     off-spring of the Charleston cohort for future studies of genetic/familial influences on~     cardiovascular disease.~   "
274107|NCT00005164|"~     To determine the role of insulin resistance in peripheral vascular dynamics, sodium~     sensitivity, and blood pressure regulation in a young representative Black population and in~     a group of young Blacks at high risk for hypertension.~   "
274108|NCT00005163|"~     To field test the validity, reliability, cost, and cost-benefit of Health Risk Appraisal~     (HRA) instruments.~   "
274109|NCT00005162|"~     To continue a study of premature coronary heart disease mortality among men and women aged~     35-54 in Allegheny County, Pennsylvania.~   "
274110|NCT00005161|"~     To analyze the genetic and environmental contributions of juvenile hemodynamic determinants~     of blood pressure, including cardiac output and systemic vascular pressure, to adult~     cardiovascular risk.~   "
274111|NCT00005160|"~     To determine cardiovascular risk factors and the change in risk factors during and following~     the menopause.~   "
274112|NCT00005159|"~     To estimate probabilities of death by cause for a representative United States population,~     according to age, sex, race, occupation, industry, income, education, residence, country of~     birth, calendar year, and a number of other demographic and epidemiologic factors. The~     representative population is derived from selected Bureau of the Census files and is matched~     to the National Death Index maintained by the National Center for Health Statistics. The~     Bureau of the Census provides the data processing, coding and management necessary to~     complete this objective.~   "
274113|NCT00005158|"~     To determine the genetic components of hypertension using a series of simulation experiments~     designed to determine the power and validity of the then recently developed methods of~     segregation and linkage analysis.~   "
274217|NCT00004730|"~     The purpose of the study is to determine whether magnesium sulfate, given within 8 hours of a~     moderate or severe traumatic brain injury improves survival, decreases the number of people~     developing seizures, improves the survivors' mental and psychological functioning, including~     the ability to return to daily life, live independently, and return to work or school.~   "
274114|NCT00005157|"~     To improve the predictive validity of Structured Interview assessments of Type A behavior by~     comparing interviewer techniques in the Multiple Risk Factor Intervention Trial (MRFIT) and~     the Western Collaborative Group Study (WCGS). To assess whether there were interviewer~     differences in the predictiveness of Type A behavior and its components for coronary heart~     disease incidence in MRFIT and WCGS and if so, to assess whether the interviewer differences~     in disease predictiveness were related to interviewer stylistics.~   "
274115|NCT00005156|"~     To ascertain the sixteen year mortality status of the 361,662 middle-aged men screened in~     1973-1975 for the Multiple Risk Factor Intervention Trial (MRFIT).~   "
274116|NCT00005155|"~     To test the physiological and psychosocial correlates of Type A behavior.~   "
274117|NCT00005154|"~     To supplement the fourth National Health and Nutrition Examination Survey protocol to include~     data on the common heart, vascular, lung, and blood diseases.~   "
274118|NCT00005153|"~     To identify genetic and environmental risk factors for congenital cardiac disease.~   "
274119|NCT00005152|"~     To determine the relationships of hormonal, reproductive, dietary, and lifestyle factors, as~     well as biochemical and genetic factors, with the subsequent risk of coronary heart disease~     and other cardiovascular events in a cohort of female registered nurses. Recent aims have~     focused on inflammatory biomarkers, adipokines, and metabolomics, including gut microbiota~     metabolites such as trimethylamine N-oxide, choline, and L-carnitine.~   "
274120|NCT00005151|"~     To conduct a community-based research and demonstration project in cardiovascular disease~     prevention in the town of Pawtucket, Rhode Island. Targeted risk factors included high blood~     pressure, elevated blood cholesterol, obesity, cigarette smoking, and sedentary living. To~     evaluate the program, risk factor surveys on a cross-sectional and cohort basis were~     conducted along with mortality and morbidity surveillance both in Pawtucket and in the~     non-intervention comparison town of New Bedford, Massachusetts.~   "
274121|NCT00005150|"~     To conduct a large-scale community-based demonstration and education research project~     designed to evaluate the effectiveness of multiple educational strategies on risk factor~     reduction and the primary prevention of population-wide cardiovascular diseases in three~     intervention communities compared with three control communities. The program was evaluated~     by cross-sectional surveys, a longitudinal survey, and morbidity and mortality surveillance.~   "
274122|NCT00005149|"~     To determine the pathophysiology of different types of essential hypertension by identifying~     the discrete effects of major genes and environmental variables as determinants of the~     subtypes of essential hypertension.~   "
274123|NCT00005148|"~     To determine the incidence, secular trends, and outcomes of coronary heart disease in the~     population of Rochester, Minnesota.~   "
274124|NCT00005147|"~     To determine the role of genetic factors in predicting resistance and susceptibility to~     coronary artery disease.~   "
274125|NCT00005146|"~     To determine factors beyond obesity which contribute to diabetes and cardiovascular risk in~     Mexicans and Mexican Americans. To test the hypothesis that at any given level of adiposity~     Mexican Americans will be more insulin resistant than Anglos and that the insulin resistance~     in Mexican Americans is proportional to the degree of Native American ancestry.~   "
274126|NCT00005145|"~     To continue surveillance of cardiovascular disease risk factors in the seven-county area of~     Minneapolis-St. Paul.~   "
274127|NCT00005144|"~     To further clarify the concept of coronary-prone behavior and to develop methods of assessing~     coronary-prone behavior. Specifically, to revise the component scoring system for Potential~     for Hostility in the Structured Interviews measure of Type A behavior.~   "
274128|NCT00005143|"~     To conduct a large-scale demonstration and education project designed to evaluate the~     feasibility and effectiveness of long-term community health education directed toward~     lowering cardiovascular disease risk, morbidity, and mortality. Targeted risk factors~     included general lifestyle, smoking, blood pressure, nutrition and weight, and exercise. The~     program was evaluated by biennial cross-sectional independent surveys, longitudinal studies,~     and morbidity and mortality surveillance.~   "
274129|NCT00005142|"~     To determine the prevalence of peripheral arterial disease in a defined population by~     non-invasive techniques; to evaluate the association of cardiovascular disease risk factors~     with peripheral vascular disease; to determine whether non-invasive tests of peripheral~     arterial disease can be utilized as markers for coronary heart disease; to determine the~     status of the microvasculature using conjunctival photographs and to compare the results with~     risk factors and the peripheral arterial disease testing results.~   "
274130|NCT00005141|"~     To examine environmental and familial correlates of childhood blood pressure in order to~     predict elevated blood pressure in young adulthood. Also, to investigate the phenomena of~     tracking of blood pressure and obesity from childhood to young adulthood.~   "
274131|NCT00005140|"~     To continue the comprehensive research program on the epidemiology of cardiovascular and~     other major chronic diseases, including cancer and diabetes, in four Chicago population~     cohorts. The four cohorts include the Chicago Heart Association Detection Project in Industry~     cohort, the Peoples Gas Company cohort first examined in 1958-1959, the Peoples Gas Company~     cohort first examined in 1959-1962, and the Western Electric Company cohort.~   "
274132|NCT00005139|"~     To determine the genetics and epidemiology of different types of early familial coronary~     disease. Accurate markers of major gene syndromes for early coronary disease were identified~     using a genetic segregation and linkage study of lipids, lipoproteins, apolipoproteins, and~     DNA probes in 36 large Utah pedigrees.~   "
274133|NCT00005138|"~     To continue a longitudinal study of blood pressure and blood pressure correlates in a~     population of 1,140 young adults, first seen in 1973 as adolescents, aged 14-19 years.~   "
274134|NCT00005137|"~     To document the role of the genotype in the cardiovascular and metabolic responses to aerobic~     exercise-training and the contribution of inherited factors in the changes brought about by~     regular exercise for several cardiovascular disease and diabetes risk factors. A consortium~     of laboratories from five institutions in the United States and Canada are carrying out this~     study.~   "
274317|NCT00004658|"~     OBJECTIVES: I. Evaluate the efficacy of oral ribose in patients with a complex~     5'-nucleotidase syndrome who have not received uridine (UR) and thymidine (TDR).~      II. Evaluate the efficacy of UR/oral ribose and UR/TDR. III. Evaluate the efficacy of oral~     ribose given in combination with UR/TDR.~   "
274135|NCT00005136|"~     To identify and evaluate genetic and non-genetic determinants of coronary heart disease~     (CHD), atherosclerosis, and their risk factors in ongoing population-based epidemiology~     studies. The multicenter study was conducted in three phases which were: Phase I, the family~     history component: Phase II, the clinical examination and follow-up component; and Phase III,~     the molecular genetic and genetic epidemiology studies component.~   "
274136|NCT00005135|"~     To conduct a multicenter study of the relationship between insulin resistance and~     cardiovascular disease (CVD) and its risk factors in a tri-ethnic (African-American,~     Hispanic, and non-Hispanic white) population aged 40 to 69 years at baseline. Also, to~     identify the genetic determinants of insulin resistance and visceral adiposity.~   "
274137|NCT00005134|"~     To determine morbidity and mortality from cardiovascular disease among American Indians and~     to compare cardiovascular disease risk factor levels among Indian groups living in different~     geographic areas.~   "
274138|NCT00005133|"~     To determine the extent to which known risk factors predict coronary heart disease and stroke~     in the elderly, to assess the precipitants of coronary heart disease and stroke in the~     elderly, and to identify the predictors of mortality and functional impairments in clinical~     coronary disease or stroke.~   "
274139|NCT00005132|"~     To determine if the Black-white differences in the development of obesity in pubescent~     females were due to differences in psychosocial, socioeconomic and other environmental~     factors. Also, to determine whether differences in the development of obesity led to~     Black-white differences in other coronary heart disease risk factors, such as blood pressure~     and serum lipids.~   "
274140|NCT00005131|"~     To measure associations of established and suspected coronary heart disease risk factors with~     both atherosclerosis and new coronary heart disease events in representative cohorts from~     four diverse United States communities. To compare the communities with respect to risk~     factors, medical care, atherosclerosis, and coronary heart disease incidence. ARIC has two~     components in each community: study of representative cohorts of adult men and women, and~     community surveillance of morbidity and mortality.~   "
274141|NCT00005130|"~     To measure changes in coronary heart disease risk factors in cohorts of Black and white males~     and females 18 to 30 years of age at baseline. Also, to identify life styles during this age~     span which influence these changes in risk factors.~   "
274142|NCT00005129|"~     To determine the natural history of atherosclerosis, coronary artery disease, and~     hypertension in children and adults from birth through mid-life in a total biracial~     community.~   "
274143|NCT00005128|"~     To conduct epidemiologic surveys of the distribution, causes, and consequences of the~     dyslipoproteinemias. The Population Studies include the Prevalence Study, the Family Study,~     and the Mortality Follow-up Study and shared the same general population base.~   "
274144|NCT00005127|"~     To conduct longitudinal and cross-sectional studies of risk factors for coronary heart~     disease and hypertension in school age children and adults who had been examined in previous~     screens.~   "
274145|NCT00005126|"~     To conduct a baseline survey on cardiovascular, respiratory, and other major systemic disease~     and risk factors in members of the Vietnam Era Twin Registry.~   "
274146|NCT00005125|"~     To continue a registry of World War II veteran twins maintained by the National Academy of~     Sciences-National Research Council (NAS-NRC).~   "
274147|NCT00005124|"~     To assess genetic effects on the variation of cardiovascular and pulmonary risk factors in a~     cohort of 514 pairs of white male veteran twins.~   "
274148|NCT00005123|"~     To investigate coronary heart disease and stroke among American men of Japanese ancestry who~     were living on the island of Oahu in 1965. Morbidity and mortality surveillance of the~     original cohort is continuing.~   "
274149|NCT00005122|"~     To conduct surveillance of cardiovascular morbidity and mortality and its correlation with~     known risk factors in all cohort study groups in Evans County, Georgia.~   "
274150|NCT00005121|"~     The Framingham Heart Study was initiated to study the factors associated with the development~     of cardiovascular disease by employing long-term surveillance of an adult population in~     Framingham, Massachusetts. The Framingham Offspring Study was initiated to assess familial~     and genetic factors as determinants of coronary heart disease.~   "
274151|NCT00005673|"~     This 2-part study will test the safety and anti-HIV activity of capravirine alone, and the~     safety, anti-HIV activity, and drug interactions of capravirine combined with other anti-HIV~     drugs. Capravirine belongs to a class of drugs called non-nucleoside reverse transcriptase~     inhibitors (NNRTIs), which are effective when used together with other drugs, including~     nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitors.~      Normal volunteers 18 years of age and older may enroll in Part 1 of the study. HIV-infected~     patients 18 years of age and older who have not previously been treated with a NNRTI~     (efavirenz, nevirapine, and delavirdine) may participate in Part 2. All prospective study~     participants will be screened for eligibility with a physical examination, blood tests, a~     urine test and an electrocardiogram (ECG).~      Part 1 - Volunteers will be randomly assigned to one of two treatment groups as follows:~      Group 1 will receive capravirine alone for 7 days and capravirine plus efavirenz (another~     NNRTI) for an additional 10 days. On day 1, participants will have a physical examination,~     urine test and laboratory blood tests. Blood samples will be collected just before the first~     dose of capravirine is given and again at 0.5, 1, 2, 4, 6, 8 and 12 hours after the dose. A~     small plastic tube will be placed in a vein to avoid multiple needle sticks. On day 8,~     participants will have another physical examination and laboratory blood tests. Blood samples~     will be drawn again as described above. In the evening of day 8, efavirenz will be added to~     the regimen. On day 18 (the last day of the study), participants will have another physical~     examination and blood tests. Blood will again be collected as described above.~      Group 2 will take capravirine alone for 8) days and capravirine plus ritonavir (a protease~     inhibitor) for an additional 8 days. Physical examinations, urine tests, and blood~     collections will be done as described above on day 1, day 8 and day 16 (the last day) of the~     study.~      Part 2 - Patients will take capravirine alone for 7 days. On day 1, patients will have a~     physical examination, urine test and laboratory blood tests. Blood samples will be collected~     just before the first dose of capravirine is given and again at 0.5, 1, 2, 4, 6, 8 and 12~     hours after the dose. A small plastic tube will be placed in a vein to avoid multiple needle~     sticks. On day 8, patients will have another physical examination and laboratory blood tests.~     Blood samples will be drawn again as described above. Additional drugs will then be added to~     the regimen (in varying doses according to group), as follows:~      Group 1 - efavirenz plus abacavir~      Group 2 - ritonavir plus efavirenz plus abacavir~      Group 3 - ritonavir plus efavirenz plus abacavir~      On day 15, the procedures performed on day 8 will be repeated.~      Patients will have the option of having blood drawn daily on days 2 through 7 to measure~     HIV-1 viral load and of having a lumbar puncture (spinal tap) done between days 2 and 7 to~     measure how well capravirine gets into the central nervous system.~      After day 15, patients in all groups will continue with their drug regimen until week 48 or~     until it is determined that the treatment is not effective for the patient. Physical~     examinations, viral load measurements, white blood cell counts and other blood tests will be~     done periodically throughout the trial. Within 4 weeks after the end of the study, patients~     will be followed with another physical examination, blood and urine tests, and an ECG.~   "
274179|NCT00005103|"~     OBJECTIVES: I. Determine the effect of standard treatments on various predisposing factors in~     patients with porphyria cutanea tarda (PCT).~      II. Investigate alcohol history, smoking, liver dysfunction and its etiology, estrogen use,~     and family history of PCT in these patients.~      III. Study the relationships of excess iron and the hemochromatosis gene to PCT, including~     clinical features and risk of recurrence in these patients.~      IV. Assess hepatitis C virus infections in these patients. V. Assess vitamin C levels in~     these patients before and after treatment. VI. Assess dietary habits in these patients. VII.~     Assess activity of cytochrome P450 enzymes (CYP) in vivo in these patients.~      VIII. Study polymorphic genes for enzymes that metabolize foreign chemicals, including CYP~     enzymes and glutathione transferases in these patients.~   "
274152|NCT00005671|"~     This study will examine the health-related quality of life in patients being treated for~     chronic heart disease.~      Patients 18 years or older with chronic ischemic heart disease and left ventricular~     dysfunction enrolled in protocols in the National Heart Lung and Blood Institute's Cardiology~     Branch may participate in this study.~      Participants will complete five questionnaires at 3 separate times during the study-once~     during hospitalization at the NIH Clinical Center and again at home 6 months and 1 year~     later. The questionnaires, described below, require a total of about 30 minutes to complete.~        1. Demographic Information Sheet -General information such as age, marital status,~          employment, education, and history of cardiac medical procedures.~        2. General Health Survey -Patient's self-assessment, on a rating scale, of physical and~          emotional well being. Questions are related to the ability to perform work and daily~          living activities, mood and state of mind, limitations on social activities, energy~          level, pain level, general quality of life, etc.~        3. Heart Disease Survey - Patient's self-assessment, on a rating scale, of the level of~          physical, social, emotional and functional well being related to his or her heart~          condition. Questions concern fatigue level, emotional outlook, social well being, etc.~        4. Angina Survey - Information on the frequency of chest pain, chest tightness, or angina.~        5. Symptom Distress Survey - Patient's ranking of the degree of symptom distress from chest~          discomfort, difficulty breathing, heart rate irregularities, wheezing and coughing.~      All information provided in the questionnaires will be kept confidential. Upon request,~     patients will be sent a summary of the study results when the study is completed.~   "
274153|NCT00005669|"~     This study will examine the safety and effectiveness of the medicine metformin to help~     overweight children control their food intake, weight, insulin, cholesterol, and triglyceride~     (blood fat) levels. Obesity and high insulin levels can lead to high blood pressure,~     diabetes, high cholesterol and triglyceride levels and heart disease. Metformin-approved by~     the Food and Drug Administration to treat adults with type 2 diabetes mellitus-helps lower~     insulin levels and may control weight gain in adults.~      Overweight children 6 to 11 years old who are in general good health may be eligible for this~     study. Children will be studied at the National Institutes of Health in Bethesda, Maryland.~     Candidates will have a medical history and physical examination and fasting blood test, and~     will provide a 7-day record of their food intake as part of the screening process. Those~     enrolled will be randomly assigned to receive either metformin or placebo (a look-alike~     tablet with no active medicine) twice a day for a six month period. After the 6 month study~     period, all children will be offered the opportunity to take metformin for another 6 months.~      Participants will be hospitalized for 2-3 days for the following procedures: history and~     physical examination; fasting blood test; several urine collections; X-ray studies to~     determine bone age and amount of body fat and muscle; magnetic resonance imaging (MRI) scan~     to measure body fat; hyperglycemic clamp study to evaluate insulin resistance; food intake~     testing; nutrition consultation; resting metabolic rate; and a doubly labeled water test.~      For the hyperglycemic clamp study, a catheter (thin flexible tube) is inserted into a vein in~     each arm. A sugar solution is given through one tube and blood samples are drawn every 5~     minutes through the other to measure insulin. For the food intake testing, the child is asked~     about his or her hunger level, then given various foods he or she may choose to eat, then~     questioned again at various intervals both during and after finishing eating about his or her~     hunger level. The doubly labeled water study involves drinking heavy water (water which is~     enriched to have special kinds of hydrogen and oxygen). Urine specimens are collected 2, 3~     and 4 hours after drinking the water. The child also drinks a special milk shake called a~     Scandishake and repeats the calorie intake and hunger study. (Two food intake studies are~     done on separate days.) One week after the heavy water test, additional urine samples are~     collected one week later.~      After completing the tests, the child will begin treatment with metformin or placebo, plus a~     daily vitamin tablet. Participants will be followed once a month with a brief history and~     physical examination, including a blood test. After 6 months, all of the tests described~     above will be repeated. All children who complete the second round of tests-both those who~     took metformin and those who took placebo-will be offered metformin for an additional 6~     months and will be seen once a month for follow-up evaluations. Parents will not be told~     which children received metformin and which received placebo until all children in the study~     complete the first 6 months of the trial.~   "
274154|NCT00005667|"~     Enterococci, especially vancomycin resistant enterococci (VRE), are increasing in prevalence~     in many hospitals in the United States. Patients undergoing liver transplantation are at~     particular risk for developing infection due to VRE. The effect of prior colonization with~     VRE on the outcome of liver transplantation is unknown. This prospective study will ascertain~     the prevalence of gastrointestinal colonization with vancomycin resistant enterococci among~     patients awaiting liver transplantation at the University of Michigan Health System. Risk~     factors for acquisition of the organism, natural history of colonization and outcome in~     colonized patients will also be determined. All patients currently listed on a priority~     waiting list for liver transplantation at UMHS will be invited to participate. Patients will~     receive a standardized letter from their primary gastroenterologist describing the rationale~     for the study. Patients will be contacted by telephone by a member of the study team in order~     to arrange an appointment in the GCRC at the time of their regularly scheduled Transplant~     Clinic appointment in order discuss their potential participation in the study. Patients who~     give informed consent, will be interviewed using a standard interview questionnaire.~     Demographic and historical data relevant to the risk of VRE colonization will be collected~     during the interview. A sample will be obtained via rectal swab for culture. Rectal swabs for~     culture and collection of information on the standardized questionnaire will be repeated~     every six months while the patient is awaiting liver transplantation. When a patient~     undergoes liver transplantation, a culture will be obtained at the time of admission and~     weekly after post-operatively until discharge. All patients will be followed for 60 days~     after transplantation to assess several primary outcomes, including operative and~     post-operative complications, VRE infection and mortality. Rectal swabs will be the only~     procedure performed for the purposes of this study. Culture results will not be made~     available to the transplant team in order to avoid bias in clinical care. All data will be~     entered into an electronic database. GCRC statisticians will assist in the analysis of risk~     factors and outcome analysis.~   "
274155|NCT00005666|"~     This is a research study for patients with inoperable lung cancer called non-small cell lung~     cancer (NSCLC). Currently, the information from a radiological test, computed tomography (CT)~     scan of the chest, is used to design the best arrangement of radiation beams which will kill~     tumor cells and still spare the normal parts of lungs and other normal organs in the chest.~     The purpose of this study is to explore whether adding information from another radiological~     test, called positron emission tomography (PET), will improve the accuracy of the radiation~     beam arrangement designed to treat lung cancer. A PET scan is a way to picture the~     biochemistry of tissues and organs: of how tissues in the body take up glucose, a normal~     nutrient of the body. The researchers will attempt to create radiation treatment plans from~     PET images alone and compare differences between hypothetical plans and standard-of-care~     CT-based radiation treatment plans. Because there is honest uncertainty about the~     contribution of PET to radiation treatment planning, it is possible that there will be no~     difference between a CT-based treatment plan and one resulting from PET information. It is~     also possible that the addition of PET may result in a radiation beam arrangement that may~     better control lung cancer. The addition of PET may also result in treating less normal~     tissues, which may lower the risk of radiation side effects. This study will provide the~     preliminary data necessary to design a larger clinical trial that may define the role of PET~     in radiation treatment planning.~   "
274156|NCT00005665|"~     We hypothesize that ingested human recombinant interferon-alpha (hrIFN-a) will prolong the~     honeymoon period and enhance B cell survival in type 1 diabetes in a phase II randomized,~     placebo-controlled, double-blind clinical trial. We have demonstrated that ingested IFN-a~     prevents type 1 diabetes in the NOD mouse, prolongs the honeymoon period in newly diagnosed~     type 1 diabetics, and delays murine islet allograft rejection. The natural history of type 1~     diabetes is unique for a phase frequently referred as the honeymoon, a period in which the~     insulin need becomes minimal and glycemic control improves. The B cell (the insulin producing~     cell) partially recovers. However, as with all honeymoons, they end and the patient becomes~     completely insulin-deficient. The general consensus of the international diabetes community~     is to test potential preventive therapies for type 1 diabetes in newly diagnosed patients.~     Prolongation of the honeymoon as the reversal of the disease is considered a positive result.~      In this phase II randomized, double-blind, parallel-design clinical trial we will determine~     whether ingested (oral) human recombinant IFN-a will prolong the honeymoon period and~     increase counterregulatory anti-inflammatory cytokine(s).~      We will determine the safety and efficacy of 30,000 units ingested hrIFN-a vs placebo in~     eighty patients with newly diagnosed type 1 diabetes in a phase II trial for one year.~     Primary outcome measures will be a 30% increase in C-peptide levels released after Sustacal~     stimulation at 3, 6, 9, and 12 months after entry. Secondary outcome will be decreasing~     titers of islet cell antibodies (ICA). If successful, a larger and longer phase III trial of~     prevention of type 1 diabetes in high risk patients will be undertaken. We will also~     determine if ingested hrIFN-a increases IL-4, IL-10 or IFN-a production in peripheral blood~     mononuclear cells (PMNC) from patients with recent onset type 1 diabetes.~   "
274157|NCT00005664|"~     This study will evaluate patients with a variety of endocrine disorders in order to 1) learn~     more about conditions that affect the endocrine glands (glands that secrete hormones) and 2)~     to train physicians in endocrinology.~      Patients of all ages with endocrine-related conditions may be eligible for evaluation under~     this protocol. Those enrolled may be required to provide blood, saliva, urine or stool~     samples, and to undergo ultrasound examination of the thyroid gland, ovaries or testes,~     adrenal glands or other parts of the body. Laboratory or X-ray studies may be done for~     diagnostic or treatment purposes. In some cases, patients will receive medical or surgical~     treatment for their disorder. Patients and family members of patients with a hereditary~     disorder may be asked to provide a blood sample for genetic analysis.~   "
274158|NCT00005660|"~     This is a continuing study which evaluates the long-term safety and efficacy of oral~     acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of~     keratinization, multiple basal cell carcinomas and other retinoid responsive diseases.~   "
274159|NCT00005658|"~     This study will test the safety and effectiveness of the amino acid glycine in treating~     psychotic disorders in children. The drug will be given as an adjunct (in addition) to the~     patient's current antipsychotic medication.~      Children age nine to 18 with schizophrenia or schizoaffective disorder whose symptoms began~     before age 13 may be eligible for this 10-week study. Patients will be hospitalized during~     the course of the trial. Weekend visits home may be permitted.~      Children enrolled in the study will be evaluated during a two-week pre-treatment period with~     written tests for IQ and academic functioning and with a magnetic resonance imaging (MRI)~     scan of the brain. For the MRI, the child lies on a table that slides into a large~     donut-shaped machine with a strong magnetic field. This procedure produces images of the~     brain that may help identify brain abnormalities in schizophrenia that develop in childhood.~      During the eight-week treatment phase, patients will receive glycine powder dissolved in~     water once a day, in addition to their other antipsychotic medications. They will undergo the~     following additional procedures during the course of treatment:~        1. Comprehensive psychiatric examination~        2. Blood pressure and pulse monitoring once a week~        3. Blood tests every other week - About one ounce of blood is drawn per week to measure~          glycine levels~        4. Eye movement study at week eight - Using a technique called infrared oculography,~          special detectors measure infrared light reflected off the child's eyes while he or she~          watches a moving square on a video monitor.~        5. Lumbar puncture (spinal tap) once during the study - About one-half ounce of~          cerebrospinal fluid (the fluid surrounding the brain and spinal cord) is withdrawn~          through a needle placed in the lower part of the spine for analysis of brain chemicals.~      Patients who respond well may continue to receive glycine treatment through their referring~     physician after the study is completed.~      NIMH will follow patients by phone every six months and with visits at two-year intervals.~   "
274160|NCT00005657|"~     The diverse clinical syndromes associated with hepatitis C underscore the multifactorial and~     polygenic nature of HCV infection. Both viral and host factors likely contribute to~     variations in infection outcome, disease susceptibility and progression, and treatment~     response. This protocol will focus on the immunogenetics of HCV infection. Various candidate~     genes, most of them related to host immune response in microbial infection, have defined~     genetic polymorphisms that have been associated with variable manifestations of infections~     including malaria, tuberculosis, leprosy, AIDS and hepatitis B. In this proposal, we plan to~     collect peripheral blood mononuclear cells as a source of DNA from approximately 1500~     patients with HCV infection, analyze genetic polymorphisms of various candidate genes in~     association with viral clearance, disease progression or treatment response, and characterize~     the functional consequences of these polymorphisms in patients with well-defined clinical~     sequelae of HCV infection. We will also collect blood from patients with other forms of liver~     diseases (approximately 300) or normal volunteers (approximately 200) as controls. By~     identifying relevant host factors genetically and investigating their molecular interactions~     with HCV, we may gain additional insights into HCV pathogenesis and uncover new potential~     targets for vaccine development and treatment intervention.~   "
274161|NCT00005655|"~     The purposes of this study are fourfold. It will 1) determine what dose of interleukin-12~     (IL-12) and interleukin-2 (IL-2) combination therapy can be given safely to patients with~     advanced cancer; 2) evaluate the side effects of this treatment; 3) examine how the body~     handles this drug combination; and 4) determine whether and how the therapy may cause the~     immune system to stop or slow tumor growth.~      IL-2 is an approved drug for treating melanoma and kidney cancer. IL-12 is an experimental~     drug that has shown anti-cancer activity in animals, shrinking tumors and slowing their~     growth. Animal studies suggest that given together, the drugs may be more effective against~     cancer than either one singly.~      Patients 18 years of age and older with advanced solid-tumor cancers (kidney, breast, lung,~     sarcomas and others) that do not improve with standard treatment may qualify for this study.~     Candidates will have a physical examination, including blood and urine tests,~     electrocardiogram (EKG) and echocardiogram, DTH skin test (to test the function of the immune~     system), chest X-ray and lung function tests to determine eligibility. Bone marrow biopsy and~     imaging procedures such as CT and MRI scans may also be required. Patients over 50 years old~     will also undergo exercise stress testing.~      Treatment will consist of four courses of IL-2 and IL-12. On days one and nine of each~     course, patients will receive three doses (one every 8 hours) of IL-2 intravenously (through~     a vein). On days two, four, six, 10, 12 and 14, they will receive IL-12 intravenously. This~     will be followed by a recovery period from days 15 through 35. This regimen will be repeated~     for another three cycles; patients who show benefit without severe side effects may continue~     for additional cycles. Treatment for the first cycle will be administered in the hospital. If~     the drugs are well tolerated, additional therapy may be given on an outpatient basis.~      A biopsy (removal of a small sample of tumor tissue) will be done at the beginning of the~     study, after completing the first treatment cycle, and possibly again when the cancer slows,~     stops or gets worse, or if the patient leaves the study. These tumor samples will be examined~     to evaluate the effects of treatment. Several blood samples also will be collected during the~     course of treatment to monitor immune system effects. A device called a heparin lock may be~     put in place to avoid multiple needle sticks.~   "
274162|NCT00005654|"~     OBJECTIVES:~      I. Determine whether reduction of serum insulin levels by metformin increases ovulatory~     response to clomiphene or spontaneous ovulation in obese women with polycystic ovary~     syndrome.~   "
274163|NCT00005652|"~     OBJECTIVES: I. Determine the response rate and response duration to rituximab in patients~     with immune thrombocytopenic purpura.~      II. Evaluate the toxicity associated with this treatment regimen in these patients.~      III. Evaluate the alteration in antiplatelet antibody with this treatment regimen in these~     patients.~   "
274164|NCT00005650|"~     OBJECTIVES:~      I. Characterize the clinical presentation of patients with primary ciliary dyskinesia.~      II. Identify the genetic mutations associated with this disease.~   "
274165|NCT00005575|"~     Approximately 75,000-150,000 patients each year in the United States undergo intensive~     cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings.~     These patients often have high levels of disability and suffering and account for~     $250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence~     from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of~     training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term~     reductions in pain intensity. However, no studies have compared the effects of these two~     treatments on measures of pain, suffering, and disability at post-treatment and over a~     one-year follow-up period.~      Our investigation is a 16-week, randomized controlled outcome study of these interventions~     and their respective placebo control procedures. One hundred and sixty patients are being~     recruited for this study. We will assess the effects of our interventions on patients' pain~     levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month~     follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our~     treatment effects as well as their statistical significance.~   "
274180|NCT00005102|"~     OBJECTIVES:~      I. Determine the pattern of immunologic reconstitution in patients with T-cell compromise due~     to DiGeorge syndrome or velocardiofacial syndrome.~      II. Determine any correlation between immunologic function in these patients and chromosome~     22 deletion breakpoints.~      III. Determine presence of sustained immunologic compromise in older patients.~   "
274181|NCT00005101|"~     OBJECTIVES:~      I. Determine the possible causes of bone loss in premenopausal or perimenopausal women.~   "
275020|NCT00000523|"~     To assess exercise training adherence and compliance over two years in subjects who were at~     relatively high risk for coronary artery disease. Also, to test strategies for improving~     adherence and compliance and to assess the effect of exercise training.~   "
274166|NCT00005571|"~     This study will evaluate the safety and effectiveness of the experimental drug h5G1.1-mAb in~     treating patients with dermatomyositis. This disease, which causes skin rash, muscle~     weakness, and sometimes various other symptoms, may be due to an immune system abnormality.~     Drugs currently used to treat dermatomyositis, such as prednisone and various anticancer~     drugs, often have serious side effects and may not work in all patients. h5G1.1-mAb is a~     genetically engineered antibody that blocks the activity of certain proteins involved in the~     immune reaction that produces inflammation.~      Patients age 18 years and older who have had dermatomyositis for at least 6 months and who~     have not improved with prednisone or other therapies, or who cannot tolerate prednisone or~     other therapies, may be eligible for this 12-week study. Candidates will have a history and~     physical examination, including blood and urine tests, throat culture, and muscle strength~     testing. Participants will be randomly assigned to receive either h5G1.1-mAb or placebo (an~     inactive substance). The drug or placebo will be given intravenously (through a thin tube~     inserted into a vein) once a week for five doses and then every other week for two more~     doses.~      Participants will undergo the following additional tests at various intervals during the~     study as follows:~        1. Complete physical examination ( visit 9)~        2. Blood and urine tests (various intervals)~        3. Muscle strength testing, assessment of ability to perform daily tasks, and completion of~          questionnaire regarding functional abilities (visits 2, 6 and 9)~        4. Ultrasound imaging of muscle (during certain muscle exercises) (visits 2, 6 and 9)~        5. Electrocardiogram (EKG) (visits 2 and 9)~        6. Throat swab (culture) (visit 6)~        7. Examination and photography of skin lesions (visits 2 and 9)~        8. Skin biopsy - removal of small sample of skin tissue under local anesthetic (visits 2~          and 9)~        9. Magnetic resonance imaging (MRI) scan of muscles (visits 2 and 9)~       10. Possible muscle biopsy - removal of small sample of muscle tissue under local anesthetic~          (visits 2 and 9).~   "
274167|NCT00005569|"~     This study will evaluate the effects of a protein called secretory leukocyte protease~     inhibitor (SLPI), on skin wound healing. Produced naturally by the body, SLPI modifies levels~     of elastase, a substance that breaks down the skin. Older people are at greater risk of~     impaired wound healing, with increased elastase activity and inflammation. In addition, men~     heal more slowly than women. Delayed healing is associated with infection and pain and can~     lead to the development of chronic non-healing skin wounds.~      Healthy men and women between 60 and 80 years old who wish to participate in this study will~     have a brief history and physical evaluation to determine their eligibility. Those enrolled~     will be randomly assigned to receive a gel form of SLPI applied topically (on the skin~     surface) to a skin wound or a placebo (a look-alike gel with no active ingredient).~     Participants will undergo the following procedures:~      First visit - The skin will be numbed with a local anesthetic and two small (4 mm) wounds~     (about the size of a pencil eraser) made in each upper arm. The drug or placebo will be~     applied to the wound and gauze placed over it. Two blood samples (20 ml and 7 ml) will be~     drawn an hour apart to determine blood levels of SLPI.~      Second visit - The day after the first visit, the wound dressing will be removed and the~     participant will be evaluated for pain at the wound site, allergic reactions or infection. A~     blood sample (7 ml) will be taken.~      Third visit - The wounds will be examined and photographed to evaluate healing. In addition,~     the strength of the wound may be assessed by means of a vacuum system placed on the skin.~     (This may cause a tingling sensation over the wound.) A piece of all four wounds will be~     removed after the skin has been numbed and a dressing applied.~      Fourth visit - The wounds will be examined for healing and the dressing removed.~   "
274168|NCT00005567|"~     In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in~     infants between the ages of 1 and 12 months. The etiology of SIDS is still not clear although~     a number of risk factors have been identified. Sleeping on the stomach has been identified as~     a major risk for SIDS. The rates of SIDS have dropped substantially in countries in which the~     usual sleep position has changed from the stomach to the side or back. Back sleep has been~     shown to be the most stable and safest position. The American Academy of Pediatrics now~     recommends the back sleeping position for all healthy infants. Since the American Academy of~     Pediatrics began advocating the back sleep position, the incidence of SIDS has decreased by~     more than 40% in this country. However, the decrease has not been uniform across segments of~     the population. Black infants continue to have a higher rate of SIDS compared with other~     groups. This discrepancy could be related to infant sleep position practices. Several studies~     have shown that infants born to low income, minority, inner-city families were more likely to~     be placed on the stomach to sleep. Education appears to influence choice of sleep position~     and may explain, at least to some degree, the difference in choice of sleep position among~     certain groups. We believe that uniform education of parents will influence the sleep~     position that parents choose for their baby. We will undertake this initial study to document~     what parents choose to do with their infants regarding sleep position and why they make these~     choices so that we can improve our educational approach.~   "
274169|NCT00005566|"~     The purpose of this project is to pilot a new scale, The Desperation Scale, in a sample of~     young adolescents (aged 10-16) seen in the pediatric emergency room who require a psychiatric~     consultation. The proposed study is designed to assess the psychometric properties of this~     new scale and to provide information about the cognitive state of young suicidal individuals.~     It is hypothesized that this scale will be able to discriminate between those who are~     suicidal and those who are not. Data obtained in this pilot study will provide information~     about the usefulness of the construct of desperation and will guide future projects aimed at~     the assessment and treatment of suicidal individuals. The use of cognitive factors to predict~     suicidal behavior is appealing because they allow the clinician to tap into an individual's~     perception of his/her life circumstances. However, we believe the popular conceptualization~     of suicide as a result of hopeless thinking ignores an important aspect of suicidal~     behavior-the motivation to escape. We propose that a model of suicidal behavior that includes~     escape motivation, which we call the desperation model, will be better able to predict~     suicide than existing measures. We conceptualize desperation as consisting of three core~     elements: a sense of entrapment, feelings of anxiety/agitation, and a sense of time urgency.~     The current pilot study will test a 35-item scale that assesses these three elements of~     desperation. A pilot study of the Desperation Scale is currently being conducted at the~     Cornell University Medical Center (P.I. P.M. Marzuk) with depressed, adult inpatients. Our~     study is original in its use of the scale with an adolescent population and its focus on~     patients in the emergency room, when they are presumably in a purer suicidal state. It is~     hypothesized that those who are admitted to the emergency room for recent suicidal behavior~     will endorse feelings of entrapment, anxiety, and time urgency.~   "
274170|NCT00005119|"~     Osteoporosis has become one of the most widely recognized disorders of our times affecting an~     estimated 25 million women in this country. Recent evidence has suggested that premenstrual~     syndrome (PMS) is associated with a calcium deficiency state and bone loss. This may place~     premenopausal women at greater risk for osteoporosis. An entity such as PMS may be an~     important physiological marker of a calcium disturbance. The purpose of this investigation is~     to understand more completely the extent to which calcium balance is disturbed in severe PMS~     or Premenstrual Dysphoric Disorder (PMDD) by utilizing new tools to assess calcium and bone~     turnover. The long term objective is to elucidate the pathophysiology of PMDD or severe PMS~     as it relates to calcium hormones and bone markers. The experimental design involves the~     comparison between women witn severe PMS and asymptomatic controls.~   "
274182|NCT00005100|"~     OBJECTIVES: I. Compare growth hormone (GH) levels at baseline and after glucose suppression~     measured with both a polyclonal radioimmunoassay and a highly sensitive immunoradiometric~     assay (IRMA) in patients with acromegaly and normal volunteers.~      II. Measure the levels of IGF-I and its binding protein, IGFBP-3, in these cohorts.~      III. Determine any correlation between levels of IGF-I and IGFBP-3 and GH suppressibility as~     assessed by sensitive IRMA.~      IV. Determine if patients who demonstrate biochemical features of mild GH excess are at risk~     for progression to active disease.~   "
274183|NCT00005098|"~     OBJECTIVES:~      I. Establish cell lines from patients with alpha 1-antitrypsin deficiency in order to examine~     genetic traits that predispose to liver injury.~   "
274171|NCT00005117|"~     There is significant evidence that HMG-CoA reductase inhibitors, a commonly used class of~     cholesterol lowering medications, reduce the risk of death from coronary disease. Although~     these medicines lower cholesterol levels, other studies suggest that they have an additional~     effect on improving blood vessel functioning. It has also been shown that consumption of a~     fatty meal temporarily alters blood vessel functioning, causing endothelial dysfunction. This~     study will examine if pravastatin, an HMG-CoA reductase inhibitor, improves blood vessel~     functioning after a fatty meal. We plan on enrolling 32 subjects, aged 18-40 years, who are~     healthy with no history of diabetes, smoking, high blood pressure, or heart disease. These~     subjects will be randomly assigned to initially receive four days of pravastatin or an~     inactive substance, and then crossed over to the other group. Blood vessel functioning will~     be monitored by a technique called flow mediated vasoactivity, which uses ultrasound~     measurement of the forearm artery and its response to temporary occlusion. This primary~     measure of flow mediated vasoactivity will be done before and after consumption of a fatty~     meal. We hope to show that treatment with pravastatin prevents the blood vessel dysfunction~     known to occur after a high fat meal. Secondary outcomes will include measurement of~     endothelin-l, a mediator of blood vessel functioning, and assessment of changes in lipid~     profiles. If pravastatin does prevent endothelial dysfunction in this setting, it could lead~     to further studies about their use in more acute medical settings, including heart attacks or~     strokes.~   "
274172|NCT00005112|"~     Cystic Fibrosis (CF) is the most common lethal genetic disorder in America. Previous studies~     by our group and others have shown that human recombinant growth hormone (GH) improves height~     velocity, weight velocity, lean body mass (LBM) and pulmonary function. These positive~     results have prompted us to ask further questions regarding GH use in CF including: a) Do~     patients with better baseline body weight and pulmonary function derive more benefit from~     treatment than those with worse weight and pulmonary function?, b) Does GH use improve the~     patient's quality of life?, c) Once GH is discontinued, are the positive effects sustained?~     We hypothesize that GH treatment in CF patients will improve their clinical status and their~     quality of life. We further hypothesize that these effects will be present regardless of~     baseline body weight or pulmonary function, and that positive outcome will be sustained for~     at least one year after GH treatment is discontinued. To test our hypothesis, we will recruit~     40 prepubertal children from five CF centers across the United States (8 per center).~     Patients will be randomly assigned to receive treatment with GH (0.3mg/kg/wk) during either~     the first or the second year. All subjects will be seen every three months. We will evaluate~     the following parameters every three months: 1) height, height velocity and Z-score, 2) body~     weight and weight velocity. Every six months we will measure: 1) lean body mass utilizing~     DEXA, 2) pulmonary function, including measurement of respiratory muscle strength (peak~     inspiratory and peak expiratory pressure), 3) quality of life (QOL), quantitated from QOL~     forms specific for CF (The Cystic Fibrosis Questionnaire). After one year of study,~     subjects will cross-over to the other treatment arm. This 24 month study will allow us to~     statistically compare outcome measures in 20 treated and 20 nontreated subjects from multiple~     centers, and will allow us to assess sustained effect in the 20 subjects who receive GH~     during the first year, by comparing their results to results obtained during the year post~     treatment.~   "
274173|NCT00005116|"~     Depression is one of the most common emotional problems among youths with insulin dependent~     diabetes mellitus (IDDM). It has been shown that depression in youths with IDDM lasts a while~     and may have a role in later complications of the medical condition. And yet, there are no~     psychological interventions appropriate for such youngsters. The purpose of this study is to~     modify a treatment called ''Contextual Psychotherapy'' (that has been developed for depressed~     youngsters) in order to address special needs of depressed youths with IDDM, and to ''pilot~     test'' the treatment. The youngsters to be recruited are those being cared for at the~     Diabetes Clinic of the Children's Hospital of Pittsburgh. The treatment includes a 3- month~     phase (16 sessions), followed by a 3-month ''booster'' phase (3 sessions), and two later~     follow-up evaluations.~   "
274174|NCT00005110|"~     Long term use of bronchodilators in CF is beneficial to the improvement of pulmonary function~     and symptoms. This study is investigating the long-term benefit of administration of the drug~     Salmeterol, a bronchodilator. Salmeterol will be compared to albuterol or placebo. The~     medication will be inhaled twice a day for 6 months.~   "
274175|NCT00005108|"~     This study will determine the effects of hormone replacement therapy (estrogen alone or~     estrogen and progesterone) on the walls of arteries in postmenopausal women. Inflammation and~     stiffness of artery walls are two risk factors for atherosclerosis-deposits of fatty~     substances (plaques) that can block the vessel, causing a heart attack or stroke. Estrogen~     raises the levels of certain substances in the blood that cause vessel inflammation and~     lowers the levels of others. This study will measure the net effects of estrogen on artery~     wall inflammation and stiffness.~      Postmenopausal women in good health may participate in this study. Volunteers will be~     screened for eligibility with a complete medical history, heart examination, and blood tests.~     Participants will be randomly assigned to receive either: 1) hormone therapy (estradiol 2 mg~     daily alone for women who have had a hysterectomy or estradiol plus micronized progesterone~     200 mg daily for women with an intact uterus); or 2) placebo (look-alike pills that contain~     no active drug). Women in both groups will take pills for 3 months, then no pills for 1~     month, and then will crossover to the alternate therapy for 3 months (i.e., those in the~     original placebo group will take hormones, and those in the hormone group will take placebo).~     At the end of each 3-month treatment period, participants will undergo the following~     procedures to assess blood vessel inflammation and stiffness:~        1. Blood tests - 60 cc (about 2 ounces) of blood will be drawn to measure levels of~          hormones, cholesterol, and substances in the blood that indicate inflammation of the~          vessels.~        2. Ultrasonography - an ultrasound probe will be applied gently on the neck to image the~          right and left carotid arteries (arteries in the neck that lead to the brain). During~          the procedure, the heart's electrical activity will also be monitored with an~          electrocardiogram and a blood pressure cuff will be wrapped around the arm to obtain~          blood pressure measurements every 5 minutes.~        3. Magnetic resonance imaging (MRI) - Images of the carotid arteries are taken while the~          volunteer lies on a table in a narrow cylinder containing a magnetic field. A padded~          sensor called an MRI coil is placed over the neck and earplugs are placed in the ears to~          muffle the loud noise of the machine during scanning. During the second half of the~          exam, gadolinium is injected through a catheter (thin, flexible tube) inserted into a~          vein. Gadolinium is a contrast agent that is used to brighten the scan images.~      Information from this study will increase knowledge about the effects of estrogen on vessel~     wall inflammation. As such, it may be used in the future to help guide decisions about~     chronic hormone replacement therapy in postmenopausal women.~   "
274176|NCT00005107|"~     This study is to determine whether a compound, nitric oxide, made within the body, is the~     factor responsible for the changes in blood pressure and renal (kidney) functions that may~     occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes~     poor liver function) will be eligible to participate. A group of healthy subjects will also~     be studied to compare the effects of the treatment to patients with cirrhosis and to confirm~     safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be enrolled~     in the study.~   "
274177|NCT00005105|"~     OBJECTIVES:~      I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead~     to relative insulin-like growth factor-I insensitivity and produce intrauterine growth~     retardation in children.~   "
274178|NCT00005104|"~     OBJECTIVES:~      I. Determine whether reduction of serum insulin levels by metformin increases ovulatory~     response to clomiphene citrate in women with polycystic ovary syndrome.~   "
275021|NCT00000522|"~     To compare the effects of nonpharmacologic therapy alone with those of one of five active~     drug regimens combined with non-pharmacologic therapy, for long- term management of patients~     with mild hypertension.~   "
274184|NCT00005015|"~     THIS STUDY HAS BEEN DISCONTINUED.~      The study is designed to evaluate the safety and efficacy of fluoxetine for treating children~     and adolescents with Bipolar Disorder who are experiencing an episode of major depression~     while being treated with a mood stabilizer. The study involves a 2-week assessment period.~     Patients who are on stable, therapeutic doses of lithium or valproate and continue to have~     depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who~     respond favorably to treatment will be followed openly for an 18-week continuation phase.~   "
274185|NCT00005014|"~     This study is designed to determine the effectiveness of risperidone, a drug treatment for~     the interfering symptoms of Autistic Disorder in children and adolescents between the ages of~     5 and 17. Between 100 and 120 patients will be participating in this research study at five~     academic medical centers in the United States. The primary aim of the treatment is to reduce~     impairing behavioral symptoms such as aggression, explosive outbursts, or self-injurious~     behavior, without significant side effects. A secondary aim is to evaluate possible~     improvement in the level of social relatedness, attention, motor coordination, and short-term~     memory.~      This study is a placebo-controlled, double-blind study (neither the investigators nor~     patients know if the treatment being given is risperidone or an inactive substance, placebo).~     Patients will be asked to participate for 6 to 8 months. For the first 8 weeks, patients will~     receive either risperidone or placebo, randomly chosen. At the end of the 8 weeks, those~     patients who have improved and were on risperidone will be asked to continue on this~     medication for another 4 months. The last two months of the study are again double-blind~     (neither patients nor investigators know treatment). Patients will either continue~     risperidone treatment or be gradually tapered from risperidone (placebo-substitution). This~     blinded discontinuation phase will last 2 months during which patients will be closely~     monitored for recurrence or worsening of symptoms. Patients who have been treated with~     placebo in the first 8 weeks of the study and have not improved will be treated with~     risperidone. Weekly visits are required for the first 8 weeks of the study, monthly visits~     for the following 4 months, and weekly visits during the last 2 months of the study.~   "
274186|NCT00005013|"~     The purpose of this trial is to study the acute efficacy and safety of a standardized extract~     of the herb Hypericum perforatum (St. John's Wort), called hypericum for purposes of this~     trial, in the treatment of patients with major depression.~      Clinical depression is a serious medical disorder that can be debilitating and can lead to~     suicide. There is growing public interest in claims that hypericum may be an effective~     treatment for depression. Although it is widely prescribed in Europe, no studies of its~     long-term use have been conducted, and published studies have treated different types of~     patients and have used several different doses. The toxicity and side effects of hypericum~     appear to be substantially less than those of standard tricyclic antidepressant medications,~     and thus hypericum may be more acceptable to patients. In addition, the cost is significantly~     less than standard antidepressant medications. Published studies assessed acute efficacy and~     lasted between 4 and 12 weeks (most being 4-6 weeks). The longer-term effects of hypericum~     have not been evaluated. There is a need for a large-scale, controlled clinical trial to~     assess whether Hypericum has a significant therapeutic effect in patients with clinical~     depression.~      Patients are assigned randomly (like tossing a coin) to receive St. John's wort, Sertraline~     (Zoloft), or a placebo (sugar pill) for 8 weeks. This is a double-blind study, meaning~     neither the patient nor the doctor will know which treatment is being assigned. Patients who~     respond well to the treatment will continue on the assigned treatment for an additional 4~     months. Patients will have regular follow-up visits to monitor their symptoms and any side~     effects they experience.~   "
274187|NCT00005011|"~     This study investigates the effects on symptoms of combined treatment with estrogen and~     progesterone in women with severe premenstrual syndrome (PMDD).~      Studies indicate that women with PMS experience improvement in symptoms following treatment~     with leuprolide acetate, when estrogen and progesterone levels are low. Women with PMS, but~     not women without the disorder, experience a return of symptoms within approximately a week~     after re-exposure to either estrogen or progesterone. The cause of this hormone-induced~     depression remains unclear. It is not known whether this depressed mood is due simply to the~     change in the levels of estrogen and progesterone and whether it would remit following~     continued exposure to stable levels of estrogen and progesterone. This study will determine~     whether the maintenance of stable hormone levels will prevent mood disturbances in women with~     PMS.~      Participants in this study will receive leuprolide acetate injections once a month for up to~     6 months. After 2 months, women whose symptoms have improved will receive a skin patch~     containing either estrogen or placebo (an inactive substance) and will be asked to take daily~     suppositories containing either progesterone or placebo. Women whose symptoms of PMS do not~     respond to leuprolide treatment after 2 months will end the study and be offered other~     treatment. Participants will be seen by a nurse in the clinic every two weeks and will fill~     out ratings and have blood drawn to measure hormone levels.~   "
274188|NCT00005007|"~     This study will determine if the drug etanercept, also called Enbrel, is effective in~     producing and maintaining remission (reduction of disease symptoms) of Wegener's~     granulomatosis (WG). Etanercept blocks the action of tumor necrosis factor-alpha, a substance~     that may be involved in inflammatory conditions such as WG. Eight clinical centers around the~     United States will enroll 181 people who have WG. Patients will have an equal chance to~     receive either etanercept or placebo (inactive treatment). We will treat patients with~     standard medications for WG in addition to either etanercept or placebo. We will treat all~     patients with tapering doses of corticosteroids.~      After the patients' disease is controlled (in remission), we will reduce the dosages of the~     standard medications to lower the risk of side effects associated with these drugs. During~     the study, we will collect and save blood and tissues samples from patients and use the~     samples to address other medical questions, such as the cause of WG and factors that lead to~     disease progression.~   "
274218|NCT00004729|"~     Twenty to thirty percent of children with epilepsy continue to suffer from seizures, even~     when treated with currently available anticonvulsant medications. Children with~     Lennox-Gastaut Syndrome (LGS) are particularly handicapped by atonic-myoclonic seizures.~     Preliminary data suggest that even when other medications have failed, these seizures may~     respond rapidly and dramatically to a high-fat-low-carbohydrate ketogenic diet. The purpose~     of the study is to assess if the classic ketogenic diet is efficacious in reducing seizure~     frequency, medication toxicity, and improves quality of life.~   "
274189|NCT00005006|"~     This study investigates the effectiveness of parathyroid hormone (PTH) in combination with~     alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are~     using alendronate because it may help protect patients against any possible harmful effects~     of PTH in cortical bone such as the long bones or hip. We are testing two different treatment~     schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of~     every 6 months in a cyclical fashion. The entire study is 21 months long; the active~     treatment period is 18 months with a 6-month followup period.~      The main effects we will look for in this study are changes in body chemicals that are signs~     of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We~     will randomly assign all study participants, who are women aged 50 and over, to either stay~     on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for~     3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily~     alendronate.~   "
274190|NCT00005005|"~     This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and~     alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to~     treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We~     will treat the study participants either with PTH and alendronate, alendronate alone, or PTH~     alone. We will determine the effects of these treatments by looking for changes in bone~     mineral density in the hip and spine.~   "
274191|NCT00005004|"~     This research trial will study discourse processing-that is, how the brain processes the~     meaning of language. It will examine, for example, how words and sentences are interpreted in~     cases where more than one meaning is possible. The study will include two parts:~        1. An investigation of the role of the prefrontal cortex of the brain in discourse~          processing will compare test performance of patients with prefrontal cortex damage with~          that of healthy age-matched normal volunteers.~        2. An investigation of the role of aging in discourse processing will compare test~          performance of young healthy subjects (18 to 40 years old) with older healthy subjects~          (41 to 80 years old).~      All study candidates-both normal volunteers and patients with brain damage-must be at least~     18 years old, speak English as their native language, have a high school degree or equivalent~     (GED), read on a minimum fourth grade level and be right-handed.~      Study candidates who have central nervous system disease, dysfunction or trauma will have a~     routine history and neurological examination. They will also undergo neuropsychological~     testing if they have not already done so. Patients with neurological damage who have not had~     a magnetic resonance imaging (MRI) scan within six months or a year will be asked to undergo~     this procedure.~      Study participants will take verbal or written tests; sit in front of a computer screen and~     press computer keys in response to what they are shown; answer questions from an examiner,~     which may be tape-recorded; and fill out questionnaires. There will be rest breaks between~     tasks. The studies will be spread over three to four days, with sessions lasting from 30~     minutes to three hours.~   "
274192|NCT00005003|"~     Some functions are generally controlled by the right side of the brain and others by the~     left. One of the most easily observed examples of this lateral specialization of the brain~     is handedness-that is, a person's preference for using either the right or the left hand.~     This study will try to determine how the genetic component of handedness is inherited. It~     will test the theory that a single gene is involved in determining handedness and will try to~     locate the gene.~      Families with at least two left-handed siblings aged eight years or older and at least one~     right-handed parent are eligible to participate in this study.~      The left-handed siblings and both parents will fill out a brief questionnaire on hand usage,~     obtain a tissue sample taken from inside the cheek, and return the questionnaire and the~     sample by mail to the study researchers. The tissue sample will be used for DNA gene mapping.~      Participants will be given a kit and instructions for obtaining the sample, along with~     mailing envelopes. Cheek swab sampling basically involves using a small brush to gently brush~     a layer of cells off of the inner wall of the cheek and then dropping the brush tip into a~     preservative.~      The information gained from this study may provide insight into aspects of brain development~     that can be of medical benefit in the future.~   "
274193|NCT00004997|"~     The 5 q minus syndrome is a condition that occurs due to a missing segment of chromosome 5 in~     the normal genetic make-up of the cells responsible for forming blood cells. The condition~     causes patients to have the inability to make blood normally. Many patients with this~     syndrome need transfusions of red blood cells, platelets, and/or white blood cells. Low~     levels of platelets may cause the patient to bleed easily and low levels of whit blood cells~     make the patient susceptible to infections. A small number of patients with 5 q minus~     syndrome develop leukemia, which is often untreatable with chemotherapy.~      Researchers believe that one of the genes missing in 5 q minus syndrome is the gene~     responsible for making folic acid active in the body. Folic acid is a vitamin required for~     normal blood production.~      The purpose of this study to test the effectiveness of a drug called leucovorin for the~     treatment of 5 q minus syndrome. Leucovorin is an active form of the vitamin folic acid that~     does not require the missing genes to activate it.~      Patients participating in this study may or may not improve with leucovorin treatment.~     However, the study will improve researchers understanding of the disease and may lead other~     potential therapies for the disease.~   "
274213|NCT00004734|"~     A stroke occurs when part of the brain is damaged from lack of normal blood supply. This may~     result in difficulty with feeling, speech, muscle strength or coordination, movement,~     thinking, or other brain functions. Having a stroke increases the risk of another stroke~     occurring in the future. Higher blood levels of a natural chemical known as homocysteine may~     contribute to hardening of the arteries in the brain or heart and increase the risk of stroke~     or heart attack. Folic acid, vitamin B6 (pyridoxine), and vitamin B12 (cyanocobalamin) may~     lower blood levels of homocysteine and reduce the risk of having another stroke or a heart~     attack.~   "
274214|NCT00004733|"~     The ELLDOPA study is a controlled clinical trial in patients with newly diagnosed PD to~     determine the optimal timing and dosing with levodopa (Sinemet or its generic equivalents).~   "
274219|NCT00004728|"~     The purpose of this study is to determine whether aspirin or warfarin is more effective in~     preventing stroke in patients with intracranial stenosis.~   "
275022|NCT00000521|"~     To examine the effects of nutritional intervention on the rate of rise of blood pressure in~     late childhood and early adolescence.~   "
274194|NCT00004996|"~     This study will compare the structure, chemical composition and other characteristics of skin~     and blood in people with and without parasitic infections. Cell samples will be taken from~     blisters produced by suction blistering. This study may provide new information about the~     interactions between parasites and the immune system that could lead to better treatments for~     these infections.~      Normal volunteers and patients with acute helminth (a type of parasite) infections aged 18~     years older may be eligible for this study. Following a medical history and physical exam,~     participants will undergo suction blistering to provide cells needed for study. A suction~     blister device is attached to the skin of the thigh. A heating element in the device heats~     the skin to speed blister formation. (This will feel only a slightly warm.) The device is~     removed after about two hours, when the blisters have formed. The blister tops are removed~     with sterile scissors. The blistered areas are then treated with special dressings to promote~     healing and the participant is discharged with further wound care instructions. A small~     amount of blood (around four tablespoons) may be drawn to compare chemicals in the blood with~     chemicals in the blister fluid. Participants will be contacted by telephone over the next 72~     hours to check on healing. Further follow-up will occur by phone at 6 months and 1 year.~      Up to 60 blisters may be produced over a one-year period (in three separate sessions every~     six months) with no more than 20 raised per session....~   "
274195|NCT00004994|"~     This study will examine the quality of life of patients undergoing bone marrow~     transplantation to treat a blood disease. It will look at how this therapy affects many areas~     of life, including for example, personal relationships, work, and general emotional state.~     The information gained may lead to improved ways of dealing with problems that may arise~     before or during treatment.~      Patients receiving bone marrow stem cells donated by a family member may participate in this~     study. They will be interviewed before treatment begins and will complete questionnaires at~     the following intervals:~        1. day of admission to the hospital~        2. day of the transplant~        3. 30 days after the transplant~        4. 100 days after the transplant~        5. 1 year after therapy~        6. 2 years after therapy~      All questionnaires to be completed after discharge from the hospital will be scheduled during~     a regular follow-up visit. Each questionnaire takes about 15 to 20 minutes to complete. The~     information provided is confidential and will not be shared.~   "
274196|NCT00004993|"~     Glucocorticoids are potent anti-inflammatory and immunosuppressive agents. However, prolonged~     use of these potent agents results in severe bone loss and osteoporotic fractures.~     Parathyroid hormone (1-34), when given as a daily injection has been found to dramatically~     increase bone mass in osteoporotic animals and postmenopausal women. The purpose of this~     study is to determine whether 2 years of daily PTH (1-34) injections will increase bone mass~     and reduce the development of new fractures. In addition, we will follow the study subjects~     for 2 more years to determine which type of anti-resorptive agent is required to maintain the~     newly formed bone.~      We are enrolling postmenopausal women that are on chronic corticosteroid therapy (prednisone~     etc.) and have bone loss (osteopenia by DXA) to be a part of this four-year-long study. The~     patients will receive two-year therapy with either PTH (1-34) or placebo, and for the second~     part of the study subjects receive either estrogen and placebo or alendronate and placebo. We~     will measure bone gain by standard bone densitometry, special x-rays of the spine and hip,~     and serum and urine bone markers.~   "
274197|NCT00004992|"~     The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can~     Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or~     delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at~     twenty-five medical centers in the United States. It is sponsored by the National Institute~     of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other~     Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle~     intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in~     persons with impaired glucose tolerance (IGT). Each person in the study will be followed for~     3 to 6 years.~   "
274198|NCT00004991|"~     The purpose of this study is to gain a better understanding of the brain's activity and~     organization in the development of speech disorders. It will compare brain activity in people~     with normal speech development with those who stutter or who have a phonological disorder (a~     deficit in how the brain processes speech sounds).~      Stuttering and phonological disorders emerge during the critical period of speech development~     between 2.5 and 12 years of age. During this period, the brain is much more adaptable for~     speech development than it is after puberty. This study will examine how the brain~     organization for speech production and perception develops normally during the critical~     period and how the normal pattern is altered when stuttering and phonological disorders~     become chronic problems, persisting throughout life.~      Volunteer adults and children with and without speech disorders may participate in this~     study. Eligibility screening will include a brief neurological and physical examination and~     tests to determine normal speech or a speech disorder. The speech testing will be videotaped.~     The subject will speak aloud, describe pictures, recall words or numbers, imitate speech~     sounds and words, and perform some listening tests.~      Study participants will undergo magnetic resonance imaging (MRI) to study brain activity. For~     this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine~     with a strong magnetic field. During the MRI scan, the subject will perform simple tasks,~     such as listening to speech or other sounds and saying nonsense words. The procedure should~     take less than 60 minutes, and usually takes from 20 to 40 minutes.~   "
274215|NCT00004732|"~     The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is~     to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the~     traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment~     of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA~     (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in~     those patients who have not had any symptoms within the past 6 months (asymptomatic).~   "
274216|NCT00004731|"~     The purpose of this study is to compare the effects of varying dosage of coenzyme Q10 (CoQ10)~     versus a placebo in the treatment of Parkinson's disease (PD) in patients with early,~     untreated PD.~   "
274277|NCT00004767|"~     OBJECTIVES:~      I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium~     phenylacetate, and dietary intervention in patients with urea cycle disorders.~   "
274199|NCT00004990|"~     This study will test the safety and effectiveness of a monthly dosing regimen of~     dexamethasone-a strong steroid medication-to treat patients with focal segmental~     glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and~     proteinuria (excessive excretion of protein in the urine) that, in about half of the patients~     eventually requires kidney dialysis or transplant. Currently, the most effective treatment~     for FSGS is high-dose steroids (prednisone) taken daily for 4 to 6 months. However, only~     about 30 percent of patients respond to this treatment, and it causes serious side effects in~     many patients. Other drugs, such as cyclosporin and cyclophosphamide, improve proteinuria in~     even fewer patients (about 10 percent) and also have serious side effects. This study will~     explore whether a monthly pulse dose of steroids will achieve disease remission with less~     toxicity.~      Adults and children with FSGS who: 1) have not received steroid treatment, or 2) could not~     tolerate daily steroid treatment, or 3) relapsed after conventional steroid treatment may be~     eligible for this study. Those enrolled will take dexamethasone by mouth for 4 days every 4~     weeks for a total of 8 months. Patients will undergo various tests before treatment starts~     (baseline), during the course of treatment, and in follow-up visits to evaluate the effects~     of treatment as follows:~        1. Review of kidney biopsy, medical evaluation, measurement of total daily urine protein~          excretion and kidney function, psychiatric testing for depression or other mood disorder~        2. Measurements of blood pressure, blood chemistries and urine protein excretion - monthly~          during treatment~        3. Questionnaire about the effects of treatment, if any, on mood and feelings - monthly~          during treatment~        4. Photographs of the face and body (in underwear or shorts and tank top) to evaluate body~          fat distribution- baseline and 8 months~        5. Eye examinations for cataracts and glaucoma - baseline and 8 months~        6. Bone density scan (DEXA scan) of the lower spine and hip - baseline, 4 and 12 months~        7. Magnetic resonance imaging (MRI) of the hips~        8. Psychological evaluation and quality of life evaluation - baseline, 1, 2 and 8 months~        9. Blood tests for adrenal gland function - baseline, 4 and 8 months~       10. Blood and urine tests - 10, 12, 15, and 18 months~      Patients who achieve remission (whose urine protein levels decrease to normal) before~     completing the 8 months of dexamethasone will take one more dose and then stop therapy, but~     continue with follow-up. Patients who achieve remission but relapse may be offered a second~     course of treatment.~   "
274200|NCT00004988|"~     This study will examine the safety and toxicities of intravenously administering a~     genetically modified type of Salmonella bacteria (VNP20009) and its impact on tumor growth in~     advanced or metastatic cancer (cancer that has spread from the primary site). The first~     patients in the study will be given the smallest dose of VNP20009, and those who enter later~     will receive increasingly larger doses. This will be done to determine the maximum dose that~     can be given without serious side effects.~      Normally, Salmonella bacteria ingested in food or water can cause diarrhea or more severe~     illness. The bacteria in this study are altered genetically so they can be injected through a~     vein and circulate in the blood with less likelihood of causing side effects. It is believed~     that the bacteria will travel in the blood to the tumor and infect it. In studies of mice,~     tumor growth slowed in animals whose tumors were infected with VNP0009.~      Patients with advanced or metastatic cancer 18 years of age or older whose disease is not~     responding to standard treatment, or for which there is no treatment, may be eligible for~     this study. Candidates will undergo a medical history and physical examination, including~     blood tests, scans, X-rays, electrocardiogram, and urine, stool and blood cultures.~      Study participants will be admitted to the hospital for 2 to 4 days. On day 1, they will~     receive the first dose of VNP0009, infused over a 30-minute period through an intravenous~     catheter (a small plastic tube inserted into a vein). Blood will be drawn every day to~     determine if the bacteria are still in the body. After discharge, patients will return to the~     hospital on days after approximately 1-2 weeks and again after 4-5 weeks for additional blood~     tests to measure levels of the bacteria and for collection of blood, urine and stool samples.~     Patients whose tumors are on or just beneath the skin may be asked to have one or two tumors~     removed surgically.~      Patients will have tests after approximately 4-5 weeks, including CTs and X-rays, to~     determine the size and extent of the tumor. Patients whose tumor remained the same size or~     smaller than before starting treatment, and whose side effects were acceptable will be~     offered a second treatment cycle. Those whose tumor grew during treatment will be taken off~     the study. Patients remaining in the study will begin the second cycle on approximately day~     36. Tumor growth will be evaluated again between days 64 and 70, and a third cycle will be~     offered to patients whose tumors have remained stable or have shrunk. Patients may have up to~     12 treatment cycles as long as evaluations continue to show the tumor is stable or shrinking.~     Completing all 12 cycles takes about 13 months. Patients will continue to be evaluated after~     treatment ends, if they agree to continued follow-up.~      Patients must follow health precautions to prevent infecting others with Salmonella bacteria~     as long as they, themselves, remain infected. These include, for example, stringent hand~     washing practices and avoiding contact with people with weakened immune systems. All the~     precautions will be explained to the study participants.~      Patients who leave the study must take antibiotic therapy to rid the body of any remaining~     bacteria. They will return for urine, stool and blood cultures 30 days after the start of~     antibiotics, and may undergo three types of scans to look for sites of infection. Treatment~     will be given as needed.~   "
274201|NCT00004984|"~     The Diabetes Prevention Trial of Type 1 (DPT-1) is a multicenter randomized, controlled~     clinical trial designed to determine whether it is possible to delay or prevent the clinical~     onset of type 1 diabetes through daily doses of insulin in individuals determined to be at~     risk for the disease. The parenteral insulin trial in DPT-1 has been completed, however, the~     oral insulin trial is still recruiting. Over 350 sites in the United States, Canada, and~     Puerto Rico are taking part in the study. Screening of patients is ongoing; approximately~     100,000 nondiabetic relatives of persons with type 1 diabetes have been screened to detect~     the presence of islet cell antibodies. Those individuals found to have islet cell antibodies~     are being staged to determine their risk of diabetes based on genetic, immunologic, and~     metabolic characteristics. Those individuals found to be at intermediate risk of diabetes are~     randomized to receive insulin orally or to receive placebo. Patients are being followed for~     up to six years.~   "
274202|NCT00004983|"~     The purpose of this ongoing work in Starr County, located on the Texas-Mexico border, is to~     conduct clinical studies to determine the effectiveness of diabetes self-management programs~     designed specifically for Mexican Americans. The programs meet national standards for~     diabetes self-management education. They are provided in community settings with the primary~     purpose of improving the health of Mexican Americans with diabetes and their family members,~     who either have diabetes or are at risk for developing diabetes.~      The diabetes self-management programs are provided in Spanish and are directed by bilingual~     Hispanic clinical nurse specialists, dietitians, and community health workers. Key elements~     of the programs include instruction on nutrition, self-monitoring of blood glucose, exercise,~     and other diabetes self-management topics, as well as group support to promote behavioral~     changes.~      In the original study (1994-1998), 256 Mexican American adults diagnosed with type 2 diabetes~     and 256 family members or other support persons were enrolled. For one year, the people with~     diabetes, along with their family members, attended small group sessions held in churches,~     community health clinics, adult day care centers, and schools. Information on the~     effectiveness of the program was collected at 3, 6, and 12 months; and annually thereafter.~      Findings of the original study suggested that the program had a positive impact on diabetes~     metabolic control. Levels of diabetes knowledge and rates of glucose self-monitoring and~     attendance suggested that a shorter program - one that incorporated critical elements of the~     previous successful strategy - might result in similar improvements. Thus, the goal of the~     new study, funded in June 1999, was to shorten the original program and to compare it to the~     previous successful program in terms of short- and long-term health outcomes.~      To identify key components of the previous program, we are exploring differences between~     subjects who successfully integrated self-care components of the program and who experienced~     significant improvements in metabolic control and those who were not as successful. The~     program is being revised and shortened, based on this information. Beginning in April 2000,~     we will start recruiting participants for the clinical trial of the revised program.~   "
274203|NCT00004982|"~     Patients with beta-thalassemia (Cooley's Anemia) continue to suffer from the~     transfusion-induced iron overload due to the inadequacies of current iron-chelation therapy.~     Compliance with the use of the only FDA-approved drug for removing excess iron from patients~     (Desferal) continues to be a major problem despite convincing evidence that it markedly~     reduces morbidity and prolongs life. The full potential of iron-chelation therapy will not be~     realized until an orally-effective drug is available. This small trial is testing the premise~     that a combination of drugs as a new approach to iron chelation therapy may reduce side~     effects and increase efficacy. If both drugs can be given orally, there may be a better~     chance of finding a suitable alternative to Desferal. Several combinations of experimental~     iron chelating drugs are being used in this trial.~   "
274204|NCT00004980|"~     OBJECTIVES:~      I. Determine the effect of repetitive transcranial magnetic stimulation on treatment~     refractory auditory hallucinations of patients with schizophrenia.~   "
274205|NCT00004854|"~     We would like to see if using Carvedilol in adjunct with Ace inhibitors will increase~     ejection fraction of the heart under echo. All interpretation of data will be sent to Boston~     Children's Hospital to be reviewed, which is the primary research center in this study. There~     are 5 hospitals participating in this study. The population targeted are children with~     moderate heart failure and must be on Ace inhibitors at the time of enrollment. Our outcome~     after placing them on Carvedilol is to change their ejection fraction on echo. The patients~     will be seen every 1-2 weeks, while we will titrate their medication to a maintenance dose.~     Secondary outcome is to increase quality of life, exercise tolerance and decrease their~     symptom scores as noted on their questionnaires.~   "
274206|NCT00004853|"~     Filgrastim (granulocyte colony-stimulating factor), which is administered by daily~     subcutaneous injection after cytotoxic chemotherapy, shortens the duration of~     chemotherapy-induced neutropenia and lowers the risk of infection. In children treated with~     dose-intensive chemotherapy, filgrastim reduces the duration of severe neutropenia and, as a~     result, has become a standard component of the treatment regimen. Filgrastim-SD/01 (AMGEN),~     which is produced by PEGylation of the amino-terminus of filgrastim, is a sustained duration~     form of granulocyte colony-stimulating factor. In phase I and phase II trials in adults, a~     single dose of Filgrastim-SD/01 appears to be equivalent to daily dosing of filgrastim in~     enhancing neutrophil recovery and has a comparable adverse event profile.~      Dose-intensive vincristine/cyclophosphamide/doxorubicin (VDoxC) alternating with~     ifosfamide/etoposide (IE) has become standard therapy for children and adolescents with~     Ewing's sarcoma and other sarcomas treated at the POB/NCI and other cancer centers within the~     US. Supportive care measures used in children who are treated with this regimen include mesna~     to prevent oxazaphosphorine urotoxicity, dexrazoxane to reduce doxorubicin cardiotoxicity,~     and filgrastim to shorten the duration of neutropenia. The purpose of this randomized open~     label trial is to compare the tolerance, toxicity, and therapeutic effects of~     Filgrastim-SD/01 given as a single injection after chemotherapy to daily subcutaneous~     filgrastim in patients with newly diagnosed sarcoma. The pharmacokinetics of Filgrastim-SD/01~     will also be compared to the pharmacokinetics of filgrastim. This trial will also be a~     platform for performing biological studies of these tumors and for detailed cardiac studies.~     High-risk patients who are treated on this front line trial and respond will also be~     candidates for a planned transplant protocol. A total of 34 patients (17 patients per~     treatment arm) will be entered onto the trial.~   "
274207|NCT00004850|"~     This study will evaluate hepatitis C virus (HCV) infection in blood donors who test positive~     for antibodies to this virus. Most HCV-infected people do not become ill and are not aware~     that they have hepatitis or have had it in the past. Some infected people recover completely,~     whereas others remain chronically infected. The study will try to define infectivity of~     anti-HCV positive individuals, routes of transmission of the virus, and the number of~     HCV-infected persons who have evidence of liver disease.~      Blood donors at the NIH Clinical Center or the Central Maryland Chapter of the American Red~     Cross who test positive for HCV may be eligible for this study. Participants will have a~     physical examination and history, including questions about socioeconomic status and current~     sexual practices. They will have 100 milliliters (ml) (6 tablespoons) of blood drawn at the~     first visit and 50 ml (3 tablespoons) drawn 3, 6, 9 and 12 months after the initial visit.~     Some participants may undergo plasmapheresis, a procedure for collecting additional plasma~     (the liquid portion of the blood). For this procedure, whole blood is collected through a~     needle placed in an arm vein. The blood circulates through a machine that separates it into~     its components. The plasma is then removed, and the red and white cells and platelets are~     returned to the body, either through the same needle used to draw the blood or through a~     second needle placed in the other arm. In some individuals, other body fluids (saliva, urine~     or semen) may also be collected.~      Participants may be asked to bring their household contacts and sexual partners to NIH for~     interview and blood testing for evidence of HCV infection and liver disease. Although this is~     not required for participation in the study, it would provide additional valuable~     information.~      Participants found to have chronic viral infection will be seen more often and will provide~     additional blood samples for routine medical care. Further medical evaluation may include~     X-rays or liver scans and referral to a specialist for additional tests or therapy.~      Ten people in this study will be recruited to participate in a secondary investigation to~     analyze changes in the level of HCV and the immune response to it, and to relate these~     changes to the degree of liver damage. In addition to blood collected for the primary study,~     participants in this investigation will have an additional 50 ml (3 tablespoons) of blood~     drawn from an arm vein every week for 10 weeks to measure levels of virus, ALT (a liver~     enzyme), and immune response.~   "
274208|NCT00004847|"~     The goal of this study is to develop better methods of diagnosis, localization, and treatment~     for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often~     difficult to detect with current methods. Pheochromocytomas release chemicals called~     catecholamines, causing high blood pressure. Undetected, the tumors can lead to severe~     medical consequences, including stroke, heart attack and sudden death, in situations that~     would normally pose little or no risk, such as surgery, general anesthesia or childbirth.~      Patients with pheochromocytoma may be eligible for this study. Candidates will be screened~     with a medical history and physical examination, electrocardiogram, and blood and urine~     tests. Study participants will undergo blood, urine, and imaging tests, described below, to~     detect pheochromocytoma. If a tumor is found, the patient will be offered surgery. If surgery~     is not feasible (for example, if there are multiple tumors that cannot be removed),~     evaluations will continue in follow-up visits. If the tumor cannot be found, the patient will~     be offered medical treatment and efforts to detect the tumor will continue. Main diagnostic~     and research tests may include the following:~        1. Blood tests - mainly measurements of plasma or urine catecholamines and metanephrines as~          well as methoxytyramine. If necessary the clonidine suppression test can be carried out.~        2. Standard imaging tests - Non-investigational imaging tests include computed tomography~          (CT), magnetic resonance imaging (MRI), sonography, and 123I-MIBG scintigraphy and FDG~          (positron emission tomography) PET/CT. These scans may be done before and/or after~          surgical removal of pheochromocytoma.~        3. Research PET scanning is done using an injection of radioactive compounds. Patients may~          undergo 18F-FDOPA, 18F-DA, as well as 68Ga-DOTATATE PET/CT . Each scan takes up to about~          2 hours.~        4. Genetic testing - A small blood sample is collected for DNA analysis and other analyses.~   "
274209|NCT00004846|"~     This study will evaluate the accuracy of an experimental test method called nucleic acid~     amplification technology (NAT) in detecting human immunodeficiency virus (HIV) and hepatitis~     C virus (HCV). This test amplifies the nucleic acid in a virus more than a million-fold,~     allowing early detection of minute quantities of virus in the blood.~      Blood donors to the National Institutes of Health's Department of Transfusion Medicine (blood~     bank) will have their blood screened with transcription mediated amplification, a type of NAT~     test. Donors whose blood is found positive for HIV or HCV by NAT testing will be notified and~     asked to participate in this study. Those who agree will provide a blood sample about once a~     week for 3 months. The samples will be tested with additional assays to detect evidence of~     HIV or HCV infection. If the test results are confirmed positive, no more blood samples will~     be collected. The results of the tests and their significance will be explained to~     participants.~      It is anticipated that NAT screening will reduce the risk of transfusion-related HIV~     transmission from the current 1 in 650,000 to 1 in a million and the risk of HCV transmission~     from the current 1 in 100,000 to 1 in 350,000. It is possible that these tests will~     completely eliminate the risk of transmitting these diseases through blood transfusion.~   "
274210|NCT00004739|"~     The use of protease inhibitors is increasing in HIV-infected children because this treatment~     has resulted in improved body weight, improved immune status and less hospitalizations.~     However, recent reports suggest that these drugs may also be associated with some negative~     side-effects, specifically a syndrome of diabetes and fat redistribution. Development of the~     fat redistribution/diabetes syndrome has recently been reported in HIV-infected children, as~     well as in adults. Diabetes is associated with complications such as increased heart disease,~     eye disease and loss of kidney function. Thus development of diabetes is a significant~     problem which could outweigh the benefits obtained by treating patients with protease~     inhibitors. One major cause of diabetes is lack of normal response to insulin (insulin~     resistance). Insulin resistance tends to be worse in family members where one or more parent~     has diabetes, and is also worse in certain ethnic groups. The first major purpose of our~     study is measure insulin resistance in HIV-infected children who do not take protease~     inhibitors, and compare our findings to those from patients who are treated with protease~     inhibitors. We will also follow patients newly treated with protease inhibitors for two years~     to evaluate changes in insulin sensitivity. These results will be correlated with each~     patient's family history of diabetes and with ethnicity, and should help us better predict~     which children are at risk for development of diabetes from protease inhibitor therapy.~     Children with HIV infection often have problems with gaining enough weight and with poor~     linear growth (height). One likely reason for this is the way their bodies use and store~     protein. The second purpose of our study is measure protein turnover and to correlate our~     findings with growth data. We also plan to study the effects of protease inhibitor therapy on~     protein turnover. We believe that these studies will provide knowledge to help clinicians~     formulate recommendations for nutritional and medical therapy.~   "
274211|NCT00004845|"~     The primary specific aim of this clinical trial is to determine whether treatment with~     rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in~     patients with Alzheimer's disease (AD) as measured by ADAScog.~   "
274212|NCT00004738|"~     The purpose of this study is to better understand the genetic factors related to the Chiari I~     malformation. In people with this abnormality, the lower part of the skull is smaller than~     normal. As a result, the lowest part of the brain, called the cerebellar tonsils, protrudes~     out of the hole at the bottom of the skull into the spinal canal. This study will try to~     discover the location of the genes responsible for the malformation.~      Candidates for this study are: 1) Patients with Chiari I malformation who also have a family~     member with the abnormality or a family member with syringomyelia (a cyst in the spinal cord~     that is often associated with the Chiari I malformation). 2) Family members of patients with~     the Chiari I malformation.~      Participants will have a medical history and physical and neurologic examinations. They will~     undergo magnetic resonance imaging (MRI) of the brain and cervical (neck) spinal cord to~     measure the size of the head and determine the presence of the Chiari I malformation and~     syringomyelia. A small blood sample (about 2 tablespoons) will be drawn for DNA studies~     relating to the Chiari I malformation.~   "
274278|NCT00004763|"~     OBJECTIVES:~      I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and~     leuprolide/oral contraceptive therapy in the management of patients with ovarian~     hyperandrogenism.~   "
274220|NCT00004727|"~     The African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent~     strokes by administration of aspirin or ticlopidine. The study also provides community~     information on reducing risk of stroke and recognizing the symptoms of stroke. The study~     involves more than 50 participating hospitals located throughout the United States. Study~     medication is provided free of charge, and a transportation stipend is available for those in~     need.~   "
274221|NCT00004941|"~     OBJECTIVES:~      I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in~     closure of enterocutaneous fistulae in patients with Crohn's disease.~   "
274222|NCT00004940|"~     OBJECTIVES:~      I. Determine the long-term efficacy and safety of L-cysteine in the prevention~     photosensitivity in patients with erythropoietic protoporphyria.~   "
274223|NCT00004939|"~     OBJECTIVES:~      I. Assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating~     polyneuropathy.~   "
274224|NCT00004938|"~     OBJECTIVE:~      I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral~     sporotrichosis.~   "
274225|NCT00004844|"~     OBJECTIVES:~      I. Assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the~     putamen of patients with Parkinson's disease.~   "
274226|NCT00004843|"~     OBJECTIVES: I. Assess the efficacy of surgery vs no surgery in patients with mild~     asymptomatic primary hyperparathyroidism.~      II. Assess the quality of life, morbidity, and mortality of these patients.~   "
274227|NCT00004842|"~     OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary~     sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to~     ursodeoxycholic acid.~      II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating~     the feasibility of a long-term randomized trial.~   "
274228|NCT00004840|"~     OBJECTIVES:~      I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing~     hormone to women in premature labor to improve pulmonary outcomes in preterm infants.~   "
274229|NCT00004838|"~     OBJECTIVES:~      Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA)~     plus standard treatment to those receiving standard treatment only.~   "
274230|NCT00004834|"~     OBJECTIVES:~      I. Determine which treatment is most effective for patients with panic disorder:~     cognitive-behavioral therapy (CBT) plus imipramine (IMI), CBT plus placebo, CBT alone, IMI~     alone, or placebo alone.~   "
274231|NCT00004833|"~     OBJECTIVES:~      I. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing~     morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome.~      II. Compare the potential risks, in terms of treatment related side effects and adverse~     clinical outcome, between these two treatment modalities.~   "
274232|NCT00004832|"~     OBJECTIVES: I. Evaluate the safety and effectiveness of 3,4-diaminopyridine (DAP) in the~     treatment of patients with Lambert-Eaton myasthenic syndrome (LEMS).~      II. Determine the side-effects and benefits associated with DAP.~   "
274233|NCT00004831|"~     OBJECTIVES:~      I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing~     photosensitivity in patients with erythropoietic protoporphyria.~   "
274234|NCT00004829|"~     OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic~     fibrosis who are chronically colonized with Pseudomonas aeruginosa.~      II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency~     different from the placebo group and whether the emergence of resistance is associated with a~     lack of clinical response.~   "
274235|NCT00004828|"~     OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in~     children undergoing the modified Fontan procedure.~      II. Determine the liothyronine supplementation dose that counters the fall in serum~     liothyronine concentrations and provides the greatest potential myocardial benefit after the~     modified Fontan procedure.~      III. Evaluate the potential toxicity of exogenous liothyronine administered in children~     undergoing a modified Fontan procedure.~   "
274236|NCT00004827|"~     OBJECTIVES:~      I. Evaluate the potential of nutritional docosahexaenoic acid (DHA) supplementation to~     normalize the level of DHA in red blood cells, and to retard the progression of visual~     function loss in patients with early stage X-linked retinitis pigmentosa.~   "
274237|NCT00004826|"~     OBJECTIVES: I. Determine the efficacy and tolerability of clozapine in ameliorating psychosis~     in patients with idiopathic Parkinson's disease (PD).~      II. Determine the adverse effects of clozapine on motor function in this patient population.~      III. Determine the safety of clozapine in psychotic PD patients taking multiple anti-PD~     medications.~      IV. Describe the phenomenology of drug induced psychosis in PD.~   "
274238|NCT00004825|"~     OBJECTIVES: I. Confirm the inhibitory effect of recombinant human insulin-like growth factor~     I (IGF-I) on insulin secretion in children with hyperinsulinism.~      II. Define the effects of short term IGF-I therapy on postprandial blood sugar levels in this~     patient population.~      III. Characterize the effects of short term IGF-I therapy on fasting behavior, and other~     insulin dependent parameters, in this patient population.~   "
274239|NCT00004817|"~     OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will~     reduce the risk of developing seizures as a result of the head injury.~      II. Determine the safety of valproate, the appropriate dose, and the effect valproate may~     have on the recovery of the brain's ability to compute numbers, solve problems, remember~     information, and control the movement of limbs after head injury.~   "
274240|NCT00004816|"~     OBJECTIVES: I. Evaluate the safety and immunogenicity of single and multiple doses of M-T412,~     a chimeric murine-human anti-CD4 monoclonal antibody, in patients with multiple sclerosis.~      II. Evaluate the pharmacokinetics of M-T412. III. Obtain preliminary data on the clinical~     response to M-T412.~   "
274241|NCT00004815|"~     OBJECTIVES:~      I. Assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a~     patient with Werner's syndrome and osteoporosis.~   "
274242|NCT00004814|"~     OBJECTIVES:~      I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic~     polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.~   "
274279|NCT00004762|"~     OBJECTIVES:~      I. Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical,~     radiologic, and histologic parameters in patients with early stage primary sclerosing~     cholangitis.~   "
274243|NCT00004812|"~     OBJECTIVES: I. Assess the ability of patients with and without sensorimotor loss below the~     thoracic spinal cord injury to execute coordinated whole-limb synergies sufficient for~     walking with full or partial weight support.~      II. Promote weight bearing, balance, and reciprocal leg movement in these patients.~      III. Elicit synchronized motor output within and between limbs in these patients.~   "
274244|NCT00004811|"~     OBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and~     sporotrichosis to different doses of itraconazole (R51,211).~      II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course~     of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe~     and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use~     in future comparative trials.~   "
274245|NCT00004810|"~     OBJECTIVES:~      I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to~     moderately severe ulcerative colitis.~   "
274246|NCT00004809|"~     OBJECTIVES:~      I. Develop an approach for treating patients with homozygous familial hypercholesterolemia~     using gene therapy with autologous hepatocytes transduced with a normal low-density~     lipoprotein receptor gene.~   "
274247|NCT00004808|"~     OBJECTIVES: I. Identify a preferred oral fluconazole dose regimen for patients with non-acute~     histoplasmosis or blastomycosis, or ulcerocutaneous or deep sporotrichosis.~      II. Study the safety and efficacy of fluconazole in these patients.~   "
274248|NCT00004807|"~     OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome~     (RS).~      II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of~     cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine,~     while continuing supportive care to modify seizures, respiratory abnormalities, and motor~     disturbances, and improve nutrition, behavior, and learning.~      IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence~     neurologic recovery.~   "
274249|NCT00004806|"~     OBJECTIVES:~      Evaluate the efficacy and safety of lipid-mediated transfer of the cystic fibrosis~     transmembrane conductance regulator gene to nasal epithelium in patients with cystic~     fibrosis.~   "
274250|NCT00004805|"~     OBJECTIVES: I. Describe the psychosocial response of parents and caretakers who learn~     cardiopulmonary resuscitation (CPR) techniques for infants at high risk for respiratory or~     cardiac arrest.~      II. Compare the effect of 4 methods of CPR instruction on psychosocial response.~      III. Evaluate a psychological intervention based on social support theory designed to offset~     the potential adverse psychological outcomes of CPR instruction.~      IV. Evaluate a self-paced CPR learning module using the principles of adult learning theory.~      V. Document the level of CPR knowledge and skill retention over time. VI. Document the~     frequency of CPR and its outcome following a witnessed respiratory or cardiac arrest.~   "
274251|NCT00004804|"~     OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be~     increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis~     C.~      II. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can~     maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.~   "
274252|NCT00004802|"~     OBJECTIVES:~      I. Assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in~     patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodic~     paralysis, and hypokalemic periodic paralysis.~   "
274253|NCT00004801|"~     OBJECTIVES:~      Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with~     factor IX deficiency.~   "
274254|NCT00004800|"~     OBJECTIVES: I. Compare the efficacy of 2 acellular pertussis vaccines vs. whole-cell~     pertussis vaccine vs. placebo in infants living in Italy.~      II. Compare the relative protection of each of the acellular vaccines vs. the whole-cell~     vaccine vs. laboratory-confirmed pertussis.~      III. Assess the relative efficacy of the acellular vaccines with respect to one another.~      IV. Assess the immunogenicity of acellular vs. whole-cell vaccines in the study population.~      V. Compare the frequency of adverse events with each vaccine. VI. Compare the frequency of~     adverse events attributable to the pertussis component in each of the 3 vaccines.~      VII. Assess alternative laboratory diagnostic techniques for pertussis in estimating vaccine~     efficacy, i.e., mucosal immune response, DNA probes, or antibody response to other components~     of the organism.~      VIII. Assess the relative efficacy estimates of each vaccine, using clinical criteria to~     compare the relative incidence rates in each vaccine group.~   "
274255|NCT00004799|"~     OBJECTIVES: I. Compare the safety and efficacy of acellular 2-component vs. acellular~     multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in Sweden.~      II. Compare the relative protection of each vaccine against atypical or subclinical pertussis~     infection.~      III. Analyze possible laboratory correlates to vaccine protection.~   "
274256|NCT00004797|"~     OBJECTIVES: I. Evaluate the efficacy and tolerability of fructose administered every 6 hours~     for up to 72 hours to patients in active sickle cell crisis.~      II. Obtain tolerability information in selected patients treated with fructose for more than~     72 hours.~   "
274257|NCT00004796|"~     OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in~     patients with subclinical hepatic encephalopathy.~      II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological~     tests.~      III. Assess which elements of the neuropsychological test battery show the response to~     lactulose.~   "
274258|NCT00004795|"~     OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone (GL701)~     in women with prednisone-dependent systemic lupus erythematosus.~      II. Describe the pharmacokinetics of GL701.~   "
274259|NCT00004794|"~     OBJECTIVES: I. Evaluate the safety and efficacy of intravenous cidofovir in patients with~     small peripheral cytomegalovirus retinitis.~      II. Obtain safety and efficacy data related to different dosages of cidofovir.~   "
274260|NCT00004793|"~     OBJECTIVES: I. Evaluate the effect of bromocriptine on luteinizing hormone (LH) secretion by~     suppression of prolactin and stimulation of dopaminergic receptors in early pubertal boys and~     girls.~      II. Evaluate the effect of baclofen on LH secretion by stimulation of gamma-aminobutyric acid~     receptors in early pubertal boys and girls.~   "
274297|NCT00004697|"~     OBJECTIVES:~      I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis~     and improve liver function in patients who receive long term total parenteral nutrition.~   "
274261|NCT00004791|"~     OBJECTIVES: I. Characterize the nutritional and metabolic profile of children and adolescents~     with epidermolysis bullosa.~      II. Determine patterns of body composition in these patients. III. Determine the energy~     requirements of these patients by measuring resting energy expenditure.~      IV. Assess protein nutrition by measuring lean body mass.~   "
274262|NCT00004789|"~     OBJECTIVES: I. Evaluate the efficacy and safety of heme arginate in the treatment of 20~     patients with acute attacks of porphyria.~      II. Evaluate the efficacy and safety of heme arginate in preventing frequent exacerbations of~     acute porphyria in up to 15 patients.~      III. Estimate the lowest effective dose of heme arginate (0.3, 1.0, or 3.0 mg/kg) in reducing~     porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.~      IV. Evaluate the safety and efficacy of tin mesoporphyrin used in combination with heme~     arginate in reducing porphyrin precursors in 12 stable patients with acute intermittent~     porphyria in remission.~   "
274263|NCT00004788|"~     OBJECTIVES: I. Determine whether differences in dietary habits are associated with disease~     activity in patients with acute intermittent porphyria.~      II. Determine whether premenstrual porphyria attacks are associated with increased luteal~     phase energy requirements.~      III. Determine whether energy requirements are higher than intakes in men with unexplained~     frequent porphyria attacks.~      IV. Assess the nutritional status of women with acute intermittent porphyria using a~     comprehensive series of laboratory methods, including zinc and pyridoxine status.~      V. Determine whether the frequency of disease exacerbations decreases when dietary and~     nutritional abnormalities are corrected in these patients.~      VI. Evaluate the safety and efficacy of a parenteral nutrition regimen for patients with~     acute porphyria attacks.~   "
274264|NCT00004787|"~     OBJECTIVES: I. Assess the efficacy of recombinant human granulocyte colony-stimulating factor~     (G-CSF) in raising the absolute neutrophil count, platelet count, and hemoglobin level in~     patients with inherited bone marrow failure syndromes.~      II. Assess the efficacy of a reduced maintenance dose in patients who respond to daily G-CSF.~      III. Assess the toxic effects of G-CSF in these patients. IV. Measure bone marrow progenitor~     colonies before and after G-CSF. V. Measure CD34-positive cells in marrow and blood before~     and after G-CSF using flow cytometry and immunohistochemistry.~   "
274265|NCT00004786|"~     OBJECTIVES:~      I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with~     Raynaud's phenomenon secondary to systemic sclerosis.~   "
274266|NCT00004785|"~     OBJECTIVES: I. Compare the efficacy of dexamethasone (DM) vs. DM/methylprednisolone treatment~     vs. placebo, initiated within the first month of life, on long-term pulmonary and~     developmental outcomes in premature infants with evolving bronchopulmonary dysplasia.~      II. Compare the toxicities of these treatments. III. Assess treatment effects on adrenal~     function.~   "
274267|NCT00004784|"~     OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without~     methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity~     in patients with primary biliary cirrhosis.~      II. Compare the effects of these regimens on the development of ascites, encephalopathy,~     varices (or bleeding from pre-existing varices), histologic liver changes, transplantation,~     and survival.~      III. Compare the toxicity and safety of each regimen.~   "
274268|NCT00004781|"~     OBJECTIVES: I. Evaluate the development of oral manifestations of human immunodeficiency~     virus infection in relationship to the onset of immunologic alterations and systemic symptoms~     in different risk groups: gay/bisexual men, male intravenous drug users, and female~     intravenous drug users.~      II. Evaluate the immune and inflammatory response to periodontal and other microbial~     pathogens.~      III. Evaluate the bacterial species infecting the oral cavity in patients in these risk~     groups.~   "
274269|NCT00004779|"~     OBJECTIVES: I. Assess the safety and efficacy of gene transfer into the nasal epithelium~     using Ad5-CB-CFTR, an E1-deleted adenovirus vector containing the cystic fibrosis~     transmembrane conductance regulator gene, in patients with cystic fibrosis (CF).~      II. Determine whether ion transport abnormalities in CF airway cells can be corrected.~   "
274270|NCT00004778|"~     OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of~     initial lung disease and occurrence of chronic lung disease when given antenatally to women~     with threatened premature delivery.~      II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of~     chronic lung disease.~      III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after~     birth influences the severity of lung disease and the development of chronic lung disease.~   "
274271|NCT00004776|"~     OBJECTIVES:~      I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut~     syndrome.~   "
274272|NCT00004773|"~     OBJECTIVES: I. Evaluate electrocardiographic parameters, including QT and PR intervals and~     QRS morphology/duration, across clinical stages in patients with Rett syndrome.~      II. Characterize abnormalities of cardiac conduction and repolarization. III. Assess~     arrhythmias, heart rate variability, and autonomic nervous system function in these patients~     using 24-hour Holter monitoring.~      IV. Record events believed to represent seizures with video, electroencephalogram (EEG), and~     polygraph monitoring in patients who have more than 1 clinical seizure every 5 days.~      V. Characterize these events with respect to clinical manifestations, EEG correlates, and~     other physiologic data.~      VI. Determine the frequency of seizures vs. events without electrographic correlates in these~     patients.~      VII. Determine whether Rett syndrome patients have characteristic or unique types of seizures~     and/or an epileptic syndrome.~   "
274273|NCT00004772|"~     OBJECTIVES:~      I. Compare the response of previously untreated patients with chronic inflammatory~     demyelinating polyneuropathy to intravenous immune globulin vs. placebo.~   "
274274|NCT00004771|"~     OBJECTIVES:~      I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with~     testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron~     disease.~   "
274275|NCT00004770|"~     OBJECTIVES:~      I. Assess the efficacy of thioctic acid in treating a single patient with mitochondrial~     myopathy.~   "
274276|NCT00004769|"~     OBJECTIVES: I. Examine the interrelationships between muscle wasting (phenotype), the degree~     of myotonic dystrophy (DM) gene expression (genotype) in patients with DM.~      II. Characterize the insulin resistance in these patients. III. Assess the glucose uptake in~     the leg and forearm tissues of these patients.~      IV. Determine the stability of the DM gene lesion in muscles over a 5-10 year period.~   "
274280|NCT00004761|"~     OBJECTIVES: I. Develop a large roster of well-characterized patients with various forms of~     inherited and acquired epidermolysis bullosa (EB).~      II. Generate a large data bank of clinical, historical, and genetic information concerning~     these patients.~      III. Accumulate donated tissue specimens, including selected cells and DNA, from selected~     patient subsets for the establishment of permanent tissue cell banks.~      IV. Promote and facilitate research in EB.~   "
274281|NCT00004760|"~     OBJECTIVES:~      I. Compare the benefit of exercise versus usual care (no exercise) on impairments and~     functional limitations in patients with Parkinson disease.~   "
274282|NCT00004759|"~     OBJECTIVES:~      I. Compare the efficacy and safety of 24- versus 48-hour infusion of methylprednisolone~     (MePRDL) versus tirilazad for patients with acute spinal cord injury.~      II. Compare neurologic recovery following 24- and 48-hour MePRDL infusions.~   "
274283|NCT00004758|"~     OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of~     cortical abnormality versus multiple drug therapy in children with infantile spasms~     refractory to standard therapy.~      II. Assess how infantile spasms interfere with development and whether this is partially~     reversible.~      III. Determine the predictors of good surgical outcome and whether surgery permanently~     controls seizures and improves development.~   "
274284|NCT00004757|"~     OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin~     lesions and improves neurologic outcome in neonates with localized herpes simplex virus type~     2 infection when administered for 6 months in a placebo-controlled study.~      II. Determine whether the prevention of recurrent skin lesions reduces long-term neurologic~     morbidity.~      III. Determine whether resistant disease develops after oral ACV therapy. IV. Evaluate the~     natural history of recurrent skin lesions. V. Measure any adverse effects and laboratory~     abnormalities associated with long-term oral ACV therapy in infants and young children.~   "
274285|NCT00004756|"~     OBJECTIVES:~      I. Evaluate an educational program that has been pretested for cultural appropriateness and~     literacy requirements in patients with systemic lupus erythematosus (SLE).~      II. Assess the impact of this educational program on patients with SLE, with an emphasis on~     recognizing cardinal symptoms, coping with fatigue, regulating medications, and communicating~     with the physician.~   "
274286|NCT00004755|"~     OBJECTIVE:~      Compare the efficacy and side effects of allopurinol versus glucantime versus~     allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.~   "
274287|NCT00004754|"~     OBJECTIVES: I. Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion to~     patients with severe primary pulmonary hypertension for whom no alternative therapy is~     available.~      II. Obtain additional safety information on continuous infusion epoprostenol. III. Obtain~     additional information on economic resource health consumption.~   "
274288|NCT00004753|"~     OBJECTIVES: I. Correlate clinical outcome with cerebral glucose metabolism in patients with~     Huntington's disease (HD) and their at-risk relatives.~      II. Evaluate the efficacy of cerebral glucose metabolism in observing the pathophysiologic~     development of HD, monitoring responses to experimental therapy, and predicting HD genotype.~      III. Identify, define, and describe the natural history of pathophysiologic lesions in HD.~      IV. Characterize the genotypic and phenotypic expression of the HD gene.~   "
274289|NCT00004751|"~     OBJECTIVES:~      I. Assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared~     with physiotherapy alone in improving gross motor function and reducing spasticity in~     children with spastic diplegia.~   "
274290|NCT00004748|"~     OBJECTIVES:~      I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus~     colchicine and ursodiol in patients with primary biliary cirrhosis (PBC).~      II. Determine the optimum dose and duration of MTX treatment.~      III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of~     treatment on FC production.~   "
274291|NCT00004747|"~     OBJECTIVES: I. Assess the efficacy of monthly intravenous mucoid exopolysaccharide~     Pseudomonas aeruginosa immune globulin (MEP IGIV) given over 1 year in reducing the frequency~     of acute pulmonary exacerbation in patients with cystic fibrosis, mild to moderate pulmonary~     disease, and mucoid P. aeruginosa colonization.~      II. Assess the effect of MEP IGIV on FEV1, sputum density of mucoid P. aeruginosa, and the~     quality of life in these patients.~      III. Assess the safety of monthly MEP IGIV. IV. Assess population-based MEP IGIV~     pharmacokinetics during chronic therapy.~   "
274292|NCT00004744|"~     OBJECTIVES: I. Determine whether high-dose intravenous immune globulin (IVIG) is more~     effective than placebo in restoring neurologic function (muscle strength) in patients with~     multiple sclerosis.~      II. Determine the time to recovery following IVIG.~   "
274293|NCT00004740|"~     OBJECTIVES: I. Recruit 300 injection drug users with positive tuberculin skin tests who are~     candidates for isoniazid chemoprophylaxis into a trial of several interventions to enhance~     adherence to preventive therapy.~      II. Compare the effectiveness of self-administered isoniazid chemoprophylaxis supplemented~     with peer education and support groups versus directly observed preventive therapy delivered~     by a licensed nurse versus self-administered therapy with standard clinic follow-up and~     education. Outcome measures are adherence to prescribed doses of medication and the~     proportion of patients who complete therapy.~      III. Compare the impact of monetary incentives on therapy adherence by random assignment to~     immediate vs. deferred financial incentive.~      IV. Assess attitudes, knowledge, and beliefs about tuberculosis and preventive therapy in~     these patients and determine the association of these factors with demographic, social, and~     clinical characteristics.~      V. Assess attitudes and beliefs about tuberculosis susceptibility, seriousness, benefits of~     preventive therapy, barriers to therapy, and self-efficacy as predictors of health-related~     behaviors as measured by adherence with therapy, and determine the impact of the assigned~     interventions on these attitudes and beliefs.~   "
274294|NCT00004705|"~     OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the~     metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic~     fibrosis.~      II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic~     fibrosis.~   "
274295|NCT00004700|"~     OBJECTIVES:~      Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I~     in children with hyperinsulinism.~   "
274296|NCT00004699|"~     OBJECTIVES:~      I. Determine the dose of recombinant human insulin-like growth factor I that minimizes or~     decreases the need for exogenous glucose support without causing hypoglycemia.~   "
274298|NCT00004696|"~     OBJECTIVES: I. Compare nonmechanically ventilated infants who receive morphine~     postoperatively as intermittent intravenous bolus doses or as a continuous intravenous~     infusion targeted to reach a steady-state concentration.~      II. Assess ventilation (blood gases, continuous oximetry, and CO2 response curves) and~     analgesia (infant pain score) between the two treatment groups of infants.~      III. Compare ventilation parameters (blood gases, CO2 response curves, and time to wean from~     assisted mechanical ventilation) in cyanotic and acyanotic infants after thoracotomies.~   "
274299|NCT00004695|"~     OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can~     reduce the number of infections in patients with common variable immunodeficiency.~      II. Determine whether this therapy can improve lung functions in these patients with~     pulmonary impairment.~   "
274300|NCT00004694|"~     OBJECTIVES:~      I. Determine the safety and efficacy of inhaled and subcutaneously administered heparin in~     the treatment of hereditary angioedema.~   "
274301|NCT00004690|"~     OBJECTIVES: I. Compare the safety and efficacy of monolaurin cream versus a placebo vehicle~     cream in suppressing the signs of nonbullous congenital ichthyosiform erythroderma.~      II. Assess the incidence of posttreatment rebound or recrudescence in patients with~     congenital ichthyosis.~      III. Evaluate the long term safety of monolaurin cream with whole body application in these~     patients.~   "
274302|NCT00004689|"~     OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium~     avium complex (MAC) pulmonary disease.~      II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC~     infection.~      III. Determine the safety and tolerance of amithiozone with chronic dosing in these patients.~      IV. Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin,~     and amithiozone in the treatment of pulmonary MAC infection.~   "
274303|NCT00004688|"~     OBJECTIVES:~      I. Assess the clinical response of patients with refractory or recurrent brain neoplasms~     treated with carmustine, streptozocin, and mercaptopurine.~   "
274304|NCT00004686|"~     OBJECTIVES: I. Compare the long term outcomes in patients with giant cell arteritis after~     glucocorticoid treatment with or without methotrexate.~      II. Compare remission relapse rates in these patients after glucocorticoid therapy with or~     without methotrexate.~      III. Determine whether adjunctive use of methotrexate lowers cumulative dose and duration of~     glucocorticoid therapy and whether there is less treatment related morbidity and mortality.~      IV. Demonstrate the feasibility of long term, double blind, placebo controlled, randomized,~     multicenter trials for treatment of systemic vasculitides.~   "
274305|NCT00004685|"~     OBJECTIVES: I. Determine whether albuterol increases strength in patients with~     facioscapulohumeral dystrophy as measured by quantitative voluntary isometric contraction~     testing.~      II. Determine whether albuterol increases muscle mass in this patient population as~     determined by 24 hour urinary creatinine excretion and dual energy x-ray absorptiometry~     (DEXA).~      III. Examine the long term safety of albuterol in this patient population.~   "
274306|NCT00004682|"~     OBJECTIVES:~      I. Determine whether intravenous immunoglobulin is an effective therapy for patients with~     mild or moderate myasthenia gravis.~   "
274307|NCT00004670|"~     OBJECTIVES:~      I. Evaluate the safety and efficacy of pallidotomy immediately following 3 preoperative~     assessments vs. delayed pallidotomy following 6 months of standard medical therapy in~     patients with Parkinson disease.~   "
274308|NCT00004669|"~     OBJECTIVES: I. Estimate the efficacy of cortisol replacement therapy during the first 12 days~     of life for prevention of bronchopulmonary dysplasia.~      II. Estimate the effect of cortisol replacement therapy on the signs of acute adrenal~     insufficiency.~      III. Evaluate the effects of cortisol replacement therapy on adrenal hormone concentrations~     and on the ability of the adrenal gland to respond to ACTH.~      IV. Determine the effect of this replacement therapy on markers of inflammation in lung~     lavage fluid and peripheral blood leukocytes.~   "
274309|NCT00004667|"~     OBJECTIVES: I. Evaluate the effect of a new von Willebrand factor concentrate on bleeding~     time, in vivo recovery, and circulating half-life of the infused factor in patients with von~     Willebrand's disease.~      II. Assess the safety of von Willebrand factor in these patients.~   "
274310|NCT00004665|"~     OBJECTIVES:~      I. Evaluate the long-term safety and tolerance of a synthetic formulation of~     dehydroepiandrosterone, GL701, in patients with systemic lupus erythematosus who have~     completed a prior GL701 protocol.~   "
274311|NCT00004664|"~     OBJECTIVES: I. Evaluate the effect of aerobic exercise and progressive resistance plus~     megestrol acetate on lean body mass of patients with human immunodeficiency virus-related~     weight loss (HIV-wasting).~      II. Evaluate whether exercise acutely alters immune function. III. Evaluate whether long-term~     exercise improves immunocompetence. IV. Evaluate the accuracy of multifrequency bioelectrical~     impedance spectral analysis in measuring body composition.~      V. Assess the impact of these therapies on quality of life. VI. Evaluate the effect of these~     therapies on the balance of energy intake and energy expenditure.~   "
274312|NCT00004663|"~     OBJECTIVES: I. Evaluate whether pregnancy is an independent risk factor that affects disease~     activity in women with systemic lupus erythematosus.~      II. Evaluate whether maternal disease activity is a risk factor for adverse pregnancy~     outcome.~   "
274313|NCT00004662|"~     OBJECTIVES:~      I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with~     active systemic lupus erythematosus.~   "
274314|NCT00004661|"~     OBJECTIVES:~      Determine the relationship between serum calcium concentrations and parathyroid hormone~     secretion in patients with pseudohypoparathyroidism.~   "
274315|NCT00004660|"~     OBJECTIVES: I. Evaluate the effects of 20 Gy of external-beam radiotherapy to 1 orbit vs. the~     untreated orbit at 3 and 6 months after therapy in patients with Graves' ophthalmopathy.~      II. Evaluate whether 20 Gy of external-beam radiotherapy delivered to the second orbit 6~     months later in the course of the disease produces effects of equal magnitude to those~     observed when the first orbit was treated.~      III. Relate the magnitude of treatment effects to the time since onset of eye symptoms.~      IV. Evaluate whether characteristics of radiation retinopathy are present 3 years after~     orbital radiotherapy.~   "
274316|NCT00004659|"~     OBJECTIVES: I. Evaluate whether stereotactic radiosurgery provides local control at multiple~     sites in patients with primary or metastatic brain tumors, controlled systemic disease, and~     preserved neurologic function.~      II. Examine survival, clinical outcome, and local tumor imaging response in these patients.~   "
274318|NCT00004656|"~     OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in~     healthy controls.~      II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining,~     sitting, and standing, by whole-room indirect calorimetry and isotope dilution.~      III. Quantify activity patterns by time-motion studies using 24-hour activity records and~     12-hour videotaping.~      IV. Correlate 24-hour activity patterns with 24-hour heart rate telemetry and short-term~     oxygen consumption.~      V. Estimate 24-hour fecal and urinary energy losses. VI. Determine body composition by~     clinical anthropometry, whole-body potassium counting, and total-body electrical conductance.~      VII. Calculate apparent energy needs based on measurement of energy intake and expenditure.~   "
274319|NCT00004654|"~     OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with~     hereditary hemorrhagic telangiectasia.~      II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and~     gastrointestinal bleeding in these patients.~   "
274320|NCT00004652|"~     OBJECTIVES: I. Determine whether the time period between randomization and endpoint is longer~     in the short term pimozide therapy or longer term therapy in patients with Tourette syndrome.~      II. Determine whether tic severity, medication side effects, academic performance and~     psychosocial functioning are better in the short term pimozide therapy or longer term~     pimozide therapy.~   "
274321|NCT00004650|"~     OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women.~      II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients.~      III. Determine whether changes in periodontal bone mass relate to bone mass changes in other~     skeletal sites in these patients.~   "
274322|NCT00004649|"~     OBJECTIVES: I. Collect data regarding the natural history of hereditary hemorrhagic~     telangiectasia (HHT).~      II. Establish genotype-phenotype correlations in HHT. III. Create a database of information~     for researchers throughout the world.~   "
274323|NCT00004648|"~     OBJECTIVES: I. Examine screening modalities for pulmonary vascular arteriovenous malformation~     (PAVM) in individuals with endoglin mutations.~      II. Examine the prevalence of cerebral arteriovenous malformations (CAVM) in individuals with~     hereditary hemorrhagic telangiectasia (HHT).~      III. Investigate whether modifier genes exist that determine which individuals with HHT due~     to an endoglin mutation develop PAVMs and which develop CAVMs.~      IV. Investigate the frequency of cardiac valve abnormalities in individuals affected with HHT~     due to an endoglin mutations.~   "
274324|NCT00004647|"~     OBJECTIVES:~      I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain~     in patients with diabetic neuropathy.~   "
274325|NCT00004646|"~     OBJECTIVES: I. Characterize the effect of prednisone on muscle protein metabolism in patients~     with Duchenne muscular dystrophy.~      II. Determine whether prednisone changes levels of insulin-like growth factor 1, growth~     hormone, and insulin.~      III. Characterize the effect of prednisone on muscle morphometry and muscle localization of~     utrophin.~      IV. Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen~     in normal individuals and in patients with facioscapulohumeral dystrophy.~   "
274326|NCT00004645|"~     OBJECTIVES:~      I. Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of~     inflammatory demyelinating disease in patients who have failed intravenous steroid therapy.~   "
274327|NCT00004644|"~     OBJECTIVES: I. Evaluate whether high-dose acyclovir decreases acute and long-term morbidity~     and mortality in neonates with central nervous system or disseminated herpes simplex virus~     (HSV) infection.~      II. Evaluate whether high-dose acyclovir is safe and tolerated in the newborn. III. Assess~     resistance to antiviral medication. IV. Amplify disease classification for the purpose of~     predicting prognosis. V. Assess any changes in viral excretion patterns. VI. Evaluate whether~     antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid (CSF)~     predict long-term neurologic outcome.~      VII. Evaluate whether specific antigens and antibodies in the CSF appear late after treatment~     and are indicative of insidious reactivation of virus in the brain.~   "
274328|NCT00004643|"~     OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus~     erythematosus.~      II. Evaluate objective disease parameters, including serum complement levels, anti-DNA~     antibody titers, sedimentation rate, and the systemic lupus activity measure in these~     patients.~   "
274329|NCT00004642|"~     OBJECTIVES: I. Evaluate the safety, tolerance, and potential efficacy of 3 doses of human~     anti-cytomegalovirus (CMV) monoclonal antibody SDZ MSL-109 (MOAB MSL-109) in the treatment of~     newborns with congenital CMV infection and no central nervous system disease.~      II. Determine the relationship between plasma concentrations of MOAB MSL-109 and therapeutic~     outcome.~      III. Determine whether MOAB MSL-109 influences the antibody response and clearance of virus~     from the urine.~   "
274330|NCT00004638|"~     Chronic sinusitis is a common pediatric disease; it ranks among the top five infectious~     diseases of the upper respiratory tract. Its treatment is limited and may be due largely in~     part to a lack of understanding of its cause. The investigators have preliminary data to~     support the notion that pediatric chronic sinusitis is a distinct disease, different from~     acute sinusitis and adult chronic sinusitis. We are proposing to perform pathogenesis studies~     in children with chronic sinusitis. Specifically, we wish to elucidate the microbiologic~     features and immunologic factors involved in the formation of this disease. The study plan~     calls for microbiologic (bacterial, viral, and fungal) and immunologic (inflammatory~     mediators and leukocyte populations) data to be evaluated through a maxillary sinus washing~     and mucosal biopsies. Four populations will be studied and they are: 10 children with chronic~     sinusitis, 5 children with acute sinusitis (positive control), 5 children without sinusitis~     (negative control) and 5 adults with chronic sinusitis (positive secondary control).~   "
274351|NCT00004554|"~     This study will examine depressed alcoholic outpatients to assess whether combining~     naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking~     and depression over either medication alone or placebo. A secondary aim is to determine~     whether certain patient features will predict response to sertraline, naltrexone or the~     combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks.~     The followup phase includes two visits at 6 and 9 months after treatment.~   "
275023|NCT00000520|"~     To test the efficacy of intravenous gamma globulin (IVGG) in preventing coronary artery~     aneurysms in children with Kawasaki Syndrome.~   "
274331|NCT00004637|"~     This is a study to see if vitamin E helps children with epilepsy have fewer seizures. About~     20-30% of children with epilepsy do not have adequate seizure control with established~     antiepileptic drugs (AEDs). Other options for patients with uncontrolled epilepsy are newer~     antiepileptic medications, ketogenic diet and surgery. However, a small percentage of~     patients are candidates for these options. Therefore, additional treatments are needed to~     improve seizure control in patients with uncontrolled epilepsy. Animal studies have shown an~     association between vitamin E supplementation and seizure reduction. A study in children also~     showed that vitamin E helped reduce seizures. However, a similar study in adults did not show~     a reduction in seizures with vitamin E supplementation. Therefore, this research study is~     being done to help define vitamin E's usefulness and safety as a treatment for epilepsy.~     Fifty patients will be recruited from the Children's Epilepsy Program at The Children's~     Hospital in Denver, Colorado. Qualifying patients will have a confirmed diagnosis of epilepsy~     that is currently uncontrolled with standard AEDs. The study period is 6 months and includes~     the following: Baseline period (1 month), Arm I (2 months), Wash-out period (1 month), and~     Arm II (2 months). Patients must have been on the same AEDs for 2 months before enrollment.~     All medications and complementary therapies must remain constant throughout the study. If at~     any point the physician feels it is not best for the patient to continue the study they will~     be discontinued. Before the study starts, study participants will be asked about seizure~     activity, what they eat and about any complementary and/or alternative medicine they may use.~     The study is two phases. Study participants will be given either vitamin E or placebo (fake~     pill/liquid) in each phase of the study. They will receive both vitamin E and placebo during~     the study. Which phase they receive vitamin E and placebo will be decided by chance (similar~     to rolling dice). Study participants will take liquid vitamin E or placebo two times per day.~     The study participants and study doctors will not know who is taking vitamin E and who is~     taking placebo. Study participants will come to the hospital for 3 outpatient and 2 inpatient~     visits. Health-related quality of life questionnaires will be filled out and blood will be~     drawn at three of the visits. Seizure diaries will be maintained throughout the study.~   "
274332|NCT00004635|"~     This multi-center study will evaluate whether thalidomide can improve the effectiveness of~     the drugs leuprolide or goserelin in treating testosterone-dependent prostate cancer.~     Leuprolide and goserelin-both approved to treat prostate cancer-reduce testosterone~     production, which, in most patients, reduces the size of the tumor. Thalidomide, a drug used~     for many years to treat leprosy, blocks the growth of blood vessels that may be important to~     disease progression.~      Patients 18 years or older with testosterone-dependent prostate cancer that has persisted or~     recurred after having had surgery, radiation therapy, or cryosurgery, but whose disease has~     not metastasized (spread beyond the prostate) may be eligible for this study. Candidates are~     screened with a medical history and physical examination, including blood tests, bone and~     computed tomography (CT) scans or other imaging studies.~      Study participants are randomly assigned to one of two treatment groups. One group receives~     leuprolide or goserelin followed by thalidomide; the other receives leuprolide or goserelin~     followed by placebo (a look-alike pill with no active ingredients). Patients in both groups~     receive an injection of leuprolide or goserelin once a month for 6 months. After that time~     they take four capsules of either thalidomide or placebo once a day and remain on the drug~     until their prostate-specific antigen (PSA) level returns to what it was before beginning~     leuprolide or goserelin or to 5 nanograms per liter, whichever is lower.(PSA is a protein~     secreted by the prostate gland. Monitoring changes in levels of this protein can help~     evaluate tumor progression). At this point the entire procedure begins again, starting with~     leuprolide or goserelin treatment, but the experimental drug is switched; patients originally~     treated with thalidomide are crossed over to placebo, and patients originally treated with~     placebo are crossed over to thalidomide.~      Patients are monitored periodically with the following tests and procedures:~      Medical histories and physical examinations. Blood and urine tests to monitor thalidomide and~     PSA levels, the response to treatment, and routine laboratory values (e.g., cell counts and~     kidney and liver function).~      Computed tomography (CT) and bone scans, and possibly other imaging tests to assess the~     tumor.~      Electromyography (EMG) and nerve conduction studies, as needed. For electromyography, a thin~     needle is inserted into a few muscles and the patient is asked to relax or to contract the~     muscles.~   "
274333|NCT00004577|"~     The purpose of this investigation is to develop improved magnetic resonance imaging (MRI)~     techniques and hardware for studying brain function. MRI is a diagnostic tool that provides~     information about brain chemistry and physiology. This study will evaluate new MRI methods~     for monitoring blood flow to regions of the brain in response to simple tasks. The MRI~     machine used in this study is more powerful than those in most hospitals, permitting a higher~     visual resolution.~      Normal healthy volunteers over 18 years old may be eligible for this study. Candidates will~     be screened with a medical history and questionnaire, and a neurological examination. Study~     participants will have a yearly MRI scan. For this procedure, the subject lies on a stretcher~     that is moved into a donut-shaped machine with a strong magnetic field. A lightweight~     circular or rectangular coil a device that improves the quality of the images may be placed~     on the head. The scan time varies from 20 minutes to 3 hours; most scans last between 45 and~     90 minutes. During the scan, the subject may perform simple tasks, such as listening to~     tapes, tapping a finger, moving a hand, watching a screen, or smelling a fragrance. More~     complex tasks may require thinking about tones or pictures and responding to them by pressing~     buttons.~      Information from this study will be used to develop better imaging methods that will, in~     turn, permit a greater understanding of normal and abnormal brain behaviors.~   "
274334|NCT00004573|"~     The overall purpose of this research is to develop and use a blood test to better understand~     how quickly the viral drug ganciclovir works to clear infection with the CMV virus~     (Cytomegalovirus) when it occurs. This test will potentially let doctors know early in the~     course of therapy when a virus is not responding well to the therapy and could therefore be~     resistant to the drug. The target population of this study will be primarily kidney and lung~     transplant patients with CMV detected in the blood, although other patients may also be~     included if they meet criteria. The study will be divided into two phases. Phase I will~     evaluate a small number of exploratory patients initiating ganciclovir therapy and will~     require frequent blood sampling to obtain detailed information regarding the kinetic response~     of the virus to therapy. This information will be analyzed to help guide decisions regarding~     the number and frequency of blood samples needed in the larger phase II portion of the study.~     Strains will be characterized using phenotypic and genotypic methods to determine the~     presence or absence of mutations potentially responsible for the resistance.~   "
274335|NCT00004572|"~     The two major types of diabetes are type 1 and type 2 diabetes. Although most patients with~     type 2 diabetes are older than age 40, type 2 diabetes has been reported with increasing~     frequency among patients under the age of 20. This form of diabetes has been called type 2~     diabetes of youth, abbreviated type 2Y. Little is known about the etiology of type 2Y;~     however, clinicians believe that it occurs most commonly in obese children of particular~     ethnic groups. A positive family history appears to be one major risk factor for developing~     type 2Y diabetes. The individual contribution of ethnicity, obesity, and genetics to type 2Y~     have yet to be elucidated. There is no consensus regarding treatment with type 2Y diabetes.~     Observation of our Hispanic patients in the Houston area reveals a large number with type 2Y.~     The major purpose of this study is to examine the genetic and environmental risk factors such~     as family history, ethnicity, and obesity in Hispanic children with type 2Y diabetes.~     SPECIFIC AIMS: 1) To examine the genetic and environmental risk factors and clinical signs~     associated with type 1 diabetes and type 2 diabetes of youth. 2) To compare the efficacy of~     the treatment modalities, insulin and oral agents, in type 2Y patients. METHODS: We will~     undertake a retrospective case study, to include a review of hypothesized risk factors in all~     the medical records of pediatric diabetes patients seen at University of Texas. We anticipate~     that approximately 200 patients with type 1 diabetes and 30 patients with type 2Y diabetes~     will be identified. A Sustacal challenge test will be done in patients with a suspected~     diagnosis of type 2Y in order to confirm the clinical diagnosis. Parents will be contacted by~     phone for a detailed pedigree intake. Type 1 and type 2Y patients will be compared for each~     of the studied features. A retrospective review of diabetes type 2 therapies used in type 2Y~     patients will be undertaken through further examination of the medical records in order to~     compare insulin treatment to oral agents. We will also test a subset of the patients for the~     gene identified in adult Hispanics with type 2 diabetes.~   "
274939|NCT00000604|"~     To compare three accepted modes of myocardial preservation, warm, tepid, and cold blood~     cardioplegia, coinciding with normothermic (37 degrees centigrade), tepid (32 degrees~     centigrade) and hypothermic (8 to 10 degrees centigrade) cardiopulmonary bypass (CPB) to~     define differences in neurologic function in coronary artery bypass graft (CABG) patients.~   "
274336|NCT00004571|"~     The purpose of this study is to use brain imaging technology to compare differences in brain~     structure, chemistry, and functioning in individuals with brain and mental disorders compared~     to healthy volunteers.~      Schizophrenia is a brain disorder that results from subtle changes and abnormalities in~     neurons. These deficits likely occur in localized regions of the brain and may result in~     widespread, devastating consequences. The neuronal abnormalities are inherited through a~     complex combination of genetic and environmental factors. Brain imaging technologies can be~     used to better characterize brain changes in individuals with schizophrenia. This study will~     use magnetic resonance imaging (MRI) scans to identify predictable, quantifiable~     abnormalities in neurophysiology, neurochemistry and neuroanatomy that characterize~     schizophrenia and other neurological and neuropsychiatric disorders.~   "
274337|NCT00004570|"~     Some children with certain language disorders may not properly process the sounds they hear,~     resulting in language impairments. The purpose of this study is to determine if deficits in~     auditory temporal processing the way the brain analyzes the timing and patterns of sounds are~     an inherited trait.~      Families with auditory temporal processing deficits are sought in order to identify the genes~     responsible for auditory temporal processing deficits. Children and adults with a diagnosis~     or history of language impairment in the family and their family members both affected and~     non-affected are eligible for this two-part study. In Part 1, participants undergo a series~     of language tests and listening tests to measure various characteristics of how they perceive~     sound. In Part 2, they are interviewed about language disorders, learning disabilities, and~     other medical problems of family members. This information is used to construct a pedigree~     (family tree diagram) showing the pattern of inheritance of family traits. Study subjects~     whose pedigree indicates that language disorders may be hereditary in their family will~     provide either a small blood sample (1 to 2 tablespoons) or a tissue specimen obtained from a~     cheek swab (rubbing the inside of the cheek with a small brush or cotton swabs). The sample~     will be used to isolate DNA for genetic analysis.~   "
274338|NCT00004569|"~     The diagnosis and treatment of sleep disordered breathing have come to the forefront of~     clinical medicine following recognition of the high prevalence and associated morbidity of~     sleep apnea. The effects on quality of life as well as societal costs have been well~     documented. The NYU Sleep Research Laboratory has spent the last several years working on the~     problem of improving the diagnosis of mild sleep disordered breathing which manifests as the~     upper airway resistance syndrome. Our approach has been to develop a non-invasive technique~     to detect increased upper airway resistance directly from analysis of the airflow signal. A~     characteristic intermittent change of the inspiratory flow contour, which is indicative of~     the occurrence of flow limitation, correlates well with increased airway resistance.~      Currently all respiratory events are identified manually and totaled. This is time consuming~     and subject to variability. The objective of the present project is to improve upon the~     manual approach by implementing an artificially intelligent system for the identification and~     quantification of sleep disordered breathing based solely on non-invasive cardiopulmonary~     signals collected during a routine sleep study. The utility of other reported indices of~     sleep disordered breathing obtained during a sleep study will be evaluated.~      Successful development of an automated system that can identify and classify upper airway~     resistance events will simplify, standardize and improve the diagnosis of sleep disordered~     breathing, and greatly facilitate research and clinical work in this area. Using a~     physiological based determination of disease should allow better assessment of treatment~     responses in mild disease.~   "
274339|NCT00004568|"~     This study is designed to learn more about the natural history of inherited neurological~     disorders and the role of heredity in their development. It will examine the genetics,~     symptoms, disease progression, treatment, and psychological and behavioral impact of diseases~     in the following categories: hereditary peripheral neuropathies; hereditary myopathies;~     muscular dystrophies; hereditary motor neuron disorders; mitochondrial myopathies; hereditary~     neurocognitive disorders; inherited neurological disorders without known diagnosis; and~     others. Many of these diseases, which affect the brain, spinal cord, muscles, and nerves, are~     rare and poorly understood.~      Children and adults of all ages with various inherited neurological disorders may be eligible~     for this study. Participants will undergo a detailed medical and family history, and a family~     tree will be drawn. They will also have a physical and neurological examination that may~     include blood test and urine tests, an EEG (brain wave recordings), psychological tests, and~     speech and language and rehabilitation evaluations. A blood sample or skin biopsy may be~     taken for genetic testing. Depending on the individual patient s symptoms, imaging tests such~     as X-rays, CT or MRI scans and muscle and nerve testing may also be done.~      Information from this study may provide a better understanding of the genetic underpinnings~     of these disorders, contributing to improved diagnosis, treatment, and genetic counseling,~     and perhaps leading to additional studies in these areas.~   "
274340|NCT00004567|"~     This study will compare the safety and effectiveness of two drugs-methotrexate and~     mycophenolate mofetil (MPM)-in preventing disease recurrence in patients with Wegener's~     granulomatosis and related inflammatory blood vessel disorders. The standard treatment for~     these conditions is combination drug therapy with prednisone plus cyclophosphamide. However,~     although most patients improve on this therapy and achieve disease remission, many experience~     a relapse (return of the disease) some time after therapy is stopped. Also, these drugs can~     produce serious side effects during treatment. This study will test a new treatment regimen~     to try to maintain disease remission in these patients with minimal side effects.~      Patients with Wegener's granulomatosis or other related blood vessel disorders between 10 and~     80 years old will be considered for this study. All participants will start therapy with~     daily doses of prednisone and cyclophosphamide. Prednisone will be reduced gradually and then~     stopped after symptoms improve significantly. Cyclophosphamide will continue until the~     disease is in remission. Patients in remission will then be randomly assigned to continue~     treatment with either MPM or methotrexate. MPM is taken twice a day by mouth. Methotrexate is~     taken once a week, usually by mouth, but in some cases, by injection into a muscle or under~     the skin. Patients who do well and have no side effects will continue treatment for 2 years.~     Then, the drug will gradually be reduced (usually at monthly intervals) and finally stopped.~     No further treatment will be given unless a relapse occurs. At that time, the type of~     treatment will depend on various medical factors, including the severity of the recurrence~     and the patient's history of drug side effects.~      Physical examinations and various tests, including blood and urine analyses, and X-rays, will~     be done periodically to evaluate the response to treatment and monitor drug side effects. The~     total duration of the study-from the screening evaluation through a 2-year follow up after~     all medications have been stopped-is about 5 to 6 years.~   "
274800|NCT00001178|"~     The Cognitive Neuroscience Section of the National Institute of Neurological Disorders and~     Stroke proposes to continue its cross-sectional and longitudinal studies of cerebral~     metabolism in frontal lobe dementias and atypical basal ganglia disorders. These studies~     include repeated assessments of neuropsychological and brain anatomical and metabolic~     function in subjects with these important and possibly related brain disorders....~   "
274341|NCT00004566|"~     This study will establish a database of fetal movements associated with feeding. It will use~     information obtained from standard fetal ultrasound procedures to identify and measure the~     growth of the baby's face, lips, tongue, jaw, throat and airway. Fetal movements involved in~     breathing, sucking and swallowing will be recorded on videotape. This study may provide~     information that will:~      increase knowledge about how swallowing develops in the fetus;~      help explain why some babies have difficulty sucking and swallowing at birth; help predict~     what babies are at increased risk for feeding problems; and help design better ways to manage~     feeding difficulties in babies.~      Pregnant women scheduled for ultrasound examination at the National Naval Medical Center in~     Bethesda, Maryland, or Georgetown University Hospital in Washington, D.C., are eligible for~     this study. Mothers will fill out a questionnaire providing general medical and health~     information. For the ultrasound procedure, a transducer (a small, wand-like device) is moved~     across the belly to produce images of the fetus. When the baby is awake and swallowing,~     images of the mouth, throat and air passages will be recorded on videotape. The movements~     associated with feeding-breathing, sucking, yawning and swallowing-will then be measured to~     document how swallowing develops.~      When the baby is born, researchers will review the medical chart for any findings relevant to~     this study. One to 2 weeks after delivery, the mother will be interviewed by telephone about~     the baby's feeding skills. Follow-up visits at 4 and 8 weeks after the birth will include~     observation of the baby's sucking and swallowing and an ultrasound examination, in which the~     transducer is held under the baby's chin during swallowing.~      Babies who show signs of slow sucking or swallowing development will have a follow-up~     examination at ages 4 and 8 months. Follow-up visits at 4 and 8 months after the birth will~     include observation of the baby's sucking and swallowing and an ultrasound examination, in~     which the transducer is held under the baby's chin during swallowing.~   "
274342|NCT00004565|"~     This study will explore whether different forms, or variants, of genes are related to a~     person s risk of developing breast cancer. The genes that are looked at have no clinical~     significance today, and thus will not impact your personal healthcare at this time. However,~     these results may help researchers better understand why some people develop breast cancer~     and others do not. The study will try to determine:~      if people with breast cancer have different gene variants from people without the disease;~      if these genetic differences influence a person s susceptibility to breast cancer when they~     are exposed to certain environmental substances, such as nicotine and estrogen; and~      if breast cancer that occurs in families is related to a grouping of these variants.~      The study will also look for certain proteins, cells, or other substances in fluid aspirated~     (by the use of gentle suction; no needles) from the nipple that might represent a pattern, or~     fingerprint, indicating increased risk for breast cancer.~      Study participants will complete questionnaires on cancer risk factors, diet, and family~     history. A small blood sample (3 tablespoons) will be drawn for study of genetic differences~     between people with breast cancer and people who are cancer-free. Nipple aspirations, a~     noninvasive method to obtain fluid from a women s breast, will be attempted 4 to 6 times,~     over a 4 6 week period. For this procedure, the subject places a warm moist towel over the~     breasts for about 20 minutes. The breasts are then cleansed with a rubbing alcohol pad. The~     subject compresses the breast with both hands and a small plastic cup is inverted over the~     breast. Suction is applied to a small syringe (no needles) attached to the cup for about 15~     seconds. The procedure may be repeated up to 5 times on each breast. Any drops of fluid~     obtained from the nipple will be collected in a glass tube.~   "
274343|NCT00004564|"~     The objective of this study is to determine if the action of the drug called clopidogrel,~     that you will start taking, will be decreased by another drug called atorvastatin, that you~     will also start taking. Clopidogrel is an oral antiplatelet agent that has been shown to~     prevent strokes and heart attacks. Atorvastatin is a cholesterol lowering agent.~      Twenty adults 18-75 years of age requiring cholesterol-lowering agent and antiplatelet agent~     therapy will be recruited for this study during their cardiology clinic visitation. In one~     group, antiplatelet agent (clopidogrel) regimen will be administered first, then followed by~     cholesterol-lowering medication (atorvastatin). In the second group, atorvastatin will be~     administered first, followed by clopidogrel.~      A new test called the erythromycin breath test will be administered to you three times during~     the study to measure how your liver will metabolize these drugs. Blood samples will also be~     obtained to assess platelet function. The criteria for exclusion are patient refusal or~     inability to give written consent, patients with allergic reaction to erythromycin, patients~     with known bleeding problems, liver disease, significant lung disease kidney disease and~     pregnancy. Patients with psychiatric impairment and documented history of substance abuse~     will also be excluded from the study.~   "
274344|NCT00004563|"~     To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and~     progression of symptomatic pulmonary disease in patients with systemic sclerosis.~   "
274345|NCT00004562|"~     The purpose of this study is to determine whether opening an occluded infarcted artery 3-28~     days after an acute myocardial infarction in high-risk asymptomatic patients reduces the~     composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for~     class IV congestive heart failure over an average 2.9-year follow-up with extended follow up~     for an average of six years. Long term follow-up of patients were completed in March 2010.~     Final collection of all regulatory documentation was completed June 2011.~   "
274346|NCT00004561|"~     To determine whether exercise training could significantly replace medication as a treatment~     for mild essential hypertension.~   "
274347|NCT00004560|"~     To measure survival to hospital discharge of patients with out-of-hospital cardiac arrest in~     community units (e.g., apartment or office buildings, gated communities, sports venues,~     senior centers, shopping malls) served by trained non-medical responders using automated~     external defibrillators (AEDs), an approach called Public Access Defibrillation, compared to~     units receiving the traditional optimum community standard of care (i.e., rescuers trained to~     recognize a cardiac emergency, call 911, and initiate CPR).~   "
274348|NCT00004559|"~     To determine if the dietary N-3 class of polyunsaturated fatty acids (PUFAs) provided in the~     diet largely from marine fish oils would prevent fatal ventricular tachycardia (VT) or~     ventricular fibrillation (VF).~   "
274349|NCT00004558|"~     To determine the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted~     defibrillators.~   "
274350|NCT00004556|"~     The purpose of this study is to determine the effects of the drug dextroamphetamine on the~     brain function and mood of healthy volunteers.~      Monoaminergic drugs are substances that affect the nervous system; these drugs can raise,~     hamper, or have no effect on brain function when given to healthy individuals. Different~     responses to a drug may be the result of genetic variations. This study will examine the~     effects of the monoaminergic drug dextroamphetamine on thought and sensorimotor processes~     while participants perform a variety of tasks.~      Participants in this study will undergo a medical history, physical examination, blood tests,~     and an electrocardiogram (EKG). Women of reproductive potential will undergo a pregnancy~     test. Participants will be given either dextroamphetamine or placebo (an inactive solution)~     on two occasions separated by at least 3 to 7 days. Participants will then perform~     neuropsychological tests that will measure attention, problem solving, memory, and ability to~     complete simple motor tasks.~   "
274872|NCT00000449|"~     The study's purpose is to improve alcoholism treatment by investigating the combined~     effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET)~     with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or~     a control treatment as inpatients followed by 12 consecutive weeks of receiving either~     naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is~     completed.~   "
274352|NCT00004553|"~     This study will investigate problems with muscle weakness and control using~     electromyography-a test of nerve-muscle cell communication. Advanced techniques called single~     fiber electromyography and macro-electromyography, which evaluate individual muscle fibers,~     will be used. Besides aiding in diagnosis, these tests provide information about disease~     progression that may be useful in guiding therapy.~      Adult patients with suspected neurological disorders of muscle control and weakness may be~     eligible for this study. Normal volunteers may also participate. For the electromyography~     procedure, a special needle is inserted into a muscle. The patient will slightly tense the~     muscle and maintain the tension while electrical signals from the muscle fibers are being~     recorded. The electrical signals are played through a loudspeaker, providing feedback to help~     the patient tense the muscle the appropriate amount. The test, which is usually done for only~     one muscle, takes 1 to 2 hours. If needed, short breaks can be taken.~      If the patient cannot maintain tension in the muscle for the entire test period, a nerve will~     be stimulated to activate the muscle. A thin needle is inserted near the nerve, and a series~     of small electrical shocks are given to activate a nerve fiber. The electromyography needle~     is inserted into the muscle to measure the response, as described above.~      A neurologist receiving specialized training in clinical neurophysiology will do the~     electromyography procedure under the direct supervision of an experienced neurologist.~   "
274353|NCT00004552|"~     This study will examine whether pretreatment with two doses of acamprosate for seven days~     prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a~     placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate~     or placebo for seven days. This will be followed by a four- day inpatient period when~     withdrawal will be monitored. Additional drinking information will be obtained at a three~     month followup interview.~   "
274354|NCT00004551|"~     This study is to evaluate the effectiveness of a mood management intervention on abstinent~     alcoholic smokers with a history of major depression. The second aim is to determine the~     effect of smoking treatments on alcohol abstinence and to identify factors associated with~     smoking and alcohol outcomes (e.g., more days of abstinence). A randomized, two-group design~     will be used to evaluate the added benefit of mood management compared to a state-of-the-art~     smoking cessation treatment. Treatment will consist of 8 weekly group sessions and 1, 3, 6,~     and 12-month follow-up.~   "
274355|NCT00004550|"~     The purpose of this study is to better understand the long-term progress of people with~     obsessive-compulsive disorder (OCD) and related conditions such as anorexia nervosa, Tourette~     syndrome, and trichotillomania.~      This study involves the screening and follow-up of individuals with OCD and OCD-related~     disorders. Participants will be screened with a medical and psychiatric evaluation,~     questionnaires, and neurological testing. Participants will then have study visits every 4 to~     12 weeks to undergo symptom and daily functioning evaluations, personality tests, blood and~     urine tests, memory tests, brain scans, and other clinical exams. Participants will be~     assessed with interviews and paper-and-pencil or computer-assisted tests. Participants may~     have the opportunity to participate in drug studies and to join a monthly OCD support group.~     At the end of the study, participants will be referred to community or private treatment~     centers.~   "
274356|NCT00004549|"~     This study will examine the use of magnetic resonance imaging (MRI) in detecting blood vessel~     inflammation. The results of this study may later be applied to diagnosing inflammation of~     arteries in patients with atherosclerosis, predicting disease progression in these patients,~     and guiding therapy.~      Patients with peripheral artery disease (for example, blockage of a leg artery) undergoing~     balloon angioplasty at Suburban Hospital in Bethesda, Maryland, may be eligible to~     participate in this study. Because this procedure, which opens blocked arteries, can cause~     inflammation in the vessel wall, it affords an opportunity for studying MRI detection of such~     inflammation.~      Study candidates will be screened with a medical history and physical examination.~     Participants will have a MRI scan and blood drawn at Suburban Hospital before the angioplasty~     and again either 1 to 3 days or 2 weeks after the procedure. Before the MRI scan is begun, a~     catheter (a thin plastic tube) is inserted in an arm vein and 90 milliliters (about 3 ounces)~     of blood is drawn. The patient then lies on a table that slides into the MRI scanner-a large~     donut-shaped machine with a magnetic field. A flexible, padded sensor called an MRI coil is~     placed over the area to be imaged; this device is used to improve the quality of the~     pictures. During the scan a contrast material called gadolinium is injected through the~     catheter. Gadolinium brightens the image of the blood vessels. The procedure lasts up to 2~     hours.~   "
274357|NCT00004547|"~     This study will test the effectiveness of an experimental treatment for peritoneal cancer~     involving surgical removal of the tumor, perfusion of the abdomen during surgery with a~     heated solution of the drug cisplatin, and post-surgery combination chemotherapy in the~     abdomen with fluorouracil (5-FU) and paclitaxel.~      Patients with certain peritoneal cancer whose tumors are confined to the abdomen may be~     eligible for this study. Candidates are screened with a medical history and physical~     examination, including blood tests, electrocardiogram and possibly bone scan, brain magnetic~     resonance imaging (MRI), and chest, abdomen and pelvic CT scans.~      Participants undergo surgery to remove as much tumor as possible. Part of the intestines,~     pancreas, stomach or the entire spleen may also be removed if they are affected. During~     surgery, after the tumor has been removed, two catheters (thin plastic tubes) are placed in~     the abdomen. A chemotherapy solution containing the anti-cancer drug cisplatin heated to a~     temperature of about 108.6 degrees (10 degrees above normal body temperature) is then~     delivered into the abdomen through one catheter and drained through another. During~     treatment, a drug called sodium thiosulfate is given through a vein to reduce the risk of~     side effects of cisplatin, particularly kidney damage. After 90 minutes of bathing the~     abdomen with this solution, the drug is rinsed from the abdomen and the catheters removed.~     Another small catheter is then placed and left inside the abdomen with one end coming out~     through the skin. Seven to 12 days after the operation, the anti-cancer drugs 5-FU and~     paclitaxel are given through this catheter.~      After complete recovery from the surgery, the catheter is removed and the patient is~     discharged from the hospital. Clinic visits are scheduled for periodic follow-up examination,~     imaging, and tests 3 and 6 months after surgery and every 6 months for up to 5 years as long~     as the disease does not worsen. Patients whose disease progresses are taken off the study and~     referred back to their local physician or referred for alternative care or other research~     studies.~      Patients are also asked to assess how this therapy affects their general health and well~     being. This will require filling out two quality-of-life (QOL) questionnaires before surgery~     and again at each follow-up visit after surgery. Each questionnaire takes about 15 minutes to~     complete.~   "
274358|NCT00004533|"~     OBJECTIVES:~      I. Determine the maximum tolerated dose of recombinant adeno-associated virus-CFTR vector in~     patients with cystic fibrosis.~      II. Assess the safety of this gene therapy in these patients.~      III. Assess the in vivo gene transfer of this vector in these patients.~      IV. Assess the CFTR gene expression and physiologic activity following gene transfer in these~     patients.~      V. Assess the clinical impact of CFTR gene expression following gene transfer in these~     patients.~      VI. Monitor patient immune response directed against CFTR or vector components following~     vector administration.~   "
274359|NCT00001987|"~     The study will allow researchers to obtain blood, plasma, DNA, and RNA for genetic studies of~     insulin. There will be a focus on the causes of insulin resistance and diabetes mellitus.~     Insulin is a hormone found in the body that controls the level of sugar in the blood. Insulin~     resistance refers to conditions like diabetes when insulin does not work properly. In this~     study researchers would like to compare patients with diabetes and other forms of insulin~     resistance to normal individuals. The study will investigate how insulin attaches to cells.~      Researchers will take 4 to 6 ounces (100-150 ml) of blood from adult patients and may request~     up to 12 ounces (one unit) of blood if necessary. Skin samples may be taken for a biopsy if~     further genetic testing is necessary. In addition some patients may be asked not to eat for~     up to 72 hours prior to testing.~   "
274360|NCT00000436|"~     This project will assess the effectiveness of a novel approach involving patient education~     and strength training to improve functional recovery after a hip fracture. Participants will~     be randomly assigned to one of two study groups. One group (control group) will receive~     standard medical care. The other group will participate in a program of patient education and~     strength training, including an at-home walking program.~   "
274361|NCT00001985|"~     Type 1 diabetes mellitus is an autoimmune disease in which the body's immune cells attack the~     insulin-producing cells of the pancreas. Several environmental and genetic factors may~     predispose individuals to developing this disease, including changes in a gene called CD152.~     This study will examine how this gene may influence the development of insulin-dependent~     diabetes.~      Patients with Type 1 diabetes mellitus enrolled in clinical trials at the National Institutes~     of Health and at the University of Florida and healthy normal volunteers may participate in~     this study. Participants will have up to three blood samples drawn over a period of less than~     1 year. The first sample (about 20 milliliters, or 4 teaspoons), will be examined for changes~     in the structure of the CD152 gene. If the CD152 structure is different from that normally~     seen in the general population, a second sample (about 90 ml, or 6 tablespoons of blood) will~     be drawn. This sample will be used to study the function of specialized immune system cells~     (T cells), including their growth and survival, chemicals they produce when stimulated, and~     other factors. If these cells function differently from what is generally seen in the~     population, a third sample (90 ml) will be drawn for more detailed studies.~      This investigation may help explain what makes certain individuals susceptible to Type 1~     diabetes mellitus and may contribute to the development of improved treatments for the~     disease.~   "
274362|NCT00001984|"~     This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability~     to induce a state of permanent allograft acceptance, or tolerance, when administered in~     combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the~     time of human renal allotransplantation. Campath-1H is specific for the common lymphocyte and~     monocyte antigen CD52. Its administration temporarily depletes mature lymphocytes and some~     monocytes without altering neutrophils or hematopoietic stem cells. Deoxyspergualin inhibits~     the NFkB pathway thus preventing monocyte and macrophage activation.~      Recipients of living or cadaveric donor kidneys will be treated with one dose of Campath-1H~     prior to transplantation to insure that peripheral depletion is achieved at the time of graft~     reperfusion. Three subsequent doses of Campath-1H will be administered on the first, third~     and fifth days after the transplant to deplete passenger donor leukocytes and residual~     recipient cells that mobilize in response to the allograft. In addition, patients will be~     treated with DSG for 14 days beginning on the day prior to surgery. This trial expands on~     pilot studies at the NIH of 15 patients in which Campath was given alone at the time of~     transplantation. In those studies, excellent peripheral depletion occurred after just one~     dose of Campath though central depletion required additional dosing. This allowed for greatly~     reduced immunosuppression to be used to prevent rejection, but to date, all patients have~     required some immunosuppressive medication. It is hoped that the addition of DSG will~     eliminate the need for long-term immunosuppression.~      Patients will be followed closely in the post transplant period. If patients experience~     rejection, they will be treated with methylprednisolone and have immunosuppression added~     using sirolimus as the predominant immunosuppressive agent. In the previous phase of this~     study without DSG, this maneuver has in all cases been successful in returning the allograft~     to normal function.~      In addition to evaluating graft function following transplantation, this protocol will also~     characterize and evaluate the function of the immune system and the composition of the T cell~     repertoire following the administration of Campath-1H and DSG, and during immune system~     recovery after transplantation.~   "
274363|NCT00001983|"~     This screening protocol is designed to evaluate patients for participation in clinical~     studies in the Gene Therapy and Therapeutics Branch (GTTB) of the National Institute of~     Dental and Craniofacial Research. To participate, patients must meet the specific~     requirements of at least one of the available research studies; this protocol serves as a~     first step for admitting patients to an appropriate program.~      People with diagnosed or undiagnosed conditions may participate in this screening protocol.~     They will undergo procedures that may include questionnaires, a physical examination, routine~     laboratory tests, and diagnostic imaging or radiological studies. Eligibility screening will~     be limited to three visits within 12 months of entry into the protocol. If an appropriate~     study is not found by the end of this time, the candidate's participation in the screening~     program will terminate. No experimental treatments are offered under the screening protocol.~      Patients who are found eligible for a current GTTB study will be notified of their options~     and invited to enroll.~   "
274364|NCT00001981|"~     The purpose of this study is to investigate the treatment and natural history of acromegaly.~     We have a longstanding interest in acromegaly treatment, and a cohort that has been followed~     for 30 years, or more in some cases. We will continue to follow patients and recruit new~     patients for treatment and follow-up. Blood and pituitary tumor tissue (when available~     through clinical care) will be saved for future analyses related to acromegaly.~   "
274365|NCT00000435|"~     A small protein called dnaJ peptide may help people with rheumatoid arthritis (RA) by~     preventing their immune system cells from attacking their own tissues. The purpose of this~     study is to determine if small amounts of dnaJ peptide can re-educate immune cells in~     people with RA so that the cells stop attacking joint tissues.~   "
274372|NCT00001972|"~     The main source of energy for the brain comes from a combination of oxygen and glucose~     (sugar). For brain cells to function normally they must receive a constant supply of these~     nutrients. As areas of the brain become more active blood flow into and out of these areas~     increase.~      In addition to oxygen and glucose, the brain uses chemical compounds known as phospholipids.~     These phospholipids make up the covering of nerve cells that assist in the transfer of~     information from cell to cell. Without phospholipids brain cell activity may become abnormal~     and cause problems in the nervous system.~      Certain diseases like Alzheimer's disease and brain tumors can affect blood flow to the brain~     and change the way the brain metabolizes phospholipids. In addition to diseases, changes in~     the brain occur with normal healthy aging.~      This study is designed to use PET scan to measure changes in blood flow and changes in~     phospholipid metabolism. Using this technique, researchers can improve their understanding of~     how certain diseases change the shape and function of the brain.~   "
274366|NCT00000434|"~     Previous studies have found that exercise can reduce pain, improve endurance for physical~     activities, and improve cardiovascular fitness over time. However, these studies have not~     looked at the impact of exercise programs for older adults with osteoarthritis or at how long~     older adults continue exercising after a program is finished. This study will look at the~     long-term effects of a structured exercise program for people aged 60 or older who have~     osteoarthritis of the hip or knee. One goal of the exercise program is to encourage older~     people with osteoarthritis to continue exercising.~      We will randomly assign study participants to either the exercise program or a control group~     that does not do the exercise program. We will monitor participants at the start of the~     study, at 8 weeks, and every 3 months for 2 years after the program is completed. The~     exercise program lasts for 8 weeks and includes an exercise part and an educational part led~     by trained physical therapists. We believe that participants in the treatment (exercise)~     group will show higher rates of continued exercise and higher functional status over time~     compared to the group of people who do not participate in the exercise program.~   "
274367|NCT00001979|"~     Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis,~     membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue~     disorders.~      This study will allow researchers to admit and follow patients suffering from autoimmune~     diseases of the kidney. It will attempt to provide information about the causes and specific~     abnormalities associated with autoimmune kidney disease.~      Patients with kidney disease as a result of their immune system, and patients with diseases~     of the immune system who may later develop kidney disease, will be potential subjects for~     this study.~      Patients will undergo a history and physical examination, and standard laboratory test to~     more closely understand the causes, signs, symptoms, and responses to medication of these~     diseases. Based on these evaluations the patients may qualify as candidates for other~     experimental studies. At any time these patients may be asked to submit blood or urine~     samples for further research.~   "
274368|NCT00001978|"~     Much more about kidney disorders can be learned by determining kidney function. This research~     proposes to study the kidneys function by several parameters known as glomerular filtration~     rate (GFR), Renal Plasma Flow (RPF), and Glomerular Capillary Wall Permselectivity.~      The study will select patients suffering from different types of kidney diseases. These~     patients will be selected based on the presence of significant amounts of protein in their~     urine (proteinuria).~      Standard blood and urine tests are often unable to provide completely accurate information~     about the kidney. In order for researchers to have a more accurate idea of kidney function,~     they will use alternative tests. Test materials (para aminohippurate and inulin) will be~     injected into patients veins that provides information based on their filtration through the~     kidneys.~   "
274369|NCT00001976|"~     This study will evaluate the reliability of a new test called Real-Time Polymerase chain~     reaction (RT PCR) in detecting cytomegalovirus (CMV) in the blood and predicting the course~     of CMV disease in patients who have recently had a bone marrow transplant. The test's~     effectiveness will be compared with that of the pp65 antigenemia assay now routinely used~     for this purpose.~      CMV is a common virus that is transmitted from person to person by close personal contact. In~     most healthy people, CVM can remain in the body indefinitely without causing any harm. But,~     in people with weakened immune systems-including those who have just undergone bone marrow~     transplant-CMV infection can cause serious, and possibly fatal, complications. Drugs are~     available to treat this infection, however. Optimum treatment depends on early and accurate~     detection.~      Patients aged 10 to 80 years who are scheduled to undergo bone marrow transplant at the NIH~     Clinical Center as part of an NIH protocol may be eligible for this 2-phase study. In phase~     1, patients will have blood drawn for both RT PCR and antigenemia testing once before the~     bone marrow transplantation and then weekly for the first 100 days after the transplant.~     During Phase 2-which begins immediately after the end of phase 1 and continues for one year~     after the transplant-blood samples for both tests will be drawn up to once a week. The~     samples for both tests will be collected at the same time and will be taken through a~     catheter (a thin flexible tube inserted into a vein) that has already been placed for the~     transplant study. RT PCR testing will require an extra 5 milliliters (1 teaspoon) above what~     is needed for antigenemia testing, amounting to a maximum of about one-half pint extra over~     the course of the 1-year study.~      It is hoped that the new RT PCR test will prove to be more accurate in detecting CMV~     infection and predicting disease development, thus enabling doctors to plan early and~     effective treatment.~   "
274370|NCT00001975|"~     Tuberous sclerosis is a rare, hereditary disease in which patients develop multiple tumors.~     Although not cancerous, the tumors can affect various organs, including the heart, lungs,~     kidneys, skin, and central nervous system, with serious medical consequences. The severity of~     disease varies greatly among patients, from barely detectable to fatal. This study will~     investigate what causes skin tumors to develop in patients with this disease.~      Patients with tuberous sclerosis 18 years and older may enroll in this study. Participants~     will undergo a medical history and thorough skin examination by a dermatologist. Those with~     skin tumors will be asked to undergo biopsy (tissue removal) of up to eight lesions, under a~     local anesthetic, for research purposes. The biopsies will all be done the same day. The~     tissue samples will be used for: examination of genetic changes, measurement of certain~     proteins and other substances, and growing in culture to study the genetics of tuberous~     sclerosis.~   "
274371|NCT00001973|"~     This study will investigate how a gene mutation (change in DNA) causes the abnormal bone in~     fibrous dysplasia-a condition in which areas of normal bone are replaced with a fibrous~     growth similar to a scar. The bone abnormalities in fibrous dysplasia can occur in a single~     bone (monostotic fibrous dysplasia), multiple bones (polyostotic fibrous dysplasia), or in~     McCune Albright syndrome, in which there are associated glandular abnormalities. This study~     will also examine calcinosis samples that have been surgically removed from patients with~     juvenile dermatomyositis.~      Patients who are scheduled to have orthopedic surgery for treatment of polyostotic fibrous~     dysplasia may participate in this study. A small sample of bone tissue removed during surgery~     will be given to investigators in this study for research tests. DNA will be extracted from~     the tissue and tested for the mutation. Investigators will attempt to grow cells from the~     sample in the laboratory to evaluate them for their ability to grow and make proteins that~     normal bone cells make. These tests are designed to help scientists understand how the~     mutation leads to abnormal bone formation and provide information that might lead to better~     treatments for fibrous dysplasia. Patients with juvenile Dermatomyositis who have a~     calcinosis sample surgically removed are also eligible for participation. The removed tissues~     will be examined for their composition and microscopic appearance, to better understand the~     pathogenesis of dystrophic calcification in this disease.~   "
275024|NCT00000519|"~     To determine the effects in moderately obese subjects of weight loss by combined dieting and~     exercise training on risk factors for coronary artery disease including lipoprotein lipids,~     apoproteins and blood pressure.~   "
274373|NCT00001971|"~     The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute~     and chronic liver disease. The study will focus on understanding diseases affecting the~     liver.~      Patients participating in the study will first undergo a routine check-up as an outpatient.~     They will be asked to provide blood and urine samples for laboratory testing and will undergo~     an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and~     texture of the liver. After the initial visit subjects will be requested to follow-up once a~     year at the outpatient department for a similar check-up.~      Additional tests may be requested throughout the study to provide information for other~     research studies and individual consent will be requested. These tests may include liver~     biopsies, skin biopsies, and / or specialized blood, plasma, and lymphocyte examinations.~      Subjects that qualify for medications presently being studied may be offered the opportunity~     to benefit from experimental therapy.~   "
274374|NCT00001969|"~     A series of studies in patients with major depression have consistently demonstrated a~     doubling of the mortality rate at any age, independent of suicide. In addition, the relative~     risk for clinically significant coronary artery disease in patients with major depression is~     also 2 or more in studies that independently controlled for risk factors such as smoking,~     hypertension, etc. The principal long-term goals of the CNE include the determination of the~     mechanisms that underlie enhanced susceptibility to premature ischemic heart disease in~     patients with major depression, documenting the age at which demonstrable pathophysiologic or~     predictive changes begin to occur, and charting their rate of progression. Our long-term goal~     is to use our understanding of underlying mechanisms to enhance our capacity to predict who~     with major depression is most likely to develop premature ischemic heart disease, to~     determine what the mechanisms underlying this susceptibility are, and to develop improved~     means for treatment and prevention.~      Depressed patients are known to manifest a variety of neuroendocrine changes that predispose~     to coronary artery disease including hypercortisolism, decreased secretion of growth hormone~     and a deficiency of sex steroids. A final common denominator of these neuroendocrine~     abnormalities is insulin resistance. Insulin resistance promotes several changes that would~     favor hypertension and increased coronary artery disease including increased sodium~     retention, increased activity of the sympathetic nervous system, proliferation of vascular~     smooth muscle and deposition of highly metabolically active visceral fat. The latter induces~     additional risk factors for coronary disease, including dyslipidemia, hypercoagulation, and~     enhanced inflammation. It is a matter of public health importance to document the frequency~     and severity of insulin resistance in patients with major depression compared to a closely~     matched group of healthy controls. To accurately quantify insulin resistance in each patient~     and control, we will apply the hyperinsulinemic euglycemic glucose clamp procedure. This is~     the gold standard method for measuring the insulin sensitivity since it reflects the direct~     human body glucose metabolic response to a known insulin infusion. Moreover, it is essential~     to use this technique in patients with major depression as data indicate that other~     alternative procedures give unreliable results in the context of hypercortisolism.~   "
274375|NCT00001967|"~     Although highly active antiretroviral therapy (HAART) has been successful in suppressing~     plasma HIV RNA levels in infected patients, it has not resulted in eradication of virus. It~     is now clear that virus replication persists despite undetectable plasma viremia in~     individuals receiving HAART. In this regard, withdrawing HAART, even after prolonged periods~     of virus suppression, leads to an almost universal rapid rebound of plasma viremia. It is~     also now clear that prolonged, continuous HAART carries a risk of significant toxicity and~     side effects. These recent observations may argue for a different approach to HAART with the~     goals of: 1) durable suppression of virus replication, without an attempt at eradication, and~     2) minimization of toxicity and side effects and improvement in patient life-style.~     Therefore, we propose to study the virologic and immunologic effects of intermittent versus~     continuous HAART in HIV-infected individuals as a possible means to achieve these goals. The~     primary protocol, Cohort 1, will be a randomized controlled study of 35 individuals receiving~     continuous HAART and 35 individuals receiving intermittent HAART with intervals of one month~     off therapy followed by two months on therapy. A second cohort of 10 individuals will serve~     as a pilot of 2 arms of 5 patients each to evaluate the potential of shorter on-off cycles to~     maintain suppression of plasma virus and boost HIV-specific immune responses. An extension of~     Cohort 2 will add 5 patients to the 7 days on/7 days off HAART arm with modified exclusion~     criteria and procedure schedule. We will analyze CD4+ T-cell counts, viral load, incidence of~     toxicity and side effects, HIV-specific immune responses and viral resistance to therapy and~     characterize the virus during rebound plasma viremia.~   "
274376|NCT00001964|"~     This study will test the safety and effectiveness of a combination of three drugs in treating~     severe aplastic anemia and preventing its recurrence. Two drugs used in this trial ATG and~     cyclosporine are standard combination therapy for aplastic anemia. This study will try to~     improve this therapy in three ways: 1) by altering the drug regimen to allow the drugs to~     work better; 2) by reducing the risk of kidney damage; and 3) by adding a third drug~     mycophenolate mofetil to try to prevent disease relapse.~      Patients with severe aplastic anemia who do not have a suitable bone marrow donor or who~     decline bone marrow transplantation may participate in this study. Patients will have a skin~     test for ATG allergy, chest X-ray, blood test, and bone marrow aspiration before treatment~     begins. ATG will then be started, infused through a vein continuously for 4 days. Ten days~     after ATG is stopped, cyclosporine treatment will begin, taken twice a day by mouth in either~     liquid or capsule form and will continue for 6 months. Also, in the first 2 weeks of~     treatment, patients will be given a full dose of corticosteroid (prednisone) to prevent serum~     sickness that could develop as a side effect of ATG therapy. The dosage will be decreased~     after that. Mycophenolate will be started at the same time as ATG, in two daily doses by~     mouth, and will continue for 18 months.~      Patients will be hospitalized at the beginning of the study. During this time, blood will be~     drawn at 3-week intervals and a bone marrow examination will be repeated 3 months after~     treatment has begun. Additional tests, including X-rays may be required. After hospital~     discharge, patients will be followed on an outpatient basis at 3-month intervals. The~     patients own physician will perform blood tests weekly and kidney and liver function tests~     every 2 weeks during cyclosporine therapy. Transfusions may be required initially.~   "
274377|NCT00001962|"~     Participants in this study are suffering from rare and serious blood disorders. In aplastic~     anemia, the bone marrow stops producing red blood cells, platelets, and white blood cells. In~     pure red cell aplasia, the bone marrow stops producing red cells, and in amegakaryocytic~     thrombocytopenic purpura, the bone marrow stops producing platelets.~      Current treatment approaches for these disorders include bone marrow transplant and/or~     immunosuppression. However, bone marrow transplant is not always possible, and~     immunosuppression has serious side effects.~      This study will investigate whether daclizumab can be used to treat these disorders.~     Daclizumab is a genetically engineered human antibody that blocks the interleukin-2 receptor~     on immune cells. It has been used successfully in many transplant patients to reduce the rate~     of organ rejection.~      Participants will undergo a complete history and physical examination. A bone marrow~     aspiration and biopsy will be performed to confirm the type of bone marrow failure. About 5~     tablespoons of blood will be drawn for baseline tests and research purposes. Daclizumab will~     be administered every 2 weeks by vein in a 30-minute infusion. The first dose will be given~     at NIH and the next four may be given at NIH or by the participant's primary hematologist.~     The treatment will last 8 weeks. Participants must also see their referring physician or NIH~     physicians every 2 weeks for blood counts. In the fourth and eighth weeks of the study and at~     the 3-month follow-up visit, 2 tablespoons of blood will be drawn at NIH. At the 1-month~     follow-up visit to NIH, 5 tablespoons of blood will be drawn and another bone marrow~     aspiration and biopsy performed.~      Risks from bone marrow aspiration and biopsy and blood draws include discomfort. Daclizumab~     is usually well-tolerated; however, it may weaken immunity against certain bacteria and~     viruses.~   "
274408|NCT00000392|"~     To evaluate the chemical efficacy and safety of intranasally administered peptide T on~     neurocognitive function in HIV seropositive individuals.~      Previous studies have shown that treatment with peptide T can result in cognitive improvement~     in HIV-infected patients.~      Patients are randomized to receive either peptide T or placebo for the first 6 months. All~     patients then receive open-label peptide T for approximately 6 additional months.~     Neuropsychologic tests are used to determine drug effects.~   "
274378|NCT00001961|"~     This study will assess the value of magnetic resonance imaging (MRI) in detecting heart~     attack and heart attack risk in patients who come to the hospital emergency room because of~     chest pain. It will also investigate whether MRI can help predict the coronary status of~     patients 4 to 6 weeks and 1 year after emergency room admission.~      Patients who come to the emergency room of Suburban Hospital in Bethesda, MD, because of~     chest pain may be asked to enroll in this study if they have not been diagnosed as having a~     heart attack. Participating patients will undergo a MRI scan as soon as emergency room~     doctors determine they are in stable condition. For this procedure, the patient lies on a~     table that slides into the MRI scanner-a large tubular machine with a magnetic field. During~     the scan, a contrast material is injected into the vein. This material brightens the image of~     the heart so that the blood flow can be seen. The scan will show if there are areas of heart~     muscle that received insufficient blood flow. A second scan will be done within 72 hours to~     look for coronary artery blockage that may require treatment. Patients will be followed by~     telephone 4 to 8 weeks after the scans and again 1 year after the scans to ask about any~     significant medical problems that may have occurred during those time periods.~      This study will provide information that may improve emergency treatment of patients with~     acute chest pain by clarifying which patients require immediate medical treatment, which~     should be admitted to the hospital for further evaluation, and which may safely be discharged~     from the hospital.~   "
274379|NCT00001960|"~     A heart condition called hypertrophic cardiomyopathy (HCM) causes abnormal thickening of the~     heart muscle, which obstructs the flow of blood out of the heart. The thickened muscle and~     the obstruction of blood flow are believed to cause chest discomfort, breathlessness,~     fainting, and a sensation of heart pounding. Treatment options for children with HCM include~     medicine, heart operation, and cardiac transplantation. However, there is no evidence that~     medicine prevents further thickening of heart muscle; operations carry the risk of death; and~     donor hearts are not always available. Several studies have shown that pacemaker treatment~     reduces the obstruction and improves heart complaints in patients with HCM. This study~     investigates further the efficacy of pacemaker treatment in children.~      Patients will have exercise tests after treatment with beta blocker and verapamil and will be~     eligible for the study if heart complaints or reduced exercise performance continue.~      A pacemaker that treats slow heart rhythms will be inserted. The patient will be sedated and~     local anesthesia will be administered to numb the area. The procedure takes about an hour.~      The study will last two years. Patients will be placed on one of two pacemaker programs for~     the first year and another the second year. At 3- and 6-month follow-up visits, a pacemaker~     check and echocardiogram will be performed. After 1 year, patients will be admitted to NIH~     for 2 to 3 days for exercise tests, echocardiogram, and cardiac catheterization. Also, the~     pacemaker will be changed to the second program. At 15- and 18-month follow-up visits, a~     pacemaker check and echocardiogram will be performed. After 2 years, patients will again be~     admitted for 2 to 3 days for exercise tests, echocardiogram, and cardiac catheterization. A~     pregnancy test will be given to females of child-bearing age before each cardiac~     catheterization and electrophysiology study.~      At the end of the study, the pacemaker will be set to the program that worked better.~      Risks of pacemaker insertion include lung collapse, infection, blood vessel damage, bleeding,~     heart attack, and death. Risks of cardiac catheterization include infection, bleeding, blood~     clots, abnormal heart rhythms, perforation of the heart, need for surgery, and death.~     However, the safety record for both these procedures at NIH has been excellent. The radiation~     exposure exceeds the NIH radiation guidelines for children, but this exposure in adults has~     not been associated with any definite adverse effects.~   "
274380|NCT00001959|"~     This study will examine the effectiveness of the drug pirfenidone in treating focal segmental~     glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and~     proteinuria (excessive excretion of protein in the urine). About half of patients with FSGS~     eventually require kidney dialysis or transplant. Steroids, which are currently used to treat~     the disease, are effective in only a minority of patients. Other drugs, such as cyclosporin~     and cyclophosphamide, improve proteinuria in a very small percentage of patients and have~     serious side effects.~      Patients with FSGS who wish to participate in this study will undergo pre-study evaluation~     with blood and urine tests. Patients must be on a stable dose of an ACE inhibitor (a drug~     that lowers blood pressure and reduces proteinuria) for at list 6 months before starting~     pirfenidone therapy. (Patients who are not already taking an ACE inhibitor will be started on~     the drug; those who cannot tolerate ACE inhibitors will be given a different drug.) Patients~     with elevated cholesterol will take a cholesterol-lowering drug. A diet containing~     approximately 1 gram of protein per kilogram of body weight per day will be recommended.~      Patients will take pirfenidone by mouth 3 times a day for 12 months. Blood and urine will be~     tested once a month, either at NIH or by the patient's local kidney specialist. They will~     collect two 24-hour urine samples at the beginning of the treatment period, at 2-month~     intervals throughout the study, and at a 6-month follow-up. Patients will also be asked to~     give three to five tubes of blood and urine samples for analysis during the study.~      In animal studies, pirfenidone improved kidney function and proteinuria and reduced kidney~     scarring in rats with a disease similar to FSGS. In human studies, pirfenidone improved~     breathing and survival in patients with lung fibrosis.~   "
274381|NCT00001958|"~     This 12-month study will evaluate the safety and effectiveness of hydroxyurea in treating~     beta-thalassemia, a type of anemia caused by defective hemoglobin (the oxygen-carrying~     pigment in blood). Hemoglobin is composed of two protein chains-alpha globin chains and beta~     globin chains; patients with beta-thalassemia do not make beta globin. Patients often require~     frequent red blood cell transfusions. This leads to iron overload, which, in turn, requires~     iron chelation therapy (removal of iron from the blood).~      Some drugs, including hydroxyurea, can stimulate production of a third type of protein chain~     called gamma chains. In the womb, the fetus makes this type of protein instead of beta~     globin. It is not until after birth, when the fetus no longer produces gamma globin that the~     beta globin deficiency becomes apparent. Gamma chain synthesis improves hemoglobin and red~     blood cell production, correcting the anemia. This study will determine if and at what dose~     hydroxyurea treatment reduces patients' need for red blood cell transfusions and whether~     certain factors might predict which patients are likely benefit from this treatment.~      Patients 15 years and older with moderately severe beta-thalassemia may be eligible for this~     study. Participants will take hydroxyurea daily at a dose calculated according to the~     patient's body size. Blood will be drawn weekly to measure blood cell and platelet counts.~     The drug dosage may be increased after 12 weeks of treatment and again after 24 weeks if the~     white cell and platelet counts remain stable. Patients who respond dramatically to treatment~     may continue to receive hydroxyurea for up to 3 years.~   "
274387|NCT00001952|"~     The effectiveness of local anesthetics is reduced if inflammation is present, making it~     difficult to control pain during such procedures as root canals and wisdom teeth removal.~     This set of studies will assess the effectiveness of the opioid (synthetic narcotic) fentanyl~     in enhancing the local anesthetic lidocaine (delivered with epinephrine) when used on~     inflamed molar teeth.~      In the first study, a topical anesthetic patch or a placebo will be placed on the gum tissues~     next to four or five lower posterior teeth. The patch will removed at either 5, 10, or 15~     minutes. An electronic test that sends a light electronic impulse into the tooth, lip~     sensitivity testing (Is your lip numb?), and discomfort reports will be started immediately~     after removal of the patch and repeated every 5 minutes for 30 minutes. An oral surgeon will~     then remove the patient's wisdom teeth (tooth).~      In the second and third studies, a topical anesthetic will be placed on the gum tissue. An~     electronic test that sends a light electronic impulse into the tooth, lip sensitivity testing~     (Is your lip numb?), and discomfort reports will be started and done several times~     throughout the test. Then two small openings, one on each side of the tooth, will be drilled~     into the bony tissues surrounding the tooth. A narcotic drug fentanyl or a placebo drug will~     be delivered through these openings, allowing placement of the drug next to the nerves that~     are difficult to numb. Lidocaine, along with a small amount of epinephrine, will be~     delivered. An oral surgeon will then remove the patient's wisdom teeth or tooth (study 2) or~     do a root canal (study 3).~      In the fourth study, a topical anesthetic will be placed on the gum tissue. Then two small~     openings, one on each side of the tooth, will be drilled into the bony tissues surrounding~     the tooth. A narcotic drug fentanyl or a placebo drug will be delivered through these~     openings. Lidocaine, along with a small amount of epinephrine, will be delivered at one of~     three rates (15 patients for each rate). Blood pressure, heart rate, and breathing rate will~     be taken before the topical anesthetic patch is applied, 2 minutes after, and every 5 minutes~     for the next 45 minutes. Blood samples will be taken 6 times over the course of 60 minutes.~     When testing is complete, an oral surgeon will remove the wisdom teeth (tooth). One month~     later, blood samples will be taken using a different drug delivery method in order to compare~     results.~   "
274382|NCT00001957|"~     This study aims to increase our understanding of the difficulty people have recognizing the~     spoken word, especially in noisy situations.~      Subjects must be between 12 and 18 years old with no history of voice disorder, autism,~     stuttering, aphasia, multiple sclerosis, traumatic brain injury, severe language disorders,~     and psychiatric disorders. Group A subjects must show reduced speech-in-noise scores and~     Group B subjects must demonstrate speech-in-noise scores within normal limits.~      The child will perform a series of hearing tasks that will take from 1.5 to 2 hours, with a~     break halfway through. A routine hearing test will be given. The child will sit in a~     sound-treated room wearing earphones and will depress a button in response to sound or to~     repeat words. The words may be in quiet or mixed with noise. In a test called immitance,~     air pressure change and tones will be sent through a miniature probe in the ear for about 1~     minute. TEOAE (transient-evoked otoacoustic emission) testing will test the inner ear with~     clicking sounds. At times, noise will be presented through a probe in the opposite ear.~      The child will listen to a series of recordings of speech in quiet and in noise and will be~     asked to repeat what is heard. These recordings will include monosyllabic words with some~     part of the sounds cut out; words presented with several voices speaking together; two words~     presented at the same time, one to each ear (child must repeat both words); and two sentences~     presented at the same time, one to each ear (child must repeat sentence presented to chosen~     ear).~      The only risk in this study is tiredness from listening.~   "
274383|NCT00001956|"~     The purpose of this study is to learn more about the role of genetics in pain sensitivity.~     Pain perception varies widely among individuals, and information gained from this trial may~     lead to better methods of preventing and controlling pain. The study consists of two parts,~     described below. All enrollees will participate in part 1; patients needing oral surgery for~     removal of third molars may also participate in part 2.~      Normal volunteers, oral surgery patients, and family members of both groups may be eligible~     for this study.~      Part 1 -Sensitivity testing for hot and cold. Participants will rate their pain response to~     hot and cold stimuli on a scale from no pain to the worst pain imaginable. Heat~     sensitivity is measured using a small probe placed on the skin for a few seconds. The hottest~     temperature tested may cause pain for a few seconds but will not produce a burn. Response to~     cold is measured by placing the hand in cold water for up to 3 minutes and occasionally~     flexing the fist. Participants will rate their pain level every 15 seconds. In addition to~     the testing, a blood sample will be drawn to examine for genes related to pain.~      Part 2 - Oral surgery. Patients will have their third molar removed under a local anesthetic~     (lidocaine) injected in the mouth and a sedative (Versed) given through a vein in the arm. A~     small tissue biopsy will be taken from the tissue over one of the third molars. Patients will~     stay in the clinic for up to 7 hours after surgery while the anesthetic wears off and will~     rate any pain they may have according to the rating scale used in Part 1 of the study. Pain~     medication (ketorolac, or Toradol) will be given when needed, and patients will complete pain~     questionnaires for 3 hours after the drug is given to rate its effectiveness. Patients will~     receive additional pain relievers, if needed. A second biopsy on the side opposite the first~     will be taken under local anesthetic to measure changes in chemical signals produced in~     response to the surgery.~   "
274384|NCT00001955|"~     This 2-part study will evaluate the effectiveness and side effects of two anti-inflammatory~     drugs for relieving pain and improving jaw function in patients with temporomandibular~     disorder (TMD). Part 1 will evaluate celecoxib (Celebrex); Part 2 will evaluate etanercept~     (Enbrel). The Food and Drug Administration has approved both of these drugs for treating~     certain forms of arthritis.~      Patients between the ages of 18 and 65 years with painful jaw joint conditions may be~     eligible for this study. Candidates will complete several written questionnaires about their~     jaw condition and will undergo a medical history, complete TMD evaluation, blood and urine~     tests, and imaging studies of the temporomandibular joint, such as X-rays and magnetic~     resonance imaging. Patients will rate the quality and intensity of their pain before~     beginning treatment. At certain periods during the study, they will also keep a pain diary,~     twice a day recording the intensity and magnitude of their pain.~      Part 1 - Celecoxib: Patients will be randomly assigned to receive either 1) celecoxib twice a~     day by mouth; 2) naproxen (a non-steroidal anti-inflammatory drug) twice a day by mouth; or~     3) a placebo (inactive pill) twice a day by mouth.~      Part 2 - Etanercept: Patients will be randomly assigned to receive either 1) etanercept~     injected under the skin or 2) saline (an inactive placebo) injected under the skin. Patients~     in this group will also undergo two aspirations of fluid from the jaw joint - once before~     treatment begins and again 6 weeks later. For this procedure, the joint is numbed with an~     anesthetic and then a needle is inserted into the jaw space to withdraw fluid, which will be~     analyzed for inflammatory processes in the joint.~      All patients will have a final evaluation 6 weeks after beginning treatment, including a TMD~     physical examination, laboratory and X-ray tests as required. The pain diary and~     questionnaires will be collected at this visit.~   "
274385|NCT00001954|"~     This study will test the effectiveness of etanercept (Enbrel) for treating Sjogren's~     syndrome-an autoimmune disease that affects the secreting glands. (In autoimmune diseases,~     the immune system attacks the body's own tissues.) Reduced lacrimal (tear) gland function~     causes dry eyes with a scratchy sensation, and, in severe cases, vision be may impaired.~     Reduced salivary gland function causes dry mouth, resulting in greatly increased tooth decay.~     Dry mouth also makes chewing and swallowing difficult, which may lead to nutrition~     deficiencies. Sjogren's syndrome can also cause dryness of the skin and of mucous membranes~     in the nose, throat, airways, and vagina.~      Patients with Sjogren's syndrome who have had oral and eye examinations under NIDCR's~     protocol 84-D-0056 may participate in this study. Participants will be randomly assigned to~     receive either etanercept or placebo (an inactive look-alike substance) by injection under~     the skin twice a week for 3 months.~      Patients will be seen for evaluation before treatment begins (baseline) and again at 1, 3,~     and 4 months. The baseline and 3-month visits include a physical examination, eye~     examination, saliva collection from salivary glands, blood tests, and evaluation for changes~     in symptoms and treatment side effects. The 1- and 4-month visits include saliva collection,~     blood tests, and review of symptoms and treatment side effects. In addition, blood will be~     drawn every 2 weeks for safety monitoring. Patients will also be surveyed weekly (by~     telephone or during the clinic visit) about symptoms and treatment side effects.~      The Food and Drug Administration has approved Enbrel for treating certain forms of arthritis,~     which, like Sjogren's syndrome, are autoimmune disorders of the connective tissue. Laboratory~     studies also indicate that etanercept may be an effective treatment for Sjogren's syndrome.~   "
274386|NCT00001953|"~     This study aims to learn more about how the immune and hormonal systems function in patients~     with Sjogren's syndrome, a disease in which the immune system does not function properly.~     Adult nonpregnant females are invited to participate. Oral contraceptives may not be taken~     for 6 weeks before and during this study, so another form of birth control must be used, such~     as abstinence.~      There will be two visits. At the first visit, a medical history and physical examination will~     be conducted, and blood and urine tests will be done. The total amount of blood drawn will be~     10 tablespoons. This visit will last 3 hours. At the second visit, participants will have an~     oral glucose tolerance test. To prepare for it, they must be on a special diet for 3 days~     beforehand and keep a diary of eating, sleeping, and physical activities for those 3 days. A~     urine sample will be taken at the beginning of the visit. Subjects must then drink a very~     sweet carbonated cola. A small plastic tube will be placed into an arm vein. Blood will be~     drawn through this tube eight times over 3 hours. The total amount of blood drawn will be 17~     tablespoons.~      Only minor inconveniences are anticipated as a result of participating in this study. Risks~     from blood tests include soreness, bruising, and minor infection at the puncture site, and~     dizziness. The oral glucose tolerance test may cause temporary stomach bloating, headache,~     nausea, and vomiting.~   "
274873|NCT00000448|"~     This study will assess naltrexone's effectiveness in treating alcoholism in women and provide~     information on its potential value in treating eating disorders common among alcoholic women.~     Alcoholic women with and without both eating disorders and depression will be randomly~     assigned to placebo or naltrexone treatment. Each group will receive behavioral therapy for~     12 weeks, with followup 6 months after treatment.~   "
274388|NCT00001951|"~     The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen).~     Currently, androgen is not included in hormone replacement therapy for women with premature~     ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who~     experience ovarian failure at menopause (around the age of 50). However, 1% of women will~     experience premature failure of the ovaries before the age of 40. There have been no studies~     conducted to determine proper hormone replacement therapies for these younger women. Some~     research suggests that the usual menopausal hormone replacement therapy is not adequate to~     protect young women with premature ovarian failure from developing osteoporosis. Women with~     premature ovarian failure have abnormally low levels of androgens circulating in their blood.~     This may contribute to the increase risk for osteoporosis.~      This study will compare two treatment plans for women with premature ovarian failure.~     Treatment plan one will be physiological estrogen hormone replacement. Treatment plan two~     will be physiological estrogen hormone replacement plus androgen. The study will attempt to~     determine which plan is more beneficial to women in relation to osteoporosis and heart~     disease.~      The hormones will be contained in patches and given by placing the patches against the~     patient's skin. The patches were designed to deliver the same amount of hormone as would be~     normally produced by the ovary in young women.~      The success of the treatment will be measured by periodically checking the density of~     patient's bone in the leg (femoral neck bone) . Researchers will take an initial (baseline)~     measurement of bone density before beginning treatment and then once a year, for 3 additional~     years, during treatment. The study will also consider bone density of the spine, bone~     turnover, heart disease risk factors, and psychological state.~   "
274389|NCT00001950|"~     It is commonly believed that objects in the world can be categorized in at least three~     different ways or levels. The three levels are basic, superordinate, and subordinate.~     Previously it was believed that basic categorization presents a cognitive (mental) advantage~     to children's development. However, recent studies on superordinate categorization has~     challenged this belief.~        1. <TAB>Items in superordinate are grouped according to functional purpose, even though~          they may not share any similarities in how they look (perception). For instance, desks,~          chairs, and beds do not appear similar but they can be group together in the~          superordinate category of furniture.~        2. <TAB>Items in basic categorization share similarities in function and in perception. For~          instance, chairs can be considered as a basic category. Chairs can share functional and~          perceptual similarities with many kinds of chairs but are readily distinguished from~          other types of furniture like beds or desks.~        3. <TAB>Subordinate categories are subsets of basic categories. For instance, kitchen~          chairs, desk chairs, and high chairs, are all within the basic category of chairs. Each~          one is very similar in it's function to the others but is definitely discriminable.~      This study was developed to investigate the development of categorization at all three levels~     by using a design in which children between the ages of 1 and 3 years are tested for~     categorization at all three levels with sets of objects from the same domain (such as vehicle~     or fruit). Researchers plan to chart when infants develop categorization at the basic,~     subordinate, and superordinate levels over the two-year period.<TAB>...~   "
274390|NCT00001948|"~     This study will examine and compare the health-related quality of life and degree of symptom~     discomfort in two groups of patients receiving intensive drug therapy for HIV infection. One~     group will receive continuous treatment over the entire 88-week study period; the other will~     have interruptions in therapy over the same time period.~      Patients enrolled in the National Institute of Allergy and Infectious Disease's trial,~     Immunologic and Virologic Studies of Intermittent versus Continuous HAART [highly active~     antiretroviral therapy] in the Treatment of HIV Disease, may participate in this study. At~     periodic intervals for a total of 7 times during the 88-week trial, this companion study will~     require participants in both the interrupted and the continuous therapy groups to complete~     the following two questionnaires:~        1. MOS-HIV Health Survey - The patient provides a self-assessment of his or her physical~          and emotional well being. Survey questions are related to the ability to perform work~          and daily living activities, mood and state of mind, limitations on social activities,~          ability to concentrate, energy level, pain level, general quality of life, etc.~        2. Symptom Distress Scale - The patient rates the degree of symptom distress by ranking~          from 1 to 5 his or her agreement with statements about various physical and emotional~          factors, including appetite, nausea, breathing, cough, pain, insomnia, fatigue, bowel~          problems, concentration, appearance, and outlook.~      Understanding the impact of HIV treatments on health-related quality of life and symptom~     distress may provide information helpful in evaluating new treatment approaches.~   "
274391|NCT00001946|"~     This study will evaluate ways to improve magnetic resonance angiography (MRA) for diagnosing~     atherosclerosis (hardening and narrowing of the arteries).~      MRA is a new method for looking at arteries and veins without standard angiography, which~     requires inserting a catheter into a blood vessel, injecting a contrast material, and~     obtaining X-ray images. Current MRA techniques, however, do not depict the lumen (cavity) of~     small vessels well enough to accurately determine the extent of their narrowing. This study~     will test image processing methods with the eventual goal of improving MRA accuracy to the~     point that it can replace X-ray catheter angiography for diagnosing atherosclerotic disease.~      Patients with atherosclerosis who have had conventional angiography at Suburban Hospital in~     Bethesda, MD, may be considered for this study. They will be screened with a brief history~     and physical examination, and those enrolled will have a MRA scan within 72 hours of their~     conventional angiogram. For this procedure, a catheter is placed in a vein in the patient's~     arm and the patient lies on a table that slides into a magnetic resonance imaging (MRI)~     scanner-a large donut-shaped machine with a magnetic field. Surface coils-flexible, padded~     antennae used to improve the quality of the pictures-are wrapped around the patient's legs.~     At times during the scan, the patient is asked to hold his or her breath for several seconds,~     and a contrast material called gadolinium is injected through the catheter in the vein. This~     substance enhances the images of blood flow in the vessels. The procedure generally takes~     about an hour and a half, although the actual imaging takes only a small part of that time.~   "
274392|NCT00001941|"~     The purpose of the study was to determine: (1) the toxicity and maximum tolerated dose (MTD)~     of humanized anti-Tac (daclizumab), (Zenapax(Registered Trademark)) in patients with adult~     T-cell leukemia/lymphoma (ATL); (2) to define the dose of Zenapax(Registered Trademark)~     required to saturate interleukin 2 receptor alpha (IL-2R) alpha in patients with ATL; (3)~     determine the clinical response to humanized (Hu) anti-Tac (Zenapax(Registered Trademark) of~     patients with Tac-expressing adult T-cell leukemia; and (4) determine the serum dieaway curve~     (pharmacokinetics) of infused humanized (Hu)-anti-Tac in patients who have ATL. This study~     represented an extension of Metabolism Branch National Cancer Institute (NCI) protocols~     utilizing modifications of the original murine anti-Tac monoclonal antibody (mAb) developed~     by our group for the treatment of ATL. The scientific basis for these therapeutic studies is~     that the leukemic cells of patients with ATL express abnormally high levels of the Tac~     antigen (IL-2R alpha) on their surface whereas resting normal cells including normal T-cells~     of the patients do not. One presumed mode of action of Hu-anti-Tac in the treatment of ATL~     involves the interruption of the interaction of interleukin 2 (IL-2) with its growth factor~     receptor. To be effective in this goal we must maintain saturation of the IL-2 receptors~     (IL-2R) with humanized anti-Tac thereby preventing IL-2 mediated proliferation and yielding~     cytokine deprivation and apoptotic cell death of the leukemic cells. Eligible patients with~     ATL were treated with escalating doses of Zenapax(Registered Trademark) between groups in the~     Clinical Center of the National Institutes of Health (NIH). Groups of patients received~     sufficient Zenapax(Registered Trademark) to yield saturation of the IL-2 receptor for a~     period of 17 weeks. Clinical response was evaluated using routine immunological and clinical~     evaluation and by monitoring the saturation of the IL-2R and the absolute number of residual~     circulating malignant cells by fluorescence activated cell sorting (FACS) analysis using two~     fluorochrome-labeled non-crossreacting antibodies to the IL-2 receptor, anti-Tac and 7G7/B6,~     as well as antibodies to cluster of differentiation 3 (CD3), cluster of differentiation 4~     (CD4), cluster of differentiation 7 (CD7), and cluster of differentiation 8 (CD8).~     Furthermore, responses were evaluated in patients with leukemia by Southern blot analysis of~     the arrangement of the T-cell receptor genes and human T-lymphotropic virus type 1 (HTLV-I)~     integration. Finally, in select patients, to define the pharmacokinetics of the therapeutic~     antibody, had planned to monitor the serum levels of the infused Hu-anti-Tac~     (Zenapax(Registered Trademark)) as a function of time. This study is an essential element of~     our program involving IL-2R-directed therapeutic studies. If as anticipated the therapy with~     humanized anti-Tac yields some partial and complete remissions in patients with ATL, we will~     propose that it be used as a single agent for patients with smoldering and chronic ATL and in~     association with chemotherapeutic agents to provide a novel approach for the treatment of~     acute and lymphoma forms of ATL. We also plan a future clinical trial where tentative plans~     also had been made to evaluate the efficacy and toxicity in ATL patients of saturating doses~     of Zenapax(Registered Trademark) as compared to identical doses of Zenapax(Registered~     Trademark) given in association with (90)Y-armed 7G7/B6, a non-competing antibody to IL-2R~     alpha or in combination with chemotherapy.~   "
274401|NCT00000112|"~     The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is~     more than just a cosmetic problem, having substantial metabolic consequences. Insulin~     resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen~     in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance~     in lean children with a family history of diabetes and obese children with acanthosis~     nigricans with or without a family history of diabetes mellitus will be studied.~   "
274878|NCT00000443|"~     The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the~     treatment of alcohol dependent patients; b) investigate whether early versus late onset~     alcoholism predicts treatment outcome; and c) determine whether the early and late onset~     groups respond differently to treatment. Individuals will be typed into early onset and~     late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient~     treatment program.~   "
274393|NCT00001938|"~     Every cell in the human body contains hundreds of thousands of genes and the proteins made by~     the genes. Sometimes changes take place in the genes or proteins that may make the cells more~     likely to develop into cancer. An experimental protein profile test that finds these changes~     may be able to provide information about whose cancer will stay in remission and whose will~     return.~      Volunteer patients whose epithelial ovarian cancer is in remission are eligible for this~     study. Specimens will be collected from blood, saliva, and urine for the first protein~     profile test. Sample sets for more protein profile tests will be collected at follow-up~     visits 1 month and 3 months later and every 3 months afterward. If and when the cancer~     returns, an additional sample set will be obtained and a biopsy of the relapsed tumor will be~     taken both for a protein profile test and for review of the function and structure of the~     disease (pathology review). The protein profiles from these samples will be compared to those~     samples already collected to detect protein pattern changes. The amount of lysophosphatidic~     acid (LPA) in the blood, a sign of ovarian cancer, will also be measured to see if LPA is~     useful in detecting the return of ovarian cancer.~      If patients get fluid in the stomach or chest, it will be tested for cancer cells and~     proteins made by the tumor. If a physical exam or CT scan indicates a possible return of the~     cancer, a biopsy will be performed and a sample saved for a protein profile.~   "
274394|NCT00000433|"~     The Division of Rheumatology at University of California San Francisco is conducting a~     research study on the treatment of ankylosing spondylitis (AS) with a new therapy currently~     used for people with other forms of arthritis. The drug, called Enbrel (or etanercept), is a~     protein that is given twice weekly by injection underneath the skin. It blocks the action of~     tumor necrosis factor-alpha (TNF-alpha), a substance that may be involved in AS, rheumatoid~     arthritis, and other inflammatory conditions. We will randomly assign patients to receive~     either the drug or a placebo (inactive treatment) for 4 months. The results we will monitor~     include morning stiffness, spinal mobility, activities of daily life, and safety of the drug.~   "
274395|NCT00000432|"~     This is a large study of an educational program on Lyme disease prevention for passengers on~     ferry boats going to Nantucket Island during the period from Memorial Day until Labor Day.~     Some boats provide passengers with the experimental program and the other boats provide a~     control program that the researchers can compare to the experimental program. The~     experimental program uses live performances by entertainers to teach people about Lyme~     disease prevention, and also uses additional printed materials. People on the control boats~     receive education on injury prevention and road safety while bicycling, rollerblading, and~     using mopeds. The main result we will look for is Lyme disease identified by a followup~     survey and confirmed by reviewing medical records. We will also ask some people to take part~     in a smaller study of behavior change. In this study, we will ask people to complete forms on~     self-efficacy (a person's belief in his or her ability to reach a certain goal), their plans~     to take preventive steps, and actual prevention behaviors. We also ask participants who~     report doctor visits or illness to provide confirmation of their use of health services.~   "
274396|NCT00000431|"~     Most chronic (long-lasting) wounds of the leg (also known as venous ulcers) fail to heal in a~     reasonable period of time. Although researchers have made great progress in understanding how~     the body repairs wounds, attempts to develop new treatments have been disappointing. In~     general, treatments based on recent findings about the details of wound repair have not~     greatly reduced the number of people who have chronic wounds. The long-term goal of this~     study is to evaluate a new approach for healing a chronic wound. Current methods of directly~     applying substances that are involved in wound healing to a chronic wound do not cause enough~     healing. PDGF-B (platelet-derived growth factor B), a factor associated with wound healing,~     might dramatically enhance healing if a genetically engineered virus is injected into the~     wound that causes cells in the wound to produce PDGF-B in large quantities.~   "
274397|NCT00000430|"~     Osteoporosis, a condition in which bones are fragile and break easily, is a major health~     problem for postmenopausal women. Research studies have shown that both estrogen/progestin~     replacement therapy (hormone replacement therapy, or HRT) and alendronate are effective in~     preventing and treating osteoporosis. However, because these drugs work in somewhat different~     ways, a combination of the two drugs might protect women from osteoporosis better than either~     drug alone. In this study we will test whether HRT and alendronate given together for 3.5~     years to postmenopausal women with low bone mass will have a greater effect on bone than~     either HRT or alendronate given alone. We will also give every participant in this study~     calcium and vitamin D supplements.~   "
274398|NCT00000429|"~     This study looks at the effects of taking calcium pills on bone health in young people with~     juvenile rheumatoid arthritis (JRA). In this 2-year study, children aged 6-18 who have JRA~     will take either a calcium supplement or a matching placebo (inactive or dummy pill)~     containing no calcium. During the study, researchers and patients will not know if a patient~     is taking calcium or placebo. We believe that patients who take calcium supplements will have~     at least a 10 percent greater increase in total body bone mineral density compared to~     patients who take the placebo.~      We will evaluate patients at Children's Hospital Medical Center every 6 months for 2 years.~     During this 2-year period, participants in the study will take one multivitamin containing~     400 IU (international units) of vitamin D and either 1,000 mg of calcium carbonate (Tums~     tablets) by mouth or a matching placebo once a day. We will check patients 6 and 18 months~     after the 2-year treatment period to find out if people in the Tums-treated group maintain~     any increases in bone formation that occurred during the 2-year treatment period.~   "
274399|NCT00000428|"~     This study will compare the effectiveness of combination therapy with the drugs amitriptyline~     and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with~     fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6~     weeks at a time. The study uses a method that combines results from treatment of individual~     patients to assess overall treatment effectiveness and help individual patients and their~     physicians with their treatment decisions. This study will also help compare the results of~     community-based studies (studies involving private doctors) and studies based at clinical~     research centers.~   "
274400|NCT00000427|"~     Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH)~     stimulates the formation of new bone. The purpose of this study is to compare the~     bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men~     with osteoporosis over a two-and-a-half year period.~   "
274402|NCT00000111|"~     The purpose of this study is to see if we can develop a good graft for oral mucosal tissue~     that is like the top of the mouth in a test tube that could be used successfully in humans.~     We have already done this successfully mice. The next step is to take a small piece of tissue~     from a human volunteer and see if we can grow a larger piece of tissue from it outside the~     human body and graft it back into the same person successfully. We expect that this technique~     will work. It has already been tried in patients with burns of the skin who have had similar~     procedures where the skin is grafted back to them. The significance of this research is that~     oral tissue taken from the top of the mouth or palate is in limited supply and leaves the~     patient with a painful and uncomfortable post surgery experience. If we are successful with~     our technique the patient will experience less pain and discomfort from the site that we are~     using to grow our tissue outside the body than if we had taken it from the top of the mouth~     or palate. In addition, by waiting longer periods to grow the patient's cells we can make~     larger pieces of oral tissue than we could have gotten directly from the patient's mouth.~     Patients who will participate in this study will need to require a soft tissue graft from the~     mouth to an area that needs additional attached or keratinized mucosa. This will most likely~     be either in preparation for patients who have or will have dental implants placed. Another~     subset of patients are those who need scar tissue released or the vestibule of their mouth~     (area that turns from the gums to the lip) released.~   "
274403|NCT00000110|"~     The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS)~     to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged~     bout of endurance running and, 2) determine the pattern (time course) of IML replenishment~     following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of~     energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour~     training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat~     diet in 10 endurance trained athletes who will consume both diets in a randomly assigned~     cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance~     exercise, and that replenishment of IML will be impaired by an extremely low-fat diet~     compared to a moderate-fat diet. Results of this pilot study will be used to apply for~     extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary~     fat on the health and performance of individuals performing heavy physical training. It is~     anticipated that this methodology could also be employed in obesity research to delineate,~     longitudinally, the reported cross-sectional relationships among IML stores, insulin~     resistance and obesity.~   "
274404|NCT00000108|"~     The purpose of this research is to find out whether training at different exercise~     intensities reduces the risk of developing cardiovascular disease (CVD) to a different~     extent. Heart attacks and stroke are the leading cause of death in older women. Reduced~     variability of the heart rate and increased dips and swings in blood pressure are risks~     factors that predict the chance of developing CVD as are increased levels of clotting protein~     fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol~     (>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat~     level before you start training and after 15 and 30 weeks of training in the form of walking.~     At the present time the effects of exercise intensity on these factors are not well~     understood. This study will add to the basic understanding of these issues and allow us to~     recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce~     the risk of developing CVD.~   "
274405|NCT00000107|"~     Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial~     natruretic peptide (proANP) which most likely results in chronic dehydration, leading to~     reduced oxygen transport to tissues and shortness of breath with activity. The purpose of~     this study is to characterize adults with cyanotic congenital heart defects with respect to~     their body composition (water and fat-free mass) and resting metabolic rates. The study~     consists of several measures of how much body water, fat and lean tissue a subject has, and~     measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic~     congenital heart disease will be recruited along with healthy noncyanotic control subjects~     matched for age, gender, and body weight.~   "
274406|NCT00000106|"~     Recently a non-toxic system for whole body hyperthermia (WBH) used at the University of~     Wisconsin has been shown to induce soluble tumor necrosis factor-receptor (sTNF-R) I and II~     when patients are heated systemically to 41.8C for 60 minutes. This observation might provide~     a biological basis for the therapeutic application of WBH to rheumatoid diseases, for which~     there is a positive anecdotal clinical experience. Inherent in the hypothesis which is the~     basis for this protocol is the concept that the induction of TNF receptors by WBH may induce~     a remission in patients with active rheumatoid arthritis. Beyond clinical response the~     biological endpoint for this investigation includes cytokine levels, TNF levels, sTNF-R~     levels and changes in cellular TNF receptors.~   "
274407|NCT00000393|"~     To study the safety, toxicology, and activity of Peptide T (D-Ala-1-peptide-T-amide) in~     humans and to find out more about the ability of peptide T to prevent, halt, and/or reverse~     AIDS-associated immunologic disturbances.~      Recent information suggests that the central nervous system (CNS) is often impaired in~     HIV-infected individuals. The dysfunction of the CNS may be either a direct or an indirect~     result of HIV infection. One method to prevent HIV infection is to block entry of the virus~     into the cells of the body. Peptide T shows laboratory evidence of blocking the entrance of~     HIV into cells that are susceptible to HIV infection. Studies that have been done indicate~     that peptide T is nontoxic in the doses that are used in this study.~      AIDS patients with minimal (group 1) or moderate (group 2) cognitive dysfunction (mental~     impairment) receive an increasing schedule of three dosage levels of peptide T. All patients~     receive an intravenous (IV) dose of peptide T for 10 days followed by the intermediate dose~     and then the highest dose, each intravenously for 10 days. Following successful completion of~     3 IV doses, four patients participate in an intranasal pharmacokinetic (blood level study)~     dosage trial of 3 doses (different from IV) of peptide T once for each of 3 successive days.~     Follow-up continues for up to 1 year.~   "
274879|NCT00000442|"~     This study is to evaluate the safety and effectiveness of an injectable slow releasing~     preparation of naltrexone to reduce alcohol consumption and risk of relapse in~     alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection~     for a total of three months, with two subsequent followup visits spanning a 6- month period.~   "
274409|NCT00000391|"~     To study the safety and toxicity of intranasal peptide T (D-Ala-1-peptide-T-amide) in humans,~     and to find out how quickly and how much of a given dose enters the bloodstream and how~     quickly it leaves the bloodstream. To obtain information on the ability of intranasal peptide~     T to prevent, halt, and/or reverse the effects of AIDS on the central nervous system.~      Studies have shown that AIDS is caused by a retrovirus. This virus works by inactivating or~     destroying human CD4 cells (which are part of the human immune system). This in turn leads to~     the observed immunologic defects and related illnesses, including HIV encephalopathy (disease~     of the brain). One method of preventing AIDS is to prevent HIV from entering the cell. HIV~     binds to the receptor CD4 site. Peptide T also binds to this site, and thus by competing for~     that site, can block the binding of the virus to its receptor. Preliminary animal and human~     studies indicate that peptide T is safe at the doses selected for this trial.~      Thirty patients with AIDS or AIDS related complex (ARC) are entered into the study to receive~     an increasing schedule of three dosage levels of intranasal peptide T for 12 - 16 weeks~     followed by a 1-month off-drug follow-up period and a subsequent 1-month return to the drug.~     All patients receive an initial intravenous test dose of peptide T. The test dose is~     administered over 1 hour, followed by an observation period of 8 hours in the outpatient~     clinic.~   "
274410|NCT00000390|"~     To test the effectiveness treating AIDS related depression with imipramine hydrochloride.~      Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due~     to the relentless course of HIV infection, there is a certain reluctance to treat the~     associated depression. In other illness, it has been proven that treating the depression~     often results in improvement of overall health status.~      This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride~     every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating~     Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over~     phase in which placebo non responders are entered into an open-label study and given~     imipramine hydrochloride.~   "
274411|NCT00001936|"~     The purpose of this study is to determine the feasibility of using extrinsic laryngeal muscle~     stimulation to elevate the larynx in a manner similar to that which occurs during normal~     swallowing. This research will also determine whether laryngeal elevation will open the upper~     esophageal sphincter to assist with entry of the bolus into the esophagus. This protocol~     includes studies in normal volunteers and patients with swallowing disorders. The outcome of~     this study will be relevant to future use of neuromuscular stimulation for laryngeal~     elevation in patients with pharyngeal dysphagia....~   "
274412|NCT00001934|"~     This study will examine the safety and effectiveness of Zenapax (a laboratory-manufactured~     antibody) in treating multiple sclerosis. Multiple sclerosis may be caused by an abnormal~     immune response in which white blood cells called T lymphocytes attack the myelin sheath that~     covers nerves and parts of the spinal cord. Zenapax binds to protein receptors on~     lymphocytes, keeping them from interacting with interleukin-2, a substance necessary for~     their growth.~      Patients with multiple sclerosis who have had at least one relapse within 18 months of the~     start of the study and in whom interferon-beta treatment has not been successful may be~     considered for this study. There are two study phases: baseline and treatment. During the~     baseline phase, patients will have three magnetic resonance imaging (MRI) scans over 2 months~     to evaluate their disease activity. During treatment, patients will receive seven intravenous~     (I.V.) infusions of Zenapax in the clinic. The first two infusions will be given 2 weeks~     apart; the next five will be given once a month.~      Patients will have MRI scans before each infusion. The MRIs will be done using the standard~     procedure and again using a contrast agent, gadolinium, injected into a vein. Gadolinium~     helps identify new multiple sclerosis lesions in the brain. Blood and urine samples will be~     taken during each clinic visit. In addition, patients will have skin tests, similar to a~     tuberculin test, to evaluate immune status, and will be asked to undergo two lumbar punctures~     (spinal tap; these will be optional)-one before the treatment phase begins, and another when~     treatment is completed. Lymphocytes will also be collected from patients before, during and~     after treatment. The lymphocytes are obtained by a procedure called apheresis: about a pint~     of whole blood is drawn through a needle in the arm, the lymphocytes are separated out and~     removed by a machine, and the rest of the blood is returned through a needle in the other~     arm. These studies will hopefully allow conclusions about the safety of Zenapax in MS, but~     also address its effectiveness with respect to modifying the inflammatory activity in the~     brain of MS patients and inhibit autoimmune T lymphocytes that are involved in the disease~     process.~   "
274413|NCT00001933|"~     Some of the thinking difficulties of Alzheimer's patients may be due to a deficiency in a~     brain chemical called acetylcholine, which helps transmit messages between nerve cells.~     Nefiracetam is a new drug that stimulates acetylcholine. This study will test whether~     Nefiracetam can safely improve memory, thinking and activities of daily living in patients~     with mild to moderate intellectual impairment due to Alzheimer's disease.~      Patients in the study must have a caregiver and designated representative. Candidates will be~     given a medical history and physical examination that includes a complete neurologic and~     neuropsychologic evaluation, blood tests, and an electrocardiogram. A chest X ray and~     magnetic resonance imaging (MRI) test will be done on patients who have not had these tests~     within the previous two years. During the 20-week study, each patient will take three pills~     twice a day for twenty weeks of either Nefiracetame or placebo (sugar pill). Neither the~     patients nor the doctors will know which patients are getting the drug and which are getting~     the placebo. Blood and urine tests will be done frequently throughout the study. Patients~     will be asked to have a spinal tap (on a voluntary basis) to measure the levels of drug in~     the spinal fluid, and a PET scan (a brain imaging test).~      At the end of the study, patients who feel they are doing well with no side effects from the~     drug (or placebo) may be given the option of continuing treatment for another seven months.~      Animal studies showed that Nefiracetam improved learning impairment and memory in rats with~     dementia. In a small study of humans, about one-fourth of patients who were given a low dose~     of the drug had improved intellectual function, and about one-half who received a higher dose~     improved.~   "
274414|NCT00001932|"~     Patients in this study will undergo PET scans (a type of nuclear imaging test) to look for~     abnormalities in certain brain proteins associated with seizures.~      Studies in animals have shown that serotonin-a chemical messenger produced by the~     body-attaches to proteins on brain cells called 5HT1A receptors and changes them in some way~     that may help control seizures. There is little information on these changes, however. A new~     compound that is highly sensitive to 5HT1A, will be used in PET imaging to measure the level~     of activity of these receptors and try to detect abnormalities. Changes in receptor activity~     may help determine where in the brain the seizures are originating.~      Additional PET scans will be done to measure the amount of blood flow to the brain and the~     rate at which the brain uses glucose-a sugar that is the brain's main fuel. Blood flow~     measurement is used to calculate the distribution of serotonin receptors, and glucose use~     helps determine how seizures affect brain function.~      The information gained from the study will be used to try to help guide the patient's therapy~     and determine if surgery might be beneficial in controlling the patient's seizures.~   "
274415|NCT00001927|"~     Effective treatment and prevention strategies for childhood stroke and porencephaly can only~     be developed once the causes are understood. There is increasing evidence that inherited and~     acquired coagulation abnormalities alone or in combination with environmental factors,~     predispose to arterial and venous thrombosis. Inherited abnormalities of factor V Leiden,~     prothrombin, protein C, protein S, and antithrombin III may account for many of these~     thromboses. At present there is little information on the existing distribution of these~     coagulation anomalies in children with thrombosis. Recent reports also suggest that these~     clotting abnormalities may be responsible for some instances of intracranial hemorrhage,~     porencephaly, cerebral palsy and fetal death.~      This study will measure the frequency of several coagulation factor abnormalities (factor V~     Leiden, prothrombin 20210A, protein C, protein S, antithrombin III, and antiphospholipid~     antibodies) in children with a history of porencephaly and stroke, and will compare these to~     the prevalence of these mutations in population controls and family members. We will also~     describe the exogenous conditions which in concert with these coagulation factors, may have~     led to the development of thrombosis in these children....~   "
274416|NCT00001926|"~     The purpose of this study is to test the belief that specific areas of the brain are~     connected differently in blind patients than patients with sight. In addition, the study will~     examine the different anatomical connections between brain areas of patients who became blind~     early in life versus patients who became blind later.~   "
274417|NCT00001925|"~     Tremors are involuntary movements of a part or parts of the body that occur because of~     alternating contraction and relaxation of muscles. The causes behind most tremors are poorly~     understood.~      Some studies suggest tremors could be caused by abnormalities in a particular area of the~     brain called the olivary nucleus. Researchers believe that the cells making up the olivary~     nucleus may be responsible for generating a central rhythm of the body and may therefore also~     be responsible for the generation of tremors.~      Consumption of alcohol has been known to reduce tremors in some patients. Researchers believe~     that the alcohol may work directly on the cells of the olivary nucleus. As a result,~     researchers would like to determine the effects of alcohol on three different kinds of~     tremors (physiological, symptomatic palatal, and essential palatal).~   "
274418|NCT00001923|"~     Phantom pain refers to the sensation of pain felt by patients who have had a limb amputated.~     The treatment of phantom pain is often disappointing and is unable to provide adequate relief~     to the patients. The area of the brain involved (posterior parietal cortex [PPC]) is found on~     the opposite side of the amputated limb. For example, if a patient has the right arm~     amputated, the left posterior parietal cortex is involved in the phantom pain.~      Researchers believe that if they can decrease activity in the posterior parietal cortex they~     may be able to reduce phantom pain.~      Researchers plan to use low frequency (1 Hz) transcranial magnetic stimulation (TMS) to~     decrease the excitability of the PPC opposite the side of the amputated limb. TMS involves~     the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp and~     turning on the magnetic flux. This permits non-invasive, relatively localized stimulation of~     the surface of the brain (cerebral cortex). When an area of the brain is stimulated a period~     follows when that area cannot be stimulated again. In this case, researchers plan to use TMS~     to stimulate the PPC in order to decrease the level of excitability there.~   "
274419|NCT00001922|"~     This research study is designed to improve understanding about voice disorders that are due~     to uncontrolled muscle contractions affecting the voice box. The type of voice disorder~     depends on which muscles of the voice box are involved. Abductor spasmodic dysphonia may lead~     to a weak voice. Adductor spasmodic dysphonia may result in a strangled voice. Muscular~     tension dysphonia may lead to a strained voice. Some of the major goals of the study are to;~        1. understand how sensation from the voice box affects voice and speech production~        2. develop better ways to diagnose sensation abnormalities affecting the voice box~        3. determine if patients with voice disorders differ from persons without voice disorders~          in the way they respond to sensory information from their voice box~      Researchers believe that by understanding better how sensations of the voice box are~     presented and how the muscles in the larynx respond to those sensations they will be able to~     develop better treatments for patients suffering from voice disorders. ...~   "
274420|NCT00001921|"~     This study will explore how the brain works during memory testing in an effort to understand~     why some patients with schizophrenia have memory difficulties.~      Patients with schizophrenia and their unaffected family members are eligible for this study.~     Studying family members may help identify the genes related to the memory deficit in~     schizophrenia. Normal volunteers will also be studied.~      Normal volunteers, patients with schizophrenia, and their family members interested in~     participating in this study will be screened with a complete medical examination and~     psychiatric assessment, and performance of simple tasks. Study participants will be shown~     numbers on a screen and asked to recall them after a brief period. This will be done during~     electroencephalographic (EEG) recording, in which electrodes attached to the scalp measure~     the brain s electrical activity. The same test will be repeated while the patient has~     magnetic resonance imaging of the brain. The combined MRI and EEG testing will permit better~     localization of the brain s electrical activity.~   "
274421|NCT00001920|"~     The purpose of this study is to explore how the brain works during particular memory tasks in~     people with schizophrenia and healthy volunteers.~      Research has shown that patients with schizophrenia have structural and functional~     abnormalities in the hippocampus and cerebellum of their brains. These abnormalities are~     likely associated with the memory impairment experienced by these patients. Eye blink tests~     can provide information about memory acquisition involving the cerebellar and hippocampal~     regions. By altering the stimuli interval, these tests can distinguish between~     cerebellum-dependent memory associated with subliminal mnemonic encoding and~     hippocampus-dependent memory associated with conscious awareness. This study will use~     eyeblink tests to determine which type of memory is predominantly affected in schizophrenia.~      Participants in this study will be screened with a physical and psychiatric examination.~     Participants will have an electroencephalogram (EEG), an electrocardiogram (ECG), and an~     electrodermal test. Evoked potentials and magnetic resonance imaging (MRI) scans of the brain~     may also be taken.~   "
275025|NCT00000518|"~     To determine whether electrophysiologic study (EPS) or Holter monitoring (HM) was the better~     method for selecting effective long-term antiarrhythmic drug therapy in patients with~     sustained ventricular tachycardia, ventricular fibrillation, or an episode of aborted sudden~     death.~   "
274422|NCT00001919|"~     St. John's Wort is a popular dietary supplement that many people take to elevate mood or~     relieve stress. This study will test in normal volunteers whether this preparation may alter~     mood and if so, by what means. Animal studies suggest that St. John's Wort may work similarly~     to some antidepressants that affect levels of the chemical serotonin in the brain.~      Participants in this study must also be enrolled in NIMH protocol #98-M-0094 (SPECT Imaging~     of Dopamine and Serotonin Transporters in Neuropsychiatric Patients and Normal Volunteers)~     and protocol #91-M-014 (MRI Imaging of Neuropsychiatric Patients and Controls). Separate~     consent forms are required for each study. Candidates will undergo medical and psychiatric~     evaluations that may include blood and urine tests, electroencephalogram and~     electrocardiogram.~      Normal volunteers will have a mood assessment at the beginning of the study. They will then~     be randomly assigned to take either placebo (a pill with no active ingredient) or St. John's~     Wort 3 times a day for 2 weeks, and will be told what they are taking. After an 11-week~     hiatus, they will again start treatment on the same schedule, but will not be told which~     preparation they are receiving. Each evening during the 2-week treatment periods, subjects~     will complete a brief self-rating mood assessment questionnaire. At the end of each treatment~     period, they will undergo SPECT brain imaging (a type of CT scan) to determine dopamine and~     serotonin distribution and density in the brain.~      For this procedure, study subjects take three drops of potassium iodide solution within 24~     hours before the scan and two drops nightly for 3 days following the procedure. About 10 ml~     (less than two teaspoons) of blood are drawn before a radioactive tracer is injected. SPECT~     imaging is done the next day. After about 1 hour of imaging, subjects are given either a~     placebo or St. John's Wort, and then imaging continues for another 2 hours. During the~     procedure, up to five blood samples of 6 ml each may be drawn. At some point during the~     study, a MRI scan of the brain will be done.~   "
274423|NCT00001917|"~     The purpose of this study is to use brain imaging technology to study the effects of aging~     and Alzheimer's Disease (AD) on a specific type of brain receptor.~      The brain is made up of cells called neurons. The neurons communicate with one another and~     secrete chemicals called neurotransmitters. The neurotransmitters bind to specific sites on~     other neurons called receptors. Acetylcholine (ACh) is a neurotransmitter that binds to ACh~     receptors. In both aging and AD, the number of neurons that secrete ACh decreases and the~     function of some ACh receptors changes. This study will use positron emission tomography~     (PET) scans of the brain to study the effects of age and AD on muscarinic type 2 [M2], a type~     of ACh receptor.~      Participants in this study will be injected with a radioactive tracer (ligand [F-18] FP-TZTP)~     which binds to [M2] receptors. Participants will then undergo a PET scan in order for the~     density and function of [M2] receptors to be studied.~   "
274424|NCT00001915|"~     Attention deficit/hyperactivity disorder is a condition characterized by a decreased~     attention span, hyperactivity, and/or impulsiveness inappropriate for a certain age.~      Typically, young children have what are known as subtle neurological signs. These are~     involuntary movements of one part of the body that occur while the child is making a~     voluntary movement of another part of the body. This is referred to as synkinesis, or~     overflow movements. These overflow movements disappear during normal development and are~     usually gone by the age of 10. However, in children with ADHD these overflow movements tend~     to be more intense and last long after the age of 10. This leads researchers to believe there~     is an abnormality in the maturation and development of the brain areas associated with motor~     activity in children with ADHD.~      Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that gives information~     about brain function. It is very useful when studying areas of the nervous system related to~     motor activity (motor cortex, corticospinal tract, and corpus callosum). A magnetic signal~     given from a special instrument held close to the patient's head stimulates a small area of~     the brain that controls a few muscles (for example, the muscles that control one finger).~     Doctors put electrodes (small pieces of metal taped to areas of the body) over the muscle to~     measure the electrical activity the muscle produces when it makes a movement. When the~     magnetic signal activates those muscles the electrodes pick up and record the electrical~     activity of the movement that the muscles make in response to the magnetic signal.~      Researchers will study normal children and those diagnosed with ADHD using TMS to find out if~     the clinical abnormalities of ADHD are associated with a delay or abnormality in maturation~     of areas of the nervous system responsible for motor activity (motor cortex and corticospinal~     tract).~   "
274425|NCT00001913|"~     This study uses functional magnetic resonance imaging (fMRI) to look at brain activity while~     patients view pictures of people's faces that they are familiar with or have emotional~     attachment to.~      The functional MRI (fMRI) procedure allows researchers to see the brain at work. It uses~     the same powerful magnetic fields and weak electromagnetic radiation (radiowaves) as standard~     structural MRI. However, functional MRI can also show areas of increased blood flow, which~     relates to increased activity by brain cells.~      This research study builds on previous studies that identified specific areas of the brain~     that are activated by visual stimuli showing faces. However, previous research used anonymous~     faces as stimuli. This study will use faces of individuals known to the patient.~      There are three experiments that will be conducted in the study;~        1. Experiment 1 will attempt to determine the effects of familiarity of the photographed~          face on brain activity patterns. Patients will view familiar faces, the faces of close~          friends and relatives, and the faces of famous people.~        2. Experiment 2 will look at how maternal attachment affects the response to visual~          stimuli. Mothers will view pictures of their first born child, as well as those of~          familiar children to whom they are not related, unfamiliar children, and unfamiliar~          adults.~        3. Experiment 3 will explore the effects of interpersonal attachment and loss on response~          to visual stimuli. In this experiment, bereaved spouses will view pictures of their~          deceased spouse, those of living family members, and those of unfamiliar people.~   "
274426|NCT00001912|"~     This study will examine what causes seizures in patients with cysticercosis (pork tapeworm~     infection). A better understanding of this could lead to improved methods of controlling or~     preventing seizures.~      In humans, the pork tapeworm (Taenia solium) lives in the small intestine. The parasite's~     microscopic eggs travel around the body-including to the brain-where they develop into cysts.~     Usually, the cysts don't cause symptoms until they die. Then, they provoke an inflammatory~     reaction that irritates the brain, causing seizures and other symptoms. The inflammation~     eventually goes away, but the dead cysts remain. Calcium deposits often form where the cysts~     are. Some of the calcified cysts develop swelling around them that seem to be associated with~     the development of seizures.~      This study will explore how and why these dead, calcified cysts continue to cause seizures.~     In so doing, it will try to determine: 1) the best diagnostic imaging method for detecting~     swelling around the cysts; 2) how often swelling occurs; and 3) what makes some cysts prone~     to swelling and related seizure activity, while others are not.~      Patients with cysticercosis who have had seizures or who have known or possible swelling~     around calcified cysts will be studied with various tests, including magnetic resonance~     imaging (MRI), computed tomography (CT) scans, electroencephalography (EEG), blood tests, and~     possibly lumbar puncture. Patients will be studied for two cycles of seizures (during active~     and quiet periods) or a maximum 4 years.~   "
274874|NCT00000447|"~     This study will develop a behavioral and drug relapse prevention program for individuals who~     are dependent on both alcohol and tobacco. The study's goal is to show that individuals~     receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have~     higher rates of abstinence from both smoking and drinking than individuals who do not receive~     the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with~     followup assessments 1, 3, and 6 months after treatment.~   "
274427|NCT00001911|"~     This study will test the safety and effectiveness of a drug called interleukin-12 (IL-12) in~     fighting severe infectious (other than tuberculosis) caused by a group of bacteria called~     mycobacteria. IL-12 is similar to a substance the body produces naturally to strengthen~     immune function (infection-fighting ability). It works by stimulating white blood cells to~     increase production of a chemical called interferon gamma, which can improve or cure~     mycobacterial infections in some patients.~      In previous studies, IL-12 has improved immune function against mycobacteria in test tube~     experiments and in mice. A recent study of three patients with mycobacterial infections~     treated with the drug showed encouraging results. The drug has also been studied more~     extensively in patients with cancer, HIV infection and hepatitis C.~      Patients in this study will receive IL-12 injections under the skin twice a week for one~     year. They will be taught how to self-administer the drug, but a home care nurse or a~     physician may also give the injections. The drug dosage will be increased each week to~     determine the safest and most effective dose for fighting this infection. If intolerable side~     effects develop at a certain dose, the previous dose level will be used for the next~     injection. That dose will then be used for the rest of the study, unless unacceptable side~     effects develop at that level, in which case the dose will again be lowered. Patients will~     receive an antibiotic against mycobacteria.~      Physical examinations and blood and urine tests will be done once a month for at least the~     first year and then every 3 months the following year to evaluate kidney, liver, and immune~     function. The first evaluation-at the start of the study-is done on an inpatient basis.~   "
274428|NCT00001910|"~     This study will examine how allergen immunotherapy (allergy shots) works to reduce or prevent~     reactions to allergens such as pollen, dust or cat dander. Certain T cells (types of white~     blood cells) called Th2 cells produce substances that generate allergies. Other T cells~     called Th1 cells produce substances that have opposite effects. This study will determine if~     allergy shots change the immune response to allergens by reducing the number of Th2 cells or~     by changing them into Th1 cells. A better understanding of how this treatment works may help~     scientists develop more effective allergy therapies.~      People between 18 and 50 years of age who have had allergic asthma for at least 1 year may~     participate in this study. Candidates' medical, allergy and medication histories will be~     reviewed, and they will have a physical examination, including routine blood tests,~     urinalysis, electrocardiogram (EKG), and lung function test. Blood will also be drawn to test~     T cell response to allergens, and 12 skin tests (similar to a tuberculosis skin test) will be~     done to test for sensitivity to various allergens.~      Participants will be admitted to the Clinical Center for 1 to 2 days for rush therapy (see~     below). They will have a brief history and physical examination. A heparin lock (thin plastic~     tube similar to an intravenous line) will be placed in an arm vein. They will then undergo~     the following procedures:~        -  Rush/Cluster Immunotherapy - An allergen is given in increasing doses over 2 to 5 weeks.~          During rush therapy, the dose is increased rapidly over 1 to 2 days until a moderate~          level dose is reached. To reduce the chance of an allergic reaction, patients take~          prednisone, cetirizine (Zyrtec® (Registered Trademark)), ranitidine (Zantac® (Registered~          Trademark)) and montelukast (Singular® (Registered Trademark)) starting 24 hours before~          treatment begins until rush therapy ends. After discharge on the third day, patients~          return to the clinic once a week for the next 2 to 5 weeks for cluster therapy, in which~          the dose is increased more gradually to a maintenance level.~        -  Maintenance Immunotherapy - Participants receive 12 weekly injections at the maintenance~          dose. Blood is drawn during one visit between weeks 2 and 7 of maintenance therapy.~        -  Follow-up Visits - Patients return to the clinic 2 and 3 weeks after the last~          maintenance dose for blood draws and evaluations. In addition, a late-phase allergen~          skin test is done at the 3-week follow-up to compare reaction results with those from~          the test done at the screening visit.~        -  End-of-Study Visit - 12 to 16 weeks after the last allergy shot, patients return for a~          final blood draw and brief evaluation.~   "
274429|NCT00001905|"~     This study will evaluate the safety and effectiveness of the drug, interferon gamma, in~     treating leukocyte adhesion deficiency type I (LAD I). Patients with this inherited immune~     disorder do not have enough proteins called adhesion molecules on their infection-fighting~     white blood cells, impairing the ability of these cells to get to the site of infection. As a~     result, patients have recurrent infections of soft tissues, such as the skin, gums and~     gastrointestinal tract, and poor wound healing. Infants with severe LAD I often die from~     multiple infections. Interferon gamma may increase the number of adhesion molecules on white~     blood cells, and thus improve their function.~      Patients with LAD I who weigh more than 13 kilograms (28.5 pounds) may be eligible for this~     study. Candidates will have personal and family medical histories taken, a physical~     examination, blood and urine tests and a chest X-ray or computed tomography (CT) scan.~      Participants will receive injections of interferon gamma under the skin 3 times a week for 3~     months. Adult patients will be taught how to give their own injections (similar to insulin~     injections for diabetes) and parents will be taught how to administer the shots to their~     child. Blood samples, usually be between 30 to 90 milliliters (2 to 6 tablespoons), will be~     drawn just before starting medication and again 1 day, 1 week, 1 month, 3 months and 4 months~     after therapy begins. At these same time intervals, patients will provide a salt-water mouth~     rinse specimen, which will be tested for changes in the number of white blood cells during~     interferon gamma treatment.~      Patients will be admitted to the NIH Clinical Center for inpatient evaluations at the start~     of therapy and again after 1 week, 1month, 3 months and 4 months. The initial screening visit~     will take a few days and subsequent visits will take 1 to 2 days.~   "
274430|NCT00001901|"~     This study will examine the use of etanercept (also called Enbrel or TNFR:Fc) in patients~     with Wegener's granulomatosis, a type of vasculitis (blood vessel inflammation). Wegener's~     granulomatosis may affect many parts of the body, including the brain, nerves, eyes, sinuses,~     lungs, kidneys, intestinal tract, skin, joints, heart, and other sites. Generally, the~     greater the disease involvement, the more life-threatening it is. Standard treatment is a~     combination of prednisone and a cytotoxic agent-usually cyclophosphamide or methotrexate.~     However, many patients treated with this regimen have a disease relapse, and others cannot~     take these drugs because of severe side effects. This study will evaluate etanercept's safety~     and effectiveness, and particularly its value in reducing the need for prednisone and~     preventing disease relapse.~      The Food and Drug Administration has approved etanercept for treating rheumatoid arthritis,~     another inflammatory disease. The drug works by blocking the activity of TNF-a protein made~     by white blood cells that is involved in the inflammatory process. Since prednisone also~     affects inflammatory proteins and lowers TNF production, the use of etanercept may reduce the~     need for prednisone in patients with Wegener's granulomatosis, and thus the risk of its side~     effects.~      Patients between 10 and 70 years of age with Wegener's granulomatosis who have never taken~     prednisone, methotrexate or cyclophosphamide, or have taken these drugs for less than 3 weeks~     may be eligible for this study.~      Participants will have a medical history review and physical examination, including~     laboratory studies. If medically indicated, X-rays, consultations and biopsies (surgical~     removal of a small tissue sample) of affected organs will also be done. All patients will~     begin treatment with prednisone, methotrexate and etanercept. Those who improve on this~     regimen will stop prednisone gradually over 3 months. Those who achieve disease remission at~     the end of another 3 months will be randomly assigned to either continue taking etanercept~     and methotrexate for another 12 months or to stop etanercept and continue only methotrexate~     for the next 12 months (after which methotrexate will gradually be stopped). Patients who are~     not in remission by the 6-month point will continue taking etanercept until they go into~     remission, when they will be assigned to stop or not stop etanercept, as described above.~     Patients who do not achieve remission within 12 months of beginning treatment will be taken~     off the study. Patients who have a disease relapse while on the study will likely be switched~     to treatment with prednisone and either methotrexate or cyclophosphamide. Patients randomized~     to stop etanercept and who have a relapse within a year of stopping the drug may be offered~     re-treatment on this protocol, but with continuing etanercept for a full year after~     remission.~      Patients will be evaluated in the outpatient clinic every 2 to 4 weeks for the first 4 months~     and every 1 to 3 months after that. Patients whose disease is in remission and who stop all~     medications will be followed every 3 to 6 months for 2 years. Follow-up evaluations include a~     physical examination, blood draws and, if medically indicated, X-rays. The total study~     duration is 60 to 70 months.~   "
274436|NCT00001888|"~     Fiberoptic bronchoscopy is a procedure which involves passing a pencil-thin tube into the~     lung in order to collect fluid and cells from the airways. Fiberoptic bronchoscopy can~     collect cells from the walls of airways by gently brushing them (bronchial brushing). In~     addition, squirting small amounts of sterile water in to the airway and gently suctioning it~     back into the bronchoscope (bronchoalveolar lavage) collects cells.~      In this study, researchers plan to perform these tests on patients with asthma and normal~     volunteers. This research may help to improve the understanding of the processes involved in~     airway inflammation and asthma.~   "
274431|NCT00001899|"~     This study will examine the effects of increases in HIV blood levels on the immune system. A~     better understanding of how HIV alters the immune response may lead to development of~     effective immune-based therapies against the virus.~      Patients 18 years of age or older with HIV-1 infection who have been receiving highly active~     antiretroviral therapy (HAART) may be eligible for this study. In order to study the effect~     of increased levels of virus on the immune system, therapy will be stopped in these patients~     temporarily. Therefore, only patients who have an appropriate level of understanding of the~     potential benefits of therapy and the risks of stopping treatment will be considered for~     enrollment. Pregnant women may not participate and women of childbearing potential must agree~     not to become pregnant during the study. Candidates will be screened with a medical history,~     physical exam, blood and urine tests and possibly a chest X-ray and electrocardiogram.~      Upon entering the study, participants will have blood tests to measure the amount of virus in~     the blood, CD4+ T cell counts, side effects of the medications, and how the patient s immune~     system responds to HIV in the test tube. White cells will be collected through leukapheresis.~     In this procedure, a needle is placed in an arm vein and blood flows from the vein through a~     tube (catheter) into a cell separator machine, where the white cells are separated from the~     rest of the blood by a spinning process. Some of the white cells are collected by the~     machine, and the rest of the blood is returned to the body through a second needle placed in~     the other arm. Patients will then have a physical examination and blood tests every 1 to 2~     weeks and will be managed according to their viral load and CD4 cell counts as follows:~      Viral Load~        -  If viral blood levels remain less than 5000 copies per milliliter, no medical~          intervention is planned.~        -  If viral blood levels rise to 5,000 copies per ml or higher, patients will undergo a~          second leukapheresis and re-start antiretroviral therapy. They will be monitored at~          least monthly until viral load returns to pre-study levels.~      CD4 Count~        -  If the CD4 count rises or remains at pre-study levels, no intervention is planned.~        -  If the CD4 count decreases by 10 to 25 percent of pre-study levels, the counts will be~          monitored every 2 weeks at least 3 times and then monthly.~        -  If the CD4 count decreases by 25 percent or more of pre-study values, antiretroviral~          therapy will be re-started and counts will be monitored until they return to pre-study~          levels.~      If viral and CD4 levels do not return to pre-study levels promptly, patients will continue to~     be monitored and will be advised about possible treatment changes. Alternatively, patients~     whose viral and CD4 levels are similar to or better than pre-study values may be offered~     laboratory testing every 3 months for at least 1 year if there is a scientific reason to~     continue studying the patient s immune system. Patients may be asked to undergo additional~     leukapheresis in the future, or another interruption of therapy in the future if it is felt~     safe to do so.~   "
274432|NCT00001898|"~     This study will look at genetic changes which occur in the development of male and female~     breast cancer and other cancer. It will use a new technology called DNA microarray~     hybridization that looks at a wide array of genes to identify disease-associated patterns in~     the human genome (complete set of human genes). Numerous studies have linked particular genes~     to a given disease, but there is very little information on patterns of gene expression~     (production of proteins from genetic coding) in the entire human genome.~      Pinpointing genetic abnormalities in disease may help classify different forms of cancer and~     perhaps lead to new avenues of treatment or prevention. A primary goal of this study will be~     to create a database of gene expression for human cancers and other disorders that will~     provide the basis for finding genetic abnormalities in disease.~      Tumors specimens used in this study will be taken from tissues biopsied from patients with~     breast, colon cancer, sarcomas or melanoma as part of their routine care. Patients in the~     study will be among those receiving care at the: Department of Oncology, University Hospital,~     University of Lund, Sweden (breast cancer); Department of Medicine, University of Michigan,~     Ann Arbor, Michigan (breast cancer); Surgery Branch, National Cancer Institute, Bethesda,~     Maryland (melanoma), Johns Hopkins Univ. (colon cancer), Memorial Sloan Kettering (sarcoma).~      Patients in the study will have a family history taken and will complete a questionnaire.~     Some patients will be asked to have a blood test. Breast cancer patients will have a~     mammogram if one has not been done within the last year.~   "
274433|NCT00001895|"~     Patients with narrowed heart arteries who undergo coronary angiography (imaging of the~     heart's blood vessels) may participate in this heart mapping study designed to gain~     information about the condition of different areas of the heart muscle.~      In coronary angiography, a thin tube called a catheter is inserted through a small incision~     in the groin and pushed up to the heart. There, a contrast dye is injected, revealing areas~     of blockage in the coronary arteries-the vessels that supply blood to the heart muscle. As~     soon as the angiography is completed, patients in this study will undergo another procedure~     called Biosense mapping. For this procedure, a special catheter with a tiny sensor at the~     tip will be inserted into the sheath that was used for the angiography and advanced to the~     heart's main pumping chamber-the left ventricle. The sensor detects the pattern of an~     electromagnetic field generated from a pad under the patient, and an image of the precise~     location of the catheter in 3-dimensional space can be seen on a computer screen. The~     catheter is then navigated to various precise locations in the ventricle, producing an~     electromechanical map that distinguishes scarred muscle tissue from healthy~     tissue-information that can be important in guiding treatment.~      When this mapping is completed, the patient will be given a drug called dobutamine to~     increase the heartbeat, and the mapping will be repeated. The heart may also be mapped while~     the heart rate is increased with a pacing catheter to simulate exercise. The test will be~     stopped if adverse side effects develop.~      Patients in the study will also have magnetic resonance imaging (MRI) and PET (positron~     emission tomography) scans to get additional information about the heart muscle, such as~     blood flow and metabolism rate.~   "
274434|NCT00001894|"~     This study will compare two treatments: pacemaker implantation and percutaneous transluminal~     septal ablation (PTSA) for patients with hypertrophic cardiomyopathy (HCM), a condition in~     which the heart muscle thickens and obstructs the flow of blood out of the heart. The reduced~     blood flow can cause chest pain, shortness of breath, palpitations, tiredness,~     lightheadedness and fainting.~      Patients with HCM who cannot be helped by drug therapy may participate in the study. The~     standard treatment for such patients is septal myectomy, an operation in which the surgeon~     shaves the muscle obstructing the blood flow. Another treatment option is implantation of a~     type of pacemaker that causes the heart to contract in a certain way that reduces blood flow~     obstruction and improves symptoms. The pacemaker is implanted under local anesthesia and~     usually takes less than an hour. PTSA is an experimental treatment that may provide a third~     option. In PTSA, a thin tube (catheter) is inserted into the blood vessel that feeds the~     heart muscle causing the blood flow obstruction. A small amount of alcohol is injected~     through the catheter to destroy some of the muscle and relieve the obstruction.~      Candidates will have the following screening tests: chest X-ray, electrocardiogram,~     echocardiogram, exercise tests, exercise radionuclide angiography, exercise thallium~     scintigraphy, Holter monitoring, cardiac catheterization, electrophysiology study, and~     coronary angiography. Participants will be assigned to one of the two treatments groups:~     pacemaker implantation or PTSA. Patients in the PTSA group will also have magnetic resonance~     imaging scans at the start of the study, 3 to 7 days after PTSA, and at the end of the study,~     in order to observe changes in the heart's shape. All patients will fill out a questionnaire~     answering questions about their quality of life.~      Patients' progress will be followed with monthly phone calls. In addition, various tests,~     such as exercise tests and echocardiography, will be done during repeat visits at three and~     six months to measure treatment results. Patients will again complete quality-of-life~     questionnaires at both of those visits.~   "
274435|NCT00001893|"~     The proposed study is a phase II clinical trial of TNFR:Fc therapy in a segmental allergen~     bronchoprovocation model of atopic asthma. The goal of this study is to assess whether~     inhibition of tumor necrosis factor (TNF) bioactivity can attenuate airway inflammation in~     mild-to-moderate allergic asthmatics. This protocol will utilize a randomized, double-blind,~     placebo-controlled trial design. TNF bioactivity will be inhibited via systemic~     administration (e.g., subcutaneous injection) of a dimeric fusion protein consisting of the~     extracellular ligand binding domain of the 75-kilodalton TNF receptor linked to the Fc~     portion of human IgG1 (TNFR:Fc, Immunex). The data generated by this study will address the~     utility of anti-TNF therapy for patients with asthma.~   "
274437|NCT00001885|"~     Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and~     fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid~     arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.~      Data gathered from previous research studies suggest that genetics may play a role in the~     development of PF in patients with rheumatoid arthritis. However, the actual genetic factors~     involved in the disease process have not been identified.~      The goal of this study is to identify the genetic markers in patients with pulmonary fibrosis~     and rheumatoid arthritis.~   "
274438|NCT00001884|"~     Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and~     fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid~     arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.~      Researchers hope to improve their understanding of the disease process involved in PF and RA~     by analyzing specimens collected by bronchoscopy, lung biopsy, lung transplantation, or~     autopsy from patients with these conditions.~      The purpose of this study is to collect specimens from rheumatoid arthritis patients with and~     without pulmonary fibrosis as well as patients with pulmonary fibrosis without associated~     diseases or cause (idiopathic pulmonary fibrosis).~   "
274439|NCT00001883|"~     This study is designed to make sure exercise equipment used by the National Heart, Lung, and~     Blood Institute is working properly. Healthy volunteers will be requested to use P-CCMB~     cardiopulmonary exercise equipment (treadmills and exercise bicycles) two times a month to~     ensure the machines are functioning properly.~   "
274440|NCT00001880|"~     The goal of this research study is to identify other types of cancer (malignant neoplasms)~     that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell~     transplantation.~      Patients with a variety of different types of cancerous tumors that have spread~     (metastasized) and whose conditions have not improved with stand therapy, will be eligible to~     participate. Those patients selected to participate in the study will undergo a procedure~     known as a mini-transplant. The mini-transplant is a transplantation of stem-cells~     collected from a sibling (brother or sister) of the patient. Unlike traditional bone marrow~     transplants, the mini-transplant does not require intense chemotherapy or radiation therapy.~     Because of this, patients experience fewer and less severe side effects.~      This study is open to patients diagnosed with a variety of metastatic solid tumors including~     esophageal, gastric (stomach), colon, rectal, liver tumors (hepatoma), cancer of the biliary~     system (cholangiocarcinoma), cancer of the pancreas, lung, breast, prostate, bone (sarcoma),~     adrenal basal cell, bladder, and adenocarcinomas of unk primary origin.~   "
274441|NCT00001878|"~     The human heart is divided into four chambers. One of the four chambers, the left ventricle,~     is the chamber mainly responsible for pumping blood out of the heart into the circulation.~     There is an inherited condition affecting the heart, passed on through genetics, hypertrophic~     cardiomyopathy (HCM). HCM causes the left ventricle to become abnormally enlarged (left~     ventricular hypertrophy LVH).~      Some patients with the abnormal genes that may cause HCM do not have the characteristic LVH.~     Approximately 20 - 40% of patients with the genetic abnormality (missense mutation of genes~     encoding for sarcomeric protein) actually have an enlarged left ventricle. Because of this,~     researchers believe there may be other factors, along with the genetic abnormality that~     contribute to the development of HCM. Researchers are interested in learning more about~     several factors they suspect may play a role in the development of HCM.~      Specifically, researchers plan to study levels of a hormone and the protein it attaches to,~     which may contribute to the development of an abnormally enlarged heart. Insulin-like growth~     factor (IGF-1) and insulin-like growth factor binding protein (IGFBP) work together with~     growth hormone (GH) in the development and maturation of many organ systems. Previous studies~     have suggested that these hormones affect the development and function of the heart.~      Patients participating in this study will undergo a variety of tests including collection of~     blood samples, echocardiogram of the heart, treadmill exercise test, and continuous~     electrical monitoring of heart activity (Holter monitor).~   "
274442|NCT00001877|"~     Sarcoidosis is a disease most commonly affecting the lungs, but it can also involve lymph~     nodes, skin, liver, spleen, eyes, bones, and glands. The cause of the disease is unknown.~     When it occurs it can produce an inflammatory reaction leading to irreversible organ damage~     and disability.~      In sarcoidosis granulomas can form in various organs (primarily lung) which can lead to its~     dysfunction. Granuloma is formed by clusters of inflammatory cells. The formation of these~     granulomas is influenced by the release of a substance called TNF-alpha (tumor necrosis~     factor alpha) which is found in some white blood cells. A drug known as pentoxifylline (POF)~     is known to markedly reduce the release of TNF-alpha.~      The standard medical treatment for sarcoidosis is steroid therapy. However, steroid therapy~     is associated with significant side effects and often must be stopped. Unfortunately, some of~     these patients can relapse when the steroid therapy is discontinued. Because of this,~     researchers are interested in finding alternative therapies for the treatment of sarcoidosis.~      This study will evaluate the effectiveness of giving POF to patients with sarcoidosis~     currently taking steroids. Researchers will compare the results between patients taking~     steroids with pentoxifylline and those patients taking steroids alone.~   "
274443|NCT00001876|"~     Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and~     fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid~     arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.~      Patients participating in this study will undergo a series of tests and examinations before~     and throughout the study. The tests include blood and urine tests, electrical measures of~     heart function (ECG), chest x-rays, CAT scans, nuclear medicine scans, breathing tests,~     exercise tests, and fiberoptic bronchoscopy.~      The goals of this study are to:~        1. Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis,~        2. Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis,~        3. Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis,~          and~        4. Learn more about the factors that contribute to the development or progression fibrotic~          lung disease.~   "
275011|NCT00000532|"~     To determine if the increase in low density lipoprotein (LDL) cholesterol at the time of~     menopause could be ameliorated or prevented by an intensive dietary intervention. Also, to~     prevent the increase in body weight and associated changes in insulin, glucose, blood~     pressure, triglycerides, and high density lipoprotein cholesterol during the peri- to~     postmenopausal period.~   "
274444|NCT00001874|"~     Magnetic resonance imaging (MRI) and spectroscopy are diagnostic tools that create high~     quality images of the human body without the use of X-ray (radiation). MRI uses different~     levels of magnetic fields to create images of the body and organs. Occasionally, researchers~     will give patients undergoing a MRI an injection of a contrast substance. The contrast~     substance works by brightening areas of the magnetic resonance image.~      In this study researchers plan to use magnetic resonance imaging with contrast substances and~     exercise on normal volunteers in order to evaluate different aspects of its performance.~     Information gathered from this study may be used to develop more specific research studies~     involving MRI....~   "
274445|NCT00001873|"~     Cancers of the blood, sometimes referred to as hematologic malignancies, are disorders of~     bone marrow cells that lead to the failure of the normal function of bone marrow and the~     uncontrolled growth of cancerous cells in the bone marrow. These cancerous cells can spill~     over into the bloodstream and affect other organs causing widespread symptoms. The disease is~     life threatening because it blocks the normal function of the marrow, which is to produce red~     cells (preventing anemia), white cells (preventing infection), and platelets (preventing~     progression).~      Bone marrow transplants are a potential form of therapy for patients with hematologic~     malignancies. However, BMT is a complicated procedure and can be associated with dangerous~     side effects.~      In this study researchers are attempting to find ways to reduce the complications of BMT, so~     that it would be possible to use it more safely and can be offered more patients. In order to~     do this, researchers are developing new techniques to make BMT safer. It requires making~     small changes to the standard procedure, which may improve the outcome.~      The experimental procedures researchers are evaluating are:~        1. <TAB>T-cell depleted peripheral blood progenitor cell (PBPC) transplantation~        2. <TAB> Cyclosporine given immediately after the transplant~        3. <TAB>Add-back of donor lymphocytes~      Patients undergoing these experimental techniques must be monitored closely to see if any~     benefit or harmful effects will occur. Information gathered from this study can be used to~     develop further research studies and potential new therapies for hematologic malignancies.~   "
274446|NCT00001872|"~     Blood contains different kinds of cells, white blood cells, red blood cells, and platelets.~     In order to treat certain diseases, specific cell types can be removed from blood and~     transplanted into patients. The process of removing white blood cells for the treatment of~     leukemia is called apheresis.~      This study will make available blood cell collections from volunteers genetically matched to~     various degrees with recipients in order to test and, if necessary, refine the process of~     removing white blood cell T-lymphocytes.~   "
274447|NCT00001870|"~     Diabetes is a disease characterized by decreased sensitivity to the action on insulin to~     promote sugar (glucose) use and blood vessel relaxation (vasodilation) in muscle. Insulin's~     ability to cause blood vessel relaxation is controlled, in part, by nitric oxide (NO).~      Nitric oxide is a substance produced by the cells lining blood vessel walls (endothelium).~     Increased blood flow to the muscle accounts for increased sugar (glucose) to areas of the~     body. Therefore, if the cells of blood vessel walls (endothelium) are not functioning~     properly it may contribute to insulin resistance.~      Injections of Vitamin C directly into the arteries have been shown to improve blood vessel~     reaction to nitric oxide in diabetic patients. Researchers believe this may be due to Vitamin~     C's ability to increase the levels of nitric oxide in blood vessels.~      The goal of this study is to determine the effects of vitamin C on both insulin sensitivity~     and endothelium function of patients with type 2 diabetes. An additional goal of the study is~     to determine the effects of vitamin C on patients with vitamin C deficiency.~      Patients participating in this study will undergo a series of testes to determine insulin~     sensitivity and blood vessel reactivity. Patients will be divided into two groups. One group~     will receive doses of oral vitamin C. The other group will receive doses of a placebo~     (inactive pill not containing vitamin C). Patients will receive the medications for four~     weeks and then be tested again for insulin sensitivity and blood vessel reactivity.~      Researchers believe that doses of vitamin C in diabetics or patients with vitamin C~     deficiency will improve insulin sensitivity and function of endothelium. Results gathered~     form this study may provide information about vitamin C levels in diabetics and may lead to~     the development of new therapies to treat insulin resistance and endothelium dysfunction.~   "
274448|NCT00001869|"~     Pulmonary lymphoangioleiomyomatosis (LAM) is a rare destructive lung disease typically~     affecting women of childbearing age. Currently, there is no effective therapy for the disease~     and the prognosis is poor.~      In order to better study this disease, the National Heart, Lung, and Blood Institute (NHLBI)~     has developed a registry to keep an official record of patients diagnosed with LAM. This~     research project will collect data from 6 health care centers as well as outside physicians.~     Researchers hope to provide valuable information about the rate of lung destruction and~     quality of life in patients with LAM.~      Patients participating in this study will be followed for 5 years. Tissue collected from~     these patients may contribute to the development of future studies on the disease processes~     of LAM.~   "
274449|NCT00001865|"~     This study will evaluate the safety and effectiveness of Zenapax in controlling recurrent eye~     inflammations associated with Behcet's disease.~      Behcet's disease is usually treated with corticosteroids to suppress inflammation. Other~     medicines such as methotrexate, cyclophosphamide, or azathioprine may also be used. These~     drugs all can have serious side effects, including liver or kidney damage. Zenapax is a~     monoclonal antibody that binds to certain proteins (receptors) on white blood cells,~     preventing them from interacting with a chemical called interleukin-2. Blocking this~     interaction prevents inflammation.~      This study will include 20 patients who had unacceptable side effects from other medicines~     used to treat their disease; did not benefit from standard treatment; and refused standard~     treatment because of possible side effects of the medicines.~      All patients in the study will continue to take their current medicines at the start of the~     study. In addition, one group of patients will receive Zenapax and a second group will~     receive a placebo. The drug or placebo will be infused into the vein at the start of the~     study and every two weeks for the next six weeks, and then every four weeks for the rest of~     the study period (24 months). Each infusion lasts about 15 minutes. Patients will have eye~     examinations at the time of every treatment, and medicines will be added if needed to control~     eye disease. Drugs will be tapered after six months in patients whose eye disease is quiet,~     and readjusted as necessary. Neither the doctors nor the patients will know who is receiving~     placebo and who is receiving Zenapax until the study ends.~      Patients will be given a physical examination, medical history, eye examination, fluorescein~     angiography (special photographs of the retina to evaluate the blood vessels in the eye), and~     blood tests.~      Zenapax was previously studied in 10 patients with uveitis with positive results. The~     patients were able to reduce the other medicines they were taking with minimal side effects.~   "
274461|NCT00001850|"~     This study was designed to allow inpatient and outpatient evaluation of women with a variety~     of reproductive and endocrine-related disorders for purposes of research and physician~     education.~      The evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. In~     some cases, specific laboratory or X-ray studies will be performed to confirm the diagnosis~     or assist in the treatment of the patient. These additional tests will be conducted within~     the guidelines of current gynecologic practice. In some cases, the patient will receive~     medical or surgical treatment for their disorder.~      The purpose of this study is to provide an opportunity for physicians to evaluate women with~     medical conditions of reproduction. These evaluations and treatments will support clinical~     training and research for the accredited training program in reproductive endocrinology at~     the National Institute of Child Health and Human Development (NICHD).<TAB>~   "
275026|NCT00000517|"~     To determine the benefits and risks of oral anticoagulant therapy in reducing embolic stroke~     and systemic emboli in patients with atrial fibrillation without rheumatic heart disease.~   "
274450|NCT00001863|"~     This study will investigate the safety and effectiveness of the drug Leflunomide to treat~     uveitis-an inflammation of the eye caused by an immune system abnormality. Leflunomide~     suppresses immune system activity and has been shown to control autoimmune diseases, such as~     arthritis (joint inflammation), in animals. It has also improved symptoms in patients with~     rheumatoid arthritis, and the Food and Drug Administration has approved it for treating~     patients with this disease. Eye and joint inflammation may have similar causes, and medicines~     for arthritis often help patients with eye inflammation. This study will examine whether~     Leflunomide can help patients with uveitis.~      Patients with uveitis who are not responding well to steroid treatment and patients who have~     side effects from other medicines used to treat uveitis (such as cyclosporine,~     cyclophosphamide, methotrexate or azathioprine) or have refused treatment because of possible~     side effects of these medicines may be eligible for this study. Candidates will be screened~     with a medical history, physical examination, blood test and eye examination. The eye exam~     includes a check of vision and eye pressure, examination of the back of the eye (retina) with~     an ophthalmoscope and the front of the eye with a microscope. They will also undergo a~     procedure called fluorescein angiography to look at the blood vessels of the eye. A dye~     called sodium fluorescein is injected into the bloodstream through a vein. After the dye~     reaches the blood vessels of the eye, photographs are taken of the retina.~      Study participants will be divided into two groups. One group will take 100 milligrams of~     Leflunomide once a day for 3 days and then 20 milligrams once a day for 6 months. The other~     group will take a placebo-a pill that looks like the Leflunomide pill but does not contain~     the medicine. All patients in both groups will also take prednisone. Patients will have~     follow-up examinations at weeks 1, 4, 8, 12, 16, and 24 (6 months) of the study. Each~     follow-up visit will include a repeat of the screening exams and an evaluation of side~     effects or discomfort from the medicine. Those who do well and want to continue their~     assigned treatment after 6 months can continue that treatment for another 6 months and will~     have follow-up exams at months 9 and 12.~   "
274451|NCT00001862|"~     This study will investigate the safety and effectiveness of the drug TNFR:Fc to treat uveitis~     (eye inflammation) in patients with juvenile rheumatoid arthritis. In other studies, TNFR:Fc~     significantly reduced joint pain and swelling in adult patients with rheumatoid arthritis,~     and the Food and Drug Administration has approved the drug for that use. Because medicines~     for arthritis often help patients with eye inflammation, this study will examine whether~     TNFR:Fc can help patients with uveitis.~      Patients with uveitis who are not responding well to standard treatment, such as steroids,~     and patients who have side effects from other medicines used to treat their uveitis or have~     refused treatment because of possible side effects may be eligible for this study. Candidates~     will be screened with a medical history, physical examination, and eye examination. The eye~     exam includes a check of vision and eye pressure, examination of the back of the eye~     (retina), and front of the eye, including measurements of protein and inflammation.~     Candidates will also undergo fluorescein angiography-a procedure in which photographs are~     taken of the retina to see if there is any leakage in the eye's blood vessels. A blood test~     and joint evaluation will also be done.~      Study participants will be given a shot of TNFR:Fc twice a week for up to 12 months and may~     continue other medicines they may be taking, such as prednisone or methotrexate. They will~     have follow-up examinations at week two and months one, two, three and four. Those who wish~     to continue treatment after the fourth month can receive the drug for another eight months~     and will have follow-up exams at months six, nine and 12, and one month after treatment ends.~     Each follow-up visit will include a repeat of the screening exams and an evaluation of side~     effects or discomfort from the medicine.~   "
274452|NCT00001861|"~     This screening protocol is designed to help recruitment patients for National Eye Institute~     (NEI) studies on nystagmus and strabismus. Patients must meet specific requirements of a~     research study, and this protocol serves as a first step for admitting patients to an~     appropriate program.~      Candidates will undergo a medical history, physical examination, eye examination and blood~     test. The eye examination includes measurement of eye pressure and dilation of the pupils to~     fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to~     determine eligibility for a nystagmus or strabismus study. These include routine laboratory~     tests, non-invasive imaging, questionnaires, and other standard tests. If needed, a test~     called oculography may be done to record eye movements. There are two procedures for~     recording and documenting these movements. In the infrared system, the patient wears a pair~     of glasses or goggles and looks at a red light while the head is kept steady. In the search~     coil system, the eye is numbed with anesthetic eye drops and a soft contact lens is placed on~     the eye. Then the patient looks at a red light while the head is held still. Each oculography~     session lasts 20 to 30 minutes. Photographs of the eye may be taken.~      When the screening is completed, patients will be informed of their options to participate in~     a study. Patients who are ineligible for a current study will be informed of alternative~     treatments or options. No treatment is offered under this protocol.~   "
274453|NCT00001860|"~     The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered~     Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with~     macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels.~     Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and~     transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to~     less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly,~     reduce the size of the macroadenomas, produce few side effects, assess the prognostic value~     of baseline pituitary adenoma size, extension and baseline growth hormone level on~     post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each~     treatment type.~   "
274454|NCT00001859|"~     Kidney transplantation is the preferred treatment for most end-stage kidney disease. This~     procedure is limited, however, by two major factors: 1) a shortage of donor organs and 2)~     organ rejection by the recipient. The National Institute of Diabetes and Digestive and Kidney~     Diseases is screening patients with kidney failure or diabetes who may be eligible for~     kidney, kidney and pancreas, or islet cell transplantation.~      Patients in this screening study are not offered treatment. When the screening is complete,~     patients will be offered an opportunity to participate in another institute study, or, if~     there are no active studies appropriate for the patient, other options will be suggested to~     the primary or referring physician. Patients found eligible for a study are not obligated to~     participate.~      Screening for all patients typically consists of blood tests, urinalysis, electrocardiogram,~     PPD tuberculosis screen and pregnancy test. Chest and kidney X-rays and other studies may be~     done on patients determined eligible for a particular study, including transplantation. A~     summary of all test results will be sent to the referring physician unless the patient~     requests otherwise.~   "
274455|NCT00001858|"~     This protocol facilitates the development of methods for determining whether transplant~     recipients have developed immune hyporesponsiveness or tolerance towards their allograft.~     These methods will involve the study of peripheral blood or biopsy tissue obtained at regular~     intervals from patients receiving kidney or combined kidney-pancreas allografts at the Warren~     G. Magnuson Clinical Center. In addition, patients that have previously received a kidney or~     combined kidney-pancreas allograft will be evaluated using assays requiring peripheral blood~     mononuclear cells and/or biopsies. Assays developed under this protocol will be used in~     subsequent protocols to assess the effects of immune modulating treatment regimens and may~     eventually be used to direct clinical care or guide the withdrawal of immunosuppressive~     agents. However, patients enrolled in this protocol will not have any change in treatment~     based solely on the assays developed without being enrolled in an additional study.~   "
274456|NCT00001856|"~     On a yearly basis there are approximately 12,000 kidney transplants in the United States.~     Presently there are approximately 40,000 patients awaiting a transplant with only 5,000~     available donors. Due to the obvious difference between organ supply and demand, live donors~     have become a standard source of kidneys for transplantation.~      Research has proven that kidneys from living donors are superior to cadaveric donors (kidneys~     harvested from a deceased individual). Kidneys from living donors are not exposed to~     extremely low temperature that could increase post-operative problems. They are less likely~     to experience rejection and there is a decreased likelihood that a patient will have to~     undergo post-operative dialysis.~      The objective of this study is to promote the enrollment of healthy individuals to serve as~     kidney donors for patients undergoing research kidney transplantation at the NIH. Potential~     donors will be screened to make sure they are able to survive with a single kidney without~     significant medical risk. Additional tests will be taken to establish compatibility with the~     recipient. Compatible donors will be evaluated to determine which kidney is suitable for~     transplantation. Both the donation and transplantation procedure will be conducted on the~     same day. Appropriate post-operative care and follow-up will be provided at the Clinical~     Center....~   "
274457|NCT00001854|"~     Chronic hepatitis C is a disease of the liver caused by the hepatitis C virus. The disease~     can be serious and even fatal. Approximately 25% of patients with chronic hepatitis C will~     develop cirrhosis and some of these patients will develop cancer of the liver or liver~     failure.~      Presently the disease is treated with a combination of alpha interferon or peginterferon~     (antiviral and immune stimulating drugs) and ribavirin (an antiviral drug). Alpha interferon~     is given by injection three times a week whereas peginterferon is given by injection only~     once a week. Ribavirin is given as a tablet by mouth twice a day. The combination therapy is~     given for 6 to months. About half of the patients given these medications will receive a~     lasting benefit and many patients do not respond well to the combination therapy.~      This study will select up to 50 patients will chronic hepatitis C who have not responded to~     combination therapy or who could not stand the side effects associated with interferon or~     peginterferon therapy. These subjects will be evaluated and undergo liver biopsy to determine~     their present liver condition. If selected as subjects they will be started on single drug~     therapy with ribavirin. The drug will be given orally twice a day at a dose based on the~     patient's body weight.~      The patients will be followed on an out-patient basis. They will we asked to return for~     regular check-ups and blood tests every 2 to 8 weeks for the duration of the study. After 6~     months, the medication will be stopped or adjusted based on the results of the subject's~     blood tests (liver enzymes). A response is considered if a decrease of 50% or more of the~     initial liver enzyme (alanine aminotransferase, ALT) is noted. A complete response will be~     considered if liver enzymes return to normal levels.~      Therapy will be discontinued after 6 months if patients do not respond. However, patients~     that respond to the single drug therapy will continue to receive the medication at a~     decreased dose. The patients will remain on an appropriate dose for up to 8 years with repeat~     liver biopsies at 2, 4 and 8 years to assess progress.~      This study will determine if long-term therapy with ribavirin is safe and effective.~   "
274458|NCT00001853|"~     It is unknown if obesity contributes to the development of heart disease in African American~     men and women.~      This study was created to determine whether there is a relationship between sex and body size~     and the incidence of heart disease in African American men and women. Researchers will~     attempt to associate obesity with the presence of heart disease risk factors. Risk factors~     that will be studied include; total body fat, body fat distribution, fat content of the blood~     (triglyceride concentration, low density lipoproteins [LDL], and high density lipoproteins~     [HDL]), how fast fat is removed from the blood, and how well insulin works in the body.~      Scientific studies have shown that obesity and increased levels of fat content in the blood~     are important risk factors for heart disease in Caucasian women. However, similar studies in~     African American women have failed to show the same correlation. In fact, it appears that~     African American women in all three body weight groupings, nonobese, overweight, and obese~     experience high death rates due to heart disease. In addition, prior research has shown that~     obese African American men tend to have elevated levels of fat in the blood while African~     American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat~     found in the blood) are not seen in non-diabetic obese African American women, it cannot be~     considered a risk factor in this population. This suggests that studies conducted on~     Caucasian women may not provide insight into heart disease risk factors in African American~     women.~      The study will take 120 healthy nondiabetic African American men and women (ages 18-50)~     grouped by sex (60 men and 60 women) and body mass index 3 subgroups; nonobese, overweight~     and obese). Diabetes undeniably increases the risk of heart disease. Therefore patients~     suffering from diabetes will not be included in the study. Candidates for the study will~     undergo a series of tests and examinations over 5 outpatient visits. Subjects will have body~     fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and~     specific blood tests.~      Researchers believe this study will provide significant insight into the causes of obesity~     and heart disease in African Americans.~   "
274459|NCT00001852|"~     This study will follow patients with salivary gland dysfunction to identify the long-term~     course of this disorder and its effects on the mouth, oral function, and overall health.~     Saliva is important in maintaining oral health and comfort. It moistens the mouth, lubricates~     food for easier swallowing, provides enzymes needed to begin the digestive process and~     promotes repair and cleansing of soft tissues of the mouth. Decreased salivary production or~     changes in salivary composition may affect oral and systemic health and cause an increase in~     tooth decay.~      Patients 4 years of age and older with dry mouth symptoms and a diagnosis of primary,~     secondary or incomplete Sj(SqrRoot)(Delta)gren s syndrome or salivary gland dysfunction due~     to radiation may be eligible for this study. Candidates will be screened with a complete~     medical and dental history and blood and saliva tests. Some patients will have a biopsy of~     the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis~     of Sj(SqrRoot)(Delta)gren s syndrome and determine the extent of changes in the salivary~     glands. (A biopsy is the surgical removal of a small piece of tissue for laboratory~     examination.) The ability to taste and smell may also be evaluated, and patients may have an~     ultrasound examination of their swallowing function.~      Participants will have a general oral examination of the teeth and soft tissues of the mouth,~     general physical examination, eye examination and blood tests and will fill out a~     questionnaire on oral health and function. In addition, they will have the following tests~     and procedures:~        -  Identification of possible fungal infection Patients rinse their mouth with 2 teaspoons~          of a salt-water solution and spit it in a sterile container for laboratory examination.~          If a fungal infection is detected, treatment will be offered.~        -  Unstimulated salivary function assessment Saliva production is measured by collecting~          saliva samples through small suction cups connected to collection tubes over the~          salivary gland ducts in the mouth.~        -  Stimulated salivary function assessment A sour-tasting liquid (2% citric acid) is~          applied to the top and sides of the tongue at 30-second intervals to stimulation saliva~          production while saliva is collected using the procedure described above.~        -  Identification of markers of precancerous lesions The salivary gland biopsy done at the~          screening evaluation (or from outside sources) is examined for markers of precancerous~          lesions, as about 5 percent of patients with Sj(SqrRoot)(Delta)gren's syndrome develop a~          tumor called Non-Hodgkin s lymphoma. In some cases, the minor salivary glands may be~          re-biopsied a few years after the screening biopsy.~      Patients will be followed once a year with a comprehensive history and physical examination,~     eye examination, full oral examination, salivary function assessment and questionnaires about~     signs and symptoms of salivary gland dysfunction.~   "
274460|NCT00001851|"~     This study will evaluate the effectiveness of a new bone injection technique for treating~     bone disease in patients with polyostotic fibrous dysplasia or McCune-Albright syndrome. In~     these patients, some bones develop areas with much less mineral, making the bones more prone~     to fracture or deformity and causing pain. This new treatment is intended to reduce the risk~     of fracture, minimize deformities and improve overall function in these patients.~      Patients 4 years of age and older with bone lesions that are highly likely to cause~     significant pain and illness may be eligible for this 2-year study. Participants must be~     simultaneously enrolled in NIDCR's research protocol 98-D-0145 (Screening and Natural History~     of Patients with Polyostotic Fibrous Dysplasia and McCune-Albright Syndrome) or 98-D-0146 (A~     Randomized, Placebo-Controlled Trial of Alendronate in the Treatment of Polyostotic Fibrous~     Dysplasia and McCune-Albright Syndrome).~      Within 14 days of the bone injection procedure, patients will have a medical history, routine~     blood tests, urinalysis and check of vital signs (blood pressure, pulse and temperature) and~     will complete a 30-minute quality-of-life questionnaire. Women of child-bearing potential~     will have a pregnancy test. Patients who do not have recent X-rays and bone density scans~     available for review will have new ones taken. When these studies are completed, patients~     will undergo the bone injection procedure, followed immediately by bone densitometry and~     coned-down X-rays, as follows:~        -  Bone injection - Patients will be given an anesthetic either to make them sleepy or put~          them to sleep completely. A portion of bone marrow will be withdrawn through a needle~          inserted into the hip bone and, at the same time, abnormal bone in the arms and legs~          will be sucked out using a needle. The abnormal bone will be replaced with a mixture of~          bone marrow and collagen (connective tissue protein) injected into the hole in the bone.~          The areas of injection will be closed~        -  Bone densitometry - X-rays of the operated bone and opposite normal bone will be taken.~        -  Coned-down X-rays - Magnified normal X-rays will be taken as close-ups of an active~          lesion.~      Patients will have a history and physical examination by their local physician or at NIH~     every month for the first 4 months after the procedure. Every 6 months after the procedure,~     patients will return to NIH for follow-up, including a physical examination and completion of~     a quality-of-life questionnaire. Imaging studies of the injected site will be done 3, 6, and~     12 months after the procedure.~   "
274462|NCT00001849|"~     Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol.~     Cortisol is produced in the adrenal gland as a response to the production of ACTH in the~     pituitary gland.~      Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic~     production of the hormone ACTH. Meaning, the hormone is not being released from the normal~     site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the~     lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the~     ACTH cannot be found even with the use of extensive imaging studies such as CT scans, MRIs,~     and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source~     of the hormone production is dependent on the changes of anatomy and / or the dose and~     adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH~     production often results in unnecessary pituitary surgery or irradiation.~      Unlike the previously described tests, positron emission tomography (PET scan) has the~     ability to detect pathologic tissue based on physiologic and biochemical processes within the~     abnormal tissue.~      This study will test whether [18-F]-fluorodeoxyglucose (FDG) or use of a higher dose of~     [111In-DTPA-D-Phe]-pentetreotide can be used to successfully localize the source of ectopic~     ACTH production.<TAB>~   "
274463|NCT00001848|"~     Many women with lower abdominal pain have endometriosis. Endometriosis is a condition in~     which the lining of the uterus (endometrium) is found outside of the uterus. The diagnosis of~     endometriosis is usually made at surgery. The treatment of endometriosis includes medical and~     surgical approaches alone or in combination. The hormone estrogen stimulates the growth of~     the endometrium and may also stimulate the growth of endometriosis. Medical therapies that~     act to decrease the level of estrogen can reduce the amount of endometriosis and pain. When~     therapies are discontinued, symptoms often return. In addition, medical treatment for~     endometriosis is expensive and is often associated with weak bones (osteoporosis) and hot~     flashes as a result of low levels of estrogen.~      Surgical treatment is removal or destruction of the endometriosis tissue. Studies show the~     pain from endometriosis is relieved longer with tissue removal than with destruction.~      This study was developed to see if surgery followed by daily doses of Raloxifene (Evista) is~     effective in reducing pain, for a longer time than surgery in combination with a placebo~     (inactive sugar pill) treatment. Raloxifene acts like estrogens in some tissues and not~     like estrogens in others. Postmenopausal women receiving Raloxifene for the prevention of~     osteoporosis had an increase in bone density and an improvement of their blood lipids (fat~     content in the blood). However, unlike estrogen, Raloxifene does not promote the growth of~     breast tissue or the uterus. If Raloxifene blocks estrogen action in the lining of the uterus~     (endometrium) of reproductive age women, as it does in post-menopausal women, it may also~     limit the growth of endometriosis and prevent the return of pain.~   "
274464|NCT00001846|"~     This protocol is designed to provide a mechanism for the Department of Transfusion Medicine,~     Clinical Center to collect and process blood components from paid, healthy volunteer donors~     for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory~     use. Donors meeting research donor eligibility criteria will be recruited to donate blood and~     blood components by standard phlebotomy and apheresis techniques. The investigational nature~     of the studies in which their blood will be used, and the risks and discomforts of the~     donation process will be carefully explained to the donors, and a signed informed consent~     document will be obtained. Donors will be compensated according to an established schedule~     based on the duration and discomfort of the donation. NIH and FDA investigators requesting~     blood components for research use will be required to submit an electronic (Web-based) memo~     of request, briefly describing the nature of the research, and providing assurance that~     samples provided through this protocol will be used solely for in vitro and not for in vivo~     research. This protocol also provides a detailed schema for careful and frequent laboratory~     safety monitoring of repeat research apheresis donors.~      Blood components for research use will be distributed with a unique product number, and the~     DTM principal and associate investigators will serve as the custodians of the code that links~     the product with a donor s identity. The nature of the in vitro studies in which the blood~     and components collected in this study will be used is not the subject of this protocol, and~     is not possible to describe, since it involves basic investigative efforts in greater than~     170 different NIH and FDA laboratories. The intent of this protocol is not to approve the~     research itself, but to provide adequate and complete informed consent for the donor, and to~     assure that the education, counseling, and protection of the study subjects (research blood~     donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal~     regulatory standards...~   "
274465|NCT00001845|"~     This study will evaluate magnetic resonance imaging (MRI ) methods for measuring changes in~     the brain's blood flow during hypercapnia (a condition of excess carbon dioxide in the~     blood). MRI is a diagnostic tool that uses a large magnet and radio waves to produce images~     of the body without X-rays.~      Healthy normal volunteers in this study may have as many as six MRI scans over a 2-year~     period. For this procedure, the person lies on a stretcher placed in a strong magnetic field~     produced by the MRI machine. During the scan, the person's blood carbon dioxide (CO2 ) levels~     will be increased either by: 1) breathing air mixtures containing up to 5% CO2; or 2)~     receiving an intravenous (I.V.) injection of a drug called acetazolamide.~      Persons who breathe CO2 will have their heart rate, blood pressure and oxygen levels~     monitored throughout the procedure. Those receiving acetazolamide will have the drug injected~     intravenously (I.V.) into an arm vein. If the volunteer experiences any unpleasant side~     effects from the CO2 or acetazolamide, the study will be stopped.~      The information gained from this study will be used to develop better ways to study brain~     function, possibly leading to better diagnostic and treatment methods.~   "
274466|NCT00001844|"~     This study will evaluate new magnetic resonance imaging (MRI ) methods using a MRI machine~     more powerful than those in most hospitals. MRI is a diagnostic tool that uses a large magnet~     and radio waves to produce images of the human body. It can also provide information about~     brain chemistry and physiology. This study will use the new MRI hardware and methods to~     measure blood flow and metabolism in regions of the brain during simple tasks, such as~     listening to tones or watching flashing checkerboards.~      Healthy normal volunteers will undergo MRI scanning. For this procedure, the person lies on a~     stretcher that is moved into a MRI machine, which produces a strong magnetic field. A special~     lightweight coil is placed on the person's head to obtain better pictures. The scan time~     ranges from 20 minutes to 2 hours, with the average scan lasting between 45 and 90 minutes.~      During the MRI, the person may be asked to perform simple tasks, such as listening to tones~     or watching a screen, tapping fingers or moving a hand. More complex tasks may require~     thinking about tones or pictures and responding to them by pressing buttons.~      The images produced in this study will be compared with those produced using standard MRI.~     The results will be used to develop improved imaging methods for better patient care and~     research.~   "
275012|NCT00000531|"~     To evaluate if use of an implantable cardiac defibrillator (ICD) results in reduction in~     total mortality, when compared with conventional pharmacological therapy, in patients~     resuscitated from sudden cardiac death who are otherwise at very high risk of mortality from~     arrhythmic causes.~   "
274467|NCT00001842|"~     This study will examine the feasibility of giving cell growth stimulants to granulocyte~     donors the same day of donation rather than the day before.~      People who donate granulocytes (infection-fighting white blood cells) for transfusion to~     patients with severe white cell deficiencies are often given a steroid called dexamethasone~     and a growth factor called G-CSF the day before donation. These drugs stimulate white cell~     production, allowing many more cells to be collected than would otherwise be possible. A~     single dose of G-CSF given to healthy people increases their white cells counts by four to~     five times the next day.~      It would be preferable, however, to give G-CSF the same day of donation, if possible.~     Therefore, this study will measure white cell counts in healthy people at various intervals~     after being injected with G-CSF alone and G-CSF with dexamethasone. The study will compare~     the following: granulocyte counts at seven different intervals after injection of the drug or~     drugs; the effects of G-CSF injected through a vein or under the skin; and the effects of~     giving G-CSF alone or with dexamethasone.~      Each participant will undergo four procedures, each four weeks apart as follows: donate a~     small blood sample; receive an injection of G-CSF under the skin or into a vein; and take~     either two dexamethasone tablets or two placebo tablets.~      Small blood samples will then be drawn 1, 2, 4, 6, 8, and 24 hours after the drugs are given.~     Participants will answer questions about how they feel before the drugs are given and at the~     various intervals after taking the drugs.~   "
274468|NCT00001841|"~     Magnetic Resonance Angiography (MRA) is a method used to evaluate arteries and veins without~     the use of invasive catheters or x-rays (radiation). MRA technique has been continuously~     improving and has become more accurate at diagnosing problems of narrowing in blood vessels.~     However, MRA has a difficult time detecting narrowing in small blood vessels, limiting its~     use to large arteries.~      The purpose of this study is to recruit patients diagnosed with or suspected of having,~     atherosclerosis (hardening of the arteries) to participate in a series of new~     state-of-the-art diagnostic tests using MRA.~      This study is a combined effort between the National Institutes of Health (NIH), Uniformed~     Services University of the Health Sciences (USUHS), and General Electric Medical Services and~     is supported a Cooperative Research Agreement is to (CRADA).~      The goal of this study is to improve MRA to the point that it can reliably replace diagnostic~     x-ray catheter angiography in the evaluation of patients with atherosclerosis.~   "
274469|NCT00001837|"~     This research study is designed to work in cooperation with another study being conducted by~     the National Cancer Institute. The National Cancer Institute (NCI) is studying the effects of~     a drug called raloxifene on premenopausal women believed to have a high risk of developing~     breast cancer (98-C-0123).~      In this study, researchers are interested in learning about the effects of raloxifene on the~     uterus and ovaries of the women participating in the NCI study. To do this researchers plan~     to conduct ultrasounds on the patients enrolled in the NCI study. In addition researchers~     plan to take samples of the lining of the uterus in these patients (endometrial biopsy) if~     found to be necessary.~      The purpose of this study is to determine the reproductive effects of raloxifene on women who~     have normal functioning ovaries by taking ultrasounds of the ovaries and lining of the uterus~     (endometrium).~   "
274470|NCT00001836|"~     Electron beam computed tomography (EBCT) has been regarded as the state-of-the-art~     investigation for detecting and quantitating coronary artery calcification. However, EBCT is~     expensive, and the asymmetric gantry geometry makes it less useful for routine scanning;~     thus, EBCT is not readily available to the general population. Recent reports have shown that~     volumetric (also known as helical or spiral) scanners, which are much more commonly~     available than EBCT, can detect coronary artery calcifications. Updated software available to~     the NIH which will allow for EKG gating of volumetric scans should improve the quality of the~     images, and thus improve the ability to accurately quantitate coronary calcification by~     volumetric scanners. We would like to compare the results of volumetric scans with that of~     standard EBCT in order to characterize similarities and differences between the two scanning~     techniques. We propose to obtain EBCT and volumetric CT scans of the coronary arteries in a~     group of patients with known or suspected coronary artery disease and to calculate the~     calcium score by each method. Our primary analysis will be a comparison of the sensitivities~     of the two methods.~   "
274471|NCT00001835|"~     Oxaliplatin is an experimental anti-cancer drug that can shrink tumors such as colon cancer.~     However, because this drug can damage the kidneys, it is necessary to determine what doses of~     the drug can safely be given to patients with poor kidney function.~      Patients with advanced cancer, poorly functioning kidneys, and no good standard treatment~     options are eligible for this study. Candidates will be screened with imaging tests, such as~     CT and MRI scans, to determine the size and location of the cancer and with blood and urine~     tests to evaluate kidney and liver function.~      Study participants will receive oxaliplatin intravenously (through a vein) every 3 weeks for~     as long as the cancer is under control and there are no serious side effects from the drug.~     If significant side effects develop, the dosage will be reduced, or the drug will be stopped.~     Blood tests to measure blood cell counts will be done at least once a week, and CT scans,~     chest X-rays, and MRIs will be done about once every 6 weeks to assess the tumor's response~     to the treatment. Additional blood tests will be done at the beginning of the first two~     treatment cycles to measure the amount of oxaliplatin in the blood, and urine will be~     collected during the first 24 hours of drug treatment to determine how much drug is~     eliminated by the body in urine.~   "
274485|NCT00001781|"~     Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown,~     but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that~     cause the body's immune system and natural defenses to attack healthy cells. In the case of~     MS, the immune system begins attacking myelin, the cells that make up the sheath covering~     nerves. Without myelin nerves are unable to transmit signals effectively and symptoms occur.~      Researchers are interested in testing the safety, tolerability, and effectiveness of a new~     therapy (CGP77116) for Multiple Sclerosis (MS). CGP77116 is a small protein similar to the~     protein in myelin. CGP77116 is designed to modify the immune reaction that destroys normal~     myelin. CGP77116 is an experimental therapy meaning it has not been approved by the U.S. Food~     and Drug Administration. However, in preliminary studies on animal it has been shown to be~     effective at modifying the autoimmune reaction associated with the development of MS.~      The purpose of this study is to assess the safety and effect of CGP77116 on disease activity~     in patients with Multiple Sclerosis as measured by magnetic resonance imaging (MRI) and~     immunological studies.~      The study is broken into three parts:~      I) BASELINE: in the first part of the study patients will undergo 6 MRIs over a 5 month~     period. During this time, patients will be evaluated based on the presence of MS lesions seen~     on MRI. Patients whose MS lesions are highly active will be entered into the second part of~     the study.~      II) TREATMENT: in the second part of the study, patients with active MS lesions will begin~     receiving CGP77116. The drug will be given by injection once a week for one month and then~     once a month for 8 additional months.~      III) FOLLOW-UP: in the third and final part of the study, patients will undergo an MRI every~     2 months for 6 months and then every 3 months for 6 additional months. The results of the~     MRIs will be used to measure the effectiveness of CGP77116.~   "
274472|NCT00001832|"~     This experiment will test the safety and effectiveness of a treatment for melanoma in which~     certain lymphocytes (a type of white blood cell) are taken from the patient, grown in the~     laboratory, and returned after the patient's immune system has been weakened with~     immune-suppressing drugs. Some patients will also receive interleukin-2 (IL-2), a drug that~     may enhance the activity of the re-infused lymphocytes.~      Patients with metastatic melanoma (melanoma whose tumor has spread) who have been treated~     unsuccessfully with gp100 vaccination may participate in this study. They will undergo~     apheresis or a tumor biopsy, or both, to collect lymphocytes. In apheresis, whole blood is~     drawn through a needle in the arm. A machine separates the blood components and removes the~     white cells. The rest of the blood is returned to the donor through a needle in the other~     arm. A biopsy is a surgical procedure to remove a small piece of tumor tissue.~      Several weeks before the lymphocytes are collected, patients will receive injections of~     growth colony stimulating factor (G-CSF) every day for five days. This drug stimulates white~     cell production, permitting as many cells as possible to be obtained during collection. The~     lymphocytes will then be grown in larger numbers in the laboratory.~      Seven days before the cells are re-infused, the patient is admitted to the hospital and a~     catheter (small tube) is placed in a large vein in the chest or neck. Two drugs,~     cyclophosphamide and fludarabine, are given through the tube. These drugs suppress the immune~     system so that it will not interfere with the work of the reinfused lymphocytes. The~     lymphocytes are then injected through the catheter over a 30-minute period. After the~     infusion, patients who receive IL-2 will be given the drug in a high dose over a 15-minute~     period every eight hours for up to five days. Patients whose condition does not permit~     high-dose IL-2, such as those with a heart condition or lung problem, may receive a low-dose~     regimen, with the drug given as a shot under the skin of the thigh or abdomen for five days~     followed by a 2-day break, continuing for a total of six weeks. These patients receive a~     higher dose the first week and then half that dose the next five weeks.~      Blood and tissue samples will be taken before and during the study to evaluate the size of~     the tumor and assess treatment. If, 3-5 weeks after therapy is completed, the patient's tumor~     has stabilized or shrunk, the entire treatment, except for chemotherapy, may be repeated two~     more times.~   "
274473|NCT00001830|"~     Allogeneic peripheral blood stem cell transplantation (PBSCT) is primarily limited by~     graft-versus-host disease (GVHD). In murine models, we have demonstrated that donor CD4+ T~     cells of Th1 cytokine phenotype (defined by their secretion of IL-2 and IFN-gamma) mediate~     GVHD. In contrast, donor CD4+ T cells of Th2 phenotype (defined by their secretion of IL-4,~     IL-5, and IL-10) do not generate GVHD, and abrogate Th-1-mediated GVHD. Importantly, we have~     demonstrated that enrichment of murine allografts with Th2 cells reduces GVHD without~     impairing the ability of donor T cells to prevent graft rejection. These studies indicate~     that the administration of Th2 cells after allogeneic transplantation represents a strategy~     for achieving alloengraftment with reduced GVHD.~      In addition to GVHD, allogeneic PBSCT has been limited by the toxicity associated with~     conventional myeloablative preparative regimens. Such regimens, which typically utilize total~     body irradiation (TBI) and high-dose chemotherapy, were once considered essential for the~     prevention of graft rejection. However, recent clinical studies have shown that~     non-myeloablative doses of fludarabine-based chemotherapy can result in alloengraftment. In~     murine models, we have demonstrated that severe host T cell depletion induced by combination~     fludarabine and cytoxan can prevent even fully-MHC mismatched marrow graft rejection.~     Although non-myeloablative regimens may reduce regimen-related toxicity, such transplants~     have been associated with a 30 to 40% incidence of severe acute GVHD that is similar to rates~     observed with myeloablative regimens. Because non-myeloablative regimens appear to be~     associated with reduced regimen-related toxicity, we have elected to conduct this phase I~     study of Th2 cells in the setting of an immunoablative (non-myeloablative) preparative~     regimen.~      Patients with leukemia in clinical remission, and patients with refractory lymphoid~     malignancy will be candidates for this HLA-matched allogeneic PBSCT protocol. Patients will~     receive novel induction regimen (fludarabine and EPOCH) and transplant preparative regimen~     (fludarabine and cytoxan) designed to maximally deplete host immune T cells capable of~     mediating graft rejection. After induction and preparative regimen chemotherapy, patients~     will receive an unmanipulated, G-CSF mobilized PBSC graft. In the initial six patients~     receiving this transplant procedure at the NCI, graft rejection has been successfully~     prevented (100% donor chimerism by day 30 post-transplant). Importantly, GVHD has been~     observed in all six patients, with three of the six patients developing severe GVHD (grade~     III). Given that this regimen successfully achieves donor engraftment, and is associated with~     significant GVHD, this transplant regimen represents an excellent clinical setting for the~     evaluation of Th2 cells.~      Using this non-myeloablative allogeneic PBSCT approach, we will perform a Phase I study to~     evaluate the safety and feasibility of administering donor Th2 cells on day 1~     post-transplant. Prior to transplantation, donor CD4+ T cells will be stimulated in vitro~     using culture conditions that support the generation of donor CD4 cells of the Th2 cytokine~     profile. If this Phase I study demonstrates that Th2 cell administration is safe and~     feasible, a Phase III study will be performed to evaluate whether Th2 cell administration~     reduces the incidence and severity of GVHD. Successful implementation of this Th2 strategy~     will greatly reduce the morbidity and mortality associated with allogeneic PBSCT, and may~     also represent an approach to stem cell transplantation in patients lacking an HLA-matched~     donor.~   "
274474|NCT00001827|"~     This study will examine whether vaccination with a p53 peptide can boost an immune response~     to ovarian cancer and what the side effects are of the vaccine.~      Many patients with ovarian cancer have an altered (mutated) gene called p53 that causes the~     production of abnormal proteins found in their tumor cells. The body s immune system may try,~     unsuccessfully, to fight these abnormal proteins. In this study, ovarian cancer patients with~     a p53 abnormality will be vaccinated with a p53 peptide a part of the same abnormal protein~     found in their tumor to try to boost their body s immune response to the cancer.~      Patients will be divided into two groups. Group A will have four p53 peptide vaccinations~     three weeks apart, injected under the skin. The injection will include a drug called ISA-51,~     which increases the effect of the vaccine. This group will also receive two other drugs that~     boost the immune system, IL-2 and GM-CSF. Group B will have four p53 peptide vaccinations~     three weeks apart. The peptide will be mixed with the patient s own blood cells and infused~     into a vein. This group will also receive IL-2, but not GM-CSF.~      All study candidates will be tested to see if their cancer has a p53 abnormality and if their~     immune system mounted a defense against it. These tests may include a tumor biopsy (removal~     of a small part of the tumor for microscopic examination); lymphapheresis (a procedure to~     take blood, remove white blood cells called lymphocytes, and return the red cells); and an~     immune response test similar to a skin test for tuberculosis. During the study, patients will~     have additional skin tests and blood tests.~   "
274475|NCT00001826|"~     This study will continue to follow children who participated in an earlier National Cancer~     Institute trial of HIV treatment with a protease inhibitor. Children in this study will~     receive a combination of at least three drugs that include at least one protease inhibitor~     and one reverse transcriptase inhibitor.~      The study will examine to what extent these drugs can restore immune function in HIV-infected~     children and over what length of time. It will look at changes in the amounts of virus and~     the specific types of immune cells in the body over the 96-week trial period. It will also~     examine patients' immune system response to influenza and tetanus vaccinations.~      The children will either continue to receive the anti-HIV drugs they have been taking, or~     their medicines will be changed to a different combination of protease inhibitor and reverse~     transcriptase inhibitor. Before and during the study, patients will undergo various tests,~     including a physical examination, blood tests and chest X ray, immune response tests, CT~     scan, eye examination, electrocardiogram and echocardiogram. A procedure called apheresis may~     be done to collect white blood cells. In this procedure, whole blood is drawn similar to~     donating blood, the white cells are separated out by a machine, and the red cells are~     returned to the body.~   "
274476|NCT00001823|"~     Background:~      The NCI Surgery Branch has developed experimental therapies that involve taking white blood~     cells from patients' tumor or from their blood, growing them in the laboratory in large~     numbers, and then giving the cells back to the patient.~      Objective:~      This study will allow patients to under screening and evaluation for participation in NCI~     Surgery Branch Protocols~      Eligibility:~      Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment~     Protocol~      Design~      Patients will undergo testing and evaluations as required by the appropriate NCI Surgery~     Branch Treatment protocol~   "
274477|NCT00001813|"~     Four rare genetic diseases, xeroderma pigmentosum (XP), Cockayne syndrome (CS), the XP/CS~     complex and trichothiodystrophy (TTD) have defective DNA excision repair although only XP has~     increased cancer susceptibility. We plan to perform careful clinical examination of selected~     patients with XP, XP/CS, CS, or TTD and follow their clinical course. We will obtain tissue~     (skin, blood, hair, buccal swabs) for laboratory examination of DNA repair and for genetic~     analysis. We hope to be able to correlate these laboratory abnormalities with the clinical~     features to better understand the mechanism of cancer prevention by DNA repair. Patients will~     be offered counseling and education for cancer control.~   "
274478|NCT00001807|"~     Central nervous system toxicity is a recognized side effect of certain therapies for cancers,~     particularly cranial irradiation, intrathecal therapy or systemic high-dose chemotherapy. The~     pathophysiologic mechanisms and clinical manifestations vary. Previous studies defining MRI~     changes and correlating these with neurocognitive deficiencies have been inconsistent. Recent~     advances in brain imaging may help to better define neurotoxic effects. (1)H-NMRS is a~     noninvasive method of obtaining in vivo biochemical information from the brain. It has been~     used to study patients with CNS disorders, including neuronal disorders. In this study,~     (1)H-NMRS will be used to objectively characterize CNS toxicities in patients with cancer who~     are receiving potentially neurotoxic therapies. In addition, we will retrospectively evaluate~     patients with known or suspected neurotoxicity associated with cancer therapy, to determine~     if changes in spectroscopic patterns are associated with CNS toxicity.~   "
275027|NCT00000516|"~     To determine if enalapril treatment of left ventricular dysfunction (LVD) due to ischemic or~     hypertensive heart disease led to reduced mortality and morbidity in symptomatic and~     asymptomatic patients. There were a Prevention Trial, a Treatment Trial, and a registry.~   "
274479|NCT00001806|"~     In 1997, the Genetics Department of the NCI Medicine Branch helped establish a breast cancer~     genetics program at the National Naval Medical Center s Breast Care Center. Genetic~     education, counseling, and germline testing for BRCA1 and BRCA2, two genes which confer~     increased lifetime risks for breast and ovarian cancer, were offered under a Navy~     IRB-approved study. Sixty participants received education and counseling on that protocol, 49~     of whom chose to have genetic testing. The education and counseling, provided by oncology~     nurses trained in cancer genetics, focused on preparing participants to make well-informed~     decisions about testing. Included were information on cancer and genetics; hereditary~     breast/ovarian cancer syndrome; risks, benefits and limitations of BRCA1/BRCA2 testing; and~     screening and risk reduction options for high-risk individuals. Through our experience with~     this study, we devised two different methods of providing this information. Both of these~     methods were well received and appear to be equally effective, as measured by knowledge~     assessments before and after the sessions and subjective evaluation by the participants. We~     will now study them in a randomized fashion in the current protocol, to better evaluate~     whether one method is preferable. Ultimately we hope to be able to make recommendations that~     will allow for access to genetic education and counseling for more individuals in a more cost~     efficient manner.~   "
274480|NCT00001803|"~     The Von Hippel-Lindau (VHL) Disease Genetic Epidemiology Study is a family-based case-control~     study to be conducted by the National Cancer Institute. The study subjects are 603~     individuals who were determined to belong to families with VHL disease confirmed through~     screening under NIH protocol #89-C-0086 between 1988 and 1998. There are 293 patient~     volunteers with VHL disease and 310 volunteer patients free of VHL disease, most of whom have~     already had genetic testing for mutations in the VHL gene. Adults as well as children aged 13~     - 17 will be included. All subjects will give informed consent prior to participation; for~     minor subjects, assent will be obtained from the minor and consent from the parent/guardian.~     This protocol provides the potential to benefit people with VHL disease (although not~     necessarily the study subjects themselves) and possibly people with sporadic (non-hereditary)~     forms of the tumors which occur in VHL disease. The risks and discomfort associated with this~     study are minor.~      The present protocol is a new epidemiologic component to VHL research at NIH which will~     relate the expression of VHL tumors to lifestyle factors (tobacco and alcohol use; physical~     activity), occupational exposures, reproductive and hormonal factors, demographic factors,~     medication use, diet, and putative susceptibility genes. Information will be collected by~     telephone interview and a written, self-administered diet questionnaire. A cheek cell sample~     will be obtained for analyses of genetic polymorphisms. Medical records will be obtained to~     document events reported by the subject at interview. Primary comparisons will be between VHL~     patients with a particular manifestation and VHL patients who are free of that condition.~     Additional comparisons may be made with unaffected family members who lack a mutation in the~     VHL gene, as appropriate.~   "
274481|NCT00001788|"~     The purpose of this study is to evaluate patients with primary immunodeficiency disorders to~     identify patients with mutations of the genes for the following proteins: Jak3, STAT1, STAT4,~     interleukin-7, interleukin-7 receptor, interleukin-12 receptor subunits, and others.~      Patients will undergo screening history, physical examination, and clinical laboratory~     evaluation at referring institutions and tissue samples, or cell lines will be sent to the~     NIH. We will establish cell lines if necessary, prepare DNA and RNA for molecular genetic~     analysis and study cytokine signal transduction in patient cell lines.~   "
274482|NCT00001785|"~     HTLV stands for human T cell leukemia virus. HTLV-1 is a virus that attacks specific kinds of~     white blood cells called T cells. T cells are part of the natural defense system of the body.~     HTLV-1 has been associated with leukemia and lymphoma. In addition, approximately 1% of all~     patients infected with HTLV-1 develops a condition known as HTLV-1 associated myelopathy~     (HAM) / tropical spastic paraparesis (TSP).~      Currently there is no clearly defined, effective treatment for patients with HAM/TSP.~     Steroids have been used as therapy but have only been able to provide temporary relief of~     symptoms. Human interferon is a small protein released from different kinds of cells in the~     body. Interferon has been known to have antiviral and immunological effects and has been used~     to treat hepatitis and multiple sclerosis. Interferon Beta is released from cells called~     fibroblasts. These cells play a role in the production of connective tissue.~      The purpose of this study is to evaluate the possible role of recombinant interferon beta~     (Avonex) in treatment of HAM/TSP. The study is broken into three phases, a pre-treatment~     phase, a treatment phase, and a post-treatment phase. The total duration of the study will be~     44 weeks.~      Patients participating in this study will receive injections of Avonex 1 to 2 times a week.~     Throughout the study patients will regularly submit blood samples and undergo diagnostic~     tests such as MRI and measures of somatosensory evoked potentials.~   "
274483|NCT00001784|"~     Dystonia refers to a condition characterized by involuntary muscle contractions that may~     cause pain, abnormal posture, or abnormal movements. The cause of dystonia is unknown, but~     some researchers believe it is a result of overactivity in the areas of the brain responsible~     for movement (basal ganglia).~      Lidocaine is a drug used for the treatment of irregular heartbeats. It is given by injection.~     Recent studies have shown that lidocaine is also effective for the treatment dystonia.~     Mexiletine is a drug similar to lidocaine used for irregular heartbeats that can be taken by~     mouth.~      Researchers would like to test the effectiveness of Mexiletine for the treatment of dystonia.~     Patients participating in the study will be divided into two groups;~      Group 1 will take Mexiletine for six weeks then stop. They will remain drug free for one week~     then begin taking a placebo inactive sugar pill for an additional six weeks.~      Group 2 will take a placebo inactive sugar pill for six weeks then stop. They will remain~     drug free for one week then begin taking a Mexiletine for an additional six weeks.~      Throughout the study researchers will test the effectiveness of the treatment by evaluating~     patients using clinical rating scales and neurophysiological studies. In addition,~     researchers will test patient's reflexes in an attempt to find out where mexiletine works in~     the nervous system.~   "
274484|NCT00001783|"~     The purpose of this study is to determine if giving amphetamines along with standard~     rehabilitation speeds motor recovery after a stroke. In addition, if motor recovery is~     improved, the study will also identify the areas of the brain involved with the recovery.~      Researchers will use motor function ratings, PET scans, functional MRI (fMRI),~     electroencephalographs, and transcranial magnetic stimulation (TMS) to evaluate patients.~      Patients participating in the study will be placed in one of two groups;~        1. Patients receiving dextroamphetamine and routine Rehabilitation Medicine~        2. Patients receiving a placebo sugar pill and routine Rehabilitation Medicine~      Patients that have improved motor recovery will undergo neuroimaging and neurophysiological~     studies to identify areas of the brain involved.~   "
274486|NCT00001780|"~     Transcranial Magnetic Stimulation (TMS) is a non-invasive technique to gather information~     about brain function. It is very useful when studying the areas of the brain related to motor~     activity (motor cortex, corticospinal tract, spinal cord and nerve roots). The procedure is~     conducted by transmitting a magnetic signal into the brain to stimulate an area of the body.~     Electrodes (small pieces of metal taped to areas of the body) are used in order to measure~     electrical activity. A magnetic signal is sent from a metal instrument held close to the~     patient's head, to an area of the brain responsible for motor activity of a certain area of~     the body. The electrodes pick up and record the electrical activity in the muscles.~      This study will employ the use of TMS to diagnose neurological disorders that affect the~     motor cortex or the corticospinal tract. Normal subjects are sometimes studied to investigate~     normal activity of the nervous system and to train doctors in clinical neurophysiology and~     electrodiagnostic medicine at the National Institutes of Health (NIH).~   "
274487|NCT00001778|"~     Objective:~      Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis~     (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with~     the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by~     monitoring clinical progression of patients longitudinally. Additionally, we will attempt to~     define the virological and immunological changes of HAM/TSP.~      Study Population:~      Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible~     to participate in this protocol. Asymptomatic seropositive individuals and individuals with~     indeterminate HTLV-1 serology are also eligible to participate.~      Design and Outcome Measures:~      A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP~     will be accomplished through periodic testing and evaluation. Asymptomatic seropositive~     individuals, those with seroindeterminate HTLV-I serology and normal volunteers may serve as~     controls. Longitudinal standardized neurological examinations will be performed. Longitudinal~     samples of serum, plasma, and lymphocytes may be obtained from participants. Lumbar punctures~     may be performed on all participants. These samples will be used virological and~     immunological assays. A focus is on the relationships between the characteristics of viral~     infection, the immune response, and the genetic makeup.~   "
274488|NCT00001776|"~     Imaging studies of the brain have revealed the different areas involved in the processes of~     learning and reasoning. However, the specific role these regions play in these processes, or~     if stimulating these areas can improve these processes is unknown.~      Researchers would like to use repetitive transcranial stimulation (rTMS) to better understand~     the roles of individual brain regions on the processes of learning and reasoning. Repetitive~     transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet~     with a figure-eight coil on the patient's scalp, and rapidly turning on and off the magnetic~     flux. This permits non-invasive, relatively localized stimulation of the surface of the brain~     (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location,~     intensity and frequency of the magnetic pulses.~      The purpose of this study is to use rTMS to help determine the roles of different brain~     regions in the development of implicit learning of motor sequences and analogic reasoning. In~     addition, researchers hope to evaluate if stimulation of these regions speeds up the process~     of learning or analogic reasoning.~   "
274489|NCT00001771|"~     Abnormalities in the re-uptake of dopamine and serotonin have been described in various~     neuropsychiatric disorders and substance abuse. [I-123] Beta-CIT is a recently developed~     radioligand for SPECT imaging of dopamine and serotonin transporters. [I-123]Beta-CIT SPECT~     has been used at the SPECT-lab of the Clinical Brain Disorders Branch in over fifty subjects~     without adverse events. Due to the trace concentrations used, a pharmacological effect of~     Beta-CIT is unlikely and has not been observed. The purpose of this study is to use Beta-CIT~     and SPECT to study the expression of dopamine and serotonin transporters in vivo in normal~     controls and various patient populations to address hypothesized abnormalities of the~     transporters in different disorders and to understand the effects of genetic variations in~     the genes of these transporters on their in vivo expression.~   "
274490|NCT00001770|"~     Often women are prescribed hormone replacement therapy (HRT) during the perimenopause or~     menopause.~      Hormone replacement therapy includes both estrogen and progesterone. The estrogen component~     of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones, but~     estrogen also increases the risk of uterine cancer. The progesterone component of the HRT~     (progestin) works to prevent the increased risk of uterine cancer.~      There is evidence that some women experience unpleasant mood symptoms (such as irritability,~     depressed mood and anxiety) while receiving hormone replacement therapy (HRT) while taking~     the progestin / progesterone component of the HRT.~      This study is designed to evaluate the ability of progestins to produce negative mood~     symptoms in women. Researchers intend on doing this by comparing the effects of~     medroxyprogesterone acetate (Provera) and a placebo inactive sugar pill. Patient's moods will~     be monitered based on their response to questionnaires answered in the outpatient clinic and~     at home.~      This research will attempt to answer the following questions:~        1. Are progestins associated with changes in mood during hormone replacement therapy?~        2. If progestins are associated with mood disturbance, is it because they are blocking the~          beneficial effects of estrogen?~   "
274491|NCT00001766|"~     This study examined the interactions of various drugs used to treat HIV infection in order to~     design larger studies of possible combinations for people who continue to have high viral~     levels despite combination therapy.~      HIV-infected patients 18 years of age and older who have a viral load of at least 500~     copies/mL; who have received 20 weeks of protease inhibitor therapy, with the same protease~     inhibitors in combination therapy for the last 12 weeks; and who have never been treated with~     abacavir, amprenavir or efavirenz were enrolled.~      All patients will receive 600 milligrams a day of efavirenz (a non-nucleoside reverse~     transcriptase inhibitor); 300 mg twice daily of abacavir (a nucleoside analog); and 1200 mg~     twice a day of amprenavir (a protease inhibitor). In addition to these drugs, six patients~     will receive 500 mg twice a day of ritonavir (a protease inhibitor); six patients will~     receive 200 mg twice a day of ritonavir; and 10 will receive 1250 mg twice a day of~     nelfinavir (a protease inhibitor).~      Patients in the two ritonavir groups (500-mg and 200-mg dose groups) took abacavir and~     amprenavir for one week and then come to the clinic for blood tests to measure drug levels~     before taking their morning pills and at 1/2, 1, 2, 4, 8, and 12 hours after taking the~     medicines. They will then add ritonavir to their treatment regimen. After one week, they will~     return for blood tests as before. They will then add efavirenz to their regimen and had~     bloods drawn again after another 1 or 2 weeks.~      Patients in the nelfinavir group took abacavir, amprenavir and nelfinavir for one week and~     then have blood sampling as described above for the ritonavir group. They will then add~     efavirenz to the regimen and repeat the blood tests again after another 1 or 2 weeks.~      Participants are being seen in the clinic for follow-up only if they wish to continue to~     participate and if the regimen appears to offer clinical benefit.~   "
274492|NCT00001765|"~     This study will investigate the safety and effectiveness of a modified stem cell transplant~     procedure for treating chronic granulomatous disease (CGD) in patients with active infection.~     CGD is an inherited disorder of neutrophils-a type of infection-fighting white blood~     cell-that leaves patients vulnerable to life-threatening infections. Transplantation of~     donated stem cells (cells produced by the bone marrow that mature into the different blood~     components-white cells, red cells and platelets) can cure CGD. However, this procedure~     carries a significant risk of death, particularly in patients with active infection, because~     it requires completely suppressing the immune system with high-dose chemotherapy and~     radiation. In addition, lymphocytes-another type of infection-fighting white blood cell-from~     the donor may cause what is called graft vs. host disease (GvHD), in which the donor cells~     recognize the patient's cells as foreign and mount an immune response to destroy them. To try~     to reduce these risks, patients in this study will be given low-dose chemotherapy and no~     radiation, a regimen that is easier for the body to tolerate and involves a shorter period of~     complete immune suppression. Also, the donor's lymphocytes will be removed from the rest of~     the stem cells to be transplanted, reducing the risk of GvHD.~      Patients with CGD between the ages of age 1 and 55 years old who do not have an active~     infection and who have a family member that is a well matched donor may be eligible for this~     study. Candidates will have a medical history, physical examination and blood tests, lung and~     heart function tests, X-rays of the chest and sinuses, and dental and eye examinations. A~     bone marrow sample may be taken to evaluate disease status. This test, done under a local~     anesthetic, uses a special needle to draw bone marrow from the hipbone.~      Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF~     will be injected under the skin for several days to increase stem cell production. Then, the~     stem cells will be collected by apheresis. In this procedure the blood is drawn through a~     needle placed in one arm, pumped into a machine where the desired cells are separated out and~     removed, and then the rest of the blood is returned through a needle in the other arm.~      A large plastic tube (central venous line) is placed into a major vein. It can stay in the~     body and be used the entire treatment period to deliver the donated stem cells, give~     chemotherapy or other medications, including antibiotics and blood transfusions, if needed,~     and withdraw blood samples. Several days before the transplant procedure, patients will start~     low-dose chemotherapy with cyclophosphamide and fludarabine, two commonly used anti-cancer~     drugs. They will also be given anti-thymocyte globulin to prevent rejection of the donated~     cells. When this conditioning therapy is completed, the stem cells will be infused through~     the central line. Patients will be given cyclosporine by mouth or by vein from 4 days before~     until 3 months after the stem cell transplant to help prevent rejection.~      The average hospital stay for stem cell transplant is 30 days. After discharge, patients will~     return for follow-up clinic visits weekly or twice weekly for 4 months. These visits will~     include a symptom check, physical examination, and blood tests. Blood transfusions will be~     given if needed. Subsequent visits will be scheduled at 4, 6, 12, 18, 24, 30 and 36 months~     after the transplant or more often if required, and then yearly.~   "
275380|NCT00000273|"~     The purpose of this study is to evaluate the effects of treatment medications (methadone,~     buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and~     smoked heroin self-administration.~   "
274493|NCT00001764|"~     This study will examine the safety and effectiveness of the drug mycophenolate mofetil (MPM)~     in treating Wegener's granulomatosis and related inflammatory vessel diseases. Blood vessel~     inflammation in these patients may involve different parts of the body, including the brain,~     nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart, and other~     sites. The more severe the involvement, the more likely the disease will be life-threatening.~     Standard treatment consists of combination drug therapy with prednisone and a cytotoxic~     agent-usually cyclophosphamide or methotrexate. However, some patients in whom this treatment~     is initially successful have a disease relapse; other patients cannot take the medications~     because of other health problems or because of severe side effects of the drugs.~      MPM is approved by the Food and Drug Administration to prevent kidney transplant rejection.~     It is chemically similar to another cytotoxic drug called azathioprine, which has been~     beneficial in maintaining remission in patients with Wegener's granulomatosis who have been~     treated successfully with cyclophosphamide. Because MPM is more effective than azathioprine~     in preventing organ rejection, it may also prove beneficial as a second-line treatment for~     Wegener's granulomatosis.~      Patients with Wegener's granulomatosis or related inflammatory vessel diseases who have had a~     relapse following treatment with cyclophosphamide and methotrexate or who cannot take one or~     both of these drugs may be eligible for this study. Only patients who have been treated at~     NIH in the methotrexate protocol or the cyclophosphamide switching to methotrexate protocol,~     or who have received the exact same treatment from their own physician may participate.~      Participants will have a complete medical evaluation including laboratory studies.~     Consultations, X-rays and biopsies of affected organs may also be done if indicated for~     diagnosis or treatment. Patients with active disease will be given MPM and prednisone, both~     in tablet form. Patients with inactive disease will receive only prednisone if they are~     already taking it. In both cases, the prednisone will be reduced gradually and discontinued~     if the disease improves significantly. MPM therapy will continue for at least 2 years. If~     after 2 years the disease remains in remission, the MPM dose will be gradually reduced and~     then stopped. If active disease recurs while on MPM therapy, the treatment plan will likely~     be changed. The new regimen will be determined by the severity of disease, other medical~     conditions, and history of side effects to previous medications.~      Patients will be followed at the NIH clinic every month for the first 3 months on MPM and~     then every 3 months for another 18 months. Those whose disease has remained in remission and~     have stopped all medications will then be followed every 6 months for 4 visits. The follow-up~     visits will include a physical examination, blood draws, and, if needed, X-rays. Visits may~     be scheduled more frequently if medically indicated.~   "
274494|NCT00001762|"~     This study will examine risk factors for facial wasting and avascular necrosis (AVN, a type~     of damage to the hip and other bones) in HIV-infected patients. The prevalence and natural~     history of AVN are also being evaluated. This study will use magnetic resonance imaging (MRI)~     to identify and monitor these conditions in patients with and without diagnosed AVN and to~     identify risk factors.~      HIV-infected patients 18 years of age and older may be eligible for this study. HIV-infected~     children 4 years and older who can tolerate magnetic resonance imaging without sedation may~     also participate. Candidates may be screened for participation with a medical history,~     physical examination, blood and urine tests and possibly an electrocardiogram. Volunteers~     will provide a medical history and may have a brief physical examination. The study is~     currently closed to normal volunteers.~      HIV-infected patients will have a MRI scan of the hip bone, and possibly other bones. Before~     the scan, they will provide a medical history by interview or questionnaire and have a~     physical examination. Those with diagnosed AVN will also have blood drawn to help identify~     potential risk factors for AVN. For the MRI, the patient lies flat on a stretcher that is~     moved into a cylindrical machine with a strong magnetic field. Earplugs are worn to muffle~     thumping sounds produced by radio waves that form the images. Patients can speak with a staff~     member via an intercom system at all times during the procedure. Repeat MRI studies will be~     requested at approximately 3- to 12-month intervals for up to 5 years, to see if changes~     occur with time. If medically indicated, additional diagnostic studies may be done to obtain~     information needed for appropriate medical care. Blood will be drawn periodically to examine~     immune parameters and viral blood levels. Patients with AVN may have periodic consultations~     with the rehabilitation medicine service and orthopedic surgeons.~   "
274495|NCT00001760|"~     Cytokine Production Patterns in Patients with Systemic Mastocytosis Compared with Atopic~     Dermatitis and Healthy Individuals~      Summary: This study will examine how mast cells (cells involved in allergic reactions)~     migrate and multiply in the skin of patients with mastocytosis, a condition characterized by~     too many mast cells in the body. The mast cells tend to multiply in the skin, causing dark,~     itchy skin spots known as urticaria pigmentosa. This study will determine if the skin of~     patients with mastocytosis produces chemicals called cytokines that cause mast cells to~     migrate to the skin and multiply. The findings will be compared with those from normal~     volunteers and patients with atopic dermatitis, a skin disease characterized by recurrent~     itchy rash usually seen in people with a family history of allergies.~      Healthy volunteers, patients with mastocytosis and patients with atopic dermatitis 18 years~     of age and older may be eligible for this study. Participants will have the following tests~     and procedures:~        -  Suction blisters - Two to eight small blisters will be raised on the forearm using~          gentle suction. The fluid in the blisters will be collected with a syringe to study the~          chemicals produced by the skin. The tops of the blisters may be removed for research.~        -  Template study - Patients with high cytokine content in the blister fluid may have a~          template study. For this procedure, a plastic block (template) with holes matching the~          blister sites is placed over the blistered area. The wells of the template are filled~          with salt water and the fluid is removed with a syringe at 3, 8 and/or 24 hours.~          Patients are hospitalized for 24 hours for this study.~        -  Skin biopsy - A skin biopsy will be done to correlate cytokine levels with the number of~          mast cells in the skin. An area of skin is numbed with an anesthetic and a small~          circular area about the size of a pencil eraser is removed, using a sharp cookie~          cutter-type instrument.~        -  Blood draw - About 4 tablespoons of blood will be drawn to compare the chemicals in the~          blood with those in the blister fluid. The blood will also be analyzed for a complete~          blood count, clotting factors and substances that may be elevated in people with~          allergies.~   "
274496|NCT00001758|"~     This study will continue to treat and collect safety and efficacy data on patients who~     participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir,~     amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of~     Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects~     with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a~     Protease Inhibitor-Containing Regimen).~      HIV-infected patients 18 years of age and older who participated in the above study at the~     NIH site may be eligible for the current study. Participants will be followed every 3 months~     with a general health evaluation and laboratory tests. This is a NIH study, and information~     will not be provided to Glaxo Wellcome~   "
274497|NCT00001756|"~     This study will investigate mast cell precursors that circulate in the blood. In a group of~     diseases collectively known as mastocytosis, mast cells accumulate in abnormal amounts in the~     skin, lymphoid tissues, bone marrow, liver and spleen. Some forms of mastocytosis have a~     generally good prognosis; for others, the prognosis is poorer. There is no known cure for any~     form of the disease. A better understanding of mast cells and how they respond to certain~     substances may provide insights that will lead to effective treatments for mastocytosis.~      Patients with systemic mastocytosis and normal healthy volunteers between the ages of 20 and~     60 may be eligible for this 8-day study. Participants will undergo the following procedures:~        -  Day 1 Medical history, physical examination, and blood tests to assess general health~          status~        -  Days 2 through 6 Daily injections under the skin of G-CSF a hormone that stimulates~          white blood cell production~        -  Day 7 Leukapheresis a procedure for collecting large numbers of white blood cells. In~          leukapheresis, blood is drawn through a needle placed in an arm and channeled into a~          cell separator machine. The white cells are collected and the rest of the blood is~          returned to the body through a needle in the other arm. The procedure takes up to 3~          hours.~        -  Days 7 and 8 Blood draw (about 1 teaspoon) to monitor white blood cell counts.~   "
274687|NCT00001366|"~     Researchers are interested in studying if magnetic resonance imaging (MRI) is practical for~     locating the areas of the brain associated with language in children with epilepsy.~      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar~     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and~     water. Blood carries fuel to the brain and waste products away from the brain. As brain~     activity increases blood flow to and from the area of activity increases also.~      Patients participating in the study will be asked to perform tasks designed to test language~     skills while undergoing an MRI to detect areas of the brain using oxygen and receiving blood~     flow.~   "
274498|NCT00001750|"~     Some drugs have the ability to push stem cells (the cells responsible for producing new cell~     types) out of the bone marrow and into the blood stream. The steps involved in this process~     are still poorly understood. However, a better understanding of this process could lead to~     improved results in transplantation, cancer treatment, and contribute to the development of~     new genetic therapies for a wide variety of disorders.~      In this study researchers plan to compare two different treatments, both that mobilize (push)~     stem cells out of the bone marrow into the blood stream. In addition, researchers will~     attempt to determine which is the most efficient at mobilizing blood cells of patients with~     multiple myeloma.~      Information and knowledge gained from this study will help to design future transplantation~     and genetic therapy research studies.~   "
274499|NCT00001749|"~     Diamond Blackfan anemia (DBA) is a condition in which the bone marrow is underdeveloped. DBA~     is considered a congenital disease, meaning patients are born with it. In DBA there is a lack~     of cells that give rise to red blood cells. The other elements produced in the bone marrow,~     such as white blood cells and platelets, are normal.~      Standard treatments used for this disorder such as steroids and bone marrow transplants are~     associated with failure, relapse, side-effects, increased morbidity, and even death. Two~     drugs, antithymocyte globulin (ATG) and cyclosporin have been used to treat DBA, but have~     only provided occasional responses. No study has ever combined these two drugs for the~     treatment of DBA.~      This study is designed to explore the combined use of ATG and cyclosporine as a rational~     approach to the treatment of DBA.~   "
274500|NCT00001746|"~     Genetically inherited heart diseases like hypertrophic cardiomyopathy (HCM) are conditions~     affecting the heart passed on to family members by abnormalities in genetic information.~     These conditions are responsible for many heart related deaths and illnesses.~      Presently, there are several research studies being conducted in order to improve the~     understanding of disease processes and symptoms associated with genetically inherited heart~     diseases.~      This study is designed to determine the eligibility of patients diagnosed with or suspected~     to have inherited heart disease to participate in these research studies.~   "
274501|NCT00001741|"~     The renin angiotensin system is a complex process involving hormones and enzymes that~     regulate blood volume and blood pressure. The hormone angiotensin II is responsible for~     making blood vessels narrow or constrict. Angiotensin II is found in the blood and can attach~     to special sites called receptors on blood vessel walls. These receptors are programmed to~     accept angiotensin II and cause a constriction of the blood vessel. This function is found in~     the genetic information of each individual person.~      Occasionally patients have changes in their genes related to angiotensin II receptors. These~     changes may result in the receptors acting differently to angiotensin II, which may affect~     the function of blood vessels.~      This study is designed to improve researchers understanding of the physiological effects on~     blood vessels associated with mutations of the genes responsible for angiotensin II receptor~     function.~   "
274502|NCT00001737|"~     This study will evaluate the safety and effectiveness of a sustained-release cyclosporin~     implant to treat uveitis, a sight-threatening eye inflammation caused by an immune system~     abnormality. Previous studies in humans have shown that, taken by mouth, the drug cyclosporin~     is effective in treating chronic uveitis.~      Uveitis may require long-term treatment with potent immune-suppressing drugs, such as~     cyclosporin, cyclophosphamide, methotrexate, azathioprine or steroids. Taken systemically (by~     mouth or injection), however, these drugs can do serious damage to the kidneys, liver or~     lungs, and can raise blood pressure and lower blood cell counts. Because of this, some~     patients cannot or will not use these medicines.~      This small pilot study will evaluate the safety, and to some extent effectiveness, of~     cyclosporin delivered directly into the eye, to try to prevent harmful side effects. In~     animal studies, sustained-release cyclosporin implants did not cause the severe side effects~     seen with systemic use of the drug. Some animals developed opacity of the lens and slowed~     retinal responses, both of which reversed when the drug was stopped. Earlier animal studies~     of cyclosporin injected directly into the eye reduced inflammation that had been produced~     experimentally.~      Patients with uveitis who have active inflammation and poor vision are eligible to~     participate in this study. Patients will be randomly assigned to one of two treatment groups.~     One group will receive a 1-mg implant that releases 0.8 micrograms of drug each day; the~     second group will receive a 2-mg implant that delivers 1.4 micrograms of drug a day.~      Before surgery, patients will have a medical history, basic physical examination, and~     complete eye examination, including special tests called electroretinogram and fluorescein~     angiography. An electroretinogram measures the electrical responses generated in the retina~     in the back of the eye. Fluorescein angiography uses a special camera to photograph the~     retina, showing the condition of the blood vessels in the eye.~      The surgical procedure to place the implant takes about 1.5 hours and may be done under~     either local or general anesthesia. Patients will stay in the hospital overnight. After~     discharge from the hospital, they will return for follow-up visits 1 and 2 weeks after~     surgery, then once a month for 6 months, and then every 3 months until the implant is~     depleted of drug or removed. During these follow-up visits, eye examinations will be repeated~     to evaluate the effects of the implant on the eye. Repeat blood tests will measure the amount~     of cyclosporin in the blood and the drug's effect on the kidneys. When the implant runs out~     of drug (between 2 and 3 years), it may be removed or left in place.~   "
274503|NCT00001734|"~     This screening protocol is designed to facilitate patient recruitment to National Eye~     Institute (NEI) clinical research studies. Patients must meet specific requirements of a~     research study; this protocol serves as a first step for admitting patients to an appropriate~     program.~      Candidates may have a diagnosed or undiagnosed eye condition. They will be screened with a~     medical history, physical examination, eye examination and blood test. Other screening~     procedures may include routine laboratory tests, non-invasive imaging, and questionnaires.~     The eye examination includes measurement of eye pressure and dilation of the pupils to fully~     examine the lens, vitreous and retina. Specialized eye tests will be done only if needed to~     determine eligibility for a specific study. When the screening is completed, patients will be~     informed of their options to participate in a study. Patients who are found ineligible for a~     current study will be informed of alternative treatments or options. No treatment is offered~     under this protocol.~   "
274504|NCT00001733|"~     This screening protocol is designed to help recruit patients for National Eye Institute (NEI)~     studies of the retina, such as diabetic retinopathy and macular degeneration. Patients must~     meet the specific criteria of a research study, and this protocol serves as a first step for~     admitting patients to a retinal disease study.~      Candidates will undergo a medical history and comprehensive eye examination. The eye~     examination includes dilation of the pupils to fully examine the retina. In some studies,~     photographs of the eye are required. This is done using fluorescein angiography. In this~     procedure, a dye called sodium fluorescein is injected into the blood stream through a vein.~     After the dye reaches the blood vessels of the eye, photographs are taken of the retina.~     Other diagnostic procedures may include physical examination, questionnaires, routine~     laboratory tests and other standard or specialized tests, as needed.~      When the screening is completed, patients will be informed of their options to participate in~     a study. Patients who are ineligible for a current study will be informed of alternative~     treatments or options. No treatment is offered under this protocol.~   "
274505|NCT00001732|"~     This screening protocol is designed to help recruit patients for National Eye Institute (NEI)~     studies on inherited eye diseases. Patients must meet specific requirements of a research~     study, and this protocol serves as a first step for admitting patients to an appropriate~     program.~      Candidates will undergo a medical history, physical examination, eye examination and blood~     test. The eye examination includes measurement of eye pressure and dilation of the pupils to~     fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to~     determine eligibility for a specific study in NEI's Ophthalmic Genetics Clinic. These include~     routine laboratory tests, non-invasive imaging, questionnaires and other standard tests, as~     well as specialized tests and procedures where needed, including genetic testing. Photographs~     of the eye may be taken. Patients will be asked questions about family history, especially~     relating to eye disease or cataracts, and a family tree will be drawn. A blood sample will~     also be drawn.~      When the screening is completed, patients will be informed of their options to participate in~     a study. Patients who are ineligible for a current study will be informed of alternative~     treatments or options. No treatment is offered under this protocol.~   "
274506|NCT00001729|"~     Hepatitis C is a major cause of liver disease in the United States and leads to cirrhosis of~     the liver in approximately one-third of patients some of whom will ultimately suffer from~     liver failure or liver cancer. At present, the recommended therapy of hepatitis C is the~     combination of alpha interferon and ribavirin given for 6 to 12 months. Ribavirin is a~     antiviral drug that is given by mouth. Interferon is both an antiviral and an immune~     medication which must be given by injections (three times a week) and has many difficult side~     effects. The purpose of this study is to determine whether the combination of ribavirin and~     interferon improve the liver disease of hepatitis C and whether improvements can be~     maintained by continuing ribavirin therapy long-term. This study will take 100 to 120~     patients suffering from hepatitis C and place them under combination drug therapy with alpha~     interferon and ribavirin. The course of drug therapy is scheduled to last 6 to 12 months.~     Patients will be selected after appropriate screening for hepatitis C virus and elevated~     liver enzymes are conducted and liver biopsy shows chronic hepatitis with some degree of~     injury and scarring.~      During the first 6 months of the study, subjects will be asked to return to the outpatient~     clinic for routine check-ups and blood tests every 2 to 4 weeks. Blood tests will include~     tests for hepatitis C virus. If the virus test becomes negative on treatment, the therapy~     will be considered successful and will be continued for a full 6 or 12 months (depending upon~     the strain of virus).~      If the virus test does not become negative during the first six months of treatment, subjects~     will be considered non-responders and will stop taking interferon but will continue on~     ribavirin alone or an identically appearing placebo tablet. These non-responsive subjects~     will continue this therapy for an additional 12 months. (A year-and-a-half total).~      Upon completion of the drug therapies, subjects will be requested to submit blood samples and~     undergo a liver biopsy to determine if the therapy was successful. Test results that reveal a~     loss of hepatitis C antibodies or normal levels of liver enzymes will be deemed successful.~      Patients that have successful laboratory test results will be considered for continuation of~     ribavirin therapy. Patients that received placebo for a year will be eligible to receive~     ribavirin long-term at the end of the study.~   "
274507|NCT00001728|"~     This study will evaluate the effectiveness of alendronate in treating the bone abnormality in~     polyostotic fibrous dysplasia and McCune-Albright syndrome. In these diseases, areas of~     normal bone are replaced with a fibrous growth similar to a scar. The weakened bone causes~     pain and increases patients' risk of bone fractures and bone deformities. Alendronate belongs~     to a class of drugs called bisphosphonates, which are approved by the Food and Drug~     Administration to treat bone weakening, deformity and pain in other medical conditions. It is~     thought that bisphosphonates might work by slowing the activity of osteoclasts-cells that~     break down bone.~      Patients 12 years of age and older with polyostotic fibrous dysplasia or McCune-Albright~     syndrome may be eligible for this 3-year study. Candidates must also be enrolled in NIDCR's~     protocol 98-D-0145 (Screening and Natural History of Patients with Polyostotic Fibrous~     Dysplasia and McCune-Albright Syndrome).~      Participants will be randomly assigned to one of two treatment groups: they will take one~     capsule a day of either alendronate or placebo (a look-alike capsule that has no active~     ingredient). They will take the capsules for 6 months, stop for 6 months, then take them for~     another 6 months and then go off them for 6 months. They will then remain off the drug or~     placebo for an additional 12 months and complete the study with a final follow-up visit at 36~     months. While taking alendronate or placebo, patients will also take calcium and vitamin D to~     prevent secondary hyperparathyroidism-a side effect of alendronate in which the bone does not~     release enough calcium.~      Patients will come to NIH for a physical examination and blood and urine tests every 6 months~     and for monitoring of their bone disease, vision, hearing, pain levels, functional~     evaluation, and photographs every 12 months. Many of the monitoring procedures, including~     imaging studies and biopsies, are performed for the screening protocol (98-D-0145) and will~     not be duplicated for this study. During the study periods when patients are taking~     alendronate or placebo, they will have blood samples drawn by their local physician once~     every 3 months and sent to NIH to check for secondary hyperparathyroidism.~      If at the end of the study alendronate is found to be effective, patients who were in the~     placebo treatment group will be offered alendronate for a 24-month period.~   "
274508|NCT00001727|"~     Polyostotic fibrous dysplasia (PFD) is a sporadic disorder which affects multiple sites in~     the skeleton. The bone at these sites is rapidly resorbed and replaced by abnormal fibrous~     tissue or mechanically abnormal bone. PFD may occur alone or as part of the McCune-Albright~     Syndrome (MAS), a syndrome originally defined by the triad of PFD, cafe-au-lait pigmentation~     of the skin, and precocious puberty. The bony lesions are frequently disfiguring and painful,~     and depending on the location of the lesion, can cause significant morbidity. Lesions in~     weight-bearing bones can lead to disabling fractures, while lesions in the skull can lead to~     compression of vital structures such as cranial nerves.~      The natural history of this disease is poorly described and there are no clearly-defined~     systemic therapies for the bone disease. The purpose of this study is to define the natural~     history of the disease with or without treatment.~   "
274509|NCT00001726|"~     This study will examine the composition of dental plaque-a naturally occurring substance that~     sticks to the teeth and can cause tooth decay and gum disease. A better understanding of how~     plaque builds up in the mouth may help in developing improved ways of controlling it.~      Healthy normal volunteers between the ages of 18 and 65 who work at the National Institutes~     of Health main campus in Bethesda, Maryland, may participate in this study. Candidates will~     be screened for eligibility with a medical and dental history.~      This study involves a maximum of five visits to the dental clinic. At the first visit,~     participants will have a dental examination, and a mold will be made of the mouth. To make~     the mold, a small plastic tray containing impression material will be placed in the~     volunteer's mouth and held in place for about 2 minutes to set. The tray will then be removed~     and a mold will be made from the impression. The mold will be used to make the mouthpiece~     used in study 1, described below, and the tooth fittings used in study 2, also described~     below. Volunteers will participate in one of these two studies.~      Study 1. Volunteers in study 1 will have their mouthpiece checked at the second visit, have a~     teeth cleaning, and have the mold put in place. The mouthpiece will be worn for up to 8~     hours, during which time soft foods can be eaten. Mouthwash should not be used while the~     device is in place. At the volunteer's third (last) visit, the mouthpiece will be removed and~     the volunteer will spit into a tube to collect saliva for examination for bacteria.~      Study 2. Volunteers in study 2 will have their teeth cleaned at the second visit and the~     tooth fittings placed onto the back teeth with a dental adhesive. The fittings will be worn~     for up to 72 hours, during which time volunteers can eat a regular diet and brush their~     teeth. Mouthwash should not be used while the fittings are in place. At the third, fourth and~     fifth visits, some of the fittings will be removed and, if necessary, the tooth surface will~     be polished. The last of the fittings will be removed at the fifth visit and the volunteer~     will spit into a tube to collect saliva for examination for bacteria.~   "
274538|NCT00001661|"~     The purpose of this study is to investigate the physiology associated with plasticity of the~     motor system. Plasticity refers to the process by which neighboring brain cells assume the~     responsibilities of damaged or diseased brain cells.~      The mechanisms behind this process are unknown. However, researchers have several theories~     about how plastic changes take place. Possible explanations include the growth of new~     connections between brain cells and the use of previously unused connections.~      Researchers plan to use transcranial magnetic stimulation and drug intervention in order to~     determine the mechanisms responsible for specific types of plasticity.~      Previous studies have shown that certain drugs can affect the mechanisms involved in these~     changes. By using one drug at a time, researchers plan to evaluate the role of each of~     several different mechanisms in brain reorganization.~   "
274510|NCT00001725|"~     This study will evaluate the safety and effectiveness of two drugs-dextromethorphan and~     topiramate-in treating orofacial (mouth and face) pain. Dextromethorphan, a commonly used~     cough suppressant, and topiramate, an anti-seizure medicine, block certain receptors on brain~     and spinal nerve cells that may cause the cells to produce electrical discharges and pain.~      Patients 18 years of age and older with oral and facial pain with trigeminal nerve damage and~     who have had pain daily for at least 3 months may be eligible for this study. Candidates will~     be screened with a medical history, physical examination, blood tests and psychiatric~     evaluation. These results will serve as baseline values for participants. Those enrolled in~     the study will take either dextromethorphan or topiramate in a 2-part study as follows:~      Dextromethorphan~      In Part 1, patients will take dextromethorphan and lorazepam (a commonly used anti-anxiety~     drug) separately in two 6-week periods. (Lorazepam is used in this study as an active~     placebo for comparison with dextromethorphan. An active placebo is a drug that does not work~     for the problem being studied but whose side effects are like those of the test drug.) They~     will take dextromethorphan for 4 weeks to determine the maximum tolerated dose (the highest~     dose that does not cause troubling side effects) and will stay on that dose for the remaining~     2 weeks. Then they will repeat this process with lorazepam. Patients who respond to either~     drug may continue with Part 2 of the study, which compares these two drugs four more times to~     confirm the response seen in Part 1. In Part 2, the maximum tolerated dose will be determined~     in a 2-week period and that dose will be continued for another 2 weeks. This procedure will~     be repeated eight times. Throughout the study, patients will keep a daily pain diary. They~     will be contacted by telephone 2 to 3 times a week during dose escalation to check for side~     effects. At the end of each of the two 6-week periods in Part 1 and at the end of each 4-week~     period in Part 2 of the study, patients will have a 1-hour clinic visit. Participants who~     live more than a few hours' drive from NIH will have a full telephone follow-up evaluation~     instead of the clinic visits.~      Topiramate~      Patients who receive topiramate will follow a plan similar to that described above for~     dextromethorphan, with the following exceptions. They will take topiramate and an inactive~     placebo (a look-alike pill that has no active ingredients) in two separate 12-week periods.~     Patients' maximum tolerated dose will be determined in the first 8 weeks and they will stay~     on that dose for the remaining 4 weeks of each period. Patients who respond to the medication~     in Part 1 may continue with Part 2 to confirm the response. Part 2 consists of six 6-week~     periods. The first 4 weeks of each will be used to determine the maximum tolerated dose and~     the patient will remain on that dose for the next 2 weeks. Patients will keep a daily pain~     diary and will be contacted by phone 2 to 3 times a week while doses are being increased.~     Patients who complete Part 2 of the topiramate study may participate in another phase of the~     study that will last for 2 years. Those who continue for this phase will take topiramate for~     the 2-year period. They will be followed regularly by a study nurse and will come to NIH~     every 6 months for a follow-up visit.~   "
274511|NCT00001724|"~     This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug~     flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery.~     Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain.~      Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be~     eligible for this study.~      Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery,~     they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and~     a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At~     the time of surgery, patients will also be given flurbiprofen or a placebo formulation~     (look-alike substance with no active ingredient) directly into the extraction site and a~     capsule that also may contain flurbiprofen or placebo. One in seven patients will receive~     only placebo.~      All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for~     observation of bleeding and medication side effects. Patients who do not have satisfactory~     pain relief from the test medicine after surgery may request a standard pain reliever. A~     small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1,~     2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of~     33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the~     day of surgery will be drawn from the catheter used to administer the sedative; the 24- and~     48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be~     collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.~   "
274512|NCT00001723|"~     Obesity is a condition affecting one-third off the U.S. population and is a major risk actor~     for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the~     blood), hypertension (high blood pressure), and other disorders of the heart and lungs.~     Individuals with the onset of obesity during childhood or adolescence are at an increased~     risk of obesity-related, diseases, both during adolescence and later in adult life.~      African American girls and women are at an increased risk for obesity, and have substantial~     rates of obesity-related diseases and causes of death. Further, many African American adult~     women fail to respond to many of the therapeutic approaches used to treat obesity. At present~     there are no medical therapies proven effective for the correction of severe obesity in~     children or adolescents.~      One medication that may have a favorable risk-benefit ratio in pediatric populations is~     Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in~     the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten~     in the diet. Xenical appears to be effective for reducing weight and obesity-associated~     diseases in obese adults.~      Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17~     year old severely obese African American and Caucasian children and adolescents who have one~     or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic~     steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).~   "
274513|NCT00001722|"~     Leptin is a hormone that acts in the body as a chemical messenger. It is produced in fat~     cells and is believed to regulate body weight in humans. Leptin decreases appetite and~     influences the energy balance of the body.~      This study will attempt to measure levels of leptin production in the fat pad of the body by~     using a process called microperfusion. Microperfusion works by inserting 2 to 3 probes (thin~     tubes) into the fat pad around the belly button. These probes can measure chemicals in an~     area known as the extracellular space. This is the small space between cells and blood~     vessels that hormones, medicines, nutrients, and salts travel through.~      The study will investigate the effects of a meal, insulin, glucose (sugar), and the~     medication isoproterenol on leptin levels. Researchers believe that leptin levels are~     regulated along with the enzyme, hormone sensitive lipase (HSL). When hormone sensitive~     lipase is activated fat is broken down in a process called lipolysis. In addition, increased~     levels of HSL result in decreased levels of leptin, which in turn increases appetite and food~     intake.~   "
274589|NCT00001574|"~     Brain tumors represent the most common solid tumor of childhood. Treatment generally entails~     surgery and radiation, but local recurrence is frequent. Chemotherapy is often used in an~     adjuvant setting, to delay radiation therapy or for resistant disease. Children with brain~     tumors are generally followed by imaging studies, such as CT or MRI. Difficulty arises in~     trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation~     injury. Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive~     method of detecting and measuring cellular metabolites in vivo. NMRS imaging complements~     routine MRI by giving chemical information in conjunction with spatial information obtained~     by MRI.~      This study will be conducted to determine NMRS imaging patterns before, during and after~     chemotherapy in pediatric patients with primary or metastatic brain tumors in an attempt to~     identify and characterize specific patterns of metabolites related to tumor regrowth, tumor~     response to therapy, edema or necrosis.~   "
274514|NCT00001721|"~     Smith-Lemli-Opitz Syndrome (SLOS) is a genetic disorder (autosomal recessive) caused by an~     abnormality in the production of cholesterol. The disorder can occur in both a mild or~     severe form. SLOS is associated with multiple birth defects and mental retardation. Some of~     the birth defects include; abnormal facial features, poor muscle tone, poor growth, shortened~     life span, and abnormalities of the heart, lungs, brain, gastrointestinal tract, limbs,~     genitalia, and kidneys.~      There is no known cure for SLOS but recently patients have been treated with increased~     amounts of cholesterol in their diet. The cholesterol in a persons diet is unable to correct~     the abnormalities in the patient's organs, but researchers hope it will improve growth~     failure and mental retardation.~      This study was developed to answer questions about the causes and complications of SLOS, as~     well as the effectiveness of cholesterol treatment. The study will enroll patients diagnosed~     with SLOS, and their mothers. The objectives of the study will be to address the following~     questions:~        1. <TAB> What is the prognosis / natural history of the demyelination in the nervous system~          of patients with SLOS?~        2. <TAB> Do patients with SLOS have other problems concerning the function of their~          endocrine systems?~        3. <TAB>What are the genetic make-ups of patients with SLOS?~        4. <TAB>Can further studies of cholesterol metabolism and genetic testing, using SLOS~          fibroblasts, increase the understanding of SLOS?<TAB>...~   "
274515|NCT00001720|"~     Bones grow and stay strong through a continuous process of formation (building) and~     resorption (break down). When more bone is formed than resorbed, the density (level of~     calcium) in bone increases and the bones become stronger. However, if more bone is resorbed~     than formed the density of bone decreases and the bones become weak. This condition is called~     osteoporosis.~      Osteoporosis is a rare but serious condition in children. Childhood osteoporosis can occur~     without a known cause (idiopathic juvenile osteoporosis). Children with osteoporosis suffer~     from pain, inability to stay active, and increased amounts of broken bones, including~     fractures of the spine. Even mild childhood osteoporosis may have long-term consequences~     since individuals who achieve a less than normal bone composition (peak bone mass) during the~     first 20-30 years of life may be at an increased risk for osteoporosis as adults.~      Alendronate (Fosamax) is a drug that works by stopping bone resorption (break down). It has~     been used to treat post-menopausal osteoporosis, male osteoporosis and adults with~     osteoporosis due to long-term steroid therapy. The goal of this study is to determine the~     effectiveness of alendronate in children with idiopathic juvenile osteoporosis. Researchers~     believe that children treated with alendronate will improve bone strength and decrease the~     amount of fractures caused by osteoporosis.~   "
274516|NCT00001719|"~     This study will use magnetic resonance imaging (MRI) to examine blood flow patterns in the~     arteries and veins of the liver and abdomen. It will 1) determine the best way to measure~     blood flow in these vessels, and 2) make detailed measurements of the blood flow patterns of~     these vessels. Information about normal liver blood flow may help explain the role of blood~     flow in liver disease.~      Normal healthy volunteers 18 years of age and older may be eligible for this study. They will~     undergo MRI-a diagnostic tool that uses a strong magnetic field and radio waves to show~     structural and chemical changes in tissue and the speed of moving blood. The patient lies on~     a stretcher inside a metal cylinder (the scanner) for 1 to 1.5 hours and will be required to~     lie very still for 10 to 15 minutes at a time. Blood pressure, heart rate, breathing and the~     amount of oxygen in the fingertip are measured during the scan.~   "
274517|NCT00001716|"~     Sickle cell anemia is the most common genetic disease affecting African-Americans. About 1 in~     every 1000 African-Americans has the disease and 1 in every 12 carry the genes that could be~     passed on to their children. People with sickle cell anemia have abnormal hemoglobin, the~     molecules responsible for carrying oxygen in the blood. The abnormal hemoglobin can cause~     damage to the red blood cells. The damaged red blood cell may then stick in the blood vessels~     and cause pain and injury to organs. Some of the complications caused by the sticking of~     blood cells are called acute pain crisis and acute chest syndrome (ACS).~      Nitric oxide (NO) is a gas that has been proposed as a possible therapy for the ACS~     complication of sickle cell anemia. Studies have shown that NO may favorably affect sickle~     cell hemoglobin molecules, thereby improving blood flow through small vessels.~      This study is designed to evaluate the effects of NO, when taken in combination with a drug~     called nitroglycerin on patients with sickle cell anemia and normal volunteers. The effects~     of these two drugs only last while the patient is receiving them. Researchers hope the~     information learned from this study will help to develop new therapies for sickle cell~     anemia.~   "
274518|NCT00001715|"~     The Hematology Service provides hematology consultations for patients at the Clinical Center~     and participates in the training of hematology fellows. Patients with a broad range of~     hematologic disorders must be available in order for the senior staff of the Service to~     maintain clinical expertise and to provide the breadth of experience necessary for the~     fellowship program. The purpose of this protocol is to meet these needs by allowing the~     Hematology Service to see patients with a spectrum of hematologic diseases not studied on~     existing research protocols at the NIH. These patients will be evaluated over the course of~     several outpatient visits and returned to the care of their referring physicians.This study~     was developed to evaluate and possibly treat patients with blood disorders. The Hematology~     Service of the National Institutes of Health is responsible for the care of patients~     participating in research studies. In addition the Hematology Service also provides~     consultation for small groups of patients with blood disorders that have not been diagnosed~     or that may need special testing.~      This study will also provide doctors at the NIH the opportunity to learn more about a wide~     range of blood disorders and conditions. Patients participating in this study will be~     evaluated over the course of several outpatient visits and will continue to be cared for by~     their regular physician.~   "
274590|NCT00001572|"~     Patients undergo chemotherapy until remission is obtained, or disease has been stable for two~     cycles of chemotherapy, or progressive disease develops.~      Three to six months after completion of chemotherapy, patients who have achieved complete~     clinical remission or minimal disease status receive a series of 5 injections (given 1-2~     months apart) of a vaccine consisting of 0.5 mg autologous tumor-derived immunoglobulin (Id)~     conjugated to KLH. The vaccine is administered with subcutaneous QS-21 as an immunological~     adjuvant....~   "
275381|NCT00000271|"~     The purpose of this study is to measure the effect of desipramine in cocaine abusers selected~     for major depression or dysthymia.~   "
274519|NCT00001713|"~     Acute deep venous thrombosis (ADVT) of the lower extremity is a common disorder. Traditional~     treatment with anticoagulation therapy is effective in reducing the associated risk of~     pulmonary embolism, but is ineffective in restoring patency of the venous system of the lower~     extremity. While systemic thrombolytic therapy has been shown to be more effective than~     anticoagulation, catheter directed local thrombolytic therapy is the most effective treatment~     in restoring venous patency. Current treatment regimens are based on use of urokinase,~     infused continuously through catheters imbedded into the thrombus. These treatment regimens~     require doses on the order of 10,000,000 units of urokinase, resulting in significant~     bleeding complications and prohibitive costs.~      Experience at NIH with pulse-spray treatment of axillary subclavian venous thrombosis with~     rtPA indicates that this is a highly effective and safe alternative thrombolytic regimen. The~     proposed protocol is designed to evaluate the efficiency, safety, and doses of rtPA~     associated with pulse spray directed rtPA treatment of the more extensive venous thrombosis~     encountered in the lower extremity.~   "
274520|NCT00001712|"~     Following guidelines issued by the Centers for Disease Control, the Clinical Center~     implemented a Universal Precautions policy in November 1987 in an attempt to reduce~     healthcare workers' risks for occupational exposures to bloodborne pathogens. All hospital~     personnel whose jobs entailed potential exposure to patients' blood and body substances were~     required to attend a training session and complete a written examination. Based on data from~     surveys conducted before and twelve months after training in Universal Precautions, the~     frequency of cutaneous exposure to blood decreased by 50% in temporal association with~     implementation of Universal Precautions. Staff at the Clinical Center are required to take a~     refresher course in Universal Precautions annually.~      The prevalence of bloodborne infections is high in Japan; however, Universal Precautions are~     not widely practiced in Japan. This study is designed: 1) to evaluate and compare nurses'~     knowledge of the epidemiology, pathogenesis, occupational risks, and appropriate prevention~     strategies for managing patients infected with bloodborne pathogens in the healthcare setting~     in seven university hospitals in Japan and at the Clinical Center of the National Institutes~     of Health in the US; 2) to compare self-reported levels of compliance with existing infection~     control recommendations designed to limit risk for exposure to bloodborne pathogens in all~     four institutions; 3) to compare self-reported frequencies of cutaneous exposures to blood at~     the four hospitals in the study; and 4) to evaluate the effect of educational intervention on~     nurses perceived compliance with recommendations and on the frequency of self-reported~     exposures to blood.~   "
274521|NCT00001711|"~     Magnetic resonance is an imaging technique that uses magnetic fields and radio waves to~     create images of the body. The technology used in magnetic resonance imaging continues to~     improve. Advancements in magnetic resonance imaging (MRI) requires researchers to study new~     techniques in normal volunteers in order to understand how to use them in patients with~     diseases.~      In this study researchers plan to do a variety of diagnostic tests including magnetic~     resonance imaging on normal volunteers. The studies may involve injections of contrast media,~     substances injected into the blood of participant that improves the image created by the MRI~     scanner. The study is not expected to benefit the participants. However, information gathered~     from the study may be used to improve diagnostic techniques and develop new research studies.~   "
274522|NCT00001703|"~     About 27,000 new cases of renal cell carcinoma (RCC) are diagnosed every year in the United~     States. 11,000 of these cases will die from the disease. More than half of patients present~     with advanced or metastatic disease for which chemotherapy plays a very limited role.~     Therefore, development of another therapeutic approach is needed. Cancers in humans are~     commonly associated with mutations in dominant and recessive oncogenes. These genes produce~     mutated proteins that are unique to cancer cells. Von Hipple-Lindau (VHL) gene which is~     associated with the development of the VHL disease, has been recently mapped and cloned, and~     it is found to be mutated in 57% of sporadic renal cell carcinomas.~      Data in mice have shown the generation of major histocompatibility complex (MHC) restricted~     cytotoxic T lymphocyte (CTL) that are capable of detecting endogenous cytoplasmic peptide~     derived from mutated oncogenes. In addition, we have recently demonstrated, by conducting~     different phase I clinical trials in which we vaccinate cancer patients with mutated Ras or~     p53 peptides corresponding to the abnormality patients harbor in their tumors, that in some~     patients we can generate immunological responses represented by the generation of lymphocytes~     (CD4+ and/or CD8+). In the current study, we would like to extend our observations to test~     whether VHL tumor suppressor protein can be immunologically targeted by vaccination. We have~     identified specific epitopes along the amino acid sequence of the VHL protein, which~     represent known specific human leukocyte antigen (HLA) class-I binding motifs. These amino~     acids stretches in the VHL protein correspond to the area of the point mutation hot spots.~     Therefore, we propose to treat patients with sporadic RCC who carry VHL mutations in their~     tumors with corresponding mutant VHL peptide vaccination. This vaccination will be done~     either by using pulsed-autologous peripheral mononuclear cells with the peptides, or peptides~     administered subcutaneously alone or in combination with cytokines.~   "
274523|NCT00001702|"~     Innate immunity plays an important role for fungal recognition and initiation of fungicidal~     activity. We hypothesize that subtle differences in different molecules of innate immunity~     may contribute to either the predisposition or clinical course of infection with~     Blastomycosis dermatitidis. To test this hypothesis, we propose to analyze the allelic~     frequencies of 15 different genes (mannose binding lectin, Fc-gamma receptor IIa and IIb,~     Fc-gamma receptors IIIa and IIIb, myeloperoxidase, tumor necrosis factor-alpha and -beta,~     interleukin 1A and 1B, interleukin-1 receptor antagonist, interleukin-10, NRAMP-1,~     chitotriosidase, and chemokine receptor 5) and their intragenic polymorphic forms and to~     compare this data to the incidence and severity of Blastomycosis dermatitidis infection. With~     this study we hope to identify a group of molecules of innate immunity which influence the~     risk and severity of invasive Blastomycosis dermatitidis infection.~   "
274524|NCT00001701|"~     Innate immunity plays an important role for fungal recognition and initiation of fungicidal~     activity. We hypothesize that subtle differences in different molecules of innate immunity~     may contribute to either the predisposition or clinical course of infection with Cryptococcus~     neoformans. To test this hypothesis, we propose to analyze the allelic frequencies of 15~     different genes (mannose binding lectin, Fc-gamma receptor IIa and IIb, Fc-gamma receptors~     IIIa and IIIb, myeloperoxidase, tumor necrosis factor-alpha and -beta, interleukin 1A and 1B,~     interleukin-1 receptor antagonist, interleukin-10, NRAMP-1, chitotriosidase, and chemokine~     receptor 5) and their intragenic polymorphic forms and to compare this data to the incidence~     and severity of C neoformans infection. With this study we hope to identify a group of~     molecules of innate immunity which influence the risk and severity of invasive C neoformans~     infection.~   "
275382|NCT00000270|"~     The purpose of this study is to define temporal profile of brain activation (rCBF) using~     Xenon-SPECT and O 15-PET.~   "
275383|NCT00000269|"~     The purpose of this study is to evaluate the safety and efficacy of pergolide for cocaine~     dependence.~   "
274525|NCT00001698|"~     In Phase II trials, treatment with ketorolac tromethamine oral rinse has been shown to block~     periodontal disease progression even in the absence of standard clinical intervention such as~     scaling and root planing which is routinely done to reduce the periodontal pathogen load that~     is driving the local destructive host inflammatory response. Resolution of periodontal~     disease has a favorable effect on normalizing the cellular and biochemical indices of~     inflammation as reflected by histological changes as well as the levels of prostaglandin E2~     (PGE2) and interleukin I beta (IL-1beta). In this trial, we will prospectively evaluate if~     eliminating the inflammatory process (via inhibition of PGE2 biosynthesis) in the oral cavity~     has a favorable impact on reversing oropharyngeal leukoplakia. To test this hypothesis, up to~     57 prospectively identified individuals with objective findings of oropharyngeal leukoplakia~     will be randomized to receive either a mouth rinse containing ketorolac or placebo. Ketorolac~     is a 7-fold selective inhibitor of cyclooxygenase-2 (Cox-2), which has been designed for~     local delivery to maximize the drug exposure to critical oral target tissues while minimizing~     gastric and systemic exposure to the drug. All responses will be determined at the three~     month completion of trial using the response criteria developed at MD Anderson Cancer Center.~     The drug will be given for three months and then all the patients will be followed for one~     additional month off all oral treatment to observe for late side effects. Based on the~     analysis of oral exam and photographically documented change in the pretreatment area of~     leukoplakia, the response of all patients will be determined.~      The evaluation of the outcome will include a measurable secondary endpoint consisting of an~     assessment of histological change as determined by serial punch biopsies of the oral cavity.~     In addition, a panel of carcinogenesis and inflammatory markers will be serially measured at~     baseline, at one month follow up or at study conclusion. In the residual tissue, other~     bioassays will be evaluated to determine their suitability as intermediate endpoint markers.~     The purpose of this study is a preliminary evaluation of the effectiveness of ketorolac as a~     potential chemoprevention agent for oropharyngeal cancer. If ketorolac administration in this~     preliminary Phase IIB trial is associated with reversal of leukoplakia, then a definitive~     Phase III chemoprevention trial with a cancer reduction endpoint (most likely in a~     cooperative group-type setting) may be the next validation step.~   "
274526|NCT00001695|"~     Simultaneous use of alternative or complementary medical therapies by cancer patients~     undergoing conventional medical treatment is extremely common and may not always be disclosed~     to the patient's treating physician. Cancer patients undergoing Phase I therapy on clinical~     trials constitute a special population of patients, since by definition, their prescribed~     therapy is scientifically unproven in terms of efficacy. Phase I patients are closely~     monitored for adverse effects in order to identify and characterize the toxicities and to~     define a tolerable dose of their experimental treatment. Thus, the unrecognized use of~     alternative therapies by patients actively enrolled in phase I trials may potentially~     confound rational drug development by causing adverse side effects or by contributing to drug~     interactions. Examples of clinical toxicities induced by alternative medical treatments~     include liver dysfunction or renal failure caused by herbal preparations, or hematologic~     abnormalities, such as eosinophilia-myalgia syndrome caused by tryptophan food supplements.~     Therefore, it is important to document and determine the prevalence of alternative therapy~     use in this specific patient population; however, this issue has not previously been examined~     in a scientifically rigorous manner. We propose to conduct a survey and interview study of~     phase I cancer patients enrolled in ongoing clinical trials at the National Cancer Institute~     to determine the prevalence of alternative therapy use in this population. This study will~     also examine patient attitudes and perceptions regarding their use of alternative therapy as~     compared with their scientifically-sanctioned phase I experimental therapy. This information~     has important implications for drug development.~   "
274527|NCT00001693|"~     This is a randomized, placebo-controlled Phase I/II multi-center trial, of the safety and~     efficacy of Celecoxib in a cohort of 81 HNPCC subjects and gene carriers. The three proposed~     intervention arms are: Celecoxib (to be provided by Searle) will be administered at 200mg~     p.o. BID x 12 months or 400mg p.o. BID x 12 months vs. Placebo p.o. BID x 12 months.~     Assessment of endoscopic and tissue-based biomarker endpoints will be conducted at baseline~     and 12 months on study drug or placebo. Patients that present with polyps at baseline will~     undergo a month 4 endoscopy. Plasma drug trough samples for pharmacokinetic analyses will be~     collected at baseline and month 12. NCI-Chemoprevention Branch will coordinate the efforts~     and activities of all sites.~      Safety monitoring will occur via in-patient interviews with exams at month twelve; symptom~     questionnaires completed at baseline, months one, four, eight and twelve; blood and~     urinalysis at baseline and at months one, four, eight and twelve. A post-administration~     telephone call to evaluate side effect resolution will occur at months 13-14 for patients who~     have unresolved adverse events at the end of month 12.~   "
274528|NCT00001689|"~     The pharmacokinetic behavior of vincristine in pediatric patients has not been well~     characterized. The present study will obtain detailed information on vincristine~     pharmacokinetics in patients being treated for standard risk ALL on CCG protocols 1952/1962.~     A limited sampling strategy will be developed, and the interpatient and intrapatient~     variability of vincristine pharmacokinetics in children will be studied. A correlation~     between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.~   "
274529|NCT00001686|"~     This protocol is designed to evaluate children with cancer who appear to be probable~     candidates for future protocol entry or have disease manifestations that are of unique~     scientific importance or educational value.~   "
274530|NCT00001683|"~     Matrix metalloproteinases (MMPs) are a class of membrane bound enzymes that are involved in~     the degradation of the extracellular matrix. MMP-2 and MMP-9 have been associated with the~     progression of cancer. It is hypothesized than an imbalance between MMPs and MMP inhibitors~     allows the destruction of the extracellular matrix and enhances the ability of the tumor~     cells to grow and metastasize. By inhibiting MMPs, it is thought that angiogenesis and~     metastasis can be inhibited. This is a phase I study of COL-3, an oral matrix~     metalloproteinase inhibitor, in patients with refractory metastatic cancer. COL-3 is a~     chemically modified tetracycline derivative. Patients must have clinically progressive~     disease documented within 1 month prior to entry to be eligible for treatment. Patients must~     have also failed therapy of proven efficacy for their disease and have an ECOG performance~     status of less or equal than 2. Patients must be willing to travel from their home to the NIH~     for follow-up visits. Patients with brain metastases or primary CNS malignancies are not~     eligible. Concurrent therapy for their cancer (i.e., radiation therapy, chemotherapy, etc.)~     will preclude participation. We will be defining the maximum tolerated dose, the toxicity~     profile, characterizing the pharmacokinetics, and evaluating the effect of COL-3 on several~     biological endpoints.~   "
274875|NCT00000446|"~     This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption~     and crime-related post-traumatic stress disorder in those individuals with both disorders.~     This will be a 12-week, placebo-controlled, double-blind outpatient trial.~      All subjects will receive cognitive behavioral therapy in addition to a placebo or~     sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and~     6, 9, and 12 months after study entry.~   "
274531|NCT00001678|"~     This study attempts to identify the genes responsible for rheumatoid arthritis (RA), or~     inflammation of the joints. It is known that genes play an important role in RA, but their~     number and significance have not been determined. RA tends to run in families. This study~     will examine the DNA (hereditary material) of patients with RA and their family members to~     try to determine which chromosomes(s) contain the genes responsible for the disease.~      Patients with rheumatoid arthritis and their family members may be eligible for this study.~      Participants with RA who have a brother or sister with RA will undergo the following~     procedures:~        -  Review of their medical records~        -  Medical history~        -  Examination of the joints~        -  Hand X-rays~        -  Blood tests~      Participants who 1) do not have RA but who have a relative with the disease, or 2) have RA~     and a relative other than a brother or sister who has the disease will provide a blood sample~     or a buccal (cheek) cell sample. Cheek cells are obtained by swishing a small amount of~     mouthwash in the mouth or by lightly bushing the inside of the cheek with a swab or brush.~      The samples will be tested for rheumatoid factor, DNA studies, and HLA type (a blood type~     found on white blood cells). Certain HLA types have been associated with an increased risk or~     severity of RA.~   "
274532|NCT00001676|"~     This study will test the safety and effectiveness of combination therapy with~     cyclophosphamide (Cytoxan) and fludarabine in treating lupus nephritis (kidney inflammation).~     This condition, common in patients with systemic lupus erythematosus, is caused by abnormal~     action of immune cells called lymphocytes against the kidneys. Left untreated, severe cases~     can result in loss of kidney function. The current treatment of choice-intermittent high~     doses (pulses) of cyclophosphamide-does not work in all patients and causes infertility in~     many women. The rate of infertility in men is not known. This study will examine whether~     fludarabine can safely be given with significantly lower doses of cyclophosphamide, and if~     this combination controls kidney inflammation.~      Patients 18 years of age and older with severe lupus nephritis (called proliferative lupus~     nephritis) may be eligible for this study. Candidates will have a history and physical~     examination; blood and urine tests; chest X-ray; electrocardiogram; cancer screening that may~     include a Pap smear, mammogram, rectal examination, PSA testing, and sigmoidoscopy.~      Participants will be divided into one of the following treatment groups:~      Group 1-Patients undergo three treatment cycles of cyclophosphamide, taken by mouth, and~     fludarabine, injected subcutaneously (under the skin). Patients receive both drugs on day 1~     of the cycle, and fludarabine alone on days 2 and 3. This regimen is repeated once every 5~     weeks for three cycles.~      Group 2-Same as for Group 1, except fludarabine injections are given intravenously (through a~     vein) for the second treatment cycle. Patients in this group have frequent blood sampling~     during the first and second treatment cycles to monitor blood levels of the drug. Samples are~     collected before the first injection is given and at 0.5, 1, 1.5, 2, 4, 8, 24 and 48 hours~     after the third injection. A total 12 tablespoons of blood is drawn over a 2-month period.~      All patients will have blood drawn once or twice a week during the first two cycles and then~     less frequently to monitor blood counts. Some patients will have the following additional~     procedures to test the effects of treatment on lymphocytes:~        1. Blood sample collection~        2. Bone marrow aspiration-The skin over the hip bone is cleaned and a local anesthetic is~          injected into the outer covering of the bone. Bone marrow is suctioned through the~          needle into an attached syringe. The procedure is done before treatment begins, at the~          end of treatment, and 6 months after treatment.~        3. Tonsillar biopsy-The tonsils are numbed with a local anesthetic and 1 to 4 pieces of~          tissue are removed using special forceps. The procedure is done before treatment begins,~          at the end of treatment, and 6 months after treatment.~        4. Magnetic resonance imaging (MRI) of the abdomen-The patients lies on a table in a narrow~          cylinder (the MRI scanner) containing a strong magnetic field, which is used to create~          images of parts of the body in small section views.~      Patients will be followed for at least 24 months to monitor late side effects and the~     response to treatment.~   "
274533|NCT00001671|"~     Leukodystrophy is a disease of the white matter of the brain. White matter is the portion of~     the brain responsible for conducting electrical impulses from one area of the brain to the~     other. Insulating cells called myelin cover the brain and nerve cells in the white matter. If~     myelin becomes damaged electrical information cannot be transferred properly.~      Many patients suffering from leukodystrophies do not fit the description of any of the~     defined types of leukodystrophies and are therefore considered to have a leukodystrophy of~     unknown cause.~      The purpose of this study is to define groups of patients with leukodystrophies and to work~     toward finding the cause of the disorders. In order to do this, researchers will analyze~     patients with leukodystrophies of unknown causes. Patients will undergo clinical,~     neurophysiologic, biochemical, and genetic examinations and tests.~      Researchers believe that by studying these patients and their disorders they will be able to~     better understand the causes of myelin destruction, and eventually lead to effective~     treatments for these disorders.~   "
274534|NCT00001666|"~     Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to~     stimulate brain activity and gather information about brain function. It is very useful when~     studying the areas of the brain related to motor activity (motor cortex, corticospinal tract,~     and corpus callosum).~      Epilepsy is a condition associated with seizures as a result of an over excitable cerebral~     cortex. Despite the introduction of several new antiepileptic medications, less than half of~     the patients diagnosed with partial epilepsy are well controlled. However, studies have shown~     that non-invasive stimulation of the brain can decrease the excitability of the cerebral~     cortex.~      Researchers are interested in the potential therapeutic effects of TMS on patients with~     epilepsy that have responded poorly to standard medication. This study will use TMS to~     decrease the excitability of the areas of the brain responsible for seizures.~   "
274535|NCT00001664|"~     The purpose of this study is to assist training doctors about different diseases of the~     nervous system affecting sleep.~      Patients selected to participate in this study will have any of a variety of sleep disorders.~     They will undergo several tests including an overnight recording of brain activity, eye~     movement, leg movement, breathing, heart rate, and other measures.~      Results of these tests will be used to better understand diseases causing sleep disorders and~     may be used to develop better treatments for them.~   "
274536|NCT00001663|"~     Myoclonus is a condition related to epilepsy of involuntary twitching or jerking of the~     limbs.~      The purpose of this study is to determine if stimulation of the brain with magnetic pulses~     can decrease myoclonus. Researchers believe that this may be possible because in studies on~     normal volunteers, magnetic stimulation made areas of the brain difficult to activate for~     several minutes. In addition, early studies on patients with myoclonus have shown magnetic~     stimulation to be effective at decreasing involuntary movements.~      Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to~     stimulate brain activity and gather information about brain function. It is very useful when~     studying the areas of the brain and spinal cord related to motor activity (motor cortex and~     corticospinal tract). Repetitive transcranial magnetic stimulation (rTMS) involves the~     placement of coil of wire (electromagnet) on the patient's scalp and rapidly turning on and~     off the electrical current. The changing magnetic field produces weak electrical currents in~     the brain near the coil. This permits non-invasive, relatively localized stimulation of the~     surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending~     upon the location, intensity and frequency of the magnetic pulses.~      Researchers plan to use rTMS for 10 days on patients participating in the study. The 10 day~     period will be broken into 5 days of active repetitive magnetic stimulation and 5 days of~     placebo ineffective stimulation. At the end of the 10 day period, if the results show that~     rTMS was beneficial, patients may undergo an additional 5 days of active rTMS.~   "
274537|NCT00001662|"~     Glutamate is an amino acid released by brain cells that acts to excite other cells. Glutamate~     attaches to special sites on cells called AMPA (alpha-amino-2,3-dihydro-5 methyl~     3-oxo-4-isoxazolepropanoic acid) receptors. The brain cells responsible for releasing~     glutamate are damaged in Alzheimer's disease and other conditions affecting thinking and~     reasoning.~      Researchers would like to see if giving patients a drug that attaches to AMPA receptors~     improves the symptoms of Alzheimer's disease.~      CX516 (Ampalex) is a test drug that affects the AMPA receptors. This study will investigate~     the effectiveness and safety of CX516 on patients with Alzheimer's disease.~      Patients will be given capsules of CX516 or placebo (sugar pill that neither harms nor helps)~     for up to 16 weeks in different amounts. The effectiveness of the drug will be measured by~     neurological tests. Safety will be monitored by frequent check-ups and lab examinations.~   "
274841|NCT00000413|"~     This study will test an osteoporosis prevention program aimed at preadolescent girls between~     the ages of 10 and 12 who have not yet started their menstrual periods. Girls in this age~     group are adding large amounts of new bone to their skeletons. Adding more bone at this time~     of life can reduce a person's chances of developing osteoporosis (thinning bones) in later~     years.~      We will look at how this osteoporosis prevention program affects the amount of calcium in the~     girls' diets, the amount of weight-bearing exercise they do, and their bone mass measured~     using ultrasound testing of the heel.~   "
274539|NCT00001659|"~     Bereavement refers to the expected reactions and sadness associated with the loss of a loved~     one. It has been reported that the loss of a spouse is rated as the major life stressor among~     survivors of varying ages and diverse cultural backgrounds. Statistics have shown that in the~     United States over 800,000 men and women lose a spouse each year.~      A wide range of symptoms has been associated with bereavement including; depressed mood,~     tearfulness, sleep disturbances, and irrational behavior. Previous studies have shown that up~     to 50% of bereaved individuals can develop major depression. Bereavement has also been~     associated with dysfunction of the immune system. As a result, bereaved adults are more~     vulnerable to infection. However, the exact relationship between bereavement and immunity is~     uncertain.~      Researchers firmly believe that a relationship does exist between stress, more specifically~     bereavement, immunity, and the increased chance of dying following the loss of a long-term~     spouse.~      The objective of this study is to find possible links between bereavement, depression, and~     the immune system. This study will follow a group of elderly bereaved spouses and a group of~     elderly people who have not lost a long-term spouse. The group of bereaved individuals will~     be followed for approximately 13 months after the loss of their spouse and the group of~     controls will be followed for 13 months after entering the study. Researchers will make note~     of any clinical, biological, and immunological changes in any participants of the study.~   "
274540|NCT00001656|"~     The purpose of this study is to compare the effectiveness and side effects of the drugs~     clozapine and olanzapine in children and adolescents with schizophrenia and psychoses.~      Childhood psychosis is a serious disorder that may have devastating consequences. Effective~     treatments for the condition are under continual investigation. This study will examine the~     causes of and offer treatment for childhood psychosis.~      Participants in this study will undergo psychological tests, blood and urine tests,~     electroencephalogram (EEG), electrocardiogram (EKG), and magnetic resonance imaging (MRI)~     scans of the brain for the first 1 to 2 weeks of the study while taking their regular~     medications. Participants will then be tapered off their medications over 1 to 3 weeks and~     will continue to stay off medications for an additional 2 days to 3 weeks. During this time,~     participants will undergo psychiatric, neurological, and cardiac examinations as well as~     blood tests. After this period without medications, participants will be randomly assigned to~     receive either clozapine or olanzapine for 8 weeks. An EEG will be performed prior to~     treatment and after 6 weeks of study medication. Participants who respond well to the study~     drugs may continue to receive them through their own physician. Participants who do not~     respond to either clozapine or olanzapine or cannot tolerate their side effects will be~     treated individually with other drugs until optimum treatment is identified. Regular~     telephone updates and in person visits to NIH for repeat testing and MRIs will be conducted.~   "
274541|NCT00001654|"~     The dysregulated experience and expression of emotion is implicated in psychiatric disorders~     associated both with externalizing problems (aggressive, antisocial behaviors) and~     internalizing problems (anxiety, depression). Adolescence is a critical juncture in the~     development of these disorders because of the increased incidence and differentiation of~     clinical problems during this time period. This is a biobehavioral, longitudinal~     investigation of the role of emotion in the development of psychopathology in adolescence.~     The focus is on socialization experiences and biological processes that contribute to emotion~     dysregulation and disorder in male and female youths between 11 and 16 years of age. Groups~     studied include (1) comorbid externalizers and internalizers, (2) externalizers only, (3)~     internalizers only, and (4) asymptomatic youth. The adolescents are assessed again two years~     later, with instruments and paradigms similar to those used at Time 1. One theme pertains to~     the integration and disconnection of emotions across systems (e.g., physiological and~     self-report of experience), and how different patterns of emotion relate to psychopathology.~     A second theme pertains to development changes in how disorders are manifested (e.g.,~     increased differentiation along gender specific pathways). The anticipated number of patient~     days per year is 240 for adolescents and mothers, and 120 days for fathers.~   "
274542|NCT00001652|"~     The purpose of this research protocol is to screen and enroll individuals who have bipolar~     disorder and to track each person's course of illness in order to study the long-term course~     of illness and to elucidate possible clinical and biological predictors of acute and~     sustained treatment response. As a part of this protocol, subjects will: systematically be~     administered psychiatric rating scales such as the life-chart method (LCM) for daily~     assessment of mood, sleep, and behavior; be asked to participate in non-invasive research~     procedures, such as blood drawing for measurement of thyroid antibodies and intracellular~     calcium; and be medicated as is clinically appropriate. This protocol also serves as a~     stepping stone to other protocols such as the comparative acute and long-term efficacy of~     three antidepressants (#95-M-0129), and the efficacy of omega-3 fatty acids (#00-M-0004), for~     which separate written informed consents are obtained. Patients in this study are~     participants in the larger NIMH-Stanley Foundation Bipolar Network (SFBN), which involves six~     academic sites focused on better understanding the long-term course and treatment of the~     illness. The current protocol thus serves as an entry point for individuals with bipolar~     disorder for screening and detailed longitudinal assessment both prior to and in between more~     formal blind randomized IRB approved treatment protocols.~   "
274557|NCT00001630|"~     Platelets are particles found along with red and white blood cells in the blood that play a~     role in the process of blood clotting. Disorders affecting the platelets can lower the amount~     of platelets in the blood and put patients at risk of bleeding. The condition of low~     platelets is referred to as thrombocytopenia.~      Thrombocytopenia can be associated with a variety of diseases including cancer, leukemia,~     tuberculosis, or as a result of an autoimmune reaction. Autoimmune reactions are disorders in~     which the normal immune system begins attacking itself. Autoimmune thrombocytopenia (AITP) is~     a disorder of low blood platelet counts in which platelets are destroyed by antibodies~     produced by the immune system.~      Unfortunately, many patients with AITP do not respond to standard treatments for~     thrombocytopenia. Cyclophosphamide is a drug that works to suppress the activity of the~     immune system. Researchers believe that combining this drug with transplanted rescued blood~     stem cells may provide effective treatment for AITP.~      The purpose of this study is to explore the affordability and safety of this therapy for the~     treatment of AITP. The effectiveness of the therapy will be measured by the number of~     patients whose platelet levels rise greater than 100,000/m3.~      If this treatment approach appears affordable, this study will form the basis for a larger~     study to compare alternate treatment approaches.~   "
274543|NCT00001651|"~     This study will examine how quickly white blood cells called CD4 lymphocytes replicate~     (divide) and how long they live in both HIV-infected and non-infected people by measuring how~     quickly the genetic material (DNA) of cells is replicated. To do this, participants will~     receive infusions of glucose, a non-radioactive form of a type of sugar. Cells normally use~     glucose to make various products needed for cell growth and replication, including cell DNA.~     Measuring how much glucose cells incorporate into their DNA can provide important information~     about cell replication. This rate of incorporation will be examined and compared in~     HIV-infected people and in healthy, normal volunteers.~      HIV-infected patients and non-infected healthy volunteers 18 years of age and older may be~     eligible for this study. Candidates will be screened with a medical history, physical~     examination, chest X-ray, electrocardiogram (EKG) and blood tests.~      Participants will be given a continuous infusion of glucose at a dose of up to 60 grams~     (about 2 ounces) per day for up to 5 days. The glucose will be delivered through a catheter~     (thin plastic tube) placed in an arm vein. Blood samples will be collected as often as daily~     in the first week following the infusion and then from twice a week to once a month for up to~     4 years. Alternatively, patients may undergo leukapheresis a procedure for collecting~     quantities of lymphocytes up to 10 times during the first month after the infusion, and~     possibly later as well, but no more often than once every 2 weeks. For this procedure, whole~     blood is collected through a needle in an arm vein. The blood circulates through a machine~     that separates it into its components. The white cells are removed and the rest of the blood~     is returned to the body either through the same needle or through a second needle in the~     other arm. Participants may be asked to receive up to four glucose infusions. There will be~     at least a 2-week interval between infusions. Participants who have more than three~     leukapheresis procedures within 3 weeks will have at least 6 weeks between infusions.~      Participants will be followed periodically in the outpatient clinic for evaluation and tests.~      This study may provide a better understanding of how HIV causes disease and progressive~     weakening of the immune system and how therapies affect immunity.~   "
274544|NCT00001650|"~     This study will examine how quickly white blood cells called CD4 lymphocytes reproduce and~     how long they live in people infected with HIV. It will do this using bromodeoxyuridine~     (BrDU), a compound that is structurally similar to thymidine, one of the building blocks of~     DNA. BrDU gets incorporated into DNA instead of thymidine, but it can only get into cells~     that are replicating. Therefore, measuring the proportion of cells with BrDU indicates how~     many cells are replicating.~      HIV-infected patients 18 years of age and older may be eligible for this study. Candidates~     will be screened with a medical history, physical examination, chest X-ray, electrocardiogram~     (EKG) and blood tests.~      Participants will be given an infusion of BrDU through a catheter (thin plastic tube) placed~     in an arm vein. Blood will be drawn up to 4 times in the first 24 hours after the infusion.~      Additional samples will then be collected as often as daily for the first week, twice a week~     for the next 3 weeks and then weekly to monthly for up to 1 year. Some patients may undergo a~     tissue biopsy (removal of a small tissue sample from a lymph node, tonsil or colon) or~     computed tomography (CT) scans of the thymus (a small gland between the lungs that~     manufactures lymphocytes. Some patients will have a second infusion in order to examine~     changes in the rate of CD4 replication over time or following potent antiretroviral therapy.~     Patients will be followed in the clinic periodically for the first year and then will be seen~     in the clinic or contacted by telephone once a year for 4 more years.~      The results of this study may provide a better understanding of how HIV causes disease and~     how therapy affects the immune system.~   "
274545|NCT00001649|"~     This study will evaluate the effectiveness of the drug valaciclovir in preventing~     transmission of genital herpes from an infected to an uninfected sexual partner. Genital~     herpes is caused by the herpes simplex virus 2 (HSV-2), or, infrequently herpes simplex virus~     1 (HSV-1). Valaciclovir prevents the herpes virus from multiplying and may also reduce its~     transmission between partners.~      Couples 18 years of age and older in which one partner is infected with HSV-2 (source~     partner) and the other is not (susceptible partner), may be eligible for this study.~     Candidates will be screened with blood tests for routine laboratory studies and to verify the~     presence or absence of HSV-2 or HSV-1 infection.~      Participants will give a medical history, undergo a physical examination, including genital~     examination, and receive counseling on safer sex practices and how to recognize signs and~     symptoms of a possible first episode of genital herpes. Source partners will also be~     counseled on transmission of genital herpes, and susceptible partners will be interviewed~     about their sexual history and practices. The source partner will be randomly assigned to~     take either a 500-mg tablet of valaciclovir or placebo (a pill with no active ingredient)~     daily for 8 months. All participants will be given diary cards to complete for a month-the~     source partner will record any drug side effects and the susceptible partner will record any~     signs or symptoms of possible HSV infection.~      Participants will be seen in the clinic once a month for 8 months. At these visits, source~     partners will 1) return unused study medication and the completed diary card; 2) discuss any~     adverse drug side effects experienced in the last month; 3) review medications other than the~     study drug taken in the last month; 4) undergo counseling on safer sex practices,~     transmission of genital herpes, and recognizing signs and symptoms of a first episode of~     genital herpes; and 5) review symptoms and recurrences of genital herpes experienced during~     the last month. During the final visit, they will also provide a blood sample for routine~     testing and possible use in future studies. Susceptible partners will 1) have a blood sample~     drawn for HSV testing; 2) undergo safer sex counseling; 3) review any symptoms experienced~     over the last month; 4) be interviewed about sexual exposure and practices; and 5) return the~     completed diary card.~      Source partners who have a recurrence of genital HSV while on the study will be asked to have~     their lesions cultured and will be offered open-label valaciclovir treatment. Susceptible~     partners who contract genital herpes from the source partner during the study will have a~     genital examination to verify a fist episode of genital herpes and will receive 10 days of~     open-label treatment with valaciclovir. Cultures will be taken from the mouth and genitals,~     current medical conditions will be reviewed, blood samples will be drawn on treatment days 1~     and 10, and treatment side effects will be reviewed on days 5 and 10.~      At the end of the study, infected partners will be offered a 12-month course of valaciclovir,~     one 500-mg tablet daily. Participants will be followed in the clinic once every 3 months to~     provide blood samples, return unused study medication and the diary card, discuss any drug~     side effects, review medications taken besides the study drug, and review symptoms or~     recurrences of genital herpes.~      All participants will be asked to complete a questionnaire for gathering information about~     people with genital herpes and people at risk for the infection.~   "
274546|NCT00001648|"~     This study will examine the structure of the receptor molecule for the herpes simplex virus~     (HSV) and determine if the receptor's structure is related to susceptibility to infection~     with the virus. There are two types of herpes virus-HSV-1 and HSV-2. HSV-1 commonly causes~     cold sores, and HSV-2 usually causes genital herpes. The herpes virus enters (infects) cells~     through protein molecules on the cell's surface. This study will explore possible differences~     between the structure of the HSV receptor molecule in different people to understand better~     how infection occurs. The study will also look at proteins on white blood cells (Fc~     receptors, cytokines and mannose binding protein) that may influence the risk of infection~     with HSV. Information from this study may lead to new treatments to prevent HSV infection.~      People 18 years of age and older who are infected with HSV and people who are not infected~     with the virus may be eligible for this study. Participants will have blood drawn to confirm~     whether or not they have been infected with the virus. The blood sample will also be used to~     study the genes for the HSV receptor, Fc receptors, cytokines, mannose binding protein and~     related proteins on the white blood cells. No more than 40 milliliters (8 teaspoons) of blood~     will be drawn.~      Participants who are found to have antibodies to HSV-2 will be offered counseling and advice~     on practicing safe sex techniques to help prevent sexually transmitted diseases, including~     HSV-2 infection.~   "
274558|NCT00001627|"~     This study is designed to provide bone marrow and/or blood cells for other research studies.~     Patients participating in this study will be asked to provide small amounts of medical~     information and undergo a limited physical examination designed to detect the presence of any~     obvious blood disease. A blood and bone marrow sample will be obtained to verify that the~     patient has normal blood cell production.~      Researchers plan to obtain bone marrow samples to be used in laboratory studies directed~     toward understanding the formation of blood cells. Bone marrow samples will be taken from the~     hip bone of patients and healthy volunteers.~      These samples are valuable to many research studies within the Hematology Branch of the~     National Heart, Lung, and Blood Institute, including studies of normal and abnormal~     production of blood cells, the viral causes of blood diseases, and the role of the immune~     system in bone marrow failure and related conditions....~   "
274547|NCT00001647|"~     This study will evaluate the safety and immune system effects of infusing HIV-infected~     patients with multiple doses of lymphocytes (white blood cells) from their non-infected~     identical twin. It will determine whether the donated lymphocytes can improve immune function~     and reduce viral load in the infected twin.~      Identical twin pairs-one who is infected with HIV-1 and one who is negative for the virus-may~     be eligible for this study. Candidates will be screened with blood tests, a medical history~     and physical examination.~      Both twin participants will receive a tetanus booster shot, if needed. The non-infected twin~     will undergo apheresis to collect white blood cells. For this procedure, whole blood is~     collected, similar to the procedure for donating a unit of blood from a needle in the arm.~     The blood flows through a cell separator machine where the white cells are removed, and the~     rest of the blood (red cells, plasma and platelets) is returned to the donor through a~     catheter in the opposite arm.~      The collected lymphocytes will be given intravenously (through a vein) to the infected twin~     over a 60-minute period. This procedure-apheresis and infusions-will be repeated 4 days a~     week to complete one cycle. The cycles will be repeated about every 8 weeks for 6 cycles~     (about 1 year).~      The infected twin will have blood samples drawn on the first day of each cycle, 2 weeks after~     the beginning of each cycle, and 4 weeks after each cycle to evaluate immune status, viral~     load and other safety parameters. The frequency of these blood tests may change as the study~     progresses. The infected twin will also undergo apheresis immediately before each cycle of~     infusions and one month later to test the white cells for certain immune features. The number~     of apheresis procedures may be reduced as the study proceeds.~   "
274548|NCT00001645|"~     The purpose of this study is to evaluate, treat and follow patients with parasitic~     infections.~      People with a known or suspected parasitic infection who are at least 1 year old may be~     enrolled. This study does not involve any experimental treatments.~      Participants will have a physical examination and laboratory tests on blood, stool, or urine.~     Blood samples may be collected at regular intervals, but no more than 450 ml (15 ounces) of~     blood will be drawn from adults, and no more than 7 ml (1-1/2 teaspoons) per kg (2.2 pounds)~     of body weight from children, in any 6-week period. Other tests may include x-rays,~     electrocardiogram (EKG), or tissue biopsy (surgical removal of a small tissue sample),~     depending on the individual s condition.~      Patients may be offered treatment or may be referred to another study that is more~     appropriate for the problem. Any treatment provided in this study will be according to~     standard medical practice for the patient s specific medical problem. Patients responses to~     treatment will be evaluated at regularly scheduled clinic visits. The length of time between~     visits and the total duration of the study for a given individual will be determined by the~     study doctor, based on that person s medical condition.~   "
274549|NCT00001644|"~     This study will try to define how and where HIV infection persists in the body by~     determining: 1) if there are cells where HIV can live for long periods of time without being~     seen and destroyed by the immune system; 2) if there are sites where anti-HIV drugs cannot~     penetrate enough to stop new HIV replication; and 3) if HIV in certain lymph nodes can remain~     infectious for prolonged periods of time. It will also explore whether immune system damage~     caused by HIV can be repaired after new virus replication is stopped with treatment.~      HIV-infected patients 18 years of age and older may be eligible for this study, which will~     include three groups as follows. Candidates will be screened with a medical history, physical~     examination, blood and urine tests and possibly chest X-ray and electrocardiogram.~      Participants will be divided into three groups according to CD4 count levels: > 500~     cells/microliter of blood; between 300 and 500 cells/microliter, and < 300 cells/microliter~     of blood. All participants will be treated with a combination of four antiretroviral drugs:~     indinavir, zidovudine, lamivudine and nevirapine. (Exceptions to this regimen may be made in~     certain circumstances for patients who cannot tolerate one of the four drugs.) In addition,~     they will undergo the following procedures:~      Blood tests - Blood tests will be done at screening and at study entry to evaluate the~     patient's health status and measure CD4 T cell count and plasma HIV levels; at the beginning~     of treatment to look for drug-related side effects; and during the course of the study to~     evaluate drug effectiveness in inhibiting HIV replication; CD4 T cell levels and function.~      Lymph node biopsy - Lymph node biopsies are done under local anesthesia. A small incision is~     made, the node is removed, and the incision is closed with stitches. Up to two nodes may be~     removed during each procedure. Patients with CD4 counts greater than 500 cells/microliter of~     blood and those with counts less than 300 cells/microliter will have three lymph node~     biopsies in order to 1) assess the effectiveness of therapy in inhibiting HIV replication in~     the nodes (the major site of replication); 2) determine how long HIV-infected cells may~     persist in the nodes after new replication is stopped by therapy; and 3) determine if immune~     damage caused by HIV can be repaired when virus replication is stopped. Lymph node biopsy in~     patients with counts between 300 and 500 cells/microliter of blood is required only at~     baseline, although follow-up biopsies are encouraged.~      Leukapheresis - In this procedure, whole blood is collected through a needle placed in an arm~     vein. The blood circulates through a cell separator machine where the white cells are removed~     and collected. The rest of the blood is returned to the body, either through the same needle~     used to draw the blood or through a second needle placed in the other arm. The collected~     white cells are used for special studies of the level and function of T cells before and~     after drug treatment. Patients with CD4 counts > 500 cells/microliter and < 300~     cells/microliter will undergo leukapheresis up to four times - at study entry and about 2, 6~     and 12 months after starting antiretroviral therapy. Patients with CD4 counts between 300 and~     500 cells/microliter will have this procedure either at study entry and 6 and 12 weeks after~     initiation therapy, or on the same schedule as the other patients.~   "
274550|NCT00001643|"~     The purposes of this study are to identify the gene or genes responsible for an inherited~     form of Parkinson's disease and learn more about how the disease develops.~      In Parkinson's disease, a deficiency of a brain chemical called dopamine impairs the function~     of the part of the brain that controls movement. As a result, patients may have difficulty~     moving or they may have uncontrolled movements of their hands and fingers. Parkinson's~     disease usually occurs sporadically, with no known cause. In a few families, however, the~     disease seems to be inherited through a gene mutation (change). There is a 50-50 chance that~     a parent with the mutated gene will pass it on to a child. Children who do inherit the~     abnormal gene may or may not go on to actually develop Parkinson's disease-the relative~     chance of this happening is not known.~      Individuals 18 years of age and older from families in which Parkinson's disease appears to~     be inherited may be eligible for this study. Participants will have their medical records~     reviewed, provide a personal and family medical history (by telephone or in person), and have~     a small blood sample (2 tablespoons) taken for genetic studies. The total time required for~     the study is about 1 to 2 hours.~      Participants are encouraged to meet with a NIH investigator or with a genetics specialist in~     their local area before testing to talk about the possible implications for themselves and~     their families of the test results....~   "
274603|NCT00001548|"~     The purpose of this study is to identify genes that affect susceptibility to~     obsessive-compulsive disorder (OCD). By identifying genes that increase or decrease the risk~     of OCD, researchers can better understand how the condition develops and ultimately improve~     treatment for people with OCD.~      OCD is a severe, familial condition that affects approximately 2% of the population. The way~     OCD is inherited is not clearly understood, but researchers believe it is complex and~     involves multiple genes. This study will detect and localize genes that increase or decrease~     susceptibility to OCD. The data collected from this study will be combined with data from~     other research studies to determine gene linkage and association.~   "
275384|NCT00000268|"~     The purpose of this study is to evaluate cocaine abuse and Attention Deficit Disorder~   "
274551|NCT00001641|"~     The purposes of this study are to identify the genes responsible for inherited connective~     tissue disorders and learn about the range of medical problems they cause. It will~     investigate whether specific gene changes cause specific medical problems and will establish~     diagnostic criteria (signs and symptoms) for the individual syndromes.~      Children and adults with a known or suspected inherited connective tissue disorder (Marfan,~     Ehlers-Danlos or Stickler syndrome, or other closely related disorders) and their family~     members may be eligible for this study.~      Patients enrolled in the study will have a medical history, physical examination and blood~     tests, as well as other procedures that may include:~        -  Echocardiogram (ultrasound of the heart)~        -  X-rays and other imaging studies, such as magnetic resonance imaging (MRI) or~          computerized tomography (CT) scans~        -  Lung function studies~        -  Urine tests~        -  Skin biopsy (removal of a small piece of tissue, under local anesthetic, for microscopic~          examination)~        -  Examination by various specialists (e.g., in ophthalmology, gastroenterology,~          rehabilitation medicine) as needed~        -  Questionnaires regarding chronic pain and fatigue, quality of life, and the impact of~          the connective tissue disorder on the patient and family.~      (Patients who wish to enroll but cannot travel to NIH may have a more limited participation,~     including review of medical records, telephone interview regarding personal and family~     history, and collection of a specimen (blood, skin biopsy, or other) for genetic testing.~      Patients will be notified of genetic testing results that show a change responsible for their~     connective tissue disorder. If they wish, the information will also be sent to their local~     health care provider, along with recommendations for additional tests or treatment options.~     No treatment is offered as part of this study.~      Participating family members who do not themselves have a connective tissue disorder will~     provide a small blood sample for gene testing and be interviewed by telephone about their~     personal and family health history. Those whose blood test results show a gene change~     associated with a connective tissue disorder will be invited to NIH for a discussion of the~     findings or referred to a genetic center in their area.~   "
274552|NCT00001640|"~     The purposes of this study are to identify the gene or genes responsible for an inherited~     form of Parkinson's disease and learn more about how the disease develops.~      In Parkinson's disease, a deficiency of a brain chemical called dopamine impairs the function~     of the part of the brain that controls movement. As a result, patients may have difficulty~     moving or they may have uncontrolled movements of their hands and fingers. Parkinson's~     disease usually occurs sporadically, with no known cause. In a few families, however, the~     disease seems to be inherited through a gene mutation (change). There is a 50-50 chance that~     a parent with the mutated gene will pass it on to a child. Children who do inherit the~     abnormal gene may or may not go on to actually develop Parkinson's disease-the relative~     chance of this happening is not known.~      Individuals 18 years of age and older from families in which Parkinson's disease appears to~     be inherited may be eligible for this study. Participants will have a brief medical~     examination, provide a personal and family medical history, and have a small blood sample (2~     tablespoons) taken for genetic studies. The total time required for the study is about 1 to 2~     hours.~      Participants are encouraged to meet with a NIH investigator or with a genetics specialist in~     their local area before testing to talk about the possible implications for themselves and~     their families of the test results....~   "
274553|NCT00001638|"~     This study is directed at evaluating patients with myocardial ischemia or poor blood supply~     to the heart muscle due to coronary artery disease. The major objective of this study is to~     determine the level of safety and effectiveness of magnetic resonance imaging at diagnosing~     coronary artery disease.~      In addition, this study will allow researchers at the National Institutes of Health to see a~     broad spectrum of disease, preserve clinical skills, and stimulate future ideas for clinical~     research....~   "
274554|NCT00001637|"~     Diseases such as leukemia, lymphoma, and multiple myeloma fall into the category of blood~     cancers. Some of these conditions can now be cured by bone marrow transplantation (BMT). The~     ability of BMT to cure these conditions has been credited to the use of high doses of~     chemotherapy, radiation therapy, and the antileukemia effect of the transplant.~      Because the effectiveness of BMT relies on the use of high doses of chemotherapy and total~     body irradiation (TBI), it is a therapy associated with toxic side effects. These side~     effects are often deadly and have limited BMT for use in patients under the age of 55.~      In this study researchers plan to treat older patients between the ages of 55 to 75 years~     with blood cell transplants taken from donors who are genetically matched relatives of the~     patient. In order to decrease the toxic side effects associated with the transplant,~     researchers will not use chemoradiotherapy. Instead they plan to use intensive~     immunosuppressive therapy and allow the transplanted cells to take effect....~   "
274555|NCT00001632|"~     The human heart is divided into four chambers. One of the four chambers, the left ventricle,~     is the chamber mainly responsible for pumping blood out of the heart into the circulation.~     Hypertrophic cardiomyopathy is a genetically inherited disease causing an abnormal thickening~     of heart muscle, especially the muscle making up the left ventricle. When the left ventricle~     becomes abnormally large, it is called left ventricular hypertrophy (LVH).~      Patients with HCM can be born with an enlarged left ventricle or they may develop the~     condition in childhood or adolescence, usually during the time when the body is rapidly~     growing. However, not all patients with the abnormal genes linked to HCM have the~     characteristic LVH.~      Currently, it is impossible to tell if a patient with the genes for HCM will develop LVH.~      A recently developed ultrasound tool called an integrated backscatter analysis (IBS), may~     allow researchers to determine those children who may later develop HCM and LVH. In order to~     test this, researchers plan to use IBS to study normal children with relatives diagnosed with~     HCM.~      This study will compare the results of IBS done on normal children with relatives diagnosed~     with HCM , normal children, and children with evidence enlarged heart muscle (HCM).~   "
274556|NCT00001631|"~     Blood flows to areas of the heart providing oxygen and fuel to the pumping muscle.~     Occasionally the arteries providing the fuel can become blocked. This occurs in coronary~     artery disease.~      Magnetic resonance imaging (MRI) can be used to evaluate the blood flow to different areas of~     the heart muscle. In this study magnetic resonance imaging will be compared to other~     diagnostic tests (radionucleotide perfusion studies) capable of measuring blood flow to heart~     muscle.~   "
274629|NCT00001487|"~     Dehydroepiandrosterone (DHEA) is a hormone produced by the adrenal gland. As humans grow~     older the levels of DHEA naturally decrease. Low levels of DHEA have been associated with a~     variety of harmful effects, including increased heart disease, decreased immune system~     function, decreased bone density (osteoporosis), high cholesterol, and increased fat to~     muscle ratio.~      Blood levels of DHEA and its sulfate form, DHEA-S, begin dropping when humans are in their~     20's. By the time humans are in their 40's and 50's, levels of DHEA and DHEA-S levels are at~     50% of their peak. Previous studies have shown that levels of these hormones are associated~     with feelings of well-being and enjoyment of leisure activities.~      In this study researchers are interested in the effects on mood and behavior of DHEA in men~     and women with mid-life related mood disorders. Specifically, researchers would like to find~     out if increasing levels of DHEA will lessen the symptoms associated with these disorders.~   "
274559|NCT00001626|"~     Severe Aplastic Anemia (SAA) is a rare and very serious blood disorder in which the bone~     marrow stops producing the cells which make up blood; red blood cells, white blood cells, and~     platelets.~      Researchers believe this is caused by an autoimmune reaction, a condition in which the~     natural defense system of the body begins attacking itself. In SAA the immune system begins~     attacking the bone marrow. Red blood cells are responsible for carrying oxygen to all of the~     organ systems in the body, and low numbers (anemia) can cause difficulty breathing and~     fatigue. Platelets are responsible for normal blood clotting and low numbers can result in~     easy bruising and bleeding which can be deadly. White blood cells are responsible for~     fighting infections, and low numbers of these can lead to frequent infections, the most~     common cause of death in patients with aplastic anemia.~      SAA can be treated by bone marrow transplant (BMT) or by drugs designed to slow down the~     immune system (immunosuppressants). BMT can be successful, but it requires a donor with~     matched bone marrow, making this therapy available only to a few patients. BMT with unmatched~     bone marrow can fail and cause dangerous side effects.~      Presently, the two drugs used to treat SAA by slowing down the immune system~     (immunosuppression) are antithymocyte globulin (ATG) and cyclosporin A (CSA). When used in~     combination these two drugs can improve most patients condition. However, one third of the~     patients who respond to this therapy experience a relapse of SAA. In addition, some patients~     treated with ATG/CSA can later develop other disorders of the blood.~      Recently, researchers have found that another immunosuppressive drug called cyclophosphamide,~     has been successful at treating patients with SAA. In addition, patients treated with~     cyclophosphamide do not experience relapses or develop other disorders of the blood.~      In this study researchers would like to compare the combinations of antithymocyte globulin~     (ATG) and cyclosporin A (CSA) to cyclophosphamide and cyclosporin A (CSA) for the treatment~     of SAA....~   "
274560|NCT00001625|"~     Patients with high blood pressure, diabetes, and who are overweight are known to have defects~     in the way their body responds to insulin. The purpose of this study is to develop better~     methods for measuring the way body tissue responds to insulin and sugar (glucose).~      Researchers are planning to study four groups of patients.~        1. Normal volunteers~        2. Patients who have mild to moderate high blood pressure~        3. Patients who are overweight~        4. Patients who have mild to moderate diabetes controlled with oral medication~      In this study patients and volunteers will undergo two separate tests designed to determine~     how well insulin is working in the body. The first test is called a glucose clamp test.~     Patients will have two needles placed in the veins of their arms. One needle will be used to~     take blood samples, the other needle will be used to inject doses of sugar (glucose) and~     insulin.~      The second test is called the frequently sample intravenous glucose tolerance test. In this~     test patients will have sugar (glucose) injected into their veins followed by a slow injected~     dose (infusion) of insulin. Researchers will periodically take blood samples during the test.~      Patients participating in the study will not directly benefit from it. However, the~     information gained from this study may be useful for improving the diagnosis and therapy of~     diseases such as diabetes, obesity, and high blood pressure (hypertension).~   "
274561|NCT00001623|"~     Bone marrow transplants (BMT) are one of the accepted therapies used to treat leukemia.~     However, BMT have risks of complications. One potentially life-threatening complication is~     known as graft-versus-host disease (GVHD).~      The GVHD is a reaction caused by an incompatibility between donor cells and recipient cells.~     Antigens found on the recipient s cells are recognized by the donor s transplanted white~     blood cell lymphocytes. These lymphocytes begin attacking the recipient s cells and tissues~     and may lead to death.~      One of the most effective ways to prevent this reaction is to remove the lymphocytes from the~     transplanted marrow. Unfortunately, without lymphocytes the recipient s immune system will be~     lowered and may result in a relapse of leukemia or an infection.~      Researchers have shown they can perform effective BMT by removing the lymphocytes prior to~     the transplant and then later adding the lymphocytes back. This technique can reduce the~     potential for GVHD and preserve the graft-versus-leukemia (GVL) effect of the transplant.~      In this study researchers plan to use peripheral blood with lymphocytes removed rather than~     bone marrow. In order to increase the number of progenitor cells, the cells responsible for~     correcting the leukemia, donors will receive doses of G-CSF prior to the transplant. G-CSF~     (granulocyte colony stimulating factor) is a growth factor that increases the production of~     progenitor cells in the donor s blood stream.~      The study will be broken into two parts. The first part of the study will attempt to~     determine if peripheral blood with lymphocytes removed can prevent GVHD while preserving the~     GVL effect of the transplant.~      In the second part of the study, patients that received the transplant will have the~     lymphocytes added-back on two separate occasions in order reduce the chances of relapse and~     infection.~      The study is designed to treat up to 55 patients ages 10 to 60 years and follow their~     progress for 5 years.~   "
274562|NCT00001621|"~     This study was developed in order for the professional-staff at the Pulmonary-Critical Care~     Medical Branch (PCCMB) of the National Heart, Lung, and Blood Institute to maintain their~     skills and increase their understanding of lung diseases.~      The study will permit PCCMB staff members to evaluate and treat patients with lung disease~     who do not meet the criteria for other research studies.~   "
274563|NCT00001620|"~     This study allows the evaluation of subjects in order to determine their ability to safely~     participate in other active research studies.~      After subjects complete the screening process, they will be offered the opportunity to~     participate in an active research study, or if no appropriate studies are available~     information and recommendations will be provided for other treatment options.~   "
274564|NCT00001619|"~     Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the~     human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields~     to create images of the body and organs. Occasionally, researchers will give patients~     undergoing a MRI an injection of a substance called gadolinium. Gadolinium works by~     brightening areas of the magnetic resonance image, thereby improving the contrast.~      In this study researchers will use magnetic resonance imaging and contrast substances, like~     gadolinium, on normal volunteers in order to evaluate different aspects of its performance.~     Information gathered from this study may be used to develop more specific research studies~     involving MRI.~   "
274565|NCT00001618|"~     Bronchoalveolar lavage (BAL) is a diagnostic and therapeutic procedure conducted by placing a~     small fiberoptic scope into the lung of a patient, and injecting sterile water (saline) into~     the lung and removing the fluid. The sterile solution removed contains secretions, cells, and~     protein from the lower respiratory tract. This sample can be analyzed to provide more~     information about possible disease processes going on in the lungs.~      This protocol will be used to perform BAL, bronchial brushing, and bronchial wall biopsy in~     normal volunteers and patients with pulmonary disease. The samples collected during the study~     will be used to examine biochemical processes in the lung that may contribute to lung disease~   "
274566|NCT00001613|"~     Cataract, in which the lens of the eye is opacified, is the major cause of blindness. This~     study will examine protein material of the lens called crystallins to try to determine what~     causes nuclear cataracts, a type of cataract that forms in the central lens nucleus.~      Men and women age 45 years or older with a cataract may be eligible for this study.~     Candidates will be screened to determine what type of cataract they have and will undergo a~     complete eye examination, including a vision test, eye pressure test, and examination of the~     lens and retina.~      Patients selected for study will have a complete physical and eye examination, including~     photography of various parts of the eye, and ultrasound measurements of the eye. They will~     then have cataract surgery, either with or without intraocular lens implantation, and will~     have follow-up examinations 1 week, 3 weeks, 5 weeks and 8 weeks after surgery.~      Tissue from the lenses removed during surgery will be given to NEI scientists for research on~     the causes of age-related nuclear cataracts.~   "
274567|NCT00001611|"~     This study will investigate whether medication for cytomegalovirus (CMV) retinitis-a viral~     infection of the eye-can safely be stopped in HIV-infected patients whose immune function has~     improved from anti-HIV therapy. Medicines taken to fight CMV infection (ganciclovir,~     foscarnet, and cidofovir) can cause serious side effects, such as low blood counts and kidney~     damage. Stopping these medications may, therefore, be beneficial.~      Patients with HIV infection who develop CVM retinitis usually have very low levels of~     infection-fighting white blood cells called CD4 cells-less than 50 cells per microliter of~     blood. New anti-HIV medications have been able to raise CD4 levels and improve immune~     function in many patients. This study will see if patients with CD4 levels above 150 cells~     per microliter can fight CVM retinitis without additional anti-CVM drugs.~      HIV-infected patients with CVM retinitis will have a physical examination and complete eye~     examination. These tests will be repeated after 2 weeks. If there is no evidence that the CMV~     infection has progressed, and if it is in a location that is not immediately~     sight-threatening, anti-CMV medications will be stopped. Patients will be examined every 2~     weeks for 3 months and then every 3 weeks for the next 3 months. Patients whose CD4 count has~     remained above 100 after 6 months will continue to be followed every 4 weeks until the CVM~     infection becomes active again. At that time, anti-CVM medicines will be re-started. Patients~     will also have blood and urine samples taken to test for levels of HIV and CMV in the blood~     and urine, and will be interviewed about their vision and how it affects daily activities.~   "
274568|NCT00001610|"~     This study will measure the normal range of the human electro-oculogram (EOG) in people of~     various age groups. EOGs are recordings of electrical signals generated by the retina (the~     light-sensitive tissue in the back of the eye) when going from a dark to a bright~     environment. They provide valuable information about the function of the eye in health and~     disease. A knowledge of what results are to be expected in tests of normal, healthy eyes will~     be valuable in assessing EOG results in patients with known or suspected retinal diseases.~      Normal volunteers from ages 6 to 65 who have healthy eyes and normal eyesight will~     participate in this study. Candidates will undergo tests to check vision and the health of~     the eye. Study participants will then have an electro-oculogram. In this test, eye drops are~     placed in the eye to enlarge the pupils. Two electrodes (small disks that picks up electrical~     signals) are attached to the left and right of each eye and one to the forehead. (These are~     similar to electrodes placed on the body during an electrocardiogram (ECG), which measures~     electrical signals from the heart.) During the EOG recording, the volunteer looks at the~     inside of a hollow sphere, following with their eyes small red lights that turn on and off.~     The background light is also turned on or off during the test. Some volunteers may be asked~     to repeat the EOG at another time.~      Study participants may also be asked to provide a blood sample for tests to study how the~     immune cells in the blood respond to proteins found in the retina. The response from normal~     volunteers will be compared with that of patients with eye diseases like retinitis~     pigmentosa.~   "
274569|NCT00001609|"~     The objective of this study is to discover the genes responsible for the development of~     hereditary cataracts in families. A cataract is clouding of the lens of the eye that~     obstructs the passage of light and may impair vision. Information from this study may provide~     a better understanding of why hereditary cataracts form and perhaps lead to the development~     of a test that can predict who will likely be affected and to what degree.~      Patients or family members of patients with inherited cataracts who participate in this study~     will be asked questions about their family history, especially concerning eye disease or~     cataracts, and a family tree will be drawn. They will undergo a complete eye examination,~     including photographs to document the clarity or opacity of the lens. In addition, a small~     blood sample will be drawn for use in gene mapping studies of inherited cataract.~   "
274570|NCT00001606|"~     This studied is designed to discover the genes that cause hearing impairment. More precisely,~     this study aims to map and clone genes that are important for the development and maintenance~     of the anatomy and physiology related to hearing (auditory system).~      The study will begin by finding large families who have members with hearing impairment. Once~     families are found, members with and without hearing impairment will be evaluated by an~     audiologist and a clinician (doctor). An audiologist, is a person trained in evaluating,~     habilitating, and rehabilitating people with disorders of hearing function. The clinician's~     responsibility is to examine the patients and check for other signs and symptoms related to~     hearing.~      Finding the gene for hearing impairment requires:~        1. <TAB>DNA samples of hearing impaired family members, taken from standard blood samples.~        2. <TAB>DNA samples of members of the family without hearing impairment, taken from~          standard blood samples.~        3. <TAB>Results of hearing tests conducted by the audiologist for all participants.~      Once all members of the family are evaluated researchers can create a pedigree. A pedigree is~     like a family tree that charts members of a family with a genetic disorder, like hearing~     impairment. Pedigrees are used to determine the mode of inheritance of the gene responsible~     for a particular condition.~      Finally, researcher intend on using all the information gathered as well as methods for~     genetic analysis to map out the location of the gene. Patients participating in this study~     will not directly benefit from its research, but scientific understanding achieved may help~     researchers better understand the auditory system and someday prevent deafness.<TAB>~   "
274571|NCT00001604|"~     Stuttering is an abnormality in speech that affects the rhythm of speech. People who stutter~     know what they wish to say, but at the time are unable to say it because of involuntary~     repetition, unnecessary lengthening (prolongation), or early stopping (cessation). Stuttering~     is characterized by repetitions or prolongation of the first syllable, or silent~     prolongations, sometimes known as blocks.~      Researcher intend on studying the genetic basis for stuttering. The goal of the study is to~     find the genes that help cause stuttering and determine regions of the human genetic make-up~     (genome) that are linked to stuttering.. To do this researchers will study the patterns of~     inheritance in families who have had members who stutter.~      The study has two objectives.~      The first objective is to develop a large collection of DNA samples from individuals in~     stuttering families, that will include both members that stutter and who do not stutter.~      The second objective of the study will be to find out the basic combination of genes~     (genotype) making up all of the participants DNA. Once this is completed researchers hope to~     map out and find areas or regions of DNA that are linked to stuttering.~      Genetic linkage is the initial step in positional cloning, and the cloning of genes which~     predispose individuals to stuttering is a long term goal of this research study.<TAB>~   "
274572|NCT00001603|"~     The goal of this study is to learn how tumors of the upper airway and digestive passages~     (tongue, throat, mouth, and voicebox) affect the body's immune defenses and energy storage.~      Previous studies have shown that tumors of the vocal tract produce signals that could help~     the tumor escape the body's immune defenses and use the body's energy and mineral stores to~     grow.~      Researchers are hoping to learn more about what signals give tumor cells an advantage to live~     and grow, how tumor cells control these signals, and how these signals affect the rest of the~     body. This study will look closer at researchers belief that tumors in the vocal tract~     contain genes (genetic information) that abnormally function to allow the tumors to survive~     and grow against the attack of the body's normal immune system~      Patients with cancerous tumors (squamous cell carcinoma) and benign (non-cancerous) tumors~     (papilloma) of the upper aerodigestive tract who are candidates for standard or~     investigational therapy are eligible to participate in this study.~      Tumor cells will be collected from patients participating in the study, who will undergo~     standard surgical treatment or biopsies for their conditions. Once tumor cells are collected~     they can be analyzed for their genetic make-up.~      In addition, patients will undergo several tests using skin, blood, and urine to look closely~     at the function of their immune systems and metabolism.~   "
274573|NCT00001602|"~     Stuttering is an abnormality in speech that affects the rhythm of speech. People who stutter~     know what they wish to say, but at the time are unable to say it because of involuntary~     repetition, unnecessary lengthening (prolongation), or early stopping (cessation). This study~     is designed to increase understanding of the genetic factors that may relate to stuttering.~      Deoxyribonucleic acid (DNA) is a protein found in the nucleus of all cells. It is responsible~     for carrying the genetic information of the organism. DNA provides the directions for making~     all of the substances in the human body. DNA can be linked together in small segments called~     genes. Genes can contain information about anything related to an organism.~      In order for researchers to determine what genes are directly related to stuttering they must~     conduct several types of studies.~      Linkage studies, are studies of families that have a lot of members who stutter from several~     generations. The linkage studies will be completed using adult individuals who are diagnosed~     as persons who stutter and persons who have never stuttered, from one or more families with~     large numbers of family members who have stuttered over several generations.~      Candidate gene studies, look closely at genes suspected to be related to stuttering in~     patients who may or may not have a significant family history of stuttering.~      By conducting these studies, researchers hope to learn more about genes related to stuttering~     and ultimately find out what causes stuttering.~   "
274574|NCT00001601|"~     This study offers evaluation and treatment of patients with diseases of the mouth or systemic~     diseases that involve the mouth. The protocol is not designed to test new treatments; rather,~     patients will receive current standard of care treatments. The purposes of the study are: 1)~     to allow NIDCR's Gene Therapy and Therapeutics Branch staff to gain more knowledge about oral~     soft tissue diseases and possibly identify new avenues of research in this area; and 2) to~     establish a pool of patients who may be eligible for new studies as they are developed.~     (Participants in this protocol will not be required to join a new study; the decision will be~     voluntary.)~      Patients of any age with oral diseases or systemic diseases involving the mouth may be~     eligible for this study. Women of childbearing potential and women who are pregnant or~     breastfeeding will only have tests and procedures and receive medications that pose no~     greater than a minimal risk to the fetus.~      Participants will have a comprehensive dental and medical examination, including a physical~     examination of the head and neck. Additional tests and procedures that may be required for~     diagnosis and to guide treatment include the following:~        -  Blood and urine tests - for routine laboratory studies, assessment of kidney and liver~          function, and detection of viruses, fungi, bacteria or parasites~        -  Electrocardiogram - to record the electrical activity of the heart~        -  Biopsies - to examine tissue under the microscope. The method and number of biopsies~          depends on the individual's specific condition and the tissue to be removed. For all~          biopsies a local anesthetic (lidocaine with or without epinephrine) is injected at the~          biopsy site. A punch biopsy uses a small sharp cookie-cutter instrument to remove a~          small (about 1/10- to 1/5-inch) piece of skin. An excisional biopsy uses a small~          surgical knife or scalpel to remove a piece of tissue, usually requiring some stitches~          to close the wound.~        -  Diagnostic imaging - X-rays, photographs, or other tests as needed for diagnosis~      Treatments include tablets, injections and topically applied medications. All preparations~     are approved by the Food and Drug Administration and are commercially available. Patient~     follow-up may vary from one visit to intermittent visits over a number of years, depending on~     the patient's condition.~   "
274575|NCT00001600|"~     This study provides a mechanism for evaluating patients for possible participation in NIDCR~     clinical research studies. NIDCR studies involve three major areas-pain, neurosensory~     mechanisms, and pain-relieving drugs-all of which have specific requirements and patient~     characteristics. No treatment is offered under this protocol; it is intended to facilitate~     patient recruitment into NIDCR studies.~      Patients with unusual or unknown conditions that have or have not been diagnosed may be~     eligible for this screening study. Specific medical criteria for enrollment vary with the~     particular protocol for which the individual is being screened. Medical and dental histories~     will be obtained and participants will have a dental examination. Diagnostic procedures will~     be done in accord with standard medical and dental practice and may include X-rays, blood~     tests, and routine urinalysis, as appropriate. Participants found eligible for an active~     study may enroll in that study. Those who are not eligible for a current study may be~     re-evaluated for future studies within a year if they wish. After 1 year, participants for~     whom no appropriate studies are identified will be referred back to their primary doctor or~     referring physician or dentist.~   "
274581|NCT00001594|"~     We propose a longitudinal study of the natural history of types III and IV osteogenesis~     imperfecta for children age birth to 25 years. A consistent objective throughout this study~     is to obtain a comprehensive assessment of the natural history and progression of the~     multiple secondary features of osteogenesis imperfecta. In addition to radiographic, bone~     density, physical rehabilitation and dental manifestations, we will assess the~     cardiovascular, pulmonary, neurological, and audiology systems.~      The major objectives of this protocol focus on rehabilitation and physical therapy studies,~     pulmonary and cardiovascular function, neurological features, audiological studies and~     genetic and molecular biology aspects of OI. A major objective in this study is to expand the~     intensive rehabilitation and physical therapy studies of children with types III and IV OI.~     This objective continues the work that has been done in the Rehabilitation Department of the~     Clinical Center for the past 20 years on these patients. However, the focus of this objective~     is changing to include studies of scoliosis and its effect on function, studies of chest~     proportions and rib deformities, and studies of nonkinetic variables related to motor~     performance, such as temperament, competence, coping, and resilience in children with OI. The~     second major objective is the longitudinal study of pulmonary function in children with types~     III and IV OI. It is well known that cardiopulmonary complications are a major cause of~     disability and death in adults with OI; the developmental patterns of these complications,~     and whether susceptible individuals can be identified in childhood, is unknown. The third~     major objective of these studies of secondary features is to determine the incidence of~     basilar invagination and develop a monitoring and management plan for this neurological~     feature. Next, the prevalence, severity, age of onset and genotypic/phenotypic correlation of~     hearing loss among children with types II and IV OI remains poorly understood; therefore, the~     study of audiological features is our fourth major objective. The final major objective in~     this study is the continued study of the genetic and molecular biology aspect of OI. Patients~     will have skin biopsies for collagen studies at the biochemical and molecular level. Parents~     will have blood drawn for determination of mosaic status for the mutation that causes their~     child s OI. These studies will provide further information on genotype/phenotype correlation~     and other variables in OI genetics. As appropriate, bone chips from emergency or elective~     surgical procedures on the participants will be used to study osteoblast function in OI.~   "
274576|NCT00001599|"~     This study will evaluate the safety and effectiveness of thalidomide in treating Sjogren's~     syndrome. In this autoimmune disease, the immune system attacks the body's tear glands and~     salivary glands, causing dry mouth and dry eyes. Thalidomide has shown promise in treating~     other autoimmune disorders, such as rheumatoid arthritis and systemic lupus erythematosus.~      Women with Sjogren's syndrome who have dry eyes and dry mouth may be eligible for this study.~     Women of childbearing potential will not be considered for participation because of severe~     birth defects associated with thalidomide. Also, since Sjogren's syndrome affects many fewer~     men than women, men are excluded from this pilot study because they would be too few in~     number to assess as a separate group. Candidates will be screened with a medical history,~     physical examination, blood and urine tests, electrocardiogram, chest X-ray and pregnancy~     test. Tests will also be done to measure the conduction of electrical impulses along the~     nerves and to evaluate dryness of the eyes.~      Participants will be randomly assigned to take either thalidomide or a placebo (look-alike~     pill with no active ingredient). The thalidomide dosage will be increased gradually from a~     starting dose of 50 Mg. up to 300 Mg., depending on side effects. Women of childbearing age~     who have had a tubal ligation or longstanding infertility will have a pregnancy test every 2~     or 4 weeks.~      Participants will come to the clinic at the first study visit and again at weeks 4, 8 and 12~     for some or all of the following procedures:~        -  Patient assessment of dry mouth (rated on a scale from worst ever to best ever~        -  Patient assessment of dry eyes (rated on a scale from worst ever to best ever~        -  Patient health questionnaire and disease assessment rating~        -  Saliva collection~        -  Rose-Bengal or other dye tests for dryness - examination of the eyes under a bright~          light following administration of drops containing a dye~        -  Schirmer's I test for dryness - placement of a thin rectangular strip of filter paper in~          the eye following administration of anesthetic drops~        -  Blood tests to measure blood cell counts and levels of various immune substances in the~          blood, and to evaluate liver and kidney function~        -  Urine tests to evaluate kidney function~        -  Nerve conduction tests - measurement of the speed with which nerves conduct electrical~          impulses. Two nerves in the arm and one nerve in the leg will be tested.~      Participants will also be contacted by telephone every week to report any side effects.~   "
274577|NCT00001598|"~     This study will evaluate the effectiveness of the male hormone dehydroepiandrosterone (DHEA)~     in treating Sjogren's syndrome. This autoimmune disorder, in which the immune system attacks~     the salivary glands and tear glands, affects primarily women. Patients' eyes and mouth become~     drier over time, and can lead to problems such as serious tooth decay and eye irritations.~     Sex hormones seem to influence the immune response and may help decrease disease severity.~     DHEA has benefited some patients with two other autoimmune diseases, rheumatoid arthritis and~     systemic lupus erythematosus.~      Women 18 to 75 years of age with Sjogren's syndrome may be eligible for this 7-month study.~     At the initial visit, candidates will have a physical examination, routine blood and urine~     tests and eye and dental examinations, including a test to measure saliva production for~     screening purposes and to establish baseline values for participants.~      Those enrolled in the study will be randomly assigned to take either DHEA or placebo~     (look-alike tablet with no active ingredient) once a day for 6 months and will be monitored~     with follow-up visits at months 1, 3, 6 and 7. Physical examination, blood tests and~     urinalysis will be repeated at months 1, 3, 6 and 7; saliva will be collected at months 3, 6~     and 7; and eyes will be examined at 3 and 6 months. Because hormone changes may have both~     physical and emotional effects, patients will be asked questions about their mood, symptoms~     and side effects of treatment.~      It is not known if Sjogren's syndrome is associated with osteoporosis (bone thinning), but~     since this condition occurs in other autoimmune disorders, patient's bone density will be~     measured at the first visit, and blood drawn at 3 and 6 months will be tested for various~     substances associated with changes in bone density. A 24-hour urine collection at the first~     visit and later urine tests will also be tested for substances associated with bone thinning.~   "
274578|NCT00001597|"~     This study will attempt to develop and validate improved subjective measures of pain~     sensation and use these measures to evaluate pain sensitivity in patients.~      Normal healthy volunteers and dental patients undergoing third molar extraction may be~     eligible for this study. Participants will undergo the following procedures:~      Volunteers: Volunteers will participate in two 90-minute sessions in which they will receive~     and rate four heat stimuli per minute applied to the skin for a maximum of 36 minutes. The~     heat stimuli range from 37° (Degree)C to 51° (Degree)C (99° (Degree) F to 124° (Degree) F)~     and last 2 to 3 seconds. A drug commonly used in dental treatments may be administered during~     the second session. This will be either a maximum of 0.15 mg fentanyl, a short-acting~     narcotic pain killer, or a maximum of 5 mg saline, an inactive substance (placebo).~      Dental patients: Dental patients will participate in two 60-minute sessions. The first~     session will be on the day before the third molar extraction, and the second session will be~     immediately before the dental procedure. The heat stimulus procedure will be identical to~     that described above for normal healthy volunteers.~   "
274579|NCT00001596|"~     Hermansky-Pudlak Syndrome (HPS) is an inherited disease that results in decreased~     pigmentation (oculocutaneous albinism), bleeding problems due to a platelet abnormality~     (platelet storage pool defect), and storage of an abnormal fat-protein compound (lysosomal~     accumulation of ceroid lipofuscin).~      The disease can cause poor functioning of the lungs, intestine, kidneys, or heart. The most~     serious complication of the disease is pulmonary fibrosis and typically causes death in~     patients 40 - 50 years old. The disorder is common in Puerto Rico, where many of the clinical~     research studies on the disease have been conducted. Neither the full extent of the disease~     nor the basic cause of the disease is known. There is no known treatment for HPS.~      The drug pirfenidone blocks the biochemical process of inflammation and has been reported to~     slow or reverse pulmonary fibrosis in animal systems.~      In this study researchers will select up to 40 HPS patients diagnosed with pulmonary~     fibrosis. The patients will be randomly divided into 2 groups. The patients will not know if~     they are taking pirfenidone or a placebo sugar pill.~        1. Group one will be patients who will receive pirfenidone.~        2. Group two will be patients who will receive a placebo sugar pill~      The major outcome measurement of the therapy will be a change in the lung function (forced~     vital capacity). The study will be stopped if one therapy proves to be more effective than~     the other.~   "
274580|NCT00001595|"~     There is a variety of tumors affecting the pituitary gland in childhood; some of these tumors~     (eg craniopharyngioma) are included among the most common central nervous system tumors in~     childhood. The gene(s) involved in the pathogenesis of these tumors are largely not known;~     their possible association with other developmental defects or inheritance pattern(s) has not~     been investigated. The present study serves as a (i) screening/training, and, (ii) a research~     protocol.~      As a screening and training study, this protocol allows our Institute to admit children with~     tumors of the hypothalamic-pituitary unit to the pediatric endocrine clinics and wards of the~     NIH Clinical Center for the purposes of~      (i)<TAB>training our fellows and students in the identification of genetic defects associated~     with pituitary tumor formation, and~      (ii)<TAB>teaching our fellows and students the recognition, management and complications of~     pituitary tumors~      As a research study, this protocol aims at~      (i)<TAB>developing new clinical studies for the recognition and therapy of pituitary tumors;~     as an example, two new studies have emerged within the context of this protocol: (a)~     investigation of a new research magnetic resonance imaging (MRI) tool and its usefulness in~     the identification of pituitary tumors, and (b) investigation of the psychological effects of~     cortisol secretion in pediatric patients with Cushing disease. Continuation of this protocol~     will eventually lead to new, separate protocols that will address all aspects of diagnosis of~     pituitary tumors and their therapy in childhood.~      (ii)<TAB>Identifying the genetic components of pituitary oncogenesis; those will be~     investigated by (a) studying the inheritance pattern of pituitary tumors in childhood and~     their possible association with other conditions in the families of the patients, and (ii)~     collecting tumor tissues and examining their molecular genetics. As with the clinical~     studies, the present protocol may help generate ideas for future studies on the treatment and~     clinical follow up of pediatric patients with tumors of the pituitary gland and, thus, lead~     to the development of better therapeutic regimens for these neoplasms....~   "
274630|NCT00001486|"~     This large ongoing study at NIMH investigates the neurobiology of schizophrenia by~     identifying susceptibility genes, evaluating their impact on brain function to better~     understand how to treat and prevent this illness.~   "
275385|NCT00000267|"~     The purpose of this study is to evaluate the safety and efficacy of risperidone for cocaine~     dependence in individuals with schizophrenia/schizoaffective illness.~   "
274582|NCT00001591|"~     Technical advances in magnetic resonance imaging (MRI) and magnetic resonance spectroscopy~     (MRS) have provided researchers with the opportunity to study changes of the central nervous~     system (CNS) and improve diagnosis and therapy of CNS disease. New MRI and MRS techniques~     specifically designed for functional MRI (fMRI) and MRS imaging of the CNS will be evaluated~     in normal volunteers and in patients with CNS diseases. This study will develop and evaluate~     new magnetic resonance pulse sequences for performing MRI or MRS and compare the results to~     existing MR techniques.~      Patients and volunteers age 18 and older are eligible for the study. A history will be taken~     in which exclusion criteria (such as having a pacemaker or cochlear implants) will be~     addressed, and a pregnancy test will be administered to women of childbearing age. Each~     subject will also be asked to fill out a questionnaire.~      Study participants will lie in the MRI scanner from 20 minutes to 2 hours. A coil may be~     placed on the head and participants may be asked to do simple or complex tasks. A catheter~     will be placed in an arm vein and a contrast agent will be administered. This agent will~     allow structures in the brain to show up more clearly.~   "
274583|NCT00001589|"~     Iron has been proposed to contribute to atherogenesis in humans by facilitating the oxidation~     of lipoproteins. This observational study will evaluate the association between frequency of~     blood donation - expected to be associated with relatively reduced body iron stores in~     frequent donors - and carotid atherosclerosis. The primary outcome variable will be whether~     the presence and extent of asymptomatic carotid atherosclerosis as measured by ultrasound is~     greater in infrequent (less than or equal to 1 donations/year greater than or equal to 5~     years) vs. frequent (greater than or equal to 4 donations/year greater than or equal to 5~     years) blood donors. Body iron stores, lipid and hemostatic parameters, nitric oxide~     formation, inflammatory parameters, and markers of vascular oxidative stress will be analyzed~     as secondary outcome measures. Laboratory analysis and ultrasound testing will be performed~     blinded to the patient's phlebotomy and iron status. Sixty frequent (n=40 males greater than~     40 y/o, n=20 females greater than 50 y/o) and 60 infrequent (n=40 males greater than 40 y/o,~     n=20 females greater than 50 y/o) blood donors will be recruited for this study from the~     Department of Transfusion Medicine, W. G. Magnuson Clinical Center. All donors will be~     assessed for study eligibility and cardiovascular risks during the screening visit. The~     presence of atherosclerotic lesions by carotid ultrasound and secondary outcome parameters~     will be assessed during a second visit.~   "
274584|NCT00001586|"~     Background:~        -  Combined therapy with rituximab and fludarabine is the treatment of choice for advanced~          stage chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).~        -  A new technology called deoxyribonucleic acid (DNA) microarray can be used to gain~          knowledge about the genetic basis of CLL/SLL.~        -  Genetic studies of CLL/SLL may improve our understanding of what happens in the disease,~          help determine which patients are most likely to respond to treatment with fludarabine~          and rituximab, and identify new treatments.~      Objectives:~      -To gain further knowledge about CLL/SLL and the role of rituximab and fludarabine in~     treating the disease.~      Eligibility:~      -Patients 18 years of age and older with low, intermediate or high-risk CLL/SLL.~      Design:~        -  Patients with low-risk CLL/SLL do not receive treatment, but are followed every 3 to 6~          months and donate cells (through apheresis) or lymph nodes, or both, for research~          purposes.~        -  Patients with intermediate or high-risk CLL/SLL receive standard treatment with~          rituximab and fludarabine for six 28-day treatment cycles. Rituximab is given on day 1~          and fludarabine is given on days 1-5. (For the first cycle only, fludarabine treatment~          starts on day 2. This delay permits blood sampling on day 1 for the effect of rituximab~          on white blood cells.)~        -  Laboratory tests and imaging studies are done periodically to monitor drug side effects~          and the response to treatment. Tests include bone marrow biopsy and aspiration, blood~          tests and x-rays, including positron emission tomography (PET) and computed tomography~          (CT) scans.~   "
274585|NCT00001582|"~     This protocol is being submitted to consolidate, update, and expand two previously approved~     protocols (77-C-0066 and 82-C-0044) into a single protocol. The purpose of this study is to~     examine the factors involved in the regulation of the immune system of healthy individuals~     and to define the abnormalities in this regulation that underlies the immunological disorders~     of patients with a variety of immunodeficiency and malignant disorders. The studies will~     include the ex vivo phenotypic and functional analysis of the network of cells involved in~     humoral and cellular immune responses, and in vivo testing for the capacity to make~     delayed-type hypersensitivity and humoral responses following immunization with a variety of~     antigens. Individuals to be studied will include patients with a variety of malignancies and~     patients with primary and secondary immunodeficiency disorders. Selected family members or~     family members known to be genetic carriers of certain immunodeficiency diseases as well as~     normal, unrelated individuals will also be studied. A small number of procedures will be used~     including analysis of blood obtained by phlebotomy, apheresis, skin testing and recall~     antigens and immunization to assess humoral immunity.~   "
274586|NCT00001580|"~     Acquisition of fresh tumor and normal tissue samples are necessary for the preparation of~     cDNA libraries, microarray chips, and tissue specific probes, and proteomics development and~     validation. This protocol will allow acquisition of samples at the time of tissue sampling~     for surgery, diagnostic tests, or therapeutic phereses. These samples will be forwarded~     without patient identifiers, pathology reports, or other labels. Tissue pathology will be~     verified within the Laboratory of Pathology and samples used strictly for CGAP and Proteomic~     Initiative indications.~   "
274587|NCT00001576|"~     Patients with unresectable metastatic colorectal cancer confined to the liver will undergo a~     1 hour hyperthermic isolated hepatic perfusion (IHP) with escalating dose melphalan.~     Postoperatively, patients will be treated with hepatic arterial infusion of floxuridine~     (FUDR), 0.2 mg/kg/day and leucovorin (LV), 15 mg/M2/day as a 2-week continuous infusion~     regimen. Hepatic and systemic toxicity, response to treatment, duration of response, and~     survival will be followed.~   "
274588|NCT00001575|"~     This study will examine the use of a radioactive monoclonal antibody called yttrium~     90-labeled humanized anti-Tac (90 Y-HAT) for treating certain cancers. Monoclonal antibodies~     are genetically engineered proteins made in large quantities and directed against a specific~     target in the body. The anti-Tac antibody in this study is targeted to tumor cells and is~     tagged (labeled) with a radioactive substance called Yttrium-90 (Y-90). The study will~     determine the maximum tolerated dose of 90Y-HAT and examine its safety and effectiveness.~      Patients 18 years of age and older with Hodgkin's disease, non-Hodgkin's lymphoma and~     lymphoid leukemia who have proteins on their cancer cells that react with anti-Tac may be~     eligible for this study. Candidates are screened with a medical history and physical~     examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, computed tomography~     (CT) scan or ultrasound of the abdomen, positron emission tomography (PET) scan of the neck~     and body, and skin test for immune reactivity to antigens (similar to skin tuberculin test).~      Before beginning treatment, participants may undergo additional procedures, including the~     following:~        -  Patients with suspicious skin lesions have a skin biopsy. An area of skin is numbed and~          a circular piece of skin about 1/4-inch diameter is removed with a cookie cutter-like~          instrument.~        -  Patients with hearing loss have a hearing test.~        -  Patients with neurological symptoms have a lumbar puncture (spinal tap). A local~          anesthetic is given and a needle is inserted in the space between the bones in the lower~          back where the cerebrospinal fluid circulates below the spinal cord. A small amount of~          fluid is collected through the needle.~        -  Patients who have not had a bone marrow biopsy within 6 months of screening also undergo~          this procedure. The skin and bone at the back of the hip are numbed with a local~          anesthetic and a small piece of bone is withdrawn through a needle.~      Patients receive 90 Y-HAT in escalating doses to determine the highest dose that can be~     safely given. The first group of three patients receives a low dose and, if there are no~     significant side effects at that dose, the next three patients receive a higher dose. This~     continues with subsequent groups until the maximum study dose is reached. 90 Y-HAT is given~     through a vein (intravenous (IV)) over a 2-hour period. In addition, a drug called Pentetate~     Calcium Trisodium Inj (Ca-DTPA) is given via IV over 5 hours for 3 days to help reduce the~     side effects of the 90Y-HAT. In some patients, the 90 Y-HAT may also be attached to a~     radioactive metal called Indium-111 to monitor what happens to the injected material. During~     infusion of the drug, patients undergo PET scanning to trace the path of the injected~     material in the body. For this procedure, the patient lies in the scanner, remaining in one~     position during the entire infusion.~      Blood and urine specimens are collected periodically over a 6-week period following the~     infusion to determine the level of the radioactive antibody. Bone marrow, lymph node, or skin~     biopsies may be done to determine how much of the antibody entered these sites. Patients~     whose disease remains stable or improves with therapy may receive up to six more infusions of~     90 Y-HAT, with at least a 6-week interval between treatments.~   "
274880|NCT00000441|"~     This project will provide relevant clinical information for primary care practitioners~     treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo-~     controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and~     carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated~     alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a~     1-week posttreatment followup.~   "
274591|NCT00001569|"~     Two days prior to planned surgery, paclitaxel is infused IV over 24 hours.~      Patients will undergo cytoreductive surgery, to debulk tumor. Scope of procedure will vary~     with each patient, including a spectrum of possible procedures, such as splenectomy, liver~     resection, pancreatic resection or bowel resection.~      After cytoreductive surgery, continuous hyperthermic peritoneal perfusion (CHPP) surgery with~     cisplatin will begin by placing an influx and efflux catheters via abdominal wall. Perfusion~     rate of cisplatin is 1.5 L/min and the duration is 90 min.~      Postoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery.~      Dose escalation will proceed after patients at a given dose level receive 3 courses. In order~     to properly evaluate hematoxicity, a minimum of 3 weeks will be required before dose~     escalation. MTD is either the dose level immediately below the level at which 2 of 6 patients~     in a cohort experience nonhematologic dose limiting toxicity (DLT) or when 4 of 6 patients~     experience hematologic DLT.~      Two to 4 months after surgery, laparotomy will be conducted to determine response to~     treatment. If tumor size is decreased, patients will undergo a second treatment course~     identical to the same techniques and chemotherapy agents.~   "
274592|NCT00001568|"~     Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50~     mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min.~     Initial dynamic images will be obtained over the heart. Emission imaging will work from the~     midcervical region down to the perineal region.~      For CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over~     5 min. A single photon emission computed tomography (SPECT) transmission scan is performed~     over the same regions as the emission scans. Total dose from transmission scans should be no~     more than 20 mRad per patient visit.~      Patients then undergo exploratory laparotomy performed by two surgeons, one blinded to the~     results of the CEA-Scan and PET scan.~      At the completion of all exploration, all identified disease is biopsied for pathologic~     analysis and any resectable disease is removed.~      Patients are followed every 3 months for 1 year, every 6 months for the second year, and then~     after 3 years.~   "
274593|NCT00001567|"~     This study began as an efficacy study of interferon alpha-2a in patients with hairy cell~     leukemia. It was observed that most patients responded with interferon, but that very few~     complete responses were being obtained. Studies being done elsewhere confirmed the low~     complete remission rate. Once interferon was stopped, nearly uniformly disease progression~     requiring reinstitution of therapy was observed. There appear to be very few if any patients~     who will not require further therapy after receiving 12 or 18 months of continuous interferon~     treatment. Because of these findings, and in order to evaluate the safety and efficacy of~     long-term recombinant interferon-alpha (IFN-Alpha) in patients with hairy cell leukemia, we~     opted to administer interferon continuously to patients who were initially responsive to this~     drug. Of the 53 evaluable patients (of the 56 entered on this study), there was one complete~     remission, 41 partial remissions, 1 minor response, 9 patients with stable disease and only 1~     patient with disease progression. Fourteen patients continue to receive interferon without~     interruption with a median duration of continuous interferon treatment of 9.2 years.~     Thirty-four patients discontinued interferon for a variety of reasons, the most common being~     the development of acquired interferon resistance in association with interferon antibodies.~     The resistance to interferon was manifested early, in the first 18 months of treatment,~     except in two cases. An important finding in this study is the continued slow, but~     significant, hematologic improvement in absolute granulocyte and platelet counts beyond 18~     months of therapy, thereby indicating that prolonged treatment results in continued benefit~     rather than the production of antibodies with subsequent development of interferon~     resistance. Although it is clear from this study that hairy cell leukemia can be controlled~     in the long-term with interferon, longer follow-up will be necessary to determine if~     continuous therapy with interferon is better than intermittent therapy. The optimal therapy~     for hairy cell leukemia remains open to discussion. Although early reports suggested that~     2-chlorodeoxyadenosine was curative, additional studies with longer periods of follow up~     suggests that as many as 30% of patients will relapse. This study provides the only instance~     where continuous long term treatment with interferon has been evaluated. This provides an~     opportunity to evaluate the long term toxicity of chronic interferon therapy, the long term~     efficacy of this treatment and to evaluate the potential benefits of long term interferon in~     preventing second malignancies, a complication noted in about 15% of patients treated in~     other fashions.~      After their initial clinical evaluation, patients were given 3 million units of recombinant~     IFN-Alpha subcutaneously daily for 4 to 6 months. In responding patients, maintenance therapy~     was given at a dose of three million units subcutaneously 3 times per week. Responding~     patients have continued on therapy indefinitely.~   "
274594|NCT00001566|"~     This is a single arm study.~      The tumor specimen is analyzed for the presence of a fusion protein which corresponds to~     available peptides. Patients undergo T cell harvest 10 days after an initial priming~     peptide-pulsed antigen presenting cell (APC) vaccine is performed.~      Fresh APCs are utilized for initial priming vaccination. All subsequent vaccinations will use~     cryopreserved APCs. Minimum number of APCs administered per vaccination is 100,000/kg and~     maximum is 100,000,000/kg.~      Patients undergo cytoreductive therapy for the treatment of their particular malignancy. This~     therapy usually consists of multiagent chemotherapy in the context of a separate protocol.~      Following chemotherapy, infusion of harvested T cells followed by infusion of peptide-pulsed~     APC vaccinations occurs every 6 weeks for a total of 3 post-priming vaccinations. Influenza~     vaccine is administered by intramuscular injection concurrent to peptide-pulsed APC vaccines.~      Interleukin -2 (IL-2) is administered as a continuous intravenous (IV) infusion for 4~     days/week for 3 successive weeks starting on the same day as T cell /peptide-pulsed~     infusions.~   "
274595|NCT00001564|"~     Arm A:~      Peripheral blood apheresis by harvesting chemotherapy-naive T cells and populations enriched~     for professional APCs.~      T cells and APCs are separated from the apheresis product using countercurrent centrifugal~     elutriation and a monocyte rich fraction is collected.~      Autologous T cell transplantation during immunotherapy.~      Arm B:~      Cell harvesting is performed as soon as possible.~      Both Arm A and B:~      Patients receive intravenous infusion of irradiated peptide-pulsed antigen presenting cell~     vaccination (APC) products as well as intramuscular injection of influenza vaccine on the~     same day.~      Recombinant human IL-2 is administered within 4 hours of the peptide pulsed vaccine by~     continuous intravenous infusion for 4 days per week for 3 successive weeks.~      Primary toxic effect of this therapy is expected to be related to the IL-2 therapy. Patients~     with Grade 2 neurologic or cardiac or any Grade 3 or 4 toxic effects will discontinued IL-2~     therapy. If toxic effect is not resolved in 72-hours, the patient may remain on study but~     will not receive any further IL-2....~   "
274596|NCT00001563|"~     The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed~     setting. There is no standard treatment, and the few small studies that have been conducted~     have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus~     rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study~     include toxicity and response. Progression-free and overall survival will be measured. Tumors~     will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and~     EBV when possible....~   "
274881|NCT00000440|"~     This study is a double-blind, placebo-controlled outpatient trial to improve, through the~     addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent~     individuals currently taking naltrexone (Revia).~   "
274597|NCT00001561|"~     Both patients and marrow donors are treated on Regimen A; patients then proceed to Regimen B.~     The following acronyms are used:~      ABM Allogeneic Bone Marrow~      BU Busulfan, NSC-750~      CF Leucovorin calcium, NSC-3590~      CTX Cyclophosphamide, NSC-26271~      G-CSF Granulocyte Colony-Stimulating Factor (source not specified)~      GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor (Hoechst/Immunex), NSC-613795~      GVHD Graft-vs.-Host Disease~      Mesna Mercaptoethane sulfonate, NSC-113891~      MTX Methotrexate, NSC-740~      PP Unconjugated Myeloma Immunoglobulin plasma paraprotein, NSC-684150~      PP-KLH Myeloma immunoglobulin plasma paraprotein vaccine, NSC-678327, with keyhole limpet~     hemocyanin~      TBI Total-Body Irradiation~      TSPA Thiotepa, NSC-6396~      Regimen A (Donor and Patient): Vaccine Therapy with Immunoadjuvant. PP-KLH (individual~     myeloma immunoglobulin plasma paraprotein vaccine prepared from recipient's plasma~     paraprotein and conjugated with KLH); and PP; with GM-CSF.~      Regimen B (Patient): Myeloablative Radiotherapy and 2-Drug Combination Chemotherapy or 2-Drug~     Combination Myeloablative Chemotherapy followed by Hematopoietic Rescue with Growth Factor~     Support and GVHD Prophylaxis followed by Vaccine Therapy with Immunoadjuvant. TBI; and~     CTX/TSPA; or BU/CTX; followed by ABM; with G-CSF; and CYSP; MTX/CF; followed by PP-KLH; with~     GM-CSF.~   "
274598|NCT00001560|"~     This protocol presents the rationale, 25-year historical review, and methods for~     multidisciplinary, low-risk studies of individuals referred to the NCI Viral Epidemiology~     Branch (VEB). Referrals are generally for unusual types of cancer or related conditions,~     known, or suspected to be related to viruses. Kaposi's sarcoma in two homosexual men~     evaluated in 1981 is a classic example. These referral cases provide the basis for pilot~     studies that generate hypotheses, the development of protocols for formal investigations of~     promising leads, and help to set priorities for VEB.~      A VEB investigator who is a Staff Member at the NIH Clinical Center, interviews each subject,~     performs a physical examination, draws a blood sample, and, when appropriate for the disease~     or virus under study, obtains other clinically indicated biological specimens, such as urine,~     sputum, saliva, tears, semen, Pap smear, or cervical, anal, oral, or nasal swabs. On~     occasion, other relatively non-invasive studies may be indicated. Skin testing with~     conventional, licensed antigens for assessment of cellular immunity may be performed, and~     skin lesions may be biopsied or excised. Tumor or other tissue biopsies may be obtained when~     biopsy or surgery is clinically indicated for other reasons. Otherwise no surgery is~     performed, and no therapy is administered. Clinical referral to other components of NCI, NIH,~     or the private sector are made as needed. The biological specimens are frozen or otherwise~     preserved to be batch tested in current assays or future assays that will be developed. Such~     laboratory testing is performed either at VEB's own support laboratory, or collaboratively in~     other NCI, NIH, or extramural laboratories that have the needed expertise for the disease or~     virus under study.~      Occasionally, repeated or more long-term evaluation is required. More often, a single~     evaluation in the NIH outpatient clinic, or either at a collaborating physician's office or~     other suitable site in the field, is sufficient. The VEB investigator provides counseling~     relevant to the virus or disease under study, and about the interim study results. He or she~     makes appropriate referral if needed (e.g., to the Genetic Epidemiology Branch for genetic~     counseling). Clinically relevant results and the VEB investigator's interpretation of these~     results, are provided in writing to the subject's primary caregiver. Confidentially of the~     information that is obtained is carefully protected. The results of the study are summarized~     for publication in the peer review literature.~   "
274599|NCT00001552|"~     The purpose the study is to determine the genetic causes of specific voice disorders that run~     in families. Researchers are particularly interested in two conditions;~        1. Spasmodic dysphonia~        2. Vocal fold paralysis~      Familial vocal fold paralysis can be a life-threatening disorder that can cause difficulty~     with vocal fold movement for breathing and voice and sometimes for swallowing. Studies are~     ongoing at the NIH to better understand the pathophysiology and to relate it to the genetic~     pattern of inheritance. Families are being recruited to participate in these studies and are~     being provided with further information on the disorder and genetic counseling if desired.~     Physician referral is requested for affected members of families with vocal fold paralysis of~     an unknown cause occurring over at least 2 generations. All travel, lodging, examination and~     counseling costs are covered for both affected and unaffected members of a family.~     Examinations include: voice, laryngeal, neurological, electrodiagnostic testing, genetic~     counseling, and radiological studies....~   "
274600|NCT00001551|"~     According to studies, speech disorders with unknown causes (idiopathic) affect approximately~     5% of the population at some point in their life. Some of these disorders like, stuttering~     and cluttering, are known for being detected early, during speech development.~      Stuttering is characterized by sound and syllable repetitions and consonant/vowel~     prolongations. When stuttering is moderate to severe, it can interfere with a person's job~     and social activities.~      Speech articulation disorders are characterized by omissions, or substitutions of speech~     sounds. The speech of a person who clutters is often difficult to understand. People are~     often unaware of the errors they make when speaking causing treatment of the condition to be~     very difficult.~      The purpose of this research is to study an extended family whose members exhibit a pure form~     of speech articulation disorders~      In addition, the study will use data and information gathered from the study and use it to~     develop guidelines (criteria) for defining and differentiating patients with speech~     disorders.~   "
274601|NCT00001550|"~     Stiff-man Syndrome (SMS) is a chronic, progressive disorder of the nervous system. It is~     associated with painful muscle spasms and rigidity involving muscles of the limbs, trunk, and~     neck. The cause of the disease is unknown, but researchers believe it may be a result of an~     autoimmune process. Patients with Stiff-man Syndrome may produce antibodies that attack~     enzymes required for the normal function of the nervous system.~      Steroids, plasmapheresis, and intravenous immunoglobulin (IVIg) have been given to relieve~     some of the symptoms of Stiff-man Syndrome. However, none of these therapies have proven to~     be significantly effective.~      This study will attempt to determine the effectiveness of intravenous immunoglobulin (IVIg)~     for the treatment of Stiff-mann Syndrome. Patients participating in this study will be~     divided into two groups. Group one will receive 2 injections of IVIg once a month for three~     months. Group two will receive 2 injections of placebo inactive sterile water once a month~     for three months. Following the three months of treatment, group one will begin taking the~     placebo and group two will begin taking IVIg for an additional 3 months. The drug will be~     considered effective if patients receiving it experience a significant improvement in muscle~     function, mobility, and stiffness.~   "
274602|NCT00001549|"~     The purpose of this study is to improve understanding of neurological conditions. Patients~     participating in this study will continue receiving medical care, routine laboratory tests,~     and diagnostics tests (X-rays, CT-scans, and nuclear imaging), from their primary care~     physician. Doctors at the NIH plan to follow these patients and offer advice and assistance~     to their primary care physicians.~   "
274882|NCT00000439|"~     The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in~     treating individuals with alcohol dependence and comorbid bipolar disorder.~   "
274604|NCT00001547|"~     Use of the drug interferon-alpha (IFN-A), is associated with frequent and well characterized~     side effects like neurotoxicity. Neurotoxicity can cause symptoms of depression, agitation,~     anxiety, and/or confusion.~      The NIDDK is conducting a research study called, Combination of Alpha Interferon with Long~     Term Ribavirin Therapy for Patients with Chronic Hepatitis C (98-DK-0003). Patients~     participating in it are receiving interferon-alpha in addition to an antiviral medication~     called ribavirin. Researchers at the NIMH intend to study patients to learn more about how~     different medications can influence mood, thoughts and behavior.~      The primary purpose of this study is to determine if treatment with IFN-A in combination with~     ribavirin alters human brain biochemistry as measured by proton magnetic resonance~     spectroscopy (MRS).~      MRS uses strong magnetic fields in order to measure biochemical products of metabolism found~     in the brain. Researchers intend to perform MRS scans before, during, and after patients~     receive their medications~      Researchers believe that the combination of IFN-A/Ribavirin will directly affect specific~     areas of the brain and as a result, some patients will develop specific mood or cognitive~     symptoms. Patients often must stop taking these medications because of the side effects.~      This study will not contribute directly to the treatment of patient's Hepatitis C condition.~     However, the information gathered from this study will help researchers better understand the~     neuropsychiatric affects associated with interferon alpha and ribavirin therapy.~   "
274605|NCT00001545|"~     This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a~     potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through~     your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower~     intensities has helped some people with depression but we do not know what the results will~     be in your case using higher intensities, or whether you will be randomized to 3 weeks of~     high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive~     (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front~     art of your brain five times per week for the three weeks. Each rTMS treatment session should~     take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and~     blood sampling may require several hours per week. We will also ask you to have brain imaging~     procedures to see if these will predict response to high vs. low frequency rTMS. If you are~     randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the~     active stimulation frequencies for an additional 3 weeks. Responders to any phase will be~     offered an additional month of rTMS prior to study termination and recommendations of~     alternative treatments.~   "
274606|NCT00001544|"~     The purpose of this study is to improve the understanding of the genetic causes of specific~     neurologic and psychiatric disorders. The study will focus on conditions of mental~     retardation, childhood onset schizophrenia, attention deficit hyperactivity disorder (ADHD),~     atypical psychosis of childhood, and bipolar affective disorder.~      The study addresses the belief that there may be several genes contributing to the illness.~     Researchers intend to use several molecular genetic techniques in order to identify the areas~     of chromosomes containing genes responsible for the development of these disorders.~      Patients will be selected to participate in this study based on an early age of onset of~     their condition as well as the severity of the illness and the frequency of the illness among~     family members. Researchers will collect DNA samples from patients as well as affected and~     unaffected family members of each patient. The DNA samples collected will be analyzed for a~     variety of genetic abnormalities including; triplet repeat expansions, chromosome~     rearrangements, and polymorphisms.~   "
274607|NCT00001543|"~     This is a study investigating the hormones and substances important to the stress response.~     The hormone that is most directly responsible for stress response is called~     corticotropin-releasing hormone (CRH). CRH is produced in the hypothalamus of the brain and~     causes the pituitary gland to produce another hormone called ACTH. The hormone ACTH then acts~     on the adrenal glands causing them to produce the hormone cortisol.~      Unfortunately, CRH levels are unable to be measured in simple blood samples. However,~     substances like cortisol and leptin can provide information as to the activity of the~     hypothalamus.~      The hormone leptin is associated with the regulation of body weight and the normal~     maintenance of bodily functions (homeostasis). It is found in fat cell (adipocyes) and~     communicates the nutritional status of the body to the brain (central nervous system).~     Research using animals has shown that defects in the communication between leptin and the~     brain causes obesity (the state of being overweight). It has also been noted that obese~     humans tend to have high levels of leptin.~      By studying patients with abnormal genes responsible for leptin production, researchers have~     found that a least one leptin gene must be intact for the normal secretion of hormones to~     proceed. These results show that the hormone leptin is produced outside of the brain in fat~     cells and acts directly on the function of the hypothalamus within the brain. Researchers~     believe that leptin plays a key role in the normal release of hormones from the HPA axis.~      Researchers intend on continuing to study the role of leptin in fat distribution, and the~     activity of the HPA axis in normal volunteers. In addition, this study will focus on the role~     of leptin in depression, because depression is characterized by changes in food intake, body~     weight, and neuroendocrine function. Data gathered from this study will provide a better~     understanding of the causes and medical consequences of major depression.~   "
274608|NCT00001541|"~     This study will collect fluid and tissue samples from the bronchi (air passages to the lungs)~     of patients with Wegener's granulomatosis for laboratory examination. Wegener's~     granulomatosis is a type of vasculitis (blood vessel inflammation) that can affect many parts~     of the body, including the brain, nerves, eyes, skin, sinuses, kidneys, intestinal tract,~     joints, heart, lungs and other sites. About 85 percent of patients have lung involvement. The~     lining of the bronchi (bronchial mucosa) is composed of cells that produce mucus,~     inflammatory cells, and inflammatory mediators (chemicals produced in response to~     inflammation). Analysis of these various substances may provide insight into what causes~     different types of lung problems in Wegener's granulomatosis.~      Patients between 18 and 75 years of age with Wegener's granulomatosis who require~     bronchoscopy to evaluate the cause of their lung problem may be eligible for this study.~      Participants will undergo a bronchoscopy in the hospital intensive care unit (ICU). For this~     procedure, the mouth and throat are numbed with lidocaine jelly and spray. If needed, a~     sedative is given for comfort. A small plastic tube (intravenous catheter) is placed in a~     vein to give medications. A pencil-thin tube is then placed through the nose or mouth into~     the lung airways to examine the airways carefully.~      At the time of the bronchoscopy, patients in this study will undergo the following additional~     procedures:~        -  Bronchoalveolar lavage - Saline (salt water) is injected through the bronchoscope into~          the air passage, acting as a rinse. A sample of the fluid is then withdrawn and examined~          for infection, inflammatory cells and inflammatory chemicals. (This may be done as part~          of the standard medical care procedure.)~        -  Bronchial lavage - This procedure is similar to bronchoalveolar lavage, but less fluid~          is used to rinse larger airways.~        -  Bronchial mucosal biopsies - A small wire is inserted through the bronchoscope next to~          the bronchial lining. Forceps at the end of the wire pinch off a small piece of tissue~          for withdrawal and examination.~      The patient's heart rhythm and rate and oxygen levels are monitored during the procedure.~     When the procedures are finished, the patient is monitored in the ICU until the numbing~     effect of the anesthetic has worn off and then moves to a regular hospital bed for overnight.~      Patients whose test results show an isolated infection or isolated Wegener's lung tissue~     involvement and who are being treated or are eligible for treatment under another NIH~     protocol will be followed by X-ray for improvement of their infection or other lung~     involvement with treatment. Patients whose infection or lung tissue involvement improves may~     be asked to undergo a second bronchoscopy as described above, but for research purposes only.~   "
274609|NCT00001539|"~     This study will determine whether patients who have been infected with the Lyme bacteria,~     Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them~     and whether it is causing their symptoms. The information from this study may serve as a~     basis for developing stringent diagnostic criteria for Lyme disease and the establishment of~     future treatment trials.~      Individuals in the following categories may be eligible for this study: chronic Lyme disease;~     chronic Lyme arthritis; seropositive control (are infected with the bacteria that causes Lyme~     disease but do not have disease symptoms); recovered control (have been sick with Lyme~     disease but were treated successfully and are currently well); control with multiple~     sclerosis (patients with multiple sclerosis); and healthy volunteers. Patients in the chronic~     Lyme disease category must be age 13 and above; all others must be age18 and above.~     Candidates will be screened with blood and urine tests.~      Participants will have a physical examination and the following tests:~      Blood tests Includes HLA-typing, a genetic test of immune system markers;~      Leukapheresis Collection of large numbers of white blood cells Whole blood is collected~     through a needle in an arm vein. The blood circulates through a machine that separates it~     into its components. The white cells are removed and the rest of the blood is returned to the~     body, either through the same needle used to draw the blood or through another needle in the~     other arm. (Alternatively, patients will 100 cc (about 7 tablespoons) of blood drawn.);~      Lumbar puncture (spinal tap) Collection of cerebrospinal fluid (CSF, fluid that bathes the~     brain and spinal cord). A local anesthetic is administered and a needle is inserted in the~     space between the bones in the lower back where the cerebrospinal fluid circulates below the~     spinal cord. A small amount of fluid is collected through the needle;~      Magnetic resonance imaging (MRI) of the brain Imaging of the brain using a strong magnetic~     field and radio waves instead of X-rays. During the scan, the patient lies on a table in a~     narrow cylinder containing a magnetic field. He or she can speak with a staff member via an~     intercom at all times during the procedure;~      Neuropsychologic testing;~      Some participants may also have a hearing test and urine collection.~      Participants whose test results are positive for Borrelia burgdorferi will be followed at NIH~     at intervals of 3 to 6 months until it is determined whether there is infection. Those who~     are infected will be offered treatment with the antibiotic ceftriaxone. Following treatment,~     patients will return to the NIH Clinical Center for follow-up visits 1 week after treatment~     and again at 3, 6 and 12 months. The lumbar puncture, hearing examination, blood and urine~     tests will be repeated at these visits to evaluate the response to treatment, and the~     leukapheresis will be repeated for research purposes. Patients whose MRI was abnormal during~     therapy will have a repeat MRI at the 3-month, 6-month and 1-year visits.~      All participants with chronic Lyme disease, chronic Lyme arthritis, seropositive controls and~     recovered controls may be reevaluated at intervals of 6 to 12 months.~   "
275066|NCT00000477|"~     To conduct a pilot study to determine whether lowering elevated serum cholesterol levels with~     3-hydroxy-3-methyl-glutaryl coenzyme A (HMG CoA) reductase inhibitors reduced mortality due~     to the sequelae of atherosclerotic cardiovascular disease in older men and women.~   "
274610|NCT00001535|"~     This study will test the safety and effectiveness of genetically altered T lymphocytes (white~     blood cells of the immune system) in reducing viral load in patients infected with the human~     immunodeficiency virus (HIV). The lymphocytes will have two genes inserted into them; a~     laboratory-manufactured anti-HIV gene designed to inhibit HIV reproduction (either the RevTD~     or Rev-TD-antiTAR gene), and a marker gene that will show whether or not the inserted genes~     have gotten into the cells.~      Identical twin pairs 18 years of age and older- one of whom is HIV-positive (infected with~     the human immunodeficiency virus) and the other HIV-negative (not infected) may be eligible~     for this study.~      All participants will have a complete medical history and physical examination, blood tests~     and a tetanus booster shot, if indicated. The non HIV-infected twin will then undergo~     lymphapheresis to collect lymphocytes. In this procedure, whole blood is collected through a~     needle placed in an arm vein. The blood circulates through a machine that separates it into~     its components. The lymphocytes are then removed, and the red cells and plasma are returned~     to the donor, either through the same needle or through a second needle placed in the other~     arm.~      The donor cells are grown in the laboratory for a few days, and then the new genes are~     inserted into them. The genetically altered cells are grown in the laboratory for several~     days until their numbers increase approximately a thousand-fold. They are then infused~     intravenously (through a vein) into the infected twin. These procedures-lymphapheresis, gene~     modification and infusion-will be repeated at approximately 2-month intervals up to four~     times.~      Each lymphocyte infusion takes about 60 minutes. The patient's vital signs (temperature,~     pulse, blood pressure and breathing) are monitored frequently during the infusion and hourly~     for 4 hours after the infusion. Blood samples are taken the day of the infusion, 3 days~     later, and then weekly to monitor the gene-modified cells, immune status, viral activity, and~     other factors. These tests may be done less often as the study progresses and more is learned~     about the safety of the infusions. The infusions are done on an outpatient basis unless side~     effects require that they be done in the hospital with post-infusion monitoring for at least~     24 hours.~      Patients will be followed for long-term effects of treatment monthly for the first 3 months,~     once a month for the next 9 months and yearly from then on.~      This study will contribute information about the use and side effects of gene therapy in HIV~     infection that may lead to new treatment strategies. A potential direct benefit to~     HIV-infected individuals participating in this study is reduced viral load; in laboratory~     studies, the RevTD and Rev-TD-antiTAR genes have inhibited HIV spread in the test tube.~     However, this is an early phase of study, and the likelihood of receiving this benefit is~     unknown.~   "
274611|NCT00001534|"~     The human heart is divided into four chambers. One of the four chambers, the left ventricle,~     is the chamber mainly responsible for pumping blood out of the heart into circulation.~     Hypertrophic cardiomyopathy (HCM) is a genetically inherited disease causing an abnormal~     thickening of the heart muscle, especially the muscle making up the left ventricle. When the~     left ventricle becomes abnormally large it is called left ventricular hypertrophy (LVH). This~     condition can cause symptoms of chest pain, shortness of breath, fatigue, and heart beat~     palpitations.~      This study is designed to compare the ability of two drugs (enalapril and losartan) to~     improve symptoms and heart function of patients diagnosed with hypertrophic cardiomyopathy~     (HCM).~      Researchers have decided to compare these drugs because each one has been used to treat~     patients with other diseases causing thickening of the heart muscle. In these other~     conditions, enalapril and losartan have improved symptoms, decreased the thickness of heart~     muscle, improved blood flow and supply to the heart muscle, and improved the pumping action~     of the heart muscle.~      In this study researchers will compare the effectiveness of enalapril and losartan when given~     separately and together to patients with hypertrophic cardiomyopathy (HCM).~   "
274612|NCT00001532|"~     This study is designed to evaluate the genetics involved in the development of lung disease~     by surveying genes involved in the process of breathing and examining the genes in lung cells~     of patients with lung disease.~      The study will focus on defining the distribution of abnormal genes responsible for processes~     directly involved in different diseases affecting the lungs of patients and healthy~     volunteers.~      Optional CT Sub-study~      The standard CT scan will be compared to the low dose radiation CT scan for the 150 subjects~     enrolled in the sub-study to assess the variation between the two techniques. Specifically,~     the quantitative computer aided detection of lung CT abnormalities from LAM can be compared~     to assess whether low radiation dose CT exams is an alternative to conventional CT to monitor~     disease~      status.~      This optional sub-study will be offered to up to 100 adult subjects with lung disease and up~     to 50 children age 9 and older with CF. Children will not be enrolled in the optional CT~     sub-study unless they have had a standard CT scan for medical purposes to use in comparison.~     One additional low dose radiation CT scan of the chest may be done as part of this sub-study~     when these subjects have their next annual CT scan.~   "
274613|NCT00001529|"~     Bone marrow transplants (BMT) are one form of treatment for disorders of the blood, including~     leukemia. However, because the procedure is often associated with potentially~     life-threatening reactions, it is usually reserved for patients with serious illnesses under~     the age of 60 years old.~      One serious reaction complicating bone marrow transplants is referred to as graft-versus-host~     disease (GVHD). GVHD is a potentially fatal incompatibility reaction. The reaction is caused~     by antigens found on the cells of the patient that are not present on the cells of the donor.~     The antigens are recognized by transplanted white blood cells (lymphocytes). These~     lymphocytes begin attacking the recipient s cells and tissues and may lead to death.~      In order to avoid GVHD, researchers have developed a technique using peripheral blood instead~     of bone marrow that allows transplantation of stem cells and removal of lymphocytes. Stem~     cells are the cells responsible for returning blood cell production to normal. Lymphocytes~     are the white blood cells that can cause GVHD.~      The technique requires two steps. In the first step blood cells are collected from donors who~     have received doses of a growth factor. The growth factor (granulocyte colony stimulating~     factor) is designed to increase the production of donor stem cells.~      In the second step white blood cell lymphocytes are removed from the collected blood, leaving~     only the stem cells.~      The main goal of this study is to develop and improve the method of processing cells that are~     collected after stimulation with growth factor (G-CSF), by removing the white blood cell~     lymphocytes which can cause graft-versus-host disease (GVHD) while keeping the stem cells~     necessary for healthy blood cell building. In addition, researchers are interested in~     studying whether giving G-CSF has an effect on lymphocyte function, which may influence the~     immune reactions occurring in bone marrow transplantation.~   "
274614|NCT00001526|"~     Uveitis refers to intraocular inflammatory diseases that are an important cause of visual~     loss. Standard systemic immunosuppressive medications for uveitis can cause significant~     adverse effects. Consequently, an effective treatment with a safer side effect profile is~     highly desirable.~      This pilot study has permitted enrollment of up to 12 adults with non-infectious intermediate~     or posterior uveitis who require treatments to maintain visual function. This extended~     protocol began with an evaluation of the safety and potential efficacy of intravenous (IV)~     daclizumab treatments for uveitis while reducing or eliminating standard medications~     commensurate with the standard of care. As subcutaneous (SC) daclizumab treatments become~     available, eligible participants will be offered continuing daclizumab treatments using the~     new SC formulation, though they may elect to remain on the IV treatments. If the therapeutic~     benefit is sustained using the SC formulation, maintenance therapy will continue as~     clinically indicated. Participants who repeatedly fail the SC therapy will be permitted to~     revert to the IV daclizumab regimen they previously used, or may exit the study as treatment~     failures. SC treatments begin with a short SC induction at 2 mg/kg followed by 1 mg/kg~     treatments on a 4-week schedule as the protocol originally specified. Participants will be~     monitored routinely when each dose is received and additionally will participate in~     pharmacokinetic studies to monitor SC formulation bioavailability.~      Daclizumab is a humanized anti-Tac monoclonal antibody (HAT, Zenapax) that interferes with~     inflammatory processes by its involvement with the interleukin 2 receptor (IL-2R). During the~     first 5 years of this study, only an IV product was available. The SC formulation is now~     available containing the same daclizumab drug product. Preliminary studies indicate that the~     SC formulation is well tolerated by normal control subjects and other autoimmune disease~     patients at repeated doses up to 2 mg/kg.~      The primary objectives are to examine the safety and potential efficacy of IV and later, SC~     daclizumab, while continuing to reduce other immunosuppressive medications commensurate with~     the standard of care. Primary safety outcomes are the discontinuation of study therapy due to~     reduced vision or the occurrence of adverse events. Secondary outcome measures include visual~     acuity and the grading of immunosuppressive medications, anterior chamber and vitreous cells,~     and vitreous haze.~   "
275067|NCT00000476|"~     To determine if digitalis had a beneficial, harmful, or no effect on total mortality in~     patients with clinical heart failure and sinus rhythm.~   "
274615|NCT00001524|"~     This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV~     infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day.~     However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased~     viral load, and even nerve damage that may not be reversible. This study will evaluate the~     efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore)~     for the healing of these sores.~      Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one~     or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be~     referred by a primary care physician who is managing their care, and must have HIV/AIDS~     status confirmed. Patients' HIV treatment regimen will not be altered and those receiving~     highly active therapy will not be excluded.~      Patients will be excluded if they are concurrently being treated for mucosal lesions~     (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals,~     or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation~     therapy for neoplasms; using concurrent acute therapy for opportunistic infections;~     concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to~     thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating~     females or those not practicing contraception according to FDA guidelines for thalidomide.~   "
274616|NCT00001522|"~     This study focuses on the way weight is gained. Individuals who gain weight primarily in~     their midsection (visceral weight) are at an increased risk for developing diabetes and high~     blood pressure.~      Research has shown that African Americans suffer more often from high blood pressure,~     diabetes (non-insulin dependent), and heart disease than Caucasian Americans. These~     conditions lead to significant numbers of deaths and diseases associated with and made worse~     by obesity.~      African American women in particular suffer from obesity and the associated conditions of~     obesity more than any other race or gender. However, it is unknown if the conditions seen in~     African American women are a result of the obesity or differences in their insulin~     sensitivity, glucose disposal, or fat metabolism.~      This study will compare body composition, total and resting energy expenditure, and glucose~     disposal of obese African American and Caucasian children and of non-obese children of obese~     African American and Caucasian parents, to characterize the timing and nature of factors that~     may contribute to the prevalence of obesity and its complications.~      Patients participating in this study will be followed for 15 years and be evaluated every 5~     years during the study.<TAB>~   "
274617|NCT00001521|"~     This study was developed to determine if a combination of four drugs (flutamide,~     testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in~     children with congenital adrenal hyperplasia.~      The study will take 60 children, boys and girls and divide them into 2 groups based on the~     medications given. Group one will receive the new four- drug combination. Group two will~     receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and~     fludrocortisone).~      The boys in group one will take the medication until the age of 14 at which time they will~     stop taking the four drug combination and begin receiving the standard treatment for~     congenital adrenal hyperplasia. Girls in group one will take the four drug combination until~     the age of 13, at which time they will stop and begin receiving the standard treatment for~     congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until six~     months after their first menstrual period.~      All of the children will be followed until they reach their final adult height. The~     effectiveness of the treatment will be determined by measuring the patient's adult height,~     body mass index, and bone density. <TAB>...~   "
274618|NCT00001516|"~     This study will evaluate the use of the personal computer (PC) in occupational therapy. The~     results of the study will help occupational therapists develop improved treatment activities~     using PCs.~      Patients enrolled in various NIH clinical trials who are referred for occupational therapy~     may be eligible for this study. Each patient will have at least four computer sessions within~     6 months. They will use the PC to achieve goals they set for themselves-for example, to build~     work skills, improve concentration, or simply have fun. At the end of each session, the~     occupational therapist will interview the patient, asking, for example, about the goal of the~     session and what may have occurred during the session to make it more helpful or less~     helpful. The interviews will be tape recorded and used to help determine how computers may be~     used most therapeutically.~   "
274619|NCT00001515|"~     This study will evaluate a new technique for examining the air passages of the lungs called~     virtual bronchoscopy. It involves using computed tomography (CT) images of the chest to~     generate a 3-dimensional model of the walls of the trachea and bronchi (airway passages).~     This non-invasive method lets doctors see small masses and areas of narrowing in the passages~     without having to do surgery or pass a tube through them.~      Patients with diseases of the air passages who are enrolled in an NIH clinical trial may~     participate in this study, which requires having a CT scan. The patient lies on a table that~     slowly slides into a hole in a donut-shaped X-ray machine (the scanner). Patients may have to~     hold their breath several times during the procedure. Some patients may be given an injection~     of a contrast agent through a catheter (thin tube) placed in an arm vein to improve~     visibility of abnormalities. Patients may also be asked to breathe oxygen through nasal~     prongs to allow them to hold their breath longer. The procedure usually takes 15 to 20~     minutes.~   "
274631|NCT00001483|"~     This study will compare the effectiveness of relatively new antidepressants which have~     different mechanisms of action.~      Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway.~      Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI).~      Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake~     inhibitor.~      Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are~     presently taking medication to prevent the symptoms of the disease (prophylactic treatment),~     but have had breakthrough episodes of depression despite taking their medication.~      Patients will receive any one of the three antidepressant medications as noted above plus a~     placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in~     addition to their regular medication for bipolar disorder. All of the doses will be~     calculated as effective for the treatment of a unipolar major depressive disorder. The~     patient will continue receiving the medication for ten weeks.~      The effectiveness of the drug treatment will be measured by using three different scales;~        1. Inventory for Depressive Symptoms - Clinicians form (IDS-C)~        2. Clinical Global Impression scale(CGI-BP)~        3. Life Charting Methodology (LCM)~      Patients who do not respond to their medication within ten weeks from the beginning of the~     study will be considered as non-responders and be offered the opportunity to start the study~     again, taking one of the two remaining medications. For example, if a patient was assigned to~     take Wellbutrin but it was ineffective, he/she could re-enter the study and be given either~     Zoloft or Effexor.~      Patients that do respond in the first ten weeks of the study will be eligible to continue~     taking the medication for one year to assess the long term effectiveness of the drug on~     preventing episodes of depression and to assess for any possible differential induction of~     mania.~   "
274620|NCT00001512|"~     The idiotype of the immunoglobulin on a given B cell malignancy (Id) can serve as a clonal~     marker, and a previous pilot study in lymphoma patients has demonstrated that autologous Id~     protein can be formulated into an immunogenic, tumor specific antigen by conjugation to a~     carrier protein (KLH) and administration with an emulsion-based adjuvant. The goals of~     vaccine development in the current study are to develop vaccines: 1) with improved potency~     and 2) which are more effective at inducing cell-mediated immune responses. The selection of~     GM-CSF as the immunological adjuvant is a direct extension of our laboratory studies in~     small animal models demonstrating that GM-CSF can enhance the potency of the prototype Id-KLH~     vaccine by augmenting almost exclusively the cellular arm of the immune response.~      The objectives of this study are: 1) to evaluate cellular and humoral immune responses~     against the unique idiotype of the patient's lymphoma and 2) to evaluate the ability of the~     Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination~     or molecular examination (polymerase chain reaction amplification of the rearranged bcl-2~     oncogene).~      The goal of this study is to treat previously untreated patients with follicular lymphomas to~     complete remission or minimal residual disease with ProMACE chemotherapy. Three to six months~     after completion of chemotherapy, in an effort to reduce the relapse rate (by eradicating~     microscopic disease resistant to chemotherapy), patients will receive an autologous Id~     vaccine administered in combination with GM-CSF. Id-KLH (0.5 mg) is administered~     subcutaneously. GM-CSF is administered subcutaneously locally with the vaccine on the day of~     vaccination and for the three consecutive days following vaccination as close to the initial~     vaccination site as possible at one of two doses (patients are randomized to either a high or~     low dose, 500 or 100 micrograms/m2).~      We plan to accrue 42 patients. Twenty-nine patients have been enrolled. Sixteen patients have~     entered and/or completed the vaccination phase. Patients have demonstrated significant~     lymphoproliferative responses specific for autologous idiotype of a magnitude which is~     significantly greater than previously observed.~   "
274621|NCT00001507|"~     This study will evaluate the effectiveness of combination chemotherapy with paclitaxel~     (Taxol) and cyclophosphamide (Cytoxan), followed by high-dose melphalan and etoposide for~     treating inflammatory breast cancer. Patients also receive infusions of their own previously~     collected progenitor cells (primitive cells that can make new cells to replace ones destroyed~     by chemotherapy).~      Patients 18 years of age or older with stage IIIB inflammatory breast cancer that has not~     metastasized (spread beyond the breast) may be eligible for this study. Candidates are~     screened with a medical history and physical examination, blood and urine tests, and chest~     x-ray. They have computed tomography (CT) of the head, chest, abdomen and pelvis as well as a~     bone scan to determine the extent of disease, and a nuclear medicine scan called MUGA to~     examine the heart's pumping ability. They may receive a rehabilitation medicine evaluation.~      Participants undergo the following tests and procedures:~        -  Central venous line placement: Patients have a central venous line (plastic tube) placed~          into a major vein in the chest before beginning treatment. The line remains in the body~          throughout treatment and is used to give chemotherapy and other medications and to~          withdraw blood samples. The line is usually placed under local anesthesia in the~          radiology department or the operating room.~        -  Chemotherapy: Patients receive two or more cycles of paclitaxel and cyclophosphamide.~          Paclitaxel is given intravenously (I.V., through a vein) for 72 hours using a portable~          pump. Cyclophosphamide is given daily for 3 days I.V. over 1 hour. The cycles may be 28~          days apart. A drug called Mesna is given with this treatment to protect the bladder from~          irritation from cyclophosphamide. Patients who have not previously been treated with~          doxorubicin (Adriamycin) may receive a maximum of four cycles of doxorubicin and~          cyclophosphamide by vein on a single day during each cycle, with cycles 21 days apart.~          When all the paclitaxel/cyclophosphamide cycles are completed, patients receive~          melphalan and etoposide, both drugs I.V. over 1 to 8 hours for three consecutive days.~        -  G-CSF treatment: After each paclitaxel/cyclophosphamide cycle and after the~          melphalan/etoposide treatment, patients are given a drug called G-CSF. G-CSF, injected~          under the skin, stimulates production of infection-fighting white blood cells.~        -  Apheresis: This is a procedure to collect progenitor cells for later reinfusion. For~          this procedure, blood is collected through a catheter (plastic tube) placed in an arm~          vein. The blood is circulated through a cell-separating machine, where the white cells,~          including the progenitor cells, are extracted, and the red cells are returned to the~          patient through another catheter in the other arm. Apheresis is done after each of two~          cycles of paclitaxel/cyclophosphamide.~        -  Progenitor cell transplant: Progenitor cells are reinfused after melphalan/etoposide~          treatment.~        -  Glucose infusion: A salt solution with chemically modified glucose is infused I.V. over~          a period of from 12 to 48 hours, with subsequent donation of blood cells for blood and~          immune system studies. Patients have a maximum of two glucose infusions, separated by at~          least 3 months.~        -  Tumor biopsy: Some patients have a biopsy of their tumor (removal of a small piece of~          tumor tissue for microscopic study) before starting chemotherapy.~        -  Blood tests: Blood is drawn frequently to monitor safety and treatment response, and for~          research purposes.~        -  Dental consultation: Some patients may have a dental consultation before the progenitor~          cell transplant.~   "
274622|NCT00001506|"~     This is a training, natural history of disease, and screening protocol for the evaluation,~     treatment and follow-up of patients with dermatologic diseases and systemic diseases with~     cutaneous manifestations. Patients enrolled in this protocol will be evaluated and treated~     according to generally available, standard procedures and therapeutic modalities. Samples of~     blood and skin will be studied by routine and specialized investigative methods to establish~     these patients' diagnosis, response to treatment, and/or disease progression.~   "
274623|NCT00001505|"~     Background:~      -This protocol is concerned with the acquisition of blood, skin, or mucosal samples from~     healthy volunteers or patients with selected skin diseases to support the basic science and~     clinical research activities of the Dermatology Branch and other intramural Laboratories and~     Branches at the NIH Clinical Research Center.~      Objectives:~      (Primary)~      -To allow collection of blood, skin, or mucosal samples from healthy volunteers or patients~     with selected skin or systemic diseases as needed to support the research activities of our~     Branch and other Laboratories and Branches.~      Eligibility:~        -  Healthy individuals (including employees and other patients) and patients with selected~          skin or other diseases, including individuals of both genders and all racial/ethnic~          groups.~        -  Patient volunteers must be willing to undergo blood drawing and/or skin/mucosal~          biopsies.~      Design:~      -This is dependent upon the particular investigation for which these samples are needed.~   "
274624|NCT00001504|"~     This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic~     acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral~     9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the~     regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the~     study if medically appropriate.~   "
274625|NCT00001503|"~     This protocol is to provide follow-up medical/surgical visits for DCS patients who are long~     term survivors and may not currently be a participant entered on an active research protocol.~     No investigational treatments or standard treatments will be administered on this protocol.~   "
274626|NCT00001500|"~     We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and~     other complex human characteristics. The main areas of interest are tobacco smoking, excess~     alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. The~     subjects will be adult male and female probands who display one or more of the phenotypes of~     interest together with their brothers, sisters and parents. Information on tobacco and~     alcohol use, psychological and personality traits, sexual behavior, HIV status and~     progression, and other characteristics with possible genetic components will be obtained~     through structured interviews and questionnaires. DNA will be prepared from blood samples and~     typed for a series of candidate genes chosen for function and for random polymorphic markers.~     By correlating the genotypic and phenotypic information, we hope to identify individual loci~     that interactively contribute to many different aspects of human health and disease.~   "
274627|NCT00001496|"~     Women who are at high risk for breast cancer, either because of linkage to high risk breast~     and ovarian cancer families, or because of a carcinoma in the opposite breast, will be~     studied. Women will have a physical examination and mammography to ensure that no breast~     abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal~     breast tissue. Short-term cell cultures will be established from this tissue and early~     passages of the short-term cell lines will be stored. A bank of high risk normal mammary~     epithelial cells will be established. To further characterize the mammary epithelial cells in~     this population of women, cell cultures will subsequently be analyzed for their growth and~     metabolic properties, sensitivity to chemopreventive agents, steroid receptor~     characteristics, oncogene expression and regulation, and genetic changes.~   "
274628|NCT00001491|"~     Fabry's disease a genetic disorder (X-linked recessive) due to the absence of the enzyme~     ceramidetrihexosidase. The disease is characterized by abnormal collections of glycolipids in~     cells (histiocytes) within blood vessel walls, tumors on the thighs, buttocks, and genitalia,~     decreased sweating, tingling sensations in the extremities, and cataracts. Patients with~     Fabry 's disease die from complications of the kidney, heart, or brain.~      The purpose of this study is to measure levels of a protein marker (PGP 9.5) in the skin,~     blood, and fluid surrounding the brain and spinal cord (CSF) in patients with Fabry's~     disease. In addition the study will attempt to determine if levels of the protein are~     directly related to the severity of disease in the nervous system.~      PGP 9.5 protein levels will be measured in normal volunteers and patients with other diseases~     of the nervous system then compared to the levels recorded in patients with Fabry's disease.~      This research study is designed to improve the understanding of Fabry's disease. Patients~     participating in it will not directly benefit from it. However, knowledge gained as a result~     of this study may contribute to the development of effective therapies for Fabry's disease.~   "
275068|NCT00000475|"~     To assess the impact of a multidisciplinary treatment program on three-month readmission-free~     survival in elderly congestive heart failure patients.~   "
274632|NCT00001481|"~     Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and~     progesterone.~      The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has~     been extensively reported. While there has been much speculation about possible biologically~     based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary~     results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women~     with menstrual cycle related mood disorder, but not controls, experience mood disturbances~     during exogenous replacement of physiologic levels of gonadal steroids. The present protocol~     is designed to create a scaled-down hormonal milieu of pregnancy and the puerperium in~     order to determine whether women who have had a previous episode of postpartum major~     effective episode will experience differential mood and behavioral effects compared with~     controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the~     prolonged exposure to gonadal steroids that is associated with mood symptoms.~     Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then~     rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition.~     This will be accomplished by administering estradiol and progesterone to women who are~     pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks,~     administration of gonadal steroids will be stopped in one group of patients and controls, and~     a sudden decline in the plasma hormone levels will be precipitated. Another group will be~     maintained on supraphysiologic levels of estrogen and progesterone for an additional month.~     Outcome measures will include mood, behavioral and hormonal parameters as well as response to~     o-CRH (a separate protocol done in collaboration with NICHD).~   "
274633|NCT00001480|"~     The purpose of this study is to evaluate people with mild memory problems, those with~     dementia, those at risk for developing Alzheimer's disease (AD), and healthy volunteers to~     identify markers of AD before the changes that occur with the disease begin.~      The origin and markers of progression for Alzheimer's disease (AD) are relatively obscure.~     Despite increased understanding of the underlying biology of AD, its clinical diagnosis is~     still made only after progressive cognitive decline; definitive diagnosis is confirmed at~     autopsy. This study will examine biomarker changes over time in a distinct cohort of people~     with an increased risk of developing AD. The study will also identify and track biological~     changes that occur with progressive dementia and compare those changes to the known cognitive~     and emotional disturbances that characterize AD.~      Individuals with a first-degree relative with AD will be recruited into an at-risk cohort.~     They will be followed and compared to a group of healthy volunteers for a minimum of 8 years.~   "
274634|NCT00001476|"~     This protocol will follow patients who participated in NIAID's study Gene Therapy Approach~     for Chronic Granulomatous Diseases (95-I-0134). No further gene therapy treatments will be~     given under this protocol. However, because gene therapy is a new technology and involves a~     permanent change in the genetic code of some cells, patients who have had this treatment~     require long-term health monitoring.~      Participants will be asked to provide updated address and telephone information and the names~     of two contact persons, such as siblings or friends. Patients will be seen about once a year~     at the NIH Clinical Center to provide an update on their health status and donate a small~     blood sample (about 2 teaspoons), which will be frozen and stored. If a patient acquires a~     serious illness, such as cancer, his or her stored blood will be tested; another of blood or~     tissue sample may also be requested for further study. If a patient develops a medical~     problem that is thought possibly to be related to gene therapy, the illness will be~     investigated. The annual follow-up visits will continue indefinitely or until the patient~     declines to continue participation.~      Participants may also agree to store some of their blood future research on chronic~     granulomatous diseases and other medical conditions. Stored samples may be labeled with a~     code, such as a number, that only the study team can link with the patient. Any identifying~     information about the patient will be kept confidential as is permitted by law.~   "
274635|NCT00001475|"~     Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an~     extension phase of this study in which the drug prednisone will be eliminated from the~     treatment regimen. Prednisone is associated with avascular necrosis, a condition that has~     been found in a number of patients in this study. Also, certain patients in this protocol may~     receive future interleukin-2 treatment cycles at home. Home administration of IL-2 injections~     involves less frequent data and safety monitoring and no medical evaluations at the Clinical~     Center except at the beginning of each cycle.~      To be eligible for home administration of IL-2, patients must:~        -  Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1~          year of treatment on the protocol, with at least two well-tolerated outpatient cycles at~          a stable dose.~        -  Have a history of tolerable side effects while receiving IL-2 without frequent medical~          interventions, intravenous fluid replacement or dose reductions.~        -  Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of~          the last two outpatient cycles.~        -  Have a strong relationship with a private physician or health-care provider who has been~          involved in the patient's care and is willing to help supervise the patient's care~          during each home IL-2 cycle.~        -  Live in a home with easy telephone access and have proved reliable in responding to~          telephone calls from clinic staff.~        -  Give the clinic staff contact information for a close friend or relative who will agree~          to serve as a caregiver during each home cycle, providing the patient non-medical~          assistance and checking on his or her condition daily.~        -  Have reasonable access to emergency medical services and a nearby medical facility.~        -  Have proved reliable and consistent in using sterile technique, reconstituting IL-2~          vials and administering subcutaneous IL-2 injections.~        -  Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of~          their normal protocol participation.~        -  Have access to a home weight scale and be able to weigh themselves each day for safety~          monitoring.~      Participants will receive IL-2 cycles on the same schedule they followed in their original~     protocol participation. They will be seen at the Clinical Center at regularly scheduled~     follow-up visits between cycles and for a medical evaluation and blood drawing before the~     start of each cycle to determine the safety of administering the cycle. During the home~     cycle, the patient's case manager or other team member will place monitoring telephone calls~     on days 2 and 4 of the cycle and again a week later. The timing and number of these calls may~     change depending on the findings of ongoing assessments of their usefulness. Patients will be~     required to notify the study team promptly of any complications or other problems that~     develop with therapy.~   "
274636|NCT00001474|"~     This study is designed as a randomized, open trial of intermittent continuous infusions of~     Interleukin-2 in HIV seropositive patients with a CD4 cell count between 200 and 500~     cells/mm(3). The goal of the study is to determine the optimal duration of each infusion, and~     the optimal interval between infusions. Thirty-six patients will be randomized to 3 groups:~     Group A will be the control group with a regimen of five day infusions of IL-2 every eight~     weeks; Group B will receive IL-2 infusions every eight weeks, however the duration of each~     infusion will be determined by parameters reflecting T cell proliferation, with~     discontinuation of each infusion at a point when the response appears to be maximized; Group~     C will receive five day infusions of IL-2; however the interval between infusions will be~     determined by the response seen to the prior infusion, with the goal of administering~     infusions while the CD4 cell count remains above baseline from the prior infusion. The dose~     of interleukin-2 to be used will be 9 MIU by continuous infusion daily. All patients will be~     evaluated at the NIH at least every 4 weeks, and at that time safety labs and immune studies~     will be performed. In addition, patients in Groups B and C will undergo a laboratory~     evaluation weekly, at which time immune parameters, including CD4 number and percent,~     spontaneous blast transformation, soluble IL-2 receptor levels, and viral parameters,~     including branched DNA assay and p24 antigen, will be determined. The study duration will be~     approximately one year.~   "
275069|NCT00000474|"~     To evaluate the long-term effect of reduction of alcohol intake on blood pressure in moderate~     but non-dependent drinkers with mild hypertension or high normal blood pressure.~   "
274637|NCT00001473|"~     This study will evaluate the safety and effectiveness of a staged approach to therapy for~     Wegener's granulomatosis and other systemic vasculitides using prednisone plus~     cyclophosphamide followed by methotrexate. Vasculitides involve inflammation of blood vessels~     (vasculitis) that may affect the brain, nerves, eyes, sinuses, lungs, kidneys, intestinal~     tract, skin, joints, heart and other sites. Standard treatment with prednisone and~     cyclophosphamide is very effective, but has significant toxicity (adverse side effects).~     Methotrexate is also an effective treatment and is less toxic, but it is associated with a~     higher rate of disease recurrence and has not been used in patients with severe lung or~     kidney disease. Staged therapy using cyclophosphamide first and then methotrexate may provide~     better results for overall safety and effectiveness.~      Patients 10 to 80 years of age with active Wegener's granulomatosis, polyarteritis nodosa or~     a related systemic vasculitis may be eligible for this study. Candidates will be screened~     with a medical history and physical examination, blood and urine tests, chest X-ray,~     electrocardiogram (EKG) and pulmonary function tests. Other procedures, such as biopsies,~     will be done only as medically indicated.~      Participants will be treated initially with 1 milligram/kilogram body weight of prednisone~     once a day and 2 to 4 mg/kg cyclophosphamide once a day. If the disease improves~     significantly, prednisone will be gradually reduced and stopped, and if remission is~     achieved, cyclophosphamide will be stopped. Methotrexate will then be started at 0.3 mg/kg~     body weight once a week and then increased to 0.5 mg/kg after 2 to 4 weeks. Methotrexate~     therapy will continue for at least 2 years. If at the end of 2 years the disease remains in~     remission, the methotrexate will be gradually reduced and stopped. If, on the other hand,~     active disease recurs during methotrexate treatment, the therapy will be changed. The new~     choice of treatment will depend on the severity of recurrence, pre-existing medical~     conditions, and previous adverse reactions to prednisone, cyclophosphamide and methotrexate.~      Patients will be seen periodically for a physical examination and blood tests to evaluate~     disease activity, response to therapy and drug side effects. X-rays will be done as medically~     indicated. Evaluations will be scheduled once a month until the patient has been on~     methotrexate for 3 months and then every 3 months for the next 18 months. Patients whose~     disease remains in remission at that time and are off all medications will be seen every 6~     months for another 4 visits.~   "
274638|NCT00001471|"~     This study will examine tissue from the tonsils, lymph nodes and large bowel of HIV-infected~     patients to investigate changes in viral load and certain white blood cells during treatment.~      Normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this~     study. Candidates will be screened with a medical history, physical examination, blood and~     urine tests and possibly an electrocardiogram (EKG). Blood tests may include HLA typing, a~     genetic test of immune system markers.~      Participants may undergo the following procedures:~        -  Blood tests (patients and volunteers)~        -  Biopsies The frequency of biopsies for given patients may vary, depending on their~          specific therapy. Typically, biopsies are done at a single time, or for patients~          starting a new therapy, biopsies could be performed before starting therapy, during~          therapy and possibly after completion of therapy.~        -  Tonsil biopsies (patients and volunteers) Volunteers will have one tonsil biopsy.~          Patients will have no more than six tonsil biopsies, with no more than three in a 10-day~          period. The biopsy is done by an ear, nose and throat specialist as an outpatient~          procedure. The tonsils are numbed with a local anesthetic, and one to four pieces of~          tissue are extracted.~        -  Lymph node biopsies (patients only) Patients will have no more than four lymph node~          biopsies, performed no more frequently than once a month. The biopsy is done by a~          surgeon and may require a 2- to 3-day hospital stay. The skin above the lymph nodes is~          numbed with a local anesthetic, an incision is made and the tissue is removed.~          Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is~          withdrawn through a special needle injected into the site.~        -  Intestinal biopsies (patients and volunteers) Volunteers will have one intestinal biopsy~          procedure. Patients may have up to six intestinal biopsy procedures, each separated by~          at least 10 days. This is done by a gastroenterologist as an outpatient procedure. A~          flexible tube (sigmoidoscope or colonoscope) with a light and special lens at the tip is~          inserted into the rectum and large bowel. Wire instruments passed through the tube are~          used to extract small tissue samples.~        -  Bronchoalveolar lavage (BAL; patients and volunteers) Volunteers and patients will~          undergo bronchoscopy in which a flexible tube (bronchoscope) with a light and special~          lens at the tip is inserted through the nose or mouth into the lungs, and the lining of~          the lung is sampled by washing the airways with small amounts of saline. The procedure~          is performed by a pulmonologist or critical care specialist, usually as an outpatient.~   "
274639|NCT00001469|"~     Molecular approaches to the understanding of human neoplastic disease have revealed that~     multiple genetic alterations are an essential component of tumorigenesis. Both germline and~     somatic genetic alterations can be involved in the malignant transformation of normal cells.~     Identification of the genes involved in neoplastic transformation has been approached through~     the molecular analysis of sporadic cancers and the genetic study of families with an~     inherited predisposition for cancer. The interplay of these two approaches has led to the~     characterization of genes such as the retinoblastoma (Rb) gene, the p53 gene and the~     adenomatous polyposis coli (APC) gene that are all involved in the development of both~     hereditary and non-hereditary forms of cancer. Inherited mutations in such genes predispose~     affected families to hereditary cancer syndromes, affording an opportunity to identify~     genetic lesions that also cause the more common sporadic cancers.~      Prostate cancer (PRCA) is the most common cancer diagnosed (1999 estimate 179,300 cases) and~     the second leading cause of cancer mortality (1999 estimate 37,000 deaths) in men in the~     United States. Family history is the single strongest risk factor currently known for~     prostate cancer. This raises the possibility that heritable genetic factors may be involved~     in the development of this disease in a subset of men. The genetic contribution to diseases~     of complex origin such as cancer is often most salient in families of early onset cases.~     Therefore, prostate cancer inheritance following a simple Mendelian pattern may be identified~     in the families of probands with early-onset cases. Common susceptibility alleles of small~     effect may be detectable in families with later-onsent and/or less strong family history of~     PRCA or in case-control data.~   "
274640|NCT00001467|"~     The purposes of this study are to 1) identify the genes responsible for certain immune~     disorders, 2) learn about the medical problems they cause, and 3) learn how to predict who is~     likely to develop these disorders and what the risk is of passing them on to children. The~     immune system is the body s defense system. Some immune deficiencies impair a person s~     ability to fight infections; others render a person susceptible to allergies, or to~     autoimmune diseases such as lupus or arthritis, in which the immune cells (white blood cells)~     attack and destroy the body s own tissues.~      Patients with immune disorders known or suspected to have a genetic basis and their family~     members may enroll in this study. Eligibility will be determined by a review of the patient s~     medical records and family medical history. Participants will provide a small blood sample~     for genetic (DNA) and white blood cell analysis. Gene samples (but not white blood cells) may~     also be obtained by mouth brushing or skin biopsy. For the mouth brushing, a small brush is~     rubbed against the inside of the cheeks for 1 minute to wipe off some cells. For the skin~     biopsy, a small circle of skin (about 1/8 inch) is removed under local anesthetic. Pregnant~     women may be asked to provide a fetal sample (amniotic fluid cells or chorionic villus~     sample). All samples will be used for immune or genetic studies of the family s immune~     disorder.~      If test results show a specific genetic variation responsible for the family s immune~     disorder, a report will be sent to the patient s doctor or genetic counselor, who will~     discuss the implications for the family. NIH researchers and genetic counselors will also be~     available to explain results and answer questions. Information will not be available in the~     case of disorders that cannot yet be linked to a specific genetic abnormality.~      Information from this study will increase knowledge about the immune system and what causes~     immune deficiencies. Participants may also learn the underlying cause of an immune disorder~     that affects them or someone in their family information may be useful in guiding treatment~     and in making decisions regarding family planning.~   "
274641|NCT00001465|"~     Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically affecting~     women of childbearing age. Currently, there is no effective therapy for the disease and the~     prognosis is poor.~      This study is designed to determine the disease processes involved at the level of cells and~     molecules, in order to develop more effective therapy.~      Researchers intend to identify the proteins and genes that contribute to the process of lung~     destruction in affected individuals.~   "
274859|NCT00000395|"~     This study looks at how the arthritis drug methotrexate works in low doses to treat~     rheumatoid arthritis. (High doses of methotrexate are used to treat some types of cancer.)~     Methotrexate blocks the action of the B-vitamin known as folic acid. We are studying the~     biochemical reactions affected by this vitamin because we think that blocking many of these~     reactions may be necessary for methotrexate to work in treating rheumatoid arthritis. Through~     these studies, we hope to gain a better understanding of how this drug and related drugs work~     as treatments for arthritis.~   "
274642|NCT00001464|"~     Patients with lung disease experiencing difficulty breathing can be treated with oxygen~     therapy. This involves the delivery of extra oxygen by a face-mask or through small tubes~     placed in the nose called nasal prongs. This extra oxygen can have concentrations as high as~     100% pure oxygen. The concentration of oxygen in normal air is only 21%. The high~     concentration of oxygen can help to provide enough oxygen for all of the organs in the body.~     Unfortunately, breathing 100% oxygen for long periods of time can cause changes in the lungs,~     which are potentially harmful. Researchers believe that by lowering the concentration of~     oxygen therapy to 40% patients can receive it for longer periods of time without the risk of~     side effects.~      This study is designed to evaluate the effects of oxygen therapy at 100% and 40% for 12 18~     hours on the lungs of normal volunteers. Results of this study will help to determine if~     levels of oxygen therapy currently accepted as being safe may actually be damaging to the~     lungs.~   "
274643|NCT00001460|"~     There is an important need to maintain clinical skills, provide quality training and~     expertise, and provide an environment that stimulates ideas for clinical research.~      This study permits inpatient evaluation and management of patients with heart disease who do~     not qualify to participate in studies currently being conducted by the Cardiology Branch of~     the National Heart, Lung, and Blood Institute.~   "
274644|NCT00001458|"~     An important mission of the National Institutes of Health (NIH) is to develop and carry out~     research studies designed to improve understanding of disease processes and treatments.~      Clinical research continues to become more focused on specific diseases and the signs and~     symptoms of diseases in specific groups of people and patients.~      This study is designed to permit inpatient evaluation and care of patients with heart disease~     who do not qualify to participate in research studies being conducted by the Cardiology~     Branch of the National Heart, Lung, and Blood Institute (NHLBI). These patients are valuable~     to the Cardiology Branch of the NHLBI because they help to improve training and experience of~     its researchers.~   "
274645|NCT00001457|"~     Chronic hepatitis B is a disease of the liver caused by the hepatitis B virus. It affects~     nearly 1 million Americans. Approximately 25% of patients with chronic hepatitis B will~     develop liver cirrhosis and 5% of patients will develop liver cancer.~      Presently, two medications have been shown effective in the treatment of hepatitis B:~     lamivudine and alpha interferon. Alpha interferon (an antiviral drug that acts through the~     immune system) is given by injection once daily or three times a week for four to six months.~     Lamivudine (also known as 3-thiacytidine: 3TC) is an antiviral medication given as a pill~     once a day for twelve months. These treatments have been known to provide long-term~     improvement in one third of patients receiving them.~      In previous research, the drug lamivudine was shown to stop the growth of the hepatitis B~     virus and to lead marked decreases in the levels of hepatitis B virus and to improvements in~     the disease in 50 to 70% of patients. However, once lamivudine therapy was discontinued the~     virus returned to levels noted before the therapy began. In those studies lamivudine was~     given for 3 to 12 months then discontinued. This study will investigate the safety and~     effectiveness of long-term therapy with lamivudine.~      This study will select 60 patients diagnosed with hepatitis B. After a thorough medical~     examination and liver biopsy, subjects will be given lamivudine. The drug will be taken by~     mouth in tablet form (100 mg) once a day for up to 5 years. Subjects will undergo regular~     check-ups and after 1 year of therapy be admitted to the Clinical Center for another medical~     examination and liver biopsy to assess progress. Patients who have benefitted from the~     therapy will continue taking the medication for up to 5 years. A third liver biopsy will be~     done during the last year of treatment. The effectiveness of lamivudine will be determined by~     whether levels of hepatitis B virus decrease in the blood, whether liver enzymes improve, and~     whether inflammation and scarring decreases in the liver biopsies.~   "
274646|NCT00001456|"~     Hermansky-Pudlak Syndrome (HPS) is an inherited disease which results in decreased~     pigmentation (oculocutaneous albinism), bleeding problems due to a platelet abnormality~     (platelet storage pool defect), and storage of an abnormal fat-protein compound (lysosomal~     accumulation of ceroid lipofuscin).~      The disease can cause poor functioning of the lungs, intestine, kidneys, or heart. The major~     complication of the disease is pulmonary fibrosis and typically causes death in patients ages~     40 - 50 years old. The disorder is common in Puerto Rico, where many of the clinical research~     studies on the disease have been conducted. Neither the full extent of the disease nor the~     basic cause of the disease is known. There is no known treatment for HPS.~      The purpose of this study is to perform research into the medical complications of HPS and~     begin to understand what causes these complications. Researchers will clinically evaluate~     patients with HPS of all ethnic backgrounds. They will obtain cells, blood components~     (plasma), and urine for future studies. Genetic tests (mutation analysis) to detect~     HPS-causing genes will also be conducted.<TAB>~   "
274647|NCT00001454|"~     Endometrium is the lining of the uterus. It is where the fertilized egg normally implants~     during pregnancy.~      This study was designed to better understand the way(s) that female sex hormones (estrogen~     and progesterone) cause the uterus to grow and develop. It is known that these hormones are~     necessary to prepare the uterus for pregnancy, but the way the hormones work is unknown.~      Researchers would like to identify the genes that are affected by female sex hormones by~     using a variety of tests (in situ hybridization, immunohistochemistry, and culture of human~     endometrium).~      Researchers will select women who have regular monthly menstrual cycles and study them for~     two cycles;~        1. <TAB>The first cycle (PRE-BIOPSY CYCLE) will include daily measurements of the patient's~          body temperature and progesterone measurements during the last 14 days (luteal phase) of~          the menstrual cycle.~        2. <TAB> The second cycle (BIOPSY CYCLE) will include measurements of urinary luteinizing~          hormone (LH) to determine the day of the LH surge. Luteinizing hormone is the hormone~          that causes the ovary to release the developed egg. Ovarian ultrasounds will be~          performed before the biopsy to determine development of the egg. Blood tests will be~          taken on the day of the biopsy to have an overall idea of the hormones circulating in~          the patient's blood. An endometrial biopsy will be taken at one of three possible times~          to identify endometrial products under conditions of estrogen, estrogen/progesterone, or~          steroid hormone withdrawal.<TAB>~   "
274655|NCT00001430|"~     This is a randomized study of combination chemotherapy (EPOCH II) versus EPOCH II and~     immunotherapy with peripheral blood stem cells (PBSC) and IL-2 in patients with relapsed~     Hodgkin's and non-Hodgkin's lymphomas, and untreated patients with low-grade non-Hodgkin's~     lymphomas. The chemotherapy entails the administration of multiple cycles of infusional~     doxorubicin, etoposide and vincristine chemotherapy (total of 3), alternating with cycles of~     high-dose cyclophosphamide (3 cycles). Patients will be randomized, on a 2:1 basis, to either~     receive only chemotherapy or to undergo a PBSC harvest with PBSC reinfusion and IL-2~     following the last cycle of chemotherapy. In all patients, immunological monitoring for~     NK/LAK activity, T cell number and function will be performed. The therapy is specifically~     targeted for patients who would be candidates for high-dose chemotherapy with stem cell~     support.~   "
275070|NCT00000473|"~     To determine whether a dietary supplement of n-3 polyunsaturated fatty acids (PUFAs) derived~     from fish oil would decrease the restenosis rate in patients undergoing percutaneous~     transluminal coronary angioplasty (PTCA).~   "
274648|NCT00001453|"~     Patients with Cushing disease have hormone producing tumors in their pituitary gland. Often~     these tumors are so small they cannot be detected by magnetic resonance imaging (MRI). The~     inferior petrosal sinuses are small veins that drain the blood from the pituitary gland. By~     taking a small sample of blood from these sinuses, doctors can differentiate a small tumor in~     the pituitary gland from other tumors in the body producing the hormone. Patients with~     Cushing disease have high levels of the hormone ACTH in the petrosal sinuses. Patients with~     other causes of Cushing syndrome do not have increased levels of ACTH in the petrosal~     sinuses.~      The procedure to collect blood from the petrosal sinus is called Inferior Petrosal Sinus~     Sampling (IPSS). The technique is very sensitive and can tell the difference between a~     pituitary tumor and other causes of Cushing syndrome nearly 100% of the time. However, IPSS~     is very difficult to perform and is only available in a few hospitals. Therefore, researchers~     are looking for another possible way to diagnose Cushing syndrome that would be less~     technically difficult and more readily available to patients.~      ACTH is produced in the pituitary gland as a response to the production of~     Corticotropin-Releasing Hormone (CRH) in the brain (hypothalamus). This study will compare~     ACTH levels in the internal jugular veins before and after CRH stimulation with those~     obtained by conventional IPSS from patients with Cushing's syndrome.~      Obtaining blood from the jugular veins is a simple, practically risk free procedure that~     could be done easily in a community hospital on an out patient basis. Researchers believe~     that CRH stimulation will increase ACTH production from tumors of the pituitary gland~     (corticotroph adenomas) so that the diagnostic information from jugular venous sampling would~     be equivalent to that of IPSS.~      This proposal to develop jugular venous sampling (JVS) with CRH stimulation as a test for the~     differential diagnosis of Cushing Syndrome would potentially contribute greatly to the~     medical care of patients with Cushing syndrome, as a less costly, safer and more widely~     available alternative to IPSS.<TAB>~   "
274649|NCT00001452|"~     Lentiginosis refers to groups of diseases marked by the presence of pigmented spots on the~     skin. These conditions are most commonly associated with multiple tumors and changes in~     hormone producing glands. The cause of these diseases is unknown, but researchers suggest~     there may be a level of inheritance involved in their development. Meaning to say that some~     of these diseases may run in the family and be passed down form generation to generation.~      Primary pigmented nodular adrenocortical disease (PPNAD) is a pituitary-independent, primary~     adrenal form of hypercortisolism characterized by;~        1. Resistance to suppression by the drug dexamethasone~        2. The body is unable to secrete cortisol in a normal rhythm~        3. Distinct microscopic changes of both adrenal glands~      PPNAD can be associated with tumors (myxomas) of the skin, heart, breast, tumors (swannomas)~     of the nerve sheaths, pigmented spots (nevi and lentigines) of the skin, growth hormone (GH)~     producing tumors of the pituitary gland, and tumors of the testicles, ovaries, and thyroid~     gland. In the presence of these associations the condition is referred to as the Carney~     Complex. Presently there are no tests for screening of PPNAD and the Carney Complex. In~     addition, it is unknown how these conditions are genetically transferred from generation to~     generation.~      This study proposes to use standard methods of clinical testing for endocrine and~     nonendocrine diseases and genetic testing in order to;~        1. Define the genetic basis for PPNAD and/or the Carney Complex.~        2. Determine the molecular changes associated with the development of the tumors.~        3. Identify carriers of the disease.~        4. Determine the prognosis for carriers and affected individuals.~        5. Provide sufficient data for genetic counseling of families with PPNAD and/or Carney~          Complex.<TAB>~   "
274650|NCT00001451|"~     Individuals interested in becoming prospective bone marrow donors and joining the Registry of~     the National Marrow Donor Program (NMDP) should do so by calling 301-496-0572, the phone~     number of the NIH Marrow Donor Center. An appointment will be made to have a health history~     taken and to have a buccal swab collected for tissue (HLA) typing. The current protocol only~     involves donors already registered with the NMDP, who have been identified as perfect~     matches for an unrelated patient requiring a bone marrow transplant, and who require~     expedited medical evaluation prior to marrow collection.~   "
274651|NCT00001444|"~     This is a dosage escalation study to estimate the maximum tolerated dose of staurosporine~     analogue UCN-01. Groups of 3 to 6 patients receive a 72-hours intravenous continuous~     infusions of UCN-01 from day 1 to day 4 of each cycle the first cycle only, and over 36-hours~     on subsequent cycles. The side effects are allowed to disappear for up to 28 days. This cycle~     is repeated after evaluations and follow-ups, which are every 4 weeks, as long as the patient~     benefits.~   "
274652|NCT00001442|"~     Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Irradiation of tumor and~     involved nodes using 4-6 MV photons (brachytherapy allowed to boost primary tumor; electrons~     allowed to boost posterior neck and massive adenopathy); plus Paclitaxel (Bristol-Myers),~     Taxol, TAX, NSC-125973.~   "
274653|NCT00001440|"~     The ability of chemotherapy to cure cancer, including breast cancer, has been limited by drug~     resistant residual tumor cells remaining after chemotherapy that generally result in relapse.~     Additional therapeutic strategies to eradicate these residual tumor cells are needed. The~     augmentation of specific anti-tumor immune responses, such as those mediated by T-cells,~     might represent such an additional strategy for the control or elimination of residual tumor~     cells. This approach might be especially effective if T-cell mediated responses were enhanced~     during both the period of T-cell repopulation that follows acute T-cell depletion and in the~     setting of minimal residual tumor burden present after dose intensive chemotherapy. Such~     chemotherapy is known to result in severe T-cell depletion. This pilot study has been~     designed to examine the feasibility of combining dose intensive chemotherapy with~     interventions aimed at the reconstitution of T-cell immunity. Metastatic or adjuvant breast~     cancer patients who have received dose intensive chemotherapy will subsequently receive a~     combination of autologous chemotherapy-naive T-cells, a patient-specific tumor antigen~     vaccine, and recombinant human interleukin-2. These interventions will be assessed for their~     ability to modulate T-cell number, T-cell function, and T-cell specificity during the period~     of T-cell repopulation. Such modulation may result in the effective reconstitution of~     generalized T-cell immunity with the generation of vaccine-specific anti-tumor T-cell~     responses.~   "
274654|NCT00001432|"~     Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with~     chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is~     available as a treatment option to only a minority of patients. Autologous BMT, coupled with~     high dose chemotherapy, is a treatment open to more patients and is a promising strategy for~     the treatment of advanced solid malignancies. However, the development of potentially~     curative marrow transplant alternatives requires an ability to provide a nonmalignant~     hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells~     (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage~     subtypes following reinfusion are critical to understanding the biology and immunological~     consequences of stem cell transplantation. An increased understanding of the kinetics of HSC~     and lymphocyte repopulation post-BMT and the identification of donor cell populations that~     mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to~     therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers~     and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or~     without prior [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, infusion to provide cell populations~     which will then be utilized for specific pre-clinical studies aimed at developing new~     therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies.~     An infusion of [6,6-(2)H(2)] or [U-(13)C(9)]-glucose prior to bone marrow and/or leukocyte~     harvest, in some volunteers, will allow direct examination of the genesis and biology of stem~     cells and leukocyte subpopulations. [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, are~     nonradioactive, stable isotopes of glucose which will label dividing cells during the time of~     administration and is chemically identical to glucose, with no adverse side effects other~     than those known for glucose.~   "
274656|NCT00001426|"~     A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human~     ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for~     8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration~     causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and~     continuous exposure is needed. This study will evaluate the combination of continuously~     administered CAI with three-weekly paclitaxel.~   "
274657|NCT00001420|"~     This study will examine the genetic and immune factors involved in the cause and development~     of psoriatic arthritis-a disease of both the skin and joints. It will describe the medical~     features and natural course of the disease and determine participants' eligibility for~     experimental treatment protocols.~      Patients with known or suspected psoriatic arthritis 5 years of age and older and their~     relatives may enroll in this study. Patients will be evaluated with a medical history and~     physical examination, electrocardiogram, blood tests and X-rays. Additional procedures may~     include:~        1. Leukapheresis-Collection of white blood cells for genetic analysis. Whole blood is~          collected through a needle placed in an arm vein. The blood circulates through a machine~          that separates it into its components. The plasma is removed and the cells are returned~          to the body through a second needle placed in the other arm.~        2. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is~          numbed with an anesthetic and one to three small circular portions (about 1/4 inch in~          diameter) are cut and removed.~        3. Joint aspiration-Removal of a small sample of synovial fluid (lubricating joint fluid).~          An area of skin around the biopsy site is numbed with an anesthetic, and a needle is~          inserted into the joint to pull out a small fluid sample.~        4. Synovial needle biopsy-Removal of a small sample of synovial tissue (tissue lining the~          joint). An area of skin around the biopsy site is numbed with an anesthetic and a large~          needle is inserted into the joint. A smaller needle attached to a syringe is then placed~          inside the larger needle and small pieces of synovial tissue are removed.~        5. Genetic studies-Saliva and blood samples will be collected for gene testing. Saliva is~          collected by rinsing the mouth with a tablespoon of salt water and spitting into a test~          tube.~      Patients will be followed once or twice a year and may be evaluated for participation in an~     experimental treatment study.~      Participating relatives of patients will fill out a brief medical history questionnaire and~     provide a DNA sample (blood sample or tissue swab from the inside of the cheek).~   "
274658|NCT00001418|"~     This study is designed to use PET scans in order to measure activity of the sympathetic~     nervous system. The sympathetic nervous system is the portion of the nervous system that~     maintains a normal supply of blood and fuel to organs during stressful situations.~      PET scan or Positron Emission Tomography is an advanced form of an X-ray. It is used to~     detect radioactive substances in the body. During this study researchers plan to inject small~     amounts of the radioactive drug fluorodopamine into patients. Fluorodopamine is very similar~     to the chemicals found in the sympathetic nervous system. It can attach to sympathetic nerve~     endings and allow researchers to view them with the aid of a PET scan. One area of the body~     with many sympathetic nerve endings is the heart. After giving a dose of fluorodopamine,~     researchers will be able to visualize all of the sympathetic nerve endings involved in the~     activity of the heart. In addition, this diagnostic test will help researchers detect~     abnormalities of the nervous system of patient's hearts.~   "
274659|NCT00001417|"~     Tumors of the spine can be described as primary, meaning that the tumor originated from cells~     normally found in the spine, or metastatic, cells from another area of the body that have~     spread to the spine. Metastatic tumors are more common than primary tumors. Tumors of the~     spine can press against the spinal cord and interfere with information traveling down from~     the brain to the nerves of the spinal cord. As a result, patients with spinal tumors can~     suffer from loss of movement and sensation within areas of the body below the tumor. In~     addition, tumors of the spine are typically painful conditions.~      Presently, the treatment of choice for spinal tumors is radiation therapy. However, many~     tumors of the spine become resistant to radiation therapy. In addition, because the spinal~     cord is often so close to the tumor it can be damaged by the radiation.~      Absolute (100%) ethanol is commonly known as alcohol. It is the same kind of alcohol found~     in alcoholic beverages. When pure alcohol is injected directly into a tumor it can destroy~     cells and blood vessels. Because of this feature, researchers would like to test the~     effectiveness of alcohol in treating patients with spinal tumors.~      Researchers believe that intratumoral ethanol injection is a treatment worth studying more~     closely because it is minimally invasive, has been proven to be an effective treatment for~     other types of metastatic tumors, can be used repeatedly, and does not interfere with other~     treatments such as surgery.~      In addition to testing the effectiveness of intratumoral ethanol injection, this study will~     attempt to determine the causes of pain associated with spinal tumors.~   "
274660|NCT00001414|"~     Previous research involving families, twins, and adoption all support the idea that there is~     a substantial heritable aspect to personality.~      The goal of this research study is to determine how genetics influence heritable personality~     traits. The work will focus on how genetics affect the chemical messengers which brain cells~     use to communicate with each other (neurotransmitters).~      The study involves collecting personality data and DNA samples from related individuals,~     primarily male siblings and female siblings, but also including parents. Genetic tests~     performed on these samples will continue to focus on variations in genes, which potentially~     effect brain neurotransmission.~      This research has the potential to advance knowledge of genetic influences on human behavior~     that may be relevant both to normal personality and to psychopathology.~   "
274661|NCT00001413|"~     The purpose of this study is to examine calcium absorption and bone mineral density in women~     with depression.~      Research indicates that pre-menopausal women with depression have significantly lower bone~     mineral density (BMD) than pre-menopausal women without depression. Although the mechanisms~     of BMD loss are unclear, researchers believe that individuals with depression have impaired~     calcium absorption. However, it is unknown whether the abnormal absorption is a result of~     depression or a side effect of the drugs used to treat it. This study will compare calcium~     absorption in women with depression and in healthy women without depression.~      Participants in this study will be given two non-radioactive calcium isotopes. One can be~     taken by mouth and the other must be injected. Participants will have the level of isotopes~     in their urine measured to estimate true fractional calcium absorption (TFCA). Participants~     may also have a dual X-ray absorptiometry (DEXA) scan to measure total body adiposity and~     lean body mass.~   "
274674|NCT00001397|"~     This study is designed to allow the evaluation, follow-up, and medical care of patients with~     blood disorders not currently participating in a research study being conducted by the~     Hematology Branch of the National Heart, Lung and Blood Institute (NHLBI) or not being~     screened for participation in a study.~      The purpose of this study is to allow investigation into the blood disorders of patients in~     order to teach, learn, and gather more information about diseases of the blood.~      In addition, this study allows researchers the opportunity to evaluate patients referred to~     the Hematology Branch of the NHLBI with rare or undiagnosed diseases of the blood. This may~     be potentially beneficial to the patient and at the same time contribute to the development~     of new research ideas.~   "
274876|NCT00000445|"~     This 12-week trial will compare individuals receiving naltrexone or placebo plus substance~     abuse counseling therapy versus those receiving only substance abuse counseling therapy in a~     rural, nonacademic setting. A followup period of 12 months is included. The effect on service~     utilization and the cost of the addition of naltrexone to treatment services for alcohol~     dependence also will be assessed. The study will expand existing research concerning the~     effectiveness of naltrexone in clinical trials versus a clinical setting.~   "
274662|NCT00001412|"~     There is evidence that suggests male sex hormones (androgens) play a significant role in~     brain (central nervous system) functioning. In studies conducted with animals, researchers~     have documented that male sex hormones (androgens) are associated with neurotransmitter~     (serotonin) function, sexual behavior, aggression, and other non-reproductive behavior.~     Similar findings have been seen in studies involving humans.~      Androgens are thought to be involved in some neurologic conditions. Tourette's syndrome which~     is seen more often in males than females has caused researchers to look more closely at the~     effects of androgens on the brain.~      This study is designed to examine the effects of testosterone on brain (CNS) activity by~     first stopping testosterone release and then replacing it.~      Researchers will evaluate mood, behavior, cognitive (mental) function, physiologic response~     to serotonergic agonists and regional cerebral blood flow (r-CBF).~      This study will attempt to answer the following questions;~      1. Is a person's mental functioning a result of being male or female (gender) or a result of~     the hormonal condition~      3. Does the decrease of blood flow (r-CBF) to specific areas of the brain (prefrontal cortex)~     in women whose ovaries are not releasing hormones (hypogonadal state) also occur in men~      4. Will the mental rotation task better identify hormone (gonadal steroid) differences in~     r-CBF~      5. Do hormones directly influence the responsiveness of the hypothalamic-pituitary-adrenal~     (HPA) axis~      6. Does the hormonal state of a patient directly affect levels of chemicals and steroids in~     the cerebrospinal fluid (CSF).~   "
274663|NCT00001410|"~     Gaucher disease is a lysosomal storage disease resulting from glucocerebroside accumulation~     in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in~     patients of all ages. The condition is marked by enlargement of the liver and spleen~     (hepatosplenomegaly), low blood and platelet counts, and bone abnormalities. The condition is~     passed from generation to generation on via autosomal recessive inheritance. There are~     actually three types of Gaucher disease.~      Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease~     does not affect the nervous system. The symptoms of type I can appear at any age.~      Type 2 Gaucher disease presents prenatally or in infancy and usually results in death for the~     patient. Type 2 is an acute neuronopathic form and can affect the brain stem. It is the most~     severe form of the disease.~      Type 3 Gaucher disease is also neuronopathic, however it is subacute in nature. This means~     the course of the illness lies somewhere between long-term (chronic) and short-term (acute).~      Currently there is not a cure for Gaucher disease. Treatment for the disease has~     traditionally been supportive. In some severely affected patients, bone-marrow transplants~     have corrected the enzyme deficiency, but it is considered a high-risk procedure and recovery~     can be very slow. Enzyme replacement therapy is another therapy option and has been approved~     by the Food and Drug Administration (FDA) for use in type 1 patients.~      PEG-glucocerbrosidase is a drug designed to clear out the accumulation of lipid~     (glucocerebroside) from the blood stream. The drug is actually an enzyme attached to large~     molecules called polyethylene glycol (PEG). The large molecules of PEG allow the enzyme to~     remain in the blood stream for long periods of time. By modifying glucocerebrosidase with~     PEG, it is believed that smaller doses will be required, meaning a reduction in cost for the~     patient and more convenient administration of the drug. The purpose of this study is to~     evaluate the effects and safety of enzyme replacement therapy using PEG- glucocerebrosidase~     for the treatment of Gaucher disease.~   "
274664|NCT00001409|"~     Certain patients enrolled in NIH protocol 94-I-0206 at the Clinical Center may be eligible to~     participate in one or more of the following new options:~        -  Donor/recipient extension phase - Both the recipient (HIV-infected twin) and donor~          (non-infected twin) will participate in this extension of the CD4-zeta gene therapy~          study. It will evaluate the safety and activity of infusing gene-modified CD4+ cells as~          well as the modified CD8+ cells.~        -  Corticosteroid administration - A corticosteroid, such as prednisone, hydrocortisone or~          prednisolone, will be added to the interleukin-2 (IL-2) regimen for preventing or~          treating side effects of IL-2 such as fever and other flu-like symptoms.~        -  Extended follow-up - A more intensive follow-up will be scheduled for patients with~          substantial numbers of lymphocytes that harbor the CD4-zeta gene. Every 3 months,~          participants will have blood tests and specialized tests of CD4 counts, HIV-1 viral load~          and numbers of circulating cells containing the CD4-zeta gene every 3 months> the~          frequency of follow-up visits may be reduced as time goes by.~        -  IL-2 continuation - Participants will continue to receive periodic treatment with IL-2~          to see how long the genetically modified cells persist in the bloodstream and to~          evaluate the long-term response to IL-2.~        -  Home treatment with interleukin-2 - Participants may receive future IL-2 treatment~          cycles at home. Home treatment involves less frequent data and safety monitoring and no~          medical evaluations at the Clinical Center except at the beginning of each cycle.~   "
274665|NCT00001408|"~     This study will examine the movement of T cells (a type of white blood cell) from the blood~     to the lungs in patients with asthma after exposure to an allergen, such as cat dander or~     pollen. Asthma is in large part due to inflammation of the bronchi (the breathing tubes of~     the lungs), causing heat, swelling and redness. T cells play a major role in the inflammatory~     reaction. A better understanding of T cell migration to the lungs after allergen exposure may~     lead to improved therapies for asthma.~      Patients between 18 and 50 years of age with mild allergic asthma may be eligible for this~     study. In addition, patients and healthy normal volunteers between 18 and 65 years of age may~     participate in a sub-study (blood draw) of this protocol. Participants will undergo the~     following procedures:~      Visit 1 (screening visit)~        -  Blood tests for blood counts and HIV~        -  Urine pregnancy test for women of childbearing potential.~      Visit 2~        -  Physical examination and electrocardiogram (EKG)~        -  Prick skin testing - A drop of allergen extract is put on the skin and the underlying~          skin is scratched with a needle. A positive test resembles an insect bite and may itch.~        -  Intradermal skin tests - Increasing concentrations of a drop of diluted allergen are~          injected into the skin and the allergic response is monitored until a 5-mm swelling (1/4~          inch) swelling develops.~        -  Methacholine challenge - The subject has repeated pulmonary function (breathing) tests~          after breathing methacholine, a drug that temporarily (for 5 to 10 minutes) worsens~          asthma symptoms.~        -  Physician evaluation and repeat pulmonary function test~      Visit 3~      - Allergen bronchoprovocation - This test will be done in patients whose physical evaluation~     and breathing test permit them to continue with the study. A heparin lock (needle device that~     stays in a vein to allow multiple blood draws without repeated sticks) is placed. The subject~     breathes 5 breaths of allergen through a nebulizer (device that creates a mist), followed by~     a breathing test. This procedure will be repeated with increasingly higher allergen doses~     until lung function significantly declines or for a maximum of 6 doses. Subjects are~     monitored for 8 hours after the last dose. Blood samples of 50 ml each (3.5 tablespoons) are~     collected at 1, 3, 5 and 8 hours, and a physician evaluation is done at the end of the 8~     hours. Additional 50-mm blood samples are collected the following two mornings.~      Visit 4~        -  Physician evaluation, blood test for anemia and pulmonary function test~        -  Serial blood draws - 50 ml of blood will be drawn, followed by salt-water nebulization~          and another 50-ml blood draw after 1 hour. Additional 50-ml blood samples will be drawn~          7 hours later and then on the next two mornings.~      Participants in the sub-study portion of this protocol will undergo the screening blood test,~     prick skin testing, breathing test after methacholine inhalation and a 100 ml-blood draw.~     These tests will be done in three sessions.~   "
274680|NCT00001390|"~     Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated~     several disorders of salivary glands. The purpose of this protocol is to obtain data from~     healthy volunteers for comparison with data from patients with salivary dysfunction. We plan~     to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid~     participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits~     that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry~     eye examination, and lip biopsy follow up, as needed. These are routine diagnostic~     procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro~     biochemical analysis or in vivo transplantation.~      Some of the Healthy Volunteers may be asked to participate in an MRI study of the salivary~     glands.~   "
274666|NCT00001407|"~     This study will determine what dose of recombinant interferon-gamma is safe and effective for~     treating multiple drug-resistant tuberculosis. Recombinant interferon-gamma is a genetically~     engineered form of a substance normally produced by the body and is used to boost immune~     function.~      Patients 5 years of age and older with multiply drug-resistant tuberculosis may be eligible~     for this study.~      Participants will be admitted to either the NIH Clinical Center in Bethesda, Maryland, the~     Texas Center for Infectious Diseases in San Antonio or the South Texas Hospital or Valley~     Baptist Hospital, both in Harlingen, Texas. On admission, patients will have a medical~     history, physical examination, blood and urine tests, sputum culture, X-rays, pulmonary~     function tests and a computed tomography (CT) scan. CT produces 3-dimensional images of body~     tissues and organs in small sections. For the procedure, the patient lies still on a table~     surrounded by the scanner.~      All patients will continue treatment with anti-tuberculosis antibiotics during and after the~     study period and may elect whether or not to take gamma interferon in addition to the~     antibiotic. Five patients will receive only antibiotic treatment, and 5 each will receive one~     of 3 doses (0.025, 0.05 or 0.1 milligrams per square meter of body surface area) of~     interferon-gamma injected under the skin 3 times a week. The patient or caregiver will be~     taught to give the injections, which are similar to insulin injections for diabetes.~      Patients will be in isolation in the hospital from the start of therapy until sputum samples~     show no evidence of tuberculosis for 3 consecutive weeks. Following that, they will repeat~     the tests done on admission (except CT) during follow-up visits (1- to 2-day~     hospitalizations) at 3, 6, 9, 12, 15, 18 and 24 months after the start of therapy. Patients~     taking interferon gamma will have blood drawn more frequently (monthly) for the first 6~     months, and patients with lung infection will have sputum samples collected more~     frequently-weekly for the first 3 months or until three consecutive negative samples are~     obtained and then monthly throughout the course of therapy. Patients with lung infection will~     also have repeat CT scans at 6 and 12 months while on interferon gamma. In one or two~     patients on the drug, blood will be drawn frequently following one injection of gamma~     interferon (just before the injection and again at 0.25, 0.5, 1, 6, 12, 18, 24 and 48 hours~     after it) to see if a difference in blood levels of the drug can be detected.~   "
274667|NCT00001406|"~     This study will investigate how, why and under what conditions eosinophils (a type of white~     blood cell) become activated and will examine their function in immune reactions. Eosinophil~     counts often rise in response to allergies, asthma, and parasitic worm infections. They can~     also go up in uncommon autoimmune conditions and, rarely, in association with tumors.~     Elevated levels of these cells is called eosinophilia. Usually, eosinophilia causes no~     apparent symptoms, but in rare cases there may be local swelling and itching, allergic lung~     problems, heart disease or nerve damage caused by the release of toxic substances in these~     cells into body tissues.~      Patients 1 to 100 years of age with eosinophil counts greater than 750/ml or an abnormal~     accumulation of eosinophils in the skin or body tissues may be eligible for this study. All~     participants will have a thorough medical history, physical examination and blood tests.~     Depending on the person's age and symptoms, other diagnostic tests may be done, including~     specialized studies of the eye, lungs, skin, bone marrow, nerves or heart. This is not a~     treatment study, and no experimental treatments will be offered. Patients who require~     treatment will receive standard medical care.~      Certain other procedures may be requested solely for research purposes. All participants will~     be asked to donate extra blood for laboratory studies investigating how immune cells and~     other immune substances in the blood act to stimulate a rise in eosinophils. In addition,~     some participants may undergo one or more of the following:~        -  <TAB>Annual Follow-up evaluations - Physical examinations and blood tests to evaluate~          changes in the patient's condition and eosinophil counts over time.~        -  <TAB>Bone marrow biopsy and aspiration will be recommended during the initial~          evaluation, and in certain patients at other times when it is important to look directly~          at the newly developing cells in the bone marrow. For this procedure an area of skin and~          bone is anesthetized with xylocaine (an anesthetic similar to that used by dentists),~          and a very sharp needle is used to sample the bone marrow for evaluation. Bone marrow~          biopsy and aspiration can have side effects of pain and/or bleeding into the skin and~          soft tissues at the site of the procedure. Rarely the area at the biopsy site can become~          infected, and is treated with antibiotics.~        -  <TAB>Genetic testing: Some of the blood drawn from you as part of this study will be~          used for genetic tests. Genetic tests can help researchers study how health or illness~          is passed on to you by your parents or from you to your children. Any genetic~          information collected or discovered about you or your family will be confidential.~        -  <TAB>Leukapheresis (only patients 18 years and older) to collect large numbers of~          certain cells - In this procedure, whole blood is collected through a needle placed in~          an arm vein. The blood circulates through a machine that separates it into its~          components. The white cells are then removed and the rest of the blood is returned to~          the body, either through the same needle used to draw the blood or through a second~          needle placed in the other arm.~   "
274668|NCT00001405|"~     This protocol is designed to study the techniques needed to develop gene therapy or other~     treatments for certain inherited immune system diseases.~      Healthy normal volunteers between 18 and 65 years of age and patients with chronic~     granulomatous disease (CGD), X-linked severe combined immune deficiency (X-SCID), leukocyte~     adhesion deficiency (LAD), interferon gamma receptor deficiency (IGR-deficiency) or other~     inherited diseases affecting precursor blood cells-bone marrow cells that generate blood~     cells-may be eligible for this study. Patients who have had repeated severe infections~     possibly due to an inherited blood cell abnormality may also participate. Candidates will be~     screened with a medical history, physical examination and blood tests.~      Patients with an active infection will be hospitalized during this study. Uninfected~     participants will be seen as outpatients at the NIH Clinical Center. Participants will have~     the following procedures:~        -  G-CSF administration All participants will have daily injections of granulocyte-colony~          stimulating factor (G-CSF). This drug is a genetically engineered hormone that~          stimulates the bone marrow to release white blood cells and white cell precursors into~          the bloodstream. The injections are given under the skin in the arm or leg, using a very~          small needle. Patients will have injections for 6 or 7 days, normal volunteers for 5. A~          small blood sample will be drawn each day of the injections to monitor white cell counts~          and changes in the number of blood cell precursors. (Smaller children and all children~          under 10 years of age may have blood drawn on alternate days or less to reduce the~          number of needle sticks and the amount of blood taken.). Larger blood draws will be~          taken on days 6 and/or 7 for patients and on days 5 and/or 6 for normal volunteers.~        -  Leukapheresis This procedure for collecting larger numbers of circulating blood~          precursor cells is optional and may take the place of the larger blood draw described~          above. Patients 5 years old or older may have leukapheresis. Whole blood is collected~          through a needle in an arm vein. The blood circulates through a machine that separates~          it into its components. The desired cells are then removed and the rest of the blood is~          returned to the body, either through the same needle or through a second one placed in~          the other arm. The cells obtained will be used to purify blood precursors for growing in~          culture and to examine the ability to transfer new genes into these precursor cells. For~          patients whose arm veins are too scarred to for needle placement, a vein in the groin~          area (femoral vein) may be used instead.~        -  Bone marrow aspiration - This procedure for obtaining a bone marrow sample is optional.~          Normal volunteers who agree to the procedure may undergo aspiration up to three times.~          The hip area is anesthetized and a small sample of bone marrow is drawn through a~          special needle inserted in the hipbone. The first aspiration is done on a day before the~          G-CSF injections are started; the second is done soon after the last injection (day 6 or~          7), and the third is done from 7 to 10 days after the last injection.~        -  Repeat blood tests - At day 6 or 7 some of the blood tests done at the beginning of the~          study will be repeated to check blood counts and liver and kidney function.~      Four months or more after the end of the study, participants will be asked to repeat the~     entire procedure to examine the effects of two cycles of G-CSF mobilization in the same~     individual. This second cycle is optional.~   "
274669|NCT00001404|"~     We aim to delineate the range of severity, natural history, molecular etiology, and~     pathophysiology of Pallister-Hall syndrome (PHS), Greig cephalopolysyndactyly syndrome~     (GCPS), McKusick-Kaufman syndrome (MKS), Bardet-Biedl syndrome (BBS), Oro-facial digital~     syndromes (OFDs), and other overlapping phenotypes. These disorders comprise a syndrome~     community of overlapping manifestations and we hypothesize that this is a reflection of a~     common mechanistic pathway. This hypothesis be addressed by a combined clinical-molecular~     approach where we bring up to 50-100 patients with each disorder to the NIH clinical center~     for a comprehensive clinical evaluation with follow-up at a frequency appropriate to the~     disorder. Specimens will be collected and evaluated in the laboratory by linkage analysis,~     physical mapping, candidate gene characterization, mutation screening, and cell biologic~     studies of normal mutant proteins.~   "
274670|NCT00001403|"~     This study will examine rare congenital disorders that involve malformations and abnormal~     growth. It will focus on patients with Proteus syndrome, whose physical features are~     characterized by overgrowth, benign tumors of fatty tissue or blood vessels, asymmetric arms~     or legs, and large feet with very thick soles. The study will explore the genetic and~     biochemical cause and course of the disease, the changes in symptoms over time, and the~     effects of the disease on patients.~      Patients with Proteus syndrome and their parents may be eligible for this study. Parents will~     be studied, when possible, for comparison of molecular findings. Study candidates will have a~     medical history and physical examination, including X-rays and possibly other imaging tests,~     such as computerized tomography (CT), magnetic resonance imaging (MRI) and ultrasound. Other~     tests and examinations may be done if needed.~      Those enrolled in the study will have will be interviewed or complete questionnaires, or~     both, about how their disease affects them. (Parents will be asked about their feelings about~     having a child with a rare disorder.) Patients will provide a small blood sample for research~     and may be asked to undergo biopsies from a normal area of skin and from a tumor.~   "
274671|NCT00001400|"~     This study is designed to screen patients with heart diseases who may qualify to participate~     in other research studies being conducted by the Cardiology Branch of the National Heart,~     Lung, and Blood Institute (NHLBI).~      Patients participating in this research study will be seen on an outpatient basis and undergo~     a general medical evaluation, including blood tests, urine, examination, chest x-ray and~     electrocardiogram (EKG). In addition, patients may be asked to have an echocardiogram~     (ultrasound scan of the heart) and to perform an exercise stress test.~      Patients participating in this study will not receive any investigational treatments.~   "
274672|NCT00001399|"~     Fanconi's Anemia is an inherited disorder that can produce bone marrow failure. In addition,~     some patients with Fanconi's anemia have physical defects usually involving the skeleton and~     kidneys. The major problem for most patients is aplastic anemia, the blood counts for red~     blood cells, white blood cells, and platelets are low because the bone marrow fails to~     produce these cells. Some patients with Fanconi's anemia can develop leukemia or cancers of~     other organs.~      Many laboratory studies have suggested that Fanconi's anemia is caused by an inherited defect~     in the ability of cells to repair DNA. Recently, the gene for one of the four types of~     Fanconi's anemia, type C, has been identified. It is known that this gene is defective in~     patients with Fanconi's anemia type C.~      Researchers have conducted laboratory studies that suggest Fanconi's anemia type C may be~     treatable with gene therapy. Gene therapy works by placing a normal gene into the cells of~     patients with abnormal genes responsible for Fanconi's anemia type C. After the normal gene~     is in place, new normal cells can develop and grow. Drugs can be given to these patients kill~     the remaining abnormal cells. The new cells containing normal genes and will not be harmed by~     these drugs.~      The purpose of this study is to test whether researchers can safely place the normal~     Fanconi's anemia type C gene into cells of patients with the disease. The gene will be placed~     into special cells in the bone marrow called stem cells. These stem cells are responsible for~     producing new red blood cells, white blood cells, and platelets.~   "
274673|NCT00001398|"~     This trial, sponsored by Amgen, Inc., which produces the recombinant methionyl human stem~     cell factor (r-metHuSCF), also involves two other institutions. The primary objective is~     determination of the safety of administering multiple doses of r-metHuSCF in the setting of~     acquired aplastic anemia and evaluation of the effect of r-metHuSCF on peripheral blood~     counts. Potential effects of r-metHuSCF on frequency of need for red cell or platelet~     transfusions and on bone marrow morphology/cellularity will also be evaluated.~   "
274877|NCT00000444|"~     This study will attempt to determine the best time to begin a smoking cessation program in~     individuals who undergo intensive treatment for alcohol dependence. The goal of this trial is~     to determine whether a smoking cessation program is more effective if it occurs at the same~     time as or after treatment for alcohol dependence. The study also will attempt to determine~     the effect of smoking cessation programs on the outcome of treatment for alcohol dependence.~   "
274675|NCT00001396|"~     Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the~     symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies~     have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of~     HCM in children. However, growth of the body and organs, including the heart, is very rapid~     during childhood. Therefore the long-term effects of DDD pacing in children are unknown.~      The purpose of this study is to examine the growth rate and nutrition of children with HCM.~     Due to this heart condition and the restrictions that are often placed on the child's~     activity level, children with HCM may grow at a slower rat and may have a greater tendency to~     be overweight.~      Children participating in the study will have their growth rate and nutritional status~     measured before the study begins and throughout the course of the study.~      Findings in this research study will not directly benefit the patients participating in it.~     However, information gathered as a result of this study may lead to improvements in the~     management of children with HCM in the future.~   "
274676|NCT00001394|"~     Occasionally tumors of the parathyroid gland cannot be detected by standard x-ray diagnostic~     procedures (CT scans, MRIs, and ultrasounds). In order for the tumor to be removed surgically~     it must first be localized. To do this often requires a procedure known as parathyroid~     arteriography and parathyroid venous sampling.~      This procedure begins by placing a catheter through a blood vessel in the groin. The catheter~     is then guided through blood vessels to reach the area of the neck. The blood vessels in this~     region flow in and out of the thyroid and parathyroid. An X-ray dye is then injected through~     the catheter into the arteries of the thyroid/parathyroid (parathyroid arteriography). The~     alternative is taking a small sample of the veins found in this same region (parathyroid~     venous sampling).~      Researchers prefer parathyroid arteriography because it causes less discomfort to the patient~     and requires less experience to do the procedure. However, parathyroid arteriography provides~     positive results in only 50% of patients undergoing the procedure. Parathyroid venous~     sampling provides greater amounts of positive results but the readings are often imprecise.~     Parathyroid tissue secretes a hormone known as PTH (parathyroid hormone). The release of PTH~     is stimulated by low levels of calcium in the blood.~      The idea behind the study is to inject a dye into the area of the parathyroid that will cause~     a release of PTH. Several parathyroid venous samplings will be taken following the abrupt~     elevation of PTH. This will provide information on the effectiveness of an intraarterial~     hypocalcemic stimulus (injection of dye into the arteries of the parathyroid when calcium~     blood levels are low) and venous sampling as techniques to improve localizing parathyroid~     tumors.~   "
274677|NCT00001393|"~     Glomerulonephritis is a disease which affect the kidneys. Occasionally these diseases can~     progress to a loss of kidney function in some patients. Glomerulosclerosis or focal segmental~     glomerulosclerosis (FSGS) is one form of glomerulonephritis.~      The cause of FSGS is unknown and often occurs on its own (idiopathic), or it can be~     associated with HIV (Human Immunodeficiency Virus). FSGS occurs more commonly among black~     patients than Caucasian or Hispanic patients. Researchers believe that environmental factors~     may interact with genetic mutations to cause FSGS, at least in some patients.~      This study will attempt to identify genetic factors associated with the development of FSGS.~     The study population will be made up of 600 total subjects divided into 3 groups. Group one~     will be 200 African-Americans with FSGS. Group two will be 200 African-Americans with HIV but~     without FSGS. Group three will be 200 non-African-Americans with FSGS.~      Study participation requires that researchers obtain 20 ml (2 tubes of blood). The genetic~     material (DNA) will be prepared from the white blood cells and analyzed. The results of each~     group will be compared with the results from the other groups to determine if one or more~     genes predisposes to FSGS. In the long run, studies that demonstrate a genetic basis for FSGS~     may help us identify patients earlier and may lead to improved therapies....~   "
274678|NCT00001392|"~     The present protocol seeks to advance our understanding of sclerosing glomerular and~     tubulointerstitial kidney diseases, including but not limited to variants of focal segmental~     glomerulosclerosis (FSGS) and chronic kidney disease of unknown etiology (CKDu). This~     protocol will encompass studies of the natural history, pathogenesis and treatment of these~     chronic kidney disorders. It will also allow us to: (1) provide second opinions to referring~     physicians about management of subjects with these relatively rare kidney diseases; (2)~     collect research samples (e.g., blood), urine, and kidney tissue obtained from~     clinically-indicated or from research renal biopsies); (3) and treat these subjects with~     standard or other approved therapies; or (4) invite selected subjects patients to participate~     in limited pilot studies of novel combinations of standard therapeutic agents, such as~     rituximab and cyclosporine. (5) Agricultural worker chronic kidney disease of undetermined~     etiology (CKDu) is a growing problem in tropical countries in the Americas and Asia,~     including Sri Lanka where collaborators are located. We will receive kidney tissue from 25~     CKDu cases for pathologic examination and transcriptional profiling and blood, plasma, serum,~     urine for metabolomic and genetic analysis from 50 cases and controls. Subjects were~     consented and samples were collected under a protocol approved by the University of Colombo~     IRB. These studies may provide the opportunity to generate new hypotheses regarding~     pathogenesis and treatment that would be candidates for testing in other research protocols.~      Subjects with known or suspected forms of sclerosing glomerular or chronic, fibrosing~     tubulointerstitial kidney diseases will undergo routine medical evaluation, laboratory~     testing, imaging procedures and kidney biopsies as medically indicated. Selected subjects~     will be invited to provide informed consent to undergo a kidney biopsy for research purposes.~     Blood, urine, and tissue samples will be evaluated both for standard diagnostic purposes and~     for research purposes using specialized molecular methods that may provide insights into~     specific disease pathogenesis. Subjects may elect to receive the results of their kidney~     disease evaluation, NIH treatment recommendations, and return to the care of their referring~     physicians. Other subjects may be treated with either conventional or approved agents, or~     (with separate consent) with a novel combination of conventional therapies (rituximab and~     cyclosporine) as part of pilot studies that would involve long-term follow-up care at the~     NIH.~   "
274679|NCT00001391|"~     Deficient or inappropriate healing of bone impacts clinical decision-making and treatment~     options in orthopedics, oral and maxillofacial surgery, plastic surgery and periodontics.~     While a number of auto- and allografting techniques have been used to regenerate craniofacial~     defects caused by infective, neoplastic or trauma-induced bone loss, each method has~     significant limitations. Our research group in the Craniofacial and Skeletal Diseases Branch~     of NIDCR has developed methods to culture and expand cell populations derived from mouse bone~     marrow stroma. We believe that an important next step is to apply the information gained in~     animal studies to treat osseous defects in humans. We propose to examine the potential of~     cultured human bone marrow stromal cells to serve as an abundant source of osteoblastic~     progenitor cells. These cells will ultimately be used to graft craniofacial osseous defects.~     In the course of this study we will: (1) develop methods for the propagation and enrichment~     of osteoblastic progenitor cells from bone marrow stroma; (2) test various vehicles for the~     transfer of bone marrow stromal cells to osseous defects in recipient animals; (3) determine~     optimal culturing and transplantation conditions for the eventual transplantation of bone~     marrow stromal cells into human recipients. These studies will define the parameters of bone~     marrow stromal cell transplantation and will generate models for future therapeutic~     strategies.~   "
274681|NCT00001386|"~     Synthetic HIV Peptide Vaccines (Treatment Protocol)~      We are conducting a study to evaluate the safety of two peptide vaccines (given alone or in~     combination) in patients with early HIV infection. Patients entered onto the study must have~     >500 CD4 cells/mm(3) and have preserved cardiac, hepatic, renal, and bone marrow function.~     Patients must be off all anti-retroviral therapy for at least 6 months and may not have~     received any experimental HIV vaccines. The vaccines being testing in this trial are~     comprised of short peptide segments of the HIV envelope, including the V3 loop. In animal~     studies, the peptides were able to induce neutralizing antibodies as well as cytotoxic T~     responses to HIV. This will be the first trial in which they are given to humans. The study~     will last for approximately one year, during which time the volunteers will receive 6 peptide~     vaccines under the skin. For more information, please call Tino Merced-Galindez, R.N. at~     (301) 496-8959 or Dr. Richard Little at (800) 772-5464.~   "
274682|NCT00001379|"~     This study will evaluate the response and long-term effects of alpha-interferon in patients~     with lymphomatoid granulomatosis (LYG). The disease causes proliferation of destructive cells~     involving the lungs, skin, kidneys, and central nervous system.~      Patients ages 12 and older who have LYG and who are not pregnant or breast feeding may be~     eligible for this study. Alpha interferon or chemotherapy, or both, will be used. Alpha~     interferon is a protein the body naturally produces. If patients have grade 3 disease, they~     will usually receive EPOCH-rituximab (EPOCH-R) chemotherapy (each letter representing a~     drug). If patients have grade 1 or 2 disease, the will usually receive alpha interferon. If~     patients have LYG after receiving alpha interferon and/or EPOCH-R, they may receive rituximab~     alone or with alpha interferon. Rituximab is an antibody, binding to a specific molecule~     (CD20) present on most B-cell lymphomas. Doses of several drugs in EPOCH-R may be increased~     if patients tolerated them in the previous cycle. If patients respond to EPOCH-R but still~     have low grade LYG, they may receive alpha interferon. Researchers will also try to obtain a~     biopsy of patients lesions, to help in understanding the disease.~      Patients self-administer alpha interferon by injection under the skin three times weekly.~     They will visit the clinic every 2 to 12 weeks for follow-up. Patients will receive alpha~     interferon for 1 year after LYG goes away, depending on response. EPOCH-R has these drugs:~     rituximab by vein on Day 1; prednisone by mouth on Days 1 to 5; etoposide, doxorubicin, and~     vincristine as a continuous intravenous infusion on Days 1 to 5; and cyclophosphamide by~     intravenous injection over 1 hour on Day 5. Each cycle lasts 3 weeks: 5 days of chemotherapy~     and 16 days of no chemotherapy. Etoposide, doxorubicin, and vincristine are infused through a~     small pump worn by patients. The drugs are given over 5 days through a central intravenous~     catheter. There are two cycles of EPOCH-R beyond a maximum response, with six cycles minimum.~     To reduce harm to bone marrow, patients receive granulocyte colony stimulating factor~     (G-CSF), self-administered by injection under the skin daily for approximately 10 days~     between chemotherapy cycles. If at the end of therapy, patients have a complete response,~     treatment will stop. If there is residual low grade disease, patients may receive alpha~     interferon. Alpha interferon can have flu-like side effects of headache, fever, chills, and~     body aches. EPOCH-R drugs can cause gastrointestinal problems, hair loss, and weakness. G-CSF~     can cause bone pain, body aches, and hair thinning. Chemotherapy can cause some patients to~     develop leukemia.~      This study may or may not have a direct benefit for participants. It is not certain whether~     the new therapy will help decrease tumors. However, knowledge gained may improve the~     understanding of and treatment for LYG.~   "
274683|NCT00001373|"~     This study is designed to explore the genetics and pathophysiology of diseases presenting~     with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome,~     and related diseases.~      The following individuals may be eligible for this study: 1) patients with known or suspected~     familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of~     these patients; 3) healthy, normal volunteers 7 years of age or older.~      Patients will undergo a medical and family history, physical examination, blood and urine~     tests. Additional tests and procedures may include the following:~        1. X-rays~        2. Consultations with specialists~        3. DNA sample collection (blood or saliva sample) for genetic studies. These might include~          studies of specific genes, or more complete sequencing of the genome.~        4. Additional blood samples a maximum of 1 pint (450 ml) during a 6-week period for studies~          of white cell adhesion (stickiness)~        5. Leukapheresis for collecting larger amounts of white cells for study. For this~          procedure, whole blood is collected through a needle in an arm vein. The blood flows~          through a machine that separates it into its components. The white cells are removed and~          the rest of the blood is returned to the body through another needle in the other arm.~      Patients may be followed approximately every 6 months to monitor symptoms, adjust medicine~     dosages, and undergo routine blood and urine tests. They will receive genetic counseling by~     the study team on the risk of having affected children and be advised of treatment options.~      Participating relatives will undergo a medical and family history, possibly with a review of~     medical records, physical examination, blood and urine tests. Additional procedures may~     include a 24-hour urine collection, X-rays, and consultations with medical specialists. A DNA~     sample (blood or saliva) will also be collected for genetic studies. Additional blood samples~     of no more than 550 mL during an 8-week period may be requested for studies of white cell~     adhesion (stickiness).~      Relatives who have familial Mediterranean fever, TRAPS, or hyper-IgD syndrome will receive~     the same follow-up and counseling as described for patients above.~      Normal volunteers and patients with gout will have a brief health interview and check of~     vital signs (blood pressure and pulse) and will provide a blood sample (up to 90 ml, or 6~     tablespoons). Additional blood samples of no more than 1 pint over a 6-week period may be~     requested in the future.~   "
274684|NCT00001372|"~     This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their~     relatives to learn more about how the disease develops and changes over time. It will also~     study genetic factors that make a person susceptible to SLE.~      Patients 10 years of age and older with known or suspected SLE and their relatives may be~     eligible for this study. Patients will be evaluated with a medical history and physical~     examination, blood and urine tests. Other procedures may include:~        1. Electrocardiogram~        2. 24-hour urine collection~        3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans,~          bone scans, and bone densitometry.~        4. Questionnaire about the degree of disease activity, and survey of risk factors for~          disease complications.~        5. Apheresis Collection of plasma (fluid portion of blood) or blood cells for analysis.~          Whole blood is collected through a needle in an arm vein. The blood circulates through a~          machine that separates it into its components. The required component (plasma or cells)~          is removed and the rest of the blood is returned to the body through the same needle or~          through a second needle in the other arm.~        6. Skin biopsy Removal of a small skin sample for microscopic analysis. An area of skin is~          numbed with an anesthetic and a small circular portion (about 1/4 inch in diameter) is~          removed, using a sharp cookie cutter-type instrument.~        7. Kidney, bone marrow or other organ biopsy Removal of a small sample of organ tissue.~          These biopsies are done only if they can provide information useful in better~          understanding the disease or making treatment decisions.~        8. Genetic studies Collection of a blood sample for gene testing.~      Patients will be followed at least once a year with a brief history and physical examination~     and routine blood and urine tests. Some patients may be seen more often. Treatment~     recommendations will be offered to patients' physicians, and patients who are eligible for~     other research treatment studies will be invited to enroll.~      Participating relatives of patients will fill out a brief medical history questionnaire and~     provide a DNA sample (either a blood sample or tissue swab from the inside of the cheek) for~     genetic testing.~   "
274685|NCT00001368|"~     Early studies have shown that the immune system may play a role in the development of~     strokes. Conditions such as high blood pressure, high cholesterol, diabetes, and old age can~     activate the immune system and increase the risk of developing hardening of the arteries~     (atherosclerosis) and damaged blood vessels.~      Researchers will attempt to characterize factors that may contribute to atherosclerosis and~     stroke by measuring certain components of the immune system, cytokines and leukocyte~     activation. Measurements will be taken from patients that are considered to be stroke prone~     and from patients without risk factors for the development of stroke. Researchers will~     measure the immune system components at the beginning of the study, at six months, and at the~     one-year completion of the study.~      The study will attempt to determine;~      I) If patients with risk factors for stroke have an increased activation of the immune system~      II) If patients with risk factors for stroke that are symptomatic have higher levels of~     immune system activation compared to patients who do not have symptoms~      III) If patients with increased activation of the immune system have accelerated hardening of~     the arteries (atherosclerosis)~   "
274686|NCT00001367|"~     The goal of this study is to diagnose and follow patients with disorders of movement control.~     Patients participating in this study will undergo routine laboratory tests and examinations~     in order to monitor their condition.~      Doctors at the NIH will work in cooperation with each patient's primary care physician. There~     will be no use of investigational treatments in this study.<TAB>~   "
274688|NCT00001364|"~     Arteriovenous malformations (AVM) are abnormally formed blood vessels that can be located~     throughout the brain and spinal cord. Patients with abnormalities of the blood vessels~     located in and around the spinal cord can develop many neurological problems. Some problems~     include, weakness, pain, difficulty walking, paralysis, and even death.~      The treatment for these AVMs depends on their location, the type of malformation, the area of~     the spine involved, and the condition of the patient at the time of treatment. The treatment~     is aimed at stopping the neurologic problems from worsening and possibly correcting the~     existing problems. There are two commonly used treatments for AVMs, surgery and embolization~     (blocking off of blood flow to the AVM).~      However, researchers have limited experience treating these conditions because they are rare.~     In addition, it has been difficult to classify different kinds of AVMs and to develop new~     treatments for them.~      This study is designed to increase researchers understanding of AVMs by admitting and~     following patients diagnosed with the condition. By increasing the amount of patients studied~     diagnosed with spinal blood vessel abnormalities, researchers can begin to develop new~     management plans for patients with AVMs.~   "
274689|NCT00001362|"~     This study is divided into two parts. The first part of the study will use MRI technology to~     view the brain structure of patients with neurological disorders and normal volunteers. This~     portion of the study will attempt to detect specific areas of damage in the brains of~     patients with amnesia and dementia. It will also try to correlate the amount of brain damage~     with performance on tests used to measure memory.~      In the second part of the study, researchers plan to use MRI technology to study brain~     function of patients with neurological disorders and normal volunteers when they perform~     tasks. MRI signals during task performance will be used to record areas of the brain~     receiving more blood flow indicating increased activity.~      Researchers believe this study will help improve existing methods of evaluating patients with~     neurological disorders. In addition, this study may contribute information about areas of the~     brain involved in thought processing and motor and sensory function.~   "
274690|NCT00001361|"~     Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the~     human body without the use of X-ray (radiation). MRI is especially useful when studying the~     brain, because it can provide information about certain brain functions. In addition, MRI is~     much better than standard X-rays at showing areas of the brain close to the skull and~     detecting changes in the brain associated with neurological diseases. In this study~     researchers will use MRI to gather information about the processes that control human~     movement and sensory processing.~      The purpose of the study is to investigate how the brain is activated when remembering,~     thinking, or recognizing objects. Researchers would like to determine what happens to brain~     functions when patients have trouble remembering, thinking, or recognizing objects following~     the start of disorders in the brain and nervous system. In addition, this study will~     investigate the processes of motor control in healthy volunteers and patients with disease.~   "
274691|NCT00001360|"~     The purpose of this study is to use brain imaging technology to measure changes in blood flow~     to areas in the brain as individuals perform intellectual tasks.~      This study will use functional magnetic resonance imaging (fMRI) to examine blood flow to~     areas of the brain as participants engage in tasks associated with visual perception, visual~     recognition, and memory.~   "
274692|NCT00001359|"~     A subgroup of patients with childhood-onset obsessive-compulsive disorder (OCD) and/or tic~     disorders has been identified who share a common clinical course characterized by dramatic~     onset and symptom exacerbations following group A beta-hemolytic streptococcal (GABHS)~     infections. This subgroup is designated by the acronym PANDAS (Pediatric Autoimmune~     Neuropsychiatric Disorders Associated with Streptococcal infections). There are five clinical~     characteristics that define the PANDAS subgroup: presence of OCD and/or tic disorder;~     prepubertal symptom onset; sudden onset or abrupt exacerbations (relapsing-remitting course);~     association with neurological abnormalities (presence of adventitious movements or motoric~     hyperactivity during exacerbations); and temporal association between symptom exacerbations~     and GABHS infections. In this subgroup, periodic exacerbations appear to be triggered by~     GABHS infections in a manner similar to that of Sydenham's chorea, the neurological variant~     of rheumatic fever.~      Rheumatic fever is a disorder with a presumed post-streptococcal autoimmune etiology. The~     streptococcal pathogenesis of rheumatic fever is supported by studies that have demonstrated~     the effectiveness of penicillin prophylaxis in preventing recurrences of this illness. A~     trial of penicillin prophylaxis in the PANDAS subgroup demonstrated that penicillin was not~     superior to placebo as prophylaxis against GABHS infections in these children, but this~     outcome was felt to be secondary to non-compliance with treatment, and there was no decrease~     in the number of neuropsychiatric symptom exacerbations in this group. In a study comparing~     azithromycin and penicillin, both drugs were completely effective in preventing streptococcal~     infections - there were no documented titer elevations during the year-long study period for~     children taking either penicillin or azithromycin. Comparable reductions in the severity of~     tics and obsessive-compulsive symptoms were also observed. Thus, penicillin was not~     performing as an active placebo as originally postulated, but rather provided effective~     prophylaxis against Group A beta-hemolytic streptococcal. Both azithromycin and penicillin~     appear to be effective in eliminating GABHS infections, and reducing neuropsychiatric symptom~     severity; thus, between-group differences are negligible. Since increasing the n to~     demonstrate superiority of one prophylactic agent over another would be impractical, we have~     amended the study design to address two issues:~        1. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo~          in prolonging periods of remission among children in the PANDAS subgroup.~        2. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo~          in improving overall symptom severity for obsessive-compulsive symptoms and tics among~          children in the PANDAS subgroup.~      Because penicillin has a narrower therapeutic index and is less expensive than azithromycin,~     it is the preferable prophylactic agent. Further, penicillin (250 mg orally twice a day) has~     a long history of providing safe and effective prophylaxis for rheumatic fever and is the~     first line oral therapy recommended by the American Heart Association. Thus, penicillin has~     been chosen as the prophylactic antibiotic in the present study. Blister packs are used to~     increase compliance and to allow for easier documentation of missed doses.~   "
274693|NCT00001357|"~     This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated~     dose (MTD) for an outpatient regimen while exposing the minimum number of patients to a dose~     less than MTD. The anticipated accrual will be approximately 15 patients and the study will~     take one year to complete. Patients will receive Proleukin® (Registered Trademark)~     subcutaneously at their assigned dose level once per day for 5 days approximately every eight~     weeks for a total of 6 months. A cycle of therapy is defined as 5 days of Proleukin®~     (Registered Trademark) plus antiviral therapy followed by 7 weeks of antiviral therapy alone.~     If tolerated, each patient will receive 3 cycles of therapy and, following completion of~     three cycles, will be eligible for extended treatment. IL-2 injections will be delivered by~     study personnel on an outpatient basis for at least the first cycle of therapy.~   "
274694|NCT00001356|"~     This study will determine what growth factors are involved in promoting and inhibiting~     mastocytosis-an abnormal increase of mast cells in one or more organ systems. Mast cells~     release chemicals that can cause itching, blisters, flushing, bone pain, and abdominal pain.~     Little is known about the disease and there is no cure. Steroids and antihistamines can help~     reduce some symptoms.~      Patients from birth to 80 years of age with increased mast cells in at least one organ system~     may be eligible for this 3-year study. Family members may also be enrolled for genetic~     testing.~      Patients will be evaluated yearly at the NIH Clinical Center with the following tests and~     procedures:~        -  Medical history and physical examination.~        -  Blood samples.~        -  Laboratory blood tests, as medically indicated.~        -  Bone marrow aspiration and biopsy - For the bone marrow aspiration and biopsy, the back~          hipbone is punctured with a sterile needle. Five milliliters (1 teaspoon) of marrow is~          withdrawn through a syringe and a 1/2-inch piece of tissue is extracted with a special~          needle.~      The blood and bone marrow samples will be used for clinical care and for research to~     determine if mastocytosis is due to mast cell growth factors or genetic changes.~      Patients who require further evaluation and tests will have recommendations made to their~     primary physician. Any patient who requires immediate treatment will be admitted to the~     hospital. Standard medical treatment may include antihistamines for itching; steroids for~     severe abdominal symptoms such as cramping, diarrhea, and evidence of increased mast cells~     determined by an upper GI study; and adrenaline for anaphylactic shock. Patients who do not~     respond to conventional treatment may be offered participation in an experimental therapy~     study.~      Participating family members will have a medical history and a blood sample drawn to look for~     genetic abnormalities.~   "
274710|NCT00001329|"~     Brain and nerve cells communicate with each other by releasing and picking up chemicals~     called neurotransmitters. Norepinephrine is a neurotransmitter used by part of the nervous~     system activated during stress called the sympathetic nervous system. The sympathetic nervous~     system is involved with regulating blood pressure and pulse rate. Researchers believe the~     level norepinephrine in the blood can be used to measure activity of the sympathetic nervous~     system.~      This study is designed to answer important questions about rates of release of norepinephrine~     into the blood stream, removal of released norepinephrine, and the sympathetic nervous system~     response to stress.~      Researchers will attempt to measure levels of norepinephrine and activity of the sympathetic~     nervous system in patients with high blood pressure, normal patients with family histories of~     high blood pressure, patients taking drugs that can effect levels of norepinephrine, and~     patients with diseases or conditions directly affecting the sympathetic nervous system.~   "
275386|NCT00000266|"~     The purpose of this study is to evaluate the safety and efficacy of flupenthixol for cocaine~     dependence in individuals with schizophrenia/schizoaffective illness.~   "
274695|NCT00001355|"~     This protocol is designed to evaluate selected patients with documented recurrent or unusual~     infections and their family members for clinical and laboratory correlates of immune~     abnormalities. It allows long term follow up of patients with host defense defects and~     permits the periodic study of their blood, urine, saliva, skin, stool and vaginal specimens~     or wound drainage from such patients or their family members for medically indicated purposes~     and research studies related to understanding the genetic and biochemical bases of these~     diseases. This protocol may help provide patients and materials for the development of~     therapies for these diseases.~      This study will:~        1. Determine the biochemical and genetic causes of inherited immune diseases affecting~          phagocytes (white blood cells that defend against bacterial and fungal infections)~        2. Try to develop better ways to diagnose and treat patients with these diseases, and to~          prevent, diagnose and treat their infections~      Patients and family members may undergo the following procedures:~        -  A personal and family medical history, physical examination and other procedures, which~          may include various blood tests; urinalysis; saliva collection; imaging studies such as~          chest X-ray, computed tomography (CT) or magnetic resonance imaging (MRI); and lung~          function studies, dental examination or eye examinations, if medically indicated.~        -  Patients who have draining wounds will have fluid collected from these wounds for~          biochemical study.~        -  Tissues removed as part of medical care, such as pieces of lung, liver, or teeth, or~          biopsies of these tissues will be studied.~        -  Patients who have an immune problem that investigators wish to study further will be~          asked to return to NIH for follow-up visits at irregular intervals, but at least every 6~          months. The visits will include an updated medical history, examination directed at the~          particular medical problem related to the immune disorder, follow-up of abnormal tests~          or treatment, and collection of blood, saliva, urine, or wound fluid for study.~        -  Patients may have genetic testing and must be willing to have specimens stored for~          future research.~        -  Family members will have a medical history, saliva or urine collection, and chest X-ray~          or other imaging study, if medically indicated.~        -  Normal volunteers who have had tissue biopsies or pieces of tissue removed as part of~          medical care, such as pieces of lung, liver, or teeth, will have these tissues studied.~        -  NIH does not cover the cost of the initial screening visit for travel or lodging. A~          financial assessment may determine if the patient is eligible for financial assistance.~          This study does not enroll children under the age of 2.~        -  Patients will be asked to obtain their medical records, previous test results, or~          imaging studies prior to the first visit.~   "
274696|NCT00001354|"~     Certain patients who are participating in NIH protocols involving interleukin-2 (IL-2)~     therapy for HIV disease may be requested to have the following changes or additions to their~     study protocol:~        -  3-day subcutaneous (sc) IL-2 administration: Patients currently receiving IL-2~          intravenously (injections through a vein) may switch to subcutaneous administration~          (injections under the skin). Injections are given twice a day for 3 to 5 days (one~          treatment cycle), with cycles repeated no more often than every 8 weeks.~        -  Home treatment of sc IL-2: Home administration of IL-2 injections involves less frequent~          data and safety monitoring and no medical evaluations at the Clinical Center except at~          the beginning of each cycle. Participants will receive IL-2 cycles on the same schedule~          they followed in their original protocol. They will be seen at the Clinical Center at~          regularly scheduled follow-up visits between cycles and for a medical evaluation and~          blood drawing before the start of each cycle to determine the safety of administering~          the next cycle. During the home cycle, the patient's case manager or other team member~          will place monitoring telephone calls on days 2 and 4 of the cycle and again a week~          later. The timing and number of these calls may change depending on the findings of~          ongoing assessments of their usefulness. Patients will be required to notify the study~          team promptly of complications or other problems that develop with therapy.~        -  Stored specimens and HLA testing: Stored blood and tissue samples from patients will be~          used for future research on HIV, AIDS and related medical conditions, and the immune~          system. The samples may be labeled with no identifying information, with identifying~          information, such as the patient's name, or with a code that only the study team can~          link to the patient. Some of the blood drawn may be used for HLA typing, a genetic test~          of markers of the immune system. Usually used to match bone marrow or organ transplants,~          HLA type might also be used to try to identify factors associated with the progression~          of HIV disease or related conditions. Determining HLA type is also necessary to be able~          to perform certain research studies.~        -  Tonsillar biopsy: Examination of tonsil tissue may provide information on the effects of~          IL-2 on the immune system and the expression of HIV. Patients in the randomized IL-2~          study (93-CC-0113) may have tonsillar biopsies done up to three times-soon after~          enrollment, after month 4, and after month 12. Patients in the open IL-2 study~          (91-CC-0143) would have procedures no more often than every 3 months, with the following~          exception: patients in either study who are willing to have repeat biopsies performed~          during IL-2 therapy will have the procedure done up to three times during a round of~          IL-2: before Il-2 therapy, day 2-3 or IL-2 therapy, and day 4-6 of IL-2 therapy, if the~          sequential biopsies can be safely performed. The area to be biopsied will be numbed with~          a local anesthetic and 1 to 2 small pieces of tissue will be biopsied.~        -  Skin biopsy: Examination of skin tissue may help to explain how IL-2 causes changes in~          the skin. Biopsies will be obtained from areas of the skin that have been affected by~          IL-2 as well as from normal, unaffected areas for comparison. Patients with Kaposi~          sarcoma will also have biopsies of normal skin to allow comparison with IL-2-induced~          changes in the Kaposi sarcoma lesions. The areas to be biopsied will be numbed with~          local anesthetic and a 2-mm (1/10th-inch) piece of skin will be biopsied from each site.~   "
274697|NCT00001353|"~     This study will evaluate the safety of giving lymphocytes (white blood cells) containing a~     new gene to HIV-infected individuals and will determine how long the cells survive in the~     bloodstream. Although the genetically altered cells will not directly benefit participants,~     knowledge about the safety, side effects and survival of these gene-marked cells in~     HIV-infected patients may lead to new treatment strategies.~      Identical twin pairs 18 years of age and older-one infected with HIV, the other~     non-infected-may be eligible for this study. Candidates will be screened with a medical~     history, physical examination and blood tests.~      All participants will have a tetanus booster shot. Non-infected twins will undergo a~     procedure called apheresis to collect white blood cells. For this procedure, whole blood is~     collected through a needle in an arm vein, similar to donating blood. The blood is separated~     it into its components by centrifugation (spinning), the white cells are removed, and the~     rest of the blood is returned to the body, either through the same needle or through another~     needle in the other arm. The harvested white cells will be grown in culture for approximately~     10 days to 2 weeks to increase their numbers up to 1000-fold. A gene called NeoR, which is~     derived from bacteria, will be inserted into the cells, and these gene-marked cells will be~     infused into the HIV-infected twin.~      HIV-infected twins will be admitted to the NIH Clinical Center for the first cell infusion.~     The gene-marked cells will be infused over a 60-minute period through a plastic tube~     (catheter) placed in an arm vein, or, if a suitable arm vein cannot be found, through a~     special catheter placed into a large vein in the neck or chest. Vital signs (temperature,~     pulse, blood pressure and breathing rate), blood oxygen concentration, and urine output will~     be monitored regularly for 24 hours. Blood samples will be collected before and after the~     infusion to monitor for gene-marked cells. Patients will be discharged the next day. They~     will return to NIH daily the first week (from Monday through Thursday) to monitor for CD4~     cell counts, plasma viral burden, p24 antigen levels, HIV levels and the presence of the NeoR~     gene, and then weekly for the next 5 weeks for these tests and others to monitor blood and~     urine chemistry, blood counts and immune function markers.~      If the NeoR gene cannot be detected after the first cell infusion, the entire procedure~     (donor apheresis, gene marking and infusion of cells) will be repeated twice-about once every~     6 weeks. If the first infusion was uncomplicated, the second and third infusions may be done~     on an outpatient basis, with monitoring for 6 hours rather than 24. Six weeks after the third~     infusion, tests will be scheduled monthly for 6 months and then yearly for long-term~     follow-up.~      In addition to the above procedures, patients with a baseline CD4 lymphocyte count less than~     100 cells per cubic millimeter of blood will be asked to undergo apheresis periodically to~     obtain the most accurate results for determining how long the NeoR gene persists in the~     blood. The procedure will be done weekly for the first 6 weeks after each infusion of cells,~     then at week 8, and then every 4 weeks until the gene can no longer be detected in the~     lymphocytes. The schedule may change, but will not require more frequent apheresis.~   "
274698|NCT00001352|"~     This 5-year study will follow the course of disease in previously healthy patients with~     cryptococcosis who developed the disease for no identifiable reason.~      Individuals with a positive culture of Cryptococcus neoformans 18 years of age and older~     without HIV infection or other condition predisposing to cryptococcosis (such as high-dose~     corticosteroid therapy, sarcoidosis, or a blood cancer) may be eligible for this study.~     Candidates who test positive for HIV infection may not participate.~      Participants will have a physical examination, medical history, routine blood tests and~     assessment of disease activity upon entering the study. Patients who may have active~     cryptococcosis will also have a lumbar puncture (spinal tap) and additional blood tests.~     Following the initial evaluation, patients receiving treatment for cryptococcosis will come~     to the NIH Clinical Center as needed to manage their disease, typically no less than every 3~     months. Other patients will be seen every 6 to 12 months. The visits will include a medical~     history, physical examination, and blood and urine tests.~   "
274699|NCT00001351|"~     This study will investigate inflammatory diseases and disorders. Inflammation is the body s~     immune response to many things, including infections and other acute or chronic irritants. It~     may also be a sign of abnormal immune function. This study will allow evaluation and~     long-term follow-up of such disorders to:~        -  Establish and maintain a group of patients that may be eligible for other NIAID~          protocols.~        -  Provide clinical training and experience for NIAID fellows.~        -  Provide a mechanism for NIAID staff to maintain their clinical skills.~        -  Serve as a starting point for new investigations of syndromes not currently under study.~      Patients between 1 and 80 years of age with acute or chronic inflammation, including but not~     limited to viral, fungal or bacterial infections, or abnormal immune responses may be~     eligible for this study. Immediate family members of patients may also be enrolled for~     preliminary examination to see if they are affected in any way that may warrant further~     investigation.~      All patients and family members will have a history, physical examination and laboratory~     tests. Depending on the results, family members may require additional tests. Patients will~     have additional diagnostic tests indicated for their specific disease, according to accepted~     medical standards. These may include routine blood and urine tests, X-rays or other imaging~     studies, body fluid or tissue cultures, skin tests for allergic or immune responses, and~     others as needed.~      Treatments will include only medications approved by the Food and Drug Administration~     according to accepted dose schedules and delivery methods.~      Patients may be requested to donate extra blood for research studies. No more than 450 cc (30~     tablespoons) will be drawn from adults within a 6-week period, and no more that 7 cc (1/2~     tablespoon) from children under 18 years of age in the same time period.~   "
274700|NCT00001350|"~     The purpose of the protocol is to allow for patients, and relatives of patients, who may have~     the newly described autoimmune lymphoproliferative syndrome, to be evaluated at the NIH~     Clinical Center. This evaluation will include blood and relevant tissue studies along with~     long-term clinical evaluations to define the biology, inheritance,clinical spectrum, and~     natural history of this syndrome. The aim of the research is to understand mechanisms~     involved in the development of expanded numbers of what is typically a rare population of~     immune cells (CD4-8-/TCRalpha/beta+ T cells, otherwise referred to as double negative T~     cells), and how these relate to the development of expanded numbers of immune cells and~     autoimmune (self against self) responses in patients with ALPS.~      In some cases, we may proivide treatment related to ALPS. These treatments are consistent~     with standard medical practice.~      Participants with ALPS will be invited to visit the NIH once a year or more frequently when~     clinically indicated for the next few years for clinicians and scientists to follow the~     course of their disease and to manage its complications. Knowledge gained from these studies~     provides important insights into the mechanisms of autoimmunity, the thymus gland, and the~     role that the immune system and genetics plays in ALPS.~      Autoimmune lymphoproliferative syndrome is a rare disease that affects both children and~     adults. Each of these three words helps describe the main features of this condition. The~     word autoimmune (self-immune) identifies ALPS as a disease of the immune system. The tools~     used to fight germs turn against our own cells and cause problems. The word~     lymphoproliferative describes the unusually large numbers of white blood cells (called~     lymphocytes (stored in the lymph nodes and spleens of people with ALPS. The word syndrome~     refers to the many common symptoms shared by ALPS patients.~      One of the causes of ALPS is defective apoptosis, or said another way, an individual has an~     abnormality in how well lymphocytes (immune cells) die when they are instructed to do so. It~     is normal for lymphocytes to disintegrate (e.g., die) when they have done their job. In~     people with ALPS and in some of their affected relatives, the genetic message for the cells~     to die is altered: the message is not received and the cells do not die when they should. As~     a result, people with ALPS develop an enlarged spleen, liver and lymph glands, along with a~     range of other problems involving white blood cell counts and overactive immune responses~     (autoimmune disease). Some patients have an increased risk of developing lymphatic cancers~     (lymphoma).~      Provided is a description of eligible study candidates:~        1. Any patient with ALPS, male or female and of any age. As a patient with ALPS, candidates~          must have:~             -  a medical history of an enlarged spleen and/or enlarged lymph nodes over an~               extended period of time (past and/or current).~             -  defective lymphocyte apoptosis, in vitro.~             -  greater than or equal to 1 percent TCR alpha/beta+CD4-8- peripheral blood T cells.~        2. Relatives (any age) of patients and normal controls (18-65).~        3. Healthy normal volunteers will also be enrolled to provide data on normal cell behavior~          for comparison with patients.~      Additional information regarding ALPS and the research being conducted at the National~     Institutes of Health is available at the following World Wide Web (e.g., Internet) locations:~      http://www.niaid.nih.gov/publications/alps/~      http://www.nhgri.nih.gov/DIR/GMBB/ALPS/.~   "
274701|NCT00001349|"~     This study will collect blood plasma and white blood cells for laboratory research using a~     procedure called apheresis. Apheresis is a method of collecting larger quantities of certain~     blood components than can safely be collected through a simple blood draw.~      Patients 7 years of age and older with a parasitic infection or condition associated with a~     parasitic infection (i.e., elevated levels of IgE antibodies or of a type of white cell~     called eosinophils) who are currently enrolled in a NIH clinical research protocol may be~     eligible for this study. Relatives of patients and normal healthy volunteers will also be~     enrolled. Candidates will have a medical history, physical examination and blood tests.~     Individuals weighing less than 25 kilograms (55 pounds) may not participate.~      Participants will undergo one of the following two apheresis procedures:~        -  Automated pheresis Whole blood is drawn through a needle placed in an arm vein and~          circulated through a cell separator machine. The plasma (liquid part of the blood) and~          white cells are extracted, and the red cells are re-infused into the donor through a~          needle in the other arm. The procedure takes 1 to 2 hours.~        -  Manual pheresis Whole blood is drawn through a needle placed in an arm vein and~          circulated through the cell separator machine. The red blood cells are separated from~          the rest of the blood and returned to the donor through the same needle. Usually only~          one needle stick is required and the procedure takes from 30 to 45 minutes. This method~          is used only in individuals who weigh less than 35 kg (77 pounds).~   "
274709|NCT00001331|"~     The purposes of this study are to identify gene mutations in patients with the muscle~     diseases phosphofructokinase (PFK) deficiency, acid maltase deficiency (GAA deficiency) and~     to learn more about how these diseases develop. PFK deficiency is a mild, exercise-related~     illness. The childhood form of GAA deficiency (Pompe disease) affects the heart and liver and~     is rapidly fatal. The adult form begins in midlife and involves degeneration of skeletal~     muscles, leading to weakness and muscle wasting.~      The following groups of individuals may be eligible for this study:~      Group A: Patients with PFK deficiency, acid maltase deficiency, and relatives who also are~     affected. Participants in this group will undergo a brief medical and family history, blood~     sample collection, and possibly a physical examination, review of medical records, and~     interview with the patient's physician.~      Group B: Unaffected family members of patients in group A, including both blood relatives and~     spouses. People in this group may be asked to provide a history and genetic information. A~     review of medical records, interview with the individual's physician, and blood sample may~     also be requested.~      Group C: Control subjects. This group will provide a small blood sample or buccal mucosal~     sample (tissue sample collected by brushing the inside of the cheek). The samples will be~     coded and the investigators will not know the participants' identities. DNA from these~     samples will be analyzed for frequency of gene mutations.~      Genetic counseling will be arranged for patients, as appropriate.~   "
274702|NCT00001347|"~     The purpose of this investigation is to gain additional knowledge about what causes type 1~     and type 2 Usher syndrome-inherited diseases that can cause balance problems and impaired~     hearing and vision-and to develop better diagnostic tests. Patients with type 1 Usher~     syndrome usually are deaf from birth and have speech and balance problems. Patients with type~     2 disease generally are hearing impaired but have no balance problems. All patients develop~     eye problems that cause difficulty seeing in the dark.~      The development of newer and more sophisticated diagnostic tests may detect subtle~     differences in signs and symptoms that allow more accurate distinction between the two types~     of Usher syndrome. This study will use these tests to classify these syndromes and eventually~     identify the genes responsible for them.~      Study participants will have a medical and family history taken and a family tree~     constructed. They will undergo a thorough eye examination, including special tests of color~     vision, field of vision, and ability to see in the dark. An electroretinogram will be done to~     measure the function of cells in the retina, and a procedure called fluorescein angiography~     will be done to look at and photograph the blood vessels in the retina. Special hearing and~     balance tests will also done. Hearing tests include physical examination of the ears and~     wearing earphones while listening to tones. Balance and coordination tests require tasks such~     as walking in a straight line and standing in the dark with eyes closed. A caloric~     stimulation test will also be done, in which a small amount of water is irrigated into the~     ear canal. For gene studies, blood samples will be collected from patients and all available~     family members.~   "
274703|NCT00001345|"~     Diseases of mineral metabolism such as familial multiple endocrine neoplasia type 1 (FMEN1),~     familial hypocaliuric hypercalcemia (FHH), familial hyperparathyroidism (FH), and~     pseudohypoparathyroidism (PHP) are known as hereditary abnormalities. Meaning these~     conditions are passed from parents to their children through genes. These specific conditions~     result in abnormal levels of calcium in the blood.~      This study was designed to help researchers understand more about the genes that are~     responsible for these disorders. By learning more about the genetic process involved in~     hereditary abnormalities, new tests and treatments can be developed.~      Subjects for this study will be members of families that have had relatives diagnosed with a~     disease of mineral metabolism. Participants will be asked to give blood samples for DNA~     extraction. DNA is the part of cells that carries genetic information.~      The DNA will be analyzed and the results given to the subjects. Genetic counseling will be~     provided to subjects to aid in interpreting their results.~   "
274704|NCT00001343|"~     Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes.~     Patients with Turner syndrome are typically short, have abnormal physical features, and lack~     the physical changes normally associated with puberty. In addition, some patients with Turner~     syndrome have low bone density (osteoporosis) and differences in learning abilities.~      This study will research the effects of steroid hormones on patients with Turner syndrome. It~     will look closely at how taking steroid hormones effects the patient's rate of growth as well~     as the patient's ability to learn. In addition the study will investigate how different~     hormones (androgen and estrogen) work when given together as a combination.~      All patients asked to participate in this study will receive growth hormone injections.~     However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in~     the form of a pill. The other half of the patients will receive a placebo or sugar pill.~     This will allow the researchers to determine if the combination of the hormones produces~     different results than growth hormone alone.~      The study will last approximately 2 years. After 2 years of research the patients may qualify~     for an additional 2 years of treatment. Patients may benefit directly from this research with~     increased growth and improved ability to learn.~   "
274705|NCT00001339|"~     Patients who have no response to preoperative chemotherapy and no residual disease following~     surgery on Regimen A are treated on Regimen B postoperatively.~      The following acronyms are used:~      DDD Mitotane, NSC-38721~      DOX Doxorubicin, NSC-123127~      VCR Vincristine, NSC-67574~      VP-16 Etoposide, NSC-141540~      Regimen A: 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination~     Chemotherapy. DDD/DOX/VCR/VP-16; followed by surgical debulking; followed by~     DDD/DOX/VCR/VP-16.~      Regimen B: Single-Agent Chemotherapy. DDD.~   "
274706|NCT00001337|"~     5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. EPOCH: Etoposide,~     VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574;~     Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte~     Colony-Stimulating Factor (Amgen), G-CSF, NSC-614629.~   "
274707|NCT00001336|"~     Peripheral blood mononuclear cells (PBMC) will be collected from patients who have leukemia~     or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or~     immunological function. These PBMC will be assessed for cellular markers by flow cytometry~     and will be studied for in vitro T helper, effector and suppressor cell functions, to~     determine whether cell mediated immunity is involved in the condition, or indicative of~     therapeutic efficacy or is predictive for outcome. Peripheral blood stem cells (PBSC) from~     untreated donors and from cytokine treated donors will be assessed for cellular markers and~     in vitro growth characteristics that might be useful for identifying normal stem cell~     populations.~   "
274708|NCT00001335|"~     The prognosis for patients with metastatic Ewing's sarcoma family of tumors (ESF),~     rhabdomyosarcoma (RMS), and neuroblastoma (NBL) remains dismal, with less than 25% long-term~     disease-free survival. Though less grave, the prognosis for cure for other high-risk patients~     is approximately 50%. New treatment strategies, including the identification of highly active~     new agents, maximizing the dose intensity of the most active standard drugs, and the~     development of improved methods of consolidation to eradicate microscopic residual disease,~     are clearly needed to improve the outcome of these patients. This protocol will address these~     issues by commencing with a Phase II window, for the highest risk patients, to evaluate a~     series of promising drugs with novel mechanisms of action. All patients will then receive 5~     cycles of dose-intensive best standard therapy with doxorubicin (adriamycin), vincristine,~     and cyclophosphamide (VAdriaC). Patients at high risk of relapse will continue onto a phase I~     consolidation regimen consisting of three cycles of dose-escalated Melphalan, Ifosfamide,~     Mesna, and Etoposide (MIME). Peripheral blood stem cell transfusions (PBSCT) and recombinant~     human G-CSF will be used as supportive care measures to allow maximal dose-escalation of this~     combination regimen.~   "
274711|NCT00001328|"~     Malignant brain tumors are responsible for a significant amount of deaths in children and~     adults. Even with advances in surgery, radiation therapy, and chemotherapy, many patients~     diagnosed with a malignant brain tumor survive only months to weeks.~      In an attempt to improve the prognosis for these patients, researchers have developed a new~     approach to brain tumor therapy. This approach makes use of DNA technology to transfer genes~     sensitive to therapy into the cells of the tumor.~      Infections with the herpes simplex virus can cause cold sores in the area of the mouth. A~     drug called ganciclovir (Cytovene) can kill the virus. Ganciclovir is effective because the~     herpes virus contains a gene (Herpes-Thymidine Kinase TK gene) that is sensitive to the drug.~     Researchers have been able to separate this gene from the virus.~      Using DNA technology, researchers hope to transfer and implant the TK gene into tumor cells~     making them sensitive to ganciclovir. In theory, giving patients ganciclovir will kill all~     tumor cells that have the TK gene incorporated into them.~   "
274712|NCT00001327|"~     The brain and spinal cord are surrounded by fluid called cerebrospinal fluid (CSF). The CSF~     flows through channels in the brain and around the spinal cord. Occasionally, people are born~     with malformations of these channels. Syringomyelia is a pocket within the CSF channels that~     results from abnormal CSF flow. Syringomyelia is associated with problems in the nervous~     system. Patients with syringomyelia may be unable to detect sensations of pain and heat. If~     the condition is not treated it can worsen.~      Treatment of this condition is surgical. It requires that the flow of CSF is returns to~     normal. There are many different treatment options, but no one procedure has been shown to be~     significantly better than any other.~      In this study, researchers would like to learn more about how the CSF pressure and flow~     contribute to the progression of syringomyelia. Ultrasounds and magnetic resonance imaging~     (MRI) will be used to evaluate the anatomy of the brain. Researchers hope that information~     gathered about anatomy and measures of CSF pressure and flow can be used later to develop an~     optimal surgical treatment for syringomyelia.~   "
274713|NCT00001325|"~     This study is designed to use positron emission tomography to measure brain energy use.~     Positron Emission Tomography (PET) is a technique used to investigate the functional activity~     of the brain. The PET technique allows doctors to study the normal processes of the brain~     (central nervous system) of normal individuals and patients with neurologic illnesses without~     physical / structural damage to the brain.~      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar~     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and~     water. Blood carries fuel to the brain and waste products away from the brain. As brain~     activity increases blood flow to and from the area of activity increases also.~      Researchers can label a sugar with a small radioactive molecule called FDG~     (fluorodeoxyglucose). As areas of the brain use more sugar the PET scan will detect the FDG~     and show the areas of the brain that are active. By using this technique researchers hope to~     answer the following questions;~      4. Are changes in brain energy use (metabolism) present early in the course of epilepsy~      5. Do changes in brain metabolism match the severity of patient's seizures~      6. Do changes in metabolism occur over time or in response to drug therapy~   "
274714|NCT00001323|"~     The purpose of this study is to evaluate the cognitive processes of participants with~     schizophrenia, participants with nervous system and mental disorders, and healthy volunteers.~      Participants in this study will undergo cognitive tests of attention, memory, attention.~     Participants with attention deficit hyperactivity disorder (ADHD), traumatic brain injury~     (TBI), bipolar disorder, and Alzheimer's disease (AD) will be compared with participants with~     schizophrenia. A group of healthy adults and children will undergo cognitive tests to further~     delineate the degree of impairment in schizophrenia and neurological disorder participants.~   "
274715|NCT00001322|"~     This study evaluates the effects of estrogen and progesterone on mood, the stress response,~     and brain function in healthy women.~      The purpose of this study is to evaluate how low levels of estrogen and progesterone (that~     occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen~     and progesterone (given during individual months of hormone add-back) on a variety of~     physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without~     PMS.~      This study will investigate effects of reproductive hormones by temporarily stopping the~     menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle~     hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.)~     will be performed during the different hormonal conditions (low estrogen and progesterone,~     progesterone add-back, estrogen add-back). The results of these studies will be compared~     between women without PMS and women with PMS (see also protocol 90-M-0088).~      At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy~     tests will be performed. Cognitive functioning and stress response will be evaluated during~     the study along with brain imaging and genetic studies.~   "
274716|NCT00001320|"~     Brain cells communicate with each other by releasing chemicals called neurotransmitters. In~     order for brain cells to transfer information, one cell will release a neurotransmitter that~     will be recognized by a receptor located on surface of another cell. One such~     neurotransmitter is dopamine.~      Abnormal dopamine transmission has been seen in patients with substance abuse and different~     neuropsychiatric disorders including schizophrenia.~      A radioactive drug called IZBM (I-123 iodobenzamide) can also bind to certain dopamine~     receptors. IZBM can be seen by Single Photon Emission Tomography (SPECT). Therefore, by using~     IZBM and SPECT scans, researchers can find and map the location of dopamine receptors in~     the brain.~      Patients participating in this study must also have been selected for other genetic studies~     being conducted at the NIMH. Patients with schizophrenia will be selected from a NIMH~     research study titled, Neurobiological Investigation of Patients with Schizophrenia Spectrum~     Disorders and Their Siblings (95-M-0150). Normal patient volunteers will be selected from~     another NIMH study titled, Inpatient Evaluation of Neuropsychiatric Patients (89-M-0160).~     All aspects of clinical care and genetic analysis of these patients will be covered in these~     studies, while information pertaining to IBZM SPECT scans will be covered in this study.~      This study will not directly benefit patients participating in it. However, information~     gathered may contribute to faster and more accurate diagnosis of schizophrenia and eventually~     better treatment for the disorder.~   "
275387|NCT00000265|"~     The purpose of this study was to characterize mood changes during nitrous oxide inhalation in~     patients with different levels of preoperative dental anxiety.~   "
274717|NCT00001319|"~     This study will evaluate HIV-negative patients with unusually low levels of CD4+ T~     lymphocytes (a type of white blood cell) to learn more about the clinical symptoms, cause,~     immunology, and biology of this problem. CD4+ T lymphocytes play an important role in immune~     function, and low counts may leave people susceptible to unusual infections. CD4+ T cell~     deficiencies are most often associated with HIV infection.~      Patients 8 years of age and older with CD4+ T cell counts below 300 cells/mm3 who test~     negative for HIV infection by standard blood tests may be eligible for this study. Patients'~     family members and partners may also be enrolled to investigate the possible role of a~     genetic factor or exposure to some agent in this problem.~      Patients will be evaluated at the NIH Clinical Center at least once, and generally two or~     more times. The evaluations, which may be done on an inpatient or outpatient basis, will~     include some or all of the following tests and procedures:~        -  Complete physical examination.~        -  Medical history, including questions about sexual contacts, intravenous drug use,~          travel, blood transfusions, previous illnesses, including sexually transmitted diseases,~          and health of family members.~        -  Urine test.~        -  Blood tests for routine and research purposes, including tests for HIV, hepatitis,~          syphilis and other infections, evaluation of immune function, and culture for viruses in~          the HIV family. No more than 1 pint of blood will be drawn every 6 weeks.~        -  Pregnancy test for women of childbearing potential.~        -  Skin tests for tuberculosis and immune function. These tests involve injecting a small~          amount of the substance to be tested just under the skin and looking for a raised area 1~          to 2 days later.~        -  Apheresis. Whole blood is collected through an arm vein (similar to donating blood), and~          circulated through a cell separator machine, where it is spun to separate the~          components. The red cells are then returned to the patient either through the same~          needle or through a needle in the other arm, and the plasma and white cells are~          extracted for study. The procedure, which takes 1 to 2 hours, may be repeated up to 3~          times.~      Family members will have 60 cc (4 tablespoons) of blood drawn to determine CD4+ T cell~     counts.~   "
274718|NCT00001316|"~     Our laboratory has previously demonstrated that lymph nodes are a major reservoir for human~     immunodeficiency virus (HIV) and a major site of active virus replication in infected~     individuals(1-3). There is at least a 10 fold greater viral burden per given number of CD4+ T~     lymphocytes obtained from the lymph nodes versus the peripheral blood in the same infected~     individual. These data have been accumulated predominantly in individuals with progressive~     generalized lymphadenopathy (CDC Class A1 and A2). It is unclear at present whether this~     pattern holds true for all categories of HIV infected individuals. We have proposed that the~     seeding of lymph nodes by HIV early in the course of HIV infection and the persistent~     production of virus in lymph nodes throughout the course of infection are major factors in~     the pathogenesis of HIV in virtually all infected individuals. In addition, it is likely that~     the selective perturbations of various T cell subsets (i.e., V-B classes of CD4+T cells) that~     have been observed in peripheral blood are much more dramatic in the lymph node given the~     greater viral burden in the lymph node compared to the peripheral blood. In order to~     investigate this hypothesis, it is essential that we study simultaneously lymph nodes and~     peripheral blood from the same individuals and that we study different individuals at various~     stages of disease from early in the course of infection (CDC Class A) to advanced disease~     (CDC Class B and C). If, as we suspect, there is active virus replication in the lymph node~     early in the course of infection, even at a time when there is little virus burden or active~     replication in the peripheral blood, this would justify anti-retroviral therapy at the~     earliest possible time in the course of infection. In addition, in certain patients who are~     about to initiate treatment with an anti-retroviral agent such as zidovudine or didanosine~     through their private physician, it would be important to know whether treatment actually~     reduces the viral burden and virus replication in lymph nodes. The effect of therapy on viral~     burden and replication will be compared in the lymph node versus peripheral blood mononuclear~     cells and both of these parameters will be compared with the level of plasma viremia.~   "
274719|NCT00001313|"~     In this study researchers will admit and evaluate patients with known or suspected heart~     disease referred to the Cardiology Branch of the National Heart, Lung, and Blood Institute~     (NHLBI).~      Patients participating in this study will undergo a general medical evaluation, including~     blood tests, urine, examination, chest x-ray and electrocardiogram (EKG). In addition,~     patients may be asked to have an echocardiogram (ultrasound scan of the heart) and to perform~     an exercise stress test.~      These tests are designed to assess the types and causes of patient's heart diseases and to~     determine if they can participate in other, specific research studies.~   "
274720|NCT00001310|"~     The purpose of this project is to diagnose and evaluate ocular and related tissues with~     various diseases such as conjunctival, corneal, uveal, vitreoretinal and optic nerve~     disorders, ocular degenerative, metabolic or genetic diseases and tumors. These will be~     studied using light microscopy, electron microscopy, confocal microscopy,~     immunohistochemistry, molecular pathological including polymerase chain reaction and in situ~     hybridization, as well as measuring the functions of cellular organelles, e.g., mitochondrial~     function. Lymphocytes in the peripheral blood as well as other involved biopsied tissues and~     ocular tissue will be compared and categorized by disease. Cytokines, chemokines or growth~     factors and/or other released molecules in the blood and ocular fluids will be also analyzed.~     Elucidating the relationship between the infiltrating cells, ocular resident cells, and their~     products in various diseases will help us to make diagnoses and increase our understanding of~     human ocular disorders.~      Patients who require eye surgery to treat an eye disease or other disease in which the eye is~     involved may participate in this study. Samples of eye tissue and fluid that are normally~     removed and discarded during eye surgery will instead be given to researchers for study. The~     tissues will be examined under microscope and studied using sophisticated chemical and~     biological tests. Immune cells from blood samples may also be examined. These studies will~     help better understand and diagnose the various eye diseases and to develop more attractive~     therapies.~   "
274721|NCT00001309|"~     Pharmacokinetics is the term used for how the body affects a drug once it is taken. Vitamin~     C, also known as ascorbic acid, is an essential water soluble vitamin. Meaning, the body does~     not make Vitamin C it must be taken in through the diet. In this study researchers will~     attempt to determine how the amount of water consumed affects the level of vitamin C in the~     blood (specifically the plasma component of the blood).~      In this study researchers will take 13 subjects and place them on a Vitamin C restricted~     diet. Vitamin C levels will be measured twice a week on an outpatient basis until all~     subjects reach a desired low level of Vitamin C (12-15 micromolar plasma ascorbic acid~     concentration). Subjects will then be admitted and undergo 24 hour blood and urine~     collection. Following the collection of samples, subjects will then begin to receive Vitamin~     C orally (by mouth) and intravenously (injected into the vein). The dosage of Vitamin C will~     gradually increase from 30 mg-2500 mg divided into two daily doses. Blood and urine samples~     will be collected each time the dose is increased. The study will take approximately 18 weeks~     after which the subjects will be discharged in healthy condition.~   "
274749|NCT00001254|"~     This protocol concerns the approach to the localization, diagnosis of MEN1 and management of~     the tumor and the tissue samples in patients with Zollinger-Ellison syndrome. It details the~     diagnostic imaging tests to be used to localize the tumor, investigations for MEN1 the~     subsequent management of the tumor and tissue samples for research.~   "
274869|NCT00000452|"~     The long-range goal of this ongoing research program is to find more effective treatments for~     alcohol dependence by combining medication with the appropriate psychosocial support. This~     proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in~     three types of treatment settings; (2) to assess the effects of psychosocial support on~     medication compliance and treatment retention; and (3) to investigate the individual~     characteristics that may predict who is likely to benefit from additional psychosocial~     support versus simple medication management.~   "
274722|NCT00001308|"~     Positron Emission Tomography (PET) is a technique used to investigate the functional activity~     of the brain. The PET technique allows doctors to study the normal biochemical and metabolic~     processes of the central nervous system of normal individuals and patients with neurologic~     illnesses without physical / structural damage to the brain. Radioactive water H215O in PET~     scans permits good visualization of areas of the brain related to speech.~      Most of the PET scan studies conducted have concentrated on learning about how language is~     formed and decoded. Few studies have been conducted on speech production. This study aims to~     use radioactive water (H215O) and Positron Emission Tomography (PET scan) to measure blood~     flow to different areas of the brain in order to better understand the mechanisms involved in~     speech motor control.~      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar~     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and~     water. Blood carries fuel to the brain and waste products away from the brain. As brain~     activity increases blood flow to and from the area of activity increases also. Knowing these~     facts, researchers can use radioactive chemicals (H215O) and PET scans to observe what areas~     of the brain are receiving more blood flow.~      Researchers will ask patients to perform tasks that will affect speech, voice, and language.~     At the same time patients will undergo a PET scan. The tasks are designed to help researchers~     observe the blood flow to brain areas associated with voicebox (laryngeal) functions,~     movement of muscles in the jaw, tongue, and mouth, and other aspects of motor speech.~      Special studies will be conducted to evaluate how certain therapies and tasks can draw out~     symptoms in illnesses in which speech and language are affected. Results of these tests will~     be used in other studies to evaluate the neurologic mechanisms of diseases like Tourette's~     syndrome and parkinson's disease.<TAB>...~   "
274723|NCT00001307|"~     This study will examine how the brain processes pain signals and how the different parts of~     the brain work with each other in response to painful stimuli. A better understanding of how~     people experience pain may be helpful in developing more effective treatments.~      Healthy normal volunteers, patients requiring third molar (wisdom tooth) extraction, and~     patients with persistent pain due to disease, injury or other reason may be eligible for this~     study.~      Participants will receive one or more of the following sensory stimuli, which may cause brief~     discomfort or pain:~        -  Heat/Cold - applied by an electronically controlled device that touches the skin, or by~          temperature-controlled water baths, or by a thermally controlled brass cylinder the~          subject grasps~        -  Capsaicin (active ingredient in hot chili peppers) - injected in a small volume of fluid~          under the skin or into a muscle~        -  Mechanical stimulation - brushings or vibrations that do not normally cause pain~        -  Ischemic stimulation - inflation of a blood pressure cuff on the arm or leg for up to 30~          minutes~      These stimuli will be applied both before and during positron emission tomography (PET)~     scanning. This test shows which parts of the brain are active and which are not and is~     important for studying how different parts of the brain work together to feel and react to~     specific sensations. For this procedure, the subject lies on a table in the PET scanner while~     a series of scans are taken during different sensory conditions. At the beginning of each~     scan, radioactive water is injected into an arm vein through a catheter (a thin plastic~     tube). A special camera records the arrival and disappearance of the radiation in various~     brain areas, creating a picture of the brain's activity in various regions. Oral surgery~     patients may have PET scans both before and after their wisdom tooth extraction. Alfentanil,~     a commonly used narcotic pain reliever, will also be given during the PET procedure to~     determine how the brain responds to sensory stimuli while under the effects of a pain killer.~      Participants will also have a magnetic resonance imaging (MRI) scan of the brain to help~     interpret the PET results. MRI uses a magnetic field and radio waves to show structural and~     chemical changes in tissues. During the scan, the subject lies on a table in a cylindrical~     machine (the scanner). He or she can speak with a staff member via an intercom system.~      Some sensory studies may require placing an arterial and/or intravenous line. Following~     injection of a local anesthetic, a catheter is placed in an artery in the arm. At regular~     intervals during various sensory stimuli, small blood samples are drawn from the artery to~     measure blood gases and other substances. Samples may also be drawn from a catheter placed in~     a vein.~      Subjects may also have ultrasound monitoring to evaluate blood flow in the arteries, veins~     and brain. A gel is spread over the skin above the blood vessel and a hand-foot-and-mouth~     device is placed on the gel. The device emits high-frequency sound waves to produce a picture~     of the speed of blood flow in the artery and the diameter of the vessel.~   "
274724|NCT00001306|"~     No therapy for infertile patients with premature ovarian failure has been proven effective.~     Some anecdotal reports have suggested that high dose, long term prednisone (steroid) therapy~     may be useful in treating autoimmune ovarian failure. However, prednisone, when used in~     high-doses for long periods of time has substantial side effects, including aseptic necrosis~     of bone where portions of bone die without the presence of infection and are surrounded by~     healthy tissue. Aseptic necrosis of bone often requires major surgical treatment. Even with~     this known level of risk, patients with premature ovarian failure are being treated based on~     this anecdotal evidence.~      This study will test the hypothesis that a lower risk therapy (alternate-day, lower dose,~     shorter-term prednisone) will cause a remission of autoimmune ovarian failure. There is no~     reliable blood test to identify patients who have premature ovarian failure. Therefore, all~     patients must undergo a laparoscopic ovarian biopsy to confirm the presence of an auto immune~     reaction in the ovaries (autoimmune oophoritis). Laparoscopy is a surgical procedure that~     allows doctors to explore the abdomen using a camera-like device called a laparoscope. The~     procedure has been used clinically by some reproductive endocrinologists to identify patients~     with premature ovarian failure who have an autoimmune mechanism for the disorder.~      The treatment will be deemed successful based on the return of ovulation as determined by~     weekly serum progesterone levels.~   "
274725|NCT00001305|"~     Growth deficiency is a key feature of severe Osteogenesis Imperfecta (OI) and a frequent~     feature of mild to moderate forms of the disease. The reason that children with OI are short~     is not fully understood. We do know that details such as the number of fractures suffered or~     the type of OI do not fully explain the short stature of OI. Growth patterns have been~     defined for children with OI Types I, III, and IV. At about 12 months of age, children with~     Types III and IV OI demonstrate a predictable plateau of their linear growth rate. Type IV OI~     children begin to resume a normal growth rate at about age four to five years, but they will~     not catch up to a normal height, as they have lost a significant period of growth. The~     plateau usually continues for children with Type III OI. The reason for this growth plateau~     is unknown. There have been no studies which evaluate the growth of OI children in this age~     range. Our previous studies of growth in OI children have begun at age 5 years.~      We have studied growth in OI children for the past 10 years. Different medications have been~     tried to both stimulate growth and improve bone density. Some children have responded to~     growth hormone (their growth rate increased by at least 50%) and some did not. The majority~     of children who did respond were Type IV. However, we need to carefully treat and study more~     children to try to determine which children will benefit from growth hormone medication.~      The Goals of this Study Are:~        1. We want to try to find a cause for the growth plateau common in types III and IV OI.~          Long-term, our goal is to develop a treatment to eliminate this plateau.~        2. We want to see how long and how well OI bone will respond to growth stimulation.~        3. We hope to find a predictor for who will respond to growth hormone and who will not,~          by measuring your child's endocrine and growth hormone function before receiving any~          growth hormone treatment.~        4. We want to measure the effects of growth stimulation on bone density, and the quality of~          OI bone.~        5. We want to see if there are long term benefits resulting from this treatment in the form~          of final adult height, trunk height, and possibly improved function of the respiratory~          system.~      Median Subject Age (on p. 1 of webpage): 1-15 years (replaces 0-20)~   "
274726|NCT00001304|"~     This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH)~     as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with~     calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients~     who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism~     to be managed effectively with the investigational drug, PTH. The primary goals of this study~     are to (1) provide long-term PTH therapy to patients who do not respond to conventional~     therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney~     function and bone mineral density; (3) study and track linear growth and bone accrual in~     children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone~     mass and if the timing of this is comparable to normal age-matched healthy controls.~   "
274727|NCT00001303|"~     Bacterial infections can progress to a life-threatening illness called septic shock,~     characterized by low blood pressure and vital organ damage. The syndrome is thought to be~     caused by parts of the bacteria and by the body s own immune response to the infection. A~     major bacterial product that interacts with the immune defenses is called endotoxin. This~     study will examine the body s response to endotoxin in the lungs or bloodstream. When~     endotoxin is given in small amounts to humans, even though it is not an infection, it~     triggers a set of responses that are typical of what one would see with a true bacterial~     infection. This allows us to study the earliest changes in molecules and cells that are~     involved in some bacterial infections. This type of model is safe and has been used in humans~     for many years to understand the body s responses during infections.~      Normal volunteers 18 to 45 years of age may be eligible for this study. Candidates will have~     a history and physical examination, blood and urine tests, electrocardiogram (EKG) and chest~     X-ray. In addition, volunteers 40 to 45 years old will have an exercise stress test to screen~     for asymptomatic coronary artery disease. Participants will undergo one or more of the~     following procedures:~      Bronchoscopy, Bronchoalveolar Lavage, Bronchial Brushings, and Endobronchial Mucosal~     Biopsies: These techniques for examining lung function are used routinely in patient care and~     clinical research. The mouth and nasal and lung airways are numbed with an anesthetic. A~     bronchoscope (pencil-thin flexible tube) is then passed through the nose into the large~     airways of the lung. Cells and secretions from the airways are rinsed with salt water~     (bronchoalveolar lavage) and a flexible brush the size of a pencil tip is passed through the~     bronchoscope to scrape cells lining the airways. Lastly, pieces of tissue (the size of the~     ball of a ballpoint pen) lining the airways are removed for examination under the microscope.~      Intravenous Endotoxin: A small dose of endotoxin is injected into a vein. Blood samples are~     drawn at regular intervals for 8 hours after the injection and again after 1, 2, 3, 7 and 14~     days to analyze the body s immune response to the bacteria in the blood.~      Instilled Endotoxin in the Lungs: A small amount (2 teaspoons) of salt water is squirted~     through a bronchoscope into a lobe of one lung, and then salt water containing a small dose~     of endotoxin is squirted into the other lung. Bronchial lavage, brushing, and biopsy (see~     above) are then done to study the response of the lung to the endotoxin. In addition, air is~     withdrawn through the bronchoscope to study air components from the lung that was instilled~     with salt water or endotoxin.~      Nitric Oxide Therapy: Endotoxin is instilled in a lung (see above) and then nitric oxide a~     colorless, odorless, tasteless gas mixed with room air in a concentration of 40 parts per~     million, is given through a cushioned mask placed over the mouth and nose. (Some participants~     will be given the nitric oxide mixture and others will breathe only room air through the mask~     to test the effects of the nitric oxide on the lung inflammation.) The mask will be worn~     continuously for 6 hours and removed before repeat bronchoscopy with lavage, brushing and~     biopsy.~      Some of the above procedures require placement of a catheter (thin plastic tube) in a wrist~     artery to monitor blood pressure from heartbeat to heartbeat and to collect blood samples.~     First, the skin is numbed with an anesthetic (lidocaine). A needle is then inserted into the~     artery, the catheter is slipped over the needle into the vessel, and the needle is removed.~   "
274728|NCT00001302|"~     The clinical study entitled A Phase I Study of Infusional Chemotherapy with the~     P-glycoprotein Antagonist PSC 833 seeks to determine the maximum tolerated dose for a~     proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is~     purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies~     to enhance chemosensitivity as well as cyclosporine and to be far better at increasing~     intracellular drug accumulation than the concentrations of verapamil which are clinically~     achievable. The purpose of this study is to define the maximum tolerated dose in combination~     with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine.~     PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent~     compound, cyclosporine. This effect will increase the area under the curve (AUC) of~     vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a~     conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8~     days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This~     first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent~     cycles both agents will be combined. Escalation of the PSC 833 will continue until a target~     concentration is reached, or until the maximum tolerated dose is reached. Clinical responses~     will be monitored in order to provide the best possible medical care to our patients.~   "
274729|NCT00001295|"~     This protocol is to provide continuing medical/surgical/radio-therapeutic care, treatment and~     follow-up for NCI patients not currently entered on an active research protocol. No~     investigational treatments will be administered on this protocol.~   "
275388|NCT00000264|"~     The purpose of this study is to examine the subjective, psychomotor, and reinforcing effects~     of combined alcohol and nitrous oxide intake in healthy volunteers.~   "
274730|NCT00001294|"~     We propose to test, by DNA linkage analysis of family pedigree members, the following~     interrelated hypotheses: 1) that sexual orientation is genetically influenced; 2) that the~     development of Kaposi's sarcoma and other outcomes of HIV infection in male homosexuals is~     affected by host susceptibility genes, circulating sex hormone levels, or HLA haplotype; and~     3) that alcoholism and other psychobehavioral conditions are associated with homosexuality on~     a genetic basis and/or influenced by candidate behavioral loci. The subjects for these~     studies will be self-identified male and female homosexual probands and their relatives from~     families in which there are at least two individuals with homosexual orientation. All~     subjects will be adults, and will be referred through NIH physicians, private practitioners,~     and gay and lesbian organizations. Subjects will undergo a sexual orientation and behaviors~     interview, a psychiatric interview, and phlebotomy for HIV testing, HLA determination,~     endocrine measurements, and preparation of DNA from cultured lymphocytes. The DNA samples~     will be analyzed for a series of genetic markers that span the human genome and for candidate~     loci chosen for function.~   "
274731|NCT00001289|"~     Gaucher disease is a lysosomal storage disease resulting from glycocerebroside accumulation~     in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in~     adults but occurs most severely in infants, in whom cerebroside also accumulates in neurons.~     Patients with Gaucher's disease experience enlargement of the liver and spleen and bone~     destruction. The condition is passed from generation to generation through autosomal~     recessive inheritance. There are actually three types of Gaucher's disease.~      Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease~     does not affect nerve cells. The symptoms of type I can appear at any age.~      Type II appears in infancy and usually results in death for the patient. Type II is an acute~     neuronopathic form and can affect the brain stem. It is the most severe form of the disease.~      Type III is also neuronopathic, however it is subacute in nature. This means the course of~     the illness lies somewhere between long-term (chronic) and short-term (acute).~      The purpose of this study is to examine the effects of enzyme replacement therapy on patients~     with Gaucher's disease, specifically those types directly affecting the nervous system~     (neuronopathic).~      Patients with Gaucher's disease types II and III will be selected to participate in the study~     and receive enzyme replacement therapy. Patients participating will undergo a variety of~     tests to measure levels of hemoglobin concentration, liver volume, and spleen volume.~     Improvements in these measures will be compared other laboratory tests measuring the~     involvement of the nervous system.~   "
274732|NCT00001288|"~     Positron Emission Tomography (PET) is a technique used to investigate the functional activity~     of the brain. The PET technique allows doctors to study the normal processes of the brain~     (central nervous system) of normal individuals and patients with neurologic illnesses without~     physical / structural damage to the brain.~      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar~     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and~     water. Blood carries fuel to the brain and waste products away from the brain. As brain~     activity increases blood flow to and from the area of activity increases also. Knowing these~     facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of~     the brain are receiving more blood flow.~      This study is designed to use positron emission tomography (PET) with radioactive water~     (H215O) to determine the areas of the brain associated with memory and language. Patients~     participating in the study will be made up of normal volunteers, patients with epilepsy, and~     patients with other abnormalities related to the surface of the brain (non-epileptic focal~     cortical dysfunctions).~   "
274733|NCT00001284|"~     The purpose of this study is to use brain imaging technology to compare differences in brain~     structure, chemistry, and functioning in individuals with brain and mental disorders compared~     to healthy volunteers.~      Schizophrenia is a brain disorder that results from subtle changes and abnormalities in~     neurons. These deficits likely occur in localized regions of the brain and may result in~     widespread, devastating consequences. The neuronal abnormalities are inherited through a~     complex combination of genetic and environmental factors. Brain imaging technologies can be~     used to better characterize brain changes in individuals with schizophrenia. This study will~     use magnetic resonance imaging (MRI) scans to identify predictable, quantifiable~     abnormalities in neurophysiology, neurochemistry and neuroanatomy that characterize~     schizophrenia and other neurological and neuropsychiatric disorders.~   "
274734|NCT00001282|"~     This study will evaluate the long-term toxicity and obtain preliminary information about~     long-term efficacy of the combination of antiretroviral therapies and interleukin-2 (IL-2), a~     cytokine with immunomodulatory properties. Currently 73 patients have been approved to~     receive IL-2 at a starting dose of 18 MIU/d for 5 days. Multiple courses of IL-2 will be~     administered, at approximately 2 month intervals. Clinical, laboratory, immunologic, and~     viral parameters will be closely monitored during this time for evidence of toxicity and~     preliminary evidence of efficacy.~   "
274735|NCT00001281|"~     This study will examine the effects of HIV infection on substances produced by immune cells~     that increase or decrease HIV infection.~      HIV-infected patients and healthy normal volunteers may be eligible for this study.~     Participants will be required to have a yearly medical evaluation, including blood tests for~     cell counts and chemistries, a blood or urine pregnancy test for women, and other laboratory~     tests as medically indicated or for research purposes.~      Participants will donate blood or reproductive fluids, or both. From 20 to 150 cc (4 to 30~     teaspoonfuls) of blood will be drawn from the arm using a small needle. Participants may be~     asked to provide blood samples on more than one occasion over the course of the study. No~     more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period. Males~     will be given a private room for semen donation; fluid from females will be collected with a~     cotton swab after speculum insertion. Participants may also be asked to have a buccal swab.~     For this procedure, the inside of the cheek is gently scraped with a blunt-ended stick or~     brush to obtain cells (buccal mucosal cells). The tissues will be used for a variety of~     studies on the effects of HIV infection on factors that increase or decrease HIV infection.~      Some of the tissues collected for this study may also be used for the following tests:~        -  Hepatitis screening Blood may be screened for different types of viral liver infections,~          such as hepatitis A, B, C, D, E, or G.~        -  Genetic testing DNA from blood or cheek cells may be examined for mutations or deletions~          that affect chemokines, cytokines and a family of enzymes called caspases. Chemokines~          and cytokines are important mediators of the immune response. Alterations in the genes~          for some of these substances influence HIV infection. Caspases regulate the process of~          cell death, known as apoptosis. Caspase gene variations may determine the rate of cell~          death in HIV-infected persons, and therefore, the rate of HIV progression. Patients with~          abnormalities of any of these genes may be invited to join other studies of the role of~          genetic defects in HIV infection.~        -  HLA testing Blood may be tested for HLA type a genetic marker of the immune system.~          These tests may be used to try to identify factors associated with the rate of~          progression of HIV disease or related conditions. Determining HLA type is necessary to~          be able to perform certain research studies. Some HLA types have been associated with an~          increased risk of certain diseases like arthritis and other rheumatologic problems.~   "
274736|NCT00001277|"~     Patients whose parathyroid activity is elevated above normal are referred to as having~     hyperparathyroidism. This study will help researchers better understand the causes of~     hyperthyroidism and to evaluate and improve methods for diagnosis and treatment.~      In this study, patients diagnosed with or suspected of having hyperparathyroidism will be~     selected to participate. In addition, patients with related conditions such as parathyroid~     tumors, will also be selected.~      Subjects will be asked to provide blood and urine for testing to confirm their condition.~     They will then be surgically treated by removal of the parathyroid gland(s)~     (parathyroidectomy).~      Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact~     location of the tumor as well as the tumor's activity. The tests may include; ultrasounds,~     nuclear scanning, CT scans, MRI, and specialized blood testing.~      Sometimes parathyroidectomy leads to hypoparathyroidism. Options for treating the patients~     after the surgical procedure will also be addressed. Calcium and Vitamin D supplements are~     typically the mainstay of post parathyroidectomy therapy. Other potential treatments include~     transplanting the parathyroid gland(s) to other areas of the body.~   "
274737|NCT00001276|"~     Hypoglycemia is the term used to refer to lower than normal levels of blood sugar. This study~     will continue to research the causes of hypoglycemia.~      Patients involved in the study will be admitted to the Clinical Center of the National~     Institutes of Health and undergo tests for evaluating blood sugar. Patients will be required~     to refrain from eating for a set period of time and will undergo blood tests for insulin~     levels and several other specific diagnostic tests related to insulin secretion. The patients~     will be under supervision and will be provided with appropriate medical and surgical~     attention as needed....~   "
274738|NCT00001275|"~     No proven therapy to restore ovarian function and fertility is available to patients with~     karyotypically normal spontaneous premature ovarian failure. We know that one-half of these~     patients have primordial follicles remaining in the ovary, and these follicles can function~     intermittently. This is a diagnostic omnibus protocol that permits baseline clinical~     evaluation of patients with prematurem ovarian failure. The findings will determine patients'~     suitability for specifically focused therapeutic research protocols.~   "
274739|NCT00001266|"~     One current hypothesis as to what limits duration of initial hormone response is the rapid~     emergence of hormone resistant prostate carcinoma cells. Suramin has shown effectiveness as a~     treatment for hormonally refractory prostate carcinoma. Survival was less in patients with~     high rather than low circulating androgen levels. Thus, suramin might slow the emergence of~     hormone refractory tumor cells while combined androgen ablation may maximize the~     effectiveness of suramin. In this trial, we will pilot this concept.~   "
274740|NCT00001265|"~     This study of inflammatory muscle diseases-polymyositis and dermatomyositis and related~     disorders-will examine what causes these diseases and describe the clinical features (signs~     and symptoms) associated with them. Inflammation and degeneration of skeletal muscles in~     these disorders leads to weakness and muscle wasting. The skin, lungs and other organs may~     also be involved.~      Patients 16 years of age and older with polymyositis, dermatomyositis, or a related disorder~     may be eligible for this study. Participants will undergo a complete history and physical~     examination, including routine blood and urine tests. Additional procedures for diagnosis,~     treatment or research may include:~        1. Blood sample for genetic studies.~        2. Muscle biopsy-removal of a tissue sample for microscopic examination. Under local~          anesthetic, a 1/2- to 1-inch long incision is made in the thigh or upper arm, and a~          small piece of muscle is removed.~        3. Electromyography-measurement of the electrical activity of a muscle. A needle is~          inserted through the skin into a muscle to record its electrical activity.~        4. Magnetic resonance imaging-visualization of organs or tissues, using a magnetic field~          and radio waves. The patient lies on a table inside a narrow cylinder (the MRI scanner)~          with a strong magnetic field for the scanning.~        5. Manual muscle strength testing by a physiotherapist.~        6. Swallowing studies using ultrasound (imaging using sound waves) and X-rays (barium~          swallow) to evaluate swallowing and speaking abilities.~        7. Questionnaires on swallowing ability and ability to perform daily living activities~        8. Pulmonary function tests-measurement of movement of air in and out of the lungs. The~          patient breathes into a machine to evaluate lung function.~        9. Chest X-rays to evaluate lung function.~       10. Electrocardiogram and, if necessary, Holter monitoring (measurement of the electrical~          activity of the heart) and echocardiogram (ultrasound imaging of the heart) to evaluate~          heart function.~       11. Apheresis-collection of white blood cells for research. Whole blood is collected through~          a needle placed in an arm vein. The blood circulates through a machine that separates it~          into its components. The white cells are removed and the rest of the blood is returned~          to the body through the same needle or through a second one placed in the other arm.~       12. MR guided muscle biopsy-measurement of glycogen in muscle tissue using magnetic~          resonance imaging. Certain patients may undergo this experimental procedure to compare~          MRI findings with those of muscle biopsy. The affected muscles are identified using MRI~          and the biopsy incision is made. MRI is then used to guide the biopsy needle to the~          muscle and a small piece is removed.~      Patients who are eligible for experimental treatment studies will be offered the opportunity~     to join them. Others will be advised of treatment recommendations.~   "
274741|NCT00001262|"~     Menkes Disease is a genetic disorder affecting the metabolism of copper. Patient with this~     disease are both physically and mentally retarded. Menkes disease is usually first detected~     in the first 2-3 months of life. Infant males born with the disease fail to thrive,~     experience hypothermia, have delayed development, and experience seizures. These infants also~     have characteristic physical features such as changes of their hair and face. Females may~     also have changes in hair and skin color, but rarely have significant medical problems.~      Appropriate treatment of Menkes Disease requires that the disease be diagnosed early and~     treatment started before irreversible brain damage occurs. The aim of treatment is to bypass~     the normal route of absorption of copper through the gastrointestinal tract. Copper must then~     be delivered to brain cells and be available for use by enzymes.~      Copper histidine is a copper replacement that can be injected directly into the body to avoid~     absorption through the gastrointestinal tract. However, studies have shown the genetic~     abnormalities causing Menkes disease cannot simply be corrected by copper replacement~     injections.~      The genetic abnormality causing Menkes disease can vary in its severity. Patients with a~     genetic abnormality that may still permit some production of the enzymes required to process~     copper may receive benefit from early treatment with copper replacement. However, patients~     with severe abnormalities of the genes responsible for copper metabolism may receive no~     benefit from copper replacement.~      The purpose of this study is to continue to evaluate the effects of early copper histidine in~     Menkes disease patients and to correlate specific molecular defects with responses to~     treatment.~   "
274801|NCT00001177|"~     The purpose of this study is to identify and describe the symptoms of premenstrual syndrome~     (PMS).~      Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and~     evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual~     Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1)~     identifying the endocrine changes that may be responsible for changes in mood and behavior~     during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3)~     identifying genetic factors in women with and without PMS. Women with recurrent brief~     depression will also be recruited to serve as a comparison group.~   "
274742|NCT00001261|"~     Inflammatory myopathies are a group of muscle diseases characterized by muscle weakness, high~     levels of muscle enzymes in the blood, and inflammation of the tissue surrounding muscle~     fibers (endomysium).~      The diseases making up the inflammatory myopathies are grouped into three subsets:~      I) Polymyositis (PM)~      II) Dermatomyositis (DM)~      III) Inclusion Body Myositis (IBM)~      Inflammatory myopathies are thought to be autoimmune processes and are treated with steroids~     and immunosuppressive drugs. However, many patients who initially respond to these treatments~     develop resistance to the therapy or experience side effects causing the treatments to be~     stopped.~      Researchers believe that intravenous immunoglobulin (IVIg) may provide patients with PM, DM,~     and IBM a safer and more effective alternative to standard therapies for the diseases. IVIg~     is a drug that has been used successfully to treat other immune-related diseases of the~     nervous system.~      The study will take 60 patients and divide them into two groups. Group one will receive 2~     injections of IVIg once a month for three months. Group two will receive 2 injections of~     placebo inactive injection of sterile water once a month for three months. Following the~     three months of treatment, group one will begin taking the placebo and group two will begin~     taking IVIg for an additional 3 months. The drug will be considered effective if patients~     receiving it experience a significant improvement (>15%) in muscle strength.~   "
274743|NCT00001260|"~     The purpose of this study is to collect and study the brain tissue of deceased individuals to~     learn more about the nervous system and mental disorders. Information gained from donated~     tissue may lead to better treatments and potential cures for nervous system and mental~     disorders.~      This study will ask relatives of deceased individuals to donate the brains of their deceased~     relatives to allow further study of neurological and psychiatric disorders. We do not accept~     prospective donations.~   "
274744|NCT00001259|"~     This study examines the effects of estrogen and progesterone on mood, the stress response,~     and brain function and behavior in women with premenstrual syndrome.~      Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to~     be an effective treatment for PMS. The current purpose of this study is to evaluate how low~     levels of estrogen and progesterone (that occur during treatment with leuprolide acetate)~     compare to menstrual cycle levels of estrogen and progesterone (given during individual~     months of hormone add-back) on a variety of physiologic measures (brain imaging, stress~     testing, etc.) in women with PMS.~      PMS is a condition characterized by changes in mood and behavior that occur during the second~     phase of the normal menstrual cycle (luteal phase). This study will investigate possible~     hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate~     and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The~     results of these hormonal studies will be compared between women with PMS and healthy~     volunteers without PMS (see also protocol 92-M-0174).~      At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy~     tests will be performed. Cognitive functioning and stress response will be evaluated during~     the study along with brain imaging and genetic studies.~   "
274745|NCT00001258|"~     The purpose of this study is to use brain imaging technology to investigate the role of the~     frontal lobe of the brain in the thinking of individuals with schizophrenia and other~     neuropsychiatric disorders and healthy volunteers.~      Participants in this study will undergo a positron emission tomography (PET) scan of the~     brain while performing neuropsychological tests. Some of the tests involve cognitive~     operations that depend upon the frontal cortex. Interactions between frontal lobe activation,~     cognitive behavior, and neuropharmacology will be assessed by measuring regional cerebral~     blood flow (rCBF) during treatment with drugs that may affect frontal lobe physiology.~   "
274746|NCT00001257|"~     This study will investigate the inflammatory response. People with abnormal regulation of~     inflammation and immune defects often have an exaggerated or depressed inflammatory response~     that results in poor healing of recurrent infections. This study will measure and compare~     amounts of inflammatory mediators (chemicals involved in the inflammatory response) in~     healthy normal volunteers and in patients with abnormal immune responses.~      Healthy normal volunteers and patients with host defense defects or excessive inflammation,~     as in vasculitis syndromes, may be eligible for this study. Patients must be between 6 and 65~     years of age.~      Participants will have eight small blisters raised on the forearm using a gentle suction~     device. The top of the blisters will be removed with scissors and a plastic template will be~     placed over the blisters. The wells of the template will be filled with a salt solution or a~     mixture of the subject s serum (fluid part of the blood without cells) and a salt solution.~     Some blisters may be covered with coverslips a small round piece of very thin sterilized~     glass before adding the fluid. Blister fluid will be removed from the wells at 3, 5, 8, and~     24 hours with a syringe and analyzed for inflammatory mediators. A scab will form over the~     blisters and fall off in about 2 weeks.~      Participants will have about 4 tablespoons of blood drawn in order to compare the~     inflammatory mediators in the blood with those in the blister fluid.~   "
274747|NCT00001256|"~     This study will evaluate the safety and effectiveness of prednisone and methotrexate in~     treating severe Wegener's granulomatosis and other systemic vasculitides. These diseases~     involve inflammation of blood vessels (vasculitis) that may affect the brain, nerves, eyes,~     sinuses, lungs, kidneys, intestinal tract, skin, joints, heart and other sites. Current~     treatment with prednisone and the anti-cancer drug cyclophosphamide is effective, but has~     significant side effects and a high rate of disease recurrence. In a small number of patients~     with vasculitis, prednisone and methotrexate, another anti-cancer drug, have led to marked~     improvement, with fewer side effects than are seen with cyclophosphamide. This study will~     evaluate this drug combination in a larger patient population.~      Patients 10 to 80 years of age with active Wegener's granulomatosis, polyarteritis nodosa,~     Churg-Strauss vasculitis, or microscopic polyangiitis overlap may be eligible for this 2 1/2~     to 3-year study. In addition, patients with glomerulonephritis (a type of kidney disease) and~     a positive blood test for C-ANCA (antibodies found in certain vasculitic kidney diseases) or~     inflammatory sinusitis or lung nodule or infiltrates in the absence of infection may also be~     enrolled.~      Participants will take prednisone daily, by mouth, and low-dose methotrexate weekly, by mouth~     or by injection either under the skin, into a muscle or into a vein. Patients who~     significantly improve with treatment will gradually reduce, and eventually stop, the~     prednisone. If the remission lasts, methotrexate will also be reduced and stopped after 2 1/2~     years. If active disease recurs, the original treatment program may be started again.~     Patients who never achieve complete remission with treatment but whose symptoms are well~     controlled and experience no serious side effects may choose to either continue low-dose~     methotrexate or stop therapy.~      Patients will be hospitalized 4 to 6 times a year, about 2 to 8 days each time, depending on~     their disease severity and response to illness. In addition, they will have the following~     tests and procedures:~        -  Medical history and physical examination (upon admission to the study and then every 1~          to 3 months).~        -  Blood tests for blood cell counts and for levels of enzymes that indicate liver damage~          (upon admission, then weekly, and finally, no less than monthly).~        -  Additional blood tests to measure blood chemistries and evaluate kidney function (upon~          admission and again when clinically indicated).~        -  Chest X-rays (upon admission and when clinically indicated).~        -  Computerized tomography (CT) and magnetic resonance imaging (as needed).~        -  Electrocardiogram (upon admission and then as clinically indicated).~        -  Lung function studies (upon admission and at least every 6 months or as clinically~          indicated).~        -  Ear, nose and throat evaluations (as clinically indicated).~        -  Liver biopsy, if blood tests to monitor liver function are persistently abnormal. This~          procedure is done in the hospital under sedation to induce relaxation and drowsiness.~          The skin over the liver (upper right abdomen) is numbed with a local anesthetic and a~          needle is passed rapidly in and out of the liver to collect a small tissue sample for~          microscopic examination.~   "
274748|NCT00001255|"~     This study will monitor the long-term effects of gene therapy in patients with severe~     combined immunodeficiency disease (SCID) due to a deficiency in an enzyme called adenosine~     deaminase (ADA). It will also follow the course of disease in children who are not receiving~     gene therapy, but may have received enzyme replacement therapy with the drug PEG-ADA.~      ADA is essential for the growth and proper functioning of infection-fighting white blood~     cells called T and B lymphocytes. Patients who lack this enzyme are, therefore, immune~     deficient and vulnerable to frequent infections. Injections of PEG-ADA may increase the~     number of immune cells and reduce infections, but this enzyme replacement therapy is not a~     definitive cure. In addition, patients may become resistant or allergic to the drug. Gene~     therapy, in which a normal ADA gene is inserted into the patient's cells, attempts to~     correcting the underlying cause of disease.~      Patients with SCID due to ADA deficiency may be eligible for this study. Patients may or may~     not have received enzyme replacement therapy or gene transfer therapy, or both. Participants~     will have follow-up visits at the National Institutes of Health in Bethesda, Maryland, at~     least once a year for a physical examination, blood tests, and possibly the following~     additional procedures to evaluate immune function:~        1. Bone marrow sampling - A small amount of marrow from the hip bone is drawn (aspirated)~          through a needle. The procedure can be done under local anesthesia or light sedation.~        2. Injection of small amounts of fluids into the arm to study if the patient's lymphocytes~          respond normally.~        3. Administration of vaccination shots.~        4. Collection of white blood cells through apheresis - Whole blood is collected through a~          needle placed in an arm vein. The blood circulates through a machine that separates it~          into its components. The white cells are then removed, and the red cells, platelets and~          plasma are returned to the body, either through the same needle used to draw the blood~          or through a second needle placed in the other arm.~        5. Blood drawings to obtain and study the patient's lymphocytes.~   "
275389|NCT00000263|"~     The purpose of this study is to determine the effects of combined alcohol and nitrous oxide~     intake on mood, psychomotor performance, and the pain response in healthy volunteers.~   "
274750|NCT00001253|"~     The development of the brain in females is a result of a combination of factors. During~     puberty estrogen plays a role in influencing brain development. Cultural and environmental~     factors also play a role in the development of the brain.~      Female patients with Turner syndrome lack the ability to produce estrogen due to undeveloped~     ovaries. Therefore, Turner syndrome is the perfect condition to study how estrogen (or the~     lack of estrogen) influences a person's behavior and thinking.~      This study will compare cognitive differences (visual motor skills, visual-spatial,~     psychosocial behavior, and visual memory) of patients with Turner syndrome to normal patient~     controls. Researchers will use the Weschler Intelligence Scale for Children-Revised (WISC-R)~     along with other tests and scales to measure different aspects of the patient's cognitive~     ability. In addition the study will review patients with Turner syndrome who previously~     received estrogen replacement as infants and children in a related research study.~      Researchers hope to demonstrate that estrogen replacement will improve cognition and behavior~     in girls with Turner syndrome.~   "
274751|NCT00001252|"~     This study will collect information on the different ways people control limb and body~     movements. This information will be used to develop a database on normal movements and~     adaptive movements of people who have diseases that affect the way they move. The database~     will serve as a tool to improve diagnosis and treatment of patients with movement-related~     problems.~      Volunteers over the age of 4 who have normal movement patterns or who have developed~     different ways to perform movement tasks may be eligible for this study. A physical therapist~     will screen candidates to determine their strength, flexibility and range of motion of~     joints.~      Participants will be asked to perform movements such as walking, walking up or down stairs,~     standing quietly or reaching for an object. For the test, the arms and legs are wrapped with~     a soft, rubber-like material to which small plastic reflective balls are attached. A piece of~     firm material called a shell may be attached to the rubber sleeves or other areas of the~     body. Then the volunteer performs the specified task several times while special cameras~     record the movement. The cameras only record the positions of the reflective balls during~     movement, not the person s face or body. Electrical activity in the muscles also may be~     measured, using small metal electrodes attached to the surface of the skin with an adhesive~     bandage.~   "
274752|NCT00001251|"~     The purpose of this study is to determine efficacy of intrathecal mafosfamide, a preactivated~     derivative of cyclophosphamide against meningeal malignancies refractory to conventional~     therapy (radiation therapy and chemotherapy). The maximally tolerated dose for intrathecal~     mafosfamide will be established in a limited dosage escalation schedule. The CSF~     pharmacokinetics of intrathecal mafosfamide will also be studied.~      Mafosfamide will be administered intrathecally on a bi-weekly basis for four weeks, followed~     by twice monthly administration for four months and then monthly IT administration. A minimum~     of 9 patients will be studied in each disease category (leukemias, lymphomas, and other~     malignancies refractory to conventional therapy).~   "
274753|NCT00001250|"~     Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of~     the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy.~     Histologic confirmation of invasive carcinoma is required. Patients are prospectively~     randomized to receive five 21-day cycles of dose-intense (5-fluorouracil, adriamycin,~     leucovorin, cytoxan, granuloctye-colony stimulating factor [FLAC/G-CSF]) chemotherapy either~     before (preoperative) or after (postoperative) local therapy. Chemotherapy is given as an~     outpatient. For patients receiving preoperative chemotherapy, local therapy (modified radical~     mastectomy, or breast segmentectomy/axillary dissection/breast radiotherapy according to~     patient preference) is performed 3-4 weeks after last chemotherapy. For patients receiving~     postoperative chemotherapy, chemotherapy will begin 2-3 weeks after local therapy. Immediate~     reconstruction for mastectomy is acceptable. Upon completion of local therapy and~     chemotherapy in either treatment group, all estrogen receptor positive patients receive~     tamoxifen for 5 years. Follow-up consists of history and physical examination each 3 months~     for first 3 years, each six months for years 4 and 5, and yearly thereafter. Mammogram, bone~     scan, chest x-ray and blood work are performed yearly.~   "
274754|NCT00001248|"~     Studies performed under 89-N-0045 are designed to examine the natural history of multiple~     sclerosis (MS) using MRI and immunological measures. In addition to studying the natural~     history of untreated patients, the natural history of patients receiving approved~     disease-modifying therapies of MS will be examined. In both cohorts of patients levels of~     disease activity on MRI will be compared with immunological characteristics in order to help~     identify disease mechanism. Patients with either definite MS (based either on clinical or~     combined clinical and MRI criteria) or with an initial presentation of neurological~     dysfunction consistent with MS will be studied longitudinally by MRI. Disease activity on MRI~     will be assessed using several MRI measures of disease activity including the number of~     contrast enhancing lesions, the overall burden of disease, brain atrophy and measures to~     assess axonal damage. Patients will be assessed clinically and correlations between~     immunological and genetic factors and disease activity as seen clinically or by MRI will be~     studied.~      A second cohort of patients starting the use of approved therapy will also be examined.~     Patients referred to NIH prior to beginning approved therapy will be assessed with a series~     of three monthly MRIs to determine the level of pretreatment disease activity. After~     beginning approved therapy under the direction of their private physician, patients will be~     followed similarly to the natural history cohort. Immunological and genetic findings will be~     accessed before and during therapy in order to help establish the mechanisms of action of the~     therapies and to identify mechanisms accounting for either a response or lack of response to~     therapy. Part of the collected samples willl be cryopreserved to provide respository for~     further studies focusing on detection of biomarkers indicative of disease state, disease~     stage or repsonse to therapies.~      Additionally, a cohort of normal volunteers will be studied. The studies in the normal~     volunteers will be used to establish the most appropriate imaging sequences for studying~     normal white matter in MS patients using magnetization transfer (MT) imaging sequences for~     studying normal white matter in MS patients using magnetization transfer (MT) imaging and to~     provide normative immunological measures.~   "
274755|NCT00001247|"~     The purpose of this study is to understand the biologic basis of schizophrenia and to~     determine which symptoms are related to the illness itself and which are related to~     medications used to treat the illness.~      Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor~     and whose pathophysiology remains obscure. Brain imaging technologies such s positron~     emission tomography (PET), functional magnetic resonance imaging (fMRI), and magnetic~     resonance imaging (MRI) offer opportunities to study the pathophysiology of psychotic~     disorders by evaluating brain function. However, the use of anti-psychotic drugs may~     interfere with the results of such studies. In this study, psychotropic medication will be~     discontinued in patients for a short period of time to distinguish the effects of the illness~     on the brain without the interference of the medication's effects on the brain. Given that~     there is a risk that the patient's symptoms will increase, they are asked to stay on an~     inpatient unit where the NIMH clinical staff is available to help them 24 hours a day.~      This study will be conducted in three phases. In Phase 1, participants will be admitted to~     the Clinical Center while continuing to take their medication and will undergo diagnostic~     interviews, physical and laboratory assessments, physiological monitoring, and~     neuropsychological testing. Behavioral ratings will also be performed and blood and urine~     samples will be collected. During Phase 2, participants will continue taking medications in a~     blinded fashion for 8 to 12 weeks. The active medications will be replaced with a placebo (an~     inactive pill) part of that time. PET, fMRI, and MRI scans will be used to monitor how the~     continuation or lack of medication affects the brain. Psychological tests will also be given~     to measure changes in cognition. In Phase 3, participants will have the opportunity for~     clinical stabilization.~   "
274756|NCT00001246|"~     Magnetic Resonance Imaging (MRI) unlike X-rays and CT-scans does not use radiation to create~     a picture. MRI use as the name implies, magnetism to create pictures with excellent~     anatomical resolution. Functional MRIs are diagnostic tests that allow doctors to not only~     view anatomy, but physiology and function. It is for these reasons that MRIs are excellent~     methods for studying the brain.~      In this study, researchers will use MRI to assess brain anatomy and function in X and Y~     chromosome variation, healthy volunteers, and patients with a variety of childhood onset~     psychiatric disorders. The disorders include attention deficit disorder, autism, congenital~     adrenal hyperplasia, childhood-onset schizophrenia, dyslexia, obsessive compulsive disorder,~     Sydenham's chorea, and Tourette's syndrome.~      Results of the MRIs showing the anatomy of the brain and brain function will be compared~     across age, sex (gender), and diagnostic groups. Correlations between brain and behavioral~     measures will be examined for normal and clinical populations.~   "
274757|NCT00001245|"~     This study will explore faster and easier ways to detect infection with the intestinal~     parasite Strongyloides stercoralis and learn more about the conditions under which it causes~     serious disease. Ordinarily, the Strongyloides helminth (type of intestinal worm) causes only~     few, if any, symptoms, but in people with weakened immunity it may be very serious, and even~     deadly.~      People between 5 and 80 years of age with known or suspected S. stercoralis infection, or~     infection with another helminth, such as filariasis, that might cause a cross-reaction with~     S. stercoralis may be eligible for this study.~      Participants found to be infected with S. stercoralis will be treated with ivermectin,~     thiabendazole, or albendazole. In addition, they will undergo the following tests and~     procedures:~        -  Blood tests and stool samples: Samples will be collected before and after treatment to~          check general health status and immune function, and to look for parasites in stool. Up~          to 50 milliliters (10 teaspoons) of blood will be drawn in adults and up to 25 ml (5~          teaspoons) in children.~        -  Skin tests: A test similar to those used for tuberculosis and allergies will be~          conducted to determine if there is sensitization to products of the parasite. Such a~          test might be used as a rapid method to diagnose the infection. About three drops of~          several different antigens (proteins) are injected into the skin of the arm. After 15 to~          20 minutes, the area is checked to see if a red spot has formed and, if so, the spot is~          measured.~   "
274758|NCT00001244|"~     This study will explore the cause of immunodeficiency in common variable immunodeficiency~     (CVI) and other related immunodeficiency syndromes IgA deficiency, hyper IgM syndrome,~     thymoma and agammaglobulinemia, hypogammaglobulinemia associated with Epstein-Barr infection,~     and others to better focus on how to correct the underlying defect.~      Patients with CVI and their family members may participate in this study. Family members must~     be between the ages of 18 and 85, in good health and weigh at least 110 pounds.~      Patients will receive standard medical care for their illness. Procedures may include a~     medical history and physical examination, routine blood tests, stool examination for~     infectious agents, lung function tests, chest and sinus X-rays. Treatment may include~     administration of immune serum globulin, antibiotics for infections, and anti-inflammatory~     drugs, if needed. In addition, patients may undergo the following:~        -  Lymphapheresis: This procedure is done to collect large numbers of white blood cells~          (lymphocytes). Blood is collected through a needle in an arm vein, similar to donating~          blood. The blood is separated it into its components by centrifugation (spinning), the~          white cells are removed, and the rest of the blood (red cells, plasma and platelets) is~          returned to the body, either through the same needle or through another needle in the~          other arm.~        -  Blood draw: Blood may be drawn through a needle in an arm vein (venipuncture). No more~          than 450 milliliters (15 ounces) of blood will be collected over a 6-week period from~          adults, and no more than 7 ml (1 1/2 teaspoons) per kilogram (2.2 pounds) of body weight~          in children over the same time period.~        -  Lymph node biopsies: Lymph node biopsies will be done only if required for diagnostic~          purposes. Some of the biopsy tissue may be kept for research. Up to two lymph nodes may~          be removed during each procedure. For the procedure, a painkiller is injected into and~          beneath the skin in the biopsy area, and the node is removed surgically. The incision is~          closed using dissolving sutures (stitches) that do not require removal. The biopsy takes~          about 30 minutes. Patients will be hospitalized at least overnight for observation.~        -  Intestinal biopsies: Endoscopy and gastrointestinal biopsy will be done only if there is~          evidence of malabsorption. Some of the biopsy tissue may be kept for research. Patients~          are pre-medicated to allay anxiety, but are fully conscious during the procedure. A~          flexible tube is inserted into the stomach or small intestine through the mouth. The~          tube allows the doctor to see the intestinal mucosa and to project the image onto a TV~          screen. At various places in the mucosal surface, small pieces of tissue are plucked out~          using a small space at the tip of the endoscope. The procedure takes 30 to 60 minutes.~      Some of the blood collected may be used for genetic tests. Some blood and tissue samples may~     be stored for future research labeled with a code, such as a number, that only the study team~     can link to the patient.~      Participating family members will provide a medical history, and their pulse, blood pressure~     and temperature will be taken. They will have 10 to 120 ml (1/3 to 4 ounces) of blood drawn~     from a vein in the arm. Blood samples may be taken on repeated occasions as long as the~     relative remains in the study. The blood will be used for research that may involve~     development of diagnostic tests for CVI, evaluation of the structure and function of normal~     blood cells for comparison with those of patients with CVI, and studies to try to determine~     possible genetic factors involved in susceptibility to CVI.~   "
274759|NCT00001243|"~     This study will examine the effects of HIV on bone marrow cells. Various types of cells from~     bone marrow will be studied to learn which cells become infected with HIV, what changes occur~     in the number of or growth patterns of the cells, what kinds of proteins the cells make in~     the presence or absence of HIV and whether the cells can function normally.~      HIV-infected and non-infected individuals 18 years of age and older may participate in this~     study.~      Participants will undergo the following procedures:~        -  Blood draw: Blood will be drawn through a needle from a hand or arm vein. About 150~          milliliters (10 tablespoons) will be collected each time. No more than 450 ml (30~          tablespoons) will be taken over a 6-week period.~        -  Bone marrow aspirate: Bone marrow will be drawn from the hipbone. For this procedure, a~          local anesthetic is injected in the skin over the hipbone. A small needle is put about~          1/2-inch through the shell of the bone and about 3 to 4 teaspoons of marrow are drawn~          from the cavity into a syringe.~      White cells from marrow of uninfected individuals may be infected with HIV in the laboratory~     and grown over time for study. Alternatively, uninfected cells may be used as controls to~     compare with cells from HIV-infected individuals.~      White cells from marrow of HIV-infected individuals will be grown in the laboratory and~     studied in comparison with cells from uninfected individuals. Or, bone marrow cells may be~     injected into immune-deficient mice to try to develop an animal model for HIV infection.~     White blood cells will also be studied in the laboratory to learn how the immune system~     responds to HIV infection.~   "
274760|NCT00001242|"~     Patients with confirmed or suspected conditions with a resistance to vitamin D or parathyroid~     hormone (PTH) will be admitted for diagnosis and treatment, and inclusion in other studies~     pertaining to similar conditions.~      This study will provide information about problems relating to calcium in the blood, urine,~     and bones. Patients in this study will undergo a general evaluation / check-up to give~     researchers an idea of each person's condition or disease. Patients will receive treatment~     based on their diagnosis and asked to provide specimen samples for further research studies.~   "
274761|NCT00001241|"~     In patients with Zollinger-Ellison Syndrome the level of gastric acid is elevated. This~     increased level of gastric acid is what causes the symptoms of the disease. Certain types of~     medication can control the secretion of gastric acid. In this study there are details on how~     drugs known as antihistamines (H2 receptor antagonists) can control the levels of gastric~     acid secretion.~      The study describes; which patients are candidates for this research, what to do prior to~     initiating treatment, and the appropriate dose of antihistamine to be given.~      Initial doses of the medication will be given intravenously (injected through a vein) and~     later doses will be administered orally (by mouth).~      By following the procedure, researchers will be able to determine if there is a more~     effective route of drug administration, as well as the effectiveness of antihistamines in~     patients treated surgically for Zollinger-Ellison pancreatic tumors with mildly elevated~     gastric acid levels.~   "
274762|NCT00001240|"~     This study is used by the Digestive Diseases Branch to evaluate patients with suspected~     abnormalities in the secretion of gastric acid. The level of gastric acid is measured by~     analyzing the gastric juices of each individual patient. The gastric acid sample is obtained~     by a procedure known as nasogastric suctioning, where a thin plastic tube is passed from the~     nose to the stomach.~      Depending on the patient's present condition further diagnostic testing may be required to~     achieve a diagnosis.~   "
274763|NCT00001238|"~     We will investigate the clinical manifestations and molecular genetic defects of heritable~     urologic malignant disorders. Families with urologic malignancy with known or suspected~     genetic basis will be enrolled. Affected individuals or individuals suspected of having a~     germline urologic malignant disorder will undergo periodic clinical assessment and genetic~     analyses for the purpose of: 1) definition and characterization of phenotype, 2)~     determination of the natural history of the disorder, and 3) genotype/phenotype correlation.~     Genetic linkage studies may be performed in situations in which the genetic basis of the~     disorder has not been elucidated.~   "
274764|NCT00001235|"~     Alzheimer's disease is a condition marked by the deterioration of mental function. The~     disease usually begins in late middle life and results in death in 5 to 10 years. Patients~     with Alzheimer's disease typically suffer from memory loss, confusion, and disorientation.~     The condition has become a major medical and social problem in the United States because of~     the increasing number of people living beyond the age of 65. The actual cause of Alzheimer's~     disease is unknown.~      Researchers believe that Alzheimer's disease, or at least a portion of cases, may be an~     inherited condition. As a result, many new techniques have been developed to study the~     genetic causes of Alzheimer's disease and other neurological disorders. Many of these genetic~     techniques require blood samples and a family pedigree. A pedigree is a chart, similar to a~     family tree, that shows a patient's family history.~      The purpose of this study is to collect family and psychosocial information, blood, and~     biopsy samples from patients with neurological diseases, their families, and normal~     volunteers. This information gathered will be used to learn more about diseases that affect~     the brain.~   "
274765|NCT00001234|"~     Gaucher's disease is a lysosomal storage disease resulting from glycocerebroside~     GLUCOCEREBROSIDE (1) accumulation in macrophages due to a genetic deficiency of the enzyme~     glucocerebrosidase. It may occur in patients of all ages. The most severe form, Type 2~     Gaucher's Disease occurs in infants who die in the first years of life (with rapidly~     progressive neurologic deterioration). The condition is passed from generation to generation~     through autosomal recessive inheritance.~      Fabry's disease isa genetic disorder (X-linked recessive) due to the absence of the enzyme~     a-galactosidase A. The disease is characterized by abnormal collections of glycolipids in~     cells (histiocytes) within blood vessel walls, tumors on the thighs, buttocks, and~     genitalia(2) decreased sweating, tingling sensations in the extremities, and cataracts.~     Patients with Fabry's disease die from complications of the kidney, heart, or brain.~      Both conditions are caused by the absence of specific enzymes (3). Patients with these~     conditions are missing (3) or have defective genes needed for the normal production of these~     enzymes. Studies on the blood-forming cells in bone marrow have lead to gene therapies using~     retroviruses as vehicles to carry and insert working genes into abnormal or diseased cells.~      This study is designed to measure the safety and effectiveness of transferring working copies~     of genes responsible for making missing enzymes into the cells of patients with Gaucher's or~     Fabry disease.~   "
274766|NCT00001231|"~     The purpose of this study is to investigate mood and behavior changes in the time period~     surrounding and including menopause. This is an observational study; volunteers who~     participate will not receive any new or experimental therapies.~      Controversy exists regarding the relationship between estrogen and progesterone (gonadal~     steroid) changes and midlife-onset depression. This study will examine the role of gonadal~     steroids in perimenopausal mood and behavioral disorders.~      Perimenopausal women with depression symptoms and a control group of healthy perimenopausal~     volunteers will be compared to identify correlates of the occurrence of depression.~     Participants with depressive symptoms may also participate in companion studies that will~     test the antidepressant efficacy of phytoestrogens and selective estrogen receptor modulators~     (SERMS).~      A group of younger pre-perimenopausal women with normal menstrual cycle functioning will be~     followed through menopause in an effort to confirm the association of depression onset with~     changes in reproductive endocrine functioning.~   "
274767|NCT00001230|"~     This study will evaluate and treat patients with filarial infections to explore in depth the~     immunology of the disease, including susceptibility to infection, disease development, and~     response to treatment. Filarial infections are caused by parasitic worms. The immature worm~     (larva) is transmitted to a person through a mosquito bite and grows in the human body to 2~     to 4 inches in length. Although many of these infections do not produce symptoms, especially~     in the early stages of infection, others can have serious consequences, including swelling of~     the limbs or genitalia, allergic-lung problems, skin rash, eye inflammation that can lead to~     blindness, and heart disease. This protocol does not involve any experimental diagnostic~     procedures or treatments, and will use only procedures employed in the standard practice of~     medicine.~      Persons between 3 and 100 years of age diagnosed with or suspected of infection with~     Wuchereria bancrofti, Bugia malayi, Onchocerca volvulus, Loa loa, or other parasitic worms~     may be eligible for this study.~      Participants will have routine tests to determine the specific type of filarial infection.~     These may include special tests of the lungs, skin or heart, depending on the type of~     parasite suspected. Patients with skin reactions may have a punch biopsy to examine a small~     piece of affected skin. For this procedure, an area of skin is numbed with an anesthetic and~     a small circular area, about 1/3-inch in diameter and 1/2-inch thick, is removed using a~     sharp cookie cutter-type instrument. Some patients may require bronchoalveolar lavage. For~     this procedure, the mouth and throat are numbed with lidocaine jelly and spray and, if~     needed, a sedative is given for comfort. A small plastic tube is placed in a vein to give~     medications. A pencil-thin tube is then passed through the nose or mouth into the lung~     airways to examine the airways. Salt water is injected through the bronchoscope into the air~     passage, acting as a rinse. A sample of the fluid is then withdrawn and examined for~     infection, inflammatory cells and inflammatory chemicals. (Bronchoalveolar lavage is done~     only if medically necessary and only on patients 21 years or older.) Once the diagnosis is~     established, standard treatment will be instituted with either diethylcarbamazine or~     ivermectin, depending on the type of infection.~      Additional procedures for research purposes include:~        -  Extra blood draws to study immune cells and other immune substances. (This is the only~          research procedure that will be done in - More frequent and extensive follow-up~          evaluations than usual for routine care. They will include physical examination and~          blood studies.~        -  Urine collections at specified periods, possibly including 24-hour collections.~        -  Skin tests to examine the body s reaction to allergens-common environmental substances,~          such as cat dander or pollen-that cause an allergic reaction. The test is done in one of~          two ways: either the skin is lightly scratched and an allergen extract is placed over~          the just-broken skin, or a very fine needle is used to inject a small amount of allergen~          under the skin. In both methods, the site is monitored for swelling or hives in the next~          48 hours.~        -  Leukapheresis (only on patients 21 or older ) to collect quantities of white blood~          cells. Whole blood is collected through a needle in an arm vein, similar to donating~          blood. The blood circulates through a machine that separates it into its components, and~          the white cells are removed. The rest of the blood is returned to the body, either~          through the same needle or through another needle in the other arm.~   "
274768|NCT00001228|"~     This study will examine the safety and effectiveness of interferon-a and octreotide for the~     treatment of Zollinger-Ellison syndrome (gastrinoma) and advanced non-B islet cell cancer.~     Gastrinoma is a tumor produced by the pancreas that secretes the hormone gastrin, which in~     turn stimulates production of gastric juices that cause ulcers. Some of these tumors are~     malignant. Gastrinomas that have spread and cannot be surgically removed require drug~     treatment (chemotherapy). Current drug regimens, however, provide only temporary benefit and,~     in some cases, produce life-threatening side effects. In studies of patients with tumors~     similar to gastrinoma, the drugs octreotide and interferon-a, alone or in combination, showed~     some effect in stopping tumor growth and were better tolerated than chemotherapy. At least~     one-third of patients responded to treatment with either drug for at least 6 months; the two~     drugs given together may produce a better response than either one alone.~      Patients currently enrolled in an NIH study of Zollinger-Ellison syndrome whose gastrinoma~     has spread from the original site and cannot be surgically removed may be eligible for this~     study.~      Participants will be admitted to the NIH Clinical Center for blood and urine tests,~     electrocardiogram (EKG), chest X-ray and imaging studies (CT, ultrasound, MRI, octreoscan,~     and bone scan) before beginning treatment to evaluate the size and extent of tumors. Patients~     will then start interferon-a or octreotide, or both, given as injections under the skin.~     Treatment will continue for at least 6 months, unless side effects require stopping the drugs~     early. Patients whose tumors shrink or remain stable may continue treatment indefinitely.~     Those who do not respond to treatment will be taken off the study and offered standard~     chemotherapy.~      Patients will be admitted to the hospital for the first day or two of therapy to be monitored~     for side effects and to learn how to self-inject the drugs to continue therapy at home. Both~     drugs are given [Note: how often? once a day, twice a day, weekly?] (Octreotide is also~     available in long-acting form, and patients who prefer may be given this drug once a month by~     the doctor.)~      During the treatment period, patients will be seen by their personal physician every 2 weeks~     for the first month and once a month thereafter for a medical evaluation and check of adverse~     side effects of treatment. In addition, they will be admitted to the NIH Clinical Center once~     every 3 months for a medical evaluation and imaging studies, including CT, MRI, ultrasound,~     bone scan, and octreoscan, to assess the effect of treatment on tumor size.~   "
274769|NCT00001226|"~     Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the~     blood. This study is designed to improve understanding of normal, as well as abnormal,~     lipoprotein metabolism and the role it plays in the development of hardening of the arteries~     (atherosclerosis).~      Patients participating in this study will receive an intravenous (directly into the vein)~     injection of a small amount of specially prepared amino acids. The amino acids being injected~     are the same amino acids present in a normal diet. The amount of amino acid given will be~     less than the amount eaten in a protein-rich meal. The amino acids will be labeled with~     nonradioactive heavy isotopes which are also present in the environment n low amounts.~      Patients participating in the study will be required to have blood samples taken, and provide~     urine samples throughout the course of the study. In addition, patient will be required to~     follow a specially formulated diet. Patients will be weighed throughout the course of the~     study.~   "
274802|NCT00001176|"~     Some patients with high blood pressure can experience an increase of blood pressure by 10~     percent or more by taking in salt. These patients are referred to as having salt-sensitive~     (SS) hypertension.~      Previous studies conducted on patients with salt sensitive hypertension suggest that their~     portion of the nervous system responsible for maintaining normal blood pressure (autonomic~     nervous system) may respond differently to salt than patients with non-salt sensitive (NSS)~     hypertension.~      This study is designed to examine the response of the nervous system to high doses of salt in~     patients with salt-sensitive hypertension and patients with non-salt sensitive hypertension.~   "
274803|NCT00001174|"~     This study looks to identify genes that may affect a person's chances of developing bipolar~     disorder (BP) and related conditions.~   "
274770|NCT00001225|"~     Hypertrophic cardiomyopathy (HCM) is a genetically inherited heart disease. It causes~     thickening of heart muscle, especially the chamber responsible for pumping blood out of the~     heart, the left ventricle. Hypertrophic cardiomyopathy (HCM) is the most important cause of~     sudden death in apparently healthy young people.~      A genetic test called linkage analysis is used to locate genes causing inherited diseases~     like HCM. Linkage analysis requires large families to be evaluated clinically in order to~     identify the members with and without the disease.~      In this study researchers will collect samples of DNA from family members of patients with~     HCM. The diagnosis of the disease will be made by history and physical examination,~     electrocardiogram (12 lead ECG), and ultrasound of the heart (2-D echocardiogram). The~     ability of the researchers to locate the gene responsible for the disease improves with~     increases in the size of the family and members evaluated.~      In order to continue research on the genetic causes of heart disease, researchers intend on~     studying families with specific genetic mutations (beta-MHC) causing HCM. Researcher plan to~     also study families with HCM not linked to specific gene mutations (beta-MHC).~   "
274771|NCT00001224|"~     The purpose of this investigation is to better understand the inflammatory process that~     occurs in uveitis (eye inflammation) through study of eye tissues.~      Patients with uveitis sometimes develop cataracts (clouding of the lens of the eye) or~     clouding of the vitreous-the gel-like material behind the lens-that can impair eyesight.~     Those who require cataract surgery or vitrectomy are eligible for this study. Samples of eye~     tissue and fluid normally removed during standard surgical procedures for these conditions~     will be given to researchers instead of discarded, as is usually done.~      Before surgery, patients will undergo routine preoperative tests, including chest X-ray,~     electrocardiogram, blood tests and urinalysis. They will also have an eye examination and~     photographs taken of the retina. Other tests that may be performed include fluorescein~     angiography to evaluate the blood vessels of the retina; ultrasound to examine the back of~     the eye; and a gallium scan to evaluate inflammation.~      Immune cells in the blood and eye tissue will be compared and categorized by disease. The eye~     fluid will be examined for substances involved in the inflammatory process. These studies may~     provide information that will lead to improved methods of diagnosis and treatment.~   "
274772|NCT00001223|"~     Cystic fibrosis is a disease that affects many parts of the body, particularly the lungs and~     pancreas. The main purpose of this study is to further understand the natural history,~     clinical presentation, and genetics of cystic fibrosis.~      Patients with cystic fibrosis will be asked to participate in this study by undergoing~     standard medical tests and procedures. Patients will have a history taken and have a physical~     examination as well as blood tests, and a sweat test (a test for cystic fibrosis of the~     pancreas in which electrolytes are measured in collected sweat). Patients may also be asked~     to provide samples of urine, stool, and sputum for additional tests. More complicated~     procedures such as bronchoscopy or bronchoalveolar lavage may be required for diagnosis,~     treatment, or research purposes.~      Patients will receive appropriate treatment with antibiotics, pancreatic enzymes, vitamins,~     physiotherapy, and other agents. Medications may be given by mouth or injected into a vein.~      This study will provide patients with information on the prognosis of the disease as well as~     recommendations for management of cystic fibrosis. In addition this study will provide~     information to researchers which may be useful in other studies of cystic fibrosis.~   "
274773|NCT00001221|"~     Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes.~     Girls with Turner syndrome are very short as children and as adults. Although their growth~     hormone secretion is almost always normal, giving injections of growth hormone to Turner~     syndrome girls may increase their rate of growth. In addition, most girls with Turner~     syndrome do not have normal ovaries.~      In normal girls the ovaries begin producing small amounts of the female sex hormone, estrogen~     at about 11 - 12 years of age. As girls grow older the level of estrogen increases. Estrogen~     is responsible for the changes in girls known as feminization. During feminization the hips~     grow wider, the breasts develop, there is an increase in the rate of growth, and eventually~     girls experience their first menstrual period.~      This study was designed to evaluate the effect of low dose estrogen, growth hormone, and the~     combination of low dose estrogen and growth hormone on adult height in girls with Turner~     syndrome. Patients will be entered into the study from ages 5 to 12 and will be randomly~     placed into one of four groups.~        1. Group one will receive low dose estrogen~        2. Group two will receive growth hormone~        3. Group three will receive both low dose estrogen and growth hormone~        4. Group four will receive a placebo sugar pill~      Once started, the treatment will continue until the patients approach their adult height, and~     growth slows to less than 1/2 inch over the preceding year. This usually occurs by the age of~     15 or 16.~      Patients will be seen at the outpatient clinic every 6 months during the study and will~     receive a routine check-up with blood and urine tests, and hand/wrist X-rays to determine~     bone age. On patient's yearly visits they will have the density of bone measured in their~     spine and forearm.~   "
274774|NCT00001220|"~     This study will identify clinical signs and symptoms critical for diagnosing swallowing~     disorders and will characterize swallowing problems in various patient populations, such as~     patients with Parkinson's disease, stroke, post-polio syndrome, multiple sclerosis and other~     conditions that cause swallowing abnormalities.~      Patients with swallowing difficulties who are enrolled in NIH neurology or speech pathology~     protocols may be eligible for this study. Participants will undergo the following procedures:~        1. Oral examination-A neurologist and speech pathologist examine the patient's swallowing~          function. The patient is interviewed about difficulties with food intake, chewing and~          swallowing during meals.~        2. Ultrasound examination-Ultrasound creates image of areas inside the body using sound~          waves. With the patient in a sitting position, a 3/4-inch transducer (device for~          transmitting and receiving sound waves) is placed under the chin to visualize tongue~          movements during swallowing.~        3. Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of~          flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the~          tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and~          videotaped. The barium is given in three consistencies-thin, medium and thick~          (pudding-like).~        4. Electromyography-A small plastic strip with wires attached is placed under the patient's~          chin. The patient then swallows 1/2 ounce of barium three times in a row, and the~          movement of the chin muscles during swallowing is displayed. Patients may also be asked~          to swallow 5/8 cup of barium twice; once with the head tilted upward and once with the~          head untilted.~      Depending on the test results, patients may be asked to return for follow-up study and~     monitoring.~   "
274870|NCT00000451|"~     This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in~     Alaska natives with alcohol dependence. The study will also examine whether a combination of~     naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone.~     Alaska Native individuals will be recruited into a 16 week outpatient study.~   "
274775|NCT00001219|"~     Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are diagnostic~     tests that allow researchers to look at different chemical properties of tissue. Magnetic~     resonance imaging and spectroscopy studies can be used to gather or evaluate information~     about various aspects of patient s bodies or to monitor changes in the biochemistry and~     physiology of patient s bodies.~      Unlike other diagnostic techniques (CT scan and PET scan) MRI and MRS do not use ionizing~     radiation. Some studies have shown that MRI is more effective at distinguishing normal parts~     of the anatomy from abnormal anatomy, especially in the brain. MRI has become the diagnostic~     test of choice for evaluating patient with multiple sclerosis.~      The purpose of this study is to evaluate normal volunteers and patients with a variety of~     diseases with magnetic resonance imaging. Researchers will attempt different magnetic~     resonance imaging methods and techniques as well as different levels of magnetic strength.~   "
274776|NCT00001215|"~     The purpose of this study is to identify genetic, biochemical, and clinical factors that are~     associated with disease severity in people with Gaucher disease and other lysosomal storage~     disorders.~      There is a vast spectrum of clinical manifestations in people with Gaucher disease as well as~     other lysosomal storage disorders. This study will evaluate patients with lysosomal disorders~     on an outpatient or inpatient basis in order to better characterize the clinical, genetic,~     and pathophysiological features of these disorders. Participants will be re-evaluated on an~     annual basis.~   "
274777|NCT00001214|"~     Aplastic anemia is a condition in which the cells normally found in blood are greatly~     decreased. The normal levels of white blood cells, red blood cells, and platelets are much~     lower in patients with aplastic anemia.~      Because of these low levels of blood cells, patients with aplastic anemia have a variety of~     immune system abnormalities. However, low levels of blood cells make it difficult to collect~     specialized white blood cells (mononuclear cells) for research studies.~      This study was designed to collect lymphocytes from patients with low levels of all blood~     cells (pancytopenia) for use in research. Patients participating in the study will undergo a~     special procedure known as lymphapheresis. During lymphapheresis blood is taken from the~     patient in a manner similar to blood donation. The white blood cells are selectively removed~     by spinning (centrifugation), and the remaining red blood cells and platelets are placed back~     (re-infused) into the donor s blood stream.~      Patients participating in this study will not benefit directly from it. However, cells~     collected in this study may increase scientific knowledge and improve understanding and~     treatment for diseases like aplastic anemia.~   "
274778|NCT00001213|"~     Cystinosis is an inherited disease that results in poor growth and kidney disease, among~     other things. The damage to the kidneys and other organs is thought to be due to accumulation~     of cystine inside the cells of various body tissues. This chemical also accumulates in the~     cornea-the covering of the eye over the pupil and iris. After 10 to 20 years, the corneas of~     some patients become so packed with crystals that the surfaces may become irregular,~     occasionally causing small, painful breaks.~      Patients enrolled in a NIH study on cystinosis are receiving the drug cysteamine. Taken by~     mouth, this drug reduces cystine in some tissues, but not in the cornea. This study began in~     1986 to test whether cysteamine eye drops could prevent or reduce corneal cystine crystals in~     these patients. The drops have been very effective in removing crystals and reducing pain in~     patients who take the medication as directed. Patients who do not take the medication as~     prescribed do not benefit.~      After the effectiveness of the drops was proven, the main purpose was modified to continue to~     evaluate the long-term safety and effectiveness of cysteamine eye drops for treating cystine~     crystals in the corneas of patients with cystinosis until the drops are approved by the Food~     and Drug Administration (FDA). When the New Drug Application (NDA) for the Sigma-Tau standard~     formulation is granted, this protocol will be terminated.~   "
274779|NCT00001212|"~     Studies have shown that up to 26% of patients with systemic lupus erythematoses nephritis may~     suffer from membranous lupus nephropathy. The disease is characterized by high levels of~     protein in the urine and may eventually lead to kidney failure.~      This study will evaluate the effectiveness and toxic effects of immunosuppressive drug~     therapy in patients with membranous lupus nephropathy over a 12 month period. The major goal~     of this therapy is to decrease protein losses and ultimately prevent kidney failure.~      Patients enrolled in the study will undergo a routine history and physical examination. In~     addition, several diagnostic tests will be conducted including; chest x-ray ECG, blood and~     urine laboratory tests.~      Patients will be divided and grouped according to the severity of their disease as shown by~     kidney function. Each group will then randomly be subcategorized by different treatment~     plans. Each treatment plan will made up of immunosuppressive medications including~     prednisone, cyclophosphamide, cyclosporin A, and combinations of these drugs. Patients will~     receive the medications as directed by the study.~      The study will last 12 months and require patients to be admitted for two to five days before~     the study begins and once the study is completed. Patients will be followed as outpatients~     throughout the 12 month study.~   "
274780|NCT00001208|"~     Botulism is a severe form of food poisoning caused by bacteria. This bacteria produces~     several toxins one of which is botulinum toxin A. This toxin causes the symptoms of food~     poisoning. Small amounts of botulinum toxin A have been used to treat speech disorders such~     as stuttering and problems with the muscles of the eyes.~      The study examines the effectiveness of botulinum toxin as treatment for a variety of~     movement disorders. The goals of the study are to refine the technique of treatment to~     provide the best results, to improve the understanding of how botulinum toxin works on~     movement disorders, and find other conditions that may be treatable with botulinum toxin.~      In addition, researchers also plan to study the possible use of botulinum toxin F alone and~     in combination with botulinum toxin A in patients who do not respond to botulinum A toxin~     treatment.<TAB>~   "
274781|NCT00001206|"~     The purpose of this study is to evaluate individuals with Attention Deficit/Hyperactivity~     Disorder (ADHD) to learn more about the genetics of the disease.~      This study is part of other ongoing studies of individuals with ADHD. The study participants~     have already undergone neurobiological measurements, particularly magnetic resonance imaging~     (MRI) of the brain, through other research studies. As a follow-up to these studies,~     participants will next undergo psychiatric interviews, neuropsychological tests, and another~     MRI. In addition to the clinical evaluation of the participants, further research will be~     conducted on the genetics of ADHD. These genetic studies will evaluate people with ADHD as~     well as their family members and a control group of healthy people....~   "
274782|NCT00001205|"~     The purpose of this study is to evaluate, treat and follow patients with cysticercosis, an~     infection with the larval form of the pork tapeworm, T. solium. When people ingest cysts of~     T. solium eggs, cysts develop in the muscles, brain and other organs. The cysts enlarge and~     cause inflammation, usually in the brain. Patients may develop seizures, headache, nausea,~     vomiting, inability to walk, poor vision due to enlargement of the brain, and increased~     pressure in the brain. Other neurological problems may develop depending on the location of~     the cysts. The drugs praziquantel and albendazole are used to treat cysticercosis, but it is~     not clear if these drugs are effective in all patients, such as those with calcified cysts or~     brain enlargement.~      Patients with suspected or confirmed cysticercosis may be eligible for this study.~     Participants will be hospitalized for 2 to 3 weeks and will take either praziquantel or~     albendazole by mouth for 2 weeks. They may receive a corticosteroid to lessen the side~     effects of the drug therapy. Patients will be evaluated with medically indicated tests and~     procedures that may include:~        -  Blood tests.~        -  X-rays of the head and long bones.~        -  Electroencephalogram recording of the electrical activity of the brain~        -  Lumbar puncture (spinal tap) examination of the cerebrospinal fluid that bathes the~          brain and spinal cord. For this procedure, a local anesthetic is given and a needle is~          inserted in the space between the bones (vertebrae) in the lower back. About 2~          tablespoons of fluid is collected through the needle.~        -  Eye examination.~        -  Magnetic resonance imaging (MRI) to examine the brain. MRI uses a strong magnetic field~          and radio waves instead of X-rays to demonstrate structural and chemical changes in the~          brain. During the scan, the patient lies on a table in a narrow cylinder (the scanner).~          He or she can speak with a staff member via an intercom system at all times during the~          procedure.~        -  Computed tomography (CT) to examine the brain. CT can be done from different angles and~          allows the doctor to view the brain in small sections in 3-dimensions. The patient lies~          on a table with the head positioned in the CT scanner.~      Some of the tests may be repeated on the last day of therapy and at 3 and 6 months or longer~     after therapy.~   "
274783|NCT00001204|"~     Homozygous familial hypercholesterolemia is a rare inherited disease of metabolism. It occurs~     in less than 1 in 1 million people within the United States. Patients with the disease are~     typically children and young adults who develop heart disease early in life. Children less~     than age 5 years with this disease have suffered heart attacks and death.~      The normal process that removes cholesterol particles from the blood stream does not work in~     patients with this disease. It causes cholesterol to build-up in the arteries and leads to~     hardening of the arteries (atherosclerosis).~      The goal of this study is to detect and measure atherosclerosis in these patients before it~     becomes permanent and potentially life threatening. Patients with this disease can~     participate in this study. Researchers plan to evaluate patients with homozygous familial~     hypercholesterolemia using new and standard methods for detecting atherosclerosis.~      Researchers plan to use information gathered during this study to develop new, promising~     treatments such as liver transplantation and gene therapy.~   "
274784|NCT00001203|"~     When patients receive repeated blood transfusions the level of iron in the patient s blood~     can rise. When iron is processed in the body a protein known as hemosiderin can begin~     collecting in the organs. If too much hemosiderin collects in the organs they can begin to~     malfunction. This condition is called transfusional hemochromatosis.~      An organ of particular importance in transfusional hemochromatosis is the heart. Patients~     born with diseases requiring blood transfusions at birth begin to develop heart problems in~     their teens. These patients typically only live for 17 years. Adults that require~     transfusions can begin experiencing heart problems after 100-200 units of backed red blood~     cells.~      Deferoxamine (Desferal) is a drug that binds to iron and allows it to be excreted from the~     body. It is the only effective way to remove iron from patients who have been overloaded with~     iron because of multiple transfusions. Previous studies have lead researchers to believe that~     deferoxamine, when given as an injection under the skin (subcutaneous), can be delay or~     prevent heart complications.~      Researchers plan to continue studying patients receiving deferoxamine as treatment for the~     prevention of heart complications associated with repeated blood transfusions. In this study~     researchers will attempt;~        1. To determine if deferoxamine, given regularly, can indefinitely prevent the heart,~          liver, and endocrine complications associated with transfusional hemochromatosis~        2. To determine whether heart disease caused by transfusional hemochromatosis can be~          reversed by intensive treatment with deferoxamine....~   "
274785|NCT00001202|"~     This study is a continuation of two previous studies conducted at the NIH. The first study ,~     Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone~     Analog (D-Trp(6)-Pro(9)-Net-LHRH) had less than optimal results. Some patients, all of whom~     were diagnosed with familial isosexual precocious puberty, had an inadequate response to the~     medication and were observed to have high levels of testosterone, advanced bone aging, and~     other complications of the disease. As a result these patients were enrolled in a second~     study~      In the second study, Spironolactone Treatment for Boys with Familial Isosexual Precocious~     Puberty, - the patients received another medication, spironolactone (Aldactone). The drug~     blocked the effects of testosterone, -but bone age advancement did not improve. Some patients~     began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe~     these may be the effects of elevated levels of estrodiol (a form of the female hormone,~     estrogen).~      In the present study, testolactone is added to the drug regimen to block the production of~     estrogen. The study therefore uses spironolactone to prevent the action of the male hormones~     (androgen) and testolactone to block the production of female hormones (estrogen).~     Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the~     drug regimen once true puberty begins. This is because it is know that boys with familial~     male precocious puberty go into true puberty too early (despite treatment with spironolactone~     and testolactone), and when that happens, the spironolactone and testolactone are no longer~     as effective. The goal of the treatment is to delay sexual development until a more~     appropriate age and prevent short adult stature (height).~   "
274786|NCT00001201|"~     The peripheral nervous system is the portion of the nervous system outside of the brain and~     spinal cord. It includes the 12 pairs of cranial nerves, 31 pairs of spinal nerves and their~     branches, nerves responsible for sensation and maintenance of normal body functions~     (sympathetic and parasympathetic nerves).~      Years of research using clinical examinations, microscopic examinations, and~     electrophysiology have made the peripheral nervous system the best-studied and most available~     portion of the nervous system. However, even with all of the extensive studies conducted on~     the peripheral nervous system, many conditions remain unclassified.~      The EMG Laboratory at the NIH concentrates on studying disorders of the peripheral nervous~     system. This protocol was designed to allow the EMG Laboratory to;~      I) Learn more about established diseases of the peripheral nervous system~      II) Identify and characterize new diseases of the peripheral nervous system~      III) Assess current techniques in the diagnosis of diseases of the peripheral nervous system~      IV) Refine old methods and develop new ones for the diagnosis of diseases of the peripheral~     nervous system.~   "
274787|NCT00001198|"~     A study of children and adolescents (current N=100) with very early onset by age 12 (COS) of~     DSM-III-R defined schizophrenia with (97-M-0126) is examining the clinical, neurobiological,~     early neurodevelopmental, genetic, and clinical drug response characteristics of these cases.~     Earlier studies have documented the continuity between COS and adult onset cases (See~     Jacobsen and Rapoport, 1998 for review). The focus has now shifted to increasing the sample~     size and evaluation of familial risk factors including: psychiatric diagnoses of family~     members; smooth pursuit eye movements; neuropsychological tests deficits, and obtaining blood~     for cell lines for genetic studies (family members only, this is also covered under~     96-M-0060, Dr. Ellen Sidransky).~      A study of obstetrical records of COS probands indicated no increase in adverse pre or~     perinatal events for these cases compared with obstetrical records of their siblings~     (Nicolson et al submitted). In contrast, several findings point to increased risk for these~     probands. To date, a total of 5 (10.4%) COS subjects were found to have previously unknown~     cytogenetic abnormalities (Microdeletion of 22q11 (3 cases), (Usiskin et al, submitted),~     Mosaic 45X0 (one case) (Kumra et al, 1998) and balanced 1:7 translocation (Gordon et al~     1994).~      The study of first degree relatives of these very rare cases addresses the hypothesis that~     risk factors, most probably genetic, are increased in immediate family members relative both~     to community controls and to the relatives of patients with chronic, treatment resistant,~     adult-onset schizophrenia (AOS). A second hypothesis is that COS familial risk factors show~     significant relationship to the developmental delays/abnormalities being observed in the COS~     probands. As a total of 50 additional COS subjects will be studied over the next 5 years, the~     pediatric control sample for the probands will also be increased, determined by the need to~     have concurrent measures for patients and controls to maintain measurement validity. Thus a~     total of 600 additional subjects are to be studied including 50 controls for COS probands,~     150 COS relatives, 150 controls for COS relatives, and 250 relatives of adult onset~     schizophrenics (AOS).~   "
274788|NCT00001197|"~     A total of fifty severely affected patients with homozygous sickle cell disease or other~     sickling disorders (e.g. B negative or B positive Thalassemia/Sickle) who are greater than 18~     years of age will be eligible for treatment. Such patients must be able to tolerate an~     extensive period without blood transfusion and have relatively well preserved renal and~     hepatic function (creatinine less than 1.5 mg/dl and normal liver function test with~     exception of a mild elevation in transaminase). Evidence of severe sickle cell anemia will~     include recurrent pain crisis, chronic bone oain, evidence of aseptic necrosis with symptoms,~     and intractable leg ulcer, etc.~      On admission to the study, each patient will receive a complete history and physical~     examination. These data and standard laboratory evaluation, including a test for pregnancy if~     appropriate, will be adequate to ascertain whether any of the criteria for exclusion are~     present. Each patient must accept responsibility for for using an effective means of~     contraception. Patients who are found to be HIV positive will be excluded from the study.~   "
274789|NCT00001196|"~     This study will evaluate patients with complaints of dry mouth to determine the cause and~     severity of their salivary gland dysfunction and their possible eligibility for other NIDCR~     protocols. Salivary gland secretions have antibacterial, lubricatory, remineralizing,~     digestive, buffering and cleansing properties. Impaired function of these glands can cause an~     increase in tooth decay; a variety of oral hard and soft tissue changes, with painful,~     burning, or ulcerated oral mucosal; problems chewing, swallowing, and speaking; and~     diminished taste and smell.~      Patients with dry mouth complaints suggestive of salivary gland dysfunction may be eligible~     for this study. In addition, patients with recent onset of arthritis may enroll. Patients~     with arthritis are at risk for developing a disorder called Sjogren's syndrome, in which the~     glands that produce saliva may be damaged.~      Participants will have a complete medical and dental history. Saliva samples will be~     collected from the major salivary glands, which are located in the cheeks and under the jaw.~     Several blood samples will also be drawn for tests. Some patients will have a biopsy of the~     minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of~     Sjogren's syndrome and determine the extent of changes in the salivary glands. The ability to~     taste and smell may also be evaluated, and patients may have an ultrasound examination of~     their swallowing function.~   "
274790|NCT00001195|"~     Researchers would like to determine normal ranges for hormone levels and to learn more about~     the genetics involved in hormone production and action. Researchers will take samples of~     blood, urine, saliva, and stool from healthy children ages 5-17 in order to study different~     aspects of hormones.~      Establishing a range of normal hormone levels in children will make diagnosing illnesses with~     abnormal levels of hormones much easier. Hormone levels in the body can change throughout the~     day. By collecting samples at different times researchers hope to learn more about the normal~     daytime and nighttime patterns of hormone secretion. Because some hormone levels change with~     body size, researchers will also take measurements of patient's body composition.~      This study will involve children and observe them as inpatients or as outpatients. <TAB>~   "
274791|NCT00001192|"~     This study will allow researchers to use various types of tests to evaluate cognitive and~     sensory functions. These tests, referred to as batteries will evaluate attention, executive~     functions, general intellectual functioning, language, memory, motor functions, orientation,~     personality, selected sensory and perceptual functions, vigilance (alertness), and~     visual-spatial functions. Children and adult patient will receive different test batteries.~      The goals of this research study are to;~        1. Create descriptions based on the performance of each patient on the test batteries. Then~          use this information to relate patient behavior to their neurophysiological,~          neuroradiological, and biochemical descriptions.~        2. Define subgroups of patients based on their neurobehavior in order to decrease the~          variability of psychiatric diagnoses, treatments, and prognoses.~   "
274799|NCT00001180|"~     Corticotropin Releasing Hormone (CRH) is a hypothalamic hormone made up of 41 amino acids.~     Amino acids are proteins that when combined make up different substances, like hormones. The~     order of amino acids in CRH, has been determined, meaning that the hormone can now be~     synthetically reproduced in a laboratory setting.~      When CRH is released from the hypothalamus it stimulates the pituitary gland to secrete~     another hormone, ACTH. ACTH then causes the adrenal glands to make a third hormone, cortisol.~     This process is known as the hypothalamic-pituitary-adrenal axis. Problems can occur in any~     of the steps of this process and result in a variety of diseases (Cushing's Syndrome and~     adrenal insufficiency).~      Researchers hope that CRH created in a laboratory setting, ovine CRH (oCRH) can be used to~     help diagnose and treat conditions of the HPA axis. This study will test the relationship for~     single doses of oCRH in normal volunteers and patients with disorders of the HPA axis. The~     oCRH will be injected into the patients vein as a single injection or slowly through an IV~     line over 24 hours. The participants will have blood tests taken to measure hormone levels~     before, during, and after receiving the oCRH.~   "
275390|NCT00000262|"~     The purpose of this study is to determine the effects of combined sevoflurane and nitrous~     oxide inhalation on mood, psychomotor performance, and the pain response in humans.~   "
274792|NCT00001191|"~     Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal~     tract, higher than normal levels of gastric acid, and tumors of the pancreas known as~     non-beta islet cell tumors. Patients with Zollinger-Ellison Syndrome require continuous~     control of their gastric acid secretion. If gastric acid levels are permitted to rise higher~     than normal, patients may develop severe ulcers and other complications.~      This study will attempt to determine the effectiveness of Omeprazole (Prilosec) in the~     treatment of patients with Zollinger-Ellison Syndrome. Omeprazole is a drug that functions to~     decrease the amount of gastric acid secreted.~      Patients for this study will be selected based on a previous diagnosis of Zollinger-Ellison~     Syndrome and/or idiopathic (unknown cause) high levels of gastric acid secretion. The~     patients will undergo an evaluation including history and physical examination as well as~     necessary laboratory tests. The proper dose of Omeprazole will then be determined in each~     patient . The proper dose of Omeprazole is considered the minimum amount of omeprazole~     required to lower gastric acid to a safe level.~      Every year patients participating in this study will undergo a physical examination and~     history. They will be questioned about symptoms associated with Zollinger-Ellison Syndrome.~     Gastric acid levels will be taken and evaluated and patients will undergo an upper~     gastrointestinal endoscopy.~      The effectiveness of the treatment will be measured by a clinical history to determine the~     control of symptoms due to high levels of gastric acid secretion.~   "
274793|NCT00001186|"~     Background:~        -  Cancer has an enormous impact on the psychological and social well-being of the family~          unit. The life-threatening connotations of cancer single out the ill child from his~          peer/family group as one who is different, and often unable to maintain a normal~          lifestyle. Physical sequelae of cancer and its treatment accentuate the differences~          between these children and their normal peers/siblings.~        -  It is important that children with cancer be prepared to function outside of protected~          situations and begin to develop skills of separation and independence. For healthy~          children, some of these latter skills are acquired by a camping experience. Such an~          experience for the patient with cancer is frequently precluded by their dependence on~          medical facilities and the physical limitations of their activities.~        -  The goal of this study will be to assess the short and long term benefits of the~          normalized camping experience, provided in conjunction with Special Love, Inc., on the~          patients and staff. In particular, we will seek to determine whether such a~          comprehensive experience is capable of influencing the attitudes and life experiences of~          patients and staff in a positive manner.~      Objectives:~        -  To evaluate the impact of an enriched normalized camping experience on the quality of~          life of the pediatric cancer patient. In particular, attempts will be made to measure~          the manner in which this experience influences the child's sense of well-being and~          self-esteem as well as his or her relationship with parents, family, and peers.~        -  To provide the atmosphere of a camping experience to the professional and volunteer care~          givers with the hope that they will utilize this experience in improving the quality of~          their interrelations with the patient population.~      Eligibility:~        -  Children 7-17 years of age who are currently being treated for cancer or are up to 3~          years post therapy OR Young adults with cancer (YACers) who are acting as counselors at~          Camp Fantastic~        -  All children/young adults will be selected for camp after careful screening by a~          multidisciplinary committee consisting of medical and program directors.~        -  At the discretion of the multidisciplinary committee consisting of medical and program~          directors, special exceptions may be made for children with extenuating circumstances.~      Design:~        -  Assessment of benefit may include interviews with children and families before, during~          and following camp. Observational data on the child's performance at camp will be noted.~        -  Medical and nursing personnel will consist of staff from the Pediatric Branch at the~          NCI, other units within the NIH, and participating institutions.~        -  Special Love members, the Program Director at the 4-H Center camp (site of the camp) and~          Pediatric Branch staff at the NCI will coordinate the camp program, taking into account~          the medical needs of each camper.~        -  Every attempt will be made to provide a full agenda of age appropriate activities for~          the patients.~        -  The length of the camping experience for children with cancer will be for 7 days~          beginning on a Sunday and extending through the following Saturday morning. Patients~          will be transported to the camp from the NIH Clinical Center and the Virginia hospitals~          by bus.~   "
274794|NCT00001185|"~     Polio or poliomyelitis is the disease caused by the poliovirus. The virus attacks cells in~     the spinal cord and causes symptoms of fever, sore throat, headache, vomiting, and stiffness~     of the neck. Patients with polio can have long-term weakness of muscles as a result of the~     damaged cells in the spinal cord. Occasionally, patients that recover from the disease can~     experience a relapse of muscle weakness. This can occur as long as 25-35 years after first~     having polio. The condition is called post-polio syndrome.~      Not all nerve cells in the spinal cord are damaged by the poliovirus. Some nerve cells remain~     healthy and take over the work of the damaged cells. Researchers believe that the post-polio~     syndrome may be caused by failure of these overworked nerve cells. However, what causes~     these overworked nerve cells to disintegrate is unknown.~      The purpose of this study is to apply specific scientific tests to answer important questions~     about the causes and development of the post-polio syndrome. Researchers will investigate~     possible genetic, immunologic, and physiologic causes of the post-polio syndrome. The study~     itself will not provide therapy for patients with the condition, but may lead to the~     development of therapies in the future.~   "
274795|NCT00001184|"~     This study will investigate in patients with Crohn s disease and ulcerative colitis how the~     body s immune system controls inflammation in the gastrointestinal tract (stomach and~     intestines) specifically, how lymphocytes (a type of white blood cell) function in~     inflammatory responses. This protocol does not involve any experimental treatments.~      Patients between the ages of 8 and 75 years of age with Crohn s disease or ulcerative colitis~     or symptoms of inflammatory bowel disease may be eligible for this study. Screening tests may~     include the following: medical history and physical examination, routine blood tests,~     examination of stool specimens, X-rays such as barium enema or upper GI series,~     proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel biopsy.~      Participants will receive medical treatment according to the best generally accepted measures~     for treating Crohn s disease or ulcerative colitis. This may include anti-inflammatory drugs,~     immunosuppressive drugs, and antibiotics to treat infections. A surgical consultation may be~     recommended for patients whose disease does not respond to medical treatment. If surgery to~     remove intestinal tissue is recommended, a qualified gastrointestinal surgeon will perform~     the procedure.~      In addition, participants may undergo the following procedures:~        -  Blood drawing No more than 450 milliliters (30 tablespoons, or 15 ounces) of blood will~          be taken from adults over a 6-week period. A maximum of 7 ml (1/2 tablespoon) of blood~          per kilogram (2.2. pounds) of body weight will be obtained from children within the same~          time period, with no more than 3 ml/kg taken at any one time.~        -  Leukapheresis This procedure is done to collect large quantities of white blood cells.~          Whole blood is collected through a needle in an arm vein, similar to donating blood. The~          blood is circulated through a machine that separates it into its components, and the~          white cells are removed. The rest of the blood is returned to the body, either through~          the same needle or through another needle in the other arm.~        -  Intestinal biopsies Intestinal tissue will be obtained during colonoscopy with~          intestinal biopsy in patients who require this procedure as part of their standard~          medical care. Patients are given a sedative to reduce anxiety, but are conscious during~          the procedure. A flexible tube is inserted into the rectum and large intestine, allowing~          the physician to see the intestinal mucosa. At various places, small pieces of tissue~          are plucked out.~   "
274796|NCT00001183|"~     Chronic lung diseases are disorders associated with abnormalities in any of the structures~     involved in the process of breathing and bringing oxygen into the lungs and blood. This~     includes abnormalities in the airways, lungs, blood vessels in and around the lungs, and the~     tissue covering the lungs (pleura).~      The purpose of this research study is to evaluate patients referred to the Cardiovascular and~     Pulmonary Branch of the National Heart, Lung, and Blood Institute (NHLBI) in order to;~        1. <TAB>Develop a better understanding of the causes and disease processes involved in~          disorders of the lungs~        2. <TAB>Identify patients eligible to participate in other P-CCMB research studies~   "
274797|NCT00001182|"~     This study offers evaluation and treatment of patients with unusual diagnostic or treatment~     considerations. It is not designed to test new treatments; rather, patients will receive~     current standard of care treatments. The purposes of the study are: 1) to allow NIDCR staff~     an opportunity to maintain and improve their clinical skills; and 2) to evaluate referred~     patients for research potential. (Participants in this protocol will not be required to join~     a research study; the decision will be voluntary.)~      Patients in need of dental/oral diagnosis and therapy of interest to NIDCR staff dentists may~     be eligible for this protocol. Participants will have a comprehensive dental examination and~     may receive part or all of their treatment at the NIDCR clinic. Diagnostic procedures,~     materials and treatments used in this study are limited to those widely accepted in dentistry~     and are non-experimental in nature.~   "
274798|NCT00001181|"~     The normal changes of puberty, such as breast enlargement, pubic hair and menstrual periods,~     usually begin between the ages of 9 and 15 in response to hormones produced in the body. Some~     children's bodies produce these hormones before the normal age and start puberty too early.~     This condition is known as precocious puberty.~      The hormones responsible for the onset of puberty come from the pituitary gland and the~     ovaries. The hormones from the pituitary gland act on the ovaries to produce different~     hormones that cause the breasts to grow, pubic hair to develop, and menstruation.~      Many children with precocious puberty can be treated with a medication known as lutenizing~     hormone-releasing hormone analog (Lupron, Histerelin, Deslorelin). This drug is made in a~     laboratory and is designed to act like the natural hormone LHRH, which is made in the~     pituitary gland. The drug causes the pituitary gland to decrease the amount of hormones it is~     releasing and thereby decrease the amount of hormones released by the ovaries. However, some~     girls already have low levels of pituitary hormones and yet their ovaries still produce~     hormones. Researchers do not believe that LHRH analog therapy will work for these children.~      Testolactone is a drug that acts directly on the ovary. It works by preventing the last step~     of estrogen production in the ovary. The goal of this treatment is to stop estrogen~     production and delay the onset of puberty until the normal age.~      Researchers will give patients with LHRHa resistant precocious puberty Testolactone for six~     months. If the initial treatment is successful and patients do not experience very bad side~     effects, they will continue to receive the medication until puberty is desired. Throughout~     the therapy patients will receive frequent monitoring of their general state of health,~     hormone levels, and medication levels.~   "
274804|NCT00001172|"~     This study is designed to understand how we see visual patterns and how these patterns lead~     to eye movements.~      Normal volunteers participating in this study face a screen on which spots or patterns of~     light are projected. They are asked to respond to the patterns by voice, eye movements or~     hand movements. Eye and lid movements are recorded in one of the following ways:~        1. Electro-oculogram < small disc electrodes taped to the skin near each eye measure the~          eye movements as the eyes change position.~        2. Infrared detector < an infrared beam is reflected off the eye and picked up by detectors~          that record the eye movements.~        3. Contact lens ring < a smooth plastic ring is placed on the white of the eye surrounding~          the cornea and eye position is measured using a magnetic coil.~      Study sessions last less than four hours.~   "
274805|NCT00001171|"~     Presently, patients with primary malignant brain tumors have a life expectancy of 15 weeks~     following surgery unless they receive additional types of therapy (chemotherapy,~     radiotherapy, and/or immunotherapy). Patients that receive additional therapy can increase~     life expectancy to 50 weeks.~      The statistics on the life expectancy and survival have increased efforts among researchers~     to develop new treatments for primary malignant brain tumors.~      This research project involves the growth and study of human brain tumor cells outside the~     body in the laboratory as part of an attempt to better understand these tumors and to develop~     more effective treatments for them.~   "
274806|NCT00001170|"~     This research study is the continuation of a study started more than 20 years ago. The study~     was designed to explore the effect that depressed parents have on their children and to~     better understand the factors that contribute to depression development and maintenance.~      The study will continue to investigate if children have certain characteristics in early and~     middle childhood that predict the later development of psychological disorders.~      In addition, the study will continue looking at the processes responsible for the development~     of children of parents with and without affective (mood) disorders.~   "
274807|NCT00001168|"~     Lipoproteins are particles that carry fats such as cholesterol and triglycerides through the~     blood stream. These particles are involved in causing blood vessel disease that can lead to~     conditions like hardening of the arteries (atherosclerosis) or heart attacks (myocardial~     infarctions).~      This study is designed to look closely at the factors affecting lipoproteins. Researchers~     plan to study patients and normal volunteers by measuring lipoprotein levels in the blood.~     Patients and volunteers will be placed on a balanced diet during the study. In addition,~     researchers plan to measure levels of various hormone and enzymes in the blood. Patients and~     volunteers participating in the study may be asked to undergo more specific tests in order to~     collect more information about lipoprotein metabolism.~      This study may not provide direct benefits to patients and volunteers participating in it.~     However, information gathered from this study may help researchers develop better skills and~     techniques to diagnose and treat patients with diseases of lipoprotein metabolism.~   "
274808|NCT00001167|"~     This study will assess the use of ultrasound-a test that uses sound waves to produce~     images-as a diagnostic tool for evaluating speech and swallowing.~      The following categories of individuals may be eligible for this study: 1) healthy volunteers~     between 20 and 85 years old with normal speech and hearing, 2) patients 6 to 85 years old~     with developmental neurological deficits in speech or swallowing, and 3) patients with tumors~     of the oral cavity, pharynx or larynx being treated at the Greater Baltimore Medical Center.~      Participants will undergo a 30-minute speech and oral motion evaluation, in which they~     imitate sounds, words and oral movements while a speech pathologist evaluates their lip,~     tongue and palate movements. They may also be asked to drink a small amount of water for~     examination of swallowing function.~      For the ultrasound examination, a 3/4-inch transducer (device for transmitting and receiving~     sound waves) is placed under the participant's chin. While the transducer is in place, the~     subject 1) repeats sounds and a series of syllables in several sequences, 2) swallows three~     times with and without a small amount of water, and 3) swallows 3 teaspoons of non-fat~     pudding. The ultrasound images are recorded on tape for later analysis.~   "
274809|NCT00001166|"~     Gyrate atrophy is a rare hereditary disease of the eye's retina (the layer of light-sensitive~     tissue that lines the inside of the eyeball) and choroid (a vascular layer of tissue behind~     the retina). Degeneration of these structures causes near-sightedness, cataracts and~     progressive loss of vision. This study will examine eye function and chemical and molecular~     abnormalities in patients with gyrate atrophy to try to better understand, diagnose, and~     treat the condition. Patients with other degenerative diseases of the choroid and retina,~     such as retinitis pigmentosa, choroideremia, and others, will also be studied for comparison.~     Family members of patients will be studied, when possible, to try to identify the genetic~     basis of the disease and gain information that will aid in genetic counseling.~      Study participants will undergo a physical examination and eye examination, including tests~     of color vision, field of vision, and ability to see in the dark. An electroretinogram and~     electrooculogram will measure visual cell function. Photographs of the retina will be taken.~     Blood will be drawn for biochemical study and gene research. Family members who agree to~     participate in the study will undergo the same eye tests and will also have blood drawn for~     genetic studies. Patients with gyrate atrophy will also be asked to undergo a small skin~     biopsy for biochemical and genetic study. They will provide a family history in order to draw~     a family tree showing how the disease is distributed among family members.~      Patients with gyrate atrophy may also participate in studies of the effect of vitamin B6 and~     diet on blood levels of the amino acid ornithine, which is elevated in patients with gyrate~     atrophy. Participants will take 500 mg of vitamin B6 by mouth every day for 3 to 6 months. If~     this study confirms a reduction of ornithine levels, then long-term studies of the vitamin as~     a possible treatment for the disease may be started.~      After the vitamin B6 study, patients will start a nearly protein-free diet to lower ornithine~     blood levels. More than 2,000 calories are carbohydrate and fat. Some special low-protein~     foods and limited fruit is included, plus amino acid supplements. Patients who have carefully~     adhered to this diet have lowered their ornithine levels and slowed disease progression.~     Patients will be hospitalized for the first 1 to 3 weeks for close monitoring with frequent~     urine and blood tests. When the blood ornithine level is normalized, a less restricted low~     protein diet will be prescribed. Participants will have monthly blood tests and a complete~     eye examination every 6 months to 1 year to evaluate disease progression.~   "
274810|NCT00001165|"~     Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal~     tract, higher than normal levels of gastric acid, and tumors of the pancreas known as~     non-beta islet cell tumors.~      Prior to the use of drugs to cure the ulcers, patients typically died due to severe ulcers.~     Because of such effective drugs to treat the ulcers it is more common to see patients dying~     due to the pancreatic tumors.~      The study will observe patients suffering from Zollinger-Ellison Syndrome and non-beta islet~     cell tumors and determine the effectiveness of combined chemotherapy with streptozotocin,~     5-fluorouracil, and doxorubicin.~   "
274871|NCT00000450|"~     The purpose of this study is to determine the long-term effectiveness of naltrexone treatment~     in alcohol-dependent patients who respond to short-term treatment. Those who respond to~     short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled~     maintenance phase with a 6-month posttreatment followup.~   "
274811|NCT00001163|"~     This is a clinical, epidemiologic, genetic, and laboratory study of individuals and families~     at high risk of cancer and selected tumors to investigate the genetic susceptibility and~     environmental exposures which may alter cancer risk. Families with multiple members who have~     an unusual pattern or number of cancers or tumors are evaluated clinically. This evaluation~     is specific for the type of cancer or tumor predominant in the family in order to determine~     the affection status of each individual for genetic epidemiologic studies. Genetic and~     environmental risk factor information specific for the tumor type is obtained.~      Individuals with, or at high risk of, cancer because of their personal, familial, or~     environmental histories are identified by healthcare worker referral or by personal inquiry.~     Relevant etiologic risk factor information is documented through review of pathology~     specimens and medical, vital, and genealogical records. Selected individuals and family~     members are asked to complete questionnaires and to undergo clinical evaluations specific for~     the tumor of interest. They are also asked to donate biologic specimens to be used in the~     search for cancer etiology and mechanisms of carcinogenesis. No therapy beyond counseling and~     education for cancer prevention, risk reduction, and early detection will be given.~      Genetic testing for tumor susceptibility gene(s) mutations and risk notification will be~     offered to study participants for whom a specific mutation predictive of disease has been~     identified in his/her family. This testing will only be offered when reasonable individual~     cancer risk estimates can be delivered, and only to those participants who choose to know~     their individual genetic status after appropriate education and counseling. The testing will~     be conducted exclusively in Clinical Laboratory Improvement Amendments (CLIA)-licensed~     laboratories. Genetic testing and risk notification are entirely optional and do not affect~     participation in other aspects of the protocol. A separate consent procedure and consent form~     will be used for genetic testing and risk notification related to these specific genes.~      Once enrolled, study participants are monitored prospectively for the development of outcomes~     of interest, typically by means of periodic mail or telephone contact. In selected instances,~     subjects may return to the Clinical Center periodically for study-specific follow-up~     examinations. Although we do not offer specific anti-cancer therapy as part of this protocol,~     we provide assistance to insure that study participants who require treatment for~     tumor-related problems that develop during the course of the study are referred to~     appropriate healthcare providers. We remain available to study participants and their~     healthcare providers for advice and consultation related to the management of familial~     cancer/tumor predisposition.~   "
274812|NCT00001162|"~     This protocol offers diagnosis and standard medical treatment for various parasitic~     gastrointestinal infections. Gastrointestinal parasites are either worms (helminths) or~     one-celled animals called protozoans which live in the human intestines. Often, parasitic~     infections do not cause illness. In these cases, drug treatment is not indicated, because~     treatment can have adverse side effects. Patients will be examined for their immune~     responses, correlation between the number of parasites and disease, and other studies.~      Individuals with known or suspected parasitic diseases of the gastrointestinal tract,~     including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm,~     trichinosis, clonorchis, opisthorchis, coccidiosis, paragonimiasis, and echinococcus may be~     eligible for this study.~      Patient evaluations may include blood and urine tests, stool examination, X-rays, ultrasound~     studies and, uncommonly, duodenal aspiration for examination of fluid from the duodenum~     (first part of the small intestine). Other tests may be required, depending on the parasite~     and disease. Direct examination of the tissues of the intestines may be required to rule out~     certain infections.~      Research procedures include collection of stool, blood and duodenal fluid when the diagnosis~     has been established and these procedures are not required for medical care. Patients with~     strongyloidiasis may also be given a diagnostic skin test similar to skin tests for~     tuberculosis and allergies. Research procedures on children will be limited to collection of~     stool, urine and blood. No more than 7 milliliters (1 1/2 teaspoons) per kilogram (2.2~     pounds) body weight of blood will be collected in children over a 6-week period. In adults no~     more than 30 tablespoons of blood will be collected in a 6-week period.~      Parasites may fail to respond to treatment. In these cases, it may be necessary to grow the~     parasite in the laboratory in order to test treatments in the test tube. Patients who do not~     respond to standard medications and dosing may need different doses of drugs or drugs or~     combinations of drugs used in the United States for other medical problems. If these~     medications or doses are used, patients will be informed of their possible side effects.~   "
274813|NCT00001161|"~     This study will investigate congenital or developmental eye abnormalities that affect the~     iris, cornea and lens, and are usually accompanied by elevated pressure within the eye. These~     disorders can cause vision loss, and the increased eye pressure can lead to glaucoma, a~     condition that may also cause loss of eyesight.~      Patients with eye anterior chamber eye disease, such as Axenfeld's syndrome, Rieger's~     anomaly, Peter's anomaly, iridocorneal endothelial syndrome, megalocornea, ocular~     hypertension, and others, are eligible for this study. Participants will have a medical~     examination, family history, and comprehensive eye examination. Tests and procedures may~     include photographs of the cornea, iris, and the structure through which fluid that normally~     circulates behind the cornea drains out of the eye. Some patients may undergo indentation~     tonography to measure how easily this fluid drains. In this procedure, the patient lies on an~     examination table and both eyes are numbed with eye drops. A small instrument (tonometer) is~     placed on the surface of one eye, and with the other eye, the patient looks at an overhead~     light. Other tests may include photographs of the back of the eye and ultrasound imaging of~     the structures of the eye. A blood sample may be drawn to study the genetic disorder~     responsible for the disease. Patients will have follow-up examinations every 6 months for the~     duration of the study.~      Medical or surgical therapy will be recommended, as appropriate, for patients who develop~     elevated eye pressure or vision loss.~   "
274814|NCT00001160|"~     Participants in this study will be patients diagnosed with or suspected to have a thyroid~     nodule or thyroid cancer.~      The main purpose of this study is to further understand the methods for the diagnosis and~     treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the~     context of standard medical care that is offered to all patients with thyroid nodules or~     thyroid cancer. Other tests are performed for research purposes. In addition, blood and~     tissue samples will be taken for research and genetic studies.~   "
274815|NCT00001159|"~     Participants in this study will be patients diagnosed with or suspected to have a thyroid~     function disorder. These conditions may include: hypothyroidism, hyperthyroidism, thyroid~     hormone resistance, Graves' Dermopathy, and thyroid-stimulating hormone (TSH) secreting~     pituitary adenomas.~      The main purpose of this study is to further understand the natural history, clinical~     presentation, and genetics of thyroid function disorders. Many of the tests performed are in~     the context of standard medical care that is offered to all patients with thyroid function~     disorders. In addition, blood and tissue samples may be taken for research and genetic~     studies....~   "
274816|NCT00001156|"~     Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown,~     but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that~     cause the body's immune system and natural defenses to attack healthy cells. In the case of~     MS, the immune system begins attacking myelin, the cells that make up the sheath covering~     nerves. Without myelin, nerves are unable to transmit signals effectively and symptoms occur.~      This study is directed toward a better understanding of the cause of Multiple Sclerosis (MS).~     Researchers will evaluate patients with a tentative diagnosis of MS or other neurological~     diseases possibly caused by a immunological reaction. Patients will undergo a series of three~     MRIs, taken once a month for three months and submit blood samples for immunological studies.~   "
274817|NCT00001155|"~     The purpose of this protocol is to continue to treat patients with Wegener's granulomatosis~     who have already entered the study, and to treat new patients. The investigators will attempt~     to correlate the clinical response with specific immunosuppressive effects of drug~     administration. The investigators are accumulating data on the optimal duration and side~     effects of therapy.~   "
274818|NCT00001154|"~     Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the~     blood. This study is designed to improve understanding of normal, as well as abnormal,~     lipoprotein metabolism and the role it plays in the development of hardening of the arteries~     (atherosclerosis).~      Patients participating in this study will receive injections of lipoproteins or~     apolipoproteins (the protein component of lipoproteins) that have been isolated and purified.~     These lipoproteins will be labeled with small amounts of radioactive material and sterilized~     before they are injected into the patient.~      Patients participating in the study will be required to have blood samples taken, and provide~     urine samples throughout the course of the study. In addition, patient will be required to~     follow a specially formulated diet. Patients will be weighed throughout the course of the~     study.~   "
274819|NCT00001151|"~     Vitamin D in the diet undergoes changes in the liver and kidneys to several forms. Patients~     suffering from disorders with Vitamin D resistance are unable to absorb calcium from food.~     Patients diagnosed with these disorders will be evaluated and treated with high doses of~     another form of Vitamin D (1,25-dihydroxyvitamin D3). Patients will be monitored and observed~     throughout the study to avoid experiencing side effects from the medication.~   "
274820|NCT00001150|"~     The use of a suction blister apparatus has facilitated study of the immunologic capacity of~     human epidermal cells. We have been able to prepare purified populations of these cells after~     blister formation. Specifically, using the blister tops, we are able to enrich for epidermal~     Langerhans cells which are very potent stimulators in antigen presenting assays. Thus, this~     normal volunteer study provides an important source of fresh epidermal tissue from which we~     can study normal epidermal Langerhans cell function. In addition, we have recently used~     blister roofs in important experimental models of HIV-1 transmission. There is no other~     method available for assessing the biologic function of freshly isolated Langerhans cells~     without altering their milieu. It is a very safe and effective way to obtain human epidermal~     samples.~   "
274821|NCT00001149|"~     This study is designed to evaluate patients with uncontrolled seizures. Seizures can be~     associated with and monitored by abnormal electrical activity in the brain.~      In this study researchers will use video-electroencephalography (EEG) to monitor patients~     with uncontrolled or suspected seizures. EEG works by measuring electrical activity in~     different areas of the brain. The video-EEG allows researchers to examine changes in the EEG~     along with the clinical features of seizures as they occur.~      In addition to monitoring electrical activity of the brain, researchers will take frequent~     antiepileptic drug blood levels. These measures will allow researchers to learn more about~     how each drug is absorbed and metabolized in the body.~      The information collected in the study will be used to place patients into other scientific~     studies testing new therapies for epilepsy.~   "
274822|NCT00001148|"~     Glioblastomas, the most frequent malignant brain tumor in adults, are widespread in the~     brain, despite their discrete appearance on computed tomography (CT) or magnetic resonance~     imaging (MRI). While this tumor tends to spread widely in the brain, unlike other tumors of~     the body, it rarely metastasizes, or spreads, to other organs. Approximately 10 percent of~     patients with glioblastoma develop metastatic disease after radiation or brain surgery. In~     the absence of radiation or brain surgery, few patients have developed disease spread outside~     the brain.~      During surgery to remove tumors of other organs of the body, such as the lung, prostate,~     kidney, or ovary, cells from these tumors are routinely found in the bloodstream. These cells~     are believed to be the reason for the spread of these tumors. In the case of malignant brain~     tumors, this process of glioma (tumor) cells shedding into circulation has not yet been~     investigated.~      This study will determine whether glioma cells can be detected in the bloodstream of patients~     undergoing surgery. If glioma cells are absent, it may mean they are unable to penetrate the~     blood-brain barrier. If they are present, they presumably can penetrate into blood vessels~     but they may be recognized and eliminated by the immune system, or they may escape detection~     yet not be able to take hold in the new microenvironment. The results of the study will add~     to the knowledge of the biology of these highly malignant tumors.~      Study participants will be admitted to the hospital for 8 to 10 days. They will undergo a~     complete physical and neurological exam and blood and urine tests. An electrocardiogram will~     be performed, and x-rays may be taken. On the morning of surgery, the patient will receive~     sedation intravenously. A tiny plastic tube called a catheter will be introduced into a vein~     in the groin through needles. The catheter will be passed through to the jugular bulb, right~     above the jugular vein, on the same side as the tumor. The patient will then be taken to the~     operating room for surgery. During surgery, not more than one quarter of a unit of blood will~     be removed through the catheter. The catheter will be removed before the patient enters the~     intensive care unit. Another MRI will be taken after surgery.~      The study will enroll participants for 2 years. Patients will be followed at 3 months and 6~     months after the surgery to make sure the postoperative period is uneventful.~   "
274823|NCT00001147|"~     This study involves sampling blood from both normal volunteers and patients with diseases~     known or suspected to involve body chemicals called catecholamines. The blood will be used to~     establish normal values for plasma levels of catecholamines and related neurochemicals; to~     test for abnormal neurochemical patterns in patients; and to establish a bank of DNA from~     normal volunteers and from patients to be used in future studies about possible alterations~     of catecholamine-related genes.~      Study participants will report to NIH after fasting overnight except for water or noncaloric,~     noncaffeinated beverages. They must not have taken Tylenol for at least 5 days. Blood will~     then be drawn. DNA will be extracted and stored in the freezer for future studies.~   "
274824|NCT00001146|"~     This study will examine the effectiveness of omega-3 fatty acids, compounds found in plants~     and fish, in treating bipolar disorder.~      Some studies have indicated that omega-3 fatty acids may be effective in treating mood~     disorders.~      For example, one investigator has shown a correlation between the prevalence of major~     depression and the amount of fish consumed per capita worldwide. Others have found decreased~     amounts of EPA (one of the active ingredients in omega-3 fatty acids) in the red blood cells~     of patients with major depression. And a recent small study of patients with bipolar illness~     indicated that omega-3 fatty acids prevented relapses, especially of depression, in patients.~      Patients with bipolar disorder who are not benefiting satisfactorily on their current~     medications are eligible to participate in this study. Candidates will be screened with a~     psychiatric evaluation, routine blood tests, a urine test and other tests needed to monitor~     medications. Participants will be randomly assigned to one of two groups: one group will~     receive 6 grams of omega-3 fatty acid every day for 16 weeks; the second will receive a~     placebo (inactive capsule). In addition, patients in both groups will continue to take their~     previous medications. Every 2 weeks, all patients will have their vital signs checked and be~     evaluated for side effects and mood changes. At the end of the 16-week study period, all~     patients will be given the opportunity to continue in the study for another 8 months and~     receive active drug (omega-3 fatty acid). Patients who continue will be evaluated once a~     month and will have blood drawn on the last visit for routine tests.~   "
274825|NCT00001145|"~     The primary goal of this Phase I/II study is to assess the immune response and safety of~     recombinant human CD40 ligand (rhuCD40L) in patients with X-linked hyper IgM syndrome (XHIM).~     XHIM is a rare genetic disease caused by mutations in the gene encoding CD40 ligand.~     Individuals with this syndrome fail to make gamma immune globulin, frequently suffer from~     opportunistic infections, and are at an increased risk of developing cancer. Despite~     treatment with gamma globulin replacement therapy, the expected survival of patients with~     XHIM is less than 20 percent by the age of 25.~      In a mouse model of this syndrome, treatment with man-made CD40 ligand protein protected the~     mouse from opportunistic infections, restored the mouse's ability to make gamma globulin, and~     improved survival. We want to determine if a similar approach can work in humans with XHIM.~     The study will be conducted at the Clinical Center of the National Institutes of Health in~     Bethesda, Maryland.~      For most patients, rhuCD40L will be administered by injection under the skin over a period of~     six months and follow-up exams are required at 2-month intervals for an additional 6 months.~     During the study, patients will be maintained on intravenous gamma globulin, antibiotics to~     protect against opportunistic infection, and, if needed, growth factors to control~     neutropenia. The immune response to rhuCD40Lwill be measured by routine methods such as~     measuring a patient's ability to synthesize gamma globulin when challenged with immunizations~     to keyhole limpet hemocyanin (KLH) and Bacteriophage Phi-X 174 (Phi-X 174). Our long-term~     goal is to define a therapeutic regimen that will provide effective immunological~     reconstitution to patients with XHIM and improve their life expectancy.~   "
274826|NCT00001144|"~     This study will investigate the safety and effectiveness of a new stem cell transplant~     procedure for treating chronic myelogenous leukemia (CML).~      Transplantation of donated stem cells (cells produced by the bone marrow that mature into the~     different blood components-white cells, red cells and platelets) is a very effective~     treatment for CML. However, despite its success in a large number of patients, there is still~     a significant risk of death from the procedure. In addition, it results in sterility and~     leaves patients at increased risk for other cancers and for eye cataracts. These~     complications result from the intensive chemotherapy and radiation patients receive before~     the transplant to rid the body of cancer cells. In this study, radiation will not be used and~     chemotherapy drugs will be given in lower doses to try to reduce the dangers of the~     procedure.~      Patients with CML will be tested for matching with a donor (family member) and will undergo a~     medical history, physical examination and several tests (e.g., breathing tests, X-rays, and~     others) to determine eligibility for the study. Participants will then undergo apheresis to~     collect lymphocytes (white blood cells important in the immune system). In apheresis, whole~     blood is drawn through a needle in the arm, similar to donating a unit of blood. The required~     component-in this case, lymphocytes-are separated and removed, and the rest of the blood is~     returned through a needle in the other arm.~      Each day starting five days before the transplant, the donor will be given an injection of~     G-CSF, a drug that releases stem cells from the bone marrow into the blood stream. The cells~     will be collected after the fifth injection and again after a sixth injection the following~     day. Meanwhile, patients will be given cyclophosphamide and fludarabine, and perhaps~     anti-thymocyte globulin, to prevent rejection of the donated cells.~      On the day of the transplant, patients will be given cyclosporin to prevent~     graft-versus-host-disease, a disease in which the donor cells react against the patient's~     cells. They may also be given lymphocytes after the transplant to boost the immune system and~     destroy leukemia cells. After 30, 60 and 100 days, bone marrow cells and circulating~     lymphocytes will be checked to see how many are of donor cell origin. If less than 100~     percent are of donor origin, more lymphocytes will be transfused. Patients will have physical~     examinations and blood tests at least weekly for 3 months and then periodically for 5 years.~   "
274827|NCT00001143|"~     Little is known about the development of the ocular, or eye, motor system (the parts of the~     brain that control how the eyes move) in children. Recent technological and methodological~     advances now enable researchers to investigate the visual system and ocular motor system of~     infants, but few findings have been reported. This study hypothesizes that quantitative~     analysis of at-risk infants' eye movement systems can detect abnormalities that precede and~     predict the onset of strabismus, or cross-eye.~      We will collect data on the eye movements of a group of infants born between 36 and 44 weeks~     after conception. These infants will be enrolled between 4 and 24 weeks after birth and~     followed at 4-week (+/- 5 days) intervals until 28 weeks of age and then once a year until 3~     years after birth. The infants will undergo a complete ophthalmic evaluation at each visit~     after they enroll. At all visits up to 28 weeks of age, they will also undergo analysis of~     eye movements. We also will monitor the development of ocular alignment and check to detect~     other visual system abnormalities. The study will provide basic knowledge about the cause of~     both normal and abnormal alignment of both eyes in infants in the first 28 weeks of life.~   "
274828|NCT00000426|"~     This study looks at the effects of calcium supplementation on bone density in women in their~     third decade of life. We placed women aged 19-27 who take in low amounts of calcium in their~     diets in one of two groups. We will give women in one group a placebo (inactive pill) and~     women in the other group 1500 milligrams of calcium per day (as calcium carbonate). We will~     monitor the results by looking at the change in bone mineral density measured at the hip,~     total body, forearm, and spine. Treatment will last 3 years.~   "
274829|NCT00000425|"~     This study will determine if there is a difference between commonly used nonsteroidal~     anti-inflammatory drugs (NSAIDs) and acetaminophen (a pain-reliever that does not prevent~     inflammation) for treating knee pain in osteoarthritis (OA). The two main results we will~     look at are disease progression according to x-rays and disability over 3.5 years. Study~     participants with moderate knee OA and knee pain will continue taking their NSAID or stop~     taking their NSAID and start taking acetaminophen. Every 6 months we will send the~     participants questionnaires that ask about pain, medication use, and disability. We will take~     x-rays of the knees at the start of the study and again at the end of the study.~   "
274830|NCT00000424|"~     This study compared the effects of tidal lavage (washing out) of the knee joint and an~     imitation lavage procedure in people with knee osteoarthritis. In tidal lavage, the doctor~     flushes out a knee joint with repeated injections of a mild salt solution, done under local~     anesthesia. Study participants had to meet standard criteria for diagnosis of osteoarthritis~     but could have low, medium, or high severity of x-ray changes indicating knee osteoarthritis.~     We performed the lavage procedure once, and did quarterly followups for 1 year. We permitted~     patients to use some other osteoarthritis treatments during the study, such as non-narcotic~     pain relievers, nonsteroidal anti-inflammatory drugs, and physical therapy.~   "
274840|NCT00000414|"~     This project will evaluate the effectiveness and general usefulness of two arthritis patient~     education programs. The first, the Arthritis Self-Management Program, is a 6-week,~     community-based program taught in small groups by peer leaders. The second, the Self-Managed~     Arthritis Relief Therapy (SMART) Program, is a computer-driven program delivered through the~     mail. Participants in this project are people with rheumatoid arthritis or osteoarthritis who~     are taking part in the larger long-term studies being conducted by ARAMIS (the Arthritis,~     Rheumatism and Aging Medical Information System).~   "
274831|NCT00000423|"~     This study tests the effects of social support and education on the health and well-being of~     people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS~     from a large health maintenance organization. We randomly assigned the study participants to~     one of three groups. People in the social support group met with others who suffer from FMS~     for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The social~     support and education group also had 10 2-hour weekly meetings followed by 10 monthly~     meetings with others who suffer from FMS. Members of this group learned about the disease and~     ways they can manage it themselves. The third group participated only in the five assessment~     periods. The study lasted 4 years.~   "
274832|NCT00000422|"~     This study will evaluate the effects of matching treatments to people with fibromyalgia~     syndrome (FMS) on the basis of their psychosocial and behavioral characteristics. We will~     look at how patients respond to a rehabilitation program that includes physical therapy and~     information about fibromyalgia. We will combine this program with psychological treatments~     that are either matched or mismatched to the way patients cope with and adapt to symptoms of~     FMS. The second aim of our study is to better understand how different FMS symptoms may vary~     together and how these symptoms change as a result of treatment in a person's natural~     environment. People with FMS and healthy people of the same ages will record their moods,~     thoughts, symptoms, activities, and fatigue levels three times a day for 2 weeks.~     Participants will use palm-top computers to record these real-time assessments. This~     approach will permit people to rate how they feel at a particular time rather than looking~     back in time.~   "
274833|NCT00000421|"~     The first part of this study will use the database of a large, ongoing NIH-sponsored lupus~     study, Safety of Estrogen in Lupus Erythematosus National Assessment. We will examine the~     levels of a blood protein known as C3a in a series of patient blood samples to see if C3a~     levels predict lupus flares or are better than other blood tests, and therefore should be~     used more widely in managing lupus. In the second part of the study we will add or increase~     prednisone treatment on the basis of abnormalities in blood tests for C3a and dsDNA~     antibodies. Early treatment based on increases in C3a and dsDNA antibodies, before the~     patient develops physical signs of disease, may reduce lupus flares and, ultimately, the~     patient's total steroid exposure.~      We will follow study participants for 1 year on a monthly basis and do full physical~     examinations and laboratory evaluations. If C3a and dsDNA antibody levels are increased~     significantly above baseline levels while a patient is clinically stable, we will give the~     patient either prednisone or an inactive pill (placebo) for 1 month. We will follow these~     patients monthly to compare how often lupus flares occur in the two groups. This approach~     could provide a novel method of preventing lupus flares, using C3a as a sensitive predictor~     of flare.~   "
274834|NCT00000420|"~     Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test~     whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We~     will determine this by looking at the effects of oral contraceptives (birth control pills,~     also known as the pill) on disease activity and severity in women with SLE. The results of~     the study will show whether it is safe for women with SLE to use the pill.~   "
274835|NCT00000419|"~     Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test~     whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use~     the hormone estrogen. In this part of the study, we will look at the effects of estrogen~     replacement therapy on the activity and severity of disease in women with SLE.~   "
274836|NCT00000418|"~     Acute low back pain (severe pain that comes on suddenly and lasts a relatively short time) is~     very common in the United States, and accounts for substantial illness, functional~     limitations, pain, and health care costs. This study looks at whether a program designed to~     improve self-efficacy (a person's belief in his or her ability to reach a goal, such as~     managing one's own disease) and social support improves the health status of people with~     acute low back pain.~   "
274837|NCT00000417|"~     We will study the relationships among patient/partner communication, social support, and~     self-efficacy (a person's belief in the ability to manage his or her disease) as they affect~     the health of people with systemic lupus erythematosus (SLE, or lupus) over time. We are~     assigning 150 people with lupus and their partners to either (1) receive counseling to~     improve self-efficacy, partner support, and patient/partner problem solving or (2) see an~     informational film about lupus. We will follow study participants for 12 months to find out~     about their physical and mental health, disease activity, beliefs that they can take steps~     that help them feel better, coping, social support, and couples communication.~   "
274838|NCT00000416|"~     People with rheumatic disorders (arthritis) often have trouble keeping their jobs. This study~     will look at whether vocational rehabilitation (VR) will improve the ability of employed~     people with arthritis to keep their jobs. Job retention VR services target key factors that~     increase the risk of job loss. They aim to modify jobs to reduce barriers caused by~     functional limitations and disease symptoms, future career planning, and establish a~     partnership with a VR counselor for ongoing help.~      We will conduct the study among patients with rheumatic disorders recruited in eastern~     Massachusetts. We will give 120 study participants job retention services provided by VR~     counselors. We will give another 120 participants literature about employment- related~     resources. We will compare the outcomes of the two groups to evaluate the usefulness of job~     retention services in preventing job loss in people with rheumatic disorders.~   "
274839|NCT00000415|"~     Doctors recommend that young children participate in daily physical activity to promote bone~     health. However, studies in adults show that physical activity and increased calcium intake~     cause noticeable benefits for bone health only when both factors occur together. The goal of~     this study is to find out whether calcium intake changes the response of bone to activity in~     children 3 to 4 years old. Children will participate in one of two programs conducted in~     childcare centers 5 days a week for 1 year. One program will involve activities that use~     large muscles (gross motor activity). The other will involve activities using small muscles~     (fine motor activity). We will give a calcium supplement (1 gram per day) to half of the~     children in each program and give the other half an inactive pill. We will measure bone mass~     and bone mineral density at the beginning and end of the study. We will take measurements 12~     months after the program's completion to see if physical activity and/or calcium supplements~     have long-term effects on bone mineral density and physical activity.~   "
274842|NCT00000412|"~     During the first year after a heart transplant, people often rapidly lose bone from their~     spine and hips. About 35 percent of people who receive heart transplants will suffer broken~     bones during the first year after transplantation. This study will compare the safety and~     effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol)~     in preventing bone loss at the spine and hip after a heart transplant.~      In this study, people who have had a successful heart transplant will receive either active~     alendronate and a dummy pill instead of calcitriol, or active calcitriol and a dummy pill~     instead of alendronate for the first year after their transplant, starting within 1 month~     after transplant surgery. We will measure bone density in the hip and spine at the start of~     the study and after 6 and 12 months, and will also check for broken bones in the spine. This~     research should lead to ways of preventing this crippling form of osteoporosis.~   "
274843|NCT00000411|"~     This study tests the effectiveness of different treatments for the three most commonly~     diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of~     two commonly prescribed treatments (surgery and nonsurgical therapy) works better for~     specific types of low back pain. Low back pain is one of the most widely experienced health~     problems in the United States and the world. It is the second most frequent condition, after~     the common cold, for which people see a doctor or lose days from work.~      In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces~     in the backbone that results in pressure on the spinal cord and/or nerve roots) with a type~     of surgery known as posterior decompressive laminectomy or with nonsurgical methods. This~     study does not cover the cost of treatment.~   "
274844|NCT00000410|"~     This study tests the effectiveness of different treatments for the three most commonly~     diagnosed lumbar (lower) spine conditions. The purpose of the study is to learn which of two~     commonly prescribed treatments (surgery and non-surgical therapy) works better for specific~     types of low back pain.~      In this part of the study, people with lumbar intervertebral disc herniation (damage to the~     tissue between the bones of the lower spine, or backbone) will receive either discectomy~     (surgical removal of herniated disc material) or non-surgical treatment. This study does not~     cover the cost of treatment.~   "
274845|NCT00000409|"~     This study tests the effectiveness of different treatments for the three most commonly~     diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of~     two commonly prescribed treatments (surgery and nonsurgical therapy) works better for~     specific types of low back pain.~      In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces~     in the backbone that results in pressure on the spinal cord and/or nerve roots) caused by~     degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips~     forward on another) with either surgery or nonsurgical methods. This study does not cover the~     cost of treatment.~   "
274846|NCT00000408|"~     Back pain is one of the most common of all symptoms. It is also a great cause of days lost~     from work and visits to health care providers. This study will develop and evaluate an~     approach to low back pain that allows subjects to talk with each other and with health~     professionals via an Internet discussion group. Results we will look at include health~     behaviors, such as exercise; health status, such as pain and disability; and health care use,~     such as number of visits to doctors and other health care providers. Anyone 18 years old or~     older who lives in the United States and has ongoing Internet access can take part in the~     study. All subjects must have back pain and meet the eligibility criteria listed below.~   "
274847|NCT00000407|"~     The long-term objectives of this research project are to enhance program participation and~     improve the employment prospects of people with work disability due to arthritis and related~     musculoskeletal disorders (ARMD) who are actively seeking vocational (job-related)~     rehabilitation (VR) services.~      This study is designed to compare the employment situations of a group of people receiving a~     two-part intervention and a group that is not receiving the intervention. The intervention~     consists of training sessions to help prospective VR clients with ARMD successfully enter and~     complete the VR program, and training sessions for a randomly selected group of VR~     professionals to help them serve VR clients with ARMD more effectively.~   "
274848|NCT00000406|"~     To understand the effects of leg strengthening exercise, we will study the effects of~     strength training of the legs in four groups of people: (1) osteoarthritis (OA) with knee~     pain; (2) OA without knee pain; (3) no OA but elderly with knee pain; and (4) normal elderly~     with no OA or knee pain. In each of the first three groups, we will look at whether people~     who do strength training have less pain and/or slower progression of x-ray signs of OA over~     30 months than people who perform nonstrengthening, range-of-motion exercises. We are~     including the fourth group to find out whether people with OA (groups 1 & 2) have the same~     response to strength training as healthy elderly people, and whether those with knee pain~     (groups 1 & 3) have the same response to training as those without joint pain.~   "
274849|NCT00000405|"~     In this study we will investigate the effects of a high-impact exercise program involving~     jumping on bone mass (the amount of bone) of the hip and backbone in the growing skeleton. We~     will also look at the effects of gradually stopping the jumping program on bone mass in the~     growing skeleton. A high-impact exercise program may build more bone during childhood, while~     the skeleton is still growing. This may help prevent broken bones due to loss of bone mass~     later in life.~      We will recruit 200 children aged 5-10 to participate in the study. For 6 months we will~     train the children in either a jumping or stretching program. We will then gradually reduce~     the amount of exercise over 6 months. We will measure bone mass in the hip and backbone at~     the start of the study, after jumping, and 6 months after the jumping program is stopped. We~     will compare the results in the jumping and stretching groups.~   "
274860|NCT00000394|"~     This study will look at the effectiveness of acupuncture for treating carpal tunnel syndrome~     (CTS). People who participate in this study will have CTS that has been diagnosed by physical~     examination and neurological testing. We will randomly assign study participants to receive~     one of the three types of acupuncture either once, twice, or three times weekly for a total~     of 6 weeks. Acupuncturists will treat one group of patients with true acupuncture. They will~     give the other two groups of patients one of two alternative acupuncture treatments that do~     not use the true acupuncture points. The patients and evaluators will not know the type of~     acupuncture (True, Alternative 1, or Alternative 2) that is being used. The acupuncturists~     will not communicate with the patients and will not be involved in patient evaluation.~   "
274850|NCT00000404|"~     We will study 300 people with knee osteoarthritis (OA) who receive their medical care from a~     large health maintenance organization (HMO) in Indianapolis. Our study will evaluate a~     comprehensive plan for treatment of knee OA by primary care physicians. Primary care~     physicians will provide standard care for knee OA to half of the study participants (150~     people), and will use the comprehensive treatment plan guidelines to treat the other half.~     The comprehensive plan includes careful use of medications along with non-drug approaches~     such as patient education, exercise, and social support. People who participate in the study~     will receive care for knee OA for 1 year. We will measure the results (outcomes) of treatment~     at the start of the study and at 3 months, 6 months, and 12 months after patients join the~     study. The results we will measure include joint pain, physical function, drug side effects,~     quality of life, satisfaction with OA care, and the cost of medical care.~   "
274851|NCT00000403|"~     This study will determine whether doxycycline decreases the severity or rate of progression~     of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the~     most popular agents used to treat OA, but elderly women, in whom OA is especially common, are~     at greatest risk of developing serious side effects from NSAIDs.~      Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study~     participants will receive the treatment (doxycycline) and half will receive a placebo~     (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and~     participants and researchers will not know who is receiving doxycycline and who is receiving~     placebo until the end of the study. We will look for narrowing of the joint space in the knee~     that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA.~     We will also use questionnaires to evaluate participants' symptoms and functioning.~   "
274852|NCT00000402|"~     We originally suggested that calcium in the diet is important in determining the amount of~     bone (bone mass) that builds up in young adults. We are testing the effect of calcium on bone~     mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age of~     the girls was 11 years, and they had not yet reached puberty. The study will also provide~     information about the effect of calcium on body composition (body fat) and blood pressure in~     young women.~      We have been giving calcium to one group of participants in this study and giving a placebo~     (an inactive pill, or sugar pill) to the other group. The results of this research will be~     important in preventing osteoporosis, because building more bone as a young person should~     reduce a woman's chances of developing osteoporosis later in life.~   "
274853|NCT00000401|"~     Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation~     of the joints. In RA, the immune system attacks a person's own cells inside joints,~     eventually leading to joint damage and disability. This study will determine if oral bovine~     type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.~   "
274854|NCT00000400|"~     This study looks at the effects of two medications, alendronate and parathyroid hormone, on~     bone mass and on bone formation and bone breakdown in women with osteoporosis. We will~     randomly select postmenopausal women who have osteoporosis to receive laboratory-produced~     human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants~     will return to the study center periodically to have their bone mass measured and to give~     blood and urine samples for tests of bone formation and breakdown and for other laboratory~     tests. Those who complete the study are eligible for one or two 12 month extension studies.~   "
274855|NCT00000399|"~     We started the Bone, Estrogen, Strength Training (BEST) study in the fall of 1995 at the~     University of Arizona, Tucson, Arizona. The BEST study is the largest of its kind. It looks~     at the effects of hormone replacement therapy and strength training exercise on bone mineral~     density. (Bone mineral density affects bone strength and the risk of osteoporosis.) Six~     groups of about 300 women each participated in this osteoporosis prevention study. In 1998,~     the BEST study received additional funding to examine for another 2 years the long-term~     effects of strength training on bone mineral density. By 2001 we will have finished analyzing~     the results for all study groups on the 1-year effects of exercise on bone, as well as~     additional analyses on the effects of 2, 3, and 4 years of strength training and~     weight-bearing exercise on bone.~   "
274856|NCT00000398|"~     Fibromyalgia (FM) is one of the most common rheumatic diseases (conditions or disorders that~     cause pain or stiffness in the joints, muscles, or bones). It affects 6 million Americans and~     up to 20 percent of patients seen by doctors who specialize in treating rheumatic diseases.~     This study will evaluate the effects of two of the most promising nondrug treatments for FM:~     coping skills training and physical exercise training. We will randomly assign each of 180~     patients diagnosed with FM to one of four groups: coping skills training (CST), physical~     exercise training alone, CST plus physical exercise training, or a waiting list (nontreatment~     group). We will look at the separate and combined effects of CST and physical exercise~     training and evaluate how changes in aerobic fitness, self-effectiveness (a person's belief~     in his or her ability to reach a goal, such as managing one's own disease), and negative~     pain-related thoughts relate to improvements in pain and disability.~   "
274857|NCT00000397|"~     This study tests the effectiveness of a nondrug treatment for the insomnia that often occurs~     in people with fibromyalgia. The treatment is a type of psychotherapy called~     cognitive-behavioral therapy. Cognitive-behavioral therapy combines cognitive therapy, which~     can modify or eliminate thought patterns contributing to the person's symptoms, and~     behavioral therapy, which aims to help the person change his or her behavior.~   "
274858|NCT00000396|"~     Research has shown that people with arthritis can improve their ability to cope with~     arthritis pain with the help of patient education programs, which teach people things they~     can do to help manage their disease. However, we do not know much about the effects of~     arthritis patient education programs on minorities, such as urban African Americans.~      We will gather participants for this project through a faith-based community network. The~     project is made up of four studies that will provide information about culturally relevant~     ways of reaching urban African Americans with arthritis and providing patient education that~     addresses arthritis care needs of the African American community. This project will also~     provide information on the effectiveness of an arthritis self-help course for urban African~     Americans. We hope to better understand the differences among cultural groups and how these~     differences should affect the design of culturally appropriate patient education.~   "
274861|NCT00000105|"~     The purpose of this study is to learn how the immune system works in response to vaccines. We~     will give the vaccines to subjects who have cancer but have not had treatment, and to~     patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines~     while they are on treatments which boost the immune system (like the immune stimulating drug~     interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting~     drugs, we do not yet know if they improve the body's immune system to respond better to a~     vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control~     subjects to get a good measure of the normal immune response. We will compare the patients~     and the healthy volunteers to study how their immune systems respond to the vaccines.~      There are several different types of white cells in the blood. We are interested in immune~     cells in the blood called T-cells. These T-cells detect foreign substances in the body (like~     viruses and cancer cells). We are trying to learn more about how the body fights these~     foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to~     detect and kill cancer cells better. We know that in healthy people the immune system~     effectively protects against recurrent virus infection. For example, that is why people only~     get mono (mononucleosis) once under normal circumstances. When the body is infected with~     the mono virus, the immune system remembers and prevents further infection. We are trying~     to use the immune system to prevent cancer relapse. To test this, we will give two vaccines~     which have been used to measure these immune responses. Blood samples will be studied from~     cancer patients and will be compared to similar samples from normal subjects.~   "
274862|NCT00000104|"~     Inner city children are at an increased risk for lead overburden. This in turn affects~     cognitive functioning. However, the underlying neuropsychological effects of lead overburden~     and its age-specific effects have not been well delineated. This study is part of a larger~     study on the effects of lead overburden on the development of attention and memory. The~     larger study is using a multi-model approach to study the effects of lead overburden on these~     effects including the event-related potential (ERP), electrophysiologic measures of attention~     and memory are studied. Every eight months, for a total of three sessions the subjects will~     complete ERP measures of attention and memory which require them to watch various computer~     images while wearing scalp electrodes recording from 11 sites. It is this test that we are~     going to be doing on CRC. There will be 30 lead overburdened children recruited from the~     larger study for participation in the ERP studies on CRC. These 30 children will be matched~     with 30 children without lead overburden. This portion of the study is important in providing~     an index of physiological functioning to be used along with behaviorally based measures of~     attention and memory, and for providing information about the different measures.~   "
274863|NCT00000102|"~     This study will test the ability of extended release nifedipine (Procardia XL), a blood~     pressure medication, to permit a decrease in the dose of glucocorticoid medication children~     take to treat congenital adrenal hyperplasia (CAH).~   "
274864|NCT00000458|"~     This study will assess whether individuals treated with sertraline (Zoloft) and cognitive~     behavior therapy will experience improvement with their depression and consume less alcohol~     than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week,~     random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3~     months after treatment.~   "
274865|NCT00000457|"~     This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing~     the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from~     smoking with nicotine patch therapy. The study will also determine the cessation rate in the~     8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is~     projected to serve as a 100-percent replacement.~   "
274866|NCT00000456|"~     This study will compare cognitive behavioral therapy with a time-limited motivational~     enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this~     randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence,~     will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo~     for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse~     will be evaluated in all four groups along with measures of alcohol craving, biological~     measures of alcohol consumption, drinking consequences, changes in self-confidence for~     avoiding alcohol, and medication compliance. All study participants will be assessed for~     measures of outcome variables at 3 and 6 months after completing the treatment protocol.~   "
274867|NCT00000455|"~     Early problem drinkers are prevalent in the United States. Recent controlled trials have~     shown that brief interventions in the primary care setting can reduce drinking and~     alcohol-related problems in patients who lack evidence of alcohol dependence.~      Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few~     pharmacotherapy studies have been undertaken with early problem drinkers. This study is an~     8-week trial of naltrexone versus placebo, combined with coping skills treatment that either~     focuses on targeted use of medication or serves as background to daily use of the medication.~     A total of 160 early problem drinkers recruited through screening in primary care medical~     settings will be randomly assigned to one of four treatment groups. Followup evaluations will~     be conducted at the end of treatment and again 3, 6, and 12 months.~   "
274868|NCT00000454|"~     This study is designed to increase understanding of the processes that affect the treatment~     outcome of individuals with both alcohol and nicotine dependence. Treatment outcome~     methodology will be combined with a computerized self-monitoring methodology to examine the~     extent to which smoking serves as a cue for alcohol craving and/or as a response to alcohol~     craving in treated alcoholics. Subjects will be veterans participating in the Substance Abuse~     Day Programs at the Newington and West Haven campuses of the VA Connecticut Healthcare~     System. Nonveteran women will be recruited from the community and enrolled in the day~     program. Subjects will be randomly assigned to one of the following two conditions: (1)~     intensive smoking cessation therapy (counseling plus nicotine replacement using nicotine~     patches) concurrent with alcohol treatment, or (2) brief smoking cessation advice concurrent~     with alcohol treatment.~   "
275013|NCT00000530|"~     To determine the relative efficacy of usual medical care and a course of treatment by thermal~     biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to~     confirm the frequency and severity of attacks, examine the role of psychophysiological~     factors in precipitating attacks, and assess the influence of treatment on health quality of~     life.~   "
274883|NCT00000438|"~     This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating~     alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of~     their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge,~     individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or~     a placebo. This part of the study will last 12 weeks, with regular measurements of drinking~     level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of~     the study.~   "
274884|NCT00000437|"~     The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched~     placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in~     reducing drinking and smoking in patients with both nicotine and alcohol dependence.~   "
274885|NCT00000389|"~     The purpose of this study is to see if it is effective to treat children with anxiety~     disorders with fluvoxamine.~      Fluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults~     and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social~     phobia, or separation anxiety, are very common in youth and are not always responsive to~     behavioral therapies alone. These disorders may respond to fluvoxamine.~      A child will be evaluated for 3 weeks before he/she is assigned randomly (like tossing a~     coin) to receive either fluvoxamine or an inactive placebo for 8 weeks. After this~     double-blind phase (neither the child/parents nor the doctor know which treatment is being~     given), the child will have the option of continuing treatment during a 4-month open-label~     extension period (both the child/parents and the doctor know which the child is receiving).~      A child may be eligible for this study if he/she:~      Is 6 to 17 years old and has been diagnosed with an anxiety disorder (i.e., generalized~     anxiety disorder, social phobia, or separation anxiety).~   "
274886|NCT00000388|"~     This trial is a continuation of the Multimodal Treatment Study of Children with Attention~     Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of~     intervention-related effects as the MTA sample matures into mid-adolescence, including~     subsequent mental-health and school-related service utilization patterns as a function of MTA~     treatment experience (treatment assignment) and outcome (degree of treatment success at 14~     mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of~     long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive~     skills; peer relations) that may influence adolescent functioning (either independent of or~     through initial treatment assignment and/or 14-month treatment outcomes); and to compare how~     these predictors, mediators, and moderators are similar or dissimilar within the normal~     comparison group. Aim 3 is to track the patterns of risk and protective factors (including~     their mediation or moderation by initial treatment assignment and/or outcome) involved in~     early and subsequent stages of developing substance-related disorders and antisocial~     behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of~     treatment success on later academic performance, achievement, school conduct, tendency to~     drop out, and other adverse school outcomes.~      In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions:~     (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or~     (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14~     months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original~     MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This~     continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.~      A child may be eligible for this study if he/she:~      Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).~   "
274887|NCT00000387|"~     The purpose of this study is to test the effectiveness of a family-centered, community-based,~     self-management intervention (Self-Management Therapy) for adolescents with schizophrenia.~     The study will test the intervention's effectiveness in improving the adolescents' behavior,~     thinking, mood, and use of substances such as drugs and alcohol. The study also will look at~     the effects of the patient on the family.~      The intervention involves training in recognizing symptoms of schizophrenia and in stress~     management, problem-solving, and social skills. Parents and siblings are included to gain~     knowledge and skills to support the adolescents.~      The Self-Management Therapy intervention is administered in small multiple-family groups in~     12 sessions over 7-1/2 months. The effects of the intervention on the patient and his/her~     family are assessed prior to treatment, after 6 sessions, after 12 sessions, and in a~     follow-up visit 6 months after completion of sessions.~      A child may be eligible for this study if he/she:~      Is 15 to 19 years old and has been diagnosed with schizophrenia.~   "
274888|NCT00000386|"~     The purpose of this study is to evaluate a behavioral treatment program for children and~     adolescents with OCD and their families. Exposure and Response Prevention (ERP) behavior~     therapy, in which the patient is gradually exposed to the object or situation that causes~     anxiety and is taught to refrain from responding in a compulsive manner, is combined with~     family counseling (Family Treatment Program). This treatment will be compared to Relaxation~     Training (RT).~      OCD is a long-term, often disabling disorder that can cause significant family disruption.~     ERP is a promising treatment for children with OCD, and it is thought that family~     participation (through the Family Treatment Program) may be a helpful addition. RT is a~     common treatment for anxiety.~      Patients are assigned randomly (like tossing a coin) to receive either the ERP/Family~     Treatment Program or RT. Both treatments will be delivered over 12 90-minute outpatient~     sessions to youngsters and their families. All participants (patients and family members)~     will be assessed for treatment response each month during treatment, after treatment is~     finished, and then at 2 follow-up visits over the following 6 months.~      A child/adolescent may be eligible for this study if he/she:~      Has obsessive-compulsive disorder (OCD), is medication-free, and is 8 to 17 years old.~   "
274889|NCT00000385|"~     This study will examine the long-term effects of lithium used to treat children and~     adolescents with aggressive conduct disorder (severe aggression).~   "
274890|NCT00000384|"~     The purpose of this study is to compare 3 treatments for children with OCD: medication~     (sertraline, SER) alone vs OCD-specific therapy (Cognitive Behavior Therapy, CBT) vs~     medication plus therapy. Some patients will receive an inactive placebo (PBO) instead of~     medication and/or Educational Support (ES, non-psychological treatment) instead of therapy.~      One in 200 children suffer from OCD, but few receive appropriate treatment. Both CBT and~     medication seem to be effective, but their effectiveness, alone and in combination, has not~     been evaluated.~      There are 2 phases to this trial. In Phase I the child will receive 1 of the following 6~     treatments for 12 weeks: 1) SER alone; 2) pill PBO alone; 3) CBT alone; 4) SER plus CBT; 5)~     SER plus ES; 6) pill PBO plus ES. If the child responds to treatment, he/she will go on to~     Phase II in which the treatment will be slowly reduced, then stopped (discontinued), over~     time to test the treatment's durability. The child will be evaluated at Weeks 1, 4, 8, 12~     (Phase I treatment), and Weeks 16, 20, 24, and 28 (Phase II discontinuation) to see how~     effective and durable the treatment is in treating your child's OCD.~      A child may be eligible for this study if he/she:~      Has obsessive-compulsive disorder (OCD) and is 8 - 16 years old.~   "
274891|NCT00000383|"~     The purpose of this study is to compare the effectiveness of two psychological therapies used~     to treat PTSD in children who have recently been sexually abused: Trauma-Focused Cognitive~     Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT).~      Child sexual abuse is a common experience that has serious mental health consequences,~     including the development of PTSD and other abuse-related problems.~      All children will be assigned randomly (like tossing a coin) to receive either SAS-CBT or NST~     at each of two sites. In addition, the parents and the child will receive individual therapy~     for 12 weeks. The child will be monitored to evaluate his/her response to therapy.~     Assessments will take place before and just following treatment, and then 6 and 12 months~     post-treatment.~      A child may be eligible for this study if he/she:~      Has been sexually abused, is suffering from PTSD as a result of the abuse, and is 8 to 14~     years old.~   "
274892|NCT00000382|"~     The purpose of this study is to compare 2 approaches (interventions) to prevent child-abuse~     (maltreatment) in infants: Psychoeducational Home Visitation (PHV) vs Infant-Parent~     Psychotherapy (IPP). Non-maltreated infants and their mothers are studied as a comparison~     group.~      Twelve-month-old infants and their mothers are assigned randomly (like tossing a coin) to~     receive 1 of 3 types of intervention for 12 months: 1) Services normally available in the~     community when a family is reported for child maltreatment (Child Protective Services, CPS);~     2) CPS involvement plus weekly PHV; 3) CPS involvement plus weekly IPP. Intervention will be~     provided until the infant's second birthday. All mother-infant pairs (including comparison~     non-maltreated infants and their mothers) will be assessed when the infant is 12, 18, 24, 36,~     and 48 months old. Assessments will look at the effectiveness of the intervention in~     preventing child maltreatment, improving parenting, and reducing future abuse. The study will~     last for 3 years.~      Eligibility includes a mother and her 12-month-old child that has been abused by her (the~     mother) or the father. (Non-maltreated infants and their mothers also will be enrolled.)~   "
274893|NCT00000381|"~     The purpose of this study is to see if it is safe and effective to use fluoxetine to treat~     children and adolescents with Generalized Anxiety Disorder (GAD).~      Anxiety disorders are one of the most common psychiatric disorders in children and~     adolescents, and can cause disturbances in the child's school, social, and family lives.~     Having an anxiety disorder puts a child at risk for depression and drug abuse, and appears to~     continue into adulthood. There is very little information on anxiety medications for~     children.~      Children will be assigned randomly (like tossing a coin) to receive either fluoxetine or an~     inactive placebo for 12 weeks. Each child will be monitored for symptoms and side effects~     throughout the study. He/she will have blood tests at Weeks 4, 8, and 12 to measure drug~     levels in the blood. The study will last for 12 weeks.~      A child is eligible for this study if he/she:~      Is 8 to 17 years old and has anxiety disorder.~      A child will not be eligible for this study if he/she:~      Has current major depression, panic disorder, or obsessive-compulsive disorder, or abuses~     alcohol or drugs.~   "
274894|NCT00000380|"~     The purpose of this study is to examine the effects of giving growth hormone releasing~     hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen~     replacement therapy (ERT).~      Many older men and women complain of sleep disturbances. GHRH has been used successfully to~     treat sleep disorders in young men and may help older men and women.~      40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an~     inactive placebo.~      An individual may be eligible for this study if he/she is a healthy older man or woman with~     sleep disturbances, and is on estrogen replacement therapy (women).~   "
274895|NCT00000379|"~     The purpose of this study is to compare two treatments for post-traumatic stress disorder~     (PTSD): fluoxetine (an antidepressant) and Eye Movement Desensitization and Reprocessing~     (EMDR, a psychological treatment in which the patient is led through the memory of a~     traumatic experience in order to heal him/herself).~      There are a variety of therapies used to treat PTSD, but the effectiveness of medication~     alone vs an exposure treatment, such as EMDR, has not been tested.~      Patients will be assigned randomly (like tossing a coin) to one of three groups for 8 weeks~     of treatment. Group 1 will receive fluoxetine; Group 2 will receive EMDR; and Group 3 will~     receive inactive placebo. Patients will then stop treatment and have evaluations, including~     psychological tests, at the time treatment is stopped, 8 weeks later, and at 6 months.~      An individual may be eligible for this study if he/she:~      Has PTSD and is 18 to 65 years old.~   "
274896|NCT00000378|"~     The purpose of this study is to compare the safety and effectiveness of a select serotonin~     re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in~     outpatients over the age of 60 who have major depression.~      SSRIs are effective in the treatment of major depression. However, there is also evidence~     that SSRIs may be significantly less effective than TCAs for patients with late-life major~     depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more~     widely prescribed, it is important to determine which of these types of antidepressants works~     best to treat these patients.~      Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a~     TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of~     life. If a patient responds to treatment, he/she will participate in a 6-month continuation~     phase in which he/she will continue to receive the same medication.~      An individual may be eligible for this study if he/she:~      Has unipolar major depression (with some exceptions) and is over 60 years old.~   "
274897|NCT00000377|"~     The purpose of this study is to compare the effectiveness of two doses of nortriptyline in~     elderly patients whose depression returned after stopping treatment. Nortriptyline is an~     antidepressant.~      This study enrolls patients who were treated for depression in an earlier research study and~     whose depression has returned since stopping treatment. Patients are treated for 4 months to~     bring the depression under control. Patients are then assigned randomly (like tossing a coin)~     to receive either the full dose of nortriptyline or half the usual dose of nortriptyline.~     Patients continue taking nortriptyline for 2 years or until a major depression returns.~     Throughout the study, patients are monitored for symptoms of depression and other side~     effects.~   "
275014|NCT00000529|"~     To assess the impact of tamoxifen on development of breast cancer, coronary heart disease,~     and bone fractures. The National Cancer Institute initiated the prevention trial under its~     National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and~     Blood Institute provided support to obtain blood pressure and lipid measurements, and~     lipoprotein and selected coagulation factor measurements in a subsample.~   "
274898|NCT00000376|"~     To develop an effective combined cognitive therapy (CT) plus drug treatment for patients with~     drug-resistant depression (DRD) (i.e., depression that is refractory to medication). To~     develop a manual for combined treatment for DRD that integrates three existing forms of CT~     (CT for depression, CT for personality disorders, and CT for anxiety disorders), and that~     specifies interventions for combining CT and medication when two therapists (psychotherapist~     and pharmacotherapist) provide the treatment. To obtain outpatient, randomized control, pilot~     data on the clinical value of the combined CT plus drug treatment, using the standard~     antidepressant desipramine (DMI), to obtain effect sizes and to determine if the treatment~     merits further investigation in a clinical trial. To develop a therapist adherence measure~     for the combined treatment.~      Patients receive 1 of 2 treatments: CT plus DMI (n = 18) or DMI plus Clinical Management (n =~     12). The first 6 of the 18 CT plus DMI patients are treated in a pre-pilot phase before~     randomization begins. All treatments continue for 6 months. The major assessment battery is~     administered at intake, 3 months, 6 months, and follow-up 6 months later. All treatments are~     closely monitored via audiotapes and supervision for purposes of developing and refining the~     CT plus drug treatment. The audiotapes are also used for development of the adherence~     measure. The primary outcome measures are Hamilton Rating Scale for Depression scores, Beck~     Depression Inventory scores, percent of patients who achieve clinical remission of symptoms,~     and percent showing attrition from treatment. Compliance with the treatment regimens is also~     a targeted and measured outcome variable.~   "
274899|NCT00000375|"~     The purpose of this study is to compare the safety and effectiveness of two treatments to~     prevent relapses in seriously ill patients with major depressive disorder (MDD) who have~     responded to electroconvulsive therapy (ECT). Patients will either continue to receive ECT~     (continuation electroconvulsive therapy [C-ECT]), or they will be treated with antidepressant~     medications.~      ECT is a highly effective treatment for MDD; however, relapses are a major concern. To~     prevent relapse in patients who have responded to ECT, the common treatment is~     antidepressants as continuation therapy (following the initial therapy in order to continue~     treating the disorder). Relapses, however, can still occur even after antidepressant~     continuation therapy. This study will evaluate a potent antidepressant combination in order~     to prevent relapse. C-ECT is another option that needs to be tested.~      If the patient responds to the first round of ECT, he/she will be assigned randomly (like~     tossing a coin) to either continue receiving ECT or to receive an antidepressant combination~     of nortriptyline plus lithium (NOR-Li) for 6 months. The patient will have psychological~     tests before, shortly after, and 3 months after the first round of ECT, and at the end of the~     6-month continuation trial. Patients will be monitored for symptoms and side effects. All~     patients will have urine tests to test for drug abuse.~      An individual may be eligible for this study if he/she:~      Has major depressive disorder and responds positively to ECT treatment and is 18 to 80 years~     old.~   "
274900|NCT00000374|"~     This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and~     risperidone (Risperdal®) can help patients with first-episode schizophrenia.~   "
274901|NCT00000373|"~     The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum~     obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and~     involuntary body movements (tics).~      There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on~     type of OCD, determined by medical history and family member interviews. In Part 2, patients~     are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone,~     either haloperidol or an inactive placebo will be added to the FVX regimen; patients will~     take this drug combination for 4 weeks. Patients will be monitored throughout the trial.~   "
274902|NCT00000372|"~     The purpose of this study is to compare the effects of D-cycloserine and glycine for treating~     negative symptoms (such as loss of interest, loss of energy, loss of warmth, and loss of~     humor) which occur between phases of positive symptoms (marked by hallucinations, delusions,~     and thought confusions) in schizophrenics.~      Clozapine is currently the most effective treatment for negative symptoms of schizophrenia.~     Two other drugs, D-cycloserine and glycine, are being investigated as new treatments.~     D-cycloserine improves negative symptoms when added to some drugs, but may worsen these~     symptoms when given with clozapine. Glycine also improves negative symptoms and may still be~     able to improve these symptoms when given with clozapine. This study gives either~     D-cycloserine or glycine (or an inactive placebo) with clozapine to determine which is the~     best combination.~      Patients will be assigned to 1 of 3 groups. Group 1 will receive D-cycloserine plus~     clozapine. Group 2 will receive glycine plus clozapine. Group 3 will receive an inactive~     placebo plus clozapine. Patients will receive these medications for 8 weeks. Negative~     symptoms of schizophrenia will be monitored through the Scale for the Assessment of Negative~     Symptoms, Positive symptoms will be monitored through the Positive and Negative Syndrome~     Scale, and additionally subjects will complete the Brief Psychiatric Rating Scale and the~     Global Assessment Scale.~      An individual may be eligible for this study if he/she is 18 to 65 years old and has been~     diagnosed with schizophrenia.~   "
274909|NCT00000362|"~     The purpose of this study is to determine whether chin-down posture or use of a thickened~     liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in~     patients with Parkinson's disease and/or dementia. Liquid aspiration is the most common type~     of aspiration in older populations, especially those suffering from debilitation, dementia,~     and depression. Pneumonia may develop as a consequence of aspiration and is the fifth leading~     cause of death in the US among persons age 65 years and over. Current treatment involves~     either use of chin-down position with swallowing or use of thickened liquids in the diet,~     without any clear evidence supporting the use of one treatment over the other. This is a~     Phase III inpatient and/or outpatient study in which all participants will be randomly~     assigned to either the chin-down position or the thickened liquid treatment group based on~     swallowing function during a modified barium swallow. This study is scheduled to recruit~     patients for a three-year period; participation by each individual patient spans no more than~     three months after entry.~   "
275015|NCT00000528|"~     To determine if nonpharmacological interventions, including diet and lifestyle change, could~     prevent increases in arterial blood pressure leading to systemic hypertension.~   "
275016|NCT00000527|"~     To determine whether recurrent stenosis following carotid endarterectomy could be reduced by~     pre- and post-operative oral administration of platelet-inhibiting drugs.~   "
274903|NCT00000371|"~     To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment~     on negative symptoms, performance on neurocognitive tasks, and on markers for glutamatergic,~     dopaminergic and serotonergic function in serum and cerebrospinal fluid. To determine if~     negative symptoms and cognitive function improve over time, if these improvements~     meaningfully impact quality of life factors, if they correlate with markers of neuronal~     function, and if subpopulations can be identified according to response.~      Dysfunction of glutamatergic neuronal systems has recently been implicated in the~     pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the~     NMDA receptor can reproduce in normals the positive symptoms, negative symptoms, and~     cognitive deficits of schizophrenia. Furthermore, glutamatergic dysfunction may alter~     forebrain dopaminergic neuronal activity, a system central to the antipsychotic action of~     typical neuroleptics. It is believed that enhancing NMDA receptor function by systemic~     treatment with D-cycloserine, a partial agonist at the glycine modulatory site of the NMDA~     receptor, will reduce symptoms in schizophrenia.~      Sixty schizophrenic outpatients with prominent, primary negative symptoms are treated with~     antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month,~     fixed-dose trial. The primary outcome measure is the total score on the Scale for Assessment~     of Negative Symptoms (SANS). A neuropsychological battery, which emphasizes tests sensitive~     to prefrontal cortical function, is administered. Blood is obtained at several time points~     and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine, glutamate, HVA,~     and 5HIAA.~   "
274904|NCT00000370|"~     Social phobia is a very common and debilitating disorder, with public speaking anxiety being~     the most common fear. Psychologists have found that treating patients for their fear of~     public speaking, through cognitive-behavioral treatment (talk-based therapy) or exposure~     treatment (where participants participate in actual public speaking sessions), not only helps~     patients overcome this fear but also helps them overcome their more general social fears.~     However, little is known about how this change occurs during therapy. This study tries to~     identify the factors that contribute most to successful therapy.~      Patients are assigned randomly (like tossing a coin) to 1 of 3 groups. Group 1 will receive~     cognitive-behavioral treatment and Group 2 will receive exposure treatment. Group 3 will not~     receive treatment. Study leaders will monitor patient response to treatment through~     behavioral tests and assessments.~      An individual may be eligible for this study if he/she:~      Has social phobia with public speaking anxiety.~   "
274905|NCT00000369|"~     The purpose of this study is to see if adding a regimen of individualized psychotherapy can~     help bipolar I patients who are on lithium.~      While having a manic or depressed episode patients will be assigned randomly (like tossing a~     coin) to receive appropriate medication either with or without additional individual~     psychotherapy. If a patient responds well, he/she will again be assigned randomly to receive~     further preventative treatment in which medication will be managed either with continued~     medication clinic visits alone or with additional individual psychotherapy (the patient may~     not receive the same additional treatment this time). Patient response to treatment will be~     evaluated throughout the study. If manic/depressive symptoms return at any point during the~     study, the patient will be treated with appropriate medication and will continue the study.~      An individual may be eligible for this study if he/she:~      Has Bipolar I disorder, is experiencing a manic or depressed episode at the time of study~     entry, and is at least 18 years old.~   "
274906|NCT00000368|"~     Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of~     panic disorder (PD). The purpose of this study is 1) to determine whether nine months of~     maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of~     sustained improvement; and 2) to determine the acute acceptability and efficacy of medication~     therapy or continued CBT alone among patients who fail to respond sufficiently to an initial~     course of CBT alone.~      It has been found that patients with PD respond as well to CBT or medication alone as they do~     to a combination of the two. Since the combined treatments are expensive and CBT is~     associated with less risk of medical toxicity compared to medications, CBT alone will be used~     first.~      All patients will first receive CBT alone. If the patient responds to this therapy, the~     patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will~     continue to receive CBT (maintenance therapy) for 9 months. The other group of responders~     will not receive any further therapy. If a patient does not respond to CBT alone, he/she will~     be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other~     will continue to receive CBT for a longer period. The response to treatment will be evaluated~     to see which regimen works best to treat PD. The study will last approximately 3 years.~      An individual may be eligible for this study if he/she has panic disorder with no more than~     mild agoraphobia (fear of being in public places) and is at least 18 years old.~   "
274907|NCT00000367|"~     The purpose of this study is to design a program to prevent suicide in elderly patients by~     educating patients, their families, and physicians on depression and suicidal thoughts.~      A program to prevent suicide in elderly patients needs to be developed. Since elderly~     patients frequently have doctor's visits, it may be best to have a suicide prevention program~     based in the patient's doctor's office.~      When an older person visits a primary care physician, he/she will check for signs of~     depression, including thoughts of suicide. The doctor will speak to the patient about~     depression and how to recognize it. If the individual is diagnosed with depression, the~     doctor will offer treatment. During this study, the information the doctor collects will be~     used to evaluate the effectiveness of the program. The study will last for 2 years.~      Eligibility for this study is age of at least 60 years and diagnosis of depression.~     (Depression required for 920 of the 1200 patients; 280 patients should have no symptoms of~     depression.)~   "
274908|NCT00000363|"~     Acute otitis media is one of the most common diseases of childhood and is one of the major~     causes of hearing loss in children. Despite the availability of effective antibiotic therapy~     for otitis media, treatment failures, persistent effusions, and recurrences are common. This~     Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a~     corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes~     of patients with acute otitis media. This study is targeted to recruiting 200 infants (age~     less than one year); patient (and parent) participation is estimated to continue for one year~     after enrollment.~   "
274910|NCT00000361|"~     The purpose of this study is to determine whether prednisone, methotrexate, and~     cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing~     loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it~     is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to~     suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III,~     outpatient study. All study participants will be assigned to one of four different groups~     testing the experimental use of drugs. The study is scheduled to run for 18 months, with a~     minimum of 11 visits per participant.~   "
274911|NCT00000359|"~     The purpose of this study was to determine the relative short- and long-term efficacy of~     several physical treatment paradigms commonly employed for the treatment of benign paroxysmal~     positional vertigo (BPPV), including the canalith repositioning (Epley) maneuver, the~     liberatory (Semont) maneuver, the Brandt-Daroff exercises and nonspecific vestibular~     habituation exercises. These procedures involve exercises and head manipulations. Vertigo~     intensity and frequency, the presence/absence of slow-phase eye movements, the degree of~     dizziness handicap and acts of daily living (ADL) were assessed. The study also ascertained~     the effects of co-morbid conditions on the response to treatment. While BPPV is a common and~     significant public health problem that has been recognized for several decades, this is the~     first systematic study of the relative treatment efficacy of different physical treatment~     modalities for this disorder.~   "
274912|NCT00000180|"~     AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve~     function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting~     in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged~     animals and in animals with neurological deficits.~      This study was a double-blind placebo-controlled safety study that was designed to study~     whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two~     clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks;~     were tested for side effects and absorption; and underwent a battery of neuropsychological~     memory tests, including word and number recall tests.~   "
274913|NCT00000179|"~     Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and~     physical aggressiveness, irritability, wandering, and restlessness. These behaviors often~     make caring for patients at home very difficult. Trazodone and haldol are two of the most~     commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug~     approach, has been effective in reducing signs of agitation. Researchers have yet to compare~     the effectiveness of drug versus non drug therapy to treat agitation in AD patients and~     determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with~     funding from the National Institute on Aging, is conducting an agitation treatment program at~     21 sites in 16 States. This study will assess which of the above treatments is most~     effective.~   "
274914|NCT00000178|"~     This is a randomized placebo controlled, double blind study. Patients who meet eligibility~     criteria and decide to participate in the study will be randomly assigned to receive either~     drug treatment or a placebo. Neither the patients nor the participating investigators will~     know who is receiving the drugs and who is receiving the placebo. Participation involves 15~     outpatient clinic visits over a 68 week period. Patients take study medication at varying~     doses (the maximum dose is 20 mg daily), along with calcium and vitamin supplements.~   "
274915|NCT00000177|"~     Estrogen is a hormone that is dominant in the female reproductive system. In women, most~     estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into~     estrogen. Because this hormone also has many beneficial effects on brain cells, it currently~     is being studied as a treatment for Alzheimer's disease. The enzyme that forms the~     neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small~     clinical studies have demonstrated improvement in cognitive function and mood measures in~     women with Alzheimer's disease who take estrogen.~   "
274916|NCT00000176|"~     This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's~     disease in women with a family history of Alzheimer's disease.~   "
274917|NCT00000175|"~     This study is investigating the effects of hormone replacement therapy on memory, mental~     abilities and mood in older adults aged 65-90. During the nine month long study, men will~     take testosterone for three months and women will take estrogen for three months. At four~     points during the study (once every three months), participants will complete a test battery~     and have blood drawn.~   "
274918|NCT00000174|"~     This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled,~     36-month study comparing the length of time of progression from mild cognitive impairment~     (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs.~     placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a~     treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40~     countries for Alzheimer's disease to date, including all 15 member states of the European~     Union, New Zealand, Argentina, Brazil and Mexico.~      Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo.~     Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day)~     for the majority of the study. At every regular visit scheduled every three months, patients~     will be given basic efficacy and safety assessments. These assessments will include~     evaluation of adverse events, vital signs, activities of daily living, and clinical staging~     scales to determine if the subject may have converted to dementia.~   "
274919|NCT00000173|"~     The National Institute on Aging (NIA) is launching a nationwide treatment study targeting~     individuals with mild cognitive impairment (MCI), a condition characterized by a memory~     deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from~     both dementia and normal age-related changes in memory. Accurate and early evaluation and~     treatment of MCI individuals might prevent further cognitive decline, including development~     of Alzheimer's disease (AD).~      The Memory Impairment Study is the first such AD prevention clinical trial carried out by~     NIH, and will be conducted at 65-80 medical research institutions located in the United~     States and Canada. This study will test the usefulness of two drugs to slow or stop the~     conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an~     investigational agent approved by the Food and Drug Administration for another use. Vitamin E~     (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study~     to delay important dementia milestones, such as patients' institutionalization or progression~     to severe dementia, by about seven months.~   "
274920|NCT00000172|"~     Galantamine is an experimental drug being evaluated in the United States for the treatment of~     Alzheimer's disease. Results from previous clinical trials suggest that galantamine may~     improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for~     Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function~     communicate using a chemical called acetylcholine. Research has shown that deterioration of~     cells that produce acetylcholine in the brain affects thought processes. Galantamine is~     thought to work in two ways to increase the amount of acetylcholine available in the brain.~     It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic~     receptors in the brain to release more acetylcholine.~   "
274921|NCT00000171|"~     This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated~     with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of~     AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for~     caregivers. Alternatives are sorely needed to the currently available sleep medications that~     have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone~     secreted by the pineal gland. It has soporific effects with oral administration and is well~     tolerated. It enhances sleep in normal older people. Melatonin also may help sleep~     disturbances associated with AD; however, this remains to be proven.~   "
274922|NCT00000623|"~     The purpose of the TCRN is to accelerate research in the management of thalassemia,~     standardize existing treatments, and evaluate new ones in a network of clinical centers in~     North America. The emphasis will be on clinical trials that help identify optimal therapy.~     Therapeutic trials may involve investigational drugs, drugs already approved but not~     currently used, and drugs currently used.~   "
274923|NCT00000621|"~     To conduct feasibility studies on the use of retinoids in the treatment of emphysema.~     Specific objectives are to identify optimal patient populations, retinoids, doses, dosing~     schedules, routes of administration, and outcome measures preparatory to conducting a larger,~     controlled, clinical trial on the efficacy of retinoid therapy in the management of~     emphysema.~   "
274924|NCT00000620|"~     The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or~     cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic~     control, intensive blood pressure control, and multiple lipid management.~   "
274925|NCT00000619|"~     To compare the efficacy of Pulmonary Artery Catheterization (PAC)-directed treatment strategy~     to a non-invasive treatment strategy on morbidity and mortality in patients with severe,~     class IV New York Heart Association (NYHA) congestive heart failure. A secondary objective~     was to determine costs and resource utilization of PAC-directed treatment strategy compared~     to non-invasive treatment strategy.~   "
274926|NCT00000617|"~     To determine whether treatment with azithromycin decreases the rate of coronary heart disease~     events among patients with stable documented coronary artery disease.~   "
274927|NCT00000616|"~     To compare the effectiveness of advice versus two multicomponent lifestyle interventions to~     control blood pressure in participants with Stage 1 hypertension or higher than optimal blood~     pressure.~   "
274928|NCT00000615|"~     To develop and test interventions to prevent obesity by decreasing weight gain during the~     high-risk transitional period from pre-puberty to puberty in African-American girls who are~     at high risk for developing obesity.~   "
274929|NCT00000614|"~     A multicenter randomized, double blind placebo controlled trial to determine the efficacy of~     long-term, low dose warfarin in the secondary prevention of venous thromboembolism.~   "
274930|NCT00000613|"~     To determine the acceptability and benefits of use of a dietary supplement of the~     phytoestrogen, genistein, versus placebo on heart disease risk factors, bone density, and~     psychosocial outcomes in postmenopausal women.~   "
274931|NCT00000612|"~     To conduct a three-armed trial assessing the effect of soy phytoestrogens on menopausal~     complaints, plasma lipids and lipoproteins, vaginal bleeding and endometrial proliferation,~     and health related quality of life.~   "
274932|NCT00000611|"~     To address cardiovascular disease, cancer, and osteoporosis, the most common causes of death,~     disability, and impaired quality of life in postmenopausal women. The three major components~     of the WHI are: a randomized controlled clinical trial of hormone replacement therapy (HRT),~     dietary modification (DM), and calcium/vitamin D supplementation (CaD); an observational~     study (OS); and a community prevention study (CPS). On October 1, 1997, administration of the~     WHI was transferred to the NHLBI where it is conducted as a consortium effort led by the~     NHLBI in cooperation with the National Institute of Arthritis and Musculoskeletal and Skin~     Diseases (NIAMS), the National Cancer Institute (NCI), and the National Institute on Aging~     (NIA).~   "
274933|NCT00000610|"~     To determine whether early intravenous magnesium treatment of patients with suspected acute~     myocardial infarction reduces mortality.~   "
274934|NCT00000609|"~     To compare conventional treatment of congestive heart failure (CHF) with two experimental~     interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).~   "
274935|NCT00000608|"~     To compare the effects of three levels of dietary sodium and two patterns of diet (a control~     diet and an intervention diet high in fruits, vegetables, and low fat dairy products and low~     in fat) on blood pressure in individuals with higher than optimal blood pressure or with~     Stage 1 hypertension.. DASH - Sodium built on and extended the results of the NHLBI-initiated~     Dietary Approaches to Stop Hypertension (DASH) study.~   "
274936|NCT00000607|"~     To conduct a randomized, unblinded clinical trial comparing the left ventricular assist~     device (LVAD) with maximum medical management in patients with end-stage heart failure who~     were not candidates for heart transplantation.~   "
274937|NCT00000606|"~     To evaluate the long term efficacy, morbidity and mortality associated with medical therapy~     with lung volume reduction surgery (LVRS) as compared to medical therapy alone and to define~     patient selection criteria. The trial, conducted in conjunction with a patient registry, is~     supported by the NHLBI, the Centers for Medicare and Medicaid Services (CMS), and the Agency~     for Healthcare Research and Quality (AHRQ).~   "
274938|NCT00000605|"~     To determine if postmenopausal hormone replacement therapy in women following coronary bypass~     surgery would reduce the occurrence of graft occlusion and delay the development of graft~     atherosclerosis.~   "
274940|NCT00000603|"~     To evaluate if HLA-mismatched, unrelated-donor umbilical cord blood stem and progenitor cell~     units (UCBU) offered a clinically acceptable alternative to matched unrelated-donor~     allogeneic bone marrow for transplantation with 180-day disease free survival as the~     endpoint. HLA typing was performed using DNA-base high resolution methods to determine HLA~     alleles. Patients with true HLA 3/6 and 4/6 matches were evaluated. In addition, a separate~     study in adults addressed the problem of limited cell dose and engraftment failure. The study~     was not planned as a randomized comparative clinical trial. Instead, it is a phase II/III~     efficacy study.~   "
274941|NCT00000602|"~     To determine whether hydroxyurea prevents the onset of chronic end organ damage in young~     children with sickle cell anemia.~   "
274942|NCT00000601|"~     To determine if estrogen therapy in postmenopausal women with unstable angina reduces the~     incidence of ischemic episodes.~   "
274943|NCT00000600|"~     This study will evaluate the effects of vitamin E supplementation in retarding the~     progression of common carotid artery intima-media thickening in African Americans.~   "
274944|NCT00000599|"~     To determine whether combined therapy with the lipid lowering agents colestipol hydrochloride~     plus niacin would produce significant change in coronary, carotid, and femoral artery~     atherosclerosis and coronary bypass graft lesions as determined by angiography. Also, to~     determine possible correlations between lesion changes and plasma lipid and lipoprotein~     cholesterol levels and to explore interrelationships of atherosclerosis change in femoral,~     coronary, and carotid arteries.~   "
274945|NCT00000598|"~     To determine the effect in men and postmenopausal women with elevated LDL-cholesterol and low~     HDL-cholesterol of an exercise regimen with or without the National Cholesterol Education~     Program (NCEP) Step Two diet compared to usual care control group on HDL- and~     LDL-cholesterol.~   "
274946|NCT00000597|"~     To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with~     aplastic anemia and related bone marrow failure diseases.~   "
274947|NCT00000596|"~     To determine the effects of cyclophosphamide compared with prednisone, dapsone, or high-dose~     intermittent 'pulse' therapy with methylprednisolone in patients with idiopathic pulmonary~     fibrosis. Also, to evaluate the use of intermittent, short-term, high-dose intravenous~     corticosteroids in patients with sarcoidosis. There were actually four separate clinical~     trials.~   "
274948|NCT00000595|"~     To determine whether deferoxamine prevented the complications of transfusional iron overload.~   "
274949|NCT00000594|"~     To determine whether lowering of cholesterol with cholestyramine in a population with Type II~     hyperlipidemia led to a decreased rate of progression (a regression of coronary artery~     disease) as demonstrated by death, myocardial infarction, or progression of disease on~     angiography.~   "
274950|NCT00000593|"~     The purpose of the trial was to determine if transfusion of allogeneic blood to HIV-1~     infected persons led to immune activation and consequent induction of HIV-1 or /or~     Cytomegalovirus (CMV) replication, and whether this adversely affected clinical prognosis.~   "
274951|NCT00000592|"~     To reduce episodes of first time stroke by 75 percent in children with sickle cell anemia by~     the administration of prophylactic transfusion therapy.~   "
274952|NCT00000591|"~     To determine if a reduction in morbidity and mortality from acute and chronic graft versus~     host disease (GvHD) can be achieved through use of T-cell depletion techniques without a~     counterbalancing increase in relapse of leukemia in patients receiving an unrelated donor~     marrow transplant.~   "
274953|NCT00000590|"~     To determine if HIV hyperimmune globulin (HIVIG) given to HIV-positive pregnant women during~     the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV~     transmission. Conducted in collaboration with the National Institute of Child Health and~     Human Development and the National Institute of Allergy and Infectious Diseases. The trial~     was Pediatric ACTG Protocol 185.~   "
274954|NCT00000589|"~     To determine the best, clinically useful procedure to prevent or minimize platelet~     alloimmunization as a cause of refractoriness to platelet transfusion in patients undergoing~     marrow ablative chemotherapy for acute myelogenous leukemia.~   "
274955|NCT00000588|"~     To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl~     hydrazone (PIH) for the chronic treatment of iron overload.~   "
274956|NCT00000587|"~     To determine whether administration of human recombinant erythropoietin (REPO) improved or~     eliminated the anemia seen in human immunodeficiency virus (HIV) infected patients after~     therapy with zidovudine (ZDV).~   "
274957|NCT00000586|"~     To assess the efficacy and safety of orally administered hydroxyurea in the treatment of~     painful crises in patients with sickle cell anemia.~   "
274958|NCT00000585|"~     To determine whether the regular daily administration of oral penicillin would reduce the~     incidence of documented infection due to Streptococcus pneumoniae in children with sickle~     cell anemia.~   "
274959|NCT00000584|"~     To evaluate the capacity of intravenously administered cytomegalovirus (CMV)-immune globin~     (CMVIG) to immunize high risk premature infants against CMV infections.~   "
274960|NCT00000583|"~     To determine the efficacy of a hepatitis vaccine in preventing hepatitis B.~   "
274961|NCT00000582|"~     To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of~     hemophiliac patients who had inhibitors to Factor VIII.~   "
274962|NCT00000581|"~     To evaluate granulocyte transfusion therapy with respect to its prophylactic and therapeutic~     effectiveness to prevent and aid recovery from infection. The study trials were conducted~     simultaneously.~   "
274963|NCT00000580|"~     To evaluate whether hepatitis B immune globulin with a high level of antibody against the~     hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis~     B virus, the single most important route of hepatitis spread in the entire Third World.~   "
274964|NCT00000579|"~     The purposes of this study are to assess rapidly innovative treatment methods in patients~     with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS~     and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish~     and maintain the required infrastructure to perform multiple therapeutic trials that may~     involve investigational drugs, approved agents not currently used for treatment of ARDS, or~     treatments currently used but whose efficacy has not been well documented.~   "
274965|NCT00000578|"~     To conduct a collaborative program of research on asthma and pregnancy consisting of two~     studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate~     relationships between asthma severity and treatment programs and perinatal outcome, and the~     Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled~     beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both~     studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group~     of participating obstetric centers supported by the National Institute of Child Health and~     Human Development. Studies were co-funded by the NHLBI.~   "
274966|NCT00000577|"~     This study will establish a network of interactive asthma clinical research groups to~     evaluate current therapies, new therapies, and management strategies for adult asthma.~   "
274967|NCT00000576|"~     To test if inhaled glucocorticoids, early in the course of respiratory failure in premature~     infants, permit normal lung growth and differentiation, thus preventing development of~     bronchopulmonary dysplasia.~   "
274968|NCT00000575|"~     The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy~     compared to bronchodilator therapy on the course of asthma, particularly on lung function and~     bronchial hyperresponsiveness, and on physical and psychosocial growth and development.~   "
274969|NCT00000574|"~     To determine the effects of ibuprofen on mortality, development and reversal of shock, and~     adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients~     with serious infection.~   "
274970|NCT00000573|"~     To determine if enteral nutrition support (ENS) restores normal body weight and improves~     muscle strength, exercise performance, sensation of dyspnea, and quality of life in~     malnourished patients with chronic obstructive pulmonary disease.~   "
274971|NCT00000572|"~     To compare conventional therapy using low frequency positive pressure ventilation with~     extracorporeal CO2 removal for the treatment of adult respiratory distress syndrome (ARDS).~   "
274972|NCT00000571|"~     To test the effectiveness of ventilatory muscle rest (VMR) using home negative pressure~     ventilation (NPV) in improving exercise performance, alleviating dyspnea, and improving the~     quality of life in patients with severe chronic obstructive lung disease.~   "
274973|NCT00000570|"~     To determine if surfactant administration at birth in infants at high risk for respiratory~     distress syndrome (RDS) modified the clinical course of the syndrome.~   "
274974|NCT00000569|"~     To determine if participants with chronic obstructive pulmonary disease, who were assigned to~     inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of~     respiratory morbidity compared to participants assigned to placebo.~   "
274975|NCT00000568|"~     In the Lung Health Study I, to determine the effects of Special Care, compared to Usual Care,~     on rate of decline in pulmonary function in a group of cigarette smokers identified as having~     mild abnormalities in pulmonary function.~      In the Lung Health Study III, to determine the long-term effects of smoking cessation and~     continued smoking, on cardiopulmonary morbidity, mortality, and the rate of decline in the~     one second forced expiratory volume (FEV1) in men and women with early chronic obstructive~     lung disease who have been followed prospectively for 12 to 15 years.~   "
274976|NCT00000567|"~     To compare the efficacy and safety of high frequency ventilation (HFV) with that of standard,~     mechanical ventilation in premature infants of less than 2000 grams.~   "
274977|NCT00000566|"~     To evaluate the sensitivity and specificity of two major, widely used technologies,~     radionuclear imaging (ventilation-perfusion scanning) and pulmonary angiography, for the~     diagnosis of pulmonary embolism.~   "
274978|NCT00000565|"~     To evaluate the efficacy of long-term intermittent positive pressure breathing (IPPB)~     treatment when used as an adjunct to the overall care of ambulatory outpatients with chronic~     obstructive pulmonary disease. The evaluation compared the use of IPPB with use of a powered~     nebulizer.~   "
274979|NCT00000564|"~     To compare the efficacy of long-term use of nocturnal oxygen therapy (12 hours) with that of~     continuous, low-flow oxygen therapy (24 hours) in patients with chronic hypoxic lung disease.~   "
274980|NCT00000563|"~     To determine the effect of corticosteroids, administered 24 to 48 hours before parturition,~     on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the~     therapy has any adverse short- or long-term (up to 36 months) effects on the infant.~     Secondarily, to determine whether the therapy has any adverse short-term effects on the~     mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as~     well as total and cause-specific infant mortality rates differ between mothers who received~     antenatal steroids and those who received conventional medical care.~   "
274981|NCT00000562|"~     To evaluate indications for the use and efficacy of extracorporeal membrane oxygenators~     (ECMO's) for the support of patients with potentially reversible acute respiratory failure.~   "
274982|NCT00000561|"~     To determine if dual chamber rate-modulated pacing (DDDR) in patients with sick sinus~     syndrome is superior to single chamber pacing (VVIR) with respect to subsequent frequency of~     adverse clinical events such as stroke, quality of life and function, and cost effectiveness.~   "
274983|NCT00000560|"~     To determine if addition of a beta-blocker to standard therapy in Class III and Class IV~     heart failure patients reduced total mortality.~   "
274984|NCT00000559|"~     To determine the effects, in postmenopausal women, of hormone replacement therapy on~     progression/regression of coronary heart disease, as measured by quantitative angiography.~   "
274985|NCT00000558|"~     To determine whether the addition of angiotensin converting enzyme (ACE) inhibitor to~     standard therapy in patients with known coronary artery disease and preserved left~     ventricular function will prevent cardiovascular mortality and reduce the risk of myocardial~     infarction.~   "
274986|NCT00000557|"~     To evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary~     heart disease patients at high psychosocial risk.~   "
274987|NCT00000556|"~     To compare two standard treatment strategies for atrial fibrillation: ventricular rate~     control and anticoagulation vs. rhythm control and anticoagulation.~   "
274988|NCT00000555|"~     To assess whether hormonal replacement therapy and/or antioxidant treatment would stabilize~     or inhibit progression, and induce regression of coronary plaques. The mechanisms by which~     these treatments modified atherosclerosis in women were also explored.~   "
274989|NCT00000554|"~     To evaluate innovative diagnostic methods that will improve the diagnostic reliability of~     cardiovascular testing in evaluation of ischemic heart disease in women. Innovative~     approaches proposed include physiologic or functional measurements such as impaired~     metabolism, perfusion, or endothelial function as well as assessment of epicardial coronary~     arteries by angiography. Other objectives include developing safe, accurate, and cost~     effective diagnostic approaches for evaluating women with suspected ischemic heart disease,~     and determining the frequency of myocardial ischemia in the absence of significant epicardial~     coronary stenosis, as well as the frequency of non-ischemic or non-cardiac chest pain. A key~     aspect of the WISE study is to determine whether evidence of myocardial ischemia occurs in~     the absence of obstructive coronary disease.~   "
274990|NCT00000553|"~     To measure the effects of lipid-lowering drugs and/or antioxidant vitamins on progression or~     regression of coronary heart disease as measured by quantitative angiography in patients with~     low high density lipoprotein (HDL) cholesterol.~   "
274991|NCT00000552|"~     To test if early revascularization, primarily with angioplasty (PTCA) or bypass surgery~     (CABG), reduced all-cause in-hospital mortality from cardiogenic shock compared to~     conventional treatment, including thrombolysis.~   "
274992|NCT00000551|"~     To develop and evaluate the effectiveness of various intervention approaches, delivered in~     primary health-care settings, in increasing and maintaining habitual physical activity and~     cardiorespiratory fitness among sedentary men and women patients.~   "
274993|NCT00000550|"~     To evaluate the impact of community educational interventions on patient delay time from~     onset of symptoms and signs of an acute myocardial infarction (AMI) to arrival at a hospital~     Emergency Department (ED). Also, to study the impact of community educational interventions~     on use of Emergency Medical Services (EMS) and EDs, on thrombolytic therapy, and on AMI case~     fatality.~   "
274994|NCT00000549|"~     To determine if estrogen replacement therapy, with or without low dose progesterone, slows~     progression or induces regression of coronary atherosclerosis in postmenopausal women.~   "
274995|NCT00000548|"~     To test the hypothesis that low-dose inhaled nitric oxide administered to preterm infants who~     continue to require mechanical ventilation at 14 days of age will reduce the incidence of~     chronic lung disease.~   "
274996|NCT00000547|"~     To determine if the chronic administration of enalapril, an inhibitor of angiotensin~     converting enzyme (ACE), reduces progression of cardiac dysfunction in pediatric oncology~     patients who have received anthracyclines, and who are not currently on digoxin, diuretics,~     or vasodilators for heart failure.~   "
274997|NCT00000546|"~     To evaluate the effectiveness of stress reduction with Transcendental Meditation (TM) on left~     ventricular hypertrophy, left ventricular function, blood pressure, psychosocial stress and~     quality of life, and cardiovascular disease risk factors.~   "
274998|NCT00000545|"~     To implement a culturally appropriate school-based, multicenter, randomized trial that~     promotes healthful eating behaviors and increases physical activity to prevent obesity in~     pre-adolescent upper elementary American Indian students.~   "
274999|NCT00000544|"~     To test the effectiveness of dietary patterns in lowering blood pressure.~   "
275000|NCT00000543|"~     To determine of providing calcium supplementation to women with pre-existing hypertension~     reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of~     pre-eclampsia.~   "
275001|NCT00000542|"~     To determine if the combined incidence of nonfatal myocardial infarction and coronary heart~     disease death differs between diuretic-based and each of three alternative antihypertensive~     pharmacological treatments. Also, to determine, in a subset of this population, if lowering~     serum cholesterol with a HMG CoA reductase inhibitor in older adults reduces all-cause~     mortality compared to a control group receiving usual care. Conducted in conjunction with the~     Department of Veterans' Affairs.~   "
275002|NCT00000541|"~     To determine if supplements of vitamin C, vitamin E, beta-carotene, and B-vitamins (a~     combination of folic acid, vitamins B6 and B12) reduce risk of major cardiovascular events in~     high risk women with a prior history of atherosclerotic cardiovascular disease. The trial is~     a companion to the Women's Health Study (WHS), a primary prevention trial of vitamin E and~     aspirin in a low risk population of women.~   "
275003|NCT00000540|"~     To test the hypothesis that implantable cardioverter defibrillator (ICD) therapy will improve~     survival in coronary heart disease patients at high risk of death, especially arrhythmic~     death.~   "
275004|NCT00000539|"~     To evaluate, in asymptomatic and symptomatic participants with peripheral arterial disease,~     the feasibility of recruitment and adherence, efficacy and safety of HDL-C raising along with~     effective control of LDL-C levels, antioxidant therapy, antithrombotic therapy, and their~     combinations.~   "
275005|NCT00000538|"~     To evaluate the effects of carefully controlled diets on lipoproteins and clotting factors in~     different demographic groups.~   "
275006|NCT00000537|"~     To compare the effects of two stress reduction techniques, Transcendental Meditation (TM) and~     Progressive Muscle Relaxation (PMR), on the control of mild hypertension in elderly Blacks~     with hypertension.~   "
275007|NCT00000536|"~     To compare the effects of two levels of dietary sodium on blood pressure in Black men and~     women, and to determine what factors predict the degree of response.~   "
275008|NCT00000535|"~     To test the efficacy of weight loss and sodium restriction, alone and combined, in~     maintaining the normotensive state following withdrawal of antihypertensive medications in an~     elderly cohort. Conducted in collaboration with the National Institute on Aging.~   "
275009|NCT00000534|"~     To evaluate the efficacy of 2 grams per day of oral calcium supplementation in reducing the~     combined incidence of hypertensive disorders of pregnancy: pre-eclampsia, eclampsia, and the~     HELLP Syndrome (hypertension, thrombocytopenia, hemolysis, and abnormal liver function). The~     National Institute of Child Health and Human Development (NICHD) initiated the trial in 1991,~     with joint funding provided by the National Heart, Lung, and Blood Institute in fiscal years~     1992, 1993, and 1995.~   "
275010|NCT00000533|"~     To examine the impact of a monitoring and social support intervention upon survival of~     myocardial infarction patients.~   "
275017|NCT00000526|"~     To determine whether drug treatment of asymptomatic ventricular arrhythmias in~     post-myocardial infarction patients reduced the incidence of sudden cardiac death and total~     mortality.~   "
275028|NCT00000515|"~     To determine the effects on blood pressure of dietary intervention, restricting caloric~     intake to 600 calories per day for 16 weeks compared to a control diet of 1200 calories per~     day in obese hypertensives. Secondary aims included a study of psychological characteristics~     at baseline and during the weight loss and maintenance phases of the study.~   "
275029|NCT00000514|"~     The primary objective was to assess whether long-term administration of antihypertensive~     therapy to elderly subjects with isolated systolic hypertension reduced the combined~     incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the~     effect of long-term antihypertensive therapy on mortality from any cause in elderly people~     with isolated systolic hypertension; possible adverse effects of chronic use of~     antihypertensive drug treatment in this population; the effect of therapy on indices of~     quality-of-life; the natural history of isolated systolic hypertension in the placebo~     population.~   "
275030|NCT00000513|"~     The objective of the Trial of Antihypertensive Intervention Management (TAIM) was to~     determine the efficacy of dietary management and/or drug therapy, namely thiazide-like~     diuretics or a beta-blocker, in the control of mild hypertension. Additionally, the~     Continuation of the Trial of Antihypertensive Intervention Management (COTAIM) tested the~     effects of long-term weight reduction, and sodium/potassium changes added to weight~     reduction, as well as the original drug treatment, on the failure rate of blood pressure~     control.~   "
275031|NCT00000512|"~     To compare the effects of two intensive lipid-lowering regimens with conventional therapy on~     coronary atherosclerosis as assessed by arteriography.~   "
275032|NCT00000511|"~     To test the efficacy of omega-3 fatty acids in untreated mild hypertensives and magnesium,~     calcium, and potassium supplementation supplementation in non-hypertensives. These clinical~     trials were conducted in sequence over a four year period.~   "
275033|NCT00000510|"~     To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the~     dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty~     (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in~     reducing the incidence of coronary events and the severity and incidence of angina.~   "
275034|NCT00000509|"~     To examine the role of dietary sodium reduction with and without potassium supplementation in~     controlling blood pressure in hypertensive men.~   "
275035|NCT00000508|"~     To determine whether modification of risk factors altered the rate of progression of coronary~     artery disease in arteries with mild atherosclerosis and no mechanical intervention in~     patients who had coronary bypass surgery or percutaneous transluminal coronary angioplasty~     (PTCA).~   "
275036|NCT00000507|"~     To determine whether the administration of intravenous streptokinase (SK) early in the course~     of acute, transmural myocardial infarction would limit myocardial damage.~   "
275037|NCT00000506|"~     To determine the long-term efficacy of the combination therapy of phentermine and~     fenfluramine in conjunction with diet, exercise, and behavior modification in the treatment~     of simple, moderate obesity.~   "
275038|NCT00000505|"~     In TIMI I, to assess the relative thrombolytic activity and side effects of intravenous~     recombinant tissue-type plasminogen activator (rt-PA) versus intravenous streptokinase in~     patients with acute myocardial infarction. In TIMI II, to assess whether intravenous rt-PA~     given in the early hours of acute myocardial infarction should be followed by percutaneous~     transluminal coronary angioplasty (PTCA).~   "
275039|NCT00000504|"~     To compare the effectiveness of various drugs and drug combinations in suppressing complex~     ventricular arrhythmias, and to evaluate their safety.~   "
275040|NCT00000503|"~     To assess the effect of non-surgical reperfusion on infarct size in patients with acute~     myocardial infarction.~   "
275041|NCT00000502|"~     To assess the benefits of a new method of cardiopulmonary resuscitation, SC-V CPR~     (simultaneous compression and ventilation CPR) in terms of short and long-term survival and~     lessened cerebral dysfunction.~   "
275042|NCT00000501|"~     To test the feasibility and the efficacy of nutritional interventions in the primary~     prevention of hypertension in individuals predisposed to the development of hypertension;~     specifically, to test the hypothesis that reduction of weight and/or decreased sodium intake~     in obese individuals, or decreased sodium intake with or without increased potassium intake~     (in men and women, regardless of weight) would prevent the elevation of blood pressure and~     the incidence of hypertension.~   "
275043|NCT00000500|"~     To assess the effect on cardiovascular mortality of alternate-day consumption of 325~     milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day~     consumption of 50 milligrams of beta-carotene.~   "
275044|NCT00000499|"~     The SHEP Pilot Study had six objectives, each designed to develop and test critical~     components of a full scale trial directed at the health consequences of treating isolated~     systolic hypertension (ISH) in the elderly.~      l. To estimate and compare the yield of participants for randomization into a clinical trial~     from various community groups using various recruitment techniques.~      2. To estimate compliance with the visit schedule and to the prescribed double-blind~     regimens.~      3. To estimate and compare the effectiveness of specified antihypertensive medications in~     reducing the blood pressure.~      4. To estimate and compare the unwanted effects of specified antihypertensive medication in~     an elderly population.~      5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this~     population.~      6. To develop and test methods of ascertaining stroke and other disease endpoints.~   "
275045|NCT00000498|"~     To determine whether blood pressure could be controlled by nutritional-hygienic,~     non-pharmacologic means in hypertensives treated with drugs in the Hypertension Detection and~     Follow-up Trial (HDFP).~   "
275062|NCT00000481|"~     To evaluate the feasibility of recruiting women of different socioeconomic status and~     minority groups and to determine whether these women could achieve and maintain a modified~     fat-eating pattern. The full-scale trial sought to determine whether a low-fat diet could~     decrease the incidence of cancer and coronary heart disease in postmenopausal women. The~     National Heart, Lung, and Blood Institute contributed funds over a three-year period to~     measure lipids, lipoproteins, and other cardiovascular disease risk factors.~   "
275063|NCT00000480|"~     To determine the value of electrophysiologic (EP)-guided antiarrhythmic therapy in coronary~     heart disease patients at increased risk for sudden death. The study included a controlled~     clinical trial and a registry.~   "
275046|NCT00000497|"~     The primary objective of this multicenter cooperative clinical trial was to determine if~     dietary modification would enable drug controlled hypertensive patients to remain at 'goal~     blood pressures' after antihypertensive medication was withdrawn. The proposal made use of~     the HDFP hypertensive population who had five years of treatment for their hypertension.~     Additionally, the group of investigators proposed to determine if dietary treatment would~     permit patients not previously adequately controlled under the HDFP program to achieve~     normalization of blood pressure with a combination of dietary modification and drug~     treatment. The study also proposed to search for predictors (i.e., levels of hormonal agents~     such as plasma renin activity) of responsiveness to dietary manipulation among the~     hypertensive population as well as to identify psychological attributes that might be of~     importance in managing these patients.~   "
275047|NCT00000496|"~     To determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in~     reducing the angiographic progression of coronary artery disease over a five-year period and~     to test the predictive value of the platelet survival half-life in identifying patients with~     more rapid progression of coronary disease and development of its complications.~   "
275048|NCT00000495|"~     To determine whether improved nutrition to correct overweight and high sodium intake, and~     regular frequent moderate rhythmic exercise to improve cardio-pulmonary fitness and to slow~     heart rate could lower blood pressure and prevent development of hypertension in~     hypertension-prone individuals.~   "
275049|NCT00000494|"~     To evaluate the effects (up to one year of age) of indomethacin on the clinical course of~     patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the~     relative merits of indomethacin and surgery in infants with persistent respiratory distress~     who were not treated early with indomethacin. Two concurrent trials were performed.~   "
275050|NCT00000493|"~     To assess the ability of two separate therapeutic interventions, propranolol and~     hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary~     objective was to assess the influence of these therapies upon ventricular function and~     morbidity following myocardial infarction.~   "
275051|NCT00000492|"~     To determine whether the regular administration of the beta-blocker drug propranolol to~     people who had had at least one documented myocardial infarction would result in a~     significant reduction of mortality from all causes over the follow-up period. Eligible~     volunteer patients were recruited to participate in a double-blind clinical trial within 21~     days after the onset of the acute event. One-half of the patients were randomly assigned to a~     beta-blocking drug (propranolol) and one-half to a placebo. The trial also evaluated the~     effect of propranolol on incidences of coronary heart disease mortality, sudden cardiac~     death, and nonfatal myocardial infarction plus coronary heart disease mortality in persons~     with documented previous myocardial infarction.~   "
275052|NCT00000491|"~     To determine whether the daily administration of 1 gm of aspirin to individuals with a~     documented myocardial infarction would result in a significant reduction in mortality over a~     three year period.~   "
275053|NCT00000490|"~     To determine whether a profound reduction in serum cholesterol level, induced and maintained~     by partial ileal bypass, would prevent a second heart attack among men and women who had one~     myocardial infarction and whose blood cholesterol could not be reduced sufficiently by diet.~   "
275054|NCT00000489|"~     To compare coronary artery surgery with medical management in patients with coronary artery~     disease and to maintain a registry on all patients undergoing coronary arteriography, whether~     operatively or medically managed.~   "
275055|NCT00000488|"~     To determine whether reduction of cholesterol by drug therapy significantly lowered the~     atherosclerotic coronary heart disease rate in a group of hypercholesterolemic but otherwise~     healthy men.~      Total dollars spent on the CPPT from June 1973 were $142,250,000. We do not have a~     year-by-year breakdown.~   "
275056|NCT00000487|"~     To determine for a group of men at high risk of death from coronary heart disease whether a~     special intervention program to lower serum cholesterol, reduce blood pressure, and eliminate~     cigarette smoking would result in a significant reduction in mortality from coronary heart~     disease.~   "
275057|NCT00000486|"~     To compare the efficacy of medical or surgical (coronary artery bypass graft) therapy with~     regard to survival and quality of life in patients with unstable angina and requisite~     coronary anatomy as defined by angiography.~   "
275058|NCT00000485|"~     To determine the effectiveness of systematic, sustained, antihypertensive therapy in reducing~     morbidity and mortality from hypertension in a wide spectrum of persons with elevated blood~     pressure in 14 communities. During its course, the trial also obtained a direct measure of~     the prevalence, severity, and treatment status of representative white and black populations~     with high blood pressure in these 14 communities, and obtained an estimate of the extent of~     attainable reduction of complications of high blood pressure by an organized screening and~     blood pressure management program.~   "
275059|NCT00000484|"~     To determine whether the long-term treatment of essential hypertension without significant~     target organ disease materially influenced mortality and/or cardiovascular renal morbidity.~   "
275060|NCT00000483|"~     To determine whether there were any long term sequelae of the drugs used in the Coronary Drug~     Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).~   "
275061|NCT00000482|"~     To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic~     acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result~     in significant reduction in total mortality over a five year period. Secondarily, to~     determine whether the degree to which these drugs changed serum lipids was correlated with~     any effect on mortality and morbidity rates; to gain further information on the long-term~     prognosis of myocardial infarction (by studying the control group as intensively as the~     treatment group); to acquire further experience and knowledge concerning the techniques and~     methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of~     aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.~   "
275064|NCT00000479|"~     The purpose of this study is to evaluate the effects of low-dose aspirin and vitamin E in~     primary prevention of cardiovascular disease and cancer in apparently healthy women.~   "
275065|NCT00000478|"~     To assess the feasibility of and test the methodology for a full-scale clinical trial of~     therapies for asymptomatic cardiac ischemia.~   "
275071|NCT00000472|"~     The Thrombolysis in Myocardial Ischemia Trial (TIMI III) focused on unstable angina and~     non-Q-wave myocardial infarction. The trial was designed to determine by coronary~     arteriography the incidence of coronary thrombi in these conditions and the response of these~     thrombi to tissue-type plasminogen activator (t-PA) in TIMI IIIA and the effects of~     thrombolytic therapy and of an early invasive strategy on clinical outcome in TIMI IIIB.~     There was also a registry with two components. A roster enumerated all patients with unstable~     angina or non-Q-wave myocardial infarction enrolled at cooperating hospitals. From the~     roster, a study population of 1,893 subjects was selected and followed prospectively for the~     year to determine incidence of death or myocardial infarction.~   "
275072|NCT00000471|"~     To assess long-term effects of a strict lifestyle change program on lipids, blood pressure,~     myocardial perfusion, and coronary atherosclerosis.~   "
275073|NCT00000470|"~     To compare the influence of two surgical anesthetic techniques, hypothermia with circulatory~     arrest or hypothermia with low-flow bypass perfusion, on neurologic functioning in infants~     undergoing heart surgery.~   "
275074|NCT00000469|"~     To determine whether warfarin or lovastatin alone or in combination retarded the progression~     of atherosclerotic plaques in the carotid arteries of high risk individuals with asymptomatic~     carotid stenosis. Also, to determine if a full scale trial was feasible.~   "
275075|NCT00000468|"~     To determine the practicality, benefit, and safety of paramedic administration of~     thrombolytic therapy for acute myocardial infarction. The feasibility of paramedics correctly~     identifying candidates for thrombolytic therapy following myocardial infarction was assessed~     in Phase I. In Phase II, pre-hospital thrombolytic therapy was compared with in-hospital~     thrombolytic therapy.~   "
275076|NCT00000467|"~     To assess the effectiveness of school-based risk reduction interventions involving three~     components: environmental changes related to food consumption, physical activity, and smoking~     policy in the school; classroom curriculum; and family and home-based education.~   "
275077|NCT00000466|"~     To assess the effects of various postmenopausal estrogen replacement therapies on selected~     cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood~     pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in~     collaboration with the National Institute of Child Health and Human Development, the National~     Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of~     Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended~     follow-up is for 3 years focusing on endometrium and breast evaluation.~   "
275078|NCT00000465|"~     To compare the efficacy of coronary artery bypass graft (CABG) surgery with percutaneous~     transluminal coronary angioplasty (PTCA) in patients with multiple vessel coronary heart~     disease.~   "
275079|NCT00000464|"~     To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals~     who had survived one episode of out-of-hospital cardiac arrest.~   "
275080|NCT00000463|"~     To determine the relative effectiveness of moderate versus more aggressive lipid lowering,~     and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass~     graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous~     vein coronary bypass grafts placed 1 to 11 years previously.~   "
275081|NCT00000462|"~     To assess the relative long-term safety and efficacy of percutaneous transluminal coronary~     angioplasty (PTCA) and coronary artery bypass graft (CABG) surgery in patients with~     multivessel disease and severe angina or ischemia who required revascularization and had~     coronary anatomy suitable for either procedure.~   "
275082|NCT00000461|"~     To determine by sequential coronary arteriography whether a lipid-lowering diet with and~     without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic~     patients. Also, to test whether fish oil supplements could improve human coronary~     atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing~     drugs in patients with coronary heart disease and normal cholesterol levels. At least three~     clinical trials were conducted.~   "
275083|NCT00000460|"~     To determine the effects of high or low intensity long-term exercise conditioning in patients~     with coronary artery disease.~   "
275084|NCT00000459|"~     To assess the feasibility, acceptability, efficacy, and safety of dietary intervention in~     free-living children ages 8-10 with elevated low density lipoprotein cholesterol levels.~   "
275085|NCT00004500|"~     OBJECTIVES:~      Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL)~     in the treatment of meconium aspiration syndrome (MAS) in newborn infants.~   "
275086|NCT00004498|"~     OBJECTIVES:~      I. Determine the safety, feasibility, and potential efficacy of intravascular adenoviral~     vector mediated gene transfer in the liver in adults with partial ornithine transcarbamylase~     deficiency.~   "
275087|NCT00004497|"~     OBJECTIVES:~      I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary~     pulmonary hypertension.~   "
275088|NCT00004496|"~     OBJECTIVES: I. Determine the maximum tolerated dose and safety of alpha-melanocyte~     stimulating hormone (alpha-MSH) in patients with acute renal failure.~      II. Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute~     renal failure after renal transplantation.~      III. Determine the safety and pharmacokinetics of alpha-MSH in patients with established~     ischemic acute renal failure.~      IV. Determine the effect of alpha-MSH on interleukin-10 pharmacokinetics.~   "
275089|NCT00004495|"~     OBJECTIVES: I. Compare the efficacy of two doses of folic acid in normalizing plasma total~     homocysteine concentration in patients with end stage renal disease receiving regular~     hemodialysis therapy resulting in hyperhomocysteinemia.~      II. Determine the requirement of co-supplementation with extra pyridoxine (vitamin B6) and~     cyanocobalamin (vitamin B12) daily in these patients.~      III. Assess the safety and tolerability of this therapy in these patients.~   "
275090|NCT00004494|"~     OBJECTIVES:~      I. Determine the maximum tolerated dose of vasoactive intestinal peptide in patients with~     acute respiratory distress syndrome.~      II. Evaluate the safety and pharmacodynamic activity of this peptide in these patients.~   "
275167|NCT00004381|"~     OBJECTIVES: I. Compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct~     Coombs' test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate~     dehydrogenase deficiency in infants living in Greece.~      II. Assess the safety of tin mesoporphyrin in high-risk newborns.~   "
275091|NCT00004493|"~     OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients~     with congenital lactic acidemia.~      II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute~     episodes of acidotic illness, improving linear growth, improving neurological or~     developmental function, or slowing neurological or developmental deterioration in these~     patients.~   "
275092|NCT00004492|"~     OBJECTIVES:~      I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the~     severity of anemia and the rate of hemolysis in patients with sickle cell anemia.~   "
275093|NCT00004490|"~     OBJECTIVES:~      I. Compare the safety of sodium dichloroacetate (DCA) vs placebo in children with congenital~     lactic acidosis.~      II. Determine the quality of life of these patients.~      III. Determine the pharmacokinetics and metabolic fate of DCA over the course of drug~     administration in these patients.~   "
275094|NCT00004489|"~     OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone~     metabolism in patients with cystic fibrosis.~      II. Assess the safety and efficacy of this treatment regimen in improving osteoporosis in~     this patient population.~   "
275095|NCT00004488|"~     OBJECTIVES:~      I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone~     density and focal bone lesions) in patients with Gaucher's disease.~   "
275096|NCT00004487|"~     OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in~     pediatric patients with vesicoureteral reflux.~      II. Determine the long term efficacy of this treatment regimen in this patient population.~      III. Evaluate the short and long term avoidance of surgery or antibiotic therapy after this~     treatment regimen in this patient population.~      IV. Estimate the risk:benefit ratio of this treatment regimen in these patients.~   "
275097|NCT00004486|"~     OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global~     severity and compulsive dimensions of children and adolescents with autism.~      II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this~     patient population.~      III. Compare the baseline compulsive severity and treatment outcome in these patients.~   "
275098|NCT00004485|"~     RATIONALE: Sickle cell disease is an inherited disorder in which abnormal, crescent-shaped~     red blood cells interfere with the ability of the blood to carry oxygen through the body and~     can cause severe pain, stroke, and organ damage. Bone marrow transplantation, is a procedure~     in which the soft, sponge-like tissue in the center of bones producing white blood cells, red~     blood cells, and platelets is replaced by bone marrow from a another person. Bone marrow~     transplantation may be an effective treatment in relieving the symptoms of sickle cell~     disease.~      PURPOSE: Phase I/II trial to study the effectiveness of bone marrow transplantation in~     treating children who have sickle cell disease.~   "
275099|NCT00004483|"~     OBJECTIVES:~      I. Define the growth rates and clinical course of NF2-related tumors in patients with~     neurofibromatosis type 2. Associate growth rate with physical function.~   "
275100|NCT00004482|"~     OBJECTIVES:~      I. Assess the effect of immunosuppression with muromonab-CD3, cyclosporine,~     methylprednisolone, and prednisone versus standard care in terms of death, heart~     transplantation, or left ventricular assistive device placement in patients with giant cell~     myocarditis.~      II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in~     these arms.~      III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of~     treatment in these arms.~   "
275101|NCT00004481|"~     OBJECTIVES:~      I. Identify the genetic defect and fine map the gene that causes sitosterolemia.~   "
275102|NCT00004480|"~     OBJECTIVES:~      I. Determine the optimal dose of botulinum toxin necessary to decrease sweating in patients~     with primary hyperhidrosis.~   "
275103|NCT00004479|"~     OBJECTIVES:~      Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing~     neurally mediated syncope.~   "
275104|NCT00004478|"~     Please note that the continuation study can be found at~     http://clinicaltrials.gov/show/NCT00633880.~      RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from~     a lying down to a standing position or after eating a meal. It causes one to feel dizzy,~     light headed, and weak. Neurogenic hypotension is caused by a problem in the part of the~     nervous system that controls such functions as heart rate and blood pressure. Droxidopa, a~     drug that may increase blood pressure, may be an effective treatment for neurogenic~     hypotension.~      PURPOSE: Clinical trial to study the effectiveness of droxidopa in treating patients who have~     neurogenic hypotension.~   "
275105|NCT00004475|"~     The purpose of this study is to establish linkage in families with hereditary pancreatitis~     (HP) to the cationic trypsinogen gene or other, as yet unknown, HP gene(s).~   "
275106|NCT00004474|"~     OBJECTIVES:~      I. Compare outcome, including graft failure, graft versus host disease, and survival of~     HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with~     or without antithymocyte globulin as a conditioning regimen.~   "
275107|NCT00004471|"~     OBJECTIVES:~      Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells~     lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated~     gene transfer.~   "
275108|NCT00004468|"~     OBJECTIVES: I. Evaluate the long term safety and efficacy of orally administered calcitriol~     in patients with at least 5% of their body covered with psoriasis.~      II. Evaluate the long term safety and efficacy of topically administered calcitriol in~     patients with at least 5% of their body covered with psoriasis.~      III. Compare the topical calcitriol treatment to the oral calcitriol treatment in these~     patients.~   "
275109|NCT00004467|"~     OBJECTIVES:~      I. Determine the safety and efficacy of a short course (72 hours) of intravenous~     acetylcysteine in patients with acute liver failure for whom no antidote or specific~     treatment is available.~   "
275110|NCT00004466|"~     OBJECTIVES:~      I. Determine the effect of atorvastatin on the plasma levels of lipids, Lp(a), and~     apoproteins for treating hyperlipidemia in children with nephrotic syndrome in whom~     proteinuria and hyperlipidemia persist after other appropriate measures to treat their~     primary disease have been exhausted.~      II. Determine the safety and tolerability of atorvastatin in these patients.~      III. Provide preliminary data for a future investigation into the potential effect that~     lowering cholesterol levels may have on the rate of progression of renal insufficiency in~     such patients.~   "
275111|NCT00004465|"~     OBJECTIVES: I. Determine the effect of SYNSORB Pk therapy on mortality and frequency of~     severe extrarenal complications observed in children with acute stage E. coli-associated~     hemolytic uremic syndrome.~      II. Determine the effect of SYNSORB Pk therapy on the need for the duration of dialysis in~     these patients.~      III. Determine the effect of SYNSORB Pk therapy on the recovery of renal function and~     resolution of urinary abnormalities in these patients.~   "
275112|NCT00004464|"~     OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose~     cyclophosphamide in patients with severe aplastic anemia.~      II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide~     shortens the time to recovery in these patients.~      III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal~     hemoglobinuria.~   "
275113|NCT00004458|"~     OBJECTIVES:~      I. Compare the developmental course (language acquisition, diagnostic stability, predictors~     of outcome, and restricted interests and behaviors) of childhood disintegrative disorder~     versus autism and non-autistic developmental delays.~      II. Collect data on molecular genetics of proband and family members.~   "
275114|NCT00004457|"~     OBJECTIVES:~      I. Determine specific clinical features, molecular abnormalities, and laboratory-based~     biological markers of free radical stress that are associated with amyotrophic lateral~     sclerosis and influence disease severity.~   "
275115|NCT00004454|"~     OBJECTIVES: I. Evaluate the safety and feasibility of treating mucopolysaccharidosis II (mild~     Hunter syndrome) by lymphocyte gene therapy.~      II. Determine the levels of iduronate-2-sulfatase enzyme in these patients attained by~     infusing increasing doses of lymphocytes transduced with a retroviral vector designed for~     insertion and expression of this iduronate-2-sulfatase gene (L2SN).~      III. Determine the duration of survival of these transduced cells in these patients.~      IV. Determine whether monthly infusion of L2SN-transduced lymphocytes accomplishes metabolic~     correction (as measured by glycosaminoglycan excretion), decrease in liver or spleen volume,~     any therapeutic effect upon cardiac and pulmonary dysfunction, or any other effects from~     treatment.~   "
275116|NCT00004451|"~     This study will determine whether glucose facilitates memory in healthy elderly people and~     those with Parkinson's disease.~   "
275117|NCT00004450|"~     OBJECTIVES: I. Evaluate the efficacy of interferon beta and thalidomide in male patients with~     adrenoleukodystrophy who show evidence of brain inflammatory response and are receiving~     concurrent glyceryl trierucate and glyceryl trioleate (Lorenzo's oil).~      II. Evaluate the progress of the disease and possible side effects of the medication in these~     patients.~   "
275118|NCT00004449|"~     OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in~     the home or neighborhood compared with at home, individualized, parent training in preschool~     aged children with autism.~      II. Identify intake measures that predict differences in outcome between subjects in the~     experimental group.~   "
275119|NCT00004448|"~     OBJECTIVES:~      Evaluate the efficacy of alternate day prednisone versus daily fish oil supplements in~     slowing or preventing the decline in renal function in children, adolescents, and young~     adults with moderate to severe immunoglobulin A nephropathy.~   "
275120|NCT00004446|"~     The purpose of this study is to:~      1) Determine the effects of fluoxetine in the treatment of depersonalization disorder, 2)~     Assess the durability of treatment response in these patients, 3) Assess the improvement in~     psychiatric disability in these patients, and 4) Assess the effects of comorbid Axis I~     disorders (depression, social phobia, panic/anxiety, obsessive-compulsive disorder) and Axis~     II personality disorders on treatment outcome in these patients.~   "
275121|NCT00004445|"~     OBJECTIVES:~      I. Establish the procedures for implementing and assessing the clinical utility of functional~     neuromuscular stimulation using an implanted eight-channel standing and transfer system in~     patients with incomplete tetraplegia or paraplegia.~      II. Develop and apply quantitative functional evaluations of system performance in these~     patients.~      III. Perform long term follow up and monitor system use outside of the laboratory.~   "
275122|NCT00004444|"~     OBJECTIVES: I. Compare the pharmacokinetics and early bactericidal activity of paromomycin~     (aminosidine) vs streptomycin for the treatment of uncomplicated pulmonary tuberculosis.~      II. Compare the tolerability of these two drugs in these patients. III. Establish the~     relationships between achieved serum concentration, minimal inhibitory concentration, and~     early bactericidal activity of paromomycin and streptomycin.~   "
275123|NCT00004443|"~     OBJECTIVES: I. Assess the safety and efficacy of NTBC in children with tyrosinemia I.~      II. Evaluate the effects of NTBC on survival, rate of neurologic crises, improvement in renal~     tubular damage, reduction in the need for liver transplantation, and reduction in the~     development of hepatocarcinoma in these patients.~   "
275124|NCT00004442|"~     OBJECTIVES: I. Determine the effectiveness of oral bile acid therapy with cholic acid,~     chenodeoxycholic acid, and ursodeoxycholic acid in patients with peroxisomal disorders~     involving impaired primary bile acid synthesis.~      II. Determine whether suppression of synthesis of atypical bile acids and enrichment of bile~     acid pool with this regimen is effective in treating this patient population and improving~     quality of life.~   "
275125|NCT00004441|"~     OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to~     achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease.~      II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects~     on biliary bile acid composition and metabolism, serum biochemistries, fat absorption, and~     fat-soluble vitamin status in these patients.~   "
275126|NCT00004440|"~     OBJECTIVES:~      I. Determine the effect of different doses of ibuprofen on neutrophil (polymorphonuclear~     leukocyte; PMN) delivery to a mucosal surface (the oral mucosa) in patients with cystic~     fibrosis and healthy controls.~      II. Determine the duration of effect (and possible rebound effect) of ibuprofen on PMN~     delivery to a mucosal surface in these patients.~   "
275127|NCT00004438|"~     RATIONALE: Hypogonadotropism is an abnormal condition caused by decreased production of~     gonadotropins, a group of hormones that stimulate the parts of the reproductive system that~     produce and release eggs from the ovaries or sperm from the testicles. Leuprolide may~     stimulate the production of gonadotropins and be effective in increasing testosterone in men~     and inducing ovulation in women.~      PURPOSE: Clinical trial to study the effectiveness of leuprolide in treating adults who have~     hypogonadotropism.~   "
275128|NCT00004437|"~     OBJECTIVES: I. Define the tonotopocity of multichannel brain stem stimulation and use this~     information to better program the auditory brain stem implant for an individual.~      II. Optimize device fitting by combining monopolar and bipolar stimulation, and individual~     psychoacoustic channels for each patient, to increase the number of usable information~     channels for each patient and reduce or eliminate undesirable side effects.~      III. Evaluate performance and learning effects using optimized fitting procedures.~   "
275129|NCT00004436|"~     OBJECTIVES: I. Evaluate the clinical efficacy of leuprolide, a gonadotropin-releasing hormone~     agonist (GnRHa), in treating infants with vision-endangering or large, disfiguring~     hemangiomas.~      II. Assess the impact of GnRHa on growth and development during infancy. III. Assess the~     safety of GnHRa in these patients.~   "
275130|NCT00004433|"~     OBJECTIVES:~      I. Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the~     dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette~     syndrome (GTS).~      II. Compare tolerability and safety of pergolide in these patients to standard neuroleptic~     therapy via naturalist assessment after 3-6 months of treatment using matched historical~     controls on neuroleptics.~      III. Determine efficacy of pergolide for tic control in these patients.~   "
275131|NCT00004431|"~     OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal~     neuralgia.~      II. Evaluate the safety and tolerance of L-baclofen in these patients.~   "
275132|NCT00004430|"~     OBJECTIVES:~      I. Demonstrate the safety and efficacy of dihematoporphyrin derivative (DHP) in laser~     photodynamic therapy (PDT) in patients with corneal neovascularization.~      II. Document the histopathologic mechanism of action in selected patients undergoing~     penetrating keratoplasty following PDT therapy for corneal neovascularization.~      III. Facilitate FDA product approval of DHP as a photosensitizing agent for laser treatment~     in these patients.~      IV. Explore the use of this photosensitizer for ocular and cutaneous basal cell and squamous~     cell carcinoma.~   "
275133|NCT00004429|"~     OBJECTIVES:~      I. Assess the clinical safety and long term effects of recombinant human growth hormone on a~     defined range of nutritional indices in malnourished chronic hemodialysis and continuous~     ambulatory peritoneal dialysis patients.~   "
275134|NCT00004428|"~     OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients~     with mild cystic fibrosis.~      II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.~   "
275135|NCT00004426|"~     RATIONALE: The body's response to one injection of leuprolide may provide more information~     than the standard test for gonadotropin deficiency in determining whether the cause of~     gonadotropin deficiency is related to the hypothalamus or the pituitary gland.~      PURPOSE: Randomized double-blinded clinical trial to study the effectiveness of leuprolide in~     determining the cause of gonadotropin deficiency.~   "
275136|NCT00004424|"~     OBJECTIVES:~      I. Assess the degree of amnesia afforded by study sedatives relative to the patient's~     intensive care unit experiences.~      II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional~     sedative regimen consisting of continuous infusion fentanyl and midazolam.~      III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to~     combination drug therapy in acutely ill, mechanically ventilated pediatric patients.~   "
275137|NCT00004423|"~     OBJECTIVES:~      I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's~     disease of the small bowel.~   "
275138|NCT00004422|"~     OBJECTIVES:~      Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the~     treatment of severe pertussis in children.~   "
275139|NCT00004421|"~     RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are~     persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided~     by a small, battery operated implant placed under the skin of the chest that delivers low~     voltage electrical pulses through a wire under the skin that is connected to a specific area~     of the brain. Deep brain stimulation may help lessen the symptoms of dystonia.~      PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating~     patients who have dystonia.~   "
275140|NCT00004420|"~     OBJECTIVES:~      I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood~     arthritis.~   "
275141|NCT00004419|"~     OBJECTIVES: I. Determine the efficacy and toxic effects of recombinant human insulin-like~     growth factor I (rhIGF-I) on carbohydrate tolerance, insulin action, insulin secretion,~     hyperandrogenism, and hyperlipidemia in patients with severe insulin resistance who have~     failed other therapies.~      II. Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary~     abnormalities in this patient population.~      III. Determine the effect of rhIGF-I on insulin clearance, the regulation of insulin-like~     growth factor binding protein 1, the regulation of sex hormone binding globulin, and~     hypothalamic pituitary gonadal axis in this patient population.~   "
275142|NCT00004418|"~     OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl~     trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy.~      II. Compare the frequency and severity of neurological disability of study patients with~     untreated historical controls.~   "
275143|NCT00004416|"~     OBJECTIVES: I. Compare the efficacy of two doses of botulinum toxin in the treatment of~     achalasia.~      II. Compare the safety of these two doses in these patients.~   "
275144|NCT00004415|"~     OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can~     maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia~     who are not candidates for phrenic nerve pacing alone.~      II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and~     diagram activation in these patients.~   "
275145|NCT00004414|"~     OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely~     premature newborns on long term parenteral nutrition and given either sincalide or placebo.~      II. Compare morbidity and mortality rates in this patient population. III. Evaluate~     ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the~     administration of sincalide or placebo to assess the development of biliary sludge and~     biliary stone formation.~   "
275220|NCT00004312|"~     OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with~     cystinosis treated with cysteamine.~      II. Track and monitor all patients including renal transplant, dialysis and post renal~     transplants.~   "
275146|NCT00004412|"~     OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate~     in terms of healing rate in patients with refractory sickle cell ulcers.~      II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion~     or inhibition of wound healing in these patients.~      III. Determine whether the regimen used in this study is appropriate for testing in pivotal~     trials.~   "
275147|NCT00004410|"~     OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have~     a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration~     of cholestasis compared to the nontreatment arm.~      II. Determine the significance of lower birth weight and longer duration of total parenteral~     nutrition (TPN) on increasing risk of TPN associated cholestasis and increasing benefit from~     TUDCA therapy.~      III. Determine whether TUDCA therapy leads to significant reduction in the appearance of~     biliary tract sludge and/or stone formation in these infants.~      IV. Determine whether TUDCA therapy leads to reduced urinary excretion of potentially~     hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration~     of TPN.~   "
275148|NCT00004409|"~     OBJECTIVES:~      Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of~     motion, and grip strength in patients with residual Dupuytren's disease.~   "
275149|NCT00004408|"~     OBJECTIVES: I. Assess the efficacy of poloxamer 188 in reducing the duration of painful~     vaso-occlusive crisis in patients with sickle cell disease.~      II. Assess the effect of poloxamer 188 on duration and intensity of pain, total analgesic~     use, and length of hospitalization of these patients.~   "
275150|NCT00004407|"~     OBJECTIVES: I. Determine the effect of intravenous immunoglobulin on recovery time of~     patients with proximal diabetic neuropathy.~      II. Determine whether rate of response is dose dependent in these patients.~   "
275151|NCT00004406|"~     OBJECTIVES:~      I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men~     with idiopathic osteoporosis.~   "
275152|NCT00004404|"~     OBJECTIVES:~      Determine the effectiveness of the combined use of clotrimazole and hydroxyurea on a specific~     panel of red cell characteristics in patients with sickle cell syndromes.~   "
275153|NCT00004403|"~     OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the~     severity and duration of epilepsy due to neurocysticercosis.~      II. Determine the effect of a short course of albendazole on Taenia solium cysts present in~     the brain.~      III. Determine the natural regression of cerebral T. solium cysts in patients given placebo~     and their response to treatment at the end of the study.~   "
275154|NCT00004402|"~     OBJECTIVES: I. Compare the rate of treatment failure in osteopetrosis patients receiving~     interferon gamma in combination with calcitriol to the rate of treatment failure in patients~     receiving calcitriol alone.~      II. Compare the number of adverse events or clinical manifestations of disease progression~     occurring in these patients.~      III. Assess the effects of interferon gamma on hematopoiesis, cranial nerve function, and~     rate of infection in these patients.~   "
275155|NCT00004401|"~     OBJECTIVES: I. Determine the safety of human botulism immune globulin (BIG) in patients with~     infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and anaphylaxis).~      II. Assess the efficacy of BIG in these patients by monitoring disease severity, incidence of~     complications (respiratory arrest, aspiration, pneumonia, etc.), and length of hospital stay.~   "
275156|NCT00004400|"~     OBJECTIVES: I. Determine whether physiologic testosterone replacement can increase fat-free~     mass, therefore contributing to weight maintenance, improved muscle function, and quality of~     life in HIV-infected women.~      II. Examine the mechanism of testosterone-induced increase in fat-free mass.~   "
275157|NCT00004399|"~     OBJECTIVES:~      I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of~     eclamptic seizures in patients with severe preeclampsia.~   "
275158|NCT00004398|"~     OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria~     attacks who are also treated with a standard course of heme arginate.~      II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these~     patients.~   "
275159|NCT00004397|"~     OBJECTIVES: I. Evaluate the effectiveness of tin mesoporphyrin in reducing the number of heme~     infusions needed to prevent acute attacks of porphyria.~      II. Evaluate the safety and tolerability of tin mesoporphyrin in these patients.~   "
275160|NCT00004396|"~     OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin~     mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute~     intermittent porphyria.~      II. Evaluate and compare the safety and tolerability of these treatment regimens in this~     patient population.~   "
275161|NCT00004393|"~     OBJECTIVES: I. Conduct a randomized, double blind, placebo controlled, parallel study of the~     atypical neuroleptic risperidone (RIS) in the treatment of children and adults with moderate~     to severe Tourette Syndrome.~      II. Evaluate further the safety of RIS in this population.~   "
275162|NCT00004392|"~     OBJECTIVES: I. Assess and compare the incidence and severity of cardiorespiratory events~     documented by home monitoring in infants at increased epidemiological risk for sudden infant~     death syndrome (SIDS).~      II. Determine the antecedent medical, demographic, physiologic, and behavioral~     characteristics that predict the incidence of cardiorespiratory events documented by home~     monitoring.~   "
275163|NCT00004390|"~     OBJECTIVES: I. Determine whether opioid (morphine) treatment results in better management of~     pain than treatment with tricyclic antidepressant (nortriptyline).~      II. Assess the effects the two treatments have on affective and cognitive functions.~      III. Determine whether the presence of psychiatric comorbidity, particularly depression, can~     predict the outcome of the two treatments.~   "
275164|NCT00004387|"~     OBJECTIVES:~      I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's~     disease.~   "
275165|NCT00004386|"~     OBJECTIVES:~      Evaluate the safety and feasibility of administering recombinant adenovirus containing the~     ornithine transcarbamylase gene to adults with partial ornithine transcarbamylase deficiency.~   "
275166|NCT00004382|"~     OBJECTIVES: I. Compare the effectiveness of a single dose of tin mesoporphyrin and special~     blue light phototherapy in controlling hyperbilirubinemia in premature newborns in Greece.~      II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy~     without adverse effects in these newborns.~   "
275168|NCT00004380|"~     OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's~     phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic~     sclerosis (scleroderma).~      II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and~     cultured from skin biopsies.~   "
275169|NCT00004378|"~     OBJECTIVES: I. Ascertain whether stem cell transplantation (SCT) is an effective method by~     which missing or dysfunctional enzymes can be replaced in patients with various inborn errors~     of metabolism.~      II. Determine whether clinical manifestations of the specific disease may be arrested or~     reversed by this treatment.~   "
275170|NCT00004376|"~     OBJECTIVES:~      I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children~     and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit~     hyperactivity disorder.~   "
275171|NCT00004375|"~     OBJECTIVES:~      I. Evaluate the mechanisms of ultraviolet A-1 light therapy in patients with systemic lupus~     erythematosus and normal controls.~   "
275172|NCT00004374|"~     OBJECTIVES: I. Analyze prospectively the course of amyloid deposition in patients with~     primary, secondary, myeloma-associated, and hereditary amyloidosis.~      II. Determine abnormalities of humoral and delayed-type hypersensitivity in these patients.~      III. Identify prognostic factors in hereditary amyloidosis and develop tests for genetic~     defects associated with systemic amyloidosis.~      IV. Diagnose familial amyloidotic polyneuropathy (FAP) prior to symptom onset. V. Validate~     the correlation of low serum prealbumin and retinol binding protein levels with amyloidosis~     in patients with FAP.~   "
275173|NCT00004373|"~     OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication~     behavior in anxious patients with varying histories of using other drugs.~      II. Establish outpatient methods for the study of self-medication and drug reinforcement in~     patients vulnerable to prescription drug abuse or dependence.~      III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of~     vulnerability in these patients.~      IV. Identify personality, attitudinal, or other variables that might predict different~     patterns of self-medication.~      V. Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.~   "
275174|NCT00004368|"~     OBJECTIVES:~      I. Investigate the efficacy and safety of colchicine therapy in improving hepatic function~     and reducing hepatic fibrosis (scarring) in children with hepatic cirrhosis.~   "
275175|NCT00004367|"~     OBJECTIVES: I. Determine whether the prevalence of abnormalities on clinical vestibular~     (balance) tests is higher in panic disorder with agoraphobia than in uncomplicated panic~     disorder and nonpanic anxiety disorder.~      II. Determine whether the prevalence of abnormalities on audiological tests of cochlear or~     brainstem function is elevated in panic disorder without agoraphobia or nonpanic anxiety~     disorder.~      III. Determine whether symptom patterns can be identified that are indicative of vestibular~     abnormalities in panic disorder.~      IV. Determine whether vestibular dysfunction can be induced by psychosomatic mechanisms.~   "
275176|NCT00004366|"~     OBJECTIVES:~      I. Evaluate whether vestibular rehabilitation training is of value in reducing anxiety~     symptoms in patients with panic disorder with or without agoraphobia who have vestibular~     dysfunction as identified by clinical vestibular tests.~   "
275177|NCT00004365|"~     OBJECTIVES: I. Assess pituitary size and anatomic configuration by magnetic resonance imaging~     (MRI) in 4 affected dwarfs in the province of Sindh, Pakistan.~      II. Evaluate ultradian growth hormone (GH) secretory patterns in 4 affected dwarfs.~   "
275178|NCT00004364|"~     OBJECTIVES:~      I. Define the phenotype and genotype of previously unrecognized types of familial diabetes~     insipidus (FDI) in kindreds with atypical or novel forms of FDI.~   "
275179|NCT00004363|"~     OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II~     (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by~     directing the production of an abnormal preprohormone.~      II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys~     magnocellular neurons because it cannot be folded and processed efficiently.~   "
275180|NCT00004361|"~     OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with~     repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function~     after induced hypocalcemia.~      II. Determine the relationship of parathyroid hormone secretion to microdeletions in the same~     region of chromosome 22q11 as found in patients with DiGeorge anomaly.~   "
275181|NCT00004360|"~     OBJECTIVES:~      I. Determine the relationship between genotype variations and clinical phenotype in patients~     with congenital nephrogenic diabetes insipidus.~   "
275182|NCT00004359|"~     OBJECTIVES: I. Evaluate immunomodulation with extracorporeal photochemotherapy (ECP) in~     patients with epidermolysis bullosa acquisita.~      II. Investigate the effect of ECP on lymphocyte activity.~   "
275183|NCT00004358|"~     OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of~     calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact~     parathyroid hormone levels in patients with tumoral calcinosis.~      II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether~     hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus.~      IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone~     metabolism in osteopenic patients with tumoral calcinosis.~   "
275184|NCT00004357|"~     Juvenile dermatomyositis (JDM) is a connective tissue disease that causes skin rash and weak~     muscles in children. The purpose of this study is to measure the absorption of oral~     prednisolone and intravenous (IV) methylprednisolone and to determine levels of disease~     activity indicators in the blood. These levels will be compared to see if there are patterns~     specific to active and less active JDM.~   "
275185|NCT00004356|"~     OBJECTIVES: I. Determine basal and postmethionine plasma homocysteine in patients with~     premature vascular disease, cystathionine beta-synthase (CBS) or methylenetitrahydrofolate~     reductase (MTHFR) deficiency, and in obligate heterozygotes for CBS or MTHFR.~      II. Determine whole-body homocysteine metabolic rates with isotopically-labeled methionine.~   "
275240|NCT00004268|"~     OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine~     in patients with neurogenic orthostatic hypotension.~      II. Assess the quality of life in these patients with this treatment regimen.~   "
275186|NCT00004354|"~     OBJECTIVES: I. Determine the prevalence of glucocorticoid-remediable aldosteronism (GRA) in~     various hypertensive populations and screen at risk members of GRA pedigrees.~      II. Investigate other factors regulating blood pressure in GRA (environmental, genetically~     determined factors).~      III. Investigate renal and hormonal mechanisms regulating potassium homeostasis in GRA.~      IV. Describe clinical phenotype of GRA patients. V. Prospectively screen GRA-affected~     patients with MRI angiography for intracranial aneurysm.~   "
275187|NCT00004353|"~     OBJECTIVES: I. Study the metabolism of pyruvate and related problems in patients with lactic~     acidemia.~      II. Define the nature of the metabolic defect.~   "
275188|NCT00004351|"~     OBJECTIVES: I. Investigate phenotype and genotype correlations in patients with Smith-Magenis~     syndrome (SMS) associated with del(17p11.2).~      II. Clinically evaluate SMS patients with unusual deletions or duplication of proximal 17p.~      III. Clinically evaluate patients with Williams syndrome with molecular characterization of~     7q11.23.~      IV. Perform clinical studies of Prader-Willi, Angelman, DiGeorge, and Shprintzen syndrome~     patients with unique molecular findings in 15q11q13 or 22q11.2.~      V. Perform genotype and phenotype correlations in Prader-Willi patients, particularly those~     with loss of expression of only some of the imprinted transcripts in 15q11-q13.~      VI. Evaluate putative Angelman syndrome patients who do not have classic large deletion,~     uniparental disomy, or imprinting mutations, and perform molecular studies of the Angelman~     gene, UBE3A, and identify mutations of this gene.~      VII. Investigate phenotype and genotype correlations in patients with terminal deletions of~     chromosome 1p.~   "
275189|NCT00004350|"~     OBJECTIVES:~      I. Classify renal tubular defects using clinical and biochemical findings in patients with~     Fanconi syndrome and cystinosis.~   "
275190|NCT00004348|"~     OBJECTIVES:~      I. Characterize inheritance patterns of mutations in patients with beta-oxidation disorders.~   "
275191|NCT00004347|"~     OBJECTIVES: I. Examine the intestinal absorption of dietary cholesterol in patients with~     Smith-Lemli-Opitz syndrome.~      II. Measure the effect of dietary cholesterol on plasma sterol composition. III. Quantify~     basal cholesterol synthesis, turnover of cholesterol and 7-dehydrocholesterol, and the~     effects of dietary cholesterol on these parameters.~      IV. Identify fecal bile acid excretion quantitatively and qualitatively in these patients.~      V. Compare the incorporation of deuterated water into plasma cholesterol,~     7-dehydrocholesterol, and other intermediates, and assess the effect of dietary cholesterol~     on this incorporation.~   "
275192|NCT00004346|"~     OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the~     turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis~     before and after a cholesterol- and cholestanol-free diet.~      II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of~     individual sterols and bile acids in these patients before and after lovastatin and~     chenodeoxycholic acid.~   "
275193|NCT00004345|"~     OBJECTIVES: I. Examine the concentration of docosahexanoic acid (DHA) and other n-3 fatty~     acids in plasma, erythrocyte, and adipose tissue in patients with various forms of retinitis~     pigmentosa and Usher syndrome.~      II. Determine the synthesis and catabolism of DHA from linolenic acid in these patients.~      III. Determine the synthesis, absorption, and catabolism of DHA under different dietary~     conditions in these patients.~   "
275194|NCT00004344|"~     OBJECTIVES:~      Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had~     precocious puberty as boys.~   "
275195|NCT00004343|"~     OBJECTIVES:~      I. Determine whether Cushing's syndrome and stress-induced pseudo-Cushing's syndrome can be~     differentiated by evaluating endogenous corticotropin-releasing hormone activity.~   "
275196|NCT00004342|"~     OBJECTIVES: I. Document the clinical course of severe chronic neutropenia (SCN).~      II. Monitor and assess long term safety of primary treatment in SCN patients in the United~     States, Canada, Europe, and Australia.~      III. Study the incidence and outcome of adverse events such as osteoporosis, splenomegaly,~     cytogenetic abnormalities, myelodysplastic syndrome, and leukemia.~      IV. Evaluate growth and development and hematologic parameters. V. Monitor for clinically~     significant changes in primary treatment response over time.~      VI. Establish a physician network to increase the understanding of SCN. VII. Establish a~     demographic database to allow for future research.~   "
275197|NCT00004341|"~     OBJECTIVES: I. Identify the molecular defects responsible for primary immunodeficiency~     disorders.~      II. Explore the mutations within each syndrome to better understand the genetics of these~     disorders.~      III. Study the function of the Wiskott-Aldrich syndrome proteins (WASP). IV. Design methods~     to identify carriers and for prenatal diagnosis. V. Explore new avenues for therapy.~   "
275198|NCT00004340|"~     OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human~     growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy.~      II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes~     in bone formation.~      III. Characterize the response to GH in cancellous bone and in growth plate cartilage in~     patients with secondary hyperparathyroidism during calcitriol therapy.~   "
275199|NCT00004339|"~     OBJECTIVES:~      Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with~     trientine therapy as initial treatment in patients with Wilson disease presenting~     neurologically.~   "
275200|NCT00004338|"~     OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200~     patients with Wilson disease.~      II. Establish further the role of zinc in the prophylactic treatment of presymptomatic~     patients by increasing the current cohort from 80 to at least 100 patients.~      III. Establish further the role of zinc therapy in pregnant patients with Wilson disease.~      IV. Establish further the role of zinc therapy in children with Wilson disease.~   "
275201|NCT00004336|"~     OBJECTIVES:~      I. Determine the mode of inheritance of nonsyndromal Mondini inner ear dysplasia, an inner~     ear malformation causing deafness, vestibular dysfunction, and recurrent meningitis.~   "
275202|NCT00004335|"~     OBJECTIVES: I. Evaluate the sleep-entrained patterns of gonadotropin-releasing hormone (GnRH)~     and sex steroid secretion in normal and hypogonadal children.~      II. Examine the acute effects of sex steroids on the sleep-entrained patterns of GnRH~     secretion in pubertal children and normal adults, either by stimulation of endogenous~     production with pulsatile injection or by intravenous infusion of GnRH.~      III. Examine the role of endogenous opioids by means of opioid receptor blockade in the sex~     steroid regulation of GnRH secretion in pubertal children and normal adults.~   "
275203|NCT00004334|"~     OBJECTIVES: I. Study the relationship between dysregulation of the~     hypothalamic-pituitary-adrenal (HPA) axis and disorders of mood, vegetative function, and~     cognition in patients with Cushing's disease.~      II. Identify subgroups of patients with Cushing's disease who differ in the presence and~     severity of the depressive syndrome, and uncover HPA axis dysregulation differences among~     them using corticotropin-releasing hormone, metyrapone, and dexamethasone challenge testing.~   "
275204|NCT00004333|"~     OBJECTIVES:~      Assess whether 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (NTBC) at 0.6 mg/kg~     per day prevents liver failure in at least 1 patient with tyrosinemia type I.~   "
275205|NCT00004332|"~     OBJECTIVES: I. Determine whether release of endogenous growth hormone (GH)-releasing hormone~     is involved in GH responses to clonidine, pyridostigmine, levodopa, arginine, GH-releasing~     peptide, insulin-induced hypoglycemia, and exercise in patients with acromegaly.~      II. Determine whether endogenous GH-releasing hormone influences the maintenance of GH~     hypersecretion.~   "
275206|NCT00004331|"~     OBJECTIVES: I. Characterize enzyme defects in patients with known or suspected porphyria and~     their family members.~      II. Determine whether selected patients are eligible for other porphyria research protocols.~      III. Provide blood, urine, and fecal samples from well characterized patients and their~     family members to investigators studying the nature of specific mutations in genes for heme~     biosynthetic pathway enzymes.~   "
275207|NCT00004330|"~     OBJECTIVES:~      Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and~     effective for the prevention of cyclic attacks of acute porphyria in women.~   "
275208|NCT00004329|"~     OBJECTIVES: I. Determine the response in plasma norepinephrine concentration and plasma~     glycerol to the agonist (clonidine) and the antagonist (yohimbine) of the alpha-2 adrenergic~     receptor in 6 patients with regional lipoatrophy and in 6 controls.~      II. Determine the full sequence of the alpha-2 adrenergic receptor structural gene in genomic~     DNA from peripheral blood leukocytes.~   "
275209|NCT00004328|"~     OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic~     state in a patient with pseudohypoaldosteronism.~      II. Determine the effect of extracellular fluid volume and serum potassium manipulations on~     exercise tolerance, cardiac function, and endurance.~      III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.~   "
275210|NCT00004327|"~     OBJECTIVES:~      I. Evaluate the efficacy of octreotide, a somatostatin octapeptide analog, in decreasing~     gastrointestinal bleeding in patients with hormone-refractory hereditary hemorrhagic~     telangiectasia or senile ectasia.~   "
275211|NCT00004326|"~     OBJECTIVES: I. Evaluate whether chronic hypercortisolemia is specifically toxic to~     hippocampal cells and causes structural reduction of hippocampal volume in patients with~     Cushing's syndrome.~      II. Determine whether reduced hippocampal volume is associated with specific memory~     dysfunction.~      III. Examine the relationships of adrenal androgen to hippocampal volume and memory~     dysfunction.~      IV. Examine the reversibility of hippocampal structural changes and cognitive dysfunction~     after cortisol levels are normalized.~   "
275212|NCT00004325|"~     OBJECTIVES: I. Investigate the pathobiology of Tourette syndrome and related disorders by~     measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients~     with Tourette syndrome, obsessive compulsive disorder, and/or chronic tics.~      II. Determine the pattern of familial aggregation of Tourette syndrome and obsessive~     compulsive disorder by systematic assessment of all first-degree family members of patients~     selected for cerebrospinal fluid studies.~      III. Establish the neurochemical and neuropeptide profile associated with the range of~     expression of the putative Tourette gene expression in adult and adolescent patients.~   "
275213|NCT00004324|"~     OBJECTIVES: I. Characterize the natural history, associated features, and severity of~     symptoms of obsessive compulsive disorder and Tourette syndrome in children and adolescents.~      II. Identify factors that influence the clinical course and prognosis of these patients.~   "
275214|NCT00004323|"~     OBJECTIVES: I. Evaluate the efficacy of related, HLA-identical bone marrow transplantation~     following cyclophosphamide (CTX) and antithymocyte globulin in patients with aplastic anemia.~      II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following~     CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.~   "
275215|NCT00004317|"~     RATIONALE: Congenital toxoplasmosis is an infection caused by the parasitic organism~     Toxoplasma gondii, and it may be passed from an infected mother to her unborn child. The~     mother may have mild symptoms or no symptoms; the fetus, however, may experience damage to~     the eyes, nervous system, skin, and ears. The newborn may have a low birth weight, enlarged~     liver and spleen, jaundice, anemia, petechiae, and eye damage. Giving the antiparasitic drugs~     pyrimethamine and sulfadiazine is standard treatment for congenital toxoplasmosis, but it is~     not yet known which regimen of pyrimethamine is most effective for the disease.~      PURPOSE: Randomized phase IV trial to determine which regimen of pyrimethamine is most~     effective when combined with sulfadiazine and leucovorin in treating patients who have~     congenital toxoplasmosis.~   "
275216|NCT00004316|"~     OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with~     interstitial cystitis.~      II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in~     patients with vulvar vestibulitis.~      III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar~     skin.~      IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and~     prostaglandin.~   "
275217|NCT00004315|"~     OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol~     (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated~     liver disease or chronic cholestatic liver disease.~      II. Compare the differences in pruritus, weight gain, and liver function for both treatments.~   "
275218|NCT00004314|"~     OBJECTIVES: I. Determine the effects of aminoimidazole carboxamide riboside (AICAR) on~     hematologic manifestations of Lesch-Nyhan disease.~      II. Assess the behavioral and neurological benefits of AICAR in patients with Lesch-Nyhan~     disease.~      III. Examine the effect of AICAR on purine production.~   "
275219|NCT00004313|"~     OBJECTIVES:~      I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone,~     for patients with primary adrenal insufficiency (Addison's disease).~   "
275221|NCT00004311|"~     OBJECTIVES: I. Evaluate insulin resistance in thin and obese hyperandrogenic women with~     polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans~     syndrome and in thin and obese controls, using an estimation of tissue sensitivity to~     insulin.~      II. Evaluate the effect of androgen suppression with leuprolide acetate and spironolactone on~     insulin secretion and resistance.~   "
275222|NCT00004310|"~     OBJECTIVES:~      I. Evaluate the efficacy of intravenous versus oral pulse loading of clomipramine (CMI)~     followed by a 12-week course of maintenance therapy in patients with obsessive compulsive~     disorder.~   "
275223|NCT00004307|"~     RATIONALE: The urea cycle is the process in which nitrogen is removed from the blood and~     converted into urea, a waste product found in urine . Urea cycle disorders are inherited~     disorders caused by the lack of an enzyme that removes ammonia from the bloodstream. Gene~     therapy is treatment given to change a gene so that it functions normally. Studying the~     treatment and metabolism of patients with urea cycle disorders may be helpful in developing~     new treatments for these disorders.~      PURPOSE: Two-part clinical trial to study the treatment and metabolism of patients who have~     urea cycle disorders.~   "
275224|NCT00004306|"~     OBJECTIVES: I. Clinically evaluate members from families with a dominantly inherited ataxia~     and collect blood, skin and muscle samples for detailed molecular studies.~      II. Perform detailed clinical evaluations on patients with recessively inherited ataxias.~   "
275225|NCT00004305|"~     OBJECTIVES: I. Determine whether allelic differences associated with the fourth component of~     complement, type-1 complement receptor expressed on erythrocytes, and Fc receptor FcgRIII~     contribute to the pathogenesis of IgA glomerulonephritis (IgA-N).~      II. Compare genetic anomalies of these key components in immune complex processing and~     clearance between juvenile vs adult onset IgA-N vs normal controls.~   "
275226|NCT00004300|"~     OBJECTIVES: I. Determine differences between persons with repetitive behavior disorders and~     matched controls on measures of motor control relevant to basal ganglia pathophysiology.~      II. Determine the efficacy of bromocriptine, a dopamine agonist, in the treatment of~     stereotyped behavior and related behavior disorders.~      III. Determine the efficacy of sertraline hydrochloride, a selective serotonin uptake~     inhibitor, in the treatment of repetitive behavior disorders.~      IV. Identify behavioral, environmental, and biological variables with differential drug~     treatment response.~   "
275227|NCT00004297|"~     OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and~     complications of diazepam and lorazepam given intravenously as prehospital therapy to~     patients in status epilepticus.~      II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the~     subsequent emergency department admission.~      III. Establish whether prehospital therapy alters hospital management of these patients and~     ultimately affects patient outcome.~   "
275228|NCT00004296|"~     OBJECTIVES: I. Determine the prevalence of nontuberculous mycobacteria in sputum cultures~     from patients with cystic fibrosis.~      II. Compare the clinical course of patients with negative versus positive cultures.~   "
275229|NCT00004294|"~     OBJECTIVES: I. Transfer the human glucocerebrosidase (GC) gene into peripheral blood stem~     cells (PBSC) obtained from patients with type I Gaucher disease using a retroviral vector.~      II. Transplant the autologous transduced PBSC in these patients. III. Measure the carriage~     and expression of the transferred gene and its duration in peripheral blood leukocytes.~      IV. Assess the clinical effects of transplanting genetically corrected PBSC.~   "
275230|NCT00004293|"~     OBJECTIVES:~      I. Evaluate the efficacy and toxicity of glucocerebrosidase enzyme therapy in patients with~     Gaucher disease.~   "
275231|NCT00004288|"~     OBJECTIVES:~      I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men~     with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and~     physiotherapy.~   "
275232|NCT00004287|"~     OBJECTIVES:~      I. Assess the safety and feasibility of gene transfer with the third generation adenovirus~     H5.001CBCFTR in patients with cystic fibrosis.~   "
275233|NCT00004286|"~     OBJECTIVES:~      I. Compare and evaluate the response to treatment with intravenous human immune globulin~     (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating~     polyneuropathy.~   "
275234|NCT00004285|"~     OBJECTIVES: I. Evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic~     modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end~     stage renal disease.~      II. Compare the efficacy of high versus low flux dialyzer membranes.~   "
275235|NCT00004284|"~     OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium~     phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with~     absorptive hypercalciuria.~      II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate~     to that of potassium citrate.~   "
275236|NCT00004278|"~     OBJECTIVES:~      I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates~     with symptomatic congenital cytomegalovirus infection with central nervous system disease.~   "
275237|NCT00004276|"~     OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in~     patients receiving antitubercular therapy.~      II. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of~     HIV and mycobacterial infections, and limits progression of HIV immunodeficiency.~      III. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or~     mycobacterial infections.~   "
275238|NCT00004275|"~     RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X~     chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may~     help girls with Turner's syndrome attain a more normal height. It is not yet known if growth~     hormone is more effective with or without oxandrolone for Turner's syndrome.~      PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who~     have growth hormone-treated Turner's syndrome.~   "
275239|NCT00004274|"~     RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X~     chromosome and do not produce estrogen. Giving estrogen is standard treatment for girls who~     have Turner's syndrome. Estrogen may be effective treatment for mental and social functioning~     problems experienced by girls with Turner's syndrome.~      PURPOSE: Clinical trial to study the effectiveness of long term estrogen therapy on mental~     and social functioning in girls who have Turner's syndrome.~   "
275241|NCT00004266|"~     OBJECTIVES:~      I. Establish a long-term working relationship between clinical investigators and the~     Minnesota American Indian community.~      II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and~     nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in~     Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria.~      III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A~     reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol~     Education Program in preventing nephropathy and vascular diseases in these patients.~   "
275242|NCT00000170|"~     -  To determine whether the success rate with drug treatment (atropine) of amblyopia due to~          strabismus or anisometropia in patients less than 7 years old is equivalent to the~          success rate with occlusion (patching) therapy~        -  To develop more precise estimates of the success rates of amblyopia treatment~        -  To identify factors that may be associated with successful treatment of amblyopia~        -  To collect data on the course of treated amblyopia to provide more precise estimates of~          treatment effects than are now available~      Extended Follow up of Study Patients~        -  Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15~          years in patients diagnosed with amblyopia before age 7 years.~        -  Secondary: To determine whether the long-term visual acuity outcome at age 10 years and~          at age 15 years differs between patients who received patching followed by best clinical~          care and patients who received atropine followed by best clinical care~   "
275243|NCT00000169|"~     To compare and contrast normal eye growth, ocular component development, and refractive error~     development in Hispanic, African-American, and Asian schoolchildren with what happens in~     Caucasian children from the Orinda Longitudinal Study of Myopia.~      To investigate risk factors for the development of myopia.~      To conduct DNA-based studies on nearsighted children and their families.~   "
275244|NCT00000168|"~     To monitor trends over time, in the incidence of CMV retinitis and other ocular complications~     of AIDS~      To determine the effect of highly active anti-retroviral therapy (HAART)-induced immune~     status on the risk of developing CMV retinitis and other ocular complications of AIDS~      To determine the characteristics (clinical, virologic, hematologic, and biochemical) of a~     population at high risk for CMV retinitis and other ocular complications of AIDS~      To evaluate the effects of treatments for CMV retinitis and other ocular complications on~     visual function, quality of life, and survival.~   "
275245|NCT00000167|"~     To determine whether application of low-intensity laser treatment of eyes with drusen in the~     macula can prevent later complications of age-related macular degeneration and thereby~     preserve visual function.~   "
275246|NCT00000163|"~     To observe the early course of congenital esotropia, a form of childhood strabismus. This~     will determine the probability of spontaneous resolution. Researchers then will try to~     correlate this finding with various aspects of the esotropia such as the (1) size of the~     esotropia, (2) variability, and (3) presence of hyperopia. This information will be used to~     determine the feasibility of conducting a clinical trial to assess the benefit of early~     surgery for congenital esotropia and, if feasible, to refine eligibility criteria for the~     trial.~   "
275247|NCT00000162|"~     To determine whether scatter argon laser photocoagulation can prevent the development of~     neovascularization.~      To determine whether peripheral scatter argon laser photocoagulation can prevent vitreous~     hemorrhage.~      To determine whether macular argon laser photocoagulation can improve visual acuity in eyes~     with macular edema reducing vision to 20/40 or worse.~   "
275248|NCT00000161|"~     To determine whether vitamin E supplementation reduces the risk of cataract and age-related~     macular degeneration (AMD) in women.~      To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women.~      To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in~     women.~      To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in~     women.~      To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol~     intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index,~     and diabetes.~   "
275249|NCT00000160|"~     To determine whether photocoagulation helps prevent severe visual loss from proliferative~     diabetic retinopathy.~      To determine whether a difference exists in the efficacy and safety of argon versus xenon~     photocoagulation for proliferative diabetic retinopathy.~   "
275250|NCT00000159|"~     To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase~     inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons~     with insulin-dependent diabetes.~   "
275251|NCT00000158|"~     To evaluate laser treatment of choroidal neovascularization (CNV) through randomized,~     controlled clinical trials. The Macular Photocoagulation Study (MPS) consisted of three sets~     of randomized, controlled clinical trials. Change in best-corrected visual acuity from~     baseline was the primary outcome for all MPS trials. Other measures of vision are evaluated~     in each set of trials. The purpose of each is described below.~      Argon Study: To determine whether argon blue-green laser photocoagulation of leaking abnormal~     blood vessels in choroidal neovascular membranes outside the fovea (200 to 2,500 microns from~     the center of the foveal avascular zone [FAZ]) is of benefit in preventing or delaying loss~     of central vision in patients with age-related (senile) macular degeneration (AMD), presumed~     ocular histoplasmosis (POH), and idiopathic neovascular membranes (INVM). A separate trial~     was conducted for each of the three underlying conditions.~      Krypton Study: To determine whether krypton red laser photocoagulation of choroidal~     neovascular lesions with the posterior border 1 to 199 microns from the center of the FAZ is~     of benefit in preventing or delaying large losses of visual acuity in patients with AMD, POH,~     and INVM. A separate trial was conducted for each of the three underlying conditions.~      Foveal Study: To determine whether laser photocoagulation is of benefit in preventing or~     delaying further visual acuity loss in patients with new (never treated) or recurrent~     (previously treated with laser photocoagulation) choroidal neovascularization under the~     center of the FAZ. Two separate trials, one for each type of lesion, were carried out.~   "
275252|NCT00000157|"~     To determine whether 325 mg of aspirin taken on -alternate days reduces the risk of~     developing cataract among male U.S. physicians who were aged 40 to 84 in 1982.~      To identify potential risk factors for cataract development, such as age, blood pressure,~     blood cholesterol, height, diabetes, medication use, and history of previous eye trauma or~     surgery.~   "
275254|NCT00000155|"~     To describe the clinical course of keratoconus and to describe the relationships among its~     visual and physiological manifestations, including high- and low-contrast visual acuity,~     corneal curvature, slit lamp biomicroscopic findings, corneal scarring, and quality of life.~      To identify risk factors and protective factors that influence the severity and progression~     of keratoconus.~   "
275255|NCT00000154|"~     To compare two therapies, early vitrectomy and conventional management, for recent severe~     vitreous hemorrhage secondary to diabetic retinopathy. Conventional management includes~     vitrectomy if hemorrhage fails to clear during a waiting period of 6 to 12 months or if~     retinal detachment involving the center of the macula develops at any time.~      To compare early vitrectomy and conventional management in eyes that have good vision but a~     poor prognosis because they are threatened with hemorrhage or retinal detachment from very~     severe proliferative retinopathy.~      To study the natural history of severe proliferative diabetic retinopathy.~   "
275256|NCT00000153|"~     To evaluate whether red krypton laser treatment is as effective at causing regression of~     diabetic disc neovascularization as treatment with the blue-green argon laser, when both~     lasers are used with identical panretinal photocoagulation patterns.~      To assess the vision of study patients.~      To test the feasibility of a prototype NEI-sponsored multicenter clinical trial in which~     participating clinics are not financially reimbursed and in which both the Coordinating and~     Fundus Photograph Reading Center functions are carried out by staff of the NEI Biometry and~     Epidemiology Program.~   "
275257|NCT00000152|"~     To determine whether 50 mg of beta-carotene taken every other day reduces the risk of~     developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40~     to 84 in 1982.~      To investigate the possible relationship of AMD with other antioxidants, including selenium~     and vitamins A, C, and E.~      To identify potential risk factors for development of AMD. Possible risk factors include~     height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking,~     iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.~   "
275258|NCT00000151|"~     To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in~     delaying or preventing progression of early diabetic retinopathy to more severe stages of~     visual loss and blindness.~      To help determine the best time to initiate photocoagulation treatment in diabetic~     retinopathy.~      To monitor closely the effects of diabetes mellitus and of photocoagulation on visual~     function.~      To produce natural history data that can be used to identify risk factors and test etiologic~     hypotheses in diabetic retinopathy.~   "
275259|NCT00000150|"~     To determine whether surgical removal of subfoveal choroidal neovascularization (CNV) and~     associated hemorrhage in patients with age-related macular degeneration (AMD), the ocular~     histoplasmosis syndrome (OHS), or idiopathic CNV stabilizes or improves vision more often~     than observation.~      To determine how surgical removal compared to observation of subfoveal CNV due to AMD, OHS,~     or idiopathic causes changes the patient's perception of health- and vision-related quality~     of life, as measured by telephone interview using the Medical Outcomes Survey Short Form-36~     (MOS SF-36) instrument, the Hospital Anxiety and Depression Scale, and the National Eye~     Institute Visual Function Questionnaire (NEI VFQ-25).~      To determine whether randomized trials of surgery are warranted for patients with subfoveal~     CNV associated with age-related macular degeneration not suitable for laser treatment.~   "
275260|NCT00000149|"~     To compare the long-term effect of treating newly diagnosed open-angle glaucoma with standard~     medical treatment versus filtration surgery.~   "
275261|NCT00000148|"~     To assess the long-range outcomes of sequences of interventions involving trabeculectomy and~     argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma.~   "
275262|NCT00000147|"~     To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.~      To determine the natural history of vision in patients who suffer optic neuritis.~      To identify risk factors for the development of multiple sclerosis in patients with optic~     neuritis.~   "
275263|NCT00000146|"~     To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.~      To determine the natural history of vision in patients who suffer optic neuritis.~      To identify risk factors for the development of multiple sclerosis in patients with optic~     neuritis.~   "
275264|NCT00000145|"~     To assess the clinical course, prognosis, and risk factors of age-related macular~     degeneration (AMD) and cataract.~      To evaluate, in randomized clinical trials, the effects of pharmacologic doses of (1)~     antioxidants and zinc on the progression of AMD and (2) antioxidants on the development and~     progression of lens opacities.~   "
275265|NCT00000144|"~     To compare the safety and long-term efficacy of argon laser treatment of the trabecular~     meshwork with standard medical treatment for primary open-angle glaucoma.~   "
275266|NCT00000143|"~     To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir~     intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss.~      To compare a treatment regimen that incorporates highly active local therapy (ganciclovir~     device) with a treatment regimen that does not.~   "
275267|NCT00000142|"~     To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously~     known as HPMPC) for the treatment of retinitis.~   "
275268|NCT00000140|"~     To compare, through a randomized, multicenter surgical trial, the postoperative tamponade~     effectiveness of intraocular silicone oil with that of an intraocular long-acting gas~     (initially sulfur hexafluoride [SF 6 ], later perfluoropropane [C 3 F 8 ]) for the management~     of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using vitrectomy~     and associated techniques.~      To evaluate the ocular complications that result from the use of silicone oil and gas.~   "
275269|NCT00000139|"~     To determine whether early treatment (with oral acyclovir) of herpes simplex virus (HSV)~     ulcerations of the corneal epithelium prevents progression to the blinding complications of~     stromal keratitis and iridocyclitis.~      To determine the efficacy of low-dose oral acyclovir in preventing recurrent HSV eye~     infection in patients with previous episodes of herpetic eye disease.~      To determine the role of external factors (such as ultraviolet light or corneal trauma) and~     behavioral factors (such as life stress) on the induction of ocular recurrences of HSV eye~     infections and disease.~   "
275270|NCT00000138|"~     To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal~     keratitis in conjunction with topical trifluridine.~      To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in~     patients receiving concomitant topical corticosteroids and trifluridine.~      To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in~     conjunction with treatment with topical corticosteroids and trifluridine.~   "
275271|NCT00000137|"~     To determine whether histocompatibility matching of corneal transplant donors and recipients~     can reduce the incidence of graft rejection in high-risk patients.~   "
275272|NCT00000136|"~     To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial~     treatment of patients with cytomegalovirus (CMV) retinitis.~   "
275273|NCT00000135|"~     To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as~     adjunct therapy for controlling CMV retinitis.~   "
275274|NCT00000134|"~     To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV~     retinitis who have been previously treated but whose retinitis either is nonresponsive or has~     relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and~     (3) combination foscarnet and ganciclovir.~      To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis:~     (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.~   "
275275|NCT00000133|"~     To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in~     certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness~     from ROP.~      To determine the long-term outcome for eyes that had severe (threshold) ROP, both with and~     without cryotherapy.~   "
275276|NCT00000132|"~     The primary purpose is to compare the effect of immediate therapy to lower the intraocular~     pressure (IOP) versus late or no treatment on the progression of newly detected open-angle~     glaucoma, as measured by increasing visual field loss and/or optic disc changes.~      The secondary purposes are to determine the extent of IOP reduction attained by treatment, to~     explore factors that may influence glaucoma progression, and to describe the natural history~     of newly detected glaucoma.~   "
275277|NCT00000131|"~     To determine whether photocoagulation therapy can help prevent iris neovascularization in~     eyes with central vein occlusion (CVO) and evidence of ischemic retina.~      To assess whether grid-pattern photocoagulation therapy will reduce loss of central visual~     acuity due to macular edema secondary to CVO.~      To develop new data describing the course and prognosis for eyes with CVO.~   "
275278|NCT00000130|"~     To determine the role of initial pars plana vitrectomy in the management of postoperative~     bacterial endophthalmitis.~      To determine the role of intravenous antibiotics in the management of bacterial~     endophthalmitis.~      To determine which factors, other than treatment, predict outcome in postoperative bacterial~     endophthalmitis.~   "
275279|NCT00000129|"~     To determine whether radial keratotomy is effective in reducing myopia.~      To detect complications of the surgery.~      To discover patient characteristics and surgical factors affecting the results.~      To determine the long-term safety and efficacy of the procedure.~   "
275280|NCT00000128|"~     To test the hypothesis that correction with bifocal spectacle lenses rather than~     single-vision lenses will slow the progression of myopia in children with near-point~     esophoria. The primary outcome variable is cycloplegic refraction as measured with an~     automated refractor. Axial length is measured with ultrasound in order to test the corollary~     hypothesis that use of bifocals will slow ocular growth in these myopic children. We will~     also examine the amount of close work performed by subjects and the degree of parental myopia~     as factors that may influence myopia progression.~   "
275281|NCT00000127|"~     To assess the safety and efficacy of optic nerve sheath decompression surgery for~     non-arteritic ischemic optic neuropathy (NAION).~   "
275282|NCT00000126|"~     To follow all patients enrolled in the original Ischemic Optic Neuropathy Decompression Trial~     (IONDT) to determine (1) the incidence of non-arteritic ischemic optic neuropathy (NAION) in~     the second eye, (2) changes in visual acuity over time in both the study and second eye, and~     (3) other aspects of the natural history of NAION.~   "
275283|NCT00000125|"~     To determine whether medical reduction of intraocular pressure prevents or delays the onset~     of glaucomatous visual field loss and/or optic disc damage in ocular hypertensive~     participants judged to be at moderate risk for developing open-angle glaucoma.~      To produce natural history data to assist in identifying patients at most risk for developing~     open-angle glaucoma and those most likely to benefit from early medical treatment.~      To quantify risk factors for developing open-angle glaucoma among ocular hypertensive~     individuals.~   "
275284|NCT00000124|"~     To evaluate therapeutic interventions for patients who have choroidal melanoma, the most~     common primary eye cancer affecting adults, and to assess the potential life-preserving as~     well as sight-preserving role of radiation therapy.~      To determine which of two standard treatments, removal of the eye or brachytherapy, is more~     likely to prolong survival of eligible patients with medium-sized choroidal melanoma.~      To determine whether preoperative radiation prolongs life for patients whose eyes with large~     choroidal melanoma are enucleated.~   "
275285|NCT00000123|"~     To evaluate the relative efficacy of orthokeratology, primarily by assessment of changes in~     central corneal thickness, astigmatism, visual acuity, endothelial cell density, and corneal~     curvature.~      To evaluate the relative safety of orthokeratology, primarily by assessment of changes in~     central corneal thickness, astigmatism, visual acuity, endothelial cell density, induced~     corneal edema, and epithelial staining.~      To assess the duration of any orthokeratology treatment effect.~      To study the mechanisms by which refractive error and visual acuity changes occur, in~     particular the contribution that comes from changes in corneal curvature and shape.~      To determine whether there were any predisposing ocular factors that could be used to predict~     which subjects will experience changes or complications.~   "
275286|NCT00000122|"~     To determine whether postoperative subconjunctival injections of 5-fluorouracil (5-FU)~     increase the success rate of filtering surgery in patients at high risk for failure after~     standard glaucoma filtering surgery.~   "
275391|NCT00000261|"~     The purpose of this study is to evaluate the effects of alcohol history on the subjective and~     reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects~     underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of~     intervention.~   "
275287|NCT00000121|"~     To determine whether the preoperative use of prisms in eyeglasses can improve the outcome of~     surgery for acquired esotropia, a type of strabismus.~      To determine whether patients who respond to prism adaptation by developing a new stable~     angle of -deviation have a better surgical result than do patients who do not respond to~     prism adaptation.~      To determine whether patients who respond to prism adaptation are more accurately corrected~     by operating for the prism-adapted angle or the original angle of deviation.~      To determine the usefulness of certain input variables (e.g., age at the time of surgery,~     size of the deviation, visual acuity, binocular function, refractive error) in predicting~     which patients are more likely to benefit from prism adaptation.~   "
275288|NCT00000120|"~     To compare the effectiveness of silver nitrate drops, erythromycin ointment, or no medication~     in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye~     infections.~      To compare side effects of the two prophylactic agents.~   "
275289|NCT00000119|"~     To investigate the safety and efficacy of a heparin surface-modified intraocular lens in~     patients with uveitis undergoing cataract surgery.~      To evaluate the safety and efficacy of intraocular lens implantation in patients with severe~     uveitis.~   "
275290|NCT00000118|"~     To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system~     for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired~     immunodeficiency syndrome (AIDS).~   "
275291|NCT00000117|"~     To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than~     placebo in restoring lost visual function (visual acuity) in optic neuritis (ON).~      To determine the time course of recovery following IVIg administration. If the reports of~     IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can~     be confirmed, this would provide indirect evidence that IVIg may promote central nervous~     system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).~   "
275292|NCT00000116|"~     The purpose of this trial is to determine whether a nutritional supplement in addition to~     vitamin A will slow the course of retinitis pigmentosa.~   "
275293|NCT00000115|"~     To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular~     edema.~   "
275294|NCT00000114|"~     To determine whether supplements of vitamin A or vitamin E alone or in combination affect the~     course of retinitis pigmentosa.~   "
275295|NCT00000113|"~     To evaluate whether progressive addition lenses (PALs) slow the rate of progression of~     juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured~     by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by~     A-scan ultrasonography.~      To describe the natural history of juvenile-onset myopia in a group of children receiving~     conventional treatment (single vision lenses).~   "
275296|NCT00000358|"~     The purpose of this study is to determine the safety of lofexidine in the treatment of opiate~     withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to~     alleviate opiate withdrawal signs and symptoms.~   "
275297|NCT00000357|"~     The purpose of this study is to determine the efficacy of buprenorphine as a substitution~     pharmacotherapy for opiate dependence.~   "
275298|NCT00000356|"~     The purpose of this study is to determine the pharmacokinetics of L-alpha-acetylmethadol~     (LAAM) in adults transferred from methadone maintenance treatment for opiate dependence.~   "
275299|NCT00000355|"~     The purpose of this study is to evaluate the behavioral and physiological effects of~     buprenorphine and naloxone, both alone and in combination.~   "
275300|NCT00000354|"~     The purpose of this study is to determine the safety of lofexidine in the treatment of opiate~     withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to~     alleviate opiate withdrawal signs and symptoms.~   "
275301|NCT00000353|"~     The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone~     sublingual tablet formulation as an office-based therapy for opiate dependence treatment.~   "
275302|NCT00000352|"~     The purpose of this study is to determine if addition of dextromethorphan to a stable dose of~     methadone in opioid dependent subjects will significantly affect physical and psychological~     aspects of opioid tolerance.~   "
275303|NCT00000351|"~     Part II: Examine cognitive performance of stimulant abusers (methamphetamine and cocaine)~     during recovery by assessing their cognitive function at monthly intervals.~   "
275304|NCT00000350|"~     The purpose of this study is to determine whether DAT availability, assessed by WIN binding,~     in the striatum is altered in cocaine or methamphetamine dependence. To determine whether DA~     synthesis capacity, assessed by FDOPA uptake, in the striatum is altered in Coc or Meth~     dependence. To determine whether the PET tracers, WIN or FDOPA, will differentiate Meth~     induced alterations from those induced by Coc use. To determine whether the PET~     characterization of striatal alterations observed at 3-5 days since last drug use persists at~     least 3 months after last drug use.~   "
275305|NCT00000349|"~     The purpose of this study is to evaluate clinical safety issues pertaining to flupenthixol,~     to cocaine, and to their interaction, and to determine how pretreatment with flupenthixol~     modifies the subjective as well as physiological effects of cocaine. Taken together, these~     relatively D-1 selective agents can help determine the extent to which DA-1 binding affects~     the reinforcing effects of stimulants.~   "
275306|NCT00000348|"~     The purpose of this study is to evaluate safety issues pertaining to dihydrexidine (DHX), to~     cocaine, and to its interaction, and to determine how pretreatment with DHX modifies the~     subjective as well as physiological effects of cocaine infusion.~   "
275307|NCT00000347|"~     The purpose of this study is to evaluate pharmacological efficacy and clinical safety of~     risperidone in the treatment of cocaine and amphetamine dependence.~   "
275308|NCT00000346|"~     The purpose of this study is to characterize the cognitive performance of methamphetamine~     abusers by comparing them with cocaine abusers and normal controls.~   "
275309|NCT00000345|"~     The purpose of this study is to assess the safety of lofexidine in the treatment of~     opiate-dependent individuals.~   "
275310|NCT00000344|"~     The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone~     sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.~   "
275412|NCT00000239|"~     The purpose of this study is to examine if chronic buprenorphine administration will generate~     supersensitivity to opiates.~   "
275311|NCT00000343|"~     The purpose of this study is to identify the neurophysiologic indicators of cocaine or~     methamphetamine use and withdrawal, to examine the relationship between subjects' reports of~     depression, craving, and stimulant use, and neurophysiologic measures, and to identify~     neurophysiologic measures which can be used to identify new treatments for stimulant~     dependence.~   "
275312|NCT00000342|"~     The purpose of this study is to evaluate clinical safety and pharmacological efficacy in the~     treatment of cocaine dependence, to evaluate impact of treatment on craving, and to correlate~     evidence of baseline neurotoxic damage of cocaine with treatment outcome and clinical~     side-effects.~   "
275313|NCT00000341|"~     The purpose of this study is to evaluate the steady-state pharmacokinetics and~     bioavailability of buprenorphine sublingual tablets vs. sublingual solution.~   "
275314|NCT00000340|"~     The purpose of this study is to assess the efficacy of pemoline in treating cocaine and/or~     methamphetamine dependent adults with comorbid Adult Attention Deficit Hyperactivity Disorder~     (ADHD).~   "
275315|NCT00000339|"~     The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to~     cocaine and to its interaction, and to determine how pretreatment with risperidone modifies~     the subjective as well as physiological effects of cocaine.~   "
275316|NCT00000338|"~     The purpose of this study is to evaluate clinical safety issues pertaining to lisuride, to~     cocaine, and to its interaction in a chronic, crack dependent population, and to determine~     how pretreatment with lisuride modifies the subjective as well as physiological effects of~     cocaine.~   "
275317|NCT00000337|"~     The purpose of this study is to determine the effects of selegiline on the subjective and~     physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical~     safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack~     dependent population.~   "
275318|NCT00000336|"~     The purpose of this study is to evaluate the efficacy and clinical safety of selegiline in~     the treatment of cocaine dependence and to assess neurotoxicity (Magnetic Resonance Imaging,~     MRI) post-hoc as a possible variable for future stratification in clinical trials.~   "
275319|NCT00000335|"~     The purpose of this study is to determine if hyperactivity accompanies abrupt opiate~     withdrawal in heroin addicts, to determine if computerized solid state activity monitors are~     capable of quantifying hyperactivity, and to quantify the physical and affective symptoms~     occurring during abrupt withdrawal in heroin addicts and morphine's capacity to alleviate~     these symptoms.~   "
275320|NCT00000334|"~     The purpose of this study is to compare agonist and antagonist profile associated with~     buprenorphine vs. methadone during opiate withdrawal.~   "
275321|NCT00000333|"~     The purpose of this study is to compare the efficacy of benztropine (or DA reuptake~     inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.~   "
275322|NCT00000332|"~     The purpose of this study is to determine if nimodipine is more effective than placebo in~     reducing stimulated craving for cocaine in cocaine dependent individuals denied access to~     cocaine in inpatient unit.~   "
275323|NCT00000331|"~     The purpose of this study is to assess the abuse liability and examine the reinforcing~     effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy,~     non-drug dependent volunteers.~   "
275324|NCT00000330|"~     The purpose of this study is to assess the abuse liability and reinforcing effects of~     intravenous buprenorphine and buprenorphine/naloxone combinations in heroin-dependent~     volunteers~   "
275325|NCT00000329|"~     The purpose of this study is to assess the abuse liability and examine the reinforcing~     effects of intravenous buprenorphine and buprenorphine/naloxone combinations in~     buprenorphine-naloxone maintained volunteers~   "
275326|NCT00000328|"~     The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone~     combination tablet to methadone for opioid maintenance treatment.~   "
275327|NCT00000327|"~     The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF)~     buprenorphine/naloxone combination tablet administration and determine whether outcomes are~     improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in~     which take-home doses are given on intervening days.~   "
275328|NCT00000326|"~     The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone~     combination tablet for alternate-day dosing and determine whether multiples of the daily dose~     are necessary to maintain an effective alternate day dosing regimen.~   "
275329|NCT00000325|"~     To determine if acute assessments of profasi and factrel affect plasma cocaine levels and~     cocaine-induced behavioral changes in men.~   "
275330|NCT00000324|"~     The purpose of this study is to assess the efficacy of tryptophan vs. placebo, and voucher~     payments vs. a control condition, in the treatment of cocaine dependence.~   "
275331|NCT00000323|"~     The purpose of this study is to characterize the effects of enadoline compared to~     hydromorphone and butorphanol.~   "
275332|NCT00000322|"~     The purpose of this study is to evaluate efficacy of tyrosine as a treatment for~     methamphetamine dependence in an outpatient treatment setting providing group psychosocial~     interventions. Examine effect of tyrosine on abstinence, retention in treatment, and~     craving.~   "
275333|NCT00000321|"~     The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo~     on methamphetamine dependent gay men with AIDS.~   "
275334|NCT00000320|"~     The purpose of this study is to compare subject response to liquid vs. tablet formulations,~     to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate~     if dose response curve for tablet is equal to liquid form.~   "
275335|NCT00000319|"~     The purpose of this study is to evaluate the efficacy of treating opioid-dependent~     individuals with buprenorphine on a thrice-weekly schedule compared to daily dosing.~   "
275336|NCT00000318|"~     The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly~     schedule in a pilot clinical trial.~   "
275413|NCT00000238|"~     The purpose of this study is to assess the degree in which opioid-dependent outpatients~     discount the value of an additional maintenance dose of buprenorphine under differing states~     of opioid deprivation.~   "
275337|NCT00000317|"~     The purpose of this study is to develop models for early Phase II testing of potential~     medications for cocaine dependence: amoxapine, risperidone and other agents.~      The study was a controlled pilot trial of risperidone in opiate-dependent patients on~     methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine~     craving, and cocaine subjective effects in patients on methadone maintenance who abused~     cocaine and whether it had an acceptable side effect profile. This~   "
275338|NCT00000316|"~     The purpose of this study is to determine the density of DA transporters during prolonged~     cocaine abuse and during withdrawal from cocaine use. This aim will test the hypothesis that~     DA transporters are altered by cocaine abuse and reestablished during withdrawal.~   "
275339|NCT00000315|"~     The purpose of this study is to determine the density of DA transporters during prolonged~     cocaine abuse and during withdrawal from cocaine use. This aim will test the hypothesis that~     DA transporters are altered by cocaine abuse and reestablished during withdrawal.~   "
275340|NCT00000314|"~     The purpose of this study is to evaluate predictive value of M-CPP and fenfluramine~     challenges for outcome.~   "
275341|NCT00000313|"~     The purpose of this study is to evaluate the predictive value of serotonergic alterations for~     outcome.~   "
275342|NCT00000312|"~     The purpose of this study is to evaluate alterations in the serotonergic system in cocaine~     addicts and attempt to dissociate changes secondary to cocaine use from those associated with~     premorbid characteristics.~   "
275343|NCT00000311|"~     The purpose of this study is to evaluate whether the community reinforcement approach (CRA)~     plus contingency management (CM) is more effective overall than CRA only in reducing illicit~     opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up~     after completion of study protocol, and to compare the efficacy of maintenance on~     buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.~   "
275344|NCT00000310|"~     The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study~     measures incorporate an appropriate integration of behavioral and neurobiological indices.~   "
275345|NCT00000309|"~     The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study~     measures incorporate an appropriate integration of behavioral and neurobiological indices.~   "
275346|NCT00000308|"~     The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in~     cocaine dependent patients.~   "
275347|NCT00000307|"~     The purpose of this study is to evaluate naltrexone as an adjunct in alcoholic cocaine~     dependent patients; concurrent relapse prevention theory.~   "
275348|NCT00000306|"~     The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an~     adjunct in concurrent cocaine and opiate dependent patients.~   "
275349|NCT00000305|"~     The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology)~     interaction study.~   "
275350|NCT00000304|"~     The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an~     adjunct in cocaine treatment; an evaluation of the replacement strategy.~   "
275351|NCT00000303|"~     The purpose of this study is to empirically test a series of medications to: 1) determine~     each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective~     dose range for each medication. In this study, baclofen is tested.~   "
275352|NCT00000302|"~     The purpose of this study is to compare liquid and tablet buprenorphine formulations.~   "
275353|NCT00000301|"~     The purpose of this study is to empirically test a series of medications to: 1) determine~     each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective~     dose range for each medication. In this study, amantadine is tested.~   "
275354|NCT00000300|"~     The purpose of this study is to test therapeutic benefits of take-home LAAM. (1) Do subjects~     with take-home LAAM availability show increased clinical responsibility over subjects~     without; (2) Do subjects with take-home LAAM attempt diversion when random recall and other~     diversion safeguards are used; (3) Does treatment response correlate with background or drug~     use variables at intake, discharge, or during treatment?~   "
275355|NCT00000299|"~     The purpose of this study is to develop a clinical protocol to detoxify patients from opiates~     to naltrexone using buprenorphine and to develop pilot data for a grant application for a~     controlled study of the efficacy of the new clinical protocol for outpatients.~   "
275356|NCT00000298|"~     The purpose of this study is to determine target dose range of buprenorphine/naloxone~     combination tablet that provides therapeutic response in opiate addicts with low to moderate~     dependence, and to identify appropriate initial induction dose in opiate addicts with low to~     moderate dependence.~   "
275357|NCT00000297|"~     The purpose of this study is to investigate the effects of labetalol in response to~     intravenous nicotine~   "
275358|NCT00000296|"~     The purpose of this study is to determine the effects of cotinine with or without a~     transdermal nicotine replacement on tobacco withdrawal symptoms.~   "
275359|NCT00000295|"~     The purpose of this study is to investigate progesterone effects in female smokers~   "
275360|NCT00000294|"~     The purpose of this study is to examine carvedilol effects in response to cocaine.~   "
275361|NCT00000293|"~     The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use~     in depressed and non-depressed females with cocaine abuse/dependence.~   "
275362|NCT00000292|"~     The purpose of this study is to develop an experimental paradigm to examine acute withdrawal~     symptoms from cocaine.~   "
275363|NCT00000291|"~     The purpose of this study is to determine the effect of labetalol treatment on the subjective~     and physiological effects of cocaine.~   "
275364|NCT00000290|"~     The purpose of this study is to determine the HPA axis and adrenergic system activation in~     response to cocaine administration.~   "
275365|NCT00000289|"~     The purpose of this study is to determine the effects of various doses of ondansetron~     transdermal nicotine replacement on tobacco withdrawal symptoms.~   "
275366|NCT00000288|"~     The purpose of this study is to determine the effects of varying doses of cotinine on~     cigarette self-administration.~   "
275367|NCT00000287|"~     The purpose of this study is to pilot a relapse questionnaire and examine relapse patterns in~     female cocaine users.~   "
275392|NCT00000260|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. Comparisons~     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine the~     effects of different behavioral contingencies in modulating the reinforcing effects of~     nitrous oxide in healthy volunteers.~   "
275393|NCT00000259|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. Comparisons~     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine~     sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and~     psychomotor performance.~   "
275394|NCT00000258|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. Comparisons~     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To evaluate the~     role of instructions in nitrous oxide subjective effects and choice.~   "
275395|NCT00000257|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. Comparisons~     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To determine~     effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous~     oxide in healthy volunteers.~   "
275396|NCT00000256|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. Comparisons~     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine~     reinforcing effects of brief exposures to nitrous oxide in healthy volunteers.~   "
275397|NCT00000255|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. To examine~     differential acute tolerance development to effects of nitrous oxide in humans.~   "
275398|NCT00000254|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. To test the~     hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water~     immersion pain in healthy volunteers.~   "
275399|NCT00000253|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. To examine the~     subjective, psychomotor, and reinforcing effects of nitrous oxide in healthy volunteers. This~     is a dose-response analysis.~   "
275400|NCT00000252|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. To examine the~     lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of~     nitrous oxide in healthy volunteers.~   "
275401|NCT00000251|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. To evaluate the~     acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide~     combinations in healthy volunteers.~   "
275402|NCT00000250|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. To evaluate:~     cold water immersion modulates the reinforcing effects of nitrous oxide in healthy~     volunteers.~   "
275403|NCT00000249|"~     The purpose of this study is to conduct experiments to examine subjective and reinforcing~     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug~     abusers and preference procedures will be used to assess reinforcing effects. To examine~     effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans.~   "
275404|NCT00000248|"~     The purpose of this study is to evaluate the efficacy and safety of pergolide for treatment~     of cocaine dependence.~   "
275405|NCT00000246|"~     The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist,~     flumazenil, will reduce acute benzodiazepine withdrawal.~   "
275406|NCT00000245|"~     The purpose of this study is to confirm whether a blood level ceiling exists on~     desipramine effect in cocaine abuse.~   "
275407|NCT00000244|"~     The purpose of this study is to evaluate the effects of IV dynorphin in humans during acute~     heroin abstinence, in order to determine that dynorphin suppresses acute opiate withdrawal,~     reduces opiate craving, and is safe at doses required to produce the above effects.~   "
275408|NCT00000243|"~     Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were~     previously maintained on methadone. The purpose of this study is to determine the effects of~     different doses of buprenorphine/naloxone in treating opioid dependent individuals who were~     previously maintained on methadone.~   "
275409|NCT00000242|"~     The purpose of this study is to compare the efficacy of carbamazepine in treatment of~     cocaine-dependence in patients with affective disorders.~   "
275410|NCT00000241|"~     The purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate~     for treatment of methamphetamine dependence. Also, study will compare flupenthixol with~     desipramine in blocking methamphetamine self-administration.~   "
275411|NCT00000240|"~     The purpose of this study is to test combined buprenorphine and behavioral treatment with and~     without contingent reinforcement on opioid and cocaine abstinence.~   "
275415|NCT00000236|"~     The purpose of this study is to examine the interactions between buprenorphine and~     naltrexone, and to assess how they may directly impact the clinical issues involving:~     transferring patients from buprenorphine to naltrexone, developing a non-abusable form of~     buprenorphine, and enhancing patient acceptability of naltrexone.~   "
275416|NCT00000235|"~     The purpose of this study is to determine if six times daily buprenorphine dose is effective~     in achieving 120 hour buprenorphine dosing.~   "
275417|NCT00000234|"~     The purpose of this study is to evaluate open buprenorphine dosing with dose choice after~     open exposure.~   "
275418|NCT00000233|"~     The purpose of this study is to determine how subjects will make changes in the amount of~     medication received when given a monetary alternative to buprenorphine.~   "
275419|NCT00000232|"~     The purpose of this study is to determine if four times a subjects' daily maintenance dose~     will hold for 120 hours without changes in agonist and antagonist effects.~   "
275420|NCT00000231|"~     The purpose of this study is to evaluate buprenorphine and behavioral treatment with and~     without contingent payment on compliance with pro-social activities. In addition, we will~     examine whether blind naltrexone dosing is effective in indicating naltrexone consumption.~   "
275421|NCT00000230|"~     The purpose of this study is to evaluate buprenorphine and behavioral treatment with and~     without contingent payment on compliance with naltrexone.~   "
275422|NCT00000229|"~     The purpose of this study is to compare overall treatment outcome between behavioral versus~     enhanced behavioral treatment types.~   "
275423|NCT00000228|"~     The purpose of this study is to compare overall treatment outcome between behavioral versus~     standard treatment types.~   "
275424|NCT00000227|"~     The purpose of this study is to evaluate open buprenorphine dosing with dose choice.~   "
275425|NCT00000226|"~     The purpose of this study is to determine if four times a subjects daily maintenance dose~     will hold for 96 hours without changes in agonist and antagonist effects under open dosing~     conditions.~   "
275426|NCT00000225|"~     The purpose of this study is to determine if four times a subject's daily maintenance dose~     will hold for 96 hours without changes in agonist and antagonist effects.~   "
275427|NCT00000224|"~     The purpose of this study is to evaluate buprenorphine blockade challenge.~   "
275428|NCT00000223|"~     The purpose of this study is to determine if three times a subject's daily maintenance dose~     will hold for 72 hours without changes in agonist and antagonist effects.~   "
275429|NCT00000222|"~     The purpose of this study is to determine if two times a subject's daily maintenance dose~     will hold for 48 hours without changes in agonist and antagonist effects.~   "
275430|NCT00000221|"~     The purpose of this study is to determine if two times a subject's daily maintenance dose~     will hold for 48 hours without changes in agonist and antagonist effects.~   "
275431|NCT00000220|"~     The purpose of this study is to determine an optimal detoxification dose reduction schedule~     with buprenorphine.~   "
275432|NCT00000219|"~     The purpose of this study is to examine the effects in buprenorphine dose alterations in~     opioid dependent individuals being maintained on buprenorphine.~   "
275433|NCT00000218|"~     The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine~     craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric~     disorders.~   "
275434|NCT00000217|"~     The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine~     craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric~     disorders.~   "
275435|NCT00000216|"~     The purpose of this study is to compare the clinical efficacy of maintenance on low and high~     doses of buprenorphine with methadone for cocaine abusing opiate addicts.~   "
275436|NCT00000215|"~     The purpose of this study is to evaluate the effects of pergolide on cocaine taking and on~     the physiological and subjective effects of cocaine, including cocaine craving in non-opiate~     dependent cocaine users.~   "
275437|NCT00000214|"~     The purpose of this study is to evaluate the effects of buprenorpine on cocaine taking and on~     the physiological and subjective effects of cocaine, including cocaine craving in non-opiate~     dependent cocaine users.~   "
275438|NCT00000213|"~     The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine~     taking and on the physiological and subjective effects of cocaine, including cocaine craving.~   "
275439|NCT00000212|"~     The purpose of this study is to evaluate the effects of desipramine DMI maintenance on~     cocaine taking and on the physiological and subjective effects of cocaine, including cocaine~     craving.~   "
275440|NCT00000211|"~     The purpose of this study is to assess the safety and effectiveness of buprenorphine for~     treatment of concurrent intravenous heroin and cocaine dependence.~   "
275441|NCT00000210|"~     The purpose of this study is to assess the safety and effectiveness of buprenorphine for~     treatment of concurrent intravenous heroin and cocaine dependence.~   "
275442|NCT00000209|"~     The purpose of this study is to explore the feasibility of extending the dosing interval of~     well maintained buprenorphine patients to 48 and 72 hours, leading to eventual 3 times/week~     dosing.~   "
275443|NCT00000208|"~     The purpose of this study is to explore ways to cross patients over from methadone to~     buprenorphine.~   "
275444|NCT00000207|"~     The purpose of this study is to test the efficacy and safety of buprenorphine.~   "
275445|NCT00000206|"~     The purpose of this study is to detect increasing medication dose results in heroin cessation~     for patients still using, to determine if decreasing medication dose in patients unable to~     tolerate medication dose increases retention, and to determine if blood levels of methadone~     or buprenorphine correlate with clinical response.~   "
275446|NCT00000205|"~     The purpose of this study is to compare the efficacy of buprenorphine versus methadone.~   "
275447|NCT00000204|"~     The purpose of this study is to evaluate buprenorphine in a medical maintenance model three~     times a week.~   "
275448|NCT00000203|"~     The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence~     and cocaine abuse.~   "
275449|NCT00000202|"~     The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in~     treatment of opiate and cocaine dependence.~   "
275451|NCT00000200|"~     The purpose of this study is to compare the effects of buprenorphine or methadone maintenance~     on cocaine taking and on the physiological and subjective effects of cocaine, including~     cocaine craving, in opiate-dependent cocaine users.~   "
275452|NCT00000199|"~     The purpose of this study is to follow patients in Phase I of an inpatient study in an eight~     week open label assessment of piracetam in an outpatient treatment program.~   "
275453|NCT00000198|"~     The purpose of this study is to evaluate the effects of IV cocaine administration in cocaine~     dependent subjects maintained on piracetam while they are residing in an inpatient addictions~     treatment research unit and to subsequently follow these patients in an eight week open label~     assessment of piracetam in an outpatient treatment program.~   "
275454|NCT00000197|"~     The purpose of this study is to evaluate the safety and efficacy of propanolol in the early~     treatment of cocaine dependence.~   "
275455|NCT00000196|"~     The purpose of this study is to determine the effect of acute naltrexone pretreatment on the~     response to yohimbine in healthy volunteers.~   "
275456|NCT00000195|"~     The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on~     the response to yohimbine in healthy volunteers.~   "
275457|NCT00000194|"~     The purpose of this study is to study the effects of cycloserine on naloxone-precipitated~     opiate withdrawal.~   "
275458|NCT00000193|"~     The purpose of this study is to evaluate the effects of gamma hydroxybutyric on~     naloxone-precipitated opiate withdrawal.~   "
275459|NCT00000192|"~     The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated~     opiate withdrawal.~   "
275460|NCT00000191|"~     The purpose of this study is to assess carbamazepine as a pharmacotherapy for cocaine~     dependence.~   "
275461|NCT00000190|"~     The purpose of this study is to establish the use of parotid saliva as a means of detecting~     and quantifying cocaine and its metabolites.~   "
275462|NCT00000189|"~     The purpose of this study is to test antidepressant medication, gepirone, as a~     pharmacotherapy for cocaine dependent subjects.~   "
275463|NCT00000188|"~     The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine~     dependence.~   "
275464|NCT00000187|"~     The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine~     dependence.~   "
275465|NCT00004640|"~     The purpose of this study is to determine if regular rinsing with chlorhexidine is effective~     as a long-term preventive method for reducing the incidence of tooth loss in low income older~     adults. The true end-point of the study is tooth loss after five years of regular rinsing~     with chlorhexidine or a placebo; surrogate endpoints are periodontal disease, root and~     coronal decay.~   "
275466|NCT00004639|"~     Compare the outcome of two primary surgeries techniques (von Langenbeck and Furlow double~     z-plasty) performed on children with cleft lip/palate to determine if one results in~     significantly better velopharyngeal competency for speech.~   "
